[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Page 41256]
[FR Doc No: 2017-18368]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-485-000]

Tallgrass Interstate Gas Transmission, LLC; Notice of Application

    Take notice that on August 18, 2017, Tallgrass Interstate Gas
Transmission, LLC (Tallgrass), 370 Van Gordon Street, Lakewood,
Colorado 80228, filed an application pursuant to section 7(b) of the
Natural Gas Act (NGA) and Part 157 of the Commission's Regulations
requesting authority to abandon a 47-mile 16-inch-diameter pipe segment
(Segment 55) on its pipeline system from the discharge side of the
existing Labonte Compressor Station located in Converse County, Wyoming
to the inlet side of the existing Guernsey Compressor Station located
in Platte County, Wyoming. Tallgrass states that Segment 55 will be
abandoned in place and sold to Tallgrass Midstream, LLC (TMID), an
affiliate. Upon authorization to abandon the facilities described
above, TMID will purchase, convert, own and operate the pipeline
segment as a crude oil pipeline to meet the increasing demand for
pipeline transportation of crude oil. The filing may be viewed on the
web at http://www.ferc.gov using the ``eLibrary'' link. Enter the
docket number excluding the last three digits in the docket number
field to access the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Any questions concerning this application should be directed to
David Haag, Vice President, Regulatory, Tallgrass Interstate Gas
Transmission, LLC, 370 Van Gordon Street Lakewood, CO 80228-1519,
phone:<PHONE_NUMBER> or email<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9),
within 90 days of this Notice, the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule will serve to
notify federal and state agencies of the timing for the completion of
all necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 5 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically should
submit an original and 5 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on September 14, 2017.

    Dated: August 24, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-18368 Filed 8-29-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Rules and Regulations]
[Pages 39532-39533]
[FR Doc No: 2017-17508]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0109; Airspace Docket No. 16-ASO-13]

Amendment of VOR Federal Airways V-7 and V-67; TN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action modifies VOR Federal airways V-7 and V-67, in the
eastern United States due to the planned decommissioning of the Graham,
TN, VORTAC navigation aid.

DATES: Effective date 0901, October 12, 2017. The Director of the
Federal Register approves this incorporation by reference action under
Title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

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

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it modifies the air traffic service route structure in the
eastern United States to maintain the efficient flow of air traffic.

History

    On March 6, 2017, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend V-7 and V-67, in the
eastern United States due to the planned decommissioning of the Graham,
TN, VORTAC navigation aid (82 FR 12522), Docket No. FAA-2017-0109.
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal. Three comments
were received.

Discussion of Comments

    The Aircraft Owners and Pilots Association (AOPA) wrote that, for
those VOR NAVAIDs that are to be decommissioned and for those airways
that are correspondingly removed, the FAA should create an RNAV
waypoint at the previous NAVAID location and retain all fixes and
intersections along that route by amending their definition to that of
an RNAV waypoint. The impacted air traffic control facilities conducted
a thorough review of their operations in the areas affected by the
route changes to determine which fixes and intersections along the
route segments being removed were necessary for continuing to support
the facilities' operations and for navigation purposes through the
area. As a result, the VALER fix is the only fix being retained to
supplement the existing adjacent fixes, waypoints, and navigation aids
in the areas that the V-7 and V-67 route segments are being removed.
Additionally, the Graham VORTAC is currently functioning as a Distance
Measuring Equipment (DME) only facility and is planned to be retained
and charted as a DME facility with the ``GHM'' three-letter identifier.
The change will be reflected in all appropriate publications and
procedures prior to decommissioning the Graham VORTAC. Consequently,
the FAA does not plan to replace the Graham VORTAC or fixes along the
removed route segments with RNAV waypoints.
    One commenter noted that V-124, which is also linked to the Graham
VORTAC, is not addressed in this action. V-124 is being amended through
a separate action for the decommissioning of the Jacks Creek, TN, VOR/
DME. On June 7, 2017, the Jacks Creek final rule was published in the
Federal Register (82 FR 26336), Docket No. 16-ASO-12. That rule amends
V-124 by eliminating the route segments from Gilmore, AR, through Jacks
Creek, TN, to Graham, TN. The effective date of the V-124 change is
August 17, 2017.
    A third comment noted concern about the length of the gaps in the
amended airways V-7 and V-67. However, as the commenter admitted, this
is a non-issue since 14 CFR 91.205(d)(2) requires that aircraft
conducting IFR flight be equipped with navigation equipment suitable
for the route to be flown. Additionally, the commenter called the route
changes an important step toward implementation of the NextGen program.
    Domestic VOR Federal airways are published in paragraph 6010(a) of
FAA Order 7400.11A dated August 3, 2016, and effective September 15,
2016, which is incorporated by reference in 14 CFR 71.1. The VOR
Federal airways listed in this document will be subsequently published
in the Order.

