[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Proposed Rules]
[Pages 73200-73202]
[FR Doc No: 2021-27917]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-1147; Airspace Docket No. 21-AGL-37]
RIN 2120-AA66

Proposed Establishment of Class E Airspace; Pembina, ND

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend the Class E airspace at Pembina,
ND. The FAA is proposing this action due to an airspace review
conducted as part of the decommissioning of the Humbolt very high
frequency (VHF) omnidirectional range (VOR) as part of the VOR Minimal
Operational Network (MON) Program. The geographic coordinates of the
airport would also be updated to coincide with the FAA's aeronautical
database.

DATES: Comments must be received on or before February 10, 2022.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2021-1147/Airspace Docket No. 21-AGL-37 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order JO 7400.11F, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. FAA Order JO 7400.11F is also available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of FAA Order JO 7400.11F at NARA, email:
[email protected] or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

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 would amend the Class E airspace extending upward from
700 feet above the surface at Pembina Municipal Airport, Pembina, ND,
to support instrument flight rule operations at this airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2021-1147/
Airspace Docket No. 21-AGL-37.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11F, Airspace
Designations and Reporting Points, dated August 10, 2021, and effective
September 15, 2021. FAA Order JO 7400.11F is publicly available as
listed in the ADDRESSES section of this document. FAA Order JO 7400.11F
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 by amending the
Class E airspace extending upward from 700 feet above the surface to
within a 6.4-mile (increased from a 6.2-mile) radius of Pembina
Municipal Airport, Pembina, ND; removing the Humbolt VORTAC and
associated extension from the airspace legal description; removing
Grand Forks AFB, Devils Lake VOR/DME, and the airspace extending upward
from 1,200 feet above the surface from the airspace legal description
as it is covered by the Class E airspace extending upward from 1,200
feet above the surface over the State of North Dakota, is redundant,
and no longer needed; adding exclusionary language north of latitude
49[deg]00'00'' N that prevents the airspace from extending into
Canadian airspace; and updating the geographic coordinates of the
airport to coincide with the FAA's aeronautical database.
    This action is due to an airspace review conducted as part of the
decommissioning of the Humbolt VOR, which provided navigation
information for the instrument procedures at this airport, as part of
the VOR MON Program.
    Class E airspace designations are published in paragraph 6005 of
FAA Order JO 7400.11F, dated August 10, 2021, and effective September
15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designations listed in this document will be published
subsequently in FAA Order JO 7400.11.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

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, is
non-controversial and unlikely to result in adverse or negative
comments. 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 will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 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.

71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

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

* * * * *

AGL ND E5 Pembina, ND [Amended]

Pembina Municipal Airport, ND

    (Lat. 48[deg]56'33'' N, long. 97[deg]14'26'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Pembina Municipal Airport, excluding
that airspace north of lat. 49[deg]00'00'' N.

    Issued in Fort Worth, Texas, on December 20, 2022.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2021-27917 Filed 12-23-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 202 (Monday, October 19, 2020)]
[Notices]
[Pages 66402-66403]
[FR Doc No: 2020-23088]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

NextGen Advisory Committee; Notice of Public Meeting

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation.

ACTION: Notice of public meeting.

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SUMMARY: This notice announces a meeting of the NextGen Advisory
Committee (NAC).

DATES: The meeting will be held virtually only on November 17, 2020,
from 1:00 p.m.-4:00 p.m. EST. Requests to attend the meeting virtually
and request for accommodations for a disability must be received by
November 2, 2020. If you wish to make a public statement during the
meeting, you must submit a written copy of your remarks by November 2,
2020. Requests to submit written materials to be reviewed by NAC
Members before the meeting must be received no later than November 2,
2020.

ADDRESSES: The meeting will be a virtual meeting only. Virtual meeting
information will be provided upon registration. Information on the NAC,
including copies of previous meeting minutes is available on the NAC
internet website at https://www.faa.gov/about/office_org/headquarters_offices/ang/nac/. Members of the public interested in
attending must send the required information listed in the
SUPPLEMENTARY INFORMATION to<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Greg Schwab, NAC Coordinator, U.S.
Department of Transportation, at<EMAIL_ADDRESS>or 202-267-
1201. Any requests or questions not regarding attendance registration
should be sent to the person listed in this section.

SUPPLEMENTARY INFORMATION:

I. Background

    NAC was created under the Federal Advisory Committee Act (FACA),
under the authority of the U.S. Department of Transportation, to
provide independent advice and recommendations to FAA, and to respond
to specific taskings received directly from FAA. The NAC recommends
consensus-driven advice for FAA consideration relating to Air Traffic
Management System modernization.

II. Agenda

    At the meeting, the agenda will cover the following topics:

 NAC Chairman's Report
 FAA Report
 NAC Subcommittee Chairman's Report
    [cir] Risk and Mitigations update for the following focus areas:
Multiple Runway Operations, Data Communications, Performance Based
Navigation, Surface and Data Sharing, and Northeast Corridor
 NAC Chairman Closing Comments

    The detailed agenda will be posted on the NAC internet website at
least one week in advance of the meeting.

III. Public Participation

    This virtual meeting will be open to the public on a first-come,
first served basis. Members of the public who wish to attend are asked
to register via email by submitting full legal name, country of
citizenship, contact information (telephone number and email address),
and name of your industry association, or applicable affiliation, to
the email listed in the ADDRESSES section. When registration is
confirmed, registrants will be provided the virtual meeting
information. Callers are responsible for paying associated long-
distance charges.

    Note: Only NAC Members, members of the public who have
registered to make a public statement, and briefers will have the
ability to speak. All other attendees will be listen only.

    The U.S. Department of Transportation is committed to providing
equal access to this meeting for all participants. If you need
alternative formats or services because of a disability, please contact
the person listed in the FOR FURTHER INFORMATION CONTACT section.
    Five minutes will be allotted for oral comments from members of the
public joining the meeting. To accommodate as many speakers as
possible, the time for each commenter may be limited. Individuals
wishing to reserve speaking time during the meeting must submit a
request at the time of registration, as well as the name, address, and
organizational affiliation of the proposed speaker. If the number of
registrants requesting to make statements is greater than can be
reasonably accommodated during the meeting, FAA may conduct a lottery
to determine the speakers. Speakers are required to submit a copy of
their prepared remarks for inclusion in the meeting records and for
circulation to NAC members to the person listed under the heading FOR
FURTHER INFORMATION CONTACT. All prepared remarks submitted on time
will be accepted and considered as part of the meeting's record.
    Members of the public may submit written statements for inclusion
in the meeting records and circulation to the NAC members. Written
statements need to be submitted to the person listed under the heading
FOR FURTHER INFORMATION CONTACT. Comments received after the due date
listed in the DATES section, will be distributed to the members but may
not be reviewed prior to the meeting. Any member of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, this 14th day of October 2020.
Tiffany McCoy,
General Engineer, NextGen Office of Collaboration and Messaging, ANG-M,
Office of the Assistant Administrator for NextGen, Federal Aviation
Administration.
[FR Doc. 2020-23088 Filed 10-16-20; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: June 17, 2010 (Volume 75, Number 116)]
[Rules and Regulations]
[Page 34365-34367]
[DOCID:fr17jn10-17]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0091]
RIN 1625-AA00

Safety Zone, Alligator River, NC

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
waters of the Alligator River at East Lake, North Carolina. The safety
zone is intended to temporarily restrict vessel traffic movement in the
zone area and is necessary to provide for the safety of mariners on
navigable waters during maintenance on the U.S. Highway 64 Swing
Bridge.

