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: http://

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. 

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. 

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] 

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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 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. 

DATES: 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 http://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 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] 

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