O presente trabalho tem por objetivo analisar o potencial de conflito entre normas internacionais aplicáveis ao comércio transfronteiriço de alimentos transgênicos, tendo como foco as tensões entre o Protocolo de Cartagena sobre Segurança Biológica e os acordos da OMC relevantes (SPS, TBT, GATT-94 e TRIPs), assim como as fórmulas existentes para seu encaminhamento no âmbito desses acordos e da Convenção de Viena sobre Direito dos Tratados. A fim de demonstrar a complexidade do marco regulatório internacional aplicável a OGMs, são analisadas as determinações do painel da OMC na disputa relativa à moratória européia na aprovação de novos produtos biotecnológicos, com relação aos seguintes pontos: (a) aplicabilidade da Convenção sobre Diversidade Biológica, do Protocolo de Cartagena e do princípio da precaução na interpretação dos acordos abrangidos; (b) aplicação concorrente dos Acordos SPS e TBT à disputa; (c) aplicação de dispositivos excludentes do SPS. Da análise dessas determinações, pode-se depreender que o potencial de conflito entre normas internacionais aplicáveis a produtos GMs não se limita às tensões entre o Protocolo de Cartagena e os acordos da OMC, estando presente também entre esses acordos. A fim de ilustrar o paralelismo de desafios na frente multilateral e doméstica em relação à regulamentação de OGMs, parte do trabalho foi dedicada à análise de um conjunto de ações perante o Judiciário brasileiro envolvendo conflitos entre normas nacionais de distintos níveis hierárquicos aplicáveis a produtos transgênicos. Essas ações envolveram desde divergências quanto ao dispositivo constitucional aplicável para determinar a esfera de competência da União e dos Estados para legislar sobre distintos aspectos da regulamentação de OGMs até questionamentos à constitucionalidade e à legalidade de determinados diplomas legais infra-constitucionais. A crescente judicialização no Brasil dos conflitos de normas que disciplinam a liberação de produtos transgênicos ilustra as limitações do marco regulatório nacional, também presentes na frente multilateral, para acomodar satisfatoriamente os objetivos de proteção da biodiversidade e da saúde humana de um lado, e da livre comercialização de alimentos geneticamente modificados, de outro. / The main goal of this work is to analyse the potencial of conflict among international norms applicable to the transboundary trade of GMOs, taking into account the tensions between the Cartagena Protocol on Biosafety and the relevant WTO agreements (SPS, TBT, GATT-94 and TRIPs). An analysis of the conflict clauses in these agreements, as well as in the Vienna Convention on the Law of Treaties is also made. In order to demonstrate the complexity of the international GMO legal framework, this work examines the determinations of the WTO panel on the biotech case involving the delay of European regulatory authorities to approve new biotechnological products. In this analysis special attention is given to the following points: (a) applicability of the Convention on Biological Diversity, of the Cartagena Protocol and of the precautionary principle in the interpretation of the covered agreements; (b) simultaneous application of the SPS and the TBT to the dispute; (c) application of provisions of the SPS which are mutually exclusive. From the analysis of these determinations one can infer that the potential of conflict among international norms applicable to GMO products is not limited to existing tensions between the Protocol and WTO agreements, but is also present among the latter agreements. In order to demonstrate the coincidence of challenges involved in the regulation of GMOs at the multilateral as well as at the domestic level, part of this work was dedicated to the analysis of a set of claims before the Brazilian courts involving conflicts of norms of different hierarchical status applicable to GMOs. These claims comprised divergent opinions regarding which constitutional provision should be applicable in order to define Federal and State Government´s respective competence to legislate on different aspects of GMOs regulation. These claims also involved direct attacks on the constitutionality and legality of some infra-constitutional norms. The growing judicialization of conflicts of norms that govern the release of genetically modified products illustrates some of the shortcomings of Brazil´s domestic legal framework - that also exist at the multilateral level - that doesn´t allow a mutually satisfactory accomodation between the goals of protection of biodiversity and human health on the hand and the free trade of GMOs on the other hand.

