Document ID: EPA-HQ-ORD-2009-0694-0001
Agency: epa
Document Type: Notice
Title: Draft Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors, etc.; Availability
Posted Date: 2011-06-09T04:00Z

[Federal Register Volume 76, Number 111 (Thursday, June 9, 2011)]
[Notices]
[Pages 33752-33753]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14294]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2009-0694; FRL-9316-6]

Notice of Availability of the External Review Draft of the 
Guidance for Applying Quantitative Data To Develop Data-Derived 
Extrapolation Factors for Interspecies and Intraspecies Extrapolation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of document availability for public comment.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing a 45-
day public comment period for the External Review Draft of ``Guidance 
for Applying Quantitative Data to Develop Data-Derived Extrapolation 
Factors for Interspecies and Intraspecies Extrapolation.'' 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, which 
will be convened, organized, and conducted by an EPA contractor in 
2011. 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 July 25, 2011 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 EPA when it finalizes the 
document. This document has not been formally disseminated by EPA. This 
draft guidance does not represent and should not be construed to 
represent EPA policy, viewpoint, or determination. Members of the 
public may obtain the draft interim guidance from http://www.regulations.gov; or http://www.epa.gov/raf/DDEF/index.htm or from 
Dr. Michael Broder via the contact information below.
    This draft Guidance for Data Derived Extrapolation Factors document 
outlines approaches for developing factors for inter- and intra-species 
extrapolation based on data describing toxicokinetic and/or 
toxicodynamic properties of particular agent(s). The draft document was 
developed to provide guidance for EPA staff in evaluating such data 
and/or information and to provide information to the regulated 
community and other interested parties about deriving and implementing 
extrapolation factors derived from data instead of defaults.

DATES: All comments received by the docket closing date July 25, 2011 
will be shared with the external peer review panel for their 
consideration. Comments received beyond that time may be considered by 
EPA when it finalizes the document.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
ORD-2009-0694, by one of the following methods:
     http;//www.regulations.gov: Follow the on-line 
instructions for submitting comments.
     E-mail: ord.docket@epa.gov.
     Mail: ORD Docket, Environmental Protection Agency, 
Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460
     Hand Delivery: EPA Docket Center (EPA/DC), Room 3334, EPA 
West Building, 1301 Constitution Avenue, NW., Washington, D.C. 20460, 
Attention Docket ID No EPA-HQ-ORD-2009-0694. 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 No. EPA-HQ-ORD-
2009-0694. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available online at 
http://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 http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site 
is an ``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA, without 
going through http://www.regulations.gov, your e-mail 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, 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 EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, 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 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 
in http://www.regulations.gov or in hard copy at the ORD Docket, EPA/
DC, EPA West, Room 3334, 1301 Constitution Ave., 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

[[Page 33753]]

number for the ORD Docket is (202) 566-1752.

FOR FURTHER INFORMATION CONTACT: Dr. Michael W. Broder, Office of the 
Science Advisor, Mail Code 8105-R, U.S. Environmental Protection 
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone 
number: (202) 564-3393; fax number: (202) 564-2070, E-mail: 
broder.michael@epa.gov.

SUPPLEMENTARY INFORMATION: Key goals for the U.S. EPA include improving 
the transparency, objectivity and scientific basis for health risk 
assessment. In 2005, a WHO-sponsored effort produced guidance on the 
development of Chemical-Specific Adjustment Factors (CSAFs). CSAFs are 
intended to replace default uncertainty factor values for inter- and 
intraspecies extrapolation in health risk assessment. The U.S. EPA 
recognizes differences between the WHO guidance and typical Agency risk 
assessment practices, policies and guidance. EPA's Risk Assessment 
Forum convened a technical panel that initiated work on developing 
draft guidance for use in replacing default values for inter- and 
intraspecies uncertainty factors with science-based extrapolation 
factors. The draft document has been reviewed by EPA's Risk Assessment 
Forum and Science and Technology Policy Council and approved for 
external review. In 2010, the document was sent to the National Science 
and Technology Council (NSTC) Committee on Environment and Natural 
Resources, Toxics and Risk Subcommittee for informal review and 
comment. The draft document is now available for public comment.
    The draft document has been structured and developed in accordance 
with existing Agency policies on health risk assessment. The draft 
document provides guidance for the evaluation of data describing 
interspecies differences in chemical disposition (toxicokinetics); 
interspecies differences in toxicant-induced response (toxicodynamics); 
intraspecies differences in chemical disposition (toxicokinetics); and 
intraspecies differences in toxicant-induced response (toxicodynamics). 
The document maintains the subdivision of the interspecies and 
intraspecies uncertainty factors into toxicokinetic and toxicodynamic 
components specified in the U.S. EPA Inhalation Reference Concentration 
methodology (U.S. EPA, 1994). EPA will consider all peer review and 
public comments in finalizing Guidance for Applying Quantitative Data 
to Develop Data-Derived Extrapolation Factors for Interspecies and 
Intraspecies Extrapolation.

    Dated: May 26, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-14294 Filed 6-8-11; 8:45 am]
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