[Federal Register: September 2, 2009 (Volume 74, Number 169)]
[Notices]
[Page 45437-45438]
[DOCID:fr02se09-52]

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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Assessments of Dioxin and Dioxin-Like Compounds,'' a draft guidance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 This draft guidance document does not represent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_ADDRESS>     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-

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:<PHONE_NUMBER>, E-mail<EMAIL_ADDRESS>
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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