WASHINGTON, DC, December 9, 2002 (ENS) - ProdiGene Inc., the company that allowed genetically engineered corn to contaminated about 500,000 bushels of soybeans, will pay a $250,000 fine - the first such penalty levied by the federal government. On Friday, the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) reached an agreement that settles violations of the Plant Protection Act (PPA) involving ProdiGene. While ProdiGene neither admitted nor denied any violations of the PPA, the company will pay a civil penalty of $250,000.
In addition, the company will reimburse the USDA for the costs of buying and incinerating tons of soybeans now stored in Nebraska, and pay to clean the facility and all its equipment.
Last month, USDA officials learned that a small amount of corn, genetically engineered to produce a protein that serves as a pig vaccine, had contaminated thousands of bushels of soybeans grown in Nebraska. The soybeans were grown in a field that had previously been used by ProdiGene to grow the engineered corn. When the corn crop failed, ProdiGene plowed it under and planted food grade soybeans.
Some corn plants came up among the soybeans, and when the field was harvested, ProdiGene found a few corn stalks mixed in the soybeans. Under federal law, the presence of even a tiny amount of a genetically engineered substance that has not been approved for human consumption makes the soybeans unfit as food for animals or humans.
The soybeans were intercepted before they could reach the human or animal food supply.
"This is an example of how biotechnology safeguarding regulations are working to ensure the integrity of the system," said Bill Hawks, USDA's under secretary for marketing and regulatory programs. "When inspectors identified noncompliant items in the ProdiGene experimental field trials, we moved quickly to ensure confinement and take appropriate actions."
In a previous case involving ProdiGene, USDA officials ordered the company to pay to harvest and incinerate 155 acres of conventional corn that may have been cross pollinated by an engineered variety grown on an adjacent test site.
ProdiGene has also agreed to set aside a $1 million bond to guarantee that it can pay for any future lapses, and submit to stricter standards for complying with federal biotechnology regulations, including a requirement for additional federal approvals before field testing and harvesting genetically modified material. The company will develop a written program with the USDA to ensure that its employees, agents and managers comply with the Plant Protection Act, federal regulations and permit conditions.
"We are pleased to put recent allegations behind us, and are optimistic about the future of bio-pharmaceuticals and their regulation," said Anthony Laos, president and CEO of ProdiGene. "We have learned some valuable lessons, and we hope the entire industry will benefit from our endeavors as we work with USDA on an enhanced compliance program.":
