[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Rules and Regulations]
[Pages 22840-22842]
[FR Doc No: 2018-10389]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0994; Airspace Docket No. 17-ASO-21]
RIN 2120-AA66

Amendment of Class D Airspace and Class E Airspace; Greenwood, MS

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class D airspace, and Class E surface area
airspace at Greenwood-Leflore Airport, Greenwood, MS, by making an
editorial change to the legal descriptions replacing ``Airport-Facility
Directory'' with the term ``Chart Supplement''. This action also
removes the part-time Notice to Airmen (NOTAM) language from Class E
airspace designated as an extension to Class D airspace. Controlled
airspace is necessary for the safety and management of instrument
flight rules (IFR) operations at the airport. This action also updates
the geographic coordinates of the airport in the Class designations
noted in this proposal to coincide with the FAA's aeronautical
database. Also, this action corrects the geographic coordinates
published in the proposal incorrectly.

DATES: Effective 0901 UTC, July 19, 2018. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11B, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Ave, College Park, GA 30337; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class D and Class E airspace at Greenwood-Leflore Airport,
Greenwood, MS, to support IFR operations under standard instrument
approach procedures at the airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (83 FR 5966, February 12, 2018) for Docket No. FAA-2017-0994
to amend Class D airspace, Class E surface airspace, Class E airspace
designated as an extension to a Class D surface area, and Class E
airspace extending upward from 700 feet or more above the surface at
Greenwood-Leflore Airport, Greenwood, MS.
    Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    Class D and E airspace designations are published in paragraph
5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.11B dated
August 3, 2017, and effective September 15, 2017, which is incorporated
by reference in 14 CFR part 71.1. The Class D and E airspace
designations listed in this document will be published subsequently in
the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11B, Airspace Designations and
Reporting Points, dated August 3, 2017, and effective September 15,
2016. FAA Order 7400.11B is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11B lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71 amends Class D airspace, and Class E surface area airspace at
Greenwood-Leflore Airport, Greenwood, MS, by making an editorial change
to the legal descriptions replacing ``Airport-Facility Directory'' with
the term ``Chart Supplement''.
    Also, this action removes the part-time NOTAM language from the
Class E airspace designated as an extension to a Class D surface area.
    Additionally, the geographic coordinates of the airport, in the
above airspace areas, and the Class E airspace area extending upward
from 700 feet above the surface, are adjusted to coincide with the
FAA's aeronautical database.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
only affects air traffic procedures and air navigation, it is certified
that this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.11B, Airspace Designations and Reporting
Points, dated August 3, 2017, effective September 15, 2017, is amended
as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASO MS D Greenwood, MS [Amended]

Greenwood-Leflore Airport, MS
    (Lat. 33[deg]29'36'' N, long. 90[deg]05'12'' W)

    That airspace extending upward from the surface to and including
2,700 feet MSL within a 4.4-mile radius of Greenwood-Leflore
Airport. This Class D airspace area is effective during the specific
dates and times established in advance by a Notice to Airmen. The
effective dates and times will thereafter be continuously published
in the Chart Supplement.

Paragraph 6002 Class E Surface Area Airspace.

* * * * *

ASO MS E2 Greenwood, MS [Amended]

Greenwood-Leflore Airport, MS
    (Lat. 33[deg]29'36'' N, long. 90[deg]05'12'' W)

    Within a 4.4-mile radius of Greenwood-Leflore Airport. This
Class E airspace area is effective during the specific dates and
times established in advance by a Notice to Airmen. The effective
date and time will thereafter be continuously published in the Chart
Supplement.

Paragraph 6004 Class E Airspace Designated as an Extension to a
Class D Surface Area.

* * * * *

ASO MS E4 Greenwood, MS [Amended]

Greenwood-Leflore Airport, MS
    (Lat. 33[deg]29'36'' N, long. 90[deg]05'12'' W)
Sidon VORTAC
    (Lat. 33[deg]27'50'' N, long. 90[deg]16'38'' W)

    That airspace extending upward from the surface within 1.4 miles
each side of the Sidon VORTAC 079[deg] radial, extending from the
4.4-miles radius of Greenwood-Leflore Airport to 4 miles east of the
VORTAC.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO MS E5 Greenwood, MS [Amended]

Greenwood-Leflore Airport, MS
    (Lat. 33[deg]29'36'' N, long. 90[deg]05'12'' W)
Sidon VORTAC
    (Lat. 33[deg]27'50'' N, long. 90[deg]16'38'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.9-mile radius of That That airspace That airspace
extending upward from 700 feet above the surface within a 6.9-mile
radius of Greenwood-Leflore Airport and within 1.2 miles each side
of the Sidon VORTAC 079[deg] radial, extending from the 6.9-mile
radius to 2 miles each side of the VORTAC.

    Issued in College Park, Georgia, on May 8, 2018.
Debra L. Hogan,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2018-10389 Filed 5-16-18; 8:45 am]
 BILLING CODE 4910-13-P


EPA-HSRB-10-01

Paul Anastas, PhD

EPA Science Advisor

Office of the Science Advisor

1200 Pennsylvania Avenue, NW

Washington, DC 20460

Subject: June 23, 2010 EPA Human Studies Review Board Meeting Report

Dear Dr. Anastas,

	The United States Environmental Protection Agency (EPA or Agency)
requested that the Human Studies Review Board (HSRB) review two
completed repellent efficacy studies conducted by Carroll-Loye
Biological Research, Inc. (CLBR) of Davis, California. These two studies
involved intentional exposure of human volunteers to
picaridin-containing insect repellents. The Agency proposes to rely on
these two studies, conducted after publication of the EPA’s expanded
final rule for protection of subjects in human research (40 CFR 26) on
February 6, 2006 (71 Federal Register 24, 6137), for regulatory actions
under the pesticide laws.

	The Agency also provided the HSRB with additional information on two
informative topics: revised Agency guidelines for performance testing of
topically applied repellent products, to be released for use by
investigators and sponsors of new studies; and the recent settlement
agreement reached between the Agency and six external parties to resolve
litigation related to EPA’s 2006 rule for the protection of human
subjects of research.

	The enclosed report provides the Board’s response to EPA charge
questions presented at the June 23, 2010 meeting. In addition, the
report includes some additional recommendations for revising the Agency
repellent testing guidelines before release.

Assessment of Completed Carroll-Loye Biological Research Study LNX-002:
Efficacy Test of KBR 3023 (Picaridin, Icaridin) - Based Personal Insect
Repellents (20% Cream and 20% Spray) with Black Flies Under Field
Conditions.

Science

The Board concurred with the Agency’s assessment that this study
provides scientifically valid results to assess the repellent efficacy
against black flies for the formulations tested.

Ethics

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 26.

Assessment of Completed Carroll-Loye Biological Research Study LNX-003:
Efficacy Test of KBR 3023 (Picaridin; Icaridin) - Based Personal Insect
Repellents (20% Cream and 20% Spray) with Ticks Under Laboratory
Conditions.

Science

The Board concurred with the Agency’s assessment that this study
provides scientifically valid results to assess the repellent efficacy
against ticks for the formulations tested. However, the high frequency
of participants for whom the repellent’s protection time exceeded the
long duration of the study creates statistical challenges in evaluating
a specific protection time.

Ethics

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 26.

Revised Agency Guidelines for Performance Testing of Topically Applied
Insect Repellents

The Board was not given a charge for consideration of the revised
guidelines, but did have several comments designed to enhance the
utility of the document. The Board felt that the revised Agency
guidelines will provide sponsors and researchers with helpful guidance
in the design of future efficacy tests of topically applied insect
repellents. Before releasing these revised guidelines publicly, however,
the Board recommended several changes or clarifications, including:

Removal of the maximum-likelihood method requirement in the data
analysis section;

Clarification of recommendations regarding the use of positive controls,
particularly with respect to the number of controls and the rationale
for including them in the study;

Careful consideration of recommendations regarding the recruitment and
inclusion of so-called ‘vulnerable’ populations, including racial
and ethnic minorities; and

Encouraging the use of study designs that will enable investigators to
collect data that will allow quantitative measurement of the repellent
efficacy during the complete protection period.

Finally, as at previous meetings, the Board underscored that it would
continue to evaluate protocols submitted for review to the HSRB based on
appropriate statistical assumptions and analytic plans and thus might
recommend rejection of a protocol even if it followed the revised
Guidelines explicitly.

