[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 [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. 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 [email protected].

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:

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

[[Page 76]]

                                                                        
Vinyl chloride.............................................      75-01-4
------------------------------------------------------------------------

    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:

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

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.

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

    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.[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. 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]
BILLING CODE 6560-50-P