[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Pages 83565-83566]
[FR Doc No: 2023-26272]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4673-DR; Docket ID FEMA-2023-0001]

Florida; Amendment No. 15 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster for the
State of Florida (FEMA-4673-DR), dated September 29, 2022, and related
determinations.

DATES: This amendment was issued October 25, 2023.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated October 25, 2023, the President amended the cost-sharing
arrangements regarding Federal funds provided under the authority of
the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (the ``Stafford Act''), in a letter to Deanne
Criswell, Administrator, Federal Emergency Management Agency,
Department of Homeland Security, under Executive Order 12148, as
follows:

    I have determined that the damage in certain areas of the State
of Florida resulting from Hurricane Ian during the period of
September 23 to November 4, 2022, is of sufficient severity and
magnitude that special cost sharing arrangements are warranted
regarding Federal funds provided under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act'').
    Therefore, I amend my declarations of September 29, 2022,
October 4, 2022, and November 28, 2022, to authorize Federal

funds for all categories of Public Assistance at 90 percent of total
eligible costs, except assistance previously approved at 100
percent.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-26272 Filed 11-29-23; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: July 2, 2007 (Volume 72, Number 126)]
[Notices]
[Page 36084-36091]
[DOCID:fr02jy07-103]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55953; File No. SR-NYSE-2007-46]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Order Granting Accelerated Approval of a Proposed
Rule Change, as Modified by Amendment No. 1 Thereto, Relating to the
Listing and Trading of Shares of the HealthShares\TM\ Orthopedic Repair
Exchange-Traded Fund

June 25, 2007.
    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 May 21, 2007, the New York Stock Exchange LLC (``NYSE'' or
``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 substantially by NYSE. On May
31, 2007, NYSE filed Amendment No. 1 to the proposed rule change. This
order provides notice of the proposed rule change, as amended, and
approves the proposed rule change on an accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 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 list and trade shares of the
HealthShares\TM\ Orthopedic Repair Exchange-Traded Fund (the
``Fund'').\3\ The text of the proposal is available at NYSE, the
Commission's Public Reference Room, and http://www.nyse.com.

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    \3\ The Fund is registered under the Investment Company Act of
1940 (the ``1940 Act'').
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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, and the most significant aspects of such statements are
set forth in Sections A, B, and C below.

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

1. Purpose
    The Exchange proposes to list and trade the shares of the Fund (the
``Shares''), which are Investment Company Units, as such term is
defined in Section 703.16 of the NYSE Listed Company Manual.\4\ The
Fund can invest in both U.S. securities and non-U.S. securities not
listed on a national securities exchange.\5\ Although Section 703.16 of
the NYSE Listed Company Manual permits the Exchange to either
originally list and trade Investment Company Units or trade Investment
Company Units pursuant to unlisted trading privileges,\6\ the Fund
Shares do not meet the ``generic'' listing requirements of Section
703.16 of the NYSE Listed Company Manual (permitting listing in
reliance upon Rule 19b-4(e) \7\ under the Act) because the Index (as
defined herein) underlying the Fund does not meet the initial listing
requirements of Section 703.16(C)(2)(b)(ii) of the Listed Company
Manual.\8\ Therefore, NYSE has filed the instant proposed rule change
to obtain Commission approval to list and trade the Shares on the
Exchange pursuant to Section 19(b)(2) of the Act \9\ and Rule 19b-4
thereunder.\10\
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    \4\ Section 703.16 of the NYSE Listed Company Manual defines an
Investment Company Unit as a security that represents an interest in
a registered investment company that could be organized as a unit
investment trust, an open-end management investment company, or a
similar entity.
    \5\ The Exchange represents that, as of May 7, 2007, all stocks
underlying the Index (as defined herein) were listed on a national
securities exchange (NYSE or The Nasdaq Stock Market LLC); however,
as noted above, any changes to the Index may include non-U.S. stocks
not listed on a national securities exchange.
    \6\ See Securities Exchange Act Release Nos. 55113 (January 17,
2007), 72 FR 3179 (January 24, 2007) (SR-NYSE-2006-101) (approving
amendments to generic listing standards for series of Investment
Company Units that are based on international or global indexes, or
on indexes described in rules previously approved by the
Commission); 43679 (December 5, 2000), 65 FR 77949 (December 13,
2000) (SR-NYSE-00-46) (approving generic listing standards to permit
the listing and trading of Investment Company Units under Rule 19b-
4(e) under the Act); and 36923 (March 5, 1996), 61 FR 10410 (March
13, 1996) (SR-NYSE-95-23) (approving the original listing standards
for units of trading that represent interests in a registered
investment company that would be organized either as an open-end
management investment company or as a unit investment trust).
    \7\ 17 CFR 240.19b-4(e).
    \8\ Section 703.16(C)(2)(b)(ii) of the NYSE Listed Company
Manual requires that, upon the initial listing of any series of
Investment Company Units, the component stocks that in the aggregate
account for at least 90% of the weight of the index or portfolio
each must have minimum worldwide trading volume during each of the
last six months of at least 250,000 shares. The Exchange represents
that Index component stocks each having a worldwide monthly trading
volume of at least 250,000 shares in the aggregate account for
approximately 86.2% of the weight of the Index during each month
from November 2006 through April 2007. Because such percentage
misses the minimum required threshold by approximately 3.8%, the
Shares cannot be listed and traded pursuant to Section 703.16 of the
NYSE Listed Company Manual. The Exchange represents that the Fund
Shares otherwise meet all of the other ``generic'' listing standards
under Section 703.16 of the NYSE Listed Company Manual. Telephone
conversation between Michael Cavalier, Assistant General Counsel,
NYSE, and Edward Cho, Special Counsel, Division of Market Regulation
(``Division''), Commission, on June 21, 2007 (``June 21
Confirmation'').
    \9\ 15 U.S.C. 78s(b)(1).
    \10\ 17 CFR 240.19b-4.
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    The Fund will be based on the HealthSharesTM Orthopedic
Repair Index (``Underlying Index'' or ``Index'').\11\ XShares Advisors,
LLC is the investment adviser (the ``Advisor'') to the Fund.\12\ BNY
Investment Advisors (the ``Sub-Advisor'') acts as the investment sub-
advisor to the Fund. The Sub-Advisor is registered under the Advisers
Act and is responsible for the day-to day management of the Fund's
portfolio, which involves principally reconfiguring the portfolio of
the Fund, typically quarterly, to reflect any reconfiguration in the
Underlying Index for the Fund by the Index Administrator (as defined
herein). While the Fund is managed by the Advisor or Sub-Advisor, the
Corporation's Board of Directors has overall responsibility for the
Fund's operations. Standard and Poor's, a division of The McGraw Hill
Companies, Inc., is the index administrator (the ``Index
Administrator'') for the Index. The Index Administrator is responsible
for maintaining the Index as described below.\13\ ALPS Distributors,
Inc. is a registered broker-dealer and acts as distributor and
underwriter (the ``Distributor'') of the Creation Units (as defined
herein) of the Shares.\14\ The Distributor distributes the Shares on an
agency basis.
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    \11\ HealthShares\TM\, Inc. (the ``Corporation'') is an open-end
management company with twenty other series of underlying fund
portfolios that offer shares known as HealthShares\TM\ which are
similar to the Shares and are currently listed and trading on the
Exchange.
    \12\ The Advisor is registered as an ``investment adviser''
under Section 203 of the Investment Advisers Act of 1940 (the
``Advisers Act''). See 15 U.S.C. 80b-3.
    \13\ S&P is neither a registered broker-dealer nor an
``affiliated person,'' as defined in Section 2(a)(3) of the 1940
Act, or an affiliated person of an affiliated person of the Fund,
Advisor, Sub-Advisor, Distributor (as defined herein), or the
Corporation. See 15 U.S.C. 80a-2(a)(3).
    \14\ The Exchange represents that the Distributor is not an
``affiliated person'' of the Advisor, the Sub-Advisor, the Fund, or
the Corporation.
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    Description of the Underlying Index and the Fund. The Exchange
states that the Underlying Index uses a patent-pending investment
approach known as ``Vertical Investing.'' Vertical Investing seeks to
categorize companies within a particular healthcare, life sciences, or
biotechnology index by focusing on each company's business activities
with regard to the diagnosis of diseases, the developments of drugs,
treatments, therapies, delivery systems, and the development of
enabling/research tools and technologies for use in the healthcare,
life sciences, or biotechnology sectors. The Underlying Index for the
Fund has been designed around verticals in the area of orthopedic
repair.
    Based on its own proprietary intellectual model, the Index uses
established specific, defined characterization/inclusion/exclusion
criteria (the ``Index Methodology'') that an issuer must meet in order
to be included in the Underlying Index. The Index Administrator employs
the Index Methodology to determine the composition of the Underlying
Index. When determining the composition of the Underlying Index, the
Index Administrator relies on many sources of information, including
information obtained from the BioCentury and MedTrack databases. The
BioCentury and MedTrack databases are independent, generally available
databases that provide a vast amount of data for healthcare, life
sciences, and biotechnology companies, including information regarding
products, clinical trials, pipeline development, patent, and other
information. The Index Methodology is publicly available on the Fund's
Web site at http://www.healthsharesinc.com. Any change to the Index

