[Federal Register Volume 84, Number 70 (Thursday, April 11, 2019)]
[Notices]
[Pages 14706-14708]
[FR Doc No: 2019-07152]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85523; File No. SR-NYSE-2019-17]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Extend the Current Pilot Program Related to Rule 7.10, Clearly
Erroneous Executions, and Rule 128, Clearly Erroneous Executions for
NYSE Equities

April 5, 2019.
    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 April 3, 2019, New York Stock Exchange LLC (``NYSE'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the 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 extend the current pilot program related
to Rule 7.10, Clearly Erroneous Executions, and Rule 128, Clearly
Erroneous Executions for NYSE Equities, to the close of business on
October 18, 2019. The proposed rule change is available on the
Exchange's website at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The purpose of the proposed rule change is to extend the current
pilot program related to Rule 7.10, Clearly Erroneous Executions, and
Rule 128, Clearly Erroneous Executions for NYSE Equities, to the close
of business on October 18, 2019. This change is being proposed in
connection with proposed amendments to the Plan to Address
Extraordinary Market Volatility (the ``Limit Up-Limit Down Plan'' or
the ``Plan'') that would allow the Plan to continue to operate on a
permanent basis.\4\
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    \4\ See Securities Exchange Act Release No. 84843 (December 18,
2018), 83 FR 66464 (December 26, 2018) (File No. 4-631)
(``Eighteenth Amendment'').
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    On September 10, 2010, the Commission approved, on a pilot basis,
changes to Rule 128 that, among other things: (i) Provided for uniform
treatment of clearly erroneous execution reviews in multi-stock events
involving twenty or more securities; and (ii) reduced the ability of
the Exchange to deviate from the objective standards set forth in the
rule.\5\ In 2013, the Exchange adopted a provision to Rule 128 designed
to address the operation of the Plan.\6\ Finally, in 2014, the Exchange
adopted two additional provisions to Rule 128 providing that: (i) A
series of transactions in a particular security on one or more trading
days may be viewed as one event if all such transactions were effected
based on the same fundamentally incorrect or grossly misinterpreted
issuance information resulting in a severe valuation error for all such
transactions; and (ii) in the event of any disruption or malfunction in
the operation of the electronic communications and trading facilities
of an Exchange, another SRO, or responsible single plan processor in
connection with the transmittal or receipt of a trading halt, an
Officer, acting on his or her own motion, shall nullify any transaction
that occurs after a trading halt has been declared by the primary
listing market for a security and before such trading halt has
officially ended according to the primary listing market.\7\ These
changes are currently scheduled to operate for a pilot period that
coincides with the pilot period for the Limit Up-Limit Down Plan,\8\
including any extensions to the pilot period for the Plan.\9\ In March
2018, the Exchange adopted Rule 7.10, Clearly Erroneous Executions,
governing executions on its Pillar Trading Platform.\10\
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    \5\ See Securities Exchange Act Release No. 62886 (Sept. 10,
2010), 75 FR 56613 (Sept. 16, 2010) (SR-NYSE-2010-47).
    \6\ See Securities Exchange Act Release No. 68804 (Feb. 1,
2013), 78 FR 8677 (Feb. 6, 2013) (SR-NYSE-2013-11).
    \7\ See Securities Exchange Act Release No. 72434 (June 19,
2014), 79 FR 36110 (June 25, 2014) (SR-NYSE-2014-22).
    \8\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012) (the ``Limit Up-Limit Down
Release'').
    \9\ See Securities Exchange Act Release No. 71821 (March 27,
2014), 79 FR 18592 (April 2, 2014) (SR-NYSE-2014-17).
    \10\ See Securities Exchange Act Release No. 82945 (March 26,
2018), 83 FR 13553 (March 29, 2018) (SR-NYSE-2017-36).
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    The Commission recently published the proposed Eighteenth Amendment
to the Plan to allow the Plan to operate on a permanent, rather than
pilot, basis. The Exchange proposes to amend Rules 7.10 and 128 to
untie the pilot program's effectiveness from that of the Plan and to
extend the pilot's effectiveness to the close of business on October
18, 2019--i.e., six months after the expiration of the current pilot
period for the Plan. If the pilot period is not either extended,
replaced or approved as permanent, the prior versions of paragraphs
(c), (e)(2), (f), and (g) shall be in effect, and the provisions of
paragraphs (i) through (k) shall be null and void.\11\ In such an
event, the remaining sections of Rules 7.10 and 128 would continue to
apply to all transactions executed on the Exchange. The Exchange
understands that the other national securities exchanges and Financial
Industry Regulatory Authority (``FINRA'') will also file similar
proposals to extend their respective clearly erroneous execution pilot

