WorldWideScience

Sample records for biological product safety

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    2010-09-29

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

  3. A Product Safety Primer

    Science.gov (United States)

    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)

  4. 75 FR 59935 - Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and...

    Science.gov (United States)

    2010-09-29

    ... the developing safety profile of the drug, expedite FDA's review of critical safety information... will minimize reports that do not contribute to FDA's understanding of the developing safety profile of...., hepatic necrosis would be considered unexpected where the investigator brochure includes elevated...

  5. Consumer Product Safety Bills.

    Science.gov (United States)

    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…

  6. Book review: Safety of Biologics Therapy

    Directory of Open Access Journals (Sweden)

    Robak T

    2017-01-01

    Full Text Available Tadeusz Robak Department of Hematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, PolandSafety of Biologics Therapy: Monoclonal Antibodies, Cytokines, Fusion Proteins, Hormones, Enzymes, Coagulation Proteins, Vaccines, Botulinum Toxins (Cham, Switzerland: Springer International Publishing; 2016 by Brian A Baldo from the Molecular Immunology Unit, Kolling Institute of Medical Research, Royal North Shore Hospital of Sydney, and the Department of Medicine, University of Sydney, Australia, is a book that belongs on the shelf of everyone in the field of biologic therapies research and clinical practice. In writing this book, the author’s intention was to produce an up-to-date text book on approved biologic therapies, as far as that is possible in this time of rapidly evolving developments in biotherapeutic research and the introduction of new and novel agents for clinical use.The monograph comprises 610 pages in 13 chapters, each including a summary and further reading suggestions. All chapters include a discussion of basic and clinical material. Well-designed, comprehensive tables and color figures are present throughout the book. The book itself examines the biologic products that have regulatory approval in the USA and/or European Union and that show every indication of remaining important therapies. It covers in great detail all the latest work on peptide hormones and enzymes, monoclonal antibodies, fusion proteins, and cytokine therapies. Beyond that, it also presents the latest information on blood coagulation proteins, vaccines, botulinum neurotoxins, and biosimilars. 

  7. FDA 101: Regulating Biological Products

    Science.gov (United States)

    ... Products For Consumers Home For Consumers Consumer Updates FDA 101: Regulating Biological Products Share Tweet Linkedin Pin ... field. back to top What biological products does FDA regulate? The Center for Biologics Evaluation and Research ( ...

  8. Biologic Therapy in Psoriasis: Safety Profile.

    Science.gov (United States)

    Campanati, Anna; Ganzetti, Giulia; Giuliodori, K; Molinelli, Elisa; Offidani, A

    2016-01-01

    This review focuses on the emerging concepts concerning the efficacy profile of biological drugs in psoriasis ranging from moderate to severe, and attempts to provide the most recent individual positioning of biologics in treating psoriasis. Biologic agents targeting towards specific immune mediators have emerged as treatment options for patients with moderate to-severe plaque psoriasis unresponsive or intolerant to traditional systemic agents. Data on the safety of biologics are available for up to 5 years in psoriasis and are on the whole reassuring. National registries are still evolving and will provide data on safety, to help the long-term monitoring of patients with psoriasis ongoing biological treatment. Although several biologics have demonstrated good efficacy and tolerability in short-term trials, treatment guidelines recommend them as third line therapies due to relative lack of long-term safety data, especially for those who have been commercialized recently. Here, we have reviewed the long-term safety data obtained from National Registries, randomized controlled trials, open-label extension studies and meta-analyses on etanercept, infliximab, adalimumab, and ustekinumab in the treatment of adults with moderate to severe plaque psoriasis.

  9. Biological hydrogen production

    Energy Technology Data Exchange (ETDEWEB)

    Benemann, J.R. [Univ. of California, Berkeley, CA (United States)

    1995-11-01

    Biological hydrogen production can be accomplished by either thermochemical (gasification) conversion of woody biomass and agricultural residues or by microbiological processes that yield hydrogen gas from organic wastes or water. Biomass gasification is a well established technology; however, the synthesis gas produced, a mixture of CO and H{sub 2}, requires a shift reaction to convert the CO to H{sub 2}. Microbiological processes can carry out this reaction more efficiently than conventional catalysts, and may be more appropriate for the relatively small-scale of biomass gasification processes. Development of a microbial shift reaction may be a near-term practical application of microbial hydrogen production.

  10. Exports reflect "safety of products"

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    Most of the made-in-China products are absolutely safe, and the steady increase in exports despite the recent widespread criticism reflects their safety standards, a Ministry of Commerce official said Thursday.

  11. Safety and immunogenicity of Onderstepoort Biological Products' Rift Valley fever Clone 13 vaccine in sheep and goats under field conditions in Senegal.

    Science.gov (United States)

    Lo, Modou M; Mbao, Victor; Sierra, Pascale; Thiongane, Yaya; Diop, Mariame; Donadeu, Meritxell; Dungu, Baptiste

    2015-05-29

    This blinded field safety study was conducted in Senegal to assess safety and immunogenicity of administration of the registered dose of Rift Valley fever virus (RVFV) Clone 13 vaccine (Onderstepoort Biological Products) to sheep and goats of West African breeds under natural conditions. A total of 267 small ruminants (220 sheep, 47 goats) were included; half received RVFV Clone 13 vaccine at the recommended dose and half received the diluent (as placebo) only. The study was performed on three commercial farms in the northern and eastern region of Senegal in accordance with veterinary good clinical practices. The animals were observed daily for 3 days after vaccination, and then weekly for 1 year. In both sheep and goats vaccinated against RVFV seroconversion rates above 70% were recorded. No seroconversion related to RVFV was observed in placebo-treated animals. No statistically significant differences were determined between placebo and vaccinated groups for mean rectal temperatures for the first 3 days after administration (p > 0.05). No abnormal clinical signs related to treatment were noted, and only one slight injection site reaction was observed in one vaccinated animal for 2 days after vaccination. Out of 176 births assessed over 1 year (93 from the vaccinated group, 83 from the placebo group), 9 were abnormal in the placebo group and 3 in the vaccinated group (p > 0.05). The frequency of adverse events was similar in the placebo and vaccinated groups. RVFV Clone 13 vaccine administered according to the manufacturer's instructions was safe and well tolerated in West African breeds of sheep and goats, including animals of approximately 6 months of age and pregnant females, under field conditions in Senegal. Antibody levels persisted up to 1 year after vaccination.

  12. Cell biology and EMF safety standards.

    Science.gov (United States)

    Blank, Martin

    2015-01-01

    Living cells react defensively and start to synthesize stress proteins when exposed to potentially harmful stimuli. Electromagnetic fields (EMF) are among the many different environmental stimuli that initiate stress protein synthesis. Although there is greater energy transfer and heating due to EMF at higher frequencies, there is no greater stress response. The cellular stress response is far more sensitive to EMF than to an increase in temperature. It should be obvious that an EMF safety standard should be based on the more sensitive, natural biological response.

  13. Monitoring product safety in the postmarketing environment.

    Science.gov (United States)

    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.

  14. Synthetic Biology Guides Biofuel Production

    Directory of Open Access Journals (Sweden)

    Michael R. Connor

    2010-01-01

    Full Text Available The advancement of microbial processes for the production of renewable liquid fuels has increased with concerns about the current fuel economy. The development of advanced biofuels in particular has risen to address some of the shortcomings of ethanol. These advanced fuels have chemical properties similar to petroleum-based liquid fuels, thus removing the need for engine modification or infrastructure redesign. While the productivity and titers of each of these processes remains to be improved, progress in synthetic biology has provided tools to guide the engineering of these processes through present and future challenges.

  15. Safety in the design of production lines

    DEFF Research Database (Denmark)

    Dyhrberg, Mette Bang; Broberg, Ole; Jacobsen, Peter

    2006-01-01

    This paper is a case study report on how safety considerations were handled in the process of redesigning a production line. The design process was characterized as a specification and negotiation process between engineers from the company and the supplier organization. The new production line...... became safer, but not as a result of any intentional plan to integrate safety aspects into the design process. Instead, the supplier’s design of a new piece of equipment had a higher built-in safety level. The engineering team in the company was aware of the importance of safety aspects neither...... a ‘history workshop’ with the engineering team. The workshop clarified the sequence of events and discussions that took place during the design process and opened for a discussion of the role of safety aspects. During the workshop new insights emerged into the question of how to integrate safety aspects...

  16. Monitoring product safety in the postmarketing environment

    OpenAIRE

    Sharrar, Robert G; 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 dispr...

  17. Biological hydrogen production from phytomass

    Energy Technology Data Exchange (ETDEWEB)

    Bartacek, J.; Zabranska, J. [Inst. of Chemical Technology, Prague (Czech Republic). Dept. of Water Technology and Environmental Engineering

    2004-07-01

    Renewable sources of energy have received wide attention lately. One candidate is hydrogen which has the added advantage of involving no greenhouse gases. Biological hydrogen production from wastewater or biowastes is a very attractive production technique. So far, most studies have concentrated on the use of photosynthetic bacteria. However, dark fermentation has recently become a popular topic of research as it has the advantage of not requiring light energy input, something that limits the performance of the photosynthetic method. While pure cultures have been used in most of the investigations to date, in industrial situations mixed cultures will probably be the norm because of unavoidable contamination. In this investigation the phytomass of amaranth (Amaranthus cruentus L) was used to produce hydrogen. Specific organic loading, organic loading, and pH were varied to study the effect on hydrogen production. 18 refs., 1 tab., 6 figs.

  18. Microbial bioinformatics for food safety and production.

    Science.gov (United States)

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

    2016-03-01

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

  19. 77 FR 30887 - Amendments to Sterility Test Requirements for Biological Products; Correction

    Science.gov (United States)

    2012-05-24

    ... Test Requirements for Biological Products; Correction AGENCY: Food and Drug Administration, HHS. ACTION... manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule...

  20. Current challenges and opportunities in nonclinical safety testing of biologics.

    Science.gov (United States)

    Kronenberg, Sven; Baumann, Andreas; de Haan, Lolke; Hinton, Heather J; Moggs, Jonathan; Theil, Frank-Peter; Wakefield, Ian; Singer, Thomas

    2013-12-01

    Nonclinical safety testing of new biotherapeutic entities represents its own challenges and opportunities in drug development. Hot topics in this field have been discussed recently at the 2nd Annual BioSafe European General Membership Meeting. In this feature article, discussions on the challenges surrounding the use of PEGylated therapeutic proteins, selection of cynomolgus monkey as preclinical species, unexpected pharmacokinetics of biologics and the safety implications thereof are summarized. In addition, new developments in immunosafety testing of biologics, the use of transgenic mouse models and PK and safety implications of multispecific targeting approaches are discussed. Overall, the increasing complexity of new biologic modalities and formats warrants tailor-made nonclinical development strategies and experimental testing.

  1. Safety in the redesigning of production lines

    DEFF Research Database (Denmark)

    Dyhrberg, Mette Bang; Broberg, Ole; Jacobsen, Peter

    2006-01-01

    This paper is a case study report on how safety considerations were handled in the process of redesigning a production line. The design process was characterized as a specification and negotiation process between engineers from the company and the supplier organization. The new production line...

  2. 16 CFR 1115.8 - Compliance with product safety standards.

    Science.gov (United States)

    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...

  3. Biological ensilage of fish - optimization of stability, safety and functionality

    NARCIS (Netherlands)

    Enes Dapkevicius, M.L.N.

    2002-01-01

    This thesis deals with stability, safety, and functionality aspects of biological fish silage (BFS) obtained by lactic acid fermentation. BFS may provide an economically viable, environment friendly way of upgrading fish waste.BFS has been found advantageous when compared to the so-called acid proce

  4. A comparison of the oral application and injection routes using the Onderstepoort Biological Products Fowl Typhoid vaccine, its safety, efficacy and duration of protection in commercial laying hens : article

    Directory of Open Access Journals (Sweden)

    C. Purchase

    2008-05-01

    Full Text Available This study was undertaken to establish whether the Onderstepoort Biological Products Fowl Typhoid (OBPft vaccine registered as an injectable vaccine was effective and safe when administered orally to commercial layers. Its efficacy and duration of protection were compared with application by intramuscular injection. Commercial brown layer hens were used as they were found to be highly susceptible to Salmonella gallinarum infections. In the vaccine safety trial birds were euthanased at timed intervals spanning 4 weeks post-vaccination. Necropsies were performed and samples were taken and tested. No clinical signs or mortalities could be attributed to the OBPft vaccine nor could active shedding of the vaccine strain be detected. Slight pathological changes were noted with both routes of vaccination; however, these changes were transient, returning to normal within the observation period. The injected groups showed a better serological response with the rapid serum plate agglutination (RSPA test than the orally vaccinated groups. In the duration of protection trial, birds were challenged at 3-8-week intervals post-vaccination. All unvaccinated birds died. Protection 8 and 16 weeks after vaccination was above 60 %, by 24 weeks after challenge, the vaccine protection was below 30 %. It was found that there was no significant difference (P < 0.05 in the protection offered by either the oral or injected route of vaccination with the OBPft vaccine.

  5. Intensive swine production and pork safety.

    Science.gov (United States)

    Davies, Peter R

    2011-02-01

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

  6. Parenteral nutrition product shortages: impact on safety.

    Science.gov (United States)

    Holcombe, Beverly

    2012-03-01

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

  7. Biologic Therapy in Inflammatory Immunomediated Systemic Diseases: Safety Profile.

    Science.gov (United States)

    Moroncini, Gianluca; Albani, Lisa; Nobili, Lorenzo; Gabrielli, Armando

    2016-01-01

    The discovery of some key molecular mechanisms underlying the dysregulation of the immune system responsible for inflammatory systemic diseases as severe as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), and Systemic Vasculitides, led to the development and subsequent introduction into clinical practice of biological drugs which are significantly improving the management of such complex disorders. This novel molecular targeted therapeutics represents in fact a valid alternative or complementary treatment to conventional immunosuppressive strategies, characterized by broad, unspecific actions and severe adverse effects. Main advantages of the use of biologic drugs reside in their steroid-sparing effect and in the ability of inducing remission of refractory disease states or curing specific organ involvements. Aim of this article is to review and briefly discuss the scientific evidence supporting the use of biologics in these diseases, with a particular emphasis on their efficacy and safety profile compared to the canonical drugs.

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

    Science.gov (United States)

    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…

  9. 9 CFR 114.4 - Identification of biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Identification of biological products... REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.4 Identification of biological products. Suitable tags or labels of... biological products, all component parts to be combined to form a biological product, all......

  10. Chemical safety of meat and meat products.

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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…

  12. Safety assessment and biological effects of a new cold processed SilEmulsion for dermatological purpose.

    Science.gov (United States)

    Raposo, Sara; Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C; Urbano, Manuela; Ribeiro, Helena M

    2013-01-01

    It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids.

  13. Safety Assessment and Biological Effects of a New Cold Processed SilEmulsion for Dermatological Purpose

    Directory of Open Access Journals (Sweden)

    Sara Raposo

    2013-01-01

    Full Text Available It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion. The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53. EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids.

  14. Design and Realization of the Safety Production Scheduling System

    Directory of Open Access Journals (Sweden)

    Qiang Fan

    2013-01-01

    Full Text Available In this study, we have a research of the design and realization of the Safety Production Scheduling System. Urged by the government departments as well as safety supervising institutions, many coal enterprises are embarking on designing and constructing an information system platform for safety production and scheduling. How to establish a systematic, comprehensive, standardized and scientific management platform for the safety production and scheduling has become a hot issue in the coal industry, which is also an important move to integrate various safety management measures in order to prevent major safety accidents and keep up with the international industry status. Taking a successful, large-scale safety production and scheduling system for example, this study elaborates on its overall design and construction. When the system is completed, it will play an important role in strengthening safety production of the coal mines, preventing accidents as well as increasing the overall safety level of the coal industry.

  15. Safety of treatment with biologics for psoriasis in daily practice: 5-year data.

    NARCIS (Netherlands)

    Lumig, P.P.M. van; Driessen, R.J.B.; Berends, M.A.M.; Boezeman, J.B.M.; Kerkhof, P.C.M. van de; Jong, E.M.G.J. de

    2012-01-01

    BACKGROUND: The cumulative exposition to biologics is increasing with prolonged treatment with a certain biologic or consecutive biological treatment. However, long-term safety data are limited available. OBJECTIVES: The aim of this study was to prospectively evaluate the 5-year safety of biological

  16. Biological production of organic compounds

    Energy Technology Data Exchange (ETDEWEB)

    Yu, Jianping; Paddock, Troy; Carrieri, Damian; Maness, Pin-Ching; Seibert, Michael

    2016-04-12

    Strains of cyanobacteria that produce high levels of alpha ketoglutarate (AKG) and pyruvate are disclosed herein. Methods of culturing these cyanobacteria to produce AKG or pyruvate and recover AKG or pyruvate from the culture are also described herein. Nucleic acid sequences encoding polypeptides that function as ethylene-forming enzymes and their use in the production of ethylene are further disclosed herein. These nucleic acids may be expressed in hosts such as cyanobacteria, which in turn may be cultured to produce ethylene.

  17. Natural production of biological optical systems

    Science.gov (United States)

    Choi, Seung Ho; Kim, Young L.

    2015-03-01

    Synthesis and production in nature often provide ideas to design and fabricate advanced biomimetic photonic materials and structures, leading to excellent physical properties and enhanced performance. In addition, the recognition and utilization of natural or biological substances have been typical routes to develop biocompatible and biodegradable materials for medical applications. In this respect, biological lasers utilizing such biomaterials and biostructures have been received considerable attention, given a variety of implications and potentials for bioimaging, biosensing, implantation, and therapy. However, without relying on industrial facilities, eco-friendly massive production of such optical components or systems has not yet been investigated. We show examples of bioproduction of biological lasers using agriculture and fisheries. We anticipate that such approaches will open new possibilities for scalable eco-friendly `green' production of biological photonics components and systems.

  18. 9 CFR 114.6 - Mixing biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Mixing biological products. 114.6 Section 114.6 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF... BIOLOGICAL PRODUCTS § 114.6 Mixing biological products. Each biological product, when in liquid form,...

  19. Product development of probiotics as biological drugs.

    Science.gov (United States)

    Sutton, Ann

    2008-02-01

    Elements of product and manufacturing-process design are described for product development of live biotherapeutic biological drugs. Product design uses the history and the phenotypic and genotypic characterization of the selected strain. The quality and integrity of the selected strain can be ensured by preservation in a qualified cell-bank system. Manufacturing-process design includes step-by-step description, including the necessary process-input parameters and the expected output results. The active ingredients in the biological drug are usually manufactured using aseptic processing. The manufacture of the final dosage form of live biotherapeutics requires bioburden control or aseptic manufacture, as appropriate. Specifications for live biotherapeutics must comply with regulations for licensed biological products. Evidence of stability for the duration of the shelf life, as well as stability under the recommended conditions of use, must be provided for licensure.

  20. Standardization for natural product synthetic biology.

    Science.gov (United States)

    Zhao, Huimin; Medema, Marnix H

    2016-08-27

    Standardization is one of the foundational features of modern-day engineering, and the use of standardized parts and processes is a key element that distinguishes bona fide synthetic biology from traditional genetic engineering. Here, we discuss the role of standardization in natural product synthetic biology, focusing on standardization of data on biosynthetic pathways and gene clusters, as well as the role of standardization in the process of biosynthetic gene cluster engineering.

  1. 9 CFR 112.6 - Packaging biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Packaging biological products. 112.6... § 112.6 Packaging biological products. (a) Each multiple-dose final container of a biological product... equipment. (e) Final containers of biological product prepared at a licensed establishment, or imported,...

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

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 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? The PSP must include the following: (1) A complete description of the product, including a list of...

  3. Relevance of microbial finished product testing in food safety management

    NARCIS (Netherlands)

    Zwietering, M.H.; Jacxsens, L.; Membre, J.M.; Nauta, M.; Peterz, M.

    2016-01-01

    Management of microbiological food safety is largely based on good design of processes, products and procedures. Finished product testing may be considered as a control measure at the end of the production process. However, testing gives only very limited information on the safety status of a food.

  4. MedWatch Safety Alerts for Human Medical Products

    Data.gov (United States)

    U.S. Department of Health & Human Services — MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts...

  5. 78 FR 57570 - Safety Zone; Motion Picture Production; Chicago, Illinois

    Science.gov (United States)

    2013-09-19

    ... SECURITY Coast Guard 33 CFR Part 165 RIN 1625-AA00 Safety Zone; Motion Picture Production; Chicago... will enforce the temporary safety zone for motion picture filming in Calumet Harbor, Chicago, IL from 9... intended to ensure safety of life on navigable waters during nighttime filming of a motion picture...

  6. 9 CFR 115.2 - Inspections of biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Inspections of biological products... § 115.2 Inspections of biological products. (a) Any biological product, the container of which bears a...) When notified to stop distribution and sale of a serial or subserial of a veterinary biological...

  7. Optimization of Safety Production Supervision Mode of Coalmining Enterprises

    Institute of Scientific and Technical Information of China (English)

    ZHOU Min; XIAO Zhong-hai

    2005-01-01

    In view of the fact that safety production supervision of coal mines in China features low efficacy, this paper applies principles of cybernetics to simulate the dynamic process of safety supervision, and proposes that institutional variables be controlled to support intermediate goals, which in turn contribute to the ultimate safety production objective. Rather than focusing all attention on safety issues of working faces, supervising departments of coalmines are advised to pay much more attention to institutional factors that may impact people's attitude and behavior, which are responsible for most coalmine accidents. It is believed that such a shift of attention can effectively reduce coalmining production accidents and greatly enhance supervision efficacy.

  8. Food Safety Detection Methods Applied to National Special Rectification of Product Quality and Food Safety

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ Afour-month period of national special rectification for product quality and food safety officially started on August 25, and was focused on eight fields, including those of agricultural products and processed foods.

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

    Science.gov (United States)

    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

  10. Relevance of microbial finished product testing in food safety management

    DEFF Research Database (Denmark)

    Zwietering, Marcel H.; Jacxsens, Liesbeth; Membré, Jeanne Marie

    2016-01-01

    -active way by implementing an effective food safety management system. For verification activities in a food safety management system, finished product testing may however be useful. For three cases studies; canned food, chocolate and cooked ham, the relevance of testing both of finished products...

  11. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Science.gov (United States)

    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 PARTICIPATION AND COMMISSION EMPLOYEE INVOLVEMENT IN VOLUNTARY STANDARDS ACTIVITIES General Policies §...

  12. 9 CFR 114.17 - Rebottling of biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Rebottling of biological products. 114.17 Section 114.17 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT... REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.17 Rebottling of biological products. The Administrator...

  13. 9 CFR 114.18 - Reprocessing of biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Reprocessing of biological products. 114.18 Section 114.18 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.18 Reprocessing of biological products. The Administrator...

  14. Analysis on safety production in coal mines Henan Province

    Institute of Scientific and Technical Information of China (English)

    KONG Liu-an; ZHANG Wen-yong

    2006-01-01

    Based on the rigorous situation of safety production in coal mines, the paper analyzed the statistical data of recent accidents indexes in Henan's coal mines. Using investigation and comparison analysis methods, a specified analysis on mining conditions, technical facility level, safety input and vocational quality of workers in Henan's coal mines was conducted. The result indicates that there have been existing such main safety production problems as weak safety management, low-level facilities, inadequate safety input and poor vocational quality and so on. Finally it proposes such reference solutions as to establish and perfect coal mining supervision and management system, to increase safety investment into techniques and facilities and to strengthen workers' safety education and introduction of more high-level professional talents.

  15. Support for the revocation of general safety test regulations in biologics license applications.

    Science.gov (United States)

    Evans, Dana M; Thorn, Jennifer M; Arch-Douglas, Katherine; Sperry, Justin B; Thompson, Bruce; Davis, Heather L; McCluskie, Michael J

    2016-05-01

    The United States Food and Drug Administration recently removed the requirement for a General Safety Test (GST) for biologics in the Code of Federal Regulations (21 CFR 610.11). The GST, as well as abnormal toxicity (European Pharmacopeia) and innocuity tests (World Health Organization), were designed to test for extraneous toxic contaminants on each product lot intended for human use. Tests require one-week observations for general health and weight following injection of specified volumes of product batches into guinea pigs and mice. At the volumes specified, dose-related toxicity may result when the product is pharmacologically active in rodents. With vaccines, required doses may be > 3 logs higher than intended human dose on a weight-adjusted basis and if an immune modulatory adjuvant is included, systemic immune hyperactivation may cause toxicity. Herein, using the CpG/alum adjuvant combination we evaluated the different test protocols and showed their unsuitability for this adjuvant combination.

  16. 9 CFR 103.1 - Preparation of experimental biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Preparation of experimental biological... PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING § 103.1 Preparation of experimental biological products. Except as otherwise provided in this section, experimental...

  17. 9 CFR 113.50 - Ingredients of biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Ingredients of biological products... REQUIREMENTS Ingredient Requirements § 113.50 Ingredients of biological products. All ingredients used in a licensed biological product shall meet accepted standards of purity and quality; shall be...

  18. Systems biology solutions for biochemical production challenges

    DEFF Research Database (Denmark)

    Hansen, Anne Sofie Lærke; Lennen, Rebecca M; Sonnenschein, Nikolaus

    2017-01-01

    There is an urgent need to significantly accelerate the development of microbial cell factories to produce fuels and chemicals from renewable feedstocks in order to facilitate the transition to a biobased society. Methods commonly used within the field of systems biology including omics character......There is an urgent need to significantly accelerate the development of microbial cell factories to produce fuels and chemicals from renewable feedstocks in order to facilitate the transition to a biobased society. Methods commonly used within the field of systems biology including omics...... characterization, genome-scale metabolic modeling, and adaptive laboratory evolution can be readily deployed in metabolic engineering projects. However, high performance strains usually carry tens of genetic modifications and need to operate in challenging environmental conditions. This additional complexity...... compared to basic science research requires pushing systems biology strategies to their limits and often spurs innovative developments that benefit fields outside metabolic engineering. Here we survey recent advanced applications of systems biology methods in engineering microbial production strains...

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

    Science.gov (United States)

    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…

  20. 78 FR 51064 - Safety Zone; Motion Picture Production; Chicago, IL

    Science.gov (United States)

    2013-08-20

    ... SECURITY Coast Guard 33 CFR Part 165 RIN 1625-AA00 Safety Zone; Motion Picture Production; Chicago, IL... from portions of Chicago waterways due to the filming of a motion picture. These temporary safety zones... work, low-flying helicopter, and other hazards involved in the filming of a motion picture. DATES:...

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

    Science.gov (United States)

    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.

  2. Cost Benefit Analysis of Consumer Product Safety Standards

    Science.gov (United States)

    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)

  3. The Current Situation of Quality Supervision and Production Safety of Aquatic Products in Nanjing City

    Institute of Scientific and Technical Information of China (English)

    Guoqin; ZHOU; Wenjie; LI

    2013-01-01

    In recent years, the work of quality supervision and production safety of aquatic products in Nanjing City has been carried out rapidly, and the system of "origin exit, market access, sign traceability, real-time monitoring" has been basically formed, initially realizing the whole-process monitoring on the quality safety of aquatic products from "pond to table". We take the current situation of quality supervision and production safety of aquatic products in Nanjing City as the study object, take the basic work of supervision on aquatic products in Nanjing City and advancing both in scope and in depth as breakthrough point, to sum up the results achieved in the work of quality supervision and production safety of aquatic products in Nanjing City in recent years; make initial exploration and research, in order to consolidate the existing achievements, and further enhance the level of supervision on quality safety of aquatic products in Nanjing City.

  4. Evaluation of Safety, Quality and Productivity in Construction

    Science.gov (United States)

    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.

  5. RESEARCH OF QUALITY, SAFETY AND CONTENT OF BIOLOGICALLY ACTIVE SUBSTANCES OF FOOD RED BEET

    Directory of Open Access Journals (Sweden)

    Gorash E. Y.

    2015-11-01

    Full Text Available The article presents results of research of quality, safety and content of biologically active substances of food red beet roots of Bordo 237 variety, grown in the Krasnodar region in 2014. On the basis of the research carried out it was established, that there are carbohydrates, proteins, organic acids and mineral substances in the food red beet roots of Bordo 237 variety. Food red beet roots are a source of dietary fibers (pectin, protopectin, hemicelluloses and cellulose, possessing antitoxic, antioxidant, radiation protective, cholesterol-lowering and lipid correcting qualities, and also a source of vitamins C, B9 (folic acid and P-active substances, possessing antioxidant properties. Due to high content in food red beet of a complex of microelements – iron, zinc, manganese and copper, and a complex of macro elements – potassium and magnesium, it can be recommended for prophylaxis and treatment of hypertension, atherosclerosis and other diseases of heart and vascular system, and for prophylaxis of iron-deficiency anemia. Thus, the research of quality, safety and content of biologically active substances showed that food red beet roots of Bordo 237 variety are a high quality component ingredient for creation of food products of specialized and functional purpose

  6. Food Safety Practices in the Egg Products Industry.

    Science.gov (United States)

    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.

  7. Systems biology of microbial exopolysaccharides production

    Directory of Open Access Journals (Sweden)

    Ozlem eAtes

    2015-12-01

    Full Text Available Exopolysaccharides (EPS produced by diverse group of microbial systems are rapidly emerging as new and industrially important biomaterials. Due to their unique and complex chemical structures and many interesting physicochemical and rheological properties with novel functionality, the microbial EPSs find wide range of commercial applications in various fields of the economy such as food, feed, packaging, chemical, textile, cosmetics and pharmaceutical industry, agriculture and medicine. EPSs are mainly associated with high-value applications and they have received considerable research attention over recent decades with their biocompatibility, biodegradability, and both environmental and human compatibility. However only a few microbial EPSs have achieved to be used commercially due to their high production costs. The emerging need to overcome economic hurdles and the increasing significance of microbial EPSs in industrial and medical biotechnology call for the elucidation of the interrelations between metabolic pathways and EPS biosynthesis mechanism in order to control and hence enhance its microbial productivity. Moreover a better understanding of biosynthesis mechanism is a significant issue for improvement of product quality and properties and also for the design of novel strains. Therefore a systems-based approach constitutes an important step towards understanding the interplay between metabolism and EPS biosynthesis and further enhances its metabolic performance for industrial application. In this review, primarily the microbial EPSs, their biosynthesis mechanism and important factors for their production will be discussed. After this brief introduction, recent literature on the application of omics technologies and systems biology tools for the improvement of production yields will be critically evaluated. Special focus will be given to EPSs with high market value such as xanthan, levan, pullulan and dextran.

  8. Biological production of ethanol from coal

    Energy Technology Data Exchange (ETDEWEB)

    1992-12-01

    Due to the abundant supply of coal in the United States, significant research efforts have occurred over the past 15 years concerning the conversion of coal to liquid fuels. Researchers at the University of Arkansas have concentrated on a biological approach to coal liquefaction, starting with coal-derived synthesis gas as the raw material. Synthesis gas, a mixture of CO, H[sub 2], CO[sub 2], CH[sub 4] and sulfur gases, is first produced using traditional gasification techniques. The CO, CO[sub 2] and H[sub 2] are then converted to ethanol using a bacterial culture of Clostridium 1jungdahlii. Ethanol is the desired product if the resultant product stream is to be used as a liquid fuel. However, under normal operating conditions, the wild strain'' produces acetate in favor of ethanol in conjunction with growth in a 20:1 molar ratio. Research was performed to determine the conditions necessary to maximize not only the ratio of ethanol to acetate, but also to maximize the concentration of ethanol resulting in the product stream.

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

    Science.gov (United States)

    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.

  10. Direct farm, production base, traceability and food safety in China

    Institute of Scientific and Technical Information of China (English)

    DING Ji-ping; HUANG Ji-kun; JIA Xiang-ping; BAI Jun-fei; Steve Boucher; Michael Carter

    2015-01-01

    With the rapid growth of China’s economy, rising demand for safety food has been accompanied by frequent food safety scandals. Given that China’s farming is dominated by milions of smal-scale farms, ensuring food safety is a major chalenge facing the public and private sectors. The direct farm (DF) program, initiated in 2008, represents one of the government’s major initiatives to modernize the distribution of fresh fruit and vegetables (FFV) and improve food safety. Under the DF program, participating national and international retailers are expected to establish more direct procurement relationships with farm communities. While it is often claimed that greater participation by retailers in the production and post-harvest processing implied the DF program wil lead to improved quality, safety and traceability, systematic evidence remains elu-sive as existing studies are largely narrative, based on case studies, or theoretical inference. Little empirical evidence is available for a broader evaluation of the DF program. This paper aims to ifl this gap by assessing the overal performance of a single retailer’s DF experience with respect to the procurement and food safety of FFV. We use data from a survey of production managers of 35 DF production bases (PBs) spread across 11 provinces, 3 cities and 1 autonomous region in China. The results show a mixture of opportunities and chalenges. On one hand, the DF program improves production practices and distribution channels of FFV produced on its PBs, thus facilitating the move of China’s food system towards improved food safety compliance. On the other hand, signiifcant heterogeneity in the traceability of food and the ability of DF to meet higher safety standards is evident both across major product categories and across household-operatedvs. ifrm-operated PBs. The paper concludes with policy implications.

  11. Danish initiatives to improve the safety of meat products

    DEFF Research Database (Denmark)

    Wegener, Henrik Caspar

    2010-01-01

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

  12. Improving occupational safety and health by integration into product development

    DEFF Research Database (Denmark)

    Broberg, Ole

    1996-01-01

    A cross-sectional case study was performed in a large company producing electro-mechanical products for industrial application. The objectives were: (i) to study the product development process and the role of key actors', (ii) to identify current practice on integrating occupational safety and h...

  13. Monascus secondary metabolites: production and biological activity.

    Science.gov (United States)

    Patakova, Petra

    2013-02-01

    The genus Monascus, comprising nine species, can reproduce either vegetatively with filaments and conidia or sexually by the formation of ascospores. The most well-known species of genus Monascus, namely, M. purpureus, M. ruber and M. pilosus, are often used for rice fermentation to produce red yeast rice, a special product used either for food coloring or as a food supplement with positive effects on human health. The colored appearance (red, orange or yellow) of Monascus-fermented substrates is produced by a mixture of oligoketide pigments that are synthesized by a combination of polyketide and fatty acid synthases. The major pigments consist of pairs of yellow (ankaflavin and monascin), orange (rubropunctatin and monascorubrin) and red (rubropunctamine and monascorubramine) compounds; however, more than 20 other colored products have recently been isolated from fermented rice or culture media. In addition to pigments, a group of monacolin substances and the mycotoxin citrinin can be produced by Monascus. Various non-specific biological activities (antimicrobial, antitumor, immunomodulative and others) of these pigmented compounds are, at least partly, ascribed to their reaction with amino group-containing compounds, i.e. amino acids, proteins or nucleic acids. Monacolins, in the form of β-hydroxy acids, inhibit hydroxymethylglutaryl-coenzyme A reductase, a key enzyme in cholesterol biosynthesis in animals and humans.

  14. Biologically plausible and evidence-based risk intervals in immunization safety research.

    Science.gov (United States)

    Rowhani-Rahbar, Ali; Klein, Nicola P; Dekker, Cornelia L; Edwards, Kathryn M; Marchant, Colin D; Vellozzi, Claudia; Fireman, Bruce; Sejvar, James J; Halsey, Neal A; Baxter, Roger

    2012-12-17

    In immunization safety research, individuals are considered at risk for the development of certain adverse events following immunization (AEFI) within a specific period of time referred to as the risk interval. These intervals should ideally be determined based on biologic plausibility considering features of the AEFI, presumed or known pathologic mechanism, and the vaccine. Misspecification of the length and timing of these intervals may result in introducing bias in epidemiologic and clinical studies of immunization safety. To date, little work has been done to formally assess and determine biologically plausible and evidence-based risk intervals in immunization safety research. In this report, we present a systematic process to define biologically plausible and evidence-based risk interval estimates for two specific AEFIs, febrile seizures and acute disseminated encephalomyelitis. In addition, we review methodologic issues related to the determination of risk intervals for consideration in future studies of immunization safety.

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

    Science.gov (United States)

    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.

  16. Safety and efficacy of personal care products containing colloidal oatmeal

    OpenAIRE

    Criquet M; Roure R; Dayan L; Nollent V; Bertin C

    2012-01-01

    Maryline Criquet,1 Romain Roure,1 Liliane Dayan,2 Virginie Nollent,1 Christiane Bertin11Johnson & Johnson Santé Beauté France, Issy les Moulineaux, 2Independent consultant dermatologist, Paris, FranceBackground: Colloidal oatmeal is a natural ingredient used in the formulation of a range of personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive product in atopic dermatitis. The safety of personal care products used on vu...

  17. Health and safety risks in production agriculture.

    OpenAIRE

    Von Essen, S G; McCurdy, S A

    1998-01-01

    Production agriculture is associated with a variety of occupational illnesses and injuries. Agricultural workers are at higher risk of death or disabling injury than most other workers. Traumatic injury commonly occurs from working with machinery or animals. Respiratory illness and health problems from exposures to farm chemicals are major concerns, and dermatoses, hearing loss, certain cancers, and zoonotic infections are important problems. Innovative means of encouraging safe work practice...

  18. Design of Traceability System for Pork Safety Production

    Institute of Scientific and Technical Information of China (English)

    2009-01-01

    With the development of society and the improvement of living standards,consumers’demand for high quality meat products is constantly increasing.Traceability for livestock products is widely recognized to be an effective measure for any modern and integrated food safety control system.The quality tracing and traceability system of production’s entire processes is an important technology tool to protect pork safety.This paper proposes a RFID-enabled traceability system for pork supply chain.By adopting SQL Server 2000 databases and intelligent identification technology,a tracing system suitable to Chinese situation for monitoring and controlling quality of pork is constructed,and it manages to realize information traceability for entire pork production.The study indicates that the traceability system is valuable for practical reference and feasible.It can help consumers to confide in pork safety and encourage the pork industry developing.

  19. Management present situation and countermeasures of coal mines safety in production

    Institute of Scientific and Technical Information of China (English)

    ZHANG Shu-dong; YU Chang-wu

    2008-01-01

    Analyzed of the present situation of Chinese coal mines safety in production and the reasons for coal mining accident, and realized the coal mines safety in production,which should increase the legal safeguards of coal mine safety in production, and safety input, established the comprehensive coal mine safety evaluation system, comprehensively enhance quality of coal mine workers, established and improved early warning mechanism of safety production of coal mine.

  20. 9 CFR 106.1 - Biological products; exemption.

    Science.gov (United States)

    2010-01-01

    ... Section 106.1 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXEMPTION FOR BIOLOGICAL PRODUCTS USED IN DEPARTMENT PROGRAMS OR UNDER DEPARTMENT CONTROL OR SUPERVISION § 106.1 Biological...

  1. Health and safety risks in production agriculture.

    Science.gov (United States)

    Von Essen, S G; McCurdy, S A

    1998-10-01

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

  2. 30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Science.gov (United States)

    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...

  3. Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling.

    Science.gov (United States)

    Schuck, Robert N; Grillo, Joseph A

    2016-05-01

    Precision medicine promises to improve both the efficacy and safety of therapeutic products by better informing why some patients respond well to a drug, and some experience adverse reactions, while others do not. Pharmacogenomics is a key component of precision medicine and can be utilized to select optimal doses for patients, more precisely identify individuals who will respond to a treatment and avoid serious drug-related toxicities. Since pharmacogenomic biomarker information can help inform drug dosing, efficacy, and safety, pharmacogenomic data are critically reviewed by FDA staff to ensure effective use of pharmacogenomic strategies in drug development and appropriate incorporation into product labels. Pharmacogenomic information may be provided in drug or biological product labeling to inform health care providers about the impact of genotype on response to a drug through description of relevant genomic markers, functional effects of genomic variants, dosing recommendations based on genotype, and other applicable genomic information. The format and content of labeling for biologic drugs will generally follow that of small molecule drugs; however, there are notable differences in pharmacogenomic information that might be considered useful for biologic drugs in comparison to small molecule drugs. Furthermore, the rapid entry of biologic drugs for treatment of rare genetic diseases and molecularly defined subsets of common diseases will likely lead to increased use of pharmacogenomic information in biologic drug labels in the near future. In this review, we outline the general principles of therapeutic product labeling and discuss the utilization of pharmacogenomic information in biologic drug labels.

  4. Biological hydrogen production using a membrane bioreactor.

    Science.gov (United States)

    Oh, Sang-Eun; Iyer, Prabha; Bruns, Mary Ann; Logan, Bruce E

    2004-07-01

    A cross-flow membrane was coupled to a chemostat to create an anaerobic membrane bioreactor (MBR) for biological hydrogen production. The reactor was fed glucose (10,000 mg/L) and inoculated with a soil inoculum heat-treated to kill non-spore-forming methanogens. Hydrogen gas was consistently produced at a concentration of 57-60% in the headspace under all conditions. When operated in chemostat mode (no flow through the membrane) at a hydraulic retention time (HRT) of 3.3 h, 90% of the glucose was removed, producing 2200 mg/L of cells and 500 mL/h of biogas. When operated in MBR mode, the solids retention time (SRT) was increased to SRT = 12 h producing a solids concentration in the reactor of 5800 mg/L. This SRT increased the overall glucose utilization (98%), the biogas production rate (640 mL/h), and the conversion efficiency of glucose-to-hydrogen from 22% (no MBR) to 25% (based on a maximum of 4 mol-H(2)/mol-glucose). When the SRT was increased from 5 h to 48 h, glucose utilization (99%) and biomass concentrations (8,800 +/- 600 mg/L) both increased. However, the biogas production decreased (310 +/- 40 mL/h) and the glucose-to-hydrogen conversion efficiency decreased from 37 +/- 4% to 18 +/- 3%. Sustained permeate flows through the membrane were in the range of 57 to 60 L/m(2) h for three different membrane pore sizes (0.3, 0.5, and 0.8 microm). Most (93.7% to 99.3%) of the membrane resistance was due to internal fouling and the reversible cake resistance, and not the membrane itself. Regular backpulsing was essential for maintaining permeate flux through the membrane. Analysis of DNA sequences using ribosomal intergenic spacer analysis indicated bacteria were most closely related to members of Clostridiaceae and Flexibacteraceae, including Clostridium acidisoli CAC237756 (97%), Linmingia china AF481148 (97%), and Cytophaga sp. MDA2507 AF238333 (99%). No PCR amplification of 16s rRNA genes was obtained when archaea-specific primers were used.

