intervals.  The modeled scenario reflects a region with high rainfall
and high vulnerability to runoff.  A default PCA factor of 0.87 was
used.  The Tier II modeling predicts that the concentrations of
pyraclostrobin in surface water are not likely to exceed 10.2 µg/L for
the peak concentration, 0.8 µg/L for the annual average concentration,
and 0.5 µg/L for the 30 year average concentrations.

The ground water concentrations were estimated using a Tier I SCI-GROW
model (version 2.2, Nov. 1, 2001).  The assessment was based on the
highest registered use rate of pyraclostrobin on turf.  The SCI-GROW
model predicts the acute and chronic concentrations of pyraclostrobin in
shallow ground water to be 0.02 ppb.  Ground water sources were not
included in the dietary assessment, as the EDWCs for this water source
are minimal in comparison to surface water.

4.1.10	Proposed Tolerances TC \l3 "4.1.10	Proposed Tolerances

For purposes of both the tolerance expression and dietary risk
assessment, HED has concluded that the residues of concern in plant
commodities include pyraclostrobin and its desmethoxy metabolite, BF
500-3 (D278044, L. Cheng, 10/9/01), and the residues of concern in
livestock commodities include pyraclostrobin and its metabolites
convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol (BF 500-5) and
1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol (BF 500-8).

Tolerances for plant commodities are currently established for the
combined residues of pyraclostrobin and BF 500-3, expressed as parent,
in plant commodities at levels ranging from 0.02 ppm in/on wheat grain
to 29 ppm in/on leafy vegetables, except Brassica [40 CFR
§180.582(a)(1)].  Tolerances for livestock commodities are established
for the combined residues of pyraclostrobin and its metabolites
convertible to BF 500-5 or BF 500-8, each expressed as parent, at levels
ranging from 0.1 ppm in milk, meat, and fat to 1.5 ppm in liver of
cattle, goats, hogs, horses, and sheep [40 CFR §180.582(a)(2)].  No
tolerances are established for poultry commodities.

The tolerances proposed by BASF and IR-4 for the current petitions are
listed in Table 8, along with the Agency’s recommended tolerance
levels.

The tolerance proposed for Belgian endive is denied, because the
application method used in the field residue trials does not agree with
the proposed use pattern, and the residue data generated from these
trials therefore do not support the proposed tolerance.  This deficiency
precludes the establishment of a permanent tolerance for pyraclostrobin
on the proposed commodity Belgian endive at this time.

As the majority of cottonseed samples from the cotton field trials had
residues below the combined LOQ (0.04 ppm), the recommended tolerance
level for undelinted seeds were not determined using the Tolerance/MRL
Harmonization Spreadsheet.  Rather, the recommended tolerance of 0.3 ppm
is based on the maximum combined residues observed in seeds (0.17 ppm).
Tolerances for cotton gin byproducts and the berries crop group were
both determined using the Tolerance/MRL Harmonization Spreadsheet as
combined residues were readily quantifiable in these commodities.  For
the berries crop group, residue values from both the earlier and new
berry field trials were used to calculate the appropriate tolerance, and
the data from raspberries and blueberries were pooled as residue levels
were similar on both types of berries.  The calculated tolerances were
30 ppm for cotton gin byproducts and 4.0 ppm for the berries crop group.

Results from the requested mustard greens field trials and the
supplemental field trials on cucurbit vegetables, fruiting vegetables,
grape, sunflower, and mint indicate that no changes are necessary in the
existing tolerances for these crops.  For each crop, the combined
residues in the new field trials were below the established tolerances.

With regards to the current tolerances for livestock commodities, the
existing tolerances are adequate for milk, meat, fat, meat byproducts
(except liver), and liver of cattle, goats, horses, and sheep, and the
current tolerances for liver could be lowered to 1.0 ppm.  Also, the
existing tolerances for hog commodities can be deleted as quantifiable
residues are unlikely to occur in hogs [40 CFR §180.6(a)(2)] based on
the dietary burden proposed in Table 6.  As stated previously,
tolerances are still not required for poultry commodities.

The Codex Alimentarius Commission, Mexico and Canada have not
established any maximum residue limits (MRLs) for residues of
pyraclostrobin in or on raw agricultural commodities, although a variety
of MRLs are pending in Canada (Appendix I).  Therefore, there are no
questions of compatibility of U.S. tolerances with International MRLs at
the present time.

Table 7. 	Tolerance Summary for Pyraclostrobin.

Commodity	Established/Proposed Tolerance (ppm)	Recommended Tolerance
(ppm)	Comments; Correct Commodity Definition

Belgian endive

	6	Denied	Denied, since field trial data does not support the proposed
tolerance.

Berry, group 13	1.3	4.0	Tolerance calculated using available residue
data and Tolerance/MRL Harmonization Spreadsheet.

Cotton, undelinted seed	0.4	0.3	Tolerance should be set at 0.3 ppm based
on maximum combined residues of 0.17 ppm.

Cotton, gin byproducts	30	30	Tolerance calculated using available
residue data and Tolerance/MRL Harmonization Spreadsheet.

4.2	Dietary Exposure and Risk TC \l2 "4.2  Dietary Exposure and Risk

References:  Pyraclostrobin. Acute and Chronic Aggregate Dietary and
Drinking Water Exposure and Risk Assessments to Support New Use on
Cotton, Belgian Endive, and Increased Tolerance on the Berries Crop
Group. PC Code: 099100; Decision Number: 363131; DP Number: 337818; L.
Cheng; 04/09/07.

Pyraclostrobin. Amended Acute and Chronic Aggregate Dietary and Drinking
Water Exposure and Risk Assessments to Support New Use on Cotton,
Belgian Endive, and Increased Tolerance on the Berries Crop Group. PC
Code: 099100; Decision Number: 363131; DP Number: 340582; L. Cheng;
06/13/07.

Dietary risk assessment incorporates both exposure and toxicity of a
given pesticide.  The risk is expressed as a percentage of a maximum
acceptable dose (i.e., the dose which HED has concluded will result in
no unreasonable adverse health effects).  This dose is referred to as
the population adjusted dose (PAD).  HED is concerned when estimated
dietary risk exceeds 100% of the PAD.

DEEM-FCID™ Program and Consumption Information

Pyraclostrobin acute and chronic dietary exposure assessments were
conducted using the Dietary Exposure Evaluation Model software with the
Food Commodity Intake Database (DEEM-FCID™, Version 2.03), which
incorporates consumption data from USDA’s Continuing Surveys of Food
Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98
data are based on the reported consumption of more than 20,000
individuals over two non-consecutive survey days.  Foods “as
consumed” (e.g., apple pie) are linked to EPA-defined food commodities
(e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour
- cooked; fresh or N/S, baked) using publicly available recipe
translation files developed jointly by USDA/ARS and EPA.  For chronic
exposure assessment, consumption data are averaged for the entire U.S.
population and within population subgroups, but for acute exposure
assessment are retained as individual consumption events.  Based on
analysis of the 1994-96, 98 CSFII consumption data, which took into
account dietary patterns and survey respondents, HED concluded that it
is most appropriate to report risk for the following population
subgroups: the general U.S. population, all infants (<1 year old),
children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49,
females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue
level in each food or food-form (e.g., orange or orange juice) on the
food commodity residue list is multiplied by the average daily
consumption estimate for that food/food form to produce a residue intake
estimate.  The resulting residue intake estimate for each food/food form
is summed with the residue intake estimates for all other food/food
forms on the commodity residue list to arrive at the total average
estimated exposure.  Exposure is expressed in mg/kg body weight/day and
as a percent of the cPAD.  This procedure is performed for each
population subgroup.

For acute exposure assessments, individual one-day food consumption data
are used on an individual-by-individual basis.  The reported consumption
amounts of each food item can be multiplied by a residue point estimate
and summed to obtain a total daily pesticide exposure for a
deterministic exposure assessment, or “matched” in multiple random
pairings with residue values and then summed in a probabilistic
assessment.  The resulting distribution of exposures is expressed as a
percentage of the aPAD on both a user (i.e., only those who reported
eating relevant commodities/food forms) and a per-capita (i.e., those
who reported eating the relevant commodities as well as those who did
not) basis.  In accordance with HED policy, per capita exposure and risk
are reported for all tiers of analysis.  However, for tiers 1 and 2, any
significant differences in user vs. per capita exposure and risk are
specifically identified and noted in the risk assessment.

Drinking Water Inputs

The drinking water residues used in the dietary risk assessment were
provided by the Environmental Fate and Effects Division (EFED) in the
following memorandum: “Drinking Water Assessment for the Use of
Pyraclostrobin (PC Code: 099100) on Undelinted Cotton Seed, Cotton Gin
By-Products, and Berries Group 13” (A. Al-Mudallal, D326246,
2/21/2007) and incorporated directly into this dietary assessment.  EFED
concluded that the proposed use rates are much lower than the use rate
on turf, the site that was selected for the drinking water assessment.
Therefore, the estimated concentrations in drinking water associated
with the turf use assessed in the previous Section 3 request for the use
of pyraclostrobin in-furrow on potatoes remain valid (D303496,
10/6/2004).  The drinking water assessment provides Tier II (PRZM
3.12/EXAMS 2.7.97) surface water modeling and Tier I (SCI-GROW)
groundwater modeling.  The modeling was conducted for the parent
compound only.  The residue concentrations from Tier II surface water
modeling are not expected to exceed 10.2 µg/L for the peak
concentration, 0.8 µg/L for the annual average concentration, and 0.5
µg/L for the 30 year average concentration. Residue concentration from
Tier I groundwater modeling is not expected to exceed 0.02 µg/L.  For
acute exposures the 10.2 µg/L peak concentration was used.  For chronic
exposures the 0.8 µg/L annual average concentration was used.  These
drinking water residues were incorporated in the DEEM-FCID into the food
categories “water, direct, all sources” and “water, indirect, all
sources.”

