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

EPA Registration Division Contact: Kathryn Montague<PHONE_NUMBER>

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.

TEMPLATE:

[K-I CHEMICAL U.S.A., INC.]

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from
K-I CHEMICAL U.S.A., INC. c/o Landis International, Inc., P. O. Box 5126
Valdosta, GA  31603-5126 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 180.659 by establishing  tolerances for residues of
the herbicide pyroxasulfone
(3-[(5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)
pyrazole-4-ylmethylsulfonyl]-4,5-dihydro-5,5-dimethyl-1,2-oxazole) and
its metabolites in or on dried shelled peas and beans (crop subgroup 6C)
at 0.15 ppm, pea hay at 0.4 ppm, pea vines at 0.2 ppm, cowpea hay at
0.07 ppm, cowpea forage at 3.0 ppm, flax at 0.07 ppm, peanut at 0.2 ppm,
and peanut hay at 3 ppm, peanut meal at 0.40 ppm, vegetable, foliage of
legume, except soybean, subgroup 07A at 3.0 ppm.  The LC/MS/MS has been
proposed to enforce the tolerance expression for pyroxasulfone. 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.

Residue Chemistry

1. Plant Metabolism. Plant metabolism studies were conducted and
accepted by the Agency for soybean and field corn.  A potato metabolism
is being submitted at this time. The plant and animal metabolism of
pyroxasulfone is well understood. Primary metabolic processes are
cleavage between the two ring structures, side chain oxidation to
carboxylic acid and demethylation.  Pyroxasulfone and its major
metabolites M-1, M-3, M-25, and M-28 have been identified in the
metabolism studies. The metabolism of pyroxasulfone in plants and
animals is understood for the purposes of the proposed tolerances.
Pyroxasulfone and its metabolites M-3 and M-28 are the residues of
concern for tolerance setting purposes for crop subgroup 6C.
Pyroxasulfone only contains the residues of concern for tolerance
setting purposes for flax. Pyroxasulfone and its metabolites M-1, M-3,
M-25 and M-28 are the residues of concern for tolerance setting purposes
for peanut.

	2. Analytical method. EPA has approved an analytical enforcement
methodology including liquid chromatography, mass spectrometry, and mass
spectrometry (LC/MS/MS) to enforce the tolerance expression for
pyroxasulfone.

	3. Magnitude of residues.

Crop Subgroup 6C

A total of 26 dry edible bean and pea residue raw agricultural commodity
(RAC) field trials were conducted representing typical plus crop growing
regions in US and Canada. Bean trials were conducted in regions 5, 7,
7A, 8, 9, 10, 11, and 14. Successful cowpea trials were conducted in
regions 5 and 7. Pea trials were conducted in regions 5, 7, 11 and 14.
All applications were made according to the protocol.  Extraction
methods included extraction into aqueous acetonitrile followed by
clean-up steps. Analysis was conducted by LC-MS/MS. The proposed
tolerances were calculated using the OECD residue calculator. The
registrant proposes the following tolerances for pyroxasulfone
(3-[(5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)
pyrazole-4-ylmethylsulfonyl]-4,5-dihydro-5,5-dimethyl-1,2-oxazole) and
its metabolites in or on dried shelled peas and beans (crop subgroup 6C)
at 0.15 ppm, pea hay at 0.4 ppm, pea vines at 0.2 ppm, cowpea hay at
0.07 ppm, cowpea forage at 3.0 ppm, and vegetable, foliage of legume,
except soybean, subgroup 07A at 3.0 ppm.

Flax

	A total of 10 flax trials treated with pyroxasulfone were conducted
representing major commercial flax regions in the US and Canada. Flax
trials were conducted in regions 5, 7, and 14. Extraction methods
included extraction into aqueous acetonitrile followed by various
clean-up steps, depending on the analyte and matrix. Analytical methods
were validated for pyroxasulfone, M-1, M-3, M-25 and M-28 in flax seed,
meal and oil with analysis by LC-MS/MS. A tolerance for pyroxasulfone
and its metabolites on flax at 0.07 ppm is being proposed according to
the OECD MRL calculator.

Peanut

	A total of 13 peanut trials treated with pyroxasulfone were conducted
representing typical peanut growing regions in the US. Of the thirteen
trial sites, two sites included processed commodity components and three
sites included residue decline components. The trails were conducted in
regions 2, 3, 6 and 8. All applications were made according to the
protocol (one pre-ermergence or one post-emergence) by broadcast spray.
Extraction methods included extraction into aqueous acetonitrile
followed by various clean-up steps, depending on the analyte and matrix.
Analysis was by LCMS/MS. The LOQ for each analyte was 0.01 ppm.
Tolerances for pyroxasulfone and its metabolites on peanut at 0.2 ppm,
peanut hay at 3 ppm, and peanut meal at 0.40 ppm are being proposed
according to the OECD MRL calculator and the results of the processing
studies.

 Confined Rotational Crop Study

Pyrazole or isoxazoline ring labeled 14C KIH-485 was sprayed on confined
plots of bare soil prior to planting soybean, radish and wheat at 30,
120 and 365 day intervals.  There were two treated plots for each
plantback interval, one of which was wheat only and the other was
planted half with soybean and half with radish.  All plots were treated
at a target application rate of 300 g a.i./ha but the actual rate was
313 g a.i./ha.  Samples were analyzed by combustion analysis and liquid
scintillation counting.  All treated crops contained radioactive residue
>0.01 ppm and were subjected to further analysis.  The highest total
radioactive residue (TRR), 5.2 ppm was found at the 30 day rotational in
wheat straw; the residue level declined to 0.02 ppm at 485 days.  The
primary metabolites were M-1 and M-3.

Field Rotational Crop Study

A field rotational crop study was conducted in Georgia (GA) and Texas
(TX) on a fine and coarse textured soil, respectively. The purpose of
the study was to obtain raw agricultural commodity (RAC) residue data
for pyroxasulfone and its metabolites M-1, M-3, M-25, M-28, and M-37 on
rotational crops that are planted in plots that have been treated with
Pyroxasulfone 85 WG at the proposed label rate and aged for various time
intervals prior to planting the rotational plot. Each plot was treated
at an appropriate time for growing the target crop and then allowed to
age for the specified aging interval (120, 270, 300 and 365 days,
nominal intervals).  There was no residue seen in any crop matrix at any
sampling interval above the LOQ except for one replicate 120 day potato
top sample which showed residue of M-1 at the LOQ (0.01 ppm).    As a
result, neither pyroxasulfone nor any of its metabolites are expected to
accumulate in rotational crops when Pyroxasulfone 85 WG is applied to
target crops at the labeled rates.

Cow Feeding Study

	Holstein dairy cows were treated orally with gelatin capsules fortified
with pyroxasulfone.  These were administered once daily for 28
consecutive days at dose levels of 0, 1.8, 5.4, and 18 ppm per cow/day
on a dry weight basis amounting to concentrations of control, 1X, 3X and
10X dose groups, respectively.  These dose levels were equivalent to 0,
35.8 mg/cow/day, 109.9 mg/cow/day and 367.4 mg/cow/day, respectively.
Milk samples from the high dose animals (10X) were found to contain no
residues of the parent compound or metabolites with the exception of 3
milk samples from day 7 which contained an average of 0.003 ppm parent
pyroxasulfone.  No other milk samples from the other dose levels were
found to contain residues of pyroxasulfone or metabolites.  No other
matrix (muscle, liver, kidney or fat) was found to contain residues of
pyroxasulfone or metabolites above LOQ.  The LOQs were 0.001 ppm in milk
and 0.01 ppm in all other matrices.  Therefore, no tolerances for
residues of pyroxasulfone and its metabolites are being proposed for
meat, milk, eggs or other edible tissues of livestock or poultry.

B. Toxicological Profile

1.  Acute Toxicity. Pyroxasulfone was found to be of low acute toxicity
via oral, dermal and inhalation routes of administration.  It was not
irritating to skin or eyes and was not a sensitizing agent.  The
formulated product (85WG) was also of low acute toxicity and was found
to be mildly irritating to skin, moderately irritating to eyes and was a
dermal sensitizer.  In an acute neurotoxicity study in rats, there were
no test substance-related effects on body weights, food consumption,
clinical observations, functional observational battery assessments,
motor activity measurements, or gross and microscopic neuropathology.
The NOEL was demonstrated to be >2000 mg/kg/day in adult male and female
rats.

