[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)]
[Proposed Rules]
[Pages 50233-50235]
[FR Doc No: 2015-20267]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-3142; Directorate Identifier 2015-NM-003-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 787-8 airplanes. This proposed AD was
prompted by reports of hydraulic contamination of the power control
unit (PCU) electro-hydraulic servo valves (EHSVs) used in the flight
control system; this contamination caused a restriction in the EHSVs
resulting in the display of status messages from the engine indication
and crew alerting system (EICAS). This proposed AD would require
installing markers to limit the hydraulic system fluid used to a
specific brand, doing hydraulic fluid tests of the hydraulic systems,
replacing hydraulic system fluid if necessary, and doing all applicable
related investigative and corrective actions. We are proposing this AD
to prevent the failure of flight control hydraulic PCUs, which could
lead to reduced controllability of the airplane.

DATES: We must receive comments on this proposed AD by October 5, 2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management, P.
O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone<PHONE_NUMBER>,
extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
You may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>. It
is also available on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2015-3142.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
3142; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Fnu Winarto, Aerospace Engineer,
Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft
Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-
3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2015-3142;
Directorate Identifier 2015-NM-003-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We received reports of the display of status messages from the
engine indication and crew alerting system (EICAS). Boeing and the
actuation system supplier determined these messages are displayed when
electro-hydraulic servo valves (EHSVs) of the power control units
(PCUs) of the primary flight control system are restricted due to the
accumulation of particle deposits. Failures have only occurred on
airplanes operated with Skydrol LD-4 hydraulic fluid. Changing the
hydraulic fluid to HyJet V would reduce the rate of particle deposit
accumulation. This condition, if not corrected, could result in the
eventual failure of flight control hydraulic PCUs, which could lead to
reduced controllability of the airplane.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin B787-81205-SB270026-00,
Issue 001, dated November 25, 2014. This service information describes
procedures for installing markers to limit the hydraulic system fluid
used to a specific brand, doing hydraulic fluid tests of the hydraulic
systems, replacing the hydraulic system fluid if necessary, and related
investigative and corrective actions. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section of this NPRM.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously. Refer to this service
information for details on the procedures and compliance times.
    The phrase ``related investigative actions'' is used in this
proposed AD. ``Related investigative actions'' are follow-on actions
that (1) are related to the primary actions, and (2) further
investigate the nature of any condition found. Related investigative
actions in an AD could include, for example, inspections.
    The phrase ``corrective actions'' is used in this proposed AD.
``Corrective actions'' are actions that correct or address any
condition found. Corrective

actions in an AD could include, for example, repairs.

Explanation of ``RC'' Steps in Service Information

    The FAA worked in conjunction with industry, under the
Airworthiness Directive Implementation Aviation Rulemaking Committee
(ARC), to enhance the AD system. One enhancement was a new process for
annotating which steps in the service information are required for
compliance with an AD. Differentiating these steps from other tasks in
the service information is expected to improve an owner's/operator's
understanding of crucial AD requirements and help provide consistent
judgment in AD compliance. The steps identified as RC (required for
compliance) in any service information identified previously have a
direct effect on detecting, preventing, resolving, or eliminating an
identified unsafe condition.
    For service information that contains steps that are labeled as
Required for Compliance (RC), the following provisions apply: (1) The
steps labeled as RC, including substeps under an RC step and any
figures identified in an RC step, must be done to comply with the AD,
and an AMOC is required for any deviations to RC steps, including
substeps and identified figures; and (2) steps not labeled as RC may be
deviated from using accepted methods in accordance with the operator's
maintenance or inspection program without obtaining approval of an
AMOC, provided the RC steps, including substeps and identified figures,
can still be done as specified, and the airplane can be put back in an
airworthy condition.

Costs of Compliance

    We estimate that this proposed AD affects 11 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Installing markers....................  2 work-hours x $85 per               $95            $265          $2,915
                                         hour = $170.
Test and replace left, center, and      104 work-hours x $85 per           1,020           9,860         108,460
 right hydraulic system fluid.           hour = $8,840.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the proposed inspection.
We have no way of determining the number of aircraft that might need
these replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace power control unit of elevator........  9 x $85 per hour = $765.........        $108,000        $108,765
Replace power control unit of aileron.........  9 x $85 per hour = $765.........         118,000         118,765
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    (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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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 airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2015-3142; Directorate Identifier
2015-NM-003-AD.

