[Federal Register Volume 66, Number 36 (Thursday, February 22, 2001)]
[Notices]
[Pages 11165-11167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-2175]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-6937-1]


Integrated Risk Information System (IRIS); Announcement of 2001 
Program; Request for Information

AGENCY: Environmental Protection Agency.

ACTION: Notice; announcement of IRIS 2001 program and request for 
scientific information on health effects that may result from chronic 
exposure to chemical substances.

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SUMMARY: The Integrated Risk Information System (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 
January 12, 2000, EPA announced the 2000 IRIS agenda and solicited 
scientific information from the public for consideration in assessing 
health effects from specific chemical substances (65 FR 1863). A 
supplementary notice issued May 17, 2000 (65 FR 31309) added two 
additional substances to the agenda. Most of the health assessments 
listed in the two notices 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.

DATES: Please submit information in response to this notice by April 
23, 2001.

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, 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 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 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 
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's process for developing IRIS consists of: (1) An annual 
Federal Register notice announcing 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 2000 and Early FY 2001

    The following assessments were completed and entered into IRIS in 
FY 2000 and early FY 2001. These assessments were listed in the Federal 
Register of January 12, 2000. All health endpoints, cancer and non-
cancer, were assessed unless otherwise noted. Where information was 
available, both qualitative and quantitative assessments were 
developed.

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                          Name                                CAS No.
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Benzene (oral carcinogenicity)..........................         71-43-2
Chloral hydrate.........................................         75-87-6
Chlorine dioxide........................................      10049-04-4
Chlorite (sodium salts).................................       7758-19-2
1,3-Dichloropropene.....................................        542-75-6
Ethylene glycol monobutyl ether.........................        111-76-2
Vinyl chloride..........................................         75-01-4
------------------------------------------------------------------------

Assessments in Progress--Completion Planned for FY 2001 or FY 2002

    The following assessments are underway or generally complete, and 
are planned for entry into IRIS in FY 2001 or FY 2002. These 
assessments were announced in the January 12, 2000, or May 17, 2000, 
Federal Registers. All health endpoints, cancer and non-cancer, are 
being assessed unless otherwise noted. Pesticides

[[Page 11166]]

denoted with an asterisk (*) will have only oral reference dose and 
carcinogenicity endpoints assessed. For all endpoints assessed, both 
qualitative and quantitative assessments are being developed where 
information is available.

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                          Name                                CAS No.
------------------------------------------------------------------------
Acetaldehyde............................................         75-07-0
Acetone.................................................         67-64-1
Acrolein................................................        107-02-8
Ammonium perchlorate (and associated salts).............       7790-98-9
Antimony and compounds..................................       7440-36-0
Arsenic, inorganic......................................       7440-38-2
Benzene (non-cancer endpoints)..........................         71-43-2
Benzo[a]pyrene..........................................         50-32-8
Bisphenol-A.............................................         80-05-7
Boron...................................................       7440-42-8
Bromate.................................................       7758-01-2
1,3-Butadiene...........................................        106-99-0
Cadmium.................................................       7440-43-9
Carbon tetrachloride....................................         56-23-5
Chloroethane............................................         75-00-3
Chloroform..............................................         67-66-3
Chloroprene.............................................        126-99-8
Chlorothalonil*.........................................       1897-45-6
Copper..................................................       7440-50-8
Cyclohexane.............................................        110-82-7
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
Di(2-ethylhexyl)phthalate...............................        117-81-7
Diflubenzuron...........................................      35367-38-5
Diesel emissions........................................          [N.A.]
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
Hexachlorobenzene.......................................        118-74-1
Hexachlorocyclopentadiene...............................         77-47-4
Hydrogen sulfide........................................       7783-06-4
Isopropanol.............................................         67-63-0
Methyl chloride.........................................         74-87-3
Methyl isobutyl ketone (MIBK)...........................        108-10-1
Methyl mercury (noncancer endpts).......................      22967-92-6
Methyl tert-butyl ether (MTBE)..........................       1634-04-4
Methylene chloride......................................         75-09-2
Mirex...................................................       2385-85-5
Nickel (soluble salts)..................................          [N.A.]
Nitrobenzene............................................         98-95-3
Pendimethalin...........................................      40487-42-1
Phenol..................................................        108-95-2
Quinoline...............................................         91-22-5
Pebulate*...............................................       1114-71-2
Pentachlorophenol.......................................         87-86-5
Phosgene................................................         75-44-5
Polychlorinated biphenyls (PCBs) (noncancer endpts).....       1336-36-3
Refractory ceramic fibers...............................          [N.A.]
Styrene.................................................        100-42-5
2,3,7,8-TCDD (dioxin)...................................       1746-01-6
Tetrachloroethylene (``perc'')..........................        127-18-4
Tetrahydrofuran.........................................        109-99-9
Toxaphene...............................................       8001-35-2
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
------------------------------------------------------------------------