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

    Science.gov (United States)

    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,…

  6. Biological control and sustainable food production

    NARCIS (Netherlands)

    Bale, J.S.; Lenteren, van J.C.; Bigler, F.

    2008-01-01

    The use of biological control for the management of pest insects pre-dates the modern pesticide era. The first major successes in biological control occurred with exotic pests controlled by natural enemy species collected from the country or area of origin of the pest (classical control). Augmentati

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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…

  9. Sustainability, environmental, and safety aspects in the production of biocomposites

    DEFF Research Database (Denmark)

    Markert, Frank

    Future product design requires sustainbale processes and may with great benefit prtially be based on composites made from agricultural by-products. the EU project Biocomp addressed the manufacturing and the parallel assessment of the world wide sustainability of such an approach as well as the en......Future product design requires sustainbale processes and may with great benefit prtially be based on composites made from agricultural by-products. the EU project Biocomp addressed the manufacturing and the parallel assessment of the world wide sustainability of such an approach as well...... as the environmental and safety issues for each of the life cycle phases....

  10. Innovation of Supervision System for Quality and Safety of Edible Agricultural Products

    Institute of Scientific and Technical Information of China (English)

    Xingxing; MEI; Zhongchao; FENG

    2014-01-01

    This paper elaborated multidimensional characteristics of quality and safety of agricultural products,introduced current situation of quality and safety supervision of edible agricultural products in China,analyzed existing problems of quality and safety supervision system and corresponding reasons,and finally came up with recommendations for innovation of supervision system for quality and safety of agricultural products.

  11. A biological safety evaluation on reclaimed water reused as scenic water using a bioassay battery

    Institute of Scientific and Technical Information of China (English)

    Dongbin Wei; Zhuowei Tan; Yuguo Du

    2011-01-01

    An assessment method based on three toxicity tests (algae growth inhibition,daphnia immobilization and larval fish toxicity) was used to screen the biological safety of reclaimed water which was reused as sole replenishment for scenic water system in a park (SOF Park) in northern China.A total of 24 water samples were collected from six sites of water system in the SOF Park in four different seasons.The results indicated that:(1) the reclaimed water directly discharged from a reclamation treatment plant near the SOF Park as influent of park had relatively low biological safety (all samples were ranked as C or D); (2) the biological safety of reclaimed water was improved greatly with the ecological reclamation treatment processes composing of artificial wetland system and followed oxidation pond system; (3) the biological safety of reclaimed water in the main lake of SOF Park kept at a health status during different seasons (all samples were ranked as A); (4) there was some certain correlation (R2 =0.5737) between the sum of toxicity scores and dissolved organic carbon for the studied water samples.It was concluded that the assessment method was reliable to screen the safety of reclaimed water reused as scenic water,and the reclaimed water with further ecological purification processes such as artificial wetland and oxidation pond system can be safely reused as scenic water in park.

  12. Validation of peracetic acid as a sporicide for sterilization of working surfaces in biological safety cabinets

    Directory of Open Access Journals (Sweden)

    Sandra Regina B.R. Sella

    2012-09-01

    Full Text Available Objectives: This study aimed to validate the use of peracetic acid as sporicide agent to decontaminate the workingsurface of a laminar flow biological safety cabinet (BSC, as an alternative to glutaraldehyde, including the selection ofthe disinfecting agent, the method of application, and the contact time.Materials and methods: The test organism was the spore-forming bacterium Bacillus atrophaeus ATCC 9372, which isa surrogate for an important infectious agent. Spore cultures were prepared from B. atrophaeus and used them to testthe sporicidal efficacy of peracetic acid on a BSC stainless steel surface. The performance of the sterilant was assessedby determining minimal inhibitory concentration (MIC and by microbial challenge in conditions that mimicked surfacecontamination. It was used 2.0% glutaraldehyde solution as the control.Results: The range of MICs was 0.6-1.1% for the control and 0.003-0.006% for the 0.2% peracetic acid solution. The 0.2%peracetic acid was an effective sterilant against B. atrophaeus spores (6-7 log spores, under defined conditions of useafter 40 min contact time, which was double that recommended on the product label.Conclusion: It was conclude that while the results of official methods can help to evaluate how products will perform,they are not usually reproducible in real-life user conditions and environments. Validation tests must be carried out toensure the efficacy and safety of surface decontamination procedures. J Microbiol Infect Dis 2012; 2(3: 93-99Key words: Peracetic acid, sporicidal activity, sterility, Bacillus atrophaeus spores, glutaraldehyde

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

    Science.gov (United States)

    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.

  14. The future trends for research on quality and safety of animal products

    Directory of Open Access Journals (Sweden)

    Nigel D. Scollan

    2010-01-01

    Full Text Available Quality must now be considered as a convergence between consumers' wishes and needs and the intrinsic and extrinsic quality attributes of food products. The increasing number of quality attributes which must be considered, increasing globalisation and the heterogeneity in consumption habits between countries are making this convergence progressively more difficult. In parallel, science is rapidly evolving (with the advent of genomics for instance, and a growing number of applications is thus expected for the improvement of food safety and quality. Among the meat and fish quality attributes, colour is very important because it determines, at least in part, consumer choice. The key targets to ensure a satisfactory colour are animal nutrition and management for fish, processing and product conditioning for meat. Tenderness and flavour continue to be important issues for the consumer because eating remains a pleasure. They both determine quality experience which itself influences repetitive purchase. Meat tenderness is a very complex problem which can be solved only by a holistic approach involving all the factors from conception, animal breeding and production, muscle biology and slaughter practice to carcass processing and meat preparation at the consumer end. Today, safety and healthiness are among the most important issues. Unfortunately, animal products can potentially be a source of biological and chemical contamination for consumers. The introduction of both control strategies along the food chain and the development of a food safety management system, from primary production to the domestic environment, are key issues that must be achieved. Despite a high dietary supply of saturated fats by dairy and meat products, it is imperative that professionals involved in animal research and in the associated industry convey the positive nutritional contributions of animal products to both consumers and health professionals. The latter include protein

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  17. Biological safety evaluation of the modified urinary catheter

    Energy Technology Data Exchange (ETDEWEB)

    Kowalczuk, Dorota, E-mail: dorota.kowalczuk@umlub.pl [Department of Medicinal Chemistry, Medical University of Lublin, Jaczewskiego 4, 20-090 Lublin (Poland); Przekora, Agata; Ginalska, Grazyna [Department of Biochemistry and Biotechnology, Medical University of Lublin, Chodzki 1, 20-093 Lublin (Poland)

    2015-04-01

    The purpose of this study was to evaluate in vitro safety of the novel tosufloxacin (TOS)-treated catheters with the prolonged antimicrobial activity. The test samples of silicone latex catheter were prepared by the immobilization of TOS on chitosan (CHIT)-coated catheter by means of covalent bonds and non-covalent interactions. Each step of the modification process of catheter surface was observed using ATR–Fourier transform infrared spectroscopy. In vitro cytotoxicity of the modified and unmodified catheters was assessed by direct and indirect tests in accordance with ISO standards using green monkey kidney (GMK) cell line. The MTT, lactate dehydrogenase activity (LDH), WST-8, Sulforhodamine B (SRB) test results and microscopic observation clearly indicated that unmodified silicone latex catheters decrease cell metabolic activity, act as a cytotoxic agent causing cell lysis and induce cell death through necrotic or apoptotic process. We suggest that chitosan coat with TOS immobilized limits leaching of harmful agents from silicone latex material, which significantly enhances survivability of GMK cells and therefore is quite a good protection against the cytotoxic effect of this material. - Highlights: • Characterization of the novel antimicrobial urinary catheters • Monitoring of the catheter modification by FTIR analysis • Confirmation of high cytotoxicity of latex-based catheter used in urological practice • Chitosan-coated and tosufloxacin-treated catheter is less toxic than the untreated one. • The proposed surface modification protects cells against latex-induced death.

  18. Safety and efficacy of personal care products containing colloidal oatmeal

    Directory of Open Access Journals (Sweden)

    Criquet M

    2012-11-01

    Full Text Available Maryline Criquet,1 Romain Roure,1 Liliane Dayan,2 Virginie Nollent,1 Christiane Bertin11Johnson & Johnson Santé Beauté France, Issy les Moulineaux, 2Independent consultant dermatologist, Paris, FranceBackground: Colloidal oatmeal is a natural ingredient used in the formulation of a range of personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive product in atopic dermatitis. The safety of personal care products used on vulnerable skin is of particular importance and the risk of developing further skin irritations and/or allergies should be minimized.Methods: In a series of studies, we tested the safety of personal care products containing oatmeal (creams, cleansers, lotions by assessing their irritant/allergenic potential on repeat insult patch testing, in safety-in-use and ocular studies using subjects with nonsensitive and sensitive skin. We also tested the skin moisturizing and repair properties of an oatmeal-containing skin care product for dry skin.Results: We found that oatmeal-containing personal care products had very low irritant potential as well as a very low allergenic sensitization potential. Low-level reactions were documented in 1.0% of subjects during the induction phase of repeat insult patch testing; one of 2291 subjects developed a persistent but doubtful low-level reaction involving edema during the challenge phase in repeat insult patch testing. No allergies were reported by 80 subjects after patch testing after in-use application. Sustained skin moisturizing was documented in subjects with dry skin that lasted up to 2 weeks after product discontinuation.Conclusion: Our results demonstrate that colloidal oatmeal is a safe and effective ingredient in personal care products. No allergies were reported by consumers of 445,820 products sold during a 3-year period.Keywords: Avena sativa, colloids, protective agents, atopic dermatitis, irritant dermatitis, allergenic dermatitis, skin

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

    Science.gov (United States)

    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. Packaging Evaluation Approach to Improve Cosmetic Product Safety

    Directory of Open Access Journals (Sweden)

    Benedetta Briasco

    2016-09-01

    Full Text Available In the Regulation 1223/2009, evaluation of packaging has become mandatory to assure cosmetic product safety. In fact, the safety assessment of a cosmetic product can be successfully carried out only if the hazard deriving from the use of the designed packaging for the specific product is correctly evaluated. Despite the law requirement, there is too little information about the chemical-physical characteristics of finished packaging and the possible interactions between formulation and packaging; furthermore, different from food packaging, the cosmetic packaging is not regulated and, to date, appropriate guidelines are still missing. The aim of this work was to propose a practical approach to investigate commercial polymeric containers used in cosmetic field, especially through mechanical properties’ evaluation, from a safety point of view. First of all, it is essential to obtain complete information about raw materials. Subsequently, using an appropriate full factorial experimental design, it is possible to investigate the variables, like polymeric density, treatment, or type of formulation involved in changes to packaging properties or in formulation-packaging interaction. The variation of these properties can greatly affect cosmetic safety. In particular, mechanical properties can be used as an indicator of pack performances and safety. As an example, containers made of two types of polyethylene with different density, low-density polyethylene (LDPE and high-density polyethylene (HDPE, are investigated. Regarding the substances potentially extractable from the packaging, in this work the headspace solid-phase microextraction method (HSSPME was used because this technique was reported in the literature as suitable to detect extractables from the polymeric material here employed.

  1. Chemical Compositional, Biological, and Safety Studies of a Novel Maple Syrup Derived Extract for Nutraceutical Applications

    OpenAIRE

    Zhang, Yan; Yuan, Tao; Li, Liya; Nahar, Pragati; Slitt, Angela; Seeram, Navindra P.

    2014-01-01

    Maple syrup has nutraceutical potential given the macronutrients (carbohydrates, primarily sucrose), micronutrients (minerals and vitamins), and phytochemicals (primarily phenolics) found in this natural sweetener. We conducted compositional (ash, fiber, carbohydrates, minerals, amino acids, organic acids, vitamins, phytochemicals), in vitro biological, and in vivo safety (animal toxicity) studies on maple syrup extracts (MSX-1 and MSX-2) derived from two declassified maple syrup samples. Alo...

  2. National Standard of "General Request on Biological Safety" Was Officially Issued

    Institute of Scientific and Technical Information of China (English)

    2004-01-01

    @@ May 28 2004, sponsored by Standardization Administration of P.R. China ( SAC ) and Certification and Accreditation Administration of P.R. China (CNCA), China National Accreditation Board For Laboratories (CNAL) organized the press conference on National Standard of "General Request on Biological Safety" in Beijing.

  3. Efficacy and safety of biological agents for systemic juvenile idiopathic arthritis

    DEFF Research Database (Denmark)

    Tarp, Simon; Amarilyo, Gil; Foeldvari, Ivan;

    2016-01-01

    % improvement according to the modified American College of Rheumatology Paediatric 30 response criteria (JIA ACR30). The primary safety outcome was defined as serious adverse events (SAEs). Outcomes were analysed by pairwise and network meta-analyses. The quality of evidence between biologic agents...

  4. Safety and efficacy of Labisia pumila containing products

    Directory of Open Access Journals (Sweden)

    Muhammad Syafiq Saleh

    2016-01-01

    Full Text Available Labisia pumila is a traditional medicinal plant which has wide therapeutic application including induction of labor and treatment of dysentery, dysmenorrhea and gonorrhea. We aimed for systematic review of the efficacy andsafety of L. pumila extract or its other commercial products availabe in Malaysian market. The marketed 500 mg capsule is composed of 40 mg L. pumila, 10 mg C. caudatum extract and 450 mg excipient. The commercial products did not follow the registration guidelines of Malaysian National Pharmaceutical Control Bureau (NPCB and advertisement guidelines of Malaysian Advertisement Board. Randomized, placebo controlled clinical trials reported the safe consumpotion of L. pumila water extract on postmanoposal women. Information on the efficacy and safety of commercial products are not sufficiently available. Many unregistered products (mostly capsule form are flooded in Malaysian market without having scientific information. Consumption of those products may seriously impair the health of the people.

  5. 9 CFR 102.5 - U.S. Veterinary Biological Product License.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false U.S. Veterinary Biological Product... BIOLOGICAL PRODUCTS § 102.5 U.S. Veterinary Biological Product License. (a) Authorization to produce each biological product shall be specified on a U.S. Veterinary Biological Product License, issued by...

  6. Emerging patient safety issues under health care reform: follow-on biologics and immunogenicity

    Directory of Open Access Journals (Sweden)

    Liang BA

    2011-12-01

    Full Text Available Bryan A Liang1-3, Timothy Mackey1,41Institute of Health Law Studies, California Western School of Law, 2Department of Anesthesiology, University of California, San Diego School of Medicine, 3San Diego Center for Patient Safety, University of California, San Diego School of Medicine,4Joint Program in Global Health, University of California San Diego-San Diego State University, San Diego, CA, USAAbstract: US health care reform includes an abbreviated pathway for follow-on biologics, also known as biosimilars, in an effort to speed up access to these complex therapeutics. However, a key patient safety challenge emerges from such an abbreviated pathway: immunogenicity reactions. Yet immunogenicity is notoriously difficult to predict, and even cooperative approaches in licensing between companies have resulted in patient safety concerns, injury, and death. Because approval pathways for follow-on forms do not involve cooperative disclosure of methods and manufacturing processes by innovator companies and follow-on manufacturers, the potential for expanded immunogenicity must be taken into account from a risk management and patient safety perspective. The US Institute of Safe Medication Practices (ISMP has principles of medication safety that have been applied in the past to high-risk drugs. We propose adapting ISMP principles to follow-on biologic forms and creating systems approaches to warn, rapidly identify, and alert providers regarding this emerging patient safety risk. This type of system can be built upon and provide lessons learned as these new drug forms are developed and marketed more broadly.Keywords: biosimilars, follow-on biologics, immunogenicity, patient safety, law, health care reform

  7. Production and consumption of biological particles in temperate tidal estuaries

    NARCIS (Netherlands)

    Heip, C.H.R.; Goosen, N.K.; Herman, P.M.J.; Kromkamp, J.C.; Middelburg, J.J.; Soetaert, K.E.R.

    1995-01-01

    The question is reviewed whether a balance exists between production and consumption of biological particles in temperate tidal estuaries and what the relationships are between the magnitude of production and consumption processes and system carbon metabolism. The production terms considered are pri

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

    Science.gov (United States)

    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.

  9. Validation of cross-contamination control in biological safety cabinet for biotech/pharmaceutical manufacturing process.

    Science.gov (United States)

    Hu, Shih-Cheng; Shiue, Angus; Tu, Jin-Xin; Liu, Han-Yang; Chiu, Rong-Ben

    2015-12-01

    For class II, type A2 biological safety cabinets (BSC), NSF/ANSI Standard 49 should be conformed in cabinet airflow velocity derivation, particle contamination, and aerodynamic flow properties. However, there exists a potential problem. It has been built that the cabinet air flow stabilize is influenced by the quantity of downflow of air and the height above the cabinet exhaust opening. Three air downflow quantities were compared as an operating apparatus was placed from 20 to 40 cm above the bench of the cabinet. The results show that the BSC air downflow velocity is a function of increased sampling height, displaying that containment is improvingly permitted over product protection as the sampling height decreases. This study investigated the concentration gradient of particles at various heights and downflow air quantity from the bench of the BSC. Experiment results indicate that performance near the bench was better than in the rest of the BSC. In terms of height, the best cleanliness was measured at a height of 10 cm over the bench; it reduced actually with add in height. The empirical curves accommodate, founded on the concentration gradient of particle created was elaborated for evaluating the particle concentration at different heights and downflow air quantity from the source of the bench of the BSC. The particle image velocimetry system applied for BSC airflow research to fix amount of airflow patterns and air distribution measurement and results of measurements show how obstructions can greatly influence the airflow and contaminant transportation in a BSC.

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

    Science.gov (United States)

    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.

  11. Biological hydrogen production from industrial wastewaters

    Energy Technology Data Exchange (ETDEWEB)

    Peixoto, Guilherme; Pantoja Filho, Jorge Luis Rodrigues; Zaiat, Marcelo [Universidade de Sao Paulo (EESC/USP), Sao Carlos, SP (Brazil). School of Engineering. Dept. Hydraulics and Sanitation], Email: peixoto@sc.usp.br

    2010-07-01

    This research evaluates the potential for producing hydrogen in anaerobic reactors using industrial wastewaters (glycerol from bio diesel production, wastewater from the parboilization of rice, and vinasse from ethanol production). In a complementary experiment the soluble products formed during hydrogen production were evaluated for methane generation. The assays were performed in batch reactors with 2 liters volume, and sucrose was used as a control substrate. The acidogenic inoculum was taken from a packed-bed reactor used to produce hydrogen from a sucrose-based synthetic substrate. The methanogenic inoculum was taken from an upflow anaerobic sludge blanket reactor treating poultry slaughterhouse wastewater. Hydrogen was produced from rice parboilization wastewater (24.27 ml H{sub 2} g{sup -1} COD) vinasse (22.75 ml H{sub 2} g{sup -1} COD) and sucrose (25.60 ml H{sub 2} g{sup -1} COD), while glycerol only showed potential for methane generation. (author)

  12. Biocomes: new biological products for sustainable farming and forestry

    NARCIS (Netherlands)

    Teixidó, N.; Cal, de A.L.; Usall, J.; Guijarro, B.; Larena, I.; Torres, R.; Abadias, M.; Köhl, J.

    2016-01-01

    Abstract:
    The growing interest in biological control has been reflected during last decades in a big number of scientific publications, books and symposia. However, biocontrol commercial application at a European level is limited and biological control products are not currently available for

  13. Cholesterol oxidation products and their biological importance

    DEFF Research Database (Denmark)

    Kulig, Waldemar; Cwiklik, Lukasz; Jurkiewicz, Piotr

    2016-01-01

    The main biological cause of oxysterols is the oxidation of cholesterol. They differ from cholesterol by the presence of additional polar groups that are typically hydroxyl, keto, hydroperoxy, epoxy, or carboxyl moieties. Under typical conditions, oxysterol concentration is maintained at a very low...... and precisely regulated level, with an excess of cholesterol. Like cholesterol, many oxysterols are hydrophobic and hence confined to cell membranes. However, small chemical differences between the sterols can significantly affect how they interact with other membrane components, and this in turn can have...

  14. Production of hydrogen using an anaerobic biological process

    Energy Technology Data Exchange (ETDEWEB)

    Kramer, Robert; Pelter, Libbie S.; Patterson, John A.

    2016-11-29

    Various embodiments of the present invention pertain to methods for biological production of hydrogen. More specifically, embodiments of the present invention pertain to a modular energy system and related methods for producing hydrogen using organic waste as a feed stock.

  15. Total synthesis and biological activity of natural product Urukthapelstatin A.

    Science.gov (United States)

    Lin, Chun-Chieh; Tantisantisom, Worawan; McAlpine, Shelli R

    2013-07-19

    Herein we report the first total synthesis of the natural product Urkuthaplestatin A (Ustat A) utilizing a convergent synthetic strategy. The characterization and biological activity match those of the previously published natural product. Interestingly, several intermediates, including the linear and serine cyclized precursors, show a 100-fold decrease in cytotoxicity, with IC50's in the low micromolar range. These data indicate that the rigidity and the consecutive aromatic heterocyclic system are responsible for the biological activity.

  16. Recent Developments in Biological Hydrogen Production Processes

    Directory of Open Access Journals (Sweden)

    DEBABRATA DAS

    2008-07-01

    Full Text Available Biohydrogen production technology can utilize renewable energy sources like biomass for the generation of hydrogen, the cleanest form of energy for the use of mankind. However, major constraints to the commercialization of these processes include lower hydrogen yields and rates of hydrogen production. To overcome these bottlenecks intensive research work has already been carried out on the advancement of these processes such as the development of genetically modified microorganisms, the improvement of the bioreactor design, molecular engineering of the key enzyme hydrogenases, the development of two stage processes, etc. The present paper explores the recent advancements that have been made till date and also presents the state of the art in molecular strategies to improve the hydrogen production.

  17. European legal developments in product liability and product safety and the Total Quality Management approach

    NARCIS (Netherlands)

    Brack, A.; Gieskes, J.F.B.

    1990-01-01

    The purpose of this paper is to show that Product Liability (PL) and Product Safety (PS) are relevant categories in terms of the Total Quality Management literature. From a societal point of view PL and PS are two sides of a coin. The effects of the PL and PS regulation on companies are described an

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

    Science.gov (United States)

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

    2014-07-02

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

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

    Science.gov (United States)

    Knight, Derek J; Breheny, Damien

    2002-01-01

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

  20. 75 FR 18825 - Advantage Electronic Product Development Incorporated/Utility Crew Safety LLC

    Science.gov (United States)

    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...

  1. 30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

    Science.gov (United States)

    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...

  2. Electricity-mediated biological hydrogen production

    NARCIS (Netherlands)

    Geelhoed, J.S.; Hamelers, H.V.M.; Stams, A.J.M.

    2010-01-01

    Anaerobic bacteria have the ability to produce electricity from the oxidation of organic substrates. They also may use electricity to support chemical reactions that are energetically unfavorable. In the fermentation of sugars, hydrogen can be formed as one of the main products. However, a yield of

  3. Synthetic biological approaches to natural product biosynthesis.

    Science.gov (United States)

    Winter, Jaclyn M; Tang, Yi

    2012-10-01

    Small molecules produced in Nature possess exquisite chemical diversity and continue to be an inspiration for the development of new therapeutic agents. In their host organisms, natural products are assembled and modified using dedicated biosynthetic pathways. By rationally reprogramming and manipulating these pathways, unnatural metabolites containing enhanced structural features that were otherwise inaccessible can be obtained. Additionally, new chemical entities can be synthesized by developing the enzymes that carry out these complicated chemical reactions into biocatalysts. In this review, we will discuss a variety of combinatorial biosynthetic strategies, their technical challenges, and highlight some recent (since 2007) examples of rationally designed metabolites, as well as platforms that have been established for the production and modification of clinically important pharmaceutical compounds.

  4. A review on safety and efficacy of products containing Longifolia

    Directory of Open Access Journals (Sweden)

    Abdul Hafeez Ahmad Hamdi

    2016-01-01

    Full Text Available Eurycoma longifolia (commonly called tongkat ali is a flowering plant in the family Simaroubaceae, native to Indonesia, Malaysia, and, to a lesser extent, Thailand, Vietnam and also Laos. The roots extract of E. longifolia, is a well-known traditional herbal medicine in Asia used for many purposes such as sexual dysfunction, aging, malaria, cancer, diabetes, anxiety, aches, constipation, exercise recovery, fever, increased energy, increased strength, leukemia, osteoporosis, stress, syphilis and glandular swelling. The roots are also used as an aphrodisiac, antibiotic, appetite stimulant and health supplement. It is very important to conserve this valuable medicinal plant for the health benefit of future generations. The purpose of this review article is to evaluate and summarize the existing literatures regarding the efficacy and safety of products which contain E. longifolia as its main ingredient. In summary, based on the literature evaluated in this review article, products which contain tongkat ali showed a clinical benefit on improving erectile dysfunction as well as a good safety profile. We recommend consumers to check the level of the bioactive compound “eurycomanone” as their guide before choosing any E. longifolia product.

  5. BIOLOGICALLY ACTIVE SUBSTANCES OF SPIRIT PRODUCTION WASTE

    Directory of Open Access Journals (Sweden)

    A. S. Kayshev

    2014-01-01

    Full Text Available A content of biologically active compounds (BAC with signified pharmacological activity in distillers grains was proved. It is prospective for applications of these grains as a raw material resource of pharmaceuticals. A composition of BAC distillers grains received from wheat, corn, barley, millet at different spirit enterprises which use hydro fermentative grain processing. Considering polydispersity of distillers grains they were separated on solid and liquid phases preliminary. Physical and chemical characteristics of distillers grains' liquid base were identified. Elementary composition of distillers grains is signified by active accumulation of biogenic elements (phosphorus, potassium, magnesium, calcium, sodium, iron and low content of heavy metals. The solid phase of distillers grains accumulates carbon, hydrogen and nitrogen in high concentration. The liquid phase of distillers grains contains: proteins and amino acids (20-46%, reducing sugars (5,6%-17,5%, galacturonides (0,8-1,4%, ascorbic acid (6,2-11,4 mg%. The solid base of distillers grains contains: galacturonides (3,4-5,3%, fatty oil (8,4-11,1% with predomination of essential fatty acids, proteins and amino acids (2,1-2,5%, flavonoids (0,4-0,9%, tocopherols (3,4-7,7 mg%. A method of complex processing of distillers grains based on application of membrane filtering of liquid phase and liquid extraction by inorganic and organic solvents of solid phase, which allows almost full extraction of the sum of biologically active compounds (BAC from liquid phase (Biobardin BM and solid phase (Biobardin UL. Biobardin BM comprises the following elements: proteins and amino acids (41-69%, reducing sugars (3,5-15,6%, fatty oil (0,2-0,3%, flavonoids (0,2-0,7%, ascorbic acid (17-37 mg%. Biobardin UL includes: oligouronids (16,4-19,5%, proteins and amino acids (11-21%, fatty oil (3,2-4,9% which includes essential acids; flavonoids (0,6-1,5%, tocopherols (6,6-10,2 mg%, carotinoids (0,13-0,21 mg

  6. Role of natural product diversity in chemical biology.

    Science.gov (United States)

    Hong, Jiyong

    2011-06-01

    Through the natural selection process, natural products possess a unique and vast chemical diversity and have been evolved for optimal interactions with biological macromolecules. Owing to their diversity, target affinity, and specificity, natural products have demonstrated enormous potential as modulators of biomolecular function, been an essential source for drug discovery, and provided design principles for combinatorial library development.

  7. 9 CFR 113.3 - Sampling of biological products.

    Science.gov (United States)

    2010-01-01

    ... nonviral Master Seeds requiring cell culture propagation. For Master Seeds isolated or passed in a cell... additional species. For Master Seeds grown in cell culture and intended for use in more than one species, an... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Sampling of biological products....

  8. [Biological safety of nanomaterials: the opportunity and challenge of preventive medicine].

    Science.gov (United States)

    Zhao, Yuliang

    2015-09-01

    Nanotechnology, as a newly arisen technology, does not only benefit people, but also become one of the inevitable threats to public health due to the widely application of nanomaterials. The safety evaluation of nanomaterials has become one of the hottest research topics in the 21st century, which provides opportunities and challenges in the field of preventive medicine once in a blue moon. Although the history of development in the safety assessment of nanomaterials is just over twenty years, the achievements could not be underestimated. This paper summarized the research of nano biological, predicted the directions for future research, and proposed several recommendations, based on which, we hope it can promote the sustainable development safety in China.

  9. Theoretical Application of Supervision over Quality and Safety of Agricultural Products

    Institute of Scientific and Technical Information of China (English)

    Xin; CHENG; Ying; ZHANG

    2013-01-01

    Supervision over quality and safety of agricultural products has received high attention of management department.Competent authorities have formulated and issued many measures to strengthen supervision over quality and safety of agricultural products and improve China’s agricultural product quality and safety level.From the perspective of management science,this paper elaborates basic contents of two basic management theories,Broken Windows Effect and Effect of Heat Furnace.Then,it analyzes influence of Broken Windows Effect and Effect of Heat Furnace on supervision over quality and safety of agricultural products.Finally,it comes up with recommendations for supervision over quality and safety of agricultural products.

  10. The TESS database. Use in product safety assessment.

    Science.gov (United States)

    Litovitz, T

    1998-01-01

    The Toxic Exposure Surveillance System or TESS is a comprehensive poisoning surveillance database maintained by the American Association of Poison Control Centers. It now includes data on more than 20.3 million human poison exposures reported to US poison centres. TESS data are submitted by 67 of the 75 US poison control centres, covering 87% of the US population. Reports to US poison centres included in TESS originate both from the general public and from health professionals (12.9%) and include both patients managed at home or at the site of the exposure (73.6%) and those managed in hospitals, emergency departments, or other healthcare facilities (22.8%). TESS data are used by the pharmaceutical industry to monitor or defend product safety, by regulatory agencies proposing new regulations or considering new approvals or over-the-counter switches, and by clinical researchers attempting to characterise toxicity profiles or determine treatment protocols. TESS is a key component of an effective post-marketing surveillance programme, allowing early identification of previously unsuspected hazards, and early changes in formulations, labelling, or packaging when needed, thereby minimising injuries, deaths and product liability. Deaths, severe outcomes and comparisons of poisoning outcomes and hospitalisation rates between products or product categories are used to identify safety outliers. TESS data for each case of poisoning include identification of the substances implicated (including brand and formulation where known), patient age, outcome, specific clinical effects, exposure route, reason for the exposure (unintentional, suicidal, therapeutic error, etc.), antidotes used and the level of healthcare intervention utilised. Pharmaceuticals are implicated in 42% of TESS poisoning cases. About 53% of all cases of poisoning occur in children under 6 years of age. Of the more than 2.1 million cases reported to TESS in 1996, 123,095 (5.7%) were therapeutic errors and 32

  11. Hydrogen production by biological processes: a survey of literature

    Energy Technology Data Exchange (ETDEWEB)

    Das, Debabrata [Indian Inst. of Technology, Dept. of Biotechnology, Kharagpur (India); Miami Univ., Clean Energy Research Inst., Coral Gables, FL (United States); Veziroglu, T. Nejat [Miami Univ., Clean Energy Research Inst., Coral Gables, FL (United States)

    2001-07-01

    Hydrogen is the fuel of the future mainly due to its high conversion efficiency, recyclability and nonpolluting nature. Biological hydrogen production processes are found to be more environment friendly and less energy intensive as compared to thermochemical and electrochemical processes. They are mostly controlled by either photosynthetic or fermentative organisms. Till today, more emphasis has been given on the former processes. Nitrogenase and hydrogenase play very important roles. Genetic manipulation of cyanobacteria (hydrogenase negative gene) improves the hydrogen generation. The paper presents a survey of biological hydrogen production processes. The micro-organism and biochemical pathways involved in hydrogen generation processes are presented in some detail. Several developmental works are discussed. Immobilised system is found suitable for the continuous hydrogen production. About 28% of energy can be recovered in the form of hydrogen using sucrose as substrate. Fermentative hydrogen production processes have some edge over the other biological processes. (Author)

  12. The Interstellar Production of Biologically Important Organics

    Science.gov (United States)

    Sandford, Scott A.; Bernstein, Max P.; Dworkin, Jason; Allamandola, Louis J.

    2000-01-01

    One of the primary tasks of the Astrochemistry Laboratory at Ames Research Center is to use laboratory simulations to study the chemical processes that occur in dense interstellar clouds. Since new stars are formed in these clouds, their materials may be responsible for the delivery of organics to new habitable planets and may play important roles in the origin of life. These clouds are extremely cold (less than 50 kelvin), and most of the volatiles in these clouds are condensed onto dust grains as thin ice mantles. These ices are exposed to cosmic rays and ultraviolet (UV) photons that break chemical bonds and result in the production of complex molecules when the ices are warmed (as they would be when incorporated into a star-forming region). Using cryovacuum systems and UV lamps, this study simulates the conditions of these clouds and studies the resulting chemistry. Some of the areas of progress made in 1999 are described below. It shows some of the types of molecules that may be formed in the interstellar medium. Laboratory simulations have already confirmed that many of these compounds are made under these conditions.

  13. The Biological Safety of Stainless Steel Needles Used in Warm-Needling

    Directory of Open Access Journals (Sweden)

    Sabina Lim

    2010-01-01

    Full Text Available Warm-needling (also called thermo-acupuncture is a combination of acupuncture and moxibustion. Due to the intense heat involved, there have been concerns over the biological safety of the acuneedles used in the treatment. This paper reports two phases of a safety test. For a preliminary test, we compared the temperature change patterns of stainless steel (SS304 needles and traditional gold alloy needles, which have been increasingly replaced by the former. To verify the effects of the presence of coating materials, the main test involved three different kinds of SS304: silicone-coated, salicylic acid-coated and non-coated needles. Each group of needles was tested for pH level, heavy metals and UV absorbance spectrum along with biological tests on the cytotoxicity and hemolysis of the needle. All the tests on the extractants from the needles were negative. In the biological tests, each test result showed a significant difference from the positive control samples, while no significant difference was observed compared with the negative control samples. In the hemolysis tests, all samples satisfied the Korean Government Standards. All the results suggest that SS304 needles are biologically safe to be used in warm-needling, though they can be improved to perform as well as the gold alloy needles in terms of temperature fluctuations.

  14. 77 FR 22602 - Information Collection Activities: Well Control and Production Safety Training, Submitted for...

    Science.gov (United States)

    2012-04-16

    ... paperwork requirements in the regulations under Subpart O, ``Well Control and Production Safety Training... Control and Production Safety Training. OMB Control Number: 1014-0008. Abstract: The Outer Continental... Bureau of Safety and Environmental Enforcement (BSEE) Information Collection Activities: Well Control...

  15. MILK KEFIR: COMPOSITION, MICROBIAL CULTURES, BIOLOGICAL ACTIVITIES AND RELATED PRODUCTS

    Directory of Open Access Journals (Sweden)

    Maria Rosa Prado

    2015-10-01

    Full Text Available In recent years, there has been a strong focus on beneficial foods with probiotic microorganisms and functional organic substances. In this context, there is an increasing interest in the commercial use of kefir, since it can be marketed as a natural beverage that has health promoting bacteria. There are numerous commercially available kefir based-products. Kefir may act as a matrix in the effective delivery of probiotic microorganisms in different types of products. Also, the presence of kefir’s exopolysaccharides, known as kefiran, which has biological activity, certainly adds value to products. Kefiran can also be used separately in other food products and as a coating film for various food and pharmaceutical products. This article aims to update the information about kefir and its microbiological composition, biological activity of the kefir’s microflora and the importance of kefiran as a beneficial health substance.

  16. Assessment of biological Hydrogen production processes: A review

    Science.gov (United States)

    Najafpour, G. D.; Shahavi, M. H.; Neshat, S. A.

    2016-06-01

    Energy crisis created a special attention on renewable energy sources. Among these sources; hydrogen through biological processes is well-known as the most suitable and renewable energy sources. In terms of process yield, hydrogen production from various sources was evaluated. A summary of microorganisms as potential hydrogen producers discussed along with advantages and disadvantages of several bioprocesses. The pathway of photo-synthetic and dark fermentative organisms was discussed. In fact, the active enzymes involved in performance of biological processes for hydrogen generation were identified and their special functionalities were discussed. The influential factors affecting on hydrogen production were known as enzymes assisting liberation specific enzymes such as nitrogenase, hydrogenase and uptake hydrogenase. These enzymes were quite effective in reduction of proton and form active molecular hydrogen. Several types of photosynthetic systems were evaluated with intension of maximum hydrogen productivities. In addition dark fermentative and light intensities on hydrogen productions were evaluated. The hydrogen productivities of efficient hydrogen producing strains were evaluated.

  17. Combining biologic and phototherapy treatments for psoriasis: safety, efficacy, and patient acceptability

    Directory of Open Access Journals (Sweden)

    Farahnik B

    2016-07-01

    Full Text Available Benjamin Farahnik,1 Viraat Patel,2 Kourosh Beroukhim,3 Tian Hao Zhu,4 Michael Abrouk,2 Mio Nakamura,5 Rasnik Singh,3 Kristina Lee,5 Tina Bhutani,5 John Koo5 1University of Vermont College of Medicine, Burlington, VT; 2School of Medicine, University of California, Irvine, 3David Geffen School of Medicine, University of California, Los Angeles, 4University of Southern California Keck School of Medicine, Los Angeles, 5Department of Dermatology, Psoriasis and Skin Treatment Center, University of California, San Francisco, CA, USA Background: The efficacy and safety of biologic and phototherapy in treating moderate-to-severe psoriasis is well known. However, some patients may not respond well to biologic agents or phototherapy on their own and may require combination therapy. Skillfully combining a biologic agent and phototherapy may provide an additive improvement without much increase in risks.Objective: To summarize the current state of evidence for the efficacy and safety of combining biologics with phototherapy in the treatment of moderate-to-severe plaque psoriasis.Methods: We conducted an extensive search on Pubmed database for English language literature that evaluated the use of a combination of biologic and phototherapy for the treatment of moderate-to-severe psoriasis through January 2016. The search included the following keywords: psoriasis, etanercept, adalimumab, infliximab, ustekinumab, biologics, phototherapy, and combination therapy.Results: The primary literature included randomized controlled trials, a head-to-head study, open-label controlled and uncontrolled trials, case series, and case reports. Etanercept was used in over half of the reported cases, but other biologic agents used included ustekinumab, adalimumab, and infliximab. The vast majority of phototherapy was narrowband ultraviolet B (NBUVB radiation. Most cases reported enhanced improvement with combination therapy. Serious adverse events throughout the study duration

  18. Workshop on Indian Chemical Industry: perspectives on safety, cleaner production and environment production

    NARCIS (Netherlands)

    Ham, J.M.

    1996-01-01

    A Workshop on "Indian Chemical Industry: Perspectives on Safety, Cleaner Production and Environmental Protection" was held on 3, 4 and 5 January 1996, in Bombay, India. The main objective of the workshop, which was organised jointly by the Government of India, UNIDO/UNDP and the Indian Chemical Manu

  19. Natural product synthesis at the interface of chemistry and biology.

    Science.gov (United States)

    Hong, Jiyong

    2014-08-11

    Nature has evolved to produce unique and diverse natural products that possess high target affinity and specificity. Natural products have been the richest sources for novel modulators of biomolecular function. Since the chemical synthesis of urea by Wöhler, organic chemists have been intrigued by natural products, leading to the evolution of the field of natural product synthesis over the past two centuries. Natural product synthesis has enabled natural products to play an essential role in drug discovery and chemical biology. With the introduction of novel, innovative concepts and strategies for synthetic efficiency, natural product synthesis in the 21st century is well poised to address the challenges and complexities faced by natural product chemistry and will remain essential to progress in biomedical sciences.

  20. Do biological medicinal products pose a risk to the environment?: a current view on ecopharmacovigilance.

    Science.gov (United States)

    Kühler, Thomas C; Andersson, Mikael; Carlin, Gunnar; Johnsson, Ann; Akerblom, Lennart

    2009-01-01

    The occurrence of active pharmaceutical substances in the environment is of growing concern. The vast majority of the compounds in question are of low molecular weight, intended for oral use and designed to tolerate, for example, the digestive enzymes in the upper alimentary tract, the harsh milieus found in the acidic stomach, or the microbe rich intestine. Accordingly, these xenobiotic compounds may, due to their inherent biological activity, constitute a risk to the environment. Biological medicinal products, for example recombinant human insulin or monoclonal antibodies, however, are different. They are primarily made up of oligomers or polymers of amino acids, sugars or nucleotides and are thus readily metabolized. They are therefore generally not considered to pose any risk to the environment. Certain classes of biological medicinal products, however, are associated with specific safety issues. Genetically modified organisms as vectors in vaccines or in gene therapy products have attracted much attention in this regard. Issues include the degree of attenuation of the live recombinant vaccine, replication restrictions of the vaccine vector, alteration of the host and tissue tropism of the vector, the possibility of reversion to virulence, and risk to the ecosystem. In this review we discuss the fate and the potential environmental impact of biological medicinal products following clinical use from an ecopharmacovigilance point of view, and review relevant policy documents and regulatory statements.

  1. Research on coal mine safety production management decision system based on VB

    Institute of Scientific and Technical Information of China (English)

    ZHAO Zhong-ling; FENG Xi-wen; FANG Heng-fu; YUAN Qing-he

    2007-01-01

    Based on safety management appraisal theory, the decision system was divided into 5 function menu module, including system control module, mining coal and the tunneling working surface security evaluation module, the entire ore safety production condition appraisal module, the safety management level appraisal module of main production work area, the withdrawal system module and so on. The system operates through the constitutive procedure, outputs the main operation results by graph and form,and realizes the main function of safety evaluation.

