[Federal Register: July 13, 2009 (Volume 74, Number 132)]
[Proposed Rules]
[Page 33395-33397]
[DOCID:fr13jy09-18]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2009-0384; FRL-8929-8]

Revisions to the California State Implementation Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve revisions to the San Joaquin
Valley Unified Air Pollution Control District (SJUVAPCD) portion of the
California State Implementation Plan (SIP). These revisions concern
oxides of nitrogen (NOX) emissions from Stationary Gas
Turbines. We are approving a local rule that regulates these emission
sources under the Clean Air Act as amended in 1990 (CAA or the Act). We
are taking comments on this proposal and plan to follow with a final
action.

DATES: Any comments must arrive by August 12, 2009.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2009-0384, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the online instructions.
    2. E-mail<EMAIL_ADDRESS>

    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://
www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://
www.regulations.gov or e-mail. http://www.regulations.gov is an
``anonymous access'' system, and EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send e-mail directly to EPA, your e-mail address will be
automatically captured and included as part of the public comment. If
EPA cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material), and some may not be publicly available in either location
(e.g., CBI). To inspect the hard copy materials, please schedule an
appointment during normal business hours with the contact listed in the
FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Idalia Perez, EPA Region IX, (415)
972-3248<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rule did the State submit?
    B. Are there other versions of this rule?
    C. What is the purpose of the submitted rule revision?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rule?
    B. Does the rule meet the evaluation criteria?
    C. EPA Recommendations To Further Improve the Rule
    D. Public Comment and Final Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rule did the State submit?

    Table 1 lists the rule addressed by this proposal with the date
that it was adopted by the local air agency and submitted by the
California Air Resources Board (CARB).

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
                                       Rule                Rule title               Adopted        Submitted
----------------------------------------------------------------------------------------------------------------
SJVUAPCD.............................         4703  Stationary Gas Turbines.....        09/20/07        03/07/08
----------------------------------------------------------------------------------------------------------------

    On April 17, 2008, this rule submittal was found to meet the
completeness criteria in 40 CFR Part 51, Appendix V, which must be met
before formal EPA review.

B. Are there other versions of this rule?

    We approved a version of Rule 4703 into the SIP on May 18, 2004.
The SJVUAPCD adopted an earlier revision to the SIP-approved version on
August 17, 2006 and CARB submitted it to us on December 29, 2006. While
we can act on only the most recently submitted version, we have
reviewed materials provided with previous submittal.

C. What is the purpose of the submitted rule revision?

    NOX helps produce ground-level ozone, smog and
particulate matter, which harm human health and the environment.
Section 110(a) of the CAA requires States to submit regulations that
control NOX emissions. Rule 4703 regulates emissions of
oxides of nitrogen (NOX) and carbon monoxide (CO) from
stationary gas turbine systems with ratings equal to or greater than
0.3 MW or a maximum heat input rating greater than 3 million Btu/hr.
The Rule was revised to include more stringent emission limits and
eliminate some exemptions present in the SIP-approved version. EPA's
technical support document (TSD) has more information about this rule.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rule?

    Generally, SIP rules must be enforceable (see section 110(a) of the
Act), must require Reasonably Available Control Technology (RACT) for
each category of sources covered by a Control Techniques Guidelines
(CTG) document as well as each major source in nonattainment areas (see
sections 182(a)(2) and 182(f)), and must not relax existing
requirements (see sections 110(l) and 193). The SJVUAPCD regulates an
ozone nonattainment area (see 40 CFR part 81), so Rule 4703 must
fulfill RACT.
    Guidance and policy documents that we use to help evaluate
enforceability and RACT requirements consistently include the
following:
    1. ``State Implementation Plans; Nitrogen Oxides Supplement to the
General Preamble; Clean Air Act Amendments of 1990 Implementation of
Title I; Proposed Rule,'' (the NOX Supplement), 57 FR 55620,
November 25, 1992.
    2. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations,'' EPA, May 25, 1988 (the Bluebook).
    3. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    4. ``Improving Air Quality with Economic Incentive Programs,'' EPA,
452/R-01-001, January 2001.
    5. ``Alternative Control Technology Document, NOX
Emissions from Stationary Gas Turbines,'' EPA, 453/R-93-007, January
1993.

B. Does the rule meet the evaluation criteria?

    We believe this rule is consistent with the relevant policy and
guidance regarding enforceability, RACT, and SIP relaxations. The TSD
has more information on our evaluation.

C. EPA Recommendations To Further Improve the Rule

    The TSD describes additional rule revisions that do not affect
EPA's current action but are recommended for the next time the local
agency modifies the rule.

D. Public Comment and Final Action

    Because EPA believes the submitted rule fulfills all relevant
requirements, we are proposing to fully approve it as described in
section 110(k)(3) of the Act. We will accept comments from the public
on this proposal for the next 30 days. Unless we receive convincing new

information during the comment period, we intend to publish a final
approval action that will incorporate this rule into the Federally
enforceable SIP.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: June 22, 2009.
Jane Diamond,
Acting Deputy Regional Administrator, Region IX.
 [FR Doc. E9-16495 Filed 7-10-09; 8:45 am]

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[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Pages 34955-34958]
[FR Doc No: 2012-14227]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0294]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Contact
Substance Notification Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
12, 2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0495.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, II, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Food Contact Substance Notification Program--21 CFR 170.101, 170.106,
and 171.1 (Control Number 0910-0495)--Extension

    Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348(h)) establishes a premarket notification
process for food contact substances. Section 409(h)(6) of the FD&C Act
defines a ``food contact substance'' as ``any substance intended for
use as a component of materials used in manufacturing, packing,
packaging, transporting, or holding food if such use is not intended to
have any technical effect in such food.'' Section 409(h)(3) of the FD&C
Act requires that the notification process be used for authorizing the
marketing of food contact substances except when: (1) FDA determines
that the submission and premarket review of a food additive petition
(FAP) under section 409(b) of the FD&C Act is necessary to provide
adequate assurance of safety or (2) FDA and the manufacturer or
supplier agree