Algodão geneticamente modificado que expressa a toxina Cry1Ac de Bacillus thuringiensis Berliner tem sido plantado no Brasil desde 2006. Entre as pragas-alvo da tecnologia, Alabama argillacea (Hüeb.) é uma espécie monófoga e apresenta alto potencial de risco de evolução da resistência. Para a implantação de um programa de manejo da resistência de A. argillacea à toxina Cry1Ac no Brasil, os principais objetivos do trabalho foram: a) estabelecer a linhas-básicas de suscetibilidade à toxina Cry1Ac em populações de A. argillacea e definir concentrações diagnósticas para o monitoramento da resistência e b) isolar e caracterizar locos microssatélites para avaliar a variabilidade e estruturação genética de populações de A. argillacea no Brasil. As linhas-básicas de suscetibilidade foram estimadas por meio de bioensaio de imersão de discos de folhas em soluções contendo a toxina Cry1Ac para populações de A. argillacea coletadas nos estados da Bahia, Goiás, Mato Grosso e Mato Grosso do Sul, durante as safras agrícolas de 2008 e 2009. Foram isolados e caracterizados dez locos microssatélites. Para avaliar a variabilidade genética foram estimadas as heterozigosidades observadas e esperadas. Para o estudo da estruturação genética foram estimadas as estatísticas F e feita a análise de agrupamento (distância de Nei) e análise Bayesiana. Baseado na estimativa da CL50 foram encontradas variações naturais de até seis vezes na suscetibilidade à toxina Cry1Ac entre as populações testadas. A partir da análise conjunta dos dados de concentração-mortalidade das populações testadas, foram definidas as concentrações diagnósticas de 10 e 32 µg de Cry1Ac/ml de água para futuros programas de monitoramento da resistência. O número médio de alelos por loco foi de 7,1 (variando de dois a 23 alelos). As heterozigosidades observada e esperada médias foram de 0,532 e 0,329. O índice de fixação intrapopulacional médio (f FIS) foi de 0,268, com variação entre os locos de -0,008 a 0,736. O índice de fixação da espécie (FIS) estimado através da análise de variância foi de 0,244 (IC 95% de 0,093 a 0,418). O valor de FST estimado foi de 0,036 (IC 95% de 0,007 a 0,080). Esse valor de FST não diferiu significativamente de zero, indicando a ausência de estruturação genética. Contudo foi detectado certo grau de endogamia intrapopulacional. A estruturação espacial da variabilidade genética não foi detectada, pois as populações avaliadas apresentaram uma coesão que é mantida pela alta taxa de migração (6,7 migrantes por geração). Entretanto, foi identificada indícios de estruturação genética determinada pelo tempo, uma vez que tanto o agrupamento baseado em distâncias genéticas quanto à análise Bayesiana identificaram grupos que são formados por populações coletadas em safras agrícolas diferentes. As causas ligadas a essa mudança na variabilidade genética não puderam ser identificadas, entretanto pode se inferir que possivelmente causas naturais ou práticas de manejo estejam determinando eventos de gargalo genético. Devido ao intenso fluxo gênico entre populações de A. argillacea no Brasil, estratégias de manejo da resistência devem ser implantadas no âmbito nacional. / Genetically modified cotton expressing Cry1Ac toxin of Bacillus thuringiensis Berliner has been planted in Brazil since 2006. Among target pests of this technology, Alabama argillacea (Hüeb.) is a monophagous species and offers a high potential risk of resistance evolution. In order to implement a resistance management program of A. argillacea to Cry1Ac toxin in Brazil, the objectives of this research were: a) to establish baseline susceptibility to Cry1Ac toxin in A. argillacea populations and define diagnostic concentrations for resistance monitoring and b) to isolate and characterize microsatellite loci to evaluate the variability and genetic structure of A. argillacea populations in Brazil. The baseline susceptibility data were estimated with leaf-disc bioassays by dipping into different concentration of Cry1Ac solution. Populations of A. argillacea were collected in Bahia, Goiás, Mato Grosso and Mato Grosso do Sul States, during 2008 and 2009 cotton-growing seasons. Ten microsatellite loci were isolated and characterized. The genetic variability was evaluated estimating observed and expected heterozygosities. For the studied of genetic structure, the F statistics was estimated, and Cluster analysis (Nei´s distance) and Bayesian analysis were performed. Based on estimation of LC50, natural variation up to 6-fold was detected in the susceptibility to Cry1Ac among tested populations. Based on analysis of concentration-mortality data by combining all populations, diagnostic concentrations of 10 and 32 µg of Cry1Ac/ml of water were defined for monitoring resistance. The mean number of alleles per loci was 7.1 (varying from 2 to 23 alleles). The observed and expected heterozigosities was 0,523 e 0, 395. The mean intrapopulation fixation index (f FIS) 0,268, varying from -0.008 to 0.736 between loci. The species fixation index (FIS) estimated by analysis of variance was 0.244(95% CI of 0.093 to 0.418). The estimated value of FST was 0.036 (95% CI of 0.007 to 0.080). The FST value was not significantly different from zero, indicating absence of genetic structure However, some degree of intrapopulational inbreeding was detected. Spatial structure of genetic variability was not detected because tested populations showed cohesion kept by high migration rate (6.7 migrants per generation). However, evidence of genetic structure across time was detected by Cluster analysis of genetic distance as well as by Bayesian analysis with group formation by population collection seasons. Factors affecting changes in genetic variability were not identified; however, natural factors or management practices may be determining some genetic bottleneck events. Due to intense gene flow among A. argillacea populations in Brazil, resistance management strategies must be implemented in a national basis.

