[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Rules and Regulations]
[Pages 26993-26996]
[FR Doc No: 2022-09749]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2022-N-0175]

Medical Devices; General and Plastic Surgery Devices;
Classification of the Mountable Electromechanical Surgical System for
Transluminal Approaches

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the mountable electromechanical surgical system for
transluminal approaches into class II (special controls). The special
controls that apply to the device type are identified in this order and
will be part of the codified language for the mountable
electromechanical surgical system for transluminal approaches'

classification. We are taking this action because we have determined
that classifying the device into class II (special controls) will
provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices.

DATES: This order is effective May 6, 2022. The classification was
applicable on February 26, 2021.

FOR FURTHER INFORMATION CONTACT: Virag Patel, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4609, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the mountable electromechanical
surgical system for transluminal approaches as class II (special
controls), which we have determined will provide a reasonable assurance
of safety and effectiveness. In addition, we believe this action will
enhance patients' access to beneficial innovation, in part by placing
the device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On April 17, 2019, FDA received Memic Innovative Surgery Ltd.'s
request for De Novo classification of the Hominis Surgical System. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on February 26, 2021, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
878.4961.\1\ We have named the generic type of device mountable
electromechanical surgical system for transluminal approaches, and it
is identified as a software-controlled, patient bed- and/or operating
table-mounted electromechanical surgical system with human/device
interfaces that allows a qualified user to perform transluminal
endoscopic or laparoscopic surgical procedures using surgical
instruments attached to an electromechanical arm.
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    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

  Table 1--Mountable Electromechanical Surgical System for Transluminal
                Approaches Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Thermal, electrical, or mechanical       Non-clinical performance
 fault, or system malfunction resulting   testing; Electrical safety
 in tissue perforation or injury to       testing; Electromagnetic
 patient or user.                         compatibility (EMC) testing;
                                          Software verification,
                                          validation, and hazard
                                          analysis; Human factors
                                          assessment; Clinical
                                          performance testing; Annual
                                          reporting; and Labeling.
Use error resulting in patient injury:.  Non-clinical performance
 Dehiscence or delayed healing    testing; Human factors
 at the device access site..              assessment; Training; Clinical
 Hemorrhage....................   performance testing; Post-
 Thromboembolism...............   market surveillance; Annual
 Transluminal risks............   reporting; Control on
                                          distribution; and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation,
                                          and Pyrogenicity testing.
Infection..............................  Biocompatibility evaluation;
                                          Pyrogenicity testing;
                                          Sterilization validation;
                                          Reprocessing validation; Shelf-
                                          life testing; Clinical
                                          performance testing; and
                                          Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    While this final order contains no collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this final order. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 822, regarding postmarket surveillance of
medical devices, have been approved under OMB control number 0910-0449;
the collections of information in 21 CFR part 860, subpart D, regarding
De Novo classification have been approved under OMB control number
0910-0844; the collections of information in 21 CFR part 814, subparts
A through E, regarding premarket approval, have been approved under OMB
control number 0910-0231; the collections of information in part 807,
subpart E, regarding premarket notification submissions, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 820, regarding quality system regulation,
have been approved under OMB control number 0910-0073; and the
collections of information in 21 CFR part 801, regarding labeling, have
been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  878.4961 to subpart E to read as follows:

Sec.  878.4961   Mountable electromechanical surgical system for
transluminal approaches.

    (a) Identification. A mountable electromechanical surgical system
for transluminal approaches is a software-controlled, patient bed- and/
or operating table-mounted electromechanical surgical system with
human/device interfaces that allows a qualified user to perform
transluminal endoscopic or laparoscopic surgical procedures using
surgical instruments attached to an electromechanical arm.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The device manufacturer must develop, and update as necessary,
a device-specific use training program that ensures proper device
setup/use/shutdown, accurate control of instruments to perform the
intended surgical procedures, troubleshooting and handling during
unexpected events or emergencies, and safe practices to mitigate use
error.
    (2) The device manufacturer may only distribute the device to
facilities that implement and maintain the device-specific use training
program and ensure that users of the device have completed the device-
specific use training program.
    (3) The device manufacturer must conduct and complete post-market
surveillance, including an impact of the training program on user
learning, behavior, and performance, in accordance with an FDA-agreed-
upon protocol. The device manufacturer must submit post-market
surveillance reports that contain current data and findings in
accordance with the FDA-agreed-upon protocol.
    (4) The device manufacturer must submit a report to FDA annually on
the anniversary of initial marketing authorization for the device,
until such time as FDA may terminate such reporting, which comprises
the following information:
    (i) Cumulative summary, by year, of complaints and adverse events
since date of initial marketing authorization; and
    (ii) Identification and rationale for changes made to the device,
labeling or device-specific use training program, which did not require
submission of a premarket notification during the reporting period.
    (5) Labeling must include:
    (i) A detailed summary of clinical performance testing conducted
with the device, including study population, results, adverse events,
and comparisons to any comparator groups identified;

    (ii) A statement in the labeling that the safety and effectiveness
of the device has not been evaluated for outcomes related to the
treatment or prevention of cancer, including but not limited to risk
reduction, overall survival, disease-free survival and local
recurrence, unless FDA determines that it can be removed or modified
based on clinical performance data submitted to FDA;
    (iii) Identification of compatible devices;
    (iv) The list of surgical procedures for which the device has been
determined to be safe with clinical justification;
    (v) Reprocessing instructions for reusable components;
    (vi) A shelf life for any sterile components;
    (vii) A description of the device-specific use training program;
    (viii) A statement that the device is only for distribution to
facilities that implement and maintain the device-specific use training
program and ensure that users of the device have completed the device-
specific use training program; and
    (ix) A detailed summary of the post-market surveillance data
collected under paragraph (b)(3) of this section and any necessary
modifications to the labeling to accurately reflect outcomes based upon
the post-market surveillance data collected under paragraph (b)(3) of
this section.
    (6) Clinical performance testing must demonstrate that the device
performs as intended under anticipated conditions of use.
    (7) Human factors validation testing must be performed and must
demonstrate that the user interfaces of the system support safe use in
an operating room environment.
    (8) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use and
must include:
    (i) Device motion accuracy and precision;
    (ii) System testing;
    (iii) Instrument reliability;
    (iv) Thermal effects on tissue;
    (v) Human-device interface;
    (vi) Mounting hardware testing;
    (vii) Workspace access testing; and
    (viii) Performance testing with compatible devices.
    (9) Software verification, validation, and hazard analysis must be
performed. Software documentation must include an assessment of the
impact of threats and vulnerabilities on device functionality and end
users/patients as part of cybersecurity review.
    (10) Electromagnetic compatibility and electrical, thermal, and
mechanical safety testing must be performed.
    (11) Performance data must demonstrate the sterility of all
patient-contacting device components.
    (12) Performance data must support the shelf life of the device
components provided sterile by demonstrating continued sterility and
package integrity over the labeled shelf life.
    (13) Performance data must validate the reprocessing instructions
for the reusable components of the device.
    (14) Performance data must demonstrate that all patient-contacting
components of the device are biocompatible.
    (15) Performance data must demonstrate that all patient-contacting
components of the device are non-pyrogenic.