that an FAP should be submitted. Section 409(h)(1) of the FD&C Act
requires that a notification include: (1) Information on the identity
and the intended use of the food contact substance and (2) the basis
for the manufacturer's or supplier's determination that the food
contact substance is safe under the intended conditions of use.
    Sections 170.101 and 170.106 of FDA's regulations (21 CFR 170.101
and 170.106) specify the information that a notification must contain
and require that: (1) A food contact substance notification (FCN)
include a completed and signed Form FDA 3480 and (2) a notification for
a food contact substance formulation include a completed and signed
Form FDA 3479. These forms serve to summarize pertinent information in
the notification. The forms facilitate both preparation and review of
notifications because the forms serve to organize information necessary
to support the safety of the use of the food contact substance. The
burden of filling out the appropriate form has been included in the
burden estimate for the notification.
    Currently, interested persons transmit an FCN submission to the
Office of Food Additive Safety in the Center for Food Safety and
Applied Nutrition using Form FDA 3480 whether it is submitted in
electronic or paper format. FDA recently made minor revisions to Form
FDA 3480 to better enable its use for electronic submission and to
prompt FCN submitters to include certain information in a standard
format. FDA estimates that the revisions to Form FDA 3480 will not
change the amount of time necessary to complete the form.
    In addition to its required use with FCNs, revised Form FDA 3480 is
recommended to be used to organize information within a Pre-
notification Consultation or Master File submitted in support of an FCN
according to the items listed on the form. Master Files can be used as
repositories for information that can be referenced in multiple
submissions to the Agency, thus minimizing paperwork burden for food
contact substance authorizations. FDA estimates that the amount of time
for respondents to complete the revised Form FDA 3480 for these types
of submissions will be 0.5 hours.
    FDA has recently developed a new form, which the Agency recommends
be used with each submission of additional information (i.e. amendment)
to an FCN submission currently under Agency review, as well as be used
to submit an amendment to a Pre-notification Consultation, or for an
amendment to Master File in support of an FCN, whether submitted in
electronic format or paper format. New Form FDA 3480A is entitled
``Amendment to an Existing Food Contact Substance Notification, a Pre-
Notification Consultation, or a Food Master File.'' The form, and
elements that would be prepared as attachments to the form, can be
submitted in electronic format. Form FDA 3480A helps the respondent
organize their submission to focus on the information needed for FDA's
safety review. FDA estimates that the amount of time for respondents to
complete the new Form FDA 3480A will be 0.5 hours because the new form,
used solely for transmitting an amendment, is much shorter than Form
FDA 3480. Amendments include the following information on new Form FDA
3480A and in attachments to the form:
     Date of submission;
     Whether the notifier has determined that all files
provided in an electronic transmission are free of computer viruses;
     Whether the submission is an amendment to an FCN
submission, a Pre-Notification Consultation, or a Master File;
     The format of the submission (i.e., Electronic Submissions
Gateway (ESG), transmission on electronic physical media such as CD-ROM
or DVD, or paper);
     The name of and contact information for the submitter,
including the identity of the contact person and the company name (if
applicable);
     The name of and contact information for any agent or
attorney who is authorized to act on behalf of the notifier; and
     A brief description of the information provided and the
purpose(s) of the amendment.
    Section 171.1 of FDA's regulations (21 CFR 171.1) specifies the
information that a petitioner must submit in order to: (1) Establish
that the proposed use of an indirect food additive is safe and (2)
secure the publication of an indirect food additive regulation in parts
175 through 178 (21 CFR parts 175 through 178). Parts 175 through 178
describe the conditions under which the additive may be safely used.
    In addition, FDA's guidance document entitled ``Use of Recycled
Plastics in Food Packaging: Chemistry Considerations'' provides
assistance to manufacturers of food packaging in evaluating processes
for producing packaging from post-consumer recycled plastic. The
recommendations in the guidance address the process by which
manufacturers certify to FDA that their plastic products are safe for
food contact.
    Description of Respondents: The respondents to this information
collection are manufacturers of food contact substances.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
  21 CFR Section or other category          FDA Form No.            Number of       responses per     Total annual     Average burden      Total hours
                                                                   respondents       respondent         responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.106 \2\ (Category A)...........  FDA 3479.................                 5                 1                 5                 2                10
170.101 \3, 7\ (Category B)........  FDA 3480.................                 5                 1                 5                25               125
170.101 \4, 7\ (Category C)........  FDA 3480.................                 5                 2                10               120             1,200
170.101 \5, 7\ (Category D)........  FDA 3480.................                33                 2                66               150             9,900
170.101 \6, 7\ (Category E)........  FDA 3480.................                30                 1                30               150             4,500
Pre-notification Consultation or     FDA 3480.................                60                 1                60               0.5                30
 Master File (concerning a food
 contact substance).\8\

Amendment to an existing             FDA 3480A................                50                 1                50               0.5                25
 notification (170.101), amendment
 to a Pre-notification
 Consultation, or amendment to a
 Master File (concerning a food
 contact substance).\9\
171.1 Indirect Food Additive         N/A......................                 1                 1                 1            10,995            10,995
 Petitions.
Use of Recycled Plastics in Food     N/A......................                10                 1                10                25               250
 Packaging: Chemistry
 Considerations.
������������������������������������
    Total..........................  .........................  ................  ................  ................  ................            27,035
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Notifications for food contact substance formulations and food contact articles. These notifications require the submission of Form FDA 3479
  (``Notification for a Food Contact Substance Formulation'') only.
\3\ Duplicate notifications for uses of food contact substances.
\4\ Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions.
\5\ Notifications for uses that are the subject of moderately complex food additive petitions.
\6\ Notifications for uses that are the subject of very complex food additive petitions.
\7\ These notifications require the submission of Form FDA 3480.
\8\ These notifications recommend the submission of Form FDA 3480.
\9\ These notifications recommend the submission of Form FDA 3480A.

    The forms in table 1 of this document, and elements that would be
prepared as attachments to the forms, may be submitted in electronic
format through the ESG; email, if appropriate; or may be submitted in
paper format, or as electronic files on physical media with paper
signature page. FDA expects that most if not all businesses filing
these submissions in the next 3 years will choose to take advantage of
the option of electronic submission. Thus, the burden estimates in
Table 1 of this document are based on the expectation of 100 percent
participation in the electronic submission process. The opportunity to
provide the information in electronic format could reduce the Agency's
previous estimates for the time to prepare each submission. However, as
a conservative approach for the purpose of this analysis, FDA is
assuming that the availability of the revised or new forms and the
opportunity to submit the information in electronic format will have no
effect on the average time to prepare a submission.
    These estimates are based on FDA's experience with the food contact
substance notification program. Based on input from industry sources,
FDA estimates that approximately five respondents will submit one
notification annually for food contact substance formulations (Form FDA
3479), for a total of five responses. FDA estimates the reporting
burden to be 2 hours per response, for a total burden of 10 hours. FDA
also has included five expected duplicate submissions in the second row
of table 1 of this document. FDA expects that the burden for preparing
these notifications primarily will consist of the manufacturer or
supplier filling out Form FDA 3480, verifying that a previous
notification is effective, and preparing necessary documentation. Thus,
FDA estimates that five respondents will submit one such submission
annually, for a total of five responses. FDA estimates the reporting
burden to be 25 hours per response, for a total burden of 125 hours.
    Based on the submissions received, FDA identified three other tiers
of FCNs that represent escalating levels of burden required to collect
information (denoted as Categories C, D, and E in the third, fourth,
and fifth rows of table 1 of this document). FDA estimated the median
number of hours necessary for collecting information for each type of
notification within each of the three tiers based on input from
industry sources. FDA estimates that 5 respondents will submit two
Category C submissions annually, for a total of 10 responses. FDA
estimates the reporting burden to be 120 hours per response, for a
total burden of 1,200 hours. FDA estimates that 33 respondents will
submit two Category D submissions annually, for a total of 66
responses. FDA estimates the reporting burden to be 150 hours per
response, for a total burden of 9,900 hours. FDA estimates that 30
respondents will submit one Category E submission annually, for a total
of 30 responses. FDA estimates the reporting burden to be 150 hours per
response, for a total burden of 4,500 hours.
    Based on the submissions received, FDA estimates that 60
respondents will submit information to a Pre-notification Consultation
or a Master File in support of FCN submission using Form FDA 3480. FDA
estimates the reporting burden to be 0.5 hours per response, for a
total burden of 30 hours.
    Based on the submissions received, FDA estimates that 50
respondents will submit an amendment (Form FDA 3480A) to a substantive
or non-substantive request of additional information to an incomplete
FCN submission, for an amendment to a Pre-notification Consultation, or
for an amendment to a Master File in support of an FCN. FDA estimates
the reporting burden to be 0.5 hours per response, for a total burden
of 25 hours.
    Based on the submissions received, FDA estimates that one
respondent will submit one indirect food additive petition under Sec.
171.1, for a total of one response. FDA estimates the reporting burden
to be 10,995 hours per response, for a total burden of 10,995 hours.
    FDA estimates that 10 respondents will utilize the recommendations
in the guidance document entitled ``Use of Recycled Plastics in Food
Packaging: Chemistry Considerations,'' to develop the additional
information for one such submission annually, for a total of 10
responses. FDA estimates the reporting

