JJJ.......................  Petroleum Dry Cleaners...........               X                X                X
KKK.......................  Equipment Leaks of VOC From                     X                X   ...............
                             Onshore Natural Gas Processing
                             Plants.
LLL.......................  Onshore Natural Gas Processing:                 X                X   ...............
                             SO2 Emissions.
MMM.......................  (Reserved).......................  ...............  ...............  ...............
NNN.......................  Volatile Organic Compound (VOC)                 X                X   ...............
                             Emissions From Synthetic Organic
                             Chemical Manufacturing Industry
                             (SOCMI) Distillation Operations.
OOO.......................  Nonmetallic Mineral Processing                  X                X   ...............
                             Plants.
PPP.......................  Wool Fiberglass Insulation                      X                X   ...............
                             Manufacturing Plants.
QQQ.......................  VOC Emissions From Petroleum                    X                X   ...............
                             Refinery Wastewater Systems.
RRR.......................  Volatile Organic Compound                       X                X   ...............
                             Emissions from Synthetic Organic
                             Chemical Manufacturing Industry
                             (SOCMI) Reactor Processes.
SSS.......................  Magnetic Tape Coating Facilities.               X                X   ...............
TTT.......................  Industrial Surface Coating:                     X                X                X
                             Surface Coating of Plastic Parts
                             for Business Machines.
UUU.......................  Calciners and Dryers in Mineral                 X                X                X
                             Industries.
VVV.......................  Polymeric Coating of Supporting                 X                X                X
                             Substrates Facilities.
WWW.......................  Municipal Solid Waste Landfills..               X                X                X
AAAA......................  Small Municipal Waste Combustion                X                X                X
                             Units for Which Construction is
                             Commenced After August 30, 1999
                             or for Which Modification or
                             Reconstruction is Commended
                             After June 6, 2001.
CCCC......................  Commercial and Industrial Solid                 X                X                X
                             Waste Incineration Units for
                             Which Construction Is Commenced
                             After November 30, 1999 or for
                             Which Modification or
                             Reconstruction Is Commenced on
                             or After June 1, 2001.
EEEE......................  Other Solid Waste Incineration                  X                X                X
                             Units for Which Construction is
                             Commenced After December 9,
                             2004, or for Which Modification
                             or Reconstruction is Commenced
                             on or After June 16, 2006.
GGGG......................  (Reserved).......................  ...............  ...............  ...............
HHHH......................  (Reserved).......................  ...............  ...............  ...............
IIII......................  Stationary Compression Ignition                 X                X                X
                             Internal Combustion Engines.
JJJJ......................  Stationary Spark Ignition                       X                X                X
                             Internal Combustion Engines.

KKKK......................  Stationary Combustion Turbines...               X                X                X
LLLL......................  New Sewage Sludge Incineration     ...............               X   ...............
                             Units.
OOOO......................  Crude Oil and Natural Gas          ...............  ...............  ...............
                             Production, Transmission, and
                             Distribution.
----------------------------------------------------------------------------------------------------------------

* * * * *

PART 61--[AMENDED]

0
1. The authority citation for part 61 continues to read as follows:

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

Subpart A--General Provisions

0
2. Section 61.04 is amended by revising the table in paragraph
(c)(9)(i), and by revising the introductory paragraphs and tables in
(c)(9)(ii)(A), (c)(9)(ii)(E), and (c)(9)(iv) to read as follows:

Sec.  61.04  Address.

* * * * *
    (c) * * *
* * * * *
    (9) * * *
    (i) * * *

           Delegation Status for National Emission Standards for Hazardous Air Pollutants for Arizona
----------------------------------------------------------------------------------------------------------------
                                                                 Air pollution control agency
                             Subpart         -------------------------------------------------------------------
                                                Arizona DEQ    Maricopa County    Pima County      Pinal County
----------------------------------------------------------------------------------------------------------------
A.................  General Provisions......               X                X                X                X
B.................  Radon Emissions From      ...............  ...............  ...............  ...............
                     Underground Uranium
                     Mines.
C.................  Beryllium...............               X                X                X                X
D.................  Beryllium Rocket Motor                 X                X                X                X
                     Firing.
E.................  Mercury.................               X                X                X                X
F.................  Vinyl Chloride..........               X                X                X                X
G.................  (Reserved)..............  ...............  ...............  ...............  ...............
H.................  Emissions of              ...............  ...............  ...............  ...............
                     Radionuclides Other
                     Than Radon From
                     Department of Energy
                     Facilities.
I.................  Radionuclide Emissions    ...............  ...............  ...............  ...............
                     From Federal Facilities
                     Other Than Nuclear
                     Regulatory Commission
                     Licensees and Not
                     Covered by Subpart H.
J.................  Equipment Leaks                        X                X                X                X
                     (Fugitive Emission
                     Sources) of Benzene.
K.................  Radionuclide Emissions    ...............  ...............  ...............  ...............
                     From Elemental
                     Phosphorus Plants.
L.................  Benzene Emissions from                 X                X                X                X
                     Coke By-Product
                     Recovery Plants.
M.................  Asbestos................               X                X                X                X
N.................  Inorganic Arsenic                      X                X                X   ...............
                     Emissions From Glass
                     Manufacturing Plants.
O.................  Inorganic Arsenic                      X                X                X   ...............
                     Emissions From Primary
                     Copper Smelters.
P.................  Inorganic Arsenic                      X                X   ...............  ...............
                     Emissions From Arsenic
                     Trioxide and Metallic
                     Arsenic Production
                     Facilities.
Q.................  Radon Emissions From      ...............  ...............  ...............  ...............
                     Department of Energy
                     Facilities.
R.................  Radon Emissions From      ...............  ...............  ...............  ...............
                     Phosphogypsum Stacks.
S.................  (Reserved)..............  ...............  ...............  ...............  ...............
T.................  Radon Emissions From the  ...............  ...............  ...............  ...............
                     Disposal of Uranium
                     Mill Tailings.
U.................  (Reserved)..............  ...............  ...............  ...............  ...............
V.................  Equipment Leaks                        X                X                X                X
                     (Fugitive Emission
                     Sources).
W.................  Radon Emissions From      ...............  ...............  ...............  ...............
                     Operating Mill Tailings.
X.................  (Reserved)..............  ...............  ...............  ...............  ...............
Y.................  Benzene Emissions From                 X                X                X                X
                     Benzene Storage Vessels.
Z-AA..............  (Reserved)..............  ...............  ...............  ...............  ...............
BB................  Benzene Emissions From                 X                X                X                X
                     Benzene Transfer
                     Operations.
CC-EE.............  (Reserved)..............  ...............  ...............  ...............  ...............
FF................  Benzene Waste Operations               X                X                X                X
----------------------------------------------------------------------------------------------------------------

