Document ID: EPA-HQ-ORD-2006-0223-0002
Agency: epa
Document Type: Notice
Title: Considerations for Developing Alternative Health Risk Assessment Approaches for Addressing Multiple Chemicals, Exposures and Effects; External Review Draft
Posted Date: 2006-03-31T15:45:37Z

[Federal Register: March 31, 2006 (Volume 71, Number 62)]
[Notices]               
[Page 16306-16307]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr06-66]                         

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8052-5; Docket ID No. EPA-HQ-ORD-2006-0223]

 
Considerations for Developing Alternative Health Risk Assessment 
Approaches for Addressing Multiple Chemicals, Exposures and Effects; 
External Review Draft

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: EPA is announcing a 45-day public comment period for the draft 
document titled, ``Considerations for Developing Alternative Health 
Risk Assessment Approaches for Addressing Multiple Chemicals, Exposures 
and Effects'' (EPA/600/R-06/013A). The draft document was prepared by 
the National Center for Environmental Assessment (NCEA) within EPA's 
Office of Research and Development.
    EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality 
guidelines. This document has not been formally disseminated by EPA. It 
does not represent and should not be construed to represent any Agency 
policy or determination. EPA will consider any public comments 
submitted in accordance with this notice when revising the document.

DATES: The 45-day public comment period begins March 31, 2006, and ends 
May 15, 2006. Technical comments should be in writing and must be 
received by EPA by May 15, 2006.

ADDRESSES: The draft document, ``Considerations for Developing 
Alternative Health Risk Assessment Approaches for Addressing Multiple 
Chemicals, Exposures and Effects,'' is available primarily via the 
Internet on the NCEA home page under the Recent Additions and the Data 
and Publications menus at http://www.epa.gov/ncea.

    A limited number of paper copies are available from Ms. Donna 
Tucker, Technical Information Manager, NCEA-Cincinnati; telephone: 513-
569-7257; facsimile: 513-569-7916; e-mail: tucker.donna@epa.gov. If you 
are requesting a paper copy, please provide your name, your mailing 
address, and the document title, ``Considerations for Developing 
Alternative Health Risk Assessment Approaches for Addressing Multiple 
Chemicals, Exposures and Effects,'' and its EPA publication number, 
EPA/600/R-06/013A.
    Comments may be submitted electronically via http://www.regulations.gov
, by mail, by facsimile, or by hand delivery/

courier. Please follow the detailed instructions provided in the 
SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the public comment 
period, contact the Office of Environmental Information Docket; 
telephone: 202-566-1752; facsimile: 202-566-1753; or e-mail: 
ORD.Docket@epa.gov.

    For technical information, contact Linda K. Teuschler, NCEA-
Cincinnati; telephone: 513-569-7573; facsimile: 513-487-2539; or e-
mail: teuschler.linda@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Information About the Document

    In EPA's 2003 ``Framework for Cumulative Risk Assessment,'' 
cumulative risk assessment is defined as the evaluation of risks from 
exposures to multiple chemicals and other stressors, and having a 
population focus rather than a source-to-receptor focus. Several 
reports and environmental justice concerns published over the past 11 
years have highlighted the importance of estimating cumulative risks. 
EPA has published several guidance documents dealing with specific 
aspects of cumulative risk, such as chemical mixture risk assessment, 
planning and scoping, stakeholder involvement, and the toxicity from a 
mixture of pesticides sharing a common mode of action. This draft 
document is one contribution to EPA's efforts to address issues related 
to cumulative health risk assessment.
    Existing EPA guidance addresses some of the combination aspects of 
cumulative risk, but none addresses all of the multiples included in 
this report, such as consideration of the composite impact of multiple 
health effects. Among the distinctive new approaches are those for 
grouping chemicals based on exposure characteristics and toxic 
endpoints, multi-route combination of relative potency factors, 
integration of categorical regression modeling of multiple effects with 
additivity approaches, and the emphasis on the iteration and 
collaboration between exposure assessment and dose-response assessment 
to ensure compatible and relevant information. Major findings and 
conclusions in this document are as follows:
     This draft report provides a set of approaches that deal 
with certain complications in cumulative risk assessment, specifically 
those caused by multiple chemicals, exposures and effects, including 
toxicological interactions and environmental

[[Page 16307]]

transformations of mixture component chemicals.
     The scope is focused on the evaluation of health risks 
from exposures to multiple chemicals, including multiple exposure 
routes and times as well as multiple health endpoints.
     Areas of cumulative health risk assessment emphasized in 
this report can often be performed with existing information.
     Exposure and toxicity characterizations of mixtures are 
strongly dependent on mixture composition (chemicals and 
concentrations) and timing of exposures and health effects.
     Qualitative and semiquantitative approaches provided can 
simplify the number of potential combinations of chemicals, exposures, 
and effects to make the cumulative health risk assessment more 
feasible.

II. How to Submit Technical Comments to http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2006-
0223 by one of the following methods:
     http://www.regulations.gov: Follow the on-line 

instructions for submitting comments.
     E-mail: ORD.Docket@epa.gov.
     Fax: 202-566-1753.
     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; 
facsimile: 202-566-1753.
     Hand Delivery: The Office of Environmental Information 
(OEI) Docket in the EPA Headquarters Docket Center, Room B102, EPA West 
Building, 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: 
ORD.Docket@epa.gov. 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 comments in writing, 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-
2006-0223. 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 homepage 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. 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 27, 2006.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
 [FR Doc. E6-4746 Filed 3-30-06; 8:45 am]

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