Integrated Risk Information System (IRIS); Announcement of 2005 Program; Request for Information, 10616-10620 [05-4275]
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10616
Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices
acute and chronic effects of chemical
treatments.
ERP No. D–FHW–E40802–MS Rating
EC1, I–69 Section of Independent Utility
#11 Project, Construction of Multi-Lane,
Interstate Highway from Benoit to
Robinsonville, US. Army COE Section
404 Permit, Mississippi River Bridge,
Bolivar, Coahoma, Tunica and
Sunflower Counties, MS.
Summary: EPA expressed
environmental concerns about the
proposed project related to water
resource impacts (wetlands, streams,
and floodplains), land use change/
habitat loss, and refining mitigation
commitments.
ERP No. D–FHW–H50002–NE Rating
LO, Bellevue Bridge Study, To Improve
Connectivity between the Omaha
Metropolitan Area and across the
Missouri River from U.S. 75 to I–29,
Coast Guard Permit, NPDES Permit, U.S.
Army COE
Section 10 and 404 Permits, Mills
County, IA and Sarpy County, NE.
Summary: EPA does not object to the
proposed project.
ERP No. D–UAF–G11053–NM Rating
LO, New Mexico Training Initiative,
Proposal to Modify the Training
Airspace New Cannon Air Force Base
(AFB), NM.
Summary: EPA does not object to the
proposed action.
ERP No. D–USN–E11054–FL Rating
EC2, Navy Air-To-Ground Training at
Avon Park Air Force Range, To Conduct
Air-to-Ground Ordnance Delivery and
Training, Fleet Forces Command’s Fleet
Readiness Training Program (FRTP),
Polk and Highlands Counties, FL.
Summary: EPA expressed
environmental concerns about wetland
and noise impacts.
ERP No. DA–ICC–J53004–MT Rating
EC2, Tongue River Railroad
Construction and Operation of the
Proposed Western Alignment Tongue
River III Southernmost Portion of the
41-mile Ashland to Decker Alignment,
Rosebud and Bighorn Counties, MT.
Summary: EPA expressed concern
about water quality, wetlands, Tribal
Trust resources, and indirect/
cumulative environmental impacts, and
requested additional information, data,
analysis, and discussion related to these
issues be included in the final EIS.
Final EISs
ERP No. F–IBR–K39085–CA San
Joaquin River Exchange Contractors
Water Authority—2005 to 2014, Water
Transfer Program, Stanislaus, San
Joaquin, Merced, Madera, Fresno, San
Benito, Santa Clara, Kern, and Kings
Counties, CA.
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Summary: EPA expressed continuing
concerns about impacts on water
quality, flow, and beneficial uses and
the relationship to proposed water
quality improvement measures.
ERP No. F–NPS–G65017–TX Rio
Grande Wild and Scenic River General
Management Plan, Implementation, Big
Bend National Park, Brewster and
Terrell Counties, TX.
Summary: No formal comment letter
was sent to the preparing agency.
ERP No. FS–FHW–E40325–NC
Western Section of the Winston-Salem
Northern Beltway, U.S. 158 north to
U.S. 52, TIP Nos. R–2247, Forsyth
County, NC.
Summary: EPA continues to express
concern due to aquatic stream habitat
impacts, water supply, watershed
impacts, and residential relocation
impacts.
Dated: March 1, 2005.
Robert W. Hargrove,
Director, NEPA Compliance Division, Office
of Federal Activities.
[FR Doc. 05–4254 Filed 3–3–05; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–7880–9]
Integrated Risk Information System
(IRIS); Announcement of 2005
Program; Request for Information
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.
AGENCY:
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
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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 https://www.epa.gov/edocket
(EPA’s preferred method); by e-mail to
oei.docket@epa.gov; 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:
mills.amy@epa.gov.
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
hotline.iris@epa.gov.
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.
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
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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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
(https://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 .........................................
ethylene dibromide (1,2dibromoethane) .....................
lead (updated qualitative discussion) .................................
2-methylnaphthalene ................
perchlorate and perchlorate
salts .......................................
7440–42–8
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7790–98–9
7791–03–9
7778–74–7
7601–89–0
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 lessthan-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.
