United States Prevention, Pesticides EPA 738-R-06-003 

 Environmental Protection And Toxic Substances August 2006 

 Agency (7508P)

 _________________________________________________________________

Reregistration Eligibility 

Decision for 

Triadimefon 

 

And 

Tolerance 

Reassessment for 

Triadimenol 

List B 

Case No. 2700 

TABLE OF CONTENTS

Triadimefon Reregistration Eligibility Decision Team .............................................................. i 

Glossary of Terms and Abbreviations ........................................................................................ ii 

ABSTRACT................................................................................................................................... 1 

I. Introduction....................................................................................................................... 1

II. Chemical Overview........................................................................................................... 3 

A. Regulatory History............................................................................................................ 3 

B. Chemical Identification .................................................................................................... 4 

 1. Technical Triadimefon ..................................................................................................... 4 

 2. Triadimenol ....................................................................................................................... 5

 3. Triazole Metabolites......................................................................................................... 5 

 a. 1,2,4-Triazole .............................................................................................................. 6 

 b. Triazole Alanine......................................................................................................... 6 

 c. Triazole Acetic Acid.................................................................................................. 6 

C. Use Profile......................................................................................................................... 7 

 1. Triadimefon....................................................................................................................... 7

 2. Triadimenol....................................................................................................................... 8

D. Estimated Usage of Pesticide........................................................................................... 9 

 1. Triadimefon...................................................................................................................... 9

 2. Triadimenol ...................................................................................................................... 9

III. Summary of Risk Assessments ...................................................................................... 9 

A. Human Health Risk Assessment.................................................................................. 10 

1. Toxicity of Triadimefon and Triadimenol................................................................. 11 

 a. Acute Toxicity Profile............................................................................................ 11 

 b. FQPA Special Safety Factor Considerations ...................................................... 13 

 c. Toxicological Endpoints......................................................................................... 13 

2. Carcinogenicity ............................................................................................................ 15 

3. Endocrine Effects......................................................................................................... 16 

4. Dietary Exposure and Risk ......................................................................................... 16 

 a. Dietary (Food) Risk Assessment........................................................................... 17 

 1) Acute Dietary Food Risk................................................................................... 17 

 2) Chronic Dietary Food Risk............................................................................... 18 

 b. Dietary Exposure from Drinking Water ............................................................. 19 

 c. Dietary Risk from Drinking Water ...................................................................... 20 

 1) Acute Dietary Water Risk................................................................................. 20 

 2) Chronic Dietary Water Risk............................................................................. 21

5. Residential (Non-dietary) Exposure and Risk........................................................... 22 

 a. Residential Handler Risk ...................................................................................... 22 

 b. Residential Post-application Exposure and Risks .............................................. 24

6. Aggregate Exposure/Risk from Triadimefon and Triadimenol.............................. 25

7. Pesticide and Pharmaceutical Co-Exposure Assessment for the Triazole 

 Metabolites................................................................................................................... 28 

8. Cumulative Risk Assessment...................................................................................... 29 

9. Occupational Risk........................................................................................................ 29 
 a. Occupational Toxicity............................................................................................. 30

 b. Occupational Handler Exposure........................................................................... 31 

 c. Occupational Handler Risk Summary.................................................................. 32 

 d. Occupational Post-application Risk Summary.................................................... 37 

10. Human Incident Data .................................................................................................. 37 

B. Environmental Fate and Effects Risk Assessment.................................................... 38 

1. Environmental Fate and Transport........................................................................... 39 

2. Ecological Exposure and Risk..................................................................................... 39 

 a. Aquatic Organism Exposure and Risk ................................................................. 40

 1) Fish, Invertebrate, and Aquatic Plant Toxicity ............................................. 40 

 2) Fish and Invertebrate Exposure...................................................................... 42

 3) Fish and Invertebrate Risk .............................................................................. 43 

 4) Non-target Aquatic Plants............................................................................... 43 

 b. Terrestrial Organism Exposure and Risk........................................................... 44 

 1) Bird and Mammal Toxicity ............................................................................. 44 

 2) Bird and Mammal Exposure ........................................................................... 46 

 3) Bird and Mammal Risk.................................................................................... 46 

 4) Non-target Terrestrial Plants.......................................................................... 48 

 5) Non-target Insects............................................................................................. 49 

 3. Ecological Incidents..................................................................................................... 49 

4. Endangered Species........................................................................................................... 49

IV. Risk Management, Reregistration, and Tolerance Reassessment Decision ........... 49 

A. Determination of Reregistration Eligibility and Tolerance Reassessment............. 49 

B. Public Comments and Responses............................................................................... 50 

C. Regulatory Position under the FFDCA...................................................................... 50 

1. Food Quality Protection Act Findings....................................................................... 50 

 a. “Risk Cup” Determination..................................................................................... 50 

 b. Determination of Safety to U.S. Population ........................................................ 51 

 c. Determination of Safety to Infants and Children................................................ 51 

 d. Endocrine Disruptor Effects................................................................................. 51 

 e. Cumulative Risks................................................................................................... 52 

 2. Tolerance Summary for Triadimefon........................................................................ 52 

 a. Tolerances Currently Listed Under 40 CFR §180.410....................................... 52 

 b. Codex Harmonization ........................................................................................... 55 

 c. Residue Analytical Methods – Plants/Livestock ................................................. 55 

 3. Tolerance Summary for Triadimenol....................................................................... 56

 a. Tolerances Currently Listed Under 40 CFR §180.450........................................ 56

D. Regulatory Rationale................................................................................................... 58 

1. Human Health Risk Management.............................................................................. 59 

 a. Dietary (Food and Water) Risk Mitigation ......................................................... 59 

 b. Residential Risk Mitigation .................................................................................. 59 

 c. Occupational Risk Mitigation............................................................................... 60 

 d. Aggregate Risk Mitigation for Triazole Metabolites.......................................... 61 

 2. Environmental Risk Mitigation.................................................................................. 61 

 3. Other Labeling ............................................................................................................. 61
 4. Endangered Species Program..................................................................................... 61

V. What Registrants Need to Do..................................................................................... 62 

A. Manufacturing Use Products..................................................................................... 64 

 1. Generic Data Requirements for Triadimefon.......................................................... 64 

 2. Labeling for Manufacturing Use Products............................................................... 65 

B. End-Use Products........................................................................................................ 65 

 1. Additional Product-Specific Data Requirements..................................................... 65 

 2. Labeling for End-Use Products................................................................................. 65 

C. Data Requirements for Triadimenol......................................................................... 65

D. Labeling Changes Summary Table ........................................................................... 66 

VI. Appendices................................................................................................................... 79 

 A. Use Patterns Subject to Reregistration for Triadimefon ........................................ 83 

 B. Table of Generic Data Requirements and Studies Used to Make the 

 Reregistration Decision .............................................................................................. 83 

 C. Technical Support Documents................................................................................... 94 

D. Citations Considered to be Part of the Data Base Supporting the Reregistration 

 Eligibility Decision (Bibliography) for Triadimefon and Triadimenol.................. 97 

E. Generic Data Call-In................................................................................................ 114 

F. Product Specific Data Call-In.................................................................................. 116 

G. Batching of Triadimenol/Triadimefon Products .................................................. 118 

H. List of Registrants Sent this Data Call-In.............................................................. 122

 I. List of Available Related Documents and Electronically Available Forms....... 123 

 

 
i

Triadimefon Reregistration Eligibility Decision Team

Office of Pesticide Programs: 

Biological and Economic Analysis Assessment

Andrew Lee 

Jenna Carter 

Jin Kim 

Tara Chandgoyal 

Environmental Fate and Effects Risk Assessment

Michelle Embry 

Jonathan Angier 

Fred Jenkins 

Dana Spatz 

Health Effects Risk Assessment

Samuel Ary 

Judy Facey 

Shanna Recore 

Richard Griffin 

Michael Doherty 

Alan Nielsen 

Sheila Piper 

Yvonne Barnes 

Registration Support

Tony Kish 

Risk Management

John W. Pates, Jr. 

Kelly Sherman 

Veronique LaCapra 

Office of General Counsel

Erin Koch 
ii

Glossary of Terms and Abbreviations

AGDCI Agricultural Data Call-In 

ai Active Ingredient 

aPAD Acute Population Adjusted Dose 

AR Anticipated Residue 

BCF Bioconcentration Factor 

CFR Code of Federal Regulations 

cPAD Chronic Population Adjusted Dose 

CSF Confidential Statement of Formula 

CSFII USDA Continuing Surveys for Food Intake by Individuals 

DCI Data Call-In 

DEEM Dietary Exposure Evaluation Model 

DFR Dislodgeable Foliar Residue 

DWLOC Drinking Water Level of Comparison. 

EC Emulsifiable Concentrate Formulation 

EEC Estimated Environmental Concentration 

EPA Environmental Protection Agency 

EUP End-Use Product 

FDA Food and Drug Administration 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FFDCA Federal Food, Drug, and Cosmetic Act 

FQPA Food Quality Protection Act 

FOB Functional Observation Battery 

G Granular Formulation 

GENEEC Tier I Surface Water Computer Model 

GLN Guideline Number 

HAFT Highest Average Field Trial 

IR Index Reservoir 

LC50 Median Lethal Concentration. A statistically derived concentration of 

a substance that can be expected to cause death in 50% of test animals. 

It is usually expressed as the weight of substance per weight or volume 

of water, air or feed, e.g., mg/l, mg/kg or ppm. 

LD50 Median Lethal Dose. A statistically derived single dose that can be 

expected to cause death in 50% of the test animals when administered 

by the route indicated (oral, dermal, inhalation). It is expressed as a 

weight of substance per unit weight of animal, e.g., mg/kg. 

LOC Level of Concern 

LOD Limit of Detection 

LOAEL Lowest Observed Adverse Effect Level 

MATC Maximum Acceptable Toxicant Concentration 

Fg/g Micrograms Per Gram 

Fg/L Micrograms Per Liter 

mg/kg/day Milligram Per Kilogram Per Day 

mg/L Milligrams Per Liter 

MOE Margin of Exposure 
iii

MRID Master Record Identification (number). EPA's system of recording 

and tracking studies submitted. 

MUP Manufacturing-Use Product 

NA Not Applicable 

NAWQA USGS National Water Quality Assessment 

NPDES National Pollutant Discharge Elimination System 

NR Not Required 

NOAEL No Observed Adverse Effect Level 

OP Organophosphate 

OPP EPA Office of Pesticide Programs 

OPPTS EPA Office of Prevention, Pesticides and Toxic Substances 

PAD Population Adjusted Dose 

PCA Percent Crop Area 

PDP USDA Pesticide Data Program 

PHED Pesticide Handler's Exposure Data 

PHI Preharvest Interval 

ppb Parts Per Billion 

PPE Personal Protective Equipment 

ppm Parts Per Million 

PRZM/EXAMS Tier II Surface Water Computer Model 

Q1* The Carcinogenic Potential of a Compound, Quantified by the EPA's 

Cancer Risk Model 

RAC Raw Agriculture Commodity 

RED Reregistration Eligibility Decision 

REI Restricted Entry Interval 

RfD Reference Dose 

RQ Risk Quotient 

SCI-GROW Tier I Ground Water Computer Model 

SAP Science Advisory Panel 

SF Safety Factor 

SLC Single Layer Clothing 

SLN Special Local Need (Registrations Under Section 24(c) of FIFRA) 

TGAI Technical Grade Active Ingredient 

TRR Total Radioactive Residue 

USDA United States Department of Agriculture 

USGS United States Geological Survey 

UF Uncertainty Factor 

UV Ultraviolet 

WPS Worker Protection Standard 
1

ABSTRACT 

 The Environmental Protection Agency (EPA or the Agency) has completed the 

human health and environmental risk assessments for triadimefon and the dietary and 

aggregate assessments for triadimenol, and is issuing its risk management reregistration 

decision and tolerance reassessment. The risk assessments, which are summarized below, 

are based on the review of the required target database supporting the use patterns of 

currently supported products and additional information received through the public docket. 

 The Agency discussed the dietary risks of concern (food + water) with the registrant, 

and the registrant has proposed a number of changes to its triadimefon registration including 

the voluntary deletion of all food (except pineapples) and residential turf use, and a reduction 

of application rates and frequencies. In doing so, this document has estimated exposure and 

risk based on these new use patterns. 

 After considering the risks identified in the revised risk assessments, comments 

received, and mitigation suggestions from interested parties, the Agency developed its risk 

management reregistration decision for uses of triadimefon and tolerance reassessment for 

triadimenol. As a result of this review, EPA has determined that triadimefon-containing 

products are eligible for reregistration, provided that risk mitigation measures are adopted 

and labels are amended accordingly. Furthermore, the tolerances for triadimefon and 

triadimenol are considered reassessed and regulatory action under the Federal Food, Drug 

and Cosmetic Act (“FFDCA”) will occur after the uses that do not meet the Federal 

Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) standard are canceled. These 

decisions are discussed fully in this document. 

I. Introduction 

FIFRA was amended in 1988 to accelerate the reregistration of products with active 

ingredients registered prior to November 1, 1984. The amended Act calls for the 

development and submission of data to support the reregistration of an active ingredient, as 

well as a review of all submitted data by the EPA. Reregistration involves a thorough review 

of the scientific database underlying a pesticide's registration. The purpose of the Agency's 

review is to reassess the potential risks arising from the currently registered uses of the 

pesticide, to determine the need for additional data on health and environmental effects, and 

to determine whether or not the pesticide meets the "no unreasonable adverse effects" criteria 

of FIFRA. 

On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into 

law. This Act amends FIFRA and the FFDCA to require reassessment of all existing 

tolerances for pesticides in food. FQPA also requires EPA to review all tolerances in effect 

on August 2, 1996, by August 3, 2006. In reassessing these tolerances, the Agency must 

consider, among other things, aggregate risks from non-occupational sources of pesticide 

exposure, whether there is increased susceptibility to infants and children, and the cumulative 

effects of pesticides with a common mechanism of toxicity. When a safety finding has been 

made that aggregate risks are not of concern and the Agency concludes that there is a 

reasonable certainty of no harm from aggregate exposure, the tolerances are considered 
2

reassessed. EPA decided that, for those chemicals that have tolerances and are undergoing 

reregistration, tolerance reassessment will be accomplished through the reregistration 

process. 

As mentioned above, FFDCA requires that the Agency consider “available 

information” concerning the cumulative effects of a particular pesticide’s residues and “other 

substances that have a common mechanism of toxicity” when considering whether to 

establish, modify, or revoke a tolerance. Potential cumulative effects of chemicals with a 

common mechanism of toxicity are considered because low-level exposures to multiple 

chemical substances that cause a common toxic effect by a common mechanism of toxicity 

could lead to the same adverse health effect that would occur at a higher level of exposure to 

any one of these individual chemicals. Triadimefon belongs to a group of pesticides called 

triazoles (or conazoles), which also includes the triazole fungicide subject to reregistration, 

propiconazole. Triadimenol, a metabolite of triadimefon, is also a registered fungicide and is 

subject to tolerance reassessment. For the purpose of this reregistration eligibility decision 

(RED) for triadimefon and tolerance reassessment for triadimenol, EPA has concluded that 

triadimefon and triadimenol do not share a common mechanism of toxicity with other 

substances. However, the triazole fungicides share common metabolites, the triazole 

compounds 1,2,4-triazole (free triazole), triazole alanine, and triazole acetic acid, which are 

considered in this document. For information regarding EPA’s efforts to determine which 

chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of 

such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs 

concerning common mechanism determinations and procedures for cumulating effects from 

substances found to have a common mechanism on EPA’s website at 

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

The Agency has identified triazole metabolites of toxicological concern; these include 

1,2,4-triazole and the conjugates triazole alanine and triazole acetic acid. Because these 

metabolites are formed from all triazole pesticides, EPA has conducted a separate toxicology 

assessment for these compounds and concluded that the existing data are sufficient to support 

the reregistration of triadimefon and triadimenol. For more details on the toxicity of the free 

triazoles, see the August 5, 2003, documents, TRIAZOLES – Report of the Ad Hoc HED Peer 

Review Committee, TRIAZOLES – 2nd Report of the Ad Hoc HED Peer Review Committee, 

and the February 7, 2006, document, 1,2,4-Triazole, Triazole Alanine, Triazole Acetic Acid: 

Human Health Aggregate Risk Assessment in Support of Reregistration and Registration 

Actions for Triazole-derivative Fungicide Compounds, which are available under docket 

number EPA-HQ-OPP-2005-0258. Because the risks associated with the free triazoles are 

all below the Agency’s level of concern, they are not discussed further in this document. For 

more information regarding the aggregate assessment of free triazoles, see the July 18, 2006, 

document, Reregistration Eligibility Decision (RED) for Propiconazole, in the Agency’s 

electronic docket on the internet at http://www.regulations.gov under docket number EPAHQ-OPP-2005-0497. 

Triadimefon and triadimenol also share a common metabolite, 1,2,4-triazole, with 

several triazole-derivative pharmaceutical compounds. Thus, EPA must consider the 

incremental impact of exposure to 1,2,4-triazole pesticide residues to individuals using 

triazole-derivative pharmaceutical products. To this end, EPA worked with the U.S. Food 

and Drug Administration (FDA), which has regulatory authority for drug products, to assess 
3

the risks posed by 1,2,4-triazole residues that could result from concurrent exposure to 

triazole-derivative pharmaceutical and pesticide products. This assessment will provide the 

basis of safety findings reflecting the joint perspectives of FDA and EPA, and will inform a 

decision by both Agencies about whether appropriate measures are needed to reduce 

exposure from one or both sources of 1,2,4-triazole residues. 

This document presents a summary of EPA’s revised human health and ecological 

risk assessments, its reregistration eligibility decision for triadimefon and tolerance 

reassessment decision for triadimenol. Occupational and ecological risks from exposure to 

the pesticidal uses of triadimenol are not addressed in this document. The document consists 

of six sections. Section I contains the regulatory framework for reregistration/tolerance 

reassessment. Section II provides a profile of the use and usage of the chemicals. Section III 

gives an overview of the revised human health and environmental effects risk assessments 

based on data, public comments, and other information received in response to the 

preliminary risk assessments. Section IV presents the Agency’s reregistration eligibility, risk 

management and tolerance reassessment decisions. Section V summarizes label changes 

necessary to implement the risk mitigation measures outlined in Section IV. Finally, the 

Appendices list related and supporting documents. The revised risk assessments for 

triadimefon and triadimenol are available in the Agency’s electronic docket on the internet at 

http://www.regulations.gov under docket number EPA-HQ-OPP-2005-0258 and EPA-HQOPP-2006-0038, respectively. 

II. Chemical Overview

A. Regulatory History 

Triadimefon

 Triadimefon is a broad spectrum, systemic fungicide used to control rust and mildew 

on apples, grapes, pears, pineapples, and raspberries. In addition, it is used to control various 

fungal diseases on non-food use sites such as pine seedlings, Christmas trees, residential and 

commercial turf, ornamentals, and landscapes. There are tolerances for triadimefon on 

apples, grapes, pears, pineapples, and raspberries. Triadimefon end-use products are 

marketed in the United States under the trade names Bayleton and Summit. There are 

nineteen active products containing triadimefon (one technical product) registered under 

Section 3 of FIFRA. 

The registrant has agreed to delete all food (except pineapple) and residential turf 

uses. Therefore, this Reregistration Eligibility Decision document evaluates risks from all 

currently supported uses of triadimefon. The Agency will follow the FIFRA cancellation 

with the appropriate tolerance revocations. 

Triadimenol

The primary metabolite of triadimefon is triadimenol. Triadimenol, which degrades 

to include the metabolites KWG 1323 and KWG 1342, is also registered separately as a 

broad spectrum, systemic fungicide under its own active ingredient number (PC code: 
4

127201). Triadimenol is used exclusively in the U.S. as a seed treatment for cotton and 

grains. As a result, it is also being assessed by the Agency for the purposes of a tolerance 

reassessment eligibility decision (TRED). Triadimenol was first registered after 1984 and is 

not subject to reregistration under the 1988 amendments to FIFRA. 

B. Chemical Identification 

1. Technical Triadimefon 

O N

N

N

Cl O C(CH3

)

3

Common Name: Triadimefon 

Chemical Name: 1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)-2-

butanone 

Chemical Family: Azole (Triazoles) 

Empirical Formula: C14H16CLN3O2

CAS Registry Number: 43121-43-3 

Case Number: 2700 

OPP Chemical Code: 109901 

Molecular weight: 293.75 g/mol 

Trade Names: Bayleton and Summit

Basic Manufacturers: Bayer CropScience, LC 

Triadimefon has a melting point of 82.3 degrees Celsius, a solubility of 64 mg/L ppm 

in water 20 degrees Celsius and a vapor pressure of 0.2 – 0.6 mPa at 20 and 25 degrees 

Celsius, respectively (7.6 x 10-7 mm Hg). 
5

2. Triadimenol 

 

Cl

O

HO

CH3

CH3

CH3

N N

N

Common Name: Triadimenol 

Chemical Name: [beta-(4-chlorophenoxy)-alpha-(1,1-dimethylethyl)-1H-1,2,4-

 triazole-1-ethanol] 

Chemical Family: Azole (Triazoles) 

Empirical Formula: C14H18ClN3O2 

CAS Registry Number: 55219-65-3 

Case Number: 2700 

OPP Chemical Code: 127201 

Molecular weight: 295.77 g/mol 

Trade Names: Baytan

Basic Manufacturers: Bayer CropScience, LC 

 

3. Triazole Metabolites 

Triadimefon, triadimenol, and other triazole fungicides are metabolized in animals 

and plants to form compounds containing the triazole moiety, including 1,2,4-triazole (free 

triazole), triazole alanine, and triazole acetic acid, which are also considered in this decision. 

Since triazole alanine and triazole acetic acid are formed by conjunction with an amino acid, 

they are referred to as triazole conjugates throughout this document. Chemical information 

for these triazole metabolites is provided below. 
6

a. 1,2,4-Triazole 

NH

N N

Chemical Name: 1,2,4-Triazole 

Common Name(s): 1,2,4-T; free triazole 

CAS Number: 288-88-0 

PC Code: 600074 

Molecular Weight: 69.07 

b. Triazole Alanine 

N

N

N

NH2

O OH

Chemical Name: Triazole Alanine (TA) 

CAS No.: 86362-20-1 

PC Code: 600011 

Molecular Weight: 156.15 

c. Triazole Acetic Acid 

N

N

N

O

OH

Chemical Name: Triazole Acetic Acid (TAA) 

CAS No.: 28711-29-7 

PC Code: 600082 

Molecular Weight: 127.10 
7

C. Use Profile

 

1. Triadimefon 

The following is information on the currently registered uses of triadimefon, 

including an overview of use sites and application methods. A detailed table of the uses of 

triadimefon eligible for reregistration is contained in Appendix A. 

Type of Pesticide: Broad spectrum, systemic fungicide; demethylation 

inhibitor (DMI). 

Summary of Use: Used for the systemic control of various fungal diseases 

in fruits, turf, pine seedlings, Christmas trees, and 

ornamentals. 

Food uses: Apples, grapes, pears, pineapples, and raspberries. 

 (Registrant is voluntarily deleting use on apples, grapes, 

 pears, and raspberries). 

Non-food uses: Pine seedlings, Christmas trees, residential and 

commercial turf, ornamentals, and landscapes. 

 (Registrant is voluntarily deleting residential turf use). 

Formulation Type: Registered formulations include granular (G)(0.5-1% 

active ingredient), wettable powder (WP)(25-50% 

active ingredient), water soluble packets (50% active 

ingredient), liquid concentrate (LC)(0.88% active 

ingredient), and ready-to-use (RTU)(0.5% active 

ingredient). 

Registrant(s): Bayer CropScience, LP 

Method and Rates of Application:

Application Methods: Applied via ground spray, airblast, aerial spray , 

chemigation, and broadcast (granular only) to apples, 

pears, raspberries, grapes, Christmas trees, ornamentals, 

pine seedlings, and turf (golf course, residential, 

commercial, and recreational). It is also used as a postharvest dip for pineapples and as a seed-piece treatment 

prior to planting. It is also used to treat pine seeds via 

dip, soak, or traditional seed treatment. 

Application Rates: The registrant has agreed to voluntarily delete all food 

(except pineapple) and residential turf use. 
8

 Current maximum application rates are a 5.4 lb. ai/A 

treatment on turf (California only) and a 2.7 lb. ai/A 

treatment on turf outside of California. A maximum 

rate of 0.75 lbs ai/A may be used as a pre-harvest foliar 

treatment on apples and pears (up to 12X per season), 

0.56 lbs ai/A for grapes (up to 6X per season), and 0.88 

lbs ai/A for raspberries (up to 7X per season). A 

maximum rate of 2.0 lbs ai/A may be used for preharvest foliar treatment on both Christmas trees (up to 

8X per season) and pine seedlings (up to 16X per 

season). For pineapple, a maximum rate of 0.28 lbs 

ai/100 gallons solutions may be applied via dip and at a 

maximum rate of 0.28 lbs ai/100 gallons solution via 

dip or spray to the whole fruit following harvest. It is 

also used as a pine seed soak (0.63 lbs ai/100 gal 

solution), and as a pine seed treatment (0.063 lbs ai/100 

gal solution, one time prior to planting. 

Application Timing: Applied pre-plant, foliar and post-harvest. 

 

Use Classification: General 

 2. Triadimenol 

The following is information on the currently registered uses of triadimenol, 

including an overview of use sites and application methods. A detailed table of the uses of 

triadimenol eligible for tolerance reassessment is contained in Appendix A. 

Type of Pesticide: Systemic fungicide for seed treatment. 

Summary of Use: Used as a seed treatment on: barley, corn, cotton, oats, 

rye, sorghum, and wheat. There is also an import 

tolerance on bananas. 

Formulation Type: Registered formulations include emulsifiable 

concentrate (EC) (5% active ingredient), wettable 

powder (WP)(25% active ingredient), soluble 

concentrate (SC) (13.33% active ingredient), and 

flowable concentrate (FlC) (28.3 - 30% active 

ingredient). 

Registrant(s): Bayer CropScience, LP 

Method and Rates of Application:
9

Application Rates: The maximum use rates, adjusted for planting, range 

from 0.006 to 0.0375 lbs. ai/A (0.007-0.042 kg ai/ha) 

for one season. 

Application Timing: Applied pre-plant. 

 

Use Classification: General 

D. Estimated Usage of Pesticide 

1. Triadimefon

Screening level estimates of triadimefon use in the U.S., based on data from the years 

1990 through 2000, have been provided by the Agency’s Biological and Economic Analysis 

Division. Total use averaged 135,000 lbs ai/year with an upper-end estimate of 266,000 lbs 

ai/year. The largest market, in terms of total pounds ai, was seen in the turf and ornamental 

sector. 

2. Triadimenol 

 Based on pesticide usage data for the years 1992 through 2001, total annual domestic 

usage of triadimenol averaged approximately 24,000 pounds of active ingredient (a.i.) for 

over 12,000,000 acres treated. Use on cotton accounted for approximately 75 % of the total 

pounds of a.i. applied annually. Corn and wheat accounted for approximately 20% and 5%, 

respectively. About 80% of U.S. acreage planted to cotton is treated with triadimenol, and 

less than 1 % of corn and wheat acres are treated

III. Summary of Risk Assessments

The following is a summary of EPA's human health and ecological risk findings and 

conclusions for triadimefon and triadimenol, as presented fully in the documents: 

Triadimefon

• Triadimefon. Preliminary Human Health Risk Assessment (Revised). 

February 9, 2006

• Triadimefon/Triadimenol: Summary of Refinements and Revisions to the 

Human Health Risk Assessment. July 10, 2006 

• Triadimefon: Revised Acute, Probabilistic and Chronic Dietary (Food + 

Drinking Water) Exposure and Risk Assessments for the Triadimefon 

Reregistration. July 6, 2006

• Environmental Fate and Effects Chapter (Revised), Risk Assessment for 

Triadimefon. January 19, 2006 

• Triadimefon: HED Response to Comments Received During the Public 

Comment Phase. June 20, 2006 

• Memo: EFED Revisions to the Ecological Risk Assessment. August 3, 2006 
10

• Triadimefon. Summary of Ana--lytical Chemistry and Residue Data for the 

Reregistration Eligibility Decision (RED) Document. November 23, 2005 

• Triadimefon: Occupational and Residential Exposure Assessment for the 

Reregistration Eligibility Decision Document. June 30, 2006 

• Triadimefon and Triadimenol: Aggregate Acute, Chronic, and Short-Term 

Risk Assessments Reflecting July, 2006 Risk Mitigation in Response to the 

Phase 4 Triadimefon RED. August 1, 2006 

• Response to Bayer Public Comments Regarding the Environmental Fate and 

Effects Division Triadimefon Risk Assessment. June 1, 2006 

• Tier 2 Drinking Water Assessment for Triadimefon and its Major Degradate 

Triadimenol. August 31, 2005 

Triadimenol

• Triadimenol: HED Chapter of the Tolerance Reassessment Eligibility 

Decision (TRED) Document (Revised). February 9, 2006 

• Triadimenol. Acute and Chronic Dietary Exposure Assessments for the 

Tolerance Reassessment Eligibility Decision (TRED) Document. November 

18, 2005 

The purpose of this section is to summarize the key features and findings of the risk 

assessments in order to help the reader better understand the risk management decisions 

reached by the Agency. The human health and ecological risk assessment documents and 

supporting information listed in Appendix C were used to reach the safety finding and 

regulatory decisions for triadimefon and triadimenol. Although the risk assessments and 

related addenda are not included in this document, they are available from the OPP Public 

Docket OPP-2005-0258 and OPP-2006-0038, and may also be accessed on the web at 

http://www.regulations.gov. Hard copies of these documents may be found in the OPP 

public docket under these same docket numbers. 

 

A. Human Health Risk Assessment

The human health risk assessment incorporates potential exposure from all sources, 

which for triadimefon includes food, drinking water, residential, and occupational scenarios 

and for triadimenol include food and drinking water scenarios. Aggregate assessments 

combine food, drinking water, and any residential or other non-occupational (if applicable) 

exposures to determine potential exposures to the U.S. population. 

This document summarizes risk estimates for triadimefon (including its metabolite 

triadimenol and degradates KWG 1342 and KWG 1732), and its metabolites 1,2,4-triazole, 

triazole alanine, and triazole acetic acid, which are formed from triazole compounds in 

animals and plants and may be found in food commodities, including animal byproducts. 

1,2,4-Triazole appears to be relatively stable in the environment, and may be found in 

rotational crops and drinking water. A surface water monitoring study showed detections of 

1,2,4-triazole in a small number of samples. Therefore, EPA has considered the risks from 

food, drinking water and non-occupational exposure resulting from triadimefon alone and 
11

from the triazole metabolites from all pesticide sources. For triadimenol, since there are no 

residential uses, EPA considered exposure and risk from food and drinking water In 

addition, EPA has also considered potential co-exposure to free triazoles resulting from 

pharmaceutical uses of triazole compounds. Because the risks associated with the free 

triazoles from all sources are all below the Agency’s level of concern, they are not discussed 

further in this document. Additional details regarding the risks associated with the free 

triazoles, which includes contribution from triadimefon and triadimenol,- may be found in 

the February 7, 2006, document, 1,2,4-Triazole, Triazole Alanine, Triazole Acetic Acid: 

Human Health Aggregate Risk Assessment in Support of Reregistration and Registration 

Actions for Triazole Derivative Fungicide Compounds, which is available in the public 

docket (EPA-HQ-OPP-2005-0258). 

 1. Toxicity of Triadimefon and Triadimenol 

Toxicity assessments are designed to predict whether a pesticide could cause adverse 

health effects in humans (including short-term or acute effects such as skin or eye damage, 

and lifetime or chronic effects such as cancer, developmental and/or reproductive effects), 

and the level or dose at which such effects might occur. The Agency has reviewed all 

toxicity studies submitted and has determined that the toxicity database for triadimefon is 

adequate although there are data gaps (lack of a developmental neurotoxicity study which the 

Agency will remedy through the DCI). In addition, the Agency has reviewed all toxicity 

studies submitted for triadimenol and has determined that the database is adequate. The 

triadimenol data base is less definite than triadimefon; however, because it is a metabolite of 

triadimefon the Agency believes that the use of data on triadimefon can be used for 

triadimenol and be protective regarding any potential risk concerns. Therefore, the Agency 

is not requiring a developmental neurotoxicity (DNT) study for triadimenol. All other 

studies have been submitted to support guideline requirements and a reregistration eligibility 

determination for all currently registered uses. For more details on the toxicity of 

triadimefon, see the February 9, 2006, document, Triadimefon. Preliminary Human Health 

Risk Assessment (Revised), and the July 10, 2006, document, Triadimefon/Triadimenol: 

Summary of Refinements and Revisions to the Human Health Risk Assessment, which is 

available under docket number EPA-HQ-OPP-2005-0258. 

a. Acute Toxicity Profile 

Triadimefon

Triadimefon is classified as category III for acute oral and dermal toxicity and as 

category IV for acute inhalation. It is also classified as category IV for eye irritation 

potential and category IV for skin irritation potential. In addition, triadimefon caused dermal 

sensitization in guinea pigs. The acute toxicity profile for technical grade triadimefon is 

summarized in Table 1 below. The technical acute toxicity values included in this document 

are only to provide background information. Additional acute toxicity data may be required 

to determine appropriate cautionary label language for products containing triadimefon. 
12

Table 1. Acute Toxicity Profile for Triadimefon

Old Guideline 

 No. 

New Guideline 

No. Study Type MRID #(s) Results 

Toxicity 

Category 

81-1 870.1100 Acute Oral - rat 264276 LD50 = 1,470 mg/kg (Males) 

LD50 = 1,090 mg/kg (Females) 

III 

81-2 870.1200 Acute Dermal - 

Rabbit 

264276 LD50 > 2,000 mg/kg III 

81-3 870.1300 Acute Inhalation - rat 41616002 

LC50 > 3.570 mg/L IV 

81-4 870.2400 Acute (Primary) Eye 

Irritation - rabbit 

41782501 Slightly irritating IV 

81-5 870.2500 Acute (Primary) 

Dermal (Skin) 

Irritation - rabbit 

41616004 Not an irritant IV 

81-6 870.2600 Skin (Dermal) 

Sensitization – guinea 

pig 

41554001 Sensitizer Not 

Applicable

Triadimenol

Triadimenol shows low toxicity for acute oral, dermal, and inhalation exposure 

(toxicity Category III or IV) and is not a skin sensitizer. Triadimenol is an eye irritant with 

irritation clearing in 21 days or longer (toxicity Category II), and is a mild dermal irritant 

(toxicity Category IV). The acute toxicity profile for technical triadimenol is summarized in 

Table 2 below. 

