On February 29, 2016, the U.S. Environmental Protection Agency (EPA) released a prepublication copy of a notice of intent to cancel all Bayer CropScience, LP and Nichino America, Inc. (BCS/NAI) flubendiamide products. The affected products are:
- EPA Reg. No. 264-1025 -- BELT SC Insecticide;
- EPA Reg. No. 71711-26 -- FLUBENDIAMIDE Technical;
- EPA Reg. No. 71711-32 -- VETICA Insecticide; and
- EPA Reg. No. 71711-33 -- TOURISMO Insecticide.
The cancellation notice was issued by EPA, pursuant to Section 6(e) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and announces EPA’s intent to cancel the registration of these four products based on the registrants’ failure to comply with a required condition of their registrations. Under this condition, which EPA alleges was agreed to by the registrants, each flunbendiamide registrant is required to submit a voluntary cancellation request if EPA finds that the product causes unreasonable adverse effects on the environment.
EPA made such a finding of unreasonable adverse effects in a decision memorandum issued on January 29, 2016, but BCS/NAI has rejected EPA’s request to submit a voluntary cancellation. More information on BCS/NAI’s refusal to submit a request for voluntary cancellation is available in our blog item Bayer Announces That It Will Not Submit Voluntary Cancellation Requests for Flubendiamide.
EPA’s finding of unreasonable adverse effects is based on the purported risk to aquatic invertebrates associated with flubendiamide. More information on EPA’s rationale, including the decision memorandum, is available on EPA’s website. After the cancellation notice is published, each registrant will have 30 days to request a hearing concerning the notice. FIFRA Section 6(e) provides that the only matters that may be considered in the resulting hearing are whether the registrants have complied with the condition in question and whether EPA’s determination on existing stocks is consistent with FIFRA. In contrast, the registrants have stated that EPA is required to provide an adjudicatory hearing concerning the substantive basis for EPA’s determination that the products in question cause unreasonable adverse effects on the environment.
The dispute between BCS/NAI and EPA concerning cancellation of the conditional registrations for flubendiamide products will be carefully watched by the pesticide industry. The critical issue is whether EPA can effectively circumvent the adjudicatory hearing that would otherwise be available on the substance of EPA’s determination concerning risks and benefits by imposing a condition that requires affected registrants to accept EPA’s determination. EPA will argue that the registrants accepted the condition in question when the registrations for flubendiamide were first issued. The registrants will argue that EPA may not use such a condition to constrain hearing rights because this contravenes the intent of FIFRA.