The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), enacted in 1947 and amended in 1972, 1978, and 1988, established federal regulation of pesticides in order to protect human and environmental health. FIFRA has been under the jurisdiction of the U.S. Environmental Protection Agency (EPA) since the EPA’s inception in 1970. Although FIFRA requires EPA to consider the benefits of a pesticide’s use, EPA must ensure that the pesticide is used without posing unreasonable adverse effects to human health or the environment. Furthermore, the Endangered Species Act (ESA), enacted in 1973, requires federal agencies to protect species vulnerable to extinction without consideration of costs. The amendments to FIFRA in 1972, 1978, 1988, and 1996 mandated the EPA review and reevaluate the eligibility of older pesticide products for reregistration under the updated FIFRA standard, while also complying with the new environmental laws of the 1970s. Today EPA’s goal is to review existing pesticide product registrations at least every 15 years under “Registration Review.” To meet their responsibilities under the ESA, EPA is initiating consultations with the U.S. Fish and Wildlife Service (USFWS) during the Registration Review process. The first pesticide active ingredients to advance to consultations under Registration Review are those in gas cartridge products. The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) holds two gas cartridge product registrations. As a federal agency, APHIS also must comply with the ESA and consults with the USFWS on wildlife damage management activities, including tools such as pesticide products. This discussion presents APHIS’ unique ground view as a federal agency navigating the EPA’s ESA consultations during the Registration Review process, and describes the mitigation measures and their impacts on APHIS Wildlife Services’ activities.

Use of a contraceptive (i.e., fertility control) is attractive for rodent management where lethal control is unwanted. Although population reduction is generally unachievable with small-scale, short-term contraceptive use, reduced juvenile recruitment is achievable. The injectable immunocontraceptive vaccine GonaCon (active ingredient: gonadotropin releasing hormone [GnRH]) was registered in 2022 by the U.S. EPA for controlling fertility of female prairie dogs (Cynomys, a type of ground squirrel) in urban/suburban settings. Here we: 1) describe past research, including a replicated field study in Colorado (GonaCon treatment vs. control sites) testing efficacy of GonaCon in prairie dogs, which gave rise to the EPA registration of this product, 2) outline future research needs for prairie dog population management with GonaCon–Prairie Dogs, 3) describe the steps required to possibly register GonaCon for additional rodent species, and 4) describe the other fertility control pesticide products that are currently registered for use against rodents in the U.S. During the replicated field study in Colorado, prairie dogs were live-trapped in a portion (avg: 18.5%, range: 7-37%) of each colony’s total area. In treatment plots, every female captured ≥ 660 g was injected with 0.4 ml of GonaCon. GonaCon was highly effective in controlling female fertility during the first year (2019), as juvenile density was reduced 3×, but not in the second year (2020) following treatment. Treating whole colonies of prairie dogs is favored, yet if small or partial colony treatment is desired then annual GonaCon treatment may be needed. An amendment to the EPA label is in progress to allow treatment of both male and female prairie dogs. Due to recent interest from land and pest managers, other fertility control products and the steps required to possibly get GonaCon registered for additional rodent species are also outlined.

Products developed for vertebrate animals, including toxicants, repellents, contraceptives, vaccines, drugs, antimicrobials, diagnostic kits, and some devices, are regulated under a suite of federal laws. Authorization for the production, sale, and use of these products is primarily controlled by three federal agencies: the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs, the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine, and the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS). Furthermore, regulatory oversight of these products extends to research activities conducted during their development. However, determining the regulatory jurisdiction of new products can be confusing for researchers and product developers. In fact, the same product could be regulated under different laws and by more than one agency depending on its intended target population, function, product claims, and route of administration. Adding to this complexity, EPA, FDA, and APHIS have reached a series of formal and informal agreements on which agency will have primary oversight for a number of novel product types that do not clearly fall into established product categories. Here, we present a decision support tool that helps researchers and product developers identify the regulatory jurisdiction of new products, allowing them to comply with federal laws and consult with the appropriate agency early in the research and development phase. Such consultations ensure that resources are spent on studies that satisfy agency-specific data requirements for product registration, approval, and licensing.

The only pesticide currently registered for mongoose control is a product developed for rats that consists of a hard-cereal bait block. Although the active ingredient (diphacinone) is known to be highly effective for mongoose, previous studies indicate that carnivorous and omnivorous mongooses do not readily consume the hard bait matrix designed for gnawing rodents. A palatable bait matrix with a consistency more appropriate to mongoose dentition and feeding behavior will be required to develop a more effective mongoose pesticide. We evaluated the acceptance and consumption of nontoxic versions of four candidate bait matrices: FOXECUTE® and FOXSHIELD® (Animal Control Technologies, Australia; ACTA); HOGGONE® (ACTA); and a potted pork shoulder loaf containing artificial dead mouse scent developed by WS-NWRC as a bait for invasive brown treesnakes (hereafter ‘BTS bait’). We offered test groups of six mongooses one of the candidate bait matrices alongside dry dog kibble dog food as a challenge diet for five days. Because the potential active ingredients para-aminopropiophenone and sodium nitrite require accumulation of the toxicant within a relatively brief period of time to affect lethal toxicity before they are metabolized, we conditioned mongooses to feeding within only a four-hour window rather than slowly sampling the bait throughout the day. We estimated rate and amount of consumption through review of time-lapse photography of feeding trials and measured total consumption by weighing uneaten portions of bait. From the first day offered, most mongooses readily consumed ample amounts of all four bait matrices and consumed almost no challenge diet. Overall, consumption was highest and most consistent with the BTS bait. Although this trial did not clearly discriminate an optimal bait matrix, this result is highly encouraging in that we have multiple palatable options. The final selection will be based on other characteristics of the bait matrix such as longevity in the field, compatibility with the selected toxicant, and ease of manufacture, storage, and use. We provide an overview of some of these characteristics for each candidate bait type.

Small Indian mongooses are detrimental introduced predators in the United States, where they depredate native species, serve as vector of disease, and threaten public safety. Due to the risk of accidental introduction to mongoose-free islands, high cost and limitations to trapping, and no national (Section 3) Environmental Protection Agency (EPA)-registered toxicants for mongoose control, there is a need for an efficacious toxic bait for mongooses for use in conservation areas and at points of entry in the United States. Over the last five years, the National Wildlife Research Center (NWRC) worked to develop a toxic bait for mongooses for registration with the EPA. This paper outlines the development pathway to registration of a toxic bait for mongooses in the United States.