[Federal Register Volume 87, Number 149 (Thursday, August 4, 2022)]
[Rules and Regulations]
[Pages 47624-47626]
[FR Doc No: 2022-16634]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[[Docket Number USCG-2022-0275]
RIN 1625-AA00

Safety Zone; Cumberland River, Nashville, TN

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is establishing to a temporary safety zone
from mile marker 191.1 to 191.5 of the Cumberland River. This action is
necessary to provide for the safety of life on these navigable waters
near Korean Veterans Bridge, Nashville, TN, during Music City Grand
Prix on August 5 through August 7, 2022. This rulemaking prohibits
persons and vessels from being in the safety zone unless authorized by
the Captain of the Port Sector Ohio Valley or a designated
representative.

DATES: This rule is effective every day from 2 p.m. August 5, 2022 p.m.
through 4:30 p.m. August 7, 2022. See SUPPLEMENTARY INFORMATION for
specific daily enforcement times.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0275 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Petty Officer Third Class Benjamin
Gardner and Marine Safety Detachment Nashville, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard was notified by Indy Car of a proposed racing event
that goes over the Cumberland River. The event would take place from
August 5, 2022 to August 7, 2022. On August 5, 2022 the river closure
would be from 2 p.m.

until 6:30 p.m. On August 6, 2022 the river closure would be from 11
a.m. until 5 p.m. On August 7, 2022 the river closure would be from 2
p.m. until 4:30 p.m. The Captain of the Port Sector Ohio Valley (COTP)
has determined that there is a need to protect the river users while
the Indy cars are on the track between mile marker 191.1 and mile
marker 191.5 on the Cumberland River. In response, on April 20, 2022,
the Coast Guard published a notice of proposed rulemaking (NPRM) titled
Safety Zone; Cumberland River, Nashville, TN, USCG-2022-0275 (87 FR
24486). There we stated why we issued the NPRM, and invited comments on
our proposed regulatory action related to this Indy Car race. During
the comment period that ended May 26, 2022, we received 1 comment.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Ohio
Valley (COTP) has determined that potential hazards associated with the
Indy Car race will be a safety concern for anyone within a 0.4 mile
radius of the Korean Veterans Bridge. The purpose of this rule is to
ensure safety of vessels and the navigable waters in the safety zone
before, during, and after the scheduled event.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received 1 comment on our NPRM published April
26, 2022. The comment stated,'' We think this is a smart idea because
the Coast Guard is accounting for the safety of the citizens in the
Nashville area during these dates. Thank you for not only keeping our
international waters safe but for also keeping us protected and secure
close to home.'' This comment does not have any effect on our proposed
rule and does not require any changes to the final rule.
    This rule establishes a safety zone from that will be enforced from
2 p.m. until 6:30 p.m. on August 5, 2022, from 11 a.m. until 5 p.m. on
August 6, 2022, and from 2 p.m. until 4:30 p.m. on August 7, 2022. The
safety zone would cover all navigable waters within 0.4 miles of the
Korean Veterans Bridge on the Cumberland River in Nashville, TN. The
duration of the zone is intended to ensure the safety of vessels and
these navigable waters before, during, and after the scheduled Indy Car
races. No vessel or person will be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. The regulatory text we are proposing appears at the end
of this document.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. The safety zone
will be 13 hours spread over the course of 3 days during daylight hours
in Nashville, TN. The safety zone will only encompass .4 miles of the
Cumberland River. Vessel traffic will be able to safely transit around
this safety zone which would impact a small designated area of the
Cumberland River before or after the time of the events on each day.
Moreover, the Coast Guard would issue a Broadcast Notice to Mariners
via VHF-FM marine channel 16 about the zone, and the rulemaking would
allow vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received 0 comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of
1969(42 U.S.C. 4321-4370f), and have determined that this action is one
of a category of actions that do not individually or cumulatively have
a significant effect on the human environment. This rule involves 3
separate safety zones over the course of 3 days that in total will last
for 13 hours. It is categorically excluded from further review under
paragraph L[60] of Appendix A, Table 1 of DHS Instruction Manual 023-
01-001-01, Rev. 1. A Record of Environmental Consideration supporting
this determination is available in the docket. For instructions on
locating the docket, see the ADDRESSES section of this preamble.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
0170.1., Revision No. 01.2.

0
2. Add Sec.  165.T08-0275 to read as follows:

Sec.  165.T08-0275  Safety Zone; Cumberland River, Nashville, TN

    (a) Location. The following area is a safety zone: all navigable
waters of the Cumberland River, Mile Markers 191.1-191.5, extending the
entire width of the river.
    (b) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by VHF Channel 16. Those in the safety zone must comply
with all lawful orders or directions given to them by the COTP or the
COTP's designated representative.
    (c) Enforcement period. This section will be enforced on:
    (1) August 5, 2022 from 2 p.m. until 6:30 p.m.;
    (2) August 6, 2022 from 11 a.m. until 5 p.m.; and
    (3) August 7, 2022 from 2 p.m. until 4:30 p.m.

    Dated: July 25, 2022.
H.R. Mattern,
Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2022-16634 Filed 8-3-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 176 (Monday, September 12, 2016)]
[Rules and Regulations]
[Pages 62801-62806]
[FR Doc No: 2016-21377]

Vol. 81

Monday,

No. 176

September 12, 2016

Part II

Department of Transportation

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Federal Aviation Administration

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14 CFR Part 93

14 CFR Part 71

Pearson Field Airport Special Flight Rules Area and Revocation of Class
D Airspace; Vancouver, WA; Final Rules

Federal Register / Vol. 81 , No. 176 / Monday, September 12, 2016 /
Rules and Regulations

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 93

[Docket No.: FAA-2015-3980; Amdt. No. 93-100]
RIN 2120-AK74

Pearson Field Airport Special Flight Rules Area

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is establishing a Special Flight Rules Area in the
vicinity of Pearson Field Airport, Vancouver, Washington. Pearson Field
Airport is located approximately three nautical miles northwest of
Portland International Airport, Portland, Oregon. The close proximity
of the airport traffic patterns and approach courses create converging
flight paths between traffic on approach to Portland International
Airport and traffic at Pearson Field Airport, increasing the risk for
near mid-air collision, mid-air collision and wake turbulence events.
The intended effect of this action is to mitigate the identified risk
by establishing operating requirements applicable to all aircraft when
operating within a designated area at Pearson Field Airport, which
would increase overall system efficiency and safety.

DATES: Effective November 10, 2016, except for amendatory instruction
#1, which is effective September 12, 2016.

ADDRESSES: For information on where to obtain copies of rulemaking
documents and other information related to this final rule, see ``How
to Obtain Additional Information'' in the SUPPLEMENTARY INFORMATION
section of this document.

FOR FURTHER INFORMATION CONTACT: Patrick Moorman, Airspace and Rules
Team, AJV-115, Federal Aviation Administration, 800 Independence Avenue
SW., Washington, DC 20591; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

    This rule establishes a special flight rules area (SFRA) around
Pearson Field Airport (Pearson Field) in which pilots will have to
follow mandatory procedures. These procedures are necessary to assist
in the separation of air traffic, and to ensure pilots are aware of
potential traffic conflicts between aircraft operating at Pearson Field
and Portland International Airport. The notice of proposed rulemaking
(NPRM) was published on October 6, 2015. 80 FR 60310. The FAA received
16 comments to the NPRM. All but one of the commenters supported
creation of the special flight rules area for Pearson Field. However,
those commenters believed that findings from the Safety Risk Management
Panel for Pearson Field should be expressly included in the regulation.
Based on the comments received, the FAA has made one minor change to
proposed 14 CFR 93.163 regarding operations over the runway or extended
runway centerline of Pearson Field. This final rule will ensure safety
of flight for aircraft operating at Pearson Field Airport and the
adjacent Portland International Airport.

