06-2436. A Framework for Assessing Health Risks of Environmental Exposures to Children

AGENCY:

Environmental Protection Agency.

ACTION:

Notice of public comment period.

SUMMARY:

The U.S. Environmental Protection Agency (EPA) is announcing a 45-day public comment period for the external review draft document titled, “A Framework for Assessing Health Risks of Environmental Exposures to Children” (EPA/600/R-05/093A). The draft document was prepared by the National Center for Environmental Assessment (NCEA) within EPA's Office of Research and Development (ORD).

For external scientific peer review, EPA has hired Eastern Research Group, Inc. (ERG) to convene an independent panel of experts and organize and conduct an external peer-review workshop. The date and location for the external peer-review workshop will be announced in a separate Federal Register notice, once that information is obtained by EPA. The public comment period and the external peer-review workshop are separate processes that provide opportunities for all interested parties to comment on the document. In addition to consideration by EPA, all public comments submitted in accordance with this notice will also be forwarded to ERG for the external peer-review panel prior to the workshop.

EPA is releasing this external review draft document solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This draft document has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy or determination.

DATES:

The 45-day public comment period begins March 14, 2006, and ends April 28, 2006. Technical comments should be in writing and must be received by EPA by April 28, 2006.

ADDRESSES:

The draft document and EPA's peer-review charge are available primarily via the Internet on the National Center for Environmental Assessment's home page under the Recent Additions and Publications menus at http://www.epa.gov/​ncea. A limited number of paper copies are available from the Technical Information Staff, NCEA-W; telephone: [phone]; facsimile: 202-565-0050. If you are requesting a paper copy, please provide your name, mailing address, and the document title, “A Framework for Assessing Health Risks of Environmental Exposures to Children” (EPA/600/R-05/093A).

Comments may be submitted electronically via http://www.regulations.gov, by mail, by facsimile, or by hand delivery/courier. Please follow the detailed instructions as provided in the SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT:

For information on the public comment period, contact the OEI Docket; telephone: [phone]; facsimile: 202-566-1753; or e-mail: [e-mail].

If you have questions about the document, please contact the Technical Information Staff, National Center for Environmental Assessment, U.S. Environmental Protection Agency, Washington, DC 20460; telephone: [phone]; facsimile: 202-565-0050; or e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Information About the Document

Over the past decade, there has been a dramatic increase in the recognition of, and public health concern for, the vulnerability of children to exposure to environmental agents. Children have unusual patterns of exposure and have vulnerabilities to chemical agents that are quite distinct from those of adults, and thus require special consideration in risk assessment. Children often have disproportionately higher exposures to certain environmental toxicants because, pound-for-pound of body weight, children have higher food and water intake and breathe more air than adults. Metabolic pathways in the young, especially in the first few months after birth, are immature, and the ability to detoxify environmental agents is different from that of adults. In addition, behavior and activity patterns of children often magnify their exposures. These factors imply that children are likely to have more substantial exposures than adults to certain environmental agents. This document attempts to organize and present current knowledge and practices in a programmatic framework for assessing human health risks from exposures to environmental agents from prior to conception through adolescence. It describes this framework within the current Agency risk assessment paradigm, and includes problem formulation, analysis and risk characterization as discrete steps in the process. Moreover, this document focuses on mode of action as a context for considering the toxicokinetic and toxicodynamic differences between children and adults, and considers approaches for risk assessment in the context of uncertainty and variability in exposure and critical windows of development.

II. How To Submit Technical Comments to the Docket

Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2006-0134, by one of the following methods:

• http://www.regulations.gov: Follow the on-line instructions for submitting comments.
• E-mail: [e-mail].
• Fax: [phone].
• Mail: Office of Environmental Information Docket (Mail Code: 2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-566-1752.
• Hand delivery/courier: The Office of Environmental Information (OEI) Docket is located in the Headquarters EPA Docket Center (EPA/DC), EPA West Building, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is 202-566-1744, and the telephone number for the OEI Docket is 202-566-1752; facsimile: 202-566-1753; or e-mail: [e-mail]. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

If you provide technical comments by mail or hand delivery/courier, please submit one unbound original with pages numbered consecutively, and three copies of the comments. For attachments, provide an index, number pages consecutively with the comments, and submit an unbound original and three copies.

Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-2006-0134. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through http://www.regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket, visit the EPA Docket Center home page at http://www.epa.gov/​epahome/​dockets.htm.

Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute in the EPA Headquarters Docket Center. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov, or in hard copy at the OEI Docket in the EPA Headquarters Docket Center.

Dated: March 7, 2006.

George W. Alapas,

Acting Director, National Center for Environmental Assessment.