[Federal Register Volume 85, Number 234 (Friday, December 4, 2020)]
[Notices]
[Pages 78366-78371]
[FR Doc No: 2020-26675]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90530; File No. SR-CboeBZX-2020-085]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Relating
to List and Trade Shares of the Fidelity Growth Opportunities ETF,
Fidelity Magellan ETF, Fidelity Real Estate Investment ETF, and
Fidelity Small-Mid Cap Opportunities ETF Under Rule 14.11(m) (Tracking
Fund Shares)

November 30, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 24, 2020, Cboe BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. 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\ 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 a rule change to list and trade shares of the
Fidelity Growth Opportunities ETF, Fidelity Magellan ETF, Fidelity Real
Estate Investment ETF, and Fidelity Small-Mid Cap Opportunities ETF
(each a ``Fund'' and, collectively, the ``Funds''), each a series of
the Fidelity Covington Trust (the ``Trust''), under Rule 14.11(m),
Tracking Fund Shares. The shares of each Fund are referred to herein as
the ``Shares.''
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the

places specified in Item IV below. The Exchange has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

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

1. Purpose
    The Exchange proposes to list and trade shares of each Fund
pursuant to Rule 14.11(m), Tracking Fund Shares,\3\ which are
securities issued by an actively managed open-end management investment
company.\4\ The Exchange is submitting this proposal as required by
Rule 14.11(m)(2)(A), which provides that the Exchange must file
separate proposals under Section 19(b) of the Act before listing and
trading of a series of Tracking Fund Shares.
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    \3\ As defined in Rule 14.11(m)(3)(A), the term ``Tracking Fund
Share'' means a security that: (i) Represents an interest in an
investment company (``Investment Company'') registered under the
Investment Company Act of 1940 (the ``1940 Act'') 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 and/or a cash amount with a value equal to the next
determined Net Asset Value (``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 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.
    \4\ Rule 14.11(m) was approved along with the listing and
trading of three series of Tracking Fund Shares by the Commission on
May 15, 2020. See Securities Exchange Act Release No. 88887 (May 15,
2020), 85 FR 30990 (May 21, 2020) (the ``Tracking Fund Shares
Approval Order'').
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    The Shares will be offered by the Trust, which is organized as a
business trust under the laws of The Commonwealth of Massachusetts. The
Trust is registered with the Commission as an open-end investment
company and has filed a registration statement on behalf of the Funds
on Form N-1A with the Commission.\5\ Fidelity Management & Research
Company or FMR Co., Inc. (the ``Adviser'') will be the investment
adviser to the Funds. The Adviser is not registered as a broker-dealer,
but is affiliated with numerous broker-dealers. The Adviser represents
that a fire wall exists and will be maintained between the respective
personnel at the Adviser and affiliated broker-dealers with respect to
access to information concerning the composition and/or changes to each
Fund's portfolio and Tracking Basket.\6\ Personnel who make decisions
on a Fund's portfolio composition and/or Tracking Basket or who have
access to nonpublic information regarding the Fund Portfolio \7\ and/or
the Tracking Basket or changes thereto are subject to procedures
designed to prevent the use and dissemination of material non-public
information regarding such portfolio and/or Tracking Basket. The Funds'
sub-advisers, FMR Investment Management (UK) Limited, Fidelity
Management & Research (Hong Kong) Limited, and Fidelity Management &
Research (Japan) Limited (each a ``Sub-Adviser'' and, collectively, the
``Sub-Advisers''), are not registered as a broker-dealer but are
affiliated with numerous broker-dealers. Sub-Adviser personnel who make
decisions regarding a Fund's Fund Portfolio and/or Tracking Basket or
who have access to information regarding the Fund Portfolio and/or the
Tracking Basket or changes thereto are subject to procedures designed
to prevent the use and dissemination of material nonpublic information
regarding the Fund's portfolio and/or Tracking Basket. In the event
that (a) the Adviser or a Sub-Adviser becomes registered as a broker-
dealer or newly affiliated with a broker-dealer; or (b) any new adviser
or sub-adviser is a registered broker-dealer or becomes newly
affiliated with a broker-dealer; it will implement and maintain a fire
wall with respect to its relevant personnel or such broker-dealer
affiliate, as applicable, regarding access to information concerning
the composition and/or changes to the Fund Portfolio and/or Tracking
Basket, and will be subject to procedures designed to prevent the use
and dissemination of material non-public information regarding such
portfolio and/or Tracking Basket. Any person or entity, including any
service provider for the Funds, who has access to nonpublic information
regarding a Fund Portfolio or Tracking Basket or changes thereto for a
Fund or Funds will be subject to procedures designed to prevent the use
and dissemination of material nonpublic information regarding the
applicable Fund Portfolio or Tracking Basket or changes thereto.
Further, any such person or entity that is registered as a broker-
dealer or affiliated with a broker-dealer, has erected and will
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 or Tracking Basket. Each Fund
intends to qualify each year as a regulated investment company under
Subchapter M of the Internal Revenue Code of 1986, as amended.
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    \5\ The Trust is registered under the 1940 Act. On September 24,
2020, the Trust filed a registration statement on Form N-1A relating
to the Funds (File No. 811-07319) (the ``Registration Statement'').
The descriptions of the Funds and the Shares contained herein are
based, in part, on information included in the Registration
Statement. The Commission has issued an order granting certain
exemptive relief under the Investment Company Act of 1940 (15 U.S.C.
80a-1) to Fidelity Management & Research Company and FMR Co., Inc.,
Fidelity Beach Street Trust, and Fidelity Distributors Corporation
(File No. 812-14364), issued on December 10, 2019 (the
``Application,'' ``Notice,'' and ``Order,'' respectively, and,
collectively, the ``Exemptive Order''). See Investment Company Act
Release Nos. 33683 (November 14, 2019), 84 FR 64140 (November 20,
2019) (the Notice) and 33712 (the Order).
    \6\ As defined in Rule 14.11(m)(3)(E), 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.
    \7\ As defined in Rule 14.11(m)(3)(B), the term ``Fund
Portfolio'' means the identities and quantities of the securities
and other assets held by the Investment Company that will form the
basis for the Investment Company's calculation of net asset value at
the end of the business day.
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    The Shares will conform to the initial and continued listing
criteria under Rule 14.11(m) as well as all terms in the Exemptive
Order. The Exchange represents that, for initial and/or continued
listing, each Fund will be in compliance with Rule 10A-3 under the
Act.\8\ A minimum of 100,000 Shares of each Fund will be outstanding at
the commencement of trading on the Exchange. The Exchange will obtain a
representation from the issuer of the Shares of each Fund that the NAV
per share of each Fund will be calculated daily and will be made
available to all market participants at the same time. Each Fund's
investments will be consistent with its investment objective and will
not be used to enhance leverage.
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    \8\ See 17 CFR 240.10A-3.
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Fidelity Growth Opportunities ETF
    The Fund's holdings will conform to the permissible investments as
set forth in the Exemptive Relief and the holdings will be consistent
with all requirements in the Exemptive Relief.\9\

