[Federal Register Volume 86, Number 42 (Friday, March 5, 2021)]
[Notices]
[Pages 12986-12987]
[FR Doc No: 2021-04558]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2009-0026]

Bureau Veritas Consumer Products Services, Inc.: Grant of Renewal
of Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: In this notice, OSHA announces the final decision to grant
renewal of recognition to Bureau Veritas Consumer Products Services,
Inc. as a Nationally Recognized Testing Laboratory (NRTL).

DATES: The renewal of recognition becomes effective on March 5, 2021.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, phone:
(202) 693-2110 or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice that it is granting the renewal of
recognition of Bureau Veritas Consumer Products Services (BVCPS) as a
NRTL under 29 CFR 1910.7.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements in Section 1910.7 of Title 29, Code of Federal
Regulations (29 CFR 1910.7). Recognition is an acknowledgment that the
organization can perform independent safety testing and certification
of the specific products covered within the scope of recognition and is
not a delegation or grant of government authority. As a result of
recognition, employers may use products properly approved by the NRTL
to meet OSHA standards that require testing and certification. OSHA
maintains an informational web page for each NRTL that details the
scope of recognition available at http://www.osha.gov/dts/otpca/nrtl/index.html.
    OSHA processes applications submitted by an NRTL for renewal of
recognition following requirements in Appendix A to 29 CFR 1910.7. OSHA
conducts renewals in accordance with the procedures in 29 CFR 1910.7,
App. A II.C. In accordance with these procedures, NRTLs submit a
renewal request to OSHA between nine months and one year before the
expiration date of the current recognition. A renewal request includes
a request for renewal and any additional information demonstrating
their continued compliance with the terms of the recognition and 29 CFR
1910.7. If OSHA has not conducted an on-site assessment of the NRTL
headquarters and any key sites within the past 18 to 24 months, it will
schedule the necessary on-site assessment prior to the expiration date
of the NRTL's recognition. Upon review of the submitted material and,
as necessary, the successful completion of the on-site assessment, OSHA
announces the preliminary decision to grant or deny renewal in the
Federal Register and solicits comments from the public. OSHA then
publishes a final Federal Register notice responding to any comments
and renewing the NRTL's recognition for a period of five years, or
denying the renewal of recognition.
    BVCPS initially received OSHA recognition as a NRTL on May 8, 2000
(65 FR 26637), for a five-year period ending on January 25, 2007.
Renewal of this recognition was granted on April 22, 2014, for a five
year period ending on April 22, 2019. BVCPS submitted a timely request
for renewal, dated May 25, 2018 (OSHA-2009-0026-0082), and retains
their recognition pending OSHA's final decision in this renewal
process. The current address of the BVCPS facility recognized by OSHA
and included as part of the renewal request is Bureau Veritas Consumer
Products Services, Inc., Littleton Distribution Center, One
Distribution Center Circle, Suite #1, Littleton, Massachusetts 01460.
    OSHA evaluated BVCPS's application for renewal and made a
preliminary determination that BVCPS can continue to meet the
requirements prescribed by 29 CFR 1910.7 for recognition.
    OSHA published the preliminary notice announcing BVCPS's renewal
application in the Federal Register on July 13, 2020 (85 FR 42022). The
agency requested comments by July 28, 2020, and received no comments in
response to this notice. OSHA is now proceeding with this final notice
to renew BVCPS NRTL recognition.
    To obtain or review copies of all public documents pertaining to
the BVCPS's application, go to www.regulations.gov or contact the
Docket Office, Occupational Safety and Health Administration, U.S.
Department of Labor, 200 Constitution Avenue NW, Room N-3655,
Washington, DC 20210; telephone<PHONE_NUMBER>. Docket No. OSHA-2009-
0026 contains all materials in the record concerning BVCPS's NRTL
recognition. Please note: Due to the COVID-19 pandemic, the Docket
Office is closed to the public at this time but can be contacted at
(202) 693-2350.

II. Final Decision and Order

    OSHA hereby gives notice of the renewal of recognition of BVCPS as
a NRTL. OSHA examined BVCPS's renewal application and all pertinent
information related to BVCPS's request for renewal of NRTL recognition.
Based on this review of the renewal request and other pertinent
information, OSHA finds that BVCPS meets the requirements of 29 CFR
1910.7 for renewal of recognition as a NRTL, subject to the specified
limitation and conditions. OSHA limits the renewal of BVCPS's
recognition to include the terms and conditions of BVCPS's recognition
found in 65 FR 26637. The NRTL scope of recognition for BVCPS is also
available on the OSHA website at: https://www.osha.gov/dts/otpca/nrtl/csl.html. This renewal extends BVCPS's recognition as a NRTL for a
period of five years from March 5, 2021.

A. Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
BVCPS must abide by the following conditions of recognition:
    1. BVCPS must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in their operations as a NRTL, and provide details of the
change(s);
    2. BVCPS must meet all the terms of their recognition and comply
with all OSHA policies pertaining to this recognition; and
    3. BVCPS must continue to meet the requirements for recognition,
including all previously published conditions on BVCPS's scope of
recognition, in all areas for which it has recognition.
    Pursuant to the authority in 29 CFR 1910.7, OSHA hereby renews the
recognition of BVCPS as a NRTL.

III. Authority and Signature

    Amanda L. Edens, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW, Washington,
DC 20210, authorized the preparation of this notice. Accordingly, the
agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2)),
Secretary of Labor's Order No. 8-2020 (85 FR 58393, Sept. 18, 2020),
and 29 CFR 1910.7.

    Signed at Washington, DC, on March 1, 2021.
Amanda L. Edens,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2021-04558 Filed 3-4-21; 8:45 am]
BILLING CODE 4510-26-P


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460
                                                                      OFFICE OF
                                                            CHEMICAL SAFETY AND

\* MERGEFORMAT
                                                           POLLUTION PREVENTION

MEMORANDUM

DATE:	June 14, 2012

SUBJECT:	REVISED Trifloxystrobin.  Human Health Risk Assessment Analysis for Proposed New Use on Globe Artichokes and Waiver Requests for 28-Day Inhalation Toxicity and Subchronic Neurotoxicity Studies.

PC Code:  129112
DP Barcode:  388187, 388434
Decision No.:  445968, 445971
Registration No.:  264-776, 777, 826
Petition No.:  1F7845
Regulatory Action:  Section 3
Risk Assessment Type:  Single Chemical/Aggregate
Case No.:  NA
TXR No.:  NA
CAS No.:  141517-21-7
MRID No.:  NA
40 CFR:  180.555

FROM:	Nancy Tsaur, Chemist, Risk Assessor
	Risk Assessment Branch 3
	Health Effects Division (7509P)

THROUGH:	Paula Deschamp, Branch Chief
	Risk Assessment Branch 3
	Health Effects Division (7509P)

TO:	Tony Kish/Janet Whitehurst, Risk Manager Team 22
	Fungicides Branch
	Registration Division (7505P)

RD requested that HED provide an evaluation of the proposed tolerance for trifloxystrobin in/on artichoke, globe.  HED concludes that a new human health aggregate risk assessment is not needed for this petition.

There are no changes to trifloxystrobin dietary exposure from food and/or drinking water, nor any changes to residential exposure resulting from the proposed tolerance of 1.0 ppm.

