
[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26751-26755]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10935]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9670-2; Docket ID No. EPA-HQ-ORD-2007-0664]


Integrated Risk Information System (IRIS); Announcement of 2012 
Program

AGENCY: Environmental Protection Agency.

ACTION: Announcement of 2012 Program; request for information.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing 
the IRIS 2012 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.

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 www.regulations.gov 
(EPA's preferred method); by email to ord.docket@epa.gov; by mail to 
Office of Environmental Information (OEI) Docket (Mail Code: 2822T), 
U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., 
Washington, DC 20460-0001; or by hand delivery or courier to EPA Docket 
Center, EPA West, Room 3334, 1301 Constitution Avenue NW., Washington, 
DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding 
legal holidays. The telephone number for the EPA Docket Center is 202-
566-1744. Detailed instructions are

[[Page 26752]]

provided below under How to Submit Information to the Docket.
    Background: EPA's IRIS Program is a human health assessment program 
that evaluates quantitative and qualitative risk information on effects 
that may result from exposure to chemical substances found in the 
environment. Through the IRIS Program, EPA provides high quality 
science-based human health assessments to support the Agency's 
regulatory activities. The IRIS database contains information for more 
than 540 chemical substances that can be used to support the first two 
steps (hazard identification and dose-response evaluation) of the risk 
assessment process. When supported by available data, IRIS provides 
oral reference doses (RfDs) and inhalation reference concentrations 
(RfCs) for chronic noncancer health effects and cancer assessments. 
Combining IRIS toxicity values with specific exposure information, 
government and private entities use IRIS to help characterize public 
health risks of chemical substances in site-specific situations and 
thereby support risk management decisions designed to protect public 
health.
    EPA' s process for developing IRIS assessments consists of: (1) A 
comprehensive search of the current scientific literature, a data call-
in, and development of a draft IRIS health assessment; (2) internal 
EPA-wide review; (3) science consultation on the draft assessment with 
other Federal agencies and White House offices; (4) independent expert 
peer review, public review and comment, and public listening session; 
(5) revision of the assessment to address peer review and public 
comments; (6) internal EPA-wide review and interagency science 
discussion of EPA's disposition of peer review and public comments; and 
(7) clearance and posting of the final assessment on IRIS (www.epa.gov/iris).
    The Iris Agenda: As part of the IRIS process, EPA solicited 
nominations of chemicals for IRIS assessment or reassessment from EPA 
Program Offices and Regions, other Federal agencies and White House 
offices, and the public (75 FR 63827). EPA announced six general 
criteria for selection of chemicals for assessment or reassessment: (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; (5) availability of other scientific assessment 
documents that could serve as a basis for development of an IRIS 
assessment; and (6) other factors such as widespread exposure. The 
decision of when to start assessments of the selected high-priority 
chemical substances 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.
    In developing the IRIS agenda for 2012, EPA conducted literature 
searches for the nominated chemicals and made a determination as to 
whether a particular chemical had sufficient information to develop at 
least one toxicity value. EPA offices were asked to indicate which 
chemicals with sufficient data were priorities for their offices. EPA 
then considered the other criteria as listed in the Federal Register 
Notice (75 FR 63827) and the capacity of the IRIS Program to begin 
draft development for each chemical under consideration.
    EPA is soliciting public involvement in assessments on the IRIS 
agenda, including new assessments starting in 2012, 2013, and 2014. 
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 is 
soliciting 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. 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.
    This notice provides: (1) A list of assessments completed since the 
IRIS agenda was last published in October 2010 (75 FR 63827); (2) a 
list of IRIS assessments in progress; (3) a list of IRIS assessments 
that will start in 2012, 2013, and 2014; and (4) instructions to the 
public for submitting scientific information to EPA pertinent to the 
development of assessments.

Assessments Completed

    The following assessments have been completed since the last IRIS 
agenda was published in a Federal Register Notice on October 18, 2010 
(75 FR 63827).

