[Federal Register Volume 79, Number 173 (Monday, September 8, 2014)]
[Rules and Regulations]
[Pages 53129-53133]
[FR Doc No: 2014-21245]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2013-1002; Special Conditions No. 25-530-SC]

Special Conditions: Airbus Model A350-900 Airplane; Lightning
Protection of Fuel-Tank Structure To Prevent Fuel-Tank Vapor Ignition

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions.

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SUMMARY: These special conditions are issued for Airbus Model A350-900
airplanes.
    These airplanes will have a novel or unusual design feature that
will incorporate a nitrogen generation system (NGS) for all fuel tanks,
to actively reduce flammability exposure within the fuel tanks
significantly below that required by the fuel-tank flammability
regulations. Among other benefits, the NGS significantly reduces the
potential for fuel-vapor ignition caused by lightning strikes. The
applicable airworthiness regulations do not contain adequate or
appropriate safety standards for this design feature. These special
conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that established by the existing airworthiness standards.

DATES:  Effective Date: October 8, 2014.

FOR FURTHER INFORMATION CONTACT: Doug Bryant, Propulsion/Mechanical
Systems, ANM-112, Transport Airplane Directorate, Aircraft
Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On August 25, 2008, Airbus applied for a type certificate for their
new Model A350-900 airplane. Later, Airbus requested, and the FAA
approved, an extension to the application for FAA type certification to
November 15, 2009. The Model A350-900 airplane has a conventional
layout with twin wing-mounted Rolls-Royce Trent XWB engines. It
features a twin-aisle, 9-abreast, economy-class layout, and
accommodates side-by-side placement of LD-3 containers in the cargo
compartment. The basic Model A350-900 airplane configuration
accommodates 315 passengers in a standard two-class arrangement. The
design cruise speed is Mach 0.85 with a maximum take-off weight of
602,000 lbs. The Model A350-900 series airplane has a composite wing
and fuel-tank structure constructed of carbon-fiber-reinforced plastic
materials.

Type Certification Basis

    Under Title 14, Code of Federal Regulations (14 CFR) 21.17, Airbus
must show that the Model A350-900 airplane meets the applicable
provisions of 14 CFR part 25, as amended by Amendments 25-1 through 25-
129.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Model A350-900 airplane because of
a novel or unusual design feature, special conditions are prescribed
under Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, the special conditions would also apply to the
other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Model A350-900 airplane must comply with the fuel-vent
and exhaust-emission requirements of 14 CFR part 34, and the noise-
certification requirements of 14 CFR part 36. The FAA must issue a
finding of regulatory adequacy under Sec.  611 of Public Law 92-574,
the ``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19,
under Sec.  11.38, and they become part of the type-certification basis
under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The Airbus Model A350-900 airplane will incorporate the following
novel or unusual design features: Fuel-tank NGS that is intended to
control fuel-tank flammability for all fuel tanks. This NGS is designed
to provide a level of performance that applies the more stringent
standard for warm-day flammability performance applicable to normally
emptied tanks within the fuselage contour from Sec.  25.981(b), and 14
CFR part 25 appendix M, to all fuel tanks of the Model A350-900
airplane. This high level of NGS performance for all fuel tanks is a
novel or unusual design feature not envisioned at the time the
regulations applying to the Model A350-900 airplane certification basis
were issued.

Discussion

    The certification basis of the Airbus Model A350-900 airplane
includes Sec.  25.981, as amended by Amendment 25-125, as required by
14 CFR 26.37. This amendment includes the ignition-prevention
requirements in Sec.  25.981(a), as amended by Amendment 25-102. It
includes revised flammability limits for all fuel tanks, and new
specific limitations on flammability for all fuel tanks as defined in
Sec.  25.981(b), as amended by Amendment 25-125.

Ignition Source Prevention

    Section 25.981(a)(3) requires applicants to show that an ignition
source in the fuel-tank system could not result from any single
failure, from any single failure in combination with any latent failure
condition not shown to be extremely remote, or from any combination of
failures not shown to be extremely improbable. This requirement was
originally adopted in Amendment 25-102, and it requires the assumption
that the fuel tanks are always flammable when showing that the
probability of an ignition source being present is extremely remote.
(Amendment 25-102 included Sec.  25.981(c), which required minimizing
fuel-tank flammability, and this was defined in the preamble as being
equivalent to unheated aluminum fuel tanks located in the wing.) This
requirement defines three types of scenarios that must be addressed to
show compliance with Sec.  25.981(a)(3). The first scenario is that any
single failure, regardless of the probability of occurrence of the
failure, must not cause an ignition source. The second scenario is that
any single failure, regardless of the probability of occurrence, in
combination with any latent failure condition not shown to be at least
extremely remote, must not cause an ignition source. The third scenario
is that any combination of failures not shown to be extremely
improbable must not cause an ignition source. Demonstration of
compliance with this requirement would typically require a structured,
quantitative safety analysis. Design areas that have latent failure
conditions typically would be driven by these requirements to have
multiple fault tolerance, or ``triple redundancy.'' This means that
ignition sources are still prevented even after two independent
failures.

Flammability Limits

    Section 25.981(b) states that no fuel-tank fleet-average
flammability exposure may exceed 3 percent of the flammability-exposure
evaluation time calculated using the method in part 25, Appendix N, or
the fleet-average flammability of a fuel tank within the wing of the
airplane being evaluated, whichever is greater. If the wing is not a
conventional, unheated aluminum wing, the analysis must be based on an
assumed equivalent, conventional construction, unheated, aluminum wing.
In addition, for fuel tanks that are normally emptied during operation
and that have any part of the tank located within the fuselage contour,
the fleet-average flammability for warm days (above 80 [deg]F) must be
limited to 3 percent, as calculated using the method in part 25,
Appendix M.

