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[Federal Register Volume 69, Number 26 (Monday, February 9, 2004)]
[Notices]
[Pages 5971-5976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2711]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-7619-8]

Integrated Risk Information System (IRIS); Announcement of 2004 
Program; Request for Information

AGENCY: Environmental Protection Agency.

ACTION: Notice; announcement of IRIS 2004 program agenda and request 
for scientific information on human health effects that may result from 
exposure to chemical substances.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
IRIS 2004 agenda and requesting scientific information on health 
effects that may result from exposure to the chemical substances for 
which EPA is starting assessments this year.
    The Integrated Risk Information System (IRIS) is an EPA data base 
that contains the Agency's scientific consensus positions on human 
health effects that may result from exposure to chemical substances in 
the environment. On February 5, 2003 (68 FR 5870) and later 
supplemented on August 13, 2003 (68 FR 48359), EPA announced the 2003 
IRIS agenda, with the solicitation of scientific information from the 
public for consideration in assessing health effects from specific 
chemical substances. Many of these assessments are on-going or near 
completion. All assessments completed in FY03 and early FY04 are listed 
in this notice. This notice also describes some of EPA's efforts to 
improve the IRIS program.

DATES: Please submit any scientific information in response to this 
notice in accordance with the instructions provided at the end of this 
notice by April 9, 2004.

ADDRESSES: Please submit relevant scientific information identified by 
docket ID number ORD-2003-0016, online at http://www.epa.gov/edocket 
(EPA's preferred method); by e-mail to [email protected]; mailed to 
EPA Docket Center, Environmental Protection Agency, Mailcode: 2822T, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; or by hand 
delivery or courier to EPA Docket Center, EPA West, Room B102, 1301 
Constitution Ave., NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. 
Monday through Friday, excluding legal holidays. Comments on a disk or 
CD-ROM should be formatted in Wordperfect or ASCII file, avoiding the 
use of special characters and any form of encryption, and may be mailed 
to the mailing address above.

FOR FURTHER INFORMATION CONTACT: For information on the IRIS program, 
contact Amy Mills, Program Director, National Center for Environmental 
Assessment, (mail code 8601D), Office of Research and Development, U.S. 
Environmental Protection Agency, Washington, DC 20460; telephone: (202) 
564-3204, facsimile: (202) 565-0075; or e-mail: [email protected].
    For general questions about access to IRIS, or the content of IRIS, 
please call the IRIS Hotline at (202) 566-1676 or send electronic mail 
inquiries to [email protected].

SUPPLEMENTARY INFORMATION:

Background

    IRIS is an EPA data base containing Agency 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 more than 500 chemical 
substances.
    The data base includes 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. Combined with specific situational exposure 
assessment information, the information in IRIS may be used as a source 
in evaluating potential public health risks from environmental 
contaminants.
    EPA's overall process for developing IRIS assessments consists of: 
(1) An annual Federal Register announcement of EPA's IRIS agenda and 
call for scientific information from the public on selected chemical 
substances; (2) a search of the scientific literature; (3) development 
of IRIS summaries and support documents; (4) agency review; (5) 
external peer review; (6) management review and approval; (7) entry of 
IRIS summaries and support documents into the IRIS data base (http://www.epa.gov/iris).

The IRIS Annual Agenda

    Each year, EPA develops a list of priority chemical substances and 
an annual agenda for the IRIS program. EPA uses four general criteria 
to set these priorities: (1) EPA statutory, regulatory, or program-
specific implementation needs; (2) availability of new scientific 
information or methodology that might significantly change the current 
IRIS information; (3) interest to other levels of government or the 
public; and (4) availability of other

[[Page 5972]]

scientific assessment documents such that only a modest additional 
effort would be needed to complete the review and documentation for 
IRIS. The decision to assess any given chemical substance hinges on 
available Agency resources. Availability of risk assessment guidance, 
guidelines, and science policy decisions may also have an effect on the 
timing of EPA's decision to assess a chemical substance.
    Consistent with previous Federal Register notices announcing the 
annual IRIS agenda, EPA is soliciting public involvement in new 
assessments starting in FY 2004. 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 appreciate receiving 
scientific information from the public during the information gathering 
stage for the list of ``new assessments'' provided in this notice. 
Interested persons should provide scientific analyses, studies, and 
other pertinent scientific information. Also note, if you have 
submitted information previously to the IRIS Submission Desk, there is 
no need to resubmit that information. While EPA is primarily soliciting 
information on new 2004 assessments announced in this notice, the 
public may submit information on any chemical substance at any time.
    This notice provides: (1) A list of the IRIS assessments completed 
in FY 2003 and early FY 2004; (2) a list of the IRIS assessments in 
progress that the Agency expects to complete in FY 2004-2005; (3) a 
list of IRIS assessments requiring a more extensive effort; (4) a list 
of IRIS assessments deleted from the 2003 agenda; (5) a list of new 
IRIS assessments starting in FY 2004; (6) a new approach to 
systematically update IRIS; (7) an announcement of improvements 
underway to the IRIS program; and (8) instructions to the public for 
submitting scientific information to EPA pertinent to the development 
of IRIS assessments.

