Epidemiological studies
The use of available data from the positive epidemiological studies in the risk assessment is encouraged. Data derived fiom human clinical studies, should also be utilized in the hazard identification step, as well as, other steps. However, clinical and epidemiological data are unlikely to be available for most chemicals. In addition, negative epidemiological data may be difficult to interpret for risk assessment purposes because the statistical power of most epidemiological studies is inadequate to detect effects at relatively low levels in human populations.
Finally, a positive data indicates that an adverse effect has already occurred thus, risk management decisions should not be delayed pending the development of epidemiological studies. Epidemiological studies fiom which data for risk assessment are derived should be based on recognized standardized protocols.