Risk-MaPP and ADEs

Now that Risk-MaPP has been out for 6 months and industry is beginning to incorporate the principles into their systems for managing the risk of cross contamination, companies are trying to understand the importance of developing ADEs (acceptable daily exposure) for their products.  ADEs are the cornerstone of this risk-based approach because the ADEs bring scientific justification into the process.  ADEs are developed by toxicologists based on data from clinical studies, package inserts, etc.  Some companies look to use the OEL (operator exposure limit) or a derivative of the OEL in place of the ADE.  Caution needs to be taken as OELs are based on workers which are assumed to be healthy working age adults most likely with inhalation as the primary mode of exposure whereas ADEs are set to be protective of all sub-populations by any route.

What issues have you found?  Please share.

Please visit the FAQ document on the Risk-MaPP resource page for more information on the use of ADEs.

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