[Federal Register Volume 70, Number 42 (Friday, March 4, 2005)]
[Notices]
[Pages 10616-10620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4275]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-7880-9]


Integrated Risk Information System (IRIS); Announcement of 2005 
Program; Request for Information

AGENCY: Environmental Protection Agency.

ACTION: Notice; announcement of IRIS 2005 program agenda and request 
for scientific information on human health effects that may result from 
exposure to chemical substances.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing 
the IRIS 2005 agenda and requesting scientific information on health 
effects that may result from exposure to the chemical substances for 
which EPA is starting assessments this year.
    The Integrated Risk Information System (IRIS) is an EPA database 
that contains the Agency's scientific consensus positions on human 
health effects that may result from exposure to chemical substances in 
the environment. On February 9, 2004 (69 FR 5971), EPA announced the 
2004 IRIS agenda, with solicitation of scientific information from the 
public for consideration in assessing health effects from specific 
chemical substances. All assessments currently in progress or completed 
in 2004 are listed in this notice. This notice also provides an update 
on EPA's efforts to improve the IRIS database.

DATES: Please submit any scientific information in response to this 
notice in accordance with the instructions provided at the end of this 
notice by May 3, 2005.

ADDRESSES: Please submit relevant scientific information identified by 
docket ID number ORD-2003-0016, online at http://www.epa.gov/edocket 
(EPA's preferred method); by e-mail to [email protected]; mailed to 
EPA Docket Center, Environmental Protection Agency, Mailcode: 2822T, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; or by hand 
delivery or courier to EPA Docket Center, EPA West, Room B102, 1301 
Constitution Ave., NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. 
Monday through Friday, excluding legal holidays. Comments on a disk or 
CD-ROM should be formatted in Wordperfect or ASCII file, avoiding the 
use of special characters and any form of encryption, and may be mailed 
to the mailing address above.

FOR FURTHER INFORMATION CONTACT: For information on the IRIS program, 
contact Amy Mills, 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: (202) 564-3204, facsimile: (202) 565-0075; or e-mail: 
[email protected].
    For general questions about access to IRIS, or the content of IRIS, 
please call the IRIS Hotline at (202) 566-1676 or send electronic mail 
inquiries to [email protected].

SUPPLEMENTARY INFORMATION: 

Background

    IRIS is an EPA database containing Agency scientific positions on 
potential adverse human health effects that may result from exposure to 
chemical substances found in the environment.\1\ IRIS currently 
provides information on health effects associated with more than 500 
chemical substances.
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    \1\ 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.
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    The database includes chemical-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. Combined with specific

[[Page 10617]]

situational exposure assessment information, the information in IRIS 
may be used as a source in evaluating potential public health risks 
from environmental contaminants.
    EPA's overall process for developing IRIS assessments consists of: 
(1) An annual Federal Register announcement of EPA's IRIS agenda and 
call for scientific information from the public on selected chemical 
substances; (2) a search of the scientific literature; (3) development 
of IRIS summaries and support documents; (4) agency review; (5) 
external peer review; (6) management review and approval; and (7) entry 
of IRIS summaries and support documents into the IRIS database (http://www.epa.gov/iris).

