EPA appeals board upholds cancellation of Bayer's Belt

By Stephen Davies

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WASHINGTON, July 29, 2016 - EPA's Environmental Appeals Board has upheld the cancellation of flubendiamide, a Bayer CropScience insecticide sold under the trade name Belt, but will allow existing stocks to be sold by retailers.

The EAB decision, issued late this afternoon, upheld an earlier ruling by an administrative law judge who said Bayer and fellow registrant Nichino America willingly agreed with the terms of conditional registrations they received in 2008: that if EPA determined flubendiamide caused “unreasonable adverse effects” on the environment, then the companies would have to voluntarily cancel their registrations.

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When EPA made the “unreasonable adverse effects” determination on Jan. 29, however, the companies decided to file an administrative challenge.

In its decision, the three-judge EAB said that under the Federal Insecticide, Fungicide, and Rodenticide Act, Bayer and Nichino could not challenge the conditions of the registration. Said the EAB:

“The scope of a cancellation hearing under FIFRA section 6(e) is narrowly limited to the resolution of two issues: (a) whether registrants have complied with the conditions of registration (or have initiated and pursued appropriate action toward fulfilling those conditions), and (b) whether the (EPA) Pesticide Program's determination with respect to the continued sale and use of existing stocks is consistent with FIFRA.”

By failing to request voluntary cancellation of their flubendiamide registrations within a week of EPA's determination that flubendiamide causes unreasonable adverse effects, Bayer and Nichino “failed to satisfy the termination condition in their flubendiamide registrations,” the EAB said.

Dana Sargent, Bayer's vice president of regulatory affairs, said in a press release, "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.”

“The ruling was narrowly focused on process issues around the registration," she said. "It is notable that it did not weigh in on the lawfulness of EPA's cancellation nor did it consider the fundamental science underpinning Bayer's argument.”
In a victory for ag dealers, however, the EAB disagreed with EPA's and the ALJ's decision that existing stocks could not be sold. That could be important for Southern growers currently fighting larval infestations.

The Office of Pesticide Programs “did not make a specific unreasonable adverse effects determination with regard to flubendiamide existing stocks,” the EAB said. However, OPP did say that if its existing stocks determination were overturned, it would not continue to oppose sales of the product remaining in the hands of dealers.

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Bayer and Nichino argued to the EAB that OPP should not be allowed to avoid substantive review of its unreasonable adverse effects finding “by presenting powerless entities the Hobson's choice of either accepting conditions designed to bypass the cancellation process or receiving no registration at all.”

The EAB disagreed, saying that the companies “were offered a real choice, not an illusory or Hobson's choice. In 2008, (OPP) offered them either, (1) a registration with conditions that the Program found necessary to meet the terms of FIFRA, or (2) the opportunity under FIFRA section 6(b) and the applicable regulations to dispute (OPP's) conclusion that such conditions were legally required.”

Bayer and Nichino “had an alternative - the same alternative available to any applicant for a government license: accept the government's decision on its application or challenge the government's determination either administratively or in court.”

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