[Federal Register: October 12, 2006 (Volume 71, Number 197)]
[Notices]
[Page 60143-60144]
[DOCID:fr12oc06-45]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8230-7; Docket ID No. EPA-HQ-ORD-2006-0756]

Evaluation of the Carcinogenicity of Ethylene Oxide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Extension of Public Comment Period.

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SUMMARY: EPA is announcing an extension of the public comment period
for the draft document titled, ``Evaluation of the Carcinogenicity of
Ethylene Oxide'' (EPA/635/R-06/003). The document was prepared by the
National Center for Environmental Assessment within EPA's Office of
Research and Development. On September 22, EPA published a Federal
Register notice (71 FR 55470) announcing a 30-day comment period that
ends October 23, 2007. EPA is extending the public comment period to
December 8, 2006, in response to requests.
    As previously stated in 71 FR 55470, EPA is releasing this draft
document solely for the purpose of seeking public comment and for
review by the EPA Science Advisory Board (SAB) via a meeting to be held
at a later date (time and place to be specified in a separate Federal
Register notice). This document has not been formally disseminated by
EPA. It does not determination. EPA will consider any public comments
submitted in accordance with this notice when revising the document.

DATES: The public comment period began September 22, 2006, and ends
December 8, 2006. Technical comments should be in writing and must be
received by EPA by December 8, 2006.

ADDRESSES: The draft ``Evaluation of the Carcinogenicity of Ethylene
Oxide'' is available primarily via the Internet on the National Center
for Environmental Assessment's home page under the Recent Additions and
the Data and Publications menus at http://www.epa.gov/ncea. A limited

number of paper copies are available from the Technical Information
Staff, NCEA-W; telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>. If you
are requesting a paper copy, please provide your name, your mailing
address, and the document title, ``Evaluation of the Carcinogenicity of
Ethylene Oxide''.
    Comments may be submitted electronically via http://www.regulations.gov,

by mail, by facsimile, or by hand delivery/courier. Please follow the
detailed instructions provided in the SUPPLEMENTARY INFORMATION section
of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>
    For technical information, contact Henry D. Kahn, D.Sc., NCEA;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Information About the Project/Document

    Ethylene oxide (EtO) is a gas at room temperature. It is
manufactured from ethylene and used primarily as a chemical
intermediate in the manufacture of ethylene glycol. It is also used as
a sterilizing agent for medical equipment and as a fumigating agent for
spices. The largest sources of human exposure are in occupations
involving contact with the gas in production facilities and in
hospitals that sterilize medical equipment. EtO can also be inhaled by
residents living near production or sterilizing/fumigating facilities.
    This draft assessment document characterizes the potential for a
carcinogenic health hazard from human inhalation exposure to EtO. This
is accomplished by a weight-of-evidence evaluation as to how likely EtO
is to be a human carcinogen, as well as an evaluation of related dose-
response information which leads to the development of lifetime cancer
risk estimates per unit of exposure. This assessment, when finalized,
will be posted to EPA's Integrated Risk Information System (IRIS)
database. The document was prepared by EPA's National Center for
Environmental Assessment (NCEA). EPA last published a health assessment
of the potential carcinogenicity of EtO in 1985.
    The current assessment reviews the more recently developed database
on the carcinogenicity of EtO, pertinent data from the 1985 assessment,
and several reviews and assessments issued

by other organizations (IARC, 1994; Health Canada, 2001; CalEPA, 1999;
EOIC, 2001).

II. How to Submit Technical Comments to the Docket at
http://www.regulations.gov

    Note: The EPA Docket Center suffered damage due to flooding
during the last week of June 2006. The Docket Center is continuing
to operate. However, during the cleanup, there will be temporary
changes to Docket Center telephone numbers, addresses, and hours of
operation for people who wish to make hand deliveries or visit the
Public Reading Room to view documents. Consult EPA's Federal
Register notice at 71 FR 38147 (July 5, 2006) or the EPA Web site at
http://www.epa.gov/epahome/dockets.htm for current information on

docket operations, locations and telephone numbers. The Docket
Center's mailing address for U.S. mail and the procedure for
submitting comments to http://www.regulations.gov are not affected by the

flooding and will remain the same.

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD 2006-
0756 by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, 1301 Constitution Ave.,
NW., Washington, DC. The EPA Docket Center Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is 202-566-
1744. Such deliveries are only accepted during the docket's normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.
    If you submit comments by mail or hand delivery, please submit one
unbound original with pages numbered consecutively, and three copies of
the comments. For attachments, provide an index, number pages
consecutively with the comments, and submit an unbound original and
three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2006-0756. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at
http://www.regulations.gov, including any personal information provided,

unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov,

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: Documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the EPA

Headquarters Docket Center.

    Dated: October 4, 2006.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. E6-16921 Filed 10-11-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)]
[Notices]
[Pages 58797-58799]
[FR Doc No: 2015-24716]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75979; File No. SR-NYSEArca-2015-80]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Relating to a
Change to the Secondary Benchmark Index Applicable to Shares of the
PIMCO Global Advantage[supreg] Inflation-Linked Bond Active Exchange-
Traded Fund

September 24, 2015.
    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, 2015, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') 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 Substance
of the Proposed Rule Change

