[Federal Register Volume 75, Number 98 (Friday, May 21, 2010)]
[Notices]
[Pages 28610-28612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-12280]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-9154-2; Docket ID No. EPA-HQ-ORD-2010-0395]
Draft EPA's Reanalysis of Key Issues Related to Dioxin Toxicity
and Response to NAS Comments
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of Public Comment Period.
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SUMMARY: EPA is announcing a 90-day public comment period for the
external review draft entitled, ``EPA's Reanalysis of Key Issues
Related to Dioxin Toxicity and Response to NAS Comments'' (EPA/600/R-
10/038A). This draft report responds to the key recommendations and
comments included in the National Academy of Sciences (NAS) 2006
report. In addition, it includes new analyses on potential human
effects that may result from exposure to 2,3,7,8-tetrachlorodibenzo-p-
dioxin (TCDD). These analyses have not been in previous versions of
draft reports related to EPA's dioxin reassessment activity. This draft
report is now considered to be under EPA's Integrated Risk Information
System (IRIS) program, and thus, the new IRIS process announced in May
2009 (http://www.epa.gov/iris/process/) is being followed. Per the May
2009 process, this draft report is beginning Step 4--independent
external peer review and public review and comment. This draft dioxin
report was prepared by the National Center for Environmental Assessment
(NCEA) within the EPA Office of Research and Development (ORD).
The draft document, ``EPA's Reanalysis of Key Issues Related to
Dioxin Toxicity and Response to NAS Comments,'' is also being provided
to EPA's Science Advisory Board (SAB), a body established under the
Federal Advisory Committee Act, for independent external peer review.
The SAB will convene an expert panel composed of scientists
knowledgeable about technical issues related to dioxins and risk
assessment. The SAB is expected to hold a public teleconference on or
about June 24, 2010, and a public panel meeting on July 13-15, 2010.
The SAB peer review meetings will be announced by the SAB staff office
in a separate Federal Register Notice. EPA intends to forward all
public comments submitted before July 7, 2010, in response to this
notice to the SAB peer review panel for their consideration. Members of
the public who wish to ensure that their technical comments are
provided to the SAB expert panel before each meeting should also e-mail
their comments separately to Thomas Armitage, the SAB Designated
Federal Officer at [email protected], following the procedures in
the Federal Register Notice announcing the SAB public meetings. When
completing this draft dioxin report, EPA will consider any written
public comments that EPA receives in accordance with the detailed
instructions provided below under SUPPLEMENTARY INFORMATION. The public
comment period and SAB external peer review are independent processes
that provide separate opportunities for all interested parties to
comment on the draft report.
EPA is releasing this draft report solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This draft report 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 public comment period begins May 21, 2010, and ends August
19, 2010. Comments should be in writing and must be received by EPA by
August 19, 2010.
Due to the timing of the SAB's peer review meeting, EPA can only
guarantee that those comments received by July 7, 2010, in response to
this Federal Register notice will be provided to the SAB panel prior to
the SAB meeting. Comments received after July 7, will still be provided
to the SAB panel and will also inform the Agency's revision of the
draft report.
ADDRESSES: The external review draft titled, ``EPA's Reanalysis of Key
Issues Related to Dioxin Toxicity and Response to NAS Comments'' (EPA/
600/R-10/038A) is available primarily via the Internet on the NCEA 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 Information Management Team (Address: Information Management Team,
National Center for Environmental Assessment (Mail Code: 8601P), U.S.
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone: 703-347-8561; facsimile: 703-347-
8691). If you request a paper copy,
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please provide your name, mailing address, and the assessment title.
Comments may be submitted electronically via http://www.regulations.gov, by e-mail, 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 docket,
regulations.gov or public comment period, please contact the Office of
Environmental Information (OEI) Docket (Mail Code: 2822T), U.S.
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone: 202-566-1752; facsimile: 202-566-1753;
or e-mail: [email protected].
For information on the draft report, please contact Linda C. Tuxen,
National Center for Environmental Assessment (8601P), U.S.
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone: 703-347-8609; facsimile: 703-347-8699;
or e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Information About the Draft Report, ``EPA's Reanalysis of Key Issues
Related to Dioxin Toxicity and Response to NAS Comments''
In 2003, EPA, along with other federal agencies, asked the NAS to
review aspects of the science in EPA's draft dioxin reassessment
entitled, ``Exposure and Human Health Reassessment of 2,3,7,8-
Tetrachlorodibenzo-p-Dioxin (TCDD) and Related Compounds,'' and, in
2004, EPA sent a 2003 external review draft dioxin reassessment to the
NAS for their peer review. The NAS held several public meetings during
their review of the draft reassessment and on July 11, 2006, released
the final report of their review entitled, ``Health Risks from Dioxin
and Related Compounds: Evaluation of the EPA Reassessment.''
The NAS identified three key areas in the 2003 draft reassessment
that required substantial improvement to support a more scientifically
robust risk characterization. These three areas were: (1) Justification
of approaches to dose-response modeling for cancer and non-cancer
endpoints; (2) transparency and clarity in selection of key data sets
for analysis; and (3) transparency, thoroughness, and clarity in
quantitative uncertainty analysis. The NAS provided EPA with
recommendations to address their key concerns.
EPA's draft dioxin report, which is being provided for public
review and comment, includes significant new analyses on both the
potential cancer and noncancer human health effects that may result
from exposures to TCDD. For instance, this draft report addresses the
explicit recommendation of the NAS to develop a quantitative risk
estimate for noncancer effects that may result from long-term (chronic)
oral exposure to dioxins. Thus, this draft dioxin report includes an
oral reference dose (RfD) for TCDD--the most well-studied and
considered to be among the most toxic of the dioxin-like compounds. An
RfD was not in the 2003 draft dioxin reassessment.
In addition, in 2003, EPA and other federal agencies developed a
set of questions and answers related to dioxins, which have been
updated about every year and a half. These materials have again been
updated to include more recent information. These questions and answers
provide general information on dioxins such as what they are, where
they can be found, and major sources of dioxins. They also discuss
possible effects of dioxin exposure in humans, include advice about
consumption of food that might contain dioxins, and explain the review
process for the dioxin reassessment. For additional information on
dioxins and on EPA's overall dioxin assessment activity, these
questions and answers may be accessed at: http://www.fda.gov/Food/FoodSafety/FoodContaminantsAdulteration/ChemicalContaminants/DioxinsPCBs/ucm077524.htm.
II. How To Submit Comments to the Docket at http://www.regulations.gov
Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2010-
0395, by one of the following methods:
http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: [email protected].
Facsimile: 202-566-1753.
Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The telephone number is
202-566-1752. If you provide comments by mail, 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.
Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 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. 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 by
hand delivery, 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-
2010-0395. 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. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at http://www.regulations.gov, including any personal information provided,
unless comments include 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 comments. If you send e-mail
comments directly to EPA without going through http://www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comments that are placed in the public
docket and made available on the Internet. If you submit electronic
comments, EPA recommends that you include your name and other contact
information in the body of your comments and with any disk or CD-ROM
you submit. If EPA cannot read your comments due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comments. Electronic files should avoid the use
of special characters and 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
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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 at http://www.regulations.gov or in
hard copy at the OEI Docket in the EPA Headquarters Docket Center.
Dated: May 17, 2010.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2010-12280 Filed 5-20-10; 8:45 am]
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