Table 2: Acute Toxicity Profile for Triadimenol 

Old 

Guideline 

No. 

New 

Guideline 

No. 

Study Type MRID #(s) Results Toxicity 

Category 

81-1 870.1100 Acute oral –rat 00125411 LD50 = 689 mg/kg (males) 

LD50 = 752 mg/kg (females) 

III 

81-2 870.1200 Acute dermal – 

rabbit 

00145086 LD50 > 2000 mg/kg III 

81-3 870.1300 Acute inhalation – 

rat 

00145087 LC50 > 2.58 mg/L (Limit 

Dose) 

IV 

81-4 870.2400 Acute eye irritation 

– rabbit 

00145088 eye irritant. Irritation cleared 

in 21 days or longer. 

II 

81-5 870.2500 Acute dermal 

irritation – rabbit 

00145088 mild skin dermal irritation IV 

81-6 870.2600 Skin sensitizationguinea pig 

00125413 Not a skin sensitizer Not 

Applicable

 
13

 b. FQPA Safety Factor Considerations 

The FFDCA as amended by the FQPA directs the Agency, in setting pesticide 

tolerances, to use an additional tenfold (10X) margin of safety to protect infants and children, 

taking into account the potential for pre- and post-natal toxicity and the completeness of the 

toxicology and exposure databases. The statute authorizes the Agency to reduce this tenfold 

FQPA safety factor (SF) only if reliable data demonstrate that the resulting level of exposure 

would be safe for infants and children. 

Triadimefon

The current developmental and reproductive toxicity studies do not suggest that the 

young are more sensitive than adult animals. However, since the triadimefon database does 

not include a DNT study, an FQPA safety factor for database uncertainty (10X) has been 

retained for exposure scenarios through which exposure to children or pregnant women is 

expected. A DNT study is required for triadimefon and the Agency will issue a DCI for this 

data. 

Triadimenol

The endpoint of concern for triadimenol, like triadimefon, is neurotoxicity, which was 

observed in rat, mice, and rabbit studies. Evidence of increased susceptibility to offspring 

was not seen in available developmental toxicity studies in two species (rabbits and rats) and 

in a two-generation reproductive toxicity study in rats. Therefore, the Agency is not 

requiring a developmental neurotoxicity (DNT) study for triadimenol at this time, pending 

the results of the acute and subchronic neurotoxicity studies listed in section V of this 

document. However, the Agency is retaining the FQPA Safety Factor (10X) for database 

uncertainty for lack of both acute and subchronic neurotoxicity studies. 

 c. Toxicological Endpoints 

Triadimefon

Table 3 summarizes the studies, toxicological endpoints, dose levels, and 

uncertainty/safety factors selected for the assessment of dietary, oral, dermal, and inhalation 

exposure to triadimefon. Since no appropriate acute endpoint could be determined from the 

triadimenol database, the triadimefon subchronic neurotoxicity study in rats was chosen for 

the acute reference dose (aRfD) for triadimenol, as well. In addition, the subchronic 

neurotoxicity study for triadimefon was also chosen for the chronic reference dose (cRfD) for 

triadimenol. Therefore, the endpoint of concern is neurotoxicity and is the same for both 

triadimefon and triadimenol. 
14

Table 3. Summary of Doses and Toxicological Endpoints for Triadimefon

Exposure 

Scenario 

Dose, Uncertainty 

Factors (UF) 

FQPA Safety Factor 

(SF) and Level of 

Concern 

Study and Toxicological 

Effects 

Acute Dietary 

(general 

population) 

 NOAEL = 3.4 

mg/kg/day (subchronic) 

UF = 100 

Acute RfD = 0.034 

mg/kg/day 

FQPA SF = 10X 

aPAD = acute RfD

 FQPA SF 

aPAD = 0.0034 

mg/kg/day 

Subchronic neurotoxicity study 

in rats (MRID 44153501). 

LOAEL = 54.6 mg/kg/day 

(males) and 68.7 mg/kg/day 

(females) based largely on 

hyperactivity. 

Chronic Dietary 

(all populations) 

NOAEL = 3.4 

mg/kg/day 

UF = 100 

Chronic RfD = 0.034 

mg/kg/day 

FQPA SF = 10X 

cPAD = chronic RfD

 FQPA SF 

cPAD = 0.0034 

mg/kg/day 

Subchronic neurotoxicity study 

in rats (MRID 44153501). 

LOAEL = 54.6 mg/kg/day (M) 

and 68.7 mg/kg/day (F) based 

largely on hyperactivity. 

Incidental Oral 

Short-Term 

(1 - 30 days) 

NOAEL = 3.4 

mg/kg/day 

UF = 100 

FQPA SF = 10X 

Residential MOE = 1000 

Subchronic neurotoxicity study 

in rats (MRID 44153501). 

LOAEL = 54.6 mg/kg/day (M) 

and 68.7 mg/kg/day (F) based 

largely on hyperactivity. 

Dermal 

Short-Term 

(1 - 30 days) and 

IntermediateTerm 

(1 - 6 months) 

Dermal NOAEL = 300 

mg/kg/day 

UF = 100 

Residential MOE = 1000 

FQPA SF = 10X 

Occupational MOE = 100 

21 day dermal toxicity in rats 

(MRID 42341501). 

The LOAEL= 1000 mg/kg/day 

based on increased reactivity 

and activity in the females. 

Inhalation 

Short-Term 

(1 - 30 days) 

NOAEL = 3.4 

mg/kg/day 

(Inhalation absorption 

rate = 100%) 

UF = 100 

Residential MOE = 1000 

FQPA SF = 10X 

Occupational MOE = 100 

Subchronic neurotoxicity study 

in rats (MRID 44153501). 

LOAEL = 54.6 mg/kg/day (M) 

and 68.7 mg/kg/day (F) based 

largely on hyperactivity. 

Inhalation 

IntermediateTerm 

(1 - 6 months) 

NOAEL = 3.4 mg/ 

kg/day 

(Inhalation absorption 

rate = 100%) 

UF = 100 

Residential MOE = 1000 

FQPA SF = 10X 

Occupational MOE = 100 

Subchronic neurotoxicity study 

in rats (MRID 44153501). 

LOAEL = 54.6 mg/kg/day (M) 

and 68.7 mg/kg/day (F) based 

largely on hyperactivity. 

Cancer (oral, 

dermal, 

inhalation) 

Classification: Category C (possible human carcinogen) based on statistically significant 

increase in thyroid adenomas in male Wistar rats and statistically significant increases in 

hepatocellular adenomas in both sexes of the NMRI mouse. 

UF, uncertainty factor; SF, safety factor; NOAEL, no observable adverse effect level; LOAEL, lowest 

observable adverse effect level; RfD, reference dose, exposure which is not expected to exceed EPA’s level 

of concern; PAD, population adjusted dose, which is the RfD adjusted for the FQPA safety factor (SF); 

MOE, margin of exposure; LOC, Level of Concern, MOE at and above which the Agency does not have a 

risk concern. NA, Not Applicable. 
15

Triadimenol

Table 4 summarizes the studies, toxicological endpoints, dose levels, and 

uncertainty/safety factors selected for the assessment of dietary exposure to triadimenol. The 

endpoint of concern is neurotoxicity (same as triadimefon). 

Table 4. Summary of Doses and Toxicological Endpoints for Triadimenol

Exposure 

Scenario 

Dose, Uncertainty 

Factors (UF) 

FQPA Safety Factor 

(SF) and Level of 

Concern 

Study and Toxicological 

Effects 

Acute Dietary 

(general 

population) 

 NOAEL = 3.4 

mg/kg/day (subchronic) 

UF = 100 

Acute RfD = 0.034 

mg/kg/day 

FQPA SF = 10X 

aPAD = acute RfD

 FQPA SF 

aPAD = 0.0034 

mg/kg/day 

Subchronic neurotoxicity study 

in rats (MRID 44153501) for 

triadimefon. 

LOAEL = 54.6 mg/kg/day (M) 

and 68.7 mg/kg/day (F) based 

largely on hyperactivity. 

Chronic Dietary 

(all populations) 

NOAEL = 3.4 

mg/kg/day 

UF = 100 

Chronic RfD = 0.034 

mg/kg/day 

FQPA SF = 10X 

cPAD = chronic RfD

 FQPA SF 

cPAD = 0.0034 

mg/kg/day 

Subchronic neurotoxicity study 

in rats (MRID 44153501) for 

triadimefon. 

LOAEL = 54.6 mg/kg/day (M) 

and 68.7 mg/kg/day (F) based 

largely on hyperactivity. 

Cancer 

(oral, dermal, 

inhalation) 

Classification: Category C “possible human carcinogen” based on increased incidence 

of hepatocellular adenomas in females. 

2. Carcinogenicity 

Triadimefon

The Cancer Assessment Review Committee (CARC) assigned triadimefon a 

classification of "possible human carcinogen", using the criteria in the Draft Guidelines for 

Carcinogen Risk Assessment (July, 1999). This classification is based on a statistically 

significant increase in thyroid adenomas in male Wistar rats and statistically significant 

increases in hepatocellular adenomas in both sexes of the NMRI mouse. However, the 

Agency concluded that a quantified carcinogenic risk assessment for triadimefon is not 

appropriate and risk assessment will be based on the chronic population adjusted dose 

(cPAD) and margin of exposure (MOE) approaches only. 

Triadimenol

 The CARC has assigned triadimenol a classification of “possible human carcinogen”, 

using the criteria in the Draft Guidelines for Carcinogen Risk Assessment (July, 1999). This 

classification is based on increased incidence of hepatocellular adenomas in females. 

However, the Agency concluded that a quantified carcinogenic risk assessment for 

triadimenol is not appropriate and risk assessment will be based on the chronic population 

adjusted dose (cPAD) and margin of exposure (MOE) approaches only. 
16

 3. Endocrine Effects 

EPA is required under the FFDCA, as amended by FQPA, to develop a screening 

program to determine whether certain substances (including all pesticide active and other 

ingredients) “may have an effect in humans that is similar to an effect produced by a 

naturally occurring estrogen, or other such endocrine effects as the Administrator may 

designate.” Following recommendations of its Endocrine Disruptor and Testing Advisory 

Committee (EDSTAC), EPA determined that there was a scientific basis for including, as 

part of the program, the androgen and thyroid hormone systems, in addition to the estrogen 

hormone system. EPA also adopted EDSTAC’s recommendation that the Program include 

evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA 

and, to the extent that effects in wildlife may help determine whether a substance may have 

an effect in humans, FFDCA authority to require the wildlife evaluations. As the science 

develops and resources allow, screening of additional hormone systems may be added to the 

Endocrine Disruptor Screening Program (EDSP). 

Triadimefon and Triadimenol

 The toxicity databases for triadimefon and triadimenol did not show any estrogen, 

androgen, or thyroid mediated toxicity. 

 4. Dietary Exposure and Risk 

 The registrant has agreed to voluntarily cancel all food (apples, pears, grapes, and 

raspberries), except pineapple, and residential turf use for triadimefon1. Thus, these uses 

were not included in this dietary risk assessment. In addition, the registrant is only 

supporting a maximum turf rate of 2 applications of 2.7 lbs. ai/A for golf courses and sod 

farms. Therefore, all drinking water risk estimates were calculated using this rate. 

Dietary risk assessments consider exposure to pesticide residues from both food and 

drinking water. In examining dietary risk, exposures from the use of triadimefon, which 

includes the parent and its metabolites, including triadimenol, as well as exposures from the 

use of triadimenol, which includes the parent and its metabolites, must be added together. 

This is due to the fact that both the acute and chronic PADs are based on the same study (a 

subchronic neurotoxicity study in rats exposed to triadimefon) and therefore must be 

aggregated. To estimate dietary risks from food and drinking water, EPA compares the 

estimated exposure to pesticide residues in food and drinking water to the acute or chronic 

population adjusted dose, or PAD. The PAD is the reference dose (RfD) adjusted for the 

FQPA safety factor. A risk estimate that is less than 100% of the acute PAD (aPAD), the 

dose at which an individual could be exposed over the course of a single day and no adverse 

health effects would be expected, does not exceed EPA’s level of concern. Likewise, a risk 

estimate that is less than 100% of the chronic PAD (cPAD), the dose at which an individual 

could be exposed over the course of a lifetime and no adverse health effects would be 

expected, does not exceed EPA’s level of concern. Additional details about the dietary risk 

 

1

 Bayer no longer wishes to support these uses. The Agency will take regulatory action under FFDCA to revoke 

the associated tolerances. 
17

assessment for triadimefon and triadimenol are described in the July 6, 2006, document, 

Triadimefon. Revised Acute and Chronic Dietary (Food + Drinking Water) Exposure and 

Risk Assessments for the Triadimefon Reregistration and in the February 9, 2006, document,

Triadimenol: HED Chapter of the Tolerance Reassessment Eligibility Decision (TRED) 

Document (Revised). 

 Acute PAD. As discussed in Section III of this document, the Agency used the 

subchronic neurotoxicity study (SCN) for triadimefon to establish the acute RfD that is used 

for both chemicals. The endpoint of concern is neurotoxicity seen after both an acute gavage 

and repeated dietary exposure. The NOAEL was 3.4 mg/kg/day. The aPAD is 0.0034 

mg/kg/day. Dietary risk results >100% of the aPAD are above the Agency’s level of 

concern. Refer to Table 3 above. 

 Chronic PAD. Combined dietary risk for triadimefon and triadimenol was assessed 

by comparing chronic dietary exposure estimates (in mg/kg/day) to the triadimefon cPAD. 

Dietary risk is expressed as a percent of the cPAD, which is the chronic RfD (3.4 mg/kg/dayNOAEL) modified by an uncertainty factor of 1000 (10X for inter-species extrapolation, 10X 

for intra-species variability, and 10X FQPA safety factor for database uncertainty- lack of a 

developmental neurotoxicity study). Therefore, the cPAD for triadimefon and triadimenol is 

0.0034 mg/kg/day. Dietary risk results >100% of the cPAD are above the Agency’s level of 

concern. The cPAD was derived from a subchronic neurotoxicity study in rats, which 

accounted for the most sensitive species and endpoints (rat versus chronic dog study), with a 

LOAEL of 54.6 (male) and 68.7 (female) mg/kg/day as noted in Table 3 above. 

 a. Dietary (Food) Risk Assessment 

The Agency conducted acute and chronic dietary exposure assessments using the 

Dietary Exposure Evaluation Model software with the Food Commodity Intake Database 

(DEEM-FCID, Version 2.03), which incorporates consumption data from USDA’s 

Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998. 

 1) Acute Dietary Food Risk 

A probabilistic (Monte-Carlo) acute dietary exposure assessment was conducted 

based on field trial data and 100% crop treated (%CT) at the 95th percentile. The risk 

assessment combined exposure for both triadimefon and triadimenol. Acute dietary (food 

only) risk estimates were based on field trial data for pineapples (triadimefon and 

triadimenol) and bananas (triadimenol), plus seed treatment uses on cotton and grain (barley, 

corn, oats, rye, sorghum, and wheat) from triadimenol based on a tolerance level approach 

and assuming 100% crop treated. The ratio of total toxic residues (TTR) to triadimefon, 

from available metabolism studies, was used to estimate the total residues of concern. 

For food alone, acute dietary risk estimates are below the Agency’s level of concern 

(<100% aPAD) at the 95th percentile exposure for children 1-2 years old at 32% of the aPAD, 

the most highly exposed population subgroup. The 95th percentile of exposure is the 

appropriate percentile to use given the level of refinement (i.e., unrefined) of the residue 

values used and that 100% of the crops are assumed to be treated. Refer to Table 5 below. 
18

Table 5. Results of Acute Dietary Exposure Analysis for Food Alone Using DEEMFCID

95th Percentile 

Population Subgroup aPAD (mg/kg/day) Exposure (mg/kg/day) % aPAD 

General U.S. Population 0.0034 0.000520 15 

All Infants (< 1 year old) 0.0034 0.000828 24 

Children 1-2 years old 0.0034 0.001083 32 

Children 3-5 years old 0.0034 0.000923 27 

Children 6-12 years old 0.0034 0.000668 20 

 

 2) Chronic Dietary Food Risk

 

Chronic dietary exposure assessments were also conducted using the Dietary 

Exposure Evaluation Model software with the Food Commodity Intake Database (DEEMFCID, Version 2.03), which incorporates consumption data from USDA’s Continuing 

Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998. 

The risk assessment combined exposure for both triadimefon and triadimenol. 

Chronic dietary (food only) risk estimates were based on field trial data for pineapples 

(triadimefon and triadimenol) and bananas (triadimenol), plus seed treatment uses on cotton 

and grain (barley, corn, oats, rye, sorghum, and wheat) from triadimenol using a tolerance 

level approach and assuming 100% crop treated. 

For all supported commodities, the chronic dietary exposure to triadimefon from food 

(only) is below the Agency’s level of concern (<100% cPAD) for the U.S. population (6% 

cPAD) and all population subgroups, including children 1-2 years old (15% of the cPAD), 

the most highly exposed subgroup. Refer to Table 6 below. 

Table 6. Results of Chronic Dietary Exposure Analysis for Food Alone Using DEEMFCID

Food Alone 

Population Subgroup cPAD (mg/kg/day) Exposure (mg/kg/day) % cPAD 

General U.S. Population 0.0034 0.000194 6 

All Infants (< 1 year old) 0.0034 0.000227 7 

Children 1-2 years old 0.0034 0.000493 15 

Children 3-5 years old 0.0034 0.000471 14 

Children 6-12 years old 0.0034 0.000323 10 
19

 b. Dietary Exposure from Drinking Water 

Surface Water Exposure

Triadimefon and triadimenol can be transported to surface water during or after 

application via run-off and/or erosion as well as soil leaching from ground applications. The 

triadimefon surface water assessment is based on Florida turf use. This scenario was chosen 

because it is expected to present the greatest risk to drinking water supplies. Because water 

monitoring data for triadimefon are limited, the Agency used screening-level models to 

estimate drinking water concentrations of triadimefon from surface water. 

Since current labels do not limit the number of applications, EECs were calculated for 

a range of numbers of applications for residential and golf/sod turf. However, Bayer, the 

technical registrant, is only supporting a maximum turf rate of 2 applications of 2.7 lbs. ai/A 

for golf courses and sod farms. As a result, only those results are presented here. Since there 

is no limitation for application to tees, greens, and/or fairways, “entire course” values (also 

applies to sod farm use) were used in determining potential surface drinking water 

concentration(s). 

A summary of the surface water concentration scenarios is presented below in Table 

7. For additional information, refer to the Tier 2 Drinking Water Assessment for Triadimefon 

and its Major Degradate Triadimenol, dated August 31, 2005. 

Table 7. Estimated Concentrations of Triadimefon and its Degradate Triadimenol in 

Surface Drinking Water Using PRZM/EXAMS Scenarios (Turf)

Use Scenario Portion of Golf Chronic Concentration (ppb)

Course- (Treated) 

Acute 

Concentration (ppb) 1 in 10 year 

annual mean 

(non-cancer) 

(ppb) 

30-year 

overall mean 

(cancer) 

(ppb) 

2 applications 

14 day interval 

2.75 lbs ai/A 

(1 oz/1000 ft2

)

Entire Course 93.5 19.6 9.1 

Groundwater Exposure

As an initial screen, the concentrations expected in ground water for the use of 

triadimefon were estimated using the SCI-GROW model (Tier 1 Ground Water Computer 

Model). In addition, groundwater monitoring studies were supplied by the registrant, Bayer 

CropScience. Although SciGrow should typically over-estimate expected ground water 

concentrations, in this case the model actually underestimated the SciGrow predicted value in 

at least one instance. A ground water monitoring study in New Jersey, which reflected 

suggested turf uses, showed a peak groundwater concentration of 25 ppb, while the SciGrow 

estimate for similar usage yielded an estimate of only 3.36 ppb. Therefore, the potential for 

ground water triadimefon contamination may be greater than supposed. Although the ground 

water monitoring values were lower than surface water modeled values, there may be an 
20

unforeseen risk to private shallow ground water wells used for drinking water in areas where 

triadimefon is applied. This may be further exacerbated by the fact that, unlike surface 

water, which is generally treated prior to use, private well water may be used in the home 

with no pre-treatment. However, although the Agency recognizes the potential for 

groundwater contamination, surface water estimates in this case are considered protective for 

ground and/or drinking water contributions. For more information on drinking water risks 

and representative calculations, see the Water Exposure/Risk Pathway section of the revised 

human health risk assessment, dated February 9, 2006. 

 c. Dietary Risk from Drinking Water 

Drinking water exposure to pesticides can occur through ground and surface water 

contamination. In assessing drinking water risks, EPA considers acute (one-day) and chronic 

(long-term) exposure, and uses modeling and monitoring data, if available, to estimate those 

exposures. Given the limited use patterns of triadimenol (seed treatment) and the amount of 

pesticide available on a per acre basis, drinking water exposures resulting from the use of 

triadimefon in both surface and ground water are much greater. Consequently, the Agency is 

using the exposure values from the use of triadimefon in its assessments which is protective 

of any drinking water exposure from the use of triadimenol. Estimated environmental 

drinking water concentrations (EDWCs) for triadimefon were calculated using the PRZMEXAMS model. The assessment also accounted for triadimenol as the primary degradate in 

water. The PRZM-EXAMS assessment considers 100% of the golf course was treated and 

that the watershed was 100% golf course. Based on these conservative assumptions, the 

Agency is regulating at the 95 percentile. The distribution of estimated residues of 

triadimefon and triadimenol were incorporated directly into the acute dietary assessment. 

Triadimefon transforms into triadimenol in the natural environment, particularly in 

shallow subsurface soil and is moderately mobile and persistent. Triadimefon on or near 

the soil surface or on vegetation may be subject to runoff and/or erosion into surface water 

bodies used as drinking water supplies. Triadimefon and triadimenol may also leach into 

groundwater when triadimefon is applied in areas with well-drained soil, high rainfall 

(and/or irrigation) rates, and shallow water tables. Once it reaches groundwater, 

triadimenol is likely to degrade more slowly than the parent compound. Both parent and 

degradate are stable to hydrolysis and have fairly long half-lives in soil and water. The 

Agency modeled surface drinking water values which are higher than groundwater 

estimates, and are therefore protective for dietary risk analyses. 

 

 1) Acute Dietary Water Risk 

The Agency believes it is appropriate to use the 95th percentile as the level of 

concern (LOC) for drinking water because the drinking water assessment is conservative. 

The following factors provide the rationale for this approach: 1) the Agency assumes that 

100 percent of the watershed is in golf courses (100 percent cropped area (PCA)), and 

therefore 100% of the watershed is turf treated with triadimefon; 2) residue estimates were 

modeled using PRZM-EXAMS, which usually results in higher water concentration values 

than would monitoring data; 3) the dose spacing between the NOAEL and LOAEL in the 
21

guideline acute and subchronic neurotoxicity studies is fairly large; and 4) the entire golf 

course is assumed to be treated. 

 Acute dietary (water only) risk estimates were based on a FL golf course scenario 

for triadimefon. The acute dietary exposure to triadimefon from water (only) is below the 

Agency’s level of concern (<100% cPAD) for the U.S. population (24% aPAD) and all 

population subgroups, including all infants (< 1 year old) (85% of the aPAD), the most 

highly exposed subgroup (See Table 8). 

Table 8. Results of Acute Dietary Exposure Analysis for Water (only) Using DEEMFCID

95th Percentile 

Population Subgroup aPAD (mg/kg/day) Exposure (mg/kg/day) % aPAD 

General U.S. Population 0.0034 0.000812 24 

All Infants (< 1 year old) 0.0034 0.002904 85 

Children 1-2 years old 0.0034 0.001235 36 

Children 3-5 years old 0.0034 0.001148 34 

Children 6-12 years old 0.0034 0.000789 23 

2) Chronic Dietary Water Risk 

 Chronic dietary (water only) risk estimates were based on this scenario 

incorporating both triadimefon and its degradate triadimenol to determine risk values. The 

chronic dietary exposure to triadimefon from water (only) is below the Agency’s level of 

concern (<100% cPAD) for the U.S. population (12% cPAD) and all population subgroups, 

including non-nursing infants (49% of the cPAD), the most highly exposed subgroup (See 

Table 9). 

Table 9. Results of Chronic Dietary Exposure Analysis for Water (only) Using DEEMFCID

95th Percentile 

Population Subgroup cPAD (mg/kg/day) Exposure (mg/kg/day) % cPAD 

General U.S. Population 0.0034 0.000414 12 

Infants (non-nursing) 0.0034 0.001681 49 

Children 1-2 years old 0.0034 0.000615 18 

Children 3-5 years old 0.0034 0.000575 17 

Children 6-12 years old 0.0034 0.000397 12 
22

 5. Residential (Non-dietary) Exposure and Risk 

Triadimefon

 The registrant has agreed to voluntarily delete residential turf use based on exposure 

to toddlers. 

Triadimenol

 There are no residential uses of triadimenol products. 

 Currently, triadimefon products are marketed for homeowner use on residential 

lawns, landscape ornamentals, and trees. Triadimefon-containing products are also marketed 

for use by professional applicators (Pest Control Operators, or PCOs) on residential turf, on 

golf courses, other turf such as recreational/commercial areas, and on ornamental plantings. 

Based on these uses, triadimefon is assessed for the residential handler, and for postapplication dermal contact for adults, youths, and for toddler’s post-application incidental 

oral exposure that may occur from turf contact. Residential exposure may occur during and 

after application at homes, or after applications at golf courses, parks, schools, or other turf 

sites. Each route of exposure (oral, dermal, inhalation) is assessed, where appropriate, and 

risk is expressed as a Margin of Exposure (MOE > 1000 does not exceed the Agency’s Level 

of Concern). For more information on residential exposure and risk, refer to the document, 

Triadimefon: Occupational and Residential Exposure Assessment for the Reregistration 

Eligibility Decision Document, dated June 30, 2006. 

a. Residential Handler Risk 

The anticipated use patterns and current labeling indicate several residential handler 

exposure scenarios based on the types of equipment and techniques that can be used to make 

triadimefon applications. The quantitative short-term exposure/risk assessment developed 

for residential handlers is based on these scenarios. Intermediate-or long-term exposures are 

not likely because of the intermittent nature of applications by homeowners. 

(Mixer/Loader/Applicators): 

(1) Liquid Formulations: Low Pressure Handwand (ORETF data for ornamentals) 

 (2) Wettable Powder Formulations: Low Pressure Handwand (PHED data) 

(3) Liquid Concentrates with Hose-End Sprayer (Residential ORETF data -- 

ornamental shrubs) 

 (4) Wettable Powders with Hose-End Sprayer (Residential ORETF data -- liquid 

 concentrate application to ornamentals) 

 (5) Liquid Concentrates with a Tree Injector (no data) 

 (6) Loading/Applying Granulars via Push Type Spreader (ORETF data) 

 (7) Loading/Applying Granulars via Belly Grinder (PHED data) 
23

Inhalation risks for residential handlers are not a concern for all residential uses of 

triadimefon. Combined dermal and inhalation risks for residential handlers are not a concern 

(MOEs >1000) for the following scenarios: 

(1) Mixing/loading/applying liquid and wettable powder formulations to outdoor and 

greenhouse flowers, trees, and shrubs with a low pressure handwand; 

(2) Loading/applying granulars via push type spreader and belly grinder. 

 

However, combined risks remain a concern (MOEs < 1000) for 

mixing/loading/applying liquid concentrates/ wettable powders with a hose-end sprayer to 

greenhouse ornamentals. Short-term risks for residential handlers are presented below in 

Table 10, which only represents those scenarios that exceed the Agency’s level of concern 

(MOE < 1000). 

Table 10. Triadimefon Residential Handler Risks 

Baseline Unit Exposure MOEs 

Exposure 

Scenario 

Crop or 

Target 

App 

Ratea 

(lb ai 

/gallon) 

Area 

Treated 

Dailyb 

(gallons)

Dermalc

(mg/lb 

ai) 

Inhalationd 

(mg/lb ai) 

Baseline 

Dermal 

Baseline 

Inhalation 

Baseline 

Dermal + 

Baseline 

Inhalation 

MOE 

Mixer/Loader/Applicator

Mixing/ 

Loading/ 

Applying 

Liquid 

Concentra

tes with 

Hose-End 

Sprayer 

Greenhouse 

ornamentals 

(shrubs, 

trees) 0.00938 100 39 1.6 490 160000 490 

Mixing/ 

Loading/ 

Applying 

Liquid 

Concentra

tes with 

Hose-End 

Sprayer 

Greenhouse 

ornamentals 

(flowering) 0.00938 100 34 0.82 560 310000 560 

Mixing/ 

Loading/ 

Applying 

Wettable 

Powders 

with 

Hose-End 

Sprayer 

Greenhouse 

ornamentals 

(flowering) 0.00625 100 34 0.82 850 460000 850 
24

Baseline Unit Exposure MOEs 

Exposure 

Scenario 

Crop or 

Target 

App 

Ratea 

(lb ai 

/gallon) 

Area 

Treated 

Dailyb 

(gallons)

Dermalc

(mg/lb 

ai) 

Inhalationd 

(mg/lb ai) 

Baseline 

Dermal 

Baseline 

Inhalation 

Baseline 

Dermal + 

Baseline 

Inhalation 

MOE 

a Application rates are the maximum application rates determined from EPA registered labels for 

triadimefon. 

b Amount handled per day values are EPA estimates of acres, square feet, or cubic feet treated or gallons 

applied based on Exposure SAC, SOP #9 Standard Values for Daily Acres Treated in Agriculture, and 

industry sources, and EPA estimates. 

c Baseline Dermal: Long-sleeve shirt, long pants, no gloves. 

d Baseline Inhalation: no respirator. 

 

 b. Residential Post-application Exposure and Risks

The Agency uses the term “post-application” to describe exposures to individuals that 

occur as a result of being in an environment that has been previously treated with a pesticide. 

Triadimefon can be used in many areas that can be frequented by the general population 

including residential areas (e.g., home lawns and gardens). As a result, individuals can be 

exposed by entering these areas if they have been previously treated. 

Exposures were calculated by considering the potential sources of exposure (e.g., 

dislodgeable foliar residues (DFRs) on ornamental plants) for both triadimefon and 

triadimenol, then calculating dermal and non-dietary ingestion exposures and risks. 

Individuals of varying ages can potentially be exposed to triadimefon when they are in areas 

that have been previously treated. Post-application exposure scenarios were developed for 

each residential setting where triadimefon can be used. The scenarios that were assessed are 

dermal exposure to adults, dermal exposure to youths, and dermal and incidental oral 

exposure to toddlers from those uses which remain where there is a potential for postapplication exposure. 

 Risk Summary: 

Risks were calculated using the Margin of Exposure (MOE) approach, which is a 

ratio of the body burden to the toxicological endpoint of concern. Risks to adults and youths 

are below the Agency’s level of concern (See Table 11 & 12 below). 
25

Table 11. Adult Residential Risk Estimates for Post-application Exposure to 

Triadimefon (including Triadimenol)

Exposure Scenario Route of 

Exposure Formulation Application Rate (lb ai/acre) 

MOE at Day 

0 

Outdoors – with default transferable residues

Home Garden (Ornamentals) Dermal Spray 0.25 4,800 

Golfer Dermal Spray/Granular 1.3 (Bayer max 

residential) 12,000 

Table 12. Youth Residential Risk Estimates for Post-application Exposure to 

Triadimefon (including Triadimenol)

Exposure Scenario Route of 

Exposure Formulation Application Rate (lb ai/acre) 

MOE at Day 

0 

Outdoors – with default transferable residues

Home Garden (Ornamentals) Dermal Spray/Granular 0.25 13,000 

Golfer Dermal Spray/Granular 1.3 (Bayer max 

residential) 7,800 

The registrant has agreed to voluntarily cancel all residential turf use and include a 

pre-transplant interval of 17 days to sod farms in order to address any potential concerns for 

post-application exposure to toddlers. 

Additional details regarding the residential exposure and risk assessments for 

triadimefon may be found in the following documents: Triadimefon. Occupational and 

Residential Exposure Assessment for the Reregistration Eligibility Decision Document, dated 

June 30, 2006. 

 6. Aggregate Exposure/Risk from Triadimefon and Triadimenol 

The FQPA amendments to the FFDCA, section 408(b)(2)(A)(ii)) require the Agency 

to determine “that there is a reasonable certainty that no harm will result from aggregate 

exposure to the pesticide chemical residue, including all anticipated dietary exposures and 

other exposures for which there is reliable information.” Aggregate exposure will typically 

include exposures from food, drinking water, residential uses of a pesticide, and other non-
26

occupational sources of exposure. When aggregating exposure and risk from various 

sources, the Agency considers the route and duration of exposure. 

Acute (Food and Water) 

 The Agency believes it is appropriate to use the 95th percentile as the level of 

concern (LOC) for the entire golf course because it is a highly conservative approach. The 

following factors provide the rationale for this approach: 1) the Agency assumes that 100 

percent of the watershed is in golf courses (100 percent cropped area (PCA)), and therefore 

100% of the watershed is turf treated with triadimefon; 2) residue estimates were modeled 

using PRZM-EXAMS, which usually results in higher water concentration values than 

would monitoring data; 3) the dose spacing between the NOAEL and LOAEL in the 

guideline acute and subchronic neurotoxicity studies for triadimefon are fairly large; and 4) 

the Agency assumes that the entire golf course is treated. 

 Combined acute dietary (food and water) risk estimates from pineapples (triadimefon) 

and drinking water (triadimefon from golf course application to entire golf course) plus seed 

treatment uses and banana import tolerance (triadimenol) are below the Agency’s level of 

concern (<100% aPAD) at the 95th percentile of exposure (assuming 2 applications per year 

for turf at 2.7 lbs ai/A). The dietary exposure for acute food and drinking water is 33% of the 

aPAD for the U.S. population and 94% of the aPAD for all infants less than one year old, the 

most highly exposed population subgroup. A summary of acute dietary risk estimates (food 

+ drinking water) is presented below in Table 13. 

