[Federal Register Volume 83, Number 172 (Wednesday, September 5, 2018)]
[Rules and Regulations]
[Pages 45044-45047]
[FR Doc No: 2018-19119]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-1122; Product Identifier 2012-NE-42-AD; Amendment
39-19385; AD 2018-18-06]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2013-02-04 for
all Rolls-Royce plc (RR) RB211-Trent 970-84, RB211-Trent 970B-84,
RB211-Trent 972-84, RB211-Trent 972B-84, RB211-Trent 977-84, RB211-
Trent 977B-84, and RB211-Trent 980-84 turbofan engines. AD 2013-02-04
required on-wing inspections of low-pressure turbine (LPT) disk seal
fins and interstage seals when post-flight review indicates Engine
Health Monitoring (EHM) vibratory maintenance-alert limits were
exceeded in flight. This AD requires additional criteria for the
inspection of the stage 2, 3, and 4 LPT disk seal fins and interstage
seals and removes the requirement to inspect the stage 5 LPT disk seal
fins and interstage seal. This AD was prompted by a Trent 900 engine
experiencing increased low-pressure rotor vibration while in flight
resulting in an in-flight shutdown (IFSD) and air turnback. We are
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective September 20, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September
20, 2018.
    We must receive any comments on this AD by October 22, 2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this final rule, contact
Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby, England,
DE248BJ; phone: 011-44-1332-242424; fax: 011-44-1332-245418, or email:
http://www.rolls-royce.com/contact/civil_team.jsp. You may view this
service information at the FAA, Engine and Propeller Standards Branch,
1200 District Avenue, Burlington, MA, 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the internet

at http://www.regulations.gov by searching for and locating Docket No.
FAA-2017-1122.

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-2017-
1122; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the mandatory continuing airworthiness information,
the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (phone: 800-647-
5527) is listed above. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kevin M. Clark, Aerospace Engineer,
ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone:
781-238-7088; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued AD 2013-02-04, Amendment 39-17325 (78 FR 6206, January
30, 2013), (``AD 2013-02-04''), for all RR RB211-Trent 970-84, RB211-
Trent 970B-84, RB211-Trent 972-84, RB211-Trent 972B-84, RB211-Trent
977-84, RB211-Trent 977B-84, and RB211-Trent 980-84 turbofan engines.
AD 2013-02-04 required on-wing inspections of LPT disk seal fins and
interstage seals when post-flight review indicates EHM vibratory
maintenance-alert limits were exceeded in flight. AD 2013-02-04 also
required in-shop inspections of the LPT disk seal fins and interstage
seals to detect cracks or damage and, depending on the findings,
accomplishment of corrective action. AD 2013-02-04 resulted from a
Trent 900 engine experiencing LPT stage 2 disk interstage seal material
loss and increased low-pressure rotor (N1) vibration while in flight.
We issued AD 2013-02-04 to prevent cracks in the LPT disk, which could
result in uncontained engine failure and damage to the airplane.

Actions Since AD 2013-02-04 Was Issued

    Since we issued AD 2013-02-04, a Trent 900 engine experienced
increased N1 vibration while in flight resulting in an IFSD and air
turnback. Inspection of the engine revealed LPT damage. A subsequent
review of the potential causes determined that engine overhaul shop
visit activities could be a factor. RR issued Revision 2 to Alert Non-
Modification Service Bulletin (NMSB) RB.211-72-AH054 to introduce an
inspection of the LPT disk seal fins and interstage seals after an
overhaul shop visit when an engine test (pass-off test) is required due
to the work performed. RR also published Revision 3 to Alert NMSB
RB.211-72-AH054, dated February 1, 2018, to remove engines that have
incorporated the modifications introduced by RR Alert SB RB.211-72-
AJ592, dated September 4, 2017, from its applicability. In addition,
the European Aviation Safety Agency (EASA) published AD 2018-0126,
dated June 11, 2018, to require the changes introduced by Revision 3 of
RR Alert NMSB RB.211-72-AH054. We are issuing this AD to address the
unsafe condition on these products.

