E8-14623. Concepts, Methods, and Data Sources for Cumulative Health Risk Assessment of Multiple Chemicals, Exposures, and Effects: A Resource Document

AGENCY:

Environmental Protection Agency (U.S. EPA).

ACTION:

Notice of Availability.

SUMMARY:

The U.S. EPA announces the availability of a final document entitled, “Concepts, Methods, and Data Sources for Cumulative Health Risk Assessment of Multiple Chemicals, Exposures, and Effects: A Resource Document” (EPA/600/R-06/013F), which was prepared by the National Center for Environmental Assessment (NCEA) within the U.S. EPA's Office of Research and Development (ORD).

This document represents a collaborative effort between the U.S. EPA and the U.S. Department of Energy (U.S. DOE) that is designed to serve as an interim resource between U.S. EPA's 2003 “Framework for Cumulative Risk Assessment” (EPA/630/P-02/001F) and future documents on approaches and guidance to cumulative risk assessment. The document provides concepts, methods, and data sources for consideration and possible use in the conduct of a cumulative risk assessment. Specifically, the document focuses on two areas: (1) Initiating factors for a cumulative risk assessment, with procedures for data collection and organization, and (2) technical approaches for assessing human health risks associated with a subset of cumulative risk issues (i.e., multiple chemicals, exposures, and effects). Overall, this document demonstrates the feasibility of including combinations of chemicals, exposures, effects and their interactions into a cumulative risk assessment and is meant to assist with the conduct of multi-chemical, population-focused assessments.

This document has undergone review within the U.S. EPA, independent external peer review by a panel of scientific experts, and it has also benefited from a 45-day public comment period. However, it has not undergone the scrutiny required of a guidance document and, thus, does not represent U.S. EPA policy.

DATES:

This document will be available on or about June 26, 2008.

ADDRESSES:

The document will be available electronically through the National Center for Environmental Assessment (NCEA) Web site at http://www.epa.gov/​ncea. A limited number of paper copies will be available from the U.S. EPA's National Service Center for Environmental Publications (NSCEP); P.O. Box 42419; Cincinnati, OH 45242; [phone] (telephone); [phone] (facsimile); [e-mail]. Please provide your name, your mailing address, the title and the EPA number of the requested publication.

FOR FURTHER INFORMATION CONTACT:

Linda K. Teuschler, Project Leader, NCEA-Cin; 26 W. Martin Luther King Dr. (A-G20); Cincinnati, OH 45268; [phone] (telephone); [phone] (fax); [e-mail].

SUPPLEMENTARY INFORMATION:

The U.S. EPA's 2003 “Framework for Cumulative Risk Assessment” and earlier reports from the 1990s on the initial planning and scoping phase needed to conduct a cumulative risk assessment laid a broad foundation for continued development of cumulative risk approaches. The 2003 Framework describes some basic considerations for conducting a cumulative risk assessment and outlines four areas of population vulnerability: Susceptibility or sensitivity, differential exposure (e.g., living in close proximity to pollutant sources), differential preparedness (e.g., lack of disease immunizations), and differential ability to recover from exposures. Since 1986, U.S. EPA technical and guidance documents have been published that address chemical mixture risk assessments which can be used for cumulative risk assessment, but additional research has been needed to address chemical mixtures in combination with multiple exposures and effects.

In February 2001, the U.S. EPA began collaborating with the U.S. DOE in an effort to collect data and develop methods for use in cumulative risk assessments. This present document, “Concepts, Methods, and Data Sources for Cumulative Health Risk Assessment of Multiple Chemicals, Exposures, and Effects: A Resource Document,” is the final product of that effort. It further develops the knowledge base for conducting cumulative risk assessments by providing details regarding the evaluation of the human health and population aspects of cumulative risk assessment and by introducing practical ideas for addressing multiple chemicals, exposures, and effects.

The U.S. EPA released the external review draft in March 2006 for a 45-day public comment period (see 71 FR 16306-16307, March 31, 2006; Docket ID No. EPA-HQ-ORD-2006-0223). The draft received an independent peer review conducted by the Eastern Research Group under U.S. EPA contract number 68-C-02-060. The peer review included a two-day workshop in May 2006 and featured an external panel of scientific reviewers (see 71 FR 26365-26366, May 4, 2006; Docket ID No. EPA-HQ-ORD-2006-0223).

Dated: June 20, 2008.

Rebecca Clark,

Acting Director, National Center for Environmental Assessment.