Rozprawy doktorskie na temat „Biosafety”

High containment laboratories play an important role in modern society allowing for the research and diagnosis of high-risk pathogens and infectious diseases whilst ensuring protection from unintentional harm to the local community as a result of escaped pathogens. This thesis focuses on the third function, investigating pressure integrity testing. A thorough literature review of biocontainment has been conducted to present the scientific knowledge in the area and identify knowledge gaps. The theoretical background of the current integrity tests was derived, and using the resulting mathematical formulas, a comparison of the theoretical prediction of common pressure integrity tests was conducted. Furthermore, real pressure integrity testing data from a state of the art Biosafety Level 4 (BSL-4) laboratory was analysed. The literature review and the numerical analysis identified key limitations of the current tests, showing the need for a new testing methodology. This study contributes to science by introducing a new pressure integrity testing methodology for high containment laboratories taking into consideration biocontainment and fumigation requirements. Furthermore, the most common leakage points in containment laboratories have been identified though a thorough in-situ investigation conducted at the commissioning stage of one of the largest biomedical facilities in the world. This study suggests that gross leaks are due to a failure in construction details and identifies the importance of quality assurance at the construction stage. Also, case studies based on the work conducted with Laing O'Rourke (the Industrial Sponsor of this EngD) are presented demonstrating the industrial application of this Doctorate in pressure integrity testing of high containment laboratories. It is expected by the Author that this research will have an impact on the industry as it can contribute to the establishment of a regulation controlling the airtightness levels of high containment laboratories, which could be implemented by the Health and Safety Executive (HSE) to ensure that high containment laboratories in the UK provide safe environments for the study of high-risk agents and infectious diseases.

Thesis (MA)--University of Stellenbosch, 2001.
ENGLISH ABSTRACT: The development of the global biotechnology industry largely coincided with the development of the US biotechnology industry. This resulted in this industry's oligopolistic and centralised nature where only a few multinational chemical and pharmaceutical companies control most biotechnology processes and production of commodities emanating from these processes. The governance of biotechnology has, until recently, been dominated by state actors who have endeavoured to secure national interests, including those of large multinational corporations (MNCs) based within their boundaries. The technological ability of developed states to exploit and use unevenly distributed resources to their advantage means that an uneven relationship exists between these and poor developing countries. This has been highlighted by differences in public opinion about the role and application of biotechnology in society. While some opinions favour the use and application of biotechnology to enhance food supplies and boost production levels and trade, other opinions caution against the possible hazards that genetically manipulated organisms (GMOs) hold for the environment and human existence. The commercialisation of biotechnology has resulted in the exponential growth of genetically manipulated crops in especially the United States and countries like Argentina and Canada. These countries produce large surpluses of staple grains such as corn and soya and try to sell these to countries with food supply problems. The clash in commercial interests stemming from developed countries' insistence on the protection of intellectual property rights (IPR) on genetically manipulated (GM) seeds has caused considerable conflict with poor farmers who will not be able to sustain their livelihoods if they cannot save seeds for future harvests. This is one aspect of the problems surrounding the protection of knowledge products that is exacerbated by the scientific uncertainty pertaining to the risk involved with biotechnology. While some observers agitate for precaution with the use of GMOs, others feel that a lack of scientific proof of harm is sufficient grounds for proceeding with developments in biotechnology. Conversely, there are some that feel that biotechnology is market driven instead of human needs driven, ultimately resulting in developing countries receiving very little benefit from it. The Cartagena Protocol on biosafety was drafted to address some of the difficulties involved with the transboundary movement of GMOs. Although it holds very specific advantages for developing countries, as a regulatory framework it is limited in its scope and application. Developing countries are limited in their policy options to address their need to protect biodiversity and secure their food supply. This means that considerable challenges and constraints await these countries in utilising global governance of public goods and building their human and technological capacities.
AFRIKAANSE OPSOMMING: Die ontwikkeling van die globale biotegnologie-industrie het grootliks saamgeval met die ontwikkeling van die Verenigde State se biotegnologie-industrie. Dit het aanleiding gegee tot hierdie industrie se oligopolistiese en gesentraliseerde aard waar slegs enkele multinasionale chemiese en farmaseutiese maatskappye die meeste biotegnologie prosesse en die vervaardiging van kommoditeite uit daardie prosesse beheer. Die regering van biotegnologie was tot onlangs oorheers deur staatsakteurs wie gepoog het om nasionale belange te beskerm, insluitend die belange van multinasionale korporasies (MNK) wat vanuit hulle grondgebied funksioneer. Die tegnologiese vermoë van ontwikkelde state om oneweredig verspreide hulpbronne tot eie gewin te benut beteken dat 'n ongelyke verhouding bestaan tussen hierdie en arm ontwikkelende state. Dit word beklemtoon deur verskille in openbare mening oor die rol en aanwending van biotegnologie in die samelewing. Terwyl sekere opinies ten gunste van die aanwending van biotegnologie vir die verbetering van voedselbronne en produksievlakke en handel is, dui ander opinies op die moontlike gevare wat geneties gemanipuleerde organismes (GMOs) vir die omgewing en menslike voortbestaan inhou. Die kommersialisering van biotegnologie het gelei tot die eksponensiële groei van geneties gemanipuleerde gewasse in veral die Verenigde State en state soos Argentinië en Kanada. Hierdie state produseer groot hoeveelhede stapelgrane soos mielies en soja en poog om dit te verkoop aan state met voedselvoorsieningsprobleme. Die botsing in kommersiële belange wat spruit uit ontwikkelde state se aandrang op die beskerming van intellektuele eiendomsreg op geneties gemanipuleerde saad veroorsaak beduidende konflik met arm landbouers wie nie hulle lewensonderhoud kan verseker as hulle nie saad kan berg vir toekomstige saaiseisoene nie. Dit is een aspek van die problematiek rondom die beskerming van kennisprodukte wat vererger word deur die wetenskaplike onsekerheid wat gepaard gaan met die risiko's van biotegnologie. Terwyl sekere waarnemers vir waaksaamheid pleit in die gebruik van GMOs, is daar ander wat voel dat 'n gebrek aan wetenskaplike bewyse van skade genoegsame gronde is vir die voortsetting van ontwikkelings in biotegnologie. Insgelyks is daar diegene wat meen dat biotegnologie markgedrewe in plaas van menslike behoefte gedrewe is, wat uiteindelik daartoe lei dat ontwikkelende state baie min voordeel daaruit trek. Die Kartagena Protokoloor bioveiligheid is opgestel om van die probleme betrokke by die oorgrens verskuiwing van GMOs aan te spreek. Hoewel dit spesifieke voordele vir ontikkelende state inhou is dit as reguleringsraamwerk beperk in omvang en aanwending. Ontwikkelende state het beperkte beleidsopsies om hulle behoefte om biodiversiteit te beskerm en voedselvoorsiening te verseker, aan te spreek. Dit beteken dat beduidende uitdagings en beperkings hierdie state in die benutting van globale regering van openbare goedere vir die bou van menslike en tegnologiese kapasiteite in die gesig staar.

This study provides a critical and comparative analysis of biosafety regulation in South Africa and Uganda. The overall objective of the study is to establish which country prescribes a more adequate regulatory regime. Biosafety regulation under international and regional law is the first key aspect that this paper examines. This is done in order to set out a context under which domestic biosafety regulation is examined. This study argues that international law generally sets minimum standards while regional law sets higher standards for biosafety regulation. The second key area examined is biosafety regulation in South Africa. The paper sets out an overview of the relevant biosafety laws in South Africa and conducts a critical analysis of these laws pointing out their strengths and weaknesses. The study is premised on the argument that South African regulatory regime is inadequate for purposes of regulating biosafety. The third part of this paper focuses on Uganda's regulatory regime. A similar analysis was carried where the study found that the Ugandan regime is reasonably adequate for purposes of protection of the environment and human health. The final key aspect of this paper is a comparative analysis of biosafety regulation in South Africa and Uganda. This is done thematically, setting out differences and similarities. This part examines the extent to which South Africa and Uganda have attempted to comply with their international obligations. This paper concludes that, although the Ugandan regulatory regime (both existing and proposed) has some weaknesses, it is a more adequate regime than the South African one. Further, Uganda is more compliant with the biosafety Protocol and the African Model Law than South Africa.

This thesis explores the perspectives and related behavioural shifts of the heterogeneous Kenyan scientific community in the development and subsequent implementation of biosafety regulations. Kenya's biotechnology innovation system has been driven largely by the contradictory framing of biotechnology as a scientific tool for innovation and international competitiveness on the one hand, and as a technology that has adverse effects on the environment on the other. A transition towards an integrated regulatory system over the last one and half decades had entailed unprecedented institutional configurations and changes in behavioural patterns of the scientific community. To analyse the role of the scientific community in shaping the regulatory process and instruments in the evolving biotechnology innovation system, the thesis draws on interviews, documentary analysis and observation data collected from a wide range of scientist and non scientist actors. It finds that, as scientists adapt to institutional changes necessitated by the biotechnology innovation transition, they have been reconstituting themselves consciously and unconsciously around different linear and non linear modes of knowledge production. In the process, learning has occurred, knowledge has been produced and diffused impacting on both technological innovation and emergence of a regulatory regime. The latter is however bounded up in the former. The thesis further finds that the capacity to influence the regulatory process and instruments was spurred not only by the individualised scientific expertise, but also by the relationships and coalitions built around the different regulatory phases. Knowledge produced in this regulatory context challenges the application of knowledge theories in the light of its potential to influence scientific practice and regulatory policy instruments. From lessons and insights drawn from theories of knowledge, the emerging policies and practices are skewed towards a narrow, linear form of technical and scientific expertise, thus ignoring many underpinning factors that are important for emergence of socially desirable processes and policies. The study recommends reconceptualisation of both scientific practice and policymaking in reflexive and systemic ways that encourage incremental learning.

There is a growing importance for both biosecurity and biosafety globally and locally. In this context, this study examined and compared the biosecurity and biosafety systems of the Philippines and New Zealand. This study also considered the central issue of whether the international idea that biosecurity should be the strategic and integrated approach covering and encompassing biosafety and other related instruments, is present or being practised in the national context. This study utilised a qualitative research framework. It followed a case study approach as a process and a product of analysis, and employed triangulation technique of in-depth interviews, observation and used of pertinent/documents in gathering the relevant data and information. This study found that there are complexity of systems, policies, legislation, regulations, and cross-cutting issues that surround biosecurity and biosafety in the Philippines and New Zealand. In terms of biosecurity encompassing biosafety in the local context, this study revealed that such a concept is not yet present in the Philippines, whilst, to some extent it is happening in New Zealand. This study concluded that unless steps are taken to make national policies better informed, enhance understanding of the nature and relevance of biosecurity, and set strategic and operational priorities, then there will be a continuing overlap between biosecurity and biosafety at the national or local level.

This thesis analyses existing and new impetus for cross-national regulatory systems for modern biotechnology sparked in southern Africa by the 2002/03 food aid crisis. The study examined the roles the African Union (AU), the New Partnership for Africa's Development (NEPAD) and the Southern African Development Community (SADC), who, together with other regional and international bodies have initiated processes to assist the 14-country SADC region towards cross-national similarity or convergence of biosafety systems. This case study research was guided by the three factor conceptualisation of Per Olof Busch and Helge Jorgens (2005), which proposes harmonisation, diffusion and coercive imposition as three distinct international mechanisms causing policy change and policy convergence. Theoretical perspectives, data gathering and analysis approaches adopted an interdisciplinary and holistic approach in navigating the complex technological, regulatory and socio-political settings. Data was collected primarily using questionnaires, semistructured interviews and document review throughout the study period, and in-situ observation of processes and organisational interactions during a three-month internship at NEPAD in the middle of 2007. Different stakeholder understandings of convergence, and fluctuating motivations and fears regarding its emergence and implementation were observed. The processes towards a transnational framework were viewed as more important than the outputs thereof. Minimal, if any convergence had occurred in entire regulatory systems, or policies, while lower level targets such as policy scopes, objectives, institutional arrangements and regulations had converged to varying extents. The three SNOs had played different roles in this, singly or collectively, particularly via ideational and epistemic influence exerted through interplay between the three mechanisms proposed by Busch and Jorgens (2005), with diffusion of practices being most prominent. Therefore, and as observed by other researchers, the three mechanisms were not mutually exclusive, and their effect on spread of policies depended a lot on contextual factors within organisations, sectors, countries and the region. The thesis introduces the notion of layered convergence as one feasible outcome of the cross-national processes.

Dans ce travail de thèse de doctorat, des études expérimentales et théoriques sont réalisées sur les caractéristiques de décomposition du mélange gazeux C5F10O/N2/O2 à l'interface gaz-solide de matériaux métalliques et sous l'action d'une décharge électrique dans un appareil de coupure électrique. La faisabilité et la sécurité de son utilisation sont évaluées en combinaison avec la biosécurité du gaz C5F10O et des produits de décomposition du gaz plasmagène. Compte tenu du contact long entre le mélange gazeux C5F10O/N2/O2 et les matériaux internes de l'équipement de coupure électrique pendant son fonctionnement, la stabilité de l'interaction gaz-solide du mélange gazeux avec les métaux couramment utilisés (cuivre, aluminium et argent), à l'intérieur de l'équipement est caractérisé, et le mécanisme d'interaction gaz-solide entre le mélange gazeux C5F10O et les matériaux métalliques est précisé. Un défaut thermique peut également se produire pendant le fonctionnement de l'équipement. Les caractéristiques typiques de la décharge et de la décomposition par défaut thermique du mélange gazeux C5F10O/N2/O2 contenant différentes concentrations d'oxygène sont identifiées. La composition et les processus de création des produits de décomposition du mélange gazeux sont obtenues, et la corrélation entre les types et le contenu des produits de décomposition caractéristiques et les types de défaut, ainsi que la réaction de l'oxygène vers les produits de décomposition du mélange gazeux C5F10O et le mécanisme d'inhibition de la précipitation des produits solides sont analysés. Sur la base de ce travail, nous proposons un schéma d'optimisation de la stabilité de la couche protectrice argent- cuivre est proposé pour le cuivre avec une faible stabilité gaz-solide du gaz C5F10O/N2/O2. Nous avons défini les produits caractéristiques de la décharge et du défaut thermique du mélange gazeux, ce qui constitue une référence pour la surveillance en ligne des défauts. Nous avons testé la biosécurité du C5F10O et des produits de décomposition par arc. Sa sécurité d'application a été évaluée en fonction des caractéristiques de décharge et de décomposition thermique du mélange gazeux, et des mesures et de protection ciblées et des suggestions sont proposées
In this doctoral thesis work, experimental and theoretical studies are carried out on the decomposition characteristics of C5F10O/N2/O2 gas mixture at the gas-solid interface of metal materials and under the discharge and thermal action, and the feasibility and safety of its application are evaluated in combination with the biosafety of C5F10O gas and arc decomposition products of C5F10O/N2/O2. Considering the long-term contact between C5F10O/N2/O2 gas mixture and the internal materials of the equipment during normal operation, the gas-solid interaction stability of C5F10O/N2/O2 gas mixture with commonly used metal copper, aluminum and silver inside the equipment is evaluated, and the mechanism of gas-solid interface interaction between C5F10O gas mixture and metal materials is clarified. Discharge and thermal fault may also occur during the long-term operation of the equipment. The failure decomposition mechanism of C5F10O/N2/O2 gas mixture is studied through experiments and simulations. The typical discharge and thermal fault decomposition characteristics of C5F10O/N2/O2 gas mixture containing different concentrations of oxygen are revealed. The composition and generation rules of decomposition products of the gas mixture under the faults are obtained, and the correlation between the types and contents of characteristic decomposition products and the fault types, as well as the regulation of oxygen to C5F10O gas mixture decomposition products and the inhibition mechanism of solid product precipitation are analyzed. In conclusion, based on the simulation and experimental results, we proposed the stability optimization scheme of silver-plated protective layer on copper surface for metal copper material with poor gas-solid stability of C5F10O/N2/O2 gas. We extracted the characteristic products characterizing the discharge and thermal fault of C5F10O/N2/O2 gas mixture, which provided a reference for the on-line fault monitoring based on the decomposition components. We tested the biosafety of C5F10O and its arc decomposition products, and evaluated its application safety based on the discharge and thermal fault decomposition characteristics of C5F10O/N2/O2 gas mixture, and proposed targeted safety protection measures and suggestions