------------------------------------------------------------------------
                          Chemical                             Cas No.
------------------------------------------------------------------------
dichloromethane (methylene chloride).......................      75-09-2
hexachloroethane...........................................      67-72-1
2,3,7,8-tetrachlorodibenzo-p-dioxin (noncancer)............    1746-01-6
tetrachloroethylene (perchloroethylene)....................     127-18-4
tetrahydrofuran............................................     109-99-9
trichloroacetic acid.......................................      76-03-9
trichloroethylene..........................................      79-01-6
urea.......................................................      57-13-6
------------------------------------------------------------------------

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 home page (www.epa.gov/iris). 
IRIS assessments for all substances listed as in progress in 2012 will 
be provided on the IRIS Web site at 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 only, and do not 
represent the Agency's final position.
    All health endpoints, cancer and noncancer, due to chronic exposure 
are being assessed unless otherwise noted. For all endpoints assessed, 
both qualitative and quantitative assessments are being developed where 
information is available.

------------------------------------------------------------------------
                 Chemical                             Cas No.
------------------------------------------------------------------------
acetaldehyde \1\.........................  75-07-0.
acrylonitrile \1\........................  107-13-1.
ammonia \1\..............................  7664-41-7.
arsenic, inorganic \1\...................  7440-38-2.
benzo(a)pyrene \1\.......................  50-32-8.
beryllium \1\............................  7440-41-7.
biphenyl \1\.............................  92-52-4.
n-butanol \1\............................  71-36-3.
tert-butanol.............................  75-65-0.
butyl benzyl phthalate \1\...............  85-68-7.
cadmium \1\..............................  7440-43-9.
chloroethane.............................  75-00-3.
chloroform\1\............................  67-66-3.
chromium VI \1\..........................  18540-29-9.
cobalt...................................  7440-48-4.
copper \1\...............................  7440-50-8.
cumulative assessment for 6 phthalates...  various.
di-n-butyl phthalate \1\.................  84-74-2.
1,2-dichlorobenzene \1\..................  95-50-1.
1,3-dichlorobenzene \1\..................  541-73-1.
1,4-dichlorobenzene \1\..................  106-46-7.
diethyl phthalate \1\....................  84-66-2.
di(2-ethylhexyl) adipate \1\.............  103-23-1.
di(2-ethylhexyl) phthalate \1\...........  117-81-7.
diisobutyl phthalate.....................  84-69-5.
diisononyl phthalate.....................  58033-90-2.
1,4-dioxane (inhalation) \1\.............  123-91-1.
dipentyl phthalate.......................  131-18-0.

[[Page 26753]]

 
ethyl tertiary butyl ether (ETBE)........  637-92-3.
ethylbenzene \1\.........................  100-41-4.
ethylene oxide (cancer)..................  75-21-8.
formaldehyde \1\.........................  50-00-0.
hexabromocyclododecane (mixed              3194-55-6, 25637-99-5.
 stereoisomers).
hexachlorobutadiene \1\..................  87-68-3.
hexahydro-1,3,5-trinitro-triazine (RDX)    121-82-4.
 \1\.
Libby amphibole asbestos.................  1332-21-4.
methanol (cancer)........................  167-56-1.
methanol (noncancer) \1\.................  167-56-1.
methyl tert-butyl ether (MTBE) \1\.......  1634-04-4.
naphthalene \1\..........................  91-20-3.
nickel (soluble salts) \1\...............  various.
halogenated platinum salts and platinum    various.
 compounds.
polychlorinated biphenyls (PCBs)           various.
 (noncancer) \1\.
polycyclic aromatic hydrocarbon (PAH)      various.
 mixtures.
styrene \1\..............................  100-42-5.
2,3,7,8-tetrachlorodibenzo-p-dioxin        1746-01-6.
 (cancer).
1,2,3-trimethylbenzene...................  526-73-8.
1,2,4-trimethylbenzene...................  95-63-6.
1,3,5-trimethylbenzene...................  108-67-8.
uranium (natural) \1\....................  7440-61-1.
vanadium pentoxide \1\...................  1314-62-1.
vinyl acetate \1\........................  108-05-4.
------------------------------------------------------------------------
\1\ Reassessment of chemical currently on IRIS.

