EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

Interregional Research Project No. 4 (IR-4)

Petition #3E8216

EPA has received a pesticide petition (3E8216) from IR-4, Rutgers, The State 

University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540

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

(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for 

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

yl]oxy]methyl]phenyl]methoxy-, methyl ester and its desmethoxy metabolite (methyl-N-

[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl] phenylcarbamate) (BF 500-3); 

expressed as parent compound in or on the raw agricultural commodity for Herb 

subgroup 19A at 85 parts per million (ppm), dill, seed at 100 ppm and updating existing 

crop groups to Fruit, stone, group 12-12 at 2.5 ppm and Nut, tree, group 14-12 at 0.04 

ppm except pistachio. Additionally, it was proposed that upon establishment of the stone 

fruit group 12-12 and tree nut group 14-12 tolerances, that the existing tolerances for 

fruit, stone, group 12; and nut, tree, group 14 be removed as unnecessary. 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 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]otolyl] 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 residue of pyraclostrobin (BAS 500F) in fresh chives, fresh and dry 

basil, fresh dill, and dill, seed to satisfy the requirements for a tolerance of pyraclostrobin

in Herbs, subgroup 19A and dill, seed. The number and locations of field trials are in 
2

accordance with OPPTS Guideline 860.1500. Field trials were carried out using the 

maximum use rate, the maximum number of applications, and the minimum pre-harvest 

interval. Field trials in the representative commodities for the following crop groups were 

previously submitted and accepted and crop group tolerances were established for Stone 

fruits group and Tree nuts group. This action proposes updating these crop groups to the 

current Fruit, stone, group 12-12 and Nut, tree, group 14-12 except pistachio. No new 

residue data was generated or needed in support of these crop group updates. 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. An acute 

neurotoxicity study in rats was conducted up to 1000 mg/kg bw/day with no evidence of 

neurotoxity.

2. Genotoxicity. 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 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 
3

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.

Three 28-day studies have been performed to evaluate the ability of pyraclostrobin to 

affect the immune system. There were no changes observed on functional immune 

parameters that are considered to be adverse.

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 28-day inhalation study, the highest concentrations of pyraclostrobin caused effects 

on the nasal cavity. The NOAEC was 1 mg/m3

.

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 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 
4

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.

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 
5

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 the commodities proposed in 

this submission for tolerances as follows: herb, subgroup 19A, dill, seed. In addition 

tolerances for the following recently established groups or subgroups were used as 

follows: fruit, stone, group 12-12 and nut, tree, group 14-12 except pistachio. 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) 

and tolerance values established since that date. 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 0.45 was used for all oilseed including 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 HAFT values were used for basil fresh (16.1 ppm), basil dry 

(80.6 ppm), and dill weed (19.0), and the proposed tolerance of 85 ppm was used for all 

other fresh and dry herbs in subgroup 19A, and dill, seed. 

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 85.1 % 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 0.043221 1.44

All Infants (< 1 year old) 0.056011 1.87

Children (1-2 years old) 0.080437 2.68

Children (3-5 years old) 0.073036 2.43

Children (6-12 years old) 0.042344 1.41

Youth (13-19 years old) 0.030471 1.02

Adults (20-49 years old) 0.039798 1.33

Adults (50+ years old) 0.039633 1.32
6

Females (13-49 years old) 0.042543 85.09

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, highest 

average field trail or average field trial residues as used in the chronic dietary assessment 

conducted as part of the evaluations by EPA in February 11, 2008 (DP Number 348308) 

and in April 17, 2013 (DP Number 410739). A few input values were changed from the 

2008 evaluation as follows: the HAFT of 0.21 ppm was used for the subgroup 6C (except 

chickpea, guar and lentil at 0.34 ppm) rather than the tolerance;. Process factors derived 

from experimental studies that differed from those used in the 2008 evaluation were used 

as follows:, tomato juice = 0.3. Values of percent crop treated from the EPA evaluation of 

April 17, 2013 (DP Number 410739) were used. The highest average field trial (HAFT) 

residue of 16.1 ppm and 80.6 ppm measured in the residue trials was used for fresh and 

dry basil, respectively, and the HAFT for dry basil was used for the remaining 

commodities in herb subgroup 19A. The highest average field trial (HAFT) residue of 

51.8 ppm was used for dill seed.

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 sub-group was 

children 1-2 years of age which utilized 30.1% 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

Population Exposure Estimate % cPAD

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

U.S. Population 0.002905 8.5

All Infants (< 1 year old) 0.004328 12.7

Children (1-2 years old) 0.010231 30.1

Children (3-5 years old) 0.007050 20.7

Children (6-12 years old) 0.003946 11.6

Youth (13-19 years old) 0.002061 6.1

Adults (20-49 years old) 0.002387 7.0

Adults (50+ years old) 0.002262 6.7

Females (13-49 years old) 0.002170 6.4
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 19A), 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 sub-population 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)

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 
8

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 subgroup 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.

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
9

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 109 and 228 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. 

The Dermal exposure is from use on residential turf. The oral exposure is from food, 

drinking water and oral exposure from residential turf use (hand to mouth) for children 1 

-2 years of age. 

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

Pyraclostrobin (Food, Drinking Water, and Residential exposure) 

Population

Target 

MOE1

Oral 

Exposure 

(mg/kg/day) Oral MOE

Dermal 

Exposure 

(mg/kg/day)

Dermal 

MOE

Aggregate 

MOE2

US 100 0.002953 1693 0.019 263 228

Child 1-2 yr 

old 100 0.01510 384 0.033 152 109

1 Target MOE is 100.

2 Aggregate MOE = 1 /[(1/MOE dermal) + (1/MOE oral)], Oral NOAEL = 5.8 mg/kg 

b.w./day, Dermal NOAEL = 5.0 mg/kg b.w./day. 

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 Drinking 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
10

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 turf, gardens, and professional turf. 

and recreational turf. The use on residential turf results in the highest exposure to 

children 1-2 and adults. The exposure assessment cited in this notice of filing is from the 

EPA most recent evaluation using the new residential SOPs (May 8, 2013 ) . 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 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. 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.
11

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 in fresh herbs or dill seed. Therefore, no tolerance discrepancies exist 

between countries for this chemical.