Application of Existing Regulations Inappropriate Due to Impracticality

    Since the issuance of Sec.  25.981(a)(3), as amended by Amendment
25-102, the FAA has conducted certification projects in which
applicants found it impractical to meet the requirements of that
regulation for some areas of lightning protection for fuel tank
structure. Partial exemptions were issued for these projects. These
same difficulties exist for the Airbus Model A350-900 airplane project.
    The difficulty of designing multiple-fault-tolerant structure, and
the difficulty of detecting failures of hidden structural-design
features in general, makes compliance with Sec.  25.981(a)(3) uniquely
challenging and impractical for certain aspects of the electrical
bonding of structural elements. Such bonding is needed to prevent
occurrence of fuel-tank ignition sources from lightning strikes. The
effectiveness and fault tolerance of electrical-bonding

features for structural joints and fasteners is partially dependent on
design features that cannot be effectively inspected or tested after
assembly without damaging the structure, joint, or fastener. Examples
of such features include a required interference fit between the shank
of a fastener and the hole in which the fastener is installed; metal
foil or mesh imbedded in composite material; a required clamping force
provided by a fastener to pull two structural parts together; and a
required faying surface bond between the flush surfaces of adjacent
pieces of structural material, such as in a wing-skin joint, or a
mounting-bracket installation. In addition, other features that
physically can be inspected or tested may be located within the fuel
tanks. Therefore, it is not practical to inspect for failures of those
features at short intervals. Examples of such failures include
separation or loosening of cap seals over fastener ends, and actual
structural failures of internal fasteners. This inability to
practically detect manufacturing errors and failures of structural-
design features critical to lightning protection results in degraded
conditions that occur and remain in place for a very long time,
possibly for the remaining life of the airplane. The complex
construction techniques associated with composite structure can make
these aspects particularly challenging.
    Accounting for such long failure-latency periods in the system
safety analysis, required by Sec.  25.981(a)(3), would require multiple
fault tolerance in the structural lightning-protection design. As part
of the design-development activity for the Model A350-900 airplane,
Airbus has examined possible design provisions to provide multiple
fault tolerance in the structural design to prevent ignition sources
from occurring in the event of lightning attachment to the airplane in
critical locations. Airbus has concluded from this examination that
providing multiple fault tolerance for some structural elements is not
practical. Airbus has also identified some areas of the Model A350-900
airplane design where it is impractical to provide even single-fault
tolerance in the structural design to prevent ignition sources from
occurring in the event of lightning attachment after a single failure.
The FAA has reviewed this examination with Airbus in detail and has
agreed that providing fault tolerance beyond that in the Model A350-900
airplane design for these areas would be impractical.
    As a result of the Airbus Model A350-900 airplane and other
certification projects, the FAA has now determined that compliance with
Sec.  25.981(a)(3) is impractical for some areas of lightning
protection for fuel-tank structure, and that application of Sec.
25.981(a)(3) to those design areas is therefore inappropriate. The FAA
plans further rulemaking to revise Sec.  25.981(a)(3). As appropriate,
the FAA plans to issue special conditions or exemptions for
certification projects progressing before the revision is complete.
This is discussed in FAA Memorandum ANM-112-08-002, Policy on Issuance
of Special Conditions and Exemptions Related to Lightning Protection of
Fuel Tank Structure, dated May 26, 2009.\1\
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    \1\ The memorandum may be viewed at: http://www.airweb.faa.gov/
RegulatoryandGuidanceLibrary/
rgPolicy.nsf/0/
12350AE62D393B7A862575C300709CA3?OpenDocument&Highlight=anm-112-08-
002
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Application of Existing Regulations Inappropriate Due to Compensating
Feature That Provides Equivalent Level of Safety

    Section 25.981(b) sets specific standards for fuel-tank
flammability as discussed above under ``Flammability Limits.'' Under
that regulation, the fleet-average flammability exposure of all fuel
tanks on the Model A350-900 airplane may not exceed 3 percent of the
flammability-exposure evaluation time calculated using the method in
part 25, Appendix N, or the fleet-average flammability of a wing main
tank within an equivalent construction, conventional, unheated,
aluminum wing fuel tank, whichever is greater. The typical fleet-
average fuel-tank flammability of fuel tanks located in the wing ranges
between 1 and 5 percent. If it is assumed that a Model A350-900
airplane equivalent, conventional, unheated, aluminum wing fuel tank
would not exceed a fleet-average flammability time of 3 percent, the
actual composite Model A350-900 airplane wing-fuel-tank design would be
required to comply with the 3 percent fleet average flammability
standard, and therefore a means to reduce the flammability to 3 percent
would be required. However, the Model A350-900 airplane design includes
NGS for all fuel tanks that will also be shown to meet the additional,
more-stringent warm-day average flammability standard in part 25,
Appendix M, which is only required for normally emptied fuel tanks with
some part of the tank within the fuselage contour. Fuel tanks that meet
this requirement typically have average fuel-tank flammability levels
well below the required 3 percent.
    Since the NGS for all fuel tanks on the Model A350-900 airplane
provides performance that meets part 25, Appendix M, the FAA has
determined that the risk reduction provided by this additional
performance will provide compensation for some relief from the
ignition-prevention requirements of Sec.  25.981(a)(3) while still
establishing a level of safety equivalent to that established in the
regulations.
    In determining the appropriate amount of relief from the ignition-
prevention requirements of Sec.  25.981(a), the FAA considered the
original overall intent of Amendment 25-102, which was to ensure the
prevention of catastrophic events due to fuel-tank vapor explosion.
These special conditions are intended to achieve that objective through
a prescriptive requirement that fault tolerance (with respect to the
creation of an ignition source) be provided for all structural
lightning protection design features where providing such fault
tolerance is practical, and through a performance-based standard for
the risk due to any single-failure vulnerability that exists in the
design. In addition, for any structural lightning-protection design
features for which Airbus shows that providing fault tolerance is
impractical, these special conditions require Airbus to show that a
fuel-tank vapor-ignition event, due to the summed risk of all non-
fault-tolerant design features, is extremely improbable. Airbus would
be required to show that the design meets this safety objective using a
structured system-safety assessment similar to that currently used for
demonstrating compliance with Sec. Sec.  25.901 and 25.1309.
    Given these novel or unusual design features, and the compliance
challenges noted earlier in this document, the FAA has determined that
application of Sec.  25.981(a)(3) is inappropriate in that it is
neither practical nor necessary to apply the ignition-source-prevention
provisions of Sec.  25.981(a)(3) to the specific fuel-tank structural
lightning-protection features of the Airbus Model A350-900 airplane.
However, without the Sec.  25.981(a)(3) provisions, the remaining
applicable regulations in the Model A350-900 airplane certification
basis would be inadequate to set an appropriate standard for fuel-tank
ignition prevention. Therefore, in accordance with provisions of Sec.
21.16, the FAA has determined that, instead of Sec.  25.981(a)(3),
alternative fuel-tank structural lighting-protection requirements be
applied to fuel-tank lightning-protection features that are integral to
the airframe structure of the