burden to be 25 hours per response, for a total burden of 250 hours.
    As noted, FDA estimates that all of the future Forms FDA 3479,
3480, and 3480A submissions will be made electronically through the
ESG. While FDA does not charge for the use of the ESG, FDA requires
respondents to obtain a public key infrastructure certificate in order
to set up the account. This can be obtained in-house or outsourced by
purchasing a public key certificate that is valid for 1 year to 3
years. The certificate typically costs from $20 to $30.

    Dated: June 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14227 Filed 6-11-12; 8:45 am]
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[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Proposed Rules]
[Page 37564]
[FR Doc No: 2016-13695]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2015-0009; EPA-R05-OAR-2015-0314; FRL-9946-79-Region 5]

Air Plan Approval; Illinois; NAAQS Update

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revised rules submitted by the State of Illinois as State
Implementation Plan (SIP) revisions. The submitted rules update
Illinois' ambient air quality standards to include the 2012 primary
National Ambient Air Quality Standard (NAAQS) for fine particulate
matter (PM2.5), add EPA-promulgated monitoring methods, and
address the ``sunset provisions'' in our regulation, finding that the
1971 NAAQS for sulfur dioxide no longer applies to the Lemont and Pekin
areas in Illinois. In addition, the revised rules contain the timing
requirements for the ``flagging of exceptional events'' and the
submitting of documentation supporting the determination of exceptional
events for the 2012 primary annual averaged PM2.5 standard.

DATES: Comments must be received on or before July 11, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2015-0009 or EPA-R05-OAR-2015-0314 at http://www.regulations.gov or
via email to<EMAIL_ADDRESS>For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. For either manner of submission, EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Edward Doty, Air Programs Branch (AR-
18J), Environmental Protection Agency, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittals as a direct final
rule without prior proposal because the Agency views these as
noncontroversial submittals and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that, if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: May 10, 2016.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.
[FR Doc. 2016-13695 Filed 6-9-16; 8:45 am]
 BILLING CODE 6560-50-P


 EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Kable Bo Davis<PHONE_NUMBER>

BASF Corporation

2E8021

	EPA has received a pesticide petition (2E8021) from BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.490 by establishing a tolerance for residues of imazapic (+-)-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1-H-imidazol-2-yl]-5-methyl-3-pyridinecarboxylic acid in or on the raw agricultural commodity sugarcane at 0.01 parts per million (ppm).  EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The metabolic pathway of imazapic is understood and is similar in a range of different crops including Bermuda grass, sugarcane and peanuts (a legume). Parent imazapic and the hydroxymethyl metabolite M715H001 (CL 263,284) were identified as major components of the total residue. Imazapic is metabolized via oxidative hydroxylation of the 5-methyl substituent to form the 5-hydroxymethyl metabolite M715H001 (CL263, 284), which in immature plants and mature leaves is subsequently conjugated with glucose to form metabolite M715H002 (CL189, 215).

	2. Analytical method. The proposed analytical method for detecting residues of imazapic and the metabolites M715H001 (CL 263,284) and M715H002 (CL 189,215) in sugarcane is an LC-MS/MS method.  This validated method has an LOQ of 0.01 mg/kg.

Enforcement methods for analysis of residues of imazapic and metabolite M715H001 (CL 263,284) in animal commodities have been previously submitted.  The analytical method for analysis in meat and meat by-products is based on capillary electrophoreses with confirmation by LC/MS.  The method LOQ is 0.05 mg/kg for meat and meat by-products.  The analytical method for analysis in milk and fat is based on determination by LC/MS with confirmation by LC/MS/MS.  The method LOQ is 0.01 mg/kg for milk and 0.05 mg/kg for fat.  Both methods were successfully validated by an independent laboratory validation.

	3. Magnitude of residues. i. Sugarcane.  Imazapic was applied at labeled rates in 9 field trials.  Residues of imazapic were below the limit of quantitation (<0.01 mg/kg) in all treated and control samples, 148 to 365 days after treatment.

In two residue trials, a separate pre-emergence application was made at a rate of 5x maximum proposed label rate, for the purposes of providing cane for processing.  Processed commodities were not analyzed since residues of imazapic in the cane stalks treated at five times the proposed application rate were below the limit of quantitation (<0.01 mg/kg) for each analyte and parent. Processing studies showed no concentration of residues from sugarcane into sugar or molasses.

ii.  Ruminants. Not relevant to import tolerances since imported crops would not be used for animal feed.

iii.  Poultry. Not relevant to import tolerances since imported crops would not be used for poultry feed.

B. Toxicological Profile

	1. Acute toxicity. Imazapic technical is considered to be non-toxic (toxicity category IV) to the rat by the oral route of exposure. In an acute oral toxicity study in rats, the LD50 value of imazapic technical was greater than 5,000 milligrams/ kilograms body weight (mg/kg bw) for males and females. The results from an acute dermal toxicity study in rabbits indicate that imazapic is slightly toxic (toxicity category III) to rabbits by the dermal route of exposure. The dermal LD50 value of imazapic technical was greater than 2,000 mg/kg bw for both male and female rabbits. Imazapic technical is considered to be nontoxic (toxicity category IV) to the rat by the respiratory route of exposure.  The 4-hour LC50 value was greater than 5.52 mg/L (analytical) for both males and females. Imazapic technical was shown to be non-irritating to rabbit skin (toxicity category IV) and minimally irritating to the rabbit eye (toxicity category III). Based on the results of a dermal sensitization study, imazapic technical is not considered a sensitizer in guinea pigs.

