Bayer CropScience prepares for EPA review of Belt SC Insecticide

Bayer CropScience is moving toward a full review of its pesticide flubendiamide before the U.S. Environmental Protection Agency’s Administrative Law Court, a company official said recently.

 

EPA asked Bayer in recent weeks to voluntarily cancel the 2008 conditional registration for Belt SC Insecticide. The company refused and the agency moved to cancel anyway.

 

Dana Sargent, vice president of regulatory affairs North America at Bayer, said the next step is what she said will be the first-ever administrative review under Section 6E of the Federal Insecticide, Fungicide and Rodenticide Act, or FIFRA, governing conditional registrations.    

         

“This particular product and the conditions of registration are fairly unique,” she said.

 

When the EPA approved the conditional registration, it did so with what Sargent said was a unique agreement with Bayer that flubendiamide would be voluntarily cancelled if not all of the scientific data collection requirements satisfied the agency.

 

Bayer agreed to voluntary cancellation originally, Sargent said, because the company was confident it could and did meet the conditions of the registration.

 

Nowhere in Section 6E is EPA allowed to cancel a conditionally registered product even if a company like Bayer agreed to do so, she said. The company believes it is entitled to a full, independent scientific review of the data before Belt is cancelled, she added.

 

Following a 30-day public comment period, the administrative court will view all data from both Bayer and EPA — either way the court has to render a decision within 75 days.

 

Sargent said an appeal is likely if Bayer loses. If that happens, farmers would be allowed to use remaining stockpiles of Belt.

 

There are a number of reasons why the company didn’t volunteer to pull the product, she said.

 

“We strongly believe that the data we provided shows that under real-world use, Belt is not a problem in the environment,” Sargent said.

 

The Belt label requires applicators utilize buffer strips to protect water and she said the company’s monitoring and studies by the U.S. Geological Survey have at most detected only minute residues — in parts per trillion — that fall well below risk levels established by EPA.

 

“In this particular case, we really believe they are significantly exaggerating the concern and we continue to think it an important tool,” Sargent said.

 

EPA “would not move away from their theoretical model,” she said, as the company tried to “negotiate some enhancements” to the data.

 

Belt is specific to caterpillar pests and it allows farmers to target when they have a particular pest pressure, Sargent said.

 

Belt is not systemic and has a different mode of action than alternative chemistries, which makes it an important resistance management tool, she said.

 

EPA’s environmental concerns rest with benthic organisms — worms, clams, crabs, lobsters and other tiny organisms that live in the bottom sediments. Apart from this concern, Sargent said, the product has a good safety profile for birds, fish and all other mammals.

 

 

Federal law says cancellation is possible if companies with conditional registrations are unable to satisfactorily show EPA the chemicals are environmentally safe.

 

EPA issues conditional registrations for products that are “identical or substantially similar” to any currently registered pesticide, or that “differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment,” according to EPA.

 

If a conditional registration is granted, federal law requires registrants to submit or cite the same data required for unconditional registrations of similar products.

 

Conditional registrations allow companies to move a product to market more quickly as they work toward full registration by providing additional scientific safety data during a period of years, Sargent said.

 

About 50% of all agriculture uses of flubendiamide are on soybeans, according to EPA. The pesticide is used on only about 1% of soybeans in the United States.

 

 

The number of conditional registrations issued for agriculture chemicals compared to the overall number of pesticides registered suggests such registrations are rare.

 

DTN found there are at least 45 conditional registrations for pesticides and other agriculture products related to row-crop production issued between 2000 and 2014. They are at varying stages in the process.

 

EPA conditionally registered a total of 149 pesticides and other products between 2000 and 2014, according to the agency.

 

EPA data shows just 16 such registrations were canceled between 2000 and 2014. As of September 2010, a total of more than 16,000 pesticides were registered for use in the United States.

 

Environmental groups and others have criticized EPA for not fully tracking conditional registrations — a concern bolstered in an August 2013 report by the U.S. Government Accountability Office, or GAO.

 

Environmentalists are concerned such chemicals may be causing environmental harm by being on the market for many years without being fully vetted by EPA.