  2. The structural biology of enzymes involved in natural product glycosylation.

    Science.gov (United States)

    Singh, Shanteri; Phillips, George N; Thorson, Jon S

    2012-10-01

    The glycosylation of microbial natural products often dramatically influences the biological and/or pharmacological activities of the parental metabolite. Over the past decade, crystal structures of several enzymes involved in the biosynthesis and attachment of novel sugars found appended to natural products have emerged. In many cases, these studies have paved the way to a better understanding of the corresponding enzyme mechanism of action and have served as a starting point for engineering variant enzymes to facilitate to production of differentially-glycosylated natural products. This review specifically summarizes the structural studies of bacterial enzymes involved in biosynthesis of novel sugar nucleotides.

  3. Westinghouse independent safety review of Savannah River production reactors

    Energy Technology Data Exchange (ETDEWEB)

    Leggett, W.D.; McShane, W.J. (Westinghouse Hanford Co., Richland, WA (USA)); Liparulo, N.J.; McAdoo, J.D.; Strawbridge, L.E. (Westinghouse Electric Corp., Pittsburgh, PA (USA). Nuclear and Advanced Technology Div.); Toto, G. (Westinghouse Electric Corp., Pittsburgh, PA (USA). Nuclear Services Div.); Fauske, H.K. (Fauske and Associates, Inc., Burr Ridge, IL (USA)); 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.

  4. Biological hydrogen production by moderately thermophilic anaerobic bacteria

    Energy Technology Data Exchange (ETDEWEB)

    HP Goorissen; AJM Stams [Laboratory of Microbiology, Wageningen University and Research centre Wageningen (Netherlands)

    2006-07-01

    This study focuses on the biological production of hydrogen at moderate temperatures (65-75 C) by anaerobic bacteria. A survey was made to select the best (moderate) thermophiles for hydrogen production from cellulolytic biomass. From this survey we selected Caldicellulosiruptor saccharolyticus (a gram-positive bacterium) and Thermotoga elfii (a gram-negative bacterium) as potential candidates for biological hydrogen production on mixtures of C{sub 5}-C{sub 6} sugars. Xylose and glucose were used as model substrates to describe growth and hydrogen production from hydrolyzed biomass. Mixed substrate utilization in batch cultures revealed differences in the sequence of substrate consumption and in catabolites repression of the two microorganisms. The regulatory mechanisms of catabolites repression in these microorganisms are not known yet. (authors)

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

    Science.gov (United States)

    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).

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

    Directory of Open Access Journals (Sweden)

    James A. Williams

    2013-06-01

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

  7. Continuous downstream processing for high value biological products: A Review.

    Science.gov (United States)

    Zydney, Andrew L

    2016-03-01

    There is growing interest in the possibility of developing truly continuous processes for the large-scale production of high value biological products. Continuous processing has the potential to provide significant reductions in cost and facility size while improving product quality and facilitating the design of flexible multi-product manufacturing facilities. This paper reviews the current state-of-the-art in separations technology suitable for continuous downstream bioprocessing, focusing on unit operations that would be most appropriate for the production of secreted proteins like monoclonal antibodies. This includes cell separation/recycle from the perfusion bioreactor, initial product recovery (capture), product purification (polishing), and formulation. Of particular importance are the available options, and alternatives, for continuous chromatographic separations. Although there are still significant challenges in developing integrated continuous bioprocesses, recent technological advances have provided process developers with a number of attractive options for development of truly continuous bioprocessing operations.

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

    Science.gov (United States)

    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.

  9. 77 FR 74196 - Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication...

    Science.gov (United States)

    2012-12-13

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

  10. Technical suitability mapping of feedstocks for biological hydrogen production

    NARCIS (Netherlands)

    Panagiotopoulos, I.A.; Karaoglanoglou, L.S.; Koullas, D.P.; Bakker, R.R.; Claassen, P.A.M.; Koukios, E.G.

    2015-01-01

    The objective of this work was to map and compare the technical suitability of different raw materials for biological hydrogen production. Our model was based on hydrogen yield potential, sugar mobilization efficiency, fermentability and coproduct yield and value. The suitability of the studied r

  11. MANAGING PRODUCT SAFETY SYSTEM HACCP ON THE EXAMPLE OF BEET-SUGAR PRODUCTION

    Directory of Open Access Journals (Sweden)

    V. A. Golybin

    2015-01-01

    Full Text Available The most effective safety management system of food production in all industrialized countries in the world recognized by the system based on the principles of HACCP. In Russia, the conformity assessment carried out by the HACCP system certification. The essence of the HACCP system is to identify and control the critical points. Critical Control Point – this is the stage of the process, which is subject to control for hazard identification and risk management in order to avoid the production of unsafe products. Implementation of HACCP system allows to tighten and coordinate the quality control system, which will improve the competitiveness of the products produced in the sugar market in Russia and abroad. In the early stages of food production HACCP system to prevent the occurrence of danger. It is based on the preventive approach to ensuring quality and safety in the production process, and can also be used in the development of new products. HACCP system is based on seven main principles to ensure the implementation and management of the system in production. 1. Creation of a working group of the coordinator and the technical secretary and various consultants. 2. Information on materials and products, in this case of sugar beet and sugar. 3. Information about the production. 4. Risk analysis of the available chemical, physical and microbiological factors. To determine the critical control points according to the results obtained for each factor is determined by a special chart the extent of its accounting. The need to consider the potential hazard is determined by the order in which area it has got. 5. The production program of mandatory preliminary activities in the production of sugar. 6. Determination of critical control points. 7. Making worksheets HACCP. It is shown that the use of HACCP in sugar beet production has several advantages.

  12. 9 CFR 103.2 - Disposition of animals administered experimental biological products or live organisms.

    Science.gov (United States)

    2010-01-01

    ... experimental biological products or live organisms. 103.2 Section 103.2 Animals and Animal Products ANIMAL AND... PRODUCTS; ORGANISMS AND VECTORS EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING § 103.2 Disposition of animals administered experimental biological products...

  13. 30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Science.gov (United States)

    2010-07-01

    ... General § 7.10 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as equivalent after determining that they: (1... protection as those MSHA requirements. (b) MSHA will publish its intent to review any non-MSHA product...

  14. 77 FR 58567 - Information Collection Activities: Well Control and Production Safety Training, Submitted for...

    Science.gov (United States)

    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...

  15. Incentives for the Quality and Safety Traceability System of Agricultural Products

    Institute of Scientific and Technical Information of China (English)

    Shizhen; BAI; Meng; LI

    2014-01-01

    The quality and safety traceability system of agricultural products is an important measure to protect the quality and safety of agricultural products. Farmers and food enterprises are main operators of the traceability system. If they are effectively encouraged to practice traceability system,food safety can be guaranteed from the source. This paper studies the incentive problem of agricultural product traceability system from two aspects- vertical contract coordination and government external incentive.

  16. Reinvigorating natural product combinatorial biosynthesis with synthetic biology.

    Science.gov (United States)

    Kim, Eunji; Moore, Bradley S; Yoon, Yeo Joon

    2015-09-01

    Natural products continue to play a pivotal role in drug-discovery efforts and in the understanding if human health. The ability to extend nature's chemistry through combinatorial biosynthesis--altering functional groups, regiochemistry and scaffold backbones through the manipulation of biosynthetic enzymes--offers unique opportunities to create natural product analogs. Incorporating emerging synthetic biology techniques has the potential to further accelerate the refinement of combinatorial biosynthesis as a robust platform for the diversification of natural chemical drug leads. Two decades after the field originated, we discuss the current limitations, the realities and the state of the art of combinatorial biosynthesis, including the engineering of substrate specificity of biosynthetic enzymes and the development of heterologous expression systems for biosynthetic pathways. We also propose a new perspective for the combinatorial biosynthesis of natural products that could reinvigorate drug discovery by using synthetic biology in combination with synthetic chemistry.

  17. PERSPECTIVES FOR DEVELOPMENT OF THE BIOLOGIC PLUM PRODUCTION IN BULGARIA

    Directory of Open Access Journals (Sweden)

    Ivanka Vitanova

    2014-03-01

    Full Text Available The Bulgarian plum cultivars Gabrovska, Nevena, Strinava, Guliaeva and Balvanska slava, breeding in the Plum Experimental Station in the town of Dryanovo and the introduced cultivars Stanley, Chachanska lepotitsa, Opal, Malvazinka, Hramova renkloda, Tuleu timpuriu, Althan’s Gage, Pacific, Mirabell de Nancy, Anna Schpet and Jojo, what are high productive and are tolerant to sharka and other important economic plum diseases are suitable for the biologic plum production. The organic fertilization is a basic element of the technology for the biologic plum production. The fertilization with manure and the green manure with a winter green peas and with a peas-rye mix increased the humus content, influenced positive action on the supplying of the plum plants with the main nutrient macro elements, increased the yield and to be able apply successfully in the plum orchards and at not irrigation conditions.

  18. Study on cooperative development of safety and production in coal mines

    Institute of Scientific and Technical Information of China (English)

    YUAN Qing-he; HOU Yan-hui; HAO Min; YUAN Qing-wen

    2007-01-01

    Based on cooperative theories and analysis of characters of safety and production in coal mines, discussed the relationship and function of cooperative development between safety and production and established a basic cooperative development model.At the same time, a systemic expatiation of the basic principle, the core conception and the contents of the model was given. In the end, the guarantee measures for realization were proposed. The result of the research may have some leading meaning to ensure safety and production in coal enterprises and to achieve synchronous exaltation of production efficiency and the safety degree.

  19. 75 FR 81236 - Consumer Product Safety Act: Notice of Commission Action Lifting Stay of Enforcement of...

    Science.gov (United States)

    2010-12-27

    ... and rugs, and clothing textiles on January 26, 2011. FOR FURTHER INFORMATION CONTACT: Robert ``Jay...).) Dated: December 17, 2010. Todd A. Stevenson, Secretary, Consumer Product Safety Commission. BILLING...

  20. 77 FR 24722 - Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability

    Science.gov (United States)

    2012-04-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Safety of Nanomaterials in... ``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...

  1. Capturing Biological Activity in Natural Product Fragments by Chemical Synthesis.

    Science.gov (United States)

    Crane, Erika A; Gademann, Karl

    2016-03-14

    Natural products have had an immense influence on science and have directly led to the introduction of many drugs. Organic chemistry, and its unique ability to tailor natural products through synthesis, provides an extraordinary approach to unlock the full potential of natural products. In this Review, an approach based on natural product derived fragments is presented that can successfully address some of the current challenges in drug discovery. These fragments often display significantly reduced molecular weights, reduced structural complexity, a reduced number of synthetic steps, while retaining or even improving key biological parameters such as potency or selectivity. Examples from various stages of the drug development process up to the clinic are presented. In addition, this process can be leveraged by recent developments such as genome mining, antibody-drug conjugates, and computational approaches. All these concepts have the potential to identify the next generation of drug candidates inspired by natural products.

  2. Biological effects of electromagnetic fields and recently updated safety guidelines for strong static magnetic fields.

    Science.gov (United States)

    Yamaguchi-Sekino, Sachiko; Sekino, Masaki; Ueno, Shoogo

    2011-01-01

    Humans are exposed daily to artificial and naturally occurring magnetic fields that originate from many different sources. We review recent studies that examine the biological effects of and medical applications involving electromagnetic fields, review the properties of static and pulsed electromagnetic fields that affect biological systems, describe the use of a pulsed electromagnetic field in combination with an anticancer agent as an example of a medical application that incorporates an electromagnetic field, and discuss the recently updated safety guidelines for static electromagnetic fields. The most notable modifications to the 2009 International Commission on Non-Ionizing Radiation Protection guidelines are the increased exposure limits, especially for those who work with or near electromagnetic fields (occupational exposure limits). The recommended increases in exposure were determined using recent scientific evidence obtained from animal and human studies. Several studies since the 1994 publication of the guidelines have examined the effects on humans after exposure to high static electromagnetic fields (up to 9.4 tesla), but additional research is needed to ascertain further the safety of strong electromagnetic fields.

  3. 78 FR 78796 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products...

    Science.gov (United States)

    2013-12-27

    ... Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of... holders of an approved drug or biological product to change the product labeling to reflect certain types... biological product to change the product labeling to reflect certain types of newly acquired information...

  4. [Special considerations for the regulation of biological medicinal products in individualised medicine. More than stratified medicine].

    Science.gov (United States)

    Müller-Berghaus, J; Volkers, P; Scherer, J; Cichutek, K

    2013-11-01

    The term individualised medicine, also called personalised medicine, is commonly used as an equivalent to stratified medicine. However, this is erroneous since quite often it is forgotten that especially biological medicinal products have other aspects of individualization that go beyond mere stratification. The principles of stratified medicine have been applied for biological medicinal products for many years. A historical example is diphtheria antitoxin made from horse serum, while current examples are transfusion of red blood cells and the administration of factor VIII in haemophilia A. The stratifying aspects of these medicinal products are given by the following considerations: diphtheria antitoxin is only administered after a diagnosis of diphtheria and not in other forms of tonsillitis, red blood cells should only be transfused once blood group compatibility as been established and factor VIII replacement is only administered in haemophilia A as opposed to other acquired or hereditary disease of the coagulation system. The peculiarities of biological medicinal products, in particular the inherent variability of the drug, are especially important for autologous cellular medicinal products. In addition to the expected variability of the biological source material there is interindividual variability of patients as cell donors, which make definition of specifications and determination of criteria for pharmaceutical quality and potency tests difficult. Therapy with modified autologous cells, a common and important application of advanced therapy medicinal products, is exemplary for the special considerations that must be made when evaluating pharmaceutical quality, mode of action and toxicological properties of the biological medicine. The clinical investigation of advanced therapy medicinal products with the intent of demonstrating safety and efficacy is particularly challenging because of the complexity of therapy, which often involves invasive interventions

  5. Analysis on Pollution Factors in Asparagus Production and Research on Safety Production Technology

    Institute of Scientific and Technical Information of China (English)

    Liping; MA; Bianqing; HAO; Xiongwu; QIAO

    2013-01-01

    Based on the analysis on the infection degree,infection law and influencing factors of the main diseases on asparagus and the analysis on the pollution factors in asparagus production such as blind pesticide use,atmospheric pollution and acid rain,the pollution of soil and fertilizer,this article proposes asparagus safety production technologies which include the selection of disease-resistant variety and suitable planting field,scientific and reasonable disease control,balanced fertilization,rational irrigation,making a good job of field management, etc.,to reduce pathogenic factors.

  6. Systems biology approaches to understand natural products biosynthesis

    Directory of Open Access Journals (Sweden)

    Cuauhtemoc eLicona-Cassani

    2015-12-01

    Full Text Available Actinomycetes populate soils and aquatic sediments which impose biotic and abiotic challenges for their survival. As a result, actinomycetes metabolism and genomes have evolved to produce an overwhelming diversity of specialized molecules. Polyketides, non-ribosomal peptides, post-translationally modified peptides, lactams and terpenes are well known bioactive natural products with enormous industrial potential. Accessing such biological diversity has proven difficult due to the complex regulation of cellular metabolism in actinomycetes and to the sparse knowledge of their physiology. The past decade, however, has seen the development of omics technologies that have significantly contributed to our better understanding of their biology. Key observations have contributed towards a shift in the exploitation of actinomycetes biology, such as using their full genomic potential, activating entire pathways through key metabolic elicitors and pathway engineering to improve biosynthesis. Here, we review recent efforts devoted to achieving enhanced discovery, activation and manipulation of natural product biosynthetic pathways in model actinomycetes using genome-scale biological datasets.

  7. 21 CFR 600.14 - Reporting of biological product deviations by licensed manufacturers.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Reporting of biological product deviations by... HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS BIOLOGICAL PRODUCTS: GENERAL Establishment Standards § 600.14 Reporting of biological product deviations by licensed manufacturers. (a) Who must report...

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

    Science.gov (United States)

    Lindholm, A

    1988-01-01

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

  9. Chemical safety of cassava products in regions adopting cassava production and processing - experience from Southern Africa

    DEFF Research Database (Denmark)

    Nyirenda, D.B.; Chiwona-Karltun, L.; Chitundu, M.

    2011-01-01

    The cassava belt area in Southern Africa is experiencing an unforeseen surge in cassava production, processing and consumption. Little documentation exists on the effects of this surge on processing procedures, the prevailing levels of cyanogenic glucosides of products consumed and the levels...... of products commercially available on the market. Risk assessments disclose that effects harmful to the developing central nervous system (CNS) may be observed at a lower exposure than previously anticipated. We interviewed farmers in Zambia and Malawi about their cultivars, processing procedures...... and perceptions concerning cassava and chemical food safety. Chips, mixed biscuits and flour, procured from households and markets in three regions of Zambia (Luapula-North, Western and Southern) as well as products from the Northern, Central and Southern regions of Malawi, were analyzed for total cyanogenic...

  10. Reproductive biology traits affecting productivity of sour cherry

    Directory of Open Access Journals (Sweden)

    Milica Fotiric Aksic

    2013-01-01

    Full Text Available The objective of this work was to evaluate variability in reproductive biology traits and the correlation between them in genotypes of 'Oblačinska' sour cherry (Prunus cerasus. High genetic diversity was found in the 41 evaluated genotypes, and significant differences were observed among them for all studied traits: flowering time, pollen germination, number of fruiting branches, production of flower and fruit, number of flowers per bud, fruit set, and limb yield efficiency. The number of fruiting branches significantly influenced the number of flower and fruit, fruit set, and yield efficiency. In addition to number of fruiting branches, yield efficiency was positively correlated with fruit set and production of flower and fruit. Results from principal component analysis suggested a reduction of the reproductive biology factors affecting yield to four main characters: number and structure of fruiting branches, flowering time, and pollen germination. Knowledge of the reproductive biology of the 'Oblačinska' genotypes can be used to select the appropriate ones to be grown or used as parents in breeding programs. In this sense, genotypes II/2, III/9, III/13, and III/14 have very good flower production and satisfactory pollen germination.

  11. Formate Formation and Formate Conversion in Biological Fuels Production

    Directory of Open Access Journals (Sweden)

    Bryan R. Crable

    2011-01-01

    Full Text Available Biomethanation is a mature technology for fuel production. Fourth generation biofuels research will focus on sequestering CO2 and providing carbon-neutral or carbon-negative strategies to cope with dwindling fossil fuel supplies and environmental impact. Formate is an important intermediate in the methanogenic breakdown of complex organic material and serves as an important precursor for biological fuels production in the form of methane, hydrogen, and potentially methanol. Formate is produced by either CoA-dependent cleavage of pyruvate or enzymatic reduction of CO2 in an NADH- or ferredoxin-dependent manner. Formate is consumed through oxidation to CO2 and H2 or can be further reduced via the Wood-Ljungdahl pathway for carbon fixation or industrially for the production of methanol. Here, we review the enzymes involved in the interconversion of formate and discuss potential applications for biofuels production.

  12. The potential of plants as a system for the development and production of human biologics

    Science.gov (United States)

    Chen, Qiang; Davis, Keith R.

    2016-01-01

    The growing promise of plant-made biologics is highlighted by the success story of ZMapp™ as a potentially life-saving drug during the Ebola outbreak of 2014-2016. Current plant expression platforms offer features beyond the traditional advantages of low cost, high scalability, increased safety, and eukaryotic protein modification. Novel transient expression vectors have been developed that allow the production of vaccines and therapeutics at unprecedented speed to control potential pandemics or bioterrorism attacks. Plant-host engineering provides a method for producing proteins with unique and uniform mammalian post-translational modifications, providing opportunities to develop biologics with increased efficacy relative to their mammalian cell-produced counterparts. Recent demonstrations that plant-made proteins can function as biocontrol agents of foodborne pathogens further exemplify the potential utility of plant-based protein production. However, resolving the technical and regulatory challenges of commercial-scale production, garnering acceptance from large pharmaceutical companies, and obtaining U.S. Food and Drug Administration approval for several major classes of biologics are essential steps to fulfilling the untapped potential of this technology. PMID:27274814

  13. The potential of plants as a system for the development and production of human biologics.

    Science.gov (United States)

    Chen, Qiang; Davis, Keith R

    2016-01-01

    The growing promise of plant-made biologics is highlighted by the success story of ZMapp™ as a potentially life-saving drug during the Ebola outbreak of 2014-2016. Current plant expression platforms offer features beyond the traditional advantages of low cost, high scalability, increased safety, and eukaryotic protein modification. Novel transient expression vectors have been developed that allow the production of vaccines and therapeutics at unprecedented speed to control potential pandemics or bioterrorism attacks. Plant-host engineering provides a method for producing proteins with unique and uniform mammalian post-translational modifications, providing opportunities to develop biologics with increased efficacy relative to their mammalian cell-produced counterparts. Recent demonstrations that plant-made proteins can function as biocontrol agents of foodborne pathogens further exemplify the potential utility of plant-based protein production. However, resolving the technical and regulatory challenges of commercial-scale production, garnering acceptance from large pharmaceutical companies, and obtaining U.S. Food and Drug Administration approval for several major classes of biologics are essential steps to fulfilling the untapped potential of this technology.

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

    Science.gov (United States)

    ... Web Content Viewer (JSR 286) Actions ${title} Loading... Frozen, Fully-Cooked Products & Botulism - Food Safety Advisory In ... Clostridium botulinum , were reported in the United States. Frozen, fully-cooked products were suspected of causing these ...

  15. The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals : A simulation study

    NARCIS (Netherlands)

    Vermeer, Niels S.; Ebbers, Hans C.; Straus, Sabine M J M; Leufkens, Hubert G M; Egberts, Toine C G; De Bruin, Marie L.

    2016-01-01

    Background and Objective: The availability of accurate product-specific exposure information is essential in the pharmacovigilance of biologicals, because differences in the safety profile may emerge between products containing the same active substance. In spontaneous adverse drug reaction (ADR) re

  16. The application of transcriptomics in the comparative safety assessment of (GMO-derived) plant products

    NARCIS (Netherlands)

    Kok, E.J.

    2008-01-01

    National and international organizations have discussed current approaches to the safety assessment of complex (plant) food products in general and the safety assessment of GMO-derived food products in particular. One of the recommendations of different expert meetings was that the new analytical te

  17. 75 FR 33312 - Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request...

    Science.gov (United States)

    2010-06-11

    ... HUMAN SERVICES Food and Drug Administration Indexing Structured Product Labeling for Human Prescription... Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are indexing certain... class as a top priority for indexing of product labeling information. FDA is now announcing that...

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

    Science.gov (United States)

    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.

  19. Application of Mixed Group Decision Making to Safety Evaluation of Agricultural Products

    Institute of Scientific and Technical Information of China (English)

    2012-01-01

    In view of the gravity of issues concerning safety of agricultural products and urgency of resolving these issues,after analyzing the problems existing in safety of agricultural products,this article offers a method for evaluating safety of agricultural products on the basis of mixed group decision making.First of all,it introduces the factors influencing safety evaluation of agricultural products;subsequently,given that the judgment matrices offered by the group of experts contain both reciprocal and complementary judgment matrices in the process of jointly participating in evaluation arising from personal preference,it proposes to assemble expert information in order to obtain indicator weight using the OWA operator;finally,the process of evaluating safety of agricultural products is given.

  20. Biological treatment of chicken feather waste for improved biogas production

    Institute of Scientific and Technical Information of China (English)

    Gergely Forgács; Saeid Alinezhad; Amir Mirabdollah; Elisabeth Feuk-Lagerstedt; Ilona Sárvári Horwáth

    2011-01-01

    A two-stage system was developed which combines the biological degradation of keratin-rich waste with the production of biogas.Chicken feather waste was treated biologically with a recombinant Bacillus megaterium strain showing keratinase activity prior to biogas production.Chopped,autoclaved chicken feathers (4%,W/V) were completely degraded,resulting in a yellowish fermentation broth with a level of 0.51 mg/mL soluble proteins after 8 days of cultivation of the recombinant strain.During the subsequent anaerobic batch digestion experiments,methane production of 0.35 Nm3/kg dry feathers (i.e.,0.4 Nm3/kg volatile solids of feathers),corresponding to 80% of the theoretical value on proteins,was achieved from the feather hydrolyzates,independently of the prehydrolysis time period of 1,2 or 8 days.Cultivation with a native keratinase producing strain,Bacillus licheniformis resulted in only 0.25 mg/mL soluble proteins in the feather hydrolyzate,which then was digested achieving a maximum accumulated methane production of 0.31 Nm3/kg dry feathers.Feather hydrolyzates treated with the wild type B.megaterium produced 0.21 Nm3 CH4/kg dry feathers as maximum yield.

  1. 76 FR 66235 - Bar Code Technologies for Drugs and Biological Products; Retrospective Review Under Executive...

    Science.gov (United States)

    2011-10-26

    ... Biological Products; Retrospective Review Under Executive Order 13563; Request for Comments AGENCY: Food and... ] certain human drug products and biological products to have a bar code. Information submitted can help FDA... technologies for the identification, including the unique identification, of drugs and biological products....

  2. 9 CFR 113.29 - Determination of moisture content in desiccated biological products.

    Science.gov (United States)

    2010-01-01

    ... desiccated biological products. 113.29 Section 113.29 Animals and Animal Products ANIMAL AND PLANT HEALTH... biological products. Methods provided in this section must be used when a determination of moisture content in desiccated biological products is prescribed in an applicable Standard Requirement or in the...

  3. 9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.

    Science.gov (United States)

    2010-01-01

    ..., dangerous, or harmful biological products. 105.3 Section 105.3 Animals and Animal Products ANIMAL AND PLANT... Notices re: worthless, contaminated, dangerous, or harmful biological products. (a) If at any time it...-Serum-Toxin Act, of any biological product by any person holding a license or permit may be dangerous...

  4. SAFETY

    CERN Multimedia

    Niels Dupont

    2013-01-01

    CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

  5. Assessing quality and safety of food and beverage products in Albanian processing enterprises

    OpenAIRE

    Kapaj, Ilir

    2012-01-01

    It is apparent that the consumers, for many reasons, do not have the ability to control directly the product they are purchasing. It is the FBE who have the ability to control and manage the quality and the safety of the products keeping in mind the customers? expectations of a product in terms of quality and safety. The mechanism that realizes this demand today is certification, a process that every product and system of quality and safety management in an enterprise should undergo. The mana...

  6. Safety of biological therapies for psoriasis: effects on reproductive potential and outcomes in male and female patients.

    Science.gov (United States)

    Yiu, Z Z N; Griffiths, C E M; Warren, R B

    2014-09-01

    The effects of biological therapies for psoriasis on pregnancy outcomes and lactation, and male fertility and mutagenicity are common concerns in the clinical setting. There is relatively little evidence to guide the clinician and patient. Here, we review the safety profile of the commonly used biological therapies for psoriasis in individuals of reproductive potential. Safety data were derived from large-scale registries, adverse event reporting databases, clinical trials and case reports. We assessed the effect of each therapy on adverse pregnancy outcomes including congenital malformations, and lactation with maternal administration, and male fertility and potential mutagenicity with paternal administration. We provide applicable guidance to inform clinician and patient before and after conception.

  7. 16 CFR 1115.5 - Reporting of failures to comply with a voluntary consumer product safety standard relied upon by...

    Science.gov (United States)

    2010-01-01

    ... voluntary consumer product safety standard relied upon by the Commission under section 9 of the CPSA. 1115.5 Section 1115.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SUBSTANTIAL PRODUCT HAZARD REPORTS General Interpretation § 1115.5 Reporting of failures to...

  8. Assessment of nitrogen and sulphur cycle bacteria and shrimp production in ponds treated with biological products

    Institute of Scientific and Technical Information of China (English)

    Thangapalam Jawahar Abraham; Shubhadeep Ghosh; Debasis Sasmal

    2015-01-01

    Objective:To study the influence of biological products on the levels of nitrogen and sulphur cycle bacteria in shrimp culture systems of West Bengal, India. Methods: The pond water and sediment samples were analyzed for physico-chemical parameters as per standard methods. The bacteria involved in ammonification, nitrification, denitrification, sulphate reduction and sulphur oxidation were enumerated by most probable number technique. Results:The semi-intensive and modified extensive shrimp farms used a variety of biological products during various stages of production. No biological products were used in traditional farms. The water and sediment samples of modified extensive system recorded significantly higher mean heterotrophic bacterial counts. The counts of ammonia, nitrite and sulphur oxidizers, and nitrate and sulphate reducers varied among the systems. The cycling of nitrogen and sulphur appeared to be affected with the intensification of culture practices. Conclusions:The application of biological products in certain systems helped to maintain the bacteria involved in nitrogen and sulphur cycles and safe levels of ammonia, nitrite and nitrate. An assessment of these metabolically active bacteria in shrimp culture ponds and the application of right kind microbial products would help ameliorate the organic pollution in shrimp aquaculture.

  9. 78 FR 59632 - Oil and Gas and Sulphur Operations on the Outer Continental Shelf-Oil and Gas Production Safety...

    Science.gov (United States)

    2013-09-27

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

  10. 77 FR 10358 - Acceptance of ASTM F963-11 as a Mandatory Consumer Product Safety Standard

    Science.gov (United States)

    2012-02-22

    ... COMMISSION 16 CFR Chapter II Acceptance of ASTM F963-11 as a Mandatory Consumer Product Safety Standard... ASTM F963-11 standard titled, Standard Consumer Safety Specifications for Toy Safety. Pursuant to section 106 of the Consumer Product Safety Improvement Act of 2008, ASTM F963-11 will become a...

  11. Safety

    CERN Multimedia

    2003-01-01

    Please note that the safety codes A9, A10 AND A11 (ex annexes of SAPOCO/42) entitled respectively "Safety responsibilities in the divisions" "The safety policy committee (SAPOCO) and safety officers' committees" and "Administrative procedure following a serious accident or incident" are available on the web at the following URLs: Code A9: http://edms.cern.ch/document/337016/LAST_RELEASED Code A10: http://edms.cern.ch/document/337019/LAST_RELEASED Code A11: http://edms.cern.ch/document/337026/LAST_RELEASED Paper copies can also be obtained from the TIS divisional secretariat, e-mail: tis.secretariat@cern.ch. TIS Secretariat

  12. Biological risks associated with consumption of reptile products

    DEFF Research Database (Denmark)

    Magnino, S.; Colin, P.; Dei-Cas, E.

    2009-01-01

    recently increased in some areas of the world. Biological risks associated with the consumption of products from both farmed and wild reptile meat and eggs include infections caused by bacteria (Salmonella spp., Vibrio spp.). parasites (Spirometra, Trichinella, Gnathostoma, pentastomids), as well...... as intoxications by biotoxins. For crocodiles, Salmonella spp. constitute a significant public health risk due to the high intestinal carrier rate which is reflected in an equally high contamination rate in their fresh and frozen meat. There is a lack of information about the presence of Salmonella spp. in meat...

  13. Current studies on physiological functions and biological production of lactosucrose.

    Science.gov (United States)

    Mu, Wanmeng; Chen, Qiuming; Wang, Xiao; Zhang, Tao; Jiang, Bo

    2013-08-01

    Lactosucrose (O-β-D-galactopyranosyl-(1,4)-O-α-D-glucopyranosyl-(1,2)-β-D-fructofuranoside) is a trisaccharide formed from lactose and sucrose by enzymatic transglycosylation. This rare trisaccharide is a kind of indigestible carbohydrate, has good prebiotic effect, and promotes intestinal mineral absorption. It has been used as a functional ingredient in a range of food products which are approved as foods for specified health uses in Japan. Using lactose and sucrose as substrates, lactosucrose can be produced through transfructosylation by β-fructofuranosidase from Arthrobacter sp. K-1 or a range of levansucrases, or through transgalactosylation by β-galactosidase from Bacillus circulans. This article presented a review of recent studies on the physiological functions of lactosucrose and the biological production from lactose and sucrose by different enzymes.

  14. Concepts for Safety Stock Determination under Stochastic Demand and Different Types of Random Production Yield

    OpenAIRE

    Karl Inderfurth; Stephanie Vogelgesang

    2011-01-01

    We consider a manufacturer's stochastic production/inventory problem under periodic review and present concepts for safety stock determination to cope with uncertainties that are caused by stochastic demand and different types of yield randomness. Order releases follow a linear control rule. Taking manufacturing lead times into account it turns out that safety stocks have to be considered that vary from period to period. We present an approach for calculating these dynamic safety stocks. Addi...

  15. Study on the Problems and Countermeasure in the Animal Products Quality and Safety

    Institute of Scientific and Technical Information of China (English)

    Shishan; WANG

    2013-01-01

    As the supply chain of animal products is long,there are many factors which would influence the quality safety of animal production.Therefore,by focusing on the present and having a vision for future,Jiaozuo government promulgated Ten Polices on the Food Safety in Jiaozuo City,which pushed forward the technological development,intensified measures to monitor the quality of animal products,set up a series of mechanism,and provided reference for the food quality and safety monitoring.

  16. 21 CFR 601.26 - Reclassification procedures to determine that licensed biological products are safe, effective...

    Science.gov (United States)

    2010-04-01

    ... licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or... Reclassification procedures to determine that licensed biological products are safe, effective, and not misbranded... for the reclassification of all biological products that have been classified into Category IIIA....

  17. 78 FR 12760 - Guidance for Industry on Labeling for Human Prescription Drug and Biological Products...

    Science.gov (United States)

    2013-02-25

    ... Drug and Biological Products--Implementing the Physician Labeling Rule Content and Format Requirements... Prescription Drug and Biological Products--Implementing the PLR Content and Format Requirements.'' This... for human prescription drug and biological products. The recommendations in this guidance will...

  18. 37 CFR 1.779 - Calculation of patent term extension for a veterinary biological product.

    Science.gov (United States)

    2010-07-01

    ... extension for a veterinary biological product. 1.779 Section 1.779 Patents, Trademarks, and Copyrights... Calculation of patent term extension for a veterinary biological product. (a) If a determination is made pursuant to § 1.750 that a patent for a veterinary biological product is eligible for extension, the...

  19. IT safety in production data networks (PDN). Tracking, evaluation and elimination of safety threats; IT-Sicherheit in Produktionsnetzen (PDN). Aufspueren, einschaetzen und beseitigen von Sicherheitsbedrohungen

    Energy Technology Data Exchange (ETDEWEB)

    Neider, Ulrich [DETACK GmbH, Ludwigsburg (Germany)

    2013-03-01

    This contribution reports on the threats of production data networks. Within the context of the IT security, the risks of production data networks are not only based on a possible contamination by computer viruses. The author of this contribution increases awareness of dangers to whose production systems are faced. The author also presents a phase model from his own consulting practice in order to increase the safety of production data systems by implementation of a safety control. This phase model consists of the six following steps: (a) Stock taking of the state of the art; (b) Determination of the target (development of a safety concept); (c) Creation of an IT safety policy; (d) Application of IT safety policy; (e) Audit of the results (IT safety audit); (f) Regular safety tests.

  20. A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs).

    Science.gov (United States)

    Jones, David R; McBlane, James W; McNaughton, Graham; Rajakumaraswamy, Nishanthan; Wydenbach, Kirsty

    2013-08-01

    The safety of trial subjects is the tenet that guides the regulatory assessment of a Clinical Trial Authorization application and applies equally to trials involving small molecules and those with biological/biotechnological products, including Advanced Therapy Medicinal Products. The objective of a regulator is to ensure that the potential risk faced by a trial subject is outweighed by the potential benefit to them from taking part in the trial. The focus of the application review is to assess whether risks have been identified and appropriate steps taken to alleviate these as much as possible. Other factors are also taken into account during a review, such as regulatory requirements, and emerging non-clinical and clinical data from other trials on the same or similar products. This paper examines the regulatory review process of a Clinical Trial Authorization application from the perspectives of Quality, Non-Clinical and Clinical Regulatory Assessors at the Medicines and Healthcare products Regulatory Agency. It should be noted that each perspective has highlighted specific issues from their individual competence and that these can be different between the disciplines.

  1. Biological evaluation of nanosilver incorporated cellulose pulp for hygiene products.

    Science.gov (United States)

    Kavitha Sankar, P C; Ramakrishnan, Reshmi; Rosemary, M J

    2016-04-01

    Cellulose pulp has a visible market share in personal hygiene products such as sanitary napkins and baby diapers. However it offers good surface for growth of microorganisms. Huge amount of research is going on in developing hygiene products that do not initiate microbial growth. The objective of the present work is to produce antibacterial cellulose pulp by depositing silver nanopowder on the cellulose fiber. The silver nanoparticles used were of less than 100 nm in size and were characterised using transmission electron microscopy and X-ray powder diffraction studies. Antibacterial activity of the functionalized cellulose pulp was proved by JIS L 1902 method. The in-vitro cytotoxicity, in-vivo vaginal irritation and intracutaneous reactivity studies were done with silver nanopowder incorporated cellulose pulp for introducing a new value added product to the market. Cytotoxicity evaluation suggested that the silver nanoparticle incorporated cellulose pulp is non-cytotoxic. No irritation and skin sensitization were identified in animals tested with specific extracts prepared from the test material in the in-vivo experiments. The results indicated that the silver nanopowder incorporated cellulose pulp meets the requirements of the standard practices recommended for evaluating the biological reactivity and has good biocompatibility, hence can be classified as a safe hygiene product.

  2. 77 FR 51912 - Safety Zone; Tom Lyons Productions Fireworks, Long Island Sound, Sands Point, NY

    Science.gov (United States)

    2012-08-28

    ... SECURITY Coast Guard 33 CFR Part 165 RIN 1625-AA00 Safety Zone; Tom Lyons Productions Fireworks, Long Island Sound, Sands Point, NY AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast... vicinity of Sands Point, NY. This temporary safety zone is necessary to protect spectators and vessels...

  3. 30 CFR 250.802 - Design, installation, and operation of surface production-safety systems.

    Science.gov (United States)

    2010-07-01

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

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

    Science.gov (United States)

    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…

  5. Towards a decision support system for control of multiple food safety hazards in raw milk production

    NARCIS (Netherlands)

    Spiegel, van der M.; Sterrenburg, P.; Haasnoot, W.; Fels-Klerx, van der H.J.

    2013-01-01

    Decision support systems (DSS) for controlling multiple food safety hazards in raw milk production have not yet been developed, but the underlying components are fragmentarily available. This article presents the state-of-the-art of essential DSS elements for judging food safety compliance of raw mi

  6. Food safety management systems performance in the lamb production chain

    NARCIS (Netherlands)

    Oses, S.M.; Luning, P.A.; Jacxsens, L.; Jaime, I.; Rovira, J.

    2012-01-01

    This study describes a performance measurement of implemented food safety management system (FSMS) along the lamb chain using an FSMS-diagnostic instrument (FSMS-DI) and a Microbiological Assessment Scheme (MAS). Three slaughterhouses, 1 processing plant and 5 butcher shops were evaluated. All the a

  7. Biological productivity and carbon cycling in the Arctic Ocean

    Institute of Scientific and Technical Information of China (English)

    2002-01-01

    Primary production, bacterial production, particulate organic carbon fluxes and organic carbon burial rates were quantified during the summer period of 1999 in the Arctic Ocean via 14C uptake, 3H uptake, 234Th/238U disequilibrium and 210Pbex dating, respectively. The integrated primary production in the water column was as high as 197 mmolC/(m2@d) in the Chukchi shelf and was 3.8 mmolC/(m2@d) in the Canada Basin. These rates are higher than those reported previously. The ratios of bacterial production to primary production in the study region were higher than 0.5, indicating that microbial activity is not depressed but important in cold Arctic waters. 234Th/238U disequilibria were evident at the station in the Canada Basin. The presence of significant 234Th deficiency suggested that scavenging and removal processes are also important to biogeochemical cycles of trace elements in the Arctic Ocean. Particulate organic carbon export flux was estimated to be 1.0 mmolC/(m2@d). Measurements of sediment excess 210Pb profile in the Chukchi shelf allowed us to estimate the amount of organic carbon buried in the bottom sediment, which ranged from 25 to 35 mmolC/(m2@d) and represented about 59%-82% of the mean primary production in the euphotic zone. Overall, our results indicated that the Arctic Ocean has active carbon cycling and is not a biological desert as previously believed. Therefore, the Arctic Ocean may play an important role in the global carbon cycle and climate change.

  8. Moderating effect of perceived risk on the relationship between product safety and intention

    Directory of Open Access Journals (Sweden)

    Sarina Ismail

    2015-02-01

    Full Text Available Herbal Products industry has experienced significant growth in product demand. Therefore, this study aims to identify the factors effecting the actual buying of Herbal Product. This study also examines the moderation effect of perceived risk on the relationship between product safety and intention. Mall intercept survey was used to collect data from six various states in Malaysia. The data is analyzed using Partial Least Squares (PLS path modeling. The path coefficient results supported the direct influence of intention on actual buying. Similarly, the findings reveal that perceived risk moderate the relationship between product safety and buying intention.

  9. Improving food safety in the supply chain: Integrating traceability in production and distribution planning

    DEFF Research Database (Denmark)

    Grunow, Martin; Rong, Aiying; Akkerman, Renzo

    2008-01-01

    After a number of food safety crises, the design and implementation of traceability systems became an important focus of the food industry. As a result, food product traceability ranks high on senior management agendas for supply chain activities. In the literature, numerous studies deal...... on production and distribution planning. Here, we develop a methodology for production and distribution planning in food supply chains which minimizes production and logistics costs and at the same time reduces food safety concerns, limits the size of potential recalls, and satisfies product quality...... requirements throughout the supply chain. We also demonstrate the effectiveness of the methodology using a small case study....

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

    Science.gov (United States)

    2010-01-01

    ... 101 of the Consumer Product Safety Improvement Act for certain electronic devices. 1500.88 Section 1500.88 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

  11. Construction of the All-region Linkage System for Emergency Management of Agricultural Product Quality and Safety in West China

    Institute of Scientific and Technical Information of China (English)

    Hua; YU; Yanbin; QI; Yubao; YAN

    2013-01-01

    Quality and safety of agricultural products are significant for national socioeconomic development,sustainable development,and vital interests of people.To safeguard quality and safety of agricultural products in west China is to safeguard economic safety and ecological safety of the country,public health and social stability,of which an important task is to properly handle emergencies concerning quality and safety of agricultural products.Considering actual conditions of west China,suggestions are given to construct the all-region linkage system for emergency management of agricultural product quality and safety in the local area,enhance the all-region linkage,and improve the linkage efficiency.