The IRIS Annual Agenda

    Each year, EPA develops a list of priority chemical substances and 
an annual agenda for the IRIS program. EPA uses four general criteria 
to set these priorities: (1) EPA statutory, regulatory, or program-
specific implementation needs; (2) availability of new scientific 
information or methodology that might significantly change the current 
IRIS information; (3) interest to other levels of government or the 
public; and (4) availability of other scientific assessment documents 
and only a modest additional effort would be needed to complete the 
review and documentation for IRIS. The decision to assess any given 
chemical substance hinges on available Agency resources. Availability 
of risk assessment guidance, guidelines, and science policy decisions 
may also have an effect on the timing of EPA's decision to assess a 
chemical substance.
    Consistent with previous Federal Register notices announcing the 
annual IRIS agenda, EPA is soliciting public involvement in new 
assessments starting in 2005. While EPA conducts a thorough literature 
search for each chemical substance, there may be unpublished studies or 
other primary technical sources that we may not otherwise obtain 
through open literature searches. We would appreciate receiving 
scientific information from the public during the information gathering 
stage for the list of new assessments provided in this notice. 
Interested persons should provide scientific analyses, studies, and 
other pertinent scientific information. Also note, if you have 
submitted information previously to the IRIS Submission Desk, there is 
no need to resubmit that information. While EPA is primarily soliciting 
information on new 2005 assessments announced in this notice, the 
public may submit information on any chemical substance at any time.
    This notice provides: (1) A list of IRIS assessments completed in 
2004; (2) a list of IRIS assessments in progress; (3) a list of new 
IRIS assessments starting in 2005; (4) an update on EPA's effort to 
search for new scientific studies on IRIS chemicals; (5) an update on 
other improvements underway in the IRIS program; and (6) instructions 
to the public for submitting scientific information to EPA pertinent to 
the development of new IRIS assessments.

Assessments Completed in 2004

    The following assessments were completed and entered into IRIS in 
2004 and early 2005. These assessments were listed in the Federal 
Register of February 9, 2004 (69 FR 5971). All health endpoints 
associated with chronic exposure, cancer and noncancer, were assessed 
unless otherwise noted. Where information was available, both 
qualitative and quantitative assessments were developed.

------------------------------------------------------------------------
                      Substance name                           CAS No.
------------------------------------------------------------------------
boron.....................................................    7440-42-8
ethylene dibromide (1,2-dibromoethane)....................     106-93-4
lead (updated qualitative discussion).....................    7349-92-1
2-methylnaphthalene.......................................      91-57-6
perchlorate and perchlorate salts.........................    7790-98-9
                                                              7791-03-9
                                                              7778-74-7
                                                              7601-89-0
------------------------------------------------------------------------

Assessments in Progress

    The following assessments are underway. Each was listed in the 2004 
IRIS agenda. The status and planned milestone dates for each assessment 
can be found on the IRIS Track system, accessible from the IRIS 
database. All health endpoints due to chronic exposure, cancer and 
noncancer, are being assessed unless otherwise noted. For all endpoints 
assessed, both qualitative and quantitative assessments are being 
developed where information is available. Those denoted with an 
asterisk (*) may require additional time for analysis or peer review 
due to their large databases or complex assessment issues. Substances 
denoted with a double asterisk (**) are being evaluated for effects 
from acute and/or other less-than-lifetime exposure durations. These 
substances are part of a pilot test to evaluate the application of 
methods, procedures, and resource needs for adding health effects 
information for less-than-lifetime exposure duration to IRIS.

------------------------------------------------------------------------
         Substance name                           CAS No.
------------------------------------------------------------------------
acetaldehyde....................  75-07-0
acrolein**......................  107-02-8
acrylamide......................  79-06-1
acrylonitrile...................  107-13-1
aldicarb/aldicarb sulfoxide.....  116-06-3/1646-87-3
aldicarb sulfone................  1646-88-4
arsenic.........................  7440-38-2
asbestos (noncancer effects)*...  1332-21-4
benzene**.......................  71-43-2
benzo(a)pyrene..................  50-32-8
beryllium (cancer effects)......  7440-41-7
bromobenzene....................  108-86-1
bromodichloromethane............  75-27-4
bromoform.......................  75-25-2
cadmium.........................  7440-43-9
carbon tetrachloride............  56-23-5
chloroethane....................  75-00-3
chloroform (inhalation route)...  67-66-3
chloroprene.....................  126-99-8
cobalt..........................  7440-48-4
copper..........................  7440-50-8
cryptosporidium.................  [n.a.]

