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.