DATES: This rule is effective from 7 p.m. July 1, 2010 through 7 a.m.
September 30, 2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2010-0091 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0091 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail CWO4 Stephen Lyons, Waterways Management
Division Chief, Coast Guard Sector North Carolina; telephone (252) 247-
4525, e-mail<EMAIL_ADDRESS>If you have questions on
viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
because the publishing of an NPRM would be impracticable and contrary
to public interest since immediate action is needed to ensure the
public's safety during construction activity. Delaying the
implementation of the safety zone would subject the public to the
hazards associated with maintenance operations on the US Highway 64
Swing Bridge. The danger posed by marine traffic on the Alligator River
makes safety zone regulations necessary to provide for the safety of
construction support vessels and other vessels transiting the
construction area. For the safety concerns noted, it is in the public
interest to have these regulations in effect during construction. The
Coast Guard will issue broadcast notice to mariners to advise vessel
operators of

navigational restrictions. On-scene Coast Guard and local law
enforcement vessels will also provide actual notice to mariners.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date would
be contrary to public interest, since immediate action is needed to
ensure the safety of human life and property from the hazards
associated with the operation of heavy equipment in the waterway during
bridge maintenance operations.

Basis and Purpose

    The State of North Carolina Department of Transportation awarded a
contract to Coastal Gunite Construction Company of Cambridge, MD to
perform bridge maintenance on the U.S. Highway 64 Swing Bridge crossing
the Alligator River, North Carolina at Atlantic Intracoastal Waterway
Mile 84.2. The contract provides for cleaning, painting, and steel
repair to begin on July 1, 2010 and will be completed by September 30,
2010. The contractor will require the swing bridge to remain in the
closed position during painting. The Coast Guard will temporarily
restrict access to this section of Alligator River during the painting
of the swing when maintenance equipment will be obstructing the
waterway.

Discussion of Rule

    The temporary safety zone will encompass a 100 yard radius on the
waters of the Alligator River centered at (35[deg]54'3'' N/
076[deg]00'25'' W) a position directly under the U.S. Highway 64 Swing
Bridge. All vessels are prohibited from transiting this section of the
waterway while the safety zone is in effect. This zone will be in
effect from 7 p.m. to 7 a.m. daily from July 1, 2010 through September
30, 2010. A daily opening will be provided at 1 a.m. if a two hour
advanced notice is provided to the contractor by contacting the bridge
at telephone number<PHONE_NUMBER> or VHF Marine Band Radio channel 13.
Entry into the zone at any other time during the closure period will
not be permitted except as specifically authorized by the Captain of
the Port or a designated representative. To seek permission to transit
the area, mariners can contact Sector North Carolina at telephone
number<PHONE_NUMBER>.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    Although this regulation will restrict access to the area, the
effect of this rule will not be significant because: (i) The safety
zone will only be in effect from 7 p.m. to 7 a.m. daily, (ii) a daily
opening will be provided at 1 a.m. if a two hour advanced notice is
provided to the contractor by contacting the bridge at telephone number
(252) 796-7261 or VHF Marine Band Radio channel 13 (iii) the Coast
Guard will give advance notification via maritime advisories so
mariners can adjust their plans accordingly, and (iv) although the
safety zone will apply to the section of the Alligator River directly
under the U.S. Highway 64 Swing Bridge, vessel traffic can use
alternate waterways to transit safely around the safety zone.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of commercial tug and barge
companies, recreational and commercial fishing vessels intending to
transit the specified portion of Alligator River from 7 p.m. to 7 a.m.
from July 1, 2010 through September 30, 2010.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons. This
rule will only be enforced daily from 7 p.m. to 7 a.m. and a daily
opening will be provided at 1 a.m. if a two hour advanced notice is
provided to the contractor by contacting the bridge at telephone number
(252) 796-7261 or VHF Marine Band Radio channel 13. Although the safety
zone will apply to this section of the Alligator River, vessel traffic
can use alternate waterways to transit safely around the safety zone.
Before the effective period, the Coast Guard will issue maritime
advisories widely available to the users of the waterway.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

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

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have Tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian Tribes, on the relationship between the Federal Government and
Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves temporary safety zone to protect
the public from bridge maintenance operations. An environmental
analysis checklist and a categorical exclusion determination are
available in the docket where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

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

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6 and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1

0
2. Add Sec.  165.T05-0091 to read as follows:

Sec.  165.T05-0091  Safety Zone; Alligator River, NC.

    (a) Definitions. For the purposes of this section, Captain of the
Port means the Commander, Sector North Carolina. Representative means
any Coast Guard commissioned, warrant, or petty officer who has been
authorized to act on the behalf of the Captain of the Port.
    (b) Location. The following area is a safety zone: The temporary
safety zone will encompass a 100 yard radius on the waters of the
Alligator River centered at (35[deg]54'3'' N/076[deg]00'25'' W) a
position directly under the U.S. Highway 64 Swing Bridge.
    (c) Regulations. (1) The general regulations contained in Sec.
165.23 of this part apply to the area described in paragraph (b) of
this section.
    (2) Persons or vessels requiring entry into or passage through any
portion of the safety zone must first request authorization from the
Captain of the Port, or a designated representative, unless the Captain
of the Port previously announced via Marine Safety Radio Broadcast on
VHF Marine Band Radio channel 22 (157.1 MHz) that this regulation will
not be enforced in that portion of the safety zone. The Captain of the
Port can be contacted at<PHONE_NUMBER> or by VHF Marine Band Radio
channels 13 and 16.
    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the zone by Federal, State, and local agencies.
    (e) Enforcement period. This zone will be in effect from 7 p.m. to
7 a.m. daily from July 1, 2010 through September 30, 2010. A daily
opening will be provided at 1 a.m. if a two hour advanced notice is
provided to the contractor by contacting the bridge at telephone number
(252) 796-7261 or VHF Marine Band Radio channel 13.

    Dated: May 21, 2010.
A. Popiel,
Captain, U.S. Coast Guard, Captain of the Port North Carolina.
[FR Doc. 2010-14628 Filed 6-16-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: August 19, 2009 (Volume 74, Number 159)]
[Notices]
[Page 41955-41957]
[DOCID:fr19au09-102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60492; File No. SR-NASDAQ-2009-074]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Modify Fees for Members Using the NASDAQ Market Center

August 12, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934

(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 31, 2009, The NASDAQ Stock Market LLC (``NASDAQ'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III below, which Items
have been prepared by NASDAQ. Pursuant to Section 19(b)(3)(A)(ii) of
the Act \3\ and Rule 19b-4(f)(2) thereunder,\4\ NASDAQ has designated
this proposal as establishing or changing a due, fee, or other charge,
which renders the proposed rule change effective upon filing.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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    The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.

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

    NASDAQ proposes to modify pricing for NASDAQ members using the
NASDAQ Market Center. NASDAQ will implement this rule change on August
3, 2009. The text of the proposed rule change is available at http://
nasdaqomx.cchwallstreet.com/, at NASDAQ's principal office, and at the
Commission's Public Reference Room.

