Document ID: EPA-HQ-ORD-2010-0123-0001
Agency: epa
Document Type: Notice
Title: Draft Toxicological Review of Inorganic Arsenic: In Support of the Summary Information on the Integrated Risk Information System
Posted Date: 2010-02-19T05:00Z

[Federal Register: February 19, 2010 (Volume 75, Number 33)]
[Notices]               
[Page 7477-7479]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19fe10-71]                         

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9113-7; Docket ID No. EPA-HQ-ORD-2010-0123]

 
Draft Toxicological Review of Inorganic Arsenic: In Support of 
the Summary Information on the Integrated Risk Information System 
(IRIS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: EPA is announcing a 60-day public comment period for the 2010 
draft document titled, ``Toxicological Review of Inorganic Arsenic: In 
Support of the Summary Information on the Integrated Risk Information 
System (IRIS)'' (EPA/635/R-10/001). The draft document was prepared by 
the National Center for Environmental Assessment (NCEA) within the 
EPA's Office of Research and Development (ORD). The Toxicological 
Review of Inorganic Arsenic was submitted to the EPA's Science Advisory 
Board (SAB) for external peer review in 2005. The SAB completed its 
review and submitted its final report to the EPA Administrator in June 
2007 (see EPA-SAB-07-008 at www.epa.gov/sab). EPA revised the 
Toxicological Review in response to the SAB comments. A detailed 
account of the SAB (2007) recommendations and EPA's response is 
provided in Appendix A of the 2010 draft Toxicological Review of 
Inorganic Arsenic.
    EPA has now submitted the 2010 draft Toxicological Review to the 
SAB for a focused peer review of EPA's responses to key SAB (2007) 
recommendations. EPA is also seeking a focused review by the public on 
EPA's interpretation and implementation of key SAB (2007) external peer 
review recommendations. The public comment period and SAB review are 
separate processes that provide opportunities for all interested 
parties to comment on the document. SAB's peer review meeting will be 
announced in a separate Federal Register notice. EPA intends to forward 
the public comments that are submitted in accordance with this notice 
to the SAB peer review panel prior to the meeting for their 
consideration. However, because of the timing of the SAB's peer review 
meeting, EPA can

[[Page 7478]]

only guarantee that those comments submitted by March 26, 2010, in 
response to this Federal Register notice will be provided to the SAB 
panel prior to the SAB meeting. Comments received after March 26 will 
still be provided to the SAB panel and will inform the Agency's 
revision of the draft assessment, but EPA cannot guarantee that the 
panel will have them prior to the peer review meeting. In addition, EPA 
cannot grant any requests for an extension of the comment period 
because of the scheduled SAB peer review meeting. When finalizing the 
Toxicological Review of Inorganic Arsenic, EPA intends to consider any 
public comments that EPA receives in accordance with this notice.
    EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality 
guidelines. This document has not been formally disseminated by EPA. It 
does not represent and should not be construed to represent any Agency 
policy or determination.

DATES: The public comment period begins February 19, 2010, and ends 
April 20, 2010. Comments should be in writing and must be received by 
EPA by April 20, 2010.
    EPA can only guarantee that those comments submitted by March 26, 
2010, in response to this Federal Register notice will be provided to 
the SAB panel prior to the SAB meeting. Comments received after March 
26 will still be provided to the SAB panel and will inform the Agency's 
revision of the draft assessment, but EPA cannot guarantee that the 
panel will have them prior to the peer review meeting.

ADDRESSES: The draft ``Toxicological Review of Inorganic Arsenic: In 
Support of the 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 are requesting a paper copy, please provide your name, 
mailing address, and the document 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.

FOR FURTHER INFORMATION CONTACT: For information on submitting comments 
to the docket, 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.
    If you have questions about the document, please contact Reeder 
Sams, National Center for Environmental Assessment (NCEA), U.S. EPA, 
109 T.W. Alexander Drive, B243-01, Durham, NC 27711; telephone: 919-
541-0661; facsimile: 919-541-0245; or e-mail: sams.reeder@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Information About IRIS

    IRIS is a human health assessment program that evaluates 
quantitative and qualitative risk information on effects that may 
result from exposure to specific 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 oral slope factors and 
inhalation unit risks for carcinogenic effects. 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-2010-
0123, 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's 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.
    EPA recommends that you include your name and other contact 
information in the body of your comment and with any disk or CD-ROM you 
submit. If EPA cannot read your comment and cannot contact you for 
clarification, EPA may not be able to consider your comment.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2010-0123. 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 a comment includes 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 EPA will not know your identity or contact 
information unless you provide it in the body of your comment. If you 
send an e-mail comment directly to EPA without going through http://

[[Page 7479]]

www.regulations.gov, your e-mail address will be automatically captured 
and included as part of the comment that is placed in the public docket 
and made available on the Internet. If you submit an electronic 
comment, EPA recommends that you include your name and other contact 
information in the body of your comment and with any disk or CD-ROM you 
submit. If EPA cannot read your comment due to technical difficulties 
and cannot contact you for clarification, EPA may not be able to 
consider your comment. 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 
in http://www.regulations.gov or in hard copy at the OEI Docket in the 
EPA Headquarters Docket Center.

    Dated: February 12, 2010.
Rebecca Clark,
Director, National Center for Environmental Assessment.
[FR Doc. 2010-3240 Filed 2-18-10; 8:45 am]
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