Denatonium Saccharide Summary Document

Registration Review: Initial Docket

June 2008

Case # 7625

Denatonium Saccharide Summary Document

Registration Review: Initial Docket

June 2008

Approved By:

___________________

								Steven Bradbury, Ph.D.

								Director, Special Review and

		       Reregistration DivisionTABLE OF CONTENTS

											Page #

Preliminary Work Plan (PWP)						4

Fact Sheet									9

Glossary of Terms and Abbreviations					12

________________________________________

Please Note

This Preliminary Work Plan and Fact Sheet summarize the Environmental
Protection Agency's current position based on the following documents:

Amended Problem Formulation for Ecological Risk Assessment for
Denatonium Saccharide.  May 2, 2008.

Denatonium Saccharide (PC code 129045). Revised Human Health Risk
Scoping Document in Support of Registration Review.  DP Barcode D352579.
 June 2, 2008.

.

Additional supporting documents for denatonium saccharide may be found
in the docket EPA-HQ-OPP-2008-0441 which may be found on the internet at
www.regulations.gov.

I. Preliminary Work Plan – Denatonium Saccharide

Introduction:

The Food Quality Protection Act of 1996 mandated a program: registration
review.  All pesticides distributed or sold in the United States
generally must be registered by the U.S. Environmental Protection Agency
(USEPA, EPA; or the Agency), based on scientific data showing that they
will not cause unreasonable risks to human health, workers, or the
environment when used as directed on product labeling.  The registration
review program is intended to make sure that, as the ability to assess
risk evolves and as policies and practices change, all registered
pesticides continue to meet the statutory standard of no unreasonable
adverse effects.  Changes in science, public policy, and pesticide use
practices will occur over time.  Through the registration review
program, the Agency periodically reevaluates pesticides to make sure
that as change occurs, products in the marketplace can be used safely.
Information on this program is provided at
http://www.epa.gov/oppsrrd1/registration_review/.

The Agency has begun to implement the registration review program, and
will review each registered pesticide every 15 years to determine
whether it continues to meet the FIFRA standard for registration.  The
public phase of registration review begins when the initial docket is
opened for each case.  The docket is the Agency’s opportunity to state
what it knows about the pesticide and what additional risk analyses and
data or information it believes are needed to make a registration review
decision.  After reviewing and responding to comments and data received
in the docket during this initial comment period, the Agency will
develop and commit to a final work plan and schedule for the
registration review of denatonium saccharide.

Denatonium Saccharide (case #7625) is a bittering agent in a squirrel,
vole, dog and cat repellant used on outdoor surfaces and structures such
as trees, fences, poles, decks, planters, siding, garbage cans,
furniture, seeds and bulbs.  For structures, it is applied as a spray or
with a paintbrush to the point of runoff.  Additionally, the product is
sprayed onto seeds and bulbs  before planting.  The largest use is for
structural pest control.

Anticipated Risk Assessment and Data Needs:

The Agency anticipates conducting a comprehensive ecological risk
assessment including an endangered species risk assessment for all
pesticide uses of denatonium saccharide.

Ecological Risk:

The Agency has not conducted a comprehensive ecological risk assessment
or an assessment that supports a complete endangered species risk
assessment determination for registered pesticide uses of denatonium
saccharide.  Please see Amended Problem Formulation for Ecological Risk
Assessment for Denatonium Saccharide for a detailed discussion of the
anticipated risk assessment needs.

The Agency anticipates needing the following data in order to conduct a
complete ecological risk assessment for the uses of denatonium
saccharide, including an endangered species assessment:

(GLN 835.2120) Hydrolysis of parent and degradates as a function of pH
at 25 C

(GLN 835.4100) Aerobic soil metabolism

(GLN 835.1230) Sediment and soil adsorption/desorption for parent and
degradates

(GLN 850.2100) Avian acute oral toxicity test

(GLN 850.2200) Avian dietary toxicity test

(GLN 850.1010) Aquatic invertebrate acute toxicity test, freshwater
daphnids, and

(GLN 850.1075) Freshwater fish acute toxicity test.

The planned ecological risk assessment will allow the Agency to
determine if denatonium saccharide’s use has “no effect” or “may
affect” federally listed threatened or endangered species (listed
species) or their designated critical habitat.  If the screening level
assessment indicates that denatonium saccharide “may affect” a
listed species or its designated critical habitat, the assessment will
be refined.  The refined assessment will allow the Agency to determine
whether use of denatonium saccharide is “likely to adversely affect”
the species or critical habitat or "not likely to adversely affect" the
species or critical habitat.  When an assessment concludes that a
pesticide's use “may affect” a listed species or its designated
critical habitat, the Agency will consult with the U.S. Fish and
Wildlife Service and/or National Marine Fisheries Service (the
Services), as appropriate.

Human Health Risk:

Acute oral, dermal, and inhalation toxicities for the formulated product
of denatonium saccharide are low  (category IV).  Denatonium saccharide
is not an eye irritant, skin irritant or a skin sensitizor.  No
subchronic or chronic toxicity studies are available for denatonium
saccharide.

No dietary exposure assessment was conducted previously.   There are no
food uses for denatonium saccharide, and contamination of homegrown
produce from residential use is unlikely.  The Agency has not conducted
a drinking water assessment for denatonium saccharide; however,
depending on the outcome of the Agency’s drinking water exposure
assessment, a chronic dietary assessment for drinking water exposure may
be needed.  The Agency does not believe that there are acute dietary
risks of concern because denatonium saccharide is a bitter compound that
is unlikely to be consumed by humans in large enough quantities to
produce acute toxic effects.

No residential exposure assessment was conducted previously.  Exposures
to residential handlers during application can occur, especially dermal
exposure.  Therefore, a dermal absorption study on the active ingredient
is needed.  A dermal residential handler dermal assessment may be
necessary if denatonium saccharide is dermally absorbed.

If results from environmental fate studies, requested in this document,
predict drinking water concerns, an aggregate risk assessment may be
needed

No occupational risk assessment was conducted previously.  However, no
assessment is needed at this time because of denatonium saccharide’s
low acute toxicity of the formulation, the required personal protective
equipment stated on the product label, and the fact that no incidents
have been reported so far.  However, if denatonium saccharide is found
to be dermally absorbed, an occupational risk assessment may be needed.

The Agency anticipates needing the following data in order to conduct a
complete human health risk assessment for the uses of denatonium
saccharide:

(GLN 870.3200) 21 day dermal absorption study, and

(GLN 870.3100) 90 day oral toxicity study – rodent.

Please refer to Denatonium Saccharide (PC code 129045) Revised Human
Health Risk Scoping Document in Support of Registration Review for more
information regarding the human health effects of denatonium saccharide

Timeline:

EPA has created the following estimated timeline for the completion of
the denatonium saccharide registration review.

Registration Review for denatonium saccharide

Projected Registration Review Timeline

Activities 	Estimated Month/Year

Phase 1: Opening the docket

Open Public Comment Period for denatonium saccharide Docket  	2008 –
Jun.

Close Public Comment Period 	2008 – Sept.

Phase 2:  Case Development

Develop Final Work Plan (FWP)	2008 – Nov.

Issue DCI	2009 –Jul. – Sept.

Data Submission	2011 – Oct. – Dec.

Open Public Comment Period for Preliminary Risk Assessments 	2013 –
Apr. – Jun.

Close Public Comment Period	2013 – Jul. – Sept.

Phase 3: Registration Review Decision

Open Public Comment Period for Proposed Reg. Review Decision 	2013 –
Oct. – Dec.

Close Public Comment Period 	2014 – Jan.—Mar.

Final Decision and Begin Post-Decision Follow-up	2014 – Jul. – Sept.

Total (years)	6

Guidance for Commenters:

The public is invited to comment on EPA’s preliminary registration
review work plan and rationale.  The Agency will carefully consider all
comments as well as any additional information or data provided prior to
issuing a final work plan for the denatonium saccharide case.

Denatonium saccharide is not identified as a cause of impairment for any
water bodies listed as impaired under section 303(d) of the Clean Water
Act, based on information provided at
http://oaspub.epa.gov/tmdl/waters_list.impairments?p_impid=3.  The
Agency invites submission of water quality data for this pesticide.  To
the extent possible, data should conform to the quality standards in
Appendix A of the OPP Standard Operating Procedure: Inclusion of
Impaired Water Body and Other Water Quality Data in OPP’s Registration
Review Risk Assessment and Management Process (see:   HYPERLINK
"http://www.epa.gov/oppfead1/cb/ppdc/2006/november06/session1-sop.pdf"
http://www.epa.gov/oppfead1/cb/ppdc/2006/november06/session1-sop.pdf ),
in order to ensure they can be used quantitatively or qualitatively in
pesticide risk assessments.

