[Federal Register Volume 76, Number 213 (Thursday, November 3, 2011)]
[Notices]
[Pages 68240-68242]
[FR Doc No: 2011-28512]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65656; File No. SR-FINRA-2011-062]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Proposed Rule Change To Repeal
Incorporated NYSE Rule 2A (Jurisdiction)

October 28, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'' or ``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on October 20, 2011, Financial Industry Regulatory
Authority, Inc. (``FINRA'') 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 FINRA. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to repeal Incorporated NYSE Rule 2A
(Jurisdiction) as part of the process of developing a consolidated
FINRA rulebook.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA 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, FINRA 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. FINRA 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
    As part of the process of developing a new consolidated rulebook
(``Consolidated FINRA Rulebook''),\3\ the proposed rule change would
repeal NYSE Rule 2A (Jurisdiction) from the FINRA rulebook as described
below. NYSE Rule 2A generally addresses jurisdictional authority with
respect to, among other things, rulemaking, examinations, disciplinary
actions, and listing applications. NYSE Rule 2A was adopted in 2006 as
part of the merger between the New York Stock Exchange LLC (``NYSE'')
and Archipelago Holdings, Inc. in light of the fact that the NYSE
Constitution, which contained the jurisdiction provisions for the NYSE,
was eliminated in the merger.\4\
---------------------------------------------------------------------------

    \3\ The current FINRA rulebook consists of (1) FINRA Rules; (2)
NASD Rules; and (3) rules incorporated from NYSE (``Incorporated
NYSE Rules'') (together, the NASD Rules and Incorporated NYSE Rules
are referred to as the ``Transitional Rulebook''). While the NASD
Rules generally apply to all FINRA members, the Incorporated NYSE
Rules apply only to those members of FINRA that are also members of
the NYSE (``Dual Members''). The FINRA Rules apply to all FINRA
members, unless such rules have a more limited application by their
terms. For more information about the rulebook consolidation
process, see Information Notice, March 12, 2008 (Rulebook
Consolidation Process). For convenience, the Incorporated NYSE Rules
are referred to as the NYSE Rules.
    \4\ See Securities Exchange Act Release No. 53382 (February 27,
2006), 71 FR 11251 (March 6, 2006) (Order Approving File No. SR-
NYSE-2005-77).
---------------------------------------------------------------------------

    The FINRA By-Laws, as approved by the membership and the SEC in
2007, address the powers and authority of the FINRA Board of Governors
(``Board'') and, together with the Exchange Act, set forth FINRA's
authority and responsibilities as a registered securities association.
As outlined below, those matters addressed by NYSE Rule 2A that are
relevant to a registered securities association are currently addressed
by the FINRA By-Laws and Exchange Act, including jurisdictional
authority with respect to:
     Rulemaking; \5\
---------------------------------------------------------------------------

    \5\ See, e.g., FINRA By-Laws, Article III, Section 2, Article
VII, Section 1 and Exchange Act Section 15A.
---------------------------------------------------------------------------

     General supervisory powers over members, member
organizations (and any other broker-dealer that chooses to be regulated
by the NYSE) and their offices, partnership and corporate arrangements,
their principal executives, employees and approved persons in
connection with their conduct of the business of member organizations;
\6\
---------------------------------------------------------------------------

    \6\ See, e.g., supra note 5 and FINRA By-Laws, Article VI,
Section 5 and Plan of Allocation and Delegation of Functions by
FINRA to Subsidiaries, Article II, Section A. In contrast to the
NYSE's jurisdictional provisions, which extend to ``approved
persons,'' as defined in NYSE Rule 2(c), FINRA regulates its members
and ``persons associated with a member,'' as defined in FINRA By-
Laws, Article 1 (rr). With respect to the ability to obtain
information regarding members' affiliates, FINRA is addressing such
authority as part of a separate proposal. See Regulatory Notice 10-
01 (January 2010).
---------------------------------------------------------------------------

     jurisdiction to discipline members, member organizations
(and any other broker-dealer that chooses to be regulated by the NYSE),
principal executives, employees and approved persons in connection with
their conduct of the business of member organizations; and \7\
---------------------------------------------------------------------------

    \7\ See, e.g., supra note 5, and FINRA By-Laws, Article VI,
Section 5 and Plan of Allocation and Delegation of Functions by
FINRA to Subsidiaries, Article II, Section A. Based on earlier Board
authority, FINRA repealed NYSE Rule 477 (Retention of Jurisdiction)
and continues to use FINRA's retention of jurisdiction provisions in
the FINRA By-laws. See Securities Exchange Act Release No. 58643
(September 25, 2008), 73 FR 57174 (October 1, 2008) (Order Approving
File No. SR-FINRA-2008-029).
---------------------------------------------------------------------------

     Jurisdiction over any and all other functions of members,
member organizations (and any other broker-dealer that chooses to be
regulated by the NYSE), principal executives, employees and approved
persons in connection with the conduct of the business of member
organizations in order for the NYSE to comply with its statutory
obligation as a self-regulatory organization.\8\
---------------------------------------------------------------------------

    \8\ See, e.g., supra note 5, and FINRA By-Laws, Article VI,
Section 5 and Plan of Allocation and Delegation of Functions by
FINRA to Subsidiaries, Article II, Section A.
---------------------------------------------------------------------------

    FINRA further notes that other matters addressed by NYSE Rule 2A
are not applicable to the operations of a registered securities
association that does not operate a listing market or are otherwise
unique to the NYSE, including:
     Approving applications for the listing and admission of
securities to dealings on the NYSE, as well as suspending dealings in
and removing securities from listing;
     Supervising all matters relating to the collection,
dissemination and use of quotations and of reports of prices on the
NYSE;
     The power to approve or disapprove any connection or means
of communication with the floor and requiring the discontinuance of any
such connection or means of communication; and
     Disapproving any member acting as a Designated Market
Maker or odd-lot dealer on the NYSE.
    Therefore, FINRA considers the transfer of NYSE Rule 2A to the
Consolidated FINRA Rulebook to be unnecessary and proposes that it be
eliminated.\9\
---------------------------------------------------------------------------

    \9\ FINRA anticipates that the NYSE will retain a version of
NYSE Rule 2A.
---------------------------------------------------------------------------

