[Federal Register Volume 65, Number 8 (Wednesday, January 12, 2000)]
[Notices]
[Pages 1863-1865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-732]


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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-6422-4]


Integrated Risk Information System (IRIS); Announcement of 2000 
Program; Request for Information

AGENCY: Environmental Protection Agency.

ACTION: Notice; Announcement of IRIS 2000 Program and request for 
scientific information on health effects that may result from chronic 
exposure to chemical substances.

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

SUMMARY: The Integrated Risk Information System (IRIS) is an 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 December 10, 1998, EPA announced the 1999 IRIS 
agenda and solicited scientific information from the public for 
consideration in assessing health effects from specific chemical 
substances (63 FR 68285). Most of the assessments listed are 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. This Notice also discusses public availability of draft 
assessments, and cooperation between EPA and external parties on 
assessment development.

DATES: Please submit information in response to this Notice by March 
13, 2000.

ADDRESSES: Please send relevant scientific information to the IRIS 
Submission Desk in accordance with the instructions provided under 
``Submission of Information'' in this Notice. Note the new address for 
the IRIS Submission Desk.

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 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 1999 and Early FY 2000

    The following assessments were completed and entered into IRIS in 
FY 1999 and early FY 2000. These assessments were announced in the 
Federal Register notice of December 10, 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.
------------------------------------------------------------------------
Acetonitrile..............................................       75-05-8
Benzene (inhalation carcinogenicity)......................       71-43-2
Ethylene glycol monobutyl ether...........................      111-76-2
------------------------------------------------------------------------

Assessments in Progress--Completion Planned for FY 2000 or FY 2001

    The following assessments are underway or generally complete, and 
are planned for entry into IRIS in FY 2000 or FY 2001. These 
assessments were announced in the December 10, 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.
------------------------------------------------------------------------
Acetaldehyde..............................................       75-07-0
Acetone...................................................       67-64-1
Ammonium perchlorate (and associated salts)...............     7790-98-9
Benzene (oral carcinogenicity and non-cancer endpoints)...       71-43-2
Benzo[a]pyrene............................................       50-32-8
Boron.....................................................     7440-42-8
Bromate...................................................     7758-01-2
1,3-Butadiene.............................................      106-99-0
Cadmium...................................................     7440-43-9
Chloral hydrate...........................................       75-87-6
Chlorine dioxide..........................................    10049-04-4
Chlorite (sodium salts)...................................     7758-19-2
Chloroethane..............................................       75-00-3
Chloroform................................................       67-66-3
Chloroprene...............................................      126-99-8
Copper....................................................     7440-50-8
Cyclohexane...............................................      110-82-7
Dichloroacetic acid.......................................       79-43-6
1,3-Dichloropropene.......................................      542-75-6
Di(2-ethylhexyl)phthalate.................................      117-81-7
Diflubenzuron.............................................    35367-38-5
Diesel emissions..........................................        [N.A.]
Ethylbenzene..............................................      100-41-4
Ethylene oxide............................................       75-21-8
Formaldehyde..............................................       50-00-0
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

[[Page 1864]]

 
Nickel (soluble salts)....................................        [N.A.]
Nitrobenzene..............................................       98-95-3
Pendimethalin.............................................    40487-42-1
Phenol....................................................      108-95-2
Quinoline.................................................       91-22-5
Pentachlorophenol.........................................       87-86-5
Polychlorinated biphenyls (PCBs) (noncancer endpoints)....     1336-36-3
Silica (crystalline)......................................    14808-60-7
Styrene...................................................      100-42-5
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
Vinyl chloride............................................       75-01-4
Xylenes...................................................     1330-20-7
Zinc and compounds........................................    7440-66-6
------------------------------------------------------------------------
* FY 2001--2002 completion.