Any foreign common stocks held by the Fund will be traded on an
exchange that is a member of the Intermarket Surveillance Group
(``ISG'') \10\ or with which the Exchange has in place a comprehensive
surveillance sharing agreement.
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    \9\ Pursuant to the Exemptive Relief, the Fund's permissible
investments include only the following instruments: ETFs, exchange-
traded notes, exchange-traded common stocks, common stocks listed on
a foreign exchange that trade on such exchange contemporaneously
with the Shares (``foreign common stocks''), exchange-traded
preferred stocks, exchange-traded American Depositary Receipts
(``ADRs''), exchange-traded real estate investment trusts, exchange-
traded commodity pools, exchange-traded metals trusts, exchange-
traded currency trusts, and exchange-traded futures that trade
contemporaneously with the Shares, as well as cash and cash
equivalents. With the exception of foreign common stocks and cash
and cash equivalents, all holdings of the Fund will be listed on a
U.S. national securities exchange.
    \10\ For a list of the current members of ISG, see
www.isgportal.com. The Exchange notes that all components, except
the cash and cash equivalent components, of the Funds may trade on
markets that are members of ISG or with which the Exchange has in
place a comprehensive surveillance sharing agreement.
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    The Fund seeks long-term growth of capital. In order to achieve its
investment objective, the Fund typically invests primarily in equity
securities of domestic and foreign issuers that the Adviser believes
have above-average growth potential, as determined using fundamental
analysis of factors such as each issuer's financial condition and
industry position, as well as market and economic conditions.
Fidelity Magellan ETF
    The Fund's holdings will conform to the permissible investments as
set forth in the Exemptive Relief and the holdings will be consistent
with all requirements in the Exemptive Relief.\11\ Any foreign common
stocks held by the Fund will be traded on an exchange that is a member
of ISG or with which the Exchange has in place a comprehensive
surveillance sharing agreement.\12\
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    \11\ Pursuant to the Exemptive Relief, the Fund's permissible
investments include only the following instruments: ETFs, exchange-
traded notes, exchange-traded common stocks, foreign common stocks,
exchange-traded preferred stocks, ADRs, exchange-traded real estate
investment trusts, exchange-traded commodity pools, exchange-traded
metals trusts, exchange-traded currency trusts, and exchange-traded
futures that trade contemporaneously with the Shares, as well as
cash and cash equivalents. With the exception of foreign common
stocks and cash and cash equivalents, all holdings of the Fund will
be listed on a U.S. national securities exchange.
    \12\ For a list of the current members of ISG, see
www.isgportal.com. The Exchange notes that all components, except
the cash and cash equivalent components, of the Funds may trade on
markets that are members of ISG or with which the Exchange has in
place a comprehensive surveillance sharing agreement.
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    The Fund seeks long-term growth of capital. In order to achieve its
investment objective, the Fund typically invests primarily in equity
securities of domestic and foreign issuers that, based on fundamental
analysis of factors such as each issuer's financial condition and
industry position, as well as market and economic conditions, the
Adviser believes are ``growth'' stocks or ``value'' stocks or both.
Fidelity Real Estate Investment ETF
    The Fund's holdings will conform to the permissible investments as
set forth in the Exemptive Relief and the holdings will be consistent
with all requirements in the Exemptive Relief.\13\ Any foreign common
stocks held by the Fund will be traded on an exchange that is a member
of the Intermarket Surveillance Group (``ISG'') \14\ or with which the
Exchange has in place a comprehensive surveillance sharing agreement.
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    \13\ Pursuant to the Exemptive Relief, the Fund's permissible
investments include only the following instruments: ETFs, exchange-
traded notes, exchange-traded common stocks, foreign common stocks,
exchange-traded preferred stocks, ADRs, exchange-traded real estate
investment trusts, exchange-traded commodity pools, exchange-traded
metals trusts, exchange-traded currency trusts, and exchange-traded
futures that trade contemporaneously with the Shares, as well as
cash and cash equivalents. With the exception of foreign common
stocks and cash and cash equivalents, all holdings of the Fund will
be listed on a U.S. national securities exchange.
    \14\ For a list of the current members of ISG, see
www.isgportal.com. The Exchange notes that all components, except
the cash and cash equivalent components, of the Funds may trade on
markets that are members of ISG or with which the Exchange has in
place a comprehensive surveillance sharing agreement.
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    The Fund seeks above-average income and long-term capital growth,
consistent with reasonable investment risk. In order to achieve its
investment objective, the Fund normally invests at least 80% of assets
in securities of companies principally engaged in the real estate
industry and other real estate related investments. Such investments
are primarily in equity securities of domestic and foreign issuers
based on fundamental analysis of factors such as each issuer's
financial condition and industry position, as well as market and
economic conditions.
Fidelity Small-Mid Cap Opportunities ETF
    The Fund's holdings will conform to the permissible investments as
set forth in the Exemptive Relief and the holdings will be consistent
with all requirements in the Exemptive Relief.\15\ Any foreign common
stocks held by the Fund will be traded on an exchange that is a member
of the Intermarket Surveillance Group (``ISG'') \16\ or with which the
Exchange has in place a comprehensive surveillance sharing agreement.
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    \15\ Pursuant to the Exemptive Relief, the Fund's permissible
investments include only the following instruments: ETFs, exchange-
traded notes, exchange-traded common stocks, foreign common stocks,
exchange-traded preferred stocks, ADRs, exchange-traded real estate
investment trusts, exchange-traded commodity pools, exchange-traded
metals trusts, exchange-traded currency trusts, and exchange-traded
futures that trade contemporaneously with the Shares, as well as
cash and cash equivalents. With the exception of foreign common
stocks and cash and cash equivalents, all holdings of the Fund will
be listed on a U.S. national securities exchange.
    \16\ For a list of the current members of ISG, see
www.isgportal.com. The Exchange notes that all components, except
the cash and cash equivalent components, of the Funds may trade on
markets that are members of ISG or with which the Exchange has in
place a comprehensive surveillance sharing agreement.
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    The Fund seeks long-term growth of capital. In order to achieve its
investment objective, the Fund normally invests at least 80% of assets
in securities of companies with small to medium market capitalizations
(which, for purposes of this fund, are those companies with market
capitalizations similar to companies in the Russell 2500TM
Index) by investing in domestic and foreign issuers that, based on
fundamental analysis of factors such as each issuer's financial
condition and industry position, as well as market and economic
conditions, the Adviser believes are ``growth'' stocks or ``value''
stocks or both.
Trading Halts
    Rule 14.11(m)(4)(B)(iv) provides that (a) the Exchange may consider
all relevant factors in exercising its discretion to halt trading in a
series of Tracking Fund Shares. Trading may be halted because of market
conditions or for reasons that, in the view of the Exchange, make
trading in the Shares inadvisable. These may include: (i) The extent to
which trading is not occurring in the securities and/or the financial
instruments composing the Tracking Basket or Fund Portfolio; or (ii)
whether other unusual conditions or circumstances detrimental to the
maintenance of a fair and orderly market are present; and (b) if the
Exchange becomes aware that one of the following is not being made
available to all market participants at the same time: The net asset
value, the Tracking Basket, or the Fund Portfolio with respect to a
series of Tracking Fund Shares, then the Exchange will halt trading in
such series until such time as the net asset value, the Tracking
Basket, or the Fund Portfolio is available to all market participants,
as applicable.
Trading Rules
    The Exchange deems Tracking Fund Shares to be equity securities,
thus rendering trading in the Shares subject to the Exchange's existing
rules governing the trading of equity securities.\17\ As provided in
Rule