Methodology will be posted on the Fund's Web site at least 60 days
prior to implementation of such change. For the equity components
underlying the Index, the market capitalization range is generally from
$100 million to $20 billion. Typically, the largest of these companies
(determined by market capitalization) are included in the Index, with a
minimum of 22 companies in the Index.\15\ The initial companies

selected for inclusion are weighted equally at inception and are
thereafter weighted based upon the individual company's market value
relative to the overall market value of the Index (i.e., price
weighted). Maximum weighting for any security in the Index is typically
15%. When a company's weighting exceeds 15% of the Index, the Index
Administrator will reduce such company's weighting to 10%, with the 5%
``excess'' applied equally to all remaining component securities in the
Underlying Index. Minimum weighting for a security in the Index is
2.5%. If a security's weighting falls below 2.5%, the Index
Administrator will increase the security's weighting to its initial
weighting or 5%, whichever is less, with the required increment taken
equally from all the remaining component securities. Information about
the Index, including the component securities in the Index and value of
the securities in the Index are posted throughout the trading day at
least every 15 seconds and are available through Reuters, a market data
vendor.
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    \15\ The Exchange states that, as of May 7, 2007, the Index had
a total market capitalization of approximately $52.2 billion. The
average total market capitalization was approximately $2.4 billion.
The Index's top three holdings were Zimmer Holdings, Smith & Nephew
PLC (ADR), and DENTSPLY International. The ten largest constituents
by market capitalization represented approximately 52.2% of the
Index weight. The five highest weighted stocks, which represented
34.1% of the Index weight, had an average daily trading volume in
excess of 7.3 million shares during the period November 2006 through
April 2007. 86.2% of the Index had worldwide monthly trading volume
of 250,000 shares during each of the last 6 months (November 2006
through April 2007). The average monthly trading volume for the
Index stocks over the last 6 months was 145.5 million shares.
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    The Fund's overall investment objective is to track the
performance, before fees and expenses, of the Index. The Adviser uses a
passive, or indexing, approach in managing the Fund. The Fund will
invest at least 90% of its assets in the common stocks of companies in
the Index, or in American Depositary Receipts (``ADRs'') or Global
Depositary Receipts (``GDRs'') based on securities of international
companies in the Index. Because the Index is comprised only of stocks
as indicated by its name (i.e., only companies associated with the
orthopedic repair business are contained in the Index), the Fund will
invest at least 90% of its assets in such companies. The Fund will
provide shareholders with at least 60 days' notice of any change in
these policies. The Fund may also invest up to 10% of its assets in
futures contracts, options on futures contracts, options, swaps on
securities of companies in the Index, as well as cash and cash
equivalents, such as money market instruments (subject to applicable
limitations of the 1940 Act). The Fund will attempt to replicate the
Index by matching the weighting of securities in its portfolio with
such securities' weightings in the Index. In managing the Fund, the
Advisor seeks a correlation of 0.95 or better between the Fund's
performance and the performance of its Underlying Index. A figure of
1.00 would mean perfect correlation.
    From time to time, it may not be possible, for regulatory or other
legal reasons, to replicate the Index, and in such cases, the Advisor
may pursue a sampling strategy in managing the portfolio. Pursuant to
this strategy, the Fund may invest the remainder of its assets in
securities of companies not included in the Index if the Advisor
believes that such securities will assist the Fund in tracking the
Index. If the Fund pursues a sampling strategy, it will continue to
invest at least 90% of its assets in the common stocks, ADRs, or GDRs
of the companies in the Index.
    Transaction expenses, including operational processing and
brokerage costs, will be incurred by the Fund when investors purchase
or redeem Creation Units ``in-kind'' and such costs have the potential
to dilute the interests of the Fund's existing shareholders. Hence, the
Fund will impose purchase or redemption transaction fees (``Transaction
Fees'') in connection with effecting such purchases or redemptions. The
exact amounts of such Transaction Fees will be determined separately
for the Fund and described in the Fund's Prospectus.
    Creations and Redemptions. The Fund will continuously issue its
Shares in one or more groups of a fixed number of Shares (i.e., 100,000
Shares). Each such group of Shares is called a ``Creation Unit,'' and
such fixed number will be set forth in the Prospectus for the Fund. The
initial price per Share of the Fund is expected to be approximately
$25. Accordingly, the initial price of a Creation Unit would be
approximately $2,500,000.\16\
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    \16\ June 21 Confirmation.
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    All orders to purchase Shares in Creation Units must be placed with
the Distributor by or through a ``Participating Organization'' which
has entered into a participant agreement with the Distributor and is
either (1) a ``Participating Party,'' i.e., a broker-dealer or other
participant in the Continuous Net Settlement System of the National
Securities Clearing Corporation (the ``Clearing Process''), a clearing
agency registered with the Commission, or (2) a participant in the
Depository Trust Company (``DTC''). A Participating Organization is not
required to be a member of an exchange.
    Payment with respect to Creation Units placed through the
Distributor will be made by the purchasers generally by an ``in-kind''
deposit with the Corporation of a basket of stocks that are part of the
Fund's Underlying Index (``Deposit Securities'') together with an
amount of cash specified by the Advisor or the Sub-Advisor in the
manner described below (the ``Balancing Amount'').\17\ The deposit of
the requisite Deposit Securities, the Balancing Amount, and any
Transaction Fees are collectively referred to herein as a ``Portfolio
Deposit.''
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    \17\ The Balancing Amount is an amount equal to the difference
between (1) the net asset value (``NAV'') per Creation Unit of the
Fund and (2) the total aggregate market value per Creation Unit of
the Deposit Securities (such value referred to herein as the
``Deposit Amount''). With respect to purchases of Creation Units,
the Balancing Amount serves the function of compensating for
differences, if any, between the NAV per Creation Unit and the
Deposit Amount.
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    The Advisor will make available on each business day at http://www.healthsharesinc.com
,\18\ prior to the opening of trading on the