EPA seeks to achieve environmental justice, the fair treatment and
meaningful involvement of all people, regardless of race, color,
national origin, or income, in the development, implementation, and
enforcement of environmental laws, regulations, and policies. To help
address potential environmental justice issues, the Agency seeks
information on any groups or segments of the population who, as a result
of their location, cultural practices, or other factors, may have
atypical, unusually high exposure to denatonium saccharide compared to
the general population. Please comment if you are aware of any
sub-populations that may have atypical, unusually high exposure compared
to the general population.

Stakeholders are also specifically asked to provide information and data
that will assist the Agency in refining the ecological risk assessment,
including any species-specific effects determinations.  The Agency is
interested in obtaining the following information regarding the use of
denatonium saccharide:

confirmation on the following label information

sites of application

formulations

application methods and equipment

maximum application rate

frequency of application, application intervals, and maximum number of
applications per year

geographic limitations on use

use history

sub-county location data

typical interval (days)

state or local use restrictions

ecological incidents (non-target plant damage and avian, fish,
reptilian, amphibian and mammalian mortalities) not already reported to
the Agency

monitoring data

Next Steps:

After the comment period closes, the Agency will review any comments
received, and then issue a Final Work Plan for this pesticide.

II. FACT SHEET

Background Information:

Denatonium saccharide is a squirrel, vole, dog and cat repellant used on
outdoor surfaces and structures.

Registration Review case number: 7625

PC code: 129045		CAS #: 90823-38-4

No technical registrant

Special Review and Reregistration Division (SRRD), Chemical Review
Manager (CRM): Joy Schnackenbeck<EMAIL_ADDRESS>
Registration Division (RD) Contact: Dan Peacock<EMAIL_ADDRESS>
One active product

Use Information:

Usage data for denatonium saccharide is extremely limited.

Denatonium saccharide is sold as a ready to use liquid.

Denatonium saccharide is applied with a sprayer or paintbrush.

Limited denatonium saccharide usage information is only available for
the State of California.

Denatonium saccharide’s use is primarily residential.

Ecological Risk Assessment Status:

The following ecological outcomes are anticipated based on limited data
and risk assessments currently available.  Please refer to Amended
Problem Formulation for Ecological Risk Assessment for Denatonium
Saccharide for a detailed discussion of the anticipated ecological risk
assessment needs.  A summary follows.

No previous ecological assessment has been completed for denatonium
saccharide.

No environmental fate data have been submitted; the fate of denatonium
saccharide in the environment remains unknown.

Acute effects of denatonium saccharide to mammals and terrestrial plants
are unlikely because mammalian toxicity is low, and exposure of
terrestrial plants will be minimal.

Acute effects of denatonium saccharide to birds and aquatic organisms
exposed are unknown.  Birds may eat treated seeds without being deterred
since the product is not labeled as a bird deterrent.  Additionally,
aquatic organisms may be subjected to denatonium saccharide by ingestion
of seeds that have washed into aquatic systems and denatonium saccharide
that may wash off seeds once they are submerged.

Before the risk assessments are developed for public comment, the Agency
will

ensure that all currently registered uses of denatonium saccharide have
an endangered species assessment completed.  The ecological risk
assessment will allow the Agency to determine whether denatonium
saccharide use has "no effect" or "may affect" federally listed
threatened or endangered species (listed species) or their designated
critical habitat.  If the assessment concludes that a pesticide's use
"may affect" a listed species or its designated critical habitat, the
Agency will consult with the U.S. Fish and Wildlife Service and/or
National Marine Fisheries Service (Services), as appropriate.

Human Health Risk Assessment Status:

Please refer to Denatonium Saccharide (PC code 129045) Revised Human
Health Risk Scoping Document in Support of Registration Review for a
detailed discussion of the anticipated risk assessment needs for human
health.  A summary follows.

Dietary (Food and Water):

There are no food uses for denatonium saccharide and contamination of
homegrown produce from residential use of denatonium saccharide is
unlikely.

Dietary exposure from drinking water is unknown.  A dietary assessment
for drinking water exposure may be performed as part of the registration
review of denatonium saccharide.

Residential:

Exposures to residential handlers during application may occur through
dermal exposure.  A dermal residential handler assessment may be
necessary if denatonium saccharide is found to be dermally absorbed.

Occupational:

Occupational exposure is unlikely because of the product’s low
acute-toxicity, the required personal protective equipment, and the
predominately-residential use pattern.  However, if denatonium
saccharide is found to be dermally absorbed, an occupational risk
assessment may be needed.

Aggregate:

Denatonium saccharide is a non-food use chemical, however dietary
exposure from drinking water is unknown at this time; therefore, an
aggregate assessment may be needed.

Incident Reports:

No cases have been reported in OPP’s Incident Data System (IDS) from
1999 to present.

Tolerances:

Denatonium saccharide has no food uses; therefore, it has no associated
tolerances.

Data Call-In Status:

There are no current data call-ins.

Labels:

Denatonium saccharide is only associated with one registration:
registration number 81117-1, Ro-pel Tree Squirrel, vole, Dog and Cat
Repellent.  Its label can be obtained from the Pesticide Product Label
System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home.

III. GLOSSARY of TERMS and ABBREVIATIONS

ai		Active Ingredient

AR		Anticipated Residue

CFR		Code of Federal Regulations

cPAD		Chronic Population Adjusted Dose

CSF		Confidential Statement of Formula

CSFII		USDA Continuing Surveys for Food Intake by Individuals

DCI		Data Call-In

DEEM		Dietary Exposure Evaluation Model

DFR		Dislodgeable Foliar Residue

DNT		Developmental Neurotoxicity

DWLOC		Drinking Water Level of Comparison

EC		Emulsifiable Concentrate Formulation

EDWC		Estimated Drinking Water Concentration

EEC		Estimated Environmental Concentration

EPA			Environmental Protection Agency

EUP		End-Use Product

FDA		Food and Drug Administration

FIFRA		Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA		Federal Food, Drug, and Cosmetic Act

FQPA		Food Quality Protection Act

FOB		Functional Observation Battery

GENEEC		Tier I Surface Water Computer Model

IR		Index Reservoir

LC50	Median Lethal Concentration.  A statistically derived concentration
of a substance that can be expected to cause death in 50% of test
animals.  It is usually expressed as the weight of substance per weight
or volume of water, air or feed, e.g., mg/l, mg/kg or ppm.

LD50	Median Lethal Dose.  A statistically derived single dose that can
be expected to cause death in 50% of the test animals when administered
by the route indicated (oral, dermal, inhalation).  It is expressed as a
weight of substance per unit weight of animal, e.g., mg/kg.

LOC		Level of Concern

LOAEL		Lowest Observed Adverse Effect Level

µg/g		Micrograms Per Gram

µg/L		Micrograms Per Liter

mg/kg/day		Milligram Per Kilogram Per Day

mg/L		Milligrams Per Liter

MOE		Margin of Exposure

MRID	Master Record Identification (number).  EPA's system of recording
and tracking submitted studies.

MUP		Manufacturing-Use Product

NA		Not Applicable

NAWQA		USGS National Ambient Water Quality Assessment

NPDES		National Pollutant Discharge Elimination System

NR		Not Required

NOAEL		No Observed Adverse Effect Level

OPP		EPA Office of Pesticide Programs

OPPTS		EPA Office of Prevention, Pesticides and Toxic Substances

PAD		Population Adjusted Dose

PCA		Percent Crop Area

PDP		USDA Pesticide Data Program

PHED		Pesticide Handler's Exposure Data

PHI			Preharvest Interval

ppb		Parts Per Billion

PPE		Personal Protective Equipment

ppm		Parts Per Million

PRZM/EXAMS		Tier II Surface Water Computer Model

Q1*	The Carcinogenic Potential of a Compound, Quantified by the EPA's
Cancer Risk Model

RAC		Raw Agriculture Commodity

RED		Reregistration Eligibility Decision

REI		Restricted Entry Interval

RfD		Reference Dose

RQ		Risk Quotient

SCI-GROW		Tier I Ground Water Computer Model

SAP		Science Advisory Panel

SF		Safety Factor

SLN		Special Local Need  (Registrations Under Section 24©) of FIFRA)

TGAI		Technical Grade Active Ingredient

USDA		United States Department of Agriculture

UF		Uncertainty Factor

WPS		Worker Protection Standard

Docket Number: EPA-HQ-OPP-2008-0441

www.regulations.gov

 PAGE

 PAGE   9

Docket Number: EPA-HQ-OPP-2008-0441

www.regulations.gov


[Federal Register: September 16, 2009 (Volume 74, Number 178)]
[Rules and Regulations]
[Page 47435]
[DOCID:fr16se09-1]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 101

[Docket No. FAA-2007-27390; Amendment No. 101-8]
RIN 2120-AI88

Requirements for Amateur Rocket Activities

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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

SUMMARY: The FAA is making an editorial change to the amateur rocket
regulations. This action corrects an unintentional error in the
difference between statute and nautical miles. The intent is to ensure
the regulations are clear and accurate.