    The Exchange proposes to reflect a change to the secondary
benchmark index applicable to shares of the PIMCO Global
Advantage[supreg] Inflation-Linked Bond Active Exchange-Traded Fund.
The Fund is currently listed and traded on the Exchange under NYSE Arca
Equities Rule 8.600. The text of 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Commission has approved a proposed rule change relating to
listing and trading on the Exchange of shares (``Shares'') of the PIMCO
Global Advantage[supreg] Inflation-Linked Bond Active Exchange-Traded
Fund (``Fund'') under NYSE Arca Equities Rule 8.600,\4\ which governs
the listing and trading of Managed Fund Shares.\5\ The Shares are

offered by PIMCO ETF Trust (the ``Trust''), a statutory trust organized
under the laws of the State of Delaware and registered with the
Commission as an open-end management investment company.\6\ The
investment manager to the Fund is Pacific Investment Management Company
LLC (``PIMCO'' or the ``Adviser''). The Fund's Shares are currently
listed and traded on the Exchange under NYSE Arca Equities Rule 8.600.
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    \4\ See Securities Exchange Act Release No. 66381 (February 10,
2012), 77 FR 9281 (February 16, 2012) (SR-NYSEArca-2012-09) (notice
of filing of proposed rule change relating to listing and trading of
Shares of the Fund on the Exchange) (``Prior Notice''); Securities
Exchange Act Release No. 66670 (March 28, 2012), 77 FR 20087 (April
3, 2012) (SR-NYSEArca-2012-09) (order approving listing and trading
of Shares of the Fund on the Exchange) (``Prior Order'' and,
together with the Prior Notice, the ``Prior Release'').
    \5\ A Managed Fund Share is a security that represents an
interest in an investment company registered under the Investment
Company Act of 1940 (15 U.S.C. 80a-1) (``1940 Act'') organized as an
open-end investment company or similar entity that invests in a
portfolio of securities selected by its investment adviser
consistent with its investment objectives and policies. In contrast,
an open-end investment company that issues Investment Company Units,
listed and traded on the Exchange under NYSE Arca Equities Rule
5.2(j)(3), seeks to provide investment results that correspond
generally to the price and yield performance of a specific foreign
or domestic stock index, fixed income securities index or
combination thereof.
    \6\ The Trust is registered under the Investment Company Act of
1940 (``1940 Act''). On October 27, 2014, the Trust filed with the
Commission the most recent post-effective amendment to its
registration statement under the Securities Act of 1933 (15 U.S.C.
77a) (``1933 Act'') and under the 1940 Act relating to the Fund
(File Nos. 333-155395 and 811-22250) (the ``Registration
Statement''). The description of the operation of the Trust and the
Fund herein is based, in part, on the Registration Statement. A
change to the name of the Fund from PIMCO Global Advantage[supreg]
Inflation-Linked Bond Exchange-Traded Fund to PIMCO Global
Advantage[supreg] Inflation-Linked Bond Active Exchange-Traded Fund
was reflected in such amendment to the Registration Statement. In
addition, the Commission has issued an order granting certain
exemptive relief to the Trust under the 1940 Act. See Investment
Company Act Release No. 28993 (November 10, 2009) (File No. 812-
13571) (``Exemptive Order'').
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    According to the Registration Statement and the Prior Release, the
Fund utilizes the PIMCO Global Advantage Inflation-Linked Bond
Index[supreg] as a secondary benchmark. Going forward, the Fund
proposes to utilize the PIMCO Global Advantage Inflation-Linked Bond
Index[supreg] (USD Partially Hedged) as the Fund's secondary benchmark.
The proposal would change the secondary benchmark used by the Fund from
an unhedged version of the index to one that is partially-hedged.
    The Adviser represents that the proposed change to the secondary
benchmark index is consistent with the Fund's investment objective, and
will further assist the Adviser to achieve such investment objective.
The Adviser further represents that the change to the secondary
benchmark index may better optimize the risk/return profile of the Fund
as compared to the prior secondary benchmark index. Except for the
change noted above, all other representations made in the Prior Release
remain unchanged.\7\ The Fund will continue to comply with all initial
and continued listing requirements under NYSE Arca Equities Rule 8.600.
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    \7\ See note 4, supra. All terms referenced but not defined
herein are defined in the Prior Release.
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    Although the investment objective of the Fund is not changing, it
will be indirectly affected by the proposed change because the Fund's
investment objective is to seek ``total return which exceeds that of
its benchmark indexes, consistent with prudent investment management.''
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) \8\ that an exchange have rules that
are designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to remove
impediments to, and perfect the mechanism of a free and open market
and, in general, to protect investors and the public interest.
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    \8\ 15 U.S.C. 78f(b)(5).
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    The proposed rule change is designed to perfect the mechanism of a
free and open market and, in general, to protect investors and the
public interest. The proposed change to the Fund's secondary benchmark
index will not adversely impact investors or Exchange trading. The
proposal would change the secondary benchmark used by the Fund from an
unhedged version of the index to one that is partially-hedged. The
Adviser represents that the proposed change to the secondary benchmark
index is consistent with the Fund's investment objective and will
further assist the Adviser to achieve such investment objective. The
Adviser further represents that the change to the secondary benchmark
index may better optimize the risk/return profile of the Fund as
compared to the prior secondary benchmark index. Except for the change
noted above, all other representations made in the Prior Release remain
unchanged.

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 purpose of the Act. The Exchange believes the
proposed rule change will enhance competition among issues of exchange-
traded funds that invest in fixed income securities.

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, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(6) thereunder.\10\
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 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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    At any time within 60 days of the filing of such 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 under
Section 19(b)(2)(B) of the Act \11\ to determine whether the proposed
rule change should be approved or disapproved.
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    \11\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-NYSEArca-2015-80 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-NYSEArca-2015-80. 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 Section, 100 F Street NE.,
Washington, DC 20549 on official business days between 10 a.m. and 3
p.m. Copies of the filing will also be available for inspection and
copying at the NYSE's principal office and on its Internet Web site at
www.nyse.com. 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-
NYSEArca-2015-80 and should be submitted on or before October 21, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-24716 Filed 9-29-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Notices]
[Page 3610-3611]
[DOCID:fr21ja09-85]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0007]

Draft Guidance for Industry on Animal Models--Essential Elements
to Address Efficacy Under the Animal Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: FDA is announcing the availability of a draft guidance
entitled ``Animal Models--Essential Elements to Address Efficacy Under
the Animal Rule.'' When human efficacy studies are neither ethical nor
feasible, animal efficacy studies may be relied on under the Animal
Rule to support approval or licensure of a drug or biological product.
This guidance identifies and discusses the critical characteristics of
an animal model that should be addressed when developing products for
approval under the Animal Rule. The guidance is intended to help
sponsors determine whether the model meets the requirements of the
Animal Rule.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by March 23, 2009.