(a) Comments Due Date

    We must receive comments by October 5, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 787-8 series
airplanes, certificated in any category, as identified in Boeing
Alert Service Bulletin B787-81205-SB270026-00, Issue 001, dated
November 25, 2014.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
Control Systems.

(e) Unsafe Condition

    This proposed AD was prompted by reports of hydraulic
contamination of the power control unit (PCU) electro-hydraulic
servo valves (EHSVs) used in the flight control system. This
contamination caused a restriction in the EHSVs resulting in the
display of status messages from the engine indication and crew
alerting system (EICAS). We are issuing this AD to prevent failure
of flight control hydraulic PCUs, which could lead to reduced
controllability of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Marker Installation

    Within 36 months after the effective date of this AD, install
markers to only allow servicing of hydraulic systems with HyJet V
hydraulic fluid, in accordance with the Accomplishment Instructions
of Boeing Alert Service Bulletin B787-81205-SB270026-00, Issue 001,
dated November 25, 2014.

(h) Fluid Tests of the Left, Right, and Center Hydraulic Systems

    For airplanes identified by Boeing Alert Service Bulletin B787-
81205-SB270026-00, Issue 001, dated November 25, 2014, as Group 1,
Configuration 2, Group 2: Within 36 months after the effective date
of this AD, do hydraulic fluid tests of the left, right, and center
hydraulic systems, replace the hydraulic system fluid, if necessary,
and do all applicable related investigative and corrective actions,
in accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin B787-81205-SB270026-00, Issue 001, dated November
25, 2014. Do all applicable related investigative and corrective
actions within 36 months after the effective date of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
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 manager of the ACO, send it to the
attention of the person identified in paragraph (j)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) 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.
    (3) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of paragraphs
(i)(3)(i) and (i)(3)(ii) apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. An AMOC is required for any deviations to RC steps,
including substeps and identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.
    (4) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

(j) Related Information

    (1) For more information about this AD, contact Fnu Winarto,
Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA,
Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW.,
Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on August 10, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-20267 Filed 8-18-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Notices]
[Pages 60254-60255]
[FR Doc No: 2017-27232]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82313; File No. SR-ICEEU-2017-013]

Self-Regulatory Organizations; ICE Clear Europe Limited; Order
Approving Proposed Rule Change Relating to the ICE Clear Europe
Procyclicality Framework

December 13, 2017.

I. Introduction

    On October 23, 2017, ICE Clear Europe Limited (``ICE Clear
Europe'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change (SR-ICEEU-2017-013) to adopt a new policy
framework for addressing the procyclicality (``Procyclicality
Framework'') associated with its risk management policies.
Specifically, the Procyclicality Framework would establish the risk
appetite, monitoring and assessment, and management of procyclicality
in the risk models used by ICE Clear Europe to manage default risk. The
proposed rule change was published for comment in the Federal Register
on November 7, 2017.\3\ The Commission did not receive comments on the
proposed rule change. For the reasons discussed below, the Commission
is approving the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 34-81994 (Nov. 1, 2017),
82 FR 51663 (Nov. 7, 2017) (SR-ICEEU-2017-013) (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    ICE Clear Europe proposed to adopt a Procyclicality Framework that
is intended to set forth, generally, (1) the aspects of ICE Clear
Europe's risk policies that may exhibit procyclicality; (2) the manner
in which ICE Clear Europe will assess procyclicality (using both
qualitative and a quantitative metrics); and (3) how ICE Clear Europe
will take procyclicality into account with respect to its consideration
of and response to emerging risks. ICE Clear Europe proposed to define
``procyclicality'' as the extent to which changes in market conditions
can have an effect on a clearing member's ability to manage its
liquidity to meet ICE Clear Europe's changing margin requirements.\4\
---------------------------------------------------------------------------

    \4\ Notice, 82 FR at 51663.
---------------------------------------------------------------------------

