[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Rules and Regulations]
[Pages 55521-55527]
[FR Doc No: 2015-23121]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-1071; Directorate Identifier 2013-NM-204-AD;
Amendment 39-18264; AD 2015-19-01]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 777 airplanes. This AD was prompted by reports
of latently failed fuel shutoff valves discovered during fuel filter
replacement. This AD requires revising the maintenance or inspection
program to include a new airworthiness limitation. We are issuing this
AD to detect and correct latent failures of the

fuel shutoff valve to the engine, which could result in the inability
to shut off fuel to the engine and, in case of certain engine fires, an
uncontrollable fire that could lead to wing failure.

DATES: This AD is effective October 21, 2015.

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-2013-
1071; 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 AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Rebel Nichols, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6509; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all The Boeing Company
Model 777 airplanes. The NPRM published in the Federal Register on
January 10, 2014 (79 FR 1772). The NPRM was prompted by reports of
latently failed fuel shutoff valves discovered during fuel filter
replacement. The NPRM proposed to require revising the maintenance or
inspection program to include a new airworthiness limitation. We are
issuing this AD to detect and correct latent failures of the fuel
shutoff valve to the engine, which could result in the inability to
shut off fuel to the engine and, in case of certain engine fires, an
uncontrollable fire that could lead to wing failure.

Record of Ex Parte Communication

    In preparation of AD actions such as NPRMs and immediately adopted
rules, it is the practice of the FAA to obtain technical information
and information on operational and economic impacts from design
approval holders and aircraft operators. We discussed certain comments
addressed in this final rule in a teleconference with Airlines for
America (A4A) and other members of the aviation industry. All of the
comments discussed during this teleconference that are relevant to this
final rule are addressed in this final rule in response to comments
submitted by other commenters. A discussion of this contact can be
found in the rulemaking docket at http://www.regulations.gov by
searching for and locating Docket No. FAA-2013-1071.

Clarification of Certain Terminology

    Throughout the preamble of this final rule, commenters may have
used the terms ``fuel shutoff valve'' and ``fuel spar valve''
interchangeably. Both terms refer to the same part. In our responses to
comments, we have used the term ``fuel shutoff valve.'' The term ``fuel
spar valve'' is more commonly used in airplane maintenance
documentation and, therefore, we have used that term in figure 1 to
paragraph (g) of this AD.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM (79
FR 1772, January 10, 2014) and the FAA's response to each comment.

Request To Withdraw the NPRM (79 FR 1772, January 10, 2014)

    American Airlines (AA) stated that Boeing's internal review found
that the issue addressed by the NPRM (79 FR 1772, January 10, 2014) is
not a safety concern, and that Boeing has not recommended any interim
action on this issue. In addition, AA stated that Boeing is addressing
the issue in the long term with a design change to the motor-operated
valve (MOV) actuator. We infer AA is requesting that the NPRM be
withdrawn.
    We disagree with the commenter's request to withdraw the NPRM (79
FR 1772, January 10, 2014). We have determined that an unsafe condition
exists that warrants an interim action until the manufacturer finishes
developing a modification that will address the identified unsafe
condition. Boeing did not formally comment on whether it considers this
issue to be an unsafe condition. We have determined that, without the
required interim actions, a significant number of flights with a fuel
shutoff valve actuator that is failed latently in the open valve
position will occur during the affected fleet life. With a failed fuel
shutoff valve, if certain engine fire conditions were to occur, or if
extreme engine damage were to occur, or if an engine separation event
were to occur during flight, the crew procedures for such an event
would not stop the fuel flow to the engine strut and nacelle. The
continued flow of fuel could cause an uncontrolled fire or lead to a
fuel exhaustion event.
    The FAA regulations require all transport airplanes to be fail safe
with respect to engine fire events, and the risk due to severe engine
damage events be minimized. Therefore, we require, for each flight,
sufficiently operative fire safety systems so that fires can be
detected and contained, and fuel to the engine strut and nacelle can be
shut off in the event of an engine fire or severe damage.
    The FAA airworthiness standards require remotely controlled
powerplant valves to provide indications that the valves are in the
commanded position. These indications allow the prompt detection and
correction of valve failures. We do not allow dispatch with a known
inoperative fuel shutoff valve. Therefore, we are proceeding with the
final rule--not because of the higher-than-typical failure rate of the
particular valve actuator involved, but instead because the fuel
shutoff valve actuator can fail in a manner that also defeats the
required valve position indication feature. That failure can lead to a
large number of flights occurring on an airplane with a fuel shutoff
valve actuator failed in the open position without the operator being
aware of the failure. An airworthiness limitation containing required
inspections is intended to limit the number of flights following latent
failure of the fuel shutoff valve. Issuance of an AD is the appropriate
method to correct the unsafe condition. We have not changed this AD in
this regard.

