[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Notices]
[Pages 62726-62728]
[FR Doc No: 2013-24636]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70627; File No. SR-NASDAQ-2013-130]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Adopt New Regulatory Fees Payable by Certain Listed Companies and
Applicants

October 8, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 \2\ thereunder, notice is hereby given
that on October 2, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by NASDAQ.
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 is proposing to adopt new regulatory fees payable by certain
listed companies and applicants.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, 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, the Exchange included statements
concerning the purpose of and basis for the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    NASDAQ proposes to adopt new regulatory fees applicable to certain
listed companies and applicants. Specifically, NASDAQ proposes to
require that an acquisition company that completes a business
combination pay a $15,000 substitution listing fee in connection with
the acquisition transaction. In addition, NASDAQ proposes to require
that an applicant that does not list within 12 months of submitting its
application pay a $5,000 additional application fee each subsequent 12
month period that the application remains pending. NASDAQ also proposes
to impose a $5,000 application fee on companies that transfer from the
NASDAQ Global or Global Select Market to the NASDAQ Capital Market.
Finally, NASDAQ proposes to impose a $5,000 review fee on companies
that submit a plan to regain compliance with certain listing
requirements.
Acquisition Companies
    NASDAQ Rule IM-5101-2 provides rules for the listing of a company
whose business plan is to complete one or more acquisitions. These
companies are required to maintain most of the proceeds of their
initial public offering in a deposit account until the company
completes one or more acquisitions representing at least 80% of the
value of the deposit account. In connection with each acquisition made
during this period, the acquisition company must notify NASDAQ about
the acquisition and NASDAQ staff must determine whether the combined
company will meet the requirements for initial listing. In conducting
this review, NASDAQ staff considers the quantitative requirements for
listing and also reviews for any public interest concerns the new
officers, directors and shareholders that will become associated with
the listed company as a result of the transaction.
    When NASDAQ initially adopted rules concerning the listing of
acquisition companies it determined not to charge an entry fee when the
company completes a business combination.\3\ As a result, because the
application review fee is a component of the entry fee, NASDAQ also
does not collect an application fee in connection with its review of
whether the acquisition company satisfies the initial listing
standards.\4\ However, while the acquisition company is already a
listed company, there are significant changes in its business,
management and ownership structure at the time of the acquisition,
necessitating a review that is substantially similar to the review
conducted for newly listing companies. NASDAQ staff spends considerable
time on such reviews.
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    \3\ See Securities Exchange Act Release No. 57685 (April 18,
2008), 73 FR 22191 (April 24, 2008) (Notice of Filing for SR-NASDAQ-
2008-013, proposing additional initial listing standards for Special
Purpose Acquisition Vehicles) at footnote 9 (noting that companies
would not be required to pay a new listing fee at the time of an
acquisition transaction).
    \4\ See Rules 5910(a) and 5920(a).
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    Accordingly, NASDAQ now proposes to include a business combination
described in IM-5101-2 in the definition of ``Substitution Listing
Events,'' and thus subject these transactions to the $15,000 fee
imposed on a Subsitution [sic] Listing Event in Rules 5910(f) and
5920(e). NASDAQ believes that this is appropriate, as the business
combination by an acquisition company is similar to other Substitution
Listing Events for which a fee is charged, such as a technical change
whereby the shareholders of the original company receive a share-for-
share interest in a new company.
    NASDAQ will implement this fee immediately. However, NASDAQ will
not charge this fee in connection with its review of any transaction
that was publicly announced in a press release or Form 8-K prior to
October 15, 2013.
Additional Application Fee
    NASDAQ Rules 5910(a) and 5920(a) impose application fees on
companies listing on NASDAQ. These fees are designed to recoup a
portion of the costs associated with NASDAQ's review of the company.
    NASDAQ has observed that when a company lists a substantial period
of time after it first submitted its applications, NASDAQ must complete
additional reviews of the application prior to the listing. These
additional reviews are substantially equivalent to the review for a
newly applying company and include, for example, additional reviews of
individuals associated with the company, staff monitoring of
disclosures and public filings by the applicant while its application
is pending, and often extensive discussions with the applicant. To
offset the costs associated with the ongoing monitoring and additional
reviews for companies whose application remains open for an extended
period, NASDAQ proposes to

