[Federal Register Volume 76, Number 14 (Friday, January 21, 2011)]
[Rules and Regulations]
[Pages 3840-3843]
[FR Doc No: 2011-1262]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[EPA-R03-OAR-2010-0574; FRL-9251-7]

Approval of One-Year Extension for Attaining the 1997 8-Hour
Ozone Standard for the Delaware, Maryland, and Pennsylvania Portions of
the Philadelphia-Wilmington-Atlantic City Moderate Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is extending the attainment date from June 15, 2010 to
June 15, 2011 for the Delaware, Maryland, and Pennsylvania portions of
the Philadelphia-Wilmington-Atlantic City nonattainment area
(Philadelphia Area), which is classified as moderate for the 1997 8-
hour ozone national ambient air quality standard (NAAQS). This
extension is based in part on air quality data recorded during the 2009
ozone season. Specifically, the Philadelphia Area's 4th highest daily
8-hour monitored ozone value during the 2009 ozone season is 0.084
parts per million (ppm) or less. Accordingly, EPA is revising the
tables concerning the 8-hour ozone attainment dates for the
Philadelphia Area in the States of Delaware and Maryland, and the
Commonwealth of Pennsylvania (the States). EPA is approving the
extension of the attainment date for the Delaware, Maryland, and
Pennsylvania portions of the Philadelphia Area in accordance with the
requirements of the Clean Air Act (CAA). EPA is approving the extension
of the attainment date for the New Jersey portion of the Philadelphia
Area in a separate rulemaking in this Federal Register.

DATES: Effective Date: This final rule is effective on February 22,
2011.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2010-0574. All documents in the docket are listed in
the http://www.regulations.gov Web site. Although listed in the
electronic docket, some information is not publicly available, i.e.,
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 either electronically through http://www.regulations.gov or in hard copy for public inspection during normal
business hours at the Air Protection Division, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103. Copies of the State submittal are available at the
Delaware Department of Natural Resources and Environmental Control, 89
Kings Highway, P.O. Box 1401, Dover, Delaware 19903; the Maryland
Department of the Environment, 1800 Washington Boulevard, Suite 705,
Baltimore, Maryland 21230; and the Pennsylvania Department of
Environmental Protection, Bureau of Air Quality Control, P.O. Box 8468,
400 Market Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Maria Pino,<PHONE_NUMBER>, or by e-
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On November 9, 2010 (75 FR 68736), EPA published a notice of
proposed rulemaking (NPR) for the States. The NPR proposed approval of
requests made by the States for a one-year attainment date extension
for the Philadelphia Area. The Philadelphia Area, which is classified
as moderate for the 1997 8-hour ozone NAAQS, consists of: Cecil County
in Maryland; Bucks, Chester, Delaware, Montgomery and Philadelphia
Counties in Pennsylvania; the entire State of Delaware; and Atlantic,
Burlington, Camden, Cape May, Cumberland, Gloucester, Mercer, Ocean,
and Salem Counties in New Jersey. Since this area was classified as a
moderate ozone nonattainment area, the statutory ozone attainment date,
as prescribed by section 181(a) of the CAA, is June 15, 2010. The
States requested that the attainment date be extended to June 15, 2011.
As previously stated, EPA is approving the extension of the attainment
date for the New Jersey portion of the Philadelphia Area in a separate
rulemaking notice in this Federal Register.
    Section 172(a)(2)(C) of subpart 1 of the CAA provides for EPA to
extend the attainment date for an area by one year if the State has
complied with all the requirements and commitments pertaining to the
area in the applicable implementation plan and no more than a minimal
number of exceedances of the NAAQS has occurred in the attainment year.
Up to two one-year extensions may be issued for a single nonattainment
area. Section 181(a)(5) of subpart 2 contains a similar provision for
the ozone NAAQS, but instead of providing for an extension where there
has been a ``minimal'' number of exceedances, it allows an extension
only if there is no more than one exceedance of the NAAQS in the year
preceeding the extension year. However, the language in section
181(a)(5) reflects the form of the 1-hour ozone NAAQS and not the 1997
8-hour ozone NAAQS. 40 CFR 51.907 sets forth how sections

172(a)(2)(C) and 181(a)(5) apply to an area subject to the 1997 8-hour
ozone NAAQS.
    EPA has determined that the requirements for a one-year extension
of the attainment date, as set out under 40 CFR 51.907, have been
fulfilled as follows:
    (1) The States have complied with all requirements and commitments
pertaining to the area in the applicable ozone implementation plan. The
applicable ozone implementation plans can be found at 40 CFR 52.420, 40
CFR 52.1070, 40 CFR 52.2020, for the States of Delaware, Maryland, and
Pennsylvania, respectively; and
    (2) the Philadelphia Area's 4th highest daily 8-hour monitored
value during the 2009 ozone season is 0.084 ppm or less.
    Therefore, EPA approves the States' attainment date extension
requests for the Delaware, Maryland, and Pennsylvania portions of the
Philadelphia Area. As a result, the charts in 40 CFR 81.308, 40 CFR
81.321, and 40 CFR 81.339 are being modified to reflect EPA's approval
of the States' attainment date extension request. Those charts are
entitled ``Delaware-Ozone (8-Hour Standard)'', ``Maryland-Ozone (8-Hour
Standard)'', and ``Pennsylvania-Ozone (8-Hour Standard)'',
respectively.
    In the Technical Support Document (TSD) for this action, EPA
evaluates the air quality monitoring data for the Philadelphia Area.
For details, please refer to EPA's TSD. Other specific requirements for
an attainment date extension and the rationale for EPA's proposed
action are explained in the NPR and will not be restated here. No
public comments were received on the NPR.

II. Final Action

    EPA is approving a 1-year attainment date extension, from June 15,
2010 to June 15, 2011, for the Delaware, Maryland, and Pennsylvania
portions of the Philadelphia Area, which is classified as moderate for
the 1997 8-hour ozone NAAQS.

