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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

CHEMICAL SAFETY AND

POLLUTION PREVENTION

MEMORANDUM

DATE: December 15, 2014

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

New Uses on Dry Shelled Pea and Beans (Except Soybean) Crop Subgroup 6C 

and Sunflower Crop Subgroup 20B; Crop Group Expansion to Rapeseed 

Subgroup 20A; and Crop Group Conversions to Fruit, Stone, Group 12-12; and 

Nut, Tree, Group 14-12.

PC Code: 125619 DP Barcode: D418671

Decision No.: 487580 Registration No.: 59639-147

Petition No.: 4E8244 Regulatory Action: Section 3 Registration

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

TXR No.: NA CAS No.: 125116-23-6

MRID No.: NA 40 CFR: 180.617

FROM: Barry O’Keefe, Senior Biologist

Myron S. Ottley, Senior Biologist

Nancy Dodd, Chemist

Kristin Rury, 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: Laura Nollen, Risk Manager

Barbara Madden, Branch Chief

Risk Integration, Minor Use and Emergency Response Branch (RIMUERB)

Registration Division (7505P)

And

Hope Johnson, PM21

Fungicide 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 metconazole. The toxicology reevaluation was performed by

Myron Ottley, the drinking water assessment was conducted by Faruque Khan (EPA 

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

dietary exposure assessment were conducted by Nancy Dodd, the occupational and residential 

exposure assessment was conducted by Kristin Rury, and the human health risk assessment was

conducted by Barry O’Keefe. 
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Table of Contents

1.0 Executive Summary........................................................................................................... 5

2.0 HED Recommendations.................................................................................................... 8

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

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

2.2.2 Recommended Tolerances......................................................................................... 9

2.2.3 Revisions to Petitioned-For Tolerances.................................................................... 9

2.2.4 International Harmonization..................................................................................... 9

2.2.5 Label Modifications.................................................................................................. 10

3.0 Introduction...................................................................................................................... 10

3.1 Chemical Identity ......................................................................................................... 10

3.2 Physical/Chemical Characteristics ............................................................................. 11

3.3 Pesticide Use Pattern.................................................................................................... 11

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

3.5 Consideration of Environmental Justice.................................................................... 17

4.0 Hazard Characterization and Dose-Response Assessment.......................................... 17

4.1 Summary of Toxicological Effects.............................................................................. 18

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

4.2.1 Completeness of the Toxicology Database.............................................................. 20

4.2.2 Evidence of Neurotoxicity........................................................................................ 20

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

4.2.4 Residual Uncertainty in the Exposure Database ................................................... 20

4.3 Toxicity Endpoint and Point of Departure Selections.............................................. 21

4.3.1 Dose-Response Assessment...................................................................................... 21

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

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

4.3.4 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 .................................................................................................... 26

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 ......................................................................... 29

5.4.5 Summary Table......................................................................................................... 29

5.4.6 Dietary Assessment of Free Triazole and its Conjugates...................................... 30

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

6.1 Residential Handler Exposure .................................................................................... 30

6.2 Post-Application Exposure.......................................................................................... 30

6.3 Residential Risk Estimates for Use in Aggregate Assessment.................................. 32

6.4 Residential Bystander Post-application Inhalation Exposure ................................. 32

6.5 Spray Drift.................................................................................................................... 33
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7.0 Aggregate Exposure/Risk Characterization.................................................................. 33

7.1 Acute Aggregate Risk................................................................................................... 33

7.2 Short-Term Aggregate Risk........................................................................................ 33

7.3 Chronic Aggregate Risk .............................................................................................. 34

8.0 Cumulative Exposure/Risk Characterization ............................................................... 34

9.0 Occupational Exposure/Risk Characterization ............................................................ 35

9.1 Short-/Intermediate-Term Handler Risk................................................................... 35

9.2 Short-and Intermediate-Term Post-Application Risk.............................................. 36

9.2.1 Dermal Post-Application Risk................................................................................. 36

9.2.2 Inhalation Post-Application Risk............................................................................ 37

10.0 References......................................................................................................................... 38

Appendix A. Toxicology Profile and Executive Summaries .................................................. 39

A.1 Toxicology Data Requirements................................................................................... 39

A.2 Toxicity Profiles............................................................................................................ 40

Appendix B. Physicochemical Properties of Metconazole. .................................................... 47

Appendix C. Review of Human Research................................................................................ 48

Appendix D. Residential Handler and Post-application Exposure and Risk Estimates ..... 49

Appendix E. Occupational Handler Exposure and Risk Estimates...................................... 51

Appendix F. Summaries of Field Residue Data ...................................................................... 55

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

Introduction

Metconazole is a broad-spectrum triazole fungicide that works systemically by preventing spore 

formation and inhibiting mycelial growth. Metconazole acts primarily as an inhibitor of 

ergosterol biosynthesis, thereby interfering with synthesis of fungal cell membranes and 

providing systemic seed and seedling protection. Metconazole is currently registered on 

numerous agricultural crops and on turf and ornamentals in residential settings.

Use Profile

The Interregional Research Project No. 4 (IR-4) has proposed for use of metconazole at a 

maximum single application rate of 0.125 lb ai/A for dry shelled pea and bean (except soybean) 

crop subgroup 6C and sunflower crop subgroup 20B. IR-4 is also proposing for the expansion of

rapeseed crop subgroup 20A, and the conversion of stone fruit crop group 12-12, the maximum 

single registered application rate is 0.125 lb ai/A. For the crop group conversions of tree nut 

crop group 14-12, the maximum single application rate is 0.11 lb ai/A. The maximum 

proposed/registered yearly application rates range from 0.125 lb ai/A to 0.50 lb ai/A. 

Applicators and other handlers must wear long-sleeved shirts, long pants, chemical resistant 

gloves, socks, and shoes. Metconazole may be applied using ground, aerial, airblast, 

chemigation, and handheld equipment. The proposed restricted entry interval (REI) is 12 hours.

Exposure Profile

Exposure pathways include dietary (food and drinking water), residential, and occupational 

exposure sources. Dietary exposures are expected for acute and chronic durations. Existing

residential uses result in short-term handler exposures for adults, and short-term post-application 

exposures for adults and children. Occupational handler and post-application exposures are 

expected for short- and intermediate-term durations.

Hazard Assessment 

The liver is the primary target organ (with observed effects such as increased liver weight and 

enzyme activity, increased incidence of hypertrophy and vacuolization) in the mouse, rat, and 

dog following oral exposure to metconazole during subchronic or chronic exposure durations. 

Other adverse effects observed in oral studies were decreased body weight, and blood effects 

(reductions in erythrocyte and/or platelet parameters) in the mouse, rat, dog, and/or rabbit. 

Splenic effects including increased spleen weight and hyperplasia were observed in the mouse, 

rat, and dog at dose levels where liver effects were also observed. In dogs, lenticular 

degeneration (cataracts) and gastrointestinal irritation were observed at the high dose level(s). 

Metconazole is considered nongenotoxic and is classified as "not likely to be carcinogenic to 

humans" based on an absence of tumors in rats and mice. 

Developmental studies in rabbits show evidence of developmental effects, but only at dose levels 

that are maternally toxic. There is quantitative evidence of susceptibility in the rat 

developmental study; however, the concern is low since the developmental effects are wellcharacterized, the no observable adverse effect levels (NOAELs) are well defined, and that

dose/endpoint is used for acute dietary risk assessment for the sensitive population. Metconazole 

did not demonstrate the potential for neurotoxicity in any of the four species (mouse, rat, dog and 
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rabbit) in the database. For these reasons, the Food Quality Protection Act (FQPA) Safety Factor 

has been reduced to 1X. In accordance with the revised 40 CFR Part 158 data requirements, a 

subchronic inhalation study is required for this risk assessment but was not included in the 

existing database; therefore, a 10X database uncertainty factor has been applied to inhalation 

exposure scenarios (HASPOC, TXR0057053, J. Leshin, 10/09/2014).

Dietary Exposure

The residue chemistry 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. 

Since no observed effects could be attributed to a single dose for the general population, 

including infants and children, an acute endpoint was not established. Therefore, an acute 

dietary exposure assessment was not conducted for these population groups. However, an

unrefined acute dietary (food and drinking water) analysis was conducted for females 13 to 49 

years old. Results of the analysis are below HED’s level of concern (LOC). The acute dietary

exposure for food and drinking water for females 13 to 49 years old is 4.6% of the acute

Population Adjusted Dose (aPAD).

The results of the unrefined chronic dietary (food and drinking water) analysis are below HED’s 

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

general U.S. population is 6.6% of the chronic Population Adjusted Dose (cPAD) and 14% of the 

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

dietary exposure to metconazole.

Residential Exposure

No new residential uses were requested in this action. However, metconazole is currently 

registered for use on residential turf and ornamentals. Residential exposures from existing 

residential uses were reassessed using the updated 2012 HED Residential Standard Operating 

Procedures1(SOPs). Residential exposure is expected to be short-term only. Because dermal 

toxicity endpoints for the appropriate duration of exposure (short-term) were not identified up to 

the limit dose, only adult residential handler inhalation exposures, and residential postapplication incidental oral exposures for children have been assessed.

All residential handler inhalation exposure risk estimates were not of concern to HED (i.e., all 

margins of exposure (MOEs) >1,000), with MOE values ranging from 6,300 to 23,000,000. All 

residential post-application incidental oral exposure risk estimates were also not of concern to 

HED (i.e., all MOEs >100), with MOEs ranging from 1,000 to 450,000.

Aggregate Exposure

There is potential for short-term and chronic aggregate exposure to metconazole. The short-term 

aggregate exposure results from dietary (which is considered background exposure) and 

residential (which is considered primary) exposure pathways. The chronic aggregate exposure is 

the same as chronic dietary exposure from food and drinking water, which are all below the 

 

1

http://www.epa.gov/pesticides/science/residential-exposure-sop.html
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HED’s level of concern. The short-term aggregate MOE of 630 for children 1 to <2 years old is 

not of concern to HED. For adults, oral dietary and inhalation risk estimates were combined 

using the total aggregated risk index (ARI) methodology since the LOCs for oral dietary

exposure (100) and inhalation exposure (1,000) are different. The LOC ARI is 1; therefore, 

ARIs of less than 1 are risk estimates of concern. The short-term aggregate ARI of 5.3 is not of 

concern to HED.

Occupational Exposure

Although occupational dermal exposure is expected during treatment of agricultural crops, 

dermal hazard was not identified for metconazole. Therefore, a quantitative handler dermal risk 

assessment was not conducted. For the proposed use pattern of metconazole, all short- and 

intermediate-term occupational handler inhalation MOEs are not of concern at baseline personal 

protective equipment (PPE) except for mixing/loading water dispersible granules (WDG) for 

aerial application to canola (crop subgroup 20A), sunflower (crop subgroup 20B), and dry beans 

and peas (crop subgroup 6C) (short-term MOE = 540; intermediate-term MOE =1,900; LOC = 

1,000). With the addition of a PF5 respirator, mixing/loading WDG for aerial application to 

these crops is not of concern (MOE = 2,700). 

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

exposure assessment was not performed for metconazole 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 metconazole. Although occupational dermal 

exposure is expected following treatment of agricultural crops, dermal hazard was not identified 

for metconazole. Therefore, a quantitative post-application dermal risk assessment was not 

conducted.

The 12 hour restricted entry interval (REI) listed on the label is adequate for worker protection. 

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 Outdoor Residential Exposure Task Force 

(ORETF), and the Residential SOPs (lawns and turf) 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-exposure-data.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. 
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2.0 HED Recommendations

HED has examined the toxicology, residue chemistry, and exposure databases for metconazole. 

Pending submission of a revised Section B and a revised label as described in section 2.2.5, there 

are no toxicology or residue chemistry issues that would preclude granting the requested 

registration and establishing the recommended tolerances for metconazole on the pea and bean, 

dried shelled, except soybean, subgroup 6C and the sunflower subgroup 20B; expansion of the 

canola tolerance to the rapeseed subgroup 20A; and conversion of the established tolerances and 

registrations for the stone fruit crop group 12 and tree nut crop group 14 to the stone fruit crop 

group 12-12 and the tree nut crop group 14-12. Additional data are needed, as outlined below in 

Section 2.1. The specific tolerance recommendations are discussed in Section 2.2.

2.1 Data Deficiencies

870.3465 Subchronic Inhalation Study

 A subchronic inhalation study is required because the use of an oral point of departure 

(POD) for inhalation exposure results in MOEs as low as 380 for occupational exposure, 

which does not meet the target of 1000 for a waiver (TXR0057053, J. Leshin,

10/09/2014). Therefore, a 10X database uncertainty factor has been added for inhalation 

exposures in the absence of the required inhalation toxicity study.

Data that may be required for future uses

If additional uses increase the dairy cattle dietary burden, additional ruminant feeding studies 

conducted at higher rates may be needed.

2.2 Tolerance Considerations

2.2.1 Enforcement Analytical Method

An adequate gas chromatography method with nitrogen-phosphorus-detection (GC/NPD)

method, Valent Method RM-41C-1-1, is available for enforcement of tolerances for residues of 

metconazole (cis- and trans- isomers) in plant commodities. A confirmatory liquid 

chromatography/tandem mass spectrometry (LC/MS/MS) method, Method RM-41C-4, is 

available. For both methods, the reported limit of quantitation (LOQ) is 0.02 ppm for each 

isomer in each matrix. The method has been validated by the ACB/BEAD and was found 

adequate for enforcing tolerances for residues of metconazole in plant commodities. No 

radiovalidation data were submitted for method RM-41C-1-1; however, HED has concluded that 

because the extraction solvent used for the proposed enforcement method is similar to the 

aqueous organic solvent mixtures used in the plant metabolism studies, radiovalidation of the 

method is not required.

An adequate GC/NPD method is available for enforcement of tolerances for residues of 

metconazole (cis- and trans-isomers) in livestock commodities. The enforcement method is a 

modified version of the German multiresidue method DFG S19. The LOQ is 0.01 ppm for each 
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isomer in each matrix, for an LOQ of 0.02 ppm for total metconazole residues. An acceptable 

confirmatory procedure (gas chromatography/mass spectrometry (GC/MS)) is included for the 

method. The method has been validated by ACB/BEAD and was found adequate for enforcing 

tolerances for residues of metconazole (cis- and trans-isomers) in/on livestock commodities. No 

radiovalidation data were submitted; however, because DFG S19 is an established multiresidue 

method, these data are not required.

2.2.2 Recommended Tolerances

The petitioner’s proposed residue definition (tolerance expression) is adequate and is consistent 

with the S. Knizner memo dated 5/27/09. A summary of the proposed and recommended 

tolerances may be found in Table 2.2.2 below.

Table 2.2.2. Tolerance Summary for Metconazole.

Commodity

Established/

Proposed 

Tolerance 

(ppm)

HED 

Recommended

Tolerance 

(ppm)

Comments

(correct commodity definition)

Pea and bean, dried

shelled, except soybean,

subgroup 6C

0.15 0.15 The 0.15 ppm level harmonizes with the 

Canadian MRL.

Sunflower subgroup 20B 0.9 0.7

Rapeseed subgroup 20A 0.04 0.08 The 0.08 ppm level harmonizes with the 

Canadian MRL.

Fruit, stone, group 12-12 0.2 0.2

Nut, tree, group 14-12 0.04 0.04

Canola seed 0.04 None Remove upon establishment of rapeseed 

subgroup 20A tolerance.

Fruit, stone, group 12 0.20 None Remove upon establishment of fruit, stone, 

group 12-12 tolerance.

Nut, tree, group 14 0.04 None Remove upon establishment of nut, tree, group 

14-12 tolerance

Pistachio 0.04 None Remove upon establishment of nut, tree, group 

14-12 tolerance

2.2.3 Revisions to Petitioned-For Tolerances

The proposed tolerance on the sunflower subgroup 20B is 0.9 ppm; HED is recommending a 

decrease to 0.7 ppm based on the Office of Economic Cooperation and Development (OECD)

tolerance calculation procedures.

The proposed tolerance for the rapeseed subgroup 20A is 0.04 ppm. HED is recommending an 

increase to 0.08 ppm to harmonize with the Canadian MRL. Based on calculations using the 

OECD calculator for canola, a tolerance of 0.04 ppm would have been recommended.

2.2.4 International Harmonization

There are no Codex maximum residue limits (MRLs) established for metconazole.
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Residue definitions are harmonized with Canada. Tolerances in the US are established for 

residues of metconazole, including its metabolites and degradates. In both the US and Canada, 

compliance with the tolerance/MRL levels is determined by measuring only metconazole. The 

recommended tolerance levels are harmonized with Canada. Refer to the International Residue 

Limits (IRL) table in Appendix G.

2.2.5 Label Modifications

860.1200 Directions for Use

The Section B/label (EPA Reg. No. 59639-147) must be revised to include the following 

statement for the dried shelled pea and bean, except soybean, subgroup 6C: “Do not apply to 

cowpea or field pea used for livestock feed.”

The Section B/label should be revised to include the interval between applications for pecan and 

pistachio.

HED recommends that a PF5 respirator be required when mixing/loading WDG metconazole 

(EPA Reg. No. 59636-147) for use on canola (crop subgroup 20A), sunflower (crop subgroup 

20B), and dry beans and peas (crop subgroup 6C).