    FINRA will announce the implementation date of the proposed rule
change in a Regulatory Notice to be published no later than 90 days
following Commission approval. The effective date will be no later than
150 days following Commission approval.
 2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\10\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change will
streamline and improve FINRA's rulebook by eliminating a rule that is
not necessary or appropriate for the Consolidated FINRA Rulebook. As
further discussed above, the FINRA By-Laws address the powers and
authority of the Board and, together with the Exchange Act, set forth
FINRA's authority and responsibilities as a registered securities
association.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

    FINRA 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.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) As the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory

organization consents, the Commission will:
    (A) by order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2011-062 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2011-062. 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
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. 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-FINRA-2011-062 and should be
submitted on or before November 25, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-28512 Filed 11-2-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 144 (Monday, July 27, 2020)]
[Rules and Regulations]
[Pages 45107-45109]
[FR Doc No: 2020-16248]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-SFUND-2005-0011; FRL-10012-63-Region 5]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Deletion of the Scrap Processing Co., Inc.
Superfund Site

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) Region 5 is
publishing a direct final Notification of Deletion of the Scrap
Processing Co., Inc. Superfund Site (Scrap Processing Site or Site),
located in Medford, Wisconsin, from the National Priorities List (NPL).
The NPL, promulgated pursuant to Section 105 of the Comprehensive
Environmental Response, Compensation, and Liability Act (CERCLA) of
1980, as amended, is an appendix of the National Oil and Hazardous
Substances Pollution Contingency Plan (NCP). This direct final deletion
is being published by EPA with the concurrence of the State of
Wisconsin, through the Wisconsin Department of Natural Resources (WDNR)
because EPA has determined that all appropriate response actions under
CERCLA, other than operation and maintenance, monitoring institutional
controls, and five-year reviews, have been completed. However, this
deletion does not preclude future actions under Superfund.

DATES: This direct final deletion is effective September 25, 2020
unless EPA receives adverse comments by August 26, 2020. If adverse
comments are received, EPA will publish a timely withdrawal of the
direct final deletion in the Federal Register informing the public that
the deletion will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
SFUND-2005-0011, by one of the following methods:
     https://www.regulations.gov. Follow the on-line
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any

information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
     Email<EMAIL_ADDRESS>    Written comments submitted by mail are temporarily suspended and no
hand deliveries will be accepted. We encourage the public to submit
comments via email or at https://www.regulations.gov.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-SFUND-
2005-0011. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through https://www.regulations.gov or email. The https://www.regulations.gov website
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through https://www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the https://www.regulations.gov index, Docket ID No. EPA-HQ-SFUND-2005-0011.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available electronically at https://www.regulations.gov and at https://www.epa.gov/superfund/scrap-processing or you may contact the person identified in the FOR FURTHER
INFORMATION CONTACT section for additional availability information.
    The EPA is temporarily suspending its Docket Center and Regional
Records Centers for public visitors to reduce the risk of transmitting
COVID-19. In addition, many site information repositories are closed
and information in these repositories, including the deletion docket,
has not been updated with hardcopy or electronic media. For further
information and updates on EPA Docket Center services, please visit us
online at https://www.epa.gov/dockets.
    The EPA continues to carefully and continuously monitor information
from the Centers for Disease Control and Prevention (CDC), local area
health departments, and our Federal partners so that we can respond
rapidly as conditions change regarding COVID-19.

FOR FURTHER INFORMATION CONTACT: Karen Cibulskis, NPL Deletion
Coordinator, U.S. Environmental Protection Agency Region 5, at (312)
886-1843 or via email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. NPL Deletion Criteria
III. Deletion Procedures
IV. Basis for Site Deletion
V. Deletion Action

I. Introduction

    EPA Region 5 is publishing this direct final Notification of
Deletion of the Scrap Processing Site from the NPL. The NPL constitutes
Appendix B of 40 CFR part 300, which is the NCP, which EPA promulgated
pursuant to Section 105 of CERCLA of 1980, as amended. EPA maintains
the NPL as the list of sites that appear to present a significant risk
to public health, welfare, or the environment. Sites on the NPL may be
the subject of remedial actions financed by the Hazardous Substance
Superfund (Fund). As described in 40 CFR 300.425(e)(3) of the NCP,
sites deleted from the NPL remain eligible for Fund-financed remedial
actions if future conditions warrant such actions.
    Section II of this preamble explains the criteria for deleting
sites from the NPL. Section III of this preamble discusses the
procedures that EPA is using for this action. Section IV of this
preamble discusses where to access and review information that
demonstrates how the deletion criteria have been met at the Scrap
Processing Site. Section V of this preamble discusses EPA's action to
delete the Scrap Processing Site from the NPL unless adverse comments
are received during the public comment period.

II. NPL Deletion Criteria

    The NCP establishes the criteria that EPA uses to delete sites from
the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted
from the NPL where no further response is appropriate. In making such a
determination pursuant to 40 CFR 300.425(e), EPA will consider, in
consultation with the State, whether any of the following criteria have
been met:
    i. Responsible parties or other persons have implemented all
appropriate response actions required;
    ii. All appropriate Fund-financed response under CERCLA has been
implemented, and no further response action by responsible parties is
appropriate; or
    iii. The remedial investigation has shown that the release poses no
significant threat to public health or the environment and, therefore,
the taking of remedial measures is not appropriate.
    Pursuant to CERCLA Section 121(c) and the NCP, EPA conducts five-
year reviews to ensure the continued protectiveness of remedial actions
where hazardous substances, pollutants, or contaminants remain at a
site above levels that allow for unlimited use and unrestricted
exposure. EPA conducts such five-year reviews even if a site is deleted
from the NPL. EPA may initiate further action to ensure continued
protectiveness at a deleted site if new information becomes available
that indicates it is appropriate. Whenever there is a significant
release from a site deleted from the NPL, the deleted site may be
restored to the NPL without application of the hazard ranking system.