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

FOR FURTHER INFORMATION CONTACT:
    Rosemary Roberts, Office of Counter-Terrorism and Emergency
Coordination, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3342, Mail Stop
3329, Silver Spring, MD 20993,<PHONE_NUMBER> or
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-
827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Animal Models--Essential Elements to Address Efficacy Under
the Animal Rule.'' The purpose of this draft guidance is to assist
sponsors to identify the critical characteristics of an animal model
that should be addressed when efficacy of an investigational product
will be established under the ``Animal Rule'' (see 21 CFR 314.600; 21
CFR 601.90). Critical characteristics include, but are not limited to,
information regarding the natural history of the condition to be
treated in humans and animals, the challenge agent, route of exposure
to the challenge agent, and the timing of intervention with the study
drug. Data from human experience with the etiologic agent or with the
intervention, when available, may support applicability of the animal
model. The information described in the draft guidance is relevant for
any animal model being considered as a basis for establishing efficacy
under the Animal Rule and is intended to help determine whether the
model meets the requirements of the Animal Rule.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on animal
models when addressing efficacy under the animal rule. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that

individuals may submit one paper copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder.guidance/index.htm, http://www.fda.gov/
cber/guidelines.htm or http://www.regulations.gov.

    Dated: January 12, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-936 Filed 1-16-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 96 (Thursday, May 18, 2023)]
[Rules and Regulations]
[Pages 31625-31629]
[FR Doc No: 2023-10349]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0612; FRL-10972-01-OCSPP]

D-Glucopyranose, oligomeric, maleates, decyl octyl glycosides,
sulfonated, potassium salts; D-glucopyranose, oligomeric, maleates,
C10-16-alkyl glycosides, sulfonated, potassium salts; and D-
glucopyranose, oligomeric, maleates, C9-11-branched and linear alkyl
glycosides, sulfonated, potassium salts; Exemptions From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of D-glucopyranose, oligomeric, maleates,
decyl octyl glycosides, sulfonated, potassium salts; D-glucopyranose,
oligomeric, maleates, C10-16-alkyl glycosides, sulfonated, potassium
salts; and D-glucopyranose, oligomeric, maleates, C9-11-branched and
linear alkyl glycosides, sulfonated, potassium salts when used as inert
ingredients (surfactants) pre- and post-harvest. Lamberti USA, Inc.
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting establishment of exemptions from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of D-glucopyranose,
oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium
salts; D-glucopyranose, oligomeric, maleates, C10-16-alkyl glycosides,
sulfonated, potassium salts; and D-glucopyranose, oligomeric, maleates,
C9-11-branched and linear alkyl glycosides, sulfonated, potassium
salts, when used in accordance with the terms of these exemptions.

DATES: This regulation is effective May 18, 2023. Objections and
requests for hearings must be received on or before July 17, 2023 and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The dockets for these actions, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0612, are available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP docket is<PHONE_NUMBER>. Please review the
visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:

 Crop production (NAICS code 111).
 Animal production (NAICS code 112).
 Food manufacturing (NAICS code 311).
 Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Federal Register Office's e-CFR site at https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0612, in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 17, 2023. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0612, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets#express.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of June 22, 2022 (87 FR 37287) (FRL-9410-
02-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11613) by Spring Regulatory Sciences, on behalf of Lamberti-USA, Inc.
(Lamberti), 161 Washington Street, Conshohocken, PA 19428. The petition
requested that 40 CFR 180.910 be amended by establishing exemptions
from the requirement of a tolerance for residues of D-glucopyranose,
oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium
salts (CAS Reg. No. 2585031-35-0); D-glucopyranose, oligomeric,
maleates, C10-16-alkyl glycosides, sulfonated, potassium salts (CAS
Reg. No. 2587364-77-8); and D-glucopyranose, oligomeric, maleates, C9-
11-branched and linear alkyl glycosides, sulfonated, potassium salts
(CAS Reg. No, 1228577-37-4) when used as inert ingredients
(surfactants) in pesticide formulations pre- and post-harvest. That
document referenced a summary of the petition prepared by Lamberti,
which is available in the docket at https://www.regulations.gov. There
were no comments received in response to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. When making a safety determination for an
exemption from the requirement of a tolerance, FFDCA section
408(c)(2)(B) directs EPA to take into account the considerations in
section 408(b)(2)(C) and (D). Section 408(b)(2)(C) of FFDCA requires
EPA to give special consideration to exposure of infants and children
to the pesticide chemical residue in establishing a tolerance or
exemption and to ``ensure that there is a reasonable certainty that no
harm will result to infants and children from aggregate exposure to the
pesticide chemical residue . . . .'' Section 408(b)(2)(D) lists other
factors for EPA's consideration in making safety determinations, e.g.,
the validity, completeness, and reliability of available data, nature
of toxic effects, available information concerning the cumulative
effects of the pesticide chemical and other substances with a common
mechanism of toxicity, and available information concerning aggregate
exposure levels to the pesticide chemical and other related substances,
among other factors.
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of these
actions. EPA has sufficient data to assess the hazards of and to make a
determination on

