Bayer to Wage Rare Challenge of EPA Pesticide Ban

By David Schultz

March 1 — An Environmental Protection Agency proposal to enact a total ban on a Bayer insecticide sets up an unusual legal conflict between a pesticide maker and the EPA.

Bayer plans to ask an administrative law judge to overturn the EPA's proposed ban of the chemical flubendiamide, the active ingredient in the company's bug killer Belt. The EPA announced March 1 that it is seeking to ban the chemical only after asking Bayer to voluntarily pull it from the shelves, a request that Bayer denied.

The challenge to the proposed ban would mark only the second time since the late 1980s that a pesticide company has taken such an action, according to environmental and chemical attorney Mike Novak.

Novak, a partner at the law firm Keller and Heckman LLP, said he was surprised that the two parties in this dispute were unable to work through their disagreement privately.

“It's unusual for it to happen through a formal process like this,” Novak told Bloomberg BNA. “Normally there's a behind-the-scenes negotiation.”

Conditional Registration

The EPA first approved the use of flubendiamide in 2008, but it granted Bayer what's known as a conditional registration. The company could sell products containing flubendiamide but, unlike with a full registration, Bayer had to abide by certain conditions.

One of those conditions, according to the EPA, was that if new information came to light about flubendiamide showing previously unknown risks, Bayer would agree to voluntarily pull its products from the shelves.

Earlier this year, that exact scenario played out: The EPA notified Bayer that new data showed that flubendiamide could be harmful to small aquatic invertebrates that many fish rely on as a food source. In a Jan. 29 letter, the EPA asked Bayer to voluntarily nullify the registration the agency had granted it in 2008.

One week later, Bayer sent a letter in response rejecting the EPA's request.

Computer Modeling

Bayer spokesman Jeffrey Donald told Bloomberg BNA that his company submitted all the safety data on flubendiamide that the EPA had requested and that the data showed that the chemical posed no new environmental risks.

But instead of relying on the data, the EPA made its decision to ban the chemical based off of its own “theoretical computer models,” Donald said in an e-mail.

“We have years of real-world data,” Donald said. “Obviously, modeling outputs depend on what assumptions and inputs you put into the model.”

However, in the Jan. 29 letter to Bayer, EPA pesticide chief Jack Housenger told the company that it has always had concerns about how flubendiamide can accumulate in underwater soils and that his office's most recent analysis had only served to heighten those concerns.

Legal Costs

The only other time in the past several decades that a pesticide maker challenged an EPA pesticide ban was in 2013, Novak said. That's when the company Reckitt Benckiser filed suit over the EPA's decision on its d-CON rodenticide products .

The company took its fight against the EPA to both an administrative law judge and a federal appeals court but ultimately reached a settlement with the agency after two years of legal wrangling .

Novak said one can expect a similar timeline in the flubendiamide matter, noting that these types of disputes can be protracted.

“The EPA does not like to go through [this process],” he said. “It’s expensive and takes lots of legal resources. If there’s a hearing, it will take a year or two—more likely two. … During that time period, the registrations are valid and the products can be sold.”

Which Side Gets Deference?

Martha Marrapese, Novak's fellow partner at Keller and Heckman, who also specializes in environmental law, said the real question will be which side gets the benefit of deference in this dispute: Will the EPA have to prove that its scientific procedures were valid, or will Bayer have to prove that the EPA's procedures were faulty?

“It’s coming down to a dispute over science,” Marrapese told Bloomberg BNA. “This is a science dispute that will be adjudicated.”

To contact the reporter on this story: David Schultz in Washington at dschultz@bna.com

To contact the editor responsible for this story: Larry Pearl at lpearl@bna.com