    Dated: April 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09749 Filed 5-5-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Rules and Regulations]
[Pages 18453-18456]
[FR Doc No: 2014-07240]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2012-0285; FRL-9909-01-Region-4]

Approval and Promulgation of Implementation Plans; Tennessee;
Conflict of Interest

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is finalizing two
actions pertaining to the Clean Air Act (CAA or Act) State
Implementation Plan (SIP) requirements for the State of Tennessee.
First, EPA is approving the SIP revision submitted by Tennessee,
through the Tennessee Department of Environment and Conservation (TDEC)
on October 9, 2013, as meeting the applicable requirements of the Act.
This SIP revision addresses Tennessee's outstanding obligations related
to the CAA State board and conflict of interest requirements. Second,
EPA is fully approving the infrastructure SIP sub-element related to
the State board and conflict of interest requirements for the 2008 Lead
National Ambient Air Quality Standards (NAAQS), 1997 Annual Fine
Particulate Matter (PM2.5) NAAQS, 2006 24-hour
PM2.5 NAAQS and 1997 8-hour ozone NAAQS. EPA notes that all
other applicable Tennessee infrastructure SIP elements for the 2008
Lead, 1997 annual PM2.5, 2006 24-hour PM2.5, and
1997 8-hour ozone NAAQS have been addressed in separate rulemakings.

DATES: This rule is effective on May 2, 2014.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2012-0285. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Regulatory Development Section, Air Planning Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. EPA

requests that if at all possible, you contact the person listed in the
FOR FURTHER INFORMATION CONTACT section to schedule your inspection.
The Regional Office's official hours of business are Monday through
Friday, 8:30 a.m. to 4:30 p.m. excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Sean Lakeman, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404)
562-9043. Mr. Lakeman can be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    By statute, SIPs meeting the requirements of sections 110(a)(1) and
(2) of the CAA are to be submitted by states within three years after
promulgation of a new or revised NAAQS. Sections 110(a)(1) and (2)
require states to address basic SIP requirements, including emissions
inventories, monitoring, and modeling to assure attainment and
maintenance of the NAAQS.
    More specifically, section 110(a)(1) provides the procedural and
timing requirements for SIPs. Section 110(a)(2) lists specific elements
that states must meet for ``infrastructure'' SIP requirements related
to a newly established or revised NAAQS. As mentioned above, these
requirements include SIP infrastructure elements such as modeling,
monitoring, and emissions inventories that are designed to assure
attainment and maintenance of the NAAQS. On July 23, 2012 (77 FR
42997), August 2, 2012 (77 FR 45958), and June 18, 2013 (78 FR 36440),
EPA approved in part, and conditionally approved in part, Tennessee's
infrastructure SIPs for the 1997 8-hour ozone NAAQS, 1997 annual
PM2.5 NAAQS, 2006 24-hour PM2.5 NAAQS and 2008
Lead NAAQS, respectively.
    Specifically, EPA conditionally approved the portion of section
110(a)(2)(E)(ii) (hereafter ``sub-element 110(a)(2)(E)(ii)'')
respecting the Act's section 128(a)(1) requirements for each of the
above NAAQS. Sub-element 110(a)(2)(E)(ii) provides that each
infrastructure SIP shall provide requirements ``that the State comply
with the requirements respecting State boards under section [128 of the
CAA]. . . .'' Section 128, in turn, provides that each SIP shall
contain requirements that: (1) Any board or body which approves permits
or enforcement orders under the CAA shall have at least a majority of
members who represent the public interest and do not derive a
significant portion of their income from persons subject to permits or
enforcement orders under the Act (hereafter ``section 128(a)(1)
requirements''); and, (2) any potential conflicts of interest by
members of such board or body or the head of an executive agency with
similar powers be adequately disclosed (hereafter ``section 128(a)(2)
requirements.'') EPA was unable to fully-approve Tennessee's
infrastructure submissions for the above NAAQS with respect to sub-
element 110(a)(2)(E)(ii) because, at the time, the SIP did not include
provisions to address the section 128(a)(1) requirements.\1\
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    \1\ The section 128(a)(2) conflict of interest disclosure
requirements, however, were met by existing provisions in the
Tennessee SIP. See 77 FR 42997, 42998; 77 FR 45958, 45960; and 78 FR
36440, 36442.
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    On March 28, 2012, TDEC transmitted a letter to EPA, committing to
adopt specific enforceable measures into its SIP by July 23, 2013, to
address section 128(a)(1). This commitment provided a basis for EPA to
exercise the conditional approval authority provided at section
110(k)(4) of the CAA. Consistent with this authority, Tennessee was
required to adopt the specified enforceable provisions and submit a
revision to EPA for approval by July 23, 2013 (one year following the
conditional approval action).\2\ As described at section 110(k)(4), and
as noted by EPA in its conditional approval actions, failure by the
State to adopt the specified provisions and submit them to EPA for
incorporation into the SIP by July 23, 2013, would result in the
conditional approvals automatically converting to disapprovals.
Tennessee failed to meet the July 23, 2013, commitment deadline, and
instead, submitted the section 128(a)(1) revisions to EPA on October 9,
2013. As a result, the sub-element 110(a)(2)(E)(ii) conditional
approvals automatically converted to disapprovals on July 23, 2013.
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    \2\ EPA's initial final action to conditionally approve sub-
element 110(a)(2)(E)(ii) occurred on July 23, 2012. Therefore,
Tennessee's commitment to submit the specific enforceable measures
necessary to comply with section 128(a)(1) requirements was due no
later than July 23, 2013. See 77 FR 42997.
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    On January 9, 2014, EPA provided notice of the conversion of the
section 110(a)(2)(E)(ii) conditional approvals to disapprovals. 79 FR
1608. In the same action, EPA also proposed to approve TDEC's October
9, 2013 SIP revision as being sufficient to address Tennessee's
outstanding obligations related to the CAA section 128(a)(1)
requirements. In addition, EPA also proposed through the January 9,
2014, action to approve infrastructure SIP sub-element 110(a)(2)(E)(ii)
related to the State board and conflict of interest requirements for
the 2008 Lead, 1997 annual PM2.5, 2006 24-hour
PM2.5, and 1997 8-hour ozone NAAQS.\3\ EPA received no
comments on these proposed actions.
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    \3\ The proposed approval of the infrastructure SIP sub-element
for these NAAQS was contingent upon EPA fully approving the TDEC
October 9, 2013, revision to address the requirements of CAA section
128(a)(1).
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II. Tennessee's State Board and Conflict of Interest Submission

    TDEC's October 9, 2013, SIP revision revises the content Chapter
1200-3-17 and moves it to a new chapter: Chapter 0400-30-17 Conflict of
Interest. Chapter 1200-3-17 is reserved for future use. The revision
further adds new sections 0400-30-17-.02 Protecting the Public
Interests and 0400-30-17-.05 Policy of Ethics and the Avoidance of
Conflicts of Interest. EPA is approving this revision because the
Agency has determined that, once approved into the Tennessee SIP, this
change will address the section 128(a)(1) requirements that any board
or body which approves permits or enforcement orders under the CAA have
at least a majority of members who represent the public interest and
not derive a significant portion of their income from persons subject
to permits or enforcement orders under the Act.
    Specifically, TDEC's revision incorporates a new rule into its SIP
to address section 128(a)(1) requirements. Rule 0400-30-17-.02
Protecting the Public Interests contains definitions and requirements
that will enable the Tennessee Air Pollution Control Board (hereafter
the ``Board'') to clearly determine if it has a majority of members who
represent the public interest and do not derive a significant portion
of their income from persons subject to permits or enforcement orders
under the Act. The intent of rule 0400-30-17-.02 is to ensure that at
least half of the Board serves in the public interest and does not
derive any significant income from persons subject to permits or
enforcement orders under the Act. Pursuant to these provisions, in the
event the Board is unable to determine that it is comprised consistent
with the requirements of section 128(a)(1), the revisions prevent the
Board from hearing contested cases until such time as it complies with
the requirements of section 128.
    TDEC is also revising sections 0400-30-17-.01 Purpose and Intent
(formally 1200-3-17-.01), 0400-30-17-.03 Conflict of Interest on the
Part of the

Board and Technical Secretary (formally 1200-3-17-.02) and 0400-30-
17-.04 Conflict of Interest in the Permitting of Municipal Solid Waste
Incineration Units (formally 1200-3-17-.03) of the SIP. EPA has
determined that these revisions, are sufficient to meet the State's
obligations pursuant to the requirements of CAA section 128(a)(1).

