[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Pages 57192-57193]
[FR Doc No: 2021-22334]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3563-EM; Docket ID FEMA-2021-0001]

Rhode Island; Amendment No. 2 to Notice of an Emergency
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the State of Rhode Island (FEMA-3563-EM), dated August 21, 2021, and
related determinations.

DATES: This change occurred on September 14, 2021.

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

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Robert V.
Fogel, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of Benjamin Abbott as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling;

97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-22334 Filed 10-13-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 153 (Wednesday, August 8, 2012)]
[Notices]
[Pages 47444-47448]
[FR Doc No: 2012-19350]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67558; File No. SR-BATS-2012-030]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing of Proposed Rule Change To Amend BATS Rule 14.11, Entitled
``Other Securities''

August 1, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'' or ``Exchange Act''),\1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that, on July 20, 2012, BATS Exchange, Inc.
(``Exchange'' or ``BATS'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared 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 to amend Rule 14.11, entitled ``Other
Securities,'' to modify the criteria for certain securities listed on
BATS Exchange as Index Fund Shares. The text of the proposed rule
change is available at the Exchange's Web site at http://www.batstrading.com, at the principal office of the Exchange, and at
the Commission's Public Reference Room. The proposed rule text can be
found in Exhibit 5.

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 parts of such
statements.

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

1. Purpose
Proposal To Amend Index Fund Shares Rules
    The Exchange proposes certain changes to Rule 14.11(c), relating to
Index Fund Shares, to conform the Exchange's listings criteria for
Index Fund Shares with the analogous criteria in place for NYSE Arca
Equities, Inc. (``NYSE Arca'').\3\ Specifically, the Exchange proposes
to amend Exchange Rule 14.11(c) (``Index Fund Shares'') to: (1) Modify
the weight and volume requirement for component stocks comprising the
applicable index or portfolio for any U.S. index or portfolio and any
international or global index or portfolio upon which Index Fund Shares
are based; (2) exclude Index Fund Shares, Portfolio Depositary
Receipts, Trust Issued Receipts, and Managed Fund Shares (collectively,
``Derivative Securities Products'')\4\ when applying the quantitative
generic listing criteria in Rule 14.11(c); and (3) modify the minimum
number of component stocks for any U.S. index or portfolio and any
international or global index or portfolio upon which Index Fund Shares
are based to adopt certain exceptions for any index or portfolio that
is partially or wholly comprised of Index Fund Shares or other
Derivative Securities Products.
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    \3\ The Exchange notes that NYSE Arca uses the term Investment
Company Units to describe the same products that the Exchange calls
Index Fund Shares.
    \4\ Rule 14.11 includes criteria for derivative securities that
may be listed or traded on the Exchange, such as Portfolio
Depositary Receipts, Trust Issued Receipts, and Managed Fund Shares.
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    Rule 14.11(c)(3) provides that the Exchange may approve a series of
Index Fund Shares for listing and trading pursuant to Rule 19b-4(e)\5\
under the Act if such series satisfies the criteria set forth in that
rule. The Exchange proposes to amend Rule 14.11(c)(3) to amend the
index weight requirements and adopt notional volume traded per month\6\
to the initial listing standards for Index Fund Shares, commonly
referred to as exchange-traded funds. The Exchange proposes to amend
the minimum component stock weight requirement for monthly trading
volumes from 90% to 70% of the weight of the underlying index. In
addition, the Exchange proposes to adopt an alternative notional volume
traded per month.
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    \5\ 17 CFR 240.19b-4(e). Rule 19b-4(e) provides that the listing
and trading of a new derivative securities product by a self-
regulatory organization (``SRO'') shall not be deemed a proposed
rule change, pursuant to Rule 19b-4(c)(1), if the Commission has
approved, pursuant to Section 19(b) of the Exchange Act, the SRO's
trading rules, procedures, and listing standards for the product
class that would include the new derivatives securities product, and
the SRO has a surveillance program for the product class.
    \6\ The notional volume traded per month is the number of shares
traded in a calendar month multiplied by the monthly closing price.
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    Currently for U.S. component stock indexes, Rule
14.11(c)(3)(A)(i)(b) provides that component stocks that in the
aggregate account for at least 90% of the weight of the index or
portfolio each shall have a minimum monthly trading volume during each
of the last six months of at least 250,000 shares. The Exchange
proposes to amend the minimum component stock weight requirement from
90% to 70% of the weight of the underlying index or portfolio. Further,
the Exchange is proposing to adopt an average minimum trading volume
requirement of 250,000 shares over a six-month period instead of in
each of the last six months and to adopt a notional volume traded per
month of $25,000,000 averaged over the