Sincerely,

Sean Philpott, PhD, MSBioethics

	Chair

	EPA Human Studies Review Board

NOTICE

This report has been written as part of the activities of the EPA Human
Studies Review Board, a Federal advisory committee providing advice,
information and recommendations on issues related to scientific and
ethical aspects of human subjects research.  This report has not been
reviewed for approval by the Agency and, hence, the contents of this
report do not necessarily represent the view and policies of the
Environmental Protection Agency, nor of other agencies in the Executive
Branch of the Federal government, nor does the mention of trade names or
commercial products constitute a recommendation for use.  You may obtain
further information about the EPA Human Studies Review Board from its
website at   HYPERLINK "http://www.epa.gov/osa/hsrb"
http://www.epa.gov/osa/hsrb .  You may also contact the HSRB Designated
Federal Officer, via e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
	In preparing this document, the Board carefully considered all
information provided and presented by the Agency presenters, as well as
information presented by public commenters.  This document addresses the
information provided and presented within the structure of the charge by
the Agency.

US ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD

Chair

Sean Philpott, PhD, MSBioethics, Director for Research Ethics, The
Bioethics Program of Union Graduate College and the Mount Sinai School
of Medicine, Schenectady, NY

Vice Chair

Janice Chambers, PhD, DABT, William L. Giles Distinguished Professor,
Director, Center for Environmental Health Sciences, College of
Veterinary Medicine, Mississippi State University, Mississippi State, MS

Members

George Fernandez, PhD, Professor of Applied Statistics, Director of the
University of Nevada-Reno Center for Research Design and Analysis,
University of Nevada-Reno, 1664 N. Virginia Street, Reno, NV

Vanessa Northington Gamble, MD, PhD, University Professor of Medical
Humanities, Professor of Health Policy and American Studies, The George
Washington University, Washington, DC

Sidney Green, Jr., PhD, Fellow of the ATS, Professor, Department of
Pharmacology, Howard University College of Medicine, Washington, DC

Dallas E. Johnson, PhD, Professor Emeritus, Department of Statistics,
Kansas State University, Manhattan, KS

Michael D. Lebowitz, PhD, FCCP, Retired Professor of Public Health &
Medicine, University of Arizona, Tucson, AZ

*Jose E. Manautou, PhD, Associate Professor of Toxicology, Department of
Pharmaceutical Science, University of Connecticut School of Pharmacy, 69
North Eagleville Road, Storrs, CT

Jerry A. Menikoff, MD, JD, Director, Office of Human Subjects Research,
Office of the Director, National Institutes of Health, Bethesda, MD

*Rebecca Parkin, PhD, MPH, Associate Dean for Research and Public Health
Practice, School of Public Health and Human Services, The George
Washington University, Washington, DC

William Popendorf, PhD, MPH, Professor, Department of Biology, Utah
State University, Logan, UT

Ernest D. Prentice, PhD, Associate Vice Chancellor for Academic Affairs,
University of Nebraska Medical Center, Omaha, NE

Virginia Ashby Sharpe, PhD, Medical Ethicist, National Center for Ethics
in Health Care, Veterans Health Administration 810 Vermont Ave., NW,
Washington, DC

Linda J. Young, PhD, Professor, Department of Statistics, Institute of
Food and Agricultural Sciences, University of Florida, Gainesville, FL

Human Studies Review Board Staff

Jim Downing, Executive Director, Human Studies Review Board Staff,
Office of the Science Advisor, United States Environmental Protection
Agency, Washington, DC

Not in attendance at June 23, 2010 Public Meeting

INTRODUCTION

On June 23, 2010, the United States Environmental Protection Agency’s
(EPA or Agency) Human Studies Review Board (HSRB) met to address
scientific and ethical issues concerning: two completed repellent
efficacy studies involving two registered insect repellents containing
picaridin conducted subsequent to publication of the EPA’s expanded
final rule for protection of subjects in human research. In accordance
with 40 CFR 26.1602, EPA sought HSRB review of these completed studies.
Each of these completed studies is discussed more fully below.

In addition, the Agency provided the HSRB with additional information on
two informative topics: the revised Agency guidelines for performance
testing of topically applied repellent products, to be released for use
by investigators and sponsors of new studies; and a recent settlement
agreement reached between the Agency and six external parties to resolve
litigation related to EPA’s 2006 rule for the protection of human
subjects of research. A summary of the Board’s conclusions concerning
the Agency’s revised guidelines for performance testing of topically
applied repellent products is also provided below.

REVIEW PROCESS

On June 23, 2010, the Board conducted a public face-to-face meeting in
Arlington, Virginia. Advance notice of the meeting was published in the
Federal Register as “Human Studies Review Board; Notice of Public
Meeting” (75 Federal Register 109, 32461).

Following welcoming remarks from Agency officials, the Board heard
presentations from EPA on the following topics: two completed insect
repellent efficacy studies involving intentional human exposure to two
registered insect repellents containing picardin (LNX-002 and LNX-003)
conducted by Carroll-Loye Biological Research, Inc. (CLBR) of Davis, CA.

The Board also asked clarifying questions of several study sponsors
and/or research investigators, including:

Dr. Scott Carroll, Principal, Carroll-Loye Biological Research

Mr. Shawn King, Director of Operations, Carroll-Loye Biological Research

Oral comments were provided by:

Dr. Scott Carroll, Principal, Carroll-Loye Biological Research

No written public comments were provided.

For their deliberations, the Board considered the materials presented at
the meeting, oral comments, and Agency background documents (e.g.,
published literature, sponsor and investigator research reports, study
protocols, data evaluation records, and Agency science and ethics
reviews of proposed protocols and completed studies). A comprehensive
list of background documents is available online at
http://www.regulations.gov.

CHARGE TO THE BOARD AND BOARD RESPONSE

Assessment of Completed Carroll-Loye Biological Research Study LNX-002:
Efficacy Test of KBR 3023 (Picaridin; Icaridin) - Based Personal Insect
Repellents (20% Cream and 20% Spray) with Black Flies Under Field
Conditions.

Overview of the Study

LNX-002 was a field-based study to measure the effectiveness of
picaridin as a black fly repellent when used in one of two compound
formulations (20% picardin KBR 3032 All-Family Insect Repellent Cream
and 20% picaridin KBR 3023 All-Family Insect Repellent Spray).

	A total of 25 participants (selected from a pool of 119 volunteers
diverse in age and ethnicity) participated in this study. There were 15
participants (8 female and 7 male) in the dosimetry phase. Twenty
treated and two untreated volunteers participated in the efficacy test,
with three more subjects serving as alternates. Ten participants tested
each product formulation.

Dosimetry data accumulated in a previous Carroll-Loye study (LNX-001),
along with additional dosimetry data collected from 15 volunteers in
LNX-002, were used for dose selection. For the spray product each
participant received 0.97μl/cm2 of product, equivalent to 0.9312 mg
product/μl. For the cream product, the volumetric dose rate was 1.94
μl/cm2, equivalent to 1.9012 mg product/μl. For the spray product the
mean picaridin dose was 98 mg per participant and 202 mg/participant for
the cream product. MOE calculations were based on an assumed 70 kg
participant and the acute dermal LD50 value for picaridin at the limit
dose of greater than 2,000 mg/kg. For the cream product the MOE = 690
and for the spray product the MOE = 1429, both values exceed the target
MOE = 100.

The efficacy of picaridin as a black fly repellent was determined in a
study conducted at a field site in the Mojave Desert of Southeastern
California. Ten participants each were randomly assigned to one of two
repellent treatments at the site for a total of ten volunteers per
treatment. Each treatment was applied to an equal number of males and
females. Participants were treated approximately 2.5 hours before field
exposure. Untreated controls and participants treated with repellent
were exposed to black flies for one minute every 15 minutes until the
repellent failed. Treated participants were partnered in groups of two
and each partner monitored the front of their own exposed forearm and
the back of their partner’s forearm. Black flies landing with intent
to bite (LIBe) were recorded, aspirated into containers, and identified
in the laboratory. Participants remained in the test until the repellent
failed as determined by the first confirmed LIBe, or until the end of
the test period, whichever came first. The time at which the repellent
failed equaled the Complete Protection Time (CPT) for each subject.