Table 13. Triadimefon and Triadimenol Results of Acute Dietary Exposure Analysis 

for Food + Drinking Water From the Golf Course (entire) Use Scenario Using DEEMFCID 

95th Percentile 

Population Subgroup aPAD (mg/kg/day) Exposure (mg/kg/day) % aPAD 

General U.S. Population 0.0034 0.001106 33 

All Infants (< 1 year old) 0.0034 0.003190 94 

Children 1-2 years old 0.0034 0.001959 58 

Children 3-5 years old 0.0034 0.001765 52 

Children 6-12 years old 0.0034 0.001210 36 

Chronic (Food and Water)

 Combined chronic dietary (food and water) risk estimates were derived from 

pineapples and drinking water (entire golf course-triadimefon) plus seed treatment uses and 

bananas import tolerance from triadimenol. Drinking water exposures are based on using the 

1 in 10 year annual mean concentration assuming 2 applications per year for turf at 2.7 lbs 

ai/A. The dietary exposure for chronic food and drinking water is below the Agency’s level 

of concern and is 18% of the cPAD for the U.S. population and 57% of the cPAD for non-
27

nursing infants, the most highly exposed population subgroup. A summary of chronic 

dietary risk estimates (food + drinking water) is presented below in Table 14. 

Table 14. Triadimefon Results of Chronic Dietary Exposure Analysis for Food + 

Drinking Water From the Golf Course (entire) Using DEEM-FCID

95th Percentile 

Population Subgroup cPAD (mg/kg/day) Exposure (mg/kg/day) % cPAD 

General U.S. Population 0.0034 0.000607 18 

Infants (non-nursing) 0.0034 0.001952 57 

Children 1-2 years old 0.0034 0.001108 33 

Children 3-5 years old 0.0034 0.001047 31 

Children 6-12 years old 0.0034 0.000720 21 

Short-term (Food + Water + Residential)

The exposure attributable to residential uses of triadimefon were not initially 

aggregated with dietary sources of exposure (food plus drinking water) because at that time 

the dietary and residential exposure pathways separately exceeded the Agency’s level of 

concern. The registrant agreed to voluntarily delete residential turf uses and all food uses 

(except pineapple) so that the aggregate risks are within acceptable levels. Taking into 

consideration the agreement to request deletion of these uses and mitigation requiring a 17-

day post-application, pre-transplant interval for sod farms, risks will be below the Agency’s 

level of concern. 

 Aggregate exposures to toddlers, youths, and adults could occur from triadimefon 

uses on golf courses and in residential settings from turf transplanted from sod farms. The 

Agency assessed short-term aggregate risks to adults and toddlers by calculating an aggregate 

risk MOE assuming background (chronic) exposure to triadimefon and triadimenol residues 

from dietary (food and water) sources. The chronic exposure from drinking water considers 

treatment of an entire golf course. Short-term aggregate risk, calculated as an MOE, is 1100 

for toddlers (from the turf use), and 1300 for adults and for youths (from the golf course use). 

None of these estimates exceed the Agency’s level of concern. 

 Aggregate exposures could also occur for adults making applications to residential 

ornamentals. Using this scenario and assuming an application rate of 0.005 to 0.0025 lb. 

ai/gallon with the highest exposure scenario that is still below the Agency’s level of concern 

(mixing/loading/applying wettable powders with a low pressure handwand to greenhouse 

ornamentals), aggregate (food + water + residential) risk is below the Agency’s level of 

concern (MOE = 1300). 

 The combined risk assessment for exposures to toddlers following the application of 

sod farm turf transplanted to a residential lawn are not a concern (MOEs > 1000) at day 17 

following application to sod farms at the 2.7 lbs ai/A rate. Therefore, the labels for these 
28

products must be restricted to not allow transplantation earlier than the 17th day after 

treatment. 

Intermediate-term and Chronic (Food + Water + Residential) 

 Intermediate-term and chronic residential exposures to triadimefon are not expected 

because of the intermittent nature of applications in residential settings. Therefore, 

intermediate-term chronic aggregate risk assessments were not conducted. 

 7. Pesticide and Pharmaceutical Co-Exposure Assessment for 

The Triazole Metabolites 

FFDCA Section 408 requires EPA to consider potential sources of exposure to a 

pesticide and related substances in addition to the dietary sources expected to result from a 

pesticide use subject to a tolerance (legal limit for pesticide residue levels) in food or feed 

commodities. In determining whether to maintain a pesticide tolerance, EPA must 

“determine that there is a reasonable certainty of no harm...” in accordance with FFDCA, 

Section 408(b)(2)(A)(ii). The FDA regulates human drugs for safety and effectiveness under 

FFDCA section 505 and may approve use of a drug in humans notwithstanding the 

possibility that some individual patients may experience adverse side effects. EPA does not 

believe that, for purposes of the section 408 dietary risk assessment, it is compelled to treat a 

pharmaceutical patient the same as a non-patient, or to assume that combined exposures to 

pesticide and pharmaceutical residues that lead to a physiological effect in the patient 

constitutes “harm” under the meaning of section 408 of the FFDCA. 

Rather, EPA believes that an appropriate way to consider the metabolite 1,2,4-triazole 

resulting from pharmaceutical use of triazole-derivative drugs would be to consider the 

additional contribution that non-occupational pesticide exposure would have to a 

pharmaceutical patient exposed to the same compound. Where the additional pesticide 

exposure has no more than a minimal impact on the pharmaceutical patient, EPA can make a 

“reasonable certainty of no harm” finding for the pesticide tolerances of that compound 

under FFDCA Section 408. If the potential impact on the pharmaceutical user as a result of 

co-exposure from pesticide use is more than minimal, then EPA would not be able to 

conclude that dietary residues were safe, and would need to discuss with FDA appropriate 

measures to reduce exposure from one or both sources. 

As previously mentioned, triadimefon may share a common metabolite, 1,2,4-

triazole, with triazole-derivative pharmaceutical compounds. Thus, EPA consulted with 

FDA on triazole drugs that could metabolize to 1,2,4-triazole and the Agencies concluded 

that only one compound, anastrozole, a chemotherapy drug used to treat breast cancer, had 

this metabolic pathway in humans. Because anastrozole is used at very small doses in a 

limited population of patients, EPA conducted a conservative screening-level assessment to 

determine whether the combined metabolites from triazole pesticide uses and anastrozole 

would adversely impact pharmaceutical users. EPA concluded that, using upper-bound 

estimates for metabolites of anastrozole, the combined metabolite exposure is below the 

Agency’s level of concern. Because EPA is able to reach this conclusion with a screeninglevel assessment, the Agency has not conducted a more refined co-exposure assessment for 
29

pharmaceutical uses as described above. Therefore, EPA concludes that the potential dietary 

pesticide exposure to triazole pesticide residues in food and water will result in no harm to a 

patient being treated with anastrozole. Please see the May 19, 2006, memo from FDA and 

the July 18, 2006, EPA document summarizing EPA and FDA discussions on potential free 

triazole metabolites of triazole derivative drugs, (both available in the public docket for 

triadimefon, EPA-HQ-OPP-2005-0258) for additional information. 

 8. Cumulative Risk Assessment 

Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to 

establish, modify, or revoke a tolerance, the Agency consider “available information” 

concerning the cumulative effects of a particular pesticide’s residues and “other substances 

that have a common mechanism of toxicity.” Other substances are considered to account for 

the possibility that low-level exposures to multiple chemical substances that cause a common 

effect by a common mechanism could lead to the same adverse health effect as would a 

higher level of exposure to each individual substance. For the purposes of this reregistration 

eligibility decision, EPA has concluded that triadimefon and triadimenol do not share a 

common mechanism of toxicity with other substances. The Agency reached this conclusion 

after a thorough internal review and external review of the data supporting a common 

mechanism of toxicity for a number of chemical classes. Triadimefon, triadimenol, and the 

other triazole fungicides share the common metabolites 1,2,4-triazole, triazole alanine, and 

triazole acetic acid, which are considered in this RED. 

 9. Occupational Risk 

The registrant has agreed to voluntarily delete all uses on apples, pears, grapes, 

raspberries, and residential turf. Occupational post-application exposure and risk assessment 

for agricultural uses of triadimefon indicates that risks are not a concern at day 0 (i.e., 12 

hours after application) for all use sites and all post-application activities. 

Workers can be exposed to a pesticide through various routes/pathways. There is 

potential for exposure to triadimefon in occupational scenarios from handling triadimefon 

products during the application process (i.e., mixer/loaders, applicators, flaggers, and 

mixer/loader/applicators), and a potential for post-application worker exposure from entering 

into areas previously treated with triadimefon. In addition, there is potential exposure to 

workers who treat seed with triadimefon in commercial and nursery settings and to persons 

who plant treated seed. Occupational risk for all of these potentially exposed populations is 

measured by a MOE, which determines how close the occupational exposure comes to a dose 

level or NOAEL. 

Occupational risk is assessed for exposure at the time of application (termed 

“handler” exposure) and following application (termed post-application exposure). 

Application parameters are generally defined by the physical nature of the formulation (e.g., 

formula and packaging), by the equipment required to deliver the chemical to the use site, 

and by the application rate required to achieve an efficacious dose. Post-application risk is 

assessed for activities such as scouting, irrigating, pruning, and harvesting, and is based 

primarily on dermal exposure estimates. Note that occupational risk estimates are intended 
30

to represent pesticide workers, and on this basis assumptions are made concerning acres 

treated per day and the seasonal duration of exposure. 

Triadimenol is only being reviewed for tolerance reassessment purposes. Currently 

registered uses do not involve occupational exposures. Therefore, no worker risk assessment 

was completed. 

For more information on the assumptions and calculations of potential risk of 

triadimefon to workers, refer to the documents entitled: Triadimefon. Occupational and 

Residential Exposure Assessment for the Reregistration Eligibility Decision Document, dated 

June 30, 2006; and the memorandum: Triadimefon/Triadimenol: Summary of Refinements 

and Revisions to the Human Health Risk Assessment, dated July 10, 2006. 

 a. Occupational Toxicity

Table 15 below provides a listing of the toxicological endpoints used in the 

triadimefon occupational risk assessment. 

Table 15. Toxicological Endpoints for the Triadimefon Occupational Risk Assessment 

Exposure 

Scenario 

Dose Used in Risk 

Assessment, UF 

Level of Concern for 

Risk Assessment Study and Toxicological Effects 

Dermal 

Short-Term 

(1 - 30 days) 

Dermal NOAEL = 

300 mg/kg/day 

 UF = 100 

Occupational 

MOE = 100 

21 day dermal toxicity in rabbits. 

The LOAEL= 1000 mg/kg/day based 

on increased reactivity and activity in 

the females. 

Dermal 

IntermediateTerm 

(1 - 6 months) 

Dermal NOAEL = 

300 mg/kg/day 

 UF = 100 

Occupational 

MOE = 100 

21 day dermal toxicity in rabbits. 

The LOAEL= 1000 mg/kg/day based 

on increased reactivity and activity in 

the females. 

Inhalation 

Short-Term 

(1 - 30 days) 

NOAEL = 3.4 

mg/kg/day 

(Inhalation 

absorption rate = 

100%) 

 UF = 100 

Occupational 

MOE = 100 

Subchronic neurotoxicity study in rats. 

LOAEL = 54.6/68.7 mg/kg/day based 

largely on hyperactivity. 

Inhalation 

IntermediateTerm 

(1 - 6 months) 

NOAEL = 3.4 mg/ 

kg/day 

(Inhalation 

absorption rate = 

100%) 

 UF = 100 

Occupational 

MOE = 100 

Subchronic neurotoxicity study in rats. 

LOAEL = 54.6/68.7 mg/kg/day based 

largely on hyperactivity. 

Cancer (oral, 

dermal, 

inhalation) 

Classification: Category C (possible human carcinogen) based on statistically significant 

increase in thyroid adenomas in male Wistar rats and statistically significant increases in 

hepatocellular adenomas in both sexes of the NMRI mouse. 
31

 b. Occupational Handler Exposure 

Occupational handler risk estimates have been assessed for both short- and 

intermediate-term exposure durations. Due to the use patterns for triadimefon, long-term 

exposures are not expected. Since the endpoints and points of departure (PODs) are identical 

to assess short and intermediate exposure, these risk estimates represent both durations of 

exposure. 

Occupational handler assessments are conducted using increasing levels of protection. 

The Agency typically evaluates all exposures with minimal protection and then considers 

additional protective measures using a tiered approach in an attempt to obtain an adequate 

MOE. The lowest tier is represented by the baseline clothing scenario (i.e., single layer 

clothing, socks, and shoes), followed by increasing levels of risk mitigation such as personal 

protective equipment (PPE) and engineering controls (EC). In the case of triadimefon, 

exposure to pesticide handlers is likely during the occupational use of the pesticide in a 

variety of occupational environments. The anticipated use patterns and current labeling 

indicate several occupational exposure scenarios based on the types of equipment and 

techniques that can potentially be used for triadimefon applications. Based on the use 

patterns, twenty-seven major occupational handler exposure scenarios (non-seed treatment) 

were identified. In addition, six major exposure scenarios were identified for pine seed 

treatment. The following exposure scenarios were used to develop the risk assessment for 

occupational handlers. 

(Non-seed treatment) 

 Mixer/Loaders: 

 (1a) Liquid Formulations to support Aerial Applications (PHED) 

 (1b) Liquid Formulations to support Groundboom Applications (PHED) 

 (1c) Liquid Formulations to support LCO Handgun Applications (PHED) 

 (1d) Liquid Formulations to support Airblast Applications (PHED) 

 (2a) Wettable Powders to support Aerial Applications (PHED) 

 (2b) Wettable Powders to support Chemigation Applications (PHED) 

 (2c) Wettable Powders to support Groundboom Applications (PHED) 

 (2d) Wettable Powders to support LCO Handgun Applications (PHED) 

 (2e) Wettable Powders to support Airblast Applications (PHED) 

 (2f) Wettable Powders to support Rights-of-Way Applications (PHED) 

 (3a) Water Dispersible Granules to support Aerial Applications (PHED) 

 (3b) Water Dispersible Granules to support Chemigation Applications (PHED) 

 (3c) Water Dispersible Granules to support Groundboom Applications (PHED) 

 (3d) Water Dispersible Granules to support LCO Handgun Applications (PHED) 

 (4a) Loading Granulars to support Aerial Applications (PHED) 

 (4b) Loading Granulars to support Tractor Drawn Spreader Applications (PHED) 

 

 Applicators: 

 (5) Aerial Spray Applications (PHED) 

 (6) Aerial Granular Applications (PHED) 

 (7) Groundboom Spray Applications (PHED) 
32

 (8) Airblast Spray Applications (PHED) 

 (9) Handgun Spray Applications (PHED) 

 (10) Rights of Way Spray Applications (PHED) 

 (11) Tractor-Drawn Spreader Granule Applications (PHED) 

 

 Flaggers: 

 (12) Flagging for Aerial Spray Applications (PHED) 

 (13) Flagging for Aerial Granular Applications (PHED) 

 

 Mixer/Loader/Applicators: 

 (14) Liquid Formulations: Low Pressure Handwand Sprayer (ORETF) 

 (15) Wettable Powder Formulations: Low Pressure Handwand Sprayer (PHED) 

(16) Water Dispersible Granules with Low Pressure Handwand (using ORETF data 

for liquid formulations as a surrogate) 

 (17) Liquid Formulations: Handgun Sprayer (ORETF) 

 (18) Wettable Powders with a Handgun Sprayer (ORETF) 

 (19) Water Soluble Bags with Handgun Sprayer (ORETF) 

 (20) Dry Flowables Concentrates with a Handgun Sprayer (ORETF) 

 (21) Liquid Formulations: High Pressure Sprayer (PHED) 

 (22) Water Dispersible Granules: High Pressure Handwand (PHED: liquid 

 concentrates) 

 (23) Wettable Powders: High Pressure Handwand (PHED: liquid concentrates) 

 (24) Liquids with an Tree Injector (no data) 

 (25) RTU: Briquette (no data)

 (26) Liquid Formulations: Dip (no data) 

(27) Loading/Applying Granulars via Push Type Spreader (ORETF) 

 

(Pine seed treatment) 

(S-1) on-nursery loading/applying with hopper or planter box seed treatment, 

(S-2) on-nursery loading/planting previously treated seeds, 

(S-3) on-nursery loading/applying wettable powders using cement mixer equipment 

(using PHED mixing/loading WP data), 

(S-4) on-nursery loading/applying dry flowables using cement mixer equipment 

(using PHED mixing/loading DF data), 

 (S-5) on-nursery drying/raking/bagging treated seed, 

(S-6) loading and applying wettable powder formulations with commercial seedtreatment equipment, 

(S-7) commercial sewer stitching bags of seed, 

(S-8) bagging and otherwise handling treated seeds with commercial equipment, and 

(S-9) multiple commercial seed treatment activities. 

 c. Occupational Handler Risk Summary 

The Agency has determined that there are potential exposures to individuals who mix, 

load, apply, and otherwise handle triadimefon during the usual use patterns associated with 

the pesticide’s use. 
33

In all non-seed treatment scenarios, combined dermal and inhalation MOEs meet or 

exceed the level of concern of 100 at some level of risk mitigation (personal protective 

equipment or engineering controls). In the majority of scenarios where data are available, 

combined dermal and inhalation risks are not a concern at baseline (long-sleeve shirt, long 

pants, shoes, socks, no respirator) or baseline plus chemical-resistant gloves. However, there 

are risk concerns requiring additional dermal or inhalation protection (e.g. a respirator or 

engineering controls) for several of the scenarios involving mixing/loading/applying wettable 

powder (See Table 16). 

 In all the in-nursery seed treatment scenarios where data are available, combined 

dermal and inhalation MOEs meet or exceed the required level of concern of 100 at baseline 

or baseline plus chemical-resistant gloves. For commercial seed treatment, combined dermal 

and inhalation risks meet or exceed the required MOE of 100 with baseline PPE. 
34

Table 16. Combined Dermal plus Inhalation Handler Risks for Agricultural and Commercial Uses 

Combined MOEsi

Exposure 

Scenario 

Crop or 

Target 

App Rate 

(lb ai/acre)a

Area 

Treated 

Daily 

(acre)b

Baselinec

Dermal 

+ 

Baseline 

Inh 

Single 

layer w/ 

glovesd

Dermal + 

Baseline 

Inh 

Double 

layer w/ 

glovese

Dermal + 

Baseline 

Inh 

Single 

layer 

w/gloves 

Dermal + 

80% Rf Inh 

Single 

layer w/ 

gloves 

Dermal + 

90% Rg

Inh 

Double 

layer w/ 

gloves 

Dermal + 

80% R 

Inh 

Mixer/Loader

Mixing/Loading 

Liquid 

Concentrates for 

Injection 

ornamentals 

(shade trees, 

woody 

shrubs) 

0.000026 lb 

ai/inch of 

trunk 

inch of 

trunk No Data No Data No Data No Data No Data No Data 

 Christmas 

trees 0.25 350 30 60 61 250 

turf (sod 

farm) 

2.7 (except 

CA) 350 2.7 5.6 5.6 23 38 24 

Mixing/Loading 

Wettable 

Powders for 

Aerial 

Applications 

pine seedlings 0.5 350 15 30 30 130 

Mixing/Loading 

Wettable 

Powders for 

Chemigation 

Applications 

turf (sod 

farm) 

2.7 (except 

CA) 350 2.7 5.6 5.6 23 38 24 

azaleas 0.005 lb ai/gallon 16000 gallons 32 66 67 270 

turf (sod 

farm) 2.7 80 12 24 25 100 

Mixing/Loading 

Wettable 

Powders for 

Groundboom 

Applications turf (golf 

course) 2.7 40 24 49 49 200 
35

Combined MOEsi

Exposure 

Scenario 

Crop or 

Target 

App Rate 

(lb ai/acre)a

Area 

Treated 

Daily 

(acre)b

Baselinec

Dermal 

+ 

Baseline 

Inh 

Single 

layer w/ 

glovesd

Dermal + 

Baseline 

Inh 

Double 

layer w/ 

glovese

Dermal + 

Baseline 

Inh 

Single 

layer 

w/gloves 

Dermal + 

80% Rf Inh 

Single 

layer w/ 

gloves 

Dermal + 

90% Rg

Inh 

Double 

layer w/ 

gloves 

Dermal + 

80% R 

Inh 

Mixing/Loading 

Wettable 

Powders to 

Support Rightsof-way sprayer 

turf (golf 

course and 

sod farms) 

2.7 80 12 24 25 100 

Applicator

Christmas 

trees 0.25 350 No Data No Data No Data No Data No Data No Data 

turf (sod 

farm) 2.7 350 No Data No Data No Data No Data No Data No Data 

Applying Sprays 

via Aerial 

Equipment 

pine seedlings 0.5 350 No Data No Data No Data No Data No Data No Data 

Applying 

Granulars via 

Aerial 

Equipment 

turf (sod 

farm) 2.6 350 No Data No Data No Data No Data No Data No Data 

Mixer/Loader/Applicator

turf (golf 

course, sod 

farms) 

2.7 5 No Data 15 15 53 79 58 

Mixing/Loading /Applying Wettable 

Powders with Low Pressure 

Handwand 

(PHED) 

pine seedlings 0.5 5 No Data 78 81 290 
36

Combined MOEsi

Exposure 

Scenario 

Crop or 

Target 

App Rate 

(lb ai/acre)a

Area 

Treated 

Daily 

(acre)b

Baselinec

Dermal 

+ 

Baseline 

Inh 

Single 

layer w/ 

glovesd

Dermal + 

Baseline 

Inh 

Double 

layer w/ 

glovese

Dermal + 

Baseline 

Inh 

Single 

layer 

w/gloves 

Dermal + 

80% Rf Inh 

Single 

layer w/ 

gloves 

Dermal + 

90% Rg

Inh 

Double 

layer w/ 

gloves 

Dermal + 

80% R 

Inh 

Mixing/Loading

/Applying 

Liquids with an 

Injector 

ornamentals 

(shade trees, 

woody 

shrubs) 

0.000075 lb 

ai/1 inch of 

trunk 

circumfere

nce 

inch of 

trunk 

circumfe

rence 

No Data No Data No Data No Data No Data No Data 

Mixing/Loading

/Applying RTU 

Briquette 

pine seedlings 0.00019 lb ai/seedling seedlings No Data No Data No Data No Data No Data No Data 

pine seed 

(nurseries) 

0.0000625 

lb ai/gallon 

100 

gallons No Data No Data No Data No Data No Data No Data 

Mixing/Loading

/Applying Dip pineapple 

(post-harvest) 

0.0028 lb 

ai/gallon 

100 

gallons No Data No Data No Data No Data No Data No Data 

a Application rates are the maximum application rates determined from EPA registered labels for triadimefon. b Amount handled per day values are HED estimates of acres treated per day based on Exposure SAC SOP #9 “Standard Values for Daily Acres Treated in Agri

HED estimates. 

c Baseline = No gloves and no respirator (i.e., long sleeve shirt, long pants, shoes and socks. 

d Single layer w/gloves is baseline attire plus chemical-resistant gloves. e Double layer w/gloves is coveralls worn over long-sleeve shirt and long pants, plus chemical-resistant gloves (with headgear). 

f 80% Respirator is quarter-face dust/mist respirator (that provides an 80% protection factor). g 90% Respirator is half-face dust/mist respirator (that provides a 90% protection factor). h Engineering control is closed mixing/loading system, enclosed cab, or enclosed cockpit. 

i Combined MOEs =1/[(1/Dermal MOE) + (/Inhalation MOE)]
37

As noted above, there are no available data to assess the following: 1) 

mixing/loading/ applying liquids with a tree injector to ornamental trees and woody shrubs; 

2) mixing/loading/applying dips to pineapples (pre-plant and post-harvest) and pine seed 

(nursery applications); 3) drying/raking/bagging treated pine seed; and 4) ready-to-use (RTU) 

briquette applications to pine seedlings. Therefore, the Agency is requiring the use of gloves 

to mitigate potential dermal exposure for these uses described above. 

 d. Occupational Post-application Risk Summary 

Triadimefon is currently labeled for use on grapes, turf (including residential, golf 

course and sod farm turf), ornamentals, apples, pears, Christmas trees, pine seedlings, and 

raspberries. Because of the use pattern, a wide array of individuals can potentially be 

exposed by working in areas that have been previously treated. However, the registrant has 

agreed to voluntarily delete all uses on apples, pears, grapes, raspberries, and residential turf. 

The Agency has used the most up-to-date information available to complete the postapplication risk assessment for triadimefon. Several data gaps exist, such as a lack of 

triadimefon-specific post-application studies and lack of transfer coefficients for certain crop 

activities. However, the existing database is adequate to assess post-application risk. 

Occupational risks were calculated using a MOE, which is a ratio of the daily dose to 

the toxicological endpoint of concern. Post-application risks diminish over time because 

triadimefon residues eventually dissipate in the environment. Therefore, risks were 

calculated over time based on changing residue levels. Occupational post-application 

exposure and risk assessment for agricultural uses of triadimefon indicates that risks are not a 

concern at day 0 (i.e., 12 hours after application) for all use sites and all post-application 

activities. MOEs for occupational post-application risk range from 220 for transplanting, 

weeding (hand), harvesting (hand), and harvesting (mechanical) at the 2.7 lbs. ai/A rate on 

sod farms and golf course turf. 

 10. Human Incident Data 

 In evaluating incidents to humans, the Agency reviewed reports from the National 

Poison Control Centers (PCC), California Department of Pesticide Regulation (CDPR), the 

Agency’s Office of Pesticide Program’s Incident Data System (IDS), the National Pesticide 

Information Center (NPIC), the National Institute of Occupational Safety and Health’s 

Sentinel Event Notification System for Occupational Risks (NIOSH SENSOR) for poisoning 

incident data on triadimefon/triadimenol. 

 Data provided by the PCC reported nine incidents of occupational exposure to 

triadimefon and 46 non-occupational exposures from 1993 through 2003. Of the 46 nonoccupational exposures, 13 occurred in children under six years of age. Of the total 20 cases 

with medically determined outcome, 11 reported minor medical outcome. From a total of 55 

exposures to triadimefon, just four were seen in a health care facility and none required 

hospitalization. A review of symptoms revealed almost exclusively irritation effects 

(including rash and erythema) to skin, mouth, throat, and eyes. In addition, there were four 
38

cases reporting headache and two reported cough. No other significant symptoms were 

reported. 

 The majority of triadimefon incidents (92%) reported by CDPR occurred prior to 

1990. Most of the triadimefon cases (73%) involved use on grapes which is a labor intensive 

crop involving high exposure to foliar residues. Foliar residues accounted for half of the 

illnesses and nearly half of the systemic illnesses. Skin, eye irritation, and rash were among 

the most common topical symptoms. The most common systemic effects included nausea, 

headache, sneezing, congestion, difficulty breathing and other allergic-type reactions. In 

addition, there were three reports of vomiting. Furthermore, the registrant has voluntarily 

agreed to delete all food (apples, grapes, pears, and raspberries) uses. 

 Reports submitted to the IDS indicate incidents from various sources. The NPIC is a 

toll-free information service supported by OPP. A ranking of the top 200 active ingredients 

for which telephone calls were received during calendar years 1984-1991, inclusive has been 

prepared. The total number of calls was tabulated for the categories human incidents, animal 

incidents, calls for information, and others. Triadimefon was not reported on the list of the 

top 200 chemicals with incidents reported to NPIC. Triadimefon was associated with one 

case out of a total of 5,899 cases reported to NIOSH SENSOR between 1998 and 2003. 

However, this case was a duplicate of a CDPR case, which had already been reported. 

 Conclusion: Both California and Poison Control Center data show a pattern of 

irritative, but usually minor, symptoms from exposure to triadimefon. Irritation to skin, eyes, 

and respiratory passage occur readily among unprotected handlers (applicators and 

mixer/loaders) and among those who have substantial contact with foliage such as grape 

harvesters and tenders. Additionally, it should be noted that triadimefon is a skin sensitizer, 

and as such, may contribute to allergic-type reactions. Furthermore, the registrant has 

voluntarily agreed to delete all uses on apples, grapes, pears, and raspberries. 

B. Environmental Fate and Effects Risk Assessment 

Triadimefon has the following registered uses, which result in environmental 

exposures: applications to fruits (apples, grapes, pears, and raspberries) turf, pine seedlings, 

Christmas trees, and ornamentals. However, the registrant has agreed to voluntarily delete all 

use on apples, grapes, pears, raspberries, and residential turf. A summary of the Agency’s 

environmental risk assessment for triadimefon is presented below. More detailed 

information associated with the environmental risk from the use of triadimefon can be found 

in the Environmental Fate and Ecological Risk Assessment (Revised) for Triadimefon, dated 

January 19, 2006 and Response to Bayer Public Comments Regarding the Environmental 

Fate and Effects Division Triadimefon Risk Assessment, dated June 1, 2006. These 

documents may be accessed in the OPP Public Docket (docket number EPA-HQ-OPP-2005-

0258) at http://www.regulations.gov. 
39

 1. Environmental Fate and Transport 

Triadimefon is stable to hydrolysis but degrades by photolysis in water with a halflife of 7.6 hours. In aerobic sandy loam soil, parent triadimefon degraded with a half life of 

5.6 days, and in anaerobic sandy loam soil the half life was 23.1 days. In anaerobic aquatic 

environments, triadimefon had a half-life of 217 days. The primary degradate identified in 

environmental fate studies (aerobic/anaerobic soil and anaerobic aquatic) was triadimenol. 

The other degradates identified in these studies were: p-chlorophenol (photolysis water/soil), 

4-chlorophenoxy-1,2,4-triazol-1-yl-methane (aerobic soil), and 1H-1,2,4-triazole (aerobic 

soil). 

The environmental fate assessment was based on an evaluation of total triadimefon 

toxic residues, which includes both parent and the degradate triadimenol. Since 

approximately 75% of parent triadimefon degraded to triadimenol within 60 days postapplication, for the purpose of modeling, physical characteristics that reflected combined 

properties of both compounds in proper relative proportions were used. Thus, for example, 

the aerobic soil half-life for total residues used in modeling was 240 days. 

Both triadimefon and triadimenol were shown to be moderately soluble, and are 

therefore capable of being transported dissolved in water as surface runoff or as leachate to 

groundwater. The adsorption coefficients (Koc) for triadimefon and triadimenol were 387 

L/kgoc and 365 L/kgoc (average of four soils), respectively. Triadimenol appears to be even 

more prone to leaching than triadimefon. This may be due partly to its formation in the 

aerobic subsurface, where subsequent rain or irrigation events can leach it deeper into the 

soil. However, due to its moderate mobility and adsorption characteristics, triadimefon is 

capable of persisting and accumulating in a variety of environmental conditions. Therefore, 

triadimefon is likely to be of greater concern for surface water runoff issues, but triadimenol 

is of greater concern for groundwater and apt to be more persistent than parent triadimefon in 

most settings. 

 2. Ecological Exposure and Risk 

 To estimate potential ecological risk, EPA integrates the results of exposure and 

ecotoxicity studies using the risk quotient method. Risk quotients (RQs) are calculated by 

dividing estimated environmental concentrations (EECs), based on environmental fate 

characteristics and pesticide use data, by ecotoxicity values for various wildlife and plant 

species. RQs are then compared to levels of concern (LOCs), and when the RQ exceeds the 

level of concern for a particular category, the Agency presumes a risk of concern to that 

category. See Table 17 for the Agency’s LOCs. Risk characterization provides further 

information on potential adverse effects and the possible impact of those effects by 

considering the fate of the chemical and its degradates in the environment, organisms 

potentially at risk, and the nature of the effects observed. To the extent feasible, the Agency 

seeks to reduce environmental concentrations in an effort to reduce the potential for adverse 

effects to non-target organisms. 
40

Table 17. EPA’s Levels of Concern and Associated Risk Presumptions 

Risk Presumption LOC 

Terrestrial 

Animals

LOC 

Aquatic 

Animals

LOC 

Plants (Terrestrial/ 

Aquatic/Semi-Aquatic) 

Acute Risk - there is potential for acute 

risk. 

0.5 0.5 1 

Acute Endangered Species - endangered 

species may be adversely affected. 

0.1 0.05 1 

Chronic Risk - there is potential for 

chronic risk. 

1 1 N/A 

For a more detailed explanation of the ecological risks posed by the use of triadimefon, refer 

to the “Environmental Fate and Effects Division Revised Risk Assessment for Triadimefon”, 

dated January 19, 2006. 

a. Aquatic Organism Exposure and Risk 

 

 1) Fish, Invertebrate, and Aquatic Plant Toxicity 

Freshwater and Estuarine/Marine Fish

Toxicity studies conducted using technical triadimefon demonstrate that it is slightly 

to moderately toxic to freshwater fish under acute exposure with LC50 values ranging from 

4.1 ppm to 28 ppm (rainbow trout) and 10 ppm to 24.7 ppm (bluegill sunfish). Likewise, 

two freshwater toxicity studies were also conducted for the major triadimefon degradate, 

triadimenol. The freshwater fish acute toxicity values (LC50) for triadimenol indicate that 

triadimenol is slightly toxic on an acute basis. 

Tables 18 and 19 summarize the data that support the acute toxicity endpoints used in 

assessing the risks to freshwater fish. No triadimefon or triadimenol estuarine/marine fish 

acute toxicity tests were submitted to the Agency. 

Table 18. Acute Toxicity Endpoints for Freshwater Fish (Triadimefon) 

Test Species/ % a.i. 96-hr LC50

(ppm) 

Toxicity 

Classification MRID No. Author/Year 

Cold water fish (Rainbow 

trout, Oncorhynchus 

mykiss

96.8 4.1 Moderately toxic 43256201 

Bowers/1994 

Table 19. Acute Toxicity Endpoints for Freshwater Fish (Triadimenol) 

Test Species/ % a.i. 96-hr LC50

(ppm) 

Toxicity 

Classification MRID No. Author/Year 

Warm water fish 

(Bluegill sunfish, Lepomis 

macrochirus) 

92 14 Slightly toxic 071469 

Lamb/1981 
41

For chronic toxicity, a freshwater fish early life-stage test using technical triadimefon 

showed that the most sensitive species is the rainbow trout, with a NOAEL of 41 ppb (0.041 

ppm). However, no chronic freshwater fish toxicity data were available for the degradate 

triadimenol. In addition, no triadimefon or triadimenol estuarine/marine fish chronic toxicity 

tests were submitted. Table 20 summarizes the data for the chronic toxicity endpoints used 

in assessing the risks to freshwater fish. 

