Document ID: EPA-HQ-OPP-2006-0038-0038
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-02-22T05:00Z

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

			Environmental Protection 		And Toxic Substances		August 2006

			Agency				(7508P)

			_________________________________________________________________

  SEQ CHAPTER \h \r 1 Reregistration Eligibility    Decision for

Triadimefon

 

And

Tolerance Reassessment for Triadimenol

List B

Case No. 2700

  SEQ CHAPTER \h \r 1 

Reregistration Eligibility Decision (RED) Document for Triadimefon 

and 

Tolerance Reassessment for Triadimenol

Approved by:	___________________                      

			Debra Edwards, Ph. D.

			Director

			Special Review and Reregistration Division

			

			Date:	TABLE OF CONTENTS

  TOC \o "1-5" \u  Triadimefon Reregistration Eligibility Decision Team
i

Glossary of Terms and Abbreviations	ii

ABSTRACT	1

I.		Introduction	1

II. 	Chemical Overview	3

A.		Regulatory History	3

B.		Chemical Identification	4

    1. 	Technical Triadimefon	4

    2.	Triadimenol	5

    3. 	Triazole Metabolites	5

		  a.  1,2,4-Triazole	6

		  b.  Triazole Alanine	6

		  c.   Triazole Acetic Acid	6

C.		 Use Profile	7

     1.  Triadimefon	7

     2.  Triadimenol	8

D.		 Estimated Usage of Pesticide	9

	    1.	 Triadimefon	9

 	    2.	 Triadimenol	9

III. 	  Summary of Risk Assessments	9

A.	  Human Health Risk Assessment	10

1.	   Toxicity of Triadimefon and Triadimenol	11

		 a.  Acute Toxicity Profile	11

		 b.  FQPA Special Safety Factor Considerations	13

	    c.  Toxicological Endpoints	13

2.    Carcinogenicity	15	

3.    Endocrine Effects	16

4.    Dietary Exposure and Risk	16

	    a.  Dietary (Food) Risk Assessment	17

		   1) Acute Dietary Food Risk	17

		   2) Chronic Dietary Food Risk	18

	    b.  Dietary Exposure from Drinking Water	19 

	    c.  Dietary Risk from Drinking Water	20

		   1) Acute Dietary Water Risk	20

		   2) Chronic Dietary Water Risk	21

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

	    a.  Residential Handler Risk	22

	    b.  Residential Post-application Exposure and Risks	24

6.    Aggregate Exposure/Risk from Triadimefon and Triadimenol	25

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

	    Metabolites	28 

8.	   Cumulative Risk Assessment	29

9.	   Occupational Risk	29

	   a.  Occupational Toxicity	30

	   b.  Occupational Handler Exposure	31

	   c.  Occupational Handler Risk Summary	32

	   d.  Occupational Post-application Risk Summary	37

10. Human Incident Data	37

B.  	      Environmental Fate and Effects Risk Assessment	38

 1.   Environmental Fate and Transport	39

2.   Ecological Exposure and Risk	39	         	   a.  Aquatic Organism
Exposure and Risk	40

	   	   1)  Fish, Invertebrate, and Aquatic Plant Toxicity	40

	         2)  Fish and Invertebrate Exposure	42

 	         3)  Fish and Invertebrate Risk	43

	   	   4)  Non-target Aquatic Plants	43

	    b.  Terrestrial Organism Exposure and Risk	44

	         1)  Bird and Mammal Toxicity	44

	  	   2)  Bird and Mammal Exposure	46

	  	   3)  Bird and Mammal Risk	46

	  	   4)  Non-target Terrestrial Plants	48

	         5)  Non-target Insects	49

	      3.   Ecological Incidents	49	      4.   Endangered Species	49

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

A.		   Determination of Reregistration Eligibility and Tolerance
Reassessment	49

B.		   Public Comments and Responses	50

C.		   Regulatory Position under the FFDCA	50

1.	   Food Quality Protection Act Findings	50

	   a.  “Risk Cup” Determination	50

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

	   c.   Determination of Safety to Infants and Children	51

	   d.   Endocrine Disruptor Effects	51

	   e.	   Cumulative Risks	52

	2.   Tolerance Summary for Triadimefon	52

	   a.   Tolerances Currently Listed Under 40 CFR §180.410	52

	   b.   Codex Harmonization	55

	   c.	   Residue Analytical Methods – Plants/Livestock	55

	3.	Tolerance Summary for Triadimenol	56

		   a.  Tolerances Currently Listed Under 40 CFR §180.450	56

D.		   Regulatory Rationale	58

	1.   Human Health Risk Management	59

		   a.   Dietary (Food and Water) Risk Mitigation	59

	   b.   Residential Risk Mitigation	59

	   c.	   Occupational Risk Mitigation	60

	   d.   Aggregate Risk Mitigation for Triazole Metabolites	61   

		2.   Environmental Risk Mitigation	61

		3.   Other Labeling	61

		4.   Endangered Species Program	61

V.	    What Registrants Need to Do	62

A.		    Manufacturing Use Products	64

  1.   Generic Data Requirements for Triadimefon	64

  2.   Labeling for Manufacturing Use Products	65

B.		    End-Use Products	65

   1.  Additional Product-Specific Data Requirements	65

   2.  Labeling for End-Use Products	65

C.			Data Requirements for Triadimenol	65

D.		    Labeling Changes Summary Table	66

 VI. 	    Appendices	79

   A.         Use Patterns Subject to Reregistration for Triadimefon	83

   B.         Table of Generic Data Requirements and Studies Used to
Make the                             	    Reregistration Decision	83 

   C.         Technical Support Documents	94

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

             Eligibility Decision (Bibliography) for Triadimefon and
Triadimenol	97

E.          Generic Data Call-In	114

F.          Product Specific Data Call-In	116

G.          Batching of Triadimenol/Triadimefon Products	118

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

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

    		

      SEQ CHAPTER \h \r 1 Triadimefon Reregistration Eligibility
Decision Team  TC "Nitrapyrin Reregistration Eligibility Decision Team"
\f C \l "1"  

Office of Pesticide Programs:

Biological and Economic Analysis Assessment

Andrew Lee

Jenna Carter

Jin Kim

Tara Chandgoyal

Environmental Fate and Effects Risk Assessment

Michelle Embry

Jonathan Angier

Fred Jenkins

Dana Spatz

Health Effects Risk Assessment

Samuel Ary

Judy Facey

Shanna Recore

Richard Griffin

Michael Doherty

Alan Nielsen

Sheila Piper

Yvonne Barnes

Registration Support

Tony Kish

Risk Management

John W. Pates, Jr.

Kelly Sherman

Veronique LaCapra

Office of General Counsel

Erin Koch

  SEQ CHAPTER \h \r 1 Glossary of Terms and Abbreviations  TC "Glossary
of Terms and Abbreviations" \f C \l "1"  

AGDCI		Agricultural Data Call-In

ai			Active Ingredient

aPAD			Acute Population Adjusted Dose

AR			Anticipated Residue

BCF			Bioconcentration Factor 

CFR			Code of Federal Regulations

cPAD			Chronic Population Adjusted Dose

CSF			Confidential Statement of Formula

CSFII			USDA Continuing Surveys for Food Intake by Individuals

DCI			Data Call-In

DEEM			Dietary Exposure Evaluation Model

DFR			Dislodgeable Foliar Residue

DWLOC		Drinking Water Level of Comparison.

EC			Emulsifiable Concentrate Formulation

EEC			Estimated Environmental Concentration

EPA			Environmental Protection Agency

EUP			End-Use Product

FDA			Food and Drug Administration

FIFRA			Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA		Federal Food, Drug, and Cosmetic Act

FQPA			Food Quality Protection Act

FOB			Functional Observation Battery

G			Granular Formulation

GENEEC		Tier I Surface Water Computer Model

GLN			Guideline Number

HAFT			Highest Average Field Trial

IR			Index Reservoir

LC50			Median Lethal Concentration.  A statistically derived
concentration of a substance that can be expected to cause death in 50%
of test animals.  It is usually expressed as the weight of substance per
weight or volume of water, air or feed, e.g., mg/l, mg/kg or ppm.

LD50			Median Lethal Dose.  A statistically derived single dose that can
be expected to cause death in 50% of the test animals when administered
by the route indicated (oral, dermal, inhalation).  It is expressed as a
weight of substance per unit weight of animal, e.g., mg/kg.

LOC			Level of Concern

LOD			Limit of Detection 

LOAEL		Lowest Observed Adverse Effect Level

MATC			Maximum Acceptable Toxicant Concentration

g/g			Micrograms Per Gram

g/L			Micrograms Per Liter

mg/kg/day		Milligram Per Kilogram Per Day

mg/L			Milligrams Per Liter

MOE			Margin of Exposure 

MRID			Master Record Identification (number).  EPA's system of recording
and tracking studies submitted.

MUP			Manufacturing-Use Product

NA			Not Applicable

NAWQA		USGS National Water Quality Assessment

NPDES		National Pollutant Discharge Elimination System

NR			Not Required

NOAEL		No Observed Adverse Effect Level

OP			Organophosphate

OPP			EPA Office of Pesticide Programs

OPPTS		EPA Office of Prevention, Pesticides and Toxic Substances

PAD			Population Adjusted Dose

PCA			Percent Crop Area

PDP			USDA Pesticide Data Program

PHED			Pesticide Handler's Exposure Data 

PHI			Preharvest Interval

ppb			Parts Per Billion

PPE			Personal Protective Equipment

ppm			Parts Per Million

PRZM/EXAMS	Tier II Surface Water Computer Model  

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

RAC			Raw Agriculture Commodity

RED			Reregistration Eligibility Decision

REI			Restricted Entry Interval

RfD			Reference Dose

RQ			Risk Quotient

SCI-GROW		Tier I Ground Water Computer Model

SAP			Science Advisory Panel

SF			Safety Factor

SLC			Single Layer Clothing

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

TGAI			Technical Grade Active Ingredient

TRR			Total Radioactive Residue

USDA			United States Department of Agriculture

USGS			United States Geological Survey

UF			Uncertainty Factor

UV			Ultraviolet 

WPS			Worker Protection Standard

  SEQ CHAPTER \h \r 1 ABSTRACT

	The Environmental Protection Agency (EPA or the Agency) has completed
the human health and environmental risk assessments for triadimefon and
the dietary and aggregate assessments for triadimenol, and is issuing
its risk management reregistration decision and tolerance reassessment. 
The risk assessments, which are summarized below, are based on the
review of the required target database supporting the use patterns of
currently supported products and additional information received through
the public docket.  

	The Agency discussed the dietary risks of concern (food + water) with
the registrant, and the registrant has proposed a number of changes to
its triadimefon registration including the voluntary deletion of all
food (except pineapples) and residential turf use, and a reduction of
application rates and frequencies.  In doing so, this document has
estimated exposure and risk based on these new use patterns.  

	After considering the risks identified in the revised risk assessments,
comments received, and mitigation suggestions from interested parties,
the Agency developed its risk management reregistration decision for
uses of triadimefon and tolerance reassessment for triadimenol.  As a
result of this review, EPA has determined that triadimefon-containing
products are eligible for reregistration, provided that risk mitigation
measures are adopted and labels are amended accordingly.  Furthermore,
the tolerances for triadimefon and triadimenol are considered reassessed
and regulatory action under the Federal Food, Drug and Cosmetic Act
(“FFDCA”) will occur after the uses that do not meet the Federal
Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) standard are
canceled.  These decisions are discussed fully in this document.  

  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 I. 	Introduction  TC "I. 
Introduction" \f C \l "1"  

FIFRA was amended in 1988 to accelerate the reregistration of products
with active ingredients registered prior to November 1, 1984.  The
amended Act calls for the development and submission of data to support
the reregistration of an active ingredient, as well as a review of all
submitted data by the EPA.  Reregistration involves a thorough review of
the scientific database underlying a pesticide's registration.  The
purpose of the Agency's review is to reassess the potential risks
arising from the currently registered uses of the pesticide, to
determine the need for additional data on health and environmental
effects, and to determine whether or not the pesticide meets the "no
unreasonable adverse effects" criteria of FIFRA.

On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was
signed into law.  This Act amends FIFRA and the FFDCA to require
reassessment of all existing tolerances for pesticides in food.  FQPA
also requires EPA to review all tolerances in effect on August 2, 1996,
by August 3, 2006.  In reassessing these tolerances, the Agency must
consider, among other things, aggregate risks from non-occupational
sources of pesticide exposure, whether there is increased susceptibility
to infants and children, and the cumulative effects of pesticides with a
common mechanism of toxicity.  When a safety finding has been made that
aggregate risks are not of concern and the Agency concludes that there
is a reasonable certainty of no harm from aggregate exposure, the
tolerances are considered reassessed.  EPA decided that, for those
chemicals that have tolerances and are undergoing reregistration,
tolerance reassessment will be accomplished through the reregistration
process.   

  SEQ CHAPTER \h \r 1 As mentioned above, FFDCA requires that the Agency
consider “available information” concerning the cumulative effects
of a particular pesticide’s residues and “other substances that have
a common mechanism of toxicity” when considering whether to establish,
modify, or revoke a tolerance.  Potential cumulative effects of
chemicals with a common mechanism of toxicity are considered because
low-level exposures to multiple chemical substances that cause a common
toxic effect by a common mechanism of toxicity could lead to the same
adverse health effect that would occur at a higher level of exposure to
any one of these individual chemicals.  Triadimefon belongs to a group
of pesticides called triazoles (or conazoles), which also includes the
triazole fungicide subject to reregistration, propiconazole. 
Triadimenol, a metabolite of triadimefon, is also a registered fungicide
and is subject to tolerance reassessment.  For the purpose of this
reregistration eligibility decision (RED) for triadimefon and tolerance
reassessment for triadimenol, EPA has concluded that triadimefon and
triadimenol do not share a common mechanism of toxicity with other
substances.  However, the triazole fungicides share common metabolites,
the triazole compounds 1,2,4-triazole (free triazole), triazole alanine,
and triazole acetic acid, which are considered in this document.  For
information regarding EPA’s efforts to determine which chemicals have
a common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the policy statements released by EPA’s Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a common
mechanism on EPA’s website at   HYPERLINK
"http://www.epa.gov/pesticides/cumulative" 
http://www.epa.gov/pesticides/cumulative .  

The Agency has identified triazole metabolites of toxicological concern;
these include 1,2,4-triazole and the conjugates triazole alanine and
triazole acetic acid. Because these metabolites are formed from all
triazole pesticides, EPA has conducted a separate toxicology assessment
for these compounds and concluded that the existing data are sufficient
to support the reregistration of triadimefon and triadimenol.  For more
details on the toxicity of the free triazoles, see the August 5, 2003,
documents, TRIAZOLES – Report of the Ad Hoc HED Peer Review Committee,
TRIAZOLES – 2nd Report of the Ad Hoc HED Peer Review Committee, and
the February 7, 2006, document, 1,2,4-Triazole, Triazole Alanine,
Triazole Acetic Acid: Human Health Aggregate Risk Assessment in Support
of Reregistration and Registration Actions for Triazole-derivative
Fungicide Compounds, which are available under docket number
EPA-HQ-OPP-2005-0258.  Because the risks associated with the free
triazoles are all below the Agency’s level of concern, they are not
discussed further in this document.  For more information regarding the
aggregate assessment of free triazoles, see the July 18, 2006, document,
Reregistration Eligibility Decision (RED) for Propiconazole, in the
Agency’s electronic docket on the internet at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  under docket
number EPA-HQ-OPP-2005-0497.

Triadimefon and triadimenol also share a common metabolite,
1,2,4-triazole, with several triazole-derivative pharmaceutical
compounds.  Thus, EPA must consider the incremental impact of exposure
to 1,2,4-triazole pesticide residues to individuals using
triazole-derivative pharmaceutical products.  To this end, EPA worked
with the U.S. Food and Drug Administration (FDA), which has regulatory
authority for drug products, to assess the risks posed by 1,2,4-triazole
residues that could result from concurrent exposure to
triazole-derivative pharmaceutical and pesticide products.  This
assessment will provide the basis of safety findings reflecting the
joint perspectives of FDA and EPA, and will inform a decision by both
Agencies about whether appropriate measures are needed to reduce
exposure from one or both sources of 1,2,4-triazole residues.  

This document presents a summary of EPA’s revised human health and
ecological risk assessments, its reregistration eligibility decision for
triadimefon and tolerance reassessment decision for triadimenol. 
Occupational and ecological risks from exposure to the pesticidal uses
of triadimenol are not addressed in this document.  The document
consists of six sections. Section I contains the regulatory framework
for reregistration/tolerance reassessment.  Section II provides a
profile of the use and usage of the chemicals.  Section III gives an
overview of the revised human health and environmental effects risk
assessments based on data, public comments, and other information
received in response to the preliminary risk assessments.  Section IV
presents the Agency’s reregistration eligibility, risk management and
tolerance reassessment decisions.  Section V summarizes label changes
necessary to implement the risk mitigation measures outlined in Section
IV.  Finally, the Appendices list related and supporting documents.  The
revised risk assessments for triadimefon and triadimenol are available
in the Agency’s electronic docket on the internet at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  under docket
number EPA-HQ-OPP-2005-0258 and EPA-HQ-OPP-2006-0038, respectively.

II. 	Chemical Overview  TC "II. 	Chemical Overview" \f C \l "1"  

	A.	Regulatory History  TC "A.	Regulatory History" \f C \l "2"  

Triadimefon

 Triadimefon is a broad spectrum, systemic fungicide used to control
rust and mildew on apples, grapes, pears, pineapples, and raspberries. 
In addition, it is used to control various fungal diseases on non-food
use sites such as pine seedlings, Christmas trees, residential and
commercial turf, ornamentals, and landscapes.  There are tolerances for
triadimefon on apples, grapes, pears, pineapples, and raspberries. 
Triadimefon end-use products are marketed in the United States under the
trade names Bayleton and Summit.  There are nineteen active products
containing triadimefon (one technical product) registered under Section
3 of FIFRA.  

The registrant has agreed to delete all food (except pineapple) and
residential turf uses.  Therefore, this Reregistration Eligibility
Decision document evaluates risks from all currently supported uses of
triadimefon.  The Agency will follow the FIFRA cancellation with the
appropriate tolerance revocations.

Triadimenol

The primary metabolite of triadimefon is triadimenol.  Triadimenol,
which degrades to include the metabolites KWG 1323 and KWG 1342, is also
registered separately as a broad spectrum, systemic fungicide under its
own active ingredient number (PC code: 127201).  Triadimenol is used
exclusively in the U.S. as a seed treatment for cotton and grains.  As a
result, it is also being assessed by the Agency for the purposes of a
tolerance reassessment eligibility decision (TRED).  Triadimenol was
first registered after 1984 and is not subject to reregistration under
the 1988 amendments to FIFRA.

Chemical Identification

1.	Technical Triadimefon

 

  TC "B. 	Chemical Identification" \f C \l "2"  

Common Name:		Triadimefon

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

Chemical Family:		Azole (Triazoles)

Empirical Formula:		  SEQ CHAPTER \h \r 1 C14H16CLN3O2

CAS Registry Number:	43121-43-3

Case Number:		2700

OPP Chemical Code: 	109901

Molecular weight:		293.75 g/mol

Trade Names:		Bayleton and Summit

Basic Manufacturers:	Bayer CropScience, LC

Triadimefon has a melting point of 82.3 degrees Celsius, a solubility of
64 mg/L ppm in water 20 degrees Celsius and a vapor pressure of 0.2 –
0.6 mPa at 20 and 25 degrees Celsius, respectively (7.6 x 10-7 mm Hg).

2.	Triadimenol

 

Common Name:		Triadimenol

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

Chemical Family:		Azole (Triazoles)

Empirical Formula:		C14H18ClN3O2

  SEQ CHAPTER \h \r 1 

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

	

	Triazole Metabolites

Triadimefon, triadimenol, and other triazole fungicides are metabolized
in animals and plants to form compounds containing the triazole moiety,
including 1,2,4-triazole (free triazole), triazole alanine, and triazole
acetic acid, which are also considered in this decision.  Since triazole
alanine and triazole acetic acid are formed by conjunction with an amino
acid, they are referred to as triazole conjugates throughout this
document.  Chemical information for these triazole metabolites is
provided below.

a.	1,2,4-Triazole

 

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

Triazole Alanine

 

Chemical Name:	Triazole Alanine (TA)

CAS No.:	86362-20-1

PC Code:	600011

Molecular Weight:	156.15

Triazole Acetic Acid

 

Chemical Name: 	Triazole Acetic Acid (TAA)

CAS No.:		28711-29-7

PC Code:		600082

Molecular Weight:	127.10

  SEQ CHAPTER \h \r 1 C. 	Use Profile  TC "C. 	Use Profile" \f C \l "2" 

	

Triadimefon

The following is information on the currently registered uses of
triadimefon, including an overview of use sites and application methods.
 A detailed table of the uses of triadimefon eligible for reregistration
is contained in Appendix A.

Type of Pesticide:  	Broad spectrum, systemic fungicide; demethylation
inhibitor (DMI).

Summary of Use:	Used for the systemic control of various fungal diseases
in fruits, turf, pine seedlings, Christmas trees, and ornamentals. 

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

					(Registrant is voluntarily deleting use on apples, grapes, 				
pears, and raspberries).

Non-food uses:	Pine seedlings, Christmas trees, residential and
commercial turf, ornamentals, and landscapes.

	(Registrant is voluntarily deleting residential turf use).

Formulation Type: 	Registered formulations include granular (G)(0.5-1%
active ingredient), wettable powder (WP)(25-50% active ingredient),
water soluble packets (50% active ingredient), liquid concentrate
(LC)(0.88% active ingredient), and ready-to-use (RTU)(0.5% active
ingredient). 

Registrant(s):	Bayer CropScience, LP

Method and Rates of Application:	

Application Methods:	Applied via ground spray, airblast, aerial spray ,
chemigation, and broadcast (granular only) to apples, pears,
raspberries, grapes, Christmas trees, ornamentals, pine seedlings, and
turf (golf course, residential, commercial, and recreational).  It is
also used as a post-harvest 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.

	Current maximum application rates are a 5.4 lb. ai/A treatment on turf
(California only) and a 2.7 lb. ai/A treatment on turf outside of
California.  A maximum rate of 0.75 lbs ai/A may be used as a
pre-harvest foliar treatment on apples and pears (up to 12X per season),
0.56 lbs ai/A for grapes (up to 6X per season), and 0.88 lbs ai/A for
raspberries (up to 7X per season).  A maximum rate of 2.0 lbs ai/A may
be used for pre-harvest foliar treatment on both Christmas trees (up to
8X per season) and pine seedlings (up to 16X per season).  For
pineapple, a maximum rate of 0.28 lbs ai/100 gallons solutions may be
applied via dip and at a maximum rate of 0.28 lbs ai/100 gallons
solution via dip or spray to the whole fruit following harvest.  It is
also used as a pine seed soak (0.63 lbs ai/100 gal solution), and as a
pine seed treatment (0.063 lbs ai/100 gal solution, one time prior to
planting.

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

 

Use Classification:	General

		2.	Triadimenol

The following is information on the currently registered uses of
triadimenol, including an overview of use sites and application methods.
 A detailed table of the uses of triadimenol eligible for tolerance
reassessment is contained in Appendix A.

Type of Pesticide:  	Systemic fungicide for seed treatment.

Summary of Use:	Used as a seed treatment on: barley, corn, cotton, oats,
rye, sorghum, and wheat.  There is also an import tolerance on bananas.

Formulation Type: 	Registered formulations include emulsifiable
concentrate (EC) (5% active ingredient), wettable powder (WP)(25% active
ingredient), soluble concentrate (SC) (13.33% active ingredient), and
flowable concentrate (FlC) (28.3 - 30% active ingredient).

Registrant(s):	Bayer CropScience, LP

Method and Rates of Application:	

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

	Estimated Usage of Pesticide

1.	Triadimefon  TC "D.	Estimated Usage of Pesticide" \f C \l "2"  

Screening level estimates of triadimefon use in the U.S., based on data
from the years 1990 through 2000, have been provided by the Agency’s
Biological and Economic Analysis Division.  Total use averaged 135,000
lbs ai/year with an upper-end estimate of 266,000 lbs ai/year.  The
largest market, in terms of total pounds ai, was seen in the turf and
ornamental sector.

2.	Triadimenol

	Based on pesticide usage data for the years 1992 through 2001, total
annual domestic usage of triadimenol averaged approximately 24,000
pounds of active ingredient (a.i.) for over 12,000,000 acres treated. 
Use on cotton accounted for approximately 75 % of the total pounds of
a.i. applied annually.  Corn and wheat accounted for approximately 20%
and 5%, respectively.  About 80% of U.S. acreage planted to cotton is
treated with triadimenol, and less than 1 % of corn and wheat acres are
treated

	

  SEQ CHAPTER \h \r 1 III. 	Summary of Risk Assessments  TC "III. 
Summary of Nitrapyrin Risk Assessments" \f C \l "1"  

The following is a summary of EPA's human health and ecological risk
findings and conclusions for triadimefon and triadimenol, as presented
fully in the documents:

Triadimefon

Triadimefon. Preliminary Human Health Risk Assessment (Revised).
February 9, 2006

Triadimefon/Triadimenol: Summary of Refinements and Revisions to the
Human Health Risk Assessment.  July 10, 2006 

Triadimefon: Revised Acute, Probabilistic and Chronic Dietary (Food +
Drinking Water) Exposure and Risk Assessments for the Triadimefon
Reregistration.  July 6, 2006 

Environmental Fate and Effects Chapter (Revised), Risk Assessment for
Triadimefon.  January 19, 2006 

Triadimefon: HED Response to Comments Received During the Public Comment
Phase.  June 20, 2006

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

Triadimefon. Summary of Ana--lytical Chemistry and Residue Data for the
Reregistration Eligibility Decision (RED) Document.  November 23, 2005

Triadimefon: Occupational and Residential Exposure Assessment for the
Reregistration Eligibility Decision Document.  June 30, 2006

Triadimefon and Triadimenol: Aggregate Acute, Chronic, and Short-Term
Risk Assessments Reflecting July, 2006 Risk Mitigation in Response to
the Phase 4 Triadimefon RED.  August 1, 2006

Response to Bayer Public Comments Regarding the Environmental Fate and
Effects Division Triadimefon Risk Assessment. June 1, 2006

Tier 2 Drinking Water Assessment for Triadimefon and its Major Degradate
Triadimenol.  August 31, 2005

Triadimenol

Triadimenol: HED Chapter of the Tolerance Reassessment Eligibility
Decision (TRED) Document (Revised).  February 9, 2006

Triadimenol. Acute and Chronic Dietary Exposure Assessments for the
Tolerance Reassessment Eligibility Decision (TRED) Document.  November
18, 2005

The purpose of this section is to summarize the key features and
findings of the risk assessments in order to help the reader better
understand the risk management decisions reached by the Agency.  The
human health and ecological risk assessment documents and supporting
information listed in Appendix C were used to reach the safety finding
and regulatory decisions for triadimefon and triadimenol.  Although the
risk assessments and related addenda are not included in this document,
they are available from the OPP Public Docket OPP-2005-0258 and
OPP-2006-0038, and may also be accessed on the web at   SEQ CHAPTER \h
\r 1   HYPERLINK "http://www.regulations.gov" 
http://www.regulations.gov .  Hard copies of these documents may be
found in the OPP public docket under these same docket numbers.

 

A.	Human Health Risk Assessment

The human health risk assessment incorporates potential exposure from
all sources, which for triadimefon includes food, drinking water,
residential, and occupational scenarios and for triadimenol include food
and drinking water scenarios.  Aggregate assessments combine food,
drinking water, and any residential or other non-occupational (if
applicable) exposures to determine potential exposures to the U.S.
population.  

This document summarizes risk estimates for triadimefon (including its
metabolite triadimenol and degradates KWG 1342 and KWG 1732), and its
metabolites 1,2,4-triazole, triazole alanine, and triazole acetic acid,
which are formed from triazole compounds in animals and plants and may
be found in food commodities, including animal byproducts. 
1,2,4-Triazole appears to be relatively stable in the environment, and
may be found in rotational crops and drinking water.  A surface water
monitoring study showed detections of 1,2,4-triazole in a small number
of samples.  Therefore, EPA has considered the risks from food, drinking
water and non-occupational exposure resulting from triadimefon alone and
from the triazole metabolites from all pesticide sources.  For
triadimenol, since there are no residential uses, EPA considered
exposure and risk from food and drinking water   In addition, EPA has
also considered potential co-exposure to free triazoles resulting from
pharmaceutical uses of triazole compounds.  Because the risks associated
with the free triazoles from all sources are all below the Agency’s
level of concern, they are not discussed further in this document. 
Additional details regarding the risks associated with the free
triazoles, which includes contribution from triadimefon and
triadimenol,- may be found in the February 7, 2006, document,
1,2,4-Triazole, Triazole Alanine, Triazole Acetic Acid:  Human Health
Aggregate Risk Assessment in Support of Reregistration and Registration
Actions for Triazole Derivative Fungicide Compounds, which is available
in the public docket (EPA-HQ-OPP-2005-0258).  

	1.	Toxicity of Triadimefon and Triadimenol  TC "a.	Toxicity of
Nitrapyrin" \f C \l "4"  

Toxicity assessments are designed to predict whether a pesticide could
cause adverse health effects in humans (including short-term or acute
effects such as skin or eye damage, and lifetime or chronic effects such
as cancer, developmental and/or reproductive effects), and the level or
dose at which such effects might occur.  The Agency has reviewed all
toxicity studies submitted and has determined that the toxicity database
for triadimefon is adequate although there are data gaps (lack of a
developmental neurotoxicity study which the Agency will remedy through
the DCI).  In addition, the Agency has reviewed all toxicity studies
submitted for triadimenol and has determined that the database is
adequate.  The triadimenol data base is less definite than triadimefon;
however, because it is a metabolite of triadimefon the Agency believes
that the use of data on triadimefon can be used for triadimenol and be
protective regarding any potential risk concerns.  Therefore, the Agency
is not requiring a developmental neurotoxicity (DNT) study for
triadimenol.    SEQ CHAPTER \h \r 1 All other studies have been
submitted to support guideline requirements and a reregistration
eligibility determination for all currently registered uses.  For more
details on the toxicity of triadimefon, see the February 9, 2006,
document, Triadimefon. Preliminary Human Health Risk Assessment
(Revised), and the July 10, 2006, document, Triadimefon/Triadimenol:
Summary of Refinements and Revisions to the Human Health Risk
Assessment, which is available under docket number EPA-HQ-OPP-2005-0258.

Acute Toxicity Profile 

Triadimefon

Triadimefon is classified as category III for acute oral and dermal
toxicity and as category IV for acute inhalation.  It is also classified
as category IV for eye irritation potential and category IV for skin
irritation potential.  In addition, triadimefon caused dermal
sensitization in guinea pigs.  The acute toxicity profile for technical
grade triadimefon is summarized in Table 1 below.  The technical acute
toxicity values included in this document are only to provide background
information.  Additional acute toxicity data may be required to
determine appropriate cautionary label language for products containing
triadimefon.  

Table 1.  Acute Toxicity Profile for Triadimefon

Old Guideline

 No.	New Guideline No.	

Study Type	

MRID #(s)	

Results	Toxicity Category

81-1	870.1100	Acute Oral - rat	

264276	LD50 =  1,470 mg/kg (Males)

LD50 =  1,090 mg/kg    (Females)	III

81-2	870.1200	Acute Dermal -

Rabbit	264276	LD50 > 2,000 mg/kg	III

81-3	870.1300	Acute Inhalation - rat	

41616002	LC50 > 3.570 mg/L	IV

81-4	870.2400	Acute (Primary) Eye Irritation - rabbit	

41782501	Slightly irritating 	IV

81-5 	870.2500	Acute (Primary) Dermal (Skin) Irritation - rabbit	

41616004	Not an irritant	IV

81-6	870.2600	Skin (Dermal) Sensitization – guinea pig	

41554001	Sensitizer	Not Applicable

Triadimenol

	Triadimenol shows low toxicity for acute oral, dermal, and inhalation
exposure  (toxicity Category III or IV) and is not a skin sensitizer. 
Triadimenol is an eye irritant with irritation clearing in 21 days or
longer (toxicity Category II), and is a mild dermal irritant (toxicity
Category IV).  The acute toxicity profile for technical triadimenol is
summarized in Table 2 below.  

Table 2:  Acute Toxicity Profile for Triadimenol 

Old Guideline No.

 	

New Guideline No.	