III. Deletion Procedures

    The following procedures apply to deletion of the Scrap Processing
Site:
    (1) EPA consulted with the State of Wisconsin prior to developing
this

direct final Notification of Deletion and the Notification of Intent to
Delete co-published today in the ``Proposed Rules'' section of the
Federal Register.
    (2) EPA has provided the State thirty (30) working days for review
of this action and the parallel Notification of Intent to Delete prior
to their publication today, and the State, through the WDNR, concurred
with the deletion of the Scrap Processing Site from the NPL on July 16,
2020.
    (3) Concurrently with the publication of this direct final
Notification of Deletion, an announcement of the availability of the
parallel Notification of Intent to Delete is being published in a major
local newspaper, The Star News. The newspaper advertisement announces
the 30-day public comment period concerning the Notification of Intent
to Delete the Scrap Processing Site from the NPL.
    (4) EPA placed copies of documents supporting the proposed deletion
in the deletion docket and made these items available for public
inspection and copying at https://www.regulations.gov, Docket ID No.
EPA-HQ-SFUND-2005-0011 and at https://www.epa.gov/superfund/scrap-processing.
    If adverse comments are received within the 30-day public comment
period on this deletion action, EPA will publish a timely notice of
withdrawal of this direct final Notification of Deletion in the Federal
Register before its effective date and will prepare a response to
comments and continue with the deletion process on the basis of the
Notification of Intent to Delete and the comments already received.
    Deletion of a site from the NPL does not itself create, alter, or
revoke any individual's rights or obligations. Deletion of a site from
the NPL does not in any way alter EPA's right to take enforcement
actions, as appropriate. The NPL is designed primarily for
informational purposes and to assist EPA management. Section
300.425(e)(3) of the NCP states that the deletion of a site from the
NPL does not preclude eligibility for future response actions, should
future conditions warrant such actions.

IV. Basis for Site Deletion

    The EPA placed a copy of its Final Close Out Report for the Site
and other documents supporting the proposed deletion in the deletion
docket. The material provides the explanation of EPA's rationale for
the deletion and demonstrates how it meets the deletion criteria. This
information is made available for public inspection in the deletion
docket available at https://www.regulations.gov, Docket ID No. EPA-HQ-
SFUND-2005-0011 and at https://www.epa.gov/superfund/scrap-processing.

V. Deletion Action

    EPA, with concurrence of the State of Wisconsin, through the WDNR,
has determined that all appropriate response actions under CERCLA,
other than operation and maintenance, monitoring institutional
controls, and five-year reviews have been completed at the Scrap
Processing Site. Therefore, EPA is deleting the Scrap Processing Site
from the NPL.
    Because EPA considers this action to be noncontroversial and
routine, EPA is taking it without prior publication. This action will
be effective September 25, 2020 unless EPA receives adverse comments by
August 26, 2020. If adverse comments are received within the 30-day
public comment period, EPA will publish a timely withdrawal of this
direct final Notification of Deletion before its effective date and the
deletion will not take effect. EPA will prepare a response to comments
and continue with the deletion process on the basis of the Notification
of Intent to Delete and the comments already received. There will be no
additional opportunity to comment.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Dated: July 22, 2020.
Kurt Thiede,
Regional Administrator, Region 5.

    For the reasons set out in this document, 40 CFR part 300 is
amended as follows:

PART 300--NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION
CONTINGENCY PLAN

0
1. The authority citation for part 300 continues to read as follows:

    Authority: 33 U.S.C. 1251 et seq.

Appendix B to Part 300--[Amended]

0
2. Table 1 of Appendix B to part 300 is amended by removing the entry
``WI,'' ``Scrap Processing Co., Inc.'', ``Medford''.

[FR Doc. 2020-16248 Filed 7-24-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 18, 2008 (Volume 73, Number 76)]
[Rules and Regulations]
[Page 21043-21049]
[DOCID:fr18ap08-8]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0139; FRL-8359-9]

Thiamethoxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for combined residues
of the insecticide thiamethoxam and its metabolite, CGA-322704, in or
on soybean, hulls and soybean, aspirated grain fractions. Syngenta Crop
Protection, Inc. requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 18, 2008. Objections and
requests for hearings must be received on or before June 17, 2008, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0139. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

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

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or

pesticide manufacturer. Potentially affected entities may include, but
are not limited to those engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2008-0139 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before June 17, 2008.
    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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0139, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of March 12, 2008 (73 FR 13225) (FRL-8354-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F7301) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro,
NC 27419-8300. The petition requested that 40 CFR 180.565 be amended by
establishing a tolerance for combined residues of the insecticide
thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine, and its metabolite, CGA-322704,N-(2-
chloro-thiazol-5-ylmethyl) -N'-methyl-N'-nitro-guanidine, in or on
soybean, hulls at 2.0 ppm and soybean, aspirated grain fractions at
0.08 ppm. That notice referenced a summary of the petition prepared by
Syngenta Crop Protection, Inc., the registrant, which is available to
the public in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.

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 section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for
tolerances for combined residues of the insecticide thiamethoxam, 3-
[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-
oxadiazin-4-imine, and its metabolite, CGA-322704, N-(2-chloro-thiazol-
5-ylmethyl)-N'-methyl -N'-nitro-guanidine, in or on soybean, hulls at
2.0 ppm and soybean, aspirated grain fractions at 0.08 ppm. EPA's
assessment of exposures and risks associated with establishing
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by thiamethoxam as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in the
final rule published in the Federal Register of June 22, 2007, (72 FR
34401) (FRL-8133-6).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be