[[Page 10618]]

 
dibromochloromethane............  124-48-1
dibutyl phthalate (chronic; less- 84-74-2
 than-lifetime** exposures).
1,2-dichlorobenzene.............  95-50-1
1,3-dichlorobenzene.............  541-73-1
1,4-dichlorobenzene.............  106-46-7
1,2-dichloroethylene............  540-59-0
di(2-ethylhexyl)adipate (DEHA)..  103-23-1
di(2-ethylhexyl)phthalate.......  117-81-7
1,4-dioxane.....................  123-91-1
ethanol.........................  64-17-5
ethyl tertiary butyl ether......  637-92-3
ethylbenzene....................  100-41-4
ethylene dichloride.............  107-06-2
ethylene glycol monobutyl ether   111-76-2
 (cancer effects).
ethylene oxide (cancer effects;   75-21-8
 noncancer acute** exp.).
formaldehyde*...................  50-00-0
hexachlorobutadiene.............  87-68-3
hexachloro- cyclopentadiene**...  77-47-4
hexahydro-1,3,5- trinitro-        121-82-4
 triazine (RDX)*.
n-hexane........................  110-54-3
hydrogen cyanide................  74-90-8
hydrogen sulfide**..............  7783-06-4
isopropanol.....................  67-63-0
kepone..........................  143-50-0
methanol........................  67-56-1
methyl tert-butyl ether (MTBE)..  1634-04-4
methylene chloride..............  75-09-2 (dichloromethane)
mirex...........................  2385-85-5
naphthalene (cancer effects,      91-20-3
 inhalation route).
nickel (soluble salts)..........  [n.a.--various]
nitrobenzene....................  98-95-3
PAH mixtures....................  [n.a.--various]
pentachlorophenol...............  87-86-5
perfluorooctanoic acid--ammonium  3825-26-1
 salt (PFOA).
perfluorooctane sulfonate--       2795-39-3
 potassium salt (PFOS).
phosgene (chronic; acute**        75-44-5
 exposure).
polybrominated diphenyl ethers    [n.a.--various]
 (tetra, penta, hexa, deca-PDEs).
polychlorinated biphenyls (PCBs)  1336-36-3
 (noncancer endpoints).
propionaldehyde.................  123-38-6
refractory ceramic fibers.......  [n.a.]
styrene.........................  100-42-5
2,3,7,8-TCDD (dioxin)*..........  1746-01-6
tetrachloroethylene               127-18-4
 (perchloroethylene).
tetrahydrofuran.................  109-99-9
thallium........................  7440-28-0
toluene.........................  108-88-3
trichloroacetic acid............  76-03-9
1,1,1-trichloroethane (chronic;   71-55-6
 less-than-lifetime** exp.).
trichloroethylene*..............  79-01-6
1,2,3-trichloropropane..........  96-18-4
2,2,4-trimethylpentane..........  540-84-1
uranium compounds...............  [n.a.--various]
vinyl acetate...................  108-05-4
zinc and compounds..............  7440-66-6
------------------------------------------------------------------------

    IRIS summaries and support documents for all substances listed as 
on-going assessments in 2005 will be provided on the IRIS Web site at 
http://www.epa.gov/iris as they are completed. This publicly available 
Web site is EPA's primary location for IRIS documents. In addition, 
external peer review drafts of IRIS assessments can be found during 
their peer review periods via the Recent Additions page of the IRIS Web 
site. Interested parties should check the ``Recent Additions'' page 
frequently for the availability of these drafts.

Information Requested on New Assessments for 2005

    EPA will continue building and updating the IRIS database. The 
Agency recognizes that a number of the assessments on IRIS need 
updating to incorporate new scientific information and methodologies. 
Further, many additional substances are candidates for adding to IRIS. 
However, due to limited resources in the Agency to address the spectrum 
of needs, priorities are set based on specific considerations.
    EPA developed the list of priority chemicals for 2005 by sorting 
chemical nominations from the EPA programs and the public according to 
the following considerations: (1) Multiple nominations were received 
for a chemical from EPA programs and in response to the August 2003 
Federal Register notice requesting public nominations (68 FR 48359); 
(2) nominations demonstrated more than one of the following: (a) 
Statutory, regulatory or programmatic need, (b) interest to other 
levels of government or the public, and (c) availability of other 
assessment documents for use in developing an IRIS assessment. To

