contraceptive materials for wildlife and feral animals 

 deemed to be pests under the Federal Insecticide, 

 Fungicide and Rodenticide Act's definition of pest 

 species would be transferred to EPA, and that FDA 

 would retain regulation of contraceptives used in 

 companion animals, livestock, and zoo animals. In 

 conjunction with this 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. 



FDA will retain regulatory authority over immobilizing 

 agents used for wildlife management. APHIS cur- 

 rently holds INADs for propiopromazine HCI used in 

 the tranquilizer trap device, and alpha chloralose for 

 nonlethal removal of problem birds. FDA is request- 

 ing 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 — One wildlife contraceptive 

 likely to receive EPA registration is GonaCon, an immu- 

 nocontraceptive 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 during the winter of 2007-08. In prepara- 

 tion for this registration, NWRC and WS personnel are 

 working closely with the Association of Fish and Wild- 

 life 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 and may be registered for others 

 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. 

 Department of the Interior's U.S. Fish and Wildlife 

 Service (FWS), National Park Service (NPS), and 

 U.S. Geological Survey; and many other national 

 and international organizations has demonstrated 

 that removing introduced rodents from island 

 ecosystems can have beneficial effects on 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 

 July 2007. Registrations for the remaining products 

 are expected in 2007 and 2008. 



As a supplement to the body of work on rodent 

 eradication, the Registration Unit, in cooperation 

 with FWS, published a risk assessment for aerial 

 diphacinone applications to Hawaiian forests. 



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 6 months. However, trapping efforts 1 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 



44 Developing Methods 