require that an applicant that does not list within 12 months of
submitting its application pay an additional $5,000 application fee
each subsequent 12 month period. NASDAQ believes that the proposed
additional application fee may result in companies closing unrealistic
applications rather than maintaining such applications indefinitely.
    Like the current application fee, the proposed additional
application fee would be credited towards the entry fee payable upon
listing if the application remains open until such listing. Thus, for a
company that ultimately lists on NASDAQ, there would be no change in
the overall fee paid. If a company does not timely pay the additional
application fee, its application will be closed and it will be required
to submit a new application, and pay a new application fee, if it
subsequently reapplies.
    NASDAQ will implement this fee immediately, but will not charge any
company until October 15, 2014. This will assure that any company with
an application pending at the time of this filing will have at least
one year to list before they are charged the fee.
Capital Market Transfer Fee
    NASDAQ does not impose an entry fee on a company that transfers
from the NASDAQ Global Market to the NASDAQ Capital Market.\5\ As a
result, because the application fee is a component of the entry fee,
similar to the case noted above involving acquisition companies, NASDAQ
also has not collected an application fee for companies that transfer
from the Global to the Capital Market. However, the review of such
applications is often complicated and companies transferring from the
Global Market to the Capital Market are often experiencing business
challenges.\6\ As a result, to help offset a portion of the costs
associated with such reviews, NASDAQ now proposes to impose a $5,000
application fee for a company that submits an application to transfer
from the Global to the Capital Market.
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    \5\ Rule 5920(a)(7)(i). The NASDAQ Global Market also includes
the Global Select tier.
    \6\ In fact, many companies making such transfers do so in
connection with their failure to meet a Global Market continued
listing standard. Such companies would not also be subject to the
proposed compliance plan review fee discussed below.
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    NASDAQ will implement this fee for transfer applications submitted
after October 15, 2013. This period before implementation will allow
companies with an application in progress to finalize and submit that
application before the new fee is applicable.
    NASDAQ will implement this fee for transfer applications submitted
after October 15, 2013. This period before implementation will allow
companies with an application in progress to finalize and submit that
application before the new fee is applicable. [sic]
Compliance Plan Review Fee
    NASDAQ proposes to impose a $5,000 review fee on non-compliant
companies that submit a plan to regain compliance with certain of the
listing requirements. Rule 5810(c)(2) allows a listed company to submit
a plan to regain compliance when it fails to meet certain listing
requirements. NASDAQ dedicates considerable staff resources to
reviewing these plans of compliance. At present, the cost of that time
is allocated across all companies as part of the listing fee. In order
to allocate this cost more equitably to the individual companies who
directly benefit, NASDAQ proposes to adopt a $5,000 review fee for the
review of certain compliance plans.
    NASDAQ believes that the proposed compliance plan review fee is
appropriate because companies often have the ability to foresee non-
compliance with these listing requirements and take appropriate action
before becoming non-compliant. In addition, companies have a period of
time, generally either 45 or 60 days, before they must submit a plan to
regain compliance \7\ and, if a company achieves compliance during this
time, it would not be required to submit a plan or pay the proposed
compliance plan review fee. When a company does become non-compliant
and cannot cure the deficiency before the plan is due, NASDAQ's
experience is that the company's plan often requires detailed analysis
by staff to determine whether the plan can enable the company to regain
compliance in the near term.\8\ Depending on the underlying listing
requirement, NASDAQ staff may also need to expend time discussing the
viability of the plan with the company's outside auditor and advisors
and/or reviewing transactional documents.
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    \7\ Rule 5810(c)(2)(A).
    \8\ A company's plan with respect to a quantitative deficiency
may be for it to transfer from the Global Market to the Capital
Market, which has lower quantitative listing requirements. In this
case, the company must submit the application transfer fee in
proposed Rule 5920(a)(11), described above, but would not also pay a
compliance plan review fee.
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    NASDAQ does not propose to impose the compliance plan review fee on
plans to regain compliance with deficiencies from board of director and
board committee requirements where the company is not eligible for a
cure period, as described in Rule 5810(c)(2)(A)(iii) [sic]. NASDAQ's
experience is that these types of deficiencies often arise unexpectedly
from events outside the control of the company, such as the death or
resignation of a director. Further, NASDAQ has observed that the plans
to regain compliance with these deficiencies are typically straight
forward and do not require significant staff analysis. For example, a
typical plan might describe the hiring of a director search firm or
providing the resume of a director candidate who is concluding his or
her own due diligence on the company before agreeing to join the board.
As such, NASDAQ does not believe it is necessary to impose a plan
review fee in these situations.
    NASDAQ will implement this fee for plans submitted in response to
deficiency notifications sent after October 15, 2013.
2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\9\ in general and with Sections
6(b)(4) and (5) of the Act,\10\ in particular, in that it provides for
the equitable allocation of reasonable dues, fees, and other charges
among its members, issuers and other persons using its facilities, and
does not unfairly discriminate between customers, issuers, brokers or
dealers.
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    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(4) and (5).
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    NASDAQ believes that the proposed fees are reasonable because they
will better reflect NASDAQ's costs in reviewing applications and
compliance plans and help ensure adequate resources for NASDAQ's
listing compliance program. In addition, NASDAQ believes that such fees
are reasonable and that none of the proposed fees are unduly burdensome
or would discourage any company from pursuing an application or
submitting a plan of compliance, as applicable.
    The proposed changes are equitable and not unfairly discriminatory
because they would apply equally to all similarly situated companies.
In addition, aligning NASDAQ's fees with the costs incurred for
specific actions will help minimize the extent that companies that do
not utilize the application process, or which are compliant with all
listing standards, may subsidize the costs of review for other
companies. NASDAQ believes that excluding companies that submit a plan
for a board or committee deficiency

from the compliance plan review fee is not unfairly discriminatory
because these plans are generally simpler and require fewer resources
and less time to review.
    NASDAQ also believes that the proposed fees are consistent with the
investor protection objectives of Section 6(b)(5) of the Act \11\ in
that they are designed to promote just and equitable principles of
trade, to remove impediments to a free and open market and national
market systems, and in general to protect investors and the public
interest. Specifically, the fees are designed to ensure that there are
adequate resources for NASDAQ's listing compliance program, which helps
to assure that listing standards are properly enforced and investors
are protected.
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    \11\ 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. The market for
listing services is extremely competitive and listed companies may
freely choose alternative venues based on the aggregate fees assessed,
and the value provided by each listing. This rule proposal does not
burden competition with other listing venues, which are similarly free
to align their fees on the costs incurred by the process they offer.
For these reasons, NASDAQ does not believe that the proposed rule
change will result in any burden on competition for listings.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \12\ and paragraph (f) of Rule 19b-4
thereunder.\13\ 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.
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2013-130 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.

