E9-25356. Integrated Risk Information System (IRIS) Update Project; Announcement of 2009/2010 Agenda

AGENCY:

Environmental Protection Agency.

ACTION:

Notice of 2009/2010 IRIS Update Project and request for information.

SUMMARY:

The U.S. Environmental Protection Agency (EPA) is announcing the establishment of the Integrated Risk Information System (IRIS) Update Project. The purpose of the IRIS Update Project is to revisit a portion of the dose-response assessment values with a posting date on the IRIS database that is more than 10 years old. IRIS is an EPA data base containing human health risk information on possible adverse health effects that may result from chronic or long-term exposures to chemical substances found in the environment. This Federal Register notice (FRN) also announces the IRIS Update Project's 2009/2010 agenda and requests submission of new and relevant scientific information on health effects for the identified assessments listed in the Project's 2009/2010 agenda.

While EPA is not expressly soliciting comments on this notice, the Agency will accept information related to the substances included herein. Please submit any information in accordance with the instructions provided below.

DATES:

Information must be submitted within 60 days of the publication of this notice. The 60-day period begins October 21, 2009 and ends December 21, 2009. Technical comments should be in writing and must be received by EPA by December 21, 2009.

ADDRESSES:

Comments may be submitted electronically via http://www.regulations.gov,, by mail, by facsimile, or by hand delivery/courier. Please follow the detailed instructions provided in the SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT:

For information on the public comment period, contact the Office of Environmental Information Docket; telephone: [phone]; facsimile: 202-566-1753; or e-mail: [e-mail]. For information on the IRIS Update project, contact Dr. Chon Shoaf, National Center for Environmental Assessment, (mail code: B243-01), Office of Research and Development, U.S. Environmental Protection Agency, RTP, NC 27711; telephone: [phone], facsimile: 919-541-1818; or e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Background

The intent of the IRIS Update Project is to revisit all dose-response assessment toxicity values such as oral reference doses (RfDs), inhalation reference concentrations (RfCs), cancer oral slope factors, and cancer inhalation unit risks in IRIS with a posting or entry date more than 10 years old.

IRIS is a database of human health effects that may result from chronic exposure to various chemical substances or other contaminants found in the environment. IRIS currently provides information on health effects associated with more than 500 chemical substances. The database includes substance-specific 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. Also, IRIS has included detailed Toxicological Reviews as support documents since 1995. Government and private entities use IRIS, combined with specific exposure information, 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. IRIS is prepared and maintained by the EPA's National Center for Environmental Assessment within the Office of Research and Development.

While separate from the regular IRIS program, the IRIS Update Project draws on the IRIS data base as the source of human health assessments in need of update. The purpose of the IRIS Update Project is to replace existing IRIS assessment toxicity values and their supporting information that are more than 10 years old with new and relevant scientific information on health effects. As updated assessments are completed as part of this process, they will be posted on IRIS.

The IRIS Update Project defines “assessment” as an individual IRIS toxicity value along with its supporting information. For example, the Project identifies the values for an oral RfD, an inhalation RfC, and a cancer evaluation along with supporting information, as three assessments. Certain IRIS entries, however, may contain values that do not qualify for the update process. For example, a particular substance with an oral RfD derived 15 years ago would qualify for the update process, but a cancer evaluation derived 3 years ago for that same substance would not qualify. Also, the IRIS Update Project will not address any substances or toxicity values that are not currently on IRIS.

The IRIS Update Project's process consists of: (1) Publishing an annual Federal Register notice announcing EPA's IRIS Update Project agenda and calling for scientific information from the public regarding assessments on the agenda; (2) conducting a comprehensive search of the current scientific literature on each assessment; (3) developing draft health assessment documents using state of the science methods and guidelines; (4) conducting a combined simultaneous review of the draft assessment documents by EPA and other Federal Agencies via the Federal Standing Science Committee; (5) soliciting public comments on draft assessments, followed by independent external peer review under the Federal Advisory Committee Act (FACA); (6) preparing final IRIS assessments that reflect public comments and independent expert review; and (7) replacing the existing assessments with the final updated IRIS assessments on the IRIS data base (http://www.epa.gov/​iris).