III. Tennessee's Infrastructure SIP Submission

    Sub-element 110(a)(2)(E)(ii) requires compliance with the
requirements respecting State boards and conflicts of interest pursuant
to section 128 of the Act. EPA reviews infrastructure SIP sub-element
110(a)(2)(E)(ii) submissions to ensure that the SIP includes provisions
satisfying section 128 requirements. Today's final approval of the
October 9, 2013, SIP revision to address section 128(a)(1) requirements
results in the Tennessee SIP fully meeting the applicable section 128
requirements.\4\ Accordingly, EPA is also hereby finalizing approval of
sub-element 110(a)(2)(E)(ii) with respect to the applicable section
128(a)(1) requirements for the 2008 Lead NAAQS, 1997 annual
PM2.5 NAAQS, 2006 24-hour PM2.5 NAAQS and 1997 8-
hour ozone NAAQS.
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    \4\ As previously noted, the section 128(a)(2) conflict of
interest disclosure requirements, were met by existing provisions in
the Tennessee SIP. See 77 FR 42997, 42998; 77 FR 45958, 45960; and
78 FR 36440, 36442.
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IV. Final Action

    EPA is approving the SIP revision submitted by TDEC on October 9,
2013, as meeting the applicable requirements of section 128(a)(1) the
Act. Additionally, EPA is fully approving the infrastructure SIP sub-
element 110(a)(2)(E)(ii) related to the State board and conflict of
interest requirements for the 2008 Lead NAAQS, 1997 Annual
PM2.5 NAAQS, 2006 24-hour PM2.5 NAAQS and 1997 8-
hour ozone NAAQS. These actions are being taken pursuant to section 110
of the CAA.
    EPA notes that the subject of this notice is limited to the section
128(a)(1) requirements and the associated infrastructure SIP sub-
element 110(a)(2)(E)(ii). All other applicable Tennessee infrastructure
SIP elements for the 2008 Lead NAAQS, 1997 annual PM2.5
NAAQS, 2006 24-hour PM2.5 NAAQS and 1997 8-hour ozone NAAQS
have been addressed in separate rulemakings.

V. Statutory and Executive Order Reviews

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

In addition, this action does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the State,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 2, 2014. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone,
Particulate Matter, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: March 21, 2014.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.

    For the reasons set out in the preamble, 40 CFR part 52, is to be
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart RR--Tennessee

Sec.  52.2219  [Removed and Reserved]

0
2. Section 52.2219 is removed and reserved.

0
3. Section 52.2220(c) is amended by:

0
a. Removing the entry in Table 1 for ``CHAPTER 1200-3-17 CONFLICT OF
INTEREST'' in its entirety; and
0
b. Adding in numerical order a new entry in Table 1 for ``CHAPTER 0400-
30-17 CONFLICT OF INTEREST''.
    The addition reads as follows:

Sec.  52.2220  Identification of plan.

* * * * *
    (c) * * *

                                   Table 1--EPA Approved Tennessee Regulations
----------------------------------------------------------------------------------------------------------------
                                                            State
         State citation              Title/subject     effective date   EPA approval date        Explanation
----------------------------------------------------------------------------------------------------------------
                                     CHAPTER 0400-03-17 CONFLICT OF INTEREST
----------------------------------------------------------------------------------------------------------------
Section 0400-30-17-.01..........  Purpose and Intent.       9/23/2013  4/2/2014 [Insert
                                                                        citation of
                                                                        publication].
Section 0400-30-17-.02..........  Protecting the            9/23/2013  4/2/2014 [Insert
                                   Public Interests.                    citation of
                                                                        publication].
Section 0400-30-17-.03..........  Conflict of               9/23/2013  4/2/2014 [Insert
                                   Interest on the                      citation of
                                   Part of the Board                    publication].
                                   and Technical
                                   Secretary.
Section 0400-30-17-.04..........  Conflict of               9/23/2013  4/2/2014 [Insert
                                   Interest in the                      citation of
                                   Permitting of                        publication].
                                   Municipal Solid
                                   Waste Incineration
                                   Units.
Section 0400-30-17-.05..........  Policy of Ethics          9/23/2013  4/2/2014 [Insert
                                   and the Avoidance                    citation of
                                   of Conflicts of                      publication].
                                   Interest.

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

* * * * *
[FR Doc. 2014-07240 Filed 4-1-14; 8:45 am]
BILLING CODE 6560-50-P


Table 3b. Annual Burden and Cost for the Federal Government to Implement ( Second Year)

NESHAP for Ferroalloy Production  Ferromanganese and Silicomanganese Production Facilities A B C D E F Burden Item EPA Number of Technical Management Clerical Total Cost Hours per Occurrences Hours per Year Hours per year Hours per year Per Year Occurrence Per Year ( C = A x B) ( C x 0.05) ( C x 0.1)

@ $ 32.99 @ $ 54.53 @ $ 16.74 Review initial notification reports 0 0 0 0 $ 0 Review notifications of compliance status 2 1 2 0.1 0.2 $ 75 Review semiannual summary reports 10 2 20 1 2 $ 748 Review notifications of performance tests 1 1 1 0.05 0.1 $ 37 Attend annual performance tests 25 1 25 1.25 2.5 $ 935 Review test results 5 1 5 0.25 0.5 $ 187 Total hours 53 2.65 5.3 Total Burden and Cost ( salary)

Travel TOTAL COST $ 1,982 Notes:

* Labor rates are based on the 1997 General Pay Schedule for federal employees, United States Office of Personnel Management..


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITION

EPA Registration Division contact: Sidney Jackson<PHONE_NUMBER>

Interregional Research Project Number 4

PP# 1E7842

     	EPA has received a pesticide petition (PP) 1E7842) from Interregional Research Project #4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing tolerances for residues of methoxyfenozide, including its metabolites and degradates, in or on the raw agricultural commodities Fruit, citrus, group 10-10 at 1.9 parts per million (ppm); Lemon, oil at 45 ppm; Citrus, oil (except lemon) at 100 ppm; Vegetable, root, except sugar beet, subgroup 1B at 0.8 ppm; Beet, sugar at 0.5 ppm.  The petition also proposes to remove the established tolerances for Vegetable, root, subgroup 1A and citrus oil at 100 ppm from table in paragraph (a) as well as Fruit, citrus, group 10 from the table in paragraph (c) upon the approval of the proposed tolerances listed above, and additionally, the petition proposes to revise the tolerance expressions in 40 CFR part 180.544 to read as follows:

(a)(1) Tolerances are established for residues of the insecticide methoxyfenozide, including its metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only methoxyfenozide [benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide].