2.  Genotoxicity. Pyroxasulfone and its metabolites and impurities do
not induce gene mutations in bacterial cells.  Pyroxasulfone does not
induce gene mutations or chromosomal aberrations in in vitro mammalian
cells or in vivo in the mouse micronucleus test.  Pyroxasulfone is
non-genotoxic.

3.  Reproductive and developmental toxicity. In a developmental toxicity
study in rats, the NOEL for maternal and developmental toxicity was
>1000 mg/kg/day, the highest dose tested.

	In a developmental toxicity study in rabbits, there were slight test
substance-related effects on fetal weight and number of implant
resorptions at 1000 mg/kg/day, the highest dose tested.  The NOEL for
maternal toxicity was 1000 mg/kg/day. The NOEL for developmental
toxicity was 500 mg/kg/day.

	In a rat one-generation reproductive study no reproductive toxicity was
observed up to and including the high dose of 5000 ppm.  The NOEL for
reproductive toxicity was >5000 ppm, the highest dose tested.  The NOEL
for P1 adult rats was 25 ppm.  The NOEL for F1 offspring was 250 ppm and
the NOEL for F1 adults was 250 ppm.

	In a rat two-generation reproduction study there were no test
substance-related effects for reproductive toxicity at 2000 ppm, the
highest concentration tested.   The NOEL for reproductive toxicity was
>2000 ppm, the highest concentration tested. Test substance-related
effects were observed at 2000 ppm in both adults and offspring.
Therefore, the NOAEL for systemic toxicity was demonstrated to be 100
ppm (6.94 – 11.76 mg/kg/day) in both parents and offspring.

	In a developmental neurotoxicity study conducted on pyroxasulfone in
mated female rats no reproductive effects were observed in the maternal
animals at 2000 ppm, the highest concentration tested. No effects were
observed on FOBs, auditory startle response habituation, pre-pulse
inhibition, learning and memory of offspring.  A slight (5%) decrease in
absolute brain weight at 900 mg/kg/day was present on PD 66, although no
effect was present when evaluated on a % body weight basis.  Based on
the effects observed in this study, the maternal and offspring systemic
NOAEL is 900 mg/kg/day. The NOEL for functional development was judged
to be 900 mg/kg/day. A NOEL for histomorphological development of the
brain of the offspring was judged to be 300 mg/kg/day.

	Two studies were performed to assess the availability of the test
substance to the pup.  These studies indicated that pyroxasulfone was
available in the milk to nursing pups.

	4.  Subchronic toxicity. Pyroxasulfone was evaluated in a 28-day
inhalation toxicity study in rats.  There were no test substance-related
effects.  The NOEL was >200 mg/m3, the highest dose tested.

	In a 28-day dermal toxicity study there was a test substance-related
increase in the incidence of minimal to mild cardiac myofiber
degeneration with inflammation observed in males and females dosed with
1000 mg/kg/day and cutaneous myofiber degeneration with inflammation
observed in the treated skin of males dosed with 1000 mg/kg/day.  The
NOEL was 100 mg/kg/day.

	Immunotoxicity was evaluated in rats and mice following dietary
exposure for 28 days.  There were no test substance related effects for
any of the immunotoxicity parameters examined.  In the rat, systemic
toxicity was limited to reductions in body weight and food consumption.
The NOEL for immunotoxicity was 7500 ppm (529 and 570 mg/kg in males and
females) and the NOEL for systemic effects was 250 ppm (18 and 19 mg/kg
in males and females).  In the mouse, the NOEL for immunotoxicity was
4000 ppm (633 mg/kg/day males: 791 mg/kg/day females) and the NOEL for
systemic effects was 400 ppm (61 mg/kg males: 77 mg/kg females).

	Pyroxasulfone was evaluated in 13-week oral toxicity studies in rats,
mice and dogs. In the 13 week mouse study, no test substance-related
effects on in-life and clinical pathology parameters were observed at
any level tested. Test substance-related effects at 2500 ppm were
limited to an increased incidence of minimal to mild chronic progressive
nephropathy in female mice and increased liver weight in males and
females fed 2500 ppm.  The NOEL was 250 ppm for female mice (51.2
mg/kg/day).  The NOEL for male mice was 2500 ppm (394.0 mg/kg/day).

	 In the 13 week rat study, a NOEL of 250 ppm for male and female rats
corresponded to mean daily intake values of 16.4 and 20.6 mg/kg/day in
males and females, respectively.  Test substance related effects were
increased cardiac myofiber degeneration with inflammation and diffuse
mucosal hyperplasia of the urinary bladder.  Increased liver weights and
centrilobular hypertrophy were also observed in 2500 ppm males and
females. In a second study evaluating recovery, full or partial recovery
was evident in all the above effects apart from kidney weights in
females with all microscopic findings in the liver, heart, muscle and
pancreas of 5000 ppm animals comparable to control rats indicating a
complete reversal of the treatment-related findings noted at the
terminal sacrifice.

	In an oral 90 day toxicity study in beagle dogs administered
pyroxasulfone in a capsule, the NOEL was 2.0 mg/kg. The only effects
noted were degeneration of muscle fiber of the musculature portion of
the diaphragm, hyperplasia of the satellite cell of the muscle and nerve
fiber degeneration of the sciatic nerve in one 10mg/kg/day group male
only.  In a second study dosed with 0 or 15 mg/kg of pyroxasulfone,
male dogs showed a decrease in body weight and histopathology similar to
the full study.

	Pyroxasulfone was evaluated in a subchronic 90 day neurotoxicity
dietary study in rats.  There were no effects on body weights, food
consumption, clinical observations, FOB assessments, motor activity
measurements, or gross and microscopic neuropathology. The NOEL was
>2500 ppm, the highest dose tested, for male and female rats
corresponding to mean daily intake values of 161.48 and 199.59 mg/kg/day
in males and females, respectively.

5.  Chronic toxicity. Chronic toxicity studies were conducted in the rat
and dog. In the rat one year chronic toxicity study test
substance-related effects occurred at 1000 ppm and above that included
reduced body weight parameters and microscopic findings in the liver
(centrilobular hepatocellular hypertrophy in males), heart (increased
cardiomyopathy in females) and urinary bladder (mucosal hyperplasia in
males and females) and urinary bladder hyperplasia considered to be
secondary to inflammation or irritation.  At 2000 ppm, these effects
were accompanied by increased clinical observations of red discharge
from the penis and associated red-stained cageboards as well as
increased liver and kidney weights. A slight increase in liver and
kidney weights was observed in the 2000 ppm male and female dietary
exposure groups. The NOEL is 50 ppm (2.22 and 3.12 mg/kg/day for males
and females, respectively).

	In a one-year dog study beagle dogs/sex/dose were administered capsules
containing 0.0, 0.2, 2.0 and 10.0 mg/kg/day.  Adverse test
article-related findings were limited to the 10.0 mg/kg/day group, the
highest dose tested and not all animals at the 10 mg/kg/day dosage had
clear test-article related abnormal observations.  Adverse changes in
the clinical pathology parameters were increases in creatine kinase,
aspartate aminotransferase and change in the pathology limited to the
sciatic nerve and spinal cord.  The NOAEL is 2.0 mg/kg/day.

	The carcinogenic potential of pyroxasulfone was evaluated in rats and
mice. The Agency has classified pyroxasulfone as “Not likely to be
carcinogenic to humans” at doses that do not cause crystals with
subsequent calculi formation resulting in cellular damage of the urinary
tract.

6.  Animal metabolism.  In the rat, pyroxasulfone is rapidly and
completely eliminated.  Between 80 to 90% of pyroxasulfone was
eliminated in the urine during the first 24 hours and elimination was
essentially complete after 48 to 72 hours.  Absorption was calculated
(bile and urine) at 76%.  Maximum plasma concentrations were achieved at
2 hours in the low and 11 hours in the high dose animals.  At 96 hours
only 7% of the low dose and <0.5% of the high dose was present in the
carcass demonstrating the near complete elimination of pyroxasulfone.
Of the radioactivity present in the animals, the highest levels were
seen in the liver and kidney.  The major metabolites were a carboxylated
(pyrazole ring methyl group) and cleavage products between the
isoxazoline and pyrazole ring structure with subsequent carboxylation.
The absorption, distribution, metabolism and elimination of
pyroxasulfone is unaffected by sex or treatment regimen.

