United States Preventi on, 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. 2700TABLE 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 Ri sk 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 fr om Triadimefon and Triadimenol .............................. 25

7. Pesticide and Pharmaceutical Co-E xposure Assessment for the Triazole

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

8. Cumulative Risk Assessment ...................................................................................... 29 9. Occupational Risk ........................................................................................................ 29a. 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 Reregistrati on 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 Wat er) 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 ............................................................................................................. 614. 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 Document s and Electronically Available Forms ....... 123i 

### 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 Kochii 

### 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 Survey s 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

LC 50 Median Lethal Concentration. A statistically derive d concentration of a substance that can be expected to ca use 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.

LD 50 Median Lethal Dose. A statisti cally 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

F g/g Micrograms Per Gram

F g/L Micrograms Per Liter mg/kg/day Milligram Per Kilogram Per Day mg/L Milligrams Per Liter MOE Margin of Exposureiii 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, Pe sticides 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 Q 1 * 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 (Registrat ions 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 Standard1 ABSTRACT

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

human health and environmental risk assessm ents for triadimefon and the dietary and aggregate assessments for triadimenol, and is issuing its risk manage ment reregistration

decision and tolerance reassessment. The risk assessments, which are summarized below, are based on the review of the required targ et database supporti ng 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 ch anges to its triadimefon registration including the voluntary deletion of all f ood (except pineapples) and reside ntial turf use, and a reduction of application rates and freque ncies. In doing so, this docum ent 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 intere sted parties, the Agency developed its risk management reregistration decision for uses of triadimefon and tole rance reassessment for

triadimenol. As a result of this review, EPA has determined that triadimefon-containing products are eligible for reregistration, provide d that risk mitigation measures are adopted and labels are amended accordingly. Furtherm ore, 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 th e reregistration of products with active ingredients registered prior to Novemb er 1, 1984. The amended Act calls for the development and submission of data to support th e reregistration of an active ingredient, as

well as a review of all submitte d data by the EPA. Reregist ration involves a thorough review

of the scientific database unde rlying a pesticide's registration. The purpose of the Agency's review is to reassess the potential risks aris ing 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 Protecti on Act of 1996 (FQPA) was signed into

law. This Act amends FIFRA and the FFDCA to require reassessm ent of all existing tolerances for pesticides in f ood. FQPA also requires EPA to re view all toleranc es in effect on August 2, 1996, by August 3, 2006. In reassessi ng these tolerances, the Agency must consider, among other things, aggregate risks from non-occupational sources of pesticide exposure, whether there is increased susceptibi lity to infants and child ren, 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 concer n and the Agency concludes that there is a reasonable certainty of no harm from aggreg ate exposure, the tolerances are considered2 reassessed. EPA decided that, for those chemi cals that have tolera nces and are undergoing reregistration, tolerance r eassessment will be accomplished through the reregistration

process. As mentioned above, FFDCA requires th at 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. Po tential cumulative effects of chemicals with a common mechanism of toxicity are considered because low- level exposures to multiple

chemical substances that cause a common toxi c 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. Tria dimefon belongs to a group of pesticides called triazoles (or conazoles), which also includes the triazole fungi cide subject to reregistration, propiconazole. Triadimenol, a meta bolite of triadimefon, is also a registered fungicide and is subject to tolerance reassessment. For the purpo se of this reregistra tion eligibility decision (RED) for triadimefon and tolerance reassessm ent for triadimenol, EPA has concluded that

triadimefon and triadimenol do not share a common mechanism of toxicity with other substances. However, the triazole fungici des share common metabolites, the triazole compounds 1,2,4-triazole (free triazo le), triazole alanine, and tr iazole 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 re leased by EPA’s Office of Pesticide Programs concerning common mechanism determinations a nd 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 metabolite s of toxicological concern; these include 1,2,4-triazole and the conjugates triazole alan ine 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 tria dimefon 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 – 2 nd 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 Reregistra tion and Registration Actions for Triazole-deriv ative 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 fu rther in this document. For more information regarding the aggregate assess ment of free triazoles, see the July 18, 2006, document, Reregistration Eligibility D ecision (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 co mpounds. Thus, EPA must consider the incremental impact of exposur e 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 regula tory authority for drug products, to assess3 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 appr opriate measures are needed to reduce exposure from one or both sources of 1,2,4-triazole residues.

This document presents a summary of EP A’s revised human health and ecological risk assessments, its reregistration eligibil ity decision for triadi mefon and tolerance reassessment decision for triadimenol. Occupa tional and ecological risks from exposure to the pesticidal uses of triadimenol are not addr essed in this document. The document consists of six sections. Section I contains the regul atory framework for reregistration/tolerance reassessment. Section II provide s 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 in formation received in response to the preliminary risk assessments. Se ction IV presents the Agency’s reregistration eligibility, risk management and tolerance reassessment decisi ons. Section V summarizes label changes necessary to implement the risk mitigation m easures outlined in Section IV. Finally, the Appendices list related and s upporting documents. The revised risk assessments for

triadimefon and triadimenol are available in the Agency’s elect ronic 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, pineappl es, and raspberries. In additi on, it is used to control various fungal diseases on non-food use sites such as pi ne seedlings, Christmas trees, residential and commercial turf, ornamentals, and landscapes. There are tolerances for triadimefon on apples, grapes, pears, pinea pples, and raspberries. Tria dimefon end-use products are

marketed in the United States under the trad e names Bayleton and Summit. There are nineteen active products contai ning triadimefon (one technica l product) registered under

Section 3 of FIFRA.

The registrant has agreed to delete all f ood (except pineapple) and residential turf uses. Therefore, this Reregi stration 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 it s own active ingredient number (PC code:4 127201). Triadimenol is used exclusively in th e U.S. as a seed treatment for cotton and grains. As a result, it is al so 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(CH 3 ) 3

Common Name: Triadimefon

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

butanone

Chemical Family: Azole (Triazoles)

Empirical Formula: C 14 H 16 CLN 3 O 2

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 pr essure 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 O H CH 3 CH 3 CH 3

N N

N

Common Name: Triadimenol

Chemical Name: [beta-(4-chlorophenoxy)-al pha-(1,1-dimethylethyl)-1H-1,2,4- triazole-1-ethanol]

Chemical Family: Azole (Triazoles)

Empirical Formula: C 14 H 18 ClN 3 O 2

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 triazo le fungicides are metabolized in animals and plants to form compounds containing the tr iazole moiety, includi ng 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 aci d are formed by conjunction with an amino acid, they are referred to as triazole conjugates throughout this do cument. 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

NH 2 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: 127.107 C. Use Profile

1. Triadimefon

The following is information on the curren tly registered uses of triadimefon, including an overview of use site s and application methods. A de tailed table of the uses of

triadimefon eligible for reregistration is contained in Appendix A.

Type of Pesticide: Broad spectrum, system ic 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 voluntaril y 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 de leting residential turf use).

Formulation Type: Registered formulations include granular (G)(0.5-1% active ingredient), wetta ble powder (WP)(25-50% active ingredient), water soluble packets (50% active ingredient), liquid concen trate (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, ai rblast, aerial spray , chemigation, and broadcast (g ranular 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 applicati on rates are a 5.4 lb. ai/A treatment on turf (Californi a 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 pear s (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). Amaximum 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 fru it 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 tim e prior to planting.

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

Use Classification: General

2. Triadimenol

The following is information on the curren tly registered uses of triadimenol, including an overview of use site s and application methods. A de tailed table of the uses of

triadimenol eligible for tolerance reassessmen t 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 formulati ons include emulsifiable concentrate (EC) (5% activ e ingredient), wettable powder (WP)(25% active ingredient), soluble concentrate (SC) (13.33% active ingredient), and flowable concentrate (F lC) (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 Ag ency’s Biological and Economic Analysis Division. Total use averaged 135,000 lbs ai/yea r with an upper-end estimate of 266,000 lbs ai/year. The largest market, in terms of total pounds ai, was seen in th e turf and ornamental

sector.

2. Triadimenol

Based on pesticide usage data for the y ears 1992 through 2001, to tal annual domestic usage of triadimenol averaged approximatel y 24,000 pounds of active ingredient (a.i.) for over 12,000,000 acres treated. Use on cotton acc ounted for approximately 75 % of the total pounds of a.i. applied annually. Corn and wh eat accounted for approximately 20% and 5%, respectively. About 80% of U.S. acreage plante d to cotton is treated with triadimenol, and

less than 1 % of corn a nd wheat acres are treated

III. Summary of Risk Assessments

The following is a summary of EPA's human health and ecologica l 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, Pr obabilistic 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, 200610 • Triadimefon. Summary of Ana--lytical Chemistry and Residue Data for the Reregistration Eligibility Decision (RED) Document. November 23, 2005

• Triadimefon: Occupational and Residen tial Exposure Asse ssment for the Reregistration Eligibility Decision Document. June 30, 2006

• Triadimefon and Triadimenol: Aggregat e Acute, Chronic, and Short-Term Risk Assessments Reflecti ng July, 2006 Risk Mitiga tion 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 To lerance Reassessment Eligibility Decision (TRED) Docu ment (Revised). February 9, 2006

• Triadimenol. Acute and Chronic Diet ary 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 be tter understand the risk management decisions reached by the Agency. The human health a nd ecological risk assessment documents and supporting information listed in Appendix C were used to reach the safety finding and regulatory decisions for triadi mefon and triadimenol. Althou gh the risk assessments and

related addenda are not included in this documen t, they are available from the OPP Public Docket OPP-2005-0258 and OPP-2006-0038, and ma y 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 incorporat es potential exposure from all sources, which for triadimefon includes food, drinking wate r, residential, and occupational scenarios and for triadimenol include food and drinking water scenarios. A ggregate assessments combine food, drinking water, a nd any residential or other n on-occupational (if applicable) exposures to determine potential ex posures 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 f ood commodities, including animal byproducts. 1,2,4-Triazole appears to be re latively stable in the environment, and may be found in rotational crops and drinking wa ter. 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-occu pational exposure resulting from triadimefon alone and11 from the triazole metabolites from all pestic ide sources. For triadi menol, since there are no residential uses, EPA considered exposure a nd risk from food and drinking water In addition, EPA has also considered potential co-exposure to free tri azoles resulting from pharmaceutical uses of triazole compounds. B ecause the risks associ ated with the free triazoles from all sources are all below the Agen cy’s level of concern, they are not discussed

further in this document. Additional details regarding the risks asso ciated with the free triazoles, which includes contribution from tr iadimefon and triadimenol,- may be found in the February 7, 2006, document, 1,2,4-Triazole, Triazole Alanin e, Triazole Acetic Acid: Human Health Aggregate Risk Assessment in Support of Reregistra tion 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 predic t whether a pesticide could cause adverse health effects in humans (includi ng 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 addi tion, 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 tria dimefon; however, because it is a metabolite of triadimefon the Agency believes that the us e of data on triadimefon can be used for triadimenol and be protective regarding any poten tial risk concerns. Therefore, the Agency is not requiring a developmental neurotoxic ity (DNT) study for triadimenol. All other studies have been submitted to support guidelin e 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 nu mber EPA-HQ-OPP-2005-0258.

a. Acute Toxicity Profile

Triadimefon

Triadimefon is classified as category III fo r 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 pote ntial. In addition, tr iadimefon caused dermal sensitization in guinea pigs. The acute toxic ity 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. Add itional acute toxicity data may be required to determine appropriate cautionary label langua ge 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 LD 50 = 1,470 mg/kg (Males)

LD 50 = 1,090 mg/kg (Females) III

81-2 870.1200 Acute Dermal -

Rabbit 264276 LD 50 > 2,000 mg/kg III

81-3 870.1300 Acute Inhalation - rat 41616002 LC 50 > 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 se nsitizer. Triadimenol is an eye irritant with irritation clearing in 21 days or longer (toxicity Category II), a nd is a mild dermal irritant (toxicity Category IV). The acute toxicity profile fo r 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 LD 50 = 689 mg/kg (males)

LD 50 = 752 mg/kg (females) III

81-2 870.1200 Acute dermal –

rabbit 00145086 LD 50 > 2000 mg/kg III

81-3 870.1300 Acute inhalation –

rat 00145087 LC 50 > 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 Applicable13 b. FQPA Safety Factor Considerations

The FFDCA as amended by the FQPA dir ects the Agency, in setting pesticide tolerances, to use an additional tenfold (10X) ma rgin 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 resu lting 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 scenario s through which exposure to children or pregnant women is expected. A DNT study is required for triadime fon and the Agency will issue a DCI for this

data.