Exchange, the list of the names and the required number of shares of
each Deposit Security included in the current Portfolio Deposit (based
on information at the end of the previous business day) for the Fund
(the ``Creation List''). Such Portfolio Deposit will be applicable,
subject to any adjustments to the Balancing Amount, as described below,
in order to effect purchases of Creation Units of the Fund until such
time as the next-announced Portfolio Deposit composition is made
available. The Advisor also will make available on each business day,
prior to the opening of trading on the Exchange, the list of securities
in the Fund's portfolio holdings that an investor who tenders a
Creation Unit will receive as redemption proceeds (``Redemption
Securities''). This list is referred to as the ``Redemption List,'' as
discussed below. The Creation List, Redemption List, Balancing Amount,
and the Cash Redemption Payment (as defined herein), each as created by
the Sub-Advisor, also are made available to Participating Parties upon
request through the facilities of the Clearing Process.
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    \18\ Telephone conversation between Michael Cavalier, Assistant
General Counsel, NYSE, and Edward Cho, Special Counsel, Division,
Commission, on May 30, 2007.
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    The identity and number of shares of the Deposit Securities
required for the Portfolio Deposit for the Fund will change as re-
balancing adjustments and corporate action events are reflected from
time to time by the Advisor or the Sub-Advisor with a view to the
investment objective of the Fund. The composition of the Deposit
Securities may also change in response to adjustments to the weighting
or composition of the component

securities in the Index. The adjustments described above also will
reflect changes in the composition of the Index resulting from stock
splits and other corporate actions.
    In addition, the Corporation reserves the right with respect to the
Fund to permit or require the substitution of an amount of cash (i.e.,
a ``cash in lieu'' amount) to be added to the Balancing Amount to
replace any Deposit Security which: (1) May be unavailable or not
available in sufficient quantity for delivery to the Corporation upon
the purchase of Shares in Creation Units; (2) may not be eligible for
transfer through the Clearing Process; or (3) may not be eligible for
trading by a Participating Organization or the investor on whose behalf
the Participating Organization is acting. When such cash purchases of
Creation Units are available or specified for the Fund, such purchases
would occur in essentially the same manner as ``in-kind'' purchases of
the Shares. In the case of a cash purchase, the investor must pay the
cash equivalent of the Deposit Securities it would otherwise be
required to provide through an ``in-kind'' purchase, plus the same
Balancing Amount required to be paid by an ``in-kind'' purchaser. In
addition, trading costs, operational processing costs, and brokerage
commissions associated with using cash to purchase the requisite
Deposit Securities will be incurred by the Fund and will affect the
value of all Shares. Hence the Advisor, subject to the approval of the
Board of Directors of the Corporation, may adjust the relevant
Transaction Fee to defray any such costs and prevent shareholder
dilution within specified parameters.
    The Participating Organization must make available on or before the
contractual settlement date by means satisfactory to the Corporation
immediately-available or same-day funds estimated by the Corporation to
be sufficient to pay the Balancing Amount next determined after
acceptance of the purchase order, together with the applicable
Transaction Fee. Any excess funds would be returned following
settlement of the Creation Unit purchase.
    Once the Corporation has accepted an order, upon the next
determination of the NAV per Share of the Fund, the Corporation will
confirm the issuance, against receipt of payment, of a Creation Unit of
the Fund at such NAV. The Distributor would then transmit a
confirmation of acceptance to the Participating Organization that
placed the order. A Creation Unit would not be issued until the
transfer of good title to the Corporation of the Deposit Securities and
the payment of the Balancing Amount have been completed (subject to
certain exceptions).
    Beneficial owners may sell their Shares in the secondary market,
but must accumulate enough Shares to constitute a Creation Unit in
order to redeem through a Participating Organization. Redemption orders
must be placed by or through a Participating Organization. Creation
Units will be redeemable at their NAV per Share next determined after
receipt of a request for redemption by the Corporation. The Corporation
has the right to make redemption payments in respect of the Fund in
cash, ``in-kind,'' or a combination of both, provided the value of its
redemption payments on a Creation Unit basis equals the NAV, times the
appropriate number of Shares of the Fund. The Corporation currently
contemplates that Creation Units of the Fund will be redeemed
principally ``in-kind'' (together with a balancing cash payment),
except in certain circumstances.
    In some instances, the Creation List may differ slightly from the
Redemption List. The Corporation will also deliver to the redeeming
Beneficial Owner in cash the ``Cash Redemption Payment,'' which on any
given business day will be an amount calculated in the same manner as
that for the Balancing Amount, although the actual amounts may differ
if the Redemption List is not identical to the Creation List applicable
for purchases on the same day. To the extent that the Redemption
Securities on the Redemption List have a value greater than the NAV of
the Shares being redeemed, a cash payment equal to the difference is
required to be paid by the redeeming party to the Corporation. The
Corporation may also make redemptions in cash in lieu of transferring
one or more Redemption Securities to a redeemer if the Corporation
determines, in its discretion, that such method is warranted. This
could occur, for example, when a redeeming entity is restrained by
regulation or policy from transacting in certain Redemption Securities,
such as the presence of such Redemption Securities on a redeeming
investment banking firm's restricted list.
    Redemption of Shares in Creation Units will be subject to a
Transaction Fee imposed in the same amount and manner as the
Transaction Fee incurred in purchasing such Shares. Redemption of
Shares may be made either through the Clearing Process or through the
facilities of DTC.
    Dividends and Distributions. Dividends from net investment income
will be declared and paid at least annually by the Fund in the same
manner as by other open-end investment companies. Dividends will be
paid to beneficial owners of record in the manner described below.
Distributions of realized capital gains, if any, generally will be
declared and paid once a year, but the Fund may make distributions on a
more frequent basis to comply with certain distribution requirements.
    Dividends and other distributions on the Shares will be distributed
on a pro rata basis to beneficial owners of such Shares. Dividend
payments will be made through the DTC and the DTC Participants to
beneficial owners on the record date with amounts received from the
Fund.\19\
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    \19\ The Exchange states that the Corporation will not make the
DTC book-entry dividend reinvestment service available for use by
beneficial owners for reinvestment of their cash proceeds, but
certain individual brokers may make a dividend reinvestment service
available to their clients. The Corporation's disclosure documents
will inform investors of this fact and direct interested investors
to contact their brokers to ascertain the availability and a
description of such a service through such brokers.
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    Shareholder Reports. The Corporation will furnish to the DTC
participants for distribution to beneficial owners of Shares of the
Fund notifications with respect to each distribution, as well as an
annual notification as to the tax status of the Fund's distributions.
The Corporation will also furnish to the DTC participants for
distribution to beneficial owners of the Shares the Corporation's
annual report containing audited financial statements, as well as
copies of annual and semi-annual shareholder reports. [FEDREG][VOL]*[/
VOL][NO]*[/NO][DATE]*[/DATE][NOTICES] [NOTICE][PREAMB][AGENCY]*[/
AGENCY][SUBJECT]*[/SUBJECT] ?>
    Availability of Information Regarding the Shares and Underlying
Index. The Exchange, through the facilities of the Consolidated Tape
Association or a major market data vendor, will disseminate at least
every 15 seconds during Exchange trading hours an amount per Share
representing the sum of (1) the estimated Balancing Amount and (2) the
current value of the Deposit Securities, on a per-Share basis. This
amount is referred to herein as the Intraday Indicative Value
(``IIV''). In addition, the value of the Underlying Index will be
updated intra-day on a real-time basis as individual component
securities change in price and will be disseminated at least every 15
seconds during Exchange trading hours by one or more major market data
vendors. The value for the Underlying Index also will be disseminated
by one or more major market data vendors once each trading day based on
closing prices in the relevant exchange market.
    If the Index includes non-U.S. stocks not listed on a national
securities