Related Service Information Under 1 CFR Part 51

    We reviewed RR issued Alert NMSB RB.211-72-AH054, Revision 3, dated
February 1, 2018. The Alert NMSB describes procedures for inspection
after a pass-off test. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by EASA 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 issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

AD Requirements

    This AD partially retains the requirements of AD 2013-02-04,
requires inspection of the LPT disk seal fins and interstage seals
following pass-off test, and changes certain inspection requirements.

FAA's Justification and Determination of the Effective Date

    No domestic operators use this product. Therefore, we find good
cause that notice and opportunity for prior public comment are
unnecessary. In addition, for the reason stated above, we find that
good cause exists for making this amendment effective in less than 30
days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this AD. Send
your comments to an address listed under the ADDRESSES section. Include
the docket number FAA-2017-1122 and product identifier 2012-NE-42-AD at
the beginning of your comments. We specifically invite comments on the
overall regulatory, economic, environmental, and energy aspects of this
AD. We will consider all comments received by the closing date and may
amend this AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD affects 0 engines installed on 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
----------------------------------------------------------------------------------------------------------------
Inspection of LPT disk seal fins and    8 work-hours x $85 per                $0            $680              $0
 interstage seals.                       hour = $680.
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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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

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 part 39 of the Federal Aviation
Regulations (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 removing Airworthiness Directive (AD)
2013-02-04, Amendment 39-17325 (78 FR 6206, January 30, 2013), and
adding the following new AD:

2018-18-06 Rolls-Royce plc: Amendment 39-19385; Docket No. FAA-2017-
1122; Product Identifier 2012-NE-42-AD.

(a) Effective Date

    This AD is effective September 20, 2018.

(b) Affected ADs

    This AD replaces AD 2013-02-04, Amendment 39-17325 (78 FR 6206,
January 30, 2013).

(c) Applicability

    This AD applies to all Rolls-Royce plc (RR) RB211-Trent 970-84,
RB211-Trent 970B-84, RB211-Trent 972-84, RB211-Trent 972B-84, RB211-
Trent 977-84, RB211-Trent 977B-84, and RB211-Trent 980-84 turbofan
engines that have not incorporated the modifications introduced by
RR Alert Service Bulletin RB.211-72-AJ592, dated September 4, 2017.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7350, Turbine
Section.

(e) Unsafe Condition

    This AD was prompted by a Trent 900 engine experiencing
increased low-pressure rotor vibration while in flight resulting in
an in-flight shutdown and air turnback. We are issuing this AD to
prevent cracks in the low-pressure turbine (LPT) disk. The unsafe
condition, if not addressed, could result in uncontained engine
failure and damage to the airplane.

(f) Compliance

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

(g) Required Actions

    (1) After the effective date of this AD, after every flight,
review the Engine Health Monitoring low-pressure rotor (N1)
vibration data within 10 engine flight cycles (FCs).
    (i) If you find that the maximum and average vibrations exceed
0.7 inches/sec (ips) and 0.5 ips, respectively, then within 10
engine FCs:
    (A) Confirm that the vibration data was not the result of
indicator error.
    (B) If you cannot show that the vibration increase was caused by
indicator error, inspect the LPT stage 2, 3, and 4 disk seal fins
and interstage seals in accordance with the Accomplishment
Instructions, paragraph 3.B., of RR Alert Non-Modification Service
Bulletin (NMSB) RB.211-72-AH054, Revision 3, dated February 1, 2018.
    (ii) Reserved.
    (2) After the effective date of this AD, each time a pass-off
test is performed on an engine after induction into a Repair and
Overhaul Shop, inspect the LPT stage 2, 3, and 4 disk seal fins and
interstage seals in accordance with the Accomplishment Instructions,
paragraph 3.C., of RR Alert NMSB RB.211-72-AH054, Revision 3, dated
February 1, 2018.
    (4) If, during the inspections required by paragraph (g) of this
AD, you find any cracks in the disk seal fins or any interstage
seals are missing seal material, replace the parts with parts
eligible for installation before further flight.