Request To Provide Further Clarification of the Purpose of the NPRM (79
FR 1772, January 10, 2014)

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, requested that we
revise the NPRM (79 FR 1772, January 10, 2014) to add more details on
the frequency of valve failure findings, and the associated root cause
driving the proposed weekly inspection interval versus the existing
maintenance planning data (MPD) document check interval of 18,000
flight hours.
    We agree with EASA's request to provide further clarification. As
we mentioned in a previous comment response, the reason for this final
rule is not simply a high fuel shutoff valve failure rate, but is
rather a design error that allows a single failure within a fuel
shutoff valve to affect both the control

of the valve and the indication of the valve's position.
    The 18,000-hour check in the MPD document was recommended based on
the assumption that the indication of the fuel shutoff valve position
would not be affected by failures that affect the control of the valve.
With the intended design, there was not a potential for a significant
number of flights to occur with a fuel shutoff valve failed open (even
if the valve was never checked), because the indication system was to
provide real-time indication of the valve's response to commands.
    With the design error that exists in the affected fuel shutoff
valve actuators, indication and control of the valve are not
independent, and if no action is taken, we anticipate a significant
number of flights to occur with a fuel shutoff valve failed open.
Without the issuance of this final rule, our risk assessment and the
manufacturer's risk assessment predict that thousands of flights of
Model 777 airplanes would be conducted with latent fuel shutoff valve
failures.
    In addition to the design error described previously, the affected
fuel shutoff valves have a higher-than-typical rate of failure in
several failure modes. We have received several reports of valves
failed open (discovered only when fuel filters were changed), of valves
failed closed (preventing engine start), and of valves that
spontaneously closed in flight (causing an engine shutdown). Boeing's
long-term solution to provide a redesigned MOV actuator is intended to
address these issues in addition to restoring the independence of the
actuator control and indication features. We have not changed this
final rule in this regard.

Request To Postpone the NPRM (79 FR 1772, January 10, 2014)

    Singapore Airlines (SIA) requested that the FAA consider delaying
the release of the final rule until after the Boeing service
information is issued and sufficient model kits are made available. SIA
also requested that Boeing provide warranty coverage for the post-
modified part replacement and warranty coverage for the man-hours
incurred.
    We disagree with the commenter's request to postpone releasing the
final rule. Because this unsafe condition could exist or develop on
Model 777 airplanes, an airworthiness limitation containing repetitive
inspections as an interim action is necessary to ensure the safety of
the fleet. Issuance of an AD is the appropriate method to correct the
unsafe condition.
    In addition, the manufacturer does not expect a large number of
latently failed valve actuators to be discovered. Existing parts stores
are expected to be sufficient, and parts can be repositioned in time to
support the initial inspections. A functioning fuel shutoff valve is
required at dispatch. This position is consistent with the original
determination in developing the master minimum equipment list (MMEL)
that dispatch relief is not allowed for fire-safety-related flammable
fluid shutoff valves (other than in a locked, closed position for non-
required equipment). However, under the provisions of paragraph (i)(1)
of this AD, we might consider requests for an adjustment to the
compliance time if data are submitted to substantiate that such an
adjustment would provide an acceptable level of safety. In regard to
providing warranty coverage, we cannot comment on Boeing's behalf on
this issue. We have not changed the final rule in this regard.

Request for Clarification of Other Affected Airplane Models

    EASA requested clarification on whether similar designs on other
airplanes could exist. EASA stated that this would be the basis for a
design review of parts of similar design.
    We agree to provide clarification for the commenter. This AD is
applicable to certain Model 777 series airplanes only. Similar AD
action is planned for Model 737NG, 757, 767, and 787 series airplanes.
At this time, our understanding is that no other manufacturer's
airplanes are affected by this specific design problem. We have not
changed the final rule in this regard.

Request To Add Estimated Costs for the Proposed Repetitive Inspections

    AA requested that we revise the NPRM (79 FR 1772, January 10, 2014)
to include the estimated costs for the repetitive inspections of the
MOV actuator of the fuel shutoff valve. AA stated that the cost
included in the NPRM does not account for the cost of the ongoing
inspections. AA stated that the NPRM reflects only the first
inspection. AA also stated that the annual cost of compliance will be
52 times greater, or $839,800, if the inspection is accomplished
weekly. AA stated that these costs should be included for operator
planning purposes.
    We acknowledge the commenter's concern. In this AD, the required
action is to revise the maintenance or inspection program, as
applicable, to include a new airworthiness limitation. The added
airworthiness limitation requires an inspection of the position of the
MOV actuator of the fuel shutoff valve every 10 days. However, these
repetitive inspections, which are expected to take less than an hour to
complete, are required by section 91.403(c) of the Federal Aviation
Regulations (14 CFR 91.403(c)) once incorporated into the maintenance
or inspection program.
    The cost analysis in AD rulemaking actions typically includes only
the costs associated with complying with an AD. In this AD, the
required action is the maintenance or inspection program revision, as
applicable, to include the new airworthiness limitation, and
accomplishing repetitive actions that are specified in the
airworthiness limitation are not directly required by this AD. The FAA,
as a matter of practice, does not include a cost estimate for these
repetitive actions in an AD because these actions are required as part
of the operating rules. Therefore, we have made no change to this final
rule in this regard.

Requests To Limit the Applicability

    Air France, AA, Boeing, and KLM Royal Dutch Airlines (KLM)
requested that the proposed applicability be changed to include only
Model 777 airplanes having line numbers 1 through 1164 inclusive.
    Air France and KLM stated that Boeing Fleet Team Digest 777-FTD-28-
12002, dated January 10, 2014, indicated that airplanes delivered
December 2013 or later incorporate AIMS-2 BlockPoint (BP) v 17, which
has a new function that avoids latently failed fuel shutoff valves.
    Boeing stated that, beginning with line number 1165, all new
production airplanes will be delivered with AIMS-2 BP v 17 or later
software. Boeing also stated that starting with AIMS-2 BP v 17, all
AIMS-2 software versions will include changes to ensure that the
correct fuel shutoff valve position is displayed in the flight deck,
and that the software will monitor both the valve transition and the
end state to ensure the correct position indication.
    Boeing also requested that the proposed applicability be limited to
Model 777 airplanes with part number (P/N) MA20A2027 (S343T003-56) or
P/N MA30A1001 (S343T003-66) actuators installed at the ``engine fuel
spar valve locations.'' Boeing stated that the failure mode exists only
in actuators having these part numbers. Boeing stated that actuators
having P/N MA20A1001-1 (S343T003-39) might be installed in the ``fuel
spar valve location,'' and that actuators having P/N MA20A1001-1
(S343T003-39) are not susceptible to the latent failure addressed by
the NPRM (79 FR 1772, January 10, 2014),

