[Federal Register: March 25, 2009 (Volume 74, Number 56)]
[Notices]
[Page 12856-12858]
[DOCID:fr25mr09-98]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0045; FRL-8399-4]

Notice of Receipt of Several Pesticide Petitions Filed for
Residues of Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY:  This notice announces the Agency's receipt of several initial
filings of pesticide petitions proposing the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before April 24, 2009.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the docket ID number and the
pesticide petition number of interest as shown in the body of this
document. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://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 regulations.gov or e-
mail. The regulations.gov website 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 regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the 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 docket index
available at http://www.regulations.gov. 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, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: A contact person, with telephone
number and e-mail address, is listed at the end of each pesticide
petition summary. You may also reach each contact person by mail at:
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed at the end of the pesticide petition
summary of interest.

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.

    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What Action is the Agency Taking?

     EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, proposing the establishment or modification of
regulations in 40 CFR part 174 or part 180 for residues of pesticide
chemicals in or on various food commodities. EPA has determined that
the pesticide petitions described in this notice contain the data or
information prescribed in FFDCA section 408(d)(2); however, EPA has not
fully evaluated the sufficiency of the submitted data at this time or
whether the data support granting of the pesticide petitions.
Additional data may be needed before EPA can make a final determination
on these pesticide petitions.
     Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of this notice, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available on-line at http://
www.regulations.gov.
    As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)),
EPA is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.

New Tolerance

     1. PP 8F7451. (EPA-HQ-OPP-2009-0007). Cheminova, One Park Drive,
Research Triangle Park, NC 27707, proposes to establish a tolerance in
40 CFR part 180.364 for residues of the herbicide glyphosate N-
(phosphonomethyl) glycine resulting from the application of glyphosate,
the isopropylamine salt of glyphosate, the ethanolamine salt of
glyphosate, the dimethylamine salt of glyphosate, the ammonium salt of
glyphosate, and the potassium salt of glyphosate in or on cotton, gin
by-products at 210 parts per million (ppm). Adequate enforcement
methods are available for analysis of residues of glyphosate and its
metabolite AMPA in or on plant commodities and in water. These methods
include gas liquid chromatography (GLC) (Method I of PAM Vol. II; limit
of detection is 0.05 ppm) and high performance liquid chromatography
(HPLC) with fluorometric detection. Use of the GLC method, however, is
being discouraged due to lengthiness of the procedure. The HPLC method
has undergone successful EPA validation and was recommended for
inclusion in PAM Vol. II; the limit of detection is 0.0005 ppm. For
enforcement of tolerances in animal commodities, an HPLC method with
fluorescence detector is available; the reported limits of detection
are 0.01 ppm for glyphosate and 0.012 ppm for AMPA.'' Contact: Vickie
Walters,<PHONE_NUMBER><EMAIL_ADDRESS>
New Tolerance Exemption

     1. PP 8E7465. (EPA-HQ-OPP-2008-0888). The Joint Inerts Task Force,
Cluster Support Team 23, EPA Company Number 84951, c/o CropLife
America, 1156 15th Street, N.W., Suite 400, Washington, DC 20005,
proposes to establish an exemption from the requirement of a tolerance
for residues of Polyglyceryl Phthalate Ester of Coconut Fatty Acids
under 40 CFR Sec. 180.910, including Fatty acid coco polymers with
glycerol and phthalic anhydride (CAS No. 67746-02-5) and Coconut oil
polymer with glycerol and phthalic anhydride (CAS No. 66070-87-9) when
used as pesticide inert ingredients in pesticide formulations in or on
all raw agricultural commodities. Because this petition is a request
for an exemption from the requirement of a tolerance, no analytical
method is required. Contact: Kerry Leifer,<PHONE_NUMBER>,
<EMAIL_ADDRESS>     2. PP 8E7466. (EPA-HQ-OPP-2008-0890). The Joint Inerts Task Force,
Cluster Support Team 5, EPA Company Number 84941, c/o CropLife America,
1156 15th Street, N.W., Suite 400, Washington, DC 20005, proposes to
establish an exemption from the requirement of a tolerance for residues
of [alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]-hydroxypoly
(oxyethylene) produced by the condensation of 1 mole of p-(1,1,3,3-
tetramethylbutyl)phenol with a range of 1-14 or 30-70 moles of ethylene
oxide: if a blend of products is used, the average range number of
moles of ethylene oxide reacted to produce any product that is a
component of the blend shall be in the range of 1-14 or 30-70 under 40
CFR 180.910 including the following: Poly (oxy-1, 2-ethanediyl), alpha-
[4-(1,1,3,3-tetramethylbutyl)phenyl]-omega-hydroxy- (CAS No. 9036-19-5)
and Poly (oxy-1, 2-ethanediyl), alpha-[4-(1,1,3,3-
tetramethylbutyl)phenyl]-omega-hydroxy- (CAS No. 9002-93-1) when used
as pesticide inert ingredients in pesticide formulations. Because this
petition is a request for an exemption from the requirement of a
tolerance, no analytical method is required. Contact: Kerry Leifer,
703-308-8811<EMAIL_ADDRESS>     3. PP 8E7472. (EPA-HQ-OPP-2008-0889). The Joint Inerts Task Force,
Cluster Support Team 8, EPA Company Number 84942, c/o CropLife America,
1156 15th Street, N.W., Suite 400, Washington, DC 20005, proposes to
establish an exemption from the requirement of a tolerance for the
replacement descriptor for pre-harvest use on all agricultural crops
under 40 CFR Sec. 180.920 and when applied to animals under 40 CFR
Sec. 180.930 for the following amine salts of alkyl (C8-C24)
benzenesulfonic acid (dimethylaminopropylamine, isopropylamine, mono-,
di-, and triethanolamine), including CAS Reg Nos. 68953-97-9, 26545-53-
9, 877677-48-0, 319926-68-6, 90194-53-9, 55470-69-4, 68910-32-7, 26264-
05-1, 157966-96-6, 68584-24-7, 68648-81-7, 68649-00-3, 68953-93-5,
90218-35-2, 27323-41-7, 68584-25-8, 68648-96-4, 68411-31-4, 90194-42-6
and 1093628-27-3. Prior to the submission of this petition, a data
development plan was submitted to the Agency and subsequently it was
agreed Joint Inerts

