United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508P)
EPA 738R-06-027
July 2006
Reregistration
Eligibility Decision
(RED) for
Propiconazole
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REREGISTRATION ELIGIBILITY
DECISION
for
Propiconazole
Case No. 3125
List C
Approved by:
/S/
Debra Edwards, Ph.D.
Director, Special Review and
Reregistration Division
July 18,2006
Date
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TABLE OF CONTENTS
Propiconazole Reregistration Eligibility Decision Team i
Glossary of Terms and Abbreviations ii
ABSTRACT 1
I. Introduction 1
IE. Chemical Overview 2
A. Regulatory History 2
B. Chemical Identification 3
1. Propiconazole 3
2. Free Triazole Metabolites 4
C. Use Profile 5
D. Estimated Usage of Propiconazole 6
Dl Summary of Propiconazole Risk Assessments 7
A. Human Health Risk Assessment 8
1. Toxicity of Propiconazole and the Free Triazoles 9
2. Carcinogenicity 16
3. Endocrine Effects 17
4. Factors Considered in EPA's Aggregate Assessment 17
5. Aggregate Risk Assessment for Propiconazole and Free Triazoles 21
6. Occupational Exposure and Risk 26
B. Environmental Fate and Effects Risk Assessment 38
1. Environmental Fate and Transport 39
2. Ecological Exposure and Risk 39
3. Endangered Species 52
4. Ecological Incidents 53
IV. Risk Management, Reregistration, and Tolerance Reassessment 54
A. Determination of Reregistration Eligibility 54
B. Public Comments and Responses 54
C. Regulatory Position 55
1. Food Quality Protection Act Findings 55
2. Endocrine Disruptor Effects 56
3. Cumulative Risks 57
D. Tolerance Reassessment Summary 57
1. T olerance Definition 57
2. Tolerance Reassessment Summary 58
3. Codex Harmonization 64
4. Residue Analytical Method 65
E. Regulatory Rationale 65
1. Human Health Risk Management 66
2. Non-Target Organism (Ecological) Risk Management 69
3. Summary of Mitigation Measures 73
F. Other Labeling Requirements 74
1. Endangered Species Considerations 74
2. Spray Drift Management 75
A. Manufacturing Use Products 76
1. Generic Data Requirements 76
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2. Labeling for Manufacturing Use Products 77
B. End-Use Products 78
1. Additional Product-Specific Data Requirements 78
2. Labeling for End-Use Products 78
C. Labeling Changes Summary Table 78
D. Existing Stocks 78
VI. APPENDICES 87
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Propiconazole Reregistration Eligibility Decision Team
Office of Pesticide Programs
Biological and Economic Analysis Assessment
Jenna Carter
Tara Chan-Goyal
Environmental Fate and Effects Risk Assessment
Ed Odenkirchen
Bill Evans
James Lin
Thuy Nguyen
Health Effects Risk Assessment
Mike Doherty
Yan Donovan
Monica Hawkins
David Hrdy
Abdallah Khasawinah
James Scott Miller
Antimicrobial Team Support
Tim Leighton
Cassi Walls
Stacey Grigsby
Diane Isbell
Registration Support
Robert Tomerlin
Tamue Gibson
Mary Waller
Risk Management
Christina Scheltema
Kimberly Nesci
Kevin Costello
Office of General Counsel
Erin Koch
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Glossary of Terms and Abbreviations
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-in
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disruptor Screening Program
EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause
death in 50% of test animals, usually expressed as the weight of substance per weight or volume of
water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals
when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOC Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
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N/A
Not Applicable
NASS
National Agricultural Statistical Service
NAWQA
USGS National Water Quality Assessment
NMFS
National Marine Fisheries Service
NOAEC
No Observed Adverse Effect Concentration
NOAEL
No Observed Adverse Effect Level
NPIC
National Pesticide Information Center
OPP
EPA Office of Pesticide Programs
ORETF
Outdoor Residential Exposure Task Force
PAD
Population Adjusted Dose
PCA
Percent Crop Area
PDCI
Product Specific Data Call-In
PDP
USDA Pesticide Data Program
PHED
Pesticide Handler's Exposure Data
PHI
Preharvest Interval
ppb
Parts Per Billion
PPE
Personal Protective Equipment
PRZM
Pesticide Root Zone Model
RBC
Red Blood Cell
RED
Reregistration Eligibility Decision
REI
Restricted Entry Interval
RfD
Reference Dose
RPA
Reasonable and Prudent Alternatives
RPM
Reasonable and Prudent Measures
RQ
Risk Quotient
RTU
(Ready-to-use)
RUP
Restricted Use Pesticide
SCI-GROW
Tier I Ground Water Computer Model
SF
Safety Factor
SL
Single layer clothing
SLN
Special Local Need (Registrations Under Section 24(c) of FIFRA)
STORET
Storage and Retrieval
TEP
Typical End-Use Product
TGAI
Technical Grade Active Ingredient
TRAC
Tolerance Reassessment Advisory Committee
TTRs
Transferable Turf Residues
UF
Uncertainty Factor
USDA
United States Department of Agriculture
USFWS
United States Fish and Wildlife Service
USGS
United States Geological Survey
WPS
Worker Protection Standard
Ill
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ABSTRACT
The Environmental Protection Agency (EPA or the Agency) has completed the human health
and environmental risk assessments for propiconazole and is issuing its risk management 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 registered products and
additional information received through the public docket. After considering the risks identified in the
revised risk assessments, comments received, and mitigation suggestions from interested parties, the
Agency developed its risk management decision for uses of propiconazole that pose risks of concern.
As a result of this review, EPA has determined that propiconazole-containing products are eligible for
reregistration, provided that risk mitigation measures are adopted and labels are amended accordingly.
That decision is discussed fully in this document.
I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (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 U.S. Environmental Protection
Agency (referred to as EPA or "the Agency"). 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 hazards 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 (FQPA) was signed into law. This Act
amends FIFRA and the Federal Food, Drug, and Cosmetic Act (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 of 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.
As mentioned above, FQPA requires EPA to 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 chemicals causing a common toxic effect by a common
mechanism could lead to the same adverse health effect as would a higher level of exposure to any
one of these individual chemicals. Propiconazole belongs to a group of pesticides called triazoles (or
conazoles), which also includes the triazole fungicides subject to reregistration, triadimefon and
triadimenol. For the purpose of this reregistration eligibility decision (RED), EPA has concluded that
propiconazole does not share a common mechanism of toxicity with other substances. However, the
triazole fungicides share common metabolites, the free triazole compounds 1,2,4-triazole, triazole
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alanine, and triazole acetic acid, which are considered in this RED. 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 (OPP) concerning common mechanism determinations and procedures for evaluating
cumulative effects from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative/.
Propiconazole also shares 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 is working 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
exposures from one or both sources of 1,2,4-triazole residues.
This document presents EPA's revised human health and ecological risk assessments, its
progress toward tolerance reassessment, and the reregistration eligibility decision for propiconazole.
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
chemical; Section III gives an overview of the human health and environmental effects risk
assessments; Section IV presents the Agency's decision on reregistration eligibility and risk
management; and Section V summarizes the label changes necessary to implement the risk mitigation
measures outlined in Section IV. Finally, the Appendices list related information, supporting
documents, and studies evaluated for the reregistration decision. The revised risk assessments for
propiconazole are available in the OPP docket and in the Agency's electronic docket on the internet at
http://www.regulations.gov under docket number EPA-HQ-OPP-2005-0497.
IE. Chemical Overview
A. Regulatory History
Propiconazole was first registered in 1981 by Ciba Geigy for use on grass grown for seed.
The Agency approved additional uses on sugarcane, pecan, cereal grains, rice, and bananas (import
only) in 1987 and tolerances were established for these commodities. Additional food uses on celery,
stone fruit, and wild rice were approved by EPA in 1993, and uses on corn, pineapple and peanuts
were approved in 1994. Novartis became the technical registrant for propiconazole in 1996, after the
merger of Ciba Geigy and Sandoz. Syngenta, one of the current technical registrants, acquired
propiconazole in 2000 as the result of a merger of Novartis and Zeneca.
Today, propiconazole is registered for use on numerous food and feed crops; 55 permanent
and 15 temporary tolerances have been established. Propiconazole is also registered for use on turf
and ornamentals and for use as a wood preservative. The Agency has approved FIFRA Section 24c
Special Local Need registrations for propiconazole on mint, sunflower grown for seed, nonbearing
blueberries, sugarcane seed pieces, wheat, corn, bananas, and nonbearing hazelnuts. EPA has also
approved FIFRA Section 18 Emergency Exemptions for propiconazole on dry bean, sorghum,
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blueberries, cranberries, and raspberries. Although the registrant has submitted petitions to the
Agency for additional food uses, these have not been considered as part of this reregistration eligibility
decision (RED) and will be addressed by the Agency at a later time as a separate decision.
Propiconazole is also registered for use as an antimicrobial pesticide by Janssen
Pharmaceutica; the first antimicrobial product was registered in 1996. Today propiconazole is used in
material preservation and wood preservation products. As a materials preservative, propiconazole is
used in items such as metalworking fluids, adhesives, caulks, coatings, stains, paints, inks, paper,
textiles, canvas, cordage, leather, and leather finishing pastes, fat liquors, or finishes. The two major
registrants, Syngenta and Janssen, have requested amendments to their propiconazole registrations
deleting use for treatment of carpet fibers, apparel, and furnishings1. The primary textile use includes
"canvas" (i.e., awnings, boat covers, carpet backing, cordage, tents, tarpaulins, and wall coverings).
As a wood preservative, the products can be used on green or fresh cut lumber, poles, posts, and
timbers; manufactured wood products such as logs (such as those used in the construction of log
homes), wood chips/sawdust, plywood veneer, and particle board; dry lumber; and finished wood
products such as millwork, shingles, shakes, siding, plywood, and structural lumber and composites.
The majority of the products are intended for use at wood treatment facilities; however, propiconazole
is also formulated for use in mushroom houses, to protect timber trays and benches, and for use on
wood in cooling towers.
Because propiconazole is on List C of Reregistration Priorities, EPA did not complete a
Registration Standard. However, two Data Call-Ins (DCIs) were issued for propiconazole on
September 30, 1993 and January 4, 1994. Generic data requirements necessary to complete
reregistration included environmental fate and effects studies, product and residue chemistry studies,
and avian, fish, invertebrate, and mammalian toxicity studies. Propiconazole was also included in the
Agricultural Re-entry DCI issued on October 6, 1995 for worker dermal and inhalation exposure
monitoring and foliar residue dissipation studies.
B. Chemical Identification
1. Propiconazole
Chemical Structure:
Common Name: Propiconazole
Chemical Name: 1 -((2-(2,4-Dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl)methyl)- 1H-1,2,4-
1 EPA published a Notice of this request in the Federal Register on March 8,2006 (71FR11622) and issued an order
amending propiconazole registrations on May 26, 2006.
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triazole
Trade Name:
Chemical Family:
Tilt, Alamo®, Banner®, Orbit®, and Quilt™
Triazole, Conazole
Case Number:
CAS Number:
PC Code:
3125
60207-90-1
122101
342.23
Molecular Weight:
Empirical Formula:
Basic Manufacturer:
C15H17CI2N3O2
Janssen Pharmaceutica, Inc.; Syngenta Crop Protection
Other Technical Registrants: Dow AgroSciences; Irvita Plant Protection; Makteshim-Agan
2. Free Triazole Metabolites
Propiconazole and other triazole fungicides are metabolized in animals and plants to form
compounds containing the triazole moiety (free triazole metabolites), including 1,2,4-triazole, triazole
alanine, and triazole acetic acid, which are also considered in this decision. Because triazole alanine
and triazole acetic acid are formed by conjugation with an amino acid, they are referred to as triazole
conjugates throughout this document. Chemical information for these triazole metabolites is provided
below.
Chemical Name: 1,2,4-Triazole
Common Names: 1,2,4-T; free triazole
CAS Number: 288-88-0
PC Code: 600074
Molecular weight: 69.07
a. 1,2,4-Triazole
b. Triazole Alanine
Chemical Name: Triazole Alanine (TA)
CAS No. 86362-20-1
PC Code: 600011
Molecular weight: 156.15
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c. Triazole Acetic Acid
Chemical Name: Triazole Acetic Acid (TAA)
CAS No. 28711-29-7
PC Code: 600082
Molecular weight: 127.10
C. Use Profile
The following is information on the currently registered uses of propiconazole, including an
overview of use sites and application methods. A detailed table of the uses of propiconazole eligible
for reregistration is available in Appendix A.
Type of Pesticide: Fungicide, Antimicrobial
Target Pest: Bacteria, fungi, viruses (plant pathogens and spoilage agents)
Mode of Action: Inhibits an enzyme involved in ergosterol biosynthesis, which is
critical to the formation of the cell walls in fungi, thereby slowing or
stopping fungal growth.
Use Sites: Propiconazole is used on a number of agricultural crops, fruit and nut
trees, ornamentals, and turf. Propiconzole is also used as a wood
preservative and as an antimicrobial/material preservative in
adhesives, paints, coatings, leather, paper; textiles, and specialty
industrial products.
Terrestrial Food
and Feed Uses: Banana; Barley; Celery; Dry beans and peas; Field corn, Sweet corn,
and Popcorn; Filbert; Pecan; Plantain; Stone fruits; Sunflower; Wheat;
Barley; Cereal grains; Citrus; Kumquat; Lemon; Lime; Mint; Oats;
Orange; Peanuts, Pineapple (seed piece treatment); Rice and Wild rice;
Rye; Sugarcane; Tangerine; Tree nuts; Triticale; Wheat
Terrestrial NonFood Uses: Turf, including golf courses and sod farms; Ornamentals; Nonbearing
citrus, fruit, and nut trees
Antimicrobial Uses: Adhesives, Coatings, Paints, Wood preservative
Use Classification: General Use
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Emulsifiable concentrate, Flowable concentrate, Liquid ready-to-use,
Liquid soluble concentrate, Wettable powder, Dust
Band treatment; Chemigation; Dip treatment; Directed spray; Ground
spray; Hides and skins treatment; High volume spray (dilute);
Industrial preservative treatment; Injection treatment; Low volume
spray (concentrate); Soak; Spray; Tree injection treatment; Wood
protection treatment by pressure; Wood surface treatment
Propiconazole application rates vary by use. For most agricultural
uses, propiconazole is applied at less than 1 pound active ingredient
per acre (lb ai/A) for crops, but it may be applied at up to 1.8 lb ai/A
for turf and ornamentals. Antimicrobial end-use products contain
propiconazole at concentrations ranging from 0.1 to 50% ai.
Maximum concentrations for various antimicrobial uses are 0.65% ai
solution for an open dip tank, 0.8% ai solution for conventional spray,
and 50%) ai solution for electrostatic spray.
At bud break; At emergence; At pegging; Bloom; Boot; Crown;
Delayed dormant; Dormant; Early bloom; Early fall; Early spring;
Early summer; Fall; Foliar; Internode elongation; Late fall; Late
spring; Late winter; May; Nonbearing; Nonbearing nurserystock; Not
on label; Nurserystock; Petal fall; Petal fall through foliar; Pink;
Popcorn; Postplant; Prebloom; Precutting; Preharvest; Preplant; Seed
piece; Seedling stage; Shock/slug; Spring; Summer; Tillering; When
needed; Winter
D. Estimated Usage of Propiconazole
A screening-level estimate of the usage of propiconazole indicates that approximately 345,000
pounds of propiconazole active ingredient (ai) were used annually from 1999 to 2004. A five year
average was calculated using EPA source data and data from the US Department of Agriculture's
(USDA) National Agricultural Statistics Service (NASS) for the years 2000 to 2004. These data are
presented in Table 1 below.
Tabic 1. National Agricultural Usage of Propiconazole - Highest Use Sites
Crop
Average Annual
Amount Used
(lbs. a.i.)
Average Annual
Total Area Treated
(A)
Average Annual
Percent Crop
T rcatcd
Almonds
830
8,000
>5
Apples
33
300
>1
Apricots
840
8,100
29
Barley
11,000
150,000
3
Celery
2,500
23,000
49
Cherries
3,900
36,000
18
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Formulation Types:
Application Methods:
Application Rates:
Application Timing:
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Tabic 1. National Agricultural Usajjc of Propiconazole - Highest Use Sites
Crop
Average Annual
Amount Used
(lbs. a.i.)
Average Annual
Total Area Treated
(A)
Average Annual
Percent Crop
T rcatcd
Dry Beans/Peas
560
5,300
51
Filberts
1,500
8,500
19
Peaches
12,000
110,000
31
Peanuts
48,000
810,000
73
Pecans
38,000
410,000
18
Prunes
4,400
40,000
18
Rice
58,000
420,000
55
Sweet Corn
15,000
140,000
11
Wheat, Spring
57,000
780,000
56
Wheat, Winter
91,000
940,000
62
EPA Source Data and USDA NASS (2000-2004)
DI. Summary of Propiconazole Risk Assessments
The following is a summary of EPA's human health and ecological effects risk assessments
for propiconazole, as presented fully in the following documents:
• Propiconazole: Phase 4, HED Chapter of the Re-registration Eligibility Decision
Document (RED). June 28, 2006
• Revised Drinking Water Assessment of Propiconazole. June 7, 2006
• Propiconazole: Revised Occupational and Residential Exposure Assessment of the
Antimicrobial Uses to Support the Reregistration Eligibility Decision (RED) Document.
February 1, 2006.
• Propiconazole: Amendment to the Propiconazole Reregistration Eligibility Decision
(RED) Document for Children's Postapplication Exposure Treated Structures.
June 20, 2006
• Environmental Fate and Effects Division Revised RED for the Reregistration of
Propiconazole. June 30, 2006
Risks for 1,2,4-triazole, triazole alanine, and triazole acetic acid are considered in this RED
because they are common metabolites of propiconazole and other triazole fungicides. The purpose if
this summary is to assist the reader by identifying the key features and findings of these risk
assessments, and to help the reader better understand the conclusions reached in the assessments.
The human health and ecological risk assessment documents and supporting information
listed in Appendix C were used to reach the safety finding and regulatory decision for propiconazole.
Although the risk assessments and related addenda are not included in this document, they are
available from the OPP Public Docket OPP-2005-0497 and may also be accessed on the website
www.regulations. gov. Hard copies of these documents may be found in the OPP public docket under
this same docket number.
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A. Human Health Risk Assessment
EPA released its preliminary risk assessments for propiconazole, 1,2,4-triazole, triazole
alanine, and triazole acetic acid for public comment on February 15, 2006 for a 60-day public
comment period (Phase 3 of the public participation process). The preliminary risk assessments may
be found in the OPP public docket at the address given above and on the website
www.regulations.gov. In response to comments received and new studies submitted during Phase 3,
the risk assessments were updated and refined. The human health risk assessment for propiconazole
was revised on June 28, 2006, to incorporate comments and additional studies submitted by the
registrant. In addition, the Agency is considering late comments on the 1,2,4-triazole risk assessment
which may allow EPA to refine the risk assessments for the free triazoles. However, because these
risk assessment refinements are not expected to alter the conclusions of the propiconazole RED, they
are not incorporated into this decision document. The Agency's use of human studies in the
propiconazole risk assessment is in accordance with the Agency's Final Rule promulgated on January
26, 2006, related to Protections for Subjects in Human Research, which is codified in 40 CFR Part 26.
Revised risk assessments for propiconazole may be found in the OPP dockets under docket
number OPP-2005-0497. Major revisions to the risk assessment include the following:
• Revision of estimated drinking water concentrations (EDWCs) used in the dietary risk
assessment;
• Incorporation of new drinking estimates, new food residue estimates for rice and
processed commodities, and the revised FQPA safety factor into the dietary risk
assessment; and
• Consideration of post-application residential risk associated with use of propiconazole
as a wood preservative on dimensional lumber.
The human health risk assessment incorporates potential exposure from all sources, which
include food, drinking water, residential (if applicable), and occupational 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. The Agency's human
health assessment is protective of all U.S. populations, including infants and young children.
This document summarizes risk estimates for both propiconazole and its free triazole
metabolites 1,2,4-triazole, triazole alanline, and triazole acetic acid. Propiconazole and the other
triazole fungicides metabolize to these 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 aggregate or combined risks from food, drinking water and non-occupational exposure
resulting from propiconazole alone and from the free triazoles from all sources. In addition, EPA has
also considered potential co-exposure to free triazoles resulting from pharmaceutical uses of triazole
compounds. The aggregate risk from all sources of the free triazoles must be considered to reassess
the tolerances for propiconazole in accordance with FQPA. Because the risks associated with the free
triazoles are all below the Agency's level of concern, they are not addressed in as much detail as the
risks from propiconazole. Additional details regarding the risks associated with the free triazoles may
be found in the February 3, 2006 document, 1,2,4-Triazole, Triazole Alanine, Triazole Acetic Acid:
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Human Health Aggregate Risk Assessment in Support ofReregistration and Registration Actions for
Triazole Derivative Fungicide Compounds, which is available in the public docket (EPA-HQ-OPP-
2005-0497).
1. Toxicity of Propiconazole and the Free Triazoles
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 effects, or reproductive effects), and the level or dose at
which such effects might occur. The Agency has reviewed all toxicity studies submitted for
propiconazole and has determined that the toxicological database is complete, reliable, and sufficient
for reregistration. For more details on the toxicity of propiconazole, see the January 27, 2006
document, Propiconazole - Hazard Characterization Assessment for the Reregistration Eligibility
Decision, which is available under docket number EPA-HQ-OPP-2005-0497.
As previously mentioned, 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 propiconazole. 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
and TRIAZOLES - 2nd Report of the Ad Hoc HED Peer Review Committee, which is available under
docket number EPA-HQ-OPP-2005-0497.
a. Acute Toxicity Profile for Propiconazole
Propiconazole is classified as category III for acute oral and dermal toxicity and as category
IV for acute inhalation toxicity. It is classified as category III for eye irritation potential and category
IV for skin irritation potential. Propiconazole caused dermal sensitization in guinea pigs. The acute
toxicity profile for technical grade propiconazole is summarized in Table 2 below. These data are
presented only to provide background information on the active ingredient and may not be appropriate
for product reregistration. Additional acute toxicity data may be required to determine appropriate
cautionary label language for products containing propiconazole. Acute toxicity data are not
presented for the free triazoles because they do not occur in pesticide products, and thus are not
considered in product labeling.
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Tabic 2. Acute Toxicity Profile for Propiconazole
Guideline
Study Type
MRID
Results
Toxicity
Category
870.1100
Acute Oral - Rat
00058591
LD50= 1517 mg/kg
III
870.1200
Acute Dermal - Rabbit
0058596
LD50 > 4000 mg/kg
III
870.1300
Acute Inhalation
41594801
LC50> 5.84 mg/L
IV
870.2400
Primary Eye Irritation
00058598
Corneal Opacity reversed in 72 hours
III
870.2500
Primary Skin Irritation
00058598
Non- irritant
IV
870.2600
Dermal Sensitization
44949501
Sensitizer
N/A
LD50 or LC50 - Median Lethal Dose or Concentration, statistically derived single dose or concentration that can be expected to
cause death in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation). N/A - not
applicable.
b. FQPA Safety Factor Considerations
The Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act (FQPA), directs the Agency to use an additional ten fold (10X) safety factor (SF) to
account for potential pre- and postnatal toxicity and completeness of the data with respect to exposure
and toxicity to infants and children. FQPA authorizes the Agency to modify the 10X FQPA SF only
if reliable data demonstrate that the resulting level of exposure would be safe for infants and children.
Propiconazole
The Agency has reviewed the toxicology database for propiconazole and concluded that it is
adequate to characterize any potential for prenatal or postnatal risk for infants and children. The
requirement for a developmental neurotoxicity study in propiconazole was waived because no effects
were seen in a submitted acute neurotoxicity study. In light of the existing toxicology database for
propiconazole, EPA concluded that there is low concern for pre- and/or postnatal toxicity resulting
from exposure to propiconazole and that there are no residual uncertainties. Because there was no
evidence of increased susceptibility, the FQPA SF for propiconazole per se was reduced to IX. This
SF also considers the completeness of the exposure database for food, drinking water, and residential
exposure. The FQPA SF reflects the Agency's confidence that the risk assessment for each potential
exposure scenario includes all metabolites and degradates of concern and will not result in an
underestimate of dietary or residential risks to infants and children.
Free Triazoles
1,2,4-Triazole. EPA has reviewed the available toxicology studies for 1,2,4-triazole and
determined that the database is sufficient to conduct an FQPA assessment and adequate to characterize
prenatal and postnatal effects. From the existing toxicity data, the Agency has concluded that there
are low residual concerns and no residual uncertainties with regard to pre- and/or postnatal toxicity of
10
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1,2,4-triazole. However, EPA has retained a 10X FQPA SF based on nervous system effects and
database uncertainties, including data gaps for the acute and developmental neurotoxicity studies. (A
developmental neurotoxicity study is required for 1,2,4-triazole.) The Agency believes that the
exposure estimates for 1,2,4-triazole will not result in an underestimation of either dietary or
residential risks to infants and children.
Triazole Conjugates (Triazole Alanine and Triazole Acetic Acid). For the triazole conjugates,
triazole alanine and triazole acetic acid, the toxicology database is incomplete to characterize
increased potential increased susceptibility to pre- and postnatal effects. However, the available rat
developmental toxicity and two-generation reproduction studies for these conjugates showed
increased qualitative and quantitative susceptibility of the offspring. Therefore, the 10X FQPA SF is
retained for increased susceptibility and database uncertainties (data gaps for rabbit developmental
toxicity studies with triazole alanine and triazole acetic acid, a chronic rat study with triazole alanine,
and a combined 90-day/subchronic neurotoxicity rat study for triazole acetic acid). Although
increased qualitative and quantitative susceptibility of the offspring was seen in the developmental
toxicity and two-generation reproduction studies in rats, the currently selected dietary, residential, and
occupational endpoints are all based on no observed adverse effects levels (NOAELs) that are
protective of these adverse effects. Additionally, no evidence of neurotoxicity was seen in the
available toxicology database, so a developmental neurotoxicity study is not being required at this
time. The Agency believes that the exposure estimates for the triazole conjugates will not result in an
underestimation of either dietary or residential risks to infants and children.
c. Toxicological Endpoints
Propiconazole. The toxicological endpoints used in the human health risk assessment for
propiconazole are listed in Table 3 below, as well as the estimated dermal and inhalation absorption
factors used in the risk assessment. The Agency estimated that 40% of an applied dose of
propiconazole is absorbed through the skin, based on a rat dermal absorption study. For inhalation
exposure, EPA used a default factor of 100% absorption. The uncertainty factors (UF) and safety
factors used to account for interspecies extrapolation, intraspecies variability, and special susceptibility
of infants and children (FQPA SF) are also described in Table 3.
Tabic 3. Toxicological Doses and Endpoints for Propiconazole for Use in Human Health Risk Assessments
Exposure
Scenario
Dose, Uncertainty Factors
(UF)
FQPA Safety Factor
(SF) and Level of
Concern
Study and Toxicological
Endpoint for Risk Assessment
Acute Dietary
(Females age 13-50)
NOAEL = 30 mg/kg/day
UF =100
Acute RfD =0.3 mg/kg/day
FQPA SF = 1
aPAD= acute RfD
FQPA SF
= 0.3 mg/kg/day
Developmental Toxicity Study -
Rats. Increased incidence of
rudimentary ribs, cleft palate
malformations (0.3%) unossified
sternebrae, as well as increased
incidence of shortened and absent
renal papillae at LOAEL of 90
mg/kg/day.
11
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Tabic 3. Toxicoloiiical Doses and Endpoints for Propiconazolc for Use in Human Health Risk Assessments
Exposure
Scenario
Dose, Uncertainty Factors
(UF)
FQPA Safety Factor
(SF) and Level of
Concern
Study and Toxicologic:!!
Endpoint for Risk Assessment
Acute Dietary
(General Population
including infants and
children)
NOAEL = 30 mg/kg/day
UF =100
Acute RfD = 0.3 mg/kg/day
FQPA SF = 1
aPAD = acute RfD
FQPA SF
= 0.3 mg/kg/day
Acute Neurotoxicity Study - Rats.
Clinical toxicity: piloerection,
diarrhea, tip toe gait at LOAEL of
100 mg/kg/day.
Chronic Dietary
(All populations)
NOAEL = 10 mg/kg/day
UF= 100
Chronic RfD = 0.1 mg/kg/day
FQPA SF = 1
cPAD = chronic RfD
FQPA SF
= 0.1 mg/kg/day
24 Month Oncogenicity Study -
Mice.
Liver toxicity; increased liver
weight in males, and increase in
liver lesions (masses/raised areas/
swellings/nodular areas). LOAEL
is 50 mg/kg/day.
Short-Term
Incidental Oral
(1-30 days)
NOAEL= 30 mg/kg/day
UF= 100
FQPA SF = 1
Residential LOC for
MOE is 100.
Acute Neurotoxicity Study - Rats.
Clinical toxicity: piloerection,
diarrhea, tip toe gait at LOAEL is
100 mg/kg/day.
Intermediate-T erm
Incidental Oral
(1-6 months)
NOAEL= 10 mg/kg/day
UF= 100
FQPA SF = 1
Residential LOC for
MOE is 100.
24 Month Oncogenicity Study -
Mice.
Liver toxicity; increased liver
weight in males, and increase in
liver lesions (masses/raised areas/
swellings/nodular areas)).
LOAEL is 50 mg/kg/day.
Short-Term Dermal
(1 - 30 days)
(general population
including infants and
children)
Oral NOAEL= 30 mg/kg/day
UF= 100
(Dermal absorption rate = 40%)
FQPA SF = 1
Residential LOC for
MOE is 100.
Occupational LOC for
MOE is 100.
Acute Neurotoxicity Study - Rats.
Clinical toxicity: piloerection,
diarrhea, tip toe gait at LOAEL of
100 mg/kg/day.
Intermediate- (1-6
months) and Long-
Term Dermal
(>6 months)
Oral NOAEL= 10 mg/kg/day
UF= 100
(Dermal absorption rate = 40%)
FQPA SF = 1
Residential LOC for
MOE is 100.
Occupational LOC for
MOE is 100.
24 Month Oncogenicity Study -
Mice.
Liver toxicity; ncreased liver
weight in males and increase in
liver lesions (masses/raised areas/
swellings/nodular areas).
