[Federal Register Volume 67, Number 6 (Wednesday, January 9, 2002)]
[Notices]
[Pages 1212-1215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-511]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-7127-2]
Integrated Risk Information System (IRIS); Announcement of 2002
Program; Request for Information
AGENCY: Environmental Protection Agency.
ACTION: Notice; announcement of IRIS 2002 program and request for
scientific information on health effects that may result from exposure
to chemical substances.
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SUMMARY: IRIS is an Environmental Protection Agency (EPA) data base
that contains EPA scientific consensus positions on human health
effects that may result from chronic exposure to chemical substances in
the environment. On February 22, 2001, EPA announced the 2001 IRIS
agenda and solicited scientific information from the public for
consideration in assessing health effects from specific chemical
substances (66 FR 11165). Most of the health assessments listed in the
notice are in progress or near completion. Today, EPA is adding some
additional health assessments to the IRIS agenda. This notice describes
the Agency's plans, and solicits scientific data and evaluations for
consideration in EPA's new assessments. Additional new assessments may
be announced in the Federal Register later this year.
DATES: Please submit any response to this notice in the form of an
initial ``submission inventory'' in accordance with the instructions in
this notice by March 11, 2002.
ADDRESSES: A ``submission inventory'' should be sent to the IRIS
Submission Desk in accordance with the instructions provided under
``Submission of Information'' in this notice.
FOR FURTHER INFORMATION: For information on the IRIS program, contact
Amy Mills, National Center for Environmental Assessment, (mail code
8601D), U.S. Environmental Protection Agency, Washington, DC 20460, or
call (202) 564-3204, or send electronic mail inquiries to
[email protected]. For general questions about access to IRIS, or the
content of IRIS, please call the IRIS Hotline at (301) 345-2870 or send
electronic mail inquiries to [email protected].
SUPPLEMENTARY INFORMATION:
Background
IRIS is an EPA data base containing Agency consensus scientific
positions on potential adverse human health effects that may result
from chronic (or lifetime) exposure to chemical substances found in the
environment. IRIS currently provides health effects information on over
500 specific chemical substances.
IRIS contains 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. IRIS information includes the reference dose for
noncancer health effects resulting from oral exposure, the reference
concentration for non-cancer health effects resulting from inhalation
exposure, and the carcinogen assessment for both oral and inhalation
exposure. Combined with specific situational exposure assessment
information, the summary health hazard information in IRIS may be used
as a source in evaluating potential public health risks from
environmental contaminants.
[[Page 1213]]
The IRIS Program
EPA's process for developing IRIS consists of: (1) An annual
Federal Register announcement of EPA's IRIS agenda and call for
scientific information from the public on the selected chemical
substances, (2) a search of the current literature, (3) development of
health assessments and draft IRIS summaries, (4) peer review within
EPA, (5) peer review outside EPA, (6) EPA consensus review and
management approval, (7) preparation of final IRIS summaries and
supporting documents, and (8) entry of summaries and supporting
documents into the IRIS data base.
This notice provides: (1) A list of the IRIS assessments completed
in FY 2001 and early FY 2002, (2) a list of the IRIS assessments in
progress that the Agency expects to complete in FY 2002 or FY 2003, (3)
a list of the IRIS assessments in progress that the Agency expects to
complete in FY 2004 or FY 2005, (4) a list of the IRIS assessments
announced in the previous IRIS agenda (66 FR 11165) that have been
discontinued, (5) information about EPA's IRIS ``needs assessment''
report underway, (6) a list of the new assessments beginning in FY
2002, and (7) instructions to the public for submitting scientific
information to EPA pertinent to the development of IRIS assessments.
Assessments Completed in FY 2001 and Early FY 2002
The following assessments were completed and entered into IRIS in
FY 2001 and early FY 2002. These assessments were listed in the Federal
Register of February 22, 2001. All health endpoints, cancer and
noncancer, were assessed unless otherwise noted. Where information was
available, both qualitative and quantitative assessments were
developed.
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Name CAS No.
