EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

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

PP #2E8069

EPA has received a pesticide petition (2E8069) from Interregional Research 

Project Number 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ 08540

proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act 

(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish new tolerances for 

pyraclostrobin, carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-

yl]oxy]methyl]phenyl]methoxy-, methyl ester and its metabolite methyl-N-[[[1-(4-

chlorophenyl) pyrazol-3-yl]oxy]o-tolyl] carbamate (BF 500-3); expressed as parent 

compound in or on the raw agricultural commodity Artichoke, globe at 3.0 parts per 

million (ppm); Endive, Belgium at 3.0 ppm; Persimmon at 3.0 ppm; and updating 

existing crop groups to Vegetable, bulb, group 3-07 at 0.9 ppm; Vegetable, fruiting, 

group 8-10 at 1.4 ppm; Fruit, citrus, group 10-10 at 2.0 ppm; Fruit, pome, group 11-

10 at 1.5 ppm; Oilseed, group 20 at 0.45 ppm; Caneberry subgroup 13-07A at 4.0

ppm; Bushberry Subgroup 13-07B at 4.0 ppm; Small fruit, vine climbing subgroup

(except fuzzy kiwi) 13-07F at 2.0 ppm; and Low growing berry subgroup 13-07G at 

1.2 ppm; and to amend 40 CFR part 180 by removing a tolerance for residues of 

[pyraclostrobin, carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-

yl]oxy]methyl]phenyl]methoxy-, methyl ester and its metabolite methyl-N-[[[1-(4-

chlorophenyl) pyrazol-3-yl]oxy]o-tolyl] carbamate (BF 500-3); expressed as parent 

compound] in or on the raw agricultural commodity Berry, group 13 at 4.0 ppm; Fruit, 

citrus, group 10 at 2.0 ppm; Fruit, pome, group 11 at 1.5 ppm; Grape at 2.0 ppm;

Strawberry at 1.2 ppm; Vegetable, bulb, group 3 at 0.9 ppm; Vegetable, fruiting, 

group 8 at 1.4 ppm; Borage, seed at 0.45 ppm; Castor oil plant, seed at 0.45 ppm; 

Chinese tallowtree, seed at 0.45 ppm; Crambe, seed at 0.45 ppm; Cuphea, seed at 0.45 

ppm; Echium, seed at 0.45 ppm; Euphorbia, seed at 0.45 ppm; Evening primrose, 

seed at 0.45 ppm; Flax seed at 0.45 ppm; Gold of pleasure, seed at 0.45 ppm; Hare’s 

ear mustard, seed at 0.45 ppm, Jojoba, seed at 0.45 ppm; Lesquerella, seed at 0.45 

ppm, Lunaria, seed at 0.45 ppm; Meadowfoam, seed at 0.45 ppm; Milkweed, seed at 

0.45 ppm; Mustard, seed at 0.45 ppm; Niger seed, seed at 0.45 ppm; Oil radish, seed at 

0.45 ppm; Poppy, seed at 0.45 ppm; Rapeseed, seed at 0.45 ppm; Rose hip, seed at 0.45 

ppm; Safflower, seed at 0.45 ppm; Sesame, seed at 0.45 ppm; Stokes aster, seed at 0.45 

ppm; Sunflower, seed at 0.45 ppm; Sweet rocket, seed at 0.45 ppm, Tallowwood, seed

at 0.45 ppm, Tea oil plant, seed at 0.45 ppm, and Vernonia, seed at 0.45 ppm. EPA 

has determined that the petition contains data or information regarding the elements set 

forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the 

sufficiency of the submitted data at this time or whether the data supports granting of the 

petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. Plant and animal metabolism. Nature of the residue 
2

studies (OPPTS 860.1300) were conducted in grape, potato and wheat as 

representative crops in order to characterize the fate of pyraclostrobin in all crop 

matrices. Pyraclostrobin demonstrated a similar pathway and fate in all three 

crops. In all three crops the pyraclostrobin Residues of Concern (ROC) of were 

characterized as parent (pyraclostrobin) and BAS 500-3), methyl-N[[[1-(4-

chlorophenyl) pyrazol-3yl]oxy]o-tolyl] carbamate. In hens the residues of concern 

were determined to be parent compound and a hydroxlated metabolite, BAS 500-16. 

