Bayer Crop Science is refusing EPA’s request to voluntarily pull its Belt insecticide off the market due to the agency’s environmental concerns.
“We believe it is an important tool for farmers and can be used safely and effectively,” Dana Sargent, vice president of regulatory affairs at Bayer, told AgWeb prior to the company’s announcement Friday. Bayer criticized the methods used by EPA to evaluate flubendiamide. (Click here to read Bayer's full release.)
EPA on Friday disagreed and said it would move to cancel flubendiamide's registration.
"EPA issued a time-limited registration to Bayer CropScience and Nichino America for flubendiamide to better understand the potential impact of the product's metabolite to degrade in the environment and its toxicity. The agency also wanted to be able to quickly take this product off the market if there were problems. EPA required additional studies that found the product degrades or breaks down into a material which is more toxic than flubendiamide, is extremely toxic to aquatic species and is persistent in the environment," the agency said in a statement. "Primarily for these reasons, EPA concluded that continued use of the product will result in unreasonable adverse effects on the environment and notified the company to request voluntary cancellation consistent with the conditions of the original registration. The companies have indicated that they do not intend to comply with that condition. EPA will move forward with cancellation proceedings, according to the statute, if the companies in fact fail to comply with the condition."
Bayer Pushes back on EPA's Insecticide Complaints
Sargent said the issue is bigger than any one product and questioned the EPA’s support for production agriculture.
“Denying a product’s registration and ignoring its safe use history based on unrealistic theoretical calculations calls into question the EPA’s commitment to innovation and sustainable agriculture,” said Sargent.
The chemical, which is an active ingredient in Bayer’s Belt insecticide, was registered in 2008. It works on lepidoterous pests such as armyworms, bollworms, corn borers and more, though it is most commonly used on tree nut crops like pistachios. It is also approved for use on more than 200 crops, including corn, cotton, stone fruits, grapes and vegetables and is typically used as a mid-season foliar spray.
Listen to Jeff Donald of Bayer Crop Science on Agritalk
At issue right now is flubendiamide’s impact on freshwater benthic organisms, which live in the sediment of rivers, lakes and streams. While EPA did flag this as a concern in the 2008 registration statement, Bayer says that more than four years of its own data, plus U.S. Geological Survey data, show that flubendiamide has not had a negative effect on the environment.
“Bayer strongly disagrees with the EPA’s methodology, which is based on theoretical models and assumptions that exaggerate risk,” the company said. “Years of water monitoring studies have shown residues of flubendiamide and its metabolite are well within safe levels established for aquatic invertebrates.”
“We are disappointed the EPA places so much trust on computer modeling and predictive capabilities when real-world monitoring shows no evidence of concern after seven years of safe use,” said Peter Coody, Ph.D., Bayer vice president of environmental safety.
It represents a frustrating situation for Bayer, which received the request to voluntarily cancel flubendiamide’s registration in January. Developing a new active ingredient typically takes about 10 years and costs $250 million, according to Bayer.
With so much at risk—and so much disagreement over the data—Bayer decided to reject the EPA’s request. It has requested an administrative law hearing to review flubendiamide’s registration, which is a process that could take several months.
Will this affect farmers? Not for the moment. Ag retailers and growers are allowed to keep selling, buying and using flubendiamide while the product is under review.
What do you think of Bayer's decision to deny EPA's request to pull this insecticide? EPA's reasoning for pulling flubendiamide? Let us know in the comments.