[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Proposed Rules]
[Page 10256]
[FR Doc No: 2023-03419]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2022-0115; FRL-9755-03-R10]

Air Plan Partial Approval and Partial Disapproval; AK, Fairbanks
North Star Borough; 2006 24-Hour PM2.5 Serious Area and 189(d) Plan;
Extension of Comment Period and Public Hearing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of comment period; and notification of
public hearing.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing a
public hearing to be held for the proposed action titled, ``Air Plan
Partial Approval and Partial Disapproval; AK, Fairbanks North Star
Borough; 2006 24-hour PM2.5 Serious Area and 189(d) Plan''
which was published in the Federal Register on January 10, 2023. The
EPA is also announcing the extension of the comment period for the
proposed rulemaking to allow for sufficient time after the public
hearing for commenters to submit comments.

DATES:
    Written comments: The comment period for the proposed rulemaking
published January 10, 2023 (88 FR 1454), is extended. The EPA must
receive comments on the proposed action on or before March 22, 2023.
    Public hearing. A public hearing will be held on March 7, 2023, to
provide interested parties the opportunity to present information and
opinions to the EPA concerning the proposed action. For further
information on the public hearing, please see the SUPPLEMENTARY
INFORMATION section.

ADDRESSES:
    Public hearing. The public hearing will be held at the Wood Center,
University of Alaska Fairbanks, 1731 S Chandalar Drive, Fairbanks, AK
99775. Additional information on the public hearing is provided in the
SUPPLEMENTARY INFORMATION section of this document.
    Written Comments. Submit your written comments, identified by
Docket ID No. EPA-R10-OAR-2022-0115, at https://www.regulations.gov.
Please refer to the EPA's proposed action published in the Federal
Register on January 10, 2023 (88 FR 1454), for instructions for
submitting written comments.

FOR FURTHER INFORMATION CONTACT: Matthew Jentgen, EPA Region 10, 1200
Sixth Avenue--Suite 155, Seattle, WA 98101,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: The EPA is holding a hearing on its proposed
action on the Fairbanks North Star Borough 2006 24-hour
PM2.5 Serious Area and 189(d) Plans. The EPA's proposed
action was published in the Federal Register on January 10, 2023, (88
FR 1454).
    The public hearing will be held on March 7, 2023, and will begin at
2 p.m. Alaska Standard Time (AKST). There will be a half hour break for
dinner beginning at 5 p.m. The public hearing will re-start at 5:30
p.m. and will conclude at 8 p.m. AKST.
    The hearing will be limited to the subject matter of the proposed
action published in the Federal Register on January 10, 2023 (88 FR
1454). A 3-minute time limit may be placed on all oral testimony. The
EPA may ask clarifying questions during oral testimony but will not
respond to comments at that time. The EPA will not be providing
equipment for commenters to show overhead slides or make computerized
slide presentations. All oral testimony will be transcribed verbatim.
The EPA will publish the verbatim transcript to the public docket for
this action.
    If you require the services of a translator or special
accommodations such as audio description, please pre-register for the
hearing by contacting the person in the FOR FURTHER INFORMATION CONTACT
section of this document and describe your needs by March 1, 2023. The
EPA may not be able to arrange accommodations without advance notice.
    Written comments may also be submitted at the public hearing.
Written statements and supporting information submitted during the
comment period will be considered with the same weight as any oral
comments and supporting information presented at the public hearing.
The EPA recommends submitting the text of your oral comments as written
comments to the rulemaking Docket ID No. EPA-R10-OAR-2022-0115, which
can be found at https://www.regulations.gov.
    In the final rule, the EPA will provide a written response to all
relevant written and oral comments received during the comment period
on the proposed rule. A transcript of the hearing and written comments
will be made available upon request from the person listed in the FOR
FURTHER INFORMATION CONTACT section in this document, and will be
included in the public docket for this action.