DATES: This amendment is effective September 16, 2009.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this final rule, contact Charles P. Brinkman, Licensing and Safety
Division (AST-200), Commercial Space Transportation, Federal Aviation
Administration, 800 Independence Avenue, Washington, DC 20591,
telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>For legal
questions concerning this final rule, contact Gary Michel, Office of
the Chief Counsel, Federal Aviation Administration, 800 Independence
Avenue, Washington, DC 20591, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On Friday, July 31, 2009 (74 FR 38092), the FAA published a
technical amendment to the final rule ``Requirements for Amateur Rocket
Activities.'' The final rule was published on December 4, 2008 (73 FR
73768). During the review process, we determined that an additional
minor amendment is needed in part 101.
    In the first line of Sec.  101.25(e), the number ``8'' (kilometers)
is changed to ``9.26'' to correct the metric conversion when the word
``statute'' is replaced with the word ``nautical''.

Technical Correction

    This technical correction merely ensures correct placement of
miscellaneous words. There are no other changes to the existing
regulatory text.

Justification for Immediate Adoption

    Because this action is editorial, the FAA finds that notice and
public comment under 5 U.S.C. section 553(b) is unnecessary. For the
same reason, the FAA finds good cause exists under 5 U.S.C. section
553(d) for making this rule effective upon publication.

List of Subjects for 14 CFR Part 101

    Aircraft, Aviation safety.

The Amendment

0
In consideration of the foregoing, the FAA amends 14 CFR part 101, as
follows:

PART 101--MOORED BALLOONS, KITES, UNMANNED ROCKETS AND UNMANNED
FREE BALLOONS

0
1. The authority citation for part 101 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113-40114, 45302, 44502,
44514, 44701-44702, 44721, 46308.

Sec.  101.25  [Amended]

0
2. Amend Sec.  101.25(e) by removing the number ``8'' and adding the
number ``9.26'' in its place and removing the word ``statute'' and
adding the word ``nautical'' in its place.

    Issued in Washington, DC, on September 10, 2009.
Brenda D. Courtney,
Acting Director, Office of Rulemaking.
[FR Doc. E9-22341 Filed 9-15-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52152-52155]
[FR Doc No: 2019-21246]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87108; File No. SR-CboeBZX-2019-067]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Order
Granting Approval of a Proposed Rule Change, as Modified by Amendment
Nos. 2 and 3, to List and Trade Shares of the Innovator-100 Buffer ETF
Series, Innovator Russell 2000 Buffer ETF Series, Innovator-100 Power
Buffer ETF Series, Innovator Russell 2000 Power Buffer ETF Series,
Innovator-100 Ultra Buffer ETF Series, and Innovator Russell 2000 Ultra
Buffer ETF Series Under Rule 14.11(i)

September 25, 2019.

I. Introduction

    On July 18, 2019, Cboe BZX Exchange, Inc. (``Exchange'' or ``BZX'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
list and trade the shares (``Shares'') of the Innovator-100 Buffer ETF
Series and Innovator Russell 2000 Buffer ETF Series (collectively, the
``Buffer Funds''), Innovator-100 Power Buffer ETF Series and Innovator
Russell 2000 Power Buffer ETF Series (collectively, the ``Power Buffer
Funds''), and Innovator-100 Ultra Buffer ETF Series and Innovator
Russell 2000 Ultra Buffer ETF Series (collectively, the ``Ultra Buffer
Funds,'' and together with the Buffer Funds and Power Buffer Funds, the
``Funds'') under BZX Rule 14.11(i). The proposed rule change was
published for comment in the Federal Register on August 5, 2019.\3\ On
August 29, 2019, the Exchange filed Amendment No. 1 to the proposed
rule change. On September 17, 2019, the Commission extended the time
period within which to approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
approve or disapprove the proposed rule change.\4\ On September 19,
2019, the Exchange filed Amendment No. 2 to the proposed rule change,
which amended and superseded the proposed rule change as modified by
Amendment No. 1.\5\ On September 24, 2019, the Exchange filed partial
Amendment No. 3 to the proposed rule change.\6\ The Commission has
received no comments on the proposed rule change. This order approves
the proposed rule change, as modified by Amendment Nos. 2 and 3.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 86511 (July 30,
2019), 84 FR 38078.
    \4\ See Securities Exchange Act Release No. 86996, 84 FR 49779
(September 23, 2019) (extending the time period to November 3,
2019).
    \5\ In Amendment No. 2, the Exchange: (1) Deleted its
representation about the index provider implementing and maintaining
a firewall; (2) modified the downside protection in the Buffer Funds
from 10% to 9%; (3) clarified descriptions about the investment
methodology of the Funds; (4) modified descriptive terms on the
liquidity and competitive market for options on the reference
indexes; (5) identified options exchanges trading standardized and
FLexible EXchange Options (``FLEX Options'') on the reference
indexes (6) updated volume information on standardized options in
the reference indexes; and (7) made other technical, non-substantive
changes.
    \6\ The amendments to the proposed rule change are available at:
https://www.sec.gov/comments/sr-cboebzx-2019-067/srcboebzx2019067.htm. In partial Amendment No. 3, the Exchange
clarified a description related to the Buffer Funds. Because
Amendment Nos. 2 and 3 do not materially alter the substance of the
proposed rule change or raise unique or novel regulatory issues,
Amendment Nos. 2 and 3 are not subject to notice and comment.
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change, as Modified by Amendment
Nos. 2 and 3

    The Exchange proposes to list and trade the Shares under BZX Rule
14.11(i), which governs the listing and trading of Managed Fund Shares
on the Exchange. In total, the Exchange is proposing to list and trade
Shares of up to twelve monthly series of each of the Funds. The Shares
will be offered by Innovator ETFs Trust (``Trust''), a Delaware
statutory trust.\7\ The

investment adviser to the Funds is Innovator Capital Management, LLC
(``Adviser''), and the sub-adviser to the Funds is Milliman Financial
Risk Management LLC (``Sub-Adviser'').
---------------------------------------------------------------------------

    \7\ The Trust is registered with the Commission as an investment
company and has filed a registration statement for each Fund with
the Commission on Form N-1A (File Nos. 333-146827 and 811-22135)
(``Registration Statement'') under the Securities Act of 1933 (15
U.S.C. 77a), dated February 6, 2019. According to the Exchange, the
description of the operation of the Funds and the Shares herein is
based, in part, on the Registration Statement.
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    The investment objective of the Funds is to provide investors with
returns that match those of the Nasdaq-100 Index (the ``Nasdaq-100
Price Index'') or the Russell 2000 Price Index (the ``Russell 2000
Price Index'') (collectively, the ``Reference Indexes'') over a period
of approximately one year, while providing a level of protection from
losses in the applicable Reference Index.

A. Buffer Funds

    The Buffer Funds are actively managed funds that seek to provide
investment returns that match the gains of the applicable Reference
Index, up to a maximized annual return (the ``Buffer Cap Level''),\8\
while guarding against a decline in the Reference Index for the first
9%. Specifically, the Buffer Fund is designed to provide the following
results during the outcome period:
---------------------------------------------------------------------------

    \8\ The Exchange states that the Buffer Cap Level will be
determined with respect to each Buffer Fund on the inception date of
the Buffer Fund and at the beginning of each outcome period. See
Amendment No. 2, supra note 5, at 10-11.
---------------------------------------------------------------------------

     If the Reference Index appreciates over the outcome
period: The Buffer Fund is designed to provide a total return that
matches the total return of the applicable Reference Index, up to the
applicable Buffer Cap Level;
     If the Reference Index decreases over the outcome period
by 9% or less: The Buffer Fund is designed to provide a total return of
zero; and
     If the Reference Index depreciates over the outcome period
by greater than 9%: The Buffer Fund is designed to provide a total
return loss that is 9% less than the percentage loss on the Reference
Index with a maximum loss of approximately 91%.\9\
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    \9\ The Exchange states that the Buffer Funds do not offer any
protection against declines in the Reference Index exceeding 9% on
an annualized basis. See id. at 10. Shareholders will bear all
Reference Index losses exceeding 9% on a one-to-one basis. See id.
---------------------------------------------------------------------------