Table 20. Early Life-Stage Chronic Toxicity Endpoints for Freshwater Fish 

(Triadimefon) 

Group 

(Test Species) % a.i. NOAEL

(ppm) 

LOAEL 

(ppm) Endpoints Affected MRID No. Author/Year 

Cold water fish 

(Rainbow trout, 

Oncorhynchus 

mykiss) 

93 0.041 0.116 Growth 251243 

Carlisle/1983 

Freshwater and Estuarine/Marine Invertebrates 

Toxicity studies conducted using technical triadimefon demonstrate that it is slightly 

to moderately acutely toxic to freshwater invertebrates, with LC50 values ranging from 1.6 to 

11.3 ppm. Freshwater invertebrate acute toxicity tests were also performed for the degradate 

triadimenol, resulting in an LC50 value of 2.5 ppm (moderately toxic). Table 21 summarizes 

the data that support the acute toxicity endpoints used in assessing the risks to aquatic 

invertebrates. No triadimefon or triadimenol estuarine/marine invertebrate acute toxicity 

tests were submitted to the Agency. 

Table 21. Acute Toxicity Endpoints for Freshwater Invertebrates 

Test Species/ Flow-through % a.i. 48-hr LC50

(ppm) 

Toxicity 

Classification 

MRID No. 

Author/Year 

Triadimefon

Invertebrate (Waterflea, 

Daphnia magna) Tech. 1.6 Moderately toxic 

231311 

Lamb/1997 

Triadimenol

Invertebrate (Waterflea, 

Daphnia magna) 92 2.5 Moderately 

toxic 

071469 

Lamb/1981

A freshwater early life stage aquatic toxicity test using technical triadimefon is 

available for daphnia magna with a NOAEL of 0.052 ppm (decreased adult length). Table 22 

summarizes the data for the chronic toxicity endpoint used in assessing the risks to 

freshwater invertebrates. No triadimenol freshwater invertebrate chronic toxicity data was 

submitted, and no triadimefon or triadimenol estuarine/marine invertebrate chronic toxicity 

tests were submitted. 
42

Table 22. Early Life-Stage Chronic Toxicity Endpoints for Freshwater Invertebrates 

Group 

(Test Species) % a.i. NOAEL

(ppm) 

LOAEL 

(ppm) 

Endpoints 

Affected MRID No. Author/Year 

Triadimefon 

Invertebrate 

(Waterflea, 

Daphnia magna) 

94.2 0.052 0.119 Adult length 41922102 

Gagliano/1991 

Non-target Aquatic Plants

An aquatic plant toxicity study was performed for triadimefon on the technical 

formulated product on green algae, resulting in an EC50 value of 1.71 ppm. The EC50 value 

for triadimenol was 3.7 ppm. No studies were performed on vascular aquatic plant species. 

Table 23 summarizes the data for the plant toxicity endpoints used in assessing the risks to 

aquatic plants. 

Table 23. Toxicity Endpoints for Aquatic Plants (Nonvascular) 

Species % a.i. EC50 

(ppm) 

EC05 or 

NOAEC 

(ppm) 

MRID No. 

Author/Year 

Triadimefon 

Green algae 

Scenedesmus subspicatus 

91.5 1.71 0.1 00159558 

Heimbach/1985 

Triadimenol 

Green algae 

Scenedesmus subspicatus

94.9 3.7 0.32 266051 

Mobay/1986 

2) Fish and Invertebrate Exposure 

This assessment assumes exposure to both the parent triadimefon as well as 

triadimenol for aquatic organisms. OPP generally uses computer simulation models to 

estimate exposure of aquatic organisms, such as plants, fish, aquatic-phase amphibians, and 

invertebrates, to a pesticide. These models calculate estimated environmental concentrations 

(EECs) in surface water using laboratory data that describe the rate at which the pesticide 

breaks down and how it moves into the environment. The Pesticide Root Zone Model and 

Exposure Analysis Modeling System (PRZM-EXAMS) model is initially used to calculate 

high-end estimates of surface water concentrations of pesticide in a generic pond. This 

model was used to generate EECs of total triadimefon (parent + triadimenol) in surface 

water. The User’s Manual and PRZM-EXAMS model description can be consulted for 

additional information at: www.epa.gov/offefed1/models/water/index.htm. No EECs are 

generated in instances where no toxicity was observed at concentrations above the active 

ingredient’s water solubility or at or above the recommended limit concentration for a 

particular type of study. 

The Agency used PRZM-EXAMS (Exposure Analysis Modeling System) modeling 

to derive tier II estimated environmental concentrations (EECs) for triadimefon in surface 

water. Unlike the drinking water assessment described in the human health risk assessment 

section of this document, the ecological water resource assessment does not include the Index 
43

Reservoir (IR) and Percent-Crop Area (PCA) factor refinements. The IR and PCA factors 

represent a drinking water reservoir, not the variety of aquatic habitats, such as ponds 

adjacent to treated fields, relevant to a risk assessment for aquatic animals. The assumptions 

used represent pesticide transport in surface water in a standard pond (10,000-m2

 pond, 2-m 

deep), with the assumption that the small field (10-ha agricultural field) is cropped at 100%. 

Therefore, the EEC values used to assess exposure to aquatic organisms are not the same as 

the values used to assess human dietary exposure from drinking water sources. 

 Several scenarios chosen to represent different U.S. regions and uses were modeled 

for each use and can be found in the environmental fate and effects assessment for 

triadimefon. The turf scenarios gave the maximum EECs, and so were chosen for regulatory 

purposes. The EEC values used to assess exposure to aquatic organisms can be found in the 

Environmental Fate and Ecological Risk Assessment (Revised) for Triadimefon, dated 

January 19, 2006. 

3) Fish and Invertebrate Risk 

Fish, Aquatic Invertebrates, and Aquatic Plants 

There would be no LOC exceedances for fish, aquatic invertebrates, or aquatic nonvascular plants for Bayer’s newly proposed turf maximum application rate of 2 applications 

of 2.7 lbs. ai/A at 14 day intervals. There were no studies available to assess risk to aquatic 

vascular plants (See Table 24). 

 Table 24. Aquatic Organism RQ calculations

Crop Acute Risk Quotients Chronic Risk Quotients 

App. rate (# of 

apps., and 

interval between 

apps.) 

Peak 

EEC 

(ppb) 

Freshwate

r Fish 

LC50

=4100 

ppb 

Freshwater 

Invert. 

LC50 = 1600 

ppb 

Aquatic 

nonvascular 

plants 

EC50 = 

17000 

ppb 

60 

Day 

EEC 

21 

Day 

EEC 

Freshwat

er Fish 

NOEAC 

= 41 ppb 

Freshwater 

Invertebrate 

NOEAC = 

52 ppb 

FL turf 2.7 lbs. 

a.i./acre (2 app., 

14 day 

intervals) 

40.65 <LOC <LOC <LOC 27.2 33.36 < LOC < LOC 

4) Non-target Aquatic Plants 

Risks were below the Agency’s level of concern for non-target aquatic non-vascular 

plants. No toxicity data were available to assess risks to non-target aquatic vascular plants. 
44

b. Terrestrial Organism Exposure and Risk 

 

1) Bird and Mammal Toxicity 

Birds

 Triadimefon is classified as practically non-toxic to birds with acute oral LD50 values 

exceeding the highest dose tested (>4000 mg ai/kg bw) and (>2000 mg ai/kg bw) via an 8-

day and 14-day test, respectively. With dietary LC50 values between >4640 ppm to >10,000 

ppm triadimefon is classified as practically non-toxic on a subacute dietary basis. 

 Avian single dose oral toxicity studies were also performed on the major degradate 

triadimenol. The acute oral (LD50) toxicity of triadimenol to bobwhite quail exceeded the 

highest dose tested (>2000 mg ai/kg) (MRID 126276). Additionally, a triadimenol subacute 

dietary study was performed with mallard ducks, and no mortality or signs of toxicity were 

seen at any doses (LC50 >5000 ppm; MRID 00126277). The results of both studies 

demonstrate that triadimenol is practically nontoxic to birds on an acute oral and subacute 

dietary basis. Table 25 summarizes the data that support the acute and subacute toxicity 

endpoints used in assessing the risks to birds for both triadimefon and its degradate 

triadimenol. 

Table 25. Acute Toxicity to Birds

Endpoint Chemical Environment/

Species 

Toxicity Value 

Used in Risk 

Assessment 

Reference Toxicity 

Classification 

Triadimefon Bobwhite 

quail 

LD50 = >2000 

mg ai/kg bw 

MRID 

41895901 

Practically nontoxic Acute Toxicity 

to Birds 

Triadimenol Bobwhite 

quail 

LD50 = >2000 

mg ai/kg bw 

MRID 

071469 

Practically nontoxic 

Triadimefon Bobwhite 

quail 

LC50 = 8392 

ppm 

MRID 

00050066 

Practically nontoxic 

Subacute 

Toxicity to Birds 

Triadimenol Mallard duck LC50 >5000 

ppm 

MRID 

00126277 

Practically nontoxic 

 

For chronic toxicity, avian reproduction toxicity tests were performed using technical 

triadimefon resulting in a NOAEL of 20 ppm ai (bobwhite quail). In addition, avian 

reproduction toxicity tests were also performed for the degradate triadimenol with a NOAEL 

of 100 ppm ai (mallard duck). Table 26 summarizes the data for the chronic toxicity 

endpoints used in assessing the risks to birds. 

Table 26. Chronic Toxicity to Birds 

Species % a.i. NOAEL 

(ppm ai) 

LOAEL 

 (ppm ai) LOAEL Endpoints MRID No. Author/Year 

Triadimefon 

Northern 93 20 100 Eggs cracked, decrease in 110430 Lamb/1982 
45

bobwhite fertile eggs, decrease in 

viable embryos, hatchling, 

14-day old survivors 

Triadimenol 

Mallard duck 97 100 500 

Eggs laid, decrease in 

viability, hatchability, 14-

day survivors 

40283102 

Carlisle/1984 

 Mammals 

 Triadimefon is classified as slightly toxic to mammals on an acute basis with LD50

values of 1470 mg/kg (males) and 1090 mg/kg (females). Acute toxicity tests showed LD50

values of 689 mg/kg (males) and 752 mg/kg (females) for the degradate triadimenol, 

classifying it as slightly toxic to mammals (see Table 27). 

Table 27. Summary of Acute Toxicity Endpoints for Mammals 

Endpoint Chemical Species 

Toxicity 

Used in Risk 

Assessment 

(Most sensitive 

Endpoints) 

Reference: Classification 

Triadimef

on 

Rat LD50 = 1090 mg/kg 

(females) 

MRID 

00264276 

Acceptable 

Acute Toxicity 

to Mammals Triadimen

ol 

Rat LD50 = 689 mg/kg 

(males) 

MRID 

00125411 

Acceptable 

Chronic toxicity data for mammals from the 2-generation rat reproduction study 

testing triadimefon indicate decreased pup weights and viability in the F1 and F2 generations 

and decreased litter size in the F2 generation with an offspring NOAEL of 50 ppm ai. In 

addition, chronic toxicity tests for the degradate triadimenol showed decreased pup weights 

with a NOAEL of 100 ppm ai and a LOAEL of 500 ppm ai (see Table 28). 

Table 28. Summary of Chronic Toxicity Endpoints for Mammals 

Species Test Type/ 

Classification 

Toxicity Values Used 

in Risk Assessment Affected Endpoints MRID No. 

Triadimefon 

Laboratory Rat 

(Rattus norvegicus)

2-generation 

reproduction 

Offspring NOAEL = 

50 ppm 

Offspring LOAEL = 

1800 ppm 

Decreased pup 

weight and viability. 00155075 

92188019 

92188320 

Triadimenol 

Laboratory Rat 

(Rattus norvegicus)

2-generation 

reproduction 

Parental NOAEL = 

100 ppm 

Parental LOAEL = 

500 ppm 

Offspring NOAEL = 

Decreased body 

weights and weight 

gain 

Decreased pup 

00151248 
46

Species Test Type/ 

Classification 

Toxicity Values Used 

in Risk Assessment Affected Endpoints MRID No. 

100 ppm 

Offspring LOAEL = 

500 ppm 

weight 

 

 2) Bird and Mammal Exposure 

Pesticide residues on food items are estimated based on the assumption that terrestrial 

organisms are exposed to a single pesticide residue in a given exposure scenario. 

Application methods for liquid triadimefon formulations include ground spray, aerial spray, 

and chemigation. Additionally, granular triadimefon is broadcast on residential lawns and 

turf (no soil incorporation). 

The Agency assessed exposure to terrestrial organisms first predicting the amount of 

triadimefon residues found on animal food items and then using information on typical food 

consumption by various species of birds and mammals to determine the amount of pesticide 

consumed. Estimated exposure concentrations for terrestrial animals (via spray applications) 

were determined by using the standard screening-level exposure model, TREX (v.1.2) (US 

EPA, 2005), which calculates pesticide residues on each type of food item on a daily interval 

for one year. Also, registrant supported golf course use rates and application intervals were 

used (2 applications @ 2.7 lbs. ai/A). 

For a single application there is a linear relationship between the amount of pesticide 

applied and the amount of pesticide residue present on a given food item. These 

relationships for the various food items are determined from the Kenaga nomogram, which is 

a model developed by Hoerger and Kenaga (1972) and modified by Fletcher (1994). In 

addition to incorporating the nomogram relationship, TREX also includes pesticide 

degradation in the estimation of EECs. 

 3) Bird and Mammal Risk

Birds

There are acute and chronic LOC exceedances for birds. The turf maximum 

application rate of 2 applications of 2.7 lbs. ai/A at 14 day intervals results in acute RQ LOC 

exceedances that are 0.14 for short grass only and chronic RQ LOC exceedances that range 

from 4 to 57. Table 29 shows the avian acute and chronic risk quotients for turf use of 

triadimefon. An avian acute assessment was not conducted for granular applications because 

definitive avian LD50 values were not available for triadimefon (no mortalities or signs of 

toxicity were seen in the study at the highest exposure level). 
47

Table 29. Avian Dietary-Based Acute and Chronic RQs for turf uses of Triadimefon 

(based on NOAEC of 20 mg/kg diet) based on upper-bound Kenaga values. 

Use 

(Application Rate) 

Food Items Upper Bound 

EEC (mg/kg) 

Acute DietaryBased RQ 

(EEC/LC50) 

Chronic DietaryBased RQ 

(EEC/NOAEC) 

Short grass 1139 0.14 57 

Tall grass 522 0.06 26 

Broadleaf 

plants/small insects 641 0.08 32 

Turf (2.7 lbs. 

a.i./A, 2 

applications, 14 day 

interval) Fruits, pods, seeds, 

large insects 71 0.01 4 

Mammals

For spray application, there are mammalian acute LOC exceedances (LOC > 0.5) for 

small and medium (15 and 35g) mammals which consume short grass treated with 2 

applications @ 2.7 lbs. ai/A with a 14-day interval. Endangered species LOCs are exceeded 

(LOC> 0.1) for all weight classes of mammals assessed. Acute RQs are summarized below 

in Table 33. 

The predicted triadimefon granular EEC values resulting from residential application 

at a rate of 2.7 lbs. ai/A (2 applications, 14-day interval) is 28.12 mg/ft2 (See Table 30). 

Table 30. Mammalian Dose-based Acute RQs for turf uses of Triadimefon (based on 

Triadimenol LD50 of 689 mg/kg in rats) based on upper-bound Kenaga values. 

Spray Application 

Use Body Weight Mammalian Dose-based Acute Risk Quotients 

(g) 

Adjusted 

LD50 Short 

grass 

Tall 

grass 

Broadleaf 

plants/ small 

insects 

Fruits/pod

s/ large 

insects 

Seeds 

15 1514 0.72 0.33 0.40 0.04 0.01 

35 1225 0.61 0.28 0.34 0.04 0.01 

Turf (2.7 lbs. 

ai/A, 2 

applications, 14 

day interval) 1000 530 0.33 0.15 0.18 0.02 0.00 

Granular Application 

Use Body Weight 

(g) 

Mg a.i./sq 

ft Adjusted LD50 Risk Quotient 

15 28.12 1514 1.24 

35 28.12 1225 0.66 

Turf (2.7 lbs. 

ai/A, 2 

applications, 14 

day interval) 1000 28.12 530 0.05 

In addition, there are LOC exceedences of mammalian chronic risks ranging from 

1.42 to 23 for the turf maximum application rate of 2 applications of 2.7 lbs. a.i./A at 14 day 

intervals (See Table 31). 
48

Table 31. Mammalian Dietary-based Chronic RQs for selected uses of non-granular 

Triadimefon (based on triadimefon rat NOAEL of 50mg/kg diet) and upper-bound 

Kenaga values. 

Use Dietary-based Chronic Risk Quotients 

Short Grass Tall Grass Broadleaf plants Fruits/pods/ 

large 

insects/seeds 

Turf (2.7 lbs. ai/A, 2 

applications, 14 day interval) 22.78 10.44 12.81 1.42 

Additional/Potential Dietary Risks to Birds and Mammals

Based on the use of a fugacity-based (equilibrium partitioning) approach, an 

estimation of the concentration of triadimefon and its degradates in earthworms were 

calculated in order to determine the possible contribution of earthworm (and other terrestrial 

invertebrate) consumption to mammal and avian risk. The calculated earthworm tissue 

concentrations of triadimefon/triadimenol suggest that ingestion of earthworms by birds and 

mammals based on dietary dose (triadimefon NOAEC = 20 mg/kg diet and NOAEL = 2.5 

mg/kg bw, respectively) could be another exposure pathway contributing to chronic risk, 

although the low earthworm concentrations would necessitate consumption of a large number 

of worms. 

 4) Non-target Terrestrial Plants 

Non-target Terrestrial Plants 

 No guideline studies evaluating the toxicity of triadimefon to terrestrial plants have 

been submitted to the Agency. However, although several other studies within the Agency’s 

database were not suitable for use in determining toxicity endpoints, they can be interpreted 

qualitatively to demonstrate potential terrestrial plant risk from triadimefon. One such study 

is summarized below. 

 The regrowth of Kentucky bluegrass was inhibited following treatment of 

triadimefon. The same study showed a height decrease in kidney bean plants. Although the 

study did not provide adequate information to quantitatively calculate RQ values for nontarget terrestrial plants, the results suggest that triadimefon may have negative effects on both 

monocot and dicot non-target terrestrial plants. Please refer to the environmental fate and 

effects risk assessment for more detailed information. 

Based on the supported maximum 2 applications for the golf course use pattern for a 

maximum single application of 2.7 lbs. a.i./acre, there would be no LOC exceedances for 

non-vascular aquatic plants. 
49

5) Non-target Insects 

EPA currently does not quantify risks to terrestrial non-target insects; therefore, risk 

quotients are not calculated for these organisms. Based on the acute contact toxicity study to 

honeybees, the LD50 for triadimefon is >25 ug ai/bee (MRID 42307804), which classifies it 

as practically non-toxic to honeybees. No data were available for the degradate triadimenol.

 3. Ecological Incidents 

A review of the Ecological Incident Information System (EIIS) was completed on 

April 21, 2005. No incidents involving triadimefon or its metabolite triadimenol were 

reported. 

 4. Endangered Species 

The Agency’s screening level ecological risk assessment for endangered species 

results in the determination that triadimefon will have no direct acute effects on threatened 

and endangered freshwater fish, and freshwater aquatic invertebrates. However, the 

assessment indicates that triadimefon has the potential for causing risk to endangered birds, 

mammals, and non-target plants. Further, potential indirect effects to any species dependent 

upon a species that experiences effect cannot be precluded from use of triadimefon. These 

findings are based solely on EPA’s screening level assessment and do not constitute “may 

effect” findings under the Endangered Species Act. 

IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 

 A. Determination of Reregistration Eligibility and Tolerance Reassessment 

Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of 

relevant data concerning an active ingredient, whether or not products containing the active 

ingredient are eligible for reregistration. The Agency has previously identified and required 

the submission of the generic (i.e., active ingredient-specific) data required to support 

reregistration of products containing triadimefon as an active ingredient. The Agency has 

completed its review of these generic data, and has determined that the data are sufficient to 

support reregistration of all products containing triadimefon. 

The Agency has completed its assessment of the dietary, occupational, residential, 

and ecological risk associated with the use of pesticide products containing the active 

ingredient triadimefon. Based on a review of these data and on public comments on the 

Agency’s assessments for triadimefon, the Agency has sufficient information on the human 

health and ecological effects to make decisions as part of the tolerance reassessment process 

under FFDCA and reregistration process under FIFRA, as amended by FQPA. The Agency 

has determined that products containing triadimefon are eligible for reregistration provided 

that: (i) required product-specific data are submitted; (ii) risk mitigation measures outlined in 

this document are adopted (including requests for deletion of certain uses); and (iii) label 
50

amendments are made to reflect these measures. Label changes are described in Section V. 

Appendix A summarizes the uses of triadimefon that are eligible for reregistration. 

Appendix B identifies the generic data requirements that the Agency reviewed as part of its 

determination of reregistration eligibility of triadimefon, and lists the submitted studies that 

the Agency found acceptable. 

Based on its evaluation of triadimefon, the Agency has determined that triadimefon 

products, unless labeled and used as specified in this document, would present risks 

inconsistent with FIFRA. Accordingly, should a registrant fail to implement any of the risk 

mitigation measures identified in this document, the Agency may take regulatory action to 

address the risk concerns from the use of triadimefon. If all changes outlined in this 

document are implemented, then all current risks for triadimefon will be adequately 

mitigated for the purposes of this determination under FIFRA. Additionally, once an 

endangered species assessment is completed, further changes to these registrations may be 

necessary, as explained in Section IV..D..4 of this document. Once the uses that result in 

risks of concern are deleted and a cancellation order is issued, the Agency will take the 

appropriate regulatory action under FFDCA to revoke the associated tolerances. 

Triadimenol, a metabolite of triadimefon, is also a registered fungicide. Triadimenol 

was first registered after 1984 and is not subject to reregistration under the 1988 amendments 

to FIFRA. Triadimenol is, however, subject to tolerance reassessment under the FFDCA, as 

amended by FQPA. Based on its evaluation of combined exposures from the uses of 

triadimefon, triadimenol, and their metabolites, the Agency has determined that the 

tolerances for triadimefon and triadimenol are considered to be reassessed under FFDCA. 

 B. Public Comments and Responses 

Through the Agency’s public participation process, EPA worked extensively with 

stakeholders and the public to reach the regulatory decisions for triadimefon. EPA released 

its preliminary risk assessments for triadimefon and triadimenol for public comment on 

February 16, 2006, for a 60-day public comment period (Phase 3 of the public participation 

process). During the public comment period on the risk assessments, which closed on April 

17, 2006, the Agency received comments from a public citizen, nursery and forestry 

cooperatives, the U.S. Triazole Task Force, and the technical registrant Bayer CropScience. 

These comments in their entirety, responses to the comments, as well as the preliminary and 

revised risk assessments, are available in the public docket for triadimefon (EPA-HQ-OPP2005-0258) and for triadimenol (EPA-HQ-OPP-2006-0038) in the EPA’s electronic docket at 

http://www.regulations.gov. 

 C. Regulatory Position under the FFDCA 

 1. Food Quality Protection Act Findings 

a. “Risk Cup” Determination 
51

As part of the FQPA tolerance reassessment process, EPA assessed the risks 

associated with this pesticide. The Agency has determined that, if the mitigation described in 

this document is adopted and labels are amended, human health risks as a result of exposures 

to triadimefon and triadimenol are within acceptable levels. In other words, EPA has 

concluded that the tolerances for triadimefon and triadimenol will meet FQPA safety 

standards. In reaching this determination, EPA has considered the available information on 

the special sensitivity of infants and children, as well as exposures to triadimefon and 

triadimenol from all possible sources. Furthermore, if the registrant does not cancel the uses 

agreed to or make the mitigation changes necessary to meet the safety determination, the 

Agency will take the appropriate regulatory action. 

 b. Determination of Safety to U.S. Population

The Agency has determined that the established tolerances for triadimefon and 

triadimenol, with amendments and changes as specified in this document, will meet the 

safety standards under the FQPA amendments to section 408(b)(2)(D) of the FFDCA, and 

that there is a reasonable certainty no harm will result to the general population or any 

subgroup from the use of triadimefon and triadimenol. In reaching this conclusion, the 

Agency has considered all available information on the toxicity, use practices and exposure 

scenarios, and the environmental behavior of triadimefon and triadimenol and their free 

triazole degradates. 

 As discussed in Section III, the aggregate risks from triadimefon and triadimenol 

from food, drinking water, and residential exposure are not of concern, provided the 

mitigation measures described in this document are implemented through amendments to 

existing registrations. Furthermore, aggregate risks from the free triazoles (1,2,4-triazole, 

triazole acetic acid, and triazole alanine) are not of concern. The aggregate risk assessment 

for the free triazoles considers all currently registered uses of all triazole fungicides. 

 c. Determination of Safety to Infants and Children

EPA has determined that the established tolerances for triadimefon and triadimenol, 

with amendments and changes as specified in this document, will meet the safety standards 

under the FQPA amendments to section 408(b)(2)(C) of the FFDCA, that there is a 

reasonable certainty of no harm for infants and children. The safety determination for infants 

and children considers factors on the toxicity, use practices and environmental behavior 

noted above for the general population, but also takes into account the possibility of 

increased dietary exposure due to the specific consumption patterns of infants and children, 

as well as the possibility of increased susceptibility to the toxic effects of triadimefon and 

triadimenol residues in this population subgroup. 

 d. Endocrine Disruptor Effects

EPA is required under the FFDCA, as amended by FQPA, to develop a screening 

program to determine whether certain substances (including all pesticide active and other 

ingredients) “may have an effect in humans that is similar to an effect produced by a 
52

naturally occurring estrogen, or other endocrine effects as the Administrator may designate.” 

Following recommendations of its Endocrine Disruptor Screening and Testing Advisory 

Committee (EDSTAC), EPA determined that there was a scientific basis for including, as 

part of the program, the androgen and thyroid hormone systems, in addition to the estrogen 

hormone system. EPA also adopted EDSTAC’s recommendation to include evaluations of 

potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the extent that 

effects in wildlife may help determine whether a substance may have an effect in humans, 

FFDCA authority to require the wildlife evaluations. As the science develops and resources 

allow, screening of additional hormone systems may be added to the Endocrine Disruptor 

Screening Program (EDSP). 

e. Cumulative Risks 

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to 

establish, modify, or revoke a tolerance, the Agency consider “available information” 

concerning the cumulative effects of a particular pesticide’s residues and “other substances 

that have a common mechanism of toxicity.” Other substances are considered to account for 

the possibility that low-level exposures to multiple chemical substances that cause a common 

effect by a common mechanism could lead to the same adverse health effect as would a 

higher level of exposure to each individual substance. For the purposes of this regulatory 

decision, EPA has concluded that triadimefon and triadimenol do not share a common 

mechanism of toxicity with other substances. The Agency reached this conclusion after a 

thorough internal review and external review of the data supporting a common mechanism of 

toxicity for a number of chemical classes. For information regarding EPA’s efforts to 

determine which chemicals have a common mechanism of toxicity and to evaluate the 

cumulative effects of such chemicals, see the policy statements released by EPA’s Office of 

Pesticide Programs concerning common mechanism determinations and procedures for 

cumulating effects from substances found to have a common mechanism on EPA’s website 

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

2. Tolerance Summary for Triadimefon 

Tolerances of triadimefon in/on plant and livestock commodities (40 CFR § 180.410) 

are presently expressed in terms of residues of triadimefon and its metabolites containing 

chlorophenoxy and triazole moieties (expressed as the parent compound). 

 a. Tolerances Currently Listed Under 40 CFR §180.410 

 Tolerances are established for residues of triadimefon [1-(4-chlorophenoxy)-3,3-

dimethyl-1-(1H-1,2,4-triazol-1-yl)-2-butanone] and its metabolites containing chlorophenoxy 

and triazole moieties (expressed as the parent compound) in/on various plant and animal 

commodities [40 CFR §180.410]. The established tolerances for residues in plant and animal 

commodities [40 CFR §180.410(a)] range from 0.04 ppm (milk, hog, and poultry 

commodities) to 145 ppm (grass seed cleanings). A tolerance with regional registration is 

established for triadimefon and its metabolites in/on raspberries at 2.0 ppm [40 CFR 
53

§180.410(c)]. However, all triadimefon tolerances (except pineapple) will be proposed for 

revocation. 

 Residues of triadimenol (and its butanediol metabolite KWG 1342), from use of 

triadimenol per se, are regulated separately under 40 CFR §180.450. In addition, 40 CFR 

§180.3(d)(13) specifies that where tolerances are established for residues of both 1-(4- 

chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazole-1-yl)-2-butanone (triadimefon) and β-(4-

chlorophenoxy)-α-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol (triadimenol) including its 

butanediol metabolite, 1-(4-chlorophenoxy)-3,3-dimethyl-3-hydroxymethyl-1-(1H-1,2,4-

triazol-1-yl)-2-butanol (KWG1342), in or on the same raw agricultural commodity and its 

products thereof, the total amount of such residues shall not yield more residue than that 

permitted by the higher of the two tolerances. Currently, triadimefon and triadimenol do not 

share any uses, so 40 CFR §180.3(d)(13) should be deleted. A tolerance summary for 

triadimefon is presented in Table 32. 

Table 32. Tolerance Summary for Triadimefon 

Commodity 

Current 

Tolerance 

(ppm) 

Reassessed 

Tolerance (ppm) Comments 

Tolerances Established Under 40 CFR §180.410(a)

Apple 1 Revoke Bayer is voluntarily deleting this use. 

Apple, wet pomace and 

Apple, dry pomace

4 Revoke Bayer is voluntarily deleting this use. 

Barley, milled fractions 

(except flour) 4 Revoke Currently, Bayer does not have any registered uses of triadimefon on barley.

Beet, sugar 0.5 

Beet, sugar, tops 3 

Revoke Currently, Bayer does not have any registered 

uses of triadimefon on sugar beets.

Cattle, fat 1 Revoke 

Cattle, meat 1 Revoke 

Cattle, meat byproducts 1 Revoke 

Currently, Bayer does not have any registered 

uses of triadimefon on any cattle feed items. 

40 CFR §180.6(a)(3) It is not possible to 

establish with certainty whether finite residues 

will be incurred but there is no reasonable 

expectation of finite residues. 

Chickpea, seed 0.1 Revoke Currently, Bayer does not have any registered 

uses of triadimefon on chickpea plants.

Cucurbits 0.3 Revoke Currently, Bayer does not have any registered 

uses of triadimefon on chickpea plants.

Eggs 0.04 Revoke 

Currently, Bayer does not have any registered 

uses of triadimefon on any poultry feed items. 

40 CFR §180.6(a)(3) It is not possible to 

establish with certainty whether finite residues 

will be incurred but there is no reasonable 

expectation of finite residues. 

Goat, fat

1 Revoke 

Currently, Bayer does not have any registered 

uses of triadimefon on any goat feed items. 

40 CFR §180.6(a)(3) It is not possible to 
54

Commodity 

Current 

Tolerance 

(ppm) 

Reassessed 

Tolerance (ppm) Comments 

Goat, meat 1 Revoke 

Goat, meat byproducts 1 Revoke 

establish with certainty whether finite residues 

will be incurred but there is no reasonable 

expectation of finite residues.

Grape 1 Revoke Bayer is voluntarily deleting this use. 

Grape, wet pomace and 

Grape, dry pomace 3 

Grape, raisin, waste 7 

Revoke 

No longer considered significant livestock feed 

items.

Grass, forage 0.2 

Grass, seed screenings 145 

Grass, straw, grown for seed 105 

Revoke 

Currently, Bayer does not have any registered 

uses of triadimefon on pasture or rangeland.

Hog, fat

0.04 

Hog, meat 0.04 

Hog, meat byproducts 0.04 

Revoke 

Currently, Bayer does not have any registered 

uses of triadimefon on any hog feed items. 

40 CFR §180.6(a)(3) It is not possible to 

establish with certainty whether finite residues 

will be incurred but there is no reasonable 

expectation of finite residues.

Horse, fat 1 

Horse, meat 1 

Horse, meat byproducts 1 

Revoke 

Currently, Bayer does not have any registered 

uses of triadimefon on any horse feed items. 

40 CFR §180.6(a)(3) It is not possible to 

establish with certainty whether finite residues 

will be incurred but there is no reasonable 

expectation of finite residues.

Milk 0.04 

Revoke Currently, Bayer does not have any registered 

uses of triadimefon on any cattle feed items. 

40 CFR §180.6(a)(3) It is not possible to 

establish with certainty whether finite residues 

will be incurred but there is no reasonable 

expectation of finite residues.

Nectarine 4 Revoke Currently, Bayer does not have any registered 

uses of triadimefon on nectarine.

Pear 1 Revoke Bayer is voluntarily deleting this use. 

Pineapple, fresh 3 2 

Re-evaluation of data from field trials shows 

lower residues are expected. 

[Pineapple]

Poultry, fat 0.04 

Poultry, meat 0.04 

Poultry, meat byproducts 0.04 

Revoke 

Currently, Bayer does not have any registered 

uses of triadimefon on any poultry feed items. 

40 CFR §180.6(a)(3) It is not possible to 

establish with certainty whether finite residues 

will be incurred but there is no reasonable 

expectation of finite residues.
55

Commodity 

Current 

Tolerance 

(ppm) 

Reassessed 

Tolerance (ppm) Comments 

Raspberry 2 Revoke 

Bayer is voluntarily deleting this use. 

40 CFR §180.410(c) A tolerance with regional 

registration is established for triadimefon and its 

metabolites in/on raspberries. 

Sheep, fat 

1 

Sheep, meat 1 

Sheep, meat byproducts 1 

Revoke 

Currently, Bayer does not have any registered 

uses of triadimefon on any sheep feed items. 

40 CFR §180.6(a)(3) It is not possible to 

establish with certainty whether finite residues 

will be incurred but there is no reasonable 

expectation of finite residues.

Wheat, forage 15 

Wheat, grain 1 

Wheat, milled fractions 

(except flour) 4 

Wheat, straw 5 

Revoke 

Currently, Bayer does not have any registered 

uses of triadimefon on wheat.