In addition to the tolerance evaluation, this document addresses the responses to two waiver requests for: 28-Day Inhalation Exposure Toxicity and Subchronic Neurotoxicity.
Table of Contents

1.0	Executive Summary	3
2.0	HED Recommendations	3
2.1	Data Deficiencies/Conditions of Registration	3
2.2	Recommended Tolerances	4
3.0	Introduction	4
3.1	Chemical Identity	4
3.2	Pesticide Use Pattern	5
4.0	Hazard Characterization and Dose-Response Assessment	6
4.1	Safety Factor for Infants and Children (FQPA Safety Factor)	6
4.1.2	Evidence of Neurotoxicity	6
4.1.3	Evidence of Sensitivity/Susceptibility in the Developing or Young Animal	7
4.1.4	Residual Uncertainty in the Exposure Database	7
5.0	Dietary Exposure and Risk Assessment	7
6.0	Residential (Non-Occupational) Exposure/Risk Characterization	8
7.0	Aggregate Exposure/Risk Characterization	8
1.0	Executive Summary

In PP#1F7845, Bayer Cropscience (Bayer) has petitioned for the establishment of a new tolerance for combined residues of the fungicide trifloxystrobin [benzeneacetic acid, (E,E)-α-(methoxyimino)-2-[[[[1-[3-(trifluoromethyl)phenyl]ethylidene] amino]oxy]methyl]-methyl ester] and the free form of its acid metabolite CGA-321113 [(E,E)-(methoxyimino)-[2-[1-(3-(trifluoromethylphenyl)-ethylideneaminooxymethyl]-phenyl]acetic acid] in/on the following raw agricultural commodities (RAC):
            Artichoke, globe	1.0 ppm

The most recent human health risk assessment was conducted for use on imported coffee in which the hazard characterization and toxicity endpoints for risk assessment were reported (DP#379110, N. Tsaur, 02/28/2011).  Since then, a waiver request for a 28-day inhalation exposure toxicity study was submitted and denied, and a waiver request for a subchronic neurotoxicity (SCN) study was submitted and accepted.  Other then the waiver requests, the hazard characterization and toxicity endpoints for risk assessment remain unchanged.  The details of the hazard characterization and the rationale for toxicity endpoint selection will not be repeated in this risk assessment.  However, the salient features for the Food Quality Protection Act (FQPA) safety factor will be summarized.

A summary of the findings and a discussion of human health risk resulting from the proposed tolerance of trifloxystrobin are provided in this document.  This assessment has been conducted by Nancy Tsaur.

2.0	HED Recommendations

There are no data deficiencies that preclude establishment of a permanent tolerance for combined residues of trifloxystrobin in/on globe artichokes.

2.1	Data Deficiencies/Conditions of Registration

Toxicology [870.7800 Immunotoxicity]
   In 2007, the Agency revised 40CFR Part 158.500 Toxicology data requirements to include functional immunotoxicity testing and granted a 2-year grace period to allow time for registrants to develop the required data. The registrant has informed the Agency of their intent to submit an immunotoxicity study as a condition of registration (the study was scheduled to be conducted in 2011).

Toxicology [870.3465 28-Day Inhalation Toxicity]
   Prior to 2010, the Agency frequently relied on oral toxicity studies to conduct inhalation risk assessments.  In December 2009, the Agency sought expert advice and input from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) on issues related to this route to route extrapolation approach in the absence of an inhalation toxicity study (i.e. the use of oral toxicity studies for inhalation risk assessment).  Based on the SAP's recommendations in the March 2, 2010 Final Report (http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html), the Agency has increased its focus on the uncertainties associated with route-to-route extrapolation and is presently requiring inhalation toxicity studies more frequently.   The Agency has concluded that an inhalation toxicity study is required as a condition of registration to fully characterize the risk from inhalation exposure to trifloxystrobin.

2.2	Recommended Tolerances

Table 2.2. 	Tolerance Summary for Trifloxystrobin
                                   Commodity
                                Tolerance (ppm)
                                   Comments
                         Correct Commodity Definition

                                  Established
                                   Proposed
                                  Recommended

                            40 CFR §180.609(a)(1)
                               Artichoke, globe
                                      --
                                      1.0
                                      1.0

3.0	Introduction

In 2010 (PP#8F7464), Bayer submitted a petition for tolerance on globe artichokes.  Subsequently, HED reviewed the submitted field trial data and concluded that the data did support the proposed tolerance of 1.0 ppm in a previous risk assessment (B. Hanson, DP#360305, 12/09/2010).  To support the risk assessment recommendation, both acute and chronic dietary risk estimates incorporated the proposed tolerance level of 1.0 ppm for globe artichokes (B. Hanson, DP#379505, 09/28/2010).  However, Bayer later withdrew the petition for tolerance in/on globe artichokes prior to the establishment of a permanent tolerance.

Now, in 2011 (PP#1F7845), Bayer has submitted a new petition for a tolerance of 1.0 ppm for residues of trifloxystrobin in/on globe artichokes.  With the petition, Bayer has submitted amended labels for Flint(R) Fungicide (EPA Reg. No. 264-777) and Gem(TM) 500 SC Fungicide (EPA Reg. No. 264-826) to include use on globe artichokes.  Flint(R) is a water dispersible granule (WG) formulation consisting of 50% trifloxystrobin by weight whereas Gem(TM) 500 SC is a suspension concentrate (SC) formulation consisting of 4.17 lb trifloxystrobin per gallon of product.

Along with this petition for tolerance, Bayer has submitted two waiver requests: one for a 28-day inhalation exposure toxicity study (Guideline 870.3465), and one for the subchronic neurotoxicity (SCN) study of the neurotoxicity battery (Guideline 870.6200b).  Upon review of the waiver requests, HED determined that a 28-day inhalation exposure toxicity study will be required based on a weight of evidence approach: HED considered the trifloxystrobin use pattern, all relevant hazard and exposure information, in addition to the current OPP guidance for waiving inhalation studies.  Therefore, HED concluded to deny the waiver request for the 28-day inhalation exposure toxicity study.  However, regarding the SCN, HED determined that there is no concern for neurotoxicity for trifloxystrobin based on the available database, limited findings in an acute neurotoxicity (ACN) study, and lack of neurotoxicity in other fungicides of the strobilurin class.  Therefore, HED concluded to grant the waiver request for an SCN study (DP#385650, TXR#0056113, Sheila Healy, 01/06/2012).

3.1	Chemical Identity

Trifloxystrobin is a strobilurin-class fungicide (also termed methoxyacrylates) that controls foliar fungal diseases and soilborne/seedling fungal diseases.  It works by interrupting mitochondrial respiration in plant-pathogenic fungi, thus inhibiting spore germination and mycelial growth.  It is a broad-spectrum preventative fungicide used for control of many plant diseases in various fruit, nut, vegetable, and field crops, including corn and soybean.  Trifloxystrobin is described in Table 3.1.

Table  3.1.  Trifloxystrobin Nomenclature
Chemical Structure

Empirical Formula
C20H19F3N2O4
Common name
trifloxystrobin
Company experimental name
BO17211 or CGA-279202
IUPAC name
methyl (E)-methoxyimino-{(E)-α-[1-(α,α,α-trifluoro-m-tolyl)ethylideneaminooxy]-o-tolyl}acetate
CAS name
methyl (αE)-α-(methoxyimino)-2-[[[[(1E)-1-[3-(trifluoromethyl)phenyl]ethylidene]amino]oxy]methyl]benzeneacetate
CAS Registry Number
141517-21-7
End-Use Products (EPs)
Flint(R) Fungicide (50% ai); Gem(TM) 500 SC (4.17 lb ai/gallon)
Chemical Class
Strobilurin, methoxyacrylates
Known Impurities of Concern
None

3.2	Pesticide Use Pattern

Bayer submitted amended labels for Flint(R) Fungicide (EPA Reg. No. 264-777) and Gem(TM) 500 SC Fungicide (EPA Reg. No. 264-826) to include use on globe artichokes.  Flint(R) WG formulation consisting of 50% trifloxystrobin by weight whereas Gem(TM) 500 SC is an SC formulation consisting of 4.17 lb trifloxystrobin per gallon of product.  A summary of the directions for use are listed in Table 3.2.