Model A350-900 airplane. These alternative requirements are intended to
provide the level of safety intended by Sec.  25.981(a)(3), based on
our recognition, as discussed above, that a highly effective NGS for
the fuel tanks makes it unnecessary to assume that the fuel tank is
always flammable. As discussed previously, the assumption that the fuel
tanks are always flammable was required when demonstrating compliance
to the ignition-prevention requirements of Sec.  25.981(a)(3).
    One resulting difference between these special conditions and the
Sec.  25.981(a)(3) provisions they are meant to replace is the outcome
being prevented--fuel-vapor ignition versus an ignition source. These
special conditions acknowledge that the application of fuel-tank-
flammability performance standards will reduce fuel-tank flammability
to an extent that it is appropriate to consider the beneficial effects
of flammability reduction when considering design areas where it is
impractical to comply with Sec.  25.981(a)(3).
    One of the core requirements of these special conditions is a
prescriptive requirement that structural lightning-protection design
features must be fault tolerant. (An exception, wherein Airbus can show
that providing fault tolerance is impractical, and associated
requirements, is discussed below.) The other core requirement is that
Airbus must show that the design, manufacturing processes, and
Airworthiness Limitations section of the Instructions for Continued
Airworthiness include all practical measures to prevent, and detect and
correct, failures of structural-lightning protection features due to
manufacturing variability, aging, wear, corrosion, and likely damage.
The FAA has determined that, if these core requirements are met, a
fuel-tank vapor-ignition event, due to lightning, is not anticipated to
occur in the life of the airplane fleet. This conclusion is based on
the fact that a critical lightning strike to any given airplane is
itself a remote event, and on the fact that fuel tanks must be shown to
be flammable only for a relatively small portion of the fleet
operational life.
    For any non-fault-tolerant features in the design, Airbus must show
that eliminating these features or making them fault tolerant is
impractical. The requirements and considerations for showing it is
impractical to provide fault tolerance are described in FAA Memorandum
ANM-112-08-002. This requirement is intended to minimize the number of
non-fault-tolerant features in the design.
    For areas of the design where Airbus shows that providing fault-
tolerant structural lighting-protection features is impractical, non-
fault-tolerant features will be allowed, provided Airbus can show that
a fuel-tank vapor-ignition event, due to the non-fault-tolerant
features, is extremely improbable when the sum of probabilities of
those events, due to all non-fault-tolerant features, is considered.
Airbus will be required to submit a structured, quantitative assessment
of fleet-average risk for a fuel-tank vapor-ignition event due to all
non-fault-tolerant design features included in the design. This will
require determination of the number of non-fault-tolerant design
features, estimates of the probability of the failure of each non-
fault-tolerant design feature, and estimates of the exposure time for
those failures. This analysis must include failures due to
manufacturing variability, aging, wear, corrosion, and likely damage.
    It is acceptable to consider the probability of fuel-tank
flammability, the probability of a lightning strike to the airplane,
the probability of a lightning strike to specific zones of the airplane
(for example, Zone 2 behind the nacelle, but not a specific location or
feature), and a distribution of lightning-strike amplitude in
performing the assessment, provided the associated assumptions are
acceptable to the FAA. The analysis must account for any dependencies
among these factors, if they are used. The assessment must also account
for operation with inoperative features and systems, including any
proposed or anticipated dispatch relief. This risk-assessment
requirement is intended to ensure that an acceptable level of safety is
provided given the non-fault-tolerant features in the design.
    Part 25, Appendix N, as adopted in Amendment 25-125, in conjunction
with these special conditions, constitutes the standard for how to
determine flammability probability. In performing the safety analysis
required by these special conditions, relevant Sec.  25.981(a)(3)
compliance guidance is still applicable. Appropriate credit for the
conditional probability of environmental or operational conditions
occurring is normally limited to those provisions involving multiple
failures, and this type of credit is not normally allowed in evaluation
of single failures. However, these special conditions would allow
consideration of the probability of occurrence of lightning attachment
and flammable conditions when assessing the probability of structural
failures resulting in a fuel-tank vapor-ignition event.
    The FAA understands that lightning-protection safety for airplane
structure is inherently different from lightning protection for
systems. We intend to apply these special conditions only to structural
lightning-protection features of fuel systems. We do not intend to
apply the alternative standards used under these special conditions to
other areas of the airplane-design evaluation.