Residue Data used for Acute and Chronic Assessments

For the acute dietary analysis, tolerance level or highest field trial
residues were used for all crops.  One hundred percent crop treated was
assumed for all commodities in the assessment.  Default processing
factors were applied to all commodities except for apple juice, grape
juice, citrus juices, cottonseed oil, tomato paste, tomato puree, wheat
flour, and wheat germ where experimental factors were used.

For the chronic dietary analysis, average field trial residue values
were used for certain crops (grape, celery, spinach, tomato, pepper,
citrus, apple, leaf lettuce, head lettuce), which are the major dietary
contributors based on preliminary runs.  One hundred percent crop
treated was assumed for all commodities in the assessment.
Experimentally derived processing factors for apple juice, grape juice,
citrus juices, cottonseed oil, tomato paste, tomato puree, wheat flour,
and wheat germ were applied.  Note: Compared to the previous analysis,
dated 11/30/05, the following changes occurred: 1) Percent crop treated
information is no longer applied in the current chronic assessment; 2)
Anticipated residues were derived for the following crops in the chronic
assessment: apple, grape, head lettuce, leaf lettuce, orange, pepper,
and tomato; and 3) A cancer risk assessment has not been conducted since
cancer is no longer a concern for this chemical.

For risk assessment purposes only, i.e., to help set an upper bound risk
level, the available residue data for Belgian endive resulting from the
back pack sprayer method were used in the dietary assessment.

Results of Acute Dietary Exposure Analysis

The results of the acute dietary analysis for food only indicate that
acute dietary risks (food only) do not exceed HED’s level of concern
(less than 100% of the acute population adjusted dose (aPAD)) for the
U.S. population and all subgroups.  At the 95th percentile, the U.S.
population has an exposure from food only that results in a risk
estimated at < 2% of the aPAD.  The most highly exposed subpopulation is
“females 13-49 years” due to a substantially more sensitive
endpoint.  At the 95th percentile, this population subgroup has an
exposure from food only that results in a risk estimated at 78% of the
aPAD.

The results of the aggregate acute dietary analysis for food and water
indicate that acute dietary risks (food and water) do not exceed HED’s
level of concern (less than 100% of the acute population adjusted dose
(aPAD)) for the U.S. population and all subgroups. At the 95th
percentile, the U.S. population has an exposure from food and water that
results in a risk that is practically unchanged at <2% of the aPAD.  The
most highly exposed subpopulation is “females 13-49 years”.  At the
95th percentile, this population subgroup has an exposure from food and
water that is without change at 78% of the aPAD.

Results of Chronic Dietary Exposure Analysis

The results of the chronic dietary analysis for food only indicate that
chronic dietary risks (food only) do not exceed HED’s level of concern
(less than 100% of the chronic population adjusted dose (cPAD)) for the
U.S. population and all subgroups.  The U.S. population exposure from
food only results in a risk estimated at 19% of the cPAD.  The most
highly exposed is “children 1-2 years of age” with an exposure
estimated at 47% of the cPAD.

The results of the aggregate chronic dietary analysis for food and water
indicate that chronic dietary risks (food and water) do not exceed
HED’s level of concern for the U.S. population and all subgroups.  The
U.S. population exposure from food and water results in a risk estimated
at 19% of the cPAD.  The most highly exposed population subgroup is
“children 1 -2” with an exposure estimated at 48% of the cPAD.

The results of the chronic dietary exposure analysis (with and without
water) are reported in Tables 8 and 9, below.

Cancer Dietary Exposure Results and Characterization

The HED CARC has recently revisited the cancer classification for
pyraclostrobin, and reclassified pyraclostrobin as “not likely to be
carcinogenic to humans" and determined that regulation of cancer risk
using an MOE approach is no longer appropriate.

Table 8.  Summary of Dietary Exposure and Risk for Pyraclostrobin –
Food Only

Population Subgroup	Acute Dietary

(95th Percentile)	Chronic Dietary	Cancer

	Dietary Exposure (mg/kg/day)	% aPAD	Dietary Exposure

(mg/kg/day)	% cPAD	Dietary Exposure

(mg/kg/day)	Risk

General U.S. Population	0.041	1.4	0.0064	19	A separate quantitative
cancer risk assessment is not required.

All Infants (< 1 year old)	0.051	1.7	0.0099	29

	Children 1-2 years old	0.069	2.3	0.016	47

	Children 3-5 years old	0.061	2.0	0.012	36

	Children 6-12 years old	0.045	1.5	0.0074	22

	Youth 13-19 years old	0.034	1.1	0.0045	13

	Adults 20-49 years old	0.037	1.2	0.0053	16

	Adults 50+ years old	0.039	1.3	0.0065	19

	Females 13-49 years old	0.039	78	0.0051	15

Table 9.  Summary of Dietary Exposure and Risk for Pyraclostrobin –
Food & Water

Population Subgroup	Acute Dietary

(95th Percentile)	Chronic Dietary	Cancer

	Dietary Exposure (mg/kg/day)	% aPAD	Dietary Exposure

(mg/kg/day)	% cPAD	Dietary Exposure

(mg/kg/day)	Risk

General U.S. Population	0.041	1.4	0.0066	19	A separate quantitative
cancer risk assessment is not required.

All Infants (< 1 year old)	0.052	1.7	0.010	31

	Children 1-2 years old	0.070	2.3	0.016	48

	Children 3-5 years old	0.061	2.0	0.012	36

	Children 6-12 years old	0.045	1.5	0.0075	22

	Youth 13-19 years old	0.034	1.1	0.0046	14

	Adults 20-49 years old	0.037	1.2	0.0054	16

	Adults 50+ years old	0.040	1.3	0.0066	20

	Females 13-49 years old	0.039	78	0.0053	16

Conclusions

Acute and chronic exposures and risks do not exceed HED’s level of
concern for the U.S. population and for all relevant population
subgroups.  Since risk estimates are below HED’s level of concern, a
more highly refined analysis is not needed at this time.  Of note is
that contribution from drinking water is minimal.  HED concludes that
the acute and chronic exposure estimates are unlikely to underestimate
actual acute or chronic exposure.

4.3	Anticipated Residue and Percent Crop Treated (%CT) Information TC
\l2 "4.3 Anticipated Residue and Percent Crop Treated (%CT) Information

The acute and chronic dietary risk assessments are considered only
minimally refined.

The acute analysis was conducted using tolerance level residues or the
highest residues for all commodities.  These tolerance level or highest
residues were derived from field trial data conducted at the maximum
application rate and minimum PHI permitted on the proposed or existing
labels.  For all commodities 100% crop treated was assumed.  A limited
number of experimentally derived processing factors were used to refine
the acute analysis.

The chronic dietary assessment was conducted using tolerance level
residues for all crops except for apple, grape, head lettuce, leaf
lettuce, celery, spinach, orange, pepper and tomato where anticipated
average residue values were derived from crop field trials.  These field
trials represent maximum application rates and minimum PHIs.  For all
commodities 100% crop treated was assumed.  A limited number of
experimentally derived processing factors were used to refine the
analysis.

5.0	Residential (Non-Occupational) Exposure/Risk Characterization  TC
\l1 "5.0	Residential (Non-Occupational) Exposure/Risk Characterization

A product containing pyraclostrobin (i.e., Insignia®) is registered for
application to residential turf grass and recreational sites.  It may be
applied to turf at rates ranging from 0.28 to 0.5 lb ai/A, at intervals
of 14 to 28 days; and the maximum seasonal application rate is 3 lb
ai/A.  The residential exposure assessment was prepared in an HED
memorandum dated 8/19/04 (D298017, K. O’Rourke).  Residential and
recreational turf applications are applied by professional pest control
operators (PCOs) only, and therefore, residential handler exposures do
not occur.  There is, however, a potential for exposure to homeowners in
residential settings from entering previously treated lawns where
children might play and adults might work or play.  As a result, risk
assessments have been completed for postapplication scenarios.  The
short-term MOEs for each postapplication scenario resulted in MOEs above
100, and therefore are not of concern.  Specifically, for toddlers, the
short-term dermal MOE is 180 (0.027 mg/kg/day) and the combined
incidental oral MOE is 620 (0.009425 mg/kg/day; hand-to-mouth
activities), and combined dermal and oral exposures result in and MOE of
140, and therefore are not of concern.  These exposures are combined,
because they share common toxic effects; i.e., decreased body weight
gain and decreased food intake/efficiency.

Recreational exposures to turf are expected to be similar to, or in many
cases less than, those evaluated for residential postapplication
exposure and risk; and therefore, a separate recreational exposure
assessment was not conducted.

Spray drift is always a potential source of exposure to residents near
spraying operations.  This is particularly the case with aerial
applications, but, to a lesser extent, could also be a potential source
of exposure from ground application methods.  As indicated in this
assessment, pyraclostrobin is directly applied to residential turf and
does not result in exposures of concern.  Based on this assessment, HED
believes that it is unlikely that there is a higher potential for risk
of exposure to spray drift from agricultural uses of this chemical.

6.0	Aggregate Risk Assessments and Risk Characterization  TC \l1 "6.0
Aggregate Risk Assessments and Risk Characterization

In accordance with the FQPA, HED must consider and aggregate (add)
pesticide exposures and risks from three major sources: food, drinking
water, and residential exposures.  In an aggregate assessment, exposures
from relevant sources are added together and compared to quantitative
estimates of hazard (e.g., a NOAEL or PAD), or the risks themselves can
be aggregated.  When aggregating exposures from various sources, HED
considers both the route and duration of exposure.  Common effects
(i.e., decreased body weight gain, food intake, and food efficiency)
were seen in the studies selected to evaluate dietary, dermal and
incidental oral ingestion exposures; and therefore, route-specific
exposures can be aggregated.

Based on the proposed Section 3 food crop uses, aggregate assessments
are required for acute and chronic dietary exposures (food + drinking
water), and existing short-/intermediate-term residential exposures
(i.e., chronic dietary, plus incidental oral and dermal exposures for
kids, and chronic dietary, plus dermal exposures for adults).  Both
short- and intermediate-term exposures may occur during postapplication
activities for adults and children.  However, because the toxicity
endpoints and points of departure are identical for short- and
intermediate-term exposures, separate risk estimates for short- and
intermediate-term exposures were not calculated.

