Notice of Availability of Guidance for Applying Quantitative Data To Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation, 59768 [2014-23637]
Download as PDF
<![CDATA[
59768
Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Notices
Weekly receipt of Environmental Impact
Statements
Filed 09/22/2014 Through 09/26/2014
Pursuant to 40 CFR 1506.9
Notice
Section 309(a) of the Clean Air Act
requires that EPA make public its
comments on EISs issued by other
Federal agencies. EPA’s comment letters
on EISs are available at: https://
www.epa.gov/compliance/nepa/
eisdata.html.
EIS No. 20140282, Final EIS, NPS, TX,
Big Thicket National Preserve Final
General Management Plan, Review
Period Ends: 11/03/2014, Contact:
Doug Neighbor 409–951–6801.
EIS No. 20140283, Final EIS, NPS, TX,
Lake Meredith National Recreation
Area and Alibates Flint Quarries
National Monument General
Management Plan, Review Period
Ends: 11/03/2014, Contact: Arlene
Wimer 806–857–0309.
EIS No. 20140284, Draft Supplement,
FHWA, VA, U.S. Route 460 Corridor,
Comment Period Ends: 11/17/2014,
Contact: Edward S. Sundra, 804–775–
3357. The U.S. Department of
Transportation’s Federal Highway
Administration, the U.S. Army Corps
of Engineers, and the Virginia
Department of Transportation are
joint lead agencies for the above
project.
EIS No. 20140285, Final EIS, USFS, CA,
California Pacific Electricity Company
625 and 650 Electrical Line Upgrade
Project, Review Period Ends: 11/03/
2014, Contact: Robert Rodman 530–
543–2613.
EIS No. 20140286, Draft EIS, USFS, CA,
Jess Project, Klamath National Forest,
Comment Period Ends: 11/17/2014,
Contact: Angie Bell 530–842–6131.
EIS No. 20140287, Draft EIS, USFS, WA,
Mt. Baker-Snoqualmie Invasive Plant
Management, Comment Period Ends:
11/17/2014, Contact: Phyllis Reed
360–436–2332.
EIS No. 20140288, Draft EIS, BPA, OR,
WA, Walla Walla Basin Spring
Chinook Hatchery Program, Comment
Period Ends: 11/24/2014, Contact:
Donald L. Rose 503–230–3796.
mstockstill on DSK4VPTVN1PROD with NOTICES
Amended Notices
EIS No. 20140198, Draft EIS, NMFS,
WA, Two Joint State and Tribal
Resource Management Plans for Puget
Sound Salmon and Steelhead
Hatchery Programs, Comment Period
Ends: 11/24/2014, Contact: Steve
Leider 360–753–4650. Revision to the
FR Notice Published 07/25/2014;
Extending the Comment Period from
10/23/2014 to 11/24/2014.
VerDate Sep<11>2014
18:08 Oct 02, 2014
Jkt 235001
EIS No. 20140236, Final EIS, USACE,
WA, Lower Snake River Programmatic
Sediment Management Plan, Review
Period Ends: 09/22/2014, Contact:
Sandra Shelin 509–527–7265.
Revision to FR Notice Published 09/
26/2014; Correction to the Review
Period, which ended on 09/22/2014
and not 09/29/2014.
Dated: September 30, 2014.
Cliff Rader,
Director, NEPA Compliance Division, Office
of Federal Activities.
[FR Doc. 2014–23639 Filed 10–2–14; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–ORD–2014; FRL–9917–45–ORD]
Notice of Availability of Guidance for
Applying Quantitative Data To Develop
Data-Derived Extrapolation Factors for
Interspecies and Intraspecies
Extrapolation
Environmental Protection
Agency.
ACTION: Notice of availability.
AGENCY:
This notice announces the
availability of Guidance for Applying
Quantitative Data to Develop DataDerived Extrapolation Factors for
Interspecies and Intraspecies
Extrapolation (DDEF Guidance). This
document lays out methods for
calculation of factors compensating for
the application of animal toxicity data
to humans (interspecies) and for
compensating for sensitive populations
(intraspecies). The use of data to
conduct these extrapolations rather than
rely on default values advances EPA’s
policy of considering relevant data first
when conducting its chemical
assessments.
SUMMARY:
The document will be available
October 3, 2014.
ADDRESSES: The Guidance for Applying
Quantitative Data to Develop DataDerived Extrapolation Factors for
Interspecies and Intraspecies
Extrapolation is available at the EPA
Web site https://www.epa.gov/raf/DDEF/
index.htm.
FOR FURTHER INFORMATION CONTACT: Dr.
Michael Broder, Office of the Science
Advisor, Mail Code 8105R, U.S.
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460; telephone number (202) 564–
3393; fax number (202) 564–2070; or
email: broder.michael@epa.gov.
