[Federal Register Volume 88, Number 84 (Tuesday, May 2, 2023)]
[Notices]
[Pages 27539-27542]
[FR Doc No: 2023-09207]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97383; File No. SR-ICEEU-2023-012]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing and Immediate Effectiveness of Proposed Rule Change Relating
to Amendments to the Futures and Options Default Management Policy

April 26, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 13, 2023, ICE Clear Europe Limited (``ICE Clear Europe'' or
the ``Clearing House'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule changes described in
Items I, II and III below, which Items have been prepared by ICE Clear
Europe. ICE Clear Europe filed the proposed rule change pursuant to
Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(4)(ii)
thereunder,\4\ such that the proposed rule change was immediately
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(4)(ii).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    ICE Clear Europe Limited (``ICE Clear Europe'' or the ``Clearing
House'') is proposing to adopt a new Futures and Options Default
Management Policy (``Policy''),\5\ to replace its existing Futures and
Options Default Management Policy. The new Policy is intended to
provide clearer procedures and guidance for managing a default by one
or more Clearing Members.
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    \5\ Capitalized terms used but not defined herein have the
meanings specified in the ICE Clear Europe Clearing Rules and the
Futures and Options Management Policy.
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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, ICE Clear Europe 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. ICE Clear Europe has prepared summaries,
set forth in sections (A), (B), and (C) below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

(a) Purpose
    ICE Clear Europe is proposing to adopt a new Futures and Options
Default Management Policy, which would address procedures and
requirements for the Clearing House's management of an Event of Default
with respect to an F&O Clearing Member consistent with the requirements
of Clearing House's Rules and Procedures. The Policy would replace the
existing Futures and Options Default Management Policy. The new Policy
is designed to more clearly reflect and describe various aspects of the
Clearing House's existing default management practices and procedures
for F&O Contracts (and would not generally change those practices and
procedures). The new Policy would also clarify and enhance certain
governance matters relating to F&O default management, as well as
certain practices relating to hedging strategy following a default, as
discussed below. The new Policy would also provide for certain
additional scenarios to be used in default testing drills, as discussed
below. The new Policy would also eliminate certain outdated or
superseded provisions or the provisions that are no longer applicable.
    The Policy would include a background section describing the
overall purpose of the document, which is to provide structure and
guidance for ICE Clear Europe's management of an Event of Default
within the framework

of the Rules and applicable law, and without attempting to specify the
actions the Clearing House would take in all or any particular
situations. The background section would also set out the scope of the
Policy, which is to set out the key factors to consider in declaring
and managing an Event of Default. In addition, it would present the
Clearing House's three lines of defense model for managing risks. The
First Line of defense would be responsible for ensuring the Policy
requirements are met and would consist of the Clearing Risk, Treasury,
Operations, Legal, Compliance and Finance Departments. The Second Line
of defense would be responsible for challenging the First Line on
adherence to the requirements of the Policy and would be the Risk
Oversight Department. The Third Line would provide independent and
objective assurance to the Board and would be the Internal Audit
Function.
    The Policy would set out the Clearing House's overall objectives
when declaring and managing an Event of Default, which are generally to
take timely action to return the Clearing House, as soon as reasonably
practicable, to a matched book while aiming to contain losses and
liquidity pressures. Depending on the circumstances, other objectives
may include ensuring timely completion of settlement, limiting
disruption to the market and closing out the defaulter's positions and
liquidating collateral in a prudent and orderly manner. The objectives
reflect that the default management framework will be guided by the
relevant Rules as well as the Policy and any supporting procedures that
may be adopted.
    The Policy would detail the governance and responsibilities of
various personnel and committees with respect to default management.
(These provisions are intended to more clearly document existing
practice, rather than change that practice.) The Policy would in
particular reflect the following: the Board of Directors has delegated
to the President the authority to declare an Event of Default and take
all actions the Clearing House may take under the rules in managing an
event of default. The President has the discretion to consult the ERC
Default Management Committee (``DMC''), which is a subcommittee of the
Executive Risk Committee. The President has the authority to make final
decisions but may delegate powers as appropriate. The DMC would also
assume the responsibilities of the President in the declaration and
management of an Event of Default if the President is unavailable. The
DMC would require a quorum of the majority of voting members of the
Executive Risk Committee for the DMC to make decisions and the
decisions would have to be by unanimous agreement of the voting members
of the Executive Risk Committee present in the meeting. If there are
dissenting views at the DMC level, the issue must be escalated to the
Board. Consistent with the requirements of the Rules, the Policy would
state that a declaration of an Event of Default would be limited to
circumstances where an event in Rule 901(a) has occurred with respect
to a Clearing Member.
    The Policy would also outline various aspects of default management
for which processes and procedures should be in place (which processes
and procedures are not set out in the Policy itself). The Policy would
state that procedures for pre-default monitoring must be in place in
order to identify early circumstances that may develop into Events of
Default, and procedures should be in place to quickly suspend a
defaulting Clearing Member's access to trading and prevent payments or
collateral transfers to the defaulting Clearing Member. Furthermore,
the Policy would set out that management information would have to be
available on short notice to support the President and must be
sufficiently detailed to allow for risk management decisions, including
key risk details on positions, collateral and liquidity. The Policy
would also state that processes should be in place to establish hedging
strategies and support timely liquidation of positions. Pursuant to the
existing Rules, the Clearing House may engage in hedging trades ahead
of liquidating the defaulter's portfolio. The Policy would provide that
advice on hedging strategy may be sought from relevant exchanges or
market participants. Any hedging strategy would need to be approved by
the President before execution. In terms of liquidation, the Policy
would provide that a process to liquidate positions via auctions or
private sale would have to be in place. For an auction, the Policy
would state that factors such as participation and possible risk of
auction failure should be considered in determining auction
composition. If there is a dependency on a third party, arrangements
would have to be in place in case the third party is not available.
    The Policy would also address the need for a defined process for
client porting (and for liquidation where porting cannot occur). A
notification of the opening of the porting window would also have to be
communicated to the market in order to allow clients of the defaulting
Clearing Member to participate in the porting process. A process would
have to be defined to support the porting of client positions and
collateral pursuant to the Rules and Standard Terms but subject to
applicable law.
    The Policy would also address the Clearing House's communication
strategy around defaults. Prior to an Event of Default, the Clearing
House would endeavor to prevent communications with the concerned
Clearing Member becoming public, unless allowed under Rule 106 or
required by the Clearing Member's regulators, the Clearing House's
regulators, and/or other government authorities. The Clearing House
would serve a default notice on the defaulter as soon as practicable
after declaring a default and issue a circular in respect of any
default notice, consistent with the Rules. ICE Clear Europe would
engage with other ICE exchanges, clearing organizations, and external
legal advisors when appropriate.
    The Policy would reflect the requirement of the Rules that post-
default, a net sum would to be calculated according to the methodology
in the Rules.
    The policy would also require the test and review of the default
procedures on a quarterly basis, through practicing certain aspects of
the default management process. In addition, the Clearing House would
have to conduct a default test on an annual basis with mandatory
participation of the Clearing Members. Moreover, a multi-year default
management plan would have to be maintained and approved by the
Executive Risk Committee and shared with the Board Risk Committee. The
multi-year default management plan would have to consider Default
Member Scenarios (looking at representative credit and market risk
scenarios over the testing cycle), Other Variables (such as the timing
of the default and other potential constraints), Liquidity Management
(including liquidity issues arising from sourcing liquidity, collateral
liquidation and investment counterparty failure), End of Default and
Recovery (including testing powers of assessment and recovery
mechanisms), People (including relevant personnel and testing the
ability of departments to support default management), and Governance
(including testing executive governance, communication with the Board
and Board approval). Additional testing should be conducted following
material changes in the default management process or otherwise where
necessary, and more extreme scenarios

