[Federal Register Volume 85, Number 46 (Monday, March 9, 2020)]
[Notices]
[Page 13700]
[FR Doc No: C1-2020-04106]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2019-0020; Notice 1]

FCA US, LLC, Receipt of Petition for Decision of Inconsequential
Noncompliance

Correction

    In notice document 2020-04106, appearing on pages 12059-12062 in
the issue of Friday, February 28, 2020, make the following correction:
    On page 12059, in the third column, on the tenth line from the top,
``February 28, 2020'' is corrected to read ``March 30, 2020.''

[FR Doc. C1-2020-04106 Filed 3-6-20; 8:45 am]
BILLING CODE 1301-00-D


[Federal Register: December 12, 2007 (Volume 72, Number 238)]
[Notices]
[Page 70581]
[DOCID:fr12de07-34]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

December 6, 2007.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP00-70-017.
    Applicants: Algonquin Gas Transmission, LLC
    Description: Algonquin Gas Transmission, LLC submits First Revised
Sheet 87 to FERC Gas Tariff, Fifth Revised Volume 1.
    Filed Date: 12/03/2007.
    Accession Number: 20071205-0105.
    Comment Date: 5 p.m. Eastern Time on Monday, December 17, 2007.

    Docket Numbers: RP07-478-003.
    Applicants: Columbia Gulf Transmission Company.
    Description: Columbia Gulf Transmission Company's First Revised
Sheet 333E et al. to FERC Gas Tariff, Second Revised Volume 1.
    Filed Date: 11/30/2007.
    Accession Number: 20071203-0251.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 12, 2007.

    Docket Numbers: RP08-106-000.
    Applicants: El Paso Natural Gas Company.
    Description: El Paso Natural Gas Company submits Sixteenth Revised
Sheet 29 to its FERC Gas Tariff, Second Revised Volume 1, effective 1/
1/08.
    Filed Date: 12/03/2007.
    Accession Number: 20071205-0106.
    Comment Date: 5 p.m. Eastern Time on Monday, December 17, 2007.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E7-24039 Filed 12-11-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 217 (Monday, November 10, 2014)]
[Notices]
[Pages 66763-66765]
[FR Doc No: 2014-26668]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

DEPARTMENT OF INTERIOR

National Park Service

[Docket No. FAA-2014-0782]

Grand Canyon National Park Quiet Aircraft Technology Incentive:
Seasonal Relief From Allocations in the Dragon and Zuni Point Corridors

    Authority: Moving Ahead for Progress in the 21st Century Act,
Sec. 35001, Public Law 112-141, 126 Stat. 843; National Parks Air
Tour Management Act, Sec. 804, Public Law 106-181, 114 Stat. 192.

AGENCY: Federal Aviation Administration, Transportation; National Park
Service, Interior.

ACTION: Notice and request for public comment.

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SUMMARY: The Moving Ahead for Progress in the 21st Century Act (MAP-21)
in section 35001(b)(2) directs the Administrator of the Federal
Aviation Administration (FAA) and the Secretary of the Interior to
provide quiet aircraft technology incentives for commercial air tour
operators at Grand Canyon National Park. The FAA and the National Park
Service (NPS) propose to implement this directive by giving effect to
section 804(c) of the National Parks Air Tour Management Act (NPATMA)
to provide seasonal relief from allocations in the Dragon and Zuni
Point corridors for commercial air tour operators that convert or have
converted to quiet aircraft technology. The FAA and the NPS will ensure
that seasonal relief from allocations complies with statutory
conditions that the cumulative impact of such operations does not
increase noise at the Grand Canyon and that this incentive does not
diminish the statutory mandate to achieve the substantial restoration
of natural quiet. This incentive is proposed to be made available in
the Dragon and Zuni Point corridors during the first quarter (January-
March) beginning in 2015, may be extended to include part or all of the
fourth quarter beginning in 2016, and will remain in effect unless it
violates the statutory conditions or until a longer term approach for
managing air tour noise is in place.

DATES: Send comments on or before December 10, 2014.