III. Statutory and Executive Order Reviews

A. General Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not
have a substantial direct effect on one or more Indian tribes, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132 (64 FR 43255, August 10, 1999), because it
merely determines that each of two areas has attained a Federal
standard, and does not alter the relationship or the distribution of
power and responsibilities established in the CAA. This rule also is
not subject to Executive Order 13045 (62 FR 19885, April 23, 1997),
because it is not economically significant.
    This rule does not involve establishment of technical standards,
and thus, the requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.
As required by section 3 of Executive Order 12988 (61 FR 4729, February
7, 1996), in issuing this rule, EPA has taken the necessary steps to
eliminate drafting errors and ambiguity, minimize potential litigation,
and provide a clear legal standard for affected conduct. EPA has
complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by
examining the takings implications of the rule in accordance with the
``Attorney General's Supplemental Guidelines for the Evaluation of Risk
and Avoidance of Unanticipated Takings'' issued under the executive
order.
    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low income
populations in the United States.
    EPA has determined that this direct final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. The rulemaking does not affect the level of protection
provided to human health or the environment because extending the
attainment date does not alter the emission reduction measures that are
required to be implemented in the Philadelphia Area, which is
classified as moderate nonattainment for the 1997 8-hour ozone
standard. See 69 FR at 23909 (April 30 2004). Additionally, if the
Philadelphia Area were not granted an extension of its attainment date,
EPA's recourse would be to initiate a reclassification of the
Philadelphia Area from its current classification of moderate
nonattainment to serious nonattainment, pursuant to section 181(b)(2)
of the CAA. Because the Philadelphia Area was formerly a severe
nonattainment area under the revoked 1-hour ozone standard (see 56 FR
at 56773, November 6, 1991), it is required to continue to implement
severe area requirements pursuant to EPA's interpretation of ``anti-
backsliding'' provision of section 172(e) of the CAA. See 69 FR at
23973, April 30, 2004, South Coast Air Quality Management District v.
EPA, 472 F.3d 882 (D.C. Cir. 2006), modified and rehearing den., 489
F.3d 1245 (D.C. Cir. 2007). The severe area requirements are more
stringent than both the moderate and serious area requirements set
forth in Title I, Part D, Subpart 2 of the CAA. Therefore, even if EPA
were to not grant the attainment date extension and instead move to
reclassify the area to serious nonattainment, no additional emission
reduction measures would be required to be implemented in the
Philadelphia Area through a 181(b)(2) reclassification. This action
does not impose an information collection burden under the provisions
of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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 the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by March 22, 2011. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action.
    This 1-year attainment date extension for the 1997 8-hour ozone
NAAQS for the Delaware, Maryland, and Pennsylvania portions of the
Philadelphia Area may not be challenged later in proceedings to enforce
its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: January 4, 2011.
W.C. Early,
Acting Regional Administrator, Region III.

    40 CFR part 81 is amended as follows:

PART 81--[AMENDED]

0
1. The authority citation for Part 81 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

0
2. In Sec.  81.308, the table entitled ``Delaware--Ozone (8-Hour
Standard)'' is revised to read as follows:

Sec.  81.308  Delaware.

* * * * *

                                                 Delaware--Ozone
                                                [8-Hour standard]
----------------------------------------------------------------------------------------------------------------
                                               Designation \a\                    Category/classification
         Designated area          ------------------------------------------------------------------------------
                                        Date \1\              Type              Date \1\              Type
----------------------------------------------------------------------------------------------------------------
Philadelphia-Wilmington-Atlantic
 Ci, PA-NJ-MD-DE:
    Kent County..................  ..................  Nonattainment.....  ..................  Subpart 2/
                                                                                Moderate.\2\
    New Castle County............  ..................  Nonattainment.....  ..................  Subpart 2/
                                                                                Moderate.\2\
    Sussex County................  ..................  Nonattainment.....  ..................  Subpart 2/
                                                                                Moderate.\2\
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is June 15, 2004, unless otherwise noted.
\2\ Attainment date extended to June 15, 2011.

* * * * *

0
3. In Sec.  81.321, the table entitled ``Maryland--Ozone (8-Hour
Standard)'' is amended by revising the entry for Philadelphia-Wilmin-
Atlantic Ci, PA-NJ-MD-DE (Cecil County) to read as follows:

Sec.  81.321  Maryland.

* * * * *

                                                 Maryland--Ozone
                                                [8-Hour standard]
----------------------------------------------------------------------------------------------------------------
                                               Designation \a\                    Category/classification
         Designated area          ------------------------------------------------------------------------------
                                        Date \1\              Type              Date \1\              Type
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Philadelphia-Wilmin-Atlantic Ci,
 PA-NJ-MD-DE:
    Cecil County.................  ..................  Nonattainment.....  ..................  Subpart 2/
                                                                                Moderate.\4\

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is June 15, 2004, unless otherwise noted.
\2\ Effective April 15, 2008.
\3\ November 22, 2004.
\4\ Attainment date extended to June 15, 2011.

* * * * *

0
4. In Sec.  81.339, the table entitled ``Pennsylvania--Ozone (8-Hour
Standard)'' is amended by revising the entry for Philadelphia-
Wilmington-Atlantic City, PA-NJ-MD-DE (Bucks County, Chester County,
Delaware County, Montgomery County, Philadelphia County) to read as
follows:

Sec.  81.339  Pennsylvania.

* * * * *

                                               Pennsylvania--Ozone
                                                [8-Hour standard]
----------------------------------------------------------------------------------------------------------------
                                               Designation \a\                    Category/classification
         Designated area          ------------------------------------------------------------------------------
                                        Date \1\              Type              Date \1\              Type
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Philadelphia-Wilmington-Atlantic
 City, PA-NJ-MD-DE:
    Bucks County.................  ..................  Nonattainment.....  ..................  Subpart 2/
                                                                                Moderate.\3\
    Chester County...............  ..................  Nonattainment.....  ..................  Subpart 2/
                                                                                Moderate.\3\
    Delaware County..............  ..................  Nonattainment.....  ..................  Subpart 2/
                                                                                Moderate.\3\
    Montgomery County............  ..................  Nonattainment.....  ..................  Subpart 2/
                                                                                Moderate.\3\
    Philadelphia County..........  ..................  Nonattainment.....  ..................  Subpart 2/
                                                                                Moderate.\3\

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is June 15, 2004, unless otherwise noted.
\2\ November 22, 2004.
\3\ Attainment date extended to June 15, 2011.

* * * * *
[FR Doc. 2011-1262 Filed 1-20-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 18 (Thursday, January 27, 2011)]
[Notices]
[Page 4893]
[FR Doc No: 2011-1722]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13763-000; Project No. 13772-000]

FFP Missouri 13, LLC, Grays Hydro, LLC; Notice Announcing
Preliminary Permit Drawing

January 20, 2011.
    On May 18, 2010, at 8:30 a.m., the Commission received two
preliminary permit applications for proposed projects to be located at
the Grays Landing Lock & Dam located on the Monongahela River in Greene
County, Pennsylvania.\1\ The applications were filed by FFP Missouri
13, LLC, for Project No. 13763-000, and Grays Hydro, LLC, for Project
No. 13772-000.
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    \1\ The Commission is open each day from 8:30 a.m. to 5 p.m.,
except Saturdays, Sundays, and holidays. 18 CFR 375.101(c) (2010).
The applications were filed between 5 p.m. on Monday May 17, 2010,
and 8:30 a.m. on Tuesday May 18, 2010. Under the Commission's Rules
of Practice and Procedure, any document received after regular
business hours is considered filed at 8:30 a.m. on the next regular
business day. 18 CFR 385.2001(a)(2) (2010).
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    Where all permit applicants are municipalities or all permit
applicants are non-municipalities, and no applicant's plans are better
adapted than the others' to develop, conserve, and utilize in the
public interest the water resources of a region, the Commission issues
a permit to the applicant who filed first in time.\2\ In this case,
because two applications from entities not claiming municipal
preference are deemed filed at the same time, the Commission will
conduct a random tie breaker to determine priority. In the event that
the Commission concludes that neither applicant's plans are better
adapted than the other, priority will be determined accordingly.
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    \2\ 18 CFR 4.37 (2010). See, e.g., BPUS Generation Development,
LLC, 126 FERC ] 61,132 (2009).
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    On January 27, 2011, at 10 a.m. (eastern time), the Secretary of
the Commission, or her designee, will, by random drawing, determine the
filing priority for the two applicants identified in this notice. The
drawing is open to the public and will be held in room 2C, the
Commission Meeting Room, located at 888 First St., NE., Washington, DC
20426. The results of the drawing will be recorded by the Secretary or
her designee. A subsequent notice will be issued by the Secretary
announcing the results of the drawing.