or combinations of scenarios should be considered to identify weakness
in the default management process. The multi-year default management
plan along with the scope, results and lessons learned of each default
test would be shared with the Board Risk Committee and the Board. In
order to ensure the Board maintains oversight of the default management
process, the default drills that include direct participation of the
Board members would be done at least on an annual basis.
    Finally, the Policy would describe governance, breach management
and exception handling, in a manner generally consistent with other ICE
Clear Europe policies. The document owner identified by the Clearing
House would be responsible for ensuring that the Policy remains up-to-
date and reviewed in accordance with the Clearing House's governance
processes. Document reviews would encompass at the minimum regulatory
compliance, documentation and purpose, implementation, use and open
items from previous validations or reviews. Results of the review would
have to be reported to the Executive Risk Committee or in certain cases
to the Model Oversight Committee. The document owner would also aim to
remediate the findings, complete internal governance and receive
regulatory approvals before the following annual review is due. The
document owner would also be responsible for reporting any material
breaches or deviations to the Head of Department, Chief Risk Officer
and Head of Regulation and Compliance in order to determine the
appropriate governance escalation and notification requirements.
Exceptions to the Policy would also be approved in accordance with such
governance processes.
    The Policy would also recognize that the management of any
particular default will depend on factors and circumstances that may be
difficult to predict. As a result, the President would be allowed to
override elements of the Policy to declare and manage an Event of
Default in accordance with the provisions of the Rules.
(b) Statutory Basis
    ICE Clear Europe believes that the Policy is consistent with the
requirements of Section 17A of the Securities Exchange Act of 1934
(``Act'') \6\ and the regulations thereunder applicable to it. In
particular, Section 17A(b)(3)(F) of the Act \7\ requires, among other
things, that the rules of a clearing agency be designed to promote the
prompt and accurate clearance and settlement of securities transactions
and, to the extent applicable, derivative agreements, contracts, and
transactions, the safeguarding of securities and funds in the custody
or control of the clearing agency or for which it is responsible, and
the protection of investors and the public interest.
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    \6\ 15 U.S.C. 78q-1.
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
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    The Policy is designed to set out the objectives and overall
practices and processes of the Clearing House in declaring and managing
an Event of Default, recognizing that the details of any particular
default will vary. The new Policy would more clearly set out the
responsibilities of the President and DMC in declaring and managing a
default. The Policy would also outline various aspects of the default
management process, including communications, hedging, client porting
and liquidation. The Policy would also address default testing, and the
Clearing House's multi-year testing plan to address various scenarios
and aspects of the default management process. In ICE Clear Europe's
view, the Policy will thus facilitate management of the risks related
to a default or anticipated default from a Clearing Member, so that the
Clearing House can promptly restore a matched book and contain losses.
The new Policy will thus promote the prompt and accurate clearing and
settlement of cleared transactions and is consistent with the
protection of investors and the public interest in the continued
operation of the Clearing House in the event of a Clearing Member
default. (ICE Clear Europe would not expect the adoption of the Policy
to materially affect the safeguarding of securities and funds in ICE
Clear Europe's custody or control or for which it is responsible.)
Accordingly, the Policy satisfies the requirements of Section
17A(b)(3)(F).\8\
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    \8\ 15 U.S.C. 78q-1(b)(3)(F).
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    The Policy is also consistent with relevant provisions of Rule
17Ad-22.\9\ Rule 17Ad-22(e)(2) provides that ``[e]ach covered clearing
agency shall establish, implement, maintain and enforce written
policies and procedures reasonably designed to, as applicable [. . .]
provide for governance arrangements that are clear and transparent''
\10\ and ``[s]pecify clear and direct lines of responsibility.\11\ As
discussed, the Policy would clearly state certain responsibilities of
the President, Board, DMC, and Executive Risk Committee, among others,
in relation to oversight of the Clearing House's declaration and
management of an Event of Default. Specifically, and consistent with
current practice, the President would have full authority in declaring
and managing an Event of Default, with the ability to delegate if
necessary or for the DMC to assume certain responsibilities if the
President is unavailable. In line with the Clearing House's other
policies and procedures, the Policy would also describe the
responsibilities of the document owner and appropriate escalation and
notification requirements for responding to exceptions and deviations
from the Policy. In ICE Clear Europe's view, the Policy is therefore
consistent with the requirements of Rule 17Ad-22(e)(2).\12\
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    \9\ 17 CFR 240.17 Ad-22.
    \10\ 17 CFR 240.17 Ad-22(e)(2)(i).
    \11\ 17 CFR 240.17 Ad-22(e)(2)(v).
    \12\ 17 CFR 240.17 Ad-22(e)(2).
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    Rule 17A-22(e)(13) [sic] provides that the ``covered clearing
agency shall establish, implement, maintain and enforce written
policies and procedures reasonably designed to, as applicable [. . .]
ensure that [sic] the covered clearing agency has the authority and
operational capacity to take timely action to contain losses and
liquidity demands and continue to meet its obligations by, at a
minimum, requiring the covered clearing agency's participants and,
where [sic] practicable, other stakeholders to participate [sic] the
testing and review of its default procedures, including any close-out
procedures, at least annually and following material changes thereto.''
\13\ As discussed above, the Policy would address the Clearing House's
procedures for testing its default management framework, which includes
annual default tests in which participation by Clearing Members is
mandatory, and further provides for additional testing in the event of
material changes in the default management process. The new Policy
would outline the Clearing House's overall multi-year testing plan and
address key scenarios and considerations to be included in the default
testing process. In ICE Clear Europe's views, these testing procedures,
together with the other aspects of the Policy and the underlying Rules,
will facilitate its ability to take timely action to contain losses and
liquidity pressure in the event of a Clearing Member default. As such,
the Policy is consistent with the requirements of Rule 17Ad-
22(e)(13).\14\
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    \13\ 17 CFR 240.17Ad-22(e)(13).
    \14\ 17 CFR 240.17Ad-22(e)(16). [sic]

