Issues Regarding the Use of Sedatives in Fisheries and the Need for Immediate‐Release Options

Abstract

AbstractThe lack of an immediate‐release sedative (i.e., one for which no postsedation holding or withdrawal period is required) jeopardizes fish and fisheries research and poses considerable risk to those involved in aquatic resource management and the operation of public hatcheries and commercial fish farms. Carbon dioxide may be used as an immediate‐release sedative, but it is slow‐acting and difficult to apply uniformly and effectively. Tricaine methanesulfonate (MS‐222) is easier to apply but requires a 21‐d withdrawal period. The lack of an immediate‐release sedative approved by the U.S. Food and Drug Administration (FDA) is a consequence of numerous factors, including the complexities of the approval process, the substantial human and monetary resources involved, and the specialized nature of the work. Efforts are currently underway to demonstrate the safety and effectiveness of benzocaine‐ and eugenol‐based products as immediate‐release sedatives. However, pursuing approvals within the current framework will consume an exorbitant amount of public and private resources and will take years to complete, even though both compounds are “generally recognized as safe” for certain applications by the FDA. We recommend using risk management–based approaches to increase the efficiency of the drug approval process and the availability of safe and effective drugs, including immediate‐release sedatives, for use in the fisheries and aquaculture disciplines.