[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.
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Substance name CAS No.
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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
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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.
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Substance name CAS No.
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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.]
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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
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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
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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.
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Substance name CAS No. Reason for selection
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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.
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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.
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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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