12
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Tabic 3. Toxicological Doses and Endpoints for Propiconazolc for Use in Human Health Risk Assessments
Exposure
Scenario
Dose, Uncertainty Factors
(UF)
FQPA Safety Factor
(SF) and Level of
Concern
Study and Toxicological
Endpoint for Risk Assessment
Short-Term Inhalation
(1 - 30 days)
Oral NOAEL= 30 mg/kg/day
UF= 100
(Inhalation absorption rate =
100%)
FQPA SF = 1
Residential LOC for
MOE is 100.
Occupational LOC for
MOE is 100.
Acute Neurotoxicity Study - Rats.
Clinical toxicity: piloerection,
diarrhea, tip toe gait at LOAEL of
100 mg/kg/day. LOAEL is 50
mg/kg/day.
Intermediate-Term (1
- 6 months) and Long-
Term Inhalation
(>6 months)
Oral NOAEL= 10 mg/kg/day
UF= 100
(Inhalation absorption rate =
100%)
FQPA SF = 1
Residential LOC for
MOE is 100;
Occupational LOC for
MOE is 100.
24 Month Oncogenicity Study -
Mice.
Liver toxicity (increased liver
weight in males and increase in
liver lesions (masses/raised areas/
swellings/nodular areas)).
LOAEL is 50 mg/kg/day.
Cancer
(Oral, dermal,
inhalation)
Classified as a Group C, possible human carcinogen, RfD used for risk characterization because
the chronic RfD is protective of any potential carcinogenic effects.
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.
Free Triazoles. The toxicological endpoints used in the assessment for the free triazoles are
presented in the February 7, 2006 document, 1,2,4-Triazole, Triazole Alanine, Triazole Acetic Acid:
Human Health Aggregate Risk Assessment in Support ofReregistration and Registration Actions for
Triazole-derivative Fungicide Compounds, which is available in docket EPA-HQ-OPP-2005-0497.
The toxicological endpoints used in the human health risk assessments for 1,2,4-triazole and the
conjugates triazole alanine and triazole acetic acid are summarized in Tables 4 and 5, respectively.
Because the available data on the conjugates are limited, the Agency has assumed that all conjugates
(i.e., triazole alanine and trizole acetic acid) are toxicologically equivalent. For both dermal and
inhalation exposure, EPA assumed that 100% of applied dose is absorbed.
13
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Tabic 4. Toxicological Doses and Endpoints for 1,2,4-Tria/olc for Use in Human Health Risk Assessments
Exposure
Scenario
Dose, Uncertainty Factors
(UF) '
FQPA Safety Factor (SF)
and Level of Concern
Study and Toxicologic:!!
Endpoint for Risk Assessment
Acute Dietary
(females age 13-49)
NOAEL = 30 mg/kg/day
UF=100
Acute RfD = 0.3 mg/kg/day
FQPA SF = 10
aPAD = acute RfD
FQPA SF
= 0.03 mg/kg/day
Developmental Toxicity study -
rabbits.
LOAEL is 45 mg/kg based on
urinary tract malformations in
fetuses
Acute Dietary
(general population
including infants and
children)
NOAEL = 30 mg/kg
UF=100
Acute RfD = 0.3 mg/kg/day
FQPA SF = 10
aPAD = acute RfD
FQPA SF
= 0.03 mg/kg/day
Developmental Toxicity study -
rabbits.
LOAEL is 45 mg/kg based on
clinical signs and mortality in does
starting on Gestation Day 6 or 7
Chronic Dietary
(all populations)
LOAEL =15 mg/kg/day
UF =300
Chronic RfD = 0.05
mg/kg/day
FQPA SF =10
cPAD = chronic RfD
FQPA SF
= 0.005 mg/kg/day
Reproductive Toxicity study -
rats.
LOAEL is 15 mg/kg/day based on
decreased body weight in adult
males, decreased body weight and
brain weight in offspring; no
NOAEL established for this study
(hence additional 3X UF).
Incidental Oral Short-
term
(1-30 days)
NOAEL = 30 mg/kg/day
UF=100
FQPA SF = 10
Residential LOC for MOE
is 1000.
Developmental Toxicity study -
rabbits.
LOAEL is 45 mg/kg/day based on
clinical signs and mortality in does
starting on Gestation Day 6 or 7.
Incidental Oral
Intermediate- or
Long-term
(30 days to 6 months)
LOAEL =15 mg/kg/day
UF = 300
FQPA SF = 10
Residential LOC for MOE
is 3000.
Reproductive Toxicity study -
rats.
LOAEL is 15 mg/kg/day based on
decreased body weight in adult
males, decreased body weight and
brain weight in offspring; no
NOAEL established for this study
(hence additional 3X UF)..
Dermal Short-term (1-
30 days)
NOAEL = 30 mg/kg/day
UF= 100
FQPA SF = 10
Residential LOC for MOE
is 1000.
Developmental Toxicity study -
rabbits.
LOAEL is 45 mg/kg/day based
on clinical signs and mortality in
does starting on Gestation Day 6
or 7.
Dermal
Intermediate- or
Long-term
(30 days to 6 months)
LOAEL =15 mg/kg/day
UF = 300
FQPA SF = 10
Residential LOC for MOE
is 3000.
Reproductive Toxicity study -
rats.
LOAEL is 15 mg/kg/day based on
decreased body weight in adult
males, decreased body weight and
brain weight in offspring; no
NOAEL established for this study
(hence additional 3X UF).
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Tabic 4. Toxicological Doses and Endpoints for 1,2,4-Tria/olc for Use in Human Health Risk Assessments
Exposure
Scenario
Dose, Uncertainty Factors
(UF) '
FQPA Safety Factor (SF)
and Level of Concern
Study and Toxicologic:!!
Endpoint for Risk Assessment
Inhalation
Short-term
(1 - 30 days)
NOAEL = 30 mg/kg/day
UF= 100
FQPA SF = 10
Residential LOC for MOE
is 1000
Developmental Toxicity study -
rabbits.
LOAEL is 45 mg/kg/day based
on
clinical signs and mortality in does
starting on Gestation Day 6 or 7
Inhalation
Intermediate- or
Long-term
(30 days to 6 months)
LOAEL =15 mg/kg/day
UF = 300
FQPA SF = 10
Residential LOC for MOE
is 3000.
Reproductive Toxicity study -
rats.
LOAEL is 15 mg/kg/day based on
decreased body weight in adult
males, decreased body weight and
brain weight in offspring; no
NOAEL established for this study
(hence additional 3X UF).
Cancer (oral, dermal,
inhalation)
Not Classified for potential carcinogenicity. Any potential cancer effects would be covered using
the chronic RfD.
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.
Table 5. Toxicological Doses and Endpoints for the T ri azoic Conjugates for Use in Human Health Risk
Assessments
Exposure
Scenario
Dose, Uncertainty Factors
(UF)
FQPA Safety Factor (SF)
and Level of Concern
Study and Toxicologic:!! Endpoint
for Risk Assessment
Acute Dietary
(females 13-49)
NOAEL = 100 mg/kg/day
UF= 100
Acute RfD = 1 mg/kg/day
FQPA SF = 10
aPAD = acute RfD
FQPA SF
= 0.1 mg/kg/day
Prenatal Developmental Toxicity -
rat
LOAEL is 300 mg/kg/day
based on increased incidence of
skeletal findings (unossified
odontoid process).
Acute Dietary (general
population, including
infants and children)
None
None
No appropriate dose and endpoint
could be identified for these
population groups.
Chronic Dietary
(all populations)
NOAEL = 90 mg/kg/day
UF= 100
Chronic RfD = 0.9 mg/kg/day
FQPA SF = 10
cPAD = chronic RfD
FQPA SF
= 0.09 mg/kg/day
90-Day Oral Toxicity - rat
LOAEL is 370/400 mg/kg/day
(M/F) based on decreased leukocyte
counts in males and decreased
triglycerides in females.
Incidental Oral
(all durations)
NOAEL = 90 mg/kg/day
UF= 100
FQPA SF = 10
Residential LOC for MOE is
1000.
90-Day Oral Toxicity - rat
LOAEL is 370/400 mg/kg/day
(M/F) based on decreased leukocyte
counts in males and decreased
triglycerides in females.
15
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Tabic 5. Toxicoloiiical Doses and Endpoints for the T ri azoic Conjugates for Use in Human Health Risk
Assessments
Exposure
Scenario
Dose, Uncertainty Factors
(UF)
FQPA Safety Factor (SF)
and Level of Concern
Study and Toxicologic:!! Endpoint
for Risk Assessment
Dermal
(all durations)
NOAEL = 90 mg/kg/day
UF= 100
(dermal absorption rate =
100%)
FQPA SF = 10
Residential LOC for MOE is
1000.
Occupational LOC for MOE
is 100.
90-Day Oral Toxicity - rat
LOAEL is 370/400 mg/kg/day
(M/F) based on decreased leukocyte
counts in males and decreased
triglycerides in females.
Inhalation
(all durations)
NOAEL = 90 mg/kg/day
UF= 100
(inhal. absorption rate = 100%)
FQPA SF = 10
Residential LOC for MOE is
1000.
Occupational LOC for MOE
is 100.
90-Day Oral Toxicity - rat
LOAEL is 370/400 mg/kg/day
(M/F) based on decreased leukocyte
counts in males and decreased
triglycerides in females.
Cancer (oral, dermal,
inhalation)
Not Classified for potential carcinogenicity. Any potential cancer effects would be covered using
the chronic RfD.
UF, uncertainty factor; FQPA SF, FQPA safety factor; NOAEL, no observed adverse effect level; LOAEL, lowest
observed adverse effect level; RfD, reference dose; PAD, population adjusted dose (a = acute, c = chronic); MOE, margin
of exposure; LOC, level of concern; NA, Not Applicable.
2. Carcinogenicity
Propiconazole. The Agency classified propiconazole as a Group C, possible human
carcinogen, based on increased hepatocellular adenomas, combined adenomas/carcinomas, and
hepatocellular carcinomas in male mice in a chronic oral feeding study. However, animals in the high
dose group for this study showed excessive toxicity; furthermore, the high dose exceeded the
Maximum Tolerated Dose determined in the 90-day range finding study. No treatment-related tumors
were seen in female mice in this mouse chronic feeding study. No tumors were noted in a chronic rat
study. Therefore, the Reference Dose (RID) approach is considered to be protective of any
carcinogenic effects and is recommended for use in cancer risk assessment for propiconazole. This
approach is also consistent with results of voluntary nonguideline mechanism of action studies
conducted by the propiconazole technical registrant.
Mode of Action for Triazole Compounds. Research by the U.S. Triazole Task Force and by
EPA's National Health and Environmental Effects Research Laboratory (NHEERL) indicates that the
hepatic tumors associated with parent triazole compounds occur as a result in changes in liver
metabolism rather than by a genetic response to the compound. The triazole compounds do not
appear to be carcinogenic by a genotoxic mode of action, but rather by a threshold mechanism.
Therefore, a Reference Dose (RfD) approach is considered appropriate for evaluating the hepatic
cancer risk associated with these compounds.
Free Triazoles. No chronic toxicity or cancer studies are available for 1,2,4-triazole, triazole
alanine, or tirazole acetic acid. However, 1,2,4-triazole and triazole alanine are not mutagenic.
Because a chronic cancer study is not available, the Agency used an RfD approach to assess cancer
risks, using the most sensitive toxicity endpoint and an additional 10X uncertainty factor to account
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for the absence of chronic toxicity studies. The Agency believes that this approach and the current
chronic dietary exposure assessment are sufficiently protective of any cancer-related effects and is
consistent with the approach for propiconazole.
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 ED STAC'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). When additional appropriate screening and/or testing protocols being
considered under the Agency's EDSP have been developed, propiconazole and the free triazole
metabolites may be subjected to further screening and/or testing to better characterize effects related to
endocrine disruption.
Propiconazole. The toxicology database for propiconazole did not show any estrogen,
androgen, or thyroid mediated toxicity.
Free Triazoles. The toxicology database for 1,2,4-triazole showed potential estrogen,
androgen, and/or thyroid mediated toxicity, including testicular changes and sperm abnormalities,
ovarian changes, delays in sexual maturation, and dose-related decreases in thyroid stimulating
hormone. The Agency's risk assessment for 1,2,4-triazole is protective of these effects. However,
none of the available toxicity studies for triazole alanine and triazole acetic acid showed any estrogen,
androgen, or thyroid toxicity.
4. Factors Considered in EPA's Aggregate Assessment
The FQPA amendments to the Federal Food, Drug, and Cosmetic Act (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. Because propiconazole and the other triazole
fungicides, and other compounds may metabolize to the free triazoles in animals and plants, EPA has
considered exposure both to propiconazole and to all sources of the free triazoles in the aggregate risk
assessment. The components and basic assumptions of EPA's exposure and risk assessments for
food, drinking water, and residential exposure to propiconazole and the free triazoles are explained
below.
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a. Dietary Exposure and Risk
Dietary risk assessments consider exposure to pesticide residues from both food and
drinking water. To estimate dietary risks from food and drinking water, EPA compares the
estimated amount of potential exposure to pesticide residues in food and drinking water to the
acute or chronic population adjusted dose, or PAD. The PAD is the dose at which an individual
could be exposed without adverse health effects. The PAD is derived from the reference dose
(RfD), which is adjusted for the FQPA SF. Both acute and chronic dietary risk assessments were
conducted for propiconazole. For risks resulting from exposure in food and drinking water, a
risk estimate that is less than 100% of the acute or chronic PAD (aPAD or cPAD) does not
exceed EPA's level of concern. For propiconazole, the aPAD is 0.3 mg/kg/day for all population
subgroups, and the cPAD is 0.1 mg/kg/day.
Although propiconazole is classified as a group C, possible human carcinogen, the
Agency believes that the chronic dietary risk assessment will be protective of any potential
cancer effects. Therefore an RfD approach was utilized for cancer risk assessment. Acute and
chronic dietary risk assessments were conducted for the general US population and several
population subgroups, including females age 13-49 and infants <1 year old. Additional details
about the dietary risk assessment for propiconazole are described in the August 18, 2005,
document, Propiconazole Acute and Chronic Dietary Exposure Assessment for Reregistration
Eligibility Decision (RED) and in the June 15, 2006 document, Propiconazole Revised Acute and
Chronic Dietary Exposure Assessments for Reregistration Evaluation Decision (RED)- Phase 4.
Food. For propiconazole, EPA assumes that residues are present, at the tolerance level, in all
commodities with existing and proposed tolerances. To evaluate dietary exposure to the free triazoles
in food, EPA considered all commodities with existing tolerances for parent triazole fungicides as of
September 1, 2005. EPA assumed that 100% of the food or feed crops with tolerances for
propiconazole or other triazole fungicides are treated. For a comprehensive list of the parent triazole
fungicides and their existing tolerances, please see 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.
Residue monitoring data for 1,2,4-triazole, triazole alanine, and triazole acetic acid are
available for several commodities; these monitoring data were used to estimate anticipated residues
for 1,2,4-triazole in food. For all other commodities, EPA estimated indirect residues of the free
triazoles by multiplying the tolerance of the parent triazole compound by a metabolic conversion
factor and a molecular weight conversion factor.
Dietary exposure was estimated using food consumption data from USDA's Continuing
Surveys of food Intake by Individuals (CSFH) from 1994 to 1996 and 1998 and the Dietary Exposure
Evaluation Model (DEEM-FCID™). For processed commodities without individual tolerances, EPA
used default processing factors from DEEM.
Drinkins Water. EPA has evaluated potential drinking water exposure to propiconazole
because environmental fate data for propiconazole indicate it is persistent and moderately mobile in
soil, with mobility depending on soil organic content. This evaluation includes a review of the
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existing water monitoring and environmental fate data for propiconazole. To date, EPA has not
established health advisory or maximum contaminant levels (MCLs) for residues of propiconazole in
drinking water.
Because water monitoring data for propiconazole are limited, the Agency used screening-level
models to estimate drinking water concentrations of propiconazole from surface and groundwater. To
estimate propiconazole concentrations in surface water, EPA used the PRZM-EXAMS screening
models, with an adjustment for the percent crop area treated in an index reservoir, for all crops except
rice. The Agency modeled representative scenarios to estimate levels of propiconazole in surface
water from runoff after application to agricultural crops, fruit and nut trees, and turf. To estimate
drinking water concentrations of propiconazole following application to rice, the Agency used a
modification of the conservative rice paddy model, which estimates concentrations of a chemical in
the water column and in the undiluted water released from the rice paddy, accounting for some
pesticide degradation, but does not consider movement of pesticide on suspended sediment. EPA's
rice paddy scenario is based on high clay soils in the Mississippi Valley or Gulf Coast regions. To
estimate propiconazole concentrations in groundwater sources of drinking water, EPA used the Tier I
SCI-GROW model, which is based on the results of several prospective groundwater monitoring
studies. Estimated Drinking Water Concentrations of Propiconazole (EDWCs) are presented in Table
6. Additional details regarding the drinking water exposure assessment for propiconazole may be
found in the June 29, 2005, document, Drinking Water Assessment of Propiconazole and the June 7,
2006 document, Revised Drinking Water Assessment of Propiconazole.
Tabic 6. Estimated Drinking Water Concentrations of Propiconazole
Crop Scenario Region Modeled PCA
Estimated Drinking Water
Concentration (EDWC), ppm
Screening-Level Model
Used in Assessment
Acute
Chronic
Surface Water
Turf
York County PA
0.87
76.46
37.53
PRZM-EXAMS
Osceola County,
FL
65.28
26.54
Rice
Mississippi
Valley
Gulf Coast
N/A
86.4
2.92
2002 Rice Paddy Model
Groundwater
Turf&
Ornamentals
Not applicable
N/A
0.72
0.72
SCI-GROW
Because very limited water monitoring data are available for 1,2,4-triazole, triazole alanine,
and triazole acetic acid, the Agency used screening-level models to estimate drinking water
concentrations of the triazole metabolites in surface and groundwater. As for propiconazole, EPA
used the PRZM-EXAMS and SCI-GROW screening-level models to derive EDWCs for surface and
groundwater, respectively. These values are presented in Table 7. The Agency does not have
sufficient information to model potential residues of the triazole conjugates in drinking water;
therefore, EPA has used the modeled estimates for 1,2,4-triazole, multiplied by a factor to correct for
differences in molecular weight, in the dietary assessment for the conjugates. The use of modeled
residue values for 1,2,4-triazole as a surrogate for residues of the triazole conjugates in drinking water
is highly conservative. Additional details regarding the drinking water assessment for the free
19
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triazoles may be found in the February 28, 2006 document, 1,2,4-Triazole, Triazole Alanine, Triazole
Acetic Acid: Drinking Water Assessment in Support ofReregistration and Registration Actions for
Triazole-derivative Fungicide Compounds, which is in docket EPA-HQ-OPP-2005-0497.
Tabic 7. Estimated Drinking Water Concentrations of Free Tr
iazolcs
Crop Scenario
Region Modeled
PCA
Estimated Drinking Water
Concentration (EDWC), ppm
Screening-Level Model
Acute
Chronic
Used in Assessment
Surface Water
Turf
Pennsylvania golf
course
N/A
0.041
0.011
PRZM-EXAMS
Groundwater
Turf
Pennsylvania golf
course
N/A
0.001
0.001
SCI-GROW
b. Residential Exposure and Risk
Residential risk assessments consider all potential nonoccupational exposures other than
exposures from residues in food or drinking water. For propiconazole, EPA evaluated potential
exposure and risk to residential handlers who are mixing, loading, or applying lawn and garden
products or applying paint containing propiconazole with a paint brush, paint roller, or airless sprayer
in and around the home. The Agency also evaluated potential post-application exposure and risk from
adults re-entering treated areas, such as lawns or home gardens to do yard work and from children
who may be either touching treated wood in decks or playsets, mouthing their hands or various objects
that have contacted treated turf or wood, or eating soil containing pesticide residues. Most residential
exposures, including toddler dermal and incidental oral exposure, are considered to be short-term in
duration because of the infrequent, episodic use associated with homeowner products. However, for
propiconazole, post-application exposure to treated decks and playsets is considered to be both short-
and intermediate-term in duration because wood preservatives must remain on treated wood for
efficacy. In addition, for 1,2,4-triazole, post-application exposure to toddlers ingesting soil containing
pesticide residues is considered to be intermediate-term exposure because of this degradate's long
half-life in soil (-500 days).
To estimate risk from residential use of a pesticide, the Agency calculates a margin of
exposure (MOE), which is the ratio of the NOAEL selected for risk assessment to the exposure. This
MOE is compared to a level of concern, which is the same value as the uncertainty factor (UF) applied
to a particular toxicity study. The standard UF is 100X (10X for interspecies extrapolation and 10X
intraspecies variation), plus any additional safety factors, such as an FQPA SF. An MOE less than the
target MOE, or level of concern, is generally a risk concern to the Agency. As previously mentioned
in this document, the FQPA SF for propiconazole has been reduced to IX; therefore, the Agency's
level of concern is an MOE of 100 for propiconazole. The FQPA SF for the free triazoles, however, is
10X; therefore, the Agency's level of concern is an MOE of 1000 for the free triazoles. Further, for
the free triazoles, some exposure scenarios bear an additional 3X uncertainty factor for the lack of a
NOAEL; in these cases, the Agency's level of concern is an MOE of 3000.
20
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Although propiconazole is registered as a wood preservative for dimensional lumber, it is not
currently marketed for use. To complete reregistration, EPA must evaluate potential exposure and
risk from all registered uses, including short- and intermediate-term post-application exposure to
children playing on decks and play sets built from dimensional lumber treated with propiconazole.
However, the Agency does not have adequate wood surface residue (i.e., wood wipe) data necessary
to conduct a chemical-specific post-application exposure assessment. Therefore, EPA conducted a
high-end deterministic screening-level assessment to estimate potential post-application exposure to
children. The Agency is also requiring a confirmatory wood surface wipe study as part of this RED.
No other residential post-application exposure scenarios were evaluated because use of
propiconazole in paint or caulk is not expected to result in exposure after the caulk and paint have
dried. Although additional homeowner exposure could occur from use of propiconazole as a material
preservative in a variety of consumer products, the technical registrants Syngenta and Janssen, have
requested that propiconazole use on carpet fibers, apparel, and furnishings be deleted from product
labels. The Agency published a Federal Register Notice on March 8, 2006, announcing receipt of this
request. Because no comments were received in response to this Notice, EPA issued cancellation
orders for these uses on May 26, 2006. Therefore, these uses have not been included in the risk
assessment for this RED.
The Agency has evaluated residential exposure and risk associated with the free triazoles
because other triazole fungicides, in addition to propiconazole, are used on residential lawns. EPA has
based the exposure assessment for the free triazoles on the use of triademifon on residential turf
because triademifon is the greatest source of residential exposure of any of the triazole fungicides.
The Agency has evaluated dermal and inhalation exposure to residential handlers, dermal post-
application exposure to adults doing yardwork and to children who may be mouthing their hands or
various objects that have contacted treated or who may be eating soil containing pesticide residues.
As a result of its review, the Agency has determined that there is potential residential exposure to
1,2,4-triazole, but no potential exposure to the triazole conjugates (TA and TAA), because these
compounds are formed within the plant and residues are not available on the leaf surface. As
previously mentioned, residential exposure to toddlers from soil ingestion is considered to be
intermediate-term in duration because 1,2,4-triazole has a long half-life in soil.
Additional details regarding the residential exposure and risk assessments for propiconazole
may be found in the following documents: Propiconazole Occupational and Residential Exposure
Assessment, dated January 31, 2006; Propiconazole Occupational and Residential Exposure
Assessment of Antimicrobial Uses, dated February 1, 2006; Amendment to the Propiconazole
Reregistration Eligibility Decision (RED) Document for Children's Postapplication Exposure to
Treated Structures, dated June 20, 2006; and 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, dated February 7, 2006.
5. Aggregate Risk Assessment for Propiconazole and Free Triazoles
Propiconazole, the other triazole fungicides, and other compounds may be metabolized to the
free triazoles in animals and plants. Therefore, EPA has conducted aggregate risk assessments for
potential food, drinking water, and residential exposure resulting from exposure to propiconazole
21
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parent and from exposure to all sources of the free triazoles. Table 8 lists the aggregate risk
assessments that the Agency has conducted for propiconazole and for the free triazoles (1,2,4-triazole,
triazole alanine, and triazole acetic acid). As previously mentioned, EPA only evaluated two
intermediate-term exposure scenarios for residential use: toddlers ingesting soil containing residues of
1,2,4-triazole and toddlers playing on decks or play sets made from wood treated with propiconazole.
Tabic 8. Summary of Aggregate Risk Assessments Conducted for Propionate and its Dcgradatcs
Exposure Duration
Residues Considered
Propiconazole
1,2,4-Triazole
Triazole Alanine &
Triazolc Acetic Acid
Acute
food + drinking water
food + drinking water
food + drinking water
Short-Term
food + drinking water +
residential*,!
food + drinking water +
residential!
Not assessed, 1,2,4-triazole
assessment is protective!
Intermediate-T erm
food + drinking water +
residential*
food + drinking water +
residential**
Chronic
food + drinking water
food + drinking water
food + drinking water
* Residential exposure to children playing on decks and play sets constructed of propiconazole treated wood.
f Residential exposure to adults from yard work and to children from dermal exposure or from hand-to-mouth or
object-to mouth incidental oral exposure.
* * Residential exposure to toddlers via soil ingestion.
{ Residues of the conjugates are not found on the leaf surface and are therefore not available for dermal exposure or
hand-to-mouth or object-to-mouth incidental oral exposure. Because 1,2,4-triazole is more toxic than the conjugates
the risk assessment for 1,2,4-triazole is protective of the conjugates.
a. Aggregate Risk from Propiconazole
Acute Aggregate Risk. The acute aggregate risk assessment for propiconazole considers
exposure from food and drinking water only because there are no other pathways of acute exposure.
The Agency incorporated the peak estimated drinking water concentations (EDWCs) for
propiconazole into the dietary exposure, using the DEEM software. Total dietary exposure from food
and water was then compared to the aPAD for propiconazole. At the 95th percentile, dietary exposure
to the US population comprised 3% of the aPAD; exposure to infants < 1 year old (the most highly
exposed subgroup) comprised 8% of the aPAD, and exposure to females age 13-49 comprised 2% of
the aPAD. Because total dietary exposure from propiconazole is less than 100% aPAD, acute
aggregate exposure from propiconazole is below the Agency's level of concern.
Short-Term Aggregate Risk. Short-term aggregate exposure takes into account residential
exposure plus average exposure levels to food and drinking water (considered to be a background
exposure level). The highest residential handler exposure scenarios for agricultural (hose-end sprayer)
and antimicrobial use (paint brush/roller) are used for the aggregate exposure assessment. Based on
the residential use pattern, post-application exposure to propiconazole for adults are from dermal
exposure only. Infants and children are expected to be exposed by both the dermal and oral routes
(incidental exposure). This aggregate exposure assessment is considered highly conservative. As
shown in Table 9, MOEs for aggregate short-term risk from food, drinking water, and residential use
range from 120 to 500, and are all below the Agency's level of concern.
22
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The Agency considered short-term risk for residential handlers using propiconazole in home
gardens and for residential handlers using paint containing propiconazole, as well as risk for adults
and children receiving post-application exposure. Short-term MOEs for residential handlers and post-
application exposure to adults and children (toddlers) are all greater than 100 and below EPA's level
of concern and are therefore not presented in Table 9. Combined short-term inhalation and dermal
MOEs for residential handlers range from 120 to 40,000. Short-term post-application dermal MOEs
range from 210 to 410 for toddlers and 350 to 50,000 for adults; post-application incidental oral
MOEs range from 1,100 to 330,000 (children only). The combined short-term dermal and incidental
oral MOE is 170 for children playing on treated lawns and 410 for children playing on decks or play
sets built with lumber treated with propiconazole
Intermediate-Term Aggregate Risk. EPA considered intermediate-term aggregate risk for
propiconazole for toddlers playing on decks or play sets built with lumber treated with propiconazole
who are also receiving background exposure to residues in food and drinking water. The
intermediate-term aggregate risk, which includes post-application exposure children and background
exposure from food and drinking water, is an MOE of 130, as shown in Table 9 below.
Tabic 9. Short- and Intcrmcdiate-Tcr
m Ajjgrcjjatc Risk Estimates for Residential Exposure to
Propiconazole
Exposure Scenario
Level of
Concern
MOE
Food +
Drinking
Water
Combined
Dermal and
Inhalation MOE
Oral MOE
(Incidental
Ingestion)
Aggregate
MOE
Residential Handler (Use on Turf and in Paint)
Hose-end sprayer
100
9700
530
N/A
500
Paint Airless Sprayer
100
9700
120
N/A
120
Residential Post-Application (Residential Turf)
Adult - General high contact activities
100
9700
350
N/A
340
Toddler - General high contact activities*
100
3800
450
4,500
160
Residential Post-Application (Treated Decks and Play sets)
Toddler - General high contact activities**
100
3800
450 (short-term)
150 (int.-term)
5,300 (short-term)
1,800 (int.-term)
288
130
* Toddler general high-contact activities include dermal exposure from playing on treated turf as well as incidental oral
exposure from toddlers mouthing their hands, objects that have come in contact with turf, or ingesting soil containing
residues.
** Post application exposure to toddlers playing on decks & play sets is considered to be both short- and intermediate-term
in duration.
Chronic Aggregate Risk. Because the existing residential uses of propiconazole are not likely
to result in chronic exposure to propiconazole, chronic aggregate includes food and drinking water
only. The dietary exposure from drinking water (derived from screening-level models) has been
included in the DEEM analysis. Because the RfD approach used to evaluate chronic dietary risk is
considered protective of any cancer risk concern, only the results of the chronic analysis is given.
Chronic dietary exposure to the US population comprised 3% of the cPAD, and exposure to infants <
1 year old (the most highly exposed subgroup) comprised 8% of the cPAD, which is below the
23
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Agency's level of concern.
b. Aggregate Risk from Free Triazoles
Acute Aggregate Risk. The acute aggregate risk assessments for 1,2,4-triazole and for the
triazole conjugates triazole alanine and triazole acetic acid only consider exposure from food and
drinking water because there are no other pathways of acute exposure. The Agency incorporated the
peak EDWCs for 1,2,4-triazole and for the triazole conjugates into the dietary exposure, using the
DEEM software. Total dietary exposure from food and drinking water was then compared to the
appropriate aPAD. At the 95 percentile of exposure, acute dietary exposure for children age 1-2
years (the most highly exposed population) comprised 32% of the aPAD for 1,2,4-triazole. For the
triazole conjugates, the toxicological endpoint is only relevant to females of childbearing age. The
DEEM results for the triazole conjugates showed that females age 13-49 years had dietary exposure at
the 95th percentile comprising 27% of the aPAD. Therefore, acute aggregate risk for the free triazoles
is below EPA's level of concern.