    ICE Clear Europe represented that although it has in place certain
measures intended to mitigate procyclicality, as required by the
European Market Infrastructure Regulation,\5\ it proposed to implement
the Procyclicality Framework in order to establish a more defined
approach to assessing procyclicality in its risk management policies
and procedures.\6\ In particular, ICE Clear Europe proposed to identify
the risk management policies that may introduce procyclical concerns,
which includes margin models, stress testing, and collateral haircut
policies. In addition, as part of the Procyclicality Framework, ICE
Clear Europe also proposed to reference existing methods for mitigating
procyclicality in the above mentioned areas, as well as certain stress
testing arrangements.\7\
---------------------------------------------------------------------------

    \5\ Article 28 of the Commission Delegated Regulation (EU) No
153/2013 of 19 December 2012 supplementing Regulation (EU) No 648/
2012 of the European Parliament and of the Council with regard to
regulatory technical standards on requirements for central
counterparties.
    \6\ Notice, 82 FR at 51663.
    \7\ Id.
---------------------------------------------------------------------------

    Furthermore, ICE Clear Europe proposed to incorporate into the
Procyclicality Framework the measures by which it would assess the
level of procyclicality. Specifically, ICE Clear Europe proposed to
assess procyclicality by monitoring the 95th percentile expected
shortfall of the 5-day

percentage change in initial margin (or other relevant risk mitigant)
over a rolling 250-day window. ICE Clear Europe represented that this
metric would be used to measure short term spikes in margin.\8\ In
addition, ICE Clear Europe would also take into consideration the
largest percentage changes, and use these observations, as well as the
estimates of the expected shortfall, to detect and remove extreme
outliers from the data.
---------------------------------------------------------------------------

    \8\ Id.
---------------------------------------------------------------------------

    In the event procyclicality is identified using this measure, ICE
Clear Europe proposed an escalation process that provides for review
and response obligations.\9\ The nature of the response would vary
based on predetermined thresholds for the expected 95th percentile
expected shortfall metric described above.\10\
---------------------------------------------------------------------------

    \9\ Id.
    \10\ Id.
---------------------------------------------------------------------------

    To further assess procyclicality, ICE Clear Europe also proposed to
incorporate several qualitative factors into the Procyclicality
Framework. These proposed qualitative factors include the periodicity
of margin updates, the activities of other central counterparties in
relevant markets, the expectations of market participants and related
potential for moral hazard stemming from an expectation of gradual
margin changes, and the ability of ICE Clear Europe to override, in
extreme circumstances, standard measures designed to mitigate
procyclicality.\11\ Moreover, ICEEU proposed to take into account
differences across markets when implementing measures intended to
mitigate procyclicality, as well as the varying liquidity resources and
practices of the different types of Clearing Members that use the
services of ICE Clear Europe.\12\
---------------------------------------------------------------------------

    \11\ Notice, at 82 FR at 51664.
    \12\ Id.
---------------------------------------------------------------------------

    With respect to future risk model design, ICE Clear Europe proposed
to incorporate into the Procyclicality Framework a requirement that its
model design process take into account any procyclicality
characteristics that a model may exhibit, and that the model design
process also take into account the impact of any steps designed to
mitigate procyclicality.\13\
---------------------------------------------------------------------------

    \13\ Notice, 82 FR at 51663-64.
---------------------------------------------------------------------------

    Finally, ICE Clear Europe proposed to include in the Procyclicality
Framework consideration of the procyclicality of new products and
procyclicality arising from material changes in existing products. ICE
Clear Europe has represented that much of its Procyclicality Framework
will be available on its website.\14\
---------------------------------------------------------------------------

    \14\ Id.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act directs the Commission to approve a
propose rule change of a self-regulatory organization if it finds that
such proposed rule change is consistent with the requirements of the
Act and the rules and regulations thereunder applicable to such
organization.\15\ Further, Section 17A(b)(3)(F) of the Act requires,
among other things, that the rules of a registered clearing agency be
designed to promote the prompt and accurate clearance and settlement of
securities transactions and, to the extent applicable, derivative
agreements, contracts, and transactions, to assure the safeguarding of
securities and funds which are in the custody or control of the
clearing agency or for which it is responsible, and, in general, to
protect investors and the public interest.\16\ Rule 17Ad-22(e)(2)
requires, in relevant part, that a covered clearing agency establish,
implement, maintain, and enforce written policies and procedures
reasonably designed to provide for governance arrangements that are
clear and transparent, that clearly prioritize the safety and
efficiency of the covered clearing agency, and that support the public
interest requirements of Section 17A of the Act, applicable to clearing
agencies, and the objectives of owners and participants.\17\
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(2)(C).
    \16\ 15 U.S.C. 78q-1(b)(3)(F).
    \17\ 17 CFR 240.17Ad-22(e)(2).
---------------------------------------------------------------------------