    The Buffer Fund is designed to produce these outcomes by including
theoretically ``purchased'' and ``written'' FLEX Options that, when
layered upon each other, are designed to buffer against losses of the
applicable Reference Index and cap the level of possible gains.
    Under Normal Market Conditions,\10\ each Buffer Fund will attempt
to achieve its investment objective by taking positions that provide
performance exposure that match the gains of the applicable Reference
Index. Each Buffer Fund will invest primarily in exchange-traded
options contracts that reference either the Reference Index or exchange
traded funds (``ETFs'') that track the Reference Index.\11\ Any FLEX
Options written by a Buffer Fund that create an obligation to sell or
buy an asset will be offset with a position in FLEX Options purchased
by the Buffer Fund to create the right to buy or sell the same asset
such that the Buffer Fund will always be in a net long position. As the
FLEX Options mature at the end of each outcome period, they are
replaced.
---------------------------------------------------------------------------

    \10\ As defined in BZX Rule 14.11(i)(3)(E), the term ``Normal
Market Conditions'' includes, but is not limited to, the absence of
trading halts in the applicable financial markets generally;
operational issues causing dissemination of inaccurate market
information or system failures; or force majeure type events such as
natural or man-made disaster, act of God, armed conflict, act of
terrorism, riot or labor disruption, or any similar intervening
circumstance.
    \11\ The FLEX Options owned by each of the Buffer Funds will
have the same terms (i.e., same strike price and expiration) for all
investors of a Buffer Fund within an outcome period. See Amendment
No. 2, supra note 5, at 10.
---------------------------------------------------------------------------

B. Power Buffer Funds

    The Power Buffer Funds are actively managed funds that seek to
provide investment returns that match the gains of the applicable
Reference Index, up to a maximized annual return (the ``Power Buffer
Cap Level''),\12\ while guarding against a decline in the Reference
Index for the first 15%. Specifically, the Power Buffer Fund is
designed to provide the following results during the outcome period:
---------------------------------------------------------------------------

    \12\ The Exchange states that the Power Buffer Cap Level will be
determined with respect to each Power Buffer Fund on the inception
date of the Power Buffer Fund and at the beginning of each outcome
period. See Amendment No. 2, supra note 5, at 12-13.
---------------------------------------------------------------------------

     If the Reference Index appreciates over the outcome
period: The Power Buffer Fund is designed to provide a total return
that matches the total return of the applicable Reference Index, up to
the applicable Power Buffer Cap Level;
     If the Reference Index decreases over the outcome period
by 15% or less: The Power Buffer Fund is designed to provide a total
return of zero; and
     If the Reference Index depreciates over the outcome period
by greater than 15%: The Power Buffer Fund is designed to provide a
total return loss that is 15% less than the percentage loss on the
Reference Index with a maximum loss of approximately 85%.\13\
---------------------------------------------------------------------------

    \13\ The Exchange states that the Power Buffer Funds do not
offer any protection against declines in the Reference Index
exceeding 15% on an annualized basis. See id. at 12. Shareholders
will bear all Reference Index losses exceeding 15% on a one-to-one
basis. See id.
---------------------------------------------------------------------------

    The Power Buffer Fund is designed to produce these outcomes by
including theoretically ``purchased'' and ``written'' FLEX Options
that, when layered upon each other, are designed to buffer against
losses of the applicable Reference Index and cap the level of possible
gains.
    Under Normal Market Conditions, each Power Buffer Fund will attempt
to achieve its investment objective by taking positions that provide
performance exposure that match the gains of the applicable Reference
Index. Each Power Buffer Fund will invest primarily in exchange-traded
options contracts that reference either the Reference Index or ETFs
that track the Reference Index.\14\ Any FLEX Options written by a Power
Buffer Fund that create an obligation to sell or buy an asset will be
offset with a position in FLEX Options purchased by the Power Buffer
Fund to create the right to buy or sell the same asset such that the
Power Buffer Fund will always be in a net long position. As the FLEX
Options mature at the end of each outcome period, they are replaced.
---------------------------------------------------------------------------

    \14\ The FLEX Options owned by each of the Power Buffer Funds
will have the same terms (i.e., same strike price and expiration)
for all investors of a Power Buffer Fund within an outcome period.
See id.
---------------------------------------------------------------------------

C. Ultra Buffer Funds

    The Ultra Buffer Funds are actively managed funds that seek to
provide investment returns that match the gains of the applicable
Reference Index, up to a maximized annual return (the ``Ultra Buffer
Cap Level''),\15\ while guarding against a decline in the Reference
Index of between 5% and 35%. Specifically, the Ultra Buffer Fund is
designed to provide the following results during the outcome period:
---------------------------------------------------------------------------

    \15\ The Exchange states that the Ultra Buffer Cap Level will be
determined with respect to each Ultra Buffer Fund on the inception
date of the Ultra Buffer Fund and at the beginning of each outcome
period. See Amendment No. 2, supra note 5, at 12-13.
---------------------------------------------------------------------------

     If the Reference Index appreciates over the outcome
period: The Ultra Buffer Fund is designed to provide a total return
that matches the total return of the applicable Reference Index, up to
the applicable Ultra Buffer Cap Level;
     If the Reference Index decreases over the outcome period
by 5% or less: The Ultra Buffer Fund is designed to provide a total
return loss that is equal

to the percentage loss on the Reference Index;
     If the Reference Index depreciates over the outcome period
by 5%-35%: The Ultra Buffer Fund is designed to provide a total return
loss of 5%; and
     If the Reference Index depreciates over the outcome period
by more than 35%: The Ultra Buffer Fund is designed to provide a total
return loss that is 30% less than the percentage loss on the Reference
Index with a maximum loss of approximately 70%.\16\
---------------------------------------------------------------------------

    \16\ The Exchange states that the Ultra Buffer Funds do not
offer any protection against declines in the Reference Index
exceeding 35% on an annualized basis. See id. at 14. Shareholders
will bear all Reference Index losses exceeding 35% on a one-to-one
basis. See id.
---------------------------------------------------------------------------

    The Ultra Buffer Fund is designed to produce these outcomes by
including theoretically ``purchased'' and ``written'' FLEX Options
that, when layered upon each other, are designed to buffer against
losses of the applicable Reference Index and cap the level of possible
gains.
    Under Normal Market Conditions, each Ultra Buffer Fund will attempt
to achieve its investment objective by taking positions that provide
performance exposure that match the gains of the applicable Reference
Index. Each Ultra Buffer Fund will invest primarily in exchange-traded
options contracts that reference either the Reference Index or ETFs
that track the Reference Index.\17\ Any FLEX Options written by a Ultra
Buffer Fund that create an obligation to sell or buy an asset will be
offset with a position in FLEX Options purchased by the Ultra Buffer
Fund to create the right to buy or sell the same asset such that the
Ultra Buffer Fund will always be in a net long position. As the FLEX
Options mature at the end of each outcome period, they are replaced.
---------------------------------------------------------------------------

    \17\ The FLEX Options owned by each of the Ultra Buffer Funds
will have the same terms (i.e., same strike price and expiration)
for all investors of an Ultra Buffer Fund within an outcome period.
See id. at 15.
---------------------------------------------------------------------------

D. Investment Methodology for the Funds

    As mentioned above, under Normal Market Conditions, each Fund would
seek to achieve its respective investment objective by investing
primarily in exchange-traded options contracts that reference either
the Reference Index or ETFs that track the Reference Index. Each of the
Funds might invest its net assets (in the aggregate) in other
investments which the Adviser or Sub-Adviser believes would help each
Fund meet its investment objective and that would be disclosed at the
end of each trading day (``Other Assets'').\18\
---------------------------------------------------------------------------