Availability and Summary of Documents for Incorporation by Reference

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

The Rule

    This action amends Title 14, Code of Federal Regulations (14 CFR)
part 71 by modifying the descriptions of VOR Federal airways V-7, and
V-67, due to the planned decommissioning of the Graham, TN, VORTAC. The
route changes are described below.
    V-7: V-7 extends between Dolphin, FL, and Sawyer, MI. This rule
removes the Graham, TN, VORTAC from the route which creates a gap in
the route

between Muscle Shoals, AL, and Central City, KY. Therefore, the amended
route extends between Dolphin, FL, and Muscle Shoals, AL, as currently
described; then between Central City, KY, and Sawyer, MI, as currently
described.
    V-67: V-67 extends between the Choo Choo, TN, VORTAC and the
Rochester, MN, VOR/DME. This rule removes the Graham, TN, VORTAC from
the route which creates a gap in the route between Shelbyville, TN, and
Cunningham, KY. Therefore, the amended route extends between Choo Choo,
TN, and Shelbyville, TN, as currently described; then between
Cunningham, KY, and Rochester, MN, as currently described. This action
also corrects the state location for the Choo Choo VORTAC to reflect
Tennessee.

Regulatory Notices and Analyses

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

Environmental Review

    The FAA has determined that this action of modifying the
descriptions of VOR Federal airways V-7, and V-67, due to the planned
decommissioning of the Graham, TN, VORTAC. qualifies for categorical
exclusion under the National Environmental Policy Act and its agency-
specific implementing regulations in FAA Order 1050.1F, ``Environmental
Impacts: Policies and Procedures'' regarding categorical exclusions for
procedural actions at paragraph 5-6.5a, which categorically excludes
from full environmental impact review rulemaking actions that designate
or modify classes of airspace areas, airways, routes, and reporting
points. Therefore, this airspace action is not expected to result in
any significant environmental impacts. In accordance with FAA Order
1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, this
action has been reviewed for factors and circumstances in which a
normally categorically excluded action may have a significant
environmental impact requiring further analysis, and it is determined
that no extraordinary circumstances exist that warrant preparation of
an environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

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

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

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

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

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016 and
effective September 15, 2016, is amended as follows:

Paragraph 6010(a)--Domestic VOR Federal Airways

* * * * *

V-7 [Amended]

    From Dolphin, FL; INT Dolphin 299[deg] and Lee County, FL,
120[deg] radials; Lee County; Lakeland, FL; Cross City, FL;
Seminole, FL; Wiregrass, AL; INT Wiregrass 333[deg] and Montgomery,
AL, 129[deg] radials; Montgomery; Vulcan, AL; to Muscle Shoals, AL.
From Central City, KY; Pocket City, IN; INT Pocket City 016[deg] and
Terre Haute, IN, 191[deg] radials; Terre Haute; Boiler, IN; Chicago
Heights, IL; INT Chicago Heights 358[deg] and Falls, WI, 170[deg]
radials; Falls; Green Bay, WI; Menominee, MI; to Sawyer, MI. The
airspace below 2,000 feet MSL outside the United States is excluded.
The portion outside the United States has no upper limit.

V-67 [Amended]

    From Choo Choo, TN; to Shelbyville, TN. From Cunningham, KY;
Marion, IL; Centralia, IL; INT Centralia 010[deg] and Vandalia, IL,
162[deg] radials; Vandalia; Spinner, IL; Burlington, IA; Iowa City,
IA; Cedar Rapids, IA; Waterloo, IA; to Rochester, MN.
* * * * *

    Issued in Washington, DC, on August 14, 2017.
Rodger A. Dean, Jr.,
Manager, Airspace Policy Group.
[FR Doc. 2017-17508 Filed 8-18-17; 8:45 am]
 BILLING CODE 4910-13-P