Short-Term Aggregate Risk. For 1,2,4-triazole, the short-term aggregate risk assessment
considers worst-case residential exposure from triademifon, the triazole fungicide with the highest
application rate on residential lawns, combined with background exposure from food and drinking
water. The residential risk assessment for the triazoles includes the following exposure scenarios:
adult handlers applying pesticide with a hose end sprayer or low-pressure hand wand, post-application
exposure to adults and toddlers from dermal contact or incidental oral exposure from soil ingestion or
from mouthing hands or objects that have contacted treated turf. Short-term dermal MOEs for
residential handlers exposed to 1,2,4-triazole (from use of triademifon) range from 3,500 for children
to 3,900 for adults. Short-term incidental oral MOEs for children are 7,300 for hand-to-mouth
exposure and 30,000 for object-to-mouth exposure. Because all of these MOE values are above 1000,
residential risks for 1,2,4-triazole are below the Agency's level of concern.
Short-term aggregate MOEs for 1,2,4-triazole range from 1,900 to 4,000 for all population
subgroups. These MOEs, which consider potential residential exposure with background exposure
from food and drinking water, are all greater than the target MOE of 1,000, and below the Agency's
level of concern. The Agency believes that there is no potential residential exposure to the triazole
conjugates (TA and TAA) because these compounds are formed within the plant and residues are not
available on the leaf surface. Although residues of the triazole conjugates may also be available in
soil, the risk assessment for soil ingestion of 1,2,4-triazole is believed to be protective because 1,2,4-
triazole is more toxic than the triazole conjugates. Therefore, short-term aggregate risks for the free
triazoles are below EPA's level of concern.
Intermediate-Term Aggregate Risk. For 1,2,4-triazole, the intermediate-term aggregate risk
assessment considers potential exposure to children via soil ingestion combined with background
exposure from food and drinking water. The intermediate-term MOE for children receiving incidental
oral exposure via soil ingestion is 1,600,000, which is below the Agency's level of concern.
Intermediate-term aggregate MOEs range from 7,600 to 28,000 for all population subgroups, and are
all greater than 3000, the Agency's level of concern for intermediate-term MOEs. Because the risk
assessment for soil ingestion of 1,2,4-triazole is believed to be protective of the triazole conjugates, the
intermediate-term aggregate risks for the free triazoles are all below the Agency's level of concern.
24
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Chronic Aggregate Risk. As with the acute aggregate risk assessments, the chronic aggregate
risk assessments for 1,2,4-triazole and for the triazole conjugates only consider exposure from food
and drinking water because there are no other pathways of chronic exposure. Chronic dietary
exposure from food and drinking water for the most highly exposed subpopulation, children age 1-2
years comprised 39% of the cPAD for 1,2,4-triazole and 27% of the cPAD for the triazole conjugates.
Therefore, chronic aggregate risks for the free triazoles are below EPA's level of concern.
c. Pesticide and Pharmaceutical Assessment for Free 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 Food and Drug
Administration (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, propiconazole shares a common metabolite, 1,2,4-triazole, with
several 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 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
25
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summarizing EPA and FDA discussions on potential free triazole metabolites of traizole derivative
drugs, (both available in the public docket for propiconazole, EPA-HQ-OPP-2005-0497) for
additional information.
6. Occupational Exposure and Risk
Workers can be exposed to a pesticide through mixing, loading, and/or applying the pesticide;
these workers are called pesticide "handlers." Workers can also be exposed to residues of a pesticide
when re-entering treated areas. For dermal and inhalation exposures, worker risk is estimated by a
Margin of Exposure (MOE) which determines how close the occupational exposure comes to the No
Observed Adverse Effect Level (NOAEL) selected from animal studies. Based on the use pattern for
propiconazole and the toxicological database for propiconazole, the Agency has determined that
short- and intermediate-term (but not lifetime) exposures should be included in the risk assessment.
The toxicological endpoints used in the occupational risk assessment are presented in Table 3 of this
document, and EPA assumed 40% dermal absorption based on an animal study.
The Agency typically evaluates exposure to pesticide handlers using different levels of personal
protective equipment (PPE). EPA typically conducts an initial exposure assessment assuming
baseline clothing, and then adds PPE in a tiered approach to determine the level of additional PPE
necessary to obtain appropriate MOEs. This approach is allows the Agency to determine the
appropriate PPE and other label language using a risk-based approach.
In the handler exposure assessments for propiconazole, EPA evaluated the following clothing
scenarios:
• baseline, which consists of long-sleeve shirt, and long pants but no gloves or respirator,
• baseline plus chemical-resistant gloves, and
• engineering controls (for antimicrobial uses only).
All current propiconazole labels for agricultural use require baseline PPE plus chemical-resistant
gloves; labels registered for antimicrobial use products also require baseline PPE, chemical-resistant
gloves, and protective eyewear.
Because propiconazole is used both in agricultural and antimicrobial sites, the Agency
conducted separate assessments for these sites. Additional details regarding the occupational exposure
and risk assessments for propiconazole may be found in the following documents: Propiconazole
Occupational and Residential Exposure Assessment, dated January 31, 2006 and Propiconazole
Occupational and Residential Exposure Assessment of Antimicrobial Uses, dated February 1, 2006.
a. Handler Exposure and Risk
Agricultural Uses of Propiconazole. The exposure and risk assessment for occupational
handlers addressed the following scenarios: mixer/loader, applicator, and flagger. These scenarios
were used to estimate exposures based on application of the formulations of propiconazole currently
registered for use in agriculture (i.e., wettable powder (water soluble packs) and liquid). As
previously mentioned, EPA evaluated both short- and intermediate-term occupational exposures and
risks.
26
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For agricultural scenarios, no chemical-specific handler data were available for propiconazole,
so EPA used unit exposure values from the Pesticide Handlers Exposure Database (PHED) to
estimate handler exposures. The Agency used standard default assumptions for the number of acres
treated per day, worker body weight, hours worked, etc., for most handler scenarios.
For liquid formulations, handler risks for most scenarios were above EPA's level of concern
(i.e., MOEs < 100) for mixer/loaders, both short- and intermediate-term exposure, with baseline
clothing (long sleeve shirt, long pants, shoes and socks, but no gloves). However, these same handler
risks were below the Agency's level of concern (MOEs > 100) with the addition of chemical-resistant
gloves.
For wettable powders formulated in water-soluble packs (an engineering control), handler
risks were below the Agency's level of concern (i.e., MOEs > 100) for all scenarios with baseline
clothing. Also, handler risks for mixer/loader/applicators using liquid formulations and high- or low-
pressure handwand, handgun sprayer, or seed piece dip were below the Agency's level of concern
both at baseline and with gloves. Applicator and flagger risks were below EPA's level of concern
(i.e., MOEs > 100) for all formulations with baseline clothing. Handler risk estimates for the
agricultural uses of propiconazole are presented in Table 10.
27
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Tabic 10. Short- and Intcrmcdiatc-Tcrm Handler Risk Estimates for Agricultural Uses of Propiconazolc
Margin of Exposure (MOE)
Exposure
Scenario
Crops
Appl. Rate
(lb ai/acrc or
Area Treated
(acre/day)
Short-Term Exposure
I ntcrmcd iatc-T crm
Exposure
lb ai/gallon)
Baseline*
Baseline
+ Gloves
Baseline*
Baseline
+ Gloves
Mixer/Loader - Liquid
Aerial
Barley, Rye, Oats, Wheat, Corn, Sunflower
0.1125
1200
13
1500
4.5
500
Celery, Stone Fruits (Apricots, Cherry, Nectarine, Peach, Plum), Mint,
Triticale
0.1125
350
46
5100
15
1700
Non-bearing Citrus, Pecans, Non-bearing Hazelnuts, Peanuts
0.225
350
23
2600
7.7
850
Grasses grown for seed (forage and fodder grasses), Wild Rice
0.225
350
23
2600
7.7
850
Sod-farm turf
1.8
350
2.9
320
1.0
110
Wheat
0.08
1200
19
2100
6.3
700
Rice
0.28
1200
5.4
600
1.8
200
Groundboom
Barley, Rye, Oats, Wheat, Corn, Sunflower
0.1125
200
80
9000
27
3000
Celery, Stone Fruits (Apricots, Cherry, Nectarine, Peach, Plum), Mint,
Triticale
0.1125
80
200
22000
67
7500
Non-bearing Citrus, Non-bearing Hazelnuts, Pecans, Peanuts
0.225
80
100
11000
33
3700
Grasses grown for seed (forage and fodder grasses)
0.225
80
100
11000
33
3700
Sod farm turf
1.8
80
13
1400
4.2
470
Golf Course turf
40
25
2800
8.4
930
Wheat
0.08
200
110
13000
38
4200
Airblast
Pecans, Non-bearing Citrus
0.225
40
200
22000
67
7500
Stone Fruits (Apricots, Cherry, Nectarine, Peach, Plum)
0.1125
40
400
45000
130
15000
Ornamental (Flowering and Woody plants)
0.37
40
120
14000
41
4500
Bananas and Plantains
0.084
40
540
60000
180
20000
Chemigation
Barley, Rye, Oats, Wheat, Corn, Sunflower, Celery
0.1125
350
46
5100
15
1700
Grasses grown for seed (forage and fodder grasses), Non-bearing citrus,
Peanut
0.225
350
23
2600
7.7
850
Wheat
0.08
350
65
7200
22
2400
Rice
0.28
350
18
2100
6.2
690
Handgun
Sprayer
Turf
1.8
100
10
1100
3.3
370
28
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Tabic 10. Short- and Intcrmcdiatc-Tcrm Handler Risk Estimates for Agricultural Uses of Propiconazolc
Margin of Exposure (MOE)
Exposure
Scenario
Crops
Appl. Rate
(lb ai/acrc or
Area Treated
(acre/day)
Short-Term Exposure
I ntcrmcd iatc-T crm
Exposure
lb ai/gallon)
Baseline*
Baseline
+ Gloves
Baseline*
Baseline
+ Gloves
Mixer/Loader - Wettable Powder in Water Soluble Packets
Barley, Rye, Oats, Wheat, Corn, Sunflower
0.1125
1200
1800
N/A**
600
N/A
Aerial
Celery, Stone Fruits (Apricots, Cherry, Nectarine, Peach, Plum), Mint,
Triticale
0.1125
350
6200
N/A
2100
N/A
Non-bearing Citrus, Pecans, Non-bearing Hazelnuts, Peanuts
0.225
350
3100
N/A
100
N/A
Grasses grown for seed (forage and fodder grasses), Wild rice
0.225
350
3100
N/A
100
N/A
Aerial
Sod-farm turf
1.8
350
390
N/A
130
N/A
Wheat
0.08
1200
2500
N/A
840
N/A
Rice
0.28
1200
720
N/A
240
N/A
Barley, Rye, Oats, Wheat, Corn, Sunflower
0.1125
200
11000
N/A
3600
N/A
Celery, Stone Fruits (Apricots, Cherry, Nectarine, Peach, Plum), Mint,
Triticale
0.1125
80
27000
N/A
9000
N/A
Groundboom
Non-bearing Citrus, Non-bearing Hazelnuts, Pecans, Peanuts
0.225
80
14000
N/A
4500
N/A
Grasses grown for seed (forage and fodder grasses)
0.225
80
14000
N/A
4500
N/A
Sod Farm turf
1.8
80
1700
N/A
560
N/A
Golf Course turf
40
3400
N/A
110
N/A
Wheat
0.08
200
15000
N/A
5100
N/A
Pecans, Non-bearing Citrus
0.225
40
27000
N/A
9000
N/A
Airblast
Stone Fruits (Apricots, Cherry, Nectarine, Peach, Plum)
0.1125
40
54000
N/A
18000
N/A
Ornamental (Flowering and Woody plants)
0.37
40
16000
N/A
5500
N/A
Bananas and Plantains
0.084
40
72000
N/A
24000
N/A
Barley, Rye, Oats, Wheat, Corn, Sunflower, Celery
0.1125
350
6200
N/A
2100
N/A
Chemigation
Grasses grown for seed (forage and fodder grasses), Non-bearing citrus,
Peanut
0.225
350
3100
N/A
1000
N/A
Wheat
0.08
200
8700
N/A
2900
N/A
Rice
0.28
350
2500
N/A
830
N/A
Handgun
Sprayers
Turf
1.8
100
1400
N/A
450
N/A
29
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Tabic 10. Short- and Intcrmcdiatc-Tcrm Handler Risk Estimates for Agricultural Uses of Propiconazolc
Margin of Exposure (MOE)
Exposure
Scenario
Crops
Appl. Rate
(lb ai/acrc or
Area Treated
(acre/day)
Short-Term Exposure
I ntcrmcd iatc-T crm
Exposure
lb ai/gallon)
Baseline*
Baseline
+ Gloves
Baseline*
Baseline
+ Gloves
Applicator
Barley, Rye, Oats, Wheat, Corn, Sunflower
0.1125
1200
7500
16000
2500
5500
Celery, Stone Fruits (Apricots, Cherry, Nectarine, Peach, Plum), Mint,
Triticale
0.1125
350
26000
56000
8600
19000
Aerial
Non-bearing Citrus, Pecans, Non-bearing Hazelnuts, Peanuts
0.225
350
31000
28000
4300
9400
Grasses grown for seed (forage and fodder grasses), Wild rice
0.225
350
31000
28000
4300
9400
Sod-farm turf
1.8
350
1600
3500
540
1200
Wheat
0.08
1200
11000
23000
3500
7700
Rice
0.28
1200
3000
6600
1000
2200
Barley, Rye, Oats, Wheat, Corn, Sunflower
0.1125
200
15000
15000
4900
4900
Groundboom
(Open Cab)
Celery, Stone Fruits (Apricots, Cherry, Nectarine, Peach, Plum), Mint,
Triticale
0.1125
80
37000
37000
12000
12000
Non-bearing Citrus, Non-bearing Hazelnuts, Pecans, Peanuts
0.225
80
18000
18000
6100
6100
Grasses grown for seed (forage and fodder grasses)
0.225
80
18000
18000
6100
6100
Sod Farm turf
1.8
80
2300
2300
770
770
Wheat
0.08
200
21000
21000
6900
6900
Pecans, Non-bearing Citrus
0.225
40
1600
2300
520
770
Airblast
Stone Fruits (Apricots, Cherry, Nectarine, Peach, Plum)
0.1125
40
3100
4600
1000
1500
Ornamental (Flowering and Woody plants)
0.37
40
960
1400
320
470
Bananas and Plantains
0.084
40
4200
6200
1400
2100
30
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Tabic 10. Short- and Intcrmcdiatc-Tcrm Handler Risk Estimates for Agricultural Uses of Propiconazolc
Margin of Exposure (MOE)
Exposure
Scenario
Crops
Appl. Rate
(lb ai/acrc or
Area Treated
(acre/day)
Short-Term Exposure
I ntcrmcd iatc-T crm
Exposure
lb ai/gallon)
Baseline*
Baseline
+ Gloves
Baseline*
Baseline
+ Gloves
Flagger
Barley, Rye, Oats, Wheat, Corn, Sunflower
Celery, Stone Fruits (Apricots, Cherry, Nectarine, Peach, Plum), Mint,
Triticale
0.1125
350
11000
N/A
3700
N/A
Aerial
Non-bearing Citrus, Pecans, Non-bearing Hazelnuts, Peanuts
0.225
350
5600
N/A
1900
N/A
applications
Grasses grown for seed (forage and fodder grasses), Wild rice
Sod-farm turf
1.8
350
700
N/A
230
N/A
Wheat
0.08
350
16000
N/A
5300
N/A
Rice
0.28
350
4500
N/A
1500
N/A
Mixer/Loader/Applicator (Liquid formulations)
High
Pressure
Handwand
Non-bearing Fruits and Nuts, Ornamental Woody and Flowering plants
0.0024
1000 gal
handled/day f
N/A
780
N/A
260
Low
Pressure
Handwand
Non-bearing Fruits and Nuts, Ornamental Woody and Flowering plants
40 gal
handled/day
550
110000
180
36000
Handgun
Sprayer
Turf
1.8
5
N/A
12000
N/A
390
Seed Piece
Dip
Sugarcane (HI only)
0.00021
1000 gal
handled/day
8600
960000
2900
320000
MOE = NOAEL/Daily Dose where the NOAEL for both dermal and inhalation is 30.0 mg/kg/day for Short-term and 10.0 mg/kg/day for Intermediate-term exposures.
The target MOE is 100 for both short- and intermediate-term occupational exposures. * Baseline clothing consists of long sleeve shirt, long pants, shoes and socks but no gloves or
respirator. N/A - not applicable. **Gloves are not considered for scenarios with engineering controls, such as wettable powders with water soluble bags or aerial application with
closed cockpit, f Amount handled is described as gal/day rather than area treated for high and low pressure handwand and seed piece treatment MOEs in bold are above EPA's
level of concern.
31
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Antimicrobial Uses ofPropiconazole. As previously mentioned, propiconazole is registered
for use as both a material preservative (in adhesives, caulk, paints, textiles, and metalworking fluid),
and as a wood preservative. Occupational handler exposure can occur when a worker is adding
preservative to treated materials. The exposure and risk assessment for occupational handlers
addressed the following scenarios:
(1) Material Preservative
• Liquid pour (transfer of antimicrobial from a small container to an open vat),
• Liquid pump (transfer of antimicrobial to a closed tote via a chemical metering pump
or gravity flow),
• Paint application by brush, roller, or airless sprayer; and
(2) Wood Preservative
• Blender spray operators
• Chemical operators
• Diptank operators
• High pressure/high volume spray
o Wood treatment
o Mushroom houses
o Cooling towers
• Pressure treatment of wood
These scenarios were used to estimate exposures based on application of the formulations of
propiconazole currently registered for antimicrobial use. The Agency evaluated both short- and
intermediate-term occupational exposures and risks for these use scenarios. Table 11 provides a
summary of short- and intermediate-term handler MOEs for antimicrobial uses.
Material Preservative. For use of propiconazole as a material preservative, combined
inhalation and dermal total short-term handler MOEs range from < 1 to 6,500 at baseline (long-
sleeved shirt, long pants, shoes and socks) and from 300 to 26,000 with the addition of chemical-
resistant gloves. Likewise, intermediate-term handler MOEs range from < 1 to 2,200 at baseline and
100 to 8,600 with chemical-resistant gloves. Worker risks are of concern for workers applying paint
containing propiconazole as an in-can preservative under the following scenarios:
• Painting with brush/roller or airless sprayer - combined intermediate-term MOE of 55, at
baseline, and
• Painting with airless sprayer - combined short-term MOE of 75 and intermediate-term MOE
of 25, at baseline.
Wood Preservative. For blender/spray operators, chemical operators, and diptank operators
wearing gloves, short-term combined MOEs range from 400 to 850 and intermediate-term MOEs
range from 130 to 280. Handler MOEs for high-pressure/high volume spray treatment range from
150 to 1,500 for short-term exposure and from 50 to 500 for intermediate-term exposure; again, these
MOEs assume that chemical-resistant gloves are worn. The MOE of 50 is for application of
propiconazole to mushroom houses in a high volume spray of 1000 gallons per day. For workers
pressure treating wood, the combined short-term MOE ranges from 260 to 2,200 and the intermediate-
term MOE ranges from 86 to 730 with gloves.
32
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Tabic 11. Short- and Intcrmcdiatc-Tcrm Handler Risk Estimates for Antimicrobial Uses of Propiconazolc
i i Amount
. .. .. i Appl. i Handled
MOEs for Short-Term Exposure
MOEs for Intcrmcdiatc-Tcrm Exposure
Dermal
Inhal.
Total
Dermal
Inhal.
Total
Use Site
Method
Rate (%
ai by wt)
or
Treated
per Day
Baseline
Gloves
Baseline
Gloves
Baseline
Gloves
Baseline
Gloves
MATERIAL PRESERVATIVE
Adhesives
Liquid Pour
1.21
10,000
lbs
<1
320
4,300
<1
300
<1
110
1,700
<1
100
Liquid
Pump
95
6,900
37,000
95
5,900
32
2,200
14,000
32
2,000
Metal
Working
Fluids
Liquid Pour
0.07
2,500 lbs
60
16,000
120,000
60
15,000
20
5,400
47,000
20
4,900
Liquid
Pump
6,600
9,600
300,000
6,500
9,300
2,200
3,200
110,000
2,200
3,100
Paint
Liquid Pour
0.35
2,000 lbs
15
5,600
74,000
15
5,200
5
1,900
29,000
5
1,700
Liquid
Pump
0.35
10,000
lbs
330
24,000
130,000
330
21,000
110
7,900
50,000
110
6,900
Textiles
Liquid Pour
0.28
10,000
lbs
4
1,400
19,000
4
1,300
1
460
7,200
1
440
Liquid
Pump
410
30,000
160,000
410
26,000
140
9,900
62,000
140
8,600
Professional Application of Paint
Paint
Brush/
Roller
0.35
50 lbs
170
N/A*
37,000
170
N/A*
56
N/A*
14,000
55
N/A*
Airless
Sprayer
0.35
500 lbs
79
N/A*
1,200
75
N/A*
26
N/A*
480
25
N/A*
WOOD PRESERVATIVE
Blender/
Spray Operator
0.5
178,000
N/A
940
5,900
N/A
810
N/A
310
2,000
N/A
270
1.0
178,000
N/A
470
2,900
N/A
400
N/A
160
980
N/A
130
Chemical Operator
N/A
N/A
860
120,000
N/A
850
N/A
290
40,000
N/A
280
Diptank Operator
0.5
N/A
3,500
N/A
91,000
3,400
N/A
1,200
N/A
30,000
1,100
N/A
1.0
N/A
1,800
N/A
46,000
1,700
N/A
580
N/A
15,000
560
N/A
High Pressure/High Volume Spray Treatment
Wood Treatment
25 gal/day
N/A
580
4,800
N/A
510
N/A
190
1,600
N/A
170
50 gal/day
N/A
290
2,400
N/A
260
N/A
96
800
N/A
86
Mushroom House
100 gal/day
N/A
1,700
14,000
N/A
1,500
N/A
560
4,700
N/A
500
1000 gal/day
N/A
170
1,400
N/A
150
N/A
56
470
N/A
50
33
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Tabic 11. Short- and Intcrmcdiatc-Tcrm Handler
Risk Estimates for Antimicrobial Uses of Propiconazole
Amount
MOEs for Short-Term Exposure
MOEs for Intcrmcdiatc-Tcrm Exposure
Application
Method
Appl.
Handled
Dermal
Total
Dermal
Total
Use Site
Rale (%
ai by wt)
or
Treated
per Day
Baseline
Gloves
Inhal.
Baseline
Gloves
Baseline
Gloves
Inhal.
Baseline
Gloves
100 gal/day
N/A
970
8,100
N/A
870
N/A
520
2,700
N/A
290
Cooling Tower
200 gal/day
N/A
490
4,100
N/A
430
N/A
160
1,400
N/A
140
Pressure Treatment
Treatment Operator
1
N/A
N/A
260
82,000
N/A
260
N/A
86
27,000
N/A
86
Treatment Assistant
1
N/A
N/A
2,200
260,000
N/A
2,200
N/A
730
87,000
N/A
730
N/A- not applicable. * Gloves are not applicable to painters because paint products containing propiconazole are not labeled as pesticides (i.e., propiconazole is used as an in-can
preservative).
MOEs in bold are above EPA's level of concern.
34
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b. Post-Application Exposure and Risk
The post-application occupational risk assessment for propiconazole considers exposure to
agricultural workers re-entering areas previously treated with propiconazole as well as post-
application exposure from use of propiconazole as a wood preservative. EPA identified a variety of
post-application exposure scenarios by the type of activity (i.e., weeding, scouting, or hand
harvesting crops; grading or stacking treated lumber; operating chemical equipment, trim saws, etc.)
and the expected level of contact. Post-application exposure levels can vary over time according to
the type of worker activity, the dissipation of chemical residues over time, and the nature of the crop
or item that was treated. The Agency estimated post-application exposure and risk using
dislodgeable foliar residue (DFR), turf transferable residue (TTR), and/or other dissipation or post-
application monitoring data, as appropriate.
Agricultural Uses. Post-application exposure for agricultural uses of propiconazole was
evaluated using chemical-specific DFR/TTR data. A total of six residue dissipation studies are
available for corn, peaches, rice, pecans, ornamentals and turf. The DFR data have been
extrapolated to similar crops. The turf TTR data have been used to complete all assessments for
turf: sod-farm, recreational areas and golf courses. EPA used interim transfer coefficients derived
from Agricultural Re-entry Task Force (ARTF) data according to current Agency policy.
Worker post-application risks for agricultural uses are summarized in Table 12. All
occupational post-application short- and intermediate-term risks are below the Agency's level of
concern on the day of pesticide application (i.e., MOEs > 100 on day 0) except for hand-harvesting
cut flowers on day 0. The MOE for hand-harvesting cut flowers is 97 on day 0 but is 104 one day
after treatment. Although the MOE on is slightly less than 100 on day 0, the MOE of 97 is within
the negligible risk range, and thus below EPA's level of concern. The current restricted-entry
interval (REI) for propiconazole is 12 hours on some labels; which is consistent with the Worker
Protection Standard (WPS) requirement based on the acute toxicity of technical propiconazole
(Toxicity Category III). The propiconazole REI will remain 12 hours unless otherwise indicated by
product-specific toxicity data.
Tabic 12. Summary of Post-application Worker Risk Estimates for Agricultural Uses of Propiconazole
Crop
Activity
T ransfcr
Coefficient
(cm2/hr)
Maximum
Application
Rate (lb ai/A)
MOE on Day of Application
(Ikiy 0)
Short-Term
Exposure
Intermediate -
Term Exposure
Celery, Mint, Wild
irrigating, scouting, hand-
weeding
100
36000
12000
rice, (MN only),
Barley, Oats, Rye,
irrigating, scouting
1500
0.28
2400
800
Wheat, Rice, Peanuts
hand-harvesting
2500
1400
500
35
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Tabic 12. Summary of Post-application Worker Risk Estimates for Agricultural Uses of Propiconazolc
Crop
Activity
T ransfcr
Coefficient
(cm2/hr)
Maximum
Application
Rate (lb ai/A)
MOE on Day of Application
(Ikiy 0)
Short-Term
Exposure
Intermediate -
Term Exposure
Corn (field, pop,
sweet), Sunflower
hand-weeding
100
110000
37000
irrigating, scouting
1000
0.1125
1100
3700
De-tasseling, hand-
harvesting
17000
700
220
Stone Fruits, Peaches,
Non-bearing Apples,
irrigating, scouting
1000
2600
860
hand-weeding, hand
harvesting, hand-pruning,
1500
0.1125
1700
570
Thinning
3000
860
290
Non-bearing Citrus
irrigation, scouting, hand-
weeding
1000
0.225
1300
430
hand-pruning, thinning
3000
430
140
irrigation, hand-weeding
100
35000
12000
Bananas, Plantains
scouting, irrigation
1300
0.084
2700
900
hand-harvesting,, thinning,
hand-weeding/ pruning
2000
1700
600
Non-bearing
Blueberries
scouting, hand-weeding/
pruning, irrigation, thinning
400
0.169
4300
1400
hand-pruning
1500
1200
380
pruning, tying
110
7100
2040
Ornamentals (Woody
and Herbaceous) plants
transporting, moving potted
plants
400
2000
560
hand-harvesting
(cut flowers)
Short-term
5100
0.37
150
97
Intermediate-
term
2700
170
104
Pecans, Non-bearing
Hazelnuts
hand-weeding, thinning,
irrigating, scouting
500
0.225
5200
1700
Hand-pruning, thinning
2500
1000
340
Turf
(grasses grown for
seed, golf courses,
sod farms)
Turf maintenance
3400
1.8
1800
600
hand-weeding/harvesting
transplanting, hand-harvest
mechanical harvesting
6800
1.8
900
300
36
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Antimicrobial Uses. EPA evaluated post-application to machinists using metalworking
fluids containing propiconazole and to sawmill workers handling lumber treated with
propiconazole. Exposure to machinists was estimated using the best available information. Dermal
exposure was simulated using the hand-immersion model ChemSTEER, which considers percent
active ingredient and film thickness. Inhalation exposure was estimated using the Occupational
Safety and Health Administration (OSHA) permissible exposure limit (PEL) for oil mist. Post-
application worker exposure for antimicrobial use of propiconazole as a wood preservative was
evaluated using surrogate data from a study based on another wood preservative, DDAC, which
measured worker exposure performing routine tasks at several sawmills/planar mills in Canada.
The DDAC study monitored both inhalation and dermal exposure. EPA also used surrogate data
from a study on chromated copper arsenic (CCA) conducted by the American Chemistry Council.
This study monitored both inhalation and dermal exposure during post-application activities such as
stacker operator and loader operator. MOEs for post-application worker exposure to metalworking
fluids and wood preservatives are summarized in Table 13.
Tabic 13. Summary of Post-application Worker Risk Estimates for Propiconazole Used in Metalworking
Fluids and Wood Preservative
Worker Activity
MOE for Short-Term Exposure
on Day of Application
' (Day 0)
MOE for Intcrmcdiatc-/Long-Tcrm Exposure
on Day of Application
' (Day 0)
Dermal
Inhalation
Total
Dermal
Inhalation
Total
Metalworking Fluid
Machinist
5,100
75,000
4,800
1,700
25,000
1,600
Wood Preservative
Grader
2,700
110,000
2,600
890
38,000
870
Trim Saw Operator
6,100
56,000
5,500
2,000
19,000
1,800
Millwright
660
59,000
650
220
20,00
220
Clean Up Crew
150
5,600
150
51
1,900
49
Pressure Treatment -
all scenarios
710
130,000
710
240
44,000
240
MOEs in bold are above EPA's level of concern.
c. Incident Reports
The Agency reviewed available sources of human incident data for incidents relevant to
propiconazole. The following sources were used: 1) The Office of Pesticide Programs' (OPP)
Incident Data System (IDS) consisting of reports submitted to EPA by registrants, other federal and
state health and environmental agencies and the public since 1992; 2) Poison Control Center Data
covering the years 1993 through 2003 for all pesticides; 3) California Department of Pesticide
Regulation's pesticide poisoning surveillance program consisting of reports from physicians of
37
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illness suspected of being related to pesticide exposure since 1982; 4) National Pesticide
Information Center (NPIC) data that provides a ranking of the top 200 active ingredients for which
telephone calls were received between 1984 and 1991; and 5) National Institutes of Occupational
Safety and Health (NIOSH) Sentinal Event Notification System for Occupational Risks (SENSOR)
that provides surveillance in seven states from 1998 through 2002. EPA's review of the human
incident data for propiconazole can be found in the July 26, 2005 document, Review of
Propiconazole Incident Reports.