Requirements Provide Equivalent Level of Safety

    In recognition of the unusual design feature discussed above, and
the impracticality of requiring multiple fault tolerance for lightning
protection of certain aspects of fuel-tank structure, the FAA has
determined that a level of safety equivalent to direct compliance with
Sec.  25.981(a)(3) will be achieved for the Model A350-900 airplane by
applying these requirements. The FAA considers that, instead of only
concentrating on fault tolerance for ignition-source prevention,
significantly reducing fuel-tank flammability exposure, in addition to
preventing ignition sources, is a better approach to lightning
protection for the fuel tanks. In addition, the level of average fuel-
tank flammability achieved by compliance with these special conditions
is low enough that it is not appropriate or accurate to assume, in a
safety analysis, that the fuel tanks may always be flammable.
    Section 25.981(b), as amended by Amendment 25-125, sets limits on
the allowable fuel-tank flammability for the Model A350-900 airplane.
Condition 2(a) of these special conditions applies the more-stringent
standard, for warm-day flammability performance applicable to normally
emptied tanks within the fuselage contour, from Sec.  25.981(b) and
part 25, Appendix M, to all of the fuel tanks of the Model A350-900
airplane.
    Because of the more-stringent fuel-tank flammability requirements
in these special conditions, and because the flammability state of a
fuel tank is independent of the various failures of structural elements
that could lead to an ignition source in the event of lightning
attachment, the FAA has agreed that it is appropriate in this case to
allow treatment of flammability as an independent factor in the safety
analysis. The positive control of flammability, and the lower
flammability that is required by these special conditions, exceed the
minimum requirements of Sec.  25.981(b). This offsets a reduction of
the stringent standard for ignition-source prevention in Sec.
25.981(a)(3), which assumes that the fuel tank is flammable at all
times.

    Given the stringent requirements for fuel-tank flammability, the
fuel-vapor ignition prevention, and the ignition-source prevention
requirements in these special conditions will prevent ``. . .
catastrophic failure . . . due to ignition of fuel or vapors,'' as
stated in Sec.  25.981(a). Thus, the overall level of safety achieved
by these special conditions is considered equivalent to that which
would be required by compliance with Sec.  25.981(a)(3) and (b).
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Discussion of Comments

    Notice of proposed special conditions No. 25-13-36-SC for Airbus
Model A350-900 series airplanes was published in the Federal Register
on December 19, 2013 (78 FR 76775). No comments were received, and the
special conditions are adopted as proposed.

Applicability

    As discussed above, these special conditions apply to Airbus Model
A350-900 series airplanes. Should Airbus apply later for a change to
the type certificate to include another model incorporating the same
novel or unusual design feature, the special conditions would apply to
that model as well.

Conclusion

    This action affects only certain novel or unusual design features
on the Airbus Model A350-900 series airplanes. It is not a rule of
general applicability.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

0
Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type-certification basis for Airbus Model A350-900 series
airplanes.

1. Definitions

    Most of the terms used in the special conditions described in
Alternative Fuel Tank Structural Lightning Protection Requirements
either have the common dictionary meaning or are defined in Advisory
Circular 25.1309-1A, System Design and Analysis, dated June 21, 1988.
    The following definitions are the only terms intended to have a
specialized meaning when used in these special conditions:
    (a) Basic Airframe Structure. Includes design elements such as
structural members, structural joint features, and fastener systems
including airplane skins, ribs, spars, stringers, etc., and associated
fasteners, joints, coatings, and sealant. Basic airframe structure may
also include those structural elements that are expected to be removed
for maintenance, such as exterior fuel-tank access panels and fairing-
attachment features, provided maintenance errors that could compromise
associated lightning-protection features would be evident upon an
exterior, preflight inspection of the airplane and would be corrected
prior to flight.
    (b) Permanent System-Supporting Structure. Includes static,
permanently attached structural parts (such as brackets) that are used
to support system elements. It does not include any part intended to be
removed, or any joint intended to be separated, to maintain or replace
system elements or other parts, unless that part removal or joint
separation is accepted by the FAA as being extremely remote.
    (c) Manufacturing Variability. Includes tolerances and variability
that the design and production specifications allow, as well as
anticipated errors or escapes from the manufacturing and inspection
processes.
    (d) Extremely Remote. Conditions that are not anticipated to occur
to each airplane during its total life, but which may occur a few times
when considering the total operational life of all airplanes of one
type. Extremely remote conditions are those having an average
probability per flight hour on the order of 1 x 10-\7\ or
less, but greater than on the order of 1 x 10-\9\.
    (e) Extremely Improbable. Conditions that are so unlikely that they
are not anticipated to occur during the entire operational life of all
airplanes of one type. Extremely improbable conditions are those having
an average probability per flight hour of the order of 1 x
10-\9\ or less.

2. Alternative Fuel-Tank Structural Lightning-Protection Requirements

    For lightning-protection features that are integral to fuel-tank
basic airframe structure or permanent system-supporting structure, as
defined in this these special conditions Definitions, for which Airbus
shows and the FAA finds compliance with Sec.  25.981(a)(3) to be
impractical, the following requirements may be applied in lieu of the
requirements of Sec.  25.981(a)(3):
    (a) Airbus must show that the airplane design meets the
requirements of part 25, Appendix M, as amended by Amendment 25-125,
for all fuel tanks installed on the airplane.
    (b) Airbus must show that the design includes at least two
independent, effective, and reliable lightning-protection features (or
sets of features) such that fault tolerance to prevent lightning-
related ignition sources is provided for each area of the structural
design to be shown compliant with these special conditions in lieu of
compliance with the requirements of Sec.  25.981(a)(3). Fault tolerance
is not required for any specific design feature if:
    (1) For that feature, providing fault tolerance is shown to be
impractical, and
    (2) Fuel-tank vapor ignition due to that feature and all other non-
fault-tolerant features, when their fuel-tank vapor-ignition event
probabilities are summed, is shown to be extremely improbable.
    (c) Airbus must perform an analysis to show that the design,
manufacturing processes, and airworthiness limitations section of the
instructions for continued airworthiness include all practical measures
to prevent, and detect and correct, failures of structural lightning-
protection features due to manufacturing variability, aging, wear,
corrosion, and likely damage.

