[Federal Register: April 19, 2006 (Volume 71, Number 75)]
[Notices]
[Page 20084-20085]
[DOCID:fr19ap06-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application for Amendment of License and Soliciting
Comments, Motions to Intervene, and Protests

April 12, 2006.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Amendment of License.
    b. Project Number: P-1267-075.
    c. Date Filed: March 8, 2006.
    d. Applicant: Greenwood County, South Carolina.
    e. Name of Project: Buzzard's Roost Hydroelectric Project.
    f. Location: The project is located on the Saluda River in
Greenwood, Laurens, and Newberry Counties, South Carolina. The project
does not occupy any Federal or tribal lands.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a) 825(r)
and 799 and 801.
    h. Applicant Contact: Larry Smith, 600 Monument Street, P.O. Box P-
103, Suite 102, Greenwood, SC 29646; phone:<PHONE_NUMBER>.
    i. FERC Contact: Any questions on this notice should be addressed
to Jon Cofrancesco at<PHONE_NUMBER>, or by e-mail:
<EMAIL_ADDRESS>
    j. Deadline for Filing Comments and or Motions: May 3, 2006.
    k. Description of the Application: Greenwood County requests
Commission approval of a proposed change in the location of a public
boat launch facility at Greenwood Lake from a site previously approved
by the Commission in its Order Modifying And Approving Boat Launch
Facility Under Article 416, issued May 11, 2001. Under the Commission
order, the facility was to be installed in Newberry County just east of
the border with Laurens County on Harrington Drive. Greenwood County
now proposes to install the facility in Laurens County on River Fork
Road adjacent to an existing public fishing pier, located southwest of
Waterloo, South Carolina. Greenwood County also requests the Commission
to relieve its obligation to construct a boat launch facility at the
previous location once the facility is completed at the new proposed
site.
    l. Location of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to

be notified via e-mail of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>or for TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', OR ``MOTION TO INTERVENE'', as
applicable, and the Project Number of the particular application to
which the filing refers (P-1267-075). All documents (original and eight
copies) should be filed with: Magalie R. Salas, Secretary, Federal
Energy Regulatory Commission, 888 First Street, NE., Washington DC
20426. A copy of any motion to intervene must also be served upon each
representative of the Applicant specified in the particular
application.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the

Applicant. If an agency does not file comments within the time
specified for filing comments, it will be presumed to have no comments.
One copy of an agency's comments must also be sent to the Applicant's
representatives.
    q. Comments, protests, and interventions may be filed
electronically via the Internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
at http://www.ferc.gov under the ``e-Filing'' link.

Magalie R. Salas,
Secretary.
[FR Doc. E6-5820 Filed 4-18-06; 8:45 am]

BILLING CODE 6717-01-P


Minutes of the

United States Environmental Protection Agency (EPA)

Human Studies Review Board (HSRB)

January 11, 2012 Public Teleconference Meeting

Docket Number: EPA-HQ-ORD-2011-0953

HSRB Website: http://www.epa.gov/osa/hsrb

Committee Members:	(See EPA HSRB Members list – Attachment A)

Date and Time:  	Wednesday, January 11, 2012, 1:00 p.m. – 4:00 p.m.

(See Federal Register Notice – Attachment B)

Location: 	Via teleconference

Purpose: 	The EPA Human Studies Review Board provides advice,
information and recommendations on issues related to the scientific and
ethical aspects of human subjects research.

Attendees: 	Chair: 			Sean Philpott, Ph.D., M.S., Bioethics

Board Members: 	Janice Chambers, Ph.D., D.A.B.T.

George C.J. Fernandez, Ph.D.

Jewell H. Halanych, M.D.

Dallas E. Johnson, Ph.D.

Michael D. Lebowitz, Ph.D., FCCP

Jerry A. Menikoff, M.D.

William J. Popendorf, Ph.D.

Leonard Ritter, Ph.D.

Virginia Ashby Sharpe, Ph.D.

Linda J. Young, Ph.D.

Meeting Summary:	Meeting discussions generally followed the issues and
general timing as presented in the meeting Agenda (Attachment C), unless
noted otherwise in these minutes.

CONVENE MEETING AND IDENTIFICATION OF BOARD MEMBERS

Mr. Jim Downing (Designated Federal Officer [DFO], Human Studies Review
Board [HSRB or Board], Office of the Science Advisor [OSA], U.S.
Environmental Protection Agency [EPA or Agency]) opened the
teleconference meeting and welcomed Board members on behalf of the EPA
Science Advisor Dr. Paul Anastas and the Program in Human Research
Ethics. He noted that the Agency appreciates the Board members’ time
in preparing for the meeting. He also welcomed EPA colleagues and
members of the public. The purpose of this teleconference meeting was to
review the decisions made by the Board at the October 19-20, 2011 HSRB
meeting and to finalize the Board report from that meeting. The October
2011 meeting was the first HSRB meeting to be webcast, and this is an
important tool for providing greater transparency and open government.
The Agency would like feedback from those who attended the webcast;
feedback may be submitted via email to Mr. Downing at
<EMAIL_ADDRESS>

Meeting Administrative Procedures

As DFO, Mr. Downing serves as the liaison between the HSRB and EPA and
ensures that Federal Advisory Committee Act (FACA) requirements are met
with regard to the operations of the HSRB. As DFO, he also works with
the appropriate officials to ensure that all applicable ethics
regulations are satisfied. Each Board member has been briefed on the
provisions of the federal conflict of interest laws and has filed a
standard government financial disclosure form that has been reviewed to
ensure that all ethics disclosure requirements have been met.
Mr. Downing reminded participants that meeting times listed on the
agenda would be approximate, and that Board members should state their
names before speaking. At the teleconference meeting, the Board will
review the draft final report from the October 2011 meeting, and will
finalize the report for submission to the Science Advisor and the
Agency. At the appropriate time, members of the public may provide
public comments; these must be limited to 5 minutes. No individuals
pre-registered to provide public comments.

Copies of the meeting materials are available on regulations.gov under
the docket number EPA-HQ-ORD-2011-0953. According to FACA requirements,
meeting minutes including descriptions of the discussions and
conclusions reached by the Board will be prepared. These minutes will be
certified by the Chair within 90 days of the meeting and posted at
www.regulations.gov and on the HSRB website.

Meeting Process

Dr. Sean Philpott thanked the Board members for their diligent work at
the October 2011 meeting and in completing their sections of the meeting
report, and thanked the Agency staff for their help and comments. He
explained that the Board would discuss the draft Board report, focusing
on the charge questions presented to the Board and the HSRB’s
recommendations. Dr. Philpott requested that the HSRB focus on
substantive changes to the report that directly affect the Board’s
recommendations. Board members should submit any typographical or
grammatical corrections to Dr. Philpott and Mr. Downing via email. He
requested that Board members identify the section of the report to which
they were referring by line number, and to identify themselves before
speaking. The report is intended to be a summary of the HSRB’s
consensus recommendations and not a detailed technical document. The
Agency and study sponsors have access to detailed meeting minutes for
additional information.

	He noted that a number of members of the public were participating in
the teleconference, and that the meeting was being recorded for purposes
of drafting the meeting minutes.

Public Comments

Dr. Philpott invited public comment on the draft October 2011 HSRB
meeting report. No public comments were presented.

Board Discussion and Decision on Final Report

A new scenario design and associated protocol from the Antimicrobial
Exposure Assessment Task Force II (AEATF-II), describing proposed
research to monitor the dermal and inhalation exposure of workers while
pouring liquid antimicrobial pesticide products from both conventional
and reduced-splash containers.

	Dr. Philpott stated that the science charge question was located at
line 315 of the draft report, and asked whether the AEATF liquid pour
study proposal, if revised as suggested in EPA’s review and if the
research is performed as described, would be likely to generate
scientifically reliable data useful for assessing the exposure of
individuals who manually pour liquid antimicrobial products. The Board
concluded that the protocol, as submitted for review and if modified in
accordance with EPA and HSRB recommendations, is likely to generate
scientifically reliable data useful for accessing exposure of
individuals who manually pour liquid antimicrobial products. In addition
to providing several other comments and suggestions, the Board also
pointed out two limitations not identified within the protocol or by the
Agency: the wider range of exposures that could occur when pouring
products outdoors instead of indoors, and the unknown impact of
potential differences in exposures between consumers and professionals.
He asked if any Board members had questions or concerns about this
recommendation and its rationale that begins on line 343. Dr. Linda
Young noted a typographical error on line 364 that created redundancy.
Dr. Philpott agreed to correct it. There were no other comments.

	Dr. Philpott stated the ethics charge question that begins on line 482
asked whether the AEATF liquid pour study proposal, if revised as
suggested in EPA’s review and if the research is performed as
described, would be likely to meet the applicable requirements of 40
Code of Federal Regulations (CFR) part 26, subparts K and L. The Board
concluded that the protocol, as submitted for review and if modified in
accordance with EPA and HSRB recommendations, is likely to meet the
applicable requirements of 40 CFR part 26, subparts K and L. He asked if
any Board members had questions or concerns on the recommendation and
its rationale that begins on line 498. There were no Board comments or
questions.

A new scenario design and associated protocols from the Agricultural
Handler Exposure Task Force (AHETF) describing proposed research to
measure dermal and inhalation exposure to workers who use closed system
equipment to load liquid pesticide products from returnable and
non-returnable containers.

