Notice of Availability; Recommended Use of Body Weight3∕4 as the Default Method in Derivation of the Oral Reference Dose, 10591-10592 [2011-4250]

Download as PDF Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices accommodate this need and allow registrants time to develop replacement products. The current temephos products would not be cancelled until December 30, 2015. For these reasons, the Agency does not believe that the comment period should be extended. IV. Cancellation Order Pursuant to FIFRA section 6(f), EPA hereby approves the requested cancellations of the registrations identified in Tables 1, 2, and 3 of Unit II. Accordingly, the Agency hereby orders that the product registrations identified in Tables 1, 2, and 3 of Unit II. are cancelled. The effective date of the cancellation of the products listed in Tables 1 and 3 of this notice is February 25, 2011. The effective date of the cancellation of the products listed in Table 2 is December 31, 2015. Any distribution, sale, or use of existing stocks of the products identified in Tables 1, 2, and 3 of Unit II. in a manner inconsistent with any of the provisions for disposition of existing stocks set forth in Unit VI. will be a violation of FIFRA. srobinson on DSKHWCL6B1PROD with NOTICES V. What is the agency’s authority for taking this action? Section 6(f)(1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register. Thereafter, following the public comment period, the EPA Administrator may approve such a request. The notices of receipt for this action were published for comment in the Federal Register issues of November 10, 2010 (75 FR 69073) (FRL– 8851–5) and November 17, 2010 (75 FR 70256) (FRL–8850–1). The comment periods closed on December 10, 2010 and December 17, 2010 respectively. VI. Provisions for Disposition of Existing Stocks Existing stocks are those stocks of registered pesticide products which are currently in the United States and which were packaged, labeled, and released for shipment prior to the effective date of the cancellation action. The existing stocks provisions for the products subject to this order are as follows. A. For All Products Listed in Table 1 of Unit II The registrants may continue to sell and distribute existing stocks of products listed in Table 1 of Unit II. VerDate Mar<15>2010 16:39 Feb 24, 2011 Jkt 223001 until February 25, 2012, which is 1 year after the publication of the Cancellation Order in the Federal Register. Thereafter, the registrants are prohibited from selling or distributing products listed in Table 1, except for export in accordance with FIFRA section 17, or proper disposal. Persons other than the registrants may sell, distribute, or use existing stocks of products listed in Table 1 of Unit II. until existing stocks are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled products. B. For All Products Listed in Table 2 of Unit II After December 31, 2015, registrants are prohibited from selling or distributing existing stocks of products containing temephos labeled for all uses. After December 31, 2016, persons other than registrants are prohibited from selling or distributing existing stocks of products containing temephos labeled for all uses. After December 31, 2016, existing stocks of products containing temephos labeled for all uses, already in the hands of users can be used legally until they are exhausted, provided that such use complies with the EPA-approved label and labeling of the affected product. C. For All Products Listed in Table 3 of Unit II All sale or distribution by the registrant of existing stocks is prohibited after publication of the cancellation order in the Federal Register, unless that sale or distribution is solely for the purpose of facilitating disposal or export of the product. Existing stocks may be sold and distributed by persons other than the registrant for 120 days from the effective date of the cancellation order. Existing stocks may be used until exhausted, provided that such use complies with the EPA-approved label and labeling of the product. List of Subjects Dated: February 8, 2011. Richard P. Keigwin, Jr., Director, Pesticide Re-evaluation Division, Office of Pesticide Programs. [FR Doc. 2011–4140 Filed 2–24–11; 8:45 am] BILLING CODE 6560–50–P PO 00000 Frm 00037 Fmt 4703 ENVIRONMENTAL PROTECTION AGENCY [EPA/100/R–11/001; FRL–9270–7] Notice of Availability; Recommended Use of Body Weight3⁄4 as the Default Method in Derivation of the Oral Reference Dose Environmental Protection Agency (EPA). ACTION: Notice of availability. AGENCY: This notice announces the availability of ‘‘Recommended Use of Body Weight3/4 as the Default Method in Derivation of the Oral Reference Dose’’ (referred to hereafter as BW3/4). This document was developed as part of an Agency-wide guidance development program by a technical panel of the U.S. EPA’s Risk Assessment Forum, composed of scientists from across the Agency. Selected drafts were peer reviewed internally by EPA scientists and externally by experts from academia, industry, environmental groups and other government agencies. DATES: The document will be available for use by EPA risk assessors on February 25, 2011. ADDRESSES: The Guidelines are available electronically through the EPA Web site at https://www.epa.gov/raf/ publications/interspeciesextrapolation.htm. A limited number of paper copies will be available from EPA’s National Service Center for Environmental Publications (NSCEP), P.O. Box 42419, Cincinnati, OH 45242; telephone (800) 490–9198 or (513) 489– 8695; facsimile: (513) 489–8190. Please provide your name, mailing address and the title and number of the requested publication. Additionally, copies of the document will be available for inspection at EPA headquarters and regional libraries, through the U.S. Government Depository Library program. SUMMARY: Dr. Michael W. Broder, Risk Assessment Forum, Office of the Science Advisor (8105R), U.S. Environmental Protection Agency, Washington, DC 20460; telephone (202) 564–3393 or e-mail: broder.michael@epa.gov. FOR FURTHER INFORMATION CONTACT: In order to assess the toxicity of a particular chemical in the absence of human data, EPA relies on the use of animal models as surrogates. EPA