Os panoramas social e ambiental estão intimamente relacionados, o que atrai a perspectiva socioambiental. Assim, as interferências nas condições de vida da população proporcionadas pela biotecnologia são compreendidas na proteção ao meio ambiente. A comercialização de organismos geneticamente modificados em alimentos gera muito debate doutrinário e científico na atualidade. No entanto, já é possível revelar alguns mitos e efetivar algumas constatações acerca do tema. Os mitos trazem as promessas de buscar saciar a fome através do aumento da produção com a utilização da biotecnologia na área alimentar, bem como a prioridade na produção de alimentos com propriedades benéficas para a saúde da população. As constatações esbarram em alguns episódios negativos envolvendo a utilização de organismos geneticamente modificados e, também, no forte domínio de grandes corporações, que estão ditando as regras do desenvolvimento biotecnológico. Diante deste quadro, na comercialização dos alimentos, a disponibilização de informações através da rotulagem ganha destaque, sendo importante analisar o tratamento legal que vem sendo dado no âmbito interno, na União Européia, sob a perspectiva dos Estados Unidos e do Codex Alimentarius. Diante do contexto legal, resta claro que ainda existem diversas polêmicas e que a disponibilização de informações ainda encontra alguns desafios, em especial, na fiscalização da rotulagem e na conciliação da informação com a diversidade cultural. Para que a informação tenha plena concretização deve estar inter-relacionada com a educação e a participação dos atores envolvidos. / The social and environmental views are closely related, which attracts the socioenvironmental perspective. All artifacts in the living conditions of the population is comprised of biotechnology in environmental protection. The commercialization of genetically modified organisms in food generates much debate and scientific doctrine today. However, it is possible to draw some myths and commit some observations on the subject. Myths bring the promises of seeking satisfying hunger by increasing production with the use of biotechnology in the food, as well as the priority in food production with properties beneficial to health. The findings run into some negative episodes involving the use of genetically modified organisms and also strong in the domain of large corporations that are dictating the rules of biotechnology development. This picture, in the marketing of food, the availability of information through labeling is emphasized, it is important to consider the legal treatment that has been given at the domestic, European Union, from the perspective of the United States and the Codex Alimentarius. Given the legal context, it remains clear that there are still many controversies and the availability of information is still some challenges, particularly in reviewing the labeling and reconciliation of information about cultural diversity. For information to have full effect should be inter-related education and participation of stakeholders.

1 Selected issues of legal regulation of genetically modified organisms Abstract Genetically modified organisms are one of the most pressing challenges of modern agriculture and other economic sectors. This is due to the large number of potential benefits and risks, which are quite often insufficiently scientifically researched, exacerbating the controversy associated with their use. It is a technology that has been used for a relatively long time, but its legal regulation is constantly challenged due to the dynamic development of the related scientific advances. Despite the aforementioned, some issues of the topic receive only marginal attention, which makes it difficult to create and apply a fully functioning legal regulation. The diploma thesis itself deals with selected issues of legal regulation of genetically modified organisms, focusing on the readiness of legal regulation, functionality of auxiliary instruments, as well as de lege ferenda considerations. These topics are formulated into three basic research questions, which the author tries to answer by analyzing relevant parts of the legal regulation. The aim of this thesis is to expand this vital part of environmental law with new findings and thus supplement other academic works that deal with legal regulation of genetically modified organisms....