	Dr. Philpott noted that the discussion of the study begins on line 643.
The science charge question begins on line 692 and asked the Board
whether the AHETF closed system loading study proposal, if revised as
suggested in the Agency’s review and if research is performed as
described, would be likely to generate scientifically reliable data,
useful for assessing exposure of workers to closed systems to load
liquid pesticide products from returnable or non-returnable containers.
The Board concurred with the Agency’s assessment that the proposed
AHETF scenario and field study proposal, if revised as suggested and
performed as described, is likely to generate scientifically reliable
data, useful for assessing the exposure of workers using closed systems
to load liquid pesticide products from returnable or non-returnable
containers. The Board raised a number of additional concerns for the
Agency and study sponsors to consider when collecting and analyzing the
exposure data. Those detailed recommendations and suggestions begin on
line 712. He asked if there were any Board questions or concerns about
the recommendations and their rationale. Dr. Young pointed out that the
sentence that begins on line 743 should read “Exposure and normalized
exposure are interpretable only when the proportionality constants are
zero and one.” The word “respectively” should be deleted. Dr.
Philpott agreed to make the change. No other members offered comments.

	Dr. Philpott noted that the ethics charge question was located at line
777, and asked the Board whether the proposed AHETF scenario and field
study proposal, if revised as suggested in EPA’s review and if the
research is performed as described, is likely to meet the applicable
requirements of 40 CFR part 26, subparts K and L. The Board concluded
that the protocol, as submitted for review and if modified in accordance
with EPA and HSRB recommendations, is likely to meet applicable
requirements of 40 CFR part 26, subparts K and L. The Board made a few
additional recommendations that are detailed in lines 793 to 935. He
asked if Board members had any questions or comments regarding the
response to the Agency. No Board members offered comments.

A completed Carroll-Loye Biological Research, Inc. (CLBR) study (No Mas
003) to evaluate the field repellent efficacy against mosquitoes of a
product containing 16% para-methane-3,8-diol (PMD) and 2% lemongrass
oil.

	Dr. Philpott mentioned that Dr. Sidney Green, who was unable to attend
the teleconference meeting, had sent an email noting that on line 955,
there was an error. The line reads “two untreated experienced
volunteers from site 1 also participated as treated controls at site
2.” The sentence should conclude “as treated subjects at site 2,”
and Dr. Philpott has made that change.

	Dr. Philpott stated that the Board’s response to the science charge
question begins on line 997. The Agency asked the Board whether the CLBR
completed study No Mas 003 was sufficiently sound from a scientific
perspective to be used to estimate the duration of complete protection
against mosquitoes provided by the tested repellant. The Board concurred
with the Agency’s assessment that the study provided scientifically
valid results to assess efficacy against mosquitoes for the formulation
tested, and the detailed recommendations and rationale begin on line
1013. Dr. Philpott asked if any Board members had comments regarding the
recommendations and rationale. No Board members offered comments.

	Dr. Philpott stated that the ethics charge question, which begins on
line 1041, asked the Board whether the available information supported a
determination that the study was conducted in substantial compliance
with subparts K and L of 40 CFR part 26. The Board concurred with the
Agency’s assessment that the study submitted for review was conducted
in substantial compliance with subparts K and L of 40 CFR part 26. The
Board’s detailed recommendations and rationale are located on lines
1056 to 1137. He asked if any Board members had comments or concerns
about the recommendations or rationale. No Board members offered
comments.

A published report by Moiemen et al (2011) of an intentional exposure
human study measuring dermal absorption of silver from the use of
nanosilver-containing wound dressings to treat major burns.

	Dr. Philpott noted that the Agency proposed to use the data reported in
the study to make estimates of systemic absorption of silver as a
nanoparticle through the skin. The Board’s consideration of the study
begins on line 1140. He also noted that this is a “post-rule”
published study, so there are different considerations for the level of
information that needs to be provided to the Board. EPA asked the Board
to consider two science charge questions that begin on line 1180: Is the
Moiemen et al study scientifically sound, providing reliable data? If
so, can the Moiemen et al study be used to support the Agency’s
conclusion that the dermal absorption factor for silver from nanosilver
on human skin is less than 0.1 percent? The Board concluded that despite
several deficiencies identified in the study design, the small number of
subjects and the interpretation of the data, it agreed overall with the
Agency’s assessment that the Moeimen et al study provided some
potentially useful baseline information on dermal absorption of silver
from nanosilver-containing wound dressings. The Board also concluded
that the Moiemen et al study could be used to support the Agency’s
conclusion that the dermal absorption for silver from nanosilver was
less than 0.1 percent as part of an overall weight of evidence. The
Board, however, recommended that the Agency clarify its assumptions in
estimating the dermal absorption of silver from nanosilver, and that the
Agency consider alternatives for estimating dermal absorption based on
the study. The Board’s recommendations and rationale begin on line
1210 and continue to line 1286. Dr. Philpott commented that Dr. William
Popendorf also had submitted a statement to the Agency proposing some
alternative approaches for estimating dermal absorption based on this
study. Dr. Philpott asked if any Board members had questions or comments
about the recommendations and rationale. No members offered comments.

	The ethics charge to the Board on the Moiemen et al study asked the
Board to consider whether there was adequate information to support a
determination that the study was conducted in substantial compliance
with procedures at least as protective as those in subparts A through L
of 40 CFR part 26. The Board concurred with the Agency’s assessment
that there was sufficient information regarding the value of the
research to society, subject selection, risks and benefits, independent
ethics review, informed consent and respect for potential and enrolled
subjects to conclude that the study was conducted in substantial
compliance with procedures at least as protective as the relevant
subparts of 40 CFR part 26. The Board’s detailed recommendations and
rationale begin on line 1306 and continue to line 1380. He asked if any
Board members had questions or comments on the recommendations and
rationale. No members offered comments.

Summary and Next Steps

Dr. Philpott commented that the lack of comments reflects well-written
discussions submitted for inclusion in the report, and the high-quality
of both the sponsors’ submissions and the Agency’s review. He
thanked both the Agency and the sponsors for their hard work.
Dr. Michael Lebowitz stated that it was surprising, given the
complicated nature of these studies, that the Board has conducted the
review so well. As a longtime member of the Board, he was very impressed
by the Board’s review at the October 2011 meeting and the Agency’s
review. Dr. Philpott asked if the Agency representatives on the call
had any questions, and they did not. He asked that the Board move to the
procedural vote to approve the final draft pending the modifications
discussed during the teleconference. Dr. Philpott called on each member
in turn for a vote, and all members on the call who had attended the
October 2011 meeting voted to approve the report unanimously. New
members Drs. Jewell Halanych and Leonard Ritter abstained from voting
because they had not been members at the time of the October 2011
deliberations.

Mr. Downing thanked the members for a successful meeting and for their
diligent work on the final report. He noted that the next face-to-face
HSRB meeting would be held January 26, 2012, at the EPA Conference
Center at Potomac Yard South in Crystal City, Virginia. He adjourned the
meeting at 1:45 p.m.

Respectfully submitted:

Jim Downing

Designated Federal Officer

Human Studies Review Board

United States Environmental Protection Agency

Certified to be true by:

Sean Philpott, Ph.D., M.S., Bioethics

Chair

Human Studies Review Board

United States Environmental Protection Agency

NOTE AND DISCLAIMER: The minutes of this public teleconference meeting
reflect diverse ideas and suggestions offered by Board members during
the course of deliberations within the meeting. Such ideas, suggestions
and deliberations do not necessarily reflect definitive consensus advice
from the Board members. The reader is cautioned to not rely on the
minutes to represent final, approved, consensus advice and
recommendations offered to the Agency. Such advice and recommendations
may be found in the final report prepared and transmitted to the EPA
Science Advisor following the public meeting.

Attachments

Attachment A 		HSRB Members

Attachment B 		Federal Register Notice Announcing Meeting

Attachment C 		Meeting Agenda

Attachment A

EPA HUMAN STUDIES REVIEW BOARD MEMBERS

Chair

*Sean Philpott, Ph.D., M.S. Bioethics	Term: 3/27/2006-8/31/2012

Director, Research Ethics

The Bioethics Program

Union Graduate College-Mt. Sinai School of Medicine

Schenectady, NY

Vice Chair

*^Rebecca T. Parkin, Ph.D., M.P.H	Term: 10/1/2007-8/31/2013

Professorial Lecturer (EOH)

