[Federal Register Volume 83, Number 247 (Thursday, December 27, 2018)]
[Notices]
[Pages 66806-66808]
[FR Doc No: 2018-27993]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84869; File No. SR-BOX-2018-38]

Self-Regulatory Organizations; BOX Exchange LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To amend Rule
7260 by Extending the Penny Pilot Program Through June 30, 2019

December 19, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 18, 2018, BOX Exchange LLC (the ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I and II below, which Items have been
prepared by the self-regulatory organization. The Commission is
publishing this notice to solicit comments on the proposed rule 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 extend the effective time period of the
Penny Pilot Program that is currently scheduled to expire on December
31, 2018, until June 30, 2019. The text of the proposed rule change is
available from the principal office of the Exchange, at the
Commission's Public Reference Room and also on the Exchange's internet
website at http://boxoptions.com.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
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 extend the effective time period of the
Penny Pilot Program that is currently scheduled to expire on December
31, 2018, until June 30, 2019.\3\ The Penny Pilot Program permits
certain classes to be quoted in penny increments. The minimum price
variation for all classes included in the Penny Pilot Program, except
for PowerShares QQQ Trust (``QQQQ'')[supreg], SPDR S&P 500 Exchange
Traded Funds (``SPY''), and iShares Russell 2000 Index Funds (``IWM''),
will continue to be $0.01 for all quotations in options series that are
quoted at less than $3 per contract and $0.05 for all quotations in
options series that are quoted at $3 per contract or greater. QQQQ,
SPY, and IWM will continue to be quoted in $0.01 increments for all
options series.
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    \3\ The Penny Pilot Program has been in effect on the Exchange
since its inception in May 2012. See Securities Exchange Act Release
Nos. 66871 (April 27, 2012), 77 FR 26323 (May 3, 2012) (File No.10-
206, In the Matter of the Application of BOX Options Exchange LLC
for Registration as a National Securities Exchange Findings,
Opinion, and Order of the Commission), 67328 (June 29, 2012), 77 FR
40123 (July 6, 2012) (SR-BOX-2012-007), 68425 (December 13, 2012),
77 FR 75234 (December 19, 2013) (SR-BOX-2012-021), 69789 (June 18,
2013), 78 FR 37854 (June 24, 2013) (SR-BOX-2013-31), 71056 (December
12, 2013), 78 FR 76691 (December 18, 2013) (SR-BOX-2013-56), 72348
(June 9, 2014), 79 FR 33976 (June 13, 2014) (SR-BOX-2014-17), 73822
(December 11, 2014), 79 FR 75606 (December 18, 2014) (SR-BOX-2014-
29), 75295 (June 25, 2015), 80 FR 37690 (July 1, 2015)(SR-BOX-2015-
23), 78172 (June 28, 2016), 81 FR 43325 (July 1, 2016)(SR-BOX-2016-
24), 79429 (November 30, 2016), 81 FR 87991 (December 6, 2016)(SR-
BOX-2016-55), 80828 (May 31, 2017), 82 FR 26175 (June 6, 2017) (SR-
BOX-2017-18), 82353 (December 19, 2017) 82 FR 61087 (December 26,
2017)(SR-BOX-2017-37), and 83500 (June 22, 2018), 83 FR 30471 (June
28, 2018)(SR-BOX-2018-23). The extension of the effective date and
the revision of the date to replace issues that have been delisted
are the only changes to the Penny Pilot Program being proposed at
this time.
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    The Exchange may replace, on a semi-annual basis, any Pilot Program
classes that have been delisted on the second trading day following
January 1, 2019. The Exchange notes that the replacement classes will
be selected based on trading activity for the six month period
beginning June 1, 2018 and ending November 30, 2018 for the January
2019 replacements. The Exchange will employ the same parameters to
prospective replacement classes as approved and applicable under the
Pilot Program, including excluding high-priced underlying

securities. The Exchange will distribute a Regulatory Circular
notifying Participants which replacement classes shall be included in
the Penny Pilot Program.
    BOX is specifically authorized to act jointly with the other
options exchanges participating in the Pilot Program in identifying any
replacement class.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\4\ in general, and Section
6(b)(5) of the Act,\5\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general protect investors
and the public interest.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
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    In particular, the proposed rule change, which extends the Penny
Pilot until June 30, 2019 and changes the date for replacing Penny
Pilot issues that were delisted to the second trading day following
January 1, 2019, will enable public customers and other market
participants to express their true prices to buy and sell options for
the benefit of all market participants. This is consistent with the
Act.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. To the contrary, this proposal
is pro-competitive because it allows Penny Pilot issues to continue
trading on the Exchange. Moreover, the Exchange believes that the
proposed rule change will allow for further analysis of the Pilot and a
determination of how the Pilot should be structured in the future; and
will serve to promote regulatory clarity and consistency, thereby
reducing burdens on the marketplace and facilitating investor
protection. The Pilot is an industry wide initiative supported by all
other option exchanges. The Exchange believes that extending the Pilot
will allow for continued competition between market participants on the
Exchange trading similar products as their counterparts on other
exchanges, while at the same time allowing the Exchange to continue to
compete for order flow with other exchanges in option issues trading as
part of the Pilot.

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 comments on the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A) of the Act \6\ and Rule 19b-4(f)(6) \7\ thereunder. 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 after the date of the filing, or such shorter time as the
Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to 19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(6)
\9\ thereunder.
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    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(6).
    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
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.
The Exchange has satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \10\ normally
does not become operative prior to 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\11\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Commission believes
that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest because doing so will
allow the Pilot Program to continue without interruption in a manner
that is consistent with the Commission's prior approval of the
extension and expansion of the Pilot Program.\12\ Accordingly, the
Commission designates the proposed rule change as operative upon filing
with the Commission.\13\
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    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ 17 CFR 240.19b-4(f)(6)(iii).
    \12\ See Securities Exchange Release No. 61061 (November 24,
2009), 74 FR 62857 (December 1, 2009) (SR-NYSEArca-2009-44).
    \13\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BOX-2018-38 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BOX-2018-38. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, on official business days
between the hours of 10:00 a.m.

and 3:00 p.m., located at 100 F Street NE, Washington, DC 20549. Copies
of such filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change. Persons submitting comments are cautioned that we do
not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-BOX-
2018-38 and should be submitted on or before January 17, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2018-27993 Filed 12-26-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 5 (Friday, January 7, 2022)]
[Proposed Rules]
[Pages 913-916]
[FR Doc No: 2021-28503]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2021-N-0471]

Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption Relating to Agricultural Water; Proposed
Rule; Public Meetings; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meetings; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing two virtual public meetings entitled ``Standards for the
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption Relating to Agricultural Water.'' The purpose of the public
meetings is to discuss the proposed rule entitled ``Standards for the
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption Relating to Agricultural Water,'' which was issued under
the FDA Food Safety Modernization Act (FSMA). These public meetings are
intended to facilitate and support the public's evaluation and
commenting process on the proposed rule.

DATES: The public meetings will be held virtually on February 14, 2022,
from 11:45 a.m. Eastern Time to 7:45 p.m. Eastern Time and February 25,
2022, from 8:45 a.m. Eastern Time to 4:45 p.m. Eastern Time. Submit
either electronic or written comments on the proposed rule ``Standards
for the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption Relating to Agricultural Water'' by April 5, 2022. See
``How to Participate in the Public Meetings'' in the SUPPLEMENTARY
INFORMATION section of this document for closing dates for advanced
registration and other information regarding meeting participation.