This FRN describes only the first two steps of the update process. The literature and new data obtained in response to this FRN will be evaluated as to whether or not the assessment(s) can be completed within the resources and capacity of the IRIS Update Project. A subsequent FRN will announce the assessments proceeding through steps 3 through 6.

IRIS Update Agenda

Each year, EPA will develop a priority list of chemicals and an agenda of assessments to undergo the IRIS update process. EPA uses a variety of criteria to prioritize which assessments will be included on the agenda. General priority criteria include: Consideration of potential public health impact; EPA statutory, regulatory, or program-specific implementation needs; interest to other governmental agencies or the public; and availability of other scientific assessment documents that could serve as a basis for an update of an IRIS assessment. Specific priority criteria will take into consideration the frequency of occurrence in National Priority List (NPL) waste sites, occurrence as hazardous air pollutants used in residual risk assessments, and potential as a water pollutant based on the chemical contaminants list (CCL). The Update Project will strive to prevent duplication of effort with other assessment organizations. Thus, assessments currently on IRIS Track or assessments for pesticides that are available elsewhere within EPA have been eliminated from consideration for the IRIS Update Project.

EPA is soliciting public involvement in the process for those assessments on the IRIS Update Project's 2009/2010 agenda. While EPA conducts a thorough literature search for each assessment, 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. Interested persons should provide scientific analyses, studies, and other pertinent scientific information. This notice provides instructions for submitting scientific information to EPA pertinent to updating these assessments.

Assessments on 2009/2010 Agenda

The following IRIS assessments have been selected for inclusion in the IRIS Update Project agenda and are currently underway. The IRIS posting dates are provided to aid the submitter in determining whether information may have already been considered in the current online IRIS assessment.

Substance name	Assessment (IRIS posting date)	CASRN
barium	cancer (1998)	7440-39-3
bromoform	RfD (1989), cancer (1990)	75-25-2
carbon disulfide	RfD (1990), RfC (1995)	75-15-0
chlorobenzene	RfD (1989), cancer (1990)	108-90-7
2-chlorophenol	RfD (1988)	95-57-8
o-cresol	RfD (1988), cancer (1990)	95-48-7
cumene	RfD (1997), RfC (1997), cancer (1997)	98-82-8
1,1-dichloroethane	cancer (1990)	75-34-3
2,4-dimethylphenol	RfD (1990)	105-67-9
2,4-dinitrophenol	RfD (1991)	51-28-5
2,4-dinitrotoluene	RfD (1992)	121-14-2
hexachlorobenzene	RfD (1988), cancer (1991)	118-74-1
selenium	RfD (1991), cancer (1991)	7782-49-2
1,1,2-trichloroethane	RfD (1988), cancer (1994)	79-00-5
2,4,6-trichlorophenol	cancer (1990)	88-06-2

Information Requested on IRIS Update Assessments for 2009/2010

EPA is currently conducting literature searches for these assessments. The overall purpose of these literature searches is to identify new and relevant information for each assessment. Relevant information is that which improves the scientific understanding of the agent's toxicity in humans; new information is relevant information that is not included in the current online IRIS assessment. Based on the results of the literature searches and the information submitted in response to this announcement, EPA will evaluate assessments to determine whether they can be accommodated within the scope and resources of the IRIS Update Project.

With this IRIS update agenda announcement, EPA is actively soliciting information from the public at the beginning of the assessment update process. As literature searches are completed, they will be posted at http://www.regulations.gov for public inspection.

General Information

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

Submit your comments, identified by Docket ID No. EPA-HQ-ORD 2009-0132, by one of the following methods:

• http://www.regulations.gov: Follow the on-line instructions for submitting comments.
• E-mail: [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 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 an original 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-2009-0132. 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: 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 materials, such as copyrighted material, are 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: October 13, 2009.

Rebecca Clark,

Acting Director, National Center for Environmental Assessment.