	2. Genotoxicity. Imazapic technical was tested in a battery of in vitro and in vivo genotoxicity assays measuring several different endpoints of potential genotoxicity. Collective results from these studies indicate that imazapic does not pose a mutagenic or genotoxic risk.

	3. Reproductive and developmental toxicity. i. The developmental toxicity study in Sprague Dawley rats conducted with imazapic technical showed no evidence of teratogenic effects in fetuses and no evidence of developmental toxicity. Thus, imazapic is neither a developmental toxicant nor a teratogen in the rat. In the rat developmental toxicity study with imazapic technical, the no observed adverse effect level (NOAEL) for maternal toxicity and developmental toxicity was 1,000 mg/kg bw/day, the highest dose tested.

ii. Results from a developmental toxicity study in New Zealand White rabbits with imazapic technical also indicated no evidence of teratogenicity or developmental toxicity. Thus, imazapic technical is neither a developmental toxicant nor a teratogen in the rabbit. In the rabbit developmental toxicity study, the NOAEL for maternal toxicity was 350 mg/kg bw/day, based on decreased food consumption and body weight gain at 500 mg/kg bw/day, the next highest dose tested. The NOAEL for developmental toxicity was determined by EPA to be 500 mg/kg bw/day; the excessive mortality in dams at 700 mg/kg bw/day (the highest dose tested) resulted in too few fetuses that were available for evaluation.

iii. The results from the two-generation reproduction toxicity study in rats with imazapic technical support a NOAEL for parental toxicity of 20,000 ppm (or approximately 1,205 mg/kg bw/day in males and 1,484 mg/kg bw/day in females, calculated from food consumption data), the highest concentration tested. The NOAEL for growth and development of the offspring is also 20,000 ppm, or approximately 1,205 mg/kg bw/day in males and 1,484 mg/kg bw/day in females. Results from the reproduction study and the developmental toxicity studies conducted with imazapic technical show no increased sensitivity to developing offspring as compared to parental animals, because the NOAELs for growth and development of offspring were equal to or greater than the NOAELs for parental toxicity.

	4. Subchronic toxicity. i. A short-term (21-day) dermal toxicity study in rabbits was conducted with imazapic technical. No dermal irritation or abnormal clinical signs were observed at dose levels up to and including 1,000 mg/kg bw/day (highest dose tested), supporting a NOAEL for dermal irritation and systemic toxicity of 1,000 mg/kg bw/day.

ii. In a subchronic (13-week) dietary toxicity study in rats with imazapic technical, no signs of systemic toxicity were noted, supporting a NOAEL of 20,000 ppm (or approximately 1,552 mg/kg/day for males and 1,728 mg/kg/day for females, calculated from food consumption data), the highest concentration tested. The requirement for a subchronic dietary toxicity study in non-rodents is satisfied by the one-year dietary toxicity study in dogs.

	5. Chronic toxicity. i. A one-year dietary toxicity study was conducted with imazapic technical in Beagle dogs at dietary concentrations of 0, 5,000, 20,000, and 40,000 ppm. In this study, the NOAEL for systemic toxicity was less than 5,000 ppm or approximately 158 mg/kg bw/day (137 mg/kg bw/day for males and 180 mg/kg bw/day for females), calculated from food consumption data, based on a slight skeletal myopathy, characterized by degeneration/necrosis of single fibers (minimal severity) and lymphocyte/macrophage infiltration in skeletal muscle, in males and females, and slightly decreased serum creatinine in females at 5,000 ppm (lowest concentration tested).

The skeletal myopathy observed at 5,000 ppm was considered of minimal toxicological significance because the limited presence and the minimal severity of skeletal myopathy were evident in only a few fibers out of hundreds evaluated per section per animal. Further, these focal myopathies of minimal severity were not consistently diagnosed in all skeletal muscles sites examined per dog (i.e., vastus and abdominal muscles, diaphragm and esophagus). Moreover, no clinical observations indicative of muscle dysfunction were noted in any animal in the study. Finally, although the skeletal myopathy noted at 40,000 ppm (highest concentration tested) was associated with increases in creatine kinase, aspartate aminotransferase and lactate dehydrogenase, no statistically or biologically significant increases in these serum enzymes were noted during the study period for animals in the 5,000 ppm group. As such, the minimal myopathy diagnosed microscopically at 5,000 ppm was not considered to impair or adversely affect the functional capacity of the affected skeletal muscles.

ii. In a 2-year chronic dietary oncogenicity and toxicity study in rats conducted with imazapic technical, the NOAEL for oncogenicity and chronic systemic toxicity was 20,000 ppm (approximately 1,029 mg/kg bw/day in males, 1,237 mg/kg bw/day in females, calculated from food consumption data), the highest concentration tested.

iii. An 18-month chronic dietary oncogenicity and toxicity study in mice with imazapic technical supports a NOAEL for oncogenicity and for chronic systemic toxicity of 7,000 ppm (or approximately 1,134 mg/kg bw/day in males, 1,422 mg/kg bw/day in females, calculated from food consumption data), the highest concentration tested.

The EPA has classified imazapic as a group E carcinogen (evidence of noncarcinogenicity for humans) based on the absence of treatment-related tumors in acceptable carcinogenicity studies in both rats and mice.

	6. Animal metabolism. The rat, goat and hen metabolism studies indicate that the qualitative nature of the residues of imazapic in animals is adequately understood.

In the rat metabolism study conducted with radiolabeled imazapic (BAS 715 H, CL 263,222), urinary excretion was the primary elimination route with 94% to 102% of the radioactivity excreted in the urine.  The major component in the urine and feces was the unchanged parent compound.

Lactating goats were orally treated using radiolabeled imazapic.  Imazapic was mainly eliminated from the goat through urine and feces.  HPLC of goat urine showed essentially unchanged imazapic, while residues in feces were comprised of imazapic and low levels of hydroxymethyl metabolites M715H001 (CL 263,284).  There were no detectable radiolabeled imazapic-derived residues in milk during or after treatment, nor in tissues except kidney 20 hours after the last dose.  The [14]C-residue in the high-dose kidney (0.05 mg/kg) was predominantly parent imazapic with low levels of metabolite M715H001 (CL 263,284, 8% TRR, <0.01 mg/kg) and two unknowns, each <=0.02 mg/kg.

A ruminant metabolism study was also conducted with the radiolabeled imazapic hydroxymethyl metabolite M715H001 (CL 263,284).  During treatment, TRR in the daily blood and milk samples were less than 0.01 mg/kg, regardless of the treatment dose levels. The TRR in liver, muscle, and omental fat were less than 0.01 mg/kg, regardless of the dose level. Analysis of the kidney extract showed that 9% (<0.01 mg/kg) of the extractable TRR was CL 263,284.