and would not benefit from an interval inspection.
    We agree that the applicability of this AD should be limited. We
have changed paragraph (c) of this AD to include only Model 777
airplanes having line numbers 1 through 1164 inclusive. In addition, in
figure 1 to paragraph (g) of this AD, we have changed the Applicability
column for Airworthiness Limitation (AWL) 28-AWL-MOV to clarify that
the limitation applies to airplanes with the AIMS-1 system having an
actuator with P/N MA20A2027 (S343T003-56) or P/N MA30A1001 (S343T003-
66) installed at the engine fuel spar valve position; and airplanes
with AIMS-2 BP v 16 and earlier software having an actuator with P/N
MA20A2027 (S343T003-56) or P/N MA30A1001 (S343T003-66) installed at the
engine fuel spar valve position.

Request for Clarification of the Proposed Terminating Action

    AA requested clarification of the proposed terminating action. AA
stated the NPRM (79 FR 1772, January 10, 2014) is an interim action,
and no information is provided regarding the terminating action. AA
stated that, if issued, the final rule should contain sufficient
documentation to clearly establish the effectivity of Model 777
airplanes subject to the rule, and to terminate the inspection program
on the subject airplanes. AA stated that Boeing Fleet Team Digest 777-
FTD-28-12002, dated January 10, 2014, among others, addresses the
corrective action plan that is in progress.
    We agree to provide clarification regarding the modification
referenced in the NPRM (79 FR 1772, January 10, 2014). Since the
issuance of the NPRM, the manufacturer has developed a modification
that addresses the unsafe condition identified in this final rule.
However, the service information is not available at this time. Since
we have limited the applicability of this AD to exclude all new
production airplanes that are delivered with AIMS-2 BP v 17 or later
software, as explained previously, we find that no further change to
this AD is necessary in this regard.
    For the affected airplanes, there will likely be two possible
terminating options--one to replace the fuel shutoff valve actuator,
and another to upgrade airplanes with AIMS-2 systems to BP v 17 to
address the unsafe condition. Because service information for these
modifications is still being developed, we have not changed this final
rule in this regard.

Request To Replace the AWL Revision Requirement With MOV Actuator
Inspections Requirement

    Boeing requested that the proposed requirement to incorporate the
MOV actuator inspection into the AWL Section of the Instructions for
Continued Airworthiness of the operator's maintenance or inspection
program be replaced with an AD requirement to ``perform the MOV
inspection every 10 days.'' Boeing stated that the MOV inspection is an
interim mitigation and is required only until a redesigned MOV can be
installed in the spar valve locations. Boeing stated that including the
10-day test requirement as the required AD action would allow
installation of the redesigned MOV to be approved as an alternative
method of compliance (AMOC) to the AD, and as a terminating action for
the repetitive inspections, while avoiding the need for regulatory
approval to remove the AWL from each operator's maintenance or
inspection program. In addition, Boeing stated the AWLs are permanent
actions that affect operators' planning and scheduling, and that
incorporating a temporary AWL into the operators' maintenance documents
or a Boeing MPD document will cause confusion among operators.
    We disagree with the commenter's request. During the development of
the NPRM (79 FR 1772, January 10, 2014), we discussed the impact of an
AWL revision versus a repetitive inspection requirement with Boeing,
who, in turn, discussed it with a sample of operators. At that time,
both Boeing and the operators indicated that the addition of an AWL
revision was the preferred solution because it would reduce the record
keeping required to document AD compliance. Affected operators who wish
to use a repetitive inspection requirement in place of an AWL may apply
for approval of an AMOC in accordance with the provisions specified in
paragraph (i)(1) of this AD, by submitting data substantiating that the
request would provide an acceptable level of safety. We have not
changed this AD in this regard.

Request To Extend the Proposed Compliance Time Grace Period

    AA requested that we extend the grace period for performing the
initial inspection required by the new AWLs. AA stated that it is a
complicated logistical matter to establish a new line maintenance task
at stations throughout the world, and that there is a ``learning curve
to acclimate the line maintenance organizations to the new task.'' In
addition, AA stated that the existing inventory of actuators at
maintenance stations may be insufficient to replace any failed valves
discovered through the inspections, resulting in grounded airplanes,
and that ordering new valves from the vendor generally takes at least
30 days.
    We partially agree with the commenter's request. We retained the
30-day compliance time for revising the maintenance or inspection
program, as applicable, to include the new AWL. In addition, we have
changed the initial compliance time for accomplishing the actions
specified in figure 1 to paragraph (g) of this AD to 10 days. The
compliance time of 10 days is consistent with other regulatory actions
on other affected airplane models.
    We have determined that the initial compliance time for the
inspection represents an appropriate time in which the required actions
can be performed in a timely manner within the affected fleet, while
still maintaining an adequate level of safety. In developing an
appropriate compliance time, we considered the safety implications,
parts availability, and normal maintenance schedules for timely
accomplishment of the checks.
    The check itself involves a visual inspection of an existing
prominent design feature that is intended to indicate the position of
the fuel shutoff valve actuator. This check is also described in
existing maintenance documentation. The manufacturer does not expect a
large number of latently failed valve actuators to be discovered.
Existing parts stores are expected to be sufficient, and we expect that
parts can be repositioned in time to support the initial inspections.
However, under the provisions of paragraph (i) of this AD, we might
consider requests for adjustments to the compliance time if data are
submitted to substantiate that such an adjustment would provide an
acceptable level of safety.