	In a preliminary study in the dog, pyroxasulfone is rapidly eliminated
with 76.9% of radioactivity excreted within 24 hours.  Excretion is
approximately equal in urine and feces. The terminal half life was 89.58
hr and 40.80 hr in blood and plasma, respectively.  The feces were found
to contain only unchanged pyroxasulfone while no parent molecule was
found in the urine.  At 120 hr after dosing, the levels of radioactivity
in the tissues were highest in the liver and blood.

	In a preliminary mouse metabolism study, 73% of the applied dose of
pyroxasulfone was excreted in urine within 24 hours of dosing.
Pyroxasulfone was rapidly absorbed and distributed through the tissues
of the mouse but by 24 hours after dosing, radioactivity concentrations
in the majority of tissues were indistinguishable from background
levels.

	Metabolism studies in livestock and poultry (Nature of Residue Studies
with Goat and Hen) with repeated dose established that pyroxasulfone was
rapidly metabolized and excreted and that there was minimal transmittal
of residues of pyroxasulfone and its metabolites to meat or milk.  For
goats fed 10 ppm of radiolabeled pyroxasulfone, the highest residues
(TRR) were seen in liver and kidney.  In the hen, fed 10 ppm, the
highest residue was seen in liver and muscle.

7.  Metabolite toxicology. Three plant metabolites and three impurities
were evaluated in acute oral toxicity studies.  All six test substances
evaluated showed LD50’s >2000 mg/kg similar to the parent,
pyroxasulfone.  Two metabolites were further assessed in a 14 day
toxicity study in rats.  The NOEL for each of the metabolites was > 1000
mg/kg.  The same three metabolites and impurities were evaluated in a
bacterial gene mutation test with and without activation.  All test
substances were non-genotoxic.

8.  Endocrine disruption. Pyroxasulfone does not belong to a class of
chemicals known or suspected of having adverse effects on the endocrine
system.  There is no evidence that pyroxasulfone has any effect on
endocrine function in developmental, reproduction or developmental
neurotoxicity studies.  Furthermore, histological investigation of
endocrine organs in chronic dog, rat and mouse studies did not indicate
that the endocrine system is targeted by pyroxasulfone.

C. Aggregate Exposure

	1. Dietary exposure. It can be concluded with reasonable certainty that
residues of pyroxasulfone in food will not result in unacceptable levels
of human health risk. Using proposed tolerances for corn, soybean and
wheat, both the acute and chronic dietary exposure MOEs for the overall
US population and 25 population subgroups are above the EPA level of
concern.

	i. Food. Acute and chronic dietary exposure assessments were conducted
using a Tier I approach.  This Tier I assessment incorporated tolerance
level residues and 100% crop-treated in the DEEMTM (Dietary Exposure
Evaluation Model; Exponent, Inc., v.4.02) software system.  The acute
reference dose (aRfD) used was 1 mg/kg/day based on the most current
risk assessments conducted by the EPA for amending the corn tolerance
dated 22 May 2015 (DP Barcode D417422). The chronic toxicological
endpoint selected for assessment of risk following chronic dietary
exposure was 2 mg/kg/day based on the one-year chronic feeding dog study
with a NOEL of 2 mg/kg/day. The chronic reference dose (cRfD) was
determined to be 0.02 mg/kg/day assuming the cRfD is 1 percent of the
NOEL. Using proposed tolerances for corn, soybean, wheat, cotton, crop
subgroup 6C, flax and peanut, the acute and chronic dietary exposure
Margin of Exposure (MOEs) for the overall US population and 25
population subgroups are above the EPA level of concern. It can be
concluded with reasonable certainty that residues of pyroxasulfone in
food will not result in unacceptable levels of human health risk.

	ii. Drinking water. Based on the Pesticide Root Zone Model/Exposure
Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model
Ground Water (PRZM GW), the estimated drinking water concentrations
(EDWCs) of pyroxasulfone for acute exposure are estimated to be 17 ppb
for surface water and 210 ppb for ground water. EDWCs of pyroxasulfone
for chronic exposures for non-cancer assessments are estimated to be 3.2
ppb for surface water and 174 ppb for ground water. It can be concluded
with reasonable certainty that residues of pyroxasulfone in drinking
water will not result in unacceptable levels of human health risk.

	2. Non-dietary exposure.

	i. Occupational exposure Pyroxasulfone is a wettable granule
formulation to be applied corn, cotton, flax, peanut, pulse crops,
soybeans, wheat, and fallow land using groundboom or aerial spray
equipment. The potential exposures and associated risks for handlers
mixing, loading and applying pyroxasulfone and for workers re-entering
treated areas are based on the proposed label for Pyroxasulfone 85WG
Herbicide (pyroxasulfone 85% dry flowable formulation). The maximum
application rate is 0.27 lb ai/acre (flax, peanut, pulse crops).
Pyroxasulfone 85 WG may be applied preplant surface, preplant
incorporated, preemergence, early postemergence, postemergence layby, or
in the fall.

Short- and intermediate-term dermal and inhalation exposures are
predicted for occupational handlers mixing, loading, and applying
pyroxasulfone. Since pyroxasulfone-specific exposure data are not
available, handler scenarios were assessed using the EPA Occupational
Pesticide Handler Unit Exposure Surrogate Reference Table - Revised
September 2015. The occupational handler exposure and risk estimates for
pyroxasulfone are listed below.  The estimates are for flax as flax has
the highest application rate and is considered a high acreage crop.

Occupational Handler Exposure & Risk Estimates for Pyroxasulfone

Short- & Intermediate-Term Exposure	Unit Exposure1 (mg/lb ai handled)
Application Rate

(lb ai/A)	Units Treated2 (A/day)	Average Daily Dose3 (mg ai/kg bw/day)
Short- & Intermediate-Term MOE4

Mixer/Loader – Liquids – Open Loading for Aerial Application

Dermal	0.0516	0.27	1200	0.21	490

Inhalation	0.00179	0.27	1200	0.0071	280

Mixer/Loader – Liquids – Open Loading for Groundboom Application

Dermal	0.0516	0.27	200	0.034	2,900

Inhalation	0.00896	0.27	200	0.0060	340

Applicator – Liquids – Aerial

Dermal	0.00208	0.27	1200	0.0083	12,000

Inhalation	0.0000049	0.27	1200	0.000020	102,000

Applicator – Liquids – Groundboom

Dermal	0.0161	0.27	200	0.011	9,400

Inhalation	0.00471	0.27	200	0.00023	8,900

1 Unit Exposure (UE) = mg ai/lb ai handled from Occupational Pesticide
Handler Unit Exposure Surrogate Reference Table - Revised September
2015.  PPE = long-sleeve shirt, long pants, socks, shoes, gloves and PF5
respirator (latter for aerial mixer/loader only).

2 Units Treated taken from Science Advisory Council for Exposure,
Standard Operating Procedure 9.1, Standard Values for Daily Acres
Treated in Agriculture, Rev. 25, September 2001.

3 Average Daily Dose (ADD) = Unit Exposure x Application Rate x Units
Treated x Absorption Factor ÷ Body Weight (80 kg).  Dermal absorption
factor = 100%, inhalation absorption factor = 100%.

4 Margin of Exposure (MOE) = NOAEL (mg/kg/day) ÷ ADD (mg/kg/day);
NOAELdermal = 100 mg/kg/day, NOAELinhalation = 2.0 mg/kg/day for all
durations.

Short- and intermediate-term dermal exposures are predicted for
post-application exposure to workers performing typical agricultural
tasks.  Since pyroxasulfone-specific exposure data are not available,
post-application scenarios were assessed using   HYPERLINK
"http://www.epa.gov/pesticides/science/exposac-policy-3-march2013.pdf"
Science Advisory Council for Exposure (ExpoSAC) Policy 3 – Revised
March 2013 . The occupational post-application exposure and risk
estimates for pyroxasulfone are listed below.