exchange, there may be an overlap in trading hours between the foreign
and U.S. markets with respect to the Fund. In such a case, the
applicable IIV would be updated at least every 15 seconds to reflect
price changes in the applicable foreign market or markets, with such
prices converted into U.S. dollars based on the currency exchange rate.
When the foreign market or markets are closed and U.S. markets are
open, the IIV would be updated at least every 15 seconds to reflect
changes in currency exchange rates after the foreign market closes. The
IIV will also include the applicable cash component for the Fund.
    The NAV for the Fund will be calculated by BNY Asset Management
between 4:30 p.m. and 6:30 p.m. Eastern Time (``ET'') each trading day,
and, once calculated, BNY Asset Management and the Fund will
disseminate the NAV so that it is available to all market participants
at the same time.\20\ The updated NAV will be available on the
Corporation's Web site at the same time that the NAV is made available
to other market participants. The Corporation's Web site will also
include: (1) The Fund's Prospectus and Statement of Additional
Information; (2) information regarding the Index; (3) the prior
business day's NAV; (4) the mid-point of the bid-ask spread at the time
of calculation of the NAV (the ``Bid-Ask Price''); \21\ (5) a
calculation of the premium or discount to the Bid-Ask Price at the time
of calculation of the NAV against such NAV; (6) the component
securities of the Index; and (7) a description of the methodology used
in the foregoing computations (including weighting and number of Shares
held).
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    \20\ The Exchange represents that if the NAV is not disseminated
to all market participants at the same time, the Exchange will halt
trading in the Fund Shares.
    \21\ The Bid-Ask Price of the Fund is determined using the
highest bid and the lowest offer on the Exchange on which the Shares
are listed for trading.
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    The Exchange states that the closing prices of the Fund's Deposit
Securities are readily available from, as applicable, the relevant
exchange, automated quotation systems, and published or other public
sources or on-line information services that are major market data
vendors, such as Quotron, Bloomberg, or Reuters. Similarly, information
regarding market, prices, and volume of the Shares will be broadly
available on a real-time basis throughout the trading day. The previous
day's closing price and volume information for the Shares will be
published daily in the financial sections of many newspapers.
    Trading Rules and Criteria for Initial and Continued Listing. The
Fund Shares will trade as equity securities and will therefore be
subject to the Exchange rules governing the trading of equity
securities.\22\ The Shares will trade on the Exchange from 9:30 a.m.
until 4:15 p.m. ET. The minimum price variation for quoting will be
$.01.
---------------------------------------------------------------------------

    \22\ E-mail from Michael Cavalier, Assistant General Counsel,
NYSE, to Edward Cho, Special Counsel, Division, Commission, dated
June 4, 2007 (confirming the Exchange rules that would govern the
trading of the Shares).
---------------------------------------------------------------------------

    Although the Fund does not meet the initial listing requirements of
Section 703.16(C)(2)(b) of the NYSE Listed Company Manual, the Exchange
represents that the Fund will be subject to the criteria for continued
listing of Investment Company Units under Section 703.16(H) of the NYSE
Listed Company Manual.\23\ A minimum of one Creation Unit (100,000
shares) will be required to be outstanding at the start of trading.
This minimum number of Shares of the Fund required to be outstanding at
the start of trading will be comparable to requirements that have been
applied to previously traded series of Investment Company Units.
---------------------------------------------------------------------------

    \23\ June 21 Confirmation.
---------------------------------------------------------------------------

    Information Memo. The Exchange will distribute an Information Memo
(``Memo'') to its members in connection with the trading of the Shares
of the Fund. The Memo will discuss the special characteristics and
risks of trading this type of security. In addition, the Memo, among
other things, will discuss what the Fund is, how the Fund's shares are
created and redeemed, the requirement that members and member firms
deliver a prospectus or product description to investors purchasing
shares of the Fund prior to or concurrently with the confirmation of a
transaction (referring members and member organizations to NYSE Rule
1100(b)),\24\ the applicable Exchange rules, dissemination information,
trading information, and the applicable suitability rules (including
NYSE Rule 405).\25\ The Memo will also discuss exemptive, no-action,
and interpretive relief granted by the Commission from Section 11(d)(1)
and certain other rules under the Act, if applicable.
---------------------------------------------------------------------------

    \24\ The Exchange states that the Commission has granted the
Corporation an exemption from certain prospectus delivery
requirements under Section 24(d) of the 1940 Act. See Investment
Company Act of 1940 Release No. 27594 (December 7, 2006), 2006 SEC
LEXIS 2920 (December 15, 2006) (812-13264) (``Exemptive Order'').
The Exchange further states that any product description used in
reliance on the Exemptive Order would comply with all
representations made therein and all conditions thereto. The Memo
will advise members and member organizations that delivery of a
prospectus to customers in lieu of a product description would
satisfy the requirements of NYSE Rule 1100(b), which sets forth
certain product description delivery requirements that apply only to
a series of Investment Company Units as to which the sponsor or
other appropriate party has obtained an exemption from Section 24(d)
of the 1940 Act.
    \25\ Specifically, the Memo to members will note that, before an
Exchange member, member organization, or employee thereof recommends
a transaction in Fund Shares, a determination must be made that the
recommendation is in compliance with all applicable Exchange and
Federal rules and regulations, including due diligence obligations
under NYSE Rule 405 (Diligence as to Accounts).
---------------------------------------------------------------------------