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(B) Clearing Agency's Statement on Burden on Competition

    ICE Clear Europe does not believe the Policy would have any impact,
or impose any burden, on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Policy is being adopted to
document the Clearing House's practices relating to declaring and
managing an Event of Default of a Clearing Member. The Policy does not
change the rights or obligations of Clearing Members or the Clearing
House under the Rules or Procedures. The Policy does set out certain
requirements for Clearing Members to participate in annual default
testing (reflecting current practice), but the Clearing House does not
believe this requirement would impose a material burden on Clearing
Members (and in any event such participation is required of all
Clearing Members under Commission regulations as set out above).
Accordingly, ICE Clear Europe does not believe that adoption of the
Policy would adversely affect competition among Clearing Members,
materially affect the costs of clearing, adversely affect the ability
of market participants to access clearing or the market for clearing
services generally, or otherwise adversely affect competition in
clearing services. Therefore, ICE Clear Europe does not believe the
proposed rule change imposes any burden on competition that is not
necessary or appropriate in furtherance of the purposes of the Act.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments relating to the proposed amendment has not been
solicited or received by ICE Clear Europe. ICE Clear Europe will notify
the Commission of any comments received with respect to the proposed
rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \15\ and paragraph (f) of Rule 19b-4 \16\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
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    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml) or
     Send an email to [email protected]. Please include
File Number SR-ICEEU-2023-012 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-ICEEU-2023-012. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change, security-
based swap submission or advance notice that are filed with the
Commission, and all written communications relating to the proposed
rule change, security-based swap submission or advance notice between
the Commission and any person, other than those that may be withheld
from the public in accordance with the provisions of 5 U.S.C. 552, will
be available for website viewing and printing in the Commission's
Public Reference Room, 100 F Street NE, Washington, DC 20549, on
official business days between the hours of 10:00 a.m. and 3:00 p.m.
Copies of such filings will also be available for inspection and
copying at the principal office of ICE Clear Europe and on ICE Clear
Europe's website at https://www.theice.com/notices/Notices.shtml?regulatoryFilings.
    Do not include personal identifiable information in submissions;
you should submit only information that you wish to make available
publicly. We may redact in part or withhold entirely from publication
submitted material that is obscene or subject to copyright protection.
All submissions should refer to File Number SR-ICEEU-2023-012 and
should be submitted on or before May 23, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-09207 Filed 5-1-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44804-44805]
[FR Doc No: 2014-18198]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0967]

Intent To Exempt Certain Class II and Class I Reserved Medical
Devices From Premarket Notification Requirements; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Intent to Exempt Certain
Class II and Class I Reserved Medical Devices from Premarket
Notification Requirements.'' This draft guidance describes FDA's intent
to exempt certain Class II medical devices and certain Class I medical
devices, subject to the reserved criteria, from premarket notification
requirements. FDA believes devices identified in this guidance document
are sufficiently well understood and do not present risks that require
premarket notification review to assure their safety and effectiveness.
This draft guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 30, 2014.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Intent to Exempt Certain Class II and Class I Reserved Medical
Devices from Premarket Notification Requirements'' to the Office of the
Center Director, Guidance and Policy Development, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Abiy Desta, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1682, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the commitment letter (section 1.G of the Performance Goals and
Procedures) that was drafted as part of the reauthorization process for
the Medical Device User Fee Amendments of 2012 (Pub. L. 112-144), FDA
committed to identifying low-risk medical devices to exempt from
premarket notification. This draft guidance describes FDA's intent to
exempt certain Class II medical devices and certain Class I medical
devices that are subject to the reserved criteria of section 510(l) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) from
premarket submission requirements. FDA believes devices identified in
this guidance document are sufficiently well understood and do not
present risks that require 510(k) review.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on identifying
low risk medical devices to exempt from premarket notification. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statute
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Intent to Exempt Certain Class II and Class I Reserved Medical
Devices from Premarket Notification Requirements,'' you may send an
email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 1300046 to
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995

(44 U.S.C. 3501-3520). The collections of information in 21 CFR part
807, subpart E, have been approved under OMB control number 0910-0120.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18198 Filed 7-31-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 15, 2006 (Volume 71, Number 93)]
[Notices]
[Page 28057]
[DOCID:fr15my06-76]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

Federal Register  Citation of Previous Announcement: [71 FR 27014, May
9, 2006].

STATUS: Closed meeting.

PLACE: 100 F Street, NE., Washington, DC.

DATE AND TIME OF PREVIOUSLY ANNOUNCED MEETING: Thursday, May 11, 2006
at 1 p.m.

Change in the Meeting: Additional items.
    The following items will also be considered during the 1 p.m.
Closed Meeting scheduled for Thursday, May 11, 2006: Litigation
matters; regulatory matters involving financial institutions; other
matters related to enforcement proceedings; and an adjudicatory matter.
    Commissioner Glassman, as duty officer, determined that no earlier
notice thereof was possible.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items. For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact the Office of the Secretary at<PHONE_NUMBER>.