All of the sources listed above, except for NPIC, contained information relevant to
propiconazole. The IDS contained numerous incidents, most of which involved symptoms such as
skin rash, itching, and irritation and respiratory effects such as difficulty breathing. However, this
database contained little information about the disposition of the reported cases. Reports submitted
to the IDS represent anecdotal reports or allegations. Poison Control Center Data listed 13
occupational exposure incidents among adults and older children, 63 nonoccupational exposure
incidents among adults and older children, and 13 exposures to children under 6 years old. Only a
small number of these incidents required treatment in a health care facility, and none were
considered life threatening or required hospitalization. The most common symptoms reported were
headache, skin irritation, erythema, vomiting, ataxia, dizziness, coughing, and difficulty breathing.
In general, in comparison to other pesticides for which Poison Control Center Data are available,
propiconazole appears to be less hazardous with less than one percent of reported propiconazole
cases being symptomatic, compared to approximately 70% of all pesticide cases. The Agency also
reviewed detailed descriptions of 13 cases submitted to the California Pesticide Illness Surveillance
Program, and propiconazole was deemed to be the responsible for health effects in 8 of these cases.
Reported symptoms included difficulty breathing, eye and skin irritation, headache and vomiting.
Propiconazole was not reported on the list of the top 200 chemicals with incidents reported to
NPIC. Propiconazole was associated with two cases out of a total of 4,221 cases reported to
NIOSH SENSOR between 1998 and 2002. Both cases were as a result of drift; symptoms included
nausea, vomiting, gastrointestinal pain, difficulty breathing, and throat irritation.
In general, in conclusion from the review of the IDS, it appears that a majority of cases
involved skin symptoms such as rash, itching, skin irritation and respiratory effects. Poison Control
Center Data tends to support the IDS results with dermal irritation, erythema, and difficulty
breathing being among the most common effects reported.
B. Environmental Fate and Effects Risk Assessment
A summary of the Agency's environmental fate and effects risk assessment is presented
below. For detailed discussion of all aspects of the environmental risk assessment, please see the
documents, Environmental Fate and Effects Division Risk Assessment for the Reregistration of
Propiconazole, dated November 29, 2005, Environmental Fate and Effects Division Revised RED
for the Reregistration of Propiconazole, dated June 30, 2006, and Terrestrial Plant Runoff Risk
Assessment for Propiconazole on Turf Using PRZM, dated July 14, 2006. These documents are
available on the internet (www.regulations.gov) and in the public docket under docket number
EPA-HQ-OPP-2005-0497. This risk assessment was refined and updated to incorporate public
comments submitted during Phase 3 of the public participation process and additional studies
submitted by the registrant. Major changes to the risk assessment include the following:
38
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• Incorporation of information on dissipation and degradation of propiconazole in the
environment,
• Revision of estimated environmental concentrations (EECs) for propiconazole in
water for wheat and rice and in various food items for turf and rice,
• Use of EPA's T-REX Model to estimate risk quotients (RQs) for birds and
mammals; and
• Revision of Risk Quotients (RQs) for aquatic and terrestrial organisms.
1. Environmental Fate and Transport
Propiconazole appears to be persistent and moderately mobile to relatively immobile in
most soil and aqueous environments. Propiconazole degradation in the aquatic environment
appears to be dependent solely on aqueous photolysis in the presence of photo sensitizers that are
quite common in photolysis studies. In soil environments, propiconazole dissipation appears to be
dependent on incorporation or binding to soil organic matter content.
Laboratory and terrestrial field dissipation data indicate that propiconazole is stable in soil
and aqueous environments. Propiconazole was stable to hydrolysis; aqueous photolysis; soil
photolysis; aerobic aquatic metabolism, aerobic soil metabolism, and anaerobic aquatic metabolism.
The terrestrial field dissipation data were consistent with laboratory data with reported half-lives of
greater than 100 days for four soil textures. However, in supplemental aquatic dissipation studies
using basin irrigation and flow-through irrigation systems in rice fields, propiconazole was found to
dissipate rapidly with a half-life of less than 5 days. Aqueous photolysis studies using sensitizers
indicated rapid degradation with a half-life of less than 1 day for propiconazole, which appears to
also be the case in rice fields. Furthermore, aquatic metabolism and dissipation studies indicate
propiconazole dissipates by incorporation of binding to the organic matter content of soil/sediment.
Propiconazole mobility in soil appears to be dependent on the soil's organic matter content.
In general, propiconazole appears to be moderately mobile in soils with low organic matter content
and relatively immobile in soils with high organic matter content. Therefore, propiconazole may
reach groundwater in soils with low organic content. More importantly, propiconazole may
contaminate surface water through off-site runoff and spray drift.
2. Ecological Exposure and Risk
To estimate potential ecological risk, EPA integrates the results of exposure and ecotoxicity
studies using the risk quotient method. Risk quotients (RQs) are calculated by dividing acute and
chronic 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 14 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
39
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potential for adverse effects to non-target organisms. For a more detailed explanation of the
ecological risks posed by the use of propiconazole, refer to the document, Environmental Fate and
Effects Division Revised RED for the Reregistration of Propiconazole, dated June 30, 2006.
Tabic 14. EPA's Levels ot'Conecrn (LOCs) and Risk Presumptions
If a calculated RQ is greater than the LOC presented, then the Agency presumes
that...
LOC
terrestrial
animals
LOC
aquatic
animals
LOC
Plants
Acute Risk.. .there is potential for acute risk; regulatory action may be warranted
0.5
0.5
1.0
Acute Listed (Endangered and Threatened) Species ...listed species maybe
adversely affected
0.1
0.05
1.0
Chronic Risk .. .there is potential for chronic risk
1
1
NA
a. Terrestrial Organisms
Exposure to Birds and Mammals. The Agency assessed exposure to terrestrial organisms
by first predicting the amount of propiconazole residues found on animal food items and then by
estimating the amount of pesticide consumed by using information on typical food consumption by
various species of birds and mammals. The amount of residues on animal feed items are based on
the Fletcher nomogram (a model developed by Fletcher, Hoerger, Kenaga, et al.), a default half-life
of 35 days and/or a chemical-specific foliar dissipation half-life, the current maximum application
rate for propiconazole, the maximum number of applications per year (when specified), and the
minimum interval between applications. For crops with more than one application, EPA used the
T-REX computer model to account for residue dissipation between pesticide applications. EPA
modeled the mean and maximum residues of propiconazole in various food items immediately after
application of propiconazole to representative crops. EPA used the maximum EECs and standard
food consumption values to estimate dietary exposure levels for birds and mammals. EECs were
determined for the following food categories: short grass, tall grass, broadleaf forage/small
insects, and fruit, pods, seeds/large insects. The EEC values on these food items may be found in
the June 30, 2006 document, Environmental Fate and Effects Division Revised RED for the
Reregistration of Propiconazole.
As mentioned above, EPA used a default 35-day foliar dissipation half-life to derive EECs.
EPA has limited chemical-specific data for foliar dissipation in wheat, from field trials for
propiconazole. These data were used as a surrogate for all potential vegetative feed forms for birds
and mammals. However, there are key uncertainties in these data. In the propiconazole field trials
for wheat, only a few samples were taken at the time of propiconazole application allowing residue
dissipation could be determined over time. Further, these field trials did not record local weather
data, which can affect dissipation. EPA took the 95th percentile upper confidence limit on the mean
foliar dissipation half-life to derive a 14.4 day foliar dissipation half-life. This value was used to
give a lower range for EECs for certain crops. The Agency is requiring a confirmatory foliar
dissipation study as part of this RED. This study would measure dissipation of propiconazole over
time from foliage of several representative crop groups.
Toxicity to Birds and Mammals. EPA determines the potential effects a pesticide can
40
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produce in a terrestrial organism by reviewing guideline toxicity studies that describe acute and
chronic effects of the chemical on birds and mammals. Table 15 summarizes the toxicity effects
and reference values used to assess potential risks to mammals and birds from unintentional
exposure to propiconazole. These toxicity values were used to calculate RQs based both on the
dose (in terms of mg/kg/body weight given in a gavage study) and diet (in terms of mg/kg of food
consumed). Dose-based RQs assumes that the uptake and absorption of a compound from a dose
given by oral gavage is similar to the dose the organism receives in the field from eating food items
containing residues of the compound. However, a gavage dose represents a short-term high-
intensity exposure, which is likely to be different from a typical dose level and duration in the field.
Dietary-based RQs assume that the dose of a compound administered in a laboratory feeding study
is similar to the level of residues the organism consumes in the field. However, the diet in a
laboratory feeding study differs significantly from the diet of an animal foraging in for food the
field.
Tabic 15. Toxicity Reference Values for Mammals and Birds for Propiconazole.
Exposure
Scenario
Species
Toxicity Reference Value
Toxicity Category or Effect
Mammals
Acute
Mouse
LD50= 729 mg ai/kg bwt
Category III
Chronic
Rat
NOAEL = 43 mg/kg bwt
Reduced body weight gain, liver changes in F0
generation, decreased offspring survival & body weight,
hepatic lesions
Birds
Acute
Bobwhite
quail
LD50 = 2825 mg ai/kg bwt
Practically non-toxic
Chronic
NOAEC = 1000 mg/kg diet
No treatment-related effects
LD50 - Median Lethal Dose or Concentration, statistically derived single dose or concentration that can be expected to
cause death in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation). NOAEL -
no observed adverse effect level, dose of compound in mg ai/kgbody weight/day; NOAEC - lowest observed adverse
effect concentration or concentration of compound in food associated with adverse effects, dose in mg ai/kg food
consumed.
Acute mammalian RQs for herbivores/insectivores were calculated on the basis of dose
(mg/kg body weight/day by gavage). Acute dose-based RQs assuming a default 35 day half-life are
below the LOC for all propiconazole uses except RQs for turf (Table 16a). The RQs for turf
exceeded the listed species LOC for mammals in all food categories except for fruits/pods/large
insects and grain (represented by the lower end of range of RQs presented). However, RQs based
on multiple applications of propiconazole to turf exceeded the acute LOC of 0.5 only for 15 g and
35 g smaller mammals in the short grass food category. Remaining RQs did not exceed any levels
of concern.
41
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Tabic 16a. Acute RQs for Terrestrial Mammals Exposed to Propiconazole (35 day half-life).*
Exposure Scenario (Crop)
Ranges of Acute RQs**
bv Bodv Weight
15 g
'Jl
CTQ
1000 g
Barley, Rye, Triticale
0.0003 - 0.02
0.00017-0.01
0.000036-0.003
Wheat
0.00-0.024
0.00-0.017
0.00-0.0038
Pecan, Grasses grown for seed
0.00-0.09
0.00-0.08
0.00-0.04
Corn, Celery
0.00-0.08
0.00-0.053
0.00-0.012
Peanut
0.00-0.06
0.00-0.05
0.00-0.03
Rice, Wild Rice
0.00-0.04
0.00-0.04
0.00-0.02
Stone Fruits
0.00-0.07
0.00-0.06
0.00-0.03
Turf and Ornamentals, ground cover
0.01-0.77
0.01-0.66
0.00-0.35
Turf and Ornamentals, lawns, turf, golf courses
0.01-0.7
0.01-0.6
0.00-0.32
Turf and Ornamentals, sod farm
0.01-0.61
0.01-0.52
0.00-0.28
* Acute RQs are based on an EPA default 35 foliar dissipation half-life. **Ranges of acute RQs are based on a variety
of food items, including short grass; tall grass; broadleaf plants and small insects; and fruits, pods, seeds, and large
insects. RQs in bold are above EPA's level of concern (LOC).
For crops where RQs exceeded the Agency's LOC (Table 16a), EPA revised the dose-
based RQs by using the limited chemical-specific data on foliar dissipation half-life previously
described. EPA ran the T-REX model using a 14.4 day foliar dissipation half-life derived from
propiconazole specific data, rather than the default foliar dissipation half-life of 35 days used in the
original screening-level assessment. Revised RQs are presented in Table 16b below and show no
acute risks of concern for mammals except for the smallest mammals feeding on short grass. In
addition, there are no listed species risks of concern for all weight classes of mammals feeding on
fruits, pods, seeds/large insects. However, the listed species LOC of 0.1 is exceeded for all weight
classes of mammals feeding on short grass, tall grass, and broadleaf plants and small insects.
Table 16b. Revised Acute RQs for Terrestrial Mammals Exposed to Propiconazole (14.4 day half-life).*
Exposure Scenario (Crop)
Ranges of Acute RQs**
by Body Weight
15 g
35 g
1000 g
Turf and Ornamentals, ground cover
0.01-0.57
0.01-0.49
0.00-0.26
Turf and Ornamentals, lawns, turf, golf courses
0.01-0.48
0.01-0.41
0.00-0.22
Turf and Ornamentals, sod farm
0.01-0.39
0.00-0.34
0.00-0.18
*Based on chemical-specific 14.4 day foliar dissipation half-life. **Represent variety of food items, including short
grass; tall grass; broadleaf plants and small insects; and fruits, pods, seeds, and large insects RQs in bold > LOC.
42
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Chronic risks to mammals based on the default 35-day half-life were calculated using both
the dietary- and dose-based RQs. Dietary-based RQs, not presented in the table below, only
exceeded the chronic LOCs for multiple applications to turf and ranged from 1.1 to 2.6. However,
dose-based chronic RQs (Table 17a) were as high as 13 for mammals foraging in short grass when
EPA assumed multiple applications of propiconazole to the crops listed below. Chronic RQs only
begin to exceed LOCs after the 3rd application and no chronic LOCs are exceeded after 2
applications. Acute risks would also be lower based on fewer applications. All other exposure
scenarios resulted in RQs below the Agency's LOC and are therefore not presented in Table 17a.
Tabic 17a. Chronic Dosc-Bascd RQs for Terrestrial Mammals Exposed to Propiconazole (35 day half-life)*
Exposure Scenario (Crop)
Ranges of Chronic RQs
by Body Weight
¦k-k
15 g
35 g
1000 g
Pecan, Grasses grown for seed
0.02 -1.51
0.02 -1.29
0.0-0.69
Stone Fruits
0.02 -1.13
0.01-0.96
0.01-0.52
Turf and Ornamentals, ground cover
0.18-13
0.16-11
0.08-6
*Based on an EPA default 35 foliar dissipation half-life. **Represent a variety of food items, including short grass;
tall grass; broadleafplants and small insects; and fruits, pods, seeds, and large insects. RQs in bold are above EPA's
level of concern (LOC).
When the Agency revised the chronic dose-based RQs using chemical-specific foliar
dissipation half-life data, almost all pecan, stone fruit, and grasses grown for seed chronic RQs do
not exceed the Agency's chronic LOC of 1 except for the smallest weight class of mammal feeding
on short grass in pecans (the RQ only barely exceeds at 1.04). For turf, chronic RQs do not exceed
the Agency's chronic LOC for all weight classes of mammals feeding on fruits, pods, large insects/
seeds; however, turf RQs exceed the Agency's chronic LOC for mammals feeding on short and tall
grass, and broadleaf plants and small insects.
Table 17b. Revised Chronic Dosc-Bascd RQs for Terrestrial Mammals Exposed to Propiconazole
(14.4 day half-life) *
Exposure Scenario (Crop)
Ranges of Chronic RQs**
bv Bodv Weight
15 g
35 g
1000 g
Pecan, Grasses grown for seed
0.01-1.04
0.01-0.89
0.01-0.47
Stone Fruits
0.00-0.89
0.01-0.76
0.01-0.41
Turf and Ornamentals, ground cover
0.13-9.64
0.11-8.23
0.06-4.41
*Based on a chemical-specific 14.4 day foliar dissipation half-life. **Represent a variety of food items, including short
grass; tall grass; broadleaf plants and small insects; and fruits, pods, seeds, and large insects. RQs in bold are above
EPA's level of concern (LOC).
Avian acute RQs based on the default 35-day foliar dissipation half-life do not exceed the
Agency's LOC of 0.5 except RQs for the smallest weight class of birds feeding on short grass
43
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derived from maximum residues from multiple applications to turf and ornamental uses (see bolded
numbers in Table 18a). When these RQs were revised using chemical-specific foliar dissipation
half-life data, only the RQ of 0.53 for smallest weight class of bird feeding on short grass exceeds
the LOC of 0.5 (Table 18b). However, RQs based on predicted maximum residues and multiple
applications to turf and ornamentals exceed the listed species LOC of 0.1 for all weight classes of
birds feeding on short grass and tall grass and for smaller birds feeding on broadleaf forage and
small insects based. For RQs based on predicted, mean residues resulting from multiple
applications to turf and ornamentals, only birds feeding on short grass exceed the endangered
species LOC. No other exposure scenarios result in RQs that exceed the Agency's LOCs. Acute
RQs are summarized in Tables 18a and b below; ranges are based on a variety of food items, weight
classes of birds, and number of applications.
Dietary-based avian chronic RQs presented in Table 18a show that the chronic LOC is
slightly exceeded for use of propiconazole on turf. However, chronic data for birds showed no
treatment-related effects at any of the test levels up to 1000 mg/kg diet and, as such, a LOAEC
could not be determined. Consequently, the actual NOAEC could be much greater than that
observed in the study used to assess chronic avian risk and the RQs could be lower. Dietary-based
chronic avian RQs only exceeded the LOC for multiple applications to turf and the highest RQ was
1.3 (Chronic LOC is 1). In addition, these RQs have been further refined by using chemical-
specific foliar dissipation half-life data resulting in a maximum RQ of only 1.02 (Table 18a). Based
on the lack of observed effects in the chronic study, and the fact that RQs based on this study only
slightly exceed the LOC, the Agency does not consider there to be chronic avian risks of concern
for propiconazole.
Tabic 18a. Acute and Chronic RQs for Birds Exposed to Propiconazole (35 day half-life).*
Exposure Scenario
(Crop)
Ranges of Acute RQs**
Ranges of Chronic RQs**
Based on
Maximum
Residues
Based on Mean
Residues
Based on Single
Application
Based on Multiple
Applications
Barley, Rye, Triticale
0.00-0.02
0.00-0.01
0.0016-0.027
NA
Wheat
0.00-0.02
0.00-0.00
0.0021 - 0.034
0.0011-0.02
Pecan, Grasses grown for
seed
0.00-0.08
0.00-0.03
0.0034 - 0.054
0.009-0.149
Corn, Celery
0.00-0.03
0.00-0.01
0.0-0.03
0.0-0.05
Peanut
0.00-0.06
0.00-0.02
0.00-0.05
0.01-0.1
Rice, Wild Rice
0.00-0.1
0.00-0.03
0.0034 - 0.054
0.004-0.08
Stone Fruits
0.00-0.061
0.00-0.02
0.0017-0.027
0.007-0.112
Turf and Ornamentals,
ground cover
0.00-0.70
0.00-0.25
0.027-0.427
0.08 -1.3
Turf and Ornamentals,
lawns, turf, golf courses
0.00-0.63
0.00-0.22
0.027-0.427
0.074 -1.18
44
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Tabic 18a. Acute and Chronic RQs for Birds Exposed to Propiconazole (35 day half-life).
¦k
Exposure Scenario
(Crop)
Ranges of Acute RQs**
Ranges of Chronic RQs**
Based on
Maximum
Residues
Based on Mean
Residues
Based on Single
Application
Based on Multiple
Applications
Turf and Ornamentals, sod
farm
0.00-0.54
0.00-0.19
0.027-0.427
0.06 -1.02
* Based on an EPA default 35 foliar dissipation half-life. **Represent a variety of food items, including short grass; tall
grass; broadleaf plants and small insects; and fruits, pods, seeds, and large insects. RQs are also based on different
weight classes of birds and single and multiple applications. RQs in bold are above EPA's level of concern (LOC).
Table 18b. Revised Acute and Chronic RQs for Birds Exposed to Propiconazole (14.4 day half-life).*
Exposure Scenario (Crop)
Ranges of Acute RQs
(based on multiple applications)
Ranges of Chronic RQs
(based on multiple applications)
Turf and Ornamentals, ground cover
0.00-0.53
0.06-0.96
Turf and Ornamentals, lawns, turf,
golf courses
0.00-0.45
0.05-0.81
Turf and Ornamentals, sod farm
0.00-0.37
0.04-0.66
*Based on a chemical-specific 14.4 day foliar dissipation half-life. ** Represent a variety of food items, including
short grass; tall grass; broadleafplants and small insects; and fruits, pods, seeds, and large insects. RQs are also based
on different weight classess of birds and single and multiple applications. RQs in bold are above EPA's level of
concern (LOC).
Non-Target Insects & Other Terrestrial Organisms. EPA currently does not estimate RQs
for terrestrial non-target insects. In addition, there were no data on non-target terrestrial insects,
such as honeybees. Propiconazole does not appear to have any adverse effects on soil microbes as
evidenced by soil biochemical analysis. Also, propiconazole showed no toxicity to earthworms.
Non-Target Terrestrial Plants. Terrestrial plants inhabiting dry and semi-aquatic (wetland)
areas may be exposed to pesticides from runoff and/or spray drift. Therefore, EPA estimated
exposure to terrestrial plants using the Terr-PLANT model based on the maximum label application
rate, a default amount of runoff based on solubility, and default assumptions regarding drift. EECs
for non-target plants resulting from a single application of propiconazole are presented in Table 19.
45
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Tabic 19. Propiconazole EECs derived from the Terr-PLANT screening model (and based on a single
application)
Crop
Application Rate
(lbs ai/A)
Application
Method
Total loading
to adjacent
areas (lb ai/A)
Total loading
to semi-aquatic
areas (lb ai/A)
Drift EEC
(lb ai/A)
Stone fruit
0.1125
Ground spray
0.0034
0.0236
0.0011
Aerial spray
0.0079
0.0281
0.0056
Wheat
0.08
Ground spray
0.0024
0.0168
0.008
Aerial spray
0.0056
0.020
0.004
Grasses grown for
seed, forage, fodder
grasses
0.225
Ground spray
0.0068
0.0473
0.0023
Aerial spray
0.0158
0.0563
0.0113
Turf and
ornamentals -
ground cover
1.78
Ground spray
0.0534
0.3738
0.178
Chemigation
0.12446
0.4450
0.089
EPA determines the potential effects a pesticide can produce in nontarget plants by
reviewing guideline toxicity studies that describe acute effects toxicity information for various
terrestrial plants. Tier 2 terrestrial plant data are available to show effect of technical propiconazole
on both seedling emergence and vegetative vigor. The seedling emergence study considered
percent emergence, plant height, and plant dry weight to determine the EC25 and NOAEC for each
of the species tested at use rates of 0.0185, 0.056, 0.167, 0.5, and 1.5 lb ai/A. The monocots tested
included onion, corn, oats, and ryegrass. Although the dicot species included carrot, soybean,
lettuce, cucumber, tomato, and cabbage, only cabbage showed a dose response sufficient to derive
an EC25. The other dicot species appeared to be unaffected by the treatments. Therefore, for the
purposes of risk assessment, the EC25 is assumed to be >1.5 lb ai/A for all of these species except
cabbage. The EC25 for cabbage is 0.18 lb ai/A, and the NOAEC is 0.056 lb ai/A based on plant dry
weight. The vegetative vigor study was performed using the same species and application rates as
the seedling emergence studies. Plant height and plant dry weight were the parameters measured to
determine a dose-response. Ryegrass was determined to be the most sensitive monocot based on
plant height, with an EC25 of 0.315 lb ai/A and a NOAEC of 0.0185 lb ai/A. As with the seedling
emergence study, cabbage was the most sensitive dicot based on plant dry weight, with an EC25 of
0.039 lb ai/A and a NOAEC of 0.056 lb ai/A. These data are summarized in Table 20 below.
Table 20. Acute Toxicity of Propiconazole to Terrestrial Plants
Species
EC25
(lb ai/A)
NOAEC/EC05
(lb ai/A)
Effect
Monocot
Onion, corn, oat, rygrass
>1.5
1.5
Seedling emergence: emergence, shoot
length, dry weight
Ryegrass
0.315
0.0185
Vegetative vigor: plant height
46
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Tabic 20. Acute Toxicity of Propiconazole to Terrestrial Plants
Species
ec25
(lb ai/A)
NOAEC/EC05
(lb ai/A)
Effect
Dicot
Cabbage
0.18
0.056
Seedling emergence: plant dry weight
0.039
0.056
Vegetative vigor: plant dry weight
EC25 - 25% Effect Concentration, statistically derived single dose or concentration that can be expected to cause effects
in 25% of the test organisms; EC 05 - 5% Effect Concentration, statistically derived single dose or concentration that can
be expected to cause effects in 5% of the test organisms; NOAEC - No adverse effects concentration.
Although propiconazole is a fungicide, it poses a potential risk to terrestrial plants for some
uses. The Agency calculated RQs for seedling emergence effects (using total exposure from drift
and runoff) and RQs for vegetative vigor for exposure via spray drift. RQs for nonlisted and listed
plant species are presented in Table 21 below. This screening-level risk assessment for nontarget
terrestrial plants suggests potential adverse effects on seedling emergence from runoff and spray
drift to adjacent fields and potential risk of adverse effects on vegetative vigor from spray drift
alone. RQs are below the LOC except for nonlisted dicots based on use on turf and listed dicots
based on use in grasses grown for seed, rice, wild rice, peanut, and turf use. The RQs for terrestrial
dicots (2.1-2.5) exceed the acute LOC of 1.0 for terrestrial plants in semi-aquatic areas at the
maximum application rate for turf. The RQs for listed terrestrial dicots in semi-aquatic areas is
greater than the LOC for use on turf and ornamentals and equal to the LOC for use on grass grown
for seed, rice, wild rice, peanut, and turf use. For monocots, RQs for listed species exceed the LOC
for spray drift from propiconazole use on turf and ornamentals.
Table 21. Acute Risk Quotients for Terrestrial and Semi-Aquatic Plants Exposed to Propiconazole
Scenario
RQs for Nonlisted Species*
RQs for Listed Species**
. ou.... Application
adjacent to treated
sites
in semi-
aquatic areas
adjacent to
treated sites
in semi-
aquatic areas
Method
Total
Exposure
Drift
Total
Drift
Total
Drift
Total
Drift
Nontarget Dicots
Grasses grown for
seed, Rice, Wild rice,
Peanut
Aerial
0.09
0.30
<0/31
0.30
0.04
0.20
1.01
0.20
Ground
0.04
0.06
0.26
0.06
0.12
0.04
0.84
0.04
Turf and ornamentals -
ground cover
Ground
0.03
0.46
2.1
0.46
0.95
0.32
6.68
0.32
Chemigation
0.7
2.28
2.47
2.28
2.23
1.59
7.95
1.59
Nontarget Monocots
Grasses grown for
seed, Rice, Wild rice,
Peanut
Aerial
<0.01
0.036
<0.06
<0.04
0.01
0.61
0.04
0.61
Ground
<0.005
0.007
<0.03
0.007
0.005
0.12
0.03
0.12
Turf and ornamentals -
ground cover
Ground
<0.04
0.06
<0.25
0.06
0.036
0.96
0.25
0.96
Chemigation
<0.08
0.28
<0.3
0.28
0.083
4.81
0.30
4.81
* RQs for nonlisted species are based on EC25; ** RQs for listed species based on NOAEC or EC05. Total exposure
includes runoff and drift; drift is from spray drift alone. RQs for total exposure based on seedling emergence endpoint;
RQs for spray drift are based on vegetative vigor endpoint.
47
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EPA's screening-level model Terr-PLANT assumes that a certain default fraction of total
pesticide applied will be transported to adjacent fields via surface runoff and spray drift. For
propiconazole, Terr-PLANT assumes that a default value of 2% propiconazole applied is available
to nontarget plants in adjacent fields. Terr-PLANT calculates exposure based only on a single
application, whereas propiconazole labels allow for multiple applications of propiconazole (i.e., as
many as 5 applications to stone fruit). Therefore, Terr-PLANT may potentially underestimate
exposure and risk to plants. However, the effects of multiple applications would only be additive if
the affected plants could not recover from the effects of successive applications. Furthermore, there
is uncertainty in the likelihood of co-exposure of spray drift and runoff, particularly after
subsequent applications.
To address uncertainties in the Terr-PLANT model and further characterize the risk to
nontarget terrestrial plants from runoff, EPA compared the EEC of 0.37 lb ai/A from a single
application of 1.78 lb ai/A of propiconazole to turf, with peak runoff EECs simulated by PRIZM
over 30 years. The transport of propiconazole from the peak runoff event for each of 30 years
simulated by PRZM ranged from 0.009 lb ai/A to 0.245 lb ai/A. These EECs, which reflect 4
applications of propiconazole at 1.78 lb ai/A, would result in acute RQs ranging from 0.05 to 1.4 if
used in the risk assessment. Peak storm events simulated by PRZM would result in RQs at or
above the LOC of 1.0 in 6 of the 30 years simulated, indicating a potential risk to plants adjacent to
treated fields under certain conditions if the maximum rate and number of applications are applied.
Additional details of this assessment may be found in the July 18, 2006 document, Terrestrial Plant
Runoff Risk Assessment for Propiconazole on Turf Using PRZM. Use data indicate that typical
rates in the states with the greatest use range from 0.7 to 1.2 lbs ai/A. Since these typical rates are at
least 1/3 less than the maximum rate, the 25% effect on seedling emergence represented by the
toxicity endpoint might occur even less frequently than suggested by the PRZM model output.
EPA also used the AG-DRIFT model, which simulates spray drift at various distances from
the site of application, to further characterize exposure and risk to nontarget terrestrial plants.