(h) Credit for Previous Actions

    You may take credit for the initial inspections required by
paragraph (g)(1) of this AD if, following detection of excessive N1
vibration, you performed the inspections using RR Repeater Technical
Variance (TV) 125658, Issue 2, dated August 14, 2012; or RR Repeater
TV 125060, Issue 1, dated July 27, 2012, or Issue 2, dated January
30, 2013; or RR Alert NMSB RB.211-72-AH054, Initial issue, dated
September 14, 2012; Revision 1, dated November 5, 2012; or Revision
2, dated August 24, 2016.

(i) Definition

    For the purpose of this AD, a ``pass-off test'' is a test on any
engine performed in accordance with Task 72-00-00-760-801, General
Procedures for Engine Testing, from the Rolls-Royce Trent 970-84
Engine Manual, dated December 1, 2016.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, 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
certification office, send it to the attention of the person
identified in paragraph (k)(1) of this AD. You may email your
request to: [email protected].
    (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.

(k) Related Information

    (1) For more information about this AD, contact Kevin M. Clark,
Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA, 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email: [email protected].
    (2) Refer to European Aviation Safety Agency (EASA) AD 2018-
0126, dated June 11, 2018, for more information. You may examine the
EASA AD in the AD docket on the internet at http://www.regulations.gov by

searching for and locating it in Docket No. FAA-2017-1122.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Rolls-Royce plc (RR) Alert Non-Modification Service Bulletin
RB.211-72-AH054, Revision 3, dated February 1, 2018.
    (ii) Reserved.
    (3) For RR service information identified in this AD, contact
Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby,
England, DE248BJ; phone: 011-44-1332-242424; fax: 011-44-1332-
245418, or email: http://www.rolls-royce.com/contact/civil_team.jsp.
    (4) You may view this service information at FAA, Engine and
Propeller Standards Branch, 1200 District Avenue, Burlington, MA,
01803. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on August 27, 2018.
Karen M. Grant,
Acting Manager, Engine and Propeller Standards Branch, Aircraft
Certification Service.
[FR Doc. 2018-19119 Filed 9-4-18; 8:45 am]
 BILLING CODE 4910-13-P


 ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY  Notice of Filing of a Pesticide Petition for the Establishment of Tolerances for  Residues of Chlorantraniliprole in or on Food Commodities AGENCY: Environmental Protection Agency (EPA). ACTION: Notice.  Interregional Research Project Number 4 (IR-4)  Pesticide Petition (PP#) 3E8170  -----------------------------------------------------------------------

 SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of tolerances for residues of chlorantraniliprole in or on food commodities under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

FOR   FURTHER   INFORMATION   CONTACT:   Laura Nollen,<PHONE_NUMBER><EMAIL_ADDRESS>. Registration Division, (7505), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460.

 SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition #3E8170, proposing the establishment and/or amendment of regulations for residues of certain pesticide chemicals in or on onion,  green,  subgroup  3-07B;  fruit, stone, group 12-12, except cherry, chickasaw plum, and damson plum; papaya; passionfruit; nut, tree, group 14-12; and spice, subgroup 19B under section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a (d). EPA has determined that this petition contains data or information regarding the elements set forth in section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition.  Additional data may be needed before EPA rules on the petition.

 List of Subjects

 Environmental  Protection,  Agricultural  Commodities,  Food  Additives,  Feed  Additives, Pesticides and Pests, Reporting and Recordkeeping Requirements. Summary of Petition  A summary of the pesticide petition is given below. The petitioner prepared the summary of the petition.