    Trading Halts. In order to halt the trading of the Shares, the
Exchange may consider, among other things, factors such as the extent
to which trading is not occurring in an underlying security(ies) and
whether other unusual conditions or circumstances detrimental to the
maintenance of a fair and orderly market are present. In addition,
trading in the Fund's Shares is subject to trading halts caused by
extraordinary market volatility pursuant to NYSE Rule 80B. The Exchange
also may halt trading in the Fund if the Index Value or IIV applicable
to the Fund is no longer calculated or disseminated, as provided by
NYSE Rule 1100(f)(1).\26\
---------------------------------------------------------------------------

    \26\ NYSE Rule 1100(f)(1) states, in relevant part, that if the
estimate, updated at least every 15 seconds, of the IIV or the Index
value applicable to a series of Investment Company Units is not
being disseminated as required, the Exchange may halt trading during
the day in which the interruption to the dissemination of the IIV or
the Index value occurs. If the interruption to the dissemination of
the IIV or the Index value persists past the trading day in which it
occurred, the Exchange will halt trading no later than the beginning
of the trading day following the interruption. See also Section
703.16(H) of the NYSE Listed Company Manual (setting forth
additional circumstances that could trigger the suspension of
trading and delisting of the Shares).
---------------------------------------------------------------------------

    Surveillance. The Exchange will utilize its existing surveillance
procedures applicable to equity securities to monitor trading of the
Shares of the Fund. Surveillance procedures applicable to trading of
the Shares are comparable to those applicable to other Investment
Company Units currently trading on the Exchange. The Exchange
represents that such surveillance procedures are adequate to properly
monitor the trading of the Fund Shares. The Exchange's current trading
surveillance focuses on detecting securities trading outside their
normal patterns. When such situations are detected, surveillance
analysis follows, and investigations are opened, where appropriate, to
review the behavior of all relevant parties for all relevant trading
violations. The Exchange may also obtain trading information via the
Intermarket Surveillance Group (``ISG'') from other exchanges who are
members or affiliate members of ISG.

2. Statutory Basis
    The proposed rule change is consistent with Section 6 of the
Act,\27\ in general, and furthers the objectives of Section
6(b)(5),\28\ in particular, in that it is 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.
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78f.
    \28\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    The Exchange has neither solicited for nor received any written
comments on the proposed rule change.

III. 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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NYSE-2007-46 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2007-46. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the 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 inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2007-46 and should be
submitted on or before July 23, 2007.

IV. Commission's Findings and Order Granting Accelerated Approval of
the Proposed Rule Change

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\29\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\30\ which
requires that the rules of an exchange be designed, among other things,
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. Although Section 703.16 of the NYSE Listed Company
Manual permits the Exchange to either originally list and trade
Investment Company Units or trade Investment Company Units pursuant to
unlisted trading privileges, the Shares do not meet the ``generic''
listing requirements of Section 703.16 of the NYSE Listed Company
Manual (permitting listing in reliance upon Rule 19b-4(e) \31\ under
the Act) because the components of the Index underlying the Fund do not
meet the initial listing requirements of Section 703.16(C)(2)(b)(ii) of
the Listed Company Manual. Section 703.16(C)(2)(b)(ii) of the NYSE
Listed Company Manual requires that, upon the initial listing of any
series of Investment Company Units, the component stocks that in the
aggregate account for at least 90% of the weight of the index or
portfolio each must have minimum worldwide trading volume during each
of the last six months of at least 250,000 shares. The Exchange
represents that Index component stocks each having a worldwide monthly
trading volume of at least 250,000 shares in the aggregate account for
approximately 86.2% of the weight of the Index in the aggregate during
each month from November 2006 through April 2007. Because such
percentage misses the minimum required threshold by approximately 3.8%,
the Shares cannot be listed and traded pursuant to Section 703.16 of
the NYSE Listed Company Manual. The Commission believes, however, that
the listing and trading of the Shares would be consistent with the Act.
The Commission notes that it has previously approved exchange rules
that contemplate the listing and trading of derivative securities
products based on indices that were composed of stocks that did not
meet certain quantitative generic listing criteria by only a slight
margin.\32\ The Commission also notes that the Fund is substantially
similar in structure and operation to other HealthSharesTM
exchange-traded funds, the shares of which are currently listed and
trading on the Exchange.\33\
---------------------------------------------------------------------------

    \29\ In approving this 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).
    \30\ 15 U.S.C. 78f(b)(5).
    \31\ 17 CFR 240.19b-4(e).
    \32\ See Securities Exchange Act Release Nos. 55699 (May 3,
2007), 72 FR 26435 (May 9, 2007) (SR-NYSEArca-2007-27) (approving
the listing and trading of shares of the iShares FTSE NAREIT
Residential Index Fund where the weighting of the five highest
components of the underlying index was marginally higher than that
allowed by NYSE Arca, Inc.'s relevant generic listing standards);
and 52826 (November 22, 2005), 70 FR 71874 (November 30, 2005) (SR-
NYSEArca-2005-67) (approving the listing and trading of shares of
the iShares Dow Jones U.S. Energy Sector Index Fund and the iShares
Dow Jones U.S. Telecommunications Sector Index Fund where the
weightings of the most heavily weighted component stock and the five
highest components of the underlying indexes, respectively, were
higher than that required by NYSE Arca, Inc.'s relevant generic
listing standards). See also Securities Exchange Act Release No.
46306 (August 2, 2002), 67 FR 51916 (August 9, 2002) (SR-NYSE-2002-
28) (approving the trading pursuant to unlisted trading privileges
of shares of Vanguard Total Stock Market VIPERs, iShares Russell
2000 Index Funds, iShares Russell 2000 Value Index Funds, and
iShares Russell 2000 Growth Funds, none of which met the trading
volume requirement of the relevant generic listing criteria for
NYSE).
    \33\ Telephone conversation between Michael Cavalier, Assistant
General Counsel, NYSE, and Edward Cho, Special Counsel, Division,
Commission, on June 4, 2007 (confirming that the shares of other
HealthSharesTM exchange-traded funds were listed pursuant
to Rule 19b-4(e) under the Act because they met the ``generic''
listing standards under Section 703.16 of the NYSE Listed Company
Manual). See 17 CFR 240.19b-4(e).