	Eleven of the 20 volunteers experienced a confirmed LIBe. Mean CPT
values were not significantly different for the two formulations, with
mean CPT calculated at 9.9 h for both products. Median CPT values also
were calculable for both products and were nearly the same, 10.1 h for
the cream product and 9.8 h for the spray product.

Science

Charge to the Board

	Is the CLBR study LNX-002 sufficiently sound, from a scientific
perspective, to be used to estimate the duration of complete protection
against black flies provided by the test repellents?

Board Response to the Charge

HSRB Recommendation

	The Board concurred with the Agency’s assessment (Sweeney 2010a) that
this study provides scientifically valid results to assess the repellent
efficacy against black flies for the formulations tested.

HSRB Detailed Recommendations and Rationale

	This study (Carroll 2010a; Carroll 2010c) was conducted according to a
protocol that had been amended to take into account recommendations of
the EPA and the HSRB (EPA HSRB 2009a).

	The conduct of the dosimetry study and the field study were very
similar to the conduct of previous field repellent efficacy studies
conducted by Carroll-Loye Biological Research.

	The study was carefully conducted, with both sexes represented among
the participants and the endpoint being the first confirmed landing with
intent to bite (LIBe) for each participant. The margins of exposure
(MOE) were high enough to not be a significant factor in the use of
either formulation.

	The protocol had one scientific deviation that was considered minor.
Namely, a black fly species not named in the protocol was present during
field testing. Board members felt that this deviation did not materially
affect the scientific integrity and validity of the study.

Ethics

Charge to the Board

	Does available information support a determination that study LNX-002
was conducted in substantial compliance with subparts K and L 40 CFR
Part 26?

Board Response to the Charge

HSRB Recommendation

The Board concurred with the Agency’s assessment (Carley 2010a) that
the study submitted for review was conducted in substantial compliance
with subparts K and L of 40 CFR 26.

HSRB Detailed Recommendation and Rationale

The documents provided by Carroll-Loye (Carroll 2010a; Carroll 2010c)
state that the study was conducted in compliance with the requirements
of the US EPA Good Laboratory Practice Regulations for Pesticide
Programs (40 CFR 160); 40 CFR 26 subparts K, L and M; FIFRA §
12(a)(2)(P); and the California Code of Regulations Title 3, Section
6710. The study was reviewed and approved by a commercial human subjects
review committee, Independent Institutional Review Board Inc. (IIRB,
Inc.) of Plantation, FL. Documentation provided to the EPA indicated
that IIRB, Inc. reviewed this study pursuant to the standards of the
Common Rule (45 CFR Part 46, Subpart A) and found it in compliance.
IIRB, Inc. also reviewed and approved Amendment 1 of October 30, 2009
(Carley 2010a; IIRB, Inc. 2010).

1.	The Board concurred with the conclusions and factual observations
relating to the study, as detailed in the EPA’s Ethics Review (Carley
2010a). Specifically:

a. 	Prior HSRB and Agency Review. The requirements of 40 CFR §26.1125
for prior submission of the protocol to EPA and of §26.1601 for HSRB
review of the protocol were satisfied. The study (Carroll 2010a; Carroll
2010c) was conducted in accordance with the protocol previously approved
by the HSRB (EPA HSRB 2009a). The Agency’s ethics review of  May 18,
2009 identified no deficiencies requiring correction relative to 40 CFR
26, subparts K and L, or to FIFRA § 12(a)(2)(P) (Carley 2010a). Because
the study was conducted in California, the approval of CDPR was also
required before the study could be initiated. CDPR granted final
approval of the amended protocol and supporting documents on September
14, 2009.

b.	Responsiveness to HSRB and Agency Reviews. Following the HSRB review,
the protocol and consent form were modified through Amendment 1 of
August 13, 2009 (Carley 2010a; Carroll 2010c). This amendment
incorporated changes responsive to the comments of EPA, the HSRB, and
California Department of Pesticide Regulation (CDPR), as well as
additional corrections initiated by the investigators and, at the
request of the sponsor, provision for collecting additional
dose-determination data for the cream formulation, to be pooled with
that originally collected in study LNX-001. Agency suggestions were also
addressed satisfactorily in Amendment 1. The reference to third party
coverage of costs of medical treatment noted by the HSRB was revised in
Amendment 1. IIRB, Inc. granted approval to Amendment 1 and supporting
documents on August 18, 2009 (Carley 2010a; Carroll 2010c).

c.	Substantial Compliance with Reporting Requirements (40 CFR §26
subpart M). The primary study report initially failed to address the
requirement of 40 CFR §26 subpart M, §26.1303(b) to submit copies of
“official notification to the sponsor or investigator ... that
research involving human subjects has been reviewed and approved by an
IRB.” This omission was corrected by the submission of a supplemental
document catalogued as MRID 48071301 (Carroll 2010c). Taking the two
submissions together, along with the separately submitted documents
reporting the roster and procedures of the IIRB, Inc., (2010), the
requirements of 40 CFR §26.1303 to document the ethical conduct of the
research were fully satisfied. Several Board members also remarked that,
while current regulations only require “substantial” compliance with
these reporting requirements, the submitted documents and supplementary
materials from IIRB, Inc. met fully the regulatory reporting
requirements.

2.	The Board concluded that this study met all applicable ethical
requirements for research involving human participants, in accordance
with the following criteria that had been stated in the Board’s prior
review of this study protocol:

a.	Acceptable risk-benefit ratio. The risks to study participants were
minimized appropriately and were justified by the potential societal
benefits, particularly data on the efficacy of these new formulations as
personal insect repellents.

Minors and pregnant or lactating women were excluded from participation,
with pregnancy confirmed by over-the-counter pregnancy testing on the
day of study or by opt-out. The potential of stigma resulting from study
exclusion was also appropriately minimized.

Based on toxicological data currently available for picaridin, coupled
with appropriate exclusion criteria, study participants were unlikely to
be at risk of adverse side effects with exposure.

Clear stopping rules and medical management procedures were in place,
and no adverse events related to product exposure were reported.

The study was designed to minimize the likelihood of black fly bites.

b.	Voluntary and informed consent of all participants

The study protocol included several mechanisms designed to minimize
coercive recruitment and enrollment. Monetary compensation was not so
high as to unduly influence participation.

3.	There were three minor protocol deviations reported, including: 1)
use of a superseded data collection form; 2) The presence of a second
species of biting black fly at the field test site; and 3) a gap of
greater than 60 days between dose determination and field testing. The
Board concluded, however, that these three deviations from the protocol
were minor and did not affect on the integrity of the research or the
safety of participants.

Assessment of Completed Carroll-Loye Biological Research Study LNX-003:
Efficacy Test of KBR 3023 (Picaridin; Icaridin) - Based Personal Insect
Repellents (20% Cream and 20% Spray) with Ticks Under Laboratory
Conditions.

Overview of the Study

LNX-003 was a laboratory-based study to measure the effectiveness of
picaridin as a tick repellent when used in one of two compound
formulations (20% picardin KBR 3032 All-Family Insect Repellent Cream
and 20% picaridin KBR 3023 All-Family Insect Repellent Spray). The
efficacy of picaridin as a tick repellent was determined in a controlled
laboratory setting by placing laboratory-raised, pathogen-free Western
black-legged ticks (Ixodes pacificus) and American dog ticks
(Dermacentor variabilis) on picaridin-treated and untreated forearms of
study volunteers, and then measuring the speed and distance that moving
ticks would penetrate into the treated area at 15-minute intervals. Each
treated participant served as their own untreated control. Tick questing
behavior was confirmed on the untreated arm of each subject before the
tick was used for repellency testing.

Dosimetry data accumulated in previous Carroll-Loye studies (LNX-001 and
LNX-002) were used for dose selection. For the spray product each
participant received 0.97μl/cm2 of product, equivalent to 0.9312 mg
product/μl. For the cream product, the volumetric dose rate was
1.94μl/cm2, equivalent to 1.9012 mg product/μl. For the spray product
the mean picaridin dose was 100 mg per participant and 192
mg/participant for the cream product. MOE calculations were based on an
assumed 70 kg subject and the acute dermal LD50 value for picaridin at
the limit dose of greater than 2,000 mg/kg. For the spray product the
mean picaridin dose was 100 mg per subject and 192 mg/subject for the
cream product. For the cream product the MOE = 741 and for the spray
product the MOE = 1429, both values exceed the target MOE = 100.