endorses a hierarchy of approaches to derive human equivalent oral exposures from data from laboratory animal species, with the preferred approach being physiologically based toxicokinetic SUPPLEMENTARY INFORMATION: Environmental protection, Pesticides and pests. Sfmt 4703 10591 E:\FR\FM\25FEN1.SGM 25FEN1 srobinson on DSKHWCL6B1PROD with NOTICES 10592 Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices modeling. As a default method to account for differences in dosimetry between the animal models and humans, EPA previously applied a direct body-weight conversion from the model to humans (i.e., BW1/1) for noncancer endpoints, in the absence of chemical-specific data. In contrast, EPA applies a dosimetric adjustment factor (DAF) based on body weight raised to the three-quarter power (BW3/4) for cancer assessments. By adopting the adjustment, this document moves in the direction of harmonizing the approach for assessing cancer and noncancer endpoints. In addition to laying out the computational method for interspecies extrapolation, the document also addresses the issue of changes to the interspecies uncertainty factor (UFA). The document recommends a reduced interspecies UFA (with a default value of 3) in lieu of a default of 10 for the reference dose (RfD) calculation. The quantitative significance of this procedure with regard to the magnitude of an RfD will depend on the body weight of the species (as well as the value assigned to the UFA) and may be more or less than the current procedure of dividing by the default composite UFA of 10. BW3/4 scaling for derivation of the human equivalent dose is recommended as the default approach for RfDs for remote, as well as portal-of-entry effects. It is noted that this scaling is not inclusive of lethal or frank effects for which maximum concentration (Cmax) may be the most appropriate dose metric and that such effects are not among those effects recommended for use in deriving RfDs (USEPA, 2002). This default approach generally applies to different durations of exposure. The reader is encouraged to read the document carefully, however, in order to fully understand how to apply the policy appropriately. Additionally, although non-oral RfDs can be estimated (e.g., a dermal RfD), this document focuses only on oral RfDs and for this document the acronym refers only to RfDs for oral exposure. It is recognized that this procedure, as with all default procedures, may not always predict oral exposures associated with precise toxicologically-equivalent doses for specific chemicals. It should be emphasized that other biological information not discussed in this document may inform interspecies adjustments. As a general default procedure, however, it may be anticipated to provide a reasonable description of average behavior of many chemicals much of the time. VerDate Mar<15>2010 16:39 Feb 24, 2011 Jkt 223001 Even though this document is not a binding rule, EPA is issuing it in a manner consistent with the procedures in the Administrative Procedure Act that are generally applicable to rulemaking, including providing opportunity for public comment. EPA considered and responded to all significant public comments as it prepared the document. Dated: February 16, 2011. Paul T. Anastas, EPA Science Advisor. difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible. ADDRESSES: Direct all PRA comments to the Federal Communications Commission via e-mail to PRA@fcc.gov. FOR FURTHER INFORMATION CONTACT: Judith B. Herman, Office of Managing Director, (202) 418–0214. For additional information, contact Judith B. Herman, OMD, 202–418–0214 or e-mail judithb.herman@fcc.gov. [FR Doc. 2011–4250 Filed 2–24–11; 8:45 am] SUPPLEMENTARY INFORMATION: BILLING CODE 6560–50–P OMB Control Number: 3060–1113. Title: Commercial Mobile Alert System (CMAS). Form No.: N/A. Type of Review: Revision of a currently approved collection. Respondents: Business or other forprofit. Number of Respondents and Responses: 1,253 respondents; 1,253 responses. Estimated Time per Response: .5 hours. Frequency of Response: On occasion reporting requirement, recordkeeping requirement and third party disclosure requirement. Obligation to Respond: Mandatory. Statutory authority for this information collection is contained in 47 U.S.C. 151, 154(i), 154(j), 154(o), 218, 219, 230, 256, 301, 302(a), 303(f), 303(g), 303(j), 303(r), 403, 621(b)(3), and 621(d). Total Annual Burden: 627 hours. Total Annual Cost: N/A. Privacy Act Impact Assessment: N/A. Nature and Extent of Confidentiality: There is no need for confidentiality. Needs and Uses: The Commission will submit this expiring information collection after this comment period to the Office of Management and Budget (OMB) to obtain the three year clearance from them. The Commission is reporting a 502 hour increase in the total annual burden. The Commission will submit this collection to the OMB as a revision. This information collection is being submitted because, in the Third Report and Order in PS Docket No. 07–287, FCC 08–184, the Commission adopted rules that require Commercial Mobile Service (CMS) providers to collect information subject to the Paperwork Reduction Act. In the Third Report and Order, the Commission adopted rules obligating entities participating in the Commercial Mobile Alert System (CMAS) to provide written election of intent to participate in the CMAS. All CMS providers are required to submit a CMAS election, including those that were not licensed at the time of the initial deadline for filing an FEDERAL COMMUNICATIONS COMMISSION Notice of Public Information Collection(s) Being Reviewed by the Federal Communications Commission, Comments Requested February 18, 2011. The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501— 3520. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission’s burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology, and (e) ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a currently valid OMB control number. DATES: Written Paperwork Reduction Act (PRA) comments should be submitted on or before April 26, 2011. If you anticipate that you will be submitting PRA comments, but find it SUMMARY: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1

