[Federal Register: February 12, 2007 (Volume 72, Number 28)]
[Notices]
[Page 6550]
[DOCID:fr12fe07-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-164-000]

Gas Transmission Northwest Corporation, Anadarko Petroleum
Corporation and Anadarko Energy Services Company; Notice of Joint
Petition for Expedited Grant of Limited Waivers

February 5, 2007.
    Take notice that on January 31, 2007, Gas Transmission Northwest
Corporation (GTN) and Anadarko Petroleum Corporation (APC) and Anadarko
Energy Services Company (AESC) (collectively with APC, Anadarko)
tendered for filing a Joint Petition for Expedited Grant of Limited
Waivers.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time February 12, 2007.

Magalie R. Salas,
Secretary.
[FR Doc. E7-2276 Filed 2-9-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 124 (Thursday, June 27, 2013)]
[Notices]
[Pages 38717-38718]
[FR Doc No: 2013-15332]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Cardiovascular and Renal Drugs Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Cardiovascular and Renal Drugs Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on August 6, 2013, from 8
a.m. to 4 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building

31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Kristina Toliver, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area).
    A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: On August 6, 2013, the committee will discuss new drug
application (NDA) 204819, proposed trade name ADEMPAS (riociguat coated
tablet), submitted by Bayer HealthCare Pharmaceuticals Inc., for the
treatment of: (1) Chronic thromboembolic pulmonary hypertension World
Health Organization (WHO) Group 4 to improve exercise capacity and WHO
functional class and (2) pulmonary arterial hypertension (WHO Group 1)
to improve exercise capacity, improve WHO functional class, and to
delay clinical worsening.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before July
22, 2013. Oral presentations from the public will be scheduled between
approximately 12:30 p.m. to 1:30 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before July 12, 2013. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by July 15, 2013.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kristina Toliver at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: June 21, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-15332 Filed 6-26-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 11 (Tuesday, January 19, 2021)]
[Notices]
[Pages 5300-5302]
[FR Doc No: 2021-00961]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34171; 812-15157]

Natixis ETF Trust II, et al.

January 12, 2021.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application to amend a prior order for exemptive
relief.

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Summary of Application:  Applicants request an order (``Amended
Order'') that would amend a prior order to permit the Funds, as defined
below, to use Creation Baskets (as defined below) that include
instruments that are not included, or are included with different
weightings, in the Fund's proxy portfolio.

Applicants:  Natixis Advisors, L.P. (``Natixis''), Natixis ETF Trust II
(the ``Trust'') and NYSE Group, Inc. (``NYSE'').

Filing Dates:  The application was filed on August 31, 2020, and
amended on November 16, 2020 and on December 8, 2020.

Hearing or Notification of Hearing:  An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by emailing the Commission's
Secretary at<EMAIL_ADDRESS>and serving Applicants with a
copy of the request by email. Hearing requests should be received by
the Commission by 5:30 p.m. on February 8, 2021 and should be
accompanied by proof of service on the Applicants, in the form of an
affidavit, or, for lawyers, a certificate of service. Pursuant to rule
0-5 under the Investment Company Act of 1940 (``Act''), hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by emailing to the
Commission's Secretary at<EMAIL_ADDRESS>
ADDRESSES: The Commission<EMAIL_ADDRESS>Applicants:
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Marc Mehrespand, Senior Counsel; Trace
Rakestraw, Branch Chief, at<PHONE_NUMBER> (Division of Investment
Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's website by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

I. Introduction

    1. On December 10, 2019, the Commission issued an order (``Prior
Order'') \1\ under section 6(c) of the Act for an exemption from
sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1
under the Act, under sections 6(c) and 17(b) of the Act for an
exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under
section 12(d)(1)(J) of the Act for an exemption from sections
12(d)(1)(A) and 12(d)(1)(B) of the Act.\2\ The Prior Order permitted
Applicants to introduce a novel type of actively-managed exchange-
traded fund (``ETF'') that is not required to disclose its portfolio
holdings on a daily basis (each, a ``Fund''). Rather, pursuant to the
Prior Order, each Business Day \3\ a Fund publishes a basket of
securities and cash that, while different from the Fund's portfolio, is
designed to closely track its daily performance (the ``Proxy
Portfolio'').
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    \1\ See Natixis ETF Trust II, et al., Investment Company Act
Release No. 33684 (Nov. 14, 2019) (notice) and Investment Company
Act Release No. 33711 (Dec. 10, 2019) (order). Except as
specifically noted in the application, all representations and
conditions contained in the application previously submitted with
the Commission (File No. 812-14870), as amended and restated, and
filed with the Commission on October 21, 2019 (the ``Prior
Application'') remain applicable to the operation of the Funds and
will apply to any Funds relying on the Amended Order.
    \2\ The relief granted in the Prior Order under section
12(d)(1)(J) of the Act for an exemption from sections 12(d)(1)(A)
and 12(d)(1)(B) of the 1940 Act (the ``Section 12(d)(1) Relief''),
and relief under sections 6(c) and 17(b) of the Act for an exemption
from sections 17(a)(1) and 17(a)(2) of the Act relating to the
Section 12(d)(1) Relief, will expire one year from the effective
date of rule 12d1-4. See Fund of Funds Arrangements, Investment
Company Act Rel. No. 10871 (Oct. 7, 2020), at III.
    \3\ All capitalized terms not otherwise defined in this notice
have the meanings ascribed to them in the Prior Application.
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    2. Pursuant to the Prior Order, a Fund sells and redeems its shares
(``Shares'') only in Creation Units and generally on an in-kind basis.
Purchasers are required to purchase Creation Units by making a deposit
of Deposit Instruments and shareholders redeeming their Shares receive
a transfer of Redemption Instruments.\4\ Under the Prior Order, the
names and quantities of the instruments that constitute the Deposit
Instruments and the Redemption Instruments for a Fund (collectively,
the ``Creation Basket'') are the same as the Fund's Proxy Portfolio,
except to the extent purchases and redemptions are made entirely or in
part on a cash basis.
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    \4\ Deposit Instruments and Redemption Instruments may include
cash and/or securities.
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    3. Applicants now seek to amend the Prior Order to, in effect, give
the Funds the same flexibility with respect to Creation Basket
composition as afforded to ETFs relying on rule 6c-11.\5\ More

specifically, Applicants have requested that the Funds be allowed to
use Creation Baskets that include instruments that are not included, or
are included with different weightings, in the Fund's Proxy Portfolio.
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    \5\ The Funds are not be able to operate in reliance on rule 6c-
11 because they do not disclose their portfolio holdings on a daily
basis as required by the rule. See rule 6c-11(c)(1)(i) (requiring an
ETF to disclose prominently on its website, publicly available and
free of charge, the portfolio holdings that will form the basis for
each calculation of NAV per share).
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II. The Application