In goats the residues of concern were determined to be parent and a hydroxylated 

metabolite BAS 500-10.

2. Analytical method. In plants the method of analysis is aqueous organic 

solvent extraction, column clean up and quantitation by LC/MS/MS. In animals the 

method of analysis involves base hydrolysis, organic extraction, column clean up 

and quantitation by LC/MS/MS or derivatization (methylation) followed by 

quantitation by GC/MS.

3. Magnitude of residues. Field trials were carried out in order to determine 

the magnitude of the residues in globe artichoke, globe; endive, Blegium; and 

persimmon, to satisfy the requirements for a tolerance of pyraclostrobin in these 

commodities. Field trials were carried out using the maximum proposed labeled 

rate, maximum proposed number of applications, and the minimum proposed preharvest interval. No additional data were needed in support of residues in meat, 

milk, poultry and eggs.

 

B. Toxicological Profile

1. Acute toxicity. Pyraclostrobin and its formulated products have favorable 

acute toxicity. The acute toxicity studies place technical pyraclostrobin in toxicity 

category IV for acute oral and acute inhalation and category III for acute dermal. 

Pyraclostrobin is category III for both eye and skin irritation, and it is not a dermal 

sensitizer. Two formulated end use products are proposed, an Emulsifiable 

Concentrate (EC) and an Extruded Granule (EG). The EC has an acute oral 

toxicity category of II, acute dermal of III, acute inhalation of IV, eye and skin 

irritation categories of III, and is not a dermal sensitizer. The EG has acute oral 

and dermal toxicity categories of III, acute inhalation of IV, eye irritation of III, 

skin irritation of IV and is not a dermal sensitizer.

2. Genotoxicty. Pyraclostrobin was negative for inducing mutations in both an 

in vitro Ames test and an in vitro CHO/HGPRT Locus Mammalian Cell Mutation 

Assay. Pyraclostrobin also demonstrated no chromosomal effects in an in vitro V79 

Cells CHO Cytogenetic Assay and an in vivo Mouse Micronucleus test. An 

additional in vitro study investigating DNA damage and repair also showed no 

effects. Pyraclostrobin has been tested in a total of 5 genetic toxicology assays 

consisting of in vitro and in vivo studies. It can be stated that pyraclostrobin did not 

show any mutagenic, clastogenic or other genotoxic activity when tested under the 

conditions of the studies mentioned above. Therefore, pyraclostrobin does not pose 
3

a genotoxic hazard to humans.

3. Reproductive and developmental toxicity. The reproductive and 

developmental toxicity of pyraclostrobin was investigated in a 2-generation rat 

reproduction study as well as in rat and rabbit teratology studies. There were no 

adverse effects on reproduction, systemic toxicity to adults or developmental toxicity 

in the two-generation study so the NOAEL is the highest dose tested of 300 ppm 

(approximately 32.6 mg/kg bw/day).

No teratogenic effects were noted in either the rat or rabbit developmental studies. 

In the rat study, maternal toxicity observed at the mid and high dose consisted of 

decreased food consumption and body weight gain. Developmental changes noted 

at the high dose were increased incidences of dilated renal pelvis and cervical ribs 

with no cartilage. The maternal NOAEL was 10 mg/kg bw and the developmental 

NOAEL was 25 mg/kg bw.

In the rabbit teratology study, maternal toxicity observed at the mid and high doses 

consisted of decreased food consumption and body weight gain (severe at the high 

dose). An increased postimplantation loss was also observed at the mid and high 

doses due to an increase in early resorptions. In rabbits, these types of effects are 

often observed with significant stress on the mothers (as seen by the body weight 

gain decrease in this study) and not indicative of frank developmental toxicity. The 

NOAEL for both maternal and developmental toxicity was 5 mg/kg bw.

4. Subchronic toxicity. The subchronic toxicity of pyraclostrobin was 

investigated in 90-day feeding studies with rats, mice and dogs, and in a 28-day 

dermal administration study in rats. A 90-day neurotoxicity study in rats was also 

performed. Generally, mild toxicity was observed. At high dose levels in feeding 

studies, general findings in all three species were decreased food consumption and 

body weight gain and a thickening of the duodenum. Anemia occurred at high dose 

levels in both rats and mice with accompanying extramedullary hematopoiesis of the 

spleen in rats. In rats only, a finding of liver cell hypertrophy was indicative of a 

physiological response to the handling of the chemical. The lowest NOAEL in the 

90-day feeding studies was from the dog study and determined to be 5.8 mg/kg 

bw/day.