	A total of 23 participants (selected from a pool of 119 volunteers
diverse in age and ethnicity) participated in this study. Three were
alternate participants; twenty were treated. In the test phase, ten
subjects participated in each product treatment test on each day.
Treatments were randomized within each gender. There were an equal
number of male and female test subjects. Each volunteer participated on
only one day of the test, but testing included both tick species. All
ticks repelled or not, were removed from the arm of the participant
before they had time to bite. Exposure to each tick was for a period of
3 minutes on each arm. Further exposures to each species were stopped
for any subject who experienced a “crossing” by that species into
the treated area of the forearm confirmed by another crossing in either
of the subsequent two exposure periods. This endpoint was used to
calculate the Complete Protection Time (CPT) for each subject.

	Despite an extremely long duration of testing (15.25 h), more than half
the study participants did not experience a confirmed crossing. Thus, it
was not possible to calculate a median time to failure for the 20%
cream. Although there was also significant right-censorship of the data
for the 20% spray, there were enough data points to support calculation
of the Kaplan-Meier (K-M) median. The 20% cream had a mean CPT = 12.6 h
against Ix. scapularis and 15.3 h against D. variabilis. Most of these
data were right-censored and a median could not be calculated. For the
20% spray product, data collected with Ix. scapularis resulted in a
median CPT of 15 h while the mean CPT equaled 14.1 h. The mean CPT
against D. variabilis was 14 h and the median CPT was 14.1 h.

Science

Charge to the Board

	Is the CLBR study LNX-003 sufficiently sound, from a scientific
perspective, to be used to estimate the duration of complete protection
against ticks provided by the tested repellents?

Board Response to the Charge

HSRB Recommendation

The Board concurred with the Agency’s assessment (Sweeney 2010b) that
this study was conducted in accordance with Good Laboratory Practices as
described in 40 CFR §160, the draft EPA Guidelines §810.3700, and its
own previously approved protocols and that its results provide
scientifically sound data that can be used to estimate the duration of
complete protection against ticks.  However, the high frequency of
participants for whom the repellent’s protection time exceeded the
long duration (15.25 hours) of the study creates statistical challenges
in evaluating a specific protection time.

HSRB Detailed Recommendations and Rationale

	This study (Carroll 2010b) was conducted according to the protocol
previously approved by the HSRB (HSRB 2009b). The protocol fully
addressed the EPA’s comments in its review of the protocol and
responded to HSRB comments at the meeting in October 2009.  The study
incorporated the results of prior dosimetry studies and lessons learned
from previous laboratory tick repellent efficacy studies conducted by
Carroll-Loye Biological (Carroll 2010b).  The study seems to have been
carefully conducted with twenty participants (10 male and 10 female),
two formulations of one repellent at the same concentration (a cream and
spray, tested on separate days), and exposures to two genera of ticks
(nymphal deer ticks (Ixodes scapularis) and nymphal American dog ticks
(Dermacentor variabilis)) during each 15-minute interval for as long as
15.25 hours.  The MOE’s were very high (741 and 1429 for the cream and
spray, respectively) and therefore protective of the participating
volunteers. The report was clearly written and detailed.

There was interest expressed by some Board members regarding the
possible influence of subjective differences in the manipulations (the
“guiding” of the ticks shortly after they were placed on each
participant) upon the results; however, discussion revealed that the
time scale of these manipulations was sufficiently short in relation to
the three minutes they were allowed to remain on the arm to not be of
concern.

There was concern expressed by some Board members regarding the high
rates of right censorship (especially the 60% and 80% rate in the cream
formulation) caused by the lack of confirmed crossings by either tick
species within the study duration (despite it lasting just over 15
hours).  It was not possible to calculate a median CPT for the cream
formulation using Kaplan-Meier survival analysis. The Agency may wish to
consider the importance of these computations and the use of
Kaplan-Meier median complete protection time and its 95% lower
confidence interval when making decision regarding the efficacy of
insect repellents in future studies.

Ethics

Charge to the Board

	Does available information support a determination that study LNX-003
was conducted in substantial compliance with subparts K and L 40 CFR
Part 26?

Board Response to the Charge

HSRB Recommendation

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 26.

HSRB Detailed Recommendations and Rationale

The document provided by Carroll-Loye (Carroll 2010b) states that the
study was conducted in compliance with the requirements of the US EPA
Good Laboratory Practice Regulations for Pesticide Programs (40 CFR
160); 40 CFR 26 subparts K, L and M; FIFRA § 12(a)(2)(P); and the
California Code of Regulations Title 3, Section 6710. The study was
reviewed and approved by a commercial human subjects review committee,
Independent Institutional Review Board Inc. (IIRB, Inc.) of Plantation,
FL. Documentation provided to the EPA indicated that IIRB, Inc. reviewed
this study pursuant to the standards of the Common Rule (45 CFR Part 46,
Subpart A) and found it in compliance (c.f. Carley 2010b).

1.	The Board concurred with the conclusions and factual observations
relating to the study, as detailed in the EPA’s Ethics Review (Carley
2010b).

2.	The Board concluded that this study met all applicable ethical
requirements for research involving human participants, in accordance
with the following criteria that had been stated in the Board’s prior
review of this study:

a.	Acceptable risk-benefit ratio. The risks to study participants were
minimized appropriately and were justified by the potential societal
benefits, particularly data on the efficacy of these new formulations as
personal insect repellents.

Minors and pregnant or lactating women were excluded from participation,
with pregnancy confirmed by over-the-counter pregnancy testing on the
day of study or by opt-out. The potential of stigma resulting from study
exclusion was also appropriately minimized.

Based on toxicological data currently available for picaridin, coupled
with appropriate exclusion criteria, study participants were unlikely to
be at risk of adverse side effects with exposure.

Clear stopping rules and medical management procedures were in place,
and no adverse events related to product exposure were reported.

The study was designed to minimize the likelihood of tick bites.

Finally, the efficacy trial was conducted with laboratory-raised ticks
free of known pathogens.

b.	Voluntary and informed consent of all participants

The study protocol included several mechanisms designed to minimize
coercive recruitment and enrollment. Monetary compensation was not so
high as to unduly influence participation.

Revised Agency Guidelines for Performance Testing of Topically Applied
Insect Repellents (Product Performance Test Guidelines. OPPTS 810.3700:
Insect Repellents to be Applied to Human Skin).

In order to improve the quality and reliability of repellent data
submitted to the Agency, the EPA has developed a non-binding guidance
document (Product Performance Test Guidelines. OPPTS 810.3700: Insect
Repellents to be Applied to Human Skin) describing the methodology
recommended by the Agency for collection of the necessary data to
support registration and labeling of topically applied products (Office
of Chemical Safety and Pollution Prevention 2010). These revised
guidelines will replace the current “Product Performance Test
Guidelines. OPPTS 810.3700: Insect Repellents for Human Skin and Outdoor
Premises” released by the Agency in December 1999.

A draft version of these guidelines was first reviewed by the Board at
its June 2006 meeting, and again at its October 2008 meeting (EPA HSRB
2006; EPA HSRB 2008). In these reviews the Board made many suggestions
for strengthening the scientific and ethical conduct of this kind of
research, and has encouraged EPA to further revise and publish its
guidelines for researchers considering this type of study.

The EPA is expected to announce in the Federal Register the availability
of these new draft guidelines, for immediate use for sponsors and
investigators.

HSRB Evaluation

While the Board was not given a charge for consideration of the
guidelines, it did have several comments to enhance the utility of the
document. Specifically, the Board felt that the document was well
written and will provide sponsors and researchers with helpful guidance
in the design of future efficacy tests of topically applied insect
repellents. Before releasing these revised guidelines publicly, however,
the Board recommended the following changes or clarifications:

1. 	Currently (as described in the revised Guidelines’ Objectives
(c)(1)(i)), the preferred measure of repellent efficacy is the duration
of the Complete Protection Time (CPT).  CPT is important, but it is not
the only (and perhaps not always the best) measure of effectiveness. A
quantitative measure of the repellent’s effectiveness during the CPT
might also be useful.  For example, if opportunities to make
re-applications are limited but less protection is acceptable, then
consumers may wish to use a repellant with a long CPT.  If the repellant
can easily be re-applied however, consumers may want to choose a product
with higher effectiveness. The Agency thus may want to encourage the use
of study designs that yield a valid measure of repellent effectiveness
within the CPT.