aggregate exposure for D-glucopyranose, oligomeric, maleates, decyl
octyl glycosides, sulfonated, potassium salts; D-glucopyranose,
oligomeric, maleates, C10-16-alkyl glycosides, sulfonated, potassium
salts; and D-glucopyranose, oligomeric, maleates, C9-11-branched and
linear alkyl glycosides, sulfonated, potassium salts, including
exposure resulting from the exemptions established by this action.
These three chemicals are potassium salts of alkyl (C8-C20)
polyglucoside esters (AGEs) and are herein referred to as the AGE
potassium salts. EPA's assessment of exposures and risks associated
with the AGE potassium salts follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by the AGE potassium salts as well as the
no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies are discussed in
this unit.
    The toxicological database of the AGE potassium salts is supported
by data used for the Agency's 2015 evaluation of two AGE sodium salts
and one AGE lactate (80 FR 31481, June 3, 2015). When EPA previously
reviewed those AGEs, limited data were available, and the Agency
determined that it would be appropriate to bridge to data for similar
chemicals. EPA has determined that a similar approach is appropriate
for the three AGE potassium salts because of the similarities in the
manufacturing processes, functional groups/structure, composition,
physical/chemical properties, and expected toxicity of these chemicals
to those previously reviewed.
    The AGEs are reaction products of glucose and fatty acids in which
the alcohol moiety is attached to the polyglucoside by a [beta]-
glucosides linkage. Alkyl polyglucoside is the first degradation
product in the biodegradation pathway of the AGEs, and toxicity data
for alkyl polyglucoside are very similar for the different alcohol
chain lengths in the range C8-C20. The toxicity profile of the AGE
potassium salts is therefore based upon data considered in the previous
risk assessment for AGE sodium salts and AGE lactate where the alcohol
component of the AGE substances is in the same C8-C20 range and is
considered appropriate for read across purposes.
    Specifically, EPA considered data for D-glucopyranose, oligomeric,
6-(dihydrogen 2-hydroxy-1,2,3-propanetricarboxylate), 1-(coco alky)
ethers, sodium salts (CAS No. 151911-51-2); D-glucopyranose,
oligomeric, 6-(hydrogen 2-sulfobutanedioate), 1-(coco alkyl) ethers,
sodium salts (CAS No. 151911-53-4); D-glucopyranose, oligomeric, 6-
[hydrogen (2R, 3R)-2,3-dihydroxybutanedioate], 1-(coco alkyl) ethers,
sodium salts (CAS No. 151911-52-3); and D-Glucopyranose, oligomeric,
maleates, C9-11-branched and linear alkyl glycosides, sulfonated,
sodium salts (CAS No. 1228577-41-0), as well as the metabolites
disodium sulfosuccinate and other sulfosuccinates.
    In acute studies, the oral lethal dose, LD50 for the
AGEs was >5,000 milligrams/kilogram (mg/kg). There is no available data
regarding acute exposure via the dermal, eye or inhalation routes.
Repeat dose studies were conducted with alkyl polyglucosides and
organic acids (metabolites) in which no toxicity was seen at doses as
high as 1,000 mg/kg/day. No fetal, parental, or reproductive toxicity
was seen in a reproduction/developmental toxicity screening test up to
1,000 mg/kg/day. In addition, no evidence of neurotoxicity was seen in
the database. Ames studies conducted with various AGE sodium salts were
negative for mutagenicity, and there was no indication of
carcinogenicity when the Agency evaluated the carcinogenic potential of
AGEs by conducting a qualitative structure activity relationship (SAR)
using the database, DEREK Nexus Version 2.0. No structural alerts were
identified for carcinogenicity.
    Specific information on the studies reviewed and the nature of the
adverse effects caused by the AGEs can be found at https://www.regulations.gov in the documents ``IN-11613; Alkyl (C8-C20)
polyglucoside esters (AGEs) potassium salts. Human Health Risk
Assessment and Ecological Effects Assessment to Support Inert
Ingredient Approval for use in Pesticide Formulations'' in docket ID
number EPA-HQ-OPP-2021-0612, and ``PC Codes 911028, 911029, 911030:
Alkyl (C8-C20) polyglucoside Esters (AGEs); Human Health Risk
Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2014-0678.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
    The hazard profile of the AGE potassium salts is adequately
defined. These salts are rapidly hydrolyzed in intestine and liver. The
cleavage products, sugars, and long-chain alcohols enter the pathways
of lipid and carbohydrate metabolism. Based on the low acute,
subchronic, and developmental toxicity of AGEs, the body's ability to
rapidly metabolize these substances, the expected metabolites being
fatty acids and carbohydrates (which are normal constituents of the
body), and the lack of observed adverse effects for repeat dose studies
at the limit dose (1,000 mg/kg/day), no toxicological endpoint of
concern or PODs were identified. Therefore, a qualitative risk
assessment for the AGE potassium salts can be performed.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to the AGE potassium salts, EPA considered exposure under the
proposed exemptions from the

requirement of a tolerance. There are no other known food uses for
these chemicals; therefore, EPA assessed the proposed dietary exposures
from the AGE potassium salts in food as follows:
    Dietary exposure (food and drinking water) to the AGE potassium
salts may occur following ingestion of foods with residues from their
use in accordance with these exemptions. However, a quantitative
dietary exposure assessment was not conducted since a toxicological
endpoint for risk assessment was not identified.
    2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables). AGE
potassium salts may be present in pesticide and non-pesticide products
that may be used in and around the home, including personal care
products such as antiperspirants, shampoos, conditioners, and
moisturizers. However, a quantitative residential exposure assessment
was not conducted since a toxicological endpoint for risk assessment
was not identified.
    3. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Based on the lack of toxicity in the available database, EPA has
not found the AGE potassium salts to share a common mechanism of
toxicity with any other substances, and the AGE potassium salts do not
appear to produce a toxic metabolite produced by other substances. For
the purposes of these tolerance exemptions, therefore, EPA has assumed
that AGE potassium salts do not have a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
safety factor. In applying this provision, EPA either retains the
default value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    Based on an assessment of surrogate data for the AGE potassium
salts, EPA has concluded that there are no toxicological endpoints of
concern for the U.S. population, including infants and children.
Because there are no threshold effects associated with the AGE
potassium salts, EPA conducted a qualitative assessment. As part of
that assessment, the Agency did not use safety factors for assessing
risk, and no additional safety factor is needed for assessing risk to
infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children, from aggregate
exposure to the AGE potassium salt residues.