A. Applicants' Proposal

    4. Upon amending the Prior Order, the names and quantities of the
instruments that may constitute a Creation Basket will generally be the
same as the Fund's Proxy Portfolio, but a Fund may accept Creation
Baskets that differ from the Proxy Portfolio. Each Business Day, before
the open of trading on the Exchange where a Fund is listed, the Fund
will publish on its website the composition of any Creation Basket
exchanged with an authorized participant on the previous Business Day
that differed from such Business Day's Proxy Portfolio other than with
respect to cash.
    5. Applicants represent that, for portfolio management or other
reasons, the Funds may determine that it is desirable to use Creation
Baskets that differ from the Proxy Portfolio (beyond cash
substitutions). For example, a Fund may want to use a Creation Basket
that contains instruments that are not included in a Fund's Proxy
Portfolio if the Adviser or Sub-Adviser seeks to add an instrument to
the Fund's Actual Portfolio) without incurring transaction costs
associated with the purchase of the instrument for cash. Similarly, if
the Adviser or Sub-Adviser decides to sell an instrument from a Fund's
Actual Portfolio, the instrument may be included in a Creation Basket
with the expectation that the Fund will deliver it in-kind during a
redemption transaction.
    6. The Funds will use the requested basket flexibility only in
circumstances under which Applicants believe there will be no harm to
the Funds or their shareholders, and in order to benefit the Funds and
their shareholders by reducing costs, increasing efficiency and
improving trading.
    7. Pursuant to condition 10 herein, each Fund will adopt and
implement written policies and procedures regarding the construction of
its Creation Baskets in accordance with rule 6c-11 under the Act. For
purposes of the requirement to comply with the policies and procedures
provision in rule 6c-11, only Creation Baskets that differ from a
Fund's Proxy Portfolio will be treated as a ``custom basket'' under
rule 6c-11(c)(3).
    8. Furthermore, pursuant to condition 9 herein, each Fund will
comply with the recordkeeping requirements of rule 6c-11.\6\ For
purposes of the requirement to comply with the recordkeeping provision
in rule 6c-11, only Creation Baskets different from a Fund's Proxy
Portfolio will be treated as a ``custom basket'' under rule 6c-
11(d)(2)(ii).
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    \6\ Pursuant to condition 9, each Fund will also maintain and
preserve a copy of the Proxy Portfolio published on the Fund's
website for each Business Day and a copy of each Creation Basket
made available.
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B. Considerations Relating to the Requested Relief

    9. Applicants represent that the ability to utilize a Creation
Basket that includes instruments that are not included, or are included
with different weightings, in a Fund's Proxy Portfolio, or are included
in different weightings, does not raise any new policy concerns about
reverse engineering of a Fund's portfolio, self-dealing or
overreaching, or selective disclosure beyond those concerns addressed
in connection with the Prior Order.
    10. Reverse Engineering. Applicants acknowledge that, by using a
Creation Basket that includes instruments that are not included in a
Fund's Proxy Portfolio, or are included in different percentages, and
by publishing such Creation Basket on its website, the Fund would
provide market participants with additional information about which
instruments it adds or removes from the Fund's Actual Portfolio.
However, Applicants represent that they will operate the Funds in a
manner designed to minimize the risk of reverse engineering and, for
the reasons set forth in the application, believe successful front-
running or free-riding is highly unlikely.
    11. Self-Dealing or Overreaching. Applicants state that authorized
participants and other market participants will not have the ability to
disadvantage the Funds by manipulating or influencing the composition
of Creation Baskets, including those that differ from the Proxy
Portfolio. Like the basket and custom basket policies and procedures
required of ETFs by rule 6c-11, the Funds will adopt and implement
written policies and procedures that govern the construction of
Creation Baskets and the process that will be used for the acceptance
of Creation Baskets to safeguard the best interests of the Funds and
their shareholders.\7\
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    \7\ See Exchange-Traded Funds, Investment Company Act Release
No. 33646 (Sept. 25, 2019) (``ETF Adopting Release''), at 80-94
(discussion of rule 6c-11 requirement for ETF policies and
procedures concerning basket construction and acceptance and
heightened policies and procedures for custom baskets).
---------------------------------------------------------------------------

    12. Selective Disclosure. The Funds and each person acting on
behalf of the Funds will continue to be required to comply with
Regulation Fair Disclosure as if it applied to them (except that the
exemptions provided in rule 100(b)(2)(iii) therein shall not apply).
Applicants believe that the new Creation Basket flexibility being
sought by the Applicants does not raise any new concerns about
selective disclosure of non-public material information. First, a
Fund's use of, or conversations with authorized participants about,
Creation Baskets that would result in such disclosure would effectively
be limited by the Funds' obligation to comply with Regulation Fair
Disclosure. Second, as noted above, each Business Day, before the open
of trading on the Exchange where a Fund is listed, the Fund will
publish on its website the composition of any basket accepted by the
Fund on the previous Business Day that differed from such Business
Day's Proxy Portfolio other than with respect to cash.

III. Requested Exemptive Relief

    For the reasons stated above, Applicants believe that the Prior
Order, as amended, continues to meet the relevant standards for relief
pursuant to section 6(c) of the Act for an exemption from sections
2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1 under the
Act, and under sections 6(c) and 17(b) of the Act for an exemption from
sections 17(a)(1) and 17(a)(2) of the Act, and under section
12(d)(1)(J) of the Act for an exemption from sections 12(d)(1)(A) and
12(d)(1)(B) of the Act.\8\
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    \8\ See supra note 2.
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IV. Applicants' Conditions

    Applicants agree that the Amended Order granting the requested
relief will be subject to all of the conditions in the Prior Order,
except that condition 9 of the Prior Order is deleted in its entirety
and replaced with the conditions 9-10 as follows:
    9. Each Fund will comply with the recordkeeping requirements of
rule 6c-11 under the Act, as amended, except that for purposes of this
condition, only Creation Baskets different from the Fund's Proxy
Portfolio will be treated as a ``custom basket'' under rule 6c-
11(d)(2)(ii). In addition, each Fund will maintain and preserve, for a
period of not less than five years, in an easily accessible place, (i)
a copy of the Proxy Portfolio published on the Fund's website for each
Business Day; and (ii) a copy of each Creation Basket made available.

    10. Each Fund will adopt and implement written policies and
procedures that govern the construction of Creation Baskets, as
required under rule 6c-11(c)(3) under the Act, as amended, except that
for purposes of this condition, only Creation Baskets different from
the Fund's Proxy Portfolio will be treated as a ``Custom Basket''. The
Fund's basket policies and procedures will be covered by the Fund's
compliance program and other requirements under rule 38a-1 under the
Act, as amended.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-00961 Filed 1-15-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: March 17, 2008 (Volume 73, Number 52)]
[Notices]
[Page 14282-14284]
[DOCID:fr17mr08-105]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57449; File No. SR-Amex-2008-13]

Self-Regulatory Organizations; American Stock Exchange, LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Rules Pertaining to the Terms of Index Option Contracts

March 7, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on February 19, 2008, American Stock Exchange, LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared substantially by Amex. Amex
filed the proposed rule change as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6) thereunder,\4\ which renders it effective upon filing with the
Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Amex proposes to add new Commentary .05 to Rule 903C to allow the
listing of up to seven expiration months for options on certain broad-
based indexes.
    The text of the proposed rule change is available at http://
www.amex.com, the principal office of Amex, and the Commission's Public
Reference Room.

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

    In its filing with the Commission, Amex included statements
concerning the purpose of and basis for the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. Amex has prepared summaries, set forth in Sections A, B,
and C below, of the most significant aspects of such statements.

