Draft Toxicological Review of Nitrobenzene (CASRN 98-95-3): In Support of the Summary Information in the Integrated Risk Information System (IRIS)

Summary:

EPA is announcing that the Oak Ridge Institute of Science and Education (ORISE), under an agreement between the Department of Energy and EPA, will convene an independent panel of experts and organize and conduct an external peer-review workshop to review the external review draft document titled, “Toxicological Review of Nitrobenzene: In Support of Summary Information in the Integrated Risk Information System (IRIS).” The EPA also is announcing a public comment period for the external review draft document.

The public comment period and the external peer-review workshop are separate processes that provide opportunities for all interested parties to comment on the document. In addition to consideration by EPA, all public comments submitted in accordance with this notice will also be forwarded to ORISE for consideration by the external peer-review panel prior to the workshop.

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. ORISE invites the public to register to attend this workshop as observers. In addition, ORISE invites the public to give brief oral comments at the workshop regarding the draft document under review. The draft document and EPA's peer-review charge are available via the Internet on the National Center for Environmental Assessment's (NCEA's) home page under the Recent Additions and the Publications menus at http://www.epa.gov/ncea. When finalizing the draft document, EPA will consider ORISE's report of the comments and recommendations from the external peer-review workshop and any publiccomments that EPA receives in accordance with this notice.

Table of Contents

Dates:

The external peer-review panel workshop will begin on May 15, 2007, at 9:00 a.m. and end at 4:00 p.m. The public comment period begins March 29, 2007 and ends April 30, 2007. Technical comments should be in writing and must be received by EPA by April 30, 2007. Comments received from the public by this date will be submitted to the external peer-review panel prior to the workshop.

Addresses:

The external peer-review workshop will be held at the American Geophysical Union, 2000 Florida Avenue, Washington, DC. ORISE is organizing, convening, and conducting the peer-review workshop. To attend the workshop and/or provide brief oral comments, you must register by May 1, 2007, via the Internet at http://www.orau.gov/nitrobenzene. You may also register by calling ORISE at 865-576-2922, sending a facsimile to 865-241-3168, or sending an e-mail to Margaret Lyday at Margaret.Lyday@orise.orau.gov.

The draft document, “Toxicological Review of Nitrobenzene: In Support of Summary Information in the Integrated Risk Information System (IRIS)” is available via the Internet on NCEA's home page under the Recent Additions and the Publications menus at http://www.epa.gov/ncea. A limited number of paper copies are available from NCEA's Technical Information Staff (telephone; 202-564-3261, facsimile 202-565-0050). If you are requesting a paper copy, please provide your name, mailing address, and the document title. Copies are not available from ORISE.

Comments may be submitted electronically at http:// www.regulations.gov, by mail, by facsimile, or by hand delivery/courier. Please follow the detailed instructions as provided in the SUPPLEMENTARY INFORMATION section of this notice.

For further information contact:

For information on the peer-review workshop, contact Margaret Lyday by mail: Oak Ridge Institute for Science and Education, P.O. Box 117, Oak Ridge, TN 37831-0117; phone: 865-576-2922; facsimile: 865-241-3168; or e-mail:Margaret.Lyday@orise.orau.gov.

For information on the public comment period, contact the Office of Environmental Information Docket by phone: 202-566-1752; facsimile: 202-566-1753; or e-mail:ORD.Docket@epa.gov.

If you have questions about the document, contact Dr. Stedeford, IRIS Staff, National Center for Environmental Assessment, by mail: U.S. EPA (8601D), 1200 Pennsylvania Avenue, NW., Washington, DC 20460; phone: 202-564-2066; facsimile: 202-565-0075; or e-mail:Stedeford.Todd@epa.gov.

Supplementary information:

I. Summary of Information About the Integrated Risk Information System (IRIS)

IRIS is a database that contains information regarding potential adverse human health effects that may result from chronic (or lifetime) exposure to specific chemical substances found in the environment. The database (available on the Internet at http://www.epa.gov/iris) contains qualitative and quantitative health effects information for more than 540 chemical substances that may be used to support the first two steps (hazard identification and dose-response evaluation) of a risk assessment process. When supported by available data, the database provides oral reference doses (RfDs) and inhalation reference concentrations (RfCs) for chronic health effects, and oral slope factors and inhalation unit risks for carcinogenic effects. Combined with specific exposure information, government and private entities can 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. Workshop Information

Members of the public may attend the workshop as observers, and there will be a limited time for comments from the public. If you wish to make oral comments during the review, you must pre-register at http://www.orau.gov/nitrobenze by May 1, 2007. Space is limited and reservations will be accepted on a first-come, first-served basis.

III. How To Submit Technical Comments to the Docket at http://www.regulations.gov

Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2007-0241 by one of the following methods:

http://www.regulations.gov: Follow the on-line instructions for submitting comments.

E-mail: ORD.Docket@epa.gov.

Fax:202-566-1753.

Mail: Office of Environmental Information (OEI) Docket (Mail Code: 2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. The phone number is 202-566-1752.

Hand Delivery: The OEI Docket is located in the EPA Headquarters Docket Center, EPA West Building, Room 3334, 1301 Constitution Avenue, 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. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. Consult EPA's Web site at http://www.epa.gov/epahome/dockets.htm for current information on docket operations, locations, and telephone numbers.

If you provide comments by mail or 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-2007-0241. 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://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, any form of encryption, and be free of any defects orviruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

Docket: 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 materials, such as copyrighted material, are 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: March 26, 2007. David Bussard,

Acting Director, National Center for Environmental Assessment.

References

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