All submissions should refer to File Number SR-NASDAQ-2013-130. 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 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, 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; 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-2013-130 and should
be submitted on or before November 12, 2013

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-24636 Filed 10-21-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: April 17, 2008 (Volume 73, Number 75)]
[Notices]
[Page 21002-21003]
[DOCID:fr17ap08-109]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57658; File No. SR-NASDAQ-2008-030]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Modify the Charges for Pre-Trade Risk Management Workstation Add-Ons

April 11, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 7, 2008, The NASDAQ Stock Market LLC (``Nasdaq'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II and III below, which Items have
been prepared substantially by Nasdaq. Nasdaq has designated this
proposal as one establishing or changing a member due, fee, or other
charge imposed by Nasdaq under Section 19(b)(3)(A)(ii) of the Act \3\
and Rule 19b-4(f)(2) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq is proposing to adjust the recently-established member
charge for the use of PRM Workstation Add-ons. The text of the proposed
rule change is available at http://www.complinet.com/nasdaq, the
principal offices of the Exchange, and the Commission's Public
Reference Room.

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

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

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

1. Purpose
    Earlier this year, Nasdaq established the pricing for its new pre-
trade risk management (``PRM'') functionality.\5\ Included in the new
charges was the fee that PRM Module subscribers that are users of the
NASDAQ Workstation or WeblinkACT 2.0 would pay for PRM Workstation Add-
ons. At the time, it was envisioned that each subscriber would be able
to receive at no charge one PRM Workstation per PRM Module and would
pay $100 per month for each additional PRM Workstation per PRM Module.
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    \5\ See Securities Exchange Act Release No. 57146 (January 14,
2008), 73 FR 3786 (January 22, 2008) (SR-NASDAQ-2008-003).
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    Nasdaq has since determined that this approach is needlessly
cumbersome, costly to administer and potentially confusing to the
users. Therefore, Nasdaq has decided to make any needed number of PRM
Workstation Add-ons available to users at no charge during the months
of April through June 2008, and then, starting in July 2008, to begin
charging $100 per month for each PRM Workstation Add-on that users
request (thus eliminating the one-free-Add-on-per-module feature).
Nasdaq believes that the proposed change is minor, and therefore, the
PRM Workstation Add-on charges remain reasonable and equitably
allocated among members that may choose to use this functionality.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\6\ in general, and with Section
6(b)(4) of the Act,\7\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees and other charges among
members and issuers and other persons using any facility or system
which Nasdaq operates or controls. The pre-trade management risk
functionality provides members with an optional tool at a reasonable
cost. Members are not required to use the NASDAQ PRM or PRM Workstation
Add-ons. The optional nature of these services and the intensely
competitive environment in which they are being offered ensure that the
proposed charges will remain market-competitive.
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    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(4).
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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

    The foregoing proposed rule change has been designated as a fee
change pursuant to Section 19(b)(3)(A)(ii) of the Act \8\ and Rule 19b-
4(f)(2) \9\ thereunder, because it establishes or changes a due, fee,
or other charge imposed on members by Nasdaq. Accordingly, the proposal
is effective upon filing with the Commission. At any time within 60
days of the filing of the proposed rule change, the Commission may
summarily abrogate such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act.
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    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \9\ 17 CFR 240.19b-4(f)(2).
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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-2008-030 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2008-030. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use

only one method. The Commission will post all comments on the
Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for inspection and copying in the
Commission's Public Reference Room, 100 F Street, NE., Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of 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 publicly available. All submissions
should refer to File Number SR-NASDAQ-2008-030 and should be submitted
on or before May 8, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E8-8268 Filed 4-16-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 88, Number 187 (Thursday, September 28, 2023)]
[Notices]
[Pages 66932-66933]
[FR Doc No: 2023-21198]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2023-0043]

Qualification of Drivers; Exemption Applications; Implantable
Cardioverter Defibrillators (ICDs)

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of applications for exemption; request for comments.

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SUMMARY: FMCSA announces receipt of applications from two individuals
for an exemption from the prohibition in the Federal Motor Carrier
Safety Regulations (FMCSRs) against operation of a commercial motor
vehicle (CMV) by persons with a current clinical diagnosis of
myocardial infarction, angina pectoris, coronary insufficiency,
thrombosis, or any other cardiovascular disease of a variety known to
be accompanied by syncope (transient loss of consciousness), dyspnea
(shortness of breath), collapse, or congestive heart failure. If
granted, the exemptions would enable these individuals with ICDs to
operate CMVs in interstate commerce.