ADDRESSES: Due to the impact of the COVID-19 pandemic, these meetings
will be held virtually to help protect the public and limit the spread
of the virus.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before April 5, 2022. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of

April 5, 2022. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-0471 for the proposed rule ``Standards for the Growing,
Harvesting, Packing, and Holding of Produce for Human Consumption
Relating to Agricultural Water.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For general questions about the public
meetings or for special accommodations due to a disability, contact
Juanita Yates, Center for Food Safety and Applied Nutrition (HFS-009),
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
240-402-1731, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Congress enacted FSMA (Pub. L. 111-353) in 2011 in response to
dramatic changes in the global food system and in our understanding of
foodborne illness. FSMA transformed the nation's food safety system by
shifting the focus from responding to foodborne illness to preventing
it.
    In November 2015, FDA issued the ``Standards for the Growing,
Harvesting, Packing, and Holding of Produce for Human Consumption''
rule (80 FR 74354, November 27, 2015) (2015 produce safety final rule)
(codified at part 112 (21 CFR part 112)), which established science-
based minimum standards for the safe growing, harvesting, packing, and
holding of fruits and vegetables grown for human consumption. The
provisions of the rule focus on addressing major routes of microbial
contamination--including agricultural water; biological soil
amendments; domesticated and wild animals; worker health and hygiene;
and equipment, buildings, and tools.
    Part 112, subpart E in the 2015 produce safety final rule, which
outlines standards for agricultural water, includes a general
requirement that agricultural water must be safe and adequate for its
intended uses (Sec.  112.41). It also includes microbial water quality
criteria (Sec.  112.44) and requirements for testing certain water
sources (Sec.  112.46). The microbial quality criteria are based on the
intended use of the agricultural water, such as for growing activities
for covered produce other than sprouts (including irrigation water
applied using direct water application methods and water used in
preparing crop sprays) (commonly referred to as ``pre-harvest
agricultural water''),\1\ and for certain other specified uses,
including sprout irrigation water and water applications that directly
contact covered produce during or after harvest.\2\ Since finalizing
the rule, however, we have received consistent feedback from
stakeholders expressing concern about the complexity of and
implementation challenges with certain agricultural water requirements.
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    \1\ The produce safety regulation refers to pre-harvest
agricultural water used during sprout production as ``sprout
irrigation water.''
    \2\ Because sprouts present a unique safety risk, the produce
safety regulation establishes sprout-specific requirements on
multiple topics, including agricultural water.
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    Accordingly, in the Federal Register of December 6, 2021 (86 FR
69120), FDA published the proposed rule entitled ``Standards for the
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption Relating to Agricultural Water'' (2021 agricultural water
proposed rule). This proposed rule would amend the agricultural water
provisions of the produce safety regulation to replace the microbial
criteria and testing requirements for pre-harvest agricultural water
for covered produce (other than sprouts) that

covered farms have found to be complex and challenging to implement,
with provisions for comprehensive assessments of pre-harvest
agricultural water systems, practices, and on-farm conditions.
    The proposed agricultural water assessments would provide
additional flexibility to covered farms, using a systems-based approach
that would be feasible to implement across the wide variety of pre-
harvest agricultural water systems, uses, and farm operations and would
be adaptable as scientific understanding of agricultural water quality
expands in the future. We also are proposing to require expedited
mitigation for hazards related to certain activities associated with
adjacent and nearby land in light of findings from several recent
produce outbreak investigations.
    These proposed revisions to the produce safety regulation, if
finalized, would set forth requirements for comprehensive pre-harvest
agricultural water assessments and mitigation measures that minimize
the risk of serious adverse health consequences or death, including
those reasonably necessary to prevent the introduction of known or
reasonably foreseeable biological hazards into or onto produce, and to
provide reasonable assurances that the produce is not adulterated on
account of these hazards.
    FDA is announcing two virtual public meetings entitled ``Standards
for the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption Relating to Agricultural Water'' so that stakeholders can
better understand, evaluate, and comment on the proposed rule. These
meetings will be held during the formal comment period on the proposed
rule. The two public meetings will cover the same agenda items and are
intended to facilitate and support the public's evaluation and
commenting process.

II. Purpose and Format of the Public Meetings

    The purpose of the public meetings is to provide information and
facilitate public comment on the proposed rule. We invite interested
parties to provide information and offer comments related to the
proposed rule. During the public meetings we will provide an overview
of the current requirements that apply for pre-harvest agricultural
water for non-sprout covered produce and discuss the proposed
provisions for systems-based pre-harvest agricultural water assessments
that are designed to be more feasible to implement across the wide
variety of agricultural water systems, uses, and practices, while also
being adaptable to future advancements in agricultural water quality
science and achieving improved public health protections. There will be
an opportunity for questions, as well as an opportunity for open public
comment.

III. How to Participate in the Public Meetings

    There will be a total of two virtual public meetings with different
timeframes, which will provide persons in different regions an
opportunity to comment on the proposed rule.
    Table 1 provides information on participation in the public
meetings.

  Table 1--Information on Participating in the Public Meetings and on Submitting Comments to the Proposed Rule
                                                     Docket
----------------------------------------------------------------------------------------------------------------
               Activity                          Date              Electronic address       Other information
----------------------------------------------------------------------------------------------------------------
First public meeting.................  February 14, 2022;       Webcast information      Webcast will have
                                        11:45 a.m. to 7:45       will be sent upon        closed captioning.
                                        p.m. EST.                completion of
                                                                 registration.
Request to make an oral presentation.  By February 2, 2022....  https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements.
Notice confirming opportunity to make  By February 4, 2022....  .......................  An Agency
 an oral presentation.                                                                    representative will
                                                                                confirm the
                                                                                opportunity to make an
                                                                                oral presentation and
                                                                                will provide the
                                                                                approximate time on
                                                                                the public meeting
                                                                                agenda to do so.
Second public meeting................  February 25, 2022; 8:45  Webcast information      Webcast will have
                                        a.m. to 4:45 p.m. EST.   will be sent upon        closed captioning.
                                                                 completion of
                                                                 registration.
Request to make an oral presentation.  By February 11, 2022...  https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements.
Notice confirming opportunity to make  By February 15, 2022...  .......................  An Agency
 an oral presentation.                                                                    representative will
                                                                                confirm the
                                                                                opportunity to make an
                                                                                oral presentation and
                                                                                will provide the
                                                                                approximate time on
                                                                                the public meeting
                                                                                agenda to do so.
Submitting either electronic or        Submit comments by       https://                 See ADDRESSES for
 written comments.                      April 5, 2022.           www.regulations.gov.     additional information
                                                                                on submitting
                                                                                comments.
----------------------------------------------------------------------------------------------------------------

IV. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at: https://www.regulations.gov. You may also view
the transcript at the Dockets Management Staff (see ADDRESSES).

    Dated: December 29, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28503 Filed 1-6-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)]
[Notices]
[Page 25496]
[FR Doc No: 2018-11917]

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Securities and Exchange Commission

Sunshine Act Meeting

TIME AND DATE: Notice is hereby given, pursuant to the provisions of
the Government in the Sunshine Act, Public Law 94-409, that the
Securities and Exchange Commission will hold an Open Meeting on
Tuesday, June 5, 2018 at 10:00 a.m.

PLACE: The meeting will be held in the Multi-Purpose Room L-006 at the
Commission's headquarters, 100 F Street NE, Washington, DC 20549.

STATUS: The meeting will begin at 10:00 a.m. (ET) and will be open to
the public. Seating will be on a first-come, first-served basis.
Visitors will be subject to security checks. The meeting will be
webcast on the Commission's website at www.sec.gov.

MATTERS TO BE CONSIDERED: The subject matters of the Open Meeting will
be the Commission's consideration of:
     Whether to adopt a new rule as well as amendments to rules
and forms to provide certain registered investment companies
(``funds'') with an optional method to transmit shareholder reports.
     whether to issue a release requesting comment about
processing fees for delivering shareholder reports and other materials
to fund investors.
     whether to issue a release requesting comment from
individual investors and other interested parties on how to enhance the
delivery, design, and content of fund disclosures, including
shareholder reports and prospectuses.
     whether to propose amendments to rules adopted under
section 13 of the Bank Holding Company Act related to prohibitions and
restrictions on proprietary trading and certain interests in, and
relationships with, hedge funds and private equity funds (commonly
known as the ``Volcker rule'').
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.

CONTACT PERSON FOR MORE INFORMATION: For further information, please
contact Brent J. Fields from the Office of the Secretary at (202) 551-
5400.

    Dated: May 29, 2018.
Brent J. Fields,
Secretary.
[FR Doc. 2018-11917 Filed 5-30-18; 4:15 pm]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 65 (Wednesday, April 7, 2021)]
[Notices]
[Pages 18056-18057]
[FR Doc No: 2021-06652]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10021-58-OA]

National Environmental Education Advisory Council

AGENCY: Environmental Protection Agency (EPA).

ACTION: Request for nominations.

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SUMMARY: The U.S. Environmental Protection Agency (EPA or Agency)
office of Public Engagement and Environmental Education is soliciting
applications for environmental education professionals for
consideration to serve on the National Environmental Education Advisory
Council (NEEAC). There are two vacancies on the Advisory Council that
must be filled. Additional avenues and resources may be utilized in the
solicitation of applications. In an effort to obtain nominations of
diverse candidates, EPA encourages nominations of women and men of all
racial and ethnic groups.

DATES: Applications are due no later than May 14, 2021.

ADDRESSES: Submit nominations electronically (preferred) and
application materials to Javier Araujo, Designated Federal Officer,
National Environmental Education Advisory Council, U.S. Environmental
Protection Agency, Office of Public Engagement and Environmental
Education, (MC 1704A), 1200 Pennsylvania Ave. NW, Room 1426 (WJCN),
Washington, DC 20460, Phone:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: For information regarding this Request
for Nominations, please contact Mr. Javier Araujo, Designated Federal
Officer<EMAIL_ADDRESS>202-564-2642, U.S. EPA, Office of
Environmental Education, William Jefferson Clinton North, Room 1426,
1200 Pennsylvania Avenue NW, Washington, DC 20460.
    General Information concerning NEEAC can be found on the EPA
website at: https://www.epa.gov/education/national-environmental-education-advisory-council-neeac.