    Dated: February 13, 2023.
Krishnaswamy Viswanathan,
Director, Air and Radiation Division, Region 10.
[FR Doc. 2023-03419 Filed 2-16-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Pages 55090-55092]
[FR Doc No: 2021-21622]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93191; File No. SR-NYSEArca-2021-57]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Instituting
Proceedings To Determine Whether To Approve or Disapprove a Proposed
Rule Change To List and Trade Shares of the NYDIG Bitcoin ETF Under
NYSE Arca Rule 8.201-E

September 29, 2021.
    On June 30, 2021, NYSE Arca, Inc. (``NYSE Arca'' or ``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
list and trade shares (``Shares'') of the NYDIG Bitcoin ETF (``Trust'')
under NYSE Arca Rule 8.201-E (Commodity-Based Trust Shares). The
proposed rule change was published for comment in the Federal Register
on July 19, 2021.\3\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 92395 (July 13,
2021), 86 FR 38129 (July 19, 2021) (``Notice''). Comments on the
proposed rule change can be found at: https://www.sec.gov/comments/sr-nysearca-2021-57/srnysearca202157.htm.
---------------------------------------------------------------------------

    On August 23, 2021, pursuant to Section 19(b)(2) of the Act,\4\ the
Commission designated a longer period within which to approve the
proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to disapprove the proposed rule
change.\5\ This order institutes proceedings under Section 19(b)(2)(B)
of the Act \6\ to determine whether to approve or disapprove the
proposed rule change.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 92722 (Aug. 23,
2021), 86 FR 48268 (Aug. 27, 2021). The Commission designated
October 17, 2021, as the date by which it should approve,
disapprove, or institute proceedings to determine whether to
disapprove the proposed rule change.
    \6\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

I. Summary of the Proposal

    As described in more detail in the Notice,\7\ the Exchange proposes
to list and trade the Shares of the Trust under NYSE Arca Rule 8.201-E,
which governs the listing and trading of Commodity-Based Trust Shares
on the Exchange.
---------------------------------------------------------------------------

    \7\ See Notice, supra note 3.
---------------------------------------------------------------------------

    The investment objective of the Trust is to reflect the performance
of the price of bitcoin less the expenses of the Trust's operations.\8\
The Trust will not seek to reflect the performance of any benchmark or
index. In seeking to achieve its investment objective, the Trust will
only hold bitcoin.\9\ The Trust generally does not intend to hold cash
or cash equivalents. However, the Trust may hold cash and cash
equivalents on a temporary basis to pay extraordinary expenses.\10\
---------------------------------------------------------------------------

    \8\ See id. at 38129. NYDIG Asset Management LLC (``Sponsor'')
is the sponsor of the Trust, and Delaware Trust Company is the
trustee. U.S. Bancorp Fund Services, LLC (``Administrator'') is the
transfer agent and the administrator of the Trust. The bitcoin
custodian for the Trust is NYDIG Trust Company LLC (``Bitcoin
Custodian''). The Bitcoin Custodian is chartered as a limited
purpose trust company by the New York State Department of Financial
Services (``NYDFS'') and is authorized by NYDFS to provide digital
asset custody services. Both the Sponsor and the Bitcoin Custodian
are indirect wholly-owned subsidiaries of New York Digital
Investment Group LLC. See id.
    \9\ See id.
    \10\ See id. at 38130. The Trust will enter into a cash custody
agreement with U.S. Bank N.A. under which U.S. Bank N.A. will act as
custodian of the Trust's cash and cash equivalents. See id.
---------------------------------------------------------------------------

    The net asset value (``NAV'') of the Trust will be determined in
accordance with Generally Accepted Accounting Principles (``GAAP'') as
the total value of bitcoin held by the Trust, plus any cash or other
assets, less any liabilities including accrued but unpaid expenses. The
NAV of the Trust will typically be determined as of 4:00 p.m. E.T. on
each day that the Exchange is open for regular trading (``Business
Day''). The Administrator will calculate the NAV of the Trust once each
Exchange trading day. The Exchange's Core Trading Session closes at
4:00 p.m. E.T. The Trust's daily activities will generally not be
reflected in the NAV determined for the Business Day on which the
transactions are effected (the trade date), but rather on the following
Business Day. The NAV for the Trust's Shares will be disseminated daily
to all market participants at the same time.\11\
---------------------------------------------------------------------------

