[Federal Register Volume 76, Number 16 (Tuesday, January 25, 2011)]
[Proposed Rules]
[Pages 4271-4276]
[FR Doc No: 2011-1477]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2007-0649; FRL-9256-5]

Approval and Promulgation of State Implementation Plans; State of
Colorado Regulation Number 3: Revisions to the Air Pollutant Emission
Notice Requirements and Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing partial approval and partial disapproval of
State Implementation Plan (SIP) revisions regarding the Air Pollutant
Emission Notice (APEN) regulations submitted by the State of Colorado
on September 16, 1997, June 20, 2003, July 11, 2005, August 8, 2006 and
August 1, 2007. The APEN provisions in Sections II.A. through II.D.,
Part A of Colorado's Regulation Number 3, specify the APEN filing
requirements for stationary sources and exemptions from such
requirements. This action is being taken under section 110 of the Clean
Air Act (CAA).

DATES: Comments must be received on or before February 24, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2007-0649, by one of the following methods:
     http://www.regulations.gov. Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER> (please alert the individual listed in
the FOR FURTHER INFORMATION CONTACT if you are faxing comments).
     Mail: Callie Videtich, Director, Air Program,
Environmental Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595
Wynkoop Street, Denver, Colorado 80202-1129.
     Hand Delivery: Callie Videtich, Director, Air Program,
Environmental Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595
Wynkoop, Denver, Colorado 80202-1129. Such deliveries are only accepted
Monday through Friday, 8 a.m. to 4:30 p.m., excluding Federal holidays.
Special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-R08-OAR-
2007-0649. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA, without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional instructions on submitting
comments, go to Section I. General Information of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air Program,
Environmental Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595
Wynkoop, Denver, Colorado 80202-1129. EPA requests that if at all
possible, you contact the individual listed in the FOR FURTHER
INFORMATION CONTACT section to view the hard copy of the docket. You
may view the hard copy of the docket Monday through Friday, 8 a.m. to 4
p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Crystal Freeman, Air Program, U.S.
Environmental Protection Agency, Region 8, Mailcode 8P-AR, 1595
Wynkoop, Denver, Colorado 80202-1129,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The words or initials Act or CAA mean or refer to the Clean Air
Act, unless the context indicates otherwise.
    (ii) The words EPA, we, us or our mean or refer to the United
States Environmental Protection Agency.
    (iii) The initials SIP mean or refer to State Implementation Plan.

    (iv) The words Colorado and State mean the State of Colorado.

Table of Contents

I. General Information
II. Background
III. What action is EPA proposing?
IV. What is the State process to submit these materials to EPA?
V. EPA's Review and Technical Information
VI. Proposed Action
VII. Statutory and Executive Order Reviews

I. General Information

    1. Submitting CBI. Do not submit CBI to EPA through http://www.regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
    a. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
    b. Follow directions--The agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    c. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    d. Describe any assumptions and provide any technical information
and/or data that you used.
    e. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    f. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    g. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    h. Make sure to submit your comments by the comment period deadline
identified.

II. Background

    The Colorado APEN provisions in Regulation Number 3, Part A,
Sections II.A. through II.C., specify requirements for stationary
sources (major and minor) to file emission notices. These notices
provide information such as the location where a source's emissions
will occur, the nature of the source or of the activity generating the
expected emissions, and an estimate of the emissions' quantity and
composition. The Colorado APEN provisions in Regulation Number 3, Part
A, Section II.D. exempt specific categories of sources from APEN
requirements.
    EPA's last final rulemaking action addressing revisions to
Colorado's APEN provisions was published January 21, 1997 (62 FR 2910).
The action proposed today addresses the APEN SIP revisions submitted by
the State of Colorado between 1997 and 2007 with Governor's letters
dated as follows: September 16, 1997; June 20, 2003; July 11, 2005;
August 8, 2006; and August 1, 2007. EPA's evaluation of the revisions
submitted by the State does not trace the APEN provision changes
through each of the submissions noted above. For reasons of efficiency
and clarity, EPA compared the language of each APEN provision as
submitted by the State on August 1, 2007 with the EPA-approved text of
the same APEN provision in the 1997 Colorado SIP. For each provision,
the substantive language changes, EPA's proposed action, EPA's comments
about the general nature of the changes, and the rationale for the
Agency action are reported in Table 1 of the Technical Support Document
(TSD) underpinning our proposed action.\1\ For actions involving a
provision's proposed disapproval our analysis does reference and
address relevant material supporting the revision's adoption by the
State. In some cases, EPA asked the State for clarification of
revisions; these clarifications are also available in the docket.
Through this approach to the cumulative revisions, EPA intends for this
proposed rule action to address all APEN revisions as submitted by the
State of Colorado on September 16, 1997, June 20, 2003, July 11, 2005,
August 8, 2006, and August 1, 2007.
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    \1\ EPA's Technical Support Document (TSD), part of the docket
for this proposed action (accessible on the regulations.gov Web site
under Docket Number EPA-R08-OAR-2007-0649) clearly identifies for
each of the APEN provisions the cumulative effect of the revisions
(if any) adopted by the State between 1997 and 2007. The TSD's Table
1 lists all the APEN provisions (requirements and exemptions) and
for each it provides: the provision number in the 1997 EPA-approved
SIP, and in the 2007 State submittal; a short description or title
of the provision, and cumulative language changes from 1997 to 2007;
EPA's proposed action (Approval, Disapproval, or No Action); and
EPA's comments summarizing the nature of the changes, and providing
a rationale for supporting the proposed action. EPA believes that
this approach allows a clear understanding of the overall revisions
adopted by the State for each provision and of the rationale for the
Agency's proposed action. The cumulative revisions identified in
Table 1 of the TSD were part of the Colorado submissions dated
September 16, 1997, June 20, 2003, July 11, 2005, August 8, 2006 and
August 1, 2007.
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III. What action is EPA proposing?