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

    The Commission further believes that the proposal is consistent
with Section 11A(a)(1)(C)(iii) of the Act,\34\ which sets forth
Congress' finding that it is in the public interest and appropriate for
the protection of investors and the maintenance of fair and orderly
markets to assure the availability to brokers, dealers, and investors
of information with respect to quotations for and transactions in
securities. The Exchange, through the facilities of the Consolidated
Tape Association or a major market data vendor, will disseminate the
IIV at least every 15 seconds during Exchange trading hours. In
addition, one or more major market data vendors will calculate and
disseminate an updated, intra-day value of the Underlying Index on a
real-time basis during Exchange trading hours and the closing value of
such Underlying Index once each trading day. BNY Asset Management will
calculate and disseminate once each trading day the NAV to all market
participants at the same time. The Corporation's Web site at http://www.healthsharesinc.com
 will include information pertaining to the

Index and its component securities, the Index Methodology, the NAV and
the prior day's NAV, the Bid-Ask Price and related information, the
Prospectus and Statement of Additional Information, and other relevant
trading information. The Advisor will make available on each business
day, prior to the opening of trading on the Exchange, the Creation List
and Redemption List. Moreover, the closing prices of the Fund's Deposit
Securities are readily available from the relevant exchange, automated
quotation systems, and major market data vendors. Information regarding
the market, closing prices, and trading volume of the Shares will be
publicly available on a real-time basis throughout the trading day and
in the daily publications of financial news services. In sum, the
Commission believes that the proposal is reasonably designed to
facilitate access to information that could assist investors in
properly valuing the Shares.
---------------------------------------------------------------------------

    \34\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
---------------------------------------------------------------------------

    The Commission finds that the Exchange's proposed rules and
procedures for trading of the Shares are consistent with the Act. The
Shares will trade as equity securities, thus rendering trading in the
Shares subject to the Exchange's existing rules governing the trading
of equity securities.
    In support of this proposal, the Exchange has made the following
representations:
    (1) The Exchange would utilize its existing surveillance procedures
applicable to equity securities to monitor trading of the Shares of the
Fund. Surveillance procedures applicable to trading of the Shares are
comparable to those applicable to other Investment Company Units
currently trading on the Exchange. The Exchange represents that such
surveillance procedures are adequate to properly monitor the trading of
the Fund Shares. The Exchange's current trading surveillance focuses on
detecting securities trading outside their normal patterns. When such
situations are detected, surveillance analysis follows, and
investigations are opened, where appropriate, to review the behavior of
all relevant parties for all relevant trading violations. The Exchange
may also obtain trading information via the ISG from other exchanges
who are members or affiliate members of ISG.
    (2) The Index Administrator is neither a registered broker-dealer
nor an ``affiliated person,'' as defined in Section 2(a)(3) of the 1940
Act, or an affiliated person of an affiliated person of the Fund,
Advisor, Sub-Advisor, Distributor, or the Corporation.
    (3) In order to halt the trading of the Shares, the Exchange may
consider, among other things, factors such as the extent to which
trading is not occurring in an underlying security and whether other
unusual conditions or circumstances detrimental to the maintenance of a
fair and orderly market are present. In addition, trading in the Fund's
shares is subject to trading halts caused by extraordinary market
volatility pursuant to NYSE Rule 80B. The Exchange also may halt
trading in the Fund if the Index Value or IIV applicable to the Fund is
no longer calculated or disseminated, as provided by NYSE Rule
1100(f)(1).\35\
---------------------------------------------------------------------------

    \35\ See supra note 26.
---------------------------------------------------------------------------

    (4) The Exchange will distribute a Memo to its members in
connection with the trading of the Shares of the Fund. The Memo will
discuss the special characteristics and risks of trading this type of
security. In addition, the Memo, among other things, will discuss what
the Fund is, how the Fund's shares are created and redeemed, the
requirement that members and member firms deliver a prospectus or
product description to investors purchasing shares of the Fund prior to
or concurrently with the confirmation of a transaction,\36\ the
applicable Exchange rules, dissemination information, trading
information, and the applicable suitability rules. The Memo will also
discuss exemptive, no-action, and interpretive relief granted by the
Commission from Section 11(d)(1) and certain other rules under the Act,
if applicable.
---------------------------------------------------------------------------

    \36\ See supra note 24.
---------------------------------------------------------------------------

    This order is conditioned on the Exchange's adherence to the
foregoing representations.
    The Commission finds good cause for approving this proposal before
the thirtieth day after the publication of notice thereof in the
Federal Register. As referenced above, the Commission notes that the
Fund is substantially similar in structure, operation, and function to
other HealthSharesTM exchange-traded funds, the shares of
which are currently listed and trading on the Exchange pursuant to Rule
19b-4(e) under the Act.\37\ In addition, the Commission notes that it
has previously approved exchange rules that contemplate the listing and
trading of derivative securities products based on indices that were
composed of stocks that did not meet certain quantitative generic
listing criteria by similar amounts.\38\ Although the Fund Shares do
not meet the initial listing requirement of Section 703.16(C)(2)(b)(ii)
of the NYSE Listed Company Manual \39\ and therefore cannot be listed
pursuant to Rule 19b-4(e), the Commission believes that the Shares are
substantially similar to the other HealthSharesTM trading on
the Exchange and notes that the Shares will otherwise comply with all
other ``generic'' listing requirements under Section 703.16.\40\ The
listing and trading of the Shares do not appear to present any new or
significant regulatory concerns. Therefore, the Commission believes
that accelerating approval of this proposal would allow the Shares to
trade on the Exchange without undue delay and should generate
additional competition in the market for such products.
---------------------------------------------------------------------------

    \37\ See supra note 33.
    \38\ See supra note 32.
    \39\ See supra note 8.
    \40\ See id.
---------------------------------------------------------------------------

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\41\ that the proposed rule change (SR-NYSE-2007-46), as modified
by Amendment No. 1, be, and it hereby is, approved on an accelerated
basis.
---------------------------------------------------------------------------

    \41\ 15 U.S.C. 78s(b)(2).

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

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\42\
---------------------------------------------------------------------------

    \42\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-12676 Filed 6-29-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: December 14, 2009 (Volume 74, Number 238)]
[Notices]
[Page 66178]
[DOCID:fr14de09-99]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday,
December 17, 2009 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c), (5), (7), 9(B) and (10) and 17 CFR 200.402(a),
(5), (7), 9(ii) and (10), permit consideration of the scheduled matters
at the Closed Meeting.
    Commissioner Paredes, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
December 17, 2009 will be:

Institution and settlement of injunctive actions; Institution and
settlement of administrative proceedings; Consideration of amicus
participation; and Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: December 10, 2009.
Elizabeth M. Murphy,
Secretary.
 [FR Doc. E9-29796 Filed 12-10-09; 4:15 pm]

BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 209 (Tuesday, November 2, 2021)]
[Rules and Regulations]
[Pages 60368-60372]
[FR Doc No: 2021-23836]

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

40 CFR Part 180

[EPA-HQ-OPP-2020-0391; FRL-8991-01-OCSPP]

Benzobicyclon; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation increases a tolerance for residues of
benzobicyclon in or on rice grain and removes any restriction on
regional use. Gowan Company requested this tolerance increase under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 2, 2021. Objections and
requests for hearings must be received on or before January 3, 2022,
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 docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0391, is available at http://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 is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health emergency, the EPA Docket Center (EPA/DC)
and Reading Room is closed to visitors with limited exceptions. The
staff continues to provide customer service via email, phone, and
webform. For the latest status information on EPA/DC services, docket
access, visit http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
Registration Division (7505P), 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 EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2020-0391 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
January 3, 2022. 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-2020-0391, by one of
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 22, 2021 (86 FR 21317) (FRL-10022-
59) EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0F8831) by