Requests To Extend the Interval for the MOV Actuator Inspection

    Aerologic GmbH, Air France, All Nippon Airways (ANA), AA, Boeing,
FedEx, Japan Airlines Company Ltd. (JAL), KLM Royal Dutch Airlines
(KLM), Lufthansa Technik AG (LTK), and Lufthansa Cargo AG (LUB)
requested that we change the interval for the MOV actuator inspection
of the engine fuel shutoff valve.
    Aerologic GmbH, Air France, Lufthansa LTK, Lufthansa LUB, and KLM
stated that the interval should be 25 flight cycles based on a typical
utilization in flight cycles that corresponds to a one-week interval.
The operators stated that the actuator failure

mode is associated with the cycling of the valve, and the interval
should, therefore, be based on flight cycles.
    AA stated that the ``weekly'' interval is not defined sufficiently,
and that it is not clear whether this means once every seven days, one
time each calendar week, or some other interpretation. AA stated that,
for its airline and for many other international carriers, this
presents a problem when the airplane continually crosses the
International Date Line. AA also stated that the interval does not
address occurrences where the airplane is out of service for an
extended period of time, such as a week or longer. AA stated that it
has strong concerns that the proposed interval may impede the airline's
ability to function on its current published schedule. AA stated that
many established flight routings occur on a four-day cycle, and not all
stations can be set up to perform the inspection for logistical,
personnel, and contractual reasons; therefore, the weekly interval
makes it very difficult to achieve the inspection at available
stations. AA stated that the inspection, if mandated, should be on a
flight-cycle interval rather than a calendar schedule, and suggested a
25-flight-cycle interval to alleviate the ``weekly'' term
interpretation issue, and to address the adverse impact to airline
operations.
    JAL and ANA requested that the inspection interval be ``25 flight
cycles or more, or weekly or more, whichever occurs later.'' JAL stated
that the FAA-proposed inspection interval of ``weekly'' is without
detailed information such as the number of latently failed fuel shutoff
valves, failure rates, and so forth. JAL stated that it understands
that it is preferable to control inspection intervals in flight cycles
for international flights. JAL and ANA also stated that an average
flight cycle for a Model 777 airplane might be 2.5 flight cycles per
day, but that their domestic Model 777 flight cycle average is 6 flight
cycles per day; therefore, it is a burden to inspect the MOV actuators
at per-flight-cycle-related intervals. ANA stated that it prefers a
compliance time of 18,000 flight cycles, which is stated in the MPD
document. ANA stated that they currently perform the proposed
inspection at 2,000-flight-hour intervals, and while it has experienced
several fuel valve actuator failures, it has not detected any latently
failed open fuel valve actuators.
    SIA requested that the proposed inspection interval be extended to
2,000 flight hours. SIA stated that the inspections are disruptive,
laborious, and costly to operations, and would require SIA to inspect
at least three to four airplanes daily. SIA also stated that frequent
opening and closing of panels to inspect the MOV actuator may
inadvertently disrupt other airplane systems and result in unintended
defects. SIA stated that, if operators are unable to inspect the
airplane within the mandated intervals, or if the inspection findings
require extensive rectification, Boeing or the FAA should consider
granting operators a ``no technical objection'' or an AMOC to allow the
airplane to be released to service for a restricted period of time. SIA
also stated that it understands Boeing is working on a modified MOV
actuator part number that would resolve the reliability issue
associated with it.
    Boeing requested that the interval be changed to 10 days. Boeing
stated that it understood the term ``weekly'' to mean 10 days.
    We partially agree with the commenters' request. We agree with
extending the inspection interval to 10 days. Some operators' route
structures and maintenance intervals do not align with a 7-day
interval. Also, several of the operators routinely cross the
International Date Line, potentially creating confusion over the
application of an interval when expressed as ``weekly.'' The 10-day
interval will provide more operational flexibility and will not
significantly increase the number of at-risk flights. We have changed
paragraph (g) of this AD and figure 1 to paragraph (g) of this AD
accordingly.
    We also added a note to the Interval column of figure 1 to
paragraph (g) of this AD to specify that the inspection is not required
on days when the airplane is not used in revenue service, and that the
inspection must be done before further flight if it has been 10 or more
calendar days since the last inspection.
    However, we disagree with changing the interval basis to flight
cycles. While the failure of the fuel shutoff valve is likely
associated with the cycling of the valve, the purpose of the
inspections is to minimize the exposure to flights that are initiated
with a valve actuator that is latently failed in the open position.
    To determine the appropriate actions and intervals to minimize this
exposure, we considered the actions necessary to detect the latent
failure on each affected airplane model, and then, based on those
identified actions, determined a minimum practical interval for
performing the actions.
    On other Boeing airplane models with designs that allow a check to
be performed using available indications, we determined that a daily
check is appropriate. That interval is similar to the check interval
required for fire detection systems. For the affected Model 777
airplanes identified in this final rule, the fuel shutoff valve
position cannot be checked using available indications, and a physical
inspection of the valve actuator itself is necessary to detect the
latent failure. Because of the work necessary to perform this
inspection, we determined that a daily interval would be overly
burdensome and that the 10-day interval would be a more appropriate
balance of the risk and the burden of performing the inspection.
However, affected operators may apply for approval of an AMOC in
accordance with the procedures specified in paragraph (i)(1) of this AD
by submitting data substantiating that the request would provide an
acceptable level of safety.
    We also disagree that the performance of these inspections is
likely to cause defects in other systems. While additional defects due
to unrelated causes might be discovered during the visual inspection,
the opening of the access door and visual inspection of the fuel
shutoff valve position is not expected to cause other system failures.