SUPPLEMENTARY INFORMATION: The National Environmental Education Act
requires that the council be comprised of (11) members appointed by the
Administrator of the EPA. Members represent a balance of perspectives,
professional qualifications, and experience. The Act specifies that
members must represent the following sectors: Primary and secondary
education (one of whom shall be a classroom teacher), two members;
colleges and universities, two members; business and industry, two
members; non-profit organizations, two members; state departments of
education and natural resources, two members, and one member to
represent senior Americans. Members are chosen to represent various
geographic regions of the country, and the Council strives for a
diverse representation. The professional backgrounds of Council members
should include education, science, policy, or other appropriate
disciplines. Each member of the Council shall hold office for a one (1)
to three (3) year period. Members are expected to participate in up to
two (2) meetings per year and monthly or more conference calls per
year. Members of the council shall receive compensation and allowances,
including travel expenses at a rate fixed by the Administrator.
    Expertise Sought: The NEEAC staff office seeks candidates with
demonstrated experience and or knowledge in any of the following
environmental education issue areas: (a) Integrating environmental
education into state and local education reform and improvement; (b)
state, local and tribal level capacity building for environmental
education; (c) cross-sector partnerships to foster environmental
education; (d) leveraging resources for environmental education; (e)
design and implementation of environmental education research; (f)
evaluation methodology; professional development for teachers and other
education professionals; and targeting under-represented audiences,
including low-income, multi-cultural, senior citizens and other adults.
    The NEEAC is best served by a structurally and geographically
diverse group of individuals. Each individual will demonstrate the
ability to make a time commitment. In addition, the individual will
demonstrate both strong leadership and analytical skills. Also, strong
writing skills, communication skills and the ability to evaluate
programs in an unbiased manner are essential. Team players, which can
meet deadlines and review items on short notice are ideal candidates.
    Persons having questions about the application procedure or who are
unable to submit applications by electronic means, should contact
Javier Araujo (DFO), at the contact information provided above in this
notice. Non-electronic submissions must contain the same information as
the electronic. The NEEAC staff Office will acknowledge receipt of the
application. The NEEAC staff office will develop a short list of
candidates for more detailed consideration. The short list candidates
will be required to fill out the Confidential Disclosure Form for
Special Government Employees serving Federal Advisory Committees at the
U.S. Environmental Protection Agency. (EPA form 3110-48). This
confidential form allows government officials to determine whether
there is a statutory conflict between that person's public
responsibilities (which include membership on a Federal Advisory
Committee) and private interests and activities and the appearance of a
lack of impartiality as defined by Federal regulation. The form may be
viewed and downloaded from the following URL address. Please note this
form is not an application form. http://intranet.epa.gov/ogc/ethics/EPA3110-48ver3.pdf.
    How to Apply: Any interested and qualified individuals may be
considered for appointment on the National Environmental Education
Advisory

Council. In order to apply, the following four items should be
submitted in electronic format to the Designated Federal Officer,
Javier Araujo<EMAIL_ADDRESS>and contain the following: (1)
Contact information including name, address, phone and fax numbers and
an email address (2) a curriculum vitae or resume, (3) the specific
area of expertise in environmental education and the sector or slot the
applicant is applying for, (4) recent service on other national
advisory committees or national professional organizations; a one page
commentary on the applicant's philosophy regarding the need for,
development, implementation and or management of environmental
education nationally.

Hiram Lee Tanner III,
Director, Office of Environmental Education.
[FR Doc. 2021-06652 Filed 4-6-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 100 (Wednesday, May 23, 2012)]
[Notices]
[Page 30522]
[FR Doc No: 2012-12447]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER12-1764-000]

Amplified Power & Gas, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Amplified Power & Gas, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability, is June 5, 2012.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also 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 email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 16, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-12447 Filed 5-22-12; 8:45 am]
BILLING CODE 6717-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

	Date:	October 3, 2007

	Subject:	Fluroxypyr.  PP#6E7168.  Section 3 Registration Request for
Uses on Pome Fruit and Millet.  Summary of Analytical Chemistry and
Residue Data.

DP Barcode:	336178	Decision Number:	373266

PC Codes:	128959 & 128968	MRID No.:	47017101, 47017102

40 CFR 180.	535

Chemical Class:	Pyridinoxy acid

	From:	Donna S. Davis, Chemist

		Reregistration Branch 1

		Health Effects Division (7509P)

	Through:	Toiya Goodlow, Chemist

		Michael S. Metzger, Chief

		Reregistration Branch 1

		Health Effects Division (7509P)

To:		Shaja Brothers, Risk Assessor

		Barbara Madden, Minor Use Team Leader

		Daniel Rosenblatt, Chief

		Risk Integration, Minor Use, and Emergency Response Branch

		Registration Division (7505P)

This document was originally prepared under contract by Dynamac
Corporation (2275 Research Blvd, Suite 300; Rockville, MD 20850;
submitted 06/13/2007).  The document has been reviewed by the Health
Effects Division (HED) and revised to reflect current Office of
Pesticide Programs (OPP) policies.

Executive Summary

Fluroxypyr [((4-amino-3, 5-dichloro-6-fluoro-2-pyridinyl) oxy) acetic
acid] is a selective herbicide intended for postemergence control of
annual and perennial broadleaf weeds.

The end-use product (EP) for this action is StaraneTM Herbicide (EPA
Reg. No. 62719-286), an emulsifiable concentrate formulation of 26.2%
fluroxypyr 1-methylheptyl ester (fluroxypyr 1-MHE), which is 1.5 lb acid
equivalent (ae)/gal (18.2% ae).  StaraneTM Herbicide is presently
registered for uses on cereal grains [barley, corn (field and sweet),
oats, sorghum, and wheat], grasses (pasture and rangeland), and onions
(dry bulb).

The Interregional Research Project No. 4 (IR-4), on behalf of the
Agricultural Experiment Stations of GA, NC, SC, ND, SD, TN and/or WA, is
proposing to establish tolerances for residues of fluroxypyr to support
new uses on pome fruit and millet.  The proposed pome fruit use would be
as a single broadcast spray application directed to the soil at a
maximum rate of 0.5 lb ae/A per year with a 14-day preharvest interval
(PHI).  For millet grown for grain, forage, or hay, the proposed use is
for up to two broadcast postemergence applications at a total rate of
0.25 lb ae/A with a 7-day PHI for hay or silage.  IR-4 has submitted a
petition, PP#6E7168, for the establishment of permanent tolerances for
the combined residues of fluroxypyr 1-MHE and its metabolite fluroxypyr
in/on the following raw agricultural commodities:

Pome, fruit, group 11	0.02 ppm

Millet, grain	0.5 ppm

Millet, forage	12.0 ppm

Millet, hay	20.0 ppm

Millet, proso, grain	0.5 ppm

Millet, proso, straw	12.0 ppm

Millet, proso, forage	12.0 ppm

Millet, proso, hay	20.0 ppm

Millet, pearl, grain	0.5 ppm

Millet, pearl, forage	12.0 ppm

Millet, pearl, hay	20.0 ppm

Tolerances have been established for the combined residues of fluroxypyr
1-methylheptyl ester [1-methylheptyl
((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate] and its
metabolite fluroxypyr
[((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid] under 40
CFR 180.535. The established tolerances for plant commodities range from
0.02 ppm (field corn grain, sweet corn K+CWHR, and sorghum grain) to 160
ppm (grass hay) [40 CFR 180.535(a)].  The established tolerances for
livestock commodities range from 0.1 ppm (fat, meat, and meat
byproducts) to 1.5 ppm (kidney).

A pome fruit metabolism study is not available to support the proposed
use on pome fruit.  Wheat and onion metabolism studies for fluroxypyr
are available.  HED would typically required the conduct of metabolism
studies on three diverse crops to define the nature of the residue in
all plant commodities, or would require the conduct of a pome fruit
metabolism study to support the requested new use on pome fruit.
However, because the requested use of fluroxypyr in/on pome fruit
involves application to the orchard floor and available confined
rotational crops studies demonstrate low residue uptake, HED concludes
that significant fruit residues are not likely.  A pome fruit metabolism
study reflecting application to the orchard floor is not likely to
provide additional information, and is not required at this time.

Acceptable wheat and onion metabolism studies are available, and the
results can be translated to support the proposed use on millet.  The
wheat study has shown that the metabolism of fluroxypyr 1-MHE proceeds
through ester hydrolysis to form fluroxypyr, followed by conjugation
into various fluroxypyr-based moieties.  The residues of concern in
wheat are fluroxypyr 1-methylheptyl ester and its metabolite fluroxypyr,
free and conjugated, all expressed as fluroxypy.  Similar results and
metabolic profiles were obtained in the recently submitted onion
metabolism study.