programs, the substance of which are identical to Rules 7.10 and 128.
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    \11\ See supra notes 6-8. The prior versions of paragraphs (c),
(e)(2), (f), and (g) generally provided greater discretion to the
Exchange with respect to breaking erroneous trades.
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    The Exchange does not propose any additional changes to Rules 7.10
and 128. The Exchange believes the benefits to market participants from
the more objective clearly erroneous executions rule should continue on
a limited six month pilot basis after Commission approves the Plan to
operate on a permanent basis. Assuming the Plan is approved by the
Commission to operate on a permanent, rather than pilot, basis the
Exchange intends to assess whether additional changes should also be
made to the operation of the clearly erroneous execution rules.
Extending the effectiveness of Rules 7.10 and 128 for an additional six
months should provide the Exchange and other national securities
exchanges additional time to consider further amendments to the clearly
erroneous execution rules in light of the proposed Eighteenth Amendment
to the Plan.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the requirements of Section 6(b) of the Act,\12\ in general, and
Section 6(b)(5) of the Act,\13\ in particular, in that it is designed
to remove impediments to and perfect the mechanism of a free and open
market and a national market system, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest and not to permit unfair discrimination between
customers, issuers, brokers, or dealers. The Exchange believes that the
proposed rule change promotes just and equitable principles of trade in
that it promotes transparency and uniformity across markets concerning
review of transactions as clearly erroneous. The Exchange believes that
extending the clearly erroneous execution pilot under Rules 7.10 and
128 for an additional six months would help assure that the
determination of whether a clearly erroneous trade has occurred will be
based on clear and objective criteria, and that the resolution of the
incident will occur promptly through a transparent process. The
proposed rule change would also help assure consistent results in
handling erroneous trades across the U.S. equities markets, thus
furthering fair and orderly markets, the protection of investors and
the public interest. Based on the foregoing, the Exchange believes the
amended clearly erroneous executions rule should continue to be in
effect on a pilot basis while the Exchange and the other national
securities exchanges consider and develop a permanent proposal for
clearly erroneous execution reviews.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    No 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 foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \14\ and Rule 19b-
4(f)(6) thereunder.\15\
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    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
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    A proposed rule change filed under Rule 19b-4(f)(6) \16\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \17\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposed
rule change may become effective and operative immediately upon filing.
The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest, as
it will allow the current clearly erroneous execution pilot program to
continue uninterrupted, without any changes, while the Exchange and the
other national securities exchanges consider and develop a permanent
proposal for clearly erroneous execution reviews. For this reason, the
Commission hereby waives the 30-day operative delay requirement and
designates the proposed rule change as operative upon filing.\18\
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    \16\ 17 CFR 240.19b-4(f)(6).
    \17\ 17 CFR 240.19b-4(f)(6)(iii).
    \18\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSE-2019-17 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-NYSE-2019-17. 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-NYSE-2019-17 and should be submitted on
or before May 2, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-07152 Filed 4-10-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43351-43352]
[FR Doc No: 2017-19566]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP17-488-000; CP17-489-000]

Kinetica Deepwater Express, LLC; Kinetica Energy Express, LLC;
Notice of Applications

    Take notice that on August 25, 2017 Kinetica Deepwater Express, LLC
(Kinetica Deepwater), 1001 McKinney, Suite 910, Houston, Texas 77002,
filed Docket No. CP17-488-000 an application pursuant to section 7(b)
of the Natural Gas Act (NGA) and sections 157.5, 157.7, and 157.18 of
the Commission's regulations, requesting authorization to abandon by
sale of approximately 192 miles of pipeline, 5 offshore platforms, and
measurement, separation and dehydration facilities (the Patterson
System) located in Louisiana and in state and federal waters in the
Gulf of Mexico to Kinetica Energy Express, LLC (Kinetica Energy).
    Additionally, on August 30, 2017 Kinetica Energy, 1001 McKinney,
Suite 900, Houston, Texas 77002, filed Docket No. CP17-489-000 an
application pursuant to section 7(c) of the NGA and Parts 157 and 284
of the Commission's regulations, requesting (1) authorization to
acquire, own, and operate the Patterson System facilities from Kinetica
Deepwater and (2) approval of the incremental initial rates and revised
tariff pursuant to which Kinetica Energy will provide open-access, non-
discriminatory natural gas transportation services consistent with
Commission policies.
    The applications are on file with the Commission and open to public
inspection. The filings are available for review at the Commission in
the Public Reference Room or may be viewed on the Web at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the documents. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning these applications may be directed to
Diane S. Dundee, Kinetica Energy Express, LLC, 1001 McKinney, Suite
900, Houston, Texas 77002 or by phone<PHONE_NUMBER>.
    Pursuant to section 157.9 of the Commission's rules, within 90 days
of this Notice the Commission staff will either: Complete its
environmental assessment (EA) and place it into the Commission's public
record (eLibrary) for this proceeding; or issue a Notice of Schedule
for Environmental Review. If a Notice of Schedule for Environmental
Review is issued, it will indicate, among other milestones, the
anticipated date for the Commission staff's issuance of the EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit five copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the

proceeding can ask for court review of Commission orders in the
proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit original and five copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on September 28, 2017.

    Dated: September 7, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-19566 Filed 9-14-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 189 (Monday, October 4, 2021)]
[Notices]
[Pages 54772-54774]
[FR Doc No: 2021-21483]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93147; File No. SR-CboeBZX-2021-053]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Order
Granting Approval of a Proposed Rule Change To Amend Rule 14.11(m)
(Tracking Fund Shares) To Provide for the Use of Custom Baskets
Consistent With the Exemptive Relief Issued Pursuant to the Investment
Company Act of 1940 Applicable to a Series of Tracking Fund Shares

September 28, 2021.

I. Introduction

    On August 3, 2021, Cboe BZX Exchange, Inc. (``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Exchange Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to amend BZX Rule 14.11(m)
(Tracking Fund Shares) to provide for the use of custom baskets
consistent with the exemptive relief issued pursuant to the Investment
Company Act of 1940 (``1940 Act'') \3\ applicable to a series of
Tracking Fund Shares. The proposed rule change was published for
comment in the Federal Register on August 16, 2021.\4\ The Commission
has received no comments on the proposed rule change. The Commission is
approving the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 80a.
    \4\ See Securities Exchange Act Release No. 92626 (August 10,
2021), 86 FR 45792.
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II. Description