Request To Allow Use of Parts From Less Critical Locations

    FedEx requested that a provision be added to the proposed AD (79 FR
1772, January 10, 2014) to allow the removal of a working MOV actuator
from a less critical fuel system valve location and installation in the
engine fuel shutoff valve. FedEx stated that this will reduce the
immediate impact of any actuator failures discovered by the required
inspection.
    We disagree with the request. This situation is not unique to the
MOV actuator of the fuel shutoff valve. It is not our intent in this AD
to change operational practices used in performing maintenance and
alterations, or to change relief provided by the minimum equipment list
(MEL). The removal of a fully functional part from a less critical
location and its replacement with a non-functioning part is considered
an alteration and, as such, must meet the airworthiness regulations,
which is not possible in this case. However, if a failure occurs at a
less critical location, operation in the same exact configuration may
be allowed for a limited time under the MEL. The decision to allow this
type of maintenance action remains with the local Flight Standards
organization. Also, it should be noted that the installation of certain
MOV actuators is prohibited by FAA AD 2013-05-03, Amendment 39-17375
(78 FR 17290, March 21, 2013). We have not changed this AD in this
regard.

Additional Change Made to This AD

    In the ``Description'' column of figure 1 to paragraph (g) of this
AD, we have removed the phrase ``refer to Boeing AMM 28-22-00'' for
performing an inspection of the MOV actuator of the fuel spar valve
(i.e., the fuel shutoff valve).

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously, and minor editorial
changes. We have determined that these minor changes:
     [Agr]re consistent with the intent that was proposed in
the NPRM (79 FR 1772, January 10, 2014) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 1772, January 10, 2014).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Interim Action

    We consider this AD interim action. The manufacturer has developed
a modification that addresses the unsafe condition for some of the
airplanes identified in this AD. Once the service information for the
modification is developed, approved, and available, we might consider
additional rulemaking.

Costs of Compliance

    We estimate that this AD affects 190 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on  U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Incorporating Airworthiness           1 work-hour x $85 per                $0              $85          $16,150
 Limitation.                           hour = $85.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under 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.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2015-19-01 The Boeing Company: Amendment 39-18264; Docket No. FAA-
2013-1071; Directorate Identifier 2013-NM-204-AD.

(a) Effective Date

    This AD is effective October 21, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 777-200, -200LR, -
300, -300ER, and 777F series airplanes, certificated in any
category, line numbers 1 through 1164 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Unsafe Condition

    This AD was prompted by reports of latently failed fuel shutoff
valves discovered during fuel filter replacement. We are issuing
this AD to detect and correct latent failures of the fuel shutoff
valve to the engine, which could result in the inability to shut off
fuel to the engine and, in case of certain engine fires, an
uncontrollable fire that could lead to wing failure.

(f) Compliance

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

(g) Revision of Maintenance or Inspection Program

    Within 30 days after the effective date of this AD, revise the
maintenance or inspection program, as applicable, to add
Airworthiness Limitation (AWL) 28-AWL-MOV by incorporating the
information specified in figure 1 to paragraph (g) of this AD into
the Airworthiness Limitations Section of the Instructions for
Continued Airworthiness. The initial compliance time for
accomplishing the actions specified in figure 1 to paragraph (g) of
this AD is within 10 days after accomplishing the maintenance or
inspection program revision required by this paragraph.