* * * * *
    (ii) * * *
    (A) Delegations for Amador County Air Pollution Control District,
Antelope Valley Air Quality Management District, Bay Area Air Quality
Management District, and Butte County Air Quality Management District
are shown in the following table:

Delegation Status for National Emissions Standards for Hazardous Air Pollutants for Amador County APCD, Antelope
                                Valley AQMD, Bay Area AQMD, and Butte County AQMD
----------------------------------------------------------------------------------------------------------------
                                                                 Air pollution control agency
                                             -------------------------------------------------------------------
                             Subpart           Amador County   Antelope Valley                     Butte County
                                                    APCD             AQMD        Bay Area AQMD         AQMD
----------------------------------------------------------------------------------------------------------------
A.................  General Provisions......  ...............               X                X   ...............
B.................  Radon Emissions From      ...............  ...............  ...............  ...............
                     Underground Uranium
                     Mines.
C.................  Beryllium...............  ...............               X                X   ...............
D.................  Beryllium Rocket Motor    ...............               X                X   ...............
                     Firing.
E.................  Mercury.................  ...............               X                X   ...............
F.................  Vinyl Chloride..........  ...............               X                X   ...............
G.................  (Reserved)..............  ...............  ...............  ...............  ...............
H.................  Emissions of              ...............  ...............  ...............  ...............
                     Radionuclides Other
                     Than Radon From
                     Department of Energy
                     Facilities.
I.................  Radionuclide Emissions    ...............  ...............  ...............  ...............
                     From Federal Facilities
                     Other Than Nuclear
                     Regulatory Commission
                     Licensees and Not
                     Covered by Subpart H.
J.................  Equipment Leaks           ...............               X   ...............  ...............
                     (Fugitive Emission
                     Sources) of Benzene.
K.................  Radionuclide Emissions    ...............  ...............  ...............  ...............
                     From Elemental
                     Phosphorus Plants.
L.................  Benzene Emissions from    ...............               X                X   ...............
                     Coke By-Product
                     Recovery Plants.
M.................  Asbestos................  ...............               X                X   ...............
N.................  Inorganic Arsenic         ...............               X   ...............  ...............
                     Emissions From Glass
                     Manufacturing Plants.
O.................  Inorganic Arsenic         ...............               X   ...............  ...............
                     Emissions From Primary
                     Copper Smelters.
P.................  Inorganic Arsenic         ...............               X   ...............  ...............
                     Emissions From Arsenic
                     Trioxide and Metallic
                     Arsenic Production
                     Facilities.
Q.................  Radon Emissions From      ...............  ...............  ...............  ...............
                     Department of Energy
                     Facilities.
R.................  Radon Emissions From      ...............  ...............  ...............  ...............
                     Phosphogypsum Stacks.
S.................  (Reserved)..............  ...............  ...............  ...............  ...............
T.................  Radon Emissions From the  ...............  ...............  ...............  ...............
                     Disposal of Uranium
                     Mill Tailings.
U.................  (Reserved)..............  ...............  ...............  ...............  ...............
V.................  Equipment Leaks           ...............               X   ...............  ...............
                     (Fugitive Emission
                     Sources).
W.................  Radon Emissions From      ...............  ...............  ...............  ...............
                     Operating Mill Tailings.
X.................  (Reserved)..............  ...............  ...............  ...............  ...............
Y.................  Benzene Emissions From    ...............               X                X   ...............
                     Benzene Storage Vessels.
Z-AA..............  (Reserved)..............  ...............  ...............  ...............  ...............
BB................  Benzene Emissions From    ...............               X                X   ...............
                     Benzene Transfer
                     Operations.
CC-EE.............  (Reserved)..............  ...............  ...............  ...............  ...............
FF................  Benzene Waste Operations  ...............               X                X   ...............
----------------------------------------------------------------------------------------------------------------

* * * * *
    (E) Delegations for Modoc Air Pollution Control District, Mojave
Desert Air Quality Management District, Monterey Bay Unified Air
Pollution Control District, and North Coast Unified Air Quality
Management District are shown in the following table:

