[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]


=======================================================================
-----------------------------------------------------------------------

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.

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

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.

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

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.

------------------------------------------------------------------------
              Substance name                           CAS No.
------------------------------------------------------------------------
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
------------------------------------------------------------------------

    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.

------------------------------------------------------------------------
                 Substance name                           CAS No.
------------------------------------------------------------------------
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
------------------------------------------------------------------------

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]
BILLING CODE 6560-50-P