    The Commission finds that the proposed rule change, which would
implement a new Procyclicality Framework, is consistent with the
requirements of Section 17A of the Act and the relevant provisions of
Rule 17Ad-22 thereunder. By establishing a Procyclicality Framework
that (1) identifies risk management policies and procedures exhibiting
procyclicality, (2) establishes a measure for assessing procyclicality
in such risk management policies and procedures, and (3) provides for a
process requiring review and defined responses in the event that
certain procyclicality thresholds are exceeded, the Commission believes
that ICE Clear Europe will have an increased ability to identify,
assess and respond to procyclicality that arises in connection with the
clearing services it provides. Consequently, the Commission believes
that the Procyclicality Framework will enhance ICE Clear Europe's
ability to mitigate the risks associated with procyclicality, thereby
facilitating ICE Clear Europe's collection of the appropriate level of
resources to manage its risks in a variety of market conditions,
including stressed market conditions. This expected outcome, in turn,
will permit ICE Clear Europe to provide prompt and accurate clearance
and settlement of the products for which it offers clearing services,
and more adequately protect its Clearing Members in the event of a
default, which will enhance ICE Clear Europe's ability to safeguard the
securities and funds which are in its custody or control. For these
reasons, the Commission also believes that implementing the
Procyclicality Framework is in the public interest. Therefore, the
Commission finds that the proposed rule change implementing a new
Procyclicality Framework is consistent with the requirements of Section
17A.
    Additionally, by implementing the Procyclicality Framework, which
includes a process for review and response to assessments of
procyclicality based on quantitative and qualitative metrics and the
relation of those metrics to predefined thresholds, and by publishing
portions of the Procyclicality Framework on its website, the Commission
believes that ICE Clear Europe is establishing policies and procedures
that are consistent with the requirements of Rule 17Ad-22(e)(2).

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\18\ that the proposed rule change (ICEEU-2017-013) be, and hereby,
is approved.\19\
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(2).
    \19\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).
    \20\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-27232 Filed 12-18-17; 8:45 am]
 BILLING CODE 8011-01-P


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2005-MD-0013]; FRL-       ]

Approval and Promulgation of Air Quality Implementation Plans; Maryland;
Amendments to the Control of Incinerators

AGENCY:  Environmental Protection Agency (EPA).

ACTION:   Final rule.

SUMMARY:  EPA is approving a State Implementation Plan (SIP) revision
submitted by the Maryland Department of the Environment (MDE).  This
revision pertains to amendments to the regulations for the control of
incinerators.  This action is being taken under the Clean Air Act (CAA
or the Act).

EFFECTIVE DATE:  This final rule is effective on [insert date 30 days
from date of publication].

ADDRESSES:  EPA has established a docket for this action under Docket
ID Number EPA-R03-OAR-2005-MD-0013.  All documents in the docket are
listed in the www.regulations.gov website.   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 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 Maryland Department of the Environment,
1800 Washington Boulevard, Suite 705, Baltimore, Maryland 21230.

FOR FURTHER INFORMATION CONTACT:  Marilyn Powers,<PHONE_NUMBER>, or by
e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:

I.  Background

On January 31, 2006 (70 FR 5033), EPA published a notice of proposed
rulemaking (NPR) for the State of Maryland.  The NPR proposed approval
of the amendments to regulations .01 and .05 under COMAR 26.11.08
Control of Incinerators.  The formal SIP revision was submitted by the
MDE on October 31, 2005 (#05-06).  Other specific requirements of the
SIP revision and the rationale for EPA's proposed action are explained
in the NPR and will not be restated here.  On March 2, 2006, EPA
received an adverse comment on its January 31, 2006 NPR.  A summary of
the comment submitted and EPA(s response is provided in Section II of
this document.

