[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

[[Page 26030]]

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]
BILLING CODE 6560-50-P