    The Exchange proposes to amend BZX Rule 14.11(m), which permits the
listing and trading of series of Tracking Fund Shares. BZX Rule
14.11(m) currently requires that Tracking Fund Shares be issued and
redeemed in a specified aggregate minimum number in return for the
Tracking Basket \5\ and/or cash.\6\ The Exchange proposes to amend

the definition of ``Tracking Fund Share'' in BZX Rule 14.11(m)(3)(A) to
permit creations and redemptions of shares in return for a Custom
Basket in addition to the Tracking Basket, to the extent permitted by a
fund's exemptive relief.\7\ Further, the Exchange proposes to define
the term ``Custom Basket'' as a portfolio of securities that is
different from the Tracking Basket and is otherwise consistent with the
exemptive relief issued pursuant to the 1940 Act applicable to a series
of Tracking Fund Shares.\8\ The Exchange also proposes to amend the
definition of ``Reporting Authority'' in BZX Rule 14.11(m)(3)(C) to
include Custom Baskets among the types of information for which the
Reporting Authority designated for a particular series of Tracking Fund
Shares will be the official source for calculating and reporting such
information.\9\
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    \5\ The term ``Tracking Basket'' means the identities and
quantities of the securities and other assets included in a basket
that is designed to closely track the daily performance of the Fund
Portfolio, as provided in the exemptive relief under the 1940 Act
applicable to a series of Tracking Fund Shares. See BZX Rule
14.11(m)(3)(E). The term ``Fund Portfolio'' means the identities and
quantities of the securities and other assets held by the investment
company registered under the 1940 Act (``Investment Company'') that
will form the basis for the Investment Company's calculation of net
asset value (``NAV'') at the end of the business day. See BZX Rule
14.11(m)(3)(B).
    \6\ See BZX Rule 14.11(m)(3)(A) (defining the term ``Tracking
Fund Share'').
    \7\ See proposed BZX Rule 14.11(m)(3)(A) (defining ``Tracking
Fund Share'' as a security that: (i) Represents an interest in an
Investment Company organized as an open-end management investment
company, that invests in a portfolio of securities selected by the
Investment Company's investment adviser consistent with the
Investment Company's investment objectives and policies; (ii) is
issued in a specified aggregate minimum number in return for a
deposit of a specified Tracking Basket or Custom Basket, as
applicable, and/or a cash amount with a value equal to the next
determined NAV; (iii) when aggregated in the same specified minimum
number, may be redeemed at a holder's request, which holder will be
paid a specified Tracking Basket or Custom Basket, as applicable,
and/or a cash amount with a value equal to the next determined NAV;
and (iv) the portfolio holdings for which are disclosed within at
least 60 days following the end of every fiscal quarter).
    \8\ See proposed BZX Rule 14.11(m)(3)(F).
    \9\ See proposed BZX Rule 14.11(m)(3)(C) (defining ``Reporting
Authority'' in respect of a particular series of Tracking Fund
Shares as the Exchange, an institution, or a reporting service
designated by the Exchange or by the exchange that lists a
particular series of Tracking Fund Shares (if the Exchange is
trading such series pursuant to unlisted trading privileges) as the
official source for calculating and reporting information relating
to such series, including, but not limited to, the Tracking Basket;
the Fund Portfolio; the Custom Basket; the amount of any cash
distribution to holders of Tracking Fund Shares, NAV, or other
information relating to the issuance, redemption or trading of
Tracking Fund Shares).
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    The Exchange proposes to amend BZX Rule 14.11(m)(4) to incorporate
specific initial and continued listing criteria relating to Custom
Baskets. Specifically, the Exchange proposes to add a new initial
listing requirement to stipulate that the Exchange will obtain a
representation from the issuer of each series of Tracking Fund Shares
that the issuer and any person acting on behalf of the series of
Tracking Fund Shares will comply with Regulation Fair Disclosure under
the Exchange Act (``Regulation FD''),\10\ including with respect to any
Custom Basket.\11\ The Exchange also proposes to add a new continued
listing requirement that, with respect to each Custom Basket utilized
by a series of Tracking Fund Shares, each business day, before the
opening of trading in Regular Trading Hours,\12\ the Investment Company
shall make publicly available on its website the composition of any
Custom Basket transacted on the previous business day, except a Custom
Basket that differs from the applicable Tracking Basket only with
respect to cash.\13\
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    \10\ 17 CFR 243.100.
    \11\ See proposed BZX Rule 14.11(m)(4)(A)(ii)(c). BZX Rule
14.11(m)(4)(A)(ii) currently provides that the Exchange will obtain
a representation from the issuer of each series of Tracking Fund
Shares that the NAV per share for the series will be calculated
daily and that the NAV, the Tracking Basket, and the Fund Portfolio
will be made available to all market participants at the same time
when disclosed. The current requirements would be designated as BZX
Rule 14.11(m)(4)(A)(ii)(a) and (b).
    \12\ The term ``Regular Trading Hours'' means the time between
9:30 a.m. and 4:00 p.m. Eastern Time. See BZX Rule 1.5(w).
    \13\ See proposed BZX Rule 14.11(m)(4)(B)(ii). The Exchange also
proposes to renumber the remainder of BZX Rule 14.11(m)(4)(B).
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    Finally, the Exchange proposes to amend BZX Rules 14.11(m)(2)(E)
and (F), which contain requirements that specified parties must erect
and maintain ``fire walls'' with respect to access to information
concerning the Fund Portfolio and Tracking Basket and enact procedures
designed to prevent the use and dissemination of material nonpublic
information regarding the Fund Portfolio and Tracking Basket, so that
these requirements would also cover information concerning Custom
Baskets. As proposed to be amended, BZX Rule 14.11(m)(2)(E) would
require that, if the investment adviser to the Investment Company
issuing Tracking Fund Shares is registered as a broker-dealer or is
affiliated with a broker-dealer, such investment adviser will erect and
maintain a ``fire wall'' between the investment adviser and personnel
of the broker-dealer or broker-dealer affiliate, as applicable, with
respect to access to information concerning the composition of and/or
changes to the Fund Portfolio, the Tracking Basket, and/or the Custom
Basket, as applicable. In addition, any person related to the
investment adviser or Investment Company who makes decisions pertaining
to the Investment Company's Fund Portfolio, the Tracking Basket, and/or
the Custom Basket or has access to nonpublic information regarding the
Fund Portfolio, the Tracking Basket, and/or the Custom Basket, as
applicable, or changes thereto, must be subject to procedures designed
to prevent the use and dissemination of material nonpublic information
regarding the Fund Portfolio, the Tracking Basket, and/or the Custom
Basket, as applicable, or changes thereto. Proposed BZX Rule
14.11(m)(2)(F) would require that any person or entity, including a
custodian, Reporting Authority, distributor, or administrator, who has
access to nonpublic information regarding the Fund Portfolio, the
Tracking Basket, or the Custom Basket, as applicable, or changes
thereto, must be subject to procedures designed to prevent the use and
dissemination of material nonpublic information regarding the
applicable Fund Portfolio, the Tracking Basket, or the Custom Basket,
as applicable, or changes thereto. Moreover, if any such person or
entity is registered as a broker-dealer or affiliated with a broker-
dealer, such person or entity will erect and maintain a ``fire wall''
between the person or entity and the broker-dealer with respect to
access to information concerning the composition and/or changes to such
Fund Portfolio, Tracking Basket, or Custom Basket, as applicable.

