The changing regulatory environment: EPA registration of a new marine antifoulant active ingredient

Abstract

Abstract Obtaining Environmental Protection Agency (EPA) registration for a new marine antifoulant is a challenging process which can take at least 3–5 years. Increasing regulatory, environmental, and product safety standards have significantly increased the time and money required to develop a new antifoulant and this trend is likely to continue. Three other developments have also affected the registration process. EPA's Special Review of organotin antifoulants and the Organotin Antifoulant Paint Control Act of 1988 raised the level of scrutiny on antifoulants. EPA's Registration Program has resulted in a significant shift of resources and priorities. The newly instituted Reduced-risk Pesticide Program may afford applicants the option of demonstrating lower risk compared to existing technologies and obtaining expedited review. This paper reviews our experience in registering a new antifoulant, the registration requirements, and the impact of these other factors on the registration process. EPA registration of 4, 5-dichloro-2- n -octyl-4-isothiazolin-3-one as a marine antifoulant was granted in February 1994.