last six months as an option for meeting the listing requirements.
    Currently for international or global indexes, Rule
14.11(c)(3)(A)(ii)(b) provides that component stocks that in the
aggregate account for at least 90% of the weight of the index or
portfolio each shall have a minimum worldwide monthly trading volume
during each of the last six months of at least 250,000 shares. The
Exchange proposes to amend the minimum component stock weight
requirement from 90% to 70% of the weight of the underlying index or
portfolio. Further, the Exchange is proposing to adopt an average
minimum trading volume requirement of 250,000 shares over a six-month
period instead of in each of the last six months and to adopt a
worldwide notional volume traded per month of $25,000,000 averaged over
the last six months as an option for meeting the listing requirements.
Further, the Exchange proposes to clarify that the component stock
trading volumes are determined on a global basis.
    With regard to the Exchange's proposal to amend the minimum
component stock weight requirement for monthly trading volumes from 90%
to 70% of the weight of the underlying index, the Exchange believes the
proposed standard reasonably ensures that securities with substantial
monthly trading volumes account for a substantial portion of the
underlying index and, when applied in conjunction with the other
applicable listing requirements, remain sufficiently broad-based in
scope to minimize potential manipulation. The Exchange notes that the
Commission has previously approved the listing and trading of exchange-
traded funds based upon indices that were composed of stocks that did
not meet the 90% monthly trading volume weight, but were above the
proposed 70% monthly trading volume weight criteria.\7\ In addition,
this standard would conform to existing NYSE Arca requirements approved
by the Commission.\8\
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    \7\ See Securities Exchange Act Release No. 46306 (August 2,
2002), 67 FR 51916 (August 9, 2002) (SR-NYSE-2002-28) (approving the
following funds for trading pursuant to unlisted trading privileges
on NYSE: (1) Vanguard Total Stock Market VIPERs; (2) iShares Russell
2000 Index Funds; (3) iShares Russell 2000 Value Index Funds; and
(4) iShares Russell 2000 Growth Index Fund); Securities Exchange Act
Release No. 55953 (June 25, 2007), 72 FR 36084 (July 2, 2007) (SR-
NYSE-2007-46) (approving listing on NYSE of HealthShares Orthopedic
Repair Exchange-Traded Fund); and Securities Exchange Act Release
No. 56695 (October 24, 2007), 72 FR 61413 (October 30, 2007) (SR-
NYSEArca-2007-111) (approving listing on NYSE Arca of HealthShares
Ophthalmology Exchange-Traded Fund).
    \8\ See NYSE Arca Rule 5.2(j)(3), Commentary .01(a)(A) and (B);
see also Securities Exchange Act Release No. 61240 (December 24,
2009), 75 FR 168 (January 4, 2010) (SR-NYSEArca-2009-101) (approving
proposed rule change to amend NYSE Arca Equities Rule 5.2(j)(3)).
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    With respect to adopting, as an alternative to monthly trading
volume, the notional volume traded for each of the last six months to
the initial listing standards for both domestic and international
indexes, the Exchange believes that notional volume traded averaged per
month is a better measure of the liquidity of component stocks of the
underlying index or indexes. Specifically, notional volume nullifies
the volume discrepancies that generally occur between low priced and
high priced stocks.\9\
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    \9\ For example, a stock priced at $10 per share that trades
2,500,000 shares in a month has a notional volume of $25,000,000.
Conversely, a stock priced at $100 per share that trades 250,000
shares in a month has a notional volume of $25,000,000.
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    With respect to adopting a six-month average, instead of in each of
the last six-months, criterion for volume and notional volume, the
Exchange believes that the averaged six-month period is a better
indicator of the current liquidity on an index and serves to eliminate
seasonal volume fluctuations of component securities. Further,
investors, exchange-traded fund issuers, and third-party index sponsors
would also benefit from the Exchange's ability to list--without the
delay associated with a stand-alone rule filing--Index Fund Shares
based on a broader group of indexes promoting competition.
    The Exchange also proposes to exclude Derivative Securities
Products when applying the quantitative listing requirements of Rule
14.11(c)(3)(A)(i)(a), (b), and (c) and 14.11(c)(3)(A)(ii)(a), (b), and
(c) relating to listing of Index Fund Shares based on a U.S index or
portfolio or an international or global index or portfolio,
respectively. Component stocks in the aggregate, excluding Derivative
Securities Products, would be required to meet the criteria of these
provisions. Thus, for example, when determining the component weight
for the most heavily weighted stock and the five most heavily weighted
component stocks for an underlying index that includes a Derivative
Securities Product, the weight of any Derivative Securities Products
included in the underlying index or portfolio would not be considered.
    In addition, the Exchange proposes to modify the requirement in
Rule 14.11(c)(3)(A)(i)(d) that an index or portfolio shall include a
minimum of 13 component stocks for an index or portfolio that includes
Derivative Securities Products. Specifically, the Exchange proposes
that there shall be no minimum number of component stocks if (a) one or
more series of Index Fund Shares or Portfolio Depositary Receipts (as
defined in Exchange Rule 14.11(b)) constitute, at least in part,
components underlying a series of Index Fund Shares, or (b) one or more
series of Derivative Securities Products account for 100% of the weight
of the index or portfolio. Thus, for example, if the index or portfolio
underlying a series of Index Fund Shares includes one or more series of
Index Fund Shares or Portfolio Depositary Receipts, or if it consists
entirely of other Derivative Securities Products, then there would not
be required to be any minimum number of component stocks (i.e., one or
more components would be acceptable). However, if the index or
portfolio consists of Derivative Securities Products other than Index
Fund Shares or Portfolio Depositary Receipts (e.g., Managed Fund
Shares) as well as securities that are not Derivative Securities
Products (e.g., common stocks), then there would have to be at least 13
components in the underlying index or portfolio.
    In addition, the Exchange proposes to modify the requirement in
14.11(c)(3)(A)(ii)(d) that an index or portfolio shall include a
minimum of 20 component stocks for an international or global index or
portfolio that includes Derivative Securities Products. Specifically,
the Exchange proposes that there shall be no minimum number of
component stocks if (a) one or more series of Index Fund Shares or
Portfolio Depositary Receipts (as defined in Exchange Rule 14.11(b))
constitute, at least in part, components underlying a series of Index
Fund Shares, or (b) one or more series of Derivative Securities
Products account for 100% of the weight of the index or portfolio.
Thus, for example, if the index or portfolio underlying a series of
Index Fund Shares includes one or more series of Index Fund Shares or
Portfolio Depositary Receipts, or if it consists entirely of other
Derivative Securities Products, then there would not be required to be
any minimum number of component stocks (i.e., one or more components
would be acceptable). However, if the index or portfolio consists of
Derivative Securities Products other than Index Fund Shares or
Portfolio Depositary Receipts (e.g., Managed Fund Shares) as well as
securities that are not Derivative Securities Products (e.g., common
stocks), then there would have to be at