II. Authority for This Rulemaking

    The FAA's authority to issue rules on aviation safety is found in
Title 49 of the United States Code (49 U.S.C.). 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 49
U.S.C. 106(f), which establishes the authority of the Administrator to
promulgate regulations and rules. This rulemaking also is promulgated
under the authority described in 49 U.S.C. 40103, which vests the
Administrator with broad authority to prescribe regulations to assign
the use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace, and 49 U.S.C. 44701(a)(5), which requires
the Administrator to promote safe flight of civil aircraft in air
commerce by prescribing regulations and minimum standards for other
practices, methods, and procedures necessary for safety in air commerce
and national security.

III. Background and History

    Pearson Field is located on the north bank of the Columbia River in
Vancouver, Washington, approximately three nautical miles west of
Portland International Airport, Portland, Oregon. Pearson Field is part
of the Fort Vancouver National Historic Site, and is listed on the
National Register of Historic Places. It is one of the oldest airports
in the United States, and the longest continually operating airport
west of the Mississippi. Pearson Field does not have an air traffic
control tower.
    Portland International Airport is located 10 miles northeast of
downtown Portland and has over 300,000 annual operations, primarily
scheduled air carriers conducting operations under Title 14 of the Code
of Federal Regulations (14 CFR) part 121. It serves northern Oregon and
southwest Washington with service to 120 cities worldwide. Due to the
continued growth of Portland International Airport and the close
proximity of Pearson Field, the FAA has identified safety issues.
    The airspace area surrounding Pearson Field is excluded from the
Portland International Airport Class C airspace area and is commonly
referred to as the Pearson cutout. The runway 08 threshold at Pearson
Field is directly below the instrument landing system (ILS) final
approach course to Portland International Airport's runway 10L.
Additionally, runway 10L was expanded to accommodate heavy aircraft and
Boeing 757s. These operations increase the risk of wake turbulence
events between Portland International Airport arrivals to runway 10L or
departures from runway 28L/28R and aircraft operating at Pearson Field.
    The Airport/Facility Directory (A/FD) lists the traffic pattern
altitude at Pearson Field as 1029 feet mean sea level (MSL) or 1000
feet above ground level (AGL). The A/FD also instructs aircraft
operating over the runway centerline or extended runway centerline at
Pearson Field to ``maintain at or below 700 feet MSL due to traffic and
wake turbulence from overflying aircraft to/from Portland International
Airport Runway 10L/28R.'' This is because aircraft established on the
Portland International Airport ILS final approach course to runway 10L
pass directly over Pearson's runway 08 threshold at 1091 feet MSL (1062
feet AGL). The close proximity of the traffic pattern and the approach
course create converging flight paths between aircraft on approach to
Portland International Airport's runway 10L/10R and aircraft operating
at Pearson Field.
    These converging flight paths and the lack of vertical separation
create potential safety concerns for aircraft operating at both Pearson
Field and Portland International Airport, including risk of mid-air
collision and wake turbulence events. Currently, there is no
requirement for pilots to establish communications with air traffic
control to receive traffic advisories. In particular, when Portland
International Airport is operating on an east traffic flow and weather
permits aircraft to operate under visual flight rules (VFR) at Pearson
Field the occurrence of traffic collision avoidance system (TCAS)
resolution advisories (RA) increases.
    To mitigate the identified risk, FAA's Portland Approach Control
took

measures to increase safety, which included training controllers
regarding flight paths into and out of Pearson Field, and refresher
training regarding RAs, safety alerts and wake turbulence. Portland Air
Traffic Control Tower established the ``Pearson Advisory'' position to
provide traffic advisories to aircraft operating at Pearson Field.
Additionally, recommended pilot communications and procedures were
placed in the A/FD, which are voluntary but not required. While these
mitigations have increased safety and pilot awareness, 20 TCAS RAs were
reported and logged by air traffic control during calendar year 2014,
and 18 TCAS RAs were reported and logged during calendar year 2015,
reflecting an ongoing safety concern.

IV. The Final Rule

a. The Notice of Proposed Rulemaking

    To address the safety concerns between traffic operating at Pearson
Field and Portland International Airport, the FAA published a notice of
proposed rulemaking to establish a SFRA at Pearson Field by adding new
subpart N to part 93, where special air traffic rules are codified. 80
FR 60310 (October 6, 2015). The proposed rule provided a description of
the airspace area (proposed Sec.  93.162), communication requirements
in the SFRA for both inbound and outbound flights (proposed Sec.
93.163(a)), and procedural requirements necessary to reduce the risks
associated with the operation (proposed Sec.  93.163(c)).
    That NPRM proposed to make the following voluntary practices in the
A/FD and air traffic procedures applicable in the Pearson Field SFRA
and mandatory for all pilots unless otherwise authorized by Air Traffic
Control (ATC):
     Pilots must establish two-way radio communications with
Pearson Advisory on the common traffic advisory frequency for the
purpose of receiving air traffic advisories prior to entering the SFRA
or taxiing onto the runway for departure. Additionally, pilots must
continuously monitor the frequency at all times while operating within
the designated airspace.
     When operating over the extended centerline of Pearson
Field Runway 8/26, pilots must maintain an altitude at or below 700
feet MSL.
     Pilots must obtain the Pearson Field weather prior to
establishing two-way communications with Pearson Advisory.
     Pilots must remain outside Portland Class C Airspace.
     Pilots must make a right-hand traffic pattern when
operating to/from Pearson Field Runway 26.
     Pilots may operate in the area without establishing two-
way radio communication, in the event of radio failure, provided that
weather conditions at Pearson Field are at or above basic VFR weather
minimums.

B. Comments Received

    The FAA received sixteen comments to the NPRM: Nine from
individuals (one individual submitted two comments, and another
individual submitted three comments); and four comments from
organizations: The Port of Portland, Washington Airport Management
Association, the Pearson Field Airport Manager, and the Aircraft Owners
and Pilots Association. Four of the nine individuals who commented to
the notice of proposed rulemaking had previously participated in Safety
Risk Management Panels related to Pearson Field.
    One individual commenter supported the NPRM without change. Seven
individuals and the four organizations expressed general support for
the rulemaking action. All of the comments supporting the NPRM
discussed concerns regarding the proposed rule and recommended changes
to more closely align the rule with current safety risk management
procedures. One individual commenter opposed the NPRM. A discussion of
the comments received and FAA's responses follows.
    The 2012 safety risk management panel and the proposed rule: The
Port of Portland, Washington Airport Management Association, Pearson
Field Airport Manager, Aircraft Owners and Pilots Association, and six
individual commenters--four of whom had participated in previous Safety
Risk Management Panels--supported replacing the Class D airspace at
Pearson Field with Class E airspace accompanied by a special flight
rule in part 93, provided that the final rule and charting included all
procedural elements described in Safety Risk Management Document (SRMD)
SRMD-PDX-VUO-SI-2012-2991, Appendices J, K, and L and Letter to Airmen
LTA-PDX-01. Commenters asserted that these procedures, developed by the
FAA and users as part of the 2012 Safety Risk Management Panel, have
been shown to be safe and efficient for commercial and recreational
pilots at both Pearson Field and Portland International Airport.
    Commenters also argued that the proposed regulatory text has lost
the intent of the Safety Risk Management Panel by removing certain
provisions. Commenters believed that the proposed rule should include
the specific language recommended within the Safety Risk Management
Document. Commenters asserted that changes in the proposed regulatory
text negate the risk management strategies the Panel approved in the
SRMD and introduce new risk into the system in violation of the FAA's
own process. Commenters also believed the intent of the rule is to
codify and replace LTA-PDX-01. The Pearson Field Airport manager, AOPA,
and two individuals provided specific recommendations to better align
the SFRA with the current SRMD.
    The purpose of this rulemaking is not to replace or codify the
implemented mitigations discussed in SRMD-PDX-VUO-SI-2012-2991,
including the procedural recommendations and provisions in Appendices
J, K, and L. The FAA points out that initiation of a rule to establish
a special flight rules area was not discussed or recommended in SRMD-
PDX-VUO-SI-2012-2991.
    Two commenters specifically requested that SRMD-PDX-VUO-SI-2012-
2991 be referenced in the final rule, both in the preamble and the
regulatory text. This is not appropriate. The safety mitigations as
discussed in the SRMD were not regulatory and were implemented using
appropriate means. Specifically, the content of Appendix J was placed
as a special notice in the A/FD, the content of Appendix K was
published in a Letter to Airman, and the content of Appendix L is
reflected on the Seattle Sectional Aeronautical Chart. This rulemaking
did not propose to amend, eliminate, or address any of the implemented
mitigations resulting from SRMD-PDX-VUO-SI-2012-2991.
    This rulemaking codifies the communications requirement, altitude
limitation over the runway and runway centerline, and certain air
traffic control (ATC) instructions that were listed in SRMD-PDX-VUO-SI-
2012-2991 as existing controls already in place at the time of the
panel's analysis but they were only recommendations. With this
rulemaking, the FAA formalizes aspects of those existing controls.
    Best practices for compliance, including procedural
recommendations, and supplementary information are not appropriate to
codify in the regulation but are appropriate for other FAA
publications, such as the special notice placed in the A/FD. The FAA
does not find that this rule is contradictory to, or would prevent a
pilot from complying with, the procedural recommendations contained in
other FAA publications for operations at Pearson Field Airport.
    The safety mitigations currently in place are only strengthened by
this rule. Pilots must comply with the special