Occupational Post-Application Exposure & Risk Estimates for
Pyroxasulfone

Short- & Intermediate-Term Exposure	Crop

Activity	Transfer Coefficient1 (cm2/hr)	Application Rate

(lb ai/A)	Average Daily Dose2 (mg ai/kg bw/day)	Short- &
Intermediate-Term MOE3

Dermal	Corn, Irrigation (hand set)	1900	0.21	0.11	880

Dermal	Cotton, Scouting	210	0.11	0.0066	15,000

Dermal	Flax, Scouting	1100	0.27	0.082	1,200

Dermal	Peanut, Weeding, Hand	70	0.27	0.0052	19,000

Dermal	Pulse (Dried Shelled Beans and Peas), Irrigation (hand set)	1900
0.27	0.14	700

Dermal	Soybeans, Scouting	1100	0.19	0.057	1,700

Dermal	Wheat, Scouting	1100	0.13	0.041	2,400

1 Transfer Coefficient from   HYPERLINK
"http://www.epa.gov/pesticides/science/exposac-policy-3-march2013.pdf"
Science Advisory Council for Exposure (ExpoSAC) Policy 3 – Revised
March 2013 .  PPE = long-sleeve shirt, long pants, socks, shoes.

3 Average Daily Dose (ADD) = Transfer Coefficient (TC) x Dislodgeable
Foliar Residue (DFR) x Duration * Absorption Factor ÷ Body Weight
(80 kg).  DFR = 25% * Application Rate, Duration = 8 hrs/day, Dermal
Absorption Factor = 100%.

4 Margin of Exposure (MOE) = NOAEL (mg/kg/day) ÷ ADD (mg/kg/day);
NOAELdermal = 100 mg/kg/day for all durations.

All occupational handler and post-application exposures from
agricultural applications of pyroxasulfone result in MOEs greater than
100 and therefore do not exceed HED’s level of concern.

	ii. Residential (Non-occupational) exposure and risk  There are no
proposed uses of pyroxasulfone which would lead to direct exposure to
residents, either through mixing, loading and application or due to post
application exposure; however, there are potential indirect
post-application exposures to adults and children due to drift onto
residential lawns from agricultural applications.  These indirect
post-application scenarios were assessed based on the proposed label for
Pyroxasulfone 85WG Herbicide (pyroxasulfone 85% dry flowable
formulation) using draft Residential Exposure Assessment Standard
Operating Procedures - Addenda 1: Consideration of Spray Drift (November
1, 2013). The greatest indirect residential exposure potential is from
aerial application to flax, peanuts, and pulse crops. The residential
post-application exposure and risk estimates for pyroxasulfone are
listed below.

Residential Exposure & Risk Estimates for Pyroxasulfone

Short- & Intermediate-Term Exposure	Lifestage	Drift Application Rate1
(lb ai/A)	Average Daily Dose2 (mg ai/kg bw/day)	Short- &
Intermediate-Term MOE3

High Contact Lawn

Dermal	Adult	0.050	0.019	5,400

Dermal	1 to <2 years	0.050	0.037	2,700

Hand-to Mouth

Incidental Oral	1 to <2 years	0.050	0.00076	130,000

Object-to-Mouth

Incidental Oral	1 to <2 years	0.050	0.000023	4,400,000

Soil Ingestion

Incidental Oral	1 to <2 years	0.050	0.0000017	59,000,000

1 Drift Application Rate (ARdrift)= Application Rate * Drift Factor.
Application rate = 0.27 lb ai/A.  Drift Factor = 0.257 from Exposure
Assessment Standard Operating Procedures - Addenda 1: Consideration of
Spray Drift (November 1, 2013)

3 Average Daily Dose (ADD) for each exposure scenario was calculated
using the algorithms in the Standard Operating Procedures for
Residential Pesticide Exposure Assessment: October 2012.  ARdrift was
used in place of application rate in exposure calculations.

3 Margin of Exposure (MOE) = NOAEL (mg/kg/day) ÷ ADD (mg/kg/day);
NOAELdermal = 100 mg/kg/day, NOAELincidental oral = 100 mg/kg/day for
all durations.

All adult and children’s exposures due to drift from agricultural
applications of pyroxasulfone result in MOEs greater than 100 and
therefore do not exceed HED’s level of concern.

D. Cumulative Effects

	Pyroxasulfone represents a new class of pyrazole herbicides.  No other
products are known to have the same mode of action as pyroxasulfone.
Therefore, a cumulative assessment is not appropriate at this time.

E. Safety Determination

	1. U.S. population. The toxicity database for pyroxasulfone is
complete. Based on the NOEL of 2 mg/kg/day from a 1-year toxicity study
in the dog, proposed uses represent 18.5% percent of the cRfD of 0.02
mg/kg/day for the total US population.  The aRfD used was 1 mg/kg/day as
referenced in EPA’s dietary assessment for amending the corn tolerance
dated 22 May 2014, DP Barcode D417422. The percent aRfD for the US
population was 2.03% for the 99th percentile. There is reasonable
certainty that no harm to the U.S. population will result from the
proposed uses of pyroxasulfone.

	2. Infants and children. The toxicity database for pyroxasulfone is
complete.  The database includes acute, subchronic, chronic,
mutagenicity, genotoxicity, developmental, reproduction, neurotoxicity
and immunotoxicity studies on pyroxasulfone and acute mutagenicity and
genotoxicity studies on several metabolites.  The weight of evidence
indicates that infants and children are not expected to be more
sensitive to pyroxasulfone than are adults.  Consequently, EPA reduced
the FQPA Safety Factor from 10x to 1x.

F. International Tolerances.

	Tolerances are approved on wheat, barley and triticale in Australia.
Tolerances are approved for corn and soybean in Canada and pending for
wheat.

 PAGE

 PAGE   2


[Federal Register Volume 85, Number 142 (Thursday, July 23, 2020)]
[Notices]
[Pages 44556-44559]
[FR Doc No: 2020-15911]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89339; File No. SR-NASDAQ-2020-042]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Order Granting Accelerated Approval of a Proposed
Rule Change To Add the Consolidated Audit Trail Industry Member
Compliance Rules to the List of Minor Rule Violations

July 17, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 14, 2020, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons and approving the proposal on an
accelerated basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to add the Consolidated Audit Trail (``CAT'')
industry member compliance rules to the list of minor rule violations
in IM-9216 and in Options 11, Section 1.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/nasdaq/rules, at
the principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to add Nasdaq's CAT industry member
compliance rules (the ``CAT Compliance Rules'') to the list of minor
rule violations in IM-9216 and in Options 11, Section 1. This proposal
is based upon the Financial Industry Regulatory Authority, Inc.
(``FINRA'') filing to amend FINRA Rule 9217 in order to add FINRA's
corresponding CAT Compliance Rules to FINRA's list of rules that are
eligible for minor rule violation plan treatment.\3\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 88870 (May 14,
2020), 85 FR 30768 (May 20, 2020) (SR-FINRA-2020-013); see also
Release No. 89123 (June 23, 2020), 85 FR 39016 (June 29, 2020) (SR-
NYSE-2020-51).
---------------------------------------------------------------------------

Proposed Rule Change
    The Exchange adopted the CAT Compliance Rules in General 7,
Sections 1 through 13 in order to implement the National Market System
Plan Governing the Consolidated Audit Trail (the ``CAT NMS Plan'' or
``Plan'').\4\ The CAT NMS Plan was filed by the Plan Participants

to comply with Rule 613 of Regulation NMS under the Exchange Act,\5\
and each Plan Participant accordingly has adopted the same compliance
rules as the Exchange's General 7 Sections. The common compliance rules
adopted by each Plan Participant are designed to require industry
members to comply with the provisions of the CAT NMS Plan, which
broadly calls for industry members to record and report timely and
accurately customer, order, and trade information relating to activity
in NMS Securities and OTC Equity Securities.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 80256 (March 15,
2017), 82 FR 14526 (March 21, 2017) (SR-NASDAQ-2017-008) (Order
Approving Proposed Rule Changes To Adopt Consolidated Audit Trail
Compliance Rules).
    \5\ 17 CFR 242.613.
---------------------------------------------------------------------------