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

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

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

1. Purpose
    NASDAQ is proposing several changes to the fees associated with the
use of the NASDAQ Market Center. First, NASDAQ is modifying the fees
applicable to routing orders to NASDAQ OMX BX. Currently, NASDAQ passes
through all fees charged and rebates provided by NASDAQ OMX BX with
respect to orders routed to it. Pursuant to the change, NASDAQ will
provide this pass-through only with respect to orders that either (i)
check the NASDAQ book prior to routing and are then directed to route
first to NASDAQ OMX BX and then to NYSE or NYSE Amex; or (ii) route to
destinations other than NASDAQ prior to checking the NASDAQ book but
that are designated to return to NASDAQ after being routed. For
directed orders that route to NASDAQ OMX BX, NASDAQ will charge $0.0002
per share executed in the case of orders for securities listed on
NASDAQ or NYSE, and $0.0022 per share executed in the case of orders
for securities listed on other exchanges. For other orders routed to
NASDAQ OMX BX, NASDAQ will charge $0.0026 per share executed.
    Second, for securities listed on NASDAQ or NYSE, NASDAQ is reducing
the volume level required for a member to qualify for NASDAQ's most
favorable ``take rate'' for the months of August and September 2009.
Currently, a member pays a fee of $0.0027 per share executed if it has
an average daily volume in all securities during the month of (i) more
than 150 million shares of liquidity routed, removed, and/or provided,
and (ii) more than 35 million shares of liquidity provided. During
August and September 2009, the required volume of shares of liquidity
routed, removed, and/or provided will be reduced to 140 million shares,
with the required volume of liquidity provided remaining unchanged. The
change reflects expectations of overall lower trading volumes during
these months.
    Third, NASDAQ is eliminating special fees for orders that execute
at NYSE Arca as odd-lot transactions. The change reflects an
announcement by NYSE Arca that it will itself eliminate special fees
applicable to odd-lot transactions.\5\ Similarly, NASDAQ is modifying
special fees applicable to routed orders that execute at NYSE as odd-
lot transactions. Specifically, a special fee of $0.0005 per share
executed for orders that execute at NYSE as odd-lots after checking the
NASDAQ book will be eliminated; thus, such orders would pay the normal
routing fees applicable to orders that are not odd lots. Fees
applicable to orders that execute at NYSE as odd-lots without checking
the NASDAQ book remain unchanged.
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    \5\ See http://www.nyse.com/pdfs/Arca_Fee_Schedule_
Update.pdf.
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    Fourth, NASDAQ is modifying its fees for orders routed to NYSE that
execute in its opening or closing process to reflect announced changes
to NYSE's pricing for such orders.\6\ The fee for ``market at the
close'' and ``limit at the close'' orders will be $0.0007 per share
executed, and the fee for ``at the opening'' or ``at the opening only''
orders will be $0.0005, subject to a monthly cap of $10,000 per member.
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    \6\ See http://www.nyse.com/pdfs/NYSE_Pricing_Change_
20090801.pdf.
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    Fifth, NASDAQ is adding language to paragraph (a) of Rule 7018 to
clarify that for purposes of determining a member's shares of liquidity
routed, orders that do not attempt to execute in the NASDAQ Market
Center for the full size of the order prior to routing are not counted.
NASDAQ is also deleting obsolete language pertaining to calculating a
member's volume during the month of July 2009. Finally, NASDAQ is
making several changes to the text of Rule 7018 to make the punctuation
and phraseology of the rule consistent throughout.
2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\7\ in general, and with Section
6(b)(4) of the Act,\8\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees and other charges among
members and issuers and other persons using any facility or system
which NASDAQ operates or controls. NASDAQ is reducing the level of
liquidity required to receive a favorable take rate for orders in
stocks listed on NASDAQ or NYSE, resulting in potential price
reductions for members with large volumes of liquidity routed,
accessed, and/or provided. NASDAQ is also reducing the circumstances
under which it will pass through charges and rebates for orders routed
to NASDAQ OMX BX, and increasing fees for routing certain orders that
execute at NYSE as odd-lots. Finally, NASDAQ is making modifications in
its routing charges to reflect announced changes in the fees that it
will pay to route orders to NYSE and NYSE Arca.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f.
    \8\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The impact of the changes upon the net fees paid by a particular
market participant will depend upon a number of variables, including
its monthly volume, the order types it uses, and the prices of its
quotes and orders (i.e., its propensity to add or remove liquidity and
to set the best bid and offer). NASDAQ notes that it operates in a
highly competitive market in which market participants can readily
direct order flow to competing venues if they

deem fee levels at a particular venue to be excessive. NASDAQ believes
that its fees remain competitive with other venues and are reasonable
and equitably allocated to those members on the basis of whether they
opt to direct orders to NASDAQ.

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

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \9\ and subparagraph (f)(2) of Rule 19b-4
thereunder.\10\ At any time within 60 days of the filing of the
proposed rule change, the Commission may summarily abrogate such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(a)(ii).
    \10\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2009-074 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2009-074. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of NASDAQ. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2009-074 and should
be submitted on or before September 9, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-19894 Filed 8-18-09; 8:45 am]

BILLING CODE 8010-01-P


Page 1 of 23 Exposure Assessment Approaches For Chemicals Used As Soil Fumigants Consideration Of The Probabilistic Exposure And Risk Model For Fumigants ( PERFUM)  A Case Study With Iodomethane Presented To The FIFRA Science Advisory Panel By:

U. S. EPA Office Of Pesticide Programs Health Effects Division Presented On:

August 24/ 25, 2004 Page 2 of 23 1 INTRODUCTION On August 24 25, August 26 27, and September 9 10, 2004, the FIFRA Scientific Advisory Panel ( SAP) will hold three separate meetings to consider and review three fumigant bystander exposure models. At the August 24 25 meeting the SAP will review the Probabilistic Exposure and Risk model for FUMigants ( PERFUM) using iodomethane as a case study. On August 26 27, the SAP will review the Fumigant Exposure Modeling System ( FEMS) using metam sodium as a case study. On September 9 10, the SAP will review the SOil Fumigant Exposure Assessment system ( SOFEA( copyright)) using telone as a case study. In preparing for these meeting, preparation of this document, and development of questions for the Panel, the Agency has worked closely with scientists from the California Department of Pesticide Regulation who have significant experience with inhalation exposure modeling.

The purpose of this document is to provide general background information for the FIFRA Science Advisory Panel ( SAP) meeting pertaining to the evaluation of the Probabilistic Exposure And Risk Model For Fumigants ( or PERFUM). PERFUM represents a potential evolution of the Agency's current methodology for calculating exposures to bystanders who can be exposed by being in close proximity to fields treated with soil fumigants prior to planting crops such as strawberries or tomatoes. PERFUM was developed by the registrants ( i. e., manufacturers or licensees) of the soil fumigant iodomethane. At the upcoming SAP meeting, a detailed PERFUM case study will be presented based specifically on iodomethane data for illustrative purposes by its developers. More specific background materials pertaining to the theories and code included in PERFUM than there are in this document, are available in the following which has been provided by its developers for consideration ( available at: http:// www. epa. gov/ oscpmont/ sap/ 2004/# top).

