Document ID: EPA-HQ-ORD-2011-0390-0001
Agency: epa
Document Type: Notice
Title: Draft Toxicological Reviews: 1,4-Dioxane; Public Comment Period and Listening Session
Posted Date: 2011-08-31T04:00Z

[Federal Register Volume 76, Number 169 (Wednesday, August 31, 2011)]
[Notices]
[Pages 54225-54227]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22290]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9457-8; Docket ID No. EPA-HQ-ORD-2011-0390]

Draft Toxicological Review of 1,4-Dioxane: 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.

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SUMMARY: EPA is announcing a 60-day public comment period and a public 
listening session for the external review draft human health assessment 
titled, ``Toxicological Review of 1,4-Dioxane: In Support of Summary 
Information on the Integrated Risk Information System (IRIS)'' (EPA/
635/R-11/003). New studies regarding the toxicity of 1,4-dioxane 
through the inhalation route of exposure are available that were not 
included in the 1,4-dioxane assessment that was posted on the IRIS 
database in 2010 (U.S. EPA, 2010). These studies have been incorporated 
into the previously posted assessment for review (U.S. EPA, 2010). 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. After public review and comment, an EPA 
contractor will convene an expert panel 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 will be scheduled at a later date 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.
    The listening session will be held on October 18, 2011, 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 draft IRIS health assessments 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 independent 
external peer review. If listening session participants would like EPA 
to share their comments with the external peer reviewers, they should 
also submit written comments during the public comment period using the 
detailed and established procedures described in the SUPPLEMENTARY 
INFORMATION section of this notice.

DATES: The public comment period begins August 31, 2011, and ends 
October 31, 2011. Comments should be in writing and must be received by 
EPA by October 31, 2011.
    The listening session on the draft assessment for 1,4-dioxane will 
be held on October 18, 2011, beginning at 9 a.m. and ending at 4 p.m., 
Eastern Daylight Time or when the last presentation has been completed. 
To attend the listening session, interested parties should register no 
later than October 11, 2011. To present at the listening session, 
indicate in your registration that you would like to make oral comments 
at the session and provide the length of your presentation. To attend 
the listening session, register by October 11, 2011 via e-mail at 
bcolon@versar.com (subject line: 1,4-Dioxane Listening Session), by 
phone: 703-750-3000, ext. 6727, or toll free at 1-800-2-VERSAR (ask for 
Betzy Colon, the 1,4-Dioxane Listening Session Coordinator), or by 
faxing a registration request to 703-642-6809 (please reference the 
``1,4-Dioxane Listening Session'' and include your name, title, 
affiliation, full address and contact information). When you register, 
please 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 October 11, 2011, the listening session will be 
cancelled, and EPA will notify those registered of the cancellation.

ADDRESSES: The draft ``Toxicological Review of 1,4-Dioxane: 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 listening session on the draft 1,4-dioxane assessment will be 
held at the EPA offices at Potomac Yard (North Building), Rm. 7100, 
2733 South Crystal Drive, Arlington, Virginia 22202. Please note that 
to gain entrance to this EPA building to attend the meeting, 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

[[Page 54226]]

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 at the beginning of the 
call.
    Information on Services for Individuals with Disabilities: EPA 
welcomes public attendance at the 1,4-dioxane 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 public 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 Patricia 
Gillespie, National Center for Environmental Assessment [Mail Code: B-
243-01], U.S. Environmental Protection Agency, National Center for 
Environmental Assessment, Office of Research and Development
    U.S. Environmental Protection Agency, Research Triangle Park, NC 
27711; telephone: 919-541-1964; facsimile: 919-541-2985; or e-mail: 
FRN_Questions@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-2011-
0390, 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-
2011-0390. 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://

[[Page 54227]]

www.regulations.gov or in hard copy at the OEI Docket in the EPA 
Headquarters Docket Center.

    Dated: July 27, 2011.
David A. Bussard,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2011-22290 Filed 8-30-11; 8:45 am]
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