El productes de plasma dessecat per esprai (SDP) tenen un alt contingut proteic i són components útils per a moltes aplicacions, principalment com a productes valuosos per la nutrició animal. El plasma s'obté a partir de sang de porcs sans aptes pel consum humà. Durant l’obtenció, s’afegeixen anticoagulants i la sang s’emmagatzema en tancs refrigerats. Un cop a la planta de processament, la sang es centrifuga, per separar el plasma de la fracció cel∙lular. El plasma es deshidrata en un procés d'assecat per polvorització per produir un producte final en pols. El dispositiu assecador crea microgotes per aspersió del plasma a alta pressió, l’aigua s'evapora per l'entrada d'aire a 170‐250°C i una temperatura de sortida a 80°C. L'assecat per esprai o polvorització produeix diferents efectes simultanis de deshidratació, canvis de temperatura i altres efectes com canvis osmòtics, dany oxidatiu i desnaturalització proteica que podrien contribuir a explicar un procés encara poc entès d'inactivació microbiana. L'objectiu d'aquesta tesi va ser avaluar si el plasma porcí assecat per aerosol (SDPP), en forma de producte comercial i obtingut a partir de lots de milers de porcs y sotmès a tractament, podria transmetre o no alguns dels virus més resistents a altes temperatures y que per altra banda, de forma molt freqüent, afecten a la producció porcina. Atès que la majoria d'elles poden produir infeccions inaparents, fins i tot a l’edat de final d’engreix, el risc que es puguin trobar a a la sang de recollida d’escorxador no és menyspreable. En el primer estudi es va fer el seguiment de la transmissió del Parvovirus porcí (PPV) durant el subministra d’SDPP comercial, com a model de detecció de virus d'alta resistència tèrmica, en porcs susceptibles. Trenta‐sis porcs Landrace x Duroc deslletats (28 d d'edat) van ser alimentats amb dietes que contenien 0 o 8% SDPP. El lot d’SDPP utilitzat contenia anticossos (ABs) per PPV (títol 1: 400). Es varen prendre mostres de sang dels porcs els dies 0 i 63 per a determinar si l'alimentació SDPP havia causat el desenvolupament d'ABs contra PPV, Virus de la síndrome reproductiva i respiratòria (PRRSV) o el Virus de la malaltia d'Aujeszky (ADV). La inclusió de SDPP a la dieta va millorar el creixement dels porcs sense seroconversió contra els virus estudiats. L'objectiu del segon estudi fou avaluar si l’SDPP comercial que conté genoma del Circovirus porcí tipus 2 (PCV2) podia ser un vehicle de transmissió d'aquest virus. Es varen utilitzar garrins Landrace recent deslletats de truges no virèmiques i seleccionats per baixos títols d'ABs. En aquest estudi, l'absència d'ABs enfront PCV2 en porcs experimentals no era necessari ja que els anticossos materns són comuns a les granges comercials. L’SDPP es va incloure en les dietes d'assaig a 0 o 8%. El lot SDPP utilitzat a l'estudi contenia 2,47 x 105 còpies d'ADN de PCV2 / ml mesurats per PCR quantitativa en temps real (qrt‐PCR). Els porcs van ser mostrejats a dies 0, 10, 35 i 45 . No es va observar virèmia o seroconversió enfront PCV2 en porcs alimentats amb SDPP i tampoc no es va observar seroconversió a cap altre dels virus analitzats (PPV, el virus de la malaltia vesicular porcina i ADV). En el tercer estudi, l’SDPP que contenia ADN de PCV2 es va utilitzar per provar la potencial transmissió del PCV2 de porcs inoculats amb el PRRSV. El PRRSV és un virus amb efectes immunomoduladors que normalment facilita les infeccions concurrents. Vint‐i‐tres porcs Landrace de 3,5 setmanes d'edat distribuïts en un arranjament factorial 2 x 2 i assignats a corralines de nivell de bioseguretat 3 (BSL3) per evitar la contaminació creuada per PRRSV (ja que és un virus molt estès en la producció comercial). Les dietes contenien 0 o 8% SDPP. El lot comercial específic de SDPP utilitzat en aquest estudi contenia 7,56 x 105 còpies del genoma de PCV2 per gram. Els porcs varen ser mostrejats a 0, 14 i 28 dies després de l'exposició PRRSV. Tant els grups desafiats amb PRRSV com amb SDPP no varen donar lloc a la transmissió de PCV2. El quart estudi es va dirigir a avaluar si l’SDPP comercial podia estar involucrat en la transmissió del Virus de l'hepatitis E (VHE), una infecció viral freqüent entre la població de porcs i que ha estat reconegut com a zoonotic potencial. Es van trobar ABs enfront HEV en el 100% de les 84 mostres analitzades de diferents lots comercials d’SDPP d'origen espanyol, mentre que només el 22,4% de les mateixes mostres varen ser positives a l'ARN del VHE. En conseqüència, era un motiu de preocupació saber si SDPP pot contribuir a la transmissió del VHE per SDPP. Es varen analitzar mostres de sèrum d'estudis previs en els quals s'havien alimentat els porcs amb dietes comercials SDPP al 0 o 8% per detectar HEV. L’edat dels porcs va variar de 3 a 15 setmanes d’edat i la durada d'alimentació va ser entre 4 a 9 setmanes, depenent de l'experiment. En una de les mostres d’SDPP es va confirmar que contenia VHE ARN. No es va detectar seroconversió en cap dels animals pertanyents als diferents estudis, el que va portar a la conclusió que l’SDPP no representa un risc per a la transmissió del VHE. Es pot concloure que els resultats dels estudis abans esmentats van contribuir a aclarir que SDPP no sembla ser un vector de patògens i, per tant, és un ingredient d’alt contingut de proteïna natural segur i d'alta qualitat per al seu ús en l'alimentació animal.
El plasma desecado por aerosol (SDP) tiene un alto contenido proteico, que lo convierte en un componente útil para muchas aplicaciones, y de alto valor para la nutrición animal. El plasma se obtiene a partir de sangre de cerdos sanos, aptos para el consumo humano. Durante su obtención, se añaden anticoagulantes y la sangre se almacena en tanques refrigerados. Una vez en la planta de procesado, la sangre se centrifuga, para separar el plasma de la fracción celular. El plasma se deshidrata mediante un proceso de secado por pulverización en aerosol para producir un producto final en polvo. El dispositivo crea un espray de microgotas por aspersión del plasma a alta presión, el agua se evapora por la entrada de aire a 170‐250°C y una temperatura de salida de 80°C. El secado por pulverización produce distintos efectos simultáneos, incluyendo: deshidratación, cambios bruscos de temperatura y otros efectos tales como cambios osmóticos, estrés oxidativo y desnaturalitzación proteica que podrían contribuir a explicar un proceso aún poco entendido de inactivación microbiana. El objetivo de esta tesis fue el de evaluar si el plasma porcino desecado por aerosol (SDPP) en forma de producto comercial y obtenido a partir de lotes de miles de cerdos podría transmitir o no algunos de los virus más resistentes a altas temperaturas y que frecuentemente afectan a la producción porcina. Dado que la mayoría de ellos pueden producir infecciones inaparentes, incluso a la edad de final de engorde, el riesgo que puedan encontrarse en la sangre recogida en matadero no es despreciable. En el primer estudio se realizó un seguimiento de transmisión del Parvovirus porcino (PPV) durante el aporte de SDPP comercial en la dieta, como un modelo de detección de virus de alta resistencia térmica, en cerdos susceptibles. Treinta y seis cerdos Landrace x Duroc recién destetados (28 de edad) se alimentaron con dietas que contenían 0 o 8% SDPP. El lote de SDPP utilizado contenía anticuerpos (ABs) para PPV (título 1: 400). Se tomaron muestras de sangre de cerdos en el día 0 y 63 para determinar si la inclusión de SDPP en el alimento había causado el desarrollo de ABs frente PPV, el Virus del síndrome reproductivo y respiratorio porcino (PRRSV) o el Virus de la enfermedad de Aujeszky (ADV). La inclusión de SDPP en la dieta mejoró el crecimiento de los cerdos sin seroconversión frente a los virus estudiados. El objetivo del segundo estudio consistió en evaluar si el SDPP comercial que contenía genoma de Circovirus porcino tipo 2 (PCV2) podía ser un vehículo de transmisión de este virus. Se utilizaron lechones Landrace recién destetados de cerdas no virémicas y seleccionados por presentar bajos títulos de ABs. En este estudio, la ausencia de ABs frente PCV2 en cerdos experimentales no era una condición excluyente, ya que los anticuerpos maternos son un factor común en los cerdos de granjas comerciales. El SDPP se incluyó en las dietas de ensayo a 0 o 8%. El lote de SDPP utilizado en el estudio contenía 2,47 x 105 copias de ADN de PCV2 / ml medidos por PCR cuantitativa de tiempo real PCR (qrtPCR). Los cerdos fueron muestreados a 0, 10, 35 y 45 días. No se observó viremia o seroconversión frente PCV2 en los cerdos alimentados con SDPP y tampoco se observó seroconversión frente a ninguno de los otros virus analizados (PPV, el virus de la enfermedad vesicular porcina, y ADV). En el tercer estudio, el SDPP que contenía ADN de PCV2 se utilizó para probar la potencial transmisión del PCV2 en cerdos inoculados con el PRRSV. El PRRSV es un virus con efectos inmunomoduladores que normalmente facilita las infecciones concurrentes. Veintitrés cerdos Landrace de 3,5 semanas de edad fueron distribuidos en un diseño factorial 2 x 2 y asignados a corralinas BSL3 para evitar la contaminación cruzada por PRRSV (un virus ampliamente extendido en condiciones de producción comercial). Las dietas contenían 0 o 8% SDPP. El lote comercial específico de SDPP utilizado en este estudio contenía 7,56 x 105 copias del genoma de PCV2 por gramo. Los cerdos se muestrearon a 0, 14 i 28 d después de la exposición al PRRSV. Los grupos desafiados con PRRSV y alimentados con SDPP no dieron lugar a transmisión del PCV2. El cuarto estudio se dirigió a evaluar si el SDPP comercial estaba involucrado en la transmisión del Virus de la Hepatitis E (VHE), una infección viral frecuente entre la población de cerdos que ha sido reconocido como un virus con potencial zoonótico. Se encontraron ABs frente a HEV en el 100% de las 84 muestras analizadas de distintos lotes comerciales de SDPP de origen español, mientras que solo el 22,4% de las mismas muestras fueron positivas por ARN del VHE. En consecuencia, era un motivo de preocupación conocer si el SDPP puede contribuir a la transmisión del el VHE. Se analizaron muestras de estudios previos en los que se habían alimentado los cerdos con dietas comerciales con SDPP al 0 o 8% para detectar HEV. La edad de los cerdos varió entre 3 a 15 semanas de edad y la duración de la alimentación fue entre 4 a 9 semanas, dependiendo del experimento. Una de las muestras de SDPP se confirmó que contenía ARN del VHE. No se detectó la seroconversión en ninguno de los animales pertenecientes a los distintos estudios, lo que condujo a la conclusión que el SDPP no representa un riesgo para la transmisión del VHE. Se concluyó que los resultados de los estudios mencionados contribuyeron a aclarar que el SDPP no parece ser un vector de los agentes patógenos estudiados y, por lo tanto, según los estudios realizados se trata de un ingrediente natural seguro de alta calidad con un alto contenido de proteínas para su uso en nutrición animal.
Spray dried plasma (SDP) products have high protein contents and, therefore, are useful components for many applications, mainly as valuable products for animal nutrition. Plasma is obtained from blood of healthy pigs fit for slaughter for human consumption. Blood is pooled from many animals, collected in tanks with anticoagulant and chilled. In the processing plant, blood is centrifuged to separate the plasma from cellular fraction and dehydrated by a spray‐drying process to produce a powered ingredient. The spray dryer device creates micro‐drops and evaporates water by inlet air at 170‐250°C and outlet temperature at 80°C. Spray‐drying produces concurrent effects of dehydration, changes of temperature and others effects such as osmotic changes, oxidative damage, and protein denaturizing stress that could contribute to explain a poorly understood process of microbial inactivation. The objective of this thesis was to evaluate if commercial spray dried porcine plasma (SDPP) obtained from batches of thousands of pigs could transmit or not some of most common high heat resistant viruses that affect swine production. Since most of them may produce unapparent infections at slaughter age, the risk to be found in collected blood at slaughterhouse is not negligible. In the first study, Porcine parvovirus (PPV) transmission throughout commercial SDPP, as model of high thermally resistant virus, was explored in susceptible naïve pigs. Thirty‐six Landrace × Duroc weanling pigs (28 d of age) were fed with diets containing either 0 or 8% SDPP. The SDPP lot used contained antibodies (ABs) to PPV (titer 1:400). Blood samples were collected from pigs on d0 and 63 to determine whether feeding SDPP caused development of ABs against PPV, Porcine reproductive and respiratory syndrome virus (PRRSV) or Aujezsky disease virus (ADV). Inclusion of SDPP in the diet improved growth of pigs without seroconversion against studied viruses. The objective of the second study was to assess if commercial SDPP containing Porcine circovirus type 2 (PCV2) genome may be a vehicle of transmission for this virus. Weaned Landrace piglets from non viremic sows and selected for low ABs titres were used. In this study, absence of ABs against PCV2 in experimental pigs was not required because maternal antibodies are widespread in commercial farms. SDPP were included in the test diets at 0 or 8%. The SDPP lot used in the study contained 2.47 x 105 PCV2 DNA copies/ml measured by quantitative real time PCR (qPCR). Pigs were sampled at 0, 10, 35 and 45 d. No viremia or seroconversion against PCV2 was observed in pigs fed with SDPP and also no seroconversion to other virus analyzed (PPV, ADV and Swine vesicular disease virus, SVDV) was observed. In the third study, SDPP containing PCV2 DNA was used to test the potential transmission of PCV2 to pigs challenged with PRRSV. PRRSV is a virus with immunomodulatory effects that usually facilitates concurrent infections. Twenty‐three Landrace pigs of 3.5 weeks (w) of age were distributed in a 2 x 2 factorial arrangement and allocated in BSL3 boxes to avoid PRRSV cross‐contamination (since it is a widely spread virus under commercial production conditions). The diets contained 0 or 8% SDPP. The specific commercial lot of SDPP used in this study contained 7.56 x 105 PCV2 genome copies per gram. Pigs were sampled at 0, 14 and 28 d post PRRSV challenge. PRRSV challenged groups and SDPP groups, did not result in PCV2 transmission. The fourth study was addressed to assess if commercial SDPP was involved in the transmission of Hepatitis E virus (HEV), a prevalent viral infection within the pig population that has been recognized with zoonotic potential. HEV ABs were found in 100% of 84 samples of different commercial SDPP lots from Spanish origin, while only 22.4% of the same samples were positive for HEV RNA. Accordingly, it was of concern to know if SDPP may contribute to HEV transmission by SDPP. Serum samples from previous studies in which naïve pigs were fed with commercial SDPP diets at 0 or 8% were analysed to detect HEV. Age of pigs ranged from 3 to 15w of age and the feeding duration was between 4 to 9w, depending on the experiment. One of the lots of SDPP was confirmed to contain HEV RNA. HEV seroconversion was not detected in any of the animals belonging to the different studies, leading to the conclusion that SDPP does not represent a risk for HEV transmission. It can be concluded that the results of the above mentioned studies contributed to clarify that SDPP seems not to be a vector for pathogens and, therefore, it is a natural, safe, high‐quality ingredient with high protein contents for use in animal nutrition.

