[Federal Register Volume 79, Number 194 (Tuesday, October 7, 2014)]
[Notices]
[Pages 60572-60573]
[FR Doc No: 2014-23823]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-91]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before October 27, 2014.

ADDRESSES: You may send comments identified by Docket Number FAA-2014-
0732 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.

     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jake Troutman,<PHONE_NUMBER>, 800
Independence Avenue SW., Washington, DC, 20951.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on October 1, 2014.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2014-0732.
    Petitioner: City of Roswell Coalition.
    Section of 14 CFR: Parts 21 Subpart H, 45.23, 61.113(a) and (b),
61.133(a), 91.7(a), 91.9(b)(2) and (c), 91.103, 91.109(a), 91.119,
91.151(a), 91.203(a) and (b), 91.319(a)(1), 91.405(a), 91.407(a)(1),
91.409(a)(2), and 91.417(a).
    Description of Relief Sought: The petitioner, a community based
organization, is seeking an exemption to commercially operate their
Aeryon Labs SkyRanger small unmanned aircraft systems (sUAS) to perform
research and for development and delivery of formally constructed
training curricula to include applications like operations of aerial
inspections and surveys.

[FR Doc. 2014-23823 Filed 10-6-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 57 (Monday, March 25, 2019)]
[Notices]
[Pages 11084-11085]
[FR Doc No: 2019-05629]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:
    Docket Numbers: EG19-69-000.
    Applicants: Glaciers Edge Wind Project, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Glaciers Edge Wind Project, LLC.
    Filed Date: 3/13/19.
    Accession Number: 20190313-5074.
    Comments Due: 5 p.m. ET 4/3/19.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2762-002.
    Applicants: Messer Energy Services, Inc.
    Description: Notice of Non-Material Change in Status of Messer
Energy Services, Inc.
    Filed Date: 3/11/19.
    Accession Number: 20190311-5275.
    Comments Due: 5 p.m. ET 4/1/19.

    Docket Numbers: ER19-1265-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: 20190313 Joint Operating
Agreement--Amendment to be effective 5/13/2019.
    Filed Date: 3/13/19.
    Accession Number: 20190313-5004.
    Comments Due: 5 p.m. ET 4/3/19.

    Docket Numbers: ER19-1266-000.
    Applicants: Calpine Corporation.
    Description: Request for Limited Waiver of Calpine Corporation.
    Filed Date: 3/12/19.
    Accession Number: 20190312-5232.
    Comments Due: 5 p.m. ET 4/2/19.

    Docket Numbers: ER19-1267-000.
    Applicants: Midcontinent Independent System Operator, Inc. Duke
Energy Indiana, LLC.
    Description: Sec.  205(d) Rate Filing: 2019-03-13_SA 3280 DEI-
Roaming Bison Renewables E&P (J754) to be effective 3/14/2019.
    Filed Date: 3/13/19.
    Accession Number: 20190313-5068.
    Comments Due: 5 p.m. ET 4/3/19.

    Docket Numbers: ER19-1268-000.
    Applicants: PacifiCorp.
    Description: Sec.  205(d) Rate Filing: Tri-State NITSA Rev 9 to be
effective 3/1/2019.
    Filed Date: 3/13/19.
    Accession Number: 20190313-5121.
    Comments Due: 5 p.m. ET 4/3/19.

    Docket Numbers: ER19-1269-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-03-13_SA 3263 Diamond
Trail Wind Energy--MidAmerican GIA (J530) to be effective 2/27/2019.
    Filed Date: 3/13/19.
    Accession Number: 20190313-5125.
    Comments Due: 5 p.m. ET 4/3/19.

    Docket Numbers: ER19-1270-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-03-13_SA 3264 Brown
Valley Conductor Clearance MPFCA (J488 J493 J526) to be effective 5/13/
2019.
    Filed Date: 3/13/19.
    Accession Number: 20190313-5127.
    Comments Due: 5 p.m. ET 4/3/19.

    Docket Numbers: ER19-1271-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: Sec.  205(d) Rate Filing: ISO-NE and NEPOOL; Filing re
Significant

Decrease Calculations to be effective 3/14/2019.
    Filed Date: 3/13/19.
    Accession Number: 20190313-5128.
    Comments Due: 5 p.m. ET 4/3/19.

    Docket Numbers: ER19-1278-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: Amended GIA and Distrib Serv
Agmt Johanna Energy Center--Santa Ana Storage Proj to be effective 3/
14/2019.
    Filed Date: 3/13/19.
    Accession Number: 20190313-5137.
    Comments Due: 5 p.m. ET 4/3/19.

    Docket Numbers: ER19-1279-000.
    Applicants: Messer Energy Services, Inc.
    Description: Sec.  205(d) Rate Filing: Notice of Succession to be
effective 3/14/2019.
    Filed Date: 3/13/19.
    Accession Number: 20190313-5149.
    Comments Due: 5 p.m. ET 4/3/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 13, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-05629 Filed 3-22-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48870-48871]
[FR Doc No: 2015-20051]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Science Advisory Board to the National Center for Toxicological
Research Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed to the public.
    Name of Committee: Science Advisory Board (SAB) to the National
Center for Toxicological Research (NCTR).