Kimberly D. Bose,
Secretary.
[FR Doc. 2011-1722 Filed 1-26-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 126 (Friday, June 29, 2012)]
[Notices]
[Page 38802]
[FR Doc No: 2012-16048]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9695-3]

Notification of Closed Meeting of the Science Advisory Board's
Scientific and Technological Achievement Awards Committee

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The U.S. Environmental Protection Agency's (EPA), Science
Advisory Board (SAB) Staff Office announces a meeting of the SAB's
Scientific and Technological Achievement Awards (STAA) Committee to
discuss SAB recommendations regarding the Agency's 2012 STAA
recipients. The SAB meeting will be closed to the public.

DATES: The SAB meeting dates are Monday and Tuesday, July 23 and 24,
2012, from 8:00 a.m. to 6:00 p.m. (Eastern Time).

ADDRESSES: The closed SAB meeting will be held at the EPA Potomac Yard
Conference Center, South Building, 2777 S. Crystal Drive, Arlington, VA
22202.

FOR FURTHER INFORMATION CONTACT: Members of the public who wish to
obtain further information regarding this announcement may contact Mr.
Edward Hanlon, Designated Federal Officer, by telephone:<PHONE_NUMBER>
or email at<EMAIL_ADDRESS>The SAB Mailing address is: U.S. EPA
Science Advisory Board (1400R), U.S. Environmental Protection Agency,
1200 Pennsylvania Avenue NW., Washington, DC 20460. General information
about the SAB concerning the SAB meeting announced in this notice may
be found on the SAB Web site at http://www.epa.gov/sab.

SUPPLEMENTARY INFORMATION:
    Summary: Pursuant to Section 10(d) of the Federal Advisory
Committee Act (FACA), 5 U.S.C. App.2, and section (c)(6) of the
Government in the Sunshine Act, 5 U.S.C. 552b(c)(6), EPA has determined
that the SAB meeting will be closed to the public. The purpose of the
SAB meeting is for the Committee to discuss recommendations for the SAB
regarding the recipients of the Agency's 2012 Scientific and
Technological Achievement Awards. These awards are established to honor
and recognize EPA employees who have made outstanding contributions in
the advancement of science and technology through their research and
development activities, as exhibited in publication of their results in
peer reviewed journals. I have determined that the SAB meeting will be
closed to the public because it is concerned with selecting employees
deserving of awards. In making these recommendations, the Agency
requires full and frank advice from the SAB. This advice will involve
professional judgments on the relative merits of various employees and
their respective work. Such personnel matters involve the discussion of
information that is of a personal nature and the disclosure of which
would be a clearly unwarranted invasion of personal privacy and,
therefore, are protected from disclosure by section (c)(6) of the
Government in the Sunshine Act, 5 U.S.C. 552b(c)(6). Minutes of the SAB
meeting will be kept and certified by the Chair.

    Dated: June 22, 2012.
 Lisa P. Jackson,
Administrator.
[FR Doc. 2012-16048 Filed 6-28-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Pages 12826-12827]
[FR Doc No: 2013-04243]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-1999-6254]

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by a document
dated December 21, 2012, Santa Clara Valley Transportation Authority
(VTA) has petitioned the Federal Railroad Administration (FRA) for an
extension of a waiver of compliance from certain provisions of the
Federal railroad safety regulations. FRA assigned the petition Docket
Number FRA-1999-6254.
    VTA's 42.2-mile light rail transit (LRT) system began service in
December 1987. The initial 9-mile segment from Santa Clara through
downtown San Jose, CA, was completed in June 1988. By April 1991, VTA
had extended its service to a 20.8-mile LRT system with 33 stations and
11 park-and-ride lots.
    In December 1999, VTA began operations on its 7.6-mile Tasman West
Extension, which connects Mountain View, CA, with VTA's existing light
rail line. The Tasman East Extension followed in two phases. Phase I,
which provides LRT service from VTA's Baypointe Transfer Station to its
I-880/Milpitas Station, was completed in May 2001. Phase II, which
provides LRT service from VTA's I-880/Milpitas Station to its Hostetter
Station, was completed in June 2004, in conjunction with the Capitol
Light Rail Extension south of Hostetter Station to Alum Rock Station.
On October 1, 2005, VTA's Vasona Extension--which runs from downtown
San Jose, CA, to the Winchester Transit Center--began service.
    The Vasona Extension is an LRT line that features ``limited
connections'' to the general railroad system of transportation due to a
shared corridor of operation with Union Pacific Railroad (UP).
Specifically, the Vasona Extension includes 5 miles of an existing 15-
mile long freight railroad industrial lead that is serviced by UP. VTA
owns the 5-mile section of track along the shared corridor with UP. VTA
and UP maintain an Operations and Maintenance Agreement (Agreement),
which includes an exclusive operating easement for UP. The Agreement
allows UP to fulfill its common carrier obligation to operate freight
service along the shared corridor. This Agreement also requires VTA to
inspect, maintain, and repair all track, signal systems, and automatic
warning devices along the shared corridor. UP's freight operations are
minimal and limited to daylight hours, with a maximum authorized speed
of 10 mph.
    By letter dated September 26, 2005, FRA granted VTA partial relief
from certain provisions of the Federal railroad safety regulations for
VTA's operations on the Vasona Extension. In a July 11, 2011, letter,
VTA requested that FRA extend the terms and conditions of the waivers
for another 5 years. FRA's subsequent reply letter, dated November 16,
2011, denied the requested 5-year extension, citing ``certain instances
of noncompliance by [VTA] with applicable FRA safety regulations.''
Instead, FRA granted VTA an 18-month extension of the waivers, with the
possibility of a further extension, subject to VTA addressing FRA's
safety concerns.
    In a December 21, 2012, letter, VTA requested that FRA extend the
terms and conditions of the subject waivers for another 5 years. VTA
states that it has worked diligently to address the issues raised by
FRA in its November 16, 2011, reply letter. Since 2011, VTA has written
to and met with FRA officials to clarify specific areas of concern, as
well as to obtain guidance on complying with the applicable FRA
regulations. VTA maintains that as a result of the discussions with
FRA, it has implemented a number of changes to address FRA's concerns
and to achieve full regulatory compliance. VTA therefore believes that
it is appropriate to request, and for FRA to grant, a 5-year extension
of the waivers.
    VTA also falls under the safety oversight of the California Public
Utilities Commission, which is authorized by the Federal Transit
Administration. See Statement of Agency Policy Concerning Jurisdiction
Over the Safety of Railroad Passenger Operations and Waivers Related to
Shared Use of the Tracks of the General Railroad System by Light Rail
and Conventional Equipment, 65 FR 42529 (July 10, 2000). See also Joint
Statement of Agency Policy Concerning Shared Use of the Tracks of the
General Railroad System by Conventional Railroads and Light Rail
Transit Systems, 65 FR 42626 (July 10, 2000).
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov/. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m.