least 20 components in the underlying index or portfolio.
    The Exchange believes it is appropriate to exclude Derivative
Securities Products from the generic criteria specified above for Index
Fund Shares and to adopt the above-described exceptions in so far as
Derivative Securities Products that may be included in an index or
portfolio underlying a series of Index Fund Shares are themselves
subject to specific listing and continued listing requirements of the
national securities exchange on which they are listed. Such Derivative
Securities Products would have been listed and traded on a national
securities exchange pursuant to a filing submitted pursuant to Section
19(b)(2) \10\ or 19(b)(3)(A) \11\ of the Act, or would have been listed
by a national securities exchange pursuant to the requirements of Rule
19b-4(e)\12\ under the Act. Finally, Derivative Securities Products are
derivatively priced, and, therefore, it is not necessary to apply the
generic quantitative criteria (market capitalization, trading volume,
index or portfolio component weighting) applicable to non-Derivative
Securities Products (e.g., common stocks) to such products.
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    \10\ 15 U.S.C. 78s(b)(2).
    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(e).
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    In addition to the changes set forth above, the Exchange proposes
to correct a typographical error in Rule 14.11(c)(4), where there
currently are two sub-sections (c)(4)(B). The Exchange proposes to
change the second reference to (c)(4)(C).
General Provisions
    To the extent not specifically addressed in the proposed rules, the
following general provisions of the Exchange's rules will continue to
apply to all subject securities affected by the proposed rules
(``securities'').
Information Circular
    Prior to the commencement of trading, the Exchange will inform its
Members in an Information Circular of the special characteristics and
risks associated with trading the securities. Specifically, the
Information Circular will discuss the following: (1) The procedures for
purchases and redemptions of the securities (and/or that the securities
are not individually redeemable); (2) Exchange Rule 3.7, which imposes
suitability obligations on Exchange Members with respect to
recommending transactions in the securities to customers; (3) how
information regarding the Intraday Indicative Value is disseminated;
(4) the risks involved in trading the securities during the Pre-Opening
\13\ and After Hours Trading Sessions \14\ when an updated Intraday
Indicative Value will not be calculated or publicly disseminated; (5)
the requirement that Members deliver a prospectus to investors
purchasing newly issued securities prior to or concurrently with the
confirmation of a transaction; and (6) trading information.
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    \13\ The Pre-Opening Session is from 8:00 a.m. to 9:30 a.m.
Eastern Time.
    \14\ The After Hours Trading Session is from 4:00 p.m. to 5:00
p.m. Eastern Time.
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    In addition, the Information Circular will advise Members, prior to
the commencement of trading, of the prospectus delivery requirements
applicable to the securities. Members purchasing securities for resale
to investors will deliver a prospectus to such investors. The
Information Circular will also discuss any exemptive, no-action, and
interpretive relief granted by the Commission from any rules under the
Act.
    In addition, the Information Circular will reference that the
securities are subject to various fees and expenses described in the
registration statement. The Information Circular will also disclose the
trading hours of the securities and, if applicable, the Net Asset Value
(``NAV'') calculation time for the securities. The Information Circular
will disclose that information about the securities and the
corresponding indexes, if applicable, will be publicly available on the
Web site for the securities.
Trading Rules
    The Exchange deems the securities to be equity securities, thus
rendering trading in the securities subject to the Exchange's existing
rules governing the trading of equity securities. The securities will
trade on the Exchange from 8:00 a.m. until 5:00 p.m. Eastern Time. The
Exchange has appropriate rules to facilitate transactions in the
securities during all trading sessions. The minimum price increment for
quoting and entry of orders in equity securities traded on the Exchange
is $0.01, with the exception of securities that are priced less than
$1.00 for which the minimum price increment for order entry is
$0.0001.\15\
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    \15\ See, e.g., Rule 11.11(a). Regulation NMS Rule 612, Minimum
Pricing Increment, provides:
    a. No national securities exchange, national securities
association, alternative trading system, vendor, or broker or dealer
shall display, rank, or accept from any person a bid or offer, an
order, or an indication of interest in any NMS stock priced in an
increment smaller than $0.01 if that bid or offer, order, or
indication of interest is priced equal to or greater than $1.00 per
share.
    b. No national securities exchange, national securities
association, alternative trading system, vendor, or broker or dealer
shall display, rank, or accept from any person a bid or offer, an
order, or an indication of interest in any NMS stock priced in an
increment smaller than $0.0001 if that bid or offer, order, or
indication of interest is priced less than $1.00 per share.
    c. The Commission, by order, may exempt from the provisions of
this section, either unconditionally or on specified terms and
conditions, any person, security, quotation, or order, or any class
or classes of persons, securities, quotations, or orders, if the
Commission determines that such exemption is necessary or
appropriate in the public interest, and is consistent with the
protection of investors.
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Surveillance
    The Exchange believes that its surveillance procedures are adequate
to address any concerns about the trading of the securities on the
Exchange. Trading of the securities on the Exchange will be subject to
the Exchange's surveillance procedures for derivative products,
including the securities. The Exchange may obtain information via the
Intermarket Surveillance Group (``ISG'') from other exchanges who are
members or affiliates of the ISG \16\ or with which the Exchange has
entered into a comprehensive surveillance sharing agreement. The
Exchange has a general policy prohibiting the distribution of material,
non-public information by its employees.
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    \16\ For a list of the current members and affiliate members of
ISG, see www.isgportal.com.
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Trading Halts
    With respect to trading halts, the Exchange may consider all
relevant factors in exercising its discretion to halt or suspend
trading in the securities. Trading in the securities may be halted
because of market conditions or for reasons that, in the view of the
Exchange, make trading in the securities inadvisable. These may
include: (1) The extent to which trading in the underlying asset or
assets is not occurring; or (2) whether other unusual conditions or
circumstances detrimental to the maintenance of a fair and orderly
market are present. In addition, trading in the securities will be
subject to trading halts caused by extraordinary market volatility
pursuant to Rule 11.18 or by the halt or suspension of the trading of
the current underlying asset or assets.
    If the applicable Intraday Indicative Value, value of the
underlying index, or the value of the underlying asset or assets (e.g.,
securities, commodities, currencies, futures contracts, or other
assets) is not being disseminated as required, the Exchange may halt
trading