A Probabilistic Exposure And Risk Model For Fumigant Bystander Exposures Using Iodomethane As A Case Study, Reiss and Griffin, July, 2004 The Agency has a broad range of goals for this meeting in that it wishes to evaluate the methodologies inherent in PERFUM from a general perspective to ( 1) determine their scientific validity and ( 2) determine if there is any general applicability for evaluating risks associated with many or all soil fumigants. There are three key criteria that the Agency considers when considering the integration of a model into its risk assessment process and these include: ( 1) public availability; ( 2) peer review for scientific validity; and ( 3) adherence to Agency guidelines for model development. In order to have PERFUM considered by the Agency and by the SAP the developers of PERFUM have agreed to make it available for public use.

The Agency is currently involved in the development of a comparative risk assessment for 6 pesticides that are used for soil fumigation purposes. Some of these chemicals also have other allowed uses but, for clarity, the discussion within this document focuses only on soil fumigation since it is of key concern and it accounts for the majority of the annual usage for each chemical. The chemicals which are included in this assessment are: chloropicrin, dazomet, iodomethane ( i. e., methyl iodide), methyl bromide, metam sodium ( or other salts), and telone ( or 1,3 dichloropropene). Each of these chemicals ( or their breakdown products, metam sodium and dazomet both emit MITC or methyl isothiocyanate which is the volatile component) are extremely Page 3 of 23 volatile especially when compared to most common pesticides. Most common pesticides are considered semi volatile organic chemicals ( or SVOCs) while soil fumigants would be considered volatile organic chemicals ( or VOCs). The volatility of each material is the key characteristic associated with their use and achieving a satisfactory measure of efficacy. This volatility, however, can lead to a potential for human exposures because it leads to transport away from targeted application areas to non target receptors such as nearby human populations.

The Agency's goal for this risk assessment is to quantify emissions from treated fields and use them as a determinant of human risks. Emissions from treated fields can be categorized in two ways including:

( 1) Known Source: include those directly associated with a single application ( or series of associated applications) adjacent to a receptor where the source and emissions specific to the application( s) can be quantified. An example would be treating a field that borders a residential subdivision then defining the amount of off target residue movement associated with that specific application. The concept of a buffer zone as a risk management tool is commonly associated with these situations.

( 2) Multiple Source ( Ambient Air): includes those associated with multiple applications or general use within a region where many non quantifiable applications can possibly contribute to overall exposure levels. In general, ambient exposures within a region cannot be easily attributed to specific application events. An example of this type of emission might be those air concentrations measured at a school location when the school is located within a growing region where fumigants are extensively used. The concept of a localized use cap as a risk management tool is commonly associated with these types of exposures.

A discussion and quantification of each type of emission will ultimately be included in the Agency risk assessment for soil fumigants, however, the focus of this document and the upcoming SAP meeting is the Probabilistic Exposure And Risk Model For Fumigants ( or PERFUM) which is intended to quantify emissions from single, known applications ( e. g., treating a field with a subdivision immediately adjacent to its perimeter).

In order to quantify emissions from single application events, the Agency currently uses an approach that first considered the monitoring data available for each of the six soil fumigants along with a deterministic modeling approach. It was clear that given the breadth of the uses associated with soil fumigants ( e. g., varied atmospheric conditions, application methods, and emission reduction technologies such as tarping or watering in) that use of monitoring data alone for risk assessment purposes was limited by the relatively small number of samples which can reasonably be generated for different times after treatment, distances from the application site, and use patterns. This conclusion led to the development of the Agency's current modeling approach and the possible evolution of that approach represented by PERFUM. The model based approach considers temporal and spatial factors, extrapolating from available monitoring data, thus providing an estimate of the range of exposures which are possible at different times and locations when input parameters are varied. Use of a model and monitoring data are, however, intertwined in a general sense because monitoring data are used as the basis for estimating emission factors used in the model. Page 4 of 23 The Agency is currently using a deterministic modeling approach for defining air concentration gradients downwind of applications for each chemical. In this approach, the Agency has based its analysis on a standardized set of meteorological conditions intended to represent a stable atmosphere and unidirectional wind patterns that is intended to provide highend estimates of exposure. To this end, the Agency has developed a methodology based on the Office of Air model ISC3 ( Industrial Source Complex Model) that is routinely used for regulatory purposes. ISC3 is a steady state Gaussian plume model which can be used to assess pollutant concentrations from a wide variety of sources. ISC3 is a publically available system and can be downloaded from the Agency ( http:// www. epa. gov/ scram001/ tt22. htm# isc).

Stakeholders have commented to the Agency a belief that these standardized meteorological conditions are not representative of actual atmospheric conditions where soil fumigants are used and therefore solely provide screening level results which are inadequate for risk mitigation decision making purposes. To this end, the iodomethane registrant has submitted to the Agency the PERFUM model for consideration. PERFUM integrates actual meteorological data into ISC3 which then provides for the calculation of multi directional air concentration gradients based on these data. As with the Agency's approach, these resulting concentration gradients would ultimately be used as a determinant of human health risks. Additionally, it should also be noted that the PERFUM model uses a probability based approach for integrating emission data which are unique to this system.

This document describes the Agency's current approach for model use in Section 2: Summary Of Current Modeling Approach. Section 3: Overview of Probabilistic Exposure And Risk Model For Fumigants ( PERFUM) provides a brief summary of the approaches that have been incorporated into the system. Section 4: Charge To Panel details the specific questions pertaining to the use of PERFUM which the Agency would like the SAP panel to address in its deliberations. Page 5 of 23 2 SUMMARY OF CURRENT MODELING APPROACH The goals of the Agency in its fumigant assessment are to develop health protective measures of risk for populations in close proximity to fields that have been treated with soil fumigants as well as to explain and reduce, whenever possible, the uncertainties associated with these analyses. In order to achieve these goals, the Agency first considered monitoring data specific to each chemical but due to the limitations of those data and the flexibility that modeling represents have focused on model results as the key predictor of risks.

The Agency's current exposure assessment approach is based on a deterministic use of the Agency's Industrial Source Complex Model ( ISC) which is routinely used by the Office of Air for regulatory decision making purposes. It is available from the following website at the Technology Transfer Network Support Center for Regulatory Air Models ( or SCRAM) ( http:// www. epa. gov/ scram001/ tt22. htm# isc). ISC is a steady state Gaussian plume model which can be used to assess pollutant concentrations from a wide variety of sources associated with an industrial complex or from other types of sources such as an agricultural field in this case. This model can account for the following: settling and dry deposition of particles; downwash; point, area, line, and volume sources; plume rise as a function of downwind distance; separation of point sources; and limited terrain adjustment. ISC can operate in both long term and short term modes but has been used in the short term mode for the purposes of this assessment.

The Agency's current approach is summarized herein. Section 2.1 Input Variables And Settings Used For ISC Calculations describes the current modeling approaches used by the Agency including a description of the specific inputs and ISC settings used for the calculations. Section 2.2 Outputs Based on Current Modeling Approach provides examples of the outputs from ISC that might be presented for consideration by risk managers. To ensure a level of consistency in the evaluation of the PERFUM model, the examples presented below to describe the current Agency methodology are also based on a case study using iodomethane.

