Wildlife Contraceptives: A Regulatory Hot Potato

Abstract

Changing cultural values and increasing urbanization in the United States are curtailing traditional wildlife management tools used to effectively manage conflicts between human and wildlife populations. Because of this trend, the USDA Wildlife Services, National Wildlife Research Center (NWRC) began developing wildlife contraceptives in 1991. Since that time, NWRC scientists have steadily worked toward the goal of developing and registering contraceptive products that are practical to use, safe for the treated animal, and present little risk to humans, nontarget animals, and the environment. Working cooperatively with Innolytics, LLC, OvoControl G™ was recently registered for reducing the hatchability of Canada goose eggs. Another product developed by the NWRC, the single-shot GonaCon™ Immunocontraceptive Vaccine is poised to begin the registration process. A third product, DiazaCon™, soon will be tested for field efficacy and should begin the registration process within the year. Between 1996 and the present, the regulatory agency responsible for wildlife contraceptives has been the Food and Drug Administration, Center for Veterinary Medicine (CVM). Working under this premise, the NWRC has progressed toward fulfilling CVM’s regulatory requirements by conducting field efficacy studies and a target animal safety study. NWRC explored various registration options with the CVM, and also with the USDA APHIS Center for Veterinary Biologics (CVB). Through this process, it became clear that wildlife contraceptives were incompatible with CVM’s regulatory process, and outside the regulatory authority of CVB. In response, CVM and the U.S. Environmental Protection Agency (EPA) negotiated an agreement on contraceptive uses. The EPA will assume regulatory authority of contraceptives used for wildlife and feral animals. The CVM will retain authority over all uses in captive animals including livestock, companion animals, and zoo animals.