[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Proposed Rules]
[Pages 30228-30230]
[FR Doc No: 2021-11820]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0314]
RIN 1625-AA00

Safety Zone; July 4th Holiday Fireworks on the Miles River, St.
Michaels, MD

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish a temporary safety
zone for certain waters of the Miles River. This action is necessary to
provide for the safety of life on these navigable waters of the Miles
River at St. Michaels, MD, on July 3, 2021, (with alternate date of
July 4, 2021), during fireworks displays to commemorate the July 4th
holiday. This proposed rulemaking would prohibit persons and vessels
from being in this safety zone unless authorized by the Captain of the
Port Maryland-National Capital Region or a designated representative.
We invite your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before June 22, 2021.

ADDRESSES: You may submit comments identified by docket number USCG-
2021-0314 using the Federal eRulemaking Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email MST1 Shaun Landante, Sector
Maryland-National Capital Region Waterways Management Division, U.S.
Coast Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On May 4, 2021, the Drew Landis Memorial Fireworks Fund, Inc. of
St. Michaels, MD, notified the Coast Guard that it will be conducting a
fireworks display from 9 p.m. to 9:30 p.m. on July 3, 2021. The
fireworks are to be launched from a fireworks barge located in the
Miles River, near the entrance to Long Haul Creek, at St. Michaels, MD.
In the event of inclement weather, the fireworks display will be
scheduled for July 4, 2021. Hazards from the fireworks display include
accidental discharge of fireworks, dangerous projectiles, and falling
hot embers or other debris. The COTP Maryland-National Capital Region
has determined that potential hazards associated with the fireworks to
be used in this display would be a safety concern for anyone within 420
feet of the fireworks barge.
    The Coast Guard is requesting that interested parties provide
comments within a shortened comment period of 15 days instead of the
typical 30 days for this notice of proposed rulemaking. The Coast Guard
believes the 15-day comment period still provides for a reasonable
amount of time for interested parties to review the proposal and
provide informed comments on it while also ensuring that the Coast
Guard has time to review and respond to any significant comments and
has a final rule in effect in time for the scheduled event.
    The Coast Guard is proposing this rulemaking under authority in 46
U.S.C. 70034 (previously 33 U.S.C. 1231).

III. Discussion of Proposed Rule

    The COTP is proposing to establish a temporary safety zone for
certain navigable waters within the Miles River and would be enforced
from 8 p.m. to 10:30 p.m. on July 3, 2021, or if necessary due to
inclement weather, from 8 p.m. to 10:30 p.m. on July 4, 2021. The
safety zone would cover all navigable waters of the Miles River within
420 feet of a barge in approximate position latitude 38[deg]47'55.10''
N, longitude 076[deg]12'43.75'' W, located at the entrance to Long Haul
Creek, at St. Michaels, MD. The duration of the zone is intended to
ensure the safety of vessels and these navigable waters before, during,
and after the scheduled 9 to 9:30 p.m. on July 3, 2021 fireworks
display.
    No vessel or person would be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. The regulatory text we are proposing appears at the end
of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders, and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the size,
duration, and time-of-day of the safety zone, which would impact a
small designated area of the Miles River for a total no more than 2.5

enforcement-hours, during the evening when vessel traffic is normally
low. This waterway supports mainly recreational vessel traffic, which
at its peak, occurs during the summer season. Moreover, the Coast Guard
will issue Local Notices to Mariners and a Broadcast Notice to Mariners
via VHF-FM marine channel 16 about the zones.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please call or email the person listed in the FOR FURTHER INFORMATION
CONTACT section. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a
temporary safety zone lasting 2.5 total enforcement hours that would
prohibit entry within a portion of the Miles River. Normally such
actions are categorically excluded from further review under paragraph
L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01,
Rev. 1. A preliminary Record of Environmental Consideration supporting
this determination is available in the docket. For instructions on
locating the docket, see the ADDRESSES section of this preamble. We
seek any comments or information that may lead to the discovery of a
significant environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, call or email the person
in the FOR FURTHER INFORMATION CONTACT section of this document for
alternate instructions.
    We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have
provided. For more about privacy and submissions in response to this
document, see DHS's eRulemaking System of Records notice (85 FR 14226,
March 11, 2020).
    Documents mentioned in this NPRM as being available in the docket,
and public comments, will be in our online docket at https://www.regulations.gov and can be viewed by following that website's
instructions. We review all comments received, but we will only post
comments that address the topic of the proposed rule. We may choose not
to post off-topic, inappropriate, or duplicate comments that we
receive. If you go to the online docket and sign up for email alerts,
you will be notified when comments are posted or a final rule is
published.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T05-0314 to read as follows:

Sec.  165.T05 -0314   Safety Zone; July 4th Holiday Fireworks on the
Miles River, St. Michaels, MD.

