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, 48674-48677 [2013-19366]

Download as PDF 48674 Federal Register / Vol. 78, No. 154 / Friday, August 9, 2013 / Notices Executive Branch Financial Disclosure, as supplemented by the EPA in 5 CFR part 6401. In anticipation of this requirement, prospective candidates for service on the FIFRA SAP will be asked to submit confidential financial information which shall fully disclose, among other financial interests, the candidate’s employment, stocks and bonds, and where applicable, sources of research support. The EPA will evaluate the candidates financial disclosure form to assess whether there are financial conflicts of interest, appearance of a lack of impartiality or any prior involvement with the development of the documents under consideration (including previous scientific peer review) before the candidate is considered further for service on FIFRA SAP. Those who are selected from the pool of prospective candidates will be asked to attend the public meetings and to participate in the discussion of key issues and assumptions at these meetings. In addition, they will be asked to review and to help finalize the meeting minutes. The list of FIFRA SAP members participating at this meeting will be posted on the FIFRA SAP Web site at https://www.epa.gov/scipoly/sap or may be obtained from the OPP Docket or at https://www.regulations.gov. pmangrum on DSK3VPTVN1PROD with NOTICES II. Background A. Purpose of FIFRA SAP FIFRA SAP serves as the primary scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) and is structured to provide scientific advice, information and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on health and the environment. FIFRA SAP is a Federal advisory committee established in 1975 under FIFRA that operates in accordance with requirements of the Federal Advisory Committee Act. FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed by the EPA Administrator from nominees provided by the National Institutes of Health and the National Science Foundation. FIFRA established a Science Review Board consisting of at least 60 scientists who are available to the SAP on an ad hoc basis to assist in reviews conducted by the SAP. As a peer review mechanism, FIFRA SAP provides comments, evaluations and recommendations to improve the effectiveness and quality of analyses made by Agency scientists. Members of FIFRA SAP are scientists who have sufficient professional qualifications, including training and experience, to VerDate Mar<15>2010 14:54 Aug 08, 2013 Jkt 229001 provide expert advice and recommendation to the Agency. C. FIFRA SAP Documents and Meeting Minutes B. Public Meeting EPA’s background paper, related supporting materials, and charge/ questions to FIFRA SAP, will be available by approximately late September. In addition, the Agency may provide additional background documents as the materials become available. You may obtain electronic copies of these documents, and certain other related documents that might be available electronically, at https:// www.regulations.gov and the FIFRA SAP homepage at https://www.epa.gov/ scipoly/sap. FIFRA SAP will prepare meeting minutes summarizing its recommendations to the Agency approximately 90 days after the meeting. The meeting minutes will be posted on the FIFRA SAP Web site or may be obtained from the OPP Docket or at https://www.regulations.gov. As part of the Insect Resistance Management program for Bt corn Plant Incorporated Protectants (PIPs), registrants are required to conduct annual resistance monitoring of the key target insects. This monitoring program includes population sampling (performed randomly and in response to field damage), bioassays to evaluate susceptibility/resistance (traditionally with artificial insect diet), and (if necessary) remedial action plans to mitigate field resistance. Resistance monitoring for corn rootworm (CRW) has been beset by a number of technical challenges. The PIPs registered for control of CRW are considered ‘‘non-high dose,’’ meaning that a proportion of even a susceptible population can be expected to survive exposure to the Bt toxin(s). Opportunities for monitoring investigations are limited because CRW have one generation per year, undergo an obligate diapause period, and can be difficult to maintain in laboratory environments. Testing with artificial diet bioassays (as is done for lepidopteran pests of Bt corn) has yielded highly variable results which have been problematic to interpret. Taken together, these factors have complicated the establishment of workable (regulatory) definition of ‘‘resistance’’ for CRW (based on bioassay results). Several novel bioassay techniques have been developed by corn entomologists in recent years. These procedures involve testing with Bt corn plants and may be more suitable for CRW than artificial diet bioassays. Some questions remain, however, as to how these ‘‘on-plant’’ assays should be interpreted in the context of resistance determinations and whether the sensitivity of diet bioassays can be improved. EPA seeks to improve the resistance monitoring program for CRW by addressing the scientific uncertainties associated with this insect. Specifically, EPA’s charge to the panel will include the following topics: Population sampling (random vs. focused), triggers (i.e., field damage to Bt corn) for investigations of potentially resistant populations, bioassay techniques, defining resistance (in the context of bioassay results), and remedial action plans in the event of resistance to contain or limit the spread of resistant populations. PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 List of Subjects Environmental protection, Pesticides and pests. Dated: July 31, 2013. David Dix, Acting Director, Office of Science Coordination and Policy. [FR Doc. 2013–19372 Filed 8–8–13; 8:45 am] BILLING CODE 6560–50–P 