Study Type	

MRID #(s)	

Results	

Toxicity Category

81-1	

870.1100	

Acute oral –rat	

00125411	

LD50 = 689 mg/kg (males)

LD50 = 752 mg/kg (females)	

III

81-2	

870.1200	

Acute dermal – rabbit	

00145086	

LD50 > 2000 mg/kg	

III

81-3	

870.1300	

Acute inhalation – rat	

00145087	

LC50 > 2.58 mg/L (Limit Dose)	

IV

81-4	

870.2400	

Acute eye irritation – rabbit	

00145088	

eye irritant. Irritation cleared in 21 days or longer.	

II

81-5 	

870.2500	

Acute dermal irritation – rabbit	

00145088	

mild skin dermal irritation	

IV

81-6	

870.2600	

Skin sensitization- guinea pig	

00125413	

Not a skin sensitizer	

Not Applicable

		

		b.	FQPA Safety Factor Considerations  TC "b.	FQPA Safety Factor" \f C
\l "4"  

  SEQ CHAPTER \h \r 1 The FFDCA as amended by the FQPA directs the
Agency, in setting pesticide tolerances, to use an additional tenfold
(10X) margin of safety to protect infants and children, taking into
account the potential for pre- and post-natal toxicity and the
completeness of the toxicology and exposure databases.  The statute
authorizes the Agency to reduce this tenfold FQPA safety factor (SF)
only if reliable data demonstrate that the resulting level of exposure
would be safe for infants and children.

Triadimefon

The current developmental and reproductive toxicity studies do not
suggest that the young are more sensitive than adult animals.  However,
since the triadimefon database does not include a DNT study, an FQPA
safety factor for database uncertainty (10X) has been retained for
exposure scenarios through which exposure to children or pregnant women
is expected.  A DNT study is required for triadimefon and the Agency
will issue a DCI for this data.

Triadimenol

	The endpoint of concern for triadimenol, like triadimefon, is
neurotoxicity, which was observed in rat, mice, and rabbit studies. 
Evidence of increased susceptibility to offspring was not seen in
available developmental toxicity studies in two species (rabbits and
rats) and in a two-generation reproductive toxicity study in rats. 
Therefore, the Agency is not requiring a developmental neurotoxicity
(DNT) study for triadimenol at this time, pending the results of the
acute and subchronic neurotoxicity studies listed in section V of this
document.  However, the Agency is retaining the FQPA Safety Factor (10X)
for database uncertainty for lack of both acute and subchronic
neurotoxicity studies.

 			c.        Toxicological Endpoints 

Triadimefon

Table 3 summarizes the studies, toxicological endpoints, dose levels,
and uncertainty/safety factors selected for the assessment of dietary,
oral, dermal, and inhalation exposure to triadimefon.  Since no
appropriate acute endpoint could be determined from the triadimenol
database, the triadimefon subchronic neurotoxicity study in rats was
chosen for the acute reference dose (aRfD) for triadimenol, as well.  In
addition, the subchronic neurotoxicity study for triadimefon was also
chosen for the chronic reference dose (cRfD) for triadimenol. 
Therefore, the endpoint of concern is neurotoxicity and is the same for
both triadimefon and triadimenol.

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

Intermediate-Term

(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 

Intermediate-Term

(1 - 6 months)	

NOAEL = 3.4 mg/ kg/day  

(Inhalation absorption rate = 100%)

UF = 100	Residential MOE = 1000

FQPA SF = 10X

Occupational MOE = 100	

Subchronic neurotoxicity study in rats (MRID 44153501).

LOAEL = 54.6 mg/kg/day (M) and 68.7 mg/kg/day (F) based largely on
hyperactivity.

Cancer (oral, dermal, inhalation)	

Classification: Category C (possible human carcinogen) based on
statistically significant increase in thyroid adenomas in male Wistar
rats and statistically significant increases in hepatocellular adenomas
in both sexes of the NMRI mouse. 

UF, uncertainty factor; SF, safety factor; NOAEL, no observable adverse
effect level; LOAEL, lowest observable adverse effect level; RfD,
reference dose, exposure which is not expected to exceed EPA’s level
of concern; PAD, population adjusted dose, which is the RfD adjusted for
the FQPA safety factor (SF); MOE, margin of exposure; LOC, Level of
Concern, MOE at and above which the Agency does not have a risk concern.
 NA, Not Applicable.

Triadimenol

Table 4 summarizes the studies, toxicological endpoints, dose levels,
and uncertainty/safety factors selected for the assessment of dietary
exposure to triadimenol.  The endpoint of concern is neurotoxicity (same
as triadimefon).  

Table 4.  Summary of Doses and Toxicological Endpoints for Triadimenol

Exposure

Scenario	Dose, Uncertainty Factors (UF)	FQPA Safety Factor (SF) and
Level of Concern	

Study and Toxicological Effects

Acute Dietary

(general population)	

 NOAEL = 3.4 mg/kg/day (subchronic)

UF = 100

Acute RfD = 0.034 mg/kg/day 	FQPA SF = 10X

aPAD = acute RfD

              FQPA SF

aPAD = 0.0034 mg/kg/day	

Subchronic neurotoxicity study in rats (MRID 44153501) for triadimefon.

LOAEL = 54.6 mg/kg/day (M) and 68.7 mg/kg/day (F) based largely on
hyperactivity.

Chronic Dietary

(all populations)	

NOAEL = 3.4 mg/kg/day

UF = 100

Chronic RfD = 0.034 mg/kg/day	FQPA SF = 10X

cPAD = chronic RfD

              FQPA SF

cPAD = 0.0034 mg/kg/day	

Subchronic neurotoxicity study in rats (MRID 44153501) for triadimefon.

LOAEL = 54.6 mg/kg/day (M) and 68.7 mg/kg/day (F) based largely on
hyperactivity.

Cancer 

(oral, dermal, inhalation)	Classification:  Category C “possible human
carcinogen” based on increased incidence of hepatocellular adenomas in
females.

2.	Carcinogenicity

Triadimefon

The Cancer Assessment Review Committee (CARC) assigned  SEQ CHAPTER \h
\r 1  triadimefon a classification of "possible human carcinogen", using
the criteria in the Draft Guidelines for Carcinogen Risk Assessment
(July, 1999).  This classification is based on a statistically
significant increase in thyroid adenomas in male Wistar rats and
statistically significant increases in hepatocellular adenomas in both
sexes of the NMRI mouse.  However, the Agency concluded that a
quantified carcinogenic risk assessment for triadimefon is not
appropriate and risk assessment will be based on the chronic population
adjusted dose (cPAD) and margin of exposure (MOE) approaches only. 

Triadimenol

	The CARC has assigned triadimenol a classification of “possible human
carcinogen”, using the criteria in the Draft Guidelines for Carcinogen
Risk Assessment (July, 1999).  This classification is based on increased
incidence of hepatocellular adenomas in females.  However, the Agency
concluded that a quantified carcinogenic risk assessment for triadimenol
is not appropriate and risk assessment will be based on the chronic
population adjusted dose (cPAD) and margin of exposure (MOE) approaches
only.

		3.	Endocrine Effects

EPA is required under the FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including all
pesticide active and other ingredients) “may have an effect in humans
that is similar to an effect produced by a naturally occurring estrogen,
or other such endocrine effects as the Administrator may designate.” 
Following recommendations of its Endocrine Disruptor and Testing
Advisory Committee (EDSTAC), EPA determined that there was a scientific
basis for including, as part of the program, the androgen and thyroid
hormone systems, in addition to the estrogen hormone system.  EPA also
adopted EDSTAC’s recommendation that the Program include evaluations
of potential effects in wildlife.  For pesticide chemicals, EPA will use
FIFRA and, to the extent that effects in wildlife may help determine
whether a substance may have an effect in humans, FFDCA authority to
require the wildlife evaluations.  As the science develops and resources
allow, screening of additional hormone systems may be added to the
Endocrine Disruptor Screening Program (EDSP).  

Triadimefon and Triadimenol

	The toxicity databases for triadimefon and triadimenol did not show any
estrogen, androgen, or thyroid mediated toxicity. 

		4.	Dietary Exposure and Risk  TC "c.	Population Adjusted Dose" \f C \l
"4"  

	The registrant has agreed to voluntarily cancel all food (apples,
pears, grapes, and raspberries), except pineapple, and residential turf
use for triadimefon.  Thus, these uses were not included in this dietary
risk assessment.  In addition, the registrant is only supporting a
maximum turf rate of 2 applications of 2.7 lbs. ai/A for golf courses
and sod farms.  Therefore, all drinking water risk estimates were
calculated using this rate.

Dietary risk assessments consider exposure to pesticide residues from
both food and drinking water.  In examining dietary risk, exposures from
the use of triadimefon, which includes the parent and its metabolites,
including triadimenol, as well as exposures from the use of triadimenol,
which includes the parent and its metabolites, must be added together. 
This is due to the fact that both the acute and chronic PADs are based
on the same study (a subchronic neurotoxicity study in rats exposed to
triadimefon) and therefore must be aggregated.  To estimate dietary
risks from food and drinking water, EPA compares the estimated exposure
to pesticide residues in food and drinking water to the acute or chronic
population adjusted dose, or PAD.  The PAD is the reference dose (RfD)
adjusted for the FQPA safety factor.  A risk estimate that is less than
100% of the acute PAD (aPAD), the dose at which an individual could be
exposed over the course of a single day and no adverse health effects
would be expected, does not exceed EPA’s level of concern.  Likewise,
a risk estimate that is less than 100% of the chronic PAD (cPAD), the
dose at which an individual could be exposed over the course of a
lifetime and no adverse health effects would be expected, does not
exceed EPA’s level of concern. Additional details about the dietary
risk assessment for triadimefon and triadimenol are described in the
July 6, 2006, document, Triadimefon. Revised Acute and Chronic Dietary
(Food + Drinking Water) Exposure and Risk Assessments for the
Triadimefon Reregistration and in the February 9, 2006, document,
Triadimenol: HED Chapter of the Tolerance Reassessment Eligibility
Decision (TRED) Document (Revised).

	Acute PAD.  As discussed in Section III of this document, the Agency
used the subchronic neurotoxicity study (SCN) for triadimefon to
establish the acute RfD that is used for both chemicals.  The endpoint
of concern is neurotoxicity seen after both an acute gavage and repeated
dietary exposure.  The NOAEL was 3.4 mg/kg/day.  The aPAD is 0.0034
mg/kg/day.  Dietary risk results >100% of the aPAD are above the
Agency’s level of concern.  Refer to Table 3 above.

	Chronic PAD.  Combined dietary risk for triadimefon and triadimenol was
assessed by comparing chronic dietary exposure estimates (in mg/kg/day)
to the triadimefon cPAD.  Dietary risk is expressed as a percent of the
cPAD, which is the chronic RfD (3.4 mg/kg/day-NOAEL) modified by an
uncertainty factor of 1000 (10X for inter-species extrapolation, 10X for
intra-species variability, and 10X FQPA safety factor for database
uncertainty- lack of a developmental neurotoxicity study).  Therefore,
the cPAD for triadimefon and triadimenol is 0.0034 mg/kg/day.  Dietary
risk results >100% of the cPAD are above the Agency’s level of
concern.    SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 The cPAD was
derived from a subchronic neurotoxicity study in rats, which accounted
for the most sensitive species and endpoints (rat versus chronic dog
study), with a LOAEL of 54.6 (male) and 68.7 (female) mg/kg/day as noted
in Table 3 above.  

			  TC "d.	Exposure Assumptions" \f C \l "4"    SEQ CHAPTER \h \r 1 a.
Dietary (Food) Risk Assessment  TC "e.	Dietary (Food) Risk Assessment"
\f C \l "4"   

The Agency conducted acute and chronic dietary exposure assessments
using the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCID, Version 2.03), which incorporates
consumption data from USDA’s Continuing Surveys of Food Intakes by
Individuals (CSFII), 1994-1996 and 1998.  

				1)	Acute Dietary Food Risk  TC "1)	Acute Dietary Risk" \f C \l "5"  

A probabilistic (Monte-Carlo) acute dietary exposure assessment was
conducted based on field trial data and 100% crop treated (%CT) at the
95th percentile.  The risk assessment combined exposure for both
triadimefon and triadimenol.  Acute dietary (food only) risk estimates
were based on field trial data for pineapples (triadimefon and
triadimenol) and bananas (triadimenol), plus seed treatment uses on
cotton and grain (barley, corn, oats, rye, sorghum, and wheat) from
triadimenol based on a tolerance level approach and assuming 100% crop
treated.  The ratio of total toxic residues (TTR) to triadimefon, from
available metabolism studies, was used to estimate the total residues of
concern.  

For food alone, acute dietary risk estimates are below the Agency’s
level of concern (<100% aPAD) at the 95th percentile exposure for
children 1-2 years old at 32% of the aPAD, the most highly exposed
population subgroup.  The 95th percentile of exposure is the appropriate
percentile to use given the level of refinement (i.e., unrefined) of the
residue values used and that 100% of the crops are assumed to be
treated.  Refer to Table 5 below.

Table 5.  Results of Acute Dietary Exposure Analysis for Food Alone
Using DEEM-FCID

Population Subgroup	

aPAD (mg/kg/day)	

95th Percentile

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  TC "2)	Chronic Dietary Risk" \f C \l
"5"  

  SEQ CHAPTER \h \r 1 	 

Chronic dietary exposure assessments were also conducted using the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID, Version 2.03), which incorporates
consumption data from USDA’s Continuing Surveys of Food Intakes by
Individuals (CSFII), 1994-1996 and 1998.  

The risk assessment combined exposure for both triadimefon and
triadimenol.  Chronic dietary (food only) risk estimates were based on
field trial data for pineapples (triadimefon and triadimenol) and
bananas (triadimenol), plus seed treatment uses on cotton and grain
(barley, corn, oats, rye, sorghum, and wheat) from triadimenol using a
tolerance level approach and assuming 100% crop treated. 

For all supported commodities, the chronic dietary exposure to
triadimefon from food (only) is below the Agency’s level of concern
(<100% cPAD) for the U.S. population (6% cPAD) and all population
subgroups, including children 1-2 years old (15% of the cPAD), the most
highly exposed subgroup.  Refer to Table 6 below.

Table 6.  Results of Chronic Dietary Exposure Analysis for Food Alone
Using DEEM-FCID

Population Subgroup	

cPAD (mg/kg/day)	

Food Alone

Exposure (mg/kg/day)	

% cPAD

General U.S. Population	

0.0034	

0.000194	6

All Infants (< 1 year old)	

0.0034	

0.000227	

7

Children 1-2 years old	

0.0034	

0.000493	

15

Children 3-5 years old	

0.0034	

0.000471	

14

Children 6-12 years old	

0.0034	

0.000323	

10

			b.	Dietary Exposure from Drinking Water  TC "1.	Dietary Risk from
Drinking Water" \f C \l "4"  

Surface Water Exposure

  TC "a.	Surface Water" \f C \l "4"  

Triadimefon and triadimenol can be transported to surface water during
or after application via run-off and/or erosion as well as soil leaching
from ground applications.  The triadimefon surface water assessment is
based on Florida turf use.  This scenario was chosen because it is
expected to present the greatest risk to drinking water supplies.
Because water monitoring data for triadimefon are limited, the Agency
used screening-level models to estimate drinking water concentrations of
triadimefon from surface water.

Since current labels do not limit the number of applications, EECs were
calculated for a range of numbers of applications for residential and
golf/sod turf.  However, Bayer, the technical registrant, is only
supporting a maximum turf rate of 2 applications of 2.7 lbs. ai/A for
golf courses and sod farms.  As a result, only those results are
presented here.  Since there is no limitation for application to tees,
greens, and/or fairways, “entire course” values (also applies to sod
farm use) were used in determining potential surface drinking water
concentration(s).  

A summary of the surface water concentration scenarios is presented
below in Table 7.  For additional information, refer to the Tier 2
Drinking Water Assessment for Triadimefon and its Major Degradate
Triadimenol, dated August 31, 2005.

Table 7.  Estimated Concentrations of Triadimefon and its Degradate
Triadimenol in Surface Drinking Water Using PRZM/EXAMS Scenarios (Turf)

Use Scenario	

Portion of Golf Course- (Treated)	Acute Concentration (ppb)	

Chronic Concentration (ppb)

	

1 in 10 year annual mean (non-cancer) (ppb)	30-year overall mean
(cancer) 

(ppb)

2 applications

14 day interval

2.75 lbs ai/A

(1 oz/1000 ft2)	

Entire Course	93.5	

19.6	

9.1

Groundwater Exposure

As an initial screen, the concentrations expected in ground water for
the use of triadimefon were estimated using the SCI-GROW model (Tier 1
Ground Water Computer Model).  In addition, groundwater monitoring
studies were supplied by the registrant, Bayer CropScience.  Although
SciGrow should typically over-estimate expected ground water
concentrations, in this case the model actually underestimated the
SciGrow predicted value in at least one instance.  A ground water
monitoring study in New Jersey, which reflected suggested turf uses,
showed a peak groundwater concentration of 25 ppb, while the SciGrow
estimate for similar usage yielded an estimate of only 3.36 ppb. 
Therefore, the potential for ground water triadimefon contamination may
be greater than supposed.  Although the ground water monitoring values
were lower than surface water modeled values, there may be an unforeseen
risk to private shallow ground water wells used for drinking water in
areas where triadimefon is applied.  This may be further exacerbated by
the fact that, unlike surface water, which is generally treated prior to
use, private well water may be used in the home with no pre-treatment. 
However, although the Agency recognizes the potential for groundwater
contamination, surface water estimates in this case are considered
protective for ground and/or drinking water contributions.  For more
information on drinking water risks and representative calculations, see
the Water Exposure/Risk Pathway section of the revised human health risk
assessment, dated February 9, 2006.

		c.	Dietary Risk from Drinking Water

Drinking water exposure to pesticides can occur through ground and
surface water contamination.  In assessing drinking water risks, EPA
considers acute (one-day) and chronic (long-term) exposure, and uses
modeling and monitoring data, if available, to estimate those exposures.
 Given the limited use patterns of triadimenol (seed treatment) and the
amount of pesticide available on a per acre basis, drinking water
exposures resulting from the use of triadimefon in both surface and
ground water are much greater.  Consequently, the Agency is using the
exposure values from the use of triadimefon in its assessments which is
protective of any drinking water exposure from the use of triadimenol.  
Estimated environmental drinking water concentrations (EDWCs) for
triadimefon were calculated using the PRZM-EXAMS model.  The assessment
also accounted for triadimenol as the primary degradate in water.  The
PRZM-EXAMS assessment considers 100% of the golf course was treated and
that the watershed was 100% golf course.  Based on these conservative
assumptions, the Agency is regulating at the 95 percentile.   The
distribution of estimated residues of triadimefon and triadimenol were
incorporated directly into the acute dietary assessment.

Triadimefon transforms into triadimenol in the natural environment,
particularly in shallow subsurface soil and is moderately mobile and
persistent.  Triadimefon on or near the soil surface or on vegetation
may be subject to runoff and/or erosion into surface water bodies used
as drinking water supplies.  Triadimefon and triadimenol may also leach
into groundwater when triadimefon is applied in areas with well-drained
soil, high rainfall (and/or irrigation) rates, and shallow water tables.
 Once it reaches groundwater, triadimenol is likely to degrade more
slowly than the parent compound.  Both parent and degradate are stable
to hydrolysis and have fairly long half-lives in soil and water.  The
Agency modeled surface drinking water values which are higher than
groundwater estimates, and are therefore protective for dietary risk
analyses.  

	

			       1)	  Acute Dietary Water Risk

The Agency believes it is appropriate to use the 95th percentile as the
level of concern (LOC) for drinking water because the drinking water
assessment is conservative.  The following factors provide the rationale
for this approach: 1) the Agency assumes that 100 percent of the
watershed is in golf courses (100 percent cropped area (PCA)), and
therefore 100% of the watershed is turf treated with triadimefon; 2)
residue estimates were modeled using PRZM-EXAMS, which usually results
in higher water concentration values than would monitoring data; 3) the
dose spacing between the NOAEL and LOAEL in the guideline acute and
subchronic neurotoxicity studies is fairly large; and 4) the entire golf
course is assumed to be treated.

  Acute dietary (water only) risk estimates were based on a FL golf
course scenario for triadimefon.  The acute dietary exposure to
triadimefon from water (only) is below the Agency’s level of concern
(<100% cPAD) for the U.S. population (24% aPAD) and all population
subgroups, including all infants (< 1 year old) (85% of the aPAD), the
most highly exposed subgroup (See Table 8).

Table 8. Results of Acute Dietary Exposure Analysis for Water (only)
Using DEEM-FCID

Population Subgroup	

aPAD (mg/kg/day)	

95th Percentile

Exposure (mg/kg/day)	

% aPAD

General U.S. Population	

0.0034	

0.000812	24

All Infants (< 1 year old)	

0.0034	

0.002904	

85

Children 1-2 years old	

0.0034	

0.001235	

36

Children 3-5 years old	

0.0034	

0.001148	

34

Children 6-12 years old	

0.0034	

0.000789	

23

2)	Chronic Dietary Water Risk	

  Chronic dietary (water only) risk estimates were based on this
scenario incorporating both triadimefon and its degradate triadimenol to
determine risk values.  The chronic dietary exposure to triadimefon from
water (only) is below the Agency’s level of concern (<100% cPAD) for
the U.S. population (12% cPAD) and all population subgroups, including
non-nursing infants (49% of the cPAD), the most highly exposed subgroup
(See Table 9).

Table 9. Results of Chronic Dietary Exposure Analysis for Water (only)
Using DEEM-FCID

Population Subgroup	

cPAD (mg/kg/day)	

95th Percentile

Exposure (mg/kg/day)	

% cPAD

General U.S. Population	

0.0034	

0.000414	12

Infants (non-nursing)	

0.0034	

0.001681	

49

Children 1-2 years old	

0.0034	

0.000615	

18

Children 3-5 years old	

0.0034	

0.000575	

17

Children 6-12 years old	

0.0034	

0.000397	

12

		5.	Residential (Non-dietary) Exposure and Risk  TC "3.	Residential
(Non-dietary) Risk" \f C \l "3"  

Triadimefon

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

Triadimenol

	There are no residential uses of triadimenol products.

	Currently, triadimefon products are marketed for homeowner use on
residential lawns, landscape ornamentals, and trees. 
Triadimefon-containing products are also marketed for use by
professional applicators (Pest Control Operators, or PCOs) on
residential turf, on golf courses, other turf such as
recreational/commercial areas, and on ornamental plantings.  Based on
these uses, triadimefon is assessed for the residential handler, and for
post-application dermal contact for adults, youths, and for toddler’s
post-application incidental oral exposure that may occur from turf
contact.  Residential exposure may occur during and after application at
homes, or after applications at golf courses, parks, schools, or other
turf sites.  Each route of exposure (oral, dermal, inhalation) is
assessed, where appropriate, and risk is expressed as a Margin of
Exposure (MOE > 1000 does not exceed the Agency’s Level of Concern). 
For more information on residential exposure and risk, refer to the
document, Triadimefon: Occupational and Residential Exposure Assessment
for the Reregistration Eligibility Decision Document, dated June 30,
2006.

Residential Handler Risk

The anticipated use patterns and current labeling indicate several
residential handler exposure scenarios based on the types of equipment
and techniques that can be used to make triadimefon applications.  The
quantitative short-term exposure/risk assessment developed for
residential handlers is based on these scenarios.  Intermediate-or
long-term exposures are not likely because of the intermittent nature of
applications by homeowners.  

(Mixer/Loader/Applicators):	

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

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

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

	(4) Wettable Powders with Hose-End Sprayer (Residential ORETF data --
liquid 	concentrate application to ornamentals)

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

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

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

Inhalation risks for residential handlers are not a concern for all
residential uses of triadimefon.  Combined dermal and inhalation risks
for residential handlers are not a concern (MOEs >1000) for the
following scenarios: 

(1) Mixing/loading/applying liquid and wettable powder formulations to
outdoor and greenhouse flowers, trees, and shrubs with a low pressure
handwand; 

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

	

However, combined risks remain a concern (MOEs < 1000) for
mixing/loading/applying liquid concentrates/ wettable powders with a
hose-end sprayer to greenhouse ornamentals.  Short-term risks for
residential handlers are presented below in Table 10, which only
represents those scenarios that exceed the Agency’s level of concern
(MOE < 1000).

Table 10.  Triadimefon Residential Handler Risks 

Exposure Scenario	

Crop or Target	

App Ratea 

(lb ai

/gallon)	

Area Treated Dailyb 

(gallons)	

Baseline Unit Exposure	

MOEs

Dermalc

(mg/lb ai)	

Inhalationd  (mg/lb ai)	

Baseline Dermal	

Baseline Inhalation	

Baseline Dermal + 

Baseline Inhalation MOE 

Mixer/Loader/Applicator

Mixing/

Loading/

Applying Liquid Concentrates with Hose-End Sprayer	Greenhouse
ornamentals (shrubs, trees)	0.00938	100	39	1.6	490	160000	490

Mixing/

Loading/

Applying Liquid Concentrates with Hose-End Sprayer	Greenhouse

ornamentals (flowering)	0.00938	100	34	0.82	560	310000	560

Mixing/

Loading/

Applying Wettable Powders with Hose-End Sprayer	Greenhouse

ornamentals (flowering)	0.00625	100	34	0.82	850	460000	850

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

b  Amount handled per day values are EPA estimates of acres, square
feet, or cubic feet treated or gallons applied based on Exposure SAC,
SOP #9 Standard Values for Daily Acres Treated in Agriculture, and
industry sources, and EPA estimates.	

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

d Baseline Inhalation: no respirator. 

				

				b.	Residential Post-application Exposure and Risks

The Agency uses the term “post-application” to describe exposures to
individuals that occur as a result of being in an environment that has
been previously treated with a pesticide.  Triadimefon can be used in
many areas that can be frequented by the general population including
residential areas (e.g., home lawns and gardens).  As a result,
individuals can be exposed by entering these areas if they have been
previously treated. 

Exposures were calculated by considering the potential sources of
exposure (e.g., dislodgeable foliar residues (DFRs) on ornamental
plants) for both triadimefon and triadimenol, then calculating dermal
and non-dietary ingestion exposures and risks.  Individuals of varying
ages can potentially be exposed to triadimefon when they are in areas
that have been previously treated.  Post-application exposure scenarios
were developed for each residential setting where triadimefon can be
used.  The scenarios that were assessed are dermal exposure to adults,
dermal exposure to youths, and dermal and incidental oral exposure to
toddlers from those uses which remain where there is a potential for
post-application exposure.

	Risk Summary: 

Risks were calculated using the Margin of Exposure (MOE) approach, which
is a ratio of the body burden to the toxicological endpoint of concern. 
Risks to adults and youths are below the Agency’s level of concern
(See Table 11 & 12 below).

Table 11.  Adult Residential Risk Estimates for Post-application
Exposure to Triadimefon (including Triadimenol)

Exposure Scenario	Route of Exposure	Formulation	Application Rate

(lb ai/acre)	MOE at Day 0

Outdoors – with default transferable residues

Home Garden (Ornamentals)	Dermal	Spray	0.25	4,800

Golfer	Dermal	Spray/Granular	1.3 (Bayer max residential)	12,000

Table 12. Youth Residential Risk Estimates for Post-application Exposure
to Triadimefon (including Triadimenol)

Exposure Scenario	Route of Exposure	Formulation	Application Rate

(lb ai/acre)	MOE at Day 0

Outdoors – with default transferable residues

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

Golfer	Dermal	Spray/Granular	1.3 (Bayer max residential)	7,800

The registrant has agreed to voluntarily cancel all residential turf use
and include a pre-transplant interval of 17 days to sod farms in order
to address any potential concerns for post-application exposure to
toddlers.  

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

		6.	Aggregate Exposure/Risk from Triadimefon and Triadimenol

The FQPA amendments to the FFDCA, section 408(b)(2)(A)(ii)) require the
Agency to determine “that there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and other exposures for
which there is reliable information.”  Aggregate exposure will
typically include exposures from food, drinking water, residential uses
of a pesticide, and other non-occupational sources of exposure.  When
aggregating exposure and risk from various sources, the Agency considers
the route and duration of exposure.  

Acute (Food and Water) 

	The Agency believes it is appropriate to use the 95th percentile as the
level of concern (LOC) for the entire golf course because it is a highly
conservative approach.  The following factors provide the rationale for
this approach: 1) the Agency assumes that 100 percent of the watershed
is in golf courses (100 percent cropped area (PCA)), and therefore 100%
of the watershed is turf treated with triadimefon; 2) residue estimates
were modeled using PRZM-EXAMS, which usually results in higher water
concentration values than would monitoring data; 3) the dose spacing
between the NOAEL and LOAEL in the guideline acute and subchronic
neurotoxicity studies for triadimefon are fairly large; and 4) the
Agency assumes that the entire golf course is treated.

	Combined acute dietary (food and water) risk estimates from pineapples
(triadimefon) and drinking water (triadimefon from golf course
application to entire golf course) plus seed treatment uses and banana
import tolerance (triadimenol) are below the Agency’s level of concern
(<100% aPAD) at the 95th percentile of exposure (assuming 2 applications
per year for turf at 2.7 lbs ai/A).  The dietary exposure for acute food
and drinking water is 33% of the aPAD for the U.S. population and 94% of
the aPAD for all infants less than one year old, the most highly exposed
population subgroup.  A summary of acute dietary risk estimates (food +
drinking water) is presented below in Table 13.

Table 13.  Triadimefon and Triadimenol Results of Acute Dietary Exposure
Analysis for Food + Drinking Water From the Golf Course (entire) Use
Scenario Using DEEM-FCID

Population Subgroup	

aPAD (mg/kg/day)	

95th Percentile

Exposure (mg/kg/day)	

% aPAD

General U.S. Population	

0.0034	

0.001106	33

All Infants (< 1 year old)	

0.0034	

0.003190	

94

Children 1-2 years old	

0.0034	

0.001959	58

Children 3-5 years old	

0.0034	

0.001765	

52

Children 6-12 years old	

0.0034	

0.001210	

36

Chronic (Food and Water)

	Combined chronic dietary (food and water) risk estimates were derived
from pineapples and drinking water (entire golf course-triadimefon) plus
seed treatment uses and bananas import tolerance from triadimenol. 
Drinking water exposures are based on using the 1 in 10 year annual mean
concentration assuming 2 applications per year for turf at 2.7 lbs ai/A.
 The dietary exposure for chronic food and drinking water is below the
Agency’s level of concern and is 18% of the cPAD for the U.S.
population and 57% of the cPAD for non-nursing infants, the most highly
exposed population subgroup.  A summary of chronic dietary risk
estimates (food + drinking water) is presented below in Table 14.

Table 14.  Triadimefon Results of Chronic Dietary Exposure Analysis for
Food + Drinking Water From the Golf Course (entire) Using DEEM-FCID

Population Subgroup	

cPAD (mg/kg/day)	

95th Percentile

Exposure (mg/kg/day)	

% cPAD

General U.S. Population	

0.0034	

0.000607	18

Infants (non-nursing)	

0.0034	

0.001952	

57

Children 1-2 years old	

0.0034	

0.001108	33

Children 3-5 years old	

0.0034	

0.001047	

31

Children 6-12 years old	

0.0034	

0.000720	

21

Short-term (Food + Water + Residential)

	The exposure attributable to residential uses of triadimefon were not
initially aggregated with dietary sources of exposure (food plus
drinking water) because at that time the dietary and residential
exposure pathways separately exceeded the Agency’s level of concern. 
The registrant agreed to voluntarily delete residential turf uses and
all food uses (except pineapple) so that the aggregate risks are within
acceptable levels.  Taking into consideration the agreement to request
deletion of these uses and mitigation requiring a 17-day
post-application, pre-transplant interval for sod farms, risks will be
below the Agency’s level of concern.

	Aggregate exposures to toddlers, youths, and adults could occur from
triadimefon uses on golf courses and in residential settings from turf
transplanted from sod farms.  The Agency assessed short-term aggregate
risks to adults and toddlers by calculating an aggregate risk MOE
assuming background (chronic) exposure to triadimefon and triadimenol
residues from dietary (food and water) sources.  The chronic exposure
from drinking water considers treatment of an entire golf course. 
Short-term aggregate risk, calculated as an MOE, is 1100 for toddlers
(from the turf use), and 1300 for adults and for youths (from the golf
course use).  None of these estimates exceed the Agency’s level of
concern.

	Aggregate exposures could also occur for adults making applications to
residential ornamentals.  Using this scenario and assuming an
application rate of 0.005 to 0.0025 lb. ai/gallon with the highest
exposure scenario that is still below the Agency’s level of concern
(mixing/loading/applying wettable powders with a low pressure handwand
to greenhouse ornamentals), aggregate (food + water + residential) risk
is below the Agency’s level of concern (MOE = 1300).

	The combined risk assessment for exposures to toddlers following the
application of sod farm turf transplanted to a residential lawn are not
a concern (MOEs > 1000) at day 17 following application to sod farms at
the 2.7 lbs ai/A rate.  Therefore, the labels for these products must be
restricted to not allow transplantation earlier than the 17th day after
treatment.

