WASHINGTON, May 4, 2016 - Dozens of farm groups are backing Bayer CropScience’s fight to prevent EPA from canceling the registrations of an insecticide used on a wide variety of crops across the country, including soybeans, almonds, cotton, sunflowers and alfalfa. 

Cancellation of flubendiamide, which Bayer markets under the trade name Belt, will hamper growers’ ability to deal with pests, “risking significant losses and imposing crippling costs,” three dozen grower associations said in a brief filed in a case scheduled for a hearing next week before an EPA administrative law judge. 

Bayer and Nichino America, with which Bayer has a licensing, product development and marketing agreement, are challenging EPA, which proposed cancellation after the companies refused to take products made with flubendiamide off the market voluntarily. EPA contends that conditional registrations required the companies to pull the products from the market if EPA determined that they posed “unreasonable adverse effects” on the environment.

“Flubendiamide breaks down into a more highly toxic material that is harmful to species that are an important part of aquatic food chains, especially for fish, and is persistent in the environment,” EPA said when it proposed cancellation Feb. 29.

At issue is both the continued use of Belt, which is used to control more than 95 lepidopteran insect pests on more than 200 crops, and of conditional registrations. 

“Flubendiamide is among the least expensive, IPM-friendly insecticides and is less than

half the average cost of chlorantraniliprole,” a major competitor, the growers said in their brief.

IPM stands for Integrated Pest Management. 

The insecticide is used on “winter vegetables in Arizona and Florida from January through March, on tree fruits and nuts in California from March through June, on soybeans, cotton, and alfalfa from June through August, and on fall vegetables from September through December,” Bayer/Nichino said in a motion asking Chief Administrative Law Judge Susan Biro to find that the voluntary cancellation process is illegal.

But in what may be a preview of the ultimate outcome of the case, Biro denied the companies’ request on April 25, finding that they were aware of all aspects of the deal made in 2008 when they accepted the conditional registration. The hearing is scheduled from May 10-13. That decision will be reviewed by EPA’s Environmental Appeals Board.

Biro said she saw “no reason to allow petitioners out of the 2008 legal agreement they knowingly made for a ‘fast death’ cancellation arrangement.” 

The judge noted that Bayer/Nichino “only sought to challenge the voluntary cancellation arrangement as ‘unlawful’ seven years after entering into it and only when EPA sought to trigger the cancellation and make (them) live up to their end of the bargain.”

Meanwhile, the companies “financially benefited from the conditional registration, which allowed them to sell their products while pursuing data to remove the ‘uncertainty’ as to their adverse effects on the environment,” she said in the opinion.

Bayer/Nichino argue that they were “forced” to accept the voluntary cancellation provision in order to receive conditional registration. The result, they said, is that they have been denied the due process guaranteed under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

“We have a fundamental disagreement with EPA over science and process surrounding the registration of flubendiamide and Belt,” wrote Dana Sargent, Bayer’s Vice President for Regulatory Affairs recently.

But accepting a conditional registration means accepting that EPA can avoid a full-blown cancellation process, which includes peer review by the agency’s Scientific Advisory Panel and input from USDA, Biro said. 

“The courts have upheld the (EPA) Administrator’s authority to impose a wide range of conditions, including those that effectively limit cancellation proceedings for conditional registrations,” she said, citing Woodstream Corp. v. Jackson, a 2012 decision from the U.S. District Court for the District of Columbia. 

Said Biro: “Like the Woodstream plaintiffs, (Bayer/Nichino) made a business decision, likely for excellent economic reasons, and accepted the conditions and put their products on the market under conditional registrations,” Biro said. “Thus, (their) characterization that EPA ‘forced’ them into accepting the condition or gave them a ‘Hobson’s choice’ is unpersuasive.” 

Biro quoted from email exchanges between EPA and the companies, which demonstrate that “the parties negotiated the conditional terms and language” in the voluntary cancellation agreement.

One email from Bayer/Nichino said, “We…  have little problem with fitting in the ‘fast death’ approach, i.e. voluntary cancellation within a week of (EPA’s) decision” on “unreasonable adverse effects” on the environment. 

Cristen Rose, an attorney with Paley Rothman in Bethesda, Maryland, who represented Woodstream, said Biro’s decision is not surprising given the outcome in the Woodstream case. The only issue in the Belt case going forward, she said, is whether Bayer/Nichino complied with the terms in the agreement related to voluntary cancellation of registrations. The filings in the case are here.


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