    (a) Location. The following area is a safety zone: All navigable
waters of the Miles River, within 420 feet of a fireworks barge in
approximate position latitude 38[deg]47'55.10'' N, longitude
076[deg]12'43.75'' W, located at the entrance to Long Haul Creek, at
St. Michaels, MD.
    (b) Definitions. As used in this section--
    Captain of the Port (COTP) means the Commander, U.S. Coast Guard
Sector Maryland-National Capital Region.
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty officer, or other officer
operating a Coast Guard vessel and a Federal, State, and local officer
designated by or assisting the Captain of the Port Maryland-National
Capital Region (COTP) in the enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by telephone at<PHONE_NUMBER> or on Marine Band Radio
VHF-FM channel 16 (156.8 MHz). Those in the safety zone must comply
with all lawful orders or directions given to them by the COTP or the
COTP's designated representative.
    (d) Enforcement officials. The U.S. Coast Guard may be assisted in
the patrol and enforcement of the safety zone by Federal, State, and
local agencies.
    (e) Enforcement period. This safety zone will be enforced from 8
p.m. to 10:30 p.m. on July 3, 2021. If necessary due to inclement
weather on July 3, 2021, it will be enforced from 8 p.m. to 10:30 p.m.
on July 4, 2021.

    Dated: June 1, 2021.
David E. O'Connell,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2021-11820 Filed 6-4-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: October 14, 2010 (Volume 75, Number 198)]
[Notices]
[Page 63229-63231]
[DOCID:fr14oc10-126]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63063; File No. SR-NASDAQ-2010-126]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change to
Make a Conforming Change to NASDAQ Rules

October 7, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on October 1, 2010, The NASDAQ Stock Market LLC (``NASDAQ'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NASDAQ proposes to make a conforming change to Rule 4758 to reflect
prior effectiveness of filings allowing routing of orders to a facility
of an exchange that is an affiliate of NASDAQ. NASDAQ proposes to
implement the rule change concurrent with the launch of cash equity
trading on NASDAQ OMX PSX, which is currently scheduled to occur on
October 8, 2010. The text of the proposed rule change is available at
http://nasdaq.cchwallstreet.com/, at NASDAQ's principal office, and at
the Commission's Public Reference Room.

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

    In its filing with the Commission, NASDAQ included statements
concerning the purpose of, and basis for, the proposed rule change. The
text of these statements may be examined at the places specified in
Item III below, and is set forth in Sections A, B, and C below.

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

1. Purpose
    The NASDAQ OMX Group, Inc. (``NASDAQ OMX'') owns three U.S.
registered securities exchanges--NASDAQ, NASDAQ OMX PHLX, Inc.
(``PHLX'') and NASDAQ OMX BX, Inc. (``BX''). In addition, NASDAQ OMX
currently indirectly owns Nasdaq Execution Services, LLC (``NES''), a
registered broker-dealer and a member of PHLX. Thus, NES is an
affiliate of each of NASDAQ, PHLX and BX.
    PHLX has received approval to launch NASDAQ OMX PSX (``PSX'') \3\
as a new platform for trading NMS stocks (as defined in Rule 600 under
Regulation NMS).\4\ Although PSX will not route to other market
centers, PSX will receive orders routed to it by other market centers,
including NASDAQ.
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    \3\ Securities Exchange Act Release No. 62877 (September 9,
2010), 75 FR 56633 (September 16, 2010) (SR-PHLX-2010-79).
    \4\ 17 CFR 242.600.
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    In SR-NASDAQ-2010-100,\5\ NASDAQ submitted a proposed rule change
that authorized it to route orders to PSX through NES without checking
the NASDAQ book. In addition, in SR-PHLX-2010-79, PHLX received
approval, on a pilot basis, to receive orders routed to it by NES that
did not check the NASDAQ book prior to routing.\6\ The change to NASDAQ
rules was reflected in an amendment to Rule 4751, but should have also
been reflected in an amendment to Rule 4758. Accordingly, NASDAQ is
submitting this rule change to make the conforming change.
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    \5\ Securities Exchange Act Release No. 62736 (August 17, 2010),
75 FR 51861 (August 23, 2010) (SR-NASDAQ-2010-100).
    \6\ Supra n.3.
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2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\7\ in general, and with Section
6(b)(5) of the Act,\8\ in particular, in that the proposal is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. The proposed rule change
would make a conforming change to NASDAQ rules to reflect previously
adopted rule changes.
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    \7\ 15 U.S.C. 78f.
    \8\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(6) thereunder.\10\ NASDAQ requests that the Commission waive the
30-day pre-operative delay contained in Exchange Act Rule 19b-
4(f)(6)(iii).\11\ NASDAQ requests such a waiver because the proposed
rule change merely conforms the text of Rule 4758 to rule changes made
by SR-NASDAQ-2010-100 and SR-PHLX-2010-79 that have already become
effective, and such waivers will allow the proposed rule change to be
in effect on October 8, 2010, the date on which trading will commence
on PSX. The Commission believes that waiving the 30-day operative delay
\12\ is consistent with the protection of investors and the public
interest. Accordingly, the Commission designates the proposal operative
upon filing.
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ 17 CFR 240.19b-4(f)(6)(iii).
    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2010-126 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2010-126. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, on
official business

days between the hours of 10 a.m. and 3 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; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NASDAQ-2010-126 and should be submitted on or before November 4, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-25863 Filed 10-13-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Notices]
[Pages 7035-7036]
[FR Doc No: 2018-03195]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9974-53-ORD; Docket ID No. EPA-HQ-ORD-2017-0747]

Availability of the Integrated Risk Information System (IRIS)
Assessment Plan for Uranium; correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period; Correction.

