[Federal Register Volume 63, Number 237 (Thursday, December 10, 1998)]
[Notices]
[Pages 68285-68287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32892]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-6200-3]
Integrated Risk Information System (IRIS); Announcement of 1999
Program; Request for Information
AGENCY: Environmental Protection Agency.
ACTION: Notice; Announcement of IRIS 1999 Program and request for
scientific information on chronic health effects of chemical
substances.
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SUMMARY: The Integrated Risk Information System (IRIS) is an EPA data
base that contains EPA scientific consensus positions on potential
human health effects from environmental contaminants. On January 2,
1998 EPA announced the 1998 IRIS agenda and solicited scientific
information from the public for consideration in assessing the chronic
health effects of a list of chemical substances (63 FR 75). Most of the
assessments listed are complete or near completion, and EPA is
preparing a new set of chemical health assessments for IRIS. This
Notice describes the Agency's plans, and solicits scientific data and
evaluations for consideration in EPA's new assessments.
DATES: Please submit information in response to this Notice by February
12, 1999.
[[Page 68286]]
ADDRESSES: Please send relevant scientific information 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, 401 M St. SW, Washington,
DC 20460, or call (202) 564-3204, or send electronic mail inquiries to
mills.amy@epa.gov. For general questions about access to IRIS, the
content of IRIS, or how to submit information in response to this
Notice, please call the Risk Information Hotline at (513) 569-7254.
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 environmental contaminants. 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
non-cancer 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.
The IRIS Program
EPA completed the IRIS Pilot Program, which focused on improving
the scientific consensus and review process that precedes IRIS data
base entries. A set of chemical assessments were developed (or updated,
for existing entries) for IRIS utilizing the pilot process. This
process has been adopted for the post-Pilot program and 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.
Assessments Completed in FY 1998
The following assessments were completed and entered into IRIS in
FY 1998 and early FY 1999. These assessments were announced in the
Federal Register notice of January 2, 1998. All health endpoints,
cancer and non-cancer, were assessed unless otherwise noted. Where
information was available, oral reference doses, inhalation reference
concentrations, and cancer unit risks and slope factors were developed.
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Name CAS No.
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Arsenic [text added in carcinogenicity 7440-38-2
section].
Barium................................... 7440-39-3
Bentazon................................. 25057-89-0
Benzene [inhalation cancer assessment]... 71-43-2
Beryllium................................ 7440-41-7
Chlordane................................ 12789-03-6
Chromium (III ).......................... 16065-83-1
Chromium (VI)............................ 18540-29-9
Methyl methacrylate...................... 80-62-6
Methylene diphenyl diisocyanate.......... 101-68-8
Naphthalene.............................. 91-20-3
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Assessments in Progress--Completion Planned for FY 1999 or FY 2000
The following assessments are underway or generally complete, and
are planned for entry into IRIS in FY 1999 or FY 2000. These
assessments were announced in the January 2, 1998 Federal Register
notice. All health endpoints, cancer and non-cancer, are being assessed
unless otherwise noted. Where information is available, oral reference
doses, inhalation reference concentrations, cancer unit risks and slope
factors are being developed.
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Name CAS No.
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Acetonitrile............................. 75-05-8
Benzene [non-cancer; oral cancer 71-43-2
endpoints].
Boron.................................... 7440-42-8
Bromate.................................. 7758-01-2
1,3-Butadiene............................ 106-99-0
Cadmium.................................. 7440-43-9
Chloral hydrate.......................... 75-87-6
Chloroethane............................. 75-00-3
Chloroform............................... 67-66-3
Dichloroacetic acid...................... 79-43-6
1,3-Dichloropropene...................... 542-75-6
Diesel emissions......................... [N.A.]
Ethylene glycol butyl ether.............. 111-76-2
Formaldehyde............................. 50-00-0
Nitrobenzene............................. 98-95-3
Pentachlorophenol........................ 87-86-5
Polychlorinated biphenyls (PCBs)-- 1336-36-3
[noncancer endpoints].
Styrene.................................. 100-42-5
Tetrachloroethylene [``perc'']........... 127-18-4
Tetrahydrofuran.......................... 109-99-9
Toxaphene................................ 8001-35-2
Trichloroethylene........................ 79-01-6
Vinyl acetate............................ 108-05-4
Vinyl chloride........................... 75-01-4
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The reassessment of Lindane [CAS No. 58-89-9 ] announced in the
January 2, 1998 Federal Register notice has been postponed to begin in
FY 2000 pending results from an ongoing cancer study.