 PP# 3E8170

 EPA has received a pesticide petition, PP# 3E8170, from the Interregional Research Project Number 4 (IR-4), IR-4 Project Headquarters, 500 College Road East, Suite 201 W, Princeton, New Jersey, 08540, proposing, pursuant to section  408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish tolerances for residues of chlorantraniliprole, 3- bromo-N-[4-chloro-2-methyl-6-[(methylamino)-carbonyl]phenyl]-1-(3-chloro-2- pyridinyl)-1H-pyrazole-5-carboxamide in  or on  onion,  green,  subgroup  3-07B  at  3.0 ppm; fruit, stone, group 12-12, except cherry, chickasaw plum, and damson plum at 4.0 ppm; papaya at 4.0 ppm; passionfruit at 4.0 ppm; nut, tree, group 14-12 at 0.04 ppm; and spice subgroup 19B at 40 ppm. Concurrently, IR-4 is requesting removal of the following existing time-limited tolerances: leek; onion, green; onion, Welsh; and shallots, fresh leaves at 0.2 ppm.IR-4 is finally requesting remove of the following permanent tolerances: fruit, stone, group 12, except cherry, chickasaw plum, and damson plum at 4.0 ppm; mayhaw at 0.6 ppm; papaya and passionfruit at 2.0 ppm; nut, tree, group 14 at 0.04 ppm; pistachio at 0.04 ppm and spice, subgroup 19B at 14 ppm.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition.  Additional data may be needed before EPA rules on the petition.

 A. Residue Chemistry

       1. Plant metabolism.      The metabolism of chlorantraniliprole is adequately understood to support the proposed exemption from the requirement of tolerances. Studies in apple, lettuce, rice, tomato, and cotton when treated at proposed label rates showed no significant metabolites.  The only significant residue is the parent compound.

       2. Livestock Metabolism. The metabolism of chlorantraniliprole in ruminants and poultry is adequately understood to support the exemption from the requirement of tolerances.  Lactating goat and laying hen metabolism studies were conducted. The goat and hen rapidly excreted >93% and >98% of the dosed radiolabeled residues, respectively.

       The metabolic pathway in poultry and ruminant (goat) animals was consistent. There is no reasonable expectation of transfer of finite residues of chlorantraniliprole and its metabolites to fat, meat, milk, and eggs.

       3. Analytical method.  Since chlorantraniliprole and its metabolic degradates are not of toxicological concern, analytical methods are not applicable.

       4. Magnitude of residues. Greenhouse residue trials were conducted with chlorantraniliprole on the raw agricultural commodity cucumbers.   Three MOR trials were conducted. The locations of the field trials were selected to represent the regions with most greenhouse cucumber production. A foliar broadcast spray of chlorantraniliprole was applied at the rate of 0.1 lb ai/A/application. The cucumber plants received two applications targeted at 1 day before harvest (1-day PHI) of mature crop.   Concurrent recoveries from control samples fortified at        0.010 to 5.0 mg/kg of chlorantraniliprole ranged from 96 to 100%.  The maximum residue level in cucumbers was 0.0738 ppm which is below the currently established tolerance of 0.5 ppm for cucurbits.

       Greenhouse residue trials were conducted with chlorantraniliprole on the raw agricultural  commodity  tomatoes.     Four  MOR  trials  were  conducted.  The locations of the field trials were selected to represent the regions with most greenhouse tomato production. A foliar broadcast spray of chlorantraniliprole was applied at the rate of 0.1 lb ai/A/application. The tomato plants received two applications targeted at 1 day before harvest (1-day PHI) of mature crop. Concurrent recoveries from control samples fortified at 0.010 to 5.0 mg/kg of chlorantraniliprole ranged from 98 to 102%.  The maximum residue level in tomatoes was 0.102 ppm which is below the currently established tolerance of 1.4 ppm for fruiting vegetables.

