[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)]
[Notices]
[Pages 45653-45656]
[FR Doc No: 2017-20891]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81716; File No. SR-NYSEAMER-2017-10]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Rule 928NY To Allow Certain Order Types To Be Excluded From the Risk
Limitation Mechanism

September 25, 2017.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act''),\2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on September 11, 2017, NYSE American LLC (the ``Exchange''
or ``NYSE American'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend Rule 928NY (Risk Limitation
Mechanism) to allow certain order types to be excluded from the risk
limitation mechanism. The proposed rule change is available on the
Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, 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 self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to amend Rule 928NY (Risk Limitation
Mechanism) to allow certain order types to be excluded from the risk
limitation mechanism. Specifically, the Exchange proposes to provide
ATP Holders with the option to exclude Immediate-Or-Cancel (``IOC'')
orders from being counted against risk limitation thresholds.\4\
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    \4\ An IOC order is ``[a] Limit Order that is to be executed in
whole or in part on the Exchange as soon as such order is received,
and the portion not so executed is to be canceled.'' See Rule
900.3NY(k).
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Risk Limitation Mechanisms
    The Exchange offers ATP Holders the option of utilizing risk
limitation settings to assist ATP Holders in managing risk related to
submitting orders during periods of increased and significant trading
activity.\5\ An ATP Holder can utilize one of three risk limitation
mechanisms for its orders--based on the number of transactions
executed, the number of contracts traded, or the percent of the ATP
Holder's order size--which automatically cancels such orders when
certain parameter settings are breached.\6\ The Exchange maintains
trade counters that increment based on the number of trades executed,
either from a single-leg order or any leg of a Complex Order, in any
series in a specified class.\7\ The trade counters reset after an
Exchange-determined time period.\8\ When an ATP Holder has breached its
risk settings (i.e., has traded more than the contract or volume limit
or cumulative percentage limit of a class during the specified
measurement interval), the Exchange will cancel all of the ATP Holder's
open orders in that class until the ATP Holder notifies the Exchange it
will resume submitting orders.\9\ The temporary suspension of orders
from the market that results when the risk settings are triggered is
meant to operate as a safety valve that enables ATP Holders to re-
evaluate their positions before requesting to re-enter the market.
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    \5\ See Commentary .04(b) to Rule 928NY (providing that ATP
Holders may avail themselves of one of the three risk limitation
mechanisms for certain of their orders). Under the current Rule,
Market Makers are required to utilize the risk limitation settings
for quotes and the Exchange is not proposing to alter any aspect of
this Rule in this regard. See also Commentary .04(a) to Rule 928NY;
and Rule 928NY(b)(2), (c)(2), (d)(2) and (e)(2).
    \6\ See 928NY(b)(1), (c)(1), (d)(1) and Commentaries .01 to Rule
928NY (regarding the cancellation of orders once the risk settings
have been breached).
    \7\ See Rule 928NY(a)(1), (f). See also Commentaries .05-.07 to
Rule 928NY (regarding the operation of the trade counters).
    \8\ See Commentary .06 to Rule 928NY.
    \9\ See Commentaries .01 and .02 to Rule 928NY (requiring that
an ATP Holder request that it be re-enabled after a breach of its
risk settings). In the event that an ATP Holder experiences
multiple, successive triggers of its risk settings, the Exchange
would cancel all of the open orders--as opposed to cancelling only
those in the option class (underlying symbol) in which the risk
settings were triggered. See Rule 928NY(f) and Commentary .02 to
Rule 928NY.
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Proposed Exclusion of IOC Orders From Risk Settings
    Under the current Rule, an ATP Holder may activate a Risk
Limitation Mechanism, and corresponding settings, for orders in a
specified class and, once activated, the mechanism and the settings
established will remain active unless, and until, the ATP Holder
deactivates the Risk Limitation Mechanism or changes the settings.\10\
Thus, once an ATP Holder activates risk settings for orders in a
specified class, the risk settings apply to all order types in that
options class. The Exchange proposes to modify the rule to provide an
ATP Holder that chooses to utilize risk settings for its orders the
option to exclude both single-legged orders and Complex Orders
designated as IOC from being considered by the trade counter. To effect
this change, proposed Commentary .07 to Rule 928NY would be amended to
provide that ``[a]ny ATP Holder that activates the Risk Limitation
Mechanisms for orders pursuant to Commentary .04(b) of this Rule may
opt to exclude any orders (i.e., whether single-leg orders or Complex
Orders) designated with a time-in-force of IOC from being considered by
a trade counter.'' \11\
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    \10\ See Commentary .04(b) to Rule 928NY.
    \11\ See proposed Commentary .07 to Rule 928NY. The Exchange
also proposes to correct a typographical error and make singular the
reference to Complex Orders in the sentence providing that
``[e]xecutions of each leg of a Complex Orders will be considered by
a trade counter as an individual transaction928NY.'' See id.
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    By their terms, IOC orders (or portions thereof) will cancel if not
immediately executed. As such, IOC orders are never ranked (as resting
interest) in the Consolidated Book. The Exchange believes that certain
OTPs [sic] utilize IOC orders to access liquidity on the Exchange.
Thus, the proposed change is designed to accommodate participants that
utilize IOCs in this manner by enabling them to exclude IOC orders from
being counted and avoid potentially triggering their risk settings
(prematurely), resulting in the cancellation of open orders. The
Exchange believes that providing ATP Holders this additional
flexibility may encourage more ATP Holders to utilize the risk
settings, which benefits all market participants. The Exchange also
believes that the proposed change would result in risk settings that
may be better calibrated to suit the needs of certain ATP Holders
(i.e., those that routinely utilize IOC orders to access liquidity on
the Exchange), which improved risk settings should encourage ATP
Holders to direct additional order flow and liquidity to the Exchange.
    The Exchange notes that the proposed change is limited to IOC
orders being counted towards whether a risk limitation threshold has
been reached. In the event an ATP Holder breaches its risk limitation
settings, any new orders in the specified class, including incoming IOC
orders, sent by the ATP Holder would be rejected until the ATP Holder
requests that the Exchange enable the entry of new orders.\12\
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    \12\ See Commentary .02 to Rule 928NY.
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Implementation
    The Exchange will announce by Trader Update the implementation date
of the proposed rule change, which implementation will be no later than
90 days after the effectiveness of this rule change.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Securities Exchange Act of 1934 (the ``Act''),\13\ in
general, and furthers the objectives of Section 6(b)(5) of the Act,\14\
in particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, 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.
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    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed rule change removes
impediments to and perfects the mechanism of a free and open market by
providing ATP Holders greater control and flexibility over setting
their risk tolerance, which may enhance the efficacy of the risk
settings. By their terms, IOC orders (or portions thereof) will cancel
if not immediately executed. As such, IOC orders are never ranked (as
resting interest) in the Consolidated Book. The Exchange believes that