The nature of the residue in livestock has been adequately defined based
on acceptable hen and goat metabolism studies.  The Agency has
determined that the residues of concern in livestock for tolerance
enforcement are fluroxypyr 1-MHE and its metabolite fluroxypyr, free and
conjugated, all expressed as fluroxypyr.

There are adequate residue analytical methods for tolerance enforcement
and data collection.  The gas chromatography/mass selective detector
(GC/MSD) Methods GRM 96.02 and 96.03 are the current enforcement methods
for residues of fluroxypyr in/on cereal grain and ruminant commodities,
respectively.  The methods convert the methylheptyl ester form of
fluroxypyr to the acid, and results are reported as the acid equivalent.
 Method GRM 96.02, with minor modifications, was used for the analysis
of samples from the submitted field trial and processing study
associated with this Summary Document.  The concurrent method recoveries
demonstrated that the method is adequate for data-collection.  The
lowest level of method validation (LLMV) for fluroxypyr and fluroxypyr
1-MHE was 0.010 ppm in pear and apple fruit, apple wet pomace and apple
juice.  Fluroxypyr has been tested through FDA multiresidue methods,
Protocols C through E.

There are adequate storage stability data to support the durations and
conditions of storage for the samples collected from the pome fruit
field trials and apple processing study.  Residues of fluroxypyr and
fluroxypyr 1-MHE were found to be stable in/on fortified apple fruit,
wet pomace and juice stored frozen for up to ~5 months, and in/on
fortified pear samples stored frozen for up to ~11 months.

The submitted residue data for apples and pears, the representative
commodities of the pome fruit crop group (crop group 11), are adequate
to fulfill data requirements.  The number and locations of crop field
trials are in accordance with OPPTS Guideline 860.1500.  The trials
reflect the proposed use pattern.

The available data for barley, oat, and wheat may be translated to
support the proposed use of fluroxypyr on millet provided the label
specifies a PHI of 14-days for hay and a PHI of 40-days for millet grain
and straw.

The submitted apple processing study is considered adequate to support
the proposed use.  While whole fruit samples treated at 1X the proposed
use pattern did not contain residues above the method LLMV, given that
this is a use to the orchard floor and confined rotational crop studies
do not show significant uptake of residues, it is unlikely that residues
will be detectable in whole fruit even from an exaggerated rate study.
The submitted study is adequate to demonstrate that residues in wet
apple pomace and apple juice are not likely to exceed the established
tolerance for the apple RAC.

The proposed new uses on pome fruit and millet are not expected to
significantly increase livestock dietary burdens given the currently
established uses and tolerances.  The existing livestock tolerances are
adequate to support the proposed new uses.

Adequate rotation crop data are available to support the proposed new
uses on pome fruit and millet.

Reference standards are available for fluroxypyr at the EPA National
Pesticide Standards Repository.  HED notes that this standard has an
expiration date of 7/2007.  HED recommends that the registrant for this
chemical provide a new standard or should recertify the lot in the
repository and send in an updated certificate of analysis (COA).

There are no Codex, Canadian or Mexican MRLs for fluroxypyr for pome
fruit or millet; therefore, there are no issues of international
harmonization raised by this action.

  SEQ CHAPTER \h \r 1 Regulatory Recommendations and Residue Chemistry
Deficiencies

Provided the deficiencies cited below are resolved, and further,
provided the forthcoming human health risk assessment does not identify
any risks of concern, there are no residue chemistry issues that would
preclude the establishment of the requested tolerances for the uses of
fluroxypyr on pome fruit and millet.

The submitted and/or translated data support the following tolerances
for the combined residues of fluroxypyr 1-methylheptyl ester
[1-methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate]
and its metabolite fluroxypyr
[((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid] of
fluroxypyr in/on the following raw agricultural commodities:

Fruit, pome, group 11	0.02 ppm

Millet, grain	0.5 ppm

Millet, forage	12.0 ppm

Millet, hay	20.0 ppm

Millet, proso, straw	12.0 ppm

Deficiencies

The use instructions for millet should be revised to reflect a PHI of
14-days for millet hay and a PHI of 40-days for grain and straw of
millet.

The petitioner should submit a revised Section F to reflect the revised
commodity definition presented in Table 9 on page 17 of this review.

Background

The chemical structure and nomenclature of fluroxypyr 1-MHE and
fluroxypyr (free acid) are presented in Table 1.  The physicochemical
properties of the technical grade of fluroxypyr 1-MHE are presented in
Table 2.

TABLE 1.	Fluroxypyr 1-MHE Nomenclature.

Compound

Common name	Fluroxypyr 1-methylheptyl ester

Company experimental name	XRM-5316

IUPAC name
1-methylheptyl-4-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetate

CAS name	[(4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy]acetic acid,
1-methylheptyl ester

CAS #	81406-37-3

End-use product/EP	1.5 lb ae/gal EC formulation (StaraneTM Herbicide;
EPA Reg. No. 62719-286)

Fluroxypyr, free acid

Common Name	Fluroxypyr

CAS name	[(4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy]acetic acid

CAS #	69377-81-7

TABLE 2.	Physicochemical Properties of the Fluroxypyr 1-MHE.

Parameter	Value	Reference

Melting point/range	57.5°C 	44080303

pH	6.81 in solution containing 90.1 µg/L	44080303

Density	1.30 g/mL at 21°C	44080303

Water solubility ( 20 °C)	90.1 µg/L in purified water

294 µg/L in pH 5 buffer

136 µg/L in pH 7 buffer

57.2 g/L in pH 9 buffer	44080303

Solvent solubility (20 °C)	6.23 g/100 mL in n-heptane

>200 g/100 mL in xylene

377 g/100 mL in methanol

22.0 g/100 mL in n-octanol

>300 g/100 mL in acetone	44080303

Vapour pressure	2.0 x 10-5 kPa at 25 °C

1.0 x  10-5 kPa at 20 °C	44080303

Dissociation constant	Not applicable

	Octanol/water partition coefficient Log(KOW)	4.57 at pH 5

5.04 at pH 7

5.31 at pH 9	44080303

UV/visible absorption spectrum	Not available

860.1200  Directions for Use

The end-use product for this action is StaraneTM Herbicide (EPA Reg. No.
62719-286), an emulsifiable concentrate formulation of 26.2% fluroxypyr
1-methylheptyl ester (fluroxypyr 1-MHE), which is 1.5 lb acid equivalent
(ae)/gal (18.2% ae).  The proposed uses on pome fruit and millet are
detailed in Table 3.

Table 3.  Summary of Directions for Use of Fluroxypyr 1-MHE.

Applic. Timing, Type, and Equip.	Formulation

[EPA Reg. No.]	Applic. Rate

(lb ae/A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb ae/A)	PHI

(days)	Use Directions and Limitations

Millet Grown for Grain, Forage or Hay

Postemergence, Broadcast,

Ground and aerial	1.5 lb ae/gal EC

[62719-286]	0.125	2	0.25	7 (grass for hay or silage)	Apply to millet in
the spring; new plantings of millet may be treated from the 2 true leaf
stage prior to the early boot stage.  A second application may be made
with a minimum 14-day RTI.  Do not apply during boot, flowering, or seed
development if grass crop is to be harvested for seed.  No grazing
restrictions are imposed for lactating or non-lactating dairy animals,
but meat animals must be withdrawn from treated forage at least 2 days
before slaughter.

Pome Fruit

Postemergence,

Broadcast,

Ground	1.5 lb ae/gal EC

[62719-286]	0.5	1	0.5	14	Apply uniformly with ground equipment in 10
GPA, avoiding contact with foliage.  Do not apply to trees <4 years old
or during bloom.

ximum seasonal rate of 1⅓ pints product/A (equivalent to 0.25 lb
ae/A); and that if replanting is required, only crops listed on the
label (or approved supplemental labels) may be planted within 120 days
following application.  StaraneTM may be applied in tank mix combination
with other products provided (i) the tank mix product is labeled for the
timing and method of application for the use site to be treated; and
(ii) tank mixing is not prohibited by the label of the tank mix product.
 Use of an adjuvant labeled for the growing crops is recommended for
improved weed control.

Conclusions:  The supplemental label for StaraneTM Herbicide (EPA Reg.
No. 62719-286) is adequate to allow evaluation of the residue data
relative to the proposed use.  The available data for barley, oat, and
wheat were translated to support the proposed use of fluroxypyr on
millet provided the final label is revised to specify a PHI of 14-days
for hay and a PHI of 40-days for grain and straw of millet.