and 5 p.m., Monday through Friday, except Federal Holidays.
    Communications received by April 11, 2013 will be considered by FRA
before final action is taken. Comments received after that date will be
considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
See http://www.regulations.gov/#!privacyNotice for the privacy notice
of regulations.gov or interested parties may review DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

    Issued in Washington, DC, on February 20, 2013.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2013-04243 Filed 2-22-13; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Rules and Regulations]
[Pages 10968-10976]
[FR Doc No: 2012-4321]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0364; FRL-9336-9]

Fluopyram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fluopyram in or on multiple commodities which are identified and
discussed later in this document. Bayer Crop Science requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 24, 2012. Objections and
requests for hearings must be received on or before April 24, 2012, 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-2009-0364. 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: Lisa Jones, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 308-9424; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the
harmonized test guidelines referenced in this document electronically,
please go to http://www.epa.gov/ocspp and select ``Test Methods and
Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0364 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
April 24, 2012. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2009-0364, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200

Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of January 6, 2010 (75 FR 864) (FRL-8801-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of two pesticide petitions (PP
8F7358 and 8F7463) by Bayer Crop Science, 2.T.W. Alexander Drive,
Research Triangle Park, NC 27709.
    Petition 8F7358 requested that 40 CFR part 180 be amended by
establishing tolerances on residues of the fungicide, fluopyram, N-[2-
[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-
(trifluoromethyl)benzamide, including its metabolites and degradates in
or on the following commodities: Grape at 2.0 parts per million (ppm);
strawberry at 2.0 ppm; and tomato at 1.0 ppm. A subsequent petition
8F7463 requested that 40 CFR part 180 be amended by establishing
additional tolerances on residues of the fungicide, fluopyram, N-[2-[3-
chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-
(trifluoromethyl)benzamide, including its metabolites and degradates in
or on the following commodities: Alfalfa, forage at 0.25 ppm; alfalfa,
hay at 0.80 ppm; almond, hulls at 8.0 ppm; apple, wet pomace at 2.5
ppm; artichoke at 2.0 ppm; banana at 1.0 ppm; beet, sugar, roots at
0.10 ppm; berry, low growing, subgroup 13-07G at 2.0 ppm; Brassica,
head and stem, subgroup 5A at 3.0 ppm; Brassica, leafy greens, subgroup
5B at 35 ppm; bushberries, subgroup 13-07B at 10 ppm; caneberries,
subgroup 13-07A at 5.0 ppm; citrus, oil at 10 ppm; corn, sweet, kernel
plus cob with husk removed at 0.10 ppm; cotton, gin byproducts at 0.05
ppm; cotton, undelinted seed at 0.10 ppm; fruit, citrus, group 10 at
1.0 ppm; fruit, pome, group 11 at 1.0 ppm; fruit, small, vine,
climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; fruit,
stone, group 12 at 2.0 ppm; grain, cereal, forage, fodder and straw,
group 16, except rice, forage at 8.0 ppm; grain, cereal, forage, fodder
and straw, group 16, except rice, hay, straw and stover at 14 ppm;
grain, cereal, forage, fodder and straw, group 16, except rice,
aspirated fractions at 50 ppm; grain, cereal, group 15, except rice and
sweet corn at 3.0 ppm; grape, raisin at 3.5 ppm; grass, forage, fodder
and hay, group 17, forage at 80 ppm; grass, forage, fodder and hay,
group 17, hay at 30 ppm; herbs, subgroup 19A, fresh at 50 ppm; herbs,
subgroup 19A, dried at 260 ppm; hop, dried cones at 100 ppm; nut, tree,
group (including pistachio) 14 at 0.05 ppm; okra at 8.0 ppm; oilseed,
group 20, except cotton at 5.0 ppm; onion, bulb, subgroup 3-07A at 0.30
ppm; onion, green, subgroup 3-07B at 20 ppm; peanut at 0.05 ppm;
peanut, hay at 50 ppm, pepper, non-bell at 8.0 ppm; potato, processed
potato waste at 0.15 ppm; soybean, aspirated fractions at 70 ppm;
soybean, forage at 8.0 ppm; soybean, hay at 30 ppm; soybean, hulls at
0.40 ppm; soybean, seed at 0.30 ppm; spices, except black pepper,
subgroup 19B at 100 ppm; vegetable, cucurbit, group 9 at 1.0 ppm;
vegetable, foliage of legume, except soybean, subgroup 7A, forage at 30
ppm; vegetable, foliage of legume, except soybean, subgroup 7A, hay at
75 ppm; vegetable, foliage of legume, except soybean, subgroup 7A,
vines at 16 ppm; vegetable, fruiting, except non-bell pepper, group 8
at 1.0 ppm; vegetable, leafy, except Brassica, group 4 at 35 ppm;
vegetable, leaves of root and tuber, group 2 at 30 ppm; vegetable,
legume, edible podded, subgroup 6A at 2.0 ppm; vegetable, legume,
succulent shelled, subgroup 6B at 0.20 ppm; vegetable, pea and bean,
dried shelled (except soybean), subgroup 6C at 0.50 ppm; vegetable,
root and tuber, except sugar beet, subgroup 1B at 0.50 ppm; and
vegetable, tuberous and corm, subgroup 1C at 0.05 ppm.
    This petition (8F7463) also requested that 40 CFR part 180 be
amended by establishing tolerances on residues of the fungicide,
fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-
(trifluoromethyl)benzamide, including its metabolites and degradates,
in or on the following commodities: Cattle, fat at 0.10 ppm; cattle,
meat at 0.10 ppm; cattle, meat byproducts, except liver at 0.10 ppm;
cattle, liver at 1.2 ppm; eggs at 0.1 ppm; goat, fat at 0.10 ppm; goat,
meat at 0.10 ppm; goat, meat byproducts, except liver at 0.10 ppm;
goat, liver at 1.2 ppm; hog, fat at 0.01 ppm; hog, meat at 0.01 ppm;
hog, meat byproducts, except liver at 0.01 ppm; hog, liver at 0.15 ppm;
horse, fat at 0.10 ppm; horse, meat at 0.10 ppm; horse, meat
byproducts, except liver at 0.10 ppm; horse, liver at 1.2 ppm, milk at
1.2 ppm; poultry, fat at 0.05 ppm; poultry, meat at 0.03 ppm; poultry,
meat byproducts at 0.20 ppm; sheep, fat at 0.10 ppm; sheep, meat at
0.10 ppm; sheep, meat byproducts, except liver at 0.10 ppm; and sheep,
liver at 1.2 ppm.
    That notice referenced a summary of the petitions prepared by Bayer
Crop Science, the registrant, which is available in the docket, http://www.regulations.gov.
    One comment was received from a private citizen who opposed the
manufacturing and selling of this product due to the lack of available
bee information. This comment is considered irrelevant because the
safety standard for approving tolerances under section 408 of the FFDCA
is directed solely at the safety of the pesticide residues in food to
the food consumer and does not permit consideration of environmental
effects on bees.
    Based upon review of the data supporting the petitions, EPA has
revised tolerance levels. Subsequently, the petitions have been further
modified per Bayer Crop Science's request to withdraw a majority of the
primary crops initially proposed for this action, and expanded the
original rotatable crops of alfalfa and cotton to include canola,
soybean, and cereals grains except rice, December 8, 2011 (76 FR 76676)
(FRL-9328-8). The reason for these changes is explained in Unit
IV.D.START.

