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Notice

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

Document Details

Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of public comment period.

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 Start Printed Page 7478only 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.

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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.

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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://Start Printed Page 7479www.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.

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Dated: February 12, 2010.

Rebecca Clark,

Director, National Center for Environmental Assessment.

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[FR Doc. 2010-3240 Filed 2-18-10; 8:45 am]

BILLING CODE 6560-50-P