    \18\ Other Assets include only cash or cash equivalents, as
defined in BZX Rule 14.11(i)(4)(C)(iii), and standardized options
contracts listed on a U.S. securities exchange that reference either
the Reference Index or that reference ETFs that track the Reference
Index (``Reference ETFs''). As defined in BZX Rule
14.11(i)(4)(C)(iii), cash equivalents include short-term instruments
with maturities of less than three months, including: (i) U.S.
Government securities, including bills, notes, and bonds differing
as to maturity and rates of interest, which are either issued or
guaranteed by the U.S. Treasury or by U.S. Government agencies or
instrumentalities; (ii) certificates of deposit issued against funds
deposited in a bank or savings and loan association; (iii) bankers
acceptances, which are short-term credit instruments used to finance
commercial transactions; (iv) repurchase agreements and reverse
repurchase agreements; (v) bank time deposits, which are monies kept
on deposit with banks or savings and loan associations for a stated
period of time at a fixed rate of interest; (vi) commercial paper,
which are short-term unsecured promissory notes; and (vii) money
market funds.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    After careful review, the Commission finds that the Exchange's
proposal to list and trade the Shares is consistent with the Act and
the rules and regulations thereunder applicable to a national
securities exchange.\19\ In particular, the Commission finds that the
proposed rule change, as modified by Amendment Nos. 2 and 3, is
consistent with Section 6(b)(5) of the Act,\20\ which requires, among
other things, that the Exchange's rules be 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. The
Commission also finds that the proposal to list and trade the Shares on
the Exchange is consistent with Section 11A(a)(1)(C)(iii) of the
Act,\21\ which sets forth Congress' finding that it is in the public
interest and appropriate for the protection of investors and the
maintenance of fair and orderly markets to assure the availability to
brokers, dealers and investors of information with respect to
quotations for and transactions in securities.
---------------------------------------------------------------------------

    \19\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \20\ 15 U.S.C. 78f(b)(5).
    \21\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
---------------------------------------------------------------------------

    According to the Exchange, quotation and last-sale information for
U.S. exchange-listed options contracts cleared by The Options Clearing
Corporation will be available via the Options Price Reporting
Authority.\22\ RFQ information for FLEX Options will be available
directly from the applicable options exchange. The intra-day, closing
and settlement prices of exchange-traded options will be readily
available from the options exchanges, automated quotation systems,
published or other public sources, or online information services.\23\
In addition, price information about cash equivalents will be available
from major broker-dealer firms or market data vendors, as well as from
automated quotation systems, published or other public sources, or
online information services.\24\
---------------------------------------------------------------------------

    \22\ See Amendment No. 2, supra note 5, at 21.
    \23\ See id.
    \24\ See id.
---------------------------------------------------------------------------

    The Commission also believes that the proposal to list and trade
the Shares is reasonably designed to promote fair disclosure of
information that may be necessary to price the Shares appropriately and
to prevent trading when a reasonable degree of transparency cannot be
assured. Under BZX Rule 14.11(i)(4)(B)(iv), if the Exchange becomes
aware that the Net Asset Value (``NAV'') or the Disclosed Portfolio is
not disseminated to all market participants at the same time, the
Exchange is required to halt trading in such series of Managed Fund
Shares. In addition, the Exchange represents that if the Funds or the
Shares are not in compliance with the applicable listing requirements
for Managed Funds Shares under BZX Rule 14.11(i), the Exchange will
commence delisting procedures under BZX Rule 14.12 (Failure to Meet
Listing Standards).\25\ The Exchange also states that it has a general
policy prohibiting the distribution of material, non-public information
by its employees.\26\ Further, the Trust has represented that it will
provide and maintain a publicly available tool on its website that will
provide existing and prospective Fund shareholders with certain
information for each of the Funds including, among other things,
current NAV, start and end dates of the current outcome period, and the
remaining buffer available for a shareholder purchasing Shares at the
current NAV or the amount of losses that a shareholder purchasing
Shares at the current NAV would incur before benefitting from the
protection of the buffer.\27\
---------------------------------------------------------------------------

    \25\ See id. at 25.
    \26\ See id.
    \27\ See id. at 22.
---------------------------------------------------------------------------

    The Shares do not qualify for generic listing because the Funds
will not satisfy the requirement of BZX Rule 14.11(i)(4)(C)(iv)(b) that
the aggregate gross notional value of listed derivatives based on any
five or fewer underlying reference assets shall not exceed 65% of

the weight of the portfolio and the aggregate gross notional value of
listed derivatives based on any single underlying reference asset not
exceed 30% of the weight of the portfolio (including gross notional
exposures). Instead, the Funds will hold listed derivatives primarily
on a single reference asset, the Nasdaq-100 Index or the Russell 2000
Price Index.\28\ Despite the exposure of the listed derivatives to a
single reference asset, the Commission nevertheless believes that
certain representations by the Exchange help to mitigate concerns about
the prices of the Shares being susceptible to manipulation.
Specifically, the Exchange represents that the market for options
contracts for each Reference Index are liquid and derive their value
from actively traded Reference Index components. Additionally, all of
the options held by the Funds will trade on markets that are a member
of ISG or affiliated with a member of ISG or with which the Exchange
has in place a comprehensive surveillance sharing agreement.\29\
---------------------------------------------------------------------------

    \28\ The Funds also may invest in options overlying Reference
ETFs. See id. at 15. The Exchange states that each of the applicable
Reference Indexes meet the generic listing standards applicable to
indexes underlying series of Index Fund Shares listed on the
Exchange, which include diversity, liquidity, and market cap
requirements that are designed to ensure that an underlying index is
not susceptible to manipulation. See id. at 17, n.14.
    \29\ For a list of the current members of ISG, see
www.isgportal.org.
---------------------------------------------------------------------------

    Additionally, in support of this proposal, the Exchange represents
that:
    (1) The Funds and the Shares will satisfy all of the requirements
applicable to Managed Fund Shares under BZX Rule 14.11(i), as well as
the Generic Listing Standards other than BZX Rule
14.11(i)(4)(C)(iv)(b).
    (2) Trading in the Shares will be subject to the existing trading
surveillances administered by the Exchange, as well as cross-market
surveillances administered by FINRA, on behalf of the Exchange, which
are designed to detect violations of Exchange rules and applicable
federal securities laws.
    (3) For initial and continued listing, the Funds will be in
compliance with Rule 10A-3 under the Act.\30\
---------------------------------------------------------------------------

    \30\ 17 CFR 240.10A-3.
---------------------------------------------------------------------------

    (4) A minimum of 100,000 Shares will be outstanding at the
commencement of trading on the Exchange.\31\
---------------------------------------------------------------------------

    \31\ See Amendment No. 2, supra note 5, at 20.
---------------------------------------------------------------------------

    This approval order is based on all of the Exchange's statements
and representations, including those set forth above and in Amendment
Nos. 2 and 3.
    For the foregoing reasons, the Commission finds that the proposed
rule change, as modified by Amendment Nos. 2 and 3 thereto, is
consistent with Section 6(b)(5) of the Act \32\ and the rules and
regulations thereunder applicable to a national securities exchange.
---------------------------------------------------------------------------

    \32\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\33\ that the proposed rule change (SR-CboeBZX-2019-067), as
modified by Amendment Nos. 2 and 3, be, and it hereby is, approved.
---------------------------------------------------------------------------

    \33\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\34\
---------------------------------------------------------------------------

    \34\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-21246 Filed 9-30-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 28 (Thursday, February 10, 2011)]
[Notices]
[Pages 7623-7625]
[FR Doc No: 2011-2985]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2010-0022]

Parts and Accessories Necessary for Safe Operation; Brakes;
Application for Exemption From Innovative Electronics

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of application for exemption; request for comments.

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

SUMMARY: FMCSA requests public comment on an application for exemption
from Innovative Electronics regarding the use of trailer-mounted
electric brake controllers, which monitor and actuate trailer brakes
based on inertial forces developed in response to the braking action of
the towing vehicle. While trailer-mounted electric brake controllers
function like an electric surge brake, the Federal Motor Carrier Safety
Regulations (FMCSRs) define a surge brake as a ``self-contained,
permanently closed hydraulic brake system'' [Emphasis added.] As such,
the use of trailer-mounted electric brake controllers on commercial
motor vehicles is currently prohibited. Innovative Electronics is
requesting a temporary exemption in advance of petitioning FMCSA for
rulemaking to

modify the current definition of a surge brake.

DATES: Comments must be received on or before March 14, 2011.

ADDRESSES: You may submit comments identified by DOT DMS Docket Number
FMCSA-2010-0022 by any of the following methods:
     Web site: http://www.regulations.gov. Follow the
instructions for submitting comments on the Federal electronic docket
site.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility, U.S. Department of
Transportation, Room W12-140, 1200 New Jersey Avenue, SE., Washington,
DC 20590-0001.
     Hand Delivery: Ground Floor, Room W12-140, DOT Building,
1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.
e.t., Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number for this notice. For detailed instructions on submitting
comments and additional information on the exemption process, see the
``Public Participation'' heading below. Note that all comments received
will be posted without change to http://www.regulations.gov, including
any personal information provided. Please see the ``Privacy Act''
heading for further information.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or to Room W12-140,
DOT Building, New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19476) or you may visit http://www.regulations.gov.
    Public participation: The http://www.regulations.gov Web site is
generally available 24 hours each day, 365 days each year. You can get
electronic submission and retrieval help and guidelines under the
``help'' section of the http://www.regulations.gov Web site and also at
the DOT's http://docketsinfo.dot.gov Web site. If you want us to notify
you that we received your comments, please include a self addressed,
stamped envelope or postcard or print the acknowledgement page that
appears after submitting comments online.

