In an effort to beef up safety measures for ten potentially harmful rodenticides, the EPA published a Risk Mitigation Decision (RMD) in 2008 that describes mandatory compliance procedures for products containing the high-risk ingredients singled out by the document.
“For each registered product for which a registrant declares its intent not to comply (i.e., not to amend labeling and/or packaging and not to develop a replacement bait station product),” states the RMD, “the company needs to include a request to cancel that product voluntarily under FIFRA Section 6(f)(1). Failure to make such a voluntary cancellation request will result in additional regulatory action.[…] Rodenticide products that do not comply with this Risk Mitigation Decision that a registrant releases for shipment after June 4, 2011, would be considered misbranded.”
Reckitt Benckiser, a manufacturer of “d-CON” rodenticides, was one such company that refused to “voluntarily” cancel its registered products. However, despite their noncompliance, they were displeased to find that the EPA threatened to bring “misbranding” enforcement actions against them (which can include stop sale orders or even “seizure actions” against the product), rather than the expected (and tamer!) administrative cancellation procedures, which entitle registrants to request that certain administrative procedures be undertaken, including a hearing before an administrative law judge.
So Reckitt Benckiser took the EPA to court. The case was dismissed, remanded, and eventually decided in favor of the plaintiff: the EPA had overstepped their bounds. Specifically, the Court concluded that “Congress clearly did not intend to give EPA the authority it asserted in the RMD to bring a misbranding action in lieu of a cancellation proceeding against a product that failed to comply with the RMD.”
Arnold & Porter details the case (litigated by Arnold & Porter) in a recent advisory, and anticipates that “the Court’s opinion is likely to limit EPA’s enforcement options in areas other than the reregistration of pesticides.”