Assessments Completed in Late FY 2003 and Early FY 2004

    The following assessments were completed and entered into IRIS in 
FY 2003 and early FY 2004. These assessments were listed in the Federal 
Register of February 5, 2003 (68 FR 5870). All health endpoints 
associated with chronic exposure, cancer and noncancer, were assessed 
unless otherwise noted. Where information was available, both 
qualitative and quantitative assessments were developed.

------------------------------------------------------------------------
           Substance name                           CAS No.
------------------------------------------------------------------------
Acetone.............................  67-64-1
Acrolein............................  107-02-8
Benzene (noncancer).................  71-43-2
1,3-Butadiene.......................  106-99-0
Cyclohexane.........................  110-82-7
Dichloroacetic acid.................  79-43-6
Diesel engine exhaust...............  [N.A.]
Hydrogen sulfide....................  7783-06-4
Methyl ethyl ketone.................  78-93-3
Methyl isobutyl ketone..............  108-10-1
2-Methylnaphthalene.................  91-57-6
Xylenes.............................  1330-20-7
------------------------------------------------------------------------

Assessments in Progress

    The following assessments are underway or generally complete, and 
are planned for entry into IRIS in FY 2004 or FY 2005. All health 
endpoints due to chronic exposure, 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.

------------------------------------------------------------------------
           Substance name                           CAS No.
------------------------------------------------------------------------
Acetaldehyde........................  75-07-0
Acrylamide..........................  79-06-1
Acrylonitrile.......................  107-13-1
Aldicarb/Aldicarb sulfoxide.........  116-06-3/1646-87-3
Aldicarb sulfone....................  1646-88-4
Benzo(a)pyrene......................  50-32-8
Beryllium (cancer effects)..........  7440-41-7
Boron...............................  7440-42-8
Bromobenzene........................  108-86-1
Bromodichloromethane................  75-27-4
Bromoform...........................  75-25-2
Cadmium.............................  7440-43-9
Carbon tetrachloride................  56-23-5
Chloroethane........................  75-00-3
Chloroform (inhalation route).......  67-66-3
Copper..............................  7440-50-8
Cryptosporidium.....................  [N.A.]
Dibromochloromethane................  124-48-1
Dibutyl phthalate...................  84-74-2
1,2-Dichlorobenzene.................  95-50-1
1,3-Dichlorobenzene.................  541-73-1
1,4-Dichlorobenzene.................  106-46-7
Di(2-ethylhexyl)adipate (DEHA)......  103-23-1
Di(2-ethylhexyl)phthalate...........  117-81-7
Ethanol.............................  64-17-5

[[Page 5973]]

 
Ethylbenzene........................  100-41-4
Ethylene dibromide..................  106-93-4
Ethylene dichloride.................  107-06-2
Ethylene glycol monobutyl ether       111-76-2
 (cancer effects).
Hexachlorobutadiene.................  87-68-3
n-Hexane............................  110-54-3
Hydrogen cyanide....................  74-90-8
Isopropanol.........................  67-63-0
Kepone..............................  143-50-0
Methanol............................  67-56-1
Methylene chloride (Dichloromethane)  75-09-2
Mirex...............................  2385-85-5
Naphthalene (cancer effects; inh.     91-20-3
 route).
Nickel (soluble salts)..............  [N.A.--various]
Nitrobenzene........................  98-95-3
PAH mixtures........................  [N.A.--various]
Pentachlorophenol...................  87-86-5
Perfluorooctanoic acid--ammonium      3825-26-1
 salt.
Perfluorooctane sulfonate--potassium  2795-39-3
 salt.
Phosgene (acute exposure; inhalation  75-44-5
 route).
Polybrominated diphenyl ethers        [N.A.--various]
 (PBDEs):.
Refractory ceramic fibers...........  [N.A.]
Styrene.............................  100-42-5
Tetrahydrofuran.....................  109-99-9
Thallium............................  7440-28-0
Toluene.............................  108-88-3
Trichloroacetic acid................  76-03-9
1,1,1-Trichloroethane...............  71-55-6
1,2,3-Trichloropropane..............  96-18-4
2,2,4-Trimethylpentane..............  540-84-1
Uranium (natural)...................  7440-61-1
Vinyl acetate.......................  108-05-4
Zinc and compounds..................  7440-66-6
------------------------------------------------------------------------