Introdução: Moldes, modelos e próteses são veículos de microrganismos entre o consultório odontológico e o laboratório de prótese dentária, portanto, a adoção de medidas de biossegurança por cirurgiões dentistas e técnicos de prótese dentária são essenciais para a manutenção de uma cadeia asséptica. Objetivo: Este estudo verificou o comportamento de cirurgiões dentistas durante o manuseio de moldes, modelos e trabalhos protéticos na cidade de Porto Velho, RO. Método: Foram incluídos no estudo cirurgiões dentistas inscritos no Conselho Regional de Odontologia da cidade de Porto de Velho. Um questionário contendo perguntas relacionadas às condutas de biossegurança que envolvem trabalhos protéticos foi aplicado aos participantes do estudo. A análise estatística foi conduzida adotando nível de significância estatística de 95% (p<0,05), com auxílio do software Bio Estat 5.0. Resultados: 71 cirurgiões dentistas (CD) participaram do estudo, com média de idade de 3410 anos. Todos sempre utilizavam avental, luvas e máscara durante o atendimento ao paciente, 59,15% dos profissionais afirmaram sempre realizar a desinfecção do molde após sua confecção, sendo que o alginato (88,73%) e a silicona (66,20%) foram os materiais de escolha para moldagem Quanto à desinfecção do modelo quando recebido do laboratório de prótese 43,66% afirmaram nunca realizar o procedimento, 40,75% utilizam o glutaraldeido 2% para realizar a desinfecção e 35,21% dos profissionais utilizam a imersão como método de desinfecção. Quanto ao tempo de exposição ao desinfetante, 21,13% expõem o artigo por dez minutos, 19,72% por um minuto e 19,72% por trinta minutos e 85,94% dos profissionais submetem as moldeiras ao processo de esterilização. Conclusão: A aplicação das normas de biossegurança em trabalhos protéticos, pelos profissionais da cidade de Porto Velho (RO), está aquém do esperado para que haja redução no risco de infecção cruzada.
Introduction: Patterns, models and prostheses are vehicles of microorganisms between the dental office and dental laboratory, therefore, the adoption of biosecurity measures by dentists and dental technicians are essential to maintaining an aseptic chain. Objective: This study investigated the behavior of dentists during the handling of templates, models and prosthetic works in the city of Porto Velho, RO. Method: The study included dentists enrolled in the Regional Council of Dentistry of Porto Velho. A questionnaire concerning the conduct of biosafety studies involving prosthetic was applied to study participants. Statistical analysis was conducted by adopting statistical significance level of 95% (p <0.05), using the software Bio Estat 5.0. Results: 71 dentists (CD) were enrolled, mean age 34 10 years. Everyone always used aprons, gloves and mask during patient care, 59.15% of the respondents said they always carry out disinfection of the mold after its making, and the alginate (88.73%) and silicon (66.20%) were the material of choice for casting The disinfection of the model when received from the dental lab 43.66% say they never perform the procedure, 40.75% are using 2% glutaraldehyde for disinfection and hold 35.21% of professionals use the immersion as a method of disinfection. Regarding the duration of exposure to disinfectant, the article exposes 21.13% for ten minutes, 19.72% for one minute and 19.72% for thirty minutes and 85.94% of the professionals submit the trays to the sterilization process. Conclusion: The implementation of biosafety norms in prosthetic works by professionals in the city of Porto Velho (RO), is less than expected so there is reduced risk of cross infection.

This dissertation investigates the social controversy and regulatory challenges presented by genetically engineered (GE) crops in India. Current research insufficiently addresses risk controversies in the developing world, nor provides adequate consideration of GE biosafety as an important socio-political concept as well as a technical one. The study addresses these gaps by mapping the GE controversy in India, its insertion into health and safety decision-making, and the ways in which divergent stakeholders have established positions in these risk debates. Secondly, it assesses the challenges facing the biosafety regulatory regime in India, particularly as a country undergoing a "risk transition," whereby a growing middle class and marginal farmers are pitted against one another in surprising ways. The data for this study are drawn from three main sources using a case study methodology. Firstly, interviews with: farmers, civil society groups, and regulators. Secondly, an analysis of key policy and legal documents that serve as the foundation of India's regulatory regime. And finally, an analysis of the literature and materials that help make up the "public debate" including NGO publications, website postings, films, and newspaper articles covering aspects of the controversy from key Indian English language sources. Rooted in the social studies of risk, the dissertation also draws from literatures on comparative policy analysis, narrative theory in social science, political ecology, and science and technology studies. India is undergoing a "risk transition", and the country's response to GE agriculture can be expected to differ from what has been more thoroughly mapped in other parts of the world. Moreover, biosafety is the central organizing principle of agricultural biotechnology regulation in India, and its ongoing negotiated quality has spurred both regulatory innovation and larger governance challenges. India has a diverse, largely agrarian population and this study finds that developing new ways to understand how the GE regulatory regime is changed by public debate is crucial, as are meaningful ways to solicit and incorporate public participation in a complex democracy. Strategies to address public perspectives must extend beyond organized civil society groups to include other citizens, especially marginal producers with much at stake in the GE debates.

Vigorous debates have taken place in many European countries, and between the EU and the USA, about regulatory policy regimes covering the assessment and approval of GM crops. In such countries the debates have, to a large extent, taken place in public arenas and with the active participation of broadcast and print media. In Iran, a very vigorous and hotly-contested policy debate concerning legislation covering GM crops took place between 2004 and 2009, but it was almost entirely confined within the Government with no public debate and minimal media coverage. From early 2006 to late 2008 a protracted dispute occurred between different parts of the Iranian regime, which was characterised by an apparent stalemate. In 2008-2009, conspicuous policy shifts occurred, which culminated in the passage of a Biosafety Law by the Iranian Parliament (or Majlis). This thesis describes, analyses and explains the policy-making process from 2006 to 2009. It explains firstly how and why a stalemate arose in the disputes between ministries and departments. It then explains how that impasse was overcome, and how a particular policy regime came to be adopted. The chosen analytical framework draws mainly on two bodies of literature, namely the regulation of technological risk, and the analysis of public policymaking. A task-specific analytical framework is developed which uses the concept of the ‘framing assumptions', which underpin the particular positions taken by the diverse protagonists in the debate, to analyse the characteristics of the seemingly irresolvable dispute. The differences between those framing assumptions are used to provide an explanation of why the stalemate arose and remained unresolved for several years. The explanation of the eventual policy outcome takes account of those framing assumptions, but on their own they are not sufficient to explain the eventual policy decisions. To provide that explanation, considerations of the unequal division of political power between parts of the Iranian regime are required. The Iranian case study, despite some of its unique characteristics, can support several general conclusions about the dynamics of risk policy making, the conditions under which disputes can arise and those under which they may be resolved.

This study makes a comparative analysis of the current biosafety legislation in South Africa and the interim biosafety regulatory regime in Uganda. A set of common characteristics and components in biosafety regulatory systems with reference to related provisions of the Cartagena Protocol on Biosafety were used. The introduction of genetically modified organisms (GMOs) especially in agriculture has produced a new range of governance challenges in the fields of environmental safety and human health. The regulation of modern biotechnology in Africa is still in its infancy. Despite this, legislation is urgently required to regulate modern biotechnology. The study assessed how the Cartagena Protocol on Biosafety is implemented by South Africa and Uganda. The study revealed that though the Cartagena Protocol has gone some way in regulating modern biotechnology, its implementation in countries such as South Africa and Uganda has not resulted in the harmonization of the domestic regulatory process. On the national level, the study noted that the biosafety legislation of South Africa and the interim biosafety regulatory regime of Uganda do not fully comply with the provisions of the Cartagena Protocol. This is mainly because each country has taken a different approach in implementing the protocol depending on its domestic priorities, imperatives and position in the global agricultural market. Finally, the study made recommendations on possible ways in which South Africa and Uganda can coordinate and harmonize their national biosafety regulatory systems. These will enable the two biosafety regulatory systems to become more compliant with the provisions of the protocol.

O objetivo deste trabalho foi avaliar qualitativamente a contaminação microbiana de dispositivos auriculares do arco facial, articuladores semi-ajustáveis e in vivo os condutos auditivos externos antes e após anti-sepsia com clorexidina 0,2% de pacientes da Clínica de Odontologia da FORP-USP. Foi realizado um plano piloto com 20 articuladores (ramo superior e ramo inferior) e 20 dispositivos auriculares (direito e esquerdo) da clínica de graduação da FORP-USP em dois tempos, início do ano letivo e final do ano letivo. Para os articuladores um swab embebido em salina era esfregado numa área de 4,0 cm² delimitada por template; para o dispositivo auricular o swab era esfregado ao redor deste e então colocados em tubos de ensaio contendo 1,0 ml de salina. Após agitar os tubos, a suspensão era semeada em Agar Tioglicolato e o restante da salina enriquecido com caldo Tioglicolato e incubado a temperatura ambiente por no mínimo três dias para verificação do crescimento microbiano. Foram avaliados também 20 articuladores após desinfecção previa da área delimitada com álcool 70% esfregada com gaze esterilizada por três vezes. Vinte arco faciais (40 dispositivos - direito e esquerdo) fornecidos pela BioArt (São Carlos - SP) foram avaliados após esterilização e uso em paciente. O dispositivo esterilizado era encaixado com auxílio do próprio papel da embalagem de esterilização e colocado no conduto auditivo externo pelo paciente por dois minutos. A seguir o dispositivo era removido com mão enluvada e colocado em tubo de ensaio contendo 1,0 ml de salina. O restante do material e método foi igual ao plano piloto. Foi avaliada a contaminação microbiana de condutos auditivos externos de 20 pacientes; antes da anti-sepsia um swab umedecido em salina era esfregado pelo paciente e após anti-sepsia, um cotonete embebido em clorexidina 0,2% era esfregado por 30 segundos pelo paciente no conduto auditivo externo e a colheita do material era feita após com um swab embebido em salina. O restante do material e método foi igual aos demais grupos. Foi feita a coloração de Gram para identificação dos morfotipos e os cocos gram-positivos (Staphylococcus) semeados em Kit Api Staph (BioMerieux) e os bacilos gram-positivos esporulados e bacilos gram-negativos em serie de Hiss convencional (em tubos). Os cocos foram identificados como: Staphylococcus epidermidis, Staphylococcus saprophyticus, Staphylococcus roseus, Staphylococcus asaccharolyticus, Staphylococcus minimus, e ainda Kokuria ryzophyla; os bacilos gram-positivos aerobios esporulados como: Bacillus atropheus, Bacillus acnes, Bacillus alvei e o único bacilo gram-negativo como: Alcaligenes faecalis. Baseado nos resultados verificou-se que todos os ramos superiores e inferiores dos articuladores testados e dispositivos auriculares (direito e esquerdo) do arco facial do plano piloto estavam contaminados não havendo diferença estatisticamente significante entre os dois tempos; após desinfecção com álcool 70% dos 20 articuladores testados apenas 4 estavam contaminados (media de UFC foi 7); todos os dispositivos auriculares esterilizados avaliados após uso em paciente estavam contaminados; não houve diferença estatisticamente significante na contaminação microbiana entre os condutos auditivos externos direito e esquerdo tanto antes quanto após a anti-sepsia com clorexidina 0,2%.
The purpose of this study was to evaluate the microbiological quality of the face bow earpieces, articulators and in vivo the external auditory canals before and after antisepsis with chlorexidine 0,2% of patients from the clinic of Dentistry of FORP-USP. It was done a pilot study with twenty articulators (superior and inferior branch) and twenty earpieces (right and left) from the Clinic of Dentistry of FORP-USP, twice, one in the beginning of the school year and the other in the end of the school year. For the articulators a swab moistened with saline was scratched in a 4,0 cm2 area delimited by template; for the earpieces a swab was scratched around it and then placed in tube test with 1,0 ml saline. After agitating, the suspension was inoculated in Tioglicolate Agar (DIFCO) and incubated in ambient temperature at least three days to verify the bacterial growth. It was also evaluated the microbiological quality of twenty articulators after previous disinfection of the delimited area with alcohol 70% scratched with sterilized gauze for three times. Twenty face bows (40 earpieces - right and left) were evaluated after sterilization and used in patients. The face bow and the earpieces were provided by BioArt (Sao Carlos - SP). The earpieces were incased with the paper where they were sterilized and placed in the external auditory canal by the patient for two minutes. Then, the earpieces were transferred with gloved hand to a tube test with 1,0 ml saline. The rest of the material and methods were the same of the pilot study. It was evaluated in vivo the microbiological quality of the external auditory canals of twenty patients; before the antisepsis a swab moistened with saline was scratched by the patient and after the antisepsis, a swab moistened with chlorexidine 0,2% was scratched for 30 seconds by the patient in the external auditory canal and the material was collected after the antisepsis with a swab moistened with saline. The rest of material and methods were the same of the other groups. A Gram stain was done in order to obtain the microorganisms identification with the biochemical test by the ApiStaph System (Bio Merieux) for Staphylococcus that was identified as: Staphylococcus epidermidis, Staphylococcus saprophyticus, Staphylococcus roseus, Staphylococcus asaccharolyticus, Staphylococcus minimus, and still Kokuria ryzophyla. The spore forming aerobic Gram-positive bacilli were identified by conventional tube test as: Bacillus atropheus, Bacillus acnes, Bacillus alvei and only Gram-negative bacilli as Alcaligenes faecalis. Based on the results, it was verified that almost all of the articulators branches (superior and inferior) tested and the face bow earpieces (right and left) of pilot study were contaminated, there was not a difference statistically significant between both times; after disinfection with alcohol 70% form the only four out of the twenty tested articulators were contaminated (UFC=7); all of the sterilized earpieces evaluated after being used in patients were contaminated, there was not a difference statistically significant in the microbiological quality between the external auditory canals right and left either before or after the antisepsis with chlorexidine 0,2%.