To assess aggregate acute and chronic dietary risks, estimates of
pesticide residues in drinking water (EDWCs) were incorporated directly
into the dietary exposure analysis.  Refer to section 4.2 for these risk
estimates.

The short-/intermediate-term aggregate risk assessment takes into
account average exposure estimates from dietary consumption of
pyraclostrobin (food and drinking water) and
non-occupational/residential uses (turf).  Postapplication exposures
from the use on turf are considered predominantly short-term (1-30
days).  To calculate the short-/intermediate-term aggregate risk
estimates, the chronic dietary exposure (food + drinking water) is added
to the residential exposures using the inverse MOE methodology described
below (see Table 10 below).  The total combined MOE from dietary (food +
water) and non-occupational/residential exposure is 100 for children 1-2
years old, which is not of concern to HED.  For adults the total
combined MOE is 170, which also is not of concern to HED.  These
aggregate exposure risk assessments are considered conservative
estimates, that should not underestimate risks, because of the following
inputs: 1) dietary inputs primarily used tolerance level residues; 2)
crop specific (turf) screening level drinking water modeling data were
used (i.e., Tier II surface water model); 3) maximum application rates
and minimum application intervals were used; and 4) conservative SOPs
and upper level estimates of exposure were employed.

Table 10.  Short-/Intermediate Term Aggregate Risk Calculations

Population

Dermal Exposure

Residential Exposure

Total Combined MOE2

NOAEL

mg/kg/day

Exposure

mg/kg/day

MOE1

NOAEL mg/kg/day

Incidental Oral Exposure mg/kg/day 	Chronic Dietary (Food + Water)
mg/kg/day

MOE1

Kids 1-2 yrs

5

0.027

180

5.8

0.009425

0.0162

230

100

Adults

5

0.019

260

3.4

NA

0.0066

520

170

1 The Level of Concern MOE is 100.

2 Total Combined MOE = 1/ [(1/MOEDermal) + (1/MOEResidential)]

7.0	Cumulative Risk Characterization/Assessment  TC \l1 "7.0	Cumulative
Risk Characterization/Assessment

Unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, EPA has not made a
common mechanism of toxicity finding as to pyraclostrobin and any other
substances and pyraclostrobin does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that pyraclostrobin has
a common mechanism of toxicity with other substances. For information
regarding EPA’s efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA’s Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a common
mechanism on EPA’s website at   HYPERLINK
"http://www.epa.gov/pesticides/cumulative/"
http://www.epa.gov/pesticides/cumulative/ .

8.0	Occupational Exposure/Risk Pathway  TC \l1 "8.0	Occupational
Exposure/Risk Pathway

Reference: Pyraclostrobin: Occupational and Residential Risk Assessment
to Support Request for Section 3 Registrations on Cotton and Belgian
Endive. (DP#: 339336; PC#: 099100) J. Arthur; 05/24/07.

8.1	Short-/Intermediate-Term Handler Risk  TC \l2 "8.1
Short-/Intermediate-Term Handler Risk

Cotton (foliar)

Occupational handlers may experience short-/intermediate-term exposure
to pyraclostrobin while mixing/loading and applying sprays to cotton.
No chemical-specific handler exposure data were submitted in support of
this use pattern.  It is the policy of the HED to use data from the
Pesticide Handlers Exposure Database (PHED) Version 1.1 as presented in
PHED Surrogate Exposure Guide (8/98) to assess handler exposures when
chemical-specific monitoring data are not available ( HED Science
Advisory Council for Exposure Draft Policy # 7, dated 1/28/99).

The results of the occupational handler exposure and risk assessment for
cotton indicate that risks are not of concern with baseline clothing, or
in some cases, when gloves are used to mitigate exposure.  Exposure
assumptions and MOE estimates are summarized in Table 11.

The minimum level of PPE for handlers is based on acute toxicity for the
end-use products.  The Registration Division (RD) is responsible for
ensuring that PPE listed on the label is in compliance with the Worker
Protection Standard (WPS).

	Table 11.  Summary of  MOEs for Occupational Handlers of Pyraclostrobin
- Cotton

Exposure Scenario (Scenario #)

Dermal Unit Exposure (mg/lb ai) 1

Inhalation Unit Exposure   (mg/lb ai) 2	Application

Rate

(lb ai/A) 3	Amount Treated

(A/day) 4	Short-/Int-

term

Dermal MOE 5	Short-/Int-term Inhalation

MOE 6

Mixer/Loader

Mixing/Loading Liquid (open pour) for Groundboom application (1)	0.023
(w/gloves)	0.0012

0.20

200	2300	340

Mixing/Loading Liquid (open pour) for Aerial application (2)	0.023
(w/gloves)	0.00024

0.20

1200	390	280*

Applicator

Groundboom application (3)	0.014	0.00074

0.20	200	3800	540

Aerial application (4)	0.0050	0.000068

0.20	1200	1800	990

Flagger

Flagging for Aerial application (5) 	0.011	0.00035	0.20	350	2800	660

1 Dermal unit exposure values represent baseline clothing (long pants,
long sleeved shirts, shoes, and socks), except where the addition of
gloves is indicated.

2 Inhalation unit exposure values represent no respirator, unless
otherwise indicated.

3 Application rates are based on maximum proposed values.

4 Amount treated is the area or gallons that can be reasonably applied
in a single day for each exposure scenario of concern, based on the
application method and formulation/packaging type. (standard EPA/OPP/HED
values).

5  Short-/Intermediate-Term Dermal MOE = NOAEL (5 mg/kg/day) / Daily
Absorbed Short-/Intermediate-Term Dermal Dose.  The LOC is 100. Daily
Absorbed Dermal Dose (mg/kg/day) = [(Dermal unit exposure * 14% Dermal
absorption) * Application rate * Area treated] / 60-kg Body weight.

6  Short-/Intermediate-Term Inhalation MOE = NOAEL (0.23 mg/kg/day) /
Daily Absorbed Short-/Intermediate-Term Inhalation Dose.  Daily Absorbed
Inhalation Dose (mg/kg/day) = [(Inhalation unit exposure * 100%
absorption)] * Application rate * Area treated} / 70-kg Body weight.

* Without a respirator, this MOE would be 60, which would be of concern
to HED.

Belgian Endive

Exposure to handlers is from mixing and loading.  Application is
mechanical and, therefore, no applicator exposure is expected.  The
handler scenario assessed for the proposed uses is:

Mixing/Loading Dry Flowables for T-Jet or Similar Mechanical Spray
Equipment Attached to a Conveyor Belt (high volume/dilute application).

Equations/Calculations for Mixing and Loading

The following equations were used to estimate handler (mixer/loader)
exposure and risk:

Dermal Dose =	Rate (lb ai/gal or /lb crop) x UE (mg/lb ai) x DA x Gal or
Crop Handled per Day

(mg/kg/day)  				BW (kg)

Inhalation Dose =	 Rate (lb ai/gal or /lb crop) x UE (mg/lb ai) x Gal or
Crop Handled per Day

(mg/kg/day)				BW (kg)

Where:

Rate (Application Rate)		=	Maximum application rate on product label (lb
ai/gal or lb ai/lb fruit or root treated)

UE (Unit Exposure)		=	Exposure value taken from August 1998 PHED
Surrogate Exposure Table (mg/lb ai handled)

DA (dermal absorption factor)	=	Factor to account for dermal absorption
(14%) when endpoint is selected from an oral study.

Product or Crop Handled per Day	=	Maximum number of gallons mixed/loaded
per day (gal/day) or maximum pounds of fruit or root treated per day
(lb/day).

	BW				=	Body weight (kg)

	MOE				=	NOAEL

						Daily Dose

Application Rate

For application to roots by T-Jet on a conveyor belt, the proposed label
indicates up to 1.4 oz of product in 2.5 gallon of water per 850 lbs of
root, and up to 0.4 oz of product in approximately 3 quarts of water
applied to 10 square feet of forcing try.  See footnote to Table 15 for
unit conversions.

Unit Exposure

Baseline dermal unit of exposure represents long pants, long sleeved
shirt, no gloves, open mixing/loading.  Baseline inhalation unit
exposure represents no respiratory protection, and open mixing and
loading (PHED v. 1.1; 8/98)

Dermal and Inhalation Absorption Factors

A dermal absorption factor of 14% was determined to be appropriate and
is used because the endpoint is based on an oral study.  No inhalation
factor is needed because the endpoint is based on an inhalation study.

Product (ai) or Crop Handled per Day

HED consulted Dr. Rich Collins at California Vegetable Specialties about
the post-harvest applications to Belgian endive.  Dr. Collins indicated
that exposure to handlers is only from mixing and loading since
application is mechanical and workers are located at a distance from the
application site.  Inhalation exposure is minimal since the spray area
is in a shrouded/ enclosed area over the conveyor belt.  Dr. Collins
estimated that up to 200,000 lbs of endive roots could be treated per
day (i.e., 200forcing trays at 10 ft2 per tray.

Body Weight

Body weight is assumed to be 70 kg for inhalation exposure, but 60 kg
for dermal, because the dermal endpoint is female-specific.

Summary of Exposure/Risk

MOEs for handlers supporting postharvest applications to Belgian endive
root are all much larger than 100 with workers wearing only baseline
clothing and, therefore, are not of concern to HED.  A summary of the
exposures/risks for handlers is presented in Table 12.

Table 12  Handlers Exposures and Risks from Post-Harvest Application
of Pyraclastrobin

Exposure Scenario	Crop or Target	Application Ratea	Baseline Dermal Unit
Exposureb mg/lb ai	Baseline Inhalation Unit Exposurec mg/lb ai	Amount
Treated Dailyd	Baseline Daily Dermal Dosee mg/kg/day	Baseline Daily
Inhalation Dosef mg/kg/day	Dermal MOE g 	Inhalation MOEh

Mixing/Loading Dry Flowables For T-jet or Similar Mechanical Spray
Equipment Attached To A Conveyor Belt

	Belgian endive roots (prior to cold storage)	0.000013

lb ai/root	0.066	0.00077	200,000 lb root	0.0004	0.000029	13,000	8,000

	Belgian endive roots (in forcing trays)	0.00032

lb ai/sq ft forcing tray	0.066	0.00077	2,400

sq ft	0.00011	0.0000082	51,000	33,000

a.	1.4 oz * 12.8% of formulation product is active ingredient = 0.179 oz
ai per 850 lbs roots

0.179 oz ai/850 lbs root * 1 lb/16 oz = 0.0000132 lb ai/lb root.

