[Federal Register Volume 76, Number 136 (Friday, July 15, 2011)]
[Rules and Regulations]
[Pages 41653-41657]
[FR Doc No: 2011-17402]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-1307; Directorate Identifier 2010-NM-049-AD;
Amendment 39-16671; AD 2011-09-09]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Model CL-600-2A12 (CL-
601) and CL-600-2B16 (CL-601-3A, CL-601-3R, and CL-604 Variants)
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    During flight-testing of a wing anti-ice piccolo tube containing
a deliberate small breach, it was determined that the wing leading
edge thermal switches were not detecting the consequent bleed leak
at the design threshold. As a result, new

Airworthiness Limitation tasks, consisting of a functional test of
the wing leading edge thermal switches and an inspection of the wing
anti-ice duct piccolo tubes, have been introduced in order to limit
exposure to dormant failure of the switches in the event of piccolo
tube failure, which could potentially compromise the structural
integrity of the wing leading edge and the effectiveness of the wing
anti-ice system.

We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective August 19, 2011.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of August 19,
2011.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Cesar Gomez, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on January 5, 2011 (76
FR 477). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    During flight-testing of a wing anti-ice piccolo tube containing
a deliberate small breach, it was determined that the wing leading
edge thermal switches were not detecting the consequent bleed leak
at the design threshold. As a result, new Airworthiness Limitation
tasks, consisting of a functional test of the wing leading edge
thermal switches and an inspection of the wing anti-ice duct piccolo
tubes, have been introduced in order to limit exposure to dormant
failure of the switches in the event of piccolo tube failure, which
could potentially compromise the structural integrity of the wing
leading edge and the effectiveness of the wing anti-ice system. This
directive mandates the revision of the approved maintenance schedule
to include these new tasks, including phase-in schedules.
    This revision clarifies the applicability of the directive for
CL-600-2A12 aircraft, serial numbers 3001 through 3066, and for CL-
600-2B16 aircraft, serial numbers 5001 through 5194. The directive
is only applicable to these aircraft if Bombardier Service Bulletin
(SB) 601-0590 [Scheduled Maintenance Instructions (MSG-3) Derived--
Qualification] has been incorporated. There is no change required to
the approved maintenance schedule if SB 601-0590 has not been
incorporated.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect 103 products of U.S. registry.
We also estimate that it will take about 1 work-hour per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Based on these figures, we estimate the cost of
this AD to the U.S. operators to be $8,755, or $85 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect 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.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2011-09-09 Bombardier, Inc.: Amendment 39-16671. Docket No. FAA-
2010-1307; Directorate Identifier 2010-NM-049-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective August
19, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to the airplanes identified in paragraphs
(c)(1), (c)(2), (c)(3), and (c)(4) of this AD; certificated in any
category.
    (1) Bombardier, Inc. Model CL-600-2A12 (CL-601) airplanes,
serial numbers 3001 through 3066 inclusive on which Bombardier
Service Bulletin 601-0590 has been accomplished.
    (2) Bombardier, Inc. CL-600-2B16 (CL-601-3A and CL-601-3R
Variants) airplanes, serial numbers 5001 through 5194 inclusive on
which Bombardier Service Bulletin 601-0590 has been accomplished.
    (3) Bombardier, Inc. CL-600-2B16 (CL-604 Variants) airplanes,
serial numbers 5301 through 5665 inclusive.
    (4) Bombardier, Inc. CL-600-2B16 (CL-604 Variants) airplanes,
serial numbers 5701 and subsequent.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these inspections is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these inspections, the operator may not be able
to accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (j) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Subject

    (d) Air Transport Association (ATA) of America Codes 30 and 36:
Ice and Rain Protection and Pneumatic, respectively.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    During flight-testing of a wing anti-ice piccolo tube containing
a deliberate small breach, it was determined that the wing leading
edge thermal switches were not detecting the consequent bleed leak
at the design threshold. As a result, new Airworthiness Limitation
tasks, consisting of a functional test of the wing leading edge
thermal switches and an inspection of the wing anti-ice duct piccolo
tubes, have been introduced in order to limit exposure to dormant
failure of the switches in the event of piccolo tube failure, which
could potentially compromise the structural integrity of the wing
leading edge and the effectiveness of the wing anti-ice system.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Within 30 days after the effective date of this AD: Revise
the Airworthiness Limitations Section of the Instructions for
Continued Airworthiness by incorporating the applicable tasks
identified in table 1 of this AD.