       Field   residue   trials   were   conducted   with   chlorantraniliprole   on   the   raw agricultural commodities cherry, papaya and lychee.   Two MOR trials were conducted for each commodity. A foliar broadcast spray of chlorantraniliprole was applied at the rate of 0.1 lb ai/A/application. The test plants received two applications targeted at 1, 3, 6-7, 9-10 and 13-15 days before harvest of mature crop.  Concurrent recoveries from control samples fortified at 0.010 to 5.0 mg/kg of chlorantraniliprole ranged from 97 to 123%.   In cherry samples, the total residues of chlorantraniliprole ranged from 0.151 to 0.192 ppm in samples taken at 1 day PHI, 0.135 to 0.162 ppm in samples taken at 3 days PHI, 0.105 to 0.120 ppm in samples taken at 6 days PHI, 0.132 to 0.151 ppm in samples taken at 10 days PHI and 0.0994 to 0.129 ppm in samples taken at 15 days PHI. In lychee samples, the total residues of chlorantraniliprole ranged from 0.402 to 0.500 ppm in samples taken at 1 day PHI, 0.306 to 0.442 ppm in samples taken at 3 days PHI, 0.363 to 0.386 ppm in samples taken at 6 days PHI, 0.239 to 0.313 ppm in samples taken at 9 days PHI and 0.308 to 0.337 ppm in samples taken at 13 days PHI. In papaya samples, the total residues of chlorantraniliprole ranged from        0.284 to 0.292 ppm in samples taken at 1 day PHI, 0.204 to 0.224 ppm in samples taken at 3 days PHI, 0.196 to 0.211 ppm in samples taken at 7 days PHI, 0.164 to        0.196 ppm in samples taken at 10 days PHI and 0.137 to 0.142 ppm in samples taken at 14 days PHI.

       Field   residue   trials   were   conducted   with   chlorantraniliprole   on   the   raw agricultural commodities onions and dill.  Five MOR trials were conducted with onions and two MOR trials were conducted with dill. The locations of the field

       trials were selected to represent the regions with most onion and spice production. A foliar broadcast spray of chlorantraniliprole was applied at the rate of 0.1 lb ai/A/application. The onion and dill crops received two applications targeted at 1 day before harvest (1-day PHI) of mature crop.   Concurrent recoveries from control samples fortified at 0.010 to 5.0 mg/kg of chlorantraniliprole ranged from        81 to 117%.  The total residues of chlorantraniliprole ranged from 0.371 to 1.50 ppm in fresh green onion samples taken at 1 day PHI. The total residues of chlorantraniliprole ranged from 0.900 to 11.1 ppm in dried green onion samples taken at 1 day PHI. The total residues of chlorantraniliprole ranged from 15.4 to        24.3 ppm in dill seed samples taken at 1 day PHI.

       Numerous residue studies have been conducted on many crops in the United        States and globally by the registrant and by other organizations such as the IR-4        Project.  The relevant U.S. and foreign residue study reports required to support use of chlorantraniliprole and existing tolerances in the United States have been submitted to EPA and reviewed as part of prior registration actions for this active ingredient.

 B. Toxicological Profile

       1. Acute toxicity. Based on EPA criteria, chlorantraniliprole is classified as follows for Toxicity Categories:

 Guideline  Title  Results  Category  870.1100

 870.1200

 870.1300

 870.2400

 870.2500

 870.2600  Acute Oral Toxicity  Acute Dermal Toxicity Acute Inhalation Toxicity Primary Eye Irritation Primary Dermal Irritation Skin Sensitization  LD50: >5,000 mg/kg (Rat)

 LD50: >5,000 mg/kg (Rat) LC50: >5.1 mg/L (Rat) Mild irritation (Rabbit)  No irritation (Rabbit)

 Not a sensitizer (Mouse LLNA)  Category IV

 Category IV Category IV Category IV Category IV  ---------------

 Formulated products are as equally non-toxic following acute exposures as is technical chlorantraniliprole.  The acute inhalation toxicity for the suspension concentrate formulation could not be determined above the maximum practically attainable atmospheric aerosol concentration of 2 mg/L.