Task Force, Cluster Support Team 8 that additional data be generated on
CAS RN 26264-05-1. Because this petition is a request for an exemption
from the requirement of a tolerance, no analytical method is required.
Contact: Kerry Leifer,<PHONE_NUMBER><EMAIL_ADDRESS>     4. PP 8E7478. (EPA-HQ-OPP-2008-0892). The Joint Inerts Task Force,
Cluster Support Team 9, EPA Company Number 84943, c/o CropLife America,
1156 15th Street, N.W., Suite 400, Washington, DC 20005, proposes to
establish an exemption from the requirement of a tolerance for residues
of Nonylphenol Ethoxylate (NPE) Phosphate and Sulfate Derivatives pre-
and post-harvest (40 CFR 180.910) and animal uses (40 CFR 180.930) in
or on all raw agricultural commodities when used as pesticide inert
ingredients in pesticide formulations, including 40 CFR Sec. 180.910
and 40 CFR Sec. 180.930: [alpha]-(p-Nonylphenyl)-[omega]-
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and mono
hydrogen phosphate esters and the corresponding ammonium, calcium,
magnesium, monoethanolamine, potassium, sodium, and zinc salts of the
phosphate esters; the nonyl group is a propylene trimer isomer and the
poly(oxyethylene) content averages 4-14 moles or 30 moles for CAS Reg.
Nos. 51811-79-1, 59139-23-0, 67922-57-0, 68412-53-3, 68553-97-9, 68954-
84-7, 99821-14-4, 152143-22-1, 51609-41-7, 37340-60-6, 106151-63-7,
68584-47-4, 52503-15-8, 68458-49-1; and 40 CFR 180.910 and 40 CFR
180.930: [alpha]-(p-Nonylphenyl)-[omega]- hydroxypoly(oxyethylene)
sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc
salts; the nonyl group is propylene trimer isomer and the
poly(oxyethylene) content averages 4 moles for CAS Reg Nos. 9014-90-8,
9051-57-4, 9081-17-8, 68649-55-8, 68891-33-8; and 40 CFR Sec. 180.930
[alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene) sulfate, and
its ammonium, calcium, magnesium, potassium, sodium, and zinc salts;
the nonyl group is a propylene trimer isomer and the poly(oxyethylene)
content averages 4-14 or 30-90 moles of ethylene oxide for CAS Reg Nos.
9014-90-8, 9051-57-4, 9081-17-8, 68649-55-8, 68891-33-8. Because this
petition is a request for an exemption from the requirement of a
tolerance, no analytical method is required. Contact: Kerry Leifer,
703-308-8811<EMAIL_ADDRESS>     5 PP 8E7494. (EPA-HQ-OPP-2008-0944). Joint Inerts Task Force,
Cluster Support Team 20, EPA Company Number 84950, c/o CropLife
America, 1156 15th Street, N.W., Suite 400, Washington, DC 20005,
proposes to establish an exemption from the requirement of a tolerance
for residues of Polyoxyethylene polyoxypropylene mono(di-sec-
butylphenyl) ether (CAS No. 69029-39-6), under 40 CFR 180.920, when
used as a pesticide inert ingredient in herbicide formulations. It is
proposed that the tolerance exemption is limited to use with pesticidal
formulations that are used as herbicides. Because this petition is a
request for an exemption from the requirement of a tolerance, no
analytical method is required. Contact: Kerry Leifer,<PHONE_NUMBER>,
<EMAIL_ADDRESS>     6 PP 8E7405. (EPA-HQ-OPP-2008-0822). Akzo Nobel Surface Chemistry,
LLC, 525 West Van Buren Street, Chicago, IL 60607-3823, proposes to
establish an exemption from the requirement of a tolerance in 40 CFR
180.920 for residues of mono-, di-, and trimethylnapthalendesulfonic
acids and naphthalenesulfonic acids formaldehyde condensates, ammonium
and sodium salts when used as a pesticide inert ingredient in pesticide
formulations. Because this petition is a request for an exemption from
the requirement of a tolerance, no analytical method is required.
Contact: Karen Samek,<PHONE_NUMBER><EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: March 12, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E9-6265 Filed 3-24-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: October 20, 2009 (Volume 74, Number 201)]
[Notices]
[Page 53753-53754]
[DOCID:fr20oc09-68]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0157] (Formerly Docket No. 2006D-0514)

Guidance for Industry: Minimally Manipulated, Unrelated
Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic
Reconstitution for Specified Indications; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a guidance document entitled ``Guidance for Industry:
Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord
Blood Intended for Hematopoietic Reconstitution for Specified
Indications,'' dated October 2009. In this guidance, we refer to these
products for hematopoietic reconstitution for specified indications as
hematopoietic progenitor cells, cord (HPC-C). This guidance (HPC-C
licensure guidance) provides recommendations to manufacturers applying
for licensure of minimally manipulated, unrelated allogeneic placental/
umbilical cord blood, for specified indications. Elsewhere in this
issue of the Federal Register, FDA is publishing a draft guidance
entitled ``Guidance for Industry and FDA Staff: Investigational New
Drug Applications (INDs) for Minimally Manipulated, Unrelated
Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic
Reconstitution for Specified Indications.'' FDA is also announcing the
end of the phased-in implementation period for IND and biologics
license application (BLA) requirements for minimally manipulated
unrelated allogeneic hematopoietic stem/progenitor cell products. The
HPC-C licensure guidance announced in this notice finalizes the draft
guidance entitled ``Guidance for Industry: Minimally Manipulated,
Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for
Hematopoietic Reconstitution in Patients with Hematological
Malignancies,'' dated December 2006.

DATES:  Submit electronic or written comments on agency guidances at
any time. FDA no longer intends to exercise enforcement discretion with
respect to IND and BLA requirements for minimally manipulated,
unrelated allogeneic hematopoietic stem/progenitor cell products and
the phase in implementation period for IND and BLA requirements will
end after October 20, 2011.

