[Federal Register: September 23, 2010 (Volume 75, Number 184)]
[Rules and Regulations]
[Page 57847-57848]
[DOCID:fr23se10-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0429; Airspace Docket No. 10-ASO-24]

Establishment of Class E Airspace; Homestead, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E Airspace at Homestead, FL, to
accommodate the additional airspace needed for the Standard Instrument
Approach Procedures (SIAPs) developed for Homestead General Aviation
Airport. This action enhances the safety and airspace management of
Instrument Flight Rules (IFR) operations at the airport.

DATES: Effective 0901 UTC, November 18, 2010. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On May 11, 2010, the FAA published in the Federal Register a notice
of proposed rulemaking to establish Class E airspace at Homestead, FL
(75 FR 26148) Docket No. FAA-2010-0429. Interested parties were invited
to participate in this rulemaking effort by submitting written comments
on the proposal to the FAA. No comments were received. Class E airspace
designations are published in paragraph 6005 of FAA Order 7400.9U dated
August 18, 2010, and effective September 15, 2010, which is
incorporated by reference in 14 CFR 71.1. The Class E airspace
designations listed in this document will be published subsequently in
the Order.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 establishes the Class E airspace extending upward from 700 feet
above the surface at Homestead, FL, to provide controlled airspace
required to support the SIAPs developed for Homestead General Aviation
Airport. This action is necessary for the safety and management of IFR
operations at the airports.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes Class E airspace at Homestead, FL.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9U, Airspace Designations and Reporting
Points, dated August 18, 2010, effective September 15, 2010, is amended
as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ASO FL E5 Homestead, FL [NEW]

Homestead General Aviation Airport, FL
    (Lat. 25[deg]29'57'' N., long. 80[deg]33'15'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Homestead General Aviation Airport.

    Issued in College Park, Georgia, on September 15, 2010.
Myron A. Jenkins,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2010-23727 Filed 9-22-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 6, 2007 (Volume 72, Number 172)]
[Notices]
[Page 51270-51271]
[DOCID:fr06se07-100]

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

Submission for OMB Review; Comment Request

Upon written request; copies available from: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension: Regulation A; OMB Control No. 3235-0286; SEC File No.
270-110 (Forms 1-A and 2-A).

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.
    Regulation A (17 CFR 230.251 through 230.263) provides an exemption
from registration under the Securities Act of 1933 (15 U.S.C. 77a et
seq.) for certain limited securities offerings by issuers who do not
otherwise file reports with the Commission. Form 1-A is an offering
statement filed under Regulation A. Form 2-A is used to report sales
and use of proceeds in Regulation A offerings. All information is
provided to the public for review. The information required is filed on
occasion and is mandatory. We estimate approximately 100 issuers file
Forms 1-A and 2-A annually. We estimate that Form 1-A takes 608 hours
to prepare, Form 2-A takes 12 hours to prepare, and Regulation A takes
one administrative hour to review for a total of 621 hours per
response. We estimate that 75% of 621 hours per response (465.75 hours)
is prepared by the company for a total annual burden of 46,575 hours
(465.75 x 100 responses).
    An agency may conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid control number.
    Written comments regarding the above information should be directed
to the following persons: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or send an e-mail to
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief Information

Officer, Securities and Exchange Commission, C/O Shirley Martinson,
6432 General Green Way, Alexandria, VA 22312; or send an e-mail to:
<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days

of this notice.

     August 30, 2007.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-17574 Filed 9-5-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Page 52782]
[FR Doc No: 2022-18519]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0026]

Issuance of Priority Review Voucher; Rare Pediatric Disease
Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of a priority review voucher to the sponsor of a rare
pediatric disease product application. The Federal Food, Drug, and
Cosmetic Act (FD&C Act) authorizes FDA to award priority review
vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA is required to publish
notice of the award of the priority review voucher. FDA has determined
that ZYNTEGLO (betibeglogene autotemcel), manufactured by bluebird bio,
Inc., meets the criteria for a priority review voucher.

FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of an approved rare pediatric disease
product application. Under section 529 of the FD&C Act (21 U.S.C.
360ff), FDA will award priority review vouchers to sponsors of approved
rare pediatric disease product applications that meet certain criteria.
FDA has determined that ZYNTEGLO (betibeglogene autotemcel),
manufactured by bluebird bio, Inc., meets the criteria for a priority
review voucher. ZYNTEGLO is indicated for the treatment of adult and
pediatric patients with [szlig]-thalassemia who require regular red
blood cell transfusions.
    For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to https://www.fda.gov/industry/developing-products-rare-diseases-conditions/rare-pediatric-disease-rpd-designation-and-voucher-programs. For further information about
ZYNTEGLO, go to the Center for Biologics Evaluation and Research's
Approved Cellular and Gene Therapy Products website at https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products.

    Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18519 Filed 8-26-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 169 (Thursday, August 30, 2018)]
[Notices]
[Pages 44377-44381]
[FR Doc No: 2018-18784]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83940; File No. SR-DTC-2018-006]

Self-Regulatory Organizations; The Depository Trust Company;
Order Granting Approval of Proposed Rule Change To Amend Rule 35 To
Provide for Designated Accounts for Use With Designated Collateral
Management Service Providers

August 24, 2018.
    On July 9, 2018, The Depository Trust Company (``DTC'') filed with
the Securities and Exchange Commission (``Commission'') proposed rule
change SR-DTC-2018-006 pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder.\2\ The
proposed rule change was published for comment in the Federal Register
on July 24, 2018.\3\ The Commission did not receive any comment letters
on the proposed rule change. For the reasons discussed below, the
Commission approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No.83667 (July 18,
2018), 83 FR 35044 (July 24, 2018) (SR-DTC-2018-006) (``Notice'').
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I. Description of the Proposed Rule Change

    The proposed rule change would amend the Rules, By-Laws and
Organization Certificate of The Depository Trust Company (``DTC
Rules'') \4\ to revise DTC's current Rule 35--CMS Reporting (``Rule
35'').
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    \4\ Available at http://www.dtcc.com/legal/rules-and-procedures.aspx. Each capitalized term not otherwise defined herein
has its respective meaning as set forth in the DTC Rules.
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A. Background

    Currently, Rule 35 provides that a Participant of DTC
(``Participant'') may establish a collateral management service
(``CMS'') \5\ sub-account (``CMS Sub-Account''), which authorizes DTCC
Euroclear Global Collateral Ltd. (``DEGCL'') \6\ to receive from DTC
(i) a CMS report that provides information regarding securities
credited to the CMS Sub-Account of such Participant at the time of the
report (``CMS Report''), and (ii) CMS delivery information that
provides real-time information regarding any delivery or pledge from,
or delivery or release to, the CMS Sub-Account (``CMS Delivery
Information'').\7\
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    \5\ Collateral management generally involves calculating
collateral requirements and facilitating the transfer of collateral
between counterparties. See Securities Exchange Act Release No.
64796 (July 1, 2011), 76 FR 39963, 39964 (July 7, 2011) (S7-28-11).
    \6\ DEGCL is a joint venture of The Depository Trust & Clearing
Corporation, the corporate parent of DTC, and Euroclear S.A./N.V.
and was formed for the purpose of offering global information,
record keeping, and processing services for derivatives collateral
transactions and other types of financing transactions. DEGCL offers
service options for the selection of collateral to satisfy the
collateral obligations of its users (``DEGCL CMS''). See Securities
Exchange Act Release No. 80280 (March 20, 2017), 82 FR 15081 (March
24, 2017) (SR-DTC-2017-001) (``CMS Order'') (providing additional
information on DEGCL and DEGCL CMS). One option relates exclusively
to Securities held at DTC, and is dependent on Rule 35. Id.
    \7\ CMS Order, 82 FR at 21838.
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B. The Proposed Rule Change

    DTC proposes five changes to Rule 35: (1) Adding the term ``CMSP''
(i.e., a CMS provider) and its associated function; (2) adding the term
``CMSP Accounts'' and its associated function; (3) adding the term
``CMSP Reports'' and its associated function; (4) authorizing a CMSP to
submit CMSP instructions (``CMSP Instructions'') on behalf of a
Participant or a Pledgee of DTC (``Pledgee''); and (5) making
ministerial changes to conform with the proposed changes, as well as
making stylistic edits.\8\ Each of these proposed changes is described
below.
---------------------------------------------------------------------------

    \8\ Notice, 83 FR at 35044-45.
---------------------------------------------------------------------------