(a)(2) Tolerances are established for residues of the insecticide methoxyfenozide, including its metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only the sum of methoxyfenozide  [benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide] and its glucuronide metabolite (β-D-Glucopyranuronic acid, 3-[[2-(1,1-dimethylethyl)-2-(3,5-dimethylbenzoyl)-
hydrazino]carbonyl]-2-methylphenyl-), calculated as the stoichiometric equivalent of methoxyfenozide.

b) Section 18 emergency exemptions. Time-limited tolerances specified in the following table are established for residues of the insecticide methoxyfenozide, including its metabolites and degradates, in or on the specified agricultural commodities, resulting from use of the pesticide pursuant to FFIFRA section 18 emergency exemptions.  Compliance with the tolerance levels specified below is to be determined by measuring only methoxyfenozide [benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide].  The tolerances expire and will be revoked on the date specified in the table.

d) Indirect or inadvertent residues. (1) Tolerances are established for the indirect or inadvertent residues of the insecticide methoxyfenozide, including its metabolites and degradates, in or on the raw agricultural commodities in the table below, when present therein as a result of the application of methoxyfenozide to growing crops as listed in paragraph (a) of this section.  Compliance with the tolerance levels specified below is to be determined by measuring only methoxyfenozide [benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide].

(2)  Tolerances are established for the indirect or inadvertent residues of the insecticide methoxyfenozide, including its metabolites and degradates, in or on the raw agricultural commodities in the table below, when present therein as a result of the application of methoxyfenozide to growing crops as listed in paragraph (a) of this section.  Compliance with the tolerance levels specified below is to be determined by measuring only the sum of methoxyfenozide [benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide] and the following metabolites (all calculated as the stoichiometric equivalent of methoxyfenozide): free phenol of methoxyfenozide [3,5-dimethylbenzoic acid N-tert-butyl- N′-(3-hydroxy-2-methylbenzoyl) hydrazide], the glucose conjugate of the phenol [3,5-dimethyl benzoic acid N-tert-butyl- N'-[3 (β-D-glucopyranosyloxy)-2-methylbenzoyl]-hydrazide] and the malonylglycosyl conjugate of the phenol [3,5-dimethyl benzoic acid N-tert-butyl- N'-[3 (β-D-6-malonyl-glucopyranosyl-1-oxy)-2-methylbenzoyl]-hydrazide].

      EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. Per the most recent EPA analytical summary for methoxyfenozide (D. Rate, US EPA, DP358341, June 10, 2009), the nature of the residue of methoxyfenozide in plants has been studied in several plants (apple, cotton, grape and rice) and is adequately understood.  For primary crops and drinking water, the tolerance expression is methoxyfenozide per se.

	2. Analytical method. Per the most recent EPA analytical summary for methoxyfenozide (D. Rate, US EPA, DP358341, June 10, 2009), adequate enforcement methods are available for determination of methoxyfenozide residues in plant commodities.  Analytical methodology for the magnitude of residue studies in citrus was based on a procedure based on Dow AgroSciences method GRM 02.25 "Determination of Residues of Methoxyfenozide in High Moisture Crops by Liquid Chromatography with Tandem Mass Spectrometry Detection".  The limit of detection (LOD) and the limit of quantitation (LOQ) values in citrus were calculated as 0.0072 ppm and 0.022 ppm, respectively.  Analytical methodology for the magnitude of residue studies in root crops used a procedure based on the Rohm and Haas Technical Report No. 34-98-87, "Tolerance enforcement method for Parent RH-2485 in Pome Fruit" with minor modifications.  The LOD and LOQ values were calculated as 0.0028 ppm and 0.0084 ppm, respectively.

	3. Magnitude of residues. For carrots, IR-4 recently completed trials in carrot (IR-4 PR No. 09884, May 28, 2010) to support reduction of the PHI on root crops in subgroup 1B from 14 days to 1 day.  Residues of methoxyfenozide were determined following 4 foliar applications of Intrepid 2F insecticide in 8 field locations in the EPA Regions 3, 5, 6, and 10 during the 2007 and 2008 growing season.  Methoxyfenozide was applied at a target rate of 0.25 lb ai/A, for a total of approximately 1.0 lb ai/A.  Applications were made 14 (2) days apart and samples collected 1 day after the final application.  A decline trial also included samples at 0, 1, 3, 6, 7, and 10 days after the last application.  The methoxyfenozide residues in carrot roots ranged from a maximum of 0.130 ppm to a minimum of 0.0266 ppm with a 0.1245 HAFT (Highest Average Field Trial) value at the PHI of 1 day and some decline was noted over the 10 days within the decline trial.

For radish, IR-4 recently completed trials (IR-4 PR No. 09895, June 14, 2010) to support reduction of the PHI on root crops in subgroup 1B from 14 days to 1 day.  Radish trials are limited to fewer applications based on the short growing season.  Residues of methoxyfenozide were determined following 2 foliar applications of Intrepid 2F insecticide across 4 Regions.  Methoxyfenozide was applied at a target rate of 0.25 lb ai/A, for a total of approximately 0.5 lb ai/A.  Applications were made 14 to 15 days apart and samples collected 1 day after the final application.  A decline trial also included samples at 0, 1, 3, 5, 7, and 9 days after the last application.  The methoxyfenozide residues in radish roots ranged from a maximum of 0.601 ppm to a minimum of 0.0442 ppm with a 0.453 ppm HAFT value at the PHI of 1 day and there was no significant decline over 9 days.

For citrus, IR-4 recently completed additional trials in orange, grapefruit and lemon (IR-4 PR No. A9367, August 25, 2010) to expand the currently approved regional use to a national registration for use of methoxyfenozide in citrus with a 1 day PHI.  Residues of methoxyfenozide were determined following four foliar applications of Intrepid 2F insecticide in 14 field locations in California, Florida and Texas during the 2008 growing season.  Methoxyfenozide was applied at a target rate of 0.25 lb ai/A, for a total of approximately 1.0 lb ai/A.  Applications were made 12 to 15 days apart and marketable citrus fruit was collected 1 day after the final application.  This new data is in addition to the 7 citrus trials (6 harvest trials and one processing trial) conducted from Regions 6 and 10 during 2005 and 2006 (IR-4 ID 09367, MRID 47556401, August 1, 2008; Federal Register of September 2, 2009 74 FRL-8433-8).

Based on the combined set of methoxyfenozide residues in citrus ranged from a maximum of 1.72 ppm to a minimum of 0.112 ppm with a 1.67 ppm HAFT value at the PHI of 1 day and there was no significant decline over the 14 days.  Residues ranges by sample type were: 0.191 to 0.1.72 ppm in oranges, from 0.112 to 0.312 ppm in grapefruit, and from 0.140 to 0.933 ppm in lemons).

The requested tolerances are adequately supported.

B. Toxicological Profile  The toxicological profile for methoxyfenozide which supports this petition to revise tolerances is assessed in the 2009 Human Health review (Rate, EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), and the endpoints for risk assessment are reiterated in EPA's most recent dietary assessment (EPA, Hanson, DP361376, July 7, 2009).  EPA has concluded "The toxicological database is adequate for the purpose of risk assessment and tolerance setting."

	1. Acute toxicity.  Per the 2009 Human Health review (Rate, EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009) , no significant acute hazards were attributable to a single exposure in the available toxicology studies on methoxyfenozide including the acute neurotoxicity study in rats, the developmental toxicity studying rats and the developmental toxicity study in rabbits.  Since no acute toxicological endpoints were established, no acute assessment is required.

	2. Genotoxicty. [Per the 2009 Human Health review (Rate, EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), methoxyfenozide demonstrated a "lack of genotoxicity in an acceptable battery of mutagenicity studies."