Update of the 2003 IRIS Agenda

    EPA has taken active steps to reconsider and update the list of 
chemical substances on the 2003 IRIS agenda to better reflect the 
assessments currently underway and corresponding time frames for 
completion. To that end, EPA has carefully reviewed the chemical 
assessments on the 2003 agenda and determined that some will need more 
time for completion due to a higher level of complexity. Highly complex 
assessments often lead EPA to identify new research needs, apply new 
methodologies, or conduct multiple, in-depth, high level external 
scientific peer reviews to ensure the application of sound science. The 
following chemical assessments will therefore require a more extensive 
effort.

------------------------------------------------------------------------
           Substance name                           CAS No.
------------------------------------------------------------------------
Ammonium Perchlorate (and other       7790-98-9
 perchlorate salts).
Arsenic, inorganic..................  7440-38-2
Asbestos (noncancer effects)........  1332-21-4
Ethylene oxide (cancer effects).....  75-21-8
Formaldehyde........................  50-00-0
Methyl tert-butyl ether (MTBE)......  1634-04-4
Tetrachloroethylene                   127-18-4
 (perchloroethylene).
Polychlorinated biphenyl (PCBs-       1336-36-3
 noncancer endpoints).
2,3,7,8-TCDD (dioxin)...............  1746-01-6
Trichloroethylene...................  79-01-6
------------------------------------------------------------------------

    In addition, anticipation of new data, emerging methodology, or 
lack of immediate Agency resources provide the basis for placing the 
following chemical assessments on a longer time frame for completion. 
This includes substances denoted with an asterisk (*), which are being 
evaluated for effects from acute and/or other less-than-lifetime 
exposure durations. These substances are part of a pilot test to 
evaluate the application of methods, procedures, and resource needs for 
adding health effects information for less-than-lifetime exposure 
duration to IRIS. This effort was announced in the February 5, 2003 (68 
FR 5870) Federal Register.

------------------------------------------------------------------------
           Substance name                           CAS No.
------------------------------------------------------------------------
Acrolein*...........................  107-02-8
Benzene*............................  71-43-2
Chloroprene.........................  126-99-8
Cobalt..............................  7440-48-4
Dibutyl phthalate*..................  84-74-2

[[Page 5974]]

 
Ethylene oxide*.....................  75-21-8
Hexachloropentadiene*...............  77-47-4
Hexahydro-1,3,5-trinitro-triazine     121-82-4
 (RDX).
Hydrogen sulfide*...................  7783-06-4
Phosgene*...........................  75-44-5
Propionaldehyde.....................  123-38-6
1,1,1-Trichloroethane*..............  71-55-6
------------------------------------------------------------------------

Assessments Deleted From the IRIS Agenda

    EPA is deleting from the IRIS agenda a group of pesticides that 
will not be assessed through the IRIS process. This step is being taken 
to more efficiently utilize Agency resources, given that the Office of 
Pesticide Programs (OPP) has a large assessment program evaluating 
these chemicals. Under the 1996 Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), EPA requests relevant scientific data from 
pesticide registrants and develops health assessments based on that 
information. EPA is considering the means for providing electronic 
public access to pesticide assessments conducted under FIFRA. The 
following pesticides listed in the February 5, 2003 (68 FR 5870) 
Federal Register are therefore removed from the IRIS agenda for FY2004.

------------------------------------------------------------------------
           Substance name                           CAS No.
------------------------------------------------------------------------
Alachlor............................  15972-60-8
Atrazine............................  1912-24-9
Azinophos methyl....................  86-50-0
Bromoxynil..........................  1689-84-5
Captan..............................  133-06-2
Chlorothalonil......................  1897-45-6
Chlorpyrifos........................  2921-88-2
Diazinon............................  333-41-5
Diflubenzuron.......................  35367-38-5
Ethalfluralin.......................  55283-68-6
Ethion..............................  563-12-2
Glyphosate..........................  1071-83-6
Lindane.............................  58-89-9
Methidathion........................  950-37-8
Methomyl............................  16752-77-5
Methyl parathion....................  298-00-0
Metolachlor.........................  51218-45-2
Pebulate............................  1114-71-2
Pendamethalin.......................  40487-42-1
Propachlor..........................  1918-16-7
Triallate...........................  2303-17-5
Trichlopyr..........................  55335-06-3
------------------------------------------------------------------------

    In addition to these pesticides, EPA will remove Silica 
(crystalline) (CAS No. 14808-60-7), and Antimony and compounds (7440-
36-0) due to limited EPA resources and lower overall priority at this 
time.
    IRIS summaries and support documents for all substances listed as 
on-going assessments in FY 2004 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.

