Press Releases
Jim Rogers (301) 734-8563
Beth Jones (202) 720-6959
USDA INVESTIGATES BIOTECH COMPANY FOR POSSIBLE PERMIT VIOLATIONS
WASHINGTON, Nov. 13, 2002—The U.S. Department of Agriculture's
Animal and Plant Health Inspection Service, in close coordination with
the Food and Drug Administration is investigating ProdiGene, Inc., of
College Station, Texas, 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 genetically engineered corn 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 is 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.
Under the Federal Plant Protection Act, 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 for knowing violations as well as civil penalties. Any
company or individual that violates the Act faces 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.
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