	3. Reproductive and developmental toxicity. Per the 2009 Human Health review (Rate, EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), methoxyfenozide "is not a developmental or reproductive toxicant".  The toxicology data base available for methoxyfenozide included acceptable developmental toxicity studies in both rats and rabbits as well as a 2-generation reproductive toxicity study in rats.  The data provided no indication of increased sensitivity of rats or rabbits to in utero and/or postnatal exposure to methoxyfenozide.  EPA determined that an additional safety factor was not needed for the protection of infants and children (FQPA SF = 1x).

	4. Subchronic toxicity. Per the 2009 Human Health review (Rate, EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), in subchronic and chronic oral studies in rats, the most toxicologically significant effects were mild anemia and mild effects on the liver, thyroid gland, and adrenal gland. In subchronic and chronic oral studies in dogs, the predominant toxic effect was anemia, which was often accompanied by signs of a compensatory response.

	5. Chronic toxicity. Per the 2009 Human Health review (Rate, EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), the chronic population-adjusted dose (cPAD) is 0.1 mg/kg/day based on hematological changes, liver toxicity, histopathological changes in thyroid and possible adrenal toxicity observed at the LOAEL of 411 mg/kg/day in a chronic toxicity study in rats.

	6. Animal metabolism. Per the 2009 Human Health review (Rate, EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), in a metabolism study in rats, [14]C-methoxyfenozide was rapidly absorbed, distributed, metabolized and almost completely excreted within 48 hours. The major route of excretion was feces (86-97%) with lesser amounts in the urine (5-13%).  Metabolism of methoxyfenozide in other animals (poultry and ruminants) appears to be similar to its metabolism in rats.  Per the most recent EPA analytical summary for methoxyfenozide (D. Rate, US EPA, DP358341, June 10, 2009), the qualitative nature of methoxyfenozide residues in livestock are adequately understood based on ruminant and poultry metabolism studies.  The residue of concern is parent in milk and ruminant tissues (except meat byproducts), poultry meat and fat.  The residues of concern in meat byproducts and eggs are methoxyfenozide and the RH-141,518 metabolite.

	7. Metabolite toxicology. Per the 2009 Human Health review (Rate, EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), in a metabolism study in rats, methoxyfenozide is metabolized principally by O-demethylation of the A-ring methoxy group and oxidative hydroxylation of the B-ring methyl groups followed by conjugation with glucuronic acid. No significant sex-related or dose-dependent differences in metabolic disposition were noted. The methoxyfenozide glucuronide conjugates are considered to be less toxic than the parent compound because glucuronide conjugation is well known to be a commonly occurring detoxification mechanism in mammalian species since it results in the formation of more polar, more water-soluble metabolites which are readily and easily excreted from the body (in this case, in the bile and urine). Further, based on similarities of chemical structure, the non-conjugated metabolites would be expected to be no more toxic than the parent compound. Furthermore, HED has covered potential metabolite exposure by inclusion of RH-141,518 along with the parent methoxyfenozide in the residue of concern for certain commodities: ruminant liver and kidney, eggs, poultry live and poultry meat byproducts.

	8. Endocrine disruption. The available mammalian toxicity and toxicokinetic studies on methoxyfenozide, including a 2-generation reproduction study, developmental toxicity studies in two species, and repeat dose toxicity studies ranging from 28 days to 2 year studies in three species (rat, mouse, and dog), do not demonstrate that methoxyfenozide possesses endocrine disrupting properties that are relevant to humans.

C. Aggregate Exposure

	1. Dietary exposure. The starting point for this assessment was the DEEM file from the 2009 EPA dietary assessment (EPA, Hanson, DP361376, July 7, 2009).  The Dietary Exposure Evaluation Model(TM) (DEEM-FCID, ver. 2.16, Exponent, Inc., Washington, DC-20036) software was employed.  DEEM contains food consumption data as reported by respondents in the USDA Continuing Surveys of Food Intake by Individuals (CSFII) conducted in 1994-1996 and 1998 and food translation to RACs, as indicated by EPA/USDA FCID recipe set as of August, 2002.

	i. Food. A chronic assessment was conducted to evaluate potential chronic dietary exposure of the U.S. population subgroups to residues of methoxyfenozide.  These analyses cover all registered crops, as well as revised proposed tolerances.  The current dietary assessment is an unrefined Tier I assessment using tolerance values and 100% crop-treated assumption to estimate dietary exposure to methoxyfenozide.  DEEM (ver 7.81) default processing factors for all food commodities, with the exception of a methoxyfenozide-specific processing factor for orange juice (0.2X).  The proposed citrus, and root crop uses do not alter the livestock burden calculations; assessment of livestock tolerances is not required.

	ii. Drinking Water. There are no water-related exposure data from monitoring to complete a quantitative drinking water exposure analysis and risk assessment for methoxyfenozide.  The previous EPA estimates of 33.1 ppb for potential drinking water exposures have been directly incorporated in the DEEM-FCID into the food categories "water, direct, all sources" and "water, indirect, all sources."

Per the 2009 Human Health review (Rate, EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), the established chronic endpoints are cRfD = cPAD = 0.10 mg/kg/day.  The Tier-I DEEM exposure for food and water with revised proposed tolerances resulted in an estimated exposure of 0.023895 mg/kg/day for the US general population which is 23.9% of the chronic RfD.  For the most highly exposed population subgroup, children 1 to 2 years old, the estimated exposure is 0.056857 mg/kg/day at 56.9% of cPAD.  These results are conservative (health protective) risk estimates.  Refinements such as use of percent crop-treated information and/or anticipated residue values would yield lower estimates of chronic dietary exposure.

	2. Non-dietary exposure. A new use in ornamentals was recently approved for methoxyfenozide in 2009.  Residential uses are limited to commercial applications on ornamentals for use in areas such as parks, recreation areas and residential property.  Because there is no homeowner use, the potential exposure is limited to a post-application scenario.  To account for this additional use in the aggregate assessment, an estimate of the potential exposure according to the residential SOPs was conducted.  Per the ornamental use label for Intrepid 2F Insecticide, the maximum label rate is 0.25 lb/A.  Per the 2009 Human Health review (Rate, EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), methoxyfenozide has not shown significant toxicity by dermal and/or inhalation routes; endpoints were deemed unnecessary for dermal or inhalation exposure.  Therefore, only the combined oral exposure for toddlers was estimated.  Without a dermal endpoint, there is no assessment necessary for adult post-application exposure from ornamental uses.  For toddlers, the combined potential oral exposure from hand to mouth, soil ingestion and object to mouth as 0.003747 mg/kg/day.  Potential exposure was conservatively assessed against the chronic dietary NOAEL of 10.2 mg/kg/day which was determined in the 2-year chronic rat study.  The resulting MOE value of 2669 for the combined oral routes in toddlers is well above the 100 value threshold of concern for the EPA.

For children, the potential post-application short term exposure from the ornamental use pattern were combined with chronic dietary (food and water) exposure for determination of aggregate short-term exposure.  The combined exposures were conservatively assessed against the chronic dietary endpoint with an assumed level of concern for incidental oral exposure of 100, for an aggregate risk assessment.  The table below is a summary of the short-term aggregate exposures and risk estimates.  Because the aggregate MOE values are 170 or greater, short-term aggregate exposure to methoxyfenozide is not of concern.  Based on EPA's conclusion that no dermal or inhalation endpoints were necessary, no aggregate risk assessment was conducted for adult.

