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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

CHEMICAL SAFETY AND

POLLUTION PREVENTION

MEMORANDUM

Date: July 3, 2013

SUBJECT: Pyraclostrobin – Human Health Risk Assessment for a Section 3 Registration of 

New Uses on Sugarcane, Globe Artichoke, Belgium Endive, Persimmon, 

Greenhouse Grown Tomato Transplants for Home Consumer Market, and 

Residential Ornamentals, Landscape Gardens, Fruit Trees, and Nut Trees; Plus 

Crop Group Expansions/Revisions for Bulb Vegetable Group 3-07, Fruiting 

Vegetable Group 8-10, Citrus Fruit Group 10-10, Pome Fruit Group 11-10, Berry

Subgroups 13-07A, B, F, and G, and Oilseed Group 20.

PC Code: 099100 DP Barcode: D403462, D398877, D405065, D406472, D406652

Decision Nos.: 465126, 468304, 459294, 470110, 

467106

Registration Nos.: 7969-185, 7969-186, 7969-247, 7969-258, 

7969-289, 7969-291, 7969-199, 7969-251, 7969-GLG, 4-UII

Petition No.: 2F8038, 2F8069 Regulatory Action: Section 3 Registration

Risk Assessment Type: Single Chemical/Aggregate Case No.: NA

TXR No.: NA CAS No.: 175013-18-0

MRID No.: NA 40 CFR: 180.582

FROM: Barry O’Keefe, Senior Biologist

Vincent Chen, Toxicologist

Steve Funk, Senior Chemist

Cassi Walls, Senior Biologist

Risk Assessment Branch III (RAB III)

Health Effects Division (7509P)

THROUGH: Christine Olinger, Branch Chief

Risk Assessment Branch III (RAB III) 

Health Effects Division (7509P)

TO: Heather Garvie, Risk Manager

Dominic Schuler, Risk Manager

Robert Westin, Risk Manager

Fungicide Branch

Registration Division (7505P)

and

Andrew Ertman, Risk Manager

Risk Integration, Minor Use and Emergency Response Branch

Registration Division (7505P)
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This document and attachments provide an assessment of the human health risk resulting from 

the proposed and registered uses of pyraclostrobin. The toxicology reevaluation was performed 

by Vincent Chen, the drinking water assessment was conducted by Faruque Khan (EPA 

Environmental Fate and Effects Division (EFED)), the review of the residue chemistry data and

the dietary exposure assessment were conducted by Steve Funk, the occupational and residential 

exposure assessment was conducted by Cassi Walls, and human health risk assessment was

conducted by Barry O’Keefe. 
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1.0 Executive Summary........................................................................................................... 5

2.0 HED Recommendations.................................................................................................... 7

2.1 Data Deficiencies ............................................................................................................ 8

2.2.1 Enforcement Analytical Method ............................................................................... 8

2.2.2 Recommended Tolerances......................................................................................... 8

2.2.3 Revisions to Petitioned-For Tolerances.................................................................. 11

2.2.4 International Harmonization................................................................................... 12

3.0 Introduction...................................................................................................................... 13

3.1 Chemical Identity ......................................................................................................... 14

3.2 Physical/Chemical Characteristics ............................................................................. 14

3.3 Pesticide Use Pattern.................................................................................................... 14

3.4 Anticipated Exposure Pathways................................................................................. 17

3.5 Consideration of Environmental Justice.................................................................... 18

4.0 Hazard Characterization and Dose-Response Assessment.......................................... 18

4.1 Toxicology Studies Available for Analysis................................................................. 18

4.2 Absorption, Distribution, Metabolism and Excretion (ADME) .............................. 19

4.2.1 Dermal Absorption................................................................................................... 19

4.3 Summary of Toxicological Effects.............................................................................. 19

4.4 Safety Factor for Infants and Children (FQPA Safety Factor) ............................... 20

4.4.1 Completeness of the Toxicology Database.............................................................. 20

4.4.2 Evidence of Neurotoxicity........................................................................................ 20

4.4.3 Evidence of Sensitivity/Susceptibility in the Developing or Young Animal........ 20

4.4.4 Residual Uncertainty in the Exposure Database ................................................... 21

4.5.1 Dose-Response Assessment...................................................................................... 21

4.5.2 Recommendation for Combining Routes of Exposure for Risk Assessment ...... 22

4.5.3 Cancer Classification and Risk Assessment Recommendation............................ 23

4.5.4 Summary of Points of Departure and Toxicity Endpoints Used in Human Risk 

Assessment............................................................................................................................... 23

5.0 Dietary Exposure and Risk Assessment......................................................................... 25

5.1 Residues of Concern Summary and Rationale.......................................................... 25

5.2 Food Residue Profile .................................................................................................... 25

5.3 Water Residue Profile.................................................................................................. 27

5.4 Dietary Risk Assessment.............................................................................................. 28

5.4.1 Description of Residue Data Used in Dietary Assessment.................................... 28

5.4.2 Percent Crop Treated Used in Dietary Assessment .............................................. 29

5.4.3 Acute Dietary Risk Assessment............................................................................... 29

5.4.4 Chronic Dietary Risk Assessments ......................................................................... 30

5.4.5 Summary Table......................................................................................................... 30

6.0 Residential (Non-Occupational) Exposure/Risk Characterization ............................. 30

6.1 Residential Handler Exposure .................................................................................... 31

6.2 Post-Application Exposure.......................................................................................... 33

6.3 Combined Residential Risk Estimates (Multiple Exposure Scenarios)................... 35

6.4 Residential Risk Estimates for Use in Aggregate Assessment.................................. 35

6.5 Residential Bystander Post-application Inhalation Exposure ................................. 36

6.6 Spray Drift.................................................................................................................... 36
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7.0 Aggregate Exposure/Risk Characterization.................................................................. 37

7.1 Acute Aggregate Risk................................................................................................... 37

7.2 Short-Term Aggregate Risk........................................................................................ 37

7.3 Intermediate-Term Aggregate Risk ........................................................................... 38

7.4 Chronic Aggregate Risk .............................................................................................. 38

8.0 Cumulative Exposure/Risk Characterization ............................................................... 38

9.0 Occupational Exposure/Risk Characterization ............................................................ 39

9.1 Short-/Intermediate-Term Handler Risk................................................................... 39

9.2 Short-and Intermediate-Term Post-Application Risk.............................................. 40

9.2.1 Dermal Post-Application Risk................................................................................. 40

9.2.2 Inhalation Post-Application Risk............................................................................ 41

10.0 References......................................................................................................................... 42

Appendix A. Toxicology Profile and Executive Summaries .................................................. 43

A.1 Toxicology Data Requirements................................................................................... 43

A.2 Toxicity Profiles............................................................................................................ 43

Appendix B. Physicochemical Properties of Pyraclostrobin.................................................. 50

Appendix C. Review of Human Research................................................................................ 50

Appendix D. Summaries of Field Residue Data...................................................................... 51

Appendix E. Summaries of Occupational Handler and Post-application Exposure and Risk 

Estimates...................................................................................................................................... 53

Appendix F. Summary of Pyraclostrobin DFR Study Results.............................................. 57

Appendix G. International Residue Limits Status Sheet ....................................................... 58
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1.0 Executive Summary

Introduction

Pyraclostrobin [carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl] 

phenyl]methoxy-, methyl ester] belongs to the strobilurin class of fungicides (β-methoxyacrylate 

class of compounds). Strobilurins are synthetic analogs of a natural antifungal substance which 

inhibit spore germination, mycelial growth, and sporulation of the fungus on the leaf surface. 

Pyraclostrobin is currently registered on numerous agricultural crops and on residential and golf 

course turf.

Use Profile

The proposed actions of pyraclostrobin are as follows: 1) BASF Corporation (BASF) is 

proposing a new agricultural use (PP# 2F8038) on sugarcane; 2) The Interregional Research 

Project No. 4 (IR-4) is proposing new agricultural uses (PP# 2F8069) on artichoke, Belgium

endive, and persimmon; 3) BASF is proposing a new greenhouse tomato use for commercial 

production and for tomato transplants grown for the home consumer market; 4) Bonide Products 

is proposing a new use on residential fruit and nut trees; and 5) BASF is proposing new uses on 

residential ornamentals and landscape gardens. Additionally, crop group expansions/revisions 

were requested for the bulb vegetable group 3-07, fruiting vegetable 8-10, citrus fruit group 10-

10, pome fruit group 11-10, berry subgroups 13-07A, B, F, and G, and oilseed group 20.

The proposed agricultural labels require occupational handlers to wear the following personal 

protective equipment (PPE): long-sleeved shirts, long pants, chemical resistant gloves, and 

coveralls in a few cases. The 12 hour restricted entry interval (REI) listed on the labels is 

appropriate. 

Exposure Profile

The proposed residential uses result in short-term handler dermal and inhalation exposures for 

adults, short-term post-application dermal exposures for adults, youths (11 to 16 years old), and 

children 6 to 11 years old, and short-term post-application dermal and incidental oral exposures 

for children (1 to <2 years old). Exposure pathways include dietary (food and drinking water), 

and residential exposure sources. Dietary exposures are also expected for acute and chronic 

durations. Occupational exposures are expected via dermal and inhalation routes for short- and 

intermediate-term durations.

Hazard Assessment 

Pyraclostrobin has moderate to low acute toxicity via the oral, dermal, and inhalation routes of 

exposure. Pyraclostrobin is not a dermal sensitizer, but was determined to produce a low acute

dermal effect and eye irritation. The primary target tissues appear to be mucosal membranes, 

with pathology or secondary effects (e.g. diarrhea) observed in different species. The primary

effects were decreased body weight, body weight gain, and food consumption, and diarrhea. 

Pyraclostrobin was classified as “Not likely to be Carcinogenic to Humans.” There are no 

concerns for reproductive susceptibility, neurotoxicity, mutagenicity, genotoxicity, or 

immunotoxicity. Based on the available data, toxicity endpoints and points of departure (PODs) 

have been selected for acute and chronic dietary, short-term incidental oral, and short- and 

intermediate-term dermal and inhalation exposure scenarios. Dermal absorption is 14%. 
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Inhalation toxicity is assumed to be equivalent to oral toxicity for non-cancer risk assessments. 

The Food Quality Protection Act (FQPA) Safety Factor has been reduced to 1X because the 

toxicity database is complete, there is no concern for susceptibility in infants and young children, 

there are no neurotoxicity concerns, and there are no residual uncertainties regarding exposure.

Dietary Exposure

The residue chemistry data and environmental fate data are adequate to assess human dietary

exposure. The assessments are based on reliable data and will not underestimate exposure or 

risk. Estimated drinking water concentrations (EDWCs) were incorporated directly into the 

dietary exposure assessments; i.e., for acute dietary 35.6 μg/L from surface water (from turf use) 

and for chronic dietary 2.3 μg/L from surface water (from turf use).

The results of the acute dietary (food and drinking water) analysis using tolerance level residues 

or highest field trial residues indicate that acute dietary risks do not exceed the Agency’s level of 

concern (LOC <100% of the acute Population Adjusted Dose (aPAD)) for the U.S. population 

and all subgroups. Combined dietary exposure from food and drinking water at the 95th

percentile of exposure for the U.S. population is equivalent to 1.5% of the aPAD. The 

population subgroup with the highest estimated acute dietary exposure to pyraclostrobin is 

females 13-49 years, with an estimated exposure at the 95th percentile of 87% of the aPAD.

The results of the refined chronic dietary (food and drinking water) analysis using tolerance level 

residues or highest field trial residues and percent crop treated values are below the Agency’s 

LOC for all population subgroups. The dietary exposure for food and drinking water for the 

general U.S. population is 8.0% of the chronic Population Adjusted Dose (cPAD) and 27% of the 

cPAD for children 1-2 years old, the population subgroup with the highest estimated chronic 

dietary exposure to pyraclostrobin.

Residential Exposure

New residential uses were requested in this action. However, pyraclostrobin is currently 

registered for use on residential and golf course turf. Existing residential exposures and risks 

from use on turf were reassessed using the updated 2012 HED Residential Standard Operating 

Procedures1(SOPs). All residential handler dermal and inhalation exposure risk estimates were 

not of concern to HED, with margins of exposure (MOEs) ranging from 590 to 3,900,000. All 

residential post-application exposure risk estimates were also not of concern to HED, with MOEs 

ranging from 150 to 340,000. 

Aggregate Exposure

The adult aggregate MOE is 230, which includes post-application exposure to treated turf and 

background dietary exposure and is not of concern to HED. The aggregate MOE for children 1-

2 years old, including incidental oral exposures from treated turf, is 120, which is not of concern 

to HED.

Occupational Exposure

Based on the proposed use pattern of pyraclostrobin, there is potential for short- and 

intermediate-term occupational exposure during mixing, loading, and other handling tasks; and 

 

1

http://www.epa.gov/pesticides/science/residential-exposure-sop.html
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during post-application activities. The proposed labels require occupational handlers to wear the 

following personal protective equipment (PPE): long-sleeved shirts, long pants, and chemical 

resistant gloves. All of the dermal MOEs are not of concern with labeled PPE (gloves).

The handler inhalation MOEs range from 33 to 8,500 at baseline PPE (no respirator). The two 

inhalation scenarios with MOEs below 100 at baseline PPE [mixing/loading of WDG 

formulation to support aerial and chemigation applications to artichoke and persimmon 

(MOE=33); and mixing/loading/applying (M/L/A) of WDG formulation using a mechanically

pressurized handgun to treat greenhouse tomatoes (MOE=85)] were no longer a concern to HED 

when assessed with a PF5 respirator (MOEs >100). A PF5 respirator needs to be proposed on 

the affected Pristine Fungicide [EPA Reg. No.7969-199] and Pagent® Fungicide [EPA Reg. 

No.7969-251] labels.

The short- and intermediate-term post-application dermal exposure risk estimates for workers for 

all scenarios were not of concern on day 0 (12 hours after application), with MOEs ranging from 

120 to 12,000.

Based on the Agency's current practices, a quantitative occupational post-application inhalation 

exposure assessment was not performed for pyraclostrobin at this time. If new policies or 

procedures are put into place, the Agency may revisit the need for a quantitative occupational 

post-application inhalation exposure assessment for pyraclostrobin. The 12 hour restricted entry

interval (REI) listed on the labels is appropriate. 

Review of Human Research

This risk assessment relies in part on data from studies in which adult human subjects were 

intentionally exposed to a pesticide or other chemical. These data, which include studies from 

the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1), the Agricultural Handler 

Exposure Task Force (AHETF) database, the Residential SOPs (lawns and turf), and MRID 

45773201 are subject to ethics review pursuant to 40 CFR 26, have received that review, and are 

compliant with applicable ethics requirements. For certain studies that review may have 

included review by the Human Studies Review Board. Descriptions of data sources as well as 

guidance on their use can be found at http://www.epa.gov/pesticides/science/handler-exposuredata.html and http://www.epa.gov/pesticides/science/post-app-exposure-data.html. 

Environmental Justice Considerations

Potential areas of environmental justice concerns, to the extent possible, were considered in this 

human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions 

to Address Environmental Justice in Minority Populations and Low-Income Populations," 

(http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf. 

2.0 HED Recommendations

HED has examined the toxicology and residue chemistry databases for pyraclostrobin. Pending 

submission of revised Sections B and F, there are no toxicology or residue chemistry issues that 

would preclude granting Section 3 registration for the requested uses of pyraclostrobin, or 

establishment of tolerances for residues of pyraclostrobin. Additional data are needed, as 
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outlined below in Section 2.1. The specific tolerance recommendations are discussed in Section 

2.2, and label modifications are discussed in Section 2.3.

2.1 Data Deficiencies

None

2.2 Tolerance Considerations

2.2.1 Enforcement Analytical Method

There are adequate residue analytical methods for tolerance enforcement. Two adequate 

methods are available for enforcement purposes for residues of pyraclostrobin and the metabolite 

BF 500-3 in/on plant commodities: an LC/MS/MS method (BASF Method D9908) and an 

HPLC/UV method (Method D9904). The validated method LOQ for both pyraclostrobin and BF 

500-3 is 0.02 ppm in all tested plant matrices, for a combined LOQ of 0.04 ppm. Adequate 

independent method validation and radiovalidation data were submitted for both methods.

Pyraclostrobin was successfully evaluated through several of the FDA protocols, while recovery

of BF 500-3 was unsuccessful in all protocols. The results of the multiresidue testing for 

pyraclostrobin were forwarded to FDA on 1/4/02 for the purpose of updating the Pesticide 

Analytical Manual, Volume I (PAM I).

2.2.2 Recommended Tolerances

HED has examined the residue chemistry database for pyraclostrobin and evaluated the adequacy

of submissions associated with the current actions. For the proposed use on sugarcane, a 

tolerance is required. A time-limited Section 18 tolerance of 0.02 ppm exists (40 CFR 

§180.582(b). Based on evaluation of the sugarcane field trial data with the Organization for 

Economic Cooperation and Development (OECD) tolerance calculation procedure, a permanent 

tolerance of 0.2 ppm is appropriate for sugarcane, cane. Pyraclostrobin residues did not 

concentrate in sugarcane molasses and sugarcane refined sugar. Therefore, these commodities 

are covered by the tolerance for the raw agricultural commodity, sugarcane, cane.

The proposed updating of certain existing crop groups and the removal of certain oilseed 

tolerances and certain previous crop group/subgroup tolerances are acceptable. However, an 

additional oilseed tolerance will need to be removed, and IR-4 should request the following 

removal: cotton, undelinted seed (0.3 ppm). 

The Section 18 tolerance for Belgium endive should be removed concurrent with the 

establishment of the Section 3 tolerance for Belgium endive.

The recommended tolerances for pyraclostrobin commodities or commodity groups are 

presented in Table 2.2.2.1. Compliance with the tolerance levels is to be determined by 

measuring only the sum of pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H- pyrazol3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl N-[[[1-
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(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl carbamate), calculated as the 

stoichiometric equivalent of pyraclostrobin. 

Table 2.2.2.1. Tolerance Summary for Pyraclostrobin.

Commodity Proposed/Existing 

Tolerance (ppm)

Recommended/ 

Harmonized 

Tolerance (ppm)

Comments; Correct Commodity 

Definition

40CFR§180.582(a)

Artichoke, globe 3.0 3.0

Endive, belgium 3.0 4.0 OECD statistical calculation 

estimates 4.0 ppm.

Persimmon 3.0 3.0

Sugarcane, cane 0.2 0.20

Vegetable, bulb, group 3-07 0.9 0.9 Crop group update

Vegetable, bulb, group 3 0.9 Remove Crop group update

Vegetable, fruiting, group 8-10 1.4 1.4 Crop group update

Vegetable, fruiting, group 8 1.4 Remove Crop group update

Fruit, citrus, group 10-10 2.0 2.0 Crop group update

Fruit, citrus, group 10 2.0 Remove Crop group update

Fruit, pome, group 11-10 1.5 1.5 Crop group update

Fruit, pome, group 11 1.5 Remove Crop group update

Oilseed group 20 0.45 0.45 Crop group creation.

