Harmonization in Interspecies Extrapolation: Use of BW3/4, 29623-29624 [E6-7836]

Download as PDF Federal Register / Vol. 71, No. 99 / Tuesday, May 23, 2006 / Notices rmajette on PROD1PC67 with NOTICES regulations.11 The CARB regulations set emission standards for these engines commencing with model year 2001 for certification and with model year 2004 for in-use compliance. There are two sets of standards depending on the size of the engine; one set for LSI engines less than or equal to 1.0 liters displacement, and the other for LSI engines greater than 1.0 liters displacement. For the smaller LSI engines, CARB set standards for HC plus Nox and for CO at static levels for model year 2002 and beyond, and 100% of a manufacturer’s sales must meet the standards each year. For the larger LSI engines, CARB approved two tiers of emission levels. For Tier 1, manufacturers are able to phase-in compliance at certification with 25% of the sales for 2001, 50% for 2003, and 75% for 2003, and manufacturers have no in-use compliance requirement. For Tier 2, beginning with the 2004 model year, manufacturers have to meet the standards at certification with 100% of sales, and are subject to in-use compliance with a less stringent standards for model years 2004 through 2006 (with an engine durability period of 3500 hours or 5 years) and full in-use standards for model years 2007 and beyond (with a durability period of 5000 hours or 7 years). To accompany the new standards, CARB also adopted regulations requiring manufacturer production line testing (along with CARB authority to conduct Selective Enforcement Audits), manufacturer required in-use testing, an in-use emission credit program, permanent emission labels, and emission warranties. CARB also adopted provisions to provide relief to small volume manufacturers (annual production under 2000 engines) basically by delaying the time when they must comply with in-use standards until 2004. EPA offered the opportunity for a public hearing, and requested public comments, on the CARB authorization request, as the Act requires us to do, by publication of a Federal Register notice to such effect on January 12, 2005.12 There was no request for a public hearing, nor were any comments received on the CARB authorization 11 These engines are often derived from automobile engines, although they have less sophisticated fuel and emission control systems, and are fueled usually by either gasoline or liquified petroleum gas (LPG). Typical applications for these LSI engines are forklifts, portable generators, large turf care equipment, irrigation pumps, welders, air compressors, scrubber/ sweepers, and airport service vehicles. CARB Initial Staff Report, Docket Entry OAR–2004–0404–0008, p1. 12 70 FR 2151 (January 12, 2005). VerDate Aug<31>2005 15:14 May 22, 2006 Jkt 208001 request. Therefore, EPA has made this determination based on the information submitted by CARB in its request. (C) Authorization Decision EPA has decided to grant California authorization to enforce its regulations setting emission standards and other requirements for large off-road sparkignition engines. In its request letter, CARB stated that these LSI regulations will not cause the California nonroad standards, in the aggregate, to be less protective of public health and welfare than the applicable Federal standards. CARB also stated that California’s need for the emission reductions expected from the LSI regulations remains compelling. Finally, regarding consistency with section 209, CARB stated that the LSI regulations (1) apply only to nonroad engines and vehicles and not to motor vehicles or engines, (2) apply only to those nonroad engines and vehicles which are not included in the preempted categories, and (3) do not raise any concerns of inadequate leadtime or technological feasibility or impose any certification requirements inconsistent with Federal requirements. EPA agrees with all CARB findings with regard to the provisions listed. Additionally, no information was presented to EPA by any party which would demonstrate that California did not meet the burden of satisfying the statutory criteria of section 209(e). For these reasons, EPA authorizes California to enforce these LSI regulations. My decision will affect not only persons in California but also the manufacturers outside the State who must comply with California’s requirements in order to produce nonroad engines and vehicles for sale in California. For this reason, I hereby determine and find that this is a final action of national applicability. Under section 307(b)(1) of the Act, judicial review of this final action may be sought only in the United States Court of Appeals for the District of Columbia Circuit. Petitions for review must be filed by July 24, 2006. Under section 307(b)(2) of the Act, judicial review of this final action may not be obtained in subsequent enforcement proceedings. As with past authorization decisions, this action is not a rule as defined by Executive Order 12866. Therefore, it is exempt from review by the Office of Management and Budget as required for rules and regulations by Executive Order 12866. In addition, this action is not a rule as defined in the Regulatory Flexibility Act, 5 U.S.C. 601(2). Therefore, EPA has not prepared a supporting regulatory PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 29623 flexibility analysis addressing the impact of this action on small business entities. The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, does not apply because this action is not a rule, for purposes of 5 U.S.C. 804(3). Finally, the Administrator has delegated the authority to make determinations regarding authorizations under section 209(e) of the Act to the Assistant Administrator for Air and Radiation. Dated: May 15, 2006. William L. Wehrum, Acting Assistant Administrator for Air and Radiation. [FR Doc. E6–7834 Filed 5–22–06; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–8173–5; Docket