Plant # Owner City State Elevation Level ( FT) 1 TempleInland Shippenville PA 1388 2 Emerald Forest Eugene OR 419 15 Roseburg Forest Weed CA 3466 18 Roseburg Forest OR 19 Roseburg Forest Riddle OR 705 21 Smurfit Newsp Philomath OR 280 22 Smurfit Newsp Sweet Home OR 525 24 Timber Produc White City OR 1305 25 Coastal Lumb Havana FL 245 33 K Ply. Incorpo Port Angeles WA 32 37 Rodman Indus Marinette WI 598 38 Scotch Plywoo Fulton AL 234 39 Southern Vene Fitzgerald GA 338 41 Webb Furnitur Galax VA 2382 45 Allegheny MD Mt. Jewett PA 2240 47 Bassett Fiberb Bassett VA 760 48 Bessemer Plywood Bessemer MI 1432 64 Champion Inte Camden TX 282 65 Champion Inte Corrigan TX 233 78 Georgia Pacific Vienna GA 338 81 Georgia Pacific Warm Spring GA 930 86 Georgia Pacific Duluth MN 980 93 Georgia Pacific Taylorsville MS 340 95 Georgia Pacific Conway NC 100 97 Georgia Pacific Whiteville NC 101 99 Georgia Pacific Lebanon OR 346 100 Georgia Pacific Catawba SC 570 101 Georgia Pacific Holly Hill SC 108 106 107 Georgia Pacific Emporia VA 119 109 Georgia Pacific Phillips WI 1480 110 Georgia Pacific Superior WI 642 111 Georgia Pacific Mt. Hope WV 1661 112 Hood Industrie Beaumont MS 95 113 Hood Industrie Wiggins MS 370 115 Inca Presswoo Dover OH 898 118 Springhill Woo Springhill LA 184 133 J. M. Huber Co Spring City TN 773 138 Louisiana Pacific Arcata CA 33 141 Louisiana Pacific Logansport LA 204 144 Louisiana Pacific Newberry MI 788 146 Louisiana Pacific Two Harbor MN No Elevation Level 156 Norbord MS Guntown MS 384 157 Norbord Indus Deposit NY 991 159 Plum Creek Kalispell MT 2954 160 Potlatch Corpo Post Falls ID 2200 162 Potlatch Corpo St. Maries ID 2216 164 Potlatch Corpo Cook MN 1306 165 Potlatch Corpo Grand Rapids MN 1290 166 Medite Divisio Medford OR 1383 173 Stimson Lumb Gaston OR 195 180 Temple Inland Pineland TX 250 183 Union Camp C Chapman AL 265 Plant # Owner City State Elevation Level ( FT) 184 Union Camp C Franklin VA 25 188 Weyerhaeuse Adel GA 240 189 Weyerhaeuse Grayling MI 1137 190 Weyerhaeuse Moncure NC 210 194 Weyerhaeuse Marshfield WI 1280 209 Willamette Ind Sweet Home OR 525 220 Evanite Fiber Corvallis OR 225 222 Freres Lumbe Mill City OR 827 224 Hambro Fores Crescent CA 44 230 Murphy Plywo Sutherlin OR 540 235 Ponderosa Pro Albuquerque NM 4955 237 Simpson Timb Shelton WA 6 238 Superior Lumb Glendale OR 1423 431 Trus Joist Mac Eugene OR 419 152B Louisiana Pac Silsbee TX 81 23B Timber Produc Medford OR 1383 58A Broyhill Furnit Lenior NC No Listing


[Federal Register Volume 81, Number 81 (Wednesday, April 27, 2016)]
[Notices]
[Page 24812]
[FR Doc No: 2016-09891]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2012-0691; FRL-9945-32-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Mercury Cell Chlor-Alkali Plants
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``NESHAP for Mercury Cell Chlor-
Alkali Plants (40 CFR part 63, subpart IIIII) (Renewal)'' (EPA ICR No.
2046.08, OMB Control No. 2060-0542), to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of
the ICR, which is currently approved through April 30, 2016. Public
comments were previously requested via the Federal Register (80 FR
32116) on June 5, 2015 during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An Agency may neither conduct nor sponsor and a
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before May 27, 2016.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2012-0691, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW., Washington, DC 20460; and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: Owners and operators of affected facilities are required
to comply with reporting and record keeping requirements for the
general provisions of 40 CFR part 63, subpart A, as well as for the
specific requirements at 40 CFR part 63, subpart IIIII. This includes
submitting initial notification reports, performance tests and periodic
reports and results, and maintaining records of the occurrence and
duration of any startup, shutdown, or malfunction in the operation of
an affected facility, or any period during which the monitoring system
is inoperative. These reports are used by EPA to determine compliance
with these standards.
    Form Numbers: None.
    Respondents/affected entities: Mercury cell chlor-alkali plants.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart IIIII).
    Estimated number of respondents: 2 (total).
    Frequency of response: Initially and semiannually.
    Total estimated burden: 3,760 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $394,000 (per year), which includes in
$16,400 annualized capital/startup and/or operation & maintenance
costs.
    Changes in the estimates: There is a small adjustment increase in
the respondent labor hours as currently identified in the OMB Inventory
of Approved Burdens. The increase is due to a change in assumption. In
this ICR, we assume all existing sources will take some time each year
to re-familiarize themselves with the regulatory requirements.

Courtney Kerwin,
Acting-Director, Collection Strategies Division.
[FR Doc. 2016-09891 Filed 4-26-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 167 (Wednesday, September 1, 2021)]
[Notices]
[Pages 49035-49037]
[FR Doc No: 2021-18892]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0860]

Psychopharmacologic Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Psychopharmacologic Drugs
Advisory Committee. The general function of the committee is to provide
advice and recommendations to FDA on regulatory issues. The meeting
will be open to the public. FDA is establishing a docket for public
comment on this document.

DATES: The meeting will be held on November 4, 2021, from 10 a.m. to 4
p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings

may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2021-N-0860. The docket will close on November
3, 2021. Submit either electronic or written comments on this public
meeting by November 3, 2021. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before November 3, 2021. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of November 3, 2021. 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.
    Comments received on or before October 21, 2021, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

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-0860 for ``Psychopharmacologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments.'' 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.'' FDA 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 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 the 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: Joyce Frimpong, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-7973, Fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. The committee
will discuss new drug application (NDA) 214812, for carbetocin nasal
spray, submitted by Levo Therapeutics, Inc., for the proposed treatment
of hyperphagia, anxiety, and distress behaviors associated with Prader-
Willi syndrome.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference meeting room will be available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.

    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before October 21, 2021, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1:30 p.m. and 2:30 p.m. Eastern Time. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before October 13, 2021.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by October 14, 2021.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Joyce Frimpong (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: August 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18892 Filed 8-31-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: April 17, 2006 (Volume 71, Number 73)]
[Notices]
[Page 19762]
[DOCID:fr17ap06-107]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Requested

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension:
    Rule 15g-6, SEC File No. 270-349 and OMB Control No. 3235-0395.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget requests for extension of the previously approved collection
of information discussed below.

Rule 15g-6--Account Statements for Penny Stock Customers

    Rule 15g-6 (17 CFR 240.15g-6) under the Securities Exchange Act of
1934 requires brokers and dealers that sell penny stocks to their
customers to provide monthly account statements containing information
with regard to the penny stocks held in customer accounts. The
information is required to be provided to customers of broker-dealers
that effect penny stock transactions in order to provide those
customers with information that is not now publicly available. Without
this information, investors would be less able to protect themselves
from fraud and to make informed investment decisions.
    The staff estimates that there are approximately 240 broker-dealers
that are subject to the rule. The staff estimates that the firms
affected by the rule will, at any one time, have approximately 150 new
customers with whom they have effected transactions in penny stocks,
each of whom would receive a maximum of 12 account statements per year,
for a total of 1,800 account statements annually for each firm (150
customers x 12 account statements/customer). The staff estimates that a
broker-dealer would expend approximately three minutes in processing
the information required for each account statement. Accordingly, the
estimated average annual burden would equal 90 hours (1,800 account
statements x 3 minutes/60 minutes = 90 hours), and the estimated
average total burden would equal 21,600 hours (90 hours x 240).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Written comments regarding the above information should be directed
to the following persons: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or by sending an e-mail to:
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief

Information Officer, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, Virginia 22312, or send
an e-mail to<EMAIL_ADDRESS>Comments must be submitted to the
Office of Management and Budget within 30 days of this notice.

