![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Integrated Risk Information System (IRIS); Announcement of 2000 Program; Request for Information
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: January 12, 2000 (Volume 65, Number 8)]
[Notices]
[Page 1863-1865]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ja00-69]
-----------------------------------------------------------------------
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
mills.amy@epa.gov. 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.desk@epa.gov. 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