V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing exemptions from the requirement of a
tolerance without any numerical limitation.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are
established for residues of D-glucopyranose, oligomeric, maleates,
decyl octyl glycosides, sulfonated, potassium salts (CAS Reg. No.
2585031-35-0); D-glucopyranose, oligomeric, maleates, C10-16-alkyl
glycosides, sulfonated, potassium salts (CAS Reg. No. 2587364-77-8);
and D-glucopyranose, oligomeric, maleates, C9-11-branched and linear
alkyl glycosides, sulfonated, potassium salts (CAS Reg. No. 1228577-37-
4) when used as inert ingredients (surfactants) in pesticide
formulations applied pre- and post-harvest under 40 CFR 180.910.

VII. Statutory and Executive Order Reviews

    This action establishes exemptions from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001), or Executive Order 13045, entitled ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemptions in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the National Government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000), do not apply to this action. In addition,
this action does not impose any enforceable duty or

contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: May 10, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, the EPA amends
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.910, amend Table 1 to 180.910 by adding, in
alphabetical order, entries for ``D-glucopyranose, oligomeric,
maleates, C10-16-alkyl glycosides, sulfonated, potassium salts (CAS
Reg. No. 2587364-77-8)'', ``D-glucopyranose, oligomeric, maleates, C9-
11-branched and linear alkyl glycosides, sulfonated, potassium salts
(CAS Reg. No. 1228577-37-4)'', and ``D-glucopyranose, oligomeric,
maleates, decyl octyl glycosides, sulfonated, potassium salts (CAS Reg.
No. 2585031-35-0)'' to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

                           Table 1 to 180.910
------------------------------------------------------------------------
       Inert ingredients             Limits                Uses
------------------------------------------------------------------------

                              * * * * * * *
D-glucopyranose, oligomeric,     ..............  Surfactant.
 maleates, C10-16-alkyl
 glycosides, sulfonated,
 potassium salts (CAS Reg. No.
 2587364-77-8).
D-glucopyranose, oligomeric,     ..............  Surfactant.
 maleates, C9-11-branched and
 linear alkyl glycosides,
 sulfonated, potassium salts
 (CAS Reg. No. 1228577-37-4).
D-glucopyranose, oligomeric,     ..............  Surfactant.
 maleates, decyl octyl
 glycosides, sulfonated,
 potassium salts (CAS Reg. No.
 2585031-35-0).

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2023-10349 Filed 5-17-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 25, 2006 (Volume 71, Number 16)]
[Notices]
[Page 4189-4190]
[DOCID:fr25ja06-121]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53139; File No. SR-Phlx-2005-67]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Order Granting Approval of a Proposed Rule Change and Amendment No. 1
Thereto Relating to the Maintenance, Retention, and Furnishing of
Books, Records, and Other Information Regarding Payment for Order Flow

January 18, 2006.
    On November 3, 2005, the Philadelphia Stock Exchange, Inc.
(``Phlx'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to amend Phlx Rule 760
(Maintenance, Retention and Furnishing of Books, Records and Other
Information) to incorporate recent changes to the Exchange's payment
for order flow program. On November 22, 2005, the Exchange filed
Amendment No. 1 to the proposed rule change.\3\ The proposed rule
change, as amended, was published for comment in the Federal Register
on December 14, 2005.\4\ The Commission received no comments on the
proposal. This order approves the proposed rule change, as amended.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 provided clarifying language to Phlx Rule
760 and the purpose section of the filing.
    \4\ Securities Exchange Act Release No. 52903 (December 7,
2005), 70 FR 74082 (December 14, 2005) (SR-Phlx-2005-67).
---------------------------------------------------------------------------

    The Exchange recently amended its payment for order flow program
for trades settling on or after October 1, 2005 (``October
program'').\5\ The Exchange represented that Registered Options Traders
who receive electronically-delivered orders directed to them
(``Directed ROTs'') may, pursuant to the October program, direct the
Exchange to make payments to order flow providers on their behalf.\6\
Thus, the Exchange proposed to amend the Supplementary Material to Phlx
Rule 760 to clarify that these Directed ROTs would now be required to
retain records relating to payment for order flow arrangements.\7\ The
Exchange also proposed to amend the Supplementary Material to Phlx Rule
760 because the Exchange's current payment for order flow program no
longer tracks payments to order flow providers on an option by option
basis. In addition, the Exchange noted that specialists and specialist
units no longer need to maintain records relating to the use, transfer,
and distribution of payment for order flow funds because they would now
direct the Exchange to make payments to order flow providers on their
behalf. The Exchange further proposed to specifically request that
books and records regarding the rate (whether on a per contract or flat
fee basis) that is paid to order flow providers and the basis for the
amount that Directed ROTs, specialists, and specialist units direct the
Exchange to pay to order flow providers be maintained and made
available as may be requested by the Exchange.
---------------------------------------------------------------------------

    \5\ The October program is in effect as a pilot program that is
scheduled to expire on May 27, 2006. See Securities Exchange Act
Release No. 52568 (October 6, 2005), 70 FR 60120 (October 14, 2005)
(SR-Phlx-2005-58).
    \6\ The Exchange represented that under previous payment for
order flow programs, specialist units requested reimbursement from
the Exchange for monies they paid to order flow providers. Pursuant
to the October program, the available payment for order flow funds
would be disbursed by the Exchange according to the instructions of
the specialist units and Directed ROTs.
    \7\ The Exchange represented that specialists/specialist units
are already specifically required to maintain these books and
records.
---------------------------------------------------------------------------

    The Commission finds that the proposed rule change, as amended, is
consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities exchange.\8\
The Commission believes that the proposed rule change, as amended, is
consistent with section 6(b)(5) of the Act \9\ in that this proposal 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 transaction 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.
The Commission believes that the proposed rule change clarifies the
parties that must maintain records relating to payment for order flow
arrangements and the nature of the records to be maintained. The
Commission also believes that the proposed rule change would assist the
Exchange in determining whether its payment for order flow program is
being carried out in accordance with the Exchange's requirements.
---------------------------------------------------------------------------

