Science.gov

Sample records for achieve product safety

  1. A Product Safety Primer

    ERIC Educational Resources Information Center

    Brown, Mary Anne Symons

    1975-01-01

    The article offers an overview of the product safety issue and offers ideas for helping students develop product safety awareness. The role of the Consumer Product Safety Commission and safety legislation are discussed. (MW)

  2. Consumer Product Safety Commission

    MedlinePlus

    ... Lumber Liquidators Agrees To Not Resume Sales of Inventory of Chinese-Made Laminate Flooring, Continue Comprehensive Testing ... Safety Report an Unsafe Product Join Neighborhood Safety Network View Injury Statistics Put CPSC Recalls on Your ...

  3. Consumer Product Safety Bills.

    ERIC Educational Resources Information Center

    American Enterprise Inst. for Public Policy Research, Washington, DC.

    This legislative analysis of the actions of the 92nd Congress concerning consumer product safety bills, current as of March 20, 1972, presents briefly the background of Congressional investigations in this area. Describing in detail four major bills which focus on the establishment of an independent government agency regulating consumer products…

  4. [Drug safety--achievable goal or utopia?].

    PubMed

    Kimbel, K H

    1976-09-01

    The new German Drug Law, recently passed by the Bundstag (House of Representatives) endeavors to assure safety in drug distribution and use, especially to guarantee the harmlessness of drugs according to the regulations provided by the law. The following contribution tries to analyze how far we have come up to now as to a safe use of drugs, which improvements are possible, what they will cost, and finally who of us must contribute towards a rational compromise between therapeutic success and unavoidable risk.

  5. How to Achieve Next-Generation Public Safety Networks

    SciTech Connect

    Juan D. Deaton

    2008-07-01

    Cellular technologies have dramatically affected our culture and the way we communicate. High-feature cellular handsets have enabled a cornucopia of new addictive information services. Meanwhile, public safety workers frequently are given antiquated wireless technologies, some systems more than 15 years old, to perform the important job of saving the lives of others while risking their own. Achieving nationwide interoperability and migrating public safety to next generation networks is a complicated, variegated problem that requires solutions in multiple arenas. Using the strategic solutions of cellular communication networks with backup capabilities, public safety data prioritization mechanisms, software development standards, and a public safety MVNO.

  6. Consumer Product Safety Commission

    MedlinePlus

    ... En español Samsung Expands Recall of Galaxy Note7 Smartphones Based on Additional Incidents with Replacement Phones Serious ... for Failure to Report Defective Single Cup Coffeemakers Business Education Small businesses can determine which consumer product ...

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Monitoring product safety in the postmarketing environment

    PubMed Central

    Dieck, Gretchen S

    2013-01-01

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

  13. 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

  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 1115.8 - Compliance with product safety standards.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Compliance with product safety standards. 1115.8 Section 1115.8 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY... product safety standards. (a) Voluntary standards. The CPSA and other federal statutes administered by...

  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. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  18. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  19. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  20. 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...

  1. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

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

    ERIC Educational Resources Information Center

    Consumer Product Safety Commission, Washington, DC.

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

  3. Chemical safety of meat and meat products.

    PubMed

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

    2010-09-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

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

    ERIC Educational Resources Information Center

    Feldman, Laurence P.

    1977-01-01

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

  6. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... safety; (5) A document describing the manner in which product architecture satisfies safety requirements... not compromised as a result of any such change. (Software changes involving safety functional... arrangements with hardware and software suppliers for immediate notification of any and all safety...

  7. 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…

  8. 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…

  9. 78 FR 57570 - Safety Zone; Motion Picture Production; Chicago, Illinois

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-19

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

  10. 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.

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

    PubMed

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

    2010-05-01

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

  12. 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.

  13. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... description of the product functionality and information flows; (4) A safety requirements document, including... product must demonstrate that operation of the product, as modified by any predefined change, satisfies... not compromised as a result of any such change. (Software changes involving safety...

  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. 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.

  16. Linking production to safety: boosting productive performance through behavior-based safety.

    PubMed

    Lees, Howard; Faulkner, Bruce

    2010-01-01

    Construction continues to have the largest number of fatal and major injuries among industry groups and the general rates have shown only a small amount of change over the last number of years. Safety processes can (and do) fail, resulting in injuries and incidents. Behavioral science uses data and analysis to come to conclusions about what is actually happening. Therefore, objectivity is at the core of behavioral science. This science of behavior can help us produce more effective implementations of safety solutions. B-BS processes recognize the workplace environment as the dominant factor in the creation of safe working. This focus on behavior needs to be co-ordinated with the elimination of work hazards. This paper will discuss the history, successes, and failures of B-BS, and suggest fertile areas for improving traditional safety practices. The natural effect of the pairing of a successful B-BS roll out with production occurs because the leadership is now much educated regarding human behavior. The interest and attention to planning 'how' things get done on sites is much greater when B-BS exists. This paper will discuss how roll out of B-BS has also resulted in improvements in production and early completion rates of construction Projects.

  17. 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

  18. 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…

  19. 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

  20. 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

  1. 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…

  2. 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

  3. Genomics for food safety and sustainable animal production.

    PubMed

    Harlizius, Barbara; van Wijk, Rik; Merks, Jan W M

    2004-09-30

    There is a growing concern in society about the safety of animal-derived food, the health and welfare of farm animals and the sustainability of current animal production systems. Along farm animal, breeding genomics may contribute to a solution for these concerns. The use of genomic analysis tools, to achieve genetic progress in typical out-bred populations of farm animals, seems to be more difficult compared to 'model' organisms or plants. However, identification of positional candidate genes may be accelerated by linkage disequilibrium (LD) mapping. Recording of sustainable traits requires a large financial and logistic input and the economic advantages for the market are not as clear as for traditional selection traits. Examples show that the major genes causing variability for similar traits in different species are rarely the same. Therefore, for breeding purposes genomic analysis of the species of interest is needed. The fundamental knowledge obtained on the genetic architecture of complex traits will open new perspectives for the use of DNA tests in selection schemes. For food safety and traceability, DNA-based techniques evolve for monitoring and early warning systems.

  4. 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…

  5. 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)

  6. 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.

  7. 42 CFR 3.204 - Privilege of patient safety work product.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  8. 42 CFR 3.204 - Privilege of patient safety work product.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  9. 42 CFR 3.204 - Privilege of patient safety work product.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  10. 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)...

  11. 42 CFR 3.204 - Privilege of patient safety work product.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  12. 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.

  13. Food Safety Practices in the Egg Products Industry.

    PubMed

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

    2016-07-01

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

  14. Do safety issues of plasma products constrain self-sufficiency?

    PubMed

    Savidge, G F

    1994-12-01

    The ultimate responsibility for selecting and administering plasma products to patients rests with the prescribing physician, and it is for him/her to choose the safest product available. However, liability for a product with a full licence rests exclusively with the licence holder. After the problems of HIV and hepatitis C the safety of plasma-derived products has become of paramount importance. Particularly in the public sector, financial, strategic and political obstacles may adversely influence the quantity, quality and safety of plasma collection. The safety of blood products can be substantially enhanced by the harmonization of technical standards across both public and private sectors, thus supporting EC Directive 89/381. Additionally, the goal of European rather than national self-sufficiency should be encouraged.

  15. 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:

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

    PubMed

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

    2011-10-01

    The U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) has a specific lethality performance standard for ready-to-eat products. To assist meat processing establishments in meeting the performance standard, USDA-FSIS developed Appendix A, which provides guidelines for cooking temperatures, times, and relative humidity. This project determined whether the USDA-FSIS performance standards for lethality were met when using parameters other than those identified in Appendix A to cook large hams and beef inside rounds. The effects of alternative lethality parameters on the reduction of Salmonella Typhimurium and coliforms and on the toxin production of Staphylococcus aureus were evaluated. Large (9- to 12-kg) cured bone-in hams (n = 80) and large (8- to 13-kg) uncured beef inside rounds (n = 80) were used in this study. The products were subjected to 1 of 10 treatments defined by combinations of final internal product temperatures (48.9, 54.4, 60.0, 65.6, or 71.1°C) and batch oven relative humidities (50 or 90 % ). For all treatments, at least a 6.5-log reduction in Salmonella Typhimurium was achieved. The coliform counts were also substantially reduced for both hams and rounds. Across all treatments for both products, S. aureus toxin production was not detected. The relative humidity did not alter the lethality effectiveness for any of the treatments. The final internal temperatures and relative humidity combinations used in this project achieved the lethality performance standard established by USDA-FSIS for fully cooked, ready-to-eat products. PMID:22004824

  17. Methods for observational post-licensure medical product safety surveillance.

    PubMed

    Nelson, Jennifer C; Cook, Andrea J; Yu, Onchee; Zhao, Shanshan; Jackson, Lisa A; Psaty, Bruce M

    2015-04-01

    Post-licensure medical product safety surveillance is important for detecting adverse events potentially not identified pre-licensure. Historically, post-licensure safety monitoring has been accomplished using passive reporting systems and by conducting formal Phase IV randomized trials or large epidemiological studies, also known as safety surveillance or pharmacovigilance studies. However, crucial gaps in the safety evidence base provided by these approaches have led to high profile product withdrawals and growing public concern about unknown health risks associated with licensed products. To address the limitations of existing surveillance systems and to facilitate more accurate and rapid detection of safety problems, new systems involving active surveillance of large, population-based cohorts using observational health care databases are being developed. In this article, we review common statistical methods that have been employed previously for post-licensure safety monitoring, including data mining and sequential hypothesis testing, and assess which methods may be promising for potential use within this newly proposed prospective observational cohort monitoring framework. We discuss gaps in existing approaches and identify areas where methodological development is needed to improve the success of safety surveillance efforts in this setting.

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

    PubMed

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

    2015-10-01

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

  19. Food safety and products from aquaculture.

    PubMed

    Reilly, A; Käferstein, F

    1998-12-01

    Aquaculture is currently one of the fastest growing food production systems in the world with production increasing at an average rate of 9.6% per year over the past decade. As world fish stocks are reaching the limits of exploitation, we shall rely to a far greater extent on products from aquaculture as food sources of high nutritional value. Approximately 90% of global aquaculture production is based in Asia, where it provides an important source of dietary animal protein of the region and income for millions of small-scale farmers. Commercial aquaculture contributes significantly to the economies of many producing countries, where highly valued species are a major source of foreign. Many different aquaculture systems exist world wide, ranging from small family-sized fish ponds to intensive cage culture industries as used in salmon fishing. There has been an expansion in the use of integrated farming systems, especially in Asia, where animal and human faeces are used to fertilise ponds. This paper will review global aquaculture systems used in the production of finfish and crustaceans and will focus on potential hazards arising from biological contamination of products that pose risks to public health.

  20. 33 CFR 147.847 - Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Production, Storage, and Offloading System Safety Zone. 147.847 Section 147.847 Navigation and Navigable... ZONES § 147.847 Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone. (a) Description. The BW PIONEER, a Floating Production, Storage and Offloading (FPSO) system, is...

  1. 33 CFR 147.847 - Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Production, Storage, and Offloading System Safety Zone. 147.847 Section 147.847 Navigation and Navigable... ZONES § 147.847 Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone. (a) Description. The BW PIONEER, a Floating Production, Storage and Offloading (FPSO) system, is...

  2. 33 CFR 147.847 - Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Production, Storage, and Offloading System Safety Zone. 147.847 Section 147.847 Navigation and Navigable... ZONES § 147.847 Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone. (a) Description. The BW PIONEER, a Floating Production, Storage and Offloading (FPSO) system, is...

  3. 33 CFR 147.847 - Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Production, Storage, and Offloading System Safety Zone. 147.847 Section 147.847 Navigation and Navigable... ZONES § 147.847 Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone. (a) Description. The BW PIONEER, a Floating Production, Storage and Offloading (FPSO) system, is...

  4. 33 CFR 147.847 - Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Production, Storage, and Offloading System Safety Zone. 147.847 Section 147.847 Navigation and Navigable... ZONES § 147.847 Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone. (a) Description. The BW PIONEER, a Floating Production, Storage and Offloading (FPSO) system, is...

  5. Safety assessment of food products from r-DNA animals.

    PubMed

    Lema, Martin A; Burachik, Moises

    2009-03-01

    Recombinant-DNA (transgenic) animals intended for food production are approaching the market. Among them, recombinant-DNA fishes constitute the most advanced case. As a result, intergovernmental organizations are working on guidelines which would eventually become international standards for national food safety assessments of these products. This article reviews the emerging elements for the food safety assessment of products derived from recombinant-DNA animals. These elements will become highly relevant both for researchers and regulators interested in developing or analyzing recombinant-DNA animals intended to be used in the commercial elaboration of food products. It also provides references to science-based tools that can be used to support food safety assessments. Finally, it proposes recommendations for the further development of biosafety assessment methodologies in this area.

  6. 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...

  7. 30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... safety standards. 6.20 Section 6.20 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as...

  8. 30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... safety standards. 6.20 Section 6.20 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as...

  9. 30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... safety standards. 6.20 Section 6.20 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as...

  10. 77 FR 22602 - Information Collection Activities: Well Control and Production Safety Training, Submitted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-16

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

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as equivalent... intent to review any non-MSHA product safety standard for equivalency in the Federal Register for...

  12. Marketing a managed care plan: achieving product differentiation.

    PubMed

    Romeo, N C

    1996-01-01

    The health care marketplace is changing dramatically, even without federal reform measures. This is a volatile, yet promising, time to market a managed care plan. Before marketing the product, it is critical that the competition is thoroughly evaluated and consumer and employer needs are researched. The final product should be distinguishable from the competition and address market needs. Promotion can then begin, utilizing a proactive public relations and advertising campaign in addition to traditional methods of marketing.

  13. 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...

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

    PubMed

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

    2003-01-01

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

  15. [Important aspects of virus safety of advanced therapy medicinal products].

    PubMed

    Blümel, J; Stühler, A

    2010-01-01

    Virus safety of advanced therapy medicinal products is a particular challenge. These products may consist of whole cells and the manufacture of these is performed using various human or animal-derived starting materials and reagents. Therefore, extensive testing of donors and of established cell banks is required. Furthermore, the virus safety of reagents such as bovine sera, porcine trypsin, and growth factors needs to be considered. Whenever possible, manufacturing steps for inactivation or removal of viruses should be introduced. However, it is not possible to introduce such steps for cell-based medicinal products as the activity and viability of cells will be compromised. Only in the production of small and stable non-enveloped viral gene vectors is it conceivable to implement steps to selectively inactivate or remove potential contaminating enveloped viruses.

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

    ERIC Educational Resources Information Center

    National Business Council for Consumer Affairs, Washington, DC.

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

  17. 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…

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

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 4 2014-10-01 2014-10-01 false Product Safety Plan (PSP). 236.907 Section 236.907 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RULES, STANDARDS, AND INSTRUCTIONS GOVERNING THE INSTALLATION, INSPECTION, MAINTENANCE, AND REPAIR OF SIGNAL...

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

    ERIC Educational Resources Information Center

    Procter and Gamble Educational Services, Cincinnati, OH.