Table 3.2.  Summary of Directions for Use of Trifloxystrobin
                       Applic. Timing, Type, and  Equip.
                          Formulation (EPA Reg. No.)
                                 Applic. Rate
                          Max. No. Applic. per Season
                          Max. Seasonal Applic. Rate
                                     PHI
                        Use Directions and Limitations

                                    lb ai/A

                                    lb ai/A
                                     days

                                    Peanut
                                  Groundboom,
                                    Aerial,
                                 Airblast, or
                                  Chemigation
                                    Flint(R)
                           Water Dispersible Granule
                                   (264-777)
                                  0.10 -0.125
                                       2
                                     0.25
                                       0
To control Powdery mildew (Leveillula taurica). Applications should begin when conditions are favorable for diseases but before infection.  RTI = 7 to 10 days.

                                 Gem(TM) 500 SC
                            Suspension Concentrate
                                   (264-826)

4.0	Hazard Characterization and Dose-Response Assessment

References:
   oo Trifloxystrobin.  Human Health Risk Assessment for Proposed New Use on Imported Coffee. DP#385972, Nancy J. Tsaur, 08/02/2011.

A detailed hazard characterization with a list of available toxicity studies for trifloxystrobin is presented in the previous risk assessment (DP#385972, N. Tsaur, 08/02/2011).  The submitted toxicology studies are of good quality and provide sufficient information to determine whether trifloxystrobin poses a human health hazard.

In addition to the existing database, Bayer has submitted two waiver requests: one for a 28-day inhalation exposure toxicity study (Guideline 870.3465), and one for the SCN study of the neurotoxicity battery (Guideline 870.6200b).  Upon review of the waiver requests, HED determined that a 28-day inhalation exposure toxicity study will be required based on a weight of evidence approach: HED considered the trifloxystrobin use pattern, all relevant hazard and exposure information, in addition to the current OPP guidance for waiving inhalation studies.  Therefore, HED concluded to deny the waiver request for the 28-day inhalation exposure toxicity study.  However, regarding the SCN, HED determined that there is no concern for neurotoxicity for trifloxystrobin based on the available database, limited findings in an ACN study, and lack of neurotoxicity in other fungicides of the strobilurin class.  Therefore, HED concluded to grant the waiver request for an SCN study (DP#385650, TXR#0056113, Sheila Healy, 01/06/2012).

4.1	Safety Factor for Infants and Children (FQPA Safety Factor)

The toxicology and exposure data and have been evaluated and trifloxystrobin has been determined to be safe for infants and children, supporting the reduction of the FQPA safety factor to 1X.

4.1.1	Completeness of the Toxicology Database

The toxicity database for trifloxystrobin is complete with the exception of an immunotoxicity study and a 28-day inhalation toxicity study.  A waiver for a subchronic neurotoxicity study has been granted.  Although immunotoxicity and inhalation studies are needed to complete the database, the entire trifloxystrobin toxicity database was examined; the database of this chemical shows no indication that this chemical directly targets the immune system, and there are no uncertainties with respect to residential inhalation exposures.

4.1.2	Evidence of Neurotoxicity

There is no evidence of neurotoxicity in subchronic and chronic toxicity studies (rats, dogs, mice), in developmental toxicity studies (rats, rabbits), or in a reproductive toxicity study (rats).  There is no concern for neurotoxicity for trifloxystrobin based on the available database, limited findings in an ACN study, and lack of neurotoxicity in other fungicides of the strobilurin class.

4.1.3	Evidence of Sensitivity/Susceptibility in the Developing or Young Animal

There is no indication of increased quantitative or qualitative susceptibility to trifloxystrobin in rats or rabbits.  In the prenatal developmental study in rats, there was no developmental toxicity at the limit dose.  In the prenatal developmental study in rabbits, developmental toxicity was seen at a dose that was higher than the dose that caused maternal toxicity.  In the multi-generation study, offspring and parental LOAELs are at the same dose level.

4.1.4	Residual Uncertainty in the Exposure Database

The exposure assessments will not underestimate the potential dietary (food and drinking water) or non-dietary exposures for infants and children from the use of trifloxystrobin.  The main contribution to total aggregate exposure is from the dietary route.  The acute dietary assessment was unrefined, assuming conservative upper bound inputs including 100% crop treated and tolerance-level residues.  The chronic dietary assessment was partially refined, assuming 100% crop treated and tolerance-level residues for all commodities except for apples, grapes, and oranges where the average field trial residues were used.  Although the chronic assessment included these minor refinements, the use of representative field trial data ensures that actual exposures/risks from residues in food will not be underestimated.  The dietary drinking water assessment utilizes water concentration values generated by models and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations, and are not likely to be exceeded.  In addition, the residential post-application exposure assessment is based upon the residential SOPs employing surrogate study data, including conservative exposure assumptions based on Day 0 dermal contact to turf treated at the maximum application rate.  These data are reliable and are not expected to underestimate risk to adults or children.  The residential SOPs are based upon reasonable "worst-case" assumptions and are not expected to underestimate risk.

4.2	Summary of Points of Departure and Endpoints Used in Human Risk Assessment

The summary of toxicological doses and endpoints supporting this petition remain unchanged and have been summarized in the previous human health risk assessment (DP#385972, N. Tsaur, 08/02/2011) as well as the most recent Federal Register Notice (EPA-HQ-OPP-2011-0456-0004, FRN Vol. 76, No. 217, pp. 69648, 11/09/2011).

5.0	Dietary Exposure and Risk Assessment

References:
   oo Trifloxystrobin.  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Petition for Establishment of a Tolerance on Imported Coffee. DP#387201, Nancy J. Tsaur, 07/13/2011.

There were no appropriate toxicological effects attributable to a single exposure (dose) for the general population or any other population subgroups other than females 13-49 years old.  The most recent acute and chronic dietary exposure assessments conducted for trifloxystrobin included the proposed tolerance for globe artichokes.  The results of both acute and chronic dietary exposure analyses remain unchanged and are reported in Table 5.0.   The acute dietary (food + drinking water) assessment was unrefined, and the chronic dietary (food + drinking water) assessment was partially refined, assuming 100% crop treated and tolerance-level residues for all commodities except for apples, grapes, and oranges where the average field trial residues were used.  Trifloxystrobin is classified as "not likely to be carcinogenic to humans" and thus cancer risk is not expected.

 Table 5.0.  Summary of Dietary Exposure and Risk for Trifloxystrobin
                              Population Subgroup
                                 Acute Dietary
                           (Food and Drinking Water)
                                Chronic Dietary
                           (Food and Drinking Water)

                               Dietary Exposure
                                    % aPAD*
                                Dietary Exposure
                                    % cPAD*

                                   mg/kg/day

                                   mg/kg/day

 General U.S. Population
                                      N/A
                                    0.013067
                                       34
 Children 1-2 years old

                                    0.024165
                                       64
 Females 13-49 years old
                                   0.047424
                                      1.9
                                    0.012206
                                       32

6.0 Residential (Non-Occupational) Exposure/Risk Characterization

References:
   oo Occupational and Residential Risk Assessment for Section 3 Petition to Register New Uses of Trifloxystrobin on Barley, Oats, Sweet Corn, and for the Treatment of Sweet Corn Seed.  DP#319193, Jack Arthur, 07/14/2005.