    IM-9216 sets forth the list of rules under which a member or
associated person may be subject to a fine under Rule 9216(b). Exchange
Rule 9216 permits the Exchange to impose a fine (not to exceed $2,500)
and/or censure on any member or associated person with respect to any
rule listed under IM-9216. The Exchange proposes to amend IM-9216 to
add the CAT Compliance Rules in General 7 to the list of rules in IM-
9216 eligible for disposition pursuant to a minor fine under Rule
9216(b). In addition, Options 11, Section 1 sets forth the minor rule
violation plan for Options Participants on The Nasdaq Options Market
(``NOM''). Accordingly, the Exchange proposes to make conforming
changes in Options 11, Section 1 to add the CAT Compliance Rules to the
list of rules therein, and specify that for failures to comply with the
Consolidated Audit Trail Compliance Rule requirements under General 7,
the Exchange may impose a minor rule violation fine of up to $2,500.\6\
---------------------------------------------------------------------------

    \6\ FINRA's maximum fine for minor rule violations under FINRA
Rule 9216(b) is $2,500. The Exchange will apply an identical maximum
fine amount for eligible violations of the General 7 Sections to
achieve consistency with FINRA and also to amend its minor rule
violation plan (``MRVP'') to include such fines. Like FINRA, the
Exchange would be able to pursue a fine greater than $2,500 for
violations of the rules in General 7, Sections in a regular
disciplinary proceeding or an acceptance, waiver, and consent
(``AWC'') under the Rule 9000 Series as appropriate. Any fine
imposed in excess of $2,500 or not otherwise covered by Rule 19d-
1(c)(2) of the Act would be subject to prompt notice to the
Commission pursuant to Rule 19d-1 under the Act. As noted below, in
assessing the appropriateness of a minor rule fine with respect to
CAT Compliance Rules, the Exchange will be guided by the same
factors that FINRA utilizes. See text accompanying notes 8-9, infra.
---------------------------------------------------------------------------

    The Exchange is coordinating with FINRA and other Plan Participants
to promote harmonized and consistent enforcement of all the Plan
Participants' CAT Compliance Rules. The Commission recently approved a
Rule 17d-2 Plan under which the regulation of CAT Compliance Rules will
be allocated among Plan Participants to reduce regulatory duplication
for industry members that are members of more than one Participant
(``common members'').\7\ Under the Rule 17d-2 Plan, the regulation of
CAT Compliance Rules with respect to common members that are members of
FINRA is allocated to FINRA. Similarly, under the Rule 17d-2 Plan,
responsibility for common members of multiple other Plan Participants
and not a member of FINRA will be allocated among those other Plan
Participants, including to the Exchange. For those non-common members
who are allocated to Nasdaq pursuant to the Rule 17d-2 Plan, the
Exchange and FINRA entered into a Regulatory Services Agreement
(``RSA'') pursuant to which FINRA will conduct surveillance,
investigation, examination, and enforcement activity in connection with
the CAT Compliance Rules on the Exchange's behalf. We expect that the
other exchanges would be entering into a similar RSA.
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 88366 (March 12,
2020), 85 FR 15238 (March 17, 2020) (File No. 4-618).
---------------------------------------------------------------------------

    FINRA, in connection with its proposed amendment to FINRA Rule 9217
to make FINRA's CAT Compliance Rules MRVP eligible, has represented
that it will apply the minor fines for CAT Compliance Rules in the same
manner that FINRA has for its similar existing audit trail-related
rules.\8\ Accordingly, in order to promote regulatory consistency, the
Exchange plans to do the same. Specifically, application of a minor
rule fine with respect to CAT Compliance Rules will be guided by the
same factors that FINRA referenced in its filing. However, more formal
disciplinary proceedings may be warranted instead of minor rule
dispositions in certain circumstances such as where violations prevent
regulatory users of the CAT from performing their regulatory functions.
Where minor rule dispositions are appropriate, the following factors
help guide the determination of fine amounts:
---------------------------------------------------------------------------

    \8\ See SR-FINRA-2020-013; see also FINRA Notice to Members 04-
19 (March 2004) (providing specific factors used to inform
dispositions for violations of OATS reporting rules).
---------------------------------------------------------------------------

     Total number of reports that are not submitted or
submitted late;
     The timeframe over which the violations occur;
     Whether violations are batched;
     Whether the violations are the result of the actions of
one individual or the result of faulty systems or procedures;
     Whether the firm has taken remedial measures to correct
the violations;
     Prior minor rule violations within the past 24 months;
     Collateral effects that the failure has on customers; and
     Collateral effects that the failure has on the Exchange's
ability to perform its regulatory function.\9\
---------------------------------------------------------------------------

    \9\ See id.
---------------------------------------------------------------------------

    Upon effectiveness of this rule change, the Exchange will publish a
regulatory alert notifying its members, associated persons, or Options
Participants of the rule change and the specific factors that will be
considered in connection with assessing minor rule fines described
above.
    For the foregoing reasons, the Exchange believes that the proposed
rule change will result in a coordinated, harmonized approach to CAT
compliance rule enforcement across Plan Participants that will be
consistent with the approach FINRA has taken with the CAT rules.
    Additionally, the Exchange proposes to make a technical change to
remove a cross reference to General 5, Section 2 in Options 11.
Currently, Nasdaq Rule General 5 does not have a Section 2. Therefore,
the Exchange is deleting the erroneous cross reference to Section 2.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\10\ in general, and furthers the objectives of Section
6(b)(5),\11\ in particular, because it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, to
remove impediments to, and perfect the mechanism of, a free and open
market and a national market system and, in general, to protect
investors and the public interest.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Minor rule fines provide a meaningful sanction for minor or
technical violations of rules when the conduct at issue does not
warrant stronger, immediately reportable disciplinary sanctions. The
inclusion of a rule in the Exchange's MRVP does not minimize the
importance of compliance with the rule, nor does it preclude the
Exchange from choosing to pursue violations of eligible rules through
an AWC if the nature of the violations or prior disciplinary history
warrants more significant sanctions. Rather, the

Exchange believes that the proposed rule change will strengthen the
Exchange's ability to carry out its oversight and enforcement
responsibilities in cases where full disciplinary proceedings are
unwarranted in view of the minor nature of the particular violation.
Rather, the option to impose a minor rule sanction gives the Exchange
additional flexibility to administer its enforcement program in the
most effective and efficient manner while still fully meeting the
Exchange's remedial objectives in addressing violative conduct.
Specifically, the proposed rule change is designed to prevent
fraudulent and manipulative acts and practices because it will provide
the Exchange the ability to issue a minor rule fine for violations of
the CAT Compliance Rules in General 7 where a more formal disciplinary
action may not be warranted or appropriate consistent with the approach
of other Plan Participants for the same conduct.
    The Exchange further believes that the proposed amendments to IM-
9216 and Options 11, Section 1 are consistent with Section 6(b)(6) of
the Act,\12\ which provides that members, or associated persons, or
Options Participants shall be appropriately disciplined for violation
of the provisions of the rules of the exchange, by expulsion,
suspension, limitation of activities, functions, and operations, fine,
censure, being suspended or barred from being associated with a member,
or any other fitting sanction. As noted, the proposed rule change would
provide the Exchange ability to sanction minor or technical violations
of General 7 pursuant to the Exchange's rules.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b)(6).
---------------------------------------------------------------------------

    The Exchange also believes that the proposed changes are designed
to provide a fair procedure for the disciplining of a member, or
associated person, or Options Participant consistent with Sections
6(b)(7) and 6(d) of the Act.\13\ IM-9216 and Options 11, Section 1 do
not preclude a member, or associated person, or Options Participant
from contesting an alleged violation and receiving a hearing on the
matter with the same procedural rights through a litigated disciplinary
proceeding.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b)(7) and 78f(d).
---------------------------------------------------------------------------

    Finally, removing the erroneous cross reference in Options 11 is
reasonable as it would add clarity to the Exchange's rules.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
not intended to address competitive issues but rather is concerned
solely with making the CAT Compliance Rules in General 7 eligible for a
minor rule fine disposition, thereby strengthening the Exchange's
ability to carry out its oversight and enforcement functions and deter
potential violative conduct.
    Removing the erroneous cross reference to Section 2 in Options 11
is not designed to impact competition but instead should add clarity to
the Exchange's rules.