In the 28-day repeat dose dermal study, no systemic effects were noted up to the 

highest dose tested of 250 mg/kg bw/day. 

In a 90-day rat neurotoxicity study, a direct neurotoxic effect was not observed.

5. Chronic toxicity. Pyraclostrobin was administered to groups of 5 male and 

5 female purebred Beagle dogs in the diet at concentrations of 0, 100, 200 and 400 

ppm over a period of 12 months. Signs of toxicity were observed at the high dose. 

Diarrhea was observed throughout the study period for both sexes. High dose males 

and females initially lost weight and body weight gain was decreased for the entire 

study period for females. Hematological changes observed were an increase in 
4

white blood cells in males, and an increase in platelets in both sexes at the high dose. 

Clinical chemistry demonstrated a decrease in serum total protein, albumin, 

globulins and cholesterol in high dose animals of both sexes possibly due to the 

diarrhea and reduced nutritional status of the animals. The NOAEL was 200 ppm 

(ca. 5.5 mg/kg bw/day males; 5.4 mg/kg bw/day females).

In an oncogenicity study, pyraclostrobin was administered to groups of 50 male and 

50 female Wistar rats at dietary concentrations of 0; 25; 75, and 200 ppm for 24 

months. In a companion chronic toxicity study, 20 rats/sex were used at the same 

dose levels as in the oncogenicity study. A body weight gain depression of 10-11% 

in males and 14-22% in females with an accompanying decrease in food efficiency 

was observed at the high dose. There was no evidence that pyraclostrobin produced 

a carcinogenic effect in rats. The NOAEL for the chronic rat and the cancer rat 

study is 75 ppm (ca. 3.4 mg/kg bw/day males; 4.7 mg/kg bw/day females).

Pyraclostrobin was administered to groups of 50 male and 50 female B6C3F1 mice 

at dietary concentrations of 0, 10, 30, 120 and 180 ppm (females only) for 18 months. 

Body weights were reduced at the highest doses tested in both males and females. 

At the high dose, body weight gain decreases of 27% in females and 29% in males 

with an accompanying decrease in food efficiency were observed. No other signs of 

toxicity were noted at any dose level. The NOAEL was found to be 30 ppm (ca. 4.1 

mg/kg bw/day) for males. The Agency determined that the body weight effect at the 

high dose in females was not sufficient to determine an MTD. Therefore the 

NOAEL for females is considered greater than the highest dose tested of 32.8 mg/kg 

bw/day. There was no evidence that pyraclostrobin produced a carcinogenic effect 

in mice.

6. Animal metabolism. In a rat metabolism study with pyraclostrobin, 10-13% 

of the administered dose was excreted in the urine and 74-91% in the feces within 48 

hours. Excretion via bile was significant accounting for 35-38% of the administered 

dose. By 120 hours after dosing, very little radioactivity remained in tissues. 

Pyraclostrobin was rapidly and almost completely metabolized. Very little 

unchanged parent was detected. The phase one biotransformation is characterized 

by N-demethoxylation, various hydroxylations, cleavage of the ether bond and 

further oxidation of the two resulting molecule parts. Conjugation of the formed 

hydroxyl groups by glucuronic acid or sulfate also occurred. In summary, 

pyraclostrobin is extensively metabolized and rapidly eliminated primarily via the 

bile, with no evidence of accumulation in tissues.

7. Metabolite toxicology. A comparison of the rat metabolism results with the 

plant metabolism/residue results indicates that toxicology studies performed with 

the parent pyraclostrobin are sufficient to cover dietary exposure. Plant residues 

are primarily the parent compound with a fraction (up to 10-20% at most) being the 

demethoxylated parent. This metabolite is referred to as BF 500-3 in the plant 

studies and as 500M07 in the rat study. This metabolite in the rat is the first step in 

the major biotransformation process leading to the majority of the metabolites 

determined in the major excretion pathway.
5

8. Endocrine disruption. Endocrine effects. No specific tests have been 

conducted with pyraclostrobin to determine whether the chemical may have an 

effect in humans that is similar to an effect produced by a naturally occurring 

estrogen or other endocrine effects. However, there were no significant findings in 

other relevant toxicity studies (i.e., subchronic and chronic toxicity, teratology and 

multi-generation reproductive studies) which would suggest that pyraclostrobin 

produces endocrine related effects.

