[Federal Register Volume 78, Number 86 (Friday, May 3, 2013)]
[Notices]
[Pages 26029-26031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10434]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-9808-6; Docket ID No. EPA-HQ-ORD-2009-0398]
Toxicological Review of Methanol (Non-Cancer): In Support of
Summary Information on the Integrated Risk Information System (IRIS)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of a public comment period and peer review on the draft
non-cancer toxicological review of methanol.
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SUMMARY: EPA is announcing a 45-day public comment period and peer
review on the draft toxicological review titled ``Toxicological Review
of Methanol (Non-Cancer): In Support of Summary Information on the
Integrated Risk Information System (IRIS)'' (EPA/635/R-11/001Ba). The
public comment period begins on or about May 3, 2013, and ends June 17,
2013. EPA will announce the date, time, and procedures for public
participation in the peer review in a separate Federal Register Notice,
or in an announcement on the IRIS Web site. EPA is releasing this draft
assessment for the purpose of public comment and peer review. This
draft assessment is not final, as described in EPA's information
quality guidelines, and it does not represent and should not be
construed to represent Agency policy or views.
DATES: The public comment period on the draft Toxicological Review of
Methanol (Non-Cancer) begins on or about May 3, 2013, and ends June 17,
2013. The draft review is posted to the IRIS Web site at http://www.epa.gov/IRIS. Comments should be in writing and received by EPA by
June 17, 2013. Comments received by June 17, 2013, will be provided to
the peer reviewers for their consideration.
ADDRESSES: The draft toxicological review titled ``Toxicological Review
of Methanol (Non-Cancer): In Support of Summary Information on the
Integrated Risk Information System (IRIS)'' is available primarily via
the Internet on the IRIS Web site at http://www.epa.gov/IRIS. 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, please provide your name, mailing address, and the draft
assessment title. Comments may be submitted electronically via http://www.regulations.gov, by email, by mail, by facsimile, or by hand
delivery/courier. Please follow the detailed instructions provided in
the SUPPLEMENTARY INFORMATION section of this notice.
Additional Information: For information on the draft assessment,
please contact Jeffrey Gift, Ph.D., U.S. Environmental Protection
Agency, National Center for Environmental Assessment, Mail Code B243-
01, 109 T.W. Alexander Drive, Durham, NC 27711; telephone: 919-541-
4828; facsimile: 919-541-0245; or email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The draft toxicological review was prepared by the National Center
for Environmental Assessment (NCEA) within the EPA Office of Research
and Development (ORD). The public has been provided an opportunity to
comment on previous external review drafts of the IRIS toxicological
review of methanol. In January 12, 2010, EPA released an external
review draft (EPA/635/R-09/013), containing both cancer
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and non-cancer analyses, for public comment. EPA later placed this
external review on hold pending resolution of issues concerning a
specific set of data used in the cancer analysis. On April 18, 2011,
EPA released for public comment another external review draft (EPA/635/
R-11/001) which contained only a non-cancer analysis. The data and
studies used in the non-cancer analysis are unrelated to the issues
concerning the cancer analysis. On June 22, 2011, EPA released an
addendum to the April 18, 2011, non-cancer external review draft to
provide the public an opportunity to comment on the incorporation of
several new studies into the analysis. On July 22, 2011, Eastern
Research Group (ERG), an EPA contractor for external scientific peer
review, convened an independent panel of experts to conduct a public
peer review meeting on the non-cancer external review draft of the
toxicological review of methanol released on April 18, 2011, (EPA/635/
R-11/001) and the addendum released on June 22, 2011.
The current draft toxicological review titled ``Toxicological
Review of Methanol (Non-Cancer): In Support of Summary Information on
the Integrated Risk Information System (IRIS)'' (EPA/635/R-11/001Ba),
which will be posted on NCEA's Web site, has been revised in response
to the peer review and public comments received on the external review
draft released on April 18, 2011, and the June 22, 2011, addendum. This
notice announces a new public comment period on the current revised
draft toxicological review in advance of an upcoming peer review and in
accordance with applicable information quality guidelines. The external
peer review comments and EPA responses on the previous draft assessment
are summarized in Appendix A of the draft. EPA is releasing this draft
assessment for the purpose of public comment and peer review. This
draft assessment is not final, as described in EPA's information
quality guidelines, and it does not represent and should not be
construed to represent Agency policy or views.
In addition to a second opportunity for public comment announced in
this notice, EPA will also schedule a follow-up external letter peer
review of the draft toxicological review of methanol and will announce
the details of the peer review in an additional Federal Register notice
or on the IRIS Web site. To the extent possible, the Agency intends the
follow-up peer review to be conducted by the same experts that served
on the July 22, 2011, peer review panel. The public comments received
during the comment period announced in this notice will be provided to
the experts that will conduct the follow-up letter peer review. The
peer reviewers will be asked whether EPA adequately responded to the
comments from the July 22, 2011, peer review panel. The letter peer
review will include a public teleconference with a limited opportunity
for the public to address the peer reviewers. EPA will announce the
date, time and procedures for public participation in the
teleconference in a separate Federal Register Notice or in an
announcement on the IRIS Web site.
II. Information About IRIS
EPA's IRIS is a human health assessment program that evaluates
quantitative and qualitative risk information on effects that may
result from exposure to chemical substances found in the environment.
Through the IRIS Program, EPA provides the highest quality science-
based human health assessments to support the Agency's regulatory
activities. The IRIS database contains information for more than 540
chemical substances that can be used to support the first two steps
(hazard identification and dose-response evaluation) of the risk
assessment process. When supported by available data, IRIS provides
oral reference doses (RfDs) and inhalation reference concentrations
(RfCs) for chronic noncancer health effects and cancer assessments.
Combined with specific exposure information, government and private
entities use IRIS to help characterize public health risks of chemical
substances and thereby support risk management decisions designed to
protect public health.
III. How To Submit Comments to the Docket at http://www.regulations.gov
Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2009-
0398, by one of the following methods:
http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
Email: [email protected].
Facsimile: 202-566-9744.
Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 28221T), 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-
2009-0398. 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 email. The
http://www.regulations.gov Web site is an ``anonymous access'' system,
which means that EPA will not know your identity or contact information
unless you provide it in the body of your comments. If you send email
comments directly to EPA without going through http://www.regulations.gov, your email 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
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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
at http://www.regulations.gov or in hard copy at the OEI Docket in the
EPA Headquarters Docket Center.
Dated: April 26, 2013.
Cheryl G. Itkin,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2013-10434 Filed 5-2-13; 8:45 am]
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