[Federal Register Volume 63, Number 1 (Friday, January 2, 1998)]
[Notices]
[Pages 75-77]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-34198]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-5945-3]
Integrated Risk Information System (IRIS); Announcement of 1998
Program; Request for Information
AGENCY: U.S. Environmental Protection Agency.
ACTION: Notice; Announcement of IRIS 1998 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 a data base
of the United States Environmental Protection Agency (EPA) that
contains EPA scientific consensus positions on potential human health
effects from environmental contaminants. On April 2, 1996 EPA announced
the IRIS Pilot Program and solicited scientific information from the
public for consideration in assessing the chronic health effects of
eleven chemical substances. (See FR Vol. 61 No. 64 p. 14570.) The Pilot
program is near completion, and the Agency is preparing a new set of
chemical health assessments for IRIS. The purpose of this notice is to
communicate to the public the Agency's plans, and solicit scientific
data and evaluations for consideration in EPA's new assessments.
DATES: Please submit information in response to this notice by March 3,
1998.
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 CONTACT: For information on the IRIS program,
contact Amy Mills, National Center for Environmental Assessment (mail
code 8623), U.S. Environmental Protection Agency, 401 M St. SW,
Washington, DC 20460, or call (202) 260-0569, or send electronic mail
inquiries to mills.amy@epamail.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. For scientific issues contact Terry Harvey, National
Center for Environmental Assessment, 26 Martin Luther King Drive,
Cincinnati, OH 45268, or call (513) 569-7531, or send electronic mail
inquiries to harvey.terry@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
Background
The Integrated Risk Information System (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 Pilot Program
As a consequence of analyzing the IRIS program and considering
suggestions received about IRIS through 1995, the Agency tested some
improvements through a Pilot Program. The Pilot focused on improving
the scientific consensus and review process that precedes IRIS data
base entries. EPA developed (or updated, for existing entries) non-
cancer and cancer information for eleven Pilot substances. The Pilot
process consisted of, (1) a call for technical information on the
eleven substances from the public via a FR Notice, April 2, 1996, (2) a
search of the current literature, (3) development of health assessments
and draft IRIS summaries, (3) internal peer review (i.e., within EPA),
(4) external peer review (i.e., outside EPA), (5) Agency consensus
review and management approval within EPA, (6) preparation of final
IRIS summaries and supporting documents, and (7) entry of summaries
into the IRIS data base. The last stage is currently underway for most
of the Pilot substances.
EPA's evaluation of the Pilot provided the basis for designing the
operation of the future IRIS program. For example, the Agency
standardized (1) the solicitation of scientific information from the
public via a FR notice, (2) the use of the ``Toxicological Review'' as
a preferred support document for IRIS entries which combines cancer and
noncancer assessments, and (3) the use of rigorous external peer review
procedures for IRIS summaries and Toxicological Reviews. The final
Agency consensus review process, while still being tested, is replacing
the former ``CRAVE'' and ``RfD/RfC Work Groups''.
The following substances were reviewed under the Pilot Program:
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Name CAS. No.
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Arsenic.................................................... 7440-38-2
Bentazon................................................... 25057-89-0
Beryllium.................................................. 7440-41-7
Chlordane.................................................. 12789-03-6
Chromium:
Cr (III)................................................. 16065-83-1
Cr (VI).................................................. 18540-29-9
Total Cr................................................. 7440-47-3
Cumene..................................................... 98-82-8
Methyl methacrylate........................................ 80-62-6
Diphenylmethane diisocyanate............................... 101-68-8
Naphthalene................................................ 91-20-3
Tributyltin oxide.......................................... 56-35-9
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Vinyl chloride............................................. 75-01-4
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A cancer assessment for polychlorinated biphenyls (PCBs) and an
oral noncancer assessment for trinitrobenzene were also added to IRIS
during the Pilot period. The IRIS summaries and support documents for
the substances listed above are now provided on the IRIS web site at
www.epa.gov/iris, or will be provided shortly. This publicly-available
web site will be the primary location for all new IRIS summaries and
Toxicological Reviews.
New Starts and Completions for FY 1998
EPA will continue building and updating the IRIS data base
utilizing the experiences gained from the IRIS Pilot. 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, a
list of priority substances was developed internally by EPA for
attention in FY 1998. The following lists 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. Unless otherwise noted,
noncancer and cancer endpoints will be assessed for each substance.