determined, the lowest dose at which adverse effects of concern are
identified (the LOAEL) or a Benchmark Dose (BMD) approach is sometimes
used for risk assessment. Uncertainty/safety factors (UFs) are used in
conjunction with the POD to take into account uncertainties inherent in
the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. Safety is assessed for acute and chronic dietary
risks by comparing aggregate food and water exposure to the pesticide
to the acute population adjusted dose (aPAD) and chronic population
adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the
POD by all applicable UFs. Aggregate short-, intermediate-, and
chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
    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
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for thiamethoxam used for
human risk assessment is discussed in Unit Unit III.B. of the final
rule published in the Federal Register of June 22, 2007 (72 FR 34401)
(FRL-8133-6).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to thiamethoxam, EPA considered exposure under the petitioned-
for tolerances as well as all existing thiamethoxam tolerances in 40
CFR 180.565. EPA assessed dietary exposures from thiamethoxam in food
as follows:
    For both acute and chronic exposure assessments EPA combined
residues of clothianidin coming from thiamethoxam with residues of
thiamethoxam per se. As discussed above, thiamethoxam's major
metabolite is CGA-322704, which is also the registered active
ingredient clothianidin. There is available information indicating that
thiamethoxam and clothianidin have different toxicological effects in
mammals and should be assessed separately, however, these exposure
assessments for this action incorporated the total residue of
thiamethoxam and clothianidin to estimate dietary exposure. This
aggregation of thiamethoxam and clothianidin began with the initial
assessment of thiamethoxam, prior to the requested registration of
clothianidin as an active ingredient, and is being maintained in this
action for historical purposes. In future assessments, as time and
resources allow, the EPA will provide a rationale for the separate
analysis of risks coming from thiamethoxam and clothianidin, and will
conduct separate evaluations of exposure and risk for each chemical.
The combining of these residues, as was done in these assessments,
results in highly conservative estimates of dietary exposure and risk.
    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. In estimating acute dietary
exposure, EPA used food consumption information from the U.S.
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA assumed maximum residues of thiamethoxam and
clothianidin observed in the thiamethoxam field trials. It was also
assumed that 100% of crops with registered or requested uses of
thiamethoxam are treated. This assumption is highly conservative with
respect to thiamethoxam use and removes the need to include residues of
clothianidin coming from the use of that active ingredient.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Nationwide CSFII. As to residue levels in food, EPA assumed
maximum residues of thiamethoxam and clothianidin observed in the
thiamethoxam field trials. It was also assumed that 100% of crops with
registered or requested uses of thiamethoxam are treated. This
assumption is highly conservative with respect to thiamethoxam use and
removes the need to include residues of clothianidin coming from the
use of that active ingredient.
    A complete listing of the inputs used in these assessments can be
found in the document titled ``Thiamethoxam Acute and Chronic Aggregate
Dietary and Drinking Water Exposure and Risk Assessments for FIFRA
Section 3 Registration,'' available in the docket EPA-HQ-OPP-2006-0523,
http://www.regulations.gov.
    iii. Cancer. A quantitative cancer exposure assessment is not
necessary because EPA concluded that thiamethoxam is ``Not Likely to be
Carcinogenic to Humans'' based on convincing evidence that a non-
genotoxic mode of action for liver tumors was established in the mouse
and that the carcinogenic effects are a result of a mode of action
dependent on sufficient amounts of a hepatotoxic metabolite produced
persistently. Therefore, the Agency concluded that thiamethoxam is not
expected to pose a carcinogenic risk and an exposure assessment
pertaining to cancer risk is not necessary.
    iv. Anticipated residue information. Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and information on the anticipated
residue levels of pesticide residues in food and the actual levels of
pesticide residues that have been measured in food. For the present
action, EPA has used maximum residue values from field trials. These
trials are designed to produce worst-case residue levels in foods, and
likely overestimate residues of thiamethoxam and clothianidin that may
actually occur in or on foods.
    2. Dietary exposure from drinking water. Thiamethoxam is expected
to be persistent and mobile in terrestrial and aquatic environments.
These fate properties suggest that thiamethoxam has a potential to move
into surface water and shallow ground water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for thiamethoxam in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the environmental
fate characteristics of thiamethoxam. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and the Screening Concentration in Ground Water
(SCI-GROW) models, the estimated drinking water concentrations (EDWCs)
of thiamethoxam for acute exposures are estimated to be 12.26 parts per
billion (ppb) for surface water and 7.94 ppb for ground water. The
EDWCs for chronic exposures are

estimated to be 1.29 ppb for surface water and 7.94 ppb for ground
water.
    The registrant has conducted small-scale prospective ground water
studies in several locations in the United States to investigate the
mobility of thiamethoxam in a vulnerable hydrogeological setting. A
review of those data shows that generally residues of thiamethoxam as
well as CGA-322704 are below the limit of quantitation (0.05 ppb. When
quantifiable residues are found, they are sporadic and at low levels.
The maximum observed residue levels from any monitoring well were 1.0
ppb for thiamethoxam and 0.73 ppb for CGA-322704. These values are well
below the modeled estimates summarized above, indicating that the
modeled estimates are, in fact, protective of what actual exposures are
likely to be.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For both the acute and chronic
assessments the acute EDWC of 12.26 ppb (0.0123 ppm) was used as a
worst-case estimate of exposure via 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).
    Thiamethoxam is registered for use on turfgrass on golf courses,
residential lawns, commercial grounds, parks, playgrounds, athletic
fields, landscapes, interiorscapes and sod farms. Thiamethoxam is
applied by commercial applicators only. Therefore, exposures resulting
from homeowner applications were not assessed. However, entering areas
previously treated with thiamethoxam could lead to exposures for adults
and children. As a result, risk assessments have been completed for
postapplication scenarios. Short-term exposures (1 to 30 days of
continuous exposure) may occur as a result of activities on treated
turf. There are no use patterns for thiamethoxam that indicate
intermediate-term (1 to 6 months of continuous exposure) or chronic
non-dietary exposures are likely to occur.
    Dermal exposures were assessed for adults and children. Oral non-
dietary ingestion exposures (i.e. soil ingestion, and hand-/object-to-
mouth) were assessed for children as well. Since all postapplication
scenarios occur outdoors the potential for inhalation exposure is
negligible and therefore does not require an inhalation exposure
assessment. For purposes of this assessment exposure from residential
lawns is used to represent the worst case scenario for both dermal and
oral postapplication exposure.
    Postapplication dermal exposure resulting from contact with treated
turf was assessed using the EPA's Standard Operating Procedures for
Residential Exposure and a chemical-specific turf transfer residue
study.
    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.''
    Thiamethoxam is a member of the neonicotinoid class of pesticides
and produces, as a metabolite, another neonicotinoid, clothianidin.
Structural similarities or common effects do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same sequence of
major biochemical events (EPA, 2002). Although clothianidin and
thiamethoxam bind selectively to insect nicotinic acetylcholine
receptors (nAChR), the specific binding site(s)/receptor(s) for
clothianidin, thiamethoxam, and the other neonicotinoids are unknown at
this time. Additionally, the commonality of the binding activity itself
is uncertain, as preliminary evidence suggests that clothianidin
operates by direct competitive inhibition, while thiamethoxam is a non-
competitive inhibitor. Furthermore, even if future research shows that
neonicotinoids share a common binding activity to a specific site on
insect nicotinic acetylcholine receptors, there is not necessarily a
relationship between this pesticidal action and a mechanism of toxicity
in mammals. Structural variations between the insect and mammalian
nAChRs produce quantitative differences in the binding affinity of the
neonicotinoids towards these receptors, which, in turn, confers the
notably greater selective toxicity of this class towards insects,
including aphids and leafhoppers, compared to mammals. While the
insecticidal action of the neonicotinoids is neurotoxic, the most
sensitive regulatory endpoint for thiamethoxam is based on unrelated
effects in mammals, including effects on the liver, kidney, testes, and
hematopoietic system. Additionally, the most sensitive toxicological
effect in mammals differs across the neonicotinoids (e.g., testicular
tubular atrophy with thiamethoxam; mineralized particles in thyroid
colloid with imidacloprid). Thus, there is currently no evidence to
indicate that neonicotinoids share common mechanisms of toxicity, and
EPA is not following a cumulative risk approach based on a common
mechanism of toxicity for the neonicotinoids. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the 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. In the developmental
studies, there is no evidence of increased quantitative or qualitative
susceptibility of rat or rabbit fetuses to in utero exposure to
thiamethoxam. The developmental NOAELs are either higher than or equal
to the maternal NOAELs. The toxicological effects in fetuses do not
appear to be any more severe than those in the dams or does. In the rat
developmental neurotoxicity study, there was no quantitative evidence
of increased susceptibility.
    There is evidence of increased quantitative susceptibility for male
pups in both two-generation reproductive studies. In one study, there
are no toxicological effects in the dams whereas for the pups, reduced
bodyweights are observed at the highest dose level, starting on day 14
of lactation. This contributes to an overall decrease in bodyweight
gain during the entire lactation period. Additionally, reproductive
effects in males appear in the F1 generation in the form of
increased incidence and severity of testicular tubular atrophy. These
data are considered to be evidence of increased quantitative
susceptibility for male pups (increased incidence of testicular tubular
atrophy at 1.8