II.  Summary of Public Comments and EPA Responses

Comment:  A commenter submitted test results from the following
pollutants: visible emissions, particulate matter, carbon monoxide,
nitrogen oxides, sulfur dioxide, hydrogen chloride, metals (cadmium,
mercury, and lead), dioxins, and furans concerning human and animal
crematories.  The test results show that the emissions of nearly all the
tested pollutants increased when the operating temperature was raised.
From the test results, the commenter indicates that there is no benefit
to the higher operating temperatures required in many states.  The
commenter indicates that the test results also demonstrate that
crematories are capable of low emissions without the use of additional
control equipment.

Response:  This rulemaking is limited to the amendments of .01 and .05
under COMAR 26.11.08 Control of Incinerators.  These amendments define
the term (crematory( and clarify that crematories are subject to the 0.1
grain loading particulate matter requirement. This rulemaking does not
address visible emissions or emissions of carbon monoxide, nitrogen
oxides, sulfur dioxide, hydrogen chloride, metals, dioxins, and furans.
Comments regarding emissions of these pollutants are not relevant to
this rulemaking.  EPA is required to respond only to comments relevant
to the rulemaking.  See, e.g., Whitman v. American Trucking Ass(n., 531
U.S. 457, 471 (2001).  To the extent that the comment addresses a
pollutant relevant to this rulemaking, such as particulate matter, the
commenter appears to be challenging the State(s decision to regulate
crematories in the particular manner it has chosen.  The CAA is based
upon "cooperative federalism,” which contemplates that each State will
develop its own SIP, and that States retain a large degree of
flexibility in choosing which sources to control and to what degree.
EPA must approve a State's plan if it meets the minimum requirements of
the CAA.  Union Electric Co. v. EPA, 427 U.S. 246, 264-266 (1976).  The
comment therefore presents no basis for EPA disapproving the proposed
SIP revision.

III. Final Action

EPA is approving Maryland(s SIP revision submitted on October 31, 2005.
 The SIP revision clarifies that crematories are subject to the
particulate matter requirements of COMAR 26.11.08 by amending the
definitions in section .01 and the emissions requirements in section
.05.

IV.   Statutory and Executive Order Reviews

A.   General Requirements

Under the Clean Air Act, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations.  42 U.S.C. 7410(k); 40 CFR 52.02(a).  Thus, in
reviewing SIP submissions, EPA’s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law.  For that reason, this action:

is not a "significant regulatory action” subject to review by the
Office of Management and Budget under Executive Order 12866 (58 FR
51735, October 4, 1993);

does not impose an information collection burden under the provisions of
the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

is certified as not having a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.);

does not contain any unfunded mandate or significantly or uniquely
affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Public Law 104-4);

does not have Federalism implications as specified in Executive Order
13132 (64 FR 43255, August 10, 1999);

is not an economically significant regulatory action based on health or
safety risks subject to Executive Order 13045 (62 FR 19885, April 23,
1997);

is not a significant regulatory action subject to Executive Order 13211
(66 FR 28355, May 22, 2001);

is not subject to requirements of Section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those requirements would be inconsistent with the
Clean Air Act; and

does not provide EPA with the discretionary authority to address, as
appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive Order
12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP
is not approved to apply in Indian country located in the state, and EPA
notes that it will not impose substantial direct costs on tribal
governments or preempt tribal law.

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 Clean Air Act, petitions for judicial
review of this action must be filed in the United States Court of
Appeals for the appropriate circuit by [Insert date 60 days from date of
publication of this document in the Federal Register].  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 action approving a Maryland SIP revision that
amends COMAR 26.11.08 may not be challenged later in proceedings to
enforce its requirements.  (See section 307(b)(2).)

List of Subjects in 40 CFR part 52

Environmental protection, Air pollution control, Incorporation by
reference, Particulate matter.

   August 29, 2008						/s/

______________________
___________________________

Dated:                            				Donald S. Welsh,
              								Regional Administrator,

                                  					Region III.

40 CFR part 52 is amended as follows:

PART 52 - [AMENDED]

1.  The authority citation for part 52 continues to read as follows:

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

Subpart V( Maryland

2. In ( 52.1070, the table in paragraph (c) is amended by revising the
entries for COMAR <IP_ADDRESS> and <IP_ADDRESS> to read as follows:

( 52.1070  		Identification of plan.