    \11\ See id. at 38130-32.
---------------------------------------------------------------------------

    The Trust will disseminate an intraday indicative value (``IIV'')
per Share updated every 15 seconds. The IIV will be calculated by using
the same methodology that the Trust uses to determine NAV, which is to
follow GAAP. Generally, GAAP requires the fair value of an asset that
is traded on a market to be measured by reference to orderly
transactions on an active

market. Among all active markets with orderly transactions, the market
that is used to determine the fair value of an asset is the principal
market. The Sponsor expects that the principal market will initially
generally be the NYDFS-regulated trading venue with the highest trading
volume and level of activity.\12\
---------------------------------------------------------------------------

    \12\ See id. at 38132.
---------------------------------------------------------------------------

    The Trust will create and redeem Shares from time to time, but only
in one or more blocks of 10,000 Shares (``Creation Baskets''). Creation
Baskets will only be made in exchange for delivery to the Trust or the
distribution by the Trust of the amount of bitcoin represented by the
Shares being created or redeemed, the amount of which will be based on
the quantity of bitcoin attributable to each Share of the Trust (net of
accrued but unpaid Sponsor fees, extraordinary expenses or liabilities)
being created or redeemed determined as of 4:00 p.m. E.T. on the day
the order is properly received.\13\
---------------------------------------------------------------------------

    \13\ See id.
---------------------------------------------------------------------------

II. Proceedings To Determine Whether To Approve or Disapprove SR-
NYSEArca-2021-57 and Grounds for Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to Section
19(b)(2)(B) of the Act \14\ to determine whether the proposed rule
change should be approved or disapproved. Institution of proceedings is
appropriate at this time in view of the legal and policy issues raised
by the proposed rule change, as discussed below. Institution of
proceedings does not indicate that the Commission has reached any
conclusions with respect to any of the issues involved. Rather, as
described below, the Commission seeks and encourages interested persons
to provide comments on the proposed rule change.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

    Pursuant to Section 19(b)(2)(B) of the Act,\15\ the Commission is
providing notice of the grounds for disapproval under consideration.
The Commission is instituting proceedings to allow for additional
analysis of the proposed rule change's consistency with Section 6(b)(5)
of the Act, which requires, among other things, that the rules of a
national securities exchange be ``designed to prevent fraudulent and
manipulative acts and practices'' and ``to protect investors and the
public interest.'' \16\
---------------------------------------------------------------------------

    \15\ Id.
    \16\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission asks that commenters address the sufficiency of the
Exchange's statements in support of the proposal, which are set forth
in the Notice,\17\ in addition to any other comments they may wish to
submit about the proposed rule change. In particular, the Commission
seeks comment on the following questions and asks commenters to submit
data where appropriate to support their views:
---------------------------------------------------------------------------

    \17\ See Notice, supra note 3.
---------------------------------------------------------------------------

    1. What are commenters' views on whether the proposed Trust and
Shares would be susceptible to manipulation? What are commenters' views
generally on whether the Exchange's proposal is designed to prevent
fraudulent and manipulative acts and practices? What are commenters'
views generally with respect to the liquidity and transparency of the
bitcoin markets, the bitcoin markets' susceptibility to manipulation,
and thus the suitability of bitcoin as an underlying asset for an
exchange-traded product?
    2. The Exchange asserts that the ``significant increase in trading
volume and open interest in the bitcoin futures market, growth of
liquidity in the spot market for bitcoin, and certain features of the
Shares mitigate the manipulation concerns expressed by the Commission
when it last reviewed exchange proposals to list a bitcoin exchange-
traded product.'' \18\ The Exchange concludes ``that, on the whole, the
manipulation concerns previously articulated by the Commission have
since been significantly mitigated, and do not exceed those that exist
in the markets for other commodities that underly [sic] securities
listed on U.S. national securities exchanges.'' \19\ Do commenters
agree or disagree? Are the changes that the Exchange identifies
sufficient to support the determination that the proposal to list and
trade the Shares is designed to protect investors and the public
interest and is consistent with the other applicable requirements of
Section 6(b)(5) of the Act?
---------------------------------------------------------------------------