Dissertação de Mestrado Integrado em Medicina Veterinária
A biossegurança deve ser uma das prioridades dos Estados na defesa e proteção dos seus cidadãos. Os surtos epidémicos ou a ameaça do bioterrorismo exigem de governos e instituições internacionais estratégias adequadas de combate a tais riscos. Atendendo ao facto de, presentemente em Portugal, não existir legislação sobre biossegurança laboratorial suficientemente abrangente, peça-chave nesse tipo de estratégias, a presente dissertação foi elaborada com o intuito de fundamentar o desenho e conceção de um manual de biossegurança laboratorial e de o produzir para utilização no Laboratório de Bromatologia e Defesa Biológica do Exército Português. A dissertação começa por discutir a distinção conceptual entre biossegurança e bioproteção. Procede seguidamente ao seu enquadramento na perspetiva de diferentes organizações e discute a sua importância no âmbito da saúde pública. Após a identificação dos desafios atuais em biossegurança, analisam-se as respostas que têm sido dadas aos riscos a nível mundial, europeu e português, em particular no que toca ao quadro normativo, regulamentar e das convenções entre países. No contexto português, para além da abordagem à legislação atual e à nova norma de biossegurança, também foi feita referência ao projeto UPCAST e à Rede Laboratorial Portuguesa de Biossegurança. Como parte integrante da dissertação segue-se a apresentação do manual, que incide sobre infraestruturas, equipamento laboratorial, equipamento de proteção individual, manuseamento e eliminação de resíduos, boas práticas laboratoriais, entre outros. Por fim, é feita uma discussão crítica das questões que foram sendo levantadas ao longo da fundamentação do manual, procurando contextualizá-las em relação aos propósitos da dissertação e às linhas orientadoras que estruturaram o seu desenho e conceção.
ABSTRACT - The Role of the Veterinary Professional in Laboratory Biosafety and Biosecurity: Development of a Biosafety and Biosecurity Manual to the Bromatology and Biological Defence Laboratory of the Portuguese Army - Biosecurity and biosafety should be a priority of all States in the defence and protection of their citizens. Epidemic outbreaks or the threat of bioterrorism demand from Governments and international institutions appropriate strategic measures to fight such risks. In view of the fact that, currently in Portugal, there is a lack of broader laboratory biosafety and biosecurity legislation, which is a key part of this type of strategy, this thesis was elaborated in order to provide the conceptual framework for the design and conception of a biosafety and biosecurity manual and to produce it for use at the Laboratory of Bromatology and Biological Defence of the Portuguese Army. The thesis begins by discussing the conceptual distinction between biosafety and biosecurity. It then proceeds to examine those concepts in the perspective of different organisations and considers its importance in the field of public health. Following the identification of the current challenges in biosafety and biosecurity, an analyses of the responses that have been given to these risks at a global, European and Portuguese levels is done, in particular related to the regulatory framework, norms and conventions between countries. In the Portuguese context, in addition to the approach to the current legislation and the new biosafety standard, were also considered the UPCAST project and the Portuguese Biosafety Laboratory Network. The thesis includes the presentation of the manual, which focuses on infrastructure, laboratory equipment, personal protective equipment, waste handling and disposal, good laboratory practices, among others. Finally, a critical discussion is made of the issues emerged from the discussion of the conceptual framework, seeking to contextualize them in relation to the purposes of the thesis and the guidelines that structured the design and conception of the manual.
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Orientador: João Bosco Penna
Banca: Alvaro Rizzoli
Banca: Juliana Presotto Pereira Netto
Resumo: O presente trabalho tem por objetivo analisar o importante papel desempenhado pelo Princípio da Precaução (PP) no cenário atual, ou seja, em um contexto de grandes avanços tecnológicos, notadamente no que se refere às atividades biotecnológicas, o que vem proporcionando à sociedade, ao mesmo tempo, tanto sentimentos de esperança por um futuro promissor quanto incertezas de eventuais riscos à saúde das pessoas e ao meio ambiente. Busca-se, com isso, demonstrar as preocupações éticas em torno do tema que, em razão de sua natureza, por envolver interesses ligados à vida humana e à proteção ao meio ambiente, deram impulso ao desenvolvimento dos Princípios Bioéticos. Assim, discute as interrelações existentes entre esse novo ramo do saber e o tratamento dado às questões ligadas à biotecnologia. E, em razão da relevância em torno destes fatos e as conseqüências que lhe são inerentes, entende-se como inevitáveis as influências no âmbito jurídico, destacando-se a criação de novos institutos jurídicos, que surgem enquadrados no novo ramo do Biodireito. Ressalta-se, assim, a importância do Princípio da Precaução para o melhor e adequado tratamento dos problemas envolvendo biossegurança, seja do ponto de vista bioético, seja do ponto de vista biojurídico, tendo em vista a sua inserção no ordenamento jurídico pátrio, sobretudo diante de previsão expressa trazida pela Lei n.º 11.105/05. Procuramos demonstrar como o seu surgimento se dá juntamente com a evolução do conhecimento que, em razão de seu avanço, cria maiores possibilidades de intervenção do ser humano no meio ambiente e em seu próprio organismo. Destacamos, por fim, os seus mais importantes aspectos no momento de se determinar a responsabilidade em biossegurança tendo em vista as normas atualmente previstas no âmbito da atual Lei de Biossegurança. Assim, através da análise legislativa, doutrinária e jurisprudencial...
Abstract: This essay has as objective an analysis of the significant role of the Precautionary Principle (PP) in the present scene, that's it, the stage of grand technologic leaps, notably in regard to biotech activities, which is providing, at the same time, many feelings of hope for a promising future and uncertainties and occasional health and environmental risks to the society. We seek, with that, to demonstrate the ethical concerns around a subject which, by its own nature, involves connected interests to the human and wildlife conservation that started the development of Bioethics principles. In that way, the existing inter-relations between this new branch of knowledge and its treatment in view of the questioning about biotechnology are discussed. And, given the importance around these facts and its inherent results, its influence to the legal sphere are taken as inevitable, distinguishing the creation of new legal institutes, fitted in the new branch of BioLaw. It stands out the importance of Precautionary Principle to better and adequate deal with biosafety issues, be it from the bioethics, or the BioLaw point of view, because of its national legal arrangement insertion, mainly on account of the expressed due conveyed by Law no. 11.105/05. We evince that its emergence occurs along with the development of knowledge, and because this development, more possibilities of human intervention in the environment and in its own organic structure are created. At last, we take note of the important aspects when determining biosafety responsibilities, in light of the Biosafety Law precepts at present. Thus, with legislative, doctrinal, and jurisprudential analysis, and by means of deductive-intuitive method, through a criticdialectic approach on the topic, we evidence, finally, the means by which an PP adjustment to the national reality will be made, so that it will not hinder involved interests on biotech research, to the extent that its conceptual...
Mestre

Генна інженерія – сукупність прийомів, методів і технологій, які дозволяють змінювати будову генів або вносити до організму чужорідні гени із заданими функціями. При цьому в організм переноситься лише один певний ген, а решта генотипу залишається незмінною, значить, можно наділити організм ознакою, яку неможливо перенести шляхом схрещування з близькоспорідненими видами. Завдяки цьому стало можливим створення організмів з новими, в першу чергу, корисними для людини, властивостями.

Dissertação(mestrado) - Universidade Federal do Rio Grande, Programa de Pós- Graduação em Educação em Ciências: Química da Vida e Saúde, Instituto de Educação, 2010.
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A Biossegurança pode ser definida como um conjunto de ações voltadas para a prevenção, minimização ou eliminação de riscos inerentes às atividades de pesquisa, produção, ensino, desenvolvimento, tecnologia e prestação de serviços, visando à saúde do homem, à preservação do meio ambiente e à qualidade dos resultados. A biossegurança nos laboratórios didáticos das universidades muitas vezes ocupa um lugar secundário, mas que merece um destaque e um olhar mais investigativo com o propósito de minimizar possíveis riscos à saúde e ao meio ambiente. Esta dissertação tem como objetivo analisar quantitativamente e qualitativamente o estado e as práticas de biossegurança existentes nos laboratórios de ensino e pesquisa da Universidade Federal do Rio Grande – FURG. Um questionário foi aplicado aos técnicos em educação, alunos de graduação, alunos de pósgraduação e professores. O questionário foi dividido em grupos de análise e envolveu temas como: conceitos em biossegurança, riscos químicos, físicos e biológicos, riscos ergonômicos, boas práticas de laboratório, equipamentos de proteção individual e coletiva e o manuseio, controle e descarte de resíduos químicos e biológicos. Os resultados em relação aos riscos físicos, químicos e biológicos encontrados durante esta pesquisa reafirmam a necessidade de se minimizar inconformidades encontradas nos laboratórios e de se reavaliar as práticas de biossegurança. Destaca-se o caráter interventivo desta pesquisa que pode trazer benefícios associados à elaboração de um manual educativo, com normas de biossegurança para as atividades de ensino e pesquisa nos laboratórios da FURG. Outras possibilidades incluem a criação de um programa de educação continuada em biossegurança e a indução de uma responsabilidade (ética) ambiental.
Biosafety can be defined as a group of actions aimed to minimize or eliminate risks associated to research activities, production, teaching, development, technology and services with the goal of preserve human health, environment and results quality. Biosafetyusually posses a secondary role in teaching laboratories at the universities, a situation that needs to change in order to minimize eventual risks to health and to the environment. The objective of this study was to analyze in a quantitative and qualitative way the issue of biosafety in teaching and research laboratories at the Federal University of Rio Grande – FURG. A query of biosafety issues was apply to education technicians, undergraduate and graduate students and professors. The query was divided in groups involving different topics as biosafety concepts, chemical, physical and biological risks, ergonomic risks, good laboratory practices, use of individual and collective protection equipments and the handling, control and discharge of chemical and biological residues. The obtained results related to physical, chemical and biological risks stress the need to correct several problems found in the laboratories as was well as some practices that need reevaluation. It is important to note the interventive nature of present research that should bring associated benefits such as the elaboration of an educative manual for biosafety norms to be applied in teaching and research activities at the laboratories at FURG. Other possibilities include the creation of a continued education program and to generate ethical environment responsibility.

Master of Science
Food Science Institute - Animal Sciences & Industry
Sara E. Gragg
Food preparation in institutional settings is often carried out in large quantities. Food is cooked and then cooled and stored for later service. Improper or "slow" cooling has been identified by the United States Food and Drug Administration (US FDA) as a contributing factor in foodborne illness outbreaks. This study was designed to test the efficacy of cooling technique combinations on controlling microbial growth within pre-cooked taco meat, chili con carne with beans, low sodium marinara sauce, and brown rice food products. These products were cooked to 73.8°C (165°F) and then portioned to 2 and 3-inch depths in steam table pans. Food product was allowed to cool to 60°C ± 5°C (140°F ± 5°F) before inoculation with surrogate Escherichia coli (E. coli) or Biosafety Level I (BSL I) Bacillus cereus (B. cereus). Pans were uncovered or covered with one or two layers of aluminum foil to allow or restrict air exposure and then placed in a -20°C (-4°F) commercial walk-in freezer or situated in ice water baths in a commercial walk-in refrigerator 4°C (39.2°F). Food products were sampled over a 24-hour period (0, 4, 8, 12, and 24 hour time points) for enumeration of microbial populations. Conclusions from the cooling temperature data in this study revealed uncovered pans and pans stored in the freezer at 2-inch food product depths cooled most rapidly. However, few cooling methods achieved the two-step US FDA Food Code requirement for pre-cooked taco meat, chili con carne with beans, and brown rice products and none of the cooling methods tested achieved the US FDA food code requirement for low sodium marinara sauce. Surrogate E. coli and BSL I B. cereus microbial population data revealed pre-cooked taco meat, chili con carne with beans, and brown rice products all exhibited a certain degree of overall population decline during the 24-hour cooling period. However, a small recovery of surrogate E. coli population was observed in the low sodium marinara sauce product as well as 2-inch product depths of the chili con carne with beans product. This observed growth was less than 0.50 log₁₀ CFU/g, indicating low risk for microbial proliferation from the cooling methods tested. It is possible that the surrogate E. coli and BSL I B. cereus population changes observed were not the result of cooling failure or risk, but rather due to natural variations within the food products. These results indicate all 12 cooling methods tested were low risk and therefore effective at controlling E. coli and B. cereus microbial populations within the four food products.

The levying of strict biosafety regulations for GM imports intended for food, feed and processing by importing countries is expected to have socio-economic consequences. For countries like Zimbabwe the significance of the impact of the regulations lies in the context of the role of regional agricultural trade in enhancing national food security. Accordingly, this study analyses the effects of complying with the regulatory requirements on Zimbabwe s maize grain-to-maize meal import supply chain from South Africa. The study uses a combination of quantitative and qualitative measures to determine the costs and benefits of the regulation. Focusing principally on the Zimbabwean consumers at the end of the supply chain, the price effect of the added costs of complying with the regulation are considered to represent the costs of the regulation; while the concerns of the consumers regarding GMOs based on the government s concerns as implied by the regulation, are assumed to be indicative of the benefits realised as a result of the regulation. The Total Landed Cost analysis is used to estimate price effect while the Consumer Risk and Benefit Perception analysis is used to determine the consumer perception. The study reveals that Zimbabwe s strict domestic GM policy influences the regulation of trade in commodities with GM equivalents such as maize. The regulation has resulted in a dual maize grain import channel by stipulating import requirements that differentiate between GM and non-GM maize grain imports. As the only commercial producer of GM crops in southern Africa, South Africa supplies both channels. However, in the non-GM channel South Africa competes with Zambia, who only produces non-GM crops and has managed to produce substantial surpluses in recent years. Taking this into consideration, the study conducts the cost analysis by comparing the GM and the non-GM channels and, the cost of maize sourced from South Africa and Zambia. The evidence from the study suggests that the GM grain import channel is only known to be functional during times of severe food shortages, as in line with their strict GM policy the government of Zimbabwe tends to have a primary preference for non-GM maize. Nonetheless, the GM channel is characterised by a precise and elaborate compliance process aimed at preventing the grain from being used as seed. As such, the results of the cost analysis show that despite the purchase price of GM grain being significantly lower than non- GM grain the compliance procedures in the GM maize grain-to-maize meal channel makes it the most costly channel and consequently the market price of the maize meal is comparatively high. The non-GM channel features as the customary channel with the comparison between South Africa and Zambia being highly emphasized. The most important finding is that despite the premium added on non-GM maize in the South African market, the price of the grain remains comparatively competitive. However, the relatively higher transport and logistics costs in the South African channel seem to be the major contributor of higher total landed cost of non- GM maize. In addition the study finds that while the price effect of the regulation on maize meal is unclear, the cost effects have acted as a protectionist measure for local producers who sell at government gazetted prices that are well above prices in the regional market. From these findings the study concludes that although the cost effect of the regulation has a distortionary effect on trade between South Africa and Zimbabwe, it cannot be considered in isolation of other economic factors such as transport costs as well as domestic distorted markets. Therefore the recommendation is that for the regional market to realise the potential of GM grain imports in providing affordable food imports, countries do not only have to accept GM imports but they have to address other challenges to regional trade such as high transport costs. The analysis of the risk and benefit perceptions of the Zimbabwean consumers reveals that consumers are undecided about GMOs, as they perceive both high benefits and high risks. The most perceived benefit is that GM crops increase food production and supply while the major perceived risk is the negative effect on human health and the development of allergic reactions. To this end the study concludes that the concerns of governments as outlined in the National Biotechnology Act (the primary law governing GMOs) and pronounced by the Minister of Agriculture are aligned with the concerns of the consumers. However, in contradiction, the occasional exceptional acceptance of GM grain or food in times of severe food shortages has resulted in the confusion among consumers. A further examination of the perceptions shows a limited knowledge about GM technologies. The recommendation is that perhaps increased public knowledge and awareness on GMOs may demystify GMOs thus reduce the confusion among consumers. Overall, the study finds that the costs and benefits of the regulation are indistinct, as there are other socio- political and economic factors that come into play; with the findings suggesting that the perceived benefits for the consumers roughly outweigh the cost of the regulation.
Dissertation (MSc)--University of Pretoria, 2015.
Agricultural Economics, Extension and Rural Development
MSc
Unrestricted

Les progrès en biotechno]ogie ont permis le développement d’outils pour le transfert de gène intégratif en transgénèse, bioproduction et thérapie génique. Cependant, trois challenges majeurs doivent être relevés pour garantir un système sécurisé : l’innocuité et l’efficacité du transfert, l’intégration ciblée et contrôlée dans le génome, le niveau et la durée d’expression du transgène au cours du temps. Dans ce but, mes travaux de thèse ont consisté à tester des solutions pour améliorer la biosécurité du transposon piggyBac qui nécessite un plasmide porteur du gène d’intérêt à insérer dans le génome et une source de transposase catalysant la réaction d’intégration du transgène. Une des stratégies de ma thèse repose sur l’apport de la source de transposase sous forme d’ARN messager au lieu d’ADN afin d’améliorer la stabilité de l’intégration et de réduire les effets génotoxiques en limitant la transposase dans les cellules. Pour la première fois, la biodisponibilité de l’ARNm de la transposase et les conditions optimales d’utilisation en cellules humaines ont été déterminées pour augmenter la biosêcurité du système. Le second objectif de mes travaux consiste à améliorer l’expression du transgène en ajoutant des insulateurs connus pour s’opposer à l’extinction de l’expression des gênes. En termes de biosécurité, cette stratégie permet de réduire le nombre de copies du transgène nécessaires pour obtenir une expression suffisante. Deux candidats ont été identifiés pour améliorer l’expression du transgène. La combinaison des approches ARNrn et insulateurs est prometteuse pour sécuriser le transfert de gène médié par piggyBac et pour maintenir l’expression du gène d’intérêt
Advances in biotechnology have enabled the development of tools for gene transfer applicable to transgenesis, bioproduction and gene therapy. But, 3 major challenges must be met to ensure a secure system: the safety and effectiveness of the transfer. the targeted and controlled integration into the genome. and the level of transgene expression over time. In this aim, my thesis project was to validate solutions to improve the biosafety of the piggyBac transposon, which requires a plasmid carrying the gene of interest to be inserted in the genome, and a source of transposase which catalyzes the transgene integration. One approach of my thesis work is to deliver the source of piggyBac transposase as an mRNA molecule instead of DNA. This strategy aims to improve the stability of the integration and reduce the genotoxic effects by limiting the transposase in the cells. For the 1st time, the bioavailability of the transposase rnRNA and the optimal conditions for its use in human cells were determined to increase the biosafety of the transposon system. The 2nd objective ofmy project is to improve the expression of the transgene by adding insulators known to counteract the transgene silencing. This strategy reduces the number of integrations required ta get a sufficient expression of the transgene and thus, improve biosecurity. Two candidates have been identified to improve transgene expression. The combination of the mRNA and insulator strategies is promising to secure the piggyBac-mediated gene transfer and to maintain the expression of the gene of interest

Bacillus anthracis is a risk class III organism and needs to be handled inside a biosafety level 3-laboratory. A major problem when working with airborne, spore-forming bacteria like B. anthracis are the hazardous aerosols created when using an automated DNA-extraction method to prepare samples suspected to contain the organism. This study has therefore evaluated the possibility of enclosing a DNA-extraction-robot inside an air tight container (glove box). A prototype of a class III safety cabinet (also known as a glove box) was designed and built to enclose a BioRobot EZ1 from Qiagen. The purpose of this prototype was to evaluate the measurements needed to and also the feasibility of working with the robot inside the cabinet. During the manual DNA-extractions, there was some contamination found on the glove box gloves, probably due to the significantly lowered dexterity that was seen with the thick gloves. The enclosing of the robot revealed no obstacles as the machine was very easy to operate. In addition, protocols have been created for the operation of a transportable class III safety cabinet from Germfree available at SVA. The protocols include the different pressure tests that needed before every experiment take place and also decontamination steps before and after each run. Bacillus cereus was used as a model organism for different DNA-extractions, i.e. automated and manual extractions. The extracted DNA was analysed by real-time polymerase chain reaction (PCR). DNA was also extracted and analysed from B. cereus-spores. When using a manual DNA-extraction kit, B. cereus-DNA was detected at the femtogram level, i.e. 10-15 g DNA / PCR. When using the automated BioRobot EZ1, detection level was found to be at 10-16 g DNA / PCR. The PCR-efficiency for the manual kit was 89-90 % for all samples, whereas with the EZ1, efficiency was 99 %, showing the strengths of the magnetic bead separation used by the machine. A novel PCR-machine, the AlphaHelix QuanTyper™, was evaluated and compared to an ABI 7500 with regards to efficiency, speed and consistency. The QuanTyper™ was found to be superior in ramping speeds, performing a 40-cycle real-time PCR-run with melting point analysis in only 14 minutes. The fastest run accomplished on the ABI 7500 took 1 h 40 min. A ready made master mix for PCR was used for most tests (Platinum® SYBR® Green qPCR SuperMix-UDG), but faster and more robust enzymes are available and further studies need to be performed on the QuanTyper™ to fully evaluate the platform. Three target genes in Bacillus anthracis-DNA were analysed in only 38 minutes with efficiencies between 96-104 % for the virulence plasmids and detection at femtogram amount of DNA. This master thesis has addressed rapid pathogen-detection with automated DNA-extraction and novel PCR-technology, coupled with a strong biosafety aspect. The thesis will hopefully contribute to the surprisingly small area of biosafety and safety cabinet research.