0.4 oz * 12.8% of formulated product is active ingredient = 0.05 oz of
ai per 10 ft2 of forcing tray

0.05 oz/10 ft2 * 1 lb/16 oz = 0.00032 lb ai/ft2 of forcing tray

b.	Baseline Dermal Unit Exposure represents long pants, long sleeved
shirt, no gloves, open mixing/loading.  Source: PHED Version1.1, August,
1998.

c.	Baseline Inhalation Exposure represents no respiratory protection,
open mixing/loading.  Source: PHED Version1.1, August, 1998.

d.	Daily amount treated values are from experts' estimates of gallons of
spray that would be mixed/loaded in a day or pounds of root that would
be treated in a day.

e.	Daily dermal dose (mg/kg/day) = [unit dermal exposure (mg/lb ai) *
dermal absorption (0.14) * application rate (lb ai/gal or lb ai/lb
fruit) * daily amount treated / body weight (60 kg)].

f.	Daily inhalation dose (mg/kg/day) = [unit inhalation exposure (mg/lb
ai) * inhalation absorption (100%) * application rate (lb ai/gal or lb
ai/lb fruit) * daily amount treated / body weight (70 kg)].

g.	Dermal MOE = Dermal NOAEL (5 mg/kg/day)/ dermal daily dose
(mg/kg/day)

h.	Inhalation MOE = Inhalation NOAEL (0.23 mg/kg/day)/ inhalation daily
dose (mg/kg/day).

8.2	Short-/Intermediate-/Long-Term Postapplication Risk  TC \l2 "8.2
Short-/Intermediate-/Long-Term Postapplication Risk

Cotton (foliar)

This Section 3 action for pyraclostrobin involves foliar applications to
cotton.  Therefore, postapplication exposure is possible for workers
entering treated fields.  Chemical-specific dislodgeable foliar residue
(DFR) data have previously been submitted by the registrant to support
earlier registration requests for food crops.  The studies were
conducted on peaches, peanuts, strawberries and grapes (MRID #’s:
45118727, 45118724, 45118726, and 45118728, respectively), and one study
comparing the effect of two different formulations of pyraclostrobin on
grape DFR (MRID#: 45118729).  An overview of each study was provided in
a previous assessment (D269670, K. O’Rourke, 9/30/2002); a summary of
the results is provided in Table 13.

The DFR data were used to estimate restricted entry intervals (REIs) by
extrapolating, where possible, to cotton.  It was found that the type of
formulation used influences the DFR profile; therefore, only DFR values
for the emulsifiable concentrate formulation (i.e., the Headline®
fungicide formulation) were considered.  An average percent initial DFR
value was calculated (i.e., 18%) and used to estimate surrogate residue
values, and an average daily dissipation rate was estimated (i.e., 13%)
based on the individual daily dissipation rates.  Although uncertainties
are introduced into the assessment when crop-specific residues are used
to estimate residues for other types of crops, it is believed to be more
realistic than using default assumptions.

In addition to these residue data, transfer coefficients (Tc) are used
to relate the foliage residue values to activity patterns (e.g.,
scouting) to estimate potential human exposure.  The transfer
coefficients used in this assessment are from an interim transfer
coefficient policy developed by HED’s Science Advisory Council for
Exposure using proprietary data from the Agricultural Re-entry Task
Force (ARTF) database (policy # 3.1).

The estimated short-/intermediate-term MOEs are presented in Table 14.
The results of the postapplication exposure and risk assessment indicate
that MOEs of 100 are achieved on Day 0 for all cotton scenarios and,
therefore, are not of concern.

The pyraclostrobin technical material has been classified in Toxicity
Category III for acute dermal, primary eye irritation, and primary skin
irritation.  Per the Worker Protection Standard (WPS), a 12-hr
restricted entry interval (REI) is required for chemicals classified
under Toxicity Category III or IV.

Table 13.  Summary of DFR Study Results

Crop

Location

(state)

Formu-lation

Application Rate

(lb ai/A)

Number

of Apps.

Interval

r2

Initial DFR

(% of

Appl. Rate)

Dissipation

(% per day)

Half-life (days)

peaches

CA

WDG

0.12

5

7 days

0.84

22

2

27.8

peaches

GA

WDG

0.12

5

7 days

0.97

15

11

6

peaches

PA

WDG

0.12

5

7 days

0.94

22

9

7.7

Peaches Average

20

7

strawberries

NC

WDG

0.18

5

7 days

0.77

26

15

4.2

strawberries

CA

WDG

0.18

5

7 days

0.98

25

15

4.4

strawberries

OR

WDG

0.18

5

7 days

0.91

12

13

4.9

      Strawberry Average

21

14

peanuts

NC

EC

0.25

5

14 days

0.91

18

26

2.3

peanuts

GA

EC

0.25

5

14 days

0.77

17

61*

0.74

peanuts

TX

EC

0.25

5

14 days

0.91

18

24

2.5

  Peanuts Average

18

25*

grapes

CA

WDG

0.18

3

14 days

0.97

22

6

11.1

grapes

WA

WDG

0.18

3

14 days

0.94

25

6

11.8

grapes

PA

WDG

0.18

3

14 days

0.82

14

4

15.6

      Grapes WDG Average

20

5

grapes

CA

EC

0.18

3

14 days

0.95

14

9

7.4

grapes

WA

EC

0.18

3

14 days

0.9

22

9

7.5

grapes

PA

EC

0.18

3

14 days

0.79

12

5

13.9

grapes

CA

EC

0.15

6

10 days

0.9

6

6

12

grapes

NY

EC

0.15

6

10 days

0.92

28

6

11.2

grapes

WA

EC

0.15

6

10 days

0.9

24

4

17.3

      Grapes EC Average

18

7

EC Average

18

13

    WDG Average

20

9

WDG = water dispersible granule

EC = emulsifiable concentrate

* The results from the Georgia site reflect uncharacteristically high
rainfall during the monitoring period.  This is not representative of
typical conditions, therefore, the dissipation from this site was not
included in the average.

Table 14.  Summary of Estimated Postapplication Risks (Cotton)

Crop

Studies used

to Estimate

DFR 	DAT 1	DFR 2

(μg/cm2)	TC 3

(cm2/hr)	Activity

Short-/Int-

Term MOE 4

Cotton	EC average from peanut and grape studies	0	0.39	100	Irrigation,
scouting, hand weeding (low foliage)	6800

1500	Irrigation, scouting, hand weeding (full foliage)	450

2500	Hand harvesting*	270

1 DAT = Days after treatment needed to reach the LOC of 100; DAT 0 = day
of treatment, after sprays have dried; assumed to be approximately 12
hours.

2 DFR (ug/cm2) = Application rate (0.2 lb ai/A) x CF (4.54E+8 ug/lb) x
CF (2.47E-8 A/cm2) x Initial Fraction of ai Retained on the Foliage (18%
from Table 13) x [(1- Fraction of Residue That Dissipates Daily - see
Table 5) Postapplication day].

3 TC (cm2/hr) = transfer coefficients and associated activities from
ExpoSAC Policy Memo #003.1 “Agricultural Transfer Coefficients”,
8/17/2000.

4 MOE = MOE on the corresponding DAT.  MOE = NOAEL / Daily Dose.

Daily Dose = [(DFR x TC x 14% Dermal absorption x 8-hr Exposure Time)] /
[(CF: 1000 ug/mg) x (60-kg BW for Short-/Int-term)]

Short-/intermediate-term NOAEL = 5 mg/kg/day.  The LOC is 100.

* Most cotton is expected to be mechanically harvested.  Only minimal
hand-harvesting is expected.

Belgian Endive

HED has determined that there is potential exposure to persons handling
Belgian endive roots after post-harvest application is complete.  No
chemical-specific data were submitted to assess the postapplication
exposure to Belgian endive roots treated with pyraclostrobin.
Therefore, HED used surrogate data and default assumptions.

HED consulted Dr. Rich Collins at California Vegetable Specialties about
postapplication exposures following post-harvest applications to Belgian
endive roots.  He indicated that there is no dermal contact from moving
storage bins into cold storage; bins were moved with a forklift.  Also,
roots flow directly on the conveyor belt into the cold storage bins with
no dermal contact in  that process either.  Dr. Collins indicated that
there is the potential for exposure to workers planting the roots into
forcing trays (anywhere from one week to 11-12 months after treatment).
HED also consulted Dr. Stephen Flanagan in the IR-4 Western Region
office who indicated that there is potential dermal contact by
postapplication workers with the treated endive roots or the
recirculating water when:

closing the fruit bins before cold storage,

moving the forcing trays into forcing rooms,

contact with recirculating water pumped through forcing trays,

contact with endive (roots) during growth check by management,

cutting/harvesting endive (27 days after forcing), and

packing harvested endive.

As a worse-case post-application exposure scenario, HED assessed the
long-term dermal exposure of workers hand-packing individual treated
roots into forcing trays. This exposure was assessed for long-term
duration, because the operation occurs on a continuous basis throughout
the entire year.  The estimated exposure/risk is considered high end
because it is based on the assumption that contact with roots occurs on
the same day as treatment.  In reality, the pyraclostrobin residue on
the roots is likely to have dissipated by some percentage over the week
to 12 months between treatment and when the packing activity actually
occurs.

Equations and Calculations for Postapplication Dermal Exposure

The following equation was used to estimate postapplication exposure and
risk:

Dermal Dose (mg/kg/day)	=	DR0 (μg/cm2) x Tc (cm2/hr) x DA x ET (hrs)

BW (kg)

Where:

DR0	=	dislodgeable residue (on the root) on day “0” (μg/cm2)

Tc	=	transfer coefficient (1500 cm2/hr) for handling treated root
estimated using Nigg et.

al. (1984) study described below.

