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Product Registration Unit


Product Registration Unit  

John D. Eisemann, Technology Transfer Manager

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 291K 

Registration Program Support Activities 2008

New APHIS Pesticide Product Registrations—APHIS registered two new rodenticide products through the EPA in 2007 with the assistance of the U.S. Fish & Wildlife Service (FWS) and a nongovernmental organization. These products, “Brodifacoum-25W Conservation” (EPA Reg. No. 56228-36) and “Brodifacoum-25D Conservation” (EPA Reg. No. 56228-37), are intended to be used for conservation purposes, specifically the eradication of invasive rodents on islands and unmanned derelict ships. Hawaii granted a state registration for Diphacinone 50 Conservation in 2007, and WS and FWS conducted an eradication project on Mokapu Island in February 2008. Rodent monitoring on the island will continue for two years to ensure the eradication effort was successful. Alaska approved the registration of Brodifacoum 25W Conservation to conduct a rat eradication project on Rat Island in the Aleutian Islands in September 2008. These two new products, along with Diphacinone-50: Conservation” (EPA Reg. No. 56228-35) registered in June 2007, are vital tools in the efforts to protect native wildlife on islands from invasive rodents.

In addition to the new labels for rodent eradication using anticoagulant rodenticides, the NWRC Registration Unit assisted WS in obtaining an EPA Emergency Use Permit to use a new zinc phosphide formulation to eradicate Gambian pouch rats from Grassy Key in Florida. This project was the first eradication effort against the Gambian pouch rat in the United States and utilized special bait stations because the effort was conducted in a densely populated area.

The California Department of Food and Agriculture (CDFA) requested that APHIS modify the “Zinc Phosphide Concentrate label (EPA Reg. 56228-6) to help control California voles in artichoke fields. In a cooperative effort, the CDFA provided all of the data needed to ensure product efficacy and worker safety, and APHIS submitted a label amendment request to EPA in 2007 that was approved in March 2008. In addition to this label modification, APHIS 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.

Wildlife Contraceptives—NWRC is a world leader in the development of effective wildlife contraceptives. The first APHIS contraceptive positioned for registration with the EPA is GonaCon™, an immunocontraceptive vaccine based on gonadotropin-releasing hormone. GonaCon is the first immunocontraceptive vaccine to provide multiple years of infertility following a single injection. NWRC's Registration Unit will soon submit the registration application for controlling fertility in white-tailed deer to the EPA. The Registration Unit has also worked closely with NWRC scientists and cooperators to field test GonaCon in prairie dogs and tree squirrels. If successful, NWRC may seek EPA registrations for these species.

APHIS has two EPA Experimental Use Permits (EUPs) to test GonaCon in other cervid species, such as deer and elk. EPA approved an EUP in July 2007 for a study NWRC is conducting in cooperation with the U.S. National Park Service (NPS) at Point Reyes National Seashore in California. The purpose of the study is to evaluate the efficacy of GonaCon on fallow deer. EPA approved another EUP in November 2007 for NWRC to test GonaCon™ in elk in the RMNP. The testing of GonaCon for reproductive control of overabundant elk is one part of a study to manage elk population health and abundance in the RMNP. This study is a cooperative effort among NWRC, CSU, and the Colorado Division of Wildlife.

Predacide Petition Under Consideration with EPA In November 2007, the EPA sought public comment on a petition the agency received to cancel the registrations for sodium cyanide and sodium fluoroacetate for predator control. WS is authorized by Congress to manage a program to reduce human/wildlife conflicts, including depredations by livestock predators. Currently, WS uses sodium cyanide capsules in M-44 devices and sodium fluoroacetate (Compound 1080) in the livestock protection collar (LPC) as tools in an integrated wildlife damage management (IWDM) program, primarily to control predators impacting livestock production.

To provide input on the petition, APHIS assembled a task force to prepare a comprehensive WS response. The task force was led by APHIS WS Operational Support Staff and included representatives from WS Operations, USDA Agricultural Research Service, APHIS Policy and Program Development, The response submitted to EPA detailed the IWDM program, compliance and recordkeeping, WS use patterns of M-44s and LPCs, the economics of predator management, and human and pet health and safety as it relates to M-44 and LPC use. The NWRC Invasive Species and Technology Development (ISTD) Program, including the Registration Unit and the Economics Project, provided evaluations of the health and safety and economic impacts of M-44 and LPC use. APHIS expects an EPA decision on this petition by the end of 2008.


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