1. CMSP
    The proposal would add to Rule 35 the term and function of a CMSP,
which a Participant or Pledgee could then designate to act on its
behalf under the rule, pursuant to the proposed changes.\9\ The term
CMSP would replace the existing, singular designation of DEGCL to act
under Rule 35 as a collateral management provider.\10\ A partnership,
corporation, or other organization or entity could become a CMSP, under
the proposed changes to Rule 35, if it satisfies three proposed
criteria: (1) One or more Participants or Pledgees designate the entity
as a CMSP for purposes of Rule 35; (2) the entity (i) satisfies at
least one of the qualifications set forth in Section 1(a)-(h) of Rule 3
\11\ or (ii) is organized in a country other than the United States, is
regulated by a financial regulatory authority in the country in which
it is organized, and demonstrates that it has notified the Commission
in writing of its intention to operate under Rule 35; \12\ and (3) the
entity establishes a connection to DTC, in accordance with the
reasonable requirements of DTC, in order to be able to receive position
and transaction information and to submit instructions to DTC in
accordance with the DTC Rules and Procedures.\13\
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    \9\ Notice, 83 FR at 35045.
    \10\ Id.
    \11\ Sections 1(a)-(h) of Rule 3 provide the qualifications for
a partnership, corporation or other organization or entity to be
eligible to become a Participant. See DTC Rules, Rule 3, Sections
1(a)-(h), supra note 4.
    \12\ DTC states that in order to protect DTC, its Participants
and Pledgees, a CMSP that wishes to act under the proposed changes
to Rule 35 would need to be subject to regulatory oversight
comparable to a Participant, as provided in proposed Section 2(b)(i)
of Rule 35, or, if the entity is organized in a country other than
the United States (a ``non-U.S. entity''), it would need to be
regulated by a financial regulatory authority in the country in
which it is organized, as provided in proposed Section 2(b)(ii) of
Rule 35. Notice, 83 FR at 35045. Further, the proposed rule change
would require that, in order to be eligible to become a CMSP, the
non-U.S. entity must notify the Commission in writing of its
intention to operate under Rule 35, as modified by the proposed
changes. Id. While DTC reserves the right to request documentation
and/or information relating to a CMSP's compliance with the
requirements of proposed Section 2 of Rule 35, it would be the sole
responsibility of the Participant or Pledgee to evaluate and choose
an appropriate CMSP that, at a minimum, satisfies the requirements.
Id. Under proposed Section 2 of Rule 35, the designating Participant
or Pledgee would remain liable as principal for the actions of its
designated CMSP(s) on its behalf, and would indemnify DTC for any
loss, liability, or expense as a result of any claim arising from
(i) any act or omission of the CMSP, (ii) the provision of CMSP
Reports to the CMSP by DTC, or (iii) DTC's compliance with
instructions of the CMSP. Id.
    \13\ Id.
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    As proposed, DTC may decline to accept an entity as a CMSP if it
would present material risk to DTC, its Participants and Pledgees, or
impose material costs to DTC.\14\ DTC states that some examples of
circumstances in which DTC might reject an applicant as a CMSP include
when DTC reasonably believes that acceptance of the applicant as a CMSP
would (i) subject DTC to additional legal or regulatory regimes, to
which it is not otherwise subject; (ii) expose DTC to additional
technology risk; or (iii) cause DTC to be in violation of applicable
law or regulation.\15\
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    \14\ Id.
    \15\ Id.
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2. CMSP Account
    The proposed rule change would add the term and function of a
``CMSP Account'' to Rule 35.\16\ Currently, Rule 35 requires a
Participant looking to utilize the services offered through Rule 35 to
designate an account for such

purposes (i.e., a CMS Sub-Account).\17\ A Pledgee, however, is not
permitted to designate a CMS Sub-Account under the existing Rule 35.
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    \16\ Id.
    \17\ Id.
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    The proposed CMSP Account would replace the concept of the existing
CMS Sub-Account and would allow either a Participant or a Pledgee to
designate any account as a CMSP Account.\18\ Once established, a CMSP
Account would allow the designated CMSP access and authority to provide
instruction to DTC (as further described below) for the Delivery,
Pledge, or Release of securities on behalf of a Participant or Pledgee,
as applicable.\19\ As proposed, a Participant or Pledgee could
designate one or more CMSP Accounts and, concurrently, designate one or
more CMSPs with respect to each CMSP Account.\20\
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    \18\ Id.
    \19\ Id. The proposed rule change would specify that, with
respect to a CMSP Account, a Participant or Pledgee would retain the
right to instruct DTC as otherwise provided in the DTC Rules and
Procedures. Id.
    \20\ Id.
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    A Participant's or Pledgee's designation of a CMSP for a CMSP
Account would serve four functions: (1) The appointment of the CMSP to
act on its Participant's or Pledgee's behalf for the purposes of Rule
35; (2) the authorization of the CMSP to receive CMSP Reports and to
provide CMSP Instructions on behalf of its Participant or Pledgee; (3)
the authorization of DTC to act in accordance with any CMSP Instruction
of a Participant's or Pledgee's designated CMSP; and (4) the
representation and warranty of the Participant or Pledgee that it is
duly authorized to instruct DTC to provide CMSP Reports to the CMSP and
to act in accordance with any CMSP Instruction.\21\
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    \21\ Id.
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    The proposed rule change would not substantially alter the current
liability and indemnification provisions provided for in Rule 35.\22\
Specifically, the proposed rule change would provide that each
Participant and Pledgee that designates a CMSP would indemnify DTC, and
any nominee of DTC, against any loss, liability or expense as a result
of any claim arising from the compliance of DTC with CMSP Instructions,
except to the extent such loss, liability, or expense is caused
directly by the DTC's gross negligence or willful misconduct.\23\
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    \22\ Id.
    \23\ Id.
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3. CMSP Reports
    Rule 35 currently authorizes DEGCL, and only DEGCL, to receive
position and transaction information from DTC on behalf of a
Participant in the form of CMS Delivery Information and CMS
Reports.\24\ The proposed rule change would permit a Participant or
Pledgee to authorize a CMSP, which may or may not be DEGCL, to receive
CMSP Reports (with respect to CMSP Accounts for which the CMSP is
designated).\25\ The CMSP Information and CMSP Position Report are
analogous to the reports currently provided to DEGCL under Rule 35
(i.e., CMS Report and CMS Delivery Information, respectively).\26\
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    \24\ Id.
    \25\ Id.
    \26\ Id.
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    Currently, Rule 35 defines ``CMS Delivery Information'' to mean,
``with respect to CMS Securities and any Delivery or Pledge thereof
from, or Delivery or Release thereof to, a CMS Sub-Account, a copy of
any Delivery, Pledge, or Release message sent to the CMS Participant by
DTC, including the following information: (x) The CUSIP, ISIN, or other
identification number of such CMS Securities, and (y) the number of
shares or other units or principal amount of such CMS Securities.''
\27\ DTC states that this definition was drafted to align with DEGCL
specifications.\28\
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    \27\ Notice, 83 FR at 35046.
    \28\ Id.
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    Pursuant to the proposed rule change, the definition of ``CMSP
Information'' would be drafted in more general terms to provide
flexibility for the different collateral management service offerings
of CMSPs (in addition to DEGCL).\29\ Pursuant to the proposed rule
change, ``CMSP Information'' would mean, ``with respect to a CMSP
Account of a Participant or Pledgee, a copy of any message sent to the
Participant or Pledgee by the Corporation.'' \30\ These messages would
include, but would not be limited to, the Delivery, Pledge, and Release
messages referenced in the definition of CMS Delivery Information in
existing Rule 35.\31\
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    \29\ Id.
    \30\ Id.
    \31\ Id.
---------------------------------------------------------------------------

