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Notice

Toxicological Review of Methanol (Non-Cancer): In Support of Summary Information on the Integrated Risk Information System (IRIS)

Action

Notice Of Public Comment Period On Draft Addendum And Peer Review Workshop.

Summary

On April 18, 2011, EPA released the external peer review draft human health assessment titled “Toxicological Review of Methanol (Non-Cancer): In Support of Summary Information on the Integrated Risk Information System (IRIS)” (EPA/635/R-11/001) for public comment. The public comment period ended June 17, 2011. EPA is releasing an addendum to the draft Toxicological Review of Methanol (Non-Cancer) and announcing a 14-day public comment period for the addendum.

The purpose of this addendum is to provide the public with several recent studies that were published between the initial release of the methanol assessment in January 2010 and the recent re-release of the non-cancer portion of that assessment in April 2011. Due to the unusual step of placing the methanol assessment on hold (as described in the April 18, 2011 Federal Register Notice), and the length of time that elapsed since the initial release of the assessment, EPA decided to issue the addendum addressing additional studies. Description and analyses of these studies are included as an addendum to the draft Toxicological Review that is now available on EPA's Web site (see below for details).

The draft Toxicological Review and the draft addendum were prepared by the National Center for Environmental Assessment (NCEA) within the EPA Office of Research and Development (ORD). EPA is releasing the draft addendum solely for the purpose of pre-dissemination peer review and public comment 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.

EPA is also announcing that Eastern Research Group, Inc. (ERG), 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 draft Toxicological Review of Methanol (Non-Cancer), including the addendum. ERG invites the public to register to attend this workshop as observers. In addition, ERG invites the public to give brief oral comments and/or provide written comments at the workshop regarding the draft assessment under review. Space is limited, and reservations will be accepted on a first-come, first-served basis. In preparing a final report, EPA will consider the ERG report of the comments and recommendations from the external peer review workshop and any written public comments that EPA receives in accordance with the April 18, 2011, Notice and this Notice.

 

Table of Contents Back to Top

DATES: Back to Top

The public comment period on the draft addendum to the Toxicological Review of Methanol (Non-Cancer) begins June 22, 2011, and ends July 6, 2011. Comments should be in writing and must be received by EPA by July 6, 2011.

The peer review panel workshop on the Toxicological Review of Methanol (Non-Cancer) will be held on July 22, 2011, beginning at 8:30 a.m. and ending at 5 p.m. Eastern Time.

ADDRESSES: Back to Top

The draft addendum to the “Toxicological Review of Methanol (Non-Cancer): 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 peer review workshop on the draft Toxicological Review of Methanol (Non-Cancer) will be held at Hilton Raleigh-Durham Airport at Research Triangle Park, 4810 Creek Lane, Durham, NC 27703. To attend the workshop, register no later than July 15, 2011, by calling Eastern Research Group, Inc., at 781-674-7374 or toll free at 800-803-2833 (ask for the Methanol peer review coordinator, Laurie Waite); sending a facsimile to 781-674-2906 (reference the “Methanol Peer Review Workshop” and include your name, title, affiliation, full address and contact information), or sending an e-mail to meetings@erg.com (reference the “Methanol Peer Review Workshop” and include your name, title, affiliation, full address and contact information). You can also register via the Internet at https://www2.ergweb.com/projects/conferences/peerreview/register-toxmethanol.htm. Space is limited, and reservations will be accepted on a first-come, first-served basis. There will be a limited time at the peer review workshop for comments from the public. Please inform ERG if you wish to make comments during the workshop.

Information on Services for Individuals with Disabilities: EPA welcomes public attendance at the “Methanol Peer Review Workshop” and will make every effort to accommodate persons with disabilities. For information on access or services for individuals with disabilities, contact ERG, 110 Hartwell Avenue, Lexington, MA 02421-3136 by calling 781-674-7374 or toll free at 800-803-2833 (ask for the Methanol peer review coordinator, Laurie Waite); sending a facsimile to 781-674-2906 (reference the “Methanol Peer Review Workshop” and include your name and contact information), or sending an e-mail to meetings@erg.com (reference the “Methanol Peer Review Workshop” and include your name and contact information).

Additional Information

For information on the draft assessment, please contact Jeffrey Gift, PhD, U.S. Environmental Protection Agency, National Center for Environmental Assessment, Mail Code B243-01, 109 T.W. Alexander Drive, Durham, NC 27711; telephone: 919-541-4828; facsimile: 919-541-0245; or e-mail: gift.jeff@epa.gov.

SUPPLEMENTARY INFORMATION: Back to Top

I. Information About IRIS Back to Top

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 Back to Top

Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2009-0398, 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-2009-0398. 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://www.regulations.gov or in hard copy at the OEI Docket in the EPA Headquarters Docket Center.

Dated: June 10, 2011.

David Bussard,

Acting Director, National Center for Environmental Assessment.

[FR Doc. 2011-15631 Filed 6-21-11; 8:45 am]

BILLING CODE 6560-50-P

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