C. Aggregate Exposure 

1. Dietary exposure. Exposure assessments were conducted to evaluate the 

potential risk due to acute and chronic dietary exposure of the U.S. population and 

all sub-populations. The consumption data was from the NHANES 2-day food 

consumption data for 2003 to 2008 and the assessment was performed using the 

Dietary Exposure Evaluation Module (DEEM-FCID) software version 3.14. An 

assessment for water in the diet was performed in a separate analysis. The

assessments used 100 % crop treated and included all commodities with established 

tolerances and proposed tolerances submitted in May 2012 and the commodities 

proposed in this submission for tolerances as follows: artichoke, Belgium endive and 

persimmon. In addition tolerances for the following recently established groups or 

subgroups were used as follows: Berry and small fruit crop group 13-07, Fruit, 

citrus, crop group 10-10, Fruit, pome, crop group 11-10, Oilseed, crop group 20, 

Vegetable, bulb, crop group 3-07, Vegetable, fruiting crop group 8-10. The impact 

of the new commodities on the animal Maximum Reasonably Balanced Diets was 

minimal and thus no changes in tolerances in animal commodities are proposed.

i. Food. Acute Dietary Exposure Assessment

The inputs for previously registered commodities were based on tolerance values or 

highest average field trial (HAFT) residues as used in the acute dietary assessment 

conducted as part of the evaluation by EPA in February 11, 2008 (DP Number 

348308). A few input values were changed from the 2008 evaluation as follows: the 

HAFT of 10.7 mg/kg was used for the whole subgroup 4B (as was done in the EPA 

2005 analysis) rather than just for celery; the HAFT of 14.4 mg/kg was used for the 

radicchio (as was done in the EPA 2005 analysis) in addition to head lettuce; the 

HAFT of 21.2 mg/kg rather than 20.1was used for the leaf lettuce; the group 

tolerance of 2.5 was used for all stone fruit; the group tolerance of 0.45 was used for 

all oilseed except cotton seed. Process factors derived from experimental studies that 

differed from those used in the 2008 evaluation were used as follows: grape juice = 

0.14, tomato paste = 0.6, tomato puree = 0.3, tomato juice = 0.3. 

The resulting exposure estimates were compared against the pyraclostrobin (BAS 

500 F) acute Population Adjusted Dose (aPAD) of 3.00 mg/kg b.w./day for all 

populations except females age 13-49 years with an aPAD of 0.05 mg/kg b.w./day. 

The most highly exposed sub-population was females 13-49 years old with 84.3 % 
6

utilization of the aPAD. The results of the acute dietary assessment are presented in 

Table 1.

Table 1. Results for Pyraclostrobin (BAS 500 F) Acute Dietary Exposure (Food 

only) Considering all Current and Proposed Tolerances using DEEM-FCID at the 

95th Percentile

Population Exposure Estimate % aRfD

Subgroups (mg/kg b.w./day)

U.S. Population 0.042652 1.42

All Infants (< 1 year old) 0.055319 1.84

Children (1-2 years old) 0.079562 2.65

Children (3-5 years old) 0.070094 2.34

Children (6-12 years old) 0.041602 1.39

Youth (13-19 years old) 0.030026 1.00

Adults (20-49 years old) 0.039469 1.32

Adults (50+ years old) 0.039328 1.31

Females (13-49 years old) 0.042158 84.32

The results of the analysis show that for all populations, the estimated exposures are 

below the Agency's level of concern (< 100% aPAD). Additional refinements in the 

dietary risk assessment (i.e. utilizing additional anticipated residue values, percent 

crop treated values) would further reduce the estimated exposure values.