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Bromate.................................................... 7758-01-2
Chlorine dioxide........................................... 10049-04-4
Chlorite (sodium salts).................................... 7758-19-2
Chloroform (oral route).................................... 67-66-3
Hexachlorocyclopentadiene.................................. 77-47-4
Methylmercury (noncancer endpoints)........................ 22967-92-6
Methyl chloride............................................ 74-87-3
Quinoline.................................................. 91-22-5
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Assessments in Progress--Completion Planned for FY 2002 or FY 2003
The following assessments are underway or generally complete, and
are planned for entry into IRIS in FY 2002 or FY 2003. These
assessments were announced in the February 22, 2001, Federal Register.
All health endpoints, 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. Pesticides denoted with an asterisk (*) will have only oral
reference dose and carcinogenicity endpoints assessed.
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Name CAS No.
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Acetaldehyde............................................... 75-07-0
Acetone.................................................... 67-64-1
Acrolein................................................... 107-02-8
Alachlor*.................................................. 15972-60-8
Ammonium perchlorate (and other perchlorate salts)......... 7790-98-9
Antimony and compounds..................................... 7440-36-0
Azinphos Methyl*........................................... 86-50-0
Benzene (noncancer endpoints).............................. 71-43-2
Benzo(a)pyrene............................................. 50-32-8
Bromoxynil*................................................ 1689-84-5
Boron...................................................... 7440-42-8
1,3-Butadiene.............................................. 106-99-0
Cadmium.................................................... 7440-43-9
Carbon tetrachloride....................................... 56-23-5
Chloroethane............................................... 75-00-3
Chloroform (inhalation route).............................. 67-66-3
Chloroprene................................................ 126-99-8
Chlorothalonil*............................................ 1897-45-6
Chlorpyrifos*.............................................. 2921-88-2
Copper..................................................... 7440-50-8
Cyclohexane................................................ 110-82-7
Diazinon*.................................................. 333-41-5
Dichloroacetic acid........................................ 79-43-6
1,2-Dichlorobenzene........................................ 95-50-1
1,3-Dichlorobenzene........................................ 541-73-1
1,4-Dichlorobenzene........................................ 106-46-7
1,1-Dichloroethylene....................................... 75-35-4
Diesel exhaust............................................. [N.A.]
Di(2-ethylhexyl)phthalate.................................. 117-81-7
Diflubenzuron.............................................. 35367-38-5
Ethanol.................................................... 64-17-5
Ethion*.................................................... 563-12-2
Ethylbenzene............................................... 100-41-4
Ethylene dibromide......................................... 106-93-4
Ethylene dichloride........................................ 107-06-2
Ethylene oxide............................................. 75-21-8
Formaldehyde............................................... 50-00-0
Glyphosate*................................................ 1071-83-6
Hexachlorobutadiene........................................ 87-68-3
Hydrogen sulfide........................................... 7783-06-4
Isopropanol................................................ 67-63-0
Metolachlor*............................................... 51218-45-2
Methidathion*.............................................. 950-37-8
Methyl isobutyl ketone (MIBK).............................. 108-10-1
Methyl parathion*.......................................... 298-00-0
Methyl tert-butyl ether (MTBE)............................. 1634-04-4
Mirex...................................................... 2385-85-5
Nickel (soluble salts)..................................... [N.A.]
Nitrobenzene............................................... 98-95-3
Pendimethalin*............................................. 40487-42-1
Phenol..................................................... 108-95-2
Pebulate*.................................................. 1114-71-2
Pentachlorophenol.......................................... 87-86-5
Phosgene................................................... 75-44-5
Polychlorinated biphenyls (PCBs-noncancer endpoints)....... 1336-36-3
Refractory ceramic fibers.................................. [N.A.]
Styrene.................................................... 100-42-5
2,3,7,8-TCDD (dioxin)...................................... 1746-01-6
Tetrachloroethylene (perchloroethylene).................... 127-18-4
Tetrahydrofuran............................................ 109-99-9
Toluene.................................................... 108-88-3
Triallate*................................................. 2303-17-5
Trichlopyr*................................................ 55335-06-3
Trichloroethylene.......................................... 79-01-6
Uranium (natural).......................................... 7440-61-1
Vinyl acetate.............................................. 108-05-4
Xylenes.................................................... 1330-20-7
Zinc and compounds......................................... 7440-66-6
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Assessments in Progress--Completion Planned for FY 2004 or FY 2005
The following assessments in progress have been delayed and are now
expected for completion in FY 2004 or FY 2005:
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Name CAS No.
