[Federal Register Volume 72, Number 245 (Friday, December 21, 2007)]
[Notices]
[Pages 72715-72719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24844]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8509-7; Docket ID No. EPA-HQ-ORD-2007-0664]


Integrated Risk Information System (IRIS); Announcement of 2008 
Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for information.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing 
the IRIS 2008 agenda and requesting scientific information on health 
effects that may result from exposure to the chemical substances on the 
agenda, including assessments that EPA is starting this year. The 
Integrated Risk Information System (IRIS) is an EPA database that 
contains the Agency's scientific positions on human health effects that 
may result from exposure to chemical substances in the environment. 
Assessments currently in progress are listed in this notice.

DATES: While EPA is not expressly soliciting comments on this notice, 
the Agency will accept information related to the substances included 
herein. Please submit any information in accordance with the 
instructions provided below.

ADDRESSES: Please submit relevant scientific information identified by 
docket ID number EPA-HQ-ORD-2007-0664, online at http://www.regulations.gov (EPA's preferred method); by e-mail to 
[email protected]; mailed to Office of Environmental Information (OEI) 
Docket (Mail Code: 2822T), U.S. Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; or by hand delivery 
or courier to EPA Docket Center, EPA West, Room 3334, 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 Word or as an 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 Dr. Abdel-Razak Kadry, IRIS 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) 564-1645, facsimile: (202) 565-0075; or e-mail: 
[email protected].

[[Page 72716]]

    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 a database of human health effects that may result from 
exposure to various chemical substances found in the environment. (EPA 
notes that information in the IRIS database has no preclusive effect 
and does not predetermine the outcome of any rulemaking. When EPA uses 
such information to support a rulemaking, the scientific basis for, and 
the application of, that information are subject to comment.) IRIS 
currently provides information on health effects associated with more 
than 500 chemical substances.
    The database 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 is an important source 
in evaluating potential public health risks from environmental 
contaminants.
    EPA's overall process for developing IRIS assessments consists of: 
(1) Publication of an annual Federal Register announcement of EPA's 
IRIS agenda and call for scientific information from the public on 
selected chemical substances; (2) a comprehensive search of the current 
scientific literature; (3) development of a draft IRIS health 
assessment utilizing state of the art scientific methods and 
guidelines; (4) internal EPA review of the draft assessment; (5) 
interagency review of the draft assessment; (6) public comment followed 
by independent external peer review of the draft assessment; (7) a 
public external peer review meeting related to the draft assessment; 
(8) preparation of a final IRIS assessment that reflects public 
comments and independent expert review; (9) interagency review of the 
final assessment; (10) EPA review and clearance of the final 
assessment; and (11) posting of the final IRIS assessment on the IRIS 
database (http://www.epa.gov/iris).

The IRIS Annual Agenda

    Each year, EPA develops a priority list of chemicals and an annual 
agenda for the IRIS program and announces new assessments under review. 
EPA uses five general criteria to set these priorities: (1) Potential 
public health impact; (2) EPA statutory, regulatory, or program-
specific implementation needs; (3) availability of new scientific 
information or methodology that might significantly change the current 
IRIS information; (4) interest to other governmental agencies or the 
public; and (5) availability of other scientific assessment documents 
that could serve as a basis for an IRIS assessment. The decision to 
assess any given chemical substance depends on available Agency 
resources. Availability of risk assessment guidance, guidelines, and 
science policy decisions may also have an impact on the timing of EPA's 
decision to assess a chemical substance.
    EPA is soliciting public involvement in assessments on the IRIS 
agenda, including new assessments starting in 2008. While EPA conducts 
a thorough literature search for each chemical substance, there may be 
unpublished studies or other primary technical sources that are not 
available through the open literature. EPA would appreciate receiving 
scientific information from the public during the information gathering 
stage for the assessments listed in this notice. Interested persons 
should provide scientific analyses, studies, and other pertinent 
scientific information. While EPA is primarily soliciting information 
on new assessments starting in 2008, the public may submit information 
on any chemical substance at any time.
    This notice provides: (1) A list of IRIS assessments in progress; 
(2) a list of new IRIS assessments starting in 2008; and (3) 
instructions to the public for submitting scientific information to EPA 
pertinent to the development of assessments.