ADDRESSES: Send comments identified by docket number FAA-2014-0782
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: All comments received will be posted, without change, to
http://www.regulations.gov, including any personal information the
commenter provides. Using the search function of the docket Web site,
anyone can find and read the electronic form of all comments received
into any docket, including the name of the individual sending the
comment (or signing the

comment for an association, business, labor union, etc.). DOT's
complete Privacy Act Statement can be found in the Federal Register
published on April 11, 2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT:
Keith Lusk, Program Manager, Federal Aviation Administration, P.O. Box
92007, Los Angeles, California 90009-2007; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Robin Martin, Chief, Office of Planning and Compliance, Grand Canyon
National Park, P.O. Box 129, Grand Canyon, Arizona 86023-0129;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Authority

    1. The National Park Overflights Act of 1987, Public Law 100-91,
directed the Secretary of the Interior and the Administrator of the FAA
to take actions to provide for the substantial restoration of the
natural quiet and experience of Grand Canyon National Park and the
protection of public health and safety from adverse effects associated
with aircraft overflight. As part of these actions, operational limits
for commercial air tour operations at Grand Canyon National Park (the
park) were imposed by FAA regulations at 14 CFR part 93 issued on April
4, 2000. With some exceptions not relevant to this notice, these
regulations establish an allocation scheme for the park, require
commercial air tour operators to use one allocation for each flight
that is a commercial air tour, and prohibit operators from conducting
more commercial air tours in any calendar year than the number of
allocations specified on the certificate holder's operations
specifications issued by the FAA. 14 CFR 93.319. These regulations also
define and describe quiet aircraft technology (QT). 14 CFR 93.303 and
appendix A to subpart U of part 93.
    2. The National Parks Air Tour Management Act (NPATMA), Public Law
106-181, was signed into law on April 5, 2000. Under section 804(c),
commercial air tour operations by any fixed-wing or helicopter aircraft
that employs QT and that replaces an existing aircraft are not subject
to the operational flight allocations that apply to other commercial
air tour operations at the park, provided that the cumulative impact of
such operations does not increase noise at the Grand Canyon. Section
804(d) provides that a commercial air tour operation by an aircraft in
a commercial air tour operator's fleet on the date of enactment of
NPATMA that meets QT requirements or is subsequently modified to meet
QT requirements may be used for commercial air tour operations under
the same terms and conditions as section 804(c) without regard to
whether it replaces an existing aircraft. In addition, NPATMA expressly
states that it does not relieve or diminish the statutory mandate to
achieve substantial restoration of natural quiet and experience at the
park.
    3. Section 35001 of the Moving Ahead for Progress in the 21st
Century Act (MAP-21), Public Law 112-141, July 6, 2012, directs the
Secretary of the Interior and the Administrator of the Federal Aviation
Administration to provide incentives for commercial air tour operators
that convert to QT, determined in accordance with the regulations then
in effect. MAP-21 gives as an example of an incentive increasing the
flight allocations for operators of QT on a net basis consistent with
section 804(c) of NPATMA, provided that the cumulative impact of such
operations does not increase noise at the Grand Canyon.

II. Current QT Incentives

    This proposed incentive is one of several that the FAA and the NPS
are providing for operators that convert or have converted to QT to
encourage greater use of QT. The NPS, in consultation with the FAA,
reduced the fees applicable to commercial air tour operations at the
Grand Canyon by 20 percent (from $25 to $20 per flight) for an air tour
using QT. This fee reduction went into effect on January 1, 2014.
    On February 3, 2014, the FAA, in consultation with the NPS,
announced its intention to distribute FAA-held allocations to
commercial tour operators in proportion to the number of QT operations
flown in the first six months of 2014. 79 FR 6267. These allocations
are to be used for QT flights during the 2014 air tour season and
beyond.