2.	The revised Guidelines strongly encourage the use of “positive
[repellent] controls” (such as DEET) in the design of repellent
studies (c.f. Sec. (c)(viii) in the context of scientific study design
and in each of the specific guidance sections (j), (k), and (l)). The
Board felt that the justification for the use of positive controls
seemed weak. It was not clear from a scientific perspective just how
such data would be used to interpret a given study or what value it
would add, while increasing the number of additional human participants
exposed to the DEET control without a clear scientific benefit would
raise ethical concerns. The Board thus recommended that the Agency
clarify how and when positive controls should be included in the study
design, either in the revised Guidelines or in the accompanying Standard
Evaluation Procedures (SEPs).

3.	Maximum likelihood methods, as described in the Guidelines’
statistical analysis section, require that the distribution of data be
known. The Agency thus should remove from this section the
recommendation that maximum likelihood estimates be used if this
distribution is not known and the data cannot be transformed to fit an
underlying distribution. Use of maximum likelihood methods would, in
this case, be inappropriate.

4.	The revised Guidelines, as currently written, intermingle scientific
and ethical considerations. The Board recommended that the Agency
reexamine the organization and wording of the document in order to
distinguish between the two.

5.	The Board also recommended that, with respect to discussions of
participant recruitment and vulnerability, the following changes be
made:

  The term “race/ethnicity” should be used instead of just
“race.”

b.	When considering issues of participant vulnerability, the primary
concern is not just arbitrary exclusion of potentially vulnerable
populations if provisions can be made to ensure the safety of the
participants. There is also the concern of potential benefits from
research participation for vulnerable groups. The Guidelines should be
revised to address this fact.

c.	The Board also suggested that the EPA reexamine issues of language in
recruitment and consent materials in the Guidelines, referring the
Agency specifically to the Board’s October 2009 report (EPA HSRB
2009b), which explicitly discusses such issues of language.
Investigators should also be urged to examine the recruitment population
in advance so that speakers of other languages are present as needed.

REFERENCES

Carley, J.M. 2010a. Ethics Review of Completed Carroll-Loye Black Fly
Repellent Field Efficacy Study LNX-002. Dated May 20, 2010. Unpublished
document prepared by the Office of Chemical Safety and Pollution
Prevention, United States Environmental Protection Agency.

Carley, J.M. 2010b. Request for Additional Documentation. Email Exchange
between United States Environmental Protection Agency and Independent
Institutional Review Board, Inc. Dated April 20, 2010. Unpublished
document prepared by the Office of Chemical Safety and Pollution
Prevention, United States Environmental Protection Agency.

Carley, J.M. 2010c. Ethics Review of Completed Carroll-Loye Tick
Repellent Laboratory Efficacy Study LNX-003. Dated May 20, 2010.
Unpublished document prepared by the Office of Chemical Safety and
Pollution Prevention, United States Environmental Protection Agency.

Carroll, S. 2010a. Efficacy Test of KBR3023 (Picaridin; Icaridin)-Based
Personal

Insect Repellents (20% Cream and 20% Spray) with Black Flies under Field
Conditions. Dated April 5, 2010. Unpublished document prepared by
Carroll-Loye Biological Research. MRID 48053802.

Carroll, S. 2010b. Efficacy Test of KBR3023 (Picaridin; Icaridin)-Based
Personal

Insect Repellents (20% Cream and 20% Spray) with Ticks Under Laboratory
Conditions. Dated April 5, 2010. Unpublished document prepared by
Carroll-Loye Biological Research. MRID 48053801.

Carroll, S. 2010c. Supplemental Submission to EPA MRID 40853802. Dated
April 19, 2009. Unpublished document amendment prepared by Carroll-Loye
Biological Research. MRID 48071301.

EPA Human Studies Review Board. 2006. June 27-30, 2006 Human Studies
Review Board Meeting Report.

EPA Human Studies Review Board. 2008. October 21-22, 2008 Human Studies
Review Board Meeting Report.

EPA Human Studies Review Board. 2009a. June 24-25, 2009 Human Studies
Review Board Meeting Report.

EPA Human Studies Review Board. 2009b. October 20-21, 2009 Human Studies
Review Board Meeting Report.

Independent Institutional Review Board, Inc. (IIRB, Inc.). 2010. Roster
and Procedures. Unpublished materials prepared by IIRB.

W

X

ical Safety and Pollution Prevention, United States Environmental
Protection Agency.

Sweeney, K.J. 2010a. Science Review of Human Study of Black Fly
Repellent Performance. Dated May 24, 2010. Unpublished document prepared
by the Office of Chemical Safety and Pollution Prevention, United States
Environmental Protection Agency.

Sweeney, K.J. 2010b. Science Review of Human Study of Tick Repellent
Performance. Dated May 24, 2010. Unpublished document prepared by the
Office of Chemical Safety and Pollution Prevention, United States
Environmental Protection Agency.

Final Draft Dated July 28, 2010

Final Draft Dated September 2, 2010

Page   PAGE  16  of   NUMPAGES \*Arabic  17

Page   PAGE  1  of   NUMPAGES \*Arabic  17


[Federal Register Volume 79, Number 83 (Wednesday, April 30, 2014)]
[Notices]
[Page 24493]
[FR Doc No: 2014-09790]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2009-0023]

Petition for Amending Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that a document dated
March 8, 2014, the Hoosier Valley Railroad Museum (HVRM) petitioned the
Federal Railroad Administration (FRA) with a request to extend the
waiver of compliance granted by FRA on September 11, 2009, that
provided relief from certain provisions of 49 CFR 240.201(d),
Implementation. The petition was assigned to Docket Number FRA-2009-
0023.
    HVRM seeks to extend the period of current relief regarding
compliance with 49 CFR 240.201(d), which requires that ``[a]fter
December 31, 1991, no railroad shall permit or require any person to
operate a locomotive in any class of locomotive or train service unless
that person has been certified as a qualified locomotive engineer and
issued a certificate that complies with 240.223.'' HVRM desires to
continue its ``engineer-for-an-hour'' operation, which allows
noncertified individuals (generally, members of the public visiting the
museum) to operate a locomotive between Milepost (MP) 213.5 and MP 216.
HVRM believes that extending this waiver will enable it to continue to
generate funds to support its goal of acquiring and refurbishing
railroad antiquities so that they may be enjoyed by future generations.
    HVRM, which is controlled and operated by the Chesapeake and
Indiana Railroad, operates between MP 212.5 and MP 223.0 on track owned
by the Town of North Judson, IN. The museum's depot is located
approximately at MP 213.4. HVRM will continue to verify that each
participant is in possession of a valid State-issued motor vehicle
license, evaluate each participant visually for fitness to operate the
locomotive with respect to obvious signs of alcohol and/or drug use,
and will have a certified locomotive engineer in the cab at all times.
The operations will be conducted under Absolute Block Authority (a
section of track that can only be occupied by one train at a time) on
only a designated portion of track only during daylight hours. An HVRM-
qualified locomotive engineer will conduct a job briefing with each
participant to ensure all parties know and understand the movement to
be made and the individual responsibilities in the proposed movements.
HVRM would limit engineer-for-an-hour train size to one locomotive and
not more than three cars with no revenue passengers or members of the
public on board during operations. Any accident or incident that occurs
during an engineer-for-an-hour movement will be immediately reported to
FRA. HVRM also believes these operations will not pose any safety
concerns to the public at large.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received within June 16, 2014 of the date of this
notice will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
See http://www.regulations.gov/#!privacyNotice for the privacy notice
of regulations.gov or interested parties may review DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2014-09790 Filed 4-29-14; 8:45 am]
BILLING CODE 4910-06-P


Page 1 of 8 Summary of the Inorganic Chlorates Risk Assessment February 1, 2006 Introduction This document summarizes the Environmental Protection Agency's ( EPA or the Agency) human health risk assessment and conclusions for the herbicides, Inorganic Chlorates as presented fully in the documents, " Revised Inorganic Chlorates. HED Chapter of the Reregistration Eligibility Decision ( RED) Document" dated December 20, 2005, and " Sodium Chlorate Ecological Risk Assessment" dated January 31, 2005. The purpose of this summary is to assist the reader by identifying the key features and findings of these risk assessments, and to allow the reader to better understand the conclusions reached in the assessments. The human health and ecological risk assessments and supporting documents are available for public comment in EPA's pesticide docket and on the internet. There are some uncertainties associated with the assessment of risk to the inorganic chlorates. Thus the Agency is requesting additional information from the public so that the most informed regulatory decision can be made.

