[Federal Register Volume 68, Number 24 (Wednesday, February 5, 2003)]
[Notices]
[Pages 5870-5873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2768]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-7448-2]
Integrated Risk Information System (IRIS); Announcement of 2003
Program; Request for Information and Announcement of Workshop
AGENCY: Environmental Protection Agency.
ACTION: Notice; announcement of the IRIS 2003 program and request for
scientific information on health effects that may result from exposure
to chemical substances; announcement of the stakeholder workshop on
priority-setting criteria for the assessment of 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 January 9, 2002, EPA announced the 2002 IRIS agenda
and solicited scientific information from the public for consideration
in assessing health effects from specific chemical substances. 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. This notice also announces a stakeholder
workshop on the criteria that EPA's IRIS program uses to establish
annual priorities for assessing chemical substances and provides
information for observer registration.
DATES: Please submit scientific information in response to this notice
in the form of an initial ``submission inventory'' in accordance with
the instructions in this notice by April 7, 2003.
The stakeholder workshop on criteria for establishing priorities
for assessing chemical substances for IRIS will be held March 4, 2003.
This notice includes instructions for observer registration.
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 CONTACT: For information on the IRIS program,
contact Amy Mills, Program Director, 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 exposure to chemical substances found in the environment. IRIS
currently provides information on health effects associated with
chronic exposure to 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.
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
[[Page 5871]]
and supporting documents into the IRIS data base.
This notice provides: (1) A list of the IRIS assessments completed
in FY 2002 and early FY 2003, (2) a list of the IRIS assessments in
progress that the Agency expects to complete in FY 2003-2005, (3) an
update on EPA's IRIS ``needs assessment'' report, (4) an announcement
of a stakeholder workshop on EPA's criteria for selecting chemical
substances for the annual agenda, (5) a list of the new assessments
beginning in FY 2003, and (6) instructions to the public for submitting
scientific information to EPA pertinent to the development of IRIS
assessments.
Assessments Completed in FY 2002 and Early FY 2003
The following assessments were completed and entered into IRIS in
FY 2002 and early FY 2003. These assessments were listed in the Federal
Register of January 9, 2002 (67 FR 1212). All health endpoints were
assessed. Where information was available, both qualitative and
quantitative assessments were developed.
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Substance name CAS No.
------------------------------------------------------------------------
1,3-Butadiene............................. 106-99-0
Chloroform (oral route)................... 67-66-3
1,1-Dichloroethylene...................... 75-35-4
Phenol.................................... 108-95-2
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Assessments in Progress
The following assessments are underway or generally complete and
are planned for entry into IRIS in FY 2003 or FY 2004. Those that are
likely to be delayed to FY 2005 are indicated by an asterisk (*). All
of the assessments below were listed in the January 9, 2002, 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 a double asterisk
(**) are having only oral reference dose and carcinogenicity endpoints
assessed.
Substances denoted with a triple asterisk (***) are being evaluated
for effects from acute and/or subchronic exposure, in addition to
chronic exposure. These substances are part of a pilot test to evaluate
the application of methods, procedures, and resource needs for adding
less-than-lifetime exposure duration information to IRIS. For some
substances listed, the less-than-lifetime evaluation is being initiated
in FY 2003, and may therefore be completed and made available on IRIS
sometime after the chronic exposure evaluation.
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Substance name CAS No.
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Acetaldehyde.............................. 75-07-0
Acetone................................... 67-64-1
Acrolein***............................... 107-02-8
Acrylamide................................ 79-06-1
Alachlor**................................ 15972-60-8
Ammonium perchlorate (and other 7790-98-9
perchlorate salts).
Antimony and compounds.................... 7440-36-0
Asbestos*................................. 1332-21-4
Atrazine**................................ 1912-24-9
Azinphos methyl**......................... 86-50-0
Benzene***................................ 71-43-2
Benzo(a)pyrene............................ 50-32-8
Bromoxynil**.............................. 1689-84-5
Boron..................................... 7440-42-8
Cadmium................................... 7440-43-9
Captan**.................................. 133-06-2
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
Dibutyl phthalate***...................... 84-74-2
Dichloroacetic acid....................... 79-43-6
1,2-Dichlorobenzene....................... 95-50-1
1,3-Dichlorobenzene....................... 541-73-1
1,4-Dichlorobenzene....................... 106-46-7
Diesel exhaust............................ [N.A.]
Di(2-ethylhexyl)adipate (DEHA)............ 103-23-1
Di(2-ethylhexyl)phthalate................. 117-81-7
Diflubenzuron............................. 35367-38-5
Ethalfluralin**........................... 55283-68-6
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
gamma-Hexachlorocyclohexane (Lindane)**... 58-89-9
Hexahydro-1,3,5-trinitro-triazine (RDX)... 121-82-4
Hydrogen cyanide*......................... 74-90-8
Hydrogen sulfide***....................... 7783-06-4
Isopropanol............................... 67-63-0
Methanol.................................. 67-56-1
Methidathion**............................ 950-37-8
Methomyl**................................ 16752-77-5
Methyl ethyl ketone....................... 78-93-3
Methyl isobutyl ketone (MIBK)............. 108-10-1
Methyl parathion**........................ 298-00-0
Methyl tert-butyl ether (MTBE)............ 1634-04-4
2-Methylnaphthalene....................... 91-57-6
Metolachlor**............................. 51218-45-2
Mirex..................................... 2385-85-5
Naphthalene (cancer effects; inh. route).. 91-20-3
Nickel (soluble salts).................... [N.A.--various]
Nitrobenzene.............................. 98-95-3
PAH mixtures*............................. [N.A.--various]
Pendimethalin**........................... 40487-42-1
Pebulate**................................ 1114-71-2
Pentachlorophenol......................... 87-86-5
Perfluorooctanoic acid--ammonium salt..... 3825-26-1
Perfluorooctane sulfonate--potassium salt. 2795-39-3
Phosgene***............................... 75-44-5
Polychlorinated biphenyls (PCBs-noncancer 1336-36-3
endpoints).