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

	Intermediate-term and chronic residential exposures to triadimefon are
not expected because of the intermittent nature of applications in
residential settings.  Therefore, intermediate-term chronic aggregate
risk assessments were not conducted.

	7.	Pesticide and Pharmaceutical Co-Exposure Assessment for 

The Triazole Metabolites

FFDCA Section 408 requires EPA to consider potential sources of exposure
to a pesticide and related substances in addition to the dietary sources
expected to result from a pesticide use subject to a tolerance (legal
limit for pesticide residue levels) in food or feed commodities.  In
determining whether to maintain a pesticide tolerance, EPA must
“determine that there is a reasonable certainty of no harm…” in
accordance with FFDCA, Section 408(b)(2)(A)(ii).  The FDA regulates
human drugs for safety and effectiveness under FFDCA section 505 and may
approve use of a drug in humans notwithstanding the possibility that
some individual patients may experience adverse side effects.  EPA does
not believe that, for purposes of the section 408 dietary risk
assessment, it is compelled to treat a pharmaceutical patient the same
as a non-patient, or to assume that combined exposures to pesticide and
pharmaceutical residues that lead to a physiological effect in the
patient constitutes “harm” under the meaning of section 408 of the
FFDCA. 

Rather, EPA believes that an appropriate way to consider the metabolite
1,2,4-triazole resulting from pharmaceutical use of triazole-derivative
drugs would be to consider the additional contribution that
non-occupational pesticide exposure would have to a pharmaceutical
patient exposed to the same compound.  Where the additional pesticide
exposure has no more than a minimal impact on the pharmaceutical
patient, EPA can make a “reasonable certainty of no harm” finding
for the pesticide tolerances of that compound under FFDCA Section 408. 
If the potential impact on the pharmaceutical user as a result of
co-exposure from pesticide use is more than minimal, then EPA would not
be able to conclude that dietary residues were safe, and would need to
discuss with FDA appropriate measures to reduce exposure from one or
both sources.  

As previously mentioned, triadimefon may share a common metabolite,
1,2,4-triazole, with triazole-derivative pharmaceutical compounds. 
Thus, EPA consulted with FDA on triazole drugs that could metabolize to
1,2,4-triazole and the Agencies concluded that only one compound,
anastrozole, a chemotherapy drug used to treat breast cancer, had this
metabolic pathway in humans.  Because anastrozole is used at very small
doses in a limited population of patients, EPA conducted a conservative
screening-level assessment to determine whether the combined metabolites
from triazole pesticide uses and anastrozole would adversely impact
pharmaceutical users.  EPA concluded that, using upper-bound estimates
for metabolites of anastrozole, the combined metabolite exposure is
below the Agency’s level of concern.  Because EPA is able to reach
this conclusion with a screening-level assessment, the Agency has not
conducted a more refined co-exposure assessment for pharmaceutical uses
as described above.  Therefore, EPA concludes that the potential dietary
pesticide exposure to triazole pesticide residues in food and water will
result in no harm to a patient being treated with anastrozole.  Please
see the May 19, 2006, memo from FDA and the July 18, 2006, EPA document
summarizing EPA and FDA discussions on potential free triazole
metabolites of triazole derivative drugs, (both available in the public
docket for triadimefon, EPA-HQ-OPP-2005-0258) for additional
information.  

  	 	8.	Cumulative Risk Assessment  TC "5.	Cumulative Risk Assessment"
\f C \l "3"  

  SEQ CHAPTER \h \r 1 Section 408(b)(2)(D)(v) of the FFDCA requires
that, when considering whether to establish, modify, or revoke a
tolerance, the Agency consider “available information” concerning
the cumulative effects of a particular pesticide’s residues and
“other substances that have a common mechanism of toxicity.”  Other
substances are considered to account for the possibility that low-level
exposures to multiple chemical substances that cause a common effect by
a common mechanism could lead to the same adverse health effect as would
a higher level of exposure to each individual substance.  For the
purposes of this reregistration eligibility decision, EPA has concluded
that triadimefon and triadimenol do not share a common mechanism of
toxicity with other substances.  The Agency reached this conclusion
after a thorough internal review and external review of the data
supporting a common mechanism of toxicity for a number of chemical
classes.  Triadimefon, triadimenol, and the other triazole fungicides
share the common metabolites 1,2,4-triazole, triazole alanine, and
triazole acetic acid, which are considered in this RED.

		9.	Occupational Risk  TC "6.	Occupational Risk" \f C \l "3"  

The registrant has agreed to voluntarily delete all uses on apples,
pears, grapes, raspberries, and residential turf.  Occupational
post-application exposure and risk assessment for agricultural uses of
triadimefon indicates that risks are not a concern at day 0 (i.e., 12
hours after application) for all use sites and all post-application
activities.

  SEQ CHAPTER \h \r 1 Workers can be exposed to a pesticide through
various routes/pathways.  There is potential for exposure to triadimefon
in occupational scenarios from handling triadimefon products during the
application process (i.e., mixer/loaders, applicators, flaggers, and
mixer/loader/applicators), and a potential for post-application worker
exposure from entering into areas previously treated with triadimefon. 
In addition, there is potential exposure to workers who treat seed with
triadimefon in commercial and nursery settings and to persons who plant
treated seed.  Occupational risk for all of these potentially exposed
populations is measured by a MOE, which determines how close the
occupational exposure comes to a dose level or NOAEL.

Occupational risk is assessed for exposure at the time of application
(termed “handler” exposure) and following application (termed
post-application exposure).  Application parameters are generally
defined by the physical nature of the formulation (e.g., formula and
packaging), by the equipment required to deliver the chemical to the use
site, and by the application rate required to achieve an efficacious
dose.  Post-application risk is assessed for activities such as
scouting, irrigating, pruning, and harvesting, and is based primarily on
dermal exposure estimates.  Note that occupational risk estimates are
intended to represent pesticide workers, and on this basis assumptions
are made concerning acres treated per day and the seasonal duration of
exposure.

Triadimenol is only being reviewed for tolerance reassessment purposes. 
Currently registered uses do not involve occupational exposures. 
Therefore, no worker risk assessment was completed.

For more information on the assumptions and calculations of potential
risk of triadimefon to workers, refer to the documents entitled:
Triadimefon. Occupational and Residential Exposure Assessment for the
Reregistration Eligibility Decision Document, dated June 30, 2006; and
the memorandum: Triadimefon/Triadimenol: Summary of Refinements and
Revisions to the Human Health Risk Assessment, dated July 10, 2006.

			a.	Occupational Toxicity  TC "a.	Occupational Toxicity" \f C \l "4"  

  SEQ CHAPTER \h \r 1 Table 15 below provides a listing of the
toxicological endpoints used in the triadimefon occupational risk
assessment.

Table 15.  Toxicological Endpoints for the Triadimefon Occupational Risk
Assessment

Exposure

Scenario	

Dose Used in Risk Assessment, UF 	

Level of Concern for Risk Assessment	

Study and Toxicological Effects

Dermal 

Short-Term

(1 - 30 days)	Dermal NOAEL = 300 mg/kg/day 

   UF = 100	

Occupational

MOE = 100	21 day dermal toxicity in rabbits.

The LOAEL= 1000 mg/kg/day based on increased reactivity and activity in
the females. 

Dermal 

Intermediate-Term

(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 

Intermediate-Term

(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. 

			b.	Occupational Handler Exposure  TC "b.	Occupational Handler
Exposure" \f C \l "4"  

  SEQ CHAPTER \h \r 1 Occupational handler risk estimates have been
assessed for both short- and intermediate-term exposure durations.  Due
to the use patterns for triadimefon, long-term exposures are not
expected.  Since the endpoints and points of departure (PODs) are
identical to assess short and intermediate exposure, these risk
estimates represent both durations of exposure.

Occupational handler assessments are conducted using increasing levels
of protection.  The Agency typically evaluates all exposures with
minimal protection and then considers additional protective measures
using a tiered approach in an attempt to obtain an adequate MOE.  The
lowest tier is represented by the baseline clothing scenario (i.e.,
single layer clothing, socks, and shoes), followed by increasing levels
of risk mitigation such as personal protective equipment (PPE) and
engineering controls (EC).  In the case of triadimefon, exposure to
pesticide handlers is likely during the occupational use of the
pesticide in a variety of occupational environments.  The anticipated
use patterns and current labeling indicate several occupational exposure
scenarios based on the types of equipment and techniques that can
potentially be used for triadimefon applications. Based on the use
patterns, twenty-seven major occupational handler exposure scenarios
(non-seed treatment) were identified.  In addition, six major exposure
scenarios were identified for pine seed treatment.  The following
exposure scenarios were used to develop the risk assessment for
occupational handlers.  

(Non-seed treatment)

	Mixer/Loaders:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

	

	Applicators:

	(5) Aerial Spray Applications (PHED)

	(6) Aerial Granular Applications (PHED)

	(7) Groundboom Spray Applications (PHED)

	(8) Airblast Spray Applications (PHED)

	(9) Handgun Spray Applications (PHED)

	(10) Rights of Way Spray Applications (PHED)

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

		

	Flaggers:

	(12) Flagging for Aerial Spray Applications (PHED)

	(13) Flagging for Aerial Granular Applications (PHED)

		

	Mixer/Loader/Applicators:	

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

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

(16) Water Dispersible Granules with Low Pressure Handwand (using ORETF
data for liquid formulations as a surrogate)

	(17) Liquid Formulations: Handgun Sprayer (ORETF)

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

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

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

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

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

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

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

	(25) RTU: Briquette (no data)

	(26) Liquid Formulations: Dip (no data)

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

	

	(Pine seed treatment) 

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

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

(S-3) on-nursery loading/applying wettable powders using cement mixer
equipment (using PHED mixing/loading WP data),

(S-4) on-nursery loading/applying dry flowables using cement mixer
equipment (using PHED mixing/loading DF data), 

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

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

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

(S-8) bagging and otherwise handling treated seeds with commercial
equipment, and

(S-9) multiple commercial seed treatment activities.

			c.	Occupational Handler Risk Summary  TC "c.	Occupational Handler
Risk Summary" \f C \l "4"  

  SEQ CHAPTER \h \r 1 The Agency has determined that there are potential
exposures to individuals who mix, load, apply, and otherwise handle
triadimefon during the usual use patterns associated with the
pesticide’s use.  

In all non-seed treatment scenarios, combined dermal and inhalation MOEs
meet or exceed the level of concern of 100 at some level of risk
mitigation (personal protective equipment or engineering controls).  In
the majority of scenarios where data are available, combined dermal and
inhalation risks are not a concern at baseline (long-sleeve shirt, long
pants, shoes, socks, no respirator) or baseline plus chemical-resistant
gloves.  However, there are risk concerns requiring additional dermal or
inhalation protection (e.g. a respirator or engineering controls) for
several of the scenarios involving mixing/loading/applying wettable
powder (See Table 16).

	In all the in-nursery seed treatment scenarios where data are
available, combined dermal and inhalation MOEs meet or exceed the
required level of concern of 100 at baseline or baseline plus
chemical-resistant gloves.  For commercial seed treatment, combined
dermal and inhalation risks meet or exceed the required MOE of 100 with
baseline PPE.

Table 16.  Combined Dermal plus Inhalation Handler Risks for
Agricultural and Commercial Uses 

Exposure Scenario	Crop or Target	App Rate (lb ai/acre)a	Area Treated
Daily (acre)b	Combined MOEsi

Baselinec Dermal + Baseline Inh	Single layer w/

glovesd Dermal + Baseline Inh	Double layer w/ glovese Dermal + Baseline
Inh	Single layer w/gloves  Dermal + 80% Rf Inh	Single layer w/ gloves
Dermal + 90% Rg Inh	Double layer w/ gloves Dermal + 80% R Inh	Double
layer w/ gloves Dermal + 90% R Inh	Eng Controlh Dermal + Inh

Mixer/Loader

Mixing/Loading Liquid Concentrates for Injection	ornamentals (shade
trees, woody shrubs)	0.000026 lb ai/inch of trunk	inch of trunk	No Data 
No Data 	No Data 	No Data 	No Data 	No Data 	No Data 	No Data

Mixing/Loading Wettable Powders for Aerial Applications	 Christmas trees
0.25	350	30	60	61	250

	turf (sod farm)	2.7 (except CA)	350	2.7 	5.6	5.6	23	38	24	42	680

	pine seedlings	0.5	350	15	30	30	130

Mixing/Loading Wettable Powders for Chemigation Applications	turf (sod
farm)	2.7 (except CA)	350	2.7	5.6	5.6	23	38	24	42	680

Mixing/Loading Wettable Powders for 

Groundboom Applications	azaleas	0.005 lb ai/gallon	16000

gallons	32	66	67	270

	turf (sod farm)	2.7	80	12	24	25	100

	turf (golf course)	2.7	40	24	49	49	200

Mixing/Loading Wettable Powders to Support Rights-of-way sprayer	turf
(golf course and sod farms)	2.7	80	12	24	25	100

Applicator

Applying Sprays via Aerial Equipment	Christmas trees	0.25	350	No Data	No
Data 	No Data 	No Data 	No Data 	No Data 	No Data 	20000

	turf (sod farm)	2.7	350	No Data	No Data 	No Data 	No Data 	No Data 	No
Data 	No Data 	1900

	pine seedlings	0.5	350	No Data	No Data 	No Data 	No Data 	No Data 	No
Data 	No Data 	10000

Applying Granulars via Aerial Equipment	turf (sod farm)	2.6	350	No Data
No Data 	No Data 	No Data 	No Data 	No Data 	No Data 	200

Mixer/Loader/Applicator

Mixing/Loading/Applying Wettable Powders with Low Pressure Handwand
(PHED)	turf (golf course, sod farms)	2.7	5	No Data 	15	15	53	79	58	92
Not Feasible 

	pine seedlings	0.5	5	No Data 	78	81	290

Not Feasible 

Mixing/Loading/Applying Liquids with an Injector	ornamentals (shade
trees, woody shrubs)	0.000075 lb ai/1 inch of trunk circumference	inch
of trunk circumference	No Data	No Data 	No Data 	No Data 	No Data 	No
Data 	No Data 	Not Feasible 

Mixing/Loading/Applying RTU Briquette	pine seedlings	0.00019 lb
ai/seedling	seedlings	No Data	No Data 	No Data 	No Data 	No Data 	No
Data 	No Data 	Not Feasible 

Mixing/Loading/Applying Dip	pine seed (nurseries)	0.0000625 lb ai/gallon
100 gallons	No Data	No Data	No Data	No Data	No Data	No Data 	No Data 	No
Data

	pineapple (post-harvest)	0.0028 lb ai/gallon	100 gallons	No Data	No
Data	No Data	No Data	No Data	No Data 	No Data 	No Data

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

b	Amount handled per day values are HED estimates of acres treated per
day based on Exposure SAC SOP #9 “Standard Values for Daily Acres
Treated in Agriculture,” industry sources, and HED estimates.		

c	Baseline = No gloves and no respirator (i.e., long sleeve shirt, long
pants, shoes and socks.

d	Single layer w/gloves  is baseline attire plus chemical-resistant
gloves.

e	Double layer w/gloves is coveralls worn over long-sleeve shirt and
long pants, plus chemical-resistant gloves (with headgear).  

f	80% Respirator is quarter-face dust/mist respirator (that provides an
80% protection factor).

g	90% Respirator is half-face dust/mist respirator (that provides a 90%
protection factor).

h	Engineering control is closed mixing/loading system, enclosed cab, or
enclosed cockpit.	

i	Combined MOEs =1/[(1/Dermal MOE) + (/Inhalation MOE)]As noted above,
there are no available data to assess the following: 1) mixing/loading/
applying liquids with a tree injector to ornamental trees and woody
shrubs; 2) mixing/loading/applying dips to pineapples (pre-plant and
post-harvest) and pine seed (nursery applications); 3)
drying/raking/bagging treated pine seed; and 4) ready-to-use (RTU)
briquette applications to pine seedlings.  Therefore, the Agency is
requiring the use of gloves to mitigate potential dermal exposure for
these uses described above.

			d.	Occupational Post-application Risk Summary  TC "d.	Occupational
Postapplication Risk Summary" \f C \l "4"  

  SEQ CHAPTER \h \r 1 Triadimefon is currently labeled for use on
grapes, turf (including residential, golf course and sod farm turf),
ornamentals, apples, pears, Christmas trees, pine seedlings, and
raspberries.  Because of the use pattern, a wide array of individuals
can potentially be exposed by working in areas that have been previously
treated.  However, the registrant has agreed to voluntarily delete all
uses on apples, pears, grapes, raspberries, and residential turf.  SEQ
CHAPTER \h \r 1 

The Agency has used the most up-to-date information available to
complete the post-application risk assessment for triadimefon.  Several
data gaps exist, such as a lack of triadimefon-specific post-application
studies and lack of transfer coefficients for certain crop activities. 
However, the existing database is adequate to assess post-application
risk.

Occupational risks were calculated using a MOE, which is a ratio of the
daily dose to the toxicological endpoint of concern.  Post-application
risks diminish over time because triadimefon residues eventually
dissipate in the environment.  Therefore, risks were calculated over
time based on changing residue levels.  Occupational post-application
exposure and risk assessment for agricultural uses of triadimefon
indicates that risks are not a concern at day 0 (i.e., 12 hours after
application) for all use sites and all post-application activities. 
MOEs for occupational post-application risk range from 220 for
transplanting, weeding (hand), harvesting (hand), and harvesting
(mechanical) at the 2.7 lbs. ai/A rate on sod farms and golf course
turf.

		10.	Human Incident Data

	  SEQ CHAPTER \h \r 1 In evaluating incidents to humans, the Agency
reviewed reports from the National Poison Control Centers (PCC),
California Department of Pesticide Regulation (CDPR), the Agency’s
Office of Pesticide Program’s Incident Data System (IDS), the National
Pesticide Information Center (NPIC), the National Institute of
Occupational Safety and Health’s Sentinel Event Notification System
for Occupational Risks (NIOSH SENSOR) for poisoning incident data on
triadimefon/triadimenol.  

	Data provided by the PCC reported nine incidents of occupational
exposure to triadimefon and 46 non-occupational exposures from 1993
through 2003.  Of the 46 non-occupational exposures, 13 occurred in
children under six years of age.  Of the total 20 cases with medically
determined outcome, 11 reported minor medical outcome.  From a total of
55 exposures to triadimefon, just four were seen in a health care
facility and none required hospitalization.  A review of symptoms
revealed almost exclusively irritation effects (including rash and
erythema) to skin, mouth, throat, and eyes.  In addition, there were
four cases reporting headache and two reported cough.  No other
significant symptoms were reported.

	The majority of triadimefon incidents (92%) reported by CDPR occurred
prior to 1990.  Most of the triadimefon cases (73%) involved use on
grapes which is a labor intensive crop involving high exposure to foliar
residues.  Foliar residues accounted for half of the illnesses and
nearly half of the systemic illnesses.  Skin, eye irritation, and rash
were among the most common topical symptoms.  The most common systemic
effects included nausea, headache, sneezing, congestion, difficulty
breathing and other allergic-type reactions.  In addition, there were
three reports of vomiting.  Furthermore, the registrant has voluntarily
agreed to delete all food (apples, grapes, pears, and raspberries) uses.

	Reports submitted to the IDS indicate incidents from various sources. 
The NPIC is a toll-free information service supported by OPP.  A ranking
of the top 200 active ingredients for which telephone calls were
received during calendar years 1984-1991, inclusive has been prepared. 
The total number of calls was tabulated for the categories human
incidents, animal incidents, calls for information, and others. 
Triadimefon was not reported on the list of the top 200 chemicals with
incidents reported to NPIC.  Triadimefon was associated with one case
out of a total of 5,899 cases reported to NIOSH SENSOR between 1998 and
2003.  However, this case was a duplicate of a CDPR case, which had
already been reported. 

	Conclusion: Both California and Poison Control Center data show a
pattern of irritative, but usually minor, symptoms from exposure to
triadimefon.  Irritation to skin, eyes, and respiratory passage occur
readily among unprotected handlers (applicators and mixer/loaders) and
among those who have substantial contact with foliage such as grape
harvesters and tenders.  Additionally, it should be noted that
triadimefon is a skin sensitizer, and as such, may contribute to
allergic-type reactions.  Furthermore, the registrant has voluntarily
agreed to delete all uses on apples, grapes, pears, and raspberries.

B.	Environmental Fate and Effects Risk Assessment  TC "B.	Environmental
Risk Assessment" \f C \l "2"  

Triadimefon has the following registered uses, which result in
environmental exposures: applications to fruits (apples, grapes, pears,
and raspberries) turf, pine seedlings, Christmas trees, and ornamentals.
 However, the registrant has agreed to voluntarily delete all use on
apples, grapes, pears, raspberries, and residential turf.  SEQ CHAPTER
\h \r 1   A summary of the Agency’s environmental risk assessment for
triadimefon is presented below.  More detailed information associated
with the environmental risk from the use of triadimefon can be found in
the   SEQ CHAPTER \h \r 1 Environmental Fate and Ecological Risk
Assessment (Revised) for Triadimefon, dated January 19, 2006 and
Response to Bayer Public Comments Regarding the Environmental Fate and
Effects Division Triadimefon Risk Assessment, dated June 1, 2006.  These
documents may be accessed in the OPP Public Docket (docket number
EPA-HQ-OPP-2005-0258) at   HYPERLINK "http://www.regulations.gov" 
http://www.regulations.gov .  

		1.	Environmental Fate and Transport  TC "a.	Environmental Fate and
Transport" \f C \l "4"  

Triadimefon is stable to hydrolysis but degrades by photolysis in water
with a half-life of 7.6 hours.  In aerobic sandy loam soil, parent
triadimefon degraded with a half life of 5.6 days, and in anaerobic
sandy loam soil the half life was 23.1 days.  In anaerobic aquatic
environments, triadimefon had a half-life of 217 days.  The primary
degradate identified in environmental fate studies (aerobic/anaerobic
soil and anaerobic aquatic) was triadimenol.  The other degradates
identified in these studies were: p-chlorophenol (photolysis
water/soil), 4-chlorophenoxy-1,2,4-triazol-1-yl-methane (aerobic soil),
and 1H-1,2,4-triazole (aerobic soil).  

The environmental fate assessment was based on an evaluation of total
triadimefon toxic residues, which includes both parent and the degradate
triadimenol.  Since approximately 75% of parent triadimefon degraded to
triadimenol within 60 days post-application, for the purpose of
modeling, physical characteristics that reflected combined properties of
both compounds in proper relative proportions were used.  Thus, for
example, the aerobic soil half-life for total residues used in modeling
was 240 days.

Both triadimefon and triadimenol were shown to be moderately soluble,
and are therefore capable of being transported dissolved in water as
surface runoff or as leachate to groundwater.  The adsorption
coefficients (Koc) for triadimefon and triadimenol were 387 L/kgoc and
365 L/kgoc (average of four soils), respectively.  Triadimenol appears
to be even more prone to leaching than triadimefon.  This may be due
partly to its formation in the aerobic subsurface, where subsequent rain
or irrigation events can leach it deeper into the soil.  However, due to
its moderate mobility and adsorption characteristics, triadimefon is
capable of persisting and accumulating in a variety of environmental
conditions.  Therefore, triadimefon is likely to be of greater concern
for surface water runoff issues, but triadimenol is of greater concern
for groundwater and apt to be more persistent than parent triadimefon in
most settings.

	2.	Ecological Exposure and Risk  TC "b.	Aquatic Organism Exposure" \f C
\l "4"  

	To estimate potential ecological risk, EPA integrates the results of
exposure and ecotoxicity studies using the risk quotient method.  Risk
quotients (RQs) are calculated by dividing estimated environmental
concentrations (EECs), based on environmental fate characteristics and
pesticide use data, by ecotoxicity values for various wildlife and plant
species.  RQs are then compared to levels of concern (LOCs), and when
the RQ exceeds the level of concern for a particular category, the
Agency presumes a risk of concern to that category.   See Table 17 for
the Agency’s LOCs.  Risk characterization provides further information
on potential adverse effects and the possible impact of those effects by
considering the fate of the chemical and its degradates in the
environment, organisms potentially at risk, and the nature of the
effects observed.  To the extent feasible, the Agency seeks to reduce
environmental concentrations in an effort to reduce the potential for
adverse effects to non-target organisms.  

Table 17.  EPA’s Levels of Concern and Associated Risk Presumptions

  SEQ CHAPTER \h \r 1 Risk Presumption	LOC

Terrestrial Animals	LOC 

Aquatic Animals	LOC

Plants (Terrestrial/ Aquatic/Semi-Aquatic) 

Acute Risk - there is potential for acute risk.	0.5	0.5	1

Acute Endangered Species - endangered species may be adversely affected.
0.1	0.05	1

Chronic Risk - there is potential for chronic risk.	1	1	N/A

For a more detailed explanation of the ecological risks posed by the use
of triadimefon, refer to the “  SEQ CHAPTER \h \r 1 Environmental Fate
and Effects Division Revised Risk Assessment for Triadimefon”, dated
January 19, 2006.

Aquatic Organism Exposure and Risk

	

	1)	Fish, Invertebrate, and Aquatic Plant Toxicity

Freshwater and Estuarine/Marine Fish

Toxicity studies conducted using technical triadimefon demonstrate that
it is slightly to moderately toxic to freshwater fish under acute
exposure with LC50 values ranging from 4.1 ppm to 28 ppm (rainbow trout)
and 10 ppm to 24.7 ppm (bluegill sunfish).   Likewise, two freshwater
toxicity studies were also conducted for the major triadimefon
degradate, triadimenol.  The freshwater fish acute toxicity values
(LC50) for triadimenol indicate that triadimenol is slightly toxic on an
acute basis.  

Tables 18 and 19 summarize the data that support the acute toxicity
endpoints used in assessing the risks to freshwater fish.  No
triadimefon or triadimenol estuarine/marine fish acute toxicity tests
were submitted to the Agency.  

Table 18.  Acute Toxicity Endpoints for Freshwater Fish (Triadimefon)

Test Species/

	% a.i.	96-hr LC50 (ppm)	Toxicity

Classification	MRID No. Author/Year 

Cold water fish (Rainbow trout, Oncorhynchus mykiss	96.8	4.1	

Moderately toxic	43256201

Bowers/1994

Table 19.  Acute Toxicity Endpoints for Freshwater Fish (Triadimenol)

Test Species/

	% a.i.	96-hr LC50 (ppm)	Toxicity

Classification	MRID No. Author/Year 

Warm water fish

(Bluegill sunfish, Lepomis macrochirus)	92	14	

Slightly toxic	071469

Lamb/1981

For chronic toxicity, a freshwater fish early life-stage test using
technical triadimefon showed that the most sensitive species is the
rainbow trout, with a NOAEL of 41 ppb (0.041 ppm).  However, no chronic
freshwater fish toxicity data were available for the degradate
triadimenol.  In addition, no triadimefon or triadimenol
estuarine/marine fish chronic toxicity tests were submitted.  Table 20
summarizes the data for the chronic toxicity endpoints used in assessing
the risks to freshwater fish.  

Table 20.  Early Life-Stage Chronic Toxicity Endpoints for Freshwater
Fish 

(Triadimefon)  

Group

(Test Species)

	% a.i.	NOAEL (ppm)	LOAEL

(ppm)	Endpoints Affected	MRID No. Author/Year 

Cold water fish

(Rainbow trout, Oncorhynchus mykiss)	93	0.041	

0.116

	Growth	251243

Carlisle/1983

Freshwater and Estuarine/Marine Invertebrates 

Toxicity studies conducted using technical triadimefon demonstrate that
it is slightly to moderately acutely toxic to freshwater invertebrates,
with LC50 values ranging from 1.6 to 11.3 ppm.  Freshwater invertebrate
acute toxicity tests were also performed for the degradate triadimenol,
resulting in an LC50 value of 2.5 ppm (moderately toxic).  Table 21
summarizes the data that support the acute toxicity endpoints used in
assessing the risks to aquatic invertebrates.  No triadimefon or
triadimenol estuarine/marine invertebrate acute toxicity tests were
submitted to the Agency.  

Table 21.  Acute Toxicity Endpoints for Freshwater Invertebrates 

Test Species/ Flow-through	% a.i.	48-hr LC50 (ppm)	Toxicity

Classification	MRID No. 

Author/Year

Triadimefon

Invertebrate (Waterflea, Daphnia magna)	Tech.	1.6	Moderately toxic
231311

Lamb/1997

Triadimenol

Invertebrate (Waterflea, Daphnia magna)	92	2.5	Moderately toxic	071469

Lamb/1981

A freshwater early life stage aquatic toxicity test using technical
triadimefon is available for daphnia magna with a NOAEL of 0.052 ppm
(decreased adult length).  Table 22 summarizes the data for the chronic
toxicity endpoint used in assessing the risks to freshwater
invertebrates.  No triadimenol freshwater invertebrate chronic toxicity
data was submitted, and no triadimefon or triadimenol estuarine/marine
invertebrate chronic toxicity tests were submitted.

Table 22.  Early Life-Stage Chronic Toxicity Endpoints for Freshwater
Invertebrates 

Group

(Test Species)

	% a.i.	NOAEL (ppm)	LOAEL

(ppm)	Endpoints Affected	MRID No. Author/Year 

Triadimefon

Invertebrate (Waterflea, Daphnia magna)	94.2	0.052	

0.119

	

Adult length	41922102

Gagliano/1991

Non-target Aquatic Plants

An aquatic plant toxicity study was performed for triadimefon on the
technical formulated product on green algae, resulting in an EC50 value
of 1.71 ppm.  The EC50 value for triadimenol was 3.7 ppm.  No studies
were performed on vascular aquatic plant species.  Table 23 summarizes
the data for the plant toxicity endpoints used in assessing the risks to
aquatic plants.  

Table 23.  Toxicity Endpoints for Aquatic Plants (Nonvascular)

Species	% a.i.	EC50 

(ppm)	EC05 or NOAEC (ppm)	MRID No. 

Author/Year

Triadimefon

Green algae

Scenedesmus subspicatus	91.5	1.71	0.1	00159558

Heimbach/1985

Triadimenol

Green algae

Scenedesmus subspicatus	94.9	3.7	0.32	266051

Mobay/1986

2)	Fish and Invertebrate Exposure

	This assessment assumes exposure to both the parent triadimefon as well
as triadimenol for aquatic organisms.  OPP generally uses computer
simulation models to estimate exposure of aquatic organisms, such as
plants, fish, aquatic-phase amphibians, and invertebrates, to a
pesticide.  These models calculate estimated environmental
concentrations (EECs) in surface water using laboratory data that
describe the rate at which the pesticide breaks down and how it moves
into the environment.  The Pesticide Root Zone Model and Exposure
Analysis Modeling System (PRZM-EXAMS) model is initially used to
calculate high-end estimates of surface water concentrations of
pesticide in a generic pond.  This model was used to generate EECs of
total triadimefon (parent + triadimenol) in surface water.  The User’s
Manual and PRZM-EXAMS model description can be consulted for additional
information at: www.epa.gov/offefed1/models/water/index.htm.  No EECs
are generated in instances where no toxicity was observed at
concentrations above the active ingredient’s water solubility or at or
above the recommended limit concentration for a particular type of
study.

The Agency used PRZM-EXAMS (Exposure Analysis Modeling System) modeling
to derive tier II estimated environmental concentrations (EECs) for
triadimefon in surface water.  Unlike the drinking water assessment
described in the human health risk assessment section of this document,
the ecological water resource assessment does not include the Index
Reservoir (IR) and Percent-Crop Area (PCA) factor refinements.  The IR
and PCA factors represent a drinking water reservoir, not the variety of
aquatic habitats, such as ponds adjacent to treated fields, relevant to
a risk assessment for aquatic animals.  The assumptions used represent
pesticide transport in surface water in a standard pond (10,000-m2 pond,
2-m deep), with the assumption that the small field (10-ha agricultural
field) is cropped at 100%. Therefore, the EEC values used to assess
exposure to aquatic organisms are not the same as the values used to
assess human dietary exposure from drinking water sources.  

	Several scenarios chosen to represent different U.S. regions and uses
were modeled for each use and can be found in the environmental fate and
effects assessment for triadimefon.  The turf scenarios gave the maximum
EECs, and so were chosen for regulatory purposes.  The EEC values used
to assess exposure to aquatic organisms can be found in the   SEQ
CHAPTER \h \r 1 Environmental Fate and Ecological Risk Assessment
(Revised) for Triadimefon, dated January 19, 2006.  

	Fish and Invertebrate Risk

Fish, Aquatic Invertebrates, and Aquatic Plants 

There would be no LOC exceedances for fish, aquatic invertebrates, or
aquatic non-vascular plants for Bayer’s newly proposed turf maximum
application rate of 2 applications of 2.7 lbs. ai/A at 14 day intervals.
 There were no studies available to assess risk to aquatic vascular
plants (See Table 24).