Cotton, undelinted seed 0.3 Remove

To be replaced by oilseed group 

20. IR-4 needs to request this 

removal.

Borage, seed 0.45 Remove To be replaced by oilseed group 

20. 

Castor oil plant, seed 0.45 Remove To be replaced by oilseed group 

20. 

Chinese tallowtree, seed 0.45 Remove To be replaced by oilseed group 

20. 

Crambe, seed 0.45 Remove To be replaced by oilseed group 

20. 

Cuphea, seed 0.45 Remove To be replaced by oilseed group 

20. 

Echium, seed 0.45 Remove To be replaced by oilseed group 

20. 

Euphorbia, seed 0.45 Remove To be replaced by oilseed group 

20. 

Evening primrose, seed 0.45 Remove To be replaced by oilseed group 

20. 

Flax, seed 0.45 Remove To be replaced by oilseed group 

20. 

Gold of pleasure, seed 0.45 Remove To be replaced by oilseed group 

20. 

Hare's ear mustard, seed 0.45 Remove To be replaced by oilseed group 

20. 
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Table 2.2.2.1. Tolerance Summary for Pyraclostrobin.

Commodity Proposed/Existing 

Tolerance (ppm)

Recommended/ 

Harmonized 

Tolerance (ppm)

Comments; Correct Commodity 

Definition

Jojoba, seed 0.45 Remove To be replaced by oilseed group 

20. 

Lesquerella, seed 0.45 Remove To be replaced by oilseed group 

20. 

Lunaria, seed 0.45 Remove To be replaced by oilseed group 

20. 

Meadowfoam, seed 0.45 Remove To be replaced by oilseed group 

20. 

Milkweed, seed 0.45 Remove To be replaced by oilseed group 

20. 

Mustard, seed 0.45 Remove To be replaced by oilseed group 

20. 

Niger seed, seed 0.45 Remove To be replaced by oilseed group 

20. 

Oil radish, seed 0.45 Remove To be replaced by oilseed group 

20. 

Poppy, seed 0.45 Remove To be replaced by oilseed group 

20. 

Rapeseed, seed 0.45 Remove To be replaced by oilseed group 

20. 

Rose hip, seed 0.45 Remove To be replaced by oilseed group 

20. 

Safflower, seed 0.45 Remove To be replaced by oilseed group 

20. 

Stokes aster, seed 0.45 Remove To be replaced by oilseed group 

20. 

Sunflower, seed 0.45 Remove To be replaced by oilseed group 

20. 

Sweet rocket, seed 0.45 Remove To be replaced by oilseed group 

20. 

Tallowwood, seed 0.45 Remove To be replaced by oilseed group 

20. 

Tea oil plant, seed 0.45 Remove To be replaced by oilseed group 

20. 

Vernonia, seed 0.45 Remove To be replaced by oilseed group 

20. 

Caneberry subgroup 13-07A 4.0 4.0 Group update

Bushberry subgroup 13-07B 4.0 4.0 Group update

Small fruit, vine climbing 

subgroup (except fuzzy kiwi) 

13-07F

2.0 2.0

Fruit, small vine climbing, 

except fuzzy kiwifruit, subgroup 

13-07F

Group update

Low growing berry subgroup 

13-07G except cranberry 1.2 1.2

Berry, low growing, subgroup 

13-07G, except cranberry

Group update
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Table 2.2.2.1. Tolerance Summary for Pyraclostrobin.

Commodity Proposed/Existing 

Tolerance (ppm)

Recommended/ 

Harmonized 

Tolerance (ppm)

Comments; Correct Commodity 

Definition

Berry, group 13 4.0 Remove Group update. Replaced with 

subgroups 13-07A and 13-07B

Grape 2.0 Remove Group update. Replaced with 

subgroup 13-07F

Strawberry 1.2 Remove Group update. Replaced with 

subgroup 13-07G

40CFR§180.582(b) Section 18 emergency exemptions

Endive, belgium 11.0 Remove Replaced with Section 3 

tolerance for endive, belgium

Sugarcane, cane 0.02 Revoke Replaced with new tolerance in 

(a)

Sugarcane, molasses 0.40 Revoke Replaced with new tolerance in 

(a) for sugarcane, cane

No new tolerances are proposed for pyraclostrobin based on the proposed greenhouse use on 

fruiting vegetables. The existing tolerance for fruiting vegetables will cover the requested new 

uses of the PageantTM fungicide (EPA Reg. No. 7969-251) formulation.

No new tolerances are proposed for pyraclostrobin based on the proposed residential use on

pome fruit, stone fruit, and tree nuts using the proposed label for the Bonide Products, Inc FT09 

(EPA File Symbol 4-UII). The existing tolerances based on the BASF Pristine®label cover these

residential uses on pome fruit, stone fruit, and tree nuts. The Bonide Products, Inc FT09 label 

compares favorably with the BASF Pristine®label. Therefore, the existing tolerances for pome 

fruit, stone fruit, and tree nuts will also cover the proposed new residential uses.

2.2.3 Revisions to Petitioned-For Tolerances

The available data for Belgium endive will not support a tolerance level of 3.0 ppm. A revised 

Section F should be submitted with a tolerance for endive, Belgium at 4.0 ppm. 

Several crop group conversions were requested. Most were crop group updates. One request was 

to replace individual oilseed tolerances with an oilseed crop group 20 tolerance. This was 

accompanied by a request to remove numerous individual commodity oilseed tolerances. These 

changes have been made to the proposed labels. In addition to the requested removals, the 

existing tolerance for cotton undelinted seed will be replaced by oilseed group 20, and IR-4 

needs to make this request. The tolerance covering undelinted cotton seed is raised from 0.3 

ppm to 0.45 ppm. This is acceptable as cottonseed is one of the three representative 

commodities for the oilseed group (cottonseed, rapeseed, sunflower), and the highest estimate 

from the three commodities is adopted for the group. The changes are acceptable, as detailed in 

Table 2.2.2.1.
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860.1550 Proposed Tolerances

 The available data for Belgium endive will not support a tolerance level of 3.0 ppm. A 

revised Section F should be submitted with a tolerance for endive, Belgium at 4.0 ppm.

 The existing tolerance for undelinted cottonseed seed should be removed as it is replaced 

by the proposed and recommended tolerance for oilseed group 20. A revised Section F 

should be submitted.

2.2.4 International Harmonization

Codex and Canada have not established maximum residue limits (MRLs) for pyraclostrobin on 

sugarcane, Belgium endive and persimmon. Therefore, there is no issue of harmonization at this 

time (see Appendix G). 

A Codex MRL has been established for pyraclostrobin in/on globe artichoke at 2.0 ppm. The 

recommended US tolerance is 3.0 ppm. Residue definitions are different in the US and in 

Codex, and the US tolerance is based on application of the OECD tolerance calculation 

procedure to the validated field trial data. The tolerance cannot be lowered to the Codex level as 

this could result in apparent violations for crops treated in accordance with the label. Canada 

does not have pyraclostrobin tolerances for globe artichoke, Belgium endive, or persimmon. 

Therefore, there is no issue of harmonization with Canada at this time (see Appendix G).

The crop group/subgroup conversions were considered for possible harmonization with Codex. 

The Codex has established an MRL for one or more commodities in the bulb vegetable group 3-

07, in the fruiting vegetables group 8-10, in the pome fruit group 11-10, in the caneberry 

subgroup 13-07A, in the bushberry subgroup 13-07B, in the small fruit vine climbing subgroup 

13-07F, and in the low growing berry subgroup 13-07G. The Codex has established an MRL for 

the Codex equivalent of the US citrus fruit group 10-10 and for the oilseed group 20. 

Harmonization with these groups or subgroups is not possible because the residue definitions 

used by the US and Codex are different. Therefore, the resulting numerical values refer to 

different residues.

The US and Canadian residue definitions are harmonized. For the crop group conversions, the 

US is harmonized with Canada for bulb vegetables group 3-07, citrus fruit group 10-10, pome 

fruit group 11-10, oilseed group 20, caneberry subgroup 13-07A, bushberry subgroup 13-07B, 

small fruit, vine climbing subgroup 13-07F, and low growing berry subgroup 13-07G. The US is 

not harmonized with Canada for fruiting vegetables group 8-10, where the US group tolerances 

is 1.4 ppm and Canada has 1.0 ppm for tomato and pepper. The US is not harmonized with 

Canada for caneberry subgroup 13.07A and for bushberry subgroup 13-07B. The US tolerances 

for caneberry subgroup 13.07A and for bushberry subgroup 13-07B are 4.0 and 4.0 ppm, 

respectively, whereas the Canadian tolerances are 3.5 and 3.5 ppm, respectively. 
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2.3 Label Recommendations

860.1200 Directions for Use

 A revised label is required for EPA Reg. No. 7969-247 (12.0% EC, Multiva®). The 

proposed label has a maximum seasonal rate of 0.52 lb ai/acre for sugarcane. However, 

the directions state that no more than 80 ounces of MultivaTM should be applied per 

season, which is equivalent to 0.68 lb ai. The 80 ounces is incorrect and must be changed 

to 62 ounces of product.

 The proposed labels for EPA Reg. No. 7969-199 (Pristine® Fungicide), and EPA Reg. 

No. 7969-187(Cabrio® EG Fungicide) provide directions for use on the low growing 

berry subgroup. Cranberry must be removed from the list of crops. The title “low 

growing berry subgroup” should be changed to “low growing berry subgroup except 

cranberry.”

 Revised labels are required for EPA Reg. No.7969-199 (Pristine Fungicide) and EPA 

Reg. No.7969-251 (Pagent® Fungicide). A PF5 respirator needs to be proposed on these 

labels.

3.0 Introduction

Pyraclostrobin belongs to the strobilurin class of fungicides (β-methoxyacrylate class of 

compounds). Strobilurins are synthetic analogs of a natural antifungal substance which inhibit 

spore germination, mycelial growth, and sporulation of the fungus on the leaf surface.

Pyraclostrobin is currently registered on barley, berries, Brassica vegetables, bulb vegetables, 

citrus, corn (field, pop and sweet), cotton, cucurbit vegetables, fruiting vegetables, grapes, grass 

grown for seed, hops, leafy vegetables, legumes (dried peas and beans, succulent shelled peas 

and beans), mint, oats, oilseed group (canola & flax), peanuts, pistachios, pome fruits, potatoes, 

root vegetables, rye, soybean, strawberries, stone fruits, sugar beets, sunflower, tropical fruits 

(avocado, black sapote, canistel, mamey sapote, mango; papaya, sapodilla, & star apple), 

tuberous and corm vegetables, tree nuts, and wheat, as well as seed treatment on oats, canola, 

and flax, and residential and golf course turf. 

The proposed actions of pyraclostrobin are as follows: 1) BASF Corporation (BASF) is 

proposing a new agricultural use (PP# 2F8038) on sugarcane; 2) The Interregional Research 

Project No. 4 (IR-4) is proposing new agricultural uses (PP# 2F8069) on artichoke, Belgium

endive, and persimmon; 3) BASF is proposing a new greenhouse tomato use for commercial 

production and for tomato transplants grown for the home consumer market; 4) Bonide Products 

is proposing a new use on residential fruit and nut trees; and 5) BASF is proposing new uses on 

residential ornamentals and landscape gardens. Additionally, crop group expansions/revisions 

were requested for the bulb vegetable group 3-07, fruiting vegetable 8-10, citrus fruit group 10-

10, pome fruit group 11-10, berry subgroups 13-07A, B, F, and G, and oilseed group 20.
Page 14 of 58

3.1 Chemical Identity

TABLE 3.1. Pyraclostrobin Nomenclature.

Chemical Structure

Common name Pyraclostrobin

Company experimental name BAS 500 F

IUPAC name methyl 2-[1-(4-chlorophenyl)pyrazol-3-yloxymethyl]-N-methoxycarbanilate

CAS name methyl N-[2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]-Nmethoxycarbamate

CAS registry number 175013-18-0

End-use product (EP) Headline® EC Fungicide, EPA Reg. No. 7969-186.

Cabrio® EG fungicide, EPA Reg. No. 7969-187.

Pristine® fungicide, EPA Reg. No. 7969-199.

Headline® SC fungicide, EPA Reg. No. 7969-289.

3.2 Physical/Chemical Characteristics

Pyraclostrobin has a log octanol/water partition coefficient (log Kow) of 3.99. Pyraclostrobin has 

a molecular weight of 387.82 g/mol; therefore, the potential to cross biological barriers is 

somewhat limited. If released to air, a low vapor pressure of 1.9×10

-8 mm Hg at 20 oC limiting 

the potential for volatilization. The physiochemical properties of pyraclostrobin are summarized 

in Appendix B. 

3.3 Pesticide Use Pattern

Sugarcane

BASF is proposing the use of Headline® Fungicide, Headline® SC Fungicide, MultivaTM 

Fungicide, and BAS 556 SC Fungicide on sugarcane at a maximum single application rate 

ranging from 0.13 to 0.20 lb ai/A using ground, aerial, or chemigation equipment. Each product 

may be applied 4 times per year at a maximum yearly application rate of 0.52 to 0.78 lb ai/A/yr 

and a 14-day retreatment interval.

Headline® Fungicide (EPA Reg. No. 7969-186) and Headline® SC Fungicide (EPA Reg.

No.7969-289) are suspension concentrate (SC) fungicides containing 23.6% pyraclostrobin. 

MultivaTM Fungicide (EPA Reg. No.7969-247) and BAS 556 SC Fungicide (EPA Reg. No.7696-

291) are multiple active ingredient (MAI) SC fungicides containing 12% pyraclostrobin and 

7.4% metconazole, and 13.64% pyraclostrobin and 5.14% metconazole, respectively.

Globe artichoke, Belgium endive, and persimmon

IR-4 is proposing the use of Pristine Fungicide on globe artichokes, Belgium endive, and 

persimmons. Pristine Fungicide (EPA Reg. No.7969-199) is a multiple active ingredient (MAI)

N

N

Cl

O

N O

H3C

O

OCH3
Page 15 of 58

water dispersible granular (WDG) fungicide containing 12.8% pyraclostrobin and 25.2% 

boscalid. Belgium endive may be treated at a maximum rate of 0.013 lb ai/1000 lb roots prior to 

cold storage and 0.014 lb ai/70 ft2prior to forcing, each at one application per season. The 

maximum single application rate for artichoke and persimmon is 0.18 lb ai/A using aerial, 

ground, or chemigation equipment. Pristine may be applied to artichoke and persimmon 3 times 

per crop cycle at a maximum crop-cycle application rate of 0.55 lb ai/A/yr. 

Greenhouse tomato use for commercial production and for tomato transplants grown for the 

home consumer market

BASF is proposing the use of Pagent® Fungicide on greenhouse grown tomatoes. Pagent® 

Fungicide label (EPA Reg. No.7969-251) is a MAI WDG fungicide containing 12.8% 

pyraclostrobin and 25.2% boscalid. Pagent may be applied at a maximum single application rate 

of 0.18 lb ai/A (or 0.0018 lb ai/gal). Pagent may be applied 3 times per crop cycle at a maximum 

crop-cycle application rate of 0.55 lb ai/A (or 0.0055 lb ai/gal). Handlers may apply Pagent 

using handheld equipment. 

Residential fruit and nut trees

Bonide Products is proposing a new product, Bonide® Fruit Tree Spray Concentrate (FT09), for 

use on home orchard fruit and nut trees. Bonide® Fruit Tree Spray Concentrate (EPA Reg. No.

4-UII) is a MAI SC fungicide containing 0.500% lambda-cyhalothrin, 3.06% pyraclostrobin, and 

5.622% boscalid. The maximum single application rate is 0.12 lb ai/A with no more than 4 or 5 

applications per year, depending on the tree type. The retreatment interval ranges from 7 to 10 

days. Residential handlers may apply FT09 using handheld spray equipment.

Residential ornamentals and landscape gardens

BASF is proposing a new product, Homeowner Garden Spray Fungicide, for use on residential 

ornamentals and landscape gardens via a residential applicator. Homeowner Garden Spray

Fungicide (EPA Reg. No. 7969-GLG) is a MAI SC fungicide containing 9.0% pyraclostrobin 

and 18.0% boscalid. The maximum single application rate for this product is 0.0016 lb ai/gal via 

residential handheld spray equipment or hose-end sprayers.

The proposed agricultural labels require occupational handlers to wear the following personal 

protective equipment (PPE): long-sleeved shirts, long pants, chemical resistant gloves, and 

coveralls in a few cases. The 12 hour restricted entry interval (REI) listed on the labels is 

appropriate. 

The proposed uses of pyraclostrobin are summarized in Table 3.3.
Page 16 of 58

Table 3.3. Use Profile for Proposed Pyraclostrobin Uses

Proposed

Use

Product Formulation

[EPA Reg. No.]

Application 

Equipment

Max. Single 

Applic. Rate 

(lb ai/A)

Max. 

No. 

Applic. 

Per 

Season

Max. 

Seasonal 

Applic. 

Rate 

(lb ai/A/yr)

PHI 

(days)

Use Directions and 

Limitations

Sugarcane

Headline® Fungicide 

[EPA Reg. No. 7969-186]

SC 23.6% pyraclostrobin

Headline® SC Fungicide 

[EPA Reg No.7969-289]

SC 23.3% pyraclostrobin

Ground, Aerial, or 

Chemigation

0.20 4 0.78 14

Do not make more than 

two sequential 

applications. Continue 

treatment on a 14 to 28 

day interval.

MultivaTM Fungicide 

[EPA Reg. No.7969-247]

SC 12% pyraclostrobin

0.13 4 0.52 14

Do not make more than 

two sequential 

applications. Continue 

treatment on a 14 to 28 

day interval.

BAS 556 SC Fungicide 

[EPA Reg. No.7696-291]

SC 13.64% pyraclostrobin

0.19 4 0.76 14

Do not make more than 

two sequential 

applications. Continue 

treatment on a 14 to 28 

day interval.

Globe 

Artichoke

Persimmon

Pristine Fungicide 

[EPA Reg. No.7969-199]

WDG 12.8% 

pyraclostrobin

Ground, Aerial, or 

Chemigation 0.18 3 0.55 0

Continue treatment on a 7 

to 14 day interval.

Belgium 

endive

Make one app as a 

spray to roots when 

brought into cold 

storage prior to 

forcing. Apply again 

at the beginning of 

forcing after the roots 

have been packed in 

forcing trays

Prior to cold 

storage:

0.013 lb 

ai/1000 lb roots

1

19

Prior to Cold Storage: 

make one app as a spray 

to the roots as they move 

along a conveyor belt 

used to bring the roots 

from field transportation 

into cold storage bins.