during the day in which such interruption to the dissemination occurs.
If the interruption to the dissemination of the applicable Intraday
Indicative Value, value of the underlying index, or the value of the
underlying asset or assets persists past the trading day in which it
occurred, the Exchange will halt trading no later than the beginning of
the trading day following the interruption. In addition, if the
Exchange becomes aware that the NAV with respect to a series of the
securities is not disseminated to all market participants at the same
time, it will halt trading in such series until such time as the NAV is
available to all market participants.
Suitability
    Currently, Exchange Rule 3.7 governs Recommendations to Customers
(Suitability). Prior to the commencement of trading of any inverse,
leveraged, or inverse leveraged securities, the Exchange will inform
its Members of the suitability requirements of the Exchange Rule 3.7 in
an Information Circular. Specifically, Members will be reminded in the
Information Circular that, in recommending transactions in these
securities, they must have a reasonable basis to believe that (1) the
recommendation is suitable for a customer given reasonable inquiry
concerning the customer's investment objectives, financial situation,
needs, and any other information known by such Member, and (2) the
customer can evaluate the special characteristics, and is able to bear
the financial risks, of an investment in the securities. In connection
with the suitability obligation, the Information Circular will also
provide that Members must make reasonable efforts to obtain the
following information: (1) The customer's financial status; (2) the
customer's tax status; (3) the customer's investment objectives; and
(4) such other information used or considered to be reasonable by such
Member or registered representative in making recommendations to the
customer.
    In addition, FINRA has implemented increased sales practice and
customer margin requirements for FINRA members applicable to inverse,
leveraged, and inverse leveraged securities and options on such
securities, as described in FINRA Regulatory Notices 09-31 (June 2009),
09-53 (August 2009) and 09-65 (November 2009) (``FINRA Regulatory
Notices''). Members that carry customer accounts will be required to
follow the FINRA guidance set forth in the FINRA Regulatory Notices.
The Information Circular will reference the FINRA Regulatory Notices
regarding sales practice and customer margin requirements for FINRA
members applicable to inverse, leveraged, and inverse leveraged
securities and options on such securities.
    The Exchange notes that, for such inverse, leveraged, and inverse
leveraged securities, the corresponding funds seek leveraged, inverse,
or leveraged inverse returns on a daily basis, and do not seek to
achieve their stated investment objective over a period of time greater
than one day because compounding prevents the funds from perfectly
achieving such results. Accordingly, results over periods of time
greater than one day typically will not be a leveraged multiple
(+200%), the inverse (-100%), or a leveraged inverse multiple (-200%)
of the period return of the applicable benchmark and may differ
significantly from these multiples. The Exchange's Information
Circular, as well as the applicable registration statement, will
provide information regarding the suitability of an investment in such
securities.
2. Statutory Basis
    The rule change proposed in this submission is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\17\ Specifically, the
proposed change is consistent with Section 6(b)(5) of the Act,\18\
because 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, and to remove impediments to, and perfect
the mechanism of, a free and open market and a national market system.
The Exchange believes that the proposed rules will facilitate the
listing and trading of additional types of exchange-traded products on
the Exchange that will enhance competition among market participants,
to the benefit of investors and the marketplace. In addition, the
listing and trading criteria set forth in the proposed rules are
intended to protect investors and the public interest.
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    \17\ 15 U.S.C. 78f(b).
    \18\ 15 U.S.C. 78f(b)(5).
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    The Exchange's listing requirements as proposed herein are at least
as stringent as those of another national securities exchange and,
consequently, the proposed rule change is consistent with the
protection of investors and the public interest. Additionally, the
proposal is designed to prevent fraudulent and manipulative acts and
practices, as all of the proposed new products are subject to existing
Exchange trading rules, together with surveillance procedures,
suitability, and prospectus requirements, and requisite Exchange
approvals, all set forth above.
    The proposal is also designed to promote just and equitable
principles of trade by way of initial and continued listing standards
which, if not maintained, will result in the discontinuation of trading
in the affected products. These requirements, together with the
applicable Exchange equity trading rules (which apply to the proposed
products), ensure that no investor would have an unfair advantage over
another respecting the trading of the subject products. On the
contrary, all investors will have the same access to, and use of,
information concerning the specific products and trading in the
specific products, all to the benefit of public customers and the
marketplace as a whole.
    Furthermore, the proposal is designed to remove impediments to and
perfect the mechanism of a free and open market and a national market
system by adopting listing standards that will lead ultimately to the
trading of the proposed new products on the Exchange, just as they are
currently traded on other exchanges. The Exchange believes that
individuals and entities permitted to make markets on the Exchange in
the proposed new products should enhance competition within the
mechanism of a free and open market and a national market system, and
customers and other investors in the national market system should
benefit from more depth and liquidity in the market for the proposed
new products.

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

    The Exchange does not believe that the proposed rule change imposes
any burden on competition.

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 Changes and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i)

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BATS-2012-030 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BATS-2012-030. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549, on official business days between 10:00 a.m.
and 3:00 p.m. Copies of the filing will also be available for
inspection and copying at the Exchange's principal office. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-BATS-2012-030 and should be
submitted on or before August 29, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-19350 Filed 8-7-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Rules and Regulations]
[Pages 55807-55814]
[FR Doc No: 2011-22981]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0466; FRL-8882-1]

Novaluron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA) for residues of novaluron in or on
multiple commodities which are identified and discussed later in this
document. Additionally, the Agency is amending existing tolerances for
meat byproducts and revising commodity terms for hog and poultry
byproducts. Interregional Research Project Number 4 (IR-4) requested
the sweet corn tolerances; Makhteshim-Agan of North America, Inc.
requested the food and feed handling establishment tolerances.

DATES: This regulation is effective September 9, 2011. Objections and
requests for hearings must be received on or before November 8, 2011,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0466. 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: Jennifer Gaines, 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 site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the
harmonized test guidelines referenced in this document electronically,
please go http://www.epa.gov/ocspp and select ``Test Methods and
Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-0466 in the subject line on the first
page of your. All requests for a hearing must be in writing, and must
be received by the Hearing Clerk on or before November 8, 2011.
Addresses for mail and hand delivery of objections and hearing requests
are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number

EPA-HQ-OPP-2010-0466, 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. Summary of Petitioned-for Tolerance