860.1300 Nature of the Residue - Plants

Waiver Request for the Conduct of Additional Metabolism Studies

Dow AgroSciences has a submitted an overview of fluroxypyr plant
metabolism data (MRID 47017103) to support a waiver request for the
conduct of additional metabolism studies.  The waiver request document
summarized the available data including two existing nature of the
residue studies (wheat and onion), two confined rotational crop studies,
and two independent university metabolism studies that were conducted on
broadleaf weed species.  The petitioner states that the available data
are sufficient to predict the residue profile in pome fruit and
demonstrate that there would be no significant uptake of any soil
metabolites which may add to that profile.

Based on the aggregate of data, the petitioner contends that the
metabolism of fluroxypyr 1-MHE in plants is similar in wheat, onions,
and broad-leaved weeds.  Metabolism involves cleavage of the ester to
the acid, followed by conjugation of the acid.  Cleavage of the ether
linkage to yield the pyridinol metabolite was insignificant.
Furthermore, the primary route of uptake is through the plant cuticle,
and other forms of uptake (i.e., via the roots) are less significant.
The petitioner presented the following metabolic pathway for fluroxypyr
MHE shown below and taken directly without alteration from MRID
47017103.

In addition to weed metabolites, pome fruit roots may also be exposed to
soil degradates of fluroxypyr.  An aerobic soil metabolism study
demonstrated that fluroxypyr MHE is rapidly hydrolyzed to the acid,
though not completely as some of the ester remained more than 5 months
after application.  Mineralization to CO2 was a significant route of
degradation in the soil.  Two soil metabolites were formed:  pyridinol
and methoxypyridine.  The confined rotational crop studies (30-day PBI
(plant back interval) with wheat, lettuce and turnips) demonstrated that
the two soil metabolites were present at ≤0.01 ppm fluroxypyr acid
equivalents in lettuce and turnip tops, and not present in wheat grain.
Free or conjugated fluroxypyr acid was the most commonly observed
residue and fluroxypyr MHE was not detected at levels >0.01 ppm
fluroxypyr acid equivalents.

The proposed use of fluroxypyr in pome fruit orchards consists of
application to the weeds growing around the tree, not the tree foliage.
Therefore the fruit are only exposed via the root system, which may be
exposed to fluroxypyr MHE, fluroxypyr acid, and low levels of the
pyridinol and methoxypyridine soil metabolites.  The confined rotational
crop study results (as discussed above) demonstrated that uptake of
fluroxypyr metabolites would be minimal and residue levels would be low
consisting mostly of fluroxypyr acid (free and conjugated).  The pome
fruit (apple and pear) field trial data indicate that little or no
(≤0.016 ppm) fluroxypyr is present in the fruit following treatment
with the fluroxypyr MHE formulation to the orchard floor at the proposed
application rate.

The petitioner cites that the European Union (EU) has decided to allow
use of fluroxypyr MHE on apples based on data that indicated that
residues are not significantly translocated within the plant and are
generally low in grain, with the bulk of the residue being either
fluroxypyr acid or its conjugate readily extractable with an alkali
methanol procedure.  The EU furthermore added that following hydrolysis
of the ester no other degradative step occurs, and that conjugation is
the route of detoxification in plants.

Conclusions:  The HED ChemSAC (see Minutes of the 1/17/2007 ChemSAC
Meeting) has determined that while OPP usually requires three metabolism
studies in diverse crops, a nature of the residue study on leafy crops
would not yet be needed in this case because fluroxypyr is applied to
the orchard floor and, therefore, significant residues are not expected,
as the confined rotational crop studies demonstrate.  ChemSAC concurred
that the available studies show a consistent metabolic profile, and that
an additional nature of the residue study would not provide significant
new information.  A nature of the residue study waiver was determined
appropriate for pome fruit only with the caveat that the application
rates for pome fruit are comparable to those used for the rotational
crop study.  The confined rotational crop study was conducted at 8.8 oz
ae/A (0.55 lb ae/A) which is consistent with the proposed seasonal rate
on pome fruit (0.5 lb ae/A).

860.1300 Nature of the Residue - Livestock

Residue Chemistry Memo DP# 285871, 8/20/03, M. Xue (PP#9F6050)

  SEQ CHAPTER \h \r 1 The nature of the residue in ruminants and poultry
has been adequately defined.  The residue of concern is fluroxypyr
1-methylheptyl ester and its metabolite fluroxypyr, free and conjugated,
all expressed as fluroxypyr (HED MARC, 4/21/98).

860.1340 Residue Analytical Methods

Enforcement methods:  The GC/MSD Methods GRM 96.02 and 96.03 are the
current enforcement methods for residues of fluroxypyr in/on cereal
grain and ruminant commodities, respectively.  In this method, residues
of fluroxypyr 1-MHE and fluroxypyr are extracted using acidic acetone,
and the extract is made basic with sodium hydroxide to hydrolyze any
fluroxypyr-MHE to the acid.  The extract is acid hydrolyzed at 90 ºC
for 2 hours and subjected to C18 solid phase extraction.  Fluroxypyr
residues are then derivatized with acidified 1-propanol, and the
1-propyl ester derivative is partitioned into isooctane containing
fluroxypyr 1-butyl ester (the internal standard) for GC/MSD analysis.
Residues are reported as fluroxypyr acid equivalents.  The limits of
quantitation range from 0.01 to 0.08 ppm in plant commodities, and 0.01
ppm in animal commodities.

Data collection methods:  The GC/MSD enforcement method (GRM 96.02) for
cereal grains, with modifications, was used for the analysis of samples
from the submitted field trial and processing study associated with this
Summary Document.  Modifications made to the method were minor
(increased amounts of the extraction solvent and reactants).  The
concurrent method recoveries demonstrated that the method was adequate
for data-collection.  The lowest level of method validation (LLMV) for
fluroxypyr and fluroxypyr 1-MHE was 0.010 ppm in pear and apple fruit,
apple wet pomace and apple juice.  The limit of quantitation (LOQ) and
limit of detection (LOD) were also calculated/estimated for each matrix
based on recoveries of samples fortified separately at the LLMV.

Conclusions:  The GC/MSD method used for analysis of samples from the
apple and pear field trials and apple processing study is adequate for
data-collection based on acceptable concurrent method validation
recoveries.  The GC/MSD method is a modification of the established
enforcement method (GRM 96.02) for cereal grain commodities, and is
applicable as an enforcement method for the new uses proposed on pome
fruit and millet.

860.1360 Multiresidue Methods

HED Letter to L. Sawyer of FDA, 9/25/92, G.J. Herndon

Residue Chemistry Memo DP# 285871, 8/20/03, M. Xue (PP#9F6050)

Fluroxypyr was previously tested through FDA’s Multiresidue
Methodology, Protocols C, D, and E.  The results have been published in
the FDA Pesticide Analytical Manual, Volume I.

860.1380 Storage Stability

DER Reference:  47017101.de1.doc, D. Davis, 10/3/07

		47017101.de2.doc, D. Davis, 10/3/07

Residue Chemistry Memo DP# 285871, 8/20/03, M. Xue (PP#9F6050)

There are adequate storage stability data to support the storage
conditions and durations of samples collected from the pome fruit field
trials and apple processing study.  Concurrent storage stability studies
were conducted with each matrix over the study duration.  The results
indicate that residues of fluroxypyr and fluroxypyr 1-MHE are reasonably
stable in/on fortified apple fruit, wet pomace and juice stored frozen
for up to ~5 months, and in/on fortified pear samples stored frozen for
up to ~11 months.

The storage durations and conditions of samples from the crop field
trials and processing study are presented in Table 4.

Table 4.		Summary of Storage Conditions and Durations of Samples from
Crop Field Trial and Processing Studies.

Matrix 	Storage

Temperature

(°C)	Maximum Storage Duration	Interval of Demonstrated Storage
Stability

Apples	-27 to -8	140 days (4.6 months)	4.7 months for fluroxypyr and
fluroxypyr 1-MHE in apples.

Apple, wet pomace	-27 to -8	104 days (3.4 months)	4.6 months for
fluroxypyr and fluroxypyr 1-MHE in apple wet pomace.

Apple, juice	-27 to -8	99 days (3.3 months)	4.9 months for fluroxypyr
and fluroxypyr 1-MHE in apple juice.

Pears	-21 ± 7	305 days (10.0 months)	10.7 months for fluroxypyr and
11.1 months for fluroxypyr 1-MHE in pears.

Conclusions:  There are adequate storage stability data to support the
sample storage conditions and durations of the apple and pear field
trials and apple processing study.

