This chapter explores the conditions required for using the new testing strategy for regulatory purposes. It focuses on the federal agencies and identifies institutional outlooks and orientation—both tangible, such as budget and staffing, and intangible, such as leadership and commitment—that can determine the pace and degree to which the vision is incorporated into agency culture and practice. The chapter also addresses the fundamental issues related to the use and the validity of the new concepts, technologies, and resulting data for the specific purpose of developing federal regulations.
The committee’s vision anticipates continual change over the next 2-3 decades. Beyond the scientific and procedural considerations summarized in this chapter, the state of the economy, changing environmental conditions and social perspectives, and other dynamics that shape the political climate will influence legislative changes and federal budgets that, in turn, will determine the future of toxicity testing in the regulatory context.
Full realization of the vision depends on the promotion of new testing principles and methods in the scientific community at large. As in the past, some changes will originate outside the regulatory agencies and work their way into agency practice, and others will originate in the agencies and work their way into the larger scientific community. In both cases, far-reaching shifts in orientation and perception will be critical. For risk assessors and researchers, the shifts will be from familiar types of studies and established procedures involving overt effects in laboratory animals and cross-species extrapolation to new approaches that focus on how chemicals, both endogenous and exogenous, interact in