CRG's Official Statement on Biopharmaceutical Crops

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On November 12, newspapers across the United States reported that the Food and Drug Administration (FDA) had ordered the destruction of 500,000 biopharmaceutically contaminated bushels of Nebraska soybeans. One day later, the United States Department of Agriculture (USDA) admitted to destroying, without informing the public, 155 acres of similarly contaminated Iowa soybean fields in September.

These events thrust biopharming, a process by which plants are genetically modified to produce pharmaceutical or industrial substances and harvested, into the public spotlight. Long known mostly to industry insiders, who see it as the future of biotechnological agriculture, and activists alarmed by the industry's secretive, poorly regulated practices, biopharming has clearly become an issue of serious public concern.

Over three hundred USDA-approved open-field trials of biopharmaceutical crops have been conducted in dozens of states across the nation. These crops are often wholly experimental, producing substances not yet been approved for human exposure, much less consumption; nevertheless, the USDA rarely visits trial sites more than once, and sometimes not at all. They have asked biopharmaceutical companies to voluntarily comply with regulations — a risky proposition in any situation, and completely unacceptable in one with such potentially dire consequences. Moreover, because of the companies' desire to protect "confidential business information," total secrecy is the norm; crops are unidentified, unsecured, and uncontained, camouflaged by their anonymity.

The soybeans in Nebraska and Iowa were contaminated with a biopharmaceutical corn engineered by ProdiGene, a Texas-based corporation whose vice president of product development once boasted of a vaccine-producing corn that it was "right by the interstate, and no on could ever have seen it." The USDA previously denied Freedom of Information Act requests for documentation of ProdiGene's trials, but it is known that they are experimenting with a number of substances — including a blood clotter, an AIDS vaccine, a digestive enzyme, and an industrial adhesive — associated with severely adverse health effects. The FDA has refused to identify the contaminating substance, saying only that it is a "genetically modified material" not yet been approved for human testing.

Although the FDA and USDA managed to contain the spread of ProdiGene's corn, their public response betrayed a failure to understand the gravity of the situation. Though the "genetically modified material" was only a step away from entering the nation's food supply, one senior USDA official merely stated that "the department may consider revising its rules to lessen the chance of similar problems in the future." Meanwhile, the Biotech Industry Organization (BIO) has endorsed a moratorium on the open-field testing of biopharmaceutical corn in the nation's agricultural heartland, while the traditionally pro-biotech food processing industry, fearful of losing export markets, has proposed the restriction of biopharmaceuticals to non-food crops such as tobacco. Neither of these measures is sufficient to address the enormous scope of current industry and regulatory irresponsibility.

Because the public will bear the true costs of mistakes made with biopharmaceutical crops, they have a right to know exactly what is being done and to demand its effective regulation. Until the USDA has publicly documented every single biopharm trial in the nation, developed a system to guarantee the containment of genetically modified crops, and worked with the FDA to create a strong, enforceable, regulatory framework, the Council for Responsible Genetics calls for a total moratorium on all open-field biopharmaceutical trials. Furthermore, the open-field testing of plants which produce unapproved substances should be permanently banned.

The contaminations in Nebraska and Iowa are a clear warning. Unless the biopharmaceutical industry is curbed, it is only a matter of time before people are hurt. No commercial gain is worth the risk that is now being taken, without our permission, with us.