School of Public Health and Health Services

The George Washington University

Washington, DC

Members

*Janice Chambers, Ph.D., D.A.B.T.	Term: 3/27/2006-8/31/2012

William L. Giles Distinguished Professor

Director, Center for Environmental Health Sciences

College of Veterinary Medicine

Mississippi State University

Mississippi State, MS

*George C.J. Fernandez, Ph.D.	Term: 5/1/2010-8/31/2013

Statistical Training Specialist

SAS Institute, Statistical Training and Technical Services

Sparks, NV

*^Vanessa Northington Gamble, M.D., Ph.D.	Term: 10/19/2009-10/31/2012

University Professor of Medical Humanities

Gelman Library

The George Washington University

Washington, DC

*^Sidney Green, Jr., Ph.D., Fellow ATS	Term: 10/19/2009-10/31/2012

Department of Pharmacology

Howard University College of Medicine

Howard University

Washington, DC

*Jewell H. Halanych, M.D.	Term: 11/14/2011-8/31/2014

Assistant Professor

Department of Medicine

Division of Preventative Medicine

University of Alabama at Birmingham

Birmingham, AL

*Dallas E. Johnson, Ph.D. 	Term: 8/31/2007-8/31/2013

Professor Emeritus

Department of Statistics

Kansas State University

Manhattan, KS

*Michael D. Lebowitz, Ph.D., FCCP	Term: 3/27/2006-8/31/2012

Retired Professor of Public Health

(Epidemiology) & Medicine & Research Professor of Medicine

University of Arizona

Tucson, AZ

*^José E. Manautou, Ph.D.	Term: 5/1/2010-8/31/2013

Associate Professor of Toxicology

Department of Pharmaceutical Sciences

School of Pharmacy, University of Connecticut

Storrs, CT

Jerry A. Menikoff, M.D. 	Term: 3/27/2006-8/31/2012

Director, Office for Human Research Protections

Department of Health and Human Services

Rockville, MD

*William J. Popendorf, Ph.D.	Term: 10/19/2009-10/31/2012

Professor Emeritus

Department of Biology

Utah State University

Logan, UT

*Leonard Ritter, Ph.D.	Term: 11/14/2011-8/31/2014

Professor Emeritus (Toxicology)

School of Environmental Sciences

University of Guelph

Guelph, Ontario, Canada

*^Bernard A. Schwetz, D.V.M., Ph.D.	Term: 11/14/2011-8/31/2014

Retired Director

Office of Human Research Protections

Department of Health and Human Services

Cadott, WI

Virginia Ashby Sharpe, Ph.D.	Term: 5/1/2010-8/31/2013

National Center for Ethics in Health Care

Veterans Health Administration

Department of Veterans Affairs

Washington, DC

*Linda J. Young, Ph.D.	Term: 3/28/2008-8/31/2012

Department of Statistics

Institute of Food and Agricultural Sciences

University of Florida

Gainesville, FL

*Special Government Employee (SGE)

^Not in attendance at the January 11, 2012 teleconference meeting

Attachment B

FEDERAL REGISTER NOTICE ANNOUNCING MEETING

[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]

[Notices]

[Pages 77825-77827]

From the Federal Register Online via the Government Printing Office [
HYPERLINK "http://www.gpo.gov"  www.gpo.gov ]

[FR Doc No: 2011-32060]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2011-0953; FRL-9506-6]

Human Studies Review Board; Notification of a Public Teleconference

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: The EPA Office of the Science Advisor announces a public
teleconference of the HSRB to discuss its draft report from the October
19-20, 2011 HSRB meeting.

DATES: The teleconference will be held on Wednesday, January 11, 2012
from approximately 1 p.m. to approximately 4 p.m. Eastern Time. Comments
may be submitted on or before Wednesday, January 4, 2012.

ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2011-0953, by one of the following methods:

     Internet:   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov : Follow the Web site instructions for
submitting comments.

     Email:   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

     Mail: Environmental Protection Agency, EPA Docket Center EPA/DC,
ORD Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW., Washington,
DC 20460.

     Hand Delivery: The EPA/DC Public Reading Room is located in the EPA
Headquarters Library, Room Number 3334 in the EPA West Building, located
at 1301 Constitution Avenue NW., Washington, DC 20460. The hours of
operation are 8:30 a.m. to 4:30 p.m.

Eastern Time, Monday through Friday, excluding Federal holidays. Please
call<PHONE_NUMBER> or email the ORD Docket at<EMAIL_ADDRESS>for
instructions. Updates to Public Reading Room access are available online
at   HYPERLINK "http://www.epa.gov/epahome/dockets.htm"
http://www.epa.gov/epahome/dockets.htm .

     Instructions: Direct your comments to Docket ID No.
EPA-HQ-ORD-2011-0953. The Agency's policy is that all comments received
will be included in the public docket without change and may be made
available online at   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov , including any personal information
provided, unless the comments includes information claimed to be
Confidential Business Information or other information the disclosure of
which is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  or email. The
 HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov  Web
site is an “anonymous access” system, which means the EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an email comment directly to the EPA
without going through   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov , your email address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the Internet. If you submit an
electronic comment, the EPA recommends that you include your name and
other contact information in the body of your comments and with any disk
or CD-ROM you submit. If the EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, the EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.

FOR FURTHER INFORMATION CONTACT: Any members of the public who wish to
receive further information should contact Jim Downing on telephone
number<PHONE_NUMBER>; fax<PHONE_NUMBER>; email address   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>or Lu-Ann Kleibacker
on telephone number<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email address
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>; mailing address Environmental Protection Agency, Office of the Science
Advisor, Mail Code 8105R, 1200 Pennsylvania Avenue NW., Washington, DC
20460. General information concerning the EPA HSRB can be found on the
EPA Web site at   HYPERLINK "http://www.epa.gov/osa/hsrb"
http://www.epa.gov/osa/hsrb .

SUPPLEMENTARY INFORMATION:

     Location: The meeting will take place via telephone only.

     Meeting access: For information on access or services for
individuals with disabilities, please contact Lu-Ann Kleibacker at least
ten business days prior to the meeting using the information under FOR
FURTHER INFORMATION CONTACT, so that appropriate arrangements can be
made.

     Procedures for providing public input: Interested members of the
public may submit relevant written or oral comments for the HSRB to
consider during the advisory process. Additional information concerning
submission of relevant written or oral comments is provided in section
I, “Public Meeting,” under subsection D, “How May I Participate in
 this Meeting?” of this notice.

I. Public Meeting

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of particular interest to persons who conduct or assess
human studies, especially studies on substances regulated by the EPA, or
to persons who are, or may be required to conduct testing of chemical
substances under the Federal Food, Drug, and Cosmetic Act or the Federal
Insecticide, Fungicide, and Rodenticide Act. Since other entities may
also be interested, the Agency has not attempted to describe all the
specific entities that may be affected by this action. If you have any
questions regarding the applicability of this action to a particular
entity, consult Jim Downing or Lu-Ann Kleibacker listed under FOR
FURTHER INFORMATION CONTACT.

B. How can I access electronic copies of this document and other related
information?

    You may use   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov , or you may access this Federal Register
document via the EPA's Internet site under the “Federal Register”
listings at   HYPERLINK "http://www.epa.gov/fedrgstr"
http://www.epa.gov/fedrgstr .

     Docket: All documents in the docket are listed in the   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, will
be publicly available only in hard copy. Publicly available docket
materials are available either electronically at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  or in hard
copy at the ORD Docket, EPA/DC Public Reading Room. The EPA/DC Public
Reading Room is located in the EPA Headquarters Library, Room Number
3334 in the EPA West Building, located at 1301 Constitution Avenue NW,
Washington, DC 20460; its hours of operation are 8:30 a.m. to 4:30 p.m.
Eastern Time, Monday through Friday, excluding Federal holidays. Please
call<PHONE_NUMBER>, or email the ORD Docket at<EMAIL_ADDRESS>for
instructions. Updates regarding the Public Reading Room access are
available at   HYPERLINK "http://www.epa.gov/epahome/dockets.htm"
http://www.epa.gov/epahome/dockets.htm .

C. What should I consider as I prepare my comments for EPA?

  You may find the following suggestions helpful for preparing your
comments:

     1. Explain your views as clearly as possible.

     2. Describe any assumptions that you used.

     3. Provide copies of any technical information and/or data used
that support your views.

     4. Provide specific examples to illustrate your concerns and
suggest alternatives.

     5. To ensure proper receipt by the EPA, be sure to identify the
docket ID number assigned to this action in the subject line on the
first page of your response. You may also provide the name, date and
Federal Register citation.

D. How may I participate in this meeting?

    You may participate in this meeting by following the instructions in
this section. To ensure proper receipt by the EPA, it is imperative that
you identify Docket ID No. EPA-HQ-ORD-2011-0953 in the subject line on
the first page of your request.

     1. Oral comments. Requests to present oral comments will be
accepted up to and including Wednesday, January 4, 2012. To the extent
that time permits, interested persons who have not pre-registered may be
permitted by the Chair of the HSRB to present oral comments during the
meeting. Each individual or group wishing to make brief oral comments to
the HSRB is strongly advised to submit their request (preferably via
email) to Jim Downing or Lu-Ann Kleibacker under FOR FURTHER INFORMATION
CONTACT no later than noon, Eastern Time, Wednesday, January 4, 2012, in
order to be included on the meeting agenda and to provide sufficient
time for the HSRB Chair and HSRB Designated Federal Official to review
the meeting agenda to provide an

appropriate public comment period. The request should identify the name
of the individual making the presentation and the organization (if any)
the individual will represent. Oral comments before the HSRB are
generally limited to five minutes per individual or organization. Please
note that this includes all individuals appearing either as part of, or
on behalf of, an organization. While it is our intent to hear a full
range of oral comments on the science and ethics issues under
discussion, it is not our intent to permit organizations to expand the
time limitations by having numerous individuals sign up separately to
speak on their behalf. If additional time is available, further public
comments may be possible.