FOR FURTHER INFORMATION CONTACT: Mr. Luke W. Loy, Vehicle and Roadside
Operations Division, Office of Bus and Truck Standards and Operations,
MC-PSV,<PHONE_NUMBER>; Federal Motor Carrier Safety Administration,
1200 New Jersey Avenue, SE., Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:

Background

    Section 4007 of the Transportation Equity Act for the 21st Century
(TEA- 21) [Pub. L. 105-178, June 9, 1998, 112 Stat. 107, 401] amended
49 U.S.C. 31315 and 31136(e) to provide authority to grant exemptions
from many of the Federal Motor Carrier Safety Regulations (FMCSRs). On
August 20, 2004, FMCSA published a final rule implementing section 4007
(69 FR 51589). Under this rule, FMCSA must publish a notice of each
exemption request in the Federal Register (49 CFR 381.315(a)). The
Agency must provide the public with an opportunity to inspect the
information relevant to the application, including any safety analyses
that have been conducted. The Agency must also provide an opportunity
for public comment on the request.
    The Agency reviews the safety analyses and the public comments and
determines whether granting the exemption would likely achieve a level
of safety equivalent to or greater than the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)). If the Agency denies the request, it must state the reason
for doing so. If the decision is to grant the exemption, the notice
must specify the person or class of persons receiving the exemption and
the regulatory provision or provisions from which an exemption is
granted. The notice must also specify the effective period of the
exemption (up to 2 years) and explain the terms and conditions of the
exemption. The exemption may be renewed (49 CFR 381.315(c) and
381.300(b)).

Background

    On October 7, 2005, in response to a petition for rulemaking
submitted by the Surge Brake Coalition (``the Coalition''), FMCSA
published a notice of proposed rulemaking (NPRM) to allow the use of
surge-braked trailers in interstate commerce (70 FR 58657). On March 6,
2007, FMCSA published a final rule revising the FMCSRs to allow the use
of automatic hydraulic inertia brake systems (surge brakes) on
commercial trailers when the ratios of gross vehicle weight ratings
(GVWR) for the towing vehicle and trailer are within certain limits (72
FR 9855).
    A surge brake is defined in 49 CFR 393.5 as ``A self-contained,
permanently closed hydraulic brake system for trailers that relies on
inertial forces, developed in response to the braking action of the
towing vehicle, applied to a hydraulic device mounted on or connected
to the tongue of the trailer, to slow down or stop the towed vehicle.''
    The March 2007 final rule established the requirements for surge
brakes as follows:

    393.48(d) Surge brakes. (1) Surge brakes are allowed on:
    (d)(1)(i) Any trailer with a gross vehicle weight rating (GVWR)
of 12,000 pounds or less, when its GVWR does not exceed 1.75 times
the GVWR of the towing vehicle; and
    (d)(1)(ii) Any trailer with a GVWR greater than 12,000 pounds,
but less than 20,001 pounds, when its GVWR does not exceed 1.25
times the GVWR of the towing vehicle.
    (d)(2) The gross vehicle weight (GVW) of a trailer equipped with
surge brakes may be used instead of its GVWR to calculate compliance
with the weight ratios specified in paragraph (d)(1) of this section
when the trailer manufacturer's GVWR label is missing.
    (d)(3) The GVW of a trailer equipped with surge brakes must be
used to calculate compliance with the weight ratios specified in
paragraph (d)(1) of this section when the trailer's GVW exceeds its
GVWR.
    (d)(4) The surge brakes must meet the requirements of Sec.
393.40.
    393.49 Control valves for brakes.
    (c) Surge brake exception. This requirement is not applicable to
trailers equipped with surge brakes that satisfy the conditions
specified in 393.48(d).

Innovative Electronics' Application for Exemption

    On March 30, 2010, Innovative Electronics applied for an exemption
from 49 CFR 393.48(a) and 49 CFR 393.49(a) to allow commercial motor
vehicles to tow trailers equipped with trailer-mounted electric brake
controllers. A copy of the application is included in the docket
referenced at the beginning of this notice.
    In its application, Innovative Electronics states:

    Electric brakes have been used on commercial trailers for a long
period of time; however each tow vehicle must currently be equipped
with a brake controller in the towing vehicle which applies the
trailer brakes when the driver applies the towing vehicle's brakes.
Tow vehicle brake controllers are usually aftermarket devices which
are manually adjustable to increase or decrease the amount of
electric brake force applied to the trailer wheels to adjust for wet
or dry road conditions and loaded or

unloaded trailer condition. Electric brakes on commercial trailers
will not operate unless the tow vehicle has a brake controller.
    Technology developments in electronics have allowed the
development of a self contained electric brake control device that
is mounted directly to the trailer enabling it to monitor and
actuate the brakes based on inertial forces developed in response to
the braking action of the towing vehicle. The device is essentially
an electric surge brake controller, with the electric power for the
brakes provided by the tow vehicle, but the braking action of the
trailer is controlled by the electronic controller mounted on the
trailer. A trailer using this trailer mounted electronic brake
controller does not meet the ``operative at all times'' requirement
of 49 CFR 393.48 and the brakes do not meet the ``apply by a single
application valve'' requirement of 49 CFR 393.49. Innovative
Electronics and other electric surge brake controller manufactures
have identified potential significant market penetration in
commercial trailers equipped with electric brakes. Consequently,
Innovative Electronics is requesting this exemption for all
commercial motor vehicles as defined in Sec.  390.5, for a period of
2 years.

    Innovative Electronics requests that the standards for hydraulic
surge brakes in 393.48(d) and 393.49(c) be applied to the temporary
exemption, i.e., substituting ``trailer mounted electric brake
controller'' for ``surge brake'' as follows:

    (1) Trailer-mounted electric brake controllers are allowed on:
    (i) Any trailer with a gross vehicle weight rating (GVWR) of
12,000 pounds or less, when its GVWR does not exceed 1.75 times the
GVWR of the towing vehicle; and
    (ii) Any trailer with a GVWR greater than 12,000 pounds, but
less than 20,001 pounds, when its GVWR does not exceed 1.25 times
the GVWR of the towing vehicle.
    (2) The gross vehicle weight (GVW) of a trailer equipped with a
trailer-mounted electric brake controller may be used instead of its
GVWR to calculate compliance with the weight ratios specified in
paragraph (d)(1) of this section when the trailer manufacturer's
GVWR label is missing.
    (3) The GVW of a trailer equipped with a trailer-mounted
electric brake controller must be used to calculate compliance with
the weight ratios specified in paragraph (d)(1) of this section when
the trailer's GVW exceeds its GVWR.
    (4) The trailer equipped with a trailer-mounted electric brake
controller must meet the requirements of Sec.  393.40.
    Control valves for brakes.
    (1) Trailer-mounted electric brake controller exception. This
requirement is not applicable to trailers equipped with trailer-
mounted electric brake controllers that satisfy the conditions
specified in 393.48(d).

    Without this exemption, commercial vehicle operators who tow
trailers equipped with electric brakes must continue to purchase and
install aftermarket trailer brake controls in each tow vehicle which
may be used to tow a commercial trailer equipped with electric brakes.
Similarly, rental companies will be prevented from renting trailers
equipped with electric brakes to commercial customers whose tow
vehicles are not equipped with electric brake controllers, although
they can rent such trailers to a customer for non-commercial use.
    Innovative Electronics has provided limited test data showing that
the trailer-mounted electronic brake controller appears to meet the
braking performance requirements of 49 CFR 393.52(d). These test data
have been included in the docket referenced at the beginning of this
notice. Innovative Electronics' trailer-mounted electric brake
controllers are currently available for non-commercial use trailers.
The use of trailers equipped with electric brakes is currently allowed,
and the brake performance of trailers equipped with the trailer-mounted
controller appears to be at least as good as the performance of a tow
vehicle equipped with a trailer brake controller. Trailer-mounted
electric brake controllers offer the advantage of continuous electronic
sensing of the braking forces acting on the trailer by the tow vehicle,
thus eliminating the over-application of the trailer brakes in wet or
icy conditions and continuously adjusting the application of the
trailer brakes to variations in trailer weight; this is not possible
when relying on the crude manual adjustments available on most in-cab
tow vehicle brake controllers.
    For the reasons stated above, Innovative Electronics requests that
motor carriers be permitted to use trailer-mounted electronic brake
controllers, which would eliminate the requirement for each individual
tow vehicle to be equipped with an electronic brake controller.
Innovative Electronics is making this request because it believes the
use of trailer-mounted electronic brake controllers will maintain a
level of safety that is equivalent to the level of safety achieved
without the exemption.
    FMCSA notes that, in comments submitted to the 2005 NPRM, the
Coalition stated that surge brake technology had evolved since its
petition was originally submitted, and suggested that the definition of
surge brakes may someday require modification. For example, the
Coalition noted that non-hydraulic surge brake systems had been
developed and were entering the marketplace in Europe. The Coalition
proposed that FMCSA consider deleting ``permanently closed hydraulic''
and the adjective `hydraulic' from the definition of surge brakes as
proposed in the NPRM to eliminate any future design restrictions or the
need for further rulemaking petitions.
    FMCSA responded in the March 2007 final rule, stating that ``No
data are available to the Agency regarding the performance of other
surge brake technologies to support the Coalition's request to remove
the word `hydraulic' from the definition of surge brake. If the
Coalition wishes to make such data available to FMCSA, a modification
of this definition may be evaluated.''