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SUMMARY: The Environmental Protection Agency (EPA) announced a 30-day
public comment period in the Federal Register of January 31, 2018,
associated with the draft IRIS Assessment Plan for Uranium. The
announcement contained an incorrect docket number.

DATES: The 30-day public comment period began on January 31, 2018, and
ends March 2, 2018. Comments must be received on or before March 2,
2018.

ADDRESSES: The IRIS Assessment Plan for Uranium, will be available via
the internet on IRIS' website at https://cfpub.epa.gov/ncea/iris2/chemicalLanding.cfm?substance_nmbr=259 and in the public docket at
http://www.regulations.gov, Docket ID: EPA-HQ-ORD-2017-0747.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the ORD Docket at the EPA Headquarters Docket Center;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email:
[email protected].
    For technical information on the draft IRIS Assessment Plan for
Uranium, contact Dr. James Avery, NCEA; telephone:<PHONE_NUMBER>; or
email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Correction

    In the Federal Register of January 31, 2018, in FR Doc. 2018-01915,
on page 4479, on the first and third columns, correct the ``For Further
Information Contact'' and ``How To Submit Technical Comments to the
Docket at http://www.regulations.gov'' caption to read: FOR FURTHER
INFORMATION CONTACT: For information on the public comment period,
contact the ORD Docket at the EPA Headquarters Docket Center;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email:
[email protected].

SUPPLEMENTARY INFORMATION: Submit your comments, identified by Docket
ID No. EPA-HQ-ORD-2017-0747 for uranium, by one of the following
methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email: [email protected].
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center (ORD Docket), Mail Code: 28221T, 1200 Pennsylvania Avenue NW,
Washington, DC 20460. The phone number is<PHONE_NUMBER>.
     Hand Delivery: The ORD Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Avenue NW, Washington, DC 20229.
    The EPA Docket Center 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<PHONE_NUMBER>.
Deliveries are only accepted during the docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. If you provide comments by mail or hand delivery,
please submit three copies of the comments. For attachments, provide an
index, number pages consecutively

with the comments, and submit an unbound original and three copies.
    Instructions: Direct your comments to docket number EPA-HQ-ORD-
2017-0747 for uranium. Please ensure that your comments are submitted
within the specified comment period. Comments received after the
closing date will be marked ``late,'' and may only be considered if
time permits. It is EPA's policy to include all comments it receives in
the public docket without change and to make the comments available
online at www.regulations.gov, including any personal information
provided, unless a comment includes information claimed to be
Confidential Business Information (CBI) or other information for which
disclosure is restricted by statute. Do not submit information through
www.regulations.gov or email that you consider to be CBI or otherwise
protected. The www.regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the ORD Docket in the EPA
Headquarters Docket Center.

    Dated: February 7, 2018.
Tina Bahadori,
Director, National Center for Environmental Assessment.
[FR Doc. 2018-03195 Filed 2-15-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Rules and Regulations]
[Pages 31177-31178]
[FR Doc No: 2021-12236]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 61

[Docket ID FEMA-2018-0026]
RIN 1660-AA95

National Flood Insurance Program: Conforming Changes To Reflect
the Biggert-Waters Flood Insurance Reform Act of 2012 (BW-12) and the
Homeowners Flood Insurance Affordability Act of 2014 (HFIAA), and
Additional Clarifications for Plain Language; Correction

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security (DHS).

ACTION: Final rule; correction.

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SUMMARY: On July 20, 2020, FEMA published in the Federal Register a
final rule revising the National Flood Insurance Program (NFIP)
regulations to codify certain provisions of the Biggert-Waters Flood
Insurance Reform Act of 2012 and the Homeowner Flood Insurance
Affordability Act of 2014, and to clarify certain existing NFIP rules
relating to NFIP operations and the Standard Flood Insurance Policy.
This final rule provides corrections to those instructions, to be used
in lieu of the information published July 20.

DATES: This correction is effective October 1, 2021.

ADDRESSES: The docket for this rulemaking is available for inspection
using the Federal eRulemaking Portal at http://www.regulations.gov and
can be viewed by following that website's instructions.

FOR FURTHER INFORMATION CONTACT: Kelly Bronowicz, Director,
Policyholder Services Division, Federal Insurance and Mitigation
Administration, Federal Emergency Management Agency, 400 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In FR Doc. 2020-09260, beginning on page
43946 in the Federal Register of Monday, July 20, 2020, the following
corrections are made:

Appendix A(1) to Part 61 [Corrected]

0
1. On page 43968, in the second column, in appendix A(1) to part 61,
the signatory ``Administrator, Federal Insurance and Mitigation
Administration'' is corrected to read ``Federal Insurance and
Mitigation Administration''.