 Table 24.  Aquatic Organism RQ calculations

Crop

App.  rate (# of apps., and interval between apps.)	

Peak EEC

(ppb)	

 Acute Risk Quotients	

 Chronic Risk Quotients

Freshwater Fish

LC50 =4100 ppb	Freshwater Invert.

LC50 = 1600 ppb	Aquatic non-vascular plants 

EC50 = 

17000 ppb	60 Day

EEC	21 Day

EEC	Freshwater 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

	Non-target Aquatic Plants

Risks were below the Agency’s level of concern for non-target aquatic
non-vascular plants. No toxicity data were available to assess risks to
non-target aquatic vascular plants.

Terrestrial Organism Exposure and Risk

	

1)	Bird and Mammal Toxicity

Birds

	Triadimefon is classified as practically non-toxic to birds with acute
oral LD50 values exceeding the highest dose tested (>4000 mg ai/kg bw)
and (>2000 mg ai/kg bw) via an 8-day and 14-day test, respectively. 
With dietary LC50 values between >4640 ppm to >10,000 ppm triadimefon is
classified as practically non-toxic on a subacute dietary basis.  

	Avian single dose oral toxicity studies were also performed on the
major degradate triadimenol.  The acute oral (LD50) toxicity of
triadimenol to bobwhite quail exceeded the highest dose tested (>2000 mg
ai/kg) (MRID 126276).   Additionally, a triadimenol subacute dietary
study was performed with mallard ducks, and no mortality or signs of
toxicity were seen at any doses (LC50 >5000 ppm; MRID 00126277).  The
results of both studies demonstrate that triadimenol is practically
nontoxic to birds on an acute oral and subacute dietary basis.  Table 25
summarizes the data that support the acute and subacute toxicity
endpoints used in assessing the risks to birds for both triadimefon and
its degradate triadimenol. 

Table 25.  Acute Toxicity to Birds

Endpoint	

Chemical	

Environment/Species	

Toxicity Value Used in Risk Assessment	

Reference	Toxicity Classification

Acute Toxicity to Birds	

Triadimefon	

Bobwhite quail	

LD50 = >2000 mg ai/kg bw	

MRID 41895901	Practically non-toxic

	

Triadimenol	

Bobwhite quail	

LD50 = >2000 mg ai/kg bw	

MRID 071469	Practically non-toxic

Subacute Toxicity to Birds	

Triadimefon	

Bobwhite quail	

LC50 = 8392 ppm	

MRID 00050066	Practically non-toxic

	

Triadimenol	

Mallard duck	

LC50 >5000 ppm	

MRID

00126277	Practically non-toxic

  

For chronic toxicity, avian reproduction toxicity tests were performed
using technical triadimefon resulting in a NOAEL of 20 ppm ai (bobwhite
quail).  In addition, avian reproduction toxicity tests were also
performed for the degradate triadimenol with a NOAEL of 100 ppm ai
(mallard duck).  Table 26 summarizes the data for the chronic toxicity
endpoints used in assessing the risks to birds.  

Table 26. Chronic Toxicity to Birds

Species	% a.i.	NOAEL (ppm ai)	LOAEL

 (ppm ai)	LOAEL Endpoints	MRID No. Author/Year

Triadimefon

Northern bobwhite	93	20	100	Eggs cracked, decrease in fertile eggs,
decrease in viable embryos, hatchling, 14-day old survivors	110430
Lamb/1982

Triadimenol

Mallard duck	97	100	500	Eggs laid, decrease in viability, hatchability,
14-day survivors	40283102 Carlisle/1984

 Mammals 

	Triadimefon is classified as slightly toxic to mammals on an acute
basis with LD50 values of 1470 mg/kg (males) and 1090 mg/kg (females). 
Acute toxicity tests showed LD50 values of 689 mg/kg (males) and 752
mg/kg (females) for the degradate triadimenol, classifying it as
slightly toxic to mammals (see Table 27).  

Table 27.  Summary of Acute Toxicity Endpoints for Mammals

Endpoint

	

Chemical	

Species	

Toxicity 

Used in Risk 

Assessment

(Most sensitive Endpoints)	

Reference:	

Classification

Acute Toxicity to Mammals	

Triadimefon	

Rat	

LD50 = 1090 mg/kg (females)	

MRID 00264276	

Acceptable

	

Triadimenol	

Rat	

LD50 = 689 mg/kg

(males)	

MRID 00125411	

Acceptable

Chronic toxicity data for mammals from the 2-generation rat reproduction
study    testing triadimefon indicate decreased pup weights and
viability in the F1 and F2 generations and decreased litter size in the
F2 generation with an offspring NOAEL of 50 ppm ai.  In addition,
chronic toxicity tests for the degradate triadimenol showed decreased
pup weights with a NOAEL of 100 ppm ai and a LOAEL of 500 ppm ai (see
Table 28).

Table 28.  Summary of Chronic Toxicity Endpoints for Mammals

Species	Test Type/

Classification	Toxicity Values Used in Risk Assessment	Affected
Endpoints	MRID No.

Triadimefon

Laboratory Rat

(Rattus norvegicus)	2-generation reproduction	Offspring NOAEL = 50 ppm

Offspring LOAEL = 1800 ppm	Decreased pup weight and viability.	00155075

92188019

92188320

Triadimenol

Laboratory Rat

(Rattus norvegicus)	2-generation reproduction	Parental NOAEL = 100 ppm

Parental LOAEL = 

500 ppm

Offspring NOAEL = 100 ppm

Offspring LOAEL = 500 ppm	Decreased body weights and weight gain

Decreased pup weight

	00151248

				

				2)	Bird and Mammal Exposure

  TC "c.	Terrestrial Organism Exposure" \f C \l "4"  

  SEQ CHAPTER \h \r 1 Pesticide residues on food items are estimated
based on the assumption that terrestrial organisms are exposed to a
single pesticide residue in a given exposure scenario.  Application
methods for liquid triadimefon formulations include ground spray, aerial
spray, and chemigation.  Additionally, granular triadimefon is broadcast
on residential lawns and turf (no soil incorporation).  

The Agency assessed exposure to terrestrial organisms first predicting
the amount of triadimefon residues found on animal food items and then
using information on typical food consumption by various species of
birds and mammals to determine the amount of pesticide consumed. 
Estimated exposure concentrations for terrestrial animals (via spray
applications) were determined by using the standard screening-level
exposure model, TREX (v.1.2) (US EPA, 2005), which calculates pesticide
residues on each type of food item on a daily interval for one year. 
Also, registrant supported golf course use rates and application
intervals were used (2 applications @ 2.7 lbs. ai/A).  

For a single application there is a linear relationship between the
amount of pesticide applied and the amount of pesticide residue present
on a given food item.  These relationships for the various food items
are determined from the Kenaga nomogram, which is a model developed by
Hoerger and Kenaga (1972) and modified by Fletcher (1994). In addition
to incorporating the nomogram relationship, TREX also includes pesticide
degradation in the estimation of EECs.

  SEQ CHAPTER \h \r 1 			3)	Bird and Mammal Risk

Birds

There are acute and chronic LOC exceedances for birds.  The turf maximum
application rate of 2 applications of 2.7 lbs. ai/A at 14 day intervals
results in acute RQ LOC exceedances that are 0.14 for short grass only
and chronic RQ LOC exceedances that range from 4 to 57.  Table 29 shows
the avian acute and chronic risk quotients for turf use of triadimefon. 
An avian acute assessment was not conducted for granular applications
because definitive avian LD50 values were not available for triadimefon
(no mortalities or signs of toxicity were seen in the study at the
highest exposure level). 

Table 29.  Avian Dietary-Based Acute and Chronic RQs for turf uses of
Triadimefon (based on NOAEC of 20 mg/kg diet) based on upper-bound
Kenaga values.

Use

(Application Rate)	Food Items	Upper Bound EEC (mg/kg)	Acute
Dietary-Based RQ (EEC/LC50)	Chronic Dietary-Based RQ (EEC/NOAEC)

Turf  (2.7 lbs. a.i./A, 2 applications, 14 day interval)	Short grass
1139	0.14	57

	Tall grass	522	0.06	26

	Broadleaf plants/small insects	641	0.08	32

	Fruits, pods, seeds, large insects	71	0.01	4

Mammals

For spray application, there are mammalian acute LOC exceedances (LOC >
0.5) for small and medium (15 and 35g) mammals which consume short grass
treated with 2 applications @ 2.7 lbs. ai/A with a 14-day interval.  
Endangered species LOCs are exceeded (LOC> 0.1) for all weight classes
of mammals assessed.  Acute RQs are summarized below in Table 33.

The predicted triadimefon granular EEC values resulting from residential
application at a rate of  2.7 lbs. ai/A (2 applications, 14-day
interval) is 28.12 mg/ft2 (See Table 30).

Table 30.  Mammalian Dose-based Acute RQs for turf uses of Triadimefon
(based on Triadimenol LD50 of 689 mg/kg in rats) based on upper-bound
Kenaga values.

Spray Application

  SEQ CHAPTER \h \r 1 Use	Body Weight (g)	Adjusted LD50	Mammalian
Dose-based Acute Risk Quotients

	Short grass	Tall grass	Broadleaf plants/ small insects	Fruits/pods/
large insects	Seeds

Turf (2.7 lbs. ai/A, 2 applications, 14 day interval)	15	1514	0.72	0.33
0.40	0.04	0.01

	35	1225	0.61	0.28	0.34	0.04	0.01

	1000	530	0.33	0.15	0.18	0.02	0.00

Granular Application

Use	Body Weight (g)	Mg a.i./sq ft	Adjusted LD50	Risk  Quotient

Turf (2.7 lbs. ai/A, 2 applications, 14 day interval)	15	28.12	1514	1.24

	35	28.12	1225	0.66

	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).

  SEQ CHAPTER \h \r 1 Table 31. Mammalian Dietary-based Chronic RQs for
selected uses of non-granular Triadimefon (based on triadimefon rat
NOAEL of 50mg/kg diet) and upper-bound Kenaga values.

Use	Dietary-based Chronic Risk Quotients

	Short Grass	Tall Grass	Broadleaf plants	Fruits/pods/ large
insects/seeds

Turf (2.7 lbs. ai/A, 2 applications, 14 day interval)	22.78	10.44	12.81
1.42

Additional/Potential Dietary Risks to Birds and Mammals

Based on the use of a fugacity-based (equilibrium partitioning)
approach, an estimation of the concentration of triadimefon and its
degradates in earthworms were calculated in order to determine the
possible contribution of earthworm (and other terrestrial invertebrate)
consumption to mammal and avian risk.    SEQ CHAPTER \h \r 1 The
calculated earthworm tissue concentrations of triadimefon/triadimenol
suggest that ingestion of earthworms by birds and mammals based on
dietary dose (triadimefon NOAEC = 20 mg/kg diet and NOAEL = 2.5 mg/kg
bw, respectively) could be another exposure pathway contributing to
chronic risk, although the low earthworm concentrations would
necessitate consumption of a large number of worms. 

			4)	Non-target Terrestrial Plants 

Non-target Terrestrial Plants  

	No guideline studies evaluating the toxicity of triadimefon to
terrestrial plants have been submitted to the Agency.  However, although
several other studies within the Agency’s database were not suitable
for use in determining toxicity endpoints, they can be interpreted
qualitatively to demonstrate potential terrestrial plant risk from
triadimefon.  One such study is summarized below.

	The regrowth of Kentucky bluegrass was inhibited following treatment of
triadimefon.  The same study showed a height decrease in kidney bean
plants.  Although the study did not provide adequate information to
quantitatively calculate RQ values for non-target terrestrial plants,
the results suggest that triadimefon may have negative effects on both
monocot and dicot non-target terrestrial plants.  Please refer to the
environmental fate and effects risk assessment for more detailed
information.

Based on the supported maximum 2 applications for the golf course use
pattern for a maximum single application of 2.7 lbs. a.i./acre, there
would be no LOC exceedances for non-vascular aquatic plants.

	Non-target Insects

  SEQ CHAPTER \h \r 1 EPA currently does not quantify risks to
terrestrial non-target insects; therefore, risk quotients are not
calculated for these organisms.  Based on the acute contact toxicity
study to honeybees, the LD50 for triadimefon is >25 ug ai/bee (MRID
42307804), which classifies it as practically non-toxic to honeybees. 
No data were available for the degradate triadimenol.

	3.	Ecological Incidents

A review of the Ecological Incident Information System (EIIS) was
completed on April 21, 2005.  No incidents involving triadimefon or its
metabolite triadimenol were reported.

		4.	Endangered Species  TC "c.	Endangered Species Concerns" \f C \l "4"
 

The Agency’s screening level ecological risk assessment for endangered
species results in the determination that triadimefon will have no
direct acute effects on threatened and endangered freshwater fish, and
freshwater aquatic invertebrates.  However, the assessment indicates
that triadimefon has the potential for causing risk to endangered birds,
mammals, and non-target plants.  Further, potential indirect effects to
any species dependent upon a species that experiences effect cannot be
precluded from use of triadimefon.  These findings are based solely on
EPA’s screening level assessment and do not constitute “may
effect” findings under the Endangered Species Act.  

IV.	Risk Management, Reregistration, and Tolerance Reassessment Decision

	A.	Determination of Reregistration Eligibility and Tolerance
Reassessment

  SEQ CHAPTER \h \r 1 Section 4(g)(2)(A) of FIFRA calls for the Agency
to determine, after submission of relevant data concerning an active
ingredient, whether or not products containing the active ingredient are
eligible for reregistration.  The Agency has previously identified and
required the submission of the generic (i.e., active
ingredient-specific) data required to support reregistration of products
containing triadimefon as an active ingredient.  The Agency has
completed its review of these generic data, and has determined that the
data are sufficient to support reregistration of all products containing
triadimefon.		

The Agency has completed its assessment of the dietary, occupational,
residential, and ecological risk associated with the use of pesticide
products containing the active ingredient triadimefon.  Based on a
review of these data and on public comments on the Agency’s
assessments for triadimefon, the Agency has sufficient information on
the human health and ecological effects to make decisions as part of the
tolerance reassessment process under FFDCA and reregistration process
under FIFRA, as amended by FQPA.  The Agency has determined that
products containing triadimefon are eligible for reregistration provided
that: (i) required product-specific data are submitted; (ii) risk
mitigation measures outlined in this document are adopted (including
requests for deletion of certain uses); and (iii) label amendments are
made to reflect these measures.  Label changes are described in Section
V.  Appendix A summarizes the uses of triadimefon that are eligible for
reregistration.  Appendix B identifies the generic data requirements
that the Agency reviewed as part of its determination of reregistration
eligibility of triadimefon, and lists the submitted studies that the
Agency found acceptable.  

Based on its evaluation of triadimefon, the Agency has determined that
triadimefon products, unless labeled and used as specified in this
document, would present risks inconsistent with FIFRA.  Accordingly,
should a registrant fail to implement any of the risk mitigation
measures identified in this document, the Agency may take regulatory
action to address the risk concerns from the use of triadimefon.  If all
changes outlined in this document are implemented, then all current
risks for triadimefon will be adequately mitigated for the purposes of
this determination under FIFRA.  Additionally, once an endangered
species assessment is completed, further changes to these registrations
may be necessary, as explained in Section IV..D..4 of this document. 
Once the uses that result in risks of concern are deleted and a
cancellation order is issued, the Agency will take the appropriate
regulatory action under FFDCA to revoke the associated tolerances.

Triadimenol, a metabolite of triadimefon, is also a registered
fungicide. Triadimenol was first registered after 1984 and is not
subject to reregistration under the 1988 amendments to FIFRA. 
Triadimenol is, however, subject to tolerance reassessment under the
FFDCA, as amended by FQPA.  Based on its evaluation of combined
exposures from the uses of triadimefon, triadimenol, and their
metabolites, the Agency has determined that the tolerances for
triadimefon and triadimenol are considered to be reassessed under FFDCA.

	B.	Public Comments and Responses

  SEQ CHAPTER \h \r 1 Through the Agency’s public participation
process, EPA worked extensively with stakeholders and the public to
reach the regulatory decisions for triadimefon.  EPA released its
preliminary risk assessments for triadimefon and triadimenol for public
comment on February 16, 2006, for a 60-day public comment period (Phase
3 of the public participation process).  During the public comment
period on the risk assessments, which closed on April 17, 2006, the
Agency received comments from a public citizen, nursery and forestry
cooperatives, the U.S. Triazole Task Force, and the technical registrant
Bayer CropScience.  These comments in their entirety, responses to the
comments, as well as the preliminary and revised risk assessments, are
available in the public docket for triadimefon (EPA-HQ-OPP-2005-0258)
and for triadimenol (EPA-HQ-OPP-2006-0038) in the EPA’s electronic
docket at   HYPERLINK "http://www.regulations.gov" 
http://www.regulations.gov .

	C.	Regulatory Position under the FFDCA

		1.	Food Quality Protection Act Findings

“Risk Cup” Determination

As part of the FQPA tolerance reassessment process, EPA assessed the
risks associated with this pesticide.  The Agency has determined that,
if the mitigation described in this document is adopted and labels are
amended, human health risks as a result of exposures to triadimefon and
triadimenol are within acceptable levels.  In other words, EPA has
concluded that the tolerances for triadimefon and triadimenol will meet
FQPA safety standards.  In reaching this determination, EPA has
considered the available information on the special sensitivity of
infants and children, as well as exposures to triadimefon and
triadimenol from all possible sources.  Furthermore, if the registrant
does not cancel the uses agreed to or make the mitigation changes
necessary to meet the safety determination, the Agency will take the
appropriate regulatory action.

  SEQ CHAPTER \h \r 1 

			b.	Determination of Safety to U.S. Population

The Agency has determined that the established tolerances for
triadimefon and triadimenol, with amendments and changes as specified in
this document, will meet the safety standards under the FQPA amendments
to section 408(b)(2)(D) of the FFDCA, and that there is a reasonable
certainty no harm will result to the general population or any subgroup
from the use of triadimefon and triadimenol.  In reaching this
conclusion, the Agency has considered all available information on the
toxicity, use practices and exposure scenarios, and the environmental
behavior of triadimefon and triadimenol and their free triazole
degradates.

	As discussed in Section III, the aggregate risks from triadimefon and
triadimenol from food, drinking water, and residential exposure are not
of concern, provided the mitigation measures described in this document
are implemented through amendments to existing registrations. 
Furthermore, aggregate risks from the free triazoles (1,2,4-triazole,
triazole acetic acid, and triazole alanine) are not of concern.  The
aggregate risk assessment for the free triazoles considers all currently
registered uses of all triazole fungicides.

			c.	Determination of Safety to Infants and Children

EPA has determined that the established tolerances for triadimefon and
triadimenol, with amendments and changes as specified in this document,
will meet the safety standards under the FQPA amendments to section
408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no
harm for infants and children.  The safety determination for infants and
children considers factors on the toxicity, use practices and
environmental behavior noted above for the general population, but also
takes into account the possibility of increased dietary exposure due to
the specific consumption patterns of infants and children, as well as
the possibility of increased susceptibility to the toxic effects of
triadimefon and triadimenol residues in this population subgroup.

			d.	Endocrine Disruptor Effects

  SEQ CHAPTER \h \r 1 EPA is required under the FFDCA, as amended by
FQPA, to develop a screening program to determine whether certain
substances (including all pesticide active and other ingredients) “may
have an effect in humans that is similar to an effect produced by a
naturally occurring estrogen, or other endocrine effects as the
Administrator may designate.”  Following recommendations of its
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC),
EPA determined that there was a scientific basis for including, as part
of the program, the androgen and thyroid hormone systems, in addition to
the estrogen hormone system.  EPA also adopted EDSTAC’s recommendation
to include evaluations of potential effects in wildlife.  For
pesticides, EPA will use FIFRA and, to the extent that effects in
wildlife may help determine whether a substance may have an effect in
humans, FFDCA authority to require the wildlife evaluations.  As the
science develops and resources allow, screening of additional hormone
systems may be added to the Endocrine Disruptor Screening Program
(EDSP).

e.	Cumulative Risks

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether
to establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity.”  Other substances are considered to
account for the possibility that low-level exposures to multiple
chemical substances that cause a common effect by a common mechanism
could lead to the same adverse health effect as would a higher level of
exposure to each individual substance.  For the purposes of this
regulatory decision, EPA has concluded that triadimefon and triadimenol
do not share a common mechanism of toxicity with other substances.  The
Agency reached this conclusion after a thorough internal review and
external review of the data supporting a common mechanism of toxicity
for a number of chemical classes.  For information regarding EPA’s
efforts to determine which chemicals have a common mechanism of toxicity
and to evaluate the cumulative effects of such chemicals, see the policy
statements released by EPA’s Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA’s website  
HYPERLINK "http://www.epa.gov/pesicides/cumulative/" 
http://www.epa.gov/pesicides/cumulative/ .

2.	Tolerance Summary for Triadimefon

  SEQ CHAPTER \h \r 1 Tolerances of triadimefon in/on plant and
livestock commodities (40 CFR § 180.410) are presently expressed in
terms of residues of triadimefon and its metabolites containing
chlorophenoxy and triazole moieties (expressed as the parent compound).

			  SEQ CHAPTER \h \r 1 a.	Tolerances Currently Listed Under 40 CFR
§180.410

  SEQ CHAPTER \h \r 1   	Tolerances are established for residues of
triadimefon
[1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)-2-butanone]
and its metabolites containing chlorophenoxy and triazole moieties
(expressed as the parent compound) in/on various plant and animal
commodities [40 CFR §180.410].  The established tolerances for residues
in plant and animal commodities [40 CFR §180.410(a)] range from 0.04
ppm (milk, hog, and poultry commodities) to 145 ppm (grass seed
cleanings).  A tolerance with regional registration is established for
triadimefon and its metabolites in/on raspberries at 2.0 ppm [40 CFR
§180.410(c)].  However, all triadimefon tolerances (except pineapple)
will be proposed for revocation.  

	Residues of triadimenol (and its butanediol metabolite KWG 1342), from
use of triadimenol per se, are regulated separately under 40 CFR
§180.450.  In addition, 40 CFR §180.3(d)(13) specifies that where
tolerances are established for residues of both 1-(4-
chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazole-1-yl)-2-butanone
(triadimefon) and
β-(4-chlorophenoxy)-α-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol
(triadimenol) including its butanediol metabolite,
1-(4-chlorophenoxy)-3,3-dimethyl-3-hydroxymethyl-1-(1H-1,2,4-triazol-1-y
l)-2-butanol (KWG1342), in or on the same raw agricultural commodity and
its products thereof, the total amount of such residues shall not yield
more residue than that permitted by the higher of the two tolerances. 
Currently, triadimefon and triadimenol do not share any uses, so 40 CFR
§180.3(d)(13) should be deleted.  A tolerance summary for triadimefon
is presented in Table 32.

Table 32.  Tolerance Summary for Triadimefon

Commodity	Current Tolerance (ppm)	Reassessed Tolerance (ppm)	Comments 

  SEQ CHAPTER \h \r 1 Tolerances Established Under 40 CFR §180.410(a)

  SEQ CHAPTER \h \r 1 Apple	1	Revoke	  SEQ CHAPTER \h \r 1 Bayer is
voluntarily deleting this use.

  SEQ CHAPTER \h \r 1 Apple, wet pomace and 

Apple, dry pomace	4	Revoke	Bayer is voluntarily deleting this use.  SEQ
CHAPTER \h \r 1 

  SEQ CHAPTER \h \r 1 Barley, milled fractions (except flour)	4	Revoke	 
SEQ CHAPTER \h \r 1 Currently, Bayer does not have any registered uses
of triadimefon on barley.

  SEQ CHAPTER \h \r 1 Beet, sugar	0.5	Revoke	  SEQ CHAPTER \h \r 1
Currently, Bayer does not have any registered uses of triadimefon on
sugar beets.

  SEQ CHAPTER \h \r 1 Beet, sugar, tops	3

  SEQ CHAPTER \h \r 1 Cattle, fat	1	Revoke	  SEQ CHAPTER \h \r 1
Currently, Bayer does not have any registered uses of triadimefon on any
cattle feed items. 

  SEQ CHAPTER \h \r 1 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.

  SEQ CHAPTER \h \r 1 Cattle, meat	1	Revoke

	Cattle, meat byproducts	1	Revoke

	Chickpea, seed	0.1	Revoke	  SEQ CHAPTER \h \r 1 Currently, Bayer does
not have any registered uses of triadimefon on chickpea plants.

  SEQ CHAPTER \h \r 1 Cucurbits	0.3	Revoke	Currently, Bayer does not
have any registered uses of triadimefon on chickpea plants.

  SEQ CHAPTER \h \r 1 Eggs	0.04	Revoke	  SEQ CHAPTER \h \r 1 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.



  SEQ CHAPTER \h \r 1 Goat, fat	1	Revoke	  SEQ CHAPTER \h \r 1
Currently, Bayer does not have any registered uses of triadimefon on any
goat feed items. 

40 CFR §180.6(a)(3) It is not possible to establish with certainty
whether finite residues will be incurred but there is no reasonable
expectation of finite residues.

  SEQ CHAPTER \h \r 1 Goat, meat	1	Revoke

	  SEQ CHAPTER \h \r 1 Goat, meat byproducts	1	Revoke

	  SEQ CHAPTER \h \r 1 Grape	1	Revoke	Bayer is voluntarily deleting this
use.

  SEQ CHAPTER \h \r 1 Grape, wet pomace and Grape, dry pomace	3	

Revoke	  SEQ CHAPTER \h \r 1 No longer considered significant livestock
feed items.

  SEQ CHAPTER \h \r 1 Grape, raisin, waste	7

  SEQ CHAPTER \h \r 1 Grass, forage	0.2	

Revoke

	  SEQ CHAPTER \h \r 1 Currently, Bayer does not have any registered
uses of triadimefon on pasture or rangeland.

  SEQ CHAPTER \h \r 1 Grass, seed screenings	145

  SEQ CHAPTER \h \r 1 Grass, straw, grown for seed	105

  SEQ CHAPTER \h \r 1 Hog, fat	0.04	Revoke	  SEQ CHAPTER \h \r 1
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.

  SEQ CHAPTER \h \r 1 Hog, meat	0.04

Hog, meat byproducts	0.04

Horse, fat	1	

Revoke	  SEQ CHAPTER \h \r 1 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.

Horse, meat	1

Horse, meat byproducts	1

Milk	0.04	Revoke	  SEQ CHAPTER \h \r 1 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	  SEQ CHAPTER \h \r 1 Currently, Bayer does not have
any registered uses of triadimefon on nectarine.

Pear	1	Revoke	Bayer is voluntarily deleting this use.  SEQ CHAPTER \h \r
1 

Pineapple, fresh	3	2	  SEQ CHAPTER \h \r 1 Re-evaluation of data from
field trials shows lower residues are expected. 

[Pineapple]

Poultry, fat	0.04	

Revoke	  SEQ CHAPTER \h \r 1 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.

Poultry, meat	0.04

Poultry, meat byproducts	0.04

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	Revoke	  SEQ CHAPTER \h \r 1 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.

Sheep, meat	1

Sheep, meat byproducts	1

Wheat, forage	15	Revoke	  SEQ CHAPTER \h \r 1 Currently, Bayer does not
have any registered uses of triadimefon on wheat.

Wheat, grain	1

Wheat, milled fractions (except flour)	4

Wheat, straw	5

		

			b.	Codex Harmonization

  SEQ CHAPTER \h \r 1 No Codex maximum residue levels (MRLs) have been
established for triadimefon.

The Codex Alimentarius Commission (Codex) has established several MRLs
for triadimenol in/on various raw agricultural commodities.  The Codex
MRLs are expressed in terms of triadimenol per se.  The MRLs have been
established to accommodate triadimenol residues resulting from the use
of triadimefon and/or triadimenol.  Compatibility cannot be achieved
with the Codex MRLs because these levels are expressed in terms of
triadimenol only; the U.S. tolerances for plant commodities are
expressed in terms of triadimenol, KWG 1342, and KWG 1732 in/on cereal
grains and cotton and triadimenol and KWG 1342 in/on bananas..

			c.	Residue Analytical Methods – Plants/Livestock

  SEQ CHAPTER \h \r 1 The reregistration requirements for residue
analytical methods are fulfilled.  Adequate methods are available for
data collection and for the enforcement of tolerances for residues of
triadimefon  per se in/on plant commodities.  Since there is no
reasonable expectation of residues in poultry, enforcement methods for
the determination of triadimefon residues in livestock commodities are
not needed.  

Plant Commodities.  Two methods of gas chromatography with mass
spectrometry detection (GC/MS) are listed in the Pesticide Analytical
Manual (PAM Vol. II) for enforcement of tolerances in plant and
livestock commodities.  The methods use a single moiety detection in
which residues are converted to p-dichlorophenol, derivatized with
dinitrofluorobenzene, and reported as triadimefon equivalents.  The
GC/MS method is no longer adequate due to the recommended tolerance
expression revisions.  However, a GC method using a nitrogen phosphorus
detector (NPD; Report No. 80488) is available for determination of
residues of triadimefon, triadimenol, KWG 1323, and KWG 1342, and it is
adequate for the enforcement of a pineapple tolerance.  The reported
method limit of quantitation (LOQ) is 0.01 ppm for each analyte.  The
limit of detection (LOD) was not reported.

Livestock Commodities.  The Pesticide Analytical Manual (PAM) Vol. II
lists the two GC/MS methods described above (Methods I and II) for the
determination of triadimefon and its free and conjugated metabolites in
livestock commodities.  Method I (Report No. 69531) is appropriate for
livestock tissues and milk and Method II (Report No. 80265) is
appropriate for livestock tissues and eggs.  The reported LOQ is 0.05
and the LOD is 0.01 ppm for both methods.

Multiresidue Methods.   The 10/99 FDA PESTDATA database (PAM Volume I,
Appendix I) indicates that triadimefon is completely recovered (>80%)
using Multiresidue Methods Section 302 (Luke Method; Protocol D);
recovery of triadimefon is small (<50%) using Multiresidue Methods
Sections 303 (Mills, Onley, and Gaither; Protocol E, nonfatty) and 304
(Mills, fatty food).  Triadimefon metabolites triadimenol and KWG 1323
are completely recovered using Section 302.  Triadimenol, KWG 1323, and
metabolite KWG 1732 are not recovered using Sections 303 and 304.

		3.	Tolerance Summary for Triadimenol

	The current tolerance expression for residues of triadimenol resulting
from direct application to primary crops is adequate.  The Agency has
determined that the tolerance expression for residues in/on cereal
grains (barley, corn, oats, rye, and wheat) and cotton commodities
should include only triadimenol and its metabolites KWG 1342, and KWG
1732.  However, the tolerance expression for residues in/on bananas
should include only triadimenol and its metabolite KWG 1342.  A summary
of triadimenol tolerance reassessments is presented in Table 33.

	

			a.	Tolerances Currently Listed Under 40 CFR §180.450

Tolerances are established for residues of triadimenol and its
butanediol metabolite,
4-(4-chlorophenoxy)-2,2-dimethyl-4-(1H-1,2,4-triazol-1-yl)-1,3-butanedio
l (calculated as triadimenol) in/on various plant commodities.  The
established tolerances in plant commodities range from 0.01 (sorghum
grain and fodder) to 2.5 ppm (green forage of oats, rye, and wheat). 
Tolerances are currently established for residues of triadimenol and its
metabolites containing the chlorophenoxy moiety (calculated as
triadimenol) in livestock commodities at 0.01 ppm (milk and poultry
commodities) and 0.1 ppm (fat, meat, and meat byproducts of cattle,
goats, hogs, horses, and sheep).  

	

Tolerances Needed Under 40 CFR §180.450(a):

Triadimenol is registered for use on barley, corn, cotton, oats, rye,
sorghum, wheat, and bananas as an import tolerance only; however, there
are no existing tolerances associated with barley (hay), oat (hay),
wheat (hay), and cotton (gin byproducts).  Therefore, tolerances will
need to be established for these crops.

Tolerances Under 40 CFR §180.450(b):

The reregistration requirements for data depicting the magnitude of
triadimenol residues of concern in meat, milk, poultry, and eggs have
been fulfilled.  Acceptable ruminant and poultry feeding studies have
been submitted and evaluated.  Triadimenol is not registered for use as
a direct livestock treatment.  The nature of the residue in livestock is
adequately defined for the current uses.  The Agency has concluded that
the supported uses on barley, corn, cotton, oats, rye, and wheat result
in a 40 CFR §180.6(a)(3) situation for ruminant commodities (i.e.,
there is no reasonable expectation of finite residues in ruminant
commodities).  Therefore, additional data on the transfer of residues to
meat, milk, poultry, and eggs are not required and all tolerances for
triadimenol residues in livestock commodities should be revoked pending
results from the requested corn and wheat metabolism studies.  If,
however, foliar uses or registration on additional major livestock feed
items are requested, then triazole and phenyl-labeled livestock
metabolism studies would be required.  Such data may, in turn, trigger
the need for magnitude of the residue (feeding) studies in livestock.

