U.S. EPA reregistration eligibility decision (RED) for the rodenticide cluster: overview of the regulatory process, response of registrants and stakeholders, and implications for agricultural and urban rodent control

Abstract

Author(s): Silberhorn, Eric M.; Hobson, James F.; Miller, Gerald H.; Condos, Nicholas J. | Abstract: After several years of reviewing study data and conducting risk assessments, in September of 1998 the U.S. Environmental Protection Agency (U.S. EPA) issued for comment a Reregistration Eligibility Decision (RED) document for pesticide products in the Rodenticide Cluster. The RED document covered 243 rodenticide products containing the following active ingredients: brodifacoum, bromadiolone, bromethalin, chlorophacinone, diphacinone and its sodium salt, and pival and its sodium salt. The U.S. EPA’s human health risk assessment in the RED document concluded that it was concerned about the risk to children due to accidental exposures to these chemicals through use in and around residences. With regard to ecological effects, the Agency concluded that there is a high risk of secondary poisoning, especially to mammals, from the use of these rodenticides outdoors in rural and suburban areas. In order to address the potential risks to children, the U.S. EPA initially required several mitigation measures designed to minimize exposure (e.g., addition of dye and bittering agent to formulations, labeling changes). The Agency also initiated implementation of a Rodenticide Stakeholder Process through which these and other risk mitigation measures would be discussed and required as needed. To help mitigate potential risks to non-target wildlife, the Agency initially determined that all uses of field-bait rodenticides containing more than 0.005% of chlorophacinone or diphacinone were ineligible for reregistration. The U.S. EPA also decided that all rodenticide products labeled for field use (except those limited to manual underground baiting) should be reclassified as Restricted Use pesticides. This paper reviews the regulatory process for the Rodenticide Cluster RED and discusses the response of the California Department of Food and Agriculture (CDFA) and other registrants to the requirements proposed in the RED document including formation of the Rodenticide Registrants Task Force (RRTF). It also outlines how an on-going dialogue with the Agency, both through the Rodenticide Stakeholder Process and in separate discussions, has diminished the RED requirements from those originally proposed. In addition, the paper discusses the implications and potential impacts of the current RED reregistration requirements for those applicators involved in agricultural and urban rodent control.