    Dated: May 10, 2006.
J. Lynn Taylor,
Assistant Secretary.
[FR Doc. 06-4585 Filed 5-11-06; 3:55 pm]

BILLING CODE 8010-01-P


[Federal Register: October 31, 2007 (Volume 72, Number 210)]
[Rules and Regulations]
[Page 61512-61513]
[DOCID:fr31oc07-5]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 748

[Docket No. 070817469-7596-01]
RIN 0694-AE11

Approved End-Users and Respective Eligible Items for the People's
Republic of China (PRC) Under Authorization Validated End-User (VEU);
Correction

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: The Bureau of Industry and Security (BIS) amended the Export
Administration Regulations (EAR) to list names of end-users in the
People's Republic of China (PRC) approved to receive exports, reexports
and transfers of certain items under Authorization Validated End-User
(VEU). The rule identified five specific validated end-users. This
final rule amends the EAR to correct an inadvertent omission in the
list of items approved for one of those validated end-users.

DATES: This rule is effective October 31, 2007. Although there is no
formal comment period, public comments on this regulation are welcome
on a continuing basis.

ADDRESSES: You may submit comments, identified by RIN 0694-AE11 (VEU),
by any of the following methods:
    E-mail<EMAIL_ADDRESS>Include ``RIN 0694-AE11 (VEU)''
in the subject line of the message.
    Fax:<PHONE_NUMBER>. Please alert the Regulatory Policy Division,
by calling<PHONE_NUMBER>, if you are faxing comments.
    Mail or Hand Delivery/Courier: Sheila Quarterman, U.S. Department
of Commerce, Bureau of Industry and Security, Regulatory Policy
Division, 14th St. & Pennsylvania Avenue, NW., Room 2705, Washington,
DC 20230, Attn: RIN 0694-AE11 (VEU).
    Send comments regarding the collection of information associated
with this rule, including suggestions for reducing the burden, to David
Rostker, Office of Management and Budget (OMB), by e-mail to
<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>; and to the Regulatory

Policy Division, Bureau of Industry and Security, Department of
Commerce, P.O. Box 273, Washington, DC 20044. Comments on this
collection of information should be submitted separately from comments
on the final rule (i.e. RIN 0694-AE11 (VEU))--all comments on the
latter should be submitted by one of the three methods outlined above.

FOR FURTHER INFORMATION CONTACT: Michael Rithmire, Chairman, End-User
Review Committee, Bureau of Industry and Security, Department of
Commerce, P.O. Box 273, Washington, DC 20044; by telephone (202) 482-
6105; or by e-mail to<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

Authorization Validated End-User (VEU): Initial List of Approved End-
Users, Eligible Items and Destinations: Correction of the List of
Eligible Items

    Created in a final rule on June 19, 2007 (72 FR 33646),
Authorization Validated End-User (VEU) is for approved end-users
located in eligible destinations to which eligible items (commodities,
software and technology, except those controlled for missile technology
or crime control reasons) may be exported, reexported or transferred
without a license, in conformance with Section 748.15 of the EAR. As
established in the June 19 rule, the PRC is the initial destination
eligible for exports, reexports and transfers under Authorization VEU.
    Authorization VEU is a mechanism to facilitate increased high-
technology exports to companies in the PRC that have a record of using
such items responsibly. VEUs will be able to obtain eligible items that
are on the Commerce Control List without having to wait for their
suppliers to obtain export licenses from BIS. A wide range of items are
eligible for Authorization VEU. In addition, Authorization VEU may be
used by foreign reexporters, and does not have an expiration date.
    BIS amended Supplement No. 7 to Part 748 of the EAR to identify
five companies with 14 eligible facilities in the PRC as VEUs and to
identify the items that may be exported, reexported, or transferred to
them in a final rule published in the Federal Register on Friday,
October 19, 2007 (72 FR 59164). Also see a related Federal Register
publication on Wednesday, October 24, 2007 (72 FR 60408). The VEUs
listed in Supplement No. 7 to Part 748 were reviewed and approved by
the U.S. Government in accordance with the provisions of Section 748.15
and Supplement Nos. 8 and 9 to Part 748 of the EAR. The October 19th
rule should have listed items controlled under Export Control
Classification Numbers (ECCNs) 3A001.a.5.a.5. and 3A001.a.5.b. in the
``Eligible Items (By ECCN)'' column of Supplement No. 7 to Part 748 of
the EAR for validated end-user National Semiconductor Corporation in
the PRC. This final rule amends the EAR to correct that inadvertent
omission in the list of items in Supplement No. 7 to Part 748 of the
EAR approved for National Semiconductor Corporation in the PRC.
    Since August 21, 2001, the Export Administration Act has been in
lapse and the President, through Executive Order 13222 of August 17,
2001 (3 CFR, 2001 Comp, p. 783 (2002)), as extended

most recently by the Notice of August 15, 2007 (72 FR 46137, August 16,
2007), has continued the EAR in effect under the International
Emergency Economic Powers Act. BIS continues to carry out the
provisions of the Act, as appropriate and to the extent permitted by
law, pursuant to Executive Order 13222.

Rulemaking

    1. This final rule has been determined to be not significant for
purposes of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to nor be subject to a penalty for failure to
comply with a collection of information, subject to the requirements of
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA),
unless that collection of information displays a currently valid Office
of Management and Budget (OMB) Control Number. This regulation involves
collections previously approved by the OMB under control number 0694-
0088, ``Multi-Purpose Application'', which carries a burden hour
estimate of 58 minutes to prepare and submit form BIS-748; and for
recordkeeping, reporting and review requirements in connection with
Authorization Validated End-User, which carries an estimated burden of
30 minutes per submission. This rule is expected to result in a
decrease in license applications submitted to BIS. Total burden hours
associated with the Paperwork Reduction Act and Office and Management
and Budget control number 0694-0088 are not expected to increase
significantly as a result of this rule.
    3. This rule does not contain policies with Federalism implications
as that term is defined under Executive Order 13132.
    4. The provisions of the Administrative Procedure Act requiring
notice of proposed rulemaking, the opportunity for public
participation, and a delay in effective date, are inapplicable because
this regulation involves a military and foreign affairs function of the
United States (5 U.S.C. 553(a)(1)). Further, no other law requires that
a notice of proposed rulemaking and an opportunity for public comment
be given for this final rule. Because a notice of proposed rulemaking
and an opportunity for public comment are not required to be given for
this rule under the Administrative Procedure Act or by any other law,
the analytical requirements of the Regulatory Flexibility Act (5 U.S.C.
601 et seq.) are not applicable. Therefore, this regulation is issued
in final form. Although there is no formal comment period, public
comments on this regulation are welcome on a continuing basis. Comments
should be submitted to Sheila Quarterman, Regulatory Policy Division,
Bureau of Industry and Security, Department of Commerce, P.O. Box 273,
Washington, DC 20044.