Triadimenol

The endpoint of concern for triadimenol, lik e triadimefon, is neur otoxicity, which was observed in rat, mice, and rabbit studies. Evidence of increase d susceptibility to offspring

was not seen in available devel opmental 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 neurot oxicity 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, toxi cological endpoints, dose levels, and uncertainty/safety factors selected for the asse ssment of dietary, oral , dermal, and inhalation exposure to triadimefon. Sin ce no appropriate acute endpoint could be determined from the triadimenol database, the triadimefon subchroni c neurotoxicity study in rats was chosen for the acute reference dose (aRfD) for triadi menol, as well. In addition, the subchronic neurotoxicity study for triadimef on was also chosen for the chr onic reference dose (cRfD) for triadimenol. Therefore, the endpoint of concer n 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 adve rse effect level; LOAEL, lowest observable adverse effect level; RfD, reference dose, e xposure which is not expected to exceed EPA’s level of concern; PAD, population adjusted dose, which is the RfD adjusted for the FQ PA 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, toxi cological endpoints, dose levels, and uncertainty/safety factors selected for the assessment of dietar y exposure to triadimenol. The endpoint of concern is neurotoxic ity (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 Comm ittee (CARC) assigned triadimefon a classification of "possible human car cinogen", using the criteria in the Draft Guidelines for Carcinogen Risk Asse ssment (July, 1999) . This classification is based on a statistically significant increase in thyroid adenomas in ma le Wistar rats and statistically significant increases in hepatocellular adenomas in both sexes of the NMRI mouse. However, the Agency concluded that a quantified carcinogen ic risk assessment for triadimefon is not appropriate and risk assessment will be ba sed on the chronic population adjusted dose (cPAD) and margin of exposure (MOE) approaches only.

Triadimenol

The CARC has assigned tria dimenol a classification of “possible human carcinogen”, using the criteria in the Draft Guidelines for Carcinoge n Risk Assessment (July, 1999) . This

classification is based on increased inciden ce of hepatocellular adenomas in females. However, the Agency concluded that a qua ntified 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 ame nded by FQPA, to develop a screening program to determine whether certain substanc es (including all pes ticide active and other ingredients) “may have an eff ect 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 au thority to require the wildlife evaluations. As the science develops and resources allow, screening of a dditional 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 me diated toxicity.

4. Dietary Exposure and Risk

The registrant has agreed to voluntarily cancel all food (apples, pears, grapes, and raspberries), except pinea pple, and residential tu rf use for triadimefon 1 . Thus, these uses

were not included in this diet ary risk assessment. In a ddition, the registrant is only supporting a maximum turf rate of 2 applicatio ns 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 residu es from both food and drinking water. In examining dietary risk, exposures from the use of triadimefon, which includes the parent and its metabolites, includi ng triadimenol, as well as exposures from the use of triadimenol, which includes the parent an d 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) a nd therefore must be aggregated. To estimate dietary risks from food and drinking water, EPA compares the estimated exposure to pesticide residues in f ood 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 exce ed EPA’s level of con cern. Likewise, a risk

estimate that is less than 100% of the chroni c PAD (cPAD), the dose at which an individual could be exposed over the course of a life time and no adverse health effects would be expected, does not exceed EPA’s level of con cern. Additional details ab out 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 Di etary (Food + Drinking Water) Exposure and Risk Assessments for the Triadimefon Reregistration and in the February 9, 2006, document, Triadimenol: HED Chapter of the Toleran ce 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 triadimef on 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 resu lts >100% of the aPAD are above the Agency’s level of

concern. Refer to Table 3 above.

Chronic PAD . Combined dietar y risk for triadimefon and triadimenol was assessed by comparing chronic dietary exposure estimate s (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-speci es extrapolation, 10X for intra-species variability, and 10X FQPA safety factor for database uncertainty- lack of a developmental neurotoxicity study) . Therefore, the cPAD for tr iadimefon 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 subc hronic neurotoxicity study in rats, which accounted for the most sensitive species and en dpoints (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 incorpor ates 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-Carl o) acute dietary exposure assessment was conducted

based on field trial data and 100% crop treated (%CT) at the 95 th percentile. The risk assessment combined exposure for both triadi mefon and triadimenol. Acute dietary (food only) risk estimates were based on field tr ial data for pineapples (triadimefon and triadimenol) and bananas (triadim enol), plus seed treatment us es on cotton and grain (barley, corn, oats, rye, sorghum, and wheat) from tria dimenol based on a tole rance 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 95 th percentile exposure for children 1-2 years old at 32% of the aPAD, the most highly exposed population subgroup. The 95 th percentile of exposure is the appropriate percentile to use gi ven the level of refinement (i .e., unrefined) of the residue values used and that 100% of the crops are assu med to be treated. Refer to Table 5 below.18 Table 5. Results of Acute Dietary Exposu re Analysis for Food Alone Using DEEMFCID

95 th 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 we re also conducted using the Dietary Exposure Evaluation Model software with th e 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 (triad imenol), plus seed treatment uses on cotton and grain (barley, corn, oats, ry e, sorghum, and wheat) from triadimenol using a tolerance level approach and assu ming 100% crop treated.

For all supported commodities, the chronic dietary exposure to triadimefon from food (only) is below the Agency’s level of con cern (<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 Expo sure 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 1019 b. Dietary Exposure from Drinking Water

Surface Water Exposure

Triadimefon and triadimenol can be tran sported 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 Fl orida turf use. This scenario was chosen because it is expected to present the gr eatest risk to drinking water supplies. Because water monitoring data for triadimefon are limited, th e 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 reside ntial and golf/sod turf. However, Bayer, the technical registrant, is only s upporting a maximum turf rate of 2 applications of 2.7 lbs. ai/A for golf courses and sod farms. As a result, onl y those results are presen ted 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 Tria dimefon and its Degradate Triadimenol in Surface Drinking Water Using PRZM/EXAMS Scenarios (Turf)

Chronic Concentration (ppb) Use Scenario Portion of Golf 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 ft 2 ) 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 SC I-GROW model (Tier 1 Ground Water Computer Model). In addition, groundwat er monitoring studies were su pplied by the registrant, Bayer CropScience. Although SciGrow should typi cally 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 monito ring 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 suppos ed. Although the ground water monitoring values were lower than su rface water modeled values, there may be an20 unforeseen risk to private shallow ground water wells used for drinking water in areas where triadimefon is applied. This may be furthe r 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 wa ter estimates in this case are considered protective for ground and/or drinking water contributions. Fo r more information on drinking water risks and representative calculations , see the Water Exposure/Risk Pa thway section of the revised human health risk assessment, dated February 9, 2006.

c. Dietary Risk fr om Drinking Water

Drinking water exposure to pesticides can occur through ground and surface water contamination. In assessing drinking water ri sks, 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 tr iadimenol (seed treatment) and the amount of pesticide available on a per acre basis, drinki ng water exposures result ing 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 tr iadimefon were calculated using the PRZMEXAMS model. The assessment also accounted fo r triadimenol as the primary degradate in

water. The PRZM-EXAMS assessment consider s 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 mob ile 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. Tria dimefon and triadimenol may also leach into groundwater when triadimefon is applied in ar eas 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 fa irly long half-lives in soil and water. The Agency modeled surface drinking water va lues 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 95 th percentile as the level of concern (LOC) for drinking water because the drinking water assessmen t 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 pe rcent cropped area (PCA)), and

therefore 100% of the watershed is turf treated with triadimef on; 2) residue estimates were modeled using PRZM-EXAMS, which usually resu lts in higher water concentration values than would monitoring data; 3) the dose sp acing between the NOAEL and LOAEL in the21 guideline acute and subchronic neur otoxicity studies is fairly la rge; and 4) the entire golf

course is assumed to be treated.

Acute dietary (water only) risk estimate s 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) fo r 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 Exposu re Analysis for Water (only) Using DEEMFCID

95 th 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 a nd its degradate triadimenol to determine risk values. The chronic dietary exposure to triadimefon from wa ter (only) is below the Agency’s level of concern (<100% cPAD) for the U.S. populat ion (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 Exposu re Analysis for Water (only) Using DEEMFCID

95 th 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 1222 5. Residential (Non-dietary) Exposure and Risk

Triadimefon

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

to toddlers.

Triadimenol

There are no residential us es of triadimenol products.

Currently, triadimefon products are mark eted for homeowner use on residential lawns, landscape ornamentals, and trees. Tria dimefon-containing products are also marketed for use by professional applicators (Pest Contro l 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 assesse d for the residential handler, and for postapplication dermal contact for adults, youths, and for toddler’s post-a pplication incidental oral exposure that may occur from turf cont act. Residential exposure may occur during and after application at homes, or afte r applications at golf courses, parks, schools, or other turf sites. Each route of exposure (oral, dermal , inhalation) is assesse d, 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 resident ial exposure and risk, refer to the document, Triadimefon: Occupational and Residential Ex posure Assessment fo r the Reregistration Eligibility Decision Document, dated June 30, 2006.

a. Residential Handler Risk

The anticipated use patterns and current labe ling indicate several residential handler exposure scenarios based on the types of equipmen t and techniques that can be used to make triadimefon applications. The quantitative shor t-term exposure/risk assessment developed

for residential handlers is based on these scenar ios. 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-E nd Sprayer (Residential ORETF data -- ornamental shrubs) (4) Wettable Powders with Hose-End Sp rayer (Residential ORETF data -- liquid concentrate application to ornamentals) (5) Liquid Concentrates w ith 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 residentia l handlers are not a concern fo r all residential uses of

triadimefon. Combined dermal and inhalation risks for residential ha ndlers are not a concern (MOEs >1000) for the following scenarios:

(1) Mixing/loading/applying liquid and wetta ble 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 c oncentrates/ 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 Re sidential Handler Risks

Baseline Unit Exposure MOEs

Exposure

Scenario Crop or Target App

Rate a (lb ai
/gallon) Area

Treated Daily b
(gallons) Dermal c

(mg/lb

ai) Inhalation d
(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 85024 Baseline Unit Exposure MOEs

Exposure

Scenario Crop or Target App

Rate a (lb ai
/gallon) Area

Treated Daily b
(gallons) Dermal c

(mg/lb

ai) Inhalation d
(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 previous ly 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 orna mental 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 triadi mefon when they are in areas that have been previously treated. Post-app lication exposure scenario s were developed for each residential setting where tr iadimefon can be used. The s cenarios 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 t oxicological endpoint of concer n. Risks to adults and youths are below the Agency’s level of concern (See Table 11 & 12 below).25 Table 11. Adult Residential Risk Esti mates 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 Estima tes 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 can cel 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 exposur e to toddlers.