Table 33.  Tolerance Summary for Triadimenol



Commodity	

Current Tolerance (ppm)	

Tolerance Reassessment (ppm)	

Comment/

[Correct Commodity Definition]

Tolerances Established Under 40 CFR §180.450(a)

Banana (Whole)1	0.2	0.2

	Barley, grain	0.05	TBD2

	Barley, straw	0.2	TBD2

	Corn, forage	

0.05	TBD2	[Corn, field, forage]

[Corn, sweet, forage]

Corn, fresh (including sweet), (K+CWHR)	

0.05	TBD2	

[Corn, sweet, K+CWHR]

Corn, grain	0.05	TBD2	[Corn, field, grain]

[Corn, pop, grain]

Corn, stover	0.05	TBD2	[Corn, field, stover]

[Corn, pop, stover]

[Corn, sweet, stover]

Cotton, forage	0.02	Revoke	No longer considered a significant livestock
feed item.

Cotton, undelinted seed	0.02	TBD2

	Oat, grain	0.05	TBD2

	Oat, forage	2.5	TBD2

	Oat, straw	0.2	TBD2

	Rye, forage	2.5	TBD2

	Rye, grain	0.05	TBD2

	Rye, straw	0.1	TBD2

	Sorghum, forage, hay	0.05	Revoke	Use is not being supported.

Sorghum, grain	0.01	Revoke	Use is not being supported.

Sorghum, grain, stover	0.01	Revoke	Use is not being supported.

Wheat, forage	2.5	TBD2

	

Wheat, grain	0.05	TBD2

	

Wheat, straw	0.2	TBD2

	

Tolerances Established Under 40 CFR §180.450(b)

Cattle, fat	0.1	

Revoke	Available data indicate that tolerances for cattle commodities
are not required.

Cattle, meat	0.1

Cattle, meat byproducts	0.1

Egg	0.01	Revoke	Available data indicate that a tolerance for egg is not
required.

Goat, fat	0.1	Revoke	Available data indicate that tolerances for goat
commodities are not required.

Goat, meat	0.1

Goat, meat byproducts	0.1

Hog, fat	0.1	Revoke	Available data indicate that tolerances for hog
commodities are not required.

Hog, meat	0.1

Hog, meat byproducts	0.1

Horse, fat	0.1	Revoke	Available data indicate that tolerances for horse
commodities are not required.

Horse, meat	0.1

Horse, meat byproducts	0.1

Milk	0.01	Revoke	Available data indicate that a tolerance for milk is
not required.

Poultry, fat	0.01	Revoke	Available data indicate that tolerances for
poultry commodities are not required.

Poultry, meat	0.01

Poultry, meat byproducts	0.01

Sheep, fat	0.1	Revoke	Available data indicate that tolerances for sheep
commodities are not required.

Sheep, meat	0.1

Sheep, byproducts	0.1

Tolerances T Be Proposed Under 40 CFR §180.450(a)

Barley, hay	

None established	TBD2	

Cotton, gin byproducts	None established	TBD2

	Oat, hay	None established	TBD2

	Wheat, hay	None established	TBD2

	140 CFR §180.450(a) states that there are no U.S. registrations for
bananas (whole).

2TBD = To be determined.  Additional data are required.  Note that while
additional data are needed, there are no dietary risks associated with
these tolerances and EPA considers them reassessed.

		D.	Regulatory Rationale under FIFRA

  SEQ CHAPTER \h \r 1 The Agency has determined that triadimefon is
eligible for reregistration, in compliance with FIFRA, and the
associated tolerances are considered reassessed, provided that:  1)
required product-specific and generic data are submitted; 2) risk
mitigation measures (including requests to delete certain uses) outlined
in this document are adopted; and 3) label amendments are made to
reflect these measures.  As stated above, the Agency will take steps to
revoke the tolerances associated with the uses that are being deleted.

Risks for currently registered uses of triadimenol are below the
Agency’s level of concern, and no further mitigation is required. The
tolerances for triadimenol are considered reassessed.  Product-specific
and generic data are required to be submitted, as specified in section
V.

The following is a summary of the rationale for managing risks
associated with the use of triadimefon.  Where labeling revisions are
required, specific language is set forth in the summary tables of
Chapter V of this document.

		 1.	Human Health Risk Management

Dietary (Food and Water) Risk Mitigation

	Bayer, the sole technical registrant, has agreed to voluntarily delete
all triadimefon food uses, except for pre-plant and post-harvest use on
pineapples. Food uses to be deleted include apples, pears, grapes, and
raspberries (in both commercial and residential settings). In order to
reduce potential drinking water exposure to triadimefon, use on turf
will be restricted to golf courses and sod farms, only, with a maximum
single application rate of 2.7 lbs ai/A, and a maximum yearly rate of
5.4 lbs ai/A.  With the above use deletions and restrictions, aggregate
(food and water) risks are below the Agency’s level of concern.

			b.	Residential Risk Mitigation

	The following residential uses will remain as labeled use sites for
triadimefon:

Outdoor ornamental flowers, shrubs, and trees;

Greenhouse ornamental flowers, shrubs, and trees.

Bayer, the sole technical registrant, has agreed to request voluntary
deletions of the residential turf use to address post-application and
aggregate risks to toddlers. In addition, a 17-day post-application,
pre-harvest interval is required for sod farm turf, to address potential
risks to toddlers exposed to sod farm turf transplanted to a residential
setting.

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

Package all wettable powder products in water-soluble bags;

Prohibit application with hose-end sprayers in residential greenhouses;

Reduce the application rate for all outdoor ornamental applications to a
maximum of 0.0025 lbs ai/gallon (for certain use sites, rates will
remain lower than this maximum).

Currently, the number of applications that can be made to golf course
turf is not specified on product labels.  Golf course use will be
restricted to a maximum single application rate of 2.7 lbs ai/A, and a
maximum yearly rate of 5.4 lbs ai/A.  Although aggregate risks to
golfers (youths and adults) do not currently exceed the Agency’s level
of concern, this mitigation measure will further reduce exposure to
golfers.

Occupational Risk Mitigation

The following commercial and agricultural uses will remain as labeled
use sites for triadimefon:

Golf course turf

Sod farm turf

Outdoor ornamental flowers, shrubs, and trees

Greenhouse ornamental flowers, shrubs, and trees

Roses

Azaleas, for control of pine-twisting rust only

Pines, including Christmas trees

Pine seedlings

Pine seed (in-nursery and commercial)

Pineapples (pre-plant and post-harvest dip)

Bayer, the sole registrant has requested that use on apples, pears,
grapes, raspberries, and all turf other than golf course and sod farm
turf be voluntarily deleted, reducing handler exposure.  For golf
courses and sod farms, a maximum single application rate of 2.7 lbs
ai/A, and a maximum yearly rate of 5.4 lbs ai/A are required, further
reducing handler exposure.  Golf course applications will be restricted
to turf less than 2.5 inches in height, which will limit application to
golf course roughs.

In order to address risks to occupational handlers mixing, loading, and
applying triadimefon, the mitigation listed below is required:

(1) Require all wettable powder products to be packaged in water-soluble
bags (an engineering control).

(2) Require closed cockpits for aerial applications.

(3) Require chemical-resistant gloves for occupational handlers
performing the following activities:

Mixing and loading all formulations (liquids, wettable powders, dry
flowables)

Loading granulars;

Making applications with handheld equipment;

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

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

Applying a ready-to-use briquette to pine seedlings.

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

Dipping pineapples (pre-plant, and post-harvest);

Dipping pine seed (for on-nursery applications).

With the above engineering controls and personal protective equipment,
risks to residential handlers are below the Agency’s level of concern.

d.	Aggregate Risk Mitigation for Triazole Metabolites

	Acute, short- and intermediate-term, and chronic aggregate risks for
degradates 1,2,4-triazole, triazole alanine, and triazole acetic acid
are below the Agency’s level of concern.  The Agency considered the
contribution of acute and chronic dietary risks from food and drinking
water as well as residential handler and post-application exposures in
the aggregate risk assessment for the free triazoles.  Therefore, no
further mitigation is necessary at this time.

			

   SEQ CHAPTER \h \r 1 2.	Environmental Risk Mitigation

A number of the mitigation measures described above will reduce exposure
and risks to mammals and birds.  These include:

Deleting all outdoor food uses of triadimefon (pears, apples, grapes,
and raspberries);

Limiting turf application rates to a maximum single application rate of
2.7 lbs ai/A, and a maximum yearly rate of 5.4 lbs ai/A (reduced from no
limit on the number of applications);

Prohibiting use on residential turf (only application to golf course and
sod farm turf will continue);

Limiting golf course applications to turf that is less than 2.5 inches
in height (this will reduce application to golf course roughs, which are
usually 3 or more inches in height).

 3.	Other Labeling

  SEQ CHAPTER \h \r 1 In order to be eligible for reregistration,
various use and safety information will be required in the labeling of
all end-use products containing triadimefon.  For the specific labeling
statements and a list of outstanding data, refer to Section V of this
RED document.

 4.	Endangered Species Program

The Agency’s screening level ecological risk assessment for endangered
species results in the determination that triadimefon will have no
direct acute effects on threatened and endangered freshwater fish, and
freshwater aquatic invertebrates.  However, the assessment indicates
that triadimefon has the potential for causing acute risk to endangered
birds, mammals, and non-vascular aquatic plants.  Chronic RQs for
endangered mammals exceed the level of concern at all application rates
modeled.  Chronic RQs for endangered birds also exceed the level of
concern.  No data are available to assess the risks to estuarine/marine
invertebrates, estuarine/marine fish, vascular aquatic plants, and
terrestrial plants.  Therefore, risks cannot be precluded on these
species at this time.

Further, potential indirect effects to any species dependent upon a
species that experiences effect cannot be precluded from use of
triadimefon.  These findings are based solely on EPA’s screening level
assessment and do not constitute “may effect” findings under the
Endangered Species Act.  

  SEQ CHAPTER \h \r 1 The Agency has developed the Endangered Species
Protection Program to identify pesticides whose use may cause adverse
impacts on endangered and threatened species, and to implement
mitigation measures that address these impacts.  The Endangered Species
Act requires federal agencies to ensure that their actions are not
likely to jeopardize listed species or adversely modify designated
critical habitat.  To analyze the potential of registered pesticide uses
that may affect any particular species, EPA uses basic toxicity and
exposure data developed for the REDs and considers ecological
parameters, pesticide use information, geographic relationship between
specific pesticide uses and species locations, and biological
requirements and behavioral aspects of the particular species.  This
analysis will consider the risk mitigation measures that are being
implemented as a result of this regulatory decision. 

	Following this future species-specific analysis, a determination that
there is a likelihood of potential impact to a listed species or its
critical habitat may result in: limitations on the use of triadimefon;
other measures to mitigate any potential impact; or consultations with
the Fish and Wildlife Service or the National Marine Fisheries Service
as necessary.  If the Agency determines that use of triadimefon “may
affect” listed species or their designated critical habitat, EPA will
employ the provisions in the Services regulations (50 CFR Part 402). 
Until that species-specific analysis is completed, the risk mitigation
measures being implemented through this RED will reduce the likelihood
that endangered and threatened species may be exposed to triadimefon at
levels of concern.  EPA is not requiring specific triadimefon label
language at the present time relative to threatened and endangered
species.  If, in the future, specific measures are necessary for the
protection of listed species, the Agency will implement them through the
Endangered Species Protection Program.

V.	What Registrants Need to Do

The use of currently registered products containing triadimefon in
accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment provided that the risk
mitigation measures and label changes (including use deletions) outlined
in this document are implemented.  Therefore, all remaining uses of
these products are eligible for reregistration.  These products will be
reregistered once the required confirmatory generic data, product
specific data, CSFs, and revised labeling are received and accepted by
EPA.  Products that contain other ingredients in addition to triadimefon
will be reregistered when all of their other active ingredients are also
reregistered.

A.	  SEQ CHAPTER \h \r 1 For triadimefon technical grade active
ingredient products, the registrant needs to submit the following items:

  SEQ CHAPTER \h \r 1 Within 90 days from receipt of the generic data
call in (DCI):

	1.	Completed response forms to the generic DCI (i.e., DCI response form
and requirements status and registrant’s response form); and 

	2.	Any time extension and/or waiver requests with a full written
justification.

Within the time limit specified in the generic DCI:

	1.	Citations of any existing generic data that address data
requirements or submit new generic data responding to the DCI.  

Please contact John W. Pates, Jr. at (703) 308-8195 with questions
regarding generic reregistration.

By U.S. Mail:					By express or courier service:

Document Processing Desk (DCI/SRRD)	Document Processing Desk (DCI/SRRD)	

John W. Pates, Jr.				John W. Pates, Jr.

U.S. EPA (7508P)				Office of Pesticide Programs (7504P)

1200 Pennsylvania Ave., NW			  SEQ CHAPTER \h \r 1 Room S-4900

  SEQ CHAPTER \h \r 1 Washington, DC 20460			One Potomac Yard

  SEQ CHAPTER \h \r 1 					Arlington, VA 22202

  SEQ CHAPTER \h \r 1 For end-use products containing the active
ingredient triadimefon, the registrant needs to submit the following
items for each product:

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

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

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

	Within eight months from the receipt of the PDCI:

	(1)	two copies of the confidential statement of formula (EPA Form
8570-4); 

	

a completed original application for reregistration (EPA Form 8570-1). 
Indicate on the form that it is an “application for reregistration”;

five copies of the draft label, incorporating all label amendments
outlined in Table 33 of this document;

a completed form certifying compliance with data compensation
requirements (EPA Form 8570-34);

if applicable, a completed form certifying compliance with cost share
offer requirements (EPA Form 8570-32); and

the product-specific data responding to the PDCI.

Please contact Veronica Dutch at (703) 308-8047 with questions regarding
product reregistration and/or the PDCI.  All materials submitted in
response to the PDCI should be addressed:

By US mail:					By express or courier service only:

Document Processing Desk (PDCI/PRB)	Document Processing Desk (PDCI/PRB)

Veronica Dutch				Veronica Dutch

US EPA (7508P)				Office of Pesticide Programs (7504P)

1200 Pennsylvania Ave., NW			Room S-4900

Washington, DC 20460			One Potomac Yard

					Arlington, VA 22202

A.	Manufacturing Use Products

1.	Generic Data Requirements for Triadimefon

  SEQ CHAPTER \h \r 1 The generic data base supporting the
reregistration of triadimefon for the above eligible uses has been
reviewed and determined to be substantially complete.  However, the
following data requirements are necessary to confirm the reregistration
eligibility decision documented in this RED:

Human Health Effects

Guideline Study Name	New OPPTS Guideline No.	Old Guideline No.

Developmental Neurotoxicity Study (DNT)	870.6300	83-6

Ecological Effects

Guideline Study Name	New OPPTS Guideline No.	Old Guideline No.

Estuarine/Marine Mollusk EC50	850.1025	72-3 B

Estuarine/Marine Shrimp EC50	850.1035	72-3 C

Estuarine/Marine Fish LC50	850.1075	72-3 A

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

  SEQ CHAPTER \h \r 1 To ensure compliance with FIFRA, manufacturing-use
product (MUP) labeling should be revised to comply with all current EPA
regulations, PR Notices, and applicable policies.  The MUP labeling
should bear the labeling contained in the labeling table, which will be
issued separately.

		B.	End-Use Products

			1.	Additional Product-Specific Data Requirements

  SEQ CHAPTER \h \r 1 Section 4(g)(2)(B) of FIFRA calls for the Agency
to obtain any needed product-specific data regarding the pesticide after
a determination of eligibility has been made.  The Registrant must
review previous data submissions to ensure that they meet current EPA
acceptance criteria and if not, commit to conduct new studies.  If a
registrant believes that previously submitted data meet current testing
standards, then the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form
provided for each product.

A product-specific data call-in, outlining specific data requirements,
accompanies this RED.

			2.	Labeling for End-Use Products

  SEQ CHAPTER \h \r 1 Labeling changes are necessary to implement
measures outlined in Section IV above.  Specific language to incorporate
these changes is specified in Table 34.

	C.	Data Requirements for Triadimenol

There are data that must be submitted to support the continuing
registration of triadimenol.  These data are not expected to change the
regulatory conclusions for triadimenol described in this document.  A
generic DCI will be issued and will require development and submission
of these listed data in order to confirm the conclusions outlined in
this document.  

Product Chemistry

Guideline Study Name	New OPPTS Guideline No.	Old Guideline No.

Stability	830.6313	63-13

pH ( H20 solutions)	830.7000	63-12

Ultraviolet/visible Absorption	830.7050	None

Partition Coefficient (N-octanol/water)	830.7550

830.7560  

OR

830.7570	

63-11

Water Solubility	830.7840

OR

830.7860	

63-8

Residue Chemistry

Separate metabolism studies with triazole-14C and phenyl-14C labeled
triadimenol applied as a seed treatment to wheat and corn must be
conducted to confirm residues of concern.

Storage stability data for triadimenol, KWG 1342, and KWG 1732 in/on
field corn, sweet corn, cotton, and wheat processed commodities are
required pending the results from the requested metabolism studies. 
Storage stability data for KWG 1732 in/ on wheat forage, hay, and straw
are required pending the results from the requested metabolism studies.

Crop field trial data depicting residues of triadimenol, KWG 1342, and
KWG 1732 in/on field corn (forage, grain, stover), sweet corn (forage,
kernel plus cob with husks removed, grain, and stover), cotton
(undelinted seed and gin byproducts), and wheat (forage, grain, hay, and
straw) grown from seed treated at the maximum rate are required pending
the results from the requested metabolism studies.

A wheat processing study conducted with triadimenol applied to wheat as
a seed treatment should be submitted once the requested corn or wheat
metabolism studies have been submitted and reviewed.

Limited field rotational crop studies for triadimenol must be submitted
pending the results from the requested metabolism studies. 

D.	Labeling Changes Summary Table

For triadimefon to be eligible for reregistration, all triadimefon
labels must be amended to incorporate the risk mitigation measures
outlined in Section IV.  Table 34 describes how language on the labels
should be amended. 

Table 34.  Labeling Changes Summary Table							

Summary of Labeling Changes for Triadimefon

Description	

Amended Labeling Language	

Placement on Label

Manufacturing Use Products

One of these statements may be added to a label to allow reformulation
of the product for a specific use or all additional uses supported by a
formulator or user group	

Only for formulation into a fungicide for the following use(s): golf
course turfgrass, sodfarm turfgrass, outdoor- and greenhouse-grown
ornamentals (trees, shrubs, flowering plants, including roses), azaleas
(for control of pine-twisting rust only), pine trees (including
Christmas trees), pine seedlings, pine 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 or commercial settings on apples,
grapes, pears, raspberries, azaleas (except to control pine-twisting
rust only), or turfgrass (except for turfgrass on golf courses or
sodfarms).”

“This product can not be formulated into liquid concentrate end-use
products with directions for use on azaleas, pine seedlings, pine seeds,
or pineapple.”

“This product can not be formulated into dry flowable end-use products
with directions for use on pine trees, pine seedlings, or pineapple.”

“This product can be formulated into granular end-use products with
directions for use only on golf course turfgrass or sodfarm
turfgrass.”	

Directions for Use

	

“This product may be used to formulate products for specific use(s)
not listed on the MP label if the formulator, user group, or grower has
complied with U.S. EPA submission requirements regarding support of such
use(s).”	

Directions for Use

Environmental Hazards	 

“Do not discharge effluent containing this product into lakes,
streams, ponds, estuaries, oceans, or other waters unless in accordance
with the requirements of a National Pollutant Discharge Elimination
System (NPDES) permit and the permitting authority has been notified in
writing prior to discharge.  Do not discharge effluent containing this
product to sewer systems without previously notifying the local sewage
treatment plant authority.  For guidance, contact your State Water Board
or Regional Office of the EPA.”	

Precautionary Statements immediately following the User Safety
Recommendations



End Use Products Intended for Occupational Use (WPS and NonWPS) 

PPE Requirements Established by the RED1 for liquid concentrate end-use
products 	

“Personal Protective Equipment (PPE)”

“Some materials that are chemical-resistant to this product are
(registrant inserts correct chemical-resistant material).  If you want
more options, follow the instructions for category [registrant inserts
A,B,C,D,E,F,G,or H] (on an EPA chemical-resistance category selection
chart.”

“Mixers, loaders, applicators, flaggers, and other handlers must wear:

> Long sleeved shirt and long pants,

> Shoes plus socks, and

>Chemical resistant gloves, such as (registrant insert correct
chemical-resistant materials) when mixing/loading or when applying using
handheld equipment or handheld nozzles.”

 

“See engineering controls for additional requirements.”	

Immediately following/below 

Precautionary Statements:  Hazards to Humans and Domestic Animals 

PPE Requirements Established by the RED1 for dry flowable end-use
products 

Note:  if the end-use product does not have directions for use as a seed
treatment, then the phrase “or when handling treated seed (including
spreading, drying, raking, bagging, and sewing seed bags)” may be
dropped.	

“Personal Protective Equipment (PPE)”

“Some materials that are chemical-resistant to this product are
(registrant inserts correct chemical-resistant material).  If you want
more options, follow the instructions for category [registrant inserts
A,B,C,D,E,F,G,or H] (on an EPA chemical-resistance category selection
chart.”

“Mixers, loaders, applicators, flaggers, and other handlers must wear:

> Long sleeved shirt and long pants,

> Shoes plus socks, and

>Chemical resistant gloves, such as (registrant insert correct
chemical-resistant materials) when mixing/loading, when applying using
handheld equipment or handheld nozzles, or when handling treated seed
(including spreading, drying, raking, bagging, and sewing seed bags).”

 

“See engineering controls for additional requirements.”	

Immediately following/below 

Precautionary Statements:  Hazards to Humans and Domestic Animals 

PPE  Requirements Established by the RED1 for wettable powder end-use
products 

 Note: all wettable powder products must be in water soluble packets to
be eligible for reregistration. 

Note:  if the end-use product does not have directions for use as a seed
treatment, then the phrase “or when handling treated seed (including
spreading, drying, raking, bagging, and sewing seed bags)” may be
dropped.

Note:  if the end-use product does not have directions for use as a dip
treatment, then the phrases “participating in  dip applications” may
be dropped.	

“Personal Protective Equipment (PPE)”

“Some materials that are chemical-resistant to this product are
(registrant inserts correct chemical-resistant material).  If you want
more options, follow the instructions for category [registrant inserts
A,B,C,D,E,F,G,or H] (on an EPA chemical-resistance category selection
chart.”

“Mixers, loaders, applicators, flaggers, and other handlers must wear:

> Long sleeved shirt and long pants,

> Shoes plus socks,

> Chemical resistant gloves, such as (registrant insert correct
chemical-resistant materials) when mixing/loading, when using handheld
equipment or handheld nozzles, when participating in dip applications,
or when handling treated seed (including spreading, drying, raking,
bagging, and sewing seed bags), and

> Chemical-resistant apron, when mixing/loading, when participating in
dip applications, or cleaning spills or equipment.”

“See engineering controls for additional requirements.”	

Immediately following/below 

Precautionary Statements:  Hazards to Humans and Domestic Animals 

PPE Requirements Established by the RED1 for granular products	

“Personal Protective Equipment (PPE)”

“Some materials that are chemical-resistant to this product are
(registrant inserts correct chemical-resistant material).  If you want
more options, follow the instructions for category [registrant inserts
A,B,C,D,E,F,G,or H] (on an EPA chemical-resistance category selection
chart.”

“Loaders, applicators, flaggers, and other handlers must wear:

> Long-sleeved shirt and long pants, 

> Shoes plus socks, and

> Chemical resistant gloves, such as (registrant insert correct
chemical-resistant materials) when loading.”

“See engineering controls for additional requirements.”	

Immediately following/below 

Precautionary Statements:  Hazards to Humans and Domestic Animals 

PPE Requirements Established by the RED1 for ready-to-use briquette
products	

“Personal Protective Equipment (PPE)”

“Some materials that are chemical-resistant to this product are
(registrant inserts correct chemical-resistant material).  If you want
more options, follow the instructions for category [registrant inserts
A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection
chart.”

“Applicators and other handlers must wear:

> Long-sleeved shirt and long pants, 

> Shoes plus socks, and

> Chemical resistant gloves, such as (registrant insert correct
chemical-resistant materials). “	

Immediately following/below 

Precautionary Statements:  Hazards to Humans and Domestic Animals 

PPE Requirements Established by the RED1 for tree-injection products

Note:  if the tree-injection product is ready-to-use, the words
“mixers, loaders” may be dropped	

“Personal Protective Equipment (PPE)”

“Some materials that are chemical-resistant to this product are
(registrant inserts correct chemical-resistant material).  If you want
more options, follow the instructions for category [registrant inserts
A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection
chart.”

“Mixers, loaders, applicators and other handlers must wear:

> Long-sleeved shirt and long pants, 

> Shoes plus socks, and

> Chemical resistant gloves, such as (registrant insert correct
chemical-resistant materials).”	

Immediately following/below 

Precautionary Statements:  Hazards to Humans and Domestic Animals 

User Safety Requirements 	

“Follow manufacturer's instructions for cleaning/maintaining PPE.  If
no such instructions for washables exist, use detergent and hot water. 
Keep and wash PPE separately from other laundry.”

“Discard clothing and other absorbent materials that have been
drenched or heavily contaminated with this product’s concentrate.  Do
not reuse them.”	

Precautionary Statements:  Hazards to Humans and Domestic Animals
immediately following the PPE requirements

Engineering Controls for liquid, dry flowable , or granular formulations
that contain directions for use for sodfarm turfgrass 

	

“Engineering Controls”

“Pilots must use an enclosed cockpit in a manner that is consistent
with the WPS for Agricultural Pesticides [40 CFR170.240(d)(6)]. Pilots
must wear the PPE required on this labeling for applicators.”	

Precautionary Statements:  Hazards to Humans and Domestic Animals  
(Immediately following PPE and User Safety Requirements.) 

Engineering Controls for wettable powders packaged in water-soluble
packets.  All wettable powders must be in water soluble packets to be
eligible for reregistration.	

“Engineering Controls”

“Water soluble packets when used correctly qualify as a closed
mixing/loading system under the Worker Protection Standard for
Agricultural Pesticides [40 CFR 170.240(d)(4).  Mixers and loaders using
water soluble packets must:

-wear the personal protective equipment required on this labeling for
mixers and loaders, and

-be provided, have immediately available, and wear in an emergency, such
as a broken package, spill, or equipment breakdown:

>chemical resistant footwear and 

>a NIOSH-approved respirator equipped with:

-- a dust/mist filter with MSHA/NIOSH approval number prefix TC-21C or

-- any N, R, P, or HE filter.”

“Pilots must use an enclosed cockpit in a manner that is consistent
with the WPS for Agricultural Pesticides [40 CFR170.240(d)(6)].  Pilots
must wear the PPE required on this labeling for applicators.”	

Precautionary Statements:  Hazards to Humans and Domestic Animals  
(Immediately following PPE and User Safety Requirements.) 

User Safety Recommendations	

“User Safety Recommendations”

“Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet.”

“Users should remove clothing/PPE immediately if pesticide gets
inside.  Then wash thoroughly and put on clean clothing.”

“Users should remove PPE immediately after handling this product. 
Wash the outside of gloves before removing.  As soon as possible, wash
thoroughly and change into clean clothing.”

	

Precautionary Statements under:  Hazards to Humans and Domestic Animals
immediately following Engineering Controls

(Must be placed in a box.)

Environmental Hazards	

“ ENVIRONMENTAL HAZARDS” 

“Do not apply directly to water, or to areas where surface water is
present or to intertidal areas below the mean water mark.  Do not
contaminate water when disposing of equipment washwater or rinsate.”

“Do not apply when weather conditions favor drift from treated areas. 
Drift and runoff from treated areas may be hazardous to organisms in
neighboring areas.”

“This product may contaminate water through runoff. This product has a
high potential for runoff for several months or more after application.
Poorly draining soils and soils with shallow water tables are more prone
to produce runoff that contains this product.”

“This chemical has properties and characteristics associated with
chemicals detected in ground water. The use of this chemical in areas
where soils are permeable, particularly where the water table is
shallow, may result in ground water contamination.”	

Environmental Hazards

Restricted-Entry Interval (for labels with WPS uses)

Note: the prohibition for sodfarms may be dropped if the end-use product
does not contain directions for use on sodfarms	

“Do not enter or allow worker entry into treated areas during the
restricted entry interval (REI) of 12 hours.”

“Harvesting or transplanting turfgrass grown on sodfarms is prohibited
for 17 days following application.”	

Directions for Use, Agricultural Use Requirements Box

Early Reentry Personal Protective Equipment established by the RED (for
labels with WPS uses)	

“PPE required for early entry to treated areas that is permitted under
the Worker Protection Standard and that involves contact with anything
that has been treated, such as plants, soil, or water, is:

> coveralls,

> shoes plus socks, and

> chemical-resistant gloves made of any waterproof material.”	Place in
the Directions for Use In Agricultural Use Requirements box, immediately
following the REI

Entry Restriction for NonWPS uses	

Entry Restriction for non-WPS uses applied as a spray (does not include
tree-injection uses):

“Do not enter or allow others to enter until sprays have dried.”

Entry Restriction for non-WPS uses applied dry (does not include
ready-to-use briquette uses):

“Do not enter or allow others to enter until dusts have settled.”

Entry Restriction for non-WPS uses applied as a granular and when
watering-in is required:

“Do not enter or allow others to enter the treated area (except those
involved in watering-in) until watering-in is complete and the surface
is dry.” 	

If no WPS uses on the label, place the statements in the Directions for
Use Under General Precautions and Restrictions.

If WPS uses are also on the labeling, place these statements in a
NonAgricultural Use Requirements box as specified in PR Notice 93-7 and
93-11.

General Application Restrictions (for labels with WPS uses)	

“Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may
be in the area during application.”	

Place in the Directions for Use directly above the Agricultural Use Box.

Other Application Restrictions (Risk Mitigation)	

All Products/Formulations Containing Triadimefon

Delete all directions for use for the following use-patterns:

> apples

> grapes

> pears

> raspberries

> residential or commercial turfgrass (except for turfgrass on golf
courses or sodfarms).

Include the following statement: “Application to trees that bear fruit
or nuts is prohibited.  Applications are permitted on nonbearing fruit
or nut trees only.”	

Directions for Use

Spray Drift	

“Spray drift requirements”

(1)   SEQ CHAPTER \h \r 1 For groundbloom and aerial applications, use
only medium or coarser spray nozzles according to ASABE (S572)
definition for standard nozzles. Aerial applicators must consider flight
speed and nozzle orientation in determining droplet size. 

(2)   SEQ CHAPTER \h \r 1 Make aerial or ground applications when the
wind velocity is 3 to 10 mph. Do not apply when the wind speed is
greater than 10 mph. For all non-aerial applications, wind speed must be
measured adjacent to the application site on the upwind side,
immediately prior to application.

(4)   SEQ CHAPTER \h \r 1 Do not make aerial or ground applications into
temperature inversions.

(5)   SEQ CHAPTER \h \r 1 For groundboom applications, apply with nozzle
height no more than 4 feet above the ground or crop canopy.

(6) For airblast applications, turn off outward pointing nozzles at row
ends and when spraying the outer two rows. To minimize spray loss over
the top in tree applications, spray must be directed into the canopy.

(7) For aerial applications, do not release spray at a height greater
than 10 feet above the ground or plant canopy.

(8) For aerial applications, the outermost nozzles must not exceed 60%
of the wingspan or 80% of the rotor blade diameter.

(9)   SEQ CHAPTER \h \r 1 When aerial applications are made with a
cross-wind, the swath will be displaced downwind.  The applicator must
compensate for this displacement at the downwind edge of the application
area by adjusting the path of the aircraft upwind.”

	

Application Restrictions for Turfgrass Uses 

(Note: The maximum allowable application rate per application or per
year must be listed as pounds or gallons of formulated product per acre,
not solely as pounds active ingredient per acre.)	

“Use on turfgrass is limited to sodfarm turf and golf course turf
only.  Use on turfgrass is prohibited on all other residential and
commercial sites.”

Maximum application rate is 2.7 lb ai/A

Maximum annual application rate is 5.4 lb ai/A

Minimum retreatment interval is 14 days.

“Aerial application and chemigation to turf are permitted on sodfarm
turfgrass only.”

“Application to golf courses, including tees, greens, fairways, and
roughs, is permitted only if the turfgrass is 2.5 inches or less in
height.”