Pesticide application was simulated using low-boom ground spray equipment to turf, using nozzles
which produce a very fine to fine droplet size spectrum. Using the 90th percentile drift data
generated by the Spray Drift Task Force on which AgDrift is based, the model predicted the
distances to which point exposure would be equivalent to the EC25 values for various crops tested
in the propiconazole vegetative vigor studies. As shown in Table 22 below, an AgDRIFT
simulation for the four most sensitive plants in a vegetative vigor study showed that spray drift RQs
from ground application of propiconazole to turf would exceed the LOC to distances of 3 ft, 7 ft, 13
ft and 43 ft, assuming 10 mph wind perpendicular to the spray path.
Tabic 22. Distance Where Spray Drift Deposition Equals EC2? Following Spray Application to Turf
Distance of Spray
Drift Deposition with
Ag-DRIFT following
application of 1.78 lb
ai/A to Turf
Vegetative Vigor EC2s for Sensitive Test Crops
Corn
0.968 lb ai/A
Onion
0.334 lb ai/A
Soybean
0.16 lb ai/A
Cabbage
0.039 lb ai/A
3.3 ft
6.6 ft
13.1ft
42.7 ft
The results indicate that exposure that would result in risk quotients at the acute LOC would
be expected to occur within 50 feet of turf treated with propiconazole. An additional calculation was
48
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done to determine the distance at which point deposition would be equivalent to the lowest NOAEC
in the vegetative vigor test (0.0185 lb ai/A for ryegrass). The calculated distance of 91.86 feet
suggests that listed plants more than 100 feet of a treated field may be at less risk.
The next highest application rate for propiconazole after turf is 0.225 lb ai/acre for grasses
grown for seed, pecan, and rice, which is lower than the EC25 for all but soybeans and cabbage in
the vegetative vigor test. However, drift from aerial application of 0.225 lb ai/acre could result in
point deposition equal to the cabbage vegetative vigor EC25 of 0.039 lb ai/A up to a distance of 49
feet, assuming a default fine to medium droplet size spectrum. Drift from aerial application of 0.225
lb ai/acre could result in point deposition equal to the ryegrass vegetative vigor NOAEC of 0.0185
lb ai/A up to a distance of 118 feet, assuming the same fine to medium droplet size spectrum.
b. Aquatic Organisms
Freshwater and Estuarine/Marine Fish and Invertebrates. To assess potential risks to
aquatic animals, the Agency considers predicted estimated environmental concentrations (EECs) in
surface water using the Tier II model PRZM/EXAMS. Unlike the drinking water assessment
described in the human health risk assessment section of this document, the exposure values used in
the ecological risk assessment consider pesticide transport as a result of runoff, erosion, off-target
spray drift, and environmental fate of pesticides in surface water but do not include the Index
Reservoir (IR) and Percent Cropped Area (PCA) factor refinements. These factors represent a
drinking water reservoir, not the variety of aquatic habitats relevant to a risk assessment for aquatic
animals, such as ponds adjacent to treated fields. Therefore, the EEC values used to assess
exposure and risk to aquatic animals are not the same as those used to assess exposure and risk to
humans from pesticides in drinking water.
The EECs of propiconazole used in the ecological risk assessment are summarized in Table
23 below. The highest EEC is 86.5 and is associated with the use of propiconazole on rice. The
rice scenario represents the most conservative aquatic exposure estimate of the potential
exposure scenarios for propiconazole; the rice EEC value of 86.5 ppb represents paddy
discharge water with consideration of adsorption, degradation, and dilution but does not
account for degradation after discharge. The turf scenario represents the next highest EECs; this
scenario assumes use at the maximum rate, maximum number of applications, and minimum time
interval between applications.
Tabic 23. Estimated Environmental Concentrations of Propiconazole in Surface Water
Use
Scenario and State
Peak
(HS/L)
96-hour
average
(Hg/L)
21-day
average
(Hg/L)
60-day
average
(Hg/L)
90-dav
average
(Hg/L)
Wheat ND
3.70
3.64
3.41
3.12
3.08
Grass Seed OR
5.69
5.63
5.41
5.06
4.95
Rice
86.5
71.1
34.2
17.8
11.9
Pecans GA
12.15
11.93
11.21
10.15
9.49
49
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Tabic 23. Estimated Environmental Concentrations of Propiconazole in Surface Water
Use
Scenario and State
Peak
(HS/L)
96-hour
average
(Ug/L)
21-day
average
(Ug/L)
60-day
average
(Ug/L)
90-dav
average
(Ug/L)
Peaches GA
3.35
3.28
3.01
2.55
2.35
Sweet Corn FL
13.28
13.00
12.32
10.70
9.77
Sweet Corn OR
4.49
4.46
4.30
4.09
4.06
Dry Beans MI
6.49
6.41
6.17
5.83
5.64
Peanuts NC
7.00
6.89
6.49
6.16
5.75
Barley (based on ND
Wheat)
1.92
1.89
1.79
1.66
1.61
Celery (based on FL
Carrots)
9.83
9.68
9.12
7.07
5.97
Turf PA
40.35
39.59
37.28
34.83
33.98
Turf FL
34.77
34.09
31.14
27.93
27.04
EPA determines the potential effects a pesticide can produce in an aquatic organism by
reviewing guideline toxicity studies that describe acute and chronic effects for various aquatic
animals. Table 24 below summarizes the toxicity effects and reference values used to assess
risk of propiconazole to aquatic organisms. No acceptable guideline chronic toxicity studies
were available for propiconazole in estuarine/marine fish; however, the LC50 for spot was
2244 ug/L, compared with an LC50 of 850 ug/L for rainbow trout.
Table 24. Propiconazole Toxicity Reference Values for Aquatic Organisms.
Exposure Scenario
Species
Exposure
Duration
Toxicity
Reference Value
(ppb)
Toxicity
Category or
Effect
Freshwater Fish
Acute
rainbow trout
96 hours
LC50 = 850
Highly toxic
Chronic
Fathead minnow
Early life stage
NOAEC = 95
Mortality, length,
weight
Freshwater
Invertebrate
Acute
Daphnia magna
96 hours
LC50 = 4800
Slightly toxic
Chronic
Daphnia magna
Study not suitable for use in risk assessment
Estuarine/Marine
Fish
Acute
Spot
96 hours
LC50 = 2244
Moderately toxic
Chronic
No acceptable guideline studies were available
Estuarine/Marine
Invertebrates
Acute
Mysid shrimp
96 hours
LC50 = 510
Highly toxic
Chronic
Mysid shrimp
Life cycle
NOAEC = 205
Mortality and
number of
offspring
50
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Table 25 presents acute and chronic RQs for both estuarine/marine and freshwater fish
and invertebrates. Based on the maximum l-in-10 year peak surface water concentrations and
the most sensitive 96-hour LC50 values for fish and aquatic invertebrates, all propiconazole
RQs are less than the Agency's LOC for acute risk (0.5). However, the freshwater fish RQ is
equal to the acute listed species LOC of 0.05 based on EECs in surface water from turf use in
Pennsylvania, but does not exceed based on EECs in surface water from turf use in Florida. In
addition, the estuarine/marine fish acute RQ exceeds the listed species LOC based on rice use.
And finally, the estuarine/marine invertebrate acute RQs exceed the acute listed species LOC
(0.05) for both the turf and rice uses. No LOCs were exceeded for any other crop to which
propiconazole is applied; RQs for the other crops are significantly less than the turf RQ and
the LOC and therefore were not included in Table 25.
Chronic RQs that for freshwater fish and for estuarine/marine invertebrates do not
exceed the Agency's chronic LOC of 1 based on average surface water concentrations of
propiconazole resulting from both the turf and rice scenarios and available toxicity data.
These RQs are presented in Table 25 below. As previously mentioned, the Agency does not
have adequate chronic toxicity data to assess chronic risks from propiconazole uses to
estuarine/marine fish or freshwater invertebrates. There is a data gap for these studies;
however, the existing data may be upgraded.
Tabic 25. Summary of Acute and Chronic Risk Quotients for Aquatic Organisms Exposed to Propiconazole.
Crop
Freshwater RQs
Estuarinc/IVIarinc RQs
EECs (ppb)
Scenario
Fish
Invertebrates
Fish
Invertebrates
Acute Risks
Turf
40.35 (peak)
0.05
0.008
0.02
0.08
Rice
86.5
0.1
0.02
0.04
0.17
Chronic Risks
Turf
34.8 (fish - 60 day average)
37.3 (invertebrate - 21 day average)
0.36
No data
No data
0.18
Rice
17.81 (fish - 60 day average)
34.24 (invertebrates - 60 day average)
0.19
No data
No data
0.17
Aquatic Plants. EPA determines the potential effects a pesticide can produce in
aquatic plants by reviewing guideline toxicity studies that describe acute and chronic effects
for various aquatic plants. Table 25 summarizes the toxicity data used to assess risk of
propiconazole to aquatic plants. These studies showed that the marine diatom, Skeletonema
costatum, is the most senstive aquatic plants species of those tested with a NOAEC of 18 ug/L.
The NOAEC is used to calculate acute listed species RQs and the EC50 is used to calculate
acute RQs for aquatic plants.
51
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Tabic 26. Acute Toxicity of Propiconazole to Aquatic Plants
Species
ECa,
(us ai/L)
NOA.EC/ECos
(uj? ai/L)
Effect
Vascular Plants
Duckweed (Lemna gibba)
4828
<2540
Frond count
Non-Vascular Plants
Freshwater diatom {Navicula pelliculosa)
93
51
Dry cell weight
Blue green algae (Skeletonema costatum)
21
<18
Dry cell weight
As shown in Table 27 below, the use of propiconazole on rice and turf may present risk
to non-vascular estuarine/marine plants; both the acute and listed species RQs exceed the LOC
of 1. In addition, the use of propiconazole on rice may present an acute risk to listed
freshwater non-vascular plants; the listed species RQs exceed the LOC of 1.
The RQs for freshwater vascular plants based on both turf and rice use and the RQs for
freshwater non-vascular plants based on turf use do not exceed the LOC. In addition, RQs
based on EECs for other crops do not exceed the Agency's LOC and are therefore not
presented in Table 27 below. As previously mentioned, the highest modeled EECs are for the
use of propiconazole on rice.
Table 27. Risk Quotients for Aquatic Plants Exposed to Propiconazole.
Crop
EECs
Freshwater Vascular
Plants
Freshwater Non-
Vascular Plants
Estuarinc/Marine
Non-Vascular Plants
(ppb)
Listed
Acute
Listed
Acute
Listed
Acute
Turf - Florida
34.88
Not calculated, less than PA turf and not of
concern
>1.93
1.66
Turf-
Pennsylvania
40.35
>0.016
0.008
0.79
0.43
>2.24
1.92
Rice
86.5
>0.03
0.02
1.7
0.93
>4.81
4.12
RQs in bold are above EPA's level of concern (LOC).
3. Endangered Species
The screening-level risk assessment for propiconazole indicates a potential for adverse
effects on listed species as noted below, should exposure actually occur at modeled levels:
Terrestrial organisms
• Mammals
o Acute RQs for turf and ornamentals exceed LOCs for small mammals
feeding on short grass, tall grass, broadleaf forage and small insects;
52
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o Chronic RQs for turf and ornamentals exceed LOC for all mammals
feeding on short grass, tall grass, broadleaf forage and small insects;
• Birds
o Acute RQs for turf and ornamentals exceed LOCs for all birds feeding
on short grass and tall grass and for smaller birds feeding on broadleaf
forage and small insects;
o Chronic RQs for turf and ornamentals barely exceed the LOC.
Although these RQs were based on a study that showed no effects at the
highest dose tested; EPA cannot preclude potential adverse effects to
listed species;
• Plants
o Acute RQs for turf and ornamentals exceed LOCs for listed terrestrial
plants (monocots and dicots) adjacent to treated sites and in semi-
aquatic areas;
o Acute RQs for grasses grown for seed, rice, and peanuts are equal to the
LOC for dicots in semi-aquatic areas.
Aquatic Organisms
• Freshwater
o Acute fish RQ for Pennsylvania turf is equal to LOC for listed species;
Florida turf scenario does not exceed LOC;
o Acute fish RQ for rice exceeds LOC for listed species;
o Because no data are available to evaluate chronic risks to freshwater
invertebrates, EPA has a potential concern for listed species;
• Estuarine/Marine
o Acute invertebrate RQs for turf and rice exceed LOC for listed species;
o Because no data are available to evaluate chronic risks to
estuarine/marine fish, EPA has a potential concern for listed species;
• Plants
o Acute RQs for turf exceed LOCs for listed estuarine/marine nonvascular
plants; and
o Acute RQs for rice exceed LOCs for listed freshwater and
estuarine/marine nonvascular plants.
These conclusions are based solely on EPA's screening-level assessment and do not
constitute "may effect" findings under the Endangered Species Act for any listed species.
4. Ecological Incidents
EPA completed a review of the Ecological Incident Information System (EIIS)
database for ecological incidents involving propiconazole in November 2005. This database
reported a total of six incidents associated with the use of propiconazole: four involving
damage to terrestrial plants, and the remaining two involving damage to fish and shrimp.
However, because no environmental sampling was conducted to evaluate pesticide residues,
there is considerable uncertainty about the credibility of these incidents. Therefore, all of the
propiconazole incidents were classified as having a "possible" rather than a "probable" or
53
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"highly probable: association with propiconazole. No detailed information was available for
the terrestrial plant incidents; therefore, the extent of damage and recovery is not known.
IV. Risk Management, Reregistration, and Tolerance Reassessment
A. Determination of Reregistration Eligibility
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 propiconazole 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 propiconazole.
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
propiconazole. Based on a review of these data and on public comments on the Agency's
assessments for the active ingredient propiconazole, 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 the active ingredient
propiconazole are eligible for reregistration provided that: (i) required product-specific data
are submitted, (ii) the risk mitigation measures outlined in this document are adopted, and (ii)
label amendments are made to reflect these measures. Necessary label changes are described
in Section V. Appendix A summarizes the uses of propiconazole 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 propiconazole, and lists the submitted
guideline studies that the Agency found acceptable. Data gaps are identified as generic data
requirements that have not been satisfied with acceptable data.
Based on its evaluation of propiconazole, the Agency has determined that
propiconazole 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 propiconazole. If all changes outlined in this
document are incorporated into the product labels, then all current risks for propiconazole will
be adequately mitigated for the purposes of this determination under FIFRA. Once an
Endangered Species assessment is completed, further changes to these registrations may be
necessary as explained in Section III.B.3. of this document.
B. Public Comments and Responses
Through the Agency's public participation process, EPA worked with stakeholders and
the public to reach the regulatory decisions for propiconazole. EPA released its preliminary
risk assessments for propiconazole for public comment on February 15, 2006, for a 60-day
public comment period (Phase 3 of the public participation process). During the public
54
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comment period on the risk assessments, which closed on April 17, 2006, the Agency received
comments from the American Mushroom Institute, the University of Georgia, the University
of Hawaii, the US Triazole Task Force, and the major technical registrants, Janssen
Pharmaceutica Inc. and Syngenta Crop Protection. These comments in their entirety,
responses to the comments, as well as the preliminary and revised risk assessments, are
available in the public docket (EPA-HQ-OPP-2005-0497) at the address given above and in
the EPA's electronic docket at http://www.regulations.gov.
C. Regulatory Position
1. Food Quality Protection Act Findings
a. "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
propiconazole are within acceptable levels. In other words, EPA has concluded that the
tolerances for propiconazole 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 propiconazole from all possible sources.
b. Determination of Safety to U.S. Population
The Agency has determined that the established tolerances for propiconazole, with
amendments and changes as specified in this document, 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
propiconazole. In reaching this conclusion, the Agency has considered all available
information on the toxicity, use practices and exposure scenarios, and the environmental
behavior of propiconazole and its free triazole degradates.
As discussed in Section III, the aggregate risks from propiconazole from food, drinking
water, and residential exposure are not of concern. Furthermore, aggregate risks from the free
triazoles (1,2,4-triazole, traizole 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 propiconazole, with
amendments and changes as specified in this document, 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
55
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due to the specific consumption patterns of infants and children, as well as the possibility of
increased susceptibility to the toxic effects of propiconazole residues in this population
subgroup.
In determining whether or not infants and children are particularly susceptible to toxic
effects from exposure to residues of propiconazole, the Agency considered the completeness
of the hazard database for developmental and reproductive effects, the nature of the effects
observed, and other information. On the basis of this information, the FQPA SF has been
removed (i.e., reduced to IX) for propiconazole. In addition, the Agency determined whether
infants and children show potential susceptibility from exposure to residues of the free triazole
degradates 1,2,4-triazole, triazole acetic acid, and triazole alanine. EPA retained a 10X FQPA
SF for 1,2,4-triazole based on nervous system effects and database uncertainties, including a
data gap for acute and developmental neurotoxicity studies. (A developmental neurotoxicity
study is required for 1,2,4-triazole.) The Agency also retained a 10X FQPA SF for the triazole
conjugates to address concerns for increased susceptibility seen in the available rat
developmental toxicity and two-generation reproduction and to address uncertainties associated
with an incomplete database. There are data gaps for rabbit developmental toxicity studies with
triazole alanine and triazole acetic acid, a chronic rat study with triazole alanine, and a combined
90-day/subchronic neurotoxicity rat study for triazole acetic acid. The rationale for the decisions
on the FQPA SF for both propiconazole and the free triazoles can be found in Section III and
in the documents, Propiconazole - 3X database uncertainty factor used in risk assessment,
dated December 29, 2005 and 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, dated February 7, 2006, both of which may be
found in the docket EPA-HQ-OPP-2005-0497.
2. Endocrine Disruptor Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a 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 that EPA 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). In the available toxicity studies on propiconazole, there was no evidence of
estrogen, androgen, and/or thyroid-mediated toxicity. Although the available toxicity data for
1,2,4-triazole indicate potential estrogen, androgen, and thyroid effects, the Agency believes
that the current risk assessment is protective of these effects. When additional appropriate
screening and/or testing protocols being considered by the Agency's EDSP have been
developed, propiconazole may be subjected to further screening and/or testing to better
56
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characterize effects related to endocrine disruption.
3. Cumulative Risks
Section 408(b)(2)(D)(v) of FIFRA 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 propiconazole does 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. Propiconazole 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.
D. Tolerance Reassessment Summary
1. Tolerance Definition
EPA has established tolerances for propiconazole in/on animal and plant commodities
under 40 CFR §180.434. These tolerances are currently expressed in terms of the combined
residues of propiconazole (l-[[2-(2,4-dichlorophenyl)-4-propyl-l,3-dioxolan-2-yl]methyl]-li7-
1,2,4-triazole) and its metabolites determined as residues converted to 2,4-dichlorobenzoic
acid (DCB A) and expressed as parent compound. As part of the tolerance reassessment for
propiconazole, the tolerance expression should be revised to parent propiconazole per sc\ (1-
[[2-(2,4-dichlorophenyl)-4propyl-1,3-dioxolan-2-yl]methyl]-\H-1,2,4-triazole). Because the
analytical method is a common moiety method detecting all residues (parent and metabolites)
that are converted to DCB A, the field trial studies reported total residues, and tolerance levels
based on these data may be overestimated. (Future field trial studies should use a method that
analyzes for both parent and metabolites.) Although the free triazoles are not included in
tolerance expression; they are considered in the risk assessment supporting tolerance
reassessment. A summary of the residues considered in the risk assessment and in the
tolerance expression for propiconazole is given in Table 28.
Tabic 28. Summary of Propiconazole Residues of Concern for Tolerance Expression and Risk Assessment
Matrix
For Risk Assessment1
For Tolerance
Expression
Propiconazole
Free Triazoles
Plants, rotational crops,
livestock
Parent plus all metabolites
convertible to 2,4-DCBA
1,2,4-triazole, triazole
alanine, triazole acetic acid
Parent only
Water
Parent only
1,2,4-triazole
Not applicable
57
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Tabic 28. Summary of Propiconazole Residues of Concern for Tolerance Expression and Risk Assessment
Matrix
For Risk Assessment1
For Tolerance
Expression
Propiconazole
Free Triazolcs
'Three risk assessments were conducted, one for propiconazole parent, one for 1,24,-triazole, and a combined
assessment for the triazole conjugates, triazole alanine and triazole acetic acid.
2. Tolerance Reassessment Summary
The reassessments of tolerances for some commodities are contingent upon the
implementation of requested label revision(s). The propiconazole tolerance reassessment is
summarized in Table 29.
Table 29. Tolerance Reassessment Summary for Propiconazole
Commodity
Current Tolerance,
ppm
Reassessed
Tolerance, ppm
Comment
[Correct Commodity Definition!
Tolerances Established Under 40 CFR § 180.434(a)
for Raw Agricultural Commodities (RACs)
Banana
0.2
0.2
[Banana]
Barley, grain
0.1
0.3
Available residue data for wheat support
raising barley tolerance.
Barley, straw
1.5
15.0
Available residue data for wheat support
raising the barley tolerance.
Cattle, fat
0.1
0.1
Maximum theoretical dietary burden
(MTDB) of 0.08 ppm supports
maintaining tolerance at current level.
Cattle, kidney
2.0
2.0
MTDB of 1.01 ppm supports
maintaining tolerance at current level.
Cattle, liver
2.0
2.0
MTDB of 1.33 ppm supports
maintaining tolerance at current level.
Cattle, meat byproducts,
except kidney and liver
0.1
0.1
MTDB of 0.08 ppm supports
maintaining tolerance at current level.
Cattle, meat
0.1
0.1
MTDB of 0.04 ppm supports
maintaining tolerance at current level.
Celery
5.0
5.0
Available residue data support
maintaining tolerance at current level.
Corn, field, grain
0.1
0.1
Tolerance expires on November 30,
2008.
Corn, field, stover
12
12
Tolerance expires on November 30,
2008.
Corn, field, forage
12
12
Tolerance expires on November 30,
2008.
58
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Tabic 29. Tolerance Reassessment Summary for Propicona/olc
Commodity
Current Tolerance,
ppm
Reassessed
Tolerance, ppm
Comment
[Correct Commodity Definition]
Corn, sweet, kernel plus
cob with husks removed
0.1
0.1
Tolerance expires on November 30,
2008.
Fruit, stone, group 12
1.0
1.0
Available residue data support
maintaining tolerance at current level.
Goat, fat
0.1
0.1
MTDB of 0.08 ppm supports
maintaining tolerance at current level.
Goat, kidney
2.0
2.0
MTDB of 1.01 ppm supports
maintaining tolerance at current level.
Goat, liver
2.0
2.0
MTDB of 1.33 ppm supports
maintaining tolerance at current level.
Goat, meat byproducts,
except kidney and liver
0.1
0.1
MTDB of 0.08 ppm supports
maintaining tolerance at current level.
Goat, meat
0.1
0.1
MTDB of 0.04 ppm supports
maintaining tolerance at current level.
Grass, forage
0.5
0.5
Available residue data support
maintaining tolerance at current level.
Grass, hay
40
40
Available residue data support
maintaining tolerance at current level.
Grass, straw
40
40
Available residue data support
maintaining tolerance at current level.
Hog, fat
0.1
0.1
MTDB of 0.08 ppm supports
maintaining tolerance at current level.
Hog, kidney
2.0
2.0
MTDB of 1.01 ppm supports
maintaining tolerance at current level.
Hog, liver
2.0
2.0
MTDB of 1.33 ppm supports
maintaining tolerance at current level.
Hog, meat byproducts,
except kidney and liver
0.1
0.1
MTDB of 0.08 ppm supports
maintaining tolerance at current level.
Hog, meat
0.1
0.1
MTDB of 0.04 ppm supports
maintaining tolerance at current level.
Horse, fat
0.1
0.1
MTDB of 0.08 ppm supports
maintaining tolerance at current level.
Horse, kidney
2.0
2.0
MTDB of 1.01 ppm supports
maintaining tolerance at current level.
Horse, liver
2.0
2.0
MTDB of 1.33 ppm supports
maintaining tolerance at current level.
Horse, meat byproducts,
except kidney and liver
0.1
0.1
MTDB of 0.08 ppm supports
maintaining tolerance at current level.
Horse, meat
0.1
0.1
MTDB of 0.04 ppm supports
maintaining tolerance at current level.
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Tabic 29. Tolerance Reassessment Summary for Propicona/olc
Commodity
Current Tolerance,
ppm
Reassessed
Tolerance, ppm
Comment
[Correct Commodity Definition]
Milk
0.05
0.05
MTDB of 0.03 ppm supports
maintaining tolerance at current level.
Mushroom
0.1
0.1
Pending approval of a label use on
mushrooms and submission of
directions for use (OPPTS 860.1200).
Use supported by IR-4.
Oat, forage
10.0
10.0
[Oat, forage]
Oat, grain
0.1
0.1
[Oat, grain]
Oat, hay
30.0
2.0
Available data for wheat support
lowering tolerance for oat hay.
Oat, straw
1.0
1.0
Available residue data support
maintaining tolerance at current level.
Peanut
0.2
0.2
Tolerance expires November 30, 2008.
Peanut, hay
20.0
20.0
Tolerance expires November 30, 2008.
Pecans
0.1
Reassign
Tolerance should be reassigned
concomitant with establishing a
tolerance of 0.1 ppm for Nut, tree,
Group 14
Pineapple
0.1
0.1
Tolerance expires November 30, 2008.
Pineapple processing study required.
Pineapple, fodder
0.1
Revoke
No longer considered a significant
livestock feed item, revoke. Tolerance
expires November 30, 2008.
Plum, prune, fresh
1.0
Revoke
Tolerance should be revoked because a
crop group tolerance has been
established for Fruit, stone, Group 12.
Rice, grain
0.1
0.3
Available residue data support raising
tolerance.
Rice, straw
3.0
3.0
Available residue data support
maintaining tolerance at current level.
Rye, grain
0.1
0.3
Available residue data support raising
tolerance.
Rye, straw
1.5
15.0
Available residue data for wheat straw
support raising the tolerance.
Sheep, fat
0.1
0.1
MTDB of 0.08 ppm supports
maintaining tolerance at current level.
Sheep, kidney
2.0
2.0
MTDB of 1.01 ppm supports
maintaining tolerance at current level.
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Tabic 29. Tolerance Reassessment Summary for Propiconazolc
Commodity
Current Tolerance,
ppm
Reassessed
Tolerance, ppm
Comment
[Correct Commodity Definition]
Sheep, liver
2.0
2.0
MTDB of 1.33 ppm supports
maintaining tolerance at current level.
Sheep, meat byproducts,
except kidney and liver
0.1
0.1
MTDB of 0.08 ppm supports
maintaining tolerance at current level
Sheep, meat
0.1
0.1
MTDB of 0.04 ppm supports
maintaining tolerance at current level.
Wheat, grain
0.1
0.30
Available residue data support raising
tolerance.
Wheat, straw
1.5
15.0
Available residue data support raising
tolerance.
Tolerances To Be Proposed Under 40 CFR § 180.434(a)
for Raw Agricultural Commodities
Grain, aspirated grain
fractions
20 (sorghum)
5.0
Available residue data support lowering
tolerance. Time-limited tolerance for
sorghum Section 18 registration expires
June 30, 2008.
Barley, hay
None established
2.0
Translate from wheat hay
Corn, pop, grain
None established
0.1
Translate from field corn
Corn, pop, stover
None established
12
Translate from field corn
Corn, sweet, forage
None established
12
Translate from field corn
Corn, sweet, stover
None established
12
Translate from field corn
Nut, tree, group 14
None established
0.1
[Nut, tree. Group 14]
Rice, bran
None established
1.0
Rice processing study shows 2.9x
concentration factor for rice bran.
Rice, hulls
None established
1.2
Rice processing study shows 3.8x
processing factor for rice hulls.
Rye, forage
None established
2.0
Available residue data support
tolerance.
Wheat, forage
None established
2.0
Available residue data support
tolerance.
Wheat, hay
None established
2.0
Available residue data support
tolerance.
Wheat, bran
None established
1.0
Available residue data support
tolerance.
Time-limited Tolerances Established Under 40 CFR § 180.434(b)
for FIFRA §18 Emergency Exemptions
Blueberry
1.0
N/A
Tolerance expires December 31, 2007.
Cranberry
1.0
N/A
Tolerance expires December 31, 2007.
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Tabic 29. Tolerance Reassessment Summary for Propicona/olc
Commodity
Current Tolerance,
|)|)m
Reassessed
Tolerance, ppm
Comment
[Correct Commodity Definition]
Dry bean
0.5
N/A
Tolerance expired December 31, 2005.
[Bean, dry]
Dry bean forage
8.0
N/A
Tolerance expired December 31, 2005.
[Bean, dry, forage]
Dry bean hay
8.0
N/A
Tolerance expired December 31, 2005.
[Bean, dry, hay]
Grain, aspirated grain
fractions
20 (sorghum)
5.0
Available residue data support lowering
tolerance. Tolerance expires June 30,
2008.
Sorghum, grain, grain
0.2
N/A
Tolerance expires June 30, 2008.
Sorghum, grain, stover
1.5
N/A
Tolerance expires June 30, 2008.
Soybean
2.0
N/A
Tolerance expires December 31, 2009.
Soybean, forage
10.0
27N/A
Tolerance expires December 31, 2009.
Soybean, hay
25.0
N/A
Tolerance expires December 31, 2009.
Tolerances Established Under 40 CFR § 180.434(c) for Regional Registrations
Sunflower
None established
TBD
To be determined pending submission
of field trial data.
Mint, tops (leaves and
stems)
0.3
0.3
Regional registration for use west of the
Cascade Mountains only. [Peppermint,
tops] [Spearmint, tops]
Wild rice
0.5
0.5
Regional registration for use only in
Minnesota. [Rice, wild]
a. Tolerances for Raw Agricultural Commodities (RACs)
Established Under 40 CFR §180.434(a)
The Agency has recently updated the list of raw agricultural and processed
commodities and feedstuffs derived from crops (Table 1, OPPTS GLN 860.1000). As a result
of these changes, tolerances must be established for raw agricultural commodities recently
added to the list in Table 1, OPPTS GLN 860.1000 and certain tolerances for crops in a crop
group should be reassigned. The established tolerance for plums should be revoked because a
stone fruit group tolerance has been established. The established tolerance for pineapple
fodder should be revoked because this commodity is no longer considered a significant
livestock feed item. The established tolerances for RACs listed under 40 CFR § 180.434(a) are
reassessed at the same levels except those listed for barley, rice, rye, and wheat; higher
tolerances are required for these crops to reflect the results of recent field trials. The
established tolerances for cattle, goat, hog, horse, and sheep commodities listed under 40 CFR
§ 180.434(a) are reassessed at the same levels as well, because EPA is unable to separate the
parent residues from the metabolites, and because the pending petitions for new uses are likely
to result in an increased dietary burden.