DA	=	dermal absorption factor (0.14)

ET	=	exposure time (2 hr/day)

BW	=	body weight (60 kg)

Dislodgeable Residue at Day Zero

(μg/cm2)		 =	AR x F x CF

Where:

Application Rate	(AR)	=	application rate (lb ai/cm2)

Fraction Retained	 (F)	=	fraction of ai retained on root is 20%
(unitless)

Conversion Factor (CF)	=	conversion factor to convert lbs ai in the
application rate to mg for the

DR0 value (4.54E5 mg/lb)

Application Rate: Convert application rate from oz ai/lbs of root, to lb
ai/cm2

The application rate can be expressed as 0.000013 lb ai/lb of root (see
Table 4).

The number of roots per pound was determined by dividing the number of
grams in a pound (454 gm) by the average weight of a Belgian endive
root, (obtained via personal communication with Dr. Rich Collins of
California Vegetable Specialties).

454 gm/1lb * 1 root/156 gm = 2.9 roots per pound

The rate of active ingredient (lb ai) per root was determined by
dividing the rate of pyraclostrobin per pound of root by the number of
roots per pound.

0.000013 lb ai/1 lb root * 1 lb root/2.9 roots = 0.0000045 lb ai/root

2πr2 + 2πrH).  The dimensions of a Belgian endive root are 5.5 inches
height (14 cm) and 1.5 inches in diameter (3.8 cm) (personal
communication with R. Collins).

Surface area of one root = 2π(1.92)2 + 2π(1.9)(14) = 189 cm2 /root

The amount of active ingredient per square centimeter (lb ai/cm2) was
determined by dividing the amount of active ingredient per root by the
surface area of one root.

0.0000045 lb ai/root * 1 root/189 cm2 = 0.000000024 lb ai/cm2

Transfer Coefficient (Tc)

HED used the following study to estimate a transfer coefficient for
determining postapplication exposures following post-harvest
applications to Belgian endive roots:

Nigg, H.N., J.H. Stamper, and R.M. Queen (1984) The Development and Use
of a Universal Model to Predict Tree Crop Harvester Pesticide Exposure.
Am. Ind. Hygiene. Association Journal 45:182-186.

This study examined dislodgeable foliar residue (DFR) of chlorbenzilate
on Valencia orange trees. This study was used to calculate dermal hand
transfer coefficients and exposures of ten harvesters. The pesticide was
applied by airblast at the maximum label rate of 2.5 lbs ai per acre in
200 gallons of water.  The ten harvesters wore cotton shirts with
exposure pads pinned inside on shoulders, chest, back, both forearms,
and both upper arms.  Thigh and shin pads were taped outside the working
clothing.  Hand exposures were monitored by hand rinse with 95 percent
ethanol.  Only the handwash data were used for the estimation of the
chemical exposure to sorters and packers on an assembly line.
Dislodgeable foliar and fruit residues were collected on days 1, 2, 3,
4, and 7 after treatment.  The dislodgeable residues on fruit remained
fairly constant on days 1 to 3, followed by a large decrease on day 4.
Exposure data were only presented for days 2, 3, and 4.  Data from days
2 and 3 only, were used for estimation of pyraclostrobin exposure.  The
exposures of the hands are presented in Table 18.  Data presented in
Table 15 are taken from the Occupational and Residential Exposure
Assessment and Recommendations for the Reregistration Eligibility
Decision Document for Imazalil (D250163, 263162).

ting Exposures (μg/hr)

Replicate	1	2	3	4	5	6	7	8	9	10	Total	Mean

2nd day	40	58	227	37	85	210	953	33	159	54	186	185

3rd day	169	98	170	39	42	1050	71	70	89	183	183

The following assumptions and equations were used to determine a
transfer coefficient for post-application exposure:

Transfer coefficients for the hands only:

Dislodgeable residues for the 2nd day was 0.103μg/cm2

Dislodgeable residues for the 3rd day was 0.129 μg/cm2

Average dislodgeable residue for two days = 0.12 μg/cm2

Transfer Coefficient (Tc) cm2/hr =	185 μg/hr / 0.12 μg/cm2 = 1500
cm2/hr

Summary of Exposure/Risk

Table 16 summarizes the estimated long-term dermal exposure/risk to
workers handling Belgian endive roots treated with pyraclostrobin.  The
dermal MOE calculated for postapplication activities is 60.  Because the
level of concern is for MOEs <100, this risk is of concern to HED.

Because exposure from the assessed activity is primarily to the hands,
the addition of chemical-resistant gloves should reduce exposure by 90%
(i.e., the absorbed dermal dose would become 0.0061 mg/kg/day), and the
resulting MOE = 610; a risk that is not of concern to HED.  This latter
activity is viewed by HED as a secondary “handler” activity, and
therefore the label should include the aforementioned glove
requirements.

Table 16. Postapplication Long-term Dermal Exposures and Risks for
Pyraclostrobin on Belgian Endive Roots

Fruit	Application Ratea

	Transfer Coefficient

(cm2/hr)	Default Transferable Residue

(day 0)	Conversion Factor (mg/lb)	Dermal Absorption (%)	Exposure Time

(hours)	Absorbed Dermal Doseb (mg/kg/day)	Long-term Dermal MOEc

Belgian endive root prior to cold storage	2.4E-8 lb ai/cm2	1,500	20%
4.5E+05	14%	8	0.061	60

a.	Application rate = lb ai/cm2 of root

b.	Absorbed dermal dose = application rate x 20% x 1500 x 4.5E+5 x 14% x
8 hours) / 60 kg body weight

c.	Dermal MOE = Long-term dermal NOAEL (3.7 mg/kg/d) / absorbed dermal
dose.  UF = 100.

9.0	Data Needs and Label Recommendations  TC \l1 "9.0	Data Needs and
Label Requirements

9.1	Residue Chemistry Data Needs and Label Recommendations  TC \l2 "9.1
Residue Chemistry Data Needs and Label Recommendations

For the proposed use on Belgian endive the following are needed if IR4
chooses to pursue a Section 3 registration:

Use directions in Section B must match the application method used in
Section D for residue data collection;

The tolerance proposal in Section F must be supported by the application
method used in Section D for residue data collection; and

Additional residue data that adequately reflect the use directions in
Section B must be submitted. (HED recommends that the petitioner submit
a protocol for HED review and comments before any residue data
collection begins.)

HED recommends that the label rate be revised to clearly define the
amounts to be used per application and the total per season.  In
addition, the petitioner should define how the spray is applied to the
roots in the forcing trays (.i.e., trays are stationary or are moving on
a conveyor belt).  A revised Section B must be submitted to adequately
reflect the petitioner’s intentions as to application rates and
directions.  Additionally, HED suggests that the application rates
should be set on a unit basis; i.e., for applications prior to cold
storage the label should indicate an amount of active ingredient per 100
lbs of roots, and for applications prior to forcing the label should
indicate an amount of active ingredient per 1 square foot of forcing
tray.

9.2	Occupational and Residential Exposure  TC \l2 "9.2	Occupational and
Residential Exposure

For the proposed use on Belgian endive, if IR4 chooses to pursue a
Section 3 registration, then the label should include a requirement for
chemical-resistant gloves.

10.0	Tolerance Summary  TC \l1 "10.0	Tolerance Summary

The tolerance expression for pyraclostrobin in plant commodities include
pyraclostrobin and its desmethoxy metabolite, and the residues of
concern in livestock commodities include pyraclostrobin and its
metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol (BF 500-5)
and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol (BF 500-8).

Tolerances for plant commodities are currently established for the
combined residues of pyraclostrobin and BF 500-3, expressed as parent,
in plant commodities at levels ranging from 0.02 ppm in/on wheat grain
to 29 ppm in/on leafy vegetables, except Brassica [40 CFR
§180.582(a)(1)].  Tolerances for livestock commodities are established
for the combined residues of pyraclostrobin and its metabolites
convertible to BF 500-5 or BF 500-8, each expressed as parent, at levels
ranging from 0.1 ppm in milk, meat, and fat to 1.5 ppm in liver of
cattle, goats, hogs, horses, and sheep [40 CFR §180.582(a)(2)].  No
tolerances are established for poultry commodities.

The tolerances proposed by BASF and IR-4 for the current petitions are
listed in Table 7, along with the Agency’s recommended tolerance
levels.  As the majority of cottonseed samples from the cotton field
trials had residues below the combined LOQ (0.04 ppm), the recommended
tolerance level for undelinted seeds were not determined using the
Tolerance/MRL Harmonization Spreadsheet.  Rather, the recommended
tolerance of 0.3 ppm is based on the maximum combined residues observed
in seeds (0.17 ppm).  Tolerances for Belgian endive, cotton gin
byproducts and the berries crop group were both determined using the
Tolerance/MRL Harmonization Spreadsheet as combined residues were
readily quantifiable in these commodities.  For the berries crop group,
residue values from both the earlier and new berry field trials were
used to calculate the appropriate tolerance, and the data from
raspberries and blueberries were pooled as residue levels were similar
on both types of berries.  The residue datasets used for the tolerance
calculations and the supporting spreadsheet outputs are presented in
Appendix II.  The calculated tolerances were 30 ppm for cotton gin
byproducts and 4.0 ppm for the berries crop group.

Results from the requested mustard greens field trials and the
supplemental field trials on cucurbit vegetables, fruiting vegetables,
grape, sunflower, and mint indicate that no changes are necessary in the
existing tolerances for these crops.  For each crop, the combined
residues in the new field trials were below the established tolerances.

With regards to the current tolerances for livestock commodities, the
existing tolerances are adequate for milk, meat, fat, meat byproducts
(except liver), and liver of cattle, goats, horses, and sheep, and the
current tolerances for liver could be lowered to 1.0 ppm.  Also, the
existing tolerances for hog commodities can be deleted as quantifiable
residues are unlikely to occur in hogs [40 CFR §180.6(a)(2)] based on
the dietary burden proposed in Table 6.  As stated previously,
tolerances are still not required for poultry commodities.