  Figure 1 to Paragraph (g) of This AD--AWL for Engine Fuel Shutoff Valve (Fuel Spar Valve) Actuator Inspection
----------------------------------------------------------------------------------------------------------------
           AWL No.                 Task            Interval           Applicability            Description
----------------------------------------------------------------------------------------------------------------
28-AWL-MOV..................  ALI            10 days.............  Airplanes with AIMS- Engine Fuel Shutoff
                                             INTERVAL NOTE: Not     1 system.            Valve (Fuel Spar Valve)
                                              required on days     Airplanes with AIMS-  MOV Actuator
                                              when the airplane     2 BlockPoint (BP)    Inspection.
                                              is not used in        v 16 and earlier    Concern: The fuel spar
                                              revenue service..     software..           valve actuator design
                                             Must be done before   APPLICABILITY NOTE:   can result in airplanes
                                              further flight if     Only applies to      operating with a failed
                                              it has been 10 or     airplanes with a     fuel spar valve
                                              more calendar days    fuel spar valve      actuator that is not
                                              since last            actuator having      reported. A latently
                                              inspection..          part number          failed fuel spar valve
                                                                    MA20A2027            actuator would prevent
                                                                    (S343T003-56) or     fuel shutoff to an
                                                                    MA30A1001            engine. In the event of
                                                                    (S343T003-66)        certain engine fires,
                                                                    installed at the     the potential exists
                                                                    engine fuel spar     for an engine fire to
                                                                    valve position..     be uncontrollable.
                                                                                Perform an inspection of
                                                                                the fuel spar valve
                                                                                actuator.
                                                                                NOTE: The fuel spar
                                                                                valve actuator is
                                                                                located behind latch
                                                                                panel 551 DB (left
                                                                                engine) and latch panel
                                                                                651 DB (right engine).
                                                                                1. Make sure both Engine
                                                                                Control Switches are in
                                                                                the CUTOFF position.
                                                                                NOTE: It is not
                                                                                necessary to cycle the
                                                                                FUEL CONTROL switch to
                                                                                do this inspection.
                                                                                2. Inspect the left
                                                                                engine fuel spar valve
                                                                                actuator located in the
                                                                                left rear spar.
                                                                                a. Verify the manual
                                                                                override handle on the
                                                                                left engine fuel spar
                                                                                valve actuator is in
                                                                                the CLOSED position.
                                                                                b. Repair or replace any
                                                                                fuel spar valve
                                                                                actuator that is not in
                                                                                the CLOSED position
                                                                                (refer to Boeing
                                                                                Airplane Maintenance
                                                                                Manual, 28-22-02, for
                                                                                guidance).
                                                                                3. Inspect the right
                                                                                engine fuel spar valve
                                                                                actuator located in the
                                                                                right rear spar.
                                                                                a. Verify the manual
                                                                                override handle on the
                                                                                right engine fuel spar
                                                                                valve actuator is in
                                                                                the CLOSED position.
                                                                                b. Repair or replace any
                                                                                fuel spar valve
                                                                                actuator that is not in
                                                                                the CLOSED position
                                                                                (refer to Boeing
                                                                                Airplane Maintenance
                                                                                Manual, 28-22-02, for
                                                                                guidance).
----------------------------------------------------------------------------------------------------------------

(h) No Alternative Actions or Intervals

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

(j) Related Information

    For more information about this AD, contact Rebel Nichols,
Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA
98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    None.

    Issued in Renton, Washington, on September 7, 2015.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-23121 Filed 9-15-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 23 (Wednesday, February 4, 2015)]
[Rules and Regulations]
[Pages 5952-5957]
[FR Doc No: 2015-02072]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0514; FRL-9920-44]

Poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, (C10-C16) -alkyl ethers, disodium salts; Exemption
From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of poly(oxy-1,2-ethanediyl), [alpha]-(3-
carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16) alkyl ethers, disodium salts when used as an inert
ingredient (surfactant) in pesticide formulations applied to growing
crops (seed treatment use only) under 40 CFR 180.920 at a concentration
not to exceed 0.125% by weight. BASF submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the
establishment of an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, (C10-C16) alkyl
ethers, disodium salts.

DATES: This regulation is effective February 4, 2015. Objections and
requests for hearings must be received on or before April 6, 2015, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0514, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government 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-2014-0514 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
April 6, 2015. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be

disclosed publicly by EPA without prior notice. Submit the non-CBI copy
of your objection or hearing request, identified by docket ID number
EPA-HQ-OPP-2014-0514, by one of the following methods:
     Federal eRulemaking Portal:
http:[sol][sol]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:[sol][sol]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:[sol][sol]www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of September 5, 2014 (79 FR 53009) (FRL-
9914-98), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10671) by BASF, 26 Davis Dr., Research Triangle Park, NC 27709. The
petition requested that 40 CFR 180.920 be amended by establishing an
exemption from the requirement of a tolerance for residues of poly(oxy-
1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
(C10-C12) alkyl ethers, disodium salts,
polyethoxylation content averages 4-5 moles, Chemical Abstracts Service
Registry Number (CAS Reg. No.) 68954-91-6 and poly(oxy-1,2-ethanediyl),
[alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts, polyethoxylation content
averages 5 moles (CAS Reg. No. 68815-56-5), when used as an inert
ingredient (surfactant) in pesticide formulations applied to growing
crops (seed treatment use only) at a concentration not to exceed 0.125%
by weight under 40 CFR 180.920. That document referenced a summary of
the petition prepared by Exponent on behalf of BASF, the petitioner,
which is available in the docket, http:[sol][sol]www.regulations.gov.
Comments were received on the notice of filing. EPA's response to these
comments is discussed in Unit V.C.

III. Inert Ingredient Definition

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

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for poly(oxy-1,2-ethanediyl),
[alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
(C10-C16)-alkyl ethers, disodium salts follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by poly(oxy-1,2-ethanediyl), [alpha]-(3-
carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this
unit.
    Poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, (C10-C16)-alkyl ethers,
disodium salts include CAS Reg. No. 68815-56-5, which consists of a
C10-C16 linear carbon chain and average
polyethoxylation (POE) = 4.5 and CAS Reg. No. 68954-91-6, which
consists of a C10-C12 linear alkyl carbon chain
and average polyethoxylation (POE) = 5. Although data are not available
for CAS Reg. No. 68954-91-6, EPA relied on available subchronic
toxicity studies on CAS Reg. No. 68815-56-5. These studies are
sufficient to assess the subchronic toxicity of CAS Reg. No. 68954-91-6
as the only difference between the compounds is the range of carbon
chain lengths and the testing of the broader carbon chain length of
C10-C16 in CAS Reg. No. 68815-56-5 would include
any effects that might be seen in tests of the narrower linear carbon
chain