    Dated: April 6, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. E6-5684 Filed 4-14-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 225 (Friday, November 26, 2021)]
[Notices]
[Pages 67507-67509]
[FR Doc No: 2021-25755]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93629; File No. SR-NYSE-2021-53]

Self-Regulatory Organizations; New York Stock Exchange LLC; Order
Approving of a Proposed Rule Change To Amend the Shareholder Voting
Requirement Set Forth in Section 312.07 of the NYSE Listed Company
Manual

November 19, 2021.

I. Introduction

    On September 15, 2021, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend Section 312.07 of the NYSE Listed Company
Manual (``Manual'') to address the calculation of votes cast where
shareholder approval is required. The proposed rule change was
published for comment in the Federal

Register on October 5, 2021.\3\ The Commission received no comment
letters on the proposed rule change. This order approves the proposed
rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 93192 (September 29,
2021), 86 FR 55071 (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposal

    The Exchange proposes to amend Section 312.07 of the Manual to
address the calculation of ``votes cast'' when a matter requires
shareholder approval, particularly as the calculation relates to
abstention votes.\4\ Section 312.07 of the Manual currently provides
that where shareholder approval is a prerequisite to the listing of any
additional or new securities of a listed company, or where any matter
requires shareholder approval, the minimum vote which will constitute
shareholder approval for such purposes is defined as approval by a
majority of votes cast on a proposal in a proxy bearing on the
particular matter.\5\ The Exchanges states that the text of Section
312.07 of the Manual does not specifically address a listed company's
treatment of abstentions in the company's calculation of votes cast by
shareholders.\6\ However, the Exchange states that it has historically
advised companies that abstentions should be treated as votes cast for
purposes of Section 312.07 of the Manual.\7\ According to the Exchange,
under that approach a proposal is deemed approved under Section 312.07
of the Manual only if the votes in favor of the proposal exceed the
aggregate of the votes cast against the proposal plus abstentions.\8\
The Exchange states that its current treatment of abstentions has
caused confusion among listed companies because the corporate laws of
many states, including Delaware, allow companies to include in their
governing documents that votes cast for purposes of a shareholder vote
includes yes and no votes--but not abstentions--such that a proposal
succeeds if the votes in favor exceed the votes cast against.\9\
---------------------------------------------------------------------------

    \4\ See Notice, supra note 3, 86 FR 55072.
    \5\ According to the Exchange, shareholder approval is required
for equity compensation plans under Sections 303A.08 of the Manual
(``Shareholder Approval of Equity Compensation Plans'') and in the
specific situations set out in 312.03 of the Manual (``Shareholder
Approval''). See Id. The Exchange also notes that Item 21(b) of
Schedule 14A requires companies soliciting proxies to disclose the
method by which votes will be counted, including the treatment and
effect of abstentions and broker non-votes under applicable state
law as well as the company's charter and bylaw provisions. See Id.
    \6\ See Notice, supra note 3, at 55072.
    \7\ See Id.
    \8\ See Id.
    \9\ See Id. The Exchange added that, consistent with those state
laws, many public companies have bylaws indicating that abstentions
are not treated as votes cast. See Id.
---------------------------------------------------------------------------

    To avoid further confusion, the Exchange proposes to amend Section
312.07 to provide that with respect to a matter that requires
shareholder approval subject to the minimum vote required for such
shareholder approval under Section 312.07, a company must calculate the
votes cast in accordance with its own governing documents and any
applicable state law.\10\ The Exchange believes that this treatment of
abstentions will avoid any complications engendered among issuers and
shareholders when different voting standards are applied under the
Exchange rule, a company's governing documents, and/or applicable state
laws.\11\
---------------------------------------------------------------------------

    \10\ See Id. The Exchange notes that while Nasdaq is silent on
the treatment of abstentions in its rules, Nasdaq published a FAQ
stating that companies must calculate voting in accordance with
their own governing documents and applicable state law. See Id.
    \11\ See Id.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\12\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\13\ which
requires, among other things, that the rules of a national securities
exchange be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest; and are not designed to permit unfair discrimination
between customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \12\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange is proposing to amend Section 312.07 of the Manual to
make clear how to calculate the votes cast when any matter requires
shareholder approval to be approved by a majority of votes cast under
Section 312.07, particularly to address the calculation as it relates
to abstention votes. As described above, the Exchange is proposing to
amend Section 312.07 of the Manual to provide that for purposes of
calculating shareholder approval, a company must calculate the votes
cast in accordance with its governing documents and any applicable
state law.\14\ The Exchange's proposal, as it states in its filing,
does not prescribe a particular way to calculate votes cast under
Section 312.07 of the Manual but rather allows a listed company to rely
on its governing documents and state law and is a change from the
Exchange's historical interpretation on how to calculate abstentions
for purposes of votes cast under Section 312.07 of the Manual. While
the proposed amendment to Section 312.07 of the Manual does not address
the treatment of abstentions explicitly, the Commission believes the
proposed changes to Section 312.07 of the Manual provides clear
guidance to a listed company that the company's own governing documents
and the state law applicable to such listed company must govern the way
that a company calculates votes cast on a matter for purposes of
meeting the minimum vote requirements under the Exchange's rule. As
such, the proposed rule language will make clear that the listed
company's own governing documents and applicable state law also will
govern how a listed company should count abstentions. As a result, the
Commission believes that the proposed amendment is consistent with
Section 6(b)(5) of the Act because it will add clarity to the
Exchange's rules and help eliminate any confusion about what authority
governs the treatment of votes cast in general and abstentions in
particular, including the possibility that the Exchange's own guidance
about the treatment of abstentions might conflict with the treatment of
abstentions under the listed company's governing documents or state law
applicable to such listed company.
---------------------------------------------------------------------------

    \14\ The Exchange noted that Nasdaq has an FAQ that is also
consistent with this approach. See supra note 10.
---------------------------------------------------------------------------

    Finally, by setting forth in the Exchange's rules that corporate
documents and applicable state law should be relied on by all listed
companies and shareholders in determining how votes cast are
calculated, including the treatment of abstentions, for purposes of
determining whether a matter meets the minimum vote requirements (i.e.,
``a majority of votes cast'') of Section 312.07, the proposal should
provide transparency to

market participants consistent with the Act.\15\
---------------------------------------------------------------------------

    \15\ Shareholders should have access to a company's governing
documents that indicate how abstentions are treated under the
applicable voting standard, such as articles of incorporation and
bylaws, as they are required to be filed as exhibits under Item 601
of Regulation S-K for domestic issuers and under Form 20-F for
foreign private issuers. See also supra note 5 and Item 21 of
Schedule 14A that applies to domestic issuers.
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\16\ that the proposed rule change (SR-NYSE-2021-53) be, and hereby
is, approved.
---------------------------------------------------------------------------

    \16\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-25755 Filed 11-24-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 202 (Friday, October 18, 2013)]
[Notices]
[Pages 62347-62348]
[FR Doc No: 2013-24505]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2387-002]

