Fenbendazole in PheasantsHuman Food Safety (Tissue Residue) Study Study Number 2010-280-HFS ADR Number 280PROJECT SUMMARYFenbendazole (Safeguard(R)) is a highly-effective benzimidazole-class anthelmintic that iscommonly used for the control of nematodes, tapeworms and trematodes that infect severaldomestic animal species in the United States. Fenbendazole has been reported to be effectiveagainst parasites that commonly infect game birds that are raised on commercial propagationfarms; however, it is not currently approved for game birds in the United States. Ring-neckedpheasants raised on propagation farms can be routinely infected with Heterakis gallinae (cecalworm), Syngamus trachea (gapeworm) and other parasitic worms that are susceptible tofenbendazole treatment. Depending on the severity of the infection, morbidity and mortality canbe quite high. The purpose of this study is to determine the tissue residues of fenbendazole inring-necked pheasants fed a diet containing approximately 100 ppm fenbendazole. Birds will bereared to 11 to 12 weeks of age on non-medicated commercial game bird diets. Group 1 (controlbirds) will continue to be fed the non-medicated (basal) diet. Birds in Group 2 will be fed 100ppm (90.4g/ton) fenbendazole added to the basal diet from days 0 to 7. On Day 7 thefenbendazole-containing feed will be removed and replaced with the basal diet. A designatednumber of birds from both groups will be humanely euthanized at 6-8, 12, 24 and 48 hoursfollowing fenbendazole withdrawal. Liver and muscle tissues will be removed from the birds ateach time point according to SOP, quickly frozen and stored at -80 C until tissues have beencollected from all study animals. The tissues will be shipped by overnight express to theanalytical laboratory at the University of California, Davis. Tissues will be analyzed forfenbendazole residues using the established regulatory method. The data obtained from thisstudy will be utilized to establish a withdrawal time for fenbendazole in pheasants. This studywill be considered pivotal.
. Fenbendazole will be fed to pheasants at a proposed treatment dose of 100 ppm in feed. Liver and muscle tissues will be harvested at 6-8, 12, 24 and 48 hours following withdrawal and analyzed for fenbendazole residues. This information will be used by the FDA/CVM to establish a withdrawal time for fenbendazole in pheasants.