“Harvesting or transplanting turfgrass grown on sodfarms is prohibited
for 17 days following application.”

	

Directions for Use associated with turfgrass use directions

Application Restrictions for Azaleas	

“Use on azaleas is limited to applications to control pine-twisting
rust disease.” 	

Directions for Use associated with azalea use directions

Application Restrictions for Ornamentals and Pine Trees, including
Christmas trees	

“Chemigation is permitted for use on ornamentals and pine trees,
including Christmas trees.”

	

Application Restrictions for Ornamentals at Residential Sites

Note: The maximum allowable application rate must be listed as pounds or
gallons of formulated product per acre, not solely as pounds active
ingredient per gallon.)	

“The maximum application rate for ornamentals (including azaleas) at
residential sites is 0.0025 lb ai/gal.”	

Directions for Use associated with ornamental use directions

End Use Products Intended Primarily for Use by Homeowners

Environmental Hazards	

“ ENVIRONMENTAL HAZARDS” 

“Do not apply directly to water. Do not contaminate water when
disposing of equipment washwaters or rinsate.”

“Do not apply when weather conditions favor drift from treated areas. 
Drift and runoff from treated areas may be hazardous to organisms in
neighboring areas.”

“This product may contaminate water through runoff. This product has a
high potential for runoff for several months or more after application.
Poorly draining soils and soils with shallow water tables are more prone
to produce runoff that contains this product.”

“This chemical has properties and characteristics associated with
chemicals detected in ground water. The use of this chemical in areas
where soils are permeable, particularly where the water table is
shallow, may result in ground water contamination.”	

Precautionary Statements

Application Restrictions	

All products:

“Do not apply this product in a way that will contact any person or
pet, either directly or through drift.  Keep people and pets out of the
area during application.”

	

Directions for Use under General Precautions and Restrictions

Statements must be in the color red and in all caps.

Entry Restrictions	

Products Applied as a Liquid (except tree-injection uses):

“Do not allow people or pets to enter the treated area until sprays
have dried.”	

Directions for Use under General Precautions and Restrictions

Directions for Use	

“Do not apply this product to lawns or other turfgrass.”	

Directions for Use section

Directions for Use on Ornamentals

Note: The maximum allowable application rate must be listed as pounds or
gallons of formulated product per acre, not solely as pounds active
ingredient per gallon.)	

“Applications with hose-end sprayers are permitted only for outdoor
use on ornamentals.  Use of hose-end sprayer equipment in residential
greenhouses is prohibited.”

“The maximum application rate for ornamentals is 0.0025 lb ai/gal.”

	

Directions for Use section associated with the directions for ornamental
uses

Other Application Restrictions (Risk Mitigation)	

All Products/Formulations Containing Triadimefon

Delete all directions for use for the following use-patterns:

> apples

> grapes

> pears

> raspberries

> residential or commercial turfgrass

Include the following statement: “Application to trees that bear fruit
or nuts is prohibited.  Applications are permitted on nonbearing fruit
or nut trees only.”	

Directions for Use

1 PPE that is established on the basis of Acute Toxicity of the end-use
product must be compared to the active ingredient PPE in this document. 
The more protective PPE must be placed in the product labeling.  For
guidance on which PPE is considered more protective, see PR Notice 93-7.

2 The registrant must drop the N type filter from the respirator
statement if the pesticide product contains or is used with oil.

Instructions in the Labeling section appearing in quotations represent
the exact language that should appear on the label.

Instructions in the Labeling section not in quotes represents actions
that the registrant should take to amend their labels or product
registrations.



VI. AppendicesAppendix A:  Use Patterns Subject to Reregistration for
Triadimefon

Site

Application Type

Application Timing

Application Equipment

	Formulation	

Max. Single Application Rate

(ai)	Max. # Apps.	Minimum Retreatment Interval (Days)	Use Limitations

(Food Uses)

Pineapples (post-harvest or  pre-plant crowns)

Pre-plant and Post-harvest dip, spray

	WP	0.0028 lbs ai/gallon	1	Not Required; since only one application. 

(NR)	All wettable powder products must be packaged in water soluble
bags.

(Non-food Uses)

Azaleas (for control of pine twisting rust, only

Chemigation, groundboom, low-pressure handwand, high pressure handwand

	WP

DF	0.005 lbs ai/gallon	8	14	All wettable powder products must be
packaged in water soluble bags.

Christmas trees

Aerial, flagging, airblast

	WP	0.25 lbs ai/A	8	14	A closed cockpit is required for aerial
applications (all formulations).

All wettable powder products must be packaged in water soluble bags.

Golf Course Turf

Groundboom, LCO handgun, low-pressure handwand, and handgun sprayer

Flagging, tractor-drawn spreader

	LC

WP

DF

G	2.7 lbs ai/A	2

(at max. single app. rate)	14	Use is restricted to golf course and sod
farm turf, only.

A maximum annual application rate of 5.4 lbs ai/A is allowed.

Applications are restricted to turf less than 2.5 inches in height. 
This applies to the entire golf course, including tees, greens,
fairways, and roughs.

All wettable powder products must be packaged in water soluble bags.

Greenhouse Ornamentals (including flowers, shrubs, and trees)

Low-pressure handwand, handgun sprayer, high-pressure handwand

	WP

LC	0.00625 lbs ai/gallon

0.00938 lbs ai/gallon	

8

	14

14	Prohibit residential (consumer) hose-end sprayer applications in
greenhouses.

All wettable powder products must be packaged in water soluble bags.

Ornamentals (including flowers, shrubs and trees)

Low-pressure handwand, handgun sprayer, high-pressure handwand

Low-pressure handwand, chemigation, groundboom, high-pressure handwand

	LC

WP

DF	0.0023 lbs ai/gallon

0.0025 lbs ai/gallon	8

	14

14	Residential (consumer) use limited to ornamentals, only.

Professional hose-end sprayer applications are allowed.

All wettable powder products must be packaged in water soluble bags.

Ornamentals (including shade trees and woody shrubs)

Tree injection unit (ready-to-use micro injection unit, or unit
requiring product dilution)

	LC	0.000026 lbs ai/ inch of trunk circumference	6	NS

	Pines (including Christmas trees)

Low-pressure handwand and handgun sprayer

	LC	0.0023 lbs ai/gallon	8	14

	Pine Seed (on-nursery applications)

Dip

Planter box, hopper box, cement mixer,

Cement mixer

	WP

WP

DF	0.0000625 lbs ai/gallon

0.0013 lbs ai/A

0.00136 lbs ai/A	1

1

1	NR

NR

NR	All wettable powder products must be packaged in water soluble bags.

Pine Seed (commercial applications)

Commercial loading/applying, commercial bagging of treated seed,
commercial bag sewing, and multiple commercial activities

	WP	0.0013 lbs ai/lb	1	NR	All wettable powder products must be packaged
in water soluble bags.

Pine Seedlings

Aerial, flagging, airblast, groundboom, low-pressure handwand, handgun
sprayer

By hand	WP

Ready-to-use briquette	0.5 lbs ai/A

0.000019 lbs ai/seedling	4

1	NR

NR	A closed cockpit is required for aerial application.

All wettable powder products must be packaged in water soluble bags.

Roses

Low-pressure handwand, handgun sprayer, high-pressure handwand

	LC

WP	0.00029 lbs ai/gallon	8	14	All wettable powder products must be
packaged in water soluble bags.

Sod Farm Turf

Aerial, chemigation, flagging, groundboom, LCO handgun, low-pressure
handwand, and handgun sprayer

Aerial, flagging, tractor-drawn spreader

	WP

DF

G	2.7 lbs ai/A	2

(at max. single app. rate)	17	A closed cockpit is required for aerial
applications (all formulations).

A maximum annual application rate of 5.4 lbs ai/A is allowed.

All wettable powder products must be packaged in water soluble bags.

  SEQ CHAPTER \h \r 1 Appendix B.	Table of Generic Data Requirements
and Studies Used to Make the Reregistration Decision

	

GUIDE TO APPENDIX B

	Appendix B contains listing of data requirements which support the
reregistration for active ingredients within the case 2700 covered by
this RED/TRED.  It contains generic data requirements that apply to
triadimefon/triadimenol in all products, including data requirements for
which a "typical formulation" is the test substance.  

	The data table is organized in the following formats:

	1.	Data Requirement (Column 1).  The data requirements are listed in
the order in which they appear in 40 CFR part 158.  The reference
numbers accompanying each test refer to the test protocols set in the
Pesticide Assessment Guidance, which are available from the National
technical Information Service, 5285 Port Royal Road, Springfield, VA
22161 (703) 487-4650.

	2.	Use Pattern (Column 2).  This column indicates the use patterns for
which the data requirements apply.  The following letter designations
are used for the given use patterns.  

			A.	Terrestrial food

	 		B.	Terrestrial feed

			C.	Terrestrial non-food

			D.	Aquatic food

			E.	Aquatic non-food outdoor

			F.	Aquatic non-food industrial 

			G.	Aquatic non-food residential

			H. 	Greenhouse food

			I.	Greenhouse non-food

			J.	Forestry

			K.	Residential

			L.	Indoor food

			M.	Indoor non-food

			N.	Indoor medical

			O.	Indoor residential

	3.	Bibliographic Citation (Column 3).  If the Agency has acceptable
data in its files, this column list the identify number of each study. 
This normally is the Master Record	 Identification (MIRD) number, but
may be a "GS" number if no MRID number has been assigned.  Refer to the
Bibliography appendix for a complete citation of the study.

APPENDIX B-1

Data Supporting Guideline Requirements for the Reregistration of
Triadimefon

REQUIREMENT	USE PATTERN	CITATION(S)

                      PRODUCT CHEMISTRY

New Guideline Number	Old Guideline Number

	830.1550	61-1	Product Identity and Composition	All	CSF (’96)  SEQ
CHAPTER \h \r 1 

830.1600	61-2A	Start. Mat. & Mnfg. Process	All	00098119,   SEQ CHAPTER
\h \r 1 42307801

830.1620	61-2B	Description of Production Process	All	00098119, 42307801

830.1650	61-2B	Description of Formulation Process	All	00098119, 42307801

830.1670	61-2B	Formation of Impurities	All	40477401

830.1700	62-1	Preliminary Analysis	All	00098120, 44166001

830.1750	62-2	Certification of limits	All	44166001, CSF (’96)

830.1800	62-3  	Enforcement Analytical Method	All	42307802

830.6302	63-2	Color	All	41616001

830.6303	63-3	Physical State	All	41616001

830.6304	63-4	Odor	All	41616001

830.6313	63-13	Stability to Normal and Elevated Temperatures, Metals and
Metal Ions	All	42307803

830.6314	63-14	Oxidation/Reduction: Chemical Incompatibility	All	Not
Applicable; N/A 

830.6315	63-15	Flammability	All	N/A

830.6316	63-16	Explodability	All	N/A

830.6317	63-17	Storage Stability	All	N/A

830.6319	63-19	Miscibility	All	N/A

830.6320	63-20	Corrosion Characteristics	All	N/A

830.7000	63-12	pH	All	41616001

830.7050	None	UV/Visable Absorption	All	N/A

830.7100	63-18	Viscosity	All	41616001

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	  SEQ CHAPTER \h \r 1 Water solubility:  column elution
method; shake flask method	All	

41616001

830.7950	63-9	Vapor Pressure	All	42307801

ECOLOGICAL EFFECTS

850.2100	71-1	Avian Acute Oral Toxicity

00071469, 41895901

850.2200	71-2A	Avian Dietary Toxicity - Quail

00071469, 00050066

850.2200	71-2B	Avian Dietary Toxicity - Duck

00126277

850.2300	71-4	Avian Reproduction –Avian chronic tests on the Mallard
Duck and Bobwhite Quail

00110430, 00110431, 40283102, 42342301

850.2400	71-3	Mammal Acute/ Chronic Toxicity- Rat

00125411, 00151248, 00155075, 00264276, 92188019, 92188320

850.1010	72-2A	Invertebrate Toxicity

00071469, 00231311, 254693, 41922101

850.1025	72-3B	Estuarine/Marine Toxicity - Mollusk

Data Gap

850.1035

850.1045	72-3C	Estuarine/Marine Toxicity – Shrimp EC50

Data Gap

850.1075	72-3A	Estuarine/Marine Fish LC50

Data Gap

850.1075	72-1A	Fish Toxicity- Bluegill

00071469, 43304301

850.1075	72-1C	Fish Toxicity- Rainbow Trout

00071469, 43256201

850.1300	72-4A	Freshwater Fish- Early Life Stage

00251243, 41922103

850.1500	72-5 	Life Cycle Fish

N/A

850.1735	None	Freshwater Acute InvertebrateToxicity

00071469, 00231311, 00246736,  41922102 

850.4100	122-1A	Terrestrial Toxicity; Seedling Emergence

N/A

850.4150	122-1B	Terrestrial Plant Toxicity; Vegetative Vigor

N/A

850.5400	122-2	Aquatic Plant Growth 

00159558, 00266051

850.4225	123-1A	Seed Germination and Seedling Emergence (Tier 2)

Data Gap

850.4250	123-1B	Vegetative Vigor (Tier 2)

Data Gap

850.4400	123-2	Aquatic Vascular Plant Growth (Tier2)

Data Gap

850.3020	141-1	Honey Bee Acute Contact

05001991, 42307804

850.3030	141-2	Honey Bee Residue on Foliage

N/A

	          TOXICOLOGY

870.1100	81-1	Acute Oral Toxicity

00125411, 00264276, 43936101

870.1200	81-2	Acute Dermal Toxicity-Rat

00145086, 00264276

870.1300	81-3	Acute Inhalation Toxicity-Rat

41616002

870.2400	81-4	Primary Eye Irritation-Rabbit

41782501

870.2500	81-5	Primary Skin Irritation- Rabbit

41616004

870.2600	81-6	Dermal Sensitization- Guinea pig

41554001

870.6100	82-5A	90-Day Neurotoxicity- Hen

44153501

870.6300	83-6	Developmental Neurotoxicity Study

00089023; Data Gap 

870.3100	82-1A	90-Day Feeding - Rat

00048624

870.3100	82-1A	30-Day Oral Toxicity- Rat

00048627

870.3150	82-1B	90-Day Feeding (Non-rodent)- Dog

00048625, 00060226

870.3200	82-2	21-Day Dermal Toxicity- Rat

42341501

870.3700	83-3A	Developmental Toxicity - Rat

00089023, 00149336, 92188018

870.3700	83-3B	Developmental Toxicity - Rabbit

41446201, 42089601

870.3800	83-4	2-Generation Reproduction - Rat

00155075, 92188019, 92188020

The reproductive study in the rat is acceptable/ non-guideline in
conjunction with the 3-generation study (MRID 00032541)

870.3800	83-4	Reproduction and fertility effects (3-Gen)- Rat

00032541

The reproductive study in the rat is acceptable/ non-guideline 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 Battery-Rat

43495509, 43936101

870.6200	82-7	Subchronic Neurotoxicity Screening Battery- Rat

44153501

870.7485	85-1	General Metabolism- Rat

00033057, 42409101

OCCUPATIONAL/RESIDENTIAL EXPOSURE

875.2400	133-3	Dermal Passive Dosimetry Exposure

43125401

875.2500	133-4	Inhalation Passive Dosimetry Exposure

43125401

None	231	Estimation of Dermal Exposure at Outdoor Sites

45654503

None	232	Estimation of Inhalation Exposure at Outdoor Sites

45654503

ENVIRONMENTAL FATE

None	160-5	Chemical Identity

N/A

835.2120	161-1	Hydrolysis

41922101

835.2240	161-2	Photodegradation - Water

42112901

835.2410	161-3	Photodegradation - Soil

00044169, 42820401

835.2370	161-4	Photodegradation - Air

N/A

835.4100	162-1	Aerobic Soil Metabolism

42242701, 42224104, 41686102, 

835.4200	162-2	Anaerobic Soil Metabolism

41686101, 42401201

835.4400	162-3	Anaerobic Aquatic Metabolism

41686101, 42401201

835.4300	162-4	Aerobic Aquatic Metabolism

42224104

835.1240	163-1	Leaching/Adsorption/Desorption

41616008, 42356601

835.1410	163-2	Laboratory Volatilization

N/A

835.8100	163-3 	Volatility- Field

N/A

835.6100	164-1	Terrestrial Field Dissipation

42242701, 41686103, 41686104

835.6200	164-2	Aquatic Field Dissipation

N/A

835.6300	164-3	Forestry Dissipation

N/A

860.1950	165-4	Bioaccumulation in Fish

41619901

None	165-5	Bioaccumulation- Aquatic Nontarget

41619901

835-7100	166-1	Ground Water- Small Scale Prospective

N/A

840.1100	201-1	Spray Droplet Size Spectrum

N/A

840.1000	201-4	Background for Pesticide Aerial Drift (Evaluation)

N/A

840.1200	202-1	Spray Drift Field Deposition (Evaluation)

N/A

RESIDUE CHEMISTRY

860.1200	171-3	Directions for Use

N/A

860.1300	171-4A	Nature of Residue - Plants

42123401, 42123402, 42123403, 42798901, 42853401, 92188025-33

860.1300	171-4B	Nature of Residue - Livestock

42123404, 42856801, 42864901, 43418301-02, 92188034-39

860.1340	171-4C	Residue Analytical Method - Plants

43870101, 44041002, 92188040-43

860.1340	171-4D	Residue Analytical Method - Livestock

43418303, 92188044-48

860.1360	171-4M	Multiresidue Methods

41976601, 43705401

860.1380	171-4E	Storage Stability Data- Plant and Livestock

41976602, 42857401, 44038901, 44041001, 92188051-53, 43462401

860.1480	171-4J	Magnitude of Residues -Meat/Milk/Poultry /Egg

92188054-57

860.1500	171-4K	Crop Field Trials

92188060-65, 92188070, 92188073-75, 42342303-08,  41809401

860.1520	171-4L	Magnitude of Residue in Processed Food/Feed

42346601, 43948601, 92188064-65, 92188069, 43284401, 42013201, 92188074

860.1850	165-1	Confined Accumulation in Rotational Crops Study

42613301

860.1900	165-2	Field Accumulation in Rotational Crops Study

N/A

APPENDIX B-2

Data Supporting Guideline Requirements for the Reregistration of
Triadimenol

REQUIREMENT	USE PATTERN	CITATION(S)

                      PRODUCT CHEMISTRY

New Guideline Number	Old Guideline Number

	830.1550	61-1	Product Identity and Composition	All	N/A

830.1600	61-2A	Start. Mat. & Mnfg. Process	All	N/A

830.1620	61-2B	Description of Production Process	All	N/A

830.1650	61-2B	Description of Formulation Process	All	N/A

830.1670	61-2B	Formation of Impurities	All	N/A

830.1700	62-1	Preliminary Analysis	All	N/A

830.1750	62-2	Certification of limits	All	N/A

830.1800	62-3  	Enforcement Analytical Method	All	N/A

830.6302	63-2	Color	All	N/A

830.6303	63-3	Physical State	All	N/A

830.6304	63-4	Odor	All	N/A

830.6313	63-13	Stability to Normal and Elevated Temperatures, Metals and
Metal Ions	All	Data Gap 

830.6314	63-14	Oxidation/Reduction: Chemical Incompatibility	All	N/A

830.6315	63-15	Flammability	All	N/A

830.6316	63-16	Explodability	All	N/A

830.6317	63-17	Storage Stability	All	N/A

830.6319	63-19	Miscibility	All	N/A

830.6320	63-20	Corrosion Characteristics	All	N/A

830.7000	63-12	pH	All	Not available; Data Gap 

830.7050	None	UV/Visable Absorption	All	Not Available; Data Gap 

830.7100	63-18	Viscosity	All	N/A

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	  SEQ CHAPTER \h \r 1 Water solubility:  column elution
method; shake flask method	All	

00125399; Data Gap 

830.7950	63-9	Vapor Pressure	All	00125399

	          TOXICOLOGY

870.1100	81-1	Acute Oral Toxicity

00125411

870.1200	81-2	Acute Dermal Toxicity-Rat

00145086

870.1300	81-3	Acute Inhalation Toxicity-Rat

00145087

870.2400	81-4	Primary Eye Irritation-Rabbit

00145088

870.2500	81-5	Primary Skin Irritation- Rabbit

00145088

870.2600	81-6	Dermal Sensitization- Guinea pig

00125413

870.3100	82-1A	90-Day Oral Toxicity- Rat

00127769, 42192701

870.3150	82-1B	90-Day Oral Toxicity (Non-rodent )- Dog

00125420

870.3150	82-1B	6 months oral toxicity (Non-rodent)- Dog

00151247

870.3200	82-2	15-Day Dermal Toxicity- Rabbit

00151246

870.3465	82-4	21-Day Inhalation Toxicity- Rat

00125421

870.3700	83-3A	Prenatal Developmental Toxicity - Rat

40307804, 40887702, 41498401

870.3700	83-3B	Developmental Toxicity - Rabbit

40307805, 40887703, 42365001

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/Carcinogenicity- Rat

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 Effects- Mice

00145083

RESIDUE CHEMISTRY

860.1200	171-3	Directions for Use

N/A

860.1300	171-4A	Nature of Residue - Plants

42123401-03, 42798901, 42853401, 92188025-33

860.1300	171-4B	Nature of Residue - Livestock

42123404, 42856801, 42864901, 43418301-02, 92188034-39

860.1340	171-4C	Residue Analytical Method - Plants

43870101, 44041002, 92188040-43

860.1340	171-4D	Residue Analytical Method - Livestock

43418303, 92188044-48

860.1360	171-4M	Multiresidue Methods

40969801, 41976601, 43705401

860.1380	171-4E	Storage Stability Data- Plant and Livestock

41976602, 42857401, 44038901, 44041001, 92188051-53, 43462401

860.1480	171-4J	Magnitude of Residues -Meat/Milk/Poultry /Egg

92188054-57

860.1500	171-4K	Crop Field Trials

00125407-09, 40615201, 41051401, 41242801, 42696308-09, 42712101

860.1520	171-4L	Magnitude of Residue in Processed Food/Feed

44519801-03

860.1850	165-1	Confined Accumulation in Rotational Crops Study

42613301

860.1900	165-2	Field Accumulation in Rotational Crops Study

N/A

Appendix C.  Technical Support Documents

	Additional documentation in support of this RED is maintained in the
OPP docket, located in Room 119, Crystal Mall #2, 1801 South Bell
Street, Arlington, VA.  It is open Monday through Friday, excluding
Federal Holidays, from 8:30 am to 4 pm.

	The docket contains the risk assessments and related documents as of
August 30, 2006.  The availability announcement will be published in the
Federal Register.  All documents, in hard copy form, may be viewed in
the OPP docket room or downloaded or viewed via the internet at the
following site:   HYPERLINK
"http://www.epa.gov/pesticides/reregistration" 
www.epa.gov/pesticides/reregistration .  The following list details all
documents related to the Triadimefon/Triadimenol (RED/TRED).

Health Effects Documents:

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.

DP Barcode D314778.  Yvonne Barnes and Sheila Piper.  July 6, 2006. 
Triadimefon: Revised Acute, Probabilistic and Chronic Dietary (Food +
Drinking Water) Exposure and Risk Assessments for the Triadimefon
Reregistration.

DP Barcode D331455.  Yvonne Barnes and Sheila Piper.  August 1, 2006.
Triadimefon + Triadimenol:  Aggregate Acute, Chronic, and Short-Term
Risk Assessments Reflecting July, 2006 Risk Mitigation in Response to
the Phase 4 Triadimefon RED.

5.   	DP Barcode D328262.  Rich Griffin.    SEQ CHAPTER \h \r 1 June 20,
2006.  Triadimefon:  HED Response to Comments Received During the Public
Comment Phase.

6.	DP Barcode D330611.  Rich Griffin.  July 10, 2006. 
Triadimefon/Triadimenol: Summary of Refinements and Revisions to the
Human Health Risk Assessment.

7.	DP Barcode D314814 and D315040.  Shanna Recore.  June 30, 2006.
Triadimefon: Occupational and Residential Exposure Assessment for the
Reregistration Eligibility Decision Document.

8.	Meeting Summary.  Kimberly Nesci.  EPA/FDA Joint Teleconfernce on
July 11, 2006 to Discuss 1,2,4 Triazole (Free Triazole) as a Common
Metabolite of Triazole Derivative Fungicides and Anastrozole, a Drug. 

 Sam Ary.  Triadimefon. Acute and Chronic Dietary Exposure Assessments
for the Reregistration Eligibility Decision (RED) Document.

10.	 DP Barcode D321636.  Sam Ary.  August 31, 2005.  Triadimefon.
Registrants Response to Residue Chemistry Data Requirements.  Magnitude
of Triadimefon Residues of Concern in Apple Processed Commodities.

11.	 DP Barcode D314778.  Sam Ary.  November 23, 2005.  Triadimefon. 
Acute and Chronic Dietary Exposure Assessments for the Reregistration
Eligibility Decision (RED) Document.

12.	 DP Barcode D315115.  Yvonne Barnes.  November 22, 2005. 
Triadimefon: 	 Summary of Product Chemistry Data for Reregistration
Eligibility Decision 	 (RED) Document.

13.	 DP Barcode D 326678.  Rich Griffin.  February 9, 2006. 
Triadimefon. 	 	 Preliminary Human Health Risk Assessment (Revised). 

14.	 DP Barcode D314742.  Sam Ary.  November 23, 2005.  Triadimefon. 
Summary of Analytical Chemistry and Residue Data for the Reregistration
Eligibility Decision (RED) Document.

15.	 DP Barcode D314928.  Sam Ary.  November 18, 2005.  Triadimenol
Acute 	 and Chronic Dietary Exposure Assessments for the Tolerance
Reassessment 	 Eligibility Decision Document.

16.	 DP Barcode D314891.  Sam Ary.  November 17, 2005.  Triadimenol. 	 	
Summary of Analytical Chemistry and Residue Data for the Tolerance 	 	
Reassessment Eligibility Decision Document.

 DP Barcode D326716.  Christina Jarvis.  January 24, 2006.  Triadimenol
HED Chapter of the Tolerance Reassessment Eligibility Decision Document 
  (Revised).

 DP Barcode D322336.  Sam Ary.  October 14, 2005.  Triadimenol.  
Registrants Response to Residue Chemistry Data Requirements.

 DP Barcode D315152.  Yvonne Barnes.  November 22, 2005.  Summary of
Product Chemistry Data for Tolerance Reassessment Document.

 DP Barcode D322240.  Jack Arthur.  December 9, 2005.  Occupational and
Residential Exposure/Risk Assessment of 1,2,4-Triazole.

 DP Barcode D 322238.  Michael Doherty.  November 1, 2005. 
1,2,4-Triazole. Acute and Chronic Dietary Exposure Assessments to
Support Reregistration and Registration Actions for Triazole-derivative
Fungicides.

 DP Barcode D322239.  Michael Doherty.  December 20, 2005.  Triazole
Alanine and Triazole Acetic Acid.  Acute and Chronic Dietary Exposure
Assessments to Support Reregistration and Registration Actions for
Triazole-derivative Fungicides.

 DP Barcode D322215.  Michael Doherty.  February 7, 2006. 
1,2,4-Triazole, Triazole Alanine, triazole Acetic Acid:  Human Health
Aggregate Risk Assessment in Support of Reregistration and Registration
Actions for Triazole-derivative Fungicide Compounds.

  Kathleen Raffaele.  Triazoles- 2nd Report of the Ad Hoc HED Peer
Review Committee.  

Ecological Fate and Effects Documents:

DP Barcode D328531.  Fred Jenkins and Jonathan Angier.  June 1, 2006. 
Response to Bayer Public Comments Regarding the Environmental Fate and
Effects Division Triadimefon Risk Assessment.

DP Barcode D 331725.  Fred Jenkins and Jonathan Angier.  August 3, 2006.
 EFED Revisions to the Ecological Risk Assessment (dated Aug. 30, 2005)
and the Drinking Water Exposure Assessment (dated Aug. 31, 2005) in
Support of the Triadimefon Reregistration Eligibility Decision Document.

	DP Barcode D316941.  Jonathan Angier.  August 31, 2005.  Tier 2
Drinking 	Water Assessment for Triadimefon and its Major Degradate
Triadimenol.

	Jonathan Angier and Michelle Embry.  January 19, 2006.  Environmental
Fate 	and Ecological Risk Assessment for Triadimefon.

	DP Barcode D312519.  James Breithaupt.  February 9, 2005.  TRED for 
Triadimenol; Drinking Water Assessment.

	6.	DP Barcode D329271.  James Hetrick.  June 15, 2006. Response to
Triazole 		Task Force Comments on the FQPA Drinking Water Assessment for
1,2,4-		Triazole (1,2,4-T), Triazole alanine (TA), and Triazole acetic
acid (TAA).

 

Other Documents:

	1.	Memorandum.  John A. Lazor.  EPA 1,2,4 Triazole Consult Response.  
Appendix D.  Citations Considered to be Part of the Data Base
Supporting the Reregistration Eligibility Decision (Bibliography) for
Triadimefon and Triadimenol

Bibliography

MRID	Citation Reference

32539	Hoffman, K.; Groning, P. (1978) Meb 6447 Long-Term Toxicity Study
on Dogs (Two-Year Feeding Study): Report No. 7882; Report No. 66656.
(Unpublished study received Apr 28, 1980 under 3125- 318; prepared by
Bayer, AG, submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:099413-D) 

32541	Loser, E.; Lorke, D. (1979) Meb 6447 Multigeneration Reproduction
Study on Rats: Report No. 8297; Report No. 67752. (Unpublished study
received Apr 28, 1980 under 3125-318; prepared by Bayer, AG, submitted
by Mobay Chemical Corp., Kansas City, Mo.; CDL: 099413-F) 

33057	Fredrickson, D.R. (1978) Metabolism of Bayleton^(TM)I in Rats: Re-
port No. 66201. (Unpublished study received Apr 28, 1980 under 3125-318;
submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:099415-F) 

48624	Mohr, U. (1976) Meb 6447: Subchronic Toxicity Study on Rats
(Twelve -Week Feeding Experiment): Report No. R 840 a; Report No. 44300.
(Unpublished study received Aug 15, 1977 under 3125-318; pre- pared by
Medizinische Hochschule Hannover, Abteilung fur Experi- mentelle
Pathologie, West Germany, submitted by Mobay Chemical Corp., Kansas
City, Mo.; CDL:231312-C) 

48625	Hoffman, K.; Luckhaus, G. (1974) Meb 6447: Subchronic Toxicity
Study on Dogs (Thirteen-Week Feeding Experiment): Report No. 5071;
Report No. 44737. (Unpublished study received Aug 15, 1977 under
3125-318; prepared by Bayer, AG, submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL:231312-D) 

48627	Thyssen, J.; Kimmerle, G.; Luckhaus, G. (1974) Meb 6447: Subacute
Toxicity Studies: Report No. 4464; Report No. 46338. (Unpub- lished
study received Aug 15, 1977 under 3125-318; prepared by Bayer, AG,
submitted by Mobay Chemical Corp.; Kansas City, Mo.; CDL:231312-F) 

48628	Machemer, L. (1976) Meb 6447: Dominant Lethal Study on Male Mice
to Test for Mutagenic Effects: Report No. 5837; Report No. 47929.
(Unpublished study received Aug 15, 1977 under 3125-318; pre- pared by
Bayer, AG, submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:231312-G) 

48637	Machemer, L. (1977) MEB 6447 (Triadimefon, Bayleton Active Ingre-
dient): Micronucleus Test on Mice to Evaluate Meb 6447 for Muta- genic
Effects: Report No. 6622; Report No. 52724. (Unpublished study received
Aug 15, 1977 under 3125-318; prepared by Bayer, AG, submitted by Mobay
Chemical Corp., Kansas City, Mo.; CDL: 231312-P) 

50066	Fink, R.; Beavers, J.B. (1977) Final Report: Eight-Day Dietary
LC50--Bobwhite Quail: Project No. 149-105; Report No. 527773.
(Unpublished study received Aug 15, 1977 under 3125-318; pre- pared by
Wildlife International, Ltd., submitted by Mobay Chemi- cal Corp.,
Kansas City, Mo.; CDL:231311-K) 

60226	Hoffmann, K.; Luckhaus, G.; Lorke, D. (1974) Meb 6447: Subchronic
Toxicity Study on Dogs (Thirteen-Week Feeding Experiment): Re- port
No.5071; Report No. 44737. (Unpublished study received Dec 15, 1977
under 3125-EX-149; prepared by Bayer, AG, W. Germany, submitted by Mobay
Chemical Corp., Kansas City, Mo.; CDL: 232490-D) 

71469	Mobay Chemical Corporation Agricultural Chemicals Division;
Environmental Toxicology of Baytan (Triadimenol); KWG 0519; October 29,
1982.

