| Technology Registration Unit
The NWRC Registration Unit is responsible for providing data and information to support regulatory approval of new or existing products needed by Wildlife Services (WS) Operations. These products allow the WS Program to more efficiently address wildlife damage issues and protect agriculture, human health, and endangered species or critical habitats. To meet this responsibility, the Registration Unit works closely with APHIS headquarters staff in Riverdale, MD, and with NWRC scientists to ensure that regulatory studies meet U. S. Environmental Protection Agency (EPA) and U.S. Food and Drug Administration (FDA) regulatory guidelines.
APHIS currently holds registrations through the EPA for 10 active ingredients formulated into 23 federally registered vertebrate pesticide products. These products meet the needs of bird management (five avicides and one avian repellent), rodent management (11 rodenticides and one fumigant), predator management for livestock protection (two predacides and one fumigant), and a toxicant for managing brown treesnakes on Guam. These registrations include three anticoagulant rodenticide products recently registered for eradication of rodents in critical island habitats.
APHIS also holds three Investigational New Animal Drug (INAD) authorizations from FDA to continue the development of one wildlife contraceptive (GnRH), and to permit Wildlife Services use of two immobilizing agents [alpha-chloralose and propiopromazine hydrochloride (PPZH)]. During 2006, EPA and FDA agreed that contraceptives for use in wildlife and feral animal populations would be regulated by the EPA. As a result, APHIS is now conducting all research on DiazaCon under the authority of the EPA. In addition, APHIS is the process of transferring all research and registration activities on GnRH (GonaCon) to the EPA.
Vertebrate control products authorized for use by EPA (gas cartridge, DRC-1339, compound 1080, methiocarb, sodium cyanide, zinc phosphide, strychnine, brodifacoum, diphacinone, M-44, egg oil).
Vertebrate control products authorized for investigational purposes by FDA (GnRH, PPZH, alpha-chloralose).
With the exception of the gas cartridge and strychnine, all USDA/APHIS vertebrate pest control products are restricted-use compounds and intended for use by Wildlife Services employees or people under their direct supervision.
Downloadable Factsheet on Registration 520K
Registration Program Support Activities
Regulatory Oversight of Contraceptives and Immobilizing Agents
The primary regulatory event recently impacting APHIS is a change in the regulatory oversight of the immobilizing and contraceptive agents. In early fiscal year (FY) 2006, FDA and EPA began negotiations to draft a Memorandum of Understanding (MOU) between themselves. The draft MOU specifies that the regulation of contraceptive materials for wildlife and feral animals (deemed pests under the Federal Insecticide, Fungicide and Rodenticide Act) would be transferred to EPA. FDA would retain regulation of contraceptives used in companion animals, livestock, and zoo animals. In conjunction with this draft MOU, FDA notified APHIS that all of the INADs APHIS holds should be closed.
In response, APHIS has closed the INAD for DiazaCon, an oral contraceptive under development for monk parakeets and prairie dogs, and porcine zona pellucida (PZP) an injectable contraceptive vaccine previously investigated for use in white-tailed deer.
FDA will retain regulatory authority over immobilizing agents used for wildlife management. APHIS currently holds INADs for propiopromazine HCl used in the tranquilizer trap device, and alpha-chloralose for nonlethal removal of problem birds. FDA is requesting APHIS close the INADs for these products also. Given the limited use of either of these products, it is unlikely that full new-animal drug authorizations will be obtained. Consequently, APHIS is evaluating alternatives through FDA and EPA that would allow continued use of alpha- chloralose by WS.
Wildlife Contraceptives—The next wildlife contraceptive likely to receive EPA registration is GonaCon, an immunocontraceptive vaccine based on GnRH. GonaCon is the first immunocontraceptive vaccine to provide multiple years of infertility following a single injection. The first product registration will be for use in female white-tailed deer. Data submission for EPA registration is expected by December 2008. In preparation for this registration, NWRC and Wildlife Services personnel are working closely with the Association of Fish and Wildlife Agencies to ensure the final label meets the needs of state game and fish management agencies.
GonaCon is currently being tested on a wide variety of wildlife species including other cervids, wild horses, prairie dogs, and gray squirrels. USDA APHIS may seek EPA registration of additional uses in the future.
Rodenticide and Avicide Use for Island Conservation
The NWRC Registration Unit and APHIS have been integrally involved in national, interagency efforts to eradicate rodents on islands for the conservation of critical habitats and the preservation of native flora and fauna. Work done by WS, the U.S. Fish and Wildlife Service (FWS), National Park Service (NPS), U.S. Geological Survey, and many other national and international organizations has demonstrated that removing introduced rodents from island ecosystems can benefit native organisms and birds. These efforts have led APHIS to submit three registration applications to EPA and one application to the Hawaii Department of Agriculture for applying anticoagulant rodenticides (diphacinone and brodifacoum) for the eradication of introduced rodents. EPA granted the first registration, for a diphacinone-based rodenticide, in June 2007. EPA registrations of two formulations of brodifacoum were granted in March 2008.