  Delegation Status for National Emissions Standards for Hazardous Air Pollutants for Modoc County APCD, Mojave
                      Desert AQMD, Monterey Bay Unified APCD, and North Coast Unified AQMD
----------------------------------------------------------------------------------------------------------------
                                                                 Air pollution control agency
                                             -------------------------------------------------------------------
                             Subpart            Modoc County    Mojave Desert     Monterey Bay     North Coast
                                                    APCD             AQMD         Unified APCD     Unified AQMD
----------------------------------------------------------------------------------------------------------------
A.................  General Provisions......               X                X                X                X
B.................  Radon Emissions From      ...............  ...............  ...............  ...............
                     Underground Uranium
                     Mines.
C.................  Beryllium...............               X                X                X                X
D.................  Beryllium Rocket Motor                 X                X                X                X
                     Firing.
E.................  Mercury.................               X                X                X                X
F.................  Vinyl Chloride..........               X                X                X                X
G.................  (Reserved)..............  ...............  ...............  ...............  ...............
H.................  Emissions of              ...............  ...............  ...............  ...............
                     Radionuclides Other
                     Than Radon From
                     Department of Energy
                     Facilities.
I.................  Radionuclide Emissions    ...............  ...............  ...............  ...............
                     From Federal Facilities
                     Other Than Nuclear
                     Regulatory Commission
                     Licensees and Not
                     Covered by Subpart H.
J.................  Equipment Leaks                        X                X                X                X
                     (Fugitive Emission
                     Sources) of Benzene.
K.................  Radionuclide Emissions    ...............  ...............  ...............  ...............
                     From Elemental
                     Phosphorus Plants.
L.................  Benzene Emissions from    ...............               X                X                X
                     Coke By-Product
                     Recovery Plants.
M.................  Asbestos................               X                X                X                X
N.................  Inorganic Arsenic         ...............               X                X   ...............
                     Emissions From Glass
                     Manufacturing Plants.
O.................  Inorganic Arsenic                      X                X                X   ...............
                     Emissions From Primary
                     Copper Smelters.

P.................  Inorganic Arsenic                      X                X                X   ...............
                     Emissions From Arsenic
                     Trioxide and Metallic
                     Arsenic Production
                     Facilities.
Q.................  Radon Emissions From      ...............  ...............  ...............  ...............
                     Department of Energy
                     Facilities.
R.................  Radon Emissions From      ...............  ...............  ...............  ...............
                     Phosphogypsum Stacks.
S.................  (Reserved)..............  ...............  ...............  ...............  ...............
T.................  Radon Emissions From the  ...............  ...............  ...............  ...............
                     Disposal of Uranium
                     Mill Tailings.
U.................  (Reserved)..............  ...............  ...............  ...............  ...............
V.................  Equipment Leaks                        X                X                X                X
                     (Fugitive Emission
                     Sources).
W.................  Radon Emissions From      ...............  ...............  ...............  ...............
                     Operating Mill Tailings.
X.................  (Reserved)..............  ...............  ...............  ...............  ...............
Y.................  Benzene Emissions From    ...............               X                X                X
                     Benzene Storage Vessels.
Z-AA..............  (Reserved)..............  ...............  ...............  ...............  ...............
BB................  Benzene Emissions From    ...............               X                X   ...............
                     Benzene Transfer
                     Operations.
CC-EE.............  (Reserved)..............  ...............  ...............  ...............  ...............
FF................  Benzene Waste Operations  ...............               X                X   ...............
----------------------------------------------------------------------------------------------------------------

* * * * *
    (iv) Nevada. The following table identifies delegations for Nevada:

           Delegation Status for National Emissions Standards for Hazardous Air Pollutants for Nevada
----------------------------------------------------------------------------------------------------------------
                                                                          Air pollution control agency
                                         Subpart              --------------------------------------------------
                                                                  Nevada DEP      Clark County    Washoe County
----------------------------------------------------------------------------------------------------------------
A.........................  General Provisions...............               X                X   ...............
B.........................  Radon Emissions From Underground   ...............  ...............  ...............
                             Uranium Mines.
C.........................  Beryllium........................               X                X                X
D.........................  Beryllium Rocket Motor Firing....               X                X   ...............
E.........................  Mercury..........................               X                X   ...............
F.........................  Vinyl Chloride...................               X                X   ...............
G.........................  (Reserved).......................  ...............  ...............  ...............
H.........................  Emissions of Radionuclides Other                X   ...............  ...............
                             Than Radon From Department of
                             Energy Facilities.
I.........................  Radionuclide Emissions From                     X   ...............  ...............
                             Federal Facilities Other Than
                             Nuclear Regulatory Commission
                             Licensees and Not Covered by
                             Subpart H.
J.........................  Equipment Leaks (Fugitive                       X                X   ...............
                             Emission Sources) of Benzene.
K.........................  Radionuclide Emissions From                     X   ...............  ...............
                             Elemental Phosphorus Plants.
L.........................  Benzene Emissions from Coke By-                 X                X   ...............
                             Product Recovery Plants.
M.........................  Asbestos.........................  ...............               X                X
N.........................  Inorganic Arsenic Emissions From                X                X   ...............
                             Glass Manufacturing Plants.
O.........................  Inorganic Arsenic Emissions From                X                X   ...............
                             Primary Copper Smelters.
P.........................  Inorganic Arsenic Emissions From                X                X   ...............
                             Arsenic Trioxide and Metallic
                             Arsenic Production Facilities.
Q.........................  Radon Emissions From Department    ...............  ...............  ...............
                             of Energy Facilities.
R.........................  Radon Emissions From               ...............  ...............  ...............
                             Phosphogypsum Stacks.
S.........................  (Reserved).......................  ...............  ...............  ...............
T.........................  Radon Emissions From the Disposal  ...............  ...............  ...............
                             of Uranium Mill Tailings.
U.........................  (Reserved).......................  ...............  ...............  ...............
V.........................  Equipment Leaks (Fugitive                       X                X   ...............
                             Emission Sources).
W.........................  Radon Emissions From Operating     ...............  ...............  ...............
                             Mill Tailings.
X.........................  (Reserved).......................  ...............  ...............  ...............
Y.........................  Benzene Emissions From Benzene                  X                X   ...............
                             Storage Vessels.
Z-AA......................  (Reserved).......................  ...............  ...............  ...............
BB........................  Benzene Emissions From Benzene                  X                X   ...............
                             Transfer Operations.
CC-EE.....................  (Reserved).......................  ...............  ...............  ...............
FF........................  Benzene Waste Operations.........               X                X   ...............
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-10180 Filed 4-29-13; 8:45 am]
BILLING CODE 6560-50-P


