[Federal Register Volume 79, Number 242 (Wednesday, December 17, 2014)]
[Rules and Regulations]
[Pages 75044-75046]
[FR Doc No: 2014-29450]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 744 and 774

[Docket No. 140813667-4667-01]
RIN 0694-AG27

Expansion of the Microprocessor Military End-Use and End-User
Control

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: The Bureau of Industry and Security (BIS) is amending the
microprocessor military end-use and end-user control in the Export
Administration Regulations by expanding the scope of microprocessors
subject to the restriction to harmonize with technological advances to
microprocessor chips and expand the scope to include related software
and technology for the development and production of these chips. In
addition, this rule adds a prohibition on the use of license exceptions
(including License Exception ENC) and otherwise expands license
requirements for exports, reexports, or transfers (in-country) of
microprocessors subject to the military end-use and end-user
restriction. This expansion is consistent with the foreign policy
objectives of the United States of preventing U.S. exports that might
contribute to destabilizing military capabilities against the United
States and its citizens. The foreign policy report explaining the
expansion was sent to Congress on December 1, 2014. This rule also
expands the scope of controls to cover in-country transfers, in order
to control in-country transfers to prohibited military end users or end
uses. BIS is also making editorial and format revisions to this section
to improve clarity.

DATES: Effective date: This rule is effective December 17, 2014.

FOR FURTHER INFORMATION CONTACT: Sharron Cook, Office of Exporter
Services, Bureau of Industry and Security, Department of Commerce,
Phone:<PHONE_NUMBER> or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On January 14, 2003 (68 FR 1796), the Bureau of Industry and
Security (BIS) published a rule to implement the microprocessor
military end-user and end-use control in Sec.  744.17 of the Export
Administration Regulations (EAR). That rule imposed an end-use and end-
user based license requirement on the export of certain microprocessors
to military end uses and end users in countries in Country Group D:1
(see Supplement No. 1 to part 740 of the EAR).
    End-use and end-user based controls are in addition to any controls
based on the technical parameters of the item. Thus, the end-use and
end-user based license requirements set forth in Sec.  744.17 may apply
to a transaction, even if the Commerce Country Chart indicates there
are no license requirements, i.e., no ``X'' in the box. When controls
set forth under more than one section of the EAR apply to a
transaction, the license requirements for such a transaction will be
determined based on the requirements of all applicable sections of the
EAR, and license applications will be reviewed under all applicable
licensing policies.
    To determine license requirements, one should follow the decision
tree flowchart in Supplement No. 1 to part 732. An ECCN may have
multiple license requirements, e.g., CCL-based, end-use based, or end-
user based. Also note that to use a license exception, each license
requirement on an ECCN must be overcome.

Revisions to Sec.  744.17 ``Restrictions on Certain Exports, Reexports
and Transfers (in-country) of Microprocessors and Associated
``Software'' and ``Technology'' for `Military End Uses' and to
`Military End Users'''

    Since 744.17 was established, BIS's administration of export
controls has increasingly focused on end uses and end users. Consistent
with this change, BIS is adding in-country transfer controls to this
section of the EAR to incorporate restrictions that would apply even if
a transaction is licensed for a particular destination.
    BIS is also expanding the scope of microprocessors requiring a
license under Sec.  744.17 by removing the specific ECCN (3A991.a.1)
from the text, so that the prohibition applies to any microprocessor
meeting the specified performance criteria, and associated ``software''
and ``technology.'' As encryption and other ``information security''
functionality has become more commonplace in hardware, BIS has
concluded that microprocessors classified under any ECCN in Category
5--Part 2 of the EAR (including ECCN 5A992.c for `mass market'
encryption chips and ECCN 5A002 for a variety of non-`mass market'
microprocessors) warrant the same license requirement as BIS currently
requires under Sec.  744.17 for the microprocessors classified outside
of Category 5--Part 2, even if no license would be required (NLR) or
License Exception ENC would otherwise be available. Because of this
scope revision, the first sentence of paragraph (a) is revised to
clarify that this license requirement is in addition to all license
requirements set forth in the EAR and not just anti-terrorism reasons
for control. Furthermore, BIS is expanding the scope of the license
requirement in Sec.  744.17 to include ``technology'' and ``software''
for the ``development'' and ``production'' of the microprocessors
described in Sec.  744.17(a).
    In relation to Sec.  744.17(f) ``Exceptions,'' BIS is also moving,
from paragraph (a) to paragraph (f), text that exempted from Sec.
744.17 personnel and agencies of the U.S. Government or agencies of a
cooperating government under License Exception GOV. In

addition to harmonizing Sec.  744.17(f) with recent changes in License
Exception GOV, BIS is expanding paragraph (f) to include exports,
reexports and transfers (in-country) ``on behalf of'' the U.S.
Government or agencies of a cooperating government and updating and
incorporating the related citation references.
    BIS is also fixing the use of double and single quotes around the
terms in this section to increase clarity. Single quotes are used for
terms that are defined in a section where it appears, whereas double
quotes indicate a term defined in Sec.  772.1 of the EAR.

Revisions to the Supplement No. 1 to Part 774 ``Commerce Control List''

    This rule adds a reference to the license requirements in Sec.
744.17 in the affected ECCNs of the Commerce Control List.
Specifically, ECCNs 3A001, 3D002, 3D991, 3E001, 3E002, 3E991, 5A002,
5A992, 5D002, 5D992, 5E002 and 5E992 are amended by adding a License
Requirement Note after the Control Table in the License Requirements
section. This reference in the ECCN may help prevent exporters from
missing this combination item/end-use based license requirement.
    ECCN 3A991 already had a license requirement note pointing to the
license requirements in Sec.  744.17. This rule replaces the existing
note with the same one being added to the other twelve ECCNs in this
rule.