I.D. No. EPA–HQ– ORD–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 Peer-Review Teleconference with opportunity for public comment. AGENCY: SUMMARY: EPA is announcing that Versar, Inc., an EPA contractor for external scientific peer review, plans to convene an independent panel of experts and organize and conduct an external peer review meeting to review the draft document titled, ‘‘Harmonization in Interspecies Extrapolation: Use of BW3/4 as Default Method in Derivation of the Oral RfD’’ (EPA/630/R–06/001). The peer review meeting is planned to take place by teleconference. On Februrary 15, 2006, EPA announced a 60-day public comment period for the draft document (71 FR 7958). The draft document was prepared by the Agency’s Risk Assessment Forum. The public comment period and the external peer review are separate processes that provide opportunities for all interested parties to comment on the document. In addition to considering public comments submitted in accordance with the February 15, 2006, announcement of a public comment period, EPA intends to forward those comments to Versar, Inc. for the external peer review panel prior to the teleconference. E:\FR\FM\23MYN1.SGM 23MYN1 rmajette on PROD1PC67 with NOTICES 29624 Federal Register / Vol. 71, No. 99 / Tuesday, May 23, 2006 / Notices 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. The public will be given an opportunity to observe and provide oral comments at this teleconference by registering with Versar, Inc. (see FOR FURTHER INFORMATION CONTACT, below). The draft document and the charge questions for EPA’s external peer review are available primarily via the Internet on the Risk Assessment Forum’s home page under the External Review Drafts menu at https://cfpub.epa.gov/ncea/raf/ index.cfm. In preparing a final report, EPA will consider Versar Inc.’s report of the comments and recommendations from the external peer review meeting and any public comments that EPA receives in accordance with the February 15, 2006, notice (71 FR 7958). DATES: The peer review teleconference will be held on June 14, 2006, from 9 a.m. to no later than 5 p.m., with a break for lunch. The teleconference may end earlier than 5 p.m. if less time is needed for the reviewers to complete their discussion. Time will be provided for public observers who wish to make comments on the document. 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 under the External Review Drafts menu at https:// cfpub.epa.gov/ncea/raf/index.cfm. A limited number of paper copies are available from the Technical Information Staff, NCEA–W by telephone: 202–564–3261 or by facsimile: 202–565–0050. If you are requesting a paper copy, please provide your name, mailing address, and the document title, ‘‘Harmonization in Interspecies Extrapolation: Use of BW3/4 as Default Method in Derivation of the Oral RfD.’’ Copies are not available from Versar, Inc. FOR FURTHER INFORMATION CONTACT: Members of the public may call into the teleconference as observers, and there will be a limited time for comments from the public. In order to participate, you should contact Mr. Andrew Oravetz of Versar, Inc. at aoravetz@versar.com or by phone at 703–642–6832 to register. You will be asked for your name, affiliation, city and state, and contact information. When registering, please also indicate whether you would like to VerDate Aug<31>2005 15:14 May 22, 2006 Jkt 208001 make a statement during the call. Time for public comments is limited, and reservations will be accepted on a firstcome, first-served basis. At a time before June 14, 2006, registrants will be given the call-in information for the peer review teleconference. 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 (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 purposes 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. Dated: May 15, 2006. George Alapas, Deputy Director, National Center for Environmental Assessment. [FR Doc. E6–7836 Filed 5–22–06; 8:45 am] BILLING CODE 6560–50–P PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–ORD–2006–0187; FRL–8173–1] Human Studies Review Board (HSRB); Notification of a Public Teleconference To Review Its Draft Report From the April 4–6, 2006 HSRB Meeting Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: The EPA Human Studies Review Board (HSRB) announces a public teleconference meeting to discuss its draft HSRB report from the April 4– 6, 2006 HSRB meeting. DATES: The date for the teleconference will be held on June 8, 2006, from 1:30– 4 p.m. (Eastern Time). Location: The meeting will take place via telephone only. Meeting Access: For information on access or services for individuals with disabilities, please contact the DFO at least 10 business days prior to the meeting using the information under FOR FURTHER INFORMATION CONTACT so that appropriate arrangements can be made. Procedures for Providing Public Input: Interested members of the public may submit relevant written or oral comments for the HSRB to consider during the advisory process. Additional information concerning submission of relevant written or oral comments is provided in Unit I.D. of this notice. FOR FURTHER INFORMATION CONTACT: Members of the public who wish to obtain the call-in number and access code to participate in the telephone conference, request a current draft copy of the Board’s report or who wish further information may contact Paul I. Lewis, Designated Federal Officer (DFO), EPA, Office of the Science Advisory, (8105), Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; or via telephone/voice mail at (202) 564–8381 or via e-mail at lewis.paul@epa.gov. General information concerning the EPA HSRB can be on the EPA Web site at https:// www.epa.gov/osa/hsrb/. ADDRESSES: Submit your written comments, identified by Docket ID No. EPA–HQ–ORD–2006–0187, by one of the following methods: https:// 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. E:\FR\FM\23MYN1.SGM 23MYN1