Orientador: Renato Peixoto Dagnino
Dissertação (mestrado) - Universidade Estadual de Campinas, Instituto de Geociências
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Resumo: O enlace atual entre ciência, tecnologia e mercado - referido pela palavra tecnociência - tem como exemplo paradigmático as novas biotecnologias. A engenharia genética e o desenvolvimento de organismos geneticamente modificados (OGMs) constituem temas-chave de diversas controvérsias que se estabelecem entre as dimensões tecnocientífica, econômica e social. A pesquisa utilizou o discurso de cientistas brasileiros para mostrar como se constroem e difundem suas concepções de tecnociência. Esses discursos se referem à Comissão Técnica Nacional de Biossegurança (CTNBio), responsável pelos pareceres técnicos sobre OGMs e por assessorar o governo na definição da política de biossegurança. A pesquisa apontou que a política de biossegurança brasileira e a forma como a CTNBio se constituiu e atua não foram determinadas por opções de caráter estritamente "científico". Também permitiu entender como as concepções de tecnociência estão presentes neste contexto. No capítulo conclusivo foi incluída uma proposta de abordagem construtivista engajada para o tratamento das novas biotecnologias.
Abstract: The current link between science, technology and the market - referred to as technoscience - has as an emblematic example the new biotechnologies, among which those related to genetics and the development of genetically modified organisms may be considered key issues for scientific and environmental controversies. Speech fragments from the Brazilian research community are extracted from the current debate to show how those conceptions of technoscience on which they are based are constructed, propagated and legitimized. They refer to the National Biosafety Technical Commission (CTNBio) presented as electronic news by Science Journal (Jornal da Ciência) and as letters, lectures and other public documents. At the end of this dissertation, a relationship between the views of the research community, technoscientific practices and biosafety policies are established. The research points out that the Brazilian biosafety policy and the way that CTNBio was constituted and acts were not determined strictly scientific choices or by the end of uncertainty and clear and consensual boundaries regarding technological risks. Additionally, a normative constructivist approach is suggested as a form of understanding the new biotechnologies.
Mestrado
Mestre em Política Científica e Tecnológica

Trata-se de um estudo descritivo, exploratório, com abordagem de análise quantitativa, cujo objetivo foi verificar os acidentes com material biológico potencialmente contaminado, ocorridos entre acadêmicos de enfermagem de três instituições de ensino de um município do interior paulista. Para a coleta de dados aplicou-se um questionário com questões abertas e fechadas, após a observação dos aspectos ético-legais. Participaram do estudo 355 alunos que estavam presentes em sala de aula por ocasião da coleta de dados e que já realizavam atividades de ensino-aprendizagem. Os dados foram analisados em Epi Info versão 3.4.3. Verificou-se que, 44 (12,4%) estudantes referiram ter sofrido exposição acidental a material biológico. A maioria era do sexo feminino (93,1%), tinha entre 22 a 25 anos (56,8%), cursava o quarto ano do curso de enfermagem (68,1%), em período integral (75%). O número de acidentes mencionados pelos alunos totalizou 55. Quanto ao tipo de exposição, a de pele íntegra foi a mais freqüente (70,9%), seguida de acidente percutâneo (25,5%), exposição em mucosa (1,8%) e pele lesada (1,8%). As topografias mais afetadas nesses acidentes foram os dedos e as mãos (74,6%). As agulhas foram citadas como o objeto causador de 64,3% dos acidentes percutâneos e o sangue foi o material biológico envolvido em 72,7% do total de acidentes. O maior número de acidentes ocorreu na retirada da punção venosa/soro (18,2%), ao puncionar ou coletar sangue (16,4%) e ao aspirar paciente (12,7%). Os alunos não utilizavam Equipamento de Proteção Individual em 49,1 % dos acidentes, embora em mais de 80% das atividades seria recomendado ao menos o uso das luvas de procedimento. Os alunos lavaram o local do acidente em 92,7% dos casos e dois alunos espremeram a área lesada após acidente percutâneo. Em 40% dos acidentes, os estudantes não notificaram a ocorrência aos docentes supervisores; em 38,2% das exposições os alunos não tomaram nenhuma conduta, não notificaram e não procuraram atendimento médico. A maioria dos docentes, quando notificados, orientou seus alunos quanto às condutas corretas e os encaminharam para avaliação médica; um docente, apesar de notificado, ignorou o fato. As situações mais apontadas pelos alunos como as que favoreceram a exposição acidental foram não utilizar Equipamento de Proteção Individual (49,1%) e a desatenção (45,5%). Como sugestões para prevenir e controlar acidentes com material biológico entre alunos, 21,4% referiu a educação permanente/continuada e 19,7% a utilização de Equipamento de Proteção Individual e a conscientização quanto ao uso. Para minimização de acidentes com material biológico potencialmente contaminado, entre alunos de enfermagem, nota-se a necessidade de envolver não apenas os alunos, mas também docentes e profissionais dos campos de ensino-aprendizagem, num programa efetivo de prevenção e controle dos acidentes.
This is a descriptive and exploratory study with a quantitative analytic approach. The aim was to verify the occurrence of accidents involving potentially contaminated biological material among nursing students from three teaching institutions in an interior city of São Paulo State, Brazil. After observing ethical-legal aspects, a questionnaire with open and closed questions was applied for data collection. Study participants were 355 students present in the classroom at the moment of data collection and who had already been involved in practical teachinglearning activities. Data were analyzed in Epi Info version 3.4.3. Forty-four (12.4%) students indicated accidental exposure to biological material. Most of them were female (93.1%), between 22 and 25 years old (56.8%), taking the forth year of the nursing course (68.1%) and studying full-time (75%). The students mentioned 55 accidents. As to the type of exposure, intact skin exposure was the most frequent (70.9%), followed by percutaneous accident (25.5%), mucous membrane exposure (1.8%) and injured skin (1.8%). The most affected topographic areas during these accidents were fingers and hands (74.6%). Needles were mentioned as the causal object in 64.3% of percutaneous accidents and blood was the biological material involved in 72.7% of all accidents. The largest number of accidents occurred when removing venipuncture/serum (18.2%), while puncturing or collecting blood (16.4%) and while aspirating a patient (12.7%). The students were not using Individual Protection Equipment in 49.1% of the accidents, although at least the use of procedure gloves would be recommended in more than 80% of activities. The students washed the accident site in 92.7% of cases and two students squeezed the injured area after a percutaneous accident. In 40% of the accidents, the students did not notify the occurrence to the supervising faculty members; in 38.2% of the exposures, the students did not take any action and neither notified nor looked for medical help. When notified, most faculty members advised their students about correct conducts and referred them for medical evaluation; despite the notification, one faculty member ignored the fact. The situations students most indicated as favoring accidental exposure were not using Individual Protection Equipment (49.1%) and lack of attention (45.5%). As suggestions to prevent and control accidents involving biological material among students, 21.4% mentioned permanent/continuing education and 19.7% the use of Individual Protection Equipment and creating awareness about the use. To minimize accidents with potentially contaminated biological material among nursing students, the need to involve not only students is observed, but also faculty members and professionals from teaching-learning areas, as part of an effective accident prevention and control program.

Trata-se de um estudo descritivo exploratório com abordagem de análise quantitativa, cujo objetivo foi estudar a ocorrência de acidentes com material biológico potencialmente contaminado e os fatores de risco envolvidos entre os alunos do Curso de Odontologia do interior do Estado do Paraná, Brasil. Para a coleta de dados, aplicou-se um questionário contendo perguntas abertas e fechadas. Este instrumento foi aplicado aos alunos após a observação dos aspectos ético-legais. Participaram do estudo 172 alunos da 3ª, 4ª e 5ª série do curso. Destes, 122 (70,9%) alegaram ter sofrido exposição acidental com material potencialmente contaminado. A maioria dos alunos que sofreram exposição acidental é do sexo feminino (61,0%) e estão cursando a 5ª série do curso, a idade predominante ficou entre 20 e 26 anos (86,1%). O número de acidentes mencionados pelos 122 alunos totalizou 448. Quanto ao tipo de exposição, a de pele íntegra foi a mais freqüente, seguida da exposição em mucosa e em 3º o acidente percutâneo perfazendo uma média total de 2,6 acidentes por aluno sendo a média de 0,23 para acidentes percutâneos. As topografias mais afetadas nestas exposições foram os olhos, mãos e dedos, enquanto que as brocas e agulha de anestesia foram citadas como os principais objetos causadores destes acidentes. A situação de ocorrência mais encontrada foi o ato de se utilizar normalmente um instrumental e o momento de realizar a limpeza dos instrumentais. Foi nas disciplinas de Clínica Integrada, Periodontia e Dentística que ocorreram a maioria das exposições. Quanto à severidade, 41,8% das exposições foram consideradas superficiais e 22,1% como moderadas. Apenas 10,7% dos alunos que sofreram exposição procuraram atendimento para avaliação e conduta em relação à exposição, 88,6% dos sujeitos receberam as três doses da vacina contra hepatite B. Observou-se ainda que nem sempre os alunos faziam uso dos Equipamentos de Proteção Individual, sendo que o uso dos óculos de proteção e a utilização de luvas de borracha grossa para realizar a limpeza dos materiais foram os mais negligenciados. Este estudo permitiu concluir que o risco de exposição a material biológico é iminente para esta categoria e que é necessário estabelecer estratégias de intervenção urgentes tanto em nível institucional quanto acadêmico a fim de reduzir estes riscos.
This is an exploratory descriptive study with a quantitative analysis approach, which objective was to study the occurrence of accidents with potentially biologically contaminated material and the risk factors involving the students from the Course of Odontology in the interior of the State of Paraná, Brazil. For the data collection, a questionnaire was applied containing open and closed questions. This instrument was applied to the students after the observation of the ethical-legal aspects. One hundred and seventy two students from the 3rd, 4th and 5th years of the course participated in the study. From these students, 122 (70.9%) alleged to have suffered accidental exposition with potentially contaminated material. Most of the students that suffered accidental exposition were female (61.0%) and they were at the 5th year of the course, the predominant age was between 20 and 26 years old (86.1%). The number of accidents mentioned by the 122 students summed 448. The most frequent kind of accident occurrences was the intact skin, followed by the exposition of mucous membrane and the percutaneous accident which made a total average of 2.6 accidents for each student and the average of 0.23 for percutaneous accidents alone. The most affected areas in these expositions were the eyes, hands and fingers, and the drills and the anesthesia needles were mentioned as the main objects that causes these accidents. The most found occurrence situation was the common action of using an instrument and at the moment of cleaning them. It was in the courses of Integrated Clinic, Periodontics and Dentistics that happened most of the expositions. As for the severity of the cases, 41.8% of the expositions were considered superficial and 22.1% were moderate. Only 10.7% of the students exposed to some kind of injury, sought for a service of checking and possible treatment; 88.6% of the persons received the three doses of the hepatitis B vaccine. It was observed though, that students didn’t usually make use of the Equipments of Individual Protection. The use of the protection glasses and gloves, made of thick rubber at the time of cleaning the materials were the most neglectful. This study allowed us to conclude that the exposition risk to biological material is imminent for this work category and that it is necessary to establish urgent intervention strategies on an institutional or academic level in order to reduce these risks.

Synthetic biology has been defined as: “the design and construction of new biological parts, devices, and systems, and the re-design of existing, natural biological systems for useful purposes” (syntheticbiology.org). The convergence of scientific fields such as molecular biology, computer science and others have rendered it a natural progression, based on existing knowledge.The fact that humanity has reached a stage of development where it seems feasible to “create” life, or design it to a high degree of specificity, is a significant milestone in its history. It generates important ethical questions: Is synthetic biology something good, a natural use of humanity’s talents, or is it a step towards megalomania, playing God, a usurpation of his role? Is it really a natural progression, nature advancing to a state where its products can, in turn, improve nature itself; or does it challenge the dignity of nature by virtue of its “unnaturalness”? Is it an expression of the creative talent of humanity, thus enhancing human dignity, and perhaps that of all life, or does it challenge the dignity of life itself? Regarding its potential consequences, it may, if it succeeds, lead humanity to a new level of development, a paradigm shift comparable with the scientific or industrial revolutions, through a vast increase in scientific knowledge, and subsequent technological developments in all relevant areas, including medicine, food production and fuel development. However, there is potential for serious accidents if synthetic organisms interact with naturally occurring ones, possibly affecting the future course of evolution. Synthetic biology also offers the possibility of creating ever more powerful weapons, more easily than ever before; the technology is reaching a stage where any interested members of the public may be able to create weapons of mass destruction. Synbio is a dual use technology, offering potential for both good and evil. Its potential for either appears to be greater than any other technology that has existed.In this thesis I evaluate the ethics of synthetic biology from the following ethical perspectives – deontology, consequentialism and theology. I am approaching it from several viewpoints so as to give as wide an analysis of the issues as possible. I also evaluate the effectiveness of these standard ethical tools for evaluating synbio ethics. In addition, I examine whether ethics should be more deeply integrated into the day-to-day scientific research in synbio. As a secondary study, I discuss regulation, the main legal issue that synthetic biology generates.