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

EPA Registration Division contact: Andrew Ertman 703-308 - 9367

Interregional Research Project #4.

PP #0E7748

	EPA has received a pesticide petition (PP #0E7748) from IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.205 by establishing a tolerance for residues of paraquat dichloride in or on the raw agricultural commodities for the following perennial tropical and sub-tropical fruit trees: sugar apple, cherimoya, atemoya, custard apple, ilama, soursop, biriba, lychee, longan, Spanish lime, rambutan, pulasan, star apple, black sapote, mango, sapodilla, canistel, mamey sapote, feijoa, jaboticaba, wax jambu, starfruit (carambola), pawpaw, pomegranate, and white sapote at 0.05 parts per million (ppm).  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. The qualitative nature of the residue in plants is adequately understood based on studies depicting the metabolism of paraquat dichloride in carrots and lettuce following preemergence treatments and in potatoes and soybeans following desiccant treatment. The residue of concern in plants is the parent, paraquat dichloride; the current tolerance expression for plant commodities, as defined in 40 CFR 180.205(a) and (b).

	2. Analytical method. An adequate analytical method (spectrometric method) has been accepted and published in The Pesticide Analytical Manual (PAM Vol. II) for the enforcement of tolerances in plant commodities.

	3. Magnitude of residues. The proposed use pattern for the perennial tropical fruit crops is based upon the use pattern for the following currently labeled perennial crops: avocado, acerola, banana, papaya, guava,  coffee, tree nuts, fig, citrus fruit, pome fruit, olive, persimmon, and stone fruit, which all have a tolerance of 0.05 ppm.  As such, IR-4 is requesting tolerances and registrations be established on all perennial tropical fruit crops based on surrogate data and current registrations. Specifically, IR-4 requests 0.05 ppm tolerances and registrations for the following perennial tropical and semi-tropical fruit trees: sugar apple, cherimoya, atemoya, custard apple, ilama, soursop, birba, lychee, longan, Spanish lime, rambutan, pulasan, star apple, black sapote, mango, sapodilla, canistel, mamey sapote, feijoa, jaboticaba, wax jambu, starfruit (carambola), pawpaw, pomegranate, and white sapote.

B. Toxicological Profile The United States Environmental Protection Agency (EPA) has evaluated the available paraquat dichloride toxicological database and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the reliability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxicity profile of paraquat dichloride is discussed in the September 6, 2006 Federal Register publication of the Final Rule for establishing tolerances for residues of paraquat dichloride in or on various food and feed commodities [EPA - HQ - OPP - 2006 - 0664; FRL - 8089 - 3].

C. Aggregate Exposure

	1. Dietary exposure. Tier II acute and chronic risk assessments were performed for the herbicide paraquat (1,1′-dimethyl-4,4′-bipyridinium-ion) derived from application of either the bis(methyl sulfate) or the dichloride salt (both calculated as the cation) using the Dietary Exposure Evaluation Model (DEEM-FCIDTM, version 2.16) from Exponent.  In addition to the established tolerances for residues of paraquat listed in 40CFR180.205, these exposure assessments also included revised crop tolerances for a proposed new post-emergent use on tropical fruits (0.05 ppm) including sugar apple, cherimoya, atemoya, custard apple, ilama, soursop, birba, lychee, longan, Spanish lime, rambutan, pulasan, star apple, black sapote, mango, sapodilla, canistel, mamey sapote, feijoa, jaboticaba, wax jambu, starfruit (carambola), pawpaw, pomegranate and white sapote.  Tolerance-level residues were assumed for all meat, milk, and egg commodities.  The EPA's Biological and Economic Analysis Division (BEAD) maximum and average percent crop treated (%CT) estimates described in the most recent EPA exposure assessment for paraquat (DP Barcode D327805, July 31, 2006) were utilized in the acute and chronic exposure assessments, respectively.  For all crops where BEAD %CT estimates were unavailable, 100%CT was conservatively assumed.  Syngenta exposure assessors believe that a value of 0.1 ppb, the Limit of Quantitation (LOQ) of the analytical screening method is appropriate for use as the EDWC for both acute and chronic assessments.  All consumption data for these assessments was taken from the USDA's Continuing Survey of Food Intake by individuals (CSFII) with the 1994-96 consumption database and the Supplemental CSFII children's survey (1998) consumption database.

