Risk assessment policy for evaluating reproductive system toxicants and the impact of responses on sensitive populations

Risk assessment policy for evaluating environmental chemicals for their potential to produce reproductive system failures is similar to policy for evaluating cancer-causing effects. The objective of reproductive system risk assessment is to expand on the test standards that primarily focus on fertility endpoints and birth defects by using mechanism-of-action studies and quantitative risk assessment methods. An understanding of the sensitivity of reproductive system insult between animal species and from animal models to man is critical to developing risk assessment policy and test standards. The reproductive process is complex and involves a number of maturation and sex cell development processes. Sensitivity to insult varies throughout this process, especially during, (1) the development of the conceptus, sperm and ova, (2) fertilization, (3) implantation, and (4) puberty. Reproductive failure has many causes and clinical effects. Risk assessment policy is directed toward reducing the uncertainty associated with the cause by providing a guide to understanding how dose, duration, and characteristics of the reproductive toxicant affect the reproductive process.