
[Federal Register Volume 77, Number 146 (Monday, July 30, 2012)]
[Notices]
[Pages 44613-44614]
From the Federal Register Online via the Government Printing 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: ORD.Docket@epa.gov.
     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: 
fitzpatrick.julie@epa.gov.

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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