14.11(m)(2)(C), the minimum price variation for quoting and entry of
orders in securities traded on the Exchange is $0.01. The Exchange has
appropriate rules to facilitate trading in Tracking Fund Shares during
all trading sessions.
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    \17\ With respect to trading in Tracking Fund Shares, all of the
BZX Member obligations relating to product description and
prospectus delivery requirements will continue to apply in
accordance with Exchange rules and federal securities laws, and the
Exchange will continue to monitor its Members for compliance with
such requirements.
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Tracking Basket for the Proposed Funds
    For the Funds, the Tracking Basket will consist of a combination of
the Fund's recently disclosed portfolio holdings and representative
ETFs. The Exchange notes that the Tracking Basket methodology used by
the Fund is substantively identical to a proposal previously approved
by the Commission.\18\ ETFs selected for inclusion in the Tracking
Basket will be consistent with the Fund's objective and selected based
on certain criteria, including, but not limited to, liquidity, assets
under management, holding limits and compliance considerations.
Representative ETFs can provide a useful mechanism to reflect a Fund's
holdings' exposures within the Tracking Basket without revealing a
Fund's exact positions.\19\ Intraday pricing information for all
constituents of the Tracking Basket that are exchange-traded, which
includes all eligible instruments except cash and cash equivalents,
will be available on the exchanges on which they are traded and through
subscription services. Intraday pricing information for cash
equivalents will be available through subscription services and/or
pricing services. The Exchange notes that each Fund's NAV will form the
basis for creations and redemptions for the Funds and creations and
redemptions will work in a manner substantively identical to that of
series of Managed Fund Shares. The Adviser expects that the Shares of
the Funds will generally be created and redeemed in-kind, with limited
exceptions. The names and quantities of the instruments that constitute
the basket of securities for creations and redemptions will be the same
as a Fund's Tracking Basket, except to the extent purchases and
redemptions are made entirely or in part on a cash basis. In the event
that the value of the Tracking Basket is not the same as a Fund's NAV,
the creation and redemption baskets will consist of the securities
included in the Tracking Basket plus or minus an amount of cash equal
to the difference between the NAV and the value of the Tracking Basket,
as further described below.
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    \18\ See Tracking Fund Shares Approval Order.
    \19\ The set of ETFs that are ``representative'' to be used in
the Tracking Basket will depend on certain factors, including the
Fund's investment objective, past holdings, and benchmark, and may
change from time to time. For example, a U.S. diversified fund
benchmarked to a diversified U.S. index would use liquid U.S.
exchange-traded ETFs to capture size (large, mid or small
capitalization), style (growth or value) and/or sector exposures in
the Fund's portfolio. Leveraged and inverse ETFs will not be
included in the Tracking Basket. ETFs may constitute no more than
50% of the Tracking Basket's assets.
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    The Tracking Basket will be constructed utilizing a covariance
matrix based on an optimization process to minimize deviations in the
return of the Tracking Basket relative to the Fund. The proprietary
optimization process mathematically seeks to minimize three key
parameters that the Adviser believes are important to the effectiveness
of the Tracking Basket as a hedge: Tracking error (standard deviation
of return differentials between the Tracking Basket and the Fund),
turnover cost, and basket creation cost.\20\ Typically, the Tracking
Basket is expected to be rebalanced on schedule with the public
disclosure of the Fund's holdings; however, a new optimized Tracking
Basket may be generated as frequently as daily, and therefore,
rebalancing may occur more frequently at the Adviser's discretion. In
determining whether to rebalance a new optimized Tracking Basket, the
Adviser will consider various factors, including liquidity of the
securities in the Tracking Basket, tracking error, and the cost to
create and trade the Tracking Basket.\21\ For example, if the Adviser
determines that a new Tracking Basket would reduce the variability of
return differentials between the Tracking Basket and the Fund when
balanced against the cost to trade the new Tracking Basket, rebalancing
may be appropriate. The Adviser will periodically review the Tracking
Basket parameters and Tracking Basket performance and process.
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    \20\ Tracking error measures the deviations between the Tracking
Basket and Fund. Turnover cost and basket creation cost are measures
of the cost to create and maintain the Tracking Basket as a hedge.
    \21\ The Adviser uses a trading cost model to develop estimates
of costs to trade a new Tracking Basket. There are essentially two
elements to this cost: (1) The cost to purchase securities
constituting the Tracking Basket, i.e., the cost to put on the hedge
for the Authorized Participant, and (2) the cost of any adjustments
that need to be made to the composition of the Tracking Basket,
i.e., the cost to the Authorized Participant to change or maintain
the hedge position. The inclusion of the trading cost model in the
optimization process is intended to result in a Tracking Basket that
is cost effective and liquid without compromising its tracking
ability.
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    As noted above, each Fund will also disclose the entirety of its
portfolio holdings, including the name, identifier, market value and
weight of each security and instrument in the portfolio, at a minimum
within at least 60 days following the end of every fiscal quarter. The
Exchange notes that the concept of the Tracking Basket employed under
this structure is designed to provide investors with the traditional
benefits of ETFs while protecting the Funds from the potential for
front running or free riding of portfolio transactions, which could
adversely impact the performance of a Fund.
    The Exchange believes that the particular instruments that may be
included in each of the Fund's respective Fund Portfolio and Tracking
Basket do not raise any concerns related to the Tracking Baskets being
able to closely track the NAV of the Funds because such instruments
include only instruments that trade on an exchange contemporaneously
with the Shares.\22\ In addition, each Fund's Tracking Basket will be
optimized so that it reliably and consistently correlates to the
performance of the Fund.
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    \22\ The Exchange notes that to the extent that the Fund
Portfolio or Tracking Basket include any foreign common stocks, such
securities will be traded on an exchange that is a member of ISG or
with which the Exchange has in place a comprehensive surveillance
sharing agreement.
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    The Adviser anticipates that the returns between a Fund and its
respective Tracking Basket will have a consistent relationship and that
the deviation in the returns between a Fund and its Tracking Basket
will be sufficiently small such that the Tracking Basket will provide
authorized participants, arbitrageurs, and certain other market
participants (collectively, ``Market Makers'') with a reliable hedging
vehicle that they can use to effectuate low-risk arbitrage trades in
Fund Shares. The Exchange believes that the disclosures provided by the
Funds will allow Market Makers to understand the relationship between
the performance of a Fund and its Tracking Basket. Market Makers will
be able to estimate the value of and hedge positions in a Fund's
Shares, which the Exchange believes will facilitate the arbitrage
process and help ensure that the Fund's Shares normally will trade at
market prices close to their NAV. The Exchange also believes that
competitive market making, where traders are looking to take advantage
of differences in bid-ask spread, will aid in keeping spreads tight.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with Section
6(b) of the Act \23\ in general and Section 6(b)(5) of the Act \24\ in
particular in that