According to the labels, the currently registered residential products are restricted to use by Certified Pest Control Operators (PCOs) only.  Therefore, an assessment for residential handlers was not conducted.  Additionally, residential risk estimates cannot be combined because the toxic effects are different via different routes of exposure.  Thus, the risk estimates resulting from post-application exposure scenarios remain unchanged from the previous assessment and are summarized in Table 6.0.

Table 6.2.  Short- and Intermediate-Term Residential Post-Application Exposure and Risk Estimates for Trifloxystrobin
                                  Population
                         Post-Application Exposure [1]
                                   mg/kg/day
                  Residential Post-Application Total Exposure
                                   mg/kg/day
                                      MOE

                                    Dermal
                                  Inhalation
                                     Oral

                                     Adult
                                     0.079
                                      NA
                                      NA
                                     0.079
                                     1300
                                     Child
                                     0.13
                                      NA
                                      NA
                                     0.13
                                      770

                                      NA
                                      NA
                                    0.0051
                                    0.0051
                                      750
[1]	Post-application exposure represents high end incidental oral exposure for the relevant exposure duration (hand-to-mouth).

7.0 Aggregate Exposure/Risk Characterization

The aggregate risk calculation remains unchanged since the last risk assessment because the proposed tolerance for globe artichokes has been previously incorporated into the dietary risk estimates, and residential risk estimates remain unchanged.  Chronic exposures via the dietary (food and drinking water) route are summarized in Section 5.0.  Short- and intermediate-term risk estimates are summarized in Table 7.0.  An aggregate cancer assessment was not conducted because trifloxystrobin is classified as "not likely to be carcinogenic to humans."

This assessment has taken into consideration the changes in the new Residential Standard Operating Procedures (SOPs) to be implemented in January of 2012.  HED finds no changes that would affect the aggregate safety finding and confirms that there are no risks of concern resulting from setting a tolerance for trifloxystrobin in/on globe artichokes, nor from utilizing the new Residential SOPs to estimate residential exposure and risk.

Table 7.0.  Short- and Intermediate Term Aggregate Risk Calculations
                                  Population
                     Short- and Intermediate-Term Scenario

                                     NOAEL
                                    LOC [1]
                        Average Food and Water Exposure
                        Residential Dermal Exposure [2]
                         Residential Oral Exposure [2]
                              Total Exposure [3]
               Aggregate MOE (food, water, and residential) [4]

                                   mg/kg/day

                                   mg/kg/day
                                   mg/kg/day
                                   mg/kg/day
                                   mg/kg/day

                                     Adult
                                      100
                                      100
                                    0.03067
                                     0.079
                                      NA
                                   0.092067
                                     1,100
                               Children (Dermal)
                                 1-2 years old
                                      100
                                      100
                                   0.024165
                                     0.13
                                      NA
                                   0.154165
                                      650
                                Children (Oral)
                                 1-2 years old
                                      3.8
                                      100
                                   0.024165
                                      NA
                                    0.0051
                                   0.029265
                                      130
[1]	LOC = level of concern.
[2]	Residential Dermal and Oral Exposures cannot be combined (Table 6.2).
[3]	Total Exposure = Avg Food & Water Exposure + Residential Exposure.
[4]	Aggregate MOE = [NOAEL / (Avg Food & Water Exposure + Residential Exposure)].


[Federal Register: June 8, 2009 (Volume 74, Number 108)]
[Notices]
[Page 27145-27146]
[DOCID:fr08jn09-55]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0251]

Agency Information Collection Activities; Proposed Collection;
Comment Request; User Fee Cover Sheet; Form FDA 3397

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on Form FDA 3397, User Fee Cover
Sheet, that must be submitted along with certain drug and biologic
product applications and supplements.

DATES: Submit written or electronic comments on the collection of
information by August 7, 2009.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comment on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.

User Fee Cover Sheet; Form FDA 3397--(OMB Control Number 0910-0297)--
Extension

    Under sections 735 and 736 of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 379g and 379h), the Prescription Drug
User Fee Act of 1992 (PDUFA) (Public Law 102-571), as amended by the
Food and Drug Administration Modernization Act of 1997 (Public Law 105-
115), the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, which includes the Prescription Drug User Fee
Amendments of 2002 (Public Law 107-188), and most recently by the Food
and Drug Administration

Amendments Act of 2007 (Public Law 110-85), FDA has the authority to
assess and collect user fees for certain drug and biologics license
applications and supplements. Under this authority, pharmaceutical
companies pay a fee for certain new human drug applications, biologics
license applications, or supplements submitted to the agency for
review. Because the submission of user fees concurrently with
applications and supplements is required, review of an application by
FDA cannot begin until the fee is submitted. Form FDA 3397, the user
fee cover sheet, is designed to provide the minimum necessary
information to determine whether a fee is required for review of an
application, to determine the amount of the fee required, and to
account for and track user fees. The form provides a cross-reference of
the fee submitted for an application by using a unique number tracking
system. The information collected is used by FDA's Center for Drug
Evaluation and Research (CDER) and Center for Biologics Evaluation and
Research (CBER) to initiate the administrative screening of new drug
applications, biologics license applications, and supplemental
applications.
    Respondents to this collection of information are new drug and
biologics manufacturers. Based on FDA's database system for fiscal year
(FY) 2008, there are an estimated 255 manufacturers of products subject
to the user fee provisions of PDUFA. However, not all manufacturers
will have any submissions, and some may have multiple submissions in a
given year. The total number of annual responses is based on the number
of submissions received by FDA in FY 2008. CDER received 3,107 annual
responses that include the following submissions: 147 new drug
applications; 13 biologics license applications; 1,813 manufacturing
supplements; 987 labeling supplements; and 147 efficacy supplements.
CBER received 810 annual responses that include the following
submissions: 9 biologics license applications; 743 manufacturing
supplements; 48 labeling supplements; and 10 efficacy supplements.
Based on the previous submissions that were received, the rate of these
submissions is not expected to change significantly in the next few
years. The estimated hours per response are based on past FDA
experience with the various submissions, and the average is 30 minutes.
    FDA is revising Form FDA 3397 in the following ways: (1) By
including an additional question regarding redemption of a priority
review voucher; (2) by deleting the exclusion for certain applications
submitted under section 505(b)(2) of the FD&C Act (21 U.S.C.
355(b)(2)); and (3) by making several minor editorial changes.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
     Form          Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
FDA 3397                      255                 15.36              3,917                0.5              1,959
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: June 1, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-13276 Filed 6-5-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Proposed Rules]
[Pages 19094-19097]
[FR Doc No: 2016-07662]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-1057]
RIN 1625-AA09

Drawbridge Operation Regulation; Norwalk River, Norwalk, CT

AGENCY: Coast Guard, DHS.

ACTION: Supplemental Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to modify the operating schedule that
governs the Metro-North WALK Bridge across the Norwalk River, mile 0.1,
at Norwalk, Connecticut. The bridge owner submitted a request to
require a greater advance notice for bridge openings and to increase
time periods the bridge remains in the closed position during the
weekday morning and evening rush hours. It is expected that this change
to the regulations will create efficiency in drawbridge operations
while continuing to meet the reasonable needs of navigation.