 There was no evidence of neurotoxicity in rats following a single limit dose of 2,000 mg/kg

 2. Genotoxicty. Chlorantraniliprole has shown no genotoxic activity in the following listed in vitro and in vivo tests:

    −	Bacterial reverse mutation     −	In vitro mammalian gene mutation (CHO/HGPRT)     −	In vitro chromosomal aberration (human lymphocytes)     −	In vivo mouse micronucleus

 3. Reproductive and developmental toxicity.   In developmental toxicity studies in rats and rabbits, chlorantraniliprole exhibited no effects on any parameter in pregnant females or their offspring at levels up to and including the maximum tested dose of 1,000 mg/kg bw/day.  No reproductive toxicity was observed in a two-generation reproduction study with chlorantraniliprole in rats.  No adverse effects were observed on reproduction, fertility, sperm parameters, estrous cycle, litter size, pup survival and developmental landmarks up to the maximum tested dose of 20,000 ppm in the diet.  There were no adverse histological findings indicative of reproductive toxicity.  There was a slight reduction in the F1 pup (but not F2 pup) weight during lactation at the highest dose level (mean maternal intake during lactation equal to 3,118 mg/kg bw/day); this was attributed, in part, to weight loss in one dehydrated dam during lactation which had a litter with some of the lowest pup weights. The slight change in pup weight was without subsequent effects since overall body weight, weight gain and development in F1 rats fed 20,000 ppm were similar to control animals.

       4. Subchronic toxicity.  Subchronic (90-day) feeding studies were conducted with rats, mice and dogs. No adverse effects were observed at the highest dietary concentrations tested of 20,000 ppm in rats (1,188 mg/kg bw/day for males and 1,526 mg/kg bw/day for females), 7,000 ppm in mice (1,135 mg/kg bw/day for males and 1,539 mg/kg bw/day for females) and 40,000 ppm in dogs (1,163 mg/kg bw/day for males and 1,220 mg/kg bw/day for females). Chlorantraniloprole showed no evidence of immunotoxicity in 28-day feeding studies in rats or mice and no evidence of neurotoxicity in a 90-day feeding study in rats at dietary concentrations greater than the limit dose of 1,000 mg/kg bw/day.

 A 28-day dermal toxicity study in rats was conducted at doses of 100, 300 and 1,000 mg/kg bw/day.  The NOAEL for male and female rats was 300 mg/kg bw/day based on reductions in body weight gain and food efficiency at 1,000 mg/kg bw/day.

       No adverse target organ effects were observed in any subchronic toxicity study.

       5. Chronic toxicity.  Chlorantraniliprole was not carcinogenic in either a 2-year study in rats or an 18- month study in mice.  The NOAEL for chronic toxicity in the 18-month mouse study was  1,200 ppm (158 mg/kg bw/day in males) and was based on eosinophilic foci accompanied by hepatocellular hypertrophy and increased liver weight.  In rats, there were no adverse effects on any in-life parameter in either males or females administered chlorantraniliprole up to and including a maximum dietary concentration of 20,000 ppm for 2 years (805 and 1,076 mg/kg bw/day, respectively).

       In a one-year feeding study in dogs, the NOAEL was the highest dose tested, 40,000

 ppm (1,164 and 1,233 mg/kg/day in males and females, respectively).

       6. Rat metabolism.  The absorption of [14C]-chlorantraniliprole in rats was rapid with peak concentrations occurring at 5-12 hours after single dose administration. Tissue distribution of the absorbed dose was extensive and indicated low potential for accumulation.   Excretion was substantially complete by 48-72 hours after dosing (>90%).

 Following 14 days of oral administration 14C residues were readily eliminated from the plasma and tissues and confirmed minimal potential for accumulation. The profile of metabolites in urine and feces indicated extensive metabolism consistent with that observed for the single dose study.

 7. Metabolite toxicology. Due to the extremely low toxicity of the parent compound and the extensive metabolism observed in mammalian systems, chlorantraniliprole metabolites are not expected to result in any significant toxicity.   Toxicology studies conducted with metabolites support this conclusion.