Request for Comments

    In accordance with 49 U.S.C. 31315 and 31136(e), FMCSA requests
public comment from all interested persons on Innovative Electronics'
application for an exemption from 49 CFR 393.48(a) and 49 CFR
393.49(a). All comments received before the close of business on the
comment closing date indicated at the beginning of this notice will be
considered and will be available for examination in the docket at the
location listed under the ADDRESSES section of this notice. Comments
received after the comment closing date will be filed in the public
docket and will be considered to the extent practicable. In addition to
late comments, FMCSA will also continue to file, in the public docket,
relevant information that becomes available after the comment closing
date. Interested persons should continue to examine the public docket
for new material.

    Issued on: February 4, 2011.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2011-2985 Filed 2-9-11; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Notices]
[Pages 81423-81425]
[FR Doc No: 2015-32713]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA 2015-0007-N-32]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and its
implementing regulations, the Federal Railroad Administration (FRA)
hereby announces that it is seeking renewal of the following currently
approved information collection activities. Before submitting these
information collection requests (ICRs) for clearance by the Office of
Management and Budget (OMB), FRA is soliciting public comment on
specific aspects of the activities identified below.

DATES: Comments must be received no later than February 29, 2016.

ADDRESSES: Submit written comments on any or all of the following
proposed activities by mail to either: Mr. Robert Brogan, Information
Collection Clearance Officer Office of Safety, Regulatory Safety
Analysis Division, RRS-21, Federal Railroad Administration, 1200 New
Jersey Ave. SE., Mail Stop 25, Washington, DC 20590, or Ms. Kimberly
Toone, Information Collection Clearance Officer, Office of Information
Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey
Ave. SE., Mail Stop 35, Washington, DC 20590. Commenters requesting FRA
to acknowledge receipt of their respective comments must include a
self-addressed stamped postcard stating, ``Comments on OMB control
number 2130-__.'' Alternatively, comments may be transmitted via
facsimile to<PHONE_NUMBER> or<PHONE_NUMBER>, or via email to Mr.
Brogan at<EMAIL_ADDRESS>or to Ms. Toone at<EMAIL_ADDRESS>
Please refer to the assigned OMB control number in any correspondence
submitted. FRA will summarize comments received in response to this
notice in a subsequent notice and include them in its information
collection submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Information
Collection Clearance Officer, Regulatory Safety Analysis Division, RRS-
21, Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail
Stop 25, Washington, DC 20590 (telephone:<PHONE_NUMBER>) or Ms.
Kimberly Toone, Information Collection Clearance Officer, Office of
Information Technology, RAD-20, Federal Railroad Administration, 1200
New Jersey Ave. SE., Mail Stop 35, Washington, DC 20590 (telephone:
(202) 493-6132). (These telephone numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law 104-13, sec. 2, 109 Stat. 163 (1995) (codified as revised at
44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part
1320, require Federal agencies to provide 60-days notice to the public
for comment on information collection activities before seeking
approval for reinstatement or renewal by OMB. 44 U.S.C. 3506(c)(2)(A);
5 CFR 1320.8(d)(1), 1320.10(e)(1), 1320.12(a). Specifically, FRA
invites interested respondents to comment on the following summary of
proposed information collection activities regarding (i) whether the
information collection activities are necessary for FRA to properly
execute its functions, including whether the activities will have
practical utility; (ii) the accuracy of FRA's estimates of the burden
of the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (iii) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (iv) ways for FRA to minimize the burden of
information collection activities on the public by automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology (e.g., permitting electronic
submission of responses). See 44 U.S.C. 3506(c)(2)(A)(I)-(iv); 5 CFR
1320.8(d)(1)(I)-(iv). FRA believes that soliciting public comment will
promote its efforts to reduce the administrative and paperwork burdens
associated with the collection of information mandated by Federal
regulations. In summary, FRA reasons that comments received will
advance three objectives: (i) Reduce reporting burdens; (ii) ensure
that it organizes information collection requirements in a ``user
friendly'' format to improve the use of such information; and (iii)
accurately assess the resources expended to retrieve and produce
information requested. See 44 U.S.C. 3501.
    Below is a brief summary of the currently approved ICRs that FRA
will submit for clearance by OMB as required under the PRA:
    Title: System for Telephonic Notification of Unsafe Conditions at
Highway-Rail and Pathway Grade Crossings.
    OMB Control Number: 2130-0591.
    Abstract: The collection of information is set forth under 49 CFR
part 234. The rule is intended specifically to help implement Section
205 of the Rail Safety Improvement Act of 2008 (RSIA), Public Law 110-
432, Division A, which was enacted on October 16, 2008. Generally, the
rule is intended to increase safety at highway-rail and pathway grade
crossings. Section 205 of the RSIA mandates that the Secretary of
Transportation require certain railroad carriers to take a series of
specified actions related to setting up and using systems by which the
public is able to notify the railroad by toll-free telephone number of
safety problems at its highway-rail and pathway grade crossings. Such
systems are commonly known as Emergency Notification Systems (ENS) or
ENS programs. 49 CFR part 234 implements Section 2015 of the RSIA. The
information collected is used by FRA to ensure that railroad carriers
establish and maintain a toll-free telephone service to report
emergencies at all public, private, and pedestrian grade crossings for
rights-of-way over which they dispatch trains.
    Form Number(s): N/A.
    Affected Public: Businesses.
    Respondent Universe: Railroads.
    Frequency of Submission: On occasion.
    Reporting Burden:

----------------------------------------------------------------------------------------------------------------
                                        Respondent          Total annual       Average time per    Total annual
           CFR Section                   universe            responses             response        burden hours
----------------------------------------------------------------------------------------------------------------
234.303(b)--Receipt by             594 railroads......  63,891 reports.....  1 minute...........           1,065
 dispatching RR of report of
 unsafe condition at highway-rail
 grade crossing.
    --(d)--Receipt by dispatching  594 railroads......  1,850 reports/1,860  1 minute + 1 minute              62
     RR of report of unsafe                              records.
     condition at pathway grade
     crossing.