Prior to 

forcing: 

0.014 lb 

ai/70ft2 of 

forcing tray

1

Prior to Forcing: make 

one app as a spray to 

roots at the beginning of 

forcing, after they have 

been packed into forcing 

trays.

Greenhouse 

tomatoes

Pagent® Fungicide

[EPA Reg. No.7969-251]

WDG 12.8% 

pyraclostrobin

Chemigation, 

Ground, or

Handheld spray 

equipment

0.18 lb ai/A

or

0.0018 lb 

ai/gal 

3

0.55 0

For commercial 

production :

Apply as a foliar spray in 

a minimum of 100 gal/A 

water volume. 

Allow at least 7 days 

between applications.

Do not make more than 

one application before 

alternations to a fungicide 

with a different mode of 

action for at least on 

application
Page 17 of 58

Table 3.3. Use Profile for Proposed Pyraclostrobin Uses

Proposed

Use

Product Formulation

[EPA Reg. No.]

Application 

Equipment

Max. Single 

Applic. Rate 

(lb ai/A)

Max. 

No. 

Applic. 

Per 

Season

Max. 

Seasonal 

Applic. 

Rate 

(lb ai/A/yr)

PHI 

(days)

Use Directions and 

Limitations

0.14 lb ai/A

or

0.0014 lb 

ai/gal 

0.42 NA

For tomato transplants 

grown for the home 

consumer market:

Do not exceed 100 gal/A 

spray volume.

Allow at least 7 days 

between applications.

Do not use in transplant 

production for 

commercial field-grown 

tomatoes.

Do not apply more than 2 

consecutive applications 

in any crop production 

cycle.

Residential 

fruit and nut 

trees

Bonide® Fruit Tree Spray 

Concentrate (FT09)

[EPA Reg. No.4-UII]

SC 3.06% pyraclostrobin

Handheld spray 

equipment

0.0041 lb ai/gal

0.0000028 lb 

ai/ft2

0.12 lb ai/A

Pome 

and 

Tree 

nuts: 4

Stone: 

5

Pome: 

21

Stone: 

14

Almon

ds: 25

Tree 

Nuts: 

14

Apply thoroughly as a 

foliar cover spray to both 

sides of plant leaves and 

surfaces. Spray leaf 

surfaces to the point of 

drip but do not exceed 2 

fl oz of product per 

1,500ft2

Residential 

ornamentals

Homeowner Garden Spray 

Fungicide 

[EPA Reg. No. 7969-

GLG]

SC 9.0% pyraclostrobin

Handheld spray 

equipment

0.0016 lb ai/gal

0.16 lb a/A1

6 NA

For manual spray 

applications: spray until 

foliage is wet.

For hose-end sprayers: 

typically hose-end 

applicators are designed 

to deliver the desired dial 

setting per gallon of 

water in 30 seconds.

Retreatment interval is 14 

days.

1 Assumed 100 gallons treats 1 acre based on other similar labels; HED recommends that the Homeowner Garden Spray Fungicide (EPA Reg 

No. 7969-GLG) label should be clarified by including the spray volume (i.e., number of gallons of spray treated per acre). This information is 

needed so that the application rate can be presented in terms of lbs ai/A as well as, lbs ai/gal (which is currently on the label). 

3.4 Anticipated Exposure Pathways

The Registration Division has requested an assessment of human health risk to support proposed 

new uses of pyraclostrobin on the following: 1) agricultural crops sugarcane, artichoke, Belgium

endive, and persimmon; 2) greenhouse tomato use for commercial production and for tomato 

transplants grown for the home consumer market; 3) residential fruit and nut trees; and 4) 

residential ornamentals and landscape gardens. Humans may be exposed to pyraclostrobin in 

food and drinking water, since pyraclostrobin may be applied directly to growing crops and 

application may result in pyraclostrobin reaching surface and ground water. There are residential 
Page 18 of 58

uses of pyraclostrobin so there is exposure to residential handlers and those entering treated areas 

following application. In occupational settings, applicators may be exposed while handling 

pyraclostrobin. There is a potential for post-application exposure for workers re-entering treated 

fields and residents re-entering treated areas. 

Risk assessments have been completed for proposed and existing uses of pyraclostrobin. This 

risk assessment considers all of the aforementioned exposure pathways based on the proposed 

new uses of pyraclostrobin, but also considers existing uses of pyraclostrobin, particularly in the 

dietary and residential exposure assessments. 

3.5 Consideration of Environmental Justice

Potential areas of environmental justice concerns, to the extent possible, were considered in this 

human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions 

to Address Environmental Justice in Minority Populations and Low-Income Populations," 

(http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf. As a part of every pesticide risk 

assessment, OPP considers a large variety of consumer subgroups according to well-established 

procedures. In line with OPP policy, HED estimates risks to population subgroups from 

pesticide exposures that are based on patterns of that subgroup’s food and water consumption, 

and activities in and around the home that involve pesticide use in a residential setting. 

Extensive data on food consumption patterns are compiled by the U.S. Department of 

Agriculture’s National Health and Nutrition Examination Survey, What We Eat in America, 

(NHANES/WWEIA) and are used in pesticide risk assessments for all registered food uses of a 

pesticide. These data are analyzed and categorized by subgroups based on age and ethnic group. 

Additionally, OPP is able to assess dietary exposure to smaller, specialized subgroups and 

exposure assessments are performed when conditions or circumstances warrant. Whenever 

appropriate, non-dietary exposures based on home use of pesticide products and associated risks 

for adult applicators and for toddlers, youths, and adults entering or playing on treated areas 

post-application are evaluated. Further considerations are currently in development as OPP has 

committed resources and expertise to the development of specialized software and models that 

consider exposure to bystanders and farm workers as well as lifestyle and traditional dietary

patterns among specific subgroups.

4.0 Hazard Characterization and Dose-Response Assessment

Pyraclostrobin, a strobilurin fungicide, blocks fungal growth by disrupting mitochondrial 

respiration through inhibiting Complex III electron transfer at the Cytochrome bc1 (ubiquinol 

oxidase) Q0 site. There are no mammalian molecular data to specifically show this mode of 

action in the test animals. 

4.1 Toxicology Studies Available for Analysis

The pyraclostrobin toxicity database is complete. The toxicity studies available for risk 

assessment include an acute toxicity battery; subchronic toxicity studies (oral, dermal, and 

inhalation) in rats, dogs or rabbits; chronic toxicity studies in dogs and rats; carcinogenicity

studies in mice and rats; developmental toxicity studies in rats and rabbits; a 2-generation 
Page 19 of 58

reproduction study in rats; a battery of mutagenicity studies; acute neurotoxicity studies in the 

rat; metabolism studies in rats; in vivo dermal penetration studies in rats, and an immunotoxicity

study in mice.

4.2 Absorption, Distribution, Metabolism and Excretion (ADME)

The available ADME data in rats indicated that orally-administered radiolabeled pyraclostrobin 

exhibits fast yet modest absorption, broad distribution with no specific tissue accumulation, 

extensive metabolism, and fast body clearance. There was no evidence of bioaccumulation.

The data collected in male and non-pregnant female rats at two different dose levels (5 and 50 

mg/kg) suggest a time to peak plasma levels (tmax) of 8.0/0.5 hrs [M/F] with absorption of 35% 

of the orally administered dose (AD). The plasma elimination half-life (t1⁄2) was biphasic at the 

low-dose with the initial t1⁄2 of 9.0/10.5 hrs [M/F] and the terminal t1⁄2 of 37.5/31.6 hrs [M/F]; at 

the high-dose the t1⁄2 was 20.7/19.7 hrs [M/F]. Pyraclostrobin was rapidly and widely distributed 

in tissues. The highest levels of radioactivity were measured in the liver, thyroid, kidney, lungs, 

adrenal glands, and pancreas; radioactivity was higher in females than in males. Pyraclostrobin 

levels in the tissues decreased substantially over the first 24 hours and was essentially complete 

after 72 hours; feces was the primary route of elimination (>79% AD). There were no significant 

dose- or sex-dependent differences in tissue distribution or route of elimination.

Pyraclostrobin was extensively metabolized, resulting in 33 metabolites, in both male and female 

rats. Pyraclostrobin underwent 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. The most abundant metabolite was 500M08

which resulted from N-demethoxylation and hydroxylation of the pyrazol ring. The parent was 

quantified along with an N-demethylated metabolite and was less than 14% AD.

4.2.1 Dermal Absorption

The Agency evaluated an available dermal penetration study, but it was deemed initially

unacceptable due to material on the dressings being unavailable for absorption. In 2003 

however, the HED re-evaluated the study and derived a dermal penetration rate of 14% (TXR# 

0051553; 10 FEB 2003). 

4.3 Summary of Toxicological Effects

The most consistently observed effects of pyraclostrobin exposure across species, genders, and 

treatment durations were diarrhea and decreased body weight, body weight gain, and food 

consumption. Pyraclostrobin also causes intestinal disturbance as indicated by increased 

incidence of diarrhea or duodenum mucosal thickening. These intestinal effects appeared to be 

related to the irritating action on the mucus membranes as demonstrated by irritation seen in the 

primary eye irritation study.

In the rat acute and subchronic neurotoxicity studies, neuropathology and behavior changes were 

not observed.
Page 20 of 58

In the rat and rabbit developmental toxicity studies, developmental toxicity (i.e. skeletal 

variations, post-implantation loss, and fetal resorption) occurred at doses greater than or equal to 

those doses causing maternal toxicity (i.e. diarrhea, decreased body weight, body weight gain, 

food consumption, and clinical signs of toxicity). In the reproduction studies (guideline and 

range-finding studies), systemic toxicity manifested as decreased body weight and body weight 

gain in both the parents and offspring; no reproductive toxicity was seen. 

Pyraclostrobin was classified by the Cancer Assessment Review Committee (CARC) as “Not 

Likely to be Carcinogenic to Humans” based on the lack of treated related increase in tumor 

incidence in adequately conducted carcinogenicity studies in rats and mice (CARC 01 FEB 

2007). Pyraclostrobin did not cause mutagenicity or genotoxicity in the in vivo and in vitro

assays nor did it cause immunotoxicity in T-cell dependent antibody response (TDAR) assays in 

mice with preliminary review.

Pyraclostrobin has moderate to low acute toxicity via the oral, dermal, and inhalation routes of 

exposure (Toxicity Categories II-IV). Pyraclostrobin is not a dermal sensitizer. However, 

pyraclostrobin was determined to have a low effect dermal and eye irritant (Toxicity Category

III).

4.4 Safety Factor for Infants and Children (FQPA Safety Factor)

For all assessment scenarios, the default 10X FQPA Safety Factor can be reduced to 1X because 

the toxicity database is complete and there is no neurotoxicity, and no residual uncertainty in the 

exposure data. Although there are indications of qualitative susceptibility, the points of 

departure are protective of the effects in the developing organism.

4.4.1 Completeness of the Toxicology Database

The toxicology database is complete, acceptable, and sufficient for assessing susceptibility to 

infants and children as required by FQPA.

4.4.2 Evidence of Neurotoxicity

There are no indications in any of the studies available that the nervous system is a target for 

pyraclostrobin. Effects seen in the acute and subchronic neurotoxicity studies in rats are 

considered to reflect perturbations in mitochondrial respiration leading to effects on energy

production.

In the absence of frank neurotoxicity or neuropathology findings in the neurotoxicity battery or 

elsewhere in the database, a developmental neurotoxicity study is not required.

4.4.3 Evidence of Sensitivity/Susceptibility in the Developing or Young Animal

There is no evidence that pyraclostrobin results in increased susceptibility in in utero rats or 

rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction 
Page 21 of 58

study. Although there is qualitative evidence of increased susceptibility in the prenatal 

development study in rabbits, HED did not identify any residual uncertainties after establishing 

toxicity endpoints and traditional UFs to be used in the risk assessment of pyraclostrobin. The 

degree of concern for prenatal and/or postnatal toxicity is low.

4.4.4 Residual Uncertainty in the Exposure Database

There are no residual uncertainties identified in the exposure databases. The acute dietary

exposure assessments were performed assuming 100% of the crops were treated with 

pyraclostrobin and tolerance-level or highest field trial residues. The chronic dietary exposure 

assessments were performed using average percent crop treated estimates and tolerance-level or 

highest field trial residues. EPA made conservative (protective) assumptions in the ground and 

surface water modeling used to assess exposure to pyraclostrobin in drinking water. EPA used 

similarly conservative assumptions to assess post-application exposure of adults and children as 

well as incidental oral exposure of children. The residential exposure assessment is based on the 

updated 2012 Residential SOPs employing surrogate study data, including conservative exposure 

assumptions based on Day 0 dermal/oral contact to turf and surfaces treated at the maximum 

application rate. These data are reliable and are not expected to underestimate risks to adults or 

children. The Residential SOPs are based upon reasonable “worst-case” assumptions are not 

expected to underestimate risk. Although some of the residue values used in the dietary

exposure assessment were refined, these assessments will not underestimate the exposure and 

risks posed by pyraclostrobin. 

4.5 Toxicity Endpoint and Point of Departure Selections

4.5.1 Dose-Response Assessment

A variety of oral toxicity studies were used for the different risk assessment scenarios including 

the rabbit developmental toxicity study, the acute neurotoxicity study in rats, the rat 

carcinogenicity study, and the 13-week study in dogs. In addition, the 28-day inhalation study in 

rats will now be used for short- and intermediate-term occupational and residential inhalation 

risk assessments. The endpoints in these studies are well characterized and are the most sensitive 

among available comparable toxicity studies in other species. All dietary endpoints (i.e., acute 

and chronic RfDs), are calculated from the respective study’s NOAEL after applying a 100-fold 

safety factor (10 X to account for interspecies extrapolation and 10X for intraspecies variation).

For all other scenarios, including dermal, inhalation, and incidental oral, an MOE approach will 

be used with a Level of Concern (LOC) at 100.

The selected endpoint from the acute neurotoxicity study of 300 mg/kg/day for the acute dietary

(general population) risk assessment is appropriate because the decreased body weight gain in 

males occurred during the first week after a single oral high dose of 1000 mg/kg.

The rabbit developmental toxicity study findings are used for endpoint selections for acute 

dietary (Females 13+) as well as for short- and intermediate-term dermal exposures. For the 

acute dietary endpoint (Females 13+), the rabbit developmental findings of increased 

resorptions/post-implantation loss at the LOAEL of 10 mg/kg/day are assumed to occur 
Page 22 of 58

following a single in utero exposure. These effects were dose-dependently increased at the next 

(high) dose of 20 mg/kg/day. The same study and developmental endpoint are used for shortand intermediate-term dermal exposures after applying a dermal absorption factor of 14%.

Additionally, the maternal endpoints of decreased body weight gain and decreased food intake 

and food efficiency were found at the LOAEL of 10 mg/kg/day. This selection mitigates any 

concern from the observed developmental toxicity findings in rabbits which are not assessed in 

the rat dermal toxicity study.

The rat carcinogenicity study findings are used for endpoint selections for chronic dietary and 

dermal exposures based on findings of decreased body weight/gain and kidney tubular 

casts/atrophy in both sexes in addition to liver necrosis and stomach lesions in males at the high 

dose (LOAEL) of 9.2 mg/kg/day. This study has the lowest NOAEL (3.4 mg/kg/day) in the 

most sensitive species following chronic exposure. The dermal absorption factors of 14% will 

be applied to the dermal long-term risk scenario.

The short- and intermediate-term incident oral exposures are from the subchronic toxicity study

in the dog, and are based increased incidence of diarrhea, clinical chemistry changes, duodenum 

mucosal hypertrophy, and decreased body weight and food intake/efficiency at a LOAEL of 12.9 

mg/kg/day, with an oral NOAEL of 5.8 mg/kg/day.

The short-, intermediate-, and long-term inhalation exposures are based on the 28-day inhalation 

toxicity study in rats which had dose-dependent adverse findings in the respiratory system and 

duodenum. The study’s oral equivalents NOAEL/LOAEL are 0.23/6.92 mg/kg/day

(corresponding to study’s air concentration of 0.001/0.03 mg/L air). The findings are well 

characterized in that the severity, frequency, and location (e.g., along the respiratory tract) are 

dose-dependent ranging from no effects at the NOAEL of 0.001 mg/L air to severe respiratory

effects and death at the highest dose of 0.3 mg/L air.

4.5.2 Recommendation for Combining Routes of Exposure for Risk Assessment

As per FQPA, 1996, when there are potential residential exposures to a pesticide, aggregate risk 

assessment must consider exposures from three major sources: oral, dermal and inhalation 

exposures. When common toxicity endpoints are selected for these routes of exposure they may

be aggregated. Aggregate assessments are required for acute and chronic dietary (food + water) 

exposures, and short-term residential exposures (i.e., chronic dietary plus incidental oral and 

dermal exposures).

Residential short-/intermediate-term dermal exposure for adults and toddlers were assessed using 

the NOAEL (5 mg/kg/day) from the rabbit developmental study. While the developmental effect 

of increased resorptions is not applicable to toddlers, it should be noted that the maternal 

NOAEL from this study is also 5 mg/kg/day, and is based on reduced body weight gain, food 

consumption, and food efficiency at the LOAEL of 10 mg/kg/day; this more relevant endpoint 

was used to assess toddler dermal exposure. For incidental oral ingestion, exposure was assessed 

using the endpoint from a 13-week feeding study in the dog. The NOAEL from this study is 5.8 

mg/kg/day, based on increased incidence of diarrhea, clinical chemistry changes, duodenum 

mucosal hypertrophy, and decreased body weight and food intake/efficiency at the LOAEL of 
Page 23 of 58

12.9 mg/kg/day. A common effect (i.e., decreased body weight gain, food intake, and food 

efficiency) was seen in the studies selected to evaluate toddler dermal and incidental oral 

ingestion exposure; therefore, route-specific MOEs were aggregated for toddlers. 

4.5.3 Cancer Classification and Risk Assessment Recommendation

Pyraclostrobin was classified by the Cancer Assessment Review Committee (CARC) as “Not 

Likely to be Carcinogenic to Humans” based on adequate carcinogenicity and mutagenicity

studies (CARC 01 FEB 2007).

4.5.4 Summary of Points of Departure and Toxicity Endpoints Used in Human Risk 

Assessment

Table 4.5.4.1: Summary of Toxicological Doses and Endpoints for use in Dietary and Non-Occupational Human Health 

Risk Assessments

Exposure Scenario Point of 

Departure (PoD)

Uncertainty / 

FQPA Safety 

Factors

RfD, PAD, Level 

of Concern for 

Risk Assessment

Study and Toxicological Effects

Acute Dietary

General population 

(including infants and 

children)

NOAEL = 

300 mg/kg/day

UFA = 10x

UFH = 10x

FQPA = 1x

aRfD =

3.0 mg/kg/day

aPAD = 

3.0 mg/kg/day

Acute Neurotoxicity – Rat

LOAEL = 1000 mg/kg/day based on 

decreased body weight gain in males.

