District Appeals Court Says EPA Misbranding Authority is Ripe for Review
The Court of Appeals for the District of Columbia Circuit (CADC) has ruled that manufacturers may appeal Environmental Protection Agency “misbranding” actions in district court when the agency’s actions effectively threaten to cancel a product’s registration without due hearings and argument.
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RMD Imposed Restrictions on Ten Rodenticide Ingredients
In the Risk Mitigation Decision (RMD) at issue, designed to reduce the exposure of children and wildlife to ten different rodenticide products1, the EPA:
1) required the products be sold only in tamper-resistant bait stations, not in loose form;
2) set restrictions on weight, labeling, and distribution, and;
3) ended the marketing to consumers of any second-generation anticoagulant (brodifacoum, bromadiolone, difenacoum, difethialone).
EPA Threatened “Misbranding” Sanctions to Enforce RMD
The EPA did not initiate registration cancellation proceedings but instead, in August 2008, it notified Reckitt Benckiser Inc., a pesticide manufacturer, that as of June 14, 2011, its products with rodenticides covered by the RMD, including D-Con, would be considered misbranded unless the company made the changes detailed in the RMD.
(Products determined to be misbranded under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) include pesticides with packaging which does not adequately prevent against accidental ingestion, or labeling which does not contain directions or warnings “adequate to protect health and the environment.” The EPA is empowered, among other steps, to issue “stop sale, use or removal” orders for such items.)
“Misbranding” Ploy Allowed EPA to Avoid Hearings
If the EPA cancels a product’s registration under section 6 of FIFRA, registrants can demand hearings before an administrative law judge to present evidence and argument. Instead, EPA has used the threat of identifying products with the newly restricted ingredients as misbranded if they were not brought into conformity with the RMD.
Manufacturer Sued EPA, But District Court Found no Jurisdiction
Reckitt Benckiser notified the EPA that it intended to challenge the RMD under FIFRA’s cancellation procedures, but the district court ruled that the company’s claim amounted to a re-registration issue and so fell outside the normal jurisdiction of the court as defined for EPA appeals under FIFRA.
Appeals Court Finds EPA’s Tactics Not “Appropriate Regulatory Action”
The appeals court overruled, holding that misbranding authority represents “final agency action” which would impose hardship, and thus gives the company the right to an appeal in district court, the normal venue under FIFRA to appeal EPA actions that are not preceded by public hearings. The “EPA’s interpretation of its FIFRA misbranding enforcement authority … cannot properly be viewed as a form of ‘appropriate regulatory action’,” the court ruled, finding the scope of the agency’s misbranding authority to be ripe for review.
1The ten products covered by the RMD are the “first generation” anticoagulants warfarin and its sodium salt, chlorophacinone, diphacinone and its sodium salt, the “second generation” anticoagulants brodifacoum, bromadiolone, difenacoum, and difethialone, and the non-anticoagulants bromethalin, cholecalciferol, and zinc phosphide.