Safety concerns over the use of molecular biotechnology in the improvement of crops has generated substantial, heated and confusing debates, often driven by ideology and hysterics. Modification of crops is not new, and biotechnology (in its broadest sense) has been used for over a century to accelerate the development of new crops for food, feed and fibre, so as to meet the demands of a growing global community. The introduction of crops developed via molecular biotechnology [Genetically Modified Crops (GMCs)] represents the latest step in this inexorable innovative progression of technology. However, misinformed concern has led to a broad embrace of the Precautionary Principle as a regulatory paradigm for GMCs, such that research, development and deployment are delayed, hindered or outright halted. Although of possible use in limited applications, the Precautionary Principle is likely impracticable, as it posits an untenable philosophical paradox of proving the negative proposition that GMCs will never be unsafe. If such a position is accepted, then any technological process can be permanently stymied. To date, empirical observations indicate that there have been no documented problems associated with GMCs. On the contrary, all of the documented fiascos have been due to conventional ‘biotechnology’, e.g., mad cow disease, virus contaminated vaccines and the development of toxic crops via conventional plant breeding. Therefore, regulation of GMCs, whether in the United States or in Europe, should move away from a process/method focus and to a product risk/benefit analysis, that is, a case-by-case evaluation of any new organism, regardless of as to how it was developed, or (as in the case of introduced exotic plants) if it even was the product of biotechnology. A rationally based, risk assessment, risk management paradigm appears to be a far better regulatory approach, especially in the light of empirical determination of actual risks and benefits.

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Journal of Intellectual Property Rights

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