Acute Dietary,

Females (13-49 years 

old)

NOAEL = 

5.0 mg/kg/day

UFA = 10x

UFH = 10x

FQPA = 1x

aRfD =

0.05 mg/kg/day

aPAD = 

0.05 mg/kg/day

Developmental Toxicity – Rabbit

LOAEL = 10.0 mg/kg/day based on 

developmental toxicity findings of 

increased resorptions.

Chronic Dietary NOAEL = 

3.4 mg/kg/day

UFA = 10x

UFH = 10x

FQPA = 1x

cRfD = 

0.034 mg/kg/day

cPAD = 

0.034 mg/kg/day

Carcinogenicity – Rat

LOAEL = 9.2 mg/kg/day based on 

decreased body weight/body weight 

gain, kidney tubular casts and atrophy 

in both sexes; increased incidence of

liver necrosis and erosion/ulceration of 

the glandular- stomach and forestomach in males.

Incidental Oral

Short Term 

(1-30 days)

Intermediate Term

(1-6 months)

Oral NOAEL = 

5.8 mg/kg/day

UFA = 10x

UFH = 10x

FQPA = 1x

Residential LOC 

for MOE = 100

Subchronic Toxicity – Dog

LOAEL = 12.9 mg/kg/day based on 

increased incidence of diarrhea, 

clinical chemistry changes, duodenum 

mucosal hypertrophy, and decreased 

body weight and food 

intake/efficiency.

Dermal 

Short Term 

(1-30 days)

Intermediate Term

(1-6 months)

Oral NOAEL = 

5.0 mg/kg/day

(Dermal 

Absorption Rate 

= 14%)

UFA = 10x

UFH = 10x

FQPA = 1x

Residential LOC 

for MOE = 100

Developmental Toxicity – Rabbit

LOAEL = 10.0 mg/kg/day based on 

developmental toxicity findings of 

increased resorptions and maternal 

toxicity based on decreased body 

weight gain and decreased food 

intake/efficiency.
Page 24 of 58

Table 4.5.4.1: Summary of Toxicological Doses and Endpoints for use in Dietary and Non-Occupational Human Health 

Risk Assessments

Exposure Scenario Point of 

Departure (PoD)

Uncertainty / 

FQPA Safety 

Factors

RfD, PAD, Level 

of Concern for 

Risk Assessment

Study and Toxicological Effects

Dermal

Long Term

(>6 months)

Oral NOAEL =

3.4 mg/kg/day

(Dermal 

Absorption Rat = 

14%)

UFA = 10x

UFH = 10x

FQPA = 1x

Residential LOC 

for MOE = 100

Carcinogenicity – Rat

LOAEL = 9.2 mg/kg/day based on 

decreased body weight/body weight 

gain, kidney tubular casts and atrophy 

in both sexes; increased incidence of

liver necrosis and erosion/ulceration of 

the glandular- stomach and forestomach in males.

Inhalation 

Short Term 

(1-30 days)

Intermediate Term

(1-6 months)

Long Term

(>6 months)

NOAEL = 

0.23 mg/kg/day

(Air 

Concentration = 

0.001 mg/L)

UFA = 10x

UFH = 10x

FQPA = 1x

Residential LOC 

for MOE = 100

Inhalation Toxicity – Rat

LOAEL = 6.9 mg/kg/day (air 

concentration = 0.03 mg/L) based on 

duodenum mucosal hyperplasia and 

respiratory system findings including 

alveolar histiocytosis and olfactory 

atrophy/necrosis in nasal tissue.

Cancer (oral, dermal, 

and inhalation)

Classification: “Not likely to be Carcinogenic to Humans” based on the absence of significant tumor 

increases in two adequate rodent carcinogenicity studies.

Point of Departure (PoD) = A data point or an estimated point that is derived from observed dose-response data and used to mark 

the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no 

observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from 

animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin 

of exposure. LOC = level of concern. N/A = not applicable.

Table 4.5.4.2: Summary of Toxicological Doses and Endpoints for use in Occupational Human Health Risk Assessments

Exposure Scenario Point of 

Departure (PoD)

Uncertainty / 

FQPA Safety 

Factors

Level of 

Concern for 

Risk Assessment

Study and Toxicological Effects

Dermal 

Short Term 

(1-30 days)

Intermediate Term

(1-6 months)

Oral NOAEL = 

5.0 mg/kg/day

(Dermal 

Absorption Rate 

= 14%)

UFA = 10x

UFH = 10x

FQPA = 1x

Residential LOC 

for MOE = 100

Developmental Toxicity – Rabbit

LOAEL = 10.0 mg/kg/day based on 

developmental toxicity findings of 

increased resorptions and maternal 

toxicity based on decreased body 

weight gain and decreased food 

intake/efficiency.

Dermal

Long Term

(>6 months)

Oral NOAEL =

3.4 mg/kg/day

(Dermal 

Absorption Rat = 

14%)

UFA = 10x

UFH = 10x

FQPA = 1x

Residential LOC 

for MOE = 100

Carcinogenicity – Rat

LOAEL = 9.2 mg/kg/day based on 

decreased body weight/body weight 

gain, kidney tubular casts and atrophy 

in both sexes; increased incidence of

liver necrosis and erosion/ulceration of 

the glandular- stomach and forestomach in males.

Inhalation 

Short Term 

(1-30 days)

Intermediate Term

NOAEL = 

0.23 mg/kg/day

(Air 

Concentration = 

UFA = 10x

UFH = 10x

FQPA = 1x

Residential LOC 

for MOE = 100

Inhalation Toxicity – Rat

LOAEL = 6.9 mg/kg/day (air 

concentration = 0.03 mg/L) based on 

duodenum mucosal hyperplasia and 

respiratory system findings including 
Page 25 of 58

Table 4.5.4.2: Summary of Toxicological Doses and Endpoints for use in Occupational Human Health Risk Assessments

Exposure Scenario Point of 

Departure (PoD)

Uncertainty / 

FQPA Safety 

Factors

Level of 

Concern for 

Risk Assessment

Study and Toxicological Effects

(1-6 months)

Long Term

(>6 months)

0.001 mg/L) alveolar histiocytosis and olfactory 

atrophy/necrosis in nasal tissue.

Cancer (oral) Classification: “Not likely to be Carcinogenic to Humans” based on the absence of significant tumor 

increases in two adequate rodent carcinogenicity studies.

Point of Departure (PoD) = A data point or an estimated point that is derived from observed dose-response data and used to mark 

the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no 

observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from 

animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

FQPA SF = FQPA Safety Factor. MOE = margin of exposure. LOC = level of concern. N/A = not applicable.

5.0 Dietary Exposure and Risk Assessment 

5.1 Residues of Concern Summary and Rationale

The residues of concern for dietary risk assessment and the tolerance expression are summarized 

in Table 5.1 (HED MARC, DP278044, L. Cheng, 10/9/01). HED has concluded that the 

residues of concern in plants include pyraclostrobin and its desmethoxy metabolite (BF 500-3)

for purposes of tolerance enforcement and risk assessment. For livestock commodities, HED has 

determined that for purposes of tolerance setting and risk assessment the residues of concern 

consist of 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). 

For drinking water, the residue of concern for pyraclostrobin is the parent only.

Table 5.1. Summary of Metabolites and Degradates to be included in the Risk Assessment and Tolerance

Expression.

Matrix Residues included in Risk 

Assessment

Residues included in 

Tolerance Expression

Plants

Primary Crop parent, BF 500-3 parent, BF 500-3

Rotational Crop parent, BF 500-3 parent, BF 500-3

Livestock

Ruminant parent, BF 500-5, BF 500-8 parent, BF 500-5, BF 500-8

Poultry parent, BF 500-5, BF 500-8 parent, BF 500-5, BF 500-8

Drinking Water parent only Not Applicable

5.2 Food Residue Profile

Field trial data on sugarcane (MRID 48237401), artichoke (MRID 48897401), Belgium endive

(MRID 48897402), and persimmon (MRID 48897403) have been submitted to support the 

proposed tolerances. These data are adequate to support dietary risk assessment as well as the 

proposed tolerances of pyraclostrobin on sugarcane, artichoke, Belgium endive, and persimmon. 
Page 26 of 58

The number and geographic distribution of the field trials are adequate. The analytical method 

was demonstrated to be acceptable via concurrent recoveries of fortified control samples. The 

intervals of frozen storage of samples are covered by previous storage stability studies, and no 

corrections for loss of residue are needed. The trials were conducted according to the proposed 

labels (single and seasonal application rates, PHI). Summaries of the residue data from the crop 

field trials are presented in Appendix D, Table D-1 through D-4.

A processing study was submitted for sugarcane (MRID 48237401). The study is adequate. 

Residues of pyraclostrobin and BF 500-3 did not concentrate in blackstrap molasses or refined 

sugar, relative to the concentration in the raw agricultural commodity (sugarcane). Therefore, 

tolerances are not necessary for these processed commodities.

Greenhouse Grown Tomato Transplants Grown for Home Consumer Market

BASF Corporation has requested the addition of greenhouse tomato use for commercial 

production and for tomato transplants grown for the home consumer market to the PageantTM 

Fungicide label (EPA Reg. No. 7969-251). This product is identical to PristineTM Fungicide 

(EPA Reg. No. 7969-199), which includes use on greenhouse tomatoes, but does not cover 

tomato transplants for consumers or use of lath type structures. No residue chemistry data were 

submitted with this request.

Residues on tomato fruits from such use of PristineTM Fungicide (EPA Reg. No. 7969-199) for 

tomato transplants in green house, lath house, and other production structures would be expected 

to be less than those found in the greenhouse trials supporting the approved greenhouse use. The 

existing tolerance for fruiting vegetables will cover the requested new uses of the PageantTM 

Fungicide (EPA Reg. No. 7969-251) formulation.

Residential Use of FT09 (EPA File Symbol 4-UII) on Pome Fruit, Stone Fruit, and Tree Nuts

The submitted use directions are sufficient to allow for evaluation of the proposed residential use 

of FT09 based on comparison to the existing BASF Pristine®label for agricultural uses. The 

BASF formulation is a water dispersible granule. It is a solid material that forms a dispersion 

when mixed with water. The Bonide formulation is a suspension concentrate or suspension of 

solid materials in water. It also will form a dispersion when mixed with water. The formulations 

are expected to behave similarly when applied in the same manner (same rate) to crops. The 

Organization of Economic Cooperation and Development (OECD) Crop Field Trial Guidance 

recognizes such formulations as yielding the same residues at PHIs greater than 7 days. All 

relevant Bonide PHIs exceed 7 days, and therefore the resulting residues based on formulation 

will not be greater than residues from the BASF formulation.

The PHIs for the Bonide formulation are equal to or longer/greater than the BASF Pristine® 

formulation PHIs. Therefore, residues from use on the Bonide formulation are anticipated to be 

no more than or less than residues from the BASF formulation, based on comparison of the PHIs. 

The application rates (lbs ai/A) for the Bonide formulation, both per application and per season, 

are approximately equal to or less than the corresponding application rates for the BASF 

Pristine® formulation. Therefore, residues from the use of the Bonide formulation are 

anticipated to be no more than or less than residues from the BASF formulation, based on 
Page 27 of 58

comparison of the application rates.

Residential use of the Bonide FT09 per the proposed label will not yield residues in excess of 

those from agricultural use of the BASF formulation Pristine®per the approved label. 

Livestock

The livestock feedstuff associated with the proposed uses in these petitions is sugarcane 

blackstrap molasses. Sugarcane blackstrap molasses is a carbohydrate concentrate (CC) feed 

item for dairy cattle and beef cattle and may comprise up to 10% of the diet of each. The 

processing factor for conversion of sugarcane to blackstrap molasses is 0.3X (S. Funk, 

48237401.der2). No significant changes to the dietary burden result from the present 

considerations. No changes to the existing livestock tolerances are indicated. Additionally, 

sugarcane blackstrap molasses is not a poultry or swine feed item.

Rotational Crops

An adequate confined rotational crop study was reviewed in PP#0F6139 (DP278668, L. Cheng, 

11/28/01). The study showed that the metabolism of pyraclostrobin in rotated crops is similar 

but more extensive than that in primary crops. Pyraclostrobin undergoes demethoxylation to 

yield BF 500-3, followed by further degradation to medium polar and polar metabolites, and 

subsequent conjugation reactions and incorporation into natural products. The HED MARC has 

determined that the residues of concern in rotational crops consist of pyraclostrobin and 

metabolite BF 500-3.

A limited field rotational crop study was reviewed in PP#0F6139. The results indicate that 

residues of pyraclostrobin and its metabolite BF 500-3 were each less than the method LOQ 

(<0.02 ppm) in/on rotational crop matrices (radish, roots and tops; cabbage, with and without 

wrapper leaves; and wheat forage, hay, and grain) planted 14 days following the last of six 

sequential foliar applications to the primary crop, cucumbers, of the 2 lb/gal EC formulation at 

0.19 - 0.20 lb ai/A/application. Residues of pyraclostrobin in/on one sample of wheat straw from 

the CA test site were at the LOQ (0.02 ppm), but residues of pyraclostrobin in/on a replicate 

sample from the same plot were below the LOQ (0.012 ppm) for an average residue of <0.02 

ppm. Residues of metabolite BF 500-3 were nondetectable (<0.02 ppm) in/on all samples of 

wheat straw.

The registered pyraclostrobin end-use product labels presently specify a 14-day plantback 

interval restriction for all crops that are not registered. 

5.3 Water Residue Profile

The drinking water residues used in the dietary risk assessment were provided by EFED 

(D403871, D405066, F. Khan, 04/04/2013) and incorporated directly into the dietary assessment. 

Water residues were incorporated in the DEEM-FCID into the food categories “water, direct, all 

sources” and “water, indirect, all sources.”

For surface water, the EDWCs were generated using EFED’s standard suite of models. Pesticide

Root Zone Model (PRZM v3.12.2, May 12, 2005) and Exposure Analysis Modeling System 
Page 28 of 58

(EXAMS v2.98.04.06, Apr. 25, 2005) are simulation models coupled with the input shell 

PRZM/EXAMS (PE v5.0, Nov. 15, 2006) to generate EDWCs of pyraclostrobin residues that 

may occur in surface water for drinking water. For ground water, Screening Concentration in 

Ground Water (SCI-GROW v2.3, Jul. 29, 2003) is a regression model used as a screening tool to 

estimate pesticide concentrations found in ground water used as drinking water. In addition, Tier 

1 ground water EDWCs for pyraclostrobin, resulting from its use on various crops were also 

derived using the PRZM-GW model (Pesticide Root Zone Model for Groundwater, version 1.0, 

August 31, 2012), with the GW-GUI (Graphical User Interface, version 1.0, August 31, 2012). 

For the proposed uses of pyraclostrobin, the use on fruiting vegetables resulted in the highest 

surface water concentrations at 16.6 μg/L for the 1-10 year peak value from ground application 

and at 1.1 μg/L for the 1-10 annual year average value from aerial application. The acute and 

chronic EDWCs resulting from the proposed application uses are lower than the EDWCs for 

surface water in the previously recommended drinking water assessments for pyraclostrobin for 

turf uses (USEPA 2007 D389729+). Since the EDWCs for surface water for proposed uses are 

lower than the previously recommended EDWCs for this chemical, the EDWCs for surface water 

will not supersede the EDWCs previously recommended for turf use.

Table 5.3 provides a summary of the estimated concentrations of pyraclostrobin in surface water. 

In the acute analysis, the 1-in-10 year peak surface water value of 35.6 ppb was used and in the 

chronic analysis the surface water value of 2.3 ppb was used. Estimates of pyraclostrobin 

concentration in drinking water were less for ground water sources. The models and their 

descriptions are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/. 

Table 5.3. EDWCs of Pyraclostrobin 

Crop Scenario PRZM/EXAMS Estimated Concentrations in Surface Water (g/L)

Acute1(μg/L) Chronic (μg/L)

Surface Water

NJ Nursery (no irrigation) Turf 35.6 2.3

Ground Water2

N/A 0.06 0.02

1 These are the highest EDWCs for previously evaluated use scenarios and the estimated acute and annual average surface water 

concentrations were 35.6 and 2.3 μg/L respectively. Previously estimated ground water concentrations for acute was 0.02 μg/L 

2007, D389729. 

2 EDWCs based on PRZM-GW model

5.4 Dietary Risk Assessment

5.4.1 Description of Residue Data Used in Dietary Assessment

The dietary exposure analysis incorporates all current and proposed tolerances for residues of 

pyraclostrobin, including its metabolites and degradates. 

A slightly refined acute dietary exposure assessment was performed for pyraclostrobin. The 

analysis used tolerance-level residues or highest field trial residues and empirical or default 

processing factors. Experimentally derived processing factors were used for fruit juices, tomato, 

sugarcane, and wheat commodities. For all other processed commodities, DEEM default 
Page 29 of 58

processing factors were assumed. Estimated drinking water concentrations (EDWCs) were also 

used. The estimated acute drinking water concentration for pyraclostrobin (0.0356 ppm) was 

calculated based on a turf scenario for surface water. 

A refined chronic dietary analysis was conducted for this assessment, since some refinement was 

needed for the aggregate assessment. The chronic dietary analysis included tolerance-level or 

average field trial residues, average percent crop treated estimates (2012) when available, and 

empirical processing factors. Screening level estimates of agricultural uses of pyraclostrobin 

were provided by the Biological & Economic Analysis Division (BEAD). Experimentally

derived processing factors were used for fruit juices, tomato, sugar cane, and wheat

commodities. For all other processed commodities, DEEM default processing factors were 

assumed. The estimated drinking water concentration for pyraclostrobin (0.0023 ppm) was 

calculated based on a turf scenario for surface water. 

Pyraclostrobin is classified as “not likely to be carcinogenic to humans”. Therefore, a cancer 

dietary exposure assessment was not conducted.

5.4.2 Percent Crop Treated Used in Dietary Assessment

The acute dietary assessment was based on 100% crop treated (%CT).

BEAD provided updated percent crop treated information for pyraclostrobin (S. Haddad, 

11/18/2012). For the chronic analyses, average %CT was incorporated. One hundred percent 

crop treated was assumed for commodities with no %CT information, including sugarcane and 

Belgium endive. 