Foram selecionados, aleatoriamente, 12 equipos em 7 clínicas da FOB/USP, dois foram preenchidos com água destilada (Ortodontia e Urgência), um com água de torneira (UBAs), em um o reservatório ficou seco por 30 dias (Odontopediatria) em outro por 60 dias (Pós-graduação), um equipo com a tecnologia B-Safe® (Multidisciplinar) e, em três, a limpeza com o detergente enzimático foi avaliado (Dentística). Amostras de 10 mL de água dos reservatórios e tubulações das canetas de alta rotação foram obtidas e diluições feitas até 10-4, semeadas nos meios de cultura R2A, Peptona Diluída - PD, Plate Count Agar - PCA e Sabouraund Dextrose Agar SDA. Alíquotas de 100 L das amostras foram semeadas nos meios de cultura R2A, PD, PCA e SDA pela técnica de esgotamento, alíquotas de 25 L foram semeadas (R2A, PD, PCA e SDA) pela técnica da gota e alíquotas de 100 L das amostras foram semeadas no meio PCA pela técnica de pour plate. As placas de R2A, PD, PCA foram incubadas por 72 horas a 24°C e as placas de SDA por 4 a 7 dias a 24°C. Foi feita a identificação bacteriana através do kit Bactray I, II ou III e a fúngica através do microcultivo. A média bacteriana obtida foi de 128.151 UFC/mL na Odontopediatria, 1.834.807 UFC/mL na Ortodontia, 60.422 UFC/mL na Pós-Graduação, 615,68 UFC/mL na UBAs, 899,64 UFC/mL na Urgência, 97.632 UFC/mL na Multidisciplinar e 417.619 UFC/mL na Dentística sem limpeza e 135.924 UFC/mL após a limpeza. A média dos fungos foram 205 UFC/mL na Odontopediatria, 702,50 UFC/mL na Ortodontia, 12,50 UFC/mL na Pós-Graduação, 41.475 UFC/mL UBAs, 117.500 UFC/mL Urgência, 4.469 UFC/mL na Multidisciplinar e 64.642 UFC/mL e de 23.627 UFC/mL, antes e após a limpeza na Dentística. A presença de micro-organismos foi detectada nos reservatórios e tubulações de água em todas as 7 clínicas; para quantificar as bactérias, o meio R2A seguido do PD foram melhores que o PCA e, para detectar diferentes espécies o meio PCA foi superior ao R2A e PD; a técnica da gota foi melhor do que a de esgotamento e pour plate para as bactérias, enquanto a de esgotamento foi superior para os fungos. O detergente enzimático foi eficaz em desestruturar o biofilme, atuando mais sobre os fungos do que para as bactérias, que não foram eliminadas após as limpezas. Foram identificadas 22 espécies de bactérias: Acinetobacter baumanni/calcoaceticus, Aeromonas hydrophila, Alcaligenes xylosoxidans denitrificans, Brevundimonas vesicularis, Burkholderia cepacia, Burkholderia pseudomallei, Chromobacterium violaceum, Hafnia alvei, Hafnia alvei (Biogrupo 1), Ochrobactrum anthropi, Pseudomonas aeruginosa, Pseudomonas alcaligenes, Pseudomonas fluorescens, Pseudomonas luteola, Pseudomonas oryzihabitans, Pseudomonas pseudoalcaligenes, Pseudomonas putida, Pseudomonas stutzeri, Serratia liquefaciens, Serratia plymuthica, Sphingobacterium multivorum, Tatumella ptyseos. Foram identificados 12 gêneros de fungos: Acremonium sp, Alternaria sp, Aspergillus sp, Cladosporium sp, Curvularia sp, Exophiala sp, Fonsecaea sp, Fusarium sp, Paecylomices sp, Penicillium sp, Rhinocladiella sp, Verticillium sp.
Twelve dental units of 7 clinics of FOB/USP were randomly selected, two were filled with distilled water (Orthodontics and Urgency), one with tap water (UBAs), one reservoir was dry for 30 days (Odontopediatry) and another for 60 days (Postgraduate Clinic), one dental unit was filled with the B - Safe ® technology (Multidisciplinary Clinic). Three dental clinics were evaluated concerning the cleaning procedure with enzymatic detergent. Samples of 10 mL of water reservoirs and high-speed handpieces were collected and made up to 10-4 dilutions, plated on R2A media, Peptone Diluted culture - PD, Plate Count Agar - PCA and Sabouraund Dextrose Agar - SDA. Aliquots of 100 L of the samples were plated on R2A media, PD, PCA and SDA culture technique for spreading. Aliquots of 25 L were seeded (R2A, PD, PCA and SDA) in drops and aliquots of 100 L samples were seeded in PCA by the pour plate technique. R2A plates, PD, PCA were incubated for 72 hours at 24°C and SDA plates for 4 to 7 days at 24°C. Bacterial identification was performed using Bactray I, II or III kit and fungal identification by microculture. Bacterial average was 128.151 CFU/mL in Odontopediatry, 1.834.807 CFU/mL in Orthodontics, 60.422 CFU/mL in Postgraduate Clinic, 615.68 CFU/mL in UBAs, 899.64 CFU/mL in Urgency, 97.632 CFU/mL in Multidisciplinary Clinic and 417.619 CFU/mL in Dentistry without the cleaning procedure and 135.924 CFU/mL after it. The average of fungi was 205 CFU/mL in Odontopediatry, 702.50 CFU/mL in Orthodontics, 12.50 CFU/mL in Postgraduate Clinic, 41.475 CFU/mL in UBAs, 117.500 CFU/mL in Urgency, 4.469 CFU/mL in Multidisciplinary and 64.642 CFU/mL and 23.627 CFU/mL before and after cleaning procedure in Dentistry. The presence of micro - organisms occurred in reservoirs and waterlines in all of the 7 clinics evaluated. To quantify bacteria, R2A and PD medium provided more accurate results than PCA. To detect different species, PCA medium was better than R2A and PD. The drop technique was better than the spreading technique and pour plate for bacteria; however, the spreading technique provided better results for the yeasts. The enzymatic detergent was effective on disrupting the biofilm eliminating more yeasts than residual bacteria. Twenty-two species of bacteria were identified: Acinetobacter baumanni/calcoaceticus, Aeromonas hydrophila, Alcaligenes xylosoxidans denitrificans, Brevundimonas vesicularis, Burkholderia cepacia, Burkholderia pseudomallei, Chromobacterium violaceum, Hafnia alvei, Hafnia alvei (Biogroup 1), Ochrobactrum anthropi, Pseudomonas aeruginosa, Pseudomonas alcaligenes, Pseudomonas fluorescens, Pseudomonas luteola, Pseudomonas oryzihabitans, Pseudomonas pseudoalcaligenes, Pseudomonas putida, Pseudomonas stutzeri, Serratia liquefaciens, Serratia plymuthica, Sphingobacterium multivorum, Tatumella ptyseos. Twelve genus of fungi were identified: Acremonium sp, Alternaria sp, Aspergillus sp, Cladosporium sp, Curvularia sp, Exophiala sp, Fonsecaea sp, Fusarium sp, Paecylomices sp, Penicillium sp, Rhinocladiella sp, Verticillium sp.

Orientador: Maria Cecília Pereira Binder
Banca: Tarcísio Márcio Magalhães Pinheiro
Banca: Francisco Antonio de Castro Lacaz
Resumo: Estudo epidemiológico descritivo de acidentes ocupacionais envolvendo exposição a material biológico em cirurgiões-dentistas, auxiliares odontológicos, estudantes de Odontologia, atuando na cidade de Bauru-SP, de 2000 a 2004. As fontes de informações foram prontuários e fichas de notificação de acidentes. Os casos foram descritos segundo atributos dos acidentados, serviço de ocorrência, objeto causador da lesão, matéria orgânica envolvida na exposição, circunstância do acidente e coeficiente de incidência. As providências adotadas antes e depois da ocorrência do acidente, bem como acompanhamento sorológico dos acidentados também foram descritos. Comparou-se, para o mesmo período, os resultados obtidos em Bauru com os resultados do SINABIO em profissionais de Odontologia do Estado de São Paulo. Foram identificados 179 acidentes, envolvendo 174 profissionais. O maior número de casos, quarenta e nove, ocorreu em 2000. Houve predomínio de casos em mulheres e em jovens, sobretudo, estudantes de Odontologia. Constatou-se que o procedimento odontológico envolvendo exposição percutânea com agulha contaminada com sangue foi a circunstância do acidente predominante. Sondas, brocas curetas e limas foram outros instrumentos envolvidos. A maioria dos acidentados utilizava luvas e máscara, e estava vacinado contra hepatite B. Observou-se que a realização de Anti-HBs pós vacinal foi efetuada raramente. Grande parte dos pacientes-fonte era conhecido e, destes, apenas 39,2% teve resultados de exames sorológicos para HIV registrados, 10,7% para HBV e 2,1% para HCV. Medicação anti-retroviral foi ministrada em 85,5% dos casos; 3,9% dos acidentados receberam gamaglobulina hiperimune para hepatite B; 19,0 % foram vacinados contra hepatite B. Não foram registradas soroconversões para nenhum dos três vírus considerados (HIV, HBV e HCV)... (Resumo completo, clicar acesso eletrônico abaixo)
Abstract: A descriptive epidemiological study of occupational accidents involving biological material exposure to dentists, dental assistants, and dentistry students in Bauru-SP, from 2000 to 2004. Source information was obtained from patient charts and accident notification forms. All cases were described according to the accident victims' personal and professional details, the location of the accident, the device causing the injury, the organic material exposed to, the circumstances of the accident, and the index of accident incidence. Procedures taken before and after any accident are described, as are the resulting serological proceedings. Results from Bauru were compared with those of dentistry professionals from the State of São Paulo, during the same period, registered by SINABIO (Notification System for Biological accidents of the STD/AIDS programme of the Sao Paulo State Health Organization). 179 accidents were identified, involving 174 professionals. The majority of cases, 49, occurred in 2000. Women and young people were more often affected, being mainly those among dentistry students. The predominant circumstance for accidents registered was during dentistry procedures involving percutaneous exposure with needles contaminated by blood. Other devices involved in accidents were probes, burs, curettes and files. The majority of accident victims were wearing gloves and masks when the accident occurred and were hepatitis B vaccinated. The Anti-HB S reaction test was rarely done. In most cases sources were known, and from these only 39.2% had serological exam results registered for HIV, 10.7% for HBV and 2.1% for HCV. 84.5% of the professionals involved in accidents did not follow all the postexposure... (Complete abstract click electronic access below)
Mestre

Створити та впровадити в практику регламентуючий документ для безпечної роботи з колекцією штамів бруцел у відповідності до Європейських вимог з біобезпеки та біозахисту.
The Regulations for National Brucella strains collection maintenance was developed in accordance with the European requirements for biosafety and biosecurity. This regulatory document was implemented in the process of research and practical work in the Brucellosis laboratory of NSC IECVM. The effectiveness of these Regulations has been proven.

Для України питання біобезпеки генетично модифікованих організмів є актуальною у зв'язку з відсутністю та недостатнім розвитком, на даний момент, матеріально-технічної, законодавчої та нормативно-правової бази з питань забезпечення державного контролю у відповідній сфері державної політики. При цитуванні документа, використовуйте посилання http://essuir.sumdu.edu.ua/handle/123456789/14234

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Fiocruz. Centro de Desenvolvimento Tecnológico em Saúde
O tema biossegurança é de grande relevância para o desenvolvimento do país nas áreas da saúde, ciência e biotecnologia. A regulamentação deste tema no Brasil é caracterizado por documentos pulverizados, editados por diferentes órgãos governamentais, que não interagem efetivamente, gerando incertezas para a comunidade cientifica e a sociedade. Há a necessidade do desenvolvimento, análise, consolidação e harmonização dos documentos nacionais de referência de biossegurança visando tornar mais clara e eficaz a compreensão e aplicação dos requisitos. O presente trabalho visa realizar uma análise crítica dos documentos nacionais de referência vigentes e elaborar uma proposta de um modelo consolidado e harmonizado de um Manual de Biossegurança para a área da saúde, com a finalidade de subsidiar a definição de critérios de forma mais clara. Para este fim, foram identificados e analisados os documentos nacionais que tratam do tema biossegurança, a saber: Diretrizes Gerais para o Trabalho em Contenção com Agentes Biológicos (Ministério da Saúde, 2010); Resolução Normativa nº 02, de 27 de novembro de 2006 (Ministério da Ciência, Tecnologia e Inovação); Norma Regulamentadora - NR.32 - Segurança e Saúde no Trabalho em Serviços de Saúde (Ministério do Trabalho e Emprego, 2011) e Diretrizes para Projetos Físicos de Laboratórios de Saúde Pública (FUNASA, 2007). Em seguida, definiu-se três macrotemas para a análise comparativa: Utilidades, Infraestrutura e Equipamentos. Cada macrotema foi abordado em função de temas mais específicos e palavras-chave que refletissem os principais critérios utilizados para assegurar as condições de biossegurança de uma instalação laboratorial de saúde, os quais foram utilizados para a busca do tema em cada documento de referência. Cada requisito foi analisado e consolidado, criando-se uma redação única, que harmoniza todos os documentos nacionais de referência. Foram geradas tabelas consolidando, para cada macrotema, em cada nível de segurança biológico (NB-1, NB-2 e NB-3), os temas e requisitos observados nos documentos nacionais de referência. A partir de cada tabela foi possível identificar os aspectos comuns e omissos nestes documentos e estabelecer um texto propositivo consolidado para cada tema, harmonizando-os. Como produto, foi elaborado um documento harmonizado como proposta de um Manual de Biossegurança para a área da saúde a ser considerado pela Fiocruz e Inmetro. Este documento consolidou e/ou harmonizou os documentos nacionais de referência de biossegurança brasileiros editados por diferentes órgãos governamentais, de modo a subsidiar a discussão e definição de requisitos para a estruturação de um Programa de Avaliação da Conformidade Laboratorial em Segurança Biológica. A análise dos resultados obtidos permitiu concluir que os documentos nacionais de referência não se apresentam completos para todos os requisitos de biossegurança e, em alguns casos, há requisitos fundamentais não contemplados. O Manual de Biossegurança para a área da saúde proposto supera tal limitação por conter todos esses requisitos. Adicionalmente, o documento proposto agrega requisitos ainda não contemplados, visando aproxima-lo das normas técnicas internacionais atuais.
The issue of biosafety is of great importance for the country's development in health, Science and biotechnology. The regulation of biosafety in Brazil is characterized by several standards issued by different government agencies, that do not interact effectively, creating uncertainties for the scientific community and society. There is the need for development, analysis, consolidation and harmonization of Brazilian biosafety laws/rules issued by diferente government agencies, in order to make the comprehension and application of these laws more effective and widespread. This study carried out a critical analysis of the existing legislation in biosafety and produced a draft for a consolidated and harmonized model of a technical Biosafety Guidelines for laboratories acting in the area of health in order to support the definition of criteria and the most appropriate approach for structuring a future Program in Assessment of Laboratory Conformity in Biosafety. To accomplish this, the national documents dealing with the issue of biosafety were identified and critically analyzed. The documents included: Diretrizes Gerais para o Trabalho em Contenção com Agentes Biológicos (Ministério da Saúde, 2010); Resolução normativa nº 02, de 27 de novembro de 2006 (Ministério da Ciência, Tecnologia e Inovação); Norma Regulamentadora - NR.32 - Segurança e Saúde no Trabalho em Serviços de Saúde (Ministério do Trabalho e Emprego, 2011) and Diretrizes para Projetos Físicos de Laboratórios de Saúde Pública (FUNASA – 2007). The content of the documents was divided into three main issues for comparative analysis: Utilities, Infrastructure and Equipment. Each issue was further subdivided into more specific topics and ascribed keywords, that reflect the main criteria used to ensure biosafety conditions of a laboratory acting in the area of health, which were used for to search for the topics within each reference document. Each requirement was analyzed and consolidated, creating a single text, which harmonizes all the existing laws and regulations, formulated into a single reference document. As a result, consolidated tables were developed for each main issue at each biosafety level, with the issues and requirements observed in the legislation. From each table it was possible to critically identify common issues and omissions in legislation and establish a consolidated text for the purpose of harmonizing them against current legislation. The product of this process, was a harmonized document in the form of a Biosafety Guidelines to be considered by Fiocruz and Inmetro. This document consolidated and/or harmonized the existing Brazilian biosafety laws/rules, issued by different government agencies in order to offer a platform for the discussion and definition of requirements for structuring a Program in Assessment of Laboratory Conformity in Biosafety. Based on the analysis of the results, it was concluded that the multiple national standards are incomplete in relation to all biosafety requirements and, in some cases, there are fundamental requirements that are not covered. The proposed Biosafety Guidelines overcomes those limitations and also standardizes the requirements for biosafety in healthcare laboratories. In addition, the proposed Guidelines consider and add requirements not contemplated in the national legislation in order to bring it into line with current international standards.