[[Page 10619]]

refine the list of nominations, high priority was given to EPA 
programs' priority nominations; (3) nominations for which significant 
new health effects information is available on which to base an 
assessment; and (4) nominations for which Agency resources are 
available to conduct the assessment. Available health effects 
information and EPA resources are considered critical for selecting a 
chemical for assessment.
    Based on EPA's prioritization process described above, the 
following IRIS health assessments have been selected for initiation in 
2005. The primary reasons for selecting each chemical substance are 
indicated. ``CAA need'' refers to EPA's responsibilities under the 
Clean Air Act; ``CERCLA need'' refers to EPA's responsibilities under 
the Comprehensive Environmental Response, Compensation and Liability 
Act, or Superfund. ``RCRA need'' refers to EPA's responsibilities under 
the Resource Conservation and Recovery Act.
    The Agency is requesting information from the public for 
consideration in the development of these assessments. For all 
endpoints assessed, both qualitative and quantitative assessments will 
be developed where information is available.

----------------------------------------------------------------------------------------------------------------
          Substance name                       CAS No.                          Reason for selection
----------------------------------------------------------------------------------------------------------------
butyl benzyl phthalate............  85-68-7......................  CERCLA site cleanup and RCRA need. Newer
                                                                    scientific information is available to
                                                                    update older assessment.
cerium............................  1306-38-3....................  CAA need. Scientific information is available
                                                                    to develop a first IRIS assessment.
hexachloroethane..................  67-72-1......................  CERCLA site cleanup need. Newer scientific
                                                                    information is available to update older
                                                                    assessment.
2-hexanone........................  591-78-6.....................  CERCLA site cleanup and RCRA need. Scientific
                                                                    information is available to develop a first
                                                                    IRIS assessment.
naphthalene (non-cancer)..........  91-20-3......................  CERCLA site cleanup need. Newer scientific
                                                                    information is available to update older
                                                                    assessment.
platinum..........................  7440-06-4....................  CAA need. Scientific information is available
                                                                    to develop a first IRIS assessment.
1,1,2,2-tetrachloroethane.........  79-34-5......................  CAA need. Newer scientific information is
                                                                    available to update older assessment.
----------------------------------------------------------------------------------------------------------------

Systematic Update of the IRIS Database

    While the annual prioritization process responds to the needs 
expressed by IRIS users, EPA is also systematically updating the IRIS 
database. The IRIS Program is conducting a screening-level review of 
the available scientific literature for all chemicals in the IRIS 
database that are not under active reassessment. The purpose of EPA's 
screening level review is to reach preliminary determinations regarding 
the likelihood that a full reassessment based on an evaluation of new 
health effects literature could potentially result in significant 
changes to existing toxicity values or cancer weight-of-evidence 
designations. The process consists of a preliminary search and review 
of the literature through standard toxicological bibliographic 
databases (titles and abstracts) and selected literature compilations 
to identify new major studies that have become available since the 
existing IRIS assessment was completed. Screening-level reviews were 
completed for 460 chemicals in the IRIS database in 2004, that is, 
essentially all chemicals in the database with the exception of those 
that are on the current IRIS agenda and are being fully reassessed. For 
the chemicals reviewed, no major new health effects studies were found 
that would be likely to significantly change existing toxicity values 
for about 63% of the chemicals. These findings have been added to the 
``EPA Review and Documentation'' sections of individual IRIS Summaries. 
The literature screen has been re-initiated in 2005 to continuously 
check the availability of new literature and note findings in the IRIS 
database.
    As planned and discussed in the previous annual agenda, EPA is 
using findings from this literature screen as a basis for 
systematically updating IRIS by performing a more in-depth review of 
the extant health data. This more in-depth review is verifying results 
from the IRIS literature screening review. For those chemicals 
confirmed to be without new health information to change the existing 
assessment, EPA is updating IRIS Summaries to indicate that the 
scientific information upon which the assessment was based is still 
current. Twelve assessments were updated with this information in 2004, 
30 are in progress for 2005.
    We continue to request the submission of any scientific information 
that you would like EPA to consider in confirming the results of the 
literature screening review and literature screen verification. You can 
locate the results for a chemical assessment on the IRIS Web site 
(http://www.epa.gov/iris) by selecting the specific IRIS Summary of 
interest.