DATES: Comments must be received on or before October 30, 2023.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System Docket No. FMCSA-2023-0043 using any of the following
methods:
     Federal eRulemaking Portal: Go to www.regulations.gov/,
insert the docket number (FMCSA-2023-0043) in the keyword box and click
``Search.'' Next, choose the only notice listed, and click on the
``Comment'' button. Follow the online instructions for submitting
comments.
     Mail: Dockets Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, 1200 New Jersey
Avenue SE, Washington, DC, between 9 a.m. and 5 p.m. ET Monday through
Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room
W64-224, Washington, DC 20590-0001,<PHONE_NUMBER>,
[email protected]. Office hours are from 8:30 a.m. to 5 p.m. ET
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2023-0043), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so that FMCSA can contact you if there are questions
regarding your submission.
    To submit your comment online, go to https://www.regulations.gov/docket/FMCSA-2023-0043. Next, choose the only notice listed, click the
``Comment'' button, and type your comment into the text box on the
following screen. Choose whether you are submitting your comment as an
individual or on behalf of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number (FMCSA-2023-0043) in the keyword box and click ``Search.'' Next,
choose the only notice listed, and click ``Browse Comments.'' If you do
not have access to the internet, you may view the docket online by
visiting Dockets Operations on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between
9 a.m. and 5 p.m. ET Monday through Friday, except Federal holidays. To
be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

C. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption requests. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov. As described in the system of records
notice DOT/ALL 14 (Federal Docket Management System), which can be
reviewed at https://www.transportation.gov/

individuals/privacy/privacy-act-system-records-notices, the comments
are searchable by the name of the submitter.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statutes also allow the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The two individuals listed in this notice have requested an
exemption from Sec.  391.41(b)(4). Accordingly, the Agency will
evaluate the qualifications of each applicant to determine whether
granting the exemption will achieve the required level of safety
mandated by statute.
    The physical qualification standard found in Sec.  391.41(b)(4)
states that a person is physically qualified to drive a CMV if that
person has no current clinical diagnosis of myocardial infarction,
angina pectoris, coronary insufficiency, thrombosis, or any other
cardiovascular disease of a variety known to be accompanied by syncope,
dyspnea, collapse, or congestive cardiac failure.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. The advisory criteria states that ICDs are
disqualifying due to risk of syncope.
---------------------------------------------------------------------------

    \1\ These criteria may be found in 49 CFR part 391, Appendix A
to Part 391--Medical Advisory Criteria, Section D. Cardiovascular:
Sec.  391.41(b)(4), paragraph 4, which is available on the internet
at https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

III. Qualification of Applicant

Dean Cece

    Dean Cece is a class C driver's license holder in North Carolina.
In letters dated May 16, 2022, November 11, 2023, and February 15,
2023, Dean Cece's cardiology team reports that the ICD was implanted on
December 7, 1998. They state there have been no discharges from the ICD
and from a cardiac perspective, Dean Cece continues to be stable with
no limitation of physical activity, consistent with a New York Heart
Association class I rating.

Donald Roach

    Donald Roach is a class D driver's license holder in Kentucky. In a
letter dated May 12, 2023, Donald Roach's cardiologist reports that
their ICD was implanted on August 31, 2015. They state there have been
no discharges from the ICD and from a cardiac standpoint, Donald Roach
continues to be stable with no symptoms.

IV. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315(b), FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated under the DATES
section of the notice.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-21198 Filed 9-27-23; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 74, Number 110 (Wednesday, June 10, 2009)]
[Proposed Rules]
[Pages 27481-27484]
[FR Doc No: E9-13529]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-1262]
RIN 1625-AA00

Safety Zone; AVI September Fireworks Display; Laughlin, NV

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes a safety zone on the navigable waters
of the lower Colorado River, Laughlin, NV, in support of a fireworks
display near the AVI Resort and Casino. This safety zone is necessary
to provide for the safety of the participants, crew, spectators,
participating vessels, and other vessels and users of the waterway.
Persons and vessels are prohibited from entering into, transiting
through, or anchoring within this safety zone unless authorized by the
Captain of the Port, or his designated representative.

DATES: Comments and related material must be submitted on or before
July 10, 2009

ADDRESSES: You may submit comments identified by docket number USCG-
2008-1262 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
For instructions on submitting comments, see the ``Public Participation
and Request for Comments'' portion of the SUPPLEMENTARY INFORMATION
section below.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call Petty Officer Shane Jackson, USCG, Waterways Management,
U.S. Coast Guard Sector San Diego at<PHONE_NUMBER>. If you have
questions on viewing or submitting material to the docket, call Renee
V. Wright, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2008-1262), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail or hand
delivery, but please use only one of these means. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand delivery, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an e-mail address, or a phone number in the body of
your document so that we can contact you if we have questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov,
select the Advanced Docket Search option on the right side of the
screen, insert ``USCG-2008-1262'' in the Docket ID box, press Enter,
and then click on the balloon shape in the Actions column. If you
submit your comments by mail or hand delivery, submit them in an
unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We

will consider all comments and material received during the comment
period and may change the rule based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov
select the Advanced Docket Search option on the right side of the
screen, insert USCG-2008-1262 in the Docket ID box, press Enter, and
then click on the item in the Docket ID column. You may also visit
either the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays; or the U.S. Coast Guard
Sector San Diego, 2710 N. Harbor Drive, San Diego, CA 92101 between 8
a.m. and 2 p.m., Monday through Friday, except Federal holidays. We
have an agreement with the Department of Transportation to use the
Docket Management Facility.