3.0 Introduction

Metconazole is a broad-spectrum triazole fungicide that works systemically by preventing spore 

formation and inhibiting mycelial growth. Metconazole acts primarily as an inhibitor of 

ergosterol biosynthesis, thereby interfering with synthesis of fungal cell membranes and 

providing systemic seed and seedling protection.

Metconazole is currently registered on numerous agricultural crops and on turf and ornamentals 

in residential settings.

With the current action, the Interregional Research Project No. 4 (IR-4), on behalf of the IR-4 

Project and the Agricultural Experiment Stations of Montana, South Dakota, North Dakota, and

Colorado (dry bean), Montana, South Dakota, Idaho, and North Dakota (dry pea), and Kansas,

Montana, South Dakota and North Dakota (sunflower), requested the establishment of permanent 

tolerances and registration for use on the pea and bean, dried shelled, except soybean, subgroup 

6C, and the sunflower subgroup 20B; expansion of the canola tolerance to the rapeseed subgroup 

20A; and conversion of the established stone fruit crop group 12 and tree nut crop group 14 to 

the stone fruit crop group 12-12 and the tree nut crop group 14-12. 

3.1 Chemical Identity

The chemical structure and nomenclature of metconazole are presented in Table 3.1.
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Table 3.1. Metconazole Nomenclature.

Chemical Structure

 cis-isomer trans-isomer

Common name Metconazole

Company experimental name KNF-S-474m (Kureha); BAS 555 F (BASF); V-10116 (Valent)

IUPAC name (1RS,5RS;1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-

ylmethyl)cyclopentanol

CAS name 5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-

ylmethyl)cyclopentanol

CAS # 125116-23-6 (cis- and trans-isomers)

115850-27-6 (cis-isomer)

115850-28-7 (trans-isomer)

End-use product/EP Metconazole 50 WDG Fungicide (EPA Reg. No. 59639-147), a water-dispersible 

granule formulation containing 50% active ingredient.

Quash 50 WDG (EPA Reg. No. 59639-147), also known as V-10116 50 WDG

3.2 Physical/Chemical Characteristics

If released to air, a vapor pressure of 1.23x10-5Pa or 9.23 x 10-8 mm Hg indicates metconazole

will exist solely in the particulate phase in the atmosphere. Particulate-phase metconazole will 

be removed from the atmosphere by wet or dry deposition. Metconazole will not volatilize from 

dry soil surfaces based upon its vapor pressure. The physiochemical properties of metconazole

are summarized in Appendix B. 

3.3 Pesticide Use Pattern

Metconazole 50 WDG Fungicide (EPA Reg. No. 59639-147) is a water-dispersible granule 

formulation containing 50% active ingredient (ai). Applications are to be made as broadcast 

foliar sprays in sufficient water for thorough coverage using ground equipment (including 

chemigation) or aerial equipment. Depending on the crop and the targeted fungal disease, single 

application rates range from 0.0625-0.125 lb ai/A. Depending on the crop, a maximum of one to 

four applications can be made with minimum retreatment intervals (RTIs) ranging from 7 to 14 

days except for pecan (interval not specified) and pistachio (2-3 week interval); the yearly

application rates range from 0.125 to 0.500 lb ai/A. Preharvest intervals (PHIs) range from 14-

35 days. Immediate plant-back is allowed for barley, corn, cotton, oat, peanut, rye, soybean, 

sugar beet, triticale, wheat, and those crops listed on the label. A 30-day plant-back interval 

(PBI) is required for Brassica leafy vegetables and leafy vegetables. A 120-day PBI applies to 

other crops.

The proposed uses of metconazole are summarized in Table 3.3.

N

N

N

H C3

H C3

HO

Cl

N

N

N

H C3

H3C

HO

Cl
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Table 3.3. Summary of Proposed Directions for Use of Metconazole.

Applic. Timing, 

Type, and 

Equip.

Formulation

[EPA Reg.

No.]

Applic. 

Rate 

(lb ai/A)

Max. 

No. 

Applic. 

per 

Year

Max. 

Yearly 

Applic. 

Rate

(lb ai/A)

PHI

(days) Use Directions and Limitations1

Dried Shelled Pea and Bean, Except Soybean, Subgroup 6C

[Dried cultivars of bean (Lupinus); bean (Phaseolus) (includes field bean, kidney bean, lima bean (dry), navy bean, pinto bean, tepary bean); bean (Vigna) 

(includes adzuki bean, blackeyed pea, catjang, cowpea, crowder pea, moth bean, mung bean, rice bean, southern pea, urd bean); broad bean (dry); chickpea; 

guar; lablab bean; lentil; pea (Pisum) (includes field pea); pigeon pea]

Postemergence; 

Broadcast foliar 

sprays;

Ground or 

aerial 

equipment; 

Chemigation

50% WDG

[59639-147]

0.08 -

0.125

2 0.25 21 Apply when conditions favor disease development and prior to infection. 

A second application may be made at a 7- to 10-day interval. 

Apply in sufficient water to obtain thorough coverage of the plant.

Apply with ground equipment in a minimum of 20 gallons per acre (GPA) 

or by air in a minimum of 5 GPA.

Two applications may be made sequentially. Use a non-group 3 fungicide 

in alternation with Metconazole 50 WDG Fungicide. 

Rapeseed Subgroup 20A

(Borage; crambe; cuphea; exchium; flax seed; gold of pleasure; hare’s ear mustard; lesquerella; lunaria; meadowfoam; milkweed; mustard seed; oil radish; 

poppy seed; rapeseed (canola varieties only); sesame; sweet rocket; cultivars, varieties and/or hybrids of these)

Broadcast foliar 

spray during 

flowering; 

ground or aerial 

equipment.

50% WDG

[59639-147]

0.0625-

0.125

1 0.125 35 Make application between 20% and 50% bloom. Apply in sufficient water 

to obtain thorough coverage of the plant. Apply with ground equipment in 

10-20 GPA or by air in a minimum of 5 GPA.

Stone Fruit, Crop Group 12-12

(Black cherry; capulin; Chinese Jujube; Nanking cherry; sweet cherry; tart cherry; cultivars, varieties and/or hybrids of these)

Broadcast foliar 

spray; 

ground or 

aerial 

equipment

50% WDG

[59639-147]

0.078-

0.125

3 0.375 14 Timing: 

For brown rot/blossom blight, green fruit rot/jacket rot, or cherry leaf spot, 

begin applications at green tip. If conditions are favorable for disease 

development, make additional applications at full bloom and at petal fall. 

For fruit brown rot, make applications 14 to 21 days prior to harvest. 

For powdery mildew, follow the brown rot/blossom blight schedule; make 

additional applications on a 10-14 day interval until terminal growth 

ceases; application can be made after harvest.
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Table 3.3. Summary of Proposed Directions for Use of Metconazole.

Applic. Timing, 

Type, and 

Equip.

Formulation

[EPA Reg.

No.]

Applic. 

Rate 

(lb ai/A)

Max. 

No. 

Applic. 

per 

Year

Max. 

Yearly 

Applic. 

Rate

(lb ai/A)

PHI

(days) Use Directions and Limitations1

Apply as a foliar spray in sufficient water to obtain thorough coverage of 

blossoms, foliage, and or fruit.

Apply with ground equipment in 100-400 GPA or by air in a minimum of 

20 GPA.

Do not make more than 2 applications after petal fall. 

Stone Fruit, Crop Group 12-12

(Apricot; Japanese apricot; nectarine and peach)

Broadcast foliar 

sprays; 

ground or 

aerial 

equipment

50% WDG

[59639-147]

0.078-

0.125

3 0.375 14 Timing: 

For brown rot/blossom blight, green fruit rot/jacket rot, scab, or shot hole, 

begin applications at early pink bud stage before infection occurs. If 

conditions are favorable for disease development, make additional 

applications at full bloom and at petal fall.

For fruit brown rot, make applications 14-21 days prior to harvest. 

For powdery mildew, follow the brown rot/blossom blight schedule; make 

additional applications on a 10-14 day interval until terminal growth 

ceases. Begin applications prior to disease development and continue at a 

7-10 day interval.

For rust, begin application when bud tissue is susceptible to disease 

development (i.e., pink, white, or red bud). If conditions are favorable for 

disease development, make a second application at full bloom or at petal 

fall.

Apply as a foliar spray in sufficient water to obtain thorough coverage of 

blossoms, foliage, and or fruit.

Apply with ground equipment in 100-400 GPA or by air in a minimum of 

20 GPA.
Page 14 of 58

Table 3.3. Summary of Proposed Directions for Use of Metconazole.

Applic. Timing, 

Type, and 

Equip.

Formulation

[EPA Reg.

No.]

Applic. 

Rate 

(lb ai/A)

Max. 

No. 

Applic. 

per 

Year

Max. 

Yearly 

Applic. 

Rate

(lb ai/A)

PHI

(days) Use Directions and Limitations1

Do not make more than 2 applications after petal fall. 

Stone Fruit, Crop Group 12-12

(American plum; beach plum; Canada plum; cherry plum; Chickasaw plum; Damson plum; Japanese plum; Klamath plum; plum; plumcot; prune plum; 

sloe)

Broadcast foliar 

spray; 

ground or 

aerial 

equipment

50% WDG

[59639-147]

0.078-

0.125

3 0.375 14 Timing: 

For brown rot/blossom blight and rust, begin applications at green tip. If 

conditions are favorable for disease development, make additional 

applications at full bloom and at petal fall. 

For powdery mildew, follow the brown rot/blossom blight schedule; make 

additional applications on a 10-14 day interval until terminal growth 

ceases.

Apply as a foliar spray in sufficient water to obtain thorough coverage of 

blossoms, foliage, and or fruit.

Apply with ground equipment in 100-400 GPA or by air in a minimum of 

20 GPA.

Do not make more than 2 applications after petal fall

Do not apply Metconazole 50 WDG Fungicide to “Stanley” type plums.” 

Sunflower Subgroup 20B

(Calendula; castor oil plant; Chinese tallowtree; euphorbia; evening primrose; jojoba; niger seed; rose hip; safflower; stokes aster; sunflower; tallowwood; 

tea oil plant; vernonia; cultivars, varieties, and/or hybrids of these)

Postemergence; 

Broadcast foliar 

spray;

Ground or 

aerial 

equipment 

50% WDG

[59639-147]

0.078 -

0.125

2 0.25 21 Apply when conditions favor disease development and prior to infection. 

A second application may be made on a 7- to 14-day interval. 

Apply as a foliar spray in sufficient water to obtain thorough coverage of 

leaves.

Apply by ground in a minimum of 20 GPA or by air in a minimum of 5 

GPA.

Two applications may be made sequentially.

Use a non-group 3 fungicide in alternation with Metconazole 50 WDG 

Fungicide. 
Page 15 of 58

Table 3.3. Summary of Proposed Directions for Use of Metconazole.

Applic. Timing, 

Type, and 

Equip.

Formulation

[EPA Reg.

No.]

Applic. 

Rate 

(lb ai/A)

Max. 

No. 

Applic. 

per 

Year

Max. 

Yearly 

Applic. 

Rate

(lb ai/A)

PHI

(days) Use Directions and Limitations1

Tree Nuts, Crop Group 14-12, Except Filbert, Pecan, and Pistachio

(African nut-tree; almond; beechnut; black walnut; Brazil nut; Brazilian pine; bunya; bur oak; butternut; Cajou nut; candlenut; cashew; chestnut; 

chinquapin; coconut; coquito nut; dika nut; English walnut; ginkgo; Guiana chestnut; heartnut; hickory nut; Japanese horse-chestnut; macadamia nut; 

mongongo nut; monkey-pot; monkey puzzle nut; Okari nut; Pachira nut; peach palm nut; pequi; Pili nut; pine nut; Sapucaia nut; tropical almond; 

yellowhorn; cultivars, varieties and/or hybrids of these)

Broadcast foliar 

spray;

Ground or 

aerial 

equipment

50% WDG

[59639-147]

0.078-

0.11 

4 0.44 25 Begin applications prior to disease development and continue at a 7 to 14 

day interval throughout the year.

Apply as a foliar spray in sufficient water to obtain thorough coverage of 

blossoms, foliage and/or fruit.

Apply in 100-400 GPA with ground equipment or in a minimum of 20 

GPA by air.

Do not make more than 2 applications after petal fall.

Filbert (Hazelnut)

Broadcast foliar 

spray;

Ground or 

aerial 

equipment

50% WDG

[59639-147]

0.11 4 0.44 25 Begin applications starting at bud swell to bud break and continue at 10 or 

14-day intervals.

Apply as a foliar spray in sufficient water to obtain thorough coverage of 

all branches. 

Apply in 100-400 GPA with ground equipment or in a minimum of 20 

GPA by air.

Do not make more than 2 sequential applications before switching to a 

non-Group 3 fungicide for resistance management.

Pecan

Broadcast foliar 

spray;

Ground or 

aerial 

equipment

50% WDG

[59639-147]

0.078-

0.11 

4 0.44 25 Begin applications when leaves reach one-half mature size. Continue to 

make scab applications if scab model predicts need.

Apply as a foliar spray in sufficient water to obtain thorough coverage of 

blossoms, foliage and/or fruit.
Page 16 of 58

Table 3.3. Summary of Proposed Directions for Use of Metconazole.

Applic. Timing, 

Type, and 

Equip.

Formulation

[EPA Reg.

No.]

Applic. 

Rate 

(lb ai/A)

Max. 

No. 

Applic. 

per 

Year

Max. 

Yearly 

Applic. 

Rate

(lb ai/A)

PHI

(days) Use Directions and Limitations1

Apply in 100-400 GPA with ground equipment or in a minimum of 20 

GPA by air.

Do not make more than 2 sequential applications before switching to a 

non-Group 3 fungicide for resistance management.

Pistachio

Broadcast foliar 

spray;

Ground or 

aerial 

equipment

50% WDG

[59639-147]

0.125 4 0.500 25 Apply prior to onset of disease development and continue on a 2 to 3 week 

interval.

Apply as a foliar spray in sufficient water to obtain thorough coverage of 

blossoms, foliage and/or fruit.

Apply in 100-400 GPA with ground equipment or in a minimum of 20 

GPA by air.

Do not make more than 2 sequential applications before switching to a 

non-Group 3 fungicide for resistance management.

1 Rotational Crop Restrictions: Immediate plant-back is allowed for barley, corn, cotton, oat, peanut, rye, soybean, sugar beet, triticale, wheat, and those crops 

listed on the label. A 30-day plant-back interval is required for Brassica Leafy Vegetables and Leafy Vegetables. Do not plant any crop, except barley, corn, 

cotton, oat, peanut, rye, soybean, sugar beet, triticale, wheat, Brassica Leafy Vegetables, Leafy Vegetables and those crops listed on the label, earlier than 120 

days after applying Metconazole 50 WDG Fungicide.
Page 17 of 58

3.4 Anticipated Exposure Pathways

Humans may be exposed to metconazole in food and drinking water, since metconazole may be 

applied directly to growing crops and application may result in metconazole reaching surface and 

ground water drinking water sources. There are existing residential uses of metconazole so there 

is exposure to residential handlers and those entering treated areas following application. In 

occupational settings, applicators may be exposed while handling metconazole. There is a 

potential for post-application exposure for workers re-entering treated fields and residents reentering treated areas. 

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

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

uses of metconazole, but also considers existing uses of metconazole, 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

These sections are based on the hazard characterization derived from previous risk assessments: 

D350369, B. O’Keefe, 10/20/08; D386421, B. O’Keefe, 09/30/2011.
Page 18 of 58

4.1 Summary of Toxicological Effects

Metconazole is a member of the triazole class of systemic fungicides which acts primarily as an 

inhibitor of ergosterol biosynthesis. The proposed mode of action for metconazole is via 

inhibition of sterol (ergosterol) biosynthesis in fungi which is consistent with altered cholesterol 

levels observed in mice and rats. 

Overall, metconazole appears to affect the liver, kidney, spleen, and various blood parameters in 

all the species tested. Dose levels at which these effects occur are similar across species. Like 

other triazoles, a primary target organ in mammalian toxicity studies is the liver. Liver toxicity

was seen in the mouse, rat, and dog following oral exposure to metconazole via subchronic or 

chronic exposure durations. While liver effects, including changes in liver weight and enzyme 

activity, have been reported consistently across multiple exposure durations and species, these 

effects were considered slight or minimal in some studies and appeared to be "adaptive" 

responses. However, based on the weight of evidence from the consistency of these reported 

effects and evidence that these effects increase in severity with exposure duration, leading to 

liver tumors in the chronic mouse study, they were considered "adverse" and formed the basis of 

the study LOAELs. Metconazole is considered non-genotoxic and the liver tumors appear to 

have been formed via a mitogenic mode of action and therefore, metconazole is classified as "not 

likely to be carcinogenic to humans" at levels that do not cause mitogenesis (see section 4.3.3). 

The established chronic RfD would be protective of mitogenesis/carcinogenesis.

Other major critical effects observed in oral studies were decreased body weight and blood 

effects (reductions in erythrocyte and/or platelet parameters) in the mouse, rat, dog and/or rabbit. 