DATES: Comments and related material must reach the Coast Guard on or
before May 4, 2016.

ADDRESSES: You may submit comments identified by docket number USCG-
2014-1057 using Federal eRulemaking Portal at http://www.regulations.gov.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
supplemental proposed rule, call or email Mr. Chris Bisignano, Project
officer, First Coast Guard District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
E.O. Executive order
FR Federal Register
NPRM Notice of proposed rulemaking
SNPRM Supplemental notice of proposed rulemaking
Pub. L. Public Law
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On August 31, 2015, we published a notice of proposed rulemaking
(NPRM) entitled, Drawbridge Operation Regulation; Norwalk River,
Norwalk, CT, in the Federal Register (80 FR 52423), soliciting comments
on the proposed rule through October 30, 2015. In addition, Commander
(dpb), First Coast Guard District published Public Notice 1-149 dated
September 21, 2015. We received four submissions on the proposed rule,
which will be addressed in Section III, below.
    The Metro-North WALK Bridge, mile 0.1, across the Norwalk River at
Norwalk, Connecticut, has a vertical clearance in the closed position
of 16 feet at mean high water and 23 feet at mean low water. The
drawbridge operation regulations are listed at 33 CFR 117.217(b). The
waterway users are seasonal recreational vessels and commercial vessels
of various sizes.
    The owner of the bridge, Connecticut Department of Transportation
(CDOT), requested a change to the Drawbridge Operation Regulations
because the volume of train traffic across the bridge during the peak
commuting hours makes bridge openings impractical under the current
schedule. As a result, bridge openings that occur during peak commuter
train hours cause significant delays to commuter rail traffic.
    The NPRM published in August 2015 would have permanently changed
the operating hours during the Monday-Friday, excluding holidays,
timeframes to operate as follows:
    (1) The draw shall open on signal between 4:30 a.m. and 9 p.m.
after at least a two hour advance notice is given; except that, from
4:30 a.m. through 9:30 a.m. and from 4 p.m. through 9 p.m., Monday
through Friday excluding holidays, the draw need not open for the
passage of vessel traffic unless an emergency exists.
    (2) From 9 p.m. through 4:30 a.m. the draw shall open on signal
after at least a four hour advance notice is given.
    In response to the comments received and after further review of
bridge logs and train schedules, the Coast Guard now proposes to modify
the NPRM by adjusting when the draw will be available to open Monday
through Friday, excluding holidays as follows:
    (1) The draw shall open on signal between 4:30 a.m. and 9 p.m.
after at least a two hour advance notice is given; except that, from
5:45 a.m. through 9:45 a.m. and from 4 p.m. through 8 p.m., Monday
through Friday excluding holidays, the draw need not open for the
passage of vessel traffic unless an emergency exists.
    (2) From 9 p.m. through 4:30 a.m. the draw shall open on signal
after at least a four hour advance notice is given.

III. Discussion of Comments and Change

    We received four submissions commenting on the NPRM. Three
submissions opposed and one submission supported the proposed changes.
Some submissions commented on multiple aspects of the proposed
regulation. The Coast Guard considered all comments and the responses
from CDOT in creation of this supplemental alternative proposal.
    One comment suggested a meeting to deliberate the changes proposed
in this rulemaking. The Coast Guard met with all parties that expressed
interest in this rulemaking on May 11, 2015. The Coast Guard does not
see a need to hold additional public meetings at this time.
    One comment requested that any modification to the existing rule
should not be extended past the initiation of construction of a new
replacement bridge. The Coast Guard disagrees. A replacement bridge is
only in the planning stage at CDOT. Design and construction of a
replacement project for a bridge of this scale typically takes several
years. As the timeline of a potential bridge replacement is uncertain,
the Coast Guard cannot consider it within this rulemaking.
    One comment suggested that any change in the operating regulations
for the Metro-North WALK bridge should take into consideration the
operating rule of the downstream SR136 (Washington Street) Bridge to
facilitate the movement of waterborne commerce. The Coast Guard agrees
that the operating schedule of the SR136 Bridge is relevant and
considered the operating schedule for SR136 when drafting this
supplemental rulemaking.
    One comment recommended that the Coast Guard consider revising the
4:30 a.m. to 9:30 a.m. opening schedule, Monday through Friday, as only
two trains cross the bridge from 9 a.m. to 9:30 a.m. In response to
this comment, the Coast Guard expanded its analysis of train traffic
densities; this analysis contributed to the adjustments made in this
supplemental rule compared to the proposed rule. These adjustments
shorten from five to four hours the a.m. and p.m. periods provided for
in the ``except that'' language in paragraph (b)(1) of the regulation,
but also shifts the a.m. period to end later in the day.
    Two commenters noted that the added restrictions to opening times
of the bridge would negatively impact aggregate deliveries and require
alternative deliveries by truck, thereby stressing the road system in
the area. Even under the more restrictive test deviation conducted from
January 1, 2015, to June 28, 2015, as discussed in the NPRM, Metro-
North was able to accommodate all of the requests for bridge openings.
Further, review of the bridge logs revealed that in 2014, prior to the
aforementioned test deviation and NPRM, as compared to 2015 during the
test deviation and the NPRM, the difference in the number of requested
bridge openings was negligible. The Coast Guard also reviewed tidal
data for this area in consideration of the types of commercial traffic
known to use this waterway. The combination of these factors
contributed to the adjustments made in this supplemental rule compared
to the proposed rule.
    The Coast Guard believes the supplemental changes balance the needs
of rail and vessel traffic. The proposed changes enhance rail traffic
without significantly affecting vessel traffic.
    In review of the proposed rule and stakeholder comments, the Coast
Guard noted that the term ``emergency,'' as used within the existing
and proposed regulation, was not specifically discussed. The term and
associated required actions by the bridge owner are as defined within
33 CFR 117.31. This proposed rule makes no changes to regulations under
that section. However, the Coast Guard notes that there may be

instances in which emergent conditions beyond those explicitly listed
therein could merit a special opening of the bridge for draft
constrained vessels when tides and the bridge schedule interfere. For
example, if the inventory of seasonally critical home heating oil or
road salt at a facility upstream of the bridge that serves as the
primary supply within the local area is or will soon be exhausted, and
a commercial vessel transit to replenish inventory must occur during an
allowed-closed period of the bridge, this condition may also reasonably
be expected to require a special opening of the bridge to support
public safety. In such cases, the Coast Guard expects that the bridge
owner, and involved local municipality or commercial entity can make
special arrangements as needed.

IV. Discussion of Proposed Rule

    Based on further review of bridge logs and scheduled train
crossings, the Coast Guard now proposes to modify the NPRM,
specifically changing the ``except that'' language in paragraph (b)(1)
of the regulation as indicated above in Section II. This slight
modification would better serve the freedom of navigation without
significantly impacted rail traffic.

V. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive Orders related to rulemaking. Below we summarize our
analyses based on these statutes and Executive Orders and discuss First
Amendment rights of protestors.

1. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This proposed rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the proposed rule has not been reviewed by the
Office of Management and Budget.
    This regulatory action determination is based on the fact that
vessels can still transit the bridge given advanced notice. The
vertical clearance under the bridge in the closed position is
relatively high enough to accommodate most vessel traffic during the
time periods the draw is closed during the morning and evening commuter
rush hours.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities. While some owners or operators of
vessels intending to transit the bridge may be small entities, for the
reasons stated in section V.A above, this proposed rule would not have
a significant economic impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

3. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

4. Federalism and Indian Tribal Government

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section above.

5. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such an expenditure, we do discuss the effects of this
proposed rule elsewhere in this preamble.

6. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.1D, which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions which do not individually or cumulatively have a
significant effect on the human environment. This proposed rule simply
promulgates the operating regulations or procedures for drawbridges.
Normally such actions are categorically excluded from further review,
under figure 2-1, paragraph (32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

7. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.

Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

VI. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this notice, and all public comments, are in
our online docket at http://www.regulations.gov and can be viewed by
following that Web site's instructions. Additionally, if you go to the
online docket and sign up for email alerts, you will be notified when
comments are posted or a final rule is published.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. In Sec.  117.217, revise paragraph (b) to read as follows:

Sec.  117.217  Norwalk River.

* * * * *
    (b) The draw of the Metro-North ``WALK'' Bridge, mile 0.1, at
Norwalk, shall operate as follows:
    (1) The draw shall open on signal between 4:30 a.m. and 9 p.m.
after at least a two hour advance notice is given; except that, from
5:45 a.m. through 9:45 a.m. and from 4 p.m. through 8 p.m., Monday
through Friday excluding holidays, the draw need not open for the
passage of vessel traffic unless an emergency exists.
    (2) From 9 p.m. through 4:30 a.m. the draw shall open on signal
after at least a four hour advance notice is given.
    (3) A delay in opening the draw not to exceed 10 minutes may occur
when a train scheduled to cross the bridge without stopping has entered
the drawbridge lock.
    (4) Requests for bridge openings may be made by calling the bridge
via marine radio VHF FM Channel 13 or the telephone number posted at
the bridge.

    Dated: March 24, 2016.
L.L. Fagan,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2016-07662 Filed 4-1-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 141 (Wednesday, July 23, 2014)]
[Proposed Rules]
[Pages 42716-42718]
[FR Doc No: 2014-17318]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0455; Directorate Identifier 2014-NM-006-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Airbus Model A319 series airplanes, Model A320-211, -212, -214, -231, -
232, and -233 airplanes, and A321 series airplanes. This proposed AD
was prompted by reports that 67during a full scale fatigue test,
several broken frames in certain areas of the cargo compartment have
been found, especially on the cargo floor support fittings and open
tack holes on the left-hand side. This proposed AD would require a
rototest inspection of the open tack holes and rivet holes at the cargo
floor support fittings of the fuselage, modification of the fuselage,
including doing all applicable related investigative actions, and
repair if necessary. We are proposing this AD to detect and correct
cracking in the open tack holes and rivet holes at the cargo floor
support fittings of the fuselage, which could affect the structural
integrity of the airplane.

DATES: We must receive comments on this proposed AD by September 8,
2014.

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, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus, Airworthiness Office--EAS, 1 Rond Point Maurice Bellonte, 31707
Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44
51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

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-2014-
0455; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM 116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-0455;
Directorate Identifier 2014-NM-006-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2013-0310, dated December 20, 2013 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    During a full scale fatigue test, several broken frames in the
cargo compartment area between Frame (FR) 50 and FR 63, have been
found, especially on the cargo floor support fittings and open tack
holes on [the] left hand side.
    This condition, if not detected and corrected, could affect the
structural integrity of the aeroplane.
    For the reason described above, this [EASA] AD requires
repetitive inspections of the frames in the cargo compartment area
and of the cargo floor support fittings and open tack holes on the
left hand (LH) side, and depending on findings the accomplishment of
applicable corrective action(s). This [EASA] AD also requires a
modification, which constitutes terminating action for the
repetitive inspections required by this [EASA] AD.

    The actions in this AD include a rototest inspection for cracking
of the open tack holes and rivet holes at the cargo floor support
fittings of the fuselage, modification of the fuselage, including doing
all applicable related investigative actions, and repair if necessary.
Related investigative actions include rotating probe inspections for
cracking of the holes. You may examine the MCAI in the AD docket on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2014-0455.

Relevant Service Information

    Airbus has issued Service Bulletin A320-53-1257, dated December 21,
2012, and Service Bulletin A320-53-1261, dated December 21, 2012. The

actions described in this service information are intended to correct
the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

``Contacting the Manufacturer'' Paragraph in This Proposed AD

    Since late 2006, we have included a standard paragraph titled
``Airworthy Product'' in all MCAI ADs in which the FAA develops an AD
based on a foreign authority's AD.
    The MCAI or referenced service information in an FAA AD often
directs the owner/operator to contact the manufacturer for corrective
actions, such as a repair. Briefly, the Airworthy Product paragraph
allowed owners/operators to use corrective actions provided by the
manufacturer if those actions were FAA-approved. In addition, the
paragraph stated that any actions approved by the State of Design
Authority (or its delegated agent) are considered to be FAA-approved.
    In an NPRM having Directorate Identifier 2012-NM-101-AD (78 FR
78285, December 26, 2013), we proposed to prevent the use of repairs
that were not specifically developed to correct the unsafe condition,
by requiring that the repair approval provided by the State of Design
Authority or its delegated agent specifically refer to the FAA AD. This
change was intended to clarify the method of compliance and to provide
operators with better visibility of repairs that are specifically
developed and approved to correct the unsafe condition. In addition, we
proposed to change the phrase ``its delegated agent'' to include a
design approval holder (DAH) with State of Design Authority design
organization approval (DOA), as applicable, to refer to a DAH
authorized to approve required repairs for the proposed AD.
    One commenter to the NPRM having Directorate Identifier 2012-NM-
101-AD (78 FR 78285, December 26, 2013), stated the following: ``The
proposed wording, being specific to repairs, eliminates the
interpretation that Airbus messages are acceptable for approving minor
deviations (corrective actions) needed during accomplishment of an AD
mandated Airbus service bulletin.''
    This comment has made the FAA aware that some operators have
misunderstood or misinterpreted the Airworthy Product paragraph to
allow the owner/operator to use messages provided by the manufacturer
as approval of deviations during the accomplishment of an AD-mandated
action. The Airworthy Product paragraph does not approve messages or
other information provided by the manufacturer for deviations to the
requirements of the AD-mandated actions. The Airworthy Product
paragraph only addresses the requirement to contact the manufacturer
for corrective actions for the identified unsafe condition and does not
cover deviations from other AD requirements. However, deviations to AD-
required actions are addressed in 14 CFR 39.17, and anyone may request
the approval for an alternative method of compliance to the AD-required
actions using the procedures found in 14 CFR 39.19.
    To address this misunderstanding and misinterpretation of the
Airworthy Product paragraph, we have changed that paragraph and
retitled it ``Contacting the Manufacturer.'' This paragraph now
clarifies that for any requirement in this proposed AD to obtain
corrective actions from a manufacturer, the action must be accomplished
using a method approved by the FAA, the European Aviation Safety Agency
(EASA), or Airbus's EASA DOA.
    The Contacting the Manufacturer paragraph also clarifies that, if
approved by the DOA, the approval must include the DOA-authorized
signature. The DOA signature indicates that the data and information
contained in the document are EASA-approved, which is also FAA-
approved. Messages and other information provided by the manufacturer
that do not contain the DOA-authorized signature approval are not EASA-
approved, unless EASA directly approves the manufacturer's message or
other information.
    This clarification does not remove flexibility previously afforded
by the Airworthy Product paragraph. Consistent with long-standing FAA
policy, such flexibility was never intended for required actions. This
is also consistent with the recommendation of the Airworthiness
Directive Implementation Aviation Rulemaking Committee to increase
flexibility in complying with ADs by identifying those actions in
manufacturers' service instructions that are ``Required for
Compliance'' with ADs. We continue to work with manufacturers to
implement this recommendation. But once we determine that an action is
required, any deviation from the requirement must be approved as an
alternative method of compliance.