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
fluopyram including exposure resulting from the tolerances established
by this action. EPA's assessment of exposures and risks associated with
fluopyram 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.
    Decreased body weight and liver effects were the common and
frequent findings in the fluopyram subchronic and chronic oral toxicity
studies in rats, mice, and dogs, and they appeared to be the most
sensitive effects. Liver effects were characterized by increased liver
weight, hepatocellular hypertrophy, hepatocellular vacuolation,
increased mitosis and hepatocellular necrosis. In the carcinogenicity
study, increased liver tumors were also observed in female rats. Liver
effects in rodents were seen at lower dose levels than those in the
dogs. Thyroid effects were found at dose levels similar to those that
produced liver effects in rats and mice; these effects consisted of
follicular cell hypertrophy, increased thyroid weight and hyperplasia
at dose levels greater than or equal to 100 milligrams/kilogram/day
(mg/kg/day). Changes in thyroid hormone levels were also seen in a
subchronic toxicity study. In male mice, there was an increased
incidence of thyroid adenomas.
    Fluopyram is classified as ``Likely to be Carcinogenic to Humans''
and a unit risk, Q1*, of 1.55 x 10-2 (mg/kg/
day)-1 was used for the linear low dose extrapolation of
cancer risk based on liver tumors in female rats; thyroid tumors were
also observed in male mice. Fluopyram is not genotoxic or mutagenic.
    Fluopyram is not a developmental toxicant, nor did it adversely
affect reproductive parameters. No evidence of qualitative or
quantitative susceptibility was observed in developmental studies in
rats and rabbits or in a multigeneration study in rats.
    In an acute neurotoxicity study, transient decreased motor activity
was seen only on the day of treatment, but no other findings
demonstrating neurotoxicity were observed. In addition, no
neurotoxicity was observed in the subchronic neurotoxicity study in the
presence of other systemic adverse effects. Fluopyram did not produce
treatment-related effects on the immune system.
    Fluopyram has low acute toxicity via the oral, dermal and
inhalation routes of exposure. Fluopyram is not a skin or eye irritant
or sensitizer under the conditions of the murine lymph node assay.
    Specific information on the studies received and the nature of the
adverse effects caused by fluopyram 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 the document ``Fluopyram: Human Health Risk
Assessment for Proposed Uses on Apples, Bananas (Import only), Cherries
(Sweet and Tart), Dried Beans, Peanuts, Potatoes, Strawberries, Sugar
Beets, Tree Nuts, Watermelon, and Wine Grapes'' beginning at Appendix
A, pages 41-47 in docket ID number EPA-HQ-OPP-2009-0364.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    The details for selecting toxicity endpoints and points of
departure for various exposure scenarios can be found at http://www.regulations.gov in the document ``Fluopyram: Human Health Risk
Assessment for Proposed Uses on Apples, Bananas (Import only), Cherries
(Sweet and Tart), Dried Beans, Peanuts, Potatoes, Strawberries, Sugar
Beets, Tree Nuts, Watermelon, and Wine Grapes'' in Appendix A on pages
47-66 in docket ID number EPA-HQ-OPP-2009-0364.
    A summary of the toxicological endpoints for fluopyram used for
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Fluopyram for Use in Human Health Risk Assessment
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                                                                          RfD, PAD, Level of       Study and
        Exposure/scenario         Point of departure   Uncertainty/ FQPA   concern for risk      toxicological
                                                        safety factors        assessment            effects
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Acute Dietary (General            NOAEL= 50 mg/kg/    UFA= 10X..........  aRfD = 0.50 mg/kg/  Acute
 Population, including Infants     day.               UFH=10X...........   day.                Neurotoxicity
 and Children).                                       FQPA SF=1X........  aPAD = 0.50 mg/kg/   Study in Rats.
                                                                           day.               The LOAEL of 100
                                                                                mg/kg in females
                                                                                is based on
                                                                                decreased motor
                                                                                and locomotor
                                                                                activity in
                                                                                females.
                                                                                The LOAEL in males
                                                                                was 125 mg/kg/
                                                                                day.
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Acute Dietary (Females 13-49      An endpoint attributable to a single dose exposure has not been identified for
 years of age).                    this subpopulation.
                                 -------------------------------------------------------------------------------
Chronic Dietary (All              NOAEL= 1.2 mg/kg/   UFA= 10X..........  cRfD = 0.012 mg/kg/ Combined Chronic/
 Populations).                     day.               UFH=..............   day.                Carcinogenicity
                                                      10X...............  cPAD = 0.012 mg/kg/  in Rats.
                                                      FQPA SF=1X........   day.               The LOAEL of 6.0
                                                                                mg/kg/day is
                                                                                based on
                                                                                follicular cell
                                                                                hypertrophy in
                                                                                the thyroid, and
                                                                                increased liver
                                                                                weight with gross
                                                                                pathological and
                                                                                histopathological
                                                                                findings.
                                 -------------------------------------------------------------------------------
Cancer (oral, dermal,             Based on the liver tumor in female rats, EPA classified fluopyram as a
 inhalation).                      ``Likely to be Carcinogenic to Human'' and recommended the use of linear low
                                   dose extrapolation model for risk assessment using a unit risk, Q1* = 1.55 x
                                   10-2 (mg/kg/day)-1.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose (a = acute, c = chronic). mg/kg/
  day = milligrams/kilogram/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluopyram, EPA considered exposure under the petitioned-for
tolerances. EPA assessed dietary exposures from fluopyram 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. Such effects were identified
for fluopyram. In estimating acute dietary exposure, EPA used food
consumption information from the U.S. Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). The acute dietary analysis included tolerance
residue levels, 100% crop treated assumption and processing factors
(empirical and default).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. The chronic dietary analysis included average residue
levels from crop field trials, 100% crop treated assumption, and
processing factors (empirical and default).
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
If quantitative cancer risk assessment is appropriate, cancer risk may
be quantified using a linear or nonlinear approach. If sufficient
information on the carcinogenic mode of action is available, a
threshold or non-linear approach is used and a cancer RfD is calculated
based on an earlier noncancer key event. If carcinogenic mode of action
data are not available, or if the mode of action data determines a
mutagenic mode of action, a default linear cancer slope factor approach
is utilized. Based on the data summarized in Unit III.A., EPA has
concluded that fluopyram should be classified as ``Likely to be
Carcinogenic to Humans'' and a linear approach has been used to
quantify cancer risk. The cancer dietary analysis included average
residue levels from crop field trials, processing factors (empirical
and default, commercial and household), and percent crop treated (PCT)
estimates.
    iv. Anticipated residue and PCT information. EPA used tolerance
level residues and assumed 100% crop treated in the acute dietary
assessment for fluopyram. For the chronic dietary assessment, EPA used
average residues from field trials and 100% CT information. The cancer
dietary risk assessment used average residues from field trials and
projected percent crop treated estimates based on processing factors.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the PCT for new uses as follows:

    Almonds: 33%; apples: 40%; barley: 22%; dry beans: 7%; cherry: 49%;
cotton: 7%; grapes: 79%; oats: 23%; peanuts: 67%; potatoes: 64%;
rapeseed: 73%; rye: 63%; sorghum: 12%; soybeans: 1%; strawberries: 71%;
sugar beets: 48%; watermelon: 54%; and wheat: 1%.
    EPA's estimate of the percent crop treated for the new uses of
fluopyram represents the upper bound of use expected during the
pesticide's initial 5 years of registration; that is, the percent crop
treated for fluopyram is a threshold of use that EPA is reasonably
certain will not be exceeded for this registered use site. The percent
crop treated for use in the chronic dietary assessment is calculated as
the average percent crop treated of the market leader or leaders (i.e.,
the pesticides with the greatest percent crop treated) on that crop
over the 3 most recent years of available data. The percent crop
treated for use in the acute dietary assessment is the maximum observed
percent crop treated over the same period. Comparisons are only made
among pesticides of the same pesticide types (e .g., the market leader
for fungicides on the use crop is selected for comparison with a new
fungicide). The market leader included in the estimation may not be the
same for each year since different pesticides may dominate at different
times.
    To calculate these percent crop treated values, EPA used recent
data from the National Agricultural Statistics Service (NASS) 2002-
2006, and recent proprietary data (2006-2010). The estimates for the
primary crops are based on the market leader approach involving several
registered fungicides, and the estimates for the rotational crops are
based on acres of wheat, corn, sorghum, barley, oats, rye, millet,
soybeans, canola, cotton, and alfalfa grown relative to the total
acreage of dry beans and potatoes treated with fluopyram.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which fluopyram may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluopyram in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluopyram. 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.
    Environmental fate studies indicate that the parent fluopyram is
stable under environmental conditions. Reported half-lives range from
89 days in field and aqueous photolysis studies to >1,000 days in
aerobic/anaerobic water/sediment systems. Fluopyram is mobile in soil
and can therefore, be expected to occur in surface water runoff and/or
in ground water leachate. Upper-bound ground water estimates were
derived using the Tier I Screening Concentration in Ground Water (SCI-
GROW) model. Surface water estimates were partially refined by
incorporating a foliar degradation rate into the Tier II Pesticide Root
Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) model. The
foliar decay rate was calculated from field trial studies in which
residues were determined at various intervals following foliar
application; no rain or irrigation occurring during the study period.
All other inputs reflect high-end assumptions regarding application
rates and percent cropped area (PCA) in the watershed.
    Based on the Tier II PRZM/EXAMS and SCI-GROW models the estimated
drinking water concentrations (EDWCs) of fluopyram for acute exposures
are 13 parts per billion (ppb) for surface water and 0.32 ppb for
ground water. The EDWCs of fluopyram for chronic exposures for non-
cancer assessments are estimated to be 4.9 ppb for surface water and
0.32 ppb for ground water and the EDWCs of fluopyram chronic exposures
for cancer assessments are estimated to be 3.5 ppb for surface water
and 0.32 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value 13 ppb (1 in 10 year annual
peak) based on a maximum application rate of 0.446 lb ai/A/season
(cucumber) was used to access the contribution to drinking water. For
chronic dietary risk assessment, the water concentration of value 4.9
ppb (1 in 10 year annual mean) based on a maximum application rate of
0.356 lb active ingredient/Acre (a.i./A)/season (potato) was used to
access the contribution to drinking water. For cancer dietary risk
assessment, the water concentration of value 3.5 ppb (1 in 30 year
annual mean) based on a maximum application rate of 0.356 lb a.i./A/
season (potato) was used to access the contribution of 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). Fluopyram 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 fluopyram
to share a common mechanism of toxicity with any other substances, and
fluopyram does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that fluopyram 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 Web site
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 available developmental
toxicity studies in rats and rabbits and the multi-generation
reproduction in rats demonstrate no evidence of increased
susceptibility in the developing or young animals which were exposed
during prenatal or postnatal periods. Decreased fetal body weight was
observed at levels equal to or greater than the maternal LOAEL in both
rat and rabbit developmental studies. Likewise, body weight effects
were seen in offspring at levels equal to the parental LOAEL in the rat
2-generation reproductive toxicity study.
    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 fluopyram is complete and includes the
immunotoxicity study and neurotoxicity screening battery.
    ii. The fluopyram toxicology database did not demonstrate evidence
of neurotoxicity. Although transient decreases in motor and locomotor
activities in the acute neurotoxicity study on the day of treatment and
limited use of hind-limbs and reduced motor activity in the rat
chronic/carcinogenicity study were seen, there were no other associated
neurobehavioral or histopathology changes found in other studies in the
fluopyram toxicity database. The effects seen in the chronic/
carcinogenicity study were in the presence of increased mortality and
morbidity such as general pallor and appearance. Therefore, the reduced
motor activity and limited use of hind-limbs seen in these two studies
were judged to be the consequence of the systemic effects and not
direct neurotoxicity. There is no indication that fluopyram 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 fluopyram results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the multi-generation
reproduction study.
    iv. There are no residual uncertainties in the exposure database.
Although extended field rotational crop studies are required as a
condition of registration, the rotational crop tolerances used in the
dietary risk assessment are not expected to underestimate exposure
because they are based on crop residue results from direct foliar
treatment as opposed to residues taken up by plants through roots from
treated soil. The acute dietary exposure assessment was performed using
tolerance level residues for all crops whereas the chronic dietary
assessment included average field trial residue levels for all crops.
Both acute and chronic assessments assumed 100% crop treated and
incorporated empirical or default processing factors. The dietary
exposure assessment also assumed that all drinking water will contain
fluopyram at the highest EDWC levels modeled by the Agency for ground
or surface water. Residential exposures are not expected. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to fluopyram in drinking water. These
assessments will not underestimate the exposure and risks posed by
fluopyram.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fluopyram will occupy 8.8% of the aPAD for children 1 to 2 years
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluopyram from food and water will utilize 13% of the cPAD for children
1 to 2 years old, the population group receiving the greatest exposure.
There are no residential uses for fluopyram.
    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). Because no
short-term adverse effect was identified; fluopyram is not expected to
pose a short-term risk.
    A short-term adverse effect was identified; however, fluopyram is
not registered for any use patterns that would result in short-term
residential exposure. Short-term risk is assessed based on short-term
residential exposure plus chronic dietary exposure. Because there is no
short-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess short-term risk), no
further assessment of short-term risk is necessary, and EPA relies on
the chronic dietary risk assessment for evaluating short-term risk for
fluopyram.
    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). Because no intermediate-term effect was identified, fluopyram
is not expected to pose an intermediate-term risk. An intermediate-term
adverse effect was identified; however, fluopyram is not registered for
any use patterns that would result in intermediate-term residential
exposure. Intermediate-term risk is assessed based on intermediate-term
residential exposure plus chronic dietary exposure. Because there is no
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess short-term risk), no
further assessment of intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for fluopyram.
    5. Aggregate cancer risk for U.S. population. Using the exposure
assumptions described in this unit for the cancer risk assessment, EPA
has concluded that exposure to fluopyram from food and water will
result in a lifetime cancer risk of 2.9 x 10-6 for the
general U.S. population. EPA generally considers cancer risks in the
range of 1 in 1 million (1 x 10-6) or less to be negligible.
The precision which can be assumed for cancer risk estimates is best
described by rounding to the nearest integral order of magnitude on the
log scale; for example, risks falling between