    EPA is proposing: (a) To approve some of the revisions to the
Colorado APEN provisions submitted to EPA on September 16, 1997; June
20, 2003; July 11, 2005; August 8, 2006; and August 1, 2007; (b) to
disapprove some of the revisions; and (c) to not take action on a few
revisions unrelated to the SIP or to maintenance of the National
Ambient Air Quality Standards (NAAQS). As mentioned in section II
above, the specific provisions we propose to approve, disapprove, or
not act on are identified in the TSD; those that require extended
analysis are discussed in section V below.

IV. What is the State process to submit these materials to EPA?

    Section 110(k) of the CAA addresses EPA's rulemaking action on SIP
submissions by states. The CAA requires states to observe certain
procedural requirements in developing SIP revisions for submittal to
EPA. Section 110(a)(2) of the CAA requires that each SIP revision be
adopted after reasonable notice and public hearing. This must occur
prior to the revision being submitted by a state to EPA.
    The Colorado Air Quality Control Commission (AQCC) held public
hearings for, and adopted, on March 31, 1996 the APEN revisions
submitted to EPA September 16, 1997. On June 20, 2003 Colorado
submitted two APEN revision packages. For the first package, public
hearing and adoption dates were respectively February 21 and July 18,
2002. For the second, the revisions were submitted to public hearing
and adopted on the same October 17, 2002 date. For APEN revisions
submitted to EPA on July 11, 2005, the Colorado AQCC held public
hearings February 19, April 15, and April 16, 2004, and adopted the
revisions on the latter date. The Colorado AQCC held a public hearing
on December 16, 2004 for APEN revisions adopted the same day and
submitted to EPA August 8, 2006. For the last of the submissions
considered in this action, APEN revisions submitted to EPA on August 1,
2007, the Colorado AQCC public hearing and adoption took place on
August 17, 2006.
    EPA has reviewed the submittals by the State of Colorado and has
determined that the State met the requirements for reasonable notice
and public hearing under section 110(a)(2) of the CAA. All Colorado
APEN

revisions submittals referenced above, and addressed in this action,
became complete by operation of law under section 110(k)(1)(B) of the
CAA six months after their submittal dates.