  12. Suitability of Gray Water for Hydroponic Crop Production Following Biological and Physical Chemical and Biological Subsystems

    Science.gov (United States)

    Bubenheim, David L.; Harper, Lynn D.; Wignarajah, Kanapathipillai; Greene, Catherine

    1994-01-01

    The water present in waste streams from a human habitat must be recycled in Controlled Ecological Life Support Systems (CELSS) to limit resupply needs and attain self-sufficiency. Plants play an important role in providing food, regenerating air, and producing purified water via transpiration. However, we have shown that the surfactants present in hygiene waste water have acute toxic effects on plant growth (Bubenheim et al. 1994; Greene et al., 1994). These phytotoxic affects can be mitigated by allowing the microbial population on the root surface to degrade the surfactant, however, a significant suppression (several days) in crop performance is experienced prior to reaching sub-toxic surfactant levels and plant recovery. An effective alternative is to stabilize the microbial population responsible for degradation of the surfactant on an aerobic bioreactor and process the waste water prior to utilization in the hydroponic solution (Wisniewski and Bubenheim, 1993). A sensitive bioassay indicates that the surfactant phytotoxicity is suppressed by more than 90% within 5 hours of introduction of the gray water to the bioreactor; processing for more than 12 hours degrades more than 99% of the phytotoxin. Vapor Compression Distillation (VCD) is a physical / chemical method for water purification which employees sequential distillation steps to separate water from solids and to volatilize contaminants. The solids from the waste water are concentrated in a brine and the pure product water (70 - 90% of the total waste water volume depending on operating conditions) retains non of the phytotoxic effects. Results of the bioassay were used to guide evaluations of the suitability of recovered gray water following biological and VCD processing for hydroponic lettuce production in controlled environments. Lettuce crops were grown for 28 days with 100% of the input water supplied with recovered water from the biological processor or VCD. When compared with the growth of plants

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

    Science.gov (United States)

    2012-05-31

    ... possess and use source material for a fluorine extraction and depleted uranium deconversion facility. The... COMMISSION Safety Evaluation Report, International Isotopes Fluorine Products, Inc., Fluorine Extraction Process and Depleted Uranium Deconversion Plan, Lea County, NM AGENCY: Nuclear Regulatory...

  14. Flow and performance of an air-curtain biological safety cabinet.

    Science.gov (United States)

    Huang, Rong Fung; Chou, Chun I

    2009-06-01

    Using laser-assisted smoke flow visualization and tracer gas concentration detection techniques, this study examines aerodynamic flow properties and the characteristics of escape from containment, inward dispersion, and cross-cabinet contamination of a biological safety cabinet installed with an air curtain across the front aperture. The experimental method partially simulates the NSF/ANSI 49 standards with the difference that the biological tracer recommended by these standards is replaced by a mixture of 10% SF(6) in N(2). The air curtain is set up across the cabinet aperture plane by means of a narrow planar jet issued from the lower edge of the sash and a suction flow going through a suction slot installed at the front edge of the work surface. Varying the combination of jet velocity, suction flow velocity, and descending flow velocity reveals three types of characteristic flow modes: 'straight curtain', 'slightly concave curtain', and 'severely concave curtain'. Operating the cabinet in the straight curtain mode causes the air curtain to impinge on the doorsill and therefore induces serious escape from containment. In the severely concave curtain mode, drastically large inward dispersion and cross-cabinet contamination were observed because environmental air entered into the cabinet and a three-dimensional vortical flow structure formed in the cabinet. The slightly concave curtain mode presents a smooth and two-dimensional flow pattern with an air curtain separating the outside atmosphere from the inside space of the cabinet, and therefore exhibited negligibly small escape from containment, inward dispersion, and cross-cabinet contamination.

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

    Science.gov (United States)

    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.

  16. The application of transcriptomics in the comparative safety assessment of (GMO-derived) plant products

    OpenAIRE

    Kok, E.J.

    2008-01-01

    National and international organizations have discussed current approaches to the safety assessment of complex (plant) food products in general and the safety assessment of GMO-derived food products in particular. One of the recommendations of different expert meetings was that the new analytical techniques, in particular the ‘omics’ approaches, need to be explored for their potential to improve the analysis and thereby the toxicological and nutritional assessment of complex (GMO-derived) pla...

  17. Biological production of ethanol from coal. Final report

    Energy Technology Data Exchange (ETDEWEB)

    1992-12-01

    Due to the abundant supply of coal in the United States, significant research efforts have occurred over the past 15 years concerning the conversion of coal to liquid fuels. Researchers at the University of Arkansas have concentrated on a biological approach to coal liquefaction, starting with coal-derived synthesis gas as the raw material. Synthesis gas, a mixture of CO, H{sub 2}, CO{sub 2}, CH{sub 4} and sulfur gases, is first produced using traditional gasification techniques. The CO, CO{sub 2} and H{sub 2} are then converted to ethanol using a bacterial culture of Clostridium 1jungdahlii. Ethanol is the desired product if the resultant product stream is to be used as a liquid fuel. However, under normal operating conditions, the ``wild strain`` produces acetate in favor of ethanol in conjunction with growth in a 20:1 molar ratio. Research was performed to determine the conditions necessary to maximize not only the ratio of ethanol to acetate, but also to maximize the concentration of ethanol resulting in the product stream.

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

    Science.gov (United States)

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

    2014-05-07

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

  19. 21 CFR 601.25 - Review procedures to determine that licensed biological products are safe, effective, and not...

    Science.gov (United States)

    2010-04-01

    ... biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested... determine that licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use. For purposes of reviewing biological products that have...

  20. A Disadvantageous Dichotomy in Product Safety Law – Some Reflections on Sense and Nonsense of the Distinction Food–Nonfood in European Product Safety Law

    NARCIS (Netherlands)

    Brack, Antoni

    2009-01-01

    This paper researches a number of similarities and differences between European legal regimens with regard to food and non–food product safety, based on the assumption that these regimens may have overly diverged. A tentative conclusion is that there are enough similarities to justify an effort to r

  1. Chemical compositional, biological, and safety studies of a novel maple syrup derived extract for nutraceutical applications.

    Science.gov (United States)

    Zhang, Yan; Yuan, Tao; Li, Liya; Nahar, Pragati; Slitt, Angela; Seeram, Navindra P

    2014-07-16

    Maple syrup has nutraceutical potential given the macronutrients (carbohydrates, primarily sucrose), micronutrients (minerals and vitamins), and phytochemicals (primarily phenolics) found in this natural sweetener. We conducted compositional (ash, fiber, carbohydrates, minerals, amino acids, organic acids, vitamins, phytochemicals), in vitro biological, and in vivo safety (animal toxicity) studies on maple syrup extracts (MSX-1 and MSX-2) derived from two declassified maple syrup samples. Along with macronutrient and micronutrient quantification, thirty-three phytochemicals were identified (by HPLC-DAD), and nine phytochemicals, including two new compounds, were isolated and identified (by NMR) from MSX. At doses of up to 1000 mg/kg/day, MSX was well tolerated with no signs of overt toxicity in rats. MSX showed antioxidant (2,2-diphenyl-1-picrylhydrazyl (DPPH) assay) and anti-inflammatory (in RAW 264.7 macrophages) effects and inhibited glucose consumption (by HepG2 cells) in vitro. Thus, MSX should be further investigated for potential nutraceutical applications given its similarity in chemical composition to pure maple syrup.

  2. Ontology-supported research on vaccine efficacy, safety and integrative biological networks.

    Science.gov (United States)

    He, Yongqun

    2014-07-01

    While vaccine efficacy and safety research has dramatically progressed with the methods of in silico prediction and data mining, many challenges still exist. A formal ontology is a human- and computer-interpretable set of terms and relations that represent entities in a specific domain and how these terms relate to each other. Several community-based ontologies (including Vaccine Ontology, Ontology of Adverse Events and Ontology of Vaccine Adverse Events) have been developed to support vaccine and adverse event representation, classification, data integration, literature mining of host-vaccine interaction networks, and analysis of vaccine adverse events. The author further proposes minimal vaccine information standards and their ontology representations, ontology-based linked open vaccine data and meta-analysis, an integrative One Network ('OneNet') Theory of Life, and ontology-based approaches to study and apply the OneNet theory. In the Big Data era, these proposed strategies provide a novel framework for advanced data integration and analysis of fundamental biological networks including vaccine immune mechanisms.

  3. Production and biological activities of yellow pigments from Monascus fungi.

    Science.gov (United States)

    Chen, Gong; Wu, Zhenqiang

    2016-08-01

    Monascus yellow pigments (MYPs), are azaphilone compounds and one of the three main components of total Monascus pigments (MPs). Thirty-five hydrophilic or hydrophobic MYPs have been identified, with the majority being hydrophobic. Apart from screening special Monascus strains, some advanced approaches, such as extractive and high-cell-density fermentations, have been applied for developing or producing new MYPs, especially extracellular hydrophilic MYPs. The outstanding performance of MYPs in terms of resistance to photodegradation, as well as tolerance for temperature and pH, give natural MYPs reasonable prospects, compared with the orange and red MPs, for practical use in the present and future. Meanwhile, MYPs have shown promising potential for applications in the food and pharmaceutical industries based on their described bioactivities. This review briefly summarizes the reports to date on chemical structures, biological activities, biosynthetic pathways, production technologies, and physicochemical performances of MYPs. The existing problems for MYPs are discussed and research prospects proposed.

  4. Management of Rheumatoid Arthritis Patients with Interstitial Lung Disease: Safety of Biological Antirheumatic Drugs and Assessment of Pulmonary Fibrosis.

    Science.gov (United States)

    Mori, Shunsuke

    2015-01-01

    Interstitial lung disease (ILD) is one of the major causes of morbidity and mortality of patients with rheumatoid arthritis (RA). Accompanying the increased number of reports on the development or exacerbation of ILD in RA patients following therapy with biological disease-modifying antirheumatic drugs (DMARDs), RA-associated ILD (RA-ILD) has aroused renewed interest. Although such cases have been reported mainly in association with the use of tumor necrosis factor inhibitors, the use of other biological DMARDs has also become a matter of concern. Nevertheless, it is difficult to establish a causative relationship between the use of biological DMARDs and either the development or exacerbation of ILD. Such pulmonary complications may occur in the natural course of RA regardless of the use of biological DMARDs. Since rheumatologists currently aim to achieve remission in RA patients, the administration of biological DMARDs is increasing, even for those with RA-ILD. However, there are no reliable, evidence-based guidelines for deciding whether biological DMARDs can be safely introduced and continued in RA-ILD patients. A standardized staging system for pulmonary conditions of RA-ILD patients is needed when making therapeutic decisions at baseline and monitoring during biological DMARD therapy. Based on the available information regarding the safety of biological DMARDs and the predictive factors for a worse prognosis, this review discusses candidate parameters for risk evaluation of ILD in RA patients who are scheduled to receive biological antirheumatic therapy.

  5. 9 CFR 112.9 - Biological products imported for research and evaluation.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Biological products imported for research and evaluation. 112.9 Section 112.9 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... PACKAGING AND LABELING § 112.9 Biological products imported for research and evaluation. A...

  6. 77 FR 47397 - Request for Nominations of Specific Drug/Biologic Product(s) That Could Be Brought Before the...

    Science.gov (United States)

    2012-08-08

    ... HUMAN SERVICES Food and Drug Administration Request for Nominations of Specific Drug/Biologic Product(s... invites the public to suggest one or more specific drug or biologic products that could be brought before... Drugs Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for...

  7. Safety Aspects of Local Tropical Food Production: Essential Oil Incorporation as a Safe Approach

    Directory of Open Access Journals (Sweden)

    Viroj Wiwanitkit

    2015-03-01

    Full Text Available The local food production can be seen worldwide and there are several local wisdoms on food production. The problem on the local food production can be seen and the problem of microbiological contamination is the great concern. The safety consideration is required. In the tropical world, the problem of local tropical food production should be specially discussed. There are many cases of problematic microbiological contamination and the quality management is still the issue for further development.A safe and acceptable approach to increase safety and shelf life of the tropical foods is application of essential oil.

  8. 9 CFR 118.3 - Movement of detained biological products; Termination of detention.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Movement of detained biological... VECTORS DETENTION; SEIZURE AND CONDEMNATION § 118.3 Movement of detained biological products; Termination of detention. Except as provided in paragraphs (a) and (b) of this section, no biological...

  9. 76 FR 52668 - Vaccines and Related Biological Products Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2011-08-23

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... Administration (FDA) is announcing an amendment to the notice of meeting of the Vaccines and Related Biological... announced that a meeting of the Vaccines and Related Biological Products Advisory Committee would be held...

  10. 76 FR 13646 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-03-14

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological... Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. In...

  11. 77 FR 3780 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-01-25

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological..., Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics...

  12. 75 FR 29155 - Publicly Available Consumer Product Safety Information Database

    Science.gov (United States)

    2010-05-24

    ... information, such as where the product was purchased, price paid, model, serial number, date of manufacture... considered as verification including sales, promotion, marketing or warranty activities or...

  13. Competency development in antibody production in cancer cell biology

    Energy Technology Data Exchange (ETDEWEB)

    Park, M.S.

    1998-12-01

    This is the final report of a three-year, Laboratory Directed Research and Development (LDRD) project at Los Alamos National Laboratory (LANL). The main objective of this project was to develop a rapid recombinant antibody production technology. To achieve the objective, the authors employed (1) production of recombinant antigens that are important for cell cycle regulation and DNA repair, (2) immunization and specific selection of antibody-producing lymphocytes using the flow cytometry and magnetic bead capturing procedure, (3) construction of single chain antibody library, (4) development of recombinant vectors that target, express, and regulate the expression of intracellular antibodies, and (5) specific inhibition of tumor cell growth in tissue culture. The authors have accomplished (1) optimization of a selection procedure to isolate antigen-specific lymphocytes, (2) optimization of the construction of a single-chain antibody library, and (3) development of a new antibody expression vector for intracellular immunization. The future direction of this research is to continue to test the potential use of the intracellular immunization procedure as a tool to study functions of biological molecules and as an immuno-cancer therapy procedure to inhibit the growth of cancer cells.

  14. Biological hydrogen production measured in batch anaerobic respirometers.

    Science.gov (United States)

    Logan, Bruce E; Oh, Sang-Eun; Kim, In S; Van Ginkel, Steven

    2002-06-01

    The biological production of hydrogen from the fermentation of different substrates was examined in batch tests using heat-shocked mixed cultures with two techniques: an intermittent pressure release method (Owen method) and a continuous gas release method using a bubble measurement device (respirometric method). Under otherwise identical conditions, the respirometric method resulted in the production of 43% more hydrogen gas from glucose than the Owen method. The lower conversion of glucose to hydrogen using the Owen protocol may have been produced by repression of hydrogenase activity from high partial pressures in the gastight bottles, but this could not be proven using a thermodynamic/rate inhibition analysis. In the respirometric method, total pressure in the headspace never exceeded ambient pressure, and hydrogen typically composed as much as 62% of the headspace gas. High conversion efficiencies were consistently obtained with heat-shocked soils taken at different times and those stored for up to a month. Hydrogen gas composition was consistently in the range of 60-64% for glucose-grown cultures during logarithmic growth but declined in stationary cultures. Overall, hydrogen conversion efficiencies for glucose cultures were 23% based on the assumption of a maximum of 4 mol of hydrogen/ mol of glucose. Hydrogen conversion efficiencies were similar for sucrose (23%) and somewhat lower for molasses (15%) but were much lower for lactate (0.50%) and cellulose (0.075%).

  15. Biological removal of cationic fission products from nuclear wastewater.

    Science.gov (United States)

    Ngwenya, N; Chirwa, E M N

    2011-01-01

    Nuclear energy is becoming a preferred energy source amidst rising concerns over the impacts of fossil fuel based energy on global warming and climate change. However, the radioactive waste generated during nuclear power generation contains harmful long-lived fission products such as strontium (Sr). In this study, cationic strontium uptake from solution by microbial cultures obtained from mine wastewater is evaluated. A high strontium removal capacity (q(max)) with maximum loading of 444 mg/g biomass was achieved by a mixed sulphate reducing bacteria (SRB) culture. Sr removal in SRB was facilitated by cell surface based electrostatic interactions with the formation of weak ionic bonds, as 68% of the adsorbed Sr(2+) was easily desorbed from the biomass in an ion exchange reaction with MgCl₂. To a lesser extent, precipitation reactions were also found to account for the removal of Sr from aqueous solution as about 3% of the sorbed Sr was precipitated due to the presence of chemical ligands while the remainder occurred as an immobile fraction. Further analysis of the Sr-loaded SRB biomass by scanning electron microscopy (SEM) coupled to energy dispersive X-ray (EDX) confirmed extracellular Sr(2+) precipitation as a result of chemical interaction. In summary, the obtained results demonstrate the prospects of using biological technologies for the remediation of industrial wastewaters contaminated by fission products.

  16. Diffuse large B-cell lymphoma associated with the use of biologic and other investigational agents: the importance of long-term post-marketing safety surveillance.

    Science.gov (United States)

    Goddard, Allison; Borovicka, Judy H; West, Dennis P; Evens, Andrew M; Laumann, Anne

    2011-01-01

    This case report describes a patient who developed diffuse large B-cell lymphoma (DLBCL) after receiving courses of two investigational biologic agents and cyclosporine followed by more than four years of subcutaneous efalizumab for the treatment of extensive chronic plaque psoriasis. Three years later, the patient remains free of lymphoma and his psoriasis is well controlled with thrice-weekly narrow-band ultraviolet phototherapy. This case emphasizes the importance of continued long-term post-marketing safety surveillance and the early reporting of all possible serious side effects, including cancers, related to the use of any newly available product. In particular, surveillance should focus on the immunomodulating biologic agents in order to identify possible dangerous sequelae.

  17. Space Biology and Medicine. Volume 4; Health, Performance, and Safety of Space Crews

    Science.gov (United States)

    Dietlein, Lawrence F. (Editor); Pestov, Igor D. (Editor)

    2004-01-01

    Volume IV is devoted to examining the medical and associated organizational measures used to maintain the health of space crews and to support their performance before, during, and after space flight. These measures, collectively known as the medical flight support system, are important contributors to the safety and success of space flight. The contributions of space hardware and the spacecraft environment to flight safety and mission success are covered in previous volumes of the Space Biology and Medicine series. In Volume IV, we address means of improving the reliability of people who are required to function in the unfamiliar environment of space flight as well as the importance of those who support the crew. Please note that the extensive collaboration between Russian and American teams for this volume of work resulted in a timeframe of publication longer than originally anticipated. Therefore, new research or insights may have emerged since the authors composed their chapters and references. This volume includes a list of authors' names and addresses should readers seek specifics on new information. At least three groups of factors act to perturb human physiological homeostasis during space flight. All have significant influence on health, psychological, and emotional status, tolerance, and work capacity. The first and most important of these factors is weightlessness, the most specific and radical change in the ambient environment; it causes a variety of functional and structural changes in human physiology. The second group of factors precludes the constraints associated with living in the sealed, confined environment of spacecraft. Although these factors are not unique to space flight, the limitations they entail in terms of an uncomfortable environment can diminish the well-being and performance of crewmembers in space. The third group of factors includes the occupational and social factors associated with the difficult, critical nature of the

  18. Presence and biological activity of antibiotics used in fuel ethanol and corn co-product production.

    Science.gov (United States)

    Compart, D M Paulus; Carlson, A M; Crawford, G I; Fink, R C; Diez-Gonzalez, F; Dicostanzo, A; Shurson, G C

    2013-05-01

    Antibiotics are used in ethanol production to control bacteria from competing with yeast for nutrients during starch fermentation. However, there is no published scientific information on whether antibiotic residues are present in distillers grains (DG), co-products from ethanol production, or whether they retain their biological activity. Therefore, the objectives of this study were to quantify concentrations of various antibiotic residues in DG and determine whether residues were biologically active. Twenty distillers wet grains and 20 distillers dried grains samples were collected quarterly from 9 states and 43 ethanol plants in the United States. Samples were analyzed for DM, CP, NDF, crude fat, S, P, and pH to describe the nutritional characteristics of the samples evaluated. Samples were also analyzed for the presence of erythromycin, penicillin G, tetracycline, tylosin, and virginiamycin M1, using liquid chromatography and mass spectrometry. Additionally, virginiamycin residues were determined, using a U.S. Food and Drug Administration-approved bioassay method. Samples were extracted and further analyzed for biological activity by exposing the sample extracts to 10(4) to 10(7) CFU/mL concentrations of sentinel bacterial strains Escherichia coli ATCC 8739 and Listeria monocytogenes ATCC 19115. Extracts that inhibited bacterial growth were considered to have biological activity. Physiochemical characteristics varied among samples but were consistent with previous findings. Thirteen percent of all samples contained low (≤1.12 mg/kg) antibiotic concentrations. Only 1 sample extract inhibited growth of Escherichia coli at 10(4) CFU/mL, but this sample contained no detectable concentrations of antibiotic residues. No extracts inhibited Listeria monocytogenes growth. These data indicate that the likelihood of detectable concentrations of antibiotic residues in DG is low; and if detected, they are found in very low concentrations. The inhibition in only 1 DG

  19. Use of sanitizing products: safety practices and risk situations

    Directory of Open Access Journals (Sweden)

    Ana Aurélia Rocha da Silva

    2014-04-01

    Full Text Available OBJECTIVES: to evaluate the handling and risk factors for poisoning and/or digestive tract injuries associated with the use of sanitizing products at home. METHODS: interviews were conducted in 419 households from different regions, collecting epidemiological data from residents and risk habits related to the use and storage of cleaning products. RESULTS: sanitizing products considered to be a health risk were found in 98% of the households where the research was conducted, and in 54% of cases, they were stored in places easily accessible to children. Lye was found in 19%, followed by illicit products in 39% of homes. In 13% of households, people produced soap, and in 12% they stored products in non-original containers. The use of illicit products and the manufacture of handmade soap were associated with lower educational level of the household owners and with the regions and socioeconomic classes with lower purchasing power. CONCLUSIONS: risk practices such as inadequate storage, manufacturing, and use of sanitizing products by the population evidence the need for public health policies, including educational measures, as a means of preventing accidents.

  20. Safety and efficacy of health supplement (Pegaga based product

    Directory of Open Access Journals (Sweden)

    Firdaus Abd Rahman

    2016-01-01

    Conclusions: Most traditional products claim contained herbs and have many indication although not proven by evidence based. Hence, consumers must be more selective before buying any health products. MOH continuing demonstrate enforcement action and educating the public in this matter. More research also must be conducted to confirm the efficacy and the appropriate dose for a particular situation either for prevention or treatment of disease.

  1. Research on Protection of the Agricultural Products Quality Safety based on Evolution Game from the Perspective of the Supply Chain

    Directory of Open Access Journals (Sweden)

    Ying Ma

    2013-02-01

    Full Text Available This study firstly introduces the research status quo to protect the agricultural products quality safety. Secondly, the game model is established to ensure the agricultural products quality safety, respectively, analyzed from the horizontal relations and the vertical relationships in the supply chain of agricultural products. Finally, on the basis of the analysis model, measures to protect the agricultural products quality safety are proposed, the study shows that increasing government regulations of enterprises in the supply chain of agricultural products and giving full play to the supervision and guidance role of the media and consumers will help to ensure the agricultural products quality safety.

  2. 76 FR 4847 - Hazardous Materials: Safety Requirements for External Product Piping on Cargo Tanks Transporting...

    Science.gov (United States)

    2011-01-27

    ...: Safety Requirements for External Product Piping on Cargo Tanks Transporting Flammable Liquids AGENCY... flammable liquids in unprotected external product piping on DOT specification cargo tank motor vehicles. If... specification cargo tank motor vehicle (CTMV), unless the vehicle is equipped with bottom damage...

  3. 76 FR 14643 - Hazardous Materials: Safety Requirements for External Product Piping on Cargo Tanks Transporting...

    Science.gov (United States)

    2011-03-17

    ...: Safety Requirements for External Product Piping on Cargo Tanks Transporting Flammable Liquids AGENCY... external product piping (wetlines) on a cargo tank motor vehicle (CTMV) unless the CTMV is equipped with... National Tank Truck Carriers, Inc., and the Tank Truck Manufacturers Association requesting an extension...

  4. Clinically relevant safety issues associated with St. John's wort product labels

    Directory of Open Access Journals (Sweden)

    Rutledge Jennifer C

    2008-07-01

    Full Text Available Abstract Background St. John's wort (SJW, used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Methods Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin, contraindications (bipolar disorder, therapeutic duplication (antidepressants, and general considerations (phototoxicity and advice to consult a healthcare professional (HCP. A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Results Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1% provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%, SJW-immunosupressants (5.4%, SJW-OCPs (8.1%, SJW-warfarin (5.4%, bipolar (1.4%, antidepressants (23.0%, phototoxicity (51.4%, and consult HCP (87.8%. Other safety-related information on labels included warnings about pregnancy (74.3%, lactation (64.9%, discontinue if adverse reaction (23.0%, and not for use in patients under 18 years old (13.5%. The average number of a priori safety issues included on a product label was 1.91 (range 0–8 for 23.9% completeness. Conclusion The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-07-01

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

  6. Safety evaluation in the development of medical devices and combination products

    CERN Document Server

    Gad, Shayne C

    2008-01-01

    Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field.The Third Edition explores these key current trends:global device marketscontinually advancing technologythe increasing harmonization of device safety regulation worldwideEach aspect of safety evaluation is considered in ter

  7. Modelling of Safety Factors in the Design of GRP Composite Products

    DEFF Research Database (Denmark)

    Babu, B.J.C.; Prabhakaran, R.T. Durai; Lystrup, Aage

    2010-01-01

    An attempt has been made in this paper to arrive at the safety factor design of glass fibre reinforced polymer (GRP) composite products using graph theoretic model. In the conventional design and recommendations of the standards, these design factors affecting properties have been considered as i...... that the proposed overall factor of safety is an appropriate and comprehensive measure of factor of safety. The proposed methodology is illustrated for a typical resin transfer moulded (RTM) fume hood. The concept can easily be extended for other applications....

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

    Science.gov (United States)

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

    2011-10-01

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

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    Abdalla A

    2017-03-01

    Full Text Available Abuelmagd Abdalla, Niamh Byrne, Richard Conway, Thomas Walsh, Geraldine Mannion, Michael Hanly, Miriam O’Sullivan, Ann Maria Curran, John J Carey Department of Rheumatology, Galway University Hospitals, Galway, Ireland Purpose: To evaluate the efficacy and safety of the biosimilar infliximab in adult patients with inflammatory arthritis switched from reference product in our center. Patients and methods: In April 2014, patients attending our rheumatology service for infliximab infusions were switched from reference product to the biosimilar infliximab following consent and hospital approval. Results: Around 34 patients with inflammatory arthritis were switched from reference product to biosimilar infliximab in 2014: 50% female, mean age 55 years (standard deviation=12.9, mean disease duration 14.79 years (9.7, median duration on infliximab 57 months, and two-thirds on oral disease-modifying antirheumatic drugs. There was no difference in efficacy or safety in the first 6 months of therapy. By the end of 2015, the mean follow-up on biosimilar infliximab was 15.8 (standard deviation=6.3 months. Our results showed no significant difference in Health Assessment Questionnaire score, patient global assessment of disease activity, number of disease flares, or the medication dose between the originator and the biosimilar infliximab. However, reported pain and C-reactive protein values were significantly higher during the longer follow-up period (p=0.043, 0.001 respectively. There was no significant difference in the number of adverse events or infusion reactions during follow-up periods. Only five (14.7% patients discontinued the biosimilar infliximab. Conclusion: Our patients experienced similar efficacy and safety for managing their arthritis with the biosimilar infliximab as the reference product infliximab, but at a much lower cost. Keywords: biologic therapy, rheumatic diseases, biosimilar exchange, infliximab, adult

  11. SAFETY

    CERN Multimedia

    M. Plagge, C. Schaefer and N. Dupont

    2013-01-01

    Fire Safety – Essential for a particle detector The CMS detector is a marvel of high technology, one of the most precise particle measurement devices we have built until now. Of course it has to be protected from external and internal incidents like the ones that can occur from fires. Due to the fire load, the permanent availability of oxygen and the presence of various ignition sources mostly based on electricity this has to be addressed. Starting from the beam pipe towards the magnet coil, the detector is protected by flooding it with pure gaseous nitrogen during operation. The outer shell of CMS, namely the yoke and the muon chambers are then covered by an emergency inertion system also based on nitrogen. To ensure maximum fire safety, all materials used comply with the CERN regulations IS 23 and IS 41 with only a few exceptions. Every piece of the 30-tonne polyethylene shielding is high-density material, borated, boxed within steel and coated with intumescent (a paint that creates a thick co...

  12. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont

    2013-01-01

      “Safety is the highest priority”: this statement from CERN is endorsed by the CMS management. An interpretation of this statement may bring you to the conclusion that you should stop working in order to avoid risks. If the safety is the priority, work is not! This would be a misunderstanding and misinterpretation. One should understand that “working safely” or “operating safely” is the priority at CERN. CERN personnel are exposed to different hazards on many levels on a daily basis. However, risk analyses and assessments are done in order to limit the number and the gravity of accidents. For example, this process takes place each time you cross the road. The hazard is the moving vehicle, the stake is you and the risk might be the risk of collision between both. The same principle has to be applied during our daily work. In particular, keeping in mind the general principles of prevention defined in the late 1980s. These principles wer...

  13. [Safety evaluation of food from transgenic fish and the molecular biological mechanism].

    Science.gov (United States)

    Zhang, Xichun; Yang, Xiaoguang

    2004-03-01

    More progresses have been made in the studying of transgenic fish in China, but the studying work of safety evaluation of food from transgenic fish are started up just now. Compared to plants and animals on the land, it is more difficult to control the mobility of fish and fish can give birth to a large number of offsprings, so the ecological risk or hazard about transgenic fish is more critical than others. Another safety problem is the chimerism which is initiated by the gene transfer methods used in the transgenic fish. Getting sterile triploid transgenic fish and fixed point integration are efficient to solve the two problems above respectively. The solution of the two problems are also the basis of safety evaluation and detection of food from transgenic fish. Up to now, there are little reports on the safety evaluation of transgenic fish including nutritional evaluation and allergic reaction, and there are no basic research on the detection of transgenic fish for the aim of food safety. In brief, it is very urgent to start up the research on the safety evaluation and detection of transgenic fish for the control of food safety.

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

    Directory of Open Access Journals (Sweden)

    Maristella Rubbiani

    2010-01-01

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

  15. Incorporation of occupational health and safety in cleaner production projects in South Africa

    DEFF Research Database (Denmark)

    Hedlund, Frank Huess

    2002-01-01

    occupational health and safety into the environmental activities that take place at company level. Two ways of doing so are explored, the main distinction being company size. For large companies, integration of management systems may be attractive. For small companies, integration into a less formal network......The purpose of this research is to reveal ways in which occupational health and safety can be integrated in environmental cleaner production projects. Of particular interest are those cleaner production projects that are run by the Danish government's environmental assistance agency, Danced...

  16. Off-label biologic regimens in psoriasis: a systematic review of efficacy and safety of dose escalation, reduction, and interrupted biologic therapy.

    Directory of Open Access Journals (Sweden)

    Elizabeth A Brezinski

    Full Text Available OBJECTIVES: While off-label dosing of biologic treatments may be necessary in selected psoriasis patients, no systematic review exists to date that synthesizes the efficacy and safety of these off-label dosing regimens. The aim of this systematic review is to evaluate efficacy and safety of off-label dosing regimens (dose escalation, dose reduction, and interrupted treatment with etanercept, adalimumab, infliximab, ustekinumab, and alefacept for psoriasis treatment. DATA SOURCES AND STUDY SELECTION: We searched OVID Medline from January 1, 1990 through August 1, 2011 for prospective clinical trials that studied biologic therapy for psoriasis treatment in adults. Individual articles were screened for studies that examined escalated, reduced, or interrupted therapy with etanercept, adalimumab, infliximab, ustekinumab, or alefacept. DATA SYNTHESIS: A total of 23 articles with 12,617 patients matched the inclusion and exclusion criteria for the systematic review. Data were examined for primary and secondary efficacy outcomes and adverse events including infections, malignancies, cardiovascular events, and anti-drug antibodies. The preponderance of data suggests that continuous treatment with anti-TNF agents and anti-IL12/23 agent was necessary for maintenance of disease control. Among non-responders, dose escalation with etanercept, adalimumab, ustekinumab, and alefacept typically resulted in greater efficacy than standard dosing. Dose reduction with etanercept and alefacept resulted in reduced efficacy. Withdrawal of the examined biologics led to an increase in disease activity; efficacy from retreatment did not result in equivalent initial response rates for most biologics. Safety data on off-label dosing regimens are limited. CONCLUSION: Dose escalation in non-responders generally resulted in increased efficacy in the examined biologics used to treat moderate-to-severe psoriasis. Continuous treatment with anti-TNF agents and anti-IL12/23 agent

  17. 75 FR 47605 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological..., Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends...

  18. Physicochemical and biological comparison of the first Brazilian biosimilar filgrastim with its reference product

    Directory of Open Access Journals (Sweden)

    Mantovani M

    2016-08-01

    Full Text Available Monique Mantovani,1,2 Cecilia Sulzbacher Caruso,1 Fernanda Dell Antonio Facchini,1 Renata Pascon,1,3 Patrícia Ribeiro Vilaça Cagnacci,1 Vanda Dolabela de Magalhães1 1Department of Biotechnology, Eurofarma Laboratórios SA, São Paulo, SP, Brazil; 2Libbs Farmacêutica Ltda, Embu das Artes, SP, Brazil; 3Department of Biological Sciences, Federal University of São Paulo, Diadema, SP, Brazil Abstract: The registration of biosimilars requires comparison studies to reference products to guarantee their safety, purity, efficacy, and potency. In this study, we demonstrate the similarity of a filgrastim produced by Eurofarma (Fiprima® and one produced by Amgen Inc. (commercialized by Hoffman-La Roche Ltd, Granulokine® in terms of drug identity, structure, purity, and bioactivity. The methods used to compare both products were the following: peptide mapping, bidimensional electrophoresis, reduced and nonreduced polyacrylamide electrophoresis, Western blotting, reverse-phase high-performance liquid chromatography, size-exclusion high-performance liquid chromatography, far and near circular dichroism, fluorescence emission, X-ray crystallography, liquid chromatography–tandem mass spectrometry, matrix-assisted laser desorption/ionization-time of flight, receptor binding, and potency by in vitro cell proliferation. Biosimilarity to Granulokine was demonstrated in terms of identity, structure, purity, and bioactivity. Keywords: filgrastim, biosimilar, biopharmaceutical, G-CSF, comparability, neutropenia

  19. Development of biological platform for the autotrophic production of biofuels

    Science.gov (United States)

    Khan, Nymul

    The research described herein is aimed at developing an advanced biofuel platform that has the potential to surpass the natural rate of solar energy capture and CO2 fixation. The underlying concept is to use the electricity from a renewable source, such as wind or solar, to capture CO 2 via a biological agent, such as a microbe, into liquid fuels that can be used for the transportation sector. In addition to being renewable, the higher rate of energy capture by photovoltaic cells than natural photosynthesis is expected to facilitate higher rate of liquid fuel production than traditional biofuel processes. The envisioned platform is part of ARPA-E's (Advanced Research Projects Agency - Energy) Electrofuels initiative which aims at supplementing the country's petroleum based fuel production with renewable liquid fuels that can integrate easily with the existing refining and distribution infrastructure (http://arpae. energy.gov/ProgramsProjects/Electrofuels.aspx). The Electrofuels initiative aimed to develop liquid biofuels that avoid the issues encountered in the current generation of biofuels: (1) the reliance of biomass-derived technologies on the inefficient process of photosynthesis, (2) the relatively energy- and resource-intensive nature of agronomic processes, and (3) the occupation of large areas of arable land for feedstock production. The process proceeds by the capture of solar energy into electrical energy via photovoltaic cells, using the generated electricity to split water into molecular hydrogen (H2) and oxygen (O2), and feeding these gases, along with carbon dioxide (CO2) emitted from point sources such as a biomass or coal-fired power plant, to a microbial bioprocessing platform. The proposed microbial bioprocessing platform leverages a chemolithoautotrophic microorganism (Rhodobacter capsulatus or Ralstonia eutropha) naturally able to utilize these gases as growth substrates, and genetically modified to produce a triterpene hydrocarbon fuel

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

    Science.gov (United States)

    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.

  1. EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology

    DEFF Research Database (Denmark)

    Dixon, William G; Carmona, Loreto; Finckh, Axel;

    2010-01-01

    upon safety data generated from observational drug registers makes it important to convert the lessons learned from such registers into recommendations for rheumatologists embarking upon the establishment of future registers, or analysing and reporting from new and existing registers....

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

    Science.gov (United States)

    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…

  3. 75 FR 17929 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-04-08

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... circovirus type 1 (PCV 1) in Rotarix, a U.S. licensed vaccine manufactured by GlaxoSmithKline and...

  4. 75 FR 2876 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-19

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... selection of strains to be included in the influenza virus vaccine for the 2010 - 2011 influenza season....

  5. 76 FR 44016 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-22

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological..., Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review,...

  6. 76 FR 55397 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-07

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological... the Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research...

  7. 77 FR 42319 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-07-18

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... lines derived from human tumors for vaccine manufacture. FDA intends to make background...

  8. 76 FR 3639 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-01-20

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... selection of strains to be included in the influenza virus vaccine for the 2011-2012 influenza season....

  9. 78 FR 60884 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-02

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological... of Retroviruses and Laboratory of Immunoregulation, Division of Viral Products, Office of...

  10. 77 FR 63839 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... immunogenicity of an Influenza A (H5N1) Virus Monovalent Vaccine manufactured by GlaxoSmithKline. On November...

  11. 78 FR 20663 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-04-05

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological... DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for...

  12. 78 FR 5465 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-01-25

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... strains to be included in the influenza virus vaccine for the 2013- 2014 influenza season. FDA intends...

  13. 75 FR 61497 - Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request...

    Science.gov (United States)

    2010-10-05

    ... HUMAN SERVICES Food and Drug Administration Approval Pathway for Biosimilar and Interchangeable...'' (biosimilar) to, or ``interchangeable'' with, an FDA-licensed biological product. The purpose of this public... for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed...

  14. 78 FR 19492 - Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product...

    Science.gov (United States)

    2013-04-01

    ... and Biosimilar Biological Product Sponsors or Applicants; Availability AGENCY: Food and Drug... availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar... biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the...

  15. Coal mine safety production forewarning based on improved BP neural network

    Institute of Scientific and Technical Information of China (English)

    Wang Ying; Lu Cuijie; Zuo Cuiping

    2015-01-01

    Firstly, the early warning index system of coal mine safety production was given from four aspects as per-sonnel, environment, equipment and management. Then, improvement measures which are additional momentum method, adaptive learning rate, particle swarm optimization algorithm, variable weight method and asynchronous learning factor, are used to optimize BP neural network models. Further, the models are applied to a comparative study on coal mine safety warning instance. Results show that the identification precision of MPSO-BP network model is higher than GBP and PSO-BP model, and MPSO-BP model can not only effectively reduce the possibility of the network falling into a local minimum point, but also has fast convergence and high precision, which will provide the scientific basis for the forewarning management of coal mine safety production.

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

    Science.gov (United States)

    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. Hydrological structure and biological productivity of the tropical Indian Ocean

    Digital Repository Service at National Institute of Oceanography (India)

    Muraleedharan, U.D.; Muraleedharan, P.M.

    Hydrological structure analyses of regions in the tropical Atlantic Ocean have consistently revealed the existence of a typical tropical structure characterized by a nitrate-depleted mixed layer above the thermocline. The important biological...

  18. Plans Favor Product Preferencing To Tame Spending on Biologics.

    Science.gov (United States)

    Silverman, Ed

    2016-07-01

    Historically, it's rare for commercial payers to have drug formularies for medical benefits, but that's changing. In effect, health plans are, in some ways, choosing drugs they prefer, based on their judgments about safety and efficacy, as well as availability, lowest net cost, and how a drug is administered.

  19. Control of biological hazards in cold smoked salmon production

    DEFF Research Database (Denmark)

    Huss, Hans Henrik; Embarek, Peter Karim Ben; Jeppesen, V.F.

    1995-01-01

    An outline of the common processing technology for cold smoked salmon in Denmark is presented. The safety hazards related to pathogenic bacteria, parasites and biogenic amines are discussed with special emphasis on hazards related to Clostridium botulinum and Listeria monocytogenes. Critical...

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

    Science.gov (United States)

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

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

  1. 安全文化与施工企业安全生产之我见%Views on safety culture and safety production of construction enterprises

    Institute of Scientific and Technical Information of China (English)

    张新龙

    2014-01-01

    Taking the safety culture as the core-starting from the human orientation,the paper explores the safety culture construction and safety management methods of construction enterprises,describes relationship needing coordinated in safety culture construction,and shows strategies of improving enterprise safety management level,which has significant meaning for realizing safety production of the construction enterprises.%以安全文化的核心---以人为本为切入点,对施工企业安全文化建设与安全管理方法进行了探讨,阐述了安全文化建设应协调的三方面关系,给出了提升企业安全管理水平的策略,指出建设企业安全文化对实现安全生产具有重要的意义。

  2. Trustworthy Variant Derivation with Translation Validation for Safety Critical Product Lines

    DEFF Research Database (Denmark)

    Iosif-Lazăr, Alexandru Florin; Wasowski, Andrzej

    2016-01-01

    Software product line (SPL) engineering facilitates development of entire families of software products with systematic reuse. Model driven SPLs use models in the design and development process. In the safety critical domain, validation of models and testing of code increases the quality of the p......Software product line (SPL) engineering facilitates development of entire families of software products with systematic reuse. Model driven SPLs use models in the design and development process. In the safety critical domain, validation of models and testing of code increases the quality...... translation validation. We demonstrate it using Featherweight VML—a core language for separate variability modeling relying on a single kind of variation point to define transformations of artifacts seen as object models. We use Featherweight VML with its semantics as a correctness specification...

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

    Science.gov (United States)

    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.