Export Administration Act

    Although the Export Administration Act expired on August 20, 2001,
the President, through Executive Order 13222 of August 17, 2001, 3 CFR,
2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March
8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of
August 7, 2014, 79 FR 46957 (August 11, 2014), has continued the Export
Administration Regulations in effect under the International Emergency
Economic Powers Act. BIS continues to carry out the provisions of the
Export Administration Act, as appropriate and to the extent permitted
by law, pursuant to Executive Order 13222 as amended by Executive Order
13637.

Savings Clause

    Shipments of items removed from license exception eligibility or
eligibility for export, reexport, or transfer (in-country) without a
license as a result of this regulatory action that were on dock for
loading, on lighter, laden aboard a carrier, or en route aboard a
carrier to a port, on December 17, 2014, pursuant to actual orders to a
destination, may proceed to that destination under the previous license
exception eligibility or without a license so long as they have been
exported, reexported, or transferred (in-country) before February 17,
2015. Any such items not actually exported, reexported, or transferred
(in-country) before midnight, on February 17, 2015, require a license
in accordance with this regulation.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been determined to be not significant for
purposes of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to nor be subject to a penalty for failure to
comply with a collection of information, subject to the requirements of
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA),
unless that collection of information displays a currently valid Office
of Management and Budget (OMB) Control Number. This regulation involves
collections previously approved by OMB under control number 0694-0088,
Simplified Network Application Processing System, which includes, among
other things, license applications and carries a burden estimate of
43.8 minutes for a manual or electronic submission. Total burden hours
associated with the PRA and OMB control number 0694-0088 are not
expected to increase as a result of this rule. You may send comments
regarding the collection of information associated with this rule,
including suggestions for reducing the burden, to Jasmeet K. Seehra,
Office of Management and Budget (OMB), by email to
<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>.
    3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
    4. The provisions of the Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed rulemaking, the opportunity for
public comment and a delay in effective date are inapplicable because
this regulation involves a military or foreign affairs function of the
United States. (See 5 U.S.C. 553(a)(1)). If this rule were delayed to
allow for notice and comment and a delay in effective date, these high
performance microprocessors, as well as associated development and
production technology and software would continue to be exported,
reexported and transferred (in-country) to military end uses or
military end users to the detriment of the national security or foreign
policy interests of the United States. In addition, publishing a
proposed rule would give notice of the U.S. Government's intention to
restrict the export, reexport and transfer of these items and would
create an incentive to either accelerate exports, reexports and
transfers of these items to conduct activities that are contrary to the
national security or foreign policy interests of the United States,
and/or to take steps to try to limit the impact of the this expanded
control once a final rule was published. No other law requires that a
notice of proposed rulemaking and an opportunity for public comment be
given for this rule. Because a notice of proposed rulemaking and an
opportunity for public comment are not required to be given for this
rule by 5 U.S.C. 553, or by any other law, the analytical requirements
of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are not
applicable. Accordingly, no regulatory flexibility analysis is required
and none has been prepared.

List of Subjects

15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

15 CFR Part 774

    Exports, Reporting and recordkeeping requirements.

    Accordingly, parts 744 and 774 of the Export Administration
Regulations (15 CFR parts 730-774) are amended as follows:

PART 744--[AMENDED]

0
1. The authority citation for 15 CFR part 744 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179;
E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR,
1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222,
66 FR

44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3 CFR,
2001 Comp., p. 786; Notice of January 21, 2014, 79 FR 3721 (January
22, 2014); Notice of August 7, 2014, 79 FR 46959 (August 11, 2014);
Notice of September 17, 2014, 79 FR 56475 (September 19, 2014);
Notice of November 7, 2014, 78 FR 67035 (November 12, 2014).

0
2. Revise Sec.  744.17 to read as follows:

Sec.  744.17  Restrictions on certain exports, reexports and transfers
(in-country) of microprocessors and associated ``software'' and
``technology'' for ``military end uses'' and to ``military end users.''