Appendix A(2) to Part 61 [Corrected]

0
2. On page 43976, in the second column, in appendix A(2) to part 61,
the signatory ``Administrator, Federal Insurance and Mitigation
Administration'' is corrected to read ``Federal Insurance and
Mitigation Administration''.

Appendix A(3) to Part 61 [Corrected]

0
3. On page 43985, in the first column, in appendix A(3) to part 61, the
signatory ``Administrator, Federal Insurance and Mitigation
Administration'' is corrected to read ``Federal Insurance and
Mitigation Administration''.

Deanne B. Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-12236 Filed 6-10-21; 8:45 am]
BILLING CODE 9111-52-P


[Federal Register Volume 86, Number 129 (Friday, July 9, 2021)]
[Notices]
[Pages 36309-36310]
[FR Doc No: 2021-14606]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92320; File No. SR-NYSEArca-2021-28]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To List and Trade the Shares of ConvexityShares Daily 1.5x
SPIKES Futures ETF Under NYSE Arca Rule 8.200-E (Trust Issued Receipts)

July 2, 2021.
    On May 13, 2021, NYSE Arca, Inc. (``NYSE Arca'') 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 of the ConvexityShares Daily 1.5x SPIKES Futures ETF under NYSE
Arca Rule 8.200-E, Commentary .02 (Trust Issued Receipts). The proposed
rule change was published for comment in the Federal Register on May
26, 2021.\3\ The

Commission has received no comment letters on 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. 91949 (May 20,
2021), 86 FR 28420.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is July 10, 2021. The Commission is extending this 45-day time period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).0
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change. Accordingly, the
Commission, pursuant to Section 19(b)(2) of the Act,\5\ designates
August 24, 2021 as the date by which the Commission shall either
approve or disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-NYSEArca-2021-28).
---------------------------------------------------------------------------

    \5\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-14606 Filed 7-8-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Rules and Regulations]
[Pages 78562-78568]
[FR Doc No: 2022-27715]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0301; FRL-9321-01-OCSPP]

Simazine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
simazine in or on citrus fruits (crop group 10-10), pome fruits (crop
group 11-10), stone fruits (crop group 12-12), and tree nuts (crop
group 14-12) and amends the tolerance for residues in or on almond
hulls. Syngenta Crop Protection, LLC requested these tolerances under
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 22, 2022. Objections and
requests for hearings must be received on or before February 21, 2023,
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-2012-0301, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton 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 the
Public Reading Room and the OPP Docket is<PHONE_NUMBER>. For the
latest status information on EPA/DC services and docket access, visit
https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration
Division (Mail Code 7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

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 Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

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-2012-0301 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
February 21, 2023. 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-2012-0301, by one of
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 25, 2012 (77 FR 43562) (FRL-9353-
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
(PP2F8006) by Syngenta Crop Protection, LLC, P.O. Box 18300,
Greensboro, NC 27419-8300. The petition requested that 40 CFR 180.213
be amended by establishing tolerances for residues of the herbicide
simazine, in or on citrus fruits (crop group 10), pome fruits (crop
group 11), stone fruits (crop group 12), and tree nuts (crop group 14,
except almond hull) at 0.05, 0.03, 0.1, and 0.07 parts per million
(ppm), respectively, and amending the tolerance for residues in or on
almond hulls to 3 ppm. In addition, the petition requested the removal
of tolerances for apple, hazelnut, peach, pecan, plum, and walnut at
0.20 ppm, and for almond, cherry, grapefruit, lemon, macadamia nut,
orange, and pear at 0.25 ppm, upon establishment of the new tolerances.
That document referenced a summary of the petition prepared by Syngenta
Crop Protection, LLC, the registrant, which is available in the docket,
https://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
determined that the residue data for the citrus fruit crop group
support a tolerance level of 0.04 ppm, not 0.05 ppm as proposed by the
registrant, and a level of 0.05 ppm not 0.07 ppm is being established
for crop group 14-12. 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 simazine including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with simazine 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.
Simazine and Its Chlorinated Metabolites
    Simazine is a chlorotriazine herbicide that is similar in structure
to atrazine and propazine. These chlorotriazine herbicides, along with
their common chlorinated metabolites, have been determined by the EPA
to share a common neuroendocrine mechanism of toxicity and constitute
the triazine common mechanism group (CMG). Because of the similar
structures and metabolites among these three pesticides, they are also
assumed to be of equal potency for neuroendocrine effects. Therefore,
the more robust toxicological database for atrazine has been used to
characterize neuroendocrine toxicity, and for endpoint selection, for
all of these compounds. The neuroendocrine endpoint chosen for these
chemicals is attenuation of the luteinizing hormone (LH) surge after 4
days of exposure, the most sensitive effect which protects for other
downstream adverse endocrine related toxicological effects and
potential effects on non-endocrine systems.
    EPA has concluded that the available data do not identify a unique
quantitative susceptibility in the developing organism. None of the
available studies with atrazine evaluating rats exposed during
gestation, lactation, or in the peri-pubertal periods have shown
effects at doses lower than those eliciting the LH surge attenuation in
adult female rats after 4 days of exposure. Additionally, the POD,
based upon attenuation of the LH surge, is protective against adverse
reproductive/developmental outcomes such as delays in onset of puberty,
disruption of ovarian cyclicity and inhibition of prolactin release.
For other potential adverse outcomes, the effects occurred at dose
levels approximately one order of magnitude or higher than the no
observed adverse effect level (NOAEL)/lowest observed adverse effect
level (LOAEL) for LH surge attenuation. As simazine has been classified
as ``Not likely to be carcinogenic to humans,'' cancer risk is not a
concern and a quantitative cancer risk assessment was not conducted.
Hydroxysimazine and Its Hydroxylated Metabolites
    In addition to the chlorotriazine metabolites, simazine also has an
analogous series of metabolites, known as the hydroxy metabolites, in
which the chlorine is replaced by a hydroxy moiety. While the hydroxy
metabolites are all considered to be of equal toxicity to each other,
these compounds exhibit different toxicological properties than the
chlorinated metabolites, and risk estimates are therefore quantified
separately using an endpoint and POD based on hydroxyatrazine. The
available data indicate that the kidney is the primary target organ for
hydroxysimazine and its metabolites.
    There is no evidence for increased susceptibility in the young
following in utero exposure or carcinogenicity in the available data
for hydroxysimazine and its metabolites.
    A complete discussion of the toxicological profile for simazine and
specific information on the studies received and the nature of the
adverse effects caused by simazine as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document titled Simazine. ``Human Health Risk
Assessment for Registration Review and to Support the Registration of
Proposed Uses on Citrus Fruit (Crop Group 10-10), Pome Fruit (Crop
Group 11-10), Stone Fruit (Crop Group 12-12), Tree Nuts (Crop Group 14-
12), and Tolerance Amendment for Almond Hulls'' in docket ID number
EPA-HQ-OPP-2013-0251.