Splenic effects including increased spleen weight and hyperplasia were observed in the mouse, 

rat and dog at dose levels where liver effects were also observed. In dogs, lenticular 

degeneration (cataracts) was observed at the highest dose tested (114 mg/kg/day). Furthermore, 

at high dietary levels, there is evidence that metconazole is a gastrointestinal irritant in the dog.

Developmental studies in rats and rabbits show evidence of developmental effects such as 

skeletal anomalies, fetal death (resorptions, post-implantation loss, decreased viability indices) 

and malformations including hydrocephaly. There was no quantitative or qualitative 

susceptibility to the fetuses of rabbits following in utero exposure to metconazole. In the two 

available prenatal developmental toxicity studies in rabbits, developmental effects (increased 

post-implantation loss and reduced fetal body weights) were observed at the same dose that 

caused maternal toxicity (reduced food consumption and alterations in hematology parameters). 

In the two-generation reproduction study in rats, offspring toxicity (reduced fetal body weights 

F2 offspring and decreased viability in F1 and F2 offspring) was observed only at the highest 

tested dose, a dose which also resulted in parental toxicity as evidenced by reduced parental body 

weight, increased incidence of fatty hepatocyte changes in male parental animals and increased 

incidence of spleen congestion in F1 parental females. In one developmental study in rats, no

susceptibility was shown. However, in a second ratdevelopmental toxicity study, skeletal 

variations (predominantly lumbar ribs) occurred at the LOAEL in the absence of maternal 

toxicity, and more severe effects such as increased incidence of post-implantation loss, 

hydrocephaly and visceral anomaliea (cranial hemorrhage, dilated renal pelvis, dilated ureters, 
Page 19 of 58

and displaced testis were reported at the next higher dose, again in the absence of maternal 

toxicity. While quantitative susceptibility is demonstrated in this study, it was not duplicated in 

the other rat developmental study, the two rabbit developmental studies or the multi-generation 

reproduction study. Furthermore, the endpoint and point of departure for risk assessment are 

based on the developmental effects seen in the fetus, for which there is a clear NOAEL.

Therefore, it is concluded that there is low concern and no residual uncertainty for pre- and/or 

post-natal toxicity. 

Metconazole did not demonstrate neurotoxicity in the available subchronic neurotoxicity study. 

Information available from the submitted studies including acute, subchronic and chronic studies 

in several species, developmental toxicity studies in the rat and rabbit and a two generation 

reproduction study in the rat do not indicate any neurotoxic signs. No effects were noted on 

brain weights and no clinical signs possibly related to neurotoxicity were noted up to and 

including the high doses in all studies. Therefore, the requirement for an acute neurotoxicity

study has been waived (TXR0056405, K. Rury, 08/09/2012).

Toxicity via the inhalation route has not been evaluated because the data requirement for a routespecific subchronic inhalation study has not been met and remains outstanding (TXR0057053, J. 

Leshin, 10/09/2014).

Acute oral and dermal toxicities are Category III, while acute inhalation is Category IV. 

Metconazole is a moderate eye irritant (Category III) and a mild skin irritant (Category IV). It is 

not a skin sensitizer.

The absorption, distribution, metabolism and excretion of metconazole were investigated in 

rats following single oral doses of cis and or cis/trans metconazole radiolabeled at the 

cyclopentyl or triazole ring (cis only). Metconazole was significantly absorbed, with the time to 

maximum plasma concentrations for male and female rats treated with either the low- or highdose occurring with 4hr. The plasma half-life of low- and high-dose rats was slightly shorter in 

males than females, ~20-25 hours and ~34 hours, respectively. Plasma pharmacokinetic studies 

showed a low potential for bioaccumulation following single or multiple dosing regimens. 

Relatively higher concentrations were found in the gastrointestinal tract, adrenals and liver. 

The pattern of metabolites was similar at the low and high dose. Metconazole metabolites 

consist primarily of mono- and poly-hydroxylated derivatives of the parent molecule. 

Hydroxylation occurs mainly on the alkyl constituents of the phenyl and cyclopentyl rings. 

Sulfate conjugation to the cyclopentyl ring hydroxyl groups was also identified. Monohydroxy

metabolites were found in the feces and di- and tri- hydroxy compounds were found more often 

in the urine. 

Initial studies showed less than 2% of the dose was expired in the air. Excretion was primarily 

via feces (80% male, 67% female) with biliary excretion being the prominent route of 

elimination with the urine being the secondary route. By 72 hours, 80% or more of the 

radioactivity was excreted. Males excreted lower amounts of radioactivity in the urine and 

greater amounts of radioactivity in the feces than females at low and high dose.
Page 20 of 58

The dermal absorption factor is 16% based on the results of an in vivo dermal absorption study

(MRID 46808450).

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

The toxicity database is considered complete and adequate for risk assessment. There was no 

evidence of neurotoxicity in the database; there is low or no concern for developmental or 

reproductive toxicity, and for susceptibility in the developing or young animal. There are no 

residual uncertainties identified in the exposure databases. Therefore, the FQPA Safety Factor 

has been reduced to 1X.

4.2.1 Completeness of the Toxicology Database

The toxicity database is considered complete and adequate for risk assessment, with the 

exception of a subchronic inhalation study. All studies needed to assess susceptibility concerns, 

such as developmental and reproduction studies, have been submitted. Additional studies needed 

to assess neurotoxicity are also available. A subchronic inhalation study is required because the 

use of an oral point of departure (POD) results in MOEs as low as 380 for occupational exposure

with the current proposed use, which the Hazard and Science Policy Council has determined is 

not sufficient to alleviate concern (TXR0057053. J. Leshin. 10/09/2014). Therefore, a 10X

database uncertainty factor has been added for inhalation exposure.

4.2.2 Evidence of Neurotoxicity

In accordance with the revised 40 CFR Part 158 data requirements, an acute and subchronic 

neurotoxicity battery is required for this risk assessment. However, requirement for an acute 

neurotoxicity study has been waived (TXR0056405, K. Rury, 08/09/2012), and an acceptable 

subchronic neurotoxicity study showed no neurotoxic effects at levels that produced systemic 

toxicity in the study, as well as in other subchronic and chronic studies. 

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

As discussed in section 4.1, the toxicity database contains five relevant guideline studies: two 

developmental studies in the rat, two developmental studies in the rabbit, and one 

multigeneration reproduction study. There was evidence of quantitative susceptibility in one 

developmental rat study, but not in the four other studies. Concern is for susceptibility low since 

susceptibility was not corroborated by the other studies; concern is low also because the 

NOAELs are well defined, and the dose/endpoint is used for acute dietary risk assessment for the 

sensitive population. 

4.2.4 Residual Uncertainty in the Exposure Database

Dietary exposure assessments were conducted using tolerance-level residues and assumed 100% 

crop treated. Therefore, the acute and chronic dietary (food only) exposure is considered an 

upper bound conservative estimate. The contribution from drinking water is minimal. HED 

concludes that the acute and chronic exposure estimates in this analysis are unlikely to 
Page 21 of 58

underestimate actual exposure. The drinking water component of the dietary assessment utilizes 

water concentration values generated by model and associated modeling parameters which are 

designed to provide conservative, health protective, high-end estimates of water concentrations 

which will not likely be exceeded. While there is potential for post-application residential 

exposure, the best data and approaches currently available were used in the metconazole 

residential assessment. The Agency used the current conservative approaches for residential 

assessment, many of which include recent upgrades to the SOPs. The Agency believes that the 

calculated risks represent conservative estimates of exposure because maximum application rates 

are used to define residue levels upon which the calculations are based. Exposures are unlikely

to be under estimated because the assessment was a screening level assessment.

4.3 Toxicity Endpoint and Point of Departure Selections

4.3.1 Dose-Response Assessment

The endpoints and points of departure (POD) for this risk assessment are based on those of a 

previous risk assessment. The rationales for each selection, along with a detailed description of 

the toxicity studies used for various exposure scenarios are presented in that risk assessment 

document (D308794. B. O’Keefe. 07/06/2006). Following is a summary:

Acute dietary endpoints: There was no appropriate single-dose endpoint identified for acute 

oral exposure of the general population to metconazole. For the Females aged 13 – 49 

population group, the POD of 12 mg/kg bw/day was established from the NOAEL of a 

developmental toxicity study, based on the increased incidence of skeletal anomalies including 

extra lumbar ribs, cervical ribs and extra pre-sacral vertebra at the LOAEL of 30 mg/kg/day. 

While these skeletal anomalies are not usually considered single dose effects, they are used as 

the basis for an acute endpoint in this case because more severe, single-dose effects occur at the 

next higher dose level (75 mg/kg/day) such as increased incidence of post-implantation loss, 

hydrocephaly and visceral anomaliea (cranial hemorrhage, dilated renal pelvis, dilated ureters, 

and displaced testis.

Chronic dietary endpoint: HED selected the NOAEL of 4.3 mg/kg/day from a two-year 

chronic study in the rat for establishing the chronic RfD, based increased spleen and liver 

weights and increased hepatocellular vacuolation and hypertrophy at the LOAEL of 13.1 mg/kg 

bw/day. These effects at the LOAEL are part of a dose-related progression of toxicity seen in 

this study, which includes adverse hematology and clinical chemistry changes as well as 

histopathological changes such as increased incidence of eosinophilic and clear-cell 

hepatocellular foci at the next higher dose level. Other studies such as the 28-day, 90-day, and 

subchronic neurotoxicity studies all confirm the chronic NOAEL of 4.3 mg/kg/day, with 

NOAELs of 9.1, 6.4, and 4.8 mg/kg/day, respectively, based collectively on decreased body 

weight, increased liver, kidney and spleen weights, hepatocellular hypertrophy and vacuolation 

at the LOAELs of 15.7 mg/kg/day and above. Therefore, the NOAEL of 4.3 mg/kg/day is 

considered the appropriate POD for this exposure scenario.

For short-term incidental oral exposure the POD of 9.1 mg/kg/day was selected from the 

NOAEL of a 28-day oral study in rats, with a NOAEL of 9.1 mg/kg/day and a LOAEL of 90.5 
Page 22 of 58

mg/kg/day), based on decreased body weight, increased liver and kidney weights, hepatocellular 

vacuolation and hypertrophy. This study was selected because (1) endpoints identified were 

observed at the appropriate duration of exposure (1-30 days) and (2) the route of exposure (oral) 

and populations and endpoints are appropriate for the populations of concern including adults, 

infants and children (this POD is protective of the developmental effects seen in the rat).

The intermediate-term incidental oral endpoint was selected from the 90-day subchronic 

study in rats. The NOAEL for this study is 6.4 mg/kg/day and the LOAEL is 19.2 mg/kg/day

based on increased hepatocellular fatty vacuolation and increased spleen weight in females. This 

study was selected because (1) endpoints identified were observed at the appropriate duration of 

exposure (1-6 months) and (2) the route of exposure (oral) and endpoints are appropriate for the 

populations of concern including adults, infants and children (this POD is protective of the 

developmental effects seen in the rat).

Short- and Intermediate- Term dermal endpoints were not selected because quantification of 

dermal risk is not required. No systemic or dermal toxicity was seen at the limit dose in a 21-day

dermal toxicity study in the rat. There are no neurotoxicity, developmental or reproductive issues 

which would raise concern for these toxicities, which are not looked for in the 21-day dermal 

study. Also, the DAF is established at 16% which suggests that any toxicities seen in the 

developmental, reproduction and neurotoxicity studies via the oral route, would be expected to 

be seen at a significantly higher dose level via the dermal exposure route. Hence the dermal risk 

quantification is not required.

For Short-term inhalation exposures, the POD of 9.1 mg/kg/day (no observed adverse effect 

level (NOAEL)) is based on an oral 28-day rat toxicity study. In the study, the effects observed 

at the lowest observed adverse effect level (LOAEL) were decreased body weight (males), 

increased liver and kidney weight and hepatocellular hypertrophy and vacuolation (males and 

females). In the absence of repeated exposure inhalation toxicity studies, an oral study for this 

population subgroup was selected and a 10X database uncertainty factor was added.

For intermediate-term inhalation exposures, the POD of 6.4 mg/kg/day (NOAEL) is based on 

an oral 90-day rat toxicity study. In the study, the effects observed at the LOAEL were increased 

spleen weight (females) and hepatic vacuolation (males). In the absence of repeated exposure 

inhalation toxicity studies, an oral study for this population subgroup was selected and a 10X 

database uncertainty factor was added.

4.3.2 Recommendation for Combining Routes of Exposure for Risk Assessment

When there are potential residential exposures to a pesticide, aggregate risk assessment must 

consider exposures from three major sources: oral, dermal and inhalation exposures. For shortand intermediate-term risk assessments, the oral and inhalation routes can be combined due to 

the common endpoint (liver toxicity) via the oral and inhalation (oral equivalent) routes. 

Quantification of dermal risk is not required. There are no potential long-term dermal or 

inhalation exposures to metconazole under the current uses.
Page 23 of 58

4.3.3 Cancer Classification and Risk Assessment Recommendation

The Cancer Assessment Review Committee (CARC) Classification is: “Not Likely to be 

Carcinogenic to Humans” based on convincing evidence that a non-genotoxic mode of action for

liver tumors was established in the mouse and that the carcinogenic effects were not likely below 

a defined dose that doesn’t cause mitogenesis based on bioassays in the rat and the mouse, 

combined with a lack of in vitro or in vivo mutagenicity (TXR# 0054211, J. Kidwell, 4/14/06). 

No quantification is required.

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

Assessment

Table 4.3.4.1. Summary of Toxicological Doses and Endpoints for Metconazole for Use in Dietary and NonOccupational Human Health Risk Assessments

Exposure/

Scenario

Point of 

Departure

Uncertainty/FQPA 

Safety Factors

RfD, PAD, Level 

of Concern for 

Risk Assessment

Study and Toxicological Effects

Acute Dietary 

(General 

Population, 

including 

Infants and 

Children)

An appropriate dose/endpoint attributable to a single dose was not observed in the available oral 

toxicity studies reviewed.

Acute Dietary

(Females 13-49 

years of age)

NOAEL= 12 

mg/kg/day

UFA= 10X

UFH= 10X

FQPA SF= 1X

Acute RfD = 0.12 

mg/kg/day

aPAD= 0.12 

mg/kg/day

Developmental toxicity in rats:

LOAEL= 30 mg/kg/day based on 

increases in skeletal variations. At 75 

mg/kg/day (the next higher dose 

level) increased incidence of postimplantation loss, hydrocephaly and 

visceral anomaliea (cranial 

hemorrhage, dilated renal pelvis, 

dilated ureters, and displaced testis) 

were reported.

Chronic 

Dietary (All 

Populations)

NOAEL= 4.3 

mg/kg/day

UFA=10X

UFH= 10X

FQPA SF= 1X

Chronic RfD = 

0.04 mg/kg/day

cPAD = 0.04 

mg/kg/day

Chronic oral toxicity study in rats: 

LOAEL = 13.1 mg/kg/day based on 

increased liver (M) weights and 

associated hepatocellular lipid 

vacuolation (M) and centrilobular 

hypertrophy(M). Similar effects were 

observed in females at 54 mg/kg/day, 

plus increased spleen weight.

Incidental Oral 

Short-Term (1-

30 days)

NOAEL= 9.1 

mg/kg/day

UFA= 10X

UFH=10X

FQPA SF= 1X

Residential LOC 

for MOE = 100

28-Day oral toxicity study in rats:

LOAEL = 90.5 mg/kg/day based on 

decreased body weight (M), increased 

liver and kidney weight and 

hepatocellular hypertrophy and 

vacuolation (M/F).

Incidental Oral 

IntermediateTerm (1-6 

months)

NOAEL= 6.4 

mg/kg/day

UFA= 10X

UFH=10X

FQPA SF= 1X

Residential LOC 

for MOE = 100

90-Day oral toxicity study in rats:

LOAEL = 19.2 based on increased 

spleen wt (F) and hepatic vacuolation 

(M).
Page 24 of 58

Table 4.3.4.1. Summary of Toxicological Doses and Endpoints for Metconazole for Use in Dietary and NonOccupational Human Health Risk Assessments

Exposure/

Scenario

Point of 

Departure

Uncertainty/FQPA 

Safety Factors

RfD, PAD, Level 

of Concern for 

Risk Assessment

Study and Toxicological Effects

Dermal Short-

(1-30 days) &

IntermediateTerm (1-6 

months)

Quantification of dermal risk is not required due to lack of systemic or dermal toxicity at the Limit 

Dose in a 21-day dermal toxicity study in the rat, the lack of neurotoxicity, and the lack of 

developmental and/or reproductive toxicity in the absence of parental effects, which were not looked 

for in the dermal toxicity.

Inhalation 

Short- Term

(1-30 days)

NOAEL= 9.1 

mg/kg/day

UFA= 10X

UFH=10X

UFDB=10X

FQPA SF= 1X

Residential LOC 

for MOE = 1000

28-Day oral toxicity study in rats:

LOAEL = 90.5 mg/kg/day based on 

decreased body weight (M), increased 

liver and kidney weight and 

hepatocellular hypertrophy and 

vacuolation (M/F).

