[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.
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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
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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.
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Substance name CAS No.
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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
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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.
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Substance name CAS No.
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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
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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.
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Substance name CAS No.
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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
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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.
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Substance name CAS No.
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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.
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Substance name CAS No. Reason
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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.
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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]
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