    \18\ See id. at 38134.
    \19\ See id.
---------------------------------------------------------------------------

    3. The Exchange states that the ``Trust would provide investors
with exposure to bitcoin in a manner that may be more efficient, more
convenient and more regulated than the purchase of bitcoin or other
investment products that provide exposure to bitcoin.'' \20\ The
Exchange asserts that ``investors in [over-the-counter] bitcoin funds .
. . have historically borne significantly higher fees and expenses than
those that would be borne by investors in the Trust'' and that
investors holding bitcoin often face ``credit risk'' and ``risk of loss
or theft of their bitcoin.'' \21\ What are commenters' views regarding
the Exchange's assertions? Do these reasons provide an appropriate
basis for the determination that the proposal is consistent with the
applicable requirements of Section 6(b)(5) of the Act?
---------------------------------------------------------------------------

    \20\ See id.
    \21\ See id.
---------------------------------------------------------------------------

    4. The Exchange asserts that the Chicago Mercantile Exchange
(``CME'') represents a regulated market of significant size relating to
bitcoin.\22\ The Exchange states that ``proprietary research, including
lead-lag analyses, . . . demonstrates that prices in the CME bitcoin
futures market . . . lead prices in the bitcoin spot market, including
non-U.S. bitcoin spot markets.'' According to the Exchange, ``[t]his
finding supports the thesis that a market participant attempting to
manipulate the Shares would have to trade on that market.'' \23\ The
Exchange, however, does not provide any information regarding the
proprietary research. What are commenters' views regarding these
assertions?
---------------------------------------------------------------------------

    \22\ See id.
    \23\ See id. at 38135.
---------------------------------------------------------------------------

    5. According to the Exchange, ``the bitcoin futures market is one
of the primary venues that market participants use to transact large
exposures to bitcoin,'' and, ``[i]n contrast to the efficient leverage
offered through the futures market, many bitcoin spot trading venues
require full pre-funding of trading, which means it would be highly
capital intensive to `spoof' or `layer' order books on spot trading
venues.'' \24\ The Exchange therefore concludes that if a market
participant intended to manipulate the price of bitcoin, and thereby
the Shares, the bitcoin futures market is the one that would be
manipulated first.\25\ Do commenters agree with the Exchange's analysis
and conclusion?
---------------------------------------------------------------------------

    \24\ See id.
    \25\ See id.
---------------------------------------------------------------------------

    6. What are commenters' views of the Exchange's assertion that (a)
the significant volume in the bitcoin futures market; (b) the overall
size of the bitcoin market; (c) the significant liquidity available in
the bitcoin spot markets; and (d) the ability of market participants to
buy or sell large amounts of bitcoin without significant market impact
demonstrate that the Shares would not become the predominant force on
pricing in either the bitcoin spot or futures markets? \26\
---------------------------------------------------------------------------

    \26\ See id. at 38136.
---------------------------------------------------------------------------

    7. What are commenters' views on the Exchange's statements that
``the cost to buy or sell $5 million worth of bitcoin

averages roughly 20 basis points'' and that, ``[f]or a $10 million
market order, the cost to buy or sell is roughly 40 basis points.''
\27\ What are commenters' views of the Exchange's assertion that these
metrics are comparable to the liquidity of existing commodity exchange-
traded products? \28\ What are commenters' views on the Exchange's
assertion that the fact that ``the Trust receives and holds only
bitcoin . . . substantially reduces the potential for manipulation of
the number of Shares created or redeemed, which therefore substantially
reduces the potential for shareholders to be harmed by manipulation.''?
\29\
---------------------------------------------------------------------------

    \27\ See id.
    \28\ See id.
    \29\ See id. at 38135.
---------------------------------------------------------------------------

III. Procedure: Request for Written Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
issues identified above, as well as any other concerns they may have
with the proposal. In particular, the Commission invites the written
views of interested persons concerning whether the proposal is
consistent with Section 6(b)(5) or any other provision of the Act, and
the rules and regulations thereunder. Although there do not appear to
be any issues relevant to approval or disapproval that would be
facilitated by an oral presentation of views, data, and arguments, the
Commission will consider, pursuant to Rule 19b-4, any request for an
opportunity to make an oral presentation.\30\
---------------------------------------------------------------------------