The Registration Unit worked closely with two rodent-eradication efforts conducted by WS Operations, one on a small island off St. Johns in the U.S. Virgin Islands and one on Grassy Key in Florida. Both of these efforts were conducted under Emergency Use Permits granted by EPA. The goal of the Virgin Islands effort was to prepare habitat for the reintroduction of the endangered Virgin Islands boa. The brodifacoum bait proposed for registration was hand broadcast at the maximum application rate. Rats were not observed on the island for at least six months. However, trapping efforts one year after application revealed that rats were once again on the island. Failure of this eradication effort may have been due to the complexity of the physical structure of the island (e.g., numerous crevices and cliff faces where bait was not adequately distributed) or because of reinvasion from the neighboring island 260 yards offshore. Scientists are currently collecting DNA samples from rodents in the treated area as well as on nearby islands to identify possible sources of reinvading rodents.
The Registration Unit has also assisted with the eradication of the recently introduced Gambian giant pouched rat in Florida. Because of poor containment by the pet trade, this rat became established on Grassy Key. The FWS, Florida Fish and Wildlife Conservation Commission, and Florida Department of Agriculture and Consumer Services were fearful of the impacts that the Gambian giant pouched rat could have on southern Florida and the entire gulf coast region if it became established on the Florida mainland.
Working with these agencies, NWRC helped obtain a quarantine emergency exemption from EPA to conduct an eradication effort using specially formulated zinc phosphide bait. Bait application for this eradication effort began in June 2007 and continues.
Rodenticide and Avicide Use for Agricultural Protection
Rodenticides continue to be a critical tool for the protection of agricultural resources. During FY07, the Registration Unit responded to requests from EPA for additional data for zinc phosphide and strychnine. The Registration Unit also responded to numerous requests for regulatory assistance from state agencies and WS. Many of the requests for assistance came from WS Operations personnel looking for help interpreting product labels to ensure that proposed applications were legal. However, state agriculture and pesticide agencies also requested label modification to meet growers’ needs and requested scientific review of registration application material for vertebrate pesticide products proposed for registration within their states.
All APHIS strychnine products are now officially reregistered with EPA. These strychnine products are restricted to subterranean baiting for pocket gophers. The final data requirement for re-registration, a product storage stability study, was completed and submitted to EPA in FY 2007 by the Registration Unit, in cooperation with the NWRC Analytical Chemistry Project and the Pocatello Supply Depot.
At the request of EPA, APHIS voluntarily cancelled its two inactive product labels that allowed aboveground baiting. With the exception of one Nevada registration, all aboveground uses of strychnine have been terminated.
The California Department of Food and Agriculture (CDFA) requested an amendment to the APHIS zinc phosphide concentrate label to include use with artichokes. CDFA provided all the data needed to ensure product efficacy and worker safety. APHIS submitted a label amendment request to EPA, and use of this product in artichokes was approved April 2008. In addition to this label modification, APHIS also submitted a request to EPA to allow use of this product in food and feed crops, including alfalfa, barley, dry beans, sugar beets, and wheat.
In FY 2007, the NWRC Registration Unit finished a multiyear cooperative study with a private rodenticide registrant, the NWRC Olympia Field Station, and the forest-products industry in the Pacific Northwest to develop a rodenticide product containing chlorophacinone for controlling mountain beavers in reforestation areas. The Registration Unit’s role in this project involved obtaining two Experimental Use Permits from EPA to conduct efficacy trials and trials looking at the economics of baiting techniques. In addition, the Registration Unit worked closely with the private rodenticide registrant to ensure a successful product registration. Through these efforts, the product received state registrations in Oregon and Washington.
*ATTENTION: Information contained in this website is provided for general information only.
All uses of pesticides must be registered by appropriate state and/or federal agencies before they can be sold, distributed, or applied. The information provided on these pesticide labels may not reflect all of the actual information, including precautions and instructions for use required in your specific state or locality. It is the responsibility of persons intending to use a pesticide to read and follow the label that has been approved for the particular state or locality in which the pesticide is to be used, and to comply with all federal, state, and local laws and regulations relating to the use of pesticides.
Mention of companies or commercial products at this website does not imply recommendation or endorsement by the U.S. Department of Agriculture over others not mentioned. Product names are mentioned solely to report factually on available data and to provide specific information. USDA neither guarantees nor warrants the standard of any product mentioned. The USDA labels provided on this website are not intended for distribution. Persons applying pesticides must abide by the label and labeling which comes with any pesticide product they use.
|