Additional details regarding the residen tial exposure and risk assessments for triadimefon may be found in the following documents: Triadimefon. Occupational and Residential Exposure Assessment for the Rere gistration Eligibility Decision Document, dated June 30, 2006.

6. Aggregate Exposure/Risk from Triadimefon and Triadimenol

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

to determine “that there is a reasonable cert ainty that no harm will result from aggregate exposure to the pesticide chemical residue, in cluding all anticipated dietary exposures and other exposures for which there is reliable info rmation.” Aggregate exposure will typically include exposures from food, drinking water, re sidential uses of a pesticide, and other non-26 occupational sources of exposure. When aggregating exposure and risk from various sources, the Agency considers the ro ute and duration of exposure.

Acute (Food and Water)

The Agency believes it is appropriate to use the 95 th percentile as the level of concern (LOC) for the entire golf course becaus e it is a highly conser vative 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 tr iadimefon; 2) residue estimates were modeled using PRZM-EXAMS, which usually results in higher water concentr ation values than would monitoring data; 3) the dose spaci ng between the NOAEL and LOAEL in the guideline acute and subchronic ne urotoxicity studies for triadimefon are fairly large; and 4) the Agency assumes that the en tire golf course is treated.

Combined acute dietary (food and water) risk estimates from pineapples (triadimefon) and drinking water (triadimefon fr om golf course application to entire golf course) plus seed treatment uses and banana import tolerance (t riadimenol) are below the Agency’s level of concern (<100% aPAD) at the 95 th percentile of exposure (assuming 2 applications per year for turf at 2.7 lbs ai/A). Th e dietary exposure for acute food a nd 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 su mmary of acute dietary risk estimates (food + drinking water) is presen ted below in Table 13.

Table 13. Triadimefon and Triadimenol Resu lts of Acute Dietary Exposure Analysis for Food + Drinking Water From the Golf Co urse (entire) Use Scenario Using DEEMFCID

95 th 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 wate r) risk estimates were derived from pineapples and drinking water (e ntire golf course-triadimefon) pl us seed treatment uses and bananas import tolerance from triadimenol. Dr inking 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 a nd drinking water is below the Agency’s level

of concern and is 18% of the cPAD for th e 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 Chroni c Dietary Exposure Analysis for Food + Drinking Water From the Golf Co urse (entire) Using DEEM-FCID

95 th 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 drinki ng water) because at that time the dietary and residential exposure pathways separately exceeded th e Agency’s level of concern. The registrant agreed to voluntarily delete residentia l turf uses and all food uses (except pineapple) so that the aggregate risk s 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 fo r 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 ad ults and toddlers by calculating an aggregate risk MOE assuming background (chronic) exposur e to triadimefon and triadimenol residues from dietary (food and water) sources. The chronic exposure from drinking water considers treatment of an entire golf cour se. Short-term aggregate ris k, 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 assu ming 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 w ith a low pressure handwand to greenhouse ornamentals), aggregate (food + water + resident ial) risk is below the Agency’s level of concern (MOE = 1300).

The combined risk assessment for exposures to toddlers followi ng 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 these28 products must be restricted to not al low transplantation earlier than the 17 th 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 applica tions in residential settings. Therefore, intermediate-term chronic aggregate ri sk assessments were not conducted.

7. Pesticide and Pharmaceutical Co-Exposure Assessment for

The Triazole Metabolites

FFDCA Section 408 requires EPA to consid er potential sources of exposure to a pesticide and related substances in addition to the dietary sources expe cted to result from a pesticide use subject to a tolera nce (legal limit for pesticide re sidue levels) in food or feed commodities. In determining whether to ma intain a pesticide tolerance, EPA must

“determine that there is a reasonable certain ty of no harm...” in accordance with FFDCA, Section 408(b)(2)(A)(ii). The FDA regulates hum an 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 dietar y 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 meani ng of section 408 of the FFDCA.

Rather, EPA believes that an appropriate wa y 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 e xposure 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 imp act 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, triadime fon may share a common metabolite, 1,2,4- triazole, with triazole-derivative pharmaceu tical compounds. Thus, EPA consulted with FDA on triazole drugs that could metabolize to 1,2,4-triazole and th e Agencies concluded that only one compound, anastrozole, a chemot herapy 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 c onservative 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, th e 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 for29 pharmaceutical uses as described above. Therefore, EPA concludes that the potential dietary pesticide exposure to triazole pe sticide residues in food and wate r 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 dr ugs, (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 th e FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, th e Agency consider “available information” concerning the cumulative effects of a particular pesticide’s residues a nd “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 th e 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 subs tances. The Agency reached this conclusion after a thorough internal revi ew 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 shar e the common metabolit es 1,2,4-triazole, triazole alanine, and triazole acetic acid, which ar e considered in this RED.

9. Occupational Risk

The registrant has agreed to voluntarily de lete all uses on apples, pears, grapes, raspberries, and residential tu rf. Occupational post -application exposure a nd risk assessment for agricultural uses of triadime fon indicates that risks are not a concern at day 0 (i.e., 12 hours after application) for all use site s and all post-applic ation activities.

Workers can be exposed to a pesticide through various ro utes/pathways. There is potential for exposure to triadimefon in occ upational scenarios from handling triadimefon products during the application process (i.e., mixer/loaders, applic ators, flaggers, and mixer/loader/applicators), and a potential for post-application wo rker exposure from entering into areas previously treated with triadimef on. In addition, there is potential exposure to

workers who treat seed with triadimefon in co mmercial and nursery se ttings and to persons who plant treated seed. Occupa tional risk for all of these pot entially 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 exposu re at the time of application (termed “handler” exposure) and following applica tion (termed post-application exposure). Application parameters are generally defined by the physical nature of the formulation (e.g., formula and packaging), by the equipment require d to deliver the chemical to the use site, and by the application rate requir ed to achieve an efficacious dos e. Post-application risk is

assessed for activities such as scouting, irrigating, pruning, a nd harvesting, and is based primarily on dermal exposure estimates. Note that occupational risk estimates are intended30 to represent pesticide workers, and on this basis assumptions are made concerning acres treated per day and the seas onal duration of exposure.

Triadimenol is only being reviewed for to lerance reassessment purposes. Currently registered uses do not involve occupational expo sures. 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 Rere gistration Eligibility Decision Document, dated June 30, 2006; and the memorandum: Triadimefon/Triadime nol: 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 endpoi nts used in the triadimefon occupational risk assessment.

Table 15. Toxicological Endpoints for the Tr iadimefon 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 endpoint s and points of departur e (PODs) are identical to assess short and intermediate exposure, thes e risk estimates represent both durations of

exposure.

Occupational handler assessments are conducte d using increasing levels of protection. The Agency typically evaluates all exposures with minimal protecti on and then considers additional protective measures using a tiered appr oach in an attempt to obtain an adequate MOE. The lowest tier is represented by the baseline clothing scenar io (i.e., single layer clothing, socks, and shoes), followed by increasing levels of risk mitigation such as personal protective equipment (PPE) and engineering cont rols (EC). In the case of triadimefon, exposure to pesticide handlers is likely duri ng the occupational use of the pesticide in a variety of occupational environments. The anticipated use pattern s and current labeling indicate several occupational exposure scen arios based on the types of equipment and techniques that can potentia lly be used for triadimefon applications. Based on the use patterns, twenty-seven major occupational hand ler exposure scenarios (non-seed treatment) were identified. In addition, six major exposur e scenarios were identified for pine seed treatment. The following exposure scenarios we re used to develop the risk assessment for occupational handlers.

(Non-seed treatment)

Mixer/Loaders : (1a) Liquid Formulations to s upport Aerial Applications (PHED) (1b) Liquid Formulations to support Groundboom Applications (PHED) (1c) Liquid Formulations to s upport LCO Handgun Applications (PHED) (1d) Liquid Formulations to s upport Airblast Applications (PHED) (2a) Wettable Powders to support Aerial Applications (PHED) (2b) Wettable Powders to support Chemigation Applications (PHED) (2c) Wettable Powders to suppor t 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 Ri ghts-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 App lications (PHED) (3d) Water Dispersible Granules to support LCO Handgun Applications (PHED) (4a) Loading Granulars to suppor t 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 Spra y Applications (PHED) (11) Tractor-Drawn Spreader Granule Applications (PHED)

Flaggers : (12) Flagging for Aerial Spray Applications (PHED) (13) Flagging for Aerial Gr anular 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/planti ng 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 fl owables using cement mixer equipment (using PHED mixing/loading DF data), (S-5) on-nursery drying/ra king/bagging treated seed, (S-6) loading and applying wettable powder formulations with commercial seedtreatment equipment, (S-7) commercial sewer stit ching 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 du ring the usual use patterns associated with the pesticide’s use.33 In all non-seed treatment scenarios, combin ed dermal and inhalation MOEs meet or

exceed the level of concern of 100 at some le vel of risk mitigation (personal protective equipment or engineering controls ). In the majority of scenar ios where data are available,

combined dermal and inhalation risks are not a concern at baseline (l ong-sleeve shirt, long pants, shoes, socks, no respirator) or baseline plus chemical-resistant gloves. However, there are risk concerns requiring a dditional dermal or inhalation pr otection (e.g. a respirator or engineering controls) for several of the scen arios involving mixing/lo ading/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 th e required level of concern of 100 at baseline or baseline plus chemical-resistant gloves. Fo r commercial seed treatment, combined dermal

