[Federal Register Volume 78, Number 154 (Friday, August 9, 2013)]
[Notices]
[Pages 48674-48677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19366]


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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9845-1; EPA-HQ-ORD-2009-0229, ORD-2013-0111, ORD-2013-0430]


Announcement of the IRIS Public Meeting Schedule for Calendar 
Years 2013 and 2014; Announcement of the Availability of Preliminary 
Materials for tert-Butyl Alcohol, Ethyl tert-Butyl Ether, and 
Hexahydro-1,3,5-trinitro-1,3,5-triazine; and Announcement of a Public 
Meeting on These Preliminary Materials

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of a series of public meetings and the availability of 
preliminary materials.

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

SUMMARY: EPA's Integrated Risk Information System (IRIS) Program is 
committed to proactive stakeholder engagement, increased transparency, 
and using the best available science in IRIS assessments. In accordance 
with the recently announced enhancements of the IRIS Program, EPA is 
announcing a series of public meetings for calendar years 2013 and 2014 
to obtain public

[[Page 48675]]

input at specific stages in the process of developing an IRIS 
assessment.
    EPA is also announcing the availability of preliminary materials 
for three chemicals, tert-butyl alcohol (tert-butanol), ethyl-tert-
butyl ether (ETBE), and hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX), 
which will be discussed at the first public meeting scheduled for 
October 23-24, 2013. The preliminary materials for tert-butanol and 
ETBE are posted on the IRIS Web site, and the preliminary materials for 
RDX will be posted approximately 60 days before the meeting. These 
materials are being released for public viewing and comment prior to 
the public meeting on October 23-24, 2013, which will provide an 
opportunity for the IRIS Program to engage in early discussions (before 
the IRIS assessments have been prepared) with stakeholders and the 
public on data that may be used to identify health hazards and 
characterize exposure-response relationships.

DATES: The 2013 and 2014 IRIS public meetings will be held on the dates 
specified below. They will begin at 10:00 a.m. and end at 5:00 p.m., 
Eastern Time, or earlier, if comments and discussions have been 
completed. For planning purposes, a 2-day time period has been reserved 
for the meetings, but the actual duration will be specified when the 
topics are identified for each meeting. The meeting dates are set, but 
topics will be specified in the draft agendas provided for each meeting 
throughout the year. All future announcements and information about the 
meetings planned for 2013 and 2014, and the availability of preliminary 
materials for any chemicals undergoing review by the IRIS Program, will 
be posted on the IRIS Web site (http://www.epa.gov/iris/publicmeetings/
). Meeting information will be posted well in advance (generally 60 
days) of each meeting; no further announcements for the 2013 and 2014 
public meetings or the availability of preliminary materials will be 
made in the Federal Register. In the event there are no materials to be 
presented or discussed for any of the set meeting dates, a notice 
canceling the meeting will be posted on the IRIS Web site.

Meeting Date

    October 23-24, 2013

Topics

tert-Butyl alcohol (tert-Butanol)
Ethyl tert-butyl ether (ETBE)
Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX)
    The following meeting dates are set. Topics will be specified well 
in advance of each meeting.

December 12-13, 2013
February 26-27, 2014
April 23-24, 2014
June 25-26, 2014
September 3-4, 2014
October 29-30, 2014
December 15-16, 2014

ADDRESSES: The public meetings announced in this notice will be held at 
an EPA conference room at One Potomac Yard (South Building), 2777 South 
Crystal Drive, Arlington, Virginia, 22202. To gain entrance to this EPA 
building, attendees must register at the security desk in the lobby and 
present photo identification. A webinar and teleconference line will 
also be available for registered attendees/speakers. Broad public 
participation will ensure that EPA uses the best available science in 
risk assessment. For those who are unable to attend in person, EPA 
encourages participation via the webinar or teleconference line.
    Information on Services for Individuals with Disabilities: EPA 
welcomes public attendance at the IRIS public meetings and will make 
every effort to accommodate persons with disabilities. For information 
on access or services for individuals with disabilities, contact 
Christine Ross, IRIS Staff, Environmental Protection Agency, National 
Center for Environmental Assessment, Mail Code: 8601P; telephone: 703-
347-8592; facsimile: 703-347-8689; or email: [email protected] 
(reference the October 23-24, 2013 IRIS public meeting) and include 
your name and contact information.

FOR FURTHER INFORMATION CONTACT: For general information about IRIS 
public meetings, please contact Christine Ross, IRIS Staff, 
Environmental Protection Agency, National Center for Environmental 
Assessment (NCEA), Mail Code: 8601P; telephone: 703-347-8592; 
facsimile: 703-347-8689; or email: [email protected]. For 
information regarding the subject matter of a specific meeting, please 
contact the EPA representative identified on the IRIS public meeting 
Web site (http://www.epa.gov/iris/publicmeeting/).

