[Federal Register Volume 77, Number 235 (Thursday, December 6, 2012)]
[Notices]
[Pages 72858-72860]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29507]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-9758-4; Docket ID No. EPA-HQ-ORD-2012-0830]
Toxicological Review of Inorganic Arsenic (Cancer and Noncancer
Effects): In Support of Summary Information on the Integrated Risk
Information System (IRIS)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of a public stakeholder workshop to inform the
development of a state of the science toxicological review of inorganic
arsenic (cancer and noncancer effects) in support of the IRIS program.
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SUMMARY: The inorganic arsenic (iAs) public stakeholder workshop is
designed to inform the planning for EPA's toxicological review of
chronic exposure to iAs (cancer and noncancer effects), which EPA
intends to post in the IRIS database. Workshop participants will be
asked to highlight significant new and emerging research, discuss
methods for evaluating literature, identify critical research issues
(including mode of action) that may impact the toxicological review,
and discuss approaches for dose-response. The ultimate goals of the
workshop are to ensure that while developing the toxicological review,
EPA provides public stakeholders an opportunity to inform the
toxicological review and transparently communicates how EPA will
produce a toxicological review that meets the needs of Agency
stakeholders and partners.
DATES: The public stakeholder workshop will begin at 8:00 a.m. on
January 8, 2013, and end at 5:00 p.m. on January 9, 2013.
ADDRESSES: The iAs public stakeholder workshop will be held at the U.S.
EPA, 109 T.W. Alexander Drive, Research Triangle Park, North Carolina
27711. To attend the workshop in person, register no later than 12:00
p.m. on January 2, 2013, by contacting Susan Blaine via email: EPA_Arsenic@icfi.com or by telephone: 703-225-2471 (reference the iAs
Public Stakeholder Workshop and include your name, title, affiliation,
full address, and contact information). You can also register via the
Internet at http://tinyurl.com/EPA-Arsenic-2013. Space is limited, and
reservations will be accepted on a first-come, first-served basis.
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To attend the workshop via webinar/video conference, register no
later than 12:00 p.m. on January 7, 2013, by contacting Susan Blaine
via email: EPA_Arsenic@icfi.com or by phone: 703-225-2471 (reference
the ``iAs Public Stakeholder Workshop'' and include your name, title,
affiliation, full address, and contact information). You can also
register via the Internet at http://tinyurl.com/EPA-Arsenic-2013.
During the meeting, webinar attendees and individuals attending the iAs
public stakeholder workshop in person are welcome to make comments or
ask questions of presenters. All attendees may submit materials via
http://www.regulations.gov (Docket ID No. EPA-HQ-ORD-2012-0830). All
materials submitted before 12:00 p.m. on January 2, 2013, will be
included for consideration during the iAs public workshop. However,
there will be multiple opportunities for public input to inform the
EPA's toxicological review of chronic exposure to iAs (cancer and
noncancer effects).
Information on Services for Individuals with Disabilities: EPA
welcomes public attendance at the iAs public stakeholder workshop and
will make every effort to accommodate persons with disabilities. For
information on access or services for individuals with disabilities,
contact Susan Blaine by telephone: 703-225-2471, by facsimile: 703-934-
3740 (reference the iAs public stakeholder workshop and include your
name and contact information), or by email: EPA_Arsenic@icfi.com
(reference the iAs public stakeholder workshop and include your name
and contact information).
Additional Information
Workshop participants will be encouraged to think broadly about the
body of iAs scientific evidence and how it can be best used to generate
a toxicological review for iAs. They will be invited to participate in
an open dialogue regarding ways in which this evidence could most
effectively be used in the toxicological review that will serve as the
scientific and technical foundations for the Agency's decisions.
Specifically, workshop discussions will provide important input as EPA
considers the appropriate design, scope, and methods used in the
toxicological review of iAs and participants may provide individual
advice to EPA. This toxicological review, in turn, will inform risk
management decisions by Agency stakeholders and partners. Panelists
participating in the workshop will represent a wide range of external
experts, as well as EPA staff, with various areas of expertise (e.g.,
epidemiology, human and animal toxicology, systematic review, risk
assessment, dose-response, and mode of action).
In addition to the iAs public stakeholder workshop, the National
Academy of Sciences (NAS) is planning to hold a public workshop on
aspects of IRIS toxicological review of iAs. EPA will consider the key
issues and recommendations from the NAS and stakeholders in developing
a draft toxicological review of iAs. Upon completion of the draft, the
public will have an opportunity to review and provide comments and NAS
will conduct an external peer review. The draft toxicological review
for iAs will be revised in response to the NAS recommendations and
public comments. The final toxicological review will be posted in the
IRIS database.
For updated information on the iAs public stakeholder meeting,
please refer to the following Web site: http://www.epa.gov/iris/.
Alternatively, please contact John Cowden, Ph.D., U.S. Environmental
Protection Agency, National Center for Environmental Assessment, Mail
Code: B243-01, 109 T.W. Alexander Drive, Durham, NC 27711; telephone:
919-541-3667; facsimile: 919-541-0245; or email: cowden.john@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Information About IRIS
EPA's IRIS 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. 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.
Combined with specific exposure information, government and private
entities use IRIS to help characterize public health risks of chemical
substances in a site-specific situation and thereby support risk
management decisions designed to protect public health.
II. How To Submit Materials to the Docket at http://www.regulations.gov
Submit your materials, identified by Docket ID No. EPA-HQ-ORD-2012-
0830, by one of the following methods:
http://www.regulations.gov: Follow the online 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 Avenue 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 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 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.
Instructions: Direct your materials to Docket ID No. EPA-HQ-ORD-
2012-0830. Please ensure that your materials are submitted within the
specified submission period. Materials received after the closing date
will be marked ``late,'' and may only be considered if time permits. 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
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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.
Dated: November 29, 2012.
Debra B Walsh,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2012-29507 Filed 12-5-12; 8:45 am]
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