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Acrylamide................................................. 79-06-1
Asbestos................................................... 1332-21-4
Hexahydro-1,3,5-trinitro-triazine..........................
(RDX).................................................... 121-82-4
Methanol................................................... 67-56-1
Silica (crystalline)....................................... 14808-60-7
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IRIS summaries and support documents for all substances listed
above will be provided on the IRIS web site at 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 documents can be found during their peer review periods via the
``What's New'' page of the IRIS web site. Interested parties should
check the ``What's New'' page frequently for the availability of these
drafts.
Assessments Discontinued
The following assessments have been removed from the IRIS agenda
for FY 2002, but may be reconsidered at a later date:
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Name CAS No.
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Arsenic, inorganic......................................... 7440-38-2
Bisphenol-A................................................ 80-05-7
Hexachlorobenzene.......................................... 118-74-1
Methylene chloride......................................... 75-09-2
Toxaphene.................................................. 8001-35-2
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IRIS ``Needs Assessment''
On July 20, 2001, EPA published a Federal Register notice (66 FR
37958) requesting public input to compile a ``needs assessment'' for
planning the IRIS program. This notice requested that the public
identify those chemical substances for which assessments either need to
be added to IRIS or updated. The responses were considered along with
EPA program priorities in the development of new starts for the FY 2002
agenda below. The notice also requested input on whether other types of
evaluations are needed on IRIS, such
[[Page 1214]]
as toxicological evaluations for health effects associated with less-
than-lifetime (i.e., acute or subchronic) exposure durations. The
notice also requested input on what priority any new type of evaluation
should have compared to evaluation of health effects associated with
chronic exposures.
Further, the notice asked whether or how EPA should work with
external parties, such as other government agencies, industries, or
other organizations to develop health assessments that may be used as
supporting documents for IRIS. A pilot effort to provide dialogue and
feedback to external parties developing health assessments for IRIS was
described in the February 22, 2001 notice, and preceding IRIS Federal
Register notices. Of the six pilot efforts discussed, four are still in
progress and two are discontinued. In FY 2002, EPA will continue to
evaluate its experience with the current efforts to determine process
efficiency and quality of the documents produced.
A separate ``IRIS Needs Assessment'' report will be made available
on the IRIS web site when it is completed.
Information Requested on New Assessments for FY 2002
EPA will continue building and updating the IRIS data base. 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, EPA developed a list of priority substances for attention
beginning in FY 2002. The following substances are priorities for IRIS
due to one or more reasons: (1) Agency statutory, regulatory, or
program implementation needs; (2) new scientific information or
methodology is available that might significantly change current IRIS
information; (3) interest to other levels of government or the public,
including interest expressed via responses to 66 FR 37958; (4) most of
the scientific assessment work has been completed while meeting other
Agency requirements, and only a modest additional effort will be needed
to complete the review and documentation for IRIS.
The following IRIS health assessments have recently begun or will
be started in FY 2002, with completion expected in FY 2003 or FY 2004,
unless otherwise noted. It is for these substances that the Agency is
primarily requesting information from the public for consideration in
the assessments. Unless otherwise noted, noncancer and cancer endpoints
will be assessed for each substance. Pesticides denoted with an
asterisk (*) will have only oral reference dose and carcinogenicity
endpoints assessed. Substances denoted with a double asterisk (**) will
be evaluated for effects from acute and subchronic exposure, in
addition to chronic exposure. These substances constitute a pilot test
to evaluate the application of methods, procedures, and resource needs
for adding less-than-lifetime information to IRIS. For all endpoints
assessed, both qualitative and quantitative assessments are being
developed where information is available.
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Name CAS No.