  MacroButton macIb01 i

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Heather Garvie, PM Team 24, (703)
308-0034

Syngenta Crop Protection, LLC, PO Box 18300, Greensboro, NC 27419

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from
Syngenta Crop Protection, LLC, PO Box 18300, Greensboro, NC 27419
requesting, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by
establishing a tolerance for residues of Sedaxane in or on the raw
agricultural commodities Grain, cereal, forage, fodder and straw, group
16 at 0.06 parts per million (ppm); Grain, cereal, group 15 at 0.01
parts per million (ppm); Peanut at 0.01 parts per million (ppm); and
Peanut, hay at 0.08 parts per million (ppm). Concurrently, Syngenta Crop
Protection, LLC requests to amend 40 CFR part 180.665 by removing
tolerances in or on Barley, grain at 0.01 ppm; Barley, hay at 0.04 ppm;
Barley, straw at 0.01 ppm; Corn, field, forage at 0.01 ppm; Corn, field,
grain at 0.01 ppm; Corn, field, stover at 0.01 ppm; Corn, pop, grain at
0.01 ppm; Corn, pop, stover at 0.01 ppm; Corn, sweet, forage at 0.01
ppm; Corn, sweet, kernel plus cob with husks removed at 0.01 ppm; Corn,
sweet, stover at 0.01 ppm; Oat, forage at 0.015 ppm; Oat, grain at 0.01
ppm; Oat, hay at 0.06 ppm; Oat, straw at 0.01 ppm; Rye, forage at 0.015
ppm; Rye, grain at 0.01 ppm; Rye, straw at 0.01 ppm; Sorghum, grain,
forage at 0.01 ppm; Sorghum, grain, grain at 0.01 ppm; Sorghum, grain,
stover at 0.01 ppm; Wheat, forage at 0.015 ppm; Wheat, grain at 0.01
ppm; Wheat, hay at 0.06 ppm; and Wheat, straw at 0.01 ppm upon approval
of the tolerances listed above. EPA has determined that the petition
contains data or information regarding the elements set forth in section
408 (d)(2) of FDDCA; however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. Plant metabolism data were studied for corn,
wheat, soybean, Swiss chard, and canola to support the seed treatment
uses of sedaxane. Studies for all commodities reflected labeling in both
the phenyl and pyrazole rings. Application rates were equal to, or
exaggerations of the currently proposed use rates, and application
techniques reflect the requested use patterns.

The metabolic pathway in wheat, soybeans, and Swiss chard is
substantially similar. Radioactivity levels were too low from corn and
canola samples to elucidate the metabolic pathways in these crops.
Following seed treatment use of sedaxane in wheat, soybean, and Swiss
chard, sedaxane metabolism may be summarized as follows: 1) oxidative
metabolism of the phenyl and cyclopropane rings, 2) N-demethylation of
the pyrazole ring and 3) cleavage between pyrazole and phenyl rings.
Among the three crops studied, there is variation in the extent of the
three reaction processes and the nature of the observed conjugates
found.

The seed treatment data on the metabolism of sedaxane in wheat, soybean,
and Swiss chard demonstrate that residues are generally low, but do
translocate throughout the plants. The highest residues are generally
found in the foliage or forage portions of plants, and not in the seeds
or grains of these commodities. Crop field trial residue data were
consistent with the results of the plant metabolism studies.
Specifically, the magnitude of the residue studies showed no
quantifiable residues of sedaxane in any human food plant parts, but low
level residues were found in some livestock feedstuffs associated with
these plants.

	2. Analytical method. Various crops were analyzed for sedaxane (parent
only) using a procedure for analysis of sedaxane (SYN524464) that can
distinguish between its trans and cis isomers (SYN508210 and SYN508211).
Plant matrices using method GRM023.01A or modified method GRM023.01B are
taken through an extraction procedure with final determination by high
performance liquid chromatography with triple quadrupole mass
spectrometric detection (LC-MS/MS).

Method GRM023.01A (and therefore GRM023.01B, which uses the same
procedure) was validated on a range of plant commodities fortified with
the trans and cis isomers SYN508210 and SYN508211 at the proposed limit
of quantification (LOQ) of the method (0.005 mg/kg for SYN508210 and
SYN508211) and either at 10 times the LOQ or at the potential MRL.