    (a) General prohibition. In addition to the license requirements
set forth elsewhere in the EAR, you may not export, reexport or
transfer (in-country) microprocessors (``microprocessor
microcircuits,'' ``microcomputer microcircuits,'' and microcontroller
microcircuits having a processing speed of 5 GFLOPS or more and an
arithmetic logic unit with an access width of 32 bit or more, including
those incorporating ``information security'' functionality), or
associated ``software'' and ``technology'' for the ``production'' or
``development'' of such microprocessors without a license if, at the
time of the export, reexport or transfer (in-country), you know, have
reason to know, or are informed by BIS that the item will be or is
intended to be used for a `military end use,' as defined in paragraph
(d) of this section, in a destination listed in Country Group D:1 (see
Supplement No. 1 to part 740 of the EAR); or by a `military end user,'
as defined in paragraph (e) of this section, in a destination listed in
Country Group D:1.
    (b) Additional prohibition on exporters or reexporters informed by
BIS. BIS may inform an exporter, reexporter or transferor, either
individually by specific notice or through amendment to the EAR, that a
license is required for export, reexport or transfer (in-country) of
items described in paragraph (a) of this section to specified end
users, because BIS has determined that there is an unacceptable risk of
diversion to the end uses or end users described in paragraph (a) of
this section. Specific notice is to be given only by, or at the
direction of, the Deputy Assistant Secretary for Export Administration.
When such notice is provided orally, it will be followed by a written
notice within two working days signed by the Deputy Assistant Secretary
for Export Administration. The absence of any such notification does
not excuse the exporter, reexporter or transferor from compliance with
the license requirements of paragraph (a) of this section.
    (c) License review standards. There is a presumption of denial for
applications to export, reexport or transfer (in-country) items subject
to this section.
    (d) Military end-use. In this section, the phrase `military end
use' means incorporation into: a military item described on the U.S.
Munitions List (USML) (22 CFR part 121, International Traffic in Arms
Regulations) or the Wassenaar Arrangement Munitions List (as set out on
the Wassenaar Arrangement Web site at http://www.wassenaar.org);
commodities classified under ECCNs ending in ``A018'' or under ``600
series'' ECCNs; or any commodity that is designed for the ``use,''
``development,'' ``production,'' or deployment of military items
described on the USML, the Wassenaar Arrangement Munitions List or
classified under ECCNs ending in ``A018'' or under ``600 series''
ECCNs. Supplement No. 1 of this part lists examples of `military end
use.'
    (e) Military end user. In this section, the term `military end
user' means the national armed services (army, navy, marine, air force,
or coast guard), as well as the national guard and national police,
government intelligence or reconnaissance organizations, or any person
or entity whose actions or functions are intended to support `military
end uses' as defined in paragraph (d) of this section.
    (f) Exceptions. The prohibitions described in paragraphs (a) and
(b) of this section supersede any license exception or No License
Required (NLR) designation that would otherwise apply to a transaction
subject to the EAR, except that this license requirement does not apply
to exports, reexports or transfers (in-country) of items for or on
behalf of the official use by personnel and agencies of the U.S.
Government or to agencies of a cooperating government authorized by
License Exception GOV pursuant to Sec.  740.11 of the EAR. See Sec.
740.11(b)(1) of the EAR for the definition of `agency of the U.S.
Government' and Sec.  740.11(c)(1) for the definition of `agency of a
cooperating government.'

PART 774--[AMENDED]

0
3. The authority citation for part 774 continues to read as follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et
seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42
U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 22
U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783; Notice of August 7, 2014, 79 FR 46959 (August 11, 2014).

Supplement No. 1 to Part 774--[Amended]

0
4. In Supplement No. 1 to part 774 (the Commerce Control List), ECCNs
3A001, 3D002, 3D991, 3E001, 3E002, 3E991, 5A002, 5A992, 5D002, 5D992,
5E002 and 5E992 are amended by adding a License Requirement Note after
the Control Table in the License Requirements section to read as
follows:

Supplement No. 1 to Part 774--Commerce Control List

* * * * *

License Requirements

* * * * *
    License Requirements Note: See Sec.  744.17 of the EAR for
additional license requirements for microprocessors having a processing
speed of 5 GFLOPS or more and an arithmetic logic unit with an access
width of 32 bit or more, including those incorporating ``information
security'' functionality, and associated ``software'' and
``technology'' for the ``production'' or ``development'' of such
microprocessors.
* * * * *

0
5. In Supplement No. 1 to part 774 (the Commerce Control List),
Category 3, ECCN 3A991 is amended by revising the License Requirements
Notes to read as follows:

3A991 Electronic Devices, and ``Components'' Not Controlled by 3A001.

License Requirements

* * * * *
    License Requirements Note: See Sec.  744.17 of the EAR for
additional license requirements for microprocessors having a processing
speed of 5 GFLOPS or more and an arithmetic logic unit with an access
width of 32 bit or more, including those incorporating ``information
security'' functionality, and associated ``software'' and
``technology'' for the ``production'' or ``development'' of such
microprocessors.
* * * * *

    Dated: December 11, 2014.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2014-29450 Filed 12-16-14; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Notices]
[Pages 71864-71865]
[FR Doc No: 2012-29280]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2012-46]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before December 24, 2012.

ADDRESSES: You may send comments identified by Docket Number FAA-2012-
0579 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://

www.regulations.gov, including any personal information you provide.
Using the search function of our docket Web site, anyone can find and
read the comments received into any of our dockets, including the name
of the individual sending the comment (or signing the comment for an
association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Keira Jones<PHONE_NUMBER>, or Tyneka
Thomas<PHONE_NUMBER>, Office of Rulemaking, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on November 29, 2012.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2012-0579
    Petitioner: Jetstream Aviation (Jetstream).
    Section of 14 CFR Affected: 14 CFR 125.1.
    Description of Relief Sought: Jetstream Aviation seeks relief from
applicability as stated in Sec.  125.1 to add its Challenger (CL-600-
2B16) aircraft to the Operations Specifications of Jetstream's existing
part 125 operating certificate.

