[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.
------------------------------------------------------------------------
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
------------------------------------------------------------------------
 = 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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