The plant matrices included plants from each of the crop commodities
identified in OECD Guidance ENV/JM/MONO(2007)17, including wheat grain,
wheat straw, wheat whole plant, lentils, and oilseed rape seed as a few
of those crops tested. The mean SYN508210 and SYN508211 recoveries for
both primary quantification and confirmatory transitions at each
fortification level and overall for each crop commodity tested during
method validation were 76% – 102%. The limit of quantification for
SYN508210 and SYN508211 residues in crop commodities using method
GRM023.01A was established at 0.005 mg/kg.

	3. Magnitude of residues. Syngenta Crop Protection, LLC has submitted
complete residue data for peanut; peanut, hay; rice, grain; and rice,
straw.

B. Toxicological Profile

	1. Acute toxicity. Sedaxane has low acute toxicity by the oral, dermal
and inhalation routes. It is not a dermal sensitizer, causes no skin
irritation and only slight eye irritation.

	2. Genotoxicty. Sedaxane was negative (non-mutagenic) in an in vitro
bacterial reverse mutation assay, an in vitro gene mutation assay in
mammalian cells, an in vitro cytogenetics study, an in vivo unscheduled
DNA synthesis study, and an in vivo rat bone marrow micronucleus assay.

	3. Reproductive and developmental toxicity. Sedaxane was evaluated for
potential to cause effects on reproductive and developmental toxicity in
a multi-generation reproductive toxicity study in the rat and in
pre-natal developmental toxicity studies in the rat and rabbit. There
were no adverse effects on reproduction or fertility up to the top dose
level of 1500 ppm. Therefore this high dose represented the NOAEL for
reproductive toxicity.

There were no indications of any differences in sensitivity to sedaxane
between the different generations or between parental animals and
offspring. There were no adverse effects at a dose level of 500 ppm in
adults or pups, indicating that this was the NOAEL for parental and
offspring toxicity.

Data from both the rat and rabbit developmental toxicity studies with
sedaxane showed no potential for teratogenic effects, and the fetal
NOAEL values were equal to or higher than the maternal NOAEL values,
indicating a lack of sensitivity of developing offspring to the effects
of sedaxane.

	4. Subchronic toxicity. The short-term toxicity of sedaxane has been
evaluated by the oral route of administration in rats, dogs and mice. In
addition, dermal toxicity was evaluated in rats in a 28-day study.

Sedaxane is generally of a low order of toxicity in all species tested
in short term studies. Rats were slightly more sensitive to the general
systemic effects of sedaxane treatment than were dogs. Mice were
relatively non-responsive except at dose levels at a limit dose for
studies of this type (7000 ppm). A NOAEL of 28 mg/kg/day (300 ppm) was
achieved in the second 90-day rat study for female rats.

In rats, treatment-related effects were seen consistently in the liver,
indicating that this is a target organ for sedaxane. At dose levels of
2000 ppm and 1000 ppm in the 90-day rat studies, slight increases in
liver weight were seen in males and females, with no micropathological
findings. The increases are therefore consistent with adaptive changes
and were considered non-adverse. No effects on liver weights or
micropathology were seen at 250 or 300 ppm in these studies.

In male and female rats, increased incidence of thyroid follicular cell
hypertrophy was observed only at the 4000 ppm dose level in the second
90-day rat study. There were no effects in this organ in the first
90-day rat study. A chronic/carcinogenicity study in rats also showed
similar low level changes of follicular cell hypertrophy in male and
female rats after 52 weeks of treatment at 1200 and 3600 ppm dose
levels. Overall, the response in the thyroid of rats was relative mild
and was variable between studies and laboratories.

In dogs, liver weights were higher than control values in male and
female dogs after one year at 200 mg/kg/day, but in the absence of
micropathology findings this was considered non-adverse. In the 90-day
dog study, there were no effects on liver weights and no differences
from control animals in liver micropathology. There were no adverse
effects on the thyroid in any study in the dog including the 1 year
study. A NOAEL of 50 mg/kg/day was achieved in both the 90-day and
1-year dog studies, based on initially lower food consumption and
consistently lower cumulative bodyweight gains at 150 mg/kg/day and
higher.

In mice, no adverse effects of treatment were observed in the 28-day
study at dose levels up to 7000 ppm. Decreased bodyweight gain and food
utilization were observed in male mice at 7000 ppm in the 90-day study,
but not in females. No micropathology changes were observed in either
study and the few differences in certain hematology, clinical chemistry
or organ weight values were inconsistent between the two studies and not
considered adverse. In the 90-day study, a NOAEL of 567 mg/kg/day (3500
ppm) was achieved in male mice.