2.1 Input Variables And Settings Used For ISC Calculations In order to define concentration gradients associated with the use of soil fumigants, which are ultimately determinants of exposure, the Agency utilized ISC by equating treated agricultural fields to an area source coupled with inputs that reflected a range of potential atmospheric conditions and application equipment/ techniques used for the different fumigant chemicals. In order to do this, the Agency considered various combinations of four categories of input variables including:

° Field Size; ° Atmospheric Conditions; ° Application Equipment and Control Technologies; and ° Field Emissions Associated With Application Equipment and Control Technology.

[ Note: As a convention, the Agency has used similar input variables for all of the 6 soil fumigant chemicals wherever possible. This allows for an easier determination of the relative risks amongst the 6 soil fumigants. Some input factors such as emission data, however, are by nature chemicalspecific and have been treated as such in analyses completed by the Agency. This is the rationale Page 6 of 23 behind providing a separate section which details how the emission data were analyzed for iodomethane.]

Field Size: The Agency generically is using a range of field sizes for single application events from 1 acre up through 40 acres. Specifically, the Agency based its calculations on field sizes of 1, 5, 10, 20, and 40 acres. It is believed that most distinct soil fumigation application events will be within this range of areas treated. It is also acknowledged larger fields could be treated on a single day. Results could easily be scaled to those larger acreages if needed. These field sizes are also essentially consistent with analyses completed by the California Department of Pesticide Regulation which allows for easy comparison with their results. Field geometry can also impact the results of ISC modeling. For ease, the Agency has by convention completed all of its analyses based on the use of square fields.

Atmospheric Conditions: ISC calculates downwind air concentrations using hourly meteorological conditions, that include wind speed and atmospheric stability ( for a more detailed discussion of stability see http:// www. epa. gov/ scram001/ userg/ relat/ pcramtd. pdf). The higher the letter associated with a stability class the more stable the atmosphere becomes. The lower the wind speed and the more stable the environment, the higher the air concentrations are going to be close to a treated area ( or source). Conversely, if wind speed increases or the atmosphere is less stable, then air concentrations are lowered in proximity to the treated area thereby lowering the potential for exposure. Atmospheric stability is essentially a measure of how turbulent the atmosphere is at any given time. Stability is affected by solar radiation, wind speed, cloud cover, and temperature among other factors. Instability in the atmosphere increases the movement of airborne residues because they are more readily pushed up into the atmosphere and moved away from the source thereby lowering concentrations in close proximity to the source ( e. g., treated field).

In order to simplify modeling the transport of soil fumigant vapors from a treated field, a single wind direction, wind speed, and stability category are used for a given duration of concern ( i. e., 24 hours). The Agency has decided to present a series of results based on a range of possible, and plausible, meteorological conditions to allow for a better characterization of risks compared to just completing the analyses based on a single set of meteorological conditions. The different conditions considered by the Agency are presented in Table 1.

For comparative purposes, the California Department of Pesticide Regulation, in its determination of buffer zones for methyl bromide, based its decisions upon a windspeed of 1.4 m/ s and a class C atmospheric stability value for a 24 hour period. During the daytime hours, Page 7 of 23 these conditions represent a stable atmosphere which is relatively calm but this stability is not considered overly calm for nighttime conditions. We believe these values provide higher end air concentrations. [ Note: This is supported by an analysis methyl bromide buffer zones by DPR available at: www. cdpr. ca. gov/ docs/ dprdocs/ methbrom/ mebrmenu. htm.]

Table 1: Meteorological Combinations Used in ISC Calculations Wind Speed ( mph) Wind Speed ( meters/ second) Stability Category#

2.25^ 1.0^ F^

2.25 1.0 D 3.1* 1.4* C*

4 1.8 C 5 2.2 C 6 2.7 C 7 3.1 C 8 3.6 C 9 4.0 C 10 4.5 C 10 4.5 B # = The lower the assigned " letter" the less stable the atmosphere. Categories A to D are generally seen in daylight conditions. Nighttime conditions are generally even more stable than even the most stable daylight conditions. ^ = Conditions only used for 1 hour exposure duration. * = Conditions used in DPR assessment and risk management decisions for methyl bromide.

Application Equipment and Control Technologies: Application equipment and control technologies are varied and depend on many factors including the environmental fate characteristics of the chemical, terrain where the chemical is being used, economic considerations, and other agricultural practices. Application equipment can take many forms but applications typically involve the use of some sort of probe that is used to inject material beneath the surface of the soil, a broadcast application of a liquid solution or solid material across the surface of a treated area, or the delivery of chemicals through some sort of plumbed system throughout the treated area ( e. g., some chemicals are delivered via irrigation water). Page 8 of 23 Along with the various application methods there are a number of control technologies that are intended to minimize the emissions from treated fields. These can take many forms but essentially involve one of three basic techniques that include: ( 1) change in injection depth and probe design; ( 2) use of tarping or bedding techniques; and ( 3) watering in.

Ultimately, the goal of the Agency is to codify different combinations of application methods and control technologies in order to have these serve as a systematic basis for risk assessments. The ability to do this, however, varies depending upon the data available for each chemical. In some cases, such as methyl bromide, there is a preponderance of data that allows for characterization based on a large number of possibilities as described by the California Department of Pesticide Regulations in its permit conditions which are presented on their website ( http:// www. cdpr. ca. gov/ docs/ legbills/ mebrbuffer. pdf).

The situation with iodomethane differs somewhat in that it has not been registered yet with any regulatory agency so no permit conditions or official labeling exists at this point. To complete its analysis, the Agency used proposed label language and the monitoring data that are available. The available data have been reviewed and three basic categories of application methods have been identified to date ( Table 2).

Table 2: Summary Of Application Methods For Iodomethane Application Method Emission Reduction Technology Combination #

Shallow shank, broadcast flat fume Tarped 1 Shallow shank, raised bed Tarped 2 Drip irrigation, raised bed Tarped 3 Field Emissions Associated With Application Equipment and Control Technology: Emissions from treated fields are generally characterized as the amount of residues that are offgassing from a unit area per unit time. Emissions quantified in this manner are referred to as flux (

g/ m2 s). Flux rates are specific to the conditions of the field experiment for which they were generated but can be used in a generic sense by normalizing the data to the maximum application rate which was 175 pounds per acre. Flux rates were calculated using the backcalculation method with ISC. The ISC back calculation method estimates flux rates by extrapolating from the available field air monitoring data, assuming a Gaussian plume distribution, to estimate the flux rate. The normalized flux rates which were determined for iodomethane are summarized below in Table 3. Page 9 of 23 Table 3: Summary Of Normalized Flux Rates For Iodomethane Application Method Emission Reduction Technology 24 Hour Flux Rates (

g/ m2  s) Combination #

Shallow shank, broadcast flat fume Tarped 107 ( Manteca Site Data) 1 Shallow shank, raised bed Tarped 85 2 Drip irrigation, raised bed Tarped 66 3 Note: These values are subject to change as the Agency was finalizing these calculations during the time this document was prepared. Detailed information concerning these flux calculations will be presented by the Agency at the SAP meeting during introductory remarks.