    In the Federal Register of June 23, 2010 (75 FR 35801) (FRL-8831-
3), 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
0F7708) by Makhteshim-Agan of North America, Inc., 4515 Falls of Neuse
Road, Raleigh, NC 27609 as well as the filing of a pesticide petition
(PP 0E7723) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ
08540. The IR-4 petition (PP 0E7723) requested that 40 CFR 180.598 be
amended by establishing tolerances for residues of the insecticide
novaluron, (N -[[[3-chloro-4-[1,1,2-trifluoro-2-
(trifluoromethoxy)ethoxy] phenyl]amino] carbonyl]-2,6-
difluorobenzamide), in or on corn, sweet, kernels plus cob with husks
removed at 0.05 parts per million (ppm); corn, sweet, forage at 20 ppm;
and corn, sweet, stover at 50 ppm and to increase the established
livestock tolerances for residues of novaluron in or on milk from 1.0
to 1.5 ppm, and milk fat from 20 to 35 ppm, respectively. The
Makhteshim-Agan petition (PP 0F7708) requested novaluron tolerances for
all food commodities (other than those already covered by a higher
tolerance as a result of use on growing crops) in food handling
establishments where food products are held, processed or prepared at
0.01 ppm. That notice referenced a summary of the petitions prepared by
Makhteshim-Agan of North America, Inc, the registrant, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing for PP 0F7708.
Comments were received on the notice of filing for PP 0E7723. EPA's
response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
revised the tolerances for sweet corn forage and determined it is not
appropriate to raise the existing tolerances for milk and milk fat. The
EPA also determined it is appropriate to revise several existing
livestock commodities based on the proposed sweet corn use. 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 novaluron including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with novaluron
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.
    Novaluron has low acute toxicity via the oral, dermal, and
inhalation routes. No ocular or dermal irritation was noted. Novaluron
is not a dermal sensitizer. In subchronic and chronic toxicity studies,
novaluron primarily produced hematotoxic effects (toxicity to blood)
such as methemoglobinemia, decreased hemoglobin, decreased hematocrit,
and decreased red blood corpuscles (RBCs or erythrocytes) that were
associated with compensatory erythropoiesis. Increased spleen weights
and/or hemosiderosis in the spleen were considered to be due to
enhanced removal of damaged erythrocytes and not to an immunotoxic
effect.
    There was no maternal or developmental toxicity seen in the rat and
rabbit developmental toxicity studies up to the limit doses. In the
two-generation reproductive toxicity study in rats, both parental and
offspring toxicity (increased spleen weights) were observed at the same
dose. Reproductive toxicity (decreases in epididymal sperm counts and
increase age at preputial separation in the F1 generation) was observed
at a higher dose only in males.
    Signs of neurotoxicity were seen in the rat acute neurotoxicity
study at the limit dose, including clinical signs (piloerection, fast/
irregular breathing), functional observation battery (FOB) parameters
(head swaying, abnormal gait) and neuropathology (sciatic and tibial
nerve degeneration). However, no signs of neurotoxicity or
neuropathology were observed in the subchronic neurotoxicity study in
rats or in any other subchronic or chronic toxicity study in rats, mice
or dogs. Therefore, there is no concern for neurotoxicity resulting
from exposure to novaluron.
    There was no evidence of carcinogenic potential in either the rat
or mouse carcinogenicity studies and no evidence of mutagenic activity
in the submitted mutagenicity studies, including a bacterial
(Salmonella, E. coli) reverse mutation assay, an in vitro mammalian
chromosomal aberration assay, an in vivo mouse bone-marrow micronucleus
assay and a bacterial DNA damage or repair assay. Based on the results
of these studies, EPA has classified novaluron as ``not likely to be
carcinogenic to humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by novaluron 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 ``Novaluron: Human-Health Risk
Assessment for Proposed Section 3 Uses on Sweet Corn and in Food--or
Feed-Handling Establishments'' at pages 53-56 in docket ID number EPA-
HQ-OPP-2010-0466.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological
endpoints for novaluron used for human risk assessment is shown in
Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Novaluron for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                Point of departure and
       Exposure/scenario           uncertainty/safety   RfD, PAD, LOC for risk   Study and toxicological effects
                                        factors                assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All              Not applicable........  None..................  An endpoint of concern
 populations).                                                                   attributable to a single dose
                                                                                was not identified. An acute
                                                                                RfD was not established.
Chronic dietary (All            NOAEL = 1.1 mg/kg/day   Chronic RfD = cPAD =    Combined chronic toxicity/
 populations).                   UF = 100.               0.011 mg/kg/day.        carcinogenicity feeding in rat.
                                FQPA SF = 1x..........                           LOAEL = 30.6 mg/kg/day based on
                                                                                erythrocyte damage and turnover
                                                                                resulting in a regenerative
                                                                                anemia.
Dermal short-term (1 to 30      Not applicable........  None..................  No toxicity was observed at the
 days).                                                                          limit dose in the dermal study
                                                                                and there were no developmental
                                                                                toxicity concerns at the limit-
                                                                                dose; therefore, quantification
                                                                                of short-term dermal risk is
                                                                                not necessary.
Dermal intermediate-term (1 to  Oral study NOAEL =      Residential LOC for     90-day feeding study in rat.
 6 months).                      4.38 mg/kg/day          MOE < 100.              LOAEL = 8.64 mg/kg/day based on
                                 (dermal absorption                              clinical chemistry (decreased
                                 rate = 100)%.                                   hemoglobin, hematocrit, and RBC
                                                                                counts) and histopathology
                                                                                (increased hematopoieses and
                                                                                hemosiderosis in spleen and
                                                                                liver).
Inhalation short-term (1 to 30  Oral study NOAEL =      Residential/            90-day feeding study in rat.
 days).                          4.38 mg/kg/day          Occupational LOC for    LOAEL = 8.64 mg/kg/day based on
                                 (inhalation             MOE < 100.              clinical chemistry (decreased
                                 absorption rate =                               hemoglobin, hematocrit, and RBC
                                 100%).                                          counts) and histopathology
                                                                                (increased hematopoieses and
                                                                                hemosiderosis in spleen and
                                                                                liver).
Inhalation Intermediate-term    Oral study NOAEL = 1.1  Residential/            Combined chronic toxicity/
 (1 to 6 months).                mg/kg/day (inhalation   Occupational LOC for    carcinogenicity feeding in rat.
                                 absorption rate =       MOE < 100.              LOAEL = 30.6 mg/kg/day based on
                                 100%).                                          erythrocyte damage and turnover
                                                                                resulting in a regenerative
                                                                                anemia.
----------------------------------------------------------------------------------------------------------------
Cancer........................                      Not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
UF = Uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL = lowest-
  observed-adverse-effect-level, PAD = population-adjusted dose (a = acute, c = chronic), RfD = reference dose,
  MOE = margin of exposure, LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to novaluron, EPA considered exposure under the petitioned-for
tolerances as well as all existing novaluron tolerances in 40 CFR
180.598. EPA assessed dietary exposures from novaluron 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.
    No such effects were identified in the toxicological studies for
novaluron; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA from 1994-
1996 and 1998 Continuing Surveys of Food Intakes by Individuals
(CSFII). As to residue levels in food, EPA conducted a partially
refined dietary (food and drinking water) exposure and risk assessment
for the proposed new uses on sweet corn and in food--and feed--handling
establishments, all established uses, and drinking water using the
DEEM-FCID (Dietary Exposure Evaluation Model-Food Commodity Ingredient
Database), Version 2.03, which uses food consumption data from the USDA
1994-1996 and 1998 CSFII. As to residue levels in food, EPA
incorporated average percent crop treated (PCT) data for apples,
cabbage, cotton, pears, and potatoes, and utilized percent crop treated
for new use PCT estimates for grain sorghum and sweet corn. 100 PCT was
assumed for the remaining food commodities. Anticipated residues (ARs)
for meat, milk, hog, and poultry commodities were calculated using
average field trial residues, PCT estimates for sweet corn and grain
sorghum, average PCT for apple and cotton, and assumed 100 PCT for
sugarcane and cowpea seed.