Inhalation 

IntermediateTerm (1-6 

months)

NOAEL= 6.4 

mg/kg/day

UFA= 10X

UFH=10X

UFDB=10X

FQPA SF= 1X

Residential LOC 

for MOE = 1000

90-Day oral toxicity study in rats:

LOAEL = 19.2 mg/kg/day based on 

increased spleen wt (F) and hepatic 

vacuolation (M).

Cancer (oral, 

dermal, 

inhalation)

Classification: “Not likely to be Carcinogenic to Humans”

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). UFDB = to account for the absence of key data (i.e., lack 

of a critical study). 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 4.3.4.2. Summary of Toxicological Doses and Endpoints for Metconazole for Use in Occupational Human 

Health Risk Assessments

Exposure/

Scenario

Point of 

Departure

Uncertainty 

Factors

Level of Concern 

for Risk 

Assessment

Study and Toxicological Effects

Dermal Short-

(1-30 days) &

IntermediateTerm (1-6 

months)

Quantification of dermal risk is not required due to lack of systemic or dermal toxicity at the Limit 

Dose in a 21-day dermal toxicity study in the rat, the lack of target organ toxicity or neurotoxicity, 

and the lack of developmental and/or reproductive toxicity in the absence of parental effects which 

were not looked for in the dermal toxicity.

Inhalation 

Short-Term (1-

30 days)

NOAEL=9.1 

mg/kg/day

UFA= 10X

UFH=10X

UFDB=10X

Occupational LOC 

for MOE = 1000

28-Day oral toxicity study in rats:

LOAEL = 90.5 mg/kg/day based on 

decreased body weight (M), increased 

liver and kidney weight and 

hepatocellular hypertrophy and 

vacuolation (M/F).

Inhalation 

Intermediateterm (1-6 

months)

NOAEL=6.4 

mg/kg/day

UFA= 10X

UFH=10X

UFDB=10X

Occupational LOC 

for MOE = 1000

90-Day oral toxicity study in rats:

LOAEL = 19.2 mg/kg/day based on 

increased spleen wt (F) and hepatic 

vacuolation (M).

Cancer (oral, 

dermal, 

inhalation)

Classification: “Not Likely to be Carcinogenic to Humans”
Page 25 of 58

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). UFDB = to account for the absence of key date (i.e., lack 

of a critical study). 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 nature of the residue in crops is adequately understood based on metabolism studies on 

banana, canola, mandarin, pea, and wheat. The metabolism of metconazole was similar in all 

crops investigated. Metconazole (parent) is the residue of concern for the tolerance expression 

for primary and rotational crops. Metconazole is the residue of concern for risk assessment 

purposes in primary and rotational crops except for cereal grains; the residues of concern for risk 

assessment in cereal grains (as both primary and rotational crops) are metconazole and the 

metabolite M11.

HED also has concern for residues of 1,2,4-triazole, TA, and TAA in plants as a result of the use 

of metconazole. However, because separate endpoints for these compounds have been 

established, exposure and risks from free triazole and its conjugates will be addressed separately.

The nature of the residue in livestock (ruminants and poultry) is adequately understood. The 

residue of concern for the tolerance expression in livestock commodities is metconazole. The 

residues of concern in livestock for purposes of the risk assessment are metconazole and 

metabolites M1 (free and its glucuronic acid conjugate), M12, and M31 (free and its glucuronic 

acid conjugate).

HED also has concern for residues of 1,2,4-triazole, TA, and TAA in livestock as a result of the 

use of metconazole. However, because separate endpoints for these compounds have been 

established, exposure and risks from free triazole and its conjugates will be addressed separately.

For drinking water, the residue of concern for metconazole 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 

Assessmenta

Residues Included In 

Tolerance Expression

Plants

Primary and Rotational 

Crops, except Cereal Grains Metconazole Metconazole

Primary and Rotational 

Crops, Cereal Grains only Metconazole and M11 Metconazole

Livestock

Ruminant Metconazole; M1 and its 

glucuronic acid conjugate; M12; 

M31 and its glucuronic acid 

conjugate

Metconazole

Poultry

Drinking Water Metconazole Not Applicable
Page 26 of 58

Note: For all triazole-containing pesticides, the triazole-containing metabolites 1,2,4-T, TA, and TAA should also 

be included as residues of concern for risk assessment purposes only for plant and livestock commodities. Since 

these metabolites are common to the entire class of triazole-derivative fungicides and because of differential toxicity 

between the metabolites and the various parent compounds, risks associated with exposure to 1,2,4-T and to 

TA/TAA are addressed in separate risk assessment documents.

a M1 = 5-[(4-chlorophenyl)methyl]-2-methoxyl-2-methyl-1-(1H-1,2,4-triazol-1-ylmethyl)-1-cyclopentanol; M11 = 

5-[(4-chlorophenyl)methoxyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)-1-cyclopentanol; M12 = 5-[(4-

chlorophenyl)methyl]-2-carboxyl-2-methyl-1-(1H-1,2,4-triazol-1-ylmethyl)-1-cyclopentanol; M31 = 

(1S*,3R*,5S*)-3-hydroxy-cis-metconazole; 1,2,4-T = 1H-1,2,4-triazole; TAA = 1H-1,2,4-triazol-1-yl acetic acid; 

TA = 2-amino-3-(1H-1,2,4-triazol-1-yl)propanoic acid.

5.2 Food Residue Profile

IR-4 submitted field trial data on dry bean (MRID 49297801), dry pea (MRID 49297802), and 

sunflower (MRID 49297803). The data reflect the proposed use patterns. The number of trials 

and geographic distribution are acceptable. The analytical method used is adequate for 

determination of the residue of concern, and the samples were stored frozen for intervals 

supported by the storage stability results. A summary of the residue data from the crop field 

trials is presented in Appendix F, Tables F.1 through F.5. The existing field trial data for the 

crop group conversions are adequate.

The previously submitted field trial data on canola, cherry, peach, plum, almond, and pecan are 

adequate to support the rapeseed subgroup 20A, the stone fruit subgroup 12-12, and the tree nut 

group 14-12. The number of field trials and geographic representations are adequate. Adequate 

storage stability data are available to support the field trial data. An adequate data collection 

method, the GC/NPD method RM-41C-1, was used to determine metconazole (cis- and transisomers) in canola, stone fruit, and tree nuts. Residues of 1,2,4-triazole, TA, and TAA were 

determined in canola seed using an adequate LC/MS/MS method (Morse Laboratories Method 

160). Although stone fruit and tree nut samples were not analyzed for the triazole metabolites, 

field trial data for triazoles are not required for those petitions submitted in 2006.

Processed Food and Feed

Adequate processing studies have been submitted on canola, plum, and sunflower.

Canola: Metconazole (the sum of cis- and trans-isomers) was non-detectable in/on canola seed, 

meal and refined oil samples reflecting treatment at a 5x rate; therefore, separate tolerances are 

not required for canola meal and oil. Residues of 1,2,4-triazole were also not detectable in 

canola seed, meal and refined oil reflecting treatment at 5X. Residues of TA and TAA do not

concentrate in oil. However, residues of TA and TAA concentrated in canola meal by 2.1X and 

1.4X, respectively.

Plum: Metconazole (the sum of cis- and trans-isomers) concentrates 2.3X in prunes.

Sunflower: Metconazole (the sum of cis- and trans-isomers) does not concentrate in sunflower 

meal and oil. Residues of TA concentrate 2.9X in sunflower meal, but do not concentrate in oil. 
Page 27 of 58

Livestock

Adequate cattle and poultry feeding studies were previously submitted and reviewed. Based on 

the cattle feeding study and the calculated dietary burden based on the maximum reasonably 

balanced diet (Table 1 Feedstuffs, June 2008), no changes are required in the established 

livestock tolerances as a result of the proposed/expanded uses. The established tolerances for 

meat byproducts of cattle, goat, horse, and sheep at 0.04 ppm and for egg at 0.04 ppm are 

adequate. No tolerances are established for milk; fat and meat of cattle, goat, hog, horse, poultry, 

and sheep; or meat byproducts of hog and poultry since residues are not expected to occur in 

those commodities. If additional uses increase the dairy cattle dietary burden, additional 

ruminant feeding studies conducted at higher rates may be needed.

Rotational Crops

Adequate limited field rotational crop studies have previously been submitted. Based on the 

limited field rotational crop trials, rotational crop restrictions are included on the registered 

Metconazole 50 WDG label (EPA Reg. No. 59639-147). The same rotational crop restrictions 

on the proposed Metconazole 50 WDG label are adequate.

5.3 Water Residue Profile

The drinking water residues used in the dietary risk assessment were provided EFED (D418674, 

F. Khan, 9/30/2014) and incorporated directly into this dietary assessment in the DEEM-FCID 

into the food categories “water, direct, all sources” and “water, indirect, all sources.”

Parent metconazole is the only residue of concern considered in the drinking water assessment. 

HED determined that degradates of metconazole were not to be included (Residues of Concern 

Knowledgebase Subcommittee (ROCKS), USEPA, 2008, D348234).

For surface water, the Surface Water Concentration Calculator (SWCC v 1.106) model was used 

to generate EDWCs for the Tier II aquatic exposure assessment based on cranberry use. The 

SWCC is a graphical user interface that runs the Pesticide Root Zone Model (PRZM, v 5, 

November 15, 2006) and the Variable Volume Water Body Model (VVWM, 3/6/2014) (USEPA, 

2006b). The default percent cropped area (PCA) factor of 1.0 was used.

For peak exposure and annual mean exposure, lower EDWCs for surface water were generated 

using the Tier II Pesticide Root Zone Model and Exposure Analysis Modeling System (PRZMEXAMS), based on metconazole use on PA turf with a PCA factor of 1. The use on turf 

reflected the highest application rate (i.e., five applications at 0.6 lb ai/A/application with a 14-

day retreatment interval). The modeled EDWCs for pea/bean (dried shelled) and sunflower did 

not exceed the concentrations from PA turf.

For ground water, the PRZM-Ground Water (PRZM-GW) model was used to estimate EDWCs. 

The highest application rate, which was the application rate for turf, was modeled in estimating 

metconazole EDWCs for ground water. Since application rates for proposed uses are lower than 

turf, no additional PRZM-GW modeling was conducted.

The EDWCs used in HED’s human health dietary risk assessment are bolded in summary Table 

5.3.1 below. The ground water EDWC of 51.8 μg/L (ppb) was used in the acute dietary
Page 28 of 58

assessment. The surface water EDWC of 43.9 μg/L (ppb) was used in the chronic dietary

assessment.

The drinking water models and their descriptions are available at the EPA internet site: 

http://www.epa.gov/oppefed1/models/water/.

Table 5.3.1. Recommended EDWCs for the Proposed Uses of Metconazole for Drinking Water Sources1

Drinking Water 

Source Crop Scenario (Model)

Peak 

Exposure

(Acute)

(μg/L)

Annual Mean 

Exposure 

(Non-Cancer 

Chronic)

(μg/L)

30-year Mean 

Exposure 

(Cancer 

Chronic)

(μg/L) 

Surface Water Turf 245.5 31.3 22.8

Cranberry349.6 43.9 NA5

Ground water WI Central Sand Scenario4

51.8 NA5

20.0

1 Bolded values are the recommended EDWCs for assessing acute and chronic dietary exposures from metconazole 

uses.

2 The Tier II model PRZM/EXAMS was used to generate EDWCs for surface water, based on metconazole use on 

PA turf. A percent cropped area (PCA) factor of 1 was used.

3 The SWCC v 1.106 model was used to generate EDWCs for the Tier II aquatic exposure assessment. The SWCC 

is a graphical user interface that runs the Pesticide Root Zone Model (PRZM, v 5, November 15, 2006) and the 

Variable Volume Water Body Model (VVWM, 3/6/2014) (USEPA, 2006b). The default PCA factor of 1.0 was 

used.

4 The Tier 1 PRZM-GW model was used to reassess ground water EDWCs for the turf use, which has the highest 

application rate (5 applications at of 0.6 lbs ai/A/application).

5 Not applicable.

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 

metconazole, including its metabolites and degradates. 

An unrefined acute dietary (food and drinking water) exposure assessment was conducted. The 

residue levels used in the assessment were the established or recommended tolerance levels 

except for cereal grains and livestock commodities. Since cereal grains and livestock 

commodities include metabolites as residues of concern in the risk assessment, maximum residue 

values for the metabolites from field trials were added to the metconazole tolerance levels. 

DEEM default processing factors or empirical processing factors were used, as available. It was 

assumed that 100% of the crops were treated. 

The EDWC used in the acute dietary assessment was provided by the EFED and incorporated 

directly into the acute assessment. The ground water EDWC of 51.8 μg/L (ppb) generated by 

the PRZM-GW model was used in the acute dietary assessment. The highest application rate, 

which was the application rate for turf, was modeled using the WI Central Sand Scenario in 

estimating metconazole EDWCs for ground water. 
Page 29 of 58

An unrefined chronic dietary (food and drinking water) exposure assessment was conducted. 

The residue levels used in the assessment were the established or recommended tolerance levels 

except for cereal grains and livestock commodities. Since cereal grains and livestock 

commodities include metabolites as residues of concern in the risk assessment, maximum residue 

values for the metabolites from field trials were added to the metconazole tolerance levels. 

DEEM default processing factors or empirical processing factors were used, as available. It was 

assumed that 100% of the crops were treated. 

The EDWC used in the chronic dietary assessment was provided by EFED and incorporated 

directly into the chronic assessment. The surface water EDWC of 43.9 μg/L (ppb) generated by 

the SWCC model was used in the chronic dietary assessment. The SWCC model was used to 

generate EDWCs for the Tier II aquatic exposure assessment based on the cranberry scenario.

Metconazole 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

It was assumed that 100% of the crops were treated for all commodities.

5.4.3 Acute Dietary Risk Assessment

For the general U.S. population, including infants and children, an appropriate dose/endpoint 

attributable to a single dose was not observed in the available oral toxicity studies. The acute 

dietary (food and drinking water) exposure to metconazole is below HED’s level of concern for

females 13-49 years old, the only population subgroup of concern. For females 13-49 years old,

the acute dietary exposure estimate at the 95th percentile utilized 4.6% of the acute population 

adjusted dose (aPAD), and is not of concern.

5.4.4 Chronic Dietary Risk Assessments

The chronic dietary (food and drinking water) exposure to metconazole is below HED’s level of 

concern for the general U.S. population and all population subgroups. The chronic dietary

exposure estimates utilize 6.6% of the chronic population adjusted dose (cPAD) for the general 

U.S. population and 14% of the cPAD for children 1-2 years old, the most highly exposed 

population subgroup.

5.4.5 Summary Table

Table 5.4.5. Summary of Dietary (Food and Drinking Water) Exposure and Risk for Metconazole.

Population Subgroup

Acute Dietary

(95th Percentile) Chronic Dietary

Dietary Exposure 

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

General U.S. Population

NA NA

0.002653 6.6

All Infants (<1 year old) 0.004963 12

Children 1-2 years old* 0.005391 14
Page 30 of 58

Table 5.4.5. Summary of Dietary (Food and Drinking Water) Exposure and Risk for Metconazole.

Population Subgroup

Acute Dietary

(95th Percentile) Chronic Dietary

Dietary Exposure 

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

Children 3-5 years old 0.004749 12

Children 6-12 years old 0.003241 8.1

Youth 13-19 years old 0.002045 5.1

Adults 20-49 years old 0.002549 6.4

Adults 50-99 years old 0.002166 5.4

Females 13-49 years old* 0.005500 4.6 0.002179 5.4

*The subpopulations with the highest risk estimates are bolded. 

NA = not applicable.

5.4.6 Dietary Assessment of Free Triazole and its Conjugates

The proposed new uses of metconazole did not result in an increase in dietary exposure estimates 

for free triazole or conjugated triazoles. Therefore, the last dietary exposure analyses for the 

triazole metabolites (D414951, T. Morton, 10/24/2013) did not need to be updated. The past 

assessment will still adequately cover these uses.

6.0 Residential (Non-Occupational) Exposure/Risk Characterization

No new residential uses are being proposed at this time. However, there are existing uses of 

metconazole on turf and ornamentals in residential settings that have been reassessed in this 

document to reflect HED’s 2012 Residential SOPs2along with policy changes for body weight 

assumptions. Because dermal toxicity endpoints for the appropriate duration of exposure (shortterm) were not identified up to the limit dose, only residential handler inhalation exposures/risks 

for adults, and residential post-application incidental oral exposures/risks for children have been 

assessed.

6.1 Residential Handler Exposure

Summaries of the short-term inhalation risk estimates for residential handlers are included in 

Appendix D, Table D.1. The maximum application rate for each exposure scenario is presented 

as the worst case scenario. All inhalation risk estimates are greater than the LOC of 1,000; and 

therefore are not of concern (MOEs range from 6,300 to 23,000,000). Dermal handler risk 

assessments were not conducted because an adverse systemic dermal hazard was not identified 

for metconazole.

6.2 Post-Application Exposure

Summaries of the short-term post-application incidental oral risk estimates for children 1 to <2 

years old are included in Appendix D, Table D.2. The maximum application rate for each 

exposure scenario is presented as the worst-case scenario. All incidental oral risk estimates are 

 

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

greater than the LOC of 100; and therefore are not of concern (MOEs range from 1,000 to 

450,000). Dermal post-application risk assessments were not conducted because an adverse 

systemic dermal hazard was not identified for metconazole.