III. Seasonal Relief From Allocations for QT in the Dragon and Zuni
Point Corridors

    The FAA and the NPS propose to provide an additional QT incentive
in the Dragon and Zuni Point corridors where QT can have the greatest
positive effect on park resources and where the need for relief from
allocations has been demonstrated. Under this proposed incentive,
commercial air tour operators flying QT aircraft in the Dragon and Zuni
Point corridors will initially be relieved from having such operations
count against their annual allocations in the first quarter (January 1-
March 31) of 2015. During this first quarter, QT flights will not use
an allocation, while non-QT flights must still use an allocation. All
commercial air tour flights, QT and non-QT, must use an allocation for
the remainder of the year (April 1-December 31). However, operators
will continue to benefit from the seasonal relief since they may use
allocations in April through December that would otherwise have been
used for QT flights conducted in January through March.
    The first quarter of the calendar year has historically had the
lowest level of commercial air tour operations. Providing this
incentive initially in the first quarter of 2015 is a prudent action
that gives the FAA and the NPS an opportunity to evaluate the impact of
the incentive, including the extent to which commercial air tour
operators continue to use QT in the remainder of the year, which will
produce additional noise benefits for the park. The FAA and the NPS
want to incentivize commercial air tour operators to maximize the use
of QT throughout the year. To that end, the seasonal relief from
allocations may be extended to part or all of the fourth quarter
(October 1-December 31) in 2016 and following years, in addition to the
first quarter, based on an evaluation of the preceding year. In 2015,
the more that increased QT use reduces the noise level below the noise
baseline described in the following paragraph, the greater the prospect
for operators to have additional seasonal relief from allocations in
2016.
    To meet the statutory conditions in NPATMA and MAP-21, the FAA and
the NPS must ensure that the cumulative impact of QT operations
relieved from allocations does not increase noise at the park. For this
proposed seasonal relief incentive, this means that the annual noise
from both QT and non-QT commercial air tour flights conducted in the
Dragon and Zuni Point corridors must not exceed the annual noise level
of commercial air tour flights in these corridors under the current
allocation system. The FAA and the NPS have modeled the noise of
commercial air tour allocations in the Dragon and Zuni Point corridors
as flown with the 2012 commercial air tour fleet mix and route
structure--resulting

in a noise baseline of LEQ12 58.1 dB.\1\ To determine if
there is an increase in noise associated with this incentive, the FAA
and the NPS will model the annual noise from all commercial air tour
operations conducted in the Dragon and Zuni Point corridors and compare
the annual noise with the seasonal relief incentive in place with the
noise baseline of all commercial air tour allocations in these
corridors. Noise will be determined to increase if the annual modeled
LEQ12 noise of commercial air tour operations in the Dragon
and Zuni Point corridors exceeds LEQ12 58.1 dB. If noise in
any year exceeds the noise baseline, the seasonal relief incentive will
be modified or discontinued as determined necessary to comply with the
statutory condition.
---------------------------------------------------------------------------

    \1\ LEQ12 stands for Equivalent Sound Level for 12
hours, which is a cumulative measure of the noise exposure of A-
weighted sound levels over a 12-hour period. For this purpose, the
LEQ was calculated annually and averaged over the park to get a
single LEQ12 value.
---------------------------------------------------------------------------

    To ensure that this incentive will not diminish the achievement of
substantial restoration of natural quiet and experience at the park,
all commercial air tour aircraft including QT must adhere to the
existing route structure throughout the park, including the Dragon and
Zuni Point corridors.
    This incentive applies only to commercial air tour operators that
currently have allocations in the Dragon and Zuni Point corridors;
i.e., operators must have allocations in these corridors in order to be
relieved from allocations. It does not apply elsewhere in the Grand
Canyon Special Flight Rules Area (SFRA). There is an ample unused
surplus of commercial air tour allocations in the SFRA outside of the
Dragon and Zuni Point corridors; therefore, operators conducting air
tours in these other SFRA areas do not need relief from allocations and
would not be incentivized to convert to QT by a seasonal relief
incentive.
    If the seasonal relief in the Dragon and Zuni Point corridors is a
successful QT incentive, it is proposed to remain in effect unless it
violates the statutory condition that the cumulative effect of such
operations must not increase noise at the Grand Canyon or diminishes
the achievement of substantial restoration of natural quiet, in which
case it will be either modified or discontinued; or until a longer term
approach for managing air tour noise in the park is in place.
    The FAA and the NPS commit to developing a long term approach for
managing noise in the park in an expeditious manner. Any long term
approach will continue to incentivize conversion to QT and will not
penalize earlier conversion to QT realized through the seasonal relief
incentive.

