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Make my day! - registrant gets court to order EPA to cancel their product


Source: Acta Group

Industry stakeholders won a major victory Jan. 28 when Judge Ellen Huvelle of the U.S. District Court for the District of Columbia
ruled EPA could not circumvent FIFRA’s cancellation procedures in its actions regarding 10 rodenticide active ingredients (see
story, Page 1). Jim Aidala, former Assistant Administrator of EPA’s Offi ce of Chemical Safety and Pollution Prevention, delves into
the background of the case and assesses its wider implications, including possible next steps for EPA and other stakeholders.

Reckitt Benckiser is a manufacturer of a variety of household cleaning and pesticide products, including rodenticides, sold widely under the D-Con brand. In recent years Reckitt Benckiser has formulated rodenticide products using what is known as a “second-generation” anti-coagulant, brodifacoum. The term second-generation refers to the lack of resistance in rodents, which has developed in some cases to earlier, “fi rst-generation” anti-coagulant products, such as warfarin.

In May 2008, EPA issued a Risk Mitigation Decision for brodifacoum (and nine other rodenticide active ingredients). Concerning the use of brodifacoum, the decision described EPA’s rationale for removing its use from household consumer products, and as such, EPA declared it would consider any products sold after June 2011 as “misbranded” under FIFRA. Registrants of brodifacoum products, including Reckitt Benckiser, had been meeting with EPA for an extended period discussing the use of brodifacoum as a household rodenticide and whether reports of accidental or unintended exposures by children or non-target animals warranted further restrictions or removal from the marketplace. The decision in May 2008 articulated EPA’s concerns with brodifacoum and other second-generation products as the basis for wanting to declare any such products sold after June 2011 as misbranded.

FIFRA authorizes EPA to take a variety of different actions to ensure that statutory requirements are met. In the situation where EPA concludes that a pesticide no longer meets the standard for registration, the law allows EPA to seek to “cancel” the pesticide’s registration (or in the case where EPA might conclude an imminent hazard exists, EPA can “suspend” the registration) through a
formal administrative proceeding. FIFRA also allows EPA to stop the sale of products that it concludes are misbranded due to labels that EPA claims are false or misleading, among other reasons.

In this situation, where EPA informed registrants that their products would be considered misbranded after a certain date, Reckitt (among other registrants) contended that the appropriate tool for EPA was to propose to cancel its FIFRA registrations. A cancellation order would allow the affected registrants the opportunity for an evidentiary hearing as proscribed under the law to rebut EPA conclusions that the product’s risks were excessive or otherwise unacceptable under FIFRA. The declaration to consider products misbranded after a certain future date was seen by the registrants as a way to have EPA effectively cancel the product without using the appropriate cancellation mechanism, because the threat of EPA enforcement action against anyone who sold the products after a certain date would likely cause sales to vanish. The lack of a cancellation order would also prevent the registrants from being able to use the cancellation administrative process publicly to rebut EPA’s conclusions.

Cancellation hearings can be protracted and resource intensive as they are a full evidentiary hearing where the entire decision-making record must be developed de novo. Subpoenas can be issued, and witnesses for the government and registrant are subject to discovery and crossexamination. In the past, some cancellation hearings have taken many years and great expense in time and resources. They are generally considered to be an option that both EPA and the registrant in question hope to avoid due to the time and expense involved. Although there are thousands of registered pesticides, and over time, hundreds have been removed from the market, relatively few cases have resulted in cancellation hearings to resolve a dispute between EPA and a registrant. Avoidance of cancellation hearings is also not seen as a partisan affair; both Democratic and Republican administrations have been criticized for the practice (the rodenticide case here was initiated under the Bush administration in 2008).

In this case, however, Reckitt sought a judicial order for EPA to issue a cancellation order in lieu of its decision that brodifacoum products would be considered misbranded. Reckitt contended that the misbranding option would allow a challenge only after the market for its product had evaporated, which is not what FIFRA calls for in a case where there is a signifi cant disagreement between the registrant and EPA.

Reckitt has stated in the past that brodifacoum does not present excessive risks, citing, among other things, that the vast majority of accidental exposures do not cause any signifi cant harm. Reckitt also argues that hospitalizations and serious injury are relatively infrequent, especially given the millions of applications of these products used each year. And brodifacoum products, under EPA’s approach, would only be available if used by a professional applicator, which would price the availability of the product out of reach for most lowerincome users who are among those who are the most in need of rodent control. EPA claims to have considered all of these arguments and nonetheless concluded that brodifacoum should be more restricted.

Who is correct is not the point; Reckitt’s argument was that cancellation proceedings were the way EPA should propose its restrictions and that a cancellation order, not a threat of misbranding, was the appropriate statutory instrument.

In this case, the court ruled that Reckitt was correct — the misbranding threat was equivalent to a cancellation order but EPA used the  wrong tool; it should issue a cancellation order instead. This will allow Reckitt the rights and opportunities to challenge the cancellation order using the FIFRA administrative procedures.

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