[Federal Register Volume 77, Number 146 (Monday, July 30, 2012)]
[Notices]
[Pages 44613-44614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18409]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2012-0579; FRL-9706-3]
Notice of Availability of the External Review Draft of Framework
for Human Health Risk Assessment To Inform Decision Making
AGENCY: U.S. Environmental Protection Agency.
ACTION: Notice of availability.
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SUMMARY: The U.S. Environmental Protection Agency (EPA) Office of the
Science Advisor (OSA) announces a 60-day public comment period for the
external review draft of ``A Framework for Human Health Risk Assessment
to Inform Decision Making.'' This document was developed as part of an
agencywide program by the EPA Risk Assessment Forum. The EPA is
releasing this draft document solely for the purpose of seeking public
comment prior to external peer review. The document will undergo
independent peer review during an expert peer review meeting that will
be convened, organized, and conducted by a contractor of the EPA in
2012. The date of the external peer review meeting will be announced in
a subsequent Federal Register notice. All comments received by the
docket closing date September 28, 2012, will be shared with the
external peer review panel for their consideration. Comments received
after the close of the comment period may be considered by the agency
when it finalizes the document. This document has not been formally
disseminated by the EPA. This draft document does not represent and
should not be construed to represent the EPA policy, viewpoint, or
determination. Members of the public may obtain the external review
draft from www.regulations.gov; or www.epa.gov/raf/FrameworkHHRA.htm or
from Julie Fitzpatrick via the contact information below.
This draft document describes a framework for conducting human
health risk assessments that are responsive to the needs of decision
making processes at the EPA. The document was developed by the EPA, to
provide guidance to scientists and decision makers in the EPA.
DATES: All comments received by the docket closing date September 28,
2012 will be shared with the external peer review panel for their
consideration. Comments received beyond that time may be considered by
the EPA when it finalizes the document.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
ORD-2012-0579, and by one of the following methods:
Internet: Follow the online instructions for submitting
comments in www.regulations.gov.
Email: [email protected].
Mail: ORD Docket, U.S. Environmental Protection Agency,
Mail Code: 28221T, 1200 Pennsylvania Avenue NW., Washington, DC 20460.
Hand Delivery: The EPA Docket Center (EPA/DC), Room 3334,
EPA West Building, 1301 Constitution Avenue NW., Washington, DC 20004,
Attention Docket ID EPA-HQ-ORD-2012-0579. Deliveries are only accepted
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. Special arrangements should be made for deliveries of boxed
information.
Instructions: Direct your comments to Docket ID EPA-HQ-ORD-2012-
0579. The EPA policy is that all comments received will be included in
the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes 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 by statute through www.regulations.gov or
email. The www.regulations.gov Web site is an ``anonymous access''
system, which means the EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to the EPA, without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, the EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit. If the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should avoid the use
of special characters, any form of encryption, and be free of any
defects or viruses.
Docket: All documents in the docket are listed in the
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
[[Page 44614]]
available only in hard copy. Publicly available docket materials are
available either electronically in www.regulations.gov or in hard copy
at the ORD Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution
Avenue NW., Washington, DC. The 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, and the
telephone number for the ORD Docket is (202) 566-1752.
FOR FURTHER INFORMATION CONTACT: Julie Fitzpatrick, Office of the
Science Advisor, Mail Code 8105R, U.S. Environmental Protection Agency,
1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number:
(202) 564-4212; fax number: (202) 564-2070, Email:
[email protected].
SUPPLEMENTARY INFORMATION: The EPA has an established history of
conducting human health risk assessments. The Framework is intended to
foster increased implementation of existing agency guidance for
conducting human health risk assessments and improve the utility of
risk assessment in the decision making process.
In developing the Framework the recommendations presented in the
National Research Council's report Science and Decisions: Advancing
Risk Assessment have been taken into consideration. Specifically, this
Framework addresses the recommendations that the EPA formalize and
implement planning, scoping and problem formulations in the risk
assessment process and that the agency adopt a framework for risk-based
decision making.
The Framework highlights the important roles of planning and
scoping as well as problem formulation in designing a risk assessment.
In accordance with longstanding agency policy, it also emphasizes the
importance of scientific review and public involvement. The Framework
presents the concept of ``fit for purpose'' to address the development
of risk assessments and associated products that are suitable and
useful for informing risk management decisions. This Framework will
enhance the agency's emphasis on the importance of transparency of the
human health risk assessment and decision making.
This document is not intended to supersede existing agency
guidance; rather by citing and discussing existing guidance in the
context of the framework it is intended to foster increased
implementation of agency guidance.
Dated: July 20, 2012.
Glenn Paulson,
Science Advisor.
[FR Doc. 2012-18409 Filed 7-27-12; 8:45 am]
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