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

    No written comments were either solicited or received.

III. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2020-042 the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2020-042. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NASDAQ-2020-042 and should be submitted
on or before August 13, 2020.

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\14\ In
particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act,\15\ which requires that the
rules of an exchange be designed to promote just and equitable
principles of trade, to remove impediments and to perfect the mechanism
of a free and open market and a national market system, and, in
general, to protect investors and the public interest. The Commission
also believes that the proposal is consistent with Sections 6(b)(1) and
6(b)(6) of the Act \16\ which require that the rules of an exchange
enforce compliance with, and provide appropriate discipline for,
violations of Commission and Exchange rules. Finally, the Commission
finds that the proposal is consistent with the public interest, the
protection of investors, or otherwise in furtherance of the purposes of
the Act, as required by Rule 19d-1(c)(2) under the Act,\17\ which
governs minor rule violation plans.
---------------------------------------------------------------------------

    \14\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \15\ 15 U.S.C. 78f(b)(5).
    \16\ 15 U.S.C. 78f(b)(1) and 78f(b)(6).
    \17\ 17 CFR 240.19d-1(c)(2).
---------------------------------------------------------------------------

    As stated above, the Exchange proposes to add the CAT Compliance
Rules to the list of minor rule violations in IM-9216 and in Options
11, Section

1 to be consistent with the approach FINRA has taken for minor
violations of its corresponding CAT Compliance Rules.\18\ The
Commission has already approved FINRA's treatment of CAT Compliance
Rules violations when it approved the addition of CAT Compliance Rules
to FINRA's MRVP.\19\ As noted in that order, and similarly herein, the
Commission believes that Exchange's treatment of CAT Compliance Rules
violations as part of its MRVP provides a reasonable means of
addressing violations that do not rise to the level of requiring formal
disciplinary proceedings, while providing greater flexibility in
handling certain violations. However, the Commission expects that, as
with FINRA, the Exchange will continue to conduct surveillance with due
diligence and make determinations based on its findings, on a case-by-
case basis, regarding whether a sanction under the rule is appropriate,
or whether a violation requires formal disciplinary action.
Accordingly, the Commission believes the proposal raises no novel or
significant issues.
---------------------------------------------------------------------------

    \18\ As discussed above, the Exchange has entered into a Rule
17d-2 Plan and an RSA with FINRA with respect to the CAT Compliance
Rules. The Commission notes that, unless relieved by the Commission
of its responsibility, as may be the case under the Rule 17d-2 Plan,
the Exchange continues to bear the responsibility for self-
regulatory conduct and liability for self-regulatory failures, not
the self-regulatory organization retained to perform regulatory
functions on the Exchange's behalf pursuant to an RSA. See
Securities Exchange Release No. 61419 (January 26, 2010), 75 FR 5157
(February 1, 2010) (SR-BATS-2009-031), note 93 and accompanying
text.
    \19\ See SR-FINRA-2020-013.
---------------------------------------------------------------------------

    For the same reasons discussed above, the Commission finds good
cause, pursuant to Section 19(b)(2) of the Act,\20\ for approving the
proposed rule change prior to the thirtieth day after the date of
publication of the notice of the filing thereof in the Federal
Register. The proposal merely adds the CAT Compliance Rules to the
Exchange's MRVP and harmonizes its application with FINRA's application
of CAT Compliance Rules under its own MRVP. Accordingly, the Commission
believes that a full notice-and-comment period is not necessary before
approving the proposal.
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act
\21\ and Rule 19d-1(c)(2) thereunder,\22\ that the proposed rule change
(SR-NASDAQ-2020-042) be, and hereby is, approved on an accelerated
basis.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(2).
    \22\ 17 CFR 240.19d-1(c)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-15911 Filed 7-22-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 43 (Monday, March 8, 2021)]
[Proposed Rules]
[Pages 13264-13266]
[FR Doc No: 2021-04031]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2021-0136; FRL-10020-59-Region 7]

Air Plan Approval; Missouri; Control of Volatile Organic Compound
Emissions From Wood Furniture Manufacturing Operations

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Missouri State Implementation Plan (SIP)
received on February 15, 2019. The submission revises Missouri's
regulation that restricts the emissions of volatile organic compounds
from wood furniture manufacturing operations in St. Louis City and
Jefferson, St. Charles, Franklin, and St. Louis Counties. Specifically,
the revisions to the proposed rule specify that this proposed rule only
applies to sources that were existing at the time of the rule's
promulgation, remove the unnecessary use of restrictive words, update
references, and make minor clarifications and grammatical changes.
These revisions do not have an adverse effect on air quality. The EPA's
proposed approval of this proposed rule revision is being done in
accordance with the requirements of the Clean Air Act (CAA). Approval
of these revisions will ensure consistency between state and federally-
approved rules.

DATES: Comments must be received on or before April 7, 2021.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-R07-
OAR-2021-0136, to https://www.regulations.gov. Follow the online
instructions for submitting comments.
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received will be posted without
change to https://www.regulations.gov/, including any personal
information provided. For detailed instructions on sending comments and
additional information on the rulemaking process, see the ``Written
Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.

FOR FURTHER INFORMATION CONTACT: William Stone, Environmental
Protection Agency, Region 7 Office, Air Quality Planning Branch, 11201
Renner Boulevard, Lenexa, Kansas 66219; telephone number: (913) 551-
exception occurred on : 2021-04031.htm
exception occurred on : 2021-04031.htm
7714; email address: st[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to the EPA.

Table of Contents

I. Written Comments
II. What is being addressed in this document?
III. Background
IV. What is the EPA's analysis of Missouri's SIP revision request?
V. Have the requirements for approval of a SIP revision been met?
VI. What action is the EPA taking?
VII. Incorporation by Reference
VIII. Statutory and Executive Order Reviews

I. Written Comments

    Submit your comments, identified by Docket ID No. EPA-R07-OAR-2021-
0136, at https://www.regulations.gov. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e. on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

II. What is being addressed in this document?

    The EPA is proposing to approve revisions to the Missouri SIP
received on February 15, 2019. The revisions are to Title 10, Division
10 of the Code of State Regulations, 10 CSR 10-5.530 ``Control of
Volatile Organic Compound Emissions From Wood Furniture Manufacturing
Operations'', which restricts the emissions of volatile organic
compounds (VOC) from wood furniture manufacturing operations in St.
Louis City and Jefferson, St. Charles, Franklin, and St. Louis Counties
(hereinafter referred to in this document as the ``St. Louis Area'').
These revisions are described in detail in the technical support
document (TSD) included in the docket for this action.
    Missouri received six comments from the EPA during the comment
period. Missouri responded to all six comments, as noted in the State
submission included in the docket for this action.
    Missouri also provided supplemental information which is included
in the docket that addressed the comments. The EPA is proposing to
approve the revisions to this rulemaking because it will not have a
negative impact on air quality.

III. Background

    The EPA first approved 10 CSR 10-5.530 ``Control of Volatile
Organic Compound Emissions From Wood Furniture Manufacturing
Operations'', into the Missouri SIP as a reasonably available control
technology (RACT) rule on May 18, 2000 (65 FR 31489, May 18, 2000). At
the time the rule was approved into the SIP, 10 CSR 10-5.530 applied to
all wood furniture manufacturing installations throughout the St. Louis
Area that had the potential to emit equal to or greater than twenty-
five (25) tons per year of VOC.
    By letter dated February 15, 2019, Missouri requested that the EPA
approve revisions to 10 CSR 10-5.530 into the SIP. Section 110(l) of
the CAA prohibits the EPA from approving a SIP revision that interferes
with any applicable requirement concerning attainment and reasonable
further progress (RFP), or any other applicable requirement of the CAA.
The State supplemented its SIP revision with a August 1, 2019 letter in
order to address the requirements of section 110(l) of the CAA.