Chronic Dietary Exposure Assessment 

The inputs for previously registered commodities were based on tolerance values or 

average field trial residues as used in the chronic dietary assessment conducted as 

part of the evaluation by EPA in February 11, 2008 (DP Number 348308). A few 

input values were changed from the 2008 evaluation as follows: the HAFT of 0.21 

mg/kg was used for the subgroup 6C (except chickpea, guar and lentil at 0.34 

mg/kg) rather than the tolerance; the group tolerance of 2.5 was used for all stone 

fruit; the group tolerance of 0.45 was used for all oilseed except cotton seed. Process 

factors derived from experimental studies that differed from those used in the 2008 

evaluation were used as follows: grape juice = 0.14, tomato paste = 0.6, tomato puree 

= 0.3, tomato juice = 0.3. 

The resulting exposure estimates were compared against the pyraclostrobin chronic 

Population Adjusted Dose (cPAD) for the U.S. population and all sub-populations of 

0.034 mg/kg bw/day. This endpoint is based on the NOAEL value of 3.4 mg/kg 

bw/day using a FQPA safety factor of 1. The most highly exposed population subgroup was children 1-2 years of age which utilized 55.8% cPAD. The results of the 

chronic dietary assessment (food only) are presented in Table 2.

Table 2. Results for Pyraclostrobin (BAS 500 F) Chronic Dietary Exposure (Food 

only) Considering All Commodities using DEEM-FCID
7

Population Exposure Estimate % cPAD

Subgroups (mg/kg b.w./day)

U.S. Population 0.006239 18.4

All Infants (< 1 year old) 0.011203 33.0

Children (1-2 years old) 0.018972 55.8

Children (3-5 years old) 0.013556 39.9

Children (6-12 years old) 0.007481 22.0

Youth (13-19 years old) 0.003982 11.7

Adults (20-49 years old) 0.005205 15.3

Adults (50+ years old) 0.005617 16.5

Females (13-49 years old) 0.005012 14.7

The results of the risk assessment show that for all populations the exposures are 

below a level of concern (< 100% cPAD). Additional refinements in the dietary risk 

assessment (i.e. utilizing anticipated residue values, percent crop treated values) 

would further reduce the estimated exposure values.

ii. Drinking water. The water exposure values used for this analysis are from 

the most recent EPA assessment for pyraclostrobin (February 11, 2008, 

“Pyraclostrobin. Acute and Chronic Aggregate Dietary (Food and Drinking water) 

Exposure and Risk Assessment to Support new Uses on Oat Grain, Barley, Oilseed 

(Crop group 20), Fresh Herbs (Herbs Subgroup 10=9A), Avocado, Black Sapote, 

Canistel, Mamey Spoted, Mango, Papaya, Sapodilla, and Star Apple.” The highest 

water exposure values were from aerial application on ornamentals which resulted 

in an acute exposure of 35.6 ug/L and chronic exposure of 2.3 ug/L. These water 

exposure values are greater than the exposure from the current uses and the 

proposed new uses. 

Acute: The highest acute Estimated Drinking Water Concentration (EDWC) for 

pyraclostrobin (BAS 500 F) was estimated to be 35.6 μg/L (ppb) in surface water. 

The analysis was performed using DEEM-FCID software version 3.14 with the 

residue concentration in water set at 0.0356 mg/L based on the surface water 

concentration determined for the nursery use. The resulting exposure estimates 

were compared against the pyraclostrobin (BAS 500 F) acute Population Adjusted 

Dose (aPAD) of 3.00 mg/kg b.w./day for all populations except females age 13-49 

years with an aPAD of 0.05 mg/kg b.w./day. The most highly exposed subpopulation was females 13-49 years old with 3.9 % utilization of the aPAD. The 

results of the acute dietary assessment for water are presented in Table 3.

Table 3. Results for Pyraclostrobin (BAS 500 F) Acute Dietary Exposure (Water 

only) Considering all Current and Proposed Uses using DEEM-FCID at the 95th

Percentile

Population Exposure Estimate % aRfD

Subgroups (mg/kg b.w./day)
8

U.S. Population 0.001941 0.06

All Infants (< 1 year old) 0.00608 0.20

Children (1-2 years old) 0.002993 0.10

Children (3-5 years old) 0.002429 0.08

Children (6-12 years old) 0.001856 0.06

Youth (13-19 years old) 0.001617 0.05

Adults (20-49 years old) 0.00191 0.06

Adults (50+ years old) 0.001702 0.06

Females (13-49 years old) 0.001937 3.87

Chronic: The highest chronic Estimated Drinking Water Concentration (EDWC) 

for pyraclostrobin (BAS 500 F) was estimated to be 2.3 μg/L (ppb) in surface water. 