    Similarly, Rule 35 currently defines ``CMS Report'' to mean, ``with
respect to a CMS Participant and its CMS Sub-Account, the following
information identifying the CMS Securities that are, at the time of
such report, credited to such CMS Sub-Account: (i) The CUSIP, ISIN, or
other identification number of the CMS Securities, and (ii) the number
of shares or other units or principal amount of the CMS Securities.''
\32\ DTC states that this definition was drafted to align with DEGCL
specifications.\33\ Pursuant to the proposed rule change, the specific
language ``(i) the CUSIP, ISIN, or other identification number of the
CMS Securities, and (ii) the number of shares or other units or
principal amount of the CMS Securities'' would be deleted from the
definition of ``CMSP Position Reports.'' \34\
---------------------------------------------------------------------------

    \32\ Id.
    \33\ Id.
    \34\ Id.
---------------------------------------------------------------------------

    Finally, similar to what is provided for in Rule 35 today, the
proposed changes would provide that DTC would have no liability to any
Participant or Pledgee as a result of providing one or more CMSP
Reports to any CMSP pursuant to proposed Section 5 of Rule 35.\35\
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    \35\ Id.
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4. CMSP Instructions
    The proposed rule change would provide that a CMSP would be
authorized to instruct DTC, on behalf of the Participant or Pledgee,
for the Delivery, Pledge, or Release of securities credited to such
Participant or Pledgee's CMSP Account, as applicable.\36\ CMSP
Instructions would be subject to the terms and conditions of the DTC
Rules and Procedures applicable to Deliveries, Pledges, and Releases of
securities generally, including risk management controls.\37\ DTC
states that the purpose of this proposed change is to streamline
collateral processing by CMSPs by allowing them to receive information
directly from DTC and to take direct action on that information through
CMSP Instructions, on behalf of Participants and Pledgees.\38\
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    \36\ For a CMSP Account of a Participant, that would include
Delivery or Pledge. Id. For a CMSP Account of a Pledgee, that would
include Delivery or Release. Id.
    \37\ DTC states that its risk management controls, including
Collateral Monitor and Net Debit Cap (as defined in Rule 1, Section
1 of the Rules), are designed so that DTC may complete system-wide
settlement notwithstanding the failure to settle of its largest
Participant or Affiliated Family of Participants. Id. The Collateral
Monitor tests whether a Participant has sufficient collateral for
DTC to pledge or liquidate if that Participant were to fail to meet
its settlement obligation. Id. Pursuant to these controls under
applicable DTC Rules and Procedures, DTC states that it would not
process any Delivery or Pledge instruction order from a CMSP Account
that would cause the Participant to exceed its Net Debit Cap or to
have insufficient DTC Collateral to secure its obligations to DTC.
Id. DTC states that Deliveries would be processed in the same order
and with the same priority as otherwise provided in the DTC Rules
and Procedures (i.e., such Deliveries and Pledges would not take
precedence over any other type of Delivery or Pledge in the DTC
system). Id.
    \38\ Id.
---------------------------------------------------------------------------

    The proposal would not preclude instructions by the Participant or
Pledgee itself, or CMSP Instructions by another CMSP, with respect to
the same

CMSP Account.\39\ Furthermore, the proposed changes to Rule 35 would
provide that DTC has no liability (i) to a Participant or Pledgee for
acting in accordance with, or relying upon, CMSP Instructions, or (ii)
to any CMSP as a result of DTC acting in accordance with, or relying
upon, instructions of any other Person, including, but not limited to,
the Participant or Pledgee or any other designated CMSP.\40\
---------------------------------------------------------------------------

    \39\ Id.
    \40\ Id.
---------------------------------------------------------------------------

5. Ministerial Changes
    In connection with the foregoing, DTC proposes the following
ministerial changes to Rule 35 in order to conform the existing rule
text to the proposed changes, as well as to make stylistic edits: \41\
---------------------------------------------------------------------------