A metabolism study was performed on hens using radiolabeled imazapic.  Total recovery of radioactivity in urine and feces was 90.6% and 95.2% for the low and high doses, respectively.  Residues in all tissues (liver, kidney, muscle, skin with adhering fat), blood and eggs were <0.01 mg/kg, the validated detection limit.

A poultry metabolism study was also conducted with the radiolabeled imazapic hydroxymethyl metabolite M715H001 (CL 263,284).  Total recovery of radioactivity in urine and feces was 85.3% and 88.6% for the low and high doses, respectively.  Residues in all tissues, liver, kidney, muscle, skin with adhering fat, blood and eggs, were less than 0.01 mg/kg, the validated detection limit.

	7. Metabolite toxicology. Metabolism studies in grass, peanuts and sugarcane indicate that the only significant metabolites are the hydroxymethyl resulting from hydroxylation of the methyl group at the 5-position of the pyridine ring, (+-)-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-hydroxymethyl-3-pyridinecaroxylic acid, and the conjugate resulting from glucosylation at the hydroxyl group. The hydroxymethyl metabolite was also identified in minor quantities in the rat metabolism study and in the goat metabolism study. No additional toxicologically significant metabolites were detected in the plant or animal metabolism studies.

	8. Endocrine disruption. Collective organ weight data and histopathological findings from the two-generation rat reproductive study, as well as from the subchronic and chronic toxicity studies in three different animal species, demonstrate no apparent estrogenic effects or treatment-related effects of imazapic on the endocrine system.

C. Aggregate Exposure

	1. Dietary exposure.

	i. Food.

a. Acute Dietary Exposure.  An acute dietary assessment is not necessary because no acute dietary endpoint was selected based on the absence of an appropriate endpoint attributable to a single dose of imazapic.

b. Chronic Dietary Exposure.  A Tier 1 assessment of potential chronic dietary exposure was performed for the proposed import tolerance for use of imazapic on sugarcane.  The assessment was done using DEEM(TM), incorporating the current tolerances as listed in 40 CFR 180.490 on peanut, tissues of cattle, sheep, goats, and horses, and milk and the proposed tolerance for sugarcane.  For this Tier 1 analysis, tolerance values were used for sugarcane at 0.01 mg/kg ; peanut at 0.1 mg/kg; fat of cattle, sheep, goats, and horses at 0.1 mg/kg; kidney of cattle, sheep, goats, and horses at 1.0 mg/kg; meat byproducts, except kidney of cattle, sheep, goats, and horses at 0.1 mg/kg; meat of cattle, sheep, goats, and horses at 0.1 mg/kg; and milk at 0.1 mg/kg.  Chronic dietary exposures for the overall U.S. population and population subgroups, including infants and children were compared to the chronic Reference Dose (RfD) of 0.46 mg/kg/day (based on a LOAEL of 137 mg/kg bw/day from the chronic dog toxicology study and a safety factor of 300).  Results of the chronic dietary analyses for all population subgroups examined were below 1.0% of the chronic RfD.  Exposure estimates for children 1-2 years old, the most highly exposed subpopulation, were only 0.003876 mg/kg bw/day (or 0.8% of the RfD).  Therefore, the results of the chronic dietary assessment demonstrate a reasonable certainty of no harm from the proposed and existing uses of imazapic.

      ii. Drinking water.  Drinking water residues at an estimated drinking water concentration (EDWC) of 14 μg/L, i.e., the maximum level estimated by EPA, as reported in the 2001 Federal Register notice (66 FR 66325) were included in a dietary assessment using DEEM(TM).  A proposed tolerance for an imported commodity would have no impact on the exposure due to drinking water. The exposure estimates for all population subgroups when compared to the RfD of 0.46 mg/kg bw/day were at or below 0.3% (non-nursing infants) of the chronic RfD.

      iii. Aggregate dietary.  The aggregate exposure estimate due to food and water in the diet for children 1-2 years old, the most highly exposed subpopulation, was 0.004314 mg/kg bw/day or less than 1% of the chronic RfD.

	2. Non-dietary exposure.  Residential aggregate exposure assessments are not required because the only source of potential imazapic exposure in the U.S. is via the diet and drinking water.

D. Cumulative Effects.

      Imazapic belongs to the imidazolinone class of compounds a class comprised of a number of registered herbicides.  The herbicidal activity of the imidazolinones is due to the inhibition of acetohydroxyacid synthase (AHAS), an enzyme only found in plants.  AHAS is part of the biosynthetic pathway leading to the formation of branched chain amino acids.  Animals lack AHAS and this biosynthetic pathway.  This lack of AHAS contributes to the low toxicity of the imidazolinone compounds in animals.  We are aware of no information to indicate or suggest that imazapic has any toxic effects on mammals that would be cumulative with those of any other chemical.

E. Safety Determination

	1. U.S. population. Based on the chronic RfD of 0.46 mg/kg bw/day, the proposed sugarcane application, in addition to the existing uses, will utilize a maximum of approximately 1.0% of the RfD.  Exposure estimates for the general U.S. population were only 0.001066 mg/kg/day or 0.23% of the RfD.  Exposure estimates for children 1-2 years old, the most highly exposed subpopulation, were only 0.004314 mg/kg/day or 0.94% of the RfD.  EPA generally has no concern for exposure below 100% of the RfD, which represents the level at or below which daily aggregate dietary exposure over a lifetime will pose no appreciable risks to human health.  The complete and reliable toxicity data, indicating low potential mammalian toxicity and the conservative chronic exposure assumptions support the conclusion that there is a "reasonable certainty of no harm" from aggregate exposure to imazapic residues.

	2. Infants and children. The conservative dietary exposure estimates presented above will utilize 0.50% of the RfD for all infants and 0.94% of the RfD for children 1-2 years old, the most highly exposed population subgroup.  Results from the two-generation reproduction study in rats and the developmental toxicity studies in rabbits and rats indicate no increased sensitivity to developing offspring when compared to parental toxicity.  These results also indicate that imazapic is neither a developmental toxicant nor a teratogen in either the rat or rabbit.  Therefore, an additional safety factor is not warranted, and the RfD of 0.46 mg/kg/day, which utilizes a 300-fold safety factor is appropriate to ensure a reasonable certainty of no harm to infants and children.

F. International Tolerances

	EFSA in its reasoned opinion has recommended 0.01 mg/kg for imported sugarcane treated with Imazapic. There are no Codex tolerances established for imazapic on sugarcane.