IV. What is the EPA's analysis of Missouri's SIP revision request?

    In its August 1, 2019 letter, Missouri states that it intended its
RACT rules, such as 10 CSR 10 5.530, to solely apply to existing
sources in accordance with section 172(c)(1) of the CAA.\1\ Missouri
states that although the applicability section of 10 CSR 10 5.530
specifies that the rule applies to all installations located throughout
the St. Louis Area, the only facilities that met the applicability
criteria of the rule were (1) K & R Wood Products Inc in St. Charles
County, (2) Integram--St. Louis Seating in Franklin County, and (3)
Lozier (Formerly Spartan) in Franklin County.
---------------------------------------------------------------------------

    \1\ The EPA agrees with Missouri's interpretation of CAA section
172(c)(1) in regard to whether RACT is required for existing
sources, but also notes that the State regulation establishing RACT
may apply to new sources as well, dependent upon the State
regulation's language.
---------------------------------------------------------------------------

    Missouri, in its August 1, 2019 letter, indicated K & R Wood
Products Inc in St. Charles County, Integram--St. Louis Seating in
Franklin County and Lozier (Formerly Spartan) in Franklin County all
went ``out of business'' in 2009, 2010

and 2017, respectively. The EPA confirmed all three facilities are no
longer in operation \2\ and are therefore no longer subject to 10 CSR
10-5.530.
---------------------------------------------------------------------------

    \2\ The EPA reviewed MoDNR's website that lists active, issued
permits to facilities in Missouri and did not observe a permit for
these facilties. Further, the EPA reviewed EPA's ICIS-Air database
which indicated that two of the facilties are ``permanently
closed.'' The website for the third facility, Lozier, indicated no
operations in the St. Louis Area.
---------------------------------------------------------------------------

    A fourth business, Artistic Wood of St. Louis Cuunty, was
referenced in the St. Louis Ozone Nonattainment Area Rate Of Progress
Plan which is included in the docket for this action. Missouri
Department of Natural Resources (MoDNR) determined that Artistic Wood
was never subject to the rule, because its potential to emit (PTE) was
below the applicability threshold of 25 tons per year (tpy). This
source went out of business in 2006.
    A fifth business, Lami Wood Products of St. Charles County, is
still in operation, but is not subject to the rule because the source
has taken a federally enforceable voluntary permit limit. The
intermediate operating permit, number OP2017-070, including this limit,
was issued September 8, 2017 and is included in the docket for this
action.
    As stated above, Missouri contends that the applicability section
of 10 CSR 10-5.530 may be revised to apply only to existing sources
because section 172(c)(1) of the CAA requires RACT for existing
sources. Because 10 CSR 10-5.530 was applicable only to sources that
are out of business or have taken limits and are no longer subject to
the rule, the rule no longer reduces VOC emissions. Because these
facilities are no longer subject to the rule, the EPA believes the rule
no longer provides an emission reduction benefit to the St. Louis Area
and therefore approving the revisions to applicability portion of this
rule will not have a negative impact on air quality.
    Missouri's August 1, 2019 letter states that any new sources or
major modifications of existing sources are subject to new source
review (NSR) permitting. Under NSR, a new major source or major
modification of an existing source with a PTE of 250 tpy \3\ or more of
any national ambient air quality standards (NAAQS) pollutant is
required to obtain a Prevention of Significant Deterioration (PSD)
permit when the source is in an area designated as attainment or
unclassifiable, which requires an analysis of Best Available Control
Technology (BACT) in addition to an air quality analysis and an
additional impacts analysis. Sources with a PTE greater than 100 tpy,
but less than 250 tpy \4\, are required to obtain a minor permit in
accordance with Missouri's NSR permitting program, which is approved
into the SIP.\5\ Further, a new major source or major modification of
an existing source with a PTE of 100 tpy or more of any NAAQS pollutant
is required to obtain a nonattainment (NA) NSR permit when the area is
in nonattainment, which requires an analysis of Lowest Achievable
Emission Rate (LAER) in addition to an air quality analysis, an
additional impacts analysis and emission offsets. The EPA agrees with
this analysis.
---------------------------------------------------------------------------

    \3\ The PSD major source threshold for certain sources is 100
tpy rather than 250 tpy (see 40 CFR 52.21(b)(1)(i)(a) and 10 C.S.R.
10-6.060(8)(A)).
    \4\ Except for those sources with a PSD major source threshold
of 100 tpy.
    \5\ The EPA's latest approval of Missouri's NSR permitting
program rule was published in the Federal Register on October 11,
2016 (81 FR 70025).
---------------------------------------------------------------------------

V. Have the requirements for approval of a SIP revision been met?

    The state submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
state provided public notice on this SIP revision from June 15, 2018,
to September 6, 2018, and held a public hearing on August 30, 2018. The
state received and addressed six comments from the EPA. As explained in
more detail in the TSD which is included in the docket for this action,
the SIP revision submission meets the substantive requirements of the
CAA, including section 110 and implementing regulations.

VI. What action is the EPA taking?

    The EPA is proposing to amend the Missouri SIP by approving the
State's request to revise 10 CSR 10-5.530 ``Control of Volatile Organic
Compound Emissions From Wood Furniture Manufacturing Operations.''
Approval of these revisions will ensure consistency between state and
federally-approved rules. Based on analysis in the TSD included in the
docket for this action, the EPA has determined that these changes will
not adversely impact air quality.
    The EPA is processing this as a proposed action because we are
soliciting comments on the action. Final rulemaking will occur after
consideration of any comments.

VII. Incorporation by Reference

    In this document, the EPA is proposing to include regulatory text
in a final rule that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the Missouri Regulations described in the proposed amendments
to 40 CFR part 52 set forth below. The EPA has made, and will continue
to make, these materials generally available through
www.regulations.gov and at the EPA Region 7 Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).

VIII. Statutory and Executive Order Reviews

    Under the Clean Air Act (CAA), the Administrator is required to
approve a SIP submission that complies with the provisions of the Act
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of the National Technology
Transfer and Advancement Act (NTTA) because this

rulemaking does not involve technical standards; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where the EPA or an Indian tribe has demonstrated
that a tribe has jurisdiction. In those areas of Indian country, the
proposed rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Volatile organic compounds.

    Dated: February 22, 2021.
Edward H. Chu,
Acting Regional Administrator, Region 7.

    For the reasons stated in the preamble, the EPA proposes to amend
40 CFR part 52 as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart AA--Missouri

0
2. In Sec.  52.1320, the table in paragraph (c) is amended by revising
the entry ``10-5.530'' to read as follows:

Sec.  52.1320   Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Missouri Regulations
----------------------------------------------------------------------------------------------------------------
                                                       State
   Missouri citation              Title           effective date     EPA approval date          Explanation
----------------------------------------------------------------------------------------------------------------
                                    Missouri Department of Natural Resources
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
   Chapter 5--Air Quality Standards and Air Pollution Control Regulations for the St. Louis Metropolitan Area
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
10-5.530...............  Control of Volatile           2/28/2019  [Date of publication
                          Organic Compound                         of the final rule in
                          Emissions From Wood                      the Federal
                          Furniture                                Register], [Federal
                          Manufacturing                            Register citation of
                          Operations.                              the final rule].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2021-04031 Filed 3-5-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 98 (Wednesday, May 21, 2014)]
[Notices]
[Pages 29177-29178]
[FR Doc No: 2014-11721]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER14-225-002.
    Applicants: New Brunswick Energy Marketing Corporation.
    Description: Second Supplement to February 14, 2014 Triennial
Review Compliance Filing of New Brunswick Energy Marketing Corporation.
    Filed Date: 5/9/14.
    Accession Number: 20140509-5045.
    Comments Due: 5 p.m. ET 5/30/14.

    Docket Numbers: ER14-972-002.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance Filing per 4/9/2014 Order in Docket No.
ER14-972-000 to be effective N/A.
    Filed Date: 5/9/14.
    Accession Number: 20140509-5193.
    Comments Due: 5 p.m. ET 5/30/14.

    Docket Numbers: ER14-1939-000.
    Applicants: ISO New England Inc.
    Description: Identification of Potential New Capacity Zone Boundary
and Request for Waiver of ISO New England Inc.
    Filed Date: 5/9/14.
    Accession Number: 20140509-5214.
    Comments Due: 5 p.m. ET 5/19/14.

    Docket Numbers: ER14-1940-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: 2014-05-08 Docket No. ER14--------000 Schedule 29
Filing to be effective 6/30/2013.
    Filed Date: 5/12/14.
    Accession Number: 20140512-5053.
    Comments Due: 5 p.m. ET 6/2/14.