89023	Nagumo, K.; Teraki, Y.; Chiba, T.; et al. (1981) Teratogenicity
Test of MEB 6447 in Pregnant Rats: ?Submitter| 80257. (Unpub- lished
study received Jan 5, 1982 under 1F2474; prepared by St. Marianna Univ.,
First Dept. of Anatomy, Laboratory of Embry- ology, submitted by Mobay
Chemical Corp., Kansas City, Mo.; CDL: 070570-A) 

98119	Smith, D.N. (1981) Bayleton Manufacture. (Unpublished study re-
ceived Mar 30, 1982 under 2F2665; submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL:070747-A) 

98120	Harbin, D.N.; Slahck, S.C.; Westphal, C. (1982) The Composition of
Technical ^(R)IBayleton: Report No. 80605. (Unpublished study received
Mar 30, 1982 under 2F2665; submitted by Mobay Chemical Corp., Kansas
City, Mo.; CDL:070747-B) 

110430	Mobay Chemical Corp. (1982) Synopsis of Environmental Toxicology
of Bayleton. Summary of studies 248117-B through 248117-E. (Unpublished
study received Aug 17, 1982 under 3125-318; CDL: 248117-A) 

110431	Lamb, D.; Carsel, M.; Mallicoat, D.; et al. (1982) Triadimefon
(Bayleton) Reproduction Study with Bobwhite Quail: Study No. 81- 675-03;
80753. (Unpublished study received Aug 17, 1982 under 3125-318;
submitted by Mobay Chemical Corp., Kansas City, MO; CDL:248117-B) 

125399	Mobay Chemical Corp. (1983) Product Chemistry of Baytan. (Compi-
lation; unpublished study received Mar 11, 1983 under 3125-346;
CDL:071461-A) 

125411	Mihail, F.; Thyssen, J.; Lorke, D. (1980) KWG 0519 (Triadimenol):
Acute Toxicity Studies--(Isomer Ratio 80:20): Bayer Report No. 9451;
69378. (Unpublished study received Mar 11, 1983 under 3125-346; prepared
by Farbenfabriken Bayer, AG, W. Ger., submitted by Mobay Chemical Corp.,
Kansas City, MO; CDL: 071466-B) 

125421	Kimmerle, G.; Lorke, D. (1976) KWG 0519: Subacute Inhalation
Toxicity Study on Rats: Report No. 6321; 51130. (Unpublished study
received Mar 11, 1983 under 3125-346; prepared by Farben- fabriken
Bayer, AG, W. Ger., submitted by Mobay Chemical Corp., Kansas City, MO;
CDL:071466-M) 

126259	Bomhard, E.; Loser, E.; Frank; et al. (1982) KWG 0519
(Triadimenol, Baytan Active Ingredient): Chronic Toxicological Study on
Mice (Feeding Experiment over Two Years): Report No. 10855- 82291.
(Unpublished study received Mar 11, 1983 under 3125- 346; prepared by
Farbenfabriken Bayer, AG, W. Ger., submitted by Mobay Chemical Corp.,
Kansas City, MO; CDL:071467-A) 

126260	Kroetlinger, F.; Loeser, E.; Schilde, B.; et al. (1982) KWG 0519:
(Triadimenol, the Active Ingredient of Baytan): Chronic Toxicity Study
on Rats (2-year Feeding Experiment): Bayer Report No. 11009; 82358.
(Unpublished study received Mar 11, 1983 under 3125-346; prepared by
Bayer AG, W. Ger., submitted by Mobay Chemical Corp., Kansas City, MO;
CDL:071468-A) 

126261	Hoffmann, K.; Groning, P.; Lorke, D. (1978) MEB 6447: Long-term
Toxicity Study on Dogs (Two-year Feeding Study): Report No. 7882; 66656.
(Unpublished study received Mar 11, 1983 under 3125-346; prepared by
Bayer AG, W. Ger., submitted by Mobay Chemical Corp., Kansas City, MO;
CDL:071468-B) 

126264	Herbold, B.; Lorke, D. (1979) KWG 0519: Salmonella/Microsome Test
for Detection of Point-mutagenic Effects: Report No. 8189; 67595.
(Unpublished study received Mar 11, 1983 under 3125-346; prepared by
Bayer AG, W. Ger., submitted by Mobay Chemical Corp., Kansas City, MO;
CDL:071468-F) 

126266	Herbold, B.; Lorke, D. (1978) KWG 0519: Dominant Lethal Study on
Male Mouse to Test for Mutagenic Effects: Report No. 7900; 66746.
(Unpublished study received Mar 11, 1983 under 3125-346; prepared by
Bayer AG, W. Ger., submitted by Mobay Chemical Corp., Kansas City, MO;
CDL:071468-H) 

126269	Cifone, M.; Balinas, V. (1982) Mutagenicity Evaluation of KWG
0519 in the Mouse Lymphoma Forward-mutation Assay: LBI Safety No. 7607;
82353. Final rept. (Unpublished study received Mar 11, 1983 under
3125-346; prepared by Litton Bionetics, Inc., submitted by Mobay
Chemical Corp., Kansas City, MO; CDL: 071468-K) 

126271	Herbold, B.; Lorke, D. (1981) KWG 0519: Triadimenol, the Active
Ingredient of Baytan: Study of DNA Damage Using the E. coli Pol Al-
Test: Bayer Report No. 10265; 80212. (Unpublished study received Mar 11,
1983 under 3125-346; prepared by Bayer AG, W. Ger., submitted by Mobay
Chemical Corp., Kansas City, MO; CDL:071468-M) 

126277	Lamb, D.; Toll, P.; Mallicoat, D.; et al. (1981) Acute Dietary
LC50 of Technical Triadimenol (Baytan) to Mallard Ducks and Bobwhite
Quail: Study No. 80-175-09 and 80-175-05. (Unpublished study received
Mar 11, 1983 under 3125-346; submitted by Mobay Chemical Corp., Kansas
City, MO; CDL:071469-F) 

145083	Polacek, I. (1983) Central Nervous Effects of KWG 0519 (Pilot
Study): Study No. 03018. Unpublished study prepared by Toxicol- ogical
Institute Regensburg. 17 p. 

145086	Hixson, E. (1983) Acute Dermal Toxicity of Baytan 25% Dry
Flowable in Rabbits: Study Number 83-023-05. Unpublished study prepared
by Mobay Chemical Corporation. 11 p. 

145087	Sangha, G. (1983) Acute Inhalation Toxicity Study with Baytan 25%
Dry Flowable in Rats: Study Number 83-041-08. Unpublished study prepared
by Mobay Chemical Corporation. 16 p. 

145088	Hixson, E. (1984) Eye and Dermal Irritation of Baytan 25% Dry
Flowable in Rabbits: Study Numbers 83-323-06 and 83-333-06. Unpublished
study prepared by Mobay Chemical Corporation. 16 p. 

149331	Mihail, F. (1980) MEB 6447: Acute Toxicity Studies: Report No.
9277. Unpublished study prepared by Bayer AG. 10 p. 

149336	Unger, T.; Van Goethem, D.; Shellenberger, T. (1982) A Terato-
logical Evaluation of Bayleton in Mated Female Rats: MRI Project No.
7272-B. Unpublished study prepared by Midwest Research Institute. 52 p. 

      150484		Hoffmann, K.; Vogel, O. (1984) KWG 0519 (C.N. Triadimenol)
First Chronic Study of Toxicity to Dogs on Oral Administration (Two-
year Feeding Study): KWG 0519/005. Unpublished study prepared by Bayer
AG. 254 p. 

151246	Heimann, K.; Schilde, B. (1984) KWG 0519 (Suggested Common Name:
Triadimenol, the Active Ingredient of BAYTAN): Subacute Dermal Toxicity
Study on Rabbits: Bayer Report No.: 12496. Unpublished study prepared by
Bayer AG. 66 p. 

151247	Hoffmann, K. (1984) KWG 0519 (c.n. Triadimenol): Second Chronic
Study of Toxicity to Dogs on Oral Administration (Six-month Feeding
Study): Report No.: 12971. Unpublished study prepared by Bayer AG. 127
p. 

151248	Loeser, E.; Eiben, R. (1984) KWG 0519 (Proposed c.n.
Triadimenol): Generation Study on Rats: Report No.: 12390. Unpublished
study prepared by Bayer AG. 250 p. 

155075	Eiben, R. (1984) MEB 6447 (Triadimefon): Two-generation Study
with Rats: Supplementary Study: Report No. 12712. Unpublished study
prepared by Bayer AG, Institute of Toxicology. 168 p. 

159012	Hoffmann, K. (1984) Investigation of the Body Weight Development
of Beagle Dogs in Chronic Toxicity Studies (Survey, 1973-1983): Pharma
Report No. 12385. Unpublished study prepared by Bayer Pharmaceuticals
Div. 14 p. 

159343	Herbold, B. (1985) MEB 6447 C.N. Triadimefon: Pol Test on E. coli
To Evaluate for Potential DNA Damage: Revised Report: Report No. 12780.
Unpublished translation, Mobay report no. 86793, of study prepared by
Bayer AG. 16 p. 

159558	Heimbach, F. (1985) Growth Inhibition of Green Algae (Scenedesmus
subspicatus) by Triadimefon (Technical): Test Report: Report HBF/A112:
Study No. A105/85. Unpublished study prepared by Bayer AG. 18 p. 

231311	Chemagro Agricultural Division, Bayleton Fish and Wildlife
Safety, June, 18 1977.

246736	Mobay Chemical Corporation, Corporate Toxicology Department,
Stanley

Life Cycle Study of Triadimefon to Daphnia Magna; Research Center; Study
Number 81--667-01 Author: D. W. Lang.

251243	Mobay Chemical Corporation, Toxicity of Triadimefon (Bayleton) To
Rainbow Trout Early Life Stages; Report No. 85939 September 9, 1983.

254693	Mobay Chemical Corporation, Bayleton Fish and Wildlife Data,
Brochure, confidential 

document number AS 84-2461; September, 1984.

264276	Mobay Corporation Environmental Health Research;Toxicology of
Bayleton; 

Supplement No. 5 to Original Brochure Date June 6, 1977; Brochure No.
1441; February 21, 1986.

266051	Bayer AG, 1986, Influence of KWG 0519 on the Growth of Green
Algae in Nutrient Solution, Report No. 82684

5001991	Stevenson, J. H.; The Acute Toxicity of Unformulated Pesticides
to Worker Honey

Bees; Rothamsted Experimental Station Harpenden New Hampshire.

40283102	Mobay Corporation Coroporate Toxicology Department; Effect of 

Triadimenol (Baytan) of Mallard Duck Reproduction; Report No. 86385;
February 28, 1984;  Report Author: J.C. Carlisle.

40307804	Becker, H. (1987) Embryotoxicity (including Teratogenicity)
Study with KWG 0519 in the Rat: Report No. 94463. Unpublished compil-
ation prepared by Research and Consulting Co. AG. 494 p. 

40307805	Becker, H.; Mueller, E.; Vogel, W.; et al. (1987)
Embryotoxicity (including Teratoegenicity) Study with KWG 0519 in the
Rabbit: Project 065248: Report No. 94762. Unpublished compilation pre-
pared by Research and Consulting Co. AG. 318 p. 

40477401	Talbott, T. (1987) Supplement 1: Product Chemistry of Bayleton
Technical: Laboratory Project ID ANR-00587. Unpublished study prepared
by Mobay Corporation. 55 p. 

40615201	Pither, K. (1988) Triadimenol--Magnitude of Residues on
Bananas: Baytan Objective No. 5781. Unpublished study prepared by PTRL.
86 p. 

40752101	Bomhard, E. (1986) MEB 6447: Carcinogenicity Study on NMRI Mice
(21-Month Administration in the Feed): Report No. 87287. Unpu- blished
study prepared by Bayer AG. 1190 p. 

40819101	Nagata, T. (1981) Triadimefon Subacute Toxicity on Rats:
3-Month Feeding Study: Report No. 69700. Unpublished study prepared by
Shin Nippon Kagaku Co., Ltd. 229 p. 

40865101	Bombard, E.; Hahnemann, S. (1986) MEB 6447: Common Name:
Triadime- fon, the Active Ingredient of Bayleton: Carcinogenicity Study
on NMRI Mice: Project ID 87287. Unpublished study prepared by Bayer Ag.
5 p. 

40887702	Becker, H. (1987) Embryotoxicity (Including Teratogenicity)
Study with KWG 0519 in the Rat: Project ID 94463. Unpublished study
prepared by Research and Consulting Co. 13 p. 

40887703	Becker, H. (1987) Embryotoxicity (Including Teratogenicity)
Study with KWG 0519 in the Rabbit: Project ID 94762. Unpublished stu- dy
prepared by Research and Consulting Co. AG. 9 p. 

40969801	Foushee, G. (1988) Baytan, Multiresidue Method Trial: Project
ID; 87-4705; Mobay Report No. 95672. Unpublished study prepared by
Langston Laboratory, Inc. 526 p. 

41051401	Pither, K. (1989) Triadimenol--Magnitude of Residues on
Bananas: Baytan Objective No. 5781: Mobay Report No. 95684-1.
Unpublished study prepared by PTRL. 11 p. 

41242801	Rockwell, J. (1988) Residues of Baytan and Its Metabolites in
Cotton: Morse Laboratories 45659, 45661. Unpublished study pre- pared by
Morse Laboratories. 354 p. 

41446201	Clemens, G.; Hartnagel, R. (1990) Teratology Study in the
Rabbit with MEB 6447 (Triadimefon): Report No.: MTD0149. Unpublished
study prepared by Miles, Inc. 155 p. 

41498401	Clemens, G.; Troup, C.; Hartnagel, R. (1990) Developmental
Toxicity Study in the Rat with Baytan Technical: Report No.: MTD0156.
Unpublished study prepared by Miles, Inc., Toxicology Depart- ment. 263
p. 

41554001	Sheets, L. (1990) Dermal Sensitization Study with Technical
Grade Triadimefon (Bayleton) in Guinea Pigs: Lab Project Number:
90-324-EL. Unpublished study prepared by Mobay Corp. 21 p. 

41616001	Talbot, T. (1990) Product Chemistry of Bayleton Technical:
Supple- ment 1: Lab Project Number: 80298; 85997; 91321. Unpublished
study prepared by Mobay Corp. 25 p. 

41616002	Warren, D. (1990) Acute Four-Hour Inhalation Toxicity Study
with Bayleton Technical in Rats: Lab Project Number: 90-042-GL. Un-
published study prepared by Mobay Corp. 31 p. 

41616004	Sheets, L. (1990) Primary Dermal Irritation Study with
Technical Grade Triadimefon (Bayleton) in Rabbits: Lab Project Number:
90-325-EK. Unpublished study prepared by Mobay Corp. 16 p. 

41616008	Daly, D. (1987) Soil Adsorption/Desorption with ?carbon 14|-
Bayleton: Final Report: Lab Project Number: 36354. Unpublished study
prepared by Analytical Bio-Chemistry Laboratories, Inc. 50 p. 

41619901	Grau, R. (1990) Triadimefon: Bioconcentration in Fish: Lab
Project Number: E2880381/0. Unpublished study prepared by Mobay Corp. 55
p. 

41686101	Leimkuehler, W.; Lenz, C. (1989) The Anaerobic Soil Metabolism
of ?Triazole-3,5 carbon 14| Triadimefon 1: Lab Project Number: BL0-
42102. Unpublished study prepared by Mobay Corp. 33 p. 

41686102	Leimkuehler, W.; Lenz, C.; Stevenson, T. et al. (1989) The
Aerobic Metabolism of ?Triazole-3,5, carbon 14| Triadimenfon1: Lab Pro-
ject Number: BL042101. Unpublished study prepared by Mobay Corp. 42 p. 

41686103	Carey, R. (1990) Subsurface Soil Investigation Report: Lab
Project Number: ML022101. Unpublished study prepared by Mobay Corp. 44
p. 

41686104	Carey, R. (1990) Subsurface Soil Investigation Report: Lab
Project Number: ML022101. Unpublished study prepared by Mobay Corp. 72
p. 

41782501	Sheets, L. (1990) Primary Eye Irritation Study with Bayleton
50% WP in Rabbits: Lab Project Number: 90-335-GY. Unpublished study
prepared by Mobay Corporation 18 p. 

41809401	Williams, B. (1991) Triadimefon: Magnitude of the Residue Crop
Field Trials: Lab Project Number: 38613-1: BL19GR01: 100122. Unpublished
study prepared by Analytical Bio-Chemistry Laborato- ries Inc. 323 p. 

41895901	Stafford, T. (1991) Technical Bayleton: An Acute Oral LD50 with
Bobwhite Quail (Colinus virginianus): Lab Project Number: BL711- 701:
101222. Unpublished study prepared by Mobay Corp. 21 p. 

41922101	Cain, K.; Moore, K. (1991) Stability of Triadimefon in Sterile
Aqueous Buffer Solutions: Lab Project Number: BL072401: 101291.
Unpublished study prepared by Mobay Corp. 26 p. 

41922102	Gagliano, G. (1991) Chronic Toxicity of Bayleton Technical to
the Waterflea (Daphnia magna) Under Static Renewal Conditions: Lab
Project Number: BL840701: 101298. Unpublished study prepared by Mobay
Corp. 57 p. 

41922103	Cohle, P.; Friesen, K. (1991) Early Life-Stage Toxicity of
Bayleton to Fathead Minnows (Pimephal-es promelas) in a Flow-through
Sys- tems: Lab Project Number: 39006: 101301. Unpublished study pre-
pared by ABC Laboratories, Inc. 75 p. 

41976601	Ver Hey, M. (1991) Bayleton, KWG 1323 and KWG 1342:
Multiresidue Method Testing: Lab Project Number: MOBAY/1093: BL161601.
Un- published study prepared by Colorado Analytical Research & Dev.,
Corp. 380 p. 

41976602	Williams, B.; Conrath, B. (1991) Triadimefon/Triadimenol
Freezer Storage Stability Study in Wheat Gain, Grapes, and Tomatoes:
Amended Report: Lab Project Number: 36987-1: BL142301: 100105.
Unpublished study prepared by Analytical Bio-Chemistry Labora- tories.
417 p. 

42013201	Pither, K. (1991) Triademefon (500DF): Magnitude of the Residue
on Pineapple Processed Products: Lab Project Number: BL19PN02B: 101325.
Unpublished study prepared by ABC Labs, Inc. and Maui Pineapple Company,
Ltd. 324 p. 

42089601	Clemens, G.; Hartnagel, R. (1991) Teratology Study in the
Rabbit with MEB 6447: Supplement to MRID 41446201: Lab Project Number:
100026: MTD0149. Unpublished study prepared by Miles, Inc., Tox. Dept.
11 p. 

42112901	Krolski, M.; Bosnak, L. (1991) Addendum I: Additional
Characteriza- tion of the Degradation Products Found in the Triadimefon
Aqueous Photolysis Study: Lab Project Number: 101357: BL082402.
Unpublished study prepared by Mobay Corp. 25 p. 

42123401	Krolski, M. (1991) Addendum I: Raw Data on the Fate of ?carbon
14| Triadimefon on Tomatoes and Cucumbers: Lab Project Number: 68593 -1.
Unpublished study prepared by Stoner Labs, Inc. 20 p. 

42123402	Minor, R. (1991) Addendum I: Raw Data for the Metabolism of
Triadim efon in Apples: Lab Project Number: 53621-1. Unpublished study
prepared by Mobay Corp. 19 p. 

42123403	Duah, F. (1991) Addendum I: Raw Data on The Metabolism of
Bayleton on Grapes: Lab Project Number: 88790-1. Unpublished study pre-
pared by Mobay Corp. 27 p. 

42123404	Chopade, H. (1991) Addendum I: Raw Data for the Metabolism of
Triad imefon in Male and Female Pigs: Lab Project Number: 66509-1. 51 p.

42153901	Bomhard, E.; Schilde, B. (1991) MEB 6447: Chronic Toxicity and
Cancerogenicity Studies on Wistar Rats with Administration in Diet over
a Period of 105 Weeks: Lab Project Number: 20774: 101922. Unpublished
study prepared by Bayer Ag., Dept. of Toxicology. 1029 p. 

42192701	Nishimura, N. (1983) Subacute Toxicity Study of KWG 0519 in
Dietary Administration to Rats for 13 Weeks: Lab Project Num- ber:
101939. Unpublished study prepared by Bozo Research Cent- er Inc. 320 p.

42224104	Leikmuehler, W.; Lenz, C.; Stevenson, T.; et al. (1989) The
Aerobic Metabolism of (Triazole-3,5-carbon 14) Triadimenfon (sic): Lab
Project Number: BLO42101: 99773. Unpublished study prepared by Mobay
Corp. 45 p. 

42242701	Grace, T.; Cain, K. (1991) Dissipation of Triadimefon in
California Soils: Revised: Lab Project Number: 100150: BL830089R0A:
892010.1-1K. Unpublished study prepared by Plant Science, Inc., Siemer
and Associates, Inc., and Ricerca, Inc. 4388 p. 

42307801	Fontaine, L. (1992) Supplemental Product Chemistry of Bayleton
Technical: Lab Project Number: MCL0054. Unpublished study prepared by
Miles, Inc. 22 p. 

42307802	Fontaine, L. (1992) Supplemental Product Chemistry of Bayleton
Technical: Lab Project Number: ANR-00692: ANR-00792. Unpublished study
prepared by Miles, Inc. 20 p. 

42307803	Fontaine, L. (1992) Supplemental Product Chemistry of Bayleton
Technical: Lab Project Number: 52834: 68665: 85997. Unpublished study
prepared by Miles, Inc. 41 p. 

42307804	Hoxter, K.; Lynn, S. (1992) Technical Bayleton: An Acute
Contact Toxicity Study with the Honey Bee (LD50): Lab Project Number:
149-168B: BL761401: 102633. Unpublished study prepared by Wildlife
Intl., Inc. 18 p. 

42341501	Sheets, L.; Phillips, S.; Lake, S. (1992) A Repeated Dose
21-Day Dermal Toxicity Study with Technical Grade Triadimefon (Bayleton)
in Rats: Lab Project Number: 91-122-LE; 102680. Unpublished study
prepared by Miles, Inc. 215 p. 

42342301	Stafford, T. (1992) Technical Bayleton: A One Generation
Reproduction Study with Bobwhite Quail: Lab Project Number: BL741701.
Unpublished study prepared by Miles, 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. 

42342308	Burger, R. (1992) Triadimefon (50DF)--Magnitude of the Residue
on Summer Squash: Lab Project Number: BL 19SQ01: 39589: 102629.
Unpublished study prepared by Miles, Inc. and ABC Laboratories. 420 p. 

42346601	Burger, R. (1992) Triadimefon (50DF)-Magnitude of the Residue
on Processed Apple Commodities: Lab Project Number: BL-19AP02: 39591:
102636. Unpublished study prepared by Miles Inc. and ABC Laboratories.
233 p. 

42356601	Cain, K.; Green, D. (1992) Leaching of Aged Residues of
Triadimefon: Lab Project Number: BL092101: 102631. Unpublished study
prepared by Miles Inc. 33 p. 

42365001	Clemens, G.; Grosso, D.; Anderson, E.; et al. (1992) A
Developmental Toxicity Study in Rabbits with Baytan Technical: Lab
Project Number: MTD0256: 102692. Unpublished study prepared by Miles,
Inc. 159 p. 

42401201	Schmidt, J.; Head, L. (1992) Anaerobic Aquatic Metabolism of
?carbon-14| Triadimefon: Lab Project Number: BLO42401: 103207: 392331.
Unpublished study prepared by ABC Labs, Inc. 60 p. 

42409101	Chopade, H. (1992) Disposition and Metabolism of
?Phenyl-UL-carbon 14| Triadimefon in Rats: Lab Project Number: BLO41801:
102640. Unpublished study prepared by Miles, Inc. 251 p. 

42613301	Mattern, G.; Parker, G.; Wendt, S. (1992) Confined Accumulation
of (Phenyl-UL-(carbon 14)) Triadimefon Residues in Rotational Crops: Lab
Project Number: BL051601: 91.027: P309W: 103806. Unpublished study
prepared by Miles Inc., Plant Sciences, Inc. and PTRL West, Inc. 152 p. 

42696308	Williams, B. (1992) Triadimenol--Magnitude of the Residue on
Barley, 2.6F ST: Amended Final Report: Lab Project Number: 38700-1:
BT19BA01: 100351. Unpublished study prepared by ABC Laboratory. 410 p. 

42696309	Williams, B. (1992) Triadimenol--Magnitude of the Residue on
Oats, 2.6F ST: Amended Final Report: Lab Project Number: 388151:
BT19OA01: 100352. Unpublished study prepared by ABC Laboratories, Inc.
368 p. 

42712101	Williams, B. (1992) Triadimenol--Magnitude of the Residue on
Wheat, 2.6F ST. Unpublished study prepared by ABC Laboratories, Inc. 432
p. 

42798901	Krolski, M. (1993) Fate of Bayleton-(carbon 14) as a 25 Percent
Wettable Powder on Tomatoes and Cucumbers. Mass Spectral Data on (carbon
14) Triadimefon Residues. 

42853401	Chopade, H. (1993) Metabolism of (Phenyl-UL-(carbon 14))
Triadimefon in Wheat: Lab Project Number: BL041601: 105162. Unpublished
study prepared by Miles Inc., Agricultural Div. 141 p. 

42856801	Hall, L.; Hartz, A. (1993) The Metabolism of (carbon 14)
Triadimefon in the Lactating Goat: Lab Project Number: BL041001: 105161.
Unpublished study prepared by Miles Inc. 160 p. 

42857401	Williams, B.; Chickering, C. (1993) Triadimefon and
Metabolites--Freezer Storage Stability Study in Raw Agricultural
Commodities and Processed Products: Lab Project Number: 396832:
BL131601: 102641-1. Unpublished study prepared by ABC Labs, Inc. 150 p. 

42864901	Duah, F.; Smasal, T. (1993) Metabolism of Triadimefon in Laying
Hens: Lab Project Number: BL040501: 105183. Unpublished study prepared
by Miles Inc. 129 p. 

43125401	Eberhart, D.; Ellisor, G. (1993) Evaluation of Potential
Exposure Resulting from Contact with Bayleton-Treated Turf: Lab Project
Number: 92E043: 105137. Unpublished study prepared by Miles, Inc. 432 p.

43256201	Bowers, L. (1994) Acute Toxicity of Bayleton Technical to the
Rainbow Trout (Oncorhynchus mykiss) Under Static Renewal Conditions: Lab
Project Number: BL812201: 106573. Unpublished study prepared by Miles
Inc. 27 p. 

43284401	Burger, R. (1994) Triadimefon (50DF): Magnitude of the Residue
in Processed Grape Commodities: Lab Project Number: 105043: BL19GR03:
40712. Unpublished study prepared by Miles Inc. in cooperation with ABC
Laboratories, Inc. and The National Food Laboratory, Inc. 648 p. 

43304301	Bowers, L.; Frank, J. (1994) Acute Toxicity of BAYLETON
Technical to the Bluegill (Lepomis macrochirus) under Static-Renewal
Conditions: Lab Project Number: BL810301: 106758. Unpublished study
prepared by Miles Environmental Research Section. 27 p. 

43418301	Hall, L.; Hartz, A. (1994) The Metabolism of (carbon 14)
Triadimefon in the Lactating Goat: Addendum 1: Additional Data as
Requested by the EPA: Lab Project Number: BL041001: 105161-1.
Unpublished study prepared by Miles, Inc. 12 p. 

43418302	Duah, F.; Myers, T. (1994) Metabolism of Triadimefon in Laying
Hens: Addendum 1: Additional Data as Requested by EPA: Lab Project
Number: BL040501: 105183-1. Unpublished study prepared by Miles, Inc. 17
p. 

43418303	Duah, F.; Myers, T.; Freeseman, P. (1994) Extraction Efficiency
of the Analytical Method for Triadimefon Residues in Meat, Milk, and
Eggs: Lab Project Numbers: BL200201: 106449. Unpublished study prepared
by Miles, Inc. 44 p. 

43462401	Duah, F. (1994) Storage Stability of Triadimefon Residues in
Animal Tissues, Milk, and Eggs: Lab Project Number: BL130201: 106638.
Unpublished study prepared by Miles Inc. 37 p. 

43495509	Beyrouty, P. (1992) An Acute Study of the Potential Effects of
Orally Administered Triadimefon on Behavior in Rats: Lab Project Number:
97132. Unpublished study prepared by Bio- Research Lab. Ltd. 276 p. 

43705401	Fomenko, J. (1995) Evaluation of KWG 1732 (a Tridimefon
Metabolite) Through the FDA Multiresidue Methods: Lab Project Numbers:
K2162301: 106963: A012.009. Unpublished study prepared by Huntingdon
Analytical Services. 97 p. 

43870101	Bajzik, M. (1995) Independent Laboratory Validation of the
Analytical Residue Method for Triadimefon and Metabolites in Plant
Matrices (Report No. 106549): Lab Project Number: A012.014: BL111601:
107141. Unpublished study prepared by Huntingdon Analytical Services.
121 p. 

43936101	Dreist, M.; Popp, A. (1996) MEB 6447 (Common Name:
Triadimefon): Acute Oral Neurotoxicity Screening Study in Wistar Rats:
Lab Project Number: 24636: 1058215: 107154. Unpublished study prepared
by Bayer AG. 468 p. 

43948601	Murphy, J. (1996) Triadimefon (50DF)--Magnitude of the Residue
on Processed Apple Commodities: Addendum 1: Additional Information
Requested by EPA: Lab Project Number: BL19AP02: 102636-1: 39591.
Unpublished study prepared by Bayer Corp. 8 p. 

44038901	Lenz, C. (1996) Triadimefon and Metabolites--Freezer Storage
Stability Study in Raw Agricultural Commodities and Processed
Commodities: Addendum 2: Lab Project Number: BL131601: 102641-2: 39683.
Unpublished study prepared by ABC Laboratories, Inc. 586 p. 

44041001	Chopade, H. (1996) Metabolism of (Phenyl-UL-(carbon 14))
Triadimefon in Wheat: Addendum 1--Storage Stability of (carbon 14) KWG
1732 in Wheat Grain: Lab Project Number: BL221601: 105162-1. Unpublished
study prepared by Bayer Corp. 30 p. 

44041002	Chopade, H. (1996) Extraction Efficiency of the Analytical
Residue Method for the Determination of Triadimefon and Metabolite
Residues in Plant Matrices: Determination of Aged (carbon 14)
Triadimefon Residues in Wheat Grain: Lab Project Number: BL221601:
107343. Unpublished study prepared by Bayer Corp. 35 p. 

44153501	Dreist, M.; Popp, A. (1996) MEB 6447 (Common Name:
Triadimefon): Subchronic Neurotoxicity Screening Study in Wistar Rats:
(Thirteen-Week Administration in the Diet with a Four-Week Recovery
Period in Males and a Ten-Week Recovery Period in Females): Lab Project
Number: 25315: T 6058265: 107477. Unpublished study prepared by Bayer
AG. 786 p. 

44166001	Fontaine, L. (1996) Product Chemistry of Bayleton Technical:
Lab Project Number: 107296: 107241: 99642. Unpublished study prepared by
Bayer Corp. 173 p. 

44519801

	Shen, S. (1998) Determination of Residues of Baytan 30 in Processed
Field Corn Fractions: Lab Project Number: 96-003: 963HI: 43514.
Unpublished study prepared by ABC Labs., Inc. and Gustafson Research and
Development Center. 458 p. {OPPTS 860.1520} 

44519802	Shen, S. (1998) Determination of Residues of Baytan 30 in
Processed Cotton Fractions: Lab Project Number: 96-001: 963HG: 43516.
Unpublished study prepared by ABC Labs., Inc. and Gustafson Research and
Development Center. 452 p. {OPPTS 860.1520} 

44519803	Shen, S. (1998) Determination of Residues of Baytan 30 in
Processed Wheat Fractions: Lab Project Number: 96-002: 963HH: 43513.
Unpublished study prepared by ABC Labs., Inc. and Gustafson Research and
Development Center. 462 p. {OPPTS 860.1520} 

44740901	Schaldt, L. (1998) KWG 0519 Oncogenicity Study in CD-1 Mice
(Dietary Administration over 18 Months): Lab Project Number: 28299:
T4060738: 108689. Unpublished study prepared by Bayer AG. 1854 p. 

45654503	Findlay, M.; Chester, G. (1995) Seed Treated Products: Worker
Exposure During Sowing of Treated Seed with "Baytan": Lab Project
Number: N(DEGREES)WER002. Unpublished study prepared by ZENECA
Agrochemicals. 107 p. 

46576207	Mithcell, H. (2005) Product Chemistry of Bayleton FLO
Fungicide. Project Number: BR/2392, ANR/06605, 3414519/1. Unpublished
study prepared by Bayer Corp. 134 p.