IV. Implementation Steps

    All comments on this proposed incentive will be considered and will
inform the agencies' next steps. If the agencies proceed with the
seasonal relief incentive as proposed in this notice or as modified in
response to comments, the FAA will implement the incentive by amending
the operations specifications of commercial air tour operators holding
allocations in the Dragon and Zuni Point corridors to allow them to
conduct air tours with QT aircraft without using an allocation for such
tours in the specified seasonal time periods. The FAA and the NPS will
cooperatively ensure that the statutory conditions protecting the park
are met.

V. Environmental Considerations

    This action involving the FAA's amendment of operations
specifications is categorically excluded from more detailed
environmental review because it would not have a significant effect on
the environment. The FAA and the NPS have designed this incentive to
ensure compliance with the statutory conditions that the cumulative
impact of QT operating without allocations does not increase noise and
that the incentive does not diminish the statutory mandate to achieve
the substantial restoration of natural quiet at the park.

    Issued in Hawthorne, CA, on October 7, 2014.
Glen A. Martin,
Regional Administrator, Western-Pacific Region, Federal Aviation
Administration.
    Issued in Lakewood, CO, on October 16, 2014.
Sue E. Masica,
Regional Director, Intermountain Region, National Park Service.
[FR Doc. 2014-26668 Filed 11-7-14; 8:45 am]
BILLING CODE 4910-13-P


FILE NAME:   company.wpt   (1/1/2006) (xml)

Template Number P25

ATTENTION:

All commodity terms must comply with the Food and Feed Commodity
Vocabulary database (http://www.epa.gov/pesticides/foodfeed/).

All text in blue font (instructions for preparing the document), should
be removed prior to sending the document to the Federal Register Staff.
Instructional text and prompts in green font should also be removed.

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

(Template Number P25; 1/1/2006)

EPA Registration Division contact: [Barbara Madden,<PHONE_NUMBER>]

INSTRUCTIONS:  Please utilize this outline in preparing tolerance
petition documents.  In cases where the outline element does not apply
please insert “NA-Remove” and maintain the outline.  The comment
notes that appear on the left margin represent hidden typesetting codes
designed to expedite the processing of the Federal Register document.
Please do not remove or alter these comment notes or change the margins,
font, or format  in your document. Simply replace the instructions that
appear in italics and brackets, i.e., “[insert company name],” with
the information specific to your action.

TEMPLATE:

[Interregional Research Project No. 4]

[Insert petition number]

 Summary of Petitions

	EPA has received pesticide petitions ([insert petition number]) from
[Interregional Research Project No. 4, 681 US Hwy. No. 1 South, North
Brunswick, NJ 08902-3390; and Bayer CropScience, 2 T.W. Alexander Drive,
Research Triangle Park, NC 27709] proposing, pursuant to section 408(d)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d),
to amend 40 CFR part 180 by establishing a tolerance for residues of
[fenamidone, [4H-imidazol-4-one,
3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-(phenylamino)-, (S)-],
in or on the raw agricultural commodity [vegetable, brassica, head and
stem, subgroup 5A] at [4.0] parts per million (ppm), [vegetable,
brassica, leafy greens, subgroup 5B] at [35] ppm, [vegetable, fruiting,
group 8] at [2.0] ppm, [vegetable, leafy, except brassica, group 4] at
[35] ppm, [carrot] at [0.15 ppm], [cotton, undelinted seed] at [0.02]
ppm, [cotton, gin byproducts] at [0.02 ppm], and [sunflower] at [0.08]
ppm; and establishing tolerances for combined inadvertent residues of
[fenamidone, [4H-imidazol-4-one,
3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-(phenyl-amino)-, (S)-]
and [its metabolite RPA 717879 (2,4-imidazolidinedione,
5-methyl-5-phenyl)] in or on [strawberries] at [0.02] ppm.  EPA has
determined that the petition contains 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 supports granting of the petition.  Additional data
may be needed before EPA rules on the petition.

