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EPA Fines Monsanto for Distributing Misbranded Genetically Engineered Pesticide

Release Date: 07/08/2010
Contact Information: Stacy Kika, Kika.stacy@epa.gov, 202-564-0906, 202-564-4355

WASHINGTON - The U.S. Environmental Protection Agency announced that Monsanto Company Inc., of St. Louis, Missouri, has agreed to pay a $2.5 million penalty to resolve misbranding violations related to the sale and distribution of cotton seed products containing genetically engineered pesticides. This is the largest civil administrative penalty settlement ever received under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

"This agreement shows that when a company violates the law by distributing misbranded pesticides, EPA will take action," said Cynthia Giles, assistant administrator for EPA’s Office of Enforcement and Compliance Assurance. “The regulated community should understand that we take these violations seriously, and the public will accept nothing less than compliance.”

“People who manufacture and distribute pesticide products must follow the federal registration requirements,” said Steve Owens, assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention. “These requirements are critical to preventing the development and spread of insect resistance.”

Monsanto Bollgard and Bollgard II cotton seed products contain genetically engineered pesticides known as plant incorporated protectants (PIPs), which are registered as a pesticidal product under FIFRA. As a condition of the registrations, EPA included planting restrictions on Bollgard and Bollgard II, which contain the PIP Bacillus thuringiensis (Bt). EPA restricted planting of the cotton seed product in 10 Texas counties (Carson, Dallam, Hansford, Hartley, Hutchison, Lipscomb, Moore, Ochiltree, Roberts and Sherman) to protect against pests becoming resistant to Bt PIPs and other microbial products used in sprays and dusts. Monsanto was required to control the sale and distribution of the cotton seed by including information on the planting restrictions in its labeling and grower guides.

In 2007, Monsanto disclosed to EPA that it had distributed misbranded Bollgard and Bollgard II cotton seed to customers in the Texas counties where EPA had restricted its planting. EPA’s subsequent investigation confirmed that between 2002 and 2007, the company distributed or sold the cotton products more than 1,700 times nationwide without the planting restrictions in its grower guides and that Bollgard and Bollgard II cotton was planted in the restricted counties.

Monsanto subsequently corrected the grower guides by including the required planting restriction for the Bollgard and Bollgard II products. In September 2008, EPA lifted the planting restriction in the 10 Texas counties for Bollgard II, after Monsanto applied for a change in the registration of that product.

More information about the Monsanto consent agreement:
www.epa.gov/compliance/resources/cases/civil/fifra/monsanto-infosht.html

More information about insect resistance management in cotton:
http://www.epa.gov/oppbppd1/biopesticides/pips/bt_cotton_refuge_2006.htm

More information on the roles of EPA, USDA, and FDA in the federal regulation of genetically engineered plants:
http://usbiotechreg.nbii.gov/