Assessments in Progress

    The following assessments are underway. The status and planned 
milestone dates for each assessment can be found on the IRIS Track 
system, accessible from the IRIS database. 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
antimony............................  7440-36-0
arsenic, inorganic..................  7440-38-2
asbestos............................  1332-21-4
benzo[a]pyrene......................  50-32-8
beryllium (cancer)..................  7440-41-7
bromobenzene........................  108-86-1
butyl benzyl phthalate..............  85-68-7
cadmium.............................  7440-43-9
carbon tetrachloride................  56-23-5
cerium oxide and cerium compounds...  1306-38-3
chlordecone (kepone)................  143-50-0
chloroethane........................  75-00-3
chloroform..........................  67-66-3
chloroprene.........................  126-99-8
cobalt..............................  7440-48-4
copper..............................  7440-50-8
dibutyl phthalate...................  84-74-2
1,2-dichlorobenzene.................  95-50-1
1,3-dichlorobenzene.................  541-73-1
1,4-dichlorobenzene.................  106-46-7
cis-1,2-dichloroethylene............  156-59-2
trans-1,2-dichloroethylene..........  156-60-5

[[Page 72717]]

 
dichloromethane (methylene chloride)  75-09-2
di(2-ethylhexyl)adipate.............  103-23-1
di(2-ethylhexyl)phthalate...........  117-81-7
1,4-dioxane.........................  123-91-1
ethanol.............................  64-17-5
ethyl tert-butyl ether..............  637-92-3
ethylbenzene........................  100-41-4
ethylene dichloride.................  107-06-2
ethylene glycol monobutyl ether.....  111-76-2
ethylene oxide (cancer).............  75-21-8
formaldehyde........................  50-00-0
hexachlorobutadiene.................  87-68-3
hexachloroethane....................  67-72-1
hexahydro-1,3,5-trinitro-triazine     121-82-4
 (RDX).
2-hexanone..........................  591-78-6
hydrogen cyanide....................  74-90-8
isopropanol.........................  67-63-0
methanol............................  67-56-1
methyl tert-butyl ether (MTBE)......  1634-04-4
mirex...............................  2385-85-5
naphthalene.........................  91-20-3
nickel (soluble salts)..............  (various)
nitrobenzene........................  98-95-3
pentachlorophenol...................  87-86-5
perfluorooctanoic acid--ammonium      3825-26-1
 salt.
perfluorooctane sulfonate--potassium  2795-39-3
 salt.
platinum............................  7440-06-4
polycyclic aromatic hydrocarbon       various
 (PAH) mixtures.
polybrominated diphenyl ethers
tetraBDE............................  5436-43-1
pentaBDE............................  60348-60-9
hexaBDE.............................  68631-49-2
decaBDE.............................  1163-19-5
polychlorinated biphenyls (PCBs)      1336-36-3
 (noncancer).
propionaldehyde.....................  123-38-6
refractory ceramic fibers...........  not applicable
styrene.............................  100-42-5
2,3,7,8-tetrachlorodibenzo-p-dioxin.  1746-01-6
    and related compounds...........  various
1,1,2,2-tetrachloroethane...........  79-34-5
tetrachloroethylene                   127-18-4
 (perchloroethylene).
tetrahydrofuran.....................  109-99-9
thallium............................  7440-28-0
trichloroacetic acid................  76-03-9
trichloroethylene...................  79-01-6
1,2,3-trichloropropane..............  96-18-4
uranium compounds...................  7440-61-1
vinyl acetate.......................  108-05-4
------------------------------------------------------------------------

    The following assessments were completed in FY2006 and FY2007: n-
hexane; phosgene; 1,1,1-trichloroethane; 2,2,4-trimethylpentane. The 
following assessments are being withdrawn from the IRIS agenda at the 
request of the EPA Office of Water: aldicarb, aldicarb sulfoxide, and 
aldicarb sulfone. Assessments of these chemicals will be completed by 
the EPA Office of Pesticide Programs. The following assessments are 
being withdrawn by the EPA Office of Research and Development: acrolein 
(acute), benzene (acute), ethylene oxide (acute), phosgene (acute), 
hexachlorocyclopentadiene (acute), and hydrogen sulfide (acute).
    IRIS assessments for all substances listed as on-going assessments 
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 assessments are posted for public information and comment. 
These drafts will continue to be accessible via the IRIS and NCEA Web 
sites. Note that these drafts are intended for public information.

Information Requested on New Assessments for 2008

    EPA developed a list of priority chemicals for 2008 from 
nominations from the EPA programs and from the public received in 
response to the December 22, 2006, Federal Register notice requesting 
public nominations (71 FR 77017). The following chemicals were 
nominated and have been selected for inclusion in the IRIS agenda.