860.1480 Meat, Milk, Poultry, and Eggs

Residue Chemistry Memo DP# 285871, 8/20/03, M. Xue (PP#9F6050)

Livestock dietary burdens

The potential for secondary transfer of fluroxypyr residues of concern
in meat, milk, poultry, and eggs exists because there are livestock
feedstuffs associated with the proposed uses in the current petition.
The livestock dietary burdens of fluroxypyr are presented in Table 5,
and reflect the most recent guidance from HED concerning revisions of
feedstuff percentages in OPPTS 860.1000 Table 1 and constructing
reasonably balanced livestock diets (RBDs).  The calculated dietary
burdens of fluroxypyr residues of concern are 3.8 ppm for beef cattle,
7.6 ppm for dairy cattle, 0.26 ppm for poultry, and 0.016 ppm for swine.

Table 5.    Calculation of Dietary Burdens of Fluroxypyr Residues of
Concern to Livestock.

Feedstuff	Type	% Dry Matter2	% Diet	Recommended Tolerance (ppm)	Dietary
Contribution (ppm)2

Beef Cattle    R: 15%; CC: 75-80 %;  PC: 5-10 %1

barley/millet/oat/wheat hay	R	85	15	20.0	3.53

corn, field, grain/ sorghum, grain, grain	CC	88	45	0.02	0.01

barley grain; wheat grain/milled bypdts	CC	188	30	0.5	0.17

grain, aspirated fractions	CC	85	5	0.6	0.04

untreated	PC	NA	5	NA	--

TOTAL BURDEN	--	--	100	NA	3.8

Dairy Cattle   R: 45%; CC: 45 %;  PC: 10%

barley/millet/oat/wheat hay	R	85	30	20.0	7.05

corn, field, forage	R	40	15	1.0	0.38

barley grain; wheat grain/milled bypdts	CC	88	30	0.5	0.17

corn, field, grain/ sorghum, grain, grain	CC	88	15	0.02	0.003

untreated	PC	NA	10	NA	--

TOTAL BURDEN	--	--	100	--	7.6

Poultry   CC: 75-80 %;  PC: 20-25%  (normally  no R, some exceptions)

corn, field, grain/milled bypdts; sorghum, grain, grain	CC	88	30	0.02
0.006

barley grain; wheat grain/milled bypdts	CC	88	50	0.5	0.25

Untreated	PC 	NA	20	NA	--

TOTAL BURDEN	--	--	100	--	0.26

Swine     CC: 80-85 %;  PC: 15-20%

corn, field, grain/milled bypdts; sorghum, grain, grain	CC	88	55	0.02
0.01

barley grain; wheat grain/milled bypdts	CC	85	30	0.5	0.15

Untreated	PC	NA	15	NA	--

TOTAL BURDEN	--	--	100	--	0.16

	1  R:  Roughage; CC:  Carbohydrate concentrate; PC:  Protein
concentrate.

	2  Contribution = ([tolerance /% DM] X % diet) for beef and dairy
cattle; contribution = ([tolerance] X % 	diet) for poultry and swine.

  SEQ CHAPTER \h \r 1 A cattle feeding study was submitted in
conjunction with PP#7G3541 (memo of 12/31/87, R. Loranger).  Cattle were
fed 20, 200, and 1000 ppm fluroxypyr in the daily diet for 28
consecutive days.  The results are shown below.

Table 6.  Maximum Fluroxypyr Residue Levels Found in Animal Commodities
At Different Feed Dose Levels.

Dose (ppm)	Muscle (ppm)	Fat (ppm)	Kidney (ppm)	Liver (ppm)	Milk (ppm)

0	<0.05	<0.05	<0.05	<0.05	<0.05

20	<0.05	<0.05	0.08	<0.05	<0.05

200	<0.05	0.07	0.63	0.08	0.15

1000	<0.05	0.14	2.12	0.10	0.49

  SEQ CHAPTER \h \r 1 Based on reasonably balanced dietary burdens
calculated above for cattle, residues of fluroxypyr would not be
expected to exceed the current tolerances of:  (i) 0.1 ppm in meat, fat,
and meat byproducts (except kidney); (ii) 0.3 ppm in milk, and (iii) 1.5
ppm in kidney.

A metabolism study on poultry at 10 ppm (>300x the RBDB of 0.026 ppm)
indicates that residues are not expected in poultry and eggs from the
proposed use on millet.  Therefore, no tolerances are needed for poultry
and eggs.

Conclusions:  The proposed use on millet and pome fruit are not expected
to significantly increase the dietary burdens.  There is an adequate
cattle feeding study to support the established fluroxypyr tolerances in
milk, meat, meat byproducts, fat, and kidney.  No tolerances are needed
for poultry and eggs.

860.1500 Crop Field Trials

Pome Fruit (Group 11)

DER Reference:  47017101.de1.doc, D. Davis, 10/3/07

IR-4 has submitted field trial data for fluroxypyr on apples and pears,
the representative commodities of the pome fruit crop group (Group 11).
Twenty pome fruit field trials were conducted in the United States
during the 2001 growing season.  Thirteen apple trials were conducted in
Zones 1 (ME and NY; 2 trials), 2 (NJ and NC; 2 trials), 5 (MI; 3
trials), 9 (CO, 1 trial), 10 (CA; 1 trial) and 11 (ID and WA; 4 trials),
and seven pear trials were conducted in Zones 2 (NJ; 1 trial), 10 (CA; 3
trials) and 11 (ID and WA, 3 trials).

The test formulation used was StaraneTM Herbicide (EPA Reg. No.
62719-286), a 1.5 lb ae/gal emulsifiable concentrate formulation of
fluroxypyr 1-methylheptyl ester.  At each test location, a single
broadcast application of StaraneTM Herbicide was made to the orchard
floor at a nominal rate of 0.50 lb ae/A (1x the maximum proposed
seasonal rate).  Application was made during the tree’s fruiting stage
using ground equipment, without an adjuvant.  Mature apples or pears
were harvested 13-15 days after application.

The collected pome fruit samples were analyzed for fluroxypyr using
GC/MSD method GRM 96.02.  The method converts the methylheptyl ester
form of fluroxypyr to the acid, and the results are reported as the acid
equivalent.  The lowest level of method validation for fluroxypyr and
fluroxypyr 1-MHE was 0.01 ppm in apples and pears.  The adequacy of the
method for data collection was verified by fortifying untreated samples
of apples and pears with fluroxypyr and fluroxypyr-MHE at 0.01, 0.02,
and 0.1 ppm.  Method recoveries were well within the acceptable range of
70-120% from all fortified samples.  It is noted that Method GRM 96.02
is the current enforcement method for fluroxypyr residues in plants.

The maximum storage durations of crop samples, from harvest to analysis,
were 140 days (4.6 months) for apples and 305 days (10.0 months) for
pears.  Sample storage conditions and durations are supported by an
adequate concurrent storage stability study on apples and pears.

A summary of residue data from the pome fruit field trials is presented
in Table 7.  Residues of fluroxypyr were below the LLMV (<0.01 ppm)
in/on all apple and pear samples, except for one pear sample which bore
quantifiable residues at 0.016 ppm, harvested 13-15 days following
treatment to the orchard floor at 0.478-0.525 lb ae/A.

Table 7.    Summary of Residue Data from Pome Fruit Field Trials with
Fluroxypyr.

Commodity	Total Applic. Rate

 (lb ae/A)	PHI (days)	Residue Levels  (ppm)

	No. of samples	Min.	Max.	HAFT1	Median

(STMdR)	Mean

(STMR)	Std. Dev.

Proposed Use Pattern:   Maximum Seasonal Rate of 0.5 lb ae/A with a
14-day PHI.

Apple, fruit	0.478-0.525	13-15	26	<0.01	<0.01	<0.01	NA 2	NA	NA

Pear, fruit	0.483-0.505	13-14	14	<0.01	0.016	<0.013	0.01	0.01	0.002

1  HAFT = Highest Average Field Trial.

2  NA = not applicable.

Conclusions:  The submitted residue data for apples and pears, the
representative commodities of Pome Fruit (Crop Group 11), are adequate
to fulfill data requirements.  The number and locations of crop field
trials are in accordance with OPPTS Guideline 860.1500.  The trials
reflect the proposed use pattern.  The available field trial data will
support the proposed tolerance for the residues of fluroxypyr in/on pome
fruit at 0.02 ppm.

Millet

Residue Chemistry Memo DP#s 174075 & 174388, 9/29/92, G.J. Herndon
(PP#2G4066)

No residue data were submitted to support the proposed RAC tolerances
for millet.  IR-4 has requested that the available residue data for
barley, oats, and wheat be translated to millet.  Fluroxypyr tolerances
are currently established for the grain (0.5 ppm), forage (12.0 ppm),
and hay (20.0 ppm) of barley, oat, and wheat.  Residue data used for
tolerance establishment were reviewed in PP#2G4066 (DP#s 174075 &
174388, 9/29/92, G.J. Herndon).