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

1. Purpose
    The Exchange proposes to add new Commentary .05 to Amex Rule 903C
(Series of Stock Index Options) to allow the Exchange to list up to
seven (7) expiration months for index options based on broad-based
securities indexes (including reduced-value and jumbo) upon which a
constant three-month volatility index is calculated. Currently,
subparagraphs (i) and (ii) to Rule 903C(a) permit the Exchange to list
only six (6) expiration months in any stock index option at any one
time.
    Volatility products offer investors a unique set of tools for
hedging. For example, the Chicago Board Options Exchange, Incorporated
(``CBOE'') Volatility Index (``VIX'') options, first introduced in
February 2006, have proven to be one of CBOE's most successful new
products ever listed, currently averaging over 90,000 contracts traded
per day. In a recent proposal, CBOE explained that it plans to
introduce new volatility products and new volatility indexes in the
near future, including the CBOE S&P 500 Three-Month Volatility Index
(``VXV'').\5\ Similar to the VIX, the VXV is a measure of S&P 500
implied volatility, the volatility implied by S&P option prices.
Instead of reflecting a constant one-month implied volatility period,
however, VXV is designed to reflect the implied volatility of an option
with a constant three months to expiration. Since there is only one day
on which an option has exactly three months to expiration, VXV is
calculated as a weighted average of options expiring immediately before
and immediately after the three-month standard. Accordingly, an index
calculator would need to use four consecutive expiration months in
order to calculate a constant three-month volatility index.\6\
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    \5\ CBOE calculates volatility indexes on other broad-based
security indexes, such as the Dow Jones Industrial Average index
(``DJX''), the Nasdaq-100 index (``NDX''), and the Russell 2000
index (``RUT''). CBOE may calculate a constant three-month
volatility index on DJX, NDX, or RUT in the future. See Securities
Exchange Act Release No. 56821 (November 20, 2007), 72 FR 66210
(November 27, 2007) (SR-CBOE-2007-82) (``CBOE Proposal'').
    \6\ See Id. In CBOE Proposal, CBOE provides examples
illustrating the need for a seventh month in order to maintain four
consecutive near term contract months.
---------------------------------------------------------------------------

    Under the current application of subparagraphs (i) and (ii) of Amex
Rule 903C(a), the Exchange generally lists three consecutive near term
months and three months on a quarterly expiration cycle. One of the
three consecutive near term months is always a quarterly month;
however, that near term contract month (which is also a quarterly
month) is not included as part of the three months listed on a
quarterly expiration cycle. Therefore, in order to permit the addition
of four consecutive near term months under Rule 903C(a), the Exchange
would only be able to list two months on a quarterly expiration cycle.
Because of customer demand and other investment strategy reasons for
having three months on a quarterly expiration cycle, the Exchange is
seeking to increase, from six to seven, the number of expiration months
for broad-based security index options upon which a constant three-
month volatility index is calculated.
    Proposed Commentary .05 to Rule 903C will permit the Exchange to
list up to seven expiration months at any one time for any broad-based
security index option contract \7\ upon which any exchange calculates a
constant three-month volatility index. As a result, the Exchange, eight
times a year, would be able to add an additional seventh expiration
month in order to

maintain four consecutive near term contract months.
---------------------------------------------------------------------------

    \7\ See Amex Rule 900C(b)(1). Examples of such broad-based
securities indexes include the S&P 500, DJX, NDX and RUT.
---------------------------------------------------------------------------

    The Exchange believes that this proposal is necessary for
competitive reasons based on the fact that the CBOE, International
Securities Exchange, LLC, and NYSE Arca, Inc. all have the ability to
list up to seven expiration months for broad-based securities indexes
on which a constant three-month volatility index is calculated.\8\ This
proposal will similarly permit the Amex to accommodate the listing of a
fourth consecutive near term expiration month and maintain the listing
of three months on a quarterly expiration cycle, by increasing, from
six to seven, the number of expiration months for broad-based
securities indexes on which a constant three-month volatility index is
calculated.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release Nos. 56821 (November 20,
2007), 72 FR 66210 (November 27, 2007) (SR-CBOE-2007-82); 57104
(January 4, 2008), 73 FR 2070 (January 11, 2008) (SR-ISE-2007-113);
57284 (February 7, 2008), 73 FR 8387 (February 13, 2008) (SR-
NYSEArca-2008-16).
---------------------------------------------------------------------------

    The Amex has analyzed its capacity and represents that it believes
the Exchange and the Options Price Reporting Authority (OPRA) have the
necessary systems capacity to handle any additional quote and message
traffic associated with the additional listing of a seventh contract
month in order to maintain four consecutive near term contract months
for those broad-based securities index options upon which a constant
three-month volatility index is calculated.
2. Statutory Basis
    The Exchange believes the rule proposal is consistent with Section
6 of the Act,\9\ in general, and with Sections (b)(5) of the Act,\10\
in particular, because the proposed increase in the number of options
contract expiration month series is limited to broad-based securities
indexes upon which a constant three-month volatility index is
calculated and because the additional quote and message traffic from
any additional index option series is not expected to significantly
impact current system capacity. In addition, the Exchange believes
proposed rule change is consistent with the provisions of Section 6 of
the Act,\11\ in general, and with (b)(5) of the Act,\12\ in particular,
in that the proposal is designed to prevent fraudulent and manipulative
acts and practices, to promote just and equitable principles of trade,
to foster cooperation and coordination with persons engaged in
regulating, clearing, settling, processing information with respect to,
and facilitating transactions in securities, to remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(5).
    \11\ 15 U.S.C. 78f.
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6) thereunder.\14\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under 19b-4(f)(6) may not become
operative prior to 30 days after the date of filing, unless the
Commission designates a shorter time if such action is consistent with
the protection of investors and the public interest.\15\ The Exchange
has requested that the Commission waive the 30-day operative delay. The
Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest.
The Commission notes that other self-regulatory organizations recently
adopted substantially similar rule changes that were effective upon
filing,\16\ and that this filing raises no new regulatory issues.
---------------------------------------------------------------------------

    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
Amex has complied with this requirement.
    \16\ See Securities Exchange Act Release Nos. 57284 (February 7,
2008), 73 FR 8387 (February 13, 2008) (SR-NYSEArca-2008-16) and
57104 (January 4, 2008), 73 FR 2070 (January 11, 2008) (SR-ISE-2007-
113).
---------------------------------------------------------------------------

    The Commission notes the Exchange's representations that it
possesses the necessary systems capacity to handle the additional
traffic associated with the additional listing of a seventh contract
month in order to maintain four consecutive near term contract months
for those broad-based security index options upon which the Exchange
calculates a constant three-month volatility index. The Commission
hereby grants the Exchange's request and designates the proposal as
operative upon filing.\17\
---------------------------------------------------------------------------

    \17\ For purposes only of waiving the 30-day operative delay of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-Amex-2008-13 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Amex-2008-13. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the

proposed rule change between the Commission and any person, other than
those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, on official business
days between the hours of 10 a.m. and 3 p.m. Copies of such filing also
will be available for inspection and copying at the principal office of
Amex. 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-
Amex-2008-13 and should be submitted on or before April 7, 2008.
    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-5240 Filed 3-14-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 212 (Monday, November 2, 2020)]
[Notices]
[Pages 69326-69327]
[FR Doc No: 2020-24163]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R07-SFUND-2020-0540 FRL-10016-20-Region 8]

CERCLA Prospective Purchaser Administrative Settlement Agreement
and Covenant Not To Sue, Lockwood Solvent Ground Water Plume Superfund
Site, Billings, Montana

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for public comment.