    The chronic analysis also incorporated average greenhouse trial
residues for tomatoes; empirical processing factors for apple juice
(translated to pear and stone fruit juice), cottonseed oil, dried
plums, and tomato paste and puree; and DEEM default processing factors
for the remaining processed commodities; and average field trial
residues for all crops unless residues were less than LOQ (If residues
were less than LOQ, the chronic analysis assumed \1/2\ LOQ values)
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that novaluron does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
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.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows:
    Apples at 15%; cabbage at 10%; cotton at 2.5%; pears at 10%; and
potatoes at 2.5%.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency estimated the PCT for new uses as follows:
    Sweet corn at 59% and sorghum at 5%.
    EPA utilized estimated PCT data in the chronic dietary risk
assessment for the new use on sweet corn and sorghum, based on the
market leader approach. Sorghum, though not new, was only registered 1
year ago. Since sorghum has been registered for such a relatively short
period, EPA has sorghum to be a ``new use'' when estimating the PCT.
The market leader approach is the comparison of the PCT with all
chemicals of a specific type (i.e., herbicide, insecticide, etc.) on a
specific crop and choosing the highest PCT (market leader) as the PCT
for the new use. This method of estimating a PCT for a new use of a
registered pesticide or a new pesticide produces a high-end estimate
that is unlikely, in most cases, to be exceeded during the initial 5
years of actual use. The predominant factors that bear on whether the
estimated PCT could be exceeded are: The extent of the pest pressure on
the crops in question; the pest spectrum of the new pesticide in
comparison with the market leaders as well as whether the market
leaders are well-established for this use; and resistance concerns with
the market leaders.
    Novaluron has a relatively narrow spectrum of activity compared to
the market leaders. Additionally, there are no resistance or pest
pressure issues identified for the use of novaluron on sweet corn. All
information currently available has been considered for use on sweet
corn, and EPA concludes that it is unlikely that the actual sweet corn
PCT with novaluron will exceed the estimated PCT for new uses during
the next 5 years.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which novaluron may be applied in a particular area.
    2. Dietary exposure from drinking water. The residues of concern in
drinking water are novaluron and its chlorophenyl urea and
chloroaniline degradates. The Agency used screening level water
exposure models in the dietary exposure analysis and risk assessment
for novaluron in drinking water. These simulation models take into
account data on the physical, chemical, and fate/transport
characteristics of novaluron. 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.
    Estimated drinking water concentrations (EDWCs) were not generated
for the food-and-feed handling establishment uses because the use
pattern is not expected to result in the contamination of drinking
water. Based on the Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) for parent novaluron in surface water; and
the Screening Concentration in Ground Water (SCI-GROW) models for
novaluron, chlorophenyl urea and

chloroaniline in ground water, the EDWCs of novaluron, chlorophenyl
urea, and chloroaniline for chronic exposures for non-cancer
assessments are estimated to be 0.76 parts per billion (ppb), 0.89 ppb
and 2.6 ppb, respectively, for surface water and 0.0056 ppb, 0.0045 ppb
and 0.0090 ppb, respectively, for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. The highest drinking water
concentrations were estimated for surface water. Of the three EDWC
values for surface water, the chronic EDWC for the terminal metabolite
chloroaniline, is the highest (assuming 100% molar conversion from
parent to aniline). This is consistent with the expected degradation
pattern for novaluron. Therefore, for chronic dietary risk assessment,
the water concentration value for chloroaniline of 2.6 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). Novaluron is not
currently registered for any specific use patterns that would result in
residential exposure. However, the following uses that could result in
residential exposures are pending registration and have been assessed:
Indoor and outdoor uses for the control of roaches and crickets (crack
and crevice and spot treatments) in residential areas such as homes and
apartment buildings, and their immediate surroundings, and on modes of
transportation.
    There is a potential for exposure in residential settings during
the application process for homeowners who use products containing
novaluron. There is also a potential for exposure from entering
novaluron-treated areas that could lead to exposures to adults and
children. Both residential handler and post-application scenarios were
assessed for the indoor use since this is believed to cover the outdoor
perimeter treatment. Residential handler dermal and inhalation
exposures were assessed for application via low-pressure handwands and
trigger-pump sprayers.
    Additionally exposure routes were assessed for post-application
exposures for adults and children via inhalation and dermal routes and
post-application incidental oral (hand-to-mouth) exposure for children
(3 to < 6 years old). Additionally, a combined residential assessment
that consisted of adult dermal and inhalation post-application
exposures as well as children (3 to < 6 years old) dermal, inhalation,
and oral (hand-to-mouth) post-application exposure was included which
details of the residential risk exposure and risk assessment are
contained in the EPA public docket EPA-HQ-OPP-2010-0466 at http://www.regulations.gov in document ``Novaluron: Human-Health Risk
Assessment for Proposed Section 3 Uses on Sweet Corn and in Food- or
Feed-Handling Establishments'' on pp. 28-37.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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.''
    EPA has not found novaluron to share a common mechanism of toxicity
with any other substances, and novaluron does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that novaluron does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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 Safety
Factor (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 prenatal and postnatal
toxicology database for novaluron includes rat and rabbit prenatal
developmental toxicity studies and a 2-generation reproduction toxicity
study in rats. There was no evidence of increased quantitative or
qualitative susceptibility following in utero exposure to rats or
rabbits in the developmental toxicity studies and no evidence of
increased quantitative or qualitative susceptibility of offspring in
the reproduction study. Neither maternal nor developmental toxicity was
seen in the developmental studies up to the limit doses. In the
reproduction study, offspring and parental toxicity (increased absolute
and relative spleen weights) were similar and occurred at the same
dose; additionally, reproductive effects (decreases in epididymal sperm
counts and increased age at preputial separation in the F1 generation)
occurred at a higher dose than that which resulted in parental
toxicity.
    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 novaluron is complete except for
immunotoxicity testing and a 90-day inhalation toxicity study. Recent
changes to 40 CFR part 158 make immunotoxicity testing (OPPTS Guideline
870.7800) required for pesticide registration; however, the existing
data are sufficient for endpoint selection for exposure/risk assessment
scenarios, and for evaluation of the requirements under the FQPA.
Although effects were seen in the spleen in two studies, as explained
in Unit III.A., EPA has concluded that novaluron does not directly
target the immune system and the Agency does not believe that
conducting a functional immunotoxicity study will result in a NOAEL
lower than the regulatory dose for risk assessment; therefore, an
additional database uncertainty factor is not needed to account for
potential immunotoxicity. A 90-day inhalation toxicity study is
requested for further characterization of inhalation risk. Due to the
potential for repeated inhalation exposure anticipated from the
proposed residential use pattern, there is concern for toxicity by the
inhalation route. An inhalation study would provide a dose and endpoint
via the route of exposure of concern (i.e. route-specific study) and
thus would avoid using an oral study and route-to-route extrapolation.
Although a point of departure from an oral study was used to assess
residential post-application inhalation risks for novaluron, the Agency
does not believe this assessment is under-protective. The