  4. Assessing the food safety concepts within the dairy production chain: an application of conjoint analysis

    NARCIS (Netherlands)

    Valeeva, N.I.; Meuwissen, M.P.M.; Huirne, R.B.M.

    2003-01-01

    Conjoint analysis was performed in the Dutch dairy chain to obtain the relative contribution to increased food safety of more than 100 attributes. Results from the conjoint analysis show among others that 'chemical hazards procedures and instructions for compound feed production' and 'quality assura

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

    NARCIS (Netherlands)

    Oses, 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 manageme

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

    Science.gov (United States)

    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…

  7. Productive Safety Net Program and Children's Time Use Between Work and Schooling in Ethiopia

    NARCIS (Netherlands)

    Woldehanna, T.

    2010-01-01

    Government, non-government, and donor organizations have developed a social assistance program known as Productive Safety Net Program (PSNP) which has two sub-programs namely public work program (PWP) and Direct Support Program (DSP). PSNP is designed to reduce the vulnerability of poor people to dr

  8. Biophysics and Molecular Biology of Cardiac Ion Channels for the Safety Pharmacologist.

    Science.gov (United States)

    Pugsley, Michael K; Curtis, Michael J; Hayes, Eric S

    2015-01-01

    Cardiac safety pharmacology is a continuously evolving discipline that uses the basic principles of pharmacology in a regulatory-driven process to generate data to inform risk/benefit assessment of a new chemical entity (NCE). The aim of cardiac safety pharmacology is to characterise the pharmacodynamic/pharmacokinetic (PK/PD) relationship of a drug's adverse effects on the heart using continuously evolving methodology. Unlike Toxicology, safety pharmacology includes within its remit a regulatory requirement to predict the risk of rare cardiotoxic (potentially lethal) events such as torsades de pointes (TdP), which is statistically associated with drug-induced changes in the QT interval of the ECG due to blockade of I Kr or K v11.1 current encoded by hERG. This gives safety pharmacology its unique character. The key issues for the safety pharmacology assessment of a drug on the heart are detection of an adverse effect liability, projection of the data into safety margin calculation and clinical safety monitoring. This chapter will briefly review the current cardiac safety pharmacology paradigm outlined in the ICH S7A and ICH S7B guidance documents and the non-clinical models and methods used in the evaluation of new chemical entities in order to define the integrated risk assessment for submission to regulatory authorities. An overview of how the present cardiac paradigm was developed will be discussed, explaining how it was based upon marketing authorisation withdrawal of many non-cardiovascular compounds due to unanticipated proarrhythmic effects. The role of related biomarkers (of cardiac repolarisation, e.g. prolongation of the QT interval of the ECG) will be considered. We will also provide an overview of the 'non-hERG-centric' concepts utilised in the evolving comprehensive in vitro proarrhythmia assay (CIPA) that details conduct of the proposed ion channel battery test, use of human stem cells and application of in silico models to early cardiac safety

  9. The Effect of Cocoa Beans Heavy and Trace Elements on Safety and Stability of Confectionery Products

    Directory of Open Access Journals (Sweden)

    Vītola Vineta

    2016-06-01

    Full Text Available The aim of the study was to evaluate cocoa beans quality produced in Cameroon, Ecuador, Nigeria and Ghana from safety position determining heavy and trace metals concentration and evaluating the oxidative stability of confectionery products prototypes (trials with analysing cocoa beans. For evaluation of oxidative stability of confectionery products, the main ingredients - butter and cocoa beans kernels were tested making trials as milk chocolate prototype.

  10. 9 CFR 113.52 - Requirements for cell lines used for production of biologics.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Requirements for cell lines used for production of biologics. 113.52 Section 113.52 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... STANDARD REQUIREMENTS Ingredient Requirements § 113.52 Requirements for cell lines used for production...

  11. Advancement in bioprocess technology: parallels between microbial natural products and cell culture biologics.

    Science.gov (United States)

    Bandyopadhyay, Arpan A; Khetan, Anurag; Malmberg, Li-Hong; Zhou, Weichang; Hu, Wei-Shou

    2017-02-09

    The emergence of natural products and industrial microbiology nearly eight decades ago propelled an era of bioprocess innovation. Half a century later, recombinant protein technology spurred the tremendous growth of biologics and added mammalian cells to the forefront of industrial producing cells in terms of the value of products generated. This review highlights the process technology of natural products and protein biologics. Despite the separation in time, there is a remarkable similarity in their progression. As the new generation of therapeutics for gene and cell therapy emerges, its process technology development can take inspiration from that of natural products and biologics.

  12. The potential of plants as a system for the development and production of human biologics [version 1; referees: 3 approved

    Directory of Open Access Journals (Sweden)

    Qiang Chen

    2016-05-01

    Full Text Available The growing promise of plant-made biologics is highlighted by the success story of ZMapp™ as a potentially life-saving drug during the Ebola outbreak of 2014-2016. Current plant expression platforms offer features beyond the traditional advantages of low cost, high scalability, increased safety, and eukaryotic protein modification. Novel transient expression vectors have been developed that allow the production of vaccines and therapeutics at unprecedented speed to control potential pandemics or bioterrorism attacks. Plant-host engineering provides a method for producing proteins with unique and uniform mammalian post-translational modifications, providing opportunities to develop biologics with increased efficacy relative to their mammalian cell-produced counterparts. Recent demonstrations that plant-made proteins can function as biocontrol agents of foodborne pathogens further exemplify the potential utility of plant-based protein production. However, resolving the technical and regulatory challenges of commercial-scale production, garnering acceptance from large pharmaceutical companies, and obtaining U.S. Food and Drug Administration approval for several major classes of biologics are essential steps to fulfilling the untapped potential of this technology.

  13. Patient care in a biological safety level-4 (BSL-4) environment.

    Science.gov (United States)

    Marklund, LeRoy A

    2003-06-01

    The greatest threats to America's public health include accidental importation of deadly diseases by international travelers and the release of biologic weapons by our adversaries. The greatest failure is unpreparedness because international travel and dispersion of biologic agents by our enemies are inevitable. An effective medical defense program is the recommended deterrent against these threats. The United States has a federal response plan in place that includes patient care and patient transport by using the highest level of biologic containment: BSL-4. The DoD has the capability to provide intensive care for victims infected with highly infectious yet unknown biologic agents in an environment that protects the caregiver while allowing scientists to study the characteristics of these new agents and assess the effectiveness of treatment. Army critical care nurses are vital in the biologic medical defense against unidentified infectious diseases, accidental occupational exposures, or intentional dispersion of weaponized biologic agents. Research that carefully advances healthcare using BSL-4 technology addresses the challenges of the human element of BSL-4 containment patient care, and BSL-4 patient transport enhances our nation's ability to address the emerging biologic threats we confront in the future.

  14. Progress in Biological Effects and Safety Assessment of Nanomaterials%纳米材料生物效应研究和安全性评价前沿

    Institute of Scientific and Technical Information of China (English)

    刘元方; 陈欣欣; 王海芳

    2011-01-01

    The sustainable development of nanotechnology requires the comprehensive understanding on the safety of nanomaterials. Since 2004, researches on the biological effects and safety evaluation of nanomaterials have been developing rapidly and grown to an interdisciplinary field, nanotoxicology. The safety issue of nanotechnology attracts the attentions of the academic, enterprise, government and public. The authors described the urgency and importance of safety evaluation on nanomaterials, and focused on the latest progress related to nano-product, workplace and environment. In addition, a brief discussion on the standardization in nanotechnology, the nano-ethics and the risk management of nanotechnology was presented.%纳米技术持续、健康的发展要求我们了解纳米材料的安全性.2004年以来,纳米材料生物效应和安全性研究发展迅速,形成一个跨学科的研究领域,并受到政府、学界、企业和社会公众等的广泛关注.文中叙述了纳米材料安全性评估的迫切性和重要意义,重点讨论了该领域的最新发展方向,包括纳米产品、工作场所和环境的安全等,同时简单讨论了纳米标准化、纳米技术风险管理和纳米伦理研究与纳米安全性研究的关系.

  15. The occupational safety on the construction sites of the farm production buildings in Finland

    Directory of Open Access Journals (Sweden)

    M. Hellstedt

    2013-09-01

    Full Text Available The size of farms has increased considerably during Finland's EU membership. The growth has meant big investments in the new production buildings. The buildings have been switched to big industrialhall- like constructions from small-scale ones which have contained own timber and own work contribution. The objective of the project financed by Farmers' Social Insurance Institution was to improve occupational safety on farm building construction and renovation sites by disseminating current safety practices and by developing ways of action which are better than the prevailing ones. The project consisted of a literature review, statistical analysis, as well as a farmer and designer interviews. In the statistical analysis the MATA occupational injuries insurance claims database on farmers’ claims during construction and renovation work for the years 2005 - 2008 was compared with the register of Federation of Accident Insurance Institutions on the construction workers' injuries. In comparing the reasons of the accidents a clear difference was found; poor scaffoldings and ladders are still the main culprits on farm accidents. Farmer interviews were used to assess occupational safety measures on the construction site, occurred injuries and their types, nearmiss situations and the underlying factors which have led to the injuries. Also construction safety deficiencies as well as the direct and indirect costs caused for instance because of the delay in completion of construction project were discussed. Designer interviews aimed to find out how occupational safety and health considerations are taken into account in farm building planning and counseling, and how this experience of the designers should be utilized in order to improve safety at the construction sites on farms. Farmers knew their obligations on occupational safety poorly. The situation was further worsened by the fact that on the site the supervisor tasks were only nominally executed. The

  16. Safety of Animal Fats for Biodiesel Production: A Critical Review of Literature

    Energy Technology Data Exchange (ETDEWEB)

    Greene, A.; Dawson, P.; Nixon, D.; Atkins, J.; Pearl, G. [Clemson University, SC (United States)

    2007-05-15

    An in-depth review of available literature was conducted on the safety of using animal fats for biodiesel. The review indicated little or no known risk to human and animal health and to the environment relative to inherent microbial, organic or inorganic agents in animal fats destined for biodiesel production. Animal by-products are generated from the inedible tissues derived from meat, poultry and fish production. This material is thermally processed by the rendering industry to generate a number of industrial materials including use of the fat portion to produce biodiesel. As the biodiesel industry continues to develop, questions have emerged about the safety of animal versus vegetable fats for biodiesel production and utilization. The following report is the result of a detailed literature search into the potential microbial, organic, and inorganic contaminants that may be present in animal fats and the potential for human or environmental safety issues associated with each. The potential safety risks associated with prions are discussed in a separate report, 'Biodiesel from Specified Risk Material Tallow: An Appraisal of TSE Risks and their Reduction'. In certain instances, very little was reported about the potential contaminating moiety and its fate in biodiesel production and usage. Establishing an absolute zero risk assessment is impossible on any fat utilized for biodiesel production. Among the potential microbial contaminants, bacteria, viruses, fungi, yeast, parasites, and microbial toxins were considered. In each instance, the nature of the production process and usage of biodiesel via combustion reduce the possibility that microbial contaminants would be a cause for concern to humans, animals, or the environment. Potential organic moieties contaminating the fat should meet a similar fate. Current evidence suggests that metals and metalloids within animal fats will not cause significant safety issues in the production and use of rendered fat

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

    Science.gov (United States)

    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.

  18. 9 CFR 103.3 - Shipment of experimental biological products.

    Science.gov (United States)

    2010-01-01

    ... Only—Not For Sale,” or equivalent. The U.S. Veterinary License legend shall not appear on such labels... product and for maintaining records of the quantities of experimental product prepared, shipped and...

  19. 9 CFR 101.3 - Biological products and related terms.

    Science.gov (United States)

    2010-01-01

    ..., representing a whole culture or a concentrate thereof, with or without the unevaluated growth products, which... toxin or toxic growth product, which has resulted from the growth of bacterial organisms in a culture... product which is either: (1) A suspension of organisms, representing a whole culture or a...

  20. Synthetic biology for microbial production of lipid-based biofuels.

    Science.gov (United States)

    d'Espaux, Leo; Mendez-Perez, Daniel; Li, Rachel; Keasling, Jay D

    2015-12-01

    The risks of maintaining current CO2 emission trends have led to interest in producing biofuels using engineered microbes. Microbial biofuels reduce emissions because CO2 produced by fuel combustion is offset by CO2 captured by growing biomass, which is later used as feedstock for biofuel fermentation. Hydrocarbons found in petroleum fuels share striking similarity with biological lipids. Here we review synthetic metabolic pathways based on fatty acid and isoprenoid metabolism to produce alkanes and other molecules suitable as biofuels. We further discuss engineering strategies to optimize engineered biosynthetic routes, as well as the potential of synthetic biology for sustainable manufacturing.

  1. Metabolic engineering with systems biology tools to optimize production of prokaryotic secondary metabolites

    DEFF Research Database (Denmark)

    Kim, Hyun Uk; Charusanti, Pep; Lee, Sang Yup;

    2016-01-01

    for the optimal production of various prokaryotic secondary metabolites: native versus heterologous hosts (e.g., Escherichia coli) and rational versus random approaches. This comparative analysis is followed by discussions on systems biology tools deployed in optimizing the production of secondary metabolites....... The potential contributions of additional systems biology tools are also discussed in the context of current challenges encountered during optimization of secondary metabolite production....

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

    Science.gov (United States)

    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.

  3. Leading safety performance indicators for resilience assessment of radiopharmaceuticals production process

    Energy Technology Data Exchange (ETDEWEB)

    Grecco, Claudio H.S.; Santos, Isaac J.A.L.; Carvalho, Paulo V.R., E-mail: grecco@ien.gov.b, E-mail: luquetti@ien.gov.b, E-mail: paulov@ien.gov.b [Instituto de Engenharia Nuclear (IEN/CNEN-RJ), Rio de Janeiro, RJ (Brazil). Div. de Instrumentacao e Confiabilidade Humana; Vidal, Mario C.R., E-mail: mvidal@ergonomia.ufrj.b [Coordenacao dos Programas de Pos-Graduacao de Engenharia (PEP/COPPE/UFRJ), Rio de Janeiro, RJ (Brazil). Programa de Engenharia de Producao. Grupo de Ergonomia e Novas Tecnologias (GENTE)

    2011-07-01

    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-benzyl guanidine is used in the diagnosis of cardiac diseases, and the fluorodeoxyglucose is used in diagnosis in cardiology, oncology, neurology and neuro psychiatry. This paper presents a leading safety performance indicators framework to assess the resilience of radiopharmaceuticals production processes. The organizations that use resilience indicators will be able to pro actively evaluate and manage safety. (author)

  4. GRADUATION DETERMINANTS OF PRODUCTIVE SAFETY NET PROGRAM BENEFICIARY HOUSEHOLDS: A LOGISTIC ANALYSIS, TIGRAI-ETHIOPIA

    Directory of Open Access Journals (Sweden)

    Yibrah Hagos Gebresilassie

    2013-12-01

    Full Text Available Household food security issues have become the concern of international communities as well as national government of Ethiopia. Social safety nets (like Productive Safety Net Program in Ethiopia are programs that offer protection to poor rural people by providing income through transfer programs and employment opportunities. The main objective of this study was to identify the major graduation determinants of Productive safety Net Program beneficiary rural households using a logistic regression technique from a total of 400 sample respondents using Eastern zone of Tigrai regional national state, northern Ethiopia, as case study site. The researcher was initially identified about sixteen predicting factors of which just ten of them were found to be statistically significant, and all exhibited the expected signs. Regression results revealed thatan introduction to integrated agricultural package make use of, male-headed household, age squared of the household head, educational status of the household head, saving culture, male adults, non-government organizations follow-up, access to credit, access to petty trading and irrigation have led productive safety net program beneficiary households to have more probability of graduation. Finally, it is recommended that assisting farming rural households to diversify and expand their sources of income in order to be able to meet their minimum food requirement and graduate soon through the provision of integrated agricultural packages. Besides, program participants should be followed up by non-government organizations and highly engaged in petty trading to graduate sooner, boost their income and food secure.

  5. Kinetic study of biological hydrogen production by anaerobic fermentation

    Energy Technology Data Exchange (ETDEWEB)

    Sangeetha, R. [Annamalai Univ., Chidambaram (India). Dept. of Chemical Engineering; Karunanithi, T. [Annamalai Univ., Tamilnadu (India). Dept. of Chemical Engineering

    2009-07-01

    This study examined the kinetics of batch biohydrogen production from glucose. Clostridium pasteurianum was used to produce biohydrogen by dark anaerobic fermentation. The initial substrate concentration, initial pH and temperature were optimized for biohydrogen production. The maximum production of hydrogen under optimum conditions was found to be 5.376 l/l. The kinetic parameters were determined for the optimized medium and conditions in the batch reactor. The by product was expressed as total acidic equivalent. This presentation discussed the logistic equation that was used to model the growth of the organism and described how the kinetic parameters were calculated. The Leudeking piret kinetic model was used to express the hydrogen production and substrate use because it combines both growth associated and non associated contributions. It was concluded the production of biohydrogen can be predicted well using the logistic model for cell growth kinetics and the logistic incorporated Leudeking Piret model for product and substrate utilization kinetics.

  6. Importance of systems biology in engineering microbes for biofuel production

    Energy Technology Data Exchange (ETDEWEB)

    Mukhopadhyay, Aindrila; Redding, Alyssa M.; Rutherford, Becky J.; Keasling, Jay D.

    2009-12-02

    Microorganisms have been rich sources for natural products, some of which have found use as fuels, commodity chemicals, specialty chemicals, polymers, and drugs, to name a few. The recent interest in production of transportation fuels from renewable resources has catalyzed numerous research endeavors that focus on developing microbial systems for production of such natural products. Eliminating bottlenecks in microbial metabolic pathways and alleviating the stresses due to production of these chemicals are crucial in the generation of robust and efficient production hosts. The use of systems-level studies makes it possible to comprehensively understand the impact of pathway engineering within the context of the entire host metabolism, to diagnose stresses due to product synthesis, and provides the rationale to cost-effectively engineer optimal industrial microorganisms.

  7. Applied systems biology - vanillin production in Saccharomyces cerevisiae

    DEFF Research Database (Denmark)

    Strucko, Tomas; Eriksen, Jens Christian; Nielsen, J.

    2012-01-01

    Vanillin is the most important aroma compound based on market value, and natural vanillin is extracted from the cured seed pods of the Vanilla orchid. Most of the world’s vanillin, however, is obtained by chemical synthesis from petrochemicals or wood pulp lignins. As an alternative, de novo bios...... in a systems biology setting....

  8. The chemistry and biology of guanidine natural products.

    Science.gov (United States)

    Berlinck, Roberto G S; Romminger, Stelamar

    2016-03-01

    The present review discusses the isolation, structure determination, synthesis, biosynthesis and biological activities of secondary metabolites bearing a guanidine group. Topics include non-ribosomal peptides, alkaloids, guanidine-bearing terpenes, polyketides and shikimic acid derivatives from natural sources. A critical analysis of some yet underdeveloped aspects of guanidine metabolites is also presented.

  9. Biological production of alcohols from coal through indirect liquefaction

    Energy Technology Data Exchange (ETDEWEB)

    Barik, S.; Prieto, S.; Harrison, S.B.; Clausen, E.C.; Gaddy, J.L.

    1988-08-01

    The purpose of this project is to demonstrate the feasibility of producing liquid fuels from the components of synthesis gas through biological indirect liquefaction. The results of pure culture and natural source screening studies aimed at finding organisms capable of carrying out the conversions are presented and discussed. 17 refs., 2 figs., 8 tabs.

  10. Importance of Decision Support Systems About Food Safety in Raw Milk Production

    Directory of Open Access Journals (Sweden)

    Ecem Akan

    2015-12-01

    Full Text Available In raw milk production decision support systems for control of food safety hazards has not been developed but main points of this system are available. The decision support systems’ elements include data identification at critical points in the milk supply chain, an information management system and data exchange. Decision supports systems has been developed on the basis of these elements. In dairy sector decision support systems are significant for controlling of food safety hazards and preferred by producers. When these systems are implemented in the milk supply chain, it can be prevented unnecessary sampling and analysis. In this article it will be underlined effects of decision support system elements on food safety of raw milk.

  11. International Conference on Harmonisation; guidance on quality of biotechnological/biological products: derivation and characterization of cell substrates used for production of biotechnological/biological products; availability. Notice. Food and Drug Administration, HHS.

    Science.gov (United States)

    1998-09-21

    The Food and Drug Administration (FDA) is publishing a guidance entitled "Q5D Quality of Biotechnological/Biological Products:Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).The document provides broad guidance on appropriate standards for the derivation and characterization of cell substrates used in the production of biotechnological/biological products and recommends information in these areas that should be presented in marketing applications.

  12. Potential for widespread application of biological control of stored-product pests

    DEFF Research Database (Denmark)

    Hansen, Lise Stengaard

    2007-01-01

    Biological control of stored product pests has substantial potential in Europe". This is essentially the conclusion of the activities of a European working group funded by the COST system, an intergovernmental networking system. Working group 4 of COST action 842 (2000-2005) focussed on biological......, beetles and moths; (2) Preventative treatment of bulk commodities against weevils (Sitophilus spp.) and storage mites; (3) Preventative application of egg-parasitoids against moths in packaged products. Development of methods for biological control and of mass production of natural enemies...

  13. Recombinant biologic products versus nutraceuticals from plants - a regulatory choice?

    Science.gov (United States)

    Drake, Pascal M W; Szeto, Tim H; Paul, Mathew J; Teh, Audrey Y-H; Ma, Julian K-C

    2017-01-01

    Biotechnology has transformed the potential for plants to be a manufacturing source of pharmaceutical compounds. Now, with transgenic and transient expression techniques, virtually any biologic, including vaccines and therapeutics, could be manufactured in plants. However, uncertainty over the regulatory path for such new pharmaceuticals has been a deterrent. Consideration has been given to using alternative regulatory paths, including those for nutraceuticals or cosmetic agents. This review will consider these possibilities, and discuss the difficulties in establishing regulatory guidelines for new pharmaceutical manufacturing technologies.

  14. Biological processes for the production of aryl sulfates

    DEFF Research Database (Denmark)

    2016-01-01

    The present invention generally relates to the field of biotechnology as it applies to the production of aryl sulfates using polypeptides or recombinant cells comprising said polypeptides. More particularly, the present invention pertains to polypeptides having aryl sulfotransferase activity......, recombinant host cells expressing same and processes for the production of aryl sulfates employing these polypeptides or recombinant host cells....

  15. Biological production of hydroxylated aromatics: Optimization strategies for Pseudomonas putida S12

    NARCIS (Netherlands)

    Verhoef, A.

    2010-01-01

    To replace environmentally unfriendly petrochemical production processes, the demand for bio-based production of organic chemicals is increasing. This thesis focuses on the biological production of hydroxylated aromatics from renewable substrates by engineered P. putida S12 including several cases o

  16. 9 CFR 113.51 - Requirements for primary cells used for production of biologics.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Requirements for primary cells used for production of biologics. 113.51 Section 113.51 Animals and Animal Products ANIMAL AND PLANT HEALTH... VECTORS STANDARD REQUIREMENTS Ingredient Requirements § 113.51 Requirements for primary cells used...

  17. Synoptic events force biological productivity in Patagonian fjord ecosystems

    Science.gov (United States)

    Daneri, Giovanni

    2016-04-01

    The annual cycle of primary productivity of the Patagonian fjords has, to date, been described as a two phase system consisting of a short non productive winter phase (during June and July) and a productive phase extending from late winter (August) to autumn (May). Low levels of primary production, phytoplankton biomass and high concentrations of surface nutrients have been described as characterizing winter conditions while pulsed productivity events typifies the productivity pattern during the extended productive season. Pulsed productivity events characterize coastal waters where inorganic nutrients in surface layers are replenished following periods of intensive utilization by autotrophs. Freshwater input in Patagonian fjords in southern Chile (41-55°S) results in one of the largest estuarine regions worldwide. Here strong haline water column stratification prevents nutrient mixing to the surface layers thus potentially shutting off algal production. Our working hypothesis considered that in order to reconcile the observed pulsed productivity pattern, periodic breaking (associated to surface nutrient replenishment) and re-establishment of estuarine conditions (associated to water column stratification) would be required. Up to now however our understanding of the physical processes that control water column conditions in the Patagonian fjord area has been extremely limited. Here we present evidence linking the passage of synoptic low pressure fronts to pulsed productivity events in the Patagonian fjord area. These front controls and influence local processes of interaction between the fjord and the atmosphere generating a rapid water column response. In the specific case of the Puyuhuapi fjord we have been able to show that such synoptic fronts induce surface flow reversal and water column mixing. Phytoplankton blooming occurs after the passage of the synoptic front once calmer conditions prevail and estuarine conditions are re established. The occurrence of

  18. Biological pretreatment and ethanol production from olive cake

    DEFF Research Database (Denmark)

    Jurado, Esperanza; Gavala, Hariklia N.; Baroi, George Nabin

    2010-01-01

    Olive oil is one of the major Mediterranean products, whose nutritional and economic importance is well-known. However the extraction of olive oil yields a highly contaminating residue that causes serious environmental concerns in the olive oil producing countries. The olive cake (OC) coming out...... of the three-phase olive oil production process could be used as low price feedstock for lignocellulosic ethanol production due to its high concentration in carbohydrates. However, the binding of the carbohydrates with lignin may significantly hinder the necessary enzymatic hydrolysis of the polymeric sugars...

  19. What drives the biological productivity of the northern Indian Ocean?

    Digital Repository Service at National Institute of Oceanography (India)

    PrasannaKumar, S.; Narvekar, J.; Nuncio, M.; Gauns, M.; Sardessai, S.

    .g., Baars, 1994; Lal, 1994; Burkill, 1999; Smith, 1998, 1999, 2000, 2001] pro- grams saw a quantum jump in our understanding of the AS productivity. The information that emerged from the JGOFS program underscored the importance of physical forcing...

  20. 75 FR 59729 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-09-28

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological... for protective antigen-based anthrax vaccines for a post-exposure prophylaxis indication using...

  1. Strategies for optimizing algal biology for enhanced biomass production

    Directory of Open Access Journals (Sweden)

    Amanda N. Barry

    2015-02-01

    Full Text Available One of the more environmentally sustainable ways to produce high energy density (oils feed stocks for the production of liquid transportation fuels is from biomass. Photosynthetic carbon capture combined with biomass combustion (point source and subsequent carbon capture and sequestration (BECCS has also been proposed in the Intergovernmental Panel on Climate Change Report as one of the most effective and economical strategies to remediate atmospheric greenhouse gases. To maximize photosynthetic carbon capture efficiency and energy-return-on-investment, we must develop biomass production systems that achieve the greatest yields with the lowest inputs. Numerous studies have demonstrated that microalgae have among the greatest potentials for biomass production. This is in part due to the fact that all alga cells are photoautotrophic, they have active carbon concentrating mechanisms to increase photosynthetic productivity, and all the biomass is harvestable unlike plants. All photosynthetic organisms, however, convert only a fraction of the solar energy they capture into chemical energy (reduced carbon or biomass. To increase aerial carbon capture rates and biomass productivity it will be necessary to identify the most robust algal strains and increase their biomass production efficiency often by genetic manipulation. We review recent large-scale efforts to identify the best biomass producing strains and metabolic engineering strategies to improve aerial productivity. These strategies include optimization of photosynthetic light-harvesting antenna size to increase energy capture and conversion efficiency and the potential development of advanced molecular breeding techniques. To date, these strategies have resulted in up to two-fold increases in biomass productivity.

  2. Sustainable Production Process of Biological Mineral Feed Additives

    OpenAIRE

    Agnieszka Zielinska; Katarzyna Chojnacka; Marjana Simonic

    2009-01-01

    Problem statement: This study discussed the problem of accumulation of Zn and Cu in the topsoil as a result of application of mineral feed additives that possess low bioavailability in animal diet. The review considered the production process of mineral feed additives in which a product supplies microelements in highly bioavailable form. Enrichment of natural biomass of edible microalgae with microelement metal ions, which supply microelements of feeding significance in livestock diet, is con...

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

    Science.gov (United States)

    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'.

  4. Quality and safety assessment of meat products obtained by traditional romanian recipes

    Directory of Open Access Journals (Sweden)

    Adriana Morar

    2016-05-01

    Full Text Available Meat products obtained following traditional recipes are considered healthy foods, with superior sensory characteristics, being highly appreciated by consumers. This study aimed to evaluate the quality and safety of 18 meat products obtained by traditional receipts, including raw/smoked pork sausages (n=3, loin (n=1, bacon (n=2, kaizer (n=1, ham (n=1, spareribs (n=1, pork pastrami (n=1, and sausages prepared from edible meat offal of pork (n=8. All samples were bacteriologically examined (Salmonella, L. monocytogenes and E. coli. Also, moisture, fat, total protein, salt and nitrite contents were quantified. All products were Salmonella and L. monocytogenes free. E. coli was recovered in two samples (11.1%, a smoked pork sausage and a sausage prepared from edible meat offal of pork, at levels between 1.5 log and 3.25 log cfu/g. Moisture ranged from 17.21 to 67.46%, fat 17.37–62.18%, protein 8.13–23.18%, sodium chloride 1.50–6.39%, and nitrites <10–35 ppm, respectively. In two samples (11.1% of smoked meat products the salt content exceeded the maximum limits allowed by law. These results have shown that meat products obtained by traditional recipes are nutritive and safety. However, some varieties of meat products with high salt concentrations should be avoided by persons with dietary salt restriction.

  5. Some aspects of biological production and fishery resources of the EEZ of India

    Digital Repository Service at National Institute of Oceanography (India)

    Bhargava, R.M.S.

    Region and season-wise biological production in the Exclusive Economic Zone (EEZ) of India has been computed from the data of more than twenty years available at the Indian National Oceanographic Data Centre of the National Institute of Oceanography...

  6. Evaluation of hygiene and safety criteria in the production of a traditional Piedmont cheese

    Directory of Open Access Journals (Sweden)

    Sara Astegiano

    2014-08-01

    Full Text Available 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.

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

    Science.gov (United States)

    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.

  8. Sustainable Production Process of Biological Mineral Feed Additives

    Directory of Open Access Journals (Sweden)

    Agnieszka Zielinska

    2009-01-01

    Full Text Available Problem statement: This study discussed the problem of accumulation of Zn and Cu in the topsoil as a result of application of mineral feed additives that possess low bioavailability in animal diet. The review considered the production process of mineral feed additives in which a product supplies microelements in highly bioavailable form. Enrichment of natural biomass of edible microalgae with microelement metal ions, which supply microelements of feeding significance in livestock diet, is considered in term of sustainable production. Approach: Production of microalgae-derived products as mineral feed additives requires elaboration of the processes for cultivation of alga, enrichment process and afterwards recovery of the enriched biomass from the solution to obtain liquid free of cells that could be reused in the next process. In this study membrane bioreactor was considered as a method for separation, both in photobioreactor (growth of microorganism as well as in the enrichment process. Results: Effort involved in thermal and chemical separation techniques is higher than that in mechanical techniques. Membrane bioreactors which are usually applied to treat wastewater, both industrial and domestic. This study discussed method to separate a valuable biomass of enriched microalgae and reuse the solution with residual metal ions that can be used once again in the subsequent biosorption process. Conclusion/Recommendation: Taking into consideration care about the environment it is better to apply membrane modules in the production process in terms of sustainable production. The proposed solution assumed the application of membrane modules as a separation step after enrichment process and biomass recovery.

  9. International Conference on Harmonisation; guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process; availability. Notice.

    Science.gov (United States)

    2005-06-30

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The purpose of the guidance is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product. The guidance is intended to assist in the collection of relevant technical information that serves as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety, and efficacy of the drug product.

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

    Science.gov (United States)

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

    2009-01-01

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

  11. Recent advances in biological production of sugar alcohols.

    Science.gov (United States)

    Park, Yong-Cheol; Oh, Eun Joong; Jo, Jung-Hyun; Jin, Yong-Su; Seo, Jin-Ho

    2016-02-01

    Sugar alcohols, such as xylitol, mannitol, sorbitol, and erythritol are emerging food ingredients that provide similar or better sweetness/sensory properties of sucrose, but are less calorigenic. Also, sugar alcohols can be converted into commodity chemicals through chemical catalysis. Biotechnological production offers the safe and sustainable supply of sugar alcohols from renewable biomass. In contrast to early studies that aimed to produce sugar alcohols with microorganisms capable of producing sugar alcohols naturally, recent studies have focused on rational engineering of metabolic pathways to improve yield and productivity as well as to use inexpensive and abundant substrates. Metabolic engineering strategies to utilize inexpensive substrates, alleviate catabolite repression, reduce byproduct formation, and manipulate redox balances led to enhanced production of sugar alcohols.

  12. Synthetic biology tools for bioprospecting of natural products in eukaryotes.

    Science.gov (United States)

    Unkles, Shiela E; Valiante, Vito; Mattern, Derek J; Brakhage, Axel A

    2014-04-24

    Filamentous fungi have the capacity to produce a battery of natural products of often unknown function, synthesized by complex metabolic pathways. Unfortunately, most of these pathways appear silent, many in intractable organisms, and their products consequently unidentified. One basic challenge is the difficulty of expressing a biosynthesis pathway for a complex natural product in a heterologous eukaryotic host. Here, we provide a proof-of concept solution to this challenge and describe how the entire penicillin biosynthesis pathway can be expressed in a heterologous host. The method takes advantage of a combination of improved yeast in vivo cloning technology, generation of polycistronic mRNA for the gene cluster under study, and an amenable and easily manipulated fungal host, i.e., Aspergillus nidulans. We achieve expression from a single promoter of the pathway genes to yield a large polycistronic mRNA by using viral 2A peptide sequences to direct successful cotranslational cleavage of pathway enzymes.

  13. Systems-Level Synthetic Biology for Advanced Biofuel Production

    Energy Technology Data Exchange (ETDEWEB)

    Ruffing, Anne [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Jensen, Travis J. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Strickland, Lucas Marshall [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Meserole, Stephen [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Tallant, David [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2015-03-01

    Cyanobacteria have been shown to be capable of producing a variety of advanced biofuels; however, product yields remain well below those necessary for large scale production. New genetic tools and high throughput metabolic engineering techniques are needed to optimize cyanobacterial metabolisms for enhanced biofuel production. Towards this goal, this project advances the development of a multiple promoter replacement technique for systems-level optimization of gene expression in a model cyanobacterial host: Synechococcus sp. PCC 7002. To realize this multiple-target approach, key capabilities were developed, including a high throughput detection method for advanced biofuels, enhanced transformation efficiency, and genetic tools for Synechococcus sp. PCC 7002. Moreover, several additional obstacles were identified for realization of this multiple promoter replacement technique. The techniques and tools developed in this project will help to enable future efforts in the advancement of cyanobacterial biofuels.

  14. 21 CFR 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic...

    Science.gov (United States)

    2010-04-01

    ... requirements for biological products held by the Strategic National Stockpile. 610.68 Section 610.68 Food and... GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile. (a) The appropriate FDA...

  15. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Science.gov (United States)

    2010-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... drug or human biological product is eligible for extension, the term shall be extended by the time as... term of the patent for a human drug, antibiotic drug or human biological product will be extended...

  16. Traditional and regional food products in Poland and European Union – legislation and food safety

    Directory of Open Access Journals (Sweden)

    Mirosław M. Michalski

    2011-09-01

    Full Text Available The paper aims at presenting the present state of law and food safety regarding traditional/regional foods. The production has to be carried out hygienically assuring food safety to the products. Legal regulations connected with production and protection of the traditional foods arecontained in Council Regulations (EC No 509/2006 and No 510/2006. The mentioned above decrees create marking and requirement for three groups of food products: Traditional Specialities Guaranteed (TSG, Protected Designation of Origin (PDO and Protected of Geographical Indication (PGI. Manufacturers must produce this type of foodstuff according to general hygienic rules. In order to protect the consumer, they should be subject to inspection based on Commission Regulation (EC No 882/2004. Foodstuff should be subject to ensure that operators comply with the product specification before marketing. Verification of compliance with the specifications of any agricultural product and foodstuff produced within the EC shall be ensured by one or more competent verification organisation/body or/and authorities certification bodies operating as a product certification body after accreditation in accordance with European standard EN 45011 (2000. Foodstuffs should not contain microorganisms or their toxins or metabolites in quantities that present an unacceptable risk for human health. Foodstuff producers are obligated to fulfil microbiological requirements. Products should be monitored according to the national plan of monitoring, in range of residues of pesticides, heavy metals, dioxin or inhibitory substances and also controlled on permitted additives. The promotion of our traditional and regional foods is carried out by several organisations which are active in Poland, i.e. Polish Chamber of Regional and Local Products and Centre for Studies of Natural and Traditional Food (at University of Warmia and Mazury in Olsztyn.  

  17. Bovine mammary stem cells: Cell biology meets production agriculture

    Science.gov (United States)

    Mammary stem cells (MaSC) provide for net growth, renewal and turnover of mammary epithelial cells, and are therefore potential targets for strategies to increase production efficiency. Appropriate regulation of MaSC can potentially benefit milk yield, persistency, dry period management and tissue ...

  18. Improvements in Fermentative Biological Hydrogen Production Through Metabolic Engineering

    Energy Technology Data Exchange (ETDEWEB)

    Hallenbeck, P. C.; Ghosh, D.; Sabourin-Provost, G.

    2009-07-01

    Dramatically rising oil prices and increasing awareness of the dire environmental consequences of fossil fuel use, including startling effects of climate change, are refocusing attention world-wide on the search for alternative fuels. Hydrogen is poised to become an important future energy carrier. Renewable hydrogen production is pivotal in making it a truly sustainable replacement for fossil fuels. (Author)

  19. BIOLOGICAL FEATURES AND PRODUCTIVITY OF BLACK-AND-WHITE CATTLE

    Directory of Open Access Journals (Sweden)

    Kochueva Y. V.

    2015-02-01

    Full Text Available The behavior, interior and milk yield of the mature Black-and-White cows with various productivity levels, as well as etology of the replacement heifers are researched. The superiority of the high milk yielding cows for the lying duration and eating feed and water is revealed. Reduced variability of vital behavioral actions of animals is found. In addition, high yielding cows has been lower variability in all feeding acts. It was noted that high yielding animals exceeded equal age cows by the level of most interior factors. The differences were significant on the content of hemoglobin, vitamin E, and especially on the content of iron. Positive correlations between some interior design indicators is found. The analysis of lifetime productivity during our research found that high milk yielding cows had highest yields on the first lactation and kept the same level in the next lactations with insignificant variations. The lower productivity animals reached maximal yields on the third lactation with the followed downward trend. Differences between groups in lifetime productivity during research amounted to 16 992 kg. The significant superiority of the heifers with high grown intensity above equal age animals for the duration of feed and water eating, physiological functions and lying. The analysis of variation coefficient is confirmed the observed regularities.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  2. Chemical biology--identification of small molecule modulators of cellular activity by natural product inspired synthesis.

    Science.gov (United States)

    Hübel, Katja; Lessmann, Torben; Waldmann, Herbert

    2008-07-01

    The aim of this tutorial review is to introduce the reader to the concept, synthesis and application of natural product-inspired compound collections as an important field in chemical biology. This review will discuss how potentially interesting scaffolds can be identified (structural classification of natural products), synthesized in an appropriate manner (including stereoselective transformations for solid phase-bound compounds) and tested in biological assays (cell-based screening as well as biochemical in vitro assays). These approaches will provide the opportunity to identify new and interesting compounds as well as new targets for chemical biology and medicinal chemistry research.

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

    Science.gov (United States)

    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

  4. Pathogen safety of plasma-derived products - Haemate P/Humate-P.

    Science.gov (United States)

    Gröner, A

    2008-11-01

    Plasma-derived factor VIII (FVIII) and von Willebrand Factor (VWF)/FVIII concentrates have been successfully used to treat haemophilia since the late 1960s. These products are derived from pools of plasma donations that may contain viral contaminants - including hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) - and may therefore present a transmission risk to recipients. To ensure the safety of Haemate P/Humate-P, a plasma-derived VWF/FVIII concentrate, donors of plasma are carefully selected and all donations are screened for viral antigens (HBV), virus-specific antibodies (HIV-1/2, HCV) and genomic material [hepatitis A virus, HBV, HCV, HIV-1 and high titres of human parvovirus B19 (B19V)]. As a quality control measure, plasma pools for fractionation are only released for further processing when non-reactivity has been demonstrated in serological and genome amplification assays. The manufacturing process for plasma-derived products, especially the fundamental procedure of pasteurization, is effective in inactivating and/or removing a wide variety of viruses that may potentially be present despite the screening process. This has been demonstrated in virus validation studies using a range of different viruses. New emerging infectious agents, including prions, which potentially pose a threat to recipients of plasma derivatives, are also the subject of safety evaluations. The multiple precautionary measures that are inherent in the overall production process of Haemate P/Humate-P have resulted in an excellent safety record, documented during 25 years of clinical use, and will help to maintain the high safety margin in the future.

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

    Science.gov (United States)

    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. Reliability and safety of the electrical power supply complex of the Hanford production reactors

    Energy Technology Data Exchange (ETDEWEB)

    Robbins, F.D.

    1960-09-15

    Safety has been and must continue to be the inviolable modulus by which the operation of a nuclear reactor must be judged. A malfunction in any reactor may well result in a release of fission products which may dissipate over a wide geographical area. Such dissipation may place the health, happiness and even the lives of the people in the region in serious jeopardy. As a result, the property damage and liability cost may reach astronomical values in the order of magnitude of billions of dollars. Reliability of the electrical network is an indispensable factor in attaining a high order of safety assurance. Progress in the peaceful use of atomic energy may take the form of electrical power generation using the nuclear reactor as a source of thermal energy. In view of these factors it seems appropriate and profitable that a critical engineering study be made of the safety and reliability of the Hanford reactors without regard to cost economics. This individual and independent technical engineering analysis was made without regard to Hanford traditional engineering and administration assignments. The main objective has been to focus attention on areas which seem to merit further detailed study on conditions which seem to need adjustment but most of all on those changes which will improve reactor safety. This report is the result of such a study.