 

 b. Codex Harmonization 

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

The Codex Alimentarius Commission (Codex) has established several MRLs for 

triadimenol in/on various raw agricultural commodities. The Codex MRLs are expressed in 

terms of triadimenol per se. The MRLs have been established to accommodate triadimenol 

residues resulting from the use of triadimefon and/or triadimenol. Compatibility cannot be 

achieved with the Codex MRLs because these levels are expressed in terms of triadimenol 

only; the U.S. tolerances for plant commodities are expressed in terms of triadimenol, KWG 

1342, and KWG 1732 in/on cereal grains and cotton and triadimenol and KWG 1342 in/on 

bananas.. 

 c. Residue Analytical Methods – Plants/Livestock 

The reregistration requirements for residue analytical methods are fulfilled. Adequate 

methods are available for data collection and for the enforcement of tolerances for residues of 

triadimefon per se in/on plant commodities. Since there is no reasonable expectation of 

residues in poultry, enforcement methods for the determination of triadimefon residues in 

livestock commodities are not needed. 

Plant Commodities. Two methods of gas chromatography with mass spectrometry 

detection (GC/MS) are listed in the Pesticide Analytical Manual (PAM Vol. II) for 

enforcement of tolerances in plant and livestock commodities. The methods use a single 

moiety detection in which residues are converted to p-dichlorophenol, derivatized with 

dinitrofluorobenzene, and reported as triadimefon equivalents. The GC/MS method is no 
56

longer adequate due to the recommended tolerance expression revisions. However, a GC 

method using a nitrogen phosphorus detector (NPD; Report No. 80488) is available for 

determination of residues of triadimefon, triadimenol, KWG 1323, and KWG 1342, and it is 

adequate for the enforcement of a pineapple tolerance. The reported method limit of 

quantitation (LOQ) is 0.01 ppm for each analyte. The limit of detection (LOD) was not 

reported. 

Livestock Commodities. The Pesticide Analytical Manual (PAM) Vol. II lists the two 

GC/MS methods described above (Methods I and II) for the determination of triadimefon and 

its free and conjugated metabolites in livestock commodities. Method I (Report No. 69531) 

is appropriate for livestock tissues and milk and Method II (Report No. 80265) is appropriate 

for livestock tissues and eggs. The reported LOQ is 0.05 and the LOD is 0.01 ppm for both 

methods. 

Multiresidue Methods. The 10/99 FDA PESTDATA database (PAM Volume I, 

Appendix I) indicates that triadimefon is completely recovered (>80%) using Multiresidue 

Methods Section 302 (Luke Method; Protocol D); recovery of triadimefon is small (<50%) 

using Multiresidue Methods Sections 303 (Mills, Onley, and Gaither; Protocol E, nonfatty) 

and 304 (Mills, fatty food). Triadimefon metabolites triadimenol and KWG 1323 are 

completely recovered using Section 302. Triadimenol, KWG 1323, and metabolite KWG 

1732 are not recovered using Sections 303 and 304. 

 3. Tolerance Summary for Triadimenol 

 The current tolerance expression for residues of triadimenol resulting from direct 

application to primary crops is adequate. The Agency has determined that the tolerance 

expression for residues in/on cereal grains (barley, corn, oats, rye, and wheat) and cotton 

commodities should include only triadimenol and its metabolites KWG 1342, and KWG 

1732. However, the tolerance expression for residues in/on bananas should include only 

triadimenol and its metabolite KWG 1342. A summary of triadimenol tolerance 

reassessments is presented in Table 33. 

 

 a. Tolerances Currently Listed Under 40 CFR §180.450

Tolerances are established for residues of triadimenol and its butanediol metabolite, 

4-(4-chlorophenoxy)-2,2-dimethyl-4-(1H-1,2,4-triazol-1-yl)-1,3-butanediol (calculated as 

triadimenol) in/on various plant commodities. The established tolerances in plant 

commodities range from 0.01 (sorghum grain and fodder) to 2.5 ppm (green forage of oats, 

rye, and wheat). Tolerances are currently established for residues of triadimenol and its 

metabolites containing the chlorophenoxy moiety (calculated as triadimenol) in livestock 

commodities at 0.01 ppm (milk and poultry commodities) and 0.1 ppm (fat, meat, and meat 

byproducts of cattle, goats, hogs, horses, and sheep). 

 

Tolerances Needed Under 40 CFR §180.450(a):

Triadimenol is registered for use on barley, corn, cotton, oats, rye, sorghum, wheat, 
57

and bananas as an import tolerance only; however, there are no existing tolerances associated 

with barley (hay), oat (hay), wheat (hay), and cotton (gin byproducts). Therefore, tolerances 

will need to be established for these crops. 

Tolerances Under 40 CFR §180.450(b):

The reregistration requirements for data depicting the magnitude of triadimenol 

residues of concern in meat, milk, poultry, and eggs have been fulfilled. Acceptable 

ruminant and poultry feeding studies have been submitted and evaluated. Triadimenol is not 

registered for use as a direct livestock treatment. The nature of the residue in livestock is 

adequately defined for the current uses. The Agency has concluded that the supported uses 

on barley, corn, cotton, oats, rye, and wheat result in a 40 CFR §180.6(a)(3) situation for 

ruminant commodities (i.e., there is no reasonable expectation of finite residues in ruminant 

commodities). Therefore, additional data on the transfer of residues to meat, milk, poultry, 

and eggs are not required and all tolerances for triadimenol residues in livestock commodities 

should be revoked pending results from the requested corn and wheat metabolism studies. If, 

however, foliar uses or registration on additional major livestock feed items are requested, 

then triazole and phenyl-labeled livestock metabolism studies would be required. Such data 

may, in turn, trigger the need for magnitude of the residue (feeding) studies in livestock. 

Table 33. Tolerance Summary for Triadimenol 

Commodity Current Tolerance 

(ppm) 

Tolerance 

Reassessment (ppm)

Comment/ 

[Correct Commodity Definition] 

Tolerances Established Under 40 CFR §180.450(a) 

Banana (Whole)1 0.2 0.2 

Barley, grain 0.05 TBD2 

Barley, straw 0.2 TBD2

Corn, forage 0.05 TBD2 [Corn, field, forage] 

[Corn, sweet, forage]

Corn, fresh (including 

sweet), (K+CWHR) 0.05 TBD2

[Corn, sweet, K+CWHR] 

Corn, grain 0.05 TBD2 [Corn, field, grain] 

[Corn, pop, grain] 

Corn, stover 0.05 TBD2

[Corn, field, stover] 

[Corn, pop, stover] 

[Corn, sweet, stover] 

Cotton, forage 0.02 Revoke No longer considered a significant 

livestock feed item. 

Cotton, undelinted seed 0.02 TBD2

Oat, grain 0.05 TBD2

Oat, forage 2.5 TBD2

Oat, straw 0.2 TBD2

Rye, forage 2.5 TBD2

Rye, grain 0.05 TBD2

Rye, straw 0.1 TBD2
58

Commodity Current Tolerance 

(ppm) 

Tolerance 

Reassessment (ppm)

Comment/ 

[Correct Commodity Definition] 

Tolerances Established Under 40 CFR §180.450(a) 

Sorghum, forage, hay 0.05 Revoke Use is not being supported. 

Sorghum, grain 0.01 Revoke Use is not being supported. 

Sorghum, grain, stover 0.01 Revoke Use is not being supported. 

Wheat, forage 2.5 TBD2

 

Wheat, grain 0.05 TBD2

 

Wheat, straw 0.2 TBD2

 

Tolerances Established Under 40 CFR §180.450(b)

Cattle, fat 0.1 

Cattle, meat 0.1 

Cattle, meat byproducts 0.1 

Revoke 

Available data indicate that 

tolerances for cattle commodities 

are not required. 

Egg 0.01 Revoke Available data indicate that a 

tolerance for egg is not required. 

Goat, fat 0.1 

Goat, meat 0.1 

Goat, meat byproducts 0.1 

Revoke 

Available data indicate that 

tolerances for goat commodities 

are not required. 

Hog, fat 0.1 

Hog, meat 0.1 

Hog, meat byproducts 0.1 

Revoke 

Available data indicate that 

tolerances for hog commodities 

are not required. 

Horse, fat 0.1 

Horse, meat 0.1 

Horse, meat byproducts 0.1 

Revoke 

Available data indicate that 

tolerances for horse commodities 

are not required. 

Milk 0.01 Revoke Available data indicate that a 

tolerance for milk is not required. 

Poultry, fat 0.01 

Poultry, meat 0.01 

Poultry, meat byproducts 0.01 

Revoke 

Available data indicate that 

tolerances for poultry 

commodities are not required. 

Sheep, fat 0.1 

Sheep, meat 0.1 

Sheep, byproducts 0.1 

Revoke 

Available data indicate that 

tolerances for sheep commodities 

are not required. 

Tolerances T Be Proposed Under 40 CFR §180.450(a)

Barley, hay None established TBD2

Cotton, gin byproducts None established TBD2 

Oat, hay None established TBD2 

Wheat, hay None established TBD2 

1

40 CFR §180.450(a) states that there are no U.S. registrations for bananas (whole). 

2

TBD = To be determined. Additional data are required. Note that while additional data are needed, there are no 

dietary risks associated with these tolerances and EPA considers them reassessed. 

 D. Regulatory Rationale under FIFRA 
59

The Agency has determined that triadimefon is eligible for reregistration, in 

compliance with FIFRA, and the associated tolerances are considered reassessed, provided 

that: 1) required product-specific and generic data are submitted; 2) risk mitigation measures 

(including requests to delete certain uses) outlined in this document are adopted; and 3) label 

amendments are made to reflect these measures. As stated above, the Agency will take steps 

to revoke the tolerances associated with the uses that are being deleted. 

Risks for currently registered uses of triadimenol are below the Agency’s level of 

concern, and no further mitigation is required. The tolerances for triadimenol are considered 

reassessed. Product-specific and generic data are required to be submitted, as specified in 

section V. 

The following is a summary of the rationale for managing risks associated with the 

use of triadimefon. Where labeling revisions are required, specific language is set forth in 

the summary tables of Chapter V of this document. 

 1. Human Health Risk Management 

a. Dietary (Food and Water) Risk Mitigation 

 Bayer, the sole technical registrant, has agreed to voluntarily delete all triadimefon 

food uses, except for pre-plant and post-harvest use on pineapples. Food uses to be deleted 

include apples, pears, grapes, and raspberries (in both commercial and residential settings). In 

order to reduce potential drinking water exposure to triadimefon, use on turf will be restricted 

to golf courses and sod farms, only, with a maximum single application rate of 2.7 lbs ai/A, 

and a maximum yearly rate of 5.4 lbs ai/A. With the above use deletions and restrictions, 

aggregate (food and water) risks are below the Agency’s level of concern. 

 b. Residential Risk Mitigation 

The following residential uses will remain as labeled use sites for triadimefon: 

• Outdoor ornamental flowers, shrubs, and trees; 

• Greenhouse ornamental flowers, shrubs, and trees. 

Bayer, the sole technical registrant, has agreed to request voluntary deletions of the 

residential turf use to address post-application and aggregate risks to toddlers. In addition, a 

17-day post-application, pre-harvest interval is required for sod farm turf, to address potential 

risks to toddlers exposed to sod farm turf transplanted to a residential setting. 

In order to address risks to residential handlers making applications to ornamentals, 

the following mitigation measures are required: 

• Package all wettable powder products in water-soluble bags; 

• Prohibit application with hose-end sprayers in residential greenhouses; 
60

• Reduce the application rate for all outdoor ornamental applications to a maximum of 

0.0025 lbs ai/gallon (for certain use sites, rates will remain lower than this 

maximum). 

Currently, the number of applications that can be made to golf course turf is not 

specified on product labels. Golf course use will be restricted to a maximum single 

application rate of 2.7 lbs ai/A, and a maximum yearly rate of 5.4 lbs ai/A. Although 

aggregate risks to golfers (youths and adults) do not currently exceed the Agency’s level of 

concern, this mitigation measure will further reduce exposure to golfers. 

c. Occupational Risk Mitigation 

The following commercial and agricultural uses will remain as labeled use sites for 

triadimefon: 

• Golf course turf 

• Sod farm turf 

• Outdoor ornamental flowers, shrubs, and trees 

• Greenhouse ornamental flowers, shrubs, and trees 

• Roses 

• Azaleas, for control of pine-twisting rust only 

• Pines, including Christmas trees 

• Pine seedlings 

• Pine seed (in-nursery and commercial) 

• Pineapples (pre-plant and post-harvest dip) 

Bayer, the sole registrant has requested that use on apples, pears, grapes, raspberries, 

and all turf other than golf course and sod farm turf be voluntarily deleted, reducing handler 

exposure. For golf courses and sod farms, a maximum single application rate of 2.7 lbs ai/A, 

and a maximum yearly rate of 5.4 lbs ai/A are required, further reducing handler exposure. 

Golf course applications will be restricted to turf less than 2.5 inches in height, which will 

limit application to golf course roughs. 

In order to address risks to occupational handlers mixing, loading, and applying 

triadimefon, the mitigation listed below is required: 

(1) Require all wettable powder products to be packaged in water-soluble bags (an 

engineering control). 

(2) Require closed cockpits for aerial applications. 

(3) Require chemical-resistant gloves for occupational handlers performing the following 

activities: 

• Mixing and loading all formulations (liquids, wettable powders, dry flowables) 

• Loading granulars; 
61

• Making applications with handheld equipment; 

• Any activities which involve contact with treated seed (including drying, raking, 

bagging, and sewing bags); 

• Mixing, loading, and applying when using a tree-injection unit; 

• Applying a ready-to-use briquette to pine seedlings. 

(4) Require both chemical resistant gloves and a chemical resistant apron for occupational 

handlers performing the following activities: 

• Dipping pineapples (pre-plant, and post-harvest); 

• Dipping pine seed (for on-nursery applications). 

With the above engineering controls and personal protective equipment, risks to 

residential handlers are below the Agency’s level of concern. 

d. Aggregate Risk Mitigation for Triazole Metabolites 

Acute, short- and intermediate-term, and chronic aggregate risks for degradates 1,2,4-

triazole, triazole alanine, and triazole acetic acid are below the Agency’s level of concern. 

The Agency considered the contribution of acute and chronic dietary risks from food and 

drinking water as well as residential handler and post-application exposures in the aggregate 

risk assessment for the free triazoles. Therefore, no further mitigation is necessary at this 

time. 

 

2. Environmental Risk Mitigation 

A number of the mitigation measures described above will reduce exposure and risks 

to mammals and birds. These include: 

• Deleting all outdoor food uses of triadimefon (pears, apples, grapes, and raspberries); 

• Limiting turf application rates to a maximum single application rate of 2.7 lbs ai/A, 

and a maximum yearly rate of 5.4 lbs ai/A (reduced from no limit on the number of 

applications); 

• Prohibiting use on residential turf (only application to golf course and sod farm turf 

will continue); 

• Limiting golf course applications to turf that is less than 2.5 inches in height (this will 

reduce application to golf course roughs, which are usually 3 or more inches in 

height). 

 3. Other Labeling 

In order to be eligible for reregistration, various use and safety information will be 

required in the labeling of all end-use products containing triadimefon. For the specific 

labeling statements and a list of outstanding data, refer to Section V of this RED document. 

 4. Endangered Species Program 
62

The Agency’s screening level ecological risk assessment for endangered species 

results in the determination that triadimefon will have no direct acute effects on threatened 

and endangered freshwater fish, and freshwater aquatic invertebrates. However, the 

assessment indicates that triadimefon has the potential for causing acute risk to endangered 

birds, mammals, and non-vascular aquatic plants. Chronic RQs for endangered mammals 

exceed the level of concern at all application rates modeled. Chronic RQs for endangered 

birds also exceed the level of concern. No data are available to assess the risks to 

estuarine/marine invertebrates, estuarine/marine fish, vascular aquatic plants, and terrestrial 

plants. Therefore, risks cannot be precluded on these species at this time. 

Further, potential indirect effects to any species dependent upon a species that 

experiences effect cannot be precluded from use of triadimefon. These findings are based 

solely on EPA’s screening level assessment and do not constitute “may effect” findings 

under the Endangered Species Act. 

The Agency has developed the Endangered Species Protection Program to identify 

pesticides whose use may cause adverse impacts on endangered and threatened species, and 

to implement mitigation measures that address these impacts. The Endangered Species Act 

requires federal agencies to ensure that their actions are not likely to jeopardize listed species 

or adversely modify designated critical habitat. To analyze the potential of registered 

pesticide uses that may affect any particular species, EPA uses basic toxicity and exposure 

data developed for the REDs and considers ecological parameters, pesticide use information, 

geographic relationship between specific pesticide uses and species locations, and biological 

requirements and behavioral aspects of the particular species. This analysis will consider the 

risk mitigation measures that are being implemented as a result of this regulatory decision. 

 Following this future species-specific analysis, a determination that there is a 

likelihood of potential impact to a listed species or its critical habitat may result in: 

limitations on the use of triadimefon; other measures to mitigate any potential impact; or 

consultations with the Fish and Wildlife Service or the National Marine Fisheries Service as 

necessary. If the Agency determines that use of triadimefon “may affect” listed species or 

their designated critical habitat, EPA will employ the provisions in the Services regulations 

(50 CFR Part 402). Until that species-specific analysis is completed, the risk mitigation 

measures being implemented through this RED will reduce the likelihood that endangered 

and threatened species may be exposed to triadimefon at levels of concern. EPA is not 

requiring specific triadimefon label language at the present time relative to threatened and 

endangered species. If, in the future, specific measures are necessary for the protection of 

listed species, the Agency will implement them through the Endangered Species Protection 

Program. 

V. What Registrants Need to Do 

The use of currently registered products containing triadimefon in accordance with 

approved labeling will not pose unreasonable risks or adverse effects to humans or the 

environment provided that the risk mitigation measures and label changes (including use 
63

deletions) outlined in this document are implemented. Therefore, all remaining uses of these 

products are eligible for reregistration. These products will be reregistered once the required 

confirmatory generic data, product specific data, CSFs, and revised labeling are received and 

accepted by EPA. Products that contain other ingredients in addition to triadimefon will be 

reregistered when all of their other active ingredients are also reregistered. 

A. For triadimefon technical grade active ingredient products, the registrant 

needs to submit the following items: 

Within 90 days from receipt of the generic data call in (DCI): 

 1. Completed response forms to the generic DCI (i.e., DCI response form 

and requirements status and registrant’s response form); and 

 2. Any time extension and/or waiver requests with a full written 

justification. 

Within the time limit specified in the generic DCI: 

 1. Citations of any existing generic data that address data requirements or 

submit new generic data responding to the DCI. 

Please contact John W. Pates, Jr. at (703) 308-8195 with questions regarding generic 

reregistration. 

By U.S. Mail: By express or courier service: 

Document Processing Desk (DCI/SRRD) Document Processing Desk (DCI/SRRD) 

John W. Pates, Jr. John W. Pates, Jr. 

U.S. EPA (7508P) Office of Pesticide Programs (7504P) 

1200 Pennsylvania Ave., NW Room S-4900 

Washington, DC 20460 One Potomac Yard 

 Arlington, VA 22202 

B. For end-use products containing the active ingredient triadimefon, the registrant 

needs to submit the following items for each product: 

Within 90 days from the receipt of the product-specific data call-in (PDCI): 

(1) completed response forms to the PDCI (i.e., PDCI response form and 

requirements status and registrant’s response form); and 

(2) any time extension or waiver requests with a full written justification. 

Within eight months from the receipt of the PDCI: 

 (1) two copies of the confidential statement of formula (EPA Form 8570-4); 

 
64

(2) a completed original application for reregistration (EPA Form 8570-1). 

Indicate on the form that it is an “application for reregistration”; 

(3) five copies of the draft label, incorporating all label amendments outlined in 

Table 33 of this document; 

(4) a completed form certifying compliance with data compensation requirements 

(EPA Form 8570-34); 

(5) if applicable, a completed form certifying compliance with cost share offer 

requirements (EPA Form 8570-32); and 

(6) the product-specific data responding to the PDCI. 

Please contact Veronica Dutch at (703) 308-8047 with questions regarding product 

reregistration and/or the PDCI. All materials submitted in response to the PDCI should be 

addressed: 

By US mail: By express or courier service only:

Document Processing Desk (PDCI/PRB) Document Processing Desk (PDCI/PRB) 

Veronica Dutch Veronica Dutch 

US EPA (7508P) Office of Pesticide Programs (7504P) 

1200 Pennsylvania Ave., NW Room S-4900 

Washington, DC 20460 One Potomac Yard 

 Arlington, VA 22202 

A. Manufacturing Use Products

1. Generic Data Requirements for Triadimefon

The generic data base supporting the reregistration of triadimefon for the above 

eligible uses has been reviewed and determined to be substantially complete. However, the 

following data requirements are necessary to confirm the reregistration eligibility decision 

documented in this RED: 

Human Health Effects

Guideline Study Name New OPPTS 

Guideline No. 

Old Guideline No.

Developmental Neurotoxicity Study (DNT) 870.6300 83-6 

Ecological Effects

Guideline Study Name New OPPTS 

Guideline No. 

Old Guideline No.

Estuarine/Marine Mollusk EC50 850.1025 72-3 B 

Estuarine/Marine Shrimp EC50 850.1035 72-3 C 

Estuarine/Marine Fish LC50 850.1075 72-3 A 
65

Seedling Emergence 850.4225 123-1 A 

Vegetative Vigor 850.4250 123-1 B 

Aquatic Vascular Plant Growth 850.4400 123-2 

 2. Labeling for Manufacturing-Use Products

To ensure compliance with FIFRA, manufacturing-use product (MUP) labeling 

should be revised to comply with all current EPA regulations, PR Notices, and applicable 

policies. The MUP labeling should bear the labeling contained in the labeling table, which 

will be issued separately. 

 B. End-Use Products 

 1. Additional Product-Specific Data Requirements 

Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed productspecific data regarding the pesticide after a determination of eligibility has been made. The 

Registrant must review previous data submissions to ensure that they meet current EPA 

acceptance criteria and if not, commit to conduct new studies. If a registrant believes that 

previously submitted data meet current testing standards, then the study MRID numbers 

should be cited according to the instructions in the Requirement Status and Registrants 

Response Form provided for each product. 

A product-specific data call-in, outlining specific data requirements, accompanies this 

RED. 

 2. Labeling for End-Use Products

Labeling changes are necessary to implement measures outlined in Section IV above. 

Specific language to incorporate these changes is specified in Table 34. 

 C. Data Requirements for Triadimenol 

There are data that must be submitted to support the continuing registration of 

triadimenol. These data are not expected to change the regulatory conclusions for triadimenol 

described in this document. A generic DCI will be issued and will require development and 

submission of these listed data in order to confirm the conclusions outlined in this document. 

Product Chemistry

Guideline Study Name New OPPTS 

Guideline No. 

Old Guideline No.

Stability 830.6313 63-13 

pH ( H20 solutions) 830.7000 63-12 

Ultraviolet/visible Absorption 830.7050 None 

Partition Coefficient (N-octanol/water) 

830.7550 

830.7560 

OR 

63-11 
66

Guideline Study Name New OPPTS 

Guideline No. 

Old Guideline No.

830.7570 

Water Solubility 

830.7840 

OR 

830.7860 

63-8 

Residue Chemistry

• Separate metabolism studies with triazole-14C and phenyl-14C labeled triadimenol 

applied as a seed treatment to wheat and corn must be conducted to confirm residues 

of concern.

• Storage stability data for triadimenol, KWG 1342, and KWG 1732 in/on field corn, 

sweet corn, cotton, and wheat processed commodities are required pending the results 

from the requested metabolism studies. Storage stability data for KWG 1732 in/ on 

wheat forage, hay, and straw are required pending the results from the requested 

metabolism studies.

• Crop field trial data depicting residues of triadimenol, KWG 1342, and KWG 1732 

in/on field corn (forage, grain, stover), sweet corn (forage, kernel plus cob with husks 

removed, grain, and stover), cotton (undelinted seed and gin byproducts), and wheat 

(forage, grain, hay, and straw) grown from seed treated at the maximum rate are 

required pending the results from the requested metabolism studies.

• A wheat processing study conducted with triadimenol applied to wheat as a seed 

treatment should be submitted once the requested corn or wheat metabolism studies 

have been submitted and reviewed.

• Limited field rotational crop studies for triadimenol must be submitted pending the 

results from the requested metabolism studies. 

D. Labeling Changes Summary Table 

For triadimefon to be eligible for reregistration, all triadimefon labels must be 

amended to incorporate the risk mitigation measures outlined in Section IV. Table 34 

describes how language on the labels should be amended. 
67

Table 34. Labeling Changes Summary Table

Summary of Labeling Changes for Triadimefon 

Description Amended Labeling Language 

Manufacturing Use Products 

Only for formulation into a fungicide for the following use(s): golf course turfgrass, sodfarm turfgrass, 

outdoor- and greenhouse-grown ornamentals (trees, shrubs, flowering plants, including roses), azaleas 

(for control of pine-twisting rust only), pine trees (including Christmas trees), pine seedlings, pine seedand pineapple (preplant dip and postharvest dip only), “ “This product can not be formulated into end-use products with directions for use in residential or commercial settings on apples, grapes, pears, raspberries, azaleas (except to control pine-twisting rust only), or turfgrass (except for turfgrass on golf courses or sodfarms).” 

“This product can not be formulated into liquid concentrate end-use products with directions for use on azaleas, pine seedlings, pine seeds, or pineapple.” “This product can not be formulated into dry flowable end-use products with directions for use on pine trees, pine seedlings, or pineapple.” “This product can be formulated into granular end-use products with directions for use only on golf course turfgrass or sodfarm turfgrass.” 

One of these statements may be added to a label to allow reformulation of the product for a specific use or all additional uses supported by a formulator or user group 

“This product may be used to formulate products for specific use(s) not listed on the MP label if the formulator, user group, or grower has complied with U.S. EPA submission requirements regarding support of such use(s).” 

Environmental Hazards “Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other 

waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewatreatment plant authority. For guidance, contact your State Water Board or Regional Office of the EPA
68

End Use Products Intended for Occupational Use (WPS and NonWPS) 

PPE Requirements Established by the RED1 for 

liquid concentrate end-use products 

“Personal Protective Equipment (PPE)” “Some materials that are chemical-resistant to this product are (registrant inserts correct chemicalresistant material). If you want more options, follow the instructions for category [registrant inserts 

A,B,C,D,E,F,G,or H] Aon an EPA chemical-resistance category selection chart.” “Mixers, loaders, applicators, flaggers, and other handlers must wear: > Long sleeved shirt and long pants, > Shoes plus socks, and >Chemical resistant gloves, such as (registrant insert correct chemical-resistant materials) when 

mixing/loading or when applying using handheld equipment or handheld nozzles.” “See engineering controls for additional requirements.”

PPE Requirements Established by the RED1 for 

dry flowable end-use products Note: if the end-use product does not have directions for use as a seed treatment, then the phrase “or when handling treated seed (including spreading, drying, raking, bagging, and sewing seed bags)” may be dropped. 

“Personal Protective Equipment (PPE)” “Some materials that are chemical-resistant to this product are (registrant inserts correct chemicalresistant material). If you want more options, follow the instructions for category [registrant inserts 

A,B,C,D,E,F,G,or H] Aon an EPA chemical-resistance category selection chart.” “Mixers, loaders, applicators, flaggers, and other handlers must wear: > Long sleeved shirt and long pants, > Shoes plus socks, and >Chemical resistant gloves, such as (registrant insert correct chemical-resistant materials) when 

mixing/loading, when applying using handheld equipment or handheld nozzles, or when handling treateseed (including spreading, drying, raking, bagging, and sewing seed bags).” “See engineering controls for additional requirements.” 

PPE Requirements Established by the RED1 for 

wettable powder end-use products 

“Personal Protective Equipment (PPE)” “Some materials that are chemical-resistant to this product are (registrant inserts correct chemicalresistant material). If you want more options, follow the instructions for category [registrant inserts 

A,B,C,D,E,F,G,or H] Aon an EPA chemical-resistance category selection chart.” 
69

End Use Products Intended for Occupational Use (WPS and NonWPS) 

Note: all wettable powder 

products must be in water soluble packets to be eligible for reregistration. Note: if the end-use product does not have directions for use as a seed treatment, then the phrase “or when handling treated seed (including spreading, drying, raking, bagging, and sewing seed bags)” may be dropped. Note: if the end-use product does not have directions for use as a dip treatment, then the phrases “participating in dip applications” may be dropped. 

“Mixers, loaders, applicators, flaggers, and other handlers must wear: > Long sleeved shirt and long pants, > Shoes plus socks, > Chemical resistant gloves, such as (registrant insert correct chemical-resistant materials) when 

mixing/loading, when using handheld equipment or handheld nozzles, when participating in dip applications, or when handling treated seed (including spreading, drying, raking, bagging, and sewing seed bags), and > Chemical-resistant apron, when mixing/loading, when participating in dip applications, or cleaning spills or equipment.” “See engineering controls for additional requirements.” 

PPE Requirements Established by the RED1 for 

granular products 

“Personal Protective Equipment (PPE)” “Some materials that are chemical-resistant to this product are (registrant inserts correct chemicalresistant material). If you want more options, follow the instructions for category [registrant inserts 

A,B,C,D,E,F,G,or H] Aon an EPA chemical-resistance category selection chart.” “Loaders, applicators, flaggers, and other handlers must wear: > Long-sleeved shirt and long pants, > Shoes plus socks, and > Chemical resistant gloves, such as (registrant insert correct chemical-resistant materials) when loading.” “See engineering controls for additional requirements.” 
70

End Use Products Intended for Occupational Use (WPS and NonWPS) 

PPE Requirements Established by the RED1 for 

ready-to-use briquette products 

“Personal Protective Equipment (PPE)” “Some materials that are chemical-resistant to this product are (registrant inserts correct chemicalresistant material). If you want more options, follow the instructions for category [registrant inserts 

A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection chart.” “Applicators and other handlers must wear: > Long-sleeved shirt and long pants, > Shoes plus socks, and > Chemical resistant gloves, such as (registrant insert correct chemical-resistant materials). “ 

PPE Requirements Established by the RED1 for 

tree-injection products Note: if the tree-injection product is ready-to-use, the words “mixers, loaders” may be dropped 

“Personal Protective Equipment (PPE)” “Some materials that are chemical-resistant to this product are (registrant inserts correct chemicalresistant material). If you want more options, follow the instructions for category [registrant inserts 

A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection chart.” “Mixers, loaders, applicators and other handlers must wear: > Long-sleeved shirt and long pants, > Shoes plus socks, and > Chemical resistant gloves, such as (registrant insert correct chemical-resistant materials).” 

User Safety Requirements “Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washable

exist, use detergent and hot water. Keep and wash PPE separately from other laundry.” “Discard clothing and other absorbent materials that have been drenched or heavily contaminated with 

this product’s concentrate. Do not reuse them.” 
71

End Use Products Intended for Occupational Use (WPS and NonWPS) 

Engineering Controls for liquid, dry flowable , or granular formulations that contain directions for use for sodfarm turfgrass 

“Engineering Controls” “Pilots must use an enclosed cockpit in a manner that is consistent with the WPS for Agricultural Pesticides [40 CFR170.240(d)(6)]. Pilots must wear the PPE required on this labeling for applicators.” 

Engineering Controls for wettable powders packaged in water-soluble packets. All wettable powders must be in water soluble packets to be eligible for reregistration.

“Engineering Controls” “Water soluble packets when used correctly qualify as a closed mixing/loading system under the WorkeProtection Standard for Agricultural Pesticides [40 CFR 170.240(d)(4). Mixers and loaders using watesoluble packets must: -wear the personal protective equipment required on this labeling for mixers and loaders, and -be provided, have immediately available, and wear in an emergency, such as a broken package, spill, oequipment breakdown: >chemical resistant footwear and >a NIOSH-approved respirator equipped with: -- a dust/mist filter with MSHA/NIOSH approval number prefix TC-21C or 

-- any N, R, P, or HE filter.” “Pilots must use an enclosed cockpit in a manner that is consistent with the WPS for Agricultural Pesticides [40 CFR170.240(d)(6)]. Pilots must wear the PPE required on this labeling for applicators.” 

User Safety Recommendations 

“User Safety Recommendations” “Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.” “Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and puon clean clothing.” “Users should remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly and change into clean clothing.” 
72

End Use Products Intended for Occupational Use (WPS and NonWPS) 

Environmental Hazards “ ENVIRONMENTAL HAZARDS” 

“Do not apply directly to water, or to areas where surface water is present or to intertidal areas below th

mean water mark. Do not contaminate water when disposing of equipment washwater or rinsate.” “Do not apply when weather conditions favor drift from treated areas. Drift and runoff from treated are

may be hazardous to organisms in neighboring areas.” “This product may contaminate water through runoff. This product has a high potential for runoff for several months or more after application. Poorly draining soils and soils with shallow water tables are more prone to produce runoff that contains this product.” “This chemical has properties and characteristics associated with chemicals detected in ground water. T

use of this chemical in areas where soils are permeable, particularly where the water table is shallow, mresult in ground water contamination.” 

Restricted-Entry Interval (for labels with WPS uses) Note: the prohibition for sodfarms may be dropped if the end-use product does not contain directions for use on sodfarms 

“Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 12 

hours.” “Harvesting or transplanting turfgrass grown on sodfarms is prohibited for 17 days following application.” 

Early Reentry Personal Protective Equipment established by the RED (for labels with WPS uses) 

“PPE required for early entry to treated areas that is permitted under the Worker Protection Standard anthat involves contact with anything that has been treated, such as plants, soil, or water, is: > coveralls, > shoes plus socks, and > chemical-resistant gloves made of any waterproof material.” 

Entry Restriction for NonWPS uses 

Entry Restriction for non-WPS uses applied as a spray (does not include tree-injection uses):

“Do not enter or allow others to enter until sprays have dried.” 
73

End Use Products Intended for Occupational Use (WPS and NonWPS) 

Entry Restriction for non-WPS uses applied dry (does not include ready-to-use briquette uses):

“Do not enter or allow others to enter until dusts have settled.” Entry Restriction for non-WPS uses applied as a granular and when watering-in is required:“Do not enter or allow others to enter the treated area (except those involved in watering-in) until watering-in is complete and the surface is dry.” 

General Application Restrictions (for labels with WPS uses)

“Do not apply this product in a way that will contact workers or other persons, either directly or through drift. Only protected handlers may be in the area during application.” 

Other Application Restrictions (Risk Mitigation) 

All Products/Formulations Containing Triadimefon

Delete all directions for use for the following use-patterns: > apples > grapes > pears > raspberries > residential or commercial turfgrass (except for turfgrass on golf courses or sodfarms). Include the following statement: “Application to trees that bear fruit or nuts is prohibited. Applications are permitted on nonbearing fruit or nut trees only.” 