    The cancer and noncancer assessments for inorganic arsenic, treated 
as two separate assessments in previous agendas, will be combined and 
proceed through the IRIS review process as one assessment. Similarly, 
the oral and inhalation assessments for chromium VI will be combined 
and proceed through the IRIS process as one assessment. EPA will update 
both the noncancer and cancer beryllium assessments, rather than just 
the cancer assessment.
    In January 2010, the IRIS assessment for methanol was released for 
external peer review and public comment. In June 2010, EPA decided to 
put the IRIS cancer assessment for methanol on hold pending a review of 
an underlying study by the Ramazzini Institute (RI). This review was 
conducted by an independent Pathology Working Group (PWG), jointly 
sponsored by EPA and the National Institute of Environmental Health 
Sciences (NIEHS), which was established to conduct a review of several 
RI studies including the methanol study. Based on differences of 
opinion between the RI and PWG scientists in diagnosing leukemias and 
lymphomas, EPA has decided not to rely on RI data on leukemias and 
lymphomas in IRIS assessments. This decision impacts the methanol 
cancer assessment. EPA will discontinue the peer review of the draft 
methanol cancer assessment and develop a new draft that does not rely 
on the RI study. A schedule for the development and review of the 
cancer assessment will be announced on IRIS track (www.epa.gov/iris). 
The assessment of methanol's noncancer health effects does not rely on 
data from the RI. Therefore, the assessment for the noncancer effects 
of methanol will continue through remaining steps as a separate 
assessment.
    EPA is adding 1,2,3-trimethylbenzene (TMB) to the IRIS agenda to 
complete the set of three TMB isomers. Two other isomers of TMB are 
already included on the IRIS agenda and undergoing review (1,2,4-TMB 
and 1,3,5-TMB). 1,2,3-TMB is often found in the environment with 1,2,4- 
and 1,3,5-TMB. Given this situation, and in response to comments 
received in the Agency Review and Interagency Science Consultation for 
1,2,4- and 1,3,5-TMB, EPA is adding 1,2,3-TMB to the agenda and will 
conduct assessments of all three isomers at the same time. Because the 
1,2,4- and 1,3,5-TMB assessments are already underway, EPA would 
appreciate notification of any additional literature as soon as 
possible so that this information can be included in the 1,2,3-TMB 
assessment prior to public comment and external peer review.
    The ethanol assessment is on the IRIS agenda but has not been 
started. Taking into account the complexity of the ethanol dataset, EPA 
is considering various approaches to conducting the ethanol assessment. 
EPA will revisit the priority of the ethanol assessment in FY13.

New Assessments for 2012 Agenda

    EPA developed a list of priority chemicals for 2012 from two 
sources: (1) Chemicals nominated for IRIS assessment by EPA programs, 
other Federal agencies, and the public; and (2) chemicals already on 
the IRIS agenda but delayed because of resource limitations. For newly 
nominated chemicals, EPA first considered whether sufficient data are 
available to support development of one or more IRIS toxicity values. 
For chemicals with sufficient data, EPA considered statutory, 
regulatory, or programmatic need based on the stated priorities of 
EPA's Program and Regional Offices; potential public health impact of 
the assessment; interest to other levels of government or the public; 
and whether a partially completed draft for delayed assessments or an 
assessment by another organization is available that could serve as a 
basis for developing an IRIS assessment.
    The following chemicals have been selected for inclusion in the 
2012 IRIS agenda. The projected start dates included in the table below 
indicate the U.S. fiscal year in which EPA will start or update 
literature searches for these chemicals.
    EPA is requesting information from the public for consideration in 
the development of these assessments. Instructions on how to submit 
information are provided below under How to Submit Information to the 
Docket.