Guideline 875.2100 - Turf Transferable Residues (TTR)

In accordance with 40CFR158, TTR data are required for all occupational (e.g., sod farms, golf 

courses, parks, and recreational areas) or residential turf uses that could result in post-application 

exposure to turf. In the absence of chemical-specific TTR data, EPA uses default values. The 

2012 Standard Operating Procedures for Residential Pesticide Exposure Assessment includes an 

analysis of all TTR data, available at the time, which resulted in the selection of revised liquid 

and granular default values for the fraction of the application rate available for transfer after a 

turf application (FAR). These values are based on an analysis of 59 TTR studies performed with 

the Modified California Roller Method (36 studies using liquids, 11 studies using wettable 

powders/water dispersible granules, and 12 studies using granules). The liquid results (N=131) 

indicate a range of FAR values from 0.0005% to 6.1% and the granular results (N=37) indicate a 

range of 0.00064% to 0.69%. In both the liquid and granular data, a large range of transferability 

is observed and this variability can potentially be attributable to many factors such as active 

ingredient; formulation; field conditions in the studies; weather conditions (e.g. humidity); or 

many other difficult to quantify factors. Although witnessed across multiple chemicals, this 

range in FAR values is not expected when considering TTR data for a single chemical. HED 

selected 1% and 0.2% as high-end default values for liquid and granular products, respectively.

Because TTR data are not available for metconazole, EPA is using the default value of the 

currently registered residential products. Although there may be a small degree of uncertainty in 

the use of the default TTR value for metconazole (i.e., there is a small chance that the FAR value 

may exceed the applicable default value), it is likely that the health-protective aspects of EPA’s 

residential post-application turf assessment methodology will more than compensate for this 

potential uncertainty (i.e. the methodology is likely to overestimate exposure by a factor greater 

than the factor than the highest measured FAR values exceed the defaults). For example, when 

assessing residential post-application turf exposure, EPA assumes the following: exposures occur 

to zero-day (i.e., day of application ) residues every day of the assessed exposure duration (i.e.,

EPA assumes that no dissipation or degradation occurs, it doesn’t rain, the grass is not mowed, 

etc); individuals perform the same post-application activities performed in the turf transfer 

coefficient study day after day (e.g. tumbling, playing on turf with toys, etc.); and individuals 

engage in these post-application activities for a high-end amount of time every day that is 

represented by data reflecting time children spend outdoors and not specifically engaged in 

activities on turf, when in actuality children do not spend all of their outdoor time on turf and 

high-end levels of activity will not occur every day. 

Given the conservatisms discussed above and the potential compounding nature of these 

conservatisms, EPA is able to rely upon the calculated exposure estimates with confidence that 

exposure is not being underestimated.

Since the estimated residential turf post-application exposure for residential turf using default 

TTR values for metconazole is minimal in comparison to the level of concern (i.e., the calculated 

MOE is greater than 10 times higher than the level of concern, MOE = 1,000 compared to the 

LOC of 100); EPA is waiving the 40 CFR TTR data requirement. In this instance, it is unlikely
Page 32 of 58

that chemical-specific TTR data would be needed to further refine exposure assessments or 

would add appreciably to our general understanding of the availability of turf transferable 

pesticide residues. 

Guideline 875.2100 - Dislodgeable Foliar Residue (DFR)

In accordance with 40 CFR 158, DFR data are required for all occupational (e.g., crop, nursery, 

greenhouse use sites) or residential (e.g., ornamental and vegetable gardens, pick your own 

farms, retail tree farms) uses that could result in post-application exposure to foliage. Since 

metconazole does not result in adverse systemic toxicity via the dermal route of exposure, EPA 

is waiving the 40 CFR DFR data requirement at this time.

6.3 Residential Risk Estimates for Use in Aggregate Assessment

Table 6.3.1 reflects the residential risk estimates that are recommended for use in the aggregate 

assessment for metconazole.

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

reflects inhalation exposure from WDG applications to turf with a manually pressurized 

handwand.

 The recommended residential exposure estimate for use in the children 1<2 years old 

aggregate assessment reflects hand-to-mouth exposures from WDG metconazole 

application to turf.

Table 6.3.1. Recommendations for the Residential Exposures for the Metconazole Aggregate Assessment.

Lifestage Exposure 

Scenario

Dose (mg/kg/day)1 MOE2

Dermal Inhalation Oral Total Dermal Inhalation Oral Total

Adult

Manually 

Pressurized 

Handwand 

Lawns/Turf 

(WDG)

N/A 0.00024 N/A 0.00024 N/A 6,300 N/A 6,300

Child (ShortTerm)

Hand-to-Mouth 

from WDG 

Application to 

Lawns/Turf

N/A N/A 0.0091 0.0091 N/A N/A 1,000 1,000

1 Dose = the highest dose for each applicable lifestage of all residential scenarios assessed. Table D.1.in Appendix D presents that Residential 

Handler Exposure and Risk Estimates and Table D.2 in Appendix D presents the Residential Post-application Exposure and Risk Estimates.

2 MOE = the MOEs associated with the highest residential doses. 

6.4 Residential Bystander Post-application Inhalation Exposure

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, 2010 (http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html). The 

agency has evaluated the SAP report and has developed a Volatilization Screening Tool and a 

subsequent Volatilization Screening Analysis 

(http://www.regulations.gov/#!docketDetail;D=EPA-HQ-OPP-2014-0219). 
Page 33 of 58

During Registration Review, the agency will utilize this analysis to determine if data (i.e., flux 

studies, route-specific inhalation toxicological studies) or further analysis is required for 

metconazole.

6.5 Spray Drift

Spray drift is a potential source of exposure to those nearby pesticide applications. This is 

particularly the case with aerial application, but, to a lesser extent, spray drift can also be a 

potential source of exposure from the ground application methods (e.g., groundboom and 

airblast) employed for metconazole. The Agency has been working with the Spray Drift Task 

Force (a task force composed of various registrants which was developed as a result of a Data 

Call-In issued by EPA), 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 information).3 The Agency is also taking means to qualitatively and 

qualitatively address spray drift as a potential source of exposure in risk assessments for 

pesticides through existing programs such as Ag Drift and chemical specific properties of 

pesticides. The potential for spray drift will be quantitatively evaluated for each pesticide during 

the Registration Review process which ensures that all uses for that pesticide will be considered 

concurrently.

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 metconazole, 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 metconazole in food and 

drinking water, and does not include dermal, inhalation, or incidental oral exposure. As 

demonstrated under section 5.4.3, acute aggregate risks are not of concern. 

7.2 Short-Term Aggregate Risk

There is potential short-term exposure to metconazole 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. For a description of 

the residential exposure scenarios considered in the aggregate assessment, see Section 6.3. 

 

3 Available: http://www.epa.gov/opp00001/factsheets/spraydrift.htm 
Page 34 of 58

The short-term aggregate MOE is 630 for children 1 to <2 years old, which are not of concern to 

HED. For adults, oral dietary and inhalation risk estimates were combined using the total 

aggregated risk index (ARI) methodology since the LOCs for oral dietary exposure (100) and 

inhalation exposure (1,000) are different. The LOC ARI is 1; therefore, ARIs of less than 1 are 

risk estimates of concern. The short-term aggregate ARI of 5.3 is not of concern to HED.

Table 7.2.1. Short-Term Aggregate Risk Calculations 

Lifestage Residential Exposure 

Scenario

Incidental Oral or Inhalation

Exposure Oral Dietary Exposure Total 

Combined 

MOE2

Total 

Combined 

ARI NOAEL 3

mg/kg/day

Exposure

mg/kg/day MOE1 NOAEL mg/kg/day

Chronic Dietary 

(Food + Water) 

mg/kg/day

MOE1

Child 1 to 

<2 yrs

Post-application handto-mouth activities on

treated turf

9.1 0.0091 1,000 9.1 0.005391 1,700 630 NA

Adult Inhalation Exposure to 

Handlers on Turf 9.1 0.00024 6,300 9.1 0.002653 3,400 NA 5.3

1 The Level of Concern MOE is 100.

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

3 Aggregate Risk Index (ARI) = 1÷ (1 ÷ RIoral dietary) + (1 ÷ RIinhalation) 

 Risk Index (RI) = MOE ÷ LOC; Inhalation LOC = 1,000 and Oral Dietary LOC = 100

Updated Aggregate Assessment of Free Triazole & its Conjugates

The addition of the new proposed uses does not increase the aggregate exposure to free triazoles 

and its conjugates. Therefore, the recently updated aggregate human health risk assessment for 

free triazoles and its conjugates remains unchanged and the aggregate estimates are below 

HED’s level of concern (D414952, T. Morton, 10/24/2013).

7.3 Chronic Aggregate Risk

Chronic exposure from the residential pathway is not anticipated based on the current 

metconazole 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). See 

Section 5.4.4 for details.

8.0 Cumulative Exposure/Risk Characterization

Metconazole is a member of the triazole-containing class of pesticides. Although conazoles act 

similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a 

relationship between their pesticidal activity and their mechanism of toxicity in mammals. 

Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to 

establish that the chemicals operate by the same, or essentially the same, sequence of major 

biochemical events (EPA, 2002). In conazoles, however, a variable pattern of toxicological 

responses is found; some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid 

tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. 

Furthermore, the conazoles produce a diverse range of biochemical events including altered 

cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood 

whether these biochemical events are directly connected to their toxicological outcomes. Thus, 

there is currently no evidence to indicate that conazoles share common mechanisms of toxicity

and EPA is not following a cumulative risk approach based on a common mechanism of toxicity

for the conazoles. For information regarding EPA’s procedures for cumulating effects from 
Page 35 of 58

substances found to have a common mechanism of toxicity, see EPA’s website at 

http://www.epa.gov/pesticides/cumulative.

Metconazole is a triazole-derived pesticide. This class of compounds can form the common 

metabolite 1,2,4-triazole and two triazole conjugates (triazolylalanine and triazolylacetic acid). 

To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, 

including metconazole, U.S. EPA conducted a human health risk assessment for exposure to 

1,2,4-triazole, triazolylalanine, and triazolylacetic acid resulting from the use of all current and 

pending uses of any triazole-derived fungicide. The risk assessment is a highly conservative, 

screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of 

a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures 

(i.e., high end estimates of both dietary and non-dietary exposures). In addition, the Agency

retained the additional 10X FQPA safety factor for the protection of infants and children. The 

assessment includes evaluations of risks for various subgroups, including those comprised of 

infants and children. The Agency’s complete risk assessment is found in the propiconazole 

reregistration docket at http://www.regulations.gov, Docket Identification (ID) Number EPAHQ-OPP-2005-0497.

9.0 Occupational Exposure/Risk Characterization

Metconazole has been proposed for use on dry shelled pea and beans (except soybean) crop 

subgroup 6C and sunflower crop subgroup 20B. The petitioner also requested a crop group 

expansion to rapeseed crop subgroup 20A; and crop group conversions to stone fruit crop group 

12-12, and tree nut crop group 14-12. HED reevaluated the existing occupational uses for 

rapeseed crop subgroup 20A, stone fruit crop group 12-12, and tree nut crop group 14-12 to 

incorporate updated occupational exposure assessment assumptions and the revised LOC for 

inhalation exposure assessment. The application rates presented for rapeseed crop subgroup 

20A, stone fruit crop group 12-12, and tree nut crop group 14-12 represent the maximum 

registered application rates, or the worst-case exposure scenarios.

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 label, types of equipment and techniques 

that can potentially be used, occupational handler exposure is expected from the proposed uses. 

Because dermal toxicity endpoints for the appropriate duration of exposure (short- and 

intermediate-term) were not identified up to the limit dose, only occupational handler inhalation 

exposures/risks have been assessed. For inhalation exposures, an additional 10X uncertainty 

factor is added because of the lack of an available subchronic inhalation toxicity study. 

Therefore, the total uncertainty factor that has been applied to the inhalation assessments of 
Page 36 of 58

metconazole is 1000X for handler exposure. Occupational inhalation exposure and risk resulting 

in MOEs greater than or equal to 1000 will not be of concern to HED (LOC = 1000). 

For the proposed uses of metconazole, all short- and intermediate-term occupational handler 

MOEs are not of concern at baseline PPE except for mixing/loading WDG for aerial application 

to canola (crop subgroup 20A), sunflower (crop subgroup 20B), dry beans and peas (crop 

subgroup 6C) (short-term MOE = 540; intermediate-term MOE =1,900; LOC = 1,000). With the 

addition of a PF5 respirator, mixing/loading WDG for aerial application to these crops is not of 

concern (MOE = 2,700). Summaries of the short- and intermediate-term risk estimates for 

occupational handlers applying metconazole are provided in Appendix E, Tables E.1 and E.2. 

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

Because dermal toxicity endpoints for the appropriate duration of exposure (short- and 

intermediate-term) were not identified up to the limit dose, post-application dermal 

exposures/risks were not assessed.

Guideline 875.2100 - Dislodgeable Foliar Residue

In accordance with 40 CFR 158, DFR data are required for all occupational (e.g., crop, nursery, 

greenhouse use sites) or residential (e.g., ornamental and vegetable gardens, pick your own 

farms, retail tree farms) uses that could result in post-application exposure to foliage. Since 

metconazole does not result in adverse systemic toxicity via the dermal route of exposure, EPA 

is waiving the 40 CFR DFR data requirement at this time. In this instance, it is unlikely that 

chemical-specific DFR data would be needed to further refine exposure assessments or would 

add appreciably to our overall understanding of the availability of dislodgeable foliar pesticide 

residues for metconazole.

Restricted Entry Interval

Since a quantitative dermal assessment was not required, the REI is based on the acute toxicity

of metconazole. Metconazole is classified as Toxicity Category III via the dermal route and 

Toxicity Category IV for skin 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 irritation are assigned a 12-hour REI. Therefore, the [156 subpart K] Worker Protection 

Statement REI of 12 hours is adequate to protect agricultural workers from post-application 

exposures to metconazole.
Page 37 of 58

9.2.2 Inhalation Post-Application Risk

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, 2010 

(http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html). The agency has 

evaluated the SAP report and has developed a Volatilization Screening Tool and a subsequent 

Volatilization Screening Analysis (http://www.regulations.gov/#!docketDetail;D=EPA-HQOPP-2014-0219). During Registration Review, the agency will utilize this analysis to determine

if data (i.e., flux studies, route-specific inhalation toxicological studies) or further analysis is 

required for metconazole.

In addition, the Agency is continuing to evaluate the available post-application inhalation 

exposure data generated by the Agricultural Reentry Task Force. Given these two efforts, the 

Agency will continue to identify the need for and, subsequently, the way to incorporate 

occupational post-application inhalation exposure into the agency's risk assessments.

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.

It should be noted that there is the potential for inhalation exposure during the mechanical 

sweeping and windrowing of the tree nuts. However, since there is a long PHI of 25 days, the 

post-application inhalation exposure potential is negligible and was not quantitatively assessed.

Furthermore, inhalation exposure during dusty mechanical activities such as shaking and 

mechanical harvesting is another potential source of post-application inhalation exposure.

However, the airblast applicator scenario is believed to represent a reasonable worst case 

surrogate estimate of post-application inhalation exposure during these dusty mechanical 

harvesting activities. The non-cancer inhalation risk estimate for commercial airblast application 

is not of concern (i.e., MOE >1,000)
Page 38 of 58

10.0 References

N. Dodd, 11/07/2014, D423622. Metconazole Acute and Chronic Aggregate Dietary (Food and 

Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Actions on Pea 

and Bean, Dried Shelled, except Soybean, Subgroup 6C and the Sunflower Subgroup 20B; 

Expansion of the Canola Tolerance to the Rapeseed Subgroup 20A; and Conversion of the 

Established Stone Fruit and Tree Nut Crop Groups to the Stone Fruit Group 12-12 and the Tree 

Nut Group 14-12.

N. Dodd, 11/04/2014, D423623. Metconazole. Petition for the Establishment of Permanent 

Tolerances and Registration for Use on the Pea and Bean, Dried Shelled, except Soybean, 

Subgroup 6C and the Sunflower Subgroup 20B; Expansion of the Canola Tolerance to the 

Rapeseed Subgroup 20A; and Conversion of the Established Stone Fruit and Tree Nut Crop 

Groups to the Stone Fruit Group 12-12 and the Tree Nut Group 14-12. Summary of Analytical 

Chemistry and Residue Data.

K. Rury, 12/11/2014, D423992. METCONAZOLE. Occupational and Residential Exposure 

Assessment for Proposed Uses on Dry Shelled Pea and Beans (Except Soybean) Crop Subgroup 

6C and Sunflower Crop Subgroup 20B; Crop Group Expansion to Rapeseed Subgroup 20A; and 

Crop Group Conversions to Fruit, Stone, Group 12-12; and Nut, Tree, Group 14-12. Also a ReEvaluation of all existing Residential Uses of Metconazole.

F. Khan, 09/30/2014, D418674. Drinking Water Exposure Assessment for the Section 3 New 

Use of Metconazole on Pea and Bean (Dried Shelled, Subgroup 6C), and Sunflower (Subgroup 

20B).