ADDRESSES:  Submit written requests for single copies of the guidance
to the Office of Communication, Outreach and Development (HFM-40),
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://
www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Tami Belouin, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance document entitled
``Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic
Placental/Umbilical Cord Blood Intended for Hematopoietic
Reconstitution for Specified Indications,'' dated October 2009. This
guidance provides recommendations to manufacturers applying for
licensure of minimally manipulated, unrelated allogeneic placental/
umbilical cord blood, for specified indications. Elsewhere in this
issue of the Federal Register, FDA is publishing an IND draft guidance
entitled ``Guidance for Industry and FDA Staff: Investigational New
Drug Applications (INDs) for Minimally Manipulated, Unrelated
Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic
Reconstitution for Specified Indications.'' FDA is also announcing that
it no longer intends to exercise enforcement discretion with respect to
IND and BLA requirements for minimally manipulated unrelated allogeneic
hematopoietic stem/progenitor cell products and the phase-in
implementation period for IND and license application requirements for
these products will end (see DATES for ending date). We encourage
sponsors to send in applications as soon as possible to allow
sufficient time for review, comment, and re-submission as needed to
complete all actions by the end of this 2-year period.
    In the Federal Register notice of January 20, 1998 (63 FR 2985),
FDA requested submission of comments proposing establishment controls,
process controls, and product standards designed to ensure the safety
and effectiveness of minimally manipulated unrelated allogeneic
hematopoietic stem/progenitor cell products derived from peripheral and
cord blood for hematopoietic reconstitution. Also, in the January 20,
1998, notice, FDA announced its intention to phase in implementation of
IND and license application requirements for minimally manipulated
unrelated allogeneic hematopoietic stem/progenitor cell products to
permit the development of licensing standards for those products where
possible.
    In the Federal Register notice of January 17, 2007 (72 FR 1999),
FDA announced the availability of the draft guidance entitled
``Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic
Placental/Umbilical Cord Blood Intended for Hematopoietic
Reconstitution in Patients with Hematological Malignancies,'' dated
December 2006. FDA received comments on the December 2006 draft
guidance and those comments were considered as the guidance was
finalized. The HPC-C licensure guidance announced in this notice
finalizes the December 2006 draft guidance. Some of the comments
received by FDA expressed the importance of access and availability of
HPC-C products that not do meet standards for licensure and therefore
cannot be licensed. FDA recognizes the importance of these products and
is publishing a draft IND guidance addressing IND submissions for such
products.
    This guidance is consistent with FDA's good guidance practices
regulation (21 CFR 10.115). The guidance represents FDA's current
thinking on these topics. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public.
Alternative approaches may be used if such approaches satisfy the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These

collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part
201 have been approved under OMB Control No. 0910-0572; 21 CFR part 211
have been approved under OMB Control No. 0910-0139; 21 CFR part 600
have been approved under OMB Control No. 0910-0308; 21 CFR parts 601,
610, and FDA Form 356(h) have been approved under OMB Control No. 0910-
0338; 21 CFR part 1271 have been approved under OMB Control Nos. 0910-
0559, 0910-0469, and 0910-0543; and FDA Form 3500A has been approved
under OMB Control No. 0910-0291.

III. Comments

    Interested persons may, at any time, submit to the Division of
Dockets Management (see ADDRESSES) electronic or written comments
regarding the guidance. Submit a single copy of electronic comments or
two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments are to be identified with the docket
number found in brackets in the heading of this document. A copy of the
guidance and received comments are available for public examination in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http:/
/www.regulations.gov.

    Dated: October 14, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25135 Filed 10-19-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 51978-51979]
[FR Doc No: 2022-18208]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2022-0449; FRL-10095-01-OAR]

Proposed Agency Information Collection Request; Comment Request;
GreenChill Advanced Refrigeration Partnership (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``GreenChill Advanced
Refrigeration Partnership (Renewal)'' (EPA ICR No. 2349.03, OMB Control
No. 2060-0702) to the Office of Management and Budget (OMB) for review
and approval in accordance with the Paperwork Reduction Act. Before
doing so, EPA is soliciting public comments on specific aspects of the
proposed information collection as described below. This is a proposed
extension of the ICR, which is currently approved through March 31,
2023. An Agency may not conduct or sponsor and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number.

DATES: Comments must be submitted on or before October 24, 2022.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2022-0449, online using www.regulations.gov (our preferred method), by
email to [email protected], or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Kersey Manliclic, Stratospheric
Protection Division--Office of Air and Radiation, (3204A),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: GreenChill is a voluntary partnership program sponsored
by the U.S. Environmental Protection Agency (EPA) that encourages food
retailers and manufacturers to adopt cost effective technologies and
practices that reduce refrigerant emissions and improve operational
efficiency. The GreenChill Program works with the food retail industry
to lower barriers inhibiting the implementation of technologies and
practices that reduce refrigerant emissions. The Program effectively
promotes the adoption of emission reduction practices and technologies
by engaging GreenChill Partners to set an annual refrigerant emission
reduction goal and develop a refrigerant management plan reflecting the
company's implementation objectives. Implementation of the Partners'
refrigeration management plan to reduce refrigerant emissions enhances
the protection of the environment and may save Partners money and
improve operational efficiency. The GreenChill Program offers the
opportunity for any individual store to earn GreenChill Certification
at the silver-, gold-, platinum-, or other level when it demonstrates
that the amount of refrigerant used is below a specified limit, based
on the store's million British Thermal Units per hour (MBTU/hr) cooling
load, and that the refrigerant emitted from the store in the prior 12
months is below a specified percentage depending on each GreenChill
Store Certification level. Information submitted for the certification
of individual stores is compared to these set criteria for each
certification level. The certification of a store provides the
opportunity for broad recognition within the food retail industry and
with the store's customers.

Form Numbers

 GreenChill Advanced Refrigeration Partnership Agreement for
Chemical Manufacturers--EPA Form No.: 5900-214; OMB Control No.: 2060-
0702
 GreenChill Advanced Refrigeration Partnership Agreement for
Supermarket Partners--EPA Form No.: 5900-214; OMB Control No.: 2060-
0702

 GreenChill Advanced Refrigeration Partnership Agreement for
Refrigeration Systems Manufacturers--EPA Form No.: 5900-214; OMB
Control No.: 2060-0702
 GreenChill Installed Refrigerant and Emissions Corporate
Report for Food Retail--EPA Form No.: 5900-213; OMB Control No.: 2060-
0702
 Refrigeration System Manufacturers Corporate Reporting Form--
EPA Form No.: 5900-591; OMB Control No.: 2060-0702
 Corporate Refrigerant Management Plan Template for GreenChill
Partners--EPA Form No.: 5900-592 OMB Control No.: 2060-0702
 GreenChill Advanced Refrigeration Partnership Installation
Leak Tightness Testing: Verification Form--EPA Form No.: 5900-589; OMB
Control No.: 2060-0702
 GreenChill Advanced Refrigeration Partnership Fully
Operational Food Retail Stores--EPA Form No.: 5900-587; OMB Control
No.: 2060-0702
 GreenChill Advanced Refrigeration Partnership Recertification
of Food Retail Stores--EPA Form No.: 5900-588; OMB Control No.: 2060-
0702
 GreenChill Advanced Refrigeration Partnership Newly
Constructed Food Retail Stores--EPA Form No.: 5900-586; OMB Control
No.: 2060-0702
 GreenChill Advanced Refrigeration Partnership Bulk Application
for GreenChill Store Certification--EPA Form No.: 5900-590; OMB Control
No.: 2060-0702

    Respondents/affected entities: The following list of North American
Industry Classification System (NAICS) codes for organizations
potentially affected by the information requirements covered under this
ICR are:

 445110 Supermarkets

    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 805 (per year).
    Frequency of response: Annual, and when desired.
    Total estimated burden: 5,863 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $489,711 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in estimates: There is an increase of 3,255 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This increase is primarily due to growth, by a factor
of almost four, in the number of stores participating in the Store
Certification Program.

