Environmental Assessment of Estraqua? (Estradiol Type A Medical Article) for American Eels in Recirculating Aquaculture Systems (RAS)

Novaeel, Inc., Halifax NS

Investigators

Abstract

RESEARCH & RELATED Other Project Information: Section 7 Project Summary/Abstract This Environmental Assessment project is required by the FDA Center for Veterinary Medicine to complete the Environmental Assessment technical section of the new animal drug application. This project will evaluate environmental risk factors based on the properties of and proposed use of INAD 012-884 (Type A Medicated Article, 0.1% estradiol (Estraqua®)) administered in feed (at a dosing rate of 5 ppm) to American eels (Anguilla rostrata) in a recirculating aquaculture system (RAS). The study will provide the basis for FDA CVM to make a regulatory conclusion, either a finding of no significant effects (FONSI) or an environmental impact statement (EIS).