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Abstract

The regulation of genetically modified food pursuant to statutes enacted decades prior to the advent of biotechnology has created a regulatory system that unnecessarily exposes society and the environment to adverse risks of biotechnology and introduces numerous inefficiencies into the regulatory system. These risks and inefficiencies include gaps in regulation, duplicative and inconsistent regulation, unnecessary regulatory expense, agencies acting outside their areas of expertise, and unnecessary increases in the cost of and delay in the development and commercialization of new biotechnology products. This Article details how to achieve a comprehensive, efficient, and scientifically rigorous regulatory system for genetically modified food. Ignoring many details, the solutions can be summarized in two categories. First, statutory and regulatory gaps that are identified must be closed with new legislation and regulation. Second, regulation of genetically modified food must be shifted from a haphazard model based on statutes not intended to cover biotechnology to a system based upon agency expertise in handling particular types of risks.

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