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Notice

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

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of public comment period and listening session.

SUMMARY:

EPA is announcing a 60-day public comment period and listening session for the external 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). The draft assessment was prepared by the National Center for Environmental Assessment (NCEA) within the EPA Office of Research and Development (ORD). EPA is releasing this draft assessment solely for the purpose of pre-dissemination peer review 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.

In January 2010, EPA released an external peer review draft IRIS Toxicological Review for methanol (EPA/635/R-09/013), containing both cancer and non-cancer analyses, and requested that the Science Advisory Board conduct a review of this human health assessment. Following a report from the National Toxicology Program, EPA placed the external peer review of the draft IRIS Methanol Toxicological Review on hold. The National Toxicology Program report recommended that pathology reviews be carried out to resolve differences of opinion in the diagnoses of certain tumors reported in a Ramazzini Institute methanol research study, which was cited and used to support some of the conclusions in the draft IRIS assessment. As a result, EPA and the National Institute of Environmental Health Sciences plan to jointly sponsor an independent Pathology Working Group (PWG) review of select studies conducted at the Institute. EPA is today releasing the draft IRIS Methanol Toxicological Review (Non-Cancer) for public comment while continuing to hold the cancer assessment that was previously released in January 2010. The data and studies used in the draft IRIS Methanol Toxicological Review (Non-Cancer) are unrelated to the tumor diagnoses being re-examined by the PWG. The information, analyses and conclusions of the draft assessment announced in this notice are identical to the non-cancer portions of the draft assessment previously released in January 2010. Comments relevant to the non-cancer methanol assessment that were received during the previous public comment period for the joint cancer and non-cancer assessment will be considered along with new comments.

An EPA listening session will be held on May 26, during the public comment period for this draft assessment. The purpose of the listening session is to allow all interested parties to present scientific and technical comments on the draft IRIS health assessment to EPA and other interested parties attending the listening session. EPA welcomes the comments that will be provided to the Agency by the listening session participants. The comments will be considered by the Agency as it revises the draft assessment after the external peer review. EPA will compile a list of meeting participants, including the name, principal affiliation, and sponsor of each person attending or calling in to the meeting. The list of listening session participants as well as presentations and written materials given to NCEA will be made a part of the public record.

After public review and comment, an EPA contractor will hold a meeting of expert panelists for independent external peer review of this draft assessment. The public comment period and external peer review meeting are separate processes that provide opportunities for all interested parties to comment on the assessment. The external peer review meeting, to be scheduled at a later date, will be open to the public and announced in the Federal Register. Public comments submitted during the public comment period will be provided to the external peer reviewers before the panel meeting and considered by EPA in the disposition of public comments. Public comments received after the public comment period closes will not be submitted to the external peer reviewers and will only be considered by EPA if time permits.

DATES:

The public comment period begins April 18, 2011, and ends June 17, 2011. Comments should be in writing and must be received by EPA by June 17, 2011.

The listening session on the draft assessment for methanol will be held on May 26, beginning at 9 a.m. and ending at 4 p.m., Eastern Time. Interested parties who wish to attend the listening session should register no later than May 19. If you wish to present at the listening session, indicate in your registration that you would like to make oral comments and provide the length of your presentation. To register to speak and/or listen send an e-mail to IRISListeningSession@epa.gov (subject line: Methanol Listening Session); call Christine Ross at 703-347-8592; or fax a registration request to 703-347-8689. Please reference the “Methanol Listening Session” and include your name, title, affiliation, sponsor information, full address and contact information. Indicate if you will need audio-visual equipment (e.g., laptop computer and slide projector). In general, each presentation should be no more than 30 minutes. If, however, there are more requests for presentations than the allotted time allows, then the time limit for each presentation will be adjusted. A copy of the agenda for the listening session will be available at the meeting. If no speakers have registered by May 19, the listening session will be cancelled, and EPA will notify those registered of the cancellation.

ADDRESSES:

The draft “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 Start Printed Page 21737Management 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 listening session on the draft assessment for methanol will be held at the EPA offices at Potomac Yard North Building, N-7100, 2733 South Crystal Drive, Arlington, Virginia 22202. Please note that to gain entrance to this EPA building to attend the Methanol Listening Session, you must have photo identification and must register at the guard's desk in the lobby. The guard will retain your photo identification and will provide you with a visitor's badge. At the guard's desk, you should provide the name Christine Ross and the telephone number 703-347-8592 to the guard on duty. The guard will contact Ms. Ross who will meet you in the reception area to escort you to the meeting room. When you leave the building, please return your visitor's badge to the guard and you will receive your photo identification.

A teleconference line will also be available for registered attendees/speakers. The teleconference number is 866-299-3188, and the access code is 926-378-7897, followed by the pound sign (#). The teleconference line will be activated at 8:45 a.m., and you will be asked to identify yourself and your affiliation and sponsors at the beginning of the call.

Information on Services for Individuals with Disabilities: EPA welcomes public attendance at the Methanol Listening Session and will make every effort to accommodate persons with disabilities. For information on access or services for individuals with disabilities, please contact Christine Ross by phone at 703-347-8592 or by e-mail at IRISListeningSession@epa.gov. To request accommodation for a disability, please contact Ms. Ross, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request.

Additional Information: For information on the docket, http://www.regulations.gov, or the public comment period, 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.

For information on the Methanol Listening Session, please contact Christine Ross, IRIS Staff, National Center for Environmental Assessment (Mail Code: 8601P), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone: 703-347-8592; facsimile: 703-347-8689; or e-mail: IRISListeningSession@epa.gov.

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.

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SUPPLEMENTARY INFORMATION:

I. Information About IRIS

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

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 Start Printed Page 21738submit 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.

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Dated: March 28, 2011.

Darrell A. Winner,

Acting Director, National Center for Environmental Assessment.

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[FR Doc. 2011-9293 Filed 4-15-11; 8:45 am]

BILLING CODE 6560-50-P