certain market participants utilize IOC orders to access liquidity on
the Exchange. Thus, the proposed change is designed to accommodate
participants that utilize IOCs in this manner by enabling them to
exclude IOC orders from being counted and avoid potentially triggering
their risk settings (prematurely), resulting in the cancellation of
open orders. The Exchange believes that providing ATP Holders this
additional flexibility may encourage more ATP Holders to utilize the
risk settings, which benefits all market participants. Further, the
proposed change would promote just and equitable principles of trade
because it would result in risk settings that may be better calibrated
to suit the needs of certain OTPs [sic] (i.e., those that routinely
utilize IOC orders to access liquidity on the Exchange), which improved
risk settings should encourage ATP Holders to direct additional order
flow and liquidity to the Exchange. To the extent additional order flow
is submitted to the Exchange as a result of the proposed change, all
market participants stand to benefit from increased trading.\15\
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    \15\ The Exchange believes that the proposed correct of a
typographical error in current Commentary .07 to Rule 928NY (see
supra note 11) would add clarify [sic] and transparency to the Rule
which benefits investors and the public interest.
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    The Exchange notes that an ATP Holder has the option of utilizing
risk settings for all orders submitted to the Exchange and, as
proposed, would have the additional option of excluding from these risk
settings any IOC orders in a given options class submitted to the
Exchange.
    This proposed change, which was specifically requested by some ATP
Holders, would foster cooperation and coordination with persons engaged
in regulating, clearing, settling, and processing information with
respect to, and facilitating transactions in, securities as it will be
available to all OTPs [sic] on an optional basis and may encourage more
ATP Holders to utilize this enhanced functionality to [sic] benefit of
all market participants. Because the risk controls are designed to
prevent the execution of erroneously priced trades, the Exchange
believes that any proposal designed to increase the number of ATP
Holders that utilize the functionality would benefit all market
participants.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange is proposing a
market enhancement that would provide ATP Holders with greater control
and flexibility over setting their risk tolerance and, potentially,
more protection over risk exposure. The proposal is structured to offer
the same enhancement to all ATP Holders, regardless of size, and would
not impose a competitive burden on any participant. The Exchange does
not believe that the proposed enhancement to the existing risk
limitation mechanism would impose a burden on competing options
exchanges. Rather, the availability of this mechanism may foster more
competition. Specifically, the Exchange notes that it operates in a
highly competitive market in which market participants can readily
favor competing venues. When an exchange offers enhanced functionality
that distinguishes it from the competition and participants find it
useful, it has been the Exchange's experience that competing exchanges
will move to adopt similar functionality. Thus, the Exchange believes
that this type of competition amongst exchanges is beneficial to the
market place [sic] as a whole as it can result in enhanced processes,
functionality, and technologies.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \16\ and Rule 19b-4(f)(6) thereunder.\17\
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    \16\ 15 U.S.C. 78s(b)(3)(A).
    \17\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the 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.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \18\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \19\ 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 Exchange can implement the proposal without delay. The Exchange
believes that waiver of the operative delay would be consistent with
the protection of investors and the public interest because it would
enable the Exchange to implement without delay the proposed optional
functionality, which the Exchange believes may, in turn, encourage more
ATP Holders to utilize the optional risk settings for orders. Thus, the
Exchange believes waiver of the operative delay would protect investors
by enabling the Exchange to provide greater flexibility to its Risk
Limitation Mechanisms for orders, which may result in increased usage
of the risk settings to the benefit of all market participants. The
Commission believes that waiver of the operative delay is consistent
with the protection of investors and the public interest because it
will provide ATP Holders with the flexibility to exclude IOC orders
from consideration by a trade counter, which, the Exchange believes,
could encourage additional ATP Holders to use the risk limitation
settings. As noted above, the risk limitation settings are designed to
assist ATP Holders in managing risk related to submitting orders during
periods of increased and significant trading activity. Under the
proposal, the ability to exclude IOC orders from consideration by a
trade counter is optional; thus, an ATP Holder that utilizes the risk
limitation settings and wishes to continue to have its IOC orders
considered by a trade counter will be able to do so. Accordingly, the
Commission hereby waives the operative delay and designates the
proposed rule change operative upon filing.\20\
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    \18\ 17 CFR 240.19b-4(f)(6).
    \19\ 17 CFR 240.19b-4(f)(6)(iii).
    \20\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings

to determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAMER-2017-10 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEAMER-2017-10. 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 Web site (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 Web site 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 such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEAMER-2017-10, and should
be submitted on or before October 20, 2017.
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    \21\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-20891 Filed 9-28-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Proposed Rules]
[Pages 15985-15989]
[FR Doc No: 2012-6561]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2011-0866; FRL-9649-3]

Approval and Promulgation of Air Quality Implementation Plans;
Maryland; Preconstruction Requirements-Prevention of Significant
Deterioration and Nonattainment New Source Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve several revisions to the Maryland
State Implementation Plan (SIP) submitted by the Maryland Department of
the Environment (MDE). These revisions pertain to preconstruction
requirements under the Prevention of Significant Deterioration (PSD)
and non-attainment New Source Review (NSR) programs. The proposed SIP
revisions will satisfy the following required SIP elements: NSR Reform,
NOX as a precursor to ozone, PM2.5, and
Greenhouse Gases (GHGs). Additionally, EPA is proposing, as a separate
action, to approve Maryland's submittals for purposes of meeting the
infrastructure requirements of the Clean Air Act (CAA) which relate to
Maryland's PSD permitting program and are necessary to implement,
maintain, and enforce the 1997 8-hour ozone and PM2.5
National Ambient Air Quality Standards (NAAQS) and the 2006
PM2.5 NAAQS. This action is being taken under the CAA.

DATES: Written comments must be received on or before April 18, 2012.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2011-0866 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2011-0866, Kathleen Cox, Associate Director,
Office of Permits and Air Toxics, Mailcode 3AP10, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2011-0866. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at 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 www.regulations.gov or email. The
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 email comment
directly to EPA without going through www.regulations.gov, your email
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.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be

publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Maryland Department of the Environment, 1800
Washington Boulevard, Suite 705, Baltimore Maryland 21230.

FOR FURTHER INFORMATION CONTACT: David Talley,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. On the dates described in
detail below, MDE submitted revisions to its SIP for the PSD and
nonattainment NSR programs.

I. Background

    Today's action proposes the simultaneous approval of three separate
SIP revision requests submitted by MDE, as described below. Approval of
these actions will have several significant impacts. It will
incorporate for the first time, EPA's 2002 ``NSR Reform'' provisions
into Maryland's non-attainment NSR and PSD programs. It will correct
deficiencies identified by EPA in the March 27, 2008 Federal Register
notice entitled, ``Completeness Findings for Section 110(a) State
Implementation Plans for the 8 hour Ozone National Ambient Air Quality
Standards (1997 Ozone NAAQS)'', (73 FR 16205), by regulating
NOX as a precursor to ozone. It will ensure that GHGs in
Maryland are regulated in a manner consistent with federal regulations.
Additionally, these proposed SIP Revisions, along with previously
approved SIP revisions relating to Maryland's federally enforceable PSD
program, support a finding that Maryland has met its statutory
obligations pursuant to CAA section 110(a)(2) which relate to CAA Title
I, Part C requirements, including, but not limited to, relevant
portions of sections 110(a)(2)(C), (D)(i)(II) and (J).

A. SIP Revision 07-13

    On October 24, 2007 MDE submitted a SIP revision request to EPA
which included amendments to Regulations .01-.03, repeal of existing
Regulations .04 and .05, and the adoption of new Regulations .04--.09
under COMAR 26.11.17, Nonattainment Provisions for Major New Sources
and Major Modifications. This SIP submittal revises the previously-
approved versions of these rules as approved into the Maryland SIP on
February 12, 2001 for COMAR 26.11.17 Regulations .02, .04, and .05 (66
FR 9766) and September 20, 2004 for COMAR 26.11.17 Regulations .01 and
.03 (69 FR 56170). These amendments were adopted by Maryland on
September 18, 2007 and became effective on October 22, 2007. The State
adopted these regulations in order to meet the relevant plan
requirements of Title 40 of the Code of Federal Regulations (CFR) Sec.
51.165 and the CAA. The MDE is now seeking approval of these
amendments.

B. SIP Revision 09-03

    On July 31, 2009, MDE submitted a SIP revision request to EPA that
consisted of the incorporation by reference of the Federal PSD
requirements at 40 CFR 52.21 as codified in the July 1, 2008 edition of
the CFR. The SIP revision request included amendments to the MDE
Regulation .01 under COMAR 26.11.01 (General Administrative Provisions)
and Regulation .14 under COMAR 26.11.06 (General Emission Standards,
Prohibitions, and Restrictions). On June 23, 2011, MDE submitted a
letter, retracting the part of submission 09-03 which updated
the incorporation by reference date. Since originally submitting
09-03, Maryland has adopted the federal regulations as they
appear in the July 1, 2009 version of the CFR (See State Submission
11-02, below). Today's action proposes approval of only that
part of the submission which clarifies the definitions of
``Administrator'' and ``reviewing authority''.
    This SIP submittal revises the previously-approved versions of
these rules as approved into the Maryland SIP on May 28, 2002 (67 FR
36810). These amendments were adopted by Maryland on June 11, 2009 and
became effective on July 16, 2009. The State adopted these regulations
in order to meet the relevant plan requirements of 40 CFR 51.166 and
the CAA. The MDE is now seeking approval of these amendments.