------------------------------------------------------------------------
          Substance name                           CAS No.
------------------------------------------------------------------------
alkylates.........................  various.
ammonia...........................  7664-41-7
tert-amyl methyl ether............  994-05-8

[[Page 72718]]

 
bisphenol A.......................  80-05-7
biphenyl..........................  92-52-4
n-butanol.........................  71-36-3
tert-butanol......................  75-65-0
carbonyl sulfide..................  463-58-1
chromium VI.......................  18540-29-9
diethyl phthalate.................  84-66-2
diisopropyl ether.................  108-20-3
4,4-dimethyl-3-oxahexane..........  919-94-8
hexabromocyclododecane (mixed       3194-55-6; 25637-99-4
 stereoisomers).
manganese.........................  7439-9
toxaphene (weathered).............  8001-35-2
1,2,4-trimethylbenzene............  95-63-6
1,3,5-trimethylbenzene............  108-67-8
tungsten..........................  7440-33-7
urea..............................  57-123-6
vanadium pentoxide................  1314-62-1
------------------------------------------------------------------------

    EPA is conducting literature searches for these chemicals in 2008. 
Based on the results of the literature searches and as EPA resources 
allow, assessments will be started for those chemicals with data that 
may support development of one or more toxicity values.
    With this IRIS agenda announcement, EPA is starting a new process 
to actively solicit information from the public at the beginning of 
assessment development. As literature searches are completed, the 
results will be posted on the IRIS Web site (http://www.epa.gov/iris). 
The public is invited to review the literature search results and 
submit additional information to EPA. Literature search results are 
currently available at http://www.epa.gov/iris for tert-amyl methyl 
ether, biphenyl, n-butanol, tert-butanol, carbonyl sulfide, diethyl 
phthalate, diisopropyl ether, hexabromocyclodecane, weathered 
toxaphene, tungsten, and urea. Additional literature searches will be 
posted in batches as they are completed. Availability will be announced 
in the Federal Register. Instructions on how to submit information are 
provided below under General Information.
    While the annual prioritization process responds to the needs 
expressed by IRIS users, EPA is also systematically updating the IRIS 
database. On a cyclical basis, the IRIS Program conducts screening-
level reviews of the available scientific literature for all chemicals 
in the IRIS database that are not under active reassessment. The 
purpose of EPA's screening level review is 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 consists of a preliminary 
search and review of the literature through standard toxicological 
bibliographic databases (titles and abstracts) and selected literature 
compilations to identify new major studies that have become available 
since the existing IRIS assessment was completed. The results of the 
screening-level review for an IRIS chemical can be found on the IRIS 
Web site (http://www.epa.gov/iris) by selecting the specific IRIS 
Summary of Interest.
    EPA has started a program to systematically update assessments on 
the IRIS database. This program addresses assessments that were 
completed more than 10 years ago and have one or more toxicity values 
for which new data or new methods of analysis have been identified that 
could possibly change a toxicity value or a cancer weight-of-evidence 
descriptor. EPA is developing a protocol for prioritizing and updating 
these assessments.
    We continue to request the submission of any scientific information 
that you would like EPA to consider in confirming the results of the 
literature screening review and literature screen verification. 
Instructions for submitting information are provided below.

General Information

    As of Monday, November 28, 2005, EPA's EDOCKET was replaced by the 
Federal Docket Management System (FDMS), the new federal government-
wide system. FDMS was created to provide a single point of access to 
all federal rulemaking activities. All materials previously found in 
EDOCKET are now available on the internet at http://www.regulations.gov.

A. How Can I Get Copies of Related Information?

    EPA has established an official public docket for this action under 
Docket ID No. EPA-HQ-ORD-2007-0664. 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 3334, 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 at 
http://www.regulations.gov may be used to submit or view public 
submissions, to 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, confidential business information (CBI), or other 
information whose disclosure is restricted by statute. Information 
claimed as CBI and other information whose disclosure is restricted by 
statute are 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

[[Page 72719]]

materials may be available electronically, you may still access any of 
the publicly available docket materials through the EPA Docket Center.

B. How and to Whom Do I Submit Information?

    Information on chemical substances listed in this notice may be 
submitted as provided in the ADDRESSES section. 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.
    EPA's preferred method for receiving submissions is via EPA's 
electronic public docket. 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.

    Dated: December 6, 2007.
Peter Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. E7-24844 Filed 12-20-07; 8:45 am]
BILLING CODE 6560-50-P