Harmonization in Interspecies Extrapolation: Use of BW3/4, 7958-7959 [E6-2146]

Download as PDF 7958 Federal Register / Vol. 71, No. 31 / Wednesday, February 15, 2006 / Notices in close proximity to rice fields in southern Louisiana. The great majority of crawfish ponds (at least 75%) are close enough to rice fields to be affected by the management practices used in rice. All of the insecticides currently registered for use against the rice water weevil in Louisiana are toxic to crawfish. The use of ethofenprox for weevil control has one significant advantage over currently used liquid products in that it is formulated as a granular and thus there is far less potential for drift. The Applicant states that the estimated economic loss if no effective weevil controls are available is over 8 million dollars. The Applicant proposes to make no more than two applications of 0.9% ethofenprox to 255,000 acres of rice in Louisiana between March 1 and August 1, 2006. A maximum of 45,645 pounds of active ingredient will be required. This notice does not constitute a decision by EPA on the application itself. The regulations governing section 18 of FIFRA require publication of a notice of receipt of an application for a specific exemption proposing a first food use of a chemical. The notice provides an opportunity for public comment on the application. The Agency, will review and consider all comments received during the comment period in determining whether to issue the specific exemption requested by the Louisiana Department of Agriculture and Forestry. List of Subjects Environmental protection, Pesticides and pests. Dated: January 31, 2006. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. [FR Doc. 06–1308 Filed 2–14–06; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY [FRL–8031–9; EPA–HQ–Docket ID No. ORD– 2006–0116] Harmonization in Interspecies Extrapolation: Use of BW3⁄4 as Default Method in Derivation of the Oral RfD Environmental Protection Agency (EPA). ACTION: Notice of public comment period. cprice-sewell on PROD1PC66 with NOTICES AGENCY: SUMMARY: EPA is announcing a 60-day public comment period for the draft document titled, ‘‘Harmonization in Interspecies Extrapolation: Use of BW3⁄4 as Default Method in Derivation VerDate Aug<31>2005 13:17 Feb 14, 2006 Jkt 208001 of the Oral RfD’’ (EPA/630/R–06/001), which was prepared by the EPA’s Risk Assessment Forum (Forum). EPA is releasing this draft document solely for the purpose of predissemination peer review under applicable information quality guidelines. This document has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy or determination. EPA will consider any public comments submitted in accordance with this notice when revising the document. DATES: The 60-day public comment period begins February 15, 2006, and ends April 17, 2006. Technical comments should be in writing and must be received by EPA by April 17, 2006. ADDRESSES: The draft, ‘‘Harmonization in Interspecies Extrapolation: Use of BW3⁄4 as Default Method in Derivation of the Oral RfD,’’ is available primarily via the Internet on the Risk Assessment Forum’s home page at https:// cfpub.epa.gov/ncea/raf/index.cfm. A limited number of paper copies are available from the Technical Information Staff, NCEA–W; telephone: 202–564–3261; facsimile: 202–565– 0050. If you are requesting a paper copy, please provide your name, your mailing address, and the document title, ‘‘Harmonization in Interspecies Extrapolation: Use of BW3⁄4 as Default Method in Derivation of the Oral RfD.’’ Comments may be submitted electronically, by mail, by facsimile, or by hand delivery/courier. Please follow the detailed instructions provided in the SUPPLEMENTARY INFORMATION section of this notice. FOR FURTHER INFORMATION CONTACT: For information on the public comment period, contact the Office of Environmental Information Docket; telephone: 202–566–1752; facsimile: 202–566–1753; or e-mail: ORD.Docket@epa.gov. For technical information, please contact Resha M. Putzrath, Risk Assessment Forum; telephone: 202– 564–3229; facsimile: 202-565–0062; or e-mail: putzrath.resha@epa.gov. SUPPLEMENTARY INFORMATION: I. Information About the Document The Agency endorses a hierarchy of approaches to derive human equivalent oral exposures from data from laboratory animals, with the preferred approach being physiologically based toxicokinetic modeling. Intermediate approaches include using some chemical-specific information. In lieu of data to support either of these PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 approaches, body weight scaling to the 3/4 power (BW3⁄4) would be endorsed as a general default procedure to extrapolate toxicologically equivalent doses of chronic orally administered agents from laboratory animals to humans for the purpose of deriving an oral Reference Dose (RfD). Use of BW3⁄4 in derivation of RfD values would be parallel with current Agency use in derivation of cancer oral slope factors. Thus, this paper would harmonize the two main Agency oral dose-response extrapolation procedures. This generalized default procedure is viewed as an informed, species-specific, dosimetric adjustment factor (DAF) that addresses predominantly toxicokinetic and some toxicodynamic aspects of the interspecies uncertainty factor UFA. Use of this procedure would result in derivation of a human equivalent exposure, specifically a human equivalent dose (HED) that is to be used in derivation of the oral RfD in a manner parallel to the human equivalent concentration (HEC) in derivation of an inhalation RfC. II. How to Submit Technical Comments to the Docket Submit your comments, identified by Docket ID No. EPA–HQ–ORD 2006– 0116, by one of the following methods: • https://www.regulations.gov: Follow the