Other Settings/ Parameters: Along with the input variables described above that have been considered by the Agency in this assessment there are other parameters ( or settings) that must be defined in order to complete an ISC analysis. These parameters include ( see Figure 1):

° Rural conditions are used;

° Mixing height 692 m for rural settings ( based on DPR analysis);

° Receptor height at ground level ( similar to DPR analysis);

° Source ( i. e., the treated field) is treated as an area source;

° Source ( i. e., the treated field) is square oriented in north/ south direction;

° Grid origin is SW corner of field;

° Receptors are centerline of field to the south, buffers are from edge of field;

° Release height is 0 meters;

° Flux rates determined from monitoring data using ISC based back calculation method as no direct measurements of flux were available for this analysis ( i. e., sometimes referred to as indirect flux calculation method);

° Deposition is not accounted for and is expected to be minimal due to volatility of chemical; and ° Standard regulatory default options as defined in ISC User's Guide Volume 1 have been used. Page 10 of 23 2.2 Outputs Based on Current Modeling Approach Examples of the kinds of outputs which can be generated by ISC based on inputs similar to those described above are presented in this section. For the purposes of this example, the outputs represent 24 hour average concentrations at selected downwind receptor points. The receptor points are illustrated in Figure 1 along with the unidirectional nature of the meteorological conditions ( i. e., wind direction) upon which the assessment is based. Page 11 of 23 The results based on the Agency's methodology were calculated using a test case similar to one of those included as a case study in the PERFUM background document. The test case which was evaluated considered the exposures of individuals surrounding a field that had been treated via a tarped shallow shank, broadcast flat fume application. For comparative purposes, the Agency has summarized the results based on its deterministic approach for this scenario below. These results include air concentrations (

g/ m3) at selected receptor points downwind for a variety of meteorological conditions ( Table 4). The conditions considered in this analysis range from a stable atmosphere conducive to higher concentrations in close proximity to treated areas to conditions that are much less stable which lead to lower concentrations in proximity to treated areas.

Table 4: ISC Calculated Air Concentrations At Selected Distances Downwind (

g/ m3) For Pre Plant Agricultural Field Fumigations ER Fld Size ( A) DW Dist. ( M) Air Concentrations At Differing Meteorological Conditions 1 m/ s 2.3 mph 1.4 m/ s 3.1 mph 1.8 m/ s 4 mph 2.2 m/ s 5 mph 2.7 m/ s 6 mph 3.1 m/ s 7 mph 3.6 m/ s 8 mph 4.0 m/ s 9 mph 4.5 m/ s 10 mph 4.5 m/ s 10 mph Stab D Stab C Stab C Stab C Stab C Stab C Stab C Stab C Stab C Stab B 0.47 1 25 2116 976 759 621 506 441 380 342 304 214 100 935 395 307 251 205 178 153 138 123 73 500 170 48 37 30 25 22 19 17 15 6 1000 59 15 11 9.4 7.6 6.6 5.7 5.1 4.6 1.7 2500 15 2.9 2.3 1.8 1.5 1.3 1.1 1.0 0.9 0.3 5000 5.3 0.8 0.6 0.5 0.4 0.4 0.3 0.3 0.3 0.1 40 25 5278 2342 1822 1491 1215 1058 911 820 729 507 100 3314 1418 1103 902 735 640 551 496 441 300 500 1456 564 438 359 292 255 219 197 175 99 1000 942 309 240 196 160 139 120 108 96 43 2500 434 93 72 59 48 42 36 32 29 9.7 5000 186 30 23 19 16 14 12 11 9.4 3.4 Note: ER = emission rate which defines flux in terms of the percentage of the amount applied. The emission rate of 47 percent or 0.47 for this application method was calculated by dividing the flux rate of 107

g/ meter squared  second by the application rate of 175 pounds/ acre/ day after conversion to similar units and adjustment of the flux rate to a 24 hour value. The flux data upon which this analysis is based is from the Manteca flat fume study. There was another flat fume application study available that was conducted in Watsonville California. However, for illustrative purpose, the Agency has provided concentration estimates based on the Manteca information. Page 12 of 23 The air concentrations presented in Table 4 would then be used to calculate a risk estimate for each condition. The Agency uses Margins of Exposure to represent non cancer risks which are calculated using the following formula:

MOE = HEC (

g/ m3) Air Concentration (

g/ m3)

Where:

MOE = Margin of exposure, value used to represent risk or how close a chemical exposure is to being a concern ( unitless); Air Concentration = The concentration in air to which an individual could be exposed (

g/ m3); and HEC = Human equivalent concentration is the air concentration of a toxicant at a level at which an effect might occur ( e. g., NOAEL or LOAEL) after it has been adjusted to pharmacokinetic differences between the test animal species and humans.

In the PERFUM case study a " threshold" HEC value was used for the purposes of calculating simulated risk estimates 120

g/ m3. This does not represent the actual HEC or " threshold" being considered by the Agency at this point and is only used for illustrative purposes. The Agency wishes to focus discussion at the SAP meeting on the methodologies contained in PERFUM that could potentially lead to an evolution in the manner in which the Agency calculates exposure concentrations such as in Table 4 and not on other risk assessment related issues specific to the iodomethane case study example. As such, the Agency has not included any risk estimates in this document for the case study. Page 13 of 23 3 OVERVIEW OF Probabilistic Exposure And Risk Model For Fumigants ( PERFUM)

The Probabilistic Exposure And Risk Model For Fumigants ( PERFUM) is a modeling tool that could potentially represent an evolution in the manner in which the Agency calculates exposures from soil fumigants. It is the methodologies included in PERFUM that the Agency wishes the SAP panel to consider in its deliberations. This section contains a very brief overview of the PERFUM system and how the outputs might differ from those generated using the current Agency approach for calculating exposures. Definitive discussions of PERFUM can be found in the following ( http:// www. epa. gov/ oscpmont/ sap/ 2004/# top).

A Probabilistic Exposure And Risk Model For Fumigant Bystander Exposures Using Iodomethane As A Case Study, Reiss and Griffin, July, 2004 The purpose of this discussion is to provide readers with a way to easily contrast the Agency approach and the approaches included in PERFUM. Much of the discussion in this section and the graphics included herein are excerpted directly from the above document. It should also be noted that the PERFUM developers used data specific to the soil fumigant, iodomethane, as the basis for the case study included in this document ( i. e., exposures were evaluated for each of the different categories of application methods described above in Table 2). The Agency believes that the methods applied in this analysis have generic applicability to all fumigants and wishes that PERFUM be considered in this manner yet keeping in mind that some of the inputs used for this analysis have to be specific to iodomethane in order to complete the case study analysis.

The PERFUM model was developed with three critical design considerations in mind including: ( 1) integration of actual meteorological data into an analysis; ( 2) the variability associated with emissions from treated fields; and ( 3) the need to evaluate uncertainty associated with the input parameters throughout a modeling analysis. PERFUM is based on an EPA model ( ISCST). The PERFUM approach utilizes historical meteorological datasets and provides characterization of the potential downwind concentrations. Specifically, for an emission profile, PERFUM calculates the downwind concentrations in all directions around the field for every day for a 5 year period for every source of meteorological data considered. From these concentration calculations, PERFUM establishes distances from the field, in all directions, where the concentration declines to a user defined threshold. The PERFUM " modeling toolbox" also contains an additional program that can calculate margins of exposure ( MOEs) for a defined concentration isopleth around a treated field. Page 14 of 23 Specifically, in the case study developed based on iodomethane, the following options/ inputs were considered:

° Flux data from 6 distinct field monitoring studies that evaluated emissions from flat fume, raised bed, and drip irrigation applications; ° Emissions on the day of application and the days immediately following were considered; ° Direct and indirect flux estimates for the Manteca study were compared; ° Meteorological data from 4 sources including National Weather Service, Automated Surface Observing System, California Irrigation Management Information System, and Florida Automated Weather Network were considered; ° The impact of mixing height and the replacement of missing meteorological data were evaluated; and ° An uncertainty analysis was completed that evaluated emission inputs, meteorology and other general modeling issues such as the treatment of " calm wind" periods; terrain impacts; seasonal variation in applications, and exposures from multiple fields.

