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Guidance and Technical Reports

This page contains downloadable guidance related to bioavailability.

You will need Adobe Reader to view some of the files on this page. See EPA's PDF page to learn more.

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)

Soil Dioxin Relative Bioavailability Assay Evaluation Framework (PDF) (17 pp, 351 K)

Guidance for Evaluating the Bioavailability of Metals in Soils for Use in Human Health Risk Assessment (PDF) (20 pp, 133 K)

Lead

Estimation of Relative Bioavailability of Lead in Soil and Soil-like Materials Using In Vivo and In Vitro Methods

These documents address 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)

Validation Assessment of In Vitro Lead Bioaccessibility Assay for Predicting Relative Bioavailability of Lead in Soils and Soil-like Materials at Superfund Sites (PDF) (14 pp, 114 KB) OSWER 9200.3-51, June 2009

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)(16 pp, 291 KB)

Arsenic

Relative Bioavailability Of Arsenic In Soils At 11 Hazardous Waste Sites Using An In Vivo Juvenile Swine Method

These documents address an in vivo swine bioavailability bioassay, which is a scientifically sound and feasible methodology for measuring relative bioavailability (RBA) of arsenic in soil and soil-like materials. The Office of Superfund Remediation and Technology Innovation (OSRTI) believes that the Regions should consider this method for quantitative use in site-specific risk assessments

Relative Bioavailability Of Arsenic In Soils At 11 Hazardous Waste Sites Using An In Vivo Juvenile Swine Method (PDF) (56 pp, 0.8 MB)
Appendices (PDF) (249 pp, 5.5 MB)

Compilation and Review of Data for Relative Bioavailability of Arsenic in Soil and Recommendations for Default Value for Relative Bioavailability

These documents identifed and evaluated literature relavent to estimating a relative bioavailability (RBA) value of arsenic in soil. Based upon the analysis and external independent peer review, the following conclusions have been determined: 1) Currently available research information suggests that an RBA of arsenic in soils can be expected to be less than 100%; 2) the upper percentile of US data results in a default RBA arsenic in soil value of 60%; 3) the default RBA for arsenic in soils should only be used if site-specific assessments for arsenic RBA are not feasible.

Transmittal Memo from Becki Clark to the Regions, dated December 31, 2012 (PDF) (2 pp, 390 KB)
Compilation and Review of Data on Relative Bioavailability of Arsenic in Soil (PDF) (58 pp, 776 KB)
Recommendations for Default Value for Relative Bioavailability of Arsenic in Soil (PDF) (4 pp, 38 KB)
Relative Bioavailability of Arsenic in an Asarco and a Hawaii Soil (PDF) (41 pp, 1.17 MB)
Relative Bioavailability of Arsenic in Barber Ochard Soils (PDF) (80 pp, 5.11 MB)
Relative Bioavailability of Arsenic in Two Soils from the Iron King Mine (PDF) (40 pp, 636 KB)
Relative Bioavailability of Arsenic in NIST SRM 2710 (Montana Soil) (PDF) (45 pp, 1.53 MB)
Relative Bioavailability of Arsenic in a Mohr Orchard Soil (PDF) (47 pp, 521 KB)
Relative Bioavailability of Arsenic and Vanadium in Soil from a Superfund Site in Palestine, Texas (PDF) (62 pp, 3.68 MB)
Bioavailability Committee Mineralogical Report (PDF) (9 pp, 423 KB)

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