    The following assessments in progress have been delayed and are now 
expected in FY 2003:

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                          Name                                CAS no.
------------------------------------------------------------------------
Hexahydro-1,3,5-trinitro-triazine (``RDX'').............        121-82-4
Silica (crystalline)....................................      14808-60-7
------------------------------------------------------------------------

    Completed 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. In addition, external peer review drafts of IRIS documents 
can be found via the ``What's New'' page of the IRIS web site, as 
discussed in the January 12, 2000 Federal Register notice. Interested 
parties should check the ``What's New'' page frequently for the 
availability of these drafts.
    In addition to the assessment of the individual polycyclic aromatic 
hydrocarbon (PAH) benzo[a]pyrene, EPA conducted a literature review and 
will be sponsoring a workshop on approaches to assessing the health 
effects of a larger set of PAHs. As mentioned in the January 12, 2000 
Federal Register, additional health assessments on this class of 
chemicals will be considered for initiation in FY 2001.

Assessment Development Input From External Parties

    In addition to the opportunity for public input via the IRIS 
Submission Desk described above, EPA is testing ways to involve the 
public in the development of health assessment documents that are 
submitted to EPA by external parties as supporting documents for IRIS. 
This was described in the January 12, 2000, Federal Register notice. 
Considerable expertise in assessing health risks exists outside of EPA, 
such as in other government agencies, industries, universities, 
professional organizations, and other non-governmental organizations. 
Cooperation between EPA and external parties in the assessment 
development process can improve the quality of IRIS supporting 
documents by providing greater scientific input to EPA's assessments.
    EPA announced in the January 12, 2000 and May 17, 2000, Federal 
Register notices that external parties are developing several 
assessment documents with dialogue and feedback from EPA. Currently, 
external party assessments are addressing ethylene oxide, ethylbenzene, 
styrene, toxaphene, hexachlorobenzene, and hexahydro-1,3,5-trinito-
triazine (``RDX''). When complete, EPA will consider these documents, 
in whole or in part, as possible sources or supporting documents for 
IRIS assessments. In FY 2001, EPA will continue to evaluate its 
experience with these externally-generated assessments in terms of 
process efficiency and quality of the documents produced. If the 
experience is positive, EPA will consider inviting similar involvement 
on future health assessments in the IRIS program.

Information Requested on New Assessments for FY 2001

    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 2001. The following list of substances are priorities for IRIS due 
to one or more 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 2001, with completion expected in FY 2003. 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. For all 
endpoints assessed, both qualitative and quantitative assessments are 
being developed where information is available.

[[Page 11167]]



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                   Name                               CAS No.
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Acrylamide...............................  79-06-1
Alachlor*................................  15972-60-8
Asbestos.................................  1332-21-4
Azinphos Methyl*.........................  86-50-0
Bromoxynil*..............................  1689-84-5
Chlorpyrifos*............................  2921-88-2
Diazinon*................................  333-41-5
Ethanol..................................  64-17-5
Ethion*..................................  563-12-2
Hexachlorobutadiene......................  87-68-3
Methanol.................................  67-56-1
Methidathion*............................  950-37-8
Methyl Parathion*........................  298-00-0
Metolachlor*.............................  51218-45-2
Polycyclic Aromatic Hydrocarbons (PAHs)..  [Various]
Toluene..................................  108-88-3
Triallate*...............................  2303-17-5
------------------------------------------------------------------------

Submission of Information

    As in previous Federal Registers announcing the annual IRIS agenda, 
EPA is soliciting public involvement in new assessments starting in FY 
2001. 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.

Procedures for Submission

    Similar to the process described in the January 12, 2000, 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 
(reports, papers, 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 persons to contact for additional 
information. Mail two copies of the submission to the IRIS Submission 
Desk, c/o Courtney R. Johnson, National Center for Environmental 
Assessment (8601D), U.S. Environmental Protection Agency, Washington, 
DC 20460.
    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 
will also 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 
requesting full submission of the selected material.
    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. 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 two copies, at least one of which should be unbound, to 
the IRIS Submission Desk, as described in Step 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 Manager (see FOR FURTHER INFORMATION).

    Dated: January 18, 2001.
George W. Alapas,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 01-2175 Filed 2-21-01; 8:45 am]
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