Regulation of GMOs

A large number of organizations and individuals have expressed concerns about the potential environmental impacts of genetically modified organisms (GMOs). In terms of regulatory issues, concerns relate to the need to consider indirect and cumulative effects of GM crops (in particular their use in conjunction with chemicals), the possibility of gene transfer from GM crops to wild relatives and 'contamination' through cross pollination of non-GM crops by GM crops (Hill, 1998).

The basis for environmental safety of genetically modified organisms in the USA and Europe is one of 'substantial equivalence', where the novel product is compared to a closely related product that has an accepted standard of safety (WHO, 1991, 1995; OECD, 1993; FAO/WHO, 1996). The assessment occurs in two steps, the first being agronomic characteristics and the composition of the novel product and of the traditional counterpart are compared to assess equivalence within the limits of natural variation. Secondly, the introduced change is characterized and assessed to ensure there is no harm to human health and the environment (König, 1998). This process involves a molecular characterization and safety assessment of the introduced proteins.

The regulatory system for GMOs in the USA is under the overall guidance of the EPA through the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the USDA regulate import, movement, field trials and commercial release of GMOs under the Federal Plant Pest Act and the Plant Quarantine Act, administered by the Animal and Plant Health Inspection Service (APHIS). In Europe, the European Union implemented Directive 90/220/EEC in 1990 deals with the release and commercialization of GMOs. The Directive outlines the procedures for environmental safety evaluations for Europe, but approvals for field trials are issued by national authorities. However, approval for commercialization of a GMO product can only be gained by a complex authorization procedure in which all EU member states participate (Landsmann, 1998). This process is inevitably time consuming so that in Europe it can take between 17 months and two years to gain product approval compared to the USA where the whole process takes on average 5 months (König, 1998). The biotechnology industry consider that GMOs represent new hope for feeding the world's growing population (Stübler and Kern, 1998). The extent to which the industry is allowed to meet that goal will depend on convincing the regulatory authorities that their products indeed offer a safe, low risk opportunity for invigorating agricultural production and crop protection.

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