C. SIP Revision 11-02

    On June 23, 2011, MDE submitted a SIP revision request to EPA that
consisted of the incorporation by reference of the federal PSD
requirements at 40 CFR 52.21 as codified in the July 1, 2009 edition of
the CFR, as well as the incorporation of the revisions to 40 CFR 52.21
promulgated on May 13, 2010 in the Greenhouse Gas Tailoring Rule (75 FR
31514). The SIP revision request included amendments to the MDE
Regulation .01 under COMAR 26.11.01 (General Administrative
Provisions), Regulations .01 and .12 under COMMAR 26.11.02 (Permits,
Approvals, and Registration), and Regulation .14 under COMAR 26.11.06
(General Emission Standards, Prohibitions, and Restrictions).
    This SIP submittal revises the previously-approved versions of
these rules, approved as follows: COMAR <IP_ADDRESS> and COMAR
<IP_ADDRESS> were adopted into the Maryland SIP on May 28, 2002 (67 FR
36810). COMAR <IP_ADDRESS> and .12 were adopted into the Maryland SIP on
February 27, 2003 (68 FR 9012). These amendments were adopted by
Maryland on April 14, 2011 and became effective on May 16, 2009. The
State adopted these regulations in order to meet the relevant plan
requirements of 40 CFR 51.166 and the CAA. The MDE is now seeking
approval of these amendments.

II. Analysis

A. NSR Reform

1. History
    On December 31, 2002 (67 FR 80186), EPA published final rule
changes to 40 CFR parts 51 and 52, regarding the CAA's PSD and
Nonattainment NSR programs. On November 7, 2003 (68 FR 63021), EPA
published a notice of final action on the reconsideration of the
December 31, 2002, final rule changes. The December 31, 2002, and the
November 7, 2003, final actions are collectively referred to as ``NSR
Reform.'' The purpose of this action is to propose to approve the SIP
submittals from the State of Maryland that include State rule changes
made as a result of EPA's 2002 NSR Reform Rules.
    The 2002 NSR Reform Rules are part of EPA's implementation of parts
C and D of title I of the CAA. Part C of title I of the CAA is the PSD
program, which applies in areas that meet the NAAQS (``attainment''
areas), as well as in areas for which there is insufficient information
to determine whether the area meets the NAAQS (``unclassifiable''
areas). Part D of title I of the CAA is the nonattainment NSR program,
which applies in areas that are not in attainment of the NAAQS
(``nonattainment'' areas). Collectively, the PSD and nonattainment NSR
programs are referred to as the ``New Source Review'' or NSR programs.
EPA regulations implementing these programs are contained in 40 CFR
51.165, 51.166, 52.21, 52.24, and part 51, appendix S.
    The CAA's NSR programs are preconstruction review and permitting
programs applicable to new and

modified stationary sources of air pollutants regulated under the CAA.
The NSR programs of the CAA include a combination of air quality
planning and air pollution control technology program requirements.
Briefly, section 109 of the CAA requires EPA to promulgate primary
NAAQS to protect public health and secondary NAAQS to protect public
welfare. Once EPA sets those standards, states must develop, adopt, and
submit to EPA for approval a SIP that contains emissions limitations
and other control measures to attain and maintain the NAAQS. Each SIP
is required to contain a preconstruction review program for the
construction and modification of any stationary source of air pollution
to assure that the NAAQS are achieved and maintained; to protect areas
of clean air; to protect air quality related values (such as
visibility) in national parks and other areas; to assure that
appropriate emissions controls are applied; to maximize opportunities
for economic development consistent with the preservation of clean air
resources; and to ensure that any decision to increase air pollution is
made only after full public consideration of the consequences of the
decision.
    The 2002 NSR Reform Rules made changes to five areas of the NSR
programs. In summary, the 2002 Rules: (1) Provided a new method for
determining baseline actual emissions; (2) adopted an actual-to-
projected-actual methodology for determining whether a major
modification has occurred; (3) allowed major stationary sources to
comply with a Plantwide Applicability Limit (PAL) to avoid having a
significant emissions increase that triggers the requirements of the
major NSR program; (4) provided a new applicability provision for
emissions units that are designated clean units; and (5) excluded
pollution control projects (PCPs) from the definition of ``physical
change or change in the method of operation.'' On November 7, 2003 (68
FR 63021), EPA published a notice of final action on its
reconsideration of the 2002 NSR Reform Rules, which added a definition
for ``replacement unit'' and clarified an issue regarding PALs. For
additional information on the 2002 NSR Reform Rules, see 67 FR 80186
(December 31, 2002), and http://www.epa.gov/nsr.
    After the 2002 NSR Reform Rules were finalized and effective (March
3, 2003), industry, state, and environmental petitioners challenged
numerous aspects of the 2002 NSR Reform Rules, along with portions of
EPA's 1980 NSR Rules (45 FR 52676, August 7, 1980). On June 24, 2005,
the United States Court of Appeals for the District of Columbia (DC
Circuit Court) issued a decision on the challenges to the 2002 NSR
Reform Rules. New York v. United States, 413 F.3d 3 (New York I). In
summary, the DC Circuit Court vacated portions of the rules pertaining
to clean units and PCPs, remanded a portion of the rules regarding
recordkeeping and the term ``reasonable possibility'' found in 40 CFR
52.21(r)(6) and 40 CFR 51.166(r)(6), and either upheld or did not
comment on the other provisions included as part of the 2002 NSR Reform
Rules. On June 13, 2007 (72 FR 32526), EPA took final action to revise
the 2002 NSR Reform Rules to remove from federal law all provisions
pertaining to clean units and the PCP exemption that were vacated by
the DC Circuit Court.
    With regard to the remanded portions of the 2002 NSR Reform Rules
related to recordkeeping, on December 21, 2007, EPA took final action
to establish that a ``reasonable possibility'' applies where source
emissions equal or exceed 50 percent of the CAA NSR significance levels
for any pollutant (72 FR 72607). The ``reasonable possibility''
provision identifies for sources and reviewing authorities the
circumstances under which a major stationary source undergoing a
modification that does not trigger major NSR must keep records.
    Finally, on January 19, 2010, EPA denied a petition from the
Natural Resources Defense Council (NRDC) and Sierra Club requesting EPA
to reconsider and stay the Wisconsin Department of Natural Resources
SIP revision that incorporated EPA's New Source Review Reforms of 2002.
Petitioners submitted comments arguing that these NSR Reform provisions
were ``backsliding'', and thus prohibited under CAA sections 110(l) and
193. EPA approved the Wisconsin SIP revisions and addressed
Petitioners' arguments about backsliding by (1) noting that the
provisions had been upheld by the New York I court, (2) that the
general analysis that EPA had done to support the 2002 rule supported
NSR Reform in Wisconsin, and (3) Petitioners had not provided any
information or arguments demonstrating that the general analysis did
not apply in Wisconsin, and that information in the record countered
Petitioners' specific arguments that the revisions would be
backsliding. Additionally, in response to comments, EPA performed an
analysis specific to Wisconsin to examine the impacts of applying
reform in that State. Our findings were consistent with those of the
supplementary environmental analysis (SEA) for the 2002 Reform Rule
(neutral).
    NRDC v. Jackson: On June 16, 2011, the U.S. Court of Appeals for
the Seventh Circuit (Seventh Circuit) denied the petitions for review
filed by NRDC and Sierra Club challenging EPA's approval of the 2002
NSR Reform provisions into the Wisconsin SIP. The primary issue
addressed in the opinion was whether EPA's approval of Wisconsin's NSR
SIP was backsliding prohibited by CAA sections 110(l) and 193. The
Court held that EPA's decision was not contrary to these provisions.
First, the Court found that Petitioners' arguments were a repeat of the
arguments that they had made and lost in New York I. Second, the Court
held that the general analysis that supported the NSR Reform provisions
when they were challenged after promulgation ``supply substantial
evidence for the EPA's decision [with respect to the Wisconsin SIP] and
show that it is neither arbitrary nor capricious.'' But, the Court did
note that some states have implemented the NSR Reform provisions and
that the experience in those states might support or refute EPA's
conclusions and that ``[a]t some point, preferring predictions over
facts is no longer rational.''
2. Analysis
    The 2002 NSR Reform Rules required that state agencies adopt and
submit revisions to their SIP permitting programs implementing the
minimum program elements of the 2002 NSR Reform Rules no later than
January 2, 2006 (consistent with changes to 40 CFR 51.166(a)(6)(i),
state agencies are now required to adopt and submit SIP revisions
within three years after new amendments are published in the Federal
Register). State agencies may meet the requirements of 40 CFR part 51
and the 2002 NSR Reform Rules with different but equivalent
regulations. For the purposes of PSD, Maryland has incorporated by
reference 40 CFR 52.21. For non-attainment NSR, the State has adopted
regulations that in most respects track the federal rules. The proposed
SIP revisions include only those provisions which were upheld by the DC
Circuit in 2005, and reaffirmed in the Seventh Circuit's denial of the
petition to reconsider EPA's approval of NSR Reform into Wisconsin's
SIP (NRDC v. Jackson).
    With respect to Maryland's nonattainment NSR rules, a line-by-line
comparison indicates that they vary from the federal 2002 NSR Reform
rules in insignificant ways. For instance, the State's definition of
``baseline actual emissions'' for sources other than electric steam
generating facilities has a five-year presumptive ``look-back''