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 https://www.epa.gov/science-and-assessing-pesticide-risks.
    The toxicological endpoints for simazine used for human risk
assessment and an explanation for how the Agency calculated those PODs
can be found in the Simazine Human Health Risk Assessment, sections
4.6-4.84, 5.4.2.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to simazine, EPA considered exposure under the petitioned-for
tolerances as well as all existing simazine tolerances in 40 CFR
180.213. EPA assessed dietary exposures from simazine and its
chlorinated metabolites separately from exposures to hydroxysimazine
and the hydroxylated metabolites due to the different toxicities
observed for the compounds. The assessments of residues of these
substances in food were conducted 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 simazine and its
chlorinated metabolites but not for hydroxysimazine and the
hydroxylated metabolites.
    In estimating acute dietary exposure to residues of simazine and
its chlorinated metabolites, EPA used 2003-2008 food consumption
information from the United States Department of Agriculture's (USDA's)
National Health and Nutrition Examination Survey, What We Eat in
America, (NHANES/WWEIA). As to anticipated residue levels in food, the
acute assessment was refined using field trial data, default processing
factors, and assumed that 100% of the proposed and registered
commodities were treated.
    ii. Four-day/Chronic exposure. Typically, chronic exposure is
assessed, but for simazine and its chlorinated metabolites a four-day
exposure duration is appropriate since the toxicological effect
(attenuation of the LH surge) occurs after four days of exposure and is
protective of exposures of longer durations. In conducting the four-day
dietary exposure assessment, EPA used the food consumption data from
the United States Department of Agriculture's (USDA's) National Health
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA). As to anticipated residue levels in food, four-day dietary
assessments were partially refined using field trial studies, default
processing factors, and assumed that 100% of the proposed and
registered commodities were treated.
    In conducting the chronic dietary exposure assessment for
hydroxysimazine and its hydroxylated metabolites, EPA used the food
consumption data from USDA's NHANES/WWEIA. As to anticipated residue
levels in food, the chronic dietary assessment for hydroxysimazine and
its hydroxylated metabolites was refined using residue levels from
metabolism studies, default processing factors, and average percent
crop treated data.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that neither simazine nor hydroxysimazine poses a cancer risk
to humans. Therefore, a dietary exposure assessment for the purpose of
assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The acute and four-day steady state dietary assessment for simazine
assumed 100% crop treated for all registered and requested crops. The
chronic (background) assessments for simazine and its chlorinated
metabolites and for hydroxysimazine and its hydroxylated metabolites
incorporated average percent crop treated estimates as follows: almond:
10%; apple: 10%; avocado: 5%; blueberry: 15%; caneberry: 45%; cherry:
5%; field corn: 5%; sweet corn: 2.5%; grapefruit: 20%; grape: 25%;
hazelnut: 35%; lemon: 10%; nectarine: 5%; olive: 15%; orange: 25%;
peach: 15%; pear: 10%; pecan: 5%; plums/prunes: 2.5%; strawberry: 5%;
tangerine: 5%; and walnut: 20%. 100% CT was assumed for the remaining
commodities.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figures for each existing
use are derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding up
to the nearest 5%, except for those situations in which the average PCT
is less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which simazine may be applied in a particular area.
    2. Dietary exposure from drinking water. Extensive and robust
surface and groundwater monitoring data are available for triazines
(including simazine) and were included in the drinking water
assessment. The Agency also used screening-level water exposure models
in the dietary exposure analysis and risk assessment for simazine in
drinking water. These simulation models take into account data on the
physical, chemical, and fate/transport characteristics of simazine.
Estimated drinking water concentrations (EDWCs) are based on total
triazine

