UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OFFICE OF
SOLID WASTE AND EMERGENCY
RESPONSE
OSWERNo. 9285.7-02 EP
August 16, 2004
MEMORANDUM
SUBJECT: "Supplemental Guidance for Dermal Risk Assessment," Part E of Risk Assessment
Guidance for Superfund, Human Health Evaluation Manual
(Volume I)
FROM: Michael B. Cook, Director /s/
Office of Superfund Remediation and Technology Innovation
TO: Superfund National Policy Managers, Regions 1-10
Regional Toxics Integration Coordinators (RTICs), Regions 1-10
PURPOSE
This memorandum transmits the "Supplemental Guidance for Dermal Risk Assessment" to
the Regions for use in risk assessments at Superfund sites. The memorandum describes intended
uses of this guidance and clarifies how additional information and data, relevant to the use of this
guidance, will be made available by the U.S. Environmental Protection Agency (EPA).
BACKGROUND
This guidance is the fifth annex of the Risk Assessment Guidance for Superfund (RAGS),
Volume I, addressing human health risk at Superfund sites. Parts A, B, C and D of Volume I
addressed other aspects of human health risk. This dermal risk guidance was developed by a
workgroup composed primarily of toxicologists and risk assessors from Regional Superfund
programs, with additional participation from the Office of Research and Development (ORD) and
the Office of Solid Waste and Emergency Response (OSWER). This guidance received internal
EPA peer review in May 1997 and external peer review in January 1998 and again in January 2000.
In December 2001 this guidance was released for public review and comment and placed on the
following EPA Superfund risk assessment internet website:
http://www.epa.gov/oerrpage/superfund/programs/risk/ragse/.
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Changes in response to the public comments received have been made in the final guidance,
dated July 2004. This dermal risk guidance makes numerous references to ORD's 1992 Dermal
Exposure Assessment (DEA) and is considered an extension of the principles and methods
identified in DEA for risk assessments for Superfund sites.
IMPLEMENTATION
Human dermal exposures (and risk) to contaminated soil and water are assessed by separate
methodologies in the guidance. Additional information is provided in the guidance describing these
methodologies and associated assumptions and variables.
Some of the statutory provisions described in this memorandum or in the guidance released
by this memorandum contain legally binding requirements. However, neither this memorandum
nor the guidance substitute for those provisions or regulations. Nor is this memorandum or
guidance document a regulation itself. Thus, it cannot impose additional legally-binding
requirements upon EPA, States, Tribes, other federal agencies, or the regulated community. In
some instances relating to a particular situation or circumstance this might not be the most relevant
guidance to follow. Any decisions regarding the selection of a particular remedial or other response
action on a CERCLA (Comprehensive Environmental Response, Compensation and Liability Act of
1980, as amended) site will be made based on the statute and regulations, and EPA decision-makers
retain the discretion to adopt approaches on a case-by-case basis that may differ from this guidance
where appropriate. In the future, EPA may modify this guidance.
FUTURE DEVELOPMENTS
The EPA Superfund Program and this workgroup will continue to track current
developments of the science of human dermal risk assessments. ORD is also funding research
which may ultimately allow additional contaminants to be addressed by the water model with
acceptable levels of confidence. The EPA Superfund Program will post such developments on its
above-identified website along with this guidance.
In addition, the methodology for addressing human dermal exposures to soil contamination
contains "default" assumptions (Exhibit 3-4 of the guidance) on the fraction of a contaminant in soil
which is absorbed into the body. The dermal workgroup will continue to assess peer-reviewed
literature, including any literature brought to the workgroup's attention by outside parties, to
determine when these default assumptions should be changed. Rather than revising the guidance, a
current list of acceptable peer-reviewed dermal soil absorption values for soil will be posted on the
above-identified EPA Superfund risk assessment website. Users of this guidance or other interested
parties may bring such peer-reviewed values and other relevant information to the attention of the
dermal workgroup by contacting a member of the workgroup. This website will contain a current
list of the dermal workgroup members, their telephone numbers and e-mail addresses. Please
contact a member of the workgroup with any questions about this guidance.
Future users of this guidance are advised to periodically visit this website to ensure that they
have current information relating to this dermal risk guidance, including the effective predictive
domain (EPD) for the water pathway, the dermal soil absorption values, and contact information for
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the workgroup for implementation questions.
If you have questions about the information presented in this memorandum, please contact
Dave Crawford at (703) 603-8891, or by e-mail at crawford.dave@epa.gov.
Attachment
Risk Assessment Guidance for Superfund, Volume I: Human Health Evaluation Manual (Part
E, Supplemental Guidance for Dermal Risk Assessment, OSWER 9285.7-02EP)
cc: Nancy Riveland, Superfund Lead Region Coordinator, USEPA Region 9
Eric Steinhaus, USEPA Region 8
NARPM Co-Chairs
OSRTI Managers
Jim Woolford, FFRRO
Debbie Dietrich, OEPPR
Robert Springer, Senior Advisor to OSWER AA
Matt Hale, OSW
Cliff Rothenstein, OUST
Linda Garczynski, OBCR
Dave Kling, FFEO
Susan Bromm, OSRE
Earl Salo, OGC
Charles Openchowski, OGC
Joanna Gibson, OSRTI Documents Coordinator
Dermal Workgroup Members
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