The City of Holyoke Gas & Electric Department; Notice of Intent
To File License Application, Filing of Pre-Application Document, and
Approving Use of the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 2387-002.
    c. Date Filed: August 26, 2013.
    d. Submitted By: City of Holyoke Gas & Electric Department.
    e. Name of Project: Holyoke No. 2 Hydroelectric Project.
    f. Location: Between the first and second level canals on the
Holyoke Canal System adjacent to the Connecticut River, in the City of
Holyoke in Hampden County, Massachusetts. The project does not occupy
federal land.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Paul Ducheney, Superintendent,
Holyoke Gas & Electric, 99 Suffolk Street, Holyoke, MA 01040; (413)
536-9340<EMAIL_ADDRESS>    i. FERC Contact: Adam Beeco at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Holyoke Gas and Electric filed its request to use the
Traditional Licensing Process on August 26, 2013. Holyoke Gas and
Electric provided public notice of its request on September 1, 2013. In
a letter dated October 9, 2013, the Director of the Division of
Hydropower Licensing approved Holyoke Gas and Electric's request to use
the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with:
(a) The U.S. Fish and Wildlife Service and/or NOAA Fisheries under
section 7 of the Endangered Species Act and the joint agency
regulations thereunder at 50 CFR, Part 402; (b) NOAA Fisheries under
section 305(b) of the Magnuson-Stevens Fishery Conservation and
Management Act and implementing regulations at 50 CFR 600.920; and (c)
the Massachusetts State Historic Preservation Officer, as required by
section 106, National Historical Preservation Act, and the implementing
regulations of the Advisory Council on Historic Preservation at 36 CFR
800.2.
    l. With this notice, we are designating Holyoke Gas and Electric as
the Commission's non-federal representative for carrying out informal
consultation, pursuant to section 7 of the Endangered Species Act and
section 106 of the National Historic Preservation Act.
    m. Holyoke Gas and Electric filed a Pre-Application Document (PAD)
and a proposed process plan and schedule with the Commission, pursuant
to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in paragraph h.
    o. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: October 9, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-24505 Filed 10-17-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 61 (Thursday, March 29, 2012)]
[Proposed Rules]
[Pages 18967-18969]
[FR Doc No: 2012-7540]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0339; Directorate Identifier 2011-SW-051-AD]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Eurocopter France (Eurocopter) Model SA.315B Alouette III, SE.3160
Alouette III, SA.316B Alouette III, SA.316C Alouette III, SA.319B
Alouette III, SA 3180-Alouette Astazou, SA 318B-Alouette Astazou, and
SA 318C-Alouette Astazou helicopters. This proposed AD was prompted by
incorrect positioning of the roller drive pocket recesses on the tail
rotor drive shaft free-wheel cage, which caused a pilot to experience a
heavy jerk in the yaw control during in-flight autorotation training.
This condition, if not corrected, could lead to a temporary loss of
tail rotor drive and subsequent loss of control of the helicopter.

DATES: We must receive comments on this proposed AD by May 29, 2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Examining the AD Docket: You may examine the AD docket on the
Internet at http://www.regulations.gov or in person at the Docket
Operations Office between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this proposed AD, the
economic evaluation, any comments received, and other information. The
street address for the Docket Operations Office (telephone 800-647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.
    For service information identified in this proposed AD, contact
American Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie, TX
75052, telephone<PHONE_NUMBER> or<PHONE_NUMBER>, fax<PHONE_NUMBER>,
or at http://www.eurocopter.com/techpub. You may review copies of the
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas 76137.

FOR FURTHER INFORMATION CONTACT: Rao Edupuganti, Aerospace Engineer,
FAA, Rotorcraft Directorate, Regulations and Policy Group, 2601 Meacham
Blvd., Fort Worth, Texas 76137, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued AD No.
2011-0143, dated July 26, 2011 (AD 2011-0143), to correct an unsafe
condition for the Eurocopter model SA.315B Alouette III, SE.3160
Alouette III, SA.316B Alouette III, SA.316C Alouette III, SA.319B
Alouette III, SA 3180-Alouette Astazou, SA 318B-Alouette Astazou, and
SA 318 C-Alouette Astazou helicopters. EASA advises that during in-
flight autorotation

training, a pilot experienced a heavy jerk in the yaw control at the
time of resynchronization. The free-wheel assembly of the helicopter
had been replaced shortly before this flight. Internal inspection of
the free-wheel assembly revealed incorrect positioning of the roller
drive pocket recesses on the free-wheel cage. The subsequent off-
setting restricts the travel of the roller on its ramp and can cause,
under high torque conditions, free-wheel slippage. This condition, if
not corrected, could result in a temporary loss of rotor drive,
jeopardizing flight safety, especially in phases of flight close to the
ground.

FAA's Determination

    We are proposing this AD because we evaluated all known relevant
information and determined that an unsafe condition is likely to exist
or develop on other products of these same type designs.

Related Service Information

    Eurocopter has issued Alert Service Bulletin (ASB) No. Alouette-
65.149, Revision 0, dated March 23, 2011 (ASB 65.149), for model 3130,
313B, 3180, 318B, 318C, 3160, 316B, 316C, and 319B helicopters; and ASB
No. SA315-65.48, Revision 0, dated March 23, 2011 (ASB 65.48), for
model 315B helicopters, which specify removing and disassembling the
free-wheel assembly in order to check the free-wheel cage for correct
positioning. EASA classified these ASBs as mandatory and issued AD
2011-0143 to ensure the continued airworthiness of these helicopters.

Proposed AD Requirements

    This proposed AD would require, within 110 hours time-in-service
(TIS), inspecting the cage of the free-wheel assembly for incorrect
design and, if a free-wheel cage of incorrect design is installed,
before further flight, replacing the affected free-wheel cage with an
airworthy free-wheel cage. This proposed AD would also prohibit
installation of an affected free-wheel cage on any helicopter.

Differences Between This Proposed AD and the EASA AD

    The EASA AD requires compliance within 110 flight hours or 5
months, whichever occurs first. This proposed AD does not impose a
calendar time requirement.

Costs of Compliance

    We estimate that this proposed AD would affect 63 helicopters of
U.S. Registry. We estimate that operators may incur the following costs
in order to comply with this AD.
     Inspecting the free-wheel cage assembly will require 8
work-hours at an average labor rate of $85 per hour, and required parts
will cost $13, for a total cost per helicopter of $693, and a total
cost to the U.S. operator fleet of $43,659.
     Modifying any affected free-wheel cage assembly will
require 8 work hours and required parts will cost $1,986, for a total
cost per helicopter of $2,666.

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.

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, 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 to the extent that
it justifies making a regulatory distinction; 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.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new
Airworthiness Directive (AD):

Eurocopter France: Docket No. FAA-2012-0339; Directorate Identifier
2011-SW-051-AD.

(a) Applicability

    This AD applies to Model SA.315B Alouette III, SE.3160 Alouette
III, SA.316B Alouette III, SA.316C Alouette III, SA.319B Alouette
III, SA 3180-Alouette Astazou, SA 318B-Alouette Astazou, and SA 318
C-Alouette Astazou helicopters with a free-wheel cage, part number
(P/N) 3130S60-10-003 installed, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as incorrect positioning of
the roller drive pocket recesses on the cage of the tail-rotor
driveshaft free-wheel assembly. This condition could result in loss
of tail rotor drive and subsequent loss of control of the
helicopter.

(c) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless accomplished
previously.

(d) Required Actions

    Within 110 hours time-in-service (TIS):
    (1) Remove the free-wheel assembly and pull out the free-wheel
driven head.
    (2) Inspect the free-wheel cage for correct alignment of the
roller drive pocket recesses in accordance with Figure 2 of
Eurocopter Alert Service Bulletin (ASB) No. SA315-65.48, Revision 0
or Eurocopter ASB No. Alouette-65-149, Revision 0, both dated March
23, 2011, as appropriate for your model helicopter.
    (3) If the right edge of the tab is in line with the right edge
of the pocket recess, before further flight, replace the free-wheel
cage with an airworthy free-wheel cage.
    (4) Do not install an affected free-wheel assembly on any
helicopter, unless the cage has passed inspection in accordance with
paragraph (d)(2) through (d)(3) of this AD.

(e) Alternative Methods of Compliance (AMOC)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Rao Edupuganti, Aerospace
Engineer, FAA, Rotorcraft Directorate, Regulations and Policy Group,
2601 Meacham Blvd., Fort Worth, Texas 76137, telephone (817) 222-
5110, email<EMAIL_ADDRESS>    (2) For operations conducted under a Part 119 operating
certificate or under Part 91, Subpart K, we suggest that you notify
your principal inspector, or lacking a principal inspector, the
manager of the local flight standards district office or certificate
holding district office before operating any aircraft complying with
this AD through an AMOC.

(f) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD No. 2011-0143, dated July 26, 2011.

(g) Subject

    Joint Aircraft Service Component (JASC) Code: 6700: Tail Rotor
Drive System.

    Issued in Fort Worth, Texas, on March 20, 2012.
Kim Smith,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2012-7540 Filed 3-28-12; 8:45 am]
BILLING CODE 4910-13-P


                    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                               WASHINGTON, D.C.  20460

	OFFICE OF CHEMICAL SAFETY
	AND POLLUTION PREVENTION

MEMORANDUM

Date:              26 November 2012

SUBJECT:	Halosulfuron-methyl.  Section 3 Registration on Artichoke, and Caneberry Subgroup 13-07A.  Summary of Analytical Chemistry and Residue Data.