Information Requested on New Assessments for FY 2004

    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 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 2004 based on specific criteria.
    EPA developed the list of priority substances for FY 2004 by 
sorting chemical nominations from the EPA programs and the public 
according to the following considerations: (1) Multiple nominations 
were received for a chemical in response to the August 2003 FRN 
requesting nominations (68 FR 48359); (2) a nomination met multiple 
criteria among (a) statutory, regulatory or programmatic need, (b) 
interest to other levels of government or the public, and (c) 
availability of other assessment documents for use in developing an 
IRIS assessment. To refine the list of nominations meeting multiple 
criteria, high priority was given to EPA programs' priority 
nominations; (3) significant new health effects information is 
available on which to base an assessment; and (4) Agency resources are 
available to conduct the assessment. Available health effects 
information and EPA resources are considered critical for selecting a 
chemical for assessment. EPA's priority-setting approach for the IRIS 
agenda was discussed at a public stakeholder workshop, announced in the 
February 5, 2003 FRN (68 FR 5870) and held on March 4, 2003. The 
primary recommendation from this workshop was that EPA should be more 
transparent in explaining why

[[Page 5975]]

chemicals are selected for the IRIS agenda by providing a specific 
rationale for each selection. EPA's rationales are therefore given 
below.
    Based on EPA's prioritization process described above, the 
following IRIS health assessments have been selected for start up in FY 
2004, with completion expected in FY 2006. The Agency is requesting 
information from the public for consideration in the development of 
these assessments. For all endpoints assessed, both qualitative and 
quantitative assessments will be developed where information is 
available.

------------------------------------------------------------------------
         Substance name              CAS No.              Reason
------------------------------------------------------------------------
1,2-Dichloroethylene...........        540-59-0  RCRA hazard
                                                  identification and
                                                  corrective action
                                                  need. New scientific
                                                  information is
                                                  available to update
                                                  IRIS.
1,4-Dioxane....................        123-91-1  CERCLA site cleanup
                                                  need. New scientific
                                                  information is
                                                  available to update
                                                  IRIS. Public interest.
Ethyl tertiary butyl ether.....        637-92-3  CAA and SDWA need.
                                                  Scientific information
                                                  is available.
Lead (update qualitative              7349-92-1  CERCLA and RCRA site
 discussion).                                     cleanup need. New
                                                  scientific information
                                                  is available to update
                                                  IRIS. Public interest.
------------------------------------------------------------------------

Systematic Update of IRIS Data Base

    While the annual prioritization process responds to the needs 
expressed by IRIS users, EPA is also systematically updating the IRIS 
data base. The IRIS Program has conducted a screening-level review of 
the available scientific literature for all chemicals in the IRIS data 
base. The purpose of EPA's screening level review was to reach 
preliminary determinations regarding the likelihood that a full 
reassessment based on an evaluation of new health effects literature 
could potentially result in significant changes to existing toxicity 
values or cancer weight-of-evidence designations. The process consisted 
of a preliminary search and review of the literature through standard 
toxicological bibliographic data bases (titles and abstracts) and 
selected literature compilations to identify new major studies that 
have become available since the existing IRIS assessment was completed. 
Screening-level reviews were completed for 460 chemicals in the IRIS 
data base, that is, essentially all chemicals in the data base with the 
exception of those that are on the current IRIS agenda and are being 
fully reassessed. For 291 of the 460 chemicals reviewed (about 60%), no 
major new health effects studies were found that would be likely to 
significantly change existing toxicity values. These findings have been 
added to the ``EPA Review and Documentation'' sections of each 
individual IRIS Summary.
    EPA plans to use findings from this literature screen as a basis 
for systematically updating IRIS by performing a more in-depth review 
of the extant health data. This more in-depth review will seek to 
confirm results from the IRIS literature screening review. For those 
chemicals confirmed to be without new health information to change the 
existing assessment, EPA will update IRIS summaries to indicate the 
currency of scientific information upon which the assessment was based.
    We are requesting the submission of any scientific information that 
you would like EPA to consider in confirming the results of the 
literature screening review. You can locate the screening-level 
literature review findings for a chemical assessment on the IRIS Web 
site (http://www.epa.gov/iris) by selecting the specific chemical 
summary of interest and scrolling down to the ``EPA Documentation and 
Review'' section of the reference dose, reference concentration, and 
cancer assessments.

