[Federal Register Volume 74, Number 169 (Wednesday, September 2, 2009)]
[Notices]
[Pages 45437-45438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21194]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2009-0605; FRL-8951-7]


Notice of Availability of the External Peer Review Draft of 
Recommended Toxicity Equivalency Factors (TEFs) for Human Health Risk 
Assessments of Dioxin and Dioxin-Like Compounds

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of document availability for public comment.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing a 30-
day public comment period for the external peer review draft of 
``Recommended Toxicity Equivalency Factors (TEFs) for Human Health Risk 
Assessments of Dioxin and Dioxin-Like Compounds,'' a draft guidance 
document. An EPA contractor for external peer review will convene a 
panel of experts and will organize and conduct an independent expert 
external peer review meeting to review the draft document. All comments 
received by the closing date of October 2, 2009 will be shared with the 
external peer review panel for their consideration. Comments received 
after the close of the comment period may be considered by EPA when it 
finalizes the document. This draft guidance document does not represent 
and should not be construed to represent any EPA policy, viewpoint, or 
determination. Members of the public may obtain the draft document from 
http://www.regulations.gov; or http://www.epa.gov/raf/hhtefguidance; or 
from Seema Schappelle via the contact information below. The public 
comment period and external peer review are separate processes that 
provide opportunities for all interested parties to comment on the 
document.
    The external expert peer review will be conducted by letter and 
open teleconference in the fall 2009 time frame. The panel may consider 
public comments received in the official public docket for this 
activity under docket ID number EPA-HQ-ORD-2009-0605. The draft 
document is available at http://www.epa.gov/raf/hhtefguidance. In 
preparing a final document, EPA intends to consider the public comments 
submitted to EPA's docket during the public comment period and the 
comments and recommendations from the external peer reviewers.
    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 the 
EPA. It does not represent and should not be construed to represent any 
Agency policy or determination.

DATES: All comments received by October 2, 2009 will be shared with the 
external peer review panel for their consideration. Comments received 
beyond that time may be considered by EPA when it finalizes the 
documents.

ADDRESSES: The draft document is available electronically through the 
EPA Office of the Science Advisor's Web site at: http://www.epa.gov/raf/hhtefguidance.
    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2009-
0605, by one of the following methods:
     Online at: http://www.regulations.gov; Follow the on-line 
instructions for submitting comments.
     E-mail: [email protected].
     Mail: ORD Docket, Environmental Protection Agency, 
Mailcode: 28221T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center (EPA/DC), Room 3334, EPA 
West Building, 1301 Constitution Avenue, NW., Washington, DC 20460, 
Attention Docket ID No. EPA-HQ-ORD-2009-

[[Page 45438]]

0605. Deliveries are only accepted from 8:30 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays. Special arrangements should 
be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2009-0605. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the closing date will 
be marked ``late'' and may only be considered if time permits. EPA's 
policy is that all comments received will be included in the public 
docket without change. These 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 by statute 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's 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 EPA 
Docket Center (EPA/DC), Room 3334, EPA West Building, 1301 Constitution 
Avenue, NW., Washington, DC 20460. The 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 ORD Docket is (202) 566-
1752.

FOR FURTHER INFORMATION CONTACT: Seema Schappelle, Risk Assessment 
Forum, Mail Code 8105R, Environmental Protection Agency, 1200 
Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202) 
564-3372; fax number: (202) 564-2070, E-mail: [email protected].

SUPPLEMENTARY INFORMATION: Dioxin and dioxin like compounds (DLCs), 
including polychlorinated dibenzo-dioxins (PCDDs), polychlorinated 
dibenzofurans (PCDFs), and polychlorinated biphenyls (PCBs), are 
structurally and toxicologically related halogenated dicyclic aromatic 
hydrocarbons. Dioxins and DLCs are released into the environment from 
several industrial sources, including chemical manufacturing, 
combustion, and metal processing. There is global contamination of air, 
soil and water with trace levels of these compounds that typically 
occur in the environment as chemical mixtures. Dioxins and DLCs do not 
readily degrade; therefore, levels persist in the environment, build up 
in the food chain and accumulate in the tissues of animals. Human 
exposures to these compounds occur primarily through eating 
contaminated foods. The health effects from exposures to dioxins and 
DLCs have been documented extensively in toxicological and 
epidemiological studies.
    Risk assessments have relied on the dioxin toxicity equivalence 
factors (TEFs) approach. Various stakeholders, inside and outside the 
Agency, have called for a more comprehensive characterization of risks; 
therefore, EPA's Risk Assessment Forum (RAF), located in the Office of 
the Science Advisor, identified a need to examine the recommended 
approach for application of the toxicity equivalence methodology in 
human health risk assessments. An RAF Technical Panel developed the 
draft guidance document, ``Recommended Toxicity Equivalency Factors 
(TEFs) for Human Health Risk Assessments of Dioxin and Dioxin-Like 
Compounds,'' to assist EPA scientists in using this methodology to 
assess health risks from dioxins and dioxin-like compounds, as well as 
inform EPA decision makers, other agencies, and the public about this 
methodology. EPA is currently addressing several issues related to 
dioxins and dioxin-like chemicals in the environment. More information 
on these activities is located at: http://cfpub.epa.gov/ncea/CFM/nceaQFind.cfm?keyword=Dioxin.

    Dated: August 26, 2009.
Kevin Teichman,
Acting EPA Science Advisor.
[FR Doc. E9-21194 Filed 9-1-09; 8:45 am]
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