    \8\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition, and capital
formation. 15 U.S.C. 78c(f).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    It Is Therefore Ordered, pursuant to section 19(b)(2) of the
Act,\10\ that the proposed rule change (SR-Phlx-2005-67), as amended,
is approved.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2).
    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. E6-924 Filed 1-24-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 7 (Thursday, January 10, 2013)]
[Rules and Regulations]
[Pages 2211-2213]
[FR Doc No: 2013-00177]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2012-0781; FRL-9768-2]

Determination of Attainment for the Yuba City-Marysville
Nonattainment Area for the 2006 Fine Particle Standard; California;
Determination Regarding Applicability of Clean Air Act Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is taking final action to determine that the Yuba City-
Marysville nonattainment area in California has attained the 2006 24-
hour fine particle (PM2.5) National Ambient Air Quality
Standard (NAAQS). This determination is based upon complete, quality-
assured, and certified ambient air monitoring data showing that this
area has monitored attainment of the 2006 24-hour PM2.5
NAAQS based on the 2009-2011 monitoring period. Based on the above
determination, the requirements for this area to submit an attainment
demonstration, together with reasonably available control measures
(RACM), a reasonable further progress (RFP) plan, and contingency
measures for failure to meet RFP and attainment deadlines are suspended
for so long as the area continues to attain the 2006 24-hour
PM2.5 NAAQS.

DATES: This rule is effective on February 11, 2013.

ADDRESSES: EPA has established docket number EPA-R09-OAR-2012-0781 for
this action. Generally, documents in the docket for this action are
available electronically at www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California. While all
documents in the docket are listed at www.regulations.gov, some
information may be publicly available only at the hard copy location
(e.g., copyrighted material, large maps, multi-volume reports), and
some may not be publicly available in either location (e.g.,

Confidential Business Information). To inspect the hard copy materials,
please schedule an appointment during normal business hours with the
contact listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: John Ungvarsky,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, wherever ``we'',
``us'' or ``our'' are used, we mean EPA.

Table of Contents

I. Summary of Proposed Action
II. Public Comments and EPA Responses
III. EPA's Final Action
IV. Statutory and Executive Order Reviews

I. Summary of Proposed Action

    On October 30, 2012 (77 FR 65646), EPA proposed to determine that
the Yuba City-Marysville nonattainment area \1\ has attained the 2006
24-hour NAAQS \2\ for fine particles (generally referring to particles
less than or equal to 2.5 micrometers in diameter, PM2.5).
---------------------------------------------------------------------------

    \1\ The Yuba City-Marysville PM2.5 nonattainment area
includes Sutter County and the southwestern two-thirds of Yuba
County. This nonattainment area lies within the Sacramento Valley
Air Basin and lies between the Chico PM2.5 nonattainment
area to the north and the Sacramento PM2.5 nonattainment
area to the south.
    \2\ The 2006 24-hour PM2.5 NAAQS is 35 micrograms per
cubic meter ([micro]g/m\3\), based on a 3-year average of the 98th
percentile of 24-hour concentrations.
---------------------------------------------------------------------------

    In our proposed rule, we explained how EPA makes an attainment
determination for the 2006 24-hour PM2.5 NAAQS by reference
to complete, quality-assured data gathered at a State and Local Air
Monitoring Station(s) (SLAMS) and entered into EPA's Air Quality System
(AQS) database and by reference to 40 CFR 50.13 (``National primary and
secondary ambient air quality standards for PM2.5'') and
appendix N to [40 CFR] part 50 (``Interpretation of the National
Ambient Air Quality Standards for PM2.5''). EPA proposed the
determination of attainment for the Yuba City-Marysville area based
upon a review of the monitoring network operated by the California Air
Resources Board (CARB) and the data collected at the one monitoring
site operating during the most recent complete three-year period (i.e.,
2009 to 2011). Based on this review, EPA found that complete, quality-
assured and certified data for the Yuba City-Marysville area showed
that the 24-hour design value for the 2009-2011 period was equal to or
less than 35 [micro]/m\3\ at the monitor site. See the data summary
table on page 65648 of the October 30, 2012 proposed rule. We also
noted that preliminary data available in AQS for 2012 indicates that
the Yuba City-Marysville area continues to attain the NAAQS.
    In our proposed rule, based on the proposed determination of
attainment, we also proposed to apply EPA's Clean Data Policy to the
2006 PM2.5 NAAQS and thereby suspend the requirements for
this area to submit an attainment demonstration, associated reasonably
available control measures (RACM), a reasonable further progress (RFP)
plan, and contingency measures for so long as the area continues to
attain the 2006 24-hour PM2.5 NAAQS. See pages 65648-65650
of our October 30, 2012 proposed rule. In proposing to apply the Clean
Data Policy to the 2006 PM2.5 NAAQS, we explained how we are
applying the same statutory interpretation with respect to the
implications of clean data determinations that the Agency has long
applied in regulations for the 1997 8-hour ozone and PM2.5
NAAQS and in individual rulemakings for the 1-hour ozone,
PM10 and lead NAAQS.
    Please see the October 30, 2012 proposed rule for more detailed
information concerning the PM2.5 NAAQS, designations of
PM2.5 nonattainment areas, the regulatory basis for
determining attainment of the NAAQS, CARB's PM2.5 monitoring
network, EPA's review and evaluation of the data, and the rationale and
implications for application of the Clean Data Policy to the 2006
PM2.5 NAAQS.

II. Public Comments and EPA Responses

    EPA's proposed rule provided a 30-day public comment period. During
this period, we received no comments.