it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system and,
in general, to protect investors and the public interest.
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    \23\ 15 U.S.C. 78f.
    \24\ 15 U.S.C. 78f(b)(5).
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    The Exchange notes that a significant amount of information about
each Fund and its Fund Portfolio will be publicly available at all
times. Each Fund will disclose the Tracking Basket, which is designed
to closely track the daily performance of the Fund Portfolio, on a
daily basis. Each Fund will at a minimum publicly disclose the entirety
of its portfolio holdings, including the name, identifier, market value
and weight of each security and instrument in the portfolio within at
least 60 days following the end of every fiscal quarter in a manner
consistent with normal disclosure requirements otherwise applicable to
open-end investment companies registered under the 1940 Act. The
website will include additional quantitative information updated on a
daily basis, including, on a per Share basis for each Fund, the prior
business day's NAV and the closing price or bid/ask price at the time
of calculation of such NAV, and a calculation of the premium or
discount of the closing price or bid/ask price against such NAV. The
website will also disclose the percentage weight overlap between the
holdings of the Tracking Basket compared to the Fund Holdings for the
prior business day and any information regarding the bid/ask spread for
each Fund as may be required for other ETFs under Rule 6c-11 under the
1940 Act, as amended. Price information for the exchange-listed
instruments held by the Funds, including both U.S. and non-U.S. listed
equity securities and U.S. exchange-listed futures will be available
through major market data vendors or securities exchanges listing and
trading such securities.
    The Exchange represents that the Shares of the Funds will continue
to comply with all other requirements applicable to Tracking Fund
Shares, including the dissemination of key information such as the
Tracking Basket, the Fund Portfolio, and NAV, suspension of trading or
removal, trading halts, surveillance, minimum price variation for
quoting and order entry, an information circular informing members of
the special characteristics and risks associated with trading in the
Shares, and firewalls as set forth in the Rules applicable to Tracking
Fund Shares and the order approving such rules. Moreover, U.S.-listed
equity securities held by the Funds will trade on markets that are a
member of ISG or with which the Exchange has in place a comprehensive
surveillance sharing agreement.\25\ All statements and representations
made in this filing regarding the description of the portfolio or
reference assets, limitations on portfolio holdings or reference
assets, dissemination and availability of reference asset (as
applicable), or the applicability of Exchange listing rules specified
in this filing shall constitute continued listing requirements for the
Shares. The issuer has represented to the Exchange that it will advise
the Exchange of any failure by a Fund or Shares to comply with the
continued listing requirements, and, pursuant to its obligations under
Section 19(g)(1) of the Act, the Exchange will surveil for compliance
with the continued listing requirements. FINRA conducts certain cross-
market surveillances on behalf of the Exchange pursuant to a regulatory
services agreement. The Exchange is responsible for FINRA's performance
under this regulatory services agreement. If a Fund is not in
compliance with the applicable listing requirements, the Exchange will
commence delisting procedures with respect to such Fund under Exchange
Rule 14.12.
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    \25\ See supra note 10.
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    The Exchange believes that the proposal is designed to prevent
fraudulent and manipulative acts and practices in that the Rules
relating to listing and trading of Tracking Fund Shares provide
specific initial and continued listing criteria required to be met by
such securities.
    Rules 14.11(m)(4)(B)(iii) and (iv) provide that the Exchange will
consider the suspension of trading in and will commence delisting
proceedings for a Fund pursuant to Rule 14.12 under any of the
circumstances described above and that the Exchange may consider all
relevant factors in exercising its discretion to halt trading in a
series of Tracking Fund Shares. Trading may be halted because of market
conditions or for reasons that, in the view of the Exchange, make
trading in the Shares inadvisable.
    Additionally, the Exchange believes that the requirements related
to information protection enumerated under Rule 14.11(m)(2)(F) will act
as a strong safeguard against any misuse and improper dissemination of
information related to a Fund Portfolio, the Tracking Basket, or
changes thereto. The requirement that any person or entity, including a
custodian, Reporting Authority, distributor, or administrator, who has
access to nonpublic information regarding the Fund Portfolio or the
Tracking Basket or changes thereto, must be subject to procedures
designed to prevent the use and dissemination of material nonpublic
information regarding the applicable Fund Portfolio or the Tracking
Basket or changes thereto will act to prevent any individual or entity
from sharing such information externally.
    The Exchange believes that its surveillance procedures are adequate
to properly monitor the trading of the Shares on the Exchange during
all trading sessions and to deter and detect violations of Exchange
rules and the applicable federal securities laws. Trading of the Shares
through the Exchange will be subject to the Exchange's surveillance
procedures for derivative products, including Tracking Fund Shares. If
a Fund is not in compliance with the applicable listing requirements,
the Exchange will commence delisting procedures under Exchange Rule
14.12. In addition, the Exchange also has a general policy prohibiting
the distribution of material, non-public information by its employees.
Any foreign common stocks held by the Fund will be traded on an
exchange that is a member of ISG or with which the Exchange has in
place a comprehensive surveillance sharing agreement. All futures
contracts that the Funds may invest in will be traded on a U.S. futures
exchange. The Exchange or FINRA, on behalf of the Exchange, or both,
will communicate as needed regarding trading in the Shares, underlying
U.S. exchange-listed equity securities, and U.S. exchange-listed
futures with other markets and other entities that are members of ISG,
and the Exchange or FINRA, on behalf of the Exchange, or both, may
obtain trading information regarding trading such instruments from such
markets and other entities. In addition, the Exchange may obtain
information regarding trading in the Shares, underlying equity
securities, and U.S. exchange-listed futures from markets and other
entities that are members of ISG or with which the Exchange has in
place a comprehensive surveillance sharing agreement.
    As provided in Rule 14.11(m)(2)(D), the Adviser will upon request
make available to the Exchange and/or FINRA, on behalf of the Exchange,
the daily Fund Portfolio of each Fund. The Exchange believes that the
ability to access the information on an as needed basis will provide it
with sufficient

information to perform the necessary regulatory functions associated
with listing and trading the Shares on the Exchange, including the
ability to monitor compliance with the initial and continued listing
requirements as well as the ability to surveil for manipulation of the
Shares.
    In addition, Form N-PORT requires reporting of a fund's complete
portfolio holdings on a position-by-position basis on a quarterly basis
within 60 days after fiscal quarter end. Investors can obtain a fund's
Statement of Additional Information, its Shareholder Reports, its Form
N-CSR, filed twice a year, and its Form N-CEN, filed annually. A fund's
SAI and Shareholder Reports are available free upon request from the
Investment Company, and those documents and the Form N-PORT, Form N-
CSR, and Form N-CEN may be viewed on-screen or downloaded from the
Commission's website at www.sec.gov. The Exchange also notes that the
Exemptive Relief provides that the Funds will comply with Regulation
Fair Disclosure, which prohibits selective disclosure of any material
non-public information, which otherwise do not apply to issuers of
Tracking Fund Shares.
    Information regarding market price and trading volume of the Shares
will be continually available on a real-time basis throughout the day
on brokers' computer screens and other electronic services. Information
regarding the previous day's closing price and trading volume
information for the Shares will be published daily in the financial
section of newspapers. Quotation and last sale information for the
Shares will be available via the CTA high-speed line. The Exchange
deems Tracking Fund Shares to be equity securities, thus rendering
trading in the Shares subject to the Exchange's existing rules
governing the trading of equity securities. As provided in Rule
14.11(m)(2)(C), the minimum price variation for quoting and entry of
orders in securities traded on the Exchange is $0.01.
    For the above reasons, the Exchange believes that the proposed rule
change is consistent with the requirements of Section 6(b)(5) of the
Act.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purpose of the Act. Rather, the Exchange notes
that the proposed rule change will facilitate the listing of several
new series of actively-managed exchange-traded product, thus enhancing
competition among both market participants and listing venues, to the
benefit of investors and the marketplace.

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

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

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \26\ and Rule 19b-
4(f)(6) thereunder.\27\
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78s(b)(3)(A).
    \27\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    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.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CboeBZX-2020-085 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-CboeBZX-2020-085. 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-CboeBZX-2020-085 and should be submitted
on or before December 28, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\28\
---------------------------------------------------------------------------

    \28\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-26675 Filed 12-3-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 194 (Friday, October 5, 2018)]
[Notices]
[Page 50382]
[FR Doc No: 2018-21677]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3464]

Policy Regarding Quantitative Labeling of Dietary Supplements
Containing Live Microbials; Draft Guidance for Industry; Availability;
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; correction.