[FR Doc. 2012-29280 Filed 12-3-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 52 (Friday, March 17, 2023)]
[Notices]
[Page 16465]
[FR Doc No: 2023-05437]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-570, OMB Control No. 3235-0632]

Submission for OMB Review; Comment Request; Extension: Rule 12h-
1(f)

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.
    Rule 12h-1(f) (17 CFR 240.12h-1(f)) under the Securities Exchange
Act of 1934 (``Exchange Act'') provides an exemption from the Exchange
Act Section 12(g) registration requirements for compensatory employee
stock options of issuers that are not required to file periodic reports
under the Exchange Act. The information required under Exchange Act
Rule 12h-1 is not filed with the Commission. Exchange Act Rule 12h-1(f)
permits issuers to provide the required information to the option
holders either by: (i) physical or electronic delivery of the
information; or (ii) written notice to the option holders of the
availability of the information on a password-protected internet site.
We estimate that it takes approximately 2 burden hours per response to
prepare and provide the information required under Rule 12h-1(f) and it
is prepared and provided by approximately 40 respondents. We estimate
that 25% of the 2 hours per response (0.5 hours per response) is
prepared by the company for a total annual reporting burden of 20 hours
(0.5 hours per response x 40 responses).
    An agency may conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
by April 17, 2023 to (i) www.reginfo.gov/public/do/PRAMain and (ii)
David Bottom, Director/Chief Information Officer, Securities and
Exchange Commission, c/o John Pezzullo, 100 F Street NE, Washington, DC
20549, or by sending an email to: [email protected].

    Dated: March 13, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-05437 Filed 3-16-23; 8:45 am]
BILLING CODE 8011-01-P


Notice of Receipt of a Clean Air Act Waiver Application to Increase the
Allowable Ethanol Content of Gasoline to 15 Percent – Meeting Notice

Date	EPA Attendees	Name of Organization 	Summary of Discussion

9/17/2010

	Margo Oge

<EMAIL_ADDRESS>
Karl Simon

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
Paul Argyropouls

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
Robert Anderson

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
Antonio Fernandez (by video)

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
Mary Manners (by video)

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>Representatives from the Archer Daniels Midlands Company (ADM) and the
Renewable Fuels Association (RFA) met with EPA to discuss Growth
Energy’s pending E15 waiver request.

Attendees in person: Shannon Herzfeld and Anthony Reed attended from
ADM, and Bob Dinneen and Chuck Knauss attended from RFA.	ADM and RFA
discussed their support for the E15 waiver to be granted for
introduction into commerce for all motor vehicles.  RFA discussed their
recently submitted report for vehicles MY1994-2000 (see Docket No. ID
EPA-HQ-OAR-2009-0211-14007) and ADM discussed their recently released
late comments requesting that EPA approve E12 use for all motor vehicles
(see Docket ID No. EPA-HQ-OAR-2009-0211-13995).


[Federal Register: May 27, 2009 (Volume 74, Number 100)]
[Rules and Regulations]
[Page 25156-25161]
[DOCID:fr27my09-5]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0554; FRL-8413-5]

Etoxazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
etoxazole in or on stone fruit; plum; prune; spearmint tops and oil;
peppermint tops and oil; tomato; and cucumber. This regulation also
deletes the existing cherry tolerance, as it will be superseded by
inclusion in the stone fruit crop group. The Interregional Research
Project Number 4 (IR-4) requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 27, 2009. Objections and
requests for hearings must be received on or before July 27, 2009, 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-2008-0554. 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: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2008-0554 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before July 27, 2009.
    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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0554, 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. Petition for Tolerance

    In the Federal Register of August 13, 2008 (73 FR 47186) (FRL-8375-
8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E7347) by IR-4, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201 W., Princeton, NJ 08540. The petition
requested that 40 CFR 180.593 be amended by establishing tolerances for
residues of the insecticide etoxazole, 2-(2,6-difluorophenyl)-4-[4-
(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-dihydrooxazole, in or on fruit,
stone, group 12, except plum at 1.0 parts per million (ppm); plum at
0.12 ppm; plum, prune, dried at 0.4 ppm; cucumber at 0.02 ppm; tomato
at 0.25; spearmint, tops at 10 ppm; peppermint, tops at 10 ppm;
peppermint, oil at 20 ppm; and spearmint, oil at 20 ppm. The petition
additionally requested to delete the tolerance for residues of
etoxazole in or on the food commodity cherry at 1.0 ppm. That notice
referenced a summary of the petition prepared on behalf of IR-4 by
Valent U.S.A. Corporation, the registrant, which is available to the
public in the docket, http://www.regulations.gov. Comments were
received on the notice of filing. EPA's response to these comments is
discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
revised the proposed tolerance levels for plum; plum, prune, dried; and
tomato. 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 etoxazole on fruit, stone, group 12, except
plum at 1.0 ppm; plum at 0.15 ppm; plum, prune, dried at 0.30 ppm;
cucumber at 0.02 ppm; tomato at 0.20; spearmint, tops at 10 ppm;
peppermint, tops at 10 ppm; peppermint, oil at 20 ppm; and spearmint,
oil at 20 ppm. EPA's assessment of exposures and risks associated with
establishing tolerances 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.
    The existing etoxazole data indicate that it possess low acute
toxicity via all routes of exposure. It is not an eye or dermal
irritant or a dermal sensitizer. No toxicity was seen at the limit dose
in a 28-day dermal toxicity study in rats.
    The liver is the main target organ in mice, rats and dogs. In a 90-
day toxicity study in dogs, increased liver weights and centrilobular
hepatocellular swelling in the liver were observed. Similar effects
were observed in a chronic toxicity study in dogs at similar doses,
indicating that systemic effects (mainly liver effects) occur at
similar dose levels following short- through long-term exposure without
increasing in severity. In a 90-day toxicity study in mice,
hepatotoxicity (increased relative liver weight, liver enlargement, and
centrilobular hepatocellular swelling) was observed at high doses.
Similar effects were observed at the high dose in a mouse
carcinogenicity study. Subchronic and chronic toxicity studies in rats
produced similar effects (increased liver weights, centrilobular
hepatocellular swelling, etc.) to those seen in mice and dogs. In
addition, slight increases in thyroid weights and incisors were
observed in subchronic and chronic toxicity studies in rats at high
doses and at terminal stages of the study. Toxicity was not observed at
the highest dose tested (HDT) in another carcinogenicity study in mice.
There is no evidence of immunotoxicity or neurotoxicity in any of the
submitted studies.
    Two studies in mice showed no evidence of carcinogenicity up to the
HDT. In a rat carcinogenicity study, which was deemed unacceptable due
to inadequate dosing, benign interstitial cell tumors (testis) and
pancreas benign islet cell adenomas were observed (in females) at the
high dose. These effects were not observed in an acceptable
carcinogenicity study in rats at higher doses. In special mechanistic
male rat studies there were no observable