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

    Energy Technology Data Exchange (ETDEWEB)

    Hurt, Christopher J. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Freels, James D. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Hobbs, Randy W. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Jain, Prashant K. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Maldonado, G. Ivan [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

    2016-08-01

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

  8. A turning point for natural product discovery--ESF-EMBO research conference: synthetic biology of antibiotic production.

    Science.gov (United States)

    Takano, Eriko; Bovenberg, Roel A L; Breitling, Rainer

    2012-03-01

    Synthetic Biology is in a critical phase of its development: it has finally reached the point where it can move from proof-of-principle studies to real-world applications. Secondary metabolite biosynthesis, especially the discovery and production of antibiotics, is a particularly relevant target area for such applications of synthetic biology. The first international conference to explore this subject was held in Spain in October 2011. In four sessions on General Synthetic Biology, Filamentous Fungal Systems, Actinomyces Systems, and Tools and Host Structures, scientists presented the most recent technological and scientific advances, and a final-day Forward Look Plenary Discussion identified future trends in the field.

  9. Time-ordered product expansions for computational stochastic system biology.

    Science.gov (United States)

    Mjolsness, Eric

    2013-06-01

    The time-ordered product framework of quantum field theory can also be used to understand salient phenomena in stochastic biochemical networks. It is used here to derive Gillespie's stochastic simulation algorithm (SSA) for chemical reaction networks; consequently, the SSA can be interpreted in terms of Feynman diagrams. It is also used here to derive other, more general simulation and parameter-learning algorithms including simulation algorithms for networks of stochastic reaction-like processes operating on parameterized objects, and also hybrid stochastic reaction/differential equation models in which systems of ordinary differential equations evolve the parameters of objects that can also undergo stochastic reactions. Thus, the time-ordered product expansion can be used systematically to derive simulation and parameter-fitting algorithms for stochastic systems.

  10. Systems Biology in Animal Production and Health, Vol. 2

    DEFF Research Database (Denmark)

    This two-volume work provides an overview on various state of the art experimental and statistical methods, modeling approaches and software tools that are available to generate, integrate and analyze multi-omics datasets in order to detect biomarkers, genetic markers and potential causal genes...... for improved animal production and health. The book will contain online resources where additional data and programs can be accessed. Some chapters also come with computer programming codes and example datasets to provide readers hands-on (computer) exercises. This second volume deals with integrated modeling...... and analyses of multi-omics datasets from theoretical and computational approaches and presents their applications in animal production and health as well as veterinary medicine to improve diagnosis, prevention and treatment of animal diseases. This book is suitable for both students and teachers in animal...

  11. Systems Biology in Animal Production and Health, Vol. 1

    DEFF Research Database (Denmark)

    This two-volume work provides an overview on various state of the art experimental and statistical methods, modeling approaches and software tools that are available to generate, integrate and analyze multi-omics datasets in order to detect biomarkers, genetic markers and potential causal genes...... for improved animal production and health. The book will contain online resources where additional data and programs can be accessed. Some chapters also come with computer programming codes and example datasets to provide readers hands-on (computer) exercises. This first volume presents the basic principles...... and (bioinformatic) tools available to model and analyse these data sets along with phenotypes in animal production and health. This book is suitable for both students and teachers in animal sciences and veterinary medicine as well as to researchers in this discipline....

  12. Preface for special issue on biological products%生物制品专刊序言

    Institute of Scientific and Technical Information of China (English)

    刘文军

    2011-01-01

    生物制品是一类预防,诊断和治疗疫病的特殊制剂.生物制品的研发是融合微生物学、免疫学、分子生物学、细胞学、基因工程及发酵工艺等学科知识的综合技术体现.生物制品产业是整个生物技术产业的核心和热点.近年来,我国在生物制品研发方面取得了较大进步,为促进我国生物制品研究的交流,本期"生物制品"专刊集中展现了我国生物制品研究人员在预防生物制品、诊断制品、治疗生物制品领域所取得的最新进展.%Biological products are a kind of special agents for the prevention, diagnosis, and treatment of diseases. The research and development of biological products come from the combined knowledge of many subjects, such as microbiology,immunology, molecular biology, cytology, genetic engineering and fermentation technology. Biological products industry is the core and the hot spot of the biotechnology industry. In recent years, China has made some advances in biological products research and development. To promote biological products research in China, invited reviews and selected research articles were published in this special issue of “Biological Products”. The reviews and research articles focus on the field of the biological products for the prevention, diagnosis, and treatment of disease.

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

    Energy Technology Data Exchange (ETDEWEB)

    Suominen, K., E-mail: kimmo.suominen@evira.fi [Finnish Food Safety Authority Evira, Risk Assessment Research Unit, Mustialankatu 3, 00790 Helsinki (Finland); Verta, M. [Finnish Environmental Institute (SYKE), Mechelininkatu 34a, P.O. Box 140, 00251 Helsinki (Finland); Marttinen, S. [MTT Agrifood Research Finland, 31600 Jokioinen (Finland)

    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. - Highlights:

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

    Science.gov (United States)

    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.

  15. Production, Secretion and Biological Activity of Bacillus cereus Enterotoxins

    Directory of Open Access Journals (Sweden)

    Sonia Senesi

    2010-06-01

    Full Text Available Bacillus cereus behaves as an opportunistic pathogen frequently causing gastrointestinal diseases, and it is increasingly recognized to be responsible for severe local or systemic infections. Pathogenicity of B. cereus mainly relies on the secretion of a wide array of toxins and enzymes and also on the ability to undergo swarming differentiation in response to surface-sensing. In this report, the pathogenicity exerted by B. cereus toxins is described with particular attention to the regulatory mechanisms of production and secretion of HBL, Nhe and CytK enterotoxins.

  16. The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals

    DEFF Research Database (Denmark)

    Vermeer, Niels S; Ebbers, Hans C; Straus, Sabine M J M;

    2016-01-01

    BACKGROUND AND OBJECTIVE: The availability of accurate product-specific exposure information is essential in the pharmacovigilance of biologicals, because differences in the safety profile may emerge between products containing the same active substance. In spontaneous adverse drug reaction (ADR......) reports, drug exposure may, however, be misclassified, that is, attributed to the incorrect product. The aim of this study was to explore the effect of exposure misclassification on the time to detection of product-specific risks in spontaneous reporting systems. METHODS: We used data simulations...... reports may result in a delayed detection of product-specific risks, particularly in the detection of weak drug-event associations. Our findings can help inform the future implementation and refinement of product-specific and batch-specific signal detection procedures....

  17. Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation.

    Science.gov (United States)

    Shinde, Vaibhav; Klima, Stefanie; Sureshkumar, Perumal Srinivasan; Meganathan, Kesavan; Jagtap, Smita; Rempel, Eugen; Rahnenführer, Jörg; Hengstler, Jan Georg; Waldmann, Tanja; Hescheler, Jürgen; Leist, Marcel; Sachinidis, Agapios

    2015-06-17

    Efficient protocols to differentiate human pluripotent stem cells to various tissues in combination with -omics technologies opened up new horizons for in vitro toxicity testing of potential drugs. To provide a solid scientific basis for such assays, it will be important to gain quantitative information on the time course of development and on the underlying regulatory mechanisms by systems biology approaches. Two assays have therefore been tuned here for these requirements. In the UKK test system, human embryonic stem cells (hESC) (or other pluripotent cells) are left to spontaneously differentiate for 14 days in embryoid bodies, to allow generation of cells of all three germ layers. This system recapitulates key steps of early human embryonic development, and it can predict human-specific early embryonic toxicity/teratogenicity, if cells are exposed to chemicals during differentiation. The UKN1 test system is based on hESC differentiating to a population of neuroectodermal progenitor (NEP) cells for 6 days. This system recapitulates early neural development and predicts early developmental neurotoxicity and epigenetic changes triggered by chemicals. Both systems, in combination with transcriptome microarray studies, are suitable for identifying toxicity biomarkers. Moreover, they may be used in combination to generate input data for systems biology analysis. These test systems have advantages over the traditional toxicological studies requiring large amounts of animals. The test systems may contribute to a reduction of the costs for drug development and chemical safety evaluation. Their combination sheds light especially on compounds that may influence neurodevelopment specifically.

  18. Synthetic biology and its safety supervision%合成生物学及其安全监管

    Institute of Scientific and Technical Information of China (English)

    刘晓; 唐鸿铃

    2012-01-01

    合成生物学是一门多学科交叉的研究学科,其产品在食品配料、药品、能源以及环境治理等多个重要领域都具有广阔的应用前景.合成生物学研究目前取得了引人注目的进展,但是其可能具有的安全风险也引起公众和各国政府的关注.本文简介现有研究情况及相关监管政策的研讨.%Synthetic biology is an interdisciplinary research subject, which has significant potential in numerous fields, such as food ingredients, pharmacy, energy and environmental pollution treatment. Remarkable progresses have been achieved on synthetic biology recently. However, the related research may also raise safety risk and cause the concern of public and governments. In this paper, we introduce the existing seminars of supervision policies and related research.

  19. Status of research on biological effects and safety of electromagnetic radiation: telecommunications frequencies

    Energy Technology Data Exchange (ETDEWEB)

    Barnett, S.B.

    1994-06-01

    The possible adverse effects on human health of exposure to radiofrequency (RF) and microwave electromagnetic fields and radiation are of public concern. As the ambient electromagnetic environment continues to intensify (e.g. cellular and portable phones, wireless communications, LANs, PCNs) the effects of exposure from cumulative sources and prolonged exposure to low levels needs to be addressed. This review considers RF and microwave radiation above 100 kHz. It is acknowledged that there are several possible areas of biological interaction which have health implications and about which current knowledge is limited. Advice is based on the assessment of risks to health resulting from these exposures as derived from studies on the effects of RF radiation on animals and volunteers and from epidemiological studies of exposed populations. 360 refs., 9 tabs., 1 fig.

  20. Further research on the biological activities and the safety of raspberry ketone are needed

    Science.gov (United States)

    Raspberry ketone supplements have grabbed consumer attention with the possibility they might help burn fat and aid weight loss. While raspberry ketone occurs naturally, and is found in raspberry fruit, most is synthetically produced for use in commercial products as flavorings, fragrances, or dietar...

  1. Development of biological functional material and product from Nelumbo nucifera

    Energy Technology Data Exchange (ETDEWEB)

    Jeong, Il Yun; Park, Yong Dae; Jin, Chang Hyun; Choi, Dae Seong

    2008-01-15

    The solvent extracts of Nelumbo nucifera G. were investigated for the activities of antioxidant, whitening, anti-wrinkle and antimicrobial effects to apply as a functional ingredient for cosmetic products. The electron donating ability of irradiated NN-L extract was above 85% at the concentration of 50ppm. The superoxide dismutase(SOD)-like activity of irradiated NN-L extract was about 76% at 1,000ppm concentration. The xanthine oxidase inhibitory effect of irradiated NN-L extract was about 15% at 1,000ppm. The tyrosinase inhibitory effect of irradiated NN-L extract was about 18% at 1,000ppm. Anti-wrinkle effect, the elastase inhibition activity of irradiated NN-L extract was about 45% at 1,000ppm concentration. All these findings suggested that Nelumbo nucifera G. has a great potential as a cosmeceutical ingredient.

  2. SOURCE, PRODUCTION AND BIOLOGICAL ACTIVITIES OF PICEATANNOL: A REVIEW

    Directory of Open Access Journals (Sweden)

    A. Kukreja*, A. Mishra and A. Tiwari

    2013-10-01

    Full Text Available Phenolic compounds are group of molecules which contain different families of secondary metabolites. Phenolic compounds, secondary metabolites, are abundantly found in plants and are mostly categorized into two major groups: non-soluble compounds and soluble compounds. Stilbenes which come under the category of soluble compounds of phenolics are small molecules, ranges in their weight from ~200 to 300 g/mol and are found in diverse plants. These compounds are produced in plants via phenylpropanoid pathway. Under unfavourable conditions such as microbial or viral attack, ultraviolet light exposure and disease in plants, stilbenes are synthesized and act as natural agents to protect plants. Piceatannol, a natural stilbene, is found in different plant species and is beneficial for human health. It possesses various pharmacological properties such as antioxidant, antitumor, anti-inflammatory and anti-carcinogenic activities. This review paper focuses on piceatannol, its sources, chemical synthesis mechanism, production and its useful applications in various diseases.

  3. A novel biological hydrogen production system. Impact of organic loading

    Energy Technology Data Exchange (ETDEWEB)

    Hafez, Hisham; Nakhla, George; El Naggar, Hesham [Western Ontario Univ. (Canada)

    2010-07-01

    The patent-pending system comprises a novel biohydrogen reactor with a gravity settler for decoupling of SRT from HRT. Two biohydrogenators were operated for 220 days at 37 C, hydraulic retention time 8 h and solids retention time ranged from 1.4 to 2 days under four different glucose concentrations of 2, 8, 16, 32, 48 and 64 g/L, corresponding to organic loading rates of 6.5-206 kg COD/m{sup 3}-d, and started up using anaerobically-digested sludge from the St. Marys wastewater treatment plant (St.Mary, Ontario, Canada) as the seed. The system steadily produced hydrogen with no methane. A maximum hydrogen yield of 3.1 mol H{sub 2} /mol glucose was achieved in the system for all the organic loading rates with an average of 2.8mol H{sub 2} /mol glucose. Acetate and butyrate were the main effluent liquid products at concentrations ranging from 640-7400 mg/L and 400-4600 mg/l, respectively, with no lactate detection. Microbial community analysis using denaturing gradient gel electrophoresis (DGGE) confirmed the absence of lactate producing bacteria Lactobacillus fermentum and other non-hydrogen producing species, and the predominance of various Clostridium species. Biomass concentrations in the biohydrogenators were steady, during the runs, varying form 1500 mg/L at the OLR of 6.5 kg COD/m{sup 3}-d to 14000 mg/L at the 104 kg COD/m{sup 3}-d, thus emphasizing the potential of this novel system for sustained stable hydrogen production and prevention of biomass washout. (orig.)

  4. Metabolic Engineering for Production of Biorenewable Fuels and Chemicals: Contributions of Synthetic Biology

    Directory of Open Access Journals (Sweden)

    Laura R. Jarboe

    2010-01-01

    Full Text Available Production of fuels and chemicals through microbial fermentation of plant material is a desirable alternative to petrochemical-based production. Fermentative production of biorenewable fuels and chemicals requires the engineering of biocatalysts that can quickly and efficiently convert sugars to target products at a cost that is competitive with existing petrochemical-based processes. It is also important that biocatalysts be robust to extreme fermentation conditions, biomass-derived inhibitors, and their target products. Traditional metabolic engineering has made great advances in this area, but synthetic biology has contributed and will continue to contribute to this field, particularly with next-generation biofuels. This work reviews the use of metabolic engineering and synthetic biology in biocatalyst engineering for biorenewable fuels and chemicals production, such as ethanol, butanol, acetate, lactate, succinate, alanine, and xylitol. We also examine the existing challenges in this area and discuss strategies for improving biocatalyst tolerance to chemical inhibitors.

  5. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Science.gov (United States)

    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...

  6. An adapted F-test for homogeneity of variability in follow-on biological products.

    Science.gov (United States)

    Yang, Jun; Zhang, Nan; Chow, Shein-Chung; Chi, Eric

    2013-02-10

    In recent years, follow-on biological products (biosimilars) have received much attention from both the biotechnology industry and the regulatory agencies, especially after the passage of the 2010 healthcare reform bill. Unlike the traditional small-molecule drug products, the development of biological products is not only more complicated but also sensitive to small changes (both mean and variation) in procedure/environment during the manufacturing process because of some fundamental differences between drug products and biological products. A small change will have an impact on the quality of the product and consequently the treatment effect. Thus, in addition to the assessment of biosimilarity in average, it was suggested that biosimilarity in variability between biological products should be assessed. In this article, we propose an adapted F-test for homogeneity of variances to assess biosimilarity in variability. We study the performance and concordance of the proposed adapted F-test and compare it with probability-based method by extensive Monte Carlo simulations.

  7. Phototrophic pigment production with microalgae: biological constraints and opportunities.

    Science.gov (United States)

    Mulders, Kim J M; Lamers, Packo P; Martens, Dirk E; Wijffels, René H

    2014-04-01

    There is increasing interest in naturally produced colorants, and microalgae represent a bio-technologically interesting source due to their wide range of colored pigments, including chlorophylls (green), carotenoids (red, orange and yellow), and phycobiliproteins (red and blue). However, the concentration of these pigments, under optimal growth conditions, is often too low to make microalgal-based pigment production economically feasible. In some Chlorophyta (green algae), specific process conditions such as oversaturating light intensities or a high salt concentration induce the overproduction of secondary carotenoids (β-carotene in Dunaliella salina (Dunal) Teodoresco and astaxanthin in Haematococcus pluvialis (Flotow)). Overproduction of all other pigments (including lutein, fucoxanthin, and phycocyanin) requires modification in gene expression or enzyme activity, most likely combined with the creation of storage space outside of the photosystems. The success of such modification strategies depends on an adequate understanding of the metabolic pathways and the functional roles of all the pigments involved. In this review, the distribution of commercially interesting pigments across the most common microalgal groups, the roles of these pigments in vivo and their biosynthesis routes are reviewed, and constraints and opportunities for overproduction of both primary and secondary pigments are presented.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

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

    2016-12-01

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

  10. An overview of the safety and biological effects of Bacillus thuringiensis Cry toxins in mammals.

    Science.gov (United States)

    Rubio-Infante, Néstor; Moreno-Fierros, Leticia

    2016-05-01

    Crystal proteins (Cry) produced during the growth and sporulation phases of Bacillus thuringiensis (Bt) bacterium are known as delta endotoxins. These toxins are being used worldwide as bioinsecticides to control pests in agriculture, and some Cry toxins are used against mosquitoes to control vector transmission. This review summarizes the relevant information currently available regarding the biosafety and biological effects that Bt and its insecticidal Cry proteins elicit in mammals. This work was performed because of concerns regarding the possible health impact of Cry toxins on vertebrates, particularly because Bt toxins might be associated with immune-activating or allergic responses. The controversial data published to date are discussed in this review considering earlier toxicological studies of B. thuringiensis, spores, toxins and Bt crops. We discussed the experimental studies performed in humans, mice, rats and sheep as well as in diverse mammalian cell lines. Although the term 'toxic' is not appropriate for defining the effects these toxins have on mammals, they cannot be considered innocuous, as they have some physiological effects that may become pathological; thus, trials that are more comprehensive are necessary to determine their effects on mammals because knowledge in this field remains limited.

  11. Improving the efficacy and safety of biologic drugs with tolerogenic nanoparticles

    Science.gov (United States)

    Kishimoto, Takashi K.; Ferrari, Joseph D.; Lamothe, Robert A.; Kolte, Pallavi N.; Griset, Aaron P.; O'Neil, Conlin; Chan, Victor; Browning, Erica; Chalishazar, Aditi; Kuhlman, William; Fu, Fen-Ni; Viseux, Nelly; Altreuter, David H.; Johnston, Lloyd; Maldonado, Roberto

    2016-10-01

    The development of antidrug antibodies (ADAs) is a common cause for the failure of biotherapeutic treatments and adverse hypersensitivity reactions. Here we demonstrate that poly(lactic-co-glycolic acid) (PLGA) nanoparticles carrying rapamycin, but not free rapamycin, are capable of inducing durable immunological tolerance to co-administered proteins that is characterized by the induction of tolerogenic dendritic cells, an increase in regulatory T cells, a reduction in B cell activation and germinal centre formation, and the inhibition of antigen-specific hypersensitivity reactions. Intravenous co-administration of tolerogenic nanoparticles with pegylated uricase inhibited the formation of ADAs in mice and non-human primates and normalized serum uric acid levels in uricase-deficient mice. Similarly, the subcutaneous co-administration of nanoparticles with adalimumab resulted in the durable inhibition of ADAs, leading to normalized pharmacokinetics of the anti-TNFα antibody and protection against arthritis in TNFα transgenic mice. Adjunct therapy with tolerogenic nanoparticles represents a novel and broadly applicable approach to prevent the formation of ADAs against biologic therapies.

  12. Biological effects and physical safety aspects of NMR imaging and in vivo spectroscopy

    Energy Technology Data Exchange (ETDEWEB)

    Tenforde, T.S.; Budinger, T.F.

    1985-08-01

    An assessment is made of the biological effects and physical hazards of static and time-varying fields associated with the NMR devices that are being used for clinical imaging and in vivo spectroscopy. A summary is given of the current state of knowledge concerning the mechanisms of interaction and the bioeffects of these fields. Additional topics that are discussed include: (1) physical effects on pacemakers and metallic implants such as aneurysm clips, (2) human health studies related to the effects of exposure to nonionizing electromagnetic radiation, and (3) extant guidelines for limiting exposure of patients and medical personnel to the fields produced by NMR devices. On the basis of information available at the present time, it is concluded that the fields associated with the current generation of NMR devices do not pose a significant health risk in themselves. However, rigorous guidelines must be followed to avoid the physical interaction of these fields with metallic implants and medical electronic devices. 476 refs., 5 figs., 2 tabs.

  13. Safety considerations for continuous hydrogen production test apparatus with capacity of 50 N-litter hydrogen per hour

    Energy Technology Data Exchange (ETDEWEB)

    Onuki, Kaoru; Akino, Norio; Shimizu, Saburo; Nakajima, Hayato; Higashi, Shunichi; Kubo, Shinji [Japan Atomic Energy Research Inst., Oarai, Ibaraki (Japan). Oarai Research Establishment

    2001-03-01

    Since the thermochemical hydrogen production Iodine-Sulfur process decomposes water into hydrogen and oxygen using toxic chemicals such as sulfuric acid, iodine and hydriodic acid, safety considerations are very important in its research and development. Therefore, before construction of continuous hydrogen production test apparatus with capacity of 50 N-litter hydrogen per hour, comprehensive safety considerations were carried out to examine the design and construction works of the test apparatus, and the experimental plans using the apparatus. Emphasis was given on the safety considerations on prevention of breakage of glasswares and presumable abnormalities, accidents and their countermeasures. This report summarizes the results of the considerations. (author)

  14. Occurrence, pathways and implications of biological production of reactive oxygen species in natural waters

    Science.gov (United States)

    Zhang, T.; Hansel, C. M.; Voelker, B. M.; Lamborg, C. H.

    2014-12-01

    Reactive oxygen species (ROS), such as superoxide (O2-) and hydrogen peroxide (H2O2) play a critical role in the redox cycling of both toxic (e.g., Hg) and nutrient (e.g., Fe) metals. Despite the discovery of extracellular ROS production in various microbial cultures, including fungi, algae and bacteria, photo-dependent processes are generally considered as the predominant source of ROS in natural waters. Here we show that biological production of ROS is ubiquitous and occurs at a significant rate in freshwater and brackish water environments. Water samples were collected from three freshwater and one brackish water ponds in Cape Cod, Massachusetts, USA, periodically from 2012 to 2014. Production of O2- and H2O2 were measured in dark incubations of natural water using a chemiluminescent and a colorimetric probe, respectively. Rates of biological ROS production were obtained by comparing unfiltered with 0.2-μm filtered samples. The role of biological activity in ROS production was confirmed by the cessation of ROS production upon addition of formaldehyde. In surface water, production rates of O2- ranged from undetectable to 96.0 ± 30.0 nmol L-1 h-1, and production rates of H2O2 varied between 9.9 ± 1.3 nmol L-1 h-1 and 145.6 ± 11.2 nmol L-1 h-1. The maximum production rates of both ROS were observed in mid-summer 2013, which coincides with peak biological activity. ROS production in the water from aphotic zone was greater than in the water from photic zone. Thus, non-light dependent biological processes are likely the major contributors to ROS production in this system. Moreover, O2- production appeared to be enhanced by NADH and inhibited by proteinase-K, suggesting the possible involvement of NADH oxidoreductases in this process. The potential role of different microbial communities in ROS production, and the implications of biological ROS production for mercury speciation will also be discussed.

  15. A turning point for natural product discovery - ESF-EMBO research conference : synthetic biology of antibiotic production

    NARCIS (Netherlands)

    Takano, Eriko; Bovenberg, Roel A. L.; Breitling, Rainer

    2012-01-01

    Synthetic Biology is in a critical phase of its development: it has finally reached the point where it can move from proof-of-principle studies to real-world applications. Secondary metabolite biosynthesis, especially the discovery and production of antibiotics, is a particularly relevant target are

  16. Assessment of biochar safety via its leachate characterization using physicochemical and biological assays

    Science.gov (United States)

    Dailianis, Stefanos; Tsouloufa, Argyro; Antonopoulou, Maria; Konstantinou, Ioannis; Karapanagioti, Hrissi K.; Manariotis, Ioannis D.

    2016-04-01

    The present study investigates the physicochemical composition of water aliquots derived from biochars produced from the pyrolysis of malt spent rootlets, in combination with the concomitant toxicological profile in each case. Specifically, physicochemical parameters and heavy metal ions were determined in aliquots of six (6) serial washes of biochar (1.5 g of solid was added in column and washed 6 times with 40 mL of distilled water per wash). The chemical analysis of each aliquot showed increased levels of PO4-3, Cl-, NO3-, SO4-2, F- and Br- in the first wash aliquot, followed by a significant decrease over washes. Non-detectable concentrations were observed after 3 washes in almost all cases. Similarly, the increased levels of Zn, Be, Cs, Mn, V and Se determined in the first wash aliquot were eliminated followed successive washes. In parallel, the toxic potency of each wash aliquot was recorded by (a) a multi-well test plate bioassay, using instars II-III larvae of the fairy shrimp Thamnocephalus platyurus, hatched from cysts derived from Screening Toxicity test supplied by MicroBio Tests Inc. (Thamnotoxkit FTM) and (b) the Microtox bioassay, using bioluminescent bacteria Vibrio fischeri. According to the results, first and second wash aliquots were toxic for T. platyurus (LC50 values of 22.12 and 68.28% v/v, respectively), followed by a significant elimination of toxicity after further washes in all cases. Similarly, the Microtox bioassay showed a significant inhibition of Vibrio luminescence after treatment for a period of 5-90 min (98-100% inhibition of luminescence) with the first wash aliquot (EC50 ≤ 0.01 % v/v), with no toxicity to be observed after successive washes. According to the results, at least one wash of biochar is prerequisite for improving its safety for further use. Moreover, the removal of both inorganic and organic, such as metal ions, substances commonly washed by the biochar, could be a crucial step for its sustainable use and final

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  19. Recent progress in synthetic biology for microbial production of C3-C10 alcohols

    Directory of Open Access Journals (Sweden)

    Edna N. Lamsen

    2012-06-01

    Full Text Available The growing need to address current energy and environmental problems has sparked an interest in developing improved biological methods to produce liquid fuels from renewable sources. While microbial ethanol production is well established, higher chain alcohols possess chemical properties that are more similar to gasoline. Unfortunately, these alcohols (except 1-butanol are not produced efficiently in natural microorganisms, and thus economical production in industrial volumes remains a challenge. Synthetic biology, however, offers additional tools to engineer synthetic pathways in user-friendly hosts to help increase titers and productivity of these advanced biofuels. This review concentrates on recent developments in synthetic biology to produce higher-chain alcohols as viable renewable replacements for traditional fuel.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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

  2. Safety and immunogenicity of Onderstepoort Biological Products’ Rift Valley fever Clone 13 vaccine in sheep and goats under field conditions in Senegal

    Directory of Open Access Journals (Sweden)

    Modou M. Lo

    2015-02-01

    Full Text Available This blinded field safety study was conducted in Senegal to assess safety and immunogenicity of administration of the registered dose of Rift Valley fever virus (RVFV Clone 13 vaccine (Onderstepoort Biological Products to sheep and goats of West African breeds under natural conditions. A total of 267 small ruminants (220 sheep, 47 goats were included; half received RVFV Clone 13 vaccine at the recommended dose and half received the diluent (as placebo only. The study was performed on three commercial farms in the northern and eastern region of Senegal in accordance with veterinary good clinical practices. The animals were observed daily for 3 days after vaccination, and then weekly for 1 year. In both sheep and goats vaccinated against RVFV seroconversion rates above 70% were recorded. No seroconversion related to RVFV was observed in placebo-treated animals. No statistically significant differences were determined between placebo and vaccinated groups for mean rectal temperatures for the first 3 days after administration (p > 0.05. No abnormal clinical signs related to treatment were noted, and only one slight injection site reaction was observed in one vaccinated animal for 2 days after vaccination. Out of 176 births assessed over 1 year (93 from the vaccinated group, 83 from the placebo group, 9 were abnormal in the placebo group and 3 in the vaccinated group (p > 0.05. The frequency of adverse events was similar in the placebo and vaccinated groups. RVFV Clone 13 vaccine administered according to the manufacturer’s instructions was safe and well tolerated in West African breeds of sheep and goats, including animals of approximately 6 months of age and pregnant females, under field conditions in Senegal. Antibody levels persisted up to 1 year after vaccination.

  3. Bioinformatics for the synthetic biology of natural products: integrating across the Design–Build–Test cycle

    Science.gov (United States)

    Currin, Andrew; Jervis, Adrian J.; Rattray, Nicholas J. W.; Swainston, Neil; Yan, Cunyu; Breitling, Rainer

    2016-01-01

    Covering: 2000 to 2016 Progress in synthetic biology is enabled by powerful bioinformatics tools allowing the integration of the design, build and test stages of the biological engineering cycle. In this review we illustrate how this integration can be achieved, with a particular focus on natural products discovery and production. Bioinformatics tools for the DESIGN and BUILD stages include tools for the selection, synthesis, assembly and optimization of parts (enzymes and regulatory elements), devices (pathways) and systems (chassis). TEST tools include those for screening, identification and quantification of metabolites for rapid prototyping. The main advantages and limitations of these tools as well as their interoperability capabilities are highlighted. PMID:27185383

  4. Influence of organic fertilizer Biopro- ferm on ecological, biological and agrochemical properties of soil and winter wheat productivity

    OpenAIRE

    V. Gnydjuk

    2012-01-01

    Results of research on the effect of organic fertilizer Bioproferm obtained by biological fermentation of organic wastes of livestock and poultry facilities, environmental, biological and agrochemical soil properties and productivity of winter wheat

  5. Gold nanoparticles prepared by laser ablation in aqueous biocompatible solutions: assessment of safety and biological identity for nanomedicine applications

    Directory of Open Access Journals (Sweden)

    Correard F

    2014-11-01

    Full Text Available Florian Correard,1,2 Ksenia Maximova,3 Marie-Anne Estève,1,2 Claude Villard,1 Myriam Roy,4 Ahmed Al-Kattan,3 Marc Sentis,3 Marc Gingras,4 Andrei V Kabashin,3 Diane Braguer1,2 1Aix Marseille Université, INSERM, CR02 UMR_S911, Marseille, France; 2APHM, Hôpital Timone, Marseille, France; 3Aix Marseille Université, CNRS, LP3 UMR 7341, Marseille, France; 4Aix Marseille Université, CNRS, CINAM, UMR 7325 Marseille, France Abstract: Due to excellent biocompatibility, chemical stability, and promising optical properties, gold nanoparticles (Au-NPs are the focus of research and applications in nanomedicine. Au-NPs prepared by laser ablation in aqueous biocompatible solutions present an essentially novel object that is unique in avoiding any residual toxic contaminant. This paper is conceived as the next step in development of laser-ablated Au-NPs for future in vivo applications. The aim of the study was to assess the safety, uptake, and biological behavior of laser-synthesized Au-NPs prepared in water or polymer solutions in human cell lines. Our results showed that laser ablation allows the obtaining of stable and monodisperse Au-NPs in water, polyethylene glycol, and dextran solutions. The three types of Au-NPs were internalized in human cell lines, as shown by transmission electron microscopy. Biocompatibility and safety of Au-NPs were demonstrated by analyzing cell survival and cell morphology. Furthermore, incubation of the three Au-NPs in serum-containing culture medium modified their physicochemical characteristics, such as the size and the charge. The composition of the protein corona adsorbed on Au-NPs was investigated by mass spectrometry. Regarding composition of complement C3 proteins and apolipoproteins, Au-NPs prepared in dextran solution appeared as a promising drug carrier. Altogether, our results revealed the safety of laser-ablated Au-NPs in human cell lines and support their use for theranostic applications. Keywords: protein

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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.

  9. Biologic

    CERN Document Server

    Kauffman, L H

    2002-01-01

    In this paper we explore the boundary between biology and the study of formal systems (logic). In the end, we arrive at a summary formalism, a chapter in "boundary mathematics" where there are not only containers but also extainers ><, entities open to interaction and distinguishing the space that they are not. The boundary algebra of containers and extainers is to biologic what boolean algebra is to classical logic. We show how this formalism encompasses significant parts of the logic of DNA replication, the Dirac formalism for quantum mechanics, formalisms for protein folding and the basic structure of the Temperley Lieb algebra at the foundations of topological invariants of knots and links.

  10. The Use of Alternative Raw Material in Production of Pastry Products as a Progressive Direction in Creating the Products of High Biological Value

    Directory of Open Access Journals (Sweden)

    Janа Bachinska

    2017-02-01

    Full Text Available This paper examines the impact of the use of alternative vegetable raw materials in the manufacture of pastry products with high biological value; it presents the results of evaluation of commodity of the developed products and compares them with the main samples presented in Kharkiv trade network. The feasibility of using a mixture of fiber and pumpkin seeds in the technology of pastry production to extend the range of confectionery products of high biological value and products with reduced calories has been proved. Adding the mixture of fiber and pumpkin seeds to biscuits and cakes positively affected the chemical composition of the ready-made product, saturating it with useful and necessary to human body mineral elements, vitamins, dietary fiber.

  11. 21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.

    Science.gov (United States)

    2010-04-01

    ... human prescription drug and biological products. 201.56 Section 201.56 Food and Drugs FOOD AND DRUG... human prescription drug and biological products. (a) General requirements. Prescription drug labeling... requirements in §§ 201.56(d) and 201.57. (1) The following categories of prescription drug products are...

  12. Safety Evaluation Method of power production%电力生产安全性评价方法研究

    Institute of Scientific and Technical Information of China (English)

    陈萍

    2015-01-01

    近年来,随着我国工农业用电量的持续增加,电力企业面临着非常严峻的问题,即如何确保电力生产的安全性.针对电力生产安全问题,本文主要在介绍安全性评价概念的基础上,对电力生产与运行中的安全性评价作了详细研究,并提出了电力生产安全评价的具体方法,从而确保电力系统的安全运行.%In recent years, with the continued increase in industrial and agricultural use of electricity, power companies facing a very serious problem, namely, how to ensure the safety of power production. For power production safety issue, this paper describes the safety evaluation on the basis of the concept, the production of electricity and the operation of the safety evaluation of detailed study and propose concrete methods of power production safety evaluation to ensure the safety of the power system run.

  13. Biological Constraints in Tomato Production in the Western Highlands of Cameroon

    Directory of Open Access Journals (Sweden)

    Fontem, DA.

    1999-01-01

    Full Text Available Tomato (Lycopersicon esculentum production is handicapped by damage due to pests and pathogens. Farmers' fields in the western highlands of Cameroon were surveyed during 1993 to 1996 to identify biological constraints in production. Diseases and insect pests are the most important biological limitations in tomato production. Late blight caused by Phytophthora infestans and early blight caused by Alternaria solani are the most severe diseases, while the melon fruitfly (Dacus cucurbitae is the most prevalent insect pest. Yield losses due to pest damage are high and reach 100 % when the crop is not treated in the wet season. Pest-resistant varieties are not available to farmers. Consequently, growers practise intensive pesticidal spray programmes to limit losses caused by pests and diseases. Results indicate the necessity for the adoption of integrated pest management strategies in tomato production in Cameroon.

  14. A consilience model to describe N2O production during biological N removal

    DEFF Research Database (Denmark)

    Domingo Felez, Carlos; Smets, Barth F.

    2016-01-01

    Nitrous oxide (N2O), a potent greenhouse gas, is produced during biological nitrogen conversion in wastewater treatment operations. Complex mechanisms underlie N2O production by autotrophic and heterotrophic organisms, which continue to be unravelled. Mathematical models that describe nitric oxide...... (NO) and N2O dynamics have been proposed. Here, a first comprehensive model that considers all relevant NO and N2O production and consumption mechanisms is proposed. The model describes autotrophic NO production by ammonia oxidizing bacteria associated with ammonia oxidation and with nitrite reduction......, followed by NO reduction to N2O. It also considers NO and N2O as intermediates in heterotrophic denitrification in a 4-step model. Three biological NO and N2O production pathways are accounted for, improving the capabilities of existing models while not increasing their complexity. Abiotic contributions...

  15. New approaches to estimation of peat deposits for production of biologically active compounds

    Science.gov (United States)

    Stepchenko, L. M.; Yurchenko, V. I.; Krasnik, V. G.; Syedykh, N. J.

    2009-04-01

    It is known, that biologically active preparations from peat increase animals productivity as well as resistance against stress-factors and have adaptogeneous, antioxidant, immunomodulative properties. Optymal choice of peat deposits for the production of biologically active preparations supposes the detailed comparative analysis of peat properties from different deposits. For this the cadastre of peat of Ukraine is developed in the humic substances laboratory named after prof. Khristeva L.A. (Dnipropetrovsk Agrarian University, Ukraine). It based on the research of its physical and chemical properties, toxicity and biological activity, and called Biocadastre. The Biocadastre is based on the set of parameters, including the descriptions of physical and chemical properties (active acidity, degree of decomposition, botanical composition etc.), toxicity estimation (by parabyotyc, infusorial, inhibitor and other tests), biological activity indexes (growth-promoting, antioxidative, adaptogeneous, immunomodulative antistress and other actions). The blocks of Biocadastre indexes are differentiated, taking into account their use for creation the preparations for vegetable, animals and microorganisms. The Biocadastre will allow to choose the peat deposits, most suitable for the production of different biologically active preparations, both wide directed and narrow spectrum of action, depending on application fields (medicine, agriculture, veterinary medicine, microbiological industry, balneology, cosmetology).

  16. Gentiana scabra Bunge. Formula for Herpes Zoster: Biological Actions of Key Herbs and Systematic Review of Efficacy and Safety.

    Science.gov (United States)

    Wang, Kaiyi; Coyle, Meaghan E; Mansu, Suzi; Zhang, Anthony Lin; Xue, Charlie Changli

    2017-01-12

    This study reviewed the biological action of key herbs and evaluated systematically the efficacy and safety of oral Gentiana formula for herpes zoster (HZ). Experimental studies relevant to HZ were identified in PubMed. Randomized controlled trials using Gentiana formula for HZ were identified from nine English and Chinese databases. The primary outcome was evaluation of pain. Potential risk of bias was assessed. Meta-analysis was conducted using mean difference or risk ratio with 95% confidence intervals. Key herbs Gentiana scabra Bunge, Gentiana triflora Pall, Scutellaria baicalensis Georgi, and Gardenia jasminoides Ellis have shown antiinflammatory actions through inhibition of inflammatory cytokines and pro-inflammatory enzymes. Twenty-six clinical studies, involving 2955 participants, were included. Modified Gentiana formula resolved pain earlier than pharmacotherapy when used alone or combined with topical Chinese herbal medicine. Incidence of postherpetic neuralgia was lower (risk ratio 0.14, 95% confidence interval 0.03 to 0.74) with modified Gentiana formula plus topical Chinese herbal medicine. Mild adverse events were reported. Antiinflammatory actions of key herbs of Gentiana formula may explain clinical benefit in hastening pain relief and decreasing postherpetic neuralgia. Few adverse events were reported. Findings were limited by study quality and diversity in intervention and comparator dosage. Copyright © 2017 John Wiley & Sons, Ltd.

  17. European legal developments in product safety and liability: the role of customer complaint management as a defensive marketing tool

    NARCIS (Netherlands)

    Ruyter, de Ko; Brack, Antoni

    1993-01-01

    In view of recent European legal developments, our purpose in this article is to position customer complaint management as an essential instrument for a defensive marketing strategy, specifically to prevent legal problems in the fields of product liability and product safety.

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

    Science.gov (United States)

    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

  19. Performance Testing and Quality Control of Biological Safety Cabinets%生物安全柜的性能检测与质量控制

    Institute of Scientific and Technical Information of China (English)

    赵伟

    2013-01-01

    Objective Through performance testing of biological safety cabinet,to understand its performance,so as to improve its safety.Methods Six required items are tested according to the standard of Biological Safety Cabinets.Results The six required items can meet the technical requirements,the biological safety cabinet is qualified.Conclusion Quality control of medical equipment is of great significance.%目的 通过对生物安全柜的性能检测,以掌握其性能现状,提高使用的安全性.方法 依据《生物安全柜》标准,对生物安全性等6个必检项目进行性能检测.结果 6个检测项目符合技术要求,生物安全柜性能合格.结论 加强医疗设备质量控制关系重大,不容忽视.

  20. Impact of synthetic biology and metabolic engineering on industrial production of fine chemicals

    DEFF Research Database (Denmark)

    Jullesson, David; David, Florian; Pfleger, Brian

    2015-01-01

    Industrial bio-processes for fine chemical production are increasingly relying on cell factories developed through metabolic engineering and synthetic biology. The use of high throughput techniques and automation for the design of cell factories, and especially platform strains, has played...

  1. 76 FR 79203 - Prospective Grant of Exclusive License: Veterinary Biological Products for Swine Influenza Vaccines

    Science.gov (United States)

    2011-12-21

    ... Biological Products for Swine Influenza Vaccines AGENCY: National Institutes of Health, Public Health Service... methods of use as Veterinary Influenza Vaccines. Sustained outbreaks of highly pathogenic influenza in animals increase the risk of reassortment and adaption to humans. This technology describes DNA...

  2. Biological productivity and potential resources of the exclusive economic zone (EEZ) of India

    Digital Repository Service at National Institute of Oceanography (India)

    Goswami, S.C.

    An assessment of the biological production and the potential fishery resources has been made based on the data collected over a period of 15 years (1976-1991). The entire Exclusive Economic Zone (EEZ), measuring 2.02 million km sup(2) was divided...

  3. Process for the continuous biological production of lipids, hydrocarbons or mixtures thereof

    NARCIS (Netherlands)

    Van der Wielen, L.A.M.; Heijnen, J.J.