and inhalation risks meet or exceed th e required MOE of 100 with baseline PPE.34Table 16. Combined Dermal plus Inhalation Handler Risks for Agricultural and Commercial UsesCombined MOEsiExposureScenarioCrop orTargetApp Rate(lb ai/acre)aAreaTreatedDaily(acre)bBaselinecDermal+BaselineInhSinglelayer w/glovesdDermal +BaselineInhDoublelayer w/gloveseDermal +BaselineInhSinglelayerw/glovesDermal +80% RfInhSinglelayer w/glovesDermal +90% RgInhDoublelayer w/glovesDermal +80% RInhDoublelayer w/glovesDermal +90% R InhEngControlhDermal+ InhMixer/LoaderMixing/LoadingLiquidConcentrates forInjectionornamentals(shade trees,woodyshrubs)0.000026 lbai/inch oftrunkinch oftrunkNo Data No Data No Data No DataNo Data No Data No Data No DataChristmastrees0.25 350 30 60 61 250turf (sodfarm)2.7 (exceptCA)350 2.7 5.6 5.6 23 38 24 42 680Mixing/LoadingWettablePowders forAerialApplicationspine seedlings 0.5 350 15 30 30 130Mixing/LoadingWettablePowders forChemigationApplicationsturf (sodfarm)2.7 (exceptCA)350 2.7 5.6 5.6 23 38 24 42 680azaleas0.005 lbai/gallon16000gallons32 66 67 270turf (sodfarm)2.7 80 12 24 25 100Mixing/LoadingWettablePowders forGroundboomApplicationsturf (golfcourse)2.7 40 24 49 49 20035Combined MOEsiExposureScenarioCrop orTargetApp Rate(lb ai/acre)aAreaTreatedDaily(acre)bBaselinecDermal+BaselineInhSinglelayer w/glovesdDermal +BaselineInhDoublelayer w/gloveseDermal +BaselineInhSinglelayerw/glovesDermal +80% RfInhSinglelayer w/glovesDermal +90% RgInhDoublelayer w/glovesDermal +80% RInhDoublelayer w/glovesDermal +90% R InhEngControlhDermal+ InhMixing/LoadingWettablePowders toSupport Rightsof-way sprayerturf (golfcourse andsod farms)2.7 80 12 24 25 100ApplicatorChristmastrees0.25 350 No Data No Data No Data No Data No Data No Data No Data 20000turf (sodfarm)2.7 350 No Data No Data No Data No Data No Data No Data No Data 1900Applying Spraysvia AerialEquipmentpine seedlings 0.5 350 No Data No Data No DataNo Data No Data No Data No Data 10000ApplyingGranulars viaAerialEquipmentturf (sodfarm)2.6 350 No Data No Data No Data No Data No Data No Data No Data 200Mixer/Loader/Applicatorturf (golfcourse, sodfarms)2.7 5 No Data 15 15 53 79 58 92NotFeasibleMixing/Loading/ApplyingWettablePowders withLow PressureHandwand(PHED)pine seedlings 0.5 5 No Data 78 81 290NotFeasible36Combined MOEsiExposureScenarioCrop orTargetApp Rate(lb ai/acre)aAreaTreatedDaily(acre)bBaselinecDermal+BaselineInhSinglelayer w/glovesdDermal +BaselineInhDoublelayer w/gloveseDermal +BaselineInhSinglelayerw/glovesDermal +80% RfInhSinglelayer w/glovesDermal +90% RgInhDoublelayer w/glovesDermal +80% RInhDoublelayer w/glovesDermal +90% R InhEngControlhDermal+ InhMixing/Loading/ApplyingLiquids with anInjectorornamentals(shade trees,woodyshrubs)0.000075 lbai/1 inch oftrunkcircumferenceinch oftrunkcircumferenceNo Data No Data No Data No DataNo Data No Data No DataNotFeasibleMixing/Loading/Applying RTUBriquettepine seedlings0.00019 lbai/seedlingseedlings No Data No Data No Data NoData No Data No Data No DataNotFeasiblepine seed(nurseries)0.0000625lb ai/gallon100gallonsNo Data No Data No Data No Data NoData No Data No Data No DataMixing/Loading/Applying Dippineapple(post-harvest)0.0028 lbai/gallon100gallonsNo Data No Data No Data No Data NoData No Data No Data No Dataa 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 SACSOP #9 “Standard Values for Daily Acres Treated in Agriculture,” industry sources, andHED 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 shirtand 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/loadingsystem, enclosed cab, orenclosed 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) dr ying/raking/bagging treated pine s eed; and 4) ready-to-use (RTU) briquette applications to pine seedlings. Therefore, the Ag ency 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, appl es, pears, Christmas trees, pine seedlings, and raspberries. Because of the use pattern, a wi de array of individuals can potentially be exposed by working in areas that have been prev iously treated. However, the registrant has agreed to voluntarily delete all uses on apples, pears, grapes, ra spberries, 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-applicati on studies and lack of transfer coefficients for certain crop activities. However, the existing database is adequate to assess post-application risk.

Occupational risks were calcula ted using a MOE, which is a ratio of the daily dose to the toxicological endpoint of concern. Post-a pplication risks diminish over time because triadimefon residues eventually dissipate in the environment. Therefore, risks were calculated over time based on changing resi due levels. Occupati onal 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 applicatio n) for all use sites a nd all post-application activities. MOEs for occupati onal post-application risk rang e 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 Ag ency reviewed reports from the National Poison Control Centers (PCC), California Depart ment of Pesticide Re gulation (CDPR), the Agency’s Office of Pesticide Program’s Incide nt Data System (IDS), the National Pesticide Information Center (NPIC), the National Inst itute of Occupational Safety and Health’s Sentinel Event Notification System for Occ upational 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 expos ures 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 se en in a health care f acility and none required hospitalization. A review of symptoms rev ealed almost exclusively irritation effects (including rash and erythema) to skin, mouth, th roat, and eyes. In a ddition, there were four38 cases reporting headache and two reported c ough. 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%) invol ved use on grapes which is a labor intensive crop involving high exposure to foliar residues. Foliar residues accoun ted for half of the illnesses and nearly half of the systemic illne sses. Skin, eye irrita tion, and rash were among the most common topical symptoms. The most common systemic effects included nausea, headache, sneezing, congestion, difficulty breathing and other allergic-t ype reactions. In addition, there were three reports of vomiting. Furthermore, the registrant has voluntarily agreed to delete all food (apples, gr apes, 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 dur ing calendar years 1984-1991, inclusive has been prepared. The total number of calls was tabulat ed for the categories human incidents, animal incidents, calls for information, and others. Tr iadimefon was not reported on the list of the top 200 chemicals with incidents reported to NP IC. 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 expo sure to triadimefon. Irritation to skin, eyes, and respiratory passage occur readily am ong unprotected handler s (applicators and mixer/loaders) and among those who have subs tantial contact with foliage such as grape

harvesters and tenders. Additiona lly, it should be noted that tria dimefon 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 ra spberries) turf, pine seedlings, Christmas trees, and ornamentals. However, the re gistrant has agreed to voluntarily delete all use on apples, grapes, pears, raspberries, and re sidential turf. A summ ary of the Agency’s

environmental risk assessment for triadime fon 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 Tr iadimefon Risk Assessment , dated June 1, 2006. These documents may be accessed in the OPP Pub lic 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 de grades by photolysis in water with a halflife of 7.6 hours. In aerobic sandy loam soil, pare nt triadimefon degraded with a half life of 5.6 days, and in anaerobic sandy loam soil the ha lf 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 aqua tic) 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), a nd 1H-1,2,4-triazole (aerobic soil).

The environmental fate assessment was based on an evaluation of total triadimefon toxic residues, which include s both parent and the degr adate triadimenol. Since approximately 75% of parent triadimefon de graded to triadimenol within 60 days postapplication, for the purpose of modeling, physic al characteristics that reflected combined properties of both compounds in proper relative proportions were used. Thus, for example,

the aerobic soil half-life for total re sidues used in modeling was 240 days.

Both triadimefon and triadimenol were s hown to be moderately soluble, and are therefore capable of being transp orted dissolved in water as surface runoff or as leachate to groundwater. The adsorption coefficients (K oc ) for triadimefon and triadimenol were 387 L/kgoc and 365 L/kgoc (average of four soils), respectively. Tria dimenol 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 ir rigation 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 vari ety of environmental conditions. Therefore, triadimefon is likely to be of greater concer n for surface water runoff issues, but triadimenol is of greater concern for groundwat er and apt to be more persiste nt than parent triadimefon in most settings.

2. Ecological Exposure and Risk

To estimate potential ecological risk, EP A integrates the results of exposure and ecotoxicity studies using the risk quotient method. Risk quo tients (RQs) are calculated by dividing estimated environmental concentra tions (EECs), based on environmental fate characteristics and pesticide use data, by ecot oxicity 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 a nd 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 effect s 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 ecologi cal risks posed by the use of triadimefon, refer

to the “Environmental Fate and Effects Division R evised 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 usi ng technical triadimefon demons trate that it is slightly to moderately toxic to freshwater fish under acute exposure with LC 50 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 (LC 50 ) for triadimenol indicate that triadimenol is slightly toxic on an acute basis.

Tables 18 and 19 summarize the data that suppo rt the acute toxicity endpoints used in assessing the risks to freshwater fish. No tr iadimefon 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 LC 50 (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 LC 50 (ppm) Toxicity

Classification MRID No. Author/Year

Warm water fish (Bluegill sunfish, Lepomis

macrochirus ) 92 14 Slightly toxic 071469

Lamb/198141 For chronic toxicity, a freshwater fish early life-stage test using technical triadimefon

showed that the most sensitiv e species is the rainbow tr out, with a NOAEL of 41 ppb (0.041 ppm). However, no chronic fres hwater fish toxicity data we re available for the degradate triadimenol. In addition, no triadimefon or triadi menol estuarine/marine fish chronic toxicity

tests were submitted. Table 20 summarizes the da ta for the chronic toxicity endpoints used in assessing the risks to freshwater fish.

Table 20. Early Life-Stage Chronic Toxi city 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 usi ng technical triadimefon demons trate that it is slightly to moderately acutely toxic to freshwater invertebrates, with LC 50 values ranging from 1.6 to 11.3 ppm. Freshwater invertebrate acute toxicity tests were also performed for the degradate triadimenol, resulting in an LC 50 value of 2.5 ppm (moderately t oxic). Table 21 summarizes the data that support the acute toxicity endpoi nts used in assessing the risks to aquatic

invertebrates. No triadimefon or triadimenol estuarine/marine invert ebrate acute toxicity tests were submitted to the Agency.

Table 21. Acute Toxicity Endpoints for Freshwater Invertebrates

Test Species/ Flow-through % a.i. 48-hr LC 50 (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 toxi city 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 a ssessing the risks to

freshwater invertebrates. No triadimenol freshwater invertebrate chroni c toxicity data was submitted, and no triadimefon or triadimenol estu arine/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 perf ormed for triadimefon on the technical formulated product on green algae, resulting in an EC 50 value of 1.71 ppm. The EC 50 value for triadimenol was 3.7 ppm. No studies were pe rformed on vascular aq uatic plant species.

Table 23 summarizes the data for the plant toxicity endpoints us ed in assessing the risks to aquatic plants.

Table 23. Toxicity Endpoints for Aquatic Plants (Nonvascular)

Species % a.i. EC 50 (ppm) EC 05 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 bot h the parent triadimefon as well as triadimenol for aquatic organisms. OPP gene rally 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 estimate d environmental concentrations (EECs) in surface water using labo ratory data that describe the rate at which the pesticide

breaks down and how it moves into the environm ent. The Pesticide Root Zone Model and Exposure Analysis Modeling Syst em (PRZM-EXAMS) model is in itially used to calculate high-end estimates of surface water concentrat ions of pesticide in a generic pond. This model was used to generate EECs of total tr iadimefon (parent + tr iadimenol) in surface

water. The User’s Manual and PRZM-EXAM S 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 concentratio ns above the active ingredient’s water solubility or at or a bove 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 con centrations (EECs) for triadimefon in surface water. Unlike the drinking water assessment de scribed in the human health risk assessment section of this document, the ecological water resource assessment does not include the Index43 Reservoir (IR) and Percent-Crop Area (PCA) fact or refinements. Th e IR and PCA factors represent a drinking water rese rvoir, not the variety of a quatic habitats, such as ponds adjacent to treated fields, relevant to a risk a ssessment for aquatic animals. The assumptions used represent pesticide transport in surface water in a standard pond (10,000-m 2 pond, 2-m deep), with the assumption that the small fiel d (10-ha agricultural fi eld) is cropped at 100%. Therefore, the EEC values used to assess expos ure to aquatic organisms are not the same as

the values used to assess human dietar y exposure from drinking water sources.

Several scenarios chosen to represent diffe rent U.S. regions and uses were modeled

for each use and can be found in the envir onmental fate and effects assessment for triadimefon. The turf scenarios gave the maxi mum EECs, and so were chosen for regulatory purposes. The EEC values used to assess expos ure 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

Acute Risk Quotients Chronic Risk Quotients Crop App. rate (# of apps., and

interval between apps.) Peak

EEC (ppb) Freshwate

r Fish

LC 50 =4100 ppb Freshwater

Invert.

LC 50 = 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 c oncern for non-target aquatic non-vascular plants. No toxicity data were available to as sess risks to non-target aquatic vascular plants.44 b. Terrestrial Organism Exposure and Risk

1) Bird and Mammal Toxicity

Birds

Triadimefon is classified as practical ly non-toxic to birds with acute oral LD 50 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, respec tively. With dietary LC 50 values between >4640 ppm to >10,000 ppm triadimefon is classified as practically non-toxic on a subacute dietary basis.