    Docket Numbers: ER14-1940-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: 2014-05-08 Docket No. ER14--------000 Schedule 29
Reconciliation Filing to be effective 4/12/2014.
    Filed Date: 5/12/14.
    Accession Number: 20140512-5059.
    Comments Due: 5 p.m. ET 6/2/14.

    The filings are accessible in the Commission's eLibrary system by

clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 12, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-11721 Filed 5-20-14; 8:45 am]
BILLING CODE 6717-01-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

			OFFICE OF THE SECRETARY

		WASHINGTON, D.C.

		Issued by the Department of Transportation on January 31, 2006

NOTICE OF ACTION TAKEN -- DOCKET OST-2006-23731

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  VOLGA-DNEPR J.S. CARGO AIRLINE (“Volga-Dnepr”)
  Date Filed:  January 25, 2006

Relief requested:  Exemption from 49 USC § 40109(g) to permit the
applicant to operate one, one-way, all-cargo charter flight, using its
AN-124-100 aircraft, carrying outsized cargo on behalf of Lockheed
Martin Space Systems (LMSS), from North Island NAS, California, to
Denver, Colorado, during the period February 1 through February 3, 2006.
 The applicant states that the flight would carry a LMSS Centaur III
Launch Vehicle Upper Stage and associated equipment.  The applicant
asserts that LMSS needs the subject lift to complete an aggressive final
assembly and fabrication schedule in order to maintain launch
integration activities; that the cargo is too large for transportation
on U.S.-carrier aircraft; and that surface transportation is not
feasible because of the delicate nature and extremely high value of the
cargo.

Applicant representative:  Glenn P. Wicks,<PHONE_NUMBER>      		   DOT
analyst:  Robert J. Finamore,<PHONE_NUMBER>

Responsive pleadings:  Volga-Dnepr served its application on those U.S.
carriers operating large all-cargo aircraft.  Each carrier indicated
that it did not have aircraft available to conduct the proposed
operations and that it had no comment or did not oppose grant of the
requested authority.

Statutory Standards:  Under 49 USC § 40109(g), we may authorize a
foreign air carrier to carry commercial traffic between U.S. points
(i.e., cabotage traffic) under limited circumstances.  Specifically, we
must find that the authority is required in the public interest; that
because of an emergency created by unusual circumstances not arising in
the normal course of business the traffic cannot be accommodated by U.S.
carriers holding certificates under 49 USC § 41102; that all possible
efforts have been made to place the traffic on U.S. carriers; and that
the transportation is necessary to avoid unreasonable hardship to the
traffic involved (an additional required finding, concerning emergency
transportation during labor disputes, was not relevant here).

DISPOSITION

Action: Approved
                                                          Action date:
January 31, 2006

Effective dates of authority granted: February 1, 2006, through February
3, 2006.

Basis for approval:  We are granting Volga-Dnepr’s request to operate
the proposed one-way flight (described above), on behalf of LMSS.  We
found that its request met all the relevant criteria of 49 USC §
40109(g) for the grant of an exemption of this type, and that the grant
was required in the public interest.  Specifically, we were persuaded
that the need to move the cargo to complete an aggressive final assembly
and fabrication schedule in order to maintain launch integration
activities; the fact that the cargo could not be transported by surface
because of its delicate nature and extremely high value; and the unique,
outsized nature of the cargo, constituted an emergency not arising in
the normal course of business.  Moreover, based on the representations
of the U.S. carriers, we concluded that no U.S. carrier had aircraft
available that could be used to conduct the operation at issue here.  We
also found that grant of this authority would prevent unreasonable
hardship to LMSS.  Finally, we found that the applicant was qualified to
perform its proposed operation.

Except to the extent exempted/waived, this authority is subject to our
standard exemption conditions (attached) and to the condition that the
applicant must comply with an FAA-approved flight routing for the
authorized operation.

Action taken by:        				Michael W. Reynolds

Acting Assistant Secretary for Aviation

and International Affairs

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

FOREIGN CARRIER EXEMPTION CONDITIONS
                       		       ATTACHMENT

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

1) Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

2) Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

3) Comply with the requirements for minimum insurance coverage contained
in 14 CFR Part 205, and, prior to the commencement of any operations
under this authority, file evidence of such coverage, in the form of a
completed OST Form 6411, with the Federal Aviation Administration’s
Program Management Branch (AFS-260), Flight Standards Service (any
changes to, or termination of, insurance also shall be filed with that
office);

4) Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

5) Conform to the airworthiness and airman competency requirements of
its Government for international air services;

6) Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

7) Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: a) based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or b) based on
a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term “international air transportation” means “international
transportation” as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

8) Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

9) Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department’s
rules governing charters (including 14 CFR Parts 212 and 380); and

11) Comply with such other reasonable terms, conditions, and limitations
required by the public interest as may be prescribed by the Department,
with all applicable orders or regulations of other U.S. agencies and
courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

05/2004


[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Notices]
[Pages 14221-14223]
[FR Doc No: 2017-05293]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0536]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Pharmacogenomic Data
Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (the PRA), Federal Agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension of an existing
collection of information, and to allow 60 days for public comment in
response to the notice. This notice solicits comments on the
information collection resulting from the submission to the Agency of
pharmacogenomic data during the drug development process.

DATES: Submit either electronic or written comments on the collection
of information by May 16, 2017.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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 No.
FDA-2010-N-0536 for ``Guidance for Industry on Pharmacogenomic Data
Submissions.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the

Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     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 Division of Dockets Management. 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 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry on Pharmacogenomic Data Submissions

OMB Control Number 0910-0557--Extension

    The guidance provides recommendations to sponsors submitting or
holding investigational new drug applications (INDs), new drug
applications (NDAs), or biologics license applications (BLAs) on what
pharmacogenomic data should be submitted to the Agency during the drug
development process. Sponsors holding, and applicants submitting, INDs,
NDAs, or BLAs are subject to FDA requirements for submitting to the
Agency data relevant to drug safety and efficacy (21 CFR 312.22,
312.23, 312.31, 312.33, 314.50, 314.81, 601.2, and 601.12).
    The guidance interprets FDA regulations for IND, NDA, or BLA
submissions, clarifying when the regulations require pharmacogenomics
data to be submitted and when the submission of such data is voluntary.
The pharmacogenomic data submissions described in the guidance that are
required to be submitted to an IND, NDA, BLA, or annual report are
covered by the information collection requirements under parts 312,
314, and 601 (approved under OMB control numbers 0910-0014 (part 312,
INDs); 0910-0001 (part 314, NDAs and annual reports); and 0910-0338
(part 601, BLAs)).
    The guidance distinguishes between pharmacogenomic tests that may
be considered valid biomarkers appropriate for regulatory decision-
making, and other, less well-developed exploratory tests. The
submission of exploratory pharmacogenomic data is not required under
the regulations, although the Agency encourages the voluntary
submission of such data.
    The guidance describes the voluntary genomic data submission (VGDS)
that can be used for such a voluntary submission. The guidance does not
recommend a specific format for the VGDS, except that such a voluntary
submission be designated as a VGDS. The data submitted in a VGDS and
the level of detail should be sufficient for FDA to be able to
interpret the information and independently analyze the data, verify
results, and explore possible genotype-phenotype correlations across
studies. FDA does not want the VGDS to be overly burdensome and time
consuming for the sponsor.
    FDA has estimated the burden of preparing a voluntary submission
described in the guidance that should be designated as a VGDS, based on
our experience with these submissions over the past few years, and on
our familiarity with sponsors' interest in submitting pharmacogenomic
data during the drug development process. In 2013, we received three
VGDS. Since 2013, there have been no submission of VGDS, however, for
purposes of this information collection approval, we are estimating
that we may receive one submission annually. We estimate each
submission requires approximately 50 hours to prepare and submit to
FDA.
    We therefore estimate the burden of this collection of information
as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                  Information collection activity                       Number of      responses per     Total annual      Hours per       Total hours
                                                                       respondents       respondent       responses         response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary Genomic Data Submissions.................................               1                1                1               50               50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.

    Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05293 Filed 3-16-17; 8:45 am]
 BILLING CODE 4164-01-P