V. EPA's Review and Technical Information

    As indicated in the Background section of this action, for each of
the APEN provisions in Regulation Number 3, Part A, Sections II.A.
through II.D., EPA's TSD identifies the cumulative revisions submitted
by the State between 1997 and 2007, provides EPA's assessment of the
revisions, and indicates EPA's proposed action (approval, no action, or
disapproval). The TSD compares the cumulative revisions of each APEN
provision with the current EPA-approved language of the same provision,
effective as of February 20, 1997.\2\ For revisions to APEN provisions
that must be addressed in greater detail, EPA's evaluation references
the specific submittal or submittals affecting the changes, their
related material, as well as any subsequent information/clarification
provided to EPA by the State of Colorado. All material contributing to
EPA's proposed action is referenced appropriately and made available
for review as part of the docket supporting the Agency's proposed
rulemaking.
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    \2\ 62 FR 2910, January 21, 1997.
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    For clarity, EPA's evaluation of the APEN revisions submitted by
the State of Colorado between 1997 and 2007 considers four groups
identified according to EPA's action. The first group consists of the
APEN provisions that the State did not revise between September 1997
and August 2007. These provisions retained in the 2007 APEN submission
are the same language as the provisions in the 1997 EPA-approved
Colorado SIP. For this group of APEN provisions there are no SIP
revisions for EPA to propose action on. The second group consists of
the APEN provisions for which the State had adopted only clerical
changes, such as grammar or style changes, that do not reflect any
substantive modifications. For example, some of the changes expanded
abbreviations such as ``APEN,'' and others replaced the digits of a
numerical value with its equivalent text--i.e., ``four hundred''
instead of ``400.'' EPA proposes to approve all the clerical revisions
submitted by the State of Colorado between September 16, 1997 and
August 1, 2007.
    The third and fourth groups consist of the Colorado APEN provisions
that underwent substantive revisions; the third group are those
provisions EPA proposes to approve and the fourth those EPA proposes to
disapprove. In general, our evaluation of each substantive revision
assesses whether the revision makes the SIP more or less stringent, or
weakens protection of the NAAQS. In carrying this out, we consider
whether the revisions satisfied recordkeeping and reporting
requirements set out in 40 CFR 51.211. We also consider whether the
revisions affected the applicability of substantive provisions
elsewhere within the SIP. In particular, a source that is exempt from
APEN requirements is also exempt from construction permitting
requirements (see Regulation 3, Part B, Section III.D.1.a). As a
result, the requirements for stationary sources at 40 CFR 51.160 are
implicated by the submitted APEN exemptions we review in this proposal.
    For many of the provisions affected by the substantive revisions
submitted by the State, EPA's rationale for its proposed action is
explained and provided in Table 1 of the TSD. For the remaining
provisions, affected by revisions requiring more complex and detailed
evaluations, we do so in the following paragraphs.
    We examine first the revisions that EPA proposes to approve, in the
order as they appear in Regulation 3. Provision II.B.1.b.\3\ pertains
to alternative methods for emissions estimates. The language of the
1997 EPA-approved provision included a reference to ``Section II.E.2.
of this Regulation No. 3, Part A.,'' which addressed deferrals of APEN
reporting timelines--a subject unrelated to the issue of emissions
estimates and alternative methods. This reference was an obvious
clerical error corrected by the State, with the June 20, 2003
submission,\4\ to ``Section II.C.2.'' The corrected reference, on the
other hand, specifies thresholds for significant emission changes,
which relate to the accuracy required for emission estimates. The lower
the significant emission changes threshold, the greater the precision
required of an acceptable alternate emissions estimate. EPA therefore
proposes to approve this correction.
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    \3\ Unless otherwise specified, all references to sections in
the remainder of this notice are to sections in Part A of Regulation
3.
    \4\ This revision was adopted by Colorado AQCC July 18, 2002.
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    EPA also proposes to approve revisions to II.B.3.a., which sets
thresholds (in tons per year) of criteria pollutants for APEN
applicability. The revisions clarify the understanding that the one ton
per year (tpy) threshold in nonattainment areas applies to the
pollutants for which the area is in nonattainment. EPA proposes
approval of this revision because the change does not make the SIP less
stringent or affect the ambient air quality.
    Next, APEN provision II.B.9. of the EPA-approved SIP identifies
criteria pollutants for the purpose of APEN applicability. The Colorado
AQCC adopted on April 16, 2004 the revised provision that was submitted
to EPA on July 11, 2005; Colorado retained the same language in the
August 8, 2006 and August 1, 2007 submissions. The revision generally
defines criteria pollutants as those for which EPA has established a
NAAQS. The revision also identifies NOx and volatile organic compounds
(VOCs) as precursors to ozone. EPA proposes approval of this revision
because it makes the definition of criteria pollutants (for the
purposes of APEN applicability) consistent with the federal definition.
In the same submittal, the AQCC renumbered the provision to I.B.16. EPA
is also proposing to approve this renumbering, which does not affect
the applicability of the provision. EPA notes that since prior to this
renumbering Section I.B.16 was ``reserved,'' the move of II.B.9 to this
section does not replace any other provision, and therefore does not
impact the stringency of the SIP.
    EPA is also proposing to approve the revision to II.C.1.h.
submitted on July 11, 2005. The revision is intended to update the
reference to the definition of ``major stationary source.'' However,
the reference specified, Section II.A.25., gives the definition of
``Minor Source Baseline Date,'' while Section II.A.24. defines ``Major
Stationary Source.'' EPA has discussed this with the State; the State
concurs that the reference should be ``Section II.A.24.'' and has
agreed to correct this discrepancy in a later submittal to EPA. Given
that the correct reference can be determined from the context, EPA
proposes approval of the revision.
    A revision to II.C.3.d was submitted to EPA on August 8, 2006. The
revised provision changes the time APENs are due for control equipment
at condensate storage tanks located at oil and gas exploration
facilities. However, the revision does not exempt such sources from
reporting and therefore does not relieve them from any substantive
requirements of the SIP. As the revision does not impact emission
levels and ambient air quality standards, EPA is proposing to approve
it.
    We turn to exemptions from APEN requirements that have been added
to Section II.D.1 in the submittals. First, II.D.1.nnn exempts
``Fugitive emissions