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

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

    ERIC Educational Resources Information Center

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

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

  1. 78 FR 51064 - Safety Zone; Motion Picture Production; Chicago, IL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-20

    ..., 2013 the Coast Guard anticipates that a motion picture corporation will film scenes for a motion... motion picture corporation is expected to film the length of the main Branch of the Chicago River using a... SECURITY Coast Guard 33 CFR Part 165 RIN 1625-AA00 Safety Zone; Motion Picture Production; Chicago,...

  2. 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…

  3. 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…

  4. SAW with multiple electrodes achieves high production rates

    SciTech Connect

    Tusek, J.

    1996-08-01

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

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

    PubMed

    Acerenza, Luis; Monzon, Pablo; Ortega, Fernando

    2015-01-01

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

  6. 42 CFR 3.210 - Required disclosure of patient safety work product to the Secretary.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  7. 42 CFR 3.210 - Required disclosure of patient safety work product to the Secretary.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  8. 42 CFR 3.210 - Required disclosure of patient safety work product to the Secretary.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  9. 42 CFR 3.210 - Required disclosure of patient safety work product to the Secretary.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  10. 42 CFR 3.210 - Required disclosure of patient safety work product to the Secretary.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  11. [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.

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

    PubMed

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

    2015-11-01

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

  13. 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

  14. Efficacy and safety of pomegranate medicinal products for cancer.

    PubMed

    Vlachojannis, Christian; Zimmermann, Benno F; Chrubasik-Hausmann, Sigrun

    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

  15. Carotenoid production in Bacillus subtilis achieved by metabolic engineering.

    PubMed

    Yoshida, Kazuyuki; Ueda, Shunsaku; Maeda, Isamu

    2009-11-01

    The carotenoid synthetic genes, crtM and crtN, derived from Staphylococcus aureus, were introduced into B. subtilis, resulting in yellow pigmentation. Absorption maxima of pigments and MALDI-TOF mass spectrometry demonstrated that the pigmented strain accumulated two C(30) carotenoids, 4,4'-diapolycopene and 4,4'-diaponeurosporene. A survival test using H(2)O(2) revealed that the pigmented strain was more resistant to oxidative stress than the strain harboring an empty-vector. These findings indicate that B. subtilis can produce carotenoids, and the strain accumulating the carotenoids, CarotenoBacillus, will become a basal host for production of C(30) carotenoids and evaluation of their antioxidative effects.

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

    PubMed

    Choi, Seul Min; Lee, Byung-Mu

    2015-10-01

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

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

    PubMed

    Choi, Seul Min; Lee, Byung-Mu

    2015-10-01

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

  18. Executing effective road safety advertising: are big production budgets necessary?

    PubMed

    Donovan, R J; Jalleh, G; Henley, N

    1999-05-01

    Twelve (12) road safety television commercials (TVCs) ranging in production costs from $A15,000 to $A250,000 (current prices) were evaluated using standard advertising pre-test procedures. The twelve ads covered four road safety behaviours (speeding; drink driving; fatigue; and inattention), and included a variety of executional types within and across behaviours. One ad in each of the four behaviours was an expensive TAC and ($A200,000 or more). The testing procedure assessed respondents' self-reported impact of the ad on their future intentions to comply with the road safety behavior advocated in the ad. Just under 1000 appropriately screened motor vehicle drivers license holders were recruited via street intercept methods and randomly allocated to one of the twelve and exposure conditions. The results showed that while the two best performing ads were highly dramatic TAC ads showing graphic crash scenes, these were also the most expensive ads to produce, and, being 60 and 90 s, the most expensive to air. In several cases, 30 s low cost talking heads testimonials performed equally as well as their far more expensive counterparts. We conclude that big production budgets may not be necessary to create effective road safety advertising.

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

    ERIC Educational Resources Information Center

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

    2012-01-01

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

  20. Human safety and efficacy of ultraviolet filters and sunscreen products.

    PubMed

    Nash, J F

    2006-01-01

    Ultraviolet (UV) filters are the active ingredients in sunscreens. The concentration and combination of UV filters determine the efficacy of sunscreens as measured by sun protection factor. The safety of individual UV filters, and, more generally, sunscreen products, is a matter of a few related components: objective toxicologic evaluation, phototoxicologic potential, and human health consequences of using products that may reduce some but not all of the solar UV. Of 16 UV filters approved by the US Food and Drug Administration, 9 are used in different combinations in the most currently marketed sunscreens. Most of these compounds are considered safe and effective alone or in combination with other UV filters based on extensive toxicologic/phototoxicologic evaluations and market history. The benefits from proper use of sunscreens outweigh real or perceived human health concerns, establishing a favorable benefit-to-risk ratio. Future UV filters will require complete human safety evaluations alone and in combination with select benchmark ingredients.

  1. Efficacy and food safety considerations of poultry competitive exclusion products.

    PubMed

    Wagner, Robert Doug

    2006-11-01

    Competitive exclusion (CE) products are anaerobic cultures of bacteria that are applied to poultry hatchlings to establish a protective enteric microbiota that excludes intestinal colonization by human food-borne pathogens. For safety of the poultry flock and human consumers, the identities of bacteria in CE products need to be known. A CE product is a culture of intestinal contents from adult chickens. It may be microbiologically defined by analysis of bacteria isolated from the culture, but many bacteria are hard to reliably isolate, identify, and characterize with conventional techniques. Sequence analysis of 16S ribosomal RNA (rRNA) genes may be more reliable than conventional techniques to identify CE bacteria. Bacteria in CE products may contain antimicrobial drug resistance and virulence mechanisms that could be transferred to the enteric bacteria of the food animal and to the human consumer. Detection methods for specific antimicrobial drug resistance and virulence genes and the integrase genes of conjugative transposons, mostly utilizing PCR technology, are being developed that can be applied to assess these risks in CE bacteria. With improvements in efficacy, bacterial identification, and detection and control of the possible risks of gene transfer, CE product technology can be made a more effective food safety tool.

  2. 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.

  3. Safety of botanical ingredients in personal care products/cosmetics.

    PubMed

    Antignac, Eric; Nohynek, Gerhard J; Re, Thomas; Clouzeau, Jacques; Toutain, Hervé

    2011-02-01

    The key issue of the safety assessment of botanical ingredients in personal care products (PCP) is the phytochemical characterisation of the plant source, data on contamination, adulteration and hazardous residues. The comparative approach used in the safety assessment of GM-plants may be applied to novel botanical PCP ingredients. Comparator(s) are the parent plant or varieties of the same species. Chemical grouping includes definition of chemical groups suitable for a read-across approach; it allows the estimation of toxicological endpoints on the basis of data from related substances (congeneric groups) with physical/chemical properties producing similar toxicities. The Threshold of Toxicological Concern (TTC) and Dermal Sensitisation Threshold (DST) are tools for the assessment of trace substances or minor ingredients. The evaluation of skin penetration of substances present in human food is unnecessary, whereas mixtures may be assessed on the basis of physical/chemical properties of individual substances. Adverse dermal effects of botanicals include irritation, sensitisation, phototoxicity and immediate-type allergy. The experience from dietary supplements or herbal medicines showed that being natural is not equivalent to being safe. Pragmatic approaches for quality and safety standards of botanical ingredients are needed; consumer safety should be the first objective of conventional and botanical PCP ingredients.

  4. 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...

  5. 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

    2014-07-01

    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.

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  12. 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...

  13. Achieving Safety: Safer Sex, Communication, and Desire among Young Gay Men

    PubMed Central

    Eisenberg, Anna; Bauermeister, José; Johns, Michelle Marie; Pingel, Emily; Santana, Matthew Leslie

    2011-01-01

    Conceptualizations of safer sex practices among young gay men (YGM) are frequently structured around communication between partners and the subsequent utilization or absence of condoms in a sexual encounter. Drawing on a sample of 34 in-depth interviews with YGM, ages 18 to 24, we explore the ways in which conceptualizations and definitions of safer sex are discussed and enacted. Placing attention on their safer sex practices, we analyze the conversations that do and do not occur among YGM and their partners, including the strategies (e.g., negotiated safety, condom communication and negotiation) that are commonly perceived as most useful by YGM. We provide recommendations regarding how to craft safer sex messages for YGM by considering their competing demands. PMID:21894239

  14. Achieving Safety: Safer Sex, Communication, and Desire among Young Gay Men.

    PubMed

    Eisenberg, Anna; Bauermeister, José; Johns, Michelle Marie; Pingel, Emily; Santana, Matthew Leslie

    2011-09-01

    Conceptualizations of safer sex practices among young gay men (YGM) are frequently structured around communication between partners and the subsequent utilization or absence of condoms in a sexual encounter. Drawing on a sample of 34 in-depth interviews with YGM, ages 18 to 24, we explore the ways in which conceptualizations and definitions of safer sex are discussed and enacted. Placing attention on their safer sex practices, we analyze the conversations that do and do not occur among YGM and their partners, including the strategies (e.g., negotiated safety, condom communication and negotiation) that are commonly perceived as most useful by YGM. We provide recommendations regarding how to craft safer sex messages for YGM by considering their competing demands. PMID:21894239

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

    ERIC Educational Resources Information Center

    Francis, Becky; Skelton, Christine; Read, Barbara

    2010-01-01

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

  16. 42 CFR 3.212 - Nonidentification of patient safety work product.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  18. 42 CFR 3.212 - Nonidentification of patient safety work product.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  19. 42 CFR 3.212 - Nonidentification of patient safety work product.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  20. 42 CFR 3.212 - Nonidentification of patient safety work product.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  1. 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.

  2. 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).

  3. Impact of sedating antihistamines on safety and productivity.

    PubMed

    Kay, G G; Quig, M E

    2001-01-01

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

  4. Consideration of the production methods and safety evaluation of cytokines.

    PubMed

    Liu, D T

    1988-01-01

    Cytokines are natural endogenous substances whose biological effects in humans are little known when given in therapeutic rather than physiologic doses. Yet, there is intense interest in seeking their possible clinical use. While E. coli are effective in making "simple proteins" with few disulfide bonds, mammalian cells are becoming more generally used for the production of "complex proteins" with multiple disulfide bonds and glycoproteins. There appears to be much less concern about the safety of possibly oncogenic residual DNA from transformed cell lines, but viral contamination of products continues to be an active concern. Both physicochemical and biological methods are necessary to establish the identity, purity and potency of biological drugs. For proteins to manifest their proper biological and therapeutic effects in humans, their correct conformation must be maintained throughout production, purification and formulation. Regulating novel biological drugs such as the cytokines might raise new scientific issues that are not currently apparent, but the basic principles involved will be consistent with those used to evaluate other biologics, e.g., sound scientific principles, flexibility, case-by-case approach, good common sense and risk vs benefit assessment.

  5. 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.

  6. 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)

  7. 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.

  8. Safety and Feasibility of Achieving Lower Systolic Blood Pressure Goals in Persons With Type 2 Diabetes: The SANDS Trial

    PubMed Central

    Weir, Matthew R.; Yeh, Fawn; Silverman, Angela; Devereux, Richard B.; Galloway, James M.; Henderson, Jeffrey A.; Howard, William J.; Russell, Marie; Wilson, Charlton; Ratner, Robert; Sorkin, John; Umans, Jason; Fleg, Jerome L.; Stylianou, Mario; Lee, Elisa; Howard, Barbara V.

    2009-01-01

    The Stop Atherosclerosis in Native Diabetics Study (SANDS) was a randomized open-label clinical trial in type 2 diabetics designed to examine the effects of intensive reduction of blood pressure, aggressive vs standard goals (≤115 / 75 mm Hg vs ≤130 / 80 mm Hg), and low-density lipoprotein (LDL) cholesterol on the composite outcome of change in carotid intimal-medial thickness and cardiovascular events. The study demonstrated that in conjunction with a lower LDL cholesterol target of 70 mg/ dL, aggressive systolic blood pressure–lowering resulted in a reduction in carotid intimal-medial thickness and left ventricular mass without measurable differences in cardiovascular events. The blood pressure treatment algorithm included renin-angiotensin system blockade, with other agents added if necessary. The authors conclude that both standard and more aggressive systolic blood pressure reduction can be achieved with excellent safety and good tolerability in patients with type 2 diabetes mellitus. PMID:19817934

  9. 30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false MSHA acceptance of equivalent non-MSHA product safety standards. 6.20 Section 6.20 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING AND EVALUATION BY INDEPENDENT LABORATORIES AND NON-MSHA PRODUCT...

  10. 77 FR 58567 - Information Collection Activities: Well Control and Production Safety Training, Submitted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-21

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

  11. 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.

  12. Microbial performance of food safety management systems implemented in the lamb production chain.

    PubMed

    Osés, S M; Luning, P A; Jacxsens, L; Santillana, S; Jaime, I; Rovira, J

    2012-01-01

    The actual microbial status of the lamb production chain at three slaughterhouses, one processing plant, and five butcher shops selling whole or cut lamb carcasses to consumers was assessed with a previously developed microbial assessment scheme. All studied establishments had a food safety management system (FSMS) that was implemented according to legislative requirements. Microbial safety level profiles were constructed for each establishment and provided clear indications of which pathogens, hygiene indicators, or utility parameters required attention to improve the performance of the microbiological control protocols of the implemented FSMS. The highest contamination was found in the slaughterhouses in samples taken from the meat products (aerobic mesophilic plate counts [AMPs] of 3.40 to 6.63 log CFU/cm(2) and Enterobacteriaceae counts of 1.00 to 4.62 log CFU/cm(2)), contact surfaces (AMPs of 2.44 to 8.92 log CFU/cm(2)), and operators' hands and/or gloves (AMPs of 2.84 to 8.09 log CFU/cm(2)), especially after hide removal and evisceration. The microbial assessment scheme is a useful tool for providing insight into the actual microbiological results achieved with an FSMS implemented in establishments at various stages along the lamb production chain.

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

    PubMed

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

    2016-02-29

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

  14. Quality and safety of bovine clones and their products.

    PubMed

    Heyman, Y; Chavatte-Palmer, P; Fromentin, G; Berthelot, V; Jurie, C; Bas, P; Dubarry, M; Mialot, J P; Remy, D; Richard, C; Martignat, L; Vignon, X; Renard, J P

    2007-08-01

    cattle derived from somatic nuclear transfer than in cattle born from conventional reproduction. Our results confirm that the quality and safety of products (milk and meat) from adult and clinically healthy cloned cattle is globally similar to normal animals. However, from a strictly biological point of view, the slightly delayed maturation we observed in the muscle of clones together with some marginal differences identified in FA composition of both muscle and milk, point to the need for more refined analysis to totally exclude any risks from the consumption of those products.

  15. 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…

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

    ERIC Educational Resources Information Center

    Phelps, James L.

    2011-01-01

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

  17. 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…

  18. Exploring Informal Mathematical Products of Low Achievers at the Secondary School Level

    ERIC Educational Resources Information Center

    Karsenty, Ronnie; Arcavi, Abraham; Hadas, Nurit

    2007-01-01

    This article examines the notion of informal mathematical products, in the specific context of teaching mathematics to low achieving students at the secondary school level. The complex and relative nature of this notion is illustrated and some of its characteristics are suggested. These include the use of ad-hoc strategies, mental calculations,…

  19. On the Specification and Estimation of the Production Function for Cognitive Achievement.

    ERIC Educational Resources Information Center

    Todd, Petra E.; Wolpin, Kenneth I.