changes in serum hormone levels (estradiol, luteinizing hormone (LH),
prolactin and testosterone) or reproductive effects (interstitial cell
proliferation or spermatogenesis) noted. EPA classified etoxazole as
``not likely to be carcinogenic to humans.'' Etoxazole is not
mutagenic.
    The toxicology data for etoxazole provides no indication of
increased susceptibility, as compared to adults, of rat and rabbit
fetuses to in utero exposure in developmental studies. The rabbit
developmental toxicity study included maternal toxic effects (liver
enlargement, decreased weight gain, and decreased food consumption) at
the same dose as developmental effects (increased incidences of 27
presacral vertebrae and 27 presacral vertebrae with 13th ribs). In the
two-generation reproduction study conducted with rats, offspring
toxicity was more severe (pup mortality) than parental toxicity
(increased liver and adrenal weights) at the same dose, indicating
increased qualitative susceptibility.
    Specific information on the studies received and the nature of the
adverse effects caused by etoxazole as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studiescan be found at http://
www.regulations.gov in document ``Etoxazole; Human Health Risk
Assessment for Proposed Uses on Stone Fruits, Cucumber, Tomato, and
Mint,'' pages 29-31 in docket ID number EPA-HQ-OPP-2008-0554.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
    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
greater than that 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 etoxazole used for
human risk assessment can be found at http://www.regulations.gov in
document ``Etoxazole; Human Health Risk Assessment for Proposed Uses on
Stone Fruits, Cucumber, Tomato, and Mint,'' page 15 in docket ID number
EPA-HQ-OPP-2008-0554.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to etoxazole, EPA considered exposure under the petitioned-for
tolerances as well as all existing etoxazole tolerances in (40 CFR
180.593). EPA assessed dietary exposures from etoxazole in food 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.
    No such effects were identified in the toxicological studies for
etoxazole; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used tolerance-level
residues and empirically determined (when available) or DEEM default
processing factors. Additionally, EPA assumed 100 percent crop treated
(PCT) for all commodities covered by proposed or existing tolerances.
    iii. Cancer. Two mouse studies showed no evidence of
carcinogenicity at the high dose. While benign interstitial cell tumors
in the testis and pancreas benign islet cell adenomas were observed in
an unacceptable rat carcinogenicity study, these effects were not seen
in a repeat study at higher doses. Furthermore, special mechanistic
male rat studies resulted in no observable changes in serum hormone
levels (estradiol, luteinizing hormone, prolactin and testosterone) or
reproductive effects (interstitial cell proliferation or
spermatogenesis). EPA determined that cancer risk concerns due to long-
term consumption of etoxazole residues are adequately addressed by the
chronic dietary exposure analysis; therefore, etoxazole was classified
as ``not likely to be carcinogenic to humans,'' and a quantitative
exposure assessment to evaluate cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
etoxazole. Tolerance level residues and 100 PCT were assumed for all
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for etoxazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of etoxazole. 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.
    Based on the First Index Reservoir Screening Tool (FIRST) model for
surface water, and Screening Concentration in Ground Water (SCI-GROW)
model for ground water, the estimated drinking water concentrations
(EDWCs) of etoxazole and its major metabolites (R-8 and R-13) for
surface water are estimated to be 15.73 parts per billion (ppb) for
acute exposures and 4.761 ppb for chronic exposures. For ground water,
the estimated drinking water concentration is estimated to be 0.746
ppb.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 4.761 ppb was used to
assess the contribution to drinking water.
    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). Etoxazole