    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.
    In addition to the assessment of the individual polynuclear 
aromatic hydrocarbon (PAH) benzo[a]pyrene, EPA also initiated in FY 
1999 a literature review on the health effects of a larger set of PAHs. 
Additional health assessments on this class of chemicals will be 
considered for initiation in FY 2001.
    The reassessment of Lindane [CAS No. 58-89-9] discussed in the 
previous Federal Register notice has been deleted from the IRIS agenda 
for this year due to delays in a cancer study anticipated for use in 
the reassessment.

Public Availability of Draft IRIS Assessments

    In response to public interest, and in an effort to provide greater 
transparency of the IRIS program, EPA has decided to make draft 
assessments widely available for public viewing. Concurrent with each 
external peer review period, EPA will post draft IRIS assessments on 
the Internet for public information. Although EPA is not required to 
invite comments on draft IRIS assessments or respond to individual 
comments received, EPA will consider any scientific views pertaining to 
the assessment submitted by the general public during each external 
peer review period. EPA will then summarize and address any major 
scientific issues received from the public and external peer reviewers 
in an appendix to the final IRIS Toxicological Review or other EPA 
support document for the final assessment. External peer review draft 
documents will be available from the ``What's New'' page of the IRIS 
web site at www.epa.gov/iris, along with EPA's charge to the external 
peer reviewers, and information on where the public may submit any 
scientific views for EPA's consideration. Interested parties should 
check the ``What's New'' page frequently for the availability of these 
drafts.

Information Requested on New Assessments for FY 2000

    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 2000. 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 2000, with completion expected between FY 2001 and FY 
2002. 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.

------------------------------------------------------------------------
                           Name                                CAS No.
------------------------------------------------------------------------
Acrolein..................................................      107-02-8
Antimony and compounds....................................     7440-36-0
Arsenic, inorganic........................................     7440-38-2
Bisphenol-A...............................................       80-05-7
Carbon tetrachloride......................................       56-23-5
Chlorothalonil............................................     1897-45-6
1,2-Dichlorobenzene.......................................       95-50-1
1,3-Dichlorobenzene.......................................      541-73-1
1,4-Dichlorobenzene.......................................      106-46-7
1,1-Dichloroethylene......................................       75-35-4
Ethylene dibromide........................................      106-93-4
Ethylene dichloride.......................................      107-06-2
Glyphosate................................................     1071-83-6
Hydrogen sulfide..........................................     7783-06-4
Methyl mercury (noncancer endpts.)........................    22967-92-6
Methylene chloride........................................       75-09-2
Mirex.....................................................     2385-85-5
Pebulate..................................................     1114-71-2
Phosgene..................................................       75-44-5
Refractory ceramic fibers.................................        [N.A.]
2,3,7,8-TCDD (dioxin).....................................     1746-01-6
------------------------------------------------------------------------

    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

    As in previous Federal Register notices announcing the annual IRIS 
agenda, EPA is soliciting public involvement in new assessments 
starting in FY 2000. 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 December 10, 1998, Federal 
Register notice, 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

[[Page 1865]]

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. Note that the address for the IRIS 
Submission Desk has changed.
    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. 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).

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 which are 
submitted to EPA by external parties as supporting documents for IRIS. 
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. EPA can provide scientific dialogue and feedback during the 
development of external parties' assessments.
    For several assessments in progress now, specifically for the 
chemical substances Ethylene oxide, Styrene, and Toxaphene, external 
parties are developing assessment documents with dialogue and feedback 
from EPA. EPA will then consider these documents, in whole or in part, 
as possible sources or supporting documents for IRIS assessments. Over 
the coming year, EPA will evaluate its experience with these three 
externally-generated assessments in terms of process efficiency and 
quality of the documents produced. If the experience is positive, EPA 
will invite similar involvement on future health assessments in the 
IRIS program.

    Dated: January 5, 2000.
William H. Farland,
Director, National Center for Environmental Assessment.
[FR Doc. 00-732 Filed 1-11-00; 8:45 am]
BILLING CODE 6560-50-P