period, but allows a facility to request up to a 10 year look-back
period if it is more representative of actual source operations. In
addition, PALs are limited to a five year effective date, rather than
ten years as allowed in the federal rules. As noted above, states may
have different but equivalent rules and in this regard, it is clear
that Maryland's nonattainment NSR rules contain the basic elements for
implementing NSR reform.
    Section 110(l) of the CAA prohibits the approval of a SIP revision
which would interfere with any applicable requirement concerning
attainment and reasonable further progress or any other applicable
requirement of the CAA. EPA has determined that approval of the
proposed revisions to COMAR 26.11.17 and the incorporation of 40 CFR
52.21 will not violate section 110(l). The inherent checks and balances
afforded by the CAA have been maintained, including the independent
obligation for attainment of the NAAQS. Nevertheless, the Seventh
Circuit, in upholding EPA's approval of the Wisconsin NSR SIP rules,
cautioned that predictions made when these rules were promulgated
should no longer be relied upon to demonstrate that NSR Reform is not a
relaxation of the SIP. In fact, the proposed regulations have been in
effect in Maryland since 2007, and several states, including Georgia,
New York, and North Carolina have had the NSR Reform regulations
approved into their SIPs with no known link between reform and a
decrease in air quality or an interference with reasonable further
progress. This is not unexpected given the limited universe of affected
sources. NSR Reform only affects permitting of modifications to
existing sources, and more specifically, modifications to existing
emissions units. Any growth occurring from new, greenfield sites would
be controlled and permitted the same both pre- and post-reform.
Therefore, any concerns about NSR Reform would be related to
unregulated growth from existing major sources. In the specific case of
Maryland, the State maintains a robust minor NSR program that
specifically regulates minor changes to major stationary sources. So
while a facility may escape the requirements of major NSR, they do not
escape the requirement to obtain a pre-construction permit that
includes the requirement to monitor emissions after a change and may
also include an air quality impact analysis. Finally, Maryland's
demonstration of reasonable further progress for nonattainment areas
does not rely on this NSR rule, but on other control requirements such
as Reasonably Available Control Technology (RACT).
    As noted above, EPA took final action in December of 2007 to
promulgate the ``reasonable possibility'' provisions which had been
remanded by the DC Circuit in 2005 in New York I. These are
recordkeeping and reporting requirements for major stationary sources
undergoing minor modifications. These requirements are included in the
PSD regulations that Maryland has incorporated by reference. However,
because Maryland's proposed non-attainment regulations were effective
and submitted to EPA in October of 2007, the submittal does not include
the ``reasonable possibility'' requirements promulgated on December 21,
2007 (72 FR 72607). While these provisions are a required minimum
program element, we note that in the preamble to the final rule, we
acknowledge that ``State and local authorities may adopt or maintain
NSR program elements that have the effect of making their regulations
more stringent than these rules.'' (72 FR 72614). Maryland maintains a
robust minor NSR program, with recording keeping and reporting
requirements that are more stringent than the ``reasonable
possibility'' requirements. As further discussed in the preamble,
``Minor NSR programs by definition apply to emissions increases less
than the major NSR significant level, and only activities that a State
qualifies as `insignificant activities' under the SIP-approved program
may be excluded from review. Thus, reviewing authorities have an
opportunity to review virtually all projects causing an emissions
increase before construction begins. Moreover, our regulations (40 CFR
51.161) provide for public review of information submitted by owners/
operators for purposes of minor NSR review. Thus, information provided
for purposes of minor NSR programs is also of value in determining
applicability of major NSR'' (See 72 FR 72613). On December 6, 2001,
MDE submitted a letter acknowledging that the SIP approved regulations
under COMAR 26.11.02 fulfill the requirements of 40 CFR 51.165 (a)(6)
and (a)(6)(vi). This letter is included in the docket for the proposed
rulemaking.

B. NOX as a Precursor to Ozone

    This SIP submission corrects a deficiency identified by EPA in the
March 27, 2008 Federal Register action entitled, ``Completeness
Findings for Section 110(a) State Implementation Plans for the 8-hour
Ozone National Ambient Air Quality Standards (1997 Ozone NAAQS)'' (73
FR 16205). EPA's proposed approval of this SIP submission addresses
Maryland's compliance with the portion of CAA section 110(a)(2)(C) &
(J) relating to the CAA's parts C and D permit programs for the 1997
Ozone NAAQS, because this proposed approval would approve regulating
NOX as a precursor to ozone in Maryland's SIP in accordance
with the Federal Register action dated November 29, 2005 (70 FR 71612)
that finalized NOX as a precursor for ozone regulations set
forth at 40 CFR 51.165 and in 40 CFR 52.21.

C. PM2.5

    On May 16, 2008, EPA promulgated the final ``Implementation of the
New Source Review (NSR) Program for Particulate Matter Less Than 2.5
Micrometers (PM2.5)'' (73 FR 28321). That action established
NSR applicability for PM2.5 precursor pollutants,
established major source thresholds and significant emissions rates for
PM2.5 and its precursors, and laid out a road map for states
to use in transitioning to addressing condensable particulate matter.
By incorporating by reference the federal regulations of 40 CFR 52.21
as codified in the July 1, 2009 edition of the Code of Federal
Regulations and submitting that change to EPA to be approved as a SIP
revision, Maryland has met its statutory obligations for PSD under the
May 16, 2008 PM2.5 rule.

D. Infrastructure

    Section 110(a) of the CAA requires states to submit SIPs that
provide for the implementation, maintenance, and enforcement of new or
revised NAAQS within three years following the promulgation of such
NAAQS. EPA is proposing to make a determination that the above
described submittals meet the portions of the CAA section 110(a)(2)(C),
(D)(i)(II) and (J) for the 1997 8-hour ozone and PM2.5 NAAQS
and the 2006 PM2.5 NAAQS which relate to Maryland's PSD
permit program. A summary of EPA's review of, and rationale for,
approving Maryland's submittals for purposes of meeting these statutory
requirements may be found in the Technical Support Document (TSD) for
this action. These proposed SIP Revisions, along with previously
approved SIP Revisions relating to Maryland's federally enforceable PSD
program, support a finding that Maryland has met its statutory
obligations pursuant to CAA section 110(a)(2) which relate to CAA title
I, part C requirements, including, but not limited to, relevant
portions of sections 110(a)(2)(C), (D)(i)(II) and (J).