CAS No.
acetaldehyde .................................................................................................................................................................
acrolein** .......................................................................................................................................................................
acrylamide .....................................................................................................................................................................
acrylonitrile ....................................................................................................................................................................
aldicarb/aldicarb sulfoxide .............................................................................................................................................
aldicarb sulfone .............................................................................................................................................................
arsenic ...........................................................................................................................................................................
asbestos (noncancer effects)* ......................................................................................................................................
benzene** ......................................................................................................................................................................
benzo(a)pyrene .............................................................................................................................................................
beryllium (cancer effects) ..............................................................................................................................................
bromobenzene ..............................................................................................................................................................
bromodichloromethane .................................................................................................................................................
bromoform .....................................................................................................................................................................
cadmium ........................................................................................................................................................................
carbon tetrachloride ......................................................................................................................................................
chloroethane .................................................................................................................................................................
chloroform (inhalation route) .........................................................................................................................................
chloroprene ...................................................................................................................................................................
cobalt .............................................................................................................................................................................
copper ...........................................................................................................................................................................
cryptosporidium .............................................................................................................................................................
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7349–92–1
91–57–6
Assessments in Progress
Substance name
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106–93–4
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75–07–0
107–02–8
79–06–1
107–13–1
116–06–3/1646–87–3
1646–88–4
7440–38–2
1332–21–4
71–43–2
50–32–8
7440–41–7
108–86–1
75–27–4
75–25–2
7440–43–9
56–23–5
75–00–3
67–66–3
126–99–8
7440–48–4
7440–50–8
[n.a.]
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Substance name
CAS No.
dibromochloromethane .................................................................................................................................................
dibutyl phthalate (chronic; less-than-lifetime** exposures) ...........................................................................................
1,2-dichlorobenzene ......................................................................................................................................................
1,3-dichlorobenzene ......................................................................................................................................................
1,4-dichlorobenzene ......................................................................................................................................................
1,2-dichloroethylene ......................................................................................................................................................
di(2-ethylhexyl)adipate (DEHA) ....................................................................................................................................
di(2-ethylhexyl)phthalate ...............................................................................................................................................
1,4-dioxane ...................................................................................................................................................................
ethanol ..........................................................................................................................................................................
ethyl tertiary butyl ether ................................................................................................................................................
ethylbenzene .................................................................................................................................................................
ethylene dichloride ........................................................................................................................................................
ethylene glycol monobutyl ether (cancer effects) .........................................................................................................
ethylene oxide (cancer effects; noncancer acute** exp.) .............................................................................................
formaldehyde* ...............................................................................................................................................................
hexachlorobutadiene .....................................................................................................................................................
hexachloro- cyclopentadiene** .....................................................................................................................................
hexahydro-1,3,5- trinitro-triazine (RDX)* ......................................................................................................................
n-hexane .......................................................................................................................................................................
hydrogen cyanide ..........................................................................................................................................................
hydrogen sulfide** .........................................................................................................................................................
isopropanol ....................................................................................................................................................................
kepone ..........................................................................................................................................................................
methanol .......................................................................................................................................................................
methyl tert-butyl ether (MTBE) .....................................................................................................................................
methylene chloride ........................................................................................................................................................
mirex .............................................................................................................................................................................
naphthalene (cancer effects, inhalation route) .............................................................................................................
nickel (soluble salts) .....................................................................................................................................................
nitrobenzene .................................................................................................................................................................
PAH mixtures ................................................................................................................................................................
pentachlorophenol .........................................................................................................................................................
perfluorooctanoic acid—ammonium salt (PFOA) .........................................................................................................
perfluorooctane sulfonate—potassium salt (PFOS) .....................................................................................................
phosgene (chronic; acute** exposure) .........................................................................................................................
polybrominated diphenyl ethers (tetra, penta, hexa, deca-PDEs) ...............................................................................
polychlorinated biphenyls (PCBs) (noncancer endpoints) ............................................................................................
propionaldehyde ............................................................................................................................................................
refractory ceramic fibers ...............................................................................................................................................
styrene ..........................................................................................................................................................................
2,3,7,8-TCDD (dioxin)* ..................................................................................................................................................
tetrachloroethylene (perchloroethylene) .......................................................................................................................
tetrahydrofuran ..............................................................................................................................................................
thallium ..........................................................................................................................................................................
toluene ..........................................................................................................................................................................
trichloroacetic acid ........................................................................................................................................................
1,1,1-trichloroethane (chronic; less-than-lifetime** exp.) ..............................................................................................
trichloroethylene* ..........................................................................................................................................................
1,2,3-trichloropropane ...................................................................................................................................................