Avian single dose oral toxici ty studies were also perfor med on the major degradate triadimenol. The acute oral (LD 50 ) toxicity of triadi menol 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 (LC 50 >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 da ta that support the acute and subacute toxicity endpoints used in assessing the risks to bi rds 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 LD 50 = >2000 mg ai/kg bw MRID

41895901 Practically nontoxic Acute Toxicity

to Birds

Triadimenol Bobwhite quail LD 50 = >2000 mg ai/kg bw MRID

071469 Practically nontoxic

Triadimefon Bobwhite quail LC 50 = 8392

ppm MRID

00050066 Practically nontoxic Subacute Toxicity to Birds

Triadimenol Mallard duck LC 50 >5000

ppm MRID

00126277 Practically nontoxic

For chronic toxicity, avian re production 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 performe d for the degradate triadimenol with a NOAEL of 100 ppm ai (mallard duck). Table 26 su mmarizes 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/198245 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 LD 50 values of 1470 mg/kg (males) and 1090 mg/kg (fem ales). Acute toxicity tests showed LD 50 values of 689 mg/kg (males) and 752 mg/kg (females) for the degradate triadimenol, classifying it as slightly toxi c 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 LD 50 = 1090 mg/kg (females) MRID

00264276 Acceptable

Acute Toxicity

to Mammals Triadimen

ol Rat LD 50 = 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 F 1 and F 2 generations

and decreased litter size in the F 2 generation with an offspring NOAEL of 50 ppm ai. In addition, chronic toxicity tests for the degrad ate triadimenol showed decreased pup weights with a NOAEL of 100 ppm ai and a LOA EL of 500 ppm ai (see Table 28).

Table 28. Summary of Chronic T oxicity 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 0015124846 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 pesticid e residue in a given exposure scenario. Application methods for liquid triadimefon fo rmulations include ground spray, aerial spray, and chemigation. Additionally, granular triadimefon is broa dcast on residential lawns and turf (no soil incorporation).

The Agency assessed exposure to terrestria l 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 ma mmals to determine the amount of pesticide consumed. Estimated exposure concentrations fo r terrestrial animals (via spray applications) were determined by using the standard scr eening-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 c ourse use rates and application intervals were used (2 applications @ 2.7 lbs. ai/A).

For a single application there is a linear relationship betw een the amount of pesticide applied and the amount of pesticide resi due present on a given food item. These relationships for the various food items are dete rmined from the Kenaga nomogram, which is a model developed by Hoerger and Kenaga (19 72) and modified by Fletcher (1994). In addition to incorporating the nomogram re lationship, 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 applicati ons of 2.7 lbs. ai/A at 14 day in tervals 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 LD 50 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 Ch ronic RQs for turf uses of Triadimefon (based on NOAEC of 20 mg/kg die t) 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 mammalia n acute LOC exceedances (LOC > 0.5) for small and medium (15 and 35g) mammals wh ich consume short grass treated with 2 applications @ 2.7 lbs. ai/A with a 14-day interval. Endange red 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 valu es resulting from residential application
at a rate of 2.7 lbs. ai/A (2 appl ications, 14-day inte rval) is 28.12 mg/ft 2 (See Table 30).

Table 30. Mammalian Dose-based Acute RQs for turf uses of Triadimefon (based on

Triadimenol LD 50 of 689 mg/kg in rats) ba sed on upper-bound Kenaga values

. Spray Application

Mammalian Dose-based Acute Risk Quotients Use Body Weight (g) Adjusted

LD 50 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 LD 50 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 RQ s for selected uses of non-granular Triadimefon (based on tr iadimefon rat NOAEL of 50m g/kg diet) and upper-bound Kenaga values.

Dietary-based Chronic Risk Quotients Use

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 fug acity-based (equilibrium pa rtitioning) approach, an

estimation of the concentration of triadime fon and its degradates in earthworms were calculated in order to determine the possible c ontribution of earthworm (and other terrestrial invertebrate) consumption to mammal and avia n risk. The calculated earthworm tissue concentrations of triadimefon/triadimenol sugge st that ingestion of earthworms by birds and mammals based on dietary dose (triadimef on NOAEC = 20 mg/kg diet and NOAEL = 2.5 mg/kg bw, respectively) could be another e xposure pathway contribu ting to chronic risk, although the low earthworm concentrations would necessitate consumpti on of a large number

of worms.

4) Non-target Terrestrial Plants

Non-target Terrestrial Plants

No guideline studies evaluating the toxicity of triadimefon to terr estrial plants have been submitted to the Agency. However, althou gh several other studies within the Agency’s

database were not suitable for use in determini ng toxicity endpoints, th ey 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 th at triadimefon may have negative effects on both monocot and dicot non-target terr estrial 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 LD 50 for triadimefon is >25 u g 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 i nvolving 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 freshwat er aquatic invertebrates. However, the assessment indicates that triadimefon has the po tential for causing risk to endangered birds, mammals, and non-target plants. Further, poten tial 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 EP A’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 Ag ency to determine, after submission of relevant data concerning an active ingredient , whether or not products containing the active ingredient are eligible for rere gistration. The Agency has prev iously identified and required the submission of the generic (i.e., active i ngredient-specific) data required to support reregistration of products cont aining 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 produc ts containing triadimefon.

The Agency has completed its assessment of the dietary, occupati onal, 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 FI FRA, as amended by FQPA. The Agency has determined that products containing triadi mefon are eligible for reregistration provided that: (i) required product-specific data are submit ted; (ii) risk mitigation measures outlined in this document are adopted (including requests fo r deletion of certain uses); and (iii) label50 amendments are made to reflect these measures. Label changes are described in Section V. Appendix A summarizes the uses of triadimef on that are eligible for reregistration. Appendix B identifies the generic data requirement s 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 documen t, the Agency may take regulatory action to

address the risk concerns from the use of tr iadimefon. 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, furt her changes to these registrations may be necessary, as explained in Section IV..D..4 of th is 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 acti on 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 metabolite s, the Agency has determined that the

tolerances for triadimefon and triadimenol ar e 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 regulat ory decisions for triadimefon. EPA released its preliminary risk assessments for triadi mefon and triadimenol for public comment on February 16, 2006, for a 60-day public comment pe riod (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, nurse ry and forestry cooperatives, the U.S. Triazole Task Force, a nd the technical registra nt 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 (E PA-HQ-OPP-2006-0038) in the EP A’s electronic docket at http://www.regulations.gov

.

C. Regulatory Position under the FFDCA

1. Food Quality Protection Act Findings

a. “Risk Cup” Determination51 As part of the FQPA tolerance reasse ssment process, EPA assessed the risks associated with this pesticide. The Agency ha s 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 triadime fon and triadimenol will meet FQPA safety standards. In reaching this determination, EPA has considered the available information on the special sensitivity of infants and childre n, as well as exposure s to triadimefon and triadimenol from all possible sources. Furtherm ore, if the registrant does not cancel the uses agreed to or make the mitiga tion 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 tria dimenol. In reaching this conclusion, the Agency has considered all available informati on 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 aggregat e risks from triadimefon and triadimenol from food, drinking water, a nd residential exposure are not of concern, provided the mitigation measures described in this document are implemented through amendments to existing registrations. Furthermore, aggregat e 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 re gistered uses of all triazole fungicides.

c. Determination of Safety to Infants and Children

EPA has determined that the established to lerances 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 al so takes into account the possibility of increased dietary exposure due to the specific consumption pa tterns of infants and children, as well as the possibility of in creased susceptibility to the t oxic effects of triadimefon and

triadimenol residues in this population subgroup.

d. Endocrine Disruptor Effects

EPA is required under the FFDCA, as ame nded by FQPA, to develop a screening program to determine whether certain substanc es (including all pes ticide active and other ingredients) “may have an eff ect in humans that is similar to an effect produced by a52 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 evaluati ons. As the science de velops 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 require s that, when considering whether to establish, modify, or revoke a tolerance, th e Agency consider “available information” concerning the cumulative effects of a particular pesticide’s residues a nd “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 th e 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 triadimef on 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 chemi cal classes. For information regarding EPA’s efforts to

determine which chemicals have a common mech anism 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 mechan ism 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 plan t 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 re sidues 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 pare nt compound) in/on various plant and animal commodities [40 CFR §180.410]. The established to lerances 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 metabol ites in/on raspberrie s at 2.0 ppm [40 CFR53 §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 wher e tolerances are establishe d for residues of both 1-(4- chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazo le-1-yl)-2-butanone (triadimefon) and β -(4- chlorophenoxy)- α -(1,1-dimethylethyl)-1H-1,2,4-triazole-1-eth anol (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 th e same raw agricultural commodity and its products thereof, the total amount of such resi dues 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) shoul d be deleted. A tolerance summary for triadimefon is presented in Table 32.

Table 32. Tolerance Su mmary 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 to54 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 (Code x) has established several MRLs for triadimenol in/on various raw agricultural comm odities. 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 an d/or triadimenol. Compatibility cannot be

achieved with the Codex MRLs because these le vels 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 co tton and triadimenol and KWG 1342 in/on

bananas..

c. Residue Analytical Methods – Plants/Livestock

The reregistration requirements for residue an alytical methods are fulfilled. Adequate

methods are available for data collection and for the enforcement of tole rances for residues of

triadimefon per se in/on plant commodities. Since ther e is no reasonable expectation of residues in poultry, enforcement methods for th e determination of tr iadimefon residues in

livestock commodities are not needed.

Plant Commodities

. Two methods of gas chromatography with mass spectrometry detection (GC/MS) are listed in the Pestic ide 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 conve rted to p-dichlorophenol, derivatized with dinitrofluorobenzene, and reported as triadi mefon equivalents. The GC/MS method is no56 longer adequate due to the recommended tolera nce expression revisions. However, a GC method using a nitrogen phosphor us 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 pineappl e 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 livesto ck commodities. Met hod I (Report No. 69531) is appropriate for livestock ti ssues and milk and Method II (R eport 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 tria dimefon is completely recove red (>80%) using Multiresidue Methods Section 302 (Luke Method ; Protocol D); recovery of triadimefon is small (<50%) using Multiresidue Methods Sections 303 (Mil ls, 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 residue s of triadimenol resulting from direct application to primary crops is adequate. Th e Agency has determined that the tolerance expression for residues in/on cer eal 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-tri azol-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 es tablished for residues of triadimenol and its metabolites containing the chlorophenoxy moiety (calculated as triadi menol) 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 barle y, 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), a nd 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 th e 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 reques ted corn and wheat metabolism studies. If, however, foliar uses or registration on additi onal major livestock feed items are requested, then triazole and phenyl-labeled livestock meta bolism 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 Un der 40 CFR §180.450(a)

Banana (Whole) 1 0.2 0.2

Barley, grain 0.05 TBD 2

Barley, straw 0.2 TBD 2

Corn, forage 0.05 TBD 2 [Corn, field, forage]

[Corn, sweet, forage]

Corn, fresh (including sweet), (K+CWHR) 0.05 TBD 2 [Corn, sweet, K+CWHR]

Corn, grain 0.05 TBD 2 [Corn, field, grain]

[Corn, pop, grain]

Corn, stover 0.05 TBD 2 [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 TBD 2

Oat, grain 0.05 TBD 2

Oat, forage 2.5 TBD 2

Oat, straw 0.2 TBD 2

Rye, forage 2.5 TBD 2

Rye, grain 0.05 TBD 2

Rye, straw 0.1 TBD 258 Commodity Current Tolerance (ppm) Tolerance Reassessment (ppm) Comment/

[Correct Commodity Definition]

Tolerances Established Un der 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 TBD 2

Wheat, grain 0.05 TBD 2

Wheat, straw 0.2 TBD 2

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 TBD 2

Cotton, gin byproducts None established TBD 2

Oat, hay None established TBD 2

Wheat, hay None established TBD 2

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 tolera nces and EPA considers them reassessed.