    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 3, 2015, from
12:30 p.m. to 5 p.m., and November 4, 2015, from 8 a.m. to 5 p.m.
    Location: NCTR SAB, 3900 NCTR Rd., Conference rm. B-12, Jefferson,
AR 72079. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Donna Mendrick, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002,
301-796-8892; or FDA Advisory Committee Information Line, 1-800-741-
8138<PHONE_NUMBER> in the Washington, DC area). A notice in the Federal
Register about last minute modifications that impact a previously
announced advisory committee meeting cannot always be published quickly
enough to provide timely notice. Therefore, you should always check the
Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm
and scroll down to the appropriate advisory committee meeting link, or
call the advisory committee information line to learn about possible
modifications before coming to the meeting.
    Agenda: On November 3, 2015, the SAB Chair will welcome the
participants, and the NCTR Director will provide a Center-wide update
on scientific initiatives and accomplishments during the past year. The
SAB will be presented with an overview of the Division of Biochemistry
Subcommittee and the Subcommittee Site Visit Report. Representatives
from the Office of the Chief Scientist and Office of Medical Products
and Tobacco will discuss research needs and opportunities for
collaborations with NCTR.
    On November 4, 2015, the Center for Drug Evaluation and Research,
Center for Devices and Radiological Health, Center for Biologics
Evaluation and Research, Center for Tobacco Products, Center for
Veterinary Medicine, and Office of Regulatory Affairs will each briefly
discuss their Center-specific research strategic needs. Following the
public session, the SAB will hear an update from each of NCTR's
research divisions.
    Following an open discussion of all the information presented, the
open session of the meeting will close so the SAB members can discuss
personnel issues at NCTR at the end of each day.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: On November 3, 2015, from 12:30 p.m. to 5 p.m., and
November 4, 2015, from 8 a.m. to 4:15 p.m., the meeting is open to the
public. Interested persons may present data, information, or views,
orally or in writing, on issues pending before the committee. Written
submissions may be made to the contact person on or before October 27,
2015. Oral presentations from the public will be scheduled between
approximately 11:45 a.m. and 12:45 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before October 19, 2015. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by October 20, 2015.
    Closed Committee Deliberations: On November 4, 2015, from 4:15 p.m.
to 5 p.m., the meeting will be closed to permit discussion where
disclosure would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). This portion of the meeting will be
closed to permit discussions of information concerning individuals
associated with the research programs at NCTR.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Donna Mendrick at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: August 10, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-20051 Filed 8-13-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 158 (Wednesday, August 17, 2022)]
[Rules and Regulations]
[Pages 50568-50569]
[FR Doc No: 2022-17231]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 800, 801, 808, and 874

[Docket No. FDA-2020-D-1380]

Regulatory Requirements for Hearing Aid Devices and Personal
Sound Amplification Products; Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Regulatory Requirements
for Hearing Aid Devices and Personal Sound Amplification Products.''
This guidance document is intended to describe hearing aids, personal
sound amplification products (PSAPs), their respective intended uses,
and the regulatory requirements that apply to these products. The FDA
Reauthorization Act of 2017 (FDARA) directed FDA to update and finalize
the draft guidance entitled ``Regulatory Requirements for Hearing Aid
Devices and Personal Sound Amplification Products,'' issued on November
7, 2013. This final guidance fulfills this FDARA requirement and
supersedes ``Guidance for Industry and FDA Staff: Regulatory
Requirements for Hearing Aid Devices and Personal Sound Amplification
Products,'' dated February 25, 2009.

DATES: The announcement of the guidance is published in the Federal
Register on August 17, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1380 for ``Regulatory Requirements for Hearing Aid Devices
and Personal Sound Amplification Products.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Regulatory Requirements for Hearing Aid Devices and Personal Sound
Amplification Products'' to the Office of Policy, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: Shu-Chen Peng, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1224, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52)
directs FDA to establish a category of over-the-counter (OTC) hearing
aids through rulemaking, and mandates that FDA establish various
requirements for this category of devices. Published elsewhere in this
edition of the Federal Register, FDA is issuing a final rule (``rule'')
to establish the OTC category of hearing aids and to implement the
requirements of FDARA. In the rule, FDA has also outlined multiple
related changes to the overall regulatory framework for hearing aids to
harmonize existing regulations with the new OTC category while
continuing to provide a reasonable assurance of safety and
effectiveness.
    FDARA also directed FDA to update and finalize the draft guidance
entitled ``Regulatory Requirements for Hearing Aid Devices and Personal
Sound Amplification Products,'' issued on November 7, 2013. To fulfill
this requirement of FDARA, FDA is issuing this final guidance, which
supersedes the February 25, 2009, final guidance. This final guidance
reflects the new regulatory framework for hearing aids in the rule.
    This guidance document identifies current applicable legal
requirements under the Federal Food, Drug, and Cosmetic Act for hearing
aids and for PSAPs. This guidance is intended to describe hearing aids,
PSAPs, their respective intended uses, and the regulatory requirements
that apply to both types of products. For information on certain
situations in which FDA does not intend to enforce certain regulatory
requirements, you may refer to the preamble to the rule that is
published elsewhere in this edition of the Federal Register.
    A notice of availability of the draft guidance appeared in the
Federal Register of October 20, 2021 (86 FR 58192). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including aligning the guidance with the rule.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Regulatory Requirements for Hearing Aid
Devices and Personal Sound Amplification Products.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Regulatory Requirements for Hearing
Aid Devices and Personal Sound Amplification Products'' may send an
email request to [email protected] to receive an electronic
copy of the document. Please use the document number 1832 and complete
title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations have been approved by
OMB as listed in the following table:

----------------------------------------------------------------------------------------------------------------
                     21 CFR part                                        Topic                    OMB control No.
----------------------------------------------------------------------------------------------------------------
807, subpart E.......................................  Premarket notification.................         0910-0120
814..................................................  Premarket approval.....................         0910-0231
800, 801, and 809....................................  Medical Device Labeling Regulations....         0910-0485
803..................................................  Medical Devices; Medical Device                 0910-0437
                                                        Reporting; Manufacturer reporting,
                                                        importer reporting, user facility
                                                        reporting, distributor reporting.
1000 through 1050....................................  Electronic Products....................         0910-0025
----------------------------------------------------------------------------------------------------------------

    Dated: August 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17231 Filed 8-16-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 6 (Wednesday, January 9, 2013)]
[Notices]
[Pages 1855-1856]
[FR Doc No: 2013-00265]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0243; FRL-9374-1]

1-Methyl-3,5,7-Triaza-1-Azoniatricyclodecane Chloride
(Busan1024); Amendment To Terminate Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces EPA's order for the amendment to
terminate uses, voluntarily requested by the registrant and accepted by
the Agency, of products containing the pesticide, Busan 1024, pursuant
to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
This cancellation order follows an August 13, 2008 Federal Register
Notice of Receipt of Request for Amendments to Delete Uses from the
registrant listed in Table 2, to voluntarily amend to terminate uses of
this product registration. This is the last product containing this
pesticide registered for use in the United States. In the August 13,
2008 notice, EPA indicated that it would issue an order implementing
the amendment to terminate uses, unless the Agency received substantive
comments within the 30-day comment period that would merit its further
review of this request, or unless the registrant withdrew the request
within this period. The Agency did not receive any comments on the
notice. Further, the registrant did not withdraw the request.
Accordingly, EPA hereby issues in this notice a cancellation order
granting the requested amendment to terminate uses. Any distribution,
sale, or use of the products subject to this cancellation order is
permitted only in accordance with the terms of this order, including
any existing stocks provisions.

DATES: The cancellations are effective January 9, 2013.

FOR FURTHER INFORMATION CONTACT: Elizabeth Hernandez, Antimicrobials
Division (7510P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action.

B. How can i get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0243, 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.

II. What action is the agency taking?

    This notice announces the amendment to terminate uses, as requested
by the registrant, of a product registered under FIFRA section 3. This
registration is listed in Table 1 of this unit.

         Table 1--1-Methyl-3,5,7-Triaza-1-Azoniatricyclodecane Chloride (Busan1024) Product Cancellation
----------------------------------------------------------------------------------------------------------------
    EPA  Registration No.            Product name                 Company              Uses to be terminated
----------------------------------------------------------------------------------------------------------------
1448-92......................  Busan 1024..............  Buckman Laboratories,     Laundry starch, petroleum
                                                          Inc.                      production and recovery,
                                                                                textiles, papermaking
                                                                                chemicals and coatings,
                                                                                metalworking fluids.
----------------------------------------------------------------------------------------------------------------

    Table 2 of this unit includes the name and address of record for
the registrant of the product in Table 1 of this unit.

         Table 2--Registrant of Cancelled and/or Amended Product
------------------------------------------------------------------------
         EPA Company No.                  Company name and address
------------------------------------------------------------------------
1448.............................  Buckman Laboratories, Inc.
                                   1256 North McLean Blvd.
                                   Memphis, TN 38134.
------------------------------------------------------------------------

III. Summary of Public Comments Received and Agency Response to
Comments

    During the public comment period provided, EPA received no comments
in response to the August 13, 2008 Federal Register notice announcing
the Agency's receipt of the request for voluntary amendment to
terminate uses of Busan 1024.

IV. Cancellation Order

    Pursuant to FIFRA section 6(f), EPA hereby approves the requested
amendment to terminate uses of 1-Methyl-3,5,7-Triaza-1-
Azoniatricyclodecane Chloride (Busan 1024) registration identified in
Table 1 of Unit II. Accordingly, the Agency orders that the product
registration identified in Table 1 of Unit II. is hereby amended to
terminate the affected uses. Any distribution, sale, or use of existing
stocks of the product identified in Table 1 of Unit II. in a manner
inconsistent with any of the Provisions for Disposition of Existing
Stocks set forth in Unit VI. will be considered a violation of FIFRA.

V. What is the agency's authority for taking this action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register. Thereafter,
following the public comment period, the Administrator may approve such
a request.

VI. Provisions for Disposition of Existing Stocks

    The Agency has authorized the registrants to sell or distribute
product under the previously approved labeling for a period of 12
months after approval of the revision, unless other restrictions

have been imposed, as in special review actions.
    EPA's existing stocks policy (56 FR 29362) provides that: ``If a
registrant requests to voluntarily cancel a registration where the
Agency has identified no particular risk concerns, the registrant has
complied with all applicable conditions of reregistration, conditional
registration, and data call ins, and the registration is not subject to
a Registration Standard, Label Improvement Program, or reregistration
decision, the Agency will generally permit a registrant to sell or
distribute existing stocks for 1 year after the cancellation request
was received. Persons other than registrants will generally be allowed
to sell, distribute, or use existing stocks until such stocks are
exhausted.''
    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action. The effective date of this cancellation is January
9, 2013. The cancellation order that is the subject of this notice
includes the following existing stock provisions:
    The registrant may sell and distribute existing stocks of the
product listed in Table 1 until January 9, 2014. Persons other than the
registrant may sell and distribute existing stocks of the product
listed in Table 1 until exhausted. Use of the product listed in Table 1
may continue until existing stocks are exhausted, provided that such
use is consistent with the terms of the previously approved labeling
on, or that accompanied, the canceled product.