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-trinitro1,3,5-triazine; and Announcement of a Public Meeting on These Preliminary Materials Environmental Protection Agency (EPA). ACTION: Notice of a series of public meetings and the availability of preliminary materials. AGENCY: 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 SUMMARY: E:\FR\FM\09AUN1.SGM 09AUN1 Federal Register / Vol. 78, No. 154 / Friday, August 9, 2013 / Notices 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: ross.christine@epa.gov (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: ross.christine@epa.gov. For information regarding the subject matter of a specific meeting, please contact the EPA representative identified on the IRIS public meeting Web site (https:// www.epa.gov/iris/publicmeeting/). SUPPLEMENTARY INFORMATION: Meeting Date October 23–24, 2013 pmangrum on DSK3VPTVN1PROD with NOTICES 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 (tertbutanol), ethyl-tert-butyl ether (ETBE), and hexahydro-1,3,5-trinitro-1,3,5triazine (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 (https:// 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. I. Information about IRIS 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. VerDate Mar<15>2010 14:54 Aug 08, 2013 Jkt 229001 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 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 48675 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 (https:// 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 exposureresponse 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 E:\FR\FM\09AUN1.SGM 09AUN1 pmangrum on DSK3VPTVN1PROD with NOTICES 48676 Federal Register / Vol. 78, No. 154 / Friday, August 9, 2013 / Notices 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. VerDate Mar<15>2010 14:54 Aug 08, 2013 Jkt 229001 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 (https://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 (https://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 tertbutanol, ETBE, and RDX. The preliminary materials for tert-butanol and ETBE are posted on the IRIS Web site (https://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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 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 https://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: • https://www.regulations.gov: Follow the on-line instructions for submitting materials. • Email: Docket_ORD@epa.gov. • 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 E:\FR\FM\09AUN1.SGM 09AUN1 pmangrum on DSK3VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 154 / Friday, August 9, 2013 / Notices 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 https:// 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 https:// www.regulations.gov or email. The https://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 https://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 VerDate Mar<15>2010 14:54 Aug 08, 2013 Jkt 229001 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 https:// www.epa.gov/epahome/dockets.htm. Docket: All documents in the docket are listed in the https:// 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 https:// 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] ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2013–0025; FRL–9392–8] Notice of Receipt of Pesticide Products; Registration Applications to Register New Uses Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: This notice announces receipt of applications to register new uses for pesticide products containing currently registered active ingredients pursuant to the provisions of section 3(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. This notice provides the public with an opportunity to comment on the applications. SUMMARY: Comments must be received on or before September 9, 2013. ADDRESSES: Submit your comments, identified by docket identification (ID) number and the EPA Registration Number or EPA File Symbol of interest as shown in the body of this document, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/contacts.htm. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/ dockets. DATES: Lois Rossi, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: BILLING CODE 6560–50–P PO 00000 48677 I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\09AUN1.SGM 09AUN1

Agencies

[Federal Register Volume 78, Number 154 (Friday, August 9, 2013)]
[Notices]
[Pages 48674-48677]
From the Federal Register Online via the Government Printing 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 (https://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: ross.christine@epa.gov 
(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: ross.christine@epa.gov. For 
information regarding the subject matter of a specific meeting, please 
contact the EPA representative identified on the IRIS public meeting 
Web site (https://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 (https://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 (https://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 (https://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 (https://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 https://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:
     https://www.regulations.gov: Follow the on-line 
instructions for submitting materials.
     Email: Docket_ORD@epa.gov.
     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 https://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 https://www.regulations.gov or email. The https://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 https://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 https://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the https://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 https://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
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