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Atrazine*.................................................. 1912-24-9
Captan*.................................................... 133-06-2
Di(2-ethylhexyl)adipate (DEHA)............................. 103-23-1
Dibutyl phthalate.......................................... 84-74-2
Ethalfluralin*............................................. 55283-68-6
gamma-Hexachlorocyclohexane (Lindane)*..................... 58-89-9
Hydrogen cyanide .................................. 74-90-8
Methyl ethyl ketone........................................ 78-93-3
2-Methylnaphthalene........................................ 91-57-6
Methomyl*.................................................. 16752-77-5
Naphthalene (cancer; inh. route)........................... 91-20-3
PAH mixtures............................................... N.A.
Perfluorooctanoic acid--ammonium salt**.................... 3825-26-1
Perfluorooctane sulfonate--potassium salt**................ 2795-39-3
Propachlor*................................................ 1918-16-7
Thallium........................................... 7440-28-0
1,1,1-Trichloroethane**.................................... 71-55-6
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= completion expected FY 2004/FY 2005.
Submission of Information
As in previous Federal Register notices announcing the annual IRIS
agenda, EPA is soliciting public involvement in new assessments
starting in FY 2002. 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 greatly appreciate receiving scientific
information from the public during the information gathering stage for
the list of ``new assessments'' listed above. Interested persons should
provide scientific analyses, studies, and other pertinent scientific
information. Also note that if you have submitted certain information
previously, then there is no need to resubmit that information. While
EPA is primarily soliciting information on new assessments announced in
this notice, the public may submit information on any chemical
substance at any time.
Procedures for Submission
Similar to the process described in the February 22, 2001, Federal
Register, submissions will be handled in a three-step process:
1. Submission Inventory: First, you should simply provide a list
within 60 days of this notice briefly identifying all the information
(studies, reports, articles, etc.) you wish to submit. The list should
specify by name and CASRN (Chemical Abstract Service Registry Number)
the chemical substance(s) to which the information pertains, state the
type of assessment that is being addressed (e.g., carcinogenicity), and
describe briefly the information to be submitted for consideration.
Where possible, documents should be listed in scientific citation
format, that is, author(s), title, journal, and date. Your cover letter
should state that the correspondence is an IRIS submission, describe in
general terms the purpose of the submission, and include names,
addresses, and telephone numbers of person(s) to contact for additional
information. Mail two copies of the submission inventory to the IRIS
Submission Desk, c/o ASRC, 6301 Ivy Lane, Suite 300, Greenbelt, MD
20770. Note that this is a new address for the Submission Desk.
Alternatively, you may submit the submission inventory and cover
letter electronically to [email protected]. Electronic information must
be submitted in WordPerfect format or as an ASCII file. Information
also will be accepted on 3.5'' floppy disks. All information in
electronic form must be identified as an IRIS submission.
2. EPA Replies to Submission Inventory: In the second step, EPA
will compare the submission inventory to existing files and identify
the information that should be submitted. This step will help prevent
an influx of duplicative information. You will receive notification of
whether full submission of the information is requested.
3. Full Submission of Selected Material: In the third step, you
should send in the information indicated by EPA within 30 days of EPA's
reply. Prompt response to EPA will ensure that your material can be
considered in the assessment in a timely fashion. Submissions should
include a cover letter addressing all of the points in Item 1 above. In
addition, when you submit results of new health effects studies
concerning existing substances on IRIS, you should include a specific
explanation of how and why the study results could change the
information in IRIS.
[[Page 1215]]
Please send two copies, at least one of which should be unbound, to
the IRIS Submission Desk, as described in Item 1. The IRIS Submission
Desk will acknowledge receipt of your information.
Confidential Business Information (CBI) should not be submitted to
the IRIS Submission Desk. CBI must be submitted to the appropriate EPA
Office via established procedures for submission of CBI (see 40 CFR,
Part 2, Subpart B). If you believe that a CBI submission contains
information with implications for IRIS, please note that in the cover
letter accompanying the submission to the appropriate office.
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).
Dated: January 2, 2002.
Art Payne,
Acting Deputy Director, National Center for Environmental Assessment.
[FR Doc. 02-511 Filed 1-8-02; 8:45 am]
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