                Table 1--Airworthiness Limitations Tasks
------------------------------------------------------------------------
                                      Incorporate
  For Bombardier, Inc. model--         task(s)--        Identified in--
------------------------------------------------------------------------
CL[dash]600[dash]2A12             30-11-00-101, Wing  Bombardier
 (CL[dash]601) airplanes, serial   Anti-icing, and     Challenger 601
 numbers 3001 through 3066         30-11-00-102,       Time Limits/
 inclusive on which Bombardier     Wing Anti-icing.    Maintenance
 Service Bulletin 601[dash]0590                        Checks, PSP 601-
 has been accomplished.                                5, Revision 38,
                                                       dated June 19,
                                                       2009.
CL[dash]600[dash]2B16             30-11-00-101, Wing  Bombardier
 (CL[dash]601[dash]3A and          Anti-icing, and     Challenger 601
 CL[dash]601[dash]3R Variants)     30-11-00-102,       Time Limits/
 airplanes, serial numbers 5001    Wing Anti-icing.    Maintenance
 through 5194 inclusive on which                       Checks, PSP 601A-
 Bombardier Service Bulletin 601-                      5, Revision 34,
 0590 has been accomplished.                           dated June 19,
                                                       2009.
CL-600-2B16 (CL-604 Variants)     30-11-00-101,       Bombardier
 airplanes, serial numbers 5301    Detailed            Challenger 604
 through 5665 inclusive.           Inspection of the   Time Limits/
                                   Wing Anti-Ice       Maintenance
                                   Duct Piccolo-       Checks, CH 604
                                   Tube, and           TLMC, Revision
                                   36[dash]21[dash]0   13, dated August
                                   0[dash]101,         12, 2009.
                                   Functional Test
                                   of the Leading
                                   Edge Thermal
                                   Switches.
CL-600-2B16 (CL-604 Variants)     30-11-00-101,       Bombardier
 airplanes, serial numbers 5701    Detailed            Challenger 605
 and subsequent.                   Inspection of the   Time Limits/
                                   Wing Anti-Ice       Maintenance
                                   Duct Piccolo-       Checks, CH 605
                                   Tube, and           TLMC, Revision 1,
                                   36[dash]21[dash]0   dated August 12,
                                   0[dash]101,         2009.
                                   Functional Test
                                   of the Leading
                                   Edge Thermal
                                   Switches.
------------------------------------------------------------------------

     (h) For all tasks identified in paragraph (g) of this AD, the
initial compliance times for those tasks are within the applicable
times specified in table 2 of this AD.

                      Table 2--Initial Compliance Times for Airworthiness Limitations Tasks
----------------------------------------------------------------------------------------------------------------
                                                                Initial compliance time
       Bombardier, Inc. model--               Task(s)--            (whichever occurs
                                                                        later)--
----------------------------------------------------------------------------------------------------------------
CL[dash]600[dash]2A12 (CL[dash]601)    30-11-00-101, Wing Anti- Prior to the             Within 240 flight hours
 airplanes, serial numbers 3001         icing.                   accumulation of 4,800    after the effective
 through 3066 inclusive; and                                     total flight hours; or   date of this AD.
 CL[dash]600[dash]2B16                                           within 4,800 flight
 (CL[dash]601[dash]3A and                                        hours after
 CL[dash]601[dash]3R Variants)                                   accomplishing Task
 airplanes, serial numbers 5001                                  30[dash]11[dash]06[das
 through 5194 inclusive; on which                                h]204 in Section
 Bombardier Service Bulletin 601-0590                            5[dash]20-15 of the
 has been accomplished.                                          applicable Time Limits/
                                                                 Maintenance Checks
                                                                 manual specified in
                                                                 table 1 of this AD;
                                                                 whichever occurs later.