Of the inorganic chlorates listed as active ingredients ( i. e., sodium chlorate ( 073301), calcium chlorate ( 073302), potassium chlorate ( 073303), and magnesium chlorate ( 530200), only sodium chlorate ( 073301) is present as an active ingredient in currently registered products. Sodium chlorate ( 873301), calcium chlorate ( 875606), and potassium chlorate ( 900583) are present as inert ingredients in currently registered products and will be briefly addressed herein.

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to inorganic chlorates and any other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/. Page 2 of 8 Use Profile Chlorates are strong oxidizers used in the manufacture of dyes, explosives, matches, printing fabric, paper pulp processing, weed killers, and as a weak antiseptic, 2 3% solutions have been used in mouth washes. As a pesticide, sodium chlorate is considered phytotoxic and is used as a defoliant and a desiccant on agricultural crops to aid harvest, as well as for spot treatments to control weeds on roadsides and residential properties. It is a non selective, contact herbicide that can kill all green parts of plants by penetrating the cuticle causing cell death, probably by altering the metabolic processes. It is used primarily in the southern United States on cotton, but it is also used on a number of other agricultural commodities at application rates that range from approximately 4 to 12.5 lbs active ingredient/ acre. The primary use for sodium chlorate is as a precursor in chlorine dioxide generation through a closed system to bleach wood pulp/ paper. As a defoliant/ desiccant, professional agricultural uses include: cotton, corn, rice, dry beans, grain sorghum, flax, safflower, sunflower, soybeans, guar beans, southern peas, chili peppers ( for processing only), potatoes, ornamental gourds, cucurbits ( grown for seed), wheat, and fallow land. As a non selective herbicide it is used to kill grasses and weeds in industrial and non crop sites such as: rights of way areas, building perimeters, driveways, parking lots, fence rows, tennis courts, ditch banks, picnic areas, bleachers, cemeteries, fuel tank farms, airport runways, helo pads, wood decks, guard rails, highway medians, sidewalks/ walkways, vacant lots, fire hydrants, recreational areas, pipelines, railroads, lumberyards, and other similar areas. Only a small percentage ( less than 2 percent) is used in drinking water systems as a precursor to chlorine dioxide generation or as a defoliant/ desiccant. As inert ingredients, sodium chlorate ( 873301) and potassium chlorate ( 900583) are present in conventional ( agricultural) pesticides used on food crops or in poultry premises. Also, as inert ingredients, sodium chlorate ( 873301) and calcium chlorate ( 875606) are present in antimicrobial agents used: ( 1) as fruit, vegetable, and egg sanitizing washes; ( 2) to control bacterial blotch on mushrooms; ( 3) as treatment to seed used for sprouting; ( 4) for conditioning live oysters; ( 5) in poultry drinking water; ( 6) in fish filleting; and ( 7) pecan cracking/ dyeing.

Human Health Risk Assessment Dietary Risk ( Food)

A chronic ( non cancer and cancer) dietary risk assessment for food only was conducted using the Dietary Exposure Evaluation Model FCID   software with the Food Commodity Intake Database ( DEEM FCID   Version 2.03) and food consumption data from the United States Department of Agriculture's ( USDA's) Continuing Surveys of Food Intakes by Individuals ( CSFII) from 1994 1996 and 1998. The chronic ( non cancer and cancer) dietary risk assessment for food only is below the Agency's level of concern for the General U. S. Population and all Page 3 of 8 subgroups. The highest exposed population subgroup, children 1 2 years of age, was 28% of the chronic Population Adjusted Dose ( cPAD).

Dietary Risk ( Drinking Water)

Chronic ( non cancer and cancer) dietary ( water only) risk assessments were conducted using DEEM FCID   Version 2.03 and drinking water consumption data from the USDA's CSFII from 1994 1996 and 1998. Exposures were single point estimates.

Data on the occurrence of chlorate ion in drinking water were available from two primary sources: the Information Collection Rule ( ICR) Auxiliary 1 Database, Version 5.0 and the AwwaRF research study on the control of chlorate ion in hypochlorite solutions. The most extensive data is from the ICR where source water and drinking water were monitored for chlorate ion between July 1997 and December 1998. Water systems serving a population of at least 100,000 were required to monitor for chlorate ion at treatment plants using chlorine dioxide or hypochlorite solutions in the treatment process. Plants using chlorine dioxide collected monthly samples of the source water entering the plant, the finished water leaving the plant, and at three sample points in the distribution system ( near the first customer, an average residence time and a maximum residence time). Plants using hypochlorite solutions were only required to collect quarterly samples of the water entering and leaving the plant. If chlorine dioxide or hypochlorite solutions were used intermittently at a plant, chlorate ion samples were only required in sample periods in which they were in use. The ICR Database was considered the more appropriate source for estimating averages from individual water treatment plants primarily because the AwwaRF study is a less robust data set consisting of only one sample per utility; whereas the ICR database collected multiple samples over an 18 month period. Both the AwwaRF study and the ICR data reveal high concentrations of chlorate ion to be a local problem affecting a relatively small number of systems.

The chronic ( non cancer) dietary ( water only) risk assessment for chlorate in drinking water, using the highest annual average concentration estimated at 0.7 mg/ L, is below the Agency's level of concern for the General U. S. Population and all subgroups except all infants < 1 year of age. The highest exposed population subgroup, all infants < 1 year of age, was 161% of the chronic Population Adjusted Dose ( cPAD). Using the 90th percentile annual average concentration estimated at 0.24 mg/ L, the chronic ( non cancer) dietary ( water only) risk for all infants < 1 year of age was < 69% of the cPAD and 23% of the cPAD using the median annual average concentration estimated at 0.1 mg/ L.

No separate cancer dietary risk assessment for chlorate in drinking water was conducted. The estimated cancer dietary risk for the General U. S. Population is based on the chronic ( noncancer dietary risk, and is below the Agency's level of concern i. e., % cPAD is less than the level of concern of 100%.

Use of the ICR data could underestimate concentrations in drinking water since higher levels of chlorate ion ( ClO 3 G ) in drinking water were found at the smaller water treatment utilities sampled in the AwwaRF project than at the large water systems included in the ICR. However, Page 4 of 8 it should be noted that although the ICR water systems represent roughly one percent of the total number of drinking water systems in the United States, they serve almost 60 percent of the population. Additionally, only four water treatment plants had average chlorate ion concentrations which exceed the Agency's level of concern ( i. e., 370 ppb or 0.37 mg/ L for the infant subpopulation) including one treatment plant serving 218,000 people that had the highest annual average ( 0.7 mg/ l). The total number of people served by the four water treatment systems exceeding 0.37 mg/ L represents 0.5% of the ICR population or 621,000 people. All three exposure ranges ( highest average, 90th percentile, and median) are presented in the dietary analysis ( DEEM). Only the " highest average" exposures resulted in potential risks to infants. Further, it is estimated that less than one percent of the infants served by these systems could be exposed to concentrations up to 161% of the chronic PAD.

Water systems that use chlorine dioxide can control the levels of ClO 3 b in the finished water through high efficiency operation of their chlorine dioxide generators and by reducing ClO 2 b concentrations prior to the addition of free chlorine. Careful control of the generation process minimizes chlorate ion formation. Ferrous ion, which is a coagulant aid, can be used to convert ClO 2 b to chloride ion and thus prevent it from reacting with free chlorine to form ClO 3 b .

Water system that use hypochlorite solutions can minimize the levels of chlorate ion by purchasing high quality hypochlorite solutions and through careful storage during use. The pH of the solution should be in the 12 to 13 range to minimize decomposition. Hypochlorite solutions should be protected from high temperatures and sunlight. Storage time should be minimized; both from the time of manufacture to delivery and from the time of delivery to use. The solutions can also be diluted to control decomposition as long as the proper pH is maintained and high quality dilution water is used.