    2010-01-01

    The present invention is directed to a process for the continuous biological production of lipids, hydrocarbons, hydrocarbon like material or mixtures thereof by conversion of a suitable substrate using micro-organisms, in which process the said substrate is continuously, anaerobically fermented to

  4. Dilute-acid pretreatment of barley straw for biological hydrogen production using Caldicellulosiruptor saccharolyticus

    NARCIS (Netherlands)

    Panagiotopoulos, I.A.; Bakker, R.R.C.; Vrije, de G.J.; Claassen, P.A.M.; Koukios, E.G.

    2012-01-01

    The main objective of this study was to use the fermentability test to investigate the feasibility of applying various dilute acids in the pretreatment of barley straw for biological hydrogen production. At a fixed acid loading of 1% (w/w dry matter) 28-32% of barley straw was converted to soluble m

  5. Microwave-ultrasound combined reactor suitable for atmospheric sample preparation procedure of biological and chemical products

    NARCIS (Netherlands)

    Lagha, A.; Chemat, S.; Bartels, P.V.; Chemat, F.

    1999-01-01

    A compact apparatus in which a specific position can be irradiated by microwaves (MW) and ultrasound (US) simultaneously has been developed. The MW-US reactor has been designed for atmospheric pressure digestion and dissolution of biological and chemical products. The reactor can treat a range of th

  6. 78 FR 32668 - Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood...

    Science.gov (United States)

    2013-05-31

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture'' dated June 2013. The draft guidance document provides manufacturers of licensed Whole Blood and blood components intended for......

  7. Scientific opinion on the safety of smoke flavouring Primary Product SmokEz Enviro 23 - 2012 Update

    Directory of Open Access Journals (Sweden)

    EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF

    2012-07-01

    Full Text Available

    The EFSA CEF Panel updated the safety assessment of the smoke flavouring Primary Product SmokEz Enviro 23. In 2009, the Panel concluded that the margins of safety for this Primary Product were insufficient and the proposed use levels were considered of safety concern. After the opinion of 2009 the Panel received new data i.e. new use levels, chemical data and a new 90-day toxicity study, which resulted in this update of the previous opinion. The new chemical data provided demonstrate that the test material used in the new 90-day toxicity study is representative of the Primary Product evaluated by EFSA. Based on the findings from the 90-day study submitted in 2009 and from the newly submitted one, the Panel derived a NOAEL for Primary Product SmokEz Enviro 23 of 598 mg/kg bw/day based on absolute and relative kidney weight changes in female rats. Based on newly submitted normal use levels, the margins of safety are 62 and 77 (total dietary exposure and 65 and 89 (use in traditionally smoked foods only depending on the exposure scenario used. Given that these margins of safety are based on 90-day toxicity studies, and given the absence of data on reproduction, developmental toxicity and of long term studies, it is concluded that the uses and use levels of Primary Product would require a larger margin of safety. The Panel concluded that the proposed use of the Primary Product at the uses and use levels specified is of safety concern.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    Nash, J Frank; Tanner, Paul R

    2014-01-01

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

  10. 有关生物实验室安全问题的思考%Thinking about the Safety of Biological Laboratories

    Institute of Scientific and Technical Information of China (English)

    赵伟辰

    2015-01-01

    The 21st century, scientific research projects in universities and the creation of course more and more diverse, the study and application of biological technology becomes more common, the corresponding biological laboratory use and safety is particularly important. Laboratory safety problems and corresponding safety measures were profound thinking, illustrates the biological laboratory hardware and software security risks from ideology, full participation, security system from three aspects: describes the biological laboratory of the central task and countermeasures.%21世纪后,高校科研项目和开设课程越来越多样化,生物技术的学习和应用也随之更为普遍,相应的生物实验室的使用和安全就尤为重要。就实验室安全方面出现的问题及相应的安全对策进行了深刻的思考,说明了生物实验室硬件和软件两方面存在的安全隐患,从思想意识、全员参与、安全制度三个方面阐述了生物实验室的中心任务和对策。

  11. Statistical and regulatory considerations in assessments of interchangeability of biological drug products.

    Science.gov (United States)

    Tóthfalusi, Lászlo; Endrényi, László; Chow, Shein-Chung

    2014-05-01

    When the patent of a brand-name, marketed drug expires, new, generic products are usually offered. Small-molecule generic and originator drug products are expected to be chemically identical. Their pharmaceutical similarity can be typically assessed by simple regulatory criteria such as the expectation that the 90% confidence interval for the ratio of geometric means of some pharmacokinetic parameters be between 0.80 and 1.25. When such criteria are satisfied, the drug products are generally considered to exhibit therapeutic equivalence. They are then usually interchanged freely within individual patients. Biological drugs are complex proteins, for instance, because of their large size, intricate structure, sensitivity to environmental conditions, difficult manufacturing procedures, and the possibility of immunogenicity. Generic and brand-name biologic products can be expected to show only similarity but not identity in their various features and clinical effects. Consequently, the determination of biosimilarity is also a complicated process which involves assessment of the totality of the evidence for the close similarity of the two products. Moreover, even when biosimilarity has been established, it may not be assumed that the two biosimilar products can be automatically substituted by pharmacists. This generally requires additional, careful considerations. Without declaring interchangeability, a new product could be prescribed, i.e. it is prescribable. However, two products can be automatically substituted only if they are interchangeable. Interchangeability is a statistical term and it means that products can be used in any order in the same patient without considering the treatment history. The concepts of interchangeability and prescribability have been widely discussed in the past but only in relation to small molecule generics. In this paper we apply these concepts to biosimilars and we discuss: definitions of prescribability and interchangeability and

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

    Science.gov (United States)

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

    Science.gov (United States)

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

    1998-01-01

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

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

    Science.gov (United States)

    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.

  15. Antibiotic susceptibility and antimicrobial activity of autochthonous starter cultures as safety parameters for fresh cheese production

    Directory of Open Access Journals (Sweden)

    Dora Bučan

    2013-11-01

    Full Text Available The antibiotic susceptibility and antimicrobial activity, as food safety parameters important for application of autochthonous lactic acid bacteria (LAB, that previously satisfied technological criteria for functional starter cultures in fresh cheese production were examined. Soluble whole cell protein patterns of autochthonous LAB strains from fresh cheese, obtained by SDS-PAGE, revealed the presence of two predominant strains, which were identified as Lactobacillus fermentum A8 and Enterococcus faecium A7. These strains were not resistant and shown susceptibility to antibiotics: ampicillin, bacitracin, penicillin G, azithromycin, chloramphenicol, clarithromycin, clindamycin, spiramycin, tetracycline, streptomycin, neomycin, gentamicin, erythromycin, rifampicin and novobiocin. Lb. fermentum A8 strain displayed phenotypic resistance to vancomycin, but this resistance is intrinsic, not transferable and it is acceptable from the safety aspect. The capacity of Lb. fermentum A8 and Ec. faecium A7 to inhibit growth of test-microorganisms Listeria monocytogenes ATCC 11911, Escherichia coli 3014, Salmonella enterica serovar Typhimurium FP1 and Staphylococcus aureus 3048, was also analysed. According to obtained results, Lb. fermentum A8 and Ec. faecium A7 are safe from the aspect of spreading antibiotic resistance and could be useful as bioprotective cultures that inhibit common bacterial food contaminants, including L. monocytogenes.

  16. Investigation of specificity ensuring of quality of biological medicinal products on example of drugs Cortexin and Retinalamin

    Directory of Open Access Journals (Sweden)

    N. O. Vetiutneva

    2013-06-01

    Full Text Available Biological medical products nowadays are one of the most promising area at the pharmaceutical market. Biopharmaceutical market has significant benefits such as fast and effective development of production facilities, the development of more effective and safer medical products. The aim of our research was, on the example of medical products Cortexin and Retinalamin, examine the specifics of quality of biological medicinal products in the chain from production to sale. The objects of study - original biological medicines Cortexin and Retinalamin. Comparative, systematic, analytical methods and reviews were used. Biological medical products have fundamental differences from synthetic medicines, due to their source - alive cells which are usually used in their production process. Each production cycle results in a unique finished pharmaceutical products and minimal differences in the modes of production can significantly effect on the properties of biological medical products. Therefore, even if the physical, chemical and biological properties of the product thoroughly studied and described, it does not guarantee therapeutic equivalence of two biological products which are manufactured in different conditions. One of the most important issues today is the problem of maintaining properties and quality of biological medicines. These issues are actively resolving on the native pharmaceutical market: quality control system are developing and implementing in accordance with international standards in order to maintain maximum efficiency of biological medicines and to protect consumers from defective products. Biological products require special conditions of storage and transportation. In order to save physical, chemical and therapeutic properties, strict compliance with the relevant conditions of packaging, transport and intermediate storage, related to deviations in temperature during transportation and storage is needed. The production process

  17. Composition of thermodestruction products of biologically active compounds polluting the atmosphere

    Energy Technology Data Exchange (ETDEWEB)

    Dmitriyev, M.T.; Rastyannikov, Y.G.; Sotnikov, Y.Y.; Volkov, S.A.

    1981-01-01

    The most promising method of removal of biologically active compounds such as microorganisms, antibiotics, food and other household waste from industrial waste gases is to destroy them by thermal destruction including burning. In this case, products of thermodestruction enter into the atmosphere along with carbon dioxide and steam and can unfavorably affect the population. Thus, mass spectrometric analyses have determined in the waste gases of antibiotics production aldehydes and ketones (croton- and adipalaldehydes, acetone), alcohols (propanol and butanol), amines, unsaturated and aromatic hydrocarbons. The composition of thermodestruction products of biologically active compounds was identified by their pyrolysis at 700/sup 0/C for 2 min. in the presence of air. The main components were proteins and amino acids. The products of pyrolysis were analyzed by chromato-mass-spectrometric and gas-chromatographic methods by means of a two-flame thermionic detector. No significant difference between the thermodestruction products of proteins and amino acids was found. Many of detected substances can be not only toxic but also emit strong unpleasant odors. The studies revealed toxic substances that pollute the atmospheric air during removal of biologically-active compounds from waste gases.

  18. Immobilized Biofilm in Thermophilic Biohydrogen Production using Synthetic versus Biological Materials

    Directory of Open Access Journals (Sweden)

    Jaruwan Wongthanate

    2015-02-01

    Full Text Available Biohydrogen production was studied from the vermicelli processing wastewater using synthetic and biological materials as immobilizing substrate employing a mixed culture in a batch reactor operated at the initial pH 6.0 and thermophilic condition (55 ± 1ºC. Maximum cumulative hydrogen production (1,210 mL H2/L wastewater was observed at 5% (v/v addition of ring-shaped synthetic material, which was the ring-shaped hydrophobic acrylic. Regarding 5% (v/v addition of synthetic and biological materials, the maximum cumulative hydrogen production using immobilizing synthetic material of ball-shaped hydrophobic polyethylene (HBPE (1,256.5 mL H2/L wastewater was a two-fold increase of cumulative hydrogen production when compared to its production using immobilizing biological material of rope-shaped hydrophilic ramie (609.8 mL H2/L wastewater. SEM observation of immobilized biofilm on a ball-shaped HBPE or a rope-shaped hydrophilic ramie was the rod shape and gathered into group.

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

    Directory of Open Access Journals (Sweden)

    Simone de Souza Nascimento

    2013-01-01

    Full Text Available 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.

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

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

    Science.gov (United States)

    Saoutert, Erwan; Andreasen, Ina

    2006-04-01

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

  2. Consumer perception: Quality, safety and security of food products based on the Consumer Protection Law

    Directory of Open Access Journals (Sweden)

    Rodolfo Misael Mejía Dietrich

    2016-06-01

    Full Text Available In the last few years the culture of respect toward Salvadoran consumer´s rights has been promoted by government and non-government institutions. The objective of this research was to investigate about the experiences, concerns, and expectations of consumers of the city of San Miguel in relation to the perception about the fulfillment and non-fulfillment of their rights, associated with food quality, safety, and security. This was also contrasted with the opinion emitted by businesspeople with the purpose of establishing similarities and differences related to this topic. Besides, the research was descriptive and explanatory which detailed and analyzed the causes and effects of the relation between the variables to comply with the requirements of: quality and security of food products with rights fulfillment. Data analysis was made by using basic statistic techniques: frequency tables and graphs. Finally, it was found that consumers are sensible to high prices of the basic food basket and this influences their purchase decision; that they receive food products of average quality and that these products are not always accessible to their budgets; likewise, there is a high percentage of consumers that know their rights and duties given by the Consumer Protection Law.

  3. What controls biological productivity in coastal upwelling systems? Insights from a comparative modeling study

    Science.gov (United States)

    Lachkar, Z.; Gruber, N.

    2011-06-01

    The magnitude of the biological productivity in Eastern Boundary Upwelling Systems (EBUS) is traditionally viewed as directly reflecting the upwelling intensity. Yet, different EBUS show different sensitivities of productivity to upwelling-favorable winds (Carr and Kearns, 2003). Here, using a comparative modeling study of the California Current System (California CS) and Canary Current System (Canary CS), we show how physical and environmental factors, such as light, temperature and cross-shore circulation modulate the response of biological productivity to upwelling strength. To this end, we made a series of eddy-resolving simulations of the California CS and Canary CS using the Regional Ocean Modeling System (ROMS), coupled to a nitrogen based Nutrient-Phytoplankton-Zooplankton-Detritus (NPZD) ecosystem model. We find the nutrient content of the euphotic zone to be 20 % smaller in the Canary CS relative to the California CS. Yet, the biological productivity is 50 % smaller in the latter. This is due to: (1) a faster nutrient-replete growth in the Canary CS relative to the California CS, related to a more favorable light and temperature conditions in the Canary CS, and (2) the longer nearshore water residence times in the Canary CS which lead to larger buildup of biomass in the upwelling zone, thereby enhancing the productivity. The longer residence times in the Canary CS appear to be associated with the wider continental shelves and the lower eddy activity characterizing this upwelling system. This results in a weaker offshore export of nutrients and organic matter, thereby increasing local nutrient recycling and enhancing the coupling between new and export production in the Northwest African system. Our results suggest that climate change induced perturbations such as upwelling favorable wind intensification might lead to contrasting biological responses in the California CS and the Canary CS, with major implications for the biogeochemical cycles and fisheries

  4. What controls biological productivity in coastal upwelling systems? Insights from a comparative modeling study

    Directory of Open Access Journals (Sweden)

    Z. Lachkar

    2011-06-01

    Full Text Available The magnitude of the biological productivity in Eastern Boundary Upwelling Systems (EBUS is traditionally viewed as directly reflecting the upwelling intensity. Yet, different EBUS show different sensitivities of productivity to upwelling-favorable winds (Carr and Kearns, 2003. Here, using a comparative modeling study of the California Current System (California CS and Canary Current System (Canary CS, we show how physical and environmental factors, such as light, temperature and cross-shore circulation modulate the response of biological productivity to upwelling strength. To this end, we made a series of eddy-resolving simulations of the California CS and Canary CS using the Regional Ocean Modeling System (ROMS, coupled to a nitrogen based Nutrient-Phytoplankton-Zooplankton-Detritus (NPZD ecosystem model. We find the nutrient content of the euphotic zone to be 20 % smaller in the Canary CS relative to the California CS. Yet, the biological productivity is 50 % smaller in the latter. This is due to: (1 a faster nutrient-replete growth in the Canary CS relative to the California CS, related to a more favorable light and temperature conditions in the Canary CS, and (2 the longer nearshore water residence times in the Canary CS which lead to larger buildup of biomass in the upwelling zone, thereby enhancing the productivity. The longer residence times in the Canary CS appear to be associated with the wider continental shelves and the lower eddy activity characterizing this upwelling system. This results in a weaker offshore export of nutrients and organic matter, thereby increasing local nutrient recycling and enhancing the coupling between new and export production in the Northwest African system. Our results suggest that climate change induced perturbations such as upwelling favorable wind intensification might lead to contrasting biological responses in the California CS and the Canary CS, with major implications for the biogeochemical cycles

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

    Science.gov (United States)

    Hallenbeck, William H.

    1981-01-01

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

  6. New synthetic strategies towards psammaplin A, access to natural product analogues for biological evaluation.

    Science.gov (United States)

    Baud, Matthias G J; Leiser, Thomas; Meyer-Almes, Franz-Josef; Fuchter, Matthew J

    2011-02-07

    New synthetic routes towards the natural product psammaplin A were developed with the particular view to preparing diverse analogues for biological assessment. These routes utilize cheap and commercially available starting materials, and allowed access to psammaplin A analogues not accessible via currently reported methods. Preliminary biological studies revealed these compounds to be the most potent non peptidic inhibitors of the enzyme histone deacetylase 1 (HDAC1, class I) discovered so far. Interestingly, psammaplin A and our synthetic analogues show class I selectivity in vitro, an important feature for the design and synthesis of future isoform selective inhibitors.

  7. Establishing a cell biology platform: isolation and preservation of human blood products

    OpenAIRE

    2014-01-01

    Dissertação para obtenção do Grau de Mestre em Genética Molecular e Biomedicina The use of human primary cells provide researchers in different areas with irrefutable more biologically relevant data than using cell lines or animal blood cells. The work was performed in the scope of the Cell Biology Services @ CEDOC, aiming to provide viable and trustful human primary cells and products. We had three main objectives: protocol optimizations for blood cell isolation, culture and cryopre...

  8. Research on Safety Production Management%安全生产管理研究

    Institute of Scientific and Technical Information of China (English)

    白大鹏

    2012-01-01

    As with the booming development of the economy, the production scales expand continuously, and the production processes adopt a lot of new technologies and new materials. We are glad to see that a lot of new technologies are adopted and applied in the production. Because the management can't keep up with the expansion of the scale of the new technology, they do not have adequate understanding of the security features of new materials and new technologies, and they unilaterally pursue economic benefits, thus the production accidents always occur. The fire, the explosion, the plane crash, the chemical and nuclear leakage accidents and so on seriously threat the safety and the health of human beings. The accidents not only cause economic losses, but also leave shadow and trauma to the mind of human a long time. The safety accidents leave a heavy baggage and unstable factors to the personal, the family and the society. There are three measures to control the accidents, namely technology, management and education, while the management is crucial and it is also the most important measure.%随着我国经济的蓬勃发展,生产规模的不断扩大,生产过程中大量使用新工艺、新材料,新技术不断得到推广和运用,由于管理跟不上规模的扩大,对新工艺、新材料、新技术的安全特性认识不足,片面追求经济效益,致使生产安全事故不断发生,火灾、爆炸、空难、化学品及核泄漏事故等严重威胁着人类的安全和健康.事故不仅造成经济上的损失,而且给人类的心灵留下久久的创伤和难以抹去的阴影,也给个人、家庭和社会留下了沉重的包袱和不稳定因素.事故的控制有“技术、管理、教育”三大对策措施,其中管理是关键的也是最重要的措施和手段.

  9. Biologics in the management of ulcerative colitis – comparative safety and efficacy of TNF-α antagonists

    Directory of Open Access Journals (Sweden)

    Fausel R

    2015-01-01

    Full Text Available Rebecca Fausel,1 Anita Afzali1,2 1Division of Gastroenterology, Department of Medicine, University of Washington, Seattle, WA, USA; 2Inflammatory Bowel Disease Program, UW Medicine – Harborview Medical Center, Seattle, WA, USA Abstract: Ulcerative colitis can cause debilitating symptoms and complications such as colonic strictures, colonic dysplasia, colorectal cancer, and toxic megacolon or perforation. Goals of treatment in ulcerative colitis include resolution of gastrointestinal symptoms, healing of colonic mucosa, and prevention of disease complications. Our treatment armamentarium has expanded dramatically over the past 10 years, and we now have multiple biologic agents approved for the treatment of moderate-severe disease, in addition to conventional therapies such as 5-aminosalicylates, thiopurines, and corticosteroids. In this review, we will provide a detailed discussion of the three tumor necrosis factor-alpha (TNF-α inhibitors currently approved for treatment of ulcerative colitis: infliximab, adalimumab, and golimumab. All three agents are effective for inducing and maintaining clinical response and remission in patients with ulcerative colitis, and they have comparable safety profiles. There are no head-to-head trials comparing their efficacy, and the choice of agent is most often based on insurance coverage, route of administration, and patient preference. Combination therapy with an immunomodulator is proven to be more effective than anti-TNF monotherapy, and patients who lose response to an anti-TNF agent should undergo dose intensification in order to regain clinical response. Despite therapeutic optimization, a significant percentage of patients will not achieve clinical remission with anti-TNF agents, and so newer therapies are on the horizon. Keywords: ulcerative colitis, inflammatory bowel disease, infliximab, adalimumab, golimumab

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

    Energy Technology Data Exchange (ETDEWEB)

    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

  11. Application of Evolutionary Encryption 2D Barcode Generation Technology in Agricultural Product Quality and Safety Traceability System

    Institute of Scientific and Technical Information of China (English)

    Xiaojun; ZHONG; Zhijie; LAI; Yan; CHEN; Jianxin; QIAN; Xiaocong; HONG; Caiyi; LI

    2014-01-01

    Two-dimensional(2D) barcode technology is an electronic tagging technology based on combination of computer and optical technology. It is an important way of information collection and input. 2D barcode technology has been widely used in various fields of logistics,production automation,and e-commerce,but it also has brought about a series of safety problems. Based on evolutionary encryption technology,this paper improved algorithm of traditional 2D barcode generation,to improve forgery- proof performance of 2D barcode. This algorithm is applied to agricultural products quality and safety traceability system and the results show that it is effective.

  12. Metabolic engineering of microorganisms for biofuels production: from bugs to synthetic biology to fuels

    Energy Technology Data Exchange (ETDEWEB)

    Kuk Lee, Sung; Chou, Howard; Ham, Timothy S.; Soon Lee, Taek; Keasling, Jay D.

    2009-12-02

    The ability to generate microorganisms that can produce biofuels similar to petroleum-based transportation fuels would allow the use of existing engines and infrastructure and would save an enormous amount of capital required for replacing the current infrastructure to accommodate biofuels that have properties significantly different from petroleum-based fuels. Several groups have demonstrated the feasibility of manipulating microbes to produce molecules similar to petroleum-derived products, albeit at relatively low productivity (e.g. maximum butanol production is around 20 g/L). For cost-effective production of biofuels, the fuel-producing hosts and pathways must be engineered and optimized. Advances in metabolic engineering and synthetic biology will provide new tools for metabolic engineers to better understand how to rewire the cell in order to create the desired phenotypes for the production of economically viable biofuels.

  13. Biological ensilage additives as pretreatment for maize to increase the biogas production

    Energy Technology Data Exchange (ETDEWEB)

    Vervaeren, H.; Hostyn, K.; Willems, B. [Howest, PIH, Environmental Science Department, Graaf K. de Goedelaan, 5, 8500 Kortrijk (Belgium); Ghekiere, G. [POVLT, Ieperseweg 87, 8800 Rumbeke (Belgium)

    2010-09-15

    Several biological ensilage additives were tested on maize substrate for their effect on biogas production and preservation of ODM content. In general, the addition of some biological additives and subsequent storage for 7 weeks could enhance the biogas and biomethane production per ODM when compared to the untreated sample. A common microbial inoculent containing homo-fermentative and hetero-fermentative bacteria (Bonsilage Mais {sup registered}), had no beneficial effect on biogas and biomethane production compared with the non-treated sample (-12.7% and -13.1% per ODM, respectively). More complex additives with hetero- and homo-fermentative activity (Silasil Energy {sup registered}) as well as enzymes (Sil-all 4 x 4 {sup registered}) or bacteria and yeasts (Microferm {sup registered}) did effectively increase the biogas production per ODM (respectively with 11.8, 10.1 and 14.7%). Losses in ODM content were minor in all samples. These results might indicate that more divergent biological additives involving yeasts or enzymes during ensiling are preferred as maize preservation tools for anaerobic digestion instead of a spontaneous ensilage population or to add only homo- and hetero-fermentative strains. The nature of the additive might enhance the hydrolysis step in the anaerobic digestion process by decomposing complex carbohydrate structures. (author)

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

    Science.gov (United States)

    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

  15. Milk proteins-derived bioactive peptides in dairy products: molecular, biological and methodological aspects

    Directory of Open Access Journals (Sweden)

    Bartłomiej Dziuba

    2014-03-01

    Full Text Available Proteins are one of the primary components of the food, both in terms of nutrition and function. They are main source of amino acids, essential for synthesis of proteins, and also source of energy. Additionally, many proteins exhibit specifi c biological activities, which may have effect on functional or pro-health properties of food products. These proteins and their hydrolysis products, peptides, may infl uence the properties of food and human organism. The number of commercially available food products containing bioactive peptides is very low, apart from that milk proteins are their rich source. It could be supposed that number of available products with declared activity will rise in near future because of observed strong uptrend on interest in such products. Molecular and biological properties of milk proteins, as precursors of bioactive peptides was characterised in the work. Therefore, the strategy of research and obtaining of such peptides both in laboratory and industrial scale, as well as the range of their commercial application, was presented. Several examples of research efforts presenting high potential to develop new products containing bioactive peptides from milk proteins and predetermined as nutraceuticals was described.

  16. Milk proteins-derived bioactive peptides in dairy products: molecular, biological and methodological aspects.

    Science.gov (United States)

    Dziuba, Bartłomiej; Dziuba, Marta

    2014-01-01

    Proteins are one of the primary components of the food, both in terms of nutrition and function. They are main source of amino acids, essential for synthesis of proteins, and also source of energy. Additionally, many proteins exhibit specific biological activities, which may have effect on functional or pro-health properties of food products. These proteins and their hydrolysis products, peptides, may influence the properties of food and human organism. The number of commercially available food products containing bioactive peptides is very low, apart from that milk proteins are their rich source. It could be supposed that number of available products with declared activity will rise in near future because of observed strong uptrend on interest in such products. Molecular and biological properties of milk proteins, as precursors of bioactive peptides was characterised in the work. Therefore, the strategy of research and obtaining of such peptides both in laboratory and industrial scale, as well as the range of their commercial application, was presented. Several examples of research efforts presenting high potential to develop new products containing bioactive peptides from milk proteins and predetermined as nutraceuticals was described.

  17. Role Of Biopreservation In Improving Food Safety And Storage

    OpenAIRE

    Swarnadyuti Nath; Chowdhury, S.

    2014-01-01

    Biopreservation refers to the use of antagonistic microorganisms or their metabolic products to inhibit or destroy undesired microorganisms in foods to enhance food safety and extend shelf life. In order to achieve improved food safety and to harmonize consumer demands with the necessary safety standards, traditional means of controlling microbial spoilage and safety hazards in foods are being replaced by combinations of innovative technologies that include biological antimicrobial systems su...

  18. Welfare and Market Impacts of Food Safety Measures in China:Results from Urban Consumers’ Valuation of Product Attributes

    Institute of Scientific and Technical Information of China (English)

    David L.Ortega; H.Holly Wang; Nicole J.Olynk Widmar

    2014-01-01

    This study provides an economics assessment of various food safety measures in China. A choice experiment approach is used to elicit Chinese consumer preferences for various food safety attributes using data from a 2008 urban consumer survey. An alternative welfare calculation is used to model aggregate market impacts of select food safety measures. Our results show that the largest welfare gains are found in the current government-run certiifcation program. The implementation of a third-party certiifcation system, a traceability network and a product label would generate signiifcant value and would help reduce current system inefifciencies in China. This study builds on previous research and provides an alternative approach for calculating consumer valuation of safety and quality attributes that can be used to estimate aggregate economic and welfare impacts.

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

    Science.gov (United States)

    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.

  20. Future 100 TeV colliders' safety in the context of stable micro black holes production

    CERN Document Server

    Sokolov, Anton V

    2016-01-01

    In the theories with extra dimensions the higher-dimensional Planck mass could be as small as 1 TeV, that entails the possibility that a considerable amount of microscopic black holes can be produced during runs of future high energy colliders. According to the laws of quantum theory, these black holes are supposed to evaporate immediately; however, due to the lack of the experimental data confirming this process as well as in absence of a reliable theory of quantum gravity, for the exhaustive analysis of safety one has to consider the worst case in which the micro black holes could be stable. In this paper we consider the theories with the different number of extra dimensions and deduce which of them yield Earth's accretion times smaller than the lifetime of the Solar system. We calculate the cross sections of the black hole production at the 100 TeV collider, the fraction of the black holes trapped inside the Earth and the resulting rate of production. We study the astrophysical consequences of stable micro...

  1. Characterization of persistent colors and decolorization of effluent from biologically treated cellulosic ethanol production wastewater.

    Science.gov (United States)

    Shan, Lili; Liu, Junfeng; Yu, Yanling; Ambuchi, John J; Feng, Yujie

    2016-05-01

    The high chroma of cellulosic ethanol production wastewater poses a serious environmental concern; however, color-causing compounds are still not fully clear. The characteristics of the color compounds and decolorization of biologically treated effluent by electro-catalytic oxidation were investigated in this study. Excitation-emission matrix (EEM), fourier transform infrared spectrometer (FTIR), UV-Vis spectra, and ultrafiltration (UF) fractionation were used to analyze color compounds. High chroma of wastewater largely comes from humic materials, which exhibited great fluorescence proportion (67.1 %) in the biologically treated effluent. Additionally, the color compounds were mainly distributed in the molecular weight fractions with 3-10 and 10-30 kDa, which contributed 53.5 and 34.6 % of the wastewater color, respectively. Further decolorization of biologically treated effluent by electro-catalytic oxidation was investigated, and 98.3 % of color removal accompanied with 97.3 % reduction of humic acid-like matter was achieved after 180 min. The results presented herein will facilitate the development of a well decolorization for cellulosic ethanol production wastewater and better understanding of the biological fermentation.

  2. High-latitude controls of thermocline nutrients and low latitude biological productivity.

    Science.gov (United States)

    Sarmiento, J L; Gruber, N; Brzezinski, M A; Dunne, J P

    2004-01-01

    The ocean's biological pump strips nutrients out of the surface waters and exports them into the thermocline and deep waters. If there were no return path of nutrients from deep waters, the biological pump would eventually deplete the surface waters and thermocline of nutrients; surface biological productivity would plummet. Here we make use of the combined distributions of silicic acid and nitrate to trace the main nutrient return path from deep waters by upwelling in the Southern Ocean and subsequent entrainment into subantarctic mode water. We show that the subantarctic mode water, which spreads throughout the entire Southern Hemisphere and North Atlantic Ocean, is the main source of nutrients for the thermocline. We also find that an additional return path exists in the northwest corner of the Pacific Ocean, where enhanced vertical mixing, perhaps driven by tides, brings abyssal nutrients to the surface and supplies them to the thermocline of the North Pacific. Our analysis has important implications for our understanding of large-scale controls on the nature and magnitude of low-latitude biological productivity and its sensitivity to climate change.

  3. [Microbiological and biological methods of the European Pharmacopoeia. Relevant for each medicinal product].

    Science.gov (United States)

    Norwig, J

    2014-10-01

    According to the EU Directive 2001/83 the European Pharmacopoeia is the official Pharmacopoeia of the European Union. Therefore the European Pharmacopoeia is one of the legal pharmacopoeial compendia in Germany. Any licensed medicinal product on the German market complies with the requirements of the compendial monographs, if applicable. Because the general monographs of the European Pharmacopoeia on Dosage Forms, Substances for Pharmaceutical Use and Pharmaceutical Preparations refer to the microbiological and biological methods of the Pharmacopoeia, the methods are relevant for medicinal products, too. This article presents a rough summary of the microbiological and biological methods of the European Pharmacopoeia and is intended to be a stimulus for the reader to better understand the original compendia. The short description of the methods mentioned, here, is a summary from the Pharmacopoeia and the non-official collection of comments on the texts of the European Pharmacopoeia.

  4. COMPARATIVE EFFICACY AND SAFETY OF HYPOLIPIDEMIC THERAPY WITH GENERIC AND ORIGINAL MEDICINAL PRODUCTS OF SIMVASTATIN

    Directory of Open Access Journals (Sweden)

    E. I. Tarlovskaya

    2011-01-01

    Full Text Available Aim. To compare efficacy , safety and pharmacoeconomical characteristics of generic and original medicinal products of simvastatin in achievement of cholesterol and low density lipoprotein target levels. Material and methods. 38 patients with arterial hypertension accompanied by type 2 diabetes with dyslipidemia were included into the study. They had no clinically obvious ischemic heart disease and did not receive hypolipidemic pharmacotherapy for a month before the study start. The patients were randomized into group A or group B. Patients of group A (n=18 received original simvastatin, patients of group B (n=20 received generic simvastatin. Initial simvastatin dose was 20 mg daily. Lipid plasma profile, liver enzymes, creatine phosphokinase were evaluated every 4 weeks. Cost-effectiveness ratio was calculated. Results. 11 patients (61% in group A and only 5 patients (25% in group B (χ2=5.05; р<0.05 achieved cholesterol target level with simvastatin in dose of 20 mg daily in 3 months of the treatment. Creatine phosphokinase blood level did not increase significantly. Achievement of cholesterol target level cost 814 and 952 RUB per patient in groups A and B, respectively , in 1 month of simvastatin treatment. These costs were 643 and 417 RUB per patient in groups A and B, respectively , in 3 months of treatment. Conclusion. The original simvastatin in comparison with generic one has advantages in hypolipidemic effect. Safety profile is similar for both medications. Original simvastatin therapy has lower cost than this for generic simvastatin therapy in achievement of cholesterol target level in 1 month of treatment. In 3 months the cost of treatment per patient is 227 RUB higher for original medication in comparison with this for generic medication.

  5. The ethical landscape: identifying the right way to think about the ethical and societal aspects of synthetic biology research and products.

    Science.gov (United States)

    Yearley, Steven

    2009-08-06

    Synthetic biology promises to be highly innovative in its contribution to scientific understanding. But it offers other sorts of innovation too: in the variety of applications that could result and in the wide range of practitioners who could become involved. But directly corresponding to each of these is a kind of regulatory concern. If the entry barriers are low for a form of scientific practice with dramatic implications then the need for regulatory control over access is great since no one wants unlicensed operators releasing experimental organisms. If there are likely to be extensive opportunities for application within the human body and in the open environment (for energy production or novel forms of bioremediation) then the release and safety-testing implications are potentially enormous. Proponents of synthetic biology have been quick to realise that these challenges call for reviews of the societal and ethical aspects of synthetic biology. This paper shows that the template commonly adopted for such reviews draws on bioethics. It goes on to show that this template is far from ideal, both because of limitations in the way that bioethics has been institutionalized and because of key differences between the regulatory demands on synthetic biology and on bioethics. The paper concludes that broader models of societal and ethical review of synthetic biology are urgently required.

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

    Science.gov (United States)

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

    2014-06-01

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

  7. Segurança alimentar em produtos tradicionais Food safety in traditional products

    Directory of Open Access Journals (Sweden)

    M. E. Potes

    2007-01-01

    por um número considerável de instrumentos legislativos e gerir a segurança alimentar. São enunciadas regras de higiene integradas ao longo de toda a cadeia alimentar, tendo em vista assegurar um elevado nível de protecção da saúde pública, reduzir as barreiras comerciais e sujeitar todos os operadores do sector alimentar às mesmas regras. Além disso, são também estabelecidos instrumentos de gestão da segurança alimentar e de possíveis crises alimentares. Sem comprometer os fundamentos da segurança alimentar mencionados anteriormente, a nova legislação contemplará também os produtos tradicionais, permitindo alguma flexibilidade na aplicação das referidas regras de higiene. Esta flexibilidade deve ser exercida de forma completamente transparente em consequência da livre circulação dos produtos.There are an increasing concern from society in consuming food products that are in good conditions and, at least, do not damage human health and life. Several entities had been involved in assuring that the foods supplied to the consumers are proper and innocuous. This is the main goal of food safety, a subject analysed in “White Paper for Food Safety” (2000. This document proposed the creation, in Europe, of the European Food Authority and established a methodology based in four main principles: the characterization of the whole food chain; the traceability of foods and feeds; the responsibility of the several operators; and risk analysis. The precautionary principle and the rapid alert system are also important. Risk analysis, the base of the food safety policies, is composed by three components interconnected but performed by different entities: the risk assessment, the risk management and the risk communication. According this, the European Food Authority, named European Food Safety Agency (EFSA, is responsible by the risk analysis and by the risk communication, tasks developed in conditions of independence, excellency and transparency. The risk

  8. [Biologic age as a criterion for work evaluation (exemplified by titanium alloys production)].

    Science.gov (United States)

    Afanas'eva, R F; Prokopenko, L V

    2009-01-01

    The article deals with results of studies concerning biologic age of workers (males) under occupational hazards of titanium alloys (jeopardy classes 3.3, 3.4.4) in Verkhne-Saldinsky metallurgic production association. Based on mathematic statistic analysis, the authors worked out an equation of multiple regression for ageing pace to forecast the ageing with consideration of age, length of service, occupation. The authors determined occupational groups characterized by premature ageing and increased risk of health disorders.

  9. On learning and exploration for safety production law%安全生产法的学习与探索

    Institute of Scientific and Technical Information of China (English)

    蔡志文

    2012-01-01

    By recognizing the legislation background of the Production Safety Law and its main content, the study explores the basic principle of the Production Safety Law, and provides the definite direction and powerful guarantee for the construction safety in future.%通过认识安全生产法的立法背景和安全生产法的主要内容,对安全生产法的基本原则进行了深入研究探索,为以后的建筑施工安全工作提供了明确的方向和有力的保障。

  10. Fungi as chemical industries and genetic engineering for the production of biologically active secondary metabolites

    Institute of Scientific and Technical Information of China (English)

    Abid; Ali; Khan; Nafees; Bacha; Bashir; Ahmad; Ghosia; Lutfullah; Umar; Farooq; Russell; John; Cox

    2014-01-01

    Fungi is somewhere in between the micro and macro organisms which is a good source of producing biologically active secondary metabolites.Fungi have been used as tool for producing different types of secondary metabolites by providing different nutrients at different laboratory conditions.The fungi have been engineered for the desired secondary metabolites by using different laboratory techniques,for example,homologous and heterologous expressions.This review reported how the fungi are used as chemical industry for the production of secondary metabolites and how they are engineered in laboratory for the production of desirable metabolites:also the biosynthetic pathways of the bio-organic-molecules were reported.

  11. Fungi as chemical industries and genetic engineering for the production of biologically active secondary metabolites

    Institute of Scientific and Technical Information of China (English)

    Abid Ali Khan; Nafees Bacha; Bashir Ahmad; Ghosia Lutfullah; Umar Farooq; Russell John Cox

    2014-01-01

    Fungi is somewhere in between the micro and macro organisms which is a good source of producing biologically active secondary metabolites. Fungi have been used as tool for producing different types of secondary metabolites by providing different nutrients at different laboratory conditions. The fungi have been engineered for the desired secondary metabolites by using different laboratory techniques, for example, homologous and heterologous expressions. This review reported how the fungi are used as chemical industry for the production of secondary metabolites and how they are engineered in laboratory for the production of desirable metabolites;also the biosynthetic pathways of the bio-organic-molecules were reported.

  12. Mimicking/extracting structure and functions of natural products: synthetic approaches that address unexplored needs in chemical biology.

    Science.gov (United States)

    Hirai, Go

    2015-04-01

    Natural products are often attractive and challenging targets for synthetic chemists, and many have interesting biological activities. However, synthetic chemists need to be more than simply suppliers of compounds to biologists. Therefore, we have been seeking ways to actively apply organic synthetic methods to chemical biology studies of natural products and their activities. In this personal review, I would like to introduce our work on the development of new biologically active compounds inspired by, or extracted from, the structures of natural products, focusing on enhancement of functional activity and specificity and overcoming various drawbacks of the parent natural products.

  13. Proteomic and genomic analysis to improve the quality and safety of agricultural productions

    Directory of Open Access Journals (Sweden)

    Miriam Odoardi

    2008-04-01

    Full Text Available Food health and quality are the keywords recurring both into the VII Framework Programme of EU, both in the PNR and development plans arranged by several Italian regions. Essentially, the increase and definition of quality of agri-food products represent necessary tools to give new impulse and renovation to this sector. The late developments of European and Italian laws show a clear trend towards the need to give consumer clear indications on different qualitative aspects of agri-food products, besides their microbiological security. The capacity to increase the quantity of secondary metabolites (vitamins and antioxidants in crops is particularly interesting for the development of products with high health value (functional food. Breeding programmes have already obtained lines improved about these characteristics. The need to develop assessment strategies giving scientifically reliable information on traceability and health of food derived from genetically modified plants. Assessment of the risk coming from genetically modified plants is mainly based on the so-called “principle of substantial equivalence” or “of comparative safety”, claiming that a transgenic genotype shouldn’t show any substantial change with respect of the corresponding non-transgenic genotype. These changes are obviously considered healthy in case of the current commercial varieties. The new “-omics” disciplines such as genomics, transcriptomics, proteomics and metabolomics, born together with and subsequent to the complete sequencing of model genomes, can give an overview of first matters and food compositions, thus allowing the making of an overall assessment of their quality and safety. These new and sophisticated tools for molecular investigation can help and strengthen the commonly used methods, meeting the new requirements of traceability and authenticity certification.

  14. Current good manufacturing practice in plant automation of biological production processes.

    Science.gov (United States)

    Dorresteijn, R C; Wieten, G; van Santen, P T; Philippi, M C; de Gooijer, C D; Tramper, J; Beuvery, E C

    1997-01-01

    The production of biologicals is subject to strict governmental regulations. These are drawn up in current good manufacturing practices (cGMP), a.o. by the U.S. Food and Drug Administration. To implement cGMP in a production facility, plant automation becomes an essential tool. For this purpose Manufacturing Execution Systems (MES) have been developed that control all operations inside a production facility. The introduction of these recipe-driven control systems that follow ISA S88 standards for batch processes has made it possible to implement cGMP regulations in the control strategy of biological production processes. Next to this, an MES offers additional features such as stock management, planning and routing tools, process-dependent control, implementation of software sensors and predictive models, application of historical data and on-line statistical techniques for trend analysis and detection of instrumentation failures. This paper focuses on the development of new production strategies in which cGMP guidelines are an essential part.