CL[dash]600[dash]2A12 (CL[dash]601)    30-11-00-102, Wing Anti- Prior to the             Within 240 flight hours
 airplanes, serial numbers 3001         icing.                   accumulation of 4,800    after the effective
 through 3066 inclusive; and                                     total flight hours; or   date of this AD.
 CL[dash]600[dash]2B16                                           within 4,800 flight
 (CL[dash]601[dash]3A and                                        hours after
 CL[dash]601[dash]3R Variants)                                   accomplishing Task
 airplanes, serial numbers 5001                                  30[dash]13[dash]00[das
 through 5194 inclusive; on which                                h]205 in Section
 Bombardier Service Bulletin 601-0590                            5[dash]20-15 of the
 has been accomplished.                                          applicable Time Limits/
                                                                 Maintenance Checks
                                                                 manual specified in
                                                                 table 1 of this AD;
                                                                 whichever occurs later.
CL-600-2B16 (CL-604 Variants)          30-11-00-101, Detailed   Prior to the             Within 320 flight hours
 airplanes, serial numbers 5301         Inspection of the Wing   accumulation of 6,400    after the effective
 through 5665 inclusive.                Anti-Ice Duct Piccolo-   total flight hours;      date of this AD.
                                        Tube, and                except for airplanes
                                        36[dash]21[dash]00[das   having 6,400 total
                                        h]101, Functional Test   flight hours or more
                                        of the Leading Edge      as of the effective
                                        Thermal Switches.        date of this AD on
                                                                 which the task has not
                                                                 been accomplished:
                                                                 prior to the next
                                                                 scheduled 6,400 flight
                                                                 hour task inspection
                                                                 or prior to the next
                                                                 scheduled
                                                                 accomplishment of Task
                                                                 57[dash]10[dash]00-208
                                                                 in the applicable Time
                                                                 Limits/Maintenance
                                                                 Checks manual
                                                                 specified in table 1
                                                                 of this AD, whichever
                                                                 occurs first.
CL-600-2B16 (CL-604 Variants)          30-11-00-101, Detailed   Prior to the             Within 320 flight hours
 airplanes, serial numbers 5701 and     Inspection of the Wing   accumulation of 6,400    after the effective
 subsequent.                            Anti-Ice Duct Piccolo-   total flight hours.      date of this AD.
                                        Tube, and
                                        36[dash]21[dash]00[das
                                        h]101, Functional Test
                                        of the Leading Edge
                                        Thermal Switches.
----------------------------------------------------------------------------------------------------------------

    (i) After accomplishing the actions required by paragraph (g) of
this AD, no alternative tasks or task intervals may be used unless
the tasks or task intervals are approved as an alternative method of
compliance (AMOC) in accordance with the procedures specified in
paragraph (j)(1) of this AD.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (j) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the ACO, send it to ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
410, Westbury, New York 11590; telephone<PHONE_NUMBER>; fax 516-794-
5531. Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office. The AMOC approval letter must specifically
reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

Related Information

    (k) Refer to MCAI Canadian Airworthiness Directive CF-2009-49R1,
dated January 21, 2010, and the service information specified in
Table 1 of this AD, for related information.

Material Incorporated by Reference

    (l) You must use the applicable service information contained in
table 3 of this AD to do the actions required by this AD, unless the
AD specifies otherwise.

               Table 3--Material Incorporated by Reference
------------------------------------------------------------------------
           Document               Revision                Date
------------------------------------------------------------------------
Tasks 30-11-00-101, Wing Anti-             38  June 19, 2009.
 icing, and 30-11-00-102,
 Wing Anti-icing, of the
 Bombardier Challenger 601
 Time Limits/Maintenance
 Checks, PSP 601-5.
Tasks 30-11-00-101, Wing Anti-             34  June 19, 2009.
 icing, and 30-11-00-102,
 Wing Anti-icing, of the
 Bombardier Challenger 601
 Time Limits/Maintenance
 Checks, PSP 601A-5.
Tasks 30-11-00-101, Detailed               13  August 12, 2009.
 Inspection of the Wing Anti-
 Ice Duct Piccolo-Tube, and
 36-21-00-101, Functional
 Test of the Leading Edge
 Thermal Switches, of the
 Bombardier Challenger 604
 Time Limits/Maintenance
 Checks, CH 604 TLMC.
Tasks 30-11-00-101, Detailed                1  August 12, 2009.
 Inspection of the Wing Anti-
 Ice Duct Piccolo-Tube, and
 36-21-00-101, Functional
 Test of the Leading Edge
 Thermal Switches, of the
 Bombardier Challenger 605
 Time Limits/Maintenance
 Checks, CH 605 TLMC.
------------------------------------------------------------------------

    The title pages of these documents do not indicate the revision
level or issue date of the documents. Only the Record of Revisions
of these documents contains the revision level of these documents.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; e-mail<EMAIL_ADDRESS>Internet http://www.bombardier.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on April 13, 2011.
Ali Bahrami,
Manager,Transport Airplane Directorate,Aircraft Certification Service.

[FR Doc. 2011-17402 Filed 7-14-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Notices]
[Page 44900]
[FR Doc No: 2011-18917]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 Notice of Effectiveness of Exempt Wholesale; Generator Status

July 13, 2011.