The following average percent crop treated estimates were used in the chronic dietary risk 

assessments for the crops that are currently registered for pyraclostrobin: almonds 40%; apples 

15%; apricots 25%; barley 10%; green beans 5%; blueberries 45%; broccoli 5%; cabbage 10%; 

caneberries 50%; cantaloupes 15%; carrots 35%; cauliflower 2.5%; celery 2.5%; cherries 50%; 

corn 10%; cotton 2.5%; cucumber 5%; dry beans/peas 10%; garlic 15%; grapefruit 25%; grapes 

30%; hazelnuts (filberts) 15%; lemons 2.5%; lettuce 5%; nectarines 10%; onions 20%; oranges 

5%; peaches 20%; peanuts 25%; pears 15%; green peas 5%; pecans 2.5%; peppers 10%; 

pistachios 30%; plums/prunes 5%; potatoes 15%; pumpkins 20%; soybeans 5%; spinach 5%; 

squash 15%; strawberries 65%; sugar beets 45%; sweet corn 5%; tangelos 15%; tangerines 10%; 

tomatoes 25%; walnuts 1%; watermelons 30%; wheat 5%. 

5.4.3 Acute Dietary Risk Assessment

The results of the acute dietary analysis for food and drinking water indicate that acute dietary

risks are not of concern (<100% of the aPAD) for the U.S. population and all subgroups.

Combined dietary exposure from food and drinking water at the 95th percentile of exposure for 

the U.S. population is equivalent to 1.5% of the acute Population Adjusted Dose (aPAD). The 

population subgroup with the highest estimated acute dietary exposure to pyraclostrobin is 

females 13-49 years, with an estimated exposure of 87% of the aPAD at the 95th percentile.
Page 30 of 58

5.4.4 Chronic Dietary Risk Assessments

The results of the refined chronic dietary (food and drinking water) analysis are below the 

Agency’s level of concern for all population subgroups. The dietary exposure for food and 

drinking water for the general U.S. population is 8.0% of the chronic Population Adjusted Dose 

(cPAD) and 27% of the cPAD for children 1-2 years old, the population subgroup with the 

highest estimated chronic dietary exposure to pyraclostrobin.

5.4.5 Summary Table

Table 5.4.5. Summary of Dietary Exposure and Risk for Pyraclostrobin Food & Drinking Water.

Population Subgroup

Acute Dietary

(95th Percentile) Chronic Dietary

Dietary Exposure 

(mg/kg/day) % aPAD

Dietary Exposure

(mg/kg/day) % cPAD

General U.S. Population 0.044721 1.5 0.002707 8.0

All Infants (< 1 year old) 0.061716 2.1 0.004353 13

Children 1-2 years old 0.083049 2.8 0.009206 27

Children 3-5 years old 0.074666 2.5 0.006204 18

Children 6-12 years old 0.044251 1.5 0.003525 10

Youth 13-19 years old 0.031506 1.0 0.001832 5.4

Adults 20-49 years old 0.041724 1.4 0.002224 6.5

Adults 50-99 years old 0.041722 1.4 0.002252 6.6

Females 13-49 years old 0.043481 87 0.002005 5.9

*The subpopulations with the highest risk estimates are bolded.

6.0 Residential (Non-Occupational) Exposure/Risk Characterization

The proposed residential uses for pyraclostrobin will result in residential handler and postapplication exposures. In addition, the existing use on residential turf (Insignia Fungicide label; 

EPA Reg. No. 7969-184) was reassessed in this document to reflect updates to HED’s 2012 

Residential SOPs2along with policy changes for body weight assumptions, since the revisions to

these exposures could impact the human health aggregate risk assessment for pyraclostrobin. 

Registered and proposed products do not lead to any residential handler or post-application risk 

estimates of concern.

 

2 Available: http://www.epa.gov/pesticides/science/residential-exposure-sop.html
Page 31 of 58

6.1 Residential Handler Exposure

The residential handler assessment includes short-term exposures via the dermal and inhalation 

routes. Exposures occur from treating gardens, trees, and turf. 

HED’s LOC for the MOE is defined by the uncertainty factors that are applied to the assessment. 

HED applies a 10X factor to account for variability among species and a 10X factor to account 

for variability within species. The total uncertainty factor that has been applied to the non-cancer 

assessment of pyraclostrobin is 100X for residential exposure. Residential exposure and risk 

resulting in MOEs greater than or equal to 100 will not be of concern to HED (LOC = 100). 

Summaries of the inhalation and dermal risk estimates for residential handlers are included in 

Table 6.1. The maximum application rate for each exposure scenario is presented as the worst 

case scenario. The residential handler dermal MOEs range from 740 (hose end turf application

of WDG formulation) to 13,000 (hose end sprayer application to trees using a liquid 

formulation). The residential handler inhalation MOEs range from 590 (manually pressurized 

handwand turf application of WDG formulation) to 3,400,000 (hose end sprayer application to 

trees using a liquid formulation). The dermal and inhalation risks to handlers are not of concern 

to HED for any of the residential handler scenarios.
Page 32 of 58

Table 6.1. Residential Handler Non-cancer Exposure and Risk Estimates for Pyraclostrobin.

Exposure Scenario Level of 

Concern

Dermal 

Unit 

Exposure 

(mg/lb ai)

Inhalation 

Unit 

Exposure 

(mg/lb ai)

Maximum 

Application Rate1

Area Treated or 

Amount 

Handled Daily2

Dermal Inhalation

Dose 

(mg/kg/day)3 MOE4 Dose 

(mg/kg/day)5 MOE6

Mixer/Loader/Applicator

Liquid Garden/Trees : 

manually pressurized handwand 100 63 0.018 0.0041 lb ai/gal 5 gal 0.0026 1,900 0.0000046 50,000

Liquid Garden/Trees : 

manually pressurized handwand 100 63 0.018 0.0000028 lb ai/ft2

1200 ft20.00043 12,000 0.00000076 300,000

Liquid Garden/Trees : 

hose-end sprayer 100 58 0.0014 0.0000028 lb ai/ft2

1200 ft20.00040 13,000 0.000000059 3,900,000

Liquid Garden/Trees : 

hose-end sprayer 100 58 0.0014 0.0041 lb ai/gal 11 gal 0.0053 940 0.00000079 290,000

Liquid Garden/Trees : 

backpack sprayer 100 130 0.14 0.0000028 lb ai/ft2

1200 ft20.00089 5,600 0.0000059 39,000

Liquid Garden/Trees : 

backpack sprayer 100 130 0.14 0.0041 lb ai/gal 5 gal 0.0054 920 0.000036 6,400

Liquid Garden/Trees : 

sprinkler can 100 58 0.0014 0.0000028 lb ai/ft2

1200 ft20.00040 13,000 0.000000059 3,900,000

Liquid Garden/Trees : 

sprinkler can 100 58 0.0014 0.0041 lb ai/gal 5 gal 0.0024 2,100 0.00000036 640,000

WDG Lawn/turf : 

manually pressurized handwand 100 69 1.1 0.0057 lb ai/gal 5 gal 0.0040 1,300 0.00039 590

WDG Lawn/turf :

hose-end sprayer 100 13.4 0.022 0.5 lb ai/A 0.5 A 0.0068 740 0.000069 3,300

WDG Lawn/turf :

backpack sprayer 100 69 1.1 0.0057 lb ai/gal 5 gal 0.0040 1,300 0.00039 590

WDG Lawn/turf : 

sprinkler can 100 13.4 0.022 0.000011 lb ai/ft2

1000 ft20.00031 16,000 0.0000032 73,000

1 Based on the proposed garden/tree use on Bonide FT09 label (EPA Reg. No. 4-UII) and registered turf use on Insignia® Fungicide label (EPA Reg. No. 7969-184).

2 Based on HED’s 2012 Residential SOPs (http://www.epa.gov/pesticides/science/residential-exposure-sop.html).

3 Dermal Dose = Dermal Unit Exposure (mg/lb ai) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled (A/day or gallons/day) × Dermal Absorption Factor (%) ÷ Body Weight 

(kg).

4 Dermal MOE = Dermal NOAEL (mg/kg/day) ÷ Dermal Dose (mg/kg/day).

5 Inhalation Dose = Inhalation Unit Exposure (mg/lb ai) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled (A/day or gallons/day) ÷ BW (kg).

6 Inhalation MOE = Inhalation NOAEL (mg/kg/day) ÷ Inhalation Dose (mg/kg/day).
Page 33 of 58

6.2 Post-Application Exposure

There is the potential for post-application exposure for individuals as result of being in an 

environment that has been previously treated with pyraclostrobin. Short-term dermal exposures 

were assessed for adults, youth 11 to 16 years old, and children 6 to 11 years old. Short-term 

dermal and incidental oral exposures were assessed for children 1 to <2 years old. A series of 

assumptions and exposure factors served as the basis for completing the residential postapplication risk assessment. Each assumption and factor is detailed in the 2012 Residential 

SOPs6.

Dislodgeable Foliar Residues

Chemical-specific dislodgeable foliar residue (DFR) data were previously submitted by the 

registrant to support earlier registration requests for food crops. An overview of each study was 

provided in a previous assessment (D269670, K. O’Rourke, 9/30/2002). Pyraclostrobin DFR

studies were conducted on peaches, peanuts, strawberries, grapes. The Canadian Pesticide 

Management Regulatory Agency (PMRA) performed the primary review of these data, and 

considered the results useful for risk assessment purposes; summaries of their reviews and a 

summary of the DFR study results is provided in a previous HED assessment (D269670, K. 

O’Rourke, 9/30/2002). 

It should be noted that PMRA only used the DFR data to calculate % dissipation per day and halflives. Therefore, HED went back to the initial study to calculate the DFR on day zero based on the 

results of the DFR study. The calculated DFR values on day zero were used in the post-application 

dermal assessments. The PA peach DFR data, which resulted in the highest DFR values of the three 

study sites, were used in the residential fruit/nut tree and garden assessments. The CA strawberry 

DFR data, which also resulted in the highest DFR values of the three study sites, were used in the 

residential exposure to retail tomato transplants. The DFR data used in this assessment are presented 

in Appendix F, Tables F-1 through F-3.

Turf Transferable Residues

Turf transferrable residue (TTR) data (MRID 45118725) are available from an earlier submission 

in support of a request for use on golf course turf. This study was not used in the previous turf 

exposure assessments because the study used an emulsifiable concentrate formulation, rather 

than the water dispersible granule formulation that is currently registered. The effect of 

formulation type on residue values can be significant. At that time, HED concluded that using 

the results from the TTR study may be under protective due to formulation effects (D298017, K. 

O’Rourke, 8/19/2004). However, HED has since determined that there is no statistical difference 

between residues resulting from liquid, wettable powder (applied as a spray), or water dispersible 

granular (applied as a spray) applications. Therefore, the residue data from the pyraclostrobinspecific TTR study were used in this assessment (2012 Residential SOPs6

). 

Combined Risks

Since the toxicological endpoints for dermal and incidental oral exposure routes are based on 

toxicity studies that have a common effect (i.e., decreased body weight gain and food efficiency), 

risk estimates have been combined for those routes. The incidental oral scenarios (i.e., hand-tomouth, object-to-mouth, and soil ingestion) should be considered inter-related and it is likely that 
Page 34 of 58

they occur interspersed amongst each other across time. Combining these scenarios with the 

dermal exposure scenario would be overly-conservative because of the conservative nature of 

each individual assessment. Therefore, the post-application exposure scenarios that were 

combined for children (1 to <2 years old) are the dermal and hand-to-mouth scenarios. This 

combination should be considered a protective estimate of children’s exposure to pesticides used 

on turf.

Summary of Residential Post-application Non-Cancer Exposure and Risk Estimates

All the short-term MOEs for each scenario are greater than the LOC of 100, and therefore, are 

not of concern.

Table 6.2. Residential Post-application Non-cancer Exposure and Risk Estimates for Pyraclostrobin.

Lifestage

Post-application Exposure Scenario

Application 

Rate1

Dose 

(mg/kg/day)2 MOEs3 Combined MOEs4

Use Site Route of Exposure

Adult

Tomato 

Transplants Dermal

0.18 lb ai/A

DFR = 0.379 

μg/cm2

0.0013 3,800

NA

Child (6-11 years old) 0.00077 6,500

Adult

Gardens Dermal

0.12 lb ai/A

DFR = 0.457 

μg/cm2

0.017 290

Child (6-11 years old) 0.010 490

Adult

Fruit and Nut 

Trees Dermal

0.12 lb ai/A

DFR = 0.457 

μg/cm2

0.0016 3,200

Child (6-11 years old) 0.00093 5,400

Adult

Lawn/Turf

Dermal

High contact 

0.5 lb ai/A

TTR = 0.035 

μg/cm2

0.019 260

Dermal

Mowing turf 0.00039 13,000

Dermal

Golfing 0.0015 3,300

Youth (11-16 years old)

Dermal

Mowing turf 0.00039 13,000

Dermal

Golfing 0.0015 3,300

Child (6-11 years old)

Dermal

Golfing 0.0018 2,800

Child (1< 2 years old)

Dermal

High contact 0.033 150

130

Incidental Oral

Hand to mouth 0.0048 1,200

Incidental Oral

Object to mouth 0.00015 40,000 NA

Incidental Oral

Soil Ingestion 0.000017 340,000 NA

1 Based on the proposed garden/tree use on Bonide FT09 label (EPA Reg. No. 4-UII); the proposed tomato transplant use on 

Pagent® Fungicide(EPA Reg. No.7969-251); and the registered turf use on Insignia® Fungicide label (EPA Reg. No. 7969-

184).

2 Dose (mg/kg/day) equations:
Page 35 of 58

Dermal Dose (turf)

Dermal Dose (gardens/trees)

Dermal Dose (tomato transplants)

Hand-to-Mouth Dose = hand residue loading (mg/cm2) × fraction of hand mouthed (0.127) × surface area of 1 hand (150 cm2) 

× exposure time (1.5 hrs/day) × # of replenishment intervals/hr (4 int/hr) × (1-((1-saliva extraction factor (0.5))^(Number of 

hand-to-mouth events per hour (13.9 events/hr) ÷ # of replenishment intervals/hr)) ÷ body weight (kg).

Object-to-Mouth Dose = object residue loading (μg/cm2) × unit conversion factor (0.001 mg/μg) × object surface area mouthed 

/ event (10 cm2/event) × exposure time (1.5 hrs/day) × # replenishment intervals/hr (4 int/hr) × (1-((1- saliva extraction factor 

(0.50))^(# Object-to-Mouth Events/hr (8.8 events/hr) ÷ # replenishment intervals/hr)) ÷ body weight (kg).

Soil Ingestion = soil residue (μg/g) × ingestion rate (50 mg/day) × conversion factor (0.000001 g/μg) ÷ body weight (11 kg).

TTR = 0.035 μg/cm2(based on pyraclostrobin TTR study)

3 Dermal MOE = Dermal NOAEL (mg/kg/day) ÷ Dermal Dose (mg/kg/day).

Incidental Oral MOE = Oral NOAEL (mg/kg/day) ÷ Incidental oral Dose (mg/kg/day).

4 Combined MOE = 1 ÷ (1/dermal MOE) + (1/incidental oral MOE), where applicable

6.3 Combined Residential Risk Estimates (Multiple Exposure Scenarios)

Because dermal post-application exposures to treated gardens, fruit or nut trees, tomato 

transplants, and turf could conceivably co-occur within the same day for adults and children 6 to 

11 years old, combined exposures from these scenarios were considered. However, all four of 

these use sites/scenarios involved different labeled products, and therefore, the probability of cooccurrence is considered improbable. Therefore, assessments of these combined exposures were 

not conducted. 

6.4 Residential Risk Estimates for Use in Aggregate Assessment

Since the toxicity effect from the inhalation route of exposure is different than the effect from the 

dermal route of exposure, inhalation and dermal exposures are not aggregated together. 

Therefore, separate inhalation and dermal aggregate assessments are evaluated. The scenarios 

with the highest exposures and corresponding lowest MOEs, provided in Tables 6.1 and 6.2,

reflect the residential risk estimates that are recommended for use in the short-term aggregate 

assessment for pyraclostrobin. Table 6.4 summarizes the residential risk estimates that are 

recommended for use in the short-term aggregate assessments for pyraclostrobin.

 The recommended residential inhalation exposure for use in the adult aggregate 

assessment reflects inhalation exposure from application of the WDG formulation to turf 

via manually pressurized handwand or backpack sprayer.

 The recommended residential dermal exposure for use in the adult aggregate assessment 

reflects dermal exposure from post-application activities on treated turf. 

 The recommended residential dermal exposure for use in the child (11-16 yr) aggregate 

assessment reflects dermal exposure from post-application golfing on treated turf. 

 The recommended residential dermal exposure for use in the child (6-11 yr) aggregate 

assessment reflects dermal exposure from post-application activities in treated gardens. 

 The recommended residential exposure for use in the children (1<2 years old) aggregate 

assessment reflects dermal and hand-to-mouth exposures from post-application exposure 

to treated turf.
Page 36 of 58

Table 6.4. Recommendations for the Residential Exposures for the Pyraclostrobin Short-term Aggregate Assessments.

Lifestage Route of Exposure Scenario Dose

(mg/kg/day)4 MOE5

Adult

Inhalation Applying WDG formulation to turf via manually 

pressurized handwand or backpack sprayer 0.00039 590

Dermal Post-application activities on treated turf 0.019 260

Child (11 -16 yr) Dermal Post-application golfing on treated turf 0.0015 3,300

Child (6-11 yr) Dermal Post-application activities in treated gardens 0.010 490

Child (1<2 years 

old)

Combined

(incidental oral + 

dermal)

Post-application activities on treated turf 0.038 130

6.5 Residential Bystander Post-application Inhalation Exposure

Based on the Agency's current practices, a quantitative post-application inhalation exposure 

assessment was not performed for pyraclostrobin at this time primarily because of the low vapor 

pressure (1.9 x 10-8 mm Hg at 20 degrees) and the low proposed use rate (0.2 lb ai/A). However, 

volatilization of pesticides may be a source of post-application inhalation exposure to individuals 

nearby pesticide applications. The Agency sought expert advice and input on issues related to 

volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act 

Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on 

March 2, 20103. The Agency is in the process of evaluating the SAP report and may, as

appropriate, develop policies and procedures to identify the need for and, subsequently, the way

to incorporate post-application inhalation exposure into the Agency's risk assessments. If new 

policies or procedures are developed, the Agency may revisit the need for a quantitative postapplication inhalation exposure assessment for pyraclostrobin.

6.6 Spray Drift

Spray drift is always a potential source of exposure to residents nearby to spraying operations. 

This is particularly the case with aerial application, but, to a lesser extent, could also be a 

potential source of exposure from the ground application method employed for pyraclostrobin. 

The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State 

Lead Agencies for pesticide regulation and other parties to develop the best spray drift 

management practices (see the Agency’s Spray Drift website for more information4). The 

Agency has completed its evaluation of the new database submitted by the Spray Drift Task 

Force, a membership of U.S. pesticide registrants, and is developing a policy on how to 

appropriately apply the data and the AgDRIFT computer model to its risk assessments for 

pesticides applied by air, orchard airblast and ground hydraulic methods. After the policy is in 

place, the Agency may impose further refinements in spray drift management practices to reduce 

off-target drift with specific products with significant risk estimates associated with drift.