Agencies

[Federal Register Volume 76, Number 38 (Friday, February 25, 2011)]
[Notices]
[Pages 10591-10592]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4250]


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

ENVIRONMENTAL PROTECTION AGENCY

[EPA/100/R-11/001; FRL-9270-7]


Notice of Availability; Recommended Use of Body 
Weight[bds3][bdsol][bds4] as the Default Method in Derivation of the 
Oral Reference Dose

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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

SUMMARY: This notice announces the availability of ``Recommended Use of 
Body Weight3/4 as the Default Method in Derivation of the 
Oral Reference Dose'' (referred to hereafter as BW3/4). This 
document was developed as part of an Agency-wide guidance development 
program by a technical panel of the U.S. EPA's Risk Assessment Forum, 
composed of scientists from across the Agency. Selected drafts were 
peer reviewed internally by EPA scientists and externally by experts 
from academia, industry, environmental groups and other government 
agencies.

DATES: The document will be available for use by EPA risk assessors on 
February 25, 2011.

ADDRESSES: The Guidelines are available electronically through the EPA 
Web site at https://www.epa.gov/raf/publications/interspecies-extrapolation.htm. A limited number of paper copies will be available 
from EPA's National Service Center for Environmental Publications 
(NSCEP), P.O. Box 42419, Cincinnati, OH 45242; telephone (800) 490-9198 
or (513) 489-8695; facsimile: (513) 489-8190. Please provide your name, 
mailing address and the title and number of the requested publication. 
Additionally, copies of the document will be available for inspection 
at EPA headquarters and regional libraries, through the U.S. Government 
Depository Library program.

FOR FURTHER INFORMATION CONTACT: Dr. Michael W. Broder, Risk Assessment 
Forum, Office of the Science Advisor (8105R), U.S. Environmental 
Protection Agency, Washington, DC 20460; telephone (202) 564-3393 or e-
mail: broder.michael@epa.gov.

SUPPLEMENTARY INFORMATION: In order to assess the toxicity of a 
particular chemical in the absence of human data, EPA relies on the use 
of animal models as surrogates. EPA endorses a hierarchy of approaches 
to derive human equivalent oral exposures from data from laboratory 
animal species, with the preferred approach being physiologically based 
toxicokinetic

[[Page 10592]]

modeling. As a default method to account for differences in dosimetry 
between the animal models and humans, EPA previously applied a direct 
body-weight conversion from the model to humans (i.e., 
BW1/1) for non-cancer endpoints, in the absence of chemical-
specific data. In contrast, EPA applies a dosimetric adjustment factor 
(DAF) based on body weight raised to the three-quarter power 
(BW3/4) for cancer assessments. By adopting the adjustment, 
this document moves in the direction of harmonizing the approach for 
assessing cancer and noncancer endpoints.
    In addition to laying out the computational method for interspecies 
extrapolation, the document also addresses the issue of changes to the 
interspecies uncertainty factor (UFA). The document 
recommends a reduced interspecies UFA (with a default value 
of 3) in lieu of a default of 10 for the reference dose (RfD) 
calculation. The quantitative significance of this procedure with 
regard to the magnitude of an RfD will depend on the body weight of the 
species (as well as the value assigned to the UFA) and may 
be more or less than the current procedure of dividing by the default 
composite UFA of 10.
    BW3/4 scaling for derivation of the human equivalent 
dose is recommended as the default approach for RfDs for remote, as 
well as portal-of-entry effects. It is noted that this scaling is not 
inclusive of lethal or frank effects for which maximum concentration 
(Cmax) may be the most appropriate dose metric and that such 
effects are not among those effects recommended for use in deriving 
RfDs (USEPA, 2002). This default approach generally applies to 
different durations of exposure. The reader is encouraged to read the 
document carefully, however, in order to fully understand how to apply 
the policy appropriately. Additionally, although non-oral RfDs can be 
estimated (e.g., a dermal RfD), this document focuses only on oral RfDs 
and for this document the acronym refers only to RfDs for oral 
exposure.
    It is recognized that this procedure, as with all default 
procedures, may not always predict oral exposures associated with 
precise toxicologically-equivalent doses for specific chemicals. It 
should be emphasized that other biological information not discussed in 
this document may inform interspecies adjustments. As a general default 
procedure, however, it may be anticipated to provide a reasonable 
description of average behavior of many chemicals much of the time.
    Even though this document is not a binding rule, EPA is issuing it 
in a manner consistent with the procedures in the Administrative 
Procedure Act that are generally applicable to rulemaking, including 
providing opportunity for public comment. EPA considered and responded 
to all significant public comments as it prepared the document.

    Dated: February 16, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-4250 Filed 2-24-11; 8:45 am]
BILLING CODE 6560-50-P
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