 Short-Term Aggregate Risk Calculations for Children
                                   Population
                                     NOAEL
                                  (mg/kg/day)
                                     Target
                                      MOE
                        Chronic Food and Water Exposure
                                  (mg/kg/day)
                           Residential Oral Exposure
                                  (mg/kg/day)
                               Aggregate Exposure
                                  (mg/kg/day)
                                 Aggregate MOE
                         (food, water, and residential)
                              Children 1-2 yrs old
                                     10.2)
                                     Target
                                      MOE
                                    0.056857
                                    0.003747
                                    0.060604
                                      170
                              Children 3-5 yrs old

                                    0.044916
                                    0.003747
                                    0.048663
                                      210
                             Children 6-12 yrs old

                                    0.028025
                                    0.003747
                                    0.031772
                                      320

D. Cumulative Effects

Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency considers "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity."  EPA does not have, at this time, available data to determine whether methoxyfenozide has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment.  Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, methoxyfenozide does not appear to produce a toxic metabolite produced by other substances.  For the purposes of this tolerance action, therefore, it is assumed that methoxyfenozide does not have a common mechanism of toxicity with other substances.

E. Safety Determination

	1. U.S. population. Using the DEEM exposure assumptions described above, the dietary and water exposure to methoxyfenozide from the current and proposed new tolerances will utilize 23.9% of the chronic RfD for the US population.  EPA generally has no concern for exposures below 100% of the chronic RfD. It is concluded that there is a reasonable certainty that no harm will result to US-general population from exposure to methoxyfenozide residues.

	2. Infants and children. Per the 2009 Human Health review (Rate, EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 20090, EPA has previously determined that an additional safety factor was not needed for the protection of infants and children (FQPA SF = 1x).  Using the DEEM exposure assumptions described above for the dietary and water exposure to methoxyfenozide with the current and proposed new tolerances, the highest exposed subpopulation is children 1-2 years at 56.9% of the cPAD.  EPA generally has no concern for exposures below 100% of the cPAD because the cPAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health.  When the food, water and residential exposures are aggregated for children, the resulting MOEs are 170 or greater, which are well above the LOC of 100. Therefore, there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to methoxyfenozide exposure to methoxyfenozide residues.

F. International Tolerances

      Several governing bodies have established Maximum Residue Levels (MRLs) for methoxyfenozide in a variety of crops.  The germane international MRLs for root crops and citrus fruits are found in the following table based on a MRLs compiled by searches in Homologa (http://www.homologa.com/), the EU SANCO website (http://ec.europa.eu/sanco_pesticides/public/index.cfm) and the Australian MRL website (http://www.foodstandards.gov.au/foodstandards/foodstandardscode/standard142maximumre4244.cfm) .  Homologa is a third party database; IR-4 makes no claim regarding the verification of these values relative to the individual national authoritative sources.  The proposed change from 10 ppm to 1.9 ppm for citrus is congruent with other international tolerances.

Country
Crop
Amount
Unit
                                   Australia
CITRUS FRUITS
                                       1
                                      PPM
                                   Australia
CITRUS: PULP-DRY
                                      10
                                      PPM
                                     CODEX
Citrus
                                      0.7
                                      PPM
                                 EU Harmonized
Citrus fruit
                                       1
                                      PPM
                                 EU Harmonized
Root and tuber vegetables
                                     0.02
                                      PPM


[Federal Register Volume 88, Number 133 (Thursday, July 13, 2023)]
[Rules and Regulations]
[Pages 44674-44675]
[FR Doc No: 2023-14844]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-1008; Airspace Docket No. 23-AGL-14]
RIN 2120-AA66

Amendment of Class E Airspace; Wabash, IN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends the Class E airspace at Wabash, IN. This
action is the result of an airspace review caused by the
decommissioning of the Kokomo very high frequency omnidirectional range
(VOR) as part of the VOR Minimum Operating Network (MON) Program. The
geographic coordinates of the airport are also being updated to
coincide with the FAA's aeronautical database.

DATES: Effective 0901 UTC, October 5, 2023. The Director of the Federal
Register approves this incorporation by reference action under 1 CFR
part 51, subject to the annual revision of FAA Order JO 7400.11 and
publication of conforming amendments.

ADDRESSES: A copy of the Notice of Proposed Rulemaking (NPRM), all
comments received, this final rule, and all background material may be
viewed online at www.regulations.gov using the FAA Docket number.
Electronic retrieval help and guidelines are available on the website.
It is available 24 hours each day, 365 days each year.
    FAA Order JO 7400.11G, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; 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 the Class E airspace extending upward from 700 feet above
the surface at Wabash Municipal Airport, Wabash, IN, to support
instrument flight rule operations at this airport.

History

    The FAA published an NPRM for Docket No. FAA-2023-1008 in the
Federal Register (88 FR 29577; May 8, 2023) proposing to amend the
Class E airspace at Wabash, IN. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received.

Incorporation by Reference

    Class E airspace designations are published in paragraph 6005 of
FAA Order JO 7400.11, Airspace Designations and Reporting Points, which
is incorporated by reference in 14 CFR 71.1 on an annual basis. This
document amends the current version of that order, FAA Order JO
7400.11G, dated August 19, 2022, and effective September 15, 2022. FAA
Order JO 7400.11G is publicly available as listed in the ADDRESSES
section of this document. These amendments will be published in the
next update to FAA Order JO 7400.11.
    FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Rule

    This amendment to 14 CFR part 71 modifies the Class E airspace
extending upward from 700 feet above the surface to within a 6.5-mile
(decreased from a 7-mile) radius of Wabash Municipal Airport, Wabash,
IN; and updates geographic coordinates of the airport 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 5-6.5.a. 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 71

    Airspace, Incorporation by reference, Navigation (air).

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 14 CFR 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 FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

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

* * * * *

AGL IN E5 Wabash, IN [Amended]

Wabash Municipal Airport, IN
    (Lat. 40[deg]45'43'' N, long 85[deg]47'56'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Wabash Municipal Airport.
* * * * *

    Issued in Fort Worth, Texas, on July 10, 2023.
Steven T. Phillips,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2023-14844 Filed 7-12-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)]
[Notices]
[Page 51976]
[FR Doc No: 2018-22321]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3404-EM; Docket ID FEMA-2018-0001]

Hawaii; Amendment No. 1 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the State of Hawaii (FEMA-3404-EM), dated September 12, 2018, and
related determinations.

DATES: This amendment was issued September 26, 2018.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this emergency is closed effective September 13, 2018.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-22321 Filed 10-12-18; 8:45 am]
BILLING CODE 9111-11-P


[Federal Register Volume 85, Number 212 (Monday, November 2, 2020)]
[Notices]
[Page 69341]
[FR Doc No: 2020-24244]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2020-0001]

Notice of Adjustment of Countywide Per Capita Impact Indicator

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: FEMA gives notice that the countywide per capita impact
indicator under the Public Assistance program for disasters declared on
or after October 1, 2020, will be increased.

DATES: This adjustment applies to major disasters declared on or after
October 1, 2020.

FOR FURTHER INFORMATION CONTACT: Tod Wells, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street SW, Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In assessing damages for area designations
under 44 CFR 206.40(b), FEMA uses a countywide per capita indicator to
evaluate the impact of the disaster at the county level. FEMA will
adjust the countywide per capita impact indicator under the Public
Assistance program to reflect annual changes in the Consumer Price
Index for All Urban Consumers published by the Department of Labor.
    FEMA gives notice of an increase in the countywide per capita
impact indicator to $3.89 for all disasters declared on or after
October 1, 2020.
    FEMA bases the adjustment on an increase in the Consumer Price
Index for All Urban Consumers of 1.3 percent for the 12-month period
that ended in August 2020. The Bureau of Labor Statistics of the U.S.
Department of Labor released the information on September 11, 2020.

Catalog of Federal Domestic Assistance No. 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters).