     2. Written comments. Please submit written comments prior to the
meeting. For the HSRB to have the best opportunity to review and
consider your comments as it deliberates on its report, you should
submit your comments at least five business days prior to the beginning
of this teleconference. If you submit comments after this date, those
comments will be provided to the Board members, but you should recognize
that the Board members may not have adequate time to consider those
comments prior to making a decision. Thus, if you plan to submit written
comments, the Agency strongly encourages you to submit such comments no
later than noon, Eastern Time, Wednesday, January 4, 2012. You should
submit your comments using the instructions in section I, under
subsection C, “What Should I Consider as I Prepare My Comments for
EPA?” In addition, the Agency also requests that persons submitting
comments directly to the docket also provide a copy of their comments to
Jim Downing or Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION
CONTACT. There is no limit on the length of written comments for
consideration by the HSRB.

E. Background

   The HSRB is a Federal advisory committee operating in accordance with
the Federal Advisory Committee Act 5 U.S.C. App.2 section 9. The HSRB
provides advice, information, and recommendations to EPA on issues
related to scientific and ethical aspects of human subjects research.
The major objectives of the HSRB are to provide advice and
recommendations on: (1) Research proposals and protocols; (2) reports of
completed research with human subjects; and (3) how to strengthen EPA's
programs for protection of human subjects of research. The HSRB reports
to the EPA Administrator through the EPA Science Advisor.

     1. Topics for Discussion. The HSRB will be reviewing its draft
report from the October 19-20, 2011, HSRB meeting. The Board may also
discuss planning for future HSRB meetings. Background on the October
19-20, 2011 HSRB meeting can be found at the HSRB Web site:   HYPERLINK
"http://www.epa.gov/osa/hsrb"  http://www.epa.gov/osa/hsrb . The October
19-20, 2011 meeting draft report is now available. You may obtain
electronic copies of this document, and certain other related documents
that might be available electronically, from   HYPERLINK
"http://www.regulations.gov/regulations.gov"  regulations.gov  Web site
and the HSRB Web site at   HYPERLINK "http://www.epa.gov/osa/hsrb"
http://www.epa.gov/osa/hsrb . For questions on document availability or
if you do not have Internet access, consult the persons listed under FOR
FURTHER INFORMATION CONTACT.

     2. Meeting minutes and reports. Minutes of the meeting, summarizing
the matters discussed and recommendations, if any, made by the advisory
committee regarding such matters, will be released within 90 calendar
days of the meeting. Such minutes will be available at   HYPERLINK
"http://www.epa.gov/osa/hsrb/"  http://www.epa.gov/osa/hsrb/  and
HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov . In
addition, information regarding the Board's final meeting report will be
found at   HYPERLINK "http://www.epa.gov/osa/hsrb"
http://www.epa.gov/osa/hsrb  or from the persons listed under FOR
FURTHER INFORMATION CONTACT.

    Dated: December 7, 2011.

Paul T. Anastas,

EPA Science Advisor.

[FR Doc. 2011-32060 Filed 12-13-11; 8:45 am]

BILLING CODE 6560-50-P

Attachment C

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

PUBLIC TELECONFERENCE MEETING AGENDA

Wednesday, January 11, 2012

1:00 pm - 4:00 pm (Eastern Time)*

HSRB MEETING FOR REVIEW AND APPROVAL OF THE DRAFT OCTOBER 19-20, 2011
HSRB MEETING REPORT

HSRB Website:  HYPERLINK "http://www.epa.gov/osa/hsrb/" \h
http://www.epa.gov/osa/hsrb/

Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA–HQ–ORD–2011–0953

1:00 PM	Convene Meeting and Identification of Board Members – Jim
Downing 	(Designated Federal Officer, HSRB, OSA, EPA)

1:10 PM*	Meeting Administrative Procedures – Jim Downing (DFO)

1:15 PM	Meeting Process – Sean Philpott, Ph.D. (HSRB Chair)

1:20 PM	Public Comments

1:30 PM	Board Discussion and Decision on Final Report – Sean Philpott,
Ph.D. (HSRB Chair)

The Board’s response to EPA charge questions presented at the October
19-20, 2011 meeting.

A new scenario design and associated protocol from the Antimicrobial
Exposure Assessment Task Force II (AEATF-II), describing proposed
research to monitor the dermal and inhalation exposure of workers while
pouring liquid antimicrobial pesticide products from both conventional
and reduced-splash containers.

Charge to the Board:

If the AEATF liquid pour study proposal is revised as suggested in
EPA’s review and if the research is performed as described:

Is the research likely to generate scientifically reliable data, useful
for assessing the exposure of individuals who manually pour liquid
antimicrobial products?

Is the research likely to meet the applicable requirements of 40 CFR
part 26, subparts K and L?

A new scenario design and associated protocols from the Agricultural
Handler Exposure

Task Force (AHETF) describing proposed research to measure dermal and
inhalation exposure to workers who use closed system equipment to load
liquid pesticide products from returnable and non-returnable containers.

Charge to the Board:

If the AHETF closed system liquid loading study proposal is revised as
suggested in EPA’s review and if the research is performed as
described:

Is the research likely to generate scientifically reliable data, useful
for assessing the exposure of workers using closed systems to load
liquid pesticide products from returnable or non-returnable containers?

Is the research likely to meet the applicable requirements of 40 CFR
part 26, subparts K and L?

A completed Carroll-Loye Biological Research, Inc. (CLBR) study (No Mas
003) to evaluate the field repellent efficacy against mosquitoes of a
product containing 16% para- methane-3,8-diol and 2% lemongrass oil.

Charge to the Board:

Is the CLBR completed study No Mas 003 sufficiently sound, from a
scientific perspective, to be used to estimate the duration of complete
protection against mosquitoes provided by the tested repellent?

Does available information support a determination that the study No Mas
003 was conducted in substantial compliance with 40 CFR part 26,
subparts K and L?

A published report by Moiemen et al (2011) of an intentional exposure
human study measuring dermal absorption of silver from the use of
nanosilver-containing wound dressings to treat major burns.

Charge to the Board:

Is the Moiemen (2011) study scientifically sound, providing reliable
data?

If so, can the Moiemen (2011) study be used to support the Agency's
conclusion that the dermal absorption factor for silver from nanosilver
on human skin is less than 0.1%?

Is there adequate information to support a determination that the study
was conducted in substantial compliance procedures at least as
protective as those at subparts A-L of 40 CFR part 26?

3:55 PM	Summary and Next Steps – Sean Philpott, Ph.D. (HSRB Chair) and
Jim Downing (DFO)

4:00 PM	Adjournment

  PAGE  1


[Federal Register Volume 88, Number 115 (Thursday, June 15, 2023)]
[Notices]
[Pages 39290-39295]
[FR Doc No: 2023-12763]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97693; File No. SR-LTSE-2023-01]

Self-Regulatory Organizations; Long-Term Stock Exchange, Inc.;
Notice of Filing of Amendment No. 2 and Order Granting Accelerated
Approval of a Proposed Rule Change, as Modified by Amendment Nos. 1 and
2, To Establish Listing Standards Related to Recovery of Erroneously
Awarded Incentive-Based Executive Compensation

June 9, 2023.

I. Introduction

    On February 27, 2023, Long-Term Stock Exchange, Inc. (``LTSE'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend LTSE Rule 14.207(f) to establish listing
standards for the recovery of erroneously awarded compensation, as
required by Rule 10D-1 under the Act (``Rule 10D-1''). On March 10,
2023, the Exchange filed Amendment No. 1 to the proposed rule change,
which replaced and superseded the proposed rule change as originally
filed. The proposed rule change, as modified by Amendment No. 1, was
published for comment in the Federal Register on March 17, 2023.\3\ On
April 24, 2023, the Commission extended the time period within which to
approve the proposed rule change, disapprove the proposed rule change,
or institute proceedings to determine whether to approve or disapprove
the proposed rule change.\4\ On June 8, 2023, the Exchange filed
partial Amendment No. 2 to the proposed rule change.\5\ The Commission
is publishing this notice to solicit comments on the proposed rule
change, as modified by Amendment Nos. 1 and 2, from interested persons
and is approving the proposed rule change, as modified by Amendment
Nos. 1 and 2, on an accelerated basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 97123 (March 13,
2023), 88 FR 16487 (``Notice''). No comments were received in
response to this Notice.
    \4\ See Securities Exchange Act Release No. 97365, 88 FR 26349
(April 28, 2023).
    \5\ Amendment No. 2 is available on the Commission's website at
https://www.sec.gov/comments/sr-ltse-2023-01/srltse202301-202019-404742.pdf. In Amendment No. 2, the Exchange amends proposed LTSE
Rule 14.207(f)(10) to (i) provide that the effective date of LTSE
Rule 14.207(f) would be October 2, 2023; (ii) clarify, consistent
with the requirements of Rule 10D-1 and the rule language as
originally proposed, that each listed issuer is required to comply
with its recovery policy for all incentive-based compensation
received (as such term is defined in proposed LTSE Rule14.207(f)(1))
by executive officers on or after October 2, 2023; and (iii)
clarify, consistent with the language of Rule 10D-1, that
notwithstanding the look-back requirements in LTSE Rule 14.207(f), a
company is only required to apply the recovery policy to incentive-
based executive compensation received on or after the effective
date.
---------------------------------------------------------------------------