List of Subjects

    Environmental protection, Pesticides and pests, Busan 1024, 1-
Methyl-3,5,7-Triaza-1-Azoniatricyclodecane Chloride.

    Dated: December 18, 2012.
Jennifer McLain,
Acting Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. 2013-00265 Filed 1-8-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 9, 2007 (Volume 72, Number 89)]
[Rules and Regulations]
[Page 26300-26304]
[DOCID:fr09my07-10]

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

40 CFR Part 174

[EPA-HQ-OPP-2006-0913; FRL-8124-6]

Bacillus thuringiensis Vip3Aa19 Protein in Cotton; Exemption from
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an extension of the temporary
exemption from the requirement of a tolerance for residues of the
Bacillus thuringiensis Vip3Aa19 protein in cotton when applied/used as
a plant-incorporated protectant (PIP). Syngenta Seeds, Inc. submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
as amended by the Food Quality Protection Act of 1996 (FQPA),
requesting the temporary tolerance exemption. This regulation
eliminates the need to establish a maximum permissible level for
residues of the Bacillus thuringiensis Vip3Aa19 protein in cotton when
applied/used as a PIP on cotton. The temporary tolerance exemption
expires on May 1, 2008.

DATES: This regulation is effective May 9, 2007. Objections and
requests for hearings must be received on or before July 9, 2007, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0913. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The Docket Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Alan Reynolds, 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>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

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

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

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 174 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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-2006-0913 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before July 9, 2007.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0913, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of January 12, 2007 (72 FR 1513) (FRL-8105-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 3G6547) by Syngenta Seeds, Inc., P.O. Box 12257, Research
Triangle Park, NC 27709. The petition requested that 40 CFR 174.452 be
amended by establishing an extension of the temporary exemption from
the requirement of a tolerance for residues of the Bacillus
thuringiensis Vip3A protein when applied/used as a PIP on cotton. This
notice included a summary of the petition prepared by the petitioner
Syngenta Seeds, Inc. No public 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 section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, 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, section 408(b)(2)(D) of FFDCA 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 section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability,
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.

    Data have been submitted demonstrating a lack of mammalian toxicity
at high levels of exposure to the pure (microbially expressed) Vip3Aa19
protein. These data demonstrate the safety of Vip3Aa19 at levels well
above maximum possible exposure levels that are reasonably anticipated
in the crops. This is similar to the Agency position regarding toxicity
and the requirement of residue data for the microbial Bacillus
thuringiensis products from which this PIP was derived (see 40 CFR
158.740(b)(2)(i)). For microbial products, the need for Tier II and III
toxicity testing and residue data to verify the observed effects and
clarify the source of these effects is triggered only by significant
acute effects in studies such as the mouse oral toxicity study.
    In previously submitted Vip3A studies and applications, the
designation VIP3A or Vip3A was used to describe the Vip PIP protein
and/or test material. In the final rule, it is necessary to distinguish
the various Vip3A designations based on the Crickmore Bacillus
thuringiensis Vip3A nomenclature (see http://www.lifesci.sussex.ac.uk/Home/Neil_Crickmore/Bt/
). The original Vip3A toxin as expressed in

COT102 is now known as Vip3Aa19 toxin according to the Crickmore
nomenclature designation. A temporary exemption from the requirement of
a tolerance already has been established for the Bacillus thuringiensis
Vip3A protein and the genetic material necessary for its production in
cotton published in the Federal Register on April 26, 2006 (71 FR
24582) (FRL-7772-7); (40 CFR 174.452). This temporary exemption from
the requirement of a tolerance will be modified to reflect the new
Crickmore designation, Vip3Aa19.
    An acute oral toxicity study was submitted for the Vip3Aa19
protein. Male and female mice (16 of each) were dosed with 3,675
milligrams/kilograms bodyweight (mg/kg bwt) of Vip3Aa19 protein. All
mice survived the study, gained weight, had no test material related
clinical signs, and had no test material related findings at necropsy.
This acute oral toxicity data supports the prediction that the Vip3Aa19
protein would be non-toxic to humans.
    When proteins are toxic, they are known to act via acute mechanisms
and at very low-dose levels (Sjoblad, Roy D., et al. 1992). Therefore,
since no effects were shown to be caused by the PIPs, even at
relatively high-dose levels, the Vip3Aa19 protein is not considered
toxic. Amino acid sequence comparisons showed no similarity between the
Vip3Aa19 protein and known toxic proteins available in public protein
data bases. According to the Codex Alimintarius Commission (Codex)
guidelines, the assessment of potential toxicity also includes
stability to heat (Joint FAO/WHO Food Standard Programme, Codex
Alimentarius Commission, 2003\1\). A heat liability study demonstrated
that Vip3Aa19 is inactivated against fall armyworm when heated to 55
[deg]C for 30 minutes.
---------------------------------------------------------------------------

    \1\ Alinorm 03/34: Joint FAO/WHO Food Standard Programme, Codex
Alimentarius Commission, Twenty-Fifth Session, Rome, Italy 30 June-5
July, 2003. Appendix III, Guideline for the conduct of food safety
assessment of foods derived from recombinant-DNA plants and Appendix
IV, Annex on the assessment of possible allergenicity. Rome, Codex
Alimentarius Commission, 2003. pp. 47-60.
---------------------------------------------------------------------------