A. Residue Chemistry

.  [The plant metabolism of fenamidone (RPA407213) was evaluated in
five distinct crops (lettuce, tomatoes, potatoes, carrots and grapes)
and is adequately understood.  In all cases, the primary residue was the
parent compound.  The only significant metabolite was RPA410193 (17% of
the total radioactive residue (TRR) in grapes, 9% of the total
radioactive residue (TRR) in tomatoes, <1% of the total radioactive
residue (TRR) in lettuce (mostly in the wrapper leaves), and <1% of the
total radioactive residue (TRR) in potatoes (haulm or tubers)), and
RPA406012 (4.5% of TRR in carrot tops).  RPA412708 and RPA412636 were
minor metabolites reported in the lettuce and potato studies and may
account for part of the unidentified residue reported in the grape and
tomato metabolism studies.]

.  [Although residue levels approaching the proposed tolerances are
unlikely, independently validated enforcement methods are available for
determining residues of fenamidone and relevant metabolites.  Residues
are first extracted from the crop matrix by blending or shaking with a
mixture of acetonitrile and water.  After filtration, an aliquot of the
extract is rotary evaporated to near dryness, then diluted with water.
Cleanup is accomplished on a HR-P polymeric solid phase extraction (SPE)
cartridge and an amino SPE cartridge.  Residues are quantified by HPLC
with tandem mass spectrometric detection (LC/MS/MS).  The method limits
of quantification (LOQ) are 0.02 ppm or lower for fenamidone, and its
metabolites, RPA 412636, RPA 412708, and RPA 410193 in test raw
agricultural commodities and processed fractions.]

.  [Complete residue data to support the requested tolerances on head
and stem brassica vegetables, leafy brassica greens, fruiting
vegetables, leafy vegetables, carrots, cotton, sunflower and
strawberries have been submitted to the Agency.]

B. Toxicological Profile

.  [A complete battery of acute toxicity studies for fenamidone has been
conducted.  The acute oral toxicity study in rats resulted in a LD50 of
>5000 mg/kg (males) and  >2028 mg/kg (females).  The acute dermal
toxicity study in rats resulted in a LD50 of >2000 mg/kg for both males
and females.  The acute inhalation study in rats resulted in a LC50 of >
5 mg/L for males and females.  Fenamidone was not irritating in the
primary eye irritation or primary dermal irritation studies.  The dermal
sensitization study in guinea pigs was negative.  In an acute
neurotoxicity study in rats, fenamidone was not neurotoxic at doses up
to the limit dose of 2000 mg/kg.  The NOEL was 500 mg/kg for males and
125 mg/kg for females.]

.  [Mutagenicity studies conducted include: a Salmonella typhimurium
reverse mutation assay (negative at the limits of cytotoxicity and
solubility with and without activation), in vitro unscheduled DNA
synthesis test in rat liver (negative at the limits of cytotoxicity), in
vitro chromosome aberrations test in human lymphocytes (positive at the
limits of cytotoxicity and solubility), TK+/- mouse lymphoma assay
(positive with activation, negative without), in vivo mouse micronucleus
test (negative with toxicity at 2000 mg/kg), and an in vivo unscheduled
DNA synthesis assay in the rat (negative at up to 2000 mg/kg with
toxicity at the high dose level).  Based on the data cited above,
fenamidone is not considered to be mutagenic.]