List of Subjects

15 CFR Part 748

    Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.

0
Accordingly, part 748 of the Export Administration Regulations (15 CFR
parts 730-799) is amended as follows:

PART 748--[AMENDED]

0
1. The authority citation for 15 CFR part 748 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66
FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 3, 2006, 71 FR
44551 (August 7, 2006); Notice of August 15, 2007, 72 FR 46137
(August 16, 2007).

0
2. Supplement No. 7 to part 748 is amended to correct the entry for
National Semiconductor Corporation to read as follows:

Supplement No. 7 to Part 748--Authorization Validated End-User (VEU):
List of Validated End-Users, Respective Items Eligible for Export,
Reexport and Transfer, and Eligible Destinations

------------------------------------------------------------------------
                                  Eligible items (by       Eligible
       Validated end-user                ECCN)            destination
------------------------------------------------------------------------

                              * * * * * * *
National Semiconductor            3A001.a.5.a.1;      National
 Corporation.                      3A001.a.5.a.2;      Semiconductor
                                   3A001.a.5.a.3;      Hong Kong
                                   3A001.a.5.a.4;      Limited, Beijing
                                   3A001.a.5.a.5;      Representative
                                   3A001.a.5.b.        Office, Room 604,
                                                       CN Resources
                                                       Building, No. 8
                                                       Jianggumenbei A,
                                                       Beijing, China
                                                       100005.
                                                      National
                                                       Semiconductor
                                                       Hong Kong
                                                       Limited, Shanghai
                                                       Representative
                                                       Office, Room 903-
                                                       905 Central
                                                       Plaza, No. 227
                                                       Huangpi Road
                                                       North, Shanghai,
                                                       China 200003.
                                                      National
                                                       Semiconductor
                                                       Hong Kong
                                                       Limited, Shenzhen
                                                       Representative
                                                       Office, Room 1709
                                                       Di Wang
                                                       Commercial
                                                       Centre, Shung
                                                       Hing Square, 5002
                                                       Shenna Road East,
                                                       Shenzhen, China
                                                       518008.
------------------------------------------------------------------------

* * * * *

Eileen M. Albanese,
Director, Office of Exporter Services.
 [FR Doc. E7-21465 Filed 10-30-07; 8:45 am]

BILLING CODE 3510-33-P


[Federal Register Volume 76, Number 86 (Wednesday, May 4, 2011)]
[Rules and Regulations]
[Pages 25240-25246]
[FR Doc No: 2011-10706]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0771; FRL-8873-3]

Clothianidin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
clothianidin in or on mustard, seed. Bayer CropScience requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 4, 2011. Objections and
requests for hearings must be received on or before July 5, 2011, 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-2008-0771. All documents in the
docket are listed in the docket index available at http://www.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 (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Marianne Lewis, 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?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

C. Can I file an objection or hearing request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2008-0771 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 July 5, 2011.
    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-2008-0771, 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 Facility'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. Summary of Petitioned-For Tolerance

    In the Federal Register of June 23, 2010 (75 FR 35803) (FRL-8831-
3), 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
0F7712) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive,
Research Triangle Park, NC 27709. The petition requested that 40 CFR
180.586 be amended by establishing tolerances for residues of the
insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-
methyl-2-nitroguanidine, in or on mustard, seed at 0.01 parts per
million (ppm). That notice referenced a summary of the petition
prepared by Bayer CropScience, 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.
    Bayer CropScience requested tolerances for residues of clothianidin
to support mustard, seed treatment uses.

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 clothianidin. EPA's assessment of exposures and risks
associated with clothianidin 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.
    EPA considered the toxicity of clothianidin as well as several
metabolites and degradates in conducting this risk assessment.
Metabolites/degradates of concern in plants include parent and TMG for
leafy and root and tuber vegetables; parent-only for other crops; and
parent, TZNG and MNG for rotational crops. For livestock commodities,
the metabolites/degradates of concern include: Parent and TZU, TZG,
TZNG and ATMG-pyruvate for ruminants; and parent and TZU, TZG, TZNG,
and ATG-acetate for poultry. Acute toxicity and genotoxicity data are
available for several metabolites/degradates of clothianidin. Given
that the points of departure (POD) used for risk assessment are well
below the LD50 levels observed in the acute toxicology
studies and that clothianidin and its metabolites/degradates of
toxicological concern are similar in structure, EPA is assuming that
these compounds are toxicologically equivalent to clothianidin with
respect to the endpoints being used for risk assessment.
    Clothianidin and its metabolites and degradates have relatively low
acute toxicity via oral, dermal and inhalation routes of exposure;
however, acute oral administration of clothianidin in mouse and the TMG
metabolite in rat showed evidence of increased relative toxicity. There
is no evidence of dermal sensitization or eye irritation with the
exception of the clothianidin-triazan intermediate, which is a dermal
sensitizer. The available data indicate that there are no consistent
target organs in mammals; however, some effects noted in the liver,
hematopoietic system and kidney are similar to effects from other
neonicotinoid insecticides.
    In subchronic oral studies, the dog seemed to be more sensitive to
clothianidin than the rat. In addition to decreases in body weight and
body weight gains observed in both animals, dogs also displayed
decreased white blood cells, albumin and total protein, as well as some
anemia. Long-term dietary administration of clothianidin did not result
in a wider spectrum of effects in the dog; in contrast, the chronic
feeding studies in rats showed additional effects in the liver, ovaries
and kidneys. In the mouse chronic oral study, increases in vocalization
and decreases in body weight and body weight gain were noted.
    Based on the lack of significant tumor increases in two adequate
rodent carcinogenicity studies, EPA has classified clothianidin as
``not likely to be carcinogenic to humans.'' A bone marrow micronucleus
assay in mice showed that clothianidin is neither clastogenic nor
aneugenic up to a toxic oral dose. Additionally, a study on the livers
of Wistar male mice showed no induction of unscheduled DNA sysnthesis
up to the limit dose; therefore, mutagenicity is not of concern.
    Clinical signs of neurotoxicity were exhibited in both rats
(decreased arousal, motor activity and locomotor activity) and mice
(decreased spontaneous motor activity, tremors and deep respirations)
in acute neurotoxicity studies following exposure by gavage; however,
no indications of neurotoxicity were observed following dietary
exposure in the subchronic neurotoxicity study in rats.
    There was no evidence of increased quantitative or qualitative
susceptibility of rat or rabbit fetuses following in utero exposure to
clothianidin in developmental studies; however, increased quantitative
susceptibility of rat pups was seen in both the reproduction and
developmental neurotoxicity studies. In the rat reproduction study,
offspring toxicity (decreased body weight gains and absolute thymus
weights in pups, delayed sexual maturation and an increase in
stillbirths) was observed in the absence of maternal effects. In the
developmental neurotoxicity study in rats, offspring effects (decreased
body