post-application inhalation MOEs calculated were all greater than
3,000, thus providing an ample margin of safety to account for any
uncertainties in route-to-route extrapolation. Further, the MOE was
calculated for post-application inhalation exposure and risk using the
saturation concentration which is a very conservative approach. The
saturation concentration represents what would occur if a large amount
of chemical were spilled in a non-ventilated room and allowed to
evaporate until equilibrium is reached.
    ii. There were signs of neurotoxicity in the acute neurotoxicity
study in rats, including clinical signs (piloerection, irregular
breathing), functional observation battery (FOB) parameters (increased
head swaying, abnormal gait), and neuropathology (sciateic and tibial
nerve degeneration). However, the signs observed were not severe, were
seen only at the limit dose (2000 mg/kg/day) and were not reproducible.
No signs of neurotoxicity or neuropathology were observed in the
subchronic neurotoxicity study in rats at similar doses, and no
evidence of neuropathology was observed in subchronic and chronic
toxicity studies in rats, mice, or dogs. In addition, no clinical signs
were observed in the acute oral toxicity study (LD50 > 5,000 mg/kg).
Therefore, novaluron does not appear to be a neurotoxicant, and there
is no need for a developmental neurotoxicity study or additional UFs to
account for neurotoxicity.
    iii. There is no evidence that novaluron results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed using
anticipated residues derived from reliable residue field trials and PCT
assumptions for some commodities. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to novaluron in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children
as well as incidental oral exposure of toddlers resulting from the
proposed residential uses of novaluron. These assessments will not
underestimate the exposure and risks posed by novaluron.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
novaluron is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
novaluron from food and water will utilize 72% of the cPAD for children
1 to 2 years old, the population group receiving the greatest exposure.
The residential exposure assessment was conducted using high-end
estimates of use and potential exposure providing a conservative,
health protective estimate of risk.
    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).
    There are potential short-term exposures from the pending
residential uses for novaluron. The Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to novaluron.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 1,600 for the
U.S. population and 290 for children 1-2 years old. Because EPA's level
of concern for novaluron is a MOE of 100 or below, these MOEs are not
of concern.
    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).
    There are potential intermediate-term exposures from the pending
residential uses for novaluron. The Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
intermediate-term residential exposures to novaluron.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 320 for U.S. population and 140 for children 1-2
years old. Because EPA's level of concern for novaluron is a MOE of 100
or below, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, novaluron is not expected to pose a cancer risk to humans.
    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 novaluron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The following adequate enforcement methodologies (gas
chromatography/electron-capture detection (GC/ECD) method and a high-
performance liquid chromatography/ultraviolet (HPLC/UV) method) are
available to enforce the tolerance expression. The 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

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs) established for residues of novaluron in or on sweet corn,
stover,

forage and kernel plus cob with husks removed or for all food
commodities based on the use of novaluron in food and feed handling
establishments. Canada is currently in the process of reviewing the use
of novaluron on sweet corn. The EPA and the Pest Management Regulatory
Agency (PMRA) reviewed the sweet corn petition as a Joint Review
Project and tolerance recommendations are in agreement at 0.05 ppm for
sweet corn and kernel plus cob with husks removed. Additionally, PMRA
proposed to increase its MRL for milk to 1.0 ppm from 0.5 ppm, and as a
result the EPA and PMRA milk tolerances/MRLs will be in agreement. The
PMRA does not recommend MRLs for livestock feed commodities and
therefore will not establish MRLs for sweet corn stover and sweet corn
forage.

C. Response to Comments

    EPA received one comment to the Notice of Filing that made a
general objection to the presence of any novaluron residues on
vegetable crops. The Agency understands the commenter's concerns and
recognizes that some individuals believe that pesticides should be
banned on agricultural crops. However, the existing legal framework
provided by section 408 of the Federal Food, Drug and Cosmetic Act
(FFDCA) states that tolerances may be set when persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute. This citizen's comment appears
to be directed at the underlying statute and not EPA's implementation
of it; the citizen has made no contention that EPA has acted in
violation of the statutory framework. The commenter also expressed
concern that EPA's risk assessment for novaluron did no ``combined
testing'' with other chemicals. EPA, however, does not require
``combined testing'' of a pesticide with other pesticides or other
chemicals due to impracticality. With regard to the potential for
cumulative effects from exposure to the pesticide and other substances
with a common mechanism of toxicity, see the discussion of this issue
in Unit III.C.4., Cumulative effects from substances with a common
mechanism of toxicity.