The following graphically describe a number of issues that were considered in the development of PERFUM, analysis of the data, interpretation of the results compared to the current Agency practice. Figure 2 provides a description of the receptor grid which is used in the PERFUM analysis. Table 5 provides numerical estimates for the number of receptors considered in a PERFUM analysis.

Table 5. Receptor Points for Various Field Sizes Grid Type Field Size ( acres) Number of Spokes Number of Rings Number of Receptors ( Spokes* Distances)

Fine 1 96 28 2,688 5 132 28 3,696 10 152 28 4,256 20 188 28 5,264 40 232 28 6,496 Coarse 1 24 28 672 5 33 28 924 10 38 28 1,064 20 47 28 1,316 40 58 28 1,624 Page 15 of 23 Figure 2. Receptor Grid For A 5 Acre Field ( 5 acre field in center; blue line is an example of a spoke) Page 16 of 23 Figure 3 provides a comparison of emission rates from two fields treated via flat fume application. This figure also illustrates variability in emissions and a general decline in air concentrations over time. It should also be noted that Manteca data were selected as the basis for the analysis conducted by the Agency.

Figure 3. Estimated Flux Rate Versus Mean Time Since Application For Flat Fume Applications Page 17 of 23 Figures 4 and 5 provide a summary of the meteorological data used for the PERFUM analysis. Figure 4 illustrates the locations of the meteorological stations that were considered as sources of data in Southern California which is anticipated to be an area of substantial iodomethane use. Figure 5 presents windrose data for the Bakersfield ASOS station which illustrates how wind directions and speed changed over the selected period at that station.

Figure 4. Locations of Meteorological Stations in California Page 18 of 23 Figure 5. Wind Rose Plot For Bakersfield Page 19 of 23 Figure 6 provides a comparison of the distributions of daily average windspeeds for selected meteorological stations in both California and Florida. Note that the results of this analysis can be used to assist in the characterization of the deterministic inputs used by the Agency and summarized in Table 4 Figure 6. Distribution Of Daily Average Wind Speeds at the Meteorological Stations Page 20 of 23 Figure 7 provides an example of the isopleths that can be produced using PERFUM. The example provided below is for a 5 acre field. It also illustrates how the results can be used for regulatory purposes and for examination of exposures which may exceed any specified threshold concentration.

Figure 7. Example Concentration Estimates For A 5 Acre Field ( Red line shows contour at reference concentration; black line shows the buffer zone). Page 21 of 23 4 CHARGE TO PANEL This section presents the charge questions the Agency wishes the panel to consider in its deliberations pertaining to PERFUM. The nature of these questions are varied and range from issues pertaining to the documentation, design, and operation of PERFUM to the manner in which results are presented. For simplicity, the Agency has grouped the questions by subject matter that reflect critical elements pertaining to the use of PERFUM and results generated by PERFUM. The key subject matter areas include: ( 1) documentation; ( 2) system design/ inputs; and ( 3) how results are presented.

Critical Element 1: Documentation Question 1: The background information presented to the SAP panel by the PERFUM developers provides both user guidance and a technical overview of the system. Please comment on the detail and clarity of this document. Are the descriptions of the specific model components scientifically sound? Do the algorithms in the annotated code perform the functions as defined in this document? Please discuss any difficulties encountered with respect to loading the software and evaluating the system including the presented case study?

Critical Element 2: System Design/ Inputs Question 2: In Section 2.3: Development of the PERFUM Modeling System of the background document, a series of detailed individual processes and components included in PERFUM are presented. The key processes include ( 1) incorporation of ISCST3 into PERFUM, ( 2) probabilistic treatment of flux rates; and ( 3) development of a receptor grid. Please comment on these proposed processes, the nature of the components included in PERFUM and the data needed to generate an analysis using PERFUM? Are there any other potential critical sources of data or methodologies that should be considered?

Question 3: The determination of appropriate flux/ emission rates is critical to the proper use of the PERFUM model as these values define the source of fumigants in the air that can lead to exposures. Upon its review of how flux rates can be calculated, the Agency has identified a number of questions it would like the panel to consider. In PERFUM, flux rates were treated as a probabilistic variable with an uncertainty developed from the statistical bounds of the flux calculation. For each measurement period a standard error is generated that reflects the measurement uncertainty of the flux rate. PERFUM then perturbs the concentration estimates within each period by the standard error using Monte Carlo methods to simulate the uncertainty in the flux estimates. What, if any, refinements are needed for this process including the manner in which flux values were calculated for each monitoring period to generate the standard error estimates? How appropriate is it to use a flux/ emission factor from a single monitoring study ( or Page 22 of 23 small number of studies) and apply it to different situations such as for the same crop in a different region of the country? Please comment on PERFUM's capability to adequately consider multiple, linked application events as well as single source scenarios? Does PERFUM appropriately address situations where data are missing? In the back calculation approach used for estimating emission rates, the regression of measured versus modeled values can be forced through the origin or not. Which approach does the panel prefer and what are the implications of each approach?

Question 4: The integration of actual time base meteorological data into ISCST3 is one of the key components that separates the PERFUM methodology from that being employed by the Agency in its current assessment. There are several potential sources of these data including the National Weather Service, Federal Aviation Administration, California Irrigation Management Information System ( CIMIS), and the Florida Automated Weather Network ( FAWN). The Agency is also aware that there are several approaches that can be used to process meteorological data and acknowledges that PERFUM used PCRAMMET which is a standard Agency tool for this purpose as well as other techniques in some cases ( e. g., for the FAWN & CIMIS data). Various datasets from both California and Florida were used as the basis for the PERFUM case study. Please comment on the methods used to select monitoring station locations? What criteria should be used to identify meteorological regions for analysis and how should specific monitoring data be selected from within each region.? Please comment on the manner that data from the selected various stations were processed? Data quality and uncertainty associated with these data vary with the source. Does the panel agree with the approaches used to characterize these factors? Anemometer sampling height has been identified as a concern by the Agency in preparation for this meeting. What are the potential impacts of using data collected with different anemometer heights in an analysis of this nature? Does PERFUM treat stability class inputs appropriately? Does PERFUM appropriately calculate bounding air concentration estimates by concurrently using upper bound meteorological and emission/ flux inputs?

Question 5: The Agency model, ISCST3 is the basis for the PERFUM approach. This model has been peer reviewed and is commonly used for regulatory purposes by the Agency. PERFUM also uses other Agency systems such as PCRAMMET. Please recommend any parameters that should be altered to optimize the manner that they are used in PERFUM? Does the panel agree with the manner in which the receptor grid was developed, and if not, please provide suggestions for improving this approach? ISCST3, as integrated into PERFUM, was run assuming rural, flat terrain which would be typical of treated farm fields but might not be typical of surrounding residential areas. Does the panel concur with this approach? What are the implications of such an approach? What improvements can be made to this approach? ISCST3, as integrated into PERFUM, was run in regulatory mode which includes the use of the " calms" processing routine. Does the panel concur with this approach? If not, please suggest a suitable alternative?