    \30\ Section 19(b)(2) of the Act, as amended by the Securities
Act Amendments of 1975, Public Law 94-29 (June 4, 1975), grants the
Commission flexibility to determine what type of proceeding--either
oral or notice and opportunity for written comments--is appropriate
for consideration of a particular proposal by a self-regulatory
organization. See Securities Act Amendments of 1975, Senate Comm. on
Banking, Housing & Urban Affairs, S. Rep. No. 75, 94th Cong., 1st
Sess. 30 (1975).
---------------------------------------------------------------------------

    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposal should be approved or
disapproved by October 26, 2021. Any person who wishes to file a
rebuttal to any other person's submission must file that rebuttal by
November 9, 2021.
    Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2021-57 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2021-57. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEArca-2021-57 and should be submitted
by October 26, 2021. Rebuttal comments should be submitted by November
9, 2021.
---------------------------------------------------------------------------

    \31\ 17 CFR 200.30-3(a)(57).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\31\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-21622 Filed 10-4-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 9, 2006 (Volume 71, Number 217)]
[Notices]
[Page 65791-65792]
[DOCID:fr09no06-61]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-53-000]

Enbridge Pipelines (Midla) L.L.C.; Notice of Proposed Changes in
FERC Gas Tariff

November 3, 2006.
    Take notice that on November 1, 2006, Enbridge Pipelines (Midla)
L.L.C. (Midla) tendered for filing as part of its FERC Gas Tariff,
Fifth Revised Volume No. 1, the following tariff sheets, to become
effective on December 1, 2006:

First Revised Sheet No. 22,
First Revised Sheet No. 23,
First Revised Sheet No. 30,
First Revised Sheet No. 41,
Third Revised Sheet No. 102,
First Revised Sheet No. 183A,
First Revised Sheet No. 300,
Original Sheet No. 300A,
First Revised Sheet No. 301,
Original Sheet No. 301A,
First Revised Sheet No. 307,
First Revised Sheet No. 308,
First Revised Sheet No. 311,
Original Sheet No. 311A,
First Revised Sheet No. 317,
First Revised Sheet No. 318,
First Revised Sheet No. 331,
Original Sheet No. 331A,
First Revised Sheet No. 337,
First Revised Sheet No. 338.

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission,

888 First Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

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

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-19004 Filed 11-8-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 36 (Thursday, February 23, 2012)]
[Notices]
[Page 10740]
[FR Doc No: 2012-4191]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 14269-000; 14270-000]

Riverbank Hydro No. 22, LLC; FFP Project 93, LLC; Notice
Announcing Preliminary Permit Drawing

    The Commission has received two preliminary permit applications
deemed filed on September 1, 2011, at 8:30 a.m.,\1\ for proposed
projects to be located at the U.S. Army Corps of Engineers' Green River
Lock and Dam No. 5, on the Green River in Butler and Warren Counties,
Kentucky. The applications were filed by Riverbank Hydro No. 22, LLC
for Project No. 14269-000, and FFP Project 93, LLC for Project No.
14270-000.
---------------------------------------------------------------------------

    \1\ Under the Commission's Rules of Practice and Procedure, any
document received after regular business hours is considered filed
at 8:30 a.m. on the next regular business day. 18 CFR 385.2001(a)(2)
(2011).
---------------------------------------------------------------------------

    On February 28, 2012, at 9 a.m. (eastern time), the Secretary of
the Commission, or her designee, will conduct a random drawing to
determine the filing priority of the applicants identified in this
notice. The Commission will select among competing permit applications
as provided in section 4.37 of its regulations.\2\ The priority
established by this drawing will be used to determine which applicant,
among those with identical filing times, will be considered to have the
first-filed application.
---------------------------------------------------------------------------

    \2\ 18 CFR 4.37 (2011).
---------------------------------------------------------------------------

    The drawing is open to the public and will be held in room 2C, the
Commission Meeting Room, located at 888 First St. NE., Washington, DC
20426. A subsequent notice will be issued by the Secretary announcing
the results of the drawing.