46578707	Mitchell, H. (2005) Product Chemistry of Tartan Flo Fungicide.
Project Number: BR/2390, ANR/04605, ANR/04705. Unpublished study
prepared by Bayer Corp. 205 p.

46836301	Mitchell, H. (2006) Product Chemistry of Bayleton 3.62% SC
Systemic Fungicide. Project Number: BR/2462, 201435, ANR/03006.
Unpublished study prepared by Bayer Corp. 180 p.

92188018	Eigenberg, D. (1990) Mobay Corporation Phase 3 Summary of MRID
00149336. A Teratological Evaluation of Bayleton (Triadimefon) in Mated
Female Rats: Project 7272-B (Mobay Report 82270). Prepared by MIDWEST
RESEARCH INSTITUTE. 22 p. 

92188019	Eigenberg, D. (1990) Mobay Corporation Phase 3 Summary of MRID
00155075 and Related MRIDs 00032541. MEB 6447 (Triadimefon)
Multigeneration Reproduction Study on Rats; (Triadimefon) Two-generation
Study with Rats (Bayleton): Projects 8297 and 12712 (Mobay Reports 67752
and 82270). Prepared by BAYER AG. 38 p. 

92188020	Loser, E. (1990) Mobay Corporation Phase 3 Reformat of MRID
00032541 and Related MRIDs 00155075. MEB 6447 (Triadimefon)
Multigeneration Reproduction Study on Rats: Project Number 67752; Report
No. 8297. Prepared by BAYER AG. 173 p. 

92188025	Chopade, H. (1990) Mobay Corporation Phase 3 Summary of MRID
00025540. The Metabolism of BAYLETON in Apples: Project Report No.
53621. Prepared by MOBAY CORPORATION. 14 p. 

92188026	Mango, R.; Puhl, R.; Thornton, J. (1990) Mobay Corporation
Phase 3 Reformat of MRID 00025540. The Metabolism of BAYLETON in Apples:
Project No. 53621. Prepared by MOBAY CORPORATION. 26 p. 

92188027	Chopade, H. (1990) Mobay Corporation Phase 3 Summary of MRID
00031440 and Related MRIDs 00031441. Fate of BAYLETON-Carbon-14 as a 25%
Wettable Powder on Tomatoes and Cucumbers: Project Report Nos. 68593 and
68594. Prepared by MOBAY CORPORATION. 13 p. 

92188028	Nye, D. (1990) Mobay Corporation Phase 3 Reformat of MRID
00031440. Fate of BAYLETON-Carbon-14 as a 25 Percent Wettable Powder on
Tomatoes and Cucumbers: Project Report 68593. Prepared by STONER
LABORATORIES, INC. 33 p. 

92188029	Puhl, R. (1990) Mobay Corporation Phase 3 Reformat of MRID
00031441. Further Identification of Polar Activity from BAYLETON
Cucumber and Tomato Metabolism Samples: Project Report No. 68594.
Prepared by MOBAY CORPORATION. 10 p. 

92188030	Chopade, H. (1990) Mobay Corporation Phase 3 Summary of MRID
00098115. Metabolism of BAYLETON in Wheat: Project Report No. 80293.
Prepared by MOBAY CORPORATION. 14 p. 

92188031	Morgan, J.; Lenz, M. (1990) Mobay Corporation Phase 3 Reformat
of MRID 00098115. Metabolism of BAYLETON in Wheat: Project Report No.
80293. Prepared by MOBAY CORPORATION. 29 p. 

92188032	Chopade, H. (1990) Mobay Corporation Phase 3 Summary of MRID
00150893. Metabolism of BAYLETON on Grapes: Project Report No. 88790.
Prepared by MOBAY CORPORATION. 12 p. 

92188033	Fredrickson, R. (1990) Mobay Corporation Phase 3 Reformat of
MRID 00150893. Metabolism of BAYLETON on Grapes: Project Report No.
88790. Prepared by MOBAY CORPORATION. 21 p. 

92188034	Chopade, H. (1990) Mobay Corporation Phase 3 Summary of MRID
00025543. Metabolism of BAYLETON in the Cow: Project Report No. 66202.
Prepared by MOBAY CORPORATION. 11 p. 

92188035	Fredrickson, D. (1990) Mobay Corporation Phase 3 Reformat of
MRID 00025543. Metabolism of BAYLETON in the Cow: Project Report No.
66202. Prepared by MOBAY CORPORATION. 19 p. 

92188036	Premkumar, N. (1990) Mobay Corporation Phase 3 Summary of MRID
00033058. Metabolism of BAYLETON in Male and Female Pigs: Project No.
66509. Prepared by MOBAY CORPORATION. 16 p. 

92188037	Pither, K. (1990) Mobay Corporation Phase 3 Reformat of MRID
00033058. Metabolism of BAYLETON in Male and Female Pigs: Project Report
No. 66509. Prepared by MOBAY CORPORATION. 25 p. 

92188038	Mathew, A. (1990) Mobay Corporation Phase 3 Summary of MRID
00033070. The Fate of BAYLETON-Carbon-14 in Poultry: Project Report No.
67482. Prepared by MOBAY CORPORATION. 16 p. 

92188039	Nye, D. (1990) Mobay Corporation Phase 3 Reformat of MRID
00033070. The Fate of BAYLETON-Carbon-14 in Poultry: Project Report No.
67482. Prepared by STONER LABORATORIES, INC. 67 p. 

92188040	Obrist, J.; Nichols, S.; Leimkuehler, W. (1990) Mobay
Corporation Phase 3 Reformat of MRID 00025546. An Interference Study for
the BAYLETON and KWG 0519 Residue Method for Crops: Project Report No.
68006. Prepared by MOBAY CORPORATION. 208 p. 

92188041	Leimkuehler, W. (1990) Mobay Corporation Phase 3 Reformat of
MRID 00125782. An Interference Study for BAYLETON Residue Method for
Crops - Resolution of Interference for KWG 1342 and KWG 1323: Project
Report No. 80567. Prepared by MOBAY CORPORATION. 225 p. 

92188042	Chopade, H. (1990) Mobay Corporation Phase 3 Summary of MRID
00149163 and Related MRIDs 00025546, 00125782. Residue Analysis
Procedure for BAYLETON and Metabolites in Plants: Project Report Nos.
80488, 68006 and 80567. Prepared by MOBAY CORPORATION. 16 p. 

92188043	Obrist, J.; Leimkuehler, W. (1990) Mobay Corporation Phase 3
Reformat of MRID 00149163. Residue Analysis Procedure for BAYLETON and
Metabolites in Barley and Wheat: Project Report No. 80488. Prepared by
MOBAY CORPORATION. 28 p. 

92188044	Minor, R. (1990) Mobay Corporation Phase 3 Summary of MRID
00090019 and Related MRIDs 00090020, 00063837, 00072538, 00149342,
00063835. Analytical Methods for BAYLETON in Various Animal Tissues:
Project Report Nos. 69531, 80265, 68705, 68798, 69028 and 68887.
Prepared by ANALYTICAL DEVELOPMENT CORP. 21 p. 

92188045	Kruplak, J. (1990) Mobay Corporation Phase 3 Reformat of MRID
00090019. BAYLETON Total Residue Method Verification (Bovine): Project
Report No. 69531. Prepared by ANALYTICAL DEVELOPMENT CORP. 158 p. 

92188046	Obrist, J.; Nichols, S. (1990) Mobay Corporation Phase 3
Reformat of MRID 00063835. An Interference Study for the BAYLETON and
KWG 0519 Residue Method for Bovine Tissues and Milk: Project report No.
68887. Prepared by MOBAY CORPORATION. 67 p. 

92188047	Kruplak, J.; Weissenburger, B.; Bache (1990) Mobay Corporation
Phase 3 Reformat of MRID 00063837. Determination of BAYLETON and KWG
0519 in Cattle Tissues: Project Report No. 68705. Prepared by ANALYTICAL
DEVELOPMENT CORP. 31 p. 

92188048	Kruplak, J.; Bache, B.; Breault, G. (1990) Mobay Corporation
Phase 3 Reformat of MRID 00072538. Residue Analysis Procedure for the
Determination of BAYLETON and KWG 0519 in Bovine Milk: Project Report
No. 68798. Prepared by ANALYTICAL DEVELOPMENT CORP. 19 p. 

92188051	Premkumar, N. (1990) Mobay Corporation Phase 3 Summary of MRID
00025541 and Related MRIDs 00098117, 41027902. Storage Stability of
BAYLETON, BAYTAN, KWG 1323 and KWG 1342 in Apple Peel, Potatoes, Grapes
and Wheat Green Forage; and Storage Stability of KWG 1323 and KWG 1342
in Wheat Grain: Project Report Nos. 54192, 80338 and 98432. Prepared by
MOBAY CORPORATION. 11 p. 

92188052	Thornton, J. (1990) Mobay Corporation Phase 3 Reformat of MRID
00025541. The Stability of BAYLETON and KWG 0519 Residues in Apple Peel
During Frozen Storage: Project Report No. 54192. Prepared by MOBAY
CORPORATION. 8 p. 

92188053	Fredrickson, D. (1990) Mobay Corporation Phase 3 Reformat of
MRID 00098117. The Stability of BAYLETON and BAYTAN Residues in Wheat
Forage During Storage: Project Report No. 80338. Prepared by MOBAY
CORPORATION. 7 p. 

92188054	Bornatsch, W. (1990) Mobay Corporation Phase 3 Summary of MRID
00090021. Effect of Feeding BAYLETON and the Metabolite KWG 0519
(BAYTAN) to Dairy Cattle -- Total Residue: Project Report No. 69930.
Prepared by MOBAY CORPORATION. 9 p. 

92188055	Kruplak, J. (1990) Mobay Corporation Phase 3 Reformat of MRID
00090021. Effect of Feeding BAYLETON and the Metabolite KWG 0519
(BAYTAN) to Dairy Cattle -- Total Residues: Project Report No. 69930.
Prepared by ANALYTICAL DEVELOPMENT CORP. 247 p. 

92188056	Mathew, A. (1990) Mobay Corporation Phase 3 Summary of MRID
00090022. Effect of Feeding BAYLETON and the Metabolite KWG 0519
(BAYTAN) to Poultry - Total Residue: Project No. 80281. Prepared by
MOBAY CORPORATION. 12 p. 

92188057	Kruplak, J.; Weissenburger, B. (1990) Mobay Corporation Phase 3
Reformat of MRID 00090022. Effect of Feeding BAYLETON and the Metabolite
KWG 0519 (BAYTAN) to Poultry - Total Residues: Project Report No. 80281.
Prepared by ANALYTICAL DEVELOPMENT CORP. 174 p. 

92188060	Leslie, W. (1990) Mobay Corporation Phase 3 Summary of MRID
00067381 and Related MRIDs 00109463. Triadimefon (BAYLETON 25WP
Formulation) - Magnitude of the Residues on Chick Peas: Project Report
Nos. 68905, 68906, 68907, 68908, 68909, 80723, 80930 and 80931; Mobay
Report No. 100117-1. Prepared by MOBAY CORPORATION. 13 p. 

92188061	Biehn, W. (1990) Mobay Corporation Phase 3 Summary of MRID
00143953 and Related MRIDs 00153279. Triadimefon: Magnitude of the
Residue on Raspberries: IR-4 No. 2552. Prepared by ICI Americas Inc. 20
p. 

92188062	Leslie, W. (1990) Mobay Corporation Phase 3 Summary of MRID
00072532 and Related MRIDs 00149342. Triadimefon (BAYLETON 50WP
Formulation) - Magnitude of the Residues on Seed Grass: Project Report
Nos. 80670, 80673, 80674, 80675 and 80676; Mobay Report No. 100114-1.
Prepared by MOBAY CORPORATION. 12 p. 

92188063	Leslie, W. (1990) Mobay Corporation Phase 3 Summary of MRID
00128337. Triadimefon (BAYLETON 50WP Formulation) Magnitude of the
Residues on Sugar Beets: Project Report Nos. 81198, 81199, 82800, 82801,
82802, 82803, 82804, 82805, 82806, 82807, 82808, 82809, 82811, 82814,
82815, 82816, 82817 and 82818; Mobay Report 100115-1. Prepared by MOBAY
CORPORATION. 17 p. 

92188064	Leslie, W. (1990) Mobay Corporation Phase 3 Summary of MRID
00098114 and Related MRIDs 00149329, 00061736. Magnitude of the Residues
on Wheat: Objective No. (3012): Report Nos. 80494, 80495, 80530, 80542,
80545, 80546, 80547, 80550, 80551, 80552, 80553, 82821, 82874, 84208,
82822 and 82824; Mobay Report No. 100111-1. Prepared by MOBAY
CORPORATION. 14 p. 

92188065	Leslie, W. (1990) Mobay Corporation Phase 3 Summary of MRID
00128337. Triadimefon (BAYLETON 50WP Formulation) - Magnitude of the
Residue in Unprocessed Sugar Beets and Sugar Beet Processed Products:
Project Report Nos. 84211, 84212 and 82811; Mobay Report No. 100116-1.
Prepared by MOBAY CORPORATION. 12 p. 

92188069	Leslie, W. (1990) Mobay Corporation Phase 3 Reformat of MRID
00128337. Triadimefon (BAYLETON 50WP Formulation) - Magnitude of the
residues in Unprocessed Sugar Beets and Sugar Beet processed Products:
Project Nos. (82811, 84211, 84212); Mobay Report No. 100116. Prepared by
MOBAY CORPORATION. 56 p. 

92188070	Leslie, W. (1990) Mobay Corporation Phase 3 Reformat of MRID
00067381 and Related MRIDs 00109463. Triadimefon (BAYLETON 25WP
Formulation) - Magnitude of the Residues on Chick Peas (Project Nos.
68905, 68906, 68907, 68908, 68909, 80723, 80930, 80931); Mobay Report
No. 100117. Prepared by MOBAY CORPORATION. 55 p. 

92188073	Leslie, W. (1990) Mobay Corporation Phase 3 Reformat of MRID
00128337. Triadimefon (BALETON 50WP) - Magnitude of the Residues on
Sugar Beets: (Project Nos. 81198, 81199, 82205, 82206, 82207, 82800,
82801, 82802, 82812, 82813, 82814, 82815, 82816, 82817, 82818); Mobay
Report No. 10115. Prepared by MOBAY CORPORATION. 204 p. 

92188074	Leslie, W. (1990) Mobay Corporation Phase 3 Reformat of MRID
00098114 and Related MRIDs 00149329, 00061736. Triadimefon (BAYLETON
50WP Formulation) - Magnitude of the Residues on Wheat: (Report Nos.
80494, 80495, 80530, 80542, 80545, 80546, 80547, 80550, 80551, 80552,
80553, 82821, 82874, 84208, 82822, 82824); Mobay Report No. 100111.
Prepared by MOBAY CORPORATION. 219 p. 

92188075	Leslie, W. (1990) Mobay Corporation Phase 3 Reformat of MRID
00072532 and Related MRIDs 00149342. Triadimefon (BAYLETON 50WP
Formulation) - Magnitude of the Residues on Seed Grass: Project Report
Nos. (80670, 80673, 80674, 80675, 80676, 82848, 82854, 82855, 82856,
82857, 82858); Mobay Report 100114. Prepared by MOBAY CORPORATION. 121
p. 

92188320	Bayer Ag Institute of Toxicology; Two Generation Study with
Rats; Report No.: 12712, Report Author: Dr. R. Eiben (Also under MRIDs
00155075, 92188019 and TRID Number 470102-011).

None

None

None

None

None

None

None

None

None

None

None

None

None

None	  SEQ CHAPTER \h \r 1 Allen, J., Wolf, D., George, M. Hester, S.,
Sun G., Thai, S-F., Delker, D., Nelson, G., Winkfield, E. Roop, B.,
Leavitt, S., Ward, W., and Nesnow, S. (2005) Comparable Liver P450
Enzyme Activity and Histopathology in Mice Treated With the Conazole
Fungicides: Myclobutanil, Propiconazole and Triadimefon. The
Toxicologist. Abstract. No, 2146.

	Crofton, KM. 1996. A structure- activity relationship for the
neurotoxicity of triazole fungicites.  Toxicol. Lett 84 (3): 155-159.

	Crofton, KM., Boneck, VM., and Reiter, LW. 1988.  Hyperactivity induced
by triaedimefon, a triazole fungicide.  Fundam. Appl. Toxicol.  10,
459-465.

	Crofton, KM., Boneck, VM., and MacPhail, RC. 1989.  Evidence for
monoaminergic involvement in triadimefon- induced hyperactivity,
Psychopharmacology 97, 326-330.

	Crofton, KM., Howard, JL., Moser, VC., Gill, MW., et al. 1991. 
Interlaboratory comparison of motor activity experiments: implications
for neurotoxicological assessments.  Neurotoxicol. Teratol. 13 (6): 599-
609.

	Crofton, KM., Makris, SL., Sette, WF., Mendez, E., and Raffaele, KC.
2004.  A qualitative retrospective analysis of positive control data in
developmental neurotoxicity studies.  Neurotoxicology and Teratology 26;
345-352.352.

	Goetz, A.K., Blystone, C., Ren, H., Schmid, J.E., Nichols, H.P., Bao,
W., Best, D.S., Narotsky, M.G., Wolf, D.C., Rockett, J.C., and Dix, D.J.
(2005) Reproductive Effects of Exposure to Conazole Fungicides in the
Male Rat. The Toxicologist. Abstract No 2148.

	Golub, M., Costa, L., Crofton, K., Frank, D., Fried, P., Gladen, B.,
Henderson, R., Liebelt, E., Lusskin, S., Marty, S., Rowland, A.,
Scialli, J., and Vore, M. 2005.  NTP-CERHR expert panel report on the
reproductive and developmental toxicity of methylphenidate.  Birth
Defects Research (part B) 74:300-381.

	Hester, S., Thai, S.-F., Wolf, D., Ward, W., and Nesnow, S. (2005)
Comparison of Gene Expression Profiles from Rats Fed Acute Levels of
Three Toxicologically Different Conazoles. The Toxicologist. Abstract
No. 2149.

	Ikaiddi, MU., Akunne, HC., and Soliman, KE. 1997. Behavioral and
neurochemical effects of acute and repeated administration of
triadimefon in the male rat.  Neurotoxicology 18(3): 771-80.

	Moser, VC and MacPhail, RC. 1989.  Neurobehavioral effects of
triadimefon, a triazole fungicide, in male and female rats.
Neurotoxicol. Teratol. 11, 285-293.

	Moser, VC and MacPhail, RC. 1992. International validation of the
neurobehavioral screening battery: The IPCS/WHO collaborative study.
Toxicol. Lett. 64-65 Spec. No., 217-223. 

	Moser, VC., Cheek, BM., and MacPhail, RC.  1995. A multidisciplinary
approach to toxicological screenings: III. Neurobehavioral toxicity. 
Journal Toxicol Environ Health Jun 45(2): 173-210.

	Ren, H., Schmid, J.E., Retief, J., Turpaz, Y., Zhang, X., Jones, P.D.,
Newsted, J.L., Giesy, J.P., Wolf, D.C., Wood, C.R., Bao, W., and Dix,
D.J. (2005) Profiling Gene Expression in Human H295R Adrenocortical
Carcinoma Cells and Rat Testes to Identify Pathways of Toxicity for
Conazole Fungicides. The Toxicologist. Abstract No. 2150.

None

None

None

None	Sun G, Thai SF, Tully DB, Lambert GR, Goetz AK, Wolf DC, Dix DJ,
Nesnow S:  Propiconazole-induced cytochrome P450 gene expression and
enzymatic activities in rat and mouse liver. Tox Lett 155: 277-287,
2004; and abstracts from the 2005 SOT meeting,

	Walker, QD and Mailman, RB. 1996.  Triadimefon and triadimenol: effects
on monoamine uptake and release.  Toxicol. Appl. Pharmacol. 139 (2):
227- 233.

	Ward, W., Delker, D., Hester, S., Thai, S-F., Allen, J., Jones, C.,
Wolf, D., and Nesnow, S. (2005) Comparison of Hepatic Gene Expression
Profiles from Mice Exposed to Three Toxicologically Different Conazoles.
The Toxicologist. Abstract No. 2147.

	Wolf, D.C., Allen, J., Sun, G., Thibodeaux, J., George, M., Hester,
S.D., Thai, S.-F., Delker, D., Nelson, G., Winkfield, E., Roop, B.,
Leavitt, S., Ward, W., and Nesnow, S. (2005) Triadimefon Induces Rat
Thyroid Tumors Through a Non-TSH Mediated Mode of Action. The
Toxicologist. Abstract No. 2144.

Appendix E.  Generic Data Call-In 

Appendix E.

The generic data call-in will be posted at a later date.

Appendix F.  Product Specific Data Call-In

Appendix F.

The product specific data call-in will be posted at a later date.  SEQ
CHAPTER \h \r 1 Appendix G: Batching of Triadimenol/Triadimefon Products

EPA'S BATCHING OF TRIADIMENOL/TRIADIMEFON PRODUCTS FOR MEETING ACUTE
TOXICITY DATA REQUIREMENTS FOR REREGISTRATION

In an effort to reduce the time, resources and number of animals needed
to fulfill the acute toxicity data requirements for reregistration of
products containing TRIADIMENOL or TRIADIMEFON as the active ingredient,
the Agency has batched products which can be considered similar for
purposes of acute toxicity. Factors considered in the sorting process
include each product's active and inert ingredients (identity, percent
composition and biological activity), type of formulation (e.g.,
emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and
labeling (e.g., signal word, use classification, precautionary labeling,
etc.).  Note that the Agency is not describing batched products as
"substantially similar" since some products within a batch may not be
considered chemically similar or have identical use patterns.

Using available information, batching has been accomplished by the
process described in the preceding paragraph. Notwithstanding the
batching process, the Agency reserves the right to require, at any time,
acute toxicity data for an individual product should the need arise. 

Registrants of products within a batch may choose to cooperatively
generate, submit or cite a single battery of six acute toxicological
studies to represent all the products within that batch. It is the
registrants' option to participate in the process with all other
registrants, only some of the other registrants, or only their own
products within a batch, or to generate all the required acute
toxicological studies for each of their own products.  If a registrant
chooses to generate the data for a batch, he/she must use one of the
products within the batch as the test material.  If a registrant chooses
to rely upon previously submitted acute toxicity data, he/she may do so
provided that the data base is complete and valid by today's standards
(see acceptance criteria attached), the formulation tested is considered
by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute
toxicity data. Regardless of whether new data is generated or existing
data is referenced, registrants must clearly identify the test material
by EPA Registration Number. If more than one confidential statement of
formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.

In deciding how to meet the product specific data requirements,
registrants must follow the directions given in the Data Call-In Notice
and its attachments appended to the RED. The DCI Notice contains two
response forms which are to be completed and submitted to the Agency
within 90 days of receipt.  The first form, "Data Call-In Response,"
asks whether the registrant will meet the data requirements for each
product.  The second form, "Requirements Status and Registrant's
Response," lists the product specific data required for each product,
including the standard six acute toxicity tests.  A registrant who
wishes to participate in a batch must decide whether he/she will provide
the data or depend on someone else to do so.  If a registrant supplies
the data to support a batch of products, he/she must select one of the
following options: Developing Data (Option 1), Submitting an Existing
Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an
Existing Study (Option 6). If a registrant depends on another's data,
he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share
(Option 3) or Citing an Existing Study (Option 6). If a registrant does
not want to participate in a batch, the choices are Options 1,  4, 5 or
6. However, a registrant should know that choosing not to participate in
a batch does not preclude other registrants in the batch from citing
his/her studies and offering to cost share (Option 3) those studies.

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

	

Batching Instructions for Triadimenol:

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

NOTE: The technical acute toxicity values included in this document are
for informational purposes only.  The data supporting these values may
or may not meet the current acceptance criteria.

No Batch	EPA Reg. No.	Percent Active Ingredient

	264-742	25.00

	264-743	98.30

	264-760	28.30

	264-939	Triademinol:  5.00

Tetramethylthiuram disulfide:  15.30

	264-941	30.00

	264-980	Triademinol:  13.33

Azoxystrobin:  8.00

Metalaxyl:  40.00

	2935-459	30.00

Fifty one products were found which contain Triadimefon as the active
ingredient.  These products have been placed in seven batches and a no
batch group in accordance with the active and inert ingredients and type
of formulation. 

Batching Instructions for Triadimefon:

Batch 3A:  Products in this Batch may cite studies conducted on products
in Batch 3.

Batch 6:  Each product in this Batch must conduct a primary eye
irritation study using the fertilizer with the highest percentage of
nitrogen. 

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

NOTE: The technical acute toxicity values included in this document are
for informational purposes only.  The data supporting these values may
or may not meet the current acceptance criteria.

Batch 1	EPA Reg. No.	Percent Active Ingredient

	264-737	50.0

	264-740	50.0

	432-1294	50.0

	432-1360	50.0

	432-1367	50.0

Batch 2	EPA Reg. No.	Percent Active Ingredient

	432-1293	25.0

	432-1309	25.0

	432-1316	25.0

	432-1317	25.0

Batch 3	EPA Reg. No.	Percent Active Ingredient

	4-342	1.0

	432-1295	1.0

	432-1336	1.0

	961-354	1.0

	8378-55	1.0

	9198-111	1.0

	10404-58	1.0

	28293-278	1.0

	32802-41	1.0

	34704-802	1.0

Batch 3A	EPA Reg. No.	Percent Active Ingredient

	4-362	0.50

	432-1296	0.50

	869-224	0.50

	829-288	0.50

	961-353	0.50

	7401-432	0.50

	8378-54	0.50

	8660-199	0.78

	9198-112	0.50

	9198-187	0.59

	28293-280	0.50

	32802-42	0.50

	72155-47	0.50

Batch 4	EPA Reg. No.	Percent Active Ingredient

	432-1297	0.88

	829-289	0.88

	72155-48	0.88

Batch 5	EPA Reg. No.	Percent Active Ingredient

	869-222	0.88

	2724-691	0.88

Batch 6	EPA Reg. No.	Percent Active Ingredient

	961-388	0.10

	961-389	0.05

	9198-190	0.62

	10404-65	0.50

No Batch 	EPA Reg. No.	Percent Active Ingredient

	264-736	97.70

	264-757	Triadimefon:  2.10

Sulfur:  53.70

	432-1300	22.00

	432-1412	Triadimefon:  8.33

Trifloxystrobin:  41.67

	432-1445	43.00

	432-1446	Triadimefon:  20.86

Trifloxystrobin:  4.17

	9198-169	Triadimefon:  16.00

Metalaxyl:  16.00

	9198-197	Triadimefon:  1.59

Thiram:  40.76

	64014-3	0.88

	72155-46	1.00

H.	List of Registrants Sent this Data Call-In

United States Environmental Protection Agency

Washington, D.C.  20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name:	2700, Triadimefon

Co. Number	Company Name	Agent for	Address	City and State	Zip

264 	

BAYER CROPSCIECNCE

2 T.W. Alexander Drive	

Research Triangle Park	

NC 27709

			

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

				

		  SEQ CHAPTER \h \r 1 Pesticide Registration Forms are available at
the following EPA internet site:

		http://www.epa.gov/opprd001/forms/.

Pesticide Registration Forms (These forms are in PDF format and require
the Acrobat reader) 

Instructions

	1.	Print out and complete the forms. (Note: Form numbers that are
bolded can be filled out on your computer then printed.)

	2.	The completed form(s) should be submitted in hardcopy in accord with
the existing policy. 

      	3.	Mail the forms, along with any additional documents necessary
to comply with EPA regulations covering your request, to the address
below for the Document Processing Desk.

DO NOT fax or e-mail any form containing 'Confidential Business
Information' or 'Sensitive Information.'

If you have any problems accessing these forms, please contact Nicole
Williams at (703) 308-5551 or by e-mail at
williams.nicole@epamail.epa.gov.

The following Agency Pesticide Registration Forms are currently
available via the internet:

at the following locations:

8570-1	Application for Pesticide Registration/Amendment
http://www.epa.gov/opprd001/forms/8570-1.pdf.

8570-4	Confidential Statement of Formula
http://www.epa.gov/opprd001/forms/8570-4.pdf.

8570-5	Notice of Supplemental Registration of Distribution of a
Registered Pesticide Product 
http://www.epa.gov/opprd001/forms/8570-5.pdf.

8570-17	Application for an Experimental Use Permit
http://www.epa.gov/opprd001/forms/8570-17.pdf.

8570-25	Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need 
http://www.epa.gov/opprd001/forms/8570-25.pdf.

8570-27	Formulator's Exemption Statement
http://www.epa.gov/opprd001/forms/8570-27.pdf.

8570-28	Certification of Compliance with Data Gap Procedures 
http://www.epa.gov/opprd001/forms/8570-28.pdf.

8570-30	Pesticide Registration Maintenance Fee Filing 
http://www.epa.gov/opprd001/forms/8570-30.pdf.

8570-32	Certification of Attempt to Enter into an Agreement with other
Registrants for Development of Data 
http://www.epa.gov/opprd001/forms/8570-32.pdf.

8570-34	Certification with Respect to Citations of Data  (in PR Notice
98-5)	http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf.

8570-35	Data Matrix  (in PR Notice 98-5)
http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf.

8570-36	Summary of the Physical/Chemical Properties  (in PR Notice 98-1)
http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf.

8570-37	Self-Certification Statement for the Physical/Chemical
Properties  (in PR Notice 98-1)
http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf.

Pesticide Registration Kit		www.epa.gov/pesticides/registrationkit/.

Dear Registrant:

	For your convenience, we have assembled an online registration kit
which contains the following pertinent forms and information needed to
register a pesticide product with the U.S. Environmental Protection
Agency's Office of Pesticide Programs (OPP):

	1.	The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and
the Federal Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food
Quality Protection Act (FQPA) of 1996. 

 

	2.	Pesticide Registration (PR) Notices 

		a.	83-3 Label Improvement Program--Storage and Disposal Statements

 

		b.	84-1 Clarification of Label Improvement Program

 

		c.	86-5 Standard Format for Data Submitted under FIFRA

 

		d.	87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)

 

		e.	87-6 Inert Ingredients in Pesticide Products Policy Statement

 

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

 

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

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

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

	3.	Pesticide Product Registration Application Forms (These forms are in
PDF format and will require the Acrobat reader.)  

	

		a.	EPA Form No. 8570-1, Application for Pesticide
Registration/Amendment 

		b.	EPA Form No. 8570-4, Confidential Statement of Formula 

		c.	EPA Form No. 8570-27, Formulator's Exemption Statement 

		d.	EPA Form No. 8570-34, Certification with Respect to Citations of
Data

 

		e.	EPA Form No. 8570-35, Data Matrix 

	4.	General Pesticide Information (Some of these forms are in PDF format
and will require the Acrobat reader.) 

		a.	Registration Division Personnel Contact List

	b.	Biopesticides and Pollution Prevention Division (BPPD) Contacts

		c.	Antimicrobials Division Organizational Structure/Contact List 

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

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

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

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

Before submitting your application for registration, you may wish to
consult some additional sources of information.   These include: 

	1.	The Office of Pesticide Programs' Web Site 

	2.	The booklet "General Information on Applying for Registration of
Pesticides in the United States", PB92-221811, available through the
National Technical Information Service (NTIS) at the following address: 

			National Technical Information Service (NTIS)

			5285 Port Royal Road

			Springfield, VA 22161 

The telephone number for NTIS is (703) 605-6000. 

	3.	The National Pesticide Information Retrieval System (NPIRS) of
Purdue University's Center for Environmental and Regulatory Information
Systems. This service does charge a fee for subscriptions and custom
searches. You can contact NPIRS by telephone at (765) 494-6614 or
through their Web site. 

4.	The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of
pesticides. You can contact NPTN by telephone at (800) 858-7378 or
through their Web site: ace.orst.edu/info/nptn.

The Agency will return a notice of receipt of an application for
registration or amended registration, experimental use permit, or
amendment to a petition if the applicant or petitioner encloses with his
submission a stamped, self-addressed postcard. The postcard must contain
the following entries to be completed by OPP: 

Date of receipt;

EPA identifying number; and

Product Manager assignment.

		Other identifying information may be included by the applicant to link
the acknowledgment of receipt to the specific application submitted. EPA
will stamp the date of receipt and provide the EPA identifying File
Symbol or petition number for the new submission. The identifying number
should be used whenever you contact the Agency concerning an application
for registration, experimental use permit, or tolerance petition.

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搒Ý␱㜀$␸䠀$摧㠍ÙԀassist us in ensuring that all data you
have submitted for the chemical are properly coded and assigned to your
company, please include a list of all synonyms, common and trade names,
company experimental codes, and other names which identify the chemical
(including "blind" codes used when a sample was submitted for testing by
commercial or academic facilities). Please provide a chemical abstract
system (CAS) number if one has been assigned.

Documents Associated with this RED 

				

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

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

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

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

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