234.305(a)(2)--Immediate contact   594 railroads......  465 contacts.......  1 minute...........               8
 by dispatching RR not having
 maintenance responsibility of
 all trains authorized to operate
 through the crossing in response
 to credible report of warning
 system malfunction at highway-
 rail grade crossing.
    --(a)(2)--Contact of crossing  594 railroads......  465 contacts + 465   1 minute + 1 minute              16
     maintenance RR by                                   records.
     dispatching RR not having
     maintenance responsibility
     in response to credible
     report of warning system
     malfunction at highway-rail
     grade crossing.
    --(b)(1)--In response to       594 railroads......  925 contacts + 925   1 minute + 1 minute              30
     public report of warning                            records.
     system malfunction at
     highway-rail grade crossing
     immediate contact by
     dispatching RR having
     maintenance duty for
     crossing of all trains
     authorized to operate
     through that crossing.
    --Dispatching RR having        594 railroads......  925 contacts.......  1 minute...........              15
     maintenance duty for
     crossing contact of
     appropriate law enforcement
     authority with necessary
     information regarding
     reported malfunction.
234.305(b)(2)--In response to      594 railroads......  920 contacts.......  1 minute...........              15
 public report of warning system
 malfunction at highway-rail
 grade crossing immediate contact
 by dispatching RR not having
 maintenance duty for that
 crossing of all trains
 authorized to operate through
 that crossing.
    --Dispatching RR contact of    594 railroads......  920 contacts.......  1 minute...........              15
     law enforcement authority to
     direct traffic/maintain
     safety.
    --Dispatching RR contact of    594 railroads......  920 contacts + 920   1 minute + 1 minute              30
     maintaining RR re: reported                         records.
     malfunction and maintaining
     record of unsafe condition.
    --(c)(1)--In response to       594 railroads......  2 contacts + 2       1 minute...........          .06666
     report of warning system                            records.
     failure at pathway grade
     crossing dispatching RR
     having maintenance duty
     contact of all trains
     authorized to operate
     through it and record of
     unsafe condition.
    --Dispatching RR contact of    594 railroads......  2 contacts.........  1 minute...........           03333
     law enforcement authority
     agencies to direct traffic/
     maintain safety after above
     report.
234.305(d)(1)--Dispatching RR      594 railroads......  7,440 contacts       1 minute + 1 minute             248
 having maintenance authority                            +7,440 rcds..
 contact of all trains operating
 through highway-rail or pathway
 grade crossing after report of
 disable vehicle.
    --Dispatching RR having        594 railroads......  7,440 contacts.....  1 minute...........             124
     maintenance duty contact of
     law enforcement authority
     after report of disabled
     vehicle/other obstruction.
(d)(2)--Dispatching RR not having  594 railroads......  2,556 contacts.....  1 minute...........              43
 maintenance authority contact of
 all trains operating through
 highway-rail or pathway grade
 crossing after report of disable
 vehicle/unsafe condition.
    --Dispatching RR contact not   594 railroads......  2,556 contacts.....  1 minute...........              43
     having maintenance authority
     contact of all trains
     operating through highway-
     rail or pathway grade
     crossing after report of
     disable vehicle/other unsafe
     condition.
    --Dispatching RR contact of    594 railroads......  2,556 contacts +     1 minute + 1 minute              86
     maintaining RR regarding                            2,556 record.
     unsafe condition at crossing
     & record of unsafe condition.
(h)--Provision of contact          594 railroads......  10 contacts........  594 railroads......           .1667
 information by maintaining RR to
 dispatching RR for reports of
 unsafe conditions at highway-
 rail and pathway grade crossings.
234.306(a)--Appointment of one     594 railroads......  50 indications &     60 minutes.........              50
 (1) dispatching RR as primary                           records.
 dispatching RR where multiple
 RRs dispatch trains through the
 same highway-rail and pathway
 grade crossing to provide info.
 for ENS sign.
(b)--Appointment of one (1)        594 railroads......  50 indications/      60 minutes.........              50
 maintaining RR as primary                               records.
 maintaining RR where multiple
 RRs dispatch trains through the
 same highway-rail and pathway
 grade crossing to provide info.
 for ENS sign.
234.307(b)--3rd Party telephone    594 railroads......  50 reports + 50      1 minute + 1 minute               2
 service report of unsafe                                records.
 condition at highway-rail or
 pathway grade crossing to
 maintaining RR and maintaining
 RR record of unsafe condition.
(c)--3rd Party telephone service   594 railroads......  50 reports.........  1 minute...........               1
 report to dispatching RR of
 unsafe condition.
(d)(1)--Provision of contact       594 railroads......  17 contact calls...  15 minutes.........               4
 information to 3rd party
 telephone service or maintaining
 RR using that service to receive
 reports of unsafe condition at
 highway-rail or pathway grade
 crossings.
(d)(2)--Written notice by RR to    594 railroads......  17 letters.........  60 minutes.........              17
 FRA of intent to use 3rd party
 service.
(d)(3)--RR written notification e  594 railroads......  5 letters..........  60 minutes.........               5
 by RR of any changes in use or
 discontinuance of 3rd party
 service.
234.309(a)--ENS Signs--General--   594 railroads......  10 contacts........  30 minutes.........               5
 Provision of ENS telephone
 number to maintaining RR by
 dispatching RR if two RRs are
 not the same.
(b)--ENS Signs located at highway- 594 railroads......  81,948 signs.......  30 minutes.........          40,974
 rail or pathway grade crossings
 as required by Sec.   234.311
 with necessary information to
 receive reports required under
 Sec.   234.303.

234.311(c)--Repair or replacement  594 railroads......  4,000 signs........  15 minutes.........           1,000
 of ENS after discovery by
 responsible railroad of missing,
 damaged, or otherwise unusable/
 illegible sign to vehicular/
 pedestrian traffic.
234.313--Recordkeeping--Records    594 railroads......  186,000 signs......  4 minutes..........          12,400
 of reported unsafe conditions
 pursuant to Sec.   234.303.
----------------------------------------------------------------------------------------------------------------

    Total Estimated Responses: 56,445.
    Total Estimated Total Annual Burden: 56,308 hours.
    Type of Request: Extension of a currently approved collection.
    Title: Control of Alcohol and Drug Use in Railroad Operations:
Addition of Post-Accident Toxicological Testing for Non-Controlled
Substances.
    OMB Control Number: 2130-0598.
    Abstract: Since 1985, as part of its accident investigation
program, FRA has conducted post-accident alcohol and drug tests on
railroad employees who have been involved in serious train accidents
(50 FR 31508, Aug. 2, 1985). If an accident meets FRA's criteria for
post-accident testing (see 49 CFR 219.201), FRA conducts tests for
alcohol and for certain drugs classified as controlled substances under
the Controlled Substances Act (CSA), Title II of the Comprehensive Drug
Abuse Prevention Substances Act of 1970 (CSA, 21 U.S.C. 801 et seq.).
Controlled substances are drugs or chemicals that are prohibited or
strictly regulated because of their potential for abuse or addiction.
The Drug Enforcement Agency (DEA), which is primarily responsible for
enforcing the CSA, oversees the classification of controlled substances
into five schedules. Schedule I contains illicit drugs, such as
marijuana and heroin, which have no legitimate medical use under
Federal law. Currently, FRA routinely conducts post-accident tests for
the following drugs: marijuana, cocaine, phencyclidine (PCP), and
certain opiates, amphetamines, barbiturates, and benzodiazepines.
Controlled substances are drugs or chemicals that are prohibited or
strictly regulated because of their potential for abuse or addiction.
    FRA research indicates that prescription and OTC drug use has
become prevalent among railroad employees. For this reason, FRA has
added certain non-controlled substances to its routine post-accident
testing program, which currently routinely tests only for alcohol and
controlled substances. At this time, FRA is adding two types of non-
controlled substances, tramadol (a synthetic opioid) and sedating
antihistamines. Publication of the PATT Final Rule, however, in no way
limits FRA's post-accident testing to the identified substances or in
any way restricts FRA's ability to make routine amendments to its
standard post-accident testing panel without prior notice. Furthermore,
in addition to its standard post-accident testing panel, FRA always has
the ability to test for ``other impairing substances specified by FRA
as necessary to the particular accident investigation.'' See 49 CFR
219.211(a). This flexibility is essential, since it allows FRA to
conduct post-accident tests for any substance (e.g., carbon monoxide)
that its preliminary investigation shows may have played a role in an
accident.
    FRA uses the additional information collected for research and
accident investigation purposes. The addition of non-controlled
substances to the post-accident testing panel helps inform FRA about a
broader range of potentially impairing prescription and OTC drugs that
may be currently contributing to the cause or severity of train
accidents/incidents. Research generated by these data will inform
future agency policy decisions regarding these non-controlled
substances.
    Form Number(s): N/A.
    Affected Public: Businesses.
    Respondent Universe: 698 railroads.
    Frequency of Submission: On occasion.

----------------------------------------------------------------------------------------------------------------
                                        Respondent          Total annual       Average time per    Total annual
           CFR section                   universe            responses             response        burden hours
----------------------------------------------------------------------------------------------------------------
219.211(a)(b)(c)--RR Medical       698 railroads......  16 reports + 16      15 minutes + 5                    5
 Review Officer (MRO) review of                          report copies.       minutes.
 employee post-accident
 toxicological testing result
 reported as positive for alcohol
 or a controlled substance by
 designated laboratory and MRO
 report to FRA of Review Results.
----------------------------------------------------------------------------------------------------------------

    Total Estimated Responses: 32.
    Total Estimated Annual Burden: 5 hours.
    Status: Regular Review.
    Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b),
1320.8(b)(3)(vi), FRA informs all interested parties that it may not
conduct or sponsor, and a respondent is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.

    Authority: 44 U.S.C. 3501-3520.

    Issued in Washington, DC on December 23, 2015.
Corey Hill,
Acting Executive Director.
[FR Doc. 2015-32713 Filed 12-28-15; 8:45 am]
 BILLING CODE 4910-06-P