Improvements to the IRIS Program

    EPA has taken steps to improve the timeliness, quality, 
transparency, and consistency of IRIS assessments through a series of 
program reforms. EPA has plans to expand its central IRIS Staff to 
better manage the program and ensure scientific quality and 
consistency. In addition, the IRIS program will conduct more of its 
external scientific peer reviews by panel meetings rather than by mail 
reviews. This step is being taken to provide the best possible 
scientific review of each assessment. In addition, panel peer review 
meetings are open to the public for observation, making the review 
process more transparent. Further, EPA is now positioning the external 
peer review step at the end of the IRIS assessment review process, 
strengthening the role of peer review in informing EPA's final 
decision-making. Future funding levels, when provided by Congress, may 
affect actual program implementation and the resulting numbers of 
assessments completed and/or initiated.

General Information

A. How Can I Get Copies of Related Information?

    EPA has established an official public docket for this action under 
Docket ID No. ORD 2003-0016. The official public docket is the 
collection of materials that is available for public viewing at the 
Office of Environmental Information (OEI) Docket in the EPA Docket 
Center, EPA West, Room B102, 1301 Constitution Ave, NW., Washington, 
DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 
4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744, and the 
telephone number for the OEI Docket is (202) 566-1752.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
submissions, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Once in the system, select ``search,'' 
then key in the appropriate docket identification number.
    It is important to note that EPA's policy is that public 
submissions, whether submitted electronically or in paper, will be made 
available for public viewing in EPA's electronic public docket as EPA 
receives them and without change, unless the submission contains 
copyrighted material, CBI, or other information whose disclosure is 
restricted by statute. Information claimed as CBI and other information 
whose disclosure is restricted by statute is not included in the 
official public docket or in EPA's electronic public docket. EPA's 
policy is that copyrighted material, including copyrighted material 
contained in a public comment, will not be placed in EPA's electronic 
public docket but will be available only in printed, paper form in the 
official public docket. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket

[[Page 5976]]

materials through the EPA Docket Center.

B. How and To Whom Do I Submit Scientific Information?

    You may submit scientific information as provided in the ADDRESSES 
section. Please submit scientific information within 60 days of this 
notice, provide all information (studies, reports, articles, etc.) you 
wish to submit. Please ensure that your submissions are submitted 
within the specified period. Information received after the close of 
the submission period will be marked ``late.'' Late submissions may be 
considered if time permits. Your submission should specify the chemical 
substance to which your information pertains, CASRN (Chemical Abstract 
Service Registry Number), and the topic or aspect of the assessment 
that is being addressed (e.g., carcinogenicity, mode of action). In 
addition, when you submit results of new health effects studies 
concerning existing substances on IRIS, you should include a specific 
explanation of how the study results could change the information in 
IRIS. All citations should be listed in scientific citation format, 
that is, author(s), title, journal, and date. Include names, addresses 
and telephone numbers of person(s) to contact for additional 
information.
    If you submit electronic information, EPA recommends that you 
include your name, mailing address, and an e-mail address or other 
contact information in the body of your submission and with any disk or 
CD ROM you submit. This ensures that you can be identified as the 
submitter of the information and allows EPA to contact you in case EPA 
cannot read your information due to technical difficulties or needs 
further information on the substance of your submission. Any 
identifying or contact information provided in the body of submitted 
information will be included as part of the submission information that 
is placed in the official public docket, and made available in EPA's 
electronic public docket. If EPA cannot read your information due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your information.
    Your use of EPA's electronic public docket to submit information to 
EPA electronically is EPA's preferred method for receiving submissions. 
The electronic public docket system is an ``anonymous access'' system, 
which means EPA will not know your identity, e-mail address, or other 
contact information unless you provide it in the body of your 
submission. In contrast to EPA's electronic public docket, EPA's 
electronic mail (e-mail) system is not an ``anonymous access'' system. 
If you send e-mail directly to the Docket without going through EPA's 
electronic public docket, your e-mail address is automatically captured 
and included as part of the submission that is placed in the official 
public docket, and made available in EPA's electronic public docket.
    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).

    Dated: February 3, 2004.
Peter Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. 04-2711 Filed 2-6-04; 8:45 am]
BILLING CODE 6560-50-P
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