Bayer Announces That It Will Not Submit Voluntary Cancellation Requests for Flubendiamide

Significant issues concerning the scope of the U.S. Environmental Protection Agency’s (EPA) authority to cancel conditional registrations are raised by recent events concerning flubendiamide products sold in the U.S. by BayerCrop Science LP (Bayer) under the trade name Belt.  Bayer announced on February 5, 2016, that it will not comply with EPA’s request that Bayer “voluntarily” cancel its registered flubendiamide products.  In a January 29, 2016, letter, EPA stated that flubendiamide and a  degradate compound are “mobile, stable/persistent, accumulate in soils, water columns and sediments and are toxic to aquatic invertebrates.”  Based primarily on EPA’s ecological risk assessment, EPA has determined “that the continued use of the currently registered flubendiamide products will result in unreasonable adverse effects on the environment.”  Bayer disagrees strongly with the EPA risk assessment, because Bayer believes it is based on overly conservative modeling estimates that cannot be reconciled with actual monitoring and environmental fate data for this pesticide.

Conditional registrations for pesticides containing flubendiamide were first granted by EPA under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(7) in 2008.  As one condition of registration, EPA required Bayer to conduct specific environmental fate studies, which have now been submitted and reviewed.  EPA also adopted an initial expiration date for all registrations of flubendiamide products of July 31, 2013, which EPA later agreed to extend several times to allow time for further review and discussion of the submitted data.  The current dispute with Bayer involves a specific condition that EPA included in its preliminary acceptance letter for this active ingredient, which EPA contends obligates Bayer to request voluntary cancellation of the registrations now that EPA has made a finding of unreasonable adverse effects.  Bayer characterizes the condition in question as “unlawful,” and argues that EPA must afford Bayer a full adjudicatory hearing under FIFRA Section 6(b) before the registrations can be cancelled.

Commentary

Because Bayer has not submitted the “voluntary” cancellation requests demanded by EPA, EPA has stated that it will initiate the cancellation process for conditional registrations established by FIFRA Section 6(e).  Although this process affords Bayer an opportunity for an administrative hearing, the issues in a conditional registration hearing under FIFRA Section 6(e) are limited to “whether the registrant has initiated and pursued appropriate action to comply with the condition,” and the EPA determination concerning disposition of existing stocks.  Bayer argues that the condition as it was originally imposed by EPA was improper and denies statutory due process rights, and that EPA must afford Bayer a full adjudicatory hearing under FIFRA Section 6(b) rather than the limited hearing provided under FIFRA Section 6(e).

This dispute presents a variety of important legal questions, including what authority EPA has under FIFRA to impose time limitations or expiration dates for pesticide registrations, the rights a registrant has when it applies to amend or to renew a time-limited registration, and the nature of the conditions that EPA may lawfully impose for a conditional registration under FIFRA Section 3(c)(7).  The entire pesticide industry will be watching this matter with great interest.