EAB Upholds EPA Cancellation of Flubendiamide Registrations
On July 29, 2016, the Environmental Appeals Board (EAB or Board) issued its Final Decision and Order (Order) upholding the Administrative Law Judge (ALJ) Initial Decision and an earlier order denying Bayer CropScience LP and Nichino America, Inc.’s (BCS/NAI) Motion for Accelerated Decision that held that the U.S. Environmental Protection Agency (EPA) was authorized to cancel the conditional flubendiamide registrations under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(e) and did not need to provide BCS/NAI the full Section 6(b) cancellation process. The Board also upheld EPA’s determination prohibiting BCS/NAI from the continued sale, distribution, and use of existing stocks of flubendiamide products, but found that EPA’s determination to prohibit the continued sale and distribution of existing stocks of flubendiamide end-use products by distributors and retailers other than BCS/NAI was not supported by the record.
Additional information regarding this case is available in our blog items EPA ALJ Issues Initial Decision in Bayer Flubendiamide Cancellation Proceeding, EPA ALJ Denies Bayer’s Motion for Accelerated Decision and Flubendiamide Registrants and EPA File Post-Oral Argument Briefs.
The EAB summarized BCS/NAI’s arguments concerning the overall proceeding with two questions: (1) whether EPA has properly initiated this cancellation action under Section 6(e) rather than Section 6(b); and (2) if the proceeding is properly initiated under Section 6(e), whether BCS/NAI can nonetheless challenge the lawfulness of a condition in their registrations in a Section 6(e) proceeding.
With regard to the first issue, the Board found that EPA appropriately commenced the proceeding under the expedited cancellation procedures set forth in FIFRA Section 6(e) because two criteria were satisfied: (1) the registration must have been issued as a conditional registration under FIFRA Section 3(c)(7); and (2) EPA must have determined that BCS/NAI failed to satisfy a condition of that registration. The Board found that “neither the plain language of the statute, its structure, nor legislative history” supported BCS/NAI’s argument that if EPA “has made an unreasonable adverse effects finding, FIFRA’s general cancellation provision in section 6(b) trumps section 6(e) and bars the Program from initiating a 6(e) cancellation proceeding, even where the elements for a section 6(e) cancellation are met.” The Board further stated: “Bayer and Nichino’s argument that section 6(b) takes priority over section 6(e) is inconsistent with the structure and environmental protection goals of FIFRA.” Instead, EAB states:
- Given Congress’ decision to add an expedited cancellation provision to FIFRA — separate and independent from section 6(b) — it is difficult to square FIFRA’s environmental protection goals with Bayer and Nichino’s argument that the Pesticide Program must use the more time-consuming and resource-intensive section 6(b) procedures to cancel a pesticide in circumstances where section 6(e)’s expedited procedures are applicable. That is particularly the case when one considers that, unless the Program issues an “emergency order,” a registrant is allowed to sell and distribute the pesticide during the course of section 6 cancellation proceedings. See FIFRA § 6(b)-(c), 7 U.S.C. § 136d(b)-(c). If the Program were required to initiate cancellation proceedings under section 6(b) instead of under section 6(e), registrants would, in effect, be rewarded with additional time to sell and distribute their pesticides. Had Congress intended such a result, it could have subordinated section 6(e) to section 6(b) when it added the new conditional registration authority (including section 6(e)) to the existing statutory structure in 1978. See S. Rep. No. 95-1188, at 11 (1978) (Conf. Rep.). But Congress did not take such a step. Rather, in creating the possibility of allowing pesticides to be introduced to the market conditionally when they could not meet all the requirements for a general registration, Congress took steps to assure that such pesticide registrations could be promptly canceled when the terms of the conditional registrations were not met.
The Board also found that BCS/NAI could not demand a Section 6(b) cancellation proceeding because they “willingly accepted the termination condition in 2008 and 2009, knowing that it required them to submit a request for voluntary cancellation if the Program were to issue a determination that flubendiamide causes unreasonable adverse effects.” EAB stated: “Given the language of the conditional registrations, Bayer and Nichino’s affirmative concurrence on that language, and the record of negotiations, we find that Bayer and Nichino willingly agreed to the termination condition, knowing that they were agreeing to an approach that could remove the flubendiamide products from the market rapidly. Having knowingly agreed to this procedure, they cannot contest it now.”
With regard to the second issue as to whether BCS/NAI can nonetheless challenge the lawfulness of a condition in their registrations in a Section 6(e) proceeding, EAB found that the scope of a Section 6(e) cancellation is “narrowly limited to the following issues: (1) whether the condition was satisfied, and (2) whether the Pesticide Program’s determination on the appropriate disposition of the existing stocks of the canceled pesticide is consistent with FIFRA.” The Board found that the facts in this particular case demonstrated that BCS/NAI “had ample opportunity to challenge the lawfulness of the termination condition in a timely and permissible way but failed to do so.” EAB noted, for example, that BCS/NAI could have declined to accept the registration terms and challenged EPA’s refusal to grant a conditional registration with terms acceptable to BCS/NAI. The Board further found that BCS/NAI understood the consequences of agreeing to the condition at issue and thus “knew, or should have known given the clarity of section 6(e), that any objection they had to the condition giving the Pesticide Program the option to effectively require cancellation without instituting a section 6(b) proceeding could not be raised in a section 6(e) cancellation for failure to comply with the termination condition.”
As for the specific issues that the Board stated were properly before it in this appeal, it found BCS/NAI did not comply with their obligation to submit voluntary cancellation requests. The Board rejected arguments that BCS/NAI’s failure to request cancellation is excused because EPA did not meet an important pre-condition to the termination condition by “engaging in dialogue” with BCS/NAI regarding the data and EPA’s conclusions related to that data. Specifically, the Board found that this objection was not timely raised and thus was precluded, but that even if it had not been precluded, BCS/NAI had failed to establish by a preponderance of the evidence that EPA did not engage in such dialogue.
One aspect of the EPA’s determination that was overturned relates to whether existing stocks can continue to be sold or distributed. Although the Board upheld as reasonable EPA’s denial of the sale and distribution of existing stocks by BCS/NAI because they violated the termination condition, EAB amended EPA’s existing stocks determination described in the Notice of Intent to Cancel “to allow distributors and retailers other than Bayer and Nichino to sell and distribute end-use flubendiamide products that have been formulated, packaged, and labeled for use and [that] have been shipped or released into commerce to distributors on or before the date of this Final Decision and Order, until those stocks are exhausted.” EAB instead stated that EPA’s “rationale for denying the sale and distribution of existing stocks by Bayer and Nichino — because they violated the terms of their conditional registrations — has limited, if any, applicability to non-registrants.” Distributors and retailers other than BCS/NAI can continue to sell and distribute end-use flubendiamide products that were formulated, packaged, and labeled for use and shipped or released into commerce to distributors on or before the date of this Final Decision and Order, until those stocks are exhausted.
Although the resolution of this case has potential implications for current and future registrations, EPA has acknowledged the unique circumstances of this case, and indicated that it is unlikely that a conditional registration like that issued for flubendiamide will be issued again. If a registrant ever finds itself in a similar position to BCS/NAI, or facing a situation, as EPA has indicated, that seeks a condition of registration that would allow a registration to simply expire, such companies should carefully consider how to proceed, including considering options to challenge the lawfulness of the condition proposed by EPA or to demonstrate that the applicant/registrant is entitled to a general, not conditional, registration.