flight rules and should continue to comply with all recommended
procedures when operating to and from Pearson Field. This rulemaking
does not replace or amend that guidance.
    Communication requirement: An individual believed that the proposal
reduced (by omission) the inbound distance from Pearson Field that
pilots are required to establish contact with Pearson Advisory from 5
miles to approximately 1.5 miles. The commenter asserted that this will
result in increased traffic congestion over a populated area between
1,000 and 1,100 MSL in a small area northwest of Pearson Field and
south of Vancouver Lake (thus increasing traffic conflict hazards and
increasing noise over neighborhoods).
    The commenters incorrectly understood the NPRM to state that a
pilot should make his or her initial radio call when entering the
traffic pattern. Rather, the proposal was to establish a mandatory
requirement for a pilot to establish two-way radio communications with
Pearson Advisory on the common traffic advisory frequency prior to
entering the SFRA or taxiing onto the runway for departure.
Additionally, pilots would have to continuously monitor the frequency
at all times while operating within the designated airspace.
    At Pearson Field, local procedures listed in the A/FD include a
recommendation that arriving pilots contact Pearson Advisory at least 5
miles from the field to announce their position and intentions. Pilots
should comply with all recommended procedures when operating to and
from the airport; however, this rule makes it mandatory for a pilot to
establish two-way radio communications prior to entering the SFRA.
Codifying the 5 mile communication requirement would provide less
flexibility to adjust local procedures as necessary.
    Altitude limitation over the runway centerline: One individual
pointed out that the rule language only limits the operating altitude
over the runway centerline and not the over runway itself. The
commenter believed this would allow an aircraft, over the runway, to
climb to a potentially unsafe altitude. The FAA agrees with the
commenter that this could create a potentially unsafe situation.
    If a departing aircraft, or an aircraft completing a go-around,
were to start a crosswind prior to reaching the runway end, it would be
possible for that pilot to climb to an altitude greater than 700 feet
above mean sea level without having operated over the extended runway
centerline. The FAA has revised proposed Sec.  93.163(c)(1) to read:
``When operating over the runway or extended runway centerline of
Pearson Field Runway 8/26 maintain an altitude at or below 700 feet
above mean sea level.''
    Circling aircraft: One commenter believed that the new SFRA will
force incoming pilots to circle their aircraft at low altitudes for
longer periods of time which could lead to noise complaints, wasted
fuel, and contribute toward making Pearson Field less desirable. The
commenter also believed that the SFRA could lead to a decrease in use
of Pearson Field, as the rules make it harder for maintenance shops and
flight schools to use Pearson for Touch-and-Go flights which bring
money to Pearson Field. The commenter believed that this financial
issue should be weighed with the option of putting a control tower in
place.
    In making certain voluntary practices mandatory for all pilots,
unless otherwise authorized by ATC, this rule creates no more of a
deterrent to pilots than currently exists under the voluntary
procedures. Furthermore, establishment of the SFRA, along with charting
of the area, will create greater awareness of the unique operating
environment at Pearson Field and reduce the risk of a pilot operating
to or from the airport without knowledge of the local procedures.
    Existing procedures: The commenter who opposed the proposed rule
believed that the A/FD entry for Pearson already has mandatory
procedures concerning conflict avoidance, and a SFRA would be
burdensome upon general aviation pilots in the area, and would act as a
deterrent for transient pilots, who may choose another airport due to
lack of SFRA knowledge. The commenter thus believed that the SFRA would
harm the economic impact of this airport. The FAA disagrees. The
intended effect of this action is to mitigate the identified risk by
establishing requirements necessary when operating within an
established area at Pearson Field, and to increase overall system
efficiency and safety; the expected outcome will have only a minimal
impact.
    FAA guidance such as the procedures contained in the A/FD are not
mandatory and do not constitute a regulation. This guidance is
voluntary and is issued to outline methods of best practice for
compliance to the regulations.

V. Regulatory Notices and Analyses

A. Regulatory Evaluation

    Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 and Executive Order 13563 direct
that each Federal agency shall propose or adopt a regulation only upon
a reasoned determination that the benefits of the intended regulation
justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub.
L. 96-354) requires agencies to analyze the economic impact of
regulatory changes on small entities. Third, the Trade Agreements Act
(Pub. L. 96-39) prohibits agencies from setting standards that create
unnecessary obstacles to the foreign commerce of the United States. In
developing U.S. standards, the Trade Act requires agencies to consider
international standards and, where appropriate, that they be the basis
of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4) requires agencies to prepare a written assessment of
the costs, benefits, and other effects of proposed or final rules that
include a Federal mandate likely to result in the expenditure by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $100 million or more annually (adjusted for inflation with
base year of 1995). This portion of the preamble summarizes the FAA's
analysis of the economic impacts of this final rule.
    Department of Transportation Order DOT 2100.5 prescribes policies
and procedures for simplification, analysis, and review of regulations.
If the expected cost impact is so minimal that a proposed or final rule
does not warrant a full evaluation, this order permits that a statement
to that effect and the basis for it to be included in the preamble if a
full regulatory evaluation of the cost and benefits is not prepared.
Such a determination has been made for this final rule. The reasoning
for this determination follows. The FAA received no comments on the
initial regulatory evaluation minimal cost determination. The FAA makes
the same determination herein and provides the logic below.
    Due to the continued growth of Portland International Airport and
the close proximity of Pearson Field, safety issues have been
identified. To address the safety concerns between traffic operating at
Pearson Field and Portland International Airport, the FAA is
establishing a SFRA at Pearson Field in part 93. The final rule
provides a description of the area, communication requirements for both
inbound and outbound flights, and procedural requirements necessary to
reduce the risks associated with the operation.
    Currently, pilots voluntarily comply with procedures in the
airport/facility directory, to establish two-way radio