is not registered for any specific use patterns that would result in
residential exposure.
    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 etoxazole to share a common mechanism of toxicity
with any other substances, and etoxazole does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that etoxazole 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. Prenatal and postnatal sensitivity. The toxicology data for
etoxazole provides no indication of increased susceptibility, as
compared to adults, of rat and rabbit fetuses to in utero exposure in
developmental studies. In a rat reproduction study, offspring toxicity
was more severe (pup mortality) than parental toxicity (increased liver
and adrenal weights) at the same dose; thereby indicating increased
qualitative susceptibility. Based on the above concerns, a Degree of
Concern Analysis was performed by EPA, which concluded that concern is
low since:
    i. The effects in pups are well-characterized with a clear NOAEL;
    ii. The pup effects occur at the same dose as parental toxicity;
and
    iii. The doses selected for various risk assessment scenarios are
lower than the doses that caused offspring toxicity.
    3. Conclusion. EPA has determined that reliable data show 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 toxicity database for etoxazole is complete except for acute
and subchronic neurotoxicity and immunotoxicity studies. Recent changes
to 40 CFR 180.158 make acute and subchronic neurotoxicity testing
(OPPTS Guideline 870.6200), and immunotoxicity testing (OPPTS Guideline
870.7800) required for pesticide registration. Because these testing
requirements went into effect shortly before the tolerance petition was
submitted, these studies are not yet available for etoxazole. However,
the available data for etoxazole do not show potential for
immunotoxicity. Further, there is no evidence of neurotoxicity in any
study in the toxicity database for etoxazole. Therefore, EPA does not
believe that conducting neurotoxicity and immunotoxicity studies will
result in a NOAEL lower than the NOAEL of 4.62 milligrams/kilograms/day
already established for etoxazole. Consequently, an additional database
uncertainty factor does not need to be applied.
    ii. There is no indication that etoxazole is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional Uncertainity Factors (UFs) to account for neurotoxicity.
    iii. Although there is qualitative evidence of increased
susceptibility of offspring (pup mortality) compared to less severe
parental effects (increased liver and adrenal weights) at the same dose
in the rat multi-generation reproduction study, the Agency did not
identify any residual uncertainties after establishing toxicity
endpoints and traditional UFs (10X for interspecies variation and 10X
for intraspecies variation) to be used in the risk assessment.
Therefore, there are no residual concerns regarding developmental
effects in the young.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to etoxazole in drinking water. These assessments
will not underestimate the exposure and risks posed by etoxazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
etoxazole is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
etoxazole from food and water will utilize 10% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
There are no residential uses for etoxazole to consider.
    3. Short-, and intermediate-term risk. Short-, and intermediate-
term aggregate exposure takes into account short-, and intermediate-
term residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Etoxazole is not registered for any use patterns that would result
in residential exposure. Therefore, the short-, and intermediate-term
aggregate risk is the sum of the risk from exposure to etoxazole
through food and water and will not be greater than the chronic
aggregate risk.
    4. Aggregate cancer risk for U.S. population. As discussed in Unit
III.C.1.iii., EPA has classified etoxazole as ``not likely to be
carcinogenic to humans,'' and it is not expected to pose a cancer risk
to humans.
    5. 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 etoxazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (gas chromatography/nitrogen-
phosphorus detection (GC/NPD) and gas chromatography/mass selective
detection (GC/MSD) methods) are available to enforce the tolerance
expression. The methods may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    Currently, there are no Codex, Canadian, or Mexican maximum residue
limits (MRLs) established for residues of etoxazole in or on the
subject commodities.

C. Response to Comments

    EPA received one comment to the Notice of Filing that made a
general objection to the presence of any pesticide residues on crops
and stated that EPA should set no pesticide tolerance greater than
zero. The Agency understands the commenter's concerns and recognizes
that some individuals believe that pesticides should be banned
completely. However, the existing legal framework provided by section
408 of FFDCA states that tolerances greater than zero may be set when
persons seeking such tolerances or exemptions have demonstrated that
the pesticide meets the safety standard imposed by that statute. This
citizen's comment appears to be directed at the underlying statute and
not EPA's implementation of it; the citizen has made no contention that
EPA has acted in violation of the statutory framework.

D. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA revised
tolerances for certain proposed commodities, as follows: Plum from 0.12
ppm to 0.15 ppm; plum, prune, dried from 0.40 ppm to 0.30 ppm; and
tomato from 0.25 ppm to 0.20 ppm. EPA revised the tolerance levels
based on analysis of the residue field trial data using the Agency's
Tolerance Spreadsheet in accordance with the Agency's Guidance for
Setting Pesticide Tolerances Based on Field Trial Data.

V. Conclusion

    Therefore, tolerances are established for residues of etoxazole, 2-
(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole, in or on fruit, stone, group 12, except plum at 1.0
ppm; plum at 0.15 ppm; plum, prune, dried at 0.30 ppm; cucumber at 0.02
ppm; tomato at 0.20 ppm; spearmint, tops at 10 ppm; peppermint, tops at
10 ppm; spearmint, oil at 20 ppm; and peppermint, oil at 20 ppm. This
regulation also deletes the existing tolerance in or on cherry at 1.0
ppm, as it is superseded by inclusion in fruit, stone, group 12.

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: May 15, 2009.
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 180.593 is amended in paragraph (a), by removing the
commodity ``Cherry'' and by alphabetically adding the following
commodities to the table to read as follows:

Sec.  180.593  Etoxazole; tolerances for residues.

     (a) General. * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Cucumber.............................................               0.02
                                * * * * *
Fruit, stone, group 12, except plum..................                1.0
                                * * * * *
Peppermint, oil......................................                 20
Peppermint, tops.....................................                 10
                                * * * * *
Plum.................................................               0.15
Plum, prune, dried...................................               0.30
                                * * * * *
Spearmint, oil.......................................                 20
Spearmint, tops......................................                 10
                                * * * * *
Tomato...............................................               0.20
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-12292 Filed 5-26-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: March 4, 2009 (Volume 74, Number 41)]
[Rules and Regulations]
[Page 9373-9377]
[DOCID:fr04mr09-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0065; FRL-8400-4]

Propoxycarbazone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of propoxycarbazone and its Pr-2-OH metabolite in or on grass, forage
and grass, hay. Bayer CropScience requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 4, 2009. Objections and
requests for hearings must be received on or May 4, 2009, 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-2008-0065. 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: Joanne I. Miller, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone 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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gpo/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2008-0065 in the subject line on
the first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk as required by 40 CFR
part 178 on or before May 4, 2009.
    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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0065, 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. Petition for Tolerance