PC Code:  128721
      DP Barcode: D405659
Decision No.:  465913
      Registration No.:  81880-18, 81880-2
Petition No.:  2E8050
      Regulatory Action:  Section 3 Registration
Risk Assessment Type:  NA
      Case No.:  NA
TXR No.:  NA
      CAS No.:  100784-20-1
MRID No.:  See MRID Summary Table
      40 CFR:  180.479

FROM:	Leung Cheng, Chemist
		Risk Assessment Branch III (RAB3)
		Health Effects Division (7509P)

THROUGH:	Jeff Dawson, Acting Branch Chief
		RAB3/HED (7509P)

TO:		Barbara Madden/Sydney Jackson (RM Team 03)
		Risk Integration Minor Use, and Emergency Response Branch
		Registration Division (7505P)

MRID Summary Table
MRID No.
Study Type
Comments
48856701
860.1500 Artichoke
New DER 48856701.der
48856702
860.1500 Caneberry
New DER 48856702.der

Executive Summary

Halosulfuron-methyl is a selective herbicide belonging to the sulfonylurea group of herbicides, which inhibits the action of acetolacetate synthase, a specific plant enzyme.  Halosulfuron-methyl is used for the pre- and postemergence control of annual broadleaf weeds and nutsedges in selected crops, as well as residential turf grass and ornamentals, and is formulated as a dry flowable/water-dispersible granule formulation.

The Interregional Research Project No. 4 (IR-4), State Agricultural Experiment Station, Rutgers, The State University of New Jersey, Princeton, New Jersey, on behalf of the IR-4 Project and the Agricultural Experimental Stations of California (for artichoke) and California, Georgia, Oregon, Kentucky, and North Carolina (for caneberry) submitted this petition (PP#2E8050) and requested the submission be reviewed under the Pesticide Registration Improvement Act. IR-4 also requested that the establishment of a tolerance for residues of the herbicide halosulfuron-methyl, methyl 3-chloro-5-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]amino]sulfonyl]-1-methyl-1H-pyrazole-4-carboxylate, in/on the following raw agricultural commodities:

            Artichoke 	0.05 ppm
            Caneberry subgroup 13-07A	0.05 ppm

The petitioner proposed to amend SANDEA herbicide (EPA Reg. No. 81880-18) and GWN-3061 herbicide (EPA Reg. No. 81880-2) to add uses on artichoke and caneberry. Foliar applications are proposed at a maximum application rate of 0.094 lb active ingredient (ai)/A. A 5-day or 14-day preharvest interval is proposed for artichoke and caneberry subgroup 13-07A, respectively.

Permanent tolerances are established under §180.479(a)(1) for residues of halosulfuron-methyl, methyl 3-chloro-5-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]amino]sulfonyl]-1-methyl-1H-pyrazole-4-carboxylate, including its metabolites and degradates, in or on the meat byproducts of cattle, goat, hog, horse, and sheep at 0.1 ppm. Compliance with the tolerance levels specified is to be determined by measuring only those halosulfuron-methyl residues containing the 3-chlorosulfonamide (3-CSA) moiety, expressed as the stoichiometric equivalent of halosulfuron-methyl.

Tolerances are established under §180.479(a)(2) for residues of halosulfuron-methyl, including its metabolites and degradates, in/on a variety of field, fruit, and vegetable crop commodities, at levels ranging from 0.05 to 2.0 ppm. Compliance with the tolerance levels specified is to be determined by measuring only halosulfuron-methyl.

The nature of the residue in plants has been adequately delineated based on acceptable metabolism studies with corn, sugarcane, and soybean treated both pre- and postemergence.  HED has concluded that the residue of concern in plants is halosulfuron-methyl.

The nature of the residue in livestock has been adequately delineated based on metabolism studies with goats and hens.  HED has concluded that the residue of concern in ruminants is halosulfuron-methyl.  HED previously concluded that tolerances for halosulfuron-methyl residues in poultry commodities were not required due to low use rates, low residues of halosulfuron-methyl in poultry feedstuffs, and the low transfer rate of residues to poultry tissues.

Adequate analytical methods (gas chromatography) are available for the enforcement of tolerances for residues of halosulfuron-methyl in plants (Method RES-109-97-4), and for residues of halosulfuron-methyl and its 3-CSA metabolites in livestock commodities (Method RES-046-93).  The plant method determines halosulfuron-methyl as its rearrangement ester (RRE), and the livestock method converts residues of halosulfuron-methyl and metabolites containing the 3-CSA moiety to 3-CSA for determination.  Samples from the submitted artichoke and caneberry studies were analyzed for residues of halosulfuron-methyl using a modified version of the plant enforcement method.  A Biological and Economic Analysis Division (BEAD/EPA) method validation for Method RES-109-97-4 (MRID 44495801) in rice straw, sugar cane, milo grain, field corn grain, cotton gin byproducts, and almond nutmeats indicated a quantitation limit of 0.05 ppm (DP#250584, G. Jeffrey Herndon, 10/28/98).

Residues of halosulfuron-methyl and 3-CSA are not adequately recovered by FDA Multiresidue Method protocols.

Adequate concurrent storage stability data are available for halosulfuron-methyl to support the storage conditions and intervals of artichoke and caneberry samples collected from the field trials.

There are no livestock feedstuffs associated with the proposed use on artichoke and caneberry, and the livestock dietary burden is not altered. Therefore, no changes to the existing livestock commodity tolerances are needed.

Adequate confined and limited field rotational crop data are available. HED previously concluded that rotational crop tolerances and restrictions are not required for halosulfuron-methyl.

There are no Codex or Canadian maximum residue limits (MRLs) established for residues of halosulfuron-methyl in/on artichoke and caneberry.

Regulatory Recommendations and Residue Chemistry Deficiencies

HED has examined the residue chemistry database for halosulfuron-methyl.  Pending submission of a reference standard for the RRE of halosulfuron-methyl (see requirements under Submittal of Analytical Reference Standards), there are no residue chemistry issues that would preclude granting a Section 3 registration for the requested uses on artichoke and caneberry, or the establishment of a tolerance for residues of the halosulfuron-methyl, methyl 3-chloro-5-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-amino]sulfonyl]-1-methyl-1H-pyrazole-4-carboxylate, including its metabolites and degradates, in/on the commodities below. Compliance with the tolerance levels specified is to be determined by measuring only halosulfuron-methyl.

            Artichoke 	0.05 ppm
            Caneberry subgroup 13-07A	0.05 ppm

A human health risk assessment is forthcoming.

Note to RD  -  the tolerance expression under 40 CFR §180.479 (a)(2) should be revised to the following: "residues of the herbicide halosulfuron-methyl, methyl 3-chloro-5-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]amino]sulfonyl]-1-methyl-1H-pyrazole-4-carboxylate, including its metabolites and degradates, in or on the commodities in the following table."

860.1650 Submittal of Analytical Reference Standards

   * An analytical reference standard for the rearrangement ester (RRE) of halosulfuron-methyl must be submitted to the EPA National Pesticide Standards Repository.

Background

The chemical structure and nomenclature of halosulfuron-methyl and the 3-CSA moiety are presented in Table 1.  The physicochemical properties of the technical grade of halosulfuron-methyl are presented in Table 2.