    \41\ Id.
---------------------------------------------------------------------------

    Title. DTC proposes to replace the current title ``CMS Reporting''
with ``CMSP Reports and Instructions,'' to reflect the amended
substance of the proposed rule.\42\
---------------------------------------------------------------------------

    \42\ Id.
---------------------------------------------------------------------------

    Section 1. For stylistic consistency, DTC proposes to insert the
title ``Certain Defined Terms'' for Section 1.\43\ DTC further proposes
to (i) delete the definitions of CMS, CMS Participant, CMS
Representative, CMS Securities, DEGCL, and DTCC; (ii) add definitions
for CMSP, CMSP Account, CMSP Instruction, and CMSP Reports; (iii)
replace the defined term ``CMS Delivery Information'' with ``CMSP
Information'' and simplify the definition by referring to ``a copy of
any message sent to the Participant or Pledgee'' with respect to a CMSP
Account, instead of ``a copy of any Delivery, Pledge, or Release
message sent to the CMS Participant by DTC, including the following
information: (x) The CUSIP, ISIN, or other identification number of
such CMS Securities, and (y) the number of shares or other units or
principal amount of such CMS Securities''; and (iv) replace the defined
term ``CMS Report'' with ``CMSP Position Report'' and simplify the
definition by removing the DEGCL specifications of ``(i) the CUSIP,
ISIN, or other identification number of the CMS Securities, and (ii)
the number of shares or other units or principal amount of the CMS
Securities.'' \44\
---------------------------------------------------------------------------

    \43\ Id.
    \44\ Id.
---------------------------------------------------------------------------

    Proposed Section 2 (New). DTC proposes to insert a new proposed
Section 2, titled ``Qualification as a CMSP.'' \45\ This section would
identify the aforementioned requirements that an entity must satisfy to
become a CMSP.\46\
---------------------------------------------------------------------------

    \45\ Id.
    \46\ Id.
---------------------------------------------------------------------------

    Section 2 (Proposed Section 3). DTC proposes to renumber Section 2
to Section 3, and to change the title of proposed Section 3 to ``CMSP
Accounts.'' \47\ DTC also proposes to modify subsection (a) to delete
DEGCL CMS-specific terms and to reflect that (i) a Participant or
Pledgee can designate one or more CMSP Accounts, as well as designate
one or more CMSPs for each CMSP Account, and (ii) as noted above,
describe what the designation of a CMSP entails, with respect to a CMSP
Account by a Participant or Pledgee would constitute.\48\ DTC further
proposes to modify subsection (b) to remove CMS-specific references, to
reflect the inclusion of Pledgees, CMSPs, and CMSP Instruction in the
proposed rule, and to make ministerial changes.\49\ Additionally, DTC
proposes to remove subsection (c) as it would be no longer relevant
because it relates exclusively to DEGCL.\50\
---------------------------------------------------------------------------

    \47\ Id.
    \48\ Notice, 83 FR at 35046-7.
    \49\ Notice, 83 FR at 35047.
    \50\ Id.
---------------------------------------------------------------------------

    Section 3 (Proposed Section 4). DTC proposes to renumber Section 3
as Section 4, and to change the title of the section to ``Instructions
on a CMSP Account.'' \51\ DTC further proposes to (i) modify subsection
(a) to remove provisions relating to the transfer of securities to a
CMS Sub-Account, and to insert a provision stating that a Participant
or Pledgee retains its right to instruct DTC with respect to its CMSP
Account, and (ii) modify subsection (b) to remove provisions relating
to the transfer of securities to a CMS Sub-Account, and to insert a
provision specifying that a CMSP may instruct the Delivery, Pledge, or
Release of securities to or from a CMSP Account for which it is
designated pursuant to proposed Section 3 of Rule 35.\52\ Further, DTC
proposes to insert the new subsection (c) that would state that all
Deliveries, Pledges, and Releases to or from a CMSP Account would be
subject to the terms and conditions of the DTC Rules and Procedures
applicable to Deliveries, Pledges, and Releases of securities
generally.\53\
---------------------------------------------------------------------------

    \51\ Id.
    \52\ Id.
    \53\ Id.
---------------------------------------------------------------------------

    Section 4. DTC proposes to delete this section, as it relates to
DEGCL specifications for a CMS Report.\54\
---------------------------------------------------------------------------

    \54\ Id.
---------------------------------------------------------------------------

    Section 5. DTC proposes to replace the current title of ``CMS
Delivery Information'' with ``CMSP Reports.'' \55\ DTC is further
proposing to insert proposed subsection (a) to provide for the
provision of CMSP Position Reports and CMSP Information to each CMSP
for each CMSP Account for which it is designated.\56\ DTC additionally
proposes to delete language relating to DEGCL-specific requirements
regarding ``CMS Delivery Information.'' \57\ Further, DTC proposes to
incorporate the remaining language of Section 5, modified to conform to
the defined terms of the proposed rule change, into proposed subsection
(b).\58\
---------------------------------------------------------------------------