The analysis was performed using DEEM-FCID software version 3.14 with the 

residue concentration in water set at 0.0023 mg/L based on the surface water 

concentration determined for the nursery use. The resulting exposure estimates 

were compared against the pyraclostrobin chronic Population Adjusted Dose 

(cPAD) for the U.S. population and all sub-populations of 0.034 mg/kg bw/day. The 

most highly exposed population sub-group was infants less than 1 year of age which 

utilized 0.4% cPAD. The results of the chronic dietary assessment (water only) are 

presented in Table 4.

Table 4. Results for Pyraclostrobin (BAS 500 F) Chronic Dietary Exposure (Water 

only) Considering all Current and Proposed Uses using DEEM-FCID

Population Exposure Estimate % cPAD

Subgroups (mg/kg b.w./day)

U.S. Population 0.000048 0.1

All Infants (< 1 year old) 0.000124 0.4

Children (1-2 years old) 0.000069 0.2

Children (3-5 years old) 0.000059 0.2

Children (6-12 years old) 0.000042 0.1

Youth (13-19 years old) 0.000035 0.1

Adults (20-49 years old) 0.000048 0.1

Adults (50+ years old) 0.000048 0.1

Females (13-49 years old) 0.000048 0.1

Acute Aggregate Exposure and Risk (Food and water)

The aggregate acute risk includes residues of pyraclostrobin from food and water 

(Table 5). Exposures from residential uses are not included in the acute aggregate 

assessment. The results demonstrate that there are no safety concerns for any 

subpopulation based on established and new uses, and that the results clearly meet 

the FQPA standard of reasonable certainty of no harm.
9

Table 5. Estimated Acute Aggregate Exposure and Risk of Pyraclostrobin 

(Food and Drinking Water) 

Population Subgroup

Food 

Exposure 

(mg/kg/day)

Water 

Exposure 

(mg/kg/day)

Total 

Exposure 

(mg/kg/day)

% aPAD

U.S. Population 0.042652 0.001941 0.044593 1.5

All Infants (< 1 yr 

old)

0.055319 0.006080 0.085642 2.9

Children 1-2 years 0.079562 0.002993 0.073087 2.4

Children 3-5 years 0.070094 0.002429 0.044031 1.5

Children 6 – 12 years 0.041602 0.001856 0.031882 1.1

Youth 13-19 years 0.030026 0.001617 0.041086 1.4

Females 13-49 years 0.042158 0.001937 0.044095 88.2

Adults 20-49 years 0.039469 0.001910 0.041238 1.4

Adults + 50 0.039328 0.001702 0.043860 1.5

Short- and Intermediate Term Aggregate Exposure and Risk (food, water, and 

residential)

Short-term aggregate risk from pyraclostrobin takes into account exposures from 

dietary consumption (food and water) and residential exposure from turf use. Post 

application exposure from the turf use is considered short-term. The aggregate 

MOEs from food, water, and residential exposure are 105 and 229 for children 1-2 

years old and the US population, respectively. These MOEs are greater than the 

target MOE of 100 which indicates there is no safety concern. The results of the 

analysis are shown in Table 6. 

Table 6. Estimated Short/Intermediate Term Aggregate Exposure and Risk of 

Pyraclostrobin (Food, Drinking Water, and Residential exposure) 

Population

Target 

MOE1

Food 

Exposure 

(mg/kg/day)

Water 

Exposure 

(mg/kg/day)

Residential 

Exposure 

(mg/kg/day)

Total 

Exposure 

(mg/kg/day) MOE2

US 100 0.00624 0.000048 0.0190 0.0253 229

Child 1-2 yr 

old 100 0.01897 0.000069 0.0364 0.0554 105

1 Target MOE is 100.

2 Aggregate MOE = (NOAEL / (Food + Water + Residential Exposure), NOAEL = 

5.8 mg/kg b.w./day. 
10

Chronic Aggregate Exposure and Risk (food and water)

The aggregate chronic risk includes residues of pyraclostrobin from food and water 

(Table 7). Exposures from residential uses are not included in the chronic aggregate

assessment. The results demonstrate there are no safety concerns for any 

subpopulation based on established and new uses, and that the results clearly meet 

the FQPA standard of reasonable certainty of no harm. 

