Document ID: EPA-HQ-ORD-2009-0398-0023
Agency: epa
Document Type: Notice
Title: Draft Toxicological Review of Methanol (Non-Cancer): In Support of Summary Information on the Integrated Risk Information System
Posted Date: 2011-04-18T04:00Z

[Federal Register Volume 76, Number 74 (Monday, April 18, 2011)]
[Notices]
[Pages 21736-21738]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9293]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9297-2; Docket ID No. EPA-HQ-ORD-2009-0398]

Draft 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 and listening session.

-----------------------------------------------------------------------

SUMMARY: EPA is announcing a 60-day public comment period and listening 
session for the external 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). The draft assessment was prepared by the National Center 
for Environmental Assessment (NCEA) within the EPA Office of Research 
and Development (ORD). EPA is releasing this draft assessment solely 
for the purpose of pre-dissemination peer review 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.
    In January 2010, EPA released an external peer review draft IRIS 
Toxicological Review for methanol (EPA/635/R-09/013), containing both 
cancer and non-cancer analyses, and requested that the Science Advisory 
Board conduct a review of this human health assessment. Following a 
report from the National Toxicology Program, EPA placed the external 
peer review of the draft IRIS Methanol Toxicological Review on hold. 
The National Toxicology Program report recommended that pathology 
reviews be carried out to resolve differences of opinion in the 
diagnoses of certain tumors reported in a Ramazzini Institute methanol 
research study, which was cited and used to support some of the 
conclusions in the draft IRIS assessment. As a result, EPA and the 
National Institute of Environmental Health Sciences plan to jointly 
sponsor an independent Pathology Working Group (PWG) review of select 
studies conducted at the Institute. EPA is today releasing the draft 
IRIS Methanol Toxicological Review (Non-Cancer) for public comment 
while continuing to hold the cancer assessment that was previously 
released in January 2010. The data and studies used in the draft IRIS 
Methanol Toxicological Review (Non-Cancer) are unrelated to the tumor 
diagnoses being re-examined by the PWG. The information, analyses and 
conclusions of the draft assessment announced in this notice are 
identical to the non-cancer portions of the draft assessment previously 
released in January 2010. Comments relevant to the non-cancer methanol 
assessment that were received during the previous public comment period 
for the joint cancer and non-cancer assessment will be considered along 
with new comments.
    An EPA listening session will be held on May 26, during the public 
comment period for this draft assessment. The purpose of the listening 
session is to allow all interested parties to present scientific and 
technical comments on the draft IRIS health assessment to EPA and other 
interested parties attending the listening session. EPA welcomes the 
comments that will be provided to the Agency by the listening session 
participants. The comments will be considered by the Agency as it 
revises the draft assessment after the external peer review. EPA will 
compile a list of meeting participants, including the name, principal 
affiliation, and sponsor of each person attending or calling in to the 
meeting. The list of listening session participants as well as 
presentations and written materials given to NCEA will be made a part 
of the public record.
    After public review and comment, an EPA contractor will hold a 
meeting of expert panelists for independent external peer review of 
this draft assessment. The public comment period and external peer 
review meeting are separate processes that provide opportunities for 
all interested parties to comment on the assessment. The external peer 
review meeting, to be scheduled at a later date, will be open to the 
public and announced in the Federal Register. Public comments submitted 
during the public comment period will be provided to the external peer 
reviewers before the panel meeting and considered by EPA in the 
disposition of public comments. Public comments received after the 
public comment period closes will not be submitted to the external peer 
reviewers and will only be considered by EPA if time permits.

DATES: The public comment period begins April 18, 2011, and ends June 
17, 2011. Comments should be in writing and must be received by EPA by 
June 17, 2011.
    The listening session on the draft assessment for methanol will be 
held on May 26, beginning at 9 a.m. and ending at 4 p.m., Eastern Time. 
Interested parties who wish to attend the listening session should 
register no later than May 19. If you wish to present at the listening 
session, indicate in your registration that you would like to make oral 
comments and provide the length of your presentation. To register to 
speak and/or listen send an e-mail to IRISListeningSession@epa.gov 
(subject line: Methanol Listening Session); call Christine Ross at 703-
347-8592; or fax a registration request to 703-347-8689. Please 
reference the ``Methanol Listening Session'' and include your name, 
title, affiliation, sponsor information, full address and contact 
information. Indicate if you will need audio-visual equipment (e.g., 
laptop computer and slide projector). In general, each presentation 
should be no more than 30 minutes. If, however, there are more requests 
for presentations than the allotted time allows, then the time limit 
for each presentation will be adjusted. A copy of the agenda for the 
listening session will be available at the meeting. If no speakers have 
registered by May 19, the listening session will be cancelled, and EPA 
will notify those registered of the cancellation.

ADDRESSES: The draft ``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

[[Page 21737]]

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 listening session on the draft assessment for methanol will be 
held at the EPA offices at Potomac Yard North Building, N-7100, 2733 
South Crystal Drive, Arlington, Virginia 22202. Please note that to 
gain entrance to this EPA building to attend the Methanol Listening 
Session, you must have photo identification and must register at the 
guard's desk in the lobby. The guard will retain your photo 
identification and will provide you with a visitor's badge. At the 
guard's desk, you should provide the name Christine Ross and the 
telephone number 703-347-8592 to the guard on duty. The guard will 
contact Ms. Ross who will meet you in the reception area to escort you 
to the meeting room. When you leave the building, please return your 
visitor's badge to the guard and you will receive your photo 
identification.
    A teleconference line will also be available for registered 
attendees/speakers. The teleconference number is 866-299-3188, and the 
access code is 926-378-7897, followed by the pound sign (). 
The teleconference line will be activated at 8:45 a.m., and you will be 
asked to identify yourself and your affiliation and sponsors at the 
beginning of the call.
    Information on Services for Individuals with Disabilities: EPA 
welcomes public attendance at the Methanol Listening Session and will 
make every effort to accommodate persons with disabilities. For 
information on access or services for individuals with disabilities, 
please contact Christine Ross by phone at 703-347-8592 or by e-mail at 
IRISListeningSession@epa.gov. To request accommodation for a 
disability, please contact Ms. Ross, preferably at least 10 days prior 
to the meeting, to give EPA as much time as possible to process your 
request.
    Additional Information: For information on the docket, http://www.regulations.gov, or the 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: ORD.Docket@epa.gov.
    For information on the Methanol Listening Session, please contact 
Christine Ross, IRIS Staff, National Center for Environmental 
Assessment (Mail Code: 8601P), U.S. Environmental Protection Agency, 
1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone: 703-
347-8592; facsimile: 703-347-8689; or e-mail: 
IRISListeningSession@epa.gov.
    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

[[Page 21738]]

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: March 28, 2011.
Darrell A. Winner,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2011-9293 Filed 4-15-11; 8:45 am]
BILLING CODE 6560-50-P