USDA announces consent decree in ProdiGene case

ProdiGene and USDA have signed a consent decision and order regarding violations of the Plant Protection Act. 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 USDA for all costs to acquire approximately 500,000 bushels of soybeans in storage in Nebraska, destroy the beans and clean the facility and all equipment.

"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.”

ProdiGene also agreed to a $1 million bond and higher compliance standards, including additional approvals before field testing and harvesting genetically modified material. The company will develop a written compliance program with USDA to ensure that its employees, agents, cooperators and managers are aware of, and comply with, the Plant Protection Act, federal regulations and permit conditions.

Hawks said the soybeans never reached the human or animal food supply. USDA and FDA continue to work in close coordination to enforce current safeguards covering research in bioengineered foods, and the agencies will continue to take appropriate action to ensure human, animal and plant health.

Under the Plant Protection Act, USDA’s Animal and Plant Health Inspection Service (APHIS) regulates the movement, importation and field release of genetically engineered plants. APHIS requires significant safeguards to prevent the unauthorized release of genetically engineered material. The Act provides criminal penalties as well as civil penalties.

Companies or individuals that violates the Act face civil penalties of up to $250,000 per violation, or $500,000 per adjudication, and may have their permits revoked.

USDA has strengthened field-testing requirements for permits on genetically engineered traits that are not intended for commodity uses, such as pharmaceuticals, veterinary biologics and certain industrial products by adding new safeguards as a condition for all permits allowing the confined release of such products into the environment.

These specific safeguards include comprehensive confinement procedures, performance standards, and required monitoring/auditing practices for ensuring that out-crossing or commingling with other seeds and commodities are prevented.

As a part of the Department of Health and Human Services, FDA regulates foods and feed derived from new plant varieties under the authority of the Federal Food, Drug and Cosmetic Act. FDA policy is based on existing food law and requires that genetically engineered foods meet the same rigorous safety standards as is required of all other foods.

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