    Dated: February 16, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-4191 Filed 2-22-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 168 (Friday, August 28, 2020)]
[Notices]
[Page 53427]
[FR Doc No: 2020-19156]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: 2:00 p.m. on Wednesday, September 2, 2020.

PLACE: The meeting will be held via remote means and/or at the
Commission's headquarters, 100 F Street NE, Washington, DC 20549.

STATUS: This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    In the event that the time, date, or location of this meeting
changes, an announcement of the change, along with the new time, date,
and/or place of the meeting will be posted on the Commission's website
at https://www.sec.gov.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    The subject matter of the closed meeting will consist of the
following topic:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Resolution of litigation claims; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting agenda items that may consist of
adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFORMATION: For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: August 26, 2020.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-19156 Filed 8-26-20; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Rules and Regulations]
[Pages 33744-33748]
[FR Doc No: 2013-13267]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0704; FRL-9386-9]

Sedaxane; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
sedaxane in or on multiple commodities which are identified and
discussed later in this document. Syngenta Crop Protection, LLC
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective June 5, 2013. Objections and
requests for hearings must be received on or before August 5, 2013, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0704, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Heather Garvie, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0704 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
August 5, 2013. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0704, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 28, 2012 (77 FR 59578) (FRL-
9364-6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2F8071) by Syngenta Crop Protection, Inc., Regulatory Affairs, P.O. Box
18300, Greensboro, NC 27419-8300. The petition requested that 40 CFR
180.665 be amended by establishing tolerances for residues of the
fungicide sedaxane, in or on corn (grain, forage, stover), popcorn
(grain, stover), and corn ears at 0.01 parts per million (ppm); sorghum
(grain, forage, stover) at 0.01 ppm; pea and bean, dried, shelled,
subgroup 6C (grain, forage, hay) at 0.01 ppm; and rapeseed, subgroup
20A (grain) at 0.01 ppm. That document referenced a

summary of the petition prepared by Syngenta Crop Protection, Inc., the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
corrected commodity definitions and recommended additional tolerances.
The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for sedaxane including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with sedaxane follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The toxicological effects reported in the submitted animal
studies such as mitochondrial disintegration and glycogen depletion in
the liver are consistent with the pesticidal mode of action also being
the mode of toxic action in mammals. The rat is the most sensitive
species tested, and the main target tissue for sedaxane is the liver.
Sedaxane also caused thyroid hypertrophy/hyperplasia. In the acute
neurotoxicity (ACN) and sub-chronic neurotoxicity (SCN) studies,
sedaxane caused decreased activity, decreased muscle tone, decreased
rearing and decreased grip strength.
    There are indications of reproductive toxicity in rats at the high
dose, but these effects did not result in reduced fertility. In the
rat, no adverse effects in fetuses were seen in developmental toxicity
studies at maternally toxic doses. However, in the rabbit, fetal
toxicity was observed at the same doses as the dams. Offspring effects
in the reproduction study occurred at the same doses causing parental
effects, thus there was no quantitative increase in sensitivity in rat
pups. Sedaxane is tumorigenic in the liver in the rat and mouse, and
led to tumors in the thyroid and uterus in the rat and was classified
as ``likely to be carcinogenic to humans.'' Sedaxane was negative in
the mutagenicity studies. The 28-day dermal study did not show systemic
toxicity at the limit dose of 1,000 milligrams/kilogram/day (mg/kg/
day). Sedaxane has low acute toxicity by the oral, dermal, and
inhalation routes. It is not a dermal sensitizer, causes no skin
irritation and only slight eye irritation.
    Specific information on the studies received and the nature of the
adverse effects caused by sedaxane as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of June 20, 2012 (77 FR 36919) (FRL-
9345-8).

