Regulation of Transgenic Crops Intended for Pharmaceutical and Industrial Uses

Abstract

The most interesting case in regulation of non-food agricultural biotechnology products is the manufacture of novel pharmaceutical and industrial products. The current regulatory situation in the United States has arisen out of a political economy driven largely by the food industry’s risk exposure. Yet, the resulting “zero tolerance” regulatory situation appears inefficient and unstable: set up for another incident such as befell Aventis and ProdiGene. The regulatory situation could be resolved by taking dissemination and susceptibility characteristics into account in setting containment requirements, including threshold allowances in the case of minor breaches of containment. A workable regulatory regime will need to be driven by major agricultural states’ political interests, along with the biotechnology and pharmaceutical industries, and mindful of the interests of the food industry. Countries intent on developing their domestic biotechnology industry might attract investment by providing a workable regulatory regime that ensures lower risk at lower cost.