 8. Endocrine disruption.  No adverse effects were observed on any endocrine tissue in short- and long-term studies in rats, mice and dogs.

 C. Aggregate Exposure  1. Dietary exposure -- i. Food.  Because an endpoint attributable to a single dose was not identified, the dietary exposure assessment considered only chronic exposure.

 Chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model (DEEM-FCID(TM), Version 2.03) which uses food consumption data from the U.S. Department of Agriculture's Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. The chronic dietary exposure assessment was  conducted  using  a  chronic  reference  dose  of  1.58  mg/kg  bw/day  based  on  the NOAEL established in the 18-month study in mice.  DuPont has conducted chronic assessments which assume that 100% of all crops  -  including those not labeled - are treated with chlorantraniliprole and that all crops contain residues at tolerance level or at residue  levels  equal  to  tolerance  levels  for  similar  crops.    In  particular  all  leafy vegetables, including leaves of root and tuber vegetables and leafy vegetables including brassica vegetables, are assumed to have residues of 15 parts per million.   All other human foods (including plant and animal commodities) are assumed to have residues of 2 parts per million.

 These assumptions result in conservative, health-protective estimates of exposure which are well below the Agency's level of concern (100% of the cPAD). The maximum estimate is less than 11% of the cPAD for all population subgroups.

 ii.  Drinking  water.     A  drinking  water  assessment  for  chlorantraniliprole, conducted based on PRZM/EXAMS (Pesticide Root Zone Model/Exposure Analysis Modeling System), was used to calculate the surface water estimated drinking water

 concentrations (EDWCs) and the Screening Concentration in Ground Water (SCI- GROW) model was used to calculate the groundwater EDWC. The EDWCs do not exceed the Agency's level of concern.

 2. Non-dietary exposure.  Residential exposure (non-occupational, non-dietary exposure  to  consumers)  was  conservatively  assessed  for  dermal  post-application exposure (children and adults), and for children the oral exposures via hand-to-mouth, object-to-mouth, and incidental ingestion of soil were also assessed.  The margins of exposure (MOE) greatly exceed the 100-fold MOE required for these routes and from the combined  children's  incidental  oral  ingestion.     Therefore,  residential  non-dietary exposure is not a concern.

 D. Cumulative Effects

 It is not necessary at this time to consider cumulative effects because there is no indication that toxic effects of chlorantraniliprole have a common mechanism with those of any other chemical compounds.

 E. Safety Determination

 1. U.S. population. Based on risk assessments performed using worst-case exposure assumptions there is a reasonable certainty that no harm will result to the general population from the aggregate exposure to chlorantraniliprole.  No additional safety factors are warranted.

 2. Infants and children. Based on the risk assessments performed using worst-case exposure assumptions there is a reasonable certainty that no harm will result to the infants and children from the aggregate exposure to chlorantraniliprole.  No additional safety factors are warranted.

 F. International Tolerances

 Numerous chlorantraniliprole MRLs have been established or are expected to be established supporting registrations in 92 countries.   Codex MRLs have also been established for chlorantraniliprole on numerous crops.


[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Notices]
[Pages 79085-79086]
[FR Doc No: 2016-26559]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0359]

Agency Information Collection Activities; Revision and Extension
of a Currently-Approved Information Collection Request: Hazardous
Materials Safety Permits

AGENCY: Federal Motor Carrier Safety Administration, DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval and invites public comment. The FMCSA requests
approval to revise and extend an existing ICR titled, ``Hazardous
Materials Safety Permits.'' This ICR requires companies holding safety
permits to develop communications plans that allow for the periodic
tracking of the shipments. A record of the communications that includes
the time of the call and location of the shipment may be kept by either
the driver (e.g., recorded in the log book) or the company. These
records must be kept, either physically or electronically, for at least
six months at the company's principal place of business or readily
available to the employees at the company's principal place of
business.

