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EN
What constitutes an appropriate approach towards GMO regulation continues to be a subject of much controversy. This paper analyses the approach adopted by the United States, the global leader in the field of GMO development, commercialization, production and export. Under the 1986 US Coordinated Framework the primary responsibility to regulate biotechnology products, which includes GMO, is shared by three different federal regulatory agencies (USDA-APHIS, EPA and FDA). Each of them derives its authority from different federal statutes and focuses on different product categories. GMO have not been singled out as a separate category of products for purpose of their regulation, but fitted into existing product categories, depending on their traits and intended uses. Each of the three regulatory pathways needs therefore to be examined in detail. Further, to place the approach adopted by the US in a broader context the paper discusses the approaches adopted in several other jurisdictions, namely Canada and Argentina as well as the European Community, and seeks to compare them with the American regulatory approach. The United States, Canada and Argentina, all three being major global producers and exporters of GMO, share certain regulatory goals, concepts and principles. They base their regulatory frameworks on a premise that modern biotechnology used as a production method is not inherently risky. The similarities as well as the solutions specific to each of these countries are discussed in the paper. Finally, the American approach towards GMO regulation is contrasted with the approach of the European Community. The two approaches differ significantly and the clash between them has become evident in the international arena, most clearly within the recent WTO dispute (between the US, Canada and Argentina being on one side of the dispute and the EC - on the other). Analysis and comparison of these regulatory systems may appear to be a valuable input into the discussion on how to regulate GMO, currently taking place in many countries, also in Poland - in particular in context of the current legislative steps taken to adopt a new Polish act on GMO
EN
Division of powers between the European Community and its Member States in the field of genetically modified organisms' regulation is a complex issue, requiring a thorough analysis of primary as well as of secondary law provisions. The revision of Community legal regime on GMO has been pointed out by the Member States as the prerequisite for putting an end to the so-called 'de facto moratorium' and for overcoming the decision-making impasse with regard to placing GMO and GM products on the EC market and their use within the Community, which is particularly important having in mind the complaints filed by the United States, Canada and Argentine and the dispute settlement proceedings initiated against the European Community and its Member States at the World Trade Organisation (WTO). However, many issues have not been resolved yet and they are a subject of intense debate at various levels (regional, state and Community). Individual Member States (as well as their regions) are exploring the possibilities under the EC law to pursue their own levels of environmental and human health protection, higher than the EC level deemed appropriate in this field, and to prohibit or restrict the free circulation and use of GMO and GM products within their territory. To determine the impact which the Community legal acts referring to GMO have on Member States' powers in this area of regulation it is essential to analyse the legal basis of the mentioned acts, their objective and content, and finally - the degree and scope of harmonization achieved at the EC level. It is essential to ensure transparency and coherence in this sensitive field of regulation and to provide balance between the fundamental objectives: establishment of high level of environmental and human health protection as well as providing smooth, undistorted functioning of the EC internal market and further safe development of modern biotechnology.
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