<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>

<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)"