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Guidance and Technical Reports
This page contains downloadable guidance related to bioavailability.
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Guidance for Evaluating the Bioavailability of Metals in Soils for Use in Human Health Risk Assessment
This guidance document provides: 1) a recommended process for deciding when to collect site-specific information on the oral bioavailability of metals in soils for use in human health risk assessments; 2) a recommended process for documenting the data collection, analysis, and implementation of a validated method that would support site-specific estimates of oral bioavailability; and 3) general criteria that EPA normally will use to evaluate whether a specific bioavailability method has been validated for regulatory risk assessment purposes.
Transmittal Memo from James E. Woolford to the Regions, dated July 3, 2007 (PDF) (4 pp, 1 MB)
Guidance for Evaluating the Bioavailability of Metals in Soils for Use in Human Health Risk Assessment (PDF) (20 pp, 133 K)
Estimation of Relative Bioavailability of Lead in Soil and Soil-like Materials Using In Vivo and In Vitro Methods
This document addresses an in vivo swine bioavailability bioassay and an in vitro bioaccessibility assay, which generally are scientifically sound and feasible methodologies for predicting the relative bioavailability (RBA) of lead in soil and soil-like materials. The Office of Superfund Remediation and Technology Innovation (OSRTI) believes that the Regions normally should consider these particular test methodologies to be validated methodologies for quantitative use in site-specific risk assessments.
Transmittal Memo from James E. Woolford to the Regions, dated July 3, 2007 (PDF) (7 pp, 2 MB)
Entire Document (PDF) (386 pp, 4.9 MB)
Main Text, Tables and Figures (PDF) (74 pp, 583 K)
Appendices (PDF) (312 pp, 4.2 MB)
Standard Operating Procedure for an In Vitro Bioaccessibility Assay for Lead in Soil
The purpose of this standard operating procedure (SOP) is to define the proper analytical procedure for the validated in vitro bioaccessibility assay for lead in soil as described in Estimation of Relative Bioavailability of Lead in Soil and Soil-like Materials Using In Vivo and In Vitro Methods (EPA, 2007). The SOP also describes the typical working range, the limits of the assay, and any potential interferences.
Standard Operating Procedure for an In Vitro Bioaccessibility Assay for Lead in Soil (PDF)(9 pp, 159 Kb)