Regulating Transgenic "Pharm" Plants: Pre-Commercialization Review and Post-Commercialization Monitoring

Abstract

This manuscript presents an analysis of the regulation of transgenic plants that are engineered to express pharmaceutical or industrial products (referred to throughout as “pharm†plants). Pharm plants promise to facilitate the inexpensive production of a variety of specialty products. However, critics have questioned the adequacy of regulatory measures that are intended to safeguard the food supply and the environment. Many pharm plants express unusual products that have not previously entered the food supply, and in many instances the products are intended to have pharmacological effects in humans. The commingling of such plants with food crops could have adverse effects on the safety of the food supply. The current regulatory system relies on processes that are intended to contain the pharm plants, preventing the commingling of pharm plants or their transgenes with food crops or wild plants. A review of the literature on transgene spread, much of it garnered from field experience with the widely commercialized transgenic herbicide- and pest-resistant plants, illustrates the inadequacy of such containment methods. More effective, self-perpetuating biological containment systems exist, but at present there is no effort to gather the environmental and food safety information that would provide a rational basis for determining the appropriate level of containment. By requiring a pre-commercialization review of the environmental and food safety hazards for each new pharm plant, regulatory agencies would be able to set containment measures according to cost-benefit principles. A pre-market review system will provide sound risk predictions for food toxicity issues, but scientists’ abilities to predict environmental risks and food allergy risks are limited. A post-commercialization monitoring system should be used to facilitate the detection of and response to unforseen adverse events. By combining greater pre-commercialization review and post-commercialization monitoring, regulatory agencies can achieve a greater degree of certainty and credibility.