Agencies

[Federal Register Volume 71, Number 99 (Tuesday, May 23, 2006)]
[Notices]
[Pages 29623-29624]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-7836]


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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-8173-5; Docket I.D. No. EPA-HQ-ORD-0116]


Harmonization in Interspecies Extrapolation: Use of 
BW3/4 as Default Method in Derivation of the Oral RfD

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Peer-Review Teleconference with opportunity for 
public comment.

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

SUMMARY: EPA is announcing that Versar, Inc., an EPA contractor for 
external scientific peer review, plans to convene an independent panel 
of experts and organize and conduct an external peer review meeting to 
review the draft document titled, ``Harmonization in Interspecies 
Extrapolation: Use of BW3/4 as Default Method in Derivation 
of the Oral RfD'' (EPA/630/R-06/001). The peer review meeting is 
planned to take place by teleconference. On Februrary 15, 2006, EPA 
announced a 60-day public comment period for the draft document (71 FR 
7958). The draft document was prepared by the Agency's Risk Assessment 
Forum.
    The public comment period and the external peer review are separate 
processes that provide opportunities for all interested parties to 
comment on the document. In addition to considering public comments 
submitted in accordance with the February 15, 2006, announcement of a 
public comment period, EPA intends to forward those comments to Versar, 
Inc. for the external peer review panel prior to the teleconference.

[[Page 29624]]

    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.
    The public will be given an opportunity to observe and provide oral 
comments at this teleconference by registering with Versar, Inc. (see 
FOR FURTHER INFORMATION CONTACT, below). The draft document and the 
charge questions for EPA's external peer review are available primarily 
via the Internet on the Risk Assessment Forum's home page under the 
External Review Drafts menu at https://cfpub.epa.gov/ncea/raf/index.cfm. 
In preparing a final report, EPA will consider Versar Inc.'s report of 
the comments and recommendations from the external peer review meeting 
and any public comments that EPA receives in accordance with the 
February 15, 2006, notice (71 FR 7958).

DATES: The peer review teleconference will be held on June 14, 2006, 
from 9 a.m. to no later than 5 p.m., with a break for lunch. The 
teleconference may end earlier than 5 p.m. if less time is needed for 
the reviewers to complete their discussion. Time will be provided for 
public observers who wish to make comments on the document.

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 under the External Review Drafts menu at https://
cfpub.epa.gov/ncea/raf/index.cfm. A limited number of paper copies 
are available from the Technical Information Staff, NCEA-W by 
telephone: 202-564-3261 or by facsimile: 202-565-0050. If you are 
requesting a paper copy, please provide your name, mailing address, and 
the document title, ``Harmonization in Interspecies Extrapolation: Use 
of BW3/4 as Default Method in Derivation of the Oral RfD.'' 
Copies are not available from Versar, Inc.

FOR FURTHER INFORMATION CONTACT: Members of the public may call into 
the teleconference as observers, and there will be a limited time for 
comments from the public. In order to participate, you should contact 
Mr. Andrew Oravetz of Versar, Inc. at aoravetz@versar.com or by phone 
at 703-642-6832 to register. You will be asked for your name, 
affiliation, city and state, and contact information. When registering, 
please also indicate whether you would like to make a statement during 
the call. Time for public comments is limited, and reservations will be 
accepted on a first-come, first-served basis. At a time before June 14, 
2006, registrants will be given the call-in information for the peer 
review teleconference.
    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 (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 purposes 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.

    Dated: May 15, 2006.
George Alapas,
Deputy Director, National Center for Environmental Assessment.
[FR Doc. E6-7836 Filed 5-22-06; 8:45 am]
BILLING CODE 6560-50-P
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