	i. Food. Acute Exposure. The acute dietary (food only) risk assessment for females 13 to 49 years old was performed using an acute reference dose (aRfD) of 0.0042 mg/kg-bw/day, based upon a multigenerational study in rats with a no observable adverse effect level (NOAEL) of 1.25 mg/kg/day and an uncertainty factor (UF) of 100X for intra- and inter-species variations; an additional FQPA safety factor of 3X was applied for females between the ages of 13 and 49 years due to a data gap for a prenatal developmental study (UF=300X).  The acute dietary risk assessment for the general population and all other subgroups was performed using an aRfD of 0.0125 mg/kg-bw/day based upon the same NOAEL of 1.25 mg/kg/day and a UF of 100X for 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.  In addition, exposure was also expressed as a percent of the acute reference dose (% aRfD).  It should be noted that the most recent EPA acute exposure assessment for paraquat dichloride was based on a probabilistic Monte Carlo analysis using tolerance residue values. The current Syngenta acute assessment that is the subject of this petition was performed deterministically using tolerance residue values.  At the 99.9th percentile, acute (food only) exposure to the U.S. population resulted in a MOE of 393 (25.4% of the aRfD of 0.0125 mg/kg-bw/day).  The most exposed sub-population was children 1-2 years old, with a MOE of 261 (38.2% of the aRfD of 0.0125 mg/kg-bw/day).

Chronic Exposure. The paraquat chronic dietary (food only) risk assessment was performed for all population subgroups using a chronic reference dose (cRfD) of 0.0045 mg/kg-bw/day, based upon a chronic toxicity study in dogs with a no observable adverse effect level (NOAEL) of 0.45 mg/kg/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 only) exposure to the U.S. population resulted in a MOE of 1,510 (6.6% of the cRfD of 0.0045 mg/kg-bw/day).  The most exposed sub-population was children 1-2 years old with a MOE of 428 (23.3% of the cRfD of 0.0045 mg/kg-bw/day).

Cancer. Paraquat has been classified as a Group E chemical (no evidence of human carcinogenic potential).  Therefore, no cancer risk assessment was performed.

	ii. Drinking water. Syngenta exposure assessors believe that a value of 0.1 ppb, the Limit of Quantitation (LOQ) in the screening analytical method for paraquat in water, is appropriate for use as the estimated drinking water concentration (EDWCs) for paraquat dichloride.  Paraquat dichloride exhibits strong cation-exchange sorption to soils, thus current screening models are not appropriate for use in predicting EDWCs of the herbicide.  In most circumstances the levels of paraquat dichloride in surface or ground water are expected to be insignificant.  In the unlikely event that paraquat dichloride residues reached surface water bodies, they would be expected to be removed by sedimentation, coagulation, and flocculation processes in water treatment plants.  Therefore, residues of paraquat dichloride in drinking water derived from surface supplies can be assumed to be negligible.  Due to its extremely low mobility and strong tendency to bind tightly to soils, paraquat dichloride contamination of drinking water supplies derived from groundwater is expected to be highly unlikely.  Given these rationale, and since the proposed use parameters of paraquat dichloride on the perennial tropical fruit crops (sugar apple, cherimoya, atemoya, custard apple, ilama, soursop, birba, lychee, longan, Spanish lime, rambutan, pulasan, star apple, black sapote, mango, sapodilla, canistel, mamey sapote, feijoa, jaboticaba, wax jambu, starfruit (carambola), pawpaw, pomegranate, and white sapote) does not exceed currently labeled application and use parameters, Syngenta exposure assessors believe that the 0.1 ppb LOQ value is appropriate for use as the EDWC for both acute and chronic exposure assessments, and is protective for any surface or ground water concentration concerns.

Acute Exposure from Drinking Water:  The full method LOQ of 0.1 ppb (0.0001 ppm) was used as the acute EDWC and was incorporated with food residues as "water, direct and indirect, all sources" directly into the DEEM-FCID(TM) software to obtain acute dietary (food and water) exposures.  At the 99.9th percentile, acute (food and water) exposure to paraquat for the U.S. population resulted in a MOE of >1,000,000 (0.0% of the aRfD of 0.0125 mg/kg-bw/day).  The most exposed sub-population was children 3-5 years old, with a MOE of 62,500 (0.2% of the aRfD of 0.0125 mg/kg-bw/day).

Chronic Exposure from Drinking Water.  The full method LOQ of 0.1 ppb (0.0001 ppm) was used as the chronic EDWC and was incorporated with food residues as "water, direct and indirect, all sources" directly into the DEEM-FCID(TM) software to obtain chronic dietary (food and water) exposures.  Chronic exposure (food and water) to the U.S. population resulted in a MOE of 213,497 (0.0% of the cRfD of 0.0045 mg/kg-bw/day).  The most exposed sub-population was all infants (<1 year old), with a MOE of 65,120 (0.2% of the cRfD of 0.0045 mg/kg-bw/day).

Cancer.  Paraquat has been classified as a Group E chemical (no evidence of human carcinogenic potential).  Therefore, no cancer risk assessment was performed.

2.  Non-Dietary Exposure:  Paraquat dichloride is not registered for use on any sites that would result in residential exposure.