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

SUMMARY: In accordance with the requirements of the Comprehensive
Environmental Response, Compensation, and Liability Act of 1980, as
amended (``CERLCA'') notice is hereby given by the U.S. Environmental
Protection Agency (EPA), Region 8, of a proposed prospective purchaser
administrative settlement agreement, embodied in an Administrative
Settlement Agreement and Covenant Not to Sue (``Settlement Agreement'')
with the State of Montana (the ``State''), MAC LTT, LLC (``MAC''),
which is purchasing the Property, and MAC LTT Manufacturing, Inc., a
related entity to MAC, which, although not purchasing the Property, has
leased the Property since 2013 and will continue to lease and operate
the Property after MAC purchases the Property (``Lessee,'' and with MAC
collectively, ``Purchaser''). This Settlement Agreement pertains to a
portion of the approximately 580-acre area known as the Lockwood
Solvent Ground Water Plume Superfund Site (``Site'') located at 1430
U.S. Highway 87 East, Billings, Montana (``The Property'').

DATES: Comments must be submitted on or before December 2, 2020.

ADDRESSES: The proposed Settlement Agreement and additional background
information relating to the agreement will be available for public
inspection at the EPA Superfund Record Center, 1595 Wynkoop Street,
Denver, Colorado, by appointment. Comments and requests for a copy of
the proposed agreement should be addressed to Julie Nicholson,
Enforcement Specialist, Superfund and Emergency Management Division,
Environmental Protection Agency-Region 8, Mail Code 8SEM-PAC, 1595
Wynkoop Street, Denver, Colorado 80202,<PHONE_NUMBER> and should
reference the Lockwood Solvent Ground Water Plume Site.
    You may also send comments, identified by Docket ID No. EPA-R07-
SFUND-2020-0540 to http://

www.regulations.gov. Follow the online instructions for submitting
comments.

FOR FURTHER INFORMATION CONTACT: Mark Chalfant, Senior Assistant
Regional Counsel, Office of Regional Counsel, Environmental Protection
Agency, Region 8, Mail Code 8ORC-LEC, 1595 Wynkoop, Denver, Colorado
80202,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Written Comments: Submit your comments,
identified by Docket ID No. EPA-R07-SFUND-2020-0540 at http://www.regulations.gov. Once submitted, comments cannot be edited or
removed from Regulations.gov. The EPA may publish any comment received
to its public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. If CBI exists,
please contact Mr. Bruce Morrison. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e., on the web, cloud, or other file sharing system). For
additional submission methods, the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    Notice is hereby given by the U.S. Environmental Protection Agency,
Region 8, of a proposed prospective purchaser settlement agreement,
embodied in an Administrative Settlement Agreement and Covenant Not to
Sue, with the State of Montana, MAC LTT, LLC, which is purchasing the
Property, and MAC LTT Manufacturing, Inc., a related entity to MAC,
which, although not purchasing the Property, has leased the Property
since 2013 and will continue to lease and operate the Property after
MAC purchases the Property. This Settlement Agreement pertains to a
portion of the approximately 580-acre area known as the Lockwood
Solvent Ground Water Plume Superfund Site located at 1430 U.S. Highway
87 East, Billings, Montana. Neither of the MAC-related business
entities is responsible for the original contamination at the Site.
Under the proposed Settlement Agreement, both MAC LTT, LLC and MAC LTT
Manufacturing, Inc. would be required to comply with standard CERCLA
bona fide prospective purchaser continuing obligations, including
access, appropriate care, and non-interference with the CERCLA remedy.
The proposed Settlement Agreement provides for the payment of certain
response costs incurred by the EPA and the State of Montana at or in
connection with the Site. The proposed Settlement Agreement includes a
covenant by the United States and the State of Montana not to sue or
take administrative action against MAC LTT, LLC and MAC LTT
Manufacturing, Inc., pursuant to sections 106 and 107(a) of CERCLA for
Existing Contamination, as that term is defined in the proposed
Settlement Agreement, and for payment of response costs. For thirty
(30) days following the date of publication of this document, the EPA
will receive written comments relating to the settlement. The EPA will
consider all comments received and may modify or withdraws its consent
to the Settlement Agreement if comments received disclose facts or
considerations that indicate that the proposed settlement is
inappropriate, improper, or inadequate. The EPA's response to any
comments received will be available for public inspection at EPA Region
8, 1595 Wynkoop Street, Denver, Colorado 80202.

Betsy Smidinger,
Division Director, Superfund and Emergency Management Division, Region
8.
[FR Doc. 2020-24163 Filed 10-30-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 103 (Friday, May 27, 2022)]
[Notices]
[Pages 32159-32160]
[FR Doc No: 2022-11443]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD21-15-000]

Joint Federal-State Task Force on Electric Transmission; Notice
Announcing Meeting and Inviting Agenda Topics

    On June 17, 2021, the Commission established a Joint Federal-State
Task Force on Electric Transmission (Task Force) to formally explore
transmission-related topics outlined in the Commission's order.\1\ The
Commission stated that the Task Force will convene for multiple formal
meetings annually, which will be open to the public for listening and
observing and on the record.\2\ The next public meeting of the Task
Force will be held on July 20, 2022, at the Sheraton San Diego Hotel
and Marina in San Diego, California, from approximately 1:00 p.m. to
5:30 p.m. Pacific time. Commissioners may attend and participate in
this meeting.
---------------------------------------------------------------------------

    \1\ Joint Fed.-State Task Force on Elec. Transmission, 175 FERC
] 61,224 (2021) (Establishing Order).
    \2\ Id. P 4.
---------------------------------------------------------------------------

    The meeting will be open to the public for listening and observing
and on the record. There is no fee for attendance and registration is
not

required. The public may attend in person or via Webcast.\3\ This
conference will be transcribed. Transcripts will be available for a fee
from Ace Reporting,<PHONE_NUMBER>.
---------------------------------------------------------------------------

    \3\ A link to the Webcast will be available on the day of the
event at https://www.ferc.gov/TFSOET.
_____________________________________-

    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to [email protected] or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER> with
the required accommodations.
    As explained in the Establishing Order, the Commission will issue
agendas for each meeting of the Task Force, after consulting with all
Task Force members and considering suggestions from state
commissions.\4\ The Establishing Order set forth a broad array of
transmission-related topics that the Task Force has the authority to
examine with a focus on topics related to planning and paying for
transmission, including transmission to facilitate generator
interconnection, that provides benefits from a federal and state
perspective.\5\ All interested persons, including all state
commissioners, are hereby invited to file comments in this docket
suggesting agenda items relating to this topic by June 6, 2022. The
Task Force members will consider the suggested agenda items in
developing the agenda for the July 20, 2022 public meeting. The agenda
will be issued in the above-captioned docket no later than July 6,
2022, for the meeting to be held on July 20, 2022.
---------------------------------------------------------------------------