of hazardous air pollutants that are natural constituents of native
soils and rock (not added or concentrated by chemical or mechanical
processes) from underground mines or surface mines unless such source
is a major source of hazardous air pollutants under Part C of
Regulation No. 3.'' The provision was adopted on March 31, 1996, and
submitted to the EPA on September 16, 1997. This exemption will not
affect any substantive requirement in the SIP relating to emissions of
criteria pollutants and thus EPA is proposing approval.
    EPA is also proposing approval of the exemption in APEN provision
II.D.1.ooo: ``The use of pesticides, fumigants, and herbicides when
used in accordance with requirements established under the Federal
Insecticide, Fungicide and Rodenticide Act as established by the U.S.
EPA (United States Code Title 7, Section 136 et seq.).'' The exemption
was adopted on March 31, 1996, and submitted to the EPA on September
16, 1997. Such sources are not elsewhere regulated in the SIP and
therefore EPA proposes approval of this exemption.
    The exemption in II.D.1.ppp, ``Ventilation of emissions from mobile
sources operating within a tunnel, garage, or building,'' was submitted
to EPA on September 16, 1997. EPA proposes approval of this revision to
the Colorado APEN SIP on the basis of the following considerations. The
Colorado APEN reporting requirements are applicable only to stationary
sources (see Regulation Number 3, Part A, Section II.A.). Section
302(z) of the (CAA) defines stationary sources as ``any source of an
air pollutant except those emissions resulting from an internal
combustion engine for transportation purposes * * *.'' The exemption
applies only when a mobile source (as defined in Regulation 3) is
operating for transportation purposes. We recommend that in a future
SIP revision the State of Colorado clarify the applicability of the
current provision.
    EPA also proposes to approve the exemption in Section II.D.1.dddd.,
applicable to ``Non-road engines as defined in Section I.B.29. of this
Part A, except certain non-road engines subject to state-only air
pollutant emission notice and permitting requirements pursuant to
Section I.B.29.c. of this part.'' The definition of non-road engines in
Section I.B.29 is consistent with the federal definition of non-road
engine at 40 CFR 1068.30. Under section 302(z) of the CAA non-road
engines are specifically excluded from the definition of stationary
sources, to which the Colorado APEN requirements apply (see Section
II.A.).
    APEN substantive revisions submitted by the State to EPA between
September 16, 1997 and August 1, 2007 include revisions to or additions
of five exemption provisions that EPA proposes to disapprove. The first
revision we propose to disapprove regards the APEN exemption for open
burning activities, in Section II.D.1.q. During the period considered
here, some of the open burning provisions were moved by the State from
Regulation Number 1 to Regulation Number 9 (which is a State-only
Regulation, and therefore outside the Colorado SIP) and then back to
Regulation Number 1. At the same time, Colorado submitted a June 20,
2003 revision of the ``Open burning activities'' provision in Section
II.D.1.q. that changed a reference to Regulation Number 1 (part of the
Colorado SIP) into a reference to Regulation Number 9. Since, as noted
above, Regulation Number 9 is enforceable only by the State, EPA
proposes to disapprove the change to the reference to Regulation Number
9.
    EPA is proposing to disapprove the APEN provision at Section
II.D.1.xxx. exempting ``Deaerator/vacuum pump exhausts,'' adopted on
March 31, 1996 and submitted to EPA on September 16, 1997. This
provision would potentially exempt emissions both from the devices and
from the liquid or gas the device operates on. If the liquid or gas
operated on contains high levels of criteria pollutants or their
precursors (either in a dissolved form in liquid or mixed in gas), then
high levels of criteria pollutants may be emitted from these devices.
As APEN exemptions are linked to exemption from construction
permitting, this exemption may increase emissions of criteria
pollutants (or their precursors). Under section 110(l) of the Act, EPA
cannot approve a SIP revision if it would interfere with any applicable
requirement concerning attainment and reasonable further progress or
any other applicable requirement of the Act. Furthermore, as these
stationary sources may emit significant amounts of criteria pollutants,
the exemption from permitting fails to ensure that construction or
modification of these sources will not interfere with attainment or
maintenance of the NAAQS (see 40 CFR 51.160(a)(2)). EPA therefore
proposes to disapprove the exemption in II.D.1.xxx.
    EPA also proposes to disapprove APEN exemption A-II.D.1.sss and its
subprovisions A-II.D.1.sss.(i) through A-II.D.1.sss.(iii). This
provision exempts three tiers of stationary internal combustion engines
from APEN requirements. The tiers are defined by engine horsepower and
hours of operation per year: (1) Those engines less than or equal to
175 horsepower that operate less than 1450 hours per year; (2) those
greater than 175 horsepower and less than or equal to 300 horsepower
that operate less than 850 hours per year; and (3) those greater than
300 horsepower that operate less than 340 hours per year. As a result
of the exemption from APEN requirements, such engines are also exempt
from construction permit requirements in Part B of Regulation 3 (see
Part B, Section III.D.1.a).
    The provision does not require owners or operators that claim the
exemption to keep records of the hours of operation. As a result, the
limit on the hours of operation is unenforceable. In parallel instances
where a source seeks to limit its potential to emit (``PTE'') through
an operational limitation (such as on hours of operation) in a permit,
EPA guidance recommends that the limitation be enforceable as a
practical matter. (Memorandum from Terrell E. Hunt & John S. Seitz
entitled ``Guidance on Limiting Potential to Emit in New Source
Permitting'' (June 13, 1989).) The guidance specifically notes,
``permits with limits on hours of operation * * * should require an
operating log in which the actual hours of operation * * * are
recorded.'' (Id. at 6.) The logs should be made available to the
permitting authority, which allows it to verify compliance with the
limit. Although this recommendation is in the context of practical
enforceability of operational limitations in a permit, the underlying
principle applies to enforceability of SIP provisions. Section
110(a)(2)(A) of the CAA requires that emission limitations in a SIP be
enforceable.\5\ Under the principle set out in the guidance discussed
above, the provision is unenforceable, as there is no requirement to
keep records of hours of operation.
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    \5\ In addition, 40 CFR 51.160(a)(1) requires SIPs contain
legally enforceable procedures for determining whether construction
or modification of a stationary source will violate applicable
portions of the control strategy, and 40 CFR 51.211(b) requires SIPs
contain legally enforceable procedures for requiring owners and
operators of stationary sources to keep records necessary to
determine compliance with applicable portions of the control
strategy.
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    Without an enforceable limit on the hours of operations, engines in
even the lowest tier (175 horsepower or less) may emit up to 8.4 tons
per year (``tpy'') of NOX for gasoline fuel or 23.8 tpy of
NOX for diesel fuel, if operated for the full year. This is
considerably above the level for the existing source-specific