Assessments in Progress--Completion Planned for FY 1998
In addition to completing the remaining Pilot assessments, the
following assessments are underway or generally complete, and are
planned for update on IRIS in FY 1998:
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Name CAS No.
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Acetonitrile............................................... 75-05-8
Barium..................................................... 7440-39-3
Benzene.................................................... 71-43-2
1,3-Butadiene.............................................. 106-99-0
Cadmium.................................................... 7440-43-9
Chloroethane............................................... 75-00-3
Diesel emissions........................................... [N.A.]
Ethylene glycol butyl ether................................ 111-76-2
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Information requested on new assessments
The following IRIS health assessments have recently begun or will
be started in FY 1998, with completion expected between late FY 1998
and early FY 2000. It is for these substances that the Agency is
primarily requesting information from the public for consideration in
the assessment.
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Name CAS No.
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Boron...................................................... 7440-42-8
Bromate.................................................... 7758-01-2
Chloral hydrate............................................ 75-87-6
Chloroform................................................. 67-66-3
Dichloroacetic acid........................................ 79-43-6
1,3-Dichloropropene........................................ 542-75-6
Formaldehyde............................................... 50-00-0
Lindane.................................................... 58-89-9
Nitrobenzene............................................... 98-95-3
Pentachlorophenol.......................................... 87-86-5
Polychlorinated biphenyls (PCBs)--[noncancer endpoints].... 1336-36-3
Styrene.................................................... 100-42-5
Tetrachloroethylene........................................ 127-18-4
Tetrahydrofuran............................................ 109-99-9
Toxaphene.................................................. 8001-35-2
Trichloroethylene.......................................... 79-01-6
Vinyl acetate.............................................. 108-05-4
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Check the IRIS web site at www.epa.gov/iris for any additions to
the above list during the course of FY 1998. Follow-up 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 (See FR
Vol. 61 no. 64 p. 32799, June 25, 1996).
Submission of Information
The IRIS program is providing an opportunity for public involvement
on new assessments starting in FY 1998. While the Agency conducts a
thorough literature search for each chemical substance, there may be
other articles or unpublished studies we are not aware of. The Agency
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 FR Notice for the IRIS
Pilot, submissions will be handled in a three-step process:
1. First, interested parties should simply provide a list
(submission inventory), briefly identifying all the information they
wish to submit to the IRIS Submission Desk. The list should specify by
name and CAS (Chemical Abstract 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. A 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. Three copies of the submittal should be
mailed to the IRIS Submission Desk, NCEA (MS-105), U.S. Environmental
Protection Agency, 26 Martin Luther King Drive, Cincinnati, OH 45268.
The submission inventory and cover letter may instead be submitted
electronically to IRIS.comments@epamail.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. The
submitter will receive notification requesting full submission of the
selected material.
3. In the third step, the submitter must send in the information
requested by EPA within 30 days to ensure its consideration in the
assessment. Submittals should include a cover letter addressing all of
the points in item 1 above. In addition, persons submitting results of
new health effects studies concerning existing substances on IRIS
should include a specific explanation of how and why the study results
could change the information in IRIS.
[[Page 77]]
Submitters are requested to send three copies, at least one of
which should be unbound. The submittal should be mailed to the IRIS
Submission Desk, NCEA (MS-105), U.S. Environmental Protection Agency,
26 Martin Luther King Drive, Cincinnati, OH 45268. Receipt of
information will be acknowledged by the IRIS Submission Desk.
Confidential Business Information (CBI) should not be submitted to
the IRIS Submission Desk. CBI must be submitted to the appropriate EPA
Office via approved Agency procedures for submission of CBI as codified
in the Code of Federal Regulations (40 CFR, Part 2, Subpart B). If a
submitter believes that a CBI submission contains information with
implications for IRIS, it should be noted in the cover letter
accompanying the submission to the appropriate office.
Submitters may also request to augment their submission with a
scientific briefing to EPA staff. Such requests should be made directly
to Amy Mills, acting IRIS Assessment Manager (see Addressees).
Dated: December 24, 1997.
William H. Farland,
Director, National Center for Environmental Assessment.
[FR Doc. 97-34198 Filed 12-31-97; 8:45 am]
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