D. Revisions to Petitioned-for Tolerances

    Based on analysis of the residue field trial data using the
Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance
for Setting Pesticide Tolerances Based on Field Trial Data, EPA revised
the proposed tolerance on corn, sweet, forage from 20 ppm to 16 ppm and
determined no change to the existing milk and milk fat tolerances is
needed.
    Based on the proposed use on sweet corn, the revised reasonably
balanced dietary burdens (RBDBs) for novaluron are 9.6 ppm for beef
cattle, 18.3 ppm for dairy cattle, 2.4 ppm for poultry, and 2.5 ppm for
swine. Accordingly, the Agency has determined it is appropriate to
raise the existing tolerances for meat byproducts. However, no changes
are necessary for the tolerances for secondary residues in/on cattle,
goat, horse, sheep, poultry, and swine commodities. Additionally,
commodity terms for hog, meat byproducts and poultry, meat byproducts
are being revised.
    Therefore, the tolerances for meat byproducts are being revised as
follows: Cattle, meat byproducts, except kidney and liver from 0.60 ppm
to 11 ppm; goat, meat byproducts, except kidney and liver from 0.60 ppm
to 11 ppm; horse, meat byproducts, except kidney and liver from 0.60
ppm to 11 ppm; sheep, meat byproducts, except kidney and liver from
0.60 ppm to 11 ppm; hog, meat byproducts from 0.10 ppm to hog, meat
byproducts, except kidney and liver to 1.5 ppm; and poultry, meat
byproducts from 0.80 ppm to poultry, meat byproducts, except kidney and
liver to 7.0 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of novaluron,
(N-[[[3-chloro-4-[1,1,2-trifluoro-2- (trifluoromethoxy)ethoxy]
phenyl]amino]carbonyl]-2,6-difluorobenzamide), in or on corn, sweet,
kernels plus cob with husks removed at 0.05 ppm; corn, sweet, forage at
16 ppm; corn, sweet, stover at 50 ppm; cattle, meat byproducts, except
kidney and liver at 11 ppm; goat, meat byproducts, except kidney and
liver at 11 ppm; horse, meat byproducts, except kidney and liver at 11
ppm; sheep, meat byproducts, except kidney and liver at 11 ppm; hog,
meat byproducts, except kidney and liver at 1.5 ppm; poultry, meat
byproducts, except kidney and liver at 7.0 ppm; and Food/feed
commodities (other than those covered by a higher tolerance as a result
of use on growing crops) in food/feed handling establishments at 0.01
ppm.

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) (Pub. L. 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: August 26, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.598, paragraph (a), is amended as follows:
0
a. Revise the commodity entries for ``cattle, meat byproducts, except
kidney and liver''; ``goat, meat byproducts, except kidney and liver'';
``hog, meat byproducts''; ``horse, meat byproducts, except kidney and
liver''; ``poultry, meat byproducts''; ``sheep, meat byproducts, except
kidney and liver''; and
0
b. Add, alphabetically, the commodities for ``corn, sweet, forage'';
``corn, sweet, kernel plus cob with husks removed''; ``corn, sweet,
stover''; and ``food and feed commodities (other than those covered by
a higher tolerance as a result of use on growing crops) in food and
feed handling establishments.''
    The revised and added text reads as follows:

Sec.  180.598  Novaluron; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, meat byproducts, except kidney and liver...........        11

                                * * * * *
Corn, sweet, forage........................................        16
Corn, sweet, kernel plus cob with husks removed............         0.05
Corn, sweet, stover........................................        50

                                * * * * *
Food commodities and feed commodities (other than those             0.01
 covered by a higher tolerance as a result of use on
 growing crops) in food and feed handling establishments...

                                * * * * *
Goat, meat byproducts, except kidney and liver.............        11

                                * * * * *
Hog, meat byproducts, except kidney and liver..............         1.5

                                * * * * *
Horse, meat byproducts, except kidney and liver............        11

                                * * * * *
Poultry, meat byproducts, except kidney and liver..........         7.0

                                * * * * *
Sheep, meat byproducts, except kidney and liver............        11
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-22981 Filed 9-8-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 18 (Friday, January 29, 2021)]
[Notices]
[Page 7613]
[FR Doc No: 2021-01952]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2021-0011]

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System

    Under part 235 of title 49 Code of Federal Regulations (CFR) and 49
U.S.C. 20502(a), this document provides the public notice that on
January 14, 2021, Union Pacific Railroad Company (UP) petitioned the
Federal Railroad Administration (FRA) seeking approval to discontinue
or modify a signal system. FRA assigned the petition Docket Number FRA-
2021-0011.

    Applicant: Union Pacific Railroad Company, Gregory M. Richardson,
General Director--Train Control Systems, 1400 Douglas Street--MS 0480,
Omaha, NE 68179.
    Specifically, UP requests permission to discontinue all automatic
train control (ATC) and automatic cab signal (ACS) systems in service
on UP on a segment-by-segment basis, commensurate with progress on
completion of work to equip certain hand-operated switches in ATC/ACS
territories as described in a plan submitted to FRA in December 2019.
UP states that plan described the nature of the work and the safety
benefits provided, and it was acknowledged by FRA in June 2020. UP
explains a detailed schedule of this work is provided to FRA monthly
under separate correspondence, and the work is planned to be completed
during 2021.
    UP states the reason for discontinuance is that the operation of
positive train control (PTC) in conjunction with both the equipping of
non-electrically locked switches for PTC communication and the
promulgation of operating rules governing operations in the case of PTC
failures provide a level of safety exceeding that provided solely by
the use of ATC/ACS systems. Since 2017, pursuant to provisions of the
waiver in Docket Number FRA-2016-0108, UP has operated PTC in lieu of
ATC/ACS in certain territories. Due to that waiver, the existing ATC
and ACS systems have been largely unutilized for some time.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Ave. SE, W12-140, Washington, DC 20590.
     Hand Delivery: 1200 New Jersey Ave. SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by March 15, 2021 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2021-01952 Filed 1-28-21; 8:45 am]
BILLING CODE 4910-06-P