weights, body weight gains, motor activity and acoustic startle
response amplitude) were noted at doses lower than those resulting in
maternal toxicity.
    Decreased absolute and relative thymus and spleen weights were
observed in multiple studies; these studies showed possible evidence of
effects on the immune system. In addition, juvenile rats in the rat
reproduction study appeared to be more susceptible to these effects.
However, a guideline immunotoxicity study showed no evidence of
clothianidin-mediated immunotoxicity in adult rats and a developmental
immunotoxicity study demonstrated no increased susceptibility for
offspring with regard to immunotoxicity.
    Specific information on the studies received and the nature of the
adverse effects caused by clothianidin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Clothianidin: Human Health Risk
Assessment for Proposed Uses on Berries (Group 13-07H), Brassica
Vegetables (Group 5), Cotton, Cucurbit Vegetables (Group 9), Fig,
Fruiting Vegetables (Group 8), Leafy Green Vegetables (Group 4A),
Peach, Pomegranate, Soybean, Tree Nuts (Group 14), and Tuberous and
Corm Vegetables (Group 1C)'' in docket ID number EPA-HQ-OPP-2008-0945.

B. Toxicological Points of Departure/Levels of Concern

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

  Table--Summary of Toxicological Doses and Endpoints for Clothianidin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
         Exposure/scenario              uncertainty/safety   RfD, PAD, LOC for risk    Study and toxicological
                                             factors                assessment                 effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years   NOAEL = 25 milligrams/  Acute RfD = 0.25 mg/kg/ Rabbit developmental study.
 of age).                             kilograms/day (mg/kg/   day.                   LOAEL = 75 mg/kg/day based
                                      day).                  aPAD = 0.25mg/kg/day..   on increased litter
                                     UFA = 10x.............                           incidence of a missing
                                     UFH = 10x.............                           lobe of the lung.
                                     FQPA SF = 1x..........
Acute dietary (General population).  NOAEL = 25 mg/kg/day..  Acute RfD = 0.25 mg/kg/ Special neurotoxicity/
                                     UFA = 10x.............   day.                    pharmacological study in
                                     UFH = 10x.............  aPAD = 0.25 mg/kg/day.   mice.
                                     FQPA SF = 1x..........                          LOAEL = 50 mg/kg/day based
                                                                                on transient signs of
                                                                                decreased spontaneous
                                                                                motor activity, tremors
                                                                                and deep respirations.
Chronic dietary (All populations     NOAEL= 9.8 mg/kg/day..  Chronic RfD = 0.098 mg/ 2-Generation reproduction
 including infants and children).    UFA = 10x.............   kg/day.                 study.
                                     UFH = 10x.............  cPAD = 0.098 mg/kg/     LOAEL = 31.2 mg/kg/day
                                     FQPA SF = 1x..........   day..                   based on decreased body
                                                                                weight gains and delayed
                                                                                sexual maturation,
                                                                                decreased absolute thymus
                                                                                weights in F1 pups and
                                                                                increased stillbirths in
                                                                                both generations.
Incidental oral (Short and           NOAEL= 9.8 mg/kg/day..  LOC for MOE = 100.....  2-Generation reproduction
 intermediate term).                 UFA = 10x.............                           study.
                                     UFH = 10x.............                          LOAEL = 31.2 mg/kg/day
                                     FQPA SF = 1x..........                           based on decreased body
                                                                                weight gains and delayed
                                                                                sexual maturation,
                                                                                decreased absolute thymus
                                                                                weights in F1 pups and
                                                                                increased stillbirths in
                                                                                both generations.
Dermal (All durations).............  Oral study NOAEL = 9.8  LOC for MOE = 100.....  2-Generation reproduction
                                      mg/kg/day (dermal                               study.
                                      absorption rate = 1%.                          LOAEL = 31.2 mg/kg/day
                                     UFA = 10x.............                           based on decreased body
                                     UFH = 10x.............                           weight gains and delayed
                                     FQPA SF = 1x..........                           sexual maturation,
                                                                                decreased absolute thymus
                                                                                weights in F1 pups and
                                                                                increased stillbirths in
                                                                                both generations.
Inhalation (All durations).........  Oral study NOAEL= 9.8   LOC for MOE = 100.....  2-Generation reproduction
                                      mg/kg/day (inhalation                           study.
                                      absorption rate =                              LOAEL = 31.2 mg/kg/day
                                      100%).                                          based on decreased body
                                     UFA = 10x.............                           weight gains and delayed
                                     UFH = 10x.............                           sexual maturation,
                                     FQPA SF = 1x..........                           decreased absolute thymus
                                                                                weights in F1 pups and
                                                                                increased stillbirths in
                                                                                both generations.
                                    ----------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..                  ``Not likely to be Carcinogenic to Humans''
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of
  concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to clothianidin, EPA considered exposure from the petitioned-
for tolerances as well as all existing clothianidin tolerances in 40
CFR 180.586. EPA assessed dietary exposures from clothianidin in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for clothianidin. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food from use of clothianidin, EPA used maximum field trial
values, empirical processing factors and assumed 100 percent crop
treated (PCT) for all commodities. Clothianidin is a major metabolite
of thiamethoxam, and there are a number of crops for which uses of both
clothianidin and thiamethoxam have been registered. The labels for the
various end-use products containing these active ingredients prohibit
the application of both active ingredients to the same crop during a
growing cycle. Due to that restriction and the assumption of 100 PCT, a
single value reflecting the greatest clothianidin residue from either
active ingredient has been used for crops listed for use with both
active ingredients (versus combined estimates from clothianidin and
from thiamethoxam). Generally, this assessment uses the established or
recommended clothianidin tolerance for crops having tolerances for both
compounds (the exception being low-growing berry, subgroup 13-07G,
which is based on observed clothianidin residues in thiamethoxam
strawberry field trials). For foods with thiamethoxam tolerances but
without clothianidin tolerances, maximum residues of clothianidin
observed in thiamethoxam field trials have been used in these
assessments. These include meats, meat by-products, artichoke, tropical
fruits, coffee, hop, mint, rice, and strawberry. The metabolism of
clothianidin is complex, with a few major (> 10% of the total
radioactive residues) and numerous minor metabolites. Metabolites/
degradates of concern in plants include clothianidin and TMG for leafy
and root and tuber vegetables; parent-only for other crops; and parent,
TZNG and MNG for rotational crops. For livestock commodities, the
metabolites of concern include: Parent and TZU, TZG, TZNG, and ATMG-
pyruvate for ruminants; and parent and TZU, TZG, TZNG, and ATG-acetate
for poultry. For leafy vegetables the EPA required analysis for
residues of TMG along with parent in field trial samples. Residues of
TMG were shown to occur in leafy vegetables at levels approximately 10-
fold below those of clothianidin. EPA has not included these
metabolites in the tolerance expression for plant or animal commodities
because the metabolites are only found in certain commodities,
including the metabolites would create tolerance harmonization issues
with Canada, and monitoring residues of clothianidin based on parent
only would be representative of total clothianidin residues and thus
adequate for enforcement. Because the metabolites are not included in
the tolerance expressions, an adjustment factor of 1.1 has been
incorporated into the assessment for leafy vegetables to account for
the presence of the metabolite TMG, and an adjustment factor of 1.5 has
been incorporated for livestock-derived commodities (milk) to account
for the presence of metabolites TZU, TZG, TZNG, ATMG-pyruvate and ATG-
acetate. The 1.1 adjustment factor is based on field trial data showing
TMG does not exceed 10% of the parent compound residue level in leafy
vegetables and the 1.5 factor was based on metabolism data.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assessed chronic
dietary exposure using the same residue information and assumptions
regarding metabolites/degradates as in the acute exposure analysis.
    iii. Cancer. Based on the lack of evidence of carcinogenicity in
two adequate rodent carcinogenicity studies, EPA has classified
clothianidin as ``not likely to be carcinogenic to humans.'' Therefore,
a quantitative exposure assessment to evaluate cancer risk is
unnecessary.
    iv. Anticipated residue and PCT information. For food with
thiamethoxam tolerances but without colothianidin tolerances, maximum
residues of clothianidin observed in thiamethoxam field trials have
been used in these assessments. For all commodities, 100 PCT was
assumed.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for clothianidin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of clothianidin. 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 First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of clothianidin for
surface water are estimated to be 7.29 parts per billion (ppb) for
acute exposures and 1.35 ppb for chronic exposures. For ground water,
the EDWC is estimated to be 5.88 ppb.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. The water concentration value
of 7.29 ppb was used to assess the contribution to drinking water for
the acute dietary assessment. For chronic dietary risk assessment, the
water concentration value of 5.88 ppb was used.
    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).
    Clothianidin is currently registered for use on turf. Residential
handler exposure is not expected from the currently registered or
proposed uses of clothianidin since these products are to be applied by
commercial applicators. Adult short- and intermediate-term
postapplication exposures were assessed for dermal exposures from
commercial applications (via granular push-type spreaders), dermal
post-application contact and golfer postapplication contact. For
toddlers, short- and intermediate-term postapplication incidental oral
(hand-to-mouth and soil ingestion) and dermal risks were assessed for
exposure to treated turf.
    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.''
    Clothianidin is a member of the neonicotinoid class of pesticides
and is