exemption from construction permitting for stationary internal
combustion engines (Part B, III.D.1.c(iii)), which is capped at 5 tons
per year.
    This in turn raises another issue. Section 110(l) of the Act
provides that EPA shall not approve a SIP revision if it would
interfere with any applicable requirement concerning attainment and
reasonable further progress or any other applicable requirement of the
Act. Due to the linked exemption from construction permitting,
emissions of criteria pollutants and their precursors (such as, again,
NOX) may increase as a result of the exemption from APEN
requirements. For this reason, and for the reason that the provision
appears to be unenforceable, EPA proposes to disapprove the addition of
the exemption in A.II.D.1.sss to the SIP.
    Similar issues are raised by the exemption in A-II.D.1.ttt. This
provision exempts three tiers of emergency power generators from APEN
requirements: (1) Those with a rated horsepower of less than 260; (2)
those that operate no more than 250 hours per year and have a rated
horsepower of less than 737; and (3) those that operate no more than
100 hours per year and have a rated horsepower of less than 1,840. For
similar reasons to those discussed above, EPA regards the limitations
on hours in tiers 2 and 3 as unenforceable and therefore proposes to
disapprove subprovisions A-II.D.1.ttt.(ii) and A-II.D.1.ttt.(iii).
Sources in tier 1, on the other hand, do not have a limit on hours of
operation. However, as tier 1 includes generators up to 260 hp,
emissions from these sources may be even greater than the emissions
from the first tier stationary internal combustion engines discussed
above. As with those engines, this raises the issue of compliance with
section 110(l) of the Act. EPA therefore proposes to also disapprove
the exemption in A-II.D.1.ttt.(i).
    EPA also proposes to disapprove the exemption in Section
II.D.1.ffff., applicable to ``Air Curtain Destructors burning only yard
waste, wood waste, and clean lumber, or any mixture thereof generated
as a result of projects to reduce the risk of wildfire and are not
located at a commercial or industrial facility.'' The exemption does
not apply to ``[a]ir curtain incinerators that are considered
incinerators as defined by the Common Provisions.'' The exemption in
II.D.1.ffff. was submitted to EPA on August 1, 2007.
    Under the definition of ``incinerator'' in a subsequent revision to
the Common Provisions of Colorado's SIP, air curtain destructors that
are subject to a New Source Performance Standard (NSPS) are considered
``incinerators.'' On December 16, 2005, EPA published a final rule (70
FR 74870) for NSPS and emission guidelines for new and existing
``other'' solid waste incineration units (OSWI). Under this rule, air
curtain destructors (called air curtain incinerators in the rule) are
subject to an NSPS. As a result, this exemption, II.D.1.ffff., is
superseded. Additionally, Colorado has agreed that this exemption,
II.D.1.ffff., is no longer valid and thus EPA is proposing disapproval.
    APEN revisions submitted by the State to EPA between September 16,
1997 and August 1, 2007 include revisions to six provisions that EPA
proposes to take no action on. The first revisions we propose to take
no action on are: II.D.1.m; II.D.1.ee; II.D.1.uu; II.D.1.ddd; and
II.D.1.eeee. EPA is proposing to not act on these provisions in this
Federal Register action, because EPA has already proposed approval of
the repeal of these exemptions in a separate action published on July
21, 2010 (75 FR 42346). Additionally, EPA is not proposing action on
the revision to APEN exemption II.D.1.uuu., because we proposed
approval of the revision in the same July 21, 2010 proposal.

VI. Proposed Action

    EPA is proposing partial approval and partial disapproval of the
Colorado SIP revisions for APEN requirements and exemptions submitted
by the State on September 16, 1997, June 20, 2003, July 11, 2005,
August 8, 2006, and August 1, 2007. As noted above, EPA's evaluation of
the revisions submitted by the State does not track the APEN provision
changes through each of the submissions (to avoid having to evaluate
revisions that may be significantly modified or even reversed in
subsequent submittals), but for each provision compares the textual
changes between the EPA-approved Colorado APEN provisions effective
February 21, 1997, and the Colorado-adopted APEN provisions included
with the August 1, 2007 submittal. This approach allows EPA to
evaluate, for each provision, the cumulative revisions submitted by the
State on the dates specified above.
    A comprehensive summary of the Colorado APEN provisions in
Regulation Number 3, Part A, Section II, organized by EPA's proposed
rule action, is provided in Table 2 below. The APEN provision numbers
are as codified in the August 1, 2007 submission.