In a 28-day dermal toxicity study in rats, no treatment-related effects
were observed at any dose level up to the limit dose of 1000 mg/kg/day.

In an acute neurotoxicity study in rats, no neuropathology was observed
at any dose level, and the NOAEL for neurotoxicity was 2000 mg/kg. The
NOAEL for general toxicity in this study was 30 mg/kg, based on effects
on body weight, food consumption, and clinical signs at 250 mg/kg. For
use in acute risk assessments, EPA derived an acute reference dose
(aRfD) of 0.30 mg/kg/day based on the NOAEL of 30 mg/kg from this acute
neurotoxicity study.

In a subchronic neurotoxicity study, sedaxane did not produce any
evidence of neurotoxicity in rats at dose levels of 0, 300, 1000 and
4000 ppm for 90 days. A NOAEL for general toxicity was observed at 1000
ppm, equivalent to 66.0/79.7 mg/kg/day in male and female rats,
respectively.

	5. Chronic toxicity. Sedaxane has been evaluated for chronic toxicity
in the rat and for carcinogenic potential in the rat and the mouse.

In a 2 year combined rat chronic toxicity/carcinogenicity study
conducted at dietary inclusion levels of 0, 200, 1200 and 3600 ppm,
there were no treatment related effects on survival. There was a marked
deficit in body weight gain at 3600 ppm which was evidenced throughout
the entire study. The extent of the body weight effect increased
substantially during the course of the study and by the end of the study
represented a 24% and 50% decrease in body weight gain in males and
females, respectively. The magnitude of the effect at 3600 ppm was
considered to be greater than that required for an adequate evaluation
of carcinogenic potential. At 1200 ppm, body weight gain was a maximum
of 11% lower than control in females, which was considered to be of
sufficient magnitude to provide a robust assessment of carcinogenic
potential. The NOEL was 200 ppm for both males and females, equating to
11 mg/kg/day in males and 14 mg/kg/day in females. The LOAEL was 1200
ppm.

In a carcinogenicity study in the mouse, groups of 50 male and 50 female
CD-1 mice were fed diets containing 0, 200, 1250 and 7000 ppm of
Sedaxane for a period of at least 80 weeks. There were no treatment
related effects on survival and no treatment-related clinical signs.
Effects at the LOAEL and above included decreased body weight and body
weight gain and food utilization in males and females. The NOAEL for
this study was 1250 ppm for both sexes, equating to achieved dose levels
of 157 mg Sedaxane/kg/day in males and 185 mg Sedaxane/kg/day in
females.

The EPA considered that sedaxane produced an increased incidence of
liver tumors and thyroid tumors in male rats, and uterine tumors in
female rats at the high dose of 3600 ppm. In the 18-month mouse study,
EPA considered that an increase in liver tumors in male mice was
treatment-related at the limit dose of 7000 ppm. Based on these results,
a Q1* value of 0.00464 (mg/kg/day)-1 was assigned for use in cancer risk
assessments with sedaxane. For non-cancer risk assessments of chronic
exposures, a chronic reference dose (cRfD) of 0.11 mg/kg/day was
assigned, based on the NOAEL of 11 mg/kg/day in the 2-year rat study.

	6. Animal metabolism. In both poultry and goat, the majority of the
dosed radioactivity was excreted (mainly in the feces of the goat) and
residues in tissues, milk and eggs were low. In the goat study, milk
residues reached plateau very rapidly, after just 2 days (reaching a
maximum of 0.045 mg/kg). Residues in eggs from the hen study reached a
plateau after approximately 9 days (reaching a maximum of 0.015 mg/kg in
egg white and 0.089 mg/kg in egg yolk).

	In both species, the highest tissue residues were observed in liver,
0.26 mg/kg in hen and 0.61 mg/kg in goat. Residues in muscle were <0.006
mg/kg and in fat were <0.016 mg/kg. In the goat kidney residues
represented <0.19 mg/kg.

	Metabolic profiles observed in livestock commodities and excreta arise
from just a few types of biotransformation. The principal routes of
metabolism are oxidation resulting in hydroxylation of the phenyl ring
or at the cyclopropane moiety. Additionally the same oxidations are
observed following demethylation of sedaxane. Overall results showed
that the biotransformation pathway of sedaxane in ruminants and poultry
is very similar to that observed in the rat.