.  [A teratology study was conducted with rats administered (orally)
fenamidone on gestation days 6-15 at dose levels of 0, 25, 150, or 1000
mg/kg/day.  High dose dams had significantly decreased body weight and
food consumption.  High dose fetal body weights were less than controls
and correlated with slightly delayed skeletal ossification secondary to
maternal toxicity.  The NOEL for maternal and developmental toxicity is
150 mg/kg/day.  The LOEL was 1000 mg/kg/day.  A teratology study was
conducted with rabbits administered (orally) fenamidone on gestation
days 6-19 at dose levels of 0, 10, 30, or 100 mg/kg/day.  The maternal
NOEL was 10 mg/kg/day.  The developmental NOEL was 100 mg/kg/day.  The
maternal LOEL was 30 mg/kg/day, based on increased maternal liver
weights at 30 and 100 mg/kg/day.  Fenamidone demonstrates no potential
to cause developmental toxicity in mammals.  A two-generation definitive
reproduction study was conducted with rats administered (orally) in the
diet fenamidone at dose levels of 0, 3.9, 63.8, 328.3 mg/kg/day (males)
and 0, 5.15, 84.4, 459.6 mg/kg/day (females).  The NOEL for maternal and
offspring toxicity was 5.15 mg/kg/day.  The maternal NOEL was based on
decreased body weight and food consumption.  The pup NOEL is based on F1
pup body weight decrease. The reproductive NOEL was >328.3 mg/kg/day
(males) and >459.6 mg/kg/day (females).  Fenamidone is not considered a
reproductive toxicant at non-maternally toxic dose levels and shows no
evidence of endocrine effects. A developmental neurotoxicity study was
conducted with rats administered fenamidone on gestation days 6-20 at
dose levels of 0, 5.5, 23.2, 92.3, or 429 mg/kg/day, respectively. No
maternal deaths or clinical signs of toxicity were observed during the
study. However, at 429 mg/kg/day mean body weight gain was significantly
decreased. Litter viability and clinical signs in offsprings were
unaffected by treatment, but post-weaning body weight was significantly
decreased at the high dose of 429 mg/kg/day. The maternal NOAEL was 429
mg/kg/day and the offspring NOAEL was 92.3 mg/kg/day.]

  [In a 13-week range-finding study, fenamidone was administered in the
diets of male and female rats at dose levels of 0, 4.05, 10.41, 68.27,
343.93 mg/kg/day to males and 0, 4.81, 12, 83.33, 380.68 mg/kg/day to
females. The NOEL is 68.27 mg/kg/day (males) and 83.33 mg/kg/day
(females) and the LOEL is 343.93 mg/kg/day for males and 380.63
mg/kg/day for females based on adaptive liver changes at 68.27 mg/kg/day
and increased liver and thyroid weights at the highest dose tested.  In
a 13 week subchronic feeding study, fenamidone was administered in the
diet to mice at dose levels of 0, 11.33, 44.5, 220.2, 1064.3 mg/kg/day
to males and 0, 13.7, 54.1, 273.9, 1375.2 mg/kg/day to females. The NOEL
is 44.5mg/kg/day (males) and 54.1 mg/kg/day (females) and the LOEL is
220.2 mg/kg/day (males) and 273.9 mg/kg/day (females) based on 14%
increase in liver weight at the high dose. In a 28 day subchronic dermal
study, fenamidone was applied to skin of male and female New Zealand
white rabbits at doses of 0 or 1000 mg/kg/day for 6 hours/day, 5
days/week.  Treatment produced a slight decrease in food consumption
(8-10%) and body weight (6%) in males only.  In a 13-week study,
fenamidone was administered in the diets of male and female dogs at 0,
10, 100, and 500 mg/kg/day.  Based on clinical symptoms at the high
dose, the NOEL is 100 mg/kg/day and the LOEL is 500 mg/kg/day.  In a
subchronic neurotoxicity study, there was no evidence of neurotoxicity
when fenamidone technical was administered to rats for 13 weeks at
dosage levels up to 5000 ppm (395.6 and 414.2 mg/kg/day), the MTD.  The
NOEL for the study was 1000 ppm (equivalent to 74.2 and 83.4
mg/kg/day).]