T. Morton, 10/24/2013, D414951. Common Triazole Metabolites: Updated Dietary (Food + 

Water) Exposure and Risk Assessment to Address The New Section 3 Registrations For Use of 

Propiconazole on Rapeseed Crop Subgroup 20A; Use of Difenoconazole on Rapeseed Crop 

Subgroup 20A; and Use of Tebuconazole on Imported Oranges.

T. Morton, 10/24/2013, D414952. Common Triazole Metabolites: Updated Aggregate Human 

Health Risk Assessment to Address The New Section 3 Registrations For Use of Propiconazole 

on Rapeseed Crop Subgroup 20A; Use of Difenoconazole on Rapeseed Crop Subgroup 20A; and 

Use of Tebuconazole on Imported Oranges.
Page 39 of 58

Appendix A. Toxicology Profile and Executive Summaries

A.1 Toxicology Data Requirements

The requirements (40 CFR 158.500) for food uses of metconazole are in the table below. Use of 

the new guideline numbers does not imply that the new (1998) guideline protocols were used.

Test Technical

Required Satisfied

870.1100 Acute Oral Toxicity.......................................................

870.1200 Acute Dermal Toxicity ..................................................

870.1300 Acute Inhalation Toxicity..............................................

870.2400 Primary Eye Irritation....................................................

870.2500 Primary Dermal Irritation ..............................................

870.2600 Dermal Sensitization......................................................

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

870.3100 Oral Subchronic (rodent)...............................................

870.3150 Oral Subchronic (nonrodent).........................................

870.3200 21-Day Dermal ..............................................................

870.3250 90-Day Dermal ..............................................................

870.3465 90-Day Inhalation..........................................................

yes

yes

yes

no

yes

yes

yes

yes

--

no*

870.3700a Developmental Toxicity (rodent)...................................

870.3700b Developmental Toxicity (nonrodent).............................

870.3800 Reproduction .................................................................

yes

yes

yes

yes

yes

yes

870.4100a Chronic Toxicity (rodent)..............................................

870.4100b Chronic Toxicity (nonrodent)........................................

870.4200a Oncogenicity (rat)..........................................................

870.4200b Oncogenicity (mouse)....................................................

870.4300 Chronic/Oncogenicity....................................................

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

870.5100 Mutagenicity—Gene Mutation - bacterial.....................

870.5300 Mutagenicity—Gene Mutation - mammalian................

870.5xxx Mutagenicity—Structural Chromosomal Aberrations...

870.5xxx Mutagenicity—Other Genotoxic Effects.......................

yes

yes

yes

yes

yes

yes

yes

yes

870.6100a Acute Delayed Neurotox. (hen).....................................

870.6100b 90-Day Neurotoxicity (hen)...........................................

870.6200a Acute Neurotox. Screening Battery (rat) .......................

870.6200b 90-Day Neuro. Screening Battery (rat)..........................

870.6300 Develop. Neuro..............................................................

no

no

yes

yes

no

no

no

waived **

yes

no

870.7485 General Metabolism ......................................................

870.7600 Dermal Penetration........................................................

870.7800 Immunotoxicity .............................................................

yes

no

yes

yes

yes

yes

Special Studies for Ocular Effects

Acute Oral (rat)...........................................................

Subchronic Oral (rat) ..................................................

Six-month Oral (dog)..................................................

no

no

no

no

no

no

* TXR0057053, J. Leshin, 10/09/2014 waiver not granted

** TXR0056405, K. Rury, 08/09/2012 waiver granted
Page 40 of 58

A.2 Toxicity Profiles

Table A.2.1. Acute Toxicity of Metconazole

Table A.2.1. Acute Toxicity Profile – Metconazole Technical

Guideline No. Study Type MRID(s) Results Toxicity Category

870.1100 Acute oral [mouse] 44721512 LD50 = >566 mg/kg III

870.1100 Acute oral [rat] 44721512 LD50 = >566 mg/kg III

870.1100 Acute oral [rat] 44721513 LD50 = >1459 mg/kg III

870.1100 Acute oral [rat] 44721514 LD50 = >5000 mg/kg IV

870.1200 Acute dermal [rat] 44721512 Dermal LD50 > 2000 III

870.1200 Acute dermal [rabbit] 44721512 Dermal LD50 > 2000 III

870.1200 Acute inhalation [rat] 44721512 LD50 = >5.6 mg/L IV

870.2400 Acute eye irritation [rat] 44721513 moderate irritant III

870.2500 Acute dermal irritation [rabbit] 44721513 mild irritant IV

870.2600 Skin sensitization [guinea pig] 44721513 neg. -

Table A.2.2. Non-acute Toxicity Profile for Metconazole

Table A.2.2. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1

Guideline 

No. 

Study Type MRID No. (year)/ 

Classification /Doses

Results

870.3100 28-Day oral toxicity 

rodents (rat)

44721515 (1990)

M/F: 0, 30, 100, 1000, 3000 

ppm

M: 0, 2.7, 9.1, 90.5, 261.1 

mg/kg/day 

F: 0, 3.1, 10.1, 97, 287.4 

mg/kg/day

Acceptable/guideline

NOAEL (M/F) = 9.1/10.1 mg/kg/day

LOAEL (M/F) = 90.5/97 mg/kg/day based on 

depression of body weight in M, liver and 

kidney weight increases with associated 

histopathological effects (hypertrophy and 

fatty vacuolation) in liver only.

870.3100 90-Day oral toxicity 

rodents (rat)

44721517 (1991)

M/F: 0, 30, 100, 300, 1000, 

3000 ppm

M: 0, 1.94, 6.4, 19.2, 64.3, 

192.7 mg/kg/day 

F: 0, 2.1, 7.2, 22.1, 71.4, 

208.0 mg/kg/day

Acceptable/guideline

NOAEL (M/F) = 6.4/7.2 mg/kg/day

LOAEL (M/F) = 19.2/22.1 mg/kg/day based 

on increased spleen weight in females and 

hepatic vacuolation in males.
Page 41 of 58

Table A.2.2. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1

Guideline 

No. 

Study Type MRID No. (year)/ 

Classification /Doses

Results

870.3100 90-Day oral toxicity 

rodents (mouse)

44721519 (1991)

M/F: 0, 30, 300, 3000 (wk 

1)/2000(wk 2-13) ppm

M: 0, 9.58, 50.5, 341.1 

mg/kg/day 

F: 0, 6.94, 60.7, 438.5 

mg/kg/day

Acceptable/guideline

NOAEL (M/F) = 9.58/6.94 mg/kg/day

LOAEL (M/F) = 50.5/60.7 mg/kg/day based 

on increase in absolute and relative liver 

weights, hepatocellular hypertrophy and 

vacuolation, and increase in relative spleen 

weight (F), elevated AST and ALT activity. 

870.3150 28-Day oral toxicity 

non-rodents (dog)

44721520 (1991)

M/F: 0, 100, 1000, and 

7000-10000 ppm in diet

Unacceptable/non-guideline 

(some preliminary test data 

provided)

NOAEL (M/F) = 100 ppm in diet

LOAEL (M/F) = 1000 ppm in diet (increase in 

relative and absolute thyroid wt. in one/two 

females)

Deficiencies: low n (2M/2F per dose); 

decrease in food consumption means low 

exposure to test compound; actual dose 

received per dose group not provided.

870.3150 90-Day oral

toxicity non-rodents 

(dog)

44721521 (1991)

M/F: 0, 60, 600, 6000 ppm 

in diet

M: 0, 2.5, 24.4, 225.2 

mg/kg/day 

F: 0, 2.6, 24.3, 206.6 

mg/kg/day

Acceptable/guideline

NOAEL (M/F) = 2.5/2.6 mg/kg/day

LOAEL (M/F) = 24.4/24.3 mg/kg/day based 

on decreased food consumption in females and 

elevated platelets and reticulocytes in males.

870.3200 21-day Dermal 

Toxicity

46808439 (2006)

0, 250, 500, 1000 

mg/kg/day 

Acceptable/guideline

NOAEL: 1000 mg/kg

LOAEL: > 1000 mg/kg

No evidence of dermal toxicity.

870.6200 Subchronic (13-

week) Oral 

Neurotoxicity- rat

46808440 (2002)

0, 50, 170, 500 ppm

M: 0, 4.84, 15.69, 47.08 

mg/kg/day

F: 0, 5.10, 17.62, 49.82 

mg/kg/day

Acceptable/Non-guideline

Systemic NOAEL (M/F) = 4.84/5.10 mg/kg/

Systemic LOAEL (M/F) = 15.69/ 17.62 

mg/kg/ based on decreases in body weight and 

food consumption. 

Neurotoxicity NOAEL (M/F)  47.08/49.82 

mg/kg/day 
Page 42 of 58

Table A.2.2. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1

Guideline 

No. 

Study Type MRID No. (year)/ 

Classification /Doses

Results

870.3700 Prenatal development 

in rodents (rat)

44721522 (1991)

0, 12, 30, 75 mg/kg/day

Gavage

Acceptable/Guideline

Maternal NOAEL = 75 mg/kg/day

LOAEL > 75 mg/kg/day, not established.

Decreased body weight gain was observed at 

30 mg/kg/day and higher, upon which the 

maternal LOAEL was based in previous risk 

assessments. However, body weight gain 

changes without changes in absolute body 

weight are not currently considered an adverse 

effect, so there is currently no maternal 

LOAEL.

Developmental NOAEL = 12 mg/kg/day

LOAEL = 30 mg/kg/day based on increased 

incidence of skeletal variations 

(predominantly lumbar ribs). At 75 mg/kg/day 

increased incidence of post-implantation loss, 

hydrocephaly and visceral anomaliea (cranial 

hemorrhage, dilated renal pelvis, dilated 

ureters, and displaced testis) were reported.

870.3700 Prenatal development 

in rodents (rat)

46808443 (2002)

0, 1, 4, 16, 64 mg/kg/day

Gavage

Acceptable/Guideline

Maternal NOAEL= 16 mg/kg/day

LOAEL= 64 mg/kg/day based on decreased 

body weight and food consumption, increased 

placental weight and increased incidence of 

swollen placenta.

Developmental NOAEL= 16 mg/kg/day 

LOAEL= 64 mg/kg/day based on based on an 

increase in early and late resorptions, 

decreased fetal body weight and increased 

incidence of incomplete ossification of 

sternebrae.

870.3700 Prenatal 

developmental in 

non-rodents (rabbit)

Definitive Study

44721602 (1997)

0, 5, 10, 20, 40 mg/kg/day 

gavage

Acceptable/Guideline

Maternal NOAEL = 20 mg/kg/day

LOAEL = 40 mg/kg/day based on reduction in 

food consumption, and changes in various 

hematology parameters (reductions in 

hematocrit, hemoglobin, mean corpuscular 

volume and increases in platelet counts and 

alkaline phosphatase activity).

Developmental NOAEL = 20 mg/kg/day

LOAEL = 40 mg/kg/day based on increases in 

post-implantation losses.
Page 43 of 58

Table A.2.2. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1

Guideline 

No. 

Study Type MRID No. (year)/ 

Classification /Doses

Results

870.3700 Prenatal 

developmental in 

non-rodents (rabbit)

44721603 (1991)

0, 4, 10, 25, 62.5 mg/kg/day 

(Exp. #1)

0, 2, 4, 10 mg/kg/day (Exp. 

#2)

Acceptable/Guideline

Maternal NOAEL = 25 mg/kg/day

LOAEL = 62.5 mg/kg/day based on body 

weight changes and slight clinical signs 

(anorexia/reduced or altered fecal output, cold 

ears).

Developmental NOAEL = 4 mg/kg/day

LOAEL = 10 mg/kg/day based on examining 

data from the two experiments. Effects at 62.5 

mg/kg/day show total litter loss, decreased live 

fetuses, increased early and late resorptions. 

Effects at 25 mg/kg/day show some 

malformations: hydrocephaly (4 fetuses from 

4 different litters, but NOT seen at 62.5 

mg/kg/day) and limb effects (2 fetuses from 2 

different litters, with one fetus with same 

effect at 62.5 mg/kg/d). Hydrocephaly and 

limb effects were observed at 10 mg/kg/day in 

Experiment #2, but not at that same dose in 

Experiment #1.

870.3800 Reproduction and 

fertility effects

2-generation- rat

46808447 (2002)

0, 30, 150 and 750 ppm 

M/F: 0/0, 2/2, 10.8/10.6, 

53.2/53.0 mg/kg/day

Acceptable/Guideline

Parental/Systemic NOAEL (M/F) = 9.8/10.8 

mg/kg/day

LOAEL (M/F) = 49.4/53.2 mg/kg/day based 

on: decreased body weight and decreased 

weight gain in male and female parental 

animals, increased incidence of fatty 

hepatocyte change in male parental animals, 

and increased incidence of spleen congestion 

in F1 parental females. 

Reproductive NOAEL (M/F) = 49.4/ 10.8 

mg/kg/day

LOAEL (M/F) = 53.2 mg/kg/day based on 

increased gestation length and decreased 

gestation index driven by dystocia (difficult 

labor).

Offspring NOAEL (M/F) = 9.8/10.8 

mg/kg/day

LOAEL (M/F) = 49.4/53.2 mg/kg/day based 

decreased viability on lactation day 0 and 

decreased body weight in F2 offspring. 

870.4100a Chronic toxicity 

rodents (rat)

4472109 (1992)

0, 10, 100, 300, 1000 ppm

M: 0, 0.44, 4.3, 13.1, 43.9 

mg/kg/day

F: 0, 0.52, 5.3, 16.0, 53.8 

mg/kg/day

Acceptable/Guideline

NOAEL = (M/F) = 4.3/16.0 mg/kg/day

LOAEL = (M/F) = 13.1/ 53.8 mg/kg/day 

based on an increase in mean adjusted liver 

weights at 12 months (M) and 24 months (F), 

increase in spleen weights at 24 months (F), 

and increased hepatocellular lipid vacuolation 

(M/F) and centrilobular hypertrophy (M/F).
Page 44 of 58

Table A.2.2. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1

Guideline 

No. 

Study Type MRID No. (year)/ 

Classification /Doses

Results

870.4100b Chronic toxicity- dog 44721610

0, 30, 300, 1000, 3000 ppm 

in diet

M: 0, 1.1, 12.0, 38.5, 110.0 

mg/kg/day

F: 0, 1.1, 10.3, 36.8, 113.7 

mg/kg/day

Acceptable/Guideline

NOAEL (M/F) = 12.0/10.3 mg/kg/day

LOAEL (M/F) = 38.5/36.8 mg/kg/day based 

on increased alkaline phosphatase activity 

(both sexes) and increased incidence of 

Kupffer cell pigmentation (females).

870.4200a Carcinogenicity -

rat

44721611 (1992)

0, 100, 300, 1000 ppm

M: 0, 4.6, 13.8, 46.5 

mg/kg/day

F: 0, 5.5, 16.6, 56.2 

mg/kg/day

Acceptable/Guideline

Non-neoplastic findings at (M/F) 13.8/56.2 

mg/kg/day: increased incidence of 

hepatocellular lipid vacuolation (M/F), 

centrilobular hypertrophy (M/F), liver pigment 

deposition (M), histiocytic foci in the spleen 

(M/F),and increase in severity of chronic 

renal nephropathy (M). Evidence of 

mononuclear cell leukemia (F).

870.4200b Carcinogenicitymouse44721612 (1992)

0, 30, 300, 1000 ppm

M: 0, 4.5, 39.5, 166.9 

mg/kg/day

F: 0, 5.9, 58.1, 195.5 

mg/kg/day

Acceptable/Guideline

Non-neoplastic findings at (M/F) 166.9/58.1 

mg/kg/day: increase in vacuolation, 

hypertrophy, splenic atrophy and adrenal 

corticomedullary pigmentation, sinusoidal 

hypercellularity/single cell necrosis. 

Neoplastic findings: increase in liver cell 

tumors at high dose (M/F): Increased 

incidence of hepatocellular adenomas in males 

and hepatocellular carcinomas in females. 

870.5100 Salmonella 

typhimurium and 

Escherichia coli

Reverse Mutation 

Assay

44721613 (1990)

Up to limit dose of 5000 

μg/ plate (S. typhimurium) 

and (E. coli) in the 

presence and absence of 

metabolic activation

(+ S9)

Acceptable/Guideline

Test material was not cytotoxic with or 

without S9 activation in five S. typhimurium

strains and one strain of E. coli, and did not 

induce a genotoxic response in any strain.

870.5300 In vitro Mouse 

Lymphoma 

Mutagenesis Assay

WL136184*

*cis only isomer

44721615 (1991)

Six doses up to 125 μg/ml 

(toxicity was observed 

above that dose) in the 

presence and absence of 

metabolic activation 

(+ S9)

Acceptable/Guideline

There was no evidence of biologically 

significant induction of mutant colonies. 

870.5375 In vitro Cytogenetics 

Test

44721616 (1991)

From 6.25 to 400 g/ml, 

with and without metabolic 

activation (+ S9) 

Acceptable/Guideline

Weakly positive (induced chromosome 

aberrations in Chinese hamster ovary cells) in 

the presence of S9 activation, negative without 

S9 activation. 
Page 45 of 58

Table A.2.2. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1

Guideline 

No. 