El plasma dessecat per atomització (SDP) és una font de proteïnes funcionals obtinguda a partir de sang d’animals sans, aprovats per les autoritats veterinàries per al consum humà. La sang es recull a l'escorxador, es tracta amb anticoagulant, es refreda i es transporta a instal·lacions industrials on es centrifuga per separar els glòbuls vermells de la fracció plasmàtica. Després, el plasma es concentra i s'asseca a altes temperatures (80ºC) per convertir-lo en pols. Aquest mètode conserva l’activitat biològica de les proteïnes. El SDP s’utilitza principalment en dietes de porcí per millorar significativament el guany diari, la ingesta, l’eficiència productiva i per reduir el retard causat per l’aparició de diarrea després del deslletament. Tot i que el SDP es considera un producte segur i el seu procés de fabricació consta diverses etapes de bioseguretat, la seva seguretat sovint es qüestiona donada la seva naturalesa de subproducte hemoderivat, especialment quan apareixen patògens emergents o reemergents. Aquesta tesi doctoral es va centrar en l'avaluació i la validació d'una nova etapa redundant d'inactivació de patògens per a implementar en el procés de producció de SDP, la irradiació UV-C. El treball ha consistit en avaluar l’efectivitat del tractament per irradiació UV-C mitjançant un dispositiu de flux turbulent, SurePure TurbulatorTM, a l’irradiar un plasma natiu inoculat artificialment amb diferents patògens d’interès per a la indústria porcina. Als estudis 1 i 2 es va avaluar l’efecte UV-C sobre la supervivència de Salmonella typhimurium, S. choleraesuis, Enterococcus faecium i Escherichia coli K88 i K99 sotmesos a diferents dosis UV-C. Es van trobar cinètiques d'inactivació no lineal amb un valor de reducció de 4 log10 (4D), proper a 3000 J/L en tots els casos. A l’estudi 3 es va analitzar l’efecte de l’UV-C sobre diferents virus d’interès en la indústria del porcí. La selecció de virus amb envolta va incloure el Virus de la pseudoràbia (PRV), el Virus de la síndrome respiratòria i reproductiva porcina (PRRSV), el Virus de la diarrea epidèmica porcina (PEDV), el Virus de la diarrea viral bovina, el Virus de la grip porcina (SIV) i el Virus de la pesta porcina clàssica (CSFV); i, com a virus sense envolta, el Parvovirus porcí (PPV), Virus de la malaltia vesicular de porc (SVDV), Circovirus porcí 2 (PCV-2) i Senecavirus A (SVA). Tots aquests virus van ser sotmesos a diferents dosis UV-C i, mitjançant la titulació de les mostres, es va construir la seva corba d'inactivació. En termes generals, els resultats van mostrar que els virus amb envolta tenen una sensibilitat superior a l’UV-C, amb valors 4D inferiors a 2000 J/L, que els que no presenten envolta, presentant valors propers a 3000 J/L o més. A l’estudi 4 es va dur a terme un bioassaig utilitzant diferents grups de garrins, inoculats intraperitonealment amb plasma irradiat per UV-C a 0 J/L (plasma no tractat), 3000 i 9000 J/L. Els resultats van mostrar que cap dels porcs dels grups que rebien el plasma irradiat per UV-C es va infectar ni va seroconvertir en front als virus detectats al plasma inicial (PCV-2, PRRSV (soques europees), SIV, PPV, Virus de l’hepatitis E i Rotavirus A), confirmant així l’eficàcia de l’UV-C. Alhora, es varen dissenyar mètodes convencionals de PCR per amplificar amplicons llargs dels genomes de PCV-2 i PEDV. Mitjançant la comparació dels resultats amb els de PCRs quantitatives, es va demostrar que l’UV-C va ser capaç de danyar el genoma viral. Els resultats globals de la present tesi doctoral mostren que l’aparell d’UV-C SurePure TurbulatorTM és eficaç inactivant un ampli ventall de bacteris i virus presents de forma natural en plasma animal líquid recollit d’escorxadors comercials.
El plasma secado por atomización (SDP) es una fuente de proteína funcional obtenida de la sangre de animales sanos, aprobada por las autoridades veterinarias para el consumo humano. La sangre se recoge en el matadero, se trata con anticoagulante, se enfría y se transporta a instalaciones industriales en las que se centrifuga para separar los glóbulos rojos de la fracción plasmática. Luego, el plasma se concentra y se seca por atomización a altas temperaturas (80°C) para convertirlo en polvo. Dicho método conserva la actividad biológica de sus proteínas. El SDP se usa principalmente en dietas porcinas para mejorar significativamente la ganancia diaria, la ingesta, la eficiencia de producción y para reducir el retraso causado por la aparición de diarrea posterior al destete. Aunque el SDP se considera un producto seguro y su proceso de fabricación consta de varias etapas de bioseguridad, su seguridad a menudo se cuestiona debido a su naturaleza de subproducto hemoderivado, especialmente cuando aparecen patógenos emergentes o reemergentes en las poblaciones animales. Esta tesis doctoral se centró en la evaluación y validación de una nueva etapa redundante de inactivación de patógenos a implementar en el proceso de fabricación de SDP, la radiación UV-C. El trabajo ha consistido en evaluar la efectividad del tratamiento de irradiación con UV-C utilizando un dispositivo de flujo turbulento, SurePure TurbulatorTM, al irradiar plasma inoculado artificialmente con diferentes patógenos de interés para la industria porcina. En los estudios 1 y 2, el efecto UV-C sobre la supervivencia bacteriana se evaluó sobre Salmonella typhimurium, S. choleraesuis, Enterococcus faecium y Escherichia coli K88 y K99, sometidas a diferentes dosis de UV-C. Todas las bacterias analizadas mostraron una cinética de inactivación no lineal con un valor de reducción de 4 log10 (4D) cercano a 3000 J/L en todos los casos. En el estudio 3, se analizó el efecto de UV-C en diferentes virus de interés. La selección de virus con envuelta incluyó el Virus de la pseudorabia (PRV), Virus del síndrome respiratorio y reproductivo porcino (PRRSV), Virus de la diarrea epidémica porcina (PEDV), Virus de la diarrea viral bovina (BVDV), Virus de la influenza porcina A (SIV) y el virus de la peste porcina clásica (CSFV). El Parvovirus porcino (PPV), Virus de la enfermedad vesicular porcina, Circovirus porcino 2 (PCV-2) y Senecavirus A (SVA) fueron elegidos como virus sin envuelta. Los virus se sometieron a diferentes dosis de UV-C y, mediante la titulación de las muestras, se construyó su curva de inactivación. Los resultados mostraron que los virus envueltos tienen una mayor sensibilidad al l UV-C, con valores 4D inferiores a 2000 J/L, que los no envueltos, con valores 4D alrededor de 3000 J/L o superiores. En el estudio 4 se realizó un bioensayo utilizando diferentes grupos de lechones inoculados por vía intraperitoneal con plasma irradiado por UV-C a 0 (plasma no tratado), 3000 y 9000J/L. Ninguno de los cerdos en los grupos que recibieron el plasma irradiado por UV-C presentó infección o seroconversión frente a los virus cuyo genoma se detectó en el plasma inicial (PCV-2, PRRSV (cepas europeas), SIV, PPV, Virus de la hepatitis E y Rotavirus A), lo que confirma la eficacia de UV-C. Además, se diseñaron PCR convencionales para amplificar amplicones largos de los genomas de PCV-2 y PEDV. Al comparar los resultados con los obtenidos por PCR cuantitativa en tiempo real, se demostró que la UV-C podía dañar el genoma viral. Los resultados generales de la presente tesis doctoral demuestran que el diseño del turbulador SurePure UV-C fue eficaz para inactivar una amplia gama de bacterias y virus presentes de forma natural en el plasma animal líquido comercial.
Spray dried plasma (SDP) is a functional protein source obtained from blood of healthy animals, approved by the veterinary authorities to be fit for slaughter for human consumption. Blood is collected at the slaughterhouse, treated with an anticoagulant, chilled and transported to industrial facilities in which blood is centrifuged to separate the red blood cells from the plasma fraction. Plasma is then concentrated and spray dried at high temperatures (80ºC throughout its substance) to convert it in a powder. Such method preserves the biological activity of its proteins. SDP is mainly used in pig feed diets to significantly improve daily gain, feed intake, production efficiency, and to reduce post-weaning lag caused by the appearance of post-weaning diarrhea. Although SDP is considered a safe product and its manufacturing process consists of several biosafety steps, the security of the SDP is often questioned due to its nature as raw blood by-product, especially when emergent or re-emergent pathogens appear in animal populations. This PhD Thesis focused on the evaluation and validation of a new redundant pathogen inactivation step that may be implemented in the manufacturing process of SDP, the UV-C irradiation. The work has consisted in evaluating the effectiveness of the UV-C irradiation treatment using a turbulent flow device, SurePure TurbulatorTM, when irradiating raw plasma artificially inoculated with different pathogens of interest for the swine industry. In studies 1 and 2 the UV-C effect on bacterial survival was assessed on Salmonella typhimurium, S. choleraesuis, Enterococcus faecium, and Escherichia coli K88 and K99 strains subjected to different UV-C doses. All tested bacteria showed non-linear inactivation kinetics with 4 log10 (4D) reduction value in all cases close to 3000 J/L. In study 3, the effect of UV-C on different viruses of interest in the swine industry was analyzed. The selection of enveloped viruses included Pseudorabies virus, Porcine reproductive and respiratory syndrome virus (PRRSV), Porcine epidemic diarrhea virus (PEDV), Bovine viral diarrhea virus, Swine inflenza A virus (SIV) and Classical swine fever virus. On the other hand, Porcine parvovirus (PPV), Swine vesicular disease virus, Porcine circovirus 2 (PCV-2) and Senecavirus A (SVA) were chosen as non-enveloped viruses. All these viruses were subjected to different UV-C doses and, by titration of the samples at each UV-C dose, the inactivation curve for each virus was constructed. In general terms, results showed that enveloped viruses have a higher sensitivity to UV-C than non-enveloped ones, being the 4D values less than 2000 J/L for enveloped viruses and around 3000 J/L or higher for non-enveloped ones. To validate the effectiveness of the plasma UV-C irradiation measured in previous studies, a bioassay was carried out in the study 4 using different groups of piglets inoculated intraperitoneally with UV-C irradiated plasma at 0 (untreated plasma), 3000, and 9000J/L. The results showed that none of the pigs in the groups that received the plasma irradiated by UV-C were infected or seroconverted against the viruses which genome was detected in the initial plasma (PCV-2, PRRSV (European strains), SIV, PPV, Hepatitis E virus and Rotavirus A), thus confirming the efficacy of UV-C. Furthermore, in the study 4, conventional PCR methods able to generate long amplicons were designed to amplify fragments of approximately 1.7 kb of PCV-2 and PEDV genomes. By comparison of the results with those of real time quantitative PCRs to detect the same viruses (using short amplicons), it was demonstrated that UV-C was able to damage the viral genome. Overall results of the present PhD Thesis showed that the SurePure UV-C Turbulator design was effective in inactivating a wide range of bacteria and viruses spiked and naturally present in commercially collected liquid animal plasma.

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Professional practice is also guided by the teaching- learning and knowledge in biosafety training of pharmacists , is of paramount importance for the safe and conscientious professional practice . The study aims to investigate the knowledge of undergraduate students about concepts of biosafety aspects in the use of personal protective equipment , standard precautions and immunization . A questionnaire was applied to interview students of pharmacy of a public institution to collect data on biosafety , during the period November 2012 to May 2013. Among the 300 participants , 132 ( 64.4 %) use lab coat and glove 240 ( 80 % ) have knowledge of waste disposal , 246 ( 82 % ) know about measures to protect the safety and health of workers in health services , 289 ( 96 % ) know the correct handwashing and 71 ( 26 % ) reported knowledge of occupational immunization. It was observed that approximately 65 % of the students showed biosafety knowledge and this knowledge did not show the expected periods over the course of the addition. There is need for changes in teaching strategies to be effective in practice biosecurity as essential to professional practice safely content, reaffirming content as transversal and interdisciplinary .
A prática profissional se orienta também pelo processo de ensino-aprendizagem e o conhecimento em biossegurança na formação dos farmacêuticos, é de suma importância para o exercício profissional seguro e consciente. O estudo tem por objetivo investigar o conhecimento de graduandos acerca de conceitos de biossegurança nos aspectos da utilização de equipamentos de proteção individual, precauções-padrão e imunização. Aplicou-se questionário para entrevistar alunos do curso de farmácia de uma instituição pública para coleta de dados sobre biossegurança, durante o período de novembro de 2012 a maio de 2013. Dos 300 participantes, 132 (64,4%) utilizam jaleco e luva, 240 (80%) tem conhecimento sobre descarte de resíduos, 246 (82%) sabem sobre medidas de proteção à segurança e a saúde de trabalhadores dos serviços de saúde, 289 (96%) conhecem a higienização correta das mãos e 71 (26%) relataram conhecimento acerca de imunização ocupacional. Observou-se que aproximadamente 65% dos graduandos mostraram conhecimento em biossegurança e esse conhecimento não apresentou o acréscimo esperado ao longo dos períodos do curso. Há necessidade de mudanças nas estratégias de ensino para se efetivar na prática a biossegurança como conteúdo imprescindível ao exercício profissional com segurança, reafirmando o conteúdo como transversal e interdisciplinar.

Esta dissertação analisa como o Direito, do ponto de vista da biossegurança, tem mediado as divergências inerentes à inserção de organismos geneticamente modificados (OGMs) no meio ambiente e como tem tratado seus impactos na natureza em relação às futuras gerações. Para estudar esse tema, analisa-se o princípio da precaução como critério para a liberação desses OGMs. Percebe-se que a efetividade do princípio da precaução exige a aplicação do direito à informação, utilizado como ferramenta essencial para que a sociedade tenha pleno conhecimento para uma escolha consciente do que consome. A utilização do princípio da precaução e do direito à informação na inserção dos OGMs recebe, neste trabalho, a ênfase na proteção das futuras gerações, com um recorte teórico nos ensinamentos de Jürgen Habermas a respeito do “Futuro da Natureza Humana” e de Hans Jonas à luz do “Princípio Responsabilidade”. O tema discutido neste trabalho encontra aderência com a linha de pesquisa “Direito Ambiental, Políticas Públicas e Desenvolvimento Socioeconômico” do mestrado em Direito, pois apresenta de forma transversal discussões sobre possíveis impactos da inserção de OGMs no meio ambiente e, consequentemente, reflexos para as futuras gerações. Estas análises poderão subsidiar o aperfeiçoamento de políticas públicas, das teorias relacionadas ao direito ambiental, e ainda, possibilitar o desenvolvimento socioeconômico de forma que sejam minimizados os riscos para as futuras gerações. O método utilizado é qualitativo e de caráter descritivo, e a estratégia de pesquisa adotada é a bibliográfica. Como resultado, conclui-se pela necessidade de mudança ética nas atividades humanas, permitindo que se pense nas atuais e nas futuras gerações, de forma a buscar um meio ambiente equilibrado e sadio para todos. Percebese, no entanto, a falta de cautela na inserção dos OGMs no meio ambiente e a pouca informação que os mesmos possuem, principalmente no que se refere aos possíveis riscos para a saúde e meio ambiente. Por isso, é importante que se tenha maiores informações sobre os organismos geneticamente modificados, juntamente com uma fiscalização pelos órgãos de proteção do meio ambiente, para que todo cidadão possa ficar mais atento em relação ao que deseja consumir ou não.
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This master's dissertation analyzes how the Law, from the point of view of biosafety, has mediated the differences inherent in the inclusion of genetically modified organisms (GMOs) into the environment and how it has treated its impacts on nature to future generations. To study this issue, it analyzes the precautionary principle as a criterion for releasing these GMOs. It is noticed that the effectiveness of the precautionary principle requires the application of the right to information, which is used as an essential tool for society to have full knowledge to a conscious choice than it consumes. The use of the precautionary principle and the right to information in the insertion of GMOs receives, in this work, the emphasis on the protection of future generations, with a theoretical cut the thesis of Jürgen Habermas about the "Future of Human Nature" and the theory of Hans Jonas about the "Principle of Responsibility". The topic discussed in this work is compliance with the line of research "Environmental Law, Public Policy and Socio-Economic Development" of the Master in Law, since it has transversely discussions on possible GMOs insertion of impacts on the environment and hence effects for future generations. These analyzes will support the improvement of public policies, theories related to environmental Law, and also enable the socio-economic development in a way that risks are minimized for future generations. The method used is qualitative and descriptive, and the research strategy adopted is to literature. As a result, concludes the need for ethical change in human activities, allowing them to think about the present and future generations, in order to seek a means balanced and healthy environment for all. It is understood, however, lack of caution in the insertion of GMOs on the environment and the little information that they have, especially with regard to possible risks to health and the environment. So it is important to have more information on genetically modified organisms, along with an inspection by the environmental protection agencies, so that every citizen can become more careful about what they want to eat or not.