Table 2--List of Colorado APEN Provisions (Requirements and Exemption in
    Sections II.A through II.D of Part A, Regulation Number 3) by EPA
                          Proposed Rule Action
------------------------------------------------------------------------
                                     APEN provision number in August 1,
       EPA's proposed action                   2007 submission
------------------------------------------------------------------------
Approval--Substantially Revised     II.A; II.B.1.b; II.B.3; II.B.3.a;
 Provisions.                         II.C.1.h; II.C.2.b.(ii); II.C.3.c;
                                     II.C.3.d; II.D.1;
                                    II.D.1.a; II.D.1.f; II.D.1.g;
                                     II.D.1.i; II.D.1.nn; II.D.1.oo;
                                     II.D.1.ccc; II.D.1.fff; II.D.1.lll;
                                    II.D.1.nnn. through II.D.1.qqq;
                                     II.D.1.rrr; II.D.1.vvv; II.D.1.www;
                                     II.D.1.yyy through II.D.1.dddd;
                                    II.D.4. through II.D.6.
Approval--Provisions with Clerical  II.B.1; II.B.2; II.B.4.a. through
 Revisions.                          II.B.4.f; II.C. through II.C.1.a;
                                     II.C.2;
                                    II.C.2.b; II.C.2.b.(i);
                                     II.C.2.b.(iii). through II.C.3.b;
                                     II.D; II.D.1.h; II.D.1.j; II.D.1.k;
                                    II.D.1.n; II.D.1.x; II.D.1.y;
                                     II.D.1.aa; II.D.1.bb; II.D.1.kk;
                                     II.D.1.aaa;
                                    II.D.1.bbb; II.D.1.ggg; II.D.2;
                                     II.D.3.
Disapproval--Substantially Revised  II.D.1.q; II.D.1.sss; II.D.1.ttt;
 Provisions.                         II.D.1.xxx; II.D.1.ffff.
No Action--EPA's Prior Proposed     II.D.1.m; II.D.1.ee; II.D.1.uu;
 Action.                             II.D.1.ddd; II.D.1.uuu;
                                     II.D.1.eeee.
No Action--Un-Revised Provisions..  II.B; II.B.1.a; II.B.3.b; II.B.4;
                                     II.B.5; II.B.6; II.C.1.b. through
                                     II.C.1.g;
                                    II.C.2.a; II.D.1.b. through
                                     II.D.1.e; II.D.1.i.(i). through
                                     II.D.1.i.(iii); II.D.1.l;
                                    II.D.1.o; II.D.1.p; II.D.1.r.
                                     through II.D.1.w; II.D.1.z;
                                     II.D.1.cc; II.D.1.dd;
                                    II.D.1.ff. through II.D.1.jj;
                                     II.D.1.ll; II.D.1.mm; II.D.1.pp.
                                     through II.D.1.tt;
                                    II.D.1.vv. through II.D.1.zz;
                                     II.D.1.eee; II.D.1.hhh. through
                                     II.D.1.kkk;
                                    II.D.1.mmm.
------------------------------------------------------------------------

    In addition, EPA is proposing approval of certain other deletion
and renumbering of APEN requirements. The provisions (using the
numbering from the EPA-approved SIP, effective February 21, 1997) that
are proposed for deletion are: II.B.8., II.B.10., and II.D.4.b.
Deletion of the exemptions in II.D.4.b. makes the SIP more stringent,
and deletion of the other provisions does not impact APEN requirements
and exemptions, nor any other SIP provisions. EPA therefore proposes to
approve these deletions. EPA's proposed approval of the renumbering of
APEN requirements will be for the entirety of the language and their
new location in Section I.B. The provision references, before the
renumbering, were: II.B.5. and II.B. 9. The references, after the
renumbering, are, respectively: I.B.43 and I.B.16. The renumbering of
these provisions does not impact APEN requirements and exemptions, nor
any other SIP provisions.
    As indicated in the Background section of this action, for each of
the APEN provisions in Regulation Number 3, Part A, Sections II.A.
through II.D., EPA's TSD identifies the cumulative revisions (if any)
submitted by the State between 1997 and 2007, provides its assessment
of the revisions within the regulatory context referenced earlier in
this action, and indicates EPA's proposed action (approval, no action,
or disapproval.)

VII. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Volatile
Organic Compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: January 13, 2011.
Carol Rushin,
Acting Regional Administrator, Region 8.
[FR Doc. 2011-1477 Filed 1-24-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 93 (Tuesday, May 14, 2013)]
[Notices]
[Pages 28228-28229]
[FR Doc No: 2013-11361]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0057]