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This thesis addresses the puzzle of variation in first-generation regulatory policies for controversial science and technology, as demonstrated in the cases of agricultural genetically modified organisms (GMOs) and human embryonic stem cell research in the United Kingdom and the United States. Why did policy outcomes vary in each technology case? This study answers this question by placing greater emphasis on institutional factors. Although works within institutional analysis, bureaucracy and regulation literatures make significant progress in revealing how existing institutions can shape outcomes, how far one can characterize bureaucratic behavior and whether interest groups capture regulation, they nevertheless create an opening for research that: describes a mechanism for path dependence to explain variation in policies; shows the degree to which bureaucratic behaviors can influence outcomes; and, highlights instances in which regulatory officials hold power. This thesis makes an original contribution by providing new historical details relating to these cases, and by providing an extensive elaboration of Pierson’s criteria for increasing returns and a so-called secondary test of path dependence to explain outcomes. The study recounts the biography of key policy documents in each case by tracing the process of decision-making through government and archival sources, secondary literature and more than 40 elite interviews. In doing so, it details the activities of key governmental bodies within the European Union, UK and US. Moreover, it shows how the Coordinated Framework (1986) and Human Fertilisation and Embryology Act 1990 framework represented decision-making structures which triggered changes in actors and interests and shaped permissive outcomes for GMOs and stem cell research in the US and UK, respectively. Furthermore, lack of comparable structures may help account for restrictive policies for GMOs in Europe and the UK, and for stem cell research in the US.

"Mémoire présenté à la Faculté des études supérieures en vue de l'obtention du grade de Maître en droit (LL.M)" / Depuis quelques années, le recours à la biotechnologie dans le secteur de l'alimentation est omniprésent. Les techniques, évoluant au gré de l'avancement de la science, permettent aux gens faisant partie de plusieurs sphères de la société, tels les scientifiques, producteurs, agriculteurs, consommateurs etc., de profiter de ces percées technologiques. Toutefois, afin d'encadrer la commercialisation de ces nouveaux produits alimentaires découlant de cette technologie, un cadre réglementaire devait, il va sans dire, être élaboré. Ce fut le cas de part et d'autre de l'Atlantique. Toutefois, bien qu'appréciée des scientifiques, cette technologie est loin de faire l'assentiment de tous. D'ailleurs, différentes perceptions se reflètent dans les différents cadres réglementaires mis de l'avant, tout aussi bien canadien que français, quant à l'utilisation et la mise en vente des nouveaux aliments. Ce travail décrit les systèmes réglementaires visant la commercialisation des aliments nouveaux tant canadien que français. Par ailleurs, il relate les différents débats, sociologique, éthique, et techniques, dont ces organismes génétiquement modifiés (OGM) sont la cible. / Since the past decades, the use of biotechnology in the industry of novel food was very considerable. This new technique is very useful, and can be easily important for an appreciable quantity of people, like productors, agricultors and consumers. Since it was used in the production of novel food, a new regulatory enforcement was needed. It was done either in France and Canada, but differently. As we know, the different way of life in both countries play an important role in the acceptance of the genetically modified organisms (GMO's). In this thesis, we will give a description of the different regulatory frameworks for food products of biotechnology. Then, we will see what was important, according to the different sociologie and ethics point of view, in the elaboration of these relevant legislation.

O melhoramento genético clássico de sementes milho (Zea mays L.) permitiu desenvolver inúmeras variedades, incluindo o milho com qualidade proteica melhorada (Quality Protein Maize, QPM), que visava aumentar os teores proteicos e as propriedades nutricionais. Por outro lado, novas variedades comerciais foram obtidas por vegetais geneticamente modificados (GM), com foco em parâmetros agronômicos. Em ambos os casos, a segurança dessas variedades para uso como alimento é uma das principais preocupações dos desenvolvedores e dos órgãos de regulamentação. A Equivalência Substancial é a base do sistema de avaliação da segurança de culturas geneticamente modificadas, no entanto alterações na expressão de proteínas não são devidamente analisadas e esclarecidas. As abordagens proteômicas complementam as técnicas de avaliação de biossegurança para alimentos GM, bem como permitem investigar possíveis efeitos indesejáveis derivados do melhoramento clássico. Os objetivos do presente estudo foram caracterizar e comparar os perfis proteicos de variedades de milhos convencionais melhorados (QPM) e geneticamente modificados (GMs), contra suas respectivas linhas convencionais utilizando técnicas proteômicas como eletroforese bidimensional (2-DE) e bottom up shotgun (gel-free). Num primeiro estudo, foram utilizadas três amostras de milho, sendo duas variedades convencionais com QPM (QP1 e QP2) e uma variedade convencional normal (CN). No segundo estudo, foram analisadas duas cultivares de milho GM (GM1 e GM2) e seus respectivos convencionais genitores (CG1 e CG2). As composições químicas de todas as amostras também foram avaliadas quanto a Equivalência Substancial. O extrato bruto proteico foi submetido à análise de eletroforese unidimensional (1-DE), bidimensional (2-DE) e bottom up shotgun (gel-free). As imagens dos mapas proteicos foram analisadas pelo software Image Master 2D Platinum 7.0 (GE). Os spots diferencialmente expressos e selecionados foram sequenciados por MS. Pela composição química das principais frações das amostras de milho foi possível identificar a equivalência substancial entre as amostras convencionais e GMs, bem como QPMs e sua convencional dentro das faixas de variabilidade esperadas da espécie. Nos géis 1-DE foram observadas bandas proteicas com perfis similares entre os grupos de amostras avaliadas para ambos estudos. Nas imagens dos géis 2-DE não houveram alterações extremas entre as amostras de milhos GMs e seus respectivos convencionais genitores (CGs), mas apenas diferenças na intensidade dos spots proteicos. As variedades QPMs e CN apresentaram diferenças devido à distribuição dos spots. Os mapas proteicos das amostras CG1 x GM1 e CG2 x GM2 apresentaram maior semelhança com porcentagens de matchings superiores a 70 %, enquanto as porcentagens de matchings entre variedades diferentes (QPMs e CN) foram menores. No total foram identificadas 219 proteínas das amostras CGs x GMs e QPMs x CN, classificadas quanto aos seus processos biológicos e função molecular. Em conclusão, foram encontradas diferenças entre os cultivares GMs e CGs, indicando uma variação normal entre variedades de milho, que não comprometem a segurança alimentar das amostras estudadas. Quanto às amostras com QPM e CN as diferenças encontradas são devido à sua distância nas linhagens ou germoplasma. / The classic genetic breeding of corn seeds (Zea mays) has enabled the development of many varieties, including corn with improved protein quality (Quality Protein Maize, QPM), which aimed to increase protein levels and nutritional properties. On the other hand, new commercial varieties have been obtained out of genetically modified (GM) vegetables, with a focus in agronomic parameters. In both cases, the safety of these varieties for food use is one of the main concerns for the developers and for the regulatory agencies. Substantial Equivalence is the basis of the safety evaluation system for genetically modified crops, however, alterations in the protein expressions are not been properly analyzed and clarified. The protein approaches complement the techniques of biosafety evaluation for GM foods, as well as allow for possible undesirable effects derived from classic improvement to be investigated. The goals of the current studies were to characterize and compare the protein profiles of the different varieties of conventionally improved (QPM) and genetically modified (GM) corn, against their respective conventional lines using proteomic techniques, such as, two-dimensional electrophoresis (2-DE), bottom up shotgun (gel-free) and masses spectrometry (MS). In a first instance of the study, three samples of corn were used, two of conventional varieties with QPM (QP1 and QP2) and one conventional normal variety (CN). In a second instance of the study, two cultures of GM corn (GM1 and GM2) were analyzed and their respective conventional genitors (CG1 and CG2). The chemical compositions of all the samples were also evaluated for their Substantial Equivalence. The protein raw extract was submitted to analysis of one-dimensional (1-DE), two-dimensional (2-DE) electrophoresis, and bottom up shotgun (gel-free). The protein image maps were analyzed by the Image Master 2D Platinum 7.0 (GE) software. The spots which were expressed and selected differentially were sequenced by MS. By the chemical composition of the main fractions of the samples of corn, it was possible to identify the substantial equivalence between the conventional samples and GMs, likewise with OPMs and their conventional in the ranges of variability which were expected for the species. On the 1-DE gel, it was observed protein bands with similar profiles amongst the groups of evaluated samples for both studies. In the images of the 2-DE gel, there were no alterations between the GM corn and their respective conventional genitors (CGs), but only differences in intensity of the protein spots. The OPM and CN varieties presented differences due to the distribution of the spots. The protein maps of samples CG1 vs. GM1 and CG2 vs. GM2 presented greater similarities with the percentages of matchings superior to 70%, while the percentage of matchings among different varieties (QPMs and CN) were smaller. In total, there were 219 proteins identified in the samples CGs vs. GMs and QPMs vs. CN, classified by the biologic processes and molecular function. In conclusion, there were found differences between the cultures of GMs and CGs, indicating a normal variation among the corn varieties, which do not affect the food security of the studied samples. As per the samples with QPM and CN, the differences found were due to the line distances or germplasm.