  15. Construction of a microbial natural product library for chemical biology studies.

    Science.gov (United States)

    Kato, Naoki; Takahashi, Shunji; Nogawa, Toshihiko; Saito, Tamio; Osada, Hiroyuki

    2012-04-01

    The RIKEN Natural Products Depository (NPDepo) is a public depository of small molecules. Currently, the NPDepo chemical library contains 39,200 pure compounds, half of which are natural products and their derivatives. In order to reinforce the uniqueness of our chemical library, we have improved our strategies for the collection of microbial natural products. Firstly, a microbial metabolite fraction library coupled with an MP (microbial products) plot database provides a powerful resource for the efficient isolation of microbial metabolites. Secondly, biosynthetic studies of microbial metabolites have enabled us to not only access ingenious biosynthetic machineries, but also obtain a variety of biosynthetic intermediates. Our chemical library contributes to the discovery of molecular probes for increasing our understanding of complex biological processes and for eventually developing new drug leads.

  16. Impact of synthetic biology and metabolic engineering on industrial production of fine chemicals.

    Science.gov (United States)

    Jullesson, David; David, Florian; Pfleger, Brian; Nielsen, Jens

    2015-11-15

    Industrial bio-processes for fine chemical production are increasingly relying on cell factories developed through metabolic engineering and synthetic biology. The use of high throughput techniques and automation for the design of cell factories, and especially platform strains, has played an important role in the transition from laboratory research to industrial production. Model organisms such as Saccharomyces cerevisiae and Escherichia coli remain widely used host strains for industrial production due to their robust and desirable traits. This review describes some of the bio-based fine chemicals that have reached the market, key metabolic engineering tools that have allowed this to happen and some of the companies that are currently utilizing these technologies for developing industrial production processes.

  17. Microbial production of amino acids and derived chemicals: synthetic biology approaches to strain development.

    Science.gov (United States)

    Wendisch, Volker F

    2014-12-01

    Amino acids are produced at the multi-million-ton-scale with fermentative production of l-glutamate and l-lysine alone being estimated to amount to more than five million tons in the year 2013. Metabolic engineering constantly improves productivities of amino acid producing strains, mainly Corynebacterium glutamicum and Escherichia coli strains. Classical mutagenesis and screening have been accelerated by combination with intracellular metabolite sensing. Synthetic biology approaches have allowed access to new carbon sources to realize a flexible feedstock concept. Moreover, new pathways for amino acid production as well as fermentative production of non-native compounds derived from amino acids or their metabolic precursors were developed. These include dipeptides, α,ω-diamines, α,ω-diacids, keto acids, acetylated amino acids and ω-amino acids.

  18. 医院输血科生物安全管理现状及对策%Current management of biological safety in hospital blood transfusion and countermeasures

    Institute of Scientific and Technical Information of China (English)

    吴争胜; 蒋璐茜; 陈秉宇

    2011-01-01

    目的 根据浙江省输血科(血库)生物安全建设的现状,探讨进行规范化管理的方法. 方法 随机调查浙江省30所医院输血科(血库)存在的生物安全隐患,探讨制定切实可行的管理措施. 结果 综合性医院输血科生物安全管理方面存在诸多隐患,其中管理制度、操作规程等完善的合格率仅60.0%,66.7%输血科工作区布局不够合理、工作人员感染防范意识较差、医疗废弃物处理不规范等,个人防护的基本配置>90.0%,但实际使用率欠佳. 结论 必须严格执行生物安全的法律法规,制定和健全规章制度,才能确保输血科生物安全,有效预防与控制医院感染.%OBJECTIVE To approach standardized management of biological safety in blood transfusion based upon the present situation in this field in Zhejiang.METHODS A randomized survey of hidden hazardous factors threatening biological safety was conducted among the departments of blood transfusion in 30 hospitals and the data were statistically analyzed.RESULTS Several risky issues were found in the management of blood transfusion and biological safety.The qualified rate of supervising system and operating rules was only 60.0 %, unreasonable layout of workspace, poor awareness of prevention of infection, inadequate disposition of medical wastes accounted for 66.7%, staff's body sheltering was equipped over 90.0%, but the actual using rate was unexpectedly low.CONCLUSION In order to ensure the biological safety in blood transfusion and effective prevention and control of hospital infection, the relevant laws and regulations concerning biological safety should be established and strictly carried out.

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

    Science.gov (United States)

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

    2013-01-01

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

  20. 78 FR 52239 - Oil and Gas and Sulphur Operations on the Outer Continental Shelf-Oil and Gas Production Safety...

    Science.gov (United States)

    2013-08-22

    ... would be added because the hydraulic control pressure to an individual subsea well may not be able to be... subsea tree production systems on the Outer Continental Shelf (OCS) and divide the current subpart H into... following headings: General requirements; Surface and subsurface safety systems--Dry trees; Subsea...

  1. 76 FR 6765 - Consumer Product Safety Act: Notice of Commission Action on the Stay of Enforcement of Testing...

    Science.gov (United States)

    2011-02-08

    ... publication of the notice with changes. Commissioner Robert S. Adler voted against publication of the notice..., upon which date the stay will expire. FOR FURTHER INFORMATION CONTACT: Robert ``Jay'' Howell, Acting.... Stevenson, Secretary, Consumer Product Safety Commission. BILLING CODE 6355-01-P...

  2. 消费品安全法与我国产品安全相关法律的关系研究%Relation Between Consumer Product Safety Act and Laws Related to Product Safety in China

    Institute of Scientific and Technical Information of China (English)

    冯永琴; 刘红喜; 曾凌云; 张晓瑞

    2015-01-01

    Consumer product safety act is an important legal system to protect the safety of consumers. It is essential to analyze the relationship between consumer product safety act and laws related to product safety for developing the consumer product safety act. The paper analyzes the relationship from the aspects of legislative purpose, scope, stakeholder responsibility, etc., making a conclusion that the relationship can be dealt well with the good cohesion with legal responsibility, supervisory segment, adjustment range, etc., in the process.%消费品安全法是保障消费者安全的重要法律制度,厘清消费品安全法与我国产品安全相关法律法规的关系,是制定消费品安全法的前提与基础.本文在梳理我国产品安全相关法律法规的基础上,从立法宗旨、适用范围、相关方责任等方面比较分析了消费品安全法与产品安全相关法律法规的关系,提出我国消费品安全法的制定,应处理好与产品安全相关法律法规在法律责任、监管环节、调整范围上的衔接关系.

  3. A synthetic biology approach to self-regulatory recombinant protein production in Escherichia coli

    Directory of Open Access Journals (Sweden)

    Dragosits Martin

    2012-03-01

    Full Text Available Abstract Background Recombinant protein production is a process of great industrial interest, with products that range from pharmaceuticals to biofuels. Since high level production of recombinant protein imposes significant stress in the host organism, several methods have been developed over the years to optimize protein production. So far, these trial-and-error techniques have proved laborious and sensitive to process parameters, while there has been no attempt to address the problem by applying Synthetic Biology principles and methods, such as integration of standardized parts in novel synthetic circuits. Results We present a novel self-regulatory protein production system that couples the control of recombinant protein production with a stress-induced, negative feedback mechanism. The synthetic circuit allows the down-regulation of recombinant protein expression through a stress-induced promoter. We used E. coli as the host organism, since it is widely used in recombinant processes. Our results show that the introduction of the self-regulatory circuit increases the soluble/insoluble ratio of recombinant protein at the expense of total protein yield. To further elucidate the dynamics of the system, we developed a computational model that is in agreement with the observed experimental data, and provides insight on the interplay between protein solubility and yield. Conclusion Our work introduces the idea of a self-regulatory circuit for recombinant protein products, and paves the way for processes with reduced external control or monitoring needs. It demonstrates that the library of standard biological parts serves as a valuable resource for initial synthetic blocks that needs to be further refined to be successfully applied in practical problems of biotechnological significance. Finally, the development of a predictive model in conjunction with experimental validation facilitates a better understanding of the underlying dynamics and can be

  4. Biological Pretreatment of Rubberwood with Ceriporiopsis subvermispora for Enzymatic Hydrolysis and Bioethanol Production

    Directory of Open Access Journals (Sweden)

    Forough Nazarpour

    2013-01-01

    Full Text Available Rubberwood (Hevea brasiliensis, a potential raw material for bioethanol production due to its high cellulose content, was used as a novel feedstock for enzymatic hydrolysis and bioethanol production using biological pretreatment. To improve ethanol production, rubberwood was pretreated with white rot fungus Ceriporiopsis subvermispora to increase fermentation efficiency. The effects of particle size of rubberwood (1 mm, 0.5 mm, and 0.25 mm and pretreatment time on the biological pretreatment were first determined by chemical analysis and X-ray diffraction and their best condition obtained with 1 mm particle size and 90 days pretreatment. Further morphological study on rubberwood with 1 mm particle size pretreated by fungus was performed by FT-IR spectra analysis and SEM observation and the result indicated the ability of this fungus for pretreatment. A study on enzymatic hydrolysis resulted in an increased sugar yield of 27.67% as compared with untreated rubberwood (2.88%. The maximum ethanol concentration and yield were 17.9 g/L and 53% yield, respectively, after 120 hours. The results obtained demonstrate that rubberwood pretreated by C. subvermispora can be used as an alternative material for the enzymatic hydrolysis and bioethanol production.

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

    Science.gov (United States)

    Tagliabue, Giovanni

    2017-12-01

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

  6. A review of biological delignification and detoxification methods for lignocellulosic bioethanol production.

    Science.gov (United States)

    Moreno, Antonio D; Ibarra, David; Alvira, Pablo; Tomás-Pejó, Elia; Ballesteros, Mercedes

    2015-01-01

    Future biorefineries will integrate biomass conversion processes to produce fuels, power, heat and value-added chemicals. Due to its low price and wide distribution, lignocellulosic biomass is expected to play an important role toward this goal. Regarding renewable biofuel production, bioethanol from lignocellulosic feedstocks is considered the most feasible option for fossil fuels replacement since these raw materials do not compete with food or feed crops. In the overall process, lignin, the natural barrier of the lignocellulosic biomass, represents an important limiting factor in biomass digestibility. In order to reduce the recalcitrant structure of lignocellulose, biological pretreatments have been promoted as sustainable and environmentally friendly alternatives to traditional physico-chemical technologies, which are expensive and pollute the environment. These approaches include the use of diverse white-rot fungi and/or ligninolytic enzymes, which disrupt lignin polymers and facilitate the bioconversion of the sugar fraction into ethanol. As there is still no suitable biological pretreatment technology ready to scale up in an industrial context, white-rot fungi and/or ligninolytic enzymes have also been proposed to overcome, in a separated or in situ biodetoxification step, the effect of the inhibitors produced by non-biological pretreatments. The present work reviews the latest studies regarding the application of different microorganisms or enzymes as useful and environmentally friendly delignification and detoxification technologies for lignocellulosic biofuel production. This review also points out the main challenges and possible ways to make these technologies a reality for the bioethanol industry.

  7. The reduction of biological production induced by mesoscale mixing: a modelling study in the Benguela upwelling

    CERN Document Server

    Hernández-Carrasco, Ismael; Hernández-García, Emilio; Garçon, Veronique; López, Cristóbal

    2013-01-01

    Recent studies, both based on remote sensed data and coupled models, showed a reduction of biological productivity due to vigorous horizontal mixing in upwelling systems. In order to better understand this phenomenon, we have considered a system of oceanic flow in the Benguela area coupled with a simple biogeochemical model of Nutrient-Phyto-Zooplankton (NPZ) type. For the flow three different surface velocity fields are considered: one derived from satellite altimetry data, and the other two from a regional numerical model at two different spatial resolutions. We computed horizontal particle dispersion in terms of Lyapunov Exponents, and analyzed their correlations with phytoplankton concentrations. Our modelling approach confirms that in the south Benguela, there is a reduction of biological activity when stirring is increased. Two-dimensional offshore advection seems to be the dominant process involved. In the northern area, other factors not taken into account in our simulation are influencing the ecosyst...

  8. Application of synthetic biology for production of chemicals in yeast Saccharomyces cerevisiae

    DEFF Research Database (Denmark)

    Borodina, Irina; Li, Mingji

    2015-01-01

    Synthetic biology and metabolic engineering enable generation of novel cell factories that efficiently convert renewable feedstocks into biofuels, bulk, and fine chemicals, thus creating the basis for biosustainable economy independent on fossil resources. While over a hundred proof...... computational tools for the prediction of biochemical pathways, molecular biology methods for assembly of DNA parts into pathways, and for introducing the pathways into the host, and finally approaches for optimizing performance of the introduced pathways.......-of-concept chemicals have been made in yeast, only a very small fraction of those has reached commercial-scale production so far. The limiting factor is the high research cost associated with the development of a robust cell factory that can produce the desired chemical at high titer, rate, and yield. Synthetic...

  9. Alien Biochemistries and Their Metabolic By-Products. Lessons from Synthetic Biology

    Science.gov (United States)

    Benner, S.

    2014-03-01

    While the metabolisms of terran organisms are accessible for study and their byproducts are, for the most part, well known, the "diversity" of terran biology arises (as far as we know) from a single common ancestor, represents only a small fraction of possible chemical difersity, and may reflect only a fraction of the possible chemical diversity that might support Darwinian evolution [1]. This talk will consider laboratory experiments on origins [2] and synthetic biology [3], asking how they might inform us about alternative biochemistries, and whether we have any chance of observing remotely their by-products, recognizing the uncertanties in both our models for "weird life" and our models of abiotic processes in incompletely defined planetary environments.

  10. Enzyme and metabolic engineering for the production of novel biopolymers: crossover of biological and chemical processes.

    Science.gov (United States)

    Matsumoto, Ken'ichiro; Taguchi, Seiichi

    2013-12-01

    The development of synthetic biology has transformed microbes into useful factories for producing valuable polymers and/or their precursors from renewable biomass. Recent progress at the interface of chemistry and biology has enabled the production of a variety of new biopolymers with properties that substantially differ from their petroleum-derived counterparts. This review touches on recent trials and achievements in the field of biopolymer synthesis, including chemo-enzymatically synthesized aliphatic polyesters, wholly biosynthesized lactate-based polyesters, polyhydroxyalkanoates and other unusual bacterially synthesized polyesters. The expanding diversities in structure and the material properties of biopolymers are key for exploring practical applications. The enzyme and metabolic engineering approaches toward this goal are discussed by shedding light on the successful case studies.

  11. Removal of disinfection by-product formation potentials by biologically assisted GAC treatment

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    The object of this paper is to evaluate the removal of disinfection by-products formation potential by artificially intensified biological activated carbon(BAC) process which is developed on the basis of traditional ozone granular activated carbon (GAC). The results show that 23.1% of trihalomethane formation potential (THMFP) and 68% of haloacetic acid formation potential (HAAFP) can be removed by BAC,respectively. Under the same conditions, the removal rates of the same substances were 12.2% and 13-25 % respectively only by GAC process. Compared with GAC, the high removal rates of the two formed potential substances were due to the increasing of bioactivity of the media and the synergistic capabilities of biological degradation cooperating with activated carbon adsorption of organic compounds. BAC process has some advantages such as long backwashing cycle time, low backwashing intensity and prolonged activated carbon lifetime, etc.

  12. An integral safety approach for design of high risk products and systems

    NARCIS (Netherlands)

    Rajabalinejad, M.; Bonnema, G.M.; Houten, van F.J.A.M.; Podofilini, Luca; Sudret, Bruno; Stojadinovic, Bozidar; Zio, Enrico; Kröger, Wolfgang

    2015-01-01

    To make the world a safer place while adapting high-end technologies, engineers have to address societal concerns about the safety of emerging high-tech systems. While adapting services provided by technology, people concern about their safety. It seems that engineers are struggling to control the f

  13. A Effect of Biological Pollution on Food Safety%生物性污染对食品安全的影响

    Institute of Scientific and Technical Information of China (English)

    孙若玉; 任亚妮; 张斌

    2015-01-01

    生物性污染是威胁食品安全和人们身心健康的重要因素之一,主要包括细菌性污染、病毒性污染、真菌和真菌毒素污染、水产中的生物毒素、寄生虫与害虫污染几个方面。通过对食品生物性污染来源分析,提出相应的预防措施,为有效保证食品安全工作提供依据。%The biological pollution was one of the important factors that threaten food safety and people's physical and mental health,which including bacterial pollution, viral contamination, fungal and mycotoxin contamination, biological toxin in aquaculture, parasites and pests and so on. Through the analysis of the biological pollution, We put forward the corresponding prevention measures, provide the basis for effective guarantee food safety work.

  14. A cell-free expression and purification process for rapid production of protein biologics.

    Science.gov (United States)

    Sullivan, Challise J; Pendleton, Erik D; Sasmor, Henri H; Hicks, William L; Farnum, John B; Muto, Machiko; Amendt, Eric M; Schoborg, Jennifer A; Martin, Rey W; Clark, Lauren G; Anderson, Mark J; Choudhury, Alaksh; Fior, Raffaella; Lo, Yu-Hwa; Griffey, Richard H; Chappell, Stephen A; Jewett, Michael C; Mauro, Vincent P; Dresios, John

    2016-02-01

    Cell-free protein synthesis has emerged as a powerful technology for rapid and efficient protein production. Cell-free methods are also amenable to automation and such systems have been extensively used for high-throughput protein production and screening; however, current fluidic systems are not adequate for manufacturing protein biopharmaceuticals. In this work, we report on the initial development of a fluidic process for rapid end-to-end production of recombinant protein biologics. This process incorporates a bioreactor module that can be used with eukaryotic or prokaryotic lysates that are programmed for combined transcription/translation of an engineered DNA template encoding for specific protein targets. Purification of the cell-free expressed product occurs through a series of protein separation modules that are configurable for process-specific isolation of different proteins. Using this approach, we demonstrate production of two bioactive human protein therapeutics, erythropoietin and granulocyte-macrophage colony-stimulating factor, in yeast and bacterial extracts, respectively, each within 24 hours. This process is flexible, scalable and amenable to automation for rapid production at the point-of-need of proteins with significant pharmaceutical, medical, or biotechnological value.

  15. Biologically active amines in fermented and non-fermented commercial soybean products from the Spanish market.

    Science.gov (United States)

    Toro-Funes, N; Bosch-Fuste, J; Latorre-Moratalla, M L; Veciana-Nogués, M T; Vidal-Carou, M C

    2015-04-15

    Biologically active amines were determined in commercial soybean products. The antioxidant polyamines were found in both non-fermented and fermented soybean products. Natto and tempeh showed the highest content of polyamines (75-124 and 11-24 mg/kg of spermidine and spermine, respectively). On the other hand, the bacterial-related biogenic amines, tyramine, histamine, tryptamine and β-phenylethylamine, were detected in practically all fermented products with a high variability. The highest contents were found in sufu, tamari and soybean paste. Extremely high tyramine and histamine contents, 1700 and 700 mg/kg, respectively, found in some sufu samples could be unhealthy. However, biogenic amines observed in the other soybean products should not be a risk for healthy consumers. However, individuals who take monoamine and diamine oxidase inhibitors drugs should be strongly recommended to avoid this kind of products in order to suffer no adverse health effects. These biogenic amines were not detected in non-fermented soybean products.

  16. The Research Status of Synthetic Biology Safety Ethics%合成生物学安全伦理研究现状

    Institute of Scientific and Technical Information of China (English)

    钱万强; 墨宏山; 闫金定; 张敏

    2013-01-01

    近年来合成生物学取得了突破性进展,然而,公众在关注合成生物学突破的同时,也陷入了对其安全性的担忧。本文阐述了合成生物学的概念及其发展途径,分析了国外政府和科研机构对于合成生物学安全性的考虑,并提出了针对我国合成生物学理性发展的建议。%Synthetic biology achieves a breakthrough in recent years.The public have been paying attention to the breakthroughs of synthetic biology as well as lost in wor-ries about its safety .In this paper , we expound the con-cept of synthetic biology and its development pathway , analyze the security considerations of foreign govern-ments and research institutions on synthetic biology , and puts forward suggestions for rational development of synthetic biology in China .

  17. Degeneration of penicillin production in ethanol-limited chemostat cultivations of Penicillium chrysogenum: A systems biology approach

    NARCIS (Netherlands)

    Douma, R.D.; Batista, J.M.; Touw, K.M.; Kiel, J.A.K.W.; Krikken, A.M.; Zhao, Z.; Veiga, T.; Klaassen, P.; Bovenberg, R.A.L.; Daran, J.M.; Heijnen, J.J.; Van Gulik, W.M.

    2011-01-01

    Background In microbial production of non-catabolic products such as antibiotics a loss of production capacity upon long-term cultivation (for example chemostat), a phenomenon called strain degeneration, is often observed. In this study a systems biology approach, monitoring changes from gene to pro

  18. The scientific production in health and biological sciences of the top 20 Brazilian universities

    Directory of Open Access Journals (Sweden)

    R. Zorzetto

    2006-12-01

    Full Text Available Brazilian scientific output exhibited a 4-fold increase in the last two decades because of the stability of the investment in research and development activities and of changes in the policies of the main funding agencies. Most of this production is concentrated in public universities and research institutes located in the richest part of the country. Among all areas of knowledge, the most productive are Health and Biological Sciences. During the 1998-2002 period these areas presented heterogeneous growth ranging from 4.5% (Pharmacology to 191% (Psychiatry, with a median growth rate of 47.2%. In order to identify and rank the 20 most prolific institutions in these areas, searches were made in three databases (DataCAPES, ISI and MEDLINE which permitted the identification of 109,507 original articles produced by the 592 Graduate Programs in Health and Biological Sciences offered by 118 public universities and research institutes. The 20 most productive centers, ranked according to the total number of ISI-indexed articles published during the 1998-2003 period, produced 78.7% of the papers in these areas and are strongly concentrated in the Southern part of the country, mainly in São Paulo State.

  19. Studies of the Production of Fungal Polyketides in Aspergillus nidulans by Using Systems Biology Tools

    DEFF Research Database (Denmark)

    Panagiotou, Gianni; Andersen, Mikael Rørdam; Grotkjær, Thomas

    2009-01-01

    -methylsalicylic acid (6-MSA) synthase gene and one expressing the 6-MSA synthase gene and overexpressing the native xylulose-5-phosphate phosphoketolase gene (xpkA) for increasing the pool of polyketide precursor levels. The physiology of the recombinant strains and that of a reference wild-type strain were...... that overexpression of xpkA does not directly improve 6-MSA production on glucose, but it is possible, if the metabolic flux through the lower part of glycolysis is reduced, to obtain quite high yields for conversion of sugar to 6-MSA. Systems biology tools were employed for in-depth analysis of the metabolic...

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

    Science.gov (United States)

    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.

  1. 车工作业安全生产的研究%Turner research work of production safety

    Institute of Scientific and Technical Information of China (English)

    张继森

    2014-01-01

    现代社会的发展使得生产作业由原先的老式人工作业逐渐转变为机械作业加人工操作的模式,机械的高速生产模式加上人工的精准操作使得生产精准、高速,进而提升了社会市场经济的快速发展。机械操作中的安全就更为重要。文章就从车工作业有哪些需要注意的安全方面以及安全生产的操作规章进行论述。%The development of modern society makes the production from gradually transforms the old manual operation of machinery operation and manual operation mode, mechanical precision high-speed production mode combined with artificial operation makes the production of precision, high speed, which promoted the rapid development of social market economy. Mechanical operation of safety is more important. This article from the lathe work assignments which need to be aware of safety and production safety operating rules is discussed.

  2. Long-term organic farming fosters below and aboveground biota: Implications for soil quality, biological control and productivity

    NARCIS (Netherlands)

    Birkhofer, K.; Bezemer, T.M.; Bloem, J.; Bonkowski, M.; Christensen, S.; Dubois, D.; Ekelund, F.; Fliessbach, A.; Gunst, L.; Hedlund, K.; Mäder, P.; Mikola, J.; Robin, C.; Setälä, H.; Tatin-Froux, F.; Putten, van der W.H.; Scheu, S.

    2008-01-01

    Organic farming may contribute substantially to future agricultural production worldwide by improving soil quality and pest control, thereby reducing environmental impacts of conventional farming. We investigated in a comprehensive way soil chemical, as well as below and aboveground biological param

  3. Suppressing and enhancing effects of mesoscale dynamics on biological production in the Mozambique Channel

    Science.gov (United States)

    José, Y. S.; Penven, P.; Aumont, O.; Machu, E.; Moloney, C. L.; Shillington, F.; Maury, O.

    2016-06-01

    We used a coupled physical-biogeochemical model to investigate how the strong eddy activity typical of the Mozambique Channel affects biological production. A numerical experiment was carried out, in which mesoscale dynamics were suppressed by cancelling the nonlinear terms for horizontal momentum in the Naviers-Stokes equation. Mesoscale dynamics were found to be responsible for (1) increased offshore production in the Mozambique Channel as a result of net eddy-induced offshore transport of nutrient-rich coastal waters; (2) decreased shelf production along the central Mozambican and south-west Madagascar coast caused by a reduction in nutrient availability related to the net eddy-induced lateral transport of nutrients; (3) increased coastal production along the northern Mozambican coast caused by eddy-induced nutrient supply. The model results also showed an intensification and shallowing of the subsurface production, related to increased upper layer nutrient concentrations caused by eddy activity. In addition, by driving the detachment of the East Madagascar Current at the southern tip of the island, inertial processes intensify the southern Madagascar upwelling and causes offshore diffusion of the upwelled waters. These results emphasize the complex role played by eddy activity and, more generally, inertial processes on marine ecosystems in this region.

  4. [The pharmaceutical company Choay: an history linked to research and commercialization of biological products].

    Science.gov (United States)

    Bonnemain, Bruno

    2015-12-01

    Eugène Choay, when he created his own company in 1911, had already a large experience in pharmaceutical industry obtained with Maison Frère where he discovered the famous Dentol, well known thank to Poulbot's publicity drawings for this product. But, convinced of the future of biological products and Opotherapy, he decided to invest himself in this area with a totally new process for cold desiccation of organs. The success will be there and several pharmacists from Choay family will take care of the company and bring it to the top of its specialty in Opotherapy. At the beginning of the 1970's, Choay in in full development and has the products, the sites and the human resources for the future. In 1975, 4 therapeutic areas are covered by Choay's products: coagulation, inflammation, dermatology and hepatology. After more than 65 years of independence, Choay group will be finally bought partially and then totally by Sanofi. With the support of Sanofi, Choay created, in 1981, their US subsidiary called Choay Laboratories Inc;, after the NDA approval of sub-cutaneous Calciparine by the FDA. In 1985 Fraxiparine, a low molecular weight heparin discovered by Jean Choay's team, is lauched on the market. All these developments represent an outstanding record a longevity which indicates how perceptive was Eugène Choay and his successors when choosing to invest totally in the therapeutic use of hormones and products acting on coagulation factors.

  5. Biological characteristics of marine bacterium S - 9801 strain and its culture conditions of pigment production

    Institute of Scientific and Technical Information of China (English)

    田黎; 何培青; 武洪庆; 温占波; 刘晨临; 李光友

    2002-01-01

    Strain of Flavobacterium sp. (S- 9801), was screened from 207 strains of marine bacteria isolated from the Bohai Sea continental shelf and the Zhujiang Estuary, for its red pigment production. The biological characteristics of strain S- 9801 and culture conditions of pigment production have been checked out in this study. The color of the bacterial colony on 2216E medium was from coccineus to rose bengal. Optimum culture conditions were sodium chloride concentration(g/dm3), 10~30; pH,3~8; temperature, 25~28℃; tryptone and yeast extract as nitrogen sources and gluccse as carbon source. Under optimum conditions, pigment accumulation started after 12 h, reaching a maximum rate of synthesis at 36 h.

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

    Science.gov (United States)

    2005-01-01

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

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

    Science.gov (United States)

    Heinrich, Michael

    2015-07-01

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

  8. Comparison of long-term drug survival and safety of biologic agents in patients with psoriasis vulgaris

    DEFF Research Database (Denmark)

    Gniadecki, R; Bang, B; Bryld, L E

    2015-01-01

    a significantly longer drug survival than the anti-TNF-α agents. Switching from one biologic to another is associated with an impairment of drug survival. Preventing loss of efficacy is a major area of medical need in the biologic therapy of psoriasis and the strategies that improve drug survival should......BACKGROUND: Drug survival (time to drug discontinuation) has recently emerged as an important parameter reflecting the long-term therapeutic performance in a real-life setting. Biologic drug survival in psoriasis is mainly limited by a gradual loss of efficacy over time. Previous studies have been...... limited by small patient population size and short observation times and yielded discrepant survival times for different biologics. OBJECTIVES: To calculate the long-term drug survival for adalimumab, etanercept, infliximab and ustekinumab in a large cohort of real-life patients with psoriasis vulgaris...

  9. Connecting marine productivity to sea-spray via nanoscale biological processes: Phytoplankton Dance or Death Disco?

    Science.gov (United States)

    O'Dowd, Colin; Ceburnis, Darius; Ovadnevaite, Jurgita; Bialek, Jakub; Stengel, Dagmar B.; Zacharias, Merry; Nitschke, Udo; Connan, Solene; Rinaldi, Matteo; Fuzzi, Sandro; Decesari, Stefano; Cristina Facchini, Maria; Marullo, Salvatore; Santoleri, Rosalia; Dell'Anno, Antonio; Corinaldesi, Cinzia; Tangherlini, Michael; Danovaro, Roberto

    2015-10-01

    Bursting bubbles at the ocean-surface produce airborne salt-water spray-droplets, in turn, forming climate-cooling marine haze and cloud layers. The reflectance and ultimate cooling effect of these layers is determined by the spray’s water-uptake properties that are modified through entrainment of ocean-surface organic matter (OM) into the airborne droplets. We present new results illustrating a clear dependence of OM mass-fraction enrichment in sea spray (OMss) on both phytoplankton-biomass, determined from Chlorophyll-a (Chl-a) and Net Primary Productivity (NPP). The correlation coefficient for OMss as a function of Chl-a increased form 0.67 on a daily timescale to 0.85 on a monthly timescale. An even stronger correlation was found as a function of NPP, increasing to 0.93 on a monthly timescale. We suggest the observed dependence is through the demise of the bloom, driven by nanoscale biological processes (such as viral infections), releasing large quantities of transferable OM comprising cell debris, exudates and other colloidal materials. This OM, through aggregation processes, leads to enrichment in sea-spray, thus demonstrating an important coupling between biologically-driven plankton bloom termination, marine productivity and sea-spray modification with potentially significant climate impacts.

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

    Science.gov (United States)

    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

  11. Long-term organic farming fosters below and aboveground biota: Implications for soil quality, biological control and productivity

    DEFF Research Database (Denmark)

    Birkhofer, K.; Bezemer, TM; Bloem, J;

    2008-01-01

     Organic farming may contribute substantially to future agricultural production worldwide by improving soil quality and pest control, thereby reducing environmental impacts of conventional farming. We investigated in a comprehensive way soil chemical, as well as below and aboveground biological...... promoting negative environmental impacts of agriculture by reducing internal biological cycles and pest control. On the contrary, organic farming fosters microbial and faunal decomposers and this propagates into the aboveground system via generalist predators thereby increasing conservation biological...... control. However, grain and straw yields were 23% higher in systems receiving mineral fertilizers and herbicides reflecting the trade-off between productivity and environmental responsibility....

  12. Clinical trials with allergen products: in search of biological markers of efficacy.

    Science.gov (United States)

    Moingeon, Philippe

    2006-01-01

    I discuss herein our efforts to identify biological markers of efficacy in support of the development of sublingual allergy vaccines. Biomarkers are of major interest to facilitate clinical development, for example by predicting safety and efficacy of candidate vaccines or their components (e.g. adjuvants and formulations) on the basis of immunogenicity evaluated in humans. They will be mandatory in the future to evaluate customized recombinant allergy vaccines designed upon component-resolved diagnosis. In this regard, they must ideally be both qualitative and quantitative. Such markers would also be useful to confirm foreseen mechanisms of action potentially associated with successful immunotherapy (e.g. the Treg hypothesis). The recent availability of sophisticated technologies (referred here as the technology push) to assess in details both humoral and cellular arms of the immune system provides new opportunities to identify such markers. In this regard, documenting natural immune responses, most particularly allergen-specific T cell responses in healthy persons, is critical to identify immunological correlates of protection, and thus to design optimal allergy vaccines.

  13. Safety assessment of genetically modified foods.

    Science.gov (United States)

    Taylor, S L

    2001-12-01

    The development of novel foods produced through agricultural biotechnology is a complex three-stage process: gene discovery, line selection, and product advancement to commercialization. The safety of genetically modified foods is an integral part of the overall developmental process throughout all of the stages. In the discovery stage, the safety of the gene, its source, and the gene products must be considered. If any questions arise at this stage, these questions must be answered later in the developmental process. During the line selection stage, the genetically modified seed progresses through a variety of greenhouse and field trials. At this stage, the biological and agronomic equivalence of the genetically modified crop to its traditional counterpart must be compared. While the evaluations made during this stage are not specifically directed toward a safety assessment, many potential products with unusual characteristics are eliminated during this stage of development. However, the elimination of products with unusual agronomic or biological characteristics enhances the likelihood that a safe product will be generated. Finally, in the pre-commercialization stage, the genetically modified product undergoes a detailed safety assessment process. This process focuses on the safety of the gene products associated with the introduced gene and any other likely toxicological or anti-nutrient factors associated with the source of the novel gene and the crop to which it was introduced. The safety of the genetically modified product for both food and feed uses is considered. Thus far, all of the genetically modified products brought into the marketplace have been subjected to such an intensive safety assessment. The safety assessment data have been reviewed by regulatory authorities around the world. The current generation of genetically modified products are quite safe for human and feed animal consumption.

  14. Biomarkers in natural fish populations indicate adverse biological effects of offshore oil production.

    Directory of Open Access Journals (Sweden)

    Lennart Balk

    Full Text Available BACKGROUND: Despite the growing awareness of the necessity of a sustainable development, the global economy continues to depend largely on the consumption of non-renewable energy resources. One such energy resource is fossil oil extracted from the seabed at offshore oil platforms. This type of oil production causes continuous environmental pollution from drilling waste, discharge of large amounts of produced water, and accidental spills. METHODS AND PRINCIPAL FINDINGS: Samples from natural populations of haddock (Melanogrammus aeglefinus and Atlantic cod (Gadus morhua in two North Sea areas with extensive oil production were investigated. Exposure to and uptake of polycyclic aromatic hydrocarbons (PAHs were demonstrated, and biomarker analyses revealed adverse biological effects, including induction of biotransformation enzymes, oxidative stress, altered fatty acid composition, and genotoxicity. Genotoxicity was reflected by a hepatic DNA adduct pattern typical for exposure to a mixture of PAHs. Control material was collected from a North Sea area without oil production and from remote Icelandic waters. The difference between the two control areas indicates significant background pollution in the North Sea. CONCLUSION: It is most remarkable to obtain biomarker responses in natural fish populations in the open sea that are similar to the biomarker responses in fish from highly polluted areas close to a point source. Risk assessment of various threats to the marine fish populations in the North Sea, such as overfishing, global warming, and eutrophication, should also take into account the ecologically relevant impact of offshore oil production.

  15. Biological effects of activation products and other chemicals released from fusion power plants

    Energy Technology Data Exchange (ETDEWEB)

    Strand, J.A.; Poston, T.M.

    1976-09-01

    Literature reviews indicate that existing information is incomplete, often contradictory, and of questionable value for the prediction and assessment of ultimate impact from fusion-associated activation products and other chemical releases. It is still uncertain which structural materials will be used in the blanket and first wall of fusion power plants. However, niobium, vanadium, vanadium-chromium alloy, vanadium-titanium alloy, sintered aluminum product, and stainless steel have been suggested. The activation products of principal concern will be the longer-lived isotopes of /sup 26/Al, /sup 49/V, /sup 51/Cr, /sup 54/Mn, /sup 55/Fe, /sup 58/Co, /sup 60/Co, /sup 93/Nb, and /sup 94/Nb. Lithium released to the environment either during the mining cycle, from power plant operation or accident, may be in the form of a number of compound types varying in solubility and affinity for biological organisms. The effects of a severe liquid metal fire or explosion involving Na or K will vary according to inherent abiotic and biotic features of the affected site. Saline, saline-alkaline, and sodic soils of arid lands would be particularly susceptible to alkaline stress. Beryllium released to the environment during the mining cycle or reactor accident situation could be in the form of a number of compound types. Adverse effects to aquatic species from routine chemical releases (biocides, corrosion inhibitors, dissolution products) may occur in the discharge of both fission and fusion power plant designs.

  16. Biological water contamination in some cattle production fields of Argentina subjected to runoff and erosion

    Directory of Open Access Journals (Sweden)

    Celio I. Chagas

    2014-10-01

    Full Text Available Grain production has displaced livestock to marginal lands in most of the productive regions in Argentina since 1990. In the fertile Rolling Pampa region, extensive cattle production has been concentrated in lowlands subjected to flooding, salt excess, erosion and sedimentation processes but also in some feedlots recently located in sloping arable lands prone to soil erosion. We studied the concentration of microbiological contamination indicators in runoff water and sediments accumulated in depressions along the tributary network from these lands devoted to cattle production. The aims of this work were: (i to gather a reliable set of data from different monitoring periods and scales, (ii to search for simple and sensible variables to be used as indicators for surface water quality advising purposes and (iii to corroborate previous biological contamination conceptual models for this region. Concentration of pollution indicators in these ponds was related to mean stocking rates from nearby fields and proved to depend significantly on the accumulated water and sediments. Viable mesophiles and total coliforms were found mainly attached to large sediments rather than in the runoff water phase. Seasonal sampling showed that the time period between the last significant runoff event and each sampling date regarding enterococci proved to be a sensible variable for predicting contamination. Enterococci concentration tended to increase gradually until the next extraordinary runoff event washed away contaminants. The mentioned relationship may be useful for designing early warning surface water contamination programs regarding enterococci dynamics and other related microbial pollutants as well.

  17. The CE-mark and the new European approach to product law: a system of fundamental legal safety requirements and technical specification standards

    NARCIS (Netherlands)

    Brack, Antoni

    1999-01-01

    European product law consists of three parts: product liability law, a general product safety regulation and an increasing number of provisions with requirements on product group level. In recent years this third part has been revised in order to speed up the completion of the European single market

  18. The great 2012 Arctic Ocean summer cyclone enhanced biological productivity on the shelves.

    Science.gov (United States)

    Zhang, Jinlun; Ashjian, Carin; Campbell, Robert; Hill, Victoria; Spitz, Yvette H; Steele, Michael

    2014-01-01

    [1] A coupled biophysical model is used to examine the impact of the great Arctic cyclone of early August 2012 on the marine planktonic ecosystem in the Pacific sector of the Arctic Ocean (PSA). Model results indicate that the cyclone influences the marine planktonic ecosystem by enhancing productivity on the shelves of the Chukchi, East Siberian, and Laptev seas during the storm. Although the cyclone's passage in the PSA lasted only a few days, the simulated biological effects on the shelves last 1 month or longer. At some locations on the shelves, primary productivity (PP) increases by up to 90% and phytoplankton biomass by up to 40% in the wake of the cyclone. The increase in zooplankton biomass is up to 18% on 31 August and remains 10% on 15 September, more than 1 month after the storm. In the central PSA, however, model simulations indicate a decrease in PP and plankton biomass. The biological gain on the shelves and loss in the central PSA are linked to two factors. (1) The cyclone enhances mixing in the upper ocean, which increases nutrient availability in the surface waters of the shelves; enhanced mixing in the central PSA does not increase productivity because nutrients there are mostly depleted through summer draw down by the time of the cyclone's passage. (2) The cyclone also induces divergence, resulting from the cyclone's low-pressure system that drives cyclonic sea ice and upper ocean circulation, which transports more plankton biomass onto the shelves from the central PSA. The simulated biological gain on the shelves is greater than the loss in the central PSA, and therefore, the production on average over the entire PSA is increased by the cyclone. Because the gain on the shelves is offset by the loss in the central PSA, the average increase over the entire PSA is moderate and lasts only about 10 days. The generally positive impact of cyclones on the marine ecosystem in the Arctic, particularly on the shelves, is likely to grow with increasing

  19. Study on Separation of Factors of Production from Grain and Food Safety during the Evolution of Chinese Agricultural Structure

    Institute of Scientific and Technical Information of China (English)

    Kangkang; SHAN; Anran; WANG

    2015-01-01

    China is the world’s largest food producer,and it also has the largest food demand. The stability of China’s food production directly affects the supply and demand situation of the world food market. In the context of evolving Chinese agricultural structure,this paper studies the separation of factors of production from grain and issues concerning food safety. It is found that the arable land for food production within agricultural sector continues to flow to non-food production sector while the arable land is shrinking in China; the process of urbanization of population is the main reason for food production workforce reduction,resulting in a decline in the overall quality of the food production labor.By analyzing the panel data estimation results for food production function,it is found that arable land and labor are still important factors for food production in China at present,and their flow out of food production poses a major threat to food production and security.

  20. Determination of production biology of cladocera in a reservoir receiving hyperthermal effluents from a nuclear production reactor. [Par Pond

    Energy Technology Data Exchange (ETDEWEB)

    Vigerstad, T J

    1980-01-01

    The effects on zooplankton of residence in a cooling reservoir receiving hyperthermal effluents directly from a nuclear-production-reactor were studied. Rates of cladoceran population production were compared at two stations in the winter and summer of 1976 on Par Pond located on the Savannah River Plant, Aiken, SC. One station was located in an area of the reservoir directly receiving hyperthermal effluent (Station MAS) and the second was located about 4 km away in an area where surface temperatures were normal for reservoirs in the general geographical region (Station CAS). A non-parametric comparison between stations of standing stock and fecundity data for Bosmina longirostris, taken for the egg ratio model, was used to observe potential hyperthermal effluent effects. There was a statistically higher incidence of deformed eggs in the Bosmina population at Station MAS in the summer. Bosmina standing stock underwent two large oscillations in the winter and three large oscillations in the summer at Station MAS compared with two in the winter and one in the summer at Station CAS. These results are consistent with almost all other Par Pond studies which have found the two stations to be essentially similar in spectra composition but with some statistically significant differences in various aspects of the biology of the species.