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-24244 Filed 10-30-20; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: October 11, 2005 (Volume 70, Number 195)]
[Notices]
[Page 59106-59107]
[DOCID:fr11oc05-78]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52555, File No. SR-MSRB-2005-02]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Order Approving Proposed Rule Change Relating to Amendments to
MSRB Rule G-20, on Gifts and Gratuities, and MSRB Rule G-8, on
Recordkeeping

October 3, 2005.
    On January 13, 2005, the Municipal Securities Rulemaking Board
(``MSRB'' or ``Board''), filed with the Securities and Exchange
Commission (``SEC'' or ``Commission''), pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule change consisting of amendments to Rule
G-20, on gifts and gratuities, and the related recordkeeping
requirements of Rule G-8. The proposed rule change was published for
comment in the Federal Register on August 24, 2005.\3\ The Commission
received one comment letter regarding the proposal.\4\ On September 26,
2005, the MSRB filed a

response to the comment letter from Griffin, Kubik.\5\ This order
approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 52290 (August 18,
2005), 70 FR 49696 (August 24, 2005) (the ``Commission's Notice'').
    \4\ See letter to Jonathan G. Katz, Secretary, Commission, from
Robert J. Stracks, Counsel to Griffin, Kubik, Stephens & Thompson,
Inc. (``Griffin, Kubik''), dated September 13, 2005 (``Griffin,
Kubik's Letter'').
    \5\ See letter from Jill C. Finder, Assistant General Counsel,
MSRB, to Martha M. Haines, Chief, Office of Municipal Securities,
Commission, dated September 22, 2005 (``MSRB's Response Letter'').
---------------------------------------------------------------------------

    The proposed rule change would more fully conform Rule G-20 to NASD
requirements relating to gifts and gratuities, and add new provisions
governing non-cash compensation and sales incentives in connection with
municipal fund securities and other primary offerings of municipal
securities, based on NASD requirements for non-cash compensation and
sales incentives. A full description of the proposal is contained in
the Commission's Notice.
    Griffin, Kubik stated in its comment letter that they agree with
the MSRB that the regulation of gifts and gratuities ought to be
consistent across those regulators governing the conduct of broker-
dealers. Nonetheless, Griffin, Kubik's Letter states that they believe
that adoption of any changes to Rule G-20 is premature because they
understand that the NASD, the New York Stock Exchange, Inc. (``NYSE'')
and other regulators are currently considering the question of
appropriate rules and standards for gifts and because the status of the
NASD's current rule and interpretation is less than clear. The
Commission's Notice noted that the NYSE has a pending rule filing with
the Commission on gifts and gratuities that is currently being
reviewed, and that the MSRB has agreed to consider filing further
amendments to Rule G-20 or other rules, as necessary, to make its rules
on gifts and gratuities consistent with future rule changes made by
other self-regulatory organizations (SROs) overseen by the Commission.
    The MSRB's Response Letter stated that the MSRB determined that
provisions comparable to current NASD requirements governing gifts and
gratuities and the payment of non-cash compensation are appropriate for
dealers effecting transactions in municipal securities. The MSRB's
Response Letter also stated that, as the commentator noted, the MSRB
has undertaken to make its rules on gifts and gratuities consistent
with other self-regulatory organizations where appropriate for the
municipal securities market.
    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to the MSRB \6\ and, in particular, the
requirements of Section 15B(b)(2)(C) of the Act and the rules and
regulations thereunder.\7\ Section 15B(b)(2)(C) of the Act requires,
among other things, that the MSRB's rules be designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in municipal
securities, to remove impediments to and perfect the mechanism of a
free and open market in municipal securities, and, in general, to
protect investors and the public interest.\8\ In particular, the
Commission finds that the proposed rule change is consistent with the
Act because it will provide for more consistent treatment across the
securities markets regarding gifts, gratuities, non-cash compensation
and sales incentives, thereby facilitating dealer understanding of, and
compliance with, these requirements.
---------------------------------------------------------------------------

    \6\ In approving this rule the Commission notes that it has
considered the proposed rule's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).
    \7\ 15 U.S.C. 78o-4(b)(2)(C).
    \8\ Id.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act
\9\ that the proposed rule change (SR-MSRB-2005-02) be, and hereby is,
approved.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jonathan G. Katz,
Secretary.
[FR Doc. E5-5545 Filed 10-7-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: May 9, 2008 (Volume 73, Number 91)]
[Notices]
[Page 26467-26469]
[DOCID:fr09my08-130]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket ID PHMSA-2007-0056]

Pipeline Safety: Information Collection Activities Under Office
of Management and Budget Review

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
notice announces that the Information Collection Requests (ICR)
abstracted below will be forwarded to the Office of Management and
Budget (OMB) for review and comments. The ICRs describe the nature of
the information collections and their expected burden. PHMSA published
Notices in the Federal Register with 60-day comment periods soliciting
comments on these collections of information. PHMSA did not receive any
substantive comments

pertaining to the renewal of these information collections.

DATES: Submit comments on or before June 9, 2008.

ADDRESSES: Send comments regarding the burden estimate, including
suggestions for reducing the burden, to OMB, Attention: Desk Officer
for PHMSA, 725 17th Street, NW., Washington, DC 20503. Comments are
invited on: Whether the proposed collection of information is necessary
for the proper performance of the functions of the Department,
including whether the information will have practical utility; the
accuracy of the Department's estimate of the burden of the proposed
information collection; ways to enhance the quality, utility and
clarity of the information to be collected; and ways to minimize the
burden of the collection of information on respondents, including the
use of automated collection techniques or other forms of information
technology.

FOR FURTHER INFORMATION CONTACT: Barbara Betsock, U.S. Department of
Transportation, Pipeline and Hazardous Materials Safety Administration,
PHP-30, 1200 New Jersey Avenue, SE., East Building, 2nd Floor,
Washington, DC 20590-0001, Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Section 1320.8(d), Title 5, Code of Federal
Regulations requires PHMSA to provide interested members of the public
and affected agencies an opportunity to comment on information
collection and recordkeeping requests. This notice identifies
information collection requests that PHMSA will be submitting to OMB
for renewal and extension. These information collections are contained
in the pipeline safety regulations at 49 CFR parts 190-199. PHMSA has
revised burden estimates, where appropriate, to reflect current
reporting levels or adjustments based on changes in proposed or final
rules published since the information collections were last approved.
The following information is provided for each information collection:
(1) Title of the information collection, including former title if a
change is being made; (2) OMB control number; (3) abstract of the
information collection activity; (4) description of affected public;
(5) estimate of total annual reporting and recordkeeping burden; and
(6) frequency of collection. PHMSA will request a three-year term of
approval for each information collection activity and, when approved by
OMB, publish notice of the approval in the Federal Register.
    PHMSA published a Notice in the Federal Register with a 60-day
comment period soliciting comments on the following collection of
information (73 FR 5906; January 31, 2008) under Docket ID PHMSA-2007-
0056. PHMSA again requests comments on this information collection:
    Title: Pipeline Safety: Public Awareness Program.
    OMB Control Number: 2137-0622.
    Type of Request: Renewal of a currently approved information
collection.
    Abstract: Pipeline operators are required to implement a written
continuing public education program that follows the guidance provided
in the American Petroleum Institute's Recommended Practice 1162. (49
CFR 192.616 and 195.440). Upon request, an operator must submit its
completed program to PHMSA or, in the case of an intrastate pipeline,
the appropriate State agency. The operator must also make its program
documentation and evaluation results available for periodic review by
appropriate regulatory agencies.
    Estimated number of respondents: 22,500.
    Estimated annual burden hours: 517,480 hours.
    Frequency of collection: On occasion.
    PHMSA published a Notice in the Federal Register (73 FR 10509;
February 27, 2008) with a 60-day comment period soliciting comments on
the following collections of information under Docket ID PHMSA-2007-
0056. PHMSA again requests comments on these information collections:
    Title: Pipeline Safety: Recordkeeping and Accident Reporting for
Hazardous Liquid Pipeline.
    OMB Control Number: 2137-0047.
    Type of Request: Extension of a currently approved information
collection.
    Abstract: Operators of hazardous liquid pipelines are required
under 49 CFR part 195 to maintain records, make reports, and provide
information to PHMSA and State pipeline safety agencies concerning the
operations of their pipelines. The information aids Federal and State
pipeline safety inspectors in conducting compliance inspections and
investigating accidents.
    Estimated number of respondents: 200.
    Estimated annual burden hours: 51,011 hours.
    Frequency of collection: Annually and on occasion.