D. Cumulative Effects

	Cumulative Exposure to Substances with a Common Mechanism of Toxicity.  Section 408(b)(2)(D)(v) of FFDCA 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."  Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to paraquat and any other substances and paraquat does not appear to produce a toxic metabolite produced by other substances.  For the purposes of this tolerance action, the EPA has not assumed that paraquat has a common mechanism of toxicity with other substances.

E. Safety Determination

	1. U.S. population. The acute dietary exposure analysis (food plus water) showed that exposure from all established and proposed paraquat tolerances would result in a MOE of 394 (25.3 % of the aRfD of 0.0125 mg/kg-bw/day) for the U.S. population, which exceeds the Benchmark MOE of 100.  The chronic dietary exposure analysis (food plus water) showed that exposure from all established and proposed paraquat tolerances resulted in a MOE of 1,510 (6.6% of the cRfD of 0.0045 mg/kg-bw/day) for the U.S. population, which exceeds the Benchmark MOE of 100.  A chronic cancer exposure analysis was not performed, since there is no evidence of human carcinogenic potential for paraquat.  Short-term aggregate and intermediate-term aggregate risk was not assessed because there are no current, pending, or proposed residential uses for paraquat.

	2. Infants and children. The acute dietary exposure analysis (food plus water) showed that exposure from all established and proposed paraquat tolerances would result in a MOE of 261 (38.3 % of the aRfD of 0.0125 mg/kg-bw/day) for children 1-2 years old, which exceeds the Benchmark MOE of 100.  The chronic dietary exposure analysis (food plus water) showed that exposure from all established and proposed paraquat tolerances resulted in a MOE of 428 (23.4% of the cRfD of 0.0045 mg/kg-bw/day) for children 1-2 years old, which exceeds the Benchmark MOE of 100.  A chronic cancer exposure analysis was not performed, since there is no evidence of human carcinogenic potential for paraquat.  Short-term aggregate and intermediate-term aggregate risk was not assessed because there are no current, pending, or proposed residential uses for paraquat.

      3. Females 13-49 years of age.  The acute dietary exposure analysis (food plus water) showed that exposure from all established and proposed paraquat tolerances would result in a MOE of 867 (34.3% of the aRfD of 0.0042 mg/kg-bw/day) for females 13-49 years old, which exceeds the Benchmark MOE of 300.  The chronic dietary exposure analysis (food plus water) showed that exposure from all established and proposed paraquat tolerances resulted in a MOE of 2,232 (4.5% of the cRfD of 0.0045 mg/kg-bw/day) for females 13-49 years old, which exceeds the Benchmark MOE of 100.  A chronic cancer exposure analysis was not performed, since there is no evidence of human carcinogenic potential for paraquat.  Short-term aggregate and intermediate-term aggregate risk was not assessed because there are no current, pending, or proposed residential uses for paraquat.

F. International Tolerances

	Compatibility between U.S. tolerances and Codex Maximum Residue Levels (MRLs) exist for eggs, milk, ruminant tissues, passion fruit, sunflower seed and vegetables including beans (succulent), Brassica (cole) leafy vegetables group, carrots, cassava, corn (sweet), cucurbits, fruiting vegetables, lettuce, onions (dry bulb and green), peas (succulent), pigeon peas, turnips (roots and tops), and yams. Incompatibilities of U.S. tolerances and Codex MRLs on the following raw plant commodities remain because of differences in agricultural practices: Cottonseed, dry hops, dry peas/beans, maize, olives, potatoes, rice, sorghum, soybeans and wheat. No questions of compatibility exist with respect to commodities where no Codex MRLs have been established but United States tolerances exist or where Codex MRLs have been established but U.S. tolerances do not exist.


[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Pages 83555-83556]
[FR Doc No: 2023-26303]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2022-E-2198; FDA-2022-E-2202; FDA-2022-E-2203; and
FDA-2022-E-2204]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Ukoniq

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for Ukoniq and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by January 29, 2024.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by May 28, 2024. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 29, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2022-E-2198; FDA-2022-E-2202; FDA-2022-E-2203; and FDA-2022-E-2204
for ``Determination of Regulatory Review Period for Purposes of Patent
Extension; UKONIQ.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you

must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with Sec.  10.20 (21 CFR 10.20) and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, Ukoniq
(umbralisib tosylate) indicated for the treatment of adult patients
with:
     Relapsed or refractory marginal zone lymphoma who have
received at least one prior anti-CD20-based regimen.
     Relapsed or refractory follicular lymphoma who have
received at least three prior lines of systemic therapy.
    Subsequent to this approval, the USPTO received patent term
restoration applications for Ukoniq (U.S. Patent Nos. 9,150,579;
9,669,033; 10,072,013; and 10,570,142) from Rhizen Pharmaceuticals SA,
and the USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated September
21, 2022, FDA advised the USPTO that this human drug product had
undergone a regulatory review period and that the approval of Ukoniq
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
Ukoniq is 2,963 days. Of this time, 2,727 days occurred during the
testing phase of the regulatory review period, while 236 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
December 28, 2012. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
December 28, 2012.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: June 15,
2020. FDA has verified the applicant's claim that the new drug
application (NDA) for Ukoniq (NDA 213176) was initially submitted on
June 15, 2020.
    3. The date the application was approved: February 5, 2021. FDA has
verified the applicant's claim that NDA 213176 was approved on February
5, 2021.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 291 days, 577 days, or 583 days of patent term
extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26303 Filed 11-29-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 27, 2006 (Volume 71, Number 248)]
[Rules and Regulations]
[Page 77620-77625]
[DOCID:fr27de06-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0788; FRL-8108-8]