    \4\ Establishing Order, 175 FERC ] 61,224 at PP 4, 7.
    \5\ Id. P 6.
---------------------------------------------------------------------------

    Comments may be filed electronically via the internet.\6\
Instructions are available on the Commission's website, https://www.ferc.gov/ferc-online/overview. For assistance, please contact FERC
Online Support at [email protected] or toll free at 1-866-208-
3676, or for TTY,<PHONE_NUMBER>. Although the Commission strongly
encourages electronic filing, documents may also be paper-filed. To
paper-file, submissions sent via the U.S. Postal Service must be
addressed to: Federal Energy Regulatory Commission, Office of the
Secretary, 888 First Street NE, Washington, DC 20426. Submissions sent
via any other carrier must be addressed to: Federal Energy Regulatory
Commission, Office of the Secretary, 12225 Wilkins Avenue, Rockville,
Maryland 20852.
---------------------------------------------------------------------------

    \6\ See 18 CFR 385.2001(a)(1)(iii) (2021).
---------------------------------------------------------------------------

    More information about the Task Force, including frequently asked
questions, is available here: https://www.ferc.gov/TFSOET. For more
information about this meeting, please contact: Gretchen Kershaw, 202-
502-8213, [email protected]; or Jennifer Murphy,<PHONE_NUMBER>,
[email protected]. For information related to logistics, please contact
Benjamin Williams,<PHONE_NUMBER>, [email protected]; or Rob
Thormeyer,<PHONE_NUMBER>, [email protected].

    Dated: May 23, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-11443 Filed 5-26-22; 8:45 am]
BILLING CODE 6717-01-P


<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  (7/1/2007) >

<EPA Registration Division contact: [insert name and telephone number with area code] >

<INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action. >

<TEMPLATE: >

<Bayer CropScience >

< [Insert petition number] >

<	EPA has received a pesticide petition ([insert petition number]) from Bayer CropScience, 800 N. Lindbergh Blvd., St. Loiuis, MO 63141 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180. >

< (Options (pick one) >

   <	1. by establishing tolerances and/or changing existing tolerances for residues of>

<	2. to establish an exemption from the requirement of a tolerance for>

<	[trifloxystrobin (benzeneacetic acid, (E,E)-α-(methoxyimino)-2-[[[[1-[3- (trifluoromethyl) phenyl]ethylidene]amino]oxy]methyl]-methyl ester) and the free form of its acid metabolite CGA - 321113 ((E,E)-methoxyimino-[2-[1-(3-trifluoromethyl-phenyl)-ethylideneaminooxymethyl]-phenyl]acetic acid)] in or on the raw agricultural commodity [Tropical and Subtropical, Small fruit, edible peel, Crop Subgroup 23A] at [0.2] parts per million; [Caneberry, Crop Subgroup 13-07A] at [3.0] parts per million; [Currant, black and red] at [4.0] parts per million; [Edible-poddded Legume Vegetables Crop Subgroup 6A] at [1.5] parts per million; [Succulent Shelled Pea and Bean Crop Subgroup 6B] at [0.15] parts per million; [Pea, Dry, Seed] at [0.2] parts per million and [Oil, olive, refined] at [0.5] parts per million.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

<A. Residue Chemistry>

<	1. Plant metabolism. The metabolism of trifloxystrobin in plants (cucumbers, apples, wheat, sugar beets and peanuts) is well understood. Identified metabolic pathways are substantially similar in plants and animals (goat, rat and hen). EPA has determined that trifloxystrobin parent and its metabolite CGA-321113 are the residue of concern for tolerance setting purposes. >

<	2. Analytical method. A practical analytical methodology for detecting and measuring levels of trifloxystrobin in or on raw agricultural commodities has been submitted. The limit of detection (LOD) for each analyte of this method is 0.08 ng injected, and the limit of quantitation (LOQ) is 0.02 ppm. The method is based on crop specific cleanup procedures and determination by gas chromatography with nitrogen-phosphorus detection.  A newer analytical method is available employing identical solvent mixtures and solvent to matrix ratio (as the first method), deuterated internal standards, and liquid chromatography/mass spectrometry-mass spectrometry (LC/MS-MS) with an electrospray interface, operated in the positive ion mode.  The LODs for trifloxystrobin range from 0.002 ppm to 0.01 ppm, depending on the crops, and the LOQ of each analyte is 0.01 ppm. >

<	3. Magnitude of residues.
Olive:

A total of eight field-residue trials (four harvest, four decline) were conducted in/on olives in Southern Europe (Portugal, Spain, Italy and Greece) following two foliar spray applications with Trifloxystrobin WG 50.

The treated plot in each trial received two foliar spray applications of Trifloxystrobin WG 50 at 60 g a.i./ha/application for a total target seasonal rate of 120 g a.i./ha.  The spray application interval ranged from 42 to 100 days.  The pre-harvest interval (PHI) in the harvest trials was 21 days.  In the decline trials, samples were collected at PHIs of -0, 0, 7, 14, 21 and 28 days.  Total trifloxystrobin residue (parent and acid metabolite) expressed as parent equivalents in olive collected 21 days after last application ranged from 0.03 to 0.11 ppm.

Olive is the representative commodity for Crop Subgroup 23A Tropical and Subtropical, Small fruit, edible peel, as such, Bayer is requesting that this European residue data in olives be used to establish an import tolerance of 0.2 ppm for Crop Subgroup 23A to facilitate trade from European countries.

Two olive processing trials were conducted in Spain and Greece.  For spray application the formulation Flint (50 WG) was used.  Flint 50 WG is a water dispersible granule formulation, containing 50 % Trifloxystrobin.  One foliar application was made at 0.060 - 0.072 kg active ingredient/ha.  A comparison of the residues in the raw agricultural commodity (RAC) with those in the processed fraction (refined oil) resulted in transfer factors of 4.8X and 3.5X with an average processing factor of 4.2X.  A review of the magnitude of residue studies with trifloxystrobin in olives shows the highest HAFT of 0.11 ppm was observed for olive.  Multiplying the olive HAFT (0.11 ppm) by the average refined oil processing factor (4.15X) gives 0.46 ppm.  Then rounding 0.46 ppm according the MRL Rounding Classes from the OECD MRL Calculator gives 0.5 ppm.

Raspberry:

A total of ten field-residue trials were conducted in/on raspberry fruit in Northern Europe (Belgium, Netherlands) or Southern Europe (France, Spain).  An additional four trials were conducted under greenhouse conditions in France.  The treatment regimen for all 14 trials was two foliar spray applications of a 500 SC formulation of Fluopyram (250 g/L) and Trifloxystrobin (250 g/L).  The two applications were made at 200 g trifloxystrobin/ha/application with a target 7-day spray interval and target 3-day PHI.  Total trifloxystrobin residue expressed as parent equivalents in field-grown olives collected 3 days after last application ranged from 0.228 to 1.441 ppm, while residues in raspberries grown under greenhouse conditions and collected 3 days after last application ranged from 0.103 to 0.525 ppm.  Using the OECD MRL calculator and total trifloxystrobin residues for field-grown raspberries collected at 3-day PHI, the calculated tolerance for raspberries would be 3.0 ppm.

