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An Approach To Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate (DBP) Case Study

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AGENCY:

Environmental Protection Agency (EPA).

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ACTION:

Notice of peer-review workshop and public comment period.

SUMMARY:

EPA is announcing that Eastern Research Group, Inc., an EPA contractor for external scientific peer review, will convene an independent panel of experts and organize and conduct an external peer-review workshop to review the external review draft document titled, “An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate Case Study” (EPA/600/R-09/028A). The EPA also is announcing a 30-day public comment period for the draft document. The draft document was prepared by the National Center for Environmental Assessment (NCEA) within EPA's Office of Research and Development. EPA is interested in developing methods to use genomic data most effectively in risk assessments performed at the Agency. NCEA developed this draft report for the purpose of describing an approach to using toxicogenomic data in risk assessment and illustrating the approach with a case study.

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. EPA intends to forward public comments that are submitted in accordance with this notice to the external peer-review panel prior to the meeting for their consideration. When finalizing the draft document, 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.

Eastern Research Group, Inc. invites the public to register to attend this workshop as observers. In addition, Eastern Research Group, Inc. invites the public to give oral and/or provide written comments at the workshop regarding the draft document under review. The draft document and EPA's peer-review charge are available primarily via the Internet on NCEA's home page under the Recent Additions and the Data and Publications menus at http://www.epa.gov/​ncea. In preparing a final report, EPA will consider any comments and recommendations from the external peer-review workshop and any public comments that EPA receives in accordance with this notice.

DATES:

The peer-review panel workshop will begin on Tuesday, June 23, 2009, at 8:30 a.m. and end at 4:30 p.m. Observers must register by Monday, June 15, 2009, and indicate if they wish to make brief oral statements at the workshop. The 30-day public comment period begins May 20, 2009, and ends June 19, 2009. Technical comments should be in writing and must be received by EPA by June 19, 2009.

ADDRESSES:

The peer-review workshop will be held at Holiday Inn Capitol, 550 C Street, SW., Washington, DC 20024. The EPA contractor, Eastern Research Group, Inc., is organizing, convening, and conducting the peer-review workshop. To attend the workshop as an observer, register by Monday, June 15, 2009, via the Internet at https://www2.ergweb.com/​projects/​conferences/​peerreview/​register-TgX.htm. You may also register by e-mail at meetings@erg.com (subject line: TgX in Risk Assessment Peer Review Workshop), by phone: 781-674-7374 or toll free at 800-803-2833, or by faxing a registration request to 781-674-2906 (please reference the “TgX in Risk Assessment Peer Review Workshop” and include your name, title, affiliation, full address and contact information).

The draft “An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate Case Study” is available primarily via the Internet on NCEA's Internet home page under the Recent Additions and the Data and Publications menus at http://www.epa.gov/​ncea. A limited number of paper copies are available from the Information Management Team, NCEA; 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, “An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate Case Study”. Copies are not available from Eastern Research Group, Inc. Comments may be submitted electronically via 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.

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FOR FURTHER INFORMATION CONTACT:

Questions regarding information, registration, access or services for individuals with disabilities, or logistics for the external peer-review workshop should be directed to Laurie Waite, Eastern Research Group, Inc., 110 Hartwell Ave., Lexington, MA 02421; telephone: 781-674-7362; facsimile 781-674-2906; e-mail laurie.waite@erg.com. To request accommodation of a disability, please contact Laurie Waite, preferably at least 10 days prior to the workshop, to give as much time as possible to process your request.

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

If you need technical information about the document, please contact Susan Y. Euling, National Center for Environmental Assessment (NCEA); telephone: 703-347-8575; facsimile: 703-347-8692; e-mail euling.susan@epa.gov.

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SUPPLEMENTARY INFORMATION:

I. Summary of Information About the Project/Document

The National Center for Environmental Assessment (NCEA) prepared this draft document for the purpose of describing an approach to using toxicogenomic data in risk assessment and illustrating the approach with a case study. The approach and case study described in this draft report were developed by a team of scientists at EPA laboratories and centers, and outside organizations including The Hamner Institute, the National Institute for Environmental Health Sciences, and the EPA's Science to Achieve Results (STAR) Bioinformatics Center at the University of Medicine and Dentistry of New Jersey and Rutgers University. The approach outlined is expected to be useful to risk assessors in EPA, as well as other federal agencies, and the scientific community at large. A case study to test the approach for dibutyl phthalate (DBP) is described. The case study presented in this draft document is a separate activity from any of the ongoing IRIS human health assessments for the phthalates.

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. Pre-registration is strongly recommended as space is limited, and registrations will be accepted on a first-come, first-served basis. The deadline for pre-registration is June 15, 2009. If space allows, registrations will continue to be accepted after this date, including on-site registrations. Time will be set aside to hear comments from observers, and individuals will be limited to a maximum of five minutes during the morning session of peer review Start Printed Page 23715workshop. Please let ERG know if you wish to make comments during the workshop by registering on the Web site at https://www2.ergweb.com/​projects/​conferences/​peerreview/​register-TgX.htm and indicating your intent to make oral comments.

III. How to Submit Technical Comments to the Docket at www.regulations.gov.

Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2009-0243, by one of the following methods:

  • 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 Ave., NW., Washington, DC 20460. The phone number is 202-566-1752.
  • Hand Delivery: The OEI Docket is located in the EPA Headquarters Docket Center, Room 3334 EPA West Building, 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. Such 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 mail or hand delivery, please submit 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-2009-0243. 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 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 regulations.gov or e-mail. The 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 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 or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at www.epa.gov/​epahome/​dockets.htm.

Docket: Documents in the docket are listed in the 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 regulations.gov or in hard copy at the OEI Docket in the EPA Headquarters Docket Center.

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Dated: May 13, 2009.

Rebecca Clark,

Acting Director, National Center for Environmental Assessment.

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[FR Doc. E9-11744 Filed 5-19-09; 8:45 am]

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