Table 1.	Test Compound Nomenclature.
Chemical structure

Common name
Halosulfuron-methyl
Company experimental name
MON 12000, NC-319
IUPAC name
Methyl 3-chloro-5-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-1-methylpyrazole-4-carboxylate
CAS name
Methyl 3-chloro-5-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]amino]sulfonyl]-1-methyl-1H-pyrazole-4-carboxylate
CAS registry number
100784-20-1
End-use product (EP)
75% dry flowable SANDEA Herbicide; EPA Reg. No. 81880-18) and 75% WG (GWN-3061 Herbicide; EPA Reg. No. 81880-2)
Chemical structure of
3-chlorosulfonamide moiety (3-CSA)

          3-Chloro-1-methyl-5-sulfamoyl-1H-pyrazole-4-carboxylic acid

Table 2.	Physicochemical Properties of Halosulfuron-methyl.
Parameter
Value
Reference
Melting point/range
175.5-177.2 ºC
MRID 42139403; DP#s 173627 & 180565, 7/30/92, G.J. Herndon
pH
4.11 at 25 ºC (1% w/v slurry)

Density
1.618 g/mL at 25 ºC

Water solubility at 20 ºC
pH 5	0.0015 g/100 mL
pH 7	0.165 g/100 mL
pH 9	0.747 g/100 mL

Solvent solubility at 20 ºC
methanol	0.1616 g/100 mL
n-hexane	0.001278 g/100 mL

Vapor pressure
<1 x 10[-7] mm Hg at 25 ºC

Dissociation constant, Ka
3.61 x 10[-4] at 22.4 ºC

Octanol/water partition coefficient, Log(KOW) at 23 ºC
1.67 at pH 5
-0.0186 at pH 7
-0.542 at pH 9

UV/visible absorption spectrum
Not available

860.1200 Directions for Use

Copies of undated labels were provided for a 75% formulation of halosulfuron-methyl (SANDEA herbicide, EPA Reg. No. 81880-18; GWN-3061 herbicide, EPA Reg. No. 81880-2) with uses on artichoke and caneberry. Subsequently, RD transmitted amended Section B (dated November 12, 2012) for caneberry subgroup 13-07A and a revised SANDEA label. The proposed use directions from the SANDEA and GWN-3061 label are summarized in Table 3. According to the SANDEA label, it is a dry flowable formulation; no specification is available on the GWN label. However, the two proposed label use rates on artichoke and caneberry are identical.

Table 3.	Summary of Directions for Use of Halosulfuron-Methyl.
                               Applic. Timing,
                               Type, and Equip.
                                 Applic. Rate
                                   (lb ai/A)
                                   Max. No.
                                  Applic. per
                                    Season
                                 Max. Seasonal
                                 Applic. Rate
                                   (lb ai/A)
                                   PHI (day)
                        Use Directions and Limitations
Caneberry subgroup 13-07A including: blackberry, loganberry, raspberry, black and red, wild raspberry, cultivars, varieties, and/or hybrids of these
Application to either side of crop row, Ground
                        0.5-1 oz (East of the Rockies)
              0.75-2 oz (West of the Rockies) SANDEA or GWN-3061
                                 (0.024-0.094)
                                       2
                                     2 oz
                                    (0.094)
                                      15
Apply a single or sequential application with an interval of 45 days (0.024-0.094 lb ai/A) uniformly with ground equipment in a minimum of 15 gals of water per acre to the ground on either side of the row. Do not apply less than 15 days before harvest. Do not apply if excessive weed growth prevents herbicide contact with ground. Use a non-ionic surfactant with post-emergence applications.
                                   Artichoke
Application to either side of crop row, Ground only
                           1-2 oz SANDEA or GWN-3061
                                 (0.047-0.094)
                                 Not specified
                                     2 oz
                                    (0.094)
                                       5
Apply at 0.047-0.094 lb ai/A uniformly with ground equipment in a minimum of 15 gals of water per acre to the ground on either side of the row and avoiding crop foliage. Do not apply less than 5 days before harvest. Do not apply by air. Use a non-ionic surfactant with post-emergence applications.

Conclusions.  The proposed use directions for the 75% WG formulations are adequate.

860.1300 Nature of the Residue - Plants

Residue Chemistry Memo DP# 251007, 12/10/98, M. Doherty (PP#8F4937)
Residue Chemistry Memo, No DP#, 5/21/96, G.J. Herndon (Metabolism Committee decision)
Residue Chemistry Memo DP# 198361, 7/21/94, G. Otakie (PP#4G4279)
Residue Chemistry Memo DP#s 173627 & 180565, 7/30/92, G.J. Herndon (PP#2G4073)

The nature of the residue in plants is adequately understood based on acceptable metabolism studies with corn, sugarcane, and soybean; all studies investigated pre- and postemergence uses.  The metabolism of halosulfuron-methyl was similar in the three tested crops but dependent on the mode of application (pre- or postemergence).  When halosulfuron-methyl was applied preemergence, initial breakdown of the herbicide in the soil and preferential uptake of the pyrazole moieties resulted in the primary residue being 3-CSA, which has been determined to be less toxic than the parent.  With a postemergence application, the major residue was the parent compound with minimal translocation of the herbicide in the plant, except in grain where the major residue was 3-CSA.

Based on the very low toxicity of the metabolite 3-CSA, relatively low toxicity of the parent compound, and low residue levels of both parent compound and the 3-CSA metabolite, HED previously concluded that the residue of concern in plants is the parent compound, halosulfuron-methyl.

860.1300 Nature of the Residue - Livestock

Residue Chemistry Memo DP# 223801, 11/17/98, M. Doherty (PP#6F4661)
Residue Chemistry Memo, No DP#, 5/21/96, G.J. Herndon (Metabolism Committee decision)
Residue Chemistry Memo DP# 204062, 6/22/94, G.J. Herndon (PP#3F4193)
Residue Chemistry Memo DP# 184435, 1/15/93, G.J. Herndon (PP#2G4073)
Residue Chemistry Memo DP# 181023, 11/12/92, G.J. Herndon
Residue Chemistry Memo DP#s 173627 & 180565, 7/30/92, G.J. Herndon (PP#2G4073)

Acceptable livestock metabolism studies conducted on goats and hens were previously submitted in conjunction with petitions for uses on corn and sorghum.  In goat milk and tissues, the major extractable residue was the parent; acid hydrolysis released bound or conjugated residues of aminopyrimidine and 3-CSA.

As HED previously concluded, the residue of concern in ruminants is halosulfuron-methyl. However, because the approved enforcement method for livestock commodities quantifies the parent compound and metabolites containing the 3-CSA moiety by converting residues to 3-CSA, tolerances for residues of parent and its metabolites in livestock commodities are determined as 3-CSA, expressed in halosulfuron-methyl equivalents.

HED previously concluded (PP#2G4073) that tolerances for halosulfuron-methyl residues in poultry commodities were not required due to low use rates, low residues of halosulfuron-methyl in poultry feed items, and the low transfer rate of residues to poultry tissues.

860.1340 Residue Analytical Methods

Residue Chemistry Memo DP# 250584, 10/28/98, G.J. Herndon (PP#s 6F4620 & 8F4937)
Residue Chemistry Memo DP# 214890, 5/3/95, G.J. Herndon (PP#3F4193)
Residue Chemistry Memo DP# 202131, 10/4/94, G.J. Herndon (PP#3F4193)

Plants

Enforcement method:  An adequate analytical method is available for enforcement of tolerances for halosulfuron-methyl residues in plants.  The gas chromatography (GC) method quantifies halosulfuron-methyl as its RRE (1-H-pyrazole-4-carboxylic acid, 3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl, methyl ester) using thermionic-specific detection (TSD, nitrogen specific).  Monsanto Analytical Method RES-109-97-4 (MRID 44495801) has been validated as an enforcement method by the Analytical Chemistry Branch (ACB)/BEAD.  The limit of quantitation on rice straw, sugarcane, milo grain, field corn grain, cotton gin byproducts, and almond nutmeats was estimated to be 0.05 ppm (DP#250584, G. Jeffrey Herndon, 10/28/98). For confirmation, the RRE can be determined by GC/MS with monitoring at m/z 327.

               Rearrangement ester (RRE) of halosulfuron-methyl

Data collection method:  Samples from the artichoke and caneberry studies associated with the subject petition were analyzed for residues of halosulfuron-methyl using the available tolerance enforcement method, Method RES-109-97-4, with modifications.  Briefly, samples were extracted with acetonitrile (ACN)/water, filtered, and partitioned with dichloromethane (DCM).  The DCM extract was evaporated to dryness and redissolved in 15% methanol/DCM for clean-up through a Florisil solid phase extraction (SPE) cartridge.  The eluate was mixed with 0.5 M potassium carbonate to convert halosulfuron-methyl residues to the RRE.  The reaction mixture was then extracted with DCM, and the DCM extract was evaporated to dryness; residues were reconstituted in ethyl acetate for further clean-up through a silica SPE column.  The eluate was evaporated to dryness and redissolved in 50% ethyl acetate/isooctane for analysis by gas chromatography with nitrogen specific detection (GC/NPD).  Residues were expressed in terms of halosulfuron-methyl.  The GC/NPD method was adequate for data collection based on acceptable method validation and concurrent method recoveries.