Privacy Act

    Anyone can search the electronic form of all comments received into
any of our dockets by the name of the individual submitting the comment
(or signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008 issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one to the Docket Management Facility at the address under
ADDRESSES explaining why one would be beneficial using one of the four
methods specified under ADDRESSES. If we determine that one would aid
this rulemaking, we will hold one at a time and place announced by a
later notice in the Federal Register.

Background and Purpose

    The Coast Guard is establishing a temporary safety zone on the
navigable waters of the Lower Colorado River, Laughlin, NV in support
of a fireworks show in the navigational channel of the Lower Colorado
River, Laughlin, NV. The fireworks show is being sponsored by the AVI
Resort and Casino. The safety zone is set at a 1,000 foot radius around
the anchored firing barge. This temporary safety zone is necessary to
provide for the safety of the show's crew, spectators, participants of
the event, participating vessels, and other vessels and users of the
waterway.

Discussion of Proposed Rule

    The Coast Guard proposes a safety zone that would be enforced from
8 p.m. to 9:45 p.m. on September 6, 2009. The limits of the safety zone
is to include all navigable waters within 1,000 feet of the firing
location adjacent to the AVI Resort and Casino centered in the channel
between Laughlin Bridge and the northwest point of AVI Resort and
Casino Cove in position: 35[deg]00'45'' N, 114[deg]38'16'' W.
    This safety zone is necessary to provide for the safety of the
crews, spectators, and participants of the event and to protect other
vessels and users of the waterway. Persons and vessels will be
prohibited from entering into, transiting through, or anchoring within
this safety zone unless authorized by the Captain of the Port, or his
designated representative.
    U.S. Coast Guard personnel would enforce this safety zone. Other
Federal, State, or local agencies may assist the Coast Guard, including
the Coast Guard Auxiliary. Vessels or persons violating this rule would
be subject to both criminal and civil penalties.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order. Although the safety zone
will restrict boating traffic within the navigable waters of the Lower
Colorado River, Laughlin, NV, the effect of this regulation will not be
significant as the safety zone will encompass only a small portion of
the waterway and will be very short in duration. The entities most
likely to be affected are pleasure craft engaged in recreational
activities and sightseeing. As such, the Coast Guard expects the
economic impact of this rule to be minimal.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. 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.
    This proposed rule would affect the following entities, some of
which might be small entities: the owners or operators of vessels
intending to transit or anchor in the region of the lower Colorado
River adjacent to AVI Resort and Casino from 8 p.m. to 9:45 p.m. on
September 6, 2009.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons. The
safety zone only encompasses a small portion of the waterway, it is
short in duration at a relatively late hour when commercial traffic is
low, and the Captain of the Port may authorize entry into the zone, if
necessary. Before the effective period, the Coast Guard will publish a
local notice to mariners (LNM) and will issue broadcast notice to
mariners (BNM) alerts via marine channel 16 VFH before the safety zone
is enforced.
    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.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact Petty Officer Shane Jackson,
USCG, Waterways Management, U.S. Coast Guard Sector San Diego at (619)
278-7267. The Coast Guard will not retaliate against small entities
that question or complain about this rule or any policy or action of
the Coast Guard.

Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

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 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.

Taking of Private Property

    This proposed rule would not effect a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    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.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions which do not individually or cumulatively have a
significant effect on the human environment. A preliminary
environmental analysis checklist supporting this preliminary
determination is available in the docket where indicated under
ADDRESSES. This proposed rule involves a safety zone. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this proposed rule.

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 proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 122, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Public Law 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

    2. A new temporary safety zone Sec.  165.T11-166

Sec.  165.T11-166 AVI  September Fireworks Display; Laughlin, Nevada.

    (a) Location. The limits of the proposed safety zone are as
follows: is to include all navigable waters within 1000 feet of the
firing location adjacent to the AVI Resort and Casino centered in the
channel between Laughlin Bridge and the northwest point of AVI Resort
and Casino Cove in position: 35[deg]00'45'' N, 114[deg]38'16'' W.
    (b) Enforcement Period. This section will be enforced from 8 p.m.
to 9:45 p.m. on September 6, 2009. If the event concludes prior to the
scheduled termination time, the Captain of the Port will cease
enforcement of this safety zone and will announce that fact via
Broadcast Notice to Mariners.
    (c) Definitions. The following definition applies to this section:
designated representative, means any commissioned, warrant, and petty
officers of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, state, and federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated on-scene representative.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from the Patrol Commander
(PATCOM). The PATCOM may be contacted on VHF-FM Channel 16.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or the designated representative.

    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, flashing light, or other means, the operator of a vessel
shall proceed as directed.
    (5) The Coast Guard may be assisted by other federal, state, or
local agencies.