Critical Element 3: Results Question 6: Soil fumigants can be used in different regions of country under different conditions and they can be applied with a variety of equipment. Please comment on whether the methodologies in PERFUM can be applied generically in order to assess a wide variety of fumigant uses? What considerations with regard to data needs and model inputs should be Page 23 of 23 considered for such an effort?

Question 7: Please comment on whether PERFUM adequately identifies and quantifies airborne concentrations of soil fumigants that have migrated from treated fields to sensitive receptors? The Agency is particularly concerned about air concentrations in the upper ends of the distribution. Are these results presented in a clear and concise manner that would allow for appropriate characterization of exposures that could occur at such levels? The PERFUM model calculates the concentration distributions both in all directions and for only the maximum concentration direction. Can the panel comment on how accurately the model approximates both of these distributions?

Question 8: A sensitivity/ uncertainty analysis has been conducted and is described in the PERFUM background document. What types, if any, of additional contribution/ sensitivity analyses are recommended by the panel to be the most useful in making scientifically sound, regulatory decisions? What should be routinely reported as part of a PERFUM assessment with respect to inputs and outputs? Are there certain tables and graphs that should be reported? What types of further evaluation steps does the panel recommend for PERFUM?


[Federal Register Volume 87, Number 26 (Tuesday, February 8, 2022)]
[Notices]
[Pages 7239-7240]
[FR Doc No: 2022-02629]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-25854; FMCSA-2010-0203; FMCSA-2013-0106; FMCSA-
2013-0107; FMCSA-2013-0108; FMCSA-2015-0117; FMCSA-2015-0119; FMCSA-
2017-0178; FMCSA-2017-0181; FMCSA-2017-0251; FMCSA-2018-0052]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to renew exemptions for 14
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates provided
below.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-
0001. Office hours are from 8:30 a.m. to 5 p.m., ET, Monday through
Friday, except Federal holidays. If you have questions regarding
viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-2006-25854, FMCSA-2010-0203, FMCSA-2013-0106, FMCSA-2013-
0107, FMCSA-2013-0108, FMCSA-2015-0117, FMCSA-2015-0119, FMCSA-2017-
0178, FMCSA-2017-0181, FMCSA-2017-0251, or FMCSA-2018-0052 in the
keyword box, and click ``Search.'' Next, sort the results by ``Posted
(Newer-Older),'' choose the first notice listed, and click ``Browse
Comments.'' If you do not have access to the internet, you may view the
docket online by visiting Dockets Operations in Room W12-140 on the
ground floor of the DOT West Building, 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., ET, Monday
through Friday, except Federal holidays. To be sure someone is there to
help you, please call<PHONE_NUMBER> or<PHONE_NUMBER> before visiting
Dockets Operations.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its regulatory process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    On December 29, 2021, FMCSA published a notice announcing its
decision to renew exemptions for 14 individuals from the epilepsy and
seizure disorders prohibition in 49 CFR 391.41(b)(8) to operate a CMV
in interstate commerce and requested comments from the public (86 FR
74211). The public comment period ended on January 28, 2022, and no
comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that renewing these exemptions would achieve a level of
safety equivalent to, or greater than, the level that would be achieved
by complying with Sec.  391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in Sec.  391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical

history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based on its evaluation of the 14 renewal exemption applications,
FMCSA announces its decision to exempt the following drivers from the
epilepsy and seizure disorders prohibition in Sec.  391.41(b)(8).
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of December
and are discussed below.
    As of December 16, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following 11 individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers (86 FR
74211):

Eric Barnwell (MI)
Christopher Bird (OH)
Gary Clark (KY)
Todd Davis (WI)
Scott DeJarnette (KY)
Gary J. Gress (PA)
Curtis Alan Hartman (MD)
Wendell F. Headley (MO)
Jason Kirkham (WI)
Dannie Kuck (MT)
Robert Spencer (FL)

    The drivers were included in docket number FMCSA-2010-0203, FMCSA-
2013-0106, FMCSA-2013-0107, FMCSA-2015-0117, FMCSA-2015-0119, FMCSA-
2017-0178, FMCSA-2017-0181, FMCSA-2017-0251, or FMCSA-2018-0052. Their
exemptions were applicable as of December 16, 2021 and will expire on
December 16, 2023.
    As of December 23, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following three individuals have satisfied the
renewal conditions for obtaining an exemption from the epilepsy and
seizure disorders prohibition in the FMCSRs for interstate CMV drivers
(86 FR 74211):

Gary Freeman (WI)
Aaron Gillette (SD)
David Kestner (VA)

    The drivers were included in docket number FMCSA-2006-25854 or
FMCSA-2013-0108. Their exemptions were applicable as of December 23,
2021 and will expire on December 23, 2023.
    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2022-02629 Filed 2-7-22; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 75, Number 247 (Monday, December 27, 2010)]
[Notices]
[Pages 81282-81283]
[FR Doc No: 2010-32367]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Circulatory System Devices Panel of the Medical
Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on January 25 and 26, 2011,
from 8 a.m. to 6 p.m.
    Location: Holiday Inn, Main Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD. Information regarding special accommodations due to a
disability, visitor parking and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``White Oak Conference Center Parking
and Transportation Information for FDA Advisory Committee Meetings.''
Please note that visitors to the White Oak Campus must enter through
Building 1.
    Contact Person: James Swink, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993, or FDA Advisory Committee Information Line, 1-800-
741-8138<PHONE_NUMBER> in the Washington, DC area), code<PHONE_NUMBER>.
Please call the Information Line for up-to-date information on this
meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the Agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
    Agenda: On January 25, 2011, the committee will discuss and make
recommendations regarding regulatory classification of Automated
External Defibrillators to either reconfirm to class III (subject to
premarket approval application (PMA)) or reclassify to class II
(subject to premarket notification (510(k))), as directed by section
515(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360e(i)).
    On January 26, 2011, the committee will discuss, make
recommendations and vote on information related to the PMA supplement
for the RX Acculink Carotid Stent System, sponsored by Abbott Vascular.
The RX Acculink is indicated for treatment of patients at high and
standard risk for adverse events from carotid endarterectomy who
require carotid revascularization and meet the criteria outlined as
follows:
    1. Patients with neurological symptoms and >50 percent stenosis of
the common or internal carotid artery or patients without neurological
symptoms and >80 percent (high risk) or >70 percent (standard risk)
stenosis of the common or internal carotid artery and
    2. Patients must have a reference vessel diameter within the range
of 4.0 and 9.0 mm at the target lesion.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
January 18, 2011. Oral presentations from the public will be scheduled
for 1 hour at approximately 1 p.m., immediately following lunch on both
days. Those individuals interested in making formal oral presentations
should notify the contact person and submit a brief statement of the
general nature of the evidence or arguments they wish to present, the
names and addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on

or before January 10, 2011. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by January
11, 2011.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Conference Management Staff,<PHONE_NUMBER>, at least 7 days in advance
of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: December 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32367 Filed 12-23-10; 8:45 am]
BILLING CODE 4160-01-P