Study Type MRID No. (year)/ 

Classification /Doses

Results

870.5395 In vivo Mammalian 

Erythrocyte 

Micronucleus Test: 

Mouse

44721618 (1995)

Up to the limit dose of 2000 

mg/kg

Acceptable/Guideline

There was no statistically significant increase 

in the frequency of micronucleated 

polychromatic erythrocytes in mouse bone 

marrow at any dose or collection time.

870.5550 In vivo/in vitro

Mammalian UDS test

Rat

44721620 (1995)

Up to the limit dose of 2000 

mg/kg

Acceptable/Guideline

Negative for unscheduled DNA synthesis.

870.6200b Subchronic 

Neurotoxicity- rat

46808440 (2002)

0, 50, 170, 500 ppm

M: 0, 4.84, 15.69, 47.08 

mg/kg/day

F: 0, 5.10, 17.62, 49.82 

mg/kg/day

Acceptable/Non-guideline

Systemic NOAEL (M/F) = 4.84/5.10 mg/kg/

Systemic LOAEL (M/F) = 15.69/ 17.62 

mg/kg/ based on decreases in body weight and 

food consumption. 

Neurotoxicity NOAEL (M/F)  47.08/49.82 

mg/kg/day 

870.7485 Metabolism and 

pharmacokinetics: rat

44721622 (1992)

single high dose: 164 

mg/kg

Radiolabel: 

(cyclopentyl14C )

Acceptable/Guideline

Approximately 94% of radioactivity in excreta 

after five days: feces (males - 81.3%, females 

- 65.5%) and urine (males - 13.6%, females -

28.4%)

870.7485 Metabolism and 

pharmacokinetics: rat

44721623 (1991)

single low dose: 2 mg/kg

Radiolabel: 

(cyclopentyl14C)

Acceptable/Guideline

Approximately 94% of radioactivity in excreta 

after 72 hrs: feces (males - 80%, females -

67%) and urine (males - 14.8%, females -

26%). Metabolite information presented.

870.7485 Metabolism and 

pharmacokinetics: rat

WL136184*

*cis only isomer

44721624 (1991)

single high dose: 200 

mg/kg (males only)

Radiolabel: 

(Triazole -

14C)

Acceptable/Guideline

Approximately 96% of radioactivity in excreta 

after seven days: feces (76%) and urine (20%). 

Metabolite information presented.

870.7485 Metabolism and 

pharmacokinetics: rat

WL136184*

*cis only isomer

44721625 (1991)

single low dose: 2 mg/kg

Radiolabel: 

(Cyclopentyl -

14C)

Acceptable/Guideline

Excretion/retention in bile-duct cannulated 

rats. Approximately 80% of radioactivity was 

excreted in the bile after 48 hrs: males (78.7%) 

and females (83.3%). 

870.7485 Metabolism and 

pharmacokinetics: rat

46808449 (2002)

male/female rat

single low dose: 2 mg/kg

single high dose: 200 

mg/kg

repeated dose: 2 mg/kg

Acceptable/Non-guideline

Low potential for bioaccumulation following 

single or multiple dosing regimen. The time 

to maximum plasma concentration for male 

and female rats treated with either 2 mg/kg or 

200 mg/kg was the earliest sampling interval, 

0.25 hours and 4 hours, respectively The 

plasma half-life of low- and high-dose rats 

was slightly shorter in males than females, 

~20-25 hours and ~34 hours, respectively.
Page 46 of 58

Table A.2.2. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1

Guideline 

No. 

Study Type MRID No. (year)/ 

Classification /Doses

Results

870.7600 In Vivo Dermal 

Penetration Study

46808450 (1990)

Acceptable/Non-guideline

Dermal absorption= 16% (72 hrs)

870.7800 Immunotoxicity 

Study: male rat

48107301 (2010)

0, 70, 210, 6300 ppm

0, 5.4, 17, 52 mg/kg/day

Acceptable/Guideline

Systemic 

NOAEL: 52 mg/kg/day. 

LOAEL: > 52 mg/kg/day 

Immunotoxicity 

NOAEL: 52 mg/kg/day. 

LOAEL: > 52 mg/kg/day

NonguidelineEffects on rat/mice 

liver enzymes

WL136184*

*cis only isomer

44721626 (1991)

0, 300 ppm in diet (mice) 

and 0, 1000 ppm in diet 

(rats) for seven or 28 days 

Acceptable/Non-guideline

Increased liver weight, cytochrome P450, 

ethoxycoumarin O-deethylase, ethylmorphine 

N-demethylase, and lauric acid 11-

hydroxylase in both rats and mice. No effect 

on ethoxyresorufin O-deethylase, palmitoylCoA oxidation, or peroxisome proliferation (in 

terms of peroxisome number or morphology). 

Nonguideline14-day Mechanistic 

Study

46665403 (2004)

0, 30, 300, 1000 ppm in 

diet (mice) for 14 days.

F: 4.5, 48, 151 mg/kg/day

Acceptable/Non-guideline

Increased liver weight (300 and 1000 ppm); 

increased hepatic drug metabolizing enzymes 

(300 and 1000 ppm) after 7 days; enlarged 

livers (1000 ppm) at days 3, 7 and 14; hepatic 

hypertrophy and vacuolation (300 and 1000 

ppm) at day 14; increased ALT and AST 

activities at 1000 ppm (day 14); increased 

lipid peroxide (300 and 1000) at day 14; 

increased PCNA labeling at 1000 ppm at day 

3 and 7. 

1

cis/trans ratio is 85:15. All studies used cis/trans mixture unless otherwise noted.
Page 47 of 58

Appendix B. Physicochemical Properties of Metconazole.

Table B. Physicochemical Properties of Metconazole

Parameter Value References*

(MRID)

Melting point/range 100.0-108.4°C (using Electrothermal Digital Melting 

Point Apparatus) (AC900,768 technical grade)

44721505

pH 5.81 at 25oC (1% aqueous suspension) 46808402

Relative density (20°C) 1.14 (relative density to water at 4°C, using capillarystoppered, density-specific gravity bottle) (Lot No. AC 

8879-140B)

44721505

Water solubility (20oC) Using shake-flask method:

18.7 ± 1.0 mg/L (cis-isomer, WL148271, KNF-S-474m)

13.6 ± 1.7 mg/L (trans-isomer, WL148271, KNF-S-474m)

44721505

Solvent solubility (g/L) at 

20oC

Solvent Metconazole cis trans 44721505

acetone 363 251 117

methanol 403 294 117

dichloromethane 481 343 141

ethyl acetate 260 173 90.0

propanol 132 86.6 46.7

toluene 103 66.2 38.0

Hexane 1.40 0.929 0.483

Vapor pressure (20°C) Using gas-saturation method:

< 1.23x10-5Pa or 9.23 x 10-8 mm Hg (metconazole)

< 1.04x10-5Pa or 7.80 x 10-8 mm Hg (cis-isomer)

< 1.96x10-6Pa or 1.47 x 10-8 mm Hg (trans-isomer)

44721505

Dissociation constant (pKa) 11.38±0.03 and 1.06±0.03 (in water at 29.1°C using 

spectrophotometric method; Lot No. AC 8879-140B) 

44721505

Octanol/water partition 

coefficient, Log(KOW)

At 20 oC (using flask shaking method):

Kow (log Kow) = 7090±989 (3.85) (Lot No. AC 8879-

140B) (TGAI)

Kow (log Kow) = 7150±803 (3.85) (cis-isomer, CL 

354,801)

Kow (log Kow) = 6800±1700 (3.8) (trans-isomer, CL 

354,802)

44721505

UV/visible absorption 

spectrum

pH λ A log ε 46808403

cis-isomer

2.0 221.4 0.828 4.03

6.8 0.8452 4.04

7.0 0.9126 4.08

10.3 0.7226 3.98

trans-isomer

2.0 221.4 0.9053 4.07

7.0 0.9547 4.10

10.1 0.9893 4.11

* Product Chemistry Reviews: DP #256877, Shyam Mathur, Ph.D., 9/12/2000 and DP #329168, Shyam Mathur, 

Ph.D., 7/13/07.
Page 48 of 58

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 49 of 58

Appendix D. Residential Handler and Post-application Exposure and Risk Estimates

Table D.1. Residential Handler Non-cancer Exposure and Risk Estimates for Metconazole.

Exposure Scenario Formulation

Inhalation 

Unit Exposure 

(mg/lb ai)

Maximum Application 

Rate1

Area 

Treated 

or 

Amount 

Handled 

Daily2

Inhalation

Dose (mg/kg/day)3 MOE4

Mixer/Loader/Applicator

Manually Pressurized Handwand –

Gardens/Trees & Lawns/Turf

Liquid 0.018 0.00034 lb ai/gal 5 gal 0.00000038 3,900,000

Hose-End Sprayer – Gardens/Trees Liquid 0.0014 0.00034 lb ai/gal 11 gal 0.000000065 23,000,000

Backpack Sprayer – Gardens/Trees & 

Lawns/Turf

Liquid 0.14 0.00034 lb ai/gal 5 gal 0.0000030 500,000

Manually Pressurized Handwand – Lawns/Turf WDG 1.1 0.0034 lb ai/gal 5 gal 0.00024 6,300

Manually Pressurized Handwand –

Gardens/Trees

WDG 1.1 0.000014 lb ai/ft2

1200 ft20.00023 6,600

Hose-End Sprayer – Gardens/Trees WDG 0.0014 0.000014 lb ai/ft21200 ft20.00000029 5,200,000

Hose-End Sprayer- Lawns WDG 0.022 0.6 lb ai/A 0.5 acres 0.000083 18,000

Backpack Sprayer – Lawns/Turf WDG 1.1 0.0034 lb ai/gal 5 gal 0.00024 6,300

Backpack Sprayer – Gardens/Trees WDG 1.1 0.000014 lb ai/ft21200 ft20.00023 6,600

Push-Type Rotary Spreader – Lawns/Turf Granular 0.0026 0.6 lb ai/A 0.5 acres 0.0000096 160,000

Belly Grinder – Lawns/Turf Granular 0.039 0.000014 lb ai/ft21200 ft20.0000079 190,000

Spoon – Lawns/Turf Granular 0.087 0.000014 lb ai/ft2100 ft20.0000015 1,000,000

Cup – Gardens/Trees Granular 0.013 0.000014 lb ai/ft21200 ft20.0000026 570,000

Cup – Lawns/Turf Granular 0.013 0.000014 lb ai/ft2100 ft20.00000022 6,800,000

Hand Dispersal – Gardens/Trees Granular 0.38 0.000014 lb ai/ft21200 ft20.000077 19,000

Hand Dispersal – Lawns/Turf Granular 0.38 0.000014 lb ai/ft2100 ft20.0000064 230,000

Shaker Can – Gardens/Trees Granular 0.013 0.000014 lb ai/ft21200 ft20.0000026 570,000

Shaker Can – Lawns/Turf Granular 0.013 0.000014 lb ai/ft2100 ft20.00000022 6,800,000

1 Based on registered label (EPA Reg. Nos. 59639-182 (Liquid), 59639-181 (Granular), and 59639-144 (WDG)). 

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

3 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 (80 kg).

4 Inhalation MOE = Inhalation NOAEL (9.1 mg/kg/day) ÷ Inhalation Dose (mg/kg/day).
Page 50 of 58

Table D.2. Residential Post-application Non-cancer Exposure and Risk Estimates for Metconazole.

Lifestage

Post-application Exposure 

Scenario Formulation Application 

Rate1

Dose 

(mg/kg/day)2 MOEs3

Use Site Route of 

Exposure

Short-Term

Child Lawns/Turf

Object to 

Mouth Granular

0.6 lb ai/A

0.000055 160,000

Hand to Mouth Granular 0.00091 10,000

Soil Ingestion Granular 0.000020 450,000

Object to 

Mouth WDG

0.6 lb ai/A

0.00028 33,000

Hand to Mouth WDG 0.0091 1,000

Soil Ingestion WDG 0.000020 450,000

1 Based on registered labels (Reg. Nos. 59639-181 (Granular) and 59639-144 (WDG)).

2 Dose (mg/kg/day) equations provided in 2012 Residential SOPs (http://www.epa gov/pesticides/science/residential-exposuresop.html)

3 MOE = POD (9.1 mg/kg/day) ÷ Dose (mg/kg/day).
Page 51 of 58

Appendix E. Occupational Handler Exposure and Risk Estimates

Table E.1. Short-Term Occupational Handler Non-Cancer Exposure and Risk Estimates for Metconazole.

Exposure Scenario Crop or Target Level of 

Concern

Inhalation Unit 

Exposure (μg/lb ai)1

Maximum

Application 

Rate2

Area Treated or 

Amount Handled 

Daily3

Inhalation

[Mitigation] Dose (mg/kg/day)4 MOE5

Mixer/Loader

Mixing/Loading WDG for 

Aerial Application

Stone Fruits (Crop Group 12-12)

1000

8.96

[baseline, no 

respirator]

0.125 lb ai/A 350 acres 0.0049 1,900

Tree Nuts (Crop Group 14-12) 0.11 lb ai/A 350 acres 0.0043 2,100

Canola (Crop Subgroup 20A), 

Sunflower (Crop Subgroup 20B), 

Dry Beans and Peas (Crop 

Subgroup 6C)

0.125 lb ai/A 1200 acres

0.017 540

1.792

[PF5 respirator] 0.0034 2,700

Mixing/Loading WDG for 

Airblast Application

Stone Fruits (Crop Group 12-12)

8.96

[baseline, no 

respirator]

0.125 lb ai/A

40 acres

0.00056 16,000

Tree Nuts (Crop Group 14-12) 0.11 lb ai/A 0.00049 18,000

Mixing/Loading WDG for 

Chemigation Application

Stone Fruits (Crop Group 12-12) 0.125 lb ai/A

350 acres

0.0049 1,900

Tree Nuts (Crop Group 14-12) 0.11 lb ai/A 0.0043 2,100

Canola (Crop Subgroup 20A), 

Sunflower (Crop Subgroup 20B), 

Dry Beans and Peas (Crop 

Subgroup 6C)

0.125 lb ai/A 0.0049 1,900

Groundbooom

Canola (Crop Subgroup 20A), 

Sunflower (Crop Subgroup 20B), 

Dry Beans and Peas (Crop 

Subgroup 6C)

0.125 lb ai/A 200 acres 0.0028 3,300

Applicator

Aerial Application

Stone Fruits (Crop Group 12-12)

1000

0.0049

[baseline, no 

respirator]

0.125 lb ai/A

350 acres

0.0000027 3,400,000

Tree Nuts (Crop Group 14-12) 0.11 lb ai/A 0.0000024 3,900,000

Canola (Crop Subgroup 20A), 

Sunflower (Crop Subgroup 20B), 

Dry Beans and Peas (Crop 

Subgroup 6C)

0.125 lb ai/A 1200 acres 0.0000092 990,000

Airblast Application

Stone Fruits (Crop Group 12-12) 4.71

[baseline, no 

respirator]

0.125 lb ai/A

40 acres

0.00030 31,000

Tree Nuts (Crop Group 14-12) 0.11 lb ai/A 0.00026 35,000

Groundboom Application Canola (Crop Subgroup 20A), 

Sunflower (Crop Subgroup 20B), 

0.34

[baseline, no 

0.125 lb ai/A 200 acres 0.00011 86,000
Page 52 of 58

Table E.1. Short-Term Occupational Handler Non-Cancer Exposure and Risk Estimates for Metconazole.

Exposure Scenario Crop or Target Level of 

Concern

Inhalation Unit 

Exposure (μg/lb ai)1

Maximum

Application 

Rate2

Area Treated or 

Amount Handled 

Daily3

Inhalation

[Mitigation] Dose (mg/kg/day)4 MOE5

Dry Beans and Peas (Crop 

Subgroup 6C)

respirator]

Flagger

Flagging for Aerial Application

Stone Fruits (Crop Group 12-12)

1000

0.35

[baseline, no 

respirator]

0.125 lb ai/A

350 acres

0.00019 48,000

Tree Nuts (Crop Group 14-12) 0.11 lb ai/A 0.00017 54,000

Canola (Crop Subgroup 20A), 

Sunflower (Crop Subgroup 20B), 

Dry Beans and Peas (Crop 

Subgroup 6C)

0.125 lb ai/A 0.00019 48,000

Mixer/Loader/Applicator

Mixing/Loading/Applying with 

a Mechanically Pressurized 

Handgun

Stone Fruits (Crop Group 12-12)

1000

3.9

[baseline, no 

respirator]

0.00125 lb ai/gal

1000 gallons

0.000061 150,000

Tree Nuts (Crop Group 14-12) 0.0011 lb ai/gal 0.000054 170,000

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table”; Level of mitigation: Baseline, PPE, Eng. Controls. Aerial applicators = Eng. Controls, all other estimates 

are baseline PPE.

2 Based on proposed label (Reg. No. 59639-147).

3 Exposure Science Advisory Council Policy #9.1.

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 (80 kg).

7 Inhalation MOE = Inhalation NOAEL (9.1 mg/kg/day) ÷ Inhalation Dose (mg/kg/day).
Page 53 of 58

Table E.2. Intermediate-Term Occupational Handler Non-Cancer Exposure and Risk Estimates for Metconazole.

