The Prodigene Incident
A few agricultural biotech firms have been fined for violating research protocols designed to prevent pharma crops from contaminating the food supply. USDA rules state that if one grows a pharma crop one year, the field must be left fallow for a year to prevent unharvested GM plants from commingling with the next crop.
In 2002, for example, the biotech company ProdiGene was involved in two contamination incidents. The company conducted field trials in Nebraska in which it produced avidin (a diagnostic protein) in GM corn. After the pharma crop was grown and harvested, some of the unharvested corn kernels fell on the ground. The field was then replanted with soybeans and some of the leftover kernels of GM corn germinated to produce plants called “volunteers.” When the soybeans were harvested mechanically, the bits of pharma corn, totaling a fraction of a bushel, became commingled with the beans. Because USDA has a zero-tolerance policy, it ordered the destruction of 500,000 bushels of soybeans intended for use in infant formula and veggie burgers. The department also fined ProdiGene $250,000 for failing to follow the conditions in the permit, and ordered the company to pay over $3 million in compensation for the quarantine and destruction of the soybean crop. ProdiGene did not properly control its volunteer sprouts and harvest the field. Thus, even if USDA develops stringent regulations for pharma crops, companies may not necessarily follow them. It appears that the potential for a small, but consequential, mistake in such large-scale agricultural productions is high. For example, in another incident in Iowa involving the same company, a field of pharma corn cross-pollinated a neighboring field. This required the destruction of 150 acres of potentially contaminated plants.7
Since the ProdiGene incident, growing public opposition to the production of drugs and chemicals in food and feed crops has led to stronger regulation and reduced the number of biotech companies working in the field. Permits issued by the U.S. Department of Agriculture for field trials of pharma crops dropped sharply after 2000. Large agricultural biotechnology companies such as Monsanto have decided not to invest in biopharming, and the field is now mainly limited to biotech start-ups and academic researchers.
Critics argue that only plant species not consumed by humans or livestock should be used for the production of pharmaceuticals. At present, the U.S. government is trying to create incentives for biopharming companies to use non-food crops, but doing so appears technically difficult and may not be worth the effort.
If a food crop is used for biopharming, there must be several redundant levels of confinement, even for field trials. Strategies for reducing the risk of inadvertent gene flow include ensuring “isolation distances” between GM and non-GM crops, imposing geographical restrictions (such as not growing pharma corn in parts of the country where commodity corn is grown), physical barriers to cross-fertilization (such as fences or greenhouses), and biological confinement (such as rendering male plants sterile).7