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b. Tolerances for RACs to be Proposed under 40 CFR
§180.434(a)
Because of changes to Table 1 in OPPTS GDLN 860.1000, new tolerances must be
proposed for barley hay, rye forage, and wheat forage and hay. The required data for wheat
hay and forage will be translated to barley hay and rye forage. Because the tolerance level for
oat hay was not determined from residue data but was calculated from the oat forage level
using a 3x dry-down factor, the required data for wheat hay should be translated to oat hay to
provide a more realistic level for this tolerance. Based on the cited field trials with Stratego™
Twin-Pak™ and Stratego™, the Agency proposes new tolerances on wheat hay and forage at
2.0 ppm. The Agency now recommends that wheat hay data be translated to oats to establish a
more appropriate level for the oat hay tolerance at 2.0 ppm.
The Agency is translating the wheat grain, wheat straw, wheat hay, and wheat forage
data to barley and rye grain, straw, hay and forage. Therefore, the reassessed tolerances for
barley grain and rye grain should be 0.3 ppm, for barley and rye straw should be 15.0 ppm.
New tolerances for barley hay and rye forage should be established at 2.0 ppm. Data from a
wheat processing study indicate the need for 1.0 ppm tolerance for wheat bran and a 5.0 ppm
tolerance for aspirated grain fractions. The available rice processing data indicate that residues
of propiconazole may concentrate in rice bran at 2.9x, in rice hulls at 3.8x, and in polished rice
at 0.12x. Based on a highest average field trial (HAFT) residue value of 0.28 ppm, new
tolerances of 1.0 and 1.2 ppm must be proposed for rice bran and hull, respectively.
The commodity definitions for the corn RAC tolerances are currently expressed as corn
per se. When the definition is revised to "corn, field" tolerances for popcorn grain and stover,
expressed in terms of "corn, pop," will need to be established at levels of 0.1 ppm and 12 ppm,
respectively. In addition, tolerances for "corn, sweet, forage" and "corn, sweet, stover" will
need to be established at 12 ppm. Processing data are required for pineapple juice.
c. Time-Limited Tolerances Established Under 40 CFR
§180.434(b)
Time-limited tolerances have been established for blueberry; cranberry; grain,
aspirated fractions; sorghum grain, grain; sorghum grain, stover; soybean; soybean forage; and
soybean hay to support FIFRA Section 18 registrations for these commodities. These time-
limited tolerances have expiration dates ranging from December 31, 2007 to December 31,
2009. Where appropriate, FIFRA Section 3 tolerances will be established for these crops; e.g.,
permanent tolerance for aspirated grain fractions. Although time-limited tolerances were
established in the past for dry bean, dry bean forage, and dry bean hay, these tolerances
expired on December 31, 2005.
d. Tolerances with Regional Registrations Established
Under 40 CFR §180.434(c)
Tolerances with regional registrations have been established for the following RACs as
defined: mint, tops (leaves and stems) and wild rice. The tolerance for mint is restricted to use
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west of the Cascade Mountains only, and the tolerance for wild rice is restricted to Minnesota.
Sufficient field trial data are available to reassess the established tolerances with regional
registrations for mint and wild rice at the same levels.
3. Codex Harmonization
The Codex Alimentarius Commission has established several maximum residue limits
(MRLs) for propiconazole in/on various raw agricultural commodities. The Codex MRLs are
expressed in terms of propiconazole per sc\ which is harmonized with the US tolerance
expression. EPA has harmonized tolerance levels on most commodities with Codex MRLs to
the extent possible. A comparison of the Codex MRLs and corresponding reassessed U.S.
tolerances is presented in Table 30.
Tabic 30. Codex MRLs for Propiconazole and
Applicable U.S. Tolerances.
Reassessed
Current Codex MRLs
Commodity
(As Defined by Codex)
MRL
(mjj/kji)
Step
U.S.Tolcrancc
(ppm)
Recommendation and Comments
Almonds
0.05
CXL
N/A
No current U.S. registration.
Banana
0.1
CXL
0.2*
Unable to harmonize due to higher U.S.
use rate.
Barley (grain)
0.05
CXL
0.3*
Unable to harmonize due to higher U.S.
use rate.
Coffee beans
0.1
CXL
N/A
No current U.S. registration.
Edible offal
(mammalian)
0.05
CXL
N/A
No current U.S. registration.
Eggs
0.05
CXL
N/A
MRL set at limit of quantification
(LOQ). Current U.S. tolerance of 0.1
will be revoked because poultry
metabolism data show no finite residues
in eggs.
Grapes
0.5
CXL
N/A
No current U.S. registration
Mango
0.05
CXL
N/A
No current U.S. registration.
Meat (from mammals
other than marine)
0.05
CXL
0.1*
MRL set at LOQ. Unable to harmonize
due to higher U.S. use rate.
Milks
0.01
CXL
0.05*
Unable to harmonize due to higher U.S.
use rate. MRL set at LOQ.
Oat (grain)
0.05
CXL
0.1
MRL set at LOQ.
Peanut
0.05
CXL
0.1*
Unable to harmonize due to higher U.S.
use rate.
Peanut, whole
0.1
CXL
N/A
Not currently regulated by U.S. EPA.
Pecan
0.05
CXL
0.1*
Unable to harmonize due to higher U.S.
use rate.
Poultry meat
0.05
CXL
N/A
No current U.S. registration. MRL set at
LOQ.
Rape seed
0.05
CXL
N/A
No current U.S. registration.
Rye
0.05
CXL
0.3*
MRL set at LOQ. Unable to harmonize
due to higher U.S. use rate.
Stone fruits
1.0
CXL
1.0
U.S. established crop group tolerance for
stone fruits.
Sugar beet
0.05
CXL
N/A
No current U.S. registration.
Sugar beet leaves or
tops
0.5
CXL
N/A
No current U.S. registration.
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Tabic 30. Codex MRLs for Propiconazole and Applicable U.S. Tolerances.
Current Codex MRLs
Reassessed
Commodity
(As Defined by Codex)
MRL
(mjj/ks)
Step
U.S.Tolcrancc
(ppm)
Recommendation and Comments
Sugar cane
0.05
CXL
N/A
Registered in U.S. for use as seed piece
treatment, which is considered a non
food use.
Wheat
0.05
CXL
0.30*
Unable to harmonize due to higher U.S.
use rate. MRL set at LOQ.
* US Tolerance cannot be harmonized with Codex MRLs because US GAP requires higher tolerances than Codex
MRL.
4. Residue Analytical Method
Plant commodities. Residue methods AG-454, AG-454B and AG-626 (both are
modification of method AG-454) were used to determine residues of propiconazole and its
metabolites on samples of raw agricultural and processed commodities from field trials and
processing studies. The methods use a single moiety detection in which residues are converted
to 2,4-DCBA, determined as the 2,4-DCB A methyl ester, and reported as propiconazole
equivalents using a conversion factor of 1.79. The reported level of quantification (LOQ) for
this method is 0.05 ppm. Concurrent method recoveries were acceptable. Previously, EPA
required enforcement method validation for Method AG-454A using bananas. These data are
no longer needed.
For enforcement purposes, residue method AG-354 is available for the determination
of propiconazole per se in/on plant commodities using gas chromatography and flame
ionization detection, and the reported LOQ is 0.05 ppm. The Multiresidue Methods Section
302 (Luke Method; Protocol D) also picks up parent propiconazole.
Animal commodities. Residue methods AG-517 and AG-629 (a modification of
method AG-517) were used for determination of propiconazole and its metabolites in animal
commodities. The methods use a single moiety detection in which residues are converted to
2,4-DCBA, determined as the 2,4-DCBA methyl ester, and reported as propiconazole
equivalents using a conversion factor of 1.79. The method LOQ is 0.05 ppm for residues in
meat, poultry, and eggs and 0.02 ppm for residues in milk. Samples from the ruminant and
poultry feeding studies were analyzed using method AG-359 (an early version of method AG-
517) and method AG-517. For enforcement purpose, the Multiresidue Methods Section 302
(Luke Method; Protocol D) picks up parent propiconazole.
Multiresidue methods. The October 1999 FDA PESTDATA database (PAM Volume
I, Appendix I) indicates that propiconazole is completely recovered (>80%) using Multiresidue
Methods Section 302 (Luke Method; Protocol D). The recovery of propiconazole metabolites
CGA-91305, CGA-118244, and 1,2,4-triazole is variable using Section 302. Propiconazole
and metabolites CGA-91305, CGA-118244, and 1,2,4-triazole are not recovered using
Multiresidue Methods Sections 303 (Mills, Onley, and Gaither; Protocol E, nonfatty) and 304
(Mills, fatty food).
E. Regulatory Rationale
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The following is a summary of the rationale for mitigation measures necessary for
managing risks associated with the use of propiconazole and for products containing
propiconazole to be eligible for reregistration. Where labelling revisions are warranted,
specific language is set forth in Table 31 of this document.
1. Human Health Risk Management
a. Aggregate Risk Mitigation for Propiconazole
Acute, short-term, and chronic aggregate risks for propiconazole are below the
Agency's level of concern. EPA has considered the contribution of acute and chronic dietary
exposure from food and drinking water as well as exposures to residential handlers and post-
application residential exposures in the aggregate risk assessment for propiconazole.
Therefore, no mitigation is necessary at this time. However, a wood wipe study is required for
propiconazole to confirm EPA's conclusions on post-application residential exposure to
treated wood.
b. Aggregate Risk Mitigation for Free Triazoles
Acute, short- and intermediate-term, and chronic aggregate risks for the 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 mitigation is necessary at this
time.
c. Occupational Risk Mitigation
A wide range of factors is considered in making risk management decisions for worker
risks. These factors include, in addition to the estimated MOEs, incident data, the nature and
severity of adverse effects observed in the animal studies, uncertainties in the risk assessment,
alternative registered pesticides, the importance of the chemical in integrated pest management
(IPM) programs, and other factors. Mitigation measures may include reducing application
rates, adding personal protective equipment (PPE) to end-product labels, requiring the use of
engineering controls, and other measures.
Occupational exposure assessments are completed by the Agency considering the use
of baseline PPE and, if warranted, for handlers, increasing levels of PPE and engineering
controls in order to estimate the potential impact on exposure and risk. The target MOE for
propiconazole is 100, based on information provided in Section III of this document. When
MOEs for occupational risk are less than 100, EPA strives to reduce worker risks through the
use of PPE and engineering controls or other mitigation measures. In some cases, the Agency
may accept MOEs less than 100 when all mitigation measures that are feasible and practical
have been applied, particularly when there are critical pest management needs associated with
the use of the pesticide.
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Handler Risk Mitigation
Agricultural Uses. The Agency evaluated handler risks for both liquid and wettable
powder formulations of propiconazole. For liquid formulations, handler risks for most
scenarios were of concern for mixer/loaders wearing baseline clothing (long sleeve shirt, long
pants, shoes, and socks), but these risks can be mitigated with the addition of chemical-
resistant gloves (i.e., MOEs with gloves are >100). Therefore all handlers using liquid
formulations of propiconazole must wear chemical-resistant gloves and all labels must reflect
this requirement. For wettable powders, which are all formulated in water-soluble packs,
handler risks were below the Agency's level of concern (MOEs are >100) with baseline
clothing. Provided that all wettable powder formulations are in water-soluble packs, no
additional mitigation is necessary. In addition, gloves are required for all handlers involved in
seed piece treatments or dips because seed piece treatment is a potentially messy operation. All
current propiconazole labels require gloves for this use.
Antimicrobial Uses. Material Preservative. The Agency evaluated handler risks
associated with use of propiconazole as a material preservative in paints, caulks, textiles, and
as a wood preservative. When propiconazole is used as a material preservative, short-term
handler MOEs range from < 1 to 6,500 at baseline (long-sleeved shirt, long pants, shoes and
socks) and from 300 to 26,000 with the addition of chemical-resistant gloves. Likewise,
intermediate-term handler MOEs range from < 1 to 2,200 at baseline and 100 to 8,600 with
chemical-resistant gloves. Workers applying paint containing propiconazole as an in-can
preservative have a combined short-term MOE of 75 for airless sprayer and intermediate-term
MOEs of 55 and 25, for brush/roller or airless sprayer, respectively, at baseline. Although the
use of chemical-resistant gloves improves the MOEs for painting, EPA cannot require workers
using paint containing propiconazole to wear gloves because paint is considered a treated
article when it contains propiconazole as an in-can preservative. Treated articles are exempt
from FIFRA labeling requirements.
To mitigate risk to painters, the registrant has agreed to decrease the amount of
propiconazole that may be used as a preservative in paint from 0.35% to 0.125% a.i. When
paint contains 0.125%> propiconazole, MOEs are expected to increase about threefold,
resulting in short- and intermediate-term MOEs for painters using brush/roller >100; and
MOEs for painters using an airless sprayer >100 for short-term exposure and -75 for
intermediate-term exposure. However, there is some uncertainty in the dermal component of
these MOEs because the underlying exposure monitoring data is from cooling tower workers
(no gloves) rather than from painters, and only two replicates are available for cooling tower
exposure. Because of these uncertainties, the Agency is requiring additional worker exposure
monitoring studies for painters using brush rollers and airless sprayers as confirmatory data.
The propiconazole registrants are members of the Antimicrobial Exposure Assessment Task
Force II (AEATF II), which will be conducting these studies. In addition, EPA is assuming
that 40%o of propiconazole in paint is biologically available and absorbed through the skin,
based on a rat dermal penetration study with technical grade propiconazole. However, this
may differ from the absorption of propiconazole in paint because the paint matrix may limit
dermal absorption. Registrants have agreed to conduct a dermal absorption study to determine
how much propiconazole is absorbed through the skin when this chemical is suspended in a
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paint matrix. EPA is requiring a dermal absorption study for a paint product containing
propiconazole as part of this RED. At this time, the Agency believes that reducing the percent
active ingredient in paint is sufficient to mitigate risk concerns for painters, given the
uncertainties in underlying exposure monitoring data and dermal absorption of propiconazole
in paint.
Wood Preservative. For blender/spray operators, chemical operators, and diptank operators,
short-term combined MOEs range from 400 to 850 with gloves, and intermediate-term MOEs
range from 130 to 280 with gloves. Handler MOEs for high-pressure/high volume spray treatment
range from 150 to 1,500 for short-term exposure and from 50 to 500 for intermediate-term
exposure; these MOEs assume the use of chemical-resistant gloves. The MOE of 50 is for
application of propiconazole to mushroom houses in a high volume spray of 1000 gallons per day.
However, according to Phase 3 comments from the American Mushroom Institute, no more than
100 gallons are applied in a mushroom house in a given day (MOE is 500), thus addressing the risk
concern. For workers pressure treating wood, the combined short-term MOE ranges from 260 to
2,200 and the intermediate-term MOE ranges from 86 to 730 with gloves. For workers pressure
treating wood, the combined intermediate-term dermal and inhalation MOE is 86 with gloves,
which falls within the negligible risk range. Also, EPA used monitoring data for other wood
preservatives to estimate handler exposure to propiconazole used as a wood preservative. This
assumes that the exposure patterns at treatment facilities using other wood preservatives would
be the same as for propiconazole. Given this uncertainty, no mitigation is warranted at this
time, but a confirmatory worker monitoring study for pressure treatment of wood will be
required as part of this RED. Registrants have agreed to conduct this additional worker
exposure monitoring study.
Post-Application Worker Risk Mitigation
Agricultural Uses. Agricultural workers re-entering sites previously treated with
propiconazole have short-term MOEs ranging from 150 to 36,000 on the day of pesticide
application. Because these MOEs are all below the Agency's level of risk concern, no
mitigation is necessary. Intermediate-term MOEs for re-entry workers range from 97 (for cut
flowers) to 37,000. However, all MOES are > 100 on the day after pesticide application;
including the MOE for cut flowers, which is 104. Although the MOE on is slightly less than 100
on day 0, EPA considers this MOE of 97 to be within the same negligible risk range as the MOE of
104 on day 1. Therefore, the Agency does not believe that the risk reduction justifies a 24 hour REI
for propiconazole. The current restricted-entry interval (REI) for propiconazole is 12 hours on some
labels; which is consistent with the Worker Protection Standard (WPS) requirement based on the
acute toxicity of technical propiconazole (Toxicity Category III). The REI may increase
depending on the toxicity of propiconazole end-use products; this will be determined during
product reregistration.
Antimicrobial Uses. Machinists who are exposed to propiconazole in metal working
fluids have a combined short-term inhalation and dermal MOE of 4,800 and a combined
intermediate-term MOE of 1,600. Because these MOEs are > 100, and below the Agency's
level of concern, no mitigation is needed for post-application risk from metalworking fluids.
Saw mill workers who are exposed to wood after it is treated have short-term dermal MOEs
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ranging from 150 to 2,700 and inhalation MOEs ranging from 150 to 5,500. Intermediate-
term MOEs (for workers exposed for a longer duration) range from 51 to 2000 for dermal
exposure and 1,900 to 44,000 for inhalation exposure. Intermediate-term dermal MOEs are of
concern only for one scenario: workers performing clean up activities. However, these MOEs
are based on data for a surrogate chemical, which is also used as a wood preservative in saw
mills, but with a different percent active ingredient, application rates, etc. As previously
mentioned, there are no adequate data showing how much propiconazole residue is dislodged
from treated wood. As a result, EPA believes that the risk to clean up crew workers is an
overestimate and risks are not of concern. Moreover, all other exposure scenarios for this
industry are low and not of concern, and it is not practical to impose restrictions. To address
these uncertainties EPA is requiring confirmatory exposure monitoring data for post-
application workers handling wood treated with propiconazole as well as the confirmatory
wood wipe study previously mentioned.
2. Non-Target Organism (Ecological) Risk Management
Ecological risk mitigation measures may include lowering application rates, reducing
the number of applications allowed in a year, restricting the timing of applications, extending
the time between applications, and changing pesticide use to minimize runoff or spray drift. In
some situations, certain uses or application methods may need to be deleted to address
ecological risk concerns.
The screening-level risk assessment for propiconazole suggests that exposure to
propiconazole is likely to result in some exceedance of EPA's acute or endangered species
LOC for birds, mammals, terrestrial and aquatic plants, and chronic LOC for mammals.
However, for birds, the acute RQ of 0.53 is very close to the LOC of 0.5. The Agency has
addressed these risk concerns to the extent feasible while considering some of the factors listed
above. Specific risk mitigation measures are described in the following sections.
EPA does not currently have enough chronic toxicity data to quantify risks for
propiconazole for freshwater invertebrates (Daphnia) and estuarine/marine fish, because of
outstanding data requirements from a previous DCI. Chronic toxicity data must be submitted
to support the continued registration of propiconazole.
a. Terrestrial Organisms
Birds and Mammals
Mammals. Acute mammalian RQs for propiconazole are below the LOC for all
propiconazole uses except turf. The acute mammalian RQs for turf exceeded the listed species
LOC for mammals feeding on short grass, tall grass, or broadleaf forage and small insects. Acute
RQs for multiple applications of propiconazole to turf exceeded the acute LOC of 0.5 for 15 g and
35 g smaller mammals in the short grass food category only. When the Agency revised the RQs
for turf using chemical-specific data on foliar dissipation half-life, rather than the 35 day default
used in the original screening-level risk assessment, only acute RQs for small mammals feeding on
short grass exceeded the LOC. However, with the revised RQs, the listed species LOC of 0.1 is
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exceeded for all weight classes of mammals feeding on short grass, tall grass, and broadleaf plants
and small insects. In the screening-level risk assessment for propiconazole, EPA used the labeled
turf application rate of 1.78 lbs ai/A with 2-4 applications per year. Actual use data show that much
lower rates and fewer applications are used, even in the states with the greatest use.
Although the revised RQs were calculated with propiconazole-specific foliar dissipation
data, the data set was small. The resulting RQs could overestimate or underestimate potential risk
to mammals. Therefore, a confirmatory foliar dissipation study is required as part of this RED.
This study would measure dissipation of propiconazole over time from foliage of several
representative crop groups.
Chronic risks to mammals were calculated using both the dietary and dose-based RQs.
Dietary based mammalian RQs based on maximum residues ranged from 1.1 to 2.6 and exceeded
the chronic LOC for multiple applications to turf. However, dose-based chronic RQs were as high
as 13 for mammals foraging in short grass following multiple applications of propiconazole to turf.
For turf, chronic RQs only begin to exceed LOCs after the 3rd application and no chronic LOCs are
exceeded after 2 applications. RQs based on mean residues would be lower. Acute risks would
also be lower based on fewer applications. All other exposure scenarios resulted in RQs below the
Agency's LOC. When EPA refined the chronic dose-based RQs as mentioned above, the only
chronic RQs exceeding the LOC are for small mammal feeding on short grass following application
of propiconazole to pecans (the RQ of 1.04 only barely exceeds the LOC of 1). For turf, chronic
RQs exceed the Agency's chronic LOC for mammals feeding on grasses, broadleaf plants, and
small insects.
The greatest use of propiconazole on turf occurs in the Midwestern United States, New
York, and Pennsylvania. EPA proprietary data show that lawn care operators applied 15,000
lbs annually, and turf management and nursery and greenhouse operations applied 75,000 lbs
annually from 1998 to 2001. Average annual application rates to golf course turf range from
0.2 to 1.3 lbs ai/A, with 17 states reporting annual use propiconazole at an average annual rate
of 0.5 lb ai/A or less. In states with the greatest use, the average annual application rate
ranged from 0.7 to 1.2 lbs ai/A. The mammalian RQs presented above are based on multiple
applications at the labelled application rate of 1.78 lbs ai/A, and are therefore believed to
overstate risk to mammals from typical use.
Birds. Avian acute RQs only exceed the Agency's LOC of 0.5 for turf and ornamental
uses, when the smallest weight class of birds feeding on short grass following multiple
propiconazole applications; for this scenario acute RQs range from 0 to 0.7. When these RQs were
refined by using chemical-specific foliar dissipation half-life data, only the RQ of 0.53 for the
smallest weight class of birds feeding on short grass exceeded the LOC of 0.5. Also, based on
predicted maximum residues and multiple applications to turf and ornamentals, acute RQs exceed
the listed species LOC of 0.1 for all weight classes of birds feeding on short grass and tall grass
and for smaller birds feeding on broadleaf forage and small insects. Based on predicted, mean
residues resulting from multiple applications to turf and ornamentals, only birds feeding on short
grass exceed the endangered species LOC. Avian RQs did not exceed LOCs for any other uses.
Dietary-based chronic avian RQs slightly exceed the LOC for the turf use. However, the
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chronic toxicity study for birds showed no treatment-related effects at any of the test levels up to
1000 mg/kg diet and, as such, a LOAEC could not be determined. Consequently, the actual
NOAEC could be much greater than that observed in the study used to assess chronic avian risk and
the RQs could be lower. Dietary-based chronic avian RQs only slightly exceeded the LOC of 1 for
multiple applications to turf; the highest RQ was 1.3. In addition, when these RQs were further
refined by using chemical-specific foliar dissipation half-life data, the maximum RQ is 1.02 and
equivalent to the chronic LOC of 1. Therefore, at this time, EPA does not have a concern for
chronic risks to birds and no mitigation is necessary.
Non-Target Insects
EPA does not have sufficient data to determine whether propiconazole use poses
potential risks to non-target insects. However, the Agency does not expect adverse effects to
insects because propiconazole does not cause adverse effects to soil microbes or earthworms.
Plants
Propiconazole poses a potential risk to terrestrial plants for some uses. Non-listed and listed
species RQs resulting from single applications of propiconazole range from <1 to 7.95. RQs
exceed the LOC for nonlisted dicots based on use on turf and listed dicots based on use in grasses
grown for seed, rice, wild rice, peanut, and turf use. Dicot RQs for a single application of
propiconazole to turf and ornamentals range from 0.59 to 2.47 for non-listed species and 0.32
to 7.95 for listed species. Monocot RQs exceed only the LOC for listed species following a
single application to turf and ornamentals; no other RQs exceed the LOC. As previously
mentioned, the RQ for turf and ornamentals assumes application to turf at the maximum label
rate 1.78 lb ai/A; which is greater than the actual rates used on turf (maximum of 0.7 to 1.2 lbs
ai/A).
As previously mentioned, underlying assumptions used to derive plant RQs introduce some
uncertainty into the conclusions of the screening-level risk assessment. For example, the Terr-
PLANT model assumes that 2% for propiconazole is lost to runoff from each of ten acres of a
treated field to non-target plants adjacent to the treated field. The Agency is currently developing a
plant exposure model which, among other things, will use PRZM to estimate the amount of
pesticide in runoff based on the persistence and mobility of the chemical, and soil and weather data
in specific crop scenarios. Although this refined exposure model is not yet available, the transport
of propiconazole in runoff from use on turf was estimated by PRZM as part of the aquatic risk
assessment, and can be used to further characterize the potential for risk to terrestrial dicots.
The TERR-PLANT model assumed an EEC of 0.36 lb ai/A from a single application of
1.78 lb ai/A on turf. The transport of propiconazole from the peak runoff event for each of 30 years
simulated by PRZM ranged from 0.009 lb ai/A to 0.245 lb ai/A. These EECs, which reflect 4
applications of propiconazole at 1.78 lb ai/A, would result in acute RQs ranging from 0.05 to 1.4 if
used in the risk assessment. Peak storm events simulated by PRZM would result in RQs at or
above the LOC of 1.0 in 7 of the 30 years simulated, indicating a potential risk to plants adjacent to
treated fields under certain conditions if the maximum rate and number of applications are applied.
Use data indicate that typical rates in the states with the greatest use range from 0.7 to 1.2 lbs ai/A
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per year. Since these typical rates are at least one-third less than the maximum rate, the 25% effect
on seedling emergence represented by the toxicity endpoint might occur even less frequently than
suggested by the PRZM model output.
The Agency believes that the label changes to address spray drift will also reduce
potential risks to terrestrial plants. The Ag-DRIFT model shows deposition of fine to medium
size spray droplets at levels equal to the vegetative vigor EC25 at distances ranging from 3 to
43 feet from the treated field. The spray drift mitigation will require use of medium coarse to
coarse spray droplets to minimize drift. This larger droplet size is expected to reduce the
distance from the treated field at which nontarget plants would be at risk for adverse effects
(vegetative vigor). If one runs an Ag-DRIFT simulation using this larger droplet size
spectrum, RQs for the three less sensitive plants would be below the the LOC at distances beyond 3
feet from the treated field; and the RQ for the most sensitive plant would be below the LOC at
distances beyond 13 feet from the field. The distance to which deposition is at or above the LOC
for the aerial application to grass grown for seed, pecans, rice, wild rice and peanuts is reduced from
49 feet to 26 feet, based on the most sensitive plant tested. As with seedling emergence, the
vegetative vigor LOC represents an effect (mainly plant height here, or dry weight) to 25% of test
plants. The distance to which the endangered species LOC (based on the no observed adverse
effect level) is met is reduced by spray drift mitigation from 92 feet to 33 feet for the turf use, and
from 118 feet to 75 feet for the aerial uses at 0.225 lb ai/A, based on the most sensitive plant tested.
b. Aquatic Organisms
Freshwater Fish and Invertebrates
All RQs for freshwater fish and invertebrates are less than the Agency's LOC of 0.5 for
acute risk. These RQs are considered to be conservative because they are based on the
maximum 1 in 10 year peak surface water concentrations and the most sensitive 96-hour LC50
values for fish and aquatic invertebrates. For endangered species, however, the freshwater fish
RQ is equal to the acute listed species LOC of 0.05 based on EECs in surface water from turf
use in Pennsylvania, but does not exceed based on EECs in surface water from turf use in
Florida.
Chronic RQs for freshwater fish do not exceed the Agency's chronic LOC of 1 based
on average surface water concentrations of propiconazole resulting from the highest exposure
scenarios, for use on turf and rice, and available toxicity data. As previously mentioned, the
Agency does not have sufficient data to assess chronic risks from propiconazole uses to
estuarine/marine fish or freshwater invertebrates.
Estuarine/Marine Fish and Invertebrates
The Agency's screening-level risk assessment shows that RQs for estuarine/marine fish do
not exceed the acute LOC for any use, but exceed the listed species LOC for the rice use. The
estuarine/marine invertebrate acute RQs exceed the acute listed species LOC (0.05) from the
highest exposure scenarios, for use on turf and rice. The risk assessments must be further refined to
determine whether propiconazole use on turf or rice is likely to occur in areas inhabited by
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endangered species. As previously mentioned, the acute RQs are based on conservative inputs,
including the maximum l-in-10 year peak EEC and the most sensitive 90-hour LC50 value. In
addition, the modeled application rate for turf is higher than what is actually used, even in the areas
of greatest use. Furthermore, only one application of propiconazole is made to rice in most states,
but two applications were modeled. No levels of concern were exceeded for any other crops.
Chronic RQs for estuarine/marine invertebrates do not exceed the Agency's chronic
LOC of 1 based on average surface water concentrations of propiconazole resulting from both
the turf and rice scenarios and available toxicity data. As previously mentioned, EPA does not
have sufficient data to assess chronic risks from propiconazole uses to estuarine/marine fish.
Plants
RQs for freshwater vascular plants based on both turf and rice use and the RQs for
freshwater non-vascular plants based on turf use do not exceed the LOC. The use of
propiconazole on rice and turf may present risk to non-vascular estuarine/marine plants; both
the acute and listed species RQs exceed the LOC of 1. In addition, the use of propiconazole
on rice may present an acute risk to freshwater non-vascular plants; the listed species RQs
exceed the LOC of 1. However, as previously stated, the RQs are based on higher than typical
application rates for turf, and the RQs for rice are based on two applications, where one
application is commonly used.
3. Summary of Mitigation Measures
The following mitigation measures are necessary for the active ingredient
propiconazole and for end-use products containing propiconazole to be eligible for
reregistration. These include use restrictions, voluntary cancellations and/or use deletions, and
personal protective equipment.
• Handlers using liquid formulations of propiconazole for agricultural use must wear
chemical-resistant gloves;
• Handlers using propiconazole for seed piece treatment or dips must wear chemical-
resistant gloves;
• Wettable powder formulations of propiconazole must be packaged in water-soluble
bags;
• Decrease the amount of propiconazole that may be used as a preservative in paint from
0.35% to 0.125% a.i.; and
• Label restrictions to minimize spray drift, including restrictions on droplet size and
application height.