2,2,4-trimethylpentane ..................................................................................................................................................
uranium compounds .....................................................................................................................................................
vinyl acetate ..................................................................................................................................................................
zinc and compounds .....................................................................................................................................................
IRIS summaries and support
documents for all substances listed as
on-going assessments in 2005 will be
provided on the IRIS Web site at
https://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.
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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
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124–48–1
84–74–2
95–50–1
541–73–1
106–46–7
540–59–0
103–23–1
117–81–7
123–91–1
64–17–5
637–92–3
100–41–4
107–06–2
111–76–2
75–21–8
50–00–0
87–68–3
77–47–4
121–82–4
110–54–3
74–90–8
7783–06–4
67–63–0
143–50–0
67–56–1
1634–04–4
75–09–2 (dichloromethane)
2385–85–5
91–20–3
[n.a.—various]
98–95–3
[n.a.—various]
87–86–5
3825–26–1
2795–39–3
75–44–5
[n.a.—various]
1336–36–3
123–38–6
[n.a.]
100–42–5
1746–01–6
127–18–4
109–99–9
7440–28–0
108–88–3
76–03–9
71–55–6
79–01–6
96–18–4
540–84–1
[n.a.—various]
108–05–4
7440–66–6
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.
10619
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.
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
Substance name
CAS No.
Reason for selection
butyl benzyl phthalate ..............................
85–68–7 .................
cerium ......................................................
1306–38–3 .............
hexachloroethane ....................................
67–72–1 .................
2-hexanone ..............................................
591–78–6 ...............
naphthalene (non-cancer) .......................
91–20–3 .................
platinum ...................................................
7440–06–4 .............
1,1,2,2-tetrachloroethane .........................
79–34–5 .................
CERCLA site cleanup and RCRA need. Newer scientific information is available to update older assessment.
CAA need. Scientific information is available to develop a first IRIS assessment.
CERCLA site cleanup need. Newer scientific information is available to update
older assessment.
CERCLA site cleanup and RCRA need. Scientific information is available to
develop a first IRIS assessment.
CERCLA site cleanup need. Newer scientific information is available to update
older assessment.
CAA need. Scientific information is available to develop a first IRIS assessment.
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-ofevidence 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. Screeninglevel 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
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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 indepth 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 (https://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
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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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Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices
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 https://
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
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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.
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[RCRA–2005–0001; FRL–7880–2]
Modification of the RCRA, Superfund &
EPCRA Call Center; Public Information
Distribution
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: The Office of Solid Waste and
Emergency Response (OSWER) is today
announcing significant changes to the
operation of the RCRA, Superfund &
EPCRA Call Center (Call Center). The
Call Center will terminate support of the
Resource Conservation and Recovery
Act (RCRA) and Underground Storage
Tanks (UST) programs at close of
business on Thursday, March 31, 2005.
Individuals seeking information on the
RCRA and UST programs after that date
will be directed to EPA’s Headquarters’
and Regional Offices’ Web sites for these
programs, and other sources as
described in the SUPPLEMENTARY
INFORMATION section.
The Call Center will continue as
before to respond to public inquiries
about the Comprehensive
Environmental Response,
Compensation, and Liability Act
(CERCLA, or Superfund), including the
Small Business Liability Relief and
Brownfields Revitalization Act
(SBLRBRA, or Brownfields); the
Emergency Planning and Community
Right-to-Know Act (EPCRA), including
the Toxic Release Inventory (TRI)
program; the Superfund Amendments
Reauthorization Act (SARA) Title III;
the Clean Air Act (CAA) Section 112(r);
and the Oil Pollution Control Act
(OPA). Call Center access will remain
unchanged for these programs.
DATES: The Call Center will terminate
all support of the RCRA and OUST
programs at close of business on
Thursday, March 31, 2005.
ADDRESSES: EPA has established a
docket for this notice under Docket ID
RCRA–2005–0001. Written
E:\FR\FM\04MRN1.SGM
04MRN1
Agencies
[Federal Register Volume 70, Number 42 (Friday, March 4, 2005)]
[Notices]
[Pages 10616-10620]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4275]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.epa.gov/edocket
(EPA's preferred method); by e-mail to oei.docket@epa.gov; 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:
mills.amy@epa.gov.
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 hotline.iris@epa.gov.
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 (https://
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
https://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
(https://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
https://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]
BILLING CODE 6560-50-P