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Overview of the Standing Operating Procedures (SOP) for the Development of Provisional Advisory Levels (PALs)...

by Danny Young, Cheryl B Bast, Carol S Wood, Femi Adeshina, Robert H Ross
Publication Type
Journal
Journal Name
Inhalation Toxicology
Publication Date
Page Numbers
1 to 11
Volume
21

Provisional Advisory Levels (PALs) are concentrations in air and drinking water for priority toxic chemicals. This article summarizes the Standing Operating Procedures (SOPs) currently in place for the data-driven development of chemical-specific PALs. To provide consistency and transparency, and to avoid faults of arbitrariness, SOPs were developed for guidance in deriving PAL values. The SOPs for PAL development focus on: 1) data acquisition and analysis, 2) identification of a chemical-specific critical effect, 3) selection of a quantitative point-of-departure (POD), 4) uncertainty analysis and adjustments, 5) exposure duration adjustment and extrapolation, 6) identification of special concerns and issues, and 7) verification, documentation and dissemination of PALs. To avoid uncompromising rigidity in deriving PAL values and to allow for incorporation of new or refined methodologies, the overall procedure is fluid and subject to modification. The purpose of this publication is to provide a summary of these SOPs.