*		*		*		*		*

(c)* * *

EPA-APPROVED REGULATIONS IN THE MARYLAND SIP

Code of Maryland administrative regulations (COMAR) citation

Title/subject

State effective date

EPA approval date

Additional explanation/

citation at 40 CFR ( 52.1100

          *            *               *              *              *
              *             *

COMAR 10.18.08/26.11.08

Control of Incinerators

10.18.08/<IP_ADDRESS>

Definitions

9/12/05

[Insert Federal Register publication date]

[Insert page number where the document begins]

Definition of “crematory” is added.

 *             *               *                *                *
        *           *

10.18.08/<IP_ADDRESS>

Particulate Matter

9/12/05

[Insert Federal Register publication date]

[Insert page number where the document begins]

Sections .05A(3) and .05B(2)(a) are revised.

*             *               *                *                *
       *           *

*  	*	*	*	*

 PAGE  7


[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Rules and Regulations]
[Pages 45443-45448]
[FR Doc No: 2015-18741]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0714; FRL-9927-63]

Benalaxyl-M; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
benalaxyl-M in or on grape and tomato. Since there are currently no
U.S. registrations of benalaxyl-M for use on grape and tomato, this
tolerance will allow the import of grape and tomato containing residues
of benalaxyl-M. Technology Sciences Group, on behalf of Isagro S.p.A,
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective July 30, 2015. Objections and
requests for hearings must be received on or before September 28, 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-2013-0714, 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 EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing 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-2013-0714 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
September 28, 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-2013-0714, 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. Summary of Petitioned-for Tolerance

    In the Federal Register of February 21, 2014 (79 FR 9870) (FRL-
9904-98), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
3E8162) by Technology Sciences Group on behalf of Isagro S.p.A., 1150
18th Street NW., Suite 1000, Washington, DC 20036. The petition
requested that 40 CFR part 180 be amended by establishing import
tolerances for residues of the fungicide benalaxyl-M in or on grape at
1.1 parts per million (ppm); grape juice at 1.1 ppm; grape wine at 1.1
ppm; grape raisin at 2.2 ppm; tomato at 0.25 ppm; and tomato processed
at 0.25 ppm. That document referenced a summary of the petition
prepared by Technology Sciences Group on behalf of Isagro S.p.A., the
registrant, which is available in the docket, http://www.regulations.gov. No tolerance-related comments were submitted.
    Based upon review of the data supporting the petition, EPA is
establishing tolerances as follows: 3.0 ppm for grapes and 0.20 ppm for
tomato. The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 benalaxyl-M including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with benalaxyl-M 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.
    Benalaxyl-M has no significant acute toxicity via oral, dermal or
inhalation route of exposure. It is not a skin irritant and does not
cause skin sensitization.
    The liver and thyroid are the primary target organs for benalaxyl-
M. In rats, increased liver weights, clinical chemistry changes
indicative of liver toxicity, hepatocellular hypertrophy, and thyroid
follicular cell hypertrophy were seen following subchronic and chronic
exposure. In mice, increased liver weight and microscopic lesions in
the liver (hepatocellular hypertrophy, necrosis, eosinophilic foci)
were observed following subchronic and chronic exposure. Additionally,
chronic exposure in rats and mice led to increases in the incidence of
liver (rat, mouse) and thyroid (rat) tumors. In dogs, increased liver
weight, changes in clinical chemistry indicative of liver toxicity, and
hepatocellular hypertrophy were observed following subchronic exposure
via the diet, whereas clinical chemistry changes indicative of liver
toxicity, fat vacuolation in the liver, and thyroid follicular cell
hypertrophy were observed following chronic exposure via capsules.
    No evidence of increased quantitative or qualitative susceptibility
was seen in the benalaxyl-M hazard database following in utero exposure
with rats or rabbits in the prenatal developmental studies or in young
rats in the 2-generation reproduction study. No evidence of maternal
toxicity or developmental effects was observed in the developmental
toxicity studies in rabbits or rats. There is no reproductive concern.
No neurotoxic effects were observed in the acute and subchronic
neurotoxicity studies in rats, and no immunotoxic effects were observed
in the immunotoxicity study in rats.
    Benalaxyl-M was classified as ``Likely to be Carcinogenic to
Humans''. This determination was based on the treatment-related liver
tumors observed in male mice, liver tumors observed in male and female
rats; and thyroid follicular cell tumors observed in female rats. No
treatment-related tumors were observed in female mice. A linear low-
dose extrapolation model (Q*1) was used to estimate cancer
risk, based on the male mouse liver tumor rates. There is no
mutagenicity concern from the in vivo or in vitro genetic toxicity
assays.
    Specific information on the studies received and the nature of the
adverse effects caused by benalaxyl-M as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Benalaxyl-M. Human-Health Risk
Assessment for Tolerances in/on Imported Grape and Tomato'' on pages 10
through 20 in docket ID number EPA-HQ-OPP-2013-0714.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for benalaxyl-M used for
human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Benalaxyl-M for
Use in Human Health Risk Assessment

