USDA Regulation of Pharma Crops

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Services (APHIS) regulates GM crops under the Plant Protection Act of 2000. The Act defines “plant pests” as organisms that cause disease, injury, or damage to plants or plant products, including viruses, bacteria, fungi, and parasitic plants. GM plants are regulated under the Plant Protection Act if they were created through gene transfer with Agrobacterium tumefaciens, which is considered a plant pest, or if they incorporate DNA from a plant pest (such as a terminator gene).

USDA regulates GM plants either under a permit or a notification process. For simple field trials of a Bt crop, such as Bt corn, the notification process is used, which is usually a formality. The company gives APHIS notice of the trial and agrees to follow certain rules, and USDA usually signs off. In contrast, field trials of GM crops that entail a higher risk, such as those that are highly outcrossing or that remain in the ground for a long time, require a permit. For field trials of GM crops that produce pharmaceutical or industrial chemicals, a permit is always required. The permitting process is more or less extensive, requiring either an Environmental Assessment or an Environmental Impact Statement.

When a company decides that it wants to commercialize a GM crop and produce seed for farmers to grow, it can petition APHIS for deregulated status. This process requires submitting risk-assessment data to demonstrate that the crop does not pose a plant-pest risk. The relevant data must be made public and include susceptibility to disease and insect pests, weediness, effects on non-target organisms and beneficial organisms, and the risk of gene flow to wild or weedy relatives. After the 2000 ProdiGene incident, USDA adopted the policy that pharma crops entail inherent risks and hence require a higher level of scrutiny than other GM crops. As a result, pharma crops are not eligible for deregulated status but must remain under permit even at the commercial stage.

Even so, a number of gaps remain. The current USDA regulatory system does not ensure an in-depth environmental impact assessment before pharma crops are planted. Instead, USDA’s gene-confinement measures are designed to “minimize” rather than prevent the contamination of non-GM crops. In practice, USDA is too understaffed to exercise sufficient oversight and largely leaves biotech companies to regulate themselves. Moreover, USDA keeps the locations of all test fields secret from neighboring farmers and the public, does not disclose the identity of the drug or chemical being produced, and condones biotech companies’ practice of planting pharma crops anonymously, without identification.10