a metabolite of another neonicotinoid, thiamethoxam. 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 nAChRs, 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 clothianidin is based on unrelated
effects in mammals, including changes in body and thymus weights,
delays in sexual maturation, and still births. Additionally, the most
sensitive toxicological effect in mammals differs across the
neonicotinoids (such as testicular tubular atrophy with thiamethoxam,
and mineralized particles in thyroid colloid with imidaclopid). 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 the policy statements
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism
released by OPP on EPA's Web site at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no indication of
increased quantitative or qualitative susceptibility, as compared to
adults, of rat and rabbit fetuses following in utero exposure to
clothianidin in developmental studies. However, increased quantitative
susceptibility was observed in both the developmental neurotoxicity and
rat multi-generation reproduction studies. In the developmental
neurotoxicity study, offspring toxicity (decreased body weight gains,
motor activity and acoustic startle response) was seen at a lower dose
than that which caused maternal toxicity. In the 2-generation rat
reproduction study, offspring toxicity (decreased body weight gains,
delayed sexual maturation in males, decreased absolute thymus weights
in F1 pups of both sexes and an increase in stillbirths in both
generations) was seen at a dose lower than that which caused parental
toxicity.
    3. Conclusion. In the final rule published in the Federal Register
of February 6, 2008 (73 FR 6851) (FRL-8346-9), EPA had previously
determined that the FQPA SF for clothianidin should be retained at 10X
because EPA had required the submission of a developmental
immunotoxicity study to address the combination of evidence of
decreased absolute and adjusted organ weights of the thymus and spleen
in multiple studies in the clothianidin data base, and evidence showing
that juvenile rats in the 2-generation reproduction study appear to be
more susceptible to these potential immunotoxic effects. In the absence
of a developmental immunotoxicity study EPA concluded that there was
sufficient uncertainty regarding immunotoxic effects in the young that
the 10X FQPA factor should be retained as a database uncertainty
factor. Since that determination, EPA has received and reviewed an
acceptable/guideline developmental immunotoxicity study, which
demonstrated no treatment-related effects. Taking the results of this
study into account as well as the rest of the data on clothianidin, EPA
has determined that reliable data show the safety of infants and
children would be adequately protected if the FQPA SF for clothianidin
were reduced to 1X. That decision is based on the following findings:
    i. The toxicity database for clothianidin is complete. As noted,
the prior data gap concerning developmental immunotoxicity has been
addressed by the submission of an acceptable developmental
immunotoxicity study.
    ii. A rat developmental neurotoxicity study is available and shows
evidence of increased quantitative susceptibility of offspring.
However, EPA considers the degree of concern for the developmental
neurotoxicity study to be low for pre- and postnatal toxicity because
the NOAEL and LOAEL were well characterized, and the doses and
endpoints selected for risk assessment are protective of the observed
susceptibility; therefore, there are no residual concerns regarding
effects in the young.
    iii. While the rat multi-generation reproduction study showed
evidence of increased quantitative susceptibility of offspring compared
to adults, the degree of concern is low because the study NOAEL and
LOAEL have been selected for risk assessment purposes for relevant
exposure routes and durations. In addition, the potential immunotoxic
effects observed in the study have been further characterized with the
submission of a developmental immunotoxicity study that showed no
evidence of susceptibility. As a result, there are no concerns or
residual uncertainties for pre- and postnatal toxicity after
establishing toxicity endpoints and traditional UFs to be used in the
risk assessment for clothianidin.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on assumptions that were judged to be highly conservative and health-
protective for all durations and population subgroups, including
maximum field trial residues, adjustment factors from metabolite data,
empirical processing factors, and 100 PCT for all commodities.
Additionally, EPA made conservative (protective) assumptions in the
ground and surface water modeling used to assess exposure to
clothianidin in drinking water. EPA

