EPA Upholds Decision to Cancel Bayer’s Flubendiamide

The U.S. Environmental Protection Agency’s Environmental Appeals Board (EAB) has upheld an earlier EPA decision to cancel registration for Bayer’s insecticide flubendiamide, marketed in the U.S. as Belt, but is allowing sales of existing stocks to growers.

The EAB overruled EPA’s proposed existing stocks determination and will permit distributors and retailers to distribute and sell remaining flubendiamide inventories, and permit growers to continue using product consistent with label use directions.

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While Bayer intends to comply with the order, it said it will fully review the EAB’s decision and evaluate its options going forward.

The ruling follows an earlier appeal to the EPA’s Administrative Law Judge, who ruled in favor of the Agency after excluding any documentary evidence and testimony regarding the scientific issues raised by EPA’s actions on flubendiamide.

“Bayer maintains the EPA’s actions on flubendiamide are unlawful and inconsistent with sound regulatory risk assessment practices. The science supporting the registration of flubendiamide may be complex, but it is solid, and it’s unfortunate that we were denied the opportunity to argue the scientific merits of our case. You cannot use the regulatory process as a shield to avoid engaging in meaningful dialogue, but that is exactly what the EPA has done,” said Dana Sargent, Bayer’s Vice President of Regulatory Affairs.

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She added, “Since we first learned of the EPA’s actions on flubendiamide a few months ago, we have tried our best to argue on behalf of our industry and the many growers who depend on these products for sustainable pest control. In the end it is they who will be most impacted by this decision.”

Background

In March, EPA issued a notice of intent to cancel all Bayer CropScience and Nichino America’s flubendiamide products “that pose a risk to aquatic invertebrates that are important to the health of aquatic environments.”

“Required studies showed flubendiamide breaks down into a more highly toxic material that is harmful to species that are important part of aquatic food chains, especially for fish, and is persistent in the environment,” the agency said. EPA concluded that continued use of the product would result in unreasonable adverse effects on the environment. EPA then requested a voluntary cancellation.

In making a determination about flubendiamide’s safety, Sargent said that the EPA over-relied on theoretical modeling rather than real-world studies, which have shown residues are “well within previously established safe levels.”

Previously, EPA requested real-world studies to learn if the product would cause harm to a particular aquatic invertebrate species. It earlier concluded that flubendiamide poses no risk of concern to humans (either through diet or worker exposure), fish, mammals, crustaceans, mollusks, beneficial insects, pollinators, or plants.

According to Sargent: “Over the course of five years, we conducted real world monitoring to study Belt’s impact in the one area in which EPA raised a question. The results were clear – residues of Belt were below levels EPA said may pose harm. Unfortunately, instead of accepting that real world data, EPA based its decision on theoretical computer modeling which is, of course, dependent on many assumptions and inputs. We fundamentally disagree with EPA’s over-reliance on theoretical modeling when real-world studies have shown residues are well within previously established safe levels. We think this should be subjected to independent review.”

Belt is registered for use on nearly 200 crops in the U.S., including tree nuts and fruit in California to soybeans and cotton in the east.

Growers, retailers and distributors with questions about this issue, should contact their local Bayer Field Sales Representative, or call 1-866-99-BAYER (1-866-992-2937).

Source: Bayer CropScience

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