Spray Drift “Spray drift requirements”

(1) For groundbloom and aerial applications, use only medium or coarser spray nozzles according to ASABE (S572) definition for standard nozzles. Aerial applicators must consider flight speed and nozzlorientation in determining droplet size. 
74

End Use Products Intended for Occupational Use (WPS and NonWPS) 

(2) Make aerial or ground applications when the wind velocity is 3 to 10 mph. Do not apply when the wind speed is greater than 10 mph. For all non-aerial applications, wind speed must be measured adjaceto the application site on the upwind side, immediately prior to application. (4) Do not make aerial or ground applications into temperature inversions. (5) For groundboom applications, apply with nozzle height no more than 4 feet above the ground or crocanopy. (6) For airblast applications, turn off outward pointing nozzles at row ends and when spraying the outer two rows. To minimize spray loss over the top in tree applications, spray must be directed into the canopy. (7) For aerial applications, do not release spray at a height greater than 10 feet above the ground or plan

canopy. (8) For aerial applications, the outermost nozzles must not exceed 60% of the wingspan or 80% of the rotor blade diameter. (9) When aerial applications are made with a cross-wind, the swath will be displaced downwind. The 

applicator must compensate for this displacement at the downwind edge of the application area by 

adjusting the path of the aircraft upwind.” 

Application Restrictions for Turfgrass Uses (Note: The maximum allowable application rate per application or per year must be listed as pounds or gallons of formulated product per acre, not solely as pounds active ingredient per acre.) 

“Use on turfgrass is limited to sodfarm turf and golf course turf only. Use on turfgrass is prohibited on 

all other residential and commercial sites.” Maximum application rate is 2.7 lb ai/A Maximum annual application rate is 5.4 lb ai/A Minimum retreatment interval is 14 days. “Aerial application and chemigation to turf are permitted on sodfarm turfgrass only.” “Application to golf courses, including tees, greens, fairways, and roughs, is permitted only if the turfgrass is 2.5 inches or less in height.” 
75

End Use Products Intended for Occupational Use (WPS and NonWPS) 

“Harvesting or transplanting turfgrass grown on sodfarms is prohibited for 17 days following application.” 

Application Restrictions for Azaleas 

“Use on azaleas is limited to applications to control pine-twisting rust disease.” 

Application Restrictions for Ornamentals and Pine Trees, including Christmas trees 

“Chemigation is permitted for use on ornamentals and pine trees, including Christmas trees.” 

Application Restrictions for Ornamentals at Residential Sites Note: The maximum allowable application rate must be listed as pounds or gallons of formulated product per acre, not solely as pounds active ingredient per gallon.) 

“The maximum application rate for ornamentals (including azaleas) at residential sites is 0.0025 lb 

ai/gal.” 

End Use Products Intended Primarily for Use by Homeowners 

Environmental Hazards “ ENVIRONMENTAL HAZARDS” 

“Do not apply directly to water. Do not contaminate water when disposing of equipment washwaters or rinsate.” “Do not apply when weather conditions favor drift from treated areas. Drift and runoff from treated are

may be hazardous to organisms in neighboring areas.” “This product may contaminate water through runoff. This product has a high potential for runoff for 
76

End Use Products Intended for Occupational Use (WPS and NonWPS) 

several months or more after application. Poorly draining soils and soils with shallow water tables are more prone to produce runoff that contains this product.” “This chemical has properties and characteristics associated with chemicals detected in ground water. T

use of this chemical in areas where soils are permeable, particularly where the water table is shallow, mresult in ground water contamination.”

Application Restrictions All products:

“Do not apply this product in a way that will contact any person or pet, either directly or through drift. Keep people and pets out of the area during application.” 

Entry Restrictions Products Applied as a Liquid (except tree-injection uses): 

“Do not allow people or pets to enter the treated area until sprays have dried.” 

Directions for Use “Do not apply this product to lawns or other turfgrass.” Directions for Use on Ornamentals Note: The maximum allowable application rate must be listed as pounds or gallons of formulated product per acre, not solely as pounds active ingredient per gallon.) 

“Applications with hose-end sprayers are permitted only for outdoor use on ornamentals. Use of hoseend sprayer equipment in residential greenhouses is prohibited.” “The maximum application rate for ornamentals is 0.0025 lb ai/gal.” 

Other Application Restrictions (Risk Mitigation) 

All Products/Formulations Containing Triadimefon

Delete all directions for use for the following use-patterns: 
77

End Use Products Intended for Occupational Use (WPS and NonWPS) 

> apples > grapes > pears > raspberries > residential or commercial turfgrass Include the following statement: “Application to trees that bear fruit or nuts is prohibited. Applications are permitted on nonbearing fruit or nut trees only.” 

1 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this docu

protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7. 

2 The registrant must drop the N type filter from the respirator statement if the pesticide product contains or is used with oil. 

Instructions in the Labeling section appearing in quotations represent the exact language that should appear on the label. 

Instructions in the Labeling section not in quotes represents actions that the registrant should take to amend their labels or product registra
78

VI. Appendices
79

Appendix A: Use Patterns Subject to Reregistration for Triadimefon 

Site 

Application Type 

Application Timing 

Application Equipment 

Formulation Max. Single Application Rate 

(ai) 

Max. # 

Apps. 

Minimum 

Retreatment 

Interval (Days) 

Us

(Food Uses) Pineapples (post-harvest or pre-plant crowns) 

Pre-plant and Post-harvest dip, spray 

WP 0.0028 lbs ai/gallon 1 Not Required; 

since only one 

application. 

(NR) 

All wettable powder prsoluble bags. 

(Non-food Uses) Azaleas (for control of pine twisting rust, only 

Chemigation, groundboom, lowpressure handwand, high pressure handwand 

WP 

DF 

0.005 lbs ai/gallon 8 14 All wettable powder pr

soluble bags. 

Christmas trees

Aerial, flagging, airblast WP 0.25 lbs ai/A 8 14 A closed cockpit is requ

formulations). All wettable powder prsoluble bags. 

Golf Course Turf
80

Site 

Application Type 

Application Timing 

Application Equipment 

Formulation Max. Single Application Rate 

(ai) 

Max. # 

Apps. 

Minimum 

Retreatment 

Interval (Days) 

Us

Groundboom, LCO handgun, lowpressure handwand, and handgun sprayer Flagging, tractor-drawn spreader 

LC 

WP 

DF 

G 

2.7 lbs ai/A 

2 

(at max. 

single app. 

rate) 

14 

Use is restricted to golf A maximum annual appallowed. Applications are restricheight. This applies to tees, greens, fairways, aAll wettable powder prsoluble bags. 

Greenhouse Ornamentals (including flowers, shrubs, and trees) 

Low-pressure handwand, handgun sprayer, high-pressure handwand 

WP 

LC 

0.00625 lbs ai/gallon 0.00938 lbs ai/gallon 

8 

14 14 

Prohibit residential (conapplications in greenhoAll wettable powder prsoluble bags. 

Ornamentals (including flowers, shrubs and trees) 

Low-pressure handwand, handgun sprayer, high-pressure handwand Low-pressure handwand, chemigation, groundboom, highpressure handwand 

LC 

WP 

DF 

0.0023 lbs ai/gallon 0.0025 lbs ai/gallon 

8 

14 14 

Residential (consumer) 

Professional hose-end sAll wettable powder prsoluble bags. 

Ornamentals (including shade trees and woody shrubs) 
81

Site 

Application Type 

Application Timing 

Application Equipment 

Formulation Max. Single Application Rate 

(ai) 

Max. # 

Apps. 

Minimum 

Retreatment 

Interval (Days) 

Us

Tree injection unit (ready-to-use micro injection unit, or unit requiring product dilution) 

LC 0.000026 lbs ai/ inch of 

trunk circumference 

6 NS 

Pines (including Christmas trees) 

Low-pressure handwand and handgun sprayer 

LC 0.0023 lbs ai/gallon 8 14 

Pine Seed (on-nursery applications) 

Dip Planter box, hopper box, cement mixer, Cement mixer 

WP WP 

DF 

0.0000625 lbs ai/gallon 

0.0013 lbs ai/A 

0.00136 lbs ai/A 

1 1 1 

NR NR NR 

All wettable powder prsoluble bags. 

Pine Seed (commercial applications) 

Commercial loading/applying, commercial bagging of treated seed, commercial bag sewing, and multiple commercial activities 

WP 0.0013 lbs ai/lb 1 NR All wettable powder pr

soluble bags. 

Pine Seedlings

Aerial, flagging, airblast, groundboom, low-pressure handwand, handgun sprayer By hand 

WP 

Ready-to-use 

briquette 

0.5 lbs ai/A 

0.000019 lbs ai/seedling 

4 1 

NR NR 

A closed cockpit is requAll wettable powder prsoluble bags. 

Roses
82

Site 

Application Type 

Application Timing 

Application Equipment 

Formulation Max. Single Application Rate 

(ai) 

Max. # 

Apps. 

Minimum 

Retreatment 

Interval (Days) 

Us

Low-pressure handwand, handgun sprayer, high-pressure handwand 

LC 

WP 

0.00029 lbs ai/gallon 8 14 All wettable powder pr

soluble bags. 

Sod Farm Turf

Aerial, chemigation, flagging, groundboom, LCO handgun, lowpressure handwand, and handgun sprayer Aerial, flagging, tractor-drawn spreader 

WP 

DF 

G 

2.7 lbs ai/A 

2 

(at max. 

single app. 

rate) 

17 

A closed cockpit is requformulations). A maximum annual appallowed. All wettable powder prsoluble bags. 
83

Appendix B. Table of Generic Data Requirements and Studies Used to Make the 

Reregistration Decision

 

GUIDE TO APPENDIX B

 Appendix B contains listing of data requirements which support the reregistration for 

active ingredients within the case 2700 covered by this RED/TRED. It contains generic data 

requirements that apply to triadimefon/triadimenol in all products, including data 

requirements for which a "typical formulation" is the test substance. 

 The data table is organized in the following formats: 

 1. Data Requirement (Column 1). The data requirements are listed in the order 

in which they appear in 40 CFR part 158. The reference numbers 

accompanying each test refer to the test protocols set in the Pesticide 

Assessment Guidance, which are available from the National technical 

Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 

487-4650. 

 2. Use Pattern (Column 2). This column indicates the use patterns for which the 

data requirements apply. The following letter designations are used for the 

given use patterns. 

 A. Terrestrial food 

 B. Terrestrial feed 

 C. Terrestrial non-food 

 D. Aquatic food 

 E. Aquatic non-food outdoor 

 F. Aquatic non-food industrial 

 G. Aquatic non-food residential 

 H. Greenhouse food 

 I. Greenhouse non-food 

 J. Forestry 

 K. Residential 

 L. Indoor food 

 M. Indoor non-food 

 N. Indoor medical 

 O. Indoor residential 

 3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its 

files, this column list the identify number of each study. This normally is the 

Master Record Identification (MIRD) number, but may be a "GS" number if 

no MRID number has been assigned. Refer to the Bibliography appendix for 

a complete citation of the study. 
84

APPENDIX B-1

Data Supporting Guideline Requirements for the Reregistration of Triadimefon

REQUIREMENT USE 

PATTERN

CITATION(S)

 PRODUCT CHEMISTRY

New 

Guideline 

Number

Old 

Guideline 

Number

 

830.1550 61-1 Product Identity and Composition All CSF (’96) 

830.1600 61-2A Start. Mat. & Mnfg. Process All 00098119, 42307801 

830.1620 61-2B Description of Production Process All 00098119, 42307801 

830.1650 61-2B Description of Formulation Process All 00098119, 42307801 

830.1670 61-2B Formation of Impurities All 40477401 

830.1700 62-1 Preliminary Analysis All 00098120, 44166001 

830.1750 62-2 Certification of limits All 44166001, CSF (’96) 

830.1800 62-3 Enforcement Analytical Method All 42307802 

830.6302 63-2 Color All 41616001 

830.6303 63-3 Physical State All 41616001 

830.6304 63-4 Odor All 41616001 

830.6313 63-13 Stability to Normal and Elevated 

Temperatures, Metals and Metal Ions 

All 42307803 

830.6314 63-14 Oxidation/Reduction: Chemical 

Incompatibility 

All Not Applicable; N/A 

830.6315 63-15 Flammability All N/A 

830.6316 63-16 Explodability All N/A 

830.6317 63-17 Storage Stability All N/A 

830.6319 63-19 Miscibility All N/A 

830.6320 63-20 Corrosion Characteristics All N/A 

830.7000 63-12 pH All 41616001 

830.7050 None UV/Visable Absorption All N/A 

830.7100 63-18 Viscosity All 41616001 
85

Data Supporting Guideline Requirements for the Reregistration of Triadimefon

REQUIREMENT USE 

PATTERN

CITATION(S)

830.7200 63-5 Melting Point All 41616001 

830.7220 63-6 Boiling Point All N/A 

830.7300 63-7 Relative Density All 41616001 

830.7370 63-10 Dissociation Constants in Water All N/A 

830.7550 

830.7560 

or 

830.7570 

63-11 Octanol/Water Partition Coefficient All 42307803 

830.7840 

or 

830.7860 

63-8 Water solubility: column elution 

method; shake flask method 

All 41616001 

830.7950 63-9 Vapor Pressure All 42307801 

ECOLOGICAL EFFECTS

850.2100 71-1 Avian Acute Oral Toxicity 00071469, 41895901 

850.2200 71-2A Avian Dietary Toxicity - Quail 00071469, 00050066 

850.2200 71-2B Avian Dietary Toxicity - Duck 00126277 

850.2300 71-4 Avian Reproduction –Avian chronic 

tests on the Mallard Duck and 

Bobwhite Quail 

 00110430, 00110431, 

40283102, 42342301 

850.2400 71-3 Mammal Acute/ Chronic Toxicity- Rat 00125411, 00151248, 

00155075, 00264276, 

92188019, 92188320 

850.1010 72-2A Invertebrate Toxicity 00071469, 00231311, 

254693, 41922101 

850.1025 72-3B Estuarine/Marine Toxicity - Mollusk Data Gap 

850.1035 

850.1045 

72-3C Estuarine/Marine Toxicity – Shrimp 

EC50 

Data Gap 

850.1075 72-3A Estuarine/Marine Fish LC50 Data Gap 

850.1075 72-1A Fish Toxicity- Bluegill 00071469, 43304301 

850.1075 72-1C Fish Toxicity- Rainbow Trout 00071469, 43256201 

850.1300 72-4A Freshwater Fish- Early Life Stage 00251243, 41922103 
86

Data Supporting Guideline Requirements for the Reregistration of Triadimefon

REQUIREMENT USE 

PATTERN

CITATION(S)

850.1500 72-5 Life Cycle Fish N/A 

850.1735 None Freshwater Acute InvertebrateToxicity 00071469, 00231311, 

00246736, 41922102 

850.4100 122-1A Terrestrial Toxicity; Seedling 

Emergence 

 N/A 

850.4150 122-1B Terrestrial Plant Toxicity; Vegetative 

Vigor 

 N/A 

850.5400 122-2 Aquatic Plant Growth 00159558, 00266051 

850.4225 123-1A Seed Germination and Seedling 

Emergence (Tier 2) 

Data Gap 

850.4250 123-1B Vegetative Vigor (Tier 2) Data Gap 

850.4400 123-2 Aquatic Vascular Plant Growth (Tier2) Data Gap 

850.3020 141-1 Honey Bee Acute Contact 05001991, 42307804 

850.3030 141-2 Honey Bee Residue on Foliage N/A 

 TOXICOLOGY 

870.1100 81-1 Acute Oral Toxicity 00125411, 00264276, 

43936101 

870.1200 81-2 Acute Dermal Toxicity-Rat 00145086, 00264276 

870.1300 81-3 Acute Inhalation Toxicity-Rat 41616002 

870.2400 81-4 Primary Eye Irritation-Rabbit 41782501 

870.2500 81-5 Primary Skin Irritation- Rabbit 41616004 

870.2600 81-6 Dermal Sensitization- Guinea pig 41554001 

870.6100 82-5A 90-Day Neurotoxicity- Hen 44153501 

870.6300 83-6 Developmental Neurotoxicity Study 00089023; Data Gap 

870.3100 82-1A 90-Day Feeding - Rat 00048624 

870.3100 82-1A 30-Day Oral Toxicity- Rat 00048627 

870.3150 82-1B 90-Day Feeding (Non-rodent)- Dog 00048625, 00060226 

870.3200 82-2 21-Day Dermal Toxicity- Rat 42341501 

870.3700 83-3A Developmental Toxicity - Rat 00089023, 00149336, 

92188018 
87

Data Supporting Guideline Requirements for the Reregistration of Triadimefon

REQUIREMENT USE 

PATTERN

CITATION(S)

870.3700 83-3B Developmental Toxicity - Rabbit 41446201, 42089601 

870.3800 83-4 2-Generation Reproduction - Rat 00155075, 92188019, 

92188020 

The reproductive study in 

the rat is acceptable/ nonguideline in conjunction 

with the 3-generation study 

(MRID 00032541) 

870.3800 83-4 Reproduction and fertility effects (3-

Gen)- Rat 

 00032541 

The reproductive study in 

the rat is acceptable/ nonguideline in conjunction 

with the multi-generation 

reproduction study (MRID 

00155075) 

870.4100 83-1B Chronic Toxicity - Dog 00032539, 00126261 

870.4200 83-2B Carcinogenicity- Mice 40752101, 40865101 

870.4300 83-5 2-year Combined 

Chronic/Oncogenicty- Rat 

 42153901 

870.5100 84-2 Mutagenicity-Gene Mutation- bacterial 00126264, 00099413 

870.5395 84-2 Micronuleus Assay 00048637 

870.5450 84-2 Cytogenetics Dominant Lethal Assay 00048628 

870.5550 84-2 Unscheduled DNA Synthesis Assay 00159343 

870.6200 81-8 Acute Neurotoxicity Screening BatteryRat  43495509, 43936101 

870.6200 82-7 Subchronic Neurotoxicity Screening 

Battery- Rat 

 44153501 

870.7485 85-1 General Metabolism- Rat 00033057, 42409101 

OCCUPATIONAL/RESIDENTIAL EXPOSURE 

875.2400 133-3 Dermal Passive Dosimetry Exposure 43125401 

875.2500 133-4 Inhalation Passive Dosimetry Exposure 43125401 

None 231 Estimation of Dermal Exposure at 

Outdoor Sites 45654503 
88

Data Supporting Guideline Requirements for the Reregistration of Triadimefon

REQUIREMENT USE 

PATTERN

CITATION(S)

None 232 Estimation of Inhalation Exposure at 

Outdoor Sites 45654503

ENVIRONMENTAL FATE 

None 160-5 Chemical Identity N/A 

835.2120 161-1 Hydrolysis 41922101 

835.2240 161-2 Photodegradation - Water 42112901 

835.2410 161-3 Photodegradation - Soil 00044169, 42820401 

835.2370 161-4 Photodegradation - Air N/A 

835.4100 162-1 Aerobic Soil Metabolism 42242701, 42224104, 

41686102, 

835.4200 162-2 Anaerobic Soil Metabolism 41686101, 42401201 

835.4400 162-3 Anaerobic Aquatic Metabolism 41686101, 42401201 

835.4300 162-4 Aerobic Aquatic Metabolism 42224104 

835.1240 163-1 Leaching/Adsorption/Desorption 41616008, 42356601 

835.1410 163-2 Laboratory Volatilization N/A 

835.8100 163-3 Volatility- Field N/A 

835.6100 164-1 Terrestrial Field Dissipation 42242701, 41686103, 

41686104 

835.6200 164-2 Aquatic Field Dissipation N/A 

835.6300 164-3 Forestry Dissipation N/A 

860.1950 165-4 Bioaccumulation in Fish 41619901 

None 165-5 Bioaccumulation- Aquatic Nontarget 41619901 

835-7100 166-1 Ground Water- Small Scale 

Prospective 

 N/A 

840.1100 201-1 Spray Droplet Size Spectrum N/A 

840.1000 201-4 Background for Pesticide Aerial Drift 

(Evaluation) 

 N/A 

840.1200 202-1 Spray Drift Field Deposition 

(Evaluation) 

 N/A 

RESIDUE CHEMISTRY 
89

Data Supporting Guideline Requirements for the Reregistration of Triadimefon

REQUIREMENT USE 

PATTERN

CITATION(S)

860.1200 171-3 Directions for Use N/A 

860.1300 171-4A Nature of Residue - Plants 42123401, 42123402, 

42123403, 42798901, 

42853401, 92188025-33 

860.1300 171-4B Nature of Residue - Livestock 42123404, 42856801, 

42864901, 43418301-02, 

92188034-39 

860.1340 171-4C Residue Analytical Method - Plants 43870101, 44041002, 

92188040-43 

860.1340 171-4D Residue Analytical Method - 

Livestock 

 43418303, 92188044-48 

860.1360 171-4M Multiresidue Methods 41976601, 43705401 

860.1380 171-4E Storage Stability Data- Plant and 

Livestock 

 41976602, 42857401, 

44038901, 44041001, 

92188051-53, 43462401 

860.1480 171-4J Magnitude of Residues -

Meat/Milk/Poultry /Egg 

 92188054-57 

860.1500 171-4K Crop Field Trials 92188060-65, 92188070, 

92188073-75, 42342303-08, 

41809401 

860.1520 171-4L Magnitude of Residue in Processed 

Food/Feed 

 42346601, 43948601, 

92188064-65, 92188069, 

43284401, 42013201, 

92188074 

860.1850 165-1 Confined Accumulation in Rotational 

Crops Study 

 42613301 

860.1900 165-2 Field Accumulation in Rotational 

Crops Study 

 N/A 
90

APPENDIX B-2

Data Supporting Guideline Requirements for the Reregistration of Triadimenol

REQUIREMENT USE 

PATTERN

CITATION(S)

 PRODUCT CHEMISTRY

New 

Guideline 

Number

Old 

Guideline 

Number

 

830.1550 61-1 Product Identity and Composition All N/A 

830.1600 61-2A Start. Mat. & Mnfg. Process All N/A 

830.1620 61-2B Description of Production Process All N/A

830.1650 61-2B Description of Formulation Process All N/A

830.1670 61-2B Formation of Impurities All N/A

830.1700 62-1 Preliminary Analysis All N/A

830.1750 62-2 Certification of limits All N/A

830.1800 62-3 Enforcement Analytical Method All N/A

830.6302 63-2 Color All N/A

830.6303 63-3 Physical State All N/A

830.6304 63-4 Odor All N/A

830.6313 63-13 Stability to Normal and Elevated 

Temperatures, Metals and Metal Ions 

All Data Gap 

830.6314 63-14 Oxidation/Reduction: Chemical 

Incompatibility 

All N/A 

830.6315 63-15 Flammability All N/A 

830.6316 63-16 Explodability All N/A 

830.6317 63-17 Storage Stability All N/A 

830.6319 63-19 Miscibility All N/A 

830.6320 63-20 Corrosion Characteristics All N/A 

830.7000 63-12 pH All Not available; Data Gap 

830.7050 None UV/Visable Absorption All Not Available; Data Gap 

830.7100 63-18 Viscosity All N/A 
91

Data Supporting Guideline Requirements for the Reregistration of Triadimenol

REQUIREMENT USE 

PATTERN

CITATION(S)

830.7200 63-5 Melting Point All 00125399 

830.7220 63-6 Boiling Point All N/A 

830.7300 63-7 Relative Density All 00125399 

830.7370 63-10 Dissociation Constants in Water All Not available 

830.7550 

830.7560 

or 

830.7570 

63-11 Octanol/Water Partition Coefficient All Not available; Data Gap 

830.7840 

or 

830.7860 

63-8 Water solubility: column elution 

method; shake flask method 

All 00125399; Data Gap 

830.7950 63-9 Vapor Pressure All 00125399 

 TOXICOLOGY 

870.1100 81-1 Acute Oral Toxicity 00125411 

870.1200 81-2 Acute Dermal Toxicity-Rat 00145086 

870.1300 81-3 Acute Inhalation Toxicity-Rat 00145087 

870.2400 81-4 Primary Eye Irritation-Rabbit 00145088 

870.2500 81-5 Primary Skin Irritation- Rabbit 00145088 

870.2600 81-6 Dermal Sensitization- Guinea pig 00125413 

870.3100 82-1A 90-Day Oral Toxicity- Rat 00127769, 42192701 

870.3150 82-1B 90-Day Oral Toxicity (Non-rodent )- 

Dog 

 00125420 

870.3150 82-1B 6 months oral toxicity (Non-rodent)- 

Dog 

 00151247 

870.3200 82-2 15-Day Dermal Toxicity- Rabbit 00151246 

870.3465 82-4 21-Day Inhalation Toxicity- Rat 00125421 

870.3700 83-3A Prenatal Developmental Toxicity - Rat 40307804, 40887702, 

41498401 

870.3700 83-3B Developmental Toxicity - Rabbit 40307805, 40887703, 

42365001 
92

Data Supporting Guideline Requirements for the Reregistration of Triadimenol

REQUIREMENT USE 

PATTERN

CITATION(S)

870.3800 83-4 2-Gen. reproduction and fertility effects 

- Rat 

 00151248 

870.4100 83-1B Chronic Toxicity - Dog 00150484, 00159012 

870.4200 83-2B Carcinogenicity- Mice 00126259, 44740901 

870.4300 83-5 Combined Chronic/CarcinogenicityRat  00126260 

870.5100 84-2 Bacterial system, mammalian 

activation-Gene Mutation 

 00126264 

870.5300 84-2 In Vitro Mammalian Cell Gene 

Mutation 

 00126269 

870.5450 84-2 Cytogenetics Dominant Lethal Assay 00126266 

870.5500 84-2 Other Genotoxicity DNA Damage 00126271 

870.5550 84-2 Other Genotoxicity Unscheduled DNA 

Synthesis 

 00126271 

870.5900 84-2 Other Effects In Vitro Sister Chromatid 

Exchange Assay 

 40815901 

870.6100 81-7 Acute Neurotoxicity Study Data Gap 

870.6200 82-7 Subchronic Neurotoxicity Study Data Gap 

Other none Other Studies; Central Nervous EffectsMice  00145083 

RESIDUE CHEMISTRY 

860.1200 171-3 Directions for Use N/A 

860.1300 171-4A Nature of Residue - Plants 42123401-03, 42798901, 

42853401, 92188025-33 

860.1300 171-4B Nature of Residue - Livestock 42123404, 42856801, 

42864901, 43418301-02, 

92188034-39 

860.1340 171-4C Residue Analytical Method - Plants 43870101, 44041002, 

92188040-43 

860.1340 171-4D Residue Analytical Method - 

Livestock 

 43418303, 92188044-48 

860.1360 171-4M Multiresidue Methods 40969801, 41976601, 

43705401 
93

Data Supporting Guideline Requirements for the Reregistration of Triadimenol

REQUIREMENT USE 

PATTERN

CITATION(S)

860.1380 171-4E Storage Stability Data- Plant and 

Livestock 

 41976602, 42857401, 

44038901, 44041001, 

92188051-53, 43462401 

860.1480 171-4J Magnitude of Residues -

Meat/Milk/Poultry /Egg 

 92188054-57 

860.1500 171-4K Crop Field Trials 00125407-09, 40615201, 

41051401, 41242801, 

42696308-09, 42712101 

860.1520 171-4L Magnitude of Residue in Processed 

Food/Feed 

 44519801-03 

860.1850 165-1 Confined Accumulation in Rotational 

Crops Study 

 42613301 

860.1900 165-2 Field Accumulation in Rotational 

Crops Study 

 N/A 
94

Appendix C. Technical Support Documents 

 Additional documentation in support of this RED is maintained in the OPP docket, 

located in Room 119, Crystal Mall #2, 1801 South Bell Street, Arlington, VA. It is open 

Monday through Friday, excluding Federal Holidays, from 8:30 am to 4 pm. 

 The docket contains the risk assessments and related documents as of August 30, 

2006. The availability announcement will be published in the Federal Register. All 

documents, in hard copy form, may be viewed in the OPP docket room or downloaded or 

viewed via the internet at the following site: www.epa.gov/pesticides/reregistration. The 

following list details all documents related to the Triadimefon/Triadimenol (RED/TRED). 

Health Effects Documents: 

1. DP Barcode 329823 and D328572. Jin Kim, Tara Chandgoyal and Jonathan 

Becker. July 18, 2006. Characterization of Triadimefon Use on Golf Courses, 

Turf, Pine Seed and Seedling Treatment, and Pineapple. 

2. DP Barcode D314778. Yvonne Barnes and Sheila Piper. July 6, 2006. 

Triadimefon: Revised Acute, Probabilistic and Chronic Dietary (Food + 

Drinking Water) Exposure and Risk Assessments for the Triadimefon 

Reregistration. 

3. DP Barcode D331455. Yvonne Barnes and Sheila Piper. August 1, 2006. 

Triadimefon + Triadimenol: Aggregate Acute, Chronic, and Short-Term Risk 

Assessments Reflecting July, 2006 Risk Mitigation in Response to the Phase 4 

Triadimefon RED. 

5. DP Barcode D328262. Rich Griffin. June 20, 2006. Triadimefon: HED 

Response to Comments Received During the Public Comment Phase. 

6. DP Barcode D330611. Rich Griffin. July 10, 2006. 

Triadimefon/Triadimenol: Summary of Refinements and Revisions to the 

Human Health Risk Assessment. 

7. DP Barcode D314814 and D315040. Shanna Recore. June 30, 2006. 

Triadimefon: Occupational and Residential Exposure Assessment for the 

Reregistration Eligibility Decision Document. 

8. Meeting Summary. Kimberly Nesci. EPA/FDA Joint Teleconfernce on July 

11, 2006 to Discuss 1,2,4 Triazole (Free Triazole) as a Common Metabolite of 

Triazole Derivative Fungicides and Anastrozole, a Drug. 

9. Sam Ary. Triadimefon. Acute and Chronic Dietary Exposure Assessments for 

the Reregistration Eligibility Decision (RED) Document. 
95

10. DP Barcode D321636. Sam Ary. August 31, 2005. Triadimefon. Registrants 

Response to Residue Chemistry Data Requirements. Magnitude of 

Triadimefon Residues of Concern in Apple Processed Commodities. 

11. DP Barcode D314778. Sam Ary. November 23, 2005. Triadimefon. Acute 

and Chronic Dietary Exposure Assessments for the Reregistration Eligibility 

Decision (RED) Document. 

12. DP Barcode D315115. Yvonne Barnes. November 22, 2005. Triadimefon: 

 Summary of Product Chemistry Data for Reregistration Eligibility Decision 

 (RED) Document. 

13. DP Barcode D 326678. Rich Griffin. February 9, 2006. Triadimefon. 

 Preliminary Human Health Risk Assessment (Revised). 

14. DP Barcode D314742. Sam Ary. November 23, 2005. Triadimefon. 

Summary of Analytical Chemistry and Residue Data for the Reregistration 

Eligibility Decision (RED) Document. 

15. DP Barcode D314928. Sam Ary. November 18, 2005. Triadimenol Acute 

 and Chronic Dietary Exposure Assessments for the Tolerance Reassessment 

 Eligibility Decision Document. 

16. DP Barcode D314891. Sam Ary. November 17, 2005. Triadimenol. 

 Summary of Analytical Chemistry and Residue Data for the Tolerance 

 Reassessment Eligibility Decision Document. 

17. DP Barcode D326716. Christina Jarvis. January 24, 2006. Triadimenol HED 

Chapter of the Tolerance Reassessment Eligibility Decision Document 

(Revised). 

18. DP Barcode D322336. Sam Ary. October 14, 2005. Triadimenol. 

Registrants Response to Residue Chemistry Data Requirements. 

19. DP Barcode D315152. Yvonne Barnes. November 22, 2005. Summary of 

Product Chemistry Data for Tolerance Reassessment Document. 

20. DP Barcode D322240. Jack Arthur. December 9, 2005. Occupational and 

Residential Exposure/Risk Assessment of 1,2,4-Triazole. 

21. DP Barcode D 322238. Michael Doherty. November 1, 2005. 1,2,4-Triazole. 

Acute and Chronic Dietary Exposure Assessments to Support Reregistration 

and Registration Actions for Triazole-derivative Fungicides. 
96

22. DP Barcode D322239. Michael Doherty. December 20, 2005. Triazole 

Alanine and Triazole Acetic Acid. Acute and Chronic Dietary Exposure 

Assessments to Support Reregistration and Registration Actions for Triazolederivative Fungicides. 

23. DP Barcode D322215. Michael Doherty. February 7, 2006. 1,2,4-Triazole, 

Triazole Alanine, triazole Acetic Acid: Human Health Aggregate Risk 

Assessment in Support of Reregistration and Registration Actions for 

Triazole-derivative Fungicide Compounds. 

24. Kathleen Raffaele. Triazoles- 2nd Report of the Ad Hoc HED Peer Review 

Committee. 

Ecological Fate and Effects Documents: 

1. DP Barcode D328531. Fred Jenkins and Jonathan Angier. June 1, 2006. 

Response to Bayer Public Comments Regarding the Environmental Fate and 

Effects Division Triadimefon Risk Assessment. 

2. DP Barcode D 331725. Fred Jenkins and Jonathan Angier. August 3, 2006. 

EFED Revisions to the Ecological Risk Assessment (dated Aug. 30, 2005) 

and the Drinking Water Exposure Assessment (dated Aug. 31, 2005) in 

Support of the Triadimefon Reregistration Eligibility Decision Document. 

3. DP Barcode D316941. Jonathan Angier. August 31, 2005. Tier 2 Drinking 

 Water Assessment for Triadimefon and its Major Degradate Triadimenol. 

4. Jonathan Angier and Michelle Embry. January 19, 2006. Environmental Fate 

 and Ecological Risk Assessment for Triadimefon. 

5. DP Barcode D312519. James Breithaupt. February 9, 2005. TRED for 

 Triadimenol; Drinking Water Assessment. 

 6. DP Barcode D329271. James Hetrick. June 15, 2006. Response to Triazole 

 Task Force Comments on the FQPA Drinking Water Assessment for 1,2,4-

 Triazole (1,2,4-T), Triazole alanine (TA), and Triazole acetic acid (TAA). 