    2003-01-01

    Examines ways to model the production function for cognitive achievement to capture theoretical notions that child development is a cumulative process involving family and school inputs and ability. Develops a modeling framework that accommodates several known estimating equations, discussing how to address data limitations and highlighting the…

  20. Safety Observations Achieve Results

    2000-01-16

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

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

    PubMed

    Xiao, Ming; Dong, Nan; Lyu, Xin

    2015-08-01

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

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

    PubMed

    Xiao, Ming; Dong, Nan; Lyu, Xin

    2015-08-01

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

  3. Radiation safety aspects of production of commercial levels of medical radioisotopes

    NASA Astrophysics Data System (ADS)

    Boothe, T. E.; McLeod, T. F.; Fernandez-Rubio, F.

    1993-06-01

    The first step toward efficient radiation safety in a facility that intends to produce commercial levels of radionuclides is to nticipate the scope of the facility during the design stages of the physical plant and during formulation of operating procedures. The design and operation must include flexibility to accommodate changing needs of production and research and development while providing radiation safety. A recently proposed licensing guide from the Bureau of Radiation Control, Texas Department of Health, while providing for safe operation, would severely limit flexibility and development. For example, engineering controls and procedures should be specified for generic systems as opposed to each specific radionuclide and by-products. Operator training is critical for reduced exposure and should be addressed, but requiring prior training for all operators is not reasonably achievable and would result in loss of proprietary information. Procedures to reduce exposure should include experimentally determined "cooldown" times, "problem indexes" for specific jobs related to particular cyclotrons, and proper management and administrative structures.

  4. 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

    ... using a systems approach to minimize medication errors relating to product design. The draft guidance... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Safety Considerations for... guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication...

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

    ERIC Educational Resources Information Center

    Lacina, Dale Robert

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

  6. 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...

  7. 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.

  8. Product safety in Great Britain and the Consumer Protection Act 1987.

    PubMed

    Jenkins, D W; Davies, B T

    1989-09-01

    The Consumer Protection Act 1987 imposes new demands on manufacturers regarding the safety of their products. They can be sued directly by any person injured by their defective goods and prosecuted if they fail to meet the new comprehensive general safety requirement and any other safety provision. Product designers and ergonomists need a sound understanding of and involvement in the legal aspects of product safety. It is now essential to take into account what may reasonably be done with goods, or foreseeable conditions of use, in order to satisfy the test of what is "reasonably safe" and meet the level of safety which "persons generally are entitled to expect" under the law. Any significant progress in product safety will now come through developments in technical standards which will be harmonised throughout the European Community. It is essential that ergonomics considerations be taken into account during the drafting of product specifications if users' interests are to be safeguarded more effectively. Ergonomists will be required to make an even greater contribution in the field of product safety, therefore, by assisting in the determination of the new statutory safety criteria. They are uniquely qualified to ensure that the product user is fully considered at the design and assessment stages which can now be looked upon as an essential pre-requisite of the law and not just sound engineering policy. PMID:15676737

  9. How to achieve synergy between volume replacement and filling products for global facial rejuvenation.

    PubMed

    Raspaldo, Hervé; Aziza, Richard; Belhaouari, Lakhdar; Berros, Philippe; Body, Sylvie; Galatoire, Olivier; Le Louarn, Claude; Michaud, Thierry; Niforos, François; Rousseaux, Isabelle; Runge, Marc; Taieb, Maryna

    2011-04-01

    The objective of this paper is to provide an expert consensus regarding facial rejuvenation using a combination of volume replacement (Juvéderm(®) VOLUMA(®)), filling products (Juvéderm(®) Ultra product line) and botulinum toxin. The Juvéderm product line exploits innovative 3-D technology, producing a range of cohesive, homogenous gels that produce predictable, long-lasting and natural results. The products are easy to use by practitioners and are well-tolerated by patients, and used in combination can provide additional benefits not achieved with one product alone. An assessment of facial anatomy and consideration of the aging process, as well as available treatment options, are also addressed in determining the best combination of products to use. Outcomes from a questionnaire and workshop sessions focusing on specific aspects of use of the Juvéderm product line and botulinum toxin in daily clinical practice are discussed, and recommendations for product use following debate amongst the experts are provided.

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

    SciTech Connect

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

    1996-12-31

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-27

    ... railroad productivity and significantly improving the safety of train operations, roadway workers, and... individual submitting the comment (or signing the document, if submitted on behalf of an association... published on April 11, 2000 (65 FR 19477). Robert C. Lauby, Deputy Associate Administrator for...

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

    ERIC Educational Resources Information Center

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

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

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

    PubMed

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

    1999-09-01

    Three studies were conducted to determine the effect of a role model's safety behavior on observers' safety behavior. In Studies 1 and 2, role models (confederates) used a cleaning product requiring them to wear safety gloves. Study 1 examined observers' safety behavior after they witnessed a friendly (unfriendly) role model's safety behavior in one of four conditions: 1) wearing rubber gloves, 2) not wearing rubber gloves and experiencing no chemical burn, 3) not wearing rubber gloves and experiencing a mild chemical burn, and 4) not wearing rubber gloves and experiencing a severe chemical burn. In Study 2, participants tested a cleaning product with a warning message (low hazard vs. high hazard) after observing a role model first test the cleaning product in one of the four conditions specified above. As predicted, in Studies 1 and 2, observers were influenced by the role model's safety behavior. However, the friendliness of the role model (Study 1) and level of hazard (Study 2) communicated in the warning message did not influence participants' safety behavior. Using an over-the-counter pain reliever, Study 3 tested the joint effects of: 1) the level of hazard communicated in the warning, 2) observers' outcome-relevant involvement, and 3) role model's compliance. Although the level of hazard communicated in the warning exerted no impact on observers' safety compliance, the role model's safety behavior and level of involvement jointly influenced observers' safety behavior. The implications of the findings and future research directions are discussed. Actual or potential applications of the research include, but are not limited to, using role models in warning messages and safety training programs to demonstrate the proper use of safety gear so as to enhance product users' compliance with safety recommendations. PMID:10665208

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

    SciTech Connect

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

    1986-05-01

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

  15. 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.

  16. 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

  17. 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

  18. 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…

  19. 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.

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

    NASA Astrophysics Data System (ADS)

    Lu, Renfu; Chen, Yud-Ren

    1999-01-01

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

  1. 42 CFR 3.206 - Confidentiality of patient safety work product.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... patient safety work product for use in a criminal proceeding, but only after a court makes an in-camera...; (3) Telephone numbers; (4) Fax numbers; (5) Electronic mail addresses; (6) Social security numbers or... at 45 CFR 164.514(e)(2) have been removed. (5) Disclosure of nonidentifiable patient safety...

  2. Consumer Product Safety: What's It All About? Teacher's Guide. No. 8-T.

    ERIC Educational Resources Information Center

    Consumer Product Safety Commission, Washington, DC.

    Designed as a flexible resource, this material may be used independently or in conjunction with existing safety, health, consumer education, economics, or social studies units. To facilitate the incorporation of product safety information into the curriculum, the suggested activities section lists major concepts to be developed and indicates…

  3. 77 FR 10358 - Acceptance of ASTM F963-11 as a Mandatory Consumer Product Safety Standard

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Chapter II Acceptance of ASTM F963-11 as a Mandatory Consumer Product Safety Standard AGENCY: Consumer Product Safety Commission. ACTION: Acceptance of standard. SUMMARY: The Consumer...

  4. 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

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

    ERIC Educational Resources Information Center

    Smith, Herb

    1990-01-01

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

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

    PubMed

    Dzingirayi, Garikayi; Korsten, Lise

    2016-07-01

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

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

    PubMed

    Dzingirayi, Garikayi; Korsten, Lise

    2016-07-01

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

  8. 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)

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

    PubMed

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

    2015-01-01

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

  10. 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

  11. 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.

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

    PubMed

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

    2015-06-15

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed

    McBlane, James W

    2015-09-01

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

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

    PubMed

    McBlane, James W

    2015-09-01

    The objectives of preclinical testing include to show why there might be therapeutic benefit in patients and to provide information on the product's toxicity. For cell-based products, given even once, there may be long term exposure and this could imply, unlike for conventional drugs, that all preclinical studies may be needed prior to first human use. The duration of exposure to cells should be studied in animals to guide toxicity assessments. Distribution of cells after administration by a route resembling that intended in humans should be studied to understand potential risks. Risk of tumour formation with the product may also need to be characterised. To the extent that this information can be generated by in vitro testing, studies in animals may not be needed and limitations on the capability of preclinical data to predict human toxicity are recognised: species-specificity make some cell products act only in humans and a human cell-product might be expected to be rejected by immunocompetent animals. Does this suggest testing in immunosuppressed animals or of development of an animal-cell product supposedly similar to the human cell product? No single answer seems to fit every situation. PMID:26026578

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

    PubMed

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

    2010-05-01

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

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

    ERIC Educational Resources Information Center

    Fise, Mary Ellen R.

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

  18. 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.

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

    PubMed

    1991-12-01

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

  20. Nutritional selenium supplements: product types, quality, and safety.

    PubMed

    Schrauzer, G N

    2001-02-01

    Selenium supplements contain selenium in different chemical forms. In the majority of supplements, the selenium is present as selenomethionine. However, in multivitamin preparations, infant formulas, protein mixes, weight-loss products and animal feed, sodium selenite and sodium selenate are predominantly used. In some products, selenium is present in protein- or amino acid chelated forms; in still others, the form of selenium is not disclosed. Current evidence favors selenomethionine over the other forms of selenium. Extradietary supplementation of selenium at the dosage of 200 micrograms per day is generally considered safe and adequate for an adult of average weight subsisting on the typical American diet.

  1. 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.

  2. 75 FR 29155 - Publicly Available Consumer Product Safety Information Database

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-24

    ... information from the public through its Internet Web site through forms reporting on product-related injuries.... The proposal would describe four methods (internet, telephone, electronic mail, and paper) for.... 1102.10(b)(1) would explain that submitters using the Internet will use an electronic form...

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., MAINTENANCE, AND REPAIR OF SIGNAL AND TRAIN CONTROL SYSTEMS, DEVICES, AND APPLIANCES Standards for Processor... railroad operation or categories of operations on which the product is designed to be used, including train... comprehensive description of all hazards to be addressed in the system design and development,...

  4. PETRO-SAFE '91 conference papers: Volume 3 (Drilling and production environment and safety), Volume 4 (Transportation and storage environment and safety) and Volume 5 (Processing and refining environment and safety)

    SciTech Connect

    Not Available

    1991-01-01

    This conference provided a forum for the oil, gas, and petrochemical industries to discuss state of the art knowledge in those fields. The following topics were addressed: drilling and production environment and safety; transportation and storage environment and safety; and processing and refining environment and safety. Separate papers are processed for inclusion in the appropriate data bases.

  5. 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.

  6. [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.

  7. 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.

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

    ERIC Educational Resources Information Center

    Rodgers, Gregory B.

    1990-01-01

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

  9. 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.

  10. 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.

  11. On the safety of a new generation of DSM Aspergillus niger enzyme production strains.

    PubMed

    van Dijck, Piet W M; Selten, Gerard C M; Hempenius, Rixta A

    2003-08-01

    Consumers safety of enzyme preparations is determined by three variables: the producing organism, the raw materials used in the production, and the production process itself. The latter one is embedded in current Good Manufacturing Practice (cGMP) and Hazard Analysis of Critical Control Points (HACCP); therefore the safety focus can be directed to raw materials and the producing organism. In this paper, we describe the use of novel genetically modified strains of Aspergillus niger-made by a design and build strategy-from a lineage of classically improved strains with a history of safe use in enzyme production. The specifics of the host strain allow for integration and over-expression of any gene of interest at a targeted integration site implying that the rest of the host genome is not affected by this integration. Furthermore due to the fact that the newly integrated gene copies are put under the genetic regulation of the host's own glucoamylase promoter, the recipe of the production process of any new production strain can be kept constant with respect to the raw materials composition. Consequently the safety of a new enzyme product from these novel genetically modified strains is determined by the background of the production organism. The use of a strain with a history of safe use and targeted integration according to the concept described above has consequences for the safety studies on the final product. If a known enzymatic activity is over-expressed the safety of a new enzyme preparation is covered by the results of the safety studies performed for other strains from this specific Aspergillus niger strain lineage. In this paper an overview is given on the available toxicity tests with these strains. We conclude that for new enzyme products produced with strains from this lineage using the design and build technology no new sub-acute/chronic oral toxicity studies are needed. This also has the benefit that no longer test animals are needed to demonstrate the

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2016-01-01

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

  14. 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.

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

    NASA Astrophysics Data System (ADS)

    Wessels, H.; Stephan, H. J.

    1991-08-01

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

  16. 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.

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

    ERIC Educational Resources Information Center

    Consumer Product Safety Commission, Washington, DC.

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

  18. 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.

  19. 76 FR 9328 - Public Availability of Consumer Product Safety Commission FY 2010 Service Contract Inventory

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-17

    ..., Division of Procurement Services, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda... work location of contractor and subcontractor employees, expressed as full-time equivalents for direct.../sites/default/files/omb/procurement/memo/service-contract-inventories-guidance-11052010.pdf .) The...

  20. 77 FR 8818 - Public Availability of Consumer Product Safety Commission FY 2011 Service Contract Inventory

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

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

  1. 78 FR 33392 - Public Availability of Consumer Product Safety Commission FY 2012 Service Contract Inventory

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-04

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

  2. 76 FR 1137 - Publicly Available Consumer Product Safety Information Database: Notice of Public Web Conferences

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

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

  3. 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...

  4. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... CFR part 1212. This definition includes products that are referred to as micro-torches. Multi-purpose... requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than.... Manufacturers would have to devote some resources to the development or modification of technology to...

  5. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... CFR part 1212. This definition includes products that are referred to as micro-torches. Multi-purpose... requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than... fireplaces, charcoal or gas-fired grills, camp fires, camp stoves, lanterns, or fuel-fired appliances...

  6. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... CFR part 1212. This definition includes products that are referred to as micro-torches. Multi-purpose... requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than... fireplaces, charcoal or gas-fired grills, camp fires, camp stoves, lanterns, or fuel-fired appliances...

  7. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... CFR part 1212. This definition includes products that are referred to as micro-torches. Multi-purpose... requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than... fireplaces, charcoal or gas-fired grills, camp fires, camp stoves, lanterns, or fuel-fired appliances...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-17

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

  10. 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

  11. 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.

  12. 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.

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

    PubMed

    Kawakami, Tsuyoshi

    2011-12-01

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

  14. Drug safety in pregnancy: utopia or achievable prospect? Risk information, risk research and advocacy in Teratology Information Services.