    \55\ Id.
    \56\ Id.
    \57\ Id.
    \58\ Id.
---------------------------------------------------------------------------

    Section 6. DTC proposes to modify the section to (i) add references
to CMSPs, Pledgees, CMSP Reports, and CMSP Instructions, (ii) remove
references to CMS Participant, CMS Report, Delivery Information, and
CMS Representative, and (iii) update a cross-reference relating to CMSP
Reports.\59\ DTC further proposes to add disclaimers of liability to
(i) a Participant or Pledgee for acting in accordance with, or relying
upon, CMSP Instructions, or (ii) any CMSP as a result of DTC acting in
accordance with, or relying upon, instructions of any other Person,
including, but not limited to, the Participant or Pledgee or any other
designated CMSP, with respect to a CMSP Account.\60\
---------------------------------------------------------------------------

    \59\ Id.
    \60\ Id.
---------------------------------------------------------------------------

    For additional clarity, DTC also proposes to make ministerial
changes to (i) update articles, pronouns, and determiners, and (ii)
modify language for stylistic conformity within the proposed rule.\61\
---------------------------------------------------------------------------

    \61\ Id.
---------------------------------------------------------------------------

II. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act \62\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if it
finds that such proposed rule change is consistent with the
requirements of the Act and rules and regulations thereunder applicable
to such organization. The Commission believes the proposal is
consistent with the Act, specifically Section 17A(b)(3)(F) of the Act
and Rule 17Ad-22(e)(21) under the Act.\63\
---------------------------------------------------------------------------

    \62\ 15 U.S.C. 78s(b)(2)(C).
    \63\ 15 U.S.C. 78q-1(b)(3)(F); 17 CFR 240.17Ad-22(20).

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

A. Consistency With Section 17A

    Section 17A(b)(3)(F) of the Act \64\ requires, inter alia, that the
rules of the clearing agency be designed to promote the prompt and
accurate clearance and settlement of securities transactions.
---------------------------------------------------------------------------

    \64\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    As described above, DTC proposes to make five core changes to Rule
35. First, DTC proposes to no longer reference DEGCL as the sole CMS
provider under Rule 35 but, instead, to reference the new term CMSP and
its associated functions. Specifically, the proposed change would allow
any otherwise eligible partnership, corporation, or other organization
or entity that meets the proposed criteria to offer collateral
management services through DTC for the purpose of Rule 35. The
Commission believes that by expanding Rule 35 to include a broader
concept of a CMSP, not just one specific CMSP (i.e., DEGCL), the
proposed change (i) opens up the opportunity for other collateral
management providers to compete in offering their services under Rule
35, and (ii) affords Participants and Pledgees the opportunity to
evaluate whether another entity could better meet its collateral
management requirements. By increasing the opportunity for competition
and selection, the proposed change should help collateral management
providers, Participants, and Pledgees be better positioned to more
efficiently effect the settlement of collateral transactions under Rule
35. Therefore, the change would help promote the prompt and accurate
clearance and settlement of securities transactions.
    Second, as described above, DTC proposes to add to Rule 35 the term
CMSP Account and its associated functions. As proposed, a CMSP Account
would allow Pledgees, not just Participants, to use collateral
management service offerings of CMSPs for the purposes of Rule 35. By
establishing the ability for Pledgees to utilize collateral management
services under Rule 35, through the proposed CMSP Account, the proposal
affords Pledgees the same opportunities to manage such collateral
transactions through DTC as Participants. The Commission believes that
expanding Rule 35 to include Pledgees should help Pledgees more
efficiently effect the settlement of their collateral transactions at
DTC, thus helping to promote the prompt and accurate clearance and
settlement of such securities transactions.
    Third, as described above, DTC proposes to add to Rule 35 the term
CMSP Reports and its associated functions; namely, the CMSP Position
Report and the CMSP Information. The CMSP Position Report would enable
the CMSP to know what securities are credited to a Participant or
Pledgee's CMSP Account each day, while the CMSP Information would allow
the CMSP to know the Participant's or the Pledgee's real-time
correspondence with DTC. These two reports are designed to furnish the
CMSP with information needed to calculate collateral requirements and
facilitate the transfer of collateral between counterparties. As such,
the Commission believes that the CMSP Position Report and CMSP
Information would assist CMSPs in providing collateral management
services, and thereby, promote the prompt and accurate clearance and
settlement of those securities transactions.
    Fourth, as described above, the proposed rule change would allow a
CMSP to instruct DTC to Deliver, Pledge, or Release securities credited
to a CMSP Account, on behalf of a Participant or Pledgee. In doing so,
the proposed rule change should help reduce the number of actions that
a Participant or Pledgee that uses a CMSP would need to take in order
to effect the settlement of collateral transactions at DTC. The
Commission believes that the proposal would thereby help add efficiency
to the clearance and settlement process by providing straight-through
submission and processing of settlement instructions by a CMSP, without
further actions by the Participant or Pledgee. As such, the proposed
CMSP Instructions would help promote the prompt and accurate clearance
and settlement of securities transactions.
    Fifth, as described above, the proposal would make ministerial
changes to Rule 35 to conform the existing language in Rule 35 to the
proposed changes. The proposal would also make various stylistic edits
to the rule text. These changes are designed to help ensure that the
final rule text is coherent and all cross-references within the rule
text are current. The Commission believes the ministerial and stylistic
changes thereby would help Participants and Pledgees to better
understand their rights and obligations with respect to the collateral
management services provide under Rule 35. Therefore, the changes would
help promote the prompt and accurate clearance and settlement of such
transactions.
    As each of the aforementioned changes is designed to promote the
prompt and accurate clearance and settlement of securities
transactions, the Commission finds that the proposal is consistent with
the requirements Section 17A(b)(3)(F).

