<p>Canadas regulatory system is science-based and relies on risk assessment to inform decisions about which products of biotechnology (and other technologies) are safe enough for commercial application. Since regulation involves the loss of certain liberties, it is imperative that any regulatory regime be as objective as possible. Scientific risk assessment seems to be a good way to produce the information, which guides policy makers since it involves quantitative analysis and the production of seemingly objective data.</p><p>The view adopted by regulators and in current risk assessment practices is that objective means value-free. Therefore, because risk assessment data is scientific it is thought to be value-free but this is not the case. Risk assessment necessarily involves value assumptions. Assumptions must be made at all stages of the production of risk data. This does not mean, however, that risk assessment is hopelessly subjective. The notion of value-free objectivity can be replaced with the view that genuine objectivity arises through peer review and social discourse. Regulators can adopt this understanding of objectivity to acknowledge the value-ladenness of risk assessment data.</p><p>At present, the value assumptions made by industry, government and private scientists during risk assessment go largely unnoticed yet have an effect on the outcome of regulatory decisions. Such assumptions must be recognized in order to ensure that the decisions made about the risks society face are not biased. This is particularly true in the case of biotechnology regulation. The development of the science of biotechnology has occurred concurrently with the development of the biotech industry creating the opportunity for industry-biased risk assessments.</p><p>It is possible to make changes to the existing regulatory regime in Canada in order to avoid some of the major problems associated with unrecognized value assumptions in risk assessment. A complete restructuring of the regime is unnecessary, however. Maintaining the current regulatory structure with some minor changes could address these problems. These changes include: creating an independent review board, making explicit that value assumptions are part of risk assessment in government advisory reports, and enhancing the role of regulators. Canadas regulatory system can better address the risks associated with biotechnology if it acknowledges that risk assessment is value-laden.</p>

"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.

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)"

The aim of the thesis is to evaluate control activities of selected supervisory authorities in a sphere of consumer protection and to find the opinions and attitudes of selected business entities on supervisory authorities' activities. The thesis includes a questionnaire survey among consumers and controlled in-depth interviews both with business entities and with supervisory authorities. The questionnaire survey confirms or rejects hypotheses of the thesis. Controlled in-depth interviews with selected supervisory authorities focused on their controlling activities. Managed in-depth interviews with business entities aimed to find out their views and attitudes towards supervisory authorities, as well as to identify a scope and a process of controls carried out by supervisory authorities. The thesis further outline how the selected supervisory authorities could evaluate their work with consumers. Changes are mainly concerned with informing consumers of suitable and unsuitable business premises.

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / In Brazil, the good practices in food handling are not yet fully widespread in Food Services, even though it has been a mandatory program for more than a decade. In hotels, this scenario is not different, on the organization of events worldwide increased the concern of the Ministry of Tourism, regarding the quality of food served to tourists, both sensory, as sanitary conditions, the latter being considered the most critical, because it is associated with health, and could jeopardize the country's image abroad in the event of an outbreak of Foodborne Disease. In this scenario raised a concern in the diagnosis of the implementation of the Good Practices, as well as forms of adequacy of the hotels. The aim of this thesis, it was perform the diagnosis of the food and beverage area of hotels, evaluated the interference of outsourced professional trained in food safety in the adequacy of the procedures and verify the costs associated with the implementation and maintenance of the Good Practices. As a result it was found that the food and beverage area of hotels were classified with low hygienic-sanitary level in the first evaluation. In the second evaluation it was found that the establishments with outsourced professional monitoring showed significant improvements over the implementation of the Good Practices, while establishments unaccompanied only showed improvements, but not significant. The establishments that had outsourced professional monitoring presented data related to the cost of implementation and maintenance of the Good Practices, demonstrating that the greater the investment, the greater the percentage of adaptation will be, however these costs are not as high taking into consideration the quantity of public served. / No Brasil, as Boas Práticas na manipulação dos alimentos ainda não estão totalmente difundidas nos Serviços de Alimentação, mesmo sendo mandatórias a mais de uma década. Em hotéis este cenário não é diferente, diante da realização de eventos em nível mundial cresceu a preocupação do Ministério do Turismo, com relação a qualidade dos alimentos servidos aos turistas, tanto sensorial, quanto higiênico-sanitária, sendo esta considerada a mais crítica, pois esta associada a saúde das pessoas, e pode colocar em risco a imagem do país no exterior no caso de um surto por Doença Transmitida por Alimentos. Neste cenário surgiu a preocupação no diagnóstico e implementação das Boas Práticas, assim como a necessidade da adequação dos hotéis. O objetivo desta tese foi realizar o diagnóstico da área de alimentos e bebidas de hotéis, avaliar a interferência de profissional terceirizado capacitado em segurança de alimentos na adequação dos procedimentos, assim como os custos inerentes a implementação e manutenção das Boas Práticas. Como resultado verificou-se que a área de alimentos e bebidas dos hotéis foram classificadas com baixo nível higiênico-sanitário na primeira avaliação. Na segunda avaliação os estabelecimentos com acompanhamento de profissional terceirizado apresentaram melhorias significativas em relação a Implementação das Boas Práticas, enquanto os estabelecimentos sem acompanhamento apenas apresentaram melhorias, porém não significativas. Os estabelecimentos que tiveram o acompanhamento de profissional terceirizado apresentaram dados relativos ao custo da implementação e manutenção das Boas Práticas, demonstrando que quanto maior o investimento, maiores os percentuais de adequação atingidos, porém que estes custos não são tão elevados levando-se em consideração a quantidade de público atendido.