    Since Vip3Aa19 is a protein, allergenic sensitivities were
considered. Currently, no definitive tests exist for determining the
allergenic potential of novel proteins. Therefore, EPA uses a weight of
the evidence approach where the following factors are considered:
Source of the trait; amino acid sequence similarity with known
allergens; prevalence in food; and biochemical properties of the
protein, including in vitro digestibility in simulated gastric fluid
(SGF), and glycosylation. This approach was described by the Codex
guidelines for the conduct of food safety assessment of food derived
from recombinant-DNA plants including the assessment of possible
allergenicity in 2003 (Joint FAO/WHO Food Standard Programme, Codex
Alimentarius Commission, 2003).
    Data have been submitted that demonstrate that the Vip3A from
recombinant maize (LPPACHA-0199) and E. coli (VIP3A-0100) proteins are
rapidly degraded by gastric fluid in vitro. (VIP3A-0100 refers to a
microbially expressed Vip3A that has been shown to be the equivalent of
the plant-expressed Vip3A protein.) In a solution of simulated gastric
fluid (containing pepsin) and either 80 [micro]L of LPPACHA-0199 or 320
[micro]L of VIP3A-0100 test protein, both were shown to be susceptible
to pepsin degradation. These data support the conclusion that Vip3A
proteins expressed in transgenic plants will be readily digested as a
conventional dietary protein under typical mammalian gastric
conditions. Further data demonstrate that Vip3Aa19 is not glycoslylated
and a comparison of amino acid sequences of known allergens uncovered
no evidence of any homology with Vip3Aa19, even at the level of eight
contiguous amino acid residues. These data demonstrated that the mean
Vip3Aa19 concentration in cotton seed ranged from ca. 2.51 to 3.23
[micro]g Vip3A/g dry weight. Vip3Aa19 was not detected in cotton fiber
or nectar. Analysis of the refined oil and de-fatted meal by Enzyme-
Linked Immunosorbent Assay (ELISA) detected Vip3Aa19 protein in COT102
meal, but not in oil. Therefore, based on the data provided for the
specific Vip3Aa19 protein, one can conclude that the Vip3Aa19 protein
is present in low levels in cotton seed and not detected in cotton
fiber.
    Therefore, the potential for the Vip3Aa19 protein to be a food
allergen is minimal. As noted in Unit III., toxic proteins typically
act as acute toxins at low-dose levels. Therefore, since no effects
were shown to be caused by this PIP, even at relatively high-dose
levels, the Vip3Aa19 protein is not considered toxic.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA 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).
    The Agency has considered available information on the aggregate
exposure levels of consumers (and major identifiable subgroups of
consumers) to the pesticide chemical residue and to other related
substances. These considerations include dietary exposure under the
tolerance exemption and all other tolerances or exemptions in effect
for the PIP chemical residue, and exposure from non-occupational
sources. Exposure via the skin or inhalation is not likely since the
PIP is contained within plant cells, which essentially eliminates these
exposure routes or reduces these exposure routes to negligible. The
amino acid homology assessment revealed no similarities to known
aeroallergens, indicating that Vip3Aa19 has a low potential to be an
inhalation allergen. It has been demonstrated that there is no evidence
of occupationally related respiratory symptoms, based on a health
survey on migrant workers after exposure to Bacillus thuringiensis
pesticides (Berstein, et al. 1999), which provides further evidence of
the negligible respiratory risks of Bacillus thuringiensis PIPs.
Exposure via residential or lawn use to infants and children is also
not expected because the use sites for the Vip3Aa19 protein are all the
agricultural for control of insects. Oral exposure, at very low levels,
may occur from ingestion of

processed corn products and, theoretically, drinking water.
    However, oral toxicity testing done in rats at a dose in excess of
3 gram(g)/kg showed no adverse effects. Furthermore, the expected
dietary exposure from cotton is several orders of magnitude lower than
the amounts of Vip3Aa19 protein shown to have no toxicity. Therefore,
even if negligible aggregate exposure should occur, the Agency
concludes that such exposure would present no harm due to the lack of
mammalian toxicity and the rapid digestibility demonstrated for the
Vip3Aa19 proteins.

V. Cumulative Effects

    Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered
available information on the cumulative effects of such residues and
other substances that have a common mechanism of toxicity. These
considerations include the cumulative effects on infants and children
of such residues and other substances with a common mechanism of
toxicity. Because there is no indication of mammalian toxicity, the
Agency concludes that there are no cumulative effects arising from
Vip3Aa19 protein residues in cotton.