Gowan Company, P.O. Box 5569, Yuma, AZ 85364. The petition requested to
amend the tolerance in 40 CFR 180.693 for residues of the herbicide
benzobicyclon in or on rice to 0.15 parts per million (ppm). That
document referenced a summary of the petition prepared by Gowan, the
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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(b)(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.
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 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 . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for benzobicyclon, including exposure resulting from
the tolerance established by this action. EPA's assessment of exposures
and risks associated with benzobicyclon follows.
    In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemaking of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemaking, and EPA considers referral back to those sections
as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
    EPA has previously published a tolerance rulemaking for
benzobicyclon, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to benzobicyclon and established a
tolerance for residues of that chemical. See the benzobicyclon
tolerance rulemaking published in the Federal Register of April 25,
2017 (82 FR 18995) (FRL-9961-02). EPA is incorporating previously
published sections from that rulemaking that remain unchanged, as
described further in this rulemaking.
    Toxicological profile. There have been updates to the toxicological
profile from the previous assessment. The parent compound,
benzobicyclon, is a pro-pesticide, which means it requires hydrolysis
of the thiophenyl group to generate the anticipated pesticidal active
moiety, metabolite B (also referred to as 1315P-070). The toxicological
database is considered complete for risk assessment purposes for both
the parent, benzobicyclon, and metabolite B. The enzyme 4-
hydroxyphenylpyruvate dioxygenase (HPPD) is involved in the catabolism
of tyrosine, an essential amino acid for mammals. While benzobicyclon
may be referred to as an HPPD inhibitor, typical HPPD-inhibiting
effects are not observed in its toxicological database. However,
metabolite B does exhibit HPPD-inhibiting effects and is therefore
considered an HPPD-inhibiting chemical. The initiating event in the
mode-of-action (MOA)/adverse-outcome pathway (AOP) for HPPD-inhibiting
chemicals, including metabolite B, involves binding of the chemical to
the HPPD enzyme causing complete or virtually complete enzyme
inhibition, which leads to a build-up of systemic tyrosine levels
(tyrosinemia) and a spectrum of tyrosine-mediated effects. In
laboratory animals, these have been identified as ocular and skeletal
developmental effects. Species differences exist in laboratory animals
related to the ability of a species to clear excess tyrosine from its
system, which can impact its sensitivity to HPPD-inhibiting chemicals
and its relevance for human health risk assessment. In this risk
assessment, endpoints were selected for both benzobicyclon and
metabolite B. Taking into account species differences, endpoints for
human health risk assessment of HPPD inhibitors, including metabolite
B, were selected from studies available in mice and dogs. Studies from
other HPPD inhibitors were used for bridging to metabolite B as needed.
Since benzobicyclon does not exhibit HPPD-inhibiting properties,
endpoints were selected from the most sensitive species and effects in
its database (not restricted to mice and dogs).
    Benzobicyclon: An acute dietary endpoint was not selected for
benzobicyclon, as there were no effects attributable to a single dose
identified in the database. The chronic dietary, incidental oral, and
inhalation endpoints were based on increased incidence of hydropic
degeneration (basophilic cells) in the pituitary observed in the two-
generation reproduction toxicity study in rats. A dermal endpoint was
not selected since no hazard was identified in the dermal toxicity
study and there was no evidence of increased quantitative
susceptibility in the database. Benzobicyclon is classified as ``Not
Likely to be Carcinogenic to Humans'' based on the absence of
treatment-related tumors in two adequate rodent carcinogenicity
studies.
    Metabolite B: There were no effects attributable to a single dose
available in the metabolite B database or in studies from other HPPD
inhibitors; therefore, an acute dietary endpoint was not selected for
metabolite B. The chronic dietary endpoint is based on gallstones,
eosinophilic cytoplasmic alteration, subepithelial mixed cell
infiltrate, and dilatation in/of the gallbladder; hepatocellular
vacuolation, hepatocellular hypertrophy, and increased liver weight in
males and females; and papillary mineralization of the kidney and
changes in hematological parameters indicative of anemia in females
observed in the chronic/carcinogenicity study in mice from another HPPD
chemical available for bridging (tembotrione). Since the only
anticipated exposure is through drinking water, no additional points of
departure (PODs) were selected for metabolite B. There are no
carcinogenicity studies available for metabolite B; however,
carcinogenicity studies are available for bridging for all of the other
currently registered HPPD inhibitors. Overall, potential
carcinogenicity is not a concern for the HPPD inhibitors, and the
chronic dietary endpoint and POD for metabolite B is considered
protective of any potential carcinogenicity.
    Additional information is available in the docket for this action
in the document titled ``Benzobicyclon: Section 3 Risk Assessment for
Proposed New Formulation, Increase to the Established Tolerance, and
National Use Expansion on Rice'' (hereafter, the ``Benzobicyclon Human
Health Risk Assessment'').

    Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
benzobicyclon and metabolite B used for human health risk assessment,
please reference section 4.6.3 on pages 25-27 of the ``Benzobicyclon
Human Health Risk Assessment''.
    Exposure assessment. EPA's dietary exposure assessments have been
updated to include the additional exposure from the tolerance increase
on rice grain and national use expansion.
    No effects attributable to a single dose were observed for
benzobicyclon or metabolite B; therefore, acute dietary exposure
assessments were not conducted.
    Based on the toxicological effects of benzobicyclon and metabolite
B, separate chronic dietary exposure and risk assessments were
conducted. The assessments were conducted using Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID) Version 3.16, which uses food consumption data from the
U.S. Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). This
dietary survey was conducted from 2003 to 2008.
    The benzobicyclon chronic dietary exposure assessment assumed
tolerance-level residues for rice, 100 percent crop treated (PCT), and
a modeled estimated drinking water concentration (EDWC) of 0.199 parts
per billion (ppb). The DEEM default processing factor of 1.25 was used
for both rice flour and rice bran.
    There is no anticipated exposure in food to metabolite B. As
metabolite B is only a residue of concern in drinking water, the
chronic dietary exposure assessment was conducted for drinking water
only. The chronic analysis used a modeled EDWC of 4.27 ppb and assumed
100 PCT.
    There are no residential (non-occupational) exposures associated
with benzobicyclon or metabolite B.
    Cumulative exposure. The Agency is required to consider the
cumulative risks of chemicals sharing a common mechanism of toxicity.
The Agency has determined that the (p-hydroxyphenyl-pyruvate
dioxygenase) HPPD inhibitors share a common mechanism of toxicity as
discussed in the document titled ``HPPD Inhibiting Herbicides: State of
the Science,'' which is available in the docket for this action. As
explained in that document, the members of this group of chemicals
share the ability to bind to and inhibit the HPPD enzyme resulting in
elevated systemic tyrosine levels and common apical outcomes that are
mediated by tyrosine, including ocular and developmental effects. In
2021, after establishing a common mechanism grouping for the HPPD
inhibitors, the Agency conducted the ``P-Hydroxyphenyl-Pyruvate
Dioxygenase (HPPD) Inhibitors Cumulative Risk Assessment:
Benzobicyclon, Bicyclopyrone, Isoxaflutole, Mesotrione, Pyrasulfotole,
Tembotrione, Tolpyralate, and Topramezone,'' which is available in the
docket for the action, and concluded that cumulative exposures to HPPD
inhibitors (based on proposed and registered pesticidal uses at the
time the assessment was conducted) did not present risks of concern.
    Safety Factor (SF) for Infants and Children. The Food Quality
Protection Act (FQPA) section has been updated since the last
assessment. EPA has determined that the required FQPA SF of 10X for the
protection of infants and children be reduced to 1X for all exposure
scenarios for benzobicyclon (parent). For metabolite B, since the
chronic dietary endpoint is based on a study with no No-Observed-
Adverse-Effect Level (NOAEL), a 10X FQPA SF/Uncertainty Factor
(UFL) has been retained for extrapolation from a Lowest-
Observed-Adverse-Effect Level (LOAEL) to a NOAEL.
    Completeness of the Toxicology Database: The existing toxicological
database for benzobicyclon is adequate for FQPA evaluation.
Developmental and two-generation reproduction studies in rats are
available for benzobicyclon. However, the active moiety of
benzobicyclon, metabolite B, has been shown to be more toxic than the
parent compound. Therefore, studies were conducted with metabolite B,
including a developmental toxicity study in mice. Additionally, 2-
generation reproduction toxicity studies are available from other HPPD
inhibitors for bridging.
    Evidence of Neurotoxicity: There was no neurotoxicity observed
throughout the database for benzobicyclon or metabolite B. The
subchronic neurotoxicity study with benzobicyclon tested up to 1,290
mg/kg with no adverse effects observed, nor was there evidence of
neurotoxicity in any of the guideline studies in the databases for
either chemical.
    Evidence of Sensitivity/Susceptibility in the Developing or Young
Animal: For benzobicyclon, there was no increased qualitative or
quantitative susceptibility observed in the two-generation reproduction
or developmental toxicity studies in rats. A developmental study in
rabbits was submitted but was considered unacceptable and subsequently
waived by EPA.
    For metabolite B, a developmental toxicity study in mice did not
show any increased qualitative or quantitative susceptibility. A 2-
generation reproduction study is not available for metabolite B;
however, there are 2-generation reproduction studies from other HPPDs
inhibitors that can be used for bridging. In one of the 2-generation
studies in mice for another HPPD inhibitor (mesotrione), quantitative
susceptibility was observed in offspring. However, concern is low
because there are clear NOAEL/LOAEL values for the observed effects,
the offspring LOAEL of 300 mg/kg/day from the mesotrione 2-generation
reproduction toxicity study was set conservatively based on a low
incidence of opaque/cloudy eyes, and the selected endpoints used in
this risk assessment are protective of any potential sensitivity
observed in mice.
    Residual Uncertainty in the Exposure Database: The exposure
databases are complete or are estimated based on data that reasonably
account for potential exposures. There are no registered or proposed
residential uses and/or commercial uses at residential sites for
benzobicyclon at this time. Therefore, a residential exposure
assessment is not required. The dietary exposure assessments (food and
drinking water) are considered to be conservative estimates of
exposure. Tolerance-level residues for rice and 100 PCT were assumed
for the food exposure assessment. Drinking water exposure estimates
(for both benzobicyclon and metabolite B) are based on conservative
models assuming maximum use rates and are not expected to underestimate
the exposure. The Agency is confident that the assessments do not
underestimate risk from dietary exposure to benzobicyclon or metabolite
B.
    Aggregate risks and Determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population-adjusted dose
(aPAD) and the chronic population-adjusted dose (cPAD). Short-,
intermediate-, and chronic term risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the
appropriate points of departure to ensure that an adequate margin of
exposure (MOE) exists. For linear cancer risks, EPA calculates the
lifetime probability of acquiring cancer given the estimated aggregate
exposure.
    There are no acute dietary endpoints for benzobicyclon or
metabolite B; therefore, an acute risk assessment is

unnecessary. Chronic dietary risks are below the Agency's level of
concern of 100% of the cPAD for both benzobicyclon and metabolite B. It
is less than 1% of the cPAD for benzobicyclon for all population
subgroups and 5.8% of the cPAD for metabolite B for all infants less
than 1-year old, the population subgroup with the highest exposure
estimate for both benzobicyclon and metabolite B.
    As noted earlier, there are no residential uses associated with
benzobicyclon. Because there is no short- or intermediate-term
residential exposure and chronic dietary exposure has been assessed
under the appropriately protective cPAD, EPA relies on the chronic
dietary risk assessment for evaluating short- and intermediate-term
risk for benzobicyclon and metabolite B.
    Based on the lack of evidence of carcinogenicity in two adequate
rodent carcinogenicity studies, benzobicyclon is not expected to pose a
cancer risk to humans. For metabolite B, potential carcinogenicity is
not a concern for the HPPD inhibitors and the chronic dietary endpoint
and POD for metabolite B is considered protective of any potential
carcinogenicity.
    Therefore, based on the risk assessments and information described
above, EPA concludes there is reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to benzobicyclon or metabolite B residues. More
detailed information can be found at http://www.regulations.gov in the
Benzobicyclon Human Health Risk Assessment in docket ID number EPA-HQ-
OPP-2020-0391.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method,
see Unit IV.A. of the April 25, 2017 rulemaking (82 FR 18995) (FRL-
9961-02).

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. 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 has not established an MRL for residues of benzobicyclon
in or on rice grain.

V. Conclusion

    Therefore, the tolerance for residues of benzobicyclon on rice,
grain is increased from 0.01 ppm to 0.15 ppm and is no longer a
tolerance with regional restrictions.

VI. Statutory and Executive Order Reviews

    This action increases 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 to 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 tolerance 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).

VII. 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: October 27, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter 1 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. Revise Sec.  180.693 to read as follows:

Sec.  180.693   Benzobicyclon; tolerances for residues.

    (a) General. Tolerances are established for residues of the
herbicide benzobicyclon, including its metabolites and degradates, in
or on the commodity in the table below. Compliance with the tolerance
level specified below is to be determined by measuring only
benzobicyclon, 3-[2-chloro-4-(methylsulfonyl)benzoyl]-4-
(phenylthio)bicyclo-[3.2.1]oct-3-en-2-one), in or on the following raw
agricultural commodity:

                      Table 1 to Sec.   180.693(a)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Rice, grain.............................................            0.15
------------------------------------------------------------------------

    (b)-(d) [Reserved]

[FR Doc. 2021-23836 Filed 11-1-21; 8:45 am]
BILLING CODE 6560-50-P