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

SUMMARY: The Food and Drug Administration (FDA or we) is correcting a
document that appeared in the Federal Register of September 7, 2018 (83
FR 45454). The document announced the draft guidance for industry
entitled ``Policy Regarding Quantitative Labeling of Dietary
Supplements Containing Live Microbials.'' The notice inadvertently
contained the wrong docket number. This document corrects that error.

DATES: This notice is applicable October 5, 2018.

FOR FURTHER INFORMATION CONTACT: Steven Tave, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, September
7, 2018, appearing on page 45454 in FR. Doc. 2018-19367, the following
corrections are made:
    On page 45454, in the docket heading in column 1, the docket number
appearing in square brackets is corrected to be FDA-2018-D-3464.
    On page 45454, in the ``Instructions,'' in column 2, the Docket No.
is corrected to be FDA-2018-D-3464.

    Dated: October 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21677 Filed 10-4-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 75, Number 81 (Wednesday, April 28, 2010)]
[Rules and Regulations]
[Pages 22256-22263]
[FR Doc No: 2010-9759]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0162; FRL-8817-3]

 Difenoconazole Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the
fungicide difenoconazole in or on: Almond, hulls; brassica, head and
stem, subgroup 5A; brassica, leafy green, subgroup 5B; citrus, dried
pulp; citrus, oil; fruit, citrus, group 10; grape; grape, raisin; nut,
tree, group 14; onion, bulb, subgroup 3-07A; onion, green, subgroup 3-
07B; pistachio; and vegetable, cucurbit, group 9. EPA is also revising
the difenoconazole crop and animal tolerance expressions; deleting all
section 18 difenoconazole tolerances that are no longer needed as a
result of this action; reinstating tolerances for wheat forage, wheat
grain, and wheat straw, which were inadvertently removed when previous
tolerances were established; correcting the existing tolerance for
beet, sugar; and deleting the grape import superscript. Syngenta Crop
Protection, Inc. requested the new tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 28, 2010. Objections and
requests for hearings must be received on or before June 28, 2010, 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-2009-0162. 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 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 (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Rosemary Kearns, Registration Division
(7505P), 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 those
engaged in the following activities:
     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 to
provide 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 EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr. To
access the OPPTS Harmonized Test Guidelines referenced in this document
electronically, please go to http://www.epa.gov/oppts and select ``Test
Methods & Guidelines'' on the left-side navigation menu.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2009-0162 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before June 28, 2010.
    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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0162, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (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. Petition for Tolerance

    In the Federal Register of April 8, 2009 (74 FR 15971) (FRL-8407-
4), 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 petition (PP
8F7482) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR 180.475 be amended by
establishing tolerances for residues of the fungicide difenoconazole,
1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-
ylmethyl]-1H-1,2,4-triazole, in or on: Almond, hulls at 7 ppm;
brassica, head and stem, subgroup 5A at 1.9 ppm; brassica, leafy green,
subgroup 5B at 30 ppm; citrus, dried pulp at 2.5 ppm; citrus, oil at 28
ppm; fruit, citrus, group 10 at 0.6 ppm; grape at 4 ppm; grape, raisin
at 14 ppm; nut, tree, group 14 at 0.03 ppm; onion, bulb, subgroup 3-07A
at 6 ppm; onion, green, bulb, subgroup 3-07B at 0.15 ppm; pistachios at
0.03 ppm; vegetable, cucurbit, group 9 at 0.7 ppm. Although a tree nut
group tolerance is being established, a separate pistachio tolerance is
needed because pistachios are not currently part of the tree nut, group
14. That notice referenced a summary of the petition prepared by
Syngenta Crop Protection, Inc., the registrant, which is available to
the public in the docket, 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
increased the proposed tolerance for both brassica, leafy green,
subgroup 5B; and onion, green, subgroup 3-07B. EPA has decreased the
proposed tolerance for citrus, dried pulp; citrus, oil; grape, raisin;
and onion, bulb, subgroup 3-07A. EPA is also revising the
difenoconazole crop and animal tolerance expressions; deleting all
difenoconazole section 18 tolerances that are no longer needed as a
result of this action; reinstating tolerances for wheat forage, wheat
grain, and wheat straw, which were inadvertently removed when previous
tolerances were established; deleting the grape import superscript
designation; and correcting the existing tolerance for beet, sugar. The
reasons for these changes are explained in Unit IV.D.

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 section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for
tolerances for residues of difenoconazole in or on almond, hulls at 7.0
ppm; brassica, head and stem, subgroup 5A at 1.9 ppm; brassica, leafy
greens, subgroup 5B at 35 ppm; citrus, dried pulp at 2.0 ppm; citrus,
oil at 25 ppm; fruit, citrus, group 10 at 0.60 ppm; grape at 4.0 ppm;
grape, raisin at 6.0 ppm; nut, tree, group 14 at 0.03 ppm; onion, bulb,
subgroup 3-07A at 0.20 ppm; onion, green, subgroup 3-07B at 6.0 ppm;
pistachio at 0.03 ppm; and vegetable, cucurbit, group 9 at 0.70 ppm.
EPA's assessment of exposures and risks associated with establishing
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Difenoconazole possesses low acute toxicity by the oral, dermal and

inhalation routes of exposure. It is not considered to be an eye or
skin irritant and is not a sensitizer. Difenoconazole exhibits some
evidence of neurotoxicity in the database, but the effects are
transient or occur at doses exceeding the limit dose. It is not
mutagenic and it is not a developmental or reproductive toxicant.
Chronic effects in rats and mice are seen as cumulative decreases in
body weight gains.
    No evidence of carcinogenicity was seen in rats. Evidence for
carcinogenicity was seen in mice where liver tumors were induced at
doses which were considered to be excessively high for carcinogenicity
testing. Treatment-related non-neoplastic lesions were confined to the
liver. Difenoconazole is classified as a possible human carcinogen.
Based on excessive toxicity observed at the doses at which tumors were
seen, the absence of tumors at the lower doses, and the absence of
genotoxic effects, EPA considers the cancer effects to be a threshold
effect.
    Specific information on the studies received and the nature of the
adverse effects caused by difenoconazole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Difenoconazole FQPA Human Health Risk
Assessment for the Section 3 Registration of Difenoconazole New Uses on
Bulb Vegetables, Brassica Leafy Vegetables, Cucurbit Vegetables, Citrus
Fruits, Grapes, Pistachios, and Tree Nuts'' at pages 51-63 in docket ID
number EPA-HQ-OPP-2009-0162.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a benchmark dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the level of concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for difenoconazole used
for human risk assessment can be found at http://www.regulations.gov in
document ``Difenoconazole FQPA Human Health Risk Assessment for the
Section 3 Registration of Difenoconazole New Uses on Bulb Vegetables,
Brassica Leafy Vegetables, Cucurbit Vegetables, Citrus Fruits, Grapes,
Pistachios, and Tree Nuts'' at pages 16-18 in docket ID number EPA-HQ-
OPP-2009-0162.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to difenoconazole, EPA considered exposure under the
petitioned-for tolerances as well as all existing difenoconazole
tolerances in 40 CFR 180.475. EPA assessed dietary exposures from
difenoconazole in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA assumed
tolerance-level residues, 100% crop treated for all the registered and
proposed crops, and default processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-
level residues for some commodities, field trial residues for the
majority of commodities, and 100% crop treated. EPA used experimental
processing factors for some crops and default processing factors for
the remainder.
    iii. Cancer. A quantitative exposure assessment to evaluate cancer
risk is unnecessary. The cancer NOAEL for difenoconazole is higher than
the NOAEL used as a Point of Departure in calculating the chronic RfD.
Therefore, chronic exposure would be equal to or greater than the
exposure value used in assessing cancer risk, and the chronic dietary
risk estimate is protective of any cancer effects.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use PCT information in the dietary assessment for
difenoconazole. EPA did use anticipated residues in the chronic dietary
assessment for difenoconazole; field trial residues and experimental
processing factors were used for some commodities.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such Data Call-Ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for difenoconazole in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of difenoconazole. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on using PRZM/EXAMS and Screening Concentration in Ground
Water (SCI-GROW) models, the estimated drinking water concentrations

