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Risk Assessment

Guidelines for Reproductive Toxicity Risk Assessment

These Guidelines describe the procedures that EPA follows in using existing data to evaluate the potential toxicity of environmental agents to the human male and female reproductive systems and to developing offspring. These Guidelines focus on reproductive system function as it relates to sexual behavior, fertility, pregnancy outcomes, and lactating ability, and the processes that can affect those functions directly. Included are effects on gametogenesis and gamete maturation and function, the reproductive organs, and the components of the endocrine system that directly support those functions. These Guidelines concentrate on the integrity of the male and female reproductive systems as required to ensure successful procreation. They also emphasize the importance of maintaining the integrity of the reproductive system for overall physical and psychologic health. The Guidelines for Developmental Toxicity Risk Assessment (U.S. EPA, 1991) focus specifically on effects of agents on development and should be used as a companion to these Guidelines.
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