 Table 4.5.4.--Summary of Toxicological Doses and Endpoints for Benalaxyl-M for Use in Dietary Human Health Risk
                                                   Assessments
----------------------------------------------------------------------------------------------------------------
                                                  Uncertainty/   RfD, PAD, Level
      Exposure/Scenario            Point of       FQPA safety     of concern for      Study and toxicological
                                  departure         factors      risk assessment              effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General         No appropriate
 Population, including          acute endpoint
 Infants, Children, and         was identified.
 females 13+).
Chronic Dietary..............  NOAEL= 20 mg/kg/ UFA= 10x.......  Chronic RfD =..  Chronic Toxicity/
(All Popyulations)...........   day.            UFH= 10x.......  cPAD = 0.02 mg/   Carcinogenicity Study--rat
                                                FQPA UFDB = 10x   kg/day.          (49040634)
                                                                                LOAEL = 135 mg/kg/day based on
                                                                                based on an increase in
                                                                                [gamma]-glutamyl transferase
                                                                                (GGT) in males, slight
                                                                                increases liver weight in
                                                                                both sexes, increased
                                                                                incidence of hepatocellular
                                                                                hypertrophy in both sexes,
                                                                                increased incidence of
                                                                                thyroid follicular cell
                                                                                hypertrophy in both sexes,
                                                                                increased incidence of
                                                                                thyroid cell hyperplasia in
                                                                                females, increased incidence
                                                                                of thyroid follicular ectasia
                                                                                in females, and an increased
                                                                                incidence of ovarian stromal
                                                                                cell hyperplasia in females.

Cancer (oral)................  Classification:
                                ``Likely to be
                                Carcinogenic
                                to Humans''.
                                Based on male
                                mouse liver
                                tumors, Q1*=
                                5.90 x 10\-3\
                                (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). UFDB = to account for the
  absence of a comparative thyroid study. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (c =
  chronic). RfD = reference dose.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to benalaxyl-M, EPA assessed dietary exposures from benalaxyl-
M in food as follows:
    i. Acute exposure. No such effects were identified in the
toxicological studies for benalaxyl-M; therefore, a quantitative acute
dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
CSFII. As to residue levels in food, EPA used tolerance-level residues
and 100% crop treated.
    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 nonlinear 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 benalaxyl-M should be classified as ``Likely to be
Carcinogenic to Humans'' and a linear approach has been used to
quantify cancer risk. Cancer risk was quantified using the same
estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for benalaxyl-M. Tolerance level residues and/or
100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. An assessment of residues
in drinking water is not required for this assessment because there is
no drinking water exposure in the U.S. associated with the
establishment of an import tolerance.
    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). Benalaxyl-M 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 benalaxyl-M to share a common mechanism of
toxicity with any other substances, and benalaxyl-M does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
benalaxyl-M 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. No evidence of increased
quantitative or qualitative susceptibility was seen following in utero
exposure to benalaxyl-M with rats or rabbits in the prenatal
developmental toxicity studies or in young rats in the 2-generation
reproduction study. The 2-generation reproduction study resulted in no
effects on reproductive function or fertility. The offspring effects
occurred at the same dose that caused parental effects. No evidence of
developmental delay or developmental toxicity was observed in
developmental toxicity studies in rabbits or in rats.
    The rabbit was tested at the limit dose (1000 mg/kg/day), and no
maternal or developmental toxicity was observed. No significant
developmental or maternal toxicity occurred at the highest dose level
tested in the rat study, but the