Cynthia A. Newberg,
Director, Stratospheric Protection Division.
[FR Doc. 2022-18208 Filed 8-23-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Rules and Regulations]
[Page 50914-50922]
[DOCID:fr18au10-25]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0099; FRL-8836-2]

Flubendiamide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes, reassesses, modifies and revokes
tolerances for residues of flubendiamide, N\2\-[1,1-dimethyl-2-
(methylsulfonyl)ethyl-3-iodo-N\1\-[2-methyl-4-[1,2,2,2-tetrafluoro-1-
(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide, in/on multiple
food and livestock commodities which are identified, and will be
discussed in detail later in this document. Bayer CropScience, LP in c/
o Nichino America, Inc. (U.S. subsidiary of Nihon Nohyaku Co., Ltd.)
requested these tolerances under the Federal Food, Drug and Cosmetic
Act (FFDCA).

DATES: This regulation is effective August 18, 2010. Objections and
requests for hearings must be received on or before October 18, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0099. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Carmen Rodia, Registration Division
(7504P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How Can I File an Objection or Hearing Request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2007-0099 in the subject line on the first
page of your submission. All objections and requests for a hearing

must be in writing, and must be received by the Hearing Clerk on or
before October 18, 2010. Addresses for mail and hand delivery of
objections and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2007-0099, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of March 19, 2010 (75 FR 13277-13280) (FRL-
8813-2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
9F7553, 9E7554 and 9F7555) by Bayer CropScience, LP in c/o Nichino
America, Inc. (U.S. subsidiary of Nihon Nohyaku Co., Ltd.), P.O. Box
12014, Research Triangle Park, NC 27709-2014. The petition requested
that 40 CFR 180.639 be amended by establishing tolerances for residues
of flubendiamide, N\2\-[1,1-Dimethyl-2-(methylsulfonyl)ethyl-3-iodo-
N\1\-[2-methyl-4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-
1,2-benzenedicarboxamide, in/on pea and bean, succulent shelled,
subgroup 6B at 0.04 parts per million (ppm); pea and bean, dried
shelled, except soybean, subgroup 6C at 0.80 ppm; rice, grain at 0.50
ppm (PP 9E7554); soybean, aspirated grain fractions at 91 ppm; soybean,
forage at 18 ppm; soybean, hay at 60 ppm; soybean, hulls at 0.70 ppm;
soybean, seed at 0.25 ppm; vegetable, foliage of legume, except
soybean, subgroup 7A at 35 ppm; vegetable, legume, edible podded,
subgroup 6A at 0.50 ppm; and rice, straw as a rotational crop at 0.07
ppm (PP 9F7555). That notice referenced a summary of the petitions
prepared by Bayer CropScience, LP in c/o Nichino America, Inc. (U.S.
subsidiary of Nihon Nohyaku Co., Ltd.), the registrant, which is
available in the docket, http://www.regulations.gov. There were no
substantive comments received in response to the notice of filing.
Based upon review of the data supporting these petitions, EPA has
reassessed, modified and revoked some of the existing tolerances for
flubendiamide. In addition, EPA has also determined that in primary and
rotational crops, the residue of concern for both the tolerance
expression and risk assessment is flubendiamide. In livestock, the
residue of concern for tolerance expression is flubendiamide. The
reason for these changes is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of flubendiamide in/on pea and bean, dried
shelled, except soybean, subgroup 6C; pea and bean, succulent shelled,
subgroup 6B; rice, grain; soybean, aspirated grain fractions; soybean,
forage; soybean, hay; soybean, hulls; soybean, seed; vegetable, foliage
of legume, except soybean, subgroup 7A; vegetable, legume, edible
podded, subgroup 6A; and rice, straw as a rotational crop. EPA's
assessment of exposures and risks associated with flubendiamide
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Flubendiamide has a low acute toxicity via the oral, dermal and
inhalation routes of exposure. Though it is a slight irritant to the
eye, flubendiamide is not a skin irritant and it is not a skin
sensitizer under the conditions of the guinea pig maximization test.
    In the mammalian toxicology database, the primary target organ of
flubendiamide exposure is the liver, with secondary effects reported in
the thyroid and kidney at equivalent or higher doses; no-observed-
adverse-effect-levels (NOAELs) established to protect for liver
toxicity are protective of effects seen in the thyroid and kidney.
Adverse adrenal effects were also noted in the dog.
    Buphthalmia, eye enlargement, opacity, and exophthalmus with
hemorrhage appearing only in infancy, were observed in rat offspring in
the reproductive and DNT studies. There was no clear dose-response
relationship for this effect but ocular toxicity was noted in three rat
studies and accompanied by histopathological findings of synechia,
hemorrhage, keratitis, iritis, and cataracts. Therefore, bupthalmos is
considered an effect of treatment. No evidence of cancer was seen for
flubendiamide in cancer bioassays in mice and rats. Flubendiamide was
also negative in mutagenicity testing. Accordingly, flubendiamide was
classified as ``Not Likely to be Carcinogenic to Humans.''
    More detailed information on the studies received and the nature of
the adverse effects caused by flubendiamide as well as the NOAEL and
the lowest-observed-adverse-effect-level (LOAEL) from the toxicity
studies can be found in the document entitled, ``Flubendiamide: Human
Health Risk Assessment for Proposed Uses on Corn, Cotton, Tobacco, Tree
fruit, Tree nuts, Vine crops and Vegetable Crops,'' dated