II. Background and Description of the Proposal, as Modified by
Amendment Nos. 1 and 2

    On October 26, 2022, the Commission adopted final Rule 10D-1 \6\ to
implement section 954 of the Dodd-Frank Wall Street Reform and Consumer
Protection Act of 2010 (``Dodd-Frank Act''), which added section 10D to
the Act. Section 10D of the Act requires the Commission to adopt rules
directing the national securities exchanges to prohibit

the listing of any security of an issuer that is not in compliance with
the requirements of section 10D of the Act. Rule 10D-1 requires
national securities exchanges that list securities to establish listing
standards that require each issuer to adopt and comply with a written
executive compensation recovery policy and to provide the disclosures
required by Rule 10D-1 and in the applicable Commission filings.\7\
Under Rule 10D-1, listed companies must recover from current and former
executive officers incentive-based compensation received during the
three completed fiscal years preceding the date on which the issuer is
required to prepare an accounting restatement.
---------------------------------------------------------------------------

    \6\ 17 CFR 240.10D-1.
    \7\ See Securities Exchange Act Release No. 96159, 87 FR 73076
(November 28, 2022) (``Adopting Release''). Rule 10D-1 requires such
exchange listing rules to be effective no later than one year after
November 28, 2022. Rule 10D-1 further requires that each listed
issuer: (i) adopt the required recovery policy no later than 60 days
following the effective date of the listing standard; (ii) comply
with the recovery policy for all incentive-based compensation
received by executive officers on or after the effective date of the
applicable listing standard; and (iii) provide the required
disclosures on or after the effective date of the listing standard.
---------------------------------------------------------------------------

    As required by Rule 10D-1, the Exchange proposed to amend LTSE Rule
14.207, Obligations for Companies Listed on the Exchange, paragraph
(f), to establish listing standards for the recovery of erroneously
awarded compensation. Proposed LTSE Rule 14.207(f), entitled ``Recovery
of Erroneously Awarded Compensation to Executive Officers'' (the
``Rule''), incorporates the requirements of Rule 10D-1. Specifically,
the Rule would require companies \8\ to adopt a compensation recovery
policy, comply with that policy, and provide the compensation recovery
policy disclosures required by the Rule and in the applicable
Commission filings.\9\
---------------------------------------------------------------------------

    \8\ For purposes of this order, ``companies'' or ``company''
refers to the issuer of a security listed or an issuer who is
applying to list on the Exchange. See, e.g., LTSE Rule 14.002(a)(5).
    \9\ The Exchange proposes to reposition the current text of
paragraph (f) of LTSE Rule 14.207 (Obligation to Pay Fees) into new
paragraph (g) of Rule 14.207.
---------------------------------------------------------------------------

    Proposed LTSE Rule 14.207(f)(2) sets forth the requirements for
companies to adopt, implement and disclose a recovery policy for
incentive-based execution compensation. Specifically, Proposed LTSE
Rule 14.207(f)(2)(A) would require that each company that lists its
securities on the Exchange must adopt and comply with a written policy
providing that the company will recover reasonably promptly the amount
of erroneously awarded incentive-based compensation to any executive
officer in the event that the company is required to prepare an
accounting restatement due to material non-compliance of the company
with any financial reporting requirement under the securities laws,
including any required accounting restatement to correct an error in
previously issued financial statements that is material to the
previously issued financial statements, or that would result in a
material misstatement if the error were corrected in the current period
or left uncorrected in the current period.
    Proposed LTSE Rule 14.207(f)(2)(B) would require that each company
listed on the Exchange disclose its written recovery policy related to
the recovery of erroneously awarded compensation as part of its
reporting obligations to the Commission, as an exhibit to its Annual
Report, and to the Exchange. A company applying for initial listing
must include its written recovery policy as part of its listing
application.
    Proposed LTSE Rule 14.207(f)(3) would provide that the company's
recovery policy must apply to all incentive-based compensation received
by a person: (A) after beginning service as an executive officer of the
company; (B) who served as an executive officer at any time during the
performance period for that incentive-based compensation; (C) while the
company had a class of securities listed on a national securities
exchange or a national securities association; and (D) during the three
completed fiscal years immediately preceding the date that the company
is required to prepare an accounting restatement as described in
paragraph (f) the Rule.\10\ A company's obligation to recover
erroneously awarded compensation is not dependent on if or when the
restated financial statements are filed.
---------------------------------------------------------------------------

    \10\ In addition to the last three completed fiscal years, the
recovery policy must apply to any transition period (that results
from a change in the company's fiscal year) within or immediately
following those three completed fiscal years. However, a transition
period between the last day of the company's previous fiscal year
end and the first day of its new fiscal year that comprises a period
of nine to 12 months would be deemed a completed fiscal year.
---------------------------------------------------------------------------

    Proposed 14.207(f)(4) would provide that, for purposes of
determining the relevant recovery period, the date that a company is
required to prepare an accounting restatement as described in the Rule
is the earlier to occur of: (A) the date the company's board of
directors, a committee of the board of directors, or the officer or
officers of the company authorized to take such action if board action
is not required, concludes, or reasonably should have concluded, that
the company is required to prepare an accounting restatement as
described in the Rule; or (B) the date a court, regulator, or other
legally authorized body directs the company to prepare an accounting
restatement as described in the Rule.
    Proposed LTSE Rule 14.207(f)(5) sets forth requirements for
determining the amount of incentive-based compensation subject to the
company's recover policy. Subparagraph (A) states that the amount of
incentive-based compensation that must be subject to the company's
recovery policy (``erroneously awarded compensation'') is the amount of
incentive-based compensation received that exceeds the amount of
incentive-based compensation that otherwise would have been received
had it been determined based on the restated amounts, and must be
computed without regard to any taxes paid. Subparagraph (B) states
that, for incentive-based compensation based on stock price or total
shareholder return, where the amount of erroneously awarded
compensation is not subject to mathematical recalculation directly from
the information in an accounting restatement: (i) the amount must be
based on a reasonable estimate of the effect of the accounting
restatement on the stock price or total shareholder return upon which
the incentive-based compensation was received; and (ii) the company
must maintain documentation of the determination of that reasonable
estimate and provide such documentation to the Exchange.
    Proposed LTSE Rule 14.207(f)(6) sets forth certain exceptions to
the requirement to recover erroneously awarded compensation. Proposed
LTSE Rule 14.207(f)(6) would provide that companies must recover
erroneously awarded compensation in compliance with its recovery policy
except to the extent that one of the conditions set forth below is met
and the company's Compensation Committee, or in the absence of such a
committee, a majority of the independent directors serving on the
board, has made a determination that recovery would be impracticable.
     The direct expense paid to a third party to assist in
enforcing the policy would exceed the amount to be recovered. Before
concluding that it would be impracticable to recover any amount of
erroneously awarded compensation based on expense of enforcement, the
company must make a reasonable attempt to recover such erroneously
awarded compensation, document such reasonable attempt(s) to recover,
and provide that documentation to the Exchange.
     Recovery would violate home country law where that law was
adopted

prior to November 28, 2022. Before concluding that it would be
impracticable to recover any amount of erroneously awarded compensation
based on violation of home country law, the company must obtain an
opinion of home country counsel, acceptable to the Exchange, that
recovery would result in such a violation, and must provide such
opinion to the Exchange.
     Recovery would likely cause an otherwise tax-qualified
retirement plan, under which benefits are broadly available to
employees of the registrant, to fail to meet the requirements of 26
U.S.C. 401(a)(13) or 26 U.S.C. 411(a) and regulations thereunder.
    Proposed LTSE Rule 14.207(f)(7) would provide that a company is
prohibited from indemnifying any executive officer or former executive
officer against the loss of erroneously awarded compensation.
    Proposed LTSE Rule 14.207(f)(8) would provide that companies are
required to file all disclosures with respect to their recovery policy
in accordance with the requirements of the federal securities laws,
including the disclosure required by applicable Commission filings, and
the rules of the Exchange.
    Proposed LTSE Rule 14.207(f)(9) would provide that the requirements
of the Rule do not apply to the listing of any security issued by a
unit investment trust as defined in 15 U.S.C 80a-4(2) and any security
issued by a management company as defined in 15 U.S.C. 80(a)-4(3) that
is registered under section 8 of the Investment Company Act of 1940 (15
U.S.C. 80a-8) if such management company has not awarded incentive-
based compensation to any executive officer of the company in any of
the last three fiscal years or, in the case of a company that has been
listed less than three fiscal years, since the listing of the company.
    Proposed LTSE Rule 14.207(f)(1) would provide that, unless the
context otherwise requires, the following definitions apply for
purposes of the Rule (and only for purposes of LTSE Rule 14.207(f)):
     Executive Officer: An executive officer is the company's
president, principal financial officer, principal accounting officer
(or if there is no such accounting officer, the controller), any vice-
president of the company in charge of a principal business unit,
division, or function (such as sales, administration, or finance), any
other officer who performs a policy-making function, or any other
person who performs similar policy-making functions for the company.
Executive officers of the company's parent(s) or subsidiaries are
deemed executive officers of the company if they perform such policy
making functions for the company. In addition, when the company is a
limited partnership, officers or employees of the general partner(s)
who perform policy-making functions for the limited partnership are
deemed officers of the limited partnership. When the company is a
trust, officers, or employees of the trustee(s) who perform policy-
making functions for the trust are deemed officers of the trust.
Policy-making function is not intended to include policy-making
functions that are not significant. Identification of an executive
officer for purposes of the Rule would include at a minimum executive
officers identified pursuant to 17 CFR 229.401(b).
     Financial reporting measures: Financial reporting measures
are those that are determined and presented in accordance with the
accounting principles used in preparing the company's financial
statements, and any measures that are derived wholly or in part from
such measures. Stock price and total shareholder return are also
financial reporting measures. A financial reporting measure need not be
presented within the financial statements or included in a filing with
the Commission.
     Incentive-based compensation: Incentive-based compensation
is any compensation that is granted, earned, or vested based wholly or
in part upon the attainment of a financial reporting measure.
     Received: Incentive-based compensation is deemed received
in the company's fiscal period during which the financial reporting
measure specified in the incentive-based compensation award is
attained, even if the payment or grant of the incentive-based
compensation occurs after the end of that period.
    Proposed LTSE Rule 14.207(f)(10) would provide that the effective
date of the Rule (``effective date'') is October 2, 2023, and that each
company is required to (i) adopt a policy governing the recovery of
erroneously awarded compensation as required by the Rule no later than
60 days following October 2, 2023; (ii) comply with its recovery policy
for all incentive-based compensation received (as such term is defined
in Rule 14.207(f)(1)) by executive officers on or after October 2,
2023; and (iii) provide the disclosures required by the Rule and in the
applicable Commission filings on or after October 2, 2023.\11\ Proposed
LTSE Rule 14.701(f)(10) also states that notwithstanding the look-back
requirement in proposed Rule 14.207(f), a company is only required to
apply the recovery policy to incentive-based compensation received on
or after October 2, 2023.\12\
---------------------------------------------------------------------------