	7. Metabolite toxicology. CSCD465008 (formed via cleavage of the
carboxamide link in the pyrazole labeled aerobic soil study) has been
assessed for acute oral toxicity, in vitro genotoxicity (Bacterial
reverse mutation, in vitro cytogenics and mammalian gene cell mutation)
and repeat oral toxicity for up to 28 days. CSCD465008 was not acutely
toxic by the oral route, not genotoxic in vitro and did not result in
any toxicologically significant effects at dose levels exceeding 1000
mg/kg-bw/day, the limit dose for a 28-day toxicity study in rats.

	8. Endocrine disruption. Sedaxane does not belong to a class of
chemicals known or suspected of having adverse effects on the endocrine
system. Furthermore, supporting developmental toxicity studies in rats
and rabbits, and a reproduction study in rats gave no indication of any
effects on endocrine function related to development and reproduction.
Subchronic and chronic treatment did not induce any morphological
changes in endocrine organs and tissues.

9. Immunotoxicity. A study was conducted, as specified in US EPA OPPTS
Guideline 870.7800, to provide information on suppression of the immune
system which might occur as a result of repeated exposure to a test
chemical.

Treatment of male CD-1 mice with sedaxane on a continuous basis in the
diet for a minimum of 28 days resulted in no suppression of the humoral
immune component of the immune system, based on an evaluation of the
spleen and thymus weights, spleen cell numbers, and the T-cell dependent
antibody response of splenocytes (antibody forming cell assay). The no
observed-effect level (NOEL) for suppression of the immune response in
male CD-1 mice offered sedaxane on a continuous basis in the diet for a
minimum of 28 days at 0, 500, 2000, and 5500 ppm was 5500 ppm
(equivalent to 1084 mg/kg/day). The only effect attributed to
sedaxane-treatment was a slightly higher mean adjusted liver weight for
the 5500 ppm group that was not considered adverse.

C. Aggregate Exposure

	1. Dietary exposure. Tier I acute, Tier III chronic and lifetime cancer
aggregate exposure assessments were performed for sedaxane (SYN524464),
a mixture of its cis- (SYN508210) and trans- (SYN508211) isomers using
the Dietary Exposure Model (DEEM-FCID™ Version 4.02, Evaluation Copy);
consumption data was from the USDA NHANES “What We Eat in America”
survey, 2005-2010. The definition of the residue for tolerance
enforcement and risk assessment purposes for crops is parent sedaxane
(SYN508210 plus SYN508211). Assessments were conducted for all current
uses and proposed seed treatment uses on peanut; grain, cereal, group
15; and grain, cereal, forage, fodder and straw, group 16. The Tier I
acute assessments incorporated established (40 CFR 180.665) or proposed
tolerances values for all crops where sedaxane was applied at the
maximum intended seed treatment use rate and crops harvested at the
minimum pre-harvest interval (PHI) to obtain the maximum expected
residues. Percent of crop treated (%CT) was conservatively assumed to be
100% for the acute assessments. The Tier III chronic assessments
incorporated field trial residue values where sedaxane was applied at
the maximum intended use rate and crops harvested at the minimum PHI to
obtain the maximum expected residues. Estimated %CT values were
incorporated into the Tier III chronic assessments based upon economic,
pest, and competitive pressures. Anticipated residues in meat, milk, and
eggs were estimated based on “maximum reasonably balanced diets” and
transfer information from goat and hen metabolism studies. Drinking
water estimates were selected using the higher of the estimated drinking
water concentrations (EDWCs) for surface and ground water.