------------------------------------------------------------------------
            Chemical                   Cas No.          Projected start
------------------------------------------------------------------------
antimony \1,3\.................  7440-36-0..........  FY13.
carbonyl sulfide \1,3\.........  463-58-1...........  FY12.
chlorobenzene \2,3\............  108-90-7...........  FY13.
decamethylcyclopentasiloxane     541-02-6...........  FY13.
 (D5) \2\.
octamethylcyclotetrasiloxane     556-67-2...........  FY13.
 (D4) \2\.
1,2-dichloroethane (ethylene     107-06-2...........  FY14.
 dichloride) \1,3\.
diisopropyl ether (DIPE) \1\...  108-20-3...........  FY12.
tert-amyl methyl ether           994-05-8...........  FY12.
 (TAME)``\1\.
4,4'-dimethyl-3-oxahexane        919-94-8...........  FY12.
 (TAEE) \1\.
isopropanol \1\................  67-63-0............  FY13.
manganese \1,3\................  7439-9.............  FY13.
mercury, elemental \2,3\.......  7439-96-5..........  FY14.
methyl mercury \2,3\...........  22967-92-6.........  FY14.
tungsten and related compounds   7440-33-7, various.  FY14.
 \1\.
vanadium, elemental and          ...................  FY13
 compounds \2\ various.
------------------------------------------------------------------------
\1\ Chemical was previously on the IRIS agenda but assessment was
  delayed due to resource limitations.

[[Page 26754]]

 
\2\ Chemical is a new addition to IRIS agenda.
\3\ Reassessment of chemical currently on IRIS.

    By FY14, EPA will have started all of the chemicals that were 
previously on the IRIS agenda, but delayed because of resource 
limitations, except for the chemicals that are being withdrawn from the 
agenda as described below under Withdrawn Assessments and the ethanol 
assessment, described above under Assessments in Progress. Among the 
new additions to the IRIS agenda, chlorobenzene, mercury, methyl 
mercury, and vanadium were selected for assessment because they are 
priorities for multiple EPA Program Offices and Regions and all 
chemicals have the potential for high impact on public health. While 
only two EPA Offices indicated that the siloxanes are priorities, D4 
and D5 were selected for IRIS assessment because they met other 
criteria including high potential for impact on public health and 
widespread exposure and because of the opportunity afforded to perform 
a cumulative assessment of emerging contaminants.
    One of the highest priority substances nominated for assessment was 
lead. EPA will defer a decision on the development of an IRIS 
assessment for lead until the end of 2012. EPA anticipates publication 
of a final Integrated Science Assessment (ISA) for lead during the 
summer of 2012. The ISA offers a comprehensive summary of the health 
and ecological scientific evidence and also includes information on 
lead sources, ambient air concentrations, fate and transport, exposure, 
and toxicokinetics. A draft ISA is available at http://epa.gov/ncea/isa/lead.htm. In addition, the National Toxicology Program (NTP) 
anticipates completion in 2012 of a draft Monograph on Health Effects 
of Low-Level Lead, which summarizes the health evidence in humans 
related to major effects with a focus on blood lead levels <10 ug/dL. A 
draft NTP report, available at http://ntp.niehs.nih.gov/go/36639, has 
been reviewed by an NTP Peer Review Panel. Upon completion, these 
documents will be evaluated to determine if an IRIS assessment is 
needed.
    In FY2013, before beginning draft development, EPA will conduct a 
state-of-the-science workshop on manganese. Similarly, in FY2014, EPA 
will conduct a state-of-the-science workshop on elemental mercury and 
methyl mercury. These meetings will be open to the public.