Table 17. 	Tolerance Summary for Pyraclostrobin.

Commodity	Established/Proposed Tolerance (ppm)	Recommended Tolerance
(ppm)	Comments; Correct Commodity Definition

Belgian endive

	6	Denied	Denied, since field trial data does not support the proposed
tolerance.

Berry, group 13	1.3	4.0	Tolerance calculated using available residue
data and Tolerance/MRL Harmonization Spreadsheet.

Cotton, undelinted seed	0.4	0.3	Tolerance should be set at 0.3 ppm based
on maximum combined residues of 0.17 ppm.

Cotton, gin byproducts	30	30	Tolerance calculated using available
residue data and Tolerance/MRL Harmonization Spreadsheet.

The Codex Alimentarius Commission, Mexico and Canada have not
established any maximum residue limits (MRLs) for residues of
pyraclostrobin in or on raw agricultural commodities, although a variety
of MRLs are pending in Canada (Appendix I).  Therefore, there are no
questions of compatibility of U.S. tolerances with International MRLs at
the present time.

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:  methyl
[2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy
carbamate	Common Name:

Pyraclostrobin	( Proposed tolerances

( Reevaluated tolerance

No Codex proposal step 6 or above

(No Codex proposal step 6 or above for the crops requested 	Petition
Number: 5F7002, 5E7014

DP Barcode: 337807, 337817

Other Identifier:

Residue definition (step 8/CXL):   	JStokes/HED/RRB4

	Residue definition: Combined residues of pyraclostrobin and BF 500-3,
expressed as parent

Crop (s)1	MRL (mg/kg)	Crop(s)	Recommended Tolerance (ppm)

Cotton, undelinted seed	0.3

Cotton, gin byproducts	30

Berries, group 13	4.0

	Limits for Canada	Limits for Mexico

( No Limits

( No Limits for the crops requested	( No Limits

(  No Limits for the crops requested

Residue definition:  Cyhalothrin-lambda	Residue definition:
Lambda-cyhalothrin

Crop(s)	MRL (mg/kg)	Crop(s)	MRL (ppm)

	Notes/Special Instructions:

11.0	Appendix: Toxicity Profile  TC \l1 "11.0	Appendix: Toxicity Profile

11.1	Appendix 1.: Pyraclostrobin Toxicology Requirements and Available
Studies for Food Uses  TC \l2 "11.1	Appendix 1.: Pyraclostrobin
Toxicology Requirements and Available Studies for Food Uses

Appendix 1: Pyraclostrobin Toxicology Requirements and Available Studies
for Food Uses.

  SEQ CHAPTER \h \r 1 Test

	Technical

	Required	Satisfied

870.1100	Acute Oral Toxicity

870.1200	Acute Dermal Toxicity

870.1300	Acute Inhalation Toxicity

870.2400	Primary Eye Irritation

870.2500	Primary Dermal Irritation

870.2600	Dermal Sensitization		yes

yes

yes

yes

yes

yes	yes

yes

yes

yes

yes

yes

870.3100	Oral Subchronic (rodent)

870.3150	Oral Subchronic (dog)

870.3200	28-Day Dermal

870.3465	28-Day Inhalation		yes

yes

yes

yes	yes

yes

yes

yes

870.3700a	Developmental Toxicity (rat)

870.3700b	Developmental Toxicity (rabbit)

870.3800	Reproduction		yes

yes

yes	yes

yes

yes

870.4100a	Chronic Toxicity (rat)

870.4100b	Chronic Toxicity (dog)

870.4200a	Oncogenicity (rat)

870.4200b	Oncogenicity (mouse)		yes

yes

yes

yes	yes

yes

yes

yes

870.5100	Mutagenicity—Gene Mutation - bacterial

870.5300	Mutagenicity—Gene Mutation - mammalian

870.5375	Mutagenicity—Structural Chromosomal Aberrations

870.5395	Mutagenicity—Microneucleus - mammalian

870.5550	Mutagenicity—Unscheduled DNA - mammalian 		yes

yes

yes

yes

yes	yes

yes

yes

yes

yes

870.6100a	Acute Delayed Neurotox. (hen)

870.6100b	90-Day Neurotoxicity (hen)

870.6200a	Acute Neurotox. Screening Battery (rat)

870.6200b	90 Day Neuro. Screening Battery (rat)

870.6300	Develop. Neuro		no

no

yes

yes

no

	-

-

yes

yes

-

870.7485	General Metabolism

870.7600	Dermal Penetration		yes

yes	yes

yes

11.2	Appendix 2.: Acute Toxicity Data on Pyraclostrobin Technical  TC
\l2 "11.2	Appendix 2.: Acute Toxicity Data on Pyraclostrobin Technical

  SEQ CHAPTER \h \r 1 Appendix 2. Acute Toxicity Profile:

  SEQ CHAPTER \h \r 1 Table 1. Acute Toxicity Data on Pyraclostrobin
Technical

Study/ Species	MRID	Results	Toxicity  Category

870.1100 Acute Oral, Rats	45118302	LD50 = > 5000 mg/kg	IV

870.1200 Acute Dermal, Rabbits	45118305	LD50 = >2000mg/kg	III

870.1300 Acute Inhalation, Rats	45118308	0.31 mg/L < LC50 < 1.07 mg/L	II

870.2400 Primary Eye Irritation, Rabbits	45118311	Moderate eye
irritation; MAS 4.6/110	III

870.2500 Primary Skin Irritation, Rabbits	45118314	Moderate skin
irritation; MAS 2.2/8.0	III

870.2600 Dermal Sensitization, Guinea pig	45118317	Not a skin sensitizer
N/A

11.3	Appendix 3.: Subchronic, Chronic and Other Toxicity Profile  TC
\l2 "11.3	Appendix 3.: Subchronic, Chronic and Other Toxicity Profile

  SEQ CHAPTER \h \r 1 Appendix 3. Subchronic, Chronic and Other Toxicity
Profile

Guideline No./Study Type	MRID No. (year)/ Classification/Doses	Results

870.3100

90-Day oral toxicity (rat)	45118321 (1999)

Acceptable/guideline

0, 50, 150, 500, 1000, 1500 ppm

M: 0, 3.5, 10.7, 34.7, 68.8, 105.8 mg/kg/day;

F: 0, 4.2 12.6, 40.8, 79.7,118.9  mg/kg/day	NOAEL = 10.7 mg/kg/day

 mg/kg/day based on ↓body weight/ weight gain in males, ↓food intake
(both sexes), ↑ relative liver wt and spleen wt in females and
histopathology of duodenum and liver in males, and spleen in both sexes.

870.3100

90-Day oral toxicity

(mouse)	45118320 (1999)

Acceptable/guideline

0, 50, 150, 500, 1000, 1500 ppm

M: 0, 9.2, 30.4, 119.4, 274.4, 475.5 mg/kg/day

F:0, 12.9, 40.4, 162.0, 374.1, 634.8 mg/kg/day	NOAEL = 9.2 mg/kg/day

LOAEL =  30.4 mg/kg/day based on ↓body weight/ weight gain in males,
changes in clinical chemistry in both sexes (increased urea and
decreased triglycerides), and increased incidences in females of lymph
node apoptosis, thymus atrophy, and ulcer/erosion in the glandular
stomach.

870.3150

90-Day oral toxicity (dog)	45118323 (1999)

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㠮⸵ⰸㄠ⸲‹杭欯⽧慤൹㩆〠⸳ⰰ㘠㈮㌱㘮洠⽧
杫搯祡万䅏䱅㴠㔠㠮洠⽧杫搯祡

LOAEL = 12.9 mg/kg/day based on ↑diarrhea, clinical chem. changes, and
increased incidence of thickening/ mucosal hypertrophy of the duodenum
in both sexes; body weight loss, and ↓food intake/efficiency in
females.

870.3050

28-Day oral toxicity (rat)

	MRID 45118322 (1999)

Acceptable/guideline

0, 20, 100, 500, 1500 ppm

M: 0, 1.8, 9.0, 42.3, 120.2 mg/kg/day

F: 0, 2.0 9.6, 46.6, 126.3  mg/kg/day	NOAEL =  9.0 mg/kg/day

LOAEL = 42.3 mg/kg/day based on changes in hematology parameters,
increased absolute and relative spleen weight, histopathology in spleen
and liver, in addition to increased duodenal mucosal hyperplasia in both
sexes.

870.3200

28-Day dermal toxicity (rat)	45118324 (1999) Unacceptable/guideline (a
higher dose could be tolerated and the limit dose is 1000 mg/kg/day)

0, 40, 100, 250 mg/kg for 5 days/wk	Dermal NOAEL = 40 mg/kg/day

Dermal LOAEL = 100 mg/kg/day based on scale formation, hyperkeratosis,
and epidermal thickening.

Systemic NOAEL = 250 mg/kg/day

Systemic LOAEL > 250 mg/kg/day

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the dermal study.

870.3465

28-Day inhalation toxicity (rat)	46638801 (2005)

Acceptable/guideline

0.001, 0.030, or 0.300 mg/L for 6 hours per day, 5 days/week (20
exposure days) – Test substance was dissolved in acetone and
administered as an aerosol	Inhalation NOAEL = 0.001 mg/L (oral
equivalent dose = 0.23 mg/kg/day)

Inhalation LOAEL = 0.030 mg/L (oral equivalent dose = 6.9 mg/kg/day)
based on findings of hyperplasia in the duodenum, alveolar histiocytosis
in the lungs, and olfactory atrophy/necrosis in the nasal tissues.

870.3700a

Prenatal developmental (rat)	45118325 (1999)

Acceptable/guideline

0, 10, 25, 50 mg/kg/day	Maternal NOAEL = 10 mg/kg/day

LOAEL = 25 mg/kg/day based on ↓body wt/ wt gain and ↓food
intake/efficiency.