	i. Food. Acute Exposure. Acute food-only risk assessments for parent
sedaxane (SYN508210 plus SYN508211) were performed for all population
sub-groups using an acute reference dose of 0.30 mg/kg-bw/day, based
upon a neurotoxicity study in rats with a no observed adverse effect
level (NOAEL) of 30 mg/kg-bw/day and an uncertainty factor of 100X. The
100X safety factor includes intra- and inter-species variations; no
additional FQPA safety factor was applied. For the purpose of aggregate
risk assessment, the exposure values were expressed in terms of margin
of exposure (MOE), which was calculated by dividing the NOAEL by the
exposure for each population subgroup. In addition, exposure was
expressed as a percent of the acute reference dose (%aRfD). Acute food
exposure to the U.S. population resulted in a MOE of 222,615 (<0.1% of
the aRfD of 0.30 mg/kg-bw/day). The most exposed sub-population was
children (1-2 years old) with a MOE of 102,772 (0.1% of the aRfD of 0.30
mg/kg-bw/day). Since the Benchmark MOE for this assessment was 100 and
since the EPA generally has no concern for exposures above the benchmark
or below 100% of the reference dose, Syngenta believes that there is a
reasonable certainty that no harm will result from acute food exposures
to residues arising from all current and proposed uses of sedaxane.

Chronic Exposure. Chronic food-only risk assessments for parent sedaxane
(SYN508210 plus SYN508211) were performed for all population sub-groups
using a chronic reference dose of 0.11 mg/kg-bw/day, based upon a
chronic rat study with a no observed adverse effect level (NOAEL) of 11
mg/kg-bw/day and an uncertainty factor of 100X. The 100X safety factor
includes intra- and inter-species variations; no additional FQPA safety
factor was applied. For the purpose of aggregate risk assessment, the
exposure values were expressed in terms of margin of exposure (MOE),
which was calculated by dividing the NOAEL by the exposure for each
population subgroup. In addition, exposure was expressed as a percent of
the chronic reference dose (%cRfD). Chronic food exposure to the U.S.
population resulted in a MOE of 359,417 (<0.1% of the cRfD of 0.11
mg/kg-bw/day). The most exposed sub-population was children (1-2 years
old) with a MOE of 138,273 (0.1% of the cRfD of 0.11 mg/kg-bw/day).
Since the Benchmark MOE for this assessment was 100 and since the EPA
generally has no concern for exposures above the benchmark or below 100%
of the reference dose, Syngenta believes that there is a reasonable
certainty that no harm will result from chronic food exposures to
residues arising from all current and proposed uses of sedaxane.

Cancer Risk from Food. Lifetime cancer food risk from sedaxane was
evaluated by comparing exposures to a Q1* value of 0.0046
(mg/kg-bw/day)-1 based on two rodent carcinogenicity studies. Lifetime
cancer food risk for the U.S. population was 1.43 x 10-7. The EPA’s
Benchmark range for lifetime cancer risks is 1 x 10-6 or less to be
negligible. Since the EPA generally has no concern for exposures at or
below the benchmark range, Syngenta believes that there is a reasonable
certainty that no harm will result from lifetime cancer food exposures
to residues arising from all current and proposed uses of sedaxane.

	ii. Drinking water. The estimated drinking water concentrations (EDWCs)
of sedaxane total toxic residues (TTR), a mixture of sedaxane and its
degradates (CDCD668094 and CDCD668095), were derived from Tier I
Screening Concentration In GROund Water (SCI-GROW v2.3) and Tier II
Pesticide Root Zone Model for Ground Water (PRZM-GW v1.07) for ground
water, Tier I FQPA Index Reservoir Screening Tool (FIRST v1.1.1) and
Modified Tier 1 Rice model for surface water from terrestrial and
aquatic uses, respectively. Model simulations included currently
registered uses and the proposed seed treatment uses on peanut; grain,
cereal, group 15; and grain, cereal, forage, fodder and straw, group 16.
The highest EDWC for ground water, generated from Tier II PRZM-GW based
on the registered seed treatment use on potato, was 0.32 ppb for acute
and chronic exposure durations. The highest EDWCs for surface water,
generated from Modified Tier I Rice Model modelling of the proposed seed
treatment use of sedaxane on rice grains, were 15.2 ppb and 13.5 ppb for
acute and chronic exposure durations, respectively. Percent cropped area
(PCA) adjustment factor of 0.91 was applied to the surface water EDWCs.
The acute and chronic surface water EDWCs were used for risk assessment
purposes and will be considered protective for any ground water exposure
concerns.