Propachlor**.............................. 1918-16-7
Refractory ceramic fibers................. [N.A.]
Silica (crystalline)...................... 14808-60-7
Styrene................................... 100-42-5
2,3,7,8-TCDD (dioxin)..................... 1746-01-6
Tetrachloroethylene (perchloroethylene)... 127-18-4
Tetrahydrofuran........................... 109-99-9
Thallium*................................. 7440-28-0
Toluene................................... 108-88-3
Triallate**............................... 2303-17-5
Trichlopyr**.............................. 55335-06-3
1,1,1-Trichloroethane***.................. 71-55-6
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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IRIS summaries and support documents for all substances listed
above will be provided on the IRIS Web site at http://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.
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 2003
agenda below. The notice also requested input on whether other types of
evaluations are needed on IRIS such 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
[[Page 5872]]
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. The final ``IRIS Needs Assessment''
report will be made available on the IRIS web site when it is
completed.
Stakeholder Workshop on Priority-Setting Criteria
EPA will be sponsoring a stakeholder workshop on the priority-
setting criteria for selecting chemical substances for IRIS assessment.
The purpose of the workshop is to get input from individuals and
organizations outside of EPA on the criteria EPA uses to determine the
annual IRIS agenda. Invited participants will include individuals or
organizations that have previously expressed interest in the IRIS
agenda through the IRIS Needs Assessment, the IRIS Submission Desk,
other correspondence, or related activities. The workshop will be held
March 4, 2003, from 1-5 pm at the Crystal City Marriott Hotel, 1999
Jefferson Davis Highway, Arlington, VA 22202. Versar, Inc., an EPA
contractor, will convene and facilitate the workshop. To register to
attend the workshop as an observer, contact Ms. Traci Bludis, Versar,
Inc.; telephone: (703) 750-3000, extension 449; facsimile: (703) 642-
6954; or e-mail: [email protected]. Space for observers may be
limited, therefore, registration will be accepted on a first-come,
first-served basis.
Information Requested on New Assessments for FY 2003
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 to be added to the
IRIS data base. 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 2003. The substances listed
below 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; and (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. Additional criteria for prioritizing
chemical substances are currently under consideration for developing
future IRIS agendas.
EPA may add resources to the IRIS program this year, and if so, may
publish a supplement to this FY 2003 agenda with additional priority
substances selected for assessment. EPA also plans to publish a
solicitation later in the year for public nominations for substances to
consider for assessment beginning in FY 2004.
The following IRIS health assessments have recently begun or will
be started in FY 2003, with completion expected in FY 2004 or FY 2005.
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. For all endpoints assessed, both qualitative and
quantitative assessments are being developed where information is
available. Substances denoted with a double asterisk (**) are being
evaluated for effects from acute and/or subchronic exposure, in
addition to chronic exposure. These substances, along with those
similarly indicated on the previous list of assessments in progress,
are part of a pilot test to evaluate the application of methods,
procedures, and resource needs for adding less-than-lifetime exposure
duration information to IRIS.
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Substance name CAS No.
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Aldicarb/Aldicarb sulfoxide..................... 116-06-3/1646-87-3
Aldicarb sulfone................................ 1646-88-4
Arsenic, inorganic.............................. 7440-38-2
Bromobenzene.................................... 108-86-1
Bromodichloromethane............................ 75-27-4
Bromoform....................................... 75-25-2
Cobalt.......................................... 7440-48-4
Cryptosporidium................................. [N.A.]
Dibromochloromethane............................ 124-48-1
Hexachlorocyclopentadiene*** (acute exposure 77-47-4
only).
Kepone.......................................... 143-50-0
Polybrominated diphenyl ethers (PBDEs):
Decabromodiphenyl ether (deBDE)............. 1163-19-5
Hexabromodiphenyl ether (hxBDE)............. 36483-60-0
Pentabromodiphenyl ether (PeBDE)............ 32534-81-9
Tetrabromodiphenyl ether (TeBDE)............ 40088-47-9
Propionaldehyde............................. 123-38-6
2,2,4-Trimethylpentane...................... 540-84-1
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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 2003. 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 to the IRIS Submission Desk, 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.
[[Page 5873]]
Procedures for Submission
Similar to the process described in the January 9, 2002, 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
a brief description of 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.
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 submit 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.
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 material must be submitted to the
appropriate EPA office via established procedures (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 CONTACT).
Dated: January 30, 2003.
George W. Alapas,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 03-2768 Filed 2-4-03; 8:45 am]
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