Developmental NOAEL = 25 mg/kg/day

LOAEL = 50 mg/kg/day based on ↑ incidences of dilated renal pelvis and
cervical ribs with no cartilage.

870.3700b

Prenatal developmental (rabbit)	45118326 and 45437001 (1999)
Acceptable/guideline

0, 1, 3, 5, 10, 20 mg/kg/day	Maternal NOAEL = 5 mg/kg/day

LOAEL = 10 mg/kg/day based on ↓ body wt gain and ↓food
intake/efficiency.

Developmental NOAEL = 5 mg/kg/day

LOAEL =10 mg/kg/day based on ↑ resorption/post-implantation loss.

870.3800

Reproduction and fertility effects

(rat)	Two Generation: MRID 45118327 (1999) Acceptable/guideline when
combined with the one generation preliminary study (below)

0, 25, 75, 300 ppm

F0 M/F: 0, 2.5/2.6, 7.4/7.8, 29.0/30.4 mg/kg/day

F1 M/F: 0, 2.8/3.0, 8.6/9.0, 35.0/36.0 mg/kg/day

One Generation: MRID 45596210 (2002)

0, 200, 400, 600 ppm

F0 M/F: 0, 20.5/21.3, 39.9/42.5, 59.1/60.4 mg/kg/day	Parental/Systemic
NOAEL = 29 mg/kg/day

LOAEL > 29 mg/kg/day based on no effects.

Reproductive NOAEL = 29 mg/kg/day

LOAEL > 29 mg/kg/day based on no effects.

Offspring NOAEL =  29 mg/kg/day

LOAEL > 29  mg/kg/day based on no effects.

Offspring NOAEL < 20.5 mg/kg/day

Offspring LOAEL = 20.5 mg/kg/day based on decreased pup body weight and
body weight gain on and after post-natal day 7.

870.4100a

Chronic toxicity

(rat)	45118329 (1999) Unacceptable/guideline

0, 25, 75, 200 ppm

M: 0, 1.1, 3.4, 9.0 mg/kg/day

F: 0, 1.5, 4.6, 12.3 mg/kg/day	NOAEL =  9.0 mg/kg/day

LOAEL > 9.0 mg/kg/day.

870.4100b

Chronic toxicity (dog)	45118328 (1999)

Acceptable/guideline

0, 100, 200, 400 ppm

M: 0, 2.7, 5.4, 10.8 mg/kg/day

F: 0, 2.7, 5.4, 11.2 mg/kg/day	NOAEL = 5.4 mg/kg/day

LOAEL = 10.8 mg/kg/day based on ↑ diarrhea and clinical chemistry
changes in both sexes (decreased cholesterol, protein, albumin, and
globulin), and ↓ body weight gain and ↓food intake/efficiency in
females.

870.4200

Carcinogenicity

(rat)	45118331 (1999)

Acceptable/guideline

0, 25, 75, 200 ppm

M: 0, 1.2, 3.4, 9.2 mg/kg/day

F: 0, 1.5, 4.7, 12.6 mg/kg/day	NOAEL = 3.4 mg/kg/day

LOAEL =  9.2 mg/kg/day based on ↓ body weight and body weight gain,
and kidney atrophy/tubular casts in both sexes; hepatic necrosis and
gross/ microscopic ulcerations/lesions in the glandular and
fore-stomachs in males.

No evidence of carcinogenicity

870.4300

Carcinogenicity

(mouse)	45118330 (1999) Unacceptable/guideline

M: 0, 10, 30, 120 ppm

0, 1.4, 4.1, 17.2 mg/kg/day

F: 0, 10, 30, 120, 180 ppm

0, 1.6, 4.8, 20.5, 32.8 mg/kg/day	NOAEL =  M: 4.1 mg/kg/day

	     F:  32.8 mg/kg/day

LOAEL =  M: 17.1 mg/kg/day based on decrease in body weight gain (20%)
at 13 weeks which was supported by the results of a 90-day study.

	    F >32.8 mg/kg/day

Inadequate dosing in females based on CARC Report dated 10/22/03 (TXR #
0051445)

No evidence of carcinogenicity

Gene Mutation

870.870.5100

Bacterial reverse mutation assay	45118332 (1997)

Acceptable/guideline	Negative  ± S9 up to 5,000 μg/plate by standard
plate and tube preincubation. No cytotoxicity at any dose but there was
precipitation at ≥2,500 μg/plate.

Gene Mutation

870.5300

Mammalian cell culture	45118335 (1998)

Acceptable/guideline	Negative  ± S9 up to cytotoxic and precipitating
concentration of 20 μg/mL

Cytogenetics (in vitro)

870.5375 Chromosomal aberrations	45118333 (1999)

Acceptable/guideline	Negative ± S9 for clastogenic/aneugenic activity
up to 25 μg/mL.  Precipitation and cytotoxicity (reduced cell
attachment and poor quality of metaphases) were seen at concentrations
≥50  μg/mL.

Cytogenetics

870.5395

Micronucleus test in mouse	45118334 (1998)

Acceptable/guideline	Negative for clastogenic/aneugenic activity up to
the highest dose tested (300 mg/kg).  In a preliminary study, doses
≥400 mg/kg caused death.

Unscheduled DNA synthesis

870.5550

Rat hepatocyte culture	45118336 (1998)

Acceptable/guideline	Negative up to a cytotoxic concentration of 1.0
µg/mL.

870.6200a

Acute neurotoxicity screening (rat)	45118337(1999)

Acceptable/guideline

0, 100, 300, 1000 mg/kg	Neurotoxicity NOAEL = 1000 mg/kg

M/F LOAEL >1000 mg/kg

Systemic M/F NOAEL = 300/〱〰洠⽧杫

㐀ۖĀ̊dਃ昀Ĵ瑹ྷí଀M/F LOAEL 1000/ >1000 mg/kg based on
↓body weight gain in males.

870.6200b

Subchronic neurotoxicity screening (rat)	45118401 (1999)

Acceptable/guideline

0, 50, 250, 750 (M)/1500 (F) ppm

M: 0, 3.5, 16.9, 49.9 mg/kg/day

F: 0, 4.0, 20.4, 111.9 mg/kg/day	Neurotoxicity M/F NOAEL =  49.9/111.9
mg/kg/day

M/F LOAEL  >49.9/111.9 mg/kg/day.

Systemic M/F NOAEL =  16.9/20.4 mg/kg/day

M/F LOAEL =  49.9/111.9 mg/kg/day based on ↓ body weight gain, and ↓
food intake/efficiency.

870.7485

Metabolism and pharmacokinetics

(rat)	 45118403 (1998)

 45118404 (1999)

Acceptable/guideline	Nearly 35% of an oral dose of pyraclostrobin is
absorbed with urinary and fecal excretions accounting for about 15% and
85%, respectively, and bile elimination accounted for about 30%. Two
peak plasma concentrations were reached at 0.5-1 and 8 hours with lower
plasma concentrations in males than females (by 16-38%) during the early
peak phase.  Elimination was biphasic at a low dose with plasma half
lives of nearly 10/35 hours and monophasic at a high dose with a
half-life of nearly 20 hours.  Tissue distribution was fast, peaking at
0.5 hours, and was slightly higher among females.  Some of the highest
concentrations were found in the liver, thyroid, kidney, lung, adrenal
glands, and pancreas but all levels dropped by more than 20-fold within
72 hours. About 33 metabolites were identified in urine, feces, and bile
with no sex- or dose-related differences but the position of the label
seemed to alter the profile, particularly in the urine.  Desmethoxy
pyraclostrobin (500M07) is one of the major metabolites in rat and is
also found in large amounts in plants (BF 500-3) and livestock (500M07).
 The rat metabolic pathway included phase-I reactions such as
N-demethoxylation, various hydroxylations, and cleavage of the ether
bond with subsequent oxidation; these reactions were followed by phase
II glucuronidation and sulfation.

870.7600

Dermal penetration

(rat)	45118402 (1999) Unacceptable/guideline (most of the test material
was retained on the dressing and was unavailable for absorption;
therefore, actual dose cannot be determined. 	The HIARC calculated and
recommended a dermal penetration rate of 14% (report dated 2/10/03; TXR
# 0051553)

Page   PAGE  1  of   NUMPAGES  75


[Federal Register Volume 86, Number 80 (Wednesday, April 28, 2021)]
[Notices]
[Page 22401]
[FR Doc No: 2021-08829]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 4428-011]

Walden Hydro, LLC; Notice of Intent To Prepare an Environmental
Assessment

    On May 29, 2020, Enel Green Power North America, Inc.\1\ filed an
application on behalf of Walden Hydro, LLC (Walden Hydro), for a new
license for the 2.1-megawatt Walden Hydroelectric Project (Walden
Project) (FERC No. 4428). The Walden Project is located on the Wallkill
River in Orange County in the Village of Walden, New York. The Project
is located approximately 28.5 river miles upstream of the mouth of the
Wallkill River. The project does not occupy federal land.
---------------------------------------------------------------------------

    \1\ In a February 3, 2021 filing, the Commission was notified
that Enel Green Power North America, Inc. transferred all its
ownership interests for Walden Hydro, LLC to Hydroland, Inc.
---------------------------------------------------------------------------

    In accordance with the Commission's regulations, on February 10,
2021, Commission staff issued a notice that the project was ready for
environmental analysis (REA notice). Based on the information in the
record, including comments filed on the REA notice, staff does not
anticipate that licensing the project would constitute a major federal
action significantly affecting the quality of the human environment.
Therefore, staff intends to prepare an Environmental Assessment (EA) on
the application to license the Walden Project.
    The EA will be issued and circulated for review by all interested
parties. All comments filed on the EA will be analyzed by staff and
considered in the Commission's final licensing decision.
    The application will be processed according to the following
schedule. Revisions to the schedule may be made as appropriate.

