Federal Register: April 25, 2008 (Volume 73, Number 81)
DOCID: fr25ap08-54 FR Doc E8-8885
ENVIRONMENTAL PROTECTION AGENCY
Environmental Protection Agency
FRL ID: [FRL-8556-4; Docket ID No. EPA-HQ-ORD-2007-0664]
ACTION: Guidance for Industry; Availability:
DOCUMENT ACTION: Notice; Announcement of availability of literature searches for IRIS assessments; request for information.
Integrated Risk Information System (IRIS); Announcement of Availability of Literature Searches for IRIS Assessments
The U.S. Environmental Protection Agency (EPA) is announcing the availability of literature searches for three IRIS assessments, manganese (CAS No. 74399), 1,2,4 trimethylbenzene (CAS No. 95636), and 1,3,5trimethylhenzene (CAS No. 108678) that may be started in 2008, and requesting scientific information on health effects that may result from exposure to these chemical substances. The Integrated Risk Information System (IRIS) is an EPA database that contains information on human health effects that may result from chronic exposure to chemical substances in the environment.
EPA will accept information related to the specific substances included herein as well as any other compounds being assessed by the IRIS Program. Please submit any information in accordance with the instructions provided below.
Integrated Risk Information System Assessments; Availability of Literature Searches for IRIS Assessments,
IRIS is a database of human health effects that may result from chronic exposure to various chemical substances found in the environment. (EPA notes that information in the IRIS database has no preclusive effect and does not predetermine the outcome of any rulemaking. When EPA uses such information to support a rulemaking, the scientific basis for, and the application of that information are subject to comment.) IRIS currently provides information on the chronic health effectsboth cancer and noncancerassociated with more than 500 chemical substances.
The database includes chemicalspecific summaries of qualitative and quantitative health information in support of the first two steps of the risk assessment process, i.e., hazard identification and dose response evaluation. Combined with specific situational exposure assessment information, the information in IRIS is an important source in evaluating potential public health risks from environmental contaminants.
The IRIS Annual Agenda
The 2008 IRIS agenda was announced in a Federal Register Notice (FRN) of December 21, 2007, which can be found on the IRIS Web site at http://www.epa.gov/iris. The December 21, 2007, FRN lists all ongoing IRIS assessments and 20 assessments that may start in 2008. EPA is conducting literature searches for these 20 chemicals. Based on the results of the literature searches and as EPA resources allow, assessments will be started for those chemicals with data that may support development of one or more toxicity values. With the December 21, 2007, IRIS agenda announcement, EPA also started a new process to actively solicit information from the public at the beginning of assessment development. As literature searches are completed, the results will he posted on the IRIS Web site (http://www.epa.gov/iris). The public is invited to review the literature search results and submit additional information to EPA. In conjunction with the December 21, 2007 FRN, EPA posted literature searches for 11 chemicals and stated that the availability of additional literature searches would be announced in subsequent FRNs.
Request for Public Involvement in IRIS Assessments
EPA is soliciting public involvement in assessments on the IRIS
agenda, including new assessments starting in 2008. While EPA conducts
a thorough literature search for each chemical substance, there may be
unpublished studies or other primary technical sources that are not
available through the open literature. EPA would appreciate receiving
scientific information from the public during the information gathering
stage for the assessments listed in this notice or any other
assessments on the IRIS agenda. Interested persons should provide
scientific analyses, studies, and other pertinent scientific
information. While EPA is primarily soliciting information on new assessments starting in 2008. the
public may submit information on any chemical substance at any time.
This notice provides: (1) A list of new IRIS assessments that may start in 2008 for which literature searches have recently become available; and (2) instructions to the public for submitting scientific information to EPA pertinent to the development of these assessments. EPA is also announcing the availability of additional literature searches on the IRIS Web site (http://www.epa.gov/iris). The public is invited to review the literature search results and submit additional information to EPA.
Literature searches are now available for manganese (CAS No. 7439 9), 1,2,4 trimethylbenzene (CAS No. 95636), and 1,3,5
trimethylbenzene (CAS No. 108678) at http://www.epa.gov/iris. Literature search results were provided on December 21, 2007, at http:/ /www.epa.gov/iris for tertamyl methyl ether, biphenyl, nbutanol, tertbutanol, carbonyl sulfide, diethyl phthalate, diisopropyl ether, hexabrornocyclodecane, weathered toxaphene, tungsten, and urea. Additional literature searches will be posted as they are completed, and their availability will be announced in the Federal Register. Instructions on how to submit information are provided below under General Information.
As of Monday, November 28, 2005, EPA's EDOCKET was replaced by the Federal Docket Management System (FDMS), the new federal government wide system. FDMS was created to provide a single point of access to all federal rulemaking activities. All materials previously found in EDOCKET are now available on the Internet at http:// www.regulations.gov.
A. How Can I Get Copies of Related Information?
EPA has established an official public docket for this action under Docket ID No. EPA HQORD20070664. The official public docket is the collection of materials that is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, 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) 5661744, and the telephone number for the OEI Docket is (202) 5661752.
An electronic version of the public docket is available through EPA's electronic public docket and comment system. EPA Dockets at http://www.regulations.gov may be used to submit or view public submissions, to access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select ``search,'' and then key in the appropriate docket identification number.
It is important to note that EPA's policy is that public submissions, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the submission contains copyrighted material, confidential business information (CBI), or other information whose disclosure is restricted by statute. Information claimed as CBI and other information whose disclosure is restricted by statute are not included in the official public docket or in EPA's electronic public docket. EPA's policy is that copyrighted material, including copyrighted material contained in a public comment, will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the EPA Docket Center.
B. How and To Whom Do I Submit Information?
Information on chemical substances listed in this notice may be submitted as provided in the ADDRESSES section. If you submit electronic information, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your submission and with any disk or CDROM you submit. This ensures that you can be identified as the submitter of the information and allows EPA to contact you in case EPA cannot read your information due to technical difficulties or needs further information on the substance of your submission. Any identifying or contact information provided in the body of submitted information will be included as part of the submission information that is placed in the official public docket and made available in EPA's electronic public docket. If EPA cannot read your information due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your information.
EPA's preferred method for receiving submissions is via EPA's
electronic public docket. The electronic public docket system is an
``anonymous access'' system, which means EPA will not know your
identity, email address, or other contact information unless you
provide it in the body of your submission. In contrast to EPA's
electronic public docket, EPA's electronic mail (email) system is not
an ``anonymous access'' system. If you send email directly to the
docket without going through EPA's electronic public docket, your e
mail address is automatically captured and included as part of the
submission that is placed in the official public docket and made available in EPA's electronic public docket.
Dated: April 15, 2008.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. E88885 Filed 42408; 8:45 am]
BILLING CODE 656050M
FOR FURTHER INFORMATION CONTACT
For information on the IRIS program, contact Dr. AbdelRazak Kadry, IRIS Program Director, National Center for Environmental Assessment, (Mail Code: 8601D), Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC 20460; telephone: (703) 3478545; facsimile: (703) 3478689; or email: firstname.lastname@example.org.
For general questions about access to IRIS, or the content of IRIS, please call the IRIS Hotline at (202) 5661676 or send electronic mail inquiries to email@example.com.