E. Greenhouse Gases

    A detailed explanation of GHGs, climate change and the impact on
health, society, and the environment is included in EPA's technical
support documents (TSDs) for EPA's GHG endangerment finding final rule
(Document ID No. EPA-HQ-OAR-2009-0472-11292 at www.regulations.gov), as
well as the TSD for this current action.
    With regard to GHGs, the proposed action on the Maryland SIP
generally relates to four federal rulemaking actions. The first
rulemaking is EPA's Tailoring Rule. The second rulemaking is EPA's
``Action to Ensure Authority to Issue Permits Under the Prevention of
Significant Deterioration Program to Sources of Greenhouse Gas
Emissions: Finding of Substantial Inadequacy and SIP Call,'' (GHG SIP
Call) proposed on September 2, 2010 (75 FR 53892). The third rulemaking
is EPA's ``Action to Ensure Authority to Issue Permits Under the
Prevention of Significant Deterioration Program to Sources of
Greenhouse Gas Emissions: Federal Implementation Plan,'' (GHG FIP) also
proposed on September 2, 2010 (75 FR 53883), which serves as a
companion rulemaking to EPA's proposed GHG SIP Call. The fourth
rulemaking is the ``Limitation of Approval of Prevention of Significant
Deterioration Provisions Concerning Greenhouse Gas Emitting-Sources in
State Implementation Plans'' 75 FR 82536 (Narrowing Rule) (December 30,
2010). A summary of each of these rulemakings is described below.
    In the first rulemaking, the Tailoring Rule, EPA established
appropriate GHG emission thresholds for determining the applicability
of PSD requirements to GHG-emitting sources. In the second rulemaking,
the GHG SIP Call, EPA proposed to find that the EPA-approved PSD
programs in 13 States (not including Maryland) are substantially
inadequate to meet CAA requirements because they do not appear to apply
PSD requirements to GHG-emitting sources. For each of these States, EPA
proposed to require the State (through a ``SIP Call'') to revise its
SIP as necessary to correct such inadequacies. In the third rulemaking,
the GHG FIP, EPA proposed a FIP to apply in any state that is unable to
submit, by its deadline, a SIP revision to ensure that the state has
authority to issue PSD permits for GHG-emitting sources. Because
Maryland already has authority to regulate GHGs, Maryland is only
seeking to revise its SIP to put in place the GHG emission thresholds
for PSD applicability set forth in EPA's Tailoring Rule, thereby
ensuring that smaller GHG sources emitting less than these thresholds
are not subject to permitting requirements.
    In the Narrowing Rule, EPA limited its approval of those states'
programs which had the authority to regulate GHG's, but lacked a
vehicle to limit applicability to the higher thresholds established by
the Tailoring Rule. Maryland was one of the states impacted by the
Narrowing Rule. With the regulations submitted in the proposed SIP
revision, Maryland has adopted EPA's tailoring approach. These changes
to Maryland's regulations are also consistent with section 110 of the
CAA because they are incorporating GHGs for regulation in the Maryland
SIP.
    A complete overview of GHGs and GHG-emitting sources, the CAA PSD
program, minimum SIP elements for a PSD program, EPA's recent actions
regarding GHG permitting, as well as the relationship between the
proposed Maryland SIP revision and EPA's other national rulemakings,
and EPA's analysis of Maryland's SIP revision can be found in the
Technical Support Document (TSD) in the docket for this proposed rule
making action.

III. Proposed Action

    Pursuant to Section 110 of the Clean Air Act, EPA is proposing to
approve the Maryland SIP revisions as described above. EPA has made the
preliminary determination that these revisions are approvable because
they conform to the CAA and EPA regulations. EPA is soliciting public
comments on the issues discussed in this document. These comments will
be considered before taking final action.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed 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 CAA; 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 proposed rule regarding preconstruction
requirements under Maryland's PSD and non-attainment NSR programs 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, Carbon monoxide,
Greenhouse Gases, Incorporation by reference, Intergovernmental
relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting
and recordkeeping requirements, Sulfur oxides, Volatile organic
compounds.

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

    Dated: March 7, 2012.
W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2012-6561 Filed 3-16-12; 8:45 am]
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[Federal Register: December 12, 2007 (Volume 72, Number 238)]
[Notices]
[Page 70621-70622]
[DOCID:fr12de07-83]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56904; File No. SR-CTA-2007-02]

Consolidated Tape Association; Notice of Filing of the Eleventh
Substantive Amendment to the Second Restatement of the Consolidated
Tape Association Plan

December 5, 2007.
    Pursuant to Section 11A of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 608 thereunder,\2\ notice is hereby given that
on November 5, 2007, the Consolidated Tape Association (``CTA'') Plan
Participants (``Participants'')\3\ filed with the Securities and
Exchange Commission (``SEC'' or ``Commission'') a proposal to amend the
Second Restatement of the CTA Plan (the `` CTA Plan''). The proposal
represents the eleventh substantive amendment to the Plan (``Eleventh
Substantive Amendment'') and reflects changes unanimously adopted by
the Participants. The proposed amendment would permit Participants to
report to the Processor under the CTA Plan the actual number of shares
for each transaction (exclusive of odd-lots), rather than to report the
number of round lots for each transaction. The Commission is publishing
this notice to solicit comments from interested persons on the proposed
Eleventh Substantive Amendment to the CTA Plan.

I. Rule 608(a)

A. Description and Purpose of the Amendment

    The Plan currently requires Participants to include in their
transaction reports to the CTA Plan's processor the stock symbol of the
Eligible Security, the price at which the transaction was executed, and
the volume, in round lots, involved in the transaction.
    The Eleventh Substantive Amendment proposes to replace the
requirement that Participants report each transaction's volume in round
lots with a requirement that each Participant

report the actual number of shares for each transaction, exclusive of
odd-lots.
    The Participants believe that reporting transactions in the actual
number of shares traded rather than round lots will add greater
transparency to the marketplace. The Participants also believe that it
remains appropriate to exclude odd lots from CTA trade reporting
because the small size of odd-lot trades adds little to marketplace
transparency and because the number of odd-lot trades would merely
serve to clutter data feeds and make it more difficult for investors to
obtain a true view of the markets for Eligible Securities. The text of
the proposed Amendment is available on the CTA's Web site (http://www.nysedata.com/cta
), at the principal office of the CTA, and at the

Commission's Public Reference Room.

B. Additional Information Required by Rule 608(a)

1. Governing or Constituent Documents
    Not applicable.
2. Implementation of the Amendment
    The Participants propose to implement the change soon after receipt
of Commission approval of the Amendment, but no earlier than January 1,
2008.
3. Development and Implementation Phases
    See Item I(B)(2) above.
4. Analysis of Impact on Competition
    The amendment will impose no burden on competition.
5. Written Understanding or Agreements relating to Interpretation of,
or Participation in, Plan
    The Participants have no written understandings or agreements
relating to interpretation of the CTA Plan as a result of the
amendment.
6. Approval by Sponsors in Accordance With Plan
    Under Section IV(b) of the CTA Plan, each Plan Participant must
execute a written amendment to the CTA Plan before the amendment can
become effective. The amendment is so executed.
7. Description of Operation of Facility Contemplated by the Proposed
Amendment
    a. Terms and Conditions of Access
    Not applicable.
    b. Method of Determination and Imposition, and Amount of, Fees and
Charges
    Not applicable.
    c. Method of Frequency of Processor Evaluation
    Not applicable.
    d. Dispute Resolution
    Not applicable.

II. Rule 601(a)

A. Equity Securities for Which Transaction Reports Shall Be Required by
the Plan

    Not applicable.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78k-1.
    \2\ 17 CFR 242.608.
    \3\ Each Participant executed the proposed amendment. The
Participants are the American Stock Exchange LLC; Boston Stock
Exchange, Inc.; Chicago Board Options Exchange, Inc.; Chicago Stock
Exchange, Inc.; International Securities Exchange, LLC; The NASDAQ
Stock Market LLC; National Association of Securities Dealers, Inc.
(n/k/a the Financial Industry Regulatory Authority); National Stock
Exchange, Inc.; New York Stock Exchange LLC.; NYSE Arca, Inc.; and
Philadelphia Stock Exchange, Inc.
---------------------------------------------------------------------------

B. Reporting Requirements

    Not applicable.