[Federal Register Volume 80, Number 166 (Thursday, August 27, 2015)]
[Notices]
[Pages 52071-52073]
[FR Doc No: 2015-21206]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 31766; 812-14372]

The RBB Fund, Inc. and Abbey Capital Limited; Notice of
Application

August 21, 2015.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act and rule 18f-2 under the Act, as well as from certain
disclosure requirements in rule 20a-1 under the Act, Item 19(a)(3) of
Form N-1A, Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and 22(c)(9) of
Schedule 14A under the Securities Exchange Act of 1934, and Sections 6-

07(2)(a), (b), and (c) of Regulation S-X (``Disclosure Requirements'').
The requested exemption would permit an investment adviser to hire and
replace certain sub-advisers without shareholder approval and grant
relief from the Disclosure Requirements as they relate to fees paid to
the sub-advisers.

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    Applicants: The RBB Fund, Inc. (the ``Company''), an open-end
management investment company registered under the Act with multiple
series, and Abbey Capital Limited, an Irish limited liability company
registered as an investment adviser under the Investment Advisers Act
of 1940 (``Abbey Capital'' or the ``Adviser,'' and, collectively with
the Company, the ``Applicants'').
    Filing Dates: The application was filed October 15, 2014, and
amended on March 20, 2015, and June 26, 2015.
    Hearing or Notification of Hearing: An order granting the
application will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on September 14, 2015, and should be accompanied by proof of
service on the applicants, in the form of an affidavit or, for lawyers,
a certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090. Applicants: Abbey Capital
Limited, 1-2 Cavendish Row, Dublin 1, Ireland; and Michael P. Malloy,
Esq., Drinker Biddle & Reath LLP, One Logan Square, Ste. 2000,
Philadelphia, PA 19103-6996.

FOR FURTHER INFORMATION CONTACT: Parisa Haghshenas, Senior Counsel, at
(202) 551-6723, or Holly Hunter-Ceci, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Summary of the Application

    1. The Adviser will serve as the investment adviser to each
Subadvised Series pursuant to an investment advisory agreement with the
Company (the ``Investment Advisory Agreement'').\1\ The Adviser will
provide the Subadvised Series with continuous and comprehensive
investment management services subject to the supervision of, and
policies established by, each Subadvised Series' board of directors
(``Board''). The Advisory Agreement permits the Adviser, subject to the
approval of the Board, to delegate to one or more Sub-Advisers the
responsibility to provide the day-to-day portfolio investment
management of each Subadvised Series, subject to the supervision and
direction of the Adviser.\2\ The primary responsibility for managing
the Subadvised Series will remain vested in the Adviser. The Adviser
will hire, evaluate, allocate assets to and oversee the Sub-Advisers,
including determining whether a Sub-Adviser should be terminated, at
all times subject to the authority of the Board.
---------------------------------------------------------------------------

    \1\ Applicants request relief with respect to the named
Applicants, any future series of the Company and any other existing
or future registered open-end management company or series thereof
that intends to rely on the requested order in the future and that:
(a) Is advised by Abbey Capital or its successor or by any entity
controlling, controlled by, or under common control with Abbey
Capital or its successor (included in the term ``Adviser''); (b)
uses the multi-manager structure described in the application; and
(c) complies with the terms and conditions of the application (any
such series, a ''Subadvised Series''). For purposes of the requested
order, ``successor'' is limited to an entity that results from a
reorganization into another jurisdiction or a change in the type of
business organization.
    \2\ A ``Sub-Adviser'' for a Series is (1) an indirect or direct
``wholly owned subsidiary'' (as such term is defined in the Act) of
the Adviser for that Series, or (2) a sister company of the Adviser
for that Series that is an indirect or direct ``wholly-owned
subsidiary'' (as such term is defined in Section 2(a)(43) of the
Act) of the same company that, indirectly or directly, wholly owns
the Adviser (each of (1) and (2) a ``Wholly-Owned Sub Adviser'' and
collectively, the ``Wholly-Owned Sub-Advisers''), or (3) an
investment sub-adviser for that Series that is not an ``affiliated
person'' (as such term is defined in Section 2(a)(3) of the Act) of
the Series or the Adviser, except to the extent that an affiliation
arises solely because the sub-adviser serves as a sub-adviser to one
or more Series (each a ``Non-Affiliated Sub-Adviser'' and
collectively, the ``Non-Affiliated Sub-Advisers'') .
---------------------------------------------------------------------------

    2. Applicants request an exemption to permit the Adviser, subject
to Board approval, to hire a Non-Affiliated Sub-Adviser or a Wholly-
Owned Sub-Adviser, pursuant to Sub-Advisory Agreements and materially
amend Sub-Advisory Agreements with Non-Affiliated Sub-Advisers and
Wholly-Owned Sub-Advisers without obtaining the shareholder approval
required under section 15(a) of the Act and rule 18f-2 under the
Act.\3\ Applicants also seek an exemption from the Disclosure
Requirements to permit a Subadvised Series to disclose (as both a
dollar amount and a percentage of the Subadvised Series' net assets):
(a) The aggregate fees paid to the Adviser and any Wholly-Owned Sub-
Advisers; (b) the aggregate fees paid to Non-Affiliated Sub-Advisers,
and (c) the fee paid to each Affiliated Sub-Adviser (collectively,
``Aggregate Fee Disclosure'').
---------------------------------------------------------------------------

    \3\ The requested relief will not extend to any sub-adviser,
other than a Wholly-Owned Sub-Adviser, who is an affiliated person,
as defined in section 2(a)(3) of the Act, of the Subadvised Series,
the Company or of the Adviser, other than by reason of serving as a
sub-adviser to one or more of the Subadvised Series (``Affiliated
Sub-Adviser'').
---------------------------------------------------------------------------

    3. Applicants agree that any order granting the requested relief
will be subject to the terms and conditions stated in the Application.
Such terms and conditions provide for, among other safeguards,
appropriate disclosure to Subadvised Series' shareholders and
notification about sub-advisory changes and enhanced Board oversight to
protect the interests of the Subadvised Series' shareholders.
    4. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provisions of the Act, or
any rule thereunder, if such relief is necessary or appropriate in the
public interest and consistent with the protection of investors and
purposes fairly intended by the policy and provisions of the Act.
Applicants believe that the requested relief meets this standard
because, as further explained in the Application, the Investment
Advisory Agreements will remain subject to shareholder approval, while
the role of the Sub-Advisers is substantially equivalent to that of
individual portfolio managers, so that requiring shareholder approval
of Sub-Advisory Agreements would impose unnecessary delays and expenses
on the Subadvised Series. Applicants believe that the requested relief
from the Disclosure Requirements meets this standard because it will
improve the Adviser's ability to negotiate fees paid to the Sub-
Advisers that are more advantageous for the Subadvised Series.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-21206 Filed 8-26-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Pages 22334-22335]
[FR Doc No: 2016-08640]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77575; File No. SR-CBOE-2016-030]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule To Amend the Fees Schedule