Raspberry is the representative crop for Crop Subgroup 13-07A Caneberry, as such,  Bayer is requesting this European residue data in field-grown raspberries be used to establish an import tolerance for Crop Subgroup 13-07A of 3.0 ppm to facilitate trade from European countries.

Currant:

A total of ten field-residue trials were conducted in/on black or red currant in Northern Europe (Northern France, Belgium, Netherlands) or Southern Europe (France, Spain).  An additional six trials were conducted under greenhouse conditions in Italy, France and Spain.  The treatment regimen for all 16 trials was two foliar spray applications of a 500 SC formulation of Fluopyram (250 g/L) and Trifloxystrobin (250 g/L).  The two applications were made at 200 g trifloxystrobin/ha/application with a target 7-day spray interval and target 7-day PHI.  Total trifloxystrobin residue expressed as parent equivalents in field-grown current collected 7 days after last application ranged from 0.135 to 2.11 ppm, while residues in current grown under greenhouse conditions and collected 7 days after last application ranged from 0.16 to 0.37 ppm.  Using the OECD MRL calculator and total trifloxystrobin residues for field-grown current collected at 7-day PHI, the calculated tolerance for current would be 4.0 ppm.

Bayer is requesting that this European residue data in field-grown black and red currants be used to establish an import tolerance for currant, black and red of 4.0 ppm to facilitate trade from European countries.

Legume Vegetables (Crop Group 6):

Edible Podded legume vegetables (Subgroup 6A):
Podded bean:  Five field trials (two trials in/on French beans and three trials in/on kidney beans) were conducted in Northern Europe and eight field trials were conducted in/on kidney beans in Southern Europe.  In all 13 trials, two foliar spray applications of a 500 SC formulation of Fluopyram (250 g/L) and Trifloxystrobin (250 g/L) were made at 200 g trifloxystrobin/ha/application with a 7-day interval and 7-day PHI.   In the kidney bean trials, the 2[nd] of the two applications was made at crop growth stages ranging from BBCH 67 to BBCH 77 followed by the collection of fresh podded bean samples 7 days later.  As such, Bayer considers the fresh kidney bean pod samples along with the French bean samples to satisfy the requirement of a succulent cultivar of edible-podded beans (Phaseolus spp.).  Total trifloxystrobin residue expressed as parent equivalents, in edible-podded beans collected 7-days after last application were 0.03 to 0.257 ppm.  Using the OECD MRL calculator and total trifloxystrobin residues for podded beans collected at a 7-day PHI, the calculated tolerance for succulent edible-podded beans would be 0.4 ppm.
Podded peas:  Twenty field trials were conducted in/on field pea in Northern and Southern Europe with two foliar spray applications of a 500 SC formulation of Fluopyram (250 g/L) and Trifloxystrobin (250 g/L) at 200 g trifloxystrobin/ha/application with a 7-day interval and 7-day PHI.  Total trifloxystrobin residue expressed as parent equivalents, in edible-podded peas collected 7-days after last application were 0.038 to 0.843 ppm.  Using the OECD MRL calculator and total trifloxystrobin residues for podded peas collected at a 7-day PHI, the calculated tolerance for succulent edible-podded peas would be 1.5 ppm.

Bayer is requesting that this European residue data in succulent cultivars of edible-podded beans and peas be used to establish an import tolerance of 1.5 ppm for Edible-podded legume vegetables Subgroup 6A to facilitate trade from European countries.

Succulent Shelled peas and beans (Subgroup 6B):
Shelled beans:  Five field trials were conducted in/on kidney beans in Northern and Southern Europe in which samples of green seed were collected to satisfy the requirement for a succulent shelled cultivar of bean (Phaseolus spp.).  In all five trials, two foliar spray applications of a 500 SC formulation of Fluopyram (250 g/L) and Trifloxystrobin (250 g/L) were made at 200 g trifloxystrobin/ha/application with a 7-day interval and 14-day PHI.  In three of the trials, samples were also collected at 7-day PHI.  The 2[nd] of the two applications was made at a crop growth stage ranging from BBCH 67 (Flowering finishing: majority of petals fallen or dry) to BBCH 77 (70% of pods have reached typical length, pods still break cleanly) and green seed samples collected 7 and/or 14-days later.  As such, Bayer considers the green seed samples to satisfy the requirement for a succulent shelled cultivar of bean (Phaseolus spp.).  The total trifloxystrobin residues expressed as parent equivalent are shown in Table 1.

 Table 1:	Total trifloxystrobin residues expressed as parent (ppm)
                                    Trial #
                                  7-day PHI*
                                  14-day PHI
                                       1
                                     0.020
                                     0.020
                                       2
                                     0.020
                                     0.020
                                       3
                                     0.020
                                     0.067
                                       4
                                       -
                                     0.030
                                       5
                                       -
                                     0.061
* - = No sample

By using the 7-day PHI data along with the higher residue data seen at the 14-day PHI, the OECD MRL calculator calculates a tolerance for succulent shelled beans of 0.15 ppm.
Shelled peas: Fifteen field trials were conducted in/on field peas in Northern and Southern Europe in which samples of green seed were collected to satisfy the requirement for a succulent shelled cultivar of garden pea (pisium spp.).  In all fifteen trials, two foliar spray applications of a 500 SC formulation of Fluopyram (250 g/L) and Trifloxystrobin (250 g/L) were made at 200 g trifloxystrobin/ha/application with a 6 to 9-day interval and 7-day PHI.  Total trifloxystrobin residue expressed as parent equivalents, in succulent shelled peas collected 7-days after last application were <0.02 to 0.049 ppm.  Using the OECD MRL calculator and total trifloxystrobin residues for shelled peas collected at a 7-day PHI, the calculated tolerance for succulent shelled peas would be 0.08 ppm.

Bayer is requesting that this European residue data in succulent shelled cultivars of beans and garden peas be used to establish an import tolerance of 0.15 ppm for Succulent shelled pea and bean Subgroup 6B to facilitate trade from European countries.

Pea, Dry, Seed:
Dried peas:  Fourteen field trials were conducted in/on field peas in Northern and Southern Europe in which samples of dry seed were collected to satisfy the requirement for a dried cultivar of pea (Pisum spp.).  In all fourteen trials, two foliar spray applications of a 500 SC formulation of Fluopyram (250 g/L) and Trifloxystrobin (250 g/L) were made at 200 g trifloxystrobin/ha/application with a 7-day interval and 21-day PHI.  In three of the trials, samples were also collected at 14-day PHI.  The total trifloxystrobin residues expressed as parent equivalent are shown in Table 2.