    PubMed

    Schaefer, Christof

    2011-03-01

    Even though from preclinical testing to drug risk labeling, the situation with drugs in pregnancy has improved substantially since the thalidomide scandal, there is still an increasing need to provide healthcare professionals and patients with updated individualized risk information for clinical decision making. For the majority of drugs, clinical experience is still insufficient with respect to their safety in pregnancy. There is often uncertainty in how to interpret the available scientific data. Based on 20 years of experience with Teratology Information Services (TIS) cooperating in the European Network of Teratology Information Services (ENTIS) methods of risk interpretation, follow-up of exposed pregnancies through the consultation process and their evaluation is discussed. Vitamin K antagonists, isotretinoin and angiotensin (AT) II-receptor-antagonists are presented as examples of misinterpretation of drug risks and subjects of research based on observational clinical data recorded in TIS. As many TIS are poorly funded, advocacy is necessary by establishing contacts with decision makers in health politics and administration, informing them of the high return in terms of health outcomes and cost savings provided by TIS as reference institutions in clinical teratology.

  15. 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.

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

    PubMed

    Sohn, Mun-Gi; Oh, Sangsuk

    2014-08-01

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

  17. Efficacy and safety of ezetimibe co-administered with ongoing atorvastatin therapy in achieving low-density lipoprotein goal in patients with hypercholesterolemia and coronary heart disease.

    PubMed

    Cruz-Fernández, J M; Bedarida, G V; Adgey, J; Allen, C; Johnson-Levonas, A O; Massaad, R

    2005-06-01

    This randomised, double-blind, placebo (PBO)-controlled study evaluated the efficacy and safety of ezetimibe (EZE) co-administered with ongoing atorvastatin (ATV) therapy in 450 hypercholesterolemic patients with coronary heart disease (CHD) who had not achieved their low-density lipoprotein cholesterol (LDL-C) goal < or =2.60 mmol/l while on a stable dose of ATV 10 or 20 mg/day for > or =6 weeks. After a 4-week diet/baseline active run-in period, patients with LDL-C >2.60 mmol/l and < or =4.20 mmol/l were stratified by ATV dose and randomised (1 : 1) to EZE 10 mg or PBO for 6 weeks while continuing open-label ATV. Significantly more patients achieved an LDL-C goal < or =2.6 mmol/l with EZE than PBO (81.3 vs. 21.8%; p < or = 0.001). Compared to PBO, co-administration of EZE with ongoing ATV led to significantly (p < or = 0.001) greater reductions in LDL-C, total cholesterol, triglycerides, non-high-density lipoprotein cholesterol (non-HDL-C), and apolipoprotein B; HDL-C was significantly (p < or = 0.05) increased. Co-administration of EZE and ATV was well tolerated, with an overall safety profile similar to ATV alone.

  18. A method to assess safety and resilience in radiopharmaceuticals production process.

    PubMed

    Grecco, Cláudio H S; Vidal, Mario C R; Santos, Isaac J A L; Carvalho, Paulo V R

    2012-01-01

    Radiopharmaceuticals are radiation-emitting substances used in medicine for radiotherapy and imaging diagnosis. A Research Institute, located in Rio de Janeiro, produces three radiopharmaceuticals: the sodium iodate is used in the diagnosis of thyroid dysfunctions, the meta-iodo-benzylguanidine is used in the diagnosis of cardiac diseases, and the fluordesoxyglucose is used in diagnosis in cardiology, oncology, neurology and neuropsychiatry. This paper presents a method to access safety and resilience in radiopharmaceuticals production processes. The method uses resilience indicators in order to proactively evaluate and manage the safety.

  19. 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

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

    PubMed

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

    2012-01-01

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

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

    PubMed

    Martens, T

    1995-03-01

    The diversity and quantities of vacuum packed and vacuum cooked prepared meals and menu components are rapidly growing on the European market. Because of the minimal heat processing, high water activity, absence of preservatives, and the use of many different often exotic ingredients, these products have a high risk potential. For this reason, Anglo-Saxon governments and industries are very sceptical about the safety of "sous vide" products. Industrial practice, as well as parallel tests and recent studies on inoculated packs have shown that, in many cases, it is more a potential than a real risk. Quality is the primary concern for "sous vide" products, and safety must be guaranteed by the application of the Hazard Analysis Critical Control Point (HACCP) concept, along with an adequate combination of different inhibitory factors (temperature of heating and cooling, pH, incorporation of starter cultures, bacteriocins and some particular enzymes). PMID:7546442

  3. Generic substitution: the use of medicinal products containing different salts and implications for safety and efficacy.

    PubMed

    Verbeeck, R K; Kanfer, I; Walker, R B

    2006-05-01

    In their quest to gain early entry of new generic products into the market prior to patent expiration, one of the strategies pursued by generic drug product manufacturers is to incorporate different salts of an approved active pharmaceutical ingredient (API) in a brand company's marketed dosage form and subject such dosage forms to bioequivalence assessment. These initiatives present challenges to regulatory authorities where the decision to approve bioequivalent products containing such pharmaceutical alternatives must be considered in the light of safety and efficacy, and more particularly, with respect to their substitutability. This article describes the various issues and contentions associated with the concept of pharmaceutical alternatives, specifically with respect to the uses of different salts and the implications for safety, efficacy and generic substitution.

  4. 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.

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

    ERIC Educational Resources Information Center

    Rothstein, Jesse

    2008-01-01

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

  6. 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. 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…

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

    PubMed

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

    2012-08-01

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

  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. Safety of Sanguinaria extract as used in commercial toothpaste and oral rinse products.

    PubMed

    Frankos, V H; Brusick, D J; Johnson, E M; Maibach, H I; Munro, I; Squire, R A; Weil, C S

    1990-01-01

    This report represents the findings of an Expert Panel on the safety of Sanguinaria extract used in Viadent oral rinse and toothpaste products and represents an independent review of the Sanguinaria extract toxicologic data base. It is based on reviews and discussions of the data base by all members of the Expert Panel on Sanguinaria extract. The Panel concluded that the data base on Sanguinaria extract is substantial and indicates that Sanguinaria extract is safe in its present use in Viadent products based on a large margin of safety between levels of human exposure and levels found to produce minimum effect or to be without adverse effect in animals. The panel further concluded that published literature suggesting an association between human exposure to Sanguinaria extract and potential reproductive, cardiovascular, or ocular toxicity, or carcinogenicity is largely anecdotal, unfounded, and not corroborated by or consistent with the substantial data base that was subjected to peer review.

  11. 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

  12. 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.

  13. 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.

  14. Effects of genetic, processing, or product formulation changes on efficacy and safety of probiotics.

    PubMed

    Sanders, Mary Ellen; Klaenhammer, Todd R; Ouwehand, Arthur C; Pot, Bruno; Johansen, Eric; Heimbach, James T; Marco, Maria L; Tennilä, Julia; Ross, R Paul; Franz, Charles; Pagé, Nicolas; Pridmore, R David; Leyer, Greg; Salminen, Seppo; Charbonneau, Duane; Call, Emma; Lenoir-Wijnkoop, Irene

    2014-02-01

    Commercial probiotic strains for food or supplement use can be altered in different ways for a variety of purposes. Production conditions for the strain or final product may be changed to address probiotic yield, functionality, or stability. Final food products may be modified to improve flavor and other sensory properties, provide new product formats, or respond to market opportunities. Such changes can alter the expression of physiological traits owing to the live nature of probiotics. In addition, genetic approaches may be used to improve strain attributes. This review explores whether genetic or phenotypic changes, by accident or design, might affect the efficacy or safety of commercial probiotics. We highlight key issues important to determining the need to re-confirm efficacy or safety after strain improvement, process optimization, or product formulation changes. Research pinpointing the mechanisms of action for probiotic function and the development of assays to measure them are greatly needed to better understand if such changes have a substantive impact on probiotic efficacy.

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

    SciTech Connect

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

    2010-03-01

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

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

    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

  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.

    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

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

    PubMed

    Wang, Ying; Tashiro, Yukihiro; Sonomoto, Kenji

    2015-01-01

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

  20. 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 ...

  1. 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....

  2. 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.

  3. [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.

  4. 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.; Maki, John T.

    2016-04-07

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

  5. 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

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

    SciTech Connect

    D. SIEBE; K. PASAMEHMETOGLU

    2000-11-01

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

  7. SRF Accelerator Technology Transfer Experience from the Achievement of the SNS Cryomodule Production Run

    SciTech Connect

    John Hogan; Ed Daly; Michael Drury; John Fischer; Tommy Hiatt; Peter Kneisel; John Mammosser; Joseph Preble; Timothy Whitlatch; Katherine Wilson; Mark Wiseman

    2005-05-01

    This paper will discuss the technology transfer aspect of superconducting RF expertise, as it pertains to cryomodule production, beginning with the original design requirements through testing and concluding with product delivery to the end user. The success of future industrialization, of accelerator systems, is dependent upon a focused effort on accelerator technology transfer. Over the past twenty years the Thomas Jefferson National Accelerator Facility (Jefferson Lab) has worked with industry to successfully design, manufacture, test and commission more superconducting RF cryomodules than any other entity in the world. The most recent accomplishment of Jefferson Lab has been the successful production of twenty-four cryomodules designed for the Spallation Neutron Source (SNS). Jefferson Lab was chosen, by the United States Department of Energy, to provide the superconducting portion of the SNS linac due to its reputation as a primary resource for SRF expertise. The successful partnering with, and development of, industrial resources to support the fabrication of the superconducting RF cryomodules for SNS by Jefferson Lab will be the focus of this paper.

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

    PubMed

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

    2010-01-01

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

  9. 75 FR 47602 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Clinical Studies of Safety and Effectiveness of Orphan... program is to support the clinical development of products for use in rare diseases or conditions where no... provides grants for clinical studies on safety and/or effectiveness that will either result in,...

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

    PubMed

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

    2016-07-01

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

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

    PubMed

    Fleet, Graham H

    2007-04-01

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

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

    PubMed

    Fleet, Graham H

    2007-04-01

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

  13. High-throughput proteomics: a new tool for quality and safety in fishery products.

    PubMed

    Tedesco, Sara; Mullen, William; Cristobal, Susana

    2014-03-01

    In order to cope with the increasing demand for fishery products, sensitive technological tools are required to ensure high quality and wholesomeness and to monitor their production process in a sustainable manner while complying with the strict standards imposed by regulatory authorities. Proteomics may assist the industry as it allows an unbiased approach in the discovery of biomarkers that could be used to increase our understanding of different biological, physiological and ecological aspects that may be advantageous in optimizing quality and safety in aquatic species. The aim of this review is to highlight the potential of cost-effective high-throughput technologies, such as those offered by proteomics using "on-line" mass spectrometry to improve the efficiency of the industry in identifying biomarkers relevant for safe high quality products.

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

    PubMed

    Jenke, Dennis

    2007-10-01

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

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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

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

    PubMed Central

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

    2015-01-01

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

  2. 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.

  3. Ergonomics strategies and actions for achieving productive use of an ageing work-force.

    PubMed

    Kumashiro, M

    2000-07-01

    In this report, a basic ERGOMA (Ergonomics in Industrial Management) strategy is proposed as a policy for corporate production and employment in countries where ageing populations and reduced birth rates are imminent, and a strategy related to this is proposed. Specifically, as a strategy at the company level, the results of survey studies aimed at the development of methods for determining job capacity, to enable effective use of the labour of ageing workers, were summarized. A number of the insights gained here are steps in the development of a foundational methodology for practical use, and in actual practice a number of these insights must be subjected to measurements. However, the theory and newly developed methodology described here are thought to represent significant changes from the approaches to job capacity diagnosis and assessment published in the past and from the stance towards utilization of an ageing work-force. The author is confident that this represents new progress in one of the ergonomics approach to dealing with the working environment of ageing workers and an ageing work-force in general. PMID:10929834

  4. 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.

  5. 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.

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

    DOE PAGES

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

    2014-11-01

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

  7. 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.

  8. 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.

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

    PubMed

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

    2009-12-01

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

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

    PubMed Central

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

    2012-01-01

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

  11. Empowering consumers as contributors for health product safety: lessons from the Philippines.

    PubMed

    Hartigan-Go, Kenneth

    2015-04-01

    Empowering consumers to contribute to adverse drug reaction reporting seems a sensible innovation, particularly when traditional reports emanating from healthcare professionals are neither increasing nor improving. This work, inspired by an EU-FP7-funded project, describes an attempt by the Philippines to introduce a consumer reporting system through education and an online platform for reporting, and the lessons that were captured in the process. While participating consumers did not contribute to the adverse drug reporting process in the traditional sense as originally expected, the reports received by the drug regulatory agency revealed consumers' concerns regarding health product legitimacy, quality and market claims, as well as the lack of available and accessible information. These reports led regulators to take action. Initial insights on consumer behavior are proposed for regulators and industry to consider in greater depth and how this may impact on consumers providing valued information that will promote other aspects of product safety.

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

    PubMed

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

    2006-05-20

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

  13. 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

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

    PubMed

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

    2013-01-01

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

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

    PubMed

    Ahlawat, Kulveer Singh; Khatkar, Bhupender Singh

    2011-10-01

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

  17. How can the safety of biotherapy products be ensured for patients?

    PubMed

    Brailly, Hervé; Postaire, Eric; Zorzi, Pierrette

    2004-01-01

    The topic of the round table being very broad, it was agreed with the participants that the discussion should be focused on autologous cell therapy (CT) used in tissue repair, immunomodulation or gene transduction. Autologous CT is actually comprised of both very innovative procedures as well as of products used in routine clinical practice. In France, the regulatory framework for CT has now been finalised, underlining the fact that a CT product (CTP) is intrinsically linked to the process used in its preparation. The objective of this round table was to define the essential prerequisites for the development of therapies involving ex vivo cell preparations and, more specifically, to address the issues associated with patient safety during the course of product development. The different stages of CTP development were considered: (i) requirements for CTP manufacturing in order to guarantee product quality; (ii) nonclinical development, and selection of appropriate animal models to provide the proof of the concept and support the definition of CTP specifications; and (iii) clinical development and methodological specificities of CTP development. The specific problems associated with the use of ancillary therapeutic products (ATPs) during the development of a CTP were discussed. Actions were proposed to ensure long-term supply of ATPs, which may be a significant bottleneck for the development of CT in France. Eventually, new regulatory provisions will come into force in the area of biovigilance, and it was deemed necessary for healthcare and industry professionals to be appropriately involved in the implementation phase.

  18. 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

  19. 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.

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

    PubMed

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

    2016-07-01

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

  1. 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

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

    PubMed

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

    2015-11-01

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

  3. 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.

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

    PubMed

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

    2015-11-01

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

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

    PubMed

    Harlander, Susan K

    2002-01-01

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

  6. 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

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

    PubMed

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

    2013-02-01

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

  8. 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

  9. 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.

  10. [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.

  11. 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.

