[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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