communications with Pearson Advisory, and to maintain at or below 700
feet above mean sea level when operating over the extended centerline
of Pearson Field Runway 8/26. Additionally, air traffic control
instructs pilots on Pearson advisory to obtain the Pearson Field
weather, and to remain outside Portland Class C Airspace. As a result
of being required to remain outside of Portland's Class C Airspace,
pilots must make a non-standard right traffic pattern if landing on
runway 26 at Pearson Field. A non-standard right traffic pattern is
different, required for safety, but imposes only minimal cost. The
other requirements of establishing two-way communication, obtaining the
weather report, maintaining an altitude at or below 700 feet when
operating over the runway, and remaining outside of Portland Class C
Airspace are all minimal cost. The safety concern is real. Twenty TCAS
resolution advisories (RAs) were reported and logged by air traffic
control during calendar year 2014, and 18 TCAS RAs were reported and
logged during calendar year 2015, reflecting an ongoing safety concern.
By making the voluntary compliance mandatory, the FAA expects a
decrease in the occurrence of, and will avoid an increase in, RAs. For
the reasons discussed above, the cost of the rule will be minimal.
    The FAA has, therefore, determined that this rule is not a
``significant regulatory action'' as defined in section 3(f) of
Executive Order 12866, and is not ``significant'' as defined in DOT's
Regulatory Policies and Procedures.

B. Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation. To achieve this principle, agencies are required
to solicit and consider flexible regulatory proposals and to explain
the rationale for their actions to assure that such proposals are given
serious consideration.'' The RFA covers a wide range of small entities,
including small businesses, not-for-profit organizations, and small
governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis as described in the RFA.
    However, if an agency determines that a rule is not expected to
have a significant economic impact on a substantial number of small
entities, section 605(b) of the RFA provides that the head of the
agency may so certify and a regulatory flexibility analysis is not
required. The certification must include a statement providing the
factual basis for this determination, and the reasoning should be
clear.
    The FAA believes that this final rule does not have a significant
economic impact on a substantial number of small entities for the
following reasons. For the initial regulatory flexibility analysis the
FAA explained while the rule would affect a substantial number of small
entities, the costs would be minimal. We received no comments on that
analysis. With this rule, the procedures and voluntary practices
already in place will become mandatory. The intended effect of this
action is to mitigate the identified risk by establishing requirements
necessary when operating within an established area at Pearson Field,
and to increase overall system efficiency and safety. The expected
outcome will have only a minimal economic impact on small entities
affected by this rulemaking action.
    Therefore, as provided in section 605(b), the head of the FAA
certifies that this rulemaking will not result in a significant
economic impact on a substantial number of small entities.

C. International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the
Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal
agencies from establishing standards or engaging in related activities
that create unnecessary obstacles to the foreign commerce of the United
States. Pursuant to these Acts, the establishment of standards is not
considered an unnecessary obstacle to the foreign commerce of the
United States, so long as the standard has a legitimate domestic
objective, such as the protection of safety, and does not operate in a
manner that excludes imports that meet this objective. The statute also
requires consideration of international standards and, where
appropriate, that they be the basis for U.S. standards. The FAA has
assessed the potential effect of this final rule and determined that
the rule would protect safety and is not considered an unnecessary
obstacle to foreign commerce.

D. Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(in 1995 dollars) in any one year by State, local, and tribal
governments, in the aggregate, or by the private sector; such a mandate
is deemed to be a ``significant regulatory action.'' The FAA currently
uses an inflation-adjusted value of $155 million in lieu of $100
million. This final rule does not contain such a mandate; therefore,
the requirements of Title II of the Act do not apply.

E. Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that the FAA consider the impact of paperwork and other information
collection burdens imposed on the public. The FAA has determined that
there is no new requirement for information collection associated with
this final rule.

F. International Compatibility and Cooperation

    In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to conform to ICAO
Standards and Recommended Practices to the maximum extent practicable.
The FAA has reviewed the corresponding ICAO Standards and Recommended
Practices and has identified no corresponding standards with these
regulations.

G. Environmental Analysis

    FAA Order 1050.1F identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this rulemaking action qualifies for the categorical
exclusion identified in paragraph 5-6.6f and involves no extraordinary
circumstances.

VI. Executive Order Determinations

A. Executive Order 13132, Federalism

    The FAA has analyzed this rule under the principles and criteria of
Executive Order 13132, Federalism. The agency has determined that this
action will not have a substantial direct effect on the States, or the
relationship between the Federal Government and the States, or on the
distribution of power and responsibilities among the various

levels of government, and, therefore, will not have Federalism
implications.

B. Executive Order 13211, Regulations That Significantly Affect Energy
Supply, Distribution, or Use

    The FAA analyzed this rule under Executive Order 13211, Actions
Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). The agency has determined that it
will not be a ``significant energy action'' under the executive order
and will not be likely to have a significant adverse effect on the
supply, distribution, or use of energy.

C. Executive Order 13609, Promoting International Regulatory
Cooperation

    Executive Order 13609, Promoting International Regulatory
Cooperation, (77 FR 26413, May 4, 2012) promotes international
regulatory cooperation to meet shared challenges involving health,
safety, labor, security, environmental, and other issues and to reduce,
eliminate, or prevent unnecessary differences in regulatory
requirements. The FAA has analyzed this action under the policies and
agency responsibilities of Executive Order 13609, and has determined
that this action will have no effect on international regulatory
cooperation.

VII. Additional Information

A. Availability of Rulemaking Documents

    An electronic copy of rulemaking documents may be obtained from the
Internet by--
     Searching the Federal eRulemaking Portal (http://www.regulations.gov);
     Visiting the FAA's Regulations and Policies Web page at
http://www.faa.gov/regulations_policies or
     Accessing the Government Publishing Office's Web page at
http://www.fdsys.gov.
    Copies may also be obtained by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue SW., Washington, DC 20591, or by calling<PHONE_NUMBER>.
Commenters must identify the docket, amendment, or notice number of
this rulemaking.
    All documents the FAA considered in developing this rule, including
economic analyses and technical reports, may be accessed from the
Internet through the Federal eRulemaking Portal referenced above.

B. Comments Submitted to the Docket

    Comments received may be viewed by going to http://www.regulations.gov and following the online instructions to search the
docket number for this action. Anyone is able to search the electronic
form of all comments received into any of the FAA's dockets by the name
of the individual submitting the comment (or signing the comment, if
submitted on behalf of an association, business, labor union, etc.).

C. Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act of 1996
(SBREFA) requires FAA to comply with small entity requests for
information or advice about compliance with statutes and regulations
within its jurisdiction. A small entity with questions regarding this
document may contact its local FAA official, or the person listed under
the FOR FURTHER INFORMATION CONTACT heading at the beginning of the
preamble. To find out more about SBREFA on the Internet, visit http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

List of Subjects in 14 CFR Part 93

    Air traffic control, Airports, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends chapter I of title 14, Code of Federal
Regulations as follows:

PART 93--SPECIAL AIR TRAFFIC RULES

0
1. The authority citation for part 93 is added to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40109, 40113,
44502, 44514, 44701, 44715, 44719, 46301.

0
2. Add subpart N to part 93 to read as follows:
Subpart N--Pearson Field (Vancouver, WA) Airport Traffic Rule
Sec.
93.161 Applicability.
93.162 Description of area.
93.163 Aircraft operations.

Subpart N--Pearson Field (Vancouver, WA) Airport Traffic Rule

Sec.  93.161  Applicability.

    This subpart prescribes special air traffic rules for aircraft
conducting VFR operations in the vicinity of the Pearson Field Airport
in Vancouver, Washington.

Sec.  93.162  Description of area.