 

Other Documents: 

 1. Memorandum. John A. Lazor. EPA 1,2,4 Triazole Consult Response. 
97

Appendix D. Citations Considered to be Part of the Data Base Supporting the 

Reregistration Eligibility Decision (Bibliography) for Triadimefon and Triadimenol 

Bibliography 

MRID Citation Reference 

32539 Hoffman, K.; Groning, P. (1978) Meb 6447 Long-Term Toxicity Study on Dogs (Two-Year 

Feeding Study): Report No. 7882; Report No. 66656. (Unpublished study received Apr 28, 

1980 under 3125- 318; prepared by Bayer, AG, submitted by Mobay Chemical Corp., 

Kansas City, Mo.; CDL:099413-D) 

32541 Loser, E.; Lorke, D. (1979) Meb 6447 Multigeneration Reproduction Study on Rats: Report 

No. 8297; Report No. 67752. (Unpublished study received Apr 28, 1980 under 3125-318; 

prepared by Bayer, AG, submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL: 

099413-F) 

33057 Fredrickson, D.R. (1978) Metabolism of Bayleton^(TM)I in Rats: Re- port No. 66201. 

(Unpublished study received Apr 28, 1980 under 3125-318; submitted by Mobay Chemical 

Corp., Kansas City, Mo.; CDL:099415-F) 

48624 Mohr, U. (1976) Meb 6447: Subchronic Toxicity Study on Rats (Twelve -Week Feeding 

Experiment): Report No. R 840 a; Report No. 44300. (Unpublished study received Aug 15, 

1977 under 3125-318; pre- pared by Medizinische Hochschule Hannover, Abteilung fur 

Experi- mentelle Pathologie, West Germany, submitted by Mobay Chemical Corp., Kansas 

City, Mo.; CDL:231312-C) 

48625 Hoffman, K.; Luckhaus, G. (1974) Meb 6447: Subchronic Toxicity Study on Dogs 

(Thirteen-Week Feeding Experiment): Report No. 5071; Report No. 44737. (Unpublished 

study received Aug 15, 1977 under 3125-318; prepared by Bayer, AG, submitted by Mobay 

Chemical Corp., Kansas City, Mo.; CDL:231312-D) 

48627 Thyssen, J.; Kimmerle, G.; Luckhaus, G. (1974) Meb 6447: Subacute Toxicity Studies: 

Report No. 4464; Report No. 46338. (Unpub- lished study received Aug 15, 1977 under 

3125-318; prepared by Bayer, AG, submitted by Mobay Chemical Corp.; Kansas City, Mo.; 

CDL:231312-F) 

48628 Machemer, L. (1976) Meb 6447: Dominant Lethal Study on Male Mice to Test for 

Mutagenic Effects: Report No. 5837; Report No. 47929. (Unpublished study received Aug 

15, 1977 under 3125-318; pre- pared by Bayer, AG, submitted by Mobay Chemical Corp., 

Kansas City, Mo.; CDL:231312-G) 

48637 Machemer, L. (1977) MEB 6447 (Triadimefon, Bayleton Active Ingre- dient): Micronucleus 

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52724. (Unpublished study received Aug 15, 1977 under 3125-318; prepared by Bayer, AG, 

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50066 Fink, R.; Beavers, J.B. (1977) Final Report: Eight-Day Dietary LC50--Bobwhite Quail: 

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3125-318; pre- pared by Wildlife International, Ltd., submitted by Mobay Chemi- cal Corp., 

Kansas City, Mo.; CDL:231311-K) 
98

MRID Citation Reference 

60226 Hoffmann, K.; Luckhaus, G.; Lorke, D. (1974) Meb 6447: Subchronic Toxicity Study on 

Dogs (Thirteen-Week Feeding Experiment): Re- port No.5071; Report No. 44737. 

(Unpublished study received Dec 15, 1977 under 3125-EX-149; prepared by Bayer, AG, W. 

Germany, submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL: 232490-D) 

71469 Mobay Chemical Corporation Agricultural Chemicals Division; Environmental Toxicology 

of Baytan (Triadimenol); KWG 0519; October 29, 1982. 

89023 Nagumo, K.; Teraki, Y.; Chiba, T.; et al. (1981) Teratogenicity Test of MEB 6447 in 

Pregnant Rats: ?Submitter| 80257. (Unpub- lished study received Jan 5, 1982 under 1F2474; 

prepared by St. Marianna Univ., First Dept. of Anatomy, Laboratory of Embry- ology, 

submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL: 070570-A) 

98119 Smith, D.N. (1981) Bayleton Manufacture. (Unpublished study re- ceived Mar 30, 1982 

under 2F2665; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:070747-A) 

98120 Harbin, D.N.; Slahck, S.C.; Westphal, C. (1982) The Composition of Technical 

^(R)IBayleton: Report No. 80605. (Unpublished study received Mar 30, 1982 under 2F2665; 

submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:070747-B) 

110430 Mobay Chemical Corp. (1982) Synopsis of Environmental Toxicology of Bayleton. 

Summary of studies 248117-B through 248117-E. (Unpublished study received Aug 17, 

1982 under 3125-318; CDL: 248117-A) 

110431 Lamb, D.; Carsel, M.; Mallicoat, D.; et al. (1982) Triadimefon (Bayleton) Reproduction 

Study with Bobwhite Quail: Study No. 81- 675-03; 80753. (Unpublished study received Aug 

17, 1982 under 3125-318; submitted by Mobay Chemical Corp., Kansas City, MO; 

CDL:248117-B) 

125399 Mobay Chemical Corp. (1983) Product Chemistry of Baytan. (Compi- lation; unpublished 

study received Mar 11, 1983 under 3125-346; CDL:071461-A) 

125411 Mihail, F.; Thyssen, J.; Lorke, D. (1980) KWG 0519 (Triadimenol): Acute Toxicity Studies-

-(Isomer Ratio 80:20): Bayer Report No. 9451; 69378. (Unpublished study received Mar 11, 

1983 under 3125-346; prepared by Farbenfabriken Bayer, AG, W. Ger., submitted by Mobay 

Chemical Corp., Kansas City, MO; CDL: 071466-B) 

125421 Kimmerle, G.; Lorke, D. (1976) KWG 0519: Subacute Inhalation Toxicity Study on Rats: 

Report No. 6321; 51130. (Unpublished study received Mar 11, 1983 under 3125-346; 

prepared by Farben- fabriken Bayer, AG, W. Ger., submitted by Mobay Chemical Corp., 

Kansas City, MO; CDL:071466-M) 

126259 Bomhard, E.; Loser, E.; Frank; et al. (1982) KWG 0519 (Triadimenol, Baytan Active 

Ingredient): Chronic Toxicological Study on Mice (Feeding Experiment over Two Years): 

Report No. 10855- 82291. (Unpublished study received Mar 11, 1983 under 3125- 346; 

prepared by Farbenfabriken Bayer, AG, W. Ger., submitted by Mobay Chemical Corp., 

Kansas City, MO; CDL:071467-A) 

126260 Kroetlinger, F.; Loeser, E.; Schilde, B.; et al. (1982) KWG 0519: (Triadimenol, the Active 

Ingredient of Baytan): Chronic Toxicity Study on Rats (2-year Feeding Experiment): Bayer 

Report No. 11009; 82358. (Unpublished study received Mar 11, 1983 under 3125-346; 
99

MRID Citation Reference 

prepared by Bayer AG, W. Ger., submitted by Mobay Chemical Corp., Kansas City, MO; 

CDL:071468-A) 

126261 Hoffmann, K.; Groning, P.; Lorke, D. (1978) MEB 6447: Long-term Toxicity Study on 

Dogs (Two-year Feeding Study): Report No. 7882; 66656. (Unpublished study received Mar 

11, 1983 under 3125-346; prepared by Bayer AG, W. Ger., submitted by Mobay Chemical 

Corp., Kansas City, MO; CDL:071468-B) 

126264 Herbold, B.; Lorke, D. (1979) KWG 0519: Salmonella/Microsome Test for Detection of 

Point-mutagenic Effects: Report No. 8189; 67595. (Unpublished study received Mar 11, 

1983 under 3125-346; prepared by Bayer AG, W. Ger., submitted by Mobay Chemical 

Corp., Kansas City, MO; CDL:071468-F) 

126266 Herbold, B.; Lorke, D. (1978) KWG 0519: Dominant Lethal Study on Male Mouse to Test 

for Mutagenic Effects: Report No. 7900; 66746. (Unpublished study received Mar 11, 1983 

under 3125-346; prepared by Bayer AG, W. Ger., submitted by Mobay Chemical Corp., 

Kansas City, MO; CDL:071468-H) 

126269 Cifone, M.; Balinas, V. (1982) Mutagenicity Evaluation of KWG 0519 in the Mouse 

Lymphoma Forward-mutation Assay: LBI Safety No. 7607; 82353. Final rept. (Unpublished 

study received Mar 11, 1983 under 3125-346; prepared by Litton Bionetics, Inc., submitted 

by Mobay Chemical Corp., Kansas City, MO; CDL: 071468-K) 

126271 Herbold, B.; Lorke, D. (1981) KWG 0519: Triadimenol, the Active Ingredient of Baytan: 

Study of DNA Damage Using the E. coli Pol Al- Test: Bayer Report No. 10265; 80212. 

(Unpublished study received Mar 11, 1983 under 3125-346; prepared by Bayer AG, W. 

Ger., submitted by Mobay Chemical Corp., Kansas City, MO; CDL:071468-M) 

126277 Lamb, D.; Toll, P.; Mallicoat, D.; et al. (1981) Acute Dietary LC50 of Technical 

Triadimenol (Baytan) to Mallard Ducks and Bobwhite Quail: Study No. 80-175-09 and 80-

175-05. (Unpublished study received Mar 11, 1983 under 3125-346; submitted by Mobay 

Chemical Corp., Kansas City, MO; CDL:071469-F) 

145083 Polacek, I. (1983) Central Nervous Effects of KWG 0519 (Pilot Study): Study No. 03018. 

Unpublished study prepared by Toxicol- ogical Institute Regensburg. 17 p. 

145086 Hixson, E. (1983) Acute Dermal Toxicity of Baytan 25% Dry Flowable in Rabbits: Study 

Number 83-023-05. Unpublished study prepared by Mobay Chemical Corporation. 11 p. 

145087 Sangha, G. (1983) Acute Inhalation Toxicity Study with Baytan 25% Dry Flowable in Rats: 

Study Number 83-041-08. Unpublished study prepared by Mobay Chemical Corporation. 16 

p. 

145088 Hixson, E. (1984) Eye and Dermal Irritation of Baytan 25% Dry Flowable in Rabbits: Study 

Numbers 83-323-06 and 83-333-06. Unpublished study prepared by Mobay Chemical 

Corporation. 16 p. 

149331 Mihail, F. (1980) MEB 6447: Acute Toxicity Studies: Report No. 9277. Unpublished study 

prepared by Bayer AG. 10 p. 
100

MRID Citation Reference 

149336 Unger, T.; Van Goethem, D.; Shellenberger, T. (1982) A Terato- logical Evaluation of 

Bayleton in Mated Female Rats: MRI Project No. 7272-B. Unpublished study prepared by 

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 150484 Hoffmann, K.; Vogel, O. (1984) KWG 0519 (C.N. Triadimenol) First Chronic Study of 

Toxicity to Dogs on Oral Administration (Two- year Feeding Study): KWG 0519/005. 

Unpublished study prepared by Bayer AG. 254 p. 

151246 Heimann, K.; Schilde, B. (1984) KWG 0519 (Suggested Common Name: Triadimenol, the 

Active Ingredient of BAYTAN): Subacute Dermal Toxicity Study on Rabbits: Bayer Report 

No.: 12496. Unpublished study prepared by Bayer AG. 66 p. 

151247 Hoffmann, K. (1984) KWG 0519 (c.n. Triadimenol): Second Chronic Study of Toxicity to 

Dogs on Oral Administration (Six-month Feeding Study): Report No.: 12971. Unpublished 

study prepared by Bayer AG. 127 p. 

151248 Loeser, E.; Eiben, R. (1984) KWG 0519 (Proposed c.n. Triadimenol): Generation Study on 

Rats: Report No.: 12390. Unpublished study prepared by Bayer AG. 250 p. 

155075 Eiben, R. (1984) MEB 6447 (Triadimefon): Two-generation Study with Rats: 

Supplementary Study: Report No. 12712. Unpublished study prepared by Bayer AG, 

Institute of Toxicology. 168 p. 

159012 Hoffmann, K. (1984) Investigation of the Body Weight Development of Beagle Dogs in 

Chronic Toxicity Studies (Survey, 1973-1983): Pharma Report No. 12385. Unpublished 

study prepared by Bayer Pharmaceuticals Div. 14 p. 

159343 Herbold, B. (1985) MEB 6447 C.N. Triadimefon: Pol Test on E. coli To Evaluate for 

Potential DNA Damage: Revised Report: Report No. 12780. Unpublished translation, 

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159558 Heimbach, F. (1985) Growth Inhibition of Green Algae (Scenedesmus subspicatus) by 

Triadimefon (Technical): Test Report: Report HBF/A112: Study No. A105/85. Unpublished 

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231311 Chemagro Agricultural Division, Bayleton Fish and Wildlife Safety, June, 18 1977. 

246736 Mobay Chemical Corporation, Corporate Toxicology Department, Stanley 

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667-01 Author: D. W. Lang. 

251243 Mobay Chemical Corporation, Toxicity of Triadimefon (Bayleton) To Rainbow Trout Early 

Life Stages; Report No. 85939 September 9, 1983. 

254693 Mobay Chemical Corporation, Bayleton Fish and Wildlife Data, Brochure, confidential 

document number AS 84-2461; September, 1984. 

264276 Mobay Corporation Environmental Health Research;Toxicology of Bayleton; 

Supplement No. 5 to Original Brochure Date June 6, 1977; Brochure No. 1441; February 21, 

1986. 

266051 Bayer AG, 1986, Influence of KWG 0519 on the Growth of Green Algae in Nutrient 

Solution, Report No. 82684 
101

MRID Citation Reference 

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40283102 Mobay Corporation Coroporate Toxicology Department; Effect of 

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40615201 Pither, K. (1988) Triadimenol--Magnitude of Residues on Bananas: Baytan Objective No. 

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40752101 Bomhard, E. (1986) MEB 6447: Carcinogenicity Study on NMRI Mice (21-Month 

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1190 p. 

40819101 Nagata, T. (1981) Triadimefon Subacute Toxicity on Rats: 3-Month Feeding Study: Report 

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40865101 Bombard, E.; Hahnemann, S. (1986) MEB 6447: Common Name: Triadime- fon, the Active 

Ingredient of Bayleton: Carcinogenicity Study on NMRI Mice: Project ID 87287. 

Unpublished study prepared by Bayer Ag. 5 p. 

40887702 Becker, H. (1987) Embryotoxicity (Including Teratogenicity) Study with KWG 0519 in the 

Rat: Project ID 94463. Unpublished study prepared by Research and Consulting Co. 13 p. 

40887703 Becker, H. (1987) Embryotoxicity (Including Teratogenicity) Study with KWG 0519 in the 

Rabbit: Project ID 94762. Unpublished stu- dy prepared by Research and Consulting Co. 

AG. 9 p. 

40969801 Foushee, G. (1988) Baytan, Multiresidue Method Trial: Project ID; 87-4705; Mobay Report 

No. 95672. Unpublished study prepared by Langston Laboratory, Inc. 526 p. 

41051401 Pither, K. (1989) Triadimenol--Magnitude of Residues on Bananas: Baytan Objective No. 

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41242801 Rockwell, J. (1988) Residues of Baytan and Its Metabolites in Cotton: Morse Laboratories 

45659, 45661. Unpublished study pre- pared by Morse Laboratories. 354 p. 

41446201 Clemens, G.; Hartnagel, R. (1990) Teratology Study in the Rabbit with MEB 6447 

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102

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41498401 Clemens, G.; Troup, C.; Hartnagel, R. (1990) Developmental Toxicity Study in the Rat with 

Baytan Technical: Report No.: MTD0156. Unpublished study prepared by Miles, Inc., 

Toxicology Depart- ment. 263 p. 

41554001 Sheets, L. (1990) Dermal Sensitization Study with Technical Grade Triadimefon (Bayleton) 

in Guinea Pigs: Lab Project Number: 90-324-EL. Unpublished study prepared by Mobay 

Corp. 21 p. 

41616001 Talbot, T. (1990) Product Chemistry of Bayleton Technical: Supple- ment 1: Lab Project 

Number: 80298; 85997; 91321. Unpublished study prepared by Mobay Corp. 25 p. 

41616002 Warren, D. (1990) Acute Four-Hour Inhalation Toxicity Study with Bayleton Technical in 

Rats: Lab Project Number: 90-042-GL. Un- published study prepared by Mobay Corp. 31 p. 

41616004 Sheets, L. (1990) Primary Dermal Irritation Study with Technical Grade Triadimefon 

(Bayleton) in Rabbits: Lab Project Number: 90-325-EK. Unpublished study prepared by 

Mobay Corp. 16 p. 

41616008 Daly, D. (1987) Soil Adsorption/Desorption with ?carbon 14|- Bayleton: Final Report: Lab 

Project Number: 36354. Unpublished study prepared by Analytical Bio-Chemistry 

Laboratories, Inc. 50 p. 

41619901 Grau, R. (1990) Triadimefon: Bioconcentration in Fish: Lab Project Number: E2880381/0. 

Unpublished study prepared by Mobay Corp. 55 p. 

41686101 Leimkuehler, W.; Lenz, C. (1989) The Anaerobic Soil Metabolism of ?Triazole-3,5 carbon 

14| Triadimefon 1: Lab Project Number: BL0- 42102. Unpublished study prepared by 

Mobay Corp. 33 p. 

41686102 Leimkuehler, W.; Lenz, C.; Stevenson, T. et al. (1989) The Aerobic Metabolism of 

?Triazole-3,5, carbon 14| Triadimenfon1: Lab Pro- ject Number: BL042101. Unpublished 

study prepared by Mobay Corp. 42 p. 

41686103 Carey, R. (1990) Subsurface Soil Investigation Report: Lab Project Number: ML022101. 

Unpublished study prepared by Mobay Corp. 44 p. 

41686104 Carey, R. (1990) Subsurface Soil Investigation Report: Lab Project Number: ML022101. 

Unpublished study prepared by Mobay Corp. 72 p. 

41782501 Sheets, L. (1990) Primary Eye Irritation Study with Bayleton 50% WP in Rabbits: Lab 

Project Number: 90-335-GY. Unpublished study prepared by Mobay Corporation 18 p. 

41809401 Williams, B. (1991) Triadimefon: Magnitude of the Residue Crop Field Trials: Lab Project 

Number: 38613-1: BL19GR01: 100122. Unpublished study prepared by Analytical BioChemistry Laborato- ries Inc. 323 p. 

41895901 Stafford, T. (1991) Technical Bayleton: An Acute Oral LD50 with Bobwhite Quail (Colinus 

virginianus): Lab Project Number: BL711- 701: 101222. Unpublished study prepared by 

Mobay Corp. 21 p. 
103

MRID Citation Reference 

41922101 Cain, K.; Moore, K. (1991) Stability of Triadimefon in Sterile Aqueous Buffer Solutions: 

Lab Project Number: BL072401: 101291. Unpublished study prepared by Mobay Corp. 26 

p. 

41922102 Gagliano, G. (1991) Chronic Toxicity of Bayleton Technical to the Waterflea (Daphnia 

magna) Under Static Renewal Conditions: Lab Project Number: BL840701: 101298. 

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41922103 Cohle, P.; Friesen, K. (1991) Early Life-Stage Toxicity of Bayleton to Fathead Minnows 

(Pimephal-es promelas) in a Flow-through Sys- tems: Lab Project Number: 39006: 101301. 

Unpublished study pre- pared by ABC Laboratories, Inc. 75 p. 

41976601 Ver Hey, M. (1991) Bayleton, KWG 1323 and KWG 1342: Multiresidue Method Testing: 

Lab Project Number: MOBAY/1093: BL161601. Un- published study prepared by Colorado 

Analytical Research & Dev., Corp. 380 p. 

41976602 Williams, B.; Conrath, B. (1991) Triadimefon/Triadimenol Freezer Storage Stability Study 

in Wheat Gain, Grapes, and Tomatoes: Amended Report: Lab Project Number: 36987-1: 

BL142301: 100105. Unpublished study prepared by Analytical Bio-Chemistry Laboratories. 417 p. 

42013201 Pither, K. (1991) Triademefon (500DF): Magnitude of the Residue on Pineapple Processed 

Products: Lab Project Number: BL19PN02B: 101325. Unpublished study prepared by ABC 

Labs, Inc. and Maui Pineapple Company, Ltd. 324 p. 

42089601 Clemens, G.; Hartnagel, R. (1991) Teratology Study in the Rabbit with MEB 6447: 

Supplement to MRID 41446201: Lab Project Number: 100026: MTD0149. Unpublished 

study prepared by Miles, Inc., Tox. Dept. 11 p. 

42112901 Krolski, M.; Bosnak, L. (1991) Addendum I: Additional Characteriza- tion of the 

Degradation Products Found in the Triadimefon Aqueous Photolysis Study: Lab Project 

Number: 101357: BL082402. Unpublished study prepared by Mobay Corp. 25 p. 

42123401 Krolski, M. (1991) Addendum I: Raw Data on the Fate of ?carbon 14| Triadimefon on 

Tomatoes and Cucumbers: Lab Project Number: 68593 -1. Unpublished study prepared by 

Stoner Labs, Inc. 20 p. 

42123402 Minor, R. (1991) Addendum I: Raw Data for the Metabolism of Triadim efon in Apples: Lab 

Project Number: 53621-1. Unpublished study prepared by Mobay Corp. 19 p. 

42123403 Duah, F. (1991) Addendum I: Raw Data on The Metabolism of Bayleton on Grapes: Lab 

Project Number: 88790-1. Unpublished study pre- pared by Mobay Corp. 27 p. 

42123404 Chopade, H. (1991) Addendum I: Raw Data for the Metabolism of Triad imefon in Male and 

Female Pigs: Lab Project Number: 66509-1. 51 p. 

42153901 Bomhard, E.; Schilde, B. (1991) MEB 6447: Chronic Toxicity and Cancerogenicity Studies 

on Wistar Rats with Administration in Diet over a Period of 105 Weeks: Lab Project 

Number: 20774: 101922. Unpublished study prepared by Bayer Ag., Dept. of Toxicology. 

1029 p. 
104

MRID Citation Reference 

42192701 Nishimura, N. (1983) Subacute Toxicity Study of KWG 0519 in Dietary Administration to 

Rats for 13 Weeks: Lab Project Num- ber: 101939. Unpublished study prepared by Bozo 

Research Cent- er Inc. 320 p. 

42224104 Leikmuehler, W.; Lenz, C.; Stevenson, T.; et al. (1989) The Aerobic Metabolism of 

(Triazole-3,5-carbon 14) Triadimenfon (sic): Lab Project Number: BLO42101: 99773. 

Unpublished study prepared by Mobay Corp. 45 p. 

42242701 Grace, T.; Cain, K. (1991) Dissipation of Triadimefon in California Soils: Revised: Lab 

Project Number: 100150: BL830089R0A: 892010.1-1K. Unpublished study prepared by 

Plant Science, Inc., Siemer and Associates, Inc., and Ricerca, Inc. 4388 p. 

42307801 Fontaine, L. (1992) Supplemental Product Chemistry of Bayleton Technical: Lab Project 

Number: MCL0054. Unpublished study prepared by Miles, Inc. 22 p. 

42307802 Fontaine, L. (1992) Supplemental Product Chemistry of Bayleton Technical: Lab Project 

Number: ANR-00692: ANR-00792. Unpublished study prepared by Miles, Inc. 20 p. 

42307803 Fontaine, L. (1992) Supplemental Product Chemistry of Bayleton Technical: Lab Project 

Number: 52834: 68665: 85997. Unpublished study prepared by Miles, Inc. 41 p. 

42307804 Hoxter, K.; Lynn, S. (1992) Technical Bayleton: An Acute Contact Toxicity Study with the 

Honey Bee (LD50): Lab Project Number: 149-168B: BL761401: 102633. Unpublished study 

prepared by Wildlife Intl., Inc. 18 p. 

42341501 Sheets, L.; Phillips, S.; Lake, S. (1992) A Repeated Dose 21-Day Dermal Toxicity Study 

with Technical Grade Triadimefon (Bayleton) in Rats: Lab Project Number: 91-122-LE; 

102680. Unpublished study prepared by Miles, Inc. 215 p. 

42342301 Stafford, T. (1992) Technical Bayleton: A One Generation Reproduction Study with 

Bobwhite Quail: Lab Project Number: BL741701. Unpublished study prepared by Miles, 

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42342303 Burger, R. (1992) Triadimefon (50DF)--Magnitude of the Residue on Apples: Lab Project 

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42342304 Burger, R. (1992) Triadimefon (50DF)--Magnitude of the Residue on Cantaloupe: Lab 

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42342305 Burger, R. (1992) Triadimefon (50DF)--Magnitude of the Residue on Cucumber: Lab 

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42342306 Burger, R. (1992) Triadimefon (50DF)--Magnitude of the Residue on Pears: Lab Project 

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42342307 Burger, R. (1992) Triadimefon (50DF)--Magnitude of the Residue on Pineapple: Lab Project 

Number: BL 19PN02: 39256: 102649. Unpublished study prepared by Miles, Inc., ABC 

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105

MRID Citation Reference 

42342308 Burger, R. (1992) Triadimefon (50DF)--Magnitude of the Residue on Summer Squash: Lab 

Project Number: BL 19SQ01: 39589: 102629. Unpublished study prepared by Miles, Inc. 

and ABC Laboratories. 420 p. 

42346601 Burger, R. (1992) Triadimefon (50DF)-Magnitude of the Residue on Processed Apple 

Commodities: Lab Project Number: BL-19AP02: 39591: 102636. Unpublished study 

prepared by Miles Inc. and ABC Laboratories. 233 p. 

42356601 Cain, K.; Green, D. (1992) Leaching of Aged Residues of Triadimefon: Lab Project 

Number: BL092101: 102631. Unpublished study prepared by Miles Inc. 33 p. 

42365001 Clemens, G.; Grosso, D.; Anderson, E.; et al. (1992) A Developmental Toxicity Study in 

Rabbits with Baytan Technical: Lab Project Number: MTD0256: 102692. Unpublished 

study prepared by Miles, Inc. 159 p. 

42401201 Schmidt, J.; Head, L. (1992) Anaerobic Aquatic Metabolism of ?carbon-14| Triadimefon: 

Lab Project Number: BLO42401: 103207: 392331. Unpublished study prepared by ABC 

Labs, Inc. 60 p. 

42409101 Chopade, H. (1992) Disposition and Metabolism of ?Phenyl-UL-carbon 14| Triadimefon in 

Rats: Lab Project Number: BLO41801: 102640. Unpublished study prepared by Miles, Inc. 

251 p. 

42613301 Mattern, G.; Parker, G.; Wendt, S. (1992) Confined Accumulation of (Phenyl-UL-(carbon 

14)) Triadimefon Residues in Rotational Crops: Lab Project Number: BL051601: 91.027: 

P309W: 103806. Unpublished study prepared by Miles Inc., Plant Sciences, Inc. and PTRL 

West, Inc. 152 p. 

42696308 Williams, B. (1992) Triadimenol--Magnitude of the Residue on Barley, 2.6F ST: Amended 

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42696309 Williams, B. (1992) Triadimenol--Magnitude of the Residue on Oats, 2.6F ST: Amended 

Final Report: Lab Project Number: 388151: BT19OA01: 100352. Unpublished study 

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42712101 Williams, B. (1992) Triadimenol--Magnitude of the Residue on Wheat, 2.6F ST. 

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42798901 Krolski, M. (1993) Fate of Bayleton-(carbon 14) as a 25 Percent Wettable Powder on 

Tomatoes and Cucumbers. Mass Spectral Data on (carbon 14) Triadimefon Residues. 

42853401 Chopade, H. (1993) Metabolism of (Phenyl-UL-(carbon 14)) Triadimefon in Wheat: Lab 

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42856801 Hall, L.; Hartz, A. (1993) The Metabolism of (carbon 14) Triadimefon in the Lactating Goat: 

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42857401 Williams, B.; Chickering, C. (1993) Triadimefon and Metabolites--Freezer Storage Stability 

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MRID Citation Reference 

42864901 Duah, F.; Smasal, T. (1993) Metabolism of Triadimefon in Laying Hens: Lab Project 

Number: BL040501: 105183. Unpublished study prepared by Miles Inc. 129 p. 

43125401 Eberhart, D.; Ellisor, G. (1993) Evaluation of Potential Exposure Resulting from Contact 

with Bayleton-Treated Turf: Lab Project Number: 92E043: 105137. Unpublished study 

prepared by Miles, Inc. 432 p. 

43256201 Bowers, L. (1994) Acute Toxicity of Bayleton Technical to the Rainbow Trout 

(Oncorhynchus mykiss) Under Static Renewal Conditions: Lab Project Number: BL812201: 

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43284401 Burger, R. (1994) Triadimefon (50DF): Magnitude of the Residue in Processed Grape 

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prepared by Miles Inc. in cooperation with ABC Laboratories, Inc. and The National Food 

Laboratory, Inc. 648 p. 

43304301 Bowers, L.; Frank, J. (1994) Acute Toxicity of BAYLETON Technical to the Bluegill 

(Lepomis macrochirus) under Static-Renewal Conditions: Lab Project Number: BL810301: 

106758. Unpublished study prepared by Miles Environmental Research Section. 27 p. 

43418301 Hall, L.; Hartz, A. (1994) The Metabolism of (carbon 14) Triadimefon in the Lactating Goat: 

Addendum 1: Additional Data as Requested by the EPA: Lab Project Number: BL041001: 

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43418302 Duah, F.; Myers, T. (1994) Metabolism of Triadimefon in Laying Hens: Addendum 1: 

Additional Data as Requested by EPA: Lab Project Number: BL040501: 105183-1. 

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43418303 Duah, F.; Myers, T.; Freeseman, P. (1994) Extraction Efficiency of the Analytical Method 

for Triadimefon Residues in Meat, Milk, and Eggs: Lab Project Numbers: BL200201: 

106449. Unpublished study prepared by Miles, Inc. 44 p. 

43462401 Duah, F. (1994) Storage Stability of Triadimefon Residues in Animal Tissues, Milk, and 

Eggs: Lab Project Number: BL130201: 106638. Unpublished study prepared by Miles Inc. 

37 p. 

43495509 Beyrouty, P. (1992) An Acute Study of the Potential Effects of Orally Administered 

Triadimefon on Behavior in Rats: Lab Project Number: 97132. Unpublished study prepared 

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43705401 Fomenko, J. (1995) Evaluation of KWG 1732 (a Tridimefon Metabolite) Through the FDA 

Multiresidue Methods: Lab Project Numbers: K2162301: 106963: A012.009. Unpublished 

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43870101 Bajzik, M. (1995) Independent Laboratory Validation of the Analytical Residue Method for 

Triadimefon and Metabolites in Plant Matrices (Report No. 106549): Lab Project Number: 

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43936101 Dreist, M.; Popp, A. (1996) MEB 6447 (Common Name: Triadimefon): Acute Oral 

Neurotoxicity Screening Study in Wistar Rats: Lab Project Number: 24636: 1058215: 

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43948601 Murphy, J. (1996) Triadimefon (50DF)--Magnitude of the Residue on Processed Apple 

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44038901 Lenz, C. (1996) Triadimefon and Metabolites--Freezer Storage Stability Study in Raw 

Agricultural Commodities and Processed Commodities: Addendum 2: Lab Project Number: 

BL131601: 102641-2: 39683. Unpublished study prepared by ABC Laboratories, Inc. 586 p. 

44041001 Chopade, H. (1996) Metabolism of (Phenyl-UL-(carbon 14)) Triadimefon in Wheat: 

Addendum 1--Storage Stability of (carbon 14) KWG 1732 in Wheat Grain: Lab Project 

Number: BL221601: 105162-1. Unpublished study prepared by Bayer Corp. 30 p. 

44041002 Chopade, H. (1996) Extraction Efficiency of the Analytical Residue Method for the 

Determination of Triadimefon and Metabolite Residues in Plant Matrices: Determination of 

Aged (carbon 14) Triadimefon Residues in Wheat Grain: Lab Project Number: BL221601: 

107343. Unpublished study prepared by Bayer Corp. 35 p. 

44153501 Dreist, M.; Popp, A. (1996) MEB 6447 (Common Name: Triadimefon): Subchronic 

Neurotoxicity Screening Study in Wistar Rats: (Thirteen-Week Administration in the Diet 

with a Four-Week Recovery Period in Males and a Ten-Week Recovery Period in Females): 

Lab Project Number: 25315: T 6058265: 107477. Unpublished study prepared by Bayer AG. 

786 p. 

44166001 Fontaine, L. (1996) Product Chemistry of Bayleton Technical: Lab Project Number: 107296: 

107241: 99642. Unpublished study prepared by Bayer Corp. 173 p. 

44519801 Shen, S. (1998) Determination of Residues of Baytan 30 in Processed Field Corn Fractions: 

Lab Project Number: 96-003: 963HI: 43514. Unpublished study prepared by ABC Labs., 

Inc. and Gustafson Research and Development Center. 458 p. {OPPTS 860.1520} 

44519802 Shen, S. (1998) Determination of Residues of Baytan 30 in Processed Cotton Fractions: Lab 

Project Number: 96-001: 963HG: 43516. Unpublished study prepared by ABC Labs., Inc. 

and Gustafson Research and Development Center. 452 p. {OPPTS 860.1520} 

44519803 Shen, S. (1998) Determination of Residues of Baytan 30 in Processed Wheat Fractions: Lab 

Project Number: 96-002: 963HH: 43513. Unpublished study prepared by ABC Labs., Inc. 

and Gustafson Research and Development Center. 462 p. {OPPTS 860.1520} 

44740901 Schaldt, L. (1998) KWG 0519 Oncogenicity Study in CD-1 Mice (Dietary Administration 

over 18 Months): Lab Project Number: 28299: T4060738: 108689. Unpublished study 

prepared by Bayer AG. 1854 p. 

45654503 Findlay, M.; Chester, G. (1995) Seed Treated Products: Worker Exposure During Sowing of 

Treated Seed with "Baytan": Lab Project Number: N(DEGREES)WER002. Unpublished 

study prepared by ZENECA Agrochemicals. 107 p. 