on-line instructions for submitting comments. • E-mail: ORD.Docket@epa.gov. • Fax: 202–566–1753. • Mail: Office of Environmental Information Docket (Mail Code: 28221T), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202–566–1752; facsimile: 202–566–1753. If you provide comments in writing, please submit one unbound original with pages numbered consecutively, and three copies of the comments. For attachments, provide an index, number pages consecutively with the comments, and submit an unbound original and three copies. • Hand delivery/courier: The Office of Environmental Information (OEI) Docket is located in the Headquarters EPA Docket Center (EPA/DC), EPA West Building, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center 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 OEI Docket is 202–566–1752; facsimile: 202566-1753; or e-mail: ORD.Docket@epa.gov. Such deliveries E:\FR\FM\15FEN1.SGM 15FEN1 cprice-sewell on PROD1PC66 with NOTICES Federal Register / Vol. 71, No. 31 / Wednesday, February 15, 2006 / Notices are only accepted during the Docket’s normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to Docket ID No. EPA–HQ–ORD–2006– 0116. 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 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. For additional information about EPA’s public docket visit the EPA Docket Center home page at https:// www.epa.gov/epahome/dockets.htm. 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 Office of Environmental Information (OEI) Docket (EPA/DC), EPA West Building, Room B102, 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 VerDate Aug<31>2005 13:17 Feb 14, 2006 Jkt 208001 202–566–1744, and the telephone number for the OEI Docket is 202–566– 1752; facsimile 202-566–1753. Dated: February 7, 2006 Peter W. Preuss, Director, National Center for Environmental Assessment. [FR Doc. E6–2146 Filed 2–14–06; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–8031–7] Notice of Proposed Administrative Settlement Pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act Environmental Protection Agency (EPA). ACTION: Notice; request for public comment. AGENCY: SUMMARY: In accordance with section 122(h)(1) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (‘‘CERCLA’’), 42 U.S.C. 6922(h)(1), notice is hereby given of a proposed administrative settlement concerning the Union Creosoting Superfund Site (Site). The Site is located on approximately four acres of land adjacent to Parish Road 5404 in Farmerville, Union Parish, Louisiana. The geographic center of the site is located at Latitude 32°43′44″ North and Longitude 92°25′42″ West as scaled from the United States Geological Survey (USGS). The settlement requires the Settling Party, Mr. Jack W. Clampit to pay a total of $13,688.00 for reimbursement of past response costs to the EPA Hazardous Substance Superfund. The settlement includes a covenant not to sue which includes, but is not limited to: (1) Any direct or indirect claim for reimbursement from the EPA Hazardous Substance Superfund pursuant to sections 106(b)(2), 107, 111, 112, and 113 of CERCLA, 42 U.S.C. 9606(b)(2), 9607, 9611, 9612, or 9613; (2) any claims arising out of the response actions at or in connection with the Site; and (3) any claims against the United States pursuant to sections 107 and 113 of CERCLA, 42 U.S.C. 9607 and 9613, relating to the Site. For thirty (30) days following the date of publication of this notice, the Agency will receive written comments relating to the settlement. The Agency will consider all comments received and may modify or withdraw its consent to PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 7959 the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency’s response to any comments received will be available for public inspection at 1445 Ross Avenue, Dallas, Texas 75202–2733. DATES: Comments must be submitted on or before March 17, 2006. ADDRESSES: The proposed settlement and additional background information relating to the settlement are available for public inspection at 1445 Ross Avenue, Dallas, Texas 75202–2733. A copy of the proposed settlement may be obtained from Kenneth Talton, 1445 Ross Avenue, Dallas, Texas 75202–2733 at (214) 665–7475. Comments should reference the Union Creosoting Superfund Site, Farmerville, Louisiana, EPA Docket Number 06–01–05 and should be addressed to Kenneth Talton at the address listed above. FOR FURTHER INFORMATION CONTACT: Joseph Compton, 1445 Ross Avenue, Dallas, Texas 75202–2733 at (214) 665– 8506. Dated: February 3, 2006. Lawrence E. Starfield, Deputy Regional Administrator, Region 6. [FR Doc. E6–2143 Filed 2–14–06; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPPT–2006–0106; FRL–7763–6] Certain New Chemicals; Receipt and Status Information Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: Section 5 of the Toxic Substances Control Act (TSCA) requires any person who intends to manufacture (defined by statute to include import) a new chemical (i.e., a chemical not on the TSCA Inventory) to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. Under sections 5(d)(2) and 5(d)(3) of TSCA, EPA is required to publish a notice of receipt of a premanufacture notice (PMN) or an application for a test marketing exemption (TME), and to publish periodic status reports on the chemicals under review and the receipt of notices of commencement to manufacture those chemicals. This status report, which covers the period from January 16, 2006 to January 31, 2006, consists of the PMNs pending or expired, and the notices of commencement to E:\FR\FM\15FEN1.SGM 15FEN1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 31 (Wednesday, February 15, 2006)]
[Notices]
[Pages 7958-7959]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-2146]