    Issued in Renton, Washington, on August 15, 2014.
Jeffrey E. Duven,
Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2014-21245 Filed 9-5-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Proposed Rules]
[Pages 23737-23739]
[FR Doc No: 2015-09816]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0593; Directorate Identifier 2015-NE-08-AD]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc Turbofan Engines

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 all
Rolls-Royce plc (RR) RB211-535E4-37, RB211-535E4-B-37, and RB211-535E4-
C-37 turbofan engines. This proposed AD was prompted by RR updating the
life limits for certain high-pressure turbine (HPT) disks. This
proposed AD would require reducing the cyclic life limits for certain
HPT disks, removing those disks that have exceeded the new life limit,
and replacing them with serviceable parts. We are proposing this AD to
prevent failure of the HPT disk, which could result in uncontained disk
release, damage to the engine, and damage to the airplane.

DATES: We must receive comments on this proposed AD by June 29, 2015.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    For service information identified in this proposed AD, Rolls-Royce
plc, Corporate Communications, P.O. Box 31, Derby, England, DE24 8BJ;
phone: 011-44-1332-242424; fax: 011-44-1332-249936; email: http://www.rolls-royce.com/contact/civil_team.jsp; Internet: https://www.aeromanager.com. You may view this service information at the FAA,
Engine & Propeller Directorate, 12 New England Executive Park,
Burlington, MA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

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-
0593; 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 this proposed AD, the mandatory continuing airworthiness
information (MCAI), the regulatory evaluation, any comments received,
and other information. The address for the Docket Office (phone: 800-
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Wego Wang, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:
781-238-7199; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-0593;
Directorate Identifier 2015-NE-08-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 based on 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
with FAA personnel concerning this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD 2014-0249R1, dated February 18, 2015 (referred to hereinafter as
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    An engineering analysis, carried out by RR, of the lives of
critical parts of the RB211-535E4-37 engine, has resulted in reduced
cyclic life limits for certain high pressure (HP) turbine discs. The
reduced limits are published in the RR RB211-535E4-37 Time Limits
Manual (TLM): 05-10-01-800-000, current Revision dated July 2014.
    Operation of critical parts beyond these reduced cyclic life
limits may result in part failure, possibly resulting in the release
of high-energy debris, which may cause damage to the aeroplane and/
or injury to the occupants.

    You may obtain further information by examining the MCAI in the AD
docket on the Internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2015-0593.

Related Service Information Under 1 CFR Part 51

    We reviewed RR Non-Modification Service Bulletin (NMSB) No. RB.211-
72-G188, Revision No. 1, dated October 30, 2013, and RR RB211-535E4-37,
Time Limits Manual (TLM): 05-10-01-800-000, Revision dated July 1,
2014; and RR RB211-535E4-37, TLM: 05-00-01-800-000, Revision dated July
1, 2014. The NMSB describes the updated lifing analysis of the affected
HP turbine disks. The TLMs provide revised life limits for the affected
HP turbine disks. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or see ADDRESSES for other ways to access this
service information.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of the
United Kingdom, and is approved for operation in the United States.
Pursuant to our bilateral agreement with the European Community, EASA
has notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all

information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design. This proposed AD would require reducing the cyclic life limits
for certain HPT disks, removing those disks that have exceeded the new
life limit, and replacing them with serviceable parts.

Costs of Compliance

    We estimate that this proposed AD affects 650 engines installed on
airplanes of U.S. registry. We also estimate that it would take about 0
hours per engine to comply with this proposed AD. The average labor
rate is $85 per hour. Pro-rated cost of required parts cost would be
about $12,213 per engine. Based on these figures, we estimate the cost
of this proposed AD on U.S. operators to be $7,938,450.

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 to the extent
that it justifies making a regulatory distinction, 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):

    Rolls-Royce plc: Docket No. FAA-2015-0593; Directorate
Identifier 2015-NE-08-AD.

(a) Comments Due Date

    We must receive comments by June 29, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Rolls-Royce plc (RR), RB211-535E4-37,
RB211-535E4-B-37, and RB211-535E4-C-37 turbofan engines.

(d) Reason

    This AD was prompted by RR updating the life limits for certain
high-pressure turbine (HPT) disks. We are issuing this AD to prevent
failure of the HPT disk, which could result in uncontained disk
release, damage to the engine, and damage to the airplane.

(e) Actions and Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) After the effective date of this AD, use RR RB211-535E4-37
Time Limits Manual (TLM): 05-10-01-800-000, Revision dated July 1,
2014 (referred to hereafter as `the TLM'), to determine the new life
limits for the affected engine models and configurations, with the
exception of those engine models mentioned in paragraph (e)(2) of
this AD.
    (2) For RR RB211-535E4-B-37 or RB211-535E4-C-37 engines with an
affected HPT disk that was previously installed on an RB211-535E4-37
engine operated under Flight Plan A, use task 05-00-01-800-000 in
the TLM to re-calculate equivalent cycles since new to obtain the
new life limit.
    (3) If an affected engine model has an HPT disk installed with
P/N UL27681 or UL39767, remove the affected HPT disk before the
accumulated cyclic life exceeds either 19,500 flight cycles (FCs)
under Flight Plan A, or 14,700 FCs under Flight Plan B, or within 25
FCs after the effective date of this AD, whichever occurs later.
    (4) For all affected engines, other than those specified in
paragraph (e)(3) in this AD, remove each HPT disk before exceeding
its applicable life limit as specified in the TLM.
    (5) Install an HPT disk eligible for installation.