    \11\ See Amendment No. 2, supra note 5. In support of proposing
an effective date of October 2, 2023, the Exchange states it
believes this is consistent with section 10D ``and the goal of
implementing the proposed rule promptly while also being consistent
with the expectations of listed issuers that the proposed rules
would take effect a year after the adoption of SEC Rule 10D-1 based
on the issuers' understanding of a statement made . . . in the
Adopting Release.'' See id.
    \12\ See Amendment No. 2, supra note 5. As described above, a
LTSE listed company would have to comply with its recovery policy
for all incentive-based compensation received by executive officers
on or after the effective date of the applicable listing standard
(i.e., LTSE Rule 14.207(f)). Incentive-based compensation that is
the subject of a compensation contract or arrangement that existed
prior to the effective date of Rule 10D-1 would still be subject to
recovery under the Exchange's rule if such compensation was received
after the effective date of the Rule, as required by Rule 10D-1. See
Adopting Release, supra note 6, and also definitions of ``incentive
based compensation'' and ``received'' in proposed LTSE Rule
14.207(f)(1).
---------------------------------------------------------------------------

    LTSE also proposes an additional clarifying change to LTSE Rule
14.203 (Prerequisites for Applying to List on the Exchange) to make
clear that any company applying to list on LTSE must comply with the
requirements of proposed LTSE Rule 14.207(f).\13\
---------------------------------------------------------------------------

    \13\ See proposed LTSE Rule 14.203(j). See also Notice, supra
note 3, 88 FR at 16487.
---------------------------------------------------------------------------

    LTSE states that the new requirements described above will help
foster effective oversight of executive compensation and provide
increased accountability and transparency to investors by not allowing
executive officers to retain compensation that they were awarded
erroneously.\14\
---------------------------------------------------------------------------

    \14\ See Notice, supra note 3, 88 FR at 16490.
---------------------------------------------------------------------------

    As described above, Rule 10D-1 requires national securities
exchanges to prohibit the initial or continued listing of any security
of an issuer not in compliance with its rules adopted to comply with
Rule 10D-1. LTSE proposes therefore to require that a company will be
subject to delisting if it does not adopt a compensation recovery
policy that complies with the applicable listing standard, disclose the
policy in accordance with Commission rules or comply with its recovery
policy. LTSE states that the process for a company that fails to comply
with proposed LTSE Rule 14.207(f) will follow the established pattern
used for similar corporate governance deficiencies.\15\ Specifically,
LTSE proposes to amend LTSE Rule 14.501(d)(2)(A)(iii) to provide that a
company that fails to comply with proposed LTSE Rule 14.207(f) may

submit to LTSE Regulation \16\ a plan to regain compliance and,
consistent with its process for similar corporate governance
deficiencies, LTSE Staff \17\ may, after review of the compliance plan,
provide the issuer up to 180 days to cure the deficiency.\18\ LTSE Rule
14.501(d)(2)(B) further provides that notifications of deficiencies
that allow for submission of a compliance plan may also result, after
review of the compliance plan, in issuance of a Staff Delisting
Determination or a Public Reprimand Letter. However, LTSE proposes to
amend LTSE Rules 14.501(a)(4), 14.501(d)(4), and 14.502(b)(1)(C) to
provide that a Public Reprimand Letter may not be issued for violations
of proposed LTSE Rule 14.207(f) or of a listing standard required by
Rule 10D-1 or upon appeal of such violations.\19\ If LTSE Staff
provides the issuer with a period to cure the deficiency, and if the
issuer does not regain compliance within the time period provided, LTSE
Staff would be required to issue a Staff Delisting Determination,\20\
which the issuer could appeal to the Listings Review Committee, as
provided in LTSE Rule 14.502. The Listings Review Committee could allow
the issuer up to an additional 180 days to cure the deficiency.\21\
---------------------------------------------------------------------------

    \15\ See id.
    \16\ LTSE Rule 1.160(u) defines the term ``LTSE Regulation'' as
``the department of LTSE or designated employees of LTSE that
supervise, administer, or perform the regulatory functions of LTSE,
including the administration of any regulatory services agreements
with another self-regulatory organization to which LTSE is a
party.''
    \17\ LTSE Rule 14.500(b)(6) defines the term ``Staff'' as
employees of LTSE Regulation.
    \18\ See LTSE Rule 14.501(d)(2)(B).
    \19\ LTSE also proposes to amend the definition of ``Public
Reprimand Letter'' in Rule 14.500(b)(5) to provide that a Public
Reprimand Letter may not be issued for violations of a listing
standard required by Rule 10D-1. Under the existing definition in
LTSE Rule 14.500(b)(5), Public Reprimand Letters can be issued for
violations of LTSE corporate governance or notification listing
standards except for violations of a listing standard required by
Rule 10A-3 of the Act.
    \20\ See LTSE Rule 14.501(d)(2)(E).
    \21\ See LTSE Rule 14.502(b).
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change, as modified by Amendment Nos. 1 and 2, is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to a national securities exchange.\22\ In particular, the
Commission finds that the proposed rule change is consistent with the
requirements of section 6(b) of the Act.\23\ Specifically, the
Commission finds that the proposed rule change is consistent with
section 6(b)(5) of the Act,\24\ which requires, among other things,
that the rules of a national securities exchange be designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, 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, and are not
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers. In addition, the Commission finds that the
proposed rule change is consistent with section 6(b)(7) of the Act,\25\
which requires, among other things, that the rules of a national
securities exchange provide a fair procedure for the prohibition or
limitation by the exchange of any person with respect to access to
services offered by the exchange. The proposed rule change, as modified
by Amendment Nos. 1 and 2, is also consistent with section 10D of the
Act \26\ and Rule 10D-1 thereunder, as further described below.\27\
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78f(b). In approving this proposed rule change,
the Commission has considered the proposed rule change's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \23\ 15 U.S.C. 78f(b).
    \24\ 15 U.S.C. 78f(b)(5).
    \25\ 15 U.S.C. 78(b)(7).
    \26\ 15 U.S.C. 78j-4.
    \27\ 17 CFR 240.10D-1.
---------------------------------------------------------------------------

    The development and enforcement of meaningful listing standards for
a national securities exchange is of substantial importance to
financial markets and the investing public. Meaningful listing
standards are especially important given investor expectations
regarding the nature of companies that have achieved an exchange
listing for their securities, and the role of an exchange in overseeing
its market and assuring compliance with its listing standards.\28\ The
corporate governance standards embodied in the listing rules of
national securities exchanges, in particular, play an important role in
assuring that companies listed for trading on the exchanges' markets
observe good governance practices, including a fair approach and
greater accountability for the recovery of erroneously awarded
compensation.\29\
---------------------------------------------------------------------------

    \28\ See, e.g., Securities Exchange Release Nos. 65708 (November
8, 2011), 76 FR 70799 70802 (November 15, 2011) (SR-NASDAQ-2011-
073); 63607 (December 23, 2010), 75 FR 82420, 82422 (December 30,
2010) (SR-NASDAQ-2010-137); 57785 (May 6, 2008), 73 FR 27597, 27599
(May 13, 2008) (SR-NYSE-2008-17); and 93256 (October 4, 2021), 86 FR
56338 (October 8, 2021) (SR-NASDAQ-2021-007).
    \29\ See, e.g., Securities Exchange Release No. 68639 (January
11, 2013), 78 FR 4570, 4579 (January 22, 2013) (SR-NYSE-2012-49)
(stating, in connection with the modification of exchange rules for
compensation committees of listed issuers to comply with Rule 10C-1
of the Act, that corporate governance listing standards ``play an
important role in assuring that companies listed for trading on the
exchanges' markets observe good governance practices, including a
reasoned, fair, and impartial approach for determining the
compensation of corporate executives'' and stating that the proposal
would foster ``greater transparency, accountability and
objectivity'' in oversight of compensation practices.).
---------------------------------------------------------------------------