(EDWCs) of difenoconazole for acute exposures are estimated to be 15.8
parts per billion (ppb) for surface water and 0.0123 ppb for ground
water. EDWCs for chronic exposures for non-cancer assessments are
estimated to be 10.4 ppb for surface water and 0.0123 ppb for ground
water.
    EDWCs for chronic exposures for cancer assessments are estimated to
be 7.62 ppb for surface water and 0.0123 ppb for ground water. These
EDWCs are the same or lower than the EDWC for chronic non-cancer
exposure.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
    For acute dietary risk assessment, the water concentration value of
15.8 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of
value 10.4 ppb was used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Difenoconazole is currently registered for the following uses that
could result in residential exposures: ornamentals. EPA assessed
residential exposure using the following assumptions: No new
residential uses are being requested at this time. However, adults and
adolescents may be exposed to difenoconazole from its currently
registered use on ornamentals.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' Difenoconazole is a member
of the triazole-containing class of pesticides, often referred to as
the conazoles. EPA is not currently following a cumulative risk
approach based on a common mechanism of toxicity for the conazoles. The
conazole pesticides, as a whole, tend to exhibit carcinogenic,
developmental, reproductive, and/or neurological effects in mammals.
Additionally, all the members of this class of compounds are capable of
forming, via environmental and metabolic activities, 1,2,4-triazole,
triazolylalanine and/or triazolylacetic acid. These metabolites have
also been shown to cause developmental, reproductive, and/or
neurological effects. Structural similarities and sharing a common
effect does not constitute a common mechanism of toxicity. Evidence is
needed to establish that the chemicals operate by the same, or
essentially the same sequence of major biochemical events. Hence, the
underlying basis of toxicity is the same, or essentially the same for
each chemical. A number of potential events could contribute to the
toxicity of conazoles (e.g., altered cholesterol levels, stress
responses, altered DNA methylation). At this time, there is not
sufficient evidence to determine whether conazoles share common
mechanisms of toxicity. Without such understanding, there is no basis
to make a common mechanism of toxicity finding for the diverse range of
effects found. Investigations into the conazoles are currently being
undertaken by EPA's Office of Research and Development. When the
results of this research are available, the Agency will make a
determination of whether there is a common mechanism of toxicity and,
therefore, a basis for assessing cumulative risk. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.
    Triazole-derived pesticides can form the common metabolite 1,2,4-
triazole and three triazole conjugates (triazole alanine, triazole
acetic acid, and triazolylpyruvic acid). To support existing tolerances
and to establish new tolerances for triazole-derivative pesticides,
including prothioconazole, EPA conducted a human health risk assessment
for exposure to 1,2,4-triazole, triazole alanine, and triazole acetic
acid resulting from the use of all current and pending uses of any
triazole-derived fungicide as of September 1, 2005. The risk assessment
is a highly conservative, screening-level evaluation in terms of
hazards associated with common metabolites (e.g., use of a maximum
combination of uncertainty factors) and potential dietary and non-
dietary exposures (i.e., high end estimates of both dietary and non-
dietary exposures). In addition, the Agency retained the additional 10X
FQPA safety factor for the protection of infants and children. The
assessment included evaluations of risks for various subgroups,
including those comprised of infants and children. The Agency's
September 1, 2005 risk assessment can be found in the propiconazole
reregistration docket at http://www.regulations.gov (docket ID EPA-HQ-
OPP-2005-0497).
    In October and December of 2008, EPA updated the dietary and
aggregate risk assessments for exposure to 1,2,4-triazole, triazole
alanine, triazole acetic acid, and triazolylpyruvic acid resulting from
the use of all current and pending uses of any triazole-derived
fungicide to support existing tolerances and to establish new
tolerances for new uses of metconazole (canola, corn, cotton, and
sugarcane; PP 7F7221, 7F7292, 08FL03), propiconazole (beets, parsley,
and pineapple; PP 7F7300), prothioconazole (wheat and barley; PP
7F7279), and tetraconazole (grapes; PP 7E7273). These updated dietary
and aggregate assessments are below the Agency's level of concern.
These updated triazole risk assessments can be found in the rule's
docket (EPA-HQ-OPP-2008-0327) and the following associated dockets at
http://www.regulations.gov.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. 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.
    2. Prenatal and postnatal sensitivity. The Agency determined that
the available studies indicate no increased susceptibility of rats or
rabbits to in utero and/or postnatal exposure to difenoconazole. In the
prenatal developmental toxicity studies in rats and rabbits and the
two-generation reproduction study in rats, toxicity to the fetuses/
offspring, when observed, occurred at equivalent or higher dosed than
in the maternal/parental animals. The developmental toxicity was
manifested as alterations in fetal ossifications at 171 mg/kg/day; the
developmental NOAEL was 85 mg/kg/day. In a developmental toxicity study
in rabbits, maternal and developmental toxicity were seen at the same
dose level (75 mg/kg/day). Maternal toxicity in rabbits were manifested
as decreased in body weight gain and decreased in food consumption,
while developmental toxicity was manifested as decreased