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

A. Toxicity and Allergenicity Conclusions

    The data submitted and cited regarding potential health effects for
the Vip3Aa19 protein include the characterization of the expressed
Vip3Aa19 protein in cotton, as well as the acute oral toxicity, heat
stability, and in vitro digestibility of the proteins. The results of
these studies were determined applicable to evaluate human risk, and
the validity, completeness, and reliability of the available data from
the studies were considered.
    Adequate information was submitted to show that the Vip3A protein
test material derived from microbial cultures (designated VIP3A-0100)
was biochemically and functionally similar to the Vip3Aa19 protein
expressed in cotton. Microbially produced protein was chosen in order
to obtain sufficient material for testing.
    The acute oral toxicity data submitted supports the prediction that
the Vip3Aa19 protein would be non-toxic to humans. As mentioned Unit
III., when proteins are toxic, they are known to act via acute
mechanisms and at very low dose levels (Sjoblad, Roy D., et al. 1992).
Since no effects were shown to be caused by Vip3Aa19 protein, even at
relatively high dose levels (3,675 mg Vip3Aa19/kg bwt), the Vip3Aa19
protein is not considered toxic. This is similar to the Agency position
regarding toxicity and the requirement of residue data for the
microbial Bacillus thuringiensis products from which this PIP was
derived. (See 40 CFR 158.740(b)(2)(i)). Moreover, Vip3Aa19 showed no
sequence similarity to any known toxin.
    Protein residue chemistry data for Vip3Aa19 were not required for a
human health effects assessment of the subject PIP ingredients because
of the lack of mammalian toxicity. Expression data demonstrated that
mean Vip3Aa19 concentrations in cotton seed ranged from approximately
2.51 to 3.23 [micro]g Vip3Aa19/g dry weight. Vip3Aa19 was not detected
in cotton fiber or nectar. Analysis of the refined oil and de-fatted
meal by ELISA detected Vip3Aa19 protein in COT102 meal, but not in oil.
Therefore, Vip3Aa19 is present in low levels in cotton seed and not
detect in cotton fiber.
    Since Vip3Aa19 is a protein, its potential allergenicity is also
considered as part of the toxicity assessment. Information considered
as part of the allergenicity assessment included data demonstrating
that the Vip3Aa19 protein came from a Bacillus thuringiensis which is
not a known allergenic source, showed no sequence similarity to known
allergens, was readily degraded by pepsin, and was not glycosylated
when expressed in the plant. Therefore, there is a reasonable certainty
that the Vip3Aa19 protein will not be an allergen.
    Neither available information concerning the dietary consumption
patterns of consumers (and major identifiable subgroups of consumers
including infants and children), nor safety factors that are generally
recognized as appropriate for the use of animal experimentation data
were evaluated. The lack of mammalian toxicity at high levels of
exposure to the Vip3Aa19 protein, as well as the minimal potential to
be a food allergen, demonstrate the safety of Vip3Aa19 at levels well
above possible maximum exposure levels anticipated in the crop.
    The genetic material necessary for the production of the PIP active
ingredients are the nucleic acids (DNA, RNA) which comprise genetic
material encoding these proteins and their regulatory regions. The
genetic material (DNA, RNA) necessary for the production of Vip3Aa19
protein already are exempted from the requirement of a tolerance under
a blanket exemption for all nucleic acids (40 CFR 174.475).

B. Infants and Children Risk Conclusions

    Section 408(b)(2)(C) of FFDCA provides that 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) also provides that EPA
shall apply an additional tenfold 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 data base, unless EPA
determines that a different margin of safety will be safe for infants
and children.
    In this instance, based on all the available information, the
Agency concludes that there is a finding of no toxicity for the
Vip3Aa19 protein and the genetic material necessary for its production
in cotton. Because there are no threshold effects of concern, the
Agency has determined that the additional tenfold margin of safety is
not necessary to protect infants and children. Further, the provisions
of consumption patterns, special susceptibility, and cumulative effects
do not apply.

C. Overall Safety Conclusion

    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 the Vip3Aa19 protein and the genetic material
necessary for its production in cotton, when it is applied/used in
accordance with good agricultural practices. This includes all
anticipated dietary exposures and all other exposures for which there
is reliable information. The Agency has arrived at this conclusion
because, as previously discussed, no toxicity to mammals has been
observed, nor has there been any indication of allergenicity potential
for this PIP.

VII. Other Considerations

A. Endocrine Disruptors

    The pesticidal active ingredient is a protein, derived from sources
that are not known to exert an influence on the endocrine system.
Therefore, the Agency is not requiring information on the endocrine
effects of the PIP at this time.

B. Analytical Method(s)

    A method for extraction and ELISA analysis of the Vip3Aa19 protein
in cotton has been submitted and is under review by the Agency. For the
temporary tolerance exemption, the ELISA method described with the
expression data is sufficient.

C. Codex Maximum Residue Level

    No Codex maximum residue levels exist for the PIP Bacillus
thuringiensis Vip3Aa19 protein and the genetic material necessary for
its production in cotton.

VIII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers and food retailers, not States or tribes, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. As such, the Agency has determined that this action
will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, the Agency has determined
that Executive Order 13132, entitled Federalism (64 FR 43255, August
10, 1999) and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000) do not apply to this rule. In addition, this rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 174

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

    Dated: April 26, 2007.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

[PART 174--AMENDED]

0
1. The authority citation for part 174 continues to read as follows:

     Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371.

0
2. Section 174.452 is revised to read as follows:

Sec.  174.452  Bacillus thuringiensis Vip3Aa19 protein in cotton;
temporary exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Vip3Aa19 protein in cotton are
temporarily exempt from the requirement of a tolerance when used as a
plant-incorporated protectant (PIP) in the food and feed commodities of
cotton; vegetative-insecticidal protein in cotton seed, cotton oil,
cotton meal, cotton hay, cotton hulls, cotton forage, and cotton gin
byproducts. This temporary exemption from the requirement of tolerance
will permit the use of the food commodities in this section when
treated in accordance with the provisions of the experimental use
permit (EUP) 67979-EUP-7, which is being issued in accordance with the
provisions of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended (7 U.S.C. 136). This temporary exemption from the
requirement of a tolerance expires and is revoked May 1, 2008. However,
if the EUP is revoked, or if any experience with or scientific data on
this pesticide indicate that the temporary tolerance exemption is not
safe, this temporary exemption from the requirement of a tolerance may
be revoked at any time.
[FR Doc. E7-8951 Filed 5-8-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 82, Number 149 (Friday, August 4, 2017)]
[Rules and Regulations]
[Pages 36333-36335]
[FR Doc No: 2017-16436]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-0677]
RIN 1625-AA00

Safety Zone; Mississippi River; New Orleans, LA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters on the Mississippi River from mile marker (MM) 96 to
MM 96.5 Above Head of Passes. The safety zone is needed to protect
personnel, vessels, and the marine environment from potential hazards
created by a fireworks display. Entry of vessels or persons into this
zone is prohibited unless specifically authorized by the Captain of the
Port, New Orleans (COTP).

