The U.S. Environmental Protection Agency (EPA) announced on January 30, 2013, that it will issue a final notice of intent to cancel the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registrations for the 12 D-Con mouse and rat control products produced by Reckitt Benckiser Inc. (Reckitt). This notice is intended to effectuate a Risk Mitigation Decision for rodenticides issued by EPA on May 28, 2008. EPA contends that these cancellations are necessary because 'these products fail to comply with current EPA safety standards.' EPA will publish the final notice of intent to cancel in the Federal Register and post it in the docket available online.
According to EPA's January 25, 2013, memorandum authorizing the opening of the docket, available online, EPA will cancel the registration of 12 residential consumer rodenticide products and deny the registration applications for two residential consumer rodenticide products. After EPA publishes the notice in the Federal Register, Reckitt will have 30 days to request a hearing before an EPA Administrative Law Judge. If Reckitt does not request a hearing, the cancellations become final and effective. Reckitt has repeatedly stated that it disagrees with EPA's scientific assessment and legal conclusions, and brought litigation seeking an administrative hearing after issuance of the 2008 Risk Mitigation Decision, so it is virtually certain that Reckitt will submit the requisite hearing request.
In its January 30, 2013, announcement, EPA notes that, during the last five years, it has worked with companies to develop safer rodenticides that remain effective, affordable, and widely available to meet the needs of consumers. EPA currently requires rodenticide products for consumer use to be contained in protective tamper-resistant bait stations, and prohibits pellets and other bait forms that cannot be secured in bait stations, in order to protect children and pets from accidental exposure. In addition, EPA prohibits the sale to residential consumers of products containing brodifacoum, bromadiolone, difethialone, and difenacoum (a class of active ingredients known as second-generation anticoagulants), in order to reduce risks to non-target wildlife. The affected Reckitt consumer products contain second-generation anticoagulants. EPA still permits these same active ingredients to be applied in a residential setting by professional pest control operators.
EPA states that, for companies that complied with the new safety standards in 2011, 'EPA has received no reports of children being exposed to bait contained in bait stations.' According to the announcement, 'EPA expects to see a substantial reduction in exposures to children when the 12 D-Con products that do not comply with current standards are removed from the consumer market as millions of households use these products each year.' EPA notes that 'Reckitt Benckiser Inc., maker of D-Con brand products, is the only rodenticide producer that has refused to adopt EPA's safety standards for all of its consumer use products.'
This cancellation notice is one of the most significant cancellation actions EPA has taken in many years. The cancellation hearing process can take years to complete and can be expensive for both EPA and the affected registrants. Nevertheless, because EPA is demanding the complete removal of second-generation anticoagulant products sold by Reckitt from the consumer market, there appears to be little likelihood of a negotiated resolution without a hearing. A contested cancellation hearing requires use of formal procedures to develop an administrative record upon which the ultimate decision will be based. This formal process will likely include discovery requests and all witnesses must be made available for cross-examination, procedures that are seldom used for regulatory actions by EPA. As the hearing process gets underway, it could consume a significant amount of program management's time and attention, which could ultimately affect the program's ability to meet deadlines or deal with other matters.
The affected Reckitt products will remain registered and may be distributed and sold during the hearing process, but EPA's stated intention to cancel these products might have a chilling effect. Reckitt can be expected to contend that there is little scientific support for EPA's conclusions and to highlight the higher efficacy and lower cost of products that are not compliant with the EPA position.