    Dated: May 5, 2009.
T.H. Farris,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. E9-13529 Filed 6-9-09; 8:45 am]
BILLING CODE 4910-15-P


[Federal Register Volume 83, Number 100 (Wednesday, May 23, 2018)]
[Rules and Regulations]
[Pages 23819-23825]
[FR Doc No: 2018-10693]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0035; FRL-9977-13]

Clopyralid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
clopyralid in or on multiple commodities which are identified and
discussed later in this document. In addition, it removes certain
previously established tolerances that are superseded by this final
rule. Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 23, 2018. Objections and
requests for hearings must be received on or before July 23, 2018, 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-2017-0035, 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), 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 Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), 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 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-2017-0035 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
July 23, 2018. 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-2017-0035, 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.html.
    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 June 8, 2017 (82 FR 26641) (FRL-9961-
14), 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
6E8528) by IR-4 Project Headquarters, 500 College Road East, Suite
201W, Princeton, New Jersey 08540. The petition requested that 40 CFR
part 180 be amended by establishing tolerances for residues of the
herbicide, clopyralid, (3,6-dichloro-2-pyridinecarboxylic acid), in or
on berry, low growing, subgroup 13-07G at 4.0 parts per million (ppm);
berry, low growing, except strawberry, subgroup 13-07H at 4.0 ppm;
brassica, leafy greens, subgroup 4-16B at 5.0 ppm; fruit, pome, group
11-10 at 0.05 ppm; fruit, stone, group 12-12 at 0.5 ppm; radish, roots
at 0.3 ppm; stalk and stem vegetable subgroup 22A at 1.0 ppm;
vegetable, brassica, head and stem, group 5-16 at 2.0 ppm; and
vegetable, leaves of root and tuber, group 2 at 5.0 ppm. Additionally,
upon establishment of the above new tolerances, the petitioner requests
to amend 40 CFR 180.431 by removing the established tolerances for
clopyralid in or on apple at 0.05 ppm, asparagus at 1.0 ppm, beet,
garden, tops at 3.0 ppm, beet, sugar, tops at 3.0 ppm, brassica, head
and stem, subgroup 5A at 2.0 ppm, brassica, leafy greens, subgroup 5B
at 5.0 ppm, canola, seed at 3.0 ppm, cranberry at 4.0 ppm, fruit,
stone, group 12 at 0.5 ppm, strawberry at 4.0 ppm, and turnip, greens
at 4.0 ppm. That document referenced a summary of the petition prepared
by Dow AgroSciences, the registrant, which is available in the docket,
http://www.regulations.gov. One comment was received on the notice of
filing. EPA's response to that comment is discussed in Unit IV.C.
    Consistent with the authority in FFDCA 408(d)(4)(A)(i), EPA is
issuing tolerances that vary from what the petitioner sought. The
reasons for these changes are explained in Unit IV.D.

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 clopyralid including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with clopyralid follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
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.
    Clopyralid has low acute toxicity via the dermal, oral, and
inhalation routes of exposure. It is not a dermal irritant or
sensitizer, but it is a severe eye irritant in its acid form.
    Toxicity was observed in the mouse after subchronic and chronic
exposure and the rat and dog after chronic exposure, but consistent
target organs were not identified. In dogs, reductions in red blood
cell parameters, increased liver weight, and vacuolated adrenal
cortical cells were observed, with skin lesions and clinical chemistry
changes at the highest dose. In rats, stomach lesions were observed at
the lowest-observed-adverse-effects level (LOAEL), and decreased body
weight was observed at the high dose. In mice, the only observed
effects were decreased body weight/body weight gain. No systemic
toxicity was seen in a rabbit 21-day dermal toxicity study. The
available toxicology studies did not indicate the potential for
neurotoxicity, immunotoxicity or reproductive toxicity.
    The available database does not show evidence of increased
qualitative or quantitative pre- and/or post-natal susceptibility in
the available developmental or 2-generation reproduction toxicity
studies. No developmental toxicity was observed in the rat at doses
that caused maternal mortality. In the developmental study in the
rabbit, decreased fetal body weight and hydrocephalus were observed,
but only at a dose that caused significant maternal toxicity, including
mortality, clinical signs of toxicity, and gastric mucosal lesions.
Reproductive toxicity was not observed in the rat, but mean pup weights
(day 28) were reduced, and relative pup liver weights were increased at
doses that caused parental toxicity (decreased body weight/weight gain
and food consumption; gastric lesions).
    There were no direct clinical or histopathological indications of
neurotoxicity in the available studies at doses up to or exceeding the
limit dose. Hydrocephalus was observed in the young in the rabbit
developmental study, but only in the presence of significant maternal
toxicity, including a high rate of mortality.
    Clopyralid is classified as ``not likely to be carcinogenic to
humans,'' based on the lack of treatment-related tumors in the rat and
mouse carcinogenicity studies, and negative results of the genotoxicity
assays.
    Specific information on the studies received and the nature of the
adverse effects caused by clopyralid as well as the no-observed-
adverse-effect-level (NOAEL) and LOAEL from the toxicity studies can be
found at http://www.regulations.gov in document SUBJECT: Clopyralid.
Aggregate Human Health Risk Assessment to Support Proposed New Uses on
Pome Fruit Group 11-10 and Radish Roots, Along with Various Crop Group/
Subgroup Conversions and Expansions at pages 31-35 in docket ID number
EPA-HQ-OPP-2017-0035.