(f) Definition

    For the purpose of this AD, a part eligible for installation is
one with a part number listed in the TLM with a total accumulated
cyclic life that is less than the applicable life limit specified in
the TLM.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
for this AD. Use the procedures found in 14 CFR 39.19 to make your
request. You may email your request to<EMAIL_ADDRESS>
(h) Related Information

    (1) For more information about this AD, contact Wego Wang,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to MCAI European Aviation Safety Agency AD 2014-
0249R1, dated February 18, 2015, for more information. You may
examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No.
FAA-2015-0593.
    (3) RR Non-Modification Service Bulletin No. RB.211-72-G188,
Revision No. 1, dated October 30, 2013, and RR RB211-535E4-37, TLM:
05-10-01-800-000, Revision dated July 1, 2014; and RR RB211-535E4-
37, TLM: 05-00-01-800-000, Revision dated July 1, 2014, which are
not incorporated by reference in this AD, can be obtained from
Rolls-Royce plc, using the contact information in paragraph (h)(4)
of this proposed AD.
    (4) For service information identified in this proposed AD,
contact Rolls-Royce plc, Corporate Communications, P.O. Box 31,
Derby, England, DE24 8BJ; phone: 011-44-1332-242424; fax: 011-44-
1332-249936; email: http://www.rolls-royce.com/contact/civil_team.jsp; Internet: https://www.aeromanager.com.
    (5) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on April 22, 2015.
Colleen M. D'Alessandro,
Assistant Directorate Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2015-09816 Filed 4-28-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Rules and Regulations]
[Pages 3605-3610]
[FR Doc No: 2018-01487]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0333; FRL-9970-88]

Chlorfenapyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-
(trifluromethyl)-1H-pyrrole-3-carbonitrile, in or on tea, dried. BASF
Corporation requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 26, 2018. Objections and
requests for hearings must be received on or before March 27, 2018, 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-2016-0333, 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: Michael L. Goodis, P.E., Director,
Registration Division (750P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001;

main telephone number:<PHONE_NUMBER>; email address:
[email protected].

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.

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-2016-0333 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
March 27, 2018. 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-2016-0333, 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 July 20, 2016 (81 FR 47150) (FRL-9948-
45), 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
6E8473) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.513 be amended by
establishing tolerances for residues of the insecticide chlorfenapyr,
4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluromethyl)-1H-
pyrrole-3-carbonitrile, in or on tea, dried at 70 parts per million
(ppm). That document referenced a summary of the petition prepared by
BASF Corporation, the registrant, which is available in the docket,
http://www.regulations.gov. This tolerance was requested to cover
residues of chlorfenapyr in or on tea resulting from uses of this
pesticide on tea outside the United States. There is no current U.S.
registration for use of chlorfenapyr on tea. In addition, there were no
substantive comments received in response to the notice of filing.

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 chlorfenapyr including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with chlorfenapyr 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. Chlorfenapyr has moderate acute toxicity via the oral route
of exposure and low acute toxicity via the dermal and inhalation routes
of exposure. It is a mild eye irritant, but it is not a dermal irritant
or sensitizer. Chlorfenapyr targets the central nervous system (CNS),
inducing neurohistological changes (spongiform myelinopathy of the
brain and spinal cord and vacuolization of the brain, spinal cord, and
optic nerve) from subchronic and chronic dietary administration in mice
and rats. In addition to neuropathology, rats also exhibited
neurobehavioral changes on the day of dosing in the acute neurotoxicity
study. Decreased motor activity was observed in the acute neurotoxicity
study as well as in offspring in the developmental neurotoxicity (DNT)
study. Several rat studies also noted effects in the liver (increased
organ weights and tumors) at doses similar to or above those where CNS
effects were seen. The liver was identified in metabolism studies as
the single organ to have the highest recovery of administered dose.
    There was evidence of increased quantitative susceptibility to
offspring in the database as a result of chlorfenapyr exposure. In the
two-

generation reproduction study, decreased pup weights were seen at a
lower dose than parental toxicity (decreased body-weight). In the DNT
study, offspring toxicity (decreased motor activity and increased pup
deaths on postnatal days 1-4) was seen in the absence of maternal
toxicity. Additional effects on the CNS (vacuolation of white matter in
the brain and decreased hippocampus size) were also observed in
offspring at a higher dose in this study. There was no evidence of
increased susceptibility to offspring in the developmental toxicity
studies. In both the rat and rabbit developmental toxicity studies,
although no maternal or developmental effects were noted up to the
highest doses tested (HDT), maternal observations are limited in these
developmental studies. Consequently, the data from the DNT are
considered more robust for assessing the effects of chlorfenapyr on the
nervous system.
    Given the lack of toxicity in the rat and rabbit developmental
studies, the early pup deaths in the reproduction toxicity and DNT
studies are suspected to be the result of postnatal exposure through
lactation. Chlorfenapyr has a relatively high octanol-water partition
coefficient (log KOW = 4.83) and has been shown to
accumulate in milk due to its lipophilic nature in a dietary cow study.
In addition, in a rat metabolism study, chlorfenapyr was found to
accumulate in the fat, such that females exhibited greater accumulation
than males. This suggests chlorfenapyr is capable of accumulating in
breast milk and likely causing the early pup deaths seen in the
reproduction toxicity and DNT studies through lactation.
    Chlorfenapyr did not show any evidence of mutagenicity in in vitro
or in vivo studies. Chlorfenapyr is classified as ``suggestive evidence
of carcinogenicity, but not sufficient to assess human carcinogenic
potential.''
    Specific information on the studies received and the nature of the
adverse effects caused by chlorfenapyr as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document entitled ``Chlorfenapyr: Revised
Preliminary Human Health Risk Assessment for Registration Review,''
dated September 7, 2016, which can be found in docket ID number EPA-HQ-
OPP-2010-0467 as well in the document completed in support of this
tolerance action entitled ``Chlorfenapyr. Human Health Risk Assessment
for the Establishment of a Tolerance without a U.S. Registration for
Residues in/on Imported Tea,'' dated March 1, 2017, which can be found
in docket ID number EPA-HQ-OPP-2016-0333.