III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the Exchange Act and rules and regulations
thereunder applicable to a national securities exchange.\14\ In
particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Exchange Act,\15\ which
requires, among other things, that the Exchange's rules be 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 a national market system,
and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \14\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \15\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission previously approved BZX Rule 14.11(m) to permit the
listing and trading of Tracking Fund Shares.\16\

As discussed above, under the current rule, a series of Tracking Fund
Shares must create or redeem shares in return for the Tracking Basket
and/or cash. The Exchange is now proposing to amend BZX Rule 14.11(m)
to allow a series of Tracking Fund Shares to create or redeem shares in
return for a Custom Basket, which is a portfolio of securities that is
different from the Tracking Basket, to the extent consistent with an
issuer's exemptive relief under the 1940 Act.\17\ For the reasons
discussed below, the Commission finds that the proposed amendments to
BZX Rule 14.11(m) to provide for the use of Custom Baskets for Tracking
Fund Shares, to the extent permitted by an issuer's exemptive relief
under the 1940 Act, are consistent with Section 6(b)(5) of the Exchange
Act.
---------------------------------------------------------------------------

    \16\ See Securities Exchange Act Release No. 88887 (May 15,
2020), 85 FR 30990 (May 21, 2020) (SR-CboeBZX-2019-107) (approving
proposal to adopt Rule 14.11(m) to permit the listing and trading of
Tracking Fund Shares and to list and trade shares of the Fidelity
Blue Chip Value ETF, Fidelity Blue Chip Growth ETF, and Fidelity New
Millennium ETF (``2020 Order'')). The Exchange must file a separate
proposed rule change pursuant to Section 19(b) of the Exchange Act
for each series of Tracking Fund Shares. See BZX Rule
14.11(m)(2)(A).
    \17\ The Commission has granted exemptive relief under the 1940
Act to certain series of Tracking Fund Shares to permit the creation
or redemption of shares using a Custom Basket that includes
instruments that are not included, or included with different
weightings, in the fund's Tracking Basket. See, e.g., Fidelity Beach
Street Trust, et al., Investment Company Act Release No. 34350
(August 5, 2021).
---------------------------------------------------------------------------

    The Commission believes that the proposed changes to BZX Rules
14.11(m)(2)(E) and (F) are consistent with the Exchange Act and are
reasonably designed to help prevent fraudulent and manipulative acts
and practices. The Commission notes that, because Tracking Fund Shares
do not publicly disclose on a daily basis information about the
holdings of the Fund Portfolio, it is vital that key information
relating to Tracking Fund Shares, including information relating to
Custom Baskets, be kept confidential prior to its public disclosure and
not be subject to misuse.\18\ Accordingly, the Commission believes that
the Exchange's proposal to amend BZX Rules 14.11(m)(2)(E) and (F) \19\
to apply the current ``fire wall'' and other requirements contained
therein to those that have access to information concerning, or make
decisions pertaining to, the composition of and/or changes to the
Custom Baskets, in addition to the existing requirements relating to
the Fund Portfolio and the Tracking Basket, is designed to prevent
fraud and manipulation with respect to Tracking Fund Shares.
---------------------------------------------------------------------------

    \18\ See 2020 Order, supra note 16, 85 FR at 31002-03.
    \19\ See supra Section II, describing proposed BZX Rules
14.11(m)(2)(E) and (F).
---------------------------------------------------------------------------

    The Commission also believes that the proposed amendments to the
initial and continued listing requirements for Tracking Fund Shares are
adequate to ensure transparency of information relating to Custom
Baskets utilized by a fund and to ensure that such information is
available to the rest of the market participants at the same time.
Specifically, prior to the opening of trading on each business day, the
Investment Company will make publicly available on its website the
composition of any Custom Basket transacted on the previous business
day, except a Custom Basket that differs from the applicable Tracking
Basket only with respect to cash.\20\ In addition, prior to the initial
listing of the Tracking Fund Shares, the Exchange will be required to
obtain a representation from the issuer of each series of Tracking Fund
Shares that the issuer and any person acting on behalf of the series of
Tracking Fund Shares will comply with Regulation FD, including with
respect to any Custom Basket.\21\ These measures help to mitigate
concerns that certain information regarding the funds will be available
only to select market participants and thereby helps to prevent fraud
and manipulation.
---------------------------------------------------------------------------

    \20\ See proposed BZX Rule 14.11(m)(4)(B)(ii).
    \21\ See proposed BZX Rule 14.11(m)(4)(A)(ii)(c). The Commission
notes that a fund's use of, or conversations with authorized
participants about, Creation Baskets that would result in selective
disclosure of nonpublic information would effectively be limited by
the fund's obligation to comply with Regulation FD. See, e.g.,
Fidelity Beach Street Trust, et al., Investment Company Act Release
No. 34326 (July 9, 2021).
---------------------------------------------------------------------------