46576207 Mithcell, H. (2005) Product Chemistry of Bayleton FLO Fungicide. Project Number: 

BR/2392, ANR/06605, 3414519/1. Unpublished study prepared by Bayer Corp. 134 p. 

46578707 Mitchell, H. (2005) Product Chemistry of Tartan Flo Fungicide. Project Number: BR/2390, 

ANR/04605, ANR/04705. Unpublished study prepared by Bayer Corp. 205 p. 
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MRID Citation Reference 

46836301 Mitchell, H. (2006) Product Chemistry of Bayleton 3.62% SC Systemic Fungicide. Project 

Number: BR/2462, 201435, ANR/03006. Unpublished study prepared by Bayer Corp. 180 p. 

92188018 Eigenberg, D. (1990) Mobay Corporation Phase 3 Summary of MRID 00149336. A 

Teratological Evaluation of Bayleton (Triadimefon) in Mated Female Rats: Project 7272-B 

(Mobay Report 82270). Prepared by MIDWEST RESEARCH INSTITUTE. 22 p. 

92188019 Eigenberg, D. (1990) Mobay Corporation Phase 3 Summary of MRID 00155075 and 

Related MRIDs 00032541. MEB 6447 (Triadimefon) Multigeneration Reproduction Study 

on Rats; (Triadimefon) Two-generation Study with Rats (Bayleton): Projects 8297 and 

12712 (Mobay Reports 67752 and 82270). Prepared by BAYER AG. 38 p. 

92188020 Loser, E. (1990) Mobay Corporation Phase 3 Reformat of MRID 00032541 and Related 

MRIDs 00155075. MEB 6447 (Triadimefon) Multigeneration Reproduction Study on Rats: 

Project Number 67752; Report No. 8297. Prepared by BAYER AG. 173 p. 

92188025 Chopade, H. (1990) Mobay Corporation Phase 3 Summary of MRID 00025540. The 

Metabolism of BAYLETON in Apples: Project Report No. 53621. Prepared by MOBAY 

CORPORATION. 14 p. 

92188026 Mango, R.; Puhl, R.; Thornton, J. (1990) Mobay Corporation Phase 3 Reformat of MRID 

00025540. The Metabolism of BAYLETON in Apples: Project No. 53621. Prepared by 

MOBAY CORPORATION. 26 p. 

92188027 Chopade, H. (1990) Mobay Corporation Phase 3 Summary of MRID 00031440 and Related 

MRIDs 00031441. Fate of BAYLETON-Carbon-14 as a 25% Wettable Powder on Tomatoes 

and Cucumbers: Project Report Nos. 68593 and 68594. Prepared by MOBAY 

CORPORATION. 13 p. 

92188028 Nye, D. (1990) Mobay Corporation Phase 3 Reformat of MRID 00031440. Fate of 

BAYLETON-Carbon-14 as a 25 Percent Wettable Powder on Tomatoes and Cucumbers: 

Project Report 68593. Prepared by STONER LABORATORIES, INC. 33 p. 

92188029 Puhl, R. (1990) Mobay Corporation Phase 3 Reformat of MRID 00031441. Further 

Identification of Polar Activity from BAYLETON Cucumber and Tomato Metabolism 

Samples: Project Report No. 68594. Prepared by MOBAY CORPORATION. 10 p. 

92188030 Chopade, H. (1990) Mobay Corporation Phase 3 Summary of MRID 00098115. Metabolism 

of BAYLETON in Wheat: Project Report No. 80293. Prepared by MOBAY 

CORPORATION. 14 p. 

92188031 Morgan, J.; Lenz, M. (1990) Mobay Corporation Phase 3 Reformat of MRID 00098115. 

Metabolism of BAYLETON in Wheat: Project Report No. 80293. Prepared by MOBAY 

CORPORATION. 29 p. 

92188032 Chopade, H. (1990) Mobay Corporation Phase 3 Summary of MRID 00150893. Metabolism 

of BAYLETON on Grapes: Project Report No. 88790. Prepared by MOBAY 

CORPORATION. 12 p. 

92188033 Fredrickson, R. (1990) Mobay Corporation Phase 3 Reformat of MRID 00150893. 

Metabolism of BAYLETON on Grapes: Project Report No. 88790. Prepared by MOBAY 

CORPORATION. 21 p. 
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MRID Citation Reference 

92188034 Chopade, H. (1990) Mobay Corporation Phase 3 Summary of MRID 00025543. Metabolism 

of BAYLETON in the Cow: Project Report No. 66202. Prepared by MOBAY 

CORPORATION. 11 p. 

92188035 Fredrickson, D. (1990) Mobay Corporation Phase 3 Reformat of MRID 00025543. 

Metabolism of BAYLETON in the Cow: Project Report No. 66202. Prepared by MOBAY 

CORPORATION. 19 p. 

92188036 Premkumar, N. (1990) Mobay Corporation Phase 3 Summary of MRID 00033058. 

Metabolism of BAYLETON in Male and Female Pigs: Project No. 66509. Prepared by 

MOBAY CORPORATION. 16 p. 

92188037 Pither, K. (1990) Mobay Corporation Phase 3 Reformat of MRID 00033058. Metabolism of 

BAYLETON in Male and Female Pigs: Project Report No. 66509. Prepared by MOBAY 

CORPORATION. 25 p. 

92188038 Mathew, A. (1990) Mobay Corporation Phase 3 Summary of MRID 00033070. The Fate of 

BAYLETON-Carbon-14 in Poultry: Project Report No. 67482. Prepared by MOBAY 

CORPORATION. 16 p. 

92188039 Nye, D. (1990) Mobay Corporation Phase 3 Reformat of MRID 00033070. The Fate of 

BAYLETON-Carbon-14 in Poultry: Project Report No. 67482. Prepared by STONER 

LABORATORIES, INC. 67 p. 

92188040 Obrist, J.; Nichols, S.; Leimkuehler, W. (1990) Mobay Corporation Phase 3 Reformat of 

MRID 00025546. An Interference Study for the BAYLETON and KWG 0519 Residue 

Method for Crops: Project Report No. 68006. Prepared by MOBAY CORPORATION. 208 

p. 

92188041 Leimkuehler, W. (1990) Mobay Corporation Phase 3 Reformat of MRID 00125782. An 

Interference Study for BAYLETON Residue Method for Crops - Resolution of Interference 

for KWG 1342 and KWG 1323: Project Report No. 80567. Prepared by MOBAY 

CORPORATION. 225 p. 

92188042 Chopade, H. (1990) Mobay Corporation Phase 3 Summary of MRID 00149163 and Related 

MRIDs 00025546, 00125782. Residue Analysis Procedure for BAYLETON and Metabolites 

in Plants: Project Report Nos. 80488, 68006 and 80567. Prepared by MOBAY 

CORPORATION. 16 p. 

92188043 Obrist, J.; Leimkuehler, W. (1990) Mobay Corporation Phase 3 Reformat of MRID 

00149163. Residue Analysis Procedure for BAYLETON and Metabolites in Barley and 

Wheat: Project Report No. 80488. Prepared by MOBAY CORPORATION. 28 p. 

92188044 Minor, R. (1990) Mobay Corporation Phase 3 Summary of MRID 00090019 and Related 

MRIDs 00090020, 00063837, 00072538, 00149342, 00063835. Analytical Methods for 

BAYLETON in Various Animal Tissues: Project Report Nos. 69531, 80265, 68705, 68798, 

69028 and 68887. Prepared by ANALYTICAL DEVELOPMENT CORP. 21 p. 

92188045 Kruplak, J. (1990) Mobay Corporation Phase 3 Reformat of MRID 00090019. BAYLETON 

Total Residue Method Verification (Bovine): Project Report No. 69531. Prepared by 

ANALYTICAL DEVELOPMENT CORP. 158 p. 
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MRID Citation Reference 

92188046 Obrist, J.; Nichols, S. (1990) Mobay Corporation Phase 3 Reformat of MRID 00063835. An 

Interference Study for the BAYLETON and KWG 0519 Residue Method for Bovine Tissues 

and Milk: Project report No. 68887. Prepared by MOBAY CORPORATION. 67 p. 

92188047 Kruplak, J.; Weissenburger, B.; Bache (1990) Mobay Corporation Phase 3 Reformat of 

MRID 00063837. Determination of BAYLETON and KWG 0519 in Cattle Tissues: Project 

Report No. 68705. Prepared by ANALYTICAL DEVELOPMENT CORP. 31 p. 

92188048 Kruplak, J.; Bache, B.; Breault, G. (1990) Mobay Corporation Phase 3 Reformat of MRID 

00072538. Residue Analysis Procedure for the Determination of BAYLETON and KWG 

0519 in Bovine Milk: Project Report No. 68798. Prepared by ANALYTICAL 

DEVELOPMENT CORP. 19 p. 

92188051 Premkumar, N. (1990) Mobay Corporation Phase 3 Summary of MRID 00025541 and 

Related MRIDs 00098117, 41027902. Storage Stability of BAYLETON, BAYTAN, KWG 

1323 and KWG 1342 in Apple Peel, Potatoes, Grapes and Wheat Green Forage; and Storage 

Stability of KWG 1323 and KWG 1342 in Wheat Grain: Project Report Nos. 54192, 80338 

and 98432. Prepared by MOBAY CORPORATION. 11 p. 

92188052 Thornton, J. (1990) Mobay Corporation Phase 3 Reformat of MRID 00025541. The Stability 

of BAYLETON and KWG 0519 Residues in Apple Peel During Frozen Storage: Project 

Report No. 54192. Prepared by MOBAY CORPORATION. 8 p. 

92188053 Fredrickson, D. (1990) Mobay Corporation Phase 3 Reformat of MRID 00098117. The 

Stability of BAYLETON and BAYTAN Residues in Wheat Forage During Storage: Project 

Report No. 80338. Prepared by MOBAY CORPORATION. 7 p. 

92188054 Bornatsch, W. (1990) Mobay Corporation Phase 3 Summary of MRID 00090021. Effect of 

Feeding BAYLETON and the Metabolite KWG 0519 (BAYTAN) to Dairy Cattle -- Total 

Residue: Project Report No. 69930. Prepared by MOBAY CORPORATION. 9 p. 

92188055 Kruplak, J. (1990) Mobay Corporation Phase 3 Reformat of MRID 00090021. Effect of 

Feeding BAYLETON and the Metabolite KWG 0519 (BAYTAN) to Dairy Cattle -- Total 

Residues: Project Report No. 69930. Prepared by ANALYTICAL DEVELOPMENT CORP. 

247 p. 

92188056 Mathew, A. (1990) Mobay Corporation Phase 3 Summary of MRID 00090022. Effect of 

Feeding BAYLETON and the Metabolite KWG 0519 (BAYTAN) to Poultry - Total 

Residue: Project No. 80281. Prepared by MOBAY CORPORATION. 12 p. 

92188057 Kruplak, J.; Weissenburger, B. (1990) Mobay Corporation Phase 3 Reformat of MRID 

00090022. Effect of Feeding BAYLETON and the Metabolite KWG 0519 (BAYTAN) to 

Poultry - Total Residues: Project Report No. 80281. Prepared by ANALYTICAL 

DEVELOPMENT CORP. 174 p. 

92188060 Leslie, W. (1990) Mobay Corporation Phase 3 Summary of MRID 00067381 and Related 

MRIDs 00109463. Triadimefon (BAYLETON 25WP Formulation) - Magnitude of the 

Residues on Chick Peas: Project Report Nos. 68905, 68906, 68907, 68908, 68909, 80723, 

80930 and 80931; Mobay Report No. 100117-1. Prepared by MOBAY CORPORATION. 13 

p. 
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MRID Citation Reference 

92188061 Biehn, W. (1990) Mobay Corporation Phase 3 Summary of MRID 00143953 and Related 

MRIDs 00153279. Triadimefon: Magnitude of the Residue on Raspberries: IR-4 No. 2552. 

Prepared by ICI Americas Inc. 20 p. 

92188062 Leslie, W. (1990) Mobay Corporation Phase 3 Summary of MRID 00072532 and Related 

MRIDs 00149342. Triadimefon (BAYLETON 50WP Formulation) - Magnitude of the 

Residues on Seed Grass: Project Report Nos. 80670, 80673, 80674, 80675 and 80676; 

Mobay Report No. 100114-1. Prepared by MOBAY CORPORATION. 12 p. 

92188063 Leslie, W. (1990) Mobay Corporation Phase 3 Summary of MRID 00128337. Triadimefon 

(BAYLETON 50WP Formulation) Magnitude of the Residues on Sugar Beets: Project 

Report Nos. 81198, 81199, 82800, 82801, 82802, 82803, 82804, 82805, 82806, 82807, 

82808, 82809, 82811, 82814, 82815, 82816, 82817 and 82818; Mobay Report 100115-1. 

Prepared by MOBAY CORPORATION. 17 p. 

92188064 Leslie, W. (1990) Mobay Corporation Phase 3 Summary of MRID 00098114 and Related 

MRIDs 00149329, 00061736. Magnitude of the Residues on Wheat: Objective No. (3012): 

Report Nos. 80494, 80495, 80530, 80542, 80545, 80546, 80547, 80550, 80551, 80552, 

80553, 82821, 82874, 84208, 82822 and 82824; Mobay Report No. 100111-1. Prepared by 

MOBAY CORPORATION. 14 p. 

92188065 Leslie, W. (1990) Mobay Corporation Phase 3 Summary of MRID 00128337. Triadimefon 

(BAYLETON 50WP Formulation) - Magnitude of the Residue in Unprocessed Sugar Beets 

and Sugar Beet Processed Products: Project Report Nos. 84211, 84212 and 82811; Mobay 

Report No. 100116-1. Prepared by MOBAY CORPORATION. 12 p. 

92188069 Leslie, W. (1990) Mobay Corporation Phase 3 Reformat of MRID 00128337. Triadimefon 

(BAYLETON 50WP Formulation) - Magnitude of the residues in Unprocessed Sugar Beets 

and Sugar Beet processed Products: Project Nos. (82811, 84211, 84212); Mobay Report No. 

100116. Prepared by MOBAY CORPORATION. 56 p. 

92188070 Leslie, W. (1990) Mobay Corporation Phase 3 Reformat of MRID 00067381 and Related 

MRIDs 00109463. Triadimefon (BAYLETON 25WP Formulation) - Magnitude of the 

Residues on Chick Peas (Project Nos. 68905, 68906, 68907, 68908, 68909, 80723, 80930, 

80931); Mobay Report No. 100117. Prepared by MOBAY CORPORATION. 55 p. 

92188073 Leslie, W. (1990) Mobay Corporation Phase 3 Reformat of MRID 00128337. Triadimefon 

(BALETON 50WP) - Magnitude of the Residues on Sugar Beets: (Project Nos. 81198, 

81199, 82205, 82206, 82207, 82800, 82801, 82802, 82812, 82813, 82814, 82815, 82816, 

82817, 82818); Mobay Report No. 10115. Prepared by MOBAY CORPORATION. 204 p. 

92188074 Leslie, W. (1990) Mobay Corporation Phase 3 Reformat of MRID 00098114 and Related 

MRIDs 00149329, 00061736. Triadimefon (BAYLETON 50WP Formulation) - Magnitude 

of the Residues on Wheat: (Report Nos. 80494, 80495, 80530, 80542, 80545, 80546, 80547, 

80550, 80551, 80552, 80553, 82821, 82874, 84208, 82822, 82824); Mobay Report No. 

100111. Prepared by MOBAY CORPORATION. 219 p. 

92188075 Leslie, W. (1990) Mobay Corporation Phase 3 Reformat of MRID 00072532 and Related 

MRIDs 00149342. Triadimefon (BAYLETON 50WP Formulation) - Magnitude of the 

Residues on Seed Grass: Project Report Nos. (80670, 80673, 80674, 80675, 80676, 82848, 

82854, 82855, 82856, 82857, 82858); Mobay Report 100114. Prepared by MOBAY 

CORPORATION. 121 p. 
112

MRID Citation Reference 

92188320 Bayer Ag Institute of Toxicology; Two Generation Study with Rats; Report No.: 12712, 

Report Author: Dr. R. Eiben (Also under MRIDs 00155075, 92188019 and TRID Number 

470102-011). 

Allen, J., Wolf, D., George, M. Hester, S., Sun G., Thai, S-F., Delker, D., Nelson, G., 

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Crofton, KM., Boneck, VM., and Reiter, LW. 1988. Hyperactivity induced by triaedimefon, 

a triazole fungicide. Fundam. Appl. Toxicol. 10, 459-465. 

Crofton, KM., Boneck, VM., and MacPhail, RC. 1989. Evidence for monoaminergic 

involvement in triadimefon- induced hyperactivity, Psychopharmacology 97, 326-330. 

Crofton, KM., Howard, JL., Moser, VC., Gill, MW., et al. 1991. Interlaboratory comparison 

of motor activity experiments: implications for neurotoxicological assessments. 

Neurotoxicol. Teratol. 13 (6): 599- 609. 

Crofton, KM., Makris, SL., Sette, WF., Mendez, E., and Raffaele, KC. 2004. A qualitative 

retrospective analysis of positive control data in developmental neurotoxicity studies. 

Neurotoxicology and Teratology 26; 345-352.352. 

Goetz, A.K., Blystone, C., Ren, H., Schmid, J.E., Nichols, H.P., Bao, W., Best, D.S., 

Narotsky, M.G., Wolf, D.C., Rockett, J.C., and Dix, D.J. (2005) Reproductive Effects of 

Exposure to Conazole Fungicides in the Male Rat. The Toxicologist. Abstract No 2148. 

Golub, M., Costa, L., Crofton, K., Frank, D., Fried, P., Gladen, B., Henderson, R., Liebelt, 

E., Lusskin, S., Marty, S., Rowland, A., Scialli, J., and Vore, M. 2005. NTP-CERHR expert 

panel report on the reproductive and developmental toxicity of methylphenidate. Birth 

Defects Research (part B) 74:300-381. 

Hester, S., Thai, S.-F., Wolf, D., Ward, W., and Nesnow, S. (2005) Comparison of Gene 

Expression Profiles from Rats Fed Acute Levels of Three Toxicologically Different 

Conazoles. The Toxicologist. Abstract No. 2149. 

Ikaiddi, MU., Akunne, HC., and Soliman, KE. 1997. Behavioral and neurochemical effects 

of acute and repeated administration of triadimefon in the male rat. Neurotoxicology 18(3): 

771-80. 

Moser, VC and MacPhail, RC. 1989. Neurobehavioral effects of triadimefon, a triazole 

fungicide, in male and female rats. Neurotoxicol. Teratol. 11, 285-293. 

Moser, VC and MacPhail, RC. 1992. International validation of the neurobehavioral 

screening battery: The IPCS/WHO collaborative study. Toxicol. Lett. 64-65 Spec. No., 217-

223. 

None 

None 

None 

None 

None 

None 

None 

None 

None 

None 

None 

None 

None 

Moser, VC., Cheek, BM., and MacPhail, RC. 1995. A multidisciplinary approach to 

toxicological screenings: III. Neurobehavioral toxicity. Journal Toxicol Environ Health Jun 

45(2): 173-210. 
113

MRID Citation Reference 

None 

Ren, H., Schmid, J.E., Retief, J., Turpaz, Y., Zhang, X., Jones, P.D., Newsted, J.L., Giesy, 

J.P., Wolf, D.C., Wood, C.R., Bao, W., and Dix, D.J. (2005) Profiling Gene Expression in 

Human H295R Adrenocortical Carcinoma Cells and Rat Testes to Identify Pathways of 

Toxicity for Conazole Fungicides. The Toxicologist. Abstract No. 2150. 

Sun G, Thai SF, Tully DB, Lambert GR, Goetz AK, Wolf DC, Dix DJ, Nesnow S: 

Propiconazole-induced cytochrome P450 gene expression and enzymatic activities in rat and 

mouse liver. Tox Lett 155: 277-287, 2004; and abstracts from the 2005 SOT meeting, 

Walker, QD and Mailman, RB. 1996. Triadimefon and triadimenol: effects on monoamine 

uptake and release. Toxicol. Appl. Pharmacol. 139 (2): 227- 233. 

Ward, W., Delker, D., Hester, S., Thai, S-F., Allen, J., Jones, C., Wolf, D., and Nesnow, S. 

(2005) Comparison of Hepatic Gene Expression Profiles from Mice Exposed to Three 

Toxicologically Different Conazoles. The Toxicologist. Abstract No. 2147. 

None 

None 

None 

None Wolf, D.C., Allen, J., Sun, G., Thibodeaux, J., George, M., Hester, S.D., Thai, S.-F., Delker, 

D., Nelson, G., Winkfield, E., Roop, B., Leavitt, S., Ward, W., and Nesnow, S. (2005) 

Triadimefon Induces Rat Thyroid Tumors Through a Non-TSH Mediated Mode of Action. 

The Toxicologist. Abstract No. 2144. 
114

Appendix E. Generic Data Call-In 
115

Appendix E. 

The generic data call-in will be posted at a later date. 
116

Appendix F. Product Specific Data Call-In 
117

Appendix F. 

The product specific data call-in will be posted at a later date.
118

Appendix G: Batching of Triadimenol/Triadimefon Products

EPA'S BATCHING OF TRIADIMENOL/TRIADIMEFON PRODUCTS FOR MEETING 

ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION 

In an effort to reduce the time, resources and number of animals needed to fulfill the 

acute toxicity data requirements for reregistration of products containing TRIADIMENOL or 

TRIADIMEFON as the active ingredient, the Agency has batched products which can be 

considered similar for purposes of acute toxicity. Factors considered in the sorting process 

include each product's active and inert ingredients (identity, percent composition and 

biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable 

powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary 

labeling, etc.). Note that the Agency is not describing batched products as "substantially 

similar" since some products within a batch may not be considered chemically similar or 

have identical use patterns. 

Using available information, batching has been accomplished by the process 

described in the preceding paragraph. Notwithstanding the batching process, the Agency 

reserves the right to require, at any time, acute toxicity data for an individual product should 

the need arise. 

Registrants of products within a batch may choose to cooperatively generate, submit 

or cite a single battery of six acute toxicological studies to represent all the products within 

that batch. It is the registrants' option to participate in the process with all other registrants, 

only some of the other registrants, or only their own products within a batch, or to generate 

all the required acute toxicological studies for each of their own products. If a registrant 

chooses to generate the data for a batch, he/she must use one of the products within the batch 

as the test material. If a registrant chooses to rely upon previously submitted acute toxicity 

data, he/she may do so provided that the data base is complete and valid by today's standards 

(see acceptance criteria attached), the formulation tested is considered by EPA to be similar 

for acute toxicity, and the formulation has not been significantly altered since submission and 

acceptance of the acute toxicity data. Regardless of whether new data is generated or existing 

data is referenced, registrants must clearly identify the test material by EPA Registration 

Number. If more than one confidential statement of formula (CSF) exists for a product, the 

registrant must indicate the formulation actually tested by identifying the corresponding CSF. 

In deciding how to meet the product specific data requirements, registrants must 

follow the directions given in the Data Call-In Notice and its attachments appended to the 

RED. The DCI Notice contains two response forms which are to be completed and submitted 

to the Agency within 90 days of receipt. The first form, "Data Call-In Response," asks 

whether the registrant will meet the data requirements for each product. The second form, 

"Requirements Status and Registrant's Response," lists the product specific data required for 

each product, including the standard six acute toxicity tests. A registrant who wishes to 

participate in a batch must decide whether he/she will provide the data or depend on someone 

else to do so. If a registrant supplies the data to support a batch of products, he/she must 
119

select one of the following options: Developing Data (Option 1), Submitting an Existing 

Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study 

(Option 6). If a registrant depends on another's data, he/she must choose among: Cost 

Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If 

a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6. 

However, a registrant should know that choosing not to participate in a batch does not 

preclude other registrants in the batch from citing his/her studies and offering to cost share 

(Option 3) those studies. 

Seven products were found which contain Triadimenol as the active ingredient. These 

products have been placed in a no batch group in accordance with the active and inert 

ingredients and type of formulation 

 

Batching Instructions for Triadimenol: 

No Batch: Each product in this Batch should generate their own data. 

NOTE: The technical acute toxicity values included in this document are for informational 

purposes only. The data supporting these values may or may not meet the current acceptance 

criteria. 

No Batch EPA Reg. No. Percent Active Ingredient 

264-742 25.00 

264-743 98.30 

264-760 28.30 

264-939 Triademinol: 5.00 

Tetramethylthiuram disulfide: 15.30 

264-941 30.00 

264-980 Triademinol: 13.33 

Azoxystrobin: 8.00 

Metalaxyl: 40.00 

2935-459 30.00 

Fifty one products were found which contain Triadimefon as the active ingredient. These 

products have been placed in seven batches and a no batch group in accordance with the 

active and inert ingredients and type of formulation. 

Batching Instructions for Triadimefon: 

Batch 3A: Products in this Batch may cite studies conducted on products in Batch 3. 

Batch 6: Each product in this Batch must conduct a primary eye irritation study using the 

fertilizer with the highest percentage of nitrogen. 
120

No Batch: Each product in this Batch should generate their own data. 

NOTE: The technical acute toxicity values included in this document are for informational 

purposes only. The data supporting these values may or may not meet the current acceptance 

criteria. 

Batch 1 EPA Reg. No. Percent Active Ingredient 

264-737 50.0 

264-740 50.0 

432-1294 50.0 

432-1360 50.0 

432-1367 50.0 

Batch 2 EPA Reg. No. Percent Active Ingredient 

432-1293 25.0 

432-1309 25.0 

432-1316 25.0 

432-1317 25.0 

Batch 3 EPA Reg. No. Percent Active Ingredient 

4-342 1.0 

432-1295 1.0 

432-1336 1.0 

961-354 1.0 

8378-55 1.0 

9198-111 1.0 

10404-58 1.0 

28293-278 1.0 

32802-41 1.0 

34704-802 1.0 

Batch 3A EPA Reg. No. Percent Active Ingredient 

4-362 0.50 

432-1296 0.50 

869-224 0.50 

829-288 0.50 

961-353 0.50 

7401-432 0.50 

8378-54 0.50 

8660-199 0.78 
121

9198-112 0.50 

9198-187 0.59 

28293-280 0.50 

32802-42 0.50 

72155-47 0.50 

Batch 4 EPA Reg. No. Percent Active Ingredient 

432-1297 0.88 

829-289 0.88 

72155-48 0.88 

Batch 5 EPA Reg. No. Percent Active Ingredient 

869-222 0.88 

2724-691 0.88 

Batch 6 EPA Reg. No. Percent Active Ingredient 

961-388 0.10 

961-389 0.05 

9198-190 0.62 

10404-65 0.50 

No Batch EPA Reg. No. Percent Active Ingredient 

264-736 97.70 

264-757 Triadimefon: 2.10 

Sulfur: 53.70 

432-1300 22.00 

432-1412 Triadimefon: 8.33 

Trifloxystrobin: 41.67 

432-1445 43.00 

432-1446 Triadimefon: 20.86 

Trifloxystrobin: 4.17 

9198-169 Triadimefon: 16.00 

Metalaxyl: 16.00 

9198-197 Triadimefon: 1.59 

Thiram: 40.76 

64014-3 0.88 

72155-46 1.00 
122

H. List of Registrants Sent this Data Call-In 

United States Environmental Protection Agency 

Washington, D.C. 20460 

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE 

Case # and Name: 2700, Triadimefon 

Co. 

Number 

Company Name Agent for Address City and State Zip 

264 BAYER 

CROPSCIECNCE 

 

2 T.W. Alexander 

Drive 

Research Triangle 

Park 

NC 27709 

 
123

Appendix I. List of Available Related Documents and Electronically Available Forms 

 

Pesticide Registration Forms are available at the following EPA internet 

site: 

 http://www.epa.gov/opprd001/forms/. 

Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader) 

Instructions

 1. Print out and complete the forms. (Note: Form numbers that are bolded can be 

filled out on your computer then printed.) 

 2. The completed form(s) should be submitted in hardcopy in accord with the 

existing policy. 

 3. Mail the forms, along with any additional documents necessary to comply 

with EPA regulations covering your request, to the address below for the 

Document Processing Desk. 

DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive 

Information.' 

If you have any problems accessing these forms, please contact Nicole Williams at (703) 

308-5551 or by e-mail at williams.nicole@epamail.epa.gov. 

The following Agency Pesticide Registration Forms are currently available via the internet: 

at the following locations: 

8570-1 Application for Pesticide 

Registration/Amendment 

http://www.epa.gov/opprd001/forms/8570-1.pdf. 

8570-4 Confidential Statement of Formula http://www.epa.gov/opprd001/forms/8570-4.pdf. 

8570-5 Notice of Supplemental Registration of 

Distribution of a Registered Pesticide 

Product 

http://www.epa.gov/opprd001/forms/8570-5.pdf. 

8570-17 Application for an Experimental Use Permit http://www.epa.gov/opprd001/forms/8570-17.pdf. 

8570-25 Application for/Notification of State 

Registration of a Pesticide To Meet a Special 

Local Need 

http://www.epa.gov/opprd001/forms/8570-25.pdf. 

8570-27 Formulator's Exemption Statement http://www.epa.gov/opprd001/forms/8570-27.pdf. 

8570-28 Certification of Compliance with Data Gap 

Procedures 

http://www.epa.gov/opprd001/forms/8570-28.pdf. 

8570-30 Pesticide Registration Maintenance Fee 

Filing 

http://www.epa.gov/opprd001/forms/8570-30.pdf. 

8570-32 Certification of Attempt to Enter into an 

Agreement with other Registrants for 

Development of Data 

http://www.epa.gov/opprd001/forms/8570-32.pdf. 
124

8570-34 Certification with Respect to Citations of 

Data (in PR Notice 98-5) 

http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf. 

8570-35 Data Matrix (in PR Notice 98-5) http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf. 

8570-36 Summary of the Physical/Chemical 

Properties (in PR Notice 98-1) 

http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf. 

8570-37 Self-Certification Statement for the 

Physical/Chemical Properties (in PR Notice 

98-1) 

http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf. 

Pesticide Registration Kit www.epa.gov/pesticides/registrationkit/. 

Dear Registrant: 

 For your convenience, we have assembled an online registration kit which contains 

the following pertinent forms and information needed to register a pesticide product with the 

U.S. Environmental Protection Agency's Office of Pesticide Programs (OPP): 

 1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the 

Federal Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food 

Quality Protection Act (FQPA) of 1996. 

 

 2. Pesticide Registration (PR) Notices 

 a. 83-3 Label Improvement Program--Storage and Disposal Statements 

 b. 84-1 Clarification of Label Improvement Program 

 

 c. 86-5 Standard Format for Data Submitted under FIFRA 

 

 d. 87-1 Label Improvement Program for Pesticides Applied through 

Irrigation Systems (Chemigation) 

 e. 87-6 Inert Ingredients in Pesticide Products Policy Statement 

 f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement 

 g. 95-2 Notifications, Non-notifications, and Minor Formulation 

Amendments 

 h. 98-1 Self Certification of Product Chemistry Data with Attachments 

(This document is in PDF format and requires the Acrobat reader.) 

 Other PR Notices can be found at http://www.epa.gov/opppmsd1/PR_Notices. 

 3. Pesticide Product Registration Application Forms (These forms are in PDF 

format and will require the Acrobat reader.) 

 

 a. EPA Form No. 8570-1, Application for Pesticide 

Registration/Amendment 

 b. EPA Form No. 8570-4, Confidential Statement of Formula 
125

 c. EPA Form No. 8570-27, Formulator's Exemption Statement 

 d. EPA Form No. 8570-34, Certification with Respect to Citations of 

Data 

 e. EPA Form No. 8570-35, Data Matrix 

 4. General Pesticide Information (Some of these forms are in PDF format and 

will require the Acrobat reader.) 

 a. Registration Division Personnel Contact List 

I. b. Biopesticides and Pollution Prevention Division (BPPD) Contacts 

 c. Antimicrobials Division Organizational Structure/Contact List 

 d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data 

Requirements (PDF format) 

 e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices 

(PDF format) 

 f.. 40 CFR Part 158, Data Requirements for Registration (PDF format) 

 g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 

27, 1985) 

Before submitting your application for registration, you may wish to consult some 

additional sources of information. These include: 

 1. The Office of Pesticide Programs' Web Site 

 2. The booklet "General Information on Applying for Registration of Pesticides 

in the United States", PB92-221811, available through the National Technical 

Information Service (NTIS) at the following address: 

 National Technical Information Service (NTIS) 

 5285 Port Royal Road 

 Springfield, VA 22161 

The telephone number for NTIS is (703) 605-6000. 

 3. The National Pesticide Information Retrieval System (NPIRS) of Purdue 

University's Center for Environmental and Regulatory Information Systems. 

This service does charge a fee for subscriptions and custom searches. You can 

contact NPIRS by telephone at (765) 494-6614 or through their Web site. 

4. The National Pesticide Telecommunications Network (NPTN) can provide 

information on active ingredients, uses, toxicology, and chemistry of 

pesticides. You can contact NPTN by telephone at (800) 858-7378 or through 

their Web site: ace.orst.edu/info/nptn. 
126

The Agency will return a notice of receipt of an application for registration or 

amended registration, experimental use permit, or amendment to a petition if 

the applicant or petitioner encloses with his submission a stamped, selfaddressed postcard. The postcard must contain the following entries to be 

completed by OPP: 

• Date of receipt; 

• EPA identifying number; and 

• Product Manager assignment. 

 Other identifying information may be included by the applicant to link the 

acknowledgment of receipt to the specific application submitted. EPA will 

stamp the date of receipt and provide the EPA identifying File Symbol or 

petition number for the new submission. The identifying number should be 

used whenever you contact the Agency concerning an application for 

registration, experimental use permit, or tolerance petition. 

To assist us in ensuring that all data you have submitted for the chemical are 

properly coded and assigned to your company, please include a list of all 

synonyms, common and trade names, company experimental codes, and other 

names which identify the chemical (including "blind" codes used when a 

sample was submitted for testing by commercial or academic facilities). 

Please provide a chemical abstract system (CAS) number if one has been 

assigned. 

Documents Associated with this RED 

 

 The following documents are part of the Administrative Record for this RED 

document and may be included in the EPA's Office of Pesticide Programs Public Docket. 

Copies of these documents are not available electronically, but may be obtained by 

contacting the person listed on the respective Chemical Status Sheet. 

 1. Health Effects Division and Environmental Fate and Effects Division Science 

Chapters, which include the complete risk assessments and supporting 

documents. 

 2. Detailed Label Usage Information System (LUIS) Report.