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 chlorfenapyr used for human risk assessment is shown in
Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Chlorfenapyr for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RFD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute Dietary (All populations)..  NOAEL = 5 mg/kg/day.  Acute RfD = 0.05 mg/ Developmental Neurotoxicity Study
                                   UFA = 10X...........   kg/day.              (Rat).
                                   UFH = 10X...........  aPAD = 0.05 mg/kg/   LOAEL = 10 mg/kg/day based on
                                   FQPA SF = 1X........   day.                 increased pup deaths (post-natal
                                                                               days 1-4) and decreased motor
                                                                               activity.
                                  ------------------------------------------------------------------------------
Chronic Dietary (All populations)  NOAEL = 5 mg/kg/day.  Chronic RfD = 0.05   Developmental Neurotoxicity Study
                                   UFA = 10X...........   mg/kg/day.           (Rat).
                                   UFH = 10X...........  cPAD = 0.05 mg/kg/   LOAEL = 10 mg/kg/day based on
                                   FQPA SF = 1X........   day.                 increased pup deaths (post-natal
                                                                               days 1-4) and decreased motor
                                                                               activity.
                                                                              Chronic Neurotoxicity Study (Rat).
                                                                              NOAEL = 2.6 mg/kg/day.
                                                                              LOAEL = 13.6 mg/kg/day based on
                                                                               alterations of the myelin of the
                                                                               CNS and decreased water
                                                                               consumption in male rats,
                                                                               decreased food consumption in
                                                                               females, and decreased body-
                                                                               weight in both sexes.
                                  ------------------------------------------------------------------------------
Incidental Oral Short-Term (1-30   NOAEL = 5 mg/kg/day.  Residential LOC for  Developmental Neurotoxicity Study
 days) and Intermediate-Term (1-6  UFA = 10X...........   MOE = 100.           (Rat).
 months).                          UFH = 10X...........                       LOAEL = 10 mg/kg/day based on
                                   FQPA SF = 1X........                        increased pup deaths (post-natal
                                                                               days 1-4) and decreased motor
                                                                               activity.
                                  ------------------------------------------------------------------------------

Dermal Short-Term (1-30 days) and  NOAEL = 5 mg/kg/day.  Residential LOC for  Developmental Neurotoxicity Study
 Intermediate-Term (1-6 months).   UFA = 10X...........   MOE = 100.           (Rat).
                                   UFH = 10X...........                       LOAEL = 10 mg/kg/day based on
                                   FQPA SF = 1X........                        increased pup deaths (post-natal
                                                                               days 1-4) and decreased motor
                                                                               activity.
                                  ------------------------------------------------------------------------------
Inhalation Short-Term (1-30 days)  NOAEL = 5 mg/kg/day.  Residential LOC for  Developmental Neurotoxicity Study
 and Intermediate-Term (1-6        UFA = 10X...........   MOE = 100.           (Rat).
 months).                          UFH = 10X...........                       LOAEL = 10 mg/kg/day based on
                                   FQPA SF = 1X........                        increased pup deaths (post-natal
                                                                               days 1-4) and decreased motor
                                                                               activity.
                                  ------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)  Classified as ``suggestive evidence of carcinogenicity, but not sufficient to
                                    assess human carcinogenic potential.'' The Agency determined that
                                    quantification of risk using a non-linear approach (i.e., using a cRfD)
                                    adequately accounts for all chronic toxicity, including carcinogenicity that
                                    could result from exposure to chlorfenapyr.
----------------------------------------------------------------------------------------------------------------
NOAEL = no-observed adverse-effect level. LOAEL = lowest-observed adverse-effect level. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population-adjusted dose
  (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to chlorfenapyr, EPA considered exposure under the petitioned-
for tolerances as well as all existing chlorfenapyr tolerances in 40
CFR 180.513. EPA assessed dietary exposures from chlorfenapyr in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for chlorfenapyr. In estimating acute dietary (food only) exposure, EPA
used the Dietary Exposure Evaluation Model--Food Consumption Intake
Database (DEEM-FCID), Version 3.16, which uses food consumption data
from the U.S. Department of Agriculture's National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA) from 2003-
2008. As to residue levels in food, EPA's acute analysis was unrefined
and used tolerance-level residues and 100% crop-treated (PCT).
Tolerances for food/feed handling establishments are not included in
the acute dietary assessment unless the food/feed handling
establishment is the only use; however, this is not the case for
chlorfenapyr. DEEM 7.81 default processing factors were used in the
acute analysis for tomato commodities as there is a registered
agricultural use on fruiting vegetables.
    ii. Chronic exposure. In conducting the chronic dietary (food only)
risk assessment, EPA used the DEEM-FCID, Version 3.16, which uses food
consumption data from the U.S. Department of Agriculture's NHANES/WWEIA
from 2003-2008. As to residue levels in food, EPA's chronic dietary
exposure analysis for the all population subgroups was unrefined and
used tolerance-level residues and 100% PCT. As most tolerances for
chlorfenapyr are for food or feed handling establishment uses and
residues are expected to be incurred after processing, DEEM 7.81
processing factors were set to 1 for all commodities except tomato
commodities (as there is a registered agricultural use on fruiting
vegetables). For tomato commodities, default processing factors were
used in the analysis.
    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.
Cancer risk is 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 a nonlinear approach using the chronic
RfD for assessing cancer risk is appropriate for chlorfenapyr;
therefore, a separate quantitative cancer risk assessment is
unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for chlorfenapyr. Tolerance level residues and/or
100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The acute and chronic
dietary analysis did not include exposure from drinking water as
contamination of drinking water with chlorfenapyr as a result of all
registered uses, including greenhouses, is not expected to occur.
Furthermore, as there are no U.S. registrations for tea, a dietary
exposure assessment from drinking water is not needed.
    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). Chlorfenapyr is
currently registered for the following uses that could result in
residential exposures: crack/crevice/spot treatment on indoor and
outdoor residential sites (including as a bed bug treatment).
Residential exposures are not expected to occur from use of
chlorfenapyr on tea since chlorfenapyr will not be applied to tea in
the United States. Further information regarding EPA standard
assumptions and generic inputs for residential exposures may be