Exposure Scenario Crop or Target Level of 

Concern

Inhalation Unit 

Exposure (μg/lb ai)1

Maximum

Application 

Rate2

Area Treated or 

Amount Handled 

Daily3

Inhalation

[Mitigation] Dose (mg/kg/day)6 MOE7

Mixer/Loader

Mixing/Loading WDG for 

Aerial Application

Stone Fruits (Crop Group 12-12)

1000

8.96

[baseline, no 

respirator]

0.125 lb ai/A 350 acres 0.0049 1,300

Tree Nuts (Crop Group 14-12) 0.11 lb ai/A 350 acres 0.0043 1,500

Canola (Crop Subgroup 20A), 

Sunflower (Crop Subgroup 20B), 

Dry Beans and Peas (Crop 

Subgroup 6C)

0.125 lb ai/A 1200 acres

0.017 380

1.792 

[PF5 respirator] 0.0034 1,900

Mixing/Loading WDG for 

Airblast Application

Stone Fruits (Crop Group 12-12)

8.96

[baseline, no 

respirator]

0.125 lb ai/A

40 acres

0.00056 11,000

Tree Nuts (Crop Group 14-12) 0.11 lb ai/A 0.00049 13,000

Mixing/Loading WDG for 

Chemigation Application

Stone Fruits (Crop Group 12-12) 0.125 lb ai/A

350 acres

0.0049 1,300

Tree Nuts (Crop Group 14-12) 0.11 lb ai/A 0.0043 1,500

Canola (Crop Subgroup 20A), 

Sunflower (Crop Subgroup 20B), 

Dry Beans and Peas (Crop 

Subgroup 6C)

0.125 lb ai/A

0.0049 1,300

Mixing/Loading WDG for 

Groundboom Application

Canola (Crop Subgroup 20A), 

Sunflower (Crop Subgroup 20B), 

Dry Beans and Peas (Crop 

Subgroup 6C)

200 acres 0.0028 2,300

Applicator

Aerial Application

Stone Fruits (Crop Group 12-12)

1000

0.0049

[baseline, no 

respirator]

0.125 lb ai/A

350 acres

0.0000027 2,400,000

Tree Nuts (Crop Group 14-12) 0.11 lb ai/A 0.0000024 2,700,000

Canola (Crop Subgroup 20A), 

Sunflower (Crop Subgroup 20B), 

Dry Beans and Peas (Crop 

Subgroup 6C)

0.125 lb ai/A 1200 acres 0.0000092 700,000

Airblast Application

Stone Fruits (Crop Group 12-12) 4.71

[baseline, no 

respirator]

0.125 lb ai/A

40 acres

0.00030 22,000

Tree Nuts (Crop Group 14-12) 0.11 lb ai/A 0.00026 25,000

Groundboom Application

Canola (Crop Subgroup 20A), 

Sunflower (Crop Subgroup 20B), 

Dry Beans and Peas (Crop 

0.34

[baseline, no 

respirator]

0.125 lb ai/A 200 acres 0.00011 60,000
Page 54 of 58

Table E.2. Intermediate-Term Occupational Handler Non-Cancer Exposure and Risk Estimates for Metconazole.

Exposure Scenario Crop or Target Level of 

Concern

Inhalation Unit 

Exposure (μg/lb ai)1

Maximum

Application 

Rate2

Area Treated or 

Amount Handled 

Daily3

Inhalation

[Mitigation] Dose (mg/kg/day)6 MOE7

Subgroup 6C)

Flagger

Flagging for Aerial Application

Stone Fruits (Crop Group 12-12)

1000

0.35

[baseline, no 

respirator]

0.125 lb ai/A

350 acres

0.00019 34,000

Tree Nuts (Crop Group 14-12) 0.11 lb ai/A 0.00017 38,000

Canola (Crop Subgroup 20A), 

Sunflower (Crop Subgroup 20B), 

Dry Beans and Peas (Crop 

Subgroup 6C)

0.125 lb ai/A 0.00019 34,000

Mixer/Loader/Applicator

Mixing/Loading/Applying with 

a Mechanically Pressurized 

Handgun

Stone Fruits (Crop Group 12-12)

1000

3.9

[baseline, no 

respirator]

0.00125 lb ai/gal

1000 gallons

0.000061 100,000

Tree Nuts (Crop Group 14-12) 0.0011 lb ai/gal 0.000054 100,000

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table”; Level of mitigation: Baseline, PPE, Eng. Controls. Aerial applicators = Eng. Controls, all other estimates 

are baseline PPE.

2 Based on proposed label (Reg. No. 59639-147).

3 Exposure Science Advisory Council Policy #9.1.

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 (80 kg).

7 Inhalation MOE = Inhalation NOAEL (6.4 mg/kg/day) ÷ Inhalation Dose (mg/kg/day).
Page 55 of 58

Appendix F. Summaries of Field Residue Data

Table F.1. Summary of Residues from Field Trials with Metconazole.

Crop 

Matrix

Analyte Total 

Application 

Rate

(lb ai/A)

PHI 

(days)

n

1 Residues (ppm)

Min.2 Max.2 LAFT3 HAFT3 Median3 Mean3SD3

BEAN, DRY (Proposed Use = 0.25 lb ai/acre total application rate, 21-day PHI)

Bean, dry Metconazole (sum of 

cis- and trans-isomers)

0.245-0.259 19-23 13 <0.04 <0.04 <0.04 <0.04 0.04 0.04 N/A

TA 0.245-0.259 19-23 13 <0.02 0.348 <0.02 0.346 0.021 0.048 0.090

PEA, DRY (Proposed Use = 0.25 lb ai/acre total application rate, 21-day PHI)

Pea, dry Metconazole (sum of 

cis- and trans-isomers)

0.250-0.258 20-22 5 <0.04 <0.0620 <0.04 <0.0562 0.040 0.043 0.007

Pea, dry TA 0.250-0.258 20-22 5 0.155 3.16 0.187 2.38 0.591 0.864 0.869

SUNFLOWER (Proposed Use = 0.25 lb ai/acre total application rate, 21-day PHI)

Sunflower 

seed

Metconazole (sum of 

cis- and trans-isomers)

0.245-0.259 20-21 10 <0.04 0.968 <0.04 0.440 0.067 0.127 0.131

Sunflower 

seed

TA 0.245-0.259 20-21 10 <0.02 0.252 <0.02 0.148 0.049 0.054 0.039

1

n = number of field trials.

2 Values based on total number of samples.

3 Values based on per-trial averages. LAFT = lowest average field trial, HAFT = highest average field trial, SD = standard 

deviation. For computation of the LAFT, HAFT, median, mean, and standard deviation, values <LOQ are assumed to be at the 

LOQ (0.04 ppm for total metconazole and 0.02 ppm for TA). N/A = Not applicable.

Table F.2. Summary of Residue Data from Crop Field Trials with Metconazole (WDG).

Crop matrix Total Applic. 

Rate (lb ai/A)

PHI 

(days)

Residue Levels (ppm) 1

n Min. Max. HAFT 2 Median Mean Std. Dev.

Canola (proposed use = 0.125 lb ai/A total application rate, 35-day PHI)

Canola seed

0.124-0.130 35-49 14 <0.04 <0.04 <0.04 0.04 0.04 NA

0.245-0.250 37-49 4 <0.04 <0.04 <0.04 0.04 0.04 NA

0.632 35 3 <0.04 <0.04 <0.04 0.04 0.04 NA

1 The LOQ is 0.02 ppm for each isomer, for a combined LOQ of 0.04 ppm. For calculation of the median, mean, and standard 

deviation, the LOQ was used for samples with residues <LOQ.

2 HAFT = Highest Average Field Trial.

Table F.3. Summary of Residue Data for the Triazole Metabolites from Canola Field Trials with 

Metconazole (WDG).

Commodity Total 

Applic. Rate

(lb ai/A)

PHI 

(days) Analyte

Residue Levels (ppm) 1

n 2 Min. Max. HAFT 3 Median Mean Std. Dev.

Canola (proposed use = 0.125 lb ai/A total application rate, 35-day PHI)

Canola seed 0.124-0.130 35-49

1,2,4-T 6 <0.01 <0.01 <0.01 0.01 0.01 NA

TA 46 0.18 0.50 0.49 0.28 0.31 0.14

TAA 6 <0.01 <0.01 <0.01 0.01 0.01 NA

1 The LOQ is 0.01 ppm for each triazole analyte. For calculation of the median, mean, and standard deviation, the LOQ was 

used for samples with residues <LOQ. 

2

For triazole analysis, seed samples were pooled by growing region to yield 3 pooled samples that were each analyzed in 

duplicate. Seeds from Trial F were not included in the pool samples as they were not of commercial quality.

3 HAFT = highest average residues from pooled regional samples.

4 TA residues were found in all control samples at 0.22-0.27 ppm and averaged 0.24 ppm.
Page 56 of 58

Table F.4. Summary of Residue Data from Stone Fruit Crop Field Trials with Metconazole

Crop 

matrix

Total Applic. 

Rate

(lb ai/A)

PHI

(days)

Analyte Residue Levels (ppm)1

n Min. Max. HAFT2 Median Mean Std. 

Dev.

STONE FRUIT (proposed use = 0.375 lb ai/A total application rate, 14-day PHI)

1.81 lb/gal FlC formulation

Cherry 0.405-0.416

0.538

(1 trial)

13-14 cis-Metconazole 16 <0.02 0.134 0.119 0.041 0.048 0.032

trans-Metconazole 16 <0.02 0.028 0.025 0.020 0.021 0.002

Metconazole 16 <0.04 0.162 0.143 0.061 0.068 0.033

Peach 0.403-0.417

0.545

(1 trial)

13-14 cis-Metconazole 18 <0.020 0.073 0.066 0.027 0.030 0.015

trans-Metconazole 18 <0.020 <0.020 0.020 <0.020 <0.020 0.00

Metconazole 18 <0.040 <0.093 0.086 0.047 0.050 0.015

Plum 0.405-0.412

0.538

(1 trial)

13-14 cis-Metconazole 12 <0.020 0.04 0.06 0.020 0.024 0.008

trans-Metconazole 12 <0.020 <0.020 <0.020 <0.020 <0.020 --

Metconazole 12 <0.040 <0.060 0.060 0.040 0.044 0.008

50% WDG formulation

Cherry 0.407-0.410 14 cis-Metconazole 4 0.027 0.056 0.052 0.039 0.040 0.014

trans-Metconazole 4 <0.02 <0.02 0.02 0.020 0.020 0.020

Metconazole 4 0.049 <0.076 0.076 0.068 0.065 0.011

Peach 0.418 14 cis-Metconazole 2 <0.02 0.020 0.02 0.02 0.02 --

trans-Metconazole 2 <0.02 <0.02 0.02 0.02 0.02 --

Metconazole 2 <0.04 <0.040 0.04 0.04 0.04 --

Plum 0.408 14 cis-Metconazole 2 <0.02 0.020 0.02 0.02 0.02 --

trans-Metconazole 2 <0.02 <0.02 0.02 0.02 0.02 --

Metconazole 2 <0.04 <0.040 0.04 0.04 0.04 --

1 Values for “Metconazole” and “Total Residues” are reported on a sample basis and are therefore not summations 

of tabulated data.

2 HAFT = Highest average field trial result.

Table F.5. Summary of Residue Data from Tree Nut Crop Field Trials with Metconazole1

Crop 

matrix

Total 

Applic. Rate

(lb ai/A)

PHI

(days)

Analyte Residue Levels (ppm)

n Min. Max. HAFT2 Median Mean Std. 

Dev.

TREE NUTS (proposed use = 0.44 or 0.50 lb ai/A total application rate, 25-day PHI)

1.81 lb/gal FlC formulation

Almond, 

hulls

0.543-0.570 25 cis-Metconazole 10 0.42 3.04 2.49 0.65 1.05 0.84

trans-Metconazole 10 0.08 0.65 0.50 0.13 0.22 0.19

Metconazole 10 0.50 3.69 2.82 0.78 1.27 1.03

0.394-0.408 25 cis-Metconazole 4 0.30 0.62 0.62 0.48 0.47 0.17

trans-Metconazole 4 0.07 0.15 0.14 0.11 0.11 0.04

Metconazole 4 0.37 0.76 0.76 0.59 0.58 0.21
Page 57 of 58

Table F.5. Summary of Residue Data from Tree Nut Crop Field Trials with Metconazole1

Crop 

matrix

Total 

Applic. Rate

(lb ai/A)

PHI

(days)

Analyte Residue Levels (ppm)

n Min. Max. HAFT2 Median Mean Std. 

Dev.

Almond, 

nutmeat

0.543-0.570 25 cis-Metconazole 10 <0.02 <0.02 <0.02 0.02 0.02 --

trans-Metconazole 10 <0.02 <0.02 <0.02 0.02 0.02 --

Metconazole 10 <0.04 <0.04 <0.04 0.04 0.04 --

0.394-0.408 25 cis-Metconazole 4 <0.02 <0.02 <0.02 0.02 0.02 --

trans-Metconazole 4 <0.02 <0.02 <0.02 0.02 0.02 --

Metconazole 4 <0.04 <0.04 <0.04 0.04 0.04 --

Pecan,

nutmeat

0.502-0.537 25-32 cis-Metconazole 4 <0.02 <0.02 <0.02 0.02 0.02 --

trans-Metconazole 4 <0.02 <0.02 <0.02 0.02 0.02 --

Metconazole 6 <0.04 <0.04 <0.04 0.04 0.04 --

50% WDG formulation

Almond, 

hulls

0.402-0.407 25 cis-Metconazole 4 <0.02 1.69 1.51 0.68 0.77 0.87

trans-Metconazole 4 <0.02 0.33 0.31 0.15 0.16 0.17

Metconazole 4 <0.04 2.02 1.82 0.83 0.93 1.04

Almond, 

nutmeat

0.402-0.407 25 cis-Metconazole 4 <0.02 <0.02 <0.02 0.02 0.02 --

trans-Metconazole 4 <0.02 <0.02 <0.02 0.02 0.02 --

Metconazole 4 <0.04 <0.04 <0.04 0.04 0.04 --

Pecan,

nutmeat

0.529 26 cis-Metconazole 2 <0.02 <0.02 <0.02 0.02 0.02 --

trans-Metconazole 2 <0.02 <0.02 <0.02 0.02 0.02 --

Metconazole 2 <0.04 <0.04 <0.04 0.04 0.04 --

1

Values for “Metconazole” and “Total Residues” are reported on a sample basis and are therefore not summations 

of tabulated data.

2 HAFT = Highest average field trial result.
Page 58 of 58

Appendix G. International Residue Limits Status Sheet

Metconazole (125619; 08/27/2014)

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US Canada Mexico2 Codex

40 CFR §180.617

Metconazole [5-[(4-

chlorophenyl)methyl]-2,2-dimethyl1-(1H-1,2,4-triazol-1-

ylmethyl)cyclopentanol]

5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1H1,2,4-triazol-1-ylmethyl) cyclopentanolNone

Commodity1

Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico

2

Codex

Fruit, stone, group 12-12 0.2

0.2 American plums, apricots, beach plums, black

cherries, Canada plums, capulins, cherry plums, 

chicksaw plums, damson plums, fresh prune plums, 

Japanese apricots, Japanese plums, klamath plums, 

nanking cherries, nectarines, peaches, plumcots, 

plums, sloes, sweet cherries, tart cherries

Nut, tree, group 14-12 0.04

0.04 African tree nuts, almond nuts, beechnuts, 

black walnuts, Brazil nuts, Brazilian pine nuts, 

bunya nuts, bur oak nuts, butternuts, Cajou nuts, 

candlenuts, cashew nuts, chestnuts, chinquapin nuts, 

coconuts, coquito nuts, dika nuts, English walnuts, 

ginkgo nuts, Guiana chestnuts, hazelnuts (filbert), 

heartnuts, hickory nuts, Japanese horse-chestnuts, 

macadamia nuts, mongongo nuts, monkey-pot nuts, 

monkey puzzle nuts, Okari nuts, Pachira nuts, peach 

palm nuts, peanuts, pecan nuts, pequi nuts, Pili nuts, 

pine nuts, pistachio nuts, Sapucaia nuts, tropical 

almond nuts, yellow horn nuts

Pea and bean, dried shelled,

except soybean, subgroup

6C

0.15

0.15 Dry (adzuki beans, beans, blackeyed peas, 

broad beans, catjang seeds, chickpeas, cowpea 

seeds, field peas, guar seeds, kidney beans, lablab 

beans, lentils, lima beans, moth beans, mung beans, 

navy beans, pigeon peas, pink beans, pinto beans, 

rice beans, southern peas, tepary beans, urd beans, 

grain lupin

0.05 dry soybeans

Rapeseed subgroup 20A 0.08

0.08 Seeds (borage, cuphea, echium, flax, gold of 

pleasure, hare's ear mustard, milkweed, mustard 

(oilseed type), oil radish, poppy, rapeseed (canola), 

sesame, sweet rocket 

Sunflower subgroup 20B 0.7

Completed: M. Negussie; 08/27/2014

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.