Costs of Compliance

    We estimate that this proposed AD affects 847 airplanes of U.S.
registry.
    We also estimate that it would take about 471 work-hours per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour. Required parts (for the
modification) would cost about $6,570 per product. Based on these
figures, we estimate the cost of this proposed AD on U.S. operators to
be $39,474,435, or $46,605 per product.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this proposed
AD.

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 proposed regulation is
within the scope of that authority because it addresses an unsafe
condition that is likely to exist or develop on products identified in
this rulemaking action.

Regulatory Findings

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

    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

Airbus: Docket No. FAA-2014-0455; Directorate Identifier 2014-NM-
006-AD.

(a) Comments Due Date

    We must receive comments by September 8, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A319-111, -112, -113, -114, -
115, -131, -132, and -133 airplanes; Model A320-211, -212, -214, -
231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211,
-212, -213, -231, and -232 airplanes; certificated in any category;
all manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by reports that during a full scale fatigue
test, several broken frames in certain areas of the cargo
compartment have been found, especially on the cargo floor support
fittings and open tack holes on the left-hand side. We are issuing
this AD to detect and correct cracking in the open tack holes and
rivet holes at the cargo floor support fittings of the fuselage,
which could affect the structural integrity of the airplane.

(f) Compliance

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

(g) Inspection

    At the applicable compliance times specified in paragraphs
(g)(1) through (g)(3) of this AD: Do a rototest inspection for
cracking of the open tack holes and rivet holes at the cargo floor
support fittings of the fuselage between frame (FR) 50 and FR 63 (LH
side only) for Model A320-211, -212, -214, -231, -232, and -233
airplanes, and A321 airplanes; and between FR 53 and FR 63 (LH side
only) for Model A319 airplanes; in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A320-53-1257,
dated December 21, 2012. Repeat the inspection thereafter at
intervals not to exceed 5,000 flight cycles or 10,000 flight hours,
whichever occurs first.
    (1) For airplanes that have equal to or more than 45,000 total
flight cycles or 90,000 total flight hours as of the effective date
of this AD: Do the inspection in paragraph (g) of this AD within
1,000 flight cycles or 2,000 flight hours after the effective date
of this AD, whichever occurs first.
    (2) For airplanes that have equal to or more than 36,200 total
flight cycles or 72,400 total flight hours, but less than 45,000
total flight cycles and 90,000 total flight hours as of the
effective date of this AD: Do the inspection in paragraph (g) of
this AD within 2,000 flight cycles or 4,000 flight hours after the
effective date of this AD, whichever occurs first, but no later than
before the accumulation of 46,000 total flight cycles or 92,000
total flight hours, whichever occurs first.
    (3) For airplanes that have less than 36,200 total flight cycles
and 72,400 total flight hours as of the effective date of this AD:
Do the inspection in paragraph (g) of this AD before exceeding
38,200 total flight cycles or 76,400 total flight hours, whichever
occurs first.

(h) Modification

    Before exceeding 48,000 total flight cycles or 96,000 total
flight hours, whichever occurs first: Modify the fuselage, including
doing all applicable related investigative actions, in accordance
with the Accomplishment Instructions of Airbus Service Bulletin
A320-53-1261, dated December 21, 2012. Do all related investigative
actions before exceeding 48,000 total flight cycles or 96,000 total
flight hours, whichever occurs first. Modification of the fuselage
as required by this paragraph constitutes as a terminating action
for the repetitive inspections required by paragraph (g) of this AD.

(i) Corrective Action

    If any crack is found during any inspection required by this AD:
Before further flight, repair using a method approved by the
Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA; or the European Aviation Safety Agency (EASA); or
Airbus's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, 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 International
Branch, send it to ATTN: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM 116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office. The AMOC approval letter must
specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Airbus's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2013-0310, dated December 20,
2013, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2014-0455.
    (2) For service information identified in this AD, contact
Airbus, Airworthiness Office--EAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Renton, Washington, on July 16, 2014.
John P. Piccola,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-17318 Filed 7-22-14; 8:45 am]
BILLING CODE 4910-13-P


i ; l 1 ) Q la,)+! r ; ; .,

May 4, 2005 Robert W. Varney Regional Administrator U. S. Environmental Protection Agency Region 1 One Congress St. Suite 1100 Boston, MA 02114 h !

Re: Request for Eligibility Determination and Clean Air Act Progra Approval Mohegan Indian Tribe Dear Mr. Varney: RECEIVED M AY 5 2001,

OFFICE OF THE REGIONAL ADMINISTRATOR The Mohegan Tribe of Indians hereby submits for your review and approval its formal Request for Eligibility Determination and Clean Air Act Program Approval pursuant to 42 U. S. C. § 7601 ( d) ( 2) and regulations at 40 CFR Part 49.

Please note that the Tribe is hereby withdrawing its previous submittal that was forwarded to you by letter dated August 29, 2001 .

Enclosed with this letter are the following documents in support of the Tribe's Request:

. The Tribe's Request for Eligibility Determination and Clean Air Act Program Approval which is a ten page document Exhibits 1  15 attached to the Request Memorandum of Agreement between the Mohegan Tribe and EPA signed by Chairman Mark F. Brown Transcript of Public Hearing held in Uncasville on March 25, 2005 and accompanying public notice information We hope that this Request conforms to all of the requirements set forth in your regulations . If you need any additional information or have any questions please advise .

Dale T . White General Counsel Mohegan Tribe


[Federal Register Volume 84, Number 206 (Thursday, October 24, 2019)]
[Notices]
[Pages 57070-57072]
[FR Doc No: 2019-23160]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87357; File No. SR-LTSE-2019-03]

Self-Regulatory Organizations; Long-Term Stock Exchange; Notice
of Filing and Immediate Effectiveness of Proposed Rule Change To Set
the Date of the Pilot Related to the Market-Wide Circuit Breaker in
Rule 11.280 and To Move the Limit Up-Limit Down Mechanism, Authority To
Initiate Trading Halts, and Procedure for Initiating and Terminating a
Trading Halt Into Separate Rules for Clarity

October 18, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''), \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on October 18, 2019, Long-Term Stock Exchange (``LTSE'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    LTSE proposes to untie the effectiveness of the market-wide circuit
breaker (``MWCB'') mechanism in Rule 11.280 from that of the Plan to
Address Extraordinary Market Volatility Pursuant to Rule 608 of
Regulation NMS (the ``LULD Plan'') and to extend the MWCB pilot's
effectiveness to the close of business on October 18, 2020. LTSE has
designated this rule change as ``non-controversial'' under Section
19(b)(3)(A) of the Act \3\ and provided the Commission with the notice
required by Rule 19b-4(f)(6) thereunder.\4\
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4.
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    The text of the proposed rule change is available at the Exchange's
website at https://longtermstockexchange.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included

statements concerning the purpose of and basis for the proposed rule
change and discussed any comments it received on the proposed rule
change. The text of these statements may be examined at the places
specified in Item IV below. The self-regulatory organization has
prepared summaries, set forth in Sections A, B, and C below, of the
most significant aspects of such statements.