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 the NOAEL and the LOAEL are identified.
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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for clopyralid used for
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Clopyralid for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)      NOAEL= 15 mg/kg/day      Chronic RfD = 0.15 mg/   2-Year Combined Chronic
                                       UFA = 10x..............   kg/day.                  Toxicity-
                                       UFH = 10x..............  cPAD = 0.15 mg/kg/day..   Carcinogenicity
                                       FQPA SF = 1x...........                            (oral)--rat.
                                                                                LOAEL = 150 mg/kg/day,
                                                                                based on increased
                                                                                epithelial hyperplasia
                                                                                and thickening of the
                                                                                limiting ridge of the
                                                                                stomach in both sexes.
Incidental oral short-term (1 to 30    NOAEL= 75 mg/kg/day....  Residential LOC for MOE  Developmental Toxicity
 days).                                UFA = 10x..............   = <100.                  (oral)--rat.
                                       UFH = 10x..............                           Maternal LOAEL = 250 mg/
                                       FQPA SF = 1x...........                            kg/day, based on
                                                                                mortality.

Inhalation short-term (1 to 30 days).  Inhalation (or oral)     Residential LOC for MOE  Developmental Toxicity
                                        study NOAEL = 75 mg/kg/  = <100.                  (oral)--rat.
                                        day (inhalation                                  Maternal LOAEL = 250 mg/
                                        absorption rate =                                 kg/day, based on
                                        100%).                                            mortality.
                                       UFA = 10x..............
                                       UFH = 10x..............
                                       FQPA SF = 1x...........
                                      --------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)                     ``Not likely to be carcinogenic to humans.''
 routes.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to clopyralid, EPA considered exposure under the petitioned-
for tolerances as well as all existing clopyralid tolerances in 40 CFR
180.431. EPA assessed dietary exposures from clopyralid 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.
    No such effects were identified in the toxicological studies for
clopyralid; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID) which incorporates
consumption data from the United States Department of Agriculture's
(USDA) National Health and Nutrition Examination Survey, What We Eat in
America, (NHANES/WWEIA) conducted from 2003 to 2008. As to residue
levels in food, the chronic dietary exposure assessment was based on
tolerance-level residues, and assumed that 100 percent (PCT) of all
crops were treated.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that clopyralid does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for clopyralid. Tolerance level residues and 100 PCT were 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 clopyralid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of clopyralid. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Water Calculator Version 1.52 (PWC) model,
the estimated drinking water concentrations (EDWCs) of clopyralid for
chronic exposures for non-cancer assessments are estimated to be 5.43
parts per billion (ppb) for surface water and 38.1 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 38.1 ppb was used to
assess the contribution from 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).
    Clopyralid is currently registered for the following uses that
could result in residential exposures: Weed control on lawns, turf and
ornamentals in residential and public areas. EPA assessed residential
exposure using the following assumptions: Residential handler exposures
are not expected since the residential uses require that handlers wear
specific clothing (e.g., long-sleeved shirt and long pants; shoes plus
socks) and/or personal protective equipment (e.g., gloves). As a
result, a residential handler assessment was not conducted. Short-term
post-application exposure is anticipated for children from incidental
oral contact with treated turf (hand-to-mouth, object-to-mouth and soil
ingestion). Post-application dermal exposure is also anticipated from
residential use of clopyralid. However, systemic toxicity via the
dermal route of exposure is not expected for clopyralid. Therefore,
dermal risks were not quantitatively assessed for residential exposure.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-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.''
    EPA has not found clopyralid to share a common mechanism of
toxicity with any other substances, and clopyralid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
clopyralid does not have a common mechanism of toxicity with other
substances.

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. There was no evidence of
increased qualitative or quantitative sensitivity/susceptibility in the
developing or young animal. In the rat developmental toxicity study, no
developmental toxicity was observed at a maternally toxic dose. In the
rat 2-generation reproductive toxicity study, decreased pup weight
(post-natal day 28), and increased relative liver weights were observed
at the parental LOAEL. Hydrocephalus and decreased mean fetal weight
were observed in the rabbit developmental study, but at a dose that
also caused significant maternal toxicity, including mortality;
therefore, quantitative or qualitative developmental susceptibility was
not observed for clopyralid.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
Food Quality Protection Act Safety Factor Safety Factor (FQPA SF) were
reduced to 1X. That decision is based on the following findings:
    i. The toxicity database for clopyralid is considered complete and
no additional studies are required at this time.
    ii. There are no clinical or micropathological indications of
neurotoxicity in the available subchronic and chronic studies in
multiple species. Hydrocephalus was observed in fetuses in the rabbit
developmental study, but only at a high dose that resulted in
significant maternal toxicity, including mortality. There is no need
for a developmental neurotoxicity study or additional uncertainty
factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that clopyralid results in increased
susceptibility in utero in 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 dietary
and residential exposure databases. EPA conducted the chronic dietary
food exposure assessment based on 100 PCT, tolerance-level residues of
clopyralid, and default processing factors, where applicable. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to clopyralid in drinking water. EPA
used similarly conservative assumptions to assess post-application
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by clopyralid.

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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
clopyralid is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
clopyralid from food and water will utilize 26% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
clopyralid is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Several
clopyralid products are currently registered for uses that could result
in short-term residential exposure and the Agency has determined that
it is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to clopyralid.
    Using the exposure assumptions described in this unit for short-
term exposures and data results from a most recent previous EPA
assessment of residential exposure, the Agency combined food, water,
and short-term residential exposures result in aggregate MOEs of 1600
for children. Because EPA's level of concern (LOC) for clopyralid is an
MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
clopyralid is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk
aggregate risk is assessed based on intermediate- term residential
exposure plus chronic dietary exposure. Because there is no
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 intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for clopyralid.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, clopyralid is not expected to pose a cancer risk to humans.
    6. 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 clopyralid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The Pesticide Analytical Manual Volume II (PAM II) lists a method
utilizing gas chromatography with electron capture detection (GC/ECD)
for determination of clopyralid residues in plant commodities (Method I
or Method ACR 75.6).
    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 protected].