 

3 Available: http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html

4 Available: http://www.epa.gov/opp00001/factsheets/spraydrift.htm 
Page 37 of 58

It is noted that the 0.5 lb ai/acre application rate for turf was modeled to estimate postapplication residential exposure of children. As this rate is equal to or higher than many of 

agricultural application rates, this scenario is protective of any exposure of farm children via 

spray drift from agricultural pyraclostrobin applications.

Although a quantitative residential post-application inhalation exposure assessment was not 

performed as a result of pesticide drift from neighboring treated agricultural fields, an inhalation 

exposure assessment was performed for flaggers. This exposure scenario is representative of a 

worse case inhalation (drift) exposure and may be considered protective of most outdoor 

agricultural and commercial post-application inhalation exposure scenarios. 

7.0 Aggregate Exposure/Risk Characterization

In accordance with 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 and risks from various sources, HED considers both the route and 

duration of exposure. For pyraclostrobin, potential exposures from food, drinking water, and 

residential scenarios were aggregated. 

7.1 Acute Aggregate Risk

The aggregate acute risk estimates include exposure to residues of pyraclostrobin in food and 

drinking water, and does not include dermal, inhalation, or incidental oral exposure. The acute 

risk estimate for the U.S. population and all other population subgroups, resulting from aggregate 

exposure to pyraclostrobin in food and drinking water, is not of concern. The food and drinking 

water exposure estimates are 1.5% of the aPAD for the U.S. general population, and 88% for the 

most highly exposed subgroup, females 13-49 years old.

7.2 Short-Term Aggregate Risk

There is potential short-term exposure to pyraclostrobin via dietary (which is considered 

background exposure) and residential (which is considered primary) exposure pathways. For 

adults, these pathways lead to exposure via oral (background) as well as dermal and inhalation 

(primary) routes. The most conservative scenarios were chosen for each population (e.g., handto-mouth exposure from treated turf for children 1-2 years old). For a description of the 

residential exposure scenarios considered in the aggregate assessment, see Section 6.4. 

The adult greatest exposure non-cancer aggregate MOE is 230 and is not of concern to HED. 

The aggregate MOE for children 1-2 years old, including incidental oral exposures from treated 

turf, is 120 and is not of concern to HED. 
Page 38 of 58

Table 7.2.1. Short-/Intermediate-Term Aggregate Risk Calculations 

Population Dermal Exposure Oral 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

Child 1-2 yrs 5 0.033 150 5.8 0.0048 0.009206 630 120

Child 6-11 yrs 5 0.01 490 5 NA 0.003525 1,400 360

Youth 11-16 yrs 5 0.0015 3,300 5 NA 0.001832 2,700 1,500

Adult Handler 5 0.004 1,300 5 NA 0.002707 1,800 760

Adult Post-application 5 0.019 260 5 NA 0.002707 1,800 230

1 The Level of Concern MOE is 100.

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

7.3 Intermediate-Term Aggregate Risk

Based on the registered residential uses of pyraclostrobin on residential and golf course turf, 

intermediate-term post application exposures are possible. However, since the short- and 

intermediate-term endpoints and PODs for dermal and oral routes are the same, the short-term 

exposure and risk estimates are considered to be protective of potential intermediate-term 

exposure and risk. 

7.4 Chronic Aggregate Risk

Chronic exposure from the residential pathway is not anticipated based on the current 

pyraclostrobin use pattern. The chronic aggregate risk (food and drinking water) is below HED’s 

LOC (i.e., <100% cPAD for the general U.S. population and all population subgroups). The 

dietary exposure is estimated at 0.002944 mg/kg/day for the general U.S. population (8.7% of the 

cPAD) and 0.009888 mg/kg/day (29% of the cPAD) for children 1-2 years old, the population 

subgroup with the highest estimated chronic dietary exposure to pyraclostrobin. See Section 

5.4.4 for details.

8.0 Cumulative Exposure/Risk Characterization

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 http://www.epa.gov/pesticides/cumulative/.
Page 39 of 58

9.0 Occupational Exposure/Risk Characterization

Pyraclostrobin is proposed for new occupational uses on sugarcane, globe artichoke, Belgium 

endive, persimmon, and greenhouse grown tomatoes. Application methods, maximum 

application rates, and use sites are summarized in Section 3.3 and Table 3.3. Based on the 

proposed use patterns, there is a potential for short- and intermediate-term occupational exposure 

to pyraclostrobin during handling (mixing, loading, and applying) and post-application activities. 

Pyraclostrobin uses are proposed for multiple applications, with the retreatment intervals ranging

from 7 to 28 days. The proposed labels require occupational handlers to wear the following 

personal protective equipment (PPE): long-sleeved shirts, long pants, chemical resistant gloves, 

and coveralls in a few cases. The 12 hour restricted entry interval (REI) listed on the labels is 

appropriate. 

9.1 Short-/Intermediate-Term Handler Risk

HED uses the term handlers to describe those individuals who are involved in the pesticide 

application process. HED believes that there are distinct job functions or tasks related to 

applications and exposures can vary depending on the specifics of each task. Job requirements 

(amount of chemical used in each application), the kinds of equipment used, the target being

treated, and the level of protection used by a handler can cause exposure levels to differ in a 

manner specific to each application event. 

Based on the anticipated use patterns from the proposed labels, types of equipment and 

techniques that can potentially be used, occupational handler exposure is expected from the 

proposed uses. HED’s LOC for the MOE is defined by the uncertainty factors that are applied to 

the assessment. HED applies a 10X factor to account for variability among species and a 10X 

factor to account for variability within species. The total uncertainty factor that has been applied 

to the non-cancer assessment of pyraclostrobin is 100X for occupational exposure. Occupational 

exposure and risk resulting in MOEs greater than or equal to 100 will not be of concern to HED. 

Dermal and inhalation exposure estimates were not combined in this assessment, since the 

toxicological PODs are based on different toxicological effects.

Summaries of the short- and intermediate-term non-cancer risk estimates for occupational 

handlers applying pyraclostrobin are provided in Appendix E, Tables E-1 and E-2. The dermal 

MOEs range from 47 (mixing/loading of SC formulation to support aerial applications to

sugarcane) to 7,800 (applying with aerial equipment to typical acreage crops) at baseline PPE. 

The proposed labels require occupational handlers to wear the following personal protective 

equipment (PPE): long-sleeved shirts, long pants, and chemical resistant gloves. All of the 

dermal MOEs are greater than the LOC of 100 when assessed using labeled PPE (gloves) and are 

not a concern to HED.

The inhalation MOEs range from 33 (mixing/loading of WDG formulation to support aerial and 

chemigation applications to artichoke and persimmon) to 8,500 (applying with manually

pressurized handwand equipment to greenhouse tomatoes) at baseline PPE (no respirator). The 

two inhalation scenarios with MOEs below 100 at baseline PPE [mixing/loading of WDG 
Page 40 of 58

formulation to support aerial and chemigation applications to artichoke and persimmon 

(MOE=33); and M/L/A of WDG formulation using a mechanically pressurized handgun to treat 

greenhouse tomatoes (MOE=85)] were no longer a concern to HED when assessed with a PF5 

respirator (MOEs >100). A PF5 respirator needs to be proposed on the affected Pristine 

Fungicide [EPA Reg. No.7969-199] and Pagent® Fungicide [EPA Reg. No.7969-251] labels.

9.2 Short-and Intermediate-Term Post-Application Risk

HED uses the term post-application to describe exposures that occur when individuals are 

present in an environment that has been previously treated with a pesticide (also referred to as reentry exposure). Such exposures may occur when workers enter previously treated areas to 

perform job functions, including activities related to crop production, such as scouting for pests 

or harvesting. Post-application exposure levels vary over time and depend on such things as the 

type of activity, the nature of the crop or target that was treated, the type of pesticide application, 

and the chemical’s degradation properties. In addition, the timing of pesticide applications, 

relative to harvest activities, can greatly reduce the potential for post-application exposure.

9.2.1 Dermal Post-Application Risk

Based on the proposed use patterns, short- and intermediate-term post-application dermal 

exposures to workers re-entering treated areas is possible. Therefore, a post-application risk 

assessment for dermal exposures is needed. It should be noted that there is no post-application 

dermal exposure anticipated for the proposed Belgium endive use, because the roots are treated 

with pyraclostrobin prior to forcing in the trays. Thus there would be negligible exposure to the 

residue when the crop is harvested or maintained.

Dislodgeable Foliar Residues

Chemical-specific DFR data was previously submitted by the registrant to support earlier registration 

requests for food crops. An overview of each study was provided in a previous assessment 

(D269670, K. O’Rourke, 9/30/2002). Pyraclostrobin DFR studies were conducted on peaches, 

peanuts, strawberries, and grapes. PMRA performed the primary review of these data, and 

considered the results useful for risk assessment purposes. It should be noted that PMRA used the 

DFR data only to calculate percent dissipation per day and half-lives. Therefore, HED went back to 

the initial study to calculate the DFR on day zero based on the results of the DFR study. The 

calculated DFR values on day zero were used in the post-application dermal assessments. The PA 

peach DFR data, which resulted in the highest DFR values of the three study sites, were used in the 

persimmon assessment. The CA strawberry DFR data, which also resulted in the highest DFR values 

of the three study sites, were used in the artichoke and greenhouse tomato assessments. The TX 

peanut DFR data, which resulted in the highest DFR values of the three study sites, were used in the 

sugarcane assessment. The peanut DFR data were selected for use in the sugarcane assessment 

because the climate of regions where both of these crops are grown is very similar. The DFR data 

used in this assessment are presented in Appendix F, Tables F-1 through F-3.

Occupational Post-application Non-Cancer Dermal Risk Estimates

The short- and intermediate-term non-cancer post-application risk estimates for workers are 

provided in Appendix E, Table E-3. All post-application scenarios resulted in MOEs greater 
Page 41 of 58

than 100 on day 0 (12 hours after application), and therefore, are not of concern to HED. The 

MOEs for pyraclostrobin ranged from 120 to 12,000.

Restricted Entry Interval

The REI specified on the proposed label is based on the acute toxicity of pyraclostrobin.

Pyraclostrobin is classified as Toxicity Category III via the dermal route and for skin and eye

irritation potential. It is not a skin sensitizer. Under 40 CFR 156.208 (c) (2) (iii), ai’s classified 

as Acute III or IV for acute dermal, eye irritation and primary skin irrigation are assigned a 12-

hour REI. Furthermore, the short- and intermediate-term post-application risk estimates were not 

a concern on day 0 (12 hours following application) for all post-application activities. Therefore, 

the [156 subpart K] Worker Protection Statement interim REI of 12 hours is adequate to protect 

agricultural workers from post-application exposures to pyraclostrobin.

9.2.2 Inhalation Post-Application Risk

Based on the Agency's current practices, a quantitative post-application inhalation exposure 

assessment was not performed for pyraclostrobin at this time primarily because of the low vapor 

pressure (1.9 x 10-8 mm Hg at 20 degrees C) and the low proposed use rate (0.2 lb ai/A). 

However, there are multiple potential sources of post-application inhalation exposure to 

individuals performing post-application activities in previously treated fields. These potential 

sources include volatilization of pesticides and resuspension of dusts and/or particulates that 

contain pesticides. The Agency sought expert advice and input on issues related to volatilization 

of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory

Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 20105. The 

Agency is in the process of evaluating the SAP report as well as available post-application 

inhalation exposure data generated by the ARTF and may, as appropriate, develop policies and 

procedures, to identify the need for and, subsequently, the way to incorporate occupational postapplication inhalation exposure into the Agency's risk assessments. If new policies or 

procedures are put into place, the Agency may revisit the need for a quantitative occupational 

post-application inhalation exposure assessment for pyraclostrobin.

Although a quantitative occupational post-application inhalation exposure assessment was not 

performed, an inhalation exposure assessment was performed for occupational/commercial 

handlers. Handler exposure resulting from application of pesticides outdoors is likely to result in 

higher exposure than post-application exposure. Therefore, it is expected that these handler 

inhalation exposure estimates would be protective of most occupational post-application 

inhalation exposure scenarios.

The Worker Protection Standard for Agricultural Pesticides contains requirements for protecting 

workers from inhalation exposures during and after greenhouse applications through the use of 

ventilation requirements [40 CFR 170.110, (3) (Restrictions associated with pesticide 

applications)].

 

5 Available: http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html
Page 42 of 58

10.0 References

S. Funk, 4/30/13, DP403449. Pyraclostrobin: Request for the Use on Sugarcane. Summary of 

Analytical Chemistry and Residue Data.

S. Funk, 4/30/13, DP398877. Boscalid and Pyraclostrobin: Application by Bonide Products, 

Inc. to Register an End Use Product Containing Pyraclostrobin, Boscalid, and Lambda 

Cyhalothrin for Homeowner Use on Pome Fruit, Stone Fruit, and Tree Nuts. 

S. Funk, 4/30/13, DP406471. Pyraclostrobin and Boscalid: Request to Add Indoor Use on 

Greenhouse Tomato for Commercial Production and on Greenhouse/Lathhouse Transplants for 

Consumer Home Market. PagentTM Fungicide Reg. No. 7969-251.

S. Funk, 6/24/13, DP410737. Amended: Pyraclostrobin: Petition for the Establishment of 

Permanent Tolerances and Registration for Use on Belgium Endive, Persimmon, and Globe 

Artichoke. Request for Crop Group Expansions/Revisions for Bulb Vegetable Group 3-07, 

Fruiting Vegetable 8-10, Citrus Fruit Group 10-10, Pome Fruit Group 11-10, Berry Subgroups 

13-07A, B, F, and G, and Oilseed Group 20. Summary of Analytical Chemistry and Residue 

Data

S. Funk, 4/30/13, DP410739. Pyraclostrobin. Acute and Chronic Aggregate Dietary (Food and 

Drinking Water) Exposure and Risk Assessments to Support New Uses on Sugarcane, 

Persimmon, Globe Artichoke, and Belgium Endive.

C. Walls, 4/30/13, DP403449. Pyraclostrobin. Occupational and Residential Exposure 

Assessment for proposed new uses of pyraclostrobin on sugarcane, globe artichoke, Belgium 

endive, persimmon, greenhouse grown tomato transplants grown for home consumer market, and 

residential ornamentals, landscape gardens, fruit trees and nut trees.

F. Khan, 4/4/13, DP403871. Addendum of Drinking Water Exposure Assessment for the 

Section 3 New Uses of Pyraclostrobin on Various Agricultural Crops and Residential 

Ornamentals.

S. Haddad, 11/18/2012, SIAB/BEAD, Screening Level Estimates of Agricultural Uses (SLUA) 

for the Fungicide Pyraclostrobin (099100)
Page 43 of 58

Appendix A. Toxicology Profile and Executive Summaries

A.1 Toxicology Data Requirements

The requirements (40 CFR 158.500) for food uses are in the table below. Use of the new 

guideline numbers does not imply that the new (1998) guideline protocols were used.

Table A.1: Toxicology Studies Required Submitted Satisfied

870.1100 Acute Oral Toxicity ................................................................................................

870.1200 Acute Dermal Toxicity...............................................................................................

870.1300 Acute Inhalation Toxicity ..........................................................................................

870.2400 Acute Eye Irritation................................................................................................

870.2500 Acute Dermal Irritation..............................................................................................

870.2600 Skin Sensitization................................................................................................

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

870.3100 90-Day Oral Toxicity in Rodents................................................................

870.3150 90-Day Oral Toxicity in Non-Rodents................................................................

870.3200 21/28-Day Dermal Toxicity .......................................................................................

870.3250 90-Day Dermal Toxicity ............................................................................................

870.3465 90-Day Inhalation Toxicity........................................................................................

yes

yes

yes

no (CR)

yes (CR)

yes

yes

yes

no

yes

yes

yes

yes

---

yes

870.3700 Prenatal Developmental Toxicity Study (Rodent)......................................................

870.3700 Prenatal Developmental Toxicity Study (Non-Rodent)................................

870.3800 Reproduction and Fertility Effects................................................................

yes

yes

yes

yes

yes

yes

yes

yes

yes

870.4100 Chronic Toxicity (Rodent).........................................................................................

870.4100 Chronic Toxicity (Non-Rodent).................................................................................

870.4200 Carcinogenicity (Two Rodent Species; Rat and Mouse)................................

870.4300 Combined Chronic Toxicity/Carcinogenicity ............................................................

yes

no

yes

no

yes

yes

yes

no

yes

---

yes

yes

870.5100 Bacterial Reverse Mutation Test................................................................................

870.5300 in vitro Mammalian Cell Gene Mutation Test............................................................

870.5375 in vitro Mammalian Chromosome Aberration Test....................................................

870.5385 Mammalian Bone Marrow Chromosomal Aberration Test................................

870.5395 Mammalian Erythrocyte Micronucleus Test ..............................................................

870.5550 Unscheduled DNA Synthesis in Mammalian Cells in Culture................................

yes

yes

yes

---

yes

no

yes

yes

yes

no

yes

yes

yes

yes

yes

---

yes

---

870.6100 Delayed Neurotoxicity of Organophosphorus Substances (Acute, Hen)....................

870.6100 Delayed Neurotoxicity of Organophosphorus Substances (28-Day, Hen) .................

870.6200 Neurotoxicity Screening Battery (Acute, Rat) ...........................................................

870.6200 Neurotoxicity Screening Battery (Subchronic, Rat)...................................................

870.6300 Developmental Neurotoxicity Study ................................................................

no (CR)

no (CR)

yes

yes

no (CR)

no

no

yes

yes

no

---

---

yes

yes

---

870.7200 Companion Animal Safety.........................................................................................

870.7485 Metabolism and Pharmacokinetics................................................................

870.7600 Dermal Penetration ................................................................................................

in vitro Dermal Penetration........................................................................................