------------------------------------------------------------------------
              Milestone                           Target date
------------------------------------------------------------------------
Commission issues EA August 2021 \2\.
Comments on EA.......................  September 2021.
------------------------------------------------------------------------

    Any questions regarding this notice may be directed to Samantha
Pollak at<PHONE_NUMBER> or<EMAIL_ADDRESS>---------------------------------------------------------------------------

    \2\ The Council on Environmental Quality's (CEQ) regulations
under 40 CFR 1501.10(b)(1) require that EAs be completed within 1
year of the federal action agency's decision to prepare an EA. This
notice establishes the Commission's intent to prepare an EA for the
Walden Project. Therefore, in accordance with CEQ's regulations, the
EA must be issued within 1 year of the issuance date of this notice.

    Dated: April 22, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-08829 Filed 4-27-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 5, 2010 (Volume 75, Number 150)]
[Notices]
[Page 47332-47333]
[DOCID:fr05au10-102]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62607; File No. SR-ISE-2010-80]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of a Proposed Rule Change by International Securities
Exchange, LLC That Constitutes a Stated Interpretation With Respect to
the Meaning, Administration, and Enforcement of Rule 2128

July 30, 2010.
    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 29, 2010, International Securities Exchange, LLC (the
``Exchange'' or ``ISE'') 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.
---------------------------------------------------------------------------

    \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 a rule change that constitutes a stated
interpretation with respect to the meaning, administration, and
enforcement of Rule 2128. The proposed rule change is available on the
Exchange's Web site at http://www.ise.com, at the Exchange's principal
office, and at the Public Reference Room of the Commission.

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 self-regulatory organization 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to adopt a stated interpretation with respect
to the meaning, administration, and enforcement of Rule 2128(g),
concerning the ability of an Exchange Officer to act on his or her own
motion to review potentially erroneous executions.
    Rule 2128(g) provides that an Officer, acting on his or her own
motion, may review potentially erroneous executions that occur on the
Exchange and may, among other things, declare such transaction(s) null
and void. When extraordinary circumstances exist, any such action must
be taken by no later than the start of the Regular Market Session of
the Exchange on the trading day following the date of execution(s)
under review.
    For purposes of Rule 2128(g), the Exchange believes that a series
of transactions in a particular security on one or more trading days
may be viewed as one event if all such transactions were effected based
on incorrect or grossly misinterpreted structural or issuance
information, resulting in a severe pricing dislocation for all such
transactions (the ``Event''). In such circumstances, the Event may be
considered to constitute extraordinary circumstances pursuant to Rule
2128(g).
    An Officer acting on his or her own motion may take action to
declare all transactions that occurred during the Event null and void
not later than before the start of the next trading date following the
last such transaction in the Event. If the security is halted
immediately following the last transaction in the Event, and before
pricing ceases to be dislocated, the next trading date for all
transactions comprising the Event will be the date on which trading
resumes following the halt.
    In particular, the Exchange believes that the interpretation is
applicable to a recent event involving a New York Stock Exchange LLC
(``NYSE'') offer (``NYSE Exchange Offer'') made by U.S. Bancorp in
which there were a series of executions based on incorrect or grossly
misinterpreted structural or issuance information, as a result of which
the securities traded at severely dislocated prices.
    In May 2010, U.S. Bancorp commenced an offer to exchange up to
1,250,000 Depositary Shares, each representing a 1/100 the interest in
a share of Series A Non-Cumulative Perpetual Preferred Stock, $100,000
liquidation preference per share (the ``Depositary Shares'') for any
and all of the 1,250,000 outstanding 6.189% Fixed-to-Floating Rate
Normal ITS issued by U.S. Bancorp Capital IX, each with a liquidation
amount of $1,000 (the ``Normal ITS''). The Depositary Shares were
approved for listing on the NYSE under the symbol USB PRA. On June 11,
2010, the NYSE opened the shares on a quote, but trading did not
commence until June 16, 2010 at prices in the range of $85.00 per
share. There were additional executions on the ISE Stock Exchange in
the $79.00 to $85.00 price range on June 17 and 18, 2010.
    On June 18, 2010, the NYSE halted trading in the Depositary Shares
on all markets and alerted U.S. Bancorp and other exchanges that traded
the Depositary Shares of the pricing discrepancy. For purposes of this
stated interpretation, the Exchange believes that the trading in
Depository Shares from June 16 to June 18 constituted a single event
because that trading was based on incorrect or grossly misinterpreted
structural or issuance information that resulted in severe price
dislocation (the ``U.S. Bancorp Event''). Because the Depository Shares
were halted before the price of the Depository Shares ceased to be
dislocated, and remain halted, the Exchange believes that, pursuant to
this interpretation, an Officer may review trading in Depository Shares
and may declare null and void all trading in the U.S. Bancorp Event,
provided such declaration is made before the security resumes trading
following the trading halt.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\3\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\4\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, 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. The Exchange
believes that the proposed stated interpretation promotes just and
equitable principles of trade because it ensures that a potentially
erroneous execution may be

reviewed if such executions are based on incorrect or grossly
misinterpreted structural or issuance information, resulting in a
severe pricing dislocation for all such transactions. The stated
interpretation also enables the Exchange to declare null and void such
potentially erroneous executions during a halt in trading, but before
trading resumes at a price based on the corrected information.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) \5\ of the Act and Rule 19b-4(f)(1) \6\ thereunder. At any
time within the 60-day period beginning on the date of the filing of
the proposed rule change, the Commission summarily may temporarily
suspend such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act.
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    \5\ 15 U.S.C. 78s(b)(3)(A).
    \6\ 17 CFR 240.19b-4(f)(6).
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IV. 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2010-80 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2010-80. This file
number should be included on the subject line if e-mail 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 Web site (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 Web site viewing and
printing in the Commission's Public Reference Room, on official
business days between the hours of 10 a.m. and 3 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; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-ISE-2010-80 and should be submitted on or before August
26, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-19266 Filed 8-4-10; 8:45 am]
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[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Proposed Rules]
[Pages 40618-40619]
[FR Doc No: 2020-14462]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2020-0002; FRL-10011-12-Region 8]

Determination of Attainment by the Attainment Date for the Salt
Lake City, Utah and Provo, Utah 2006 24-Hour PM2.5 Nonattainment Areas;
Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; correction.

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SUMMARY: The Environmental Protection Agency (EPA) published a proposed
rule in the Federal Register on June 8 2020, determining that the Salt
Lake City, Utah and Provo, Utah Serious PM2.5 nonattainment
areas had attained the 2006 24-hour National Ambient Air Quality
Standard (NAAQS) for PM2.5 and this document corrects
information displayed in a Table within that proposed rule.

DATES: Written comments must be received on or before August 6, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2020-0002, to the Federal Rulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
www.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 http://www2.epa.gov/dockets/commenting-epa-dockets.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov. To reduce the risk of COVID-19 transmission,
for this action we do not plan to offer hard copy review of the docket.
Please email or call the person listed in the FOR FURTHER INFORMATION
CONTACT section if you need to make alternative arrangements for access
to the docket.

FOR FURTHER INFORMATION CONTACT: Crystal Ostigaard, Air and Radiation
Division, EPA, Region 8, Mailcode 8ARD-IO, 1595 Wynkoop Street, Denver,
Colorado 80202-1129,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The EPA issued a proposed rule in the
Federal Register on June 8, 2020 (85 FR 35033). There was an error in
``Table 1'' contained within section ``II. EPA Evaluation,'' subsection
``C. Evaluation of Current Attainment'' of the June 8, 2020 proposed
rule. The table erroneously listed the 2017-2019 98th percentiles and
design value for the Spanish Fork monitor twice; one correctly within
the row for the Spanish Fork monitor and the second incorrectly within
the row for the Lindon monitor. Table 1 should have listed the 98th
percentiles and design value for the Lindon monitor as: 2017 98th
percentile--28.9 [micro]g/m\3\; 2018 98th percentile--28.4 [micro]g/
m\3\; 2019 98th percentile--21.2 [micro]g/m\3\; and 2017-2019 design
value--26 [micro]g/m\3\. This corrective action does not affect our
determination that the areas are meeting the NAAQS. This correction
document does not otherwise change the remaining portions of the June
8, 2020 notice of proposed rulemaking.

Correction

    In FR Document 2020-12074 appearing on pages 35033-35035 in the
Federal Register of Monday, June 8, 2020, the following correction is
made:
    On page 35035, in Table 1, under the heading entitled ``NAA'' in
the entry entitled ``Provo'' for ``Lindon'' monitoring site, remove the
text ``27.6'' associated with column ``98th percentile values'' and
``2017,'' and replace the text with ``28.9''; remove the text ``49.6''
associated with column ``98th percentile values'' and ``2018,'' and
replace the text with ``28.4''; remove the text ``17.5'' associated
with column ``98th percentile values'' and ``2019,'' and replace the
text with ``21.2''; remove the text ``32'' associated with column
``2017-2019 design value,'' and replace the text with ``26.'' The
complete corrected table is below:

                 Table 1--Salt Lake City and Provo NAAs 2017-2019 24-Hour PM2.5 Air Quality Data
                                                 [[micro]g/m\3\]
----------------------------------------------------------------------------------------------------------------
                                                                      98th percentile values
             NAA                 Monitor site      Monitor ID   ---------------------------------    2017-2019
                                                                    2017       2018       2019     design value
----------------------------------------------------------------------------------------------------------------
Salt Lake City...............  Bountiful.......     49-011-0004       35.2       25.7       19.3              27
                               Rose Park.......     49-035-3010       32.4       29.2       27.9              30
                               Hawthorn........     49-035-3006       35.7       26.2       27.3              30
                               Herrimam #3.....     49-035-3013       28.2       29.0       18.8              25
                               Erda............     49-045-0004       20.9       30.6       22.9              25
Provo........................  Lindon..........     49-049-4001       28.9       28.4       21.2              26
                               Spanish Fork....     49-049-5010       27.6       49.6       17.5              32
----------------------------------------------------------------------------------------------------------------

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Greenhouse gases, Incorporation by reference, Intergovernmental
relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting
and recordkeeping requirements, Sulfur oxides, Volatile organic
compounds.

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

    Dated: June 25, 2020.
Gregory Sopkin,
Regional Administrator, EPA Region 8.
[FR Doc. 2020-14462 Filed 7-6-20; 8:45 am]
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