SUPPLEMENTARY INFORMATION:

I. Information about IRIS

    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 the highest quality 
science-based human health assessments to support the Agency's 
regulatory activities and decisions to protect public health. The IRIS 
database contains information for more than 500 chemical substances 
that can be used to support the first two steps (hazard identification 
and dose-response evaluation) of the human health risk assessment 
process. When supported by available data, IRIS provides health effects 
information and toxicity values for health effects (including cancer 
and effects other than cancer). Government and others combine IRIS 
toxicity values with exposure information to characterize public health 
risks of chemical substances; this information is then used to support 
risk management decisions designed to protect public health.

II. IRIS Public Meetings

    Public meetings will be held approximately every 2 months beginning 
on October 23-24, 2013. Materials for the public meetings will be 
posted on the IRIS Web site (http://www.epa.gov/iris/publicmeetings/) 
well in advance of the meeting (generally 60 days). The meetings will 
provide an opportunity for the public to provide input on preliminary 
materials prior to development of the draft assessment and provide 
input on drafts of assessments and charges to the peer review panels 
prior to external peer review. The planned meeting dates for calendar 
years 2013 and 2014 are: October 23-24, 2013; December 12-13, 2013; 
February 26-27, 2014; April 23-24, 2014; June 25-26, 2014; September 3-
4, 2014; October 29-30, 2014; and December 15-16, 2014.
    In step 1 of the IRIS process (development of the draft 
assessment), EPA will release preliminary materials comprised of draft 
literature search strategies describing the processes for identifying 
and screening scientific literature and the literature search results, 
and preliminary evidence tables and preliminary exposure-response 
arrays summarizing key characteristics and findings from critical 
studies that EPA proposes to consider in identifying hazards and 
characterizing exposure-response relationships. EPA will hold a public 
meeting to discuss these materials. In step 4 of the IRIS process 
(public review and comment/independent expert peer review), EPA will 
release the draft assessment and draft peer review charge for public 
comment and also hold a public meeting to discuss these materials.
    The draft literature search strategies, preliminary evidence 
tables, and preliminary exposure-response arrays are responsive to the 
National Research Council (NRC) 2011 report Review of the Environmental 
Protection Agency's

[[Page 48676]]

Draft IRIS Assessment of Formaldehyde, in which the NRC recommended 
ways to improve the development of IRIS assessments. The literature 
search strategies, which describe the processes for identifying 
scientific literature, screening studies for consideration, and 
selecting studies to include in evidence tables, are responsive to NRC 
recommendations regarding systematic review of the scientific 
literature. The preliminary evidence tables and preliminary exposure-
response arrays are responsive to the NRC recommendation for presenting 
key study data in a standardized manner.
    EPA welcomes all comments on the draft literature search 
strategies, preliminary evidence tables, and preliminary exposure-
response arrays, including comments on:
     The clarity and transparency of the materials;
     the approach for identifying pertinent literature;
     the selection of studies for data extraction to 
preliminary evidence tables and exposure-response arrays;
     methodological considerations that could affect the 
interpretation of or confidence in study results; and
     additional studies published or nearing publication that 
may provide data for the evaluation of human health hazard or exposure-
response relationships.
    The IRIS Program believes that public involvement can be most 
beneficial at the early stages of developing an assessment. Releasing 
the draft literature search strategy, preliminary evidence tables, and 
exposure response arrays early will ensure that critical research is 
not omitted and communicates to the public why critical studies were 
chosen for further evaluation, helping frame major scientific issues 
and ultimately leading to more efficient production of assessments. In 
order to promote such early public involvement and increase 
transparency, EPA will in many cases be releasing materials that 
reflect preliminary deliberations that are subject to further evolution 
as the assessment continues. Consequently, meeting materials provided 
at the early stage of an assessment, such as preliminary evidence 
tables, have not been subjected to external peer review, and they do 
not constitute EPA policy, nor represent any Agency determination. Such 
materials are being distributed with the sole objective of facilitating 
a public meeting that is intended to promote the use of the best 
available science and improve the utility and clarity of IRIS 
assessments.

III. Meeting Registration and Presentations

    Registrants will be required to provide their name, title, 
affiliation, sponsor (if different from affiliation), and contact 
information. If you intend to request time on the agenda to make a 
specific presentation, please register no later than 30 days before the 
meeting to attend in person or via webinar/teleconference. All other 
participants should register no later than 7 days before the meeting. 
Participants that want to make a specific presentation should indicate 
such in their registration and provide the length of time required. In 
general, presentations should be no more than 30 minutes. Please submit 
any written materials to the appropriate docket number for the subject 
chemical, as specified in Section III of this notice, no later than 7 
days before the meeting. If there are more requests for presentations 
than time allows, the time limit for each presentation will be 
adjusted. During the meeting, remote attendees and individuals 
attending the meeting in person are welcome to make comments, ask 
questions, and participate in the dialogue. Details regarding 
registration procedures (in person, via webinar, or teleconference) 
will be posted on the IRIS Web site (http://www.epa.gov/iris/publicmeeting/).