    In enacting section 10D of the Act,\30\ Congress resolved to
require national securities exchanges to establish listing standards to
require listed issuers to develop and comply with a policy to recover
incentive-based compensation erroneously awarded on the basis of
financial information that requires an accounting restatement.\31\ In
October 2022, as required by this legislation, the Commission adopted
Rule 10D-1 under the Act, which directs the national securities
exchanges to establish listing standards that require issuers to: (i)
develop and comply with written policies for recovery of incentive-
based compensation based on financial information required to be
reported under the securities laws, applicable to the issuers'
executive officers, during the three completed fiscal years immediately
preceding the date that the issuer is required to prepare an accounting
restatement; and (ii) disclose those compensation recovery policies in
accordance with Commission rules. In response, the Exchange has filed
the proposed rule change, which includes rules intended to comply with
the requirements of Rule 10D-1.
---------------------------------------------------------------------------

    \30\ Public Law 111-203, 954, 124 Stat. 1376, 1904 (2010)
(codified at 15 U.S.C. 78j-4).
    \31\ As a part of the Dodd-Frank Act legislative process, in a
2010 report, the Senate Committee on Banking, Housing and Urban
Affairs stated that it is ``unfair to shareholders for corporations
to allow executive officers to retain compensation that they were
awarded erroneously.'' See Report of the Senate Committee on
Banking, Housing, and Urban Affairs, S.3217, Report No. 111-176 at
135-36 (Apr. 30, 2010) (``Senate Report'') at 135. See also Adopting
Release, supra note 7, 87 FR at 73077 (citing to the Senate Report)
(``The language and legislative history of the Dodd-Frank Act make
clear that section 10D is premised on the notion that an executive
officer should not retain incentive-based compensation that, had the
issuer's accounting been correct in the first instance, would not
have been received by the executive officer, regardless of any fault
of the executive officer for the accounting errors. The Senate
Report also indicates that shareholders should not `have to embark
on costly legal expenses to recoup their losses' and that
`executives must return monies that should belong to the
shareholders.' '').
---------------------------------------------------------------------------

    The Exchange's proposed LTSE Rule 14.207(f) incorporates the
requirements of Rule 10D-1. The Commission

believes that the Exchange's proposal will foster greater fairness,
accountability, and transparency to shareholders of listed issuers by
advancing the recovery of incentive-based compensation that was
erroneously awarded on the basis of financial information that requires
an accounting restatement, consistent with section 10D of the Act \32\
and Rule 10D-1 thereunder,\33\ and will therefore further the
protection of investors consistent with section 6(b)(5) of the Act.\34\
In addition, as the Commission stated in the Adopting Release, the
recovery requirements may provide executive officers with an increased
incentive to take steps to reduce the likelihood of inadvertent
misreporting and will reduce the financial benefits to executive
officers who choose to pursue impermissible accounting methods, which
can further discourage such behavior.\35\ The Commission believes that
these benefits of the Exchange's new rules on the recovery of
erroneously awarded compensation will protect investors and the public
interest as required under section 6(b)(5) of the Act.
---------------------------------------------------------------------------

    \32\ 15 U.S.C. 78j-4.
    \33\ 17 CFR 240.10D-1.
    \34\ 15 U.S.C. 78f(b)(5).
    \35\ See Adopting Release, supra note 7. See also Notice, supra
note 3, 88 FR at 16490, agreeing with the Commission's statement on
the benefits of the recovery policy.
---------------------------------------------------------------------------

    Rule 10D-1 and proposed LTSE Rule 14.207(f) require that a listed
issuer recover the amount of erroneously awarded incentive-based
compensation ``reasonably promptly.'' The Adopting Release stated that
whether an issuer is acting reasonably promptly ``will depend on the
particular facts and circumstances applicable to that issuer'' and
``the final rules do not restrict exchanges from adopting more
prescriptive approaches to the timing and method of recovery under
their rules in compliance with section 19(b) of the Exchange Act . . .
.'' \36\ Rule 10D-1 also does not compel the exchanges to adopt a more
prescriptive approach to the timing and method of recovery. In its
Notice, LTSE stated that ``the [c]ompany's obligation to recover
erroneously awarded incentive-based compensation reasonably promptly
will be assessed on a holistic basis with respect to each such
accounting restatement prepared by the [c]ompany'' and that ``[i]n
evaluating whether the [c]ompany is recovering erroneously-awarded
executive compensation reasonably promptly, the Exchange will consider
whether the [c]ompany is pursuing the appropriate balance of cost and
speed in determining the appropriate means to seek recovery, and
whether the [c]ompany is securing recovery through means that are
appropriate based on the particular facts and circumstances of each
executive officer that owes a recoverable amount.'' \37\ The Commission
believes this guidance provided by the Exchange is consistent with the
Commission's statements regarding when an issuer is acting ``reasonably
promptly'' as expressed in the Adopting Release, with Rule 10D-1 and
with the Act.\38\
---------------------------------------------------------------------------

    \36\ See Adopting Release, supra note 7, 87 FR at 73104. For
example, the Commission stated that after the exchanges have
observed issuer performance they can use any resulting data to
assess the need for further guidelines to ensure prompt and
effective recovery. See id.
    \37\ See Notice, supra note 3, 88 FR at 16489.
    \38\ See Adopting Release, supra note 7, 87 FR 73104.
---------------------------------------------------------------------------

    Rule 10D-1 requires issuers subject to the listing standards to
adopt a recovery policy no later than 60 days following the date on
which the applicable listing standards become effective and to comply
with their recovery policy, and provide the required disclosures, on or
after the effective date. The Exchange, in Amendment No. 2, is
proposing that the effective date of Rule 14.207(f) be October 2,
2023.\39\ The Exchange believes that setting this date as the effective
date will ensure that issuers have more than a year from the date Rule
10D-1 was published in the Federal Register to adopt recovery
policies.\40\ This is consistent with language in Rule 10D-1 and the
Adopting Release, while also ensuring prompt implementation of this
proposed rule.
---------------------------------------------------------------------------

    \39\ See proposed LTSE Rule 14.207(f)(10). See also Amendment
No. 2, supra note 5.
    \40\ Listed issuers will need to have their recovery policy in
place no later than 60 days following the effective date of October
2, 2023, which would be more than a year after publication of Rule
10D-1 in the Federal Register. Listed issuers will also have to
comply with their recovery policy for all incentive-based
compensation received by executive officers on or after the
effective date of October 2, 2023, and provide the required
disclosures in the applicable Commission filings on or after the
effective date of October 2, 2023. See Adopting Release, supra note
6, and also definitions of ``incentive-based compensation'' and
``received'' in proposed Rule 14.201(f)(1). See also supra notes 11-
12 and accompanying text.
---------------------------------------------------------------------------

    With respect to a listed issuer that fails to comply with proposed
LTSE Rule 14.207(f), the Exchange has proposed to apply its current
procedures applicable to companies with similar corporate governance
deficiencies in addition to prohibiting the use of a Public Reprimand
Letter for violations of a listing standard required by Rule 10D-1.\41\
The Commission believes that these procedures for listed issuers out of
compliance with proposed LTSE Rule 14.207(f), which are consistent with
the procedures for similar corporate governance deficiencies,
adequately meet the mandate of Rule 10D-1 and are consistent with
investor protection and the public interest, since they give a listed
issuer a reasonable time period to cure non-compliance with these
important requirements before the listed issuer will be delisted while
helping to ensure that listed issuers that are non-compliant will not
remain listed for an inappropriate amount of time. Additionally, the
proposed delisting process, including the cure period and the right to
appeal a delisting determination to the Exchange's Listings Review
Committee, is consistent with section 6(b)(7) of the Act in that it
provides a fair procedure for the review of delisting determinations
based on violations of the Exchange's rules for recovering erroneous
compensation.
---------------------------------------------------------------------------

    \41\ See supra notes 15-21 and accompanying text.
---------------------------------------------------------------------------

IV. Solicitation of Comments on Amendment No. 2 to the Proposed Rule
Change

    Interested persons are invited to submit written data, views, and
arguments concerning whether the proposed rule change, as modified by
Amendment Nos. 1 and 2, is consistent with the Exchange Act. Comments
may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-LTSE-2023-01 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-LTSE-2023-01. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change 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 website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-LTSE-2023-01, and should be
submitted on or before July 6, 2023.

V. Accelerated Approval of Proposed Rule Change, as Modified by
Amendment Nos. 1 and 2

    The Commission finds good cause to approve the proposed rule
change, as modified by Amendment Nos. 1 and 2, prior to the thirtieth
day after the date of publication of notice of the filing of Amendment
No. 2 in the Federal Register. In Amendment No. 2, the Exchange amended
the proposal to (i) propose that the effective date of LTSE Rule
14.207(f) be October 2, 2023; (ii) clarify, consistent with the
requirements of Rule 10D-1 and the rule language as originally
proposed, that each listed issuer is required to comply with its
recovery policy for all incentive-based compensation received (as such
term is defined in proposed 14.207(f)(1)) by executive officers on or
after October 2, 2023; and (iii) clarify, consistent with the language
of Rule 10D-1, that notwithstanding the look-back requirements in LTSE
Rule 14.207(f), a company is only required to apply the recovery policy
to incentive-based executive compensation received on or after the
effective date.\42\ The changes in Amendment No. 2 provide greater
clarity to the proposal. In addition, the change to the effective date
of the listing standards is consistent with Rule 10D-1 and language in
the Adopting Release. The additional clarifications to Rule
14.207(f)(10) will ensure that the requirements of that Rule conform to
the requirements of Rule 10D-1. Accordingly, the Commission finds good
cause, pursuant to section 19(b)(2) of the Exchange Act,\43\ to approve
the proposed rule change, as modified by Amendment Nos. 1 and 2, on an
accelerated basis.
---------------------------------------------------------------------------

    \42\ See Amendment No. 2, supra note 5.
    \43\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

VI. Conclusion

    It is therefore ordered, pursuant to section 19(b)(2) of the
Act,\44\ that the proposed rule change (SR-LTSE-2023-01), as modified
by Amendment Nos. 1 and 2, be, and hereby is, approved on an
accelerated basis.
---------------------------------------------------------------------------

    \44\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\45\
---------------------------------------------------------------------------

    \45\ 17 CFR 200.30-3(a)(12).

