Developmental toxicity testing over the last three decades has provided considerable data that have been used by regulatory agencies to set standards and to regulate exposures. As part of a larger guidelines effort, the Environmental Protection Agency (EPA) published guidelines for developmental toxicity risk assessment, first in 1986 and again in 1991. This was the first guidelines developed to describe a consistent approach for noncancer and nonmutagenic risk assessment. This chapter focuses on the risk assessment process used for developmental toxicity by EPA, although the guidelines represent a consensus document within the field of developmental toxicology. Three major components are discussed: hazard identification/dose-response evaluation, exposure assessment, and risk characterization.