    The Pearson Field Airport Special Flight Rules Area is designated
as that airspace extending upward from the surface to but not including
1,100 feet MSL in an area bounded by a line beginning at the point
where the 019[deg] bearing from Pearson Field intersects the 5-mile arc
from Portland International Airport extending southeast to a point 1\1/
2\ miles east of Pearson Field on the extended centerline of Runway 8/
26, thence south to the north shore of the Columbia River, thence west
via the north shore of the Columbia River to the 5-mile arc from
Portland International Airport, thence clockwise via the 5-mile arc to
point of beginning.

Sec.  93.163   Aircraft operations.

    (a) Unless otherwise authorized by ATC, no person may operate an
aircraft within the airspace described in Sec.  93.162, or taxi onto
the runway at Pearson Field, unless-
    (1) That person establishes two-way radio communications with
Pearson Advisory on the common traffic advisory frequency for the
purpose of receiving air traffic advisories and continues to monitor
the frequency at all times while operating within the specified
airspace.
    (2) That person has obtained the Pearson Field weather prior to
establishing two-way communications with Pearson Advisory.
    (b) Notwithstanding the provisions of paragraph (a) of this
section, if two-way radio communications failure occurs in flight, a
person may operate an aircraft within the airspace described in Sec.
93.162, and land, if weather conditions are at or above basic VFR
weather minimums. If two-way radio communications failure occurs while
in flight under IFR, the pilot must comply with Sec.  91.185.
    (c) Unless otherwise authorized by ATC, persons operating an
aircraft within the airspace described in Sec.  93.162 must--
    (1) When operating over the runway or extended runway centerline of
Pearson Field Runway 8/26 maintain an altitude at or below 700 feet
above mean sea level.
    (2) Remain outside Portland Class C Airspace.
    (3) Make a right traffic pattern when operating to/from Pearson
Field Runway 26.

    Issued in Washington, DC, under the authority of 49 U.S.C.
106(f), 40103, and 44701(a)(5) on August 26, 2016.
Michael P. Huerta,
Administrator.
[FR Doc. 2016-21377 Filed 9-9-16; 8:45 am]
BILLING CODE 4910-13-P


MPORTANT NOTE TO USER:

This OMB form has been recreated in WP6.0 by OPPTS staff. The margins and lines are NOT block protected, so you must fill the form with caution, paying attention to any shifting of the existing text. The following tips should make this a simple task:

 Fill in the spaces by using the type over command. Otherwise you'll have to delete a space for each letter you add.

 Use the same font ( Times New Roman 8pt).

 Do not change table lines ( although you can delete an extra space line to provide more space elsewhere.

 It is not recommended that you convert this form to WP5.1, some of these features are not available in WP5.1, so the text will scramble.

If you have any problems or questions, please call your RID Desk Officer @ 260 2706. PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request United States Environmental Protection Agency, Region IX 2. OMB control number b. X None a__ __ __ __  __ __ __ __ 2009_

3. Type of information collection ( check one) a. X New collection b. G Revision of a currently approved collection c. G Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title: 2001 Emergency Planning and Community Right to Know Act ( EPCRA) and Risk Management Program ( RMP) Implementation Status Questionnaire For Tribal Emergency Response Commissions ( TERCs) and Their Duly Appointed Local Emergency Planning Committee( s) ( LEPCs).

8. Agency form number( s) ( If applicable) 2004.01 9. Keywords Environmental Protection, Emergency Planning, Risk Management 10. Abstract: To determine and improve the level of the United States Environmental Protection Agency, Region IX's support to the Region's Federally recognized Indian tribes and their Tribal Emergency Response Commissions ( TERCs) and their duly appointed Local Emergency Response Planning Committees, Region IX has designed a questionnaire and proposes to conduct a Region wide voluntary survey of tribal emergency response organizations. Essentially, the information collected will be used to assess the progress, status, needs, resources and activity level of the TERCs. The information will be used by EPA Region IX staff to gain a better understanding of the tribes' actual implementation of EPCRA and RMP.

11. Affected public ( Mark primary with " P" and all others that apply with " X")

a. Individuals or households d. Farms b. Business or other for profit e. Federal Government c. Not for profit institutions f. P State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. X Voluntary b. G Required to obtain or retain benefits c. G Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 145 b. Total annual responses 145 1. Percentage of these responses collected electronically 20% % c. Total hours requested 290 d. Current OMB inventory  0 e. Difference 290 f. Explanation of difference 1. Program Change 290 2. Adjustment  0 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs  0 b. Total annual costs ( O& M)  0 c. Total annualized cost requested  0 d. Current OMB inventory  0 e. Difference  0 f. Explanation of difference 1. Program change  0 2. Adjustment  0

15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. _ X_ Program planning or management b. P_ Program evaluation f. __ Research c. __ General purpose statistics g. __ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. Q Recordkeeping b. Q Third party disclosure c. Q Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. X Q Other ( describe) Once 17. Statistical methods Does this information collection employ statistical methods?

Q Yes XQ No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Sam Agpawa, EPA Region IX, EPCRA/ CEPP Team Phone: 415 744 2342 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Michael Feeley, Deputy Director, Superfund Division U. S. Environmental Protection Agency, Region IX Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95


50138 Federal Register / Vol. 68, No. 161 / Wednesday, August 20, 2003 / Notices ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0262; FRL   7321   7]

Dimethomorph; Notice of Filing Pesticide Petitions to Establish Tolerances for Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the initial filing of pesticide petitions proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP   2003   0262, must be received on or before September 19, 2003.

ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   3194; e mail address: brothers. shaja@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

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

1. Docket. EPA has established an official public docket for this action under docket ID number OPP   2003   0262. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also, include this contact information on the outside of any disk VerDate jul< 14> 2003 16: 06 Aug 19, 2003 Jkt 200001 PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 20AUN1. SGM 20AUN1 50139 Federal Register / Vol. 68, No. 161 / Wednesday, August 20, 2003 / Notices or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP   2003   0262. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: Docket ID number OPP   2003   0262. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001, Attention: Docket ID number OPP   2003   0262. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID number OPP   2003   0262. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking? EPA has received pesticide petitions proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: August 11, 2003. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions The petitioner's summary of the pesticide petitions are printed below as required by FFDCA section 408( d)( 3). The summary of the petitions were prepared by BASF Corporation and represents the view of BASF Corporation. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

Interregional Research Project Number 4 ( IR 4)

PP 2E6483 and PP 3E6558 EPA has received pesticide petitions ( 2E6483 and 3E6558) from Interregional Research Project Number 4 ( IR 4), 681 U. S. Highway # 1 South, North Brunswick, NJ 08902   3390 proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180.493 by establishing tolerances for residues of dimethomorph, ( E, Z) 4[ 3( 4 chlorophenyl) 3( 3,4 dimethoxyphenyl) 1 oxo 2 propenyl morpholine in or on the following raw agricultural commodities: Vegetable, fruiting, group 8 at 2.0 parts per million ( ppm) ( 2E6483), brassica, leafy, greens,

VerDate jul< 14> 2003 16: 06 Aug 19, 2003 Jkt 200001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 20AUN1. SGM 20AUN1 50140 Federal Register / Vol. 68, No. 161 / Wednesday, August 20, 2003 / Notices ( subgroup 5B), and turnip, tops at 20 ppm ( PP 3E6558), taro, leaves at 6.0 ppm ( 3E6558), and taro, roots at 0.5 ppm ( 3E6558). IR 4 also proposes to delete the existing tolerance for tomato, fruit at 0.5 ppm. Tomato is included in the proposed tolerance for the fruiting vegetable group 8 at 2.0 ppm. EPA has determined that the petitions contain data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petitions. Additional data may be needed before EPA rules on the petitions. This summary has been prepared by BASF Corporation, Research Triangle Park, NC 27709.