fetal weight. In a 2-generation reproduction study in rats, there were
decreases in maternal body weight gain and decreases in body weights of
F1 males at the LOAEL of 12.5 mg/kg/day; the parental systemic and off
spring toxicity NOAEL was 1.25 mg/kg/day.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for difenoconazole is adequate for
conducting this risk assessment. In accordance with 40 CFR part 158
toxicology data requirements, an immunotoxicity study (OPPTS Harmonized
Guideline 870.7800) is required for difenoconazole. In the absence of
specific immunotoxicity studies, EPA has evaluated the available
difenoconazole toxicity data to determine whether an additional
database uncertainty factor is needed to account for potential
immunotoxicity. There are no indications in the available studies that
organs associated with immune function, such as the thymus and spleen,
are affected by difenoconazole, and difenoconazole does not belong to a
class of chemicals (e.g., the organotins, heavy metals, or halogenated
aromatic hydrocarbons) that would be expected to be immunotoxic.
Therefore, EPA does not believe that conducting immunotoxicity testing
will result in a point of departure lower than those already selected
for difenoconazole risk assessment, and an additional database
uncertainty factor is not needed to account for the lack of this study.
    ii. Difenoconazole exhibits some evidence of neurotoxicity in the
database, but the effects are transient or occur at doses exceeding the
limit dose. There is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no indication of increased susceptibility of rats or
rabbits fetuses to in utero and/or postnatal exposure in the
developmental and reproductive toxicity data.
    iv. Although some storage stability data are still required,
tolerances and field trial data used in the risk assessment are
sufficiently high, that even if residues degrade in frozen storage
prior to analysis, the risk assessment will be protective. Although a
confined rotational crop study is still required, the plant back
interval is sufficiently long that no detectable residues are expected
in rotated commodities. Furthermore, conservative (protective) acute
dietary food exposure assessments were performed based on 100% crop
trested and tolerance-level residues. Chronic dietary exposure
assessments were based on tolerance-level residues for some
commodities, field trial residues for the majority of commodities, and
experimental processing factor for some crops, and 100% crop treated.
The field trial data and experimental processing factors from
processing studies are based on reliable data from the maximum use
rate, and are unlikely to understate the residues. EPA also made
conservative (protective) assumptions in the ground water and surface
water modeling used to assess exposure to difenoconazole in drinking
water. EPA used similarly conservative assumptions to assess post-
application exposure of children as well as incidental oral exposure of
toddlers. These assessments will not underestimate the exposure and
risks posed by difenoconazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions described in this
unit for acute exposure, EPA has concluded that acute exposure to
difenoconazole from food and water will utilize 16% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
difenoconazole from food and water will utilize 44% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
difenoconazole are not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Difenoconazole is currently registered for ornamentals that could
result in short-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with short-term residential exposures to difenoconazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures aggregated result in aggregate MOEs of at
least 180. Values higher than 100 are not of concern. The proposed
residential scenarios result in exposure only to adults. Therefore,
short-term aggregate assessments were not conducted for infants and
children.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Difenoconazole is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to difenoconazole through food and water, which has already been
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. As discussed above
the chronic dietary risk assessment is protective of any cancer
effects.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to difenoconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical methodology is available to enforce the
tolerances listed under 40 CFR 180.475. Method AG-575B (gas
chromatography/nitrogen-phosphorus detection) is available for
enforcement in crops, and Method AG-676 (gas chromatography/mass
selective detection) is available for confirmation. Method AG-676A is
available for enforcement and confirmation in canola and barley. Method
REM 147.07b (liquid chromatography/mass spectrometry/mass spectrometry)
is available for enforcement in livestock and methods AG-544A (gas
chromatography/nitrogen-phosphorus

detection) and REM 147.06 (high performance liquid chromatography/UV
detection), which determine difenoconazole and CGA 205375,
respectively, are available for confirmation. These methods may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    Codex Maximum Residue Limits (MRLs) for residues of difenoconazole
per se have been established at 0.3 ppm for leek, 0.5 ppm for broccoli,
0.2 ppm for Brussels sprouts, 0.2 ppm for cabbage, 0.2 ppm for
cauliflower, and 0.1 ppm for grape. Canadian and Mexican MRLs have been
established for difenoconazole; however, no MRLs have been established
for the requested crops. Based on the submitted field trial data for
brassica vegetables, green onions, and grapes, harmonization with
established Codex MRLs is not possible because the MRLs for brassica
vegetables, leek, and grape are lower than residue values seen in U.S.
field trials. This is a result of differences in agricultural
practices.

C. Response to Comments

    There were no public comments received.

D. Revisions to Petitioned-For Tolerances

    1. The existing time-limited section 18 tolerances in/on almond and
almond, hulls are 0.05 ppm, and 5.0 ppm, respectively. This rule
establishes new tolerances in/on the nut, tree, group 14 (which
includes almonds); and on almond, hulls, at 0.03 ppm and 7.0 ppm,
respectively. As explained below, keeping the currently established
higher section 18 tolerance in/on almond (0.05 ppm) is not needed and
is being revoked, and because a new higher tolerance for almond, hulls
is being established at 7.0 ppm, the currently established lower
section 18 tolerances in/on almond, hulls (5.0 ppm) is also being
revoked.
    The section 18 tolerances were based on the same almond field trial
study used to establish the new section 3 nut, tree, group 14
tolerance, and to revise the almond, hulls tolerance. The original data
were submitted by Interregional Research Project Number 4 (IR-4) in
support of the section 18 and then samples were transferred to Syngenta
where they were re-analyzed and the new re-analysis data were submitted
in support of this section 3 petition. The differences in the analyses/
re-analyses data of the same almond and almond hulls samples is the
reason for the differences in section 18 and section 3 tolerance
determinations. It should be noted that in the original data submitted
by IR-4, residues in/on all nutmeat samples were determined to be <0.05
ppm and so the section 18 tolerance in/on almonds was set at 0.05 ppm.
    2. The existing time-limited section 18 tolerances for cantaloupe,
cucumber, and watermelon are all 1.0 ppm. This rule establishes a new
tolerance for vegetable, cucurbit group 9 (which includes all three
crops) at a lower tolerance of 0.70 ppm. The section 18 tolerances are
based on translation from available fruiting vegetable data using a 1-
day PHI. For this petition, Syngenta has provided actual cucurbit
vegetable data reflecting the section 18 use rate and a more
conservative 0-day PHI, which resulted in a lower tolerance. Therefore,
separate higher tolerances at 1.0 ppm are not needed for cantaloupe,
cucumber, and watermelon, and the section 18 tolerances in/on these
crops are being revoked.
    3. Based upon review of the residue data supporting the petition,
EPA has increased the proposed tolerance for brassica, leafy green,
subgroup 5B from 30 ppm to 35 ppm.
    4. The registrant requested a tolerance for bulb onions, subgroup
3-07A at 6.0 ppm, and for green onions, subgroup 3-07B at 0.15 ppm.
These proposed tolerances appear to have been transposed by the
petitioner. Based on the submitted residue data, EPA is establishing
tolerances at 0.20 ppm for onions, bulb, subgroup 3-07A and at 6.0 ppm
for onions, green, subgroup 3-07B.
    5. EPA has decreased the proposed tolerances for citrus, dried pulp
(2.5 ppm); citrus, oil (28 ppm); and grape, raisin (14 ppm). The
processing data indicate the proposed tolerances for processed
commodities are too high and that tolerances of 2.0 ppm for citrus,
dried pulp; 25 ppm for citrus, oil; and 6.0 ppm for grape, raisin are
appropriate.
    6. EPA is revising the existing difenoconazole tolerance
expressions in paragraphs (a)(1) and (a)(2) to clarify what needs to be
analyzed for tolerance compliance.
    7. Tolerances are being reinstated at 0.1 ppm for wheat forage;
wheat grain; and wheat straw. These tolerances were inadvertently
removed from 40 CFR 180.475(a) as a result of a rulemaking that added
new difenoconazole tolerances but used inaccurate terminology as to how
the CFR was to be amended. (73 FR 1503, January 9, 2008) (FRL-8343-5).
    8. The petitioner previously requested beet, sugar at 0.3 ppm via
petition 6F7115 which published August 22, 2007. (72 FR 47010) (FRL-
8142-5). The associated rule for that petition published January 9,
2008, and erroneously established this tolerance at 0.01 ppm even
though the preamble to that rule noted that the petition sought a
tolerance level 0.3 ppm. (73 FR 1503, January 9, 2008). Therefore, the
existing beet sugar tolerance is being revised from 0.01 to 0.3 ppm to
correct this inadvertent error.
    9. Revising the existing grape tolerance and deleting the import
superscript designation which is no longer needed.