    In the Federal Register of February 6, 2008 (73 FR 6964) (FRL-8350-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F7304) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014,
Research Triangle Park, NC 27709. The petition requested that 40 CFR
180.600 be amended by establishing tolerances for combined residues of
the herbicide propoxycarbazone, 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-
propoxy-1H-1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl] benzoate in or
on grass, forage and grass, hay at 20 parts per million (ppm) and 25
ppm and to amend the tolerances in 40 CFR 180.600 by increasing the
established tolerances for residues of the herbicide propoxycarbazone,
methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1-
yl)carbonyl]amino]sulfonyl]benzoate (Pr-2-OH MKH-6561) in or on the
food commodities cattle, goat, horse, sheep meat from 0.05 ppm to 0.1
ppm; meat byproducts from 0.3 ppm to 1.0 ppm; and milk from 0.03 ppm to
0.05 ppm. That notice referenced a summary of the petition prepared by
Bayer CropScience, the registrant, which is available to the public in
the docket, http://www.regulations.gov.
    Based upon review of the data supporting the petition, EPA
recalculated a maximum reasonable dietary burden (MRDB) for cattle that
is lower than used previously. No changes are required in the
established tolerances for milk or livestock commodities for this
petition.
    Comments were received on the notice of filing. EPA's response to
these comments is discussed in Unit IV.C.

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 combined residues of propoxycarbazone and its Pr-2-OH
metabolite on grass, forage and grass, hay at 20 ppm and 25 ppm,
respectively. EPA's assessment of exposures and risks associated with
establishing tolerances 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.
    Propoxycarbazone has low acute toxicity via the oral, dermal, and
inhalation routes. It is not an eye or dermal irritant or a dermal
sensitizer. No toxicity was seen at the limit dose in a 28-day dermal
toxicity study in rats. The main target organ appears to be the
gastrointestinal (GI) tract (gastric irritation), with irritation
observed in the 2-generation reproduction toxicity study in rats,
developmental toxicity study in rabbits, and the 90-day feeding study
in rats. In the 64-day and 1-year toxicity studies in dogs, no toxicity
was observed at doses >=1,181 milligram/kilogram/day (mg/kg/day) and,
>=605 mg/kg/day, respectively. Increased incidence of gastric
irritation was observed at a very high-dose (limit dose) in a 90-day
feeding study in rats. In a combined chronic toxicity/carcinogenicity
study in rats, decreased body weight, increased urinary pH and
histopathological changes in the kidney, indicate the kidney as the
target organ. An effect on body weight was evident in both subchronic
and chronic toxicity studies in mice.
    There was no evidence of neurotoxicity in any study. No
quantitative or qualitative evidence of increased susceptibility was
seen following in utero exposure to rats or rabbits in developmental
toxicity studies. No quantitative or qualitative evidence of increased
susceptibility was seen following the prenatal or postnatal exposure to
rats in a 2-generation reproduction toxicity study in rats. No evidence
of carcinogenicity was observed in a carcinogenicity study in mice at
doses up to the limit dose. In a chronic toxicity/carcinogenicity study
in rats, there was an increase in the incidence of mononuclear cell
leukemia (MNCL) in mid- and high-dose males; however, EPA concluded
that MNCL was not treatment-related. Propoxycarbazone has been
classified as ``not likely to be carcinogenic to human'' based on lack
of carcinogenicity in mice and rats and negative findings in various
mutagenicity assays.
    Specific information on the studies received and the nature of the
adverse effects caused by propoxycarbazone as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document Propoxycarbazone-sodium; Human-