April 11, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 1, 2016, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its Fees Schedule. The text of the
proposed rule change is available on the Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's
Office of the Secretary, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change 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. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Exchange proposes to amend its Fees Schedule, effective April
1, 2016. Specifically, the Exchange proposes to extend the current
waiver of the VIX Index License Surcharge of $0.10 per contract for
Clearing Trading Permit Holder Proprietary (``Firm'') (origin codes
``F'' or ``L'') VIX orders that have a premium of $0.10 or lower and
have series with an expiration of seven (7) calendar days or less. The
Exchange adopted the current waiver to reduce transaction costs on
expiring, low-priced VIX options, which the Exchange believed would
encourage Firms to seek to close and/or roll over such positions close
to expiration at low premium levels, including facilitating customers
to do so, in order to free up capital and encourage additional trading.
The Exchange initially proposed to waive the surcharge through March
31, 2016, at which time the Exchange stated that it would evaluate
whether the wavier [sic] has in fact prompted Firms to close and roll
over these positions close to expiration as intended. The Exchange
believes the proposed change has in fact encouraged Firms to do so and
as such, proposes to extend the waiver of the surcharge through
December 2016, at which time the Exchange will reevaluate whether the
wavier [sic] has continued to prompt Firms to close and roll over
positions close to expiration at low premium levels. Accordingly, the
Exchange proposes to delete the reference to the current waiver period
of March 31, 2016 from the Fees Schedule and replace it with December
31, 2016.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\3\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \4\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitation
transactions in

securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. Additionally, the Exchange
believes the proposed rule change is consistent with Section 6(b)(4) of
the Act,\5\ which requires that Exchange rules provide for the
equitable allocation of reasonable dues, fees, and other charges among
its Trading Permit Holders and other persons using its facilities.
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(5).
    \5\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes it's reasonable to continue to waive the VIX
Index License Surcharge for Clearing Trading Permit Holder Proprietary
VIX orders that have a premium of $0.10 or lower and have series with
an expiration of 7 calendar days or less because the Exchange wants to
continue encouraging Firms to roll and close over positions close to
expiration at low premium levels. The Exchange notes that without the
waiver, firms are less likely to engage in these transactions, as
opposed to other VIX transactions, due to the associated transaction
costs. The Exchange believes it's equitable and not unfairly
discriminatory to limit the waiver to Clearing Trading Permit Holder
Proprietary orders because they contribute capital to facilitate the
execution of VIX customer orders with a premium of $0.10 or lower and
series with an expiration of 7 calendar days or less. Finally, the
Exchange believes it's reasonable, equitable and not unfairly
discriminatory to provide that the surcharge will be waived through
December 2016, as it gives the Exchange additional time to evaluate if
the wavier [sic] is continuing to have the desired effect of
encouraging these transactions.

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

    The Exchange does not believe that the proposed rule changes will
impose any burden on competition that are not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange does not
believe that the proposed rule change will impose any burden on
intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act because the proposed change
applies to all Firms, and while the waiver only applies to Firm orders,
Firms contribute capital to facilitate the execution of VIX customer
orders with a premium of $0.10 or lower and series with an expiration
of 7 days or less.
    The Exchange does not believe that the proposed rule changes will
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act because the
proposed change only affects trading on CBOE. To the extent that the
proposed changes make CBOE a more attractive marketplace for market
participants at other exchanges, such market participants are welcome
to become CBOE market participants.

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

    The Exchange neither solicited nor received comments on 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 \6\ and paragraph (f) of Rule 19b-4 \7\
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. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2016-030 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-CBOE-2016-030. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2016-030 and should be
submitted on or before May 6, 2016.
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-08640 Filed 4-14-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: August 1, 2006 (Volume 71, Number 147)]
[Notices]
[Page 43545-43547]
[DOCID:fr01au06-98]

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

[Release No. 34-54216; File No. SR-CBOE-2006-58]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of a Proposed Rule Change and Amendment
No. 1 Thereto Regarding DPM and E-DPM Membership Ownership Requirements
and the Ultimate Matching Algorithm

July 26, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on June 14, 2006, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or the ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been substantially
prepared by the Exchange. The CBOE filed Amendment No. 1 to the
proposed rule change on July 18, 2006.\3\ The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 replaced and superseded the original filing
in its entirety.
---------------------------------------------------------------------------

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

    CBOE proposes to amend CBOE Rules relating to membership ownership
requirements. CBOE also proposes to amend the provisions of CBOE Rules
6.45A and 6.45B which provide that a DPM or Lead Market Maker (``LMM'')
utilizing more than one membership in the trading crowd where a class
is traded will count as two market participants for purposes of
Component A of the Ultimate Matching Algorithm (``UMA''). The text of
the proposed rule change is available on the Exchange's Web site
(http://www.cboe.com), at the Office of the Secretary, CBOE and at the

Commission's Public Reference Room.

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

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

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

1. Purpose
    CBOE Rules 8.85 and 8.92 require that a DPM organization and e-DPM
organization, respectively, own a certain number of Exchange
memberships. Specifically, with respect to DPM organizations, CBOE Rule
8.85 requires that each DPM organization own one Exchange membership
for each trading location at which the organization serves as a DPM.
CBOE Rule 8.92 requires that until July 12, 2007, each e-DPM
organization is required to own one Exchange membership for every 30
products allocated to the e-DPM, or lease one Exchange membership for
every 20 products allocated to the e-DPM.\4\
---------------------------------------------------------------------------

    \4\ After July 12, 2007, each e-DPM organization is required to
own one Exchange membership for every 30 products allocated to the
e-DPM.
---------------------------------------------------------------------------

    CBOE proposes to modify these membership ownership requirements in
connection with the Exchange's determination to apply a specific
``appointment cost'' to each options class allocated to a DPM
organization or an e-DPM organization. With respect to DPM
organizations, CBOE Rule 8.85, as proposed to be amended, would require
that each DPM organization own one Exchange membership, and own or
lease such additional Exchange memberships as may be necessary based on
the aggregate ``appointment cost'' for the classes allocated to the DPM
organization. Each membership owned or leased by the DPM organization
would have an appointment credit of 1.0. The appointment costs for the
Hybrid 2.0 Option Classes and the Non-Hybrid Classes allocated to the
DPM organization would be the same as the appointment costs set forth
in CBOE Rule 8.3. The appointment cost for Hybrid Option Classes would
be .01 per class.
    For example, if the DPM organization has been allocated such number
of options classes that its aggregate appointment cost is 1.6, the DPM
organization would be required to own at least one Exchange membership,
and own or lease one additional Exchange membership. As it currently
does for purposes of Remote Market Maker (``RMMs'') and Market-Maker