Acute Exposure from Drinking Water. The acute surface water EDWC of 15.2
ppb was input directly into the DEEM-FCID™ software as “water,
direct and indirect, all sources” to model the acute drinking water
exposures. Exposure contributions at the 95%-ile of exposures were
determined by taking the difference between the aggregate (food +
drinking water) exposures and the food (alone) exposures for each
population subgroup. Acute drinking water exposure U.S. population
resulted in a MOE of 40,268 (0.2% of the acute RfD of 0.30
mg/kg-bw/day). The most exposed sub-population was all infants (<1 year
old) with a MOE of 10,965 (0.9% of the acute RfD of 0.30 mg/kg/day).
Since the benchmark MOE for this assessment was 100 and since EPA
generally has no concern for exposures below 100% of the acute RfD,
Syngenta believes that there is a reasonable certainty that no harm will
result from acute drinking water exposure to residues arising from the
current and proposed uses for sedaxane.

Chronic Exposure from Drinking Water. The chronic surface water EDWC of
13.5 ppb was input directly into the DEEM-FCID™ software as “water,
direct and indirect, all sources” to model the chronic drinking water
exposures. Chronic drinking water exposure to the U.S. population
resulted in a MOE of 40,329 (0.2% of the chronic RfD of 0.11
mg/kg-bw/day). Chronic drinking water exposure to the most exposed
sub-population (infants, <1 year old) resulted in a MOE of 10,796 (0.9%
of the chronic RfD of 0.11 mg/kg-bw/day). Since the Benchmark MOE for
this assessment was 100 and since EPA generally has no concern for
exposures below 100% of the chronic RfD, Syngenta believes that there is
a reasonable certainty that no harm will result from chronic drinking
water exposure to residues arising from the current and proposed uses
for sedaxane.

	2. Non-dietary exposure. There are no currently registered residential
uses for sedaxane, so a non-dietary residential exposure assessment was
not conducted.

D. Cumulative Effects

	Cumulative Exposure to Substances with a Common Mechanism of Toxicity.
Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity”. Syngenta did not perform a cumulative
risk assessment as part of this tolerance action for sedaxane because
HED has not yet determined that there are any other chemical substances
that have a mechanism of toxicity common with that of sedaxane.

E. Safety Determination

	1. U.S. population. The acute aggregate exposure analysis (food plus
water) for all current and proposed uses of sedaxane resulted in a MOE
of 34,079 for the U.S. population (0.3% of the aRfD of 0.30
mg/kg-bw/day) which exceeds the Benchmark MOE of 100. The chronic
aggregate exposure analysis (food plus water) for all current and
proposed uses of sedaxane resulted in a MOE of 36,260 for the U.S.
population (0.2% of the cRfD of 0.11 mg/kg-bw/day) which exceeds the
Benchmark MOE of 100. Based on the completeness and reliability of the
toxicity data supporting these petitions, Syngenta believes that there
is a reasonable certainty that no harm will occur to the U.S. population
from acute and chronic aggregate exposures arising from all current and
proposed uses of sedaxane. The lifetime cancer risk analysis for all
current and proposed uses of sedaxane resulted in a lifetime cancer risk
estimate of 1.4 x 10-6 for the U.S. population. The EPA generally
considers cancer risk in the range of 10-6 or less to be negligible. The
precision that can be assumed for cancer risk estimates is best
described by rounding to the nearest integral order of magnitude on the
log scale. Considering the precision with which cancer hazard can be
estimated, the conservativeness of low-dose linear extrapolation, and
the described rounding procedure, cancer risk is generally not assumed
to exceed the benchmark level of concern of the range of 10-6 until the
calculated risk exceeds approximately 3 x 10-6 (80 FR 43323). Based on
this approach, Syngenta considers the risks of cancer from exposure to
be negligible.

	2. Infants and children. The acute aggregate exposure analysis (food
plus water) for all current and proposed uses of sedaxane resulted in a
MOE of 10,221 (1.0% of the aRfD of 0.30 mg/kg-bw/day) for the most
sensitive population subgroup, all infants, which exceeds the Benchmark
MOE of 100. The chronic aggregate exposure analysis (food plus water)
for all current and proposed uses of sedaxane resulted in a MOE of
10,265 (0.9% of the cRfD of 0.11 mg/kg-bw/day) for the most sensitive
population subgroup, all infants, which exceeds the Benchmark MOE of
100. Based on the completeness and reliability of the toxicity data
supporting these petitions, Syngenta believes that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to residues arising from all current and proposed
uses of sedaxane.

F. International Tolerances

	Codex maximum residue levels (MRLs) have been established for residues
of sedaxane on cereals, rape seed, soya bean (dry) and animal
commodities.

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