C. Manner of Collecting, Processing, Sequencing, Making Available and
Disseminating Last Sale Information

    Not applicable.

D. Manner of Consolidation

    Not applicable.

E. Standards and Methods Ensuring Promptness, Accuracy and Completeness
of Transaction Reports

    Not applicable.

F. Rules and Procedures Addressed to Fraudulent or Manipulative
Dissemination

    Not applicable.

G. Terms of Access to Transaction Reports

    Not applicable.

H. Identification of Marketplace Execution

    Not applicable.

III. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed
Eleventh Substantive Amendment 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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CTA-2007-02 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CTA-2007-02. This file
number should be included on the subject line if e-mail 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 Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the Plan amendment that are filed
with the Commission, and all written communications relating to the
Plan amendment 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 inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the CTA Plan amendment also will be available
for inspection and copying at the principal office of the CTA. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CTA-2007-02 and should be
submitted on or before January 2, 2008.

For the Commission, by the Division of Trading and Markets, pursuant
to delegated authority.\4\
---------------------------------------------------------------------------

    \4\ 17 CFR 200.30-3(a)(27).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-23966 Filed 12-11-07; 8:45 am]

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[Federal Register Volume 81, Number 58 (Friday, March 25, 2016)]
[Notices]
[Pages 16245-16247]
[FR Doc No: 2016-06747]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77413; File No. SR-ICC-2016-003]

Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of
Filing of Proposed Rule Change To Revise the ICC Operational Risk
Management Framework

March 21, 2016.
    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 March 10, 2016, ICE Clear Credit LLC (``ICC'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I, II, and III below, which Items have
been prepared primarily by ICC. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

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

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

    The principal purpose of the proposed rule change is to update
ICC's Operational Risk Management Framework. These revisions do not
require any changes to the ICC Clearing Rules.

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

    In its filing with the Commission, ICC 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. ICC has prepared summaries, set forth in sections A, B,
and C below, of the most significant aspects of these statements.

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

    ICC proposes updates to the ICC Operational Risk Management
Framework. ICC believes such revisions will facilitate the prompt and
accurate clearance and settlement of securities transactions and
derivative agreements, contracts, and transactions for which it is
responsible. The proposed revisions are described in detail as follows.
    The ICC Operational Risk Management Framework details ICC's dynamic
and independent program of risk assessment and oversight, managed by
the Operational Risk Manager (``ORM''), which aims to reduce
operational incidents, encourage process and control improvement, bring
transparency to operational performance standard monitoring, and
fulfill regulatory obligations. ICC proposes organizational changes to
its Operational Risk Management Framework related to its operational
risk management processes.
    ICC has revised the Operational Risk Management Framework to frame
its existing operational risk program and processes around an
operational risk lifecycle, designed to highlight certain aspects of
the processes and present the processes in a more efficient manner. The
operational risk lifecycle utilized by ICC has five components:
Identify, assess, monitor, mitigate and report. Each of these lifecycle
components are first defined generally in the document then applied to
each of ICC's two operational risk processes: Risk assessment; and
performance objectives setting and monitoring. Specifically, the
content for each risk process has been reorganized to fall into each of
the operational risk lifecycle components (i.e., identify, assess,
monitor, mitigate, and report). For completion purposes,

ICC added information regarding the `assess' and `report' component of
the risk assessment process. Specifically, ICC assesses each of its
risk scenarios to determine the inherent risk rating associated with
the occurrence of an event or incident, as well as assess the
effectiveness of any relevant risk controls. Further, in the `report'
component, ICC clarified that the ORM presents operational risk
reporting to an internal committee which includes members of senior
management. The responsibilities of the ORM, which were previously
listed out in the document, were incorporated into the risk lifecycles.
The ORM will continue to provide management and staff with advice and
guidance related to the development of controls designed to increase
performance and reduce processing risk, as part of the `mitigate' risk
lifecycle component. Similarly, the responsibilities of senior
management, which were previously listed out in the document, were
incorporated into the risk lifecycles.
    ICC has categorized those aspects of the operational risk
management program which do not fall within this lifecycle as
``Operational Risk Focus Areas.'' These risk focus areas include:
Business continuity planning and disaster recovery; vendor assessment;
new products and initiatives; information security; and technology
control functions. ICC has reorganized the order of these risk focus
areas to better distinguish which functions may, with oversight by the
ORM, be outsourced to Intercontinental Exchange, Inc. (``ICE, Inc.'')
or performed by departments dedicated to that particular risk area.
    ICC has made several clarifying and organizational enhancements to
the various risk focus area descriptions. Further, specific details
contained within other ICC policies and procedures were removed and
described more generally within the Operational Risk Management
Framework, in an effort to reduce redundancy amongst ICC policies and
procedures. ICC continues to maintain business continuity planning and
disaster recovery as two separate programs with separate and distinct
components; however, ICC has grouped the description of these programs
together for purposes of the Operational Risk Management Framework. ICC
enhanced the ``Vendor Assessment'' risk focus area description to note
that the ORM is responsible for conducting a service provider risk
assessment for critical vendors, and to list the specific steps taken
as part of such risk assessment. ICC also enhanced the ``Information
Security'' risk focus area description to note that the ICE, Inc.
Information Security Department conducts its own risk assessments
related to information security and physical security/environmental
controls, pursuant to internal policies which are maintained by an ICE,
Inc. internal committee. Information regarding the Firm Wide Incident
Management Program was included in the new `Technology Controls
Section.' ICC enhanced the `Technology Control Functions' risk focus
area description to note that the ICC Systems Operations team is
responsible for executing daily clearing functions within established
service expectations and performing incident management. ICC described
this incident management process generally within the framework, and
removed more detailed aspects of the program which are contained in
specific program documentation.
    General information regarding the development and enforcement of a
firm-wide operational risk framework was removed, as the revised
framework more clearly lays out in each particular section who is
responsible for the development and enforcement of that component of
the operational risk management framework. Information regarding the
human resource reporting line of the ORM and specific references to
titles of documents utilized as part of the risk assessment process
were removed. As the Vendor Risk Management policy was retired and
encompassed within the Operational Risk Management Framework, reference
to the policy was removed from the document. ICC removed internal audit
responsibilities from the Operational Risk Management Framework as such
responsibilities are contained within internal audit documentation.
    The overall governance of the Operational Risk Framework has been
updated to reflect current practices. Specifically, material amendments
are reviewed by the Risk Committee, and approved by the Board. The
Board reviews the Operational Risk Management Framework at least
annually.
    Other non-material changes were made to the framework to enhance
readability. Previously, ICC included regulatory requirements and
industry guidance information within the framework; this information
has been moved to a separate appendix to the framework. Further,
information regarding Regulation Systems, Compliance, and Integrity has
been added for completeness. Certain information regarding governance
and governing committees has been resituated to the reporting section
of the relevant operational risk lifecycle. Similarly, information
regarding the roles and responsibilities of the ORM and senior
management has been resituated to the appropriate section the
operational risk lifecycle.
    Section 17A(b)(3)(F) of the Act \3\ requires, among other things,
that the rules of a clearing agency be designed to protect investors
and the public interest and to comply with the provisions of the Act
and the rules and regulations thereunder. ICC believes that the
proposed rule changes are consistent with the requirements of the Act
and the rules and regulations thereunder applicable to ICC, in
particular, to Section 17(A)(b)(3)(F),\4\ because ICC believes that the
proposed rule changes will protect investors and the public interest,
as the reorganization of ICC's existing operational risk processes
around the operational risk lifecycle promotes readability and
efficiency, and alleviates potential confusion throughout the
Operational Risk Management Framework. In addition, the proposed
revisions are consistent with the relevant requirements of Rule 17Ad-
22.\5\ The changes to the ICC Operational Risk Management Framework
further ensure that ICC, through its operational risk program, is able
to identify sources of operational risk and minimize them through the
development of appropriate systems, control, and procedures. Thus, the
changes are reasonably designed to meet the operational risk
requirements of Rule 17Ad-22(d)(4).\6\ As such, the proposed changes
are designed to promote the prompt and accurate clearance and
settlement of securities transactions, derivatives agreements,
contracts, and transactions within the meaning of Section 17A(b)(3)(F)
\7\ of the Act.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78q-1(b)(3)(F).
    \4\ Id.
    \5\ 17 CFR 240.17Ad-22.
    \6\ 17 CFR 240.17Ad-22(d)(4).
    \7\ Id.
---------------------------------------------------------------------------

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

    ICC does not believe the proposed rule changes would have any
impact, or impose any burden, on competition. The ICC Operational Risk
Management Framework applies uniformly across all market participants.
Therefore, ICC does not believe the proposed rule changes impose any
burden on competition that is inappropriate in furtherance of the
purposes of the Act.