milligrams/kilogram/day (mg/kg/day) when compared to the parents
(hyaline changes in renal tubules at 61 mg/kg/day; NOAEL is 1.8 mg/kg/
day).
    In the more recent two-generation reproduction study, the most
sensitive effect was sperm abnormalities at 3 mg/kg/day (the NOAEL is
1.2 mg/kg/day) in the F1 males. This study also indicates
increased susceptibility for the offspring for this effect.
    Although there is evidence of increased quantitative susceptibility
for male pups in both reproductive studies, NOAELs and LOAELs were
established in these studies and the Agency selected the NOAEL for
testicular effects in F1 pups as the basis for risk
assessment. The Agency has confidence that the NOAEL selected for risk
assessment is protective of the most sensitive effect (testicular
effects) for the most sensitive subgroup (pups) observed in the
toxicological database.
    Due to the finding of quantitative sensitivity in the reproduction
studies, the EPA conducted a degree of concern analysis to assess the
residual uncertainties for pre- and/or postnatal susceptibility. The
Agency concluded that there is low concern for an increased
susceptibility in the young given:
    i. There was no increased sensitivity (qualitative or quantitative)
in the rat developmental, rabbit developmental and rat developmental
neurotoxicity studies.
    ii. There was a clear NOAEL identified for the effects in pups in
the rat reproduction studies where sensitivity was seen.
    iii. The Agency selected this NOAEL as the basis for risk
assessment.
    3. Conclusion. The final rule published in the Federal Register of
January 5, 2006 (http://www.epa.gov/fedrgstr/EPA-PEST/2005/January/Day-
05/p089.htm) reported that the EPA had determined that the 10X special
safety factor to protect infants and children should be retained for
thiamethoxam based on the following factors: Effects on endocrine
organs observed across species; the significant decrease in alanine
amino transferase levels in the companion animal studies and in the dog
studies; the mode of action of this chemical in insects (interferes
with the nicotinic acetyl choline receptors of the insect's nervous
system); the transient clinical signs of neurotoxicity in several
studies across species; and the suggestive evidence of increased
quantitative susceptibility in the rat reproduction study.
    Since that determination, EPA has received and reviewed a
Developmental Neurotoxicity (DNT) study in rats and an additional
Reproduction study in rats. Taking the results of this study into
account, EPA has determined that reliable data show the safety of
infants and children would be adequately protected if the FQPA SF were
reduced to 1X. That decision is based on the following findings:
    i. The toxicity database for thiamethoxam is complete, including
acceptable/guideline developmental toxicity, 2-generation reproduction,
and developmental neurotoxicity studies designed to detect adverse
effects on the developing organism, which could result from the
mechanism that may have produced the decreased alanine amino
transferase levels.
    ii. For the reasons discussed above, there is low concern for an
increased susceptibility in the young.
    iii. Although there is evidence of neurotoxicity after acute
exposure to thiamethoxam at doses of 500 mg/kg/day including drooped
palpebral closure, decrease in rectal temperature and locomotor
activity and increase in forelimb grip strength, no evidence of
neuropathology was observed. These effects occurred at doses at least
fourteenfold and 416-fold higher than the doses used for the acute, and
chronic risk assessments, respectively; thus, there is low concern for
these effects since it is expected that the doses used for regulatory
purposes would be protective of the effects noted at much higher doses.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on assumption that the maximum residues of thiamethoxam and
clothianidin observed in the thiamethoxam field trials were remaining
on crops. Although there is available information indicating that
thiamethoxam and clothianidin have different toxicological effects in
mammals and should be assessed separately, the residues of each have
been combined in these assessments to ensure that the estimated
exposures of thiamethoxam do not underestimate actual potential
thiamethoxam exposures. An assumption of 100% crop treated was made for
all foods evaluated in the assessments. For both the acute and chronic
assessments the acute EEC of 12.26 ppb (0.0123 ppm) was used as a
worst-case estimate of exposure via drinking water. Compared to the
results from small-scale prospective ground water studies where the
maximum observed residue levels from any monitoring well were 1.0 ppb
for thiamethoxam and 0.73 ppb for CGA-322704, the modeled estimates are
protective of what actual exposures are likely to be. Similarly
conservative Residential SOPs as well as a chemical-specific turf
transfer residue (TTR) study were used to assess post-application
exposure to children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by thiamethoxam.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to thiamethoxam will occupy 3% of the aPAD for children 1 to 2 years
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
thiamethoxam from food and water will utilize 42% of the cPAD for
children 1 to 2 years old, the population group with greatest exposure.
Based on the use patterns proposed, chronic residential exposure to
residues of thiamethoxam is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Thiamethoxam is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for thiamethoxam. The level of concern for the margin of
exposure (MOE) is 100 for all residential uses (i.e., MOEs less than
100 indicate potential risks of concern). Using the exposure
assumptions described in this unit for short-term exposures, EPA has
concluded that food, water, and