D. Regulatory Rationale under FIFRA59 The Agency has determined that triadime fon is eligible fo r reregistration, in compliance with FIFRA, and the associated to lerances are considered reassessed, provided that: 1) required product-specific and generic data are submitted; 2) risk mitigation measures (including requests to delete certa in uses) outlined in this docu ment 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 w ith the uses that are being deleted.

Risks for currently registered uses of tr iadimenol 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 labe ling revisions are required, specif ic 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 de lete 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 re sidential 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 ma ximum single application rate of 2.7 lbs ai/A, and a maximum yearly rate of 5.4 lbs ai/A. W ith 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 flower s, shrubs, and trees;

• Greenhouse ornamental flower s, shrubs, and trees.

Bayer, the sole technical registrant, has ag reed to request volunt ary deletions of the

residential turf use to address post-application and aggregate ri sks to toddlers. In addition, a 17-day post-application, pre-harvest interval is required for sod fa rm turf, to address potential risks to toddlers exposed to sod farm tu rf transplanted to a residential setting.

In order to address risks to residential handlers making a pplications to ornamentals, the following mitigation measures are required:

• Package all wettable powder pr oducts in water-soluble bags;

• Prohibit application with hose-end sprayers in residential greenhouses;60 • Reduce the application rate fo r all outdoor ornamental appl ications to a maximum of 0.0025 lbs ai/gallon (for certa in use sites, rates will remain lower than this maximum).

Currently, the number of applic ations that can be made to golf course turf is not specified on product labels. Golf course us e will be restricted to a maximum single application rate of 2.7 lbs ai/A, and a maxi mum 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 flow ers, 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 c ourse and sod farm turf be volun tarily deleted, reducing handler exposure. For golf courses and sod farms, a ma ximum single application rate of 2.7 lbs ai/A, and a maximum yearly rate of 5.4 lbs ai/A ar e required, further reduci ng 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 occupatio nal 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 o ccupational handlers performing the following

activities:

• Mixing and loading all formulations (liq uids, wettable powders, dry flowables)

• Loading granulars;61 • Making applications with handheld equipment;

• Any activities which involve contact with treated seed (inc luding drying, raking, bagging, and sewing bags);

• Mixing, loading, and applying when using a tree-injection unit;

• Applying a ready-to-use bri quette to pine seedlings.

(4) Require both chemical resi stant gloves and a chemical resistant apron for occupational handlers performing the following activities:

• Dipping pineapples (pre-pla nt, 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 acu te and chronic dietar y risks from food and drinking water as well as resi dential handler and post-applica tion exposures in the aggregate

risk assessment for the free triazoles. Therefor e, no further mitigation is necessary at this

time.

2. Environmental Risk Mitigation

A number of the mitigation measures desc ribed 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 ra te 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 tu rf (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 a ll end-use products containing tr iadimefon. For the specific labeling statements and a list of outstanding data , refer to Section V of this RED document.

4. Endangered Species Program62 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 freshwat er aquatic invertebrates. However, the assessment indicates that triadimefon has the po tential for causing acute risk to endangered birds, mammals, and non-vascular aquatic pl ants. Chronic RQs for endangered mammals

exceed the level of concern at all application rates modele d. 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 pr ecluded 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 impact s 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 acti ons are not likely to je opardize listed species or adversely modify designated critical habitat. To analy ze 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 eco logical parameters, pesticide use information, geographic relationship between specific pestic ide uses and species locations, and biological requirements and behavioral aspects of the particul ar species. This analysis will consider the risk mitigation measures that are being implem ented 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 specie s or its critical hab itat 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 empl oy 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 like lihood that endangered and threatened species may be exposed to tria dimefon 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 th em 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 risk s or adverse effects to humans or the environment provided that the risk mitigati on measures and label changes (including use63 deletions) outlined in this document are implemented. Therefore, all remaining uses of these products are eligible for reregistration. These products will be reregi stered once the required confirmatory generic data, product specific data , CSFs, and revised labeling are received and accepted by EPA. Products that contain other in gredients in addition to triadimefon will be reregistered when all of their other ac tive 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 regi strant’s response form); and 2. Any time extension and/or waiv er requests with a full written justification.

Within the time limit speci fied in the generic DCI:

1. Citations of any existing generic da ta 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) Do cument 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 th e active ingredient triadimefon , the registrant needs to submit the following items for each product:

Within 90 days from the receipt of th e product-specific data call-in (PDCI):

(1) completed response forms to the PDCI (i.e., PDCI response form and requirements status and regist rant’s response form); and

(2) any time extension or waiver reque sts with a full written justification.

Within eight months from the receipt of the PDCI:

(1) two copies of the confidential st atement of formula (EPA Form 8570-4);64 (2) a completed original application fo r reregistration (EPA Form 8570-1). Indicate on the form that it is an “application for reregistration”;

(3) five copies of the draft label, incor porating 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 certif ying 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 material s 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 reregi stration 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 Neurot oxicity 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 A65 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, ma nufacturing-use product (MUP) labeling should be revised to comply with all current EPA regulations, PR Notices, and applicable policies. The MUP labeling shoul d bear the labeling contained in the labeling table, which will be issued separately.

B. End-Use Products

1. Additional Product-Sp ecific Data Requirements

Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed productspecific data regarding th e pesticide after a determination of eligibility has been made. The Registrant must review previ ous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit to conduct new studies. If a regi strant believes that previously submitted data meet current tes ting 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 requi rements, 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 thes e changes is specified in Table 34.

C. Data Requirements for Triadimenol

There are data that must be submitted to support the conti nuing registration of

triadimenol. These data are not expected to change the regulat ory conclusions for triadimenol described in this document. A generic DCI w ill be issued and will require development and

submission of these listed data in order to conf irm the conclusions outlined in this document.

Product Chemistry Guideline Study Name New OPPTS

Guideline No. Old Guideline No.

Stability 830.6313 63-13 pH ( H 2 0 solutions) 830.7000 63-12 Ultraviolet/visible Absorption 830.7050 None

Partition Coefficient (N-octanol/water) 830.7550

830.7560

OR 63-1166 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 comm odities 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 residu es of triadimenol, KWG 1342, and KWG 1732 in/on field corn (forage, grai n, stover), sweet corn (forage, kernel plus cob with husks removed, grain, and stover), cotton (undelin ted 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 tr iadimenol 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 reques ted metabolism studies.