Fluthiacet-methyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues
of fluthiacet-methyl in or on cotton, gin byproducts and cotton,
undelinted seed. K-I Chemical U.S.A. Inc. requested this tolerance
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective December 27, 2006. Objections and
requests for hearings must be received on or before February 26, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:  EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0788. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

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:
     Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
    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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0788 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before February 26, 2007.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0788, by one of the following methods:
     Federal e Rule making Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of September 20, 2006 (71 FR 54987) (FRL-
8094-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F4821) by K-I Chemical U.S.A. Inc., 11 Martine Avenue, Suite 970,
White Plains, NY 10606. The petition requested that 40 CFR 180.551 be
amended by establishing a tolerance for combined residues of the
herbicide, fluthiacet-methyl, acetic acid, [[2-chloro-4-fluoro-5-
[(tetrahydro-3-oxo-1H,3H-[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-
ylidene)amino]phenyl]thio]-methyl ester, and its acid metabolite,
acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro-3-oxo-1H,3H-
[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-ylidene)amino]phenyl]thio]-,
in or on the food/feed commodities: Cotton, gin byproducts at 0.20 part
per million (ppm) and cotton, undelinted seed at 0.020 ppm. That notice
included a summary of the petition prepared by K-I Chemical U.S.A.
Inc., the registrant. There were no comments received in response to
the notice of filing.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/
[fxsp0]EPA-PEST/1997/November/[fxsp0]Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for combined residues of
fluthiacet-methyl in or on cotton, gin byproducts at 0.20 ppm and
cotton, undelinted seed at 0.020 ppm. EPA's assessment of exposures and
risks

associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by fluthiacet-methyl as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in the
Federal Register of December 21, 2001 (66 FR 65839) (FRL-6806-7).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF or 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/fedrgstr/EPA-PEST/[fxsp0]1997/

November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for fluthiacet-methyl used
for human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of December 21, 2001 (66 FR 65839)
(FRL-6806-7).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.551) for the residues of fluthiacet-methyl, in
or on a variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from fluthiacet-methyl in
food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
fluthiacet-methyl; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
The following assumptions were made for the chronic exposure
assessments: Tolerance level residues were assumed and refined with
average values of current and projected percent crop treated (PCT)
estimates. Refined current PCT estimates for field corn, sweet corn and
soybeans were determined to be on average < 1% and at a maximum 1%; and
projected PCT estimates for cotton were determined to be on average 30%
and at a maximum 34%.
    iii. Cancer. The Hazard Identification Assessment Review Committee
classified fluthiacet-methyl as likely to be a human carcinogen.
    Chronic and cancer exposure assessement. Chronic and cancer
exposures were determined to be dietary from residues in raw
agricultural commodities derived from the use of fluthiacet-methyl for
defoliating cotton and from water. HED determined that dietary exposure
to residues of fluthiacet-methyl and it acid metabolite (CGA-300402) in
or on cotton gin byproducts at 0.20 ppm and in or on cotton undelinted
seed at 0.020 were anticipated from the proposed use-pattern. These
tolerance level exposures were used in the risk assessment. In
addition, Estimated Drinking Water Concentrations (EDWCs) were
determined by modeling (PRZM/EXAMS, Tier II) for California, the
highest found level of potential residues for chronic (0.19 [mu]g/L)
and for cancer (0.14 [mu]g)
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must pursuant
to section 408(f)(1) require that data be provided 5 years after the
tolerance is established, modified, or left in effect, demonstrating
that the levels in food are not above the levels anticipated. Following
the initial data submission, EPA is authorized to require similar data
on a time frame it deems appropriate. For the present action, EPA will
issue such data call-ins for information relating to anticipated
residues as are required by FFDCA section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Such data call-ins will be required to
be submitted no later than 5 years from the date of issuance of this
tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if the Agency can make the following findings: Condition 1,
that the data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
    The Agency used PCT information as follows: The assumptions of the
dietary exposure analysis were tolerance level residues, modified by
default processing factors and percent crop treated (PCT) data. The
resulting chronic and cancer dietary assessments were classified as
Tier 2 assessments and are considered to be partially refined.
    PCT information came from EPA's refined usage analysis. Refined
current PCT estimates for field corn, sweet corn and soybeans were
determined to be on average < 1%, and at a maximum 1%. Projected PCT
estimates for cotton were

determined to be on average, 30%, and at a maximum 34%. Because the
estimated average PCTs for field corn, sweet corn and soybeans were
less than 1%, they were rounded up to 1% for use in the chronic and
cancer dietary assessments. The estimated average PCT for cotton was
used for both the chronic and cancer assessment. There were no data on
pop corn; therefore, 100% crop treated defaults were used. Default DEEM
7.81 processing factors were applied to corn, field, syrup and corn,
field, syrup-babyfood. EPA concluded that residues of fluthiacet-methyl
and its acid metabolite CGA-300403, were not expected to accumulate in
livestock tissues; therefore, livestock commodities were not factored
into the dietary risk assessment.
    The Agency believes that the three conditions listed in Unit
IV.C.1. have been met. With respect to Condition 1, PCT estimates are
derived from Federal and private market survey data, which are reliable
and have a valid basis. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions 2 and 3, regional consumption information and
consumption information for significant subpopulations are taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which fluthiacet-
methyl may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for fluthiacet-methyl in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of fluthiacet-methyl. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/[fxsp0]oppefed/models/water/index.htm.