DATES: This rule is effective from 7:30 p.m. through 8:30 p.m. on
August 21, 2017.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2017-0677 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander (LCDR) Howard Vacco, Sector New
Orleans, at<PHONE_NUMBER> or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port New Orleans
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. We must
establish this safety zone by August 21, 2017 and we lack sufficient
time to provide a reasonable comment period and then consider those
comments before issuing the rule. It is also contrary to the public
interest as it would delay the safety measures necessary to protect
life and property from the possible hazards associated with the
fireworks display launched from the waterway. The impacts on navigation
are expected to be minimal as the safety zone will only be in effect
for a short duration of one hour. The Coast Guard will notify the
public and maritime community that the safety zone will be in effect
and of its enforcement periods via Broadcast Notice to Mariners (BNM)
and Marine Safety Information Bulletin (MSIB).
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule is contrary to public interest because it would delay the
safety measures necessary to respond to potential safety hazards
associated with the fireworks display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port New Orleans (COTP) has determined that
potential hazards associated with a fireworks display on August 21,
2017 will be a safety concern for anyone on the navigable waterways
within a one-half mile range of the fireworks. This rule is needed to
protect personnel, vessels, and the marine environment in the navigable
waters within the safety zone while the fireworks are being launched.

IV. Discussion of the Rule

    This rule establishes a safety zone from 7:30 p.m. through 8:30
p.m. on August 21, 2017. The safety zone will cover all navigable
waters from mile marker 96 to 96.5 Above Head of Passes on the
Mississippi River. The duration of the zone is intended to protect
personnel, vessels, and the marine environment in these navigable
waters from the hazards of the fireworks. No vessel or person will be
permitted to enter the safety zone without obtaining permission from
the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the safety zone. This safety
zone will impact a small designated area of the Mississippi River for 1
hour. Moreover, the Coast Guard will issue BNMs via VHF-FM Channel 16
about the zone and the rule allows vessels to seek permission to enter
the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this
action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves creating a safety zone lasting one hour that will
prohibit entry and navigating between mile marker 96 to 96.5, Above
Head of Passes on the Mississippi River. It is categorically excluded
from further review under paragraph 34(g) of Figure 2-1 of the
Commandant Instruction. A Record of Environmental Consideration
supporting this determination is available in the docket where
indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T08-0677 to read as follows:

Sec.  165.T08-0677   Safety Zone; Mississippi River, New Orleans, LA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Mississippi River between mile marker 96 and 96.5 Above
Head of Passes.
    (b) Effective period. This rule is effective from 7:30 p.m. through
8:30 p.m. on August 21, 2017.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into this zone is prohibited unless
specifically authorized by the Captain of the Port New Orleans (COTP)
or designated representative. A designated representative is a
commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Sector New
Orleans.
    (2) Vessels requiring entry into this safety zone must request
permission from the COTP or a designated representative. They may be
contacted on VHF-FM Channel 16 or 67.
    (3) Persons and vessels permitted to enter this safety zone must
transit at their slowest safe speed and comply with all lawful
directions issued by the COTP or the designated representative.
    (d) Information broadcasts. The COTP or a designated representative
will inform the public through Broadcast Notices to Mariners of any
changes in the planned schedule.

    Dated: July 31, 2017.
Wayne R. Arguin,
Captain, U.S. Coast Guard, Captain of the Port New Orleans.
[FR Doc. 2017-16436 Filed 8-3-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: December 14, 2009 (Volume 74, Number 238)]
[Notices]
[Page 66188-66190]
[DOCID:fr14de09-105]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61129; File No. SR-BX-2009-080]

 Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Rule 2330 and IM-2330 To Reflect Changes to Corresponding FINRA Rule

December 8, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 4, 2009, NASDAQ OMX BX, Inc. (the ``BX'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I, II, and III below, which Items have
been prepared by the Exchange. The Exchange has designated the proposed
rule change as constituting a non-controversial rule change under Rule
19b-4(f)(6) under the Act,\3\ which renders the proposal effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act''),\4\ and Rule 19b-4 thereunder,\5\ NASDAQ
OMX BX, Inc. (``BX'') is filing with the Securities and Exchange
Commission (``Commission'') a proposed rule change to amend BX Rule
2330 and IM-2330 to reflect recent changes to a corresponding rule of
the Financial Industry Regulatory Authority (``FINRA''). The text of
the proposed rule change is below. Proposed new language is italicized;
proposed deletions are in brackets: NASDAQ OMX BX RULES
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    \4\ 15 U.S.C. 78s(b)(1).
    \5\ 17 CFR 240.19b-4.
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* * * * *

2150. Customers' Securities or Funds

    (a) Exchange Members and persons associated with a member shall
comply with FINRA Rule 2150 as if such Rule were part of the Rules
of the Exchange.
    (b) Nothing in FINRA Rule 2150, as applied to Exchange members
and their associated persons, shall be construed to authorize any
Exchange member or associated person to act in a manner inconsistent
with Section 11(a) of the Act.