Because the technical registrants have requested that the following uses be deleted from all
labels, they are not eligible for reregistration:
• Use of propiconazole on apparel, carpet fibers, and home furnishings
Registrants have requested that their registration be amended to delete these uses; and EPA
issued a formal order deleting these uses on May 26, 2006. Therefore, these uses are not being
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considered for reregistration.
F. Other Labeling Requirements
To be eligible for reregistration, various use and safety information will be included in
the labeling of all end-use products containing propiconazole. For the specific labeling
statements and a list of outstanding data, refer to Section V of this RED document.
1. Endangered Species Considerations
As stated in Chapter in of this document, the Agency's screening-level assessment
preliminary risk assessment for propiconazole indicates a potential for adverse effects on listed
species as noted below, should exposure actually occur at modeled levels:
Terrestrial organisms
• Mammals
o Acute RQs for turf and ornamentals exceed LOCs for small mammals
feeding on short grass, tall grass, broadleaf forage and small insects;
o Chronic RQs for turf and ornamentals exceed LOC for all mammals
feeding on short grass, tall grass, broadleaf forage and small insects;
• Birds
o Acute RQs for turf and ornamentals exceed LOCs for all birds feeding
on short grass and tall grass and for smaller birds feeding on broadleaf
forage and small insects;
o Chronic RQs for turf and ornamentals barely exceed the LOC.
Although these RQs were based on a study that showed no effects at the
highest dose tested; EPA cannot preclude potential adverse effects to
listed species;
• Plants
o Acute RQs for turf and ornamentals exceed LOCs for listed terrestrial
plants (monocots and dicots) adjacent to treated sites and in semi-
aquatic areas;
o Acute RQs for grasses grown for seed, rice, and peanuts are equal to the
LOC for dicots in semi-aquatic areas;
Aquatic Organisms
• Freshwater
o Acute fish RQ for Pennsylvania turf is equal to LOC for listed species;
Florida turf scenario does not exceed LOC;
o Acute fish RQ for rice exceeds LOC for listed species;
o Because no data are available to evaluate chronic risks to freshwater
invertebrates, EPA has a potential concern for listed species;
• Estuarine/Marine
o Acute invertebrate RQs for turf and rice exceed LOC for listed species;
o Because no data are available to evaluate chronic risks to
estuarine/marine fish, EPA has a potential concern for listed species;
• Plants
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o Acute RQs for turf exceed LOCs for listed estuarine/marine nonvascular
plants; and
o Acute RQs for rice exceed LOCs for listed freshwater and
estuarine/marine nonvascular plants.
Further, potential indirect effects to any species dependent upon a species that experiences
effects from use of propiconazole cannot be precluded based on the screening-level ecological risk
assessment. These findings are based solely on EPA's screening-level assessment and do not
constitute "may affect" findings under the Endangered Species Act.
The Agency has developed the Endangered Species Protection Program to identify
pesticides whose use may cause adverse impacts on endangered and threatened species, and to
implement mitigation measures that address these impacts. The Endangered Species Act (ESA)
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 it in relation to individual species and their locations by evaluating important
ecological parameters, pesticide use information, geographic relationship between specific pesticide
uses and species locations, and biological requirements and behavioral aspects of the particular
species, as part of a refined species-specific analysis. When conducted, this species-specific
analysis will take into consideration any regulatory changes recommended in this RED being
implemented at that time.
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
propiconazole; 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 propiconazole "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 propiconazole at
levels of concern. EPA is not requiring specific propiconazole 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.
2. Spray Drift Management
The Agency has been working closely with stakeholders to develop improved
approaches for mitigating risks to human health and the environment from pesticide spray and
dust drift. As part of the reregistration process, EPA will continue to work with all interested
parties on this important issue.
From its assessment of propiconazole, as summarized in this document, the Agency
concludes that certain drift mitigation measures are needed to address the risks from off-target
drift for propiconazole, including a requirement for medium to coarse droplet size. Label
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statements implementing these measures are listed in the "spray drift management" section of
the label table (Table 31) in Section V of this RED document. In the future, propiconazole
product labels may need to be revised to include additional or different drift label statements.
V. What Registrants Need to Do
The Agency has determined that propiconazole is eligible for reregistration, provided
that the risk mitigation measures outlined in this document are adopted and label amendments
are made to reflect these measures. To implement the risk mitigation measures, the registrants
will be required to amend their product labeling to incorporate the label statements set forth in
the Label Summary Table (Table 31). In the near future, the Agency intends to issue Data
Call-In Notices (DCIs) requiring label amendments, product specific data and additional
generic (technical grade) data. Generally, registrants will have 90 days from receipt of a DCI
to complete and submit response forms or request time extension and/or waiver requests with a
full written justification. For product-specific data, the registrant will have eight months to
submit data and amended labels. For generic data, due dates can vary depending on the
specific studies being required. Below are tables of additional generic data and label
amendments that the Agency intends to require for propiconazole to be eligible for
reregistration.
A. Manufacturing Use Products
1. Generic Data Requirements
The generic database supporting the reregistration of propiconazole for the above
eligible uses has been reviewed and determined to be substantially complete. However, there
are a few outstanding generic data requirements for residue chemistry, aquatic toxicity, and
environmental fate remaining, which must fulfilled to support the continued registration of
propiconazole. (See Data Gaps listed in Appendix B.) These outstanding data requirements,
were included in previous DCIs and therefore will not be included in the generic DCI for this
RED.
In addition, the Agency has identified data necessary to confirm the registration
eligibility decision for propiconazole. These studies are listed herein and will be included in
the generic DCI for this RED, which the Agency intends to issue at a future date.
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Human Health
OPPTS 860.1200
Directions for Use for Sunflower Breeder's Seed
OPPTS 860.1500
OPPTS GDLN 870.7600
OPPTS GDLN 875.1200
OPPTS GDLN 875.1400
OPPTS GDLN 875.1100
OPPTS GDLN 875.1300
Ecological Effects
OPPTS GDLN 876.7200
Special Studies
Crop Field Trials for Sunflower Breeder's Seed
Dermal Penetration (for Paint Containing Propiconazole)
Dermal Exposure - Indoor, for the following scenarios:
o Painters using brush/roller
o Painters using airless sprayer
o Workers pressure treating wood
o Workers handling treated wood
Inhalation Exposure - Indoor, for the following scenarios:
o Painters using brush/roller
o Painters using airless sprayer
o Workers pressure treating wood
o Workers handling treated wood
Dermal Exposure - Outdoor, for painters using brush roller and
airless sprayer
Inhalation Exposure - Outdoor, Outdoor, for painters using
brush roller and airless sprayer
Soil Residue Dissipation - modified for foliage dissipation
Dislodgeable Residues of Propiconzole from treated Wood
(wood wipe study for dimensional lumber)
Data Requirements for Free Triazoles
The Agency is also requiring additional data for the free triazoles, 1,2,4-triazole,
triazole alanine, and triazole acetic acid. However, any DCIs for the free triazoles will be
issued separately from the DCI for propiconazole.
2. Labeling for Manufacturing Use Products
To ensure compliance with FIFRA, manufacturing use product (MUP) labeling should
be revised to comply with all current EPA regulations, PR Notices, and applicable policies.
The MUP labeling should bear the labeling contained in Table 31.
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B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed 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. The Agency intends to issue a separate product-
specific data call-in (PDCI) outlining specific data requirements.
2. Labeling for End-Use Products
To be eligible for reregistration, labeling changes are necessary to implement measures
outlined in Section IV above. Revised labels are due 8 months from the date of receipt of the
PDCI mentioned above. Specific language to incorporate these changes is provided in Table
31. Generally, conditions for the distribution and sale of products bearing old labels/labeling
will be established when the label changes are approved. However, specific existing stocks
time frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors.
C. Labeling Changes Summary Table
For propiconazole to be eligible for reregistration, all propiconazole labels must be
amended to incorporate the risk mitigation measures outlined in Section IV. Table 31
describes how language on the labels should be amended.
D. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 18
months after the date of approval of revised labels implementing the changes described in this
RED. Others, including end-use registrants, may generally sell, distribute, and use existing stocks
bearing previously approved labeling until these existing stocks have been exhausted, provided
such sale, distribution, and use are in accordance with previously approved labeling. Existing
stocks are defined as stocks of registered pesticide products currently in the United States, which
have been packaged, labeled, and released for shipment. EPA's existing stocks policy is described
in the Federal Register of June 26, 1991 (56 FR 29362; FRL-3846-4).
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Tabic 31. Summary of Labeling Changes for Propiconazolc
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Products
For all Manufacturing Use
Products
"Only for formulation into afungicide/material preservati veA mod preservative for the following uses: -
[Registrant, please insert]."
"Unless packaged in water-soluble packaging, this product may not be formulated into wettable powder
end-use products."
"This product may not be formulated into end-use products for use in carpet fibers, apparel, and
furnishings (except shower curtains)."
"This product may not be formulated into paints and stains unless the maximum concentration of
propiconazole is less than or equal to 0.125% by weight."
Directions for Use
Environmental Hazards
Statements
"ENVIRONMENTAL HAZARDS"
"This product is toxic to fish and shrimp. 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 Eliminations 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 Environmental Protection Agency."
Precautionary Statements:
Environmental Hazards
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Tabic 31. Summary of Labeling Changes for Propiconazolc
Description
Amended Labeling Language
Placement on Label
End-Use Products Intended for Occupational Use (WPS and Non-WPS)
PPE Requirements* for
Wettable Powder (WP)
Formulations.
Wettable Powder products
labeledfor use on
agricultural or ornamental
crops must be packaged in
water soluble packaging to
be eligible for
reregistration.
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are [Registrant, please insert correct
material(s).] Follow the instructions for category [insert A, B, C, D, E, F, G, or H] on the chemical-
resistance category selection chart in the EPA Label Review Manual, 3rd Edition (EPA-735-B-03-001,
August 2003).
"Mixers, loaders, applicators, and other handlers must wear:
- long-sleeved shirt and long pants,
- shoes and socks."
"In addition, mixers/loader must wear
- chemical-resistant gloves and
- a chemical-resistant apron."
"All handlers using propiconazole as a seed piece treatment must wear
- chemical-resistant gloves and
- a chemical-resistant apron."
"See Engineering Controls for additional requirements."
Immediately following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
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Tabic 31. Summary of Labeling Changes for Propiconazolc
Description
Amended Labeling Language
Placement on Label
PPE Requirements* for
Liquid Concentrate
Formulations
For all liquid formulations
labeledfor use on
agricultural or ornamental
crops,
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are [registrant inserts correct material(s)]."
For more options, follow the instructions for category [insert A, B, C, D, E, F, G or H] on the chemical-
resistance category selection chart in the EPA Label Review Manual, 3rd Edition (EPA-735-B-03-001,
August 2003).
"All handlers must wear:
- long-sleeved shirt and long pants,
- shoes and socks, and
- chemical-resistant gloves."
"In addition, all handlers (mixers, loaders, and applicators, or individuals performing one or more of
these tasks), who are applying this pesticide using hand-held equipment must wear
- long-sleeved shirt and long pants,
- shoes and socks, and
- chemical-resistant gloves."
"All handlers using propiconazole as a seed piece treatment must wear
- chemical-resistant gloves and
- a chemical-resistant apron. "
Immediately following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
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Tabic 31. Summary of Labeling Changes for Propiconazolc
Description
Amended Labeling Language
Placement on Label
PPE Requirements* for
Liquid Concentrate
Formulations
For all liquid formulations
labeledfor use as a
material preservative or
wood preservative.
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are [registrant inserts correct material(s)]."
For more options, follow the instructions for category [insert A, B, C, D, E, F, G or H] on the chemical-
resistance category selection chart in the EPA Label Review Manual, 3rd Edition (EPA-735-B-03-001,
August 2003).
"Mixers and loaders using liquid formulations must wear:
- long-sleeved shirt and long pants,
- shoes and socks, and
- chemical-resistant gloves."
Immediately following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
Engineering Controls
For all formulations
labeledfor use on
agricultural or ornamental
crops, aerial applicators
must use enclosed
cockpits.
Enclosed Cockpits
"Pilots must use an enclosed cockpit that meets the requirements listed in the Worker Protection Standard
(WPS) for agricultural pesticides [40 CFR 170.240(d)(6)]."
Immediately following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
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Tabic 31. Summary of Labeling Changes for Propiconazolc
Description
Amended Labeling Language
Placement on Label
Engineering Controls:
Wettable Powder
formulations must be
packaged in water soluble
packaging 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 in the PPE section of this labeling for mixers
and loaders
- be provided, and must have immediately available for use in an emergency, such as a broken
package, spill, or equipment breakdown, chemical-resistant gloves, chemical-resistant footwear,
and a PF 5 dust-mist respirator."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following the
PPE requirements
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 or 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
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
(Must be placed in a box.)
Environmental Hazards
Statements
"ENVIRONMENTAL HAZARDS"
For end use products containing directions for use on agricultural crops and ornamentals: "This product
is toxic to fish and shrimp. Do not apply directly to water, or to areas where surface water is present, or
to inter-tidal areas below the mean high water mark. Do not contaminate water when cleaning
equipment or disposing of equipment washwater or rinsate."
For end-use products intendedfor use as either a material preservative or wood preservative: "This
product is toxic to fish and shrimp. Do not apply directly to water. Do not contaminate water when
Precautionary Statements:
Hazards to Humans and
Domestic Animals
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Tabic 31. Summary of Labeling Changes for Propiconazolc
Description
Amended Labeling Language
Placement on Label
disposing of equipment wastewaters. 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 Eliminations 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 Environmental Protection Agency."
Restricted-Entry Interval
For products labeled for
use on agricultural or
ornamental crops.
"Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 12
hours."
Directions for Use, in
Agricultural Use
Requirements box
Early Reentry Personal
Protective Equipment
For Products Subject to
WPS as required by
Supplement 3 of PR Notice
93-7
"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 soil or water, is
- coveralls,
- shoes and socks, and
- chemical-resistant gloves made of any waterproof material."
Directions for Use, in
Agricultural Use
Requirements Box
General Application
Restrictions
"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
Application Restrictions
For products labeled for
use as material
preservatives
"Do not apply more than [Registrant, insert amount equal to 0.125% by weight] per gallon as a
preservative for paints and stains."
Directions for Use
Use Restrictions
For products labeled for
use on agricultural or
ornamental crops
Do not harvest rice until 45 days after last application of propiconazole. The preharvest interval (PHI) for
rice is 45 days.
Note: The maximum allowable application rate and maximum allowable rate per year must be listed as
pounds or gallons of formulated product per acre, not just as lbs ai/A.
Directions for Use
84
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Tabic 31. Summary of Labeling Changes for Propiconazolc
Description
Amended Labeling Language
Placement on Label
Spray Drift Label
Language for Products
Applied as a Spray
"Spray Drift Management"
"A variety of factors including weather conditions (e.g., wind direction, wind speed, temperature, relative
humidity) and method of application can influence pesticide drift. The applicator must evaluate all
factors and make appropriate adjustments when applying this product."
Wind Soccd
"Do not apply at wind speeds greater than 15 mph."
Droolct Size
"Apply as a medium or coarser spray (ASAE Standard 572)"
Temperature Inversions
"If applying at wind speeds less than 3 mph, the applicator must determine if a) conditions of temperature
inversion exist, or b) stable atmospheric conditions exist at or below nozzle height. Do not make
applications into areas of temperature inversions or stable atmospheric conditions."
Other State and Local Reauirements
"Applicators must follow all state and local pesticide drift requirements regarding application of
propiconazole. Where states have more stringent regulations, they must be observed."
Eauroment
"All application equipment must be properly maintained and calibrated using appropriate carriers or
surrogates."
Additional requirements for aerial applications:
1. "The boom length must not exceed 75% of the wingspan or 90% of the rotor blade diameter."
2. "Release spray at the lowest height consistent with efficacy and flight safety. Do not release spray at a
height greater than 10 feet above the crop canopy unless a greater height is required for aircraft safety."
3. "When applications are made with a crosswind, the swath must be displaced downwind. The
applicator must compensate for this displacement at the up and downwind edge of the application area by
adjusting the path of the aircraft upwind."
Directions for Use under
General Precautions or
Restrictions and/or
Application Instructions
85
-------
Tabic 31. Summary of Labeling Changes for Propiconazolc
Description
Amended Labeling Language
Placement on Label
Additional requirementfor groundboom application:
1. "Do not apply with a nozzle height greater than 4 feet above the crop canopy."
End Use Products Primarily Used by Consumers/Homeowners
Environmental
Hazards Statement
"ENVIRONMENTAL HAZARDS"
"This product is toxic to fish and shrimp. Do not apply directly to water. Do not contaminate water
when cleaning equipment or disposing of equipment washwaters or rinsate." "Drift and runoff may be
hazardous to aquatic organisms in water adjacent to treated areas."
Precautionary Statements
under Environmental Hazards
Entry Restrictions
Products applied as a spray:
"Do not allow adults, children, or pets to enter the treated area until sprays have dried."
Products applied dry:
"Do not allow adults, children, or pets to enter the treated area until dusts have settled."
Directions for use under
General Precautions and
Restrictions
General Application
Restrictions
"Do not apply this product in a way that will contact adults, children, or pets, either directly or through
drift."
Place in the Direction for Use
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. In the case of multiple active
ingredients, the more protective PPE must be placed on the product labeling. For guidance on which PPE is considered more protective, see PRNotice 93-7.
86
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VI. APPENDICES
APPENDIX Al. Propiconazo
e Food/Feed Use Patterns
Eligible for Reregistration (Case 3125)
Application Type
Application
Equipment
Formulation1
[EPA Reg. No.]
Maximum
Single
Application
Rate
(lb ai/A)
Maximum
Number of
Apps. per
Season
Maximum
Seasonal Rate
(lb ai/A)
Minimum
Application
Interval
(days)
Preharvest
Interval
(PHI)
(days)
Use Directions and Limitations
2
Bananas and Plantains
Preharvest foliar
Ground
Airblast, high-
pressure
handwand,
backpack sprayer
41.8% EC
[PR-040005]
0.086
8 for mist
sprayer
4 for all other
application
methods
0.675
21
N/A
Apply before disease symptoms
appear at the onset of the rainy
season. Applications should be
made using orchard oil and an
emulsifier. Do not apply within
100 yards of non-bagged
bananas or directly to non-
bagged bananas.
Celery
Preharvest foliar
Ground or aerial
41.8% EC
[100-617]
[100-737]
45% WP
[100-780]
0.1125
4
0.45
7
14
Foliar
Aerial, ground,
and sprinkler
irrigation
Quilt®
11.7% ai
[100-1178]
0.1138
4
0.45
7
7
87
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Application Type
Application
Equipment
Formulation1
[EPA Reg. No.]
Maximum
Single
Application
Rate
(lb ai/A)
Maximum
Number of
Apps. per
Season
Maximum
Seasonal Rate
(lb ai/A)
Minimum
Application
Interval
(days)
Preharvest
Interval
(PHI)
(days)
Use Directions and Limitations
2
Cereals (Including Wheat, Barley, Triticale, and Rye)
Preharvest foliar
Ground or aerial
41.8% EC
[100-617]
[100-737]
45% WP
[100-780]
0.1125
2
0.167
NS
For barley, oats, ryle, and
triticales, apply to the emerging
flag leaf; but do not apply after
the ligule of the flag leaf
emerges (Feekes growth stage
9). For wheat only, apply until
Ml head emergence (Feekes
growth stage 10.5).
Corn (Including Field Corn, Field Corn Grown for Seed, Sweet Corn, and Popcorn)
Preharvest foliar
Ground or aerial
41.8% EC
[100-617]
[100-737]
45% WP
[100-780]
0.1125
2
0.45
7
14
(sweet corn)
Start treatment when disease
appears and repeated on a 7- to
14-day schedule. Do not apply
to field corn or field corn grown
for seed after silking. Do not
harvest forage from field corn,
field corn grown for seed, and
popcorn within 30 days of
application. Do not harvest
sweet corn forage within 14
days of application.
Preharvest foliar
Ground or aerial
(post silk)
41.8% EC
[LA-020003]
[KS-030002]
[MN-990014]
[NE-990006]
[IL-040004]
0.1125
2
0.45
7
14
(sweet corn)
30
(seed, field,
and
popcorn)
Treatment should be started
when disease appears and
repeated on a 7- to 14-day
schedule. Do not feed livestock
treated forage or fodder and
harvest of sweet corn forage
within 14 days of application
are prohibited.
88
-------
Application Type
Application
Equipment
Formulation1
[EPA Reg. No.]
Maximum
Single
Application
Rate
(lb ai/A)
Maximum
Number of
Apps. per
Season
Maximum
Seasonal Rate
(lb ai/A)
Minimum
Application
Interval
(days)
Preharvest
Interval
(PHI)
(days)
Use Directions and Limitations
2
Between V4 to
after silking
Stratego®
11.4% ai
[264-779]
0.1125
2
0.29
7
30 (forage)
before
silking
Corn Grown for Seed (See Also "Corn")
Preharvest foliar
Ground or aerial,
and sprinkler
irrigation
41.8% EC
[100-617]
[IN-990003]
0.1125
2
0.45
7
30
Treatment should be started
when disease appears and
repeated on a 7- to 14-day
schedule. Making more than
two applications after 50% silk
and feeding livestock treated
forage or fodder are prohibited.
Applications should be made in
a minimum of 10 (ground) or 5
(aerial) gal of water/A.
Preharvest Aerial,
ground, and
sprinkler
irrigation
41.8% EC
0.1125
2
0.45
7
7
When disease first appears.
89
-------
Application Type
Application
Equipment
Formulation1
[EPA Reg. No.]
Maximum
Single
Application
Rate
(lb ai/A)
Maximum
Number of
Apps. per
Season
Maximum
Seasonal Rate
(lb ai/A)
Minimum
Application
Interval
(days)
Preharvest
Interval
(PHI)
(days)
Use Directions and Limitations
2
Grasses Grown for Seed
Preharvest foliar
Ground or aerial
41.8% EC
[100-617]
[100-737]
45% WP
[100-780]
0.225
(0.1125-
bluegrass)
4
0.9
14
20
Use is limited to ID, MN, NE,
OR, and WA. Apply multiple
treatments on a 14- to 21-day
schedule. The feeding of
treated hay is prohibited within
20 days of the last application,
and the grazing of treated areas
is prohibited within 140 days.
Applications should be made in
a minimum of 20 (ground) or
10 (aerial) gal of water/A.
Preharvest foliar
Ground or aerial
41.8% EC
[ID-950012]
[OR-050012]
[WA-950033]
[IN-990003]
[NV-010004]
[MT-030004]
0.225
2
0.45
14
20
Apply just prior to anthesis.
Make second application 7-10
days later. Should be tank
mixed with an appropriate
surfactant. The feeding of
treated hay is prohibited within
20 days of the last application,
and the grazing of treated areas
is prohibited within 140 days.
Applications should be made in
a minimum of 20 (ground) or
10 (aerial) gal of water/A.
90
-------
Application Type
Application
Equipment
Formulation1
[EPA Reg. No.]
Maximum
Single
Application
Rate
(lb ai/A)
Maximum
Number of
Apps. per
Season
Maximum
Seasonal Rate
(lb ai/A)
Minimum
Application
Interval
(days)
Preharvest
Interval
(PHI)
(days)
Use Directions and Limitations
2
Mint
Preharvest foliar
Ground
41.8% EC
[OR-050011]
0.1125
2
0.225
10
90
Apply when plants are 2-4"
high. Make second application
10-14 days later. Applications
should be made in a minimum
of 20 gal of water/A.
Nectarines (See "Stone fruits")
Oats
Preharvest foliar
Ground or aerial
41.8% EC
[100-617]
0.1125
1
0.1125
N/A
40
Highest yields when applied to
the emerging flag leaf; do not
apply after the ligule of the flag
leaf emerges (Feekes growth
stage 8). Applications should
be made in a minimum of 10
(ground) or 5 (aerial) gal of
water/A.
Peaches (See "Stone fruits")
Peanuts
Preharvest foliar
Chemigation or
directed
ground
41.8% EC
[100-617]
45% WP
[100-780]
0.225
2
0.45
14
21
Apply to crown and pegging
zones. Begin applications 45 or
60 days after planting or at the
first appearance of disease;
make second application 14
days or 3-4 weeks later.
Preharvest foliar
Ground or aerial
41.8% EC
[100-617]
41.8% EC
[100-737]
45% WP
[100-780]
0.1125
4
0.45
10
14
Begin applications 35-40 days
after planting and repeat on a
10- to 14-day schedule.
91
-------
Application Type
Application
Equipment
Formulation1
[EPA Reg. No.]
Maximum
Single
Application
Rate
(lb ai/A)
Maximum
Number of
Apps. per
Season
Maximum
Seasonal Rate
(lb ai/A)
Minimum
Application
Interval
(days)
Preharvest
Interval
(PHI)
(days)
Use Directions and Limitations
2
Preharvest foliar
Ground or aerial
11.4% ai
Stratego®
[264-779]
0.1134
6
0.68
14
14
Pecans
Preharvest foliar
Ground or aerial
Stratego®
11.4% ai
[264-779]
Tilt®
41.8% EC
[100-617]
Tilt Bravo SE®
2.9 %ai
[100-1192]
0.081
3
0.24
14
30
Apply on a 14-day schedule
during bud break, prepollination
sprays, or during nut formation
and cover sprays. Use higher
rates when disease pressure is
heavier. Do not apply after
shuck split.
Pineapple Seed Piece Treatment
Postharvest
Cold or hot water
dip
(Seed treatment)
45% WP
[100-780]
0.11251b
ai/500 gal
water
1
0.1125 lb ai/500
gal water
N/A
N/A
Use is limited to Hawaii;
immerse or soak crowns (seed
pieces) for control of disease.
Plantains (See "Bananas and Plantains")
Plums (See "Stone fruits")
92
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Application Type
Application
Equipment
Formulation1
[EPA Reg. No.]
Maximum
Single
Application
Rate
(lb ai/A)
Maximum
Number of
Apps. per
Season
Maximum
Seasonal Rate
(lb ai/A)
Minimum
Application
Interval
(days)
Preharvest
Interval
(PHI)
(days)
Use Directions and Limitations
2
Rice
Preharvest foliar
Aerial
41.8% EC
[100-617]
[100-737]
Stratego® 11.4%
ai
[264-779]
0.2813 or
0.16
2@ 0.1688 lb
ai/A
or
1@ 0.2813 lb
ai/A
0.34
10
35
If 5% of tillers are infected, 2
appls. should be made, one at
lrst internode elongation (up to
2-inch panicle) and one at
swollen boot (10-14 days after
lrst appl. but before the boot
splits and head emerges). If
>10% of tillers are infected, the
higher single application rate
should be made at first
internode elongation. Do not
use in California. In Arkansas,
do not use in areas of the
following counties:
Mississippi, Poinsett, Cross, St.
Francis, and Lee. Do not use in
rice fields where crayfish are
commercially farmed. Do not
drain water from treated rice
fields into ponds used for
commercial catfish farming.
Do not apply to stubble or
ratoon crop rice. Do not use
water drained from treated
fields to irrigate other crops.
Wild Rice
Preharvest foliar
Aerial
41.8% EC
[100-617]
[100-737]
45% WP
[100-780]
0.225
2@ 0.1688 lb
ai/A
or
1@ 0.225 lb
ai/A
0.34
10
NS
Use is limited to Minnesota.
Apply at lower rate at both
booting and heading, OR make
one application at the higher
rate at booting. Do not use
water from treated fields to
93
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Application Type
Application
Equipment
Formulation1
[EPA Reg. No.]
Maximum
Single
Application
Rate
(lb ai/A)
Maximum
Number of
Apps. per
Season
Maximum
Seasonal Rate
(lb ai/A)
Minimum
Application
Interval
(days)
Preharvest
Interval
(PHI)
(days)
Use Directions and Limitations
2
irrigate other crops.
Rye (See "Cereals")
Stone Fruits (Sweet or tart Cherry, Apricots, Nectarines, Peaches, and Plums or Prune)
Preharvest foliar
Ground or aerial
41.8% EC
[100-702]
45% WP
[100-781]
0.1125
2
0.225
10
Two applications may be made
during the period beginning 10-
14 days before harvest through
the day of harvest.
Alternatively, the first
application may be made at
early bloom stage and the
second application may be
made as needed through petal
fall.
Sugarcane Seed Piece Treatment
Postharvest
Cold or hot water
dip
45% WP
[100-780]
0.11251b
ai/500 gal
water
1
0.1125 lb ai/500
gal water
N/A
N/A
Use is limited to Hawaii.
Immerse or soak cut seed pieces
for control of disease.
Sunflower (Breeder's seed)
Foliar spray
41.8% EC
[IL-050002]
[TX-000006]
0.1125
4
0.45
7
N/A
Apply foliar spray, when
disease first appears.
94
-------
Application Type
Formulation1
Maximum
Maximum
Maximum
Minimum
Preharvest
Use Directions and Limitations
Application
[EPA Reg. No.]
Single
Number of
Seasonal Rate
Application
Interval
2
Equipment
Application
Apps. per
(lb ai/A)
Interval
(PHI)
Rate
Season
(days)
(days)
(lb ai/A)
Wheat (See also "Cereals")
Preharvest foliar
41.8% EC
0.1125
1
0.1125
N/A
40
Apply to the emerging flag leaf.
Ground or aerial
[GA-980003]
[IN-980003]
[MI-980001]
[MN-980003]
[MS-980004]
[VA-980003]
[WA-980018]
[AR-030008]
[MO-980003]
[KS-030001]
[TN-030002]
[OH-040002]
[KY-050002]
Do not apply after full head
emergence (Feekes growth
stage 10.5).
The 41.8% EC formulations have been determined to contain 3.6 lb ai/gal of propiconazole based on historical data.
2 Propiconazole may be tank mixed with other fungicides; however labels for EPA Reg. Nos. 100-702 and 100-781 state that tank mixing with Cyprex® may
cause crop injury.
Note: The 41.8% EC [EPA Reg. Nos. 100-617 and 100-737] and the 45% WP [EPA Reg. No. 100-780] are the only products currently registered for use on
rotatable crops. The labels for these formulations state that soybeans may be planted as a double crop following a cereal crop which has been treated with the
product, but soybean hay, forage, and fodder may not be used as any component of animal feed or bedding. The labels specify that any food/feed crops not
listed on the label should not be planted within 105 days of treatment.