SUPPLEMENTARY INFORMATION:
Historically, EPA has employed default
DATES:
PO 00000
Frm 00030
Fmt 4703
Sfmt 9990
uncertainty factors in its computation of
toxicity values (e.g., reference
concentrations [RfC] and reference
doses [RfD]) to compensate for an
absence of data. Default uncertainty
factors have historically been based on
policy or regulatory positions rather
than on empirical data applicable to the
chemical of interest. Among the
uncertainty factors used in EPA
assessments are those compensating for
a lack of information on how well
animal models used in toxicity studies
mimic humans (interspecies) and
differences in response between the
majority of the population (central
tendency) compared with the sensitive
individual (intraspecies). With the
publication of An Examination of EPA
Risk Assessment Principles and
Practices ‘‘Staff Paper’’ published in
2004, and EPA’s Guidelines for
Carcinogen Risk Assessment, published
in 2005, the Agency announced its
policy of considering all relevant data
before applying default values.
In 2011 EPA published
Recommended Use of Body Weight3⁄4 as
the Default Method in Derivation of the
Oral Reference Dose. In that guidance
EPA listed the optimal approach as
using a physiologically-based
pharmacokinetic or other biologicallybased model with the default approach
using the ratio of body weights raised to
the 3⁄4 power.
The DDEF Guidance lays out a
computational process for using
chemical-specific data on toxicokinetics
(adsorption, metabolism, distribution
and excretion) and toxicodynamics
(response of the tissue to the active form
of the agent).
It should be noted that the DDEF
Guidance is the first EPA product to
provide a method both for quantitative
determination of relative sensitivity of
the pharmacodynamic response in an
assessment and for empirical
determination of intraspecies
sensitivity. As such, this method
provides a valuable tool for identifying
and quantifying sensitive populations
and lifestages.
Dated: August 21, 2014.
Robert Kavlock,
Interim EPA Science Advisor.
[FR Doc. 2014–23637 Filed 10–2–14; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\03OCN1.SGM
03OCN1
]]>Agencies
[Federal Register Volume 79, Number 192 (Friday, October 3, 2014)]
[Notices]
[Page 59768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23637]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2014; FRL-9917-45-ORD]
Notice of Availability of Guidance for Applying Quantitative Data
To Develop Data-Derived Extrapolation Factors for Interspecies and
Intraspecies Extrapolation
AGENCY: Environmental Protection Agency.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: This notice announces the availability of Guidance for
Applying Quantitative Data to Develop Data-Derived Extrapolation
Factors for Interspecies and Intraspecies Extrapolation (DDEF
Guidance). This document lays out methods for calculation of factors
compensating for the application of animal toxicity data to humans
(interspecies) and for compensating for sensitive populations
(intraspecies). The use of data to conduct these extrapolations rather
than rely on default values advances EPA's policy of considering
relevant data first when conducting its chemical assessments.
DATES: The document will be available October 3, 2014.
ADDRESSES: The Guidance for Applying Quantitative Data to Develop Data-
Derived Extrapolation Factors for Interspecies and Intraspecies
Extrapolation is available at the EPA Web site https://www.epa.gov/raf/DDEF/index.htm.
FOR FURTHER INFORMATION CONTACT: Dr. Michael Broder, Office of the
Science Advisor, Mail Code 8105R, U.S. Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number
(202) 564-3393; fax number (202) 564-2070; or email:
broder.michael@epa.gov.
SUPPLEMENTARY INFORMATION: Historically, EPA has employed default
uncertainty factors in its computation of toxicity values (e.g.,
reference concentrations [RfC] and reference doses [RfD]) to compensate
for an absence of data. Default uncertainty factors have historically
been based on policy or regulatory positions rather than on empirical
data applicable to the chemical of interest. Among the uncertainty
factors used in EPA assessments are those compensating for a lack of
information on how well animal models used in toxicity studies mimic
humans (interspecies) and differences in response between the majority
of the population (central tendency) compared with the sensitive
individual (intraspecies). With the publication of An Examination of
EPA Risk Assessment Principles and Practices ``Staff Paper'' published
in 2004, and EPA's Guidelines for Carcinogen Risk Assessment, published
in 2005, the Agency announced its policy of considering all relevant
data before applying default values.
In 2011 EPA published Recommended Use of Body Weight\3/4\ as the
Default Method in Derivation of the Oral Reference Dose. In that
guidance EPA listed the optimal approach as using a physiologically-
based pharmacokinetic or other biologically-based model with the
default approach using the ratio of body weights raised to the \3/4\
power.
The DDEF Guidance lays out a computational process for using
chemical-specific data on toxicokinetics (adsorption, metabolism,
distribution and excretion) and toxicodynamics (response of the tissue
to the active form of the agent).
It should be noted that the DDEF Guidance is the first EPA product
to provide a method both for quantitative determination of relative
sensitivity of the pharmacodynamic response in an assessment and for
empirical determination of intraspecies sensitivity. As such, this
method provides a valuable tool for identifying and quantifying
sensitive populations and lifestages.
Dated: August 21, 2014.
Robert Kavlock,
Interim EPA Science Advisor.
[FR Doc. 2014-23637 Filed 10-2-14; 8:45 am]
BILLING CODE 6560-50-P