April 3, 2008, by going to http://www.regulations.gov. The referenced
document is available in the docket established by this action, which
is described under ADDRESSES. Locate and click on the hyperlink for
docket ID number EPA-HQ-OPP-2007-0099. Double-click on the document to
view the referenced information on pages 65 to 70 of 105.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level -- generally referred to as
a population-adjusted dose (PAD) or a reference dose (RfD) -- and a
safe margin of exposure (MOE). For non-threshold risks, the Agency
assumes that any amount of exposure will lead to some degree of risk.
Thus, the Agency estimates risk in terms of the probability of an
occurrence of the adverse effect expected in a lifetime. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://
www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for flubendiamide used for
human risk assessment can be found in the document entitled,
``Flubendiamide: Human Health Risk Assessment for Proposed Uses on
Corn, Cotton, Tobacco, Tree fruit, Tree nuts, Vine crops and Vegetable
crops,'' dated April 3, 2008, by going to http://www.regulations.gov.
The referenced document is available in the docket established by this
action, which is described under ADDRESSES. Locate and click on the
hyperlink for docket ID number EPA-HQ-OPP-2007-0099. Double-click on
the document to view the referenced information on pages 37 to 38 of
105.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flubendiamide, EPA considered exposure under the
petitioned-for tolerances as well as all existing flubendiamide
tolerances in 40 CFR 180.639. Acute and chronic dietary (food and
drinking water) exposure assessments were conducted using the Dietary
Exposure Evaluation Model, Version 2.03 (DEEM-FCID\TM\) which uses food
consumption information from the United States Department of
Agriculture's (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys
of Food Intake by Individuals (CSFII). EPA assessed dietary exposures
from flubendiamide in food for the proposed new uses on legume
vegetables, soybeans and a tolerance on imported rice as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for flubendiamide. In estimating acute dietary exposure, EPA used DEEM-
FCID\TM\ along with food consumption information from the USDA 1994-
1996 and 1998 CSFII. As to residue levels in food, for the acute
assessment, the modeled exposure estimates are based on tolerance level
residues, assuming 100% of crops were treated. In addition, default
processing factors were assumed for both registered and requested crop
uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used DEEM-FCID\TM\ along with the food consumption data
from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food,
EPA assumed all currently registered crops contain residues at the
average residue levels found in the crop field trials. For the newly
proposed crops and for livestock commodities, EPA assumed tolerance
level residues. In addition, experimental processing factors were used
where available. Finally, EPA assumed 100% of crops were treated.
    iii. Cancer. As explained above, flubendiamide is considered to be
``Not Likely to be Carcinogenic to Humans.'' As a result, cancer
exposure assessment is not needed for flubendiamide.
    iv. Anticipated residue information. Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and information on the anticipated
residue levels of pesticide residues in food and the actual levels of
pesticide residues that have been measured in food. If EPA relies on
such information, EPA must require, pursuant to section 408(f)(1) of
FFDCA that data be provided 5 years after the tolerance is established,
modified or left in effect, demonstrating that the levels in food are
not above the levels anticipated. For the present action, EPA will
issue such data call-ins as are required by section 408(b)(2)(E) of
FFDCA and authorized under section 408(f)(1) of FFDCA. Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    More detailed information on the acute and chronic aggregate
dietary assessment for flubendiamide used for human risk assessment can
be found in the document entitled, ``Flubendiamide: Acute and Chronic
Aggregate Dietary (Food and Drinking Water) Exposure and Risk
Assessments for the Proposed Section 3 Registration Action on Legume
Vegetables and Soybeans and a Tolerance on Imported Rice,'' dated March
31, 2010, by going to http://www.regulations.gov. The referenced
document is available in the docket established by this action, which
is described under ADDRESSES. Locate and click on the hyperlink for
docket ID number EPA-HQ-OPP-2007-0099. Double-click on the document to
view the referenced information on pages 10 to 11 of 26.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flubendiamide in drinking water. These simulation models
take into account data on the physical, chemical and fate/transport
characteristics of flubendiamide. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Flubendiamide is persistent and potentially mobile in terrestrial
and aquatic environments. These fate properties suggest that it has a
potential to move into surface and ground water. The Agency has
completed a drinking water assessment for flubendiamide using screening
level water exposure models that were based on the proposed new uses on
legume vegetables, rice grain and Christmas trees. Based on the
modeling analysis performed for the proposed new uses, the estimated
drinking water concentrations (EDWCs) are less than the reported values
previously assessed for the existing uses. For the 1 in 10 year peak,
the highest Tier 2 Pesticide Root Zone Model /Exposure Analysis
Modeling System (PRZM/EXAMS) EDWC for flubendiamide was 12.93 [mu]g/L
(approx.

