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	special feature Pharm and Industrial Crops: The Next Wave of Agricultural Biotechnology

POLICY RECOMMENDATIONS Pharm crops should be tightly regulated to protect against their risks to human health, the food supply, and the environment. Addressing these risks is also essential to the advancement of the technology—even one discovery of a food product contaminated with engineered drugs could hobble the technology, if not stop it in its tracks.   Under the federal framework for oversight of biotechnology products, the US Department of Agriculture (USDA) and the Food and Drug Administration (FDA) have primary responsibility for regulating pharm crops. The USDA oversees the environmental phases of pharm-crop production while the FDA steps in to regulate drug production and purity, clinical testing, and commercialization. Those agencies have begun efforts to strengthen oversight of pharm crops, but it is a difficult  task. Among other challenges, the regulatory system for pharm crops, like other parts of the federal biotechnology framework, was cobbled together from statutes originally enacted for other purposes. As a result, the current system is not appropriately tailored to pharm crops and therefore does not adequately protect against their risks.  As the centerpiece of new regulation, UCS has urged the USDA and FDA to take the following steps to ensure that the food supply is completely protected against contamination from pharm crops: 1. USDA and FDA should jointly set zero contamination of the food supply as the goal of the agencies’ pharm-crop policy. Exposing consumers to drugs though food crops is an unacceptable risk to human health. In addition, the discovery of drugs in food items would cause momentous and costly disruptions in the food system. To guard against these serious consequences, USDA and FDA should work together to set zero contamination of the food supply as the goal of the agencies’ pharm-crop policy. 2. USDA and FDA should establish a public scientific advisory committee on pharm crops to consider and advise the agencies on the full range of measures available to meet the goal of zero contamination of the food supply. To determine which measures—or combination of measures—can achieve a zero-contamination goal, USDA and FDA should convene a panel of experts. The agencies should charge the committee with defining and evaluating all available measures and approaches, including at a minimum the ones listed below, for their contribution to preventing contamination of the food supply. Potential measures include: Zoning—Growing pharm crops in designated areas, perhaps states or counties, where they would not encounter food crops could prevent outcrossing and severely reduce opportunities for physical mixing. Spatial separation—If pharm plants are grown at a sufficient distance from food crops, viable pollen will not reach food crops. Temporal separation—Outcrossing can also be prevented by planting pharm and food crops so that they flower at different times. If plants do not flower in the same time period, pollen produced by the pharm plants will not encounter receptive eggs to fertilize in the food crops. Disallowing food crops—Both physical mixing and outcrossing would be substantially reduced if only nonfood (and nonfeed) crops were used for pharmaceutical production. Dedicated machinery and infrastructure—Dedicating farm machinery (planters, combines, trucks) and grain-handling infrastructure (elevators, trucks, railroad cars) solely to pharm crops would decrease the likelihood of physical mixing. Indoor production—Growing pharm crops indoors would eliminate outcrossing and, if the facilities were used solely for pharm crops, would also avoid physical mixing. Sterile pollen—Requiring that pharm crops produce sterile or no pollen would help reduce outcrossing. Engineering chloroplasts—Splicing drug genes into chloroplasts would reduce  outcrossing substantially because pollen typically contains few, if any, chloroplasts. Suicide genes—Genetic engineers may be able to devise suicide-gene cassettes that would reduce the viability of pharm-crop seeds. Although sterile, such seeds would still carry the drug products of interest and would be a food contamination problem if moved into the food system. Suicide genes would also not inhibit the expression of drug genes if transferred to neighboring crops via pollen. The USDA/FDA pharm-crop advisory committee should deliberate in public. Its members should be selected for their expertise in relevant scientific disciplines and crop production. The panel should be balanced to include representatives from academia, the food and pharm-crop industries, consumer and environmental organizations, and organic and conventional commodity crop grower groups. The committee’s report should be written by its members and made public in a timely fashion. 3. USDA and FDA should use the advisory committee’s report to devise regulatory requirements to be imposed on growers, handlers, and transporters of pharm crops. Once the government has the results of the committee’s work, it should evaluate the cost and feasibility of adopting the options or combinations of options that meet the goal of zero contamination of the food supply. Once it has selected the appropriate measures, the government should impose them as mandatory conditions on the field testing and commercial growth of pharm crops. 4. USDA and FDA should impose a moratorium on field tests and commercial production of engineered pharm crops until they have convened the scientific advisory committee and established a regime that the scientific community believes will assure the goal of zero contamination of the food supply. The pharm-crop industry is already struggling in the wake of previous contamination episodes: the StarLink Bt-corn contamination of food products in 2000 and ProdiGene Company’s mixing of pharm corn with soybeans at a grain elevator in 2002. Too much is at stake to allow more such incidents, which remain possible as long as pharm crops are grown without adequate confinement. To avoid a “StarLink with drug genes,” USDA and FDA should impose a moratorium on field tests and commercial production of engineered pharm crops. That delay should last until they have convened the scientific advisory committee and established a regime that the scientific community believes will assure the goal of zero contamination of the food supply.   next section back to the first page