B. Consistency With Rule 17Ad-22(e)(21)

    Rule 17Ad-22(e)(21) promulgated under the Act requires, inter alia,
a covered clearing agency \65\ to establish, implement, maintain and
enforce written policies and procedures reasonably designed to be
efficient and effective in meeting the requirements of its participants
and the markets it serves.\66\
---------------------------------------------------------------------------

    \65\ A ``covered clearing agency'' means, among other things, a
clearing agency registered with the Commission under Section 17A of
the Exchange Act (15 U.S.C. 78q-1 et seq.) that is designated
systemically important by the Financial Stability Oversight Counsel
(``FSOC'') pursuant to the Payment, Clearing, and Settlement
Supervision Act of 2010 (12 U.S.C. 5461 et seq.). See 17 CFR
240.17Ad-22(a)(5)-(6). On July 18, 2012, FSOC designated DTC as
systemically important. U.S. Department of the Treasury, ``FSOC
Makes First Designations in Effort to Protect Against Future
Financial Crises,'' available at https://www.treasury.gov/press-center/press-releases/Pages/tg1645.asp. Therefore, DTC is a covered
clearing agency.
    \66\ 17 CFR 240.17Ad-22(e)(21).
---------------------------------------------------------------------------

    As described above, the proposal would amend Rule 35 to, generally,
(i) broaden what entities may serve as a CMSP, (ii) allow Participants
and Pledgees to utilize the services offered by Rule 35, (iii) and
permit Participants and Pledgees to designate one or more CMSPs, with
respect to a CMSP Account, to provide CMSP Instructions, as well as
receive CMSP Information and CMSP Position Reports. With these proposed
changes, the Commission believes that the proposal would grant both
Participants and Pledgees the flexibility to establish and structure
their respective CMSP Accounts, including the eligible CMSP that would
service the accounts, in a manner that is most effective and efficient
for the collateral management needs of that Participant or Pledgee and
for the specifications of its designated CMSP(s).
    The proposed rule change also would make ministerial revisions and
stylistic edits to Rule 35, as described above. These changes are
designed to help Participants and Pledgees better understand their
rights and obligations with respect to the services offered under Rule
35. By helping Participants and Pledgees better understand their rights
and obligations with respect to Rule 35, the Commission believes that
the proposed changes are designed to be efficient and effective in
meeting the requirements of Participants and Pledgees that take
advantage of DTC's collateral management services under Rule 35.

    Therefore, the Commission finds that the proposal is designed to be
efficient and effective in meeting the requirements of Participants and
Pledgees, consistent with Rule 17Ad-22(e)(21) under the Act.

III. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act, in particular
the requirements of Section 17A of the Act \67\ and the rules and
regulations thereunder.
---------------------------------------------------------------------------

    \67\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that proposed rule change SR-DTC-2018-006 be, and hereby is,
approved.\68\
---------------------------------------------------------------------------

    \68\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\69\
---------------------------------------------------------------------------

    \69\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-18784 Filed 8-29-18; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Rules and Regulations]
[Pages 46265-46267]
[FR Doc No: 2013-18185]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0917; FRL-9391-2]

Complex Polymeric Polyhydroxy Acids; Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Complex Polymeric Polyhydroxy Acids in
or on all food commodities. This regulation eliminates the need to
establish a maximum permissible level for residues of Complex Polymeric
Polyhydroxy Acids (CPPA) under FFDCA.

DATES: This regulation is effective July 31, 2013. Objections and
requests for hearings must be received on or before September 30, 2013,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2009-0917, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Menyon Adams, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document
electronically, please go to http://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0917 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
September 30, 2013. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2009-0917, by one of
the methods provided in 40 CFR 150.17(b).

II. Background and Statutory Findings

    In the Federal Register of January 13, 2010 (75 FR 1775) (FRL-8805-
6), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP
9F7645) by James R. Yowell of Spring Trading Company (the Petitioner),
on behalf of Floratine Biosciences Inc., 153 N. Main St., Suite 100,
Collierville, TN 38017. The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of Complex Polymeric Polyhydroxy Acids. That
document referenced a summary of the petition prepared by the
Petitioner, which is available in the docket, http://www.regulations.gov. No comments were received.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require 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. . . . '' Additionally, FFDCA section
408(b)(2)(D) requires that the Agency consider ``available information
concerning the cumulative effects of a particular pesticide's
residues'' and ``other substances that have a common mechanism of
toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its risk. EPA has also considered available
information concerning the variability of the sensitivities of major
identifiable subgroups of consumers, including infants and children.