Guidance for Industry and Food and Drug Administration Staff on
Best Practices for Conducting and Reporting Pharmacoepidemiologic
Safety Studies Using Electronic Healthcare Data; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry and FDA staff entitled ``Best
Practices for Conducting and Reporting Pharmacoepidemiologic Safety
Studies Using Electronic Healthcare Data.'' The guidance is intended to
describe best practices pertaining to conducting and documenting
pharmacoepidemiologic safety studies that use electronic healthcare
data. The guidance includes recommendations for documenting the design,
analysis, and results of such studies to optimize FDA's review of
protocols and final reports that are submitted to the Agency.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448. The guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA 305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Regarding human drug products: Judy Staffa, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 274, Silver Spring, MD 20993-0002.
    Regarding human biological products: Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration (HFM-
17), 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-
827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Best Practices for Conducting and Reporting
Pharmacoepidemiologic Safety Studies Using Electronic Healthcare
Data.'' The primary goals of this guidance are to provide the
following:
     Consistent guidance for industry and FDA to use when
designing, conducting, and analyzing pharmacoepidemiologic safety
studies;
     A framework for industry to use when submitting
pharmacoepidemiologic safety study protocols and final reports to FDA;
and
     A framework for FDA reviewers to use when reviewing and
interpreting pharmacoepidemiologic safety study protocols and final
reports.
    This guidance does not address real-time active safety surveillance
studies, as this field is still rapidly evolving, and it is not
possible at this time to recommend sound best practices. The guidance
is not intended to be prescriptive with regard to choice of study
design or type of analysis and does not endorse any particular type of
data resource or methodology. Finally, the guidance does not provide a
framework for determining the appropriate weight of evidence to be
given to studies from this data stream in the overall assessment of
drug safety, as this appraisal represents a separate aspect of the
regulatory decision-making process and is best accomplished in the
context of the specific safety issue under investigation.
    In the Federal Register of February 16, 2011 (76 FR 9027), FDA
issued a draft version of this guidance entitled ``Best Practices for
Conducting and Reporting Pharmacoepidemiologic Safety Studies Using
Electronic Healthcare Data Sets.'' The comment period on the draft
guidance ended on April 18, 2011. Most of the comments sought
clarification and further illustrations of issues discussed in the
guidance. FDA has carefully reviewed all comments received on the draft
guidance (more than 400 comments were submitted to the public docket).
As a result of the public comments, FDA has clarified the following
sections of the guidance: Interpretation of findings; study time frame;
identification and handling of confounding and the use of statistical
techniques to address confounding; exposure ascertainment; study
design; outcome definition and validation; prespecified analysis plan;
and the linkage and pooling of data from different data sources.
Glossary definitions and references were added to different sections of
the guidance to clarify terms and cite additional resources.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on best practices for conducting and
reporting pharmacoepidemiologic safety studies using electronic
healthcare data. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    This guidance provides best practices for reporting
pharmacoepidemiologic safety studies using electronic healthcare data.
The reports referenced in the guidance would be submitted under 21 CFR
314.81, 314.98, and 601.70. These collections of information are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and are
approved under OMB control numbers 0910-0001 and 0910-0338.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/

Guidances/default.htm, or http://www.regulations.gov.

    Dated: May 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11361 Filed 5-13-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 71 (Friday, April 12, 2019)]
[Notices]
[Pages 15009-15011]
[FR Doc No: 2019-07239]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85542; File No. SR-CboeBYX-2019-003]

Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Extend
the Current Pilot Program Related to BYX Rule 11.17, Clearly Erroneous
Executions

April 8, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 2, 2019, Cboe BYX Exchange, Inc. (``Exchange'' or ``BYX'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Exchange filed the proposal as
a ``non-controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    Cboe BYX Exchange, Inc. (``BYX'' or the ``Exchange'') is filing
with the Securities and Exchange Commission (the ``Commission'') a
proposed rule change to extend the current pilot program related to BYX
Rule 11.17, Clearly Erroneous Executions, to the close of business on
October 18, 2019 The text of the proposed rule change is attached as
Exhibit 5. [sic]
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/byx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange 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 Exchange 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 of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to extend the current
pilot program related to BYX Rule 11.17, Clearly Erroneous Executions,
to the close of business on October 18, 2019. This change is being
proposed in connection with proposed amendments to the Plan to Address
Extraordinary Market Volatility (the ``Limit Up-Limit Down Plan'' or
the ``Plan'') that would allow the Plan to continue to operate on a
permanent basis.\5\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 84843 (December 18,
2018), 83 FR 66464 (December 26, 2018) (File No. 4-631)
(``Eighteenth Amendment'').
---------------------------------------------------------------------------

    On October 4, 2010, the Exchange filed an immediately effective
filing to make a number of changes to BYX rules to bring those rules up
to date with the changes that had been made to the rules of the
Exchange's affiliate, BATS Exchange, Inc. (n/k/a Cboe BZX Exchange,
Inc.), while BYX's Form 1 application to register as a national
security exchange was pending approval. Such changes included changes
made, on a pilot basis, to BYX Rule 11.17, that, among other things:
(i) Provided for uniform treatment of clearly
erroneous[thinsp]execution reviews in multi-stock events involving
twenty or more securities; and (ii) reduced the ability of the Exchange
to deviate from the objective standards set forth in the rule.\6\ In
2013, the Exchange adopted a provision designed to address the
operation of the Plan.\7\ Finally, in 2014, the Exchange adopted two
additional provisions providing that: (i) A series of transactions in a
particular security on one or more trading days may be viewed as one
event if all such transactions were effected based on the same
fundamentally incorrect or grossly misinterpreted issuance information
resulting in a severe valuation error for all such transactions; and
(ii) in the event of any disruption or malfunction in the operation of
the electronic communications and trading facilities of an Exchange,
another SRO, or responsible single plan processor in connection with
the transmittal or receipt of a trading halt, an Officer, acting on his
or her own motion, shall nullify any transaction that occurs after a
trading halt has been declared by the primary listing market for a
security and before such trading halt has officially ended according to
the primary listing market.\8\ These changes are currently scheduled to
operate for a pilot period that coincides with the pilot period for the
Limit Up-Limit Down Plan,\9\ including any extensions to the pilot
period for the Plan.\10\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 63097 (Oct. 13,
2010), 75 FR 64767 (Oct. 20, 2010) (SR-BYX-2010-002).
    \7\ See Securities Exchange Act Release No. 68798 (Jan. 31,
2013), 78 FR 8628 (Feb. 6, 2013) (SR-BYX-2013-005).
    \8\ See Securities Exchange Act Release No. 72434 (June 19,
2014), 79 FR 36110 (June 25, 2014) (SR-BYX-2014-007).
    \9\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012) (the ``Limit Up-Limit Down
Release'').
    \10\ See Securities Exchange Act Release No. 71796 (March 25,
2014), 79 FR 18099 (March 31, 2014) (SR-BYX-2014-003).
---------------------------------------------------------------------------