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-12763 Filed 6-14-23; 8:45 am]
BILLING CODE 8011-01-P


		DEPARTMENT OF HEALTH & HUMAN SERVICES			Public Health Service

																			Food and Drug Administration

		Rockville MD 20857

February 20, 2007

Samuel S. Epstein, M.D.

Chairman, Cancer Prevention Coalition

c/o University of Illinois at Chicago School of Public Health

MC922

2121 West Taylor Street

Chicago, IL  60612

Dear Dr. Epstein:

Your petition submitting on requesting the Food and Drug Administration to label milk and other dairy products produced with the us use of Posilac® with a cancer risk warning was received by this office on 02/20/2007.  It was assigned docket number 2007P-0059/CP1 and it was filed on 02/20/2007. Please refer to this docket number in future correspondence on this subject with the Agency.

Please note that the acceptance of the petition for filing is a procedural matter in that it in no way reflects an agency decision on the substantive merits of the petition.

Sincerely,

Lyle D. Jaffe

Division of Dockets Management

Office of Management Programs

Office of Management

cc: Ronnie Cummins

      Organic Consumers Association

      6771 South Silver Hill Drive

      Finland, MN  55603

      John Kinsman

      Family Farm Defenders

      P.O. Box 1772

      Madison, WI  53701

 PAGE   1

 PAGE   2


[Federal Register: September 23, 2009 (Volume 74, Number 183)]
[Notices]
[Page 48615]
[DOCID:fr23se09-120]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60653; File No. SR-NYSE-2009-89]

 Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Proposed Rule Change As Modified by Amendment No. 1
To Amend Certain Corporate Governance Requirements

Correction

    In notice document E9-22392 beginning on page 47831 in the issue of
Thursday, September 17, 2009, make the following correction:
    On page 47837, in the third column, in the 24th line from the top,
``October 5, 2009'' should read ``October 8, 2009''.

[FR Doc. Z9-22392 Filed 9-22-09; 8:45 am]

BILLING CODE 1505-01-D


[Federal Register Volume 77, Number 186 (Tuesday, September 25, 2012)]
[Rules and Regulations]
[Pages 58953-58955]
[FR Doc No: 2012-23495]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2010-0847; FRL-9731-8]

Approval and Promulgation of Air Quality Implementation Plans;
Delaware; Control Technique Guidelines for Plastic Parts, Metal
Furniture, Large Appliances, and Miscellaneous Metal Parts

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving revisions to the Delaware State
Implementation Plan (SIP) submitted by the State of Delaware through
the Delaware Department of Natural Resources and Environmental Control
(DNREC). The revisions amend Delaware's regulation for the Control of
Volatile Organic Compounds (VOC) for sources covered by EPA's Control
Techniques Guidelines (CTG) standards for the following categories:
Plastic Parts, Metal Furniture, Large Appliances, and Miscellaneous
Metal Parts. EPA is approving this SIP revision to meet the
requirements to implement reasonably available control technology
(RACT) controls on emission sources covered by EPA's CTGs in accordance
with the requirements of the Clean Air Act (CAA).

DATES: Effective Date: This final rule is effective on October 25,
2012.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2010-0847. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., 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 either electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State
submittal are available at Delaware Department of Natural Resources and
Environmental Control, 89 Kings Highway, P.O. Box 1401, Dover, Delaware
19903.

FOR FURTHER INFORMATION CONTACT: Gregory Becoat,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On July 13, 2012 (77 FR 41337), EPA published a notice of proposed
rulemaking (NPR) for the State of Delaware. The NPR proposed approval
of the Delaware SIP revision that amends Regulation No. 1124, Control
of Volatile Organic Compounds, sections 2.0 ``Definitions,'' 12.0
``Surface Coating of Plastic Parts,'' 19.0 ``Coating of Metal
Furniture,'' 20.0 ``Coating of Large Appliances,'' and 22.0 ``Coating
of Miscellaneous Metal Parts,'' to incorporate the requirements of
EPA's CTGs. CTGs are documents issued by EPA that provide guidance to
states concerning what types of controls could constitute RACT for VOC
from various sources, including the coating of plastic parts, metal
furniture, large appliances, and miscellaneous metal parts. EPA
requires all ozone nonattainment areas to update regulations for
emission sources covered in an EPA CTG and to submit the regulations to
EPA for approval as SIP revisions. These amendments will reduce the VOC
content of currently regulated coatings, regulate additional coating
categories, require the use of coating application equipment that
provides for high transfer efficiency, and require that clean-up
solvent emissions be included in regulatory applicability
determinations. EPA received no comments on the NPR to approve
Delaware's SIP revision. The formal SIP revision was submitted by the
State of Delaware on April 1, 2010 and March 9, 2012.

II. Summary of SIP Revision

    The SIP revision consists of the following revisions to Delaware's
Regulation No. 1124: (1) Amendments to section 2.0--Definitions, which
adds definitions; (2) amendments to section 12.0--Surface Coating of
Plastic Parts, which establishes applicability for every owner or
operator of any plastic parts or products coating units, adds, revises,
and deletes definitions, specifies standards and exemptions, and
specifies control devices, test methods, compliance certification,
recordkeeping, and reporting requirements; (3) amendments to section
19.0--Coating of Metal Furniture, which establishes applicability to
every owner or operator of any metal furniture coating unit, revises a
definition, specifies standards and exemptions, and specifies control
devices, test methods, compliance certification, recordkeeping, and
reporting requirements; (4) amendments to section 20.0--Coating of
Large Appliances, which establishes

applicability to every owner or operator of any large appliance coating
unit, revises a definition, specifies standards and exemptions, and
specifies control devices, test methods, compliance certification,
recordkeeping, and reporting requirements; and (5) amendments to
section 22.0--Coating of Miscellaneous Metal Parts, which establishes
applicability to every owner or operator of any miscellaneous metal
parts and products coating unit, adds, revises, and deletes
definitions, specifies standards and exemptions, and specifies control
devices, test methods, compliance certification, recordkeeping, and
reporting requirements. Other specific requirements and the rationale
for EPA's proposed action are explained in the NPR and will not be
restated here.

III. Final Action

    EPA is approving as a revision to the Delaware SIP the revisions to
7 DE Administrative Code 1124, sections 2.0, 12.0, 19.0, 20.0, and 22.0
for the control of VOC emissions from plastic parts, metal furniture,
large appliances, and miscellaneous metal parts. This SIP revision
meets the requirements to implement RACT controls on emission sources.

IV. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 CAA. 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 CAA; 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.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 26, 2012. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action.
    This action approving Delaware's control of VOCs from plastic
parts, metal furniture, large appliances, and miscellaneous metal parts
may not be challenged later in proceedings to enforce its requirements.
(See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: September 7, 2012.
Shawn M. Garvin,
Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart I--Delaware

0
2. In Sec.  52.420, the table in paragraph (c) is amended by revising
the entries for Regulation 1124, sections 2.0, 12.0, 19.0, 20.0, and
22.0 to read as follows:

Sec.  52.420  Identification of plan.

* * * * *
    (c) * * *

                                  EPA-Approved Regulations in the Delaware SIP
----------------------------------------------------------------------------------------------------------------
   State regulation (7 DNREC                                 State                                 Additional
             1100)                   Title/subject      effective date     EPA approval date       explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *

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

                               1124 Control of Volatile Organic Compound Emissions
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 2.0...................  Definitions...........         4/11/10  9/25/12 [Insert page    Amended to add
                                                                         number where the        definitions.
                                                                         document begins].

                                                  * * * * * * *
Section 12.0..................  Surface Coating of            10/11/11  9/25/12 [Insert page    ................
                                 Plastic Parts.                          number where the
                                                                         document begins].

                                                  * * * * * * *
Section 19.0..................  Coating of Metal              10/11/11  9/25/12 [Insert page    ................
                                 Furniture.                              number where the
                                                                         document begins].
Section 20.0..................  Coating of Large              10/11/11  9/25/12 [Insert page    ................
                                 Appliances.                             number where the
                                                                         document begins].

                                                  * * * * * * *
Section 22.0..................  Coating of                    10/11/11  9/25/12 [Insert page    ................
                                 Miscellaneous Metal                     number where the
                                 Parts.                                  document begins].

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

* * * * *
[FR Doc. 2012-23495 Filed 9-24-12; 8:45 am]
BILLING CODE 6560-50-P