The IRIS summaries and support documents for the substances listed
above will be provided on the IRIS web site at www.epa.gov/iris. This
publicly-available web site is EPA's primary location for IRIS
documents.
Information Requested on New Assessments for FY 1999
EPA will continue building and updating the IRIS data base. The
Agency recognizes that many 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 1999. The following list of substances are priorities for IRIS due
to one or more of the following reasons: (1) Agency statutory,
regulatory, or program implementation need; (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, (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 1999, with completion expected between FY 2000 and FY
2001. It is for these substances that the Agency is primarily
requesting information from the public for consideration in the
assessment. Unless otherwise noted, noncancer and cancer endpoints will
be assessed for each substance. Where information is available, oral
reference doses, inhalation reference concentrations, and cancer unit
risks and slope factors will be developed.
[[Page 68287]]
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Name CAS No.
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Acetaldehyde............................. 75-07-0
Acetone.................................. 67-64-1
Ammonium perchlorate [and associated 7790-98-9
salts].
Benzo[a]pyrene........................... 50-32-8
Chlorine dioxide......................... 10049-04-4
Chlorite (sodium salts).................. 7758-19-2
Chloroprene.............................. 126-99-8
Copper................................... 7440-50-8
Cyclohexane.............................. 110-82-7
Di(2-ethylhexyl)phthalate................ 117-81-7
Diflubenzuron............................ 35367-38-5
Ethylbenzene............................. 100-41-4
Ethylene oxide........................... 75-21-8
Hexachlorocyclopentadiene................ 77-47-4
Isopropanol.............................. 67-63-0
Methyl chloride.......................... 74-87-3
Methyl isobutyl ketone (MIBK)............ 108-10-1
Methyl tert-butyl ether (MTBE)........... 1634-04-4
Nickel (various)......................... 7440-02-0
Pendimethalin............................ 40487-42-1
Phenol................................... 108-95-2
Quinoline................................ 91-22-5
Silica (quartz).......................... 14808-60-7
Trichlopyr............................... 55335-06-3
Uranium (natural)........................ 7440-61-1
Xylenes.................................. 1330-20-7
Zinc and compounds....................... 7440-66-6
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In addition to Benzo[a]pyrene, EPA will also be initiating in FY
1999 a literature review on health effects of other polynuclear
aromatic hydrocarbons (PAHs). EPA welcomes scientific information from
the public on health effects of PAHs. Additional health assessments on
this class of chemicals will commence in FY 2000.
Follow-up annual Federal Register notices will address new starts
for subsequent fiscal years. In the future, these notices will include
chemical substances selected for assessment or reassessment under EPA's
new guidelines for carcinogen risk assessment that are also planned for
inclusion in IRIS (64 FR 32799, June 25, 1996).
Submission of Information
The IRIS program is providing an opportunity for public involvement
on new assessments starting in FY 1999. While EPA conducts a thorough
literature search for each chemical substance, there may be other
articles or unpublished studies we are not aware of. 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 comments, analyses,
studies, and other pertinent scientific information. The most useful
documents for EPA are unpublished studies or other primary technical
sources that we may not otherwise obtain through open literature
searches. Also note that if you have submitted certain information
previously then there is no need to resubmit that information.
Information from the public is being solicited for 60 days via this
notice.
Similar to the process described in the January 2, 1998 Federal
Register notice, submissions will be handled in a three-step process:
1. First, you should simply provide a list (submission inventory),
briefly identifying all the information you wish to submit to the IRIS
Submission Desk. The list should specify by name and CAS (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
being 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 persons to contact for additional information on the
submission. Mail three copies of the submittal to the IRIS Submission
Desk, NCEA (MS-105), U.S. Environmental Protection Agency, 26 Martin
Luther King Drive, Cincinnati, OH 45268.
Alternatively, you may submit the submission inventory and cover
letter electronically to IRIS.comments@epa.gov. Electronic information
must be submitted in WordPerfect or as an ASCII file. Information will
also be accepted on 3.5'' floppy disks. All information in electronic
form must be identified as an IRIS Submission.
2. 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 requesting full submission of the selected
material.
3. In the third step, you should send in the information requested
by EPA within 30 days to ensure that EPA can consider it in the
assessment. Submittals 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.
Please send three copies, at least one of which should be unbound,
to the IRIS Submission Desk, NCEA (MS-105), U.S. Environmental
Protection Agency, 26 Martin Luther King Drive, Cincinnati, OH 45268.
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 Manager (Addressees).
Dated: December 3, 1998.
William H. Farland,
Director, National Center for Environmental Assessment.
[FR Doc. 98-32892 Filed 12-9-98; 8:45 am]
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