Yuba City Cogeneration         Docket Nos. EG11-74-000
 Partners, LP.
Dempsey Ridge Wind Farm, LLC.  EG11-75-000
Howard Wind LLC..............  EG11-76-000
Highland North LLC...........  EG11-77-000
KES Kingsburg, LP............  EG11-78-000
Gila River Energy Supply LLC.  EG11-79-000

    Take notice that during the month of June 2011, the status of the
above-captioned entities as Exempt Wholesale Generators became
effective by operation of the Commission's regulations. 18 CFR
366.7(a).

    Dated: July 13, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-18917 Filed 7-26-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Rules and Regulations]
[Pages 32029-32034]
[FR Doc No: 2015-13818]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0265; FRL-9927-65]

n-Butyl benzoate; Exemptions From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of n-butyl benzoate (CAS Reg. No. 136-60-7)
when used as an inert ingredient (solvent) in pesticide formulations
applied to growing crops, raw agricultural commodities after harvest,
and animals and when used as an inert ingredient in antimicrobial
formulations in food-contact surface sanitizer products at a maximum
level in the end-use concentration of 15,000 parts per million (ppm).
Exponent, Inc., on behalf Huntsman Corp., submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting
establishment of an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of n-butyl benzoate.

DATES: This regulation is effective June 5, 2015. Objections and
requests for hearings must be received on or before August 4, 2015, 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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0265, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; 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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP 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-2014-0265 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
August 4, 2015. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0265, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at  http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of October 24, 2014 (Vol. 79 FR 63594)
(FRL-9916-03), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10682) by Exponent, Inc., 1150 Connecticut Ave. NW., Suite 1100,
Washington, DC 20035 on behalf Huntsman Corp., 8600 Gosling Road, The
Woodlands, TX 77381. The petition requested that 40 CFR 180.910,
180.930, and 180.940 be amended by establishing an exemption from the
requirement of a tolerance for residues of n-butyl benzoate (CAS Reg.
No. 136-60-7) when used as an inert ingredient (solvent) in pesticide
formulations applied to growing crops, raw agricultural commodities
after harvest, and animals and when used as an inert

ingredient in antimicrobial formulations in food-contact surface
sanitizer products. That document referenced a summary of the petition
prepared by Exponent, Inc., on behalf Huntsman Corp., the petitioner,
which is available in the docket, http://www.regulations.gov. No
tolerance-related comments were received on the notice of filing.
    Based on a review of the data submitted in support of this
petition, EPA has modified the exemption requested by limiting the
amount of n-butyl benzoate allowed in food contact sanitizing solutions
to a maximum 15,000 ppm (1.5%). This limitation is based on the
Agency's risk assessment which can be found at http://www.regulations.gov in document ``n-Butyl Benzoate; Human Health Risk
Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as an Inert
Ingredient in Pesticide Formulations,'' in docket ID number EPA-HQ-OPP-
2014-0265.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for 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. . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), 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 n-butyl benzoate including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with n-butyl benzoate
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
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. Specific information on the studies received and the nature
of the adverse effects caused by n-butyl benzoate as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this
unit.
    In acute oral, dermal, and inhalation toxicity studies in rats, n-
butyl benzoate was found to be slightly toxic to nontoxic. In primary
eye and dermal irritation studies in rabbits, n-butyl benzoate was
found to be minimally irritating. In a dermal sensitization study in
guinea pigs, n-butyl benzoate was not a dermal sensitizer.
    In a combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test, n-butyl benzoate was
administered daily to rats by gavage at doses of 0 (vehicle control),
250, 500 and 1,000 mg/kg bw/day. The NOAEL for parental toxicity was
1,000 mg/kg/day; the highest dose tested. The LOAEL for parental
toxicity was not observed in this study. The NOAEL for embryo-fetal
toxicity was 500 mg/kg bw/day based on increased pup mortality on post-
natal day zero observed at the LOAEL of 1,000 mg/kg/day.
    No positive mutagenic response was observed for n-butyl benzoate in
a reverse bacterial mutation assay.
    No chronic toxicity data for n-butyl benzoate are available.
    There are no cancer studies available for n-butyl benzoate. n-Butyl
benzoate is metabolized by esterase mediated hydrolysis resulting in
the formation of two major polar metabolites, n-butyl alcohol and
benzoic acid. Each metabolite enters other degradation pathways to be
rapidly metabolized and/or excreted. Based on predicted rapid
metabolism and excretion, the lack of specific target organ toxicity in
the OCSPP Harmonized Test Guideline 870.3650 study, the results of
genotoxicity testing being negative, and a Quantitative Structure
Activity Relationship (QSAR) expert model, DEREK Nexus, that indicates
no structural alerts for carcinogenicity, n-butyl benzote is not
expected to be carcinogenic.