13 [mu]g/L), based on application to Illinois corn. For the 1 in 10
year annual average, the highest PRZM/EXAMS EDWC was 11.95 [mu]g/L
(approx. 12 [mu]g/L), also based on application to Illinois corn.
    A summary of the dietary exposure from drinking water for
flubendiamide used for human risk assessment can be found in the
documents entitled, ``Flubendiamide: Human Health Risk Assessment for
Proposed Uses on Legume Vegetables, Soybeans and Christmas Trees, and
to Establish a Tolerance on Imported Rice Grain,'' dated April 30,
2010, ``Amendment: Flubendiamide: Human Health Risk Assessment for
Proposed Uses on Legume Vegetables, Soybeans and Christmas Trees, and
to Establish a Tolerance on Imported Rice Grain,'' dated June 28, 2010,
and ``Flubendiamide: Bridging Residue Study Conducted with an Adjuvant
in Support of Proposed Uses on Soybeans and Legumes,'' dated July 13,
2010, by going to http://www.regulations.gov. The referenced document
is available in the docket established by this action, which is
described under ADDRESSES. Locate and click on the hyperlink for docket
ID number EPA-HQ-OPP-2007-0099. Double-click on the document to view
the referenced information on pages 25 to 26 of 56.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Flubendiamide is not registered for any specific use patterns that
would result in residential exposure. That is, no residential uses are
being requested for flubendiamide at this time; therefore, no
residential risk assessment has been conducted.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found flubendiamide to share a common mechanism of
toxicity with any other substances, and flubendiamide does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action; therefore, EPA has assumed that
flubendiamide does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10x) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10x, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Pre-natal and post-natal sensitivity. While both the rat and
rabbit developmental studies did not identify teratogenic effects and
showed no evidence of increased pre-natal susceptibility, adverse eye
effects (eye enlargement) were noted in post-natal rat pups older than
14 days in multiple studies (the 2-generation reproduction and 1-
generation supplemental studies). Additionally, the developmental
neurotoxicity (DNT) study reported eye effects appearing in some
offspring between lactation days 14 and 42, even though exposure
stopped at lactation day 21, indicating a possible delay (a latent
response) from the time of last exposure to onset of bupthalmos. These
eye effects did not occur in adult rats. Since the iris and chamber
angle are differentiating and specializing into definite structures
during post-natal days 5 to 20, neonatal rats appear to have an
increased susceptibility to flubendiamide exposure as compared to
adults. The DNT study also reported that pre-mating exposures are not
required to elicit the eye effect in pups.
    In addition to the reported eye effects in the DNT study, there was
also a balanopreputial seperation (separation of the prepuce (foreskin)
from the glans penis (balanus)) delay. While this effect is generally
considered adverse per se, it is not assumed to be a developmental
effect from in utero exposure. Here, delayed balanopreputial separation
is considered secondary to reduced post-natal pup body weight as a
result of post-natal exposure. Futhermore, it was resolved within the
appropriate age range of puberty and no effects on reproductive
function were observed in the multigeneration study in rats. Delayed
balanopreputial separation was seen only at doses causing maternal
toxicity and is not more severe than the maternal effects of
hepatotoxicity seen at the common pup/maternal LOAEL of the DNT study.
Accordingly, the delayed balanopreputial separation seen in the DNT
study does not cause concern for increased sensitivity to the young for
flubendiamide.
    Human microsomes have been shown to be capable of approximately 4
times higher hydroxylation rates of flubendiamide as compared to female
mouse microsomes and may be able to efficiently metabolize and excrete
flubendiamide, preventing accumulation of the parent compound. It
remains unclear whether the ability to metabolize and clear the parent
compound is the only requirement to avoid ocular toxicity. Due to the
potential concern for increased susceptibility of the human neonate
compared to adults, this perinatal ocular effect is considered in the
human health risk assessment for flubendiamide.
    3. Conclusion. EPA evaluated the quality of the toxicity and
exposure data and, based on these data, has determined that the safety
of infants and children would be adequately protected if the FQPA SF
were reduced to 1x. That decision is based on the following findings:
    i. The toxicology database for flubendiamide is complete with the
exception of a subchronic neurotoxicity study which is now a new data
requirement under 40 CFR part 158; however, the existing data are
sufficient for endpoint selection for exposure/risk assessment
scenarios, and for evaluation of the requirements under the FQPA.
Flubendiamide is not a neurotoxic chemical based on neurotoxicity
assessments conducted acutely, developmentally and incorporated within
the chronic rat study. In several short-term studies in rats (subacute
and subchronic feeding, plaque-forming cell assay, one-generation
pilot, developmental toxicity) no neurobehavioral signs were observed
at doses up to and exceeding the limit dose; therefore, an additional
database uncertainty factor is not needed to account for potential
neurotoxicity.
    ii. Although susceptibility was identified in the toxicological
database (eye effects), the selected regulatory PODs (which are based
on clear NOAELs) are protective of these effects; therefore, the human
health risk assessment is protective.

    iii. There are no treatment-related neurotoxic findings in the
acute neurotoxicity and DNT studies in rats; although eye effects were
observed in the DNT study. As noted above, the PODs employed in the
risk assessment are protective of this effect.
    iv. There are no residual uncertainties identified in the exposure
databases and the exposure assessment is protective. The acute dietary
food exposure assessment utilizes tolerance-level residues, the chronic
dietary food exposure assessment utilizes average residue levels found
in the crop field trials/livestock commodities and both assume 100% of
crops with requested uses of flubendiamide are treated. The drinking
water assessment generated EDWCs using models and associated modeling
parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations. The highest
relevant EDWCs were used in the dietary (food and drinking water)
exposure assessment. By using these screening-level exposure
assessments in the acute and chronic dietary (food and drinking water)
assessments, risk is not underestimated for flubendiamide.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-, intermediate- and chronic-term risks are evaluated by comparing
the estimated aggregate food, water, and residential exposure to the
appropriate PODs to ensure that an adequate MOE exists.
    For this action, there is potential exposure to flubendiamide from
food and drinking water, but not from residential use sites (as there
are no proposed or existing residential uses for flubendiamide). Since
hazard was identified via the oral route over both the acute and
chronic duration, the aggregate risk assessment considers exposures
from food and drinking water consumed over the acute and chronic
durations.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to flubendiamide will occupy less than 7% of the aPAD for the mostly
highly exposed population subgroup, children aged 1-2 years old.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flubendiamide from food and water will utilize 40% of the cPAD for the
mostly highly exposed population subgroup, children aged 1-2 years old.
There are no proposed or existing residential uses for flubendiamide.
    3. Aggregate cancer risk for U.S. population. Based on the evidence
discussed above, flubendiamide has been classified as ``Not Likely to
be Carcinogenic to Humans'' and is not expected to pose a cancer risk.
    4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to flubendiamide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (LC/MS/MS, Methods 00816/M002 and
00912) is available to enforce the tolerance expression. The method may
be requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Road, Fort Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by section
408(b)(4) of FFDCA. The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, section 408(b)(4) of FFDCA requires that EPA
explain the reasons for departing from the Codex level.
    There are currently no established Codex, Canadian or Mexican MRLs
for residues of flubendiamide in/on various food or livestock
commodities.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting PP 9F7553, 9E7554 and
9F7555, EPA has determined that in primary and rotational crops, the
residue of concern for both the tolerance expression and risk
assessment is flubendiamide. In livestock, the residue of concern for
tolerance expression is flubendiamide; the residues of concern in
livestock for risk assessment are flubendiamide and metabolite A14. EPA
is creating a separate subsection in the flubendiamide tolerance
section (paragraph (a)(2)) for the new tolerances and animal tolerances
affected by the new tolerances that reflects this determination on the
appropriate tolerance expression. The new subsection makes clear that,
as provided by section 408 of FFDCA, the tolerance covers flubendiamide
metabolites and degradates.
    The Agency's Guidance for Setting Pesticide Tolerances Based on
Field Trial Data was utilized for determining appropriate tolerance
levels for many RACs which showed quantifiable residues in or on
samples that were treated according to the proposed use patterns. Many
of the assessed RAC tolerances are consistent with the levels proposed
by the petitioner.
    EPA generally establishes a generic tolerance for ``aspirated grain
fractions'' based on uses of a pesticide on corn, wheat, sorghum and
soybean. If the pesticide is used on several crops, the RAC with the
highest residues in aspirated grain fractions will be used to establish
the tolerance. Residue data for the aspirated grain fractions of field
corn were reviewed in PP 6F7065, which led to the establishment of the
current 5.0 ppm tolerance for aspirated grain fractions. Based on the
registered use on field corn, and the proposed use on soybeans, EPA has
determined that the established tolerance for aspirated grain fractions
be revised from 5.0 ppm to 103 ppm.
    As part of this regulation, permanent tolerances for residues of
flubendiamide in or on soybean forage (18 ppm) and soybean hay (60 ppm)
resulting from direct application to the primary crop are established.
These tolerances supersede the currently listed tolerances for indirect
or inadvertent residues of flubendiamide in/on soybean forage (0.02
ppm) and soybean hay (0.04 ppm), and therefore the indirect/inadvertent
residue tolerances are being revoked from 40 CFR 180.639(d).
    The established tolerances for meat, milk, poultry and eggs were
also reassessed in light of the recalculated beef and dairy cattle,
swine and poultry dietary burdens and following consideration of the
newly-proposed uses and reevaluation of previously submitted animal
feeding studies. The Agency concludes that the established