residues, which include atrazine, propazine, and simazine, and all the
related metabolites, and are not just based on simazine and its
chlorinated and hydroxylated metabolites, these EDWCs may be considered
high-end estimates for the simazine risk assessment. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-risk-assessment.
    Based on the Pesticide Root Zone Model Ground Water (PRZM GW), the
surface water concentration calculator (SWCC), and FQPA Index Reservoir
Screening Tool (FIRST) modeling, the EDWCs of simazine are estimated to
be 265-610 parts per billion (ppb) for surface water and 92.6-100 ppb
for groundwater for acute exposure; 265-585 ppb for surface water and
92.6-100 ppb for groundwater for the 4-day exposures; and 76-104 ppb
for surface water and 5.11-7.33 ppb for groundwater for chronic
exposures for non-cancer assessments.
    A drinking water level of comparison (DWLOC) approach to aggregate
risk was used to calculate the amount of exposure available in the
total `risk cup' for drinking water after accounting for any exposures
from food and/or residential use. The DWLOCs are then compared to the
EDWCs. If the DWLOCs are greater than the EDWCs, there is no aggregate
risk of concern. The use of a DWLOC approach facilitates determining
aggregate risks when there are multiple EDWCs or when there are
potential aggregate risk estimates of concern. Water ingestion rates
are included in the acute and chronic DWLOC calculations. These values
vary with population subgroup, the duration time of interest, and the
exposure percentile applicable for regulation. These values were
determined directly from the NHANES/WWEIA water consumption data,
making use of the appropriate exposure durations and percentiles. For
the simazine 4-day aggregate assessments, the DWLOC approach used a
reciprocal MOE calculation method since the target MOEs (level of
concern based on the total uncertainty factor) are the same for all
relevant sources of exposure. For the four-day assessment, water
consumption is accounted for in the PBPK model when deriving the
drinking water PODs and is not included in the DWLOC calculation.
Infants and children were assumed to consume water 6 times a day, with
a total consumption volume of 0.688557 liters per day (L/day). Youths
and female adults were assumed to consume water 4 times a day, with a
total consumption volume of 1.71062 L/day.
    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). Simazine is currently
registered for the following uses that could result in residential
exposures: residential turf. There are no residential handler combined
(dermal + inhalation) risk estimates of concern for simazine.
    There is potential for short-term post-application exposure for
individuals as a result of being in an environment that has been
previously treated with simazine. There were post-application dermal
risk estimates of concern for adults and children 1 to <2 years old and
combined (dermal + incidental oral) risk estimates of concern for
children 1 to <2 years old (LOC = 30) from high contact activities on
treated turf. These scenarios are considered worst-case and are
protective of all other exposure scenarios.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/operating-procedures-residential-pesticide.
    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.''
    Simazine is a chlorotriazine herbicide. A cumulative risk
assessment with the chlorotriazines atrazine, simazine, propazine, and
their common metabolites is available at https://www.regulations.gov,
Docket ID EPA-HQ-OPP-2013-0266.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. For simazine and its
chlorinated metabolites, there was no increased quantitative or
qualitative susceptibility in any of the guideline studies on atrazine
in the rat, and there was no increased quantitative susceptibility in
the rabbit study. Although there was increased qualitative
susceptibility in the atrazine rabbit study, increased resorptions
(deaths) at a dose level that resulted in decreased body-weight gain
and clinical signs in the maternal animal the observed effects occur at
higher doses than the benchmark dose lower confidence limit (BMDL) of
2.42 mg/kg/day used to assess risk. The BMDL of 2.42 mg/kg/day is
protective of developmental effects in the rabbit.
    For hydroxysimazine, there was no evidence of increased qualitative
or quantitative susceptibility in the available toxicological data on
this metabolite including a developmental rat study and female and male
pubertal assays.
    3. Conclusion. For simazine and its chlorinated metabolites, 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 based on lack of increased sensitivity for infants and children.
That decision is based on the following findings:
    i. The toxicity database for the chlorotriazines (including
simazine) and their metabolites is considered complete.
    ii. Chlorotriazines have an established neuroendocrine mode of
action and LH attenuation is the most sensitive endpoint identified in
the database. LH attenuation is protective of potential health outcomes
associated with chlorotriazines.
    iii. There was no increased quantitative or qualitative
susceptibility in any of the guideline studies on atrazine in the rat,
and there was no increased quantitative susceptibility in the rabbit
study. Although there was increased qualitative susceptibility in the
atrazine rabbit study, the observed effects occur at higher doses than
the benchmark dose lower confidence limit (BMDL) of 2.42 mg/kg/day used
to assess risk. The BMDL of 2.42 mg/kg/day is protective of
developmental effects in the rabbit.
    iv. There are no residual uncertainties identified in the exposure
databases.

EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to simazine in drinking
water. These assessments will not underestimate the exposure and risks
posed by simazine.
    For hydroxysimazine, 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 based on lack of increased sensitivity for
infants and children. That decision is based on the following findings:
    i. The toxicity database for hydroxysimazine is complete for a
metabolite.
    ii. Hydroxysimazine does not have a neuroendocrine mode of action
as the parent chlorotriazines.
    iii. There was no evidence of increased qualitative or quantitative
susceptibility in the available toxicological data on this metabolite
including a developmental rat study and female and male pubertal
assays.
    iv. There are no residual uncertainties identified in the exposure
databases.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Simazine and its chlorinated metabolites. The acute
aggregate assessment considers food and water exposures. The acute
DWLOC for females 13 to 49 years old is 5,500 ppb. The acute DWLOC is
greater than the acute EDWCs for total chlorotriazines TCTs in surface
water or ground water (EDWC range = 100-610 ppb); there is no acute
aggregate risk of concern.
Hydroxysimazine and its Hydroxylated Metabolites
    No toxicological effects attributable to a single dose were
identified for hydroxysimazine; therefore, an acute endpoint has not
been identified and no risk is expected from this exposure scenario.
    2. Four-day/Chronic risk. Simazine and its chlorinated metabolites.
The four-day aggregate risk assessments are protective for short-term,
intermediate-term, and chronic aggregate risks since the POD and
endpoint used for the four-day assessment are the most sensitive for
any duration, and are, therefore, protective of longer durations of
exposure. The calculated four-day DWLOCs are all greater than the 4-day
EDWCs for TCTs in surface water or ground water; there are no four-day
aggregate risks of concern.
Hydroxysimazine and its Hydroxylated Metabolites
    The chronic aggregate risk assessment for the hydroxysimazine
considers food and water exposures. No residential exposures to the
hydroxysimazine metabolite are expected from the simazine uses. The
lowest chronic DWLOC for hydroxysimazine is for all infants (<1 year
old) at 1300 ppb. The chronic DWLOCs are greater than the chronic EDWCs
for total hydroxytriazines (THTs) in surface water or ground water
(EDWC range = 7.33-76 ppb); there is no chronic aggregate risk of
concern.
    3. Aggregate cancer risk for U.S. population. Simazine has been
classified as ``Not likely to be carcinogenic to humans.''
Hydroxysimazine is also not likely to pose cancer risks based on the
lack of cancer effects seen in available studies.
    4. 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 simazine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (LC-MS/MS) is available to enforce
the tolerance expression.

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 simazine.

C. Revisions to Petitioned-For Tolerances.

    The submitted residue data support a tolerance level of 0.04 ppm
for the citrus fruit crop group. The petitioner's proposed tolerance
level of 0.05 ppm was based on using the maximum combined residue level
of 0.038 ppm (one grapefruit sample) in the Organisation for Economic
Co-operation and Development (OECD) tolerance calculation procedures.
EPA's approach to tolerance calculations uses the average field trial
value of 0.034 ppm, which warrants a tolerance of level of 0.04 ppm
instead. Also, although the proposed tolerance level of 0.07 ppm for
crop group 14-12 is supported by OECD tolerance calculations, EPA is
establishing the tolerance at 0.05 ppm to harmonize with the Canadian
MRL. Due to the conservatisms in the OECD calculator, the tolerance
level of 0.05 ppm will be sufficient to cover residues of simazine in
or on food resulting from legal applications of the pesticide.

D. International Trade Considerations

    In this Final Rule, EPA is reducing the existing tolerances for the
commodities of almond from 0.25 to 0.05 ppm as part of nut, tree, group
14-12; apple from 0.2 to 0.03 ppm as part of fruit, pome, group 11-10;
cherry from 0.25 to 0.1 ppm as part of fruit, stone, group 12-12;
grapefruit, lemon, and orange from 0.25 to 0.04 ppm as part of fruit,
citrus, group 10-10; hazelnut, nut, macadamia, pecan, and walnut from
0.2 to 0.05 ppm as part of nut, tree, group 14-12; peach and plum from
0.2 to 0.1 ppm as part of fruit, stone, group 12-12; and pear from 0.25
to 0.03 as part of fruit, pome, group 11-10. The Agency is reducing
these tolerances because available residue data demonstrates that the
new tolerances are sufficient to cover residues on these commodities.
    In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the
WTO of this revision in order to satisfy its obligation. In addition,
the SPS Agreement requires that Members provide a ``reasonable
interval'' between the publication of a regulation subject to the
Agreement and its entry into force to allow time for producers in
exporting Member countries to adapt to the new requirement. At this
time, EPA is establishing an expiration date for the existing
tolerances to allow those

