[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 
[email protected]. 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.

------------------------------------------------------------------------
                   Name                               CAS No.
------------------------------------------------------------------------
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
------------------------------------------------------------------------

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.

------------------------------------------------------------------------
                   Name                               CAS No.
------------------------------------------------------------------------
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
------------------------------------------------------------------------

    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]]



------------------------------------------------------------------------
                   Name                               CAS No.
------------------------------------------------------------------------
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
------------------------------------------------------------------------

    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.[email protected]. 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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