residential exposures aggregated result in aggregate MOEs of 730
through 2,800 for all exposure scenarios (dermal exposures, and oral
non-dietary ingestion) for infants, children and adults.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). There are no
use patterns for thiamethoxam that indicate intermediate-term (1 to 6
months of continuous exposure) exposures are likely to occur.
    5. Aggregate cancer risk for U.S. population. The Agency has
classified thiamethoxam as not likely to be a human carcinogen based on
convincing evidence that a non-genotoxic mode of action for liver
tumors was established in the mouse and that the carcinogenic effects
are a result of a mode of action dependent on sufficient amounts of a
hepatotoxic metabolite produced persistently. Thiamethoxam is not
expected to pose a cancer risk.
    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 thiamethoxam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid
chromatography/ultraviolet (HPLC/UV) or mass spectrometry (MS)) is
available to enforce the tolerance expression. 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>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no CODEX or Mexican maximum residue limits (MRLs) for
thiamethoxam. A number of Canadian MRLs exist for this chemical and are
in accord with U.S. tolerances. The new/revised tolerances established
by this rule have been derived using the NAFTA Tolerance Harmonization
Spreadsheet.

V. Conclusion

    Based upon review of the supporting data, EPA has determined that
tolerance levels for the following crops should be set as follows:
soybean, hulls at 2.0 ppm; and soybean, aspirated grain fractions at
0.08 ppm. Therefore, tolerances are established for the combined
residues of thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-
methyl-N-nitro-4H-1,3,5-oxadiazin-4-imine, and its metabolite, CGA-
322704, N-(2-chloro-thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine,
in or on soybean, hulls at 2.0 ppm and soybean, aspirated grain
fractions at 0.08 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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 9, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.565 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec.  180.565  Thiamethoxam; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Soybean, aspirated grain fractions...................               0.08
Soybean, hulls.......................................                2.0
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E8-8398 Filed 4-17-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 82, Number 124 (Thursday, June 29, 2017)]
[Notices]
[Pages 29602-29604]
[FR Doc No: 2017-13582]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81007; File No. SR-FINRA-2017-021]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of a Proposed Rule Change To Amend
FINRA Rule 7730 To Make Available a New TRACE Security Activity Report

June 23, 2017.
    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 June 19, 2017, Financial Industry Regulatory Authority, Inc.
(``FINRA'') 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 FINRA. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to amend FINRA Rule 7730 to make available a new
TRACE Security Activity Report.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA 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, FINRA 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. FINRA 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
    Rule 7730 (Trade Reporting and Compliance Engine (TRACE)), among
other things, sets forth the TRACE data products offered by FINRA in
connection with TRACE-Eligible Securities.\3\ FINRA is proposing to
amend Rule 7730 to make available a new TRACE Security Activity Report,
which would provide aggregated statistics by security for TRACE-
Eligible Securities that are corporate or agency bonds (collectively
``CA Bonds'').\4\
---------------------------------------------------------------------------

    \3\ Rule 6710 (Definitions) provides that a ``TRACE-Eligible
Security'' is a debt security that is United States (``U.S.'')
dollar-denominated and issued by a U.S. or foreign private issuer,
and, if a ``restricted security'' as defined in Securities Act Rule
144(a)(3), sold pursuant to Securities Act Rule 144A; or is a debt
security that is U.S. dollar-denominated and issued or guaranteed by
an Agency as defined in paragraph (k) or a Government-Sponsored
Enterprise as defined in paragraph (n); or a U.S. Treasury Security
as defined in paragraph (p). ``TRACE-Eligible Security'' does not
include a debt security that is issued by a foreign sovereign or a
Money Market Instrument as defined in paragraph (o).
    \4\ FINRA intends to establish a fee for the TRACE Security
Activity Report prior to the effective date of the instant proposed
rule change. The fee will be established pursuant to a separate rule
filing.
---------------------------------------------------------------------------

    The proposed TRACE Security Activity Report would contain basic
descriptive security elements for each CA Bond (such as the issuer's
name and the security's coupon and maturity date). In addition, the
proposed report would provide subscribers with transaction totals, a
measure of market concentration to indicate the extent to which
activity in the security is concentrated within a few market
participant identifiers (MPIDs),\5\ and more detailed aggregate par
value volume information in a particular CA Bond than would be
available in Real-Time TRACE transaction data. Today, the actual par
value traded is available in the short-term only for transactions with
sizes up to the applicable dissemination cap.\6\ Transactions with
sizes over the capped amount become available only after 18 months as
part of the Historic TRACE Data product.
---------------------------------------------------------------------------

    \5\ One member may use multiple MPIDs.
    \6\ Due to transaction confidentiality concerns, FINRA has
applied ``dissemination caps'' for purposes of dissemination.
Specifically, for transactions in investment grade corporate bonds
and in agency bonds over a 5 million dollar par value, TRACE
disseminates the size as ``5MM+.'' For transactions in non-
investment grade corporate bonds over a 1 million dollar par value,
TRACE disseminates the size as ``1MM+.''
---------------------------------------------------------------------------

    The proposed TRACE Security Activity Report would provide insight
into the level of activity in CA Bonds during a given month.
Specifically, in addition to overall aggregate par value volume, the
proposed TRACE Security Activity Report would provide information on
the par value volume of customer buys, the par value volume of customer
sells and the par value volume of inter-dealer transactions. The
proposed TRACE Security Activity Report would reflect par value volume
information using either capped amounts or actual par value volume, as
follows. For uncapped transactions, the proposed TRACE Security
Activity Report would reflect the actual trade size of each transaction
(i.e., the transaction size disseminated in Real-Time TRACE transaction
data). If there are six or more capped transactions disseminated during
the calendar month, the aggregate par value volume would reflect the
actual trade size of each transaction, as well as the par value traded
that falls within specified size categories (e.g., the aggregate par
value traded for transactions with a size greater than the
dissemination cap up to $10 million and the aggregate par value traded
for transactions with a size greater than $10 million).\7\
---------------------------------------------------------------------------