A. Residue Chemistry 1. Plant metabolism. Based upon the results of metabolism studies conducted on potato, grape, and lettuce, the nature of the residues in plants is considered to be understood. 2. Analytical method. A reliable method for the determination of dimethomorph residues in fruiting vegetables ( except cucurbits) ( crop group 8), leafy brassica greens ( subgroup 5B), turnip greens, taro leaves and roots exists; this method is the FDA Multi Residue Method, Protocol D, as published in the Pesticide Analytical Manual I. 3. Magnitude of residues. The magnitude of residues for the proposed tolerances are adequately understood.

B. Toxicological Profile 1. Acute toxicity   i. Oral lethal dose LD50 studies were conducted on dimethomorph technical: a. An acute oral toxicity study in the Sprague Dawley rat for dimethomorph technical with a LD50 of 4,300 milligrams/ kilogram body weight ( mg/ kg bwt) for males and 3,500 mg/ kg bwt for females. Based upon EPA toxicity criteria, the acute oral toxicity category for dimethomorph technical is Category III or slightly toxic. b. An acute toxicity study in the CD 1 mouse for dimethomorph technical with a LD50 of greater than 5,000 mg/ kg bwt for males and 3,699 mg/ kg/ bwt for females. Based on the EPA toxicity category criteria, the acute oral toxicity category for dimethomorph technical is Category III or slightly toxic. ii. Oral LD50 studies were conducted on the two isomers ( E and Z) alone: a. An acute oral toxicity study in the Wistar rat for the E isomer with a LD50 greater than 5,000 mg/ kg bwt for males and approximately 5,000 mg/ kg bwt for females. b. An acute oral toxicity study in the Wistar rat for the Z isomer with a LD50 greater than 5,000 mg/ kg bwt for both males and females. iii. An acute dermal toxicity study in the Wistar rat for dimethomorph technical with a dermal LD50 greater than 5,000 mg/ kg bwt for both males and females. Based on the EPA toxicity category criteria, the acute dermal toxicity category for dimethomorph is Category IV or relatively non toxic. iv. A 4   hour inhalation study in Wistar rats for dimethomorph technical with a lethal concentration LC50 greater than 4.2 milligram per liter ( mg/ L) for both males and females. Based on the EPA toxicity category criteria, the acute inhalation toxicity category for dimethomorph technical is Category IV or relatively non toxic. v. A skin irritation study was performed using New Zealand White rabbits. Based on EPA's toxicity criteria, the skin irritation toxicity category for dimethomorph technical in this study is Category IV or non to slightly irritating. vi. An eye irritation study using New Zealand white rabbits demonstrated dimethomorph technical produced moderate conjunctival redness, slight to moderate chemosis and slight discharge 3 hours after treatment. Based on EPA's toxicity criteria, the eye toxicity category for dimethomorph technical is Category III ( slightly to moderately irritating). 2. Genotoxicity.   i. Salmonella reverse gene mutation assays ( 2 studies) were negative up to a limit dose of 5,000 g/ plate. Chinese hamster lung V79 cells were negative for mutations at the HGPRT locus at up to toxic doses in two studies. ii. Two Chinese hamster lung ( V79 cells) structural chromosomal studies were reportedly positive for chromosomal aberrations at the highest dose tested ( HDT) ( 160 g/ ml/ S9; 170 g/ ml/+ S9). However, dimethomorph induced only a weak response in increasing chromosome aberrations in this test system. In addition, these results were not confirmed in two micronucleus tests under in vivo conditions. iii. Structural chromosomal aberration studies were weakly positive in human lymphocytic cultures, but only in S9 activated cultures treated at 422 g/ mL, the HDT, which was strongly cytotoxic. No increase in chromosomal aberrations was observed in the absence of S9 activation at all doses. Furthermore, the positive clastogenic response observed under the in vitro conditions was not confirmed in two in vivo micronucleus assays. iv. Micronucleus assay ( 2 studies) indicated that dimethomorph was negative for inducing micronuclei in bone marrow cells of mice following i. p. administration of doses up to 200 mg/ kg or oral doses up to the limit dose of 5,000 mg/ kg. Thus, dimethomorph was found to be negative in these studies for causing cytogenic damage in vivo. v. Dimethomorph was negative for inducing unscheduled DNA synthesis, in cultured rat liver cells, at doses up to 250 grams per milliliter ( g/ ml), a weakly cytotoxic level. vi. Dimethomorph was negative for transformation in Syrian hamster embryo cells treated, in the presence and absence of activation, up to cytotoxic concentrations ( 265 g/ mL/+ S9; 50 g/ mL/ S9). 3. Reproductive and developmental toxicity   i. A rat developmental toxicity study with a lowest observed adverse effect level ( LOAEL) for maternal toxicity of 160 mg/ kg/ day and a NOAEL for maternal toxicity of 60 mg/ kg/ day. The NOAEL for developmental toxicity is 60 mg/ kg/ day. Dimethomorph is not teratogenic in the Sprague Dawley rat. ii. A rabbit development toxicity study with a LOAEL for maternal toxicity of 650 mg/ kg/ day and a NOAEL for maternal toxicity of 300 mg/ kg/ day. The NOAEL for developmental toxicity is 650 mg/ kg/ day, the HDT. Dimethomorph is not teratogenic in the New Zealand white rabbit. iii. A two generation rat reproduction study with a LOAEL for parental systemic toxicity of 1,000 ppm, or approximately 80 mg/ kg/ day, and a NOAEL for parental systemic toxicity of 300 ppm, or approximately 24 mg/ kg/ day. The NOAEL for fertility and reproductive function was 1,000 ppm, the highest concentration tested ( HCT), or approximately 80 mg/ kg bwt/ day. 4. Subchronic toxicity   i. A 90   day dietary study in Sprague Dawley rats with a NOAEL of greater than or equal to 1,000 ppm, the HCT tested, or approximately 73 mg/ kg/ day for males and 82 mg/ kg/ day for females. ii. A 90   day dog dietary study with a NOAEL of 450 ppm, or approximately 15 mg/ kg/ day, and a LOAEL of 1,350 ppm, or approximately 43 mg/ kg/ day. 5. Chronic toxicity   i. A 2   year chronic toxicity study in Sprague Dawley rats with a NOAEL of 200 ppm or approximately 9 mg/ kg/ day for males and 12 mg/ kg/ day for females. The LOAEL for systemic toxicity is 750 ppm, or approximately 36 mg/ kg/ day for males and 58 mg/ kg/ day for females. ii. A 1   year chronic toxicity study in dogs with a NOAEL of 450 ppm, or approximately 14.7 mg/ kg/ day and a VerDate jul< 14> 2003 16: 06 Aug 19, 2003 Jkt 200001 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 20AUN1. SGM 20AUN1 50141 Federal Register / Vol. 68, No. 161 / Wednesday, August 20, 2003 / Notices LOAEL of 1,350, or approximately 44.6 mg/ kg/ day. iii. A 2   year oncogenicity study in Sprague Dawley rats with a NOAEL for systemic toxicity of 200 ppm, or approximately 9 mg/ kg/ day for males and 11 mg/ kg/ day for females. The LOAEL for systemic toxicity was 750 ppm, or approximately 34 mg/ kg/ day for males and 46 mg/ kg/ day for females. There was no evidence of increased incidence of neoplastic lesions in treated animals. The NOAEL for oncogenicity is 2,000 ppm, the Highest Concentration Tested ( HCT), or approximately 95 mg/ kg/ day for males and 132 mg/ kg/ day for females. iv. A 2   year oncogenicity study in CD 1 mice with a NOAEL for systemic toxicity of 100 mg/ kg/ day and a LOAEL of 1,000 mg/ kg/ day. There was no evidence of increased incidence of neoplastic lesions in treated animals. The NOAEL for oncogenicity is 1,000 mg/ kg/ day, the HDT. 6. Animal metabolism. Results from the livestock and rat metabolism studies show that orally administered dimethomorph was rapidly excreted by the animals. The principal route of elimination is the feces. 7. Metabolite toxicology. There were no metabolites identified in plant or animal commodities which require regulation. 8. Endocrine disruption. Collective organ weights and histopathological findings from the two generation reproduction study in rats, as well as from the subchronic and chronic toxicity studies in two or more animal species, demonstrate no apparent estrogenic effects or effects on the endocrine system. There is no information available which suggests that dimethomorph technical would be associated with endocrine effects.