.  [A 1-year oral study was conducted with dogs administered fenamidone
at dose levels of 0, 10, 100, and 1000 mg/kg/day in capsules.  The NOEL
is 100 mg/kg/day for both sexes, based on significantly increased liver
weights and biliary hyperplasia in the high dose.  The LOEL is 1000
mg/kg/day.  A 2-year combined chronic toxicity/ carcinogenicity study
was conducted with fenamidone administered in the diet to rats at doses
of 0, 2.83,7.07, 47.68, 260.13 mg/kg/day (males) and 0, 3.63, 9.24,
60.93, 335.10 mg/kg/day (females).  The no-observed-effect-level (NOEL)
for systemic toxicity is 2.83 mg/kg/day (males) and 3.36 mg/kg/day
(females).  The lowest-effect-level (LOEL) is 7.07 mg/kg/day (males) and
9.24 mg/kg/day (females).  No statistically significant, linear dose
response was observed for any tumor incidence.  A 104-week combined
carcinogenicity study in mice was conducted with mice administered
fenamidone in the diet at dose levels of 0, 9.5, 47.5, 525.5, 1100.2
mg/kg/day (males) and 0, 12.6, 63.8, 690.5, 1393.2 mg/kg/day (females).
The NOEL was 9.5 mg/kg/day (males) and 12.6 mg/kg/day (females).  The
LOEL for carcinogenicity was 47.5 mg/kg/day (males) and 63.8 mg/kg/day
(females).  The NOEL is based on non-neoplastic liver changes and
decreased body weight gain at the top two dose levels.  Fenamidone
demonstrates no potential for carcinogenic effects in mammals.]

.  [Metabolism studies conducted with goat and hen demonstrate that
fenamidone is rapidly metabolized and excreted.  Residue levels in
edible animal tissues (meat, milk and eggs) are negligible and do
accumulate in those tissues.  The metabolic pathway proceeds via
cleavage of the amino-phenyl group and the thiomethyl group with further
metabolism by hydroxylation.  There is also evidence to that glucuronide
and sulfate conjugates are formed.  A single low dose (3 mg/kg), a
single high dose (300 mg/kg) and a low dose (3 mg/kg) administered for
15 consecutive days were fed to rats.  Fenamidone was relatively well
absorbed at a nominal dose of 3 mg/kg in both sexes and intensively
metabolized by phase I (oxidation, reduction and hydrolysis) and II
(conjugation) reactions.  The elimination of radiolabeled fenamidone was
relatively rapid with the majority of the administered dose being
excreted via the biliary route (for the low dose experiments).  The
comparison of the levels of radioactivity recovered in bile kinetic and
ADME studies suggested that a part of the radioactivity excreted via the
bile could be reabsorbed and subsequently re-excreted via the urine.
High levels of radioactivity measured in blood samples from the tissue
kinetics also supported this hypothesis.  At the high dose level
fenamidone was not very well absorbed:  Some 50-60% of the radioactivity
was present as parent compound in the feces.  Radioactivity was widely
distributed in the tissues with predominance in the thyroids, blood,
liver, kidneys, fat and pancreas.  Fenamidone is therefore expected to
be rapidly and extensively metabolized and excreted in mammals.]

.  [The major dietary metabolites of fenamidone, RPA 412708, RPA 410193
and RPA 412636 were evaluated for mammalian toxicity in an acute oral
toxicity study, a 90-day repeated dose study and in genotoxicity tests.
The metabolites are considered to be of comparable toxicity to the
parent fenamidone.]

.  [Chronic, lifespan, and multi-generational bioassays in mammals and
acute and subchronic studies on aquatic organisms and wildlife did not
reveal endocrine effects.  Any endocrine related effects would have been
detected in this definitive array of required tests.  The probability of
any such effect due to agricultural uses of fenamidone is negligible.]