used similarly conservative assumptions to assess postapplication
exposure of children and adults as well as incidental oral exposure of
toddlers. These assessments will not underestimate the exposure and
risks posed by clothianidin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
aPAD and cPAD. 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 appropriate POD to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to clothianidin will occupy 23% of the aPAD for children 1-2 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 chronic exposure to
clothianidin from food and water will utilize 19% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
clothianidin is not expected.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Clothianidin is currently registered for use on turf that could
result in short- and intermediate-term residential exposure and the
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with short- and intermediate-term
residential exposures to clothianidin. Using the exposure assumptions
described in this unit for short- and intermediate-term exposures, EPA
has concluded the combined short- and intermediate-term food, water,
and residential exposures result in aggregate MOEs of greater than 380
for all population subgroups. As the aggregate MOEs are greater than
100 (the LOC) for all population subgroups, including infants and
children, short- and intermediate-term aggregate exposures to
clothianidin are not of concern to EPA.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in mice and rats at doses that were judged
to be adequate to assess the carcinogenic potential, clothianidin was
classified as ``not likely to be carcinogenic to humans,'' and is not
expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to clothianidin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the
tolerance expression. This method involves extraction of residues with
acetonitrile/water, cleanup using solid phase extraction (SPE)
cartridges, and analysis of clothianidin by liquid chromatography/mass
spectrometry/mass spectrometry (LC/MS/MS). The method may be requested
from: Chief, Analytical Chemistry Branch, Environmental Science Center,
701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-
2905; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

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

C. Revisions to Petitioned-For Tolerances

    The tolerance is considered appropriate as proposed; therefore, no
revisions were needed.

V. Conclusion

    Therefore, tolerances are established for residues of clothianidin,
(E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in
or on mustard, seed at 0.01 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, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under 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) (Pub. L. 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 26, 2011.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.586 is amended by alphabetically adding ``Mustard,
seed'' to the table in paragraph (a)(1) to read as follows:

Sec.  180.586  Clothianidin; tolerances for residues.

    (a) * * *
    (1) * * *

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

                                * * * * *
Mustard, seed..............................................         0.01

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

* * * * *
[FR Doc. 2011-10706 Filed 5-3-11; 8:45 am]
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[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Proposed Rules]
[Pages 69602-69603]
[FR Doc No: 2013-27645]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2011-N-0143]
RIN 0910-AG64

Foreign Supplier Verification Programs for Importers of Food for
Humans and Animals; Extension of Comment Periods

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period for the proposed
rule and for its information collection provisions.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for the proposed rule, and for the information
collection related to the proposed rule entitled ``Foreign Supplier
Verification Programs for Importers of Food for Humans and Animals''
that appeared in the Federal Register of July 29, 2013. We are taking
this action in response to requests for an extension to allow
interested persons an opportunity to consider the interrelationship
between this proposed rule and the proposed rule announced in October
2013 entitled ``Current Good Manufacturing Practice and Hazard Analysis
and Risk-Based Preventive Controls for Food for Animals.'' We also are
taking this action to keep the comment period for the information
collection provisions associated with the rule consistent with the
comment period for the proposed rule.

DATES: For the proposed rule published on July 29, 2013 (78 FR 45730),
submit either electronic or written comments by January 27, 2014.
Submit comments on information collection issues under the Paperwork
Reduction Act of 1995 (the PRA) by January 27, 2014 (see the
``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0143 and/or Regulatory Information Number (RIN) 0910-AG64, by any of
the following methods, except that comments on information collection
issues under the PRA must be submitted to the Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB) (see the
``Paperwork Reduction Act of 1995'' section of this document).

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency
name, Docket No. FDA-2011-N-0143, and RIN 0910-AG64 for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Request for Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    With regard to the proposed rule: Brian Pendleton, Office of
Policy, Food and Drug Administration, 10903 New

Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    With regard to the information collection: Domini Bean, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400T, Rockville, MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 29, 2013 (78 FR 45730), we
published a proposed rule entitled ``Foreign Supplier Verification
Programs for Importers of Food for Humans and Animals'' with a 120-day
comment period on the provisions of the proposed rule and on the
information collection provisions that are subject to review by OMB
under the PRA (44 U.S.C. 3501-3520).
    FDA has received requests for an extension of the comment period on
the proposed rule to allow interested persons an opportunity to
consider the interrelationship between this proposed rule and the
proposed rule entitled ``Current Good Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive Controls for Food for Animals'' (78
FR 64736, October 29, 2013). FDA has considered the requests and is
granting a 60-day extension of the comment period for the ``Foreign
Supplier Verification Programs for Importers of Food for Humans and
Animals'' proposed rule to allow interested persons an opportunity to
consider the interrelationships between the proposed rules. We also are
extending the comment period for the information collection provisions
for 60 days to make the comment period for the information collection
provisions the same as the comment period for the provisions of the
proposed rule. To clarify, FDA is requesting comment on all issues
raised by the proposed rule.

II. Paperwork Reduction Act of 1995

    Interested persons may either submit electronic comments regarding
the information collection to<EMAIL_ADDRESS>or fax
written comments to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>. All comments should be
identified with the title ``Foreign Supplier Verification Programs for
Importers of Food for Humans and Animals.''

III. Request for Comments

    Interested persons may submit either electronic comments regarding
the proposed rule to http://www.regulations.gov or written comments to
the Division of Dockets Management (see ADDRESSES). It is only
necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.

    Dated: November 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27645 Filed 11-19-13; 8:45 am]
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