Other Improvements to the IRIS Program--Update

    As discussed in the Federal Register notice announcing the 2004 
agenda, EPA has taken steps to improve the IRIS program and its 
products through a series of program reforms. EPA has expanded its 
central IRIS Staff to better manage the program and ensure scientific 
quality and consistency. In addition, external scientific peer reviews 
are being conducted by panel meetings rather than by mail reviews. This 
step is being taken to provide the best possible scientific review of 
each assessment. Further, EPA is now positioning the external peer 
review at the end of each IRIS assessment review process, strengthening 
the role of peer review in informing the outcome of the process. A 
public comment period is now standard practice prior to panel peer 
review meetings, and the meetings are open to the public for 
observation. These steps have been taken to facilitate scientific input 
from the public and to make the peer review process more transparent. 
These steps require extra time to implement, and therefore will result 
in somewhat longer time frames for completion of IRIS assessments.
    As mentioned previously in this notice, in 2004 EPA implemented a 
new publically available tracking system for IRIS assessments in 
progress. IRIS Track provides the status and planned milestones in the 
development and review process for each assessment. The system was put 
in place to provide more information and transparency for IRIS users. 
IRIS Track is kept continually updated. It can be accessed from the 
IRIS home page.

[[Page 10620]]

General Information

A. How Can I Get Copies of Related Information?

    EPA has established an official public docket for this action under 
Docket ID No. ORD 2003-0016. 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 B102, 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, and the 
telephone number for the OEI Docket is (202) 566-1752.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system. EPA Dockets at 
http://www.epa.gov/edocket/ may be used to submit or view public 
submissions, 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,'' 
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, CBI, or other information whose disclosure is 
restricted by statute. Information claimed as CBI and other information 
whose disclosure is restricted by statute is 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 Scientific Information?

    Scientific information may be submitted as provided in the 
ADDRESSES section. Please submit scientific information within 60 days 
of this notice, provide all information (studies, reports, articles, 
etc.) you wish to submit. Please ensure that your submissions are 
submitted within the specified period. Information received after the 
close of the submission period will be marked late, and may be 
considered if time permits. Your submission should specify the chemical 
substance to which your information pertains, CASRN (Chemical Abstract 
Service Registry Number), and the topic or aspect of the assessment 
that is being addressed (e.g., carcinogenicity, mode of action). In 
addition, when you submit results of new health effects studies 
concerning existing substances on IRIS, you should include a specific 
explanation of how the study results could change the information in 
IRIS. All citations should be listed in scientific citation format, 
that is, author(s), title, journal, and date. Include names, addresses 
and telephone numbers of person(s) to contact for additional 
information.
    If you submit electronic information, EPA recommends that you 
include your name, mailing address, and an e-mail address or other 
contact information in the body of your submission and with any disk or 
CD ROM 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.
    Your use of EPA's electronic public docket to submit information to 
EPA electronically is EPA's preferred method for receiving submissions. 
The electronic public docket system is an ``anonymous access'' system, 
which means EPA will not know your identity, e-mail 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 (e-mail) system is not an ``anonymous access'' system. 
If you send e-mail 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.
    You may also request to augment your submission with a scientific 
briefing to EPA staff. Such requests should be made directly to Amy 
Mills, IRIS Program Director (see FOR FURTHER INFORMATION CONTACT).

    Dated: February 28, 2005.
Peter Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. 05-4275 Filed 3-3-05; 8:45 am]
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