    The Commission notes that, as set forth in the definition of
``Custom Basket,'' a series of Tracking Fund Shares may only utilize
Custom Baskets to the extent consistent with the exemptive relief
issued pursuant to the 1940 Act applicable to such series.\22\ The
Commission further notes that all series of Tracking Fund Shares will
continue to be subject to the existing rules and procedures that govern
the listing and trading of Tracking Fund Shares and the trading of
equity securities on the Exchange.
---------------------------------------------------------------------------

    \22\ See proposed BZX Rule 14.11(m)(3)(F).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Exchange Act \23\ that the proposed rule change (SR-CboeBZX-2021-053),
be, and it hereby is, approved.
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78s(b)(2).
    \24\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-21483 Filed 10-1-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Rules and Regulations]
[Pages 59901-59906]
[FR Doc No: 2011-24990]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0087; FRL-8889-8]

Isaria fumosorosea Apopka Strain 97; Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Isaria fumosorosea (formerly known as
Paecilomyces fumosoroseus) Apopka strain 97 in or on all food
commodities when applied as an insecticide or miticide and used in
accordance with good agricultural practices. Certis USA, LLC, submitted
a petition to EPA under the Federal Food, Drug, and Cosmetic Act
(FFDCA) requesting an exemption from the requirement of a tolerance.
This regulation eliminates the need to establish a maximum permissible
level for residues of Isaria fumosorosea Apopka strain 97 under the
FFDCA.

DATES: This regulation is effective September 28, 2011. Objections and
requests for hearings must be received on or before November 28, 2011,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0087. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
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.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

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 Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the harmonized test guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''

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-2010-0087 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
November 28, 2011. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0087, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: OPP Regulatory Public Docket (7502P), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of March 10, 2010 (75 FR 11171) (FRL-8810-
8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 9F7665) by Certis USA, LLC, 9145 Guilford Rd., Suite 175,
Columbia, MD 21046. The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of Paecilomyces fumosoroseus (now recognized as
Isaria fumosorosea) Apopka strain 97. This notice referenced a summary
of the petition prepared by the petitioner, Certis USA, LLC, which is
available in the docket via http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
modified the nomenclature of the active ingredient, which was recently
reclassified as Isaria fumosorosea (Refs. 1, 2, and 3). The reason for
this change is explained in Unit VII.C. 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 exemption 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.
Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or
maintaining in effect an exemption from the requirement of a tolerance,
EPA must take into account the factors set forth in section
408(b)(2)(C) of FFDCA, which require EPA to give special consideration
to exposure of infants and children to the pesticide chemical residue
in establishing a tolerance 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. * * *''
Additionally, section 408(b)(2)(D) of FFDCA requires that EPA consider
``available information concerning the cumulative effects of [a
particular pesticide's] * * * residues and other substances that have a
common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information 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.

A. Overview of Isaria fumosorosea Apopka Strain 97

    In 1986, Paecilomyces fumosoroseus Apopka strain 97, an
entomopathogenic fungus, was isolated from a mealy bug in a greenhouse
in Apopka, Florida. It was recently reclassified, however, as Isaria
fumosorosea Apopka strain 97 (Refs. 1, 2, and 3). Because of this
history, in this and other EPA documents it is variously referred to as
Isaria fumosorosea Apopka strain 97, Paecilomyces fumosoroseus Apopka
strain 97, or PFR-97. The pure culture was identified in 1988 and
deposited at the American Type Culture Collection (ATCC
20874) in Manassas, Virginia. Conidia of the fungus attach to, and
penetrate, the cuticle of the host insect or mite where they germinate
and grow. This leads to pathogenesis and eventual death of the diseased
insect or mite host.
    Isaria fumosorosea Apopka strain 97 is the active ingredient in two
microbial pesticide products, which were registered under section 3 of
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) on
April 22, 1998 to Thermo Trilogy:
    1. PFR-97TM MUP (EPA Reg. No. 70051-17); and
    2. PFR-97TM 20% WDG (EPA Reg. No. 70051-19).
    Later, Thermo Trilogy changed its name to Certis USA, LLC; Certis
USA, LLC is both the petitioner and the current registrant of the
aforementioned products. Since the registration of these pesticide
products in 1998, they have been labeled specifically for non-food
applications in greenhouses and nurseries to control various insects
and mites (e.g., whiteflies, aphids, thrips and spider mites).
    After maintaining the registrations with non-food uses for 13
years, Certis USA, LLC has now petitioned EPA to establish an exemption
from the requirement of a tolerance for residues of Isaria fumosorosea
Apopka strain 97 in or on all food commodities. Accordingly, EPA has
reassessed the mammalian toxicology data that were submitted prior to
1998 to support the initial applications for Isaria fumosorosea Apopka
strain 97 pesticide products. The overall conclusions from these data,
along with Toxicity Category classifications (as appropriate), are
described in Unit III.B., while more in-depth synopses of the study
results can be found in the 2011 Isaria fumosorosea (formerly
Paecilomyces fumosoroseus) Apopka strain 97 Biopesticides Registration
Action Document (BRAD) and a 2011 data evaluation record provided as
references in Unit IX. (Refs.

3 and 4). To learn more about the Toxicity Categories, please see 40
CFR 156.62.