Health Risk Assessment for Proposed Section 3 New Use on Pasture and
Rangeland Grasses at page 12 in docket ID number EPA-HQ-OPP-2008-0065
and in the Federal Register of July 7, 2004 (69 FR 40774) (FRL-7365-7).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effect of concern are identified (the LOAEL) or a
Benchmark Dose (BMD) approach is sometimes used for risk assessment.
Uncertainty/safety factors (UFs) are used in conjunction with the POD
to take into account uncertainties inherent in the extrapolation from
laboratory animal data to humans and in the variations in sensitivity
among members of the human population as well as other unknowns. Safety
is assessed for acute and chronic dietary risks by comparing aggregate
food and water exposure to the pesticide to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD are calculated by dividing the POD by all applicable UFs.
Aggregate short-term, intermediate-term, and chronic-term risks are
evaluated by comparing food, water, and residential exposure to the POD
to ensure that the margin of exposure (MOE) called for by the product
of all applicable UFs is not exceeded. This latter value is referred to
as the Level of Concern (LOC).
    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
greater than that 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 propoxycarbazone used
for human risk assessment can be found at http://www.regulations.gov in
document Propoxycarbazone-sodium; Human-Health Risk Assessment for
Proposed Section 3 New Use on Pasture and Rangeland Grasses at page 12
in docket ID number EPA-HQ-OPP-2008-0065 and in the Federal Register of
July 7, 2004 (69 FR 40774) (FRL-7365-7).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to propoxycarbazone, EPA considered exposure under the
petitioned-for tolerances as well as all existing propoxycarbazone
tolerances in (40 CFR 180.600). EPA assessed dietary exposures from
propoxycarbazone in food 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.
    No such effects were identified in the toxicological studies for
propoxycarbazone; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA assumed that tolerance-level
residues were for all food commodities at current or proposed
propoxycarbazone tolerances, and that 100% of the crops included in the
analysis were treated.
    iii. Cancer. The Agency has determined that propoxycarbazone is
``not likely to be a carcinogenic to humans'' based on the lack of
evidence of carcinogenicity in mice and rats and no mutagenicity
concerns. Therefore, a quantitative exposure assessment to evaluate
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for propoxycarbazone. Tolerance level residues and/
or 100% crop treated (CT) were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for propoxycarbazone in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of propoxycarbazone. 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.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of propoxycarbazone for
chronic exposures for non-cancer assessments are estimated to be 1.79
parts per billion (ppb) for surface water and 0.36 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 1.79 ppb was used to
assess the contribution to drinking water.
    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).
    Propoxycarbazone is not registered for any specific use patterns
that would result in residential exposure.
    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 propoxycarbazone to share a common mechanism of
toxicity with any other substances, and propoxycarbazone does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
propoxycarbazone 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. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of rat or rabbit fetuses to in utero exposure
to propoxycarbazone. In the rat developmental toxicity study, no
developmental or maternal toxicity was observed at doses up to 1,000
mg/kg/day (limit dose). In the developmental toxicity study in rabbits,
developmental effects (abortion, post-implantation loss) were seen at a
higher dose (limit dose) than the maternally toxic dose. There is no
qualitative and/or quantitative evidence of increased susceptibility to
propoxycarbazone following prenatal or postnatal exposure in a 2-
generation reproduction study in rats. Although propoxycarbazone caused
increased post implantation loss and decreased live litter size in the
F2 litters at a dose level of 1,230.7-1,605.3 mg/kg/day, EPA did not
consider this as evidence for increased susceptibility since it
occurred in the presence of severe maternal toxicity (histopathological
lesions in the stomach) and only at doses above the limit dose.
    3. Conclusion. EPA has determined that reliable data show 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 toxicity database for propoxycarbazone is complete, except
for immunotoxicity testing. EPA began requiring functional
immunotoxicity testing of all food and non-food use pesticides on
December 26, 2007. Since this requirement went into effect well after
the tolerance petition was submitted, these studies are not yet
available for propoxycarbazone. In the absence of specific
immunotoxicity studies, EPA has evaluated the available
propoxycarbazone toxicity data to determine whether an additional
database uncertainty factor is needed to account for potential
immunotoxicity. There was no evidence of adverse effects on the organs
of the immune system in any study with propoxycarbazone. In addition,
propoxycarbazone does not belong to a class of chemicals (e.g., the
organotins, heavy metals, or halogenated aromatic hydrocarbons) that
would be expected to be immunotoxic. Based on these considerations, EPA
does not believe that conducting a special series (Harmonized Guideline
870.7800) immunotoxicity study will result in a point of departure less
than the NOAEL of 74.8 mg/kg/day used in calculating the cPAD for
propoxycarbazone; therefore, an additional database uncertainty factor
is not needed to account for potential immunotoxicity.
    ii. There is no indication that propoxycarbazone is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that propoxycarbazone results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to propoxycarbazone in drinking water. These
assessments will not underestimate the exposure and risks posed by
propoxycarbazone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
propoxycarbazone is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
propoxycarbazone from food and water will utilize less than 1% of the
cPAD for (children 1 to 2 years old) the population group receiving the
greatest exposure. There are no residential uses for propoxycarbazone.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Propoxycarbazone is not registered for any use patterns that would
result in residential exposure. Therefore, the short-term aggregate
risk is the sum of the risk from exposure to propoxycarbazone through
food and water and will not be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Propoxycarbazone is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to propoxycarbazone through food and water, which has already been
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Propoxycarbazone is
classified as ``not likely to be a carcinogenic to humans'' based on
the lack of evidence of carcinogenicity in mice and rats and no
mutagenicity concerns. Therefore, propoxycarbazone is not expected to
pose a cancer risk to humans.
    6. 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 Propoxycarbazone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology--liquid chromatography with tandem
mass spectrometry detection (LC/MS/MS), is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no Codex, Canadian or Mexican maximum residue limits
established for propoxycarbazone.

C. Response to Comments

    Public comments were received from B. Sachau who objected to the
proposed tolerances because of the amounts of pesticides already
consumed and carried by the American population. She further indicated
that testing

conducted on animals have absolutely no validity and are cruel to the
test animals. B. Sachau's comments contained no scientific data or
evidence to rebut the Agency's conclusion that there is a reasonable
certainty that no harm will result from aggregate exposure to
propoxycarbazone, including all anticipated dietary exposures and all
other exposures for which there is reliable information. EPA has
responded to B. Sachau's generalized comments on numerous previous
occasions. January 7, 2005, (70 FR 1349)(FRL-7691-4); October 29, 2004,
(69 FR 63083) (FRL-7681-9).

V. Conclusion

    Therefore, tolerances are established for combined residues of
propoxycarbazone, methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-
1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl] benzoate and its Pr-2-OH
metabolite, methyl 2-[[[(4,5-dihydro-3-(2-hydroxypropoxy)-4-methyl-5-
oxo-1H-1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl] benzoate in or on
grass, forage and grass, hay at 20 ppm and 25 ppm.

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.

     February 12, 2009.
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 180.600 is amended by adding alphabetically the following
commodities to the table in paragraph (a)(1) to read as follows:

Sec.  180.600  Propoxycarbazone: tolerance for residue.

    (a) * * * (1) * * *

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Grass, forage.........................................                                                        20
Grass, hay............................................                                                        25
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. E9-4352 Filed 3-3-09; 8:45 am]