95
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APPENDIX A2: Maximum Rates and Applications for Nonfood Uses of Propiconazole Eligible for
Reregistration
Application Type and/or
Timing
Application Equipment
Typical
Formulation
[EPA Reg. No.]
Maximum Application
Rate
Maximum Number of
Applications
Per Crop Cycle
Maximum Annual
Application Rate
(lb ai/A/year)
Minimum
Retreatment
Interval
NONBEARING FRUIT AND NUT TREES
Non-bearing Apple
Foliar
Hose-end and pump-up
sprayer
Alamo® 14.3% ai
[100-741]
Tilt 41.8% EC
[100-617]
0.08 lb ai/A
Not Specified
7.2 lb ai/A/year
14 days
Non-bearing Nectarine, Peach Plum, Cherry
Foliar
Hose-end and pump-up
sprayer
Tilt® 41.8% EC
[100-617]
0.04 lb ai/100 gal
Not Specified
7.2 lb ai/A/year
14 days
Non-bearing Pecan
Non-bearing
Aerial, ground, hose-end and
pump-up sprayer
Tilt® 41.8% EC
[100-617]
0.12 lb ai/100 gal
3
7.2 lb ai/A/yr
14 days
Non-bearing Citrus
June, July, August
Aerial, ground, hose-end and
pump-up sprayer
Orbit®
41.8% EC
[100-702]
Banner GL®
41.8% EC
[100-736]
0.225 lb ai/A
Not Specified
7.2 lb ai/A/yr
14 days
Non-bearing Walnut
Foliar
Spray
Tilt® 41.8% EC
[100-617]
0.08 lb ai/100 gal.
Not Specified
7.2 lb ai/A/yr
14 days
96
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Application Type and/or
Timing
Application Equipment
Typical
Formulation
[EPA Reg. No.]
Maximum Application
Rate
Maximum Number of
Applications
Per Crop Cycle
Maximum Annual
Application Rate
(lb ai/A/year)
Minimum
Retreatment
Interval
TURF AND ORNAMENTALS
Ground Cover
Foliar
Hose-end and pump-up
sprayer
Banner GL®
41.8% EC [100-736]
0.7524 lb ai/A
Not Specified
37 packets
14 days
Lawns, Turf, and Golf Courses
Foliar
Hose-end and pump-up
sprayer
Ground boom sprayer
Banner GL®
41.8% EC
[100-736]
Tilt® 41.8% EC
[100-617]
1.791bai/A
Not Specified
7.2 lb ai/A/yr
14 days
Industrial/Commercial Lawns and Turf
When needed
Ground spray
Banner GL®
41.8% ai
[100-736]
Tilt Bravo® SE
2.9% [100-1192]
0.02 lb/lK sq. ft.
2
Not Specified
14 days
Shade Trees (injection)
Root Injection
Alamo®
14.3% liquid
[100-741]
0.0069 lb ai/DBH
1
Not Specified
Not Applicable
Shade Trees (outdoor spray), Herbaceous Plants, Ornamental Woody Shrubs and Vines
Hose-end and pump-up
sprayer
Banner GL®
41.8% ai
[100-736]
Tilt® 41.8% EC
[100-617]
0.24 lb ai/100 gal
Not Specified
7.2 lb ai/A/yr
Not Specified
Sod Farm Turf
Ground bloom Sprayer
Alamo®
1.79 lb ai/A
Not Specified
7.2 lb ai/A/yr
7
97
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Application Type and/or
Timing
Application Equipment
Typical
Formulation
[EPA Reg. No.]
Maximum Application
Rate
Maximum Number of
Applications
Per Crop Cycle
Maximum Annual
Application Rate
(lb ai/A/year)
Minimum
Retreatment
Interval
14.3% ai liquid
[100-741]
Banner GL 41.8% ai
[100-736]
Tilt® 41.8% EC
[100-617]
Non-bearing Blueberries
Non-bearing
Spray
41.8% EC
[FL-940005]
0.169 lb ai/A
5
0.85 lb ai/A/yr
28 days
(June-October)
Non-bearing Hazelnuts
At emergence
Aerial and ground
41.8% EC
[OR-040003]
0.225 lb ai/A
No more than 32 oz of
Orbit®/A/season
0.90
14 days
Note:
PPZ 1.55% HG [EPA Reg. No. 100-773] and PPZ 1.55% Multi-purpose fimgicide [Reg. No. 100-952] are also used in residential consumer market. These labels have
lower application rates than Alamo/Banner MAXX [EPA Reg No. 100-741],
98
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APPENDIX A3 Propiconazole Antimicrobial Uses Eligible for Reregistration
Use Site
Typical Formulation
[EPA Reg. No.]
%ai
Maximum Application
Rate
Maximum Number of
Applications/
Minimum Retreatment
Interval
Use Directions and
Limitations
Application Method from
Labels
Antimicrobial Uses -Material Preservative
Adhesives, coatings, caulks,
sealants, and inks
50% SL
[43813-37]
9.7% ai
[43813-19]
1.213% ai by weight of
material
NS
For Commercial or Industrial
Use Only
7% Liquid
Concentrate
[5383-114]
0.125-5.0%
NS
For Commerical or Industrial
Use Only
8% Liquid
[1448-394]
0.6 -10 %
NS
23.6% EC
[43813-16]
0.2 - 5% based on total
weight of material
NS
For Commercial or Industrial
Use Only
Do not use on products that
will contact food
Industrial Coatings, Industrial
Specialty Industrial Products
50% SL
[43813-37]
0.1-2.4% based on total
weight of material
NS
For Commercial or Industrial
Use Only
7% Liquid
Concentrate
[5383-114]
0.125-5%
For Commercial or Industrial
Use Only
Material Preservative for
Paints and Stains
10% Liquid
Concentrate
[5383-114]
0.125 % ai by weight of
material to be preserved
For Commercial or Industrial
Use Only
Leather Processing, Material
Preservative for Leather
Finishing Pastes etc
4.5% ai
[71406-1]
[70227-6]
0.05 to 0.4% by weight of
tanned leather; 0.01 to
0.25% by weight of leather
finishing pastes, fatliquors,
or finishes
NS
For Commercial or Industrial
Use Only
Add to tanning solution or
finishing solution OR
Add to leather finishing pastes,
fatliquors, or finish
Metal working/Cutting Fluids
23.6% EC
[43813-16]
50 -700 ppm ai in diluted
fluid
NS
For Commercial or Industrial
Use Only
Added to Metalworking Fluids
using Liquid Pump or Liquid
Pour
50% SL
[43813-37]
50-700 ppm ai in diluted
fluid
Not Specified
For Commercial or Industrial
Use Only
99
-------
Use Site
Typical Formulation
[EPA Reg. No.]
%ai
Maximum Application
Rate
Maximum Number of
Applications/
Minimum Retreatment
Interval
Use Directions and
Limitations
Application Method from
Labels
Textiles/Canvas
7%ai
[5383-114]
0.5-2.5
Not Specified
Not for use on carpet fibers,
home fiirnishings (except
shower curtains), or apparel
50% SL[
43813-37]
0.28% ai by weight of
material to be preserved
Not Specified
23.6% EC
[43813-16]
2000 ppm ai in treatment
solution
Not Specified
Dye Incorporation, Pad,
Exhaust, or Spray Application
50% SL
[43813-37]
2000 ppm in treatment
solution (0.4% product)
Not Specified
Dye Incorporation, Pad,
Exhaust, or Spray Application
Antimicrobial Uses - Wood Preservative
Wood in
Commercial/Industrial Water
Cooling Systems
23.6% EC
[43813-16]
0.5 - 1.1% ai solution (0.23
- 0.46 lbs ai/1000 sq. ft
wood
When Needed, Repeat
Shock Treatement
every 4-6 months
Not Specified
High volume spray
Mushroom Houses-Empty
Premises/ Equipment
23.6% EC
[43813-15]
[43813-16]
0.31 lb/25 gal
0.06 lb/1000 sq. ft.
0.0125 lb ai/gal; 1 gal/200
sq ft wood
13 week application
interval
For spray treatment, apply 25
gallons of treatment solution
per 5000 square feet of
surface
For dip treatment, submerge
trays or boards for no more
than 30 seconds
Spray and dip tank
Wood Protection Treatment
to Buildings (Indoor)
23.6% EC
[43813-16]
9.7% SL
[43813-19]
[75506-3]
20% ai [70227-4]
50% ai
[43813-21]
[43813-37]
301 cu.m (L)
Typically 1
Not Specified
Conventional or electrostatic
spray and dip tank
Wood Protection Treatment
to Buildings (Outdoor)
0.3532 lb ai/iK sq. ft.
Typically 1
Not Specified
Conventional or electrostatic
spray and dip tank
Wood Protection Treatment
to Forest Products (Seasoned)
6.8 lb/90 gal
Typically 1
Not Specified
Pressure treatment (double
vacuum, full-cell or modified
full-cell) and brush applied
Wood Protection Treatment
to Forest Products
(Unseasoned)
41.7 lb/90 gal
Typically 1
Not Specified
100
-------
Use Site
Typical Formulation
[EPA Reg. No.]
%ai
Maximum Application
Rate
Maximum Number of
Applications/
Minimum Retreatment
Interval
Use Directions and
Limitations
Application Method from
Labels
Non-pressure Treatment of Wood & Wood Products
Anti-Sapstain
1% Liquid Ready-
to-Use
[1448-414]
0.02% ai solution (0.5 to
2.0 gallons per 100 gallons
of water)
Not Specified
Not Specified
Immersion, Dip treatment,
Conventional Spray,
Electrostatic Spray
3% Liquid
[1022-585]
0.06 % ai solution
(1 gallon per 50 to 75
gallons of dip vat solution)
Not Specified
For Commerical or Industrial
Use Only
Immersion, Dip Treatment
3.5% Liquid
[60061-112]
For high-pressure spray
application, mix 1 gallon
per 2 to 500 gallons water
For dip application, mix 1
gallon per 20 to 1,000
gallons water
Not Specified
For Commercial or Industrial
Use Only
Immersion, Dip Treatment,
High-pressure Application
4.5% Liquid
[71406-1]
[70227-6]
[60061-114]
Deposit rate of 0-20 ug
ai/cm wood surface
Not Specified
For Commercial or Industrial
Use Only
Bulk Dip Tanks, Conventional
Spray Systems, Low volume
spray systems
5% Liquid
[72616-1]
[60061-107]
0.1-0.2% ai solution
(1 gallon with 25-300
gallons of water)
Not Specified
For Commercial or Industrial
Use Only
Dip Tank, Immersion,
Conventional Spray, High-
Pressure Spray
50% SL
[43813-37]
0.5-1.0% ai solution
Not Specified
For Commercial or Industrial
Use Only
Immersion, roller coater,
flood, spray, brush treatment
Anti-Saptain
7% Liquid
Concentrate
[5383-114]
0.5 to 5% ai solution
Not Specified
For Comemrcial or Industrial
Use Only
Dip Tank, Immersion,
Conventional Spray, High-
Pressure Spray
8% Liquid
Concentrate
[1448-394]
0.5-5% ai solution
Not Specified
For Commercial or Industrial
Use Only
Dip Tanks, Conventional
Spray Systems
9.7% Liquid
Concentrate
[43813-19]
0.5 -1% ai solution
Not Specified
Not Specified
Immersion, Roller Coater,
Flood Spray, Brush
10% Liquid
0.04 to 1.7% ai solution
Not Specified
For Commercial or Industrial
Dip Tanks, Conventional
101
-------
Use Site
Typical Formulation
[EPA Reg. No.]
%ai
Maximum Application
Rate
Maximum Number of
Applications/
Minimum Retreatment
Interval
Use Directions and
Limitations
Application Method from
Labels
Concentrate
[60061-102]
(1 gallon with 50 to 2000
gallons water)
Use Only
Spray Systems
Anti-Sapstain for fresh sawn
lumber
20%Liquid
Concentrate
[70227-4]
0.05 - 0.5% ai solution
Not Specified
Not Specified
Dip Tank, Spray Box
Wood preservative/Decay
Control
9.7% Liquid
Concentrate
[43813-19]
[62190-17]
0.5%- 5% ai solution
Not Specified
For Commercial or Industrial
Use Only
Immersion, Roller Coater,
Flood Spray, Brush
onventional Spray,
Electrostatic Spray
0. l%Liquid Ready-
to-Use
[60061-109]
0.1% Ready-to Use, 5 to 10
gallons per 1000 board feet
for diptank; 1 gallon per
200 square feet for brush
application
Not Specified
For Commercial or Industrial
Use Only
Diptank or Brush Application
[60061-115]
0.997% ai
Dilute one part product
with 4 parts petroleum
solvent
Not Specified
Dilute one part product with
1.5 to 4 parts petroleum
solvent
Immersion, pressure treatment
23.6% EC
[43813-16]
0.5 - 1 % ai solution
Not Specified
For Cmmercial or Industrial
Use Only
Do not use on wood that will
contact food
Immersion, roller coating, or
flood coating
Wood Preservative
50% SL
[43813-37]
0.5-1.0% ai solution
Not Specified
For Commerical or Industrial
Use Only
Immersion, roller coater,
flood, spray, brush, or pressure
treatment
Pressure Treatment of Wood
Wood preservative
0.4% ai
[62190-12]
0.5 to 7% aqueous solution
by weight
Not Specified
For Commercial or Industrial
Use Only
Use only in vacuum pressure
impregnation systems
Wood Preservative -
machined and manufactured
wood products
0.5% Liquid Ready-
to Use
[75101-1]
3
30 L/meter
Not Specified
Wood must be clean and dry
before treatment.
Pressure treatment (double
vacuum process)
0.997% ai Liquid
[60061-115]
0.5 % ai solution
Not Specified
Dilute product with
petroleum solvent
Immersion, pressure treatment
102
-------
Use Site
Typical Formulation
[EPA Reg. No.]
%ai
Maximum Application
Rate
Maximum Number of
Applications/
Minimum Retreatment
Interval
Use Directions and
Limitations
Application Method from
Labels
Wood preservative
50% SL
[43813-37]
0.5-1.0% ai solution
Not Specified
For Commercial or Industrial
Use Only
Double vacuum, lull cell, or
modified lull cell pressure
treatment
103
-------
APPENDIX B: Data Supporting Guideline Requirements for the Reregistration of Propiconazole
I
Requirement
Use
Pattern
MRU) Citation(s)
New
Guideline
Number
Old
Guideline
Number
Study Title
PRODUCT CHEMISTRY
830.1550
61-1
Product Identity and Composition
All
40583701, 43764401
830.1600
61-2 A
Start. Mat. & Mnfg. Process
All
40583701, 43420701
830.1670
61-2B
Formation of Impurities
All
40583701, 43764401
830.1700
62-1
Preliminary Analysis
All
40583702, 43764402
830.1750
62-2
Certification of limits
All
40583702, 43764401
830.1800
62-3
Analytical Method
All
40583702, 43764402
830.6302
63-2
Color
All
40583703, 42030201,
43698701
830.6303
63-3
Physical State
All
40583703, 42030201,
43698701
830.6304
63-4
Odor
All
40583703, 42030201,
43698701
830.7220
63-6
Boiling Point
All
40583703, 42030201,
43698701
830.7300
63-7
Density
All
40583703, 42030201,
43698701
830.7840
830.7860
63-8
Solubility
All
40583703, 42030201
830.7950
63-9
Vapor Pressure
All
40583703, 42030201
830.7370
63-10
Dissociation Constant
All
40583703, 42030201,
43698701
830.7550
63-11
Octanol/Water Partition Coefficient
All
42030201, 43698701
830.7000
63-12
PH
All
42030201, 43698701
830.6313
63-13
Stability
All
43698701, 00067961
ECOLOGICAL EFFECTS
850.2100
71-1
Avian Acute Oral Toxicity
00079689, 00067926
104
-------
I
Requirement
Use
Pattern
MRID Citation(s)
New
Guideline
Number
Old
Guideline
Number
Study Title
850.2200
71-2 A
Avian Dietary Toxicity - Quail
00072210, 00133366
850.2200
71-2B
Avian Dietary Toxicity - Duck
00067927, 00072210,
00133367
850.2300
71-4 A
Avian Reproduction - Quail
00133369
850.1075
72-1A
Fish Toxicity Bluegill
0067922
850.1075
72-IB
Fish Toxicity Bluegill -TEP
00132922, 00072209
850.1075
72-1C
Fish Toxicity Rainbow Trout
00067921 (0072209),
0067923, 00132926
None
72-3D
Fish Toxicity Rainbow Trout TEP
00132927
850.1010
72-2A
Invertebrate Toxicity
00067925, 00244273
850.1010
72-2B
Invertebrate Toxicity - TEP
00132932, 00072209
850.1075
72-3A
Estuarine/Marine Toxicity - Fish
00132921
850.1025
72-3B
Estuarine/Marine Toxicity - Mollusk
00260201
850.1035
850.1045
72-3C
Estuarine/Marine Toxicity - Shrimp
00260201
None
72-3D
Estuarine/marine Fish Acute Toxicity
Test (TEP)
None
72-3E
Estuarine/marine Mollusk (Oyster)
Acute Toxicity Test (Shell Deposition)
(TEP)
0013
88^2933, 0072209
None
72-3F
Estuarine/marine Mysid (Shrimp) Acute
Toxicity Test (TEP)
00132934, 0072209
850.1400
72-4A
Fish- Early Life Stage
00072210
850.1300
850.1350
72-4B
Estuarine/Marine Invertebrate Life
Cycle
Data Gap
850.4225
123-1A
Seed Germ./ Seedling Emergence
41673203
850.4250
123-1B
Vegetative Vigor
41673201
105
-------
I
Requirement
Use
Pattern
MRID Citation(s)
New
Guideline
Number
Old
Guideline
Number
Study Title
850.4400
123-2
Aquatic Plant Growth
00132937, 00132938,
00132939, 00133362
TOXICOLC
>GY
870.1100
81-1
Acute Oral Toxicity-Rat
00058591
870.1200
81-2
Acute Dermal Toxicity-Rabbit/Rat
00058596
870.1300
81-3
Acute Inhalation Toxicity-Rat
41594801
870.2400
81-4
Primary Eye Irritation-Rabbit
00058597
870.2500
81-5
Primary Skin Irritation
00058598
870.2600
81-6
Dermal Sensitization
00058600
870.6200
81-8
Acute Neurotoxicity Screen - Rats
46604601
870.3100
82-1A
90-Day Feeding - Rodent
00058606, 42050501,
42050502, 45215801
870.3150
82-1B
90-Day Feeding - Non-rodent
00058607
870.3200
82-2
21-Day Dermal - Rabbit/Rat
00116591
870.4100
83-1B
Chronic Feeding Toxicity - Non-Rodent
00151515
870.4200
83-2 A
Oncogenicity - Rat
00129918
870.4200
83-2B
Oncogenicity - Mouse
00129570, 44381401
870.3700
83-3A
Developmental Toxicity - Rat
40425001
870.3700
83-3B
Developmental Toxicity - Rabbit
40425004
870.3800
83-4
2-Generation Reproduction - Rat
00151514
870.4100
83-1A
Chronic Dietary - Rodent
00129918
870.4100
83-1B
Chronic Dietary - Non-rodent
00151515
870.5300
84-2
In Vitro Cell Transformation
00133349
870.5385
84-2B
Structural Chromosomal Aberration
00058603
870.5450
84-2
Rodent Dominant Lethal Assay
00058602
106
-------
I
Requirement
Use
Pattern
MRID Citation(s)
New
Guideline
Number
Old
Guideline
Number
Study Title
870.5550
84-2
Unscheduled DNA Synthesis in
Mammalian Cells
00133347, 00133348
870.5575
84-2
Mitotic Gene Conversion in
Saccharomyces Cerevisiae
00133343
870.7485
85-1
General Metabolism
42403901, 41326701,
00074506, 00074507,
00164795
OCCUPAT]
ONAL/RESIDENTIAL EXPOSURE
875.1100
231
Estimation of Dermal Exposure,
Outdoor Sites
45524304, 45469501,
ORTF# OMA002,
ORTF# OMA004, New
Data Requirement (Paint
Use)
875.1200
233
Estimation of Dermal Exposure, Indoor
Sites
45524304, ORTF#
OMA004, New Data
Requirement (Paint,
Wood Preservative
Uses)
875.1300
232
Estimation of Inhalation Exposure,
Outdoor Sites
45524304, 45469502,
New Data Requirement
(Paint Use)
875.1400
234
Estimation of Inhalation Exposure,
Indoor Sites
45524304, 46513901,
New Data Requirement
(Paint, Wood
Preservative Uses)
875.1200
132-1A
Foliar (Dislodgeable) Residue
Dissipation
00133390, 42564003,
44959701, 44959702,
45288601
107
-------
I
Requirement
Use
Pattern
MRU) Citation(s)
New
Guideline
Number
Old
Guideline
Number
Study Title
ENVIRONMENTAL FAT
£
835.2120
161-1
Hydrolysis
0067901, 0067911,
133409, 93194052
835.2240
161-2
Photodegradation - Water
41811901, 0067911,
133409
835.2410
161-3
Photodegradation - Soil
41811902, 0067911,
133409
835.4100
162-1
Aerobic Soil Metabolism
00129912, 00129914,
00133375
835.4400
162-3
Anaerobic Aquatic Metabolism
42415702
835.4300
162-4
Aerobic Aquatic Metabolism
42347901
835.1240
163-1
Leaching/Adsorption/Desorption
Data Gap (MRIDs
41727001, 44701801 are
both supplemental)
835.6100
164-1
Terrestrial Field Dissipation
00155642, 00159691,
45528702, 45528703
835.6200
164-2
Aquatic Field Dissipation
452560501, 452560502
RESIDUE CHEMISTRY
860.1300
171-4A
Nature of Residue - Plants
A,B
00074496, 00074498,
00074499, 00074500,
00074501, 00074502,
00129915 ,00155645,
44049601, 44381402,
93194062
108
-------
I
Requirement
Use
Pattern
MRID Citation(s)
New
Guideline
Number
Old
Guideline
Number
Study Title
860.1300
171-4B
Nature of Residue - Livestock
A,B
00067905, 00074503,
00074504,41823301,
41823302,41823304,
42564006, 42983001,
93194085
860.1340
171-4C
Residue Analytical Method - Plants
A,B
00137150, 40154501,
40180701, 40692203,
40692204, 40692206,
40783306, 41063801,
41063802, 41486801,
41823305, 42061301,
42182901, 42564005,
42605801, 42634101,
43424601, 43434201,
43825401,44411201,
44411206,44411207,
44411208, 93194064
860.1340
171-4D
Residue Analytical Method - Animals
A,B
40150701,40154501,
40180702, 41823304,
44411204, 93194067
860.1380
171-4E
Storage Stability
A,B
00074510, 00074511,
00133385, 40692201,
41063801, 41063802,
41486802, 42605801,
43314201,43825402,
44411205, 93194068,
40150701 ,42983001
860.1650
171-13
Analytical Reference Standards
A,B
Data Gap
860.1480
171-4J
Magnitude of Residues - Meat/Milk/Pou
[try/Egg
109
-------
I
Requirement
Use
Pattern
MRID Citation(s)
New
Guideline
Number
Old
Guideline
Number
Study Title
Milk and the Fat, Meat, and Meat
Byproducts of Cattle, Goats, Hogs,
Horses, and Sheep
A,B
00137861,40150701,
93194070
Eggs and the Fat, Meat, and Meat
Byproducts of Poultry
A,B
00137861,40150701,
93194070
860.1500
171-4K
Crop Field Trials (Stone Fruits Group)
Apricots
A,B
41063802
Cherries
A,B
43655609
Nectarines
A,B
41063802
Peaches
A,B
41063802
Plums
A,B
41063802
Prunes, fresh
A,B
41063802
860.1500
171-4K
Crop Field Trials (Tree Nuts Group)
Pecans
A,B
00074495 ,00074508,
00074509,00153327
860.1500
171-4K
Crop Field Trials (Cerial Grains Group)
Barley, grain
A,B
93194072
Corn, field, grain and aspirated
grain fractions
A,B
40783303, 42564004,
42564005
Corn, sweet (kernels plus cobs
with husks removed)
A,B
40783303, 42564004,
42564005
Oats, grain
A,B
42182901,43314202
Rice, grain
A,B
00137861, 42915601,
44411208, 93194075
Wheat, grain and aspirated
grain fractions
A,B
44411206,44411207,
93194072
Wild rice
A,B
41063801,42511401
860.1500
171-4K
Crop Field Trials (Fodder, Forage, Hay, and Straw of Cereal Grains Group)
110
-------
I
Requirement
Use
Pattern
MRID Citation(s)
New
Guideline
Number
Old
Guideline
Number
Study Title
Barley, hay and straw
A,B
93194072
Corn, field, forage and stover
A,B
40783303, 42564004,
42564005
Corn, sweet, forage and stover
A,B
40783303, 42564004,
42564005
Oats, forage, hay, and straw
A,B
42182901,43314202
Rice, straw
A,B
00137861,44411208,
93194075
Wheat, forage, hay, and straw
A,B
44411206,44411207,
93194072
860.1500
171-4K
Crop Field Trials (Grass Forage, Fodder, and Hay Group)
Grass, seed screenings, forage,
hay, and straw
A,B
40890701, 41823305,
42634101, 42634102,
93194073
860.1500
171-4K
Crop Field Trials (Miscellaneous Commodities)
Bananas
A,B
00137150, 93194071
Mint
A,B
42061301, 43424601
Mushrooms
A,B
43434201
Peanut, nutmeat and hay
A,B
40692201
Pineapple
A,B
40783305
Sugarcane
A,B
44142401, 93194077
860.1520
171-4L
Magnitude of Residue in Processed Fooc
/feed
Corn, field
A,B
40783303, 42564005
Mint
A,B
42061301, 43424601
Oat
A,B
42182901
Peanut
A,B
40692201, 42605801
Pineapple
A,B
40783305, Data Gap
Ill
-------
I
Requirement
Use
Pattern
MRU) Citation(s)
New
Guideline
Number
Old
Guideline
Number
Study Title
Plum
A,B
41063802
Rice
A,B
00137861, 42915601,
93194079
Wheat
A,B
44411206,44411207,
44757208, 93194080
835.1850
165-1
Confined Rotational Crop
A,B
00074498, 00129915,
00138266, 00155644,
00155645, 00164802,
41102001
860.1950
165-4
Bioaccumulation in Fish
A,B
44411206
OTHER
Non-
Guideline
Rat developmental Toxicicty
40425002
Non-
Guideline
Tumor Promotion - rat 2000 ppm
dietary up to 8 weeks
Non-
Guideline
Mechanistic studies:Hepatic
Biochemical Parameters - Male CD-I
mice
0015
4521
1517
5803
Non-
Guideline
Mechanistic studies:Hepatocellular
Proliferation - Mouse
Non-
Guideline
Catfish Acute Toxicity
4521
5$Pfe2930, 00067924,
00244273
112
-------
Appendix C: Bibliography of Studies Considered in the Propiconazole RED
GUIDE TO APPENDIX C
CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies considered relevant by EPA in arriving at the
positions and conclusions stated elsewhere in the Reregistration Eligibility Document. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies in support of past regulatory decisions.
Selections from other sources including the published literature, in those instances where they have been considered, are included.
UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of published materials, this corresponds
closely to an article. In the case of unpublished materials submitted to the Agency, the Agency has sought to identify documents at a
level parallel to the published article from within the typically larger volumes in which they were submitted. The resulting "studies"
generally have a distinct title (or at least a single subject), can stand alone for purposes of review and can be described with a
conventional bibliographic citation. The Agency has also attempted to unite basic documents and commentaries upon them, treating
them as a single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by Master Record Identifier, or "MRID
number". This number is unique to the citation, and should be used whenever a specific reference is required. It is not related to the
six-digit "Accession Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4) below for further
explanation). In a few cases, entries added to the bibliography late in the review may be preceded by a nine character temporary
identifier. These entries are listed after all MRID entries. This temporary identifying number is also to be used whenever specific
reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of a citation containing standard
elements followed, in the case of material submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute (ANSI), expanded to provide for certain special
needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to show a personal author. When no
individual was identified, the Agency has shown an identifiable laboratory or testing facility as the author. When no author or
laboratory could be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the date is followed by a question mark,
-------
the bibliographer has deduced the date from the evidence contained in the document. When the date appears as (19??), the
Agency was unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or enhance a document title. Any such
editorial insertions are contained between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing parentheses include (in addition to any self-
explanatory text) the following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears immediately following the word "received."
(2) Administrative number. The next element immediately following the word "under" is the registration number,
experimental use permit number, petition number, or other administrative number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing parentheses identifies the EPA
accession number of the volume in which the original submission of the study appears. The six-digit accession
number follows the symbol "CDL," which stands for "Company Data Library." This accession number is in turn
followed by an alphabetic suffix which shows the relative position of the study within the volume.
114
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Product Chemistry
00067961 Heinrichs, L. (1981) Complete Analysis of CGA-64250 Technical by Liquid
Chromatography, Gas Chromatography, and Thin Layer Chromatography.
Method no. PA-227R dated Jan 20, 1981. (Unpublished study received Jan 28,
1981 under 100-618; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:244267-B)
40583701 Brown, R.; Lail, L. (1988) Product Chemistry: CGA-64250 Technical: Study No.
PC-87-026. Unpublished compilation prepared by Ciba- Geigy Corp. 81 p.
40583702 Brown, R.; Lail, L. (1988) Product Chemistry: CGA-64250 Technical: Study No.
PC-87-026. Unpublished compilation prepared by Ciba- Geigy Corp. 98 p.
40583703 Brown, R.; Lail, L. (1988) Product Chemistry: CGA-64250 Technical: Study No.
PC-87-026. Unpublished compilation prepared by Ciba- Geigy Corp. 81 p.
42030201 Lail, L. (1991) Product Chemistry of CGA-64250 Technical: Lab Proj- ect
Number: PC-91-024. Unpublished study prepared by Ciba-Geigy Corp. 5 p.
43420701 McCain, P. (1994) CGA-64250 Technical: Supplement to Product Chemistry:
(Manufacturing Process). Unpublished study prepared by Ciba-Geigy Corp. 70 p.
43698701 McCain, P. (1994) CGA-64