IV. Meeting Materials and Public Involvement

    Materials for the public meetings will be posted well in advance 
(generally 60 days) of each meeting on the IRIS Web site (http://www.epa.gov/iris/publicmeeting/). A limited number of paper copies will 
be available from the Information Management Team, NCEA; telephone: 
703-347-8561; facsimile: 703-347-8691. If you request a paper copy, 
please provide your name, mailing address, and the title of the 
document you are requesting.

V. October 23-24, 2013, Public Meeting on tert-Butanol, ETBE and RDX

    The October 23-24, 2013 public meeting will be devoted to 
discussing the preliminary materials for tert-butanol, ETBE, and RDX. 
The preliminary materials for tert-butanol and ETBE are posted on the 
IRIS Web site (http://www.epa.gov/iris/publicmeeting/), and the 
preliminary materials for RDX will be posted approximately 60 days 
before the meeting on or about August 23, 2013. The tert-butanol 
materials will be discussed first, followed by ETBE and RDX. EPA may 
add additional chemicals to the agenda if materials become available in 
time to allow adequate notice to the public. If additional chemicals 
are added to the October 23-24, 2013 meeting agenda, they will be 
posted on the IRIS Web site approximately 60 days before the meeting on 
or about August 23, 2013. A more detailed agenda for the meeting will 
be posted on the IRIS Web site shortly after speaker registration 
closes.
    The preliminary evidence tables and preliminary exposure-response 
arrays should be regarded solely as representing the data on each 
endpoint that have been identified as a result of the draft literature 
search strategy. They do not reflect any conclusions about hazard 
identification or dose-response assessment. After obtaining public 
input and conducting additional study evaluation and data integration, 
EPA will revise these materials to support hazard identification and 
dose-response assessment in the draft Toxicological Reviews for tert-
butanol, ETBE, and RDX.
    For the October 23-24, 2013 meeting, if you intend to request time 
on the agenda to make a specific presentation, please register no later 
than September 23, 2013. All other participants should register no 
later than October 16, 2013. Please submit any written materials 
(including scheduled presentation materials) to the appropriate docket 
number specified in Section III of this notice no later than October 
16, 2013. If there are more requests for presentations than time 
allows, the time limit for each presentation will be adjusted. Details 
regarding registration procedures (in person, via webinar, or 
teleconference) will be posted on the IRIS Web site.

VI. How to Submit Materials to the Docket at http://www.regulations.gov

    General Instructions: EPA invites the public to submit comments and 
other relevant information regarding the chemicals discussed at a 
public meeting to the appropriate docket number established for each 
chemical. Such data, information, or comments may be submitted to the 
appropriate docket identified by the Docket ID number by one of the 
following methods:
     http://www.regulations.gov: Follow the on-line 
instructions for submitting materials.
     Email: [email protected].
     Facsimile: 202-566-9744.
     Mail: Office of Environmental Information (OEI) Docket 
(Mail Code: 28221T), U.S. Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460. The telephone number is 
202-566-1752. If you provide materials by mail, please submit one 
unbound original with pages numbered

[[Page 48677]]

consecutively, and three copies of the materials. 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 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. 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.
    Instructions: Direct your tert-butanol materials to Docket ID No. 
EPA-HQ-ORD-2013-0111, ETBE materials to EPA-HQ-ORD-2009-0229, and RDX 
materials to EPA-HQ-ORD-2013-0430. Please submit your materials as 
early as possible. It is EPA's policy to include all materials it 
receives in the public docket without change and to make the materials 
available online at http://www.regulations.gov, including any personal 
information provided, unless materials 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 materials. 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 materials that are 
placed in the public docket and made available on the Internet. If you 
submit electronic materials, EPA recommends that you include your name 
and other contact information in the body of your materials and with 
any disk or CD-ROM you submit. If EPA cannot read your materials due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your materials. 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 about EPA's 
public docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: 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.
    Instructions for Submitting Information to the tert-Butanol Docket: 
The October 23-24, 2013 public meeting announced in this Federal 
Register will discuss tert-butanol. The docket number for tert-butanol 
is EPA-HQ-ORD-2013-0111. Persons submitting relevant information on 
tert-butanol should follow the general instructions provided above 
using the tert-butanol docket number.
    Instructions for Submitting Information to the ETBE Docket: The 
October 23-24, 2013 public meeting announced in this Federal Register 
will discuss ETBE. The docket number for ETBE is EPA-HQ-ORD-2009-0229. 
Persons submitting relevant information on ETBE should follow the 
general instructions provided above using the ETBE docket number.
    Instructions for Submitting Information to the RDX Docket: The 
October 23-24, 2013 public meeting announced in this Federal Register 
will discuss RDX. The docker number for RDX is EPA-HQ-ORD-2013-0430. 
Persons submitting relevant information on RDX should follow the 
general instructions provided above using the RDX docker number.

    Dated: August 2, 2013.
Lynn Flowers,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2013-19366 Filed 8-8-13; 8:45 am]
BILLING CODE 6560-50-P