November 14, 2002 -- The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS), in close coordination with the Food and Drug Administration is investigating ProdiGene, Inc., of College Station, TX, for violations of the Plant Protection Act. During a compliance inspection in October 2002, APHIS found potential permit violations by ProdiGene at a site in Nebraska that had been used for small-scale field testing of corn genetically engineered to produce pharmaceutical substances in 2001.

APHIS discovered tasseled volunteer corn plants growing in a soybean field that stands on the site of the 2001 field test. The presence of these plants was a violation of permit conditions. Following this discovery, APHIS instructed ProdiGene to remove the volunteer corn plants from the field, despite the fact that the corn plants did not have viable seed. However, the soybeans were harvested before all of the tasseled corn was removed. APHIS immediately placed a hold on the soybeans that were located at a single storage facility in Nebraska so that these materials would not enter the human or animal food chains.

APHIS also discovered possible permit violations at a ProdiGene 2001 test site in Iowa in September 2002. Volunteer tasseled corn plants were found growing in a soybean field and in a pile of volunteer corn plants removed from the field earlier in the season - both of which did not comply with permit conditions. At APHIS' request, and under APHIS supervision, ProdiGene has harvested and destroyed by incineration 155 acres of corn surrounding the field test site.

At the conclusion of the ongoing investigation into ProdiGene's regulatory permit compliance APHIS, in coordination with the FDA, will determine the appropriate enforcement action against ProdiGene.

"We are thankful that the inadvertent harvesting and distribution of an unapproved, experimental corn was stopped before it threatened the integrity of the food supply with the introduction of non-food substances deliberately produced in this crop," says John R. Cady, president and CEO of the
National Food Processors Association. "However, it is nothing short of alarming to know that at the earliest stages of the development of crops for plant-made pharmaceuticals, the most basic preventive measures were not faithfully observed. This apparent violation of rules intended to control the unauthorized spread of these substances very nearly placed the integrity of the food supply in jeopardy.

"For this reason, NFPA supports mandatory regulatory oversight to prevent contamination and adulteration of the food supply with plant-made pharmaceuticals and industrial compounds that are not approved as human food or animal feed ingredients. We believe the U.S. Department of Agriculture and Food and Drug Administration should impose a stringent and mandatory regulatory framework to ensure protection of the U.S. food supply and U.S. food exports from any inadvertent or even intentional contamination by plant-made materials that have not been approved for human food and animal feed purposes."

But the action taken by APHIS proves the regulatory process is working, says Dwain Ford, president of the American Soybean Growers Association. "ASA is pleased that USDA's regulatory and monitoring procedures prevented the affected soybeans from moving beyond the single elevator where they were first stored, and that all soybeans that may have been commingled with the ProdiGene corn product will be destroyed," Ford says.

"It is very unfortunate that any company would allow an infraction of this magnitude to occur," says Leon Corzine, chairman of the National Corn Growers Assocation (NCGA) Biotech Working Group. "NCGA has had numerous meetings with every company producing these proteins, including ProdiGene. NCGA supports using all scientific, management, and mechanical measures available to eliminate the potential for such occurrences."

"Plant-made pharmaceuticals offer tremendous benefits in preventing and treating diseases," says Bob Stallman, president of the American Farm Bureau Federation. "It is imperative, however, that these opportunities not be jeopardized by failure to adhere to regulations. We believe this strong enforcement action by APHIS should boost consumer confidence and ensure the stability of foreign as well as domestic markets."