length of C10-C12 (in CAS Reg. No. 68954-91-6).
Reproduction and developmental toxicity studies were not available for
review for either compound, so reproduction data for C12AE6 (CAS Reg.
No. 9002-92-0), which is similar to poly(oxy-1,2-ethanediyl), [alpha]-
(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts in carbon chain length and
average ethoxylation, were used as surrogate data for potential
reproductive effects of CAS Reg. Nos. 68815-56-5 and 68954-91-6. Based
on analogy to well-known metabolic pathways for other linear alkyl
ethers, the major pathway in the primary metabolism of both compounds
is expected to be oxidative-reductive ether cleavage. Therefore, the
metabolism of poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, (C10-C16)-alkyl
ethers, disodium salts would result in the formation of the
corresponding alkyl alcohol alkoxylate such as C12AE6 (CAS Reg. No.
9002-92-0).
    The acute oral and dermal toxicity of poly(oxy-1,2-ethanediyl),
[alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts is low (toxicity category
IV). The Lethal Dose (LD)50 is >5,000 milligram/kilogram
(mg/kg) in the rat (oral) and rabbit (dermal). They are irritating to
the eyes and non-irritating to the skin in rabbits. They are not dermal
sensitizers. Acute inhalation toxicity studies were not available.
    Subchronic toxicity studies were available in the rat and dog for
CAS Reg No. 68815-56-5. CAS Reg No. 68815-56-5 was administered via the
diet in both studies. In a 90-day oral toxicity study in rats,
decreased body weight gain was observed at 4% (equivalent to 2,000 mg/
kg/day (LOAEL)) of CAS Reg No. 68815-56-5. The NOAEL was 1% (equivalent
to 500 mg/kg/day). In a 90-day toxicity study in dogs, toxicity was not
observed at 500 mg/kg/day (NOAEL), the highest dose tested.
    An acceptable developmental toxicity study is not available;
however, in a 2-generation reproduction study in rats on C12AE6,
decreased body weight gain was observed in parental animals at 0.5%
(equivalent to 250 mg/kg/day). The NOAEL was 0.1% (equivalent to 50 mg/
kg/day). Offspring toxicity was manifested as decreased weight gain in
pups, increased embryo lethality and soft tissue anomalies at 0.5%
(equivalent to 250 mg/kg/day). The NOAEL was 0.1% (equivalent to 50 mg/
kg/day). Although fetal qualitative susceptibility is observed in this
study, the concern is low because effects occurred only in the presence
of maternal toxicity.
    Chronic/carcinogenicity studies with poly(oxy-1,2-ethanediyl),
[alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, alkyl ethers,
disodium salts were not available. However, a DEREK structural alert
analysis was conducted with poly(oxy-1,2-ethanediyl), [alpha]-(3-
carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C12)-alkyl ethers, disodium salt (CAS Reg No. 68954-91-6)
and indicated no structural alerts for carcinogenicity or mutagenicity.
Therefore, poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, alkyl ethers, disodium salts are not
expected to be carcinogenic.
    Mutagenicity studies were not available for poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
(C10-C16)-alkyl ethers, disodium salts. However,
an Ames test is available on CAS Reg. No. 68439-50-9, a surrogate alkyl
alcohol alkoxylate. The test was negative.
    Neurotoxicity studies were not available for review. Although
ataxia was observed in the dams in the developmental toxicity study in
rabbits at 100 mg/kg/day, the onset and persistence of ataxia were not
reported and thus could not be evaluated. Since evidence of ataxia or
other signs of potential neurotoxicity were not observed in the
subchronic studies conducted with rats or dogs at doses >=500 mg/kg/
day, it was concluded that the ataxia observed in the dams was not
likely a result of neurotoxicity.
    Immunotoxicity studies were not available for review. However,
evidence of immunotoxicity was not observed in the submitted studies.
    Metabolism studies on poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-
1-oxosulfopropyl)-[omega]-hydroxy-, (C10-C16)-
alkyl ethers, disodium salts were not available for review. However,
based on analogy to known metabolic pathways for linear alkyl ethers,
the major pathway in the primary metabolism is expected to be
oxidative-reductive ether cleavage. Therefore, the primary metabolism
of poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, alkyl ethers, disodium salts occurs via oxidative-
reductive ether hydrolysis resulting in the formation of linear alkyl
alcohols and polyethylene glycol metabolites. The alcohols would
undergo oxidation by alcohol dehydrogenase and aldehyde dehydrogenase
to generate a fatty acid metabolite that is degraded by [beta]-
oxidation to carbon dioxide (CO2) and water
(H2O). The polyethylene glycol metabolites would be degraded
via oxidation by alcohol dehydrogenase and aldehyde dehydrogenase to
generate a dienoic polyethylene ether acid that may be conjugated and
excreted. Also, the alcohol function may be sulfated by
sulfotransferases and excreted.

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 the NOAEL and the LOAEL are identified.
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.
    An acute effect was not found in the database therefore an acute
dietary assessment is not necessary. The 2-generation reproduction
study in the rat was selected for the chronic exposure for this risk
assessment. The NOAEL in this study was 50 mg/kg/day. The LOAEL was 250
mg/kg/day based on decreased weight gain. This study represents the
lowest NOAEL in the database in the most sensitive species. The dermal
and inhalation absorption rates were assumed to be 100%. The standard
inter- and intra-species uncertainty factors were applied. The Food
Quality Protection Act Safety Factor (FQPA SF) of tenfold (10X) was
retained for the lack of a developmental toxicity study.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, (C10-C16)-alkyl
ethers, disodium salts, EPA considered exposure under the proposed
exemption