  12. Safety of human blood products: inactivation of retroviruses by heat treatment at 60 degrees C.

    PubMed

    Hilfenhaus, J; Mauler, R; Friis, R; Bauer, H

    1985-04-01

    Acquired immune deficiency syndrome (AIDS) can be transferred to patients by blood transfusions or human blood preparations, such as cryoprecipitates or factor VIII concentrates. Retroviruses have been discussed as infectious AIDS agents and more recently human T-lymphotropic retroviruses designated as HTLV type III and LAV (lymphadenopathy-associated virus) have been isolated from AIDS patients. Whether heat treatment at 60 degrees C (pasteurization) of liquid human plasma protein preparations inactivates retroviruses was therefore investigated. Pasteurization had already been included in the routine manufacturing process of human plasma protein preparations in order to guarantee safety with regard to hepatitis B. Since high titer preparations of human retroviruses were not available, heat inactivation was studied using Rous sarcoma virus added to the various plasma protein preparations tested. This retrovirus which was obtained in preparations of 6.0 log10 FFU/ml was shown to be at least as heat stable as two mammalian retroviruses studied, i.e., feline and simian sarcoma virus. In all of eight different plasma protein preparations tested, Rous sarcoma virus was completely inactivated after a heat treatment lasting no longer than 4 hr. It is thus concluded that pasteurization of liquid plasma protein preparations at 60 degrees C over a period of 10 hr must confer safety to these products with respect to AIDS, provided that the AIDS agents are retroviruses of comparable heat stability as Rous sarcoma virus and the mammalian retroviruses tested.

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

    PubMed

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

    2016-04-01

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

  14. 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.

  15. 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

  16. 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.

  17. 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

  18. 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.

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

    PubMed

    Rosemann, Achim

    2014-12-01

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

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

    SciTech Connect

    Blaise P. Collin

    2001-10-01

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

  1. 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

  2. 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.

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

    PubMed

    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.

  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. 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.)

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

    PubMed

    Ellouze, M; Augustin, J-C

    2010-03-31

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

  7. 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

  8. 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.

  9. 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

  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. 16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Exemptions from lead limits under section... 1500.88 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... stripe, the address electrode, the barrier ribs, the seal frit and frit ring as well as in print...

  12. 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

    ... Portal: http://www.regulations.gov . In the entry titled Enter Keyword or ID, enter BSEE-2012-0005 then click search. Follow the instructions to submit public comments and view supporting and related... proposed rulemaking on production safety systems on August 22, 2013 (78 FR 52240). The proposed rule...

  13. 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

    ... 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 public... With Implementation of U.S.P. 35 on a Global Basis. Pilot Program for Abbreviated Drug Inspections....

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

    PubMed

    Rotem, Avital; Henik, Avishai

    2015-01-01

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

  15. 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.

  16. 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

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2016-01-01

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

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

    ERIC Educational Resources Information Center

    Koraneekij, Prakob

    2008-01-01

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

  20. A Single-Subject Study of the Effects of Time on Task and Time of Day on Productivity and Achievement in a Dysgraphic Student.

    ERIC Educational Resources Information Center

    Morton, L. L.

    1986-01-01

    A single-subject study of the effects of time on task and time of day on written productivity in a dysgraphic learning-disabled fourth grader revealed that continuous adult direction increased time on task; that concurrent achievement gains using standardized tests accrued; and that enhanced writing productivity was evident in the afternoon.…

  1. A Thermal/Hydraulic Safety Assessment of the Blanket Conceptual Design for the Accelerator Production of Tritium Facility

    SciTech Connect

    Hamm, L.L.; Lee, S.Y.; Shadday, M.A.; Smith, F.G. III

    1998-09-01

    In support of the Accelerator Production of Tritium (APT) project, safety analyses for the blanket system have been performed based on the conceptual design for the Target/Blanket (T/B) Facility. During mitigated event sequences safety engineered features, such as the residual heat removal (RHR) and cavity flood systems, provide sufficient protection for maintaining the structural integrity of the blanket system and its components. During unmitigated (with beam shutdown only) event sequences, passive features such as natural circulation, thermal inertia, and boil-off provide significant time for corrective measures to be taken.

  2. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  3. 30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... indicated: (a) The International Electrotechnical Commission's (IEC) standards for Electrical Apparatus for..., Electrical Apparatus for Explosive Gas Atmospheres, Flameproof Enclosures “d” (IEC 60079-1, Fifth Edition.... Department of Labor, Mine Safety and Health Administration, Electrical Safety Division, Approval...

  4. 30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... indicated: (a) The International Electrotechnical Commission's (IEC) standards for Electrical Apparatus for..., Electrical Apparatus for Explosive Gas Atmospheres, Flameproof Enclosures “d” (IEC 60079-1, Fifth Edition.... Department of Labor, Mine Safety and Health Administration, Electrical Safety Division, Approval...

  5. 30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... indicated: (a) The International Electrotechnical Commission's (IEC) standards for Electrical Apparatus for..., Electrical Apparatus for Explosive Gas Atmospheres, Flameproof Enclosures “d” (IEC 60079-1, Fifth Edition.... Department of Labor, Mine Safety and Health Administration, Electrical Safety Division, Approval...

  6. 30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... indicated: (a) The International Electrotechnical Commission's (IEC) standards for Electrical Apparatus for..., Electrical Apparatus for Explosive Gas Atmospheres, Flameproof Enclosures “d” (IEC 60079-1, Fifth Edition.... Department of Labor, Mine Safety and Health Administration, Electrical Safety Division, Approval...

  7. 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.

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

    PubMed

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

    2016-02-01

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

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

    PubMed

    Porter, Catherine; Goyal, Radhika

    2016-06-01

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

  10. 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

  11. 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

  12. Shiga toxin-producing Escherichia coli: pre- and postharvest control measures to ensure safety of dairy cattle products.

    PubMed

    Hussein, Hussein S; Sakuma, Toshie

    2005-01-01

    The large number of cases of human illness caused by Shiga toxin-producing Escherichia coli (STEC) worldwide has raised safety concerns for foods of bovine origin. These human illnesses include diarrhea, hemorrhagic colitis, hemolytic uremic syndrome, and thrombotic thrombocytopenic purpura. Severe cases end with chronic renal failure, chronic nervous system deficiencies, and death. Over 100 STEC serotypes, including E. coli O157:H7, are known to cause these illnesses and to be shed in cattle feces. Thus, cattle are considered reservoirs of these foodborne pathogens. Because beef and dairy products were responsible for a large number of STEC outbreaks, efforts have been devoted to developing and implementing control measures that assure safety of foods derived from dairy cattle. These efforts should reduce consumers' safety concerns and support a competitive dairy industry at the production and processing levels. The efficacy of control measures both before harvest (i.e., on-farm management practices) and after harvest (i.e., milk processing and meat packing) for decreasing the risk of STEC contamination of dairy products was evaluated. The preharvest measures included sanitation during milking and management practices designed to decrease STEC prevalence in the dairy herd (i.e., animal factors, manure handling, drinking water, and both feeds and feeding). The postharvest measures included the practices or treatments that could be implemented during processing of milk, beef, or their products to eliminate or minimize STEC contamination.

  13. 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

  14. Medical Device Safety

    MedlinePlus

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

  15. 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

  16. 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

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

    PubMed

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

    2010-05-01

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

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

    PubMed

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

    2010-05-01

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

  19. 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

  20. 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.

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

    NASA Technical Reports Server (NTRS)

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

    2010-01-01

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

  2. 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

  3. 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…

  4. The Relationship between Organizational Climate and Selected Variables of Productivity-Reading Achievement, Teacher Experience and Teacher Attrition.

    ERIC Educational Resources Information Center

    Smith, Stanley Jeffery

    This study investigated the relationship between organizational climate and selected organizational variables--reading achievement, teacher experience, and teacher attrition. The study sample consisted of the total teaching staffs and 642 randomly selected students from five elementary schools in a metropolitan school district. Data were collected…

  5. 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.

  6. 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.

  7. 42 CFR 3.206 - Confidentiality of patient safety work product.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... prints; and (13) Full face photographic images and any comparable images; and (B) With respect to any... at 45 CFR 164.514(e)(2) have been removed. (5) Disclosure of nonidentifiable patient safety work... pursuant to paragraph (b)(6)(i) of this section is by a HIPAA covered entity as defined at 45 CFR...

  8. 42 CFR 3.206 - Confidentiality of patient safety work product.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... prints; and (13) Full face photographic images and any comparable images; and (B) With respect to any... at 45 CFR 164.514(e)(2) have been removed. (5) Disclosure of nonidentifiable patient safety work... pursuant to paragraph (b)(6)(i) of this section is by a HIPAA covered entity as defined at 45 CFR...

  9. 42 CFR 3.206 - Confidentiality of patient safety work product.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... prints; and (13) Full face photographic images and any comparable images; and (B) With respect to any... at 45 CFR 164.514(e)(2) have been removed. (5) Disclosure of nonidentifiable patient safety work... pursuant to paragraph (b)(6)(i) of this section is by a HIPAA covered entity as defined at 45 CFR...

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... prints; and (13) Full face photographic images and any comparable images; and (B) With respect to any... at 45 CFR 164.514(e)(2) have been removed. (5) Disclosure of nonidentifiable patient safety work... pursuant to paragraph (b)(6)(i) of this section is by a HIPAA covered entity as defined at 45 CFR...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

    ..., better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence... clinical trials. Second, by requiring expedited reports of certain safety information that was not reported... protect human subjects enrolled in clinical trials. Under the final rule, FDA will receive...

  12. A Novel Method for Assessing Drug Degradation Product Safety Using Physiologically-Based Pharmacokinetic Models and Stochastic Risk Assessment.

    PubMed

    Nguyen, Hoa Q; Stamatis, Stephen D; Kirsch, Lee E

    2015-09-01

    Patient safety risk due to toxic degradation products is a potentially critical quality issue for a small group of useful drug substances. Although the pharmacokinetics of toxic drug degradation products may impact product safety, these data are frequently unavailable. The objective of this study is to incorporate the prediction capability of physiologically based pharmacokinetic (PBPK) models into a rational drug degradation product risk assessment procedure using a series of model drug degradants (substituted anilines). The PBPK models were parameterized using a combination of experimental and literature data and computational methods. The impact of model parameter uncertainty was incorporated into stochastic risk assessment procedure for estimating human safe exposure levels based on the novel use of a statistical metric called "PROB" for comparing probability that a human toxicity-target tissue exposure exceeds the rat exposure level at a critical no-observed-adverse-effect level. When compared with traditional risk assessment calculations, this novel PBPK approach appeared to provide a rational basis for drug instability risk assessment by focusing on target tissue exposure and leveraging physiological, biochemical, biophysical knowledge of compounds and species. PMID:25900395

  13. A Novel Method for Assessing Drug Degradation Product Safety Using Physiologically-Based Pharmacokinetic Models and Stochastic Risk Assessment.

    PubMed

    Nguyen, Hoa Q; Stamatis, Stephen D; Kirsch, Lee E

    2015-09-01

    Patient safety risk due to toxic degradation products is a potentially critical quality issue for a small group of useful drug substances. Although the pharmacokinetics of toxic drug degradation products may impact product safety, these data are frequently unavailable. The objective of this study is to incorporate the prediction capability of physiologically based pharmacokinetic (PBPK) models into a rational drug degradation product risk assessment procedure using a series of model drug degradants (substituted anilines). The PBPK models were parameterized using a combination of experimental and literature data and computational methods. The impact of model parameter uncertainty was incorporated into stochastic risk assessment procedure for estimating human safe exposure levels based on the novel use of a statistical metric called "PROB" for comparing probability that a human toxicity-target tissue exposure exceeds the rat exposure level at a critical no-observed-adverse-effect level. When compared with traditional risk assessment calculations, this novel PBPK approach appeared to provide a rational basis for drug instability risk assessment by focusing on target tissue exposure and leveraging physiological, biochemical, biophysical knowledge of compounds and species.

  14. 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.

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

    PubMed

    Baron, Patrick; Frattaroli, Shannon

    2016-01-01

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

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

    PubMed 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

  17. 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

    2014-05-01

    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.

  18. Oxygen safety

    MedlinePlus

    COPD - oxygen safety; Chronic obstructive pulmonary disease - oxygen safety; Chronic obstructive airways disease - oxygen safety; Emphysema - oxygen safety; Heart failure - oxygen-safety; Palliative care - oxygen safety; ...

  19. 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.

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

    PubMed

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

    2001-06-01

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

  1. Enhancement of transglutaminase production in Streptomyces mobaraensis as achieved by treatment with excessive MgCl2.

    PubMed

    Zhang, Lili; Zhang, Lanwei; Han, Xue; Du, Ming; Zhang, Yingchun; Feng, Zhen; Yi, Huaxi; Zhang, Yanhe

    2012-03-01

    In this study, we first tested the capacity for eight different salts as stress-mediated bioprocesses in the production of transglutaminase (TGase). A significant effect on the cell growth and TGase production was obtained with the highest yield of TGase being observed at 96 h of incubation (4.3 U/ml) when the basic medium was supplemented 0.10 M MgCl(2), as opposed to that observed with the basic medium control (2.1 U/ml at 120 h). Data from Western blot assays showed that transformation of pro-TGase to its mature enzyme occurred more rapidly in MgCl(2) medium. Furthermore, total protease, metalloprotease, and serine protease were also synthesized at a faster rate in the medium containing MgCl(2). The results demonstrate that MgCl(2) enhanced the production of key proteases involved in the activation of TGase biosynthesis. To explore the mechanism, viability assay was performed. The results show that MgCl(2) induced the mycelia differentiation, decreased cell growth rate, and stimulated cell death. We argue that TGase production was promoted by the stimulation of mycelium differentiation induced by MgCl(2) stress.

  2. 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.

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

    PubMed

    Radnoff, Diane

    2013-01-01

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

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

    PubMed Central

    Babich, M A

    1998-01-01

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

  5. Hand Safety

    MedlinePlus

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

  6. Hand Safety

    MedlinePlus

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

  7. 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.

  8. 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

  9. Workplace Safety and Health Topics: Safety & Prevention

    MedlinePlus

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

  10. Screening of Lactobacillus isolated from pork sausages for potential probiotic use and evaluation of the microbiological safety of fermented products.

    PubMed

    Dias, Francesca Silva; Duarte, Whasley Ferreira; Santos, Marianna Rabelo Rios Martins; Ramos, Eduardo Mendes; Schwan, Rosane Freitas

    2013-06-01

    The aim of this study was to select strains of Lactobacillus isolated from pork sausage for use as probiotics. Lactobacillus isolates were evaluated in tests based on probiotic characteristics and microbiological safety. The UFLA SAU 14, 52, and 91 isolates were differentiated by coaggregation with Listeria monocytogenes, production of lactic acid, and survival at pH 2. UFLA SAU 172 and 187 isolates had high levels of coaggregation with Salmonella Typhi and Escherichia coli, tolerance to pancreatic fluid, and adhesion to chloroform. UFLA SAU 20 and 34 isolates were characterized by exopolysaccharide production, autoaggregation, and resistance to simulated intestinal fluid. UFLA SAU 185, 238, and 258 isolates exhibited resistance to bile and adhesion to xylene. A cocktail of these 10 Lactobacillus isolates with potential probiotic properties was inoculated into pork sausage and inhibited the growth of L. monocytogenes.