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for sedaxane used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of June 20, 2012.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to sedaxane, EPA considered exposure under the petitioned-for
tolerances as well as all existing sedaxane tolerances in 40 CFR
180.665. EPA assessed dietary exposures from sedaxane in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for sedaxane. In estimating acute dietary exposure, EPA used food
consumption information from the U.S. Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA conducted a
highly conservative acute dietary risk assessment which used tolerance
level residues and assumed 100 percent crop treated (PCT) for all
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA conducted a highly
conservative chronic dietary risk assessment which used tolerance level
residues and assumed 100 PCT for all commodities.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
If a quantitative cancer risk assessment is appropriate, cancer risk
may be quantified using a linear or nonlinear approach. If sufficient

information on the carcinogenic mode of action is available, a
threshold or nonlinear approach is used and a cancer RfD is calculated
based on an earlier non-cancer key event. If carcinogenic mode of
action data are not available, or if the mode of action data determines
a mutagenic mode of action, a default linear cancer slope factor
approach is utilized. Based on significant tumor increases in two
adequate rodent carcinogenicity studies and as noted in Unit III.A.,
EPA has concluded that sedaxane should be classified as ``Likely To Be
Carcinogenic to Humans.'' EPA used a linear approach to quantify cancer
risk because mode of action data are not available for sedaxane. EPA
assessed exposure for the purpose of estimating cancer risk assuming
tolerance-level residues and 100 PCT for all commodities and included
modeled drinking water estimates.
    iv. Anticipated residue PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for sedaxane. One-hundred PCT was assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for sedaxane in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of sedaxane. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the FQPA First Index Reservoir Screening Tool (FIRST) and
Tier II Pesticide Root Zone Model/Groundwater (PRZM-GW Version 1.0, 12/
11/2012), the estimated drinking water concentrations (EDWCs) of
sedaxane for acute exposures are estimated to be 4.1 parts per billion
(ppb) for surface water and 9.9 ppb for ground water. The water
exposures for the chronic dietary and cancer assessments are estimated
to be 1.2 ppb for surface water and 8.4 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 9.9 ppb was used to assess
the contribution to drinking water. For chronic and cancer dietary risk
assessment, the water concentration value of 8.4 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Sedaxane is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not found sedaxane
to share a common mechanism of toxicity with any other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
sedaxane does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence for
increased susceptibility following prenatal and/or postnatal exposures
to sedaxane based on effects seen in developmental toxicity studies in
rabbits or rats. There was no evidence of increased susceptibility in a
2-generation reproduction study in rats following prenatal or postnatal
exposure to sedaxane. Clear NOAELs/LOAELs were established for the
developmental effects seen in rats and rabbits as well as for the
offspring effects seen in the 2-generation reproduction study. The
dose-response relationship for the effects of concern is well
characterized. The NOAEL used for the acute dietary risk assessment (30
mg/kg/day), based on effects observed in the ACN study, is protective
of the developmental and offspring effects seen in rabbits and rats
(NOAELs of 100-200 mg/kg/day).
    In addition, there is no evidence of neuropathology or
abnormalities in the development of the fetal nervous system from the
available toxicity studies conducted with sedaxane.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database for sedaxane is complete.
    ii. The sedaxane toxicology database did not demonstrate evidence
of neurotoxicity. Although sedaxane caused changes in endpoints such as
decreased activity, decreased muscle tone, decreased rearing and
decreased grip strength in the ACN study and reduced locomotor activity
in the SCN study, EPA believes these effects do not support a finding
that sedaxane is a neurotoxicant. The observed effects in the ACN and
SCN studies were likely secondary to inhibition of mitochondrial energy
production, which is the pesticidal mode of action for sedaxane.
Furthermore, there was no corroborative neuro-histopathology
demonstrated in any study, even at the highest doses tested (i.e.,
2,000 mg/kg/day). Therefore, based on its chemical structure, its
pesticidal mode of action, and lack of evidence of neuro-histopathology
in any acute and repeated-dose toxicity study, sedaxane does not
demonstrate potential for neurotoxicity. Since sedaxane did not
demonstrate increased susceptibility to the young or specific
neurotoxicity, a developmental neurotoxicity (DNT) study is not
required.
    iii. There is no evidence that sedaxane results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to sedaxane in drinking water. These assessments
will not underestimate the exposure and risks posed by sedaxane.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    Sedaxane is a member of the pyrazole carboxamide fungicides.
Metabolic processes involving cleavage of the linkage between the
pyrazole and phenyl rings of these compounds have the potential to
produce common pyrazole-metabolites. Indeed, confined rotational crops
studies for sedaxane and isopyrazam demonstrate that low levels of
three common metabolites form. However, due to the low levels of these
compounds in rotational crops (<=0.01 ppm), and low concerns about
their potential toxicity relative to parent molecules, any risks from
aggregation of exposures to common metabolites across chemicals will be
insignificant.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to sedaxane will occupy <1% of the aPAD for all populations.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
sedaxane from food and water will utilize <1% of the cPAD for all
populations. There are no residential uses for sedaxane.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Short- and
intermediate-term adverse effects were identified; however, sedaxane is
not registered for any use patterns that would result in short- or
intermediate-term residential exposures. Because there is no short- or
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess short-term risk), no
further assessment of short- or intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
short- and intermediate-term risk for sedaxane.
    4. Aggregate cancer risk for U.S. population. The Agency has
classified sedaxane as ``Likely to be Carcinogenic to Humans'' based on
significant tumor increases in two adequate rodent carcinogenicity
studies. Accordingly, a cancer dietary risk assessment was conducted,
indicating a risk estimate of 1 x 10-6 for the U.S.
population.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to sedaxane residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the
tolerance expression. A modification of the Quick, Easy, Cheap,
Effective, Rugged, and Safe (QuEChERS) method was developed for the
determination of residues of sedaxane (as its isomers SYN508210 and
SYN508211) in/on various crops. A successful independent laboratory
validation (ILV) study was also conducted on the modified QuEChERS
method using samples of wheat green forage and wheat straw fortified
with SYN508210 and SYN508211 at 0.005 and 0.05 ppm. The analytical
standard for sedaxane, with an expiration date of June 30, 2014, is
currently available in the EPA National Pesticide Standards Repository.
The method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established MRLs for sedaxane.