D. Labeling Changes Summary Table

For triadimefon to be eligible for reregi stration, 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.67Table 34. Labeling Changes Summary TableSummary of Labeling Changes for TriadimefonDescriptionAmended Labeling LanguagePlacement on LabelManufacturing Use ProductsOnly for formulation into afungicidefor 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 seeds,and pineapple (preplant dip and postharvest dip only), ““This product can not be formulated into end-use products with directions for use in residential orcommercial settings on apples, grapes, pears, raspberries, azaleas (except to control pine-twisting rustonly), 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 onazaleas, pine seedlings, pine seeds, or pineapple.”“This product can not be formulated into dry flowable end-use products with directions for use on pinetrees, pine seedlings, or pineapple.”“This product can be formulated into granular end-use products with directions for use only on golfcourse turfgrass or sodfarm turfgrass.”Directions for UseOne of these statements maybe added to a label to allowreformulation of the productfor a specific use or alladditional uses supported bya formulator or user group“This product may be used to formulate products for specific use(s) not listed on the MP label if theformulator, user group, or grower has complied with U.S. EPA submission requirements regardingsupport of such use(s).”Directions for UseEnvironmental Hazards“Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or otherwaters unless in accordance with the requirements ofa National Pollutant Discharge Elimination System(NPDES) permit and the permitting authority has beennotified in writing prior to discharge. Do notdischarge effluent containing this product to sewer systems without previously notifying the local sewagetreatment plant authority. For guidance, contact your State Water Board or Regional Office of the EPA.”Precautionary Statementsimmediately following theUser SafetyRecommendations68End Use Products Intended for Occupational Use (WPS and NonWPS)PPE RequirementsEstablished by the RED1forliquid concentrate end-useproducts“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 insertsA,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)whenmixing/loading or when applying using handheld equipment or handheld nozzles.”“See engineering controls for additional requirements.”Immediatelyfollowing/belowPrecautionary Statements:Hazards to Humans andDomestic AnimalsPPE RequirementsEstablished by the RED1fordry flowable end-useproductsNote: if the end-use productdoes not have directions foruse as a seed treatment, thenthe phrase “or when handlingtreated seed (includingspreading, drying, raking,bagging, and sewing seedbags)” 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 insertsA,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)whenmixing/loading, when applying using handheld equipment or handheld nozzles, or when handling treatedseed (including spreading, drying, raking, bagging, and sewing seed bags).”“See engineering controls for additional requirements.”Immediatelyfollowing/belowPrecautionary Statements:Hazards to Humans andDomestic AnimalsPPE RequirementsEstablished by the RED1forwettable powder end-useproducts“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 insertsA,B,C,D,E,F,G,or H]Aon an EPA chemical-resistance category selection chart.”Immediatelyfollowing/belowPrecautionary Statements:Hazards to Humans andDomestic Animals69End Use Products Intended for Occupational Use (WPS and NonWPS)Note: all wettable powderproducts must be in watersoluble packets to be eligiblefor reregistration.Note: if the end-use productdoes not have directions foruse as a seed treatment, thenthe phrase “or when handlingtreated seed (includingspreading, drying, raking,bagging, and sewing seedbags)” may be dropped.Note: if the end-use productdoes not have directions foruse as a dip treatment, thenthe phrases “participating indip applications” may bedropped.“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)whenmixing/loading, when using handheld equipment or handheld nozzles, when participating in dipapplications, or when handling treated seed (including spreading, drying, raking, bagging, and sewingseed bags), and> Chemical-resistant apron, when mixing/loading, when participating in dip applications, or cleaningspills or equipment.”“See engineering controls for additional requirements.”PPE RequirementsEstablished by the RED1forgranular 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 insertsA,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)whenloading.”“See engineering controls for additional requirements.”Immediatelyfollowing/belowPrecautionary Statements:Hazards to Humans andDomestic Animals70End Use Products Intended for Occupational Use (WPS and NonWPS)PPE RequirementsEstablished by the RED1forready-to-use briquetteproducts“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 insertsA,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). “Immediatelyfollowing/belowPrecautionary Statements:Hazards to Humans andDomestic AnimalsPPE RequirementsEstablished by the RED1fortree-injection productsNote: if the tree-injectionproduct is ready-to-use, thewords “mixers, loaders” maybe 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 insertsA,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection chart.”“Mixers, loaders, applicatorsand 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).”Immediatelyfollowing/belowPrecautionary Statements:Hazards to Humans andDomestic AnimalsUser Safety Requirements“Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washablesexist, 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 withthis product’s concentrate. Do not reuse them.”Precautionary Statements:Hazards to Humans andDomestic Animalsimmediately following thePPE requirements71End Use Products Intended for Occupational Use (WPS and NonWPS)Engineering Controls forliquid, dry flowable , orgranular formulations thatcontain directions for use forsodfarm turfgrass“Engineering Controls”“Pilots must use an enclosed cockpit in a manner that is consistent with the WPS for AgriculturalPesticides [40 CFR170.240(d)(6)]. Pilots must wearthe PPE required on this labeling for applicators.”Precautionary Statements:Hazards to Humans andDomestic Animals(Immediately followingPPE and User SafetyRequirements.)Engineering Controls forwettable powders packagedin water-soluble packets.Allwettable powders must be inwater soluble packets to beeligible for reregistration.“Engineering Controls”“Water soluble packets when used correctly qualify asa closed mixing/loading system under the WorkerProtection Standard for Agricultural Pesticides [40 CFR 170.240(d)(4). Mixers and loaders using watersoluble packets must:-wear the personal protective equipment requiredon this labeling for mixers and loaders, and-be provided, have immediately available, and wear inan emergency, such as a broken package, spill, orequipment breakdown:>chemical resistant footwear and>a NIOSH-approved respirator equipped with:-- a dust/mist filter withMSHA/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 AgriculturalPesticides [40 CFR170.240(d)(6)]. Pilots must wearthe PPE required on this labeling for applicators.”Precautionary Statements:Hazards to Humans andDomestic Animals(Immediately followingPPE and User SafetyRequirements.)User SafetyRecommendations“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 puton clean clothing.”“Users should remove PPE immediately after handling this product. Wash the outside of gloves beforeremoving. As soon as possible, wash thoroughly and change into clean clothing.”Precautionary Statementsunder: Hazards to Humansand Domestic Animalsimmediately followingEngineering Controls(Must be placed in a box.)72End Use Products Intended for Occupational Use (WPS and NonWPS)Environmental Hazards“ ENVIRONMENTAL HAZARDS”“Do not apply directly to water, orto areas where surface water is present or to intertidal areas below themean water mark. Do not contaminate water whendisposing of equipment washwater or rinsate.”“Do not apply when weather conditions favor drift from treated areas. Drift and runoff from treated areasmay be hazardous to organisms in neighboring areas.”“This product may contaminate water through runoff. This product has a high potential for runoff forseveral months or more after application. Poorly draining soils and soils with shallow water tables aremore prone to produce runoff that contains this product.”“This chemical has properties and characteristics associated with chemicals detected in ground water. Theuse of this chemical in areas where soils are permeable, particularly where the water table is shallow, mayresult in ground water contamination.”Environmental HazardsRestricted-Entry Interval (forlabels with WPS uses)Note: the prohibition forsodfarms may be dropped ifthe end-use product does notcontain directions for use onsodfarms“Do not enter or allow worker entryinto treated areas during the restricted entry interval (REI) of 12hours.”“Harvesting or transplanting turfgrass grown on sodfarms is prohibited for 17 days followingapplication.”Directions for Use,Agricultural UseRequirements BoxEarly Reentry PersonalProtective Equipmentestablished by the RED (forlabels with WPS uses)“PPE required for early entry to treated areas that is permitted underthe Worker Protection Standard andthat involves contact with anything that has beentreated, such as plants, soil, or water, is:> coveralls,> shoes plus socks, and> chemical-resistant gloves madeof any waterproof material.”Place in the Directions forUse In Agricultural UseRequirements box,immediately following theREIEntry Restriction forNonWPS usesEntry Restriction for non-WPSuses applied as a spray (does not include tree-injection uses):“Do not enter or allow others to enter until sprays have dried.”If no WPS uses on thelabel, place the statementsin the Directions for UseUnder General Precautions73End 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 treatedarea (except those involved in watering-in) untilwatering-in is complete and the surface is dry.”and Restrictions.If WPS uses are also onthe labeling, place thesestatements in aNonAgricultural UseRequirements box asspecified in PR Notice 93-7 and 93-11.General ApplicationRestrictions (for labels withWPS uses)“Do not apply this product in a way that will contactworkers or other persons, either directly or throughdrift. Only protected handlers may be in the area during application.”Place in the Directions forUse directly above theAgricultural Use Box.Other ApplicationRestrictions (RiskMitigation)All Products/Formulations Containing TriadimefonDelete 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. Applicationsare permitted on nonbearing fruit or nut trees only.”Directions for UseSpray Drift“Spray drift requirements”(1) For groundbloom and aerial applications, use only medium or coarser spray nozzles according toASABE (S572) definition for standard nozzles. Aerial applicators must consider flight speed and nozzleorientation in determining droplet size.74End 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 thewind speed is greater than 10 mph.For all non-aerial applications, windspeed must be measured adjacentto 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 cropcanopy.(6) For airblast applications, turn off outward pointing nozzles at row ends and when spraying the outertwo rows. To minimize spray loss over the top in tree applications, spray must be directed into thecanopy.(7) For aerial applications, do not release spray at a height greater than 10 feetabove the ground or plantcanopy.(8) For aerial applications, the outermost nozzles must not exceed 60% of the wingspan or 80% of therotor blade diameter.(9) When aerial applications are made with a cross-wind, the swath will bedisplaced downwind. Theapplicator must compensate for this displacement at the downwindedge of the application area byadjusting the path of the aircraft upwind.”Application Restrictions forTurfgrass Uses(Note: The maximumallowable application rateper application or per yearmust be listed as pounds orgallons of formulatedproduct per acre, not solelyas pounds active ingredientper acre.)“Use on turfgrass is limited to sodfarm turf and golfcourse turf only. Use on turfgrass is prohibited onall other residential and commercial sites.”Maximum application rate is 2.7 lb ai/AMaximum annual application rate is 5.4 lb ai/AMinimum retreatment interval is 14 days.“Aerial application and chemigation to turfare permitted on sodfarm turfgrass only.”“Application to golf courses, including tees, greens, fairways, and roughs, is permitted only if theturfgrass is 2.5 inches or less in height.”Directions for Useassociated with turfgrassuse directions75End Use Products Intended for Occupational Use (WPS and NonWPS)“Harvesting or transplanting turfgrass grown on sodfarms is prohibited for 17 days followingapplication.”Application Restrictions forAzaleas“Use on azaleas is limited to applicationsto control pine-twisting rust disease.”Directions for Useassociated with azalea usedirectionsApplication Restrictions forOrnamentals and Pine Trees,including Christmas trees“Chemigation is permitted for use on ornamentals and pine trees, including Christmas trees.”Application Restrictions forOrnamentals at ResidentialSitesNote: The maximumallowable application ratemust be listed as pounds orgallons of formulatedproduct per acre, not solelyas pounds active ingredientper gallon.)“The maximum application rate forornamentals (including azaleas) atresidential sites is 0.0025 lbai/gal.”Directions for Useassociated with ornamentaluse directionsEnd Use Products Intended Primarily for Use by HomeownersEnvironmental Hazards“ ENVIRONMENTAL HAZARDS”“Do not apply directly to water. Do not contaminate water when disposing of equipment washwaters orrinsate.”“Do not apply when weather conditions favor drift from treated areas. Drift and runoff from treated areasmay be hazardous to organisms in neighboring areas.”“This product may contaminate water through runoff. This product has a high potential for runoff forPrecautionary Statements76End Use Products Intended for Occupational Use (WPS and NonWPS)several months or more after application. Poorly draining soils and soils with shallow water tables aremore prone to produce runoff that contains this product.”“This chemical has properties and characteristics associated with chemicals detected in ground water. Theuse of this chemical in areas where soils are permeable, particularly where the water table is shallow, mayresult in ground water contamination.”Application RestrictionsAll products:“Do not apply this product in a way that will contact anyperson or pet, either directly or through drift.Keep people and pets out ofthe area during application.”Directions for Use underGeneral Precautions andRestrictionsStatements must be in thecolor red and in all caps.Entry RestrictionsProducts 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 underGeneral Precautions andRestrictionsDirections for Use“Do not apply this product to lawns or other turfgrass.”Directions for Use sectionDirections for Use onOrnamentalsNote: The maximumallowable application ratemust be listed as pounds orgallons of formulatedproduct per acre, not solelyas pounds active ingredientper 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.”Directions for Use sectionassociated with thedirections for ornamentalusesOther ApplicationRestrictions (RiskMitigation)All Products/Formulations Containing TriadimefonDelete all directions for use for the following use-patterns:Directions for Use77End Use Products Intended for Occupational Use (WPS and NonWPS)> apples> grapes> pears> raspberries> residential or commercial turfgrassInclude the following statement: “Application to trees that bear fruit or nuts is prohibited. Applicationsare permitted on nonbearing fruit or nut trees only.”1PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE inthis document. The moreprotective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice93-7.2The registrant must drop the N type filter from the respiratorstatement if the pesticide product contains or is used with oil.Instructions in the Labelingsection appearing in quotations represent the exactlanguage that should appear on the label.Instructions in the Labelingsection not in quotes represents actions that the registrantshould take to amend their labels or product registrations.78 

## VI. Appendices79Appendix A: Use Patterns Subject toReregistrationfor TriadimefonSiteApplication TypeApplication TimingApplication EquipmentFormulationMax. SingleApplication Rate(ai)Max. #Apps.MinimumRetreatmentInterval (Days)Use Limitations(Food Uses)Pineapples(post-harvest or pre-plant crowns)Pre-plant and Post-harvest dip,sprayWP0.0028 lbs ai/gallon 1 Not Required;since only oneapplication.(NR)All wettable powder products must be packaged in watersoluble bags.(Non-food Uses)Azaleas(for control of pine twisting rust, onlyChemigation, groundboom, lowpressure handwand, high pressurehandwandWPDF0.005 lbs ai/gallon 8 14All wettable powder products must be packaged in watersoluble bags.Christmas treesAerial, flagging, airblastWP0.25 lbs ai/A 8 14A closed cockpit is required for aerial applications (allformulations).All wettable powder products must be packaged in watersoluble bags.Golf Course Turf80SiteApplication TypeApplication TimingApplication EquipmentFormulationMax. SingleApplication Rate(ai)Max. #Apps.MinimumRetreatmentInterval (Days)Use LimitationsGroundboom, LCO handgun, lowpressure handwand, and handgunsprayerFlagging, tractor-drawn spreaderLCWPDFG2.7 lbs ai/A2(at max.single app.rate)14Use is restricted to golf course and sod farm turf, only.A maximum annual application rate of 5.4 lbs ai/A isallowed.Applications are restricted to turf less than 2.5 inches inheight. This applies to the entire golf course, includingtees, greens, fairways, and roughs.All wettable powder products must be packaged in watersoluble bags.Greenhouse Ornamentals(including flowers, shrubs, and trees)Low-pressure handwand, handgunsprayer, high-pressure handwandWPLC0.00625 lbs ai/gallon0.00938 lbs ai/gallon81414Prohibit residential (consumer) hose-end sprayerapplicationsin greenhouses.All wettable powder products must be packaged in watersoluble bags.Ornamentals(including flowers, shrubs and trees)Low-pressure handwand, handgunsprayer, high-pressure handwandLow-pressure handwand,chemigation, groundboom, highpressure handwandLCWPDF0.0023 lbs ai/gallon0.0025 lbs ai/gallon81414Residential (consumer) use limited to ornamentals, only.Professional hose-end sprayerapplications are allowed.All wettable powder products must be packaged in watersoluble bags.Ornamentals(including shade trees and woody shrubs)81SiteApplication TypeApplication TimingApplication EquipmentFormulationMax. SingleApplication Rate(ai)Max. #Apps.MinimumRetreatmentInterval (Days)Use LimitationsTree injection unit (ready-to-usemicro injection unit, or unitrequiring product dilution)LC0.000026 lbs ai/ inch oftrunk circumference6 NSPines(including Christmas trees)Low-pressure handwand andhandgun sprayerLC0.0023 lbs ai/gallon 8 14Pine Seed(on-nursery applications)DipPlanter box, hopper box, cementmixer,Cement mixerWPWPDF0.0000625 lbs ai/gallon0.0013 lbs ai/A0.00136 lbs ai/A111NRNRNRAll wettable powder products must be packaged in watersoluble bags.Pine Seed(commercial applications)Commercial loading/applying,commercial bagging of treatedseed, commercial bag sewing, andmultiple commercial activitiesWP0.0013 lbs ai/lb 1 NRAll wettable powder products must be packaged in watersoluble bags.Pine SeedlingsAerial, flagging, airblast,groundboom, low-pressurehandwand, handgun sprayerBy handWPReady-to-usebriquette0.5 lbs ai/A0.000019 lbs ai/seedling41NRNRA closed cockpit is required for aerial application.All wettable powder products must be packaged in watersoluble bags.Roses82SiteApplication TypeApplication TimingApplication EquipmentFormulationMax. SingleApplication Rate(ai)Max. #Apps.MinimumRetreatmentInterval (Days)Use LimitationsLow-pressure handwand, handgunsprayer, high-pressure handwandLCWP0.00029 lbs ai/gallon 8 14All wettable powder products must be packaged in watersoluble bags.Sod Farm TurfAerial, chemigation, flagging,groundboom, LCO handgun, lowpressure handwand, and handgunsprayerAerial, flagging, tractor-drawnspreaderWPDFG2.7 lbs ai/A2(at max.single app.rate)17A closed cockpit is required for aerial applications (allformulations).A maximum annual application rate of 5.4 lbs ai/A isallowed.All wettable powder products must be packaged in watersoluble bags.83 Appendix B. Table of Generic Data Requi rements and Studies Used to Make the Reregistration Decision

GUIDE TO APPENDIX B

Appendix B contains listing of data requi rements 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/tria dimenol in all produc ts, 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 require ments are listed in the order in which they appear in 40 CFR part 158. The reference numbers accompanying each test refer to the te st protocols set in the Pesticide Assessment Guidance, which are avai lable from the National technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)

487-4650.