  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. Agricultural health in The Gambia II: A systematic survey of safety and injuries in production agriculture.

    PubMed

    Kuye, Rex; Donham, Kelley; Marquez, Shannon; Sanderson, Wayne; Fuortes, Laurence; Rautiainen, Risto; Jones, Martin; Culp, Kennith

    2006-01-01

    This study was undertaken to provide baseline information on the injuries and health and safety conditions in Gambian agriculture. The objective was to produce information to guide the formulation of an agricultural health and safety policy for the country, future investigations, prevention and surveillance of the adverse health effects in agriculture. A cross-sectional survey of 20 farmers, 20 nurses, and 20 agricultural extension workers was conducted in the Central and Upper River Divisions of The Gambia. The survey was implemented by the means of questionnaires, walk-through survey and hazard checklist. Seventy percent of farms reported an injury during the past year. Major sources and contributing factors for the injuries were characterized. Predisposing factors to the injuries were climatic conditions, working in static positions, bending and twisting and carrying heavy objects. Cuts and lacerations were identified as the commonest injury types and the most common sources were hand tools (hand hoe, cutlass, axe and knife) and animal-powered carts. A workshop for the major stake holders in the country's agriculture was also held to identify problems and possible solutions for health promotion of Gambian farmers.

  13. [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.

  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. PMID:22946164

  15. Codon optimization, promoter and expression system selection that achieved high-level production of Yarrowia lipolytica lipase in Pichia pastoris.

    PubMed

    Zhou, Wen-Jing; Yang, Jiang-Ke; Mao, Lin; Miao, Li-Hong

    2015-04-01

    Lipase (EC 3.1.1.3) stands amongst the most important and promising biocatalysts for industrial applications. In this study, in order to realize a high-level expression of the Yarrowia lipolytica lipase gene in Pichia pastoris, we optimized the codon of LIP2 by de novo gene design and synthesis, which significantly improved the lipase expression when compared to the native lip2 gene. We also comparatively analyzed the effects of the promoter types (PAOX1 and PFLD1) and the Pichia expression systems, including the newly developed PichiaPink system, on lipase production and obtained the optimal recombinants. Bench-top scale fermentation studies indicated that the recombinant carrying the codon-optimized lipase gene syn-lip under the control of promoter PAOX1 has a significantly higher lipase production capacity in the fermenter than other types of recombinants. After undergoing methanol inducible expression for 96h, the wet cell weight of Pichia, the lipase activity and the protein content in the fermentation broth reached their highest values of 262g/L, 38,500U/mL and 2.82g/L, respectively. This study has not only greatly facilitated the bioapplication of lipase in industrial fields but the strategies utilized, such as de novo gene design and synthesis, the comparative analysis among promoters and different generations of Pichia expression systems will also be useful as references for future work in this field. PMID:25765312

  16. 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.

  17. 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.

  18. 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 ...

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

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  20. 16 CFR Appendix to Part 1213 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  1. 16 CFR Appendix to Part 1213 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  2. 16 CFR Appendix to Part 1213 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  3. 16 CFR Appendix to Part 1213 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  4. 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...

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

    PubMed

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

    2009-07-01

    Food allergy is a potential risk associated with use of transgenic proteins in crops. Currently, safety assessment involves consideration of the source of the introduced protein, in silico amino acid sequence homology comparisons to known allergens, physicochemical properties, protein abundance in the crop, and, when appropriate, specific immunoglobulin E binding studies. Recently conducted research presented at an International Life Sciences Institute/Health and Environmental Sciences Institute-hosted workshop adds to the scientific foundation for safety assessment of transgenic proteins in five areas: structure/activity, serum screening, animal models, quantitative proteomics, and basic mechanisms. A web-based tool is now available that integrates a database of allergenic proteins with a variety of computational tools which could be used to improve our ability to predict allergenicity based on structural analysis. A comprehensive strategy and model protocols have been developed for conducting meaningful serum screening, an extremely challenging process. Several animal models using oral sensitization with adjuvant and one dermal sensitization model have been developed and appear to distinguish allergenic from non-allergenic food extracts. Data presented using a mouse model suggest that pepsin resistance is indicative of allergenicity. Certain questions remain to be addressed before considering animal model validation. Gel-free mass spectrometry is a viable alternative to more labor-intensive approaches to quantitative proteomics. Proteomic data presented on four nontransgenic varieties of soy suggested that if known allergen expression in genetically modified crops falls within the range of natural variability among commercial varieties, there appears to be no need to test further. Finally, basic research continues to elucidate the etiology of food allergy. PMID:19363142

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

    PubMed

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

    2009-07-01

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

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

    SciTech Connect

    Not Available

    1987-10-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2010-01-01

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

  10. 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.

  11. Patient Safety with Blood Products Administration Using Wireless and Bar-Code Technology

    PubMed Central

    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. Pilot period and preliminary house-wide data indicate improved error capture with the new barcode process over the old manual process. PMID:16779113

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

    PubMed

    Porcella, Aleta; Walker, Kristy

    2005-01-01

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

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

    SciTech Connect

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

    1992-07-01

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

  14. 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.

  15. 77 FR 35747 - Highway Safety Programs; Conforming Products List of Evidential Breath Alcohol Measurement Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

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

  16. [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.

  17. 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...

  18. 77 FR 64588 - Highway Safety Programs; Conforming Products List of Calibrating Units for Breath Alcohol Testers

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

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

  19. 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

    ... encompassed products for both health care and consumer use (39 FR 33103, September 13, 1974). The ANPR covered... handwash or health care personnel handwash (59 FR 31402 at 31442). Isopropyl alcohol 70 to 91.3 percent was... December 17, 2013 Part III Department of Health and Human Services Food and Drug Administration 21...

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

    PubMed

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

    2014-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

    Klinger, I; Rosenthal, I

    1997-08-01

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

  3. 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.

  4. 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.

  5. 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

  6. Product identification and safety evaluation of aflatoxin B1 decontaminated by electrolyzed oxidizing water.

    PubMed

    Xiong, Ke; Liu, Hai jie; Li, Li te

    2012-09-26

    In this study with aflatoxin-contaminated peanuts, the effectiveness of electrolyzed oxidizing water (EOW) in the decontamination of aflatoxin B(1) was investigated. The aflatoxin B(1) content was markedly reduced upon treatment with EOW, particularly with neutral electrolyzed oxidizing water (NEW). The conversion product of EOW treatment was isolated and identified as 8-chloro-9-hydroxy aflatoxin B(1) (compound 1), which is an amphiphilic molecule, in contrast to fat-soluble aflatoxin B(1). A mutagenic response study revealed that the number of revertants per plate after treatment of bacterial strains TA-97, TA-98, TA-100, and TA-102 with NEW was within the standard value range. The HepG2 cell viability assay yielded an IC(50) value of compound 1 approximately 150 mM. This study indicates that EOW had the ability to decontaminate aflatoxin B(1), and the conversion product, compound 1, did not exhibit mutagenic activity or cytotoxic effects.

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

    NASA Astrophysics Data System (ADS)

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

    2002-02-01

    Crystalline oxide ceramics, more particularly zirconia and spinel, are promising matrices for plutonium and minor actinide transmutation. An important issue concerning these materials is the investigation of their ability to confine radiotoxic elements resulting from the fission of actinides. This letter reports the study of the release, upon annealing or irradiation at high temperature, of one of the most toxic fission product (Cs) in zirconia. The foreign species are introduced by ion implantation and the release is studied by Rutherford backscattering experiments. The results emphasize the decisive influence of the fission product concentration on the release properties. The Cs mobility in zirconia is strongly increased when the impurity concentration exceeds a threshold of the order of a few atomic per cent. Irradiation with medium-energy heavy ions is shown to enhance Cs outdiffusion with respect to annealing at the same temperature.

  8. 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.

  9. Validation of the safety of MDCK cells as a substrate for the production of a cell-derived influenza vaccine.

    PubMed

    Onions, David; Egan, William; Jarrett, Ruth; Novicki, Deborah; Gregersen, Jens-Peter

    2010-09-01

    Cell culture-based production methods may assist in meeting increasing demand for seasonal influenza vaccines and developing production flexibility required for addressing influenza pandemics. MDCK-33016PF cells are used in propagation of a cell-based seasonal influenza vaccine (Optaflu); but, like most continuous cell lines, can grow in immunocompromised mice to produce tumors. It is, therefore, essential that no residual cells remain within the vaccine, that cell lysates or DNA are not oncogenic, and that the cell substrate does not contain oncogenic viruses or oncogenic DNA. Multiple, redundant processes ensure the safety of influenza vaccines produced in MDCK-33016PF cells. The probability of a residual cell being present in a dose of vaccine is approximately 1 in 10(34). Residual MDCK-DNA is < or =10 ng per dose and the ss-propiolactone used to inactivate influenza virus results in reduction of detectable DNA to less than 200 base pairs (bp). Degenerate PCR and specific PCR confirm exclusion of oncogenic viruses. The manufacturing process has been validated for its capacity to remove and inactivate viruses. We conclude that the theoretical risks arising from manufacturing seasonal influenza vaccine using MDCK-33016PF cells are reduced to levels that are effectively zero by the multiple, orthogonal processes used during production. PMID:20537553

  10. 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_ ...

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

    PubMed

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

    2014-06-01

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

  12. 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.

  13. 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.

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

    PubMed

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

    2016-04-01

    The dynamic expansion of the ready-to-eat seabream sector in its adaptation to new lifestyles has led to the search for new presentation formats in seabream (Sparus aurata). Green sauce (olive oil, wine vinegar, garlic, fresh parsley, black pepper, basil and salt) and 60 ℃ of cooking temperature were chosen by the panellists for the sous vide cooking process. Seabream fillet and sauce were packaged in polypropylene trays, cooked, chilled and stored at 2 ℃. Microbiological (total viable counts,Enterobacteriaceae,lactic acid bacteria, anaerobic psychrotrophic, moulds and yeasts, Salmonella and Listeria monocytogenes), chemical (pH and TBARs) and sensory parameters were determined at 0, 7, 17, 34, 48 and 62 days. In the conditions used, the microbiological counts remained stable, and Salmonella and Listeria monocytogenes were absent. The acidic sauce had a positive effect on the pH of the product, and low TBARs were obtained throughout storage. The processing conditions used in the present study allowed a chilled ready-to-eat seabream product of consistently high quality up to 62 days of storage to be obtained, representing an expansion of the products offered by the aquacultural industry. PMID:25941212

  15. 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.

  16. 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.

  17. [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. PMID:25518583

  18. 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.

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

    PubMed

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

    2015-07-01

    Construction safety management involves complex issues (e.g., different trades, multi-organizational project structure, constantly changing work environment, and transient workforce). Systems thinking is widely considered as an effective approach to understanding and managing the complexity. This paper aims to better understand dynamic complexity of construction safety management by exploring archetypes of construction safety. To achieve this, this paper adopted the ground theory method (GTM) and 22 interviews were conducted with participants in various positions (government safety inspector, client, health and safety manager, safety consultant, safety auditor, and safety researcher). Eight archetypes were emerged from the collected data: (1) safety regulations, (2) incentive programs, (3) procurement and safety, (4) safety management in small businesses (5) production and safety, (6) workers' conflicting goals, (7) blame on workers, and (8) reactive and proactive learning. These archetypes capture the interactions between a wide range of factors within various hierarchical levels and subsystems. As a free-standing tool, they advance the understanding of dynamic complexity of construction safety management and provide systemic insights into dealing with the complexity. They also can facilitate system dynamics modelling of construction safety process. PMID:25909389

  20. Efficacy and safety of Dr Michaels® (Soratinex®) product family for the topical treatment of psoriasis: a monitored status study.

    PubMed

    França, K; Novotny, F; Hercogovấ, J; Fioranelli, M; Gianfaldoni, S; Chokoeva, A A; Tchernev, G; Wollina, U; Tirant, M; Roccia, M G; Lotti, T

    2016-01-01

    The aim of the study was to investigate the efficacy and safety of Michaels® (Soratinex®) remedies in patients suffering from chronic plaque psoriasis in a Czech population. Seventy-five (34 female/41 male) patients, aged 18-72 years old (mean age: 38.5 years) with mild to severe plaque psoriasis participated in the study. The products, including cleansing gel, ointment and skin conditioner, containing fruit acid complex, herbal oils and emulsifiers, were used twice daily and in the same manner for all the skin lesions. The study period was eight weeks. Histologic variables and various blood picture parameters, including FW, glucose, cholesterol, triacylglyceroles, bilirubin, GMT, ALT, AST, creatinine, uric acid and urea in blood were monitored, before and after therapy with Michaels® (Soratinex®) treatment. Assessment, using the Psoriasis Activity Severity Index (PASI) scores and photographic analysis, was done at time 0, and after 2, 4, 6 and 8 weeks. Patient’s improvement was determined by the percentage reduction of the PASI scores. Side effects and tolerability were also evaluated. After 8 weeks using Dr Michaels® (Soratinex®) treatment course, 5 patients had a moderate improvement, with the resolution of 25-50% of skin lesions; 11 patients showed a good improvement, with the resolution of 51-75% of lesions. Another 50 patients had an outstanding improvement, with the regression of 76-100% of lesions. Only 4 patients did not achieve an improvement of psoriasis. Six patients experienced folliculitis, which resolved without cessation of treatment. Three patients worsened and discontinued treatment. Six patients dropped out because of non-compliance. The blood results and histologic findings were all normal. Our investigation shows that Dr Michaels® (Soratinex®) products can be safely and successfully used in the treatment of chronic plaque psoriasis. PMID:27498668

  1. Efficacy and safety of Dr Michaels® (Soratinex®) product family for the topical treatment of psoriasis: a monitored status study.

    PubMed

    França, K; Novotny, F; Hercogovấ, J; Fioranelli, M; Gianfaldoni, S; Chokoeva, A A; Tchernev, G; Wollina, U; Tirant, M; Roccia, M G; Lotti, T

    2016-01-01

    The aim of the study was to investigate the efficacy and safety of Michaels® (Soratinex®) remedies in patients suffering from chronic plaque psoriasis in a Czech population. Seventy-five (34 female/41 male) patients, aged 18-72 years old (mean age: 38.5 years) with mild to severe plaque psoriasis participated in the study. The products, including cleansing gel, ointment and skin conditioner, containing fruit acid complex, herbal oils and emulsifiers, were used twice daily and in the same manner for all the skin lesions. The study period was eight weeks. Histologic variables and various blood picture parameters, including FW, glucose, cholesterol, triacylglyceroles, bilirubin, GMT, ALT, AST, creatinine, uric acid and urea in blood were monitored, before and after therapy with Michaels® (Soratinex®) treatment. Assessment, using the Psoriasis Activity Severity Index (PASI) scores and photographic analysis, was done at time 0, and after 2, 4, 6 and 8 weeks. Patient’s improvement was determined by the percentage reduction of the PASI scores. Side effects and tolerability were also evaluated. After 8 weeks using Dr Michaels® (Soratinex®) treatment course, 5 patients had a moderate improvement, with the resolution of 25-50% of skin lesions; 11 patients showed a good improvement, with the resolution of 51-75% of lesions. Another 50 patients had an outstanding improvement, with the regression of 76-100% of lesions. Only 4 patients did not achieve an improvement of psoriasis. Six patients experienced folliculitis, which resolved without cessation of treatment. Three patients worsened and discontinued treatment. Six patients dropped out because of non-compliance. The blood results and histologic findings were all normal. Our investigation shows that Dr Michaels® (Soratinex®) products can be safely and successfully used in the treatment of chronic plaque psoriasis.