from the requirement of a tolerance. EPA assessed dietary exposures
from poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, (C10-C16)-alkyl ethers,
disodium salts in food as follows:
    Dietary exposure (food and drinking water) to poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
(C10-C16)-alkyl ethers, disodium salts can occur
following ingestion of foods with residues from seed-treated crops.
Because no adverse effects attributable to a single exposure of
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, (C10-C16)-alkyl ethers, disodium salts
were seen in the toxicity databases, an acute dietary risk assessment
is not necessary. For the chronic dietary risk assessment, EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCIDTM), Version 3.16, and food
consumption information from the U.S. Department of Agriculture's
(USDA's) 2003-2008 National Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA). One hundred percent crop treated
was assumed, default processing factors, and tolerance-level residues
for all foods and use limitations of not more than 0.125% by weight in
pesticide formulations.
    2. Cancer. A DEREK structural alert analysis indicated no
structural alerts for carcinogenicity or mutagenicity. Therefore,
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, (C10-C16)-alkyl ethers, disodium salts
are not expected to be carcinogenic and a cancer risk assessment is
unnecessary.
    3. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
(C10-C16)-alkyl ethers, disodium salts, a
conservative drinking water concentration value of 100 parts per
billion (ppb) based on screening level modeling was used to assess the
contribution to drinking water for the chronic dietary risk assessments
for parent compound. These values were directly entered into the
dietary exposure model.
    4. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, and tables).
    Poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, (C10-C16)-alkyl ethers,
disodium salts are not expected to result in residential exposure based
on its use pattern as a seed treatment for agricultural crops.
    5. 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 poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, alkyl ethers, disodium salts to share
a common mechanism of toxicity with any other substances, and poly(oxy-
1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
alkyl ethers, disodium salts does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
alkyl ethers, disodium salts 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 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 SF. In applying this
provision, EPA either retains the default value of 10X, or uses a
different additional safety factor when reliable data available to EPA
support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The toxicity database for
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, alkyl ethers, disodium salts contains two subchronic studies,
a reproductive toxicity study, a developmental toxicity study and
mutagenicity studies. Qualitative fetal susceptibility was observed in
the 2-generation toxicity study in rats. However, concern for fetal
effects are low since they only occurred in the presence of maternal
toxicity and protecting against maternal toxicity will subsequently
prevent fetal toxicity. In addition, the chronic reference dose (cRfD)
was based on this study and will be protective of fetal effects.
However, since the developmental study in rabbits was unacceptable, the
FQPA SF of 10X was retained to account for an incomplete database.

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,
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, (C10-C16)-alkyl ethers, disodium salts
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
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, alkyl ethers, disodium salts from food and water will utilize
16.2% of the cPAD for non-nursing infants, the population group
receiving the greatest exposure. There are no residential uses for
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, (C10-C16)-alkyl ethers, disodium salts.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Since
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, (C10-C16)-alkyl ethers, disodium salts
have no uses that would result in short-term residential exposure, the
Agency has determined that it is appropriate to

aggregate chronic exposure through food and water only.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Since poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, (C10-C16)-alkyl
ethers, disodium salts have no uses that would result in intermediate-
term residential exposure, the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water only.
    5. Aggregate cancer risk for U.S. population. Based on a DEREK
structural alert analysis and the lack of mutagenicity, poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
(C10-C16)-alkyl ethers, disodium salts are
considered not likely to be carcinogenic.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, (C10-C16)-alkyl
ethers, disodium salts residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. Response to Comments

    A comment was received from a private citizen who was concerned
about the reaction of fatty acid esters to any future chemicals added
to the environment. The Agency understands the commenter's concerns and
recognizes that some individuals believe that no residue of pesticides
should be allowed because of potential interactions with other
chemicals. However, under the existing legal framework provided by
FFDCA section 408, EPA is authorized to establish pesticide tolerances
or exemptions where persons seeking such tolerances or exemptions have
demonstrated that the pesticide meets the safety standard imposed by
the statute, which EPA has determined here.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for poly(oxy-1,2-ethanediyl), [alpha]-
(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts (CAS Reg. Nos. 68954-91-6
and 68815-56-5) when used as inert ingredients (surfactant) in
pesticide products used for seed treatment only at a concentration not
to exceed 0.125% in the end-use formulation.

VII. Statutory and Executive Order Reviews

    This action establishes exemptions to the requirement for a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemptions in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: January 15, 2015.
Susan Lewis,
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.  180.920, add alphabetically to the table after ``Poly(oxy-
1,2-ethanediyl),[alpha]-isotridecyl-[omega]-methoxy (CAS Reg. No.
345642-79-7)'' the two inert ingredients listed below to read as
follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

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

                              * * * * * * *
Poly(oxy-1,2-ethanediyl),         Not to exceed       Surfactant.
 [alpha]-(3-carboxy-1-             0.125% for seed
 oxosulfopropyl)-[omega]-hydroxy-  treatment use
 , (C10-C12)-alkyl ethers,         only.
 disodium salts, polyoxylene
 content averages 4-5 moles (CAS
 Reg. No. 68815-56-5).
Poly(oxy-1,2-ethanediyl),         Not to exceed       Surfactant
 [alpha]-(3-carboxy-1-             0.125% for seed
 oxosulfopropyl)-[omega]-hydroxy-  treatment use
 , (C10-C16)-alkyl ethers,         only.
 disodium salts, polyoxyethylene
 content averages 5 moles (CAS
 Reg. No. 68954-91-6).

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

[FR Doc. 2015-02072 Filed 2-3-15; 8:45 am]
BILLING CODE 6560-50-P