Developing BEs

A chemical-specific BE can be derived for many chemicals using existing PK information.  The BE derivation process includes:

• Compiling existing tolerable exposure reference values and the approaches used to calculate them
• Compiling and reviewing existing PK information available for translating exposure/intake (mg/kg/day or ppm in air) to internal dose metrics (blood or urine concentrations)
• Reviewing information on the mode of action (MOA) for each endpoint for which an exposure guidance value was derived
• Determining the best available biomarker and assessing whether existing biomarkers used in biomonitoring studies are interpretable
• Deriving the appropriate BE values (BE_POD, BE_RfD)
• Independent peer-review of the BE
• Publishing the BE dossier in the peer-reviewed literature
• Development of chemical-specific communications materials, including website materials

Additional information can be found in the Guidelines for the Derivation and Communication of BEs.