Conclusions.  The residue analytical methods data are adequate to satisfy data requirements for the subject action.  Acceptable enforcement methodology is available for tolerance enforcement purposes for residues in/on crop commodities, and residues of halosulfuron-methyl in/on artichoke and caneberry commodities from the crop field trial were determined using an acceptable data collection method.

Livestock

There are no livestock feedstuffs associated with the proposed uses. Therefore, this topic is not relevant.

860.1360 Multiresidue Methods

Residue Chemistry Memo DP# 189198, 3/8/94, G.J. Herndon (PP#3F4193)

Adequate multiresidue method data for halosulfuron-methyl and 3-CSA were submitted previously in conjunction with PP#3F4193.  Residues of halosulfuron-methyl and 3-CSA are not recoverable by the FDA Multiresidue Protocols A through E.  The results have been forwarded to FDA.

860.1380 Storage Stability

Residue Chemistry Memo DP# 189198, 3/8/94, G.J. Herndon (PP#3F4193)

Adequate storage stability data were previously submitted (DP#243050, M. Doherty, 1/5/99)  indicating that halosulfuron-methyl is stable in corn grain stored frozen for up to 823 days (27 months) and in soybeans, wheat, lettuce, and sugar beets stored frozen for up to 996 days (33 months).

Samples from the artichoke and caneberry field trials were stored frozen (~-20 ºC) from harvest/processing to analysis for up to 700 days for artichoke and 627 days for caneberry.  Concurrent storage stability data were provided to support the new studies.

Conclusions.  The concurrent storage stability data are adequate to support the new studies.

860.1400 Water, Fish, and Irrigated Crops

There are no proposed uses that are relevant to this guideline topic.

860.1460 Food Handling

There are no proposed uses that are relevant to this guideline topic.

860.1480 Meat, Milk, Poultry, and Eggs

There are no livestock feed stuffs associated with the proposed uses. Therefore, this topic is not relevant.

860.1500 Crop Field Trials

Artichoke

DER Reference:  48856701.der.doc

The petitioner has submitted field trial data on artichoke.  Three field trials were conducted in the United States during the 2009 growing season in the North American Free Trade Agreement (NAFTA) Growing Zone 10 (CA; 3 trials).

Each trial consisted of one untreated plot and one treated plot.  At each trial location, the treated plots received a single banded application to the ground of a 75% ai formulation (Sandea Herbicide) at 0.093 lb ai/A.  All applications were made using a backpack in spray volumes of 30 gal/A.  An additive (NIS Exit at a concentration of 0.21% v/v) was added to the spray mixture for each of the applications for all trials.

Samples of artichoke head (bud) were harvested at 5 days after application, i.e., at a preharvest interval (PHI) of 5 days.  Samples were analyzed for residues of halosulfuron-methyl using the method "Analytical Method for the Determination of MON 12000 in Raw Agricultural Commodities and Processed Fractions", RES-109-97-4, December 1997.  The method was validated at 0.05 and 0.5 ppm and, therefore, the LOQ (determined as the lowest level of method validation, LLMV) is 0.05 ppm.  The calculated limit of detection is 0.013 ppm.

Samples were placed in frozen storage at the field sites within 45 minutes of collection.  All samples were shipped within 60 days of collection by Agricultural Chemicals Development Services, Inc. (ACDS) freezer truck to the USDA-ARS Research Station, Salinas, CA for frozen storage. Samples were maintained frozen (-20 °C) for about 22 months prior to extraction and analysis at USDA-ARS-SAA, Tifton, GA.

The results of the artichoke field trials are summarized in Table 4.  Following a single foliar broadcast application of the herbicide Sandea at 0.093-0.094 lb ai/A, residues (and per trial averages) of halosulfuron-methyl in/on artichoke heads harvested at 5-day PHIs were all <0.05 ppm.

TABLE 4.  Summary of Residue Data from Crop Field Trials with Halosulfuron-methyl.
Commodity
                                     Total
                                     Rate
                                    lb ai/A
                                  PHI (days)
                            Residue Levels (ppm)[1]

                                       n
                                  Sample Min.
                                  Sample Max.
                                    LAFT[2]
                                    HAFT[2]
                                    Median
                                     Mean
                                  Std.  Dev.
Heads
                                  0.093-0.094
                                       5
                                       3
                                     0.05
                                     0.05
                                     0.05
                                     0.05
                                     0.05
                                     0.05
                                      NA
[1] Except for sample min/max, values reflect per trial averages; n = no.  of field trials.  For calculation of median, mean, and standard deviation, the LOQ (0.05 ppm) was used for any results reported as <LOQ in Table C.3.  N/A = Not applicable.
[2] LAFT = lowest average field trial; HAFT = highest average field trial.

Conclusions.   The number and locations of the field trials are in accordance with OCSPP 860.1500 for artichoke. The submitted field trial data reflect a single postemergence application directed to the ground at 0.093-0.094 lb ai/A, with artichoke heads harvested at PHIs of 5 days. An acceptable method was used for the quantitation of residues of halosulfuron-methyl, and the study is supported by adequate storage stability data.

Caneberry

DER Reference:  48856702.der.doc

The petitioner has submitted field trial data on caneberry.  Four raspberry field trials were conducted in the United States and Canada during the 2008 growing season in the North American Free Trade Agreement (NAFTA) Growing Zones 1 (Williamson, NY), 12 (OR; 2 trials), and 5A (Frelighsburg, QC).  Also, four blackberry field trials were conducted in Zones 2 (Jackson Springs, NC), 5 (Lansing, MI), 10 (Kingsbury, CA), and 12 (Aurora, OR).

Each trial consisted of one untreated plot and one treated plot.  At each trial location, the treated plots received a single banded application to the ground on either side of the caneberry row of a 75% ai formulation (Sandea Herbicide) at 0.094 lb ai/A (range of 0.093-0.098 lb ai/A).  All applications were made using a backpack sprayer in spray volumes of 21-36 gal/A.  An additive (NIS Induce at a concentration of 0.25% v/v) was added to the spray mixture for only the NC trial.

Samples of blackberry and raspberry were harvested at 13-15 days after application, i.e., at a PHI of 13-15 days.  Samples were analyzed for residues of halosulfuron-methyl using the method "Analytical Method for the Determination of MON 12000 in Raw Agricultural Commodities and Processed Fractions", RES-109-97-4, December 1997.  The method was validated at 0.05 and 0.5 ppm and, therefore, the LOQ (determined as the lowest level of method validation, LLMV) is 0.05 ppm.  The calculated limit of detection is 0.016 ppm.

Samples were placed in frozen storage at the field sites within 3 hours of collection.  All samples were shipped within 60 days of collection by Agricultural Chemicals Development Services, Inc. (ACDS) freezer truck to the USDA-ARS Research Station, Salinas, CA for frozen storage. Samples were maintained frozen (-20 °C) for about 21 months prior to extraction and analysis (within 7 days of extraction) at USDA-ARS-SAA, Tifton, GA.

The results of the caneberry field trials are summarized in Table 5. Following a single foliar broadcast application of the herbicide Sandea at 0.093-0.094 lb ai/A, residues (and per trial averages) of halosulfuron-methyl in/on caneberry harvested at 13-15 day PHIs were all <0.05 ppm.

TABLE 5.  Summary of Residue Data from Crop Field Trials with Halosulfuron-methyl.
Commodity
                                     Total
                                     Rate
                                    lb ai/A
                                  PHI (days)
                            Residue Levels (ppm)[1]

                                       n
                                  Sample Min.
                                  Sample Max.
                                    LAFT[2]
                                    HAFT[2]
                                    Median
                                     Mean
                                  Std.  Dev.
Berries
                                  0.093-0.098
                                     13-15
                                       3
                                     0.05
                                     0.05
                                     0.05
                                     0.05
                                     0.05
                                     0.05
                                      NA
[1] Except for sample min/max, values reflect per trial averages; n = no.  of field trials.  For calculation of median, mean, and standard deviation, the LOQ (0.05 ppm) was used for any results reported as <LOQ in Table C.3.  N/A = Not applicable.
[2] LAFT = lowest average field trial; HAFT = highest average field trial.

Conclusions.   The number and locations of the field trials are in accordance with OCSPP 860.1500 for caneberry. The submitted field trial data reflect a single postemergence application directed to the ground at 0.093-0.098 lb ai/A, with caneberry harvested at PHIs of 13-15 days. An acceptable method was used for the quantitation of residues of halosulfuron-methyl, and the study is supported by adequate storage stability data.