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.
    1. Acute dietary (all populations). There were no adverse effects
observed attributable to a single dose for the general population
(including infants and children) or females 13-49 years of age.
    2. Chronic dietary (all populations). The chronic population
adjusted dose (cPAD) of 5 mg/kg/day is established based on the NOAEL
of 500 mg/kg/day from a combined repeated dose toxicity study with the
reproduction/developmental toxicity screening test in rats. The adverse
effects seen in this study were increased pup mortality observed at the
LOAEL of 1,000 mg/kg/day. The Food Quality Protection Act (FQPA) safety
factor/database uncertainty factor of 1X and 10X intra- and
interspecies uncertainty factors are utilized for dietary risk
assessment.
    3. Dermal, short- and intermediate-term. The level of concern (LOC)
for short- and intermediate-term dermal exposure is a margin of
exposure (MOE) of 100 and the assessment is based on the NOAEL (500 mg/
kg/day) from the combined repeated dose toxicity study with the
reproduction/developmental toxicity screening test in rats.
    4. Inhalation, short- and intermediate term. The LOC for short- and
intermediate-term inhalation exposure is a MOE of 100 and the
assessment is based on the NOAEL (500 mg/kg/day) from the combined
repeated dose toxicity study with the reproduction/developmental
toxicity screening test in rats.
    5. Quantification of cancer risk is not appropriate since there are
no concerns for cancer based on data that n-butyl benzoate is
metabolized by esterase mediated hydrolysis resulting in the formation
of two major polar metabolites, n-butyl alcohol and benzoic acid,
neither substance being a concern for cancer. In addition, there is a
lack of specific target organ toxicity in the OCSPP Harmonized Test
Guideline 870.3650 study, the results of genotoxicity testing for n-
butyl benzoate are negative, and QSAR expert model, DEREK Nexus,
indicates that there are no structural alerts for carcinogenicity. As
such, n-butyl benzote is not expected to be carcinogenic.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to n-butyl benzoate, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from n-butyl benzoate in food as follows:
    The Agency assessed the dietary exposures to n-butyl benzoate as an
inert ingredient for use in pesticide formulations applied to growing
crops, raw agricultural commodities, and livestock as well as an inert
ingredient for use in food-contact surface sanitizing solutions. In the
case of dietary exposures to n-butyl benzoate as an inert ingredient
used in pesticide formulations applied to growing crops, raw
agricultural commodities, and livestock, a chronic dietary exposure
assessment was conducted using the Dietary Exposure Evaluation Model/
Food Commodity Intake Database (DEEM-FCID)TM, Version 3.16. EPA used
food consumption information from the U.S. Department of Agriculture's
National Health and Nutrition Examination Survey, What We Eat in
America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to
2008. As to residue levels in food, no residue data were submitted for
n-butyl benzoate. In the absence of specific residue data, EPA has
developed an approach that uses surrogate information to derive upper
bound exposure estimates for the subject inert ingredient. Upper bound
exposure estimates are based on the highest tolerance for a given
commodity from a list of high-use insecticides, herbicides, and
fungicides. A complete description of the general approach taken to
assess inert ingredient risks in the absence of residue data is
contained in the memorandum entitled ``Alkyl Amines Polyalkoxylates
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water)
Dietary Exposure and Risk Assessments for the Inerts.'' (D361707, S.
Piper, 2/25/09) and can be found at http://www.regulations.gov in
docket ID number EPA-HQ-OPP-2008-0738.
    In the case of the proposed use of n-butyl benzoate as an inert
ingredient in food-contact sanitizing pesticide products, EPA has
utilized a conservative, health-protective method of estimating dietary
intake that is based upon conservative assumptions related to the
amount of residues that can be transferred to foods as a result of the
proposed use. This same methodology has been utilized by FDA in
estimating dietary exposures to antimicrobial pesticides used in food-
handling settings. A complete description of the approach used to
assess dietary exposures resulting from food contact sanitizing
solution uses of n-butyl benzoate can be found at http://www.regulations.gov in document ``n-Butyl Benzoate; Human Health Risk
Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as an Inert
Ingredient in Pesticide Formulations,'' pp. 13-15 in docket ID number
EPA-HQ-OPP-2014-0265.
    The exposures from food and food contact sanitizing are then added
together for the final dietary exposure assessment.
    2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for n-butyl benzoate, a
conservative drinking water concentration value of 100 ppb based on
screening level modeling was used to assess the contribution to
drinking water for the chronic dietary risk assessments for parent
compound. These values were directly entered into the dietary exposure