A. Overview of Complex Polymeric Polyhydroxy Acids

    Complex Polymeric Polyhydroxy Acids (CPPA) is a complex mixture of
naturally occurring organic substances found in dead plant materials.
The components of CPPA are widespread in nature, being found in soils
and fresh and salt water environments as a result of decaying plant
materials, and are used to condition agricultural soils.
    Its major components are humic acid, fulvic acid, and tannins, and
their relative concentrations in soil and water systems are influenced
by environmental conditions, such as climate, soil types, vegetation,
and hydrology. CPPA is made by concentrating the organic substances
from water leached through forest soil using a proprietary
manufacturing process.

B. Biochemical Pesticide Toxicology Data Requirements

    All applicable mammalian toxicology data requirements supporting
the petition to exempt residues of CPPA from the requirement of a
tolerance in or on all food commodities have been fulfilled. No acute,
subchronic, or chronic toxicity endpoints were identified in guideline
studies or in data obtained from open technical literature. Moreover,
CPPA is not a mutagen, and is not a developmental toxicant. There are
no known effects on endocrine systems via oral, dermal, or inhalation
exposure. For a more in-depth synopses of the data upon which EPA
relied and its human health risk assessment based on that data can be
found on pages 8 through 11 and in Appendix A of the draft document
entitled, ``Biopesticides Registration Action Document, Complex
Polymeric Polyhydroxy Acids (CPPA),'' available in the docket for this
action as described under ADDRESSES.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).

A. Dietary Exposure

    The proposed use pattern may result in dietary exposure with
possible residues in or on agricultural commodities. No significant
exposure via drinking water is expected beyond what is already present,
when CPPA is used according to the product label directions because the
active ingredient biodegrades rapidly (half-life = 25.7 days) in the
environment, is applied at low application rates, and is not directly
applied to water.
    Should exposure occur, however, minimal to no risk is expected for
the general population, including infants and children, due to low
toxicity of CPPA and its components as demonstrated in the data
submitted and evaluated by the Agency. In addition, the lack of
reported incidents in spite of the exposure from use in commercial
agriculture for years to condition soils and its abundance in nature
support a conclusion that minimal to no risk is expected.

B. Other Non-Occupational Exposure

    Non-occupational exposure is not expected because CPPA will be
applied as a commercial plant growth regulator for agricultural
purposes only.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has determined CPPA to have a non-toxic mode of action;
therefore, 408(b)(2)(D)(v) does not apply.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that, in considering the
establishment of a tolerance or tolerance exemption for a pesticide
chemical residue, EPA shall assess the available information about
consumption patterns among infants and children, special susceptibility
of infants and children to pesticide chemical residues, and the
cumulative effects on infants and children of the residues and other
substances with a common mechanism of toxicity. In addition, FFDCA
section 408(b)(2)(C) 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 that a different margin of safety will be safe for infants
and children. This additional margin of safety is commonly referred to
as the Food Quality Protection Act Safety Factor. In applying this
provision, EPA either retains the default value of 10X, or uses a
different additional safety factor when reliable data are available to
support the choice of a different safety factor.
    As part of its qualitative assessment, EPA evaluated the available
toxicity and exposure data on CPPA and considered its validity,
completeness, and reliability, as well as the relationship of this
information to human risk. EPA considers the toxicity database to be
complete and has identified no residual uncertainty with regard to
prenatal and postnatal toxicity or exposure. No hazard was identified
based on the available studies. Based upon its evaluation, EPA
concludes that there are no threshold effects of concern to infants,
children, or adults when CPPA is applied as a plant growth regulator
and used in accordance with label directions and good agricultural
practices. As a result, EPA concludes that no additional margin of
exposure (safety) is necessary.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes for
the reasons stated in Unit VI. and because EPA is establishing an
exemption from the requirement of a tolerance without any numerical
limitations.

B. International Residue Limits

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

VIII. Conclusion

    EPA concludes that there is a reasonable certainty that no harm
will result to the U.S. population, including infants and children,
from aggregate exposure to residues of CPPA. Therefore, EPA is
establishing an exemption from the requirement of a tolerance for
residues of CPPA in or on all food commodities when applied as a plant
growth regulator and used in accordance with good agricultural
practices.

IX. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this final rule has been exempted from review
under Executive Order 12866, this final rule is not subject to
Executive Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption from
the requirement of a tolerance in this final rule, do not require the
issuance of a proposed rule, the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

X. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: July 9, 2013.
Steven Bradbury,
Director, 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. Add Sec.  180.1321to subpart D to read as follows:

Sec.  180.1321  Complex Polymeric Polyhydroxy Acids; exemption from the
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
the residues of complex polymeric polyhydroxy acids in or on all food
commodities when applied as a plant growth regulator and used in
accordance with good agricultural practices.

[FR Doc. 2013-18185 Filed 7-30-13; 8:45 am]
BILLING CODE 6560-50-P