C. Revisions to Petitioned-For Tolerances

    The Agency determined that the application of sedaxane to sweet
corn (resulting in residues on corn, sweet, kernel plus cob with husks
removed) would result in residues to the livestock feedstuffs corn,
sweet, forage and corn, sweet, stover; therefore, EPA is establishing
tolerances of 0.01 ppm for those commodities. EPA is also correcting
commodity definitions for the tolerances.

V. Conclusion

    Therefore, tolerances are established for residues of sedaxane,
including its metabolites and degradates in or on corn, field, forage;
corn, field, grain; corn, field, stover; corn, pop, grain; corn, pop,
stover; corn, sweet, forage; corn, sweet, kernel plus cob with husks
removed; corn, sweet, stover; pea and bean, dried shelled, except
soybean, subgroup 6C; rapeseed, subgroup 20A; sorghum, grain, forage;
sorghum, grain, grain; sorghum, grain, stover; and vegetable, foliage
of legume, except soybean, subgroup 7A, all at a tolerance level of
0.01 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children From Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions To Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994). Since
tolerances and exemptions

that are established on the basis of a petition under FFDCA section
408(d), such as the tolerance in this final rule, do not require the
issuance of a proposed rule, the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: May 29, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.665, add alphabetically the following commodities to
the table in paragraph (a) to read as follows:

Sec.  180.665  Sedaxane; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Corn, field, forage........................................         0.01
Corn, field, grain.........................................         0.01
Corn, field, stover........................................         0.01
Corn, pop, grain...........................................         0.01
Corn, pop, stover..........................................         0.01
Corn, sweet, forage........................................         0.01
Corn, sweet, kernel plus cob with husks removed............         0.01
Corn, sweet, stover........................................         0.01

                                * * * * *
Pea and bean, dried shelled, except soybean, subgroup 6C...         0.01
Rapeseed, subgroup 20A.....................................         0.01

                                * * * * *
Sorghum, grain, forage.....................................         0.01
Sorghum, grain, grain......................................         0.01
Sorghum, grain, stover.....................................         0.01

                                * * * * *
Vegetable, foliage of legume, except soybean, subgroup 7A..         0.01

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-13267 Filed 6-4-13; 8:45 am]
BILLING CODE 6560-50-P