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

    Written comments relating to the proposed rule change have not been
solicited or received. ICC will notify the Commission of any written
comments received by ICC.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ICC-2016-003 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-ICC-2016-003. 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 Web site (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 Web site 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 such filings will also be available
for inspection and copying at the principal office of ICE Clear Credit
and on ICE Clear Credit's Web site at https://www.theice.com/clear-credit/regulation.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-ICC-2016-003
and should be submitted on or before April 15, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Brent J. Fields,
Secretary.
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. 2016-06747 Filed 3-24-16; 8:45 am]
 BILLING CODE 8011-01-P


Comment Info: =================

General Comment: Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I am very passionate about e-cigarettes as an alternative to the traditional combustible cigarettes. Quite simply, I firmly believe that they saved my life.  Once I ventured in to the world of vaping, I never looked back.  I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

This morning I saw you on my local fox news speaking about the proposed regulation.  I did take note on how you commented on most people that use "e-cigarettes" still use combustible cigarettes.  This could be true but I believe there are a lot of poor products on the market which very well can cause consumers to not completely remove tobacco cigarettes from their lives.  The classic cigarette style just does not do justice in my eyes.  I am worried that some of these regulations will remove great products and companies from the market.  Almost all of the devices are made basically the same.  They use different metals for conductivity.  Why should one submit a product to be reviewed by the FDA when the last device was technically the same?  I don't see the reason and logic.  This will be very costly for these small companies.  If many of these businesses can't afford to do this they will fold or sell to larger or even big tobacco companies and i believe that they will do with out these types of products and continue producing poor devices which can cause consumers to give up and many could go back to smoking cigarettes again.  I thought we would like people to get off tobacco cigarettes if they would like to.  This is supposed to be a free country and vaping is something I choose to do.  Is there a risk?  Sure, everything comes with a risk.  I feel there is no possible way e-cigarettes will harm someone as much as cigarettes will.  On the fox news interview I saw today, you stated the FDA whats to protect us, the consumers.  Again, this is a choice I made like many others.  I agree warning labels need to be added to products and sales to minors should have NEVER happened in the first place.  I want to see those rules put in place.   My wife had smoked cigarettes for about 20 years.  Over a year ago I purchased a couple cig-a-like e-cigarettes from the gas station for her.  She did not like it at all so she kept smoking cigarettes.  For that style of product they are probably just not good between battery life and taste.  I myself did not like the product.  Months later I purchased her an "Ego" styled device which has a tank for re-filling the liquid and since then she hasn't looked back.  This is huge.  I never thought she would finally kick the habit and I am extremely happy for her.  She feels great, I feel great, to me the products we use has changed our lives in a great way.  We have both been lowering the nicotine levels in our e-liquid.  I am very low now and am close to be using 0mg nicotine e-liquid.  When this happens how am I using a tobacco product?  Also, not all nicotine is derived from tobacco plants.  When not, how is it labeled a tobacco product?  The government claims they want build small buisness so please lets keep doing this.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11762-11763]
[FR Doc No: 2022-04385]

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

SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34517]

Application: Deregistration Under the Investment Company Act

AGENCY: Securities and Exchange Commission (``Commission'' or ``SEC'').

ACTION: Notice of Applications for Deregistration under Section 8(f) of
the Investment Company Act of 1940.

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

    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
February 2022. A copy of each application may be obtained via the
Commission's website by searching for the applicable file number listed
below, or for an applicant using the Company name search field, on the
SEC's EDGAR system. The SEC's EDGAR system may be searched at https://www.sec.gov/edgar/searchedgar/legacy/companysearch.html. You may also
call the SEC's Public Reference Room at<PHONE_NUMBER>. An order
granting each application will be issued unless the SEC orders a
hearing. Interested persons may request a hearing on any application by
emailing the SEC's Secretary at [email protected] and serving
the relevant applicant with a copy of the request by email, if an email
address is listed for the relevant applicant below, or personally or by
mail, if a physical address is listed for the relevant applicant below.
Hearing requests should be received by the SEC by 5:30 p.m. on March
22, 2022, and should be accompanied by proof of service on applicants,
in the form of an affidavit or, for lawyers, a certificate of service.
Pursuant to Rule 0-5 under the Act, hearing requests should state the
nature of the writer's interest, any facts bearing upon the
desirability of a hearing on the matter, the reason for the request,
and the issues contested. Persons who wish to be notified of a hearing
may request notification by writing to the Commission's Secretary at
[email protected].

ADDRESSES: The Commission: [email protected].

FOR FURTHER INFORMATION CONTACT: Shawn Davis, Assistant Director, at
(202) 551-6413 or Chief Counsel's Office at<PHONE_NUMBER>; SEC,
Division of Investment Management, Chief Counsel's Office, 100 F Street
NE, Washington, DC 20549-8010.

Blackstone Real Estate Income Fund [File No. 811-22900]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On January
22, 2021, April 26, 2021, August 23, 2021, and November 29, 2021,
applicant made liquidating distributions to its shareholders based on
net asset value. Expenses of $2,636.80 incurred in connection with the
liquidation were paid by the applicant.
    Filing Dates: The application was filed on December 16, 2021, and
amended on February 22, 2022.
    Applicant's Address: [email protected].

Blackstone Real Estate Income Fund II [File No. 811-22907]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On January
22, 2021, April 26, 2021, August 23, 2021, and November 29, 2021,
applicant made liquidating distributions to its shareholders based on
net asset value. Expenses of $3,336.80 incurred in connection with the
liquidation were paid by the applicant.
    Filing Dates: The application was filed on December 16, 2021, and
amended on February 22, 2022.
    Applicant's Address: [email protected].

Blackstone Real Estate Income Master Fund [File No. 811-22908]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On January
22, 2021, April 26, 2021, August 23, 2021, and November 29, 2021,
applicant made liquidating distributions to its shareholders based on
net asset value. Expenses of $753,832.95 incurred in connection with
the liquidation were paid by the applicant.
    Filing Dates: The application was filed on December 16, 2021, and
amended on February 22, 2022.
    Applicant's Address: [email protected].

Duff & Phelps Select MLP & Midstream Energy Fund Inc. [File No. 811-
22958]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. The applicant
has transferred its assets to Virtus Duff & Phelps Select MLP and
Energy Fund, a series of Virtus Alternative Solutions Trust and on June
25, 2021 made a final distribution to its shareholders based on net
asset value. Expenses of $250,000 incurred in connection with the
reorganization were paid by the applicant.
    Filing Date: The application was filed on January 25, 2022.
    Applicant's Address: [email protected].

Putnam Mortgage Recovery Fund [File No. 811-22654]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On December
16, 2021, applicant made liquidating distributions to its shareholders
based on net asset value. Expenses of $9,000 incurred in connection
with the liquidation were paid by the applicant's investment adviser.
    Filing Date: The application was filed on January 27, 2022.
    Applicant's Address: [email protected].

