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, 33752-33753 [2011-14294]

Download as PDF 33752 Federal Register / Vol. 76, No. 111 / Thursday, June 9, 2011 / Notices policies affecting future labeling of insect repellents. The ultimate goal of this activity is to help the consumer to effectively use the information on the label to select the insect repellent product most likely to meet their needs and readily understand label instructions regarding safe product use. Responses to this collection of information are voluntary. One survey would be conducted over the life of this ICR. The collected information could be used to revise insect repellent product labels and to create other user friendly consumer information materials. By enabling consumers to make better choices in regard to purchasing and using products intended to protect their health, EPA will more effectively carry out its mandate to protect the public from unreasonable risks to human health. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 15 minutes per response. Burden is defined in 5 CFR 1320.3(b). Respondents/Affected Entities: members of the general public would participate in the survey. Estimated Number of Potential Respondents: 3000. Frequency of Response: One time. Estimated Total Annual Hour Burden: 750 hours. Estimated Total Annual Cost: $15,675. Changes in the Estimates: This is a new collection. Dated: June 3, 2011. John Moses, Director, Collection Strategies Division. [FR Doc. 2011–14300 Filed 6–8–11; 8:45 am] BILLING CODE 6560–50–P 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 Environmental Protection Agency (EPA). ACTION: Notice of document availability for public comment. mstockstill on DSK4VPTVN1PROD with NOTICES AGENCY: 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- SUMMARY: VerDate Mar<15>2010 17:56 Jun 08, 2011 Jkt 223001 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 https://www.regulations.gov; or https://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 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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 https:// 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 https:// www.regulations.gov or e-mail. The https://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 https:// 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 https:// 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 https:// 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 E:\FR\FM\09JNN1.SGM 09JNN1 33753 Federal Register / Vol. 76, No. 111 / Thursday, June 9, 2011 / Notices 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 toxicantinduced response (toxicodynamics); intraspecies differences in chemical disposition (toxicokinetics); and intraspecies differences in toxicantinduced 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 DataDerived 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] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–9316–1] Modification of the Expiration Date for the National Pollutant Discharge Elimination System General Permit for Stormwater Discharges From Construction Activities on Tribal Lands Within the Southeastern United States Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: EPA Region 4 proposes to modify the expiration date of the National Pollutant Discharge Elimination System (NPDES) general permit authorizing the discharge of stormwater from construction activities on Tribal Lands within the states of Alabama, Florida, Mississippi and North Carolina. This NPDES construction general permit (CGP), hereinafter referred to as ‘‘the Region 4 CGP,’’ was issued on September 1, 2009, with an expiration date of August 31, SUMMARY: Category mstockstill on DSK4VPTVN1PROD with NOTICES Industry ......... 2011. EPA Region 4 is proposing to extend the expiration date from August 31, 2011, to September 1, 2012. No other revisions are being proposed to the Region 4 CGP. The purpose of extending the expiration date is to ensure that there is no lapse in permit coverage prior to the effective date of the issuance of a new permit, which has been proposed for public review and comment in a separate action. Information about the proposed new permit, hereinafter referred to as ‘‘the new National CGP,’’ can be found at https://cfpub.epa.gov/npdes/stormwater/ cgp.cfm. EPA is proposing a modification to the Region 4 CGP that would extend the expiration date from August 31, 2011, to September 1, 2012. If the proposed modification is finalized, the Region 4 CGP would expire at midnight, on September 1, 2012, or on the effective date of the new National CGP, whichever is earlier. Comments on the proposal to modify the expiration date of the Region 4 CGP must be postmarked by July 11, 2011. DATES: FOR FURTHER INFORMATION CONTACT: Alanna Conley or Michael Mitchell of the Stormwater and Nonpoint Source Section, Water Protection Division, Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, GA 30303; telephone number: (404) 562–9443 or (404) 562–9303; fax number: (404) 562–8692; e-mail address: conley.alanna@epa.gov or mitchell.michael@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? If a discharger chooses to apply for coverage under the Region 4 CGP, the permit provides specific requirements for preventing contamination of waterbodies from stormwater discharges from the following construction activities: North American Industry Classification System (NAICS) Code Examples of affected entities Construction site operators disturbing 1 or more acres of land, or less than 1 acre but part of a larger common plan of development or sale if the larger common plan will ultimately disturb 1 acre or more, and performing the following activities: Building, Developing and General Contracting ............................................................................................ Heavy Construction ...................................................................................................................................... EPA does not intend the preceding table to be exhaustive, but provides it as a guide for readers regarding entities likely to be regulated by this action. VerDate Mar<15>2010 19:07 Jun 08, 2011 Jkt 223001 This table lists the types of activities that EPA is now aware of that could potentially be affected by this action. Other types of entities not listed in the PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 table could also be affected. To determine whether your facility is affected by this action, you should carefully examine the definition of E:\FR\FM\09JNN1.SGM 09JNN1 233 234

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.regulations.gov; or https://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 
https://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 https://www.regulations.gov or e-mail. The https://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 https://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 https://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 https://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]
BILLING CODE 6560-50-P
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