B. Microbial Pesticide Toxicology Data Requirements

    All mammalian toxicology data requirements supporting the request
for an exemption from the requirement of a tolerance for residues of
Isaria fumosorosea Apopka strain 97 in or on all food commodities have
been fulfilled with studies evaluated by EPA as acceptable (i.e., data
that are scientifically sound and useful for risk assessment) or
supplemental (i.e., data that provide some information useful for risk
assessment).
    1. Acute oral toxicity/pathogenicity--rat (Harmonized Guideline
885.3050; Master Record Identification Number (MRID No.) 431639-01). An
acceptable acute oral toxicity/pathogenicity study demonstrated that
Isaria fumosorosea Apopka strain 97 was not toxic, pathogenic, or
infectious to test rodents. An oral dose of 1.7 x 10\6\ colony-forming
units (cfu)/animal in a conidia spore suspension did not produce
mortality or abnormal clinical effects. No signs of fungal
contamination were reported for the brain, mesenteric lymph nodes,
blood, kidney, spleen, liver, lung or cecum, and no infectivity or
pathogenicity was recorded (Toxicity Category IV).
    2. Acute dermal toxicity--rabbit (Harmonized Guideline 885.3100;
MRID No. 432255-01). An acceptable acute dermal toxicity test
demonstrated that Isaria fumosorosea Apopka strain 97 was not toxic to
rabbits when applied dermally. Two grams of test substance applied to
the skin of rabbits produced a mild irritation at 72 hours post dosing,
but dermal irritation was completely reversed by day 7. There were no
deaths and no evidence of systemic toxicity. The acute dermal median
lethal dose (LD50) (i.e., a statistically derived single
dose that can be expected to cause death in 50% of test animals) was
greater than 2,000 milligrams per kilogram (mg/kg) (Toxicity Category
III).
    3. Acute pulmonary toxicity/pathogenicity--rat (Harmonized
Guideline 885.3150; MRID No. 431398-02). An acceptable acute pulmonary
toxicity/pathogenicity study demonstrated that Isaria fumosorosea
Apopka strain 97 was not toxic, pathogenic, or infectious when a single
dose (10\6\ conidia spores/animal) was intratrachaelly administered to
rats. No deaths, signs of toxicity or infection, or colonization of the
lungs were observed. Total clearance of the fungus was attained by day
eight after treatment (Toxicity Category IV).
    4. Acute injection toxicity/pathogenicity (intraperitoneal)--rat
(Harmonized Guideline 885.3200; MRID No. 431398-03). An acceptable
acute injection toxicity/pathogenicity study demonstrated that single
intraperitoneal doses of Isaria fumosorosea Apopka strain 97
suspensions, containing 1.6 x 10\7\ conidia spores per animal, had no
toxic or pathogenic effects. Moreover, the spores were cleared from the
body within two days (Toxicity Category IV).
    5. Acute eye irritation--rabbit (Harmonized Guideline 870.2400;
MRID No. 431462-01). An acceptable acute eye irritation study
demonstrated that Isaria fumosorosea Apopka strain 97 produced slight
eye irritation in rabbits. A dose of 0.1 milliliter of diluted test
substance, containing >=10\7\ cfu, was instilled in the eye, which was
examined 1 hour, 24 hours, 48 hours, 72 hours, 4 days, and 7 days after
treatment (irritation symptoms reversed by day 4; Toxicity Category
IV).
    6. Primary dermal irritation--rabbit (Harmonized Guideline
870.2500; MRID No. 431462-02). An acceptable primary dermal irritation
study demonstrated that Isaria fumosorosea Apopka strain 97 was
slightly irritating to the skin of rabbits (irritation symptoms
reversed by 48 hours; Toxicity Category IV).
    7. Dermal sensitization--guinea pig (Harmonized Guideline 870.2600;
MRID No. 431462-03). A supplemental dermal sensitization study
demonstrated that Isaria fumosorosea Apopka strain 97 was not a dermal
sensitizer to guinea pigs when induced and challenged at 3.0 x 10\7\ -
5.3 x 10\9\ cfu.
    8. Hypersensitivity incidents (Harmonized Guideline 885.3400). No
hypersensitivity incidents involving Isaria fumosorosea Apopka strain
97 have been reported to EPA over the last 13 years, during which time
the associated pesticide products have been both manufactured and used
for non-food uses.

IV. Aggregate Exposure

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).

A. Dietary Exposure

    Dietary exposure to this microbial pesticide may occur (more likely
through food than drinking water), but the lack of acute oral toxicity,
infectivity, and/or pathogenicity, as exhibited in a toxicology test on
rats presented in Unit III.B., supports the establishment of a
tolerance exemption for residues of Isaria fumosorosea Apopka strain 97
in or on all food commodities when used in accordance with good
agricultural practices.
    1. Food exposure. For several reasons described in this unit,
exposure to this microbial active ingredient through food is expected
to be minimal. When applied in accordance with good agricultural
practices, Isaria fumosorosea Apopka strain 97, a well-recognized
pathogen of various insects and mites, is unlikely to persist on plants
(Refs. 3 and 4). Any spores on plants due to pesticide application
would presumably decrease over time, similar to other fungal
entomopathogens and microbial pest control agents, because of
constantly fluctuating environmental factors such as rainfall,
ultraviolet radiation, and temperature (Refs. 2, 3, 4, 5, and 6). For
instance, using artificial sunlight, Fargues et al. (1997) investigated
the effects of solar radiation on Paecilomyces fumosoroseus Apopka
strain 97 conidia and found that both ultraviolet-B (280-320 nm) and
ultraviolet-A (320-400 nm) light were most detrimental to the
germinability, survival, and infectivity of the conidia (Ref. 6). In
addition to certain environmental factors, washing, peeling, and/or
other processing of food treated with Isaria fumosorosea Apopka strain
97 should further remove, dilute, and/or inactivate pesticidal residues
on food (to the extent they exist), particularly in light of the
inability of this microbe to survive in water or at temperatures higher
than 25[deg] C (Refs. 3, 4, and 5). In the remote likelihood that this
microbial pesticide is present in or on food, the acute oral toxicity
and pathogenicity data demonstrated no toxicity, infectivity, and/or
pathogenicity is likely to occur with any such exposure to Isaria
fumosorosea Apopka strain 97 (see additional discussion in Unit
III.B.).
    2. Drinking water exposure. The potential for significant transfer
of Isaria fumosorosea Apopka strain 97 to drinking water is minimal to
non-existent, specifically given the three bases elaborated upon in
this unit. First, there are no aquatic use sites permitted for
pesticide products containing Isaria fumosoroseus Apopka strain 97, so
exposure to surface water is not anticipated. Second, Isaria
fumosorosea Apopka strain 97 is not known as an aquatic microorganism;
therefore, even if Isaria fumosorosea Apopka strain 97 were to
inadvertently come into contact with surface or ground waters, it is