C. Aggregate Exposure 1. Dietary exposure. The CARES 1.1 model with the CSFII/ FCID consumption data were used to calculate chronic and acute exposure estimates. Result exposure estimates 99.9th percentile were compared against the dimethomorph reference dose ( RfD) and chronic population adjusted dose ( cPAD). i. Food. The dietary assessment analysis followed an initial tier approach with only one minor refinement. Tolerance values, default processing factors, and 100% crop treated ( CT) values were assumed in the assessment. The only minor refinement was including percent crop treated values for potatoes ( 2.2%), tomatoes ( 0.1%), cucumbers ( 2.9%), and pumpkin ( 13.6%). Vegetables ( fruiting, bulb, cucurbit), lettuce ( leaf, head), grapes ( including raisins), potatoes, hops, grain, brassica ( leafy greens), leaves of root and tuber vegetables, and taro roots as the target crops were also considered for this analysis. a. Chronic. Results of the chronic dietary exposure assessment for dimethomorph ( BAS 550 F) are listed in Table 1. The estimated chronic dietary exposure for all current and pending commodities ranged from 7.5% to 15.2% of the % cPAD ( 0.1 mg/ kg bwt/ day) for all subpopulations.

TABLE 1.   CHRONIC DIETARY EXPOSURE ASSESSMENT FOR DIMETHOMORPH ( BAS 550 F)

Population Exposure Estimate ( mg/ kg bwt/ day) % cRfD % cPAD Birth to 1   year 0.007972 7.97 7.97 1   2 years 0.01513 15.13 15.13 3   5 years 0.01331 13.31 13.31 1   6 years 0.01512 15.12 15.12 6   12 years 0.007794 7.79 7.79 Teens 13   19 years 0.007482 7.48 7.48 Females 13   49 years 0.007771 7.77 7.77 Males 20   49 years 0.006853 6.85 6.85 Adults 50+ years 0.007548 7.55 7.55 b. Acute. Exposure estimates for the dimethomorph acute dietary assessment ranged from 0.064 to 0.174 mg/ kg bwt/ day for all subpopulations ( Table 2). The % aRfd and % aPAD were not applicable for the acute dietary assessment since toxicology studies have shown that dimethomorph poses no acute dietary risk.

TABLE 2.   ACUTE DIETARY EXPOSURE ASSESSMENT FOR DIMETHOMORPH ( BAS 550 F)

Population Exposure Estimate ( mg/ kg bwt/ day) % aRfD % aPAD Birth to 1   year 0.1736 NA NA 1   2 years 0.1742 NA NA 3   5 years 0.1584 NA NA 1   6 years 0.1654 NA NA 6   12 years 0.09621 NA NA VerDate jul< 14> 2003 16: 06 Aug 19, 2003 Jkt 200001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 20AUN1. SGM 20AUN1 50142 Federal Register / Vol. 68, No. 161 / Wednesday, August 20, 2003 / Notices TABLE 2.   ACUTE DIETARY EXPOSURE ASSESSMENT FOR DIMETHOMORPH ( BAS 550 F)   Continued Population Exposure Estimate ( mg/ kg bwt/ day) % aRfD % aPAD Teens 13   19 years 0.07855 NA NA Females 13   49 years 0.07306 NA NA Males 20   49 years 0.06386 NA NA Adults 50 + years 0.07058 NA NA Results of the chronic and acute dietary exposure analysis demonstrate a reasonable certainty that no harm to the general U. S. population or any subpopulation would results from the use of dimethomorph on vegetables ( fruiting, bulb, cucurbit), lettuce ( leaf, head), grapes ( including raisins), potatoes, hops, grain, brassica ( leafy greens), leaves of root and tuber vegetables, and taro root. ii. Drinking water. EPA's Pesticide Root Zone Model/ Exposed Analysis Modeling System ( PRZM/ EXAMS) and Screening Concentration in Groundwater ( SCI GROW) models were used to estimate the maximum dimethomorph concentrations in surface water and ground water, respectively. Results for the chronic drinking water assessment are listed in Table 3.

TABLE 3.   CHRONIC DRINKING WATER ASSESSMENT FOR DIMETHOMORPH DWLOC chronic Adult males 20   49 Adult females 13   49 Children 1   6 years Children birth to 1 No effect level 9 9 9 9 Safety factor 100 100 100 100 RfD= 0.09 0.09 0.09 0.09 cPAD 0.09 0.09 0.09 0.09 A) Chronic food ( mg/ kg/ day) 0.006853 0.007771 0.01512 0.007972 B) Residential ( mg/ kg/ day) 0 0 0 0 water cPAD( A+ B) 0.08314700 0.10222900 0.07488000 0.08202800 DWLOC chronic µ g/ L 2910 3067 749 820 DEC's PRZM/ EXAMS ( EFED) surface water ( µ g/ L) 12.65 12.65 12.65 12.65 Sci Grow ( EFED) ground water 0.26 0.26 0.26 0.26 2. Aggregate exposure ( diet + water). The aggregate exposure of dimethomorph residues for food and drinking water is summarized in Table 4 below. Currently dimethomorph ( BAS 550 F) is not considered for residential use and therefore residential exposure was not included in the aggregate exposure assessment.

TABLE 4.   AGGREGATE EXPOSURE OF DIMETHOMORPH ( BAS 550 F)

Exposure Infants ( 0   1 years) Children ( 1   6 years) Males ( 20   49 years) Females ( 13   49 years)

FOOD Acute exposure ( mg/ kg bwt/ day) 0.1736 0.1654 0.06386 0.07306 Chronic exposure ( mg/ kg bwt/ day) 0.007972 0.01512 0.006853 0.007771 % aRfD and % aPAD NA NA NA NA % cRfD and % cPAD 7.97 15.12 6.85 7.77 WATER Acute exposure ( mg/ kg/ bwt) 0.001265 0.000843 0.000361 0.000402 VerDate jul< 14> 2003 16: 06 Aug 19, 2003 Jkt 200001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 20AUN1. SGM 20AUN1 50143 Federal Register / Vol. 68, No. 161 / Wednesday, August 20, 2003 / Notices TABLE 4.   AGGREGATE EXPOSURE OF DIMETHOMORPH ( BAS 550 F)   Continued Exposure Infants ( 0   1 years) Children ( 1   6 years) Males ( 20   49 years) Females ( 13   49 years)

Chronic exposure ( mg/ kg bwt/ day) 0.001265 0.000843 0.000361 0.000402 % aRfD and % aPAD NA NA NA NA % cRfD and % cPAD 25.30 16.87 7.23 8.03 AGGREGATE Acute exposure ( mg/ kg bwt/ day) 0.174865 0.166243 0.064221 0.073462 Chronic exposure ( mg/ kg bwt/ day) 0.009237 0.015963 0.007214 0.008173 % aRfD and % aPAD NA NA NA NA % cRfD and % cPAD 33.27 31.99 14.08 15.80 These results indicate the aggregate exposure of dimethomorph ( BAS 550 F), from potential residues in food and drinking water, will not exceed EPA's level of concern ( 100% of RfD). Overall, considering a `` worst case'' scenario, we can conclude with reasonable certainty that no harm will occur from either acute or chronic aggregate exposure of dimethomorph residues in the current and pending commodities. 3. Non dietary exposure. Currently, there are no registered residential uses for dimethomorph in the United States. Thus, an assessment of non dietary exposure is not relevant to this petition.