    Title: Pipeline Safety: Recordkeeping for Liquefied Natural Gas
Facilities.
    OMB Control Number: 2137-0048.
    Type of Request: Renewal of a currently approved information
collection.
    Abstract: Operators of liquefied natural gas facilities are
required under 49 CFR part 193 to maintain records, make reports, and
provide information to PHMSA and State pipeline safety agencies
concerning the operations of their pipelines. The information aids
Federal and State pipeline safety inspectors in conducting compliance
inspections and investigating incidents.
    Estimated number of respondents: 101.
    Estimated annual burden hours: 12,120 hours.
    Frequency of collection: On occasion.

    Title: Pipeline Safety: Recordkeeping for Gas Pipelines.
    OMB Control Number: 2137-0049.
    Type of Request: Renewal of a currently approved information
collection.
    Abstract: Operators of gas pipelines are required under 49 CFR part
192 to maintain records, make reports, and provide information to PHMSA
and State pipeline safety agencies concerning the operations of their
pipelines. The information aids Federal and State pipeline safety
inspectors in conducting compliance inspections and investigating
incidents.
    Estimated number of respondents: 22,300.
    Estimated annual burden hours: 940,454 hours.
    Frequency of collection: On occasion.

    Title: Pipeline Safety: Gas and Hazardous Liquid Pipeline Safety
Program Certifications.
    OMB Control Number: 2137-0584.
    Type of Request: Renewal of a currently approved information
collection.
    Abstract: A State agency participating in the pipeline safety
program must maintain records in order to demonstrate the agency is
properly monitoring the operations of pipeline operators in the State.
The agency submits a certificate to PHMSA annually verifying
compliance. PHMSA uses the information to evaluate the State's
eligibility for Federal grants.
    Estimated number of respondents: 67.
    Estimated annual burden hours: 3,820 hours.
    Frequency of collection: Annually.

    Title: Pipeline Safety: Integrity Management in High Consequence
Areas for Operators with Less than 500 Miles of Hazardous Liquid
Pipeline.
    OMB Control Number: 2137-0605.
    Type of Request: Renewal of a currently approved information
collection.
    Abstract: The pipeline integrity management regulations at 49 CFR
part 195 require operators of less than 500 miles of hazardous liquid
pipeline to have a program for integrity testing and

evaluation of their pipeline in high consequence areas. These are
environmentally sensitive and populated areas in which a pipeline
failure would have high consequences. Operators must maintain records
of the testing and evaluation. The information aids Federal and State
pipeline safety inspectors in conducting compliance inspections and
investigating accidents.
    Estimated number of respondents: 132.
    Estimated annual burden hours: 267,960 hours.
    Frequency of collection: Annually and on occasion.

    Issued in Washington, DC on May 1, 2008.
Barbara Betsock,
Acting Director of Regulations.
 [FR Doc. E8-10413 Filed 5-8-08; 8:45 am]

BILLING CODE 4910-60-P


[Federal Register Volume 76, Number 182 (Tuesday, September 20, 2011)]
[Notices]
[Pages 58255-58256]
[FR Doc No: 2011-24022]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP11-543-000, ANR Pipeline Company; Docket No. CP11-544-
000, TC Offshore LLC]

Notice of Application for Abandonment by Sale and Notice of
Application for Certificate of Public Convenience and Necessity

    Take notice that on September 1, 2011, ANR Pipeline Company (ANR),
an indirect wholly-owned subsidiary of

TransCanada Corporation, 717 Texas Street, Houston, Texas 77002-2761,
filed with the Federal Energy Regulatory Commission (Commission) an
application in Docket No. CP11-543-000 under Section 7(b) of the
Natural Gas Act (NGA) for permission and approval to abandon by sale to
TC Offshore LLC (TCO) certain onshore facilities located in Louisiana
and Texas, and certain offshore supply facilities located in State and
Federal waters offshore Louisiana and Texas in the Gulf of Mexico. Also
take notice that on September 1, 2011, TCO, a wholly-owned subsidiary
of ANR, 717 Texas Street, Suite 2400, Houston, Texas 77002-2761, filed
with the Commission an abbreviated application in Docket No. CP11-544-
000 under Section 7(c) of the NGA requesting authorization for TCO to
acquire, own and operate those natural gas pipeline facilities proposed
by ANR to be abandoned by sale, as well as blanket certificates issued
to TCO under Subpart F of Part 157 and Subpart G of Part 284 of the
Commission's regulations, all as more fully set forth in the
applications which are on file with the Commission and open to public
inspection.
    Specifically, ANR proposes in Docket No. CP11-543-000 to abandon by
sale to TCO various facilities consisting of approximately 535 miles of
pipeline, seven offshore platforms, measurement, compression,
separation and dehydration facilities, and appurtenances, as well as
its interests in several partially owned offshore facilities. TCO seeks
in Docket No. CP11-544-000 a certificate of public convenience and
necessity pursuant to NGA Section 7 authorizing TCO to acquire, own and
operate those natural gas pipeline facilities proposed for abandonment
by ANR in Docket No. CP11-543-000; a blanket construction certificate
pursuant to Subpart F of Part 157 of the Commission's regulations,
authorizing certain routine construction, operation and abandonment
activities; and a blanket transportation certificate under Subpart G of
Part 284 of the Commission's regulations authorizing TCO to provide
open access transportation service on behalf of others pursuant to the
services, tariff provisions and initial recourse rates proposed and
detailed in the application.
    Any questions regarding the ANR application in Docket No. CP11-543-
000 should be directed to Rene Staeb, Manager, Project Determinations &
Regulatory Administration, ANR Pipeline Company, 717 Texas Street,
Houston, Texas 77002-2761, phone<PHONE_NUMBER> or FAX<PHONE_NUMBER>
or<EMAIL_ADDRESS>    Any questions regarding the TCO application in Docket No. CP11-544-
000 may be directed to Richard Parke, Manager, Certificates, TC
Offshore LLC, 717 Texas Street, Suite 2400, Houston, Texas, 77002-2761,
phone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit an original and 7 copies of filings made with the Commission and
must mail a copy to the applicant and to every other party in the
proceeding. Only parties to the proceeding can ask for court review of
Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 7 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street, NE,,
Washington, DC 20426. This filing is accessible on-line at http://www.ferc.gov, using the ``eLibrary'' link and is available for review
in the Commission's Public Reference Room in Washington, DC. There is
an ``eSubscription'' link on the Web site that enables subscribers to
receive e-mail notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: October 4, 2011.

    Dated: September 13, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-24022 Filed 9-19-11; 8:45 am]
BILLING CODE 6717-01-P


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