  2. 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

    ... operate properly or if any fluid flow is observed during the leakage test, the valve must be immediately... Specifications for subsurface safety valves (SSSVs)--dry trees. Sec. 250.812 Surface- controlled SSSVs--dry trees... safety valves safety systems. (SSVs). Sec. 250.820 Use of SSVs. Sec. 250.833 Specification for...

  3. 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

  4. 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

  5. Prevalence of antibiotic resistance in coagulase-negative staphylococci from spontaneously fermented meat products and safety assessment for new starters.

    PubMed

    Marty, Esther; Bodenmann, Chantal; Buchs, Jasmin; Hadorn, Ruedi; Eugster-Meier, Elisabeth; Lacroix, Christophe; Meile, Leo

    2012-10-01

    To provide new meat starter strains lacking antibiotic (AB) resistances, we explored the AB susceptibility in 116 coagulase-negative Staphylococcus (CNS) isolates from traditionally fermented sausages (n=40) manufactured with meat from conventional animal breeding, and from meat products (n=76) made from meat of animals raised in natural habitats under low- or no-antibiotic pressure. Less than 50% of these CNS isolates showed phenotypic resistances to at least one antibiotic (AB) by using microdilution assay. Resistances to penicillins and tetracycline were most often observed and could be traced back to blaZ and tet(K) genes. Prevalence of AB resistances was species-dependent and mainly found in isolates of Staphylococcus warneri (78%), Staphylococcus capitis (75%) and Staphylococcus epidermidis (67%), but only sporadically detected in Staphylococcus carnosus (27%) and Staphylococcus equorum (18%). AB resistances were more often observed in S. xylosus isolates originating from natural habitats compared to traditionally fermented sausages made from conventional meat. A selection of 101 isolates belonging to S. xylosus (n=63), S. carnosus (n=21) and S. equorum (n=17) were subsequently grouped by pulsed-field gel electrophoresis (PFGE) into strain clusters. No S. carnosus and only five S. xylosus strains were lacking AB resistances and exhibited a PFGE genotype different from commercial starters. These strains, together with 17 S. equorum strains, were further studied for safety and technological characteristics. The ability to produce biogenic amines was not detected in any strain. PCR amplifications for enterotoxin encoding genes seg-sej were detected in one, and for δ-hemolysin encoding gene hld in four S. equorum strains, but phenotypic hemolytic activity was visible for three S. xylosus and 15 S. equorum strains. Catalase and nitrate reductase activity was observed in all isolates tested; particularly S. equorum showed high nitrate reduction. In conclusion, we

  6. Current concepts on integrative safety assessment of active substances of botanical, mineral or chemical origin in homeopathic medicinal products within the European regulatory framework.

    PubMed

    Buchholzer, Marie-Luise; Werner, Christine; Knoess, Werner

    2014-03-01

    For active substances of botanical, mineral or chemical origin processed in homeopathic medicinal products for human use, the adequate safety principles as with other human medicinal products are applied in line with the European regulatory framework. In homeopathy, nonclinical safety assessment is facing a particular challenge because of a multitude and diversity of source materials used and due to rarely available toxicological data. Thus, current concepts applied by the national regulatory authority in Germany (BfArM) on integrative safety assessment of raw materials used in homeopathic medicinal products involve several evaluation approaches like the use of the Lowest Human Recommended Dose (LHRD), toxicological limit values, Threshold of Toxicological Concern (TTC), data from food regulation or the consideration of unavoidable environmental or dietary background exposure. This publication is intended to further develop and clarify the practical use of these assessment routes by exemplary application on selected homeopathic preparations. In conclusion, the different approaches are considered a very useful scientific and simultaneously pragmatic procedure in differentiated risk assessment of homeopathic medicinal products. Overall, this paper aims to increase the visibility of the safety issues in homeopathy and to stimulate scientific discussion of worldwide existing regulatory concepts on homeopathic medicinal products.

  7. 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.

  8. 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.

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

    PubMed

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

    2015-12-01

    We evaluated the possibility of introducing a combination of six oncogenes into primary porcine hepatocytes (PPH) using a lentiviral vector (LV)-mediated gene transfer in order to develop a porcine hepatocellular carcinoma model based on autologous transplantation of ex vivo-transformed hepatocytes. The six oncogenes were introduced into three plasmids, hence enabling the production of LVs encoding a luciferase reporter gene and hTERT+p53(DD), cyclinD1+CDK4(R24C), and c-myc(T58A)+HRas(G21V) genes, respectively. In order to improve the protection of the laboratory personnel manipulating such LVs, we used a compact cell culture cassette (CliniCell(®) device) as a closed cell culture system. We demonstrated that the CliniCell device allows to produce LVs, through plasmid transfection of 293T cells, and, after transfer to a second cassette, to transduce PPH with a similar efficacy as conventional open cell culture systems such as flasks or Petri dishes. Additionally, it is possible to cryopreserve at -80°C the transduced cells, directly in the CliniCell device used for the transduction. In conclusion, the use of a closed culture system for the safe handling of oncogene-encoding LVs lays the foundation for the development of porcine tumor models based on the autologous transplantation of ex vivo-transformed primary cells. PMID:26467420

  10. 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.

  11. Knowledge and attitudes toward food safety and use of good production practices among Canadian broiler chicken producers.

    PubMed

    Young, Ian; Rajić, Andrijana; Letellier, Ann; Cox, Bill; Leslie, Mira; Sanei, Babak; McEwen, Scott A

    2010-07-01

    Provincial broiler-chicken marketing boards in Canada have recently implemented an on-farm food safety program called Safe, Safer, Safest. The purpose of this study was to measure broiler chicken producers' attitudes toward the program and food safety topics and use of highly recommended good production practices (GPP). Mailed and Web-based questionnaires were administered to all producers registered in British Columbia, Ontario, and Quebec in 2008. The response percentage was 33.2% (642 of 1,932). Nearly 70% of respondents rated the program as effective in producing safe chicken, and 49.1% rated the program requirements as easy to implement. Most respondents (92.9%) reported that they do not raise other poultry or keep birds as pets, and 79.8% reported that they clean and disinfect their barns between each flock cycle. Less than 50% of respondents reported that visitors wash their hands or change their clothes before entering barns, 38.4% reported that catching crews wear clean clothes and boots, and 35.8% reported that a crew other than from the hatchery places chicks. Respondents who rated the program requirements as effective or easy to implement were more likely to report the use of five of six highly recommended GPP. Only 21.1% of respondents indicated that Campylobacter can be transmitted from contaminated chicken meat to humans, and 26.6% believed that antimicrobial use in their industry is linked to antimicrobial resistance in humans. Continuing education of producers should focus on improving their awareness of these issues, while mandatory GPP should include those that are known to be effective in controlling Campylobacter and Salmonella in broiler chicken flocks.

  12. How does the efficacy and safety of Oralair(®) compare to other products on the market?

    PubMed

    Larenas-Linnemann, Désirée

    2016-01-01

    Due to differences between allergen immunotherapy (AIT) trials in patient populations, trial design (including primary efficacy variables), the definition of a pollen season, data analysis, and comparisons between AIT products with existing data, is not possible nor valid. The efficacy of two grass pollen AIT tablets, Oralair(®) and Grazax(®)/Grastek(®), should not be compared by looking at the percentage of score improvement in their respective trials. However, the evidence available concerning the efficacy and safety in trials can be compared by paying close attention to the scientific quality of the trials, details in the administration schedules, and safety issues. It can be concluded due to the high level of evidence available, that Oralair(®) is effective in a pre (2-months)-coseasonal schedule to reduce symptoms and medication use, and improve a patients' quality of life during the treatment season. For the long-term, where the quality of efficacy evidence is moderate at 2-year posttreatment due to a high dropout rate, the pre (4-months)-coseasonal schedule should be used. No clinical efficacy data exists for starting treatment in-season, but the clinical onset of action of Oralair(®) is detectable after only 1 month of treatment. In the pivotal trials in Europe and the USA, no tablet-related epinephrine was needed, though some rare severe local reactions have been reported. Research for Grazax(®)/Grastek(®) showed that the long-term efficacy needs a continuous 3-year administration (moderate-low quality evidence available), and in two patients, tablet-related epinephrine was given. Further details on the comparative efficacy of both tablets would only be possible if both were evaluated in the same, adequately powered trial. PMID:27313458

  13. How does the efficacy and safety of Oralair® compare to other products on the market?

    PubMed Central

    Larenas-Linnemann, Désirée

    2016-01-01

    Due to differences between allergen immunotherapy (AIT) trials in patient populations, trial design (including primary efficacy variables), the definition of a pollen season, data analysis, and comparisons between AIT products with existing data, is not possible nor valid. The efficacy of two grass pollen AIT tablets, Oralair® and Grazax®/Grastek®, should not be compared by looking at the percentage of score improvement in their respective trials. However, the evidence available concerning the efficacy and safety in trials can be compared by paying close attention to the scientific quality of the trials, details in the administration schedules, and safety issues. It can be concluded due to the high level of evidence available, that Oralair® is effective in a pre (2-months)-coseasonal schedule to reduce symptoms and medication use, and improve a patients’ quality of life during the treatment season. For the long-term, where the quality of efficacy evidence is moderate at 2-year posttreatment due to a high dropout rate, the pre (4-months)-coseasonal schedule should be used. No clinical efficacy data exists for starting treatment in-season, but the clinical onset of action of Oralair® is detectable after only 1 month of treatment. In the pivotal trials in Europe and the USA, no tablet-related epinephrine was needed, though some rare severe local reactions have been reported. Research for Grazax®/Grastek® showed that the long-term efficacy needs a continuous 3-year administration (moderate-low quality evidence available), and in two patients, tablet-related epinephrine was given. Further details on the comparative efficacy of both tablets would only be possible if both were evaluated in the same, adequately powered trial. PMID:27313458

  14. 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

  15. Safety and anti-HIV assessments of natural vaginal cleansing products in an established topical microbicides in vitro testing algorithm

    PubMed Central

    2010-01-01

    Background At present, there is no effective vaccine or other approved product for the prevention of sexually transmitted human immunodeficiency virus type 1 (HIV-1) infection. It has been reported that women in resource-poor communities use vaginally applied citrus juices as topical microbicides. These easily accessible food products have historically been applied to prevent pregnancy and sexually transmitted diseases. The aim of this study was to evaluate the efficacy and cytotoxicity of these substances using an established topical microbicide testing algorithm. Freshly squeezed lemon and lime juice and household vinegar were tested in their original state or in pH neutralized form for efficacy and cytotoxicity in the CCR5-tropic cell-free entry and cell-associated transmission assays, CXCR4-tropic entry and fusion assays, and in a human PBMC-based anti-HIV-1 assay. These products were also tested for their effect on viability of cervico-vaginal cell lines, human cervical explant tissues, and beneficial Lactobacillus species. Results Natural lime and lemon juice and household vinegar demonstrated anti-HIV-1 activity and cytotoxicity in transformed cell lines. Neutralization of the products reduced both anti-HIV-1 activity and cytotoxicity, resulting in a low therapeutic window for both acidic and neutralized formulations. For the natural juices and vinegar, the IC50 was ≤ 3.5 (0.8-3.5)% and the TC50 ≤ 6.3 (1.0-6.3)%. All three liquid products inhibited viability of beneficial Lactobacillus species associated with vaginal health. Comparison of three different toxicity endpoints in the cervical HeLa cell line revealed that all three products affected membrane integrity, cytosolic enzyme release, and dehydrogenase enzyme activity in living cells. The juices and vinegar also exerted strong cytotoxicity in cervico-vaginal cell lines, mainly due to their acidic pH. In human cervical explant tissues, treatment with 5% lemon or lime juice or 6% vinegar induced

  16. 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.

  17. Assessment of control measures to achieve a food safety objective of less than 100 CFU of Listeria monocytogenes per gram at the point of consumption for fresh precut iceberg lettuce.

    PubMed

    Szabo, E A; Simons, L; Coventry, M J; Cole, M B

    2003-02-01

    The important new concept of the food safety objective (FSO) offers a strategy to translate public health risk into a definable goal such as a specified maximum frequency or concentration of a hazardous agent in a food at the time of consumption that is deemed to provide an appropriate level of health protection. For the foodborne pathogen Listeria monocytogenes, there is a proposed FSO of < 100 CFU/g in ready-to-eat (RTE) products at the time of consumption. Fresh precut iceberg lettuce is one of these RTE products. In this study, we worked with a commercial manufacturer to evaluate the effectiveness of two antimicrobial washing agents (sodium hypochlorite and a mixture of hydrogen peroxide and peroxyacetic acid) against L. monocytogenes under simulated fresh precut washing conditions and evaluated the growth potential of this pathogen on lettuce packaged in a gas-permeable film and stored at 4 or 8 degrees C for 14 days. We used the results of this experiment to demonstrate how the commercial manufacturer could meet the FSO for L. monocytogenes in fresh precut lettuce through the application of performance, process, and microbiological criteria.

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

    PubMed

    Roth, Eva; Rosenthal, Harald

    2006-01-01

    Over the past years the export of agricultural and fishery products from developing countries has substantially increased to markets within the OECD. Retailers and importers are expanding their international operations to meet consumer demands for year-round delivery of products. Moreover, consumers have become increasingly concerned about the safety of food, including those derived from aquatic resources [FAO/NACA/WHO Joint Study Group, 1999. Report food safety issues associated with products from aquaculture. WHO Technical Report Series No 883: VII, pp. 1-55]. Governments and leading businesses are responding by imposing new safety regulations and standards to the international food system (e.g. HACCP, EUREP-GAP), product liability and labeling [Reilly, A., Howgate, P., Käferstein, F., 1997. Safety hazards and the application of HACCP in aquaculture. In: Proceedings of the Second International Conference on Fish Inspection and Quality Control: A Global Focus, Arlington, VA, 19-24 May 1996. Technomic Publishing, Lancaster, PA, pp. 353-373]. Initial concerns for imports of aquacultural products from developing to industrialized countries focussed on bacterial contamination [Buras, N. 1993. Microbial safety of produce from wastewater-fed aquaculture. In: Pullin, R.V.C., Rosenthal, H., MacLean, J.L.(Eds.), Proceedings of ICLARM Conferences, vol. 31, pp. 285-295]. Today, if trade opportunities are to be maintained, these countries must adapt to a full array of regulations and standards. This paper describes four scenarios in aquaculture and fishing product trade between developing countries and countries in the European Union. PMID:17070860

  19. 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.

  20. 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

  1. 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.

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

    PubMed

    Vujić, Mario; Pollak, Lea

    2015-12-01

    The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union "nutrivigilance" system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family. PMID:26751855

  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. 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

  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. 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.