appointments, the Exchange would rebalance the ``tiers'' set forth in
proposed CBOE Rule 8.3(c)(i), excluding the ``AA'' and ``A+'' tiers,
once each calendar quarter, which could result in additions or
deletions to their composition. When a class changes ``tiers'' it would
be assigned the ``appointment cost'' of that tier. Upon rebalancing,
each DPM organization would be required to own or lease the appropriate
number of Exchange memberships reflecting the revised ``appointment
costs'' of the classes that have been allocated to it. CBOE Rule 8.85
also would provide that a DPM organization is required to own or lease
the appropriate number of Exchange memberships at the time a new
options class allocated to it pursuant to CBOE Rule 8.95 begins
trading.
    Additionally, because member organizations may be approved and
function in a number of capacities at CBOE, including as a DPM
organization, e-DPM organization, and as an RMM, CBOE proposes to allow
the DPM organization to use any excess membership capacity in its
capacity as an RMM or e-DPM. Specifically, in the event the member
organization approved as the DPM organization is also approved to act
as an RMM and/or e-DPM, and has excess membership capacity above the
aggregate appointment cost for the classes allocated to it as the DPM,
the member organization would be permitted to utilize the excess
membership capacity to quote electronically in an appropriate number of
Hybrid 2.0 Classes in the capacity of an RMM and not trade in open
outcry, or to quote electronically in the Hybrid 2.0 Classes in which
it is appointed an e-DPM. For example, if the DPM organization has been
allocated such number of option classes that its aggregate appointment
cost is 1.6, the member organization could request an appointment as an
RMM in any combination of Hybrid 2.0 Classes whose aggregate
``appointment cost'' does not exceed .40. The member organization would
not function as a DPM in any of these additional classes. In the event
the member organization utilizes any excess membership capacity to
quote electronically in some additional Hybrid 2.0 Classes as an RMM or
e-DPM, it would be required to comply with the provisions of CBOE Rules
8.4(c) and Rule 8.93(vii), respectively.
    With respect to e-DPMs, CBOE Rule 8.92, as proposed to be amended,
would require that each e-DPM organization own one Exchange membership,
and own or lease such additional Exchange memberships as may be
necessary based on the aggregate ``appointment cost'' for the classes
allocated to the e-DPM organization. Each membership owned or leased by
the e-DPM organization would have an appointment credit of 1.0. The
appointment costs per Hybrid 2.0 Class, which are categorized by
``tiers'', would be identical to the tiers and appointment costs set
forth in CBOE Rules 8.3(c)(i) and 8.4(d) that have been structured for
purposes of RMMs and Market Maker appointments.
    If the e-DPM organization has been allocated such number of option
classes that its aggregate appointment cost is 6.6, the e-DPM
organization would be required to own at least one Exchange membership,
and own or lease six additional Exchange memberships. The Exchange
would rebalance the ``tiers'' (excluding the ``AA'' and ``A+'' tiers)
once each calendar quarter, which could result in additions or
deletions to their composition. When a class changes ``tiers'' it would
be assigned the ``appointment cost'' of that tier. Upon rebalancing,
each e-DPM organization would be required to own or lease the
appropriate number of Exchange memberships reflecting the revised
``appointment costs'' of the classes that have been allocated to it.
    Similar to DPM organizations, CBOE proposes that in the event the
member organization approved as the e-DPM organization is also approved
to act as an RMM and/or DPM, and has excess membership capacity above
the aggregate appointment cost for the classes allocated to it as the
e-DPM, the member organization would be permitted to utilize the excess
membership capacity to quote electronically in of Hybrid 2.0 Classes in
the capacity of a RMM and not trade in open outcry, and/or to quote
electronically and trade in open outcry in the classes in which it is
appointed a DPM. For example, if the member organization has been
allocated such number of option classes that its aggregate appointment
cost is 6.6, the member organization could request an appointment as an
RMM in any combination of Hybrid 2.0 Classes whose aggregate
``appointment cost'' did not exceed .40. The member organization would
not function as an e-DPM in any of these additional classes. In the
event the member organization utilizes any excess membership capacity
to quote electronically in some additional Hybrid 2.0 Classes as an RMM
or DPM, it would be required to comply with the provisions of CBOE
Rules 8.4(c) and 8.85(a)(v), respectively. In connection with this
change, CBOE proposes to delete the restriction in CBOE Rule 8.92 which
states that memberships used to satisfy the membership ownership
requirements may not be used to comply with the DPM membership
ownership requirement of Rule 8.85(e).
    Finally, CBOE proposes to amend the provisions of CBOE Rules 6.45A
for DPMs and 6.45B for DPMs and LMMs, which provide that a DPM or LMM
utilizing more than one membership in the trading crowd where a class
is traded shall count as two market participants for purposes of
Component A of UMA. Because each membership owned or leased by a DPM
(or LMM) would now have an appointment credit of 1.0, and because each
class in which a DPM (or LMM) has an appointment would have a specific
appointment cost associated with it, CBOE does not believe that
requiring a DPM (or LMM) to utilize a full membership to count as two
market participants for purposes of Component A of UMA is reasonable.
Rather, CBOE believes that it is more appropriate and reasonable to
require that a DPM (or LMM) exclusively use the portion of a
membership(s) representing one-half the total appointment cost of the
classes allocated to the DPM (or, in which the LMM has been appointed)
at a particular trading station in order to count as two market
participants, and not for any other purpose.
    For example, if a DPM's appointment cost is 2.2 for the classes
allocated to it at a particular trading station, pursuant to proposed
amendments to CBOE Rule 8.85(e), the DPM would be required to own one
membership and own or lease two additional memberships. In addition,
the DPM would be permitted to choose to count as two market
participants for purposes of Component A of the Algorithm if the DPM
exclusively utilizes 1.1 (one-half of 2.2) of the membership(s) it owns
or leases in order to count as two market participants, and not utilize
the 1.1 of the memberships for any other purpose. In this example, to
comply with the membership ownership requirements and to count as two
market participants for purposes of Component A, the DPM would be
required to own one membership, and own or lease three additional
memberships to satisfy its total cost of 3.3 (2.2 + 1.1).
    In amending CBOE Rules 6.45A and 6.45B, CBOE proposes to make it
optional for a DPM (or LMM) to choose whether to exclusively use the
portion of its membership(s) representing one-half the total
appointment cost of the classes allocated to the DPM at a particular
trading station in order to count as two market participants, or
instead to use the excess membership

capacity to quote electronically in Hybrid 2.0 Classes.
2. Statutory Basis
    CBOE believes the proposed rule change is consistent with the Act
and the rules and regulations under the Act applicable to a national
securities exchange and, in particular, the requirements of Section
6(b) of the Act.\5\ Specifically, the Exchange believes the proposed
rule change is consistent with the Section 6(b)(5) \6\ requirements
that the rules of an exchange be designed to remove impediments to and
perfect the mechanism for a free and open market and a national market
system, and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2006-58 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2006-58. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the CBOE. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-CBOE-2006-58 and should be submitted on or before August
22, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Lynn Taylor,
Assistant Secretary.
 [FR Doc. E6-12324 Filed 7-31-06; 8:45 am]

BILLING CODE 8010-01-P