It should also be noted that levels of chlorate ion ( ClO 3 b ) found in finished drinking water are more likely a consequence of drinking water treatment with chlorine dioxide or hypochlorite than from possible source water contamination due to inorganic chlorate pesticide uses and/ or discharge from pulp mills which use inorganic chlorates in their bleaching process. Chlorate ion ( ClO 3 b ) is a disinfection by product ( DBP) of water treatment which can be formed during the on site generation of chlorine dioxide ( ClO 2 ), the decomposition of chlorine dioxide in the water treatment system, the decomposition of hypochlorite ( OCl b ) feedstock during storage, and the interaction of chlorite ion and free chlorine. Chlorate ion may also be present as a contaminant in the chlorite feedstock material used to generate chlorine dioxide and in some circumstances may be carried over to the finished drinking water. Technology to generate chlorine dioxide using sodium chlorate is now available to the drinking water industry, which introduces the possibility of ClO 3  carryover to the finished water from the chlorate feedstock.

Risks from Residential Use All residential ( non occupational) risk estimates for inorganic chlorates, as active or inert ingredients in conventional pesticide products used in residential environments, are below the Agency's level of concern ( i. e., Margin of Exposures are greater than the Level of Concern of 100). These uses are considered to be short term ( 1 30 days) only due to the episodic uses Page 5 of 8 associated with homeowner products. It should be noted that all residential uses of the sodium chlorate are being voluntarily canceled by the registrants.

Occupational Exposure and Risk With the addition of personal protection equipment ( PPE) ( dust/ mist respirator) or engineering controls ( enclosed cockpits or cabs), all occupational handler scenarios for the use of inorganic chlorates as an active or inert ingredient in conventional pesticides are below the Agency's level of concern ( i. e., Margin of Exposures are greater than the Level of Concern of 100). Exposure durations are short ( 1 30 days) and intermediate ( 1 6 months) term only. Since the exposure durations for occupational handlers are inconsistent with the mechanism of chlorate carcinogenicity, an occupational cancer risk assessment was not conducted.

Postapplication scenarios were not included in the occupational risk assessment for inorganic chlorates. Although dermal and inhalation exposures are possible, these exposures are expected to be negligible due to the physical and chemical characteristics of inorganic chlorates. Significant absorption of inorganic chlorates through intact skin is not expected. Postapplication inhalation exposure is not expected based on the negligible vapor pressure of sodium chlorate.

Tolerance Reassessment Summary The Agency has sufficient information for reassessing the tolerances for preharvest and foliar applications of sodium chlorate as a defoliant or desiccant. Under 40 CFR 180.1020 ( a) sodium chlorate is exempt from the requirement of a tolerance for residues in or on the following raw agricultural commodities when used as a defoliant, desiccant, or fungicide in accordance with good agricultural practice: beans ( dry, edible), corn ( fodder), corn ( forage), corn ( grain), cottonseed, flaxseed, flax ( straw), guar beans, peas ( southern), peppers ( chili), potatoes, rice, rice ( straw), safflower ( grain), sorghum ( grain), sorghum ( fodder), sorghum ( forage), soybeans and sunflower seed. A summary of the sodium chlorate tolerance reassessment and recommended modifications in commodity definitions is presented in Table 1. Page 6 of 8 Table 1. Tolerance Reassessment Summary for Sodium Chlorate Listed under 40 CFR 180.1020( a)

Commodity Current Tolerance ( ppm) Tolerance Reassessment ( ppm) [ Correct Definition] Comments beans, dry, edible Exempt Exempt [ Bean ( dry)]

corn, fodder Exempt Exempt [ Corn]

corn, forage Exempt corn, grain Exempt cottonseed Exempt Exempt [ Cotton]

flaxseed Exempt Exempt [ Flax]

flax, straw Exempt Revoke Flax straw is not listed in Table 1 of OPPTS 860.1000 guar beans Exempt Exempt [ Guar]

peas, southern Exempt Exempt [ Cowpea]

potatoes Exempt Exempt [ Potato]

peppers, chili Exempt Exempt [ Pepper ( nonbell)]

rice Exempt Exempt [ Rice]

rice, straw Exempt Exempt safflower, grain Exempt Exempt [ Safflower]

sorghum, grain Exempt Exempt [ Sorghum ( grain)]

sorghum, fodder Exempt sorghum, forage Exempt soybeans Exempt Exempt [ Soybeans]

sunflower seed Exempt Exempt [ Sunflower]

wheat None Exempt [ Wheat] Concomitant with the revocation of wheat under 40 CFR 180.1020 ( b) Page 7 of 8 Ecological Risk Assessment Available data suggest that there are no acute risk to fish, and birds, nor risks to aquatic plants, however, risks to fish, aquatic invertebrates, aquatic plants, birds, mammals and terrestrial plants cannot be precluded due to numerous uncertainties including ( 1) uncertainties in or lack of toxicity data; ( 2) uncertainties in the non agricultural herbicidal use pattern; and ( 3) uncertainties in environmental chemistry of chlorate, particularly in the amount of persistence of chemically related transformation products that may form under environmental conditions. The registrant has recently submitted several ecotoxicity studies which may significantly impact the ecological risk assessment.

Summary of Data Requirements & Label Amendments Toxicology 870.3465 28 Day Inhalation Study Residue Chemistry 860.1480 Magnitude of the Residue  Meat, Milk, Poultry, Eggs 860.1650 Submittal of Analytical Reference Standards Occupational and Residential Exposure Sodium chlorate ( 073301) end use product labels should be amended, as necessary, to include application rates in terms of lbs a. i./ acre treated for clarification.

Environmental Fate 164 1 Field dissipation study 71 4 Reproduction toxicity study in bobwhite quail and mallard ducks. 83 4 2 Generation reproduction toxicity study in laboratory rats 72 4 Chronic toxicity studies in fish and aquatic invertebrates 123 1 Tier II terrestrial plant seedling emergence and vegetative vigor studies 123 2 Tier II aquatic plant toxicity studies Acute toxicity studies in non guideline fish and aquatic plant species Not all of the current labels contain all of the language necessary to protect water resources; and should be revised for consistency. For example, many labels do not allow direct application to water ( surface water; intertidal areas), use through irrigation systems, contaminating water by cleaning of equipment or disposal of rinsates, discharge into sewage systems without notifying the pertinent sewage treatment plant authority ( PTOW), and carry NPDES license restriction. Page 8 of 8 Uncertainties There are some uncertainties associated with the assessment of risk to the inorganic chlorates. So that the Agency can make a more informed regulatory decision, the public and other interested parties are encouraged to submit any additional data to further refine the risk assessments, such as worker exposure data, percent crop treated information, residue data from food processing studies, use information for the non agricultural uses, drinking water treatment practices using chlorine dioxide and hypochlorite, etc., or could address the Agency's risk assessment methodologies and assumptions as applied to this specific pesticide.


[Federal Register: April 30, 2007 (Volume 72, Number 82)]
[Notices]
[Page 21263-21265]
[DOCID:fr30ap07-68]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0199; FRL-8124-7]

S-Abscisic Acid, (S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-1-
cyclohex-2-enyl)-3-methyl-penta-(2Z,4E)-dienoic Acid for Use in or on
Grapes; Notice of Filing to Establish a Temporary Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment or modification of regulations for
residues of pesticide chemicals in or on various commodities.

DATES: Comments must be received on or before May 30, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0199 and the pesticide petition number
(PP), by one of the following methods:
     Federal eRulemaking Portal:  http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0199. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless

the comment includes information claimed to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Do not submit information that you consider to be CBI or
otherwise protected through regulations.gov or e-mail. The
regulations.gov website is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through regulations.gov, your e-mail
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
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, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

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

I. General Information

A. Does this Action Apply to Me?

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

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. What Action is the Agency Taking?

    EPA is printing notice of the filing of a pesticide petition
received under section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, proposing the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. EPA has determined that the pesticide
petition described in this notice contains data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data supports granting of the pesticide
petition. Additional data may be needed before EPA rules on this
pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition included in
this notice, prepared by the petitioner, is included in a docket EPA
has created for this rulemaking. The docket for this petition is
available on-line at http://www.regulations.gov.