Withdrawn Assessments

    The following chemicals are withdrawn from the IRIS agenda:

------------------------------------------------------------------------
                 Chemical                              Cas No.
------------------------------------------------------------------------
alkylates.................................  various.
bisphenol A...............................  80-05-7.
mirex.....................................  2385-85-5.
refractory ceramic fibers.................  not applicable.
------------------------------------------------------------------------

    The alkylates are a distillation fraction of petroleum and are 
present in gasoline. Common alkylates found in gasoline for which IRIS 
assessments have not been recently completed include n-heptane, 
methylcyclohexane, 2-methylbutane, 2-methylpentane, 3-methylpentane, n-
octane, 2,3,3-trimethylpentane, 2,3,4-trimethylpentane, and 2,2,5-
trimethylhexane. This class of chemicals is withdrawn from the IRIS 
agenda because there are multiple chemicals in the class, many with 
limited databases. If individual alkylates with sufficient data to 
support an IRIS assessment are nominated in the future, the IRIS 
Program will consider these nominations individually. Bisphenol A is 
withdrawn because EPA is awaiting further analysis and results from the 
U.S. Food and Drug Administration and the NIEHS prior to determining 
whether Agency action under the Toxic Substances Control Act is 
required for protection of human health. Refractory ceramic fibers and 
mirex are withdrawn because they are no longer priorities for EPA.
    We continue to request the submission of any scientific information 
that you would like EPA to consider for any assessment on the IRIS 
agenda. Instructions for submitting information are provided below.
    How to Submit Information to the Docket: Submit your information, 
identified by Docket ID No. EPA-HQ-ORD-2007-0664, by one of the 
following methods:
     http://www.regulations.gov: Follow the online instructions 
for submitting comments.
     Email: ORD.Docket@epa.gov.
     Facsimile: 202-566-1753.
     Mail: Office of Environmental Information (OEI) Docket 
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200 
Pennsylvania Avenue NW., Washington, DC 20460. The telephone number is 
202-566-1752. If you provide comments by mail, please submit one 
unbound original with pages numbered consecutively, and three copies of 
the comments. For attachments, provide an index, number pages 
consecutively with the comments, and submit an unbound original and 
three copies.
     Hand Delivery: The OEI Docket is located in the EPA 
Headquarters Docket Center, EPA West Building, Room 3334, 1301 
Constitution Avenue 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. Deliveries are only accepted during the 
docket's normal hours of operation, and special arrangements should be 
made for deliveries of boxed information. If you provide comments by 
hand delivery, please submit one unbound original with pages numbered 
consecutively, and three copies of the comments. For attachments, 
provide an index, number pages consecutively with the comments, and 
submit an unbound original and three copies.
    It is EPA's policy to include all comments it receives in the 
public docket without change and to make the comments available online 
at http://www.regulations.gov, including any personal information 
provided, unless comments include information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site 
is an ``anonymous access'' system, which means that EPA will not know 
your identity or contact information unless you provide it in the body 
of your comments. If you send email comments directly to EPA without 
going through http://www.regulations.gov, your email address will be 
automatically captured and included as part of the comments that are 
placed in the public docket and made available on the Internet. If you 
submit electronic comments, EPA recommends that you include your name 
and other contact information in the body of your comments and with any 
disk or CD-ROM you submit. If EPA cannot read your comments due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comments. Electronic files should 
avoid the use of special characters and any form of encryption and be 
free of any defects or viruses. For additional information

[[Page 26755]]

about EPA's public docket, visit the EPA Docket Center homepage at 
http://www.epa.gov/epahome/dockets.htm.
    All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some 
information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
at http://www.regulations.gov or in hard copy at the OEI Docket in the 
EPA Headquarters Docket Center.
    Additional Information: For information on the docket or 
www.regulations.gov, please contact the Office of Environmental 
Information (OEI) Docket (Mail Code: 2822T), U.S. Environmental 
Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; 
telephone: 202-566-1752; facsimile: 202-566-1753; or email: 
ORD.Docket@epa.gov.
    For information on the IRIS program, contact Karen Hammerstrom, 
IRIS Program Deputy Director, National Center for Environmental 
Assessment, (Mail Code: 8601P), Office of Research and Development, 
U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460; telephone: 703-347-8642; or email: FRN 
Questions@epa.gov.
    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 hotline.iris@epa.gov.

    Dated: April 30, 2012.
Darrell A. Winner,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2012-10935 Filed 5-4-12; 8:45 am]
BILLING CODE 6560-50-P