    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System and Sreening Concentrations in Groundwater models, the estimated
environmental concentrations (EECs) of fluthiacet-methyl for acute
exposures are estimated to be between 0.23 and 1.0 parts per billion
(ppb) for surface water and 0.08 ppb for ground water. The EECs for
chronic and cancer exposures are estimated to be 0.19 and 0.l4,
respectively.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Fluthiacet-methyl is
not registered for use on any sites that would result in residential
exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to fluthiacet-methyl and any
other substances and fluthiacet-methyl does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that fluthiacet-methyl
has a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no quantitative or
qualitative evidence or increased susceptibility of rat and rabbit
fetuses to in utero exposure to fluthiacet-methyl in developmental
toxicity studies. There is no quantitative or qualitative evidence of
increased susceptibility to fluthiacet-methyl following prenatal/
postnatal exposure to a 2-generation reproduction study.
    3. Conclusion. EPA concluded based on reliable data that it would
be safe to remove the additional 10X safety factor for the protection
of infants and children. This conclusion was based on the following
findings:
    i. There is no quantitative or qualitative evidence of increased
susceptibility to fluthiacet-methyl following prenatal/postnatal
exposure;
    ii. There is no concern for developmental neurotoxicity resulting
from exposure to fluthiacet-methyl. A developmental neurotoxicity study
is not required;
    iii. The toxicological data base is complete for FQPA assessment;
    iv. The chronic dietary food exposure assessment utilizes tolerance
level residues and 34% of cotton and 1% corn and soybean crop treated
information for all commodities. By using these screening-level residue
values and conservative percent crop treated assessment, actual
exposures/risks will not be underestimated; and
    v. The dietary drinking water assessment utilizes water
concentration values generated by model and associated modeling
parameters that are designed to provide conservative, health
protective, high-end estimates of water concentrations that will not
likely be exceeded.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An effect of concern attributable to a single
exposure (dose)

was not identified from the oral toxicity studies including the
developmental toxicity studies in rat and rabbits. No acute risk is
expected from exposure to fluthiacet-methyl.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
fluthiacet-methyl from food will utilize < 1% of the cPAD for the U.S.
population, 1.4% of the cPAD for all infant < 1 year old. There are no
residential uses for fluthiacet-methyl that results in chronic
residential exposure to fluthiacet-methyl.
    3. Short-term risk. Fluthiacet-methyl is not registered for use on
any sites that would result in residential exposure. Therefore, the
aggregate risk is the sum of the risk from food and water, which do not
exceed the Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. The overall cancer
dietary risk for the U.S. population is 7.51 x 10-7, based
on dietary (food and drinking water exposures).
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to fluthiacet-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/mass
spectrometry method which uses negative ion chemical ionization (GC/
NCI-MS) is available to enforce the tolerance expression. The method
may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

B. International Residue Limits

    There are no Codex, Canadian or Mexican maximum residue limits
established for fluthiacet-methyl on corn, cotton and soybean
commodities or on meat and milk commodities.

V. Conclusion

    Therefore, the tolerance is established for combined residues of
Fluthiacet-methyl, acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro-3-
oxo-1H,3H-[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-
ylidene)amino]phenyl]thio]-methyl ester, and its acid metabolite,
acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro-3-oxo-1H,3H-
[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-ylidene)amino]phenyl]thio]-,
in or on cotton, gin byproducts at 0.20 ppm and cotton, undelinted seed
at 0.020 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects 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.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, 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, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final

rule in the Federal Register. This final rule is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: December 19, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.551 is amended by redesignating existing paragraph (a)
as (a)(1), and adding paragraph (a)(2) to read as follows.

Sec.  180.551  Fluthiacet-methyl; tolerances for residues.

    (a) General. (1) * * *
    (2) A tolerance is established for the combined residues of the
herbicide fluthiacet-methyland its acid metabolite: acetic acid, [[2-
chloro-4-fluoro-5-[tetrahydro-3-oxo-1H,3H-[1,3,4]thiadiazolo[3,4-
[alpha]]pyridazin-1-ylidene)amino]phenyl]thio]-methyl ester, and its
acid metabolite, acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro-3-oxo-
1H,3H-[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-
ylidene)amino]phenyl]thio]- , in or on the following food commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cotton, gin byproducts.....................................         0.20
Cotton undelinted seed.....................................        0.020
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-22126 Filed 12-26-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 83, Number 131 (Monday, July 9, 2018)]
[Notices]
[Page 31827]
[FR Doc No: 2018-14654]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Form SE, SEC File No. 270-289, OMB Control No. 3235-0327

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form SE (17 CFR 239.64) is used by registrants to file paper copies
of exhibits, reports or other documents that would be difficult or
impossible to submit electronically, as provided in Rule 311 of
Regulation S-T (17 CFR 232.311). The information contained in Form SE
is used by the Commission to identify paper copies of exhibits. Form SE
is filed by individuals, companies or other entities that are required
to file documents electronically. Approximately 19 registrants file
Form SE and it takes an estimated 0.10 hours per response for a total
annual burden of 2 hours (0.10 hours per response x 19 responses).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An 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 control number.
    Please direct your written comment to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Candace
Kenner, 100 F Street NE, Washington, DC 20549 or send an email to:
[email protected].

    Dated: July 3, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-14654 Filed 7-6-18; 8:45 am]
 BILLING CODE 8011-01-P