DATES: We must receive your comments on or before January 9, 2017.

ADDRESSES: You may submit comments identified by Federal Docket
Management System (FDMS) Docket Number FMCSA-2016-0359 using any of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200

New Jersey Avenue SE., West Building, Ground Floor, Room W12-140,
20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9
a.m. and 5 p.m. e.t., Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number. For detailed instructions on submitting comments see the
Public Participation heading below. Note that all comments received
will be posted without change to http://www.regulations.gov, including
any personal information provided. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov, and follow the
online instructions for accessing the dockets, or go to the street
address listed above.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement for the Federal Docket Management System
published in the Federal Register on January 17, 2008 (73 FR 3316), or
you may visit http://edocket.access.gpo.gov/2008/pdfE8-794.pdf.
    Public Participation: The Federal eRulemaking Portal is available
24 hours each day, 365 days each year. You can obtain electronic
submission and retrieval help and guidelines under the ``help'' section
of the Federal eRulemaking Portal Web site. If you want us to notify
you that we received your comments, please include a self-addressed,
stamped envelope or postcard, or print the acknowledgement page that
appears after submitting comments online. Comments received after the
comment closing date will be included in the docket and will be
considered to the extent practicable.

FOR FURTHER INFORMATION CONTACT: Mr. Vincent Babich or Mr. Tyrone
Gibbs, Office of Enforcement and Compliance, Hazardous Materials
Division, Department of Transportation, FMCSA, West Building 6th Floor,
1200 New Jersey Avenue SE., Washington, DC 20590. Telephone: 202-366-
4871 or<PHONE_NUMBER>; email<EMAIL_ADDRESS>or
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Background: The Secretary of Transportation (Secretary) is
responsible for implementing regulations to issue safety permits for
transporting certain hazardous materials (HM) in accordance with 49
U.S.C. 5101 et seq. The HM Safety Permit regulations (49 CFR part 385,
subpart E) require carriers to develop and maintain route plans so that
law enforcement officials can verify the correct location of the HM
shipment. The FMCSA requires companies holding safety permits to
develop a communications plan that allows for the periodic tracking of
the shipment. This ICR covers the record of communications that
includes the time of the call and location of the shipment. The records
may be kept by either the driver (e.g., recorded in the log book) or
the company. These records must be kept, either physically or
electronically, for at least six months at the company's principal
place of business or be readily available to employees at the company's
principal place of business. The currently-approved information
collection is based on an estimated 1,382 respondents. The total number
of companies now holding a safety permit is 1,304 therefore in this ICR
the estimated number of respondents is being revised to reflect this
number.
    Title: Hazardous Materials Safety Permits.
    OMB Control Number: 2126-0030.
    Type of Request: Revision and extension of a currently-approved
information collection.
    Respondents: Motor carriers subject to the HM Safety Permit
requirements in 49 CFR part 385, subpart E.
    Estimated Number of Respondents: 1,304.
    Estimated Time per Response: 5 minutes. The communication between
motor carriers and their drivers must take place at least two times per
day. It is estimated that it will take 5 minutes to maintain a daily
communication record for each driver.
    Expiration Date: July 31, 2017.
    Frequency of Response: On occasion.
    Estimated Total Annual Burden: 908,000 hours [10.9 million trips x
5 minutes per record / 60 minutes per hour = 908,333.33 rounded to
908,000].
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the performance of FMCSA's functions; (2)
the accuracy of the estimated burden; (3) ways for FMCSA to enhance the
quality, usefulness, and clarity of the collected information; and (4)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize or include your
comments in the request for OMB's clearance of this information
collection.

    Issued under the authority of 49 CFR 1.87 on: October 27, 2016.
Kelly Regal,
Associate Administrator for Office of Research and Information
Technology.
[FR Doc. 2016-26559 Filed 11-9-16; 8:45 am]
 BILLING CODE 4910-EX-P