2. Use Pattern (Column 2). This column indica tes 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. Re fer to the Bibliography appendix for a complete citation of the study.84 

# APPENDIX B-1

Data Supporting Guideline Requirements fo r 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 4161600185 Data Supporting Guideline Requirements fo r 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, 4192210386 Data Supporting Guideline Requirements fo r 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,

9218801887 Data Supporting Guideline Requirements fo r 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 inthe 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 inthe 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 4565450388 Data Supporting Guideline Requirements fo r 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 Leachin g/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 Bioaccu mulation in Fish 41619901

None 165-5 Bioaccumulati on- 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 CHEMISTRY89 Data Supporting Guideline Requirements fo r 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/A90 

# APPENDIX B-2

Data Supporting Guideline Requirements fo r 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/A91 Data Supporting Guideline Requirements fo r 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,

4236500192 Data Supporting Guideline Requirements fo r 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,

4370540193 Data Supporting Guideline Requirements fo r 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/A94 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 Sout h 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, Proba bilistic 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 Ac ute, Chronic, and Short-Term Risk Assessments Reflecting July, 2006 Risk Mi tigation in Response to the Phase 4

Triadimefon RED.

5. DP Barcode D328262. Rich Griffi n. 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 Reside ntial Exposure Assessment for the Reregistration Eligibil ity 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 Fungicid es and Anastrozole, a Drug.

9. Sam Ary. Triadimefon. Acute and Ch ronic Dietary Exposure Assessments for the Reregistration Eligibility Decision (RED) Document.95 10. DP Barcode D321636. Sam Ary. Augus t 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. Nove mber 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. N ovember 18, 2005. Triadimenol Acute and Chronic Dietary Exposure Assessments for the Tolerance Reassessment Eligibility Decision Document.

16. DP Barcode D314891. Sam Ary. N ovember 17, 2005. Triadimenol. Summary of Analytical Chemistry a nd 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 A ssessments to Support Reregistration and Registration Actions for Tr iazole-derivative Fungicides.96 22. DP Barcode D322239. Michael Dohe rty. December 20, 2005. Triazole

Alanine and Triazole Acetic Acid. Acute and Chronic Dietary Exposure Assessments to Support Reregistration a nd Registration Actions for Triazolederivative Fungicides.

23. DP Barcode D322215. Michael Dohert y. 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- 2 nd Report of the Ad Hoc HED Peer Review

Committee.

Ecological Fate and Effects Documents:

1. DP Barcode D328531. Fred Jenkins a nd Jonathan Angier. June 1, 2006. Response to Bayer Public Comments Re garding 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 Reregistra tion 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 alanin e (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 (Bibli ography) for Triadimefon and Triadimenol



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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

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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.

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41976602 Williams, B.; Conrath, B. (1991) Triadimefon/Triadimeno l 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.

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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.

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42153901 Bomhard, E.; Schilde, B. (1991) MEB 6447: Chronic Toxicity and Cancerogenicity Studies

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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 Tria dimefon in California Soils: Revised: Lab Project Number: 100150: BL830089R0A: 892010.1-1K. Unpublished study prepared by Plant Science, Inc., Siemer and Associ ates, 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 Re peated 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: BL741 701. Unpublished study prepared by Miles, Inc. 106 p.

42342303 Burger, R. (1992) Triadimefon (50DF)--Magnitude of the Residue on Apples: Lab Project Number: BL 19AP01: 39590: 102625. Unpublished study prepared by Miles, Inc. and ABC Laboratories. 386 p.

42342304 Burger, R. (1992) Triadimefon (50DF)--Magnitude of the Residue on Cantaloupe: Lab Project Number: BL 19CP01: 39585: 102628. Unpublished study prepared by Miles, Inc. and ABC Laboratories. 319 p.

42342305 Burger, R. (1992) Triadimefon (50DF)--Magnitude of the Residue on Cucumber: Lab Project Number: BL 19CU01: 39586: 102630. Unpublished study prepared by Miles, Inc. and ABC Laboratories. 409 p.

42342306 Burger, R. (1992) Triadimefon (50DF)--Magnitude of the Residue on Pears: Lab Project Number: BL 19PR01: 39592: 102626. Unpublished study prepared by Miles, Inc. and ABC Laboratories. 303 p.

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 Laboratories, and Dole Packaged Foods Co. 416 p.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. (1 992) 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.

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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 Developmen t 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 Developmen t 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.

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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.108 MRID Citation Reference

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92188019 Eigenberg, D. (1990) Mobay Corporation Phase 3 Summary of MRID 00155075 and Related MRIDs 00032541. MEB 6447 (Triad imefon) 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) Mu ltigeneration 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

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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.109 MRID Citation Reference

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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.

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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

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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.

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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. 68 905, 68906, 68907, 68908, 68909, 80723, 80930, 80931); Mobay Report No. 100117. Prepared by MOBAY CORPORATION. 55 p.

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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., Leav itt, 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-In115 Appendix E. The generic data call-in will be posted at a later date.116 Appendix F. Product Specific Data Call-In117 Appendix F. The product specific data call-in will be posted at a later date.118 Appendix G: Batching of Tria dimenol/Triadimefon Products

EPA'S BATCHING OF TRIADIMENOL/TRI ADIMEFON PRODUCTS FOR MEETING ACUTE TOXICITY DATA REQUI REMENTS FOR REREGISTRATION

In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity data requireme nts for reregistration of produc ts containing TRIADIMENOL or TRIADIMEFON as the active ingredient, the Ag ency has batched products which can be considered similar for purposes of acute toxici ty. Factors considered in the sorting process include each product's active and inert ingr edients (identity, percent composition and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., si gnal word, use classifi cation, 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 pa ragraph. Notwithstanding the ba tching process, the Agency reserves the right to re quire, at any time, acute toxicity data for an individual product should

the need arise.

Registrants of products within a batch ma y choose to cooperatively generate, submit or cite a single battery of si x 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 registrant s, or only their own products w ithin a batch, or to generate all the required acute toxicological studies fo r each of their own products. If a registrant chooses to generate the data for a batch, he/she must use one of the pr oducts within the batch

as the test material. If a re gistrant chooses to rely upon prev iously submitted acute toxicity data, he/she may do so provided th at the data base is complete and valid by today's standards (see acceptance criteri a 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 da ta. 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 statem ent of formula (CSF) exists for a product, the registrant must indicate the formulation actua lly tested by identifying the corresponding CSF.

In deciding how to meet the product specifi c 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 fo rms 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 re quirements for each product. The second form, "Requirements Status and Registrant's Response, " lists the product specif ic data required for each product, including the standard six acute toxi city 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 must119 select one of the following options: Devel oping 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 de pends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Optio n 3) or Citing an Exis ting Study (Option 6). If a registrant does not want to participate in a batch, the choi ces are Options 1, 4, 5 or 6. However, a registrant should know that choos ing not to participat e in a batch does not preclude other registrants in the batch from c iting his/her studies and offering to cost share (Option 3) those studies.

Seven products were found which contain Tria dimenol as the active ingredient. These products have been placed in a no batch gr oup in accordance with the active and inert ingredients and type of formulation

Batching Instructions for Triadimenol :

No Batch: Each product in this Ba tch should generate their own data.

NOTE: The technical acute toxicity values incl uded 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 Tr iadimefon 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 Ba tch should generate their own data.

NOTE: The technical acute toxicity values incl uded 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 0.78121 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 1.00122 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 27709123 Appendix I. List of Available Related Do cuments and Electronically Available Forms

Pesticide Registration Forms are availa ble 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. (Not e: 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 re quest, to the address below for the Document Processing Desk.

DO NOT fax or e-mail any form containing 'Confi dential 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 Form s are currently availa ble 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) h ttp://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf.

8570-36 Summary of th e 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/pesticid es/registrationkit/.

Dear Registrant:

For your convenience, we have assembled an online registration kit which contains the following pertinent forms and information n eeded 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 Pe sticide Products Policy Statement

f. 90-1 Inert Ingredients in Pes ticide Products; Revised Policy Statement

g. 95-2 Notifications, Non-notif ications, and Minor Formulation Amendments

h. 98-1 Self Certification of Produc t Chemistry Data with Attachments (This document is in PDF format a nd requires the Acrobat reader.)

Other PR Notices can be found at http://www.epa.gov/opppmsd1/PR_Notices.

3. Pesticide Product Registration Appli cation 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 Formula125 c. EPA Form No. 8570-27, Formulator's Exemption Statement

d. EPA Form No. 8570-34, Certificatio n 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 Prev ention Division (BPPD) Contacts

c. Antimicrobials Division Organi zational Structure/ Contact List

d. 53 F.R. 15952, Pesticide Regist ration Procedures; Pesticide Data Requirements (PDF format)

e. 40 CFR Part 156, Labeling Requi rements for Pesticides and Devices (PDF format)

f.. 40 CFR Part 158, Data Requireme nts for Registration (PDF format)

g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)

Before submitting your application for regi stration, 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 A pplying for Registration of Pesticides in the United States", PB92-221811, avai lable 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 subs criptions and custom searches. You can contact NPIRS by telephone at (765 ) 494-6614 or through their Web site.

4. The National Pesticide Telecommunica tions Network (NPTN) can provide information on active ingredients, us es, 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 pe rmit, or amendment to a petition if the applicant or petitione r encloses with his s ubmission a stamped, selfaddressed postcard. The postcard must c ontain 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 sp ecific application submitted. EPA will stamp the date of receipt and provide the EPA identifying File Symbol or petition number for the new submissi on. 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, comp any 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 sy stem (CAS) number if one has been assigned.

Documents Associated with this RED

The following documents are part of th e Administrative Record for this RED document and may be included in the EPA's Of fice of Pesticide Programs Public Docket. Copies of these documents are not availa ble electronically, but may be obtained by contacting the person listed on the respective Chemical Status Sheet.

1. Health Effects Division and Environm ental Fate and Effects Division Science Chapters, which include the complete risk assessments and supporting
documents.

2. Detailed Label Usage Information System (LUIS) Report.