tolerances for residues of flubendiamide for milk, milk fat, meat
byproducts (previously listed as liver and kidney separately), meat and
fat of cattle, goat, horse and sheep should be increased to 0.15 ppm,
0.80 ppm, 0.60 ppm, 0.07 ppm and 0.60 ppm, respectively. For swine, EPA
concludes that tolerances need to be added on meat byproducts at 0.01
ppm and on fat at 0.01 ppm. For poultry, EPA concludes that the
established tolerance for meat (0.01 ppm) remains adequate; however,
tolerances for egg, fat and liver need to be raised to 0.03 ppm, 0.15
ppm and 0.03 ppm, respectively.
    The submitted Section F of the rice petition does not include any
tolerance proposal on rice straw (PP 9F7555). Rice straw is not a
significant livestock feedstuff as per Table 1 of Guideline 860.1000;
therefore, a rotational crop tolerance on rice straw is not needed and
will not be approved as part of this regulation.

V. Conclusion

    Therefore, new tolerances are being established for residues of
flubendiamide, N\2\-[1,1-Dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N\1\-
[2-methyl-4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-
benzenedicarboxamide, in/on grain, aspirated grain fractions at 103
ppm; pea and bean, dried shelled, except soybean, subgroup 6C at 0.60
ppm; pea and bean, succulent shelled, subgroup 6B at 0.05 ppm; rice,
grain at 0.50 ppm; soybean, forage at 18 ppm; soybean, hay at 60 ppm;
soybean, hulls at 0.80 ppm; soybean, seed at 0.25 ppm; vegetable,
foliage of legume, except soybean, subgroup 7A at 35 ppm; and
vegetable, legume, edible podded, subgroup 6A at 0.50 ppm.
    The established tolerances for residues of flubendiamide for milk,
milk fat, meat byproducts (previously listed as liver and kidney
separately), meat and fat of cattle, goat, horse and sheep are being
increased to 0.15 ppm, 0.80 ppm, 0.60 ppm, 0.07 ppm and 0.60 ppm,
respectively. Additionally, the extablished tolerances for egg, fat and
liver are being increased to 0.03 ppm, 0.15 ppm and 0.03 ppm,
respectively.
    The established tolerances on liver (0.30 ppm) and kidney (0.30
ppm) for cattle, goat, horse and sheep, listed in 40 CFR 180.639(a),
are being superseded by renamed tolerances for meat byproducts for
cattle, goat, horse and sheep (0.60 ppm) in the newly created
subsection, 40 CFR 180.639(a)(2). The established tolerances for
indirect or inadvertent residues of flubendiamide in/on soybean, forage
(0.02 ppm) and soybean, hay (0.04 ppm) are being revoked from 40 CFR
180.639(d), and are being superseded by the new soybean and legume
vegetable tolerances listed in 40 CFR 180.639(a)(2).

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 10, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.639 is revised to read as follows:

Sec. 180.639  Flubendiamide; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
insecticide flubendiamide per se, N\2\-[1,1-Dimethyl-2-
(methylsulfonyl)ethyl-3-iodo-N\1\-[2-methyl-4-[1,2,2,2-tetrafluoro-1-
(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide, in or on the
following commodities:

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Almond, hulls                                                                                9.0 ppm
----------------------------------------------------------------------------------------------------------------
Apple, wet pomace                                                                                2.0 ppm
----------------------------------------------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A                                                                    0.60 ppm
----------------------------------------------------------------------------------------------------------------
Brassica, leafy greens, subgroup 5B                                                                      5.0 ppm
----------------------------------------------------------------------------------------------------------------
Corn, field, forage                                                                                8.0 ppm
----------------------------------------------------------------------------------------------------------------
Corn, field, grain                                                                                0.02 ppm
----------------------------------------------------------------------------------------------------------------
Corn, field, stover                                                                                0.15 ppm
----------------------------------------------------------------------------------------------------------------
Corn, sweet, forage                                                                                9.0 ppm
----------------------------------------------------------------------------------------------------------------
Corn, sweet, kernel plus cob with husks removed                                                         0.01 ppm
----------------------------------------------------------------------------------------------------------------
Corn, sweet, stover                                                                                0.25 ppm
----------------------------------------------------------------------------------------------------------------
Cotton gin byproducts                                                                                0.60 ppm
----------------------------------------------------------------------------------------------------------------
Cotton, undelinted seed                                                                                0.90 ppm
----------------------------------------------------------------------------------------------------------------
Fruit, pome, group 11                                                                                0.70 ppm
----------------------------------------------------------------------------------------------------------------
Fruit, stone, group 12                                                                                1.6 ppm
----------------------------------------------------------------------------------------------------------------
Grape                                                                                1.4 ppm
----------------------------------------------------------------------------------------------------------------
Nut, tree, group 14                                                                                0.06 ppm
----------------------------------------------------------------------------------------------------------------
Okra                                                                                0.30 ppm
----------------------------------------------------------------------------------------------------------------
Vegetable, cucurbit, group 9                                                                            0.20 ppm
----------------------------------------------------------------------------------------------------------------
Vegetable, fruiting, group 8                                                                            0.60 ppm
----------------------------------------------------------------------------------------------------------------
Vegetable, leafy, except Brassica, group 4                                                                11 ppm
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------

    (2) Tolerances are established for residues of flubendiamide,
including its metabolites and degradates, in or on the commodities
listed in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only flubendiamide,
N\2\-[1,1-dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N\1\-[2-methyl-4-
[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-
benzenedicarboxamide, in or on the following commodities:

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Cattle, fat                                                                                0.60 ppm
----------------------------------------------------------------------------------------------------------------
Cattle, meat byproducts                                                                                0.60 ppm
----------------------------------------------------------------------------------------------------------------
Cattle, meat                                                                                0.07 ppm
----------------------------------------------------------------------------------------------------------------
Eggs                                                                                0.03 ppm
----------------------------------------------------------------------------------------------------------------
Goat, fat                                                                                0.60 ppm
----------------------------------------------------------------------------------------------------------------
Goat, meat byproducts                                                                                0.60 ppm
----------------------------------------------------------------------------------------------------------------
Goat, meat                                                                                0.07 ppm
----------------------------------------------------------------------------------------------------------------
Grain, aspirated grain fractions                                                                         103 ppm
----------------------------------------------------------------------------------------------------------------
Horse, fat                                                                                0.60 ppm
----------------------------------------------------------------------------------------------------------------
Horse, meat byproducts                                                                                0.60 ppm
----------------------------------------------------------------------------------------------------------------
Horse, meat                                                                                0.07 ppm
----------------------------------------------------------------------------------------------------------------
Milk                                                                                0.15 ppm
----------------------------------------------------------------------------------------------------------------

Milk, fat                                                                                0.80 ppm
----------------------------------------------------------------------------------------------------------------
Pea and bean, dried shelled, except soybean, subgroup                                                   0.60 ppm
 6C
----------------------------------------------------------------------------------------------------------------
Pea and bean, succulent shelled, subgroup 6B                                                            0.05 ppm
----------------------------------------------------------------------------------------------------------------
Poultry, fat                                                                                0.15 ppm
----------------------------------------------------------------------------------------------------------------
Poultry, liver                                                                                0.03 ppm
----------------------------------------------------------------------------------------------------------------
Poultry, meat                                                                                0.01 ppm
----------------------------------------------------------------------------------------------------------------
Rice, grain\1\                                                                                0.50 ppm
----------------------------------------------------------------------------------------------------------------
Sheep, fat                                                                                0.60 ppm
----------------------------------------------------------------------------------------------------------------
Sheep, meat byproducts                                                                                0.60 ppm
----------------------------------------------------------------------------------------------------------------
Sheep, meat                                                                                0.07 ppm
----------------------------------------------------------------------------------------------------------------
Soybean, forage                                                                                18 ppm
----------------------------------------------------------------------------------------------------------------
Soybean, hay                                                                                60 ppm
----------------------------------------------------------------------------------------------------------------
Soybean, hulls                                                                                0.80 ppm
----------------------------------------------------------------------------------------------------------------
Soybean, seed                                                                                0.25 ppm
----------------------------------------------------------------------------------------------------------------
Vegetable, foliage of legume, except soybean, subgroup                                                    35 ppm
 7A
----------------------------------------------------------------------------------------------------------------
Vegetable, legume, edible podded, subgroup 6A                                                           0.50 ppm
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------

    \1\There are no U.S. registrations for rice, grain.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established
for residues of the insecticide flubendiamide per se, N\2\-[1,1-
Dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N\1\-[2-methyl-4-[1,2,2,2-
tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide,
in or on the following raw agricultural commodities when present
therein as a result of the application of flubendiamide to the growing
crops listed in paragraphs (a)(1) and (a)(2) of this section:

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Alfalfa, forage                                                                                0.15 ppm
----------------------------------------------------------------------------------------------------------------
Alfalfa, hay                                                                                0.04 ppm
----------------------------------------------------------------------------------------------------------------
Barley, hay                                                                                0.04 ppm
----------------------------------------------------------------------------------------------------------------
Barley, straw                                                                                0.07 ppm
----------------------------------------------------------------------------------------------------------------
Buckwheat                                                                                0.07 ppm
----------------------------------------------------------------------------------------------------------------
Clover, forage                                                                                0.15 ppm
----------------------------------------------------------------------------------------------------------------
Clover, hay                                                                                0.04 ppm
----------------------------------------------------------------------------------------------------------------
Grass, forage                                                                                0.15 ppm
----------------------------------------------------------------------------------------------------------------
Grass, hay                                                                                0.04 ppm
----------------------------------------------------------------------------------------------------------------
Millet, pearl, forage                                                                                0.15 ppm
----------------------------------------------------------------------------------------------------------------
Millet, pearl, hay                                                                                0.04 ppm
----------------------------------------------------------------------------------------------------------------
Millet, proso, forage                                                                                0.15 ppm
----------------------------------------------------------------------------------------------------------------
Millet, proso, hay                                                                                0.04 ppm
----------------------------------------------------------------------------------------------------------------
Millet, proso, straw                                                                                0.07 ppm
----------------------------------------------------------------------------------------------------------------

Oats, forage                                                                                0.15 ppm
----------------------------------------------------------------------------------------------------------------
Oats, hay                                                                                0.04 ppm
----------------------------------------------------------------------------------------------------------------
Oats, straw                                                                                0.07 ppm
----------------------------------------------------------------------------------------------------------------
Rye, forage                                                                                0.15 ppm
----------------------------------------------------------------------------------------------------------------
Rye, straw                                                                                0.07 ppm
----------------------------------------------------------------------------------------------------------------
Sorghum, grain, forage                                                                                0.03 ppm
----------------------------------------------------------------------------------------------------------------
Sorghum, grain, stover                                                                                0.06 ppm
----------------------------------------------------------------------------------------------------------------
Teosinte, forage                                                                                0.15 ppm
----------------------------------------------------------------------------------------------------------------
Teosinte, hay                                                                                0.04 ppm
----------------------------------------------------------------------------------------------------------------
Teosinte, straw                                                                                0.07 ppm
----------------------------------------------------------------------------------------------------------------
Triticale, forage                                                                                0.15 ppm
----------------------------------------------------------------------------------------------------------------
Triticale, hay                                                                                0.04 ppm
----------------------------------------------------------------------------------------------------------------
Triticale, straw                                                                                0.07 ppm
----------------------------------------------------------------------------------------------------------------
Wheat, forage                                                                                0.15 ppm
----------------------------------------------------------------------------------------------------------------
Wheat, hay                                                                                0.03 ppm
----------------------------------------------------------------------------------------------------------------
Wheat, straw                                                                                0.03 ppm
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2010-20443 Filed 8-17-10; 8:45 am]
BILLING CODE 6560-50-S