limit dose was not tested. It is not necessary to require the
submission of an additional rat study since a study at higher dose
levels would not result in a lower NOAEL and the point of departure is
already 10-fold lower than the NOAEL in the rat 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 retained at 10x. That decision is based on the following
findings:
    i. The toxicity database for benalaxyl-M is complete for purposes
of assessing the exposures from the use of benalaxyl-M on imported
grapes and tomatoes. However, there remains some uncertainty regarding
the potential for benalaxyl-M effects on thyroid. Thyroid toxicity was
seen following subchronic and chronic exposures to adult rats. There
are, however, no data regarding the potential effects of benalaxyl-M on
thyroid homeostasis in the young animals. This lack of characterization
creates uncertainty with regards to potential life stage sensitivities
due to exposure to benalaxyl-M. For future uses with higher exposure
potential, the Agency will require a comparative thyroid assay in rats
to assess the potential impact of benalaxyl-M exposure on thyroid
function in the young given the pivotal role of thyroid hormones in
brain development.
    ii. There is no indication that benalaxyl-M 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 benalaxyl-M results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases.

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. 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,
benalaxyl-M 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
benalaxyl-M from food will utilize 1.4% of the cPAD for the general
U.S. population and all population sub-groups. The most highly exposed
population subgroup was children 1-2 years old with an estimated risk
of 7.1% cPAD.
    3. Aggregate cancer risk for U.S. population. The cancer dietary
assessment made use of the same input assumptions as the chronic
analysis. Benalaxyl-M has been classified as ``Likely to be
Carcinogenic to Humans''. A linear low-dose extrapolation model
(Q1*) was used to estimate cancer risk, with a
Q1* = 5.90 x 10-3 (mg/kg/day) -1. The
cancer risk estimate to the U.S. population is 1.7 x 10-6.
EPA generally considers cancer risks in the range of 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 in this unit,
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.
    4. Determination of safety. There are no existing or proposed US
registrations of benalaxyl-M and the only route of exposure is via
dietary ingestion from imported grape and tomato commodities.
Therefore, aggregate exposure and risk estimates are equivalent to the
dietary exposures and risk estimates. 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 benalaxyl-M residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (RA.09.01, a high-performance
liquid chromatography method with tandem mass spectrometry detection
(HPLC/MS/MS) is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; 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 United Nations
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.
    The Codex has established MRLs for benalaxyl-M at 0.3 and 0.2 ppm
in or on grape and tomato, respectively. As a result, the EPA
recommendations will result in harmonization of the U.S. tolerance with
the Codex MRL for tomato, but not for grape since benalaxyl-M residues
from the grape trials in Argentina were significantly higher than the
Codex MRL.

C. Revisions to Petitioned-for Tolerances

    The requested tolerance levels differ from those being established
by EPA. The petitioner used the NAFTA calculator to propose tolerance
levels while EPA used OECD MRL calculation procedures. Additionally,
for determination of the grape and tomato tolerance levels, the
petitioner included the results from all trials. In contrast, EPA
included only those data that matched the critical Good Agricultural
Practice (cGAP). The tolerance for grape, raisin was not recommended
because it is covered by the grape tolerance. No separate tolerances
are needed for grape juice, grape wine, or processed tomato products as
processing studies showed that residues of benalaxyl-M do not
concentrate in these processed commodities.

V. Conclusion

    Therefore, tolerances are established for residues of benalaxyl-M,
in or on grape and tomato at 3.0 and 0.20 ppm, respectively.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances 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 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 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).

VII. 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: July 24, 2015.
Marty Monell,
Acting 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. Add Sec.  180.684 to subpart C to read as follows:

Sec.  180.684  Benalaxyl-M; tolerances for residues.

    (a) General. Tolerances are established for residues of the
fungicide benalaxyl-M, including its metabolites and degradates, in or
on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only benalaxyl
[methyl N-(2,6-dimethylphenyl)-N-(phenylacetyl)-DL-alaninate] in or on
the commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Grape \1\...............................................            3.0
Tomato \1\..............................................            0.20
------------------------------------------------------------------------
\1\ There is no U.S. registration for use on this commodity as of July
  30, 2015.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2015-18741 Filed 7-29-15; 8:45 am]
 BILLING CODE 6560-50-P