870.7800 Immunotoxicity................................................................................................

no (CR)

yes

no (CR)

no

yes

no

yes

yes

no

yes

---

yes

---

---

---

CR: Conditionally Required

A.2 Toxicity Profiles

Table A.2.1. Acute Toxicity of Pyraclostrobin

Table A.2.1: Acute Toxicity Profile

Guideline Study Type MRID Results

Toxicity

Category

870.1100 Acute Oral Toxicity 45118302 LD50 ≥ 5000 mg/kg IV

870.1200 Acute Dermal Toxicity 45118305 LD50 >2000 mg/kg III

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

870.2400 Acute Eye Irritation 45118311

Minimal Eye Irritation

Maximum Average Score (MAS): 4.6 / 110

24 hr Maximum Irritation Score (MIS): 6.3 / 110

III
Page 44 of 58

Table A.2.1: Acute Toxicity Profile

Guideline Study Type MRID Results

Toxicity

Category

870.2500 Acute Dermal Irritation 45118314

Moderate Skin Irritation

Maximum Average Score (MAS): 2.2 / 8.0

24 h Maximum Irritation Score (MIS): 2.7 / 8.0

III

870.2600 Dermal Sensitization 45118317 Not a dermal sensitizer N/A

Table A.2.2. Non-acute Toxicity Profile for Pyraclostrobin

Table A.2.2. Subchronic, Chronic, and Other Toxicity Profiles

Guideline Study Type MRID (year) / Doses / Classification Results

870.3050 Repeated Dose 

28-Day Oral Toxicity 

in Rodents (Rat)

45118322 (1999)

Dietary Concentration (ppm):

0, 20, 100, 500, 1500

Intake Dose (mg/kg/day):

M: 0, 1.8, 9.0, 42.3, 120.2

F: 0, 2.0, 9.6, 46.6, 126.3

Acceptable / Guideline

NOAEL (mg/kg/day): M = 9.0 F = 9.6

LOAEL (mg/kg/day): M = 42.3 F = 46.6

Based on changes in hematology parameters, increased 

spleen weight (both absolute and relative), and 

histopathology in the spleen and liver, in addition to 

increased duodenal mucosal hyperplasia.

870.3100 90-Day Oral Toxicity 

in Rodents (Rat)

45118321 (1999)

45118322 (1999) – Dose Selection

Dietary Concentration (ppm):

0, 50, 150, 500, 1000 1500

Intake Dose (mg/kg/day):

M: 0, 3.5, 10.7, 34.7, 68.8, 105.8

F: 0, 4.2, 12.6, 40.8, 79.7, 118.9

Acceptable / Guideline

NOAEL (mg/kg/day): M = 10.7 F = 12.6

LOAEL (mg/kg/day): M = 34.7 F = 40.8

Based on decreased body weights/body weight gains 

(males), decreased food consumption, increased relative 

liver weight and absolute and relative spleen weight in 

females, and histopathology of the duodenum, spleen 

and liver.

90-Day Oral Toxicity 

in Rodents (Mouse)

45118320 (1999)

Dietary Concentration (ppm):

0, 50, 150, 500, 1000 1500

Intake Dose (mg/kg/day):

M: 0, 9.2, 30.4, 119.4, 274.4, 475.5

F: 0, 12.9, 40.4, 162.0, 374.1, 634.8

Acceptable / Guideline

NOAEL (mg/kg/day): M = 9.2 F = 12.9

LOAEL (mg/kg/day): M = 30.4 F = 40.4

Based on decreased body weights/body weight gains 

(males), changes in clinical chemistry (increased urea 

and decreased triglycerides), and increased incidences in 

females of lymph node apoptosis, thymus atropy, and 

ulcer/erosion in the glandular stomach.

870.3150 90-Day Oral Toxicity 

in Non-Rodents (Dog)

45118323 (1999) 

Dietary Concentration (ppm):

0, 100, 200, 450

Intake Dose (mg/kg/day):

M: 0, 2.8, 5.8, 12.9

F: 0, 3.0, 6.2, 13.6

Acceptable / Guideline

NOAEL (mg/kg/day): M = 5.8 F = 6.2

LOAEL (mg/kg/day): M = 12.9 F = 13.6

Based on an increased incidence of diarrhea, clinical 

chemistry changes and mucosal hypertrophy of the 

duodenum (both sexes) and body weight loss, decreased 

food intake and decreased food efficiency (females 

only).

870.3200 21/28-Day

Dermal Toxicity 

(Rabbit)

45118324 (1999)

Applied Dose (mg/kg/day):

M: 0, 40, 100, 250

F: 0, 40, 100, 250

Unacceptable / Guideline

Unacceptable due to the lack of systemic 

effects at the highest dose tested (250 

mg/kg/day); the limit dose is 1000 

mg/kg/day.

Dermal

NOAEL (mg/kg/day): M = 40 F = 40

LOAEL (mg/kg/day): M = 100 F = 100

Based on scale formation, hyperkeratosis, and epidermal 

thickening at the site of application.

Systemic

NOAEL (mg/kg/day): M = 250 F = 250

LOAEL (mg/kg/day): M > 250 F > 250
Page 45 of 58

Table A.2.2. Subchronic, Chronic, and Other Toxicity Profiles

Guideline Study Type MRID (year) / Doses / Classification Results

870.3465 28-Day 

Inhalation Toxicity

(Rat)

46638801 (2005)

Applied Dose (mg/L):

M: 0, 0.001, 0.030, 0.300

F: 0, 0.001, 0.030, 0.300

Acceptable / Guideline

NOAEL (mg/L): M = 0.001 F = 0.001

LOAEL (mg/L): M = 0.030 F = 0.030

Based on findings of hyperplasia in the duodenum, 

alveolar histiocytosis in the lungs, and olfactory 

atrophy/necrosis in the nasal tissues.

870.3700 Prenatal 

Developmental 

Toxicity Study (Rat)

45118325 (1999) 

Gavage Dose (mg/kg/day):

F: 0, 10, 25, 50

Acceptable / Guideline

Maternal

NOAEL (mg/kg/day) = 10

LOAEL (mg/kg/day) = 25

Based on decreased body weights and body weight gains 

and reduced food consumption and reduced food 

efficiency.

Developmental

NOAEL (mg/kg/day) = 25

LOAEL (mg/kg/day) = 50

Based on increased incidence of dilated renal pelvis and 

cervical ribs.

Prenatal 

Developmental 

Toxicity Study 

(Rabbit)

45118326 (1999)

45437001 (2001)

Gavage Dose (mg/kg/day):

F: 0, 1, 3, 5, 10, 20

Acceptable / Guideline

Maternal

NOAEL (mg/kg/day) = 5

LOAEL (mg/kg/day) = 10

Based on body weight gains, reduced food consumption 

and reduced food efficiency.

Developmental

NOAEL (mg/kg/day) = 5

LOAEL (mg/kg/day) = 10

Based on increased resorptions per litter, increased postimplantation loss and dams with total resorptions.

870.3800 Reproduction and 

Fertility Effects 

(Rat)

45118327 (1999) 

Dietary Concentration (ppm):

0, 25, 75, 300

Intake Dose (mg/kg/day):

M0: 0, 2.5, 7.4, 29.0

F0: 0, 2.6, 7.8, 30.4

M1: 0, 2.8, 8.6, 35.0

F1: 0, 3.0, 9.0, 36.0

Acceptable / Guideline

Parental

NOAEL (mg/kg/day): M = 29.0 F = 30.4

LOAEL (mg/kg/day): M > 29.0 F > 30.4

Reproductive

NOAEL (mg/kg/day): M = 29.0 F = 30.4

LOAEL (mg/kg/day): M > 29.0 F > 30.4

Offspring

NOAEL (mg/kg/day): M = 29.0 F = 30.4

LOAEL (mg/kg/day): M > 29.0 F > 30.4

45596210 (2002) 

Dietary Concentration (ppm):

0, 200, 400, 600

Intake Dose (mg/kg/day):

M: 0, 20.5, 39.9, 59.1

F: 0, 21.3, 42.5, 60.4

Acceptable / Non-Guideline

One-Generation Study

Parental

NOAEL (mg/kg/day): M = 20.5 F = 42.5

LOAEL (mg/kg/day): M = 39.9 F = 60.4

Based on reduced body weights and body weight gains.

Reproductive

NOAEL (mg/kg/day): M < 20.5 F < 21.3

LOAEL (mg/kg/day): M ≤ 20.5 F ≤ 21.3

Offspring

NOAEL (mg/kg/day): M ≥ 59.1 F ≥ 60.4

LOAEL (mg/kg/day): M > 59.1 F > 60.4

Based on a reduced pup body weights and body weight 

gains (a threshold body weight effect).
Page 46 of 58

Table A.2.2. Subchronic, Chronic, and Other Toxicity Profiles

Guideline Study Type MRID (year) / Doses / Classification Results

870.4100 Chronic Toxicity 

(Rat)

45118329 (1999)

Dietary Concentration (ppm):

0, 25, 75, 200

Intake Dose (mg/kg/day):

M: 0, 1.1, 3.4, 9.0

F: 0, 1.5, 4.6, 12.3

Unacceptable / Guideline

Unacceptable due to low dose selection

NOAEL (mg/kg/day): M = 9.0 F = 12.3

LOAEL (mg/kg/day): M > 9.0 F > 12.3

There was no evidence of carcinogenic potential

Chronic Toxicity 

(Dog)

45118328 (1999)

Dietary Concentration (ppm):

0, 100, 200, 400

Intake Dose (mg/kg/day):

M: 0, 2.7, 5.4, 10.8

F: 0, 2.7, 5.4, 11.2

Acceptable / Guideline

NOAEL (mg/kg/day): M = 5.4 F = 5.4

LOAEL (mg/kg/day): M = 10.8 F = 11.2

Based on an increased incidence of diarrhea and clinical 

chemistry changes (both sexes) and decreased body 

weight gain, decreased food intake and decreased food 

efficiency (females only).

870.4200 Carcinogenicity (Rat) 45118331 (1999)

Dietary Concentration (ppm):

0, 25, 75, 200

Intake Dose (mg/kg/day):

M: 0, 1.2, 3.4, 9.2

F: 0, 1.5, 4.7, 12.6

Acceptable / Guideline

NOAEL (mg/kg/day): M = 3.4 F = 4.7

LOAEL (mg/kg/day): M = 9.2 F = 12.6

Based on differences in body weight and body weight 

gains, increased incidences of kidney tubular casts and 

atrophy in males and females, and in males, an increased 

incidence of necrosis of the liver, gross and microscopic 

evidence of erosion/ulcer of the glandular stomach and 

an increased incidence of acanthosis and ulcers of the 

forestomach.

Under the conditions of this study, there was no 

evidence of carcinogenic potential.

Carcinogenicity 

(Mouse)

45118330 (1999)

Dietary Concentration (ppm):

M: 0, 10, 30, 120

F: 0, 10, 30, 120, 180

Intake Dose (mg/kg/day):

M: 0, 1.4, 4.1, 17.2

F: 0, 1.6, 4.8, 20.5, 32.8

Unacceptable / Guideline

Unacceptable due to low dose selection

NOAEL (mg/kg/day): M ≥ 17.2 F ≥ 32.8

LOAEL (mg/kg/day): M > 17.2 F > 32.8

Under the conditions of this study, there was no 

evidence of carcinogenic potential.

870.5100 Bacterial Reverse 

Mutation Test

(Salmonella 

typhimurium)

45118332 (1997)

Applied Dose (μg/plate):

S9: 0, 20, 100, 500, 2500,

5000

Acceptable / Guideline

±S9: Negative up to 2500 μg/plate in the absence of 

cytotoxicity with precipitation above this concentration.

There was no evidence of treatment-induced mutant 

colonies above background levels.

870.5300 in vitro Mammalian 

Cell Gene Mutation 

Test

(Mouse Lymphoma 

Cells)

45118335 (1998)

Applied Dose (μg/mL):

S9: 0.625, 1.25, 2.5, 5.0, 10.0,

20.0

S9: 3, 4, 5, 6, 7,

8

S9: 1.25, 2.5, 5.0, 10.0, 20.0

Acceptable / Guideline

BAS 500 F was tested up to cytotoxic and solubility 

limit concentrations. The positive controls induced the 

appropriate response. There was no evidence of induced 

mutant colonies over background.
Page 47 of 58

Table A.2.2. Subchronic, Chronic, and Other Toxicity Profiles

Guideline Study Type MRID (year) / Doses / Classification Results

870.5375 in vitro Mammalian 

Chromosome 

Aberration Test

(Chinese Hamster 

Ovary cells)

45118333 (1999)

Applied Dose (μg/mL):

S9: 0, 6.25, 12.5, 25.0

+S9: 0, 3.125, 6.25, 12.5

S9: 0, 0.005, 0.010, 0.050, 0.100

Acceptable / Guideline

BAS 500 F was tested up to preciptating concentrations.

Positive controls induced the appropriate response.

There was no evidence of an increase in the number of

structural or numerical chromosomal aberrations 

induced over background. It is therefore concluded that 

BAS 500 F is not a clastogenic agent under the 

conditions of this study.

870.5395 Mammalian 

Erythrocyte 

Micronucleus Test

(Mouse)

45118334 (1998)

Gavage Dose (mg/kg/day):

M: 0, 75, 150, 300

F: 0, 75, 150, 300

Acceptable / Guideline

There was no significant increase in the frequency of 

micronucleated polychromatic erythrocytes in bone 

marrow at any dose level tested, at any time after

treatment. It is therefore concluded that BAS 500 F did 

not induce a clastogenic effect in either sex at any 

sacrifice time.

870.5550 Unscheduled DNA 

Synthesis in 

Mammalian Cells in 

Culture

(Rat Hepatocytes)

45118336 (1998)

Applied Dose (μg/mL):

Run 1: 0.01, 0.03, 0.1, 0.3, 1.0

Run 2: 0.004, 0.02, 0.5

Acceptable / Guideline

BAS 500 F was tested up to cytotoxic concentrations.

The positive controls induced the appropriate response.

There was no evidence that BAS 500 F induced 

unscheduled DNA synthesis, as determined by net 

nuclear silver grain counts.

870.6200 Acute Neurotoxicity 

Screening Battery

(Rat)

45118337 (1999)

Gavage Dose (mg/kg/day):

M: 0, 100, 300, 1000

F: 0, 100, 300, 1000

Acceptable / Guideline

Neurotoxicity

NOAEL (mg/kg/day): M = 1000 F = 1000

LOAEL (mg/kg/day): M > 1000 F > 1000

Systemic

NOAEL (mg/kg/day): M = 300 F = 1000

LOAEL (mg/kg/day): M = 1000 F > 1000

For males, based on 33% decreased body weight gain (p 

 0.01) on days 0-7; no similar effect was detected on 

days 0-14.

90-Day Neurotoxicity 

Screening Battery

(Rat)

45118401 (1999)

Dietary Concentration (ppm):

0, 50, 250, M: 750

F: 1500

Intake Dose (mg/kg/day):

M: 0, 3.5, 16.9, 49.9

F: 0, 4.0, 20.4, 111.9

Acceptable / Guideline

Neurotoxicity

NOAEL (mg/kg/day): M = 49.9 F = 111.9

LOAEL (mg/kg/day): M > 49.9 F > 111.9

Systemic

NOAEL (mg/kg/day): M = 16.9 F = 20.4

LOAEL (mg/kg/day): M = 49.9 F = 111.9

Based on decreased body weight gain, food intake and 

food efficiency (both sexes) and decreased water intake 

(males only).
Page 48 of 58

Table A.2.2. Subchronic, Chronic, and Other Toxicity Profiles

Guideline Study Type MRID (year) / Doses / Classification Results

870.7485 Metabolism and 

Pharmacokinetics 

(Rat)

45118403 (1998)

45118404 (1999)

Gavage Dose (mg/kg):

Single: 5, 50

Repeated: 50

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 halflife 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.
Page 49 of 58

Table A.2.2. Subchronic, Chronic, and Other Toxicity Profiles

Guideline Study Type MRID (year) / Doses / Classification Results

870.7600 Dermal Penetration 

(Rat)

45118402 (1999)

Applied Dose (mg/cm2):

M: 0.015, 0.075, 0.375

Unacceptable / Guideline

Unacceptable because the actual dose was 

indeterminate due to material retained on 

the dressings being unavailable for 

absorption. 

The HIARC calculated and recommended a dermal 

penetration rate of 14%. (TXR#0051553: 10 FEB 2003)

In all three doses the largest portion of the dose was 

found in the Dressings (72.38-84.36%, 78.51-81.58% 

and 76.38-80.24% for the respective doses) The 

dressings consisted of silicone ring, nylon mesh cover 

and porous bandage. This material must be considered 

unavailable for absorption.

Dermal penetration of [14C-tolyl]-pyraclostrobin was 

low for all dose groups and time intervals (0.44-2.60%).

After an 8-hour exposure period, absorbed radioactivity 

accounted for 0.65%, 0.86% and 0.50% of the applied 

dose at nominal doses of 0.015, 0.075 and 0.375 

mg/cm2, respectively. After removal of the test 

substance and washing the site, absorption continued -

an additional 0.93-1.74% of the dose in each dose group 

over the next 64 hours; however, there was no 

concomitant decrease in radioactivity in the skin.

The percent of the dose absorbed was not dose 

dependent; however, the actual amount of the test 

material absorbed did increase with increasing dose 

level. Immediately following the 8-hour exposure 

period, absorbed radioactivity accounted for 0.105, 

0.757 and 2.27 μg/cm2at mean achieved doses of 0.017, 

0.087 and 0.428 mg/cm2. Comparing the increases from 

the low to high-dose groups, the amount of actual 

absorption increased by 21.6x compared to the 25.2x 

increase in the dose level. This pattern of absorption is 

commonly seen with a chemical which directly damages 

the stratum corneum of the skin.

870.7800 Immunotoxicity

(Mouse)

48830601 (1999)

Dietary Concentration (ppm):

0, 50, 200, 750

Intake Dose (mg/kg/day):

F: 0, 13, 50, 165

Unclassified

Preliminary review of the studies does not indicate any 

immunotoxicity or systemic toxicity below 165 

mg/kg/day.

48830602 (2012)

Dietary Concentration (ppm):

0, 50, 200, 750

Intake Dose (mg/kg/day):

F: 0, 13, 50, 202

Unclassified

48830603 (2012)

Dietary Concentration (ppm):

0, 50, 200, 750

Intake Dose (mg/kg/day):

F: 0, 14, 55, 191

Unclassified
Page 50 of 58

Appendix B. Physicochemical Properties of Pyraclostrobin.

TABLE B. Physicochemical Properties of Technical Grade Pyraclostrobin.

Parameter Value References1 (MRID)

Melting point/range 63.7-65.2oC 45118213

pH Not applicable

Density 1.367 g/cm345118214

Water solubility at 20 oC 1.9 ± 0.17 mg/L (deionized water, pH 5.8) 45118233

Solvent solubility n-heptane (0.37 g/100mL); 2-propanol (3.0 

g/100mL); 1-octanol (2.42 g/100mL); olive oil 

(2.80 g/100m/L); methanol (10.08 g/100mL); 

>50 g/100mL in acetone, ethyl acetate , 

acetonitrile, dichloromethane and toluene.

45118228

Vapor pressure 2.6 x 10-10 hPa at 20 oC 45118214

Dissociation constant, pKa None (no dissociable moieties)

Octanol/water partition coefficient, 

Log(KOW) at room temperature

3.990 mean log Pow; Pow is 9772 45118215

UV/visible absorption spectrum The structural identity of BAS 500 F was 

confirmed by NMR and MS spectra. UV 

molecular extinction (e [1 mol-1cm-1]): 2.5x104

at 205 nm; 2.4x104at 275 nm.