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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-8031-9; EPA-HQ-Docket ID No. ORD-2006-0116]


Harmonization in Interspecies Extrapolation: Use of BW\3/4\ as 
Default Method in Derivation of the Oral RfD

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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

SUMMARY: EPA is announcing a 60-day public comment period for the draft 
document titled, ``Harmonization in Interspecies Extrapolation: Use of 
BW\3/4\ as Default Method in Derivation of the Oral RfD'' (EPA/630/R-
06/001), which was prepared by the EPA's Risk Assessment Forum (Forum).
    EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality 
guidelines. This document has not been formally disseminated by EPA. It 
does not represent and should not be construed to represent any Agency 
policy or determination. EPA will consider any public comments 
submitted in accordance with this notice when revising the document.

DATES: The 60-day public comment period begins February 15, 2006, and 
ends April 17, 2006. Technical comments should be in writing and must 
be received by EPA by April 17, 2006.

ADDRESSES: The draft, ``Harmonization in Interspecies Extrapolation: 
Use of BW\3/4\ as Default Method in Derivation of the Oral RfD,'' is 
available primarily via the Internet on the Risk Assessment Forum's 
home page at https://cfpub.epa.gov/ncea/raf/index.cfm. A limited number 
of paper copies are available from the Technical Information Staff, 
NCEA-W; telephone: 202-564-3261; facsimile: 202-565-0050. If you are 
requesting a paper copy, please provide your name, your mailing 
address, and the document title, ``Harmonization in Interspecies 
Extrapolation: Use of BW\3/4\ as Default Method in Derivation of the 
Oral RfD.''
    Comments may be submitted electronically, by mail, by facsimile, or 
by hand delivery/courier. Please follow the detailed instructions 
provided in the SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the public comment 
period, contact the Office of Environmental Information Docket; 
telephone: 202-566-1752; facsimile: 202-566-1753; or e-mail: 
ORD.Docket@epa.gov.
    For technical information, please contact Resha M. Putzrath, Risk 
Assessment Forum; telephone: 202-564-3229; facsimile: 202-565-0062; or 
e-mail: putzrath.resha@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Information About the Document

    The Agency endorses a hierarchy of approaches to derive human 
equivalent oral exposures from data from laboratory animals, with the 
preferred approach being physiologically based toxicokinetic modeling. 
Intermediate approaches include using some chemical-specific 
information. In lieu of data to support either of these approaches, 
body weight scaling to the 3/4 power (BW\3/4\) would be endorsed as a 
general default procedure to extrapolate toxicologically equivalent 
doses of chronic orally administered agents from laboratory animals to 
humans for the purpose of deriving an oral Reference Dose (RfD). Use of 
BW\3/4\ in derivation of RfD values would be parallel with current 
Agency use in derivation of cancer oral slope factors. Thus, this paper 
would harmonize the two main Agency oral dose-response extrapolation 
procedures. This generalized default procedure is viewed as an 
informed, species-specific, dosimetric adjustment factor (DAF) that 
addresses predominantly toxicokinetic and some toxicodynamic aspects of 
the interspecies uncertainty factor UFA. Use of this 
procedure would result in derivation of a human equivalent exposure, 
specifically a human equivalent dose (HED) that is to be used in 
derivation of the oral RfD in a manner parallel to the human equivalent 
concentration (HEC) in derivation of an inhalation RfC.

II. How to Submit Technical Comments to the Docket

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD 2006-
0116, by one of the following methods:
     https://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
     E-mail: ORD.Docket@epa.gov.
     Fax: 202-566-1753.
     Mail: Office of Environmental Information Docket (Mail 
Code: 28221T), U.S. Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460. The phone number is 202-566-1752; 
facsimile: 202-566-1753.
    If you provide comments in writing, please submit one unbound 
original with pages numbered consecutively, and three copies of the 
comments. For attachments, provide an index, number pages consecutively 
with the comments, and submit an unbound original and three copies.
     Hand delivery/courier: The Office of Environmental 
Information (OEI) Docket is located in the Headquarters EPA Docket 
Center (EPA/DC), EPA West Building, Room B102, 1301 Constitution Ave., 
NW., Washington, DC. The EPA Docket Center 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 OEI Docket is 202-566-1752; 
facsimile: 202-566-1753; or e-mail: ORD.Docket@epa.gov. Such deliveries

[[Page 7959]]

are only accepted during the Docket's normal hours of operation, and 
special arrangements should be made for deliveries of boxed 
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2006-0116. 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 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. For additional information about EPA's public 
docket visit the EPA Docket Center home page at https://www.epa.gov/
epahome/dockets.htm.
    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 Office of 
Environmental Information (OEI) Docket (EPA/DC), EPA West Building, 
Room B102, 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 number for the OEI 
Docket is 202-566-1752; facsimile 202-566-1753.

    Dated: February 7, 2006
Peter W. Preuss,
Director, National Center for Environmental Assessment.
 [FR Doc. E6-2146 Filed 2-14-06; 8:45 am]
BILLING CODE 6560-50-P

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