C. Aggregate Exposure

.  [Fenamidone is registered for use on head and leaf lettuce, tomatoes,
tuberous and corm vegetables (subgroup 1c), bulb vegetables (group 3),
cucurbit vegetables (group 9), including tolerances for rotational wheat
and imported wine grapes.  There are no residential uses proposed for
fenamidone.  New petitions have been submitted to the Agency for
fruiting vegetables (group 8),  brassica vegetables (group 5), leafy
vegetables (group 4), carrots, cotton, sunflowers (seed treatment), and
strawberries (rotational only).  Therefore the aggregate exposure would
consist of any potential exposures to fenamidone residues from carrots
plus the above food crops, drinking water, and imported wine.  The acute
reference dose (aRfD) of 0.92 mg/kg bw/day is based on a NOAEL of 92
mg/kg bw/day from the developmental neurotoxicity study in rat and the
standard 100X uncertainty factor (10X interspecies and 10X
intraspecies).  The chronic RfD (cRfD) of 0.03 mg/kg bw/day is based on
a NOAEL of 2.83 mg/kg bw/day from the two-year rat chronic study and the
UF of 100X.]

.  [Acute and chronic dietary analyses were conducted to estimate
exposure to potential fenamidone residues in/on the crops and crop
groups of tuberous and corm vegetables, leafy vegetables, bulb
vegetables, fruiting vegetables, cucurbit vegetables, brassica
vegetables, cotton, carrots, sunflower, and imported wine as well as
rotational strawberries.   Tier III analyses were conducted for both the
acute and chronic scenarios using the DEEM( (Exponent, Inc.) software.
The acute dietary exposure estimates at the 99.9th percentile of
exposure for the US Population was 2.2% of the acute Reference Dose
(aRfD).  The population subgroup with the highest exposure was Infants
at 7.3% of the aRfD.  Chronic dietary exposure estimates from potential
residues of fenamidone for the US Population was 2.2% of the chronic RfD
(cRfD).  The sub-population with the highest exposure was Children 1-2
at 4.2% of the cRfD.].

.  [US EPA’s Standard Operating Procedure (SOP) for Drinking Water
Exposure and Risk Assessments was used to perform the drinking water
assessment.  This SOP uses a variety of tools to conduct drinking water
assessments, including water models such as SCI-GROW, FIRST,
PRZMS/EXAMS, and available monitoring data.  If monitoring data are not
available, then the models are used to predict potential residues in
surface and ground water and the highest levels are assumed to be the
drinking water residue.  In the case of fenamidone, monitoring data do
not exist, therefore SCI-GROW and FIRST were used to estimate a water
residue.  The calculated drinking water levels of comparison (DWLOC) for
acute and chronic exposure for all adults and children exceed the
modeled drinking water estimated environmental concentration (EEC).  The
acute DWLOC values are 31504 ppb for the general population, 8530 ppb
for infants and 8789 ppb for children, compared to  the worst-case acute
drinking water EEC of 10.47 ppb.  The chronic DWLOC values are 957 ppb
for the general population, 268 ppb for infants and 275 ppb for children
1-2, compared to a worst-case chronic drinking water EEC of 8.2 ppb.
These drinking water levels of comparison are based on conservative
dietary (food) exposures and are typically expected to be much higher
under actual use scenarios.]

.  [Fenamidone is not registered for residential uses (food or
non-food), thereby eliminating any potential for residential exposure or
non-occupational exposure.]

D. Cumulative Effects

[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.  There is no available data to determine
whether fenamidone has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment.  Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
fenamidone does not appear to produce a toxic metabolite produced by
other substances.  For the purposes of this tolerance petition,
therefore, it has not been assumed that fenamidone has a common
mechanism of toxicity with other substances.]

E. Safety Determination

.  [In consideration of the toxicology database as discussed above, EPA
has determined that there is no extra sensitivity of infants and
children, and therefore the default FQPA safety factor can be removed.
Using the assumptions and data described in the exposure section above,
the percent of the aRfD and cRfD that will be used for exposure to
residues of fenamidone in food for infants and children (the most highly
exposed subgroups) is 7.3% (acute assessment for infants) and 4.2%
(chronic assessment for children 1-2), respectively. There are no
non-dietary concerns for infants and children.  As with adults, drinking
water levels of comparison are higher than the worst case drinking water
estimated concentrations and are expected to use well below 100% of the
reference dose, if they occur at all.  Therefore, there is a reasonable
certainty that no harm will occur to infants and children from aggregate
exposure to residues of fenamidone.]

F. International Tolerances

[Codex MRLs are not yet established for fenamidone.]

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