860.1520 Processed Food and Feed

There are no processed commodities associated with the proposed uses. Therefore, this topic is not relevant.

860.1650 Submittal of Analytical Reference Standards

An analytical standard is currently available in the EPA National Pesticide Standards Repository for halosulfuron-methyl (expiration 6/14/13).  HED notes that a standard for the rearrangement ester (RRE) of halosulfuron-methyl is also required in support of the tolerance enforcement method for plant commodities.  Analytical reference standards of the 3-CSA metabolite and the RRE 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 Theresa Cole 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 and 860.1900 Confined/Field Accumulation in Rotational Crops

Residue Chemistry Memo DP# 225273, 10/29/98, G.J. Herndon
Residue Chemistry Memo No DP#, 5/21/96, G.J. Herndon (Metabolism Committee decision)
Residue Chemistry Memo DP# 192510, 8/30/93, G. Kramer
Residue Chemistry Memo DP#s 188144 and 188814, 3/11/93, G.J. Herndon ((PP#2G4073)

Acceptable confined rotational and limited field rotational crop studies were previously submitted.  The results of both studies indicate that metabolites containing the pyrazole moiety may accumulate in harvested crops planted at intervals greater than one year.  The confined rotational crop study, conducted at 0.19 lb ai/A, indicated that no measurable residues of halosulfuron-methyl were detected in any rotational crop commodities of wheat, soybean, radish and lettuce at any plantback interval (30, 120, and 360 days after treatment).  The limited field rotational crop study, conducted at 0.22 lb ai/A in a split (preplant + postemergence) application with rotated crops of winter wheat, spring wheat, soybean, sugar beet, and leaf lettuce indicated that no measurable residues of halosulfuron-methyl were detected in any field rotational crop samples, except in one spring wheat forage sample at 0.090 ppm (364-day plantback interval).

HED previously concluded that the residue of concern in rotational crops is halosulfuron-methyl.  Based on the absence of the parent compound in the confined studies and in the limited field rotational crop studies, with the exception of one forage sample, HED previously concluded that rotational crop tolerances and restrictions are not required for halosulfuron-methyl.

860.1550 Proposed Tolerances

The petitioner proposed the following tolerance expression on artichoke and caneberry subgroup 13-07A: residues of halosulfuron-methyl, methyl 3-chloro-5-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]amino]sulfonyl]-1-methyl-1H-pyrazole-4-carboxylate.

RD should revise 40 CFR § 180.479 (a) (2) to include the following tolerance expression: "residues of the herbicide halosulfuron-methyl, methyl 3-chloro-5-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]amino]sulfonyl]-1-methyl-1H-pyrazole-4-carboxylate, including its metabolites and degradates, in or on the commodities in the following table." The compliance statement is correct.

Because all residue values for artichoke and caneberry are below the LOQ, the Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial Data is not utilized for determining an appropriate tolerance level.

There are no Codex or Canadian MRLs established for residues of halosulfuron-methyl in/on artichoke and caneberry.

Table 5. 	Tolerance Summary for Halosulfuron-methyl
Commodity
                           Proposed Tolerance (ppm)
                          Recommended Tolerance (ppm)
Comments; Correct Commodity Definition
Artichoke
                                     0.05
                                     0.05

Caneberry subgroup 13-07A
                                     0.05
                                     0.05

References

DP#s:		173627 & 180565
Subject:	PP#2G4073.  Temporary Tolerance Petition and Experimental Use Permit for Use of MON 12000 (Permit[(R)]) on Corn; 000524-EUP-TO.  Evaluation of Analytical Method and Residue Data.
From:  	G.J. Herndon
To:		J. Miller/D. Kenny and A. Kocialski
Dated:		7/30/92
MRIDs:	42139400-08

DP#s:		181023
Subject:	000524-EUP-TA.  Experimental Use Permit for Use of MON 12000 and MON 13900 Together as MON 12041 (Battalion(R)) on Corn; Evaluation of Analytical Method and Residue Data.  CBTS#:  10295.
From:  	G.J. Herndon
To:		J. Miller/D. Kenny and A. Kocialski
Dated:		11/12/92
MRIDs:	42396202 and 42396203

DP#s:		184435
Subject:	PP#2G4073.  Temporary Tolerance Petition and Experimental Use Permit for Use of MON 12000 (Permit[(R)]) on Corn; 000524-EUP-TO.  Amendment of 7/30/92 Addressing Analytical Method and Residue Data Deficiencies.  CBTS#:  10948.
From:  	G.J. Herndon
To:		J. Miller/D. Kenny and A. Kocialski
Dated:		1/15/93
MRIDs:	42538400-42538404

DP#s:		188144 & 188814
Subject:	PP#2G4073.  Temporary Tolerance Petition and Experimental Use Permit for Use of MON 12000 (Permit(R)) on Corn; 000524-EUP-TO.  Amendment of 2/10/93 Addressing Analytical Method and Proposed Label Deficiencies.  Impact of the Confined Rotational Crop Study Results (EFGWB) on this EUP Request.   CBTS#: 11374 and 11451.
From:  	G.J. Herndon
To:	J. Miller/D. Kenny and A. Kocialski
Dated:		3/11/93
MRIDs:	None

DP#:		192510
Subject:	ID# 000524-UAT.  Review of limited field rotational study of MON 12000 [3-chloro-5-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]amino]-sulfonyl]-1-methyl-1H-pyrazole-4-carboxylic acid, methyl ester].  Case 023936.  CBTS# 12079.
From:  	G. Kramer
To:		J. Miller
Dated:		8/30/93
MRIDs:	42812104

DP#s:		189198, 198051, 189189, 189178, 189183 & 189195
Subject:	PP#3F04193.  Permanent Tolerance Request for Use of MON 12000 (Halosulfuron) on Field Corn and Grain Sorghum (Milo).  Evaluation of Analytical Method and Residue Data.
From:  		G.J. Herndon
To:		J. Miller/D. Kenny and A. Kocialski
Dated:		3/8/94
MRIDs:	42661401-07, 43042601-02

DP#:		204062
Subject:	PP#3F04193.   Section 3 Registration and Permanent Tolerance Request for Use of MON 12000 (Halosulfuron) on Field Corn and Grain Sorghum (Milo).  Submission Received 2/24/93 Addressing Deficiencies in the Nature of the Residue in Plants and Animals.  CBTS# 13817, 13861.
From:  		G.J. Herndon
To:		J. Miller/D. Kenny and A. Kocialski
Dated:		6/22/94
MRIDs:	42678001-03

DP#:		198361
Subject:	PP#4G04279 and 524-EUP-74 - EUP and Temporary Tolerance Request for the New Chemical MON 12000 on Sugarcane and Sorghum.  CBTS No. 13092.
From:  		G. Otakie
To:		J. Miller/D. Kenny and A. Kocialski
Dated:		7/21/94
MRIDs:	42991201-02

DP#:		202131
Subject:	PP#3F04193.  Section 3 Registration and Permanent Tolerance Request for Use of MON 12000 (Halosulfuron) on Field Corn and Grain Sorghum (Milo).  Submission Received 3/29/94 Addressing Deficiencies in the Regulatory Enforcement Method for Animal Products and the Proposed Section F.  CBTS# 13568
From:  		G.J. Herndon
To:		J. Miller/D. Kenny and A. Kocialski
Dated:		10/4/94
MRIDs:	43195001 and 43177501

DP#:		214890
Subject:	PP#3F04193.  Halosulfuron (MON 12000) on Animal Commodities.  Results of the Petition Method Validation Request.  CBTS# 15480.
From:  		G.J. Herndon
To:		J. Miller/D. Kenny and J. Smith
Dated:		5/3/95
MRIDs:	43195001

DP#:		None
Subject:	Halosulfuron (MON 12000).  The HED Metabolism Committee Meeting Held on May 20, 1996.
From:  		G.J. Herndon
To:		HED Metabolism Committee
Dated:		5/21/96
MRIDs:	None

DP#:		250584
Subject:	PP#6F4620 and 8F4937.  Halosulfuron-methyl on Various Commodities.  Results of the Petition Method Validation Request for the Proposed Enforcement Method.
From:  		G.J. Herndon
To:		V. Walters/ J. Tompkins
Dated:		10/28/98
MRIDs:	44495801 and 44555901