[pt] O presente trabalho tem como objetivo analisar alguns aspectos concernentes às recentes inovações tecnológicas, e suas conseqüências para o meio ambiente. Embora não exista desenvolvimento social sem o progresso econômico e cientifico, não se pode conceber a existência de um Estado Democrático de Direito sem a preservação ambiental. A consolidação dos direitos e garantias fundamentais só é possível com a concretização do desenvolvimento sustentável, hoje tido como mera utopia. Como forma de mitigar as constantes agressões aos ecossistemas, estuda-se como a modernidade influencia na formação da Sociedade de Risco, marcada pela existência de graves situações que por muitas vezes passam desapercebidas, mas representam profundas ameaças para a humanidade. O projeto moderno mostra-se, hoje, como impraticável graças aos seus próprios fundamentos. Trata-se do contexto da modernização reflexiva. Acredita-se que mediante a adoção do postulado da cautela, concretizada pelo princípio da precaução, estar-se-á dando um importante passo para o controle dos riscos existentes. O Brasil enfrenta no presente momento tais questões, dada a necessidade de regulamentação da produção e consumo dos organismos geneticamente modificados, também conhecidos como alimentos transgênicos. Nesse caso, o instrumento normativo que irá disciplinar o uso do princípio da precaução em nosso país pode ser um importante instrumento de defesa desta concepção democrática da interpretação da legislação ambiental, inclusive no campo da hermenêutica constitucional. / [en] This work is intended to analyze some aspects concerning the recent technological innovations, and their consequence to the ambient. Although there is no social development without economic progress, we cannot conceive the existence of a rightfull Democratic State without the preservation of the ambient. The consolidation of the rights and fundamental warranties is only possible with the concretization of sustained development, today considered as utopic. As a way to mitigate the continuous agressions to the ecosystem, we study how modernity influences the formation of the Risk Society, marked by the existance of serious situations that many times go unperceived, but represent a profound menace for humanity. The modern project seems, today, unpracticable thanks to his own foundations. It is believed that, through the adoption of a postulate of caution, concreted by the caution principle, an important step is given for the control of risks. At present, Brasil is living these questions, due to the necessity to regulate the production and use of genetically modified organisms, also known as transgenic foods. In this case, the normative instrumets that are going to disciplinate the use of the principle of caution in our country may be an important instrument of defense of this democratic conception of the interpretation of ambiental laws, inclusive in the field of democratic hermeneutic.

Depuis quelques années, le recours à la biotechnologie dans le secteur de l'alimentation est omniprésent. Les techniques, évoluant au gré de l'avancement de la science, permettent aux gens faisant partie de plusieurs sphères de la société, tels les scientifiques, producteurs, agriculteurs, consommateurs etc., de profiter de ces percées technologiques. Toutefois, afin d'encadrer la commercialisation de ces nouveaux produits alimentaires découlant de cette technologie, un cadre réglementaire devait, il va sans dire, être élaboré. Ce fut le cas de part et d'autre de l'Atlantique. Toutefois, bien qu'appréciée des scientifiques, cette technologie est loin de faire l'assentiment de tous. D'ailleurs, différentes perceptions se reflètent dans les différents cadres réglementaires mis de l'avant, tout aussi bien canadien que français, quant à l'utilisation et la mise en vente des nouveaux aliments. Ce travail décrit les systèmes réglementaires visant la commercialisation des aliments nouveaux tant canadien que français. Par ailleurs, il relate les différents débats, sociologique, éthique, et techniques, dont ces organismes génétiquement modifiés (OGM) sont la cible. / Since the past decades, the use of biotechnology in the industry of novel food was very considerable. This new technique is very useful, and can be easily important for an appreciable quantity of people, like productors, agricultors and consumers. Since it was used in the production of novel food, a new regulatory enforcement was needed. It was done either in France and Canada, but differently. As we know, the different way of life in both countries play an important role in the acceptance of the genetically modified organisms (GMO's). In this thesis, we will give a description of the different regulatory frameworks for food products of biotechnology. Then, we will see what was important, according to the different sociologie and ethics point of view, in the elaboration of these relevant legislation. / "Mémoire présenté à la Faculté des études supérieures en vue de l'obtention du grade de Maître en droit (LL.M)"