[Federal Register Volume 74, Number 202 (Wednesday, October 21, 2009)]
[Pages 54040-54042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25356]



[FRL-8970-7; Docket ID No. EPA-HQ-ORD-2009-0132]

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 


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: 202-566-1752; facsimile: 202-566-1753; or e-mail: 
[email protected]. 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: 919-541-4155, facsimile: 
919-541-1818; or e-mail: [email protected].



    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 
    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

[[Page 54041]]

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 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 (IRIS
           Substance name                posting date)         CASRN
barium..............................  cancer (1998).....       7440-39-3
bromoform...........................  RfD (1989), cancer         75-25-2
carbon disulfide....................  RfD (1990), RfC            75-15-0
chlorobenzene.......................  RfD (1989), cancer        108-90-7
2-chlorophenol......................  RfD (1988)........         95-57-8
o-cresol............................  RfD (1988), cancer         95-48-7
cumene..............................  RfD (1997), RfC            98-82-8
                                       (1997), cancer
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        118-74-1
selenium............................  RfD (1991), cancer       7782-49-2
1,1,2-trichloroethane...............  RfD (1988), cancer         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.

[[Page 54042]]

     E-mail: [email protected].
     Fax: 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 phone number is 202-
     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.
[FR Doc. E9-25356 Filed 10-20-09; 8:45 am]