The Agency typically allows translation of residue data among members of
the same crop group with identical use pattern.  The proposed use
pattern on millet (see Table 3) specifies a maximum seasonal rate of
0.25 lb ae/A with a PHI of 7 days for hay or silage.  The registered
uses of barley, oats, and wheat specify a maximum seasonal rate of 0.25
lb ae/A with PHIs of 14 days for hay and 40 days for grain and straw.

Conclusions:  The available data for barley, oat, and wheat may be
translated to support the proposed use of fluroxypyr on millet pending
label revision to specify PHIs of 14 days for hay and 40 days for grain
and straw.

860.1520 Processed Food and Feed

Apple

DER Reference:  47017101.de2.doc

IR-4   SEQ CHAPTER \h \r 1 has submitted a processing study for
fluroxypyr on apples.  Samples used for processing were generated from a
trial conducted in WA during the 2001 growing season.  Apples were
harvested 14 days following a single broadcast spray application of
StaraneTM Herbicide (EPA Reg. No. 62719-286), a 1.5 lb ae/gal
emulsifiable concentrate formulation of fluroxypyr 1-methylheptyl ester
at 0.512 lb ae/A (~1x the nominal field trial rate).  The collected
apple samples were processed into wet pomace and juice using simulated
commercial practices.

Samples of apples and its processed commodities were analyzed for
fluroxypyr using GC/MSD method GRM 96.02.  The LLMV for fluroxypyr and
fluroxypyr 1-MHE was 0.01 ppm in apple matrices.

The maximum storage durations of crop samples, from harvest/processing
to analysis, were 108 days (3.6 months) for apples (RAC) and 99-104 days
(~3 months) for processed apple wet pomace and juice.  Storage
conditions and durations are supported by an adequate concurrent storage
stability study on apples, wet pomace and, juice.

Residues of fluroxypyr were below the LLMV (<0.01 ppm) in both the
treated RAC and the processed fractions (wet pomace and juice);
therefore, processing factors for fluroxypyr in apples could not be
calculated.  The maximum theoretical concentration factor for apple is
>14x (OPPTS 860.1520, Table 1, experimental factor).

Conclusions:  The submitted apple processing study is considered
adequate to support the proposed use.  While whole fruit samples treated
at 1X the proposed use pattern did not contain residues above the method
LLMV, given that this is a use to the orchard floor and confined
rotational crop studies do not show significant uptake of residues, it
is unlikely that residues will be detectable in whole fruit even from an
exaggerated rate study.  The submitted study is adequate to demonstrate
that residues in wet apple pomace and apple juice are not likely to
exceed the established tolerance for the apple RAC.

  SEQ CHAPTER \h \r 1 860.1650 Submittal of Analytical Reference
Standards

Analytical standards for fluroxypyr 1-MHE and its metabolite fluroxypyr
are currently available in the EPA National Pesticide Standards
Repository (personal communication with Diane Raines, ACB, 5/25/07).
However, the standard for fluroxypyr expired 7/2007.  In addition,
standards for fluroxypyr 1-propyl ester and 1-butyl ester are not
available at the repository; these standards, used for quantiation as
the derivative and internal standard, were requested by the Analytical
Chemistry Branch in conjunction with the method PMV results (DP# 253504,
2/25/99, W. Donovan).

The registrant must either recertify the lot in the repository for the
fluroxypyr standard and send in an updated certificate of analysis
(COA), or submit a new standard (different lot #) if the previous lot
will not be recertified.  If a new COA is being submitted, it should be
faxed to the repository at<PHONE_NUMBER>.

Analytical reference standards of fluroxypyr 1-propyl ester and 1-butyl
ester must be supplied and supplies replenished as requested by the
Repository.  The reference standards should be sent to the Analytical
Chemistry Lab, which is located at Fort Meade, to the attention of
either Theresa Cole or Frederic Siegelman at the following address:

	USEPA

	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP

	701 Mapes Road

	Fort George G. Meade, MD  20755-5350

(Note that the mail will be returned if the extended zip code is not
used.)

860.1850 Confined Accumulation in Rotational Crops

Residue Chemistry Memo DP# 245073, 4/9/98, W. Donovan

Residue Chemistry Memo DP# 285871, 8/20/03, M. Xue (PP#9F6050)

A previously submitted confined rotational crop study (MRID 44080350)
was considered in conjunction with the field corn, sweet corn, sorghum
and grasses petition (PP#9F6050).  The study was conducted at 8.8 oz
ae/A (0.55 lb ae/A; 2.2x the maximum seasonal rate for crops which may
be rotated), and rotational crops wheat, lettuce, and turnips were
planted in the treated soil 30, 120 and 365 days after treatment; corn
was also planted at the 365-day plantback interval.  Fluroxypyr was the
free residue most frequently observed in the 30-day samples.  No free
metabolites were detected above 0.01 ppm in the rotated crop matrices by
the 120-day PBI.  Other metabolites detected were the methoxypyridine
and pyridinol at <0.01 ppm fluroxypyr acid equivalents and two unknowns
present as major residues in 30-day samples were determined conjugates
of fluroxypyr.  The HED MARC has determined that the residue of concern
in rotated crops is fluroxypyr 1-MHE and its metabolite fluroxypyr, free
and conjugated, all expressed as fluroxypyr (DP# 277058, 5/19/98, W.
Donovan).

860.1900 Field Accumulation in Rotational Crops

Field accumulation data for rotational crops are not required based on
the results of confined rotational crop studies.  The new uses proposed
for millet (a rotatable crop) are at the same maximum seasonal rate as
uses established for barley, oats and wheat; therefore there is no
change in the previous decision not to require limited field data for
rotational crops.

The most recently approved master label for StaraneTM Herbicide (EPA
Reg. No. 62719-286; dated 5/28/03) specifies that only crops listed on
the label (or approved supplemental labels) may be planted within 120
days following application.

860.1550 Proposed Tolerances

In PP#6E7168, the proposed tolerance expression is in terms of the
combined residues of the herbicide fluroxypyr 1-methylheptyl ester
[1-methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate]
and its metabolite fluroxypyr
[((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid].  The
proposed tolerance expression is consistent with the fluroxypyr
tolerances established in 40 CFR §180.535.

The tolerance spreadsheet in the Agency’s Guidance for Setting
Pesticide Tolerances Based on Field Trial Data was not utilized for
determining an appropriate tolerance level for the RACs of pome fruit
because a large number (>25%) of treated samples bore residues below the
LOQ.

Adequate field trial data are available for pome fruit.  The apple and
pear data support the proposed tolerance for pome fruit.

No field trial data were submitted for millet.  The available data for
barley, oat, and wheat may be translated to support the proposed use of
fluroxypyr on millet pending label revision to specify PHIs of 14 days
for hay and 40 days for grain and straw.

Pending submission of a revised Section B, the available barley, oat and
wheat data may be translated to millet and will support the proposed
tolerances for millet, proso millet, and pearl millet.

A summary of the recommended tolerances for the crop commodities
discussed in this Summary Document is presented in Table 9.  The
petitioner should submit a revised Section F reflecting the recommended
tolerances and commodity definitions presented in Table 9, below.

Table 9. 	Tolerance Summary for Fluroxypyr.

Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Comments;
Correct Commodity Definition1

Pome, fruit, group 11	0.02	0.02	Fruit, pome, group 11

Millet, grain	0.5	0.5

	Millet, forage	12.0	12.0

	Millet, hay	20.0	20.0

	Millet, proso, grain	0.5

This use is covered by the millet grain tolerance.  A separate tolerance
for proso millet grain is not required

Millet, proso, straw	12.0	12.0

	Millet, proso, forage	12.0

This use is covered by the millet forage tolerance.  A separate
tolerance for proso millet forage is not required.

Millet, proso, hay	20.0

This use is covered by the millet hay tolerance.  A separate tolerance
for proso millet hay is not required.

Millet, pearl, grain	0.5

This use is covered by the millet grain tolerance.  A separate tolerance
for pearl millet grain is not required.

Millet, pearl, forage	12.0

This use is covered by the millet forage tolerance.  A separate
tolerance for pearl millet forage is not required.

Millet, pearl, hay	20.0

This use is covered by the millet hay tolerance.  A separate tolerance
for pearl millet hay is not required.

1Recommendations on tolerance definitions/need for tolerances from email
communication from Bernard Schneider on 6/25/07.

References

DP#:		174075 and 174388

Subject:	PP#2G4066.  Temporary Tolerance Petition and Experimental Use
Permit for Use of Fluroxypyr (Methylhepty Ester) on Barley, Oats, and
Wheat; 062719-EUP-RI.  Evaluation of Analytical Method and Residue Data.
CBTS#:  9300, 9620

From:		G.J. Herndon

To:		J. Miller/D. Kenny and A. Kocialski

Dated:		09/29/92

MRIDs:	42164503-06 and 42137344-55

DP#:		191904

Subject:	PP#2G4066.  Temporary Tolerance Petition and Experimental Use
Permit for Use of Fluroxypyr (Methylhepty Ester) on Barley, Oats, and
Wheat; 062719-EUP-RI.  Amendment of 4/19/93 Addressing Deficiencies in
the Goat Metabolism Study.  CBTS# 11961

From:		G.J. Herndon

To:		J. Miller/D. Kenny and A. Kocialski

Dated:		10/06/93

MRIDs:	42739301

DP#:		245073

Subject:	Fluroxypyr 1-methylhepty ester.  Issues to be Presented to the
HED Metabolism Assessment Review Committee.  Chemicals 128968 and
128959.