unlikely to proliferate in water (Refs. 3 and 4). Finally, if Isaria
fumosorosea Apopka strain 97 were to be transferred to surface water
intended for eventual human consumption (e.g., through spray drift or
runoff) and also managed to persist, it would not survive the
conditions water is subjected to in wastewater treatment systems or
drinking water facilities, including high temperatures, chlorination,
pH adjustments and/or filtration (Refs. 7 and 8). In the remote
likelihood that this microbial pesticide is present in drinking water,
the acute oral toxicity and pathogenicity data demonstrated no
toxicity, infectivity and/or pathogenicity is likely to occur with any
such exposure to Isaria fumosorosea Apopka strain 97 (see additional
discussion in Unit III.B.).

B. Other Non-Occupational Exposure

    Non-occupational dermal and inhalation exposure to Isaria
fumosorosea Apopka strain 97 is expected to be minimal to non-existent,
primarily because it will be applied to agricultural sites not in the
proximity of residential areas where facilities with sensitive
subpopulations (e.g., schools, nursing homes, and daycares) are most
often situated. Even if non-occupational dermal and inhalation exposure
were to occur inadvertently (e.g., through spray drift) or due to an
eventual expansion of use sites, such exposure would not be of concern
since testing indicates that Isaria fumosorosea Apopka strain 97 is not
toxic, pathogenic, and/or infective (acute dermal toxicity and acute
pulmonary toxicity/pathogenicity); is only slightly irritating (primary
dermal irritation); and is not a sensitizer (dermal sensitization) (see
additional discussion in Unit III.B.). In addition, this active
ingredient has been in use for approximately 13 years without reported
incidents.

V. 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 exemption, EPA
consider ``available information concerning the cumulative effects of
[a particular pesticide's] * * * residues and other substances that
have a common mechanism of toxicity.'' These considerations include the
possible cumulative effects of such residues on infants and children.
EPA has not found Isaria fumosorosea Apopka strain 97 to share a common
mechanism of toxicity to mammals with any other substances, and Isaria
fumosorosea Apopka strain 97 does not appear to produce a toxic
metabolite produced by other substances that may be of toxicological
concern to human health. For the purposes of this tolerance action,
therefore, EPA has assumed that Isaria fumosorosea Apopka strain 97
does not have a common mechanism of toxicity with other substances.
Following from this, EPA concludes that no cumulative or incremental
effects to humans, including infants and children, are anticipated in
connection with the use of Isaria fumosorosea Apopka strain 97 when it
is used in accordance with its label directions and good agricultural
practices. 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 Web site at http://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for United States (U.S.) Population,
Infants and Children

    In considering the establishment of a tolerance or tolerance
exemption for a pesticide chemical residue, FFDCA section 408(b)(2)(C)
provides that EPA shall assess the available information about
consumption patterns among infants and children, special susceptibility
of infants and children to pesticide chemical residues, and the
cumulative effects on infants and children of the residues and other
substances with a common mechanism of toxicity. In addition, FFDCA
section 408(b)(2)(C) 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 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 the acute toxicity and pathogenicity data discussed in
Unit III.B., as well as use of Isaria fumosorosea Apopka strain 97 as a
microbial pesticide for approximately 13 years without reported adverse
effects to humans, EPA concludes that there are no threshold effects of
concern to infants, children, or adults when Isaria fumosorosea Apopka
strain 97 is used as labeled in accordance with good agricultural
practices. As a result, the Agency concludes that no additional margin
of exposure (safety) is necessary to protect infants and children, and
that not adding any additional margin of exposure (safety) will be safe
for infants and children.
    Moreover, based on the same data and EPA analysis as previewed in
this unit, the Agency is able to conclude that there is a reasonable
certainty that no harm will result to the U. S. population, including
infants and children, from aggregate exposure to the residues of Isaria
fumosorosea Apopka strain 97 when it is used--as labeled and in
accordance with good agricultural practices--as an insecticide or
miticide. Such exposure includes all anticipated dietary exposures and
all other exposures for which there is reliable information. EPA has
arrived at this conclusion because, considered collectively, the data
and information available on Isaria fumosorosea Apopka strain 97 do not
demonstrate toxic, pathogenic, and/or infective potential to mammals,
including infants and children.

VII. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. In this
context, EPA considers the international maximum residue limits (MRLs)
established by the Codex Alimentarius Commission (Codex), as required
by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food
and Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for Isaria fumosorosea Apopka
strain 97.

C. Revisions to Petitioned-for Tolerance Exemption

    In the Federal Register of March 10, 2010, EPA announced Certis
USA, LLC's filing of a pesticide petition that

proposed establishing an exemption from the requirement of a tolerance
for residues of Paecilomyces fumosoroseus Apopka strain 97. Data
submitted to EPA, as well as a review of current literature,
demonstrate that the taxonomy of the microorganism has changed.
Paecilomyces fumosoroseus Apopka strain 97 is now classified as Isaria
fumosorosea Apopka strain 97 (Refs. 1, 2, and 3).

VIII. Conclusions

    EPA concludes that there is a reasonable certainty that no harm
will result to the U.S. population, including infants and children,
from aggregate exposure to residues of Isaria fumosorosea Apopka strain
97. Therefore, an exemption from the requirement of a tolerance is
established for residues of Isaria fumosorosea (formerly Paecilomyces
fumosoroseus) Apopka strain 97 in or on all food commodities when
applied as an insecticide or miticide and used in accordance with good
agricultural practices.