III. EPA's Final Action

    For the reasons provided in the proposed rule and summarized
herein, EPA is taking final action to determine that the Yuba City-
Marysville nonattainment area in California has attained the 2006 24-
hour PM2.5 NAAQS based on the most recent three years of
complete, quality-assured, and certified data in AQS for 2009-2011.
Preliminary data available in AQS for 2012 show that this area
continues to attain the standard.
    EPA is also taking final action, based on the above determination
of attainment, to suspend the requirements for the Yuba City-Marysville
nonattainment area to submit an attainment demonstration and associated
RACM, a RFP plan, contingency measures, and any other planning SIPs
related to attainment of the 2006 PM2.5 NAAQS for so long as
the area continues to attain the 2006 PM2.5 NAAQS. EPA's
final action is consistent and in keeping with its long-held
interpretation of CAA requirements, as well as with EPA's regulations
for similar determinations for ozone (see 40 CFR 51.918) and the 1997
fine particulate matter standards (see 40 CFR 51.1004(c)).
    Today's final action does not constitute a redesignation of the
Yuba City-Marysville nonattainment area to attainment for the 2006 24-
hour PM2.5 NAAQS under CAA section 107(d)(3) because we have
not yet approved a maintenance plan for the Yuba City-Marysville
nonattainment area as meeting the requirements of section 175A of the
CAA or determined that the area has met the other CAA requirements for
redesignation. The classification and designation status in 40 CFR part
81 remain nonattainment for this area until such time as EPA determines
that California has met the CAA requirements for redesignating the Yuba
City-Marysville nonattainment area to attainment.
    If the Yuba City-Marysville nonattainment area continues to monitor
attainment of the 2006 PM2.5 NAAQS, the requirements for the
area to submit an attainment demonstration and associated RACM, a RFP
plan, contingency measures, and any other planning requirements related
to attainment of the 2006 PM2.5 NAAQS will remain suspended.
If after today's action EPA subsequently determines, after notice-and-
comment rulemaking in the Federal Register, that the area has violated
the 2006 PM2.5 NAAQS, the basis for the suspension of the
attainment planning requirements for the area would no longer exist,
and the area would thereafter have to address such requirements.

IV. Statutory and Executive Order Reviews

    This final action makes a determination of attainment based on air
quality and suspends certain federal requirements, and thus, this
action would not impose additional requirements beyond those imposed by
state law. For this reason, the final 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 disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this final action does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP obligations discussed herein do not apply to Indian
Tribes, and thus this action will not impose substantial direct costs
on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by March 11, 2013. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Particulate matter, Nitrogen oxides, Sulfur oxides,
Reporting and recordkeeping requirements.

    Dated: December 18, 2012.
Jared Blumenfeld,
Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for Part 52 continues to read as follows:

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

Subpart F--California

0
2. In Sec.  52.247, paragraph (b) is added to read as follows:

Sec.  52.247  Control Strategy and Regulations: Fine Particle Matter.

* * * * *
    (b) Determination of Attainment: Effective February 11, 2013, EPA
has determined that, based on 2009 to 2011 ambient air quality data,
the Yuba City-Marysville PM2.5 nonattainment area has
attained the 2006 24-hour PM2.5 NAAQS. This determination
suspends the requirements for this area to submit an attainment
demonstration, associated reasonably available control measures, a
reasonable further progress plan, contingency measures, and other
planning SIPs related to attainment for as long as this area continues
to attain the 2006 24-hour PM2.5 NAAQS. If EPA determines,
after notice-and-comment rulemaking, that this area no longer meets the
2006 PM2.5 NAAQS, the corresponding determination of
attainment for that area shall be withdrawn.

[FR Doc. 2013-00177 Filed 1-9-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 4, 2007 (Volume 72, Number 2)]
[Notices]
[Page 355]
[DOCID:fr04ja07-57]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of Digital Concepts International, Inc., Integrated
Homes, Inc., Lighthouse Fast Ferry, Inc. and Wannigan Capital Corp.;
Order of Suspension of Trading

December 28, 2006.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Digital Concepts International, Inc., because it is delinquent in its
periodic filing obligations under Section 13(a) of the Securities
Exchange Act of 1934 (``Exchange Act''), and Rules 13a-1 and 13a-13
thereunder, having never filed a periodic report after its Form 10-SB
filed on March 8, 2002, and amended on July 2, 2002, went effective
registering its securities.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Integrated Homes, Inc., because it is delinquent in its periodic filing
obligations under Section 13(a) of the Exchange Act, and Rules 13a-1
and 13a-13 thereunder, having not filed a periodic report after its
Form 10-SB filed on October 13, 2000, went effective registering its
securities.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Lighthouse Fast Ferry, Inc., because it is delinquent in its periodic
filing obligations under Section 13(a) of the Exchange Act, and Rules
13a-1 and 13a-13 thereunder, having not filed a periodic report since
the period ending June 30, 2002.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Wannigan Capital Corp. (f/k/a ThermoElastic Technologies, Inc.),
because it is delinquent in its periodic filing obligations under
Section 13(a) of the Exchange Act, and Rules 13a-1 and 13a-13
thereunder, having not filed a periodic report since the period ending
September 30, 2002.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies.
    Therefore, it is ordered, pursuant to Section 12(k) of the Exchange
Act, that trading in the above-listed companies is suspended for the
period from 9:30 a.m. EST on December 28, 2006, through 11:59 p.m. EST
on January 11, 2007.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 06-9967 Filed 12-28-06; 11:06 am]

BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 186 (Wednesday, September 29, 2021)]
[Notices]
[Pages 54003-54005]
[FR Doc No: 2021-21112]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93113; File No. SR-Phlx-2021-55]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the
Exchange's Pricing Schedule at Equity 7, Section 3(a)

September 23, 2021.
    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 September 13, 2021, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III, below,
which Items have been prepared by the Exchange. 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 Exchange proposes to amend the Exchange's pricing schedule at
Equity 7, Section 3(a), as described further below.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/phlx/rules, 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 Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is to amend the Exchange's
schedule of credits, at Equity 7, Section 3(a). Specifically, the
Exchange proposes to eliminate an existing credit of $0.0033 per share
executed to members that provide liquidity for displayed quotes/orders
executed. The Exchange currently provides a $0.0033 per share executed
credit for displayed quotes/orders executed at or between $1.00 and
$5.00 per share.
    The Exchange proposes to eliminate the existing credit as it has
not been effective in accomplishing its intended purpose, which is to
incent members to increase their liquidity adding activity. This credit
has served to neither sufficiently increase activity on, nor improved
the market quality of, the Exchange. The Exchange therefore proposes to
eliminate it.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\3\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\4\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers. The proposal is also consistent with
Section 11A of the Act relating to the establishment of the national
market system for securities.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(4) and (5).