    \7\ If the SEC approves this proposal, the size categories will
be announced in the Regulatory Notice announcing the effective date
of the new TRACE Security Activity Report. The size category
thresholds will be based on a multiple of the dissemination cap,
e.g., up to or over $10 million, which would be two times the
investment grade dissemination cap. The number of size categories
also may be adjusted (e.g., up to $10 million; over $10 million up
to $20 million; over $20 million) based on FINRA's experience with
the data product.
---------------------------------------------------------------------------

    However, if there are fewer than six disseminated capped
transactions during the calendar month, the TRACE Security Activity
Report would reflect the capped volumes disseminated in Real-Time TRACE
transaction data. Accordingly, the report would only reflect the actual
par value traded (i.e., the amount reported by the member to TRACE)
where there have been at least

six capped transactions during the calendar month. As a measure to
further address possible confidentiality concerns, FINRA proposes that
the TRACE Security Activity Report be provided on a 90-day delay.
    The proposed TRACE Security Activity Report also would provide the
total number of transactions disseminated for each CA Bond as well as
the number of customer buy transactions, the number of customer sell
transactions and the number of inter-dealer transactions. In addition,
the proposed TRACE Security Activity Report would provide incremental
ranges (e.g., fewer than or equal to 5, between 6 and 10, etc.) for the
number of transactions with a par value volume within specified size
categories (e.g., the number of trades with a size greater than the
dissemination cap up to $10 million, and the number of trades with a
size of $10 million or greater).
    The proposed TRACE Security Activity Report also would provide
information regarding the number of unique reporting MPIDs and
statistics for the aggregate activity of the five most active MPIDs in
each CA Bond. Specifically, the proposed TRACE Security Activity Report
would provide the number of unique reporting MPIDs for disseminated
uncapped and capped transactions. The number of unique reporting MPIDs
would be provided by displaying the actual number of unique MPIDs where
there are six or more unique MPIDs, or ``1 to 5,'' as applicable, where
there are five or fewer reporting MPIDs. For capped transactions, the
number of unique reporting MPIDs would be provided by displaying the
actual number of unique MPIDs where there are six or more unique MPIDs,
or ``0'' or ``1 to 5,'' as applicable, where there are five or fewer
reporting MPIDs.
    The market participants that engaged in the transactions will not
be identified in the proposed TRACE Security Activity Report. The TRACE
Security Activity Report also would provide the percentage of the total
number of transactions traded by the top five MPIDs for each CUSIP and
the percentage of total par value traded by the top five MPIDs for each
CUSIP. The percentage of the total number of transactions and total par
value traded for the top 5 MPIDs will be provided irrespective of the
number of capped transactions (e.g., where there is only one MPID, the
number of unique MPIDs will be displayed as ``1 to 5'' and both the
number of transactions and par value percentages will be displayed as
100%).
    FINRA believes that the proposed TRACE Security Activity Report may
be useful to interested parties for business as well as regulatory
purposes. For example, members may use the information provided in the
TRACE Security Activity Report to better ascertain their relative level
of trading activity in particular CA Bonds. Interested parties also may
use the information in the proposed report in connection with
regulatory obligations--e.g., in assessing, classifying and reviewing
the liquidity risk of individual securities pursuant to Rule 22e-4
under the Investment Company Act.\8\
---------------------------------------------------------------------------

    \8\ See SEC Press Release 2016-215 (October 13, 2016) (SEC
Adopts Rules to Modernize Information Reported by Funds, Require
Liquidity Risk Management Programs, and Permit Swing Pricing). See
also 17 CFR 270.22e-4.
---------------------------------------------------------------------------

    If the Commission approves the proposed rule change, FINRA will
announce the effective date of the proposed rule change in a Regulatory
Notice. The effective date will be no later than 365 days following SEC
approval.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\9\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

    Pursuant to the proposal, FINRA would make available to subscribers
an optional data product to provide aggregated statistics by security
for CA Bonds. FINRA believes that the TRACE Security Activity Report
could benefit market participants and others interested in corporate
and agency bond transaction data, including information on actual
transaction volume that currently would not be ascertainable for 18
months after the date of the transaction (as part of the Historic TRACE
Data product). FINRA believes that the measures proposed to mitigate
any potential confidentiality concerns--e.g., aggregate volume would
reflect actual volume only where there were six or more total
disseminated capped transactions during the calendar month--strikes an
appropriate balance in providing additional transparency on the overall
trading activity in a particular CA Bond, while remaining sensitive to
confidentiality concerns. Thus, FINRA believes that the proposed rule
change is in the public interest and consistent with the Act.

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

    FINRA does not believe that the proposed rule change would result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.
Economic Impact Analysis
    FINRA's existing Real-Time TRACE data product provides transaction
data for the following Data Sets: Corporate Bond Data, Agency Data Set,
SP Data Set, and Rule 144A Data Set. As detailed above, FINRA is
proposing to create a TRACE Security Activity Report to provide
additional aggregated statistics by security for CA Bonds, as an
alternative or in addition to the transaction data contained in the
Real-Time TRACE product. The TRACE Security Activity Report would be
available on an optional basis to subscribers. The proposed rule change
would expand the benefits of FINRA's TRACE initiatives by providing
additional transparency on CA Bonds, as the product would provide
subscribers with more detailed volume information on the overall
trading activity in a particular CA Bond.
    The proposal to create a new TRACE Security Activity Report would
not impose any additional reporting requirements or costs on firms, and
the purchase of TRACE data products would continue to be optional for
market participants and others and, as a result, would have no direct
impact on firms. However, FINRA also considered the potential for
indirect costs regarding possible information leakage due to the
inclusion of the number of unique reporting MPIDs. FINRA believes that
information contained in the TRACE Security Activity Report alone is
not sufficient to discover the true identity of other MPIDs by market
participants, where the only information used in the analysis is the
information to be contained in this product. However, there may exist
other publicly available datasets that can be used in conjunction with
the proposed TRACE Security Activity Report.\10\ FINRA acknowledges

the potential for reverse engineering of the information contained in
the TRACE Security Activity Report, in particular for bonds that are
traded by a few market participants in a given month, to determine the
true identities of other market participants, and FINRA has taken a
number of measures, such as displaying information in buckets as
discussed above, to reduce this risk and mitigate any potential
impacts.
---------------------------------------------------------------------------