D. Cumulative Effects There is no information to indicate that any toxic effects produced by dimethomorph would be cumulative with those of any other chemical. The fungicidal mode of action of dimethomorph is unique; dimethomorph inhibits cell wall formation only in Oomycete fungi. The result is lysis of the cell wall that kills growing cells and inhibits spore formation in mature hyphae. This unique mode of action and limited pest spectrum suggest that there is little or no potential for cumulative toxic effects in mammals. In addition, the toxicity studies submitted to support this petition do not indicate that dimethomorph is a particularly toxic compound. No toxic end points of potential concern were identified.

E. Safety Determination 1. U. S. population. Based on the acute toxicity data, BASF believes that dimethomorph does not pose any acute dietary risks. Therefore, a calculation of an acute RfD is not needed. The cPAD is 0.1 mg/ kg bwt/ day, based on a NOAEL of approximately 10 mg/ kg bwt/ day ( 200 ppm) from a 2   year dietary toxicity study in rats that demonstrated decreased body weight and liver foci in females at 750 ppm. The cPAD is calculated using an uncertainty factor of 100. The theoretical maximum residue concentration ( TMRC) for all commodities covered in this petition is estimated at 0.003 mg/ kg bwt/ day for the general population. This represents a dietary exposure to the general population of the United States that is 3.0% of the cPAD. The combined TMRC for all current and pending dimethomorph tolerances in potatoes, tomatoes, grapes, hops, cereal grain commodities, lettuce ( head and leaf), endive ( escarole), radichio, cucurbit vegetables ( crop group 9), bulb vegetables ( crop group 3), and fruiting vegetables ( except cucurbits) ( crop group 8) will utilize less than 10% of the cPAD for the general U. S. population. Since EPA generally has no concern for exposures below 100 percent of the cPAD, EPA should conclude that there is a reasonable certainty that no harm will result from aggregate exposure to dimethomorph residues in or on commodities of the cited crops. 2. Infants and children. The TMRC for all commodities covered in this petition is minimal. The consumption of residues of dimethomorph on commodities associated with this request will use approximately 7.0% of the cPAD for children ages 1   6. Moreover, the combined TMRC values for all current and pending dimethomorph tolerances will utilize less than 10% of the cPAD for each of the subgroups. The results of the studies submitted to support this package provide no evidence that dimethomorph caused reproductive, developmental or fetotoxic effects. No such effects were noted at dose levels that were not maternally toxic. The NOAELs observed in the developmental and reproductive studies were 6 to 65 times higher than the NOAEL used to establish the cPAD. There is no evidence to indicate that children or infants would be more sensitive than adults to toxic effects caused by exposure to dimethomorph. Therefore, the registrant believes that the results of the toxicology and metabolism studies support both the safety of dimethomorph to humans based on the intended use as a fungicide on domestically produced fruiting vegetables ( except cucurbits) ( crop group 8) and the granting of the requested tolerances.

F. International Tolerances.

There are no Canadian, Mexican, or Codex maximum residue levels established for dimethomorph for the commodities associated with this request; consequently, a discussion of international harmonization is not relevant. [ FR Doc. 03   20899 Filed 8   19   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0222; FRL   7316   3]

Issuance of Experimental Use Permits AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMMARY: EPA has granted experimental use permits ( EUP) to the following pesticide applicants. An EUP permits use of a pesticide for experimental or research purposes only in accordance with the limitations in the permit.

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[Federal Register: February 6, 2009 (Volume 74, Number 24)]
[Notices]
[Page 6332-6333]
[DOCID:fr06fe09-90]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59336; File No. SR-CBOE-2008-127]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Order Approving Proposal To Eliminate the $3 Underlying
Price Requirement for Continued Listing and Listing of Additional
Series

February 2, 2009.
    On December 18, 2008, the Chicago Board Options Exchange,
Incorporated (``Exchange'' or ``CBOE'') filed with the Securities and
Exchange Commission (``Commission'') pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to eliminate the $3 underlying
price requirement for continued listing and for the listing of
additional series. The proposed rule change was published for comment
in the Federal Register on January 2, 2009.\3\ The Commission received
one comment letter on the proposed rule change.\4\ This order approves
the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(l).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 59152 (December 23,
2008), 74 FR 149 (January 2, 2009) (``Notice'').
    \4\ See letter to Florence E. Harmon, Acting Secretary,
Commission, from Janet M. Kissane, Senior Vice President--Legal and
Corporate Secretary, Office of the General Counsel, NYSE Euronext
dated January 9, 2009 (``NYSE Euronext Letter'').
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    The proposed rule change amends CBOE Rule 5.4.01 to eliminate the
$3 market price per share requirement from the Exchange's requirements
for continued approval for an underlying security and amends CBOE Rule
5.4.02 to eliminate the prohibition against listing additional series
of options on an underlying security at any time when the price per
share of such underlying security is less than $3.
    The Exchange believes that the $3 market price per share
requirement is no longer necessary or appropriate, and states that only
those underlying securities meeting the remaining maintenance listing
criteria set forth in Rule 5.4.01 will be eligible for

continued listing and the listing of additional option series. The
Exchange believes that the current $3 market price per share
requirement could have a negative effect on investors. For example, in
the current volatile market environment, the Exchange is currently
unable to list new series on underlying securities trading below $3. If
there is market demand for series below $3, the Exchange would be
unable to accommodate such requests and investors would be unable to
hedge their positions with options series with strikes below $3.
    After carefully reviewing the proposed rule change, the Commission
finds that the proposal is consistent with the requirements of the Act
and the rules and regulations thereunder applicable to a national
securities exchange.\5\ In particular, the Commission finds that the
proposed rule change is consistent with Section 6(b)(5) of the Act,\6\
which, among other things, requires that the rules of a national
securities exchange be designed to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in regulating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest.
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    \5\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \6\ 15 U.S.C. 78f(b)(5).
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    CBOE's rules provide that a security underlying an option will not
be deemed to meet the requirements for continued approval if the
underlying security ceases to be an NMS stock.\7\ CBOE's rules also
include other minimum standards for continued approval, including
requirements related to the minimum number of outstanding shares,
number of holders, and trading volume of the underlying security.\8\
The Commission believes that securities underlying options traded on
CBOE will remain subject to adequate minimum standards for continued
approval, which should help to ensure that only options on liquid
underlying securities are permitted to trade on CBOE. The Commission
also notes that the NYSE Euronext letter generally supports the
proposal.\9\ Accordingly, the Commission believes that CBOE's proposed
rule change is consistent with the Act.
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    \7\ See CBOE Rule 5.4.01(f). Rule 600 of Regulation NMS defines
an NMS security as ``any security or class of securities for which
transaction reports are collected, processed, and made available
pursuant to an effective transaction reporting plan, or an effective
national market system plan for reporting transactions in listed
options,'' and an NMS stock as ``any NMS security other than an
option.''
    \8\ See CBOE Rule 5.4.01(a)-(c).
    \9\ See NYSE Euronext Letter, supra note 4.
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    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\10\ that the proposed rule change (SR-CBOE-2008-127), be, and
hereby is, approved.
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    \10\ 15 U.S.C. 78s(b)(2).
    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-2481 Filed 2-5-09; 8:45 am]

BILLING CODE 8011-01-P