 Table 7. Estimated Chronic Aggregate Exposure and Risk of Pyraclostrobin 

(Food and Drinkiing water) 

Population Subgroup

Food 

Exposure 

(mg/kg/day)

Water 

Exposure 

(mg/kg/day)

Total 

Exposure 

(mg/kg/day)

% cPAD

U.S. Population 0.006239 0.000048 0.006287 18.5

All Infants (< 1 yr old) 0.011203 0.000124 0.011327 33.3

Children 1-2 years 0.018972 0.000069 0.019041 56.0

Children 3-5 years 0.013556 0.000059 0.019031 56.0

Children 6 – 12 years 0.007481 0.000042 0.007523 22.1

Youth 13-19 years 0.003982 0.000035 0.004017 11.8

Females 13-49 years 0.005012 0.000048 0.005060 14.9

Adults 20-49 years 0.005205 0.000048 0.005253 15.5

Adults + 50 0.005617 0.000048 0.005665 16.7

2. Non-dietary exposure. 

Pyraclostrobin is registered for use on residential and recreational turf. The 

applications to turf will be made only by professional pest control operators. 

Therefore, residential handler exposure was not evaluated. The exposure 

assessment cited in this notice of filing was transcribed from the Federal Register 

Notice on pyraclostrobin (U.S. EPA final rule published in the Federal Register 

October 29, 2004 [Vol 69, No. 209, p 63083 – 63100). The EPA evaluated the 

following post-application exposure scenarios 1) adults and toddler post-application 

dermal exposure 2) toddlers’ incidental ingestion of pesticide residues on lawns 

form hand-to-mouth transfer, 3) toddlers’ object-to-mouth transfer from mouthing 

pesticide-treated turfgrass, and 4) toddlers’ incidental ingestion of soil from 

pesticide-treated residential areas. A dermal absorption value of 14% was used in 

the assessment of pyraclostrobin. The exposure and risk estimates for the residential 

exposure scenarios are assessed for the day of application because adults and 

toddlers could contact treated turf immediately after application. All short-

/intermediate term MOEs were greater than 100 which indicates that exposure from 

all residential scenarios result in exposures below a level of concern.

D. Cumulative Effects Section 408(b)(2)(D)(v) requires that, when considering 

whether to establish, modify, or revoke a tolerance, the Agency consider ``available 

information'' concerning the cumulative effects of a particular pesticide's residues 

and ``other substances that have a common mechanism of toxicity.' Pyraclostrobin 
11

is a foliar fungicide which belongs to the class of strobilurin chemistry. It is a 

synthetic analog of strobilurin A, a naturally occurring antifungal metabolite of the 

mushroom Strobillurus tenacellus (Anke et. al., 1977). The active ingredient acts in 

the fungal cell through inhibition of electron transport in the mitochondrial 

respiratory chain at the position of the cytochrome-bc1 complex. The protective 

effect is due to the resultant death of the fungal cells by disorganization of the fungal 

membrane system. Pyraclostrobin also acts curatively to prevent the increase and 

spread of fungal infections by inhibiting mycelial growth and sporulation on the leaf 

surface. Pyraclostrobin inhibits spore germination, germ tube growth and 

penetration into the host tissues

The EPA is currently developing methodology to perform cumulative risk 

assessments. At this time, there is no available data to determine whether 

pyraclostrobin has a common mechanism of toxicity with other substances or how to 

include this pesticide in a cumulative risk assessment. Unlike other pesticides for 

which EPA has followed a cumulative risk approach based on a common 

mechanism of toxicity, pyraclostrobin does not appear to produce a toxic metabolite 

common to other substances.

E. Safety Determination

1. U.S. population. Based on this risk assessment, BASF concludes that there 

is a reasonable certainty that no harm will result to the general population from the 

aggregate exposure to pyraclostrobin from the existing and proposed new uses.

2. Infants and children. Based on this risk assessment, BASF concludes that 

there is a reasonable certainty that no harm will result to infants or children from 

the aggregate exposure to pyraclostrobin from the existing and proposed new uses.

F. International Tolerances

No Codex maximum residue levels (MRLs) have been established for 

residues of pyraclostrobin. Therefore, no tolerance discrepancies exist between 

countries for this chemical.