New Exemption from Tolerance

    PP 7G7202. Valent Biosciences Corporation, 870 Technology Way,
Libertyville, IL 60048, proposes to establish an exemption from the
requirement of a tolerance for residues of the biochemical pesticide,
S-Abscisic Acid; (S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-1-cyclohex-2-
enyl)-3-methyl-penta-(2Z,4E)-dienoic Acid, in or on food commodity
grapes. Because this petition is a request for an exemption from the
requirement of a tolerance without numerical limitations, no analytical
method is required.

List of Subjects

    Environmental protection, Agricultural commodities, Feed

additives, Food additives, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: April 18, 2007.

Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.

[FR Doc. E7-8179 Filed 4-27-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 88, Number 243 (Wednesday, December 20, 2023)]
[Notices]
[Pages 88065-88067]
[FR Doc No: 2023-27987]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP24-22-000]

Southern Star Central Gas Pipeline, Inc.; Notice of Application
and Establishing Intervention Deadline

    Take notice that on December 4, 2023, Southern Star Central Gas
Pipeline, Inc. (Southern Star), 4700 State Route 56, Owensboro,
Kentucky, 42301, filed an application under section 7(b) of the Natural
Gas Act (NGA), and Part 157 of the Commission's regulations, requesting
authorization to abandon by sale to Black Hills/Kansas Gas Utility
Company, LLC, d/b/a Black Hills Energy, 273 domestic meters in the
State

of Kansas. Southern Star states that there will be no change to its
certificated capacity as a result of this project, and that the project
will have no impact on any firm shippers, all as more fully set forth
in the application which is on file with the Commission and open for
public inspection.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (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. Public access
to records formerly available in the Commission's physical Public
Reference Room, which was located at the Commission's headquarters, 888
First Street NE, Washington, DC 20426, are now available via the
Commission's website. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TTY<PHONE_NUMBER>.
    Any questions regarding the proposed project should be directed to
Cindy C. Thompson, Director, Regulatory, Compliance and Information
Governance, Southern Star Central Gas Pipeline, Inc., 4700 State Route
56, Owensboro, Kentucky, 42301, by phone at<PHONE_NUMBER>, or by email
at [email protected].
    Pursuant to section 157.9 of the Commission's Rules of Practice and
Procedure,\1\ within 90 days of this Notice the Commission staff will
either: complete its environmental review and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or environmental
assessment (EA) for this proposal. The filing of an EA in the
Commission's public record for this proceeding or the issuance of a
Notice of Schedule for Environmental Review will serve to notify
federal and state agencies of the timing for the completion of all
necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
---------------------------------------------------------------------------

    \1\ 18 CFR (Code of Federal Regulations) Sec.  157.9.
---------------------------------------------------------------------------

Public Participation

    There are three ways to become involved in the Commission's review
of this project: you can file comments on the project, you can protest
the filing, and you can file a motion to intervene in the proceeding.
There is no fee or cost for filing comments or intervening. The
deadline for filing a motion to intervene is 5:00 p.m. Eastern Time on
January 4, 2024. How to file protests, motions to intervene, and
comments is explained below.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

Comments

    Any person wishing to comment on the project may do so. Comments
may include statements of support or objections, to the project as a
whole or specific aspects of the project. The more specific your
comments, the more useful they will be.

Protests

    Pursuant to sections 157.10(a)(4) \2\ and 385.211 \3\ of the
Commission's regulations under the NGA, any person \4\ may file a
protest to the application. Protests must comply with the requirements
specified in section 385.2001 \5\ of the Commission's regulations. A
protest may also serve as a motion to intervene so long as the
protestor states it also seeks to be an intervenor.
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    \2\ 18 CFR 157.10(a)(4).
    \3\ 18 CFR 385.211.
    \4\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
    \5\ 18 CFR 385.2001.
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    To ensure that your comments or protests are timely and properly
recorded, please submit your comments on or before January 4, 2024.
    There are three methods you can use to submit your comments or
protests to the Commission. In all instances, please reference the
Project docket number CP24-22-000 in your submission.
    (1) You may file your comments electronically by using the eComment
feature, which is located on the Commission's website at www.ferc.gov
under the link to Documents and Filings. Using eComment is an easy
method for interested persons to submit brief, text-only comments on a
project;
    (2) You may file your comments or protests electronically by using
the eFiling feature, which is located on the Commission's website
(www.ferc.gov) under the link to Documents and Filings. With eFiling,
you can provide comments in a variety of formats by attaching them as a
file with your submission. New eFiling users must first create an
account by clicking on ``eRegister.'' You will be asked to select the
type of filing you are making; first select ``General'' and then select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments or protests by
mailing them to the following address below. Your written comments must
reference the Project docket number (CP24-22-000).
    To file via USPS: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    To file via any other courier: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland
20852.
    The Commission encourages electronic filing of comments (options 1
and 2 above) and has eFiling staff available to assist you at (202)
502-8258 or [email protected].
    Persons who comment on the environmental review of this project
will be placed on the Commission's environmental mailing list, and will
receive notification when the environmental documents (EA or EIS) are
issued for this project and will be notified of meetings associated
with the Commission's environmental review process.
    The Commission considers all comments received about the project in
determining the appropriate action to be taken. However, the filing of
a comment alone will not serve to make the filer a party to the
proceeding. To become a party, you must intervene in the proceeding.
For instructions on how to intervene, see below.

Interventions

    Any person, which includes individuals, organizations, businesses,
municipalities, and other entities,\6\ has the option to file a motion
to intervene in this proceeding. Only intervenors have the right to
request rehearing of Commission orders issued in this proceeding and to
subsequently

challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
---------------------------------------------------------------------------

    \6\ 18 CFR 385.102(d).
---------------------------------------------------------------------------

    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \7\ and the regulations under the NGA \8\ by the
intervention deadline for the project, which is January 4, 2024. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
---------------------------------------------------------------------------

    \7\ 18 CFR 385.214.
    \8\ 18 CFR 157.10.
---------------------------------------------------------------------------

    There are two ways to submit your motion to intervene. In both
instances, please reference the Project docket number CP24-22-000 in
your submission.
    (1) You may file your motion to intervene by using the Commission's
eFiling feature, which is located on the Commission's website
(www.ferc.gov) under the link to Documents and Filings. New eFiling
users must first create an account by clicking on ``eRegister.'' You
will be asked to select the type of filing you are making; first select
``General'' and then select ``Intervention.'' The eFiling feature
includes a document-less intervention option; for more information,
visit https://www.ferc.gov/docs-filing/efiling/document-less-intervention.pdf.; or
    (2) You can file a paper copy of your motion to intervene, along
with three copies, by mailing the documents to the address below. Your
motion to intervene must reference the Project docket number CP24-22-
000.
    To file via USPS: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    To file via any other courier: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland
20852.
    The Commission encourages electronic filing of motions to intervene
(option 1 above) and has eFiling staff available to assist you at (202)
502-8258 or [email protected].
    Protests and motions to intervene must be served on the applicant
either by mail or email at: Cindy C. Thompson, Director, Regulatory,
Compliance and Information Governance, Southern Star Central Gas
Pipeline, Inc., 4700 State Route 56, Owensboro, Kentucky 42301, or at
[email protected]. Any subsequent submissions by an
intervenor must be served on the applicant and all other parties to the
proceeding. Contact information for parties can be downloaded from the
service list at the eService link on FERC Online. Service can be via
email with a link to the document.
    All timely, unopposed \9\ motions to intervene are automatically
granted by operation of Rule 214(c)(1).\10\ Motions to intervene that
are filed after the intervention deadline are untimely, and may be
denied. Any late-filed motion to intervene must show good cause for
being late and must explain why the time limitation should be waived
and provide justification by reference to factors set forth in Rule
214(d) of the Commission's Rules and Regulations.\11\ A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies (paper or
electronic) of all documents filed by the applicant and by all other
parties.
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    \9\ The applicant has 15 days from the submittal of a motion to
intervene to file a written objection to the intervention.
    \10\ 18 CFR 385.214(c)(1).
    \11\ 18 CFR 385.214(b)(3) and (d).
---------------------------------------------------------------------------

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.
    Intervention Deadline: 5:00 p.m. Eastern Time on January 4, 2024.

    Dated: December 14, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-27987 Filed 12-19-23; 8:45 am]
BILLING CODE 6717-01-P