    \10\ One such dataset is sold by the National Association of
Insurance Commissioners (NAIC) and contains detailed information
about insurance company bond transactions, including the CUSIP of
the bond traded along with identities of insurance companies and the
dealers with whom each trade is completed, the date of the
transaction, the amount traded and the price of the transaction. See
Maureen O'Hara, Yihui Wang, and Xing (Alex) Zhou, The Execution
Quality of Corporate Bonds (June 1, 2016), http://papers.ssrn.com/sol3/Papers.cfm?abstract_id=2680480.
---------------------------------------------------------------------------

    The proposed TRACE Security Activity Report would include a ``top
5'' snapshot for each CA Bond showing the percentage of the total
number of transactions that is represented by the activity of the top
five MPIDs, and the percentage of the total par value traded by the top
five MPIDs. To the extent that market participants extract non-reported
information from this report about concentration and competition in a
specific bond, they may alter their demand, supply and pricing
accordingly. Customers may potentially find it easier or harder to
trade some bonds, and may see a change in the costs of trading,
including search costs. Such changes may eventually express themselves
as an indirect impact on the liquidity of these bonds.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2017-021 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2017-021. 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
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. 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-FINRA-2017-021 and should be
submitted on or before July 20, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-13582 Filed 6-28-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 181 (Thursday, September 18, 2014)]
[Notices]
[Pages 56105-56107]
[FR Doc No: 2014-22257]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2014-0018]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA confirms its decision to exempt 88 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions enable these individuals to operate CMVs in interstate
commerce.

DATES: The exemptions were effective on August 19, 2014. The exemptions
expire on August 19, 2016.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, R.N., Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Room
W64-224, Department of Transportation, 1200 New Jersey Avenue SE.,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's Privacy Act Statement for the Federal
Docket Management System (FDMS) published in the Federal Register on
January 17, 2008 (73 FR 3316).

II. Background

    On July 17, 2014, FMCSA published a notice of receipt of Federal
diabetes exemption applications from 88 individuals and requested
comments

from the public (79 FR 41723). The public comment period closed on
August 18, 2014, and three comments were received.
    FMCSA has evaluated the eligibility of the 88 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

III. Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 88 applicants have had ITDM over a range of 1 to 38 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the July 17, 2014, Federal Register
notice and they will not be repeated in this notice.

IV. Discussion of Comments

    FMCSA received three comments in this proceeding. The comments are
discussed below.
    One anonymous commenter explained that all drivers with type 1 and
type 2 diabetes spend much time and effort complying with local and
state regulations.
    Two anonymous commenters are in favor of granting the exemptions to
the drivers.

V. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

VI. Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (4) that
each individual provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

VII. Conclusion

    Based upon its evaluation of the 88 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above 49 CFR
391.64(b)):

Charles Ackerman Jr. (NJ), William J. Applebee (WI), Matthew D. Barney
(IA), Benjamin L. Baxter (MI), Stephen M. Berggren (MN), Robert A.
Boyle (ID), Patrick J. Burns (MN), Mathew A. Cardon (AZ), Robert L.
Caudill (OH), Vernon R. Cornish (AR), Charles L. Cran (WI), John W.
Crook Jr. (IA), Michael A. Dinkel (NJ), William C. Dixon (TX), Donald
R. Dunaway (OH), Kevin W. Elder (NC), Michael J. Eldridge, Sr. (IA),
Johnathon C. Ely (IN), Kevin D. Erickson (WI), Wayne D. Erickson (MN),
Walter C. Evans (CT), Joby E. Foshee, IV (MS), Lawrence H. Fox (NH),
Troy C. Frank (NE), Robert T. Frankfruter (CO), Koby L. Garman (PA),
Dale A. Godejohn (ND), Robert R. Gonzales (CA), Norman D. Groves (MO),
Kenneth F. Gwaltney (IN), Mathew R. Hale (KS), Donald K. Hamilton (FL),
John L. Holtzclaw (MO), Christopher H. Horn (NH), Donald L. Howard
(TX), Jared E. Hubbard (TX), Roger C. Hulce (UT), Kip J. Kauffman (WI),
Christopher J. Kittoe (WI), Joshua L. Kroetch (MN), Wesley S. Langham
(IL), Andrew K. Lofton (AL), Salvador Lopez (AZ), Joseph M. Macias
(NM), Robert J. Marino (NJ), Kasey L. Martin (TX), David J. McCoy (UT),
William E. Medlin (MN), Anthony J. Miller (MN), Charles A. Napoles, Jr.
(NJ), Kathryn J. Nelms (KS), Antonio C. Oliveira (PA), Kent E. Oswald
(NY), Christopher P. Overton (IL), Ronald E. Patrick (IN), Ronald E.
Patterson, Jr. (TN), Stephen J. Pelton (PA), Bryant S. Perry (NC),
Kenneth R. Perschon (IL), Joseph R. Polhamus (LA), Brian J. Rajkovich
(CA), Joseph E. Resetar (NJ), Donnell T. Rhone (TN), Charles E. Rich
(KS), Rodney B. Roberets (MS), Arlan M. Roesler (WI), Mark J. Rone
(IL), Ronny J. Sanders (UT), Barry J. Sanderson (MT), Russell E. Shipp
(RI), David J. Standley (WA), John J. Steigauf (MN), Berton W. Stroup
(PA), Scott W. Stutts (AR), Jason B. Taylor (NC), Ronnie P. Thomas
(TN),

William L. Thompson (MN), Juan Villanueva (TX), Robert D. Watts (TX),
Cindy L. Wells (NY), Charles W. White (IN), Herman D. Whitehurst (AR),
Kermit D. Williams (KY), Michael D. Worl (MT), Tommy W. Wornick (TX),
Robert T. Yeftich (IN), Alan C. Yeomans (CT), Chad C. Yerkey (PA)

    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption is
valid for two years unless revoked earlier by FMCSA. The exemption will
be revoked if the following occurs: (1) The person fails to comply with
the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before I was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: September 12, 2014.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-22257 Filed 9-17-14; 8:45 am]
BILLING CODE 4910-EX-P