found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 chlorfenapyr to share a common mechanism of
toxicity with any other substances, and chlorfenapyr does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
chlorfenapyr does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. Although there is evidence
of increased quantitative susceptibility, concern is low since the
offspring effects are well-characterized with clearly established
NOAEL/LOAEL values and the endpoints selected for risk assessment are
protective of observed offspring effects, including those observed in
lactating pups.
    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 chlorfenapyr is complete.
    ii. Although the central nervous system is the primary target for
chlorfenapyr and neurotoxic effects were observed across studies,
concern is low since the selected PODs are protective of observed
neurotoxic effects.
    iii. Although there is evidence of increased quantitative
susceptibility, concern is low since the offspring effects are well-
characterized with clearly established NOAEL/LOAEL values and the
endpoints selected for risk assessment are protective of observed
offspring effects.
    iv. There are no residual uncertainties identified in the exposure
databases. The acute and chronic analysis did not include exposure from
drinking water as contamination of drinking water with chlorfenapyr as
the result of all registered uses, including greenhouses, is not
expected to occur. Furthermore, as there is no U.S. registration for
tea, a dietary exposure assessment from drinking water is not needed.
EPA used similarly conservative assumptions to assess post-application
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by chlorfenapyr.

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 the acute exposure assumptions discussed in this unit for acute
exposure, the resulting acute (food only) risk estimates were less than
EPA's LOC (<100% of the aPAD) for the general U.S. population (15% of
the aPAD) and all population subgroups. The most highly exposed
population subgroup was children 1 to 2 years old with an estimated
equivalent risk to 36% of the aPAD; therefore, the acute dietary
exposure to chlorfenapyr is below the Agency's LOC.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that the resulting chronic
risk estimate utilizes 4.6% of the cPAD for the general U.S.
population. The most highly-exposed population subgroup was children 1
to 2 years old which utilized 9.9% of the cPAD; therefore, the chronic
dietary exposure to chlorfenapyr for all population subgroups is below
the Agency's LOC. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
chlorfenapyr is not expected.
    3. Short- and Intermediate-term risk. Short- and intermediate-term
aggregate risk assessments were performed since there is potential for
post-application exposure from the previously registered uses of
chlorfenapyr in residential settings. Since the short- and
intermediate-term endpoints and PODs are the same, the short-term
aggregate assessment is protective of intermediate-term exposure. The
short-term aggregate MOE of 840 for adults is greater than the LOC
(100), and is, therefore, not a concern. For children (1 to <2 years
old), the most highly exposed population subgroup, the short-term
aggregate MOE of 140 is greater than the LOC (100), and is, therefore,
not a concern.
    4. Aggregate cancer risk for U.S. population. As discussed in Unit
III. C.1.iii., EPA concluded that regulation based on the cRfD will be
protective for both chronic and carcinogenic risks. As noted in this
unit, there are no chronic risks of concern; therefore, the Agency
concludes that aggregate exposure to chlorfenapyr will not pose a
cancer risk.
    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 chlorfenapyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The enforcement method is designated as M 2427, a gas
chromatography/electron capture detection (GC/ECD) method with a limit
of quantitation (LOQ) of 0.05 ppm. Method M 2427 has been subjected to
a successful independent laboratory validation (ILV) as well as an
acceptable radiovalidation using samples obtained from lettuce and
tomato metabolism studies. This method is adequate for data collection
and tolerance enforcement purposes.

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 not established a MRL for chlorfenapyr in or
on tea, dried.

C. Revisions to Petitioned-for Tolerances

    EPA is establishing a tolerance for ``tea, dried'', as opposed to
``tea'' as requested by the petitioner, for consistency with the
Agency's food and feed commodity vocabulary. In addition, EPA is
amending the introductory text of paragraph (a)(1) to be consistent
with the Agency's policy for drafting the tolerance expression. These
revisions reflect the language in FFDCA section 408(a)(3), which
includes metabolites and degradates of a pesticide chemical under the
same tolerance unless otherwise excluded, as well as providing greater
clarity for measuring residues to determine compliance. These revisions
do not substantively change the existing tolerances in paragraph
(a)(3).

V. Conclusion

    Therefore, a tolerance is established without U.S. registrations
for residues of chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-
(ethoxymethyl)-5-(trifluromethyl)-1H-pyrrole-3-carbonitrile, in or on
tea, dried at 70 parts per million.

VI. Statutory and Executive Order Reviews

    This action establishes 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); Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). 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: December 18, 2017.
Michael Goodis,
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.  180.513, revise paragraph (a)(1) to read as follows:

Sec.  180.513   Chlorfenapyr; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of
chlorfenapyr, 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 chlorfenapyr, 4-
bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1H-
pyrrole-3-carbonitrile, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Tea, dried \1\..............................................          70
Vegetable, fruiting, group 8-10.............................         1.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations for Tea, dried as of January 26,
  2018.

* * * * *
[FR Doc. 2018-01487 Filed 1-25-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: August 11, 2006 (Volume 71, Number 155)]
[Notices]
[Page 46216-46217]
[DOCID:fr11au06-56]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Docket No. EL06-96-000]

Michigan South Central Power Agency; Notice of Filing

August 4, 2006.
    Take notice that on August 1, 2006, pursuant to section 205 of the
Federal Power Act, 16 U.S.C. 824d, and 18 CFR Part 35 of the
Commission's regulations, Michigan South Central Power Agency filed its
revenue requirement and supporting data for the provision of cost-based
Reactive Supply and Voltage Control under Schedule 2 of the Midwest
Independent Transmission System Operator, Inc.'s Transmission and
Energy Markets Tariff, to be effective October 1, 2006, pursuant to 18
CFR 35.3 of the Commission's requirements.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, SE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

    Comment Date: 5 p.m. Eastern Time on August 31, 2006.
Magalie R. Salas,
Secretary.
 [FR Doc. E6-13140 Filed 8-10-06; 8:45 am]

BILLING CODE 6717-01-P