1996/109552

1

Product Chemistry data were reviewed by the Registration Division (DP# 269848 and DP# 274191, 5/3/01, 5/15/01, and 

6/7/01, S. Malak). 

2 BASF Document Number.

Appendix C. Review of Human Research

The PHED Task Force, 1995. The Pesticide Handlers Exposure Database, Version 1.1. 

Electronic Database. Task Force Members: Health Canada, U.S. EPA, and the National 

Agricultural Chemicals Associations, released February 1995. 

The Agricultural Handler Exposure Task Force (AHETF), 2011. The Occupational Handler Unit 

Exposure Surrogate Reference Table. U.S. EPA. Released June 21, 2011. 

Data from the Outdoor Residential Exposure Task Force (ORETF). 

HED Residential Standard Operating Procedures (2012). 
Page 51 of 58

Appendix D. Summaries of Field Residue Data

TABLE D-1. Summary of Residue Data from Crop Field Trials with Pyraclostrobin on Sugarcane.

Commodity Total 

Applic. Rate

(lb ai/A)

[kg ai/ha]

PHI 

(days)

Analyte Residue Levels1

(ppm)

n Sample

Min.

Sample

Max.

LAFT2 HAFT2 Median Mean Std. 

Dev.

Sugarcane 0.78-0.81

(0.88-0.91)

13-14

Pyraclostrobin 8 <0.02 0.1049 <0.02 0.099 0.058 <0.060 0.026

BF 500-3 8 <0.02 0.0267 <0.02 0.027 <0.02 <0.021 0.002

Combined 8 <0.04 <0.125 <0.040 <0.119 <0.076 <0.076 0.029

27-28

Pyraclostrobin 8 <0.02 0.0866 <0.020 0.068 0.043 <0.044 0.016

BF 500-3 8 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 N/A

Combined 8 <0.04 <0.1066 <0.040 <0.088 <0.062 <0.061 0.017

Sugarcane

(for 

processing)

3.94-3.99

[4.42-4.47]

14

Pyraclostrobin 2 0.0238 0.2935 0.028 0.255 0.141 0.141 N/A

BF 500-3 2 <0.02 0.0253 <0.02 0.025 <0.022 <0.022 N/A

Combined 2 <0.044 0.319 <0.048 0.280 <0.164 <0.164 N/A

28

Pyraclostrobin 2 0.0203 0.381130.026 0.268 0.147 0.147 N/A

BF 500-3 2 <0.02 0.0405 <0.02 <0.030 <0.025 <0.025 N/A

Combined 2 <0.040 0.422 <0.046 <0.299 <0.172 <0.172 N/A

TABLE D-2. Summary of Residue Data from Globe Artichoke Crop Field Trials with Pyraclostrobin.

Commodity Total Applic. 

Rate

(lb ai/A)

[kg ai/ha]

PHI 

(days)

Analyte Residue Levels1

(ppm)

n

Sample

Min.

Sample

Max.

LAFT2 HAFT2 Median Mean Std. 

Dev.

Artichoke 

Flower Head

0.549-0.562

(0.615-0.630) 0

Pyraclostrobin 3 0.514 1.110 0.618 1.045 0.759 0.807 0.218

BF 500-3 3 <0.02 0.056 <0.02 0.056 <0.028 <0.035 0.019

Combined 3 <0.534 1.166 <0.638 1.101 <0.787 <0.842 0.236

1

 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For calculation of median, mean, and 

standard deviation, the LLMV (0.02 ppm) was used for any results reported as <LLMV in Table C.3.

2

 LAFT = lowest average field trial; HAFT = highest average field trial.
Page 52 of 58

TABLE D-3. Summary of Residue Data from Belgium Endive Crop Field Trials with Pyraclostrobin.

Commodity Rate1 PHI 

(days) Analyte

Residue Levels2

(ppm)

n

Sample

Min.

Sample

Max. LAFT3 HAFT3 Median Mean Std. Dev.

Treatment 02: One pre-cold-storage application to roots

Belgium

endive heads

0.578-0.597 g 

ai/100 lb of 

roots

25-27

Pyraclostrobin 3 <0.02 0.0679 <0.023 0.059 <0.040 <0.041 0.018

BF 500-3 3 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 N/A

Combined 3 <0.04 <0.088 <0.043 <0.079 <0.06 <0.061 0.018

Treatment 03: One pre-forcing application to roots in packing tray

Belgium

endive heads

0.089-0.097 g 

ai/ft2 17-19

Pyraclostrobin 3 0.1239 1.7620 0.150 1.347 0.900 0.799 0.605

BF 500-3 3 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 N/A

Combined 3 <0.144 <1.782 <0.170 <1.367 <0.920 0.819 0.605

Treatment 04: One pre-cold-storage application to roots + One pre-forcing application to roots in packing tray

Belgium

endive heads

0.584-0.591 g 

ai/100 lb of 

roots and3

0.092-0.101 g 

ai/ft2

17-19

Pyraclostrobin 3 0.2250 0.8710 0.256 0.771 0.551 0.526 0.258

BF 500-3 3 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 N/A

Combined 3 <0.245 <0.891 <0.276 <0.791 <0.571 <0.546 0.258

1

 Rate for pyraclostrobin, as calculated by the study reviewer based on the certificate of analysis of applied product in the study 

report.

2

 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For calculation of median, mean, and 

standard deviation, the LLMV (0.02 ppm) was used for any results reported as <LLMV in Table C.3. N/A = Not Applicable.

3

 LAFT = lowest average field trial; HAFT = highest average field trial.

TABLE D-4. Summary of Residue Data from Persimmon Crop Field Trials with Pyraclostrobin.

Commodity Total Applic. 

Rate

(lb ai/A)

[kg ai/ha]

PHI 

(days)

Analyte Residue Levels1

(ppm)

n

Sample

Min.

Sample

Max.

LAFT2 HAFT2 Median Mean Std. 

Dev.

Persimmon 

Fruit

0.564-0.573

(0.632-0.642)

0

Pyraclostrobin 3 0.421 1.278 0.092 1.155 0.437 0.561 0.542

BF 500-3 3 <0.02 0.077 <0.02 0.073 <0.02 <0.038 0.031

Combined 3 <0.103 1.355 <0.112 1.228 <0.457 <0.599 0.571

1

 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For calculation of median, mean, and 

standard deviation, the LLMV (0.02 ppm) was used for any results reported as <LLMV in Table C.3. N/A = Not Applicable.

2

 LAFT = lowest average field trial; HAFT = highest average field trial.
Page 53 of 58

Appendix E. Summaries of Occupational Handler and Post-application Exposure and Risk Estimates

Table E-1. Occupational Handler Non-Cancer Exposure and Risk Estimates for Pyraclostrobin.

Exposure Scenario Crop

Dermal Unit 

Exposure (μg/lb ai)1

Inhalation Unit 

Exposure (μg/lb ai)1 Maximum

Application 

Rate2

(lb ai/A)

Area 

Treated or 

Amount 

Handled 

Daily3

Dermal Inhalation

Baseline Baseline Dose 

(mg/kg/day)4 MOE5 Dose (mg/kg/day)6 MOE7

Mixer/Loader

Aerial applications of 

WDG

and

Chemigation application of 

WDG

Artichoke

Persimmon 227 8.96 0.18 350 0.029 170 0.0071 33

Aerial applications of

SC

Sugarcane 220 0.219 0.20 1200 0.11 47 0.00069 350

Airblast application of 

WDG Persimmon 227 8.96 0.18 40 0.0033 1,500 0.00081 290

Chemigation application of 

WDG

and

Groundboom application 

of WDG

Greenhouse 

tomatoes 227 8.96 0.18 60 0.0050 1,000 0.0012 190

Chemigation applications 

of SC Sugarcane 220 0.219 0.20 350 0.031 160 0.00019 1,200

Groundboom application 

of WDG Artichoke 227 8.96 0.18 80 0.0066 750 0.0016 140

Groundboom application 

of SC Sugarcane 220 0.219 0.20 200 0.018 280 0.00011 2,100

Applicator

Aerial application Artichoke

Persimmon 5 0.068 0.18 350 0.00064 7,800 0.000054 4,300

Aerial application Sugarcane 5 0.068 0.20 1200 0.0024 2,100 0.00020 1,100

Airblast application Persimmon 1770 4.71 0.18 40 0.026 190 0.00042 540

Groundboom application Greenhouse 78.6 0.34 0.18 60 0.0017 2,900 0.000046 5,000
Page 54 of 58

Table E-1. Occupational Handler Non-Cancer Exposure and Risk Estimates for Pyraclostrobin.

Exposure Scenario Crop

Dermal Unit 

Exposure (μg/lb ai)1

Inhalation Unit 

Exposure (μg/lb ai)1 Maximum

Application 

Rate2

(lb ai/A)

Area 

Treated or 

Amount 

Handled 

Daily3

Dermal Inhalation

Baseline Baseline Dose 

(mg/kg/day)4 MOE5 Dose (mg/kg/day)6 MOE7

tomatoes

Groundboom application Artichoke 78.6 0.34 0.18 80 0.0023 2,200 0.000071 3,200

Groundboom application Sugarcane 78.6 0.34 0.20 200 0.0064 780 0.00017 1,400

Flagger

Flagger Artichoke

Persimmon 11 0.35 0.18 350 0.0014 3,500 0.00028 830

Flagger Sugarcane 11 0.35 0.20 350 0.0016 3,200 0.00031 750

Mixer/Loader/Applicator

Backpack application of 

WDG

Greenhouse 

tomatoes 13,200 140 0.0018

lb ai/gal

40

gal 0.0019 2,600 0.00013 1,800

Manually pressurized 

handwand app of WDG

Greenhouse 

tomatoes 100,000 30 0.0018

lb ai/gal

40

gal 0.015 340 0.000027 8,500

Mechanically pressurized 

handgun of WDG

Artichoke

Persimmon 1300 3.9 0.0018lb ai/gal

1000

gal 0.0048 1,100 0.00088 2,600

Mechanically pressurized 

handgun of WDG

Greenhouse 

tomatoes 3500 120 0.0018

lb ai/gal

1000

gal 0.013 390 0.0027 85

Mechanically pressurized 

handgun of WDG

Belgium 

Endive – prior 

to cold storage

1300 3.9

0.000014 

lb ai/ lb root

200,000

lb root 0.0074 680 0.00014 1,700

Mechanically pressurized 

handgun of WDG

Belgium 

Endive – prior 

to forcing

1300 3.9 0.0002

lb ai/ft2

10,890

ft2 0.0057 870 0.00011 2,200

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” (March 2013); 

2 Based on proposed label (See Table 4).

3 Exposure Science Advisory Council Policy #9.1.

4 Dermal Dose = Dermal Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled Daily (A or gal/day) × DAF (%) ÷ BW 

(kg).

5 Dermal MOE = Dermal NOAEL (mg/kg/day) ÷ Dermal Dose (mg/kg/day).

6 Inhalation Dose = Dermal Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled Daily (A or gal/day) ÷ BW (kg).

7 Inhalation MOE = Inhalation NOAEL (mg/kg/day) ÷ Inhalation Dose (mg/kg/day).
Page 55 of 58

Table E-2. Occupational Handler Non-Cancer Exposure and Risk Estimates for Pyraclostrobin with PPE.

Exposure Scenario Crop

Dermal Unit 

Exposure (μg/lb ai)1

Inhalation Unit 

Exposure (μg/lb ai)1 Maximum

Application 

Rate2

(lb ai/A)

Area 

Treated or 

Amount 

Handled 

Daily3

Dermal Inhalation

Baseline + gloves PF5 Respirator Dose 

(mg/kg/day)4 MOE5 Dose (mg/kg/day)6 MOE7

Mixer/Loader

Aerial applications of 

WDG

and

Chemigation application of 

WDG

Artichoke

Persimmon 51.6 1.792 0.18 350 0.0066 760 0.0014 160

Aerial applications of

SC

Sugarcane 37.6 0.0438 0.20 1200 0.018 270 0.00013 1,800

Mixer/Loader/Applicator

Mechanically pressurized 

handgun of WDG

Greenhouse 

tomatoes 2500 24 0.0018

lb ai/gal

1000

gal 0.0091 550 0.00054 430

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” (March 2013); 

2 Based on proposed label (See Table 4).

3 Exposure Science Advisory Council Policy #9.1.

4 Dermal Dose = Dermal Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled Daily (A or gal/day) × DAF (%) ÷ BW 

(kg).

5 Dermal MOE = Dermal NOAEL (mg/kg/day) ÷ Dermal Dose (mg/kg/day).

6 Inhalation Dose = Dermal Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled Daily (A or gal/day) ÷ BW (kg).

7 Inhalation MOE = Inhalation NOAEL (mg/kg/day) ÷ Inhalation Dose (mg/kg/day).
Page 56 of 58

Table E-3. Occupational Post-application Non-Cancer Exposure and Risk Estimates for 

Pyraclostrobin.

Crop/Site Activities

Transfer 

Coefficient 

(cm2/hr)

DFR1 Dermal Dose 

(mg/kg/day)2 MOE3

Sugarcane

Scouting 1,100

0.152

0.0027 1,800

Hand Harvesting 17,600 0.043 120

Hand Weeding 70 0.00017 29,000

Artichoke

Hand Harvesting 1,100

0.379

0.0068 740

Hand Weeding, Thinning, Pruning 70 0.00043 12,000

Irrigation

(hand set) 1,900 0.012 430

Scouting 210 0.0013 3,900

Transplanting 230 0.0014 3,500

Persimmon

Scouting, Hand pruning, Training 580

0.686

0.0065 770

Hand weeding, Propping, orchard 

maintenance 100 0.0011 4,500

Hand Harvesting 1,400 0.016 320

Transplanting 230 0.0026 2,000

Thinning 3,600 0.040 120

Greenhouse 

Tomatoes

Hand harvesting, pinching, hand pruning, 

Scouting, Turning, Tying, Hand weeding, 1200

0.379

0.0074 680

Irrigation (hand watering), Transplanting 230 0.0014 3,500

1 DFR chemical-specific study (see Appendix D, Tables D4, D5, and D6)

2 Daily Dermal Dose = [DFR (μg/cm2) × Transfer Coefficient × 0.001 mg/μg × 8 hrs/day × dermal absorption (%)]  BW (kg).

3 MOE = POD (mg/kg/day) / Daily Dermal Dose. Daily Dermal Dose = [DFR (μg/cm2) ×TC ×0.001 mg/μg ×8 hrs/day ×dermal 

absorption factor (%)]  BW (kg).
Page 57 of 58

Appendix F. Summary of Pyraclostrobin DFR Study Results

Table F-1. Summary of DFR Values and Regression Analysis Results for Treated Peach Foliage with 

Pyraclostrobin

Input/Parameter Georgia Pennsylvania California

Application Rate (lb ai/A)

(Study Target Rate = 0.12 lb ai/A) 0.12 0.12 0.12

Spray Volume (GPA) 105 92.2 152

Measured Average Day 0 Residue (μg/cm2) 0.175 0.29 0.29

Predicted Day 0 Residue (μg/cm2) 0.176 0.457 0.389

Slope -0.0963 -0.105 -0.0297

Half-life (days) 7.2 6.6 23

R

2

0.98 0.90 0.59

Table F-2. Summary of DFR Values and Regression Analysis Results for Treated Strawberry Foliage with 

Pyraclostrobin

Input/Parameter North Carolina California Oregon

Application Rate (lb ai/A)

(Study Target Rate = 0.18 lb ai/A) 0.18 0.18 0.18

Spray Volume (GPA) 45.8 45.8 45.8

Measured Average Day 0 Residue (μg/cm2) 0.505 0.431 0.19

Predicted Day 0 Residue (μg/cm2) 0.1 0.379 0.0963

Slope -0.139 -0.166 -0.106

Half-life (days) 5 4.2 6.5

R

2

0.62 0.99 0.85

Table F-3. Summary of DFR Values and Regression Analysis Results for Treated Peanut Foliage with 

Pyraclostrobin

Input/Parameter Texas Georgia North Carolina

Application Rate (lb ai/A)

(Study Target Rate = 0.25 lb ai/A) 0.25 0.25 0.25

Spray Volume (GPA) Not provided Not provided Not provided

Measured Average Day 0 Residue (μg/cm2) 0.497 0.438 0.511

Predicted Day 0 Residue (μg/cm2) 0.19 0.104 0.133

Slope -0.122 -0.104 -0.112

Half-life (days) 5.7 6.7 6.2

R

2

0.78 0.46 0.63

Note: Bolded text indicates DFR values used in exposure assessments.
Page 58 of 58

Appendix G. International Residue Limits Status Sheet

Pyraclostrobin (099100; 02/19/2013)

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US Canada Mexico2 Codex3

40 CFR §180.582. Plants: Tolerances are 

established for residues of the fungicide 

pyraclostrobin, including its metabolites and 

degradates. Compliance with the tolerance levels 

is to be determined by measuring on the sum 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]phenyl carbamate), calculated as 

the stoichiometric equivalent of pyraclostrobin.

methyl [2-[[[1-(4-

chlorophenyl)-1Hpyrazol-3-

yl]oxy]methyl]phe

nyl]methoxycarba

mate, including the 

metabolite [2-[[[1-

(4-chlorophenyl)-

1H-pyrazol-3-

yl]oxy]methyl]phe

nyl]carbamate

- Pyraclostrobin. Residue is NOT 

fat soluble.

Commodity1 Tolerance (ppm) /Maximum Residue Limit (ppm)

US Canada Mexico2 Codex3

Artichoke, globe 3.0 None 2. 

Belgium endive

(witloof chicory)

4.0 None None

Persimmon 3.0 None None

Vegetable, bulb, group 3-07 0.9 0.9 Garlic 0.15

Leek 0.7

Bulb onion 1.5

Spring onion 1.5

Vegetable, fruiting, group 8-10 1.4 Tomato 1

Pepper 1

Tomato 0.3

Pepper 0.5

Eggplant (aubergine) 0.3

Fruit, citrus, group 10-10 2.0 2.0 2

Fruit, pome, group 11-10 1.5 1.5 Apple 0.5

Oilseed group 20 0.45 0.45 0.4

Caneberry subgroup 13-07A 4.0 3.5 Blackberry 3

Bushberry subgroup 13-07B 4.0 3.5 Blueberry 4

Small fruit, vine climbing subgroup 

(except fuzzy kiwi) 13-07F

2.0 2.0 Grape 2

Low growing berry subgroup 13-

07G except cranberry

1.2 1.2 Strawberry 1.5

1

Includes only commodities of interest for this action. Tolerance values should be the HED recommendations and 

not those proposed by the applicant.

2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains. PoP = 

processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the 

fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.