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

1. Purpose
    Paragraphs (a) through (d) and (f) of Rule 11.280 describe the
methodology for determining when to halt trading in all stocks due to
extraordinary market volatility (i.e., market-wide circuit breakers).
The MWCB mechanism under Rule 11.280 was approved by the Commission to
operate on a pilot basis, the term of which was to coincide with the
pilot period for the Plan to Address Extraordinary Market Volatility
Pursuant to Rule 608 of Regulation NMS (the ``LULD Plan''),\5\
including any extensions to the pilot period for the LULD Plan. The
Commission recently approved an amendment to the LULD Plan for it to
operate on a permanent, rather than pilot, basis.\6\ The Exchange
proposes to amend Rule 11.280 to untie the pilot's effectiveness from
that of the LULD Plan and to extend the pilot's effectiveness to the
close of business on October 18, 2020. The Exchange does not propose
any additional changes to Rule 11.280, other than to move the LULD
provisions and regulatory trading halt provisions in paragraph (e), and
paragraphs (g) and (h), of Rule 11.280, respectively, to separate rules
for clarity.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012).
    \6\ See Securities Exchange Act Release No. 85623 (April 11,
2019), 84 FR 16086 (April 17, 2019) (``LULD Plan Amendment 18
Approval Order'').
---------------------------------------------------------------------------

    Specifically, the Exchange proposes to move Rule 11.280(e) (``Limit
Up-Limit Down Mechanism'') to new Rule 11.281, keep Rule 11.280(f)
within Rule 11.280 by renumbering it as Rule 11.280(e), and move Rule
11.280(g) (``Authority to Initiate Trading Halts'') and Rule 11.280(h)
(``Procedure for Initiating and Terminating a Trading Halt'') to new
Rule 11.282. Cross-references to these provisions in the LTSE
rulebook--contained in Rules 11.230, 11.350, 14.001, and 14.210, and
the supplementary material to Rule 14.207--would be updated
accordingly.
    MWCBs under Rule 11.280 provide an important, automatic mechanism
that is invoked to promote stability and investor confidence during a
period of significant stress when securities markets experience extreme
broad-based declines. All U.S. equity exchanges have rules relating to
MWCBs, which are designed to slow the effects of extreme price movement
through coordinated trading halts across securities markets when severe
price declines reach levels that may exhaust market liquidity. MWCBs
provide for trading halts in all equities and options markets during a
severe market decline as measured by a single-day decline in the S&P
500 Index.
    Pursuant to Rule 11.280, a market-wide trading halt will be
triggered if the S&P 500 Index declines in price by specified
percentages from the prior day's closing price of that index.
Currently, the triggers are set at three circuit breaker thresholds: 7%
(Level 1), 13% (Level 2) and 20% (Level 3). A market decline that
triggers a Level 1 or Level 2 circuit breaker after 9:30 a.m. ET and
before 3:25 p.m. ET would halt market-wide trading for 15 minutes,
while a similar market decline at or after 3:25 p.m. ET would not halt
market-wide trading. A market decline that triggers a Level 3 circuit
breaker, at any time during the trading day, would halt market-wide
trading for the remainder of the trading day.
    The Exchange will use the MWCB pilot extension period to develop
with the other self-regulatory organizations (``SROs'') rules and
procedures that would allow for the periodic testing of the performance
of the MWCB mechanism, with industry member participation in such
testing. The extension will also permit the SROs to consider
enhancements to the MWCB processes such as modifications to the Level 3
process.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\7\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\8\ in particular, in that it
is designed to promote just and equitable principles of trade, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general to protect
investors and the public interest.
---------------------------------------------------------------------------

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

    The MWCB mechanism under Rule 11.280 is an important, automatic
mechanism that is invoked to promote stability and investor confidence
during a period of significant stress when securities markets
experience extreme broad-based declines. Extending the MWCB pilot for
an additional year, to expire on October 18, 2020, would ensure the
continued, uninterrupted operation of a consistent mechanism to halt
trading across the U.S. markets while the Exchange, with the other
SROs, consider and develop rules and procedures that would allow for
the periodic testing of the performance of the MWCB mechanism, which
would include industry member participation in such testing. The
extension would also permit the SROs to consider enhancements to the
MWCB processes such as modifications to the Level 3 process.
    The Exchange also believes that the proposed rule change promotes
just and equitable principles of trade in that it promotes transparency
and uniformity across markets concerning when and how to halt trading
in all stocks as a result of extraordinary market volatility. Based on
the foregoing, the Exchange believes the benefits to market
participants from the MWCB under Rule 11.280 should continue on a pilot
basis because the MWCB will promote fair and orderly markets, and
protect investors and the public interest.
    Additionally, the Exchange believes that it is consistent with the
public interest and the protection of investors to move to separate
rules for clarity the LULD provisions and regulatory trading halt
provisions in Rule 11.280. Furthermore, the Exchange believes it is
consistent with the public interest and the protection of investors to
clarify that these provisions, found in paragraphs (e), (g) and (h) are
not subject to any pilot period. These clarifying changes are designed
to ensure continued compliance by the Exchange and its Members with the
requirements of the LULD Plan and to remove any ambiguity on the
ongoing applicability of the LULD Plan or other trading halt
provisions.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in the furtherance of the purposes of the Act because the proposal
would ensure the continued, uninterrupted operation of a consistent
mechanism to halt trading across the U.S. markets while the Exchange,
in conjunction with the other SROs, consider and develop rules and
procedures that would allow for the periodic testing of the performance
of the MWCB mechanism. Furthermore, as noted above, the pilot proposed
to be scheduled to expire on October 18, 2020, will permit the
exchanges to

consider enhancements to the MWCB processes such as modifications to
the Level 3 process.
    Further, the Exchange understands that FINRA and other national
securities exchanges have filed or will file proposals to extend their
rules regarding the MWCB pilot. Thus, the proposed rule change will
help to ensure consistency across market centers without implicating
any competitive issues.
    Additionally, the clarity to be provided by re-designating
paragraph (e) as a separate rule implementing the LULD provisions, and
paragraphs (g) and (h) as a separate rule providing the authority under
which the Exchange can initiate a trading halt ``in circumstances in
which LTSE deems it necessary to protect investors and the public
interest,'' and the procedures by which LTSE can both initiate and
terminate a trading halt, would not have an impact on competition.

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

    Written comments were neither solicited nor received.

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

    The Exchange has designated this rule filing as non-controversial
under Section 19(b)(3)(A) \9\ of the Act and Rule 19b-4(f)(6) \10\
thereunder. Because the proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6) thereunder.\11\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ In addition, Rule 19b-4(f)(6)(iii) requires the Exchange to
give the Commission written notice of its intent to file the
proposed rule change, along with a brief description and text of the
proposed rule change, at least five business days prior to the
filing of the proposed rule change, or such shorter time as
designated by the Commission. The Commission has waived this
requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \12\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\13\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative upon filing. Extending the pilot for an additional
year will allow the uninterrupted operation of the existing pilot to
halt trading across the U.S. markets. Therefore, the Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest. The Commission hereby
designates the proposed rule change to be operative upon filing.\14\
---------------------------------------------------------------------------

    \12\ Id.
    \13\ 17 CFR 240.19b-4(f)(6)(iii).
    \14\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-LTSE-2019-03 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-LTSE-2019-03. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
    Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly.
    All submissions should refer to File Number SR-LTSE-2019-03 and
should be submitted on or before November 14, 2019.
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    \15\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-23160 Filed 10-23-19; 8:45 am]
 BILLING CODE 8011-01-P