Document ID: EPA-HQ-ORD-2009-0398-0029
Agency: epa
Document Type: Notice
Title: Public Comment Periods on Draft Addendums and Peer Review Workshops: Toxicological Review of Methanol (Non-Cancer) in Support of Summary Information on Integrated Risk Information System
Posted Date: 2011-06-22T04:00Z

[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Notices]
[Pages 36534-36535]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15631]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9322-7; 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 public comment period on draft addendum and peer 
review workshop.

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SUMMARY: On April 18, 2011, EPA released the external peer review draft 
human health assessment titled ``Toxicological Review of Methanol (Non-
Cancer): In Support of Summary Information on the Integrated Risk 
Information System (IRIS)'' (EPA/635/R-11/001) for public comment. The 
public comment period ended June 17, 2011. EPA is releasing an addendum 
to the draft Toxicological Review of Methanol (Non-Cancer) and 
announcing a 14-day public comment period for the addendum.
    The purpose of this addendum is to provide the public with several 
recent studies that were published between the initial release of the 
methanol assessment in January 2010 and the recent re-release of the 
non-cancer portion of that assessment in April 2011. Due to the unusual 
step of placing the methanol assessment on hold (as described in the 
April 18, 2011 Federal Register Notice), and the length of time that 
elapsed since the initial release of the assessment, EPA decided to 
issue the addendum addressing additional studies. Description and 
analyses of these studies are included as an addendum to the draft 
Toxicological Review that is now available on EPA's Web site (see below 
for details).
    The draft Toxicological Review and the draft addendum were prepared 
by the National Center for Environmental Assessment (NCEA) within the 
EPA Office of Research and Development (ORD). EPA is releasing the 
draft addendum solely for the purpose of pre-dissemination peer review 
and public comment under applicable information quality guidelines. 
This draft assessment has not been formally disseminated by EPA. It 
does not represent and should not be construed to represent any Agency 
policy or determination.
    EPA is also announcing that Eastern Research Group, Inc. (ERG), an 
EPA contractor for external scientific peer review, will convene an 
independent panel of experts and organize and conduct an external peer 
review workshop to review the draft Toxicological Review of Methanol 
(Non-Cancer), including the addendum. ERG invites the public to 
register to attend this workshop as observers. In addition, ERG invites 
the public to give brief oral comments and/or provide written comments 
at the workshop regarding the draft assessment under review. Space is 
limited, and reservations will be accepted on a first-come, first-
served basis. In preparing a final report, EPA will consider the ERG 
report of the comments and recommendations from the external peer 
review workshop and any written public comments that EPA receives in 
accordance with the April 18, 2011, Notice and this Notice.

DATES: The public comment period on the draft addendum to the 
Toxicological Review of Methanol (Non-Cancer) begins June 22, 2011, and 
ends July 6, 2011. Comments should be in writing and must be received 
by EPA by July 6, 2011.
    The peer review panel workshop on the Toxicological Review of 
Methanol (Non-Cancer) will be held on July 22, 2011, beginning at 8:30 
a.m. and ending at 5 p.m. Eastern Time.

ADDRESSES: The draft addendum to the ``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 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, please provide your name, mailing 
address, and the draft 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.
    The peer review workshop on the draft Toxicological Review of 
Methanol (Non-Cancer) will be held at Hilton Raleigh-Durham Airport at 
Research Triangle Park, 4810 Creek Lane, Durham, NC 27703. To attend 
the workshop, register no later than July 15, 2011, by calling Eastern 
Research Group, Inc., at 781-674-7374 or toll free at 800-803-2833 (ask 
for the Methanol peer review coordinator, Laurie Waite); sending a 
facsimile to 781-674-2906 (reference the ``Methanol Peer Review 
Workshop'' and include your name, title, affiliation, full address and 
contact information), or sending an e-mail to meetings@erg.com 
(reference the ``Methanol Peer Review Workshop'' and include your name, 
title, affiliation, full address and contact information). You can also 
register via the Internet at https://www2.ergweb.com/projects/conferences/peerreview/register-toxmethanol.htm. Space is limited, and 
reservations will be accepted on a first-come, first-served basis. 
There will be a limited time at the peer review workshop for comments 
from the public. Please inform ERG if you wish to make comments during 
the workshop.
    Information on Services for Individuals with Disabilities: EPA 
welcomes public attendance at the ``Methanol Peer Review Workshop'' and 
will make every effort to accommodate persons with disabilities. For 
information on access or services for individuals with disabilities, 
contact ERG, 110 Hartwell Avenue, Lexington, MA 02421-3136 by calling 
781-674-7374 or toll free at 800-803-2833 (ask for the Methanol peer 
review coordinator, Laurie Waite); sending a facsimile to 781-674-2906 
(reference the ``Methanol Peer Review Workshop'' and include your name 
and contact information), or sending an e-mail to meetings@erg.com 
(reference the ``Methanol Peer Review Workshop'' and

[[Page 36535]]

include your name and contact information).

Additional Information

    For information on the draft assessment, please contact Jeffrey 
Gift, PhD, 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 
e-mail: gift.jeff@epa.gov.

SUPPLEMENTARY INFORMATION:

I. 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 in a site-specific situation and thereby support risk 
management decisions designed to protect public health.

II. 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.
     E-mail: ORD.Docket@epa.gov.
     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-
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 e-mail. 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 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 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: June 10, 2011.
David Bussard,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2011-15631 Filed 6-21-11; 8:45 am]
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