  7. 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.

  8. 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

  9. 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.

  10. Achieving household nutrition security in societies in transition: an overview.

    PubMed

    Gopalan, C

    2001-01-01

    The achievement of nutrition security at the household level involves adequacy of food supply at the national level and equitable distribution of food among the population in accordance with their physiological needs. The emergence of globalization and market liberalization and the increasing power of some transnational corporations that are advocating pharmaceutical shortcuts have raised concerns in many developing countries. In order to achieve adequacy of food production, earlier mistakes (such as a reliance on unsustainable new technologies) need to be corrected and the resultant imbalances with respect to food production need to be reversed. Emerging new technologies, including genetic modifications, need to be effectively harnessed and adapted with due consideration to safety and sustainability. There is a need to collect convincing evidence of the efficacy and safety of genetically modified foods before they can gain general public acceptance. Information technology will play an important role in future programmes of food production and developing countries must strive to achieve access to this technology. There is considerable scope and need for the expansion of agro-based industries in villages and townships. This could create job opportunities and could also lead to better production and more effective utilization of local food resources by the community and reduce the present considerable loss of perishable food items. Household nutrition security means more than avoidance of chronic starvation. Policy makers of developing countries should set, as their target in the next century, the achievement of adequate nutrition rather than mere survival.

  11. 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.

  12. 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...

  13. 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...

  14. Safety features of subcritical fluid fueled systems

    NASA Astrophysics Data System (ADS)

    Bell, Charles R.

    1995-09-01

    Accelerator-driven transmutation technology has been under study at Los Alamos for several years for application to nuclear waste treatment, tritium production, energy generation, and recently, to the disposition of excess weapons plutonium. Studies and evaluations performed to date at Los Alamos have led to a current focus on a fluid-fuel, fission system operating in a neutron source-supported subcritical mode, using molten salt reactor technology and accelerator-driven proton-neutron spallation. In this paper, the safety features and characteristics of such systems are explored from the perspective of the fundamental nuclear safety objectives that any reactor-type system should address. This exploration is qualitative in nature and uses current vintage solid-fueled reactors as a baseline for comparison. Based on the safety perspectives presented, such systems should be capable of meeting the fundamental nuclear safety objectives. In addition, they should be able to provide the safety robustness desired for advanced reactors. However, the manner in which safety objectives and robustness are achieved is very different from that associated with conventional reactors. Also, there are a number of safety design and operational challenges that will have to be addressed for the safety potential of such systems to be credible.

  15. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    .... Bromfenac sodium: All drug products containing bromfenac sodium. Butamben: All parenteral drug products containing butamben. Camphorated oil: All drug products containing camphorated oil. Carbetapentane citrate: All oral gel drug products containing carbetapentane citrate. Casein, iodinated: All drug...

  16. 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.

  17. 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

    ... containing metabromsalan. Methamphetamine hydrochloride: All parenteral drug products containing methamphetamine hydrochloride. Methapyrilene: All drug products containing methapyrilene. Methopholine: All...

  18. 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

    ... containing metabromsalan. Methamphetamine hydrochloride: All parenteral drug products containing methamphetamine hydrochloride. Methapyrilene: All drug products containing methapyrilene. Methopholine: All...

  19. Safety Relies on Climate

    ERIC Educational Resources Information Center

    Kinney, Patti

    2009-01-01

    One of the most important challenges of a principal's day is that of building and maintaining a school culture that promotes safety and supports learning. So it should come as no surprise to experienced educators that school safety and positive school climate directly affect academic achievement. This article discusses how principals can build an…

  20. 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

    ...; Boarding shut down valves (BSDV); and Equipment used for high temperature and high pressure wells. Rewrite... new alloys and equipment for high temperature and high pressure wells. Another major change to the... installed in high safety valves (SSSVs) and pressure high temperature (HPHT) related equipment installed...

  1. 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…

  2. Safety evaluation of sous vide-processed products with respect to nonproteolytic Clostridium botulinum by use of challenge studies and predictive microbiological models.

    PubMed

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

    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 degrees 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 degrees 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

  3. 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

  4. 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.

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

    PubMed

    Van Scyoc, Karl

    2008-11-15

    Process safety practitioners have adopted quality management principles in design of process safety management systems with positive effect, yet achieving safety objectives sometimes remain a distant target. Companies regularly apply tools and methods which have roots in quality and productivity improvement. The "plan, do, check, act" improvement loop, statistical analysis of incidents (non-conformities), and performance trending popularized by Dr. Deming are now commonly used in the context of process safety. Significant advancements in HSE performance are reported after applying methods viewed as fundamental for quality management. In pursuit of continual process safety improvement, the paper examines various quality improvement methods, and explores how methods intended for product quality can be additionally applied to continual improvement of process safety. Methods such as Kaizen, Poke yoke, and TRIZ, while long established for quality improvement, are quite unfamiliar in the process safety arena. These methods are discussed for application in improving both process safety leadership and field work team performance. Practical ways to advance process safety, based on the methods, are given. PMID:18374483

  6. 78 FR 33836 - CPSC Safety Academy

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY COMMISSION CPSC Safety Academy AGENCY: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: The Consumer Product Safety Commission (CPSC, Commission, or we) is announcing its intent to hold a...

  7. [Requirements for long-term follow-up on efficacy and safety of advanced therapy medicinal products. Risk management and traceability].

    PubMed

    Klug, B; Reinhardt, J; Schröder, C

    2010-01-01

    Advanced therapy medicinal products (ATMPs) are an innovative treatment option. To promote timely access of the innovative medicinal product and to safeguard public health, new elements have been introduced into legislation. A key element of the ATMP regulation is the requirement for long-term follow-up on safety and efficacy of patients enrolled in clinical trials with ATMPs, which is beyond the routine requirements on pharmacovigilance. For gene therapy medicinal products, a guideline on long-term follow-up, which lays down the technical requirements, is available. A further key element of the ATMP regulation is the traceability of the starting materials used to manufacture the ATMP. A common European coding system is imperative to ensure the traceability of starting materials, especially across the borders of European Member States.

  8. 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.

  9. 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

  10. 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…

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

    PubMed

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

    2014-07-01

    We described characteristics of the Escherichia coli O157 and Escherichia coli non-O157 illness investigations conducted by the United States Department of Agriculture's Food Safety and Inspection Service (FSIS) during the 5-year period from 2006 through 2010. We created a multivariable logistic regression model to determine characteristics of these investigations that were associated with FSIS regulatory action, which was defined as having occurred if a product recall occurred or if FSIS personnel performed an environmental health assessment (Food Safety Assessment) at the implicated establishment. During this period, FSIS took regulatory action in 38 of 88 (43%) investigations. Illness investigations in which FoodNet states were involved were more likely to result in regulatory action. Illness investigations in which state and local traceback, or FSIS traceback occurred were more likely to result in regulatory action. Reasons for lack of action included evidence of cross-contamination after the product left a regulated establishment, delayed notification, lack of epidemiological information, and insufficient product information. PMID:24826872

  12. 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.

  13. Workplace Safety: Indoor Environmental Quality

    MedlinePlus

    ... message, please visit this page: About CDC.gov . Workplace Safety & Health Topics Indoor Environmental Quality Health Hazard Evaluation ... Pinterest Twitter YouTube NIOSH Homepage NIOSH A-Z Workplace Safety & Health Topics Publications and Products Programs Contact NIOSH ...

  14. Safety Training in Reed International

    ERIC Educational Resources Information Center

    Ridley, J.

    1974-01-01

    The safety training provided within Reed International Limited and its relationship to production operations are outlined, demonstrating that safety works when management is committed to it on both humanitarian and economic grounds. (MW)

  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. 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.

  17. 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 ...

  18. Project LEAP: The Labor Education Achievement Program. A Program To Improve the Literacy Level and Productivity of the Workforce. Final Project Report. April 1, 1991-September 30, 1992.

    ERIC Educational Resources Information Center

    Metropolitan Baltimore Council of AFL-CIO Unions, MD.

    Maryland's Labor Education Achievement Program (LEAP) worked with a wide diversity of union workers in multiple industries and within numerous private companies and public agencies over a dispersed geographic area. Staff development included a workshop for local coordinators and a teacher inservice training session. LEAP provided…

  19. 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…

  20. [Chemical analytical aspects of hygiene safety of the use of methyl tertiary-butyl ether in the production of gasoline].

    PubMed

    Malysheva, A G; Rastyannikov, E G; Kozlova, N Yu; Artyushina, I Yu

    2014-01-01

    There was developed, certified and recommended for the practical application the technique for control in the water used as a high-octane oxygenated gasoline additive methyl tert-butyl ether with the use of chromatography-mass spectrometry method with a sensitivity of (0.005 mg/dm3) below the level of existing foreign regulations. Technique is introduced into the Federal Information Fund to ensure the unity of measurements. The possibility of applying the proposed method of analysis for monitoring chemical contamination of water sources and the quality control and safety of drinking water has been shown.

  1. 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…

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. Safety's impact on an alternative energy source

    SciTech Connect

    Denton, D.K.

    1983-01-01

    Our ability to make underground mines a safe place to work will be a major concern to those seeking to use coal as an energy source. Increased production will stimulate a heightened concern for making mining a more effective energy resource. This effectiveness means that unless safe performance is achieved, the cost of poor safety, such as loss of lives and costly delays due to breakdowns and other failures, will greatly reduce productivity of underground mining operations. As such, coal companies and miners must be prepared to safely manage their operation before underground mining makes a significant effect on energy independence.

  7. 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

  8. Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. Final rule.

    PubMed

    2016-09-01

    The Food and Drug Administration (FDA, we, or the Agency) is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC consumer antiseptic wash products that have come to the Agency's attention. This final rule amends the 1994 tentative final monograph (TFM) for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA.

  9. Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. Final rule.

    PubMed

    2016-09-01

    The Food and Drug Administration (FDA, we, or the Agency) is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC consumer antiseptic wash products that have come to the Agency's attention. This final rule amends the 1994 tentative final monograph (TFM) for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA. PMID:27632802

  10. 16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... children's activities, and the aging of the product, as determined by the Commission. Paint, coatings, or... oxide in plasma display panels (PDP) and surface conduction electron emitter displays (SED) used...

  11. 16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... children's activities, and the aging of the product, as determined by the Commission. Paint, coatings, or... oxide in plasma display panels (PDP) and surface conduction electron emitter displays (SED) used...

  12. 16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... children's activities, and the aging of the product, as determined by the Commission. Paint, coatings, or... oxide in plasma display panels (PDP) and surface conduction electron emitter displays (SED) used...

  13. 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

    ... children's activities, and the aging of the product, as determined by the Commission. Paint, coatings, or... oxide in plasma display panels (PDP) and surface conduction electron emitter displays (SED) used...

  14. Analytical criteria for performance characteristics of IgE binding methods for evaluating safety of biotech food products.

    PubMed

    Holzhauser, Thomas; Ree, Ronald van; Poulsen, Lars K; Bannon, Gary A

    2008-10-01

    There is detailed guidance on how to perform bioinformatic analyses and enzymatic degradation studies for genetically modified crops under consideration for approval by regulatory agencies; however, there is no consensus in the scientific community on the details of how to perform IgE serum studies. IgE serum studies are an important safety component to acceptance of genetically modified crops when the introduced protein is novel, the introduced protein is similar to known allergens, or the crop is allergenic. In this manuscript, we describe the characteristics of the reagents, validation of assay performance, and data analysis necessary to optimize the information obtained from serum testing of novel proteins and genetically modified (GM) crops and to make results more accurate and comparable between different investigations. PMID:18727951

  15. Towards a Three-Dimensional Near-Real Time Cloud Product for Aviation Safety and Weather Diagnoses

    NASA Technical Reports Server (NTRS)

    Minnis, Patrick; Nguyen, Louis; Palikonda, Rabindra; Spangeberg, Douglas; Nordeen, Michele L.; Yi, Yu-Hong; Ayers, J. Kirk

    2004-01-01

    Satellite data have long been used for determining the extent of cloud cover and for estimating the properties at the cloud tops. The derived properties can also be used to estimate aircraft icing potential to improve the safety of air traffic in the region. Currently, cloud properties and icing potential are derived in near-real time over the United States of America (USA) from the Geostationary Operational Environmental Satellite GOES) imagers at 75 W and 135 W. Traditionally, the results have been given in two dimensions because of the lack of knowledge about the vertical extent of clouds and the occurrence of overlapping clouds. Aircraft fly in a three-dimensional space and require vertical as well as horizontal information about clouds, their intensity, and their potential for icing. To improve the vertical component of the derived cloud and icing parameters, this paper explores various methods and datasets for filling in the three-dimensional space over the USA with cloud water.

  16. Analytical criteria for performance characteristics of IgE binding methods for evaluating safety of biotech food products.

    PubMed

    Holzhauser, Thomas; Ree, Ronald van; Poulsen, Lars K; Bannon, Gary A

    2008-10-01

    There is detailed guidance on how to perform bioinformatic analyses and enzymatic degradation studies for genetically modified crops under consideration for approval by regulatory agencies; however, there is no consensus in the scientific community on the details of how to perform IgE serum studies. IgE serum studies are an important safety component to acceptance of genetically modified crops when the introduced protein is novel, the introduced protein is similar to known allergens, or the crop is allergenic. In this manuscript, we describe the characteristics of the reagents, validation of assay performance, and data analysis necessary to optimize the information obtained from serum testing of novel proteins and genetically modified (GM) crops and to make results more accurate and comparable between different investigations.

  17. Overview of current meat hygiene and safety risks and summary of recent studies on biofilms, and control of Escherichia coli O157:H7 in nonintact, and Listeria monocytogenes in ready-to-eat, meat products.

    PubMed

    Sofos, John N; Geornaras, Ifigenia

    2010-09-01

    As meat consumption is increasing around the world, so do concerns and challenges to meat hygiene and safety. These concerns are mostly of a biological nature and include bacterial pathogens, such as Escherichia coli O157:H7, Salmonella and Campylobacter in raw meat and poultry, and Listeria monocytogenes in ready-to-eat processed products, while viral pathogens are of major concern at foodservice. A major goal of scientists, industry, public health and regulatory authorities is to control pathogenic microorganisms and improve meat product hygiene and safety within a country and internationally. This paper is not a comprehensive or critical review of the scientific literature on the broad area of meat hygiene and safety, but it provides an overview of major current meat hygiene and safety issues, and then a summary of studies on biofilm formation by pathogens, control of E. coli O157:H7 in nonintact meat products, and control of L. monocytogenes in ready-to-eat meat products, conducted at the Center for Meat Safety & Quality and Food Safety Cluster of Colorado State University in recent years.

  18. Eye Safety for Emergency Response and Disaster Recovery

    MedlinePlus

    ... message, please visit this page: About CDC.gov . Workplace Safety & Health Topics Eye Safety Eye Safety for Emergency ... Pinterest Twitter YouTube NIOSH Homepage NIOSH A-Z Workplace Safety & Health Topics Publications and Products Programs Contact NIOSH ...

  19. 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.

  20. 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.