From:		W. Donovan

To:		HED Metabolism Assessment Review Committee Members

Dated:		04/09/98

MRIDs:	None

DP#:		277058

Subject:	Fluroxypyr 1-methylhepty ester.  Chemicals 128968 and 128959.
Results of the Metabolism Assessment Review Committee Meeting Held
21-APR-1998.

From:		W. Donovan

To:		G. Kramer and Metabolism Assessment Review Committee

Dated:		05/19/98

MRIDs:	None

DP#:		331225

Subject:	Fluroxypyr.  Petition for Tolerance to Support Use on Dry Bulb
Onions, Including Garlic and Shallots.  Summary of Analytical Chemistry
and Residue Data.  Petition Number:  3E6775.

From:		D. Davis

To:		M. Clock-Rust/B. Madden

Dated:		08/02/06

MRIDs:	46109601

  SEQ CHAPTER \h \r 1 Attachment:

International Residue Limit Status sheet

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:

((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy) acetic acid	Common
Name:

Fluroxypyr

	X Proposed tolerance

( Reevaluated tolerance

( Other	Date:  5/23/07

Codex Status (Maximum Residue Limits)	U. S. Tolerances

X No Codex proposal step 6 or above

( No Codex proposal step 6 or above for the crops requested	Petition
Number:  PP#6E7168

DP#:  336178

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Residue definition (step 8/CXL): N/A	Reviewer/Branch:  P. Deschamp/RAB3

	Residue definition:  Residues of fluroxypyr 1-methylheptyl ester
[1-methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate]
and its metabolite fluroxypyr
[((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid], free and
conjugated, all expressed as fluroxypyr

Crop (s)	MRL (mg/kg)	Crop(s) 	Tolerance (ppm)

Pome, fruit, group 11	0.02

Millet, grain	0.5

Millet, forage	12.0

Millet, hay	20.0

Millet, proso, grain	0.5

Millet, proso, straw	12.0

Millet, proso, forage	12.0

Millet, proso, hay	20.0

Millet, pearl, grain	0.5

Millet, pearl, forage	12.0

Millet, pearl, hay	20.0

Limits for Canada	Limits for Mexico

X No Limits

No Limits for the crops requested	X No Limits

No Limits for the crops requested

Residue definition:  N/A

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.2

	Notes/Special Instructions:  S.Funk, 05/24/2007

Page   PAGE  1  of   NUMPAGES  19

Fluroxypyr                                 Summary of Analytical
Chemistry and Residue Data	DP# 336178


[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Proposed Rules]
[Pages 15517-15519]
[FR Doc No: 2018-07433]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0286; Product Identifier 2018-CE-008-AD]
RIN 2120-AA64

Airworthiness Directives; Pacific Aerospace Limited Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain

Pacific Aerospace Limited Model 750XL airplanes. This proposed AD
results from mandatory continuing airworthiness information (MCAI)
originated by an aviation authority of another country to identify and
correct an unsafe condition on an aviation product. The MCAI describes
the unsafe condition as airplane sound insulation materials attached to
the aft face of the firewall not complying with the applicable burn
testing criteria for materials on the cabin side of the firewall. We
are issuing this proposed AD to require actions to address the unsafe
condition on these products.

DATES: We must receive comments on this proposed AD by May 29, 2018.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Pacific Aerospace Limited, Airport Road, Hamilton, Private Bag 3027,
Hamilton 3240, New Zealand; phone: +64 7843 6144; fax: +64 843 6134;
email: [email protected]; internet: www.aerospace.co.nz. You may
review this referenced service information at the FAA, Policy and
Innovation Division, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call (816)
329-4148.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0286; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this proposed AD, the regulatory evaluation, any comments received, and
other information. The street address for Docket Operations (telephone
(800) 647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Mike Kiesov, Aerospace Engineer, FAA,
Small Airplane Standards Branch, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2018-0286;
Product Identifier 2018-CE-008-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this proposed AD. We will consider
all comments received by the closing date and may amend this proposed
AD because of those comments.
    We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The Civil Aviation Authority of New Zealand (CAA), has issued DCA/
750XL/27A, dated March 1, 2018 (referred to after this as ``the
MCAI''), to correct an unsafe condition for Pacific Aerospace Limited
Model 750XL airplanes. The MCAI states:

    The sound insulation material on the aft face of the firewall
must comply with the applicable burn test criteria specified in FAR
23.853(f).
    Inspect the aft face of the firewall and determine if sound
insulation material is installed per the instructions in Pacific
Aerospace Mandatory Service Bulletin (MSB) PACSB/XL/095 issue 1,
dated 21 December 2017, or later approved revision.
    If a layer of black foam insulating material is found covering
the firewall, then remove the material per the instructions in MSB
PACSB/XL/095 before further flight.

You may examine the MCAI on the internet at http://www.regulations.gov
by searching for and locating Docket No. FAA-2018-0286.

Related Service Information Under 1 CFR Part 51

    Pacific Aerospace Limited has issued Pacific Aerospace Service
Bulletin PACSB/XL/095, Issue 1, dated December 21, 2017. The service
information describes procedures for inspection of the airplane sound
insulation attached to the aft face of the firewall and removal if
necessary. This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Costs of Compliance

    We estimate that this proposed AD will affect 22 products of U.S.
registry. We also estimate that it would take about 1 work-hour per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $1,870, or $85 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 8 work-hours, for a cost of $680 per product. We have no way
of determining the number of products that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C.

In accordance with that order, issuance of ADs is normally a function
of the Compliance and Airworthiness Division, but during this
transition period, the Executive Director has delegated the authority
to issue ADs applicable to small airplanes, gliders, balloons,
airships, domestic business jet transport airplanes, and associated
appliances to the Director of the Policy and Innovation Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

Pacific Aerospace Limited: Docket No. FAA-2018-0286; Product
Identifier 2018-CE-008-AD.

(a) Comments Due Date

    We must receive comments by May 29, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Pacific Aerospace Limited Model 750XL
airplanes, all serial numbers up to and including 215, certificated
in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 54: Nacelles/
Pylons.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and address an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as airplane sound
insulation materials attached to the aft face of the firewall not
complying with the applicable burn testing criteria for materials on
the cabin side of the firewall. We are issuing this AD to prevent
the spread of fire into the cabin in case of an engine fire.

(f) Actions and Compliance

    Unless already done, do the following actions in paragraphs
(f)(1) and (2) of this AD:
    (1) Within the next 90 days after the effective date of this AD,
inspect the aft face of the firewall and determine if the sound
insulation material is installed per the Inspection Instructions in
Pacific Aerospace Service Bulletin PACSB/XL/095, Issue 1, dated
December 21, 2017.
    (2) If a layer of black foam insulating material is found
covering the firewall during the inspection required in paragraph
(f)(1) of this AD, before further flight, remove the material per
the Accomplishment Instructions in Pacific Aerospace Service
Bulletin PACSB/XL/095, Issue 1, dated December 21, 2017.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Small Airplane Standards Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Mike Kiesov, Aerospace Engineer,
FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas
City, Missouri 64106; telephone:<PHONE_NUMBER>; fax: (816) 329-
4090; email: [email protected]. Before using any approved AMOC on
any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, Small Airplane
Standards Branch, FAA; or the Civil Aviation Authority of New
Zealand (CAA).

(h) Related Information

    Refer to MCAI CAA AD DCA/750XL/27A, dated March 1, 2018; and
Pacific Aerospace Service Bulletin PACSB/XL/095, Issue 1, dated
December 21, 2017, for related information. You may examine the MCAI
on the internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2018-0286. For service information related
to this AD, contact Pacific Aerospace Limited, Airport Road,
Hamilton, Private Bag 3027, Hamilton 3240, New Zealand; phone: +64
7843 6144; fax: +64 843 6134; email: [email protected];
internet: www.aerospace.co.nz. You may review this referenced
service information at the FAA, Policy and Innovation Division, 901
Locust, Kansas City, Missouri 64106. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Kansas City, Missouri, on April 4, 2018.
Melvin J. Johnson,
Deputy Director, Policy & Innovation Division, Aircraft Certification
Service.
[FR Doc. 2018-07433 Filed 4-10-18; 8:45 am]
 BILLING CODE 4910-13-P