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

The Proposal Is Reasonable
    The Exchange's proposal is reasonable in several respects. As a
threshold matter, the Exchange is subject to significant competitive
forces in the market for equity securities transaction services that
constrain its pricing determinations in that market. The fact that this
market is competitive has long been recognized by the courts. In
NetCoalition v. Securities and Exchange Commission, the D.C. Circuit
stated as follows: ``[n]o one disputes that competition for order flow
is `fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their order-routing agents, have a wide range of choices of
where to route orders for execution'; [and] `no exchange can afford to
take its market share percentages for granted' because `no exchange
possesses a monopoly, regulatory or otherwise, in the execution of
order flow from broker dealers'. . . .'' \5\
---------------------------------------------------------------------------

    \5\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).
---------------------------------------------------------------------------

    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. In Regulation
NMS, while adopting a series of steps to improve the current market
model, the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \6\
---------------------------------------------------------------------------

    \6\ Securities Exchange Act Release No. 51808 (June 9, 2005), 70
FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
---------------------------------------------------------------------------

    Numerous indicia demonstrate the competitive nature of this market.
For example, clear substitutes to the Exchange exist in the market for
equity security transaction services. The Exchange is only one of
several equity venues to which market participants may direct their
order flow. Competing equity exchanges offer similar tiered pricing
structures to that of the Exchange, including schedules of rebates and
fees that apply based upon members achieving certain volume thresholds.
    Within this environment, market participants can freely and often
do shift their order flow among the Exchange and competing venues in
response to changes in their respective pricing schedules. The credit
was an attempt to increase liquidity but was not as successful as the
Exchange expected.
    The Exchange believes that it is reasonable to eliminate its
existing $0.0033 per share executed credit for quotes/orders executed
at or between $1.00 and $5.00 per share. As discussed above, the
Exchange has observed that the credit has served to neither
meaningfully increase activity on, nor improved the market quality of,
the Exchange. Under these circumstances, the Exchange believes it is
reasonable to eliminate the credit and reallocate its limited resources
to more effective incentive programs.
    The Exchange notes that those market participants that are
dissatisfied with the proposal is free to shift their order flow to
competing venues that offer more generous pricing or less stringent
qualifying criteria.
The Proposal Is an Equitable Allocation of Credits
    The Exchange believes its proposal will allocate its charges and
credits fairly among its market participants.
    The Exchange believes that is an equitable allocation to eliminate
its existing $0.0033 per share executed credit for quotes/orders
executed at or between $1.00 and $5.00 per share. As discussed above,
the credit has served to neither meaningfully increase activity on the
Exchange nor improve the quality of the Exchange. Under these
circumstances, the Exchange believes it is equitable to eliminate the
credit and reallocate its limited resources to more effective incentive
programs.
    Any participant that is dissatisfied with the proposal is free to
shift their order flow to competing venues that provide more generous
pricing or less stringent qualifying criteria.
The Proposal Is Not Unfairly Discriminatory
    The Exchange believes that its proposal is not unfairly
discriminatory. As an initial matter, the Exchange believes that
nothing about its tiered pricing model is inherently unfair; instead,
it is a rational pricing model that is well-established and ubiquitous
in today's economy among firms in various industries--from co-branded
credit cards to grocery stores to cellular telephone data plans--that
use it to reward the loyalty of their best customers that provide high
levels of business activity and incent other customers to increase the
extent of their business activity. It is also a pricing model that the
Exchange and its competitors have long employed with the assent of the
Commission. It is fair because it enhances price discovery and improves
the overall quality of the equity markets. The proposal is not unfairly
discriminatory because the change applies to all market participants.
    The proposal to eliminate one of the Exchange's transaction credits
is not unfairly discriminatory because the Exchange has observed that
the credit has served to neither meaningfully increase activity on, nor
improved the market quality of, the Exchange. Under these
circumstances, the Exchange believes it is reasonable to eliminate the
credit and reallocate its limited resources to more effective incentive
programs. The Exchange has limited resources with which to apply to
incentives, and it must allocate those limited resources in a manner
that prioritizes areas of greatest need and potential effect.
    Any participant that is dissatisfied with the proposal is free to
shift their order flow to competing venues that provide more generous
pricing or less stringent qualifying criteria.

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 not necessary or appropriate in
furtherance of the purposes of the Act.
Intramarket Competition
    The Exchange does not believe that its proposal will place any
category of Exchange participant at a competitive disadvantage.
    The proposed elimination of one of the Exchange's existing
transaction credits will have minimal competitive effect insofar as the
Exchange offers other means to attain other credit tiers.
    The Exchange notes that its members are free to trade on other
venues to the extent they believe that the remaining credits are not
attractive. As one can observe by looking at any market share chart,
price competition between exchanges is fierce, with liquidity and
market share moving freely between exchanges in reaction to fee and
credit changes.
Intermarket Competition
    In terms of inter-market competition, the Exchange notes that it
operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be excessive, or rebate opportunities available at
other venues to be more favorable. In such an environment, the Exchange
must continually adjust its

credits and fees to remain competitive with other exchanges and with
alternative trading systems that have been exempted from compliance
with the statutory standards applicable to exchanges. Because
competitors are free to modify their own credits and fees in response,
and because market participants may readily adjust their order routing
practices, the Exchange believes that the degree to which credit or fee
changes in this market may impose any burden on competition is
extremely limited.
    If the change proposed herein is unattractive to market
participants, it is likely that the Exchange will lose market share as
a result. Accordingly, the Exchange does not believe that the proposed
change will impair the ability of members or competing order execution
venues to maintain their competitive standing in the financial markets.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\7\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2021-55 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-Phlx-2021-55. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2021-55 and should be submitted on
or before October 20, 2021.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-21112 Filed 9-28-21; 8:45 am]
BILLING CODE 8011-01-P