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
O presente trabalho tem por objetivo analisar o importante papel desempenhado pelo Princípio da Precaução (PP) no cenário atual, ou seja, em um contexto de grandes avanços tecnológicos, notadamente no que se refere às atividades biotecnológicas, o que vem proporcionando à sociedade, ao mesmo tempo, tanto sentimentos de esperança por um futuro promissor quanto incertezas de eventuais riscos à saúde das pessoas e ao meio ambiente. Busca-se, com isso, demonstrar as preocupações éticas em torno do tema que, em razão de sua natureza, por envolver interesses ligados à vida humana e à proteção ao meio ambiente, deram impulso ao desenvolvimento dos Princípios Bioéticos. Assim, discute as interrelações existentes entre esse novo ramo do saber e o tratamento dado às questões ligadas à biotecnologia. E, em razão da relevância em torno destes fatos e as conseqüências que lhe são inerentes, entende-se como inevitáveis as influências no âmbito jurídico, destacando-se a criação de novos institutos jurídicos, que surgem enquadrados no novo ramo do Biodireito. Ressalta-se, assim, a importância do Princípio da Precaução para o melhor e adequado tratamento dos problemas envolvendo biossegurança, seja do ponto de vista bioético, seja do ponto de vista biojurídico, tendo em vista a sua inserção no ordenamento jurídico pátrio, sobretudo diante de previsão expressa trazida pela Lei n.º 11.105/05. Procuramos demonstrar como o seu surgimento se dá juntamente com a evolução do conhecimento que, em razão de seu avanço, cria maiores possibilidades de intervenção do ser humano no meio ambiente e em seu próprio organismo. Destacamos, por fim, os seus mais importantes aspectos no momento de se determinar a responsabilidade em biossegurança tendo em vista as normas atualmente previstas no âmbito da atual Lei de Biossegurança. Assim, através da análise legislativa, doutrinária e jurisprudencial...
This essay has as objective an analysis of the significant role of the Precautionary Principle (PP) in the present scene, that’s it, the stage of grand technologic leaps, notably in regard to biotech activities, which is providing, at the same time, many feelings of hope for a promising future and uncertainties and occasional health and environmental risks to the society. We seek, with that, to demonstrate the ethical concerns around a subject which, by its own nature, involves connected interests to the human and wildlife conservation that started the development of Bioethics principles. In that way, the existing inter-relations between this new branch of knowledge and its treatment in view of the questioning about biotechnology are discussed. And, given the importance around these facts and its inherent results, its influence to the legal sphere are taken as inevitable, distinguishing the creation of new legal institutes, fitted in the new branch of BioLaw. It stands out the importance of Precautionary Principle to better and adequate deal with biosafety issues, be it from the bioethics, or the BioLaw point of view, because of its national legal arrangement insertion, mainly on account of the expressed due conveyed by Law no. 11.105/05. We evince that its emergence occurs along with the development of knowledge, and because this development, more possibilities of human intervention in the environment and in its own organic structure are created. At last, we take note of the important aspects when determining biosafety responsibilities, in light of the Biosafety Law precepts at present. Thus, with legislative, doctrinal, and jurisprudential analysis, and by means of deductive-intuitive method, through a criticdialectic approach on the topic, we evidence, finally, the means by which an PP adjustment to the national reality will be made, so that it will not hinder involved interests on biotech research, to the extent that its conceptual...

The present thesis deals with the international legal consequences of the Biosafety Protocol. If this Protocol answers the problem of GMOs, by enforcing the application of the precautionary principle to the international trade of genetically modified organisms (GMOs), it does not solve the conflict between the interests of trade and those of the environment. On the contrary, the Biosafety Protocol conflicts with the rules of the GATT and the national norms inspired by it would risk being contested before the dispute-settlement institutions of the World Trade Organisation. The Protocol therefore constitutes a new element in the conflict, pre-existing and unsolved, which sets the implicit supremacy of the GATT against the international environmental norms. It confirms the necessity to find a solution enabling the equal authority and mutual respect of the international environmental and trade rules.
All information is correct as at 14 November 2000.

Genetically modified organisms (GMOs) have been heavily traded across borders since their first commercialisation in 1996, despite the fierce global debates on their benefits and risks. International trade in GMOs are regulated mainly through the WTO Agreements and the Cartagena Protocol on Biosafety (the Protocol) at the international level. The treaties are not necessarily always consistent with one another. Their relationship also serves as a specific example of the much debated potentially conflicting relationship between trade and environment, and the particular phenomenon of the fragmentation of international law that sows the seed for conflict of international norms. Against this background, it is pertinent to ask if there really is the potential for conflicts between the treaties. Also, how do the general international rules on conflict of norms apply to the specific relationship between the treaties? In addition, if necessary, how best might conflicts between international treaties be dealt with or avoided in general? This thesis starts by looking at the substances of the treaties and finds that there exists the real potential for conflict. It then examines the general international rules on conflict resolution techniques, tests them on the potentially conflicting relationship between the WTO Agreements and the Protocol, and finds that existing rules could not provide definitive solutions where conflicts between the treaties arise. It is a central argument of this thesis that conflicts between the treaties should be proactively avoided rather than resolved when disputes actually arise. More generally, with the aim of achieving sustainable development and the defragmentation of international law, the principle of systemic integration is set out as a tool which is generally used by international judicial bodies for viewing international law as a whole, as well as a viable means for avoiding conflicts between international norms. The thesis then sketches the theoretical underpinnings of the principle of systemic integration, including the principles of mutual supportiveness, good faith, cooperation, and harmonisation, and argues that the principles that lie behind systemic integration are capable of driving integration at other levels, including institutional and domestic levels. The thesis also includes an original empirical research undertaken in the form of interviews with state and international organisation representatives, which reaffirms and provides empirical evidence for the doctrinal arguments in this thesis.

Orientador: Laymert Garcia dos Santos
Tese (doutorado) - Universidade Estadual de Campinas, Instituto de Filosofia e Ciências Humanas
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Resumo: A aplicação comercial da tecnologia de transgenia agrícola a partir do final do século XX e a disseminação de seu uso no início do século XXI implicam não somente a rápida e radical transformação do setor agrícola mundial, agora tecnologizado em todas as esferas do processo produtivo, mas sobretudo transformações radicais no significado da sementes e da vida, com impactos econômicos, sociais e ambientais ainda em aberto. A utilização da tecnologia de transgenia no mundo é entendida como um vetor estratégico de dominação, promoção de conflitos políticos e sociais, bem como de ruptura de referenciais de várias ordens na sociedade moderna. A tese analisa os processos de inserção comercial de sementes transgênicas nas sociedades brasileira e argentina a partir de 1990 (principalmente a partir dos Governos Fernando Henrique Cardoso e Carlos Menem). Como elementos fundamentais dessa análise, faz-se referência à construção da transgenia agrícola como um problema de ordem socioambiental no Brasil através da discussão sobre os seguintes elementos: a articulação da sociedade civil organizada brasileira e as consequências de sua mobilização, a construção da política nacional de biossegurança e a estrutura de pesquisa em biotecnologia no país. No caso Argentino, discute-se a expansão do modelo sojeiro, a estrutura de decisão técnica e política sobre biotecnologia e segurança, a dificuldade na construção de diálogo entre a sociedade civil organizada argentina e os âmbitos de decisões tecno-políticas governamentais. Demonstra-se que a tecnologia produz diferentes padrões de ações nas sociedades em que é incorporada comercialmente. Esses padrões de ações são reflexo de parecidos, porém distintos, contextos políticos, econômicos e sociais, em que a mobilização e contestação social merecem destaque
Abstract: The commercial use of transgenic seeds in agriculture since the end of the 20th century and its disseminated use in the beginning of the 21st century lead not only to radical changes in the world's agriculture sector, now technologized in all spheres of the productive process, but also to radical changes into the concepts of seeds and life, with economic, social and environmental impacts that remain open. The use of transgenics in the world is comprehended as a strategic element of a domination process, as a trigger of social and political conflicts, so as an element of rupture of many references. The thesis analyses the commercial introduction of transgenics seeds in the Brazilian and Argentinean societies since 1990 (especially after Fernando Henrique Cardoso and Carlos Menem were elected). As fundamental elements of this analysis, reference is made to the construction of transgenics as a socioenvironmental problem in Brazil through the following aspects: the organizational model of the Brazilian civil society and the consequences of its mobilization, the construction of the national policy on biosafety, and the development of biotechnology research. In regard to Argentina, the thesis touches upon the expansion of the soy model, the technical and political decision making process regarding biotechnology and biosafety, the intricacies of the participation and political dialogue among the Argentinean organized civil society and the technical and political decision making agencies and processes. The thesis illustrates that the technology produces different patterns of action on the societies it is commercially incorporated. These patterns reveal similar but diverse political, economical and social contexts, wherein the social resistanceand mobilization are issues are emphasized
Doutorado
Aspectos Sociais de Sustentabilidade e Conservação
Doutor em Ambiente e Sociedade

CoordenaÃÃo de AperfeÃoamento de Pessoal de NÃvel Superior
CoordenaÃÃo de AperfeiÃoamento de Pessoal de NÃvel Superior
Dentre os vÃrios microrganismos entomopatogÃnicos utilizados no controle biolÃgico, o Bacillus thuringiensis (Bt) vem sendo considerado uma das alternativas mais viÃveis, devido à presenÃa de proteÃnas inseticidas em seus esporos, como as δ-endotoxinas Cry. As toxinas Cry apresentam atividade contra diferentes ordens de insetos, como Coleoptera, Diptera, Hymenoptera, Hemiptera e Lepidoptera. Tais proteÃnas sÃo altamente especÃficas, ou seja, sÃo inÃcuas para a maioria dos organismos nÃo-alvo, fato que favorece sua utilizaÃÃo na agricultura. Hoje existem mais de 114 milhÃes de hectares de lavouras geneticamente modificadas e 37% expressam traÃos de proteÃnas inseticidas de Bt. Como os organismos geneticamente modificados (OGMs) estÃo se tornando cada vez mais predominantes, vÃrias organizaÃÃes internacionais tÃm dado orientaÃÃes no sentido de investigar a seguranÃa de alimentos provenientes de OGMs. Este trabalho teve como objetivo utilizar uma abordagem toxicoproteÃmica para anÃlise de risco da proteÃna recombinante Cry1Ac de Bt a fim de contribuir para uma maior compreensÃo de seus efeitos em modelo de mamÃferos. O ensaio de toxicidade foi conduzido de acordo com o protocolo 425 da âOrganizaÃÃo para a CooperaÃÃo e Desenvolvimento EconÃmicoâ - OECD e nÃo foram verificadas mortes ou sinais de toxicidade. As anÃlises proteÃmicas baseadas em gel mostraram 4 proteÃnas diferencialmente expressas Serpina α-1, Serpina A3K, CininogÃnio e Complemento C3. Essas proteÃnas tiveram uma reduÃÃo em sua expressÃo no grupo tratado com a toxina Cry1Ac. Na abordagem âgel-freeâ foram identificadas 7 proteÃnas diferencialmente expressas. Dentre elas, fator I, inibidor de tripsina H3, plasminogÃnio, serpina A6, albumina e proteÃna resistente à oxidaÃÃo apresentaram uma expressÃo maior em animais tratados com Cry1Ac, enquanto que a protrombina teve sua expressÃo reduzida em animais tratados com a mesma proteÃna. Tais molÃculas sÃo importantes para hemostasia e sistema imune, podendo interferir no processo inflamatÃrio, na ativaÃÃo da via do complemento e da cascata de coagulaÃÃo. No entanto, a abordagem toxicoproteÃmica adotada mostra-se Ãtil para a identificaÃÃo de efeitos adversos, atà mesmo de uma jà amplamente conhecida por sua baixa toxicidade. Isso encoraja a utilizaÃÃo da referida abordagem para a avaliaÃÃo de risco de proteÃnas recombinantes. Apesar das alteraÃÃes fisiolÃgicas causadas, a proteÃna Cry1Ac ainda à considerada segura jà que tais alteraÃÃes ocorreram na dose mais alta recomenda pela OECD (2000mg/Kg) e sem causar morte dos animais.
Among the various pathogenic bacteria used in biological control, Bacillus thuringiensis has been considered one of the most viable alternatives, due to the presence of insecticidal proteins in their spores, such as the δ-endotoxin, Cry. The Cry toxins exhibit activity against different insect orders, such as Coleoptera, Diptera, Hymenoptera, Hemiptera and Lepidoptera. Such proteins are highly specific, which means, they are harmless to most organisms. This fact justifies their use in agriculture. Nowadays, there are over 114 million hectares of GM crops and 37% express traits of insecticidal proteins of B. thuringiensis. Since genetically modified organisms (GMOs) are becoming increasingly prevalent, several international organizations have given guidelines to investigate the safety of food derived from GMOs. This work aimed to evaluate the acute toxicity of the entomotoxin Cry1Ac in rats through classical in vivo analyzes associated with proteomic study by two-dimensional electrophoresis and shotgum proteomic technique (gel-free). Toxicity tests were conducted according to the protocol of 425 "Organization of Economic Cooperation and Development" - OECD and no deaths or signs of toxicity were observed. The gel-based proteomic analysis showed four differentially expressed proteins: Serpin α-1, Serpin A3K, Kininogen and Complement C3. These proteins expressions were reduced for the group treated with the Cry1Ac toxin. In gel-free approach, seven differentially expressed proteins were identified. Among them, factor I, H3 trypsin inhibitor, plasminogen, serpin A6, albumin, and protein resistant to oxidation showed a higher expression in animals treated with Cry1Ac, while the prothrombin expression was reduced in animals treated with the same protein. Such molecules are important for hemostasis and immune system, and may interfere with the inflammatory process, activation of the complement pathway and the coagulation cascade. Despite the physiological changes caused by Cry1Ac, this protein is still considered safe since these changes occurred at the highest dose recommended by OECD (2000 mg / kg) and without causing death of the animals.

O conhecimento do comportamento de animais selvagens em vida livre é essencial para se poder comparar com o de animais selvagens em cativeiro. A avaliação CAP (Conhecimento, Atitudes e Práticas) de visitantes e funcionários de um zoo são importantes, na medida que permitem detetar aspetos que impactam negativamente o bem-estar dos animais e dos seres humanos que com eles contactam, permitindo corrigi-los posteriormente. Durante o estudo no Monte Selvagem foram aplicados questionários tanto a visitantes como trabalhadores, tendo-se observado a atitude de visitantes e funcionários no seu relacionamento com os animais. Com o fim de avaliar a exposição a vetores de doenças zoonóticas, foram recolhidos mosquitos e carraças, potenciais transmissores de agentes zoonóticos. Os resultados deste estudo sugerem que tanto visitantes como funcionários possuem algum conhecimento sobre zoonoses e os seus modos de transmissão. Concluiu-se que há condições para o desenvolvimento dos mosquitos no parque mas pouca exposição a ixodídeos; ABSTRACT: Knowing the behavior of free-range wild animals is essential to compare it with that of captive wildlife in zoos. The KAP (Knowledge, Attitude and Practices) assessment of zoo visitors and staff is important, as it allows the detection of aspects that negatively impact the welfare of animals and humans that contact them, allowing the KAP to be corrected afterwards. During the study at Monte Selvagem, questionnaires were applied to both visitors and workers, and the attitude of visitors and employees in their relationship with animals was observed. In order to assess exposure to vectors of zoonotic diseases, mosquitoes and ticks, potential transmitters of zoonotic agents, were collected. The findings of this study suggest that both visitors and employees have some knowledge about zoonoses and their modes of transmission. It was concluded that there are conditions for the development of mosquitoes in the park but little exposure to ticks.