Schroder Series Trust [File No. 811-07840]

    Summary: Applicant seeks an order declaring that it has ceased to
be an

investment company. The applicant has transferred its assets to
Hartford Schroders Sustainable Core Bond Fund, a series of The Hartford
Mutual Funds II, Inc., and on November 12, 2021 made a final
distribution to its shareholders based on net asset value. Expenses of
approximately $381,043.32 incurred in connection with the
reorganization were paid by the applicant, the applicant's investment
adviser and the acquiring fund's investment adviser.
    Filing Date: The application was filed on February 2, 2022.
    Applicant's Address: [email protected].

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.

    Dated: February 25, 2022.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2022-04385 Filed 3-1-22; 8:45 am]
BILLING CODE 8011-01-P


  SEQ CHAPTER \h \r 1 ICF Consulting Review of Yamada et al. (2003)

ICF has been asked to review the journal article, “Exposure to
1-bromopropane (i.e., n-propylbromide) causes ovarian dysfunction in
rats” by Yamada and coworkers (2003).  Details regarding the study
design, results, and major conclusions are detailed in the following
text.  Further, ICF will discuss the relevance of this study to other
studies in rodents and will discuss whether this study allows for the
identification of an alternate NOAEL/LOAEL for the determination of an
Acceptable Exposure Limit for n-propylbromide.

Study Design

Female Wistar rats at 10 weeks of age (and presumably nulliparous), were
exposed to target concentrations of 0 (fresh air), 200, 400, or 800 ppm
n-propylbromide (10/group) in whole-body inhalation chambers for 8
hours/day, 7 days/week for 12 weeks. For three weeks prior to exposure,
the estrous cycles of the rats were monitored.  Measured concentrations
of nPB in the dose groups were the following:  0, 200±8, 415±19, and
813±28 ppm (mean ± SD).  After 7 weeks of exposure, all the rats at
800 ppm became seriously ill and were sacrificed.  Rats from the
remaining dose groups were decapitated on the day of diestrus I in the
13th week.

The estrus cycle was monitored during the study period via the analysis
of vaginal smears taken at the same time each day.  The estrus cycle was
divided into four periods: proestrus, estrus, diestrus I, and diestrus
II.  Normal estrus cycles were those containing each defined period,
which typically lasted 4-6 days.  The 15-week study period was divided
into the three week pre-exposure period, and 4 exposure periods of 3
weeks in length.  If a cycle overlapped two consecutive study periods,
then 0.5 cycle was counted in each period.  Cycles were defined as
regular (3-5 cycles/period), irregular (0.5-2.5 cycles/period), or
absent (no cycle; 0 cycles/period).

μm serial sections).  Differential follicle counts were determined as
primordial (types 1-3b), growing, (types 4-5b), and antral (types 6-8).
The follicles were differentiated by the following pathologic
characteristics: primordial, oocytes either with or without a complete
one-layer ring of granulosa cells; growing, oocytes with several layers
of surrounding granulosa cells without antrum (cavity within the
follicle) formation; antral, large oocytes with multiple layers of
surrounding granulosa cells and fluid-filled antrum.

Study Results

Body weights were significantly decreased in all females at 800 ppm
starting at week 2 and continuing to week 7 (the rats lost 17% of their
pre-exposure body weight, rather than gaining weight during the exposure
period); the animals were sacrificed during week 8 because of
moribundity.  The body weights of the other exposure groups did not
differ significantly from the controls during any exposure week.  Forty
percent of the high-dose rats (4/10) had irregular estrous cycles during
weeks 1-3 of exposure, with the remaining females (6/10) having regular
cycles.  This trend toward cycle irregularity continued in the high-dose
females, with 50% having irregular cycles at 4-6 weeks of exposure and
50% having no cycle during this period.  After 1-3 weeks exposure, 1/10
females at 200 ppm nPB had an irregular cycle, with 9/10 at this
concentration having a regular cycle.  All of the females at 400 ppm had
regular cycles after 1-3 weeks exposure.  At every subsequent exposure
period, the females at 200 ppm exhibited regular cycles.  After 4-6
weeks exposure to nPB, one female at 400 ppm which had no cycle, while
the remaining 9/10 had regular cycles.  At 7-9 weeks, 3/10 females at
400 ppm had irregular cycles, 7/10 had regular cycles.  At 10-12 weeks
exposure, 4/10 had regular cycles, 5/10 had irregular cycles, and 1/10
had no cycle.  The data are presented in Table 1 below.

Table 1.  Changes in Estrus Cycle in Female Rats Exposed to
n-Propylbromide

Dose

(ppm)	Before Exp.	1-3 Weeks	4-6 Weeks	7-9 Weeks	10-12 Weeks

	Reg	Irreg	None	Reg	Irreg	None	Reg	Irreg	None	Reg	Irreg	None	Reg	Irreg
None

0a	9	0	0	9	0	0	9	0	0	9	0	0	9	0	0

200	10	0	0	9	1	0	10	0	0	10	0	0	10	0	0

400	10	0	0	10	0	0	9	0	1	7	3	0**	4	5	1**

800	10	0	0	6	4	0*	0	5	5**

Numbers per dose group were as follows: Control, 9; 200 ppm, 10; 400
ppm, 10; 800 ppm, 10.

*p<0.05; **p<0.01

Reproductive organ weights in the 200- and 400-ppm groups did not differ
from the controls.  Because the 800-ppm rats were sacrificed early,
their body and organ weights were not included in the statistical
analysis.  Absolute and relative liver and kidney weights were increased
in the 200- and 400-ppm females compared to the controls.  No abnormal
histopathological findings in these organs were reported in these dose
groups, however.  In the 800-ppm females, mild dilatation of the
proximal tubules was noted in the kidneys as well as scattered
cytoplasmic degeneration in hepatocytes located around the central veins
in the liver, which was accompanied by nuclear pyknosis.  No serious
changes (e.g., diffuse or focal necrosis) were reported.

Changes in the number of the different types of ovarian follicles were
noted among the exposure groups (data in Table 2 below).  The 200-ppm
group did not exhibit any significant histopathology in the ovaries, but
the number of antral follicales was significantly decreased (59%)
compared to controls.  The number of growing and primordial follicles
was not significantly different at this dose.  The number of growing and
primordial follicles at 400 ppm was significantly decreased compared to
controls (76% and 33%, respectively).  The numbers of developed
follicles was further decreased in the high-dose females sacrificed
after 7 weeks, but it is unclear whether this is because of the younger
developmental age of the rats or because of the exposure, or both.  No
changes in LH or FSH were noted in the 200- and 400-ppm dose groups.

Table 2.  Changes in Ovarian Follicle Development in nPB-Exposed Female
Rats

	Control (n=8)	200 ppm (n=9)	400 ppm (n=9)	800 ppm (n=9)

Exposure Duration	12 weeks	12 weeks	12 weeks	7 weeks

Primordial	176.8±48.8	157.8±49.4	206.0±66.6	423.1±140

Growing	70.0±20.3	53.4±17.9	47.2±17.3*	30.1±15.1

Antral	30.1±22.4	12.6±4.82*	7.44±6.52**	3.78±3.87

These data suggest that nPB is affecting the maturation of ovarian
follicles; the mechanism is unclear, based on the data.  Although there
was a significant decrease in antral follicles at 200 ppm, there were no
changes in estrus cycling at this exposure concentration.  A decrease in
the number of female rats exhibiting regular estrus cycles was observed
in 400-ppm females during 7-9 weeks of exposure and later.  Therefore, a
NOAEL of 200 ppm is identified with a LOAEL of 400 ppm for the changes
in estrus cycles.  The data from this study can be used to determine an
alternate benchmark dose for female reproductive effects.  Without
performing the benchmark dose analysis, it is not clear whether these
data provide a more sensitive endpoint of nPB-induced reproductive
toxicity than sperm motility in exposed males.

References

Yamada T, Ichihara G, Wang H, et al. 2003.  Exposure to 1-bromopropane
causes ovarian dysfunction in rats.  Toxicol Sci 71:96-103.