IM-2150. Segregation of Customers' Securities

    (a) Exchange Members and persons associated with a member shall
comply with FINRA Interpretive Material 2150 as if such Rule were
part of the Rules of the Exchange.
    (b) For purposes of this Rule, references to Rule 2150 shall be
construed as references to Equity Rule 2150.
* * * * *

[2330. Customers' Securities or Funds

    (a) Exchange Members and persons associated with a member shall
comply with NASD Rule 2330 as if such Rule were part of the Rules of
the Exchange.
    FINRA is in the process of consolidating certain NASD rules into
a new FINRA rulebook. If the provisions of NASD Rule 2330 are
transferred into the FINRA rulebook, then Equity Rule 2330 shall be
construed to require Exchange members and persons associated with a
member to comply with the FINRA rule corresponding to NASD Rule 2330
(regardless of whether such rule is renumbered or amended) as if
such rule were part of the Rules of the Exchange.
    (b) Nothing in NASD Rule 2330, as applied to Exchange members
and their associated persons, shall be construed to authorize any
Exchange member or associated person to act in a manner inconsistent
with Section 11(a) of the Act.]

[IM-2330. Segregation of Customers' Securities

    (a) Exchange Members and persons associated with a member shall
comply with NASD Interpretive Material 2330 as if such Rule were
part of the Rules of the Exchange.
    FINRA is in the process of consolidating certain NASD rules into
a new FINRA rulebook. If the provisions of NASD Interpretive
Material 2330 are transferred into the FINRA rulebook, then Equity
Interpretive Material 2330 shall be construed to require Exchange
members and persons associated with a member to comply with the
FINRA rule corresponding to NASD Interpretive Material 2330
(regardless of whether such rule is renumbered or amended) as if
such rule were part of the Rules of the Exchange.
    (b) For purposes of this Rule, references to Rule 2330 shall be
construed as references to Equity Rule 2330.]
* * * * *

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
    Many of BX's rules are based on rules of FINRA (formerly the
National Association of Securities Dealers (``NASD'')). During 2008,
FINRA embarked on an extended process of moving rules formerly
designated as ``NASD Rules'' into a consolidated FINRA rulebook. In
most cases, FINRA has renumbered these rules, and in some cases has
substantively amended them. Accordingly, BX also proposes to initiate a
process of modifying its rulebook to ensure that BX rules corresponding
to FINRA/NASD rules continue to mirror them as closely as practicable.
In some cases, it will not be possible for the rule numbers of BX rules
to mirror corresponding FINRA rules, because existing or planned BX
rules make use of those numbers. However, wherever possible, BX plans
to update its rules to reflect changes to corresponding FINRA rules.
    This filing addresses BX Rule 2330 entitled ``Customers' Securities
or Funds'' and IM-2330 entitled ``Segregation of Customers'
Securities.'' BX Rule 2330 and IM-2330 both make reference to NASD Rule
2330 entitled ``Improper Use of Customer's Securities or Funds;
Prohibitions Against Guarantees and Sharing in Accounts.'' FINRA filed
a proposed rule change, which will be effective December 14, 2009, to
adopt NASD Rule 2330 as FINRA Rule 2150.\6\ FINRA made minor changes to
Rule 2150, specifically amending 2150(c). FINRA Rule 2150 prohibits
members and associated person from: (a) Making improper use of a
customer's securities or funds; (b) guaranteeing a customer against
loss in connection with any securities transaction or in any securities
account of the customer; and (c) sharing in the profits or losses in
the customer's account except under certain limited conditions
specified in the Rule. In addition, FINRA added Supplementary
Information to Rule 2150 that codifies existing staff guidance
clarifying that: (i) A ``guarantee'' extended to all holders of a
particular security by an issuer as part of that security generally
would not be subject to the prohibition against guarantees and that a
permissible sharing arrangement remains subject to other applicable
FINRA rules; (ii) the rule does not preclude a member from determining
on an after-the-fact basis, to reimburse a customer for transaction
losses, provided however that the member shall comply with all
reporting requirements that may be applicable to such payment; (iii)
the rule does not preclude a member from correcting a bona fide error;
and (iv) the required written authorization(s) shall be preserved for a
period of at least six years after the date the account is closed,
which is consistent with the retention period under the Act for similar
records.
---------------------------------------------------------------------------

    \6\ Securities Exchange Act Release No. 60701 (September 21,
2009), 74 FR 49425 (September 28, 2009) (SR-FINRA-2009-014).
---------------------------------------------------------------------------

    BX is proposing to amend BX Rule 2330 and IM-2330 by renaming Rule
2330 to new Rule 2150 and renaming IM-2330 to new IM-2150, in order to
incorporate by reference the FINRA rule. BX would delete current Rule
2330 and IM-2330. BX also proposes to amend the references to NASD Rule
2330 to instead state FINRA Rule 2150 in the new Rule 2150 and IM-2150
to reflect the change to the FINRA rules.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\7\ in general, and with
Sections 6(b)(5) of the Act,\8\ in particular, in that the proposal is
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 facilitating
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. The proposed
changes will conform BX Rule 2330 and IM-2330 to recent changes made to
a corresponding FINRA rule and rename Rule 2330 and IM-2330 to new Rule
2150 and new IM-2150, to promote application of consistent regulatory
standards.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f.
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(6) thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BX-2009-080.

Paper Comments

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

All submissions should refer to File Number SR-BX-2009-080. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BX-2009-080 and should be
submitted on or before January 4, 2010.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-29649 Filed 12-11-09; 8:45 am]

BILLING CODE 8011-01-P