 Table 2:	Total trifloxystrobin residues expressed as parent (ppm)
                                    Trial #
                                  14-day PHI*
                                  21-day PHI
                                       1
                                       -
                                     0.023
                                       2
                                       -
                                     0.025
                                       3
                                       -
                                     0.022
                                       4
                                       -
                                     0.138
                                       5
                                       -
                                     0.058
                                       6
                                       -
                                     0.020
                                       7
                                       -
                                     0.106
                                       8
                                     0.022
                                     0.022
                                       9
                                     0.020
                                     0.020
                                      10
                                     0.020
                                     0.020
                                      11
                                       -
                                     0.020
                                      12
                                       -
                                     0.020
                                      13
                                       -
                                     0.020
                                      14
                                       -
                                     0.020
* - = No sample

By using the 7-day PHI data along with the higher residue data seen at the 14-day PHI, the OECD MRL calculator calculates a tolerance for Dried shelled peas of 0.2 ppm.

Bayer is requesting that this European residue data in dried cultivars of field peas be used to establish an import tolerance 0.2 ppm for Pea, dry, seed to facilitate trade from European countries.

<B. Toxicological Profile>

<	1. Acute toxicity.  Trifloxystrobin is of low acute toxicity by oral, dermal, or inhalation routes of exposure (values greater than limit doses), but can cause dermal sensitization. Trifloxystrobin is a mild ocular and dermal irritant. >

<	2. Genotoxicty. Trifloxystrobin has been tested for its potential to induce gene mutation and chromosomal changes in five different test systems. The only positive finding was seen in an in vitro gene mutation assay in Chinese hamster V79 cells as a slight increase in mutant frequency at a very narrow range (250  -  278 g/mL) at cytotoxic and precipitating concentrations.  The chemical was found to be not genotoxic in all other in vitro and in vivo assay systems. Thus, the weight of the evidence indicates that trifloxystrobin is not genotoxic. >

<	3. Reproductive and developmental toxicity. In a developmental study in rats, reductions in body weight gain and food consumption were observed in the dams at 100 mg/kg/day. No teratogenic effects or any other effects were seen on pregnancy or fetal parameters. The maternal and developmental NOAELs were 10 and 1000 mg/kg/day, respectively.

	In the rabbit developmental study, body weight loss and reduced food consumption were observed in the dams at 50 mg/kg/day, resulting in a maternal NOAEL of 10 mg/kg/day. No teratogenic effects or any other effects were seen on pregnancy or fetal parameters except for the increase in skeletal anomaly of fused sternebrae-3 and -4 at the top dose level of 500 mg/kg/day. This finding is regarded as a marginal effect on skeletal development that could have resulted from the 40-65% lower food intake during treatment at this dose level. The developmental NOAEL was 250 mg/kg/day.

	In the 2-generation rat reproduction study, body weight gain and food consumption were decreased at 750 ppm (55.3 mg/kg/day), especially in females during lactation. Consequently, the reduced pup weight gain during lactation (750 ppm) and the slight delay in eye opening (1500 ppm; 110.6 mg/kg/day) were judged to be a secondary effect of maternal toxicity. No other fetal effects or any reproductive changes were noted.  Both the parental and offspring NOAELs were 50 ppm (3.8 mg/kg/day). The reproductive NOAEL was 1500 ppm (110.6 mg/kg/day). >

<	4. Subchronic toxicity. The liver was the target organ in all species tested with effects characterized by increases in liver weights and an increased incidence of hepatocellular hypertrophy and/or hepatocellular necrosis.  In subchronic testing, NOAELs were 500 ppm in rats [30.6 (M) and 32.8 (F) mg/kg/day] and mice [76.9 (M) and 110 (F) mg/kg/day] and 30 mg/kg/day in dogs.

In a 28 - day dermal toxicity study in rats, the NOAEL was 1000 mg/kg/day, the highest dose level tested. >

<	5. Chronic toxicity. The liver was also the target organ in chronic testing in dogs and mice with findings similar to those seen in the subchronic studies.  The chronic NOAELs were 5 mg/kg/day in dogs and 300 ppm in mice [39.4 (M) and 35.7 (F) mg/kg/day].  In rats, a NOAEL of 250 ppm [9.81 (M) and 11.37 (F) mg/kg/day] was established based on decreased mean body weight and decreased mean body weight gain at the LOAEL of 750 ppm [29.7 (M) and 34.5 (F) mg/kg/day].

Trifloxystrobin did not cause any treatment-related increase in general tumor incidence, any elevated incidence of rare tumors, or shortened time to the development of palpable or rapidly lethal tumors in the 18-month mouse and the 24-month rat studies.  EPA determined that trifloxystrobin should be classified as "Not Likely to be Carcinogenic to Humans" based on the lack of evidence for carcinogenicity in rats and mice.  >

<	6. Animal metabolism. Trifloxystrobin is moderately absorbed from the gastrointestinal tract of rats and is rapidly distributed. Subsequent to a single oral dose, the elimination half-life is about 2 days and excretion is primarily via bile. Trifloxystrobin is extensively metabolized by the rat into about 35 metabolites, but the primary actions are on the methyl ester (hydrolysis into an acid), the methoxyimino group (O-demethylation), and the methyl side chain (oxidation to a primary alcohol). Metabolism is dose dependent as it was almost complete at low doses but only about 60% complete at high doses.

In the goat, elimination of orally administered trifloxystrobin is primarily via the feces. The major residues were the parent compound and the acid metabolite (CGA-321113) plus its conjugates. In the hen, trifloxystrobin is found as the major compound in tissues and in the excreta, but hydroxylation of the trifluormethyl-phenyl moiety and other transformations, including methyl ester hydrolysis and demethylation of the methoxyimino group, are also seen. In conclusion, the major pathways of metabolism in the rat, goat, and hen are the same.  >

<	7. Metabolite toxicology. Metabolism of trifloxystrobin has been well characterized in plants, soil, and animals. In plants and soil, photolytically induced isomerization results in a few minor metabolites not seen in the rat; however, most of the applied material remained as parent compound as shown in the apple and cucumber studies. All quantitatively major plant and/or soil metabolites were also seen in the rat. The toxicity of the major acid metabolite, CGA-321113 (formed by hydrolysis of the methyl ester), has been evaluated in cultured rat hepatocytes and found to be 20-times less cytotoxic than the parent compound. Additional toxicity studies were conducted for several minor metabolites seen uniquely in plants and/or soil. The studies indicate that these metabolites, including CGA-357261, CGA-373466, and NOA-414412, are not mutagenic to bacteria and are of low acute toxicity (LD50 >2000 mg/kg). In conclusion, the metabolism and toxicity profiles support the use of an analytical enforcement method that accounts for parent trifloxystrobin. >

<	8. Endocrine disruption. Trifloxystrobin does not belong to a class of chemicals known for having adverse effects on the endocrine system. Developmental toxicity studies in rats and rabbits and reproduction study in rats gave no indication that trifloxystrobin might have any effects on endocrine function related to development and reproduction. The subchronic and chronic studies also showed no evidence of effects related to the endocrine system. >

<C. Aggregate Exposure>

<	1. Dietary exposure.  The most recent EPA acute and chronic dietary assessment was conducted for Registration Review (D439350, 5/31/2017).  This assessment did not include the proposed import tolerance for flax seed or proposed import tolerances on olives, legume vegetables, raspberries and currants.  The addition of proposed tolerances will have negligible impact on the dietary exposure previously conducted by EPA.  Assessments, using the most recent DEEM FCID Version 4.02 software, were conducted to evaluate potential risks due to chronic and acute dietary exposure of the U.S. population and selected population subgroups to residues of trifloxystrobin.  Consumption data used in this program were taken from NHANES WWEIA 2005-2010.  These analyses cover all registered crops plus the proposed new uses.

