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
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