E6-19558. Draft Toxicological Reviews of Cyanobacterial Toxins: Anatoxin-a, Cylindrospermopsin and Microcystins LR, RR, YR and LA

AGENCY:

Environmental Protection Agency.

ACTION:

Notice of public comment period and external peer-review panel meeting.

SUMMARY:

The U.S. Environmental Protection Agency (EPA) is announcing a forty-five day public comment period and an external peer-review panel meeting to review the external review draft documents entitled, “Toxicological Reviews of Cyanobacterial Toxins: Anatoxin-a, Cylindrospermopsin and Microcystins LR, RR, YR and LA” (NCEA-C-1743, NCEA-C-1763 and NCEA-C-1765). Cyanobacteria, commonly referred to as blue-green algae, are found in freshwater, estuarine and marine environments. Cyanobacteria, other freshwater algae, and their toxins are included as microbial contaminants on EPA's Office of Water (OW) Contaminant Candidate List (CCL). These draft assessments discuss potential human health effects of exposure to these cyanobacterial toxins for four durations—acute, short-term, subchronic and chronic— focusing on noncancer effects due to oral exposure.

The public comment period and the external peer review are separate processes that provide opportunities for all interested parties to comment on these documents. These documents were prepared by EPA's National Center for Environmental Assessment (NCEA) within EPA's Office of Research and Development. EPA will use comments and recommendations from the public and the expert panel meeting to finalize the draft documents. EPA is releasing these draft documents solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. These documents have not been formally disseminated by EPA. They do not represent and should not be construed to represent any Agency policy or determination.

DATES:

The public comment period will begin on November 20, 2006 and continue until January 4, 2007. The public may submit comments via Regulations.gov (see SUPPLEMENTARY INFORMATION below). The peer-review panel meeting will begin on January 10, 2007, at 9 a.m. and will end at 5 p.m. The public may attend the peer-review panel meeting and are invited to provide oral statements at the commencement of the meeting (for more information refer to the instructions for registration below).

ADDRESSES:

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 panel meeting to review these draft documents. The external peer-review panel meeting will be held at EPA's Andrew W. Breidenbach Environmental Research Center (AWBERC) located at 26 W. Martin Luther King Drive, Cincinnati, OH. Observers may attend the peer review meeting by filling out the form found on the Web site, https://www2.ergweb.com/​projects/​conferences/​ncea/​toxin.htm, by calling Eastern Research Group, Inc.'s conference line between the hours of 9 a.m. and 5:30 p.m. EST at [phone] or toll free at [phone], or by faxing a registration request to [phone] (include full address and contact information). Pre-registration will begin December 15, 2006. Pre-registration is strongly recommended as space is limited, and registrations will be accepted on a first-come, first-served basis. The deadline for online pre-registration is January 3, 2007. Telephone and fax registrations will continue to be accepted after this date, as will on-site registration, if space allows. Public comments submitted to Regulations.gov by December 29, 2006, will be provided to the external peer review panel prior to the meeting.

The draft “Toxicological Reviews of Cyanobacterial Toxins: Anatoxin-a, Cylindrospermopsin and Microcystins LR, RR, YR and LA” are available primarily via the Internet on the National Center for Environmental Assessment's 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 Technical Information Staff (TIS) at NCEA's Cincinnati office; telephone: [phone]; facsimile: [phone]. If you are requesting a paper copy, please provide your name, mailing address, and title of these documents. Copies are not available from Eastern Research Group, Inc.

FOR FURTHER INFORMATION CONTACT:

Questions regarding information about, registration, and logistics for the external peer review workshop should be directed to Eastern Research Group, Inc., 110 Hartwell Avenue, Lexington, MA 02421-3136 beginning December 15, 2006; telephone: [phone] or toll free at [phone]; facsimile: [phone]; or e-mail: [e-mail].

If you have questions about the draft documents, contact Belinda Hawkins, National Center for Environmental Assessment, 26 W. Martin Luther King Drive (A-110), Cincinnati, OH; telephone: [phone]; facsimile: [phone]; e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

EPA has established an official public docket for this action under docket ID number EPA-HQ-ORD-2006-0939. The official public docket consists of the documents referenced in this notice and a list of charge questions that have been submitted to the external peer reviewers. All documents are available on the Internet at http://www.regulations.gov by using the search function and corresponding docket identification number.

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

Note:

The EPA Docket Center suffered damage due to flooding during the last week of June 2006. The Docket Center is continuing to operate. However, during the cleanup, there will be temporary changes to Docket Center telephone numbers, addresses, and hours of operation for people who wish to make hand deliveries or visit the Public Reading Room to view documents. Consult EPA's Federal Register notice at 71 FR 38147 (July 5, 2006) or the EPA Web site at http://www.epa.gov/​epahome/​dockets.htm for current information on docket operations, locations and telephone numbers. The Docket Center's mailing address for U.S. mail and the procedure for submitting comments to http://www.regulations.gov are not affected by the flooding and will remain the same.

Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2006-0939 by one of the following methods:

• http://www.regulations.gov: Follow the on-line instructions for submitting comments.
• E-mail: ORD [e-mail].
• Fax: [phone].
• 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 [phone].
• Hand Delivery: The OEI Docket is located in the EPA Headquarters Docket Center, 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 [phone]. 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 in hard copy, 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-2006-0939. 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 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.

Dated: November 13, 2006.

Peter W. Preuss,

Director, National Center for Environmental Assessment.