    The Commission recently published the proposed Eighteenth Amendment
to the Plan to allow the Plan to operate on a permanent, rather than
pilot, basis. The Exchange proposes to amend BYX Rule 11.17 to untie
the pilot program's effectiveness from that of the Plan and to extend
the pilot's effectiveness to the close of business on October 18,
2019--i.e., six months after the expiration of the current pilot period
for the Plan. If the pilot period is not either extended, replaced or
approved as permanent, the prior versions of paragraphs (c), (e)(2),
(f), and (g) shall be in effect, and the provisions of paragraphs (i)
through (k) shall be null and void.\11\ In such an event, the remaining
sections of BYX Rule 11.17 would continue to apply to all transactions
executed on the Exchange. The Exchange understands that the other
national securities exchanges and Financial Industry Regulatory
Authority (``FINRA'') will also file similar proposals to extend their
respective clearly erroneous execution pilot programs, the substance of
which are identical to BYX Rule 11.17.
---------------------------------------------------------------------------

    \11\ See supra notes 6-8. The prior versions of paragraphs (c),
(e)(2), (f), and (g) in effect before the 2010 changes to the rule
generally provided greater discretion to the Exchange with respect
to breaking erroneous trades.
---------------------------------------------------------------------------

    The Exchange does not propose any additional changes to BYX Rule
11.17. The Exchange believes the benefits to market participants from
the more objective clearly erroneous executions rule should continue on
a limited six month pilot basis after Commission approves the Plan to
operate on a permanent basis. Assuming the Plan is approved by the
Commission to operate on a permanent, rather than pilot, basis the
Exchange intends to assess whether

additional changes should also be made to the operation of the clearly
erroneous execution rules. Extending the effectiveness of BYX Rule
11.17 for an additional six months should provide the Exchange and
other national securities exchanges additional time to consider further
amendments to the clearly erroneous execution rules in light of the
proposed Eighteenth Amendment to the Plan.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the requirements of Section 6(b) of the Act,\12\ in general, and
Section 6(b)(5) of the Act,\13\ in particular, in that it is designed
to remove impediments to and perfect the mechanism of a free and open
market and a national market system, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest and not to permit unfair discrimination between
customers, issuers, brokers, or dealers. The Exchange believes that the
proposed rule change promotes just and equitable principles of trade in
that it promotes transparency and uniformity across markets concerning
review of transactions as clearly erroneous. The Exchange believes that
extending the clearly erroneous execution pilot under BYX Rule 11.17
for an additional six months would help assure that the determination
of whether a clearly erroneous trade has occurred will be based on
clear and objective criteria, and that the resolution of the incident
will occur promptly through a transparent process. The proposed rule
change would also help assure consistent results in handling erroneous
trades across the U.S. equities markets, thus furthering fair and
orderly markets, the protection of investors and the public interest.
Based on the foregoing, the Exchange believes the amended clearly
erroneous executions rule should continue to be in effect on a pilot
basis while the Exchange and the other national securities exchanges
consider and develop a permanent proposal for clearly erroneous
execution reviews.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposal would ensure
the continued, uninterrupted operation of harmonized clearly erroneous
execution rules across the U.S. equities markets while the Exchange and
other national securities exchanges consider further amendments to
these rules in light of the proposed Eighteenth Amendment to the Plan.
The Exchange understands that the other national securities exchanges
and FINRA will also file similar proposals to extend their respective
clearly erroneous execution pilot programs. Thus, the proposed rule
change will help to ensure consistency across market centers without
implicating any competitive issues.

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

    No comments were solicited or received on the proposed rule change.

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

    Because the foregoing 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)(iii) of the Act \14\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\15\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization 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 date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \16\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \17\ permits the Commission to
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 proposed
rule change may become effective and operative immediately upon filing.
The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest, as
it will allow the current clearly erroneous execution pilot program to
continue uninterrupted, without any changes, while the Exchange and the
other national securities exchanges consider and develop a permanent
proposal for clearly erroneous execution reviews. For this reason, the
Commission hereby waives the 30-day operative delay and designates the
proposed rule change as operative upon filing.\18\
---------------------------------------------------------------------------

    \16\ 17 CFR 240.19b-4(f)(6).
    \17\ 17 CFR 240.19b-4(f)(6)(iii).
    \18\ 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: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) 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 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 protected]. Please include
File Number SR-CboeBYX-2019-003 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-CboeBYX-2019-003. 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-
CboeBYX-2019-003 and should be submitted on or before May 3, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-07239 Filed 4-11-19; 8:45 am]
 BILLING CODE 8011-01-P