3 x 10-7 and 3 x 10-6 are expressed as risks in
the range of 10-6. Considering the precision with which
cancer hazard can be estimated, the conservativeness of low-dose linear
extrapolation, and the rounding procedure described above, cancer risk
should generally not be assumed to exceed the benchmark level of
concern of the range of 10-6 until the calculated risk
exceeds approximately 3 x 10-6. This is particularly the
case where some conservatism is maintained in the exposure assessment.
    Although the fluopyram exposure risk assessment is refined, it
retains some conservatism due, among other things, to the use of field
trial data to estimate residues in food and the use of high-end
assumptions to estimate residues in water. Accordingly, EPA has
concluded the cancer risk from aggregate exposure to fluopyram falls
within the range of 1 x 10-6 and is thus negligible.
    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 fluopyram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The German multiresidue method DFG Method S 19, a gas
chromatography with mass selective detection (GC/MSD) method, has been
proposed for the enforcement of tolerances for fluopyram residues in or
on crop commodities, and a high performance liquid chromatography
method with tandem mass spectrometry detection (HPLC/MS/MS), Method
01079, has been proposed for the enforcement of tolerances for residues
of fluopyram and its metabolite, AE C656948-benzamide, in livestock
commodities. The validated limit of quantitation (LOQ) is 0.01 ppm for
each analyte in each matrix. The proposed enforcement method for plant
commodities (DFG Method S19) and livestock commodities (Method 01079)
are deemed adequate as enforcement methods. Adequate HPLC/MS/MS methods
were used for data collection for crop and livestock commodities. The
FDA multiresidue methods of PAM Vol. I are suitable for the
determination of fluopyram in non-fatty matrices (using Section 302),
but are not suitable for detection of AE C656948-benzamide residues.
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>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    Codex Maximum Residue Limits (CXLs) have been established for grape
at 2 ppm and dried grapes (raisins) at 5 ppm; milk at 0.07 ppm;
mammalian meat at 0.1 ppm, and edible offal mammalian (meat byproducts)
at 0.7 ppm. For the purpose of international harmonization, EPA is
establishing U.S. tolerances for wine grape at 2.0 ppm (raised from 1.4
ppm); milk at 0.07 ppm (raised from 0.06 ppm); and hog meat byproducts
at 0.70 ppm (raised from 0.45 ppm).
    The Codex MRL for grapes is based on field trials conducted in
Europe, and is calculated by rounding up of the statistically
determined 1.3 ppm to 2 ppm. A U.S. tolerance for dried grapes
(raisins) is not needed as the tolerance request is for wine-type
grapes only, which are not converted to raisins.
    Harmonization of recommended U.S. tolerances for meat and meat
byproducts (other than hog) with Codex MRLs cannot be achieved. The
Codex MRL for livestock is calculated on the basis of the diets listed
in Annex 6 of the 2009 JMPR Report (OECD Feedstuffs Derived from Field
Crops) and the use of a reasonable worst case diet/feed approach
(RWCF). The dietary burden was calculated using only grape pomace
residue and 20% contribution to the Australian dairy and beef cattle
diets. The U.S. tolerance was based on guidance ``Revisions of
Feedstuffs in (Table 1) OPPTS Test Guideline 860.1000'' and ``Guidance
on Constructing Maximum Reasonably Balanced Diets (MRBD)''. Based on
the U.S. livestock diets (which does not include grape pomace) and the
cattle feeding study, the meat byproduct (cattle, goat horse, sheep)
tolerances need to be set at 1.1 ppm, a higher level than the 0.7 Codex
MRL for edible offal. Similarly, the U.S. meat tolerances for these
animals need to be set higher than the Codex MRL (0.15 versus 0.1 ppm).

C. Revisions to Petitioned-For Tolerances

    Because the Agency's preliminary risk assessment of fluopyram
determined that aggregate exposure to fluopyram potentially exceeded
safe levels, the petitioner withdrew tolerance proposals and
registration requests for the following crops: Crop Group 1B Root
vegetable; 1C Tuberous and corm vegetable (except potatoes and
sugarbeet); Crop Group 2 Leaves of root and tuberous vegetables, Crop
subgroups 3-07A and B Bulb vegetables; Crop Group 4 Leafy vegetables;
Crop Group 5 Brassica; Crop Group 6A Edible legumes; Crop Group 6B
Succulent beans and peas; Crop Group 6C (part) Dried peas and some
dried beans, (except soybeans); Crop Group 7 Foliage of legume
vegetables; Crop Group 8 Fruiting vegetables; Crop Group 10 Citrus;
Crop Group 11 Pome fruit (except apple); Crop subgroups 13-07A and B
Caneberries and Bushberries; Crop subgroup 13-07F Vine fruit (except
wine grapes); Crop subgroup 13-07G Low growing berries (except
strawberry); Crop Group 15 Cereal Grains (except for rotational
purposes); Crop Group16 Forage Cereals (except for rotational
purposes); Crop Group17 Grasses grown for forage or seed; Crop Group18
Non grass animal feeds; Crop Group19 Herbs and Spices; Crop Group 20
Oilseeds (except canola); Hops; Globe artichoke; Christmas Trees; Turf;
and Ornamentals.
    The petitioner subsequently, submitted a revised registration
specifying uses only on the following crops: Apple; banana (no U.S.
registration); bean, dry; beet, sugar, root; cherry (sweet and tart);
grape, wine; nut tree crop group 14; peanut; pistachio; potatoes;
strawberry; and watermelon. Based on the available field trial data,
and NAFTA tolerance calculation procedures, the Agency recommended
appropriate tolerance levels for individual commodities as opposed to
levels proposed for crop groups. However, although the petitioner
proposed a tolerance for ``nut, tree, group 14 (including pistachio)''
at 0.05 ppm, EPA determined that separate tolerances must be
established for the tree nut crop group and pistachio because pistachio
is not at this time included in crop group 14. The available data
indicate that 0.05 ppm is an appropriate level for these tolerances.

    The petitioner has proposed tolerances for combined residues of
fluopyram and AE C656948-benzamide in egg; milk; the fat, meat, and
meat byproducts of poultry; and the fat, liver, meat, and meat
byproducts (except liver) of cattle, goat, hog, horse, and sheep. The
estimated livestock dietary burden and available feeding study data
indicate that most of the proposed tolerances for livestock commodities
are too low. In addition, EPA no longer establishes separate tolerances
for liver (it is accounted for in the meat byproducts of livestock
animals). Based on the NAFTA calculator, the Agency recommended higher
tolerances.
    The revised registration permits crop rotation to alfalfa, cotton,
canola, cereal grains (except rice), and soybean with certain
restrictions. However, extensive field rotational crop data for these
crops are not available. In the absence of sufficient rotational crop
data, highly conservative target crop residue data were used for
setting tolerance for rotational crops. The preference was to select an
intermediate level between the confined accumulation/limited field
rotational crop data and primary crop data for the target rotated crops
so as to discourage potential misuse (i.e., direct foliar application)
and provide adequate maximum residue levels for legal uses according to
label instructions. Thus, pending extensive field rotational crop data,
EPA recommends interim rotational crop tolerances be set at half of the
calculated primary crop tolerances with a PBI of 30 days.
    In addition, the Agency determined tolerances were not required for
the following petitioned commodities: Beet, sugar, tops; corn, sweet,
kernel plus cob with husk removed; grain, cereal, forage, fodder and
straw, group 16, except rice, aspirated fractions; and soybean hulls,
thus, these tolerances have been removed. Tolerances were not needed
for the following reasons: the tolerance for the commodity corn, sweet,
kernel plus cob with husk removed is covered under grain, cereal, group
15, except rice; Bayer withdrew their requests for tolerances for
grain, cereal, forage, fodder and straw, group 16, except rice;
aspirated fractions and soybean, hulls; and the sugar beet top
tolerance was withdrawn because sugar beet tops are no longer
considered a major livestock commodity.
    Moreover, EPA is revising certain crop definitions (as proposed)
for the following: almond, hulls; beet, sugar, roots; eggs; grain,
cereal, group 15, except rice and sweet corn. The correct commodity
terminology are almond, hull; beet, sugar, root; egg; and grain,
cereal, group 15, except rice, respectively.

V. Conclusion

    Therefore, tolerances are established for residues of fluopyram, in
or on multiple commodities as shown in the codified text below.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to petitions 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) (Pub. L. 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: February 2, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.

    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 180.661 is added to subpart C to read as follows:

Sec.  180.661  Fluopyram; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
fungicide Fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]ethyl]-2-(trifluoromethyl)benzamide, including its
metabolites and degradates in or on the commodities in the table below.
Compliance with the tolerance levels specified in the table is to be

determined by measuring only fluopyram in or on the commodity.

------------------------------------------------------------------------
                                                              Parts  per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hull...............................................         8.0
Apple......................................................         0.30
Apple, wet pomace..........................................         0.60
Banana \1\.................................................         1.0
Bean, dry..................................................         0.09
Beet, sugar, root..........................................         0.04
Cherry.....................................................         0.60
Grape, wine................................................         2.0
Nut, tree, group 14........................................         0.05
Peanut.....................................................         0.02
Pistachio..................................................         0.05
Potato.....................................................         0.02
Potato, processed potato waste.............................         0.08
Strawberry.................................................         1.5
Watermelon.................................................         1.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations.

    (2) Tolerances are established for residues of the fungicide
fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-
(trifluoromethyl)benzamide, including its metabolites and degradates.
Compliance with the tolerance levels specified in the table below is to
be determined by measuring only the sum of fluopyram and its
metabolite, 2-(trifluoromethyl)benzamide, calculated as the
stoichiometric equivalent of fluopyram, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................         0.11
Cattle, meat...............................................         0.15
Cattle, meat byproducts....................................         1.1
Egg........................................................         0.25
Goat, fat..................................................         0.11
Goat, meat.................................................         0.15
Goat, meat byproducts......................................         1.1
Hog, fat...................................................         0.05
Hog, meat..................................................         0.05
Hog, meat byproducts.......................................         0.70
Horse, fat.................................................         0.11
Horse, meat................................................         0.15
Horse, meat byproducts.....................................         1.1
Milk.......................................................         0.07
Poultry, fat...............................................         0.20
Poultry, meat..............................................         0.15
Poultry, meat byproducts...................................         0.60
Sheep, fat.................................................         0.11
Sheep, meat................................................         0.15
Sheep, meat byproducts.....................................         1.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. It is recommended that
tolerances be established for indirect or inadvertent residues of
fungicide fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]ethyl]-2-(trifluoromethyl)benzamide, including its
metabolites and degradates, in or on the commodities in the table
below. Compliance with the tolerance levels specified in the table is
to be determined by measuring only fluopyram in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................         0.45
Alfalfa, hay...............................................         1.1
Canola, seed...............................................         1.8
Cotton, gin byproducts.....................................         0.05
Cotton, undelinted seed....................................         0.01
Grain, cereal, forage, fodder and straw, group 16, except           4.0
 rice; forage..............................................
Grain, cereal, forage, fodder and straw, group 16, except           7.0
 rice; hay, straw and stover...............................
Grain, cereal, group 15, except rice.......................         1.5
Soybean, forage............................................         4.0
Soybean, hay...............................................        15
Soybean, seed..............................................         0.10
------------------------------------------------------------------------

[FR Doc. 2012-4321 Filed 2-23-12; 8:45 am]
BILLING CODE 6560-50-P