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 clopyralid residues on any
commodities for which tolerances are established in this rule.

C. Response to Comments

    One comment to the Notice of Filing was received from an anonymous
commenter that stated, in part, that no clopyralid (pesticide) residue
should be allowed on food crops.
    EPA's Response: The Agency recognizes that some individuals believe
that pesticides should not be allowed on agricultural crops. However,
the existing legal framework provided by section 408 of the Federal
Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set
when persons seeking such tolerances or exemptions have demonstrated
that the pesticide meets the safety standard imposed by that statute.
This commenter's statements appear to be directed at the underlying
statute and not EPA's implementation of it; the commenter has made no
contention that EPA has acted in violation of the statutory framework.

D. Revisions to Petitioned-For Tolerances

    EPA is establishing individual tolerances in kohlrabi and broccoli,
chinese as they were part of subgroup 5A, but not included in expansion
crop group 5-16 for which a tolerance is being established by this
action.
    EPA is not establishing the petitioned-for tolerance for Berry, low
growing, except strawberry, subgroup 13-07H because it is not
necessary. All commodities in subgroup 13-07H, plus strawberry, are
included in subgroup 13-07G.
    In accordance with its standard practice to provide greater
precision about the levels of residues that are permitted by a
tolerance, EPA is adding an additional significant figure to the
petitioned-for tolerance values for the following commodities: Fruit,
stone, group 12-12 from 0.5 to 0.50 ppm and radish, roots from 0.3 to
0.30. This is to avoid the situation where residues may be higher than
the tolerance level, but as a result of rounding would be considered
non-violative (for example, radish, roots proposed at 0.3 ppm was
established at 0.30 ppm, to avoid an observed hypothetical tolerance at
0.34 ppm being rounded to 0.3 ppm).

V. Conclusion

    Therefore, tolerances are established for residues of clopyralid,
(3,6-dichloro-2-pyridinecarboxylic acid), in or on Berry, low growing,
subgroup 13-07G at 4.0 ppm; Brassica, leafy greens, subgroup 4-16B at
5.0 ppm; broccoli, Chinese at 2.0 ppm; fruit, pome, group 11-10 at 0.05
ppm; fruit, stone, group 12-12 at 0.50 ppm; kohlrabi at 2.0 ppm;
radish, roots at 0.30 ppm; stalk and stem vegetable subgroup 22A at 1.0
ppm; vegetable, Brassica, head and stem, group 5-16 at 2.0 ppm; and
vegetable, leaves of root and tuber, group 2 at 5.0 ppm. In addition,
established tolerances in or on ``apple''; ``asparagus''; ``beet,
garden, tops''; ``beet, sugar, tops''; ``Brassica, head and stem,
subgroup 5A''; ``Brassica, leafy greens, subgroup 5B''; ``canola,
seed''; ``cranberry''; ``fruit, stone, group 12''; ``strawberry''; and
``turnip, greens'' are removed as they are superseded by this final
tolerance rule.

VI. Statutory and Executive Order Reviews

    This action 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 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); Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). 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: April 30, 2018.
Daniel Rosenblatt,
Acting 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. Amend the table in Sec.  180.431(a) as follows:
0
a. Add alphabetically the entries for ``Berry, low growing, subgroup
13-07G'';``Brassica, leafy greens, subgroup 4-16B''; ``Broccoli,
Chinese''; ``Fruit, pome, group 11-10''; ``Fruit, stone, group 12-12'';
``Kohlrabi''; ``Radish, roots''; ``Stalk and stem vegetable subgroup
22A''; ``Vegetable, Brassica, head and stem, group 5-16''; and
``Vegetable, leaves of root and tuber, group 2''.
0
b. Remove the entries for ``Apple''; ``Asparagus''; ``Beet, garden,
tops''; ``Beet, sugar, tops''; ``Brassica, head and stem, subgroup
5A''; ``Brassica, leafy greens, subgroup 5B''; ``Canola, seed'';
``Cranberry''; ``Fruit, stone, group 12''; ``Strawberry''; and
``Turnip, greens''.
    The additions read as follows:

Sec.  180.431  Clopyralid; Tolerances for residues.

    (a) * * *

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

                                * * * * *
Berry, low growing, subgroup 13-07G.........................         4.0
Brassica, leafy greens, subgroup 4-16B......................         5.0

                                * * * * *
Broccoli, Chinese...........................................         2.0

                                * * * * *
Fruit, pome, group 11-10....................................        0.05
Fruit, stone, group 12-12...................................        0.50

                                * * * * *
Kohlrabi....................................................         2.0

                                * * * * *
Radish, roots...............................................        0.30

                                * * * * *
Stalk and stem vegetable subgroup 22A.......................         1.0

                                * * * * *
Vegetable, Brassica, head and stem, group 5-16..............         2.0
Vegetable, leaves of root and tuber, group 2................         5.0

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

* * * * *
[FR Doc. 2018-10693 Filed 5-22-18; 8:45 am]
 BILLING CODE 6560-50-P