tolerances to remain in effect for a period of six months after the
effective date of this final rule, in order to address this
requirement. After the six-month period expires, residues of simazine
on grapefruit, lemon, and orange cannot exceed the citrus fruits (crop
group 10-10) tolerance of 0.04 ppm; apple and pear cannot exceed the
pome fruits (crop group 11-10) tolerance of 0.03 ppm; cherry, peach,
and plum cannot exceed the stone fruits (crop group 12-12) tolerance of
0.1 ppm; and almond, hazelnut, nut, macadamia, pecan, and walnut cannot
exceed the tree nuts (crop group 14-12) tolerance of 0.05 ppm.
    This reduction in tolerance levels is not discriminatory; the same
food safety standard contained in the FFDCA applies equally to
domestically produced and imported foods. The new tolerance levels are
supported by available residue data.

V. Conclusion

    Therefore, tolerances are established for residues of simazine in
or on Fruit, citrus, group 10-10, Fruit, pome, group 11-10, Fruit,
stone, group 12-12, and Nut, tree, group 14-12 at 0.04 ppm, 0.03 ppm,
0.10 ppm, and 0.05 ppm, respectively, and the tolerance for Almond,
hulls is amended to 3 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes and modifies 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 action has been
exempted from review under Executive Order 12866, this action 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 action 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 action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(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 (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: December 16, 2022.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

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. Revise Sec.  180.213 to read as follows:

Sec.  180.213  Simazine; tolerances for residues.

    (a) General. Tolerances are established residues of the herbicide
simazine, including its metabolites and degradates, in or on the
commodities in table 1 to this paragraph (a). Compliance with the
tolerance levels specified in table 1 to this paragraph (a) is to be
determined by measuring only the sum of simazine, 6-chloro-N,N'-
diethyl-1,3,5-triazine-2,4-diamine, and its metabolites 6-chloro-N-
ethyl-1,3,5-triazine-2,4-diamine, and 6-chloro-1,3,5-triazine-2,4-
diamine, calculated as the stoichiometric equivalent of simazine, in or
on the commodity.

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond \1\..................................................        0.25
Almond, hulls...............................................           3
Apple \1\...................................................        0.20
Avocado.....................................................        0.20
Blackberry..................................................        0.20
Blueberry...................................................        0.20
Cattle, meat................................................        0.03
Cattle, meat byproducts.....................................        0.03
Cherry \1\..................................................        0.25
Corn, field, forage.........................................        0.20
Corn, field, grain..........................................        0.20
Corn, field, stover.........................................        0.25
Corn, pop, grain............................................        0.20
Corn, pop, stover...........................................        0.25
Corn, sweet, forage.........................................        0.20
Corn, sweet, kernel plus cob with husks removed.............        0.25
Corn, sweet, stover.........................................        0.25
Cranberry...................................................        0.25
Currant.....................................................        0.25
Egg.........................................................        0.03
Fruit, citrus, group 10-10..................................        0.04
Fruit, pome, group 11-10....................................        0.03
Fruit, stone, group 12-12...................................         0.1
Goat, meat..................................................        0.03
Goat, meat byproducts.......................................        0.03
Grape.......................................................        0.20
Grapefruit \1\..............................................        0.25
Hazelnut \1\................................................        0.20
Horse, meat.................................................        0.03
Horse, meat byproducts......................................        0.03
Lemon \1\...................................................        0.25

Loganberry..................................................        0.20
Milk........................................................        0.03
Nut, macademia \1\..........................................        0.25
Nut, tree, group 14-12......................................        0.05
Olive.......................................................        0.20
Orange \1\..................................................        0.25
Peach \1\...................................................        0.20
Pear \1\....................................................        0.25
Pecan \1\...................................................        0.20
Plum \1\....................................................        0.20
Raspberry...................................................        0.20
Sheep, meat.................................................        0.03
Sheep, meat byproducts......................................        0.03
Strawberry..................................................        0.25
Walnut \1\..................................................         0.2
------------------------------------------------------------------------
\1\ This tolerance expires on June 22, 2023.

    (b) through(d) [Reserved]

[FR Doc. 2022-27715 Filed 12-21-22; 8:45 am]
BILLING CODE 6560-50-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have not researched everything yet, so I need more time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I smoked cigarettes for over 30 years. I started vaping about 1 year ago and I breathe much better. My doctor also agrees that it is much better than smoking regular cigarettes. Of course, he did recommend that I cut out the nicotine. I am lowering my nicotine intake slowly.

It just worries me when the government gets involved into anything because they can't do anything right it seems. They are so wasteful and will most likely drive the prices through the roof because of the tobacco lobbyists. They are so corrupt that they are the most hated people on earth! Americans have a lower opinion of congress than satan! What, 6% approval?

I appreciate your consideration of my request and am happy to discuss this issue with you further.

Thanks, Robert E. Calk Jr.