IX. References

1. Agricultural Research Service Collection of Entomopathogenic
Fungal (ARSEF) Cultures. January 24, 2011. Isaria, plus Paecilomyces
and Evlachovea USDA-ARS Biological Integrated Pest Management
Research, Robert W. Holley Center for Agriculture and Health. 538
Tower Road, Ithaca, New York 14853-2901.
2. Zimmermann G. 2008. The entomopathogenic fungi Isaria farinosa
(formerly Paecilomyces farinosus) and the Isaria fumosorosea species
complex (formerly Paecilomyces fumosoroseus): biology, ecology and
use in biological control. Biocontrol Science and Technology 18:865-
901.
3. U.S. EPA. 2011. Isaria fumosorosea (formerly Paecilomyces
fumosoroseus) Apopka strain 97 Draft Biopesticides Registration
Action Document (BRAD) dated August 10, 2011 (available as
``Supporting & Related Material'' within docket ID number EPA-HQ-
OPP-2010-0088 at http://www.regulations.gov).
4. U.S. EPA. 2011. Request for Exemption from the Requirement of a
Tolerance. Data evaluation record prepared by I. Barsoum, Ph.D.
(available as ``Supporting & Related Material'' within docket ID
number EPA-HQ-OPP-2010-0088 at http://www.regulations.gov).
5. U.S. EPA. 1996. Microbial Pesticide Test Guidelines--Background
for Residue Analysis of Microbial Pest Control Agents (OPPTS
885.2000). Available from http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series885.htm.
6. Fargues J, Rougier M, Goujet R, Smits N, Coustere C, Itier B.
1997. Inactivation of Conidia of Paecilomyces fumosoroseus by Near-
Ultraviolet (UVB and UVA) and Visible Radiation. Journal of
Invertebrate Pathology 69:70-78.
7. U.S. EPA. 2004. Primer for Municipal Wastewater Treatment
Systems. EPA 832-R-04-001. Available from http://www.epa.gov/npdes/pubs/primer.pdf.
8. Centers for Disease Control and Prevention. 2009. Drinking
Water--Water Treatment. Available from http://www.cdc.gov/healthywater/drinking/public/water_treatment.html.

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section
408(d) of FFDCA in response to a petition submitted to EPA. 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 final rule has been
exempted from review under Executive Order 12866, this final rule 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 final rule 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 section 408(d) of FFDCA, such as the tolerance exemption
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 final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, EPA 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, EPA 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 final rule. In addition, this final rule
does not impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require EPA consideration of voluntary consensus standards pursuant to
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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: September 20, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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. Section 180.1306 is added to subpart D to read as follows:

Sec.  180.1306  Isaria fumosorosea (formerly Paecilomyces fumosoroseus)
Apopka strain 97; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of Isaria fumosorosea (formerly Paecilomyces fumosoroseus)
Apopka strain 97 in or on all food commodities

when applied as an insecticide or miticide and used in accordance with
good agricultural practices.

[FR Doc. 2011-24990 Filed 9-27-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 12, 2007 (Volume 72, Number 176)]
[Notices]
[Page 52104-52105]
[DOCID:fr12se07-78]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD07-14-000]

Hydrokinetic Pilot Project Workshop; Supplemental Notice of
Technical Conference With Agenda and Soliciting Comments

August 31, 2007.
    On July 19th, 2007, the Federal Energy Regulatory Commission issued
a notice of a technical conference, to be led by Commissioner Philip D.
Moeller, with Commissioner Jon Wellinghoff participating, to be held on
October 2, 2007, in Portland, Oregon. This supplemental notice provides
more detailed information and establishes an agenda, which is attached.
    The conference will take place at the Bonneville Power
Administration's Auditorium, at 911 NE. 11th Ave., Portland, Oregon,
from 10 a.m. to 4 p.m. (PST). All interested persons may attend; there
is no fee. Registration is not required, but is appreciated for
planning purposes; please register at https://www.ferc.gov/whats-new/registration/hydrokinetic-10-07-form.asp.
 Following the conference

there will be a 30-day written comment period.
    The purpose of the conference will be to present Commission staff's
proposed licensing process for hydrokinetic energy pilot projects and
to seek feedback from representatives of industry, state and federal
agencies, Non-Governmental Organizations, Native American tribes, and
members of the public.
    The goal of the proposed process is to complete licensing in as few
as six months, to provide for Commission oversight and agency input,
and to allow developers to generate electricity while testing. This
process will be available for projects that are: (1) Small (5 MW or
less), (2) removable or able to shut down on relatively short notice,
(3) not located in waters with sensitive designations; and (4) for the
purpose of testing new hydro technologies or determining appropriate
sites.
    Staff envision the license having the following characteristics:
     A short license term (5 years);
     A standard license condition requiring project alteration
or shutdown in the event that monitoring reveals an unacceptable level
of environmental effect;
     The option of applying for a 30-50 year license at the end
of the license term; and
     A standard license condition requiring decommissioning and
site restoration at the time of license expiration if the option is not
exercised.
    Transcripts of the conference will be immediately available from
Ace Reporting Company<PHONE_NUMBER> or 1-800-336-6646) for a fee. They
will be available to the public on the Commission's eLibrary system
seven calendar days after FERC receives the transcript.
    All comments (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments may be filed
electronically via the Internet in lieu of paper. The Commission
strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii)
and the instructions on the Commission's Web site (http://www.ferc.gov)

under the ``e-Filing'' link.
    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free<PHONE_NUMBER>
(voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with the
required accommodations.
    Additional details regarding the agenda and the pilot project
licensing process for this conference are attached to this notice. All
conference-related materials will be made available on the Commission's
calendar located at http://www.ferc.gov/EventCalendar/EventsList.aspx.

    For more information about the conference, please contact Kristen
Murphy at<PHONE_NUMBER>

kristen.murphy@ferc.gov), or Tim Welch at<PHONE_NUMBER>
timothy.welch@ferc.gov).

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-17930 Filed 9-11-07; 8:45 am]

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