A dietary assessment was evaluated based on established tolerances for all registered uses and 100% crop treated.  For the proposed new uses on pea, dry, seed, the proposed tolerance of 0.2 ppm was used in this assessment.  Dry peas can be used as alternative feedstuff serving as a source of roughage and protein.  The proposed uses are not feed to feedlot beef.  Addition of the proposed uses on feed items will have minimal effect on total burden for dairy cattle.  The current risk assessments are based on established livestock tolerances (milk = 0.02 ppm) which are more conservative than residues estimated from Maximum Reasonably Balanced Diets (MRBD).

The EPA has established an acute Population Adjusted Dose (aPAD) of 2.5 mg/kg/day for acute dietary risk assessments based on a NOAEL of 250 mg/kg bw/day from a rabbit developmental toxicity study and an uncertainty factor or 100. The FQPA safety factor was reduced to 1x based on toxicological considerations by the FQPA Safety Factor Committee (HED Doc. No. 013545, B. Tarplee, 01/JUL/1999), the conservative residue assumptions used in the dietary exposure risk assessments, and the completeness of the residue chemistry and environmental fate databases (DP Num: 3 17330, B. O'Keefe,1 6/AUG/2006).  For chronic dietary analyses, the EPA established a chronic Population Adjusted Dose (cPAD) of 0.038 mg/kg/day based on a NOAEL of 3.8 mg/kg bw/day from the rat reproduction toxicity study and an uncertainty factor of 100.

Results from the acute and chronic dietary exposure analyses described below demonstrate a reasonable certainty that no harm to the overall U.S. population or any population subgroup will result from the use of trifloxystrobin on currently registered uses plus the proposed uses on flax seed or new proposed tolerances on olives, legume vegetables, raspberries and currants.

<	i. Food.  The acute assessments used 100% crop treated and tolerance level residue values.  The partially refined chronic assessment used percent crop treated where available, with both tolerance residue levels and average field trial residues for selected crops.  Acute exposure for food only, expressed at the 95[th] percentile of exposure, was 2.4% of the aPAD for Females 13-49 years old (only population subgroup of concern).  The chronic exposure was 9% cPAD for the Total US Population and 19% cPAD for the most sensitive population (Children 1-2 yrs. old).

<	ii. Drinking water. Additional import tolerances will have no impact on the previous estimation of trifloxystrobin in drinking water.  Estimated Drinking Water Concentrations (EDWCs) associated with trifloxystrobin use on all crops were calculated using PRZM-GW (ver. 1.07) and GENEEC to calculate ground water and surface water EDWCs, respectively.  The maximum acute and chronic ground water concentrations estimated by PRZM-GW were 631 ppb and 356 ppb, respectively, and were higher than the surface water estimates.  The value from the highest PRZM-GW exposure scenarios were incorporated into the dietary risk assessment.  The addition of the acute estimated drinking water concentration (EDWC) of 631 ppb resulted in 3.3% of the aPAD utilized for females 13-49 yrs. old.  The addition of the chronic EDWC of 356 ppb utilized 28% of the cPAD for the US Population and 79% of the cPAD for Infants (< 1 years old), the most highly exposed subpopulation.  In conclusion, the results of the acute and chronic dietary exposure analyses (including drinking water) are acceptable for all population subgroups examined.  Therefore, there is a reasonable certainty that no harm will result from exposure to potential residues of trifloxystrobin in food and water.

<	2. Non-dietary exposure. Addition of import tolerances for olives, legume vegetables, raspberries and currants will have no impact on the non-dietary exposure to trifloxystrobin. As such, non-dietary exposures from this change are covered by previous non-dietary risk assessments performed by EPA.

D. Cumulative Effects>

<	EPA has determined, as published in the Federal Register (FR Vol 73, no. 1, 02-Jan-08)), that unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, trifloxystrobin does not appear to produce a toxic metabolite produced by other substances. Therefore, EPA has not assumed that trifloxystrobin has a common mechanism of toxicity with other substances.

E. Safety Determination>

<	1. U.S. population.  Risk assessments for trifloxystrobin are based on a complete and reliable toxicity data package and highly conservative assumptions. Chronic aggregate dietary (food and water) exposure will utilize about 28% of the cPAD for the US Population.  Acute aggregate dietary exposure (food and water) for the females 13-49 yrs. old (the only population of concern) utilized 3.3% of the aPAD.  Therefore, there is a reasonable certainty that no harm will occur to the US Population from aggregate exposure (food and drinking water) to residues of trifloxystrobin. >>

<	2. Infants and children. No indication of increased susceptibility of rat or rabbit fetuses to in utero and/or postnatal exposure was noted in the developmental and reproductive toxicity studies.  EPA has determined that the toxicology database for trifloxystrobin regarding potential pre- and post-natal effects in children is complete and does not indicate any particular developmental or reproductive concerns.  The special FQPA SF has been reduced to 1X.

Using the conservative assumptions described in the exposure section above, chronic dietary exposure to residues of trifloxystrobin in food and water for Infants (< 1 years old) (the most highly exposed sub group) is 79% of the cPAD.  There is no acute endpoint of concern for children and infants.  There are no non-dietary concerns for infants and children.>

F. International Tolerances

International and CODEX tolerances (MRLs) for trifloxystrobin are established for many crops in various countries including dry peas and beans.


[Federal Register Volume 83, Number 7 (Wednesday, January 10, 2018)]
[Notices]
[Pages 1281-1282]
[FR Doc No: 2018-00245]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2017-0130]

Petition for Waiver of Compliance

    Under part 211 of Title 49 Code of Federal Regulations (CFR), this
provides the public notice that on December 20, 2017, the Association
of American Railroads (AAR), on behalf of itself and its member
railroads, petitioned the Federal Railroad Administration (FRA) for a
waiver of compliance from certain provisions of the Federal railroad
safety regulations contained at 49 CFR part 232, Brake System Safety
Standards for Freight and Other Non-Passenger Trains and Equipment;
End-of-Train Devices. FRA assigned the petition Docket Number FRA-2017-
0130.
    In its petition, AAR requests a waiver of compliance from the
requirement of 49 CFR 232.205(b)-Class I brake test-initial terminal
inspection, 232.209(a)--Class II brake tests--intermediate inspection,
232.211(a)--Class III brake tests-trainline continuity inspection, and
232.217(c)--Train brake tests conducted using yard air; for the common
element that the test or inspection must be performed if (among other
requirements) the car or cars have been off-air for more than four
hours. AAR requests that the four-hour off-air restrictions in these
four regulations be replaced by a 24-hour off-air restriction, which
would reflect substantial advancements in air brake technology since
the rule was promulgated, and would harmonize United States and
Canadian operations.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE, W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    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 Avenue SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE, Room W12-140,
Washington, DC 20590, between 9 a.m.

and 5 p.m., Monday through Friday, except Federal Holidays.
    Communications received by February 26, 2018 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.). In
accordance with 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.

Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2018-00245 Filed 1-9-18; 8:45 am]
 BILLING CODE 4910-06-P