V. Conclusion

    Therefore, tolerances are established for residues of the
fungicide, difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-
4methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on almond,
hulls at 7.0 ppm; brassica, head and stem, subgroup 5A at 1.9 ppm;
brassica, leafy greens, subgroup 5B at 35 ppm; citrus, dried pulp at
2.0 ppm; citrus, oil at 25 ppm; fruit, citrus, group 10 at 0.60 ppm;
grape at 4.0 ppm; grape, raisin at 6.0 ppm; nut, tree, group 14 at 0.03
ppm; onion, bulb, subgroup 3-07A at 0.20 ppm; onion, green, subgroup 3-
07B at 6.0 ppm; pistachio at 0.03 ppm; and vegetable, cucurbit, group 9
at 0.70 ppm. This rule also revises the crop and animal difenoconazole
tolerance expressions; deletes all section 18 difenoconazole tolerances
that are no longer needed as a result of this action; reinstates 0.1
ppm tolerances for wheat forage, wheat grain, and wheat straw; corrects
the existing tolerance for beet, sugar to 0.3 ppm; and deletes the
grape import superscript designation.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA 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 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 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, nor does this
action 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, 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 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) (Public Law 104-4).
    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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. 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: April 19, 2010.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

0
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 180.475 is amended by revising paragraph (a)(1); revising
(a)(2) introductory text; and removing and reserving paragraph (b).

Sec.  180.475  Difenoconazole; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of
difenoconazole, including its metabolites and degradates, in or on the
commodities in the following table. Compliance with the tolerance
levels specified below is to be determined by measuring only
difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-
dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on the following raw
agricultural commodities:

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Almond, hulls.........................................                                                       7.0
Apple, wet pomace.....................................                                                       4.5
Banana\1\.............................................                                                       0.2
Barley, grain.........................................                                                       0.1
Barley, hay...........................................                                                      0.05
Barley, straw.........................................                                                      0.05
Beet, sugar...........................................                                                       0.3
Beet, sugar, dried pulp...............................                                                       1.9
Brassica, head and stem, subgroup 5A..................                                                       1.9
Brassica, leafy green, subgroup 5B....................                                                        35
Canola, seed..........................................                                                      0.01
Citrus, dried pulp....................................                                                       2.0
Citrus, oil...........................................                                                        25
Corn, sweet, forage...................................                                                      0.01
Corn, sweet, kernel plus cob with husks removed.......                                                      0.01
Corn, sweet, stover...................................                                                      0.01
Cotton, gin byproducts................................                                                      0.05
Cotton, undelinted seed...............................                                                      0.05
Fruit, citrus, group 10...............................                                                      0.60
Fruit, pome group 11..................................                                                       1.0
Grape.................................................                                                       4.0
Grape, raisin.........................................                                                       6.0
Nut, tree, group 14...................................                                                      0.03
Onion, bulb, subgroup 3-07A...........................                                                      0.20
Onion, green, subgroup 3-07B..........................                                                       6.0
Papaya\1\.............................................                                                      0.30
Pistachio.............................................                                                      0.03
Potato, processed waste...............................                                                      0.04
Rye, grain\1\.........................................                                                       0.1
Vegetable, cucurbit, group 9..........................                                                      0.70

Vegetable, fruiting, group 8..........................                                                      0.60
Vegetable, tuberous and corm, subgroup 1C.............                                                      0.01
Wheat, forage.........................................                                                       0.1
Wheat, grain..........................................                                                       0.1
Wheat, straw..........................................                                                       0.1
----------------------------------------------------------------------------------------------------------------
\1\There are no U.S. registrations.

    (2) Tolerances are established for residues of difenoconazole,
including its metabolites and degradates, in the commodities in the
table below. Compliance with the tolerance levels specified below is to
be determined by measuring difenoconazole, 1-[2-[2-chloro-4-(4-
chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-
triazole, and its metabolite, CGA-205375, 1-[2-chloro-4-(4-chloro-
phenoxy)phenyl]-2-[1,2,4]triazol-1-yl-ethanol, in the following
commodities:
* * * * *
    (b) Section 18 emergency exemptions. [Reserved]
* * * * *

[FR Doc. 2010-9759 Filed 4-27-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register: December 31, 2007 (Volume 72, Number 249)]
[Notices]
[Page 74281]
[DOCID:fr31de07-42]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12557-001]

SBER Royal Mills, LLC; Notice of Application Tendered for Filing
With the Commission, Soliciting Additional Study Requests, and
Establishing a Deadline for Submission of Final Amendments

December 19, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Exemption From Licensing.
    b. Project No.: P-12557-001.
    c. Date Filed: December 12, 2007.
    d. Applicant: SBER Royal Mills, LLC.
    e. Name of Project: Royal Mills Hydroelectric Project.
    f. Location: On the South Branch Pawtuxet River, in the town of
West Warwick, Kent County, Rhode Island. This project does not occupy
federal lands.
    g. Filed Pursuant to: Public Utilities Regulatory Policies Act of
1978, 16 U.S.C. 2705, 2708.
    h. Applicant Contact: Quentin Chafee, Development Director,
Struever Bros. Eccles & Rouse, Inc., 166 Valley Street, Building 6M,
Suite 103, Providence, RI 02909,<PHONE_NUMBER><EMAIL_ADDRESS>    i. FERC Contact: Steve Kartalia<EMAIL_ADDRESS>(202)
502-6131.
    j. Cooperating Agencies: We are asking Federal, State, and local
agencies and Indian tribes with jurisdiction and/or special expertise
with respect to environmental issues to cooperate with us in the
preparation of the environmental document. Agencies who would like to
request cooperating status should follow the instructions for filing
comments described in item l below.
    k. Pursuant to Section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian tribe, or person believes
that an additional scientific study should be conducted in order to
form a factual basis for complete analysis of the application on its
merits, the resource agency, Indian tribe, or person must file a
request for the study with the Commission no later than 60 days from
the application filing date, and serve a copy of the request on the
applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: February 11, 2008.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE, Washington, DC 20426.
    Additional study requests may be filed electronically via the
Internet in lieu of paper. The Commission strongly encourages
electronic filing. See 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site (http://www.ferc.gov) under the

``eFiling'' link. After logging into the eFiling system, select
``Comment on Filing'' from the Filing Type Selection screen and
continue with the filing process.''
    m. The application is not ready for environmental analysis at this
time.
    n. Project Description: The Royal Mills Hydroelectric Project would
consist of the following facilities: (1) an existing 110-foot-long by
21-foot-high granite block dam; (2) the existing 3.8-acre reservoir,
(3) an existing 150-foot-long by 40-foot-wide power canal; (4) an
existing powerhouse containing one single new cross-flow turbine
generating unit with total installed generating capacity of 225
kilowatts (kW); and (5) appurtenant facilities. The restored project
would have an estimated average annual generation of 1,000,000
kilowatt-hours. The dam and existing project facilities are owned by
the applicant.
    o. A copy of the application is on file with the Commission and is
available for public inspection. This filing may also 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
filed to access the documents. For assistance, please contact FERC
Online Support at<EMAIL_ADDRESS>or toll free at (866) 208-
3676 or for TTY, contact<PHONE_NUMBER>. A copy is also available for
inspection and reproduction at the address in item h above.
    p. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    q. With this notice, we are initiating consultation with the RHODE
ISLAND HISTORIC PRESERVATION OFFICER (SHPO), as required by Sec.  106,
National Historic Preservation Act, and the regulations of the Advisory
Council on Historic Preservation, 36 CFR 800.4.
    r. Final amendments:
    Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-25326 Filed 12-28-07; 8:45 am]

BILLING CODE 6717-01-P