DP#:		225273
Subject:	Halosulfuron.  Revised Section F Proposing Deletion of Existing Rotational Crop Tolerances.
From:  		G.J. Herndon
To:		V. Walters/ J. Tompkins
Dated:		10/29/98
MRIDs:	None

DP#:		223801
Subject:	PP6F4661.  Section 3 Registration and Request for Permanent Tolerances for Halosulfuron-methyl on Sweet Corn and Popcorn.  Evaluation of Analytical Methods and Residue Data.
From:  		M. Doherty
To:		J. Tompkins/V. Walters
Dated:		11/17/98
MRIDs:	43918501

DP#:		251007
Subject:	PP8F4937.  Request for Permanent Tolerances for Halosulfuron-methyl on Cotton, Rice, Pistachio Nuts, and Tree Nut Crop Group (Crop Group 14 as listed in 40 CFR 180.41).  Evaluation of Metabolism of Halosulfuron-methyl in Soybean.
From:  		M. Doherty
To:		J. Tompkins/V. Walters
Dated:		12/10/98
MRIDs:	44689501

Attachment:
Appendix 1: International Residue Limit Status sheet

Template Version September 2005

Appendix 1.  International Residue Limits

               Halosulfuron-methyl (PC Code 128721); 10/31/2012
Table A.1 Summary of US and International Tolerances and Maximum Residue Limits
Residue Definition:
US
Canada
Mexico[2]
Codex[3]
40 CFR 180.479 (a) (2):
Tolerances are established for residues of the herbicide halosulfuron-methyl, methyl 3-chloro-5-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]amino]sulfonyl]-1-methyl-1H-pyrazole-4-carboxylate, including its metabolites and degradates, in the table below. Compliance with the tolerance levels specified in the following table is to be determined by measuring only halosulfuron-methyl.
None

None
Commodity[1]
Tolerance (ppm) /Maximum Residue Limit (mg/kg)

                                      US
Canada
Mexico[2]
Codex[3]
Artichoke
                                     0.05

Caneberry subgroup 13-07A
                                     0.05

Completed:  L. Cheng; 11/21/2012
[1] Includes only commodities of interest for this action.  Tolerance values should be the HED recommendations and not those proposed by the applicant.
2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.
3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains.  PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.


[Federal Register Volume 81, Number 195 (Friday, October 7, 2016)]
[Notices]
[Pages 69813-69814]
[FR Doc No: 2016-24377]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL--9953-80-OW]

Information Session; Implementation of the Water Infrastructure
Finance and Innovation Act of 2014

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing plans
to hold information sessions on: October 14, 2016 in Chicago, Illinois;
October 20, 2016 in Orlando, Florida; November 7, 2016 in New York, New
York; November 14, 2016 in San Francisco, California; November 15, 2016
in Los Angeles, California; and November 18, 2016 in Dallas, Texas.
    The purpose of these sessions is to provide potential applicants
with information about the implementation of the ``Water Infrastructure
Finance and Innovation Act of 2014'' (WIFIA).
    Under WIFIA, EPA will provide loans and loan guarantees for water
infrastructure of national or regional significance. It was signed into
law on June 11, 2014 as Public Law 113-121. EPA will provide an
overview of the program's statutory and eligibility requirements,
application and selection process, and creditworthiness assessment. It
will also discuss examples of the potential cost-savings that WIFIA
credit assistance could have for projects. The intended audience is
potential WIFIA applicants including municipal entities, corporations,
partnerships, and State Revolving Fund programs, as well as the private
and

non-governmental organizations that support potential applicants.

DATES: The session in Chicago, Illinois will be held on October 14,
2016 from 9:00 a.m.-3:30 p.m. (CT). The session in Orlando, Florida
will be held on October 20, 2016 from 9:00 a.m.-3:30 p.m. (ET). The
session in New York, New York will be held on November 7, 2016 from
9:00 a.m.-3:30 p.m. (ET). The session in San Francisco, California will
be held on November 14, 2016 from 9:00 a.m.-3:30 p.m. (PT). The session
in Los Angeles, California will be held on November 15, 2016 from 9:00
a.m.-3:30 p.m. (PT). The session in Dallas, Texas will be held on
November 18, 2016 from 9:00 a.m.-3:30 p.m. (CT).

ADDRESSES: The session in Chicago will be held at: Ralph H. Metcalfe
Federal Building, Room 328, 77 West Jackson Boulevard, Chicago,
Illinois 60604. The session in Orlando will be held at: Orange County
Utilities Administration Building, 1st Floor Public Meeting Room, 9150
Curry Ford Road, Orlando, Florida 32825. The session in New York will
be held at: EPA Region 2, 290 Broadway, New York, New York 10007. The
session in San Francisco will be held at: EPA Region 9, 75 Hawthorne
St., San Francisco, California 94105. The session in Los Angeles will
be held at: Los Angeles Federal Building, Room E, 300 North Los Angeles
Street, Los Angeles, California 90012. The session in Dallas will be
held at: EPA Region 6, Fountain Place, 1445 Ross Ave., Dallas, Texas
75202.
    TO REGISTER: Please register at the following link: http://wifia.questionpro.com/.

FOR FURTHER INFORMATION CONTACT: For further information about this
notice, including registration information, contact Karen Fligger, EPA
Headquarters, Office of Water, Office of Wastewater Management at tel.:
202-564-2992; or email<EMAIL_ADDRESS>Members of the public are
invited to participate in the session as capacity allows.

    Authority: Water Infrastructure Finance and Innovation Act,
Public Law 113-121.

    Dated: September 30, 2016.
Andrew D. Sawyers,
Director, Office of Wastewater Management.
[FR Doc. 2016-24377 Filed 10-6-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: August 5, 2008 (Volume 73, Number 151)]
[Notices]
[Page 45465-45466]
[DOCID:fr05au08-70]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0398]

International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex on
Microbiological Examination of Non-Sterile Products: Tests for
Specified Micro-organisms General Chapter; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 4B: Microbiological Examination of Non-Sterile Products: Tests
for Specified Micro-organisms General Chapter.'' The draft guidance was
prepared under the auspices of the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The draft guidance provides the
results of the ICH Q4B evaluation of the Microbiological Examination of
Non-Sterile Products: Tests for Specified Micro-organisms General
Chapter harmonized text from each of the three pharmacopoeias (United
States, European, and Japanese) represented by the Pharmacopoeial
Discussion Group (PDG). The draft guidance conveys recognition of the
three pharmacopoeial methods by the three ICH regulatory regions and
provides specific information regarding the recognition. The draft
guidance is intended to recognize the interchangeability between the
local regional pharmacopoeias, thus avoiding redundant testing in favor
of a common testing strategy in each regulatory region. This draft
guidance is part B of the fourth annex to the core Q4B guidance, which
was made available in the Federal Register of February 21, 2008 (73 FR
9575).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by October 6, 2008.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or
the Office of Communication, Training and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The
guidance may also be obtained by mail by calling CBER at 1-800-835-4709
or<PHONE_NUMBER>. Send two self-addressed adhesive labels to assist the
office in processing your requests. Submit written comments on the
draft guidance to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to http://www.regulations.gov. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Robert H. King, Sr., Center for Drug
Evaluation and Research (HFD-003), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm. 4150, Silver Spring, MD 20993-0002,
301-796-1242; or
     Christopher Joneckis, Center for Biologics Evaluation and Research
(HFM-1), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In June 2008, the ICH Steering Committee agreed that a draft
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex 4B: Microbiological Examination
of Non-Sterile Products: Tests for Specified Micro-organisms General
Chapter'' should be made available for public comment. The draft
guidance is the product of the Q4B Expert Working Group of the ICH.
Comments about this draft will be considered by FDA and the Q4B Expert
Working Group.
    The draft guidance provides the specific evaluation results from
the ICH Q4B process for the Microbiological Examination of Non-Sterile
Products: Tests for Specified Micro-organisms General Chapter
harmonization proposal originating from the three-party PDG. This draft
guidance is in the form of an annex to the core ICH Q4B guidance. Once
finalized, the annex will provide guidance to assist industry and

regulators in the implementation of the specific topic evaluated by the
ICH Q4B process.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/cder/guidance/index.htm,
or http://www.fda.gov/cber/guidelines.htm.

    Dated: July 28, 2008.
Jeffery Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17863 Filed 8-4-08; 8:45 am]

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