model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    There are no current or proposed residential uses for n-butyl
benzoate, however it is possible that n-butyl benzoate may be used as
an inert ingredient in pesticide products that may have uses resulting
in potential residential exposures. A complete description of the
approach used to assess possible residential exposures from n-butyl
benzoate can be found at http://www.regulations.gov in document ``n-
Butyl Benzoate; Human Health Risk Assessment and Ecological Effects
Assessment to Support Proposed Exemption from the Requirement of a
Tolerance When Used as an Inert Ingredient in Pesticide Formulations,''
pp. 16 in docket ID number EPA-HQ-OPP-2014-0265.
    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 n-butyl benzoate to share a common mechanism of
toxicity with any other substances, and n-butyl benzoate does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
n-butyl benzoate 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. There is an evidence of
increased susceptibility of infants and children in the OECD 422 study
in rats. In this study, the NOAEL for parental toxicity was 1,000 mg/
kg/day; the highest dose tested while the NOAEL for embryo-fetal
toxicity was 500 mg/kg/day based on increased pup mortality on post-
natal day zero seen at the LOAEL of 1,000 mg/kg/day. However, the
concern for this susceptibility is low because there is clear NOAEL
established in the study protecting the offspring, and regulatory doses
were selected to be protective of these effects. No other residual
uncertainties were identified with respect to susceptibility. The
endpoints and doses selected for the dietary risk assessment of n-butyl
benzoate are protective of adverse effects in both offspring and
adults.
    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 n-butyl benzoate contains acute
toxicity, subchronic toxicity, reproductive toxicity, developmental
toxicity, and genotoxicity data. No immunotoxicity or neurotoxicity
study is available; however, there was no evidence of any triggers for
immunotoxicity or neurotoxicity in the database. Therefore, there is no
need for immunotoxicity or neurotoxicity study at this time and no need
for additional uncertainty factor for the lack of those studies.
    ii. Although there is evidence that n-butyl benzoate results in
increased susceptibility in the combined repeated dose toxicity study
with the reproduction/developmental toxicity screening test in rats,
that study identified a clear NOAEL for offspring effects, which the
Agency is using as the endpoint for its assessment. Therefore, the
concern for these effects is low and there is no need for an additional
uncertainty factor.
    iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues, as well as conservative
assumptions for food-contact surface sanitizers. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to n-butyl benzoate in drinking water. These
assessments will not underestimate the exposure and risks posed by n-
butyl benzoate.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
n-butyl benzoate is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
n-butyl benzoate from food and water will utilize 21.0% of the cPAD for
the U.S. population and 94.1% of the cPAD for children 1-2 years old,
the population group receiving the greatest exposure.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). While n-butyl benzoate
is not currently used as an inert ingredient in pesticide products that
are registered for uses that could result in short- or intermediate-
term residential exposure, it is possible that n-butyl benzoate could
be used in such products and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
potential short- and intermediate-term residential exposures to n-butyl
benzoate.
    Using the exposure assumptions described in this unit for short-and
intermediate-term exposures, EPA has concluded the combined food,
water, and residential exposures result in aggregate short- and
intermediate-term MOEs of 320 for adults and 100 for children (1-2
years old). EPA's level of concern for n-butyl benzoate is a MOE of 100
or below; however these MOEs are not of concern based on the highly
conservative assumptions made regarding residential and dietary
exposures to n-butyl benzoate as described in Unit IV. Section C.
    4. Aggregate cancer risk for U.S. population. Based on data that n-
butyl benzoate is metabolized by esterase mediated hydrolysis resulting
in the formation of two major polar metabolites, n-butyl alcohol and
benzoic acid. Each metabolite enters other degradation pathways to be
rapidly metabolized and/or excreted, n-butyl benzoate is not expected
to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to n-butyl benzoate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method for enforcement purposes is not required for
n-butyl benzoate in pesticide formulations that include uses on crops
for pre- and post-harvest, and on animals, since the Agency is
establishing an exemption from the requirement of a tolerance without
any numerical limitation.
    An analytical method is also not required for enforcement purposes
for n-butyl benzoate on food-contact surfaces in antimicrobial
applications since the Agency is not establishing a numerical tolerance
for residues of n-butyl benzoate in or on any food commodities. EPA is
establishing a

limitation on the amount of n-butyl benzoate that may be used in food-
contact surface antimicrobial applications. That limitation will be
enforced through the pesticide registration process under the Federal
Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136
et seq. EPA will not register any food-contact surface antimicrobial
applications for sale or distribution that contains greater than 15,000
ppm (1.5%) of n-butyl benzoate by weight.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are
established under 40 CFR 180.910, 180.930, and 180.940(a) for n-butyl
benzoate (CAS Reg. No. 136-60-7) when used as an inert ingredient
(solvent) in pesticide formulations applied to growing crops, raw
agricultural commodities after harvest, and animals, and when used as
an inert ingredient in antimicrobial formulations in food-contact
surface sanitizer products at a maximum level in the end-use
concentration of 15,000 parts per million (ppm).

VII. Statutory and Executive Order Reviews

    This action establishes exemptions from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action 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 action 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 FFDCA section 408(d), such as the exemptions 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 action 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 FFDCA section 408(n)(4). 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: May 29, 2015.
Daniel J. Rosenblatt,
Acting Director, Registration Division, 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. In Sec.  180.910, add alphabetically the inert ingredient to the
table to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
           Inert ingredients             Limits            Uses
------------------------------------------------------------------------

                                * * * * *
n-Butyl benzoate (CAS Reg. No.136-60-   ........  Solvent.
 7).

                                * * * * *
------------------------------------------------------------------------

0
3. In Sec.  180.930, add alphabetically the inert ingredient to the
table to read as follows:

Sec.  180.930  Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
           Inert ingredients             Limits            Uses
------------------------------------------------------------------------

                                * * * * *
n-Butyl benzoate (CAS RN 136-60-7)....  ........  Solvent.

                                * * * * *
------------------------------------------------------------------------

0
4. In Sec.  180.940(a) add alphabetically the inert ingredient to the
table to read as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).

* * * * *
    (a) * * *

----------------------------------------------------------------------------------------------------------------
                 Pesticide chemical                      CAS Reg. No.                     Limits
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
n-Butyl benzoate....................................           136-60-7   When ready for use, the end-use
                                                                           concentration is not to exceed 15,000
                                                                           ppm.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-13818 Filed 6-4-15; 8:45 am]
BILLING CODE 6560-50-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY

2000 TRAVERWOOD DRIVE

ANN ARBOR, MI  48105-2498

									     OFFICE OF

									AIR AND RADIATION

11/17/15

MEMORANDUM

SUBJECT: Test Procedure Meeting with the Engine Manufacturers
Association

FROM: Christopher Laroo

TO:  Greenhouse Gas Emissions Standards and Fuel Efficiency Standards
for Medium- and

Heavy-Duty Engines and Vehicles - Phase 2 - Docket EPA-HQ-OAR-2014-0827

This memo documents a meeting held on November 17 and 18, 2015 between
representatives of the Engine Manufacturers Association and EPA to
discuss test procedures recently proposed in the Phase 2 greenhouse gas
and fuel efficiency standards for heavy-duty vehicles notice of proposed
rulemaking.  The meeting attendees, agenda, and draft part 1065 working
document are enclosed.

The discussion topics included test procedures in 40 CFR part 1065 and
fuel maps for engines as proposed in 1036.535 and 1036.540.


[Federal Register Volume 80, Number 42 (Wednesday, March 4, 2015)]
[Notices]
[Pages 11712-11713]
[FR Doc No: 2015-04420]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74380; File No. SR-EDGA-2015-12]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Rule 11.11, Routing to Away Trading Centers, To Delete References to
the ROLF Routing Option, Which Routed Orders to LavaFlow ECN

February 26, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on February 23, 2015, EDGA Exchange, Inc. (the ``Exchange'' or
``EDGA'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend Rule 11.11, Routing to Away
Trading Centers, to delete references to the ROLF routing option, which
routed orders to LavaFlow ECN.
    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Rule 11.11, Routing to Away Trading
Centers, to delete references under subparagraphs (7) and (15) to the
ROLF routing option, which routed to LavaFlow ECN. These changes are
being proposed in response to LavaFlow ECN ceasing market operations on
Friday, January 30, 2015. Under Rule 11.11(g)(7), an order utilizing
the ROLF routing option first checked the System \5\ for available
shares and was then routed to the LavaFlow ECN. If shares remained
unexecuted after being routed, they were cancelled, unless otherwise
instructed by the User.\6\ In addition, under Rule 11.11(g)(15), a User
was able to couple the Post to Away option and ROLF routing option. The
grouping of the Post to Away and ROLF routing options instructed the
System to route and post the order on LavaFlow ECN. As of February 2,
2015, the Exchange, via BATS Trading, the Exchange's affiliated routing
broker-dealer, was no longer able to route orders to LavaFlow ECN
because it ceased operations. As a result, the Exchange no longer
offers the ROLF routing option nor permit [sic] it to be coupled with a
Post to Away routing option. Therefore, the Exchange proposes to delete
the ROLF routing option under Rule 11.11(g)(7) as well as a reference
to the ROLF routing option under Rule 11.11(g)(15).
---------------------------------------------------------------------------

    \5\ Exchange Rule 1.5(cc) defines ``System'' as ``the electronic
communications and trading facility designated by the Board through
which securities orders of Users are consolidated for ranking,
execution and, when applicable, routing away.''
    \6\ The term ``User'' is defined as ``any Member or Sponsored
Participant who is authorized to obtain access to the System
pursuant to Rule 11.3.'' See Exchange Rule 1.5(ee).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \7\ in general, and furthers the objectives of Section
6(b)(5) of the Act \8\ in particular, in that it is designed to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system and, in general, to
protect investors and the public interest. The Exchange does not
believe that this proposal will permit unfair discrimination among
customers, brokers, or dealers because the ROLF routing option will no
longer be available to all Users. The proposed change is in response to
LavaFlow ECN ceasing market operations on Friday, January 30, 2015. As
of February 2, 2015, the Exchange, via BATS Trading, was no longer able
to route orders to LavaFlow ECN and, therefore, proposes to delete
references to the ROLF routing option under Rules 11.11(g)(7) and (15).
The proposal is intended to make the Exchange's rules clearer and less
confusing for investors by eliminating a routing option that is no
longer available; thereby removing impediments to and perfecting the
mechanism of a free and open market and a national market system, and,
in general, protecting investors and the public interest.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposal will impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act. The proposed rule change is not designed to
address any competitive issues but rather avoid investor confusion by
eliminating a routing option that is no longer made available by the
Exchange.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (1)
Significantly affect the protection of investors or the public
interest; (2) impose any significant burden on competition; and (3) by
its terms does not become operative for 30 days after the date of this
filing, or such shorter time as the Commission may designate if
consistent with the protection of investors and the public interest,
the proposed rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \9\ and Rule 19b-4(f)(6) thereunder.\10\
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to provide the Commission
with written notice of its intent to file the proposed rule change,
along with a brief description and text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has met this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing. However,
Rule 19b-4(f)(6)(iii) permits the Commission to designate a shorter
time if such action is consistent with the protection of investors and
the public interest. The Exchange has asked the Commission to waive the
30-day operative delay so that the proposal may become operative
immediately upon filing. The Commission believes that waiving the 30-
day operative delay is consistent with the protection of investors and
the public interest as it will allow the Exchange to avoid potential
investor confusion during the operative delay period by immediately
eliminating exchange rules that account for a routing option that the
Exchange can no longer provide due to LavaFlow ECN's cessation of
operations.\11\ Accordingly, the Commission hereby grants the
Exchange's request and designates the proposal operative upon filing.
---------------------------------------------------------------------------

    \11\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-EDGA-2015-12 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-EDGA-2015-12. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-EDGA-2015-12, and should be
submitted on or before March 25, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-04420 Filed 3-3-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: February 19, 2009 (Volume 74, Number 32)]
[Notices]
[Page 7696-7697]
[DOCID:fr19fe09-58]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Circulatory System Devices Panel of the Medical
Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 18, 2009, from 8
a.m. to 5:30 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: James Swink, Center for Devices and Radiological
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850,<PHONE_NUMBER>, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area), code<PHONE_NUMBER>. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn

about possible modifications before coming to the meeting.
    Agenda: The committee will discuss, make recommendations, and vote
on a premarket approval application, sponsored by TherOx, Inc., for the
TherOx Aqueous Oxygen System (AO System). The system is intended for
use in acute myocardial infarction (AMI) patients, who have undergone
successful revascularization less than or equal to 6 hours from symptom
onset. These patients were randomized to AO Therapy or not. The
endpoint is reduction in the final size of the infarct. The system
draws blood from the patient, hyperoxygenates it with the AO cartridge
component of the system, and reinfuses the blood via the infusion
catheter directly to the infarction site of the heart. This therapy is
intended to be performed for 90 minutes post percutaneous coronary
intervention/stenting.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2009 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
March 4, 2009. Oral presentations from the public will be scheduled
approximately 30 minutes at the beginning of committee deliberations
and approximately 30 minutes near the end of the deliberations. Those
desiring to make formal oral presentations should notify the contact
person and submit a brief statement of the general nature of the
evidence or arguments they wish to present, the names and addresses of
proposed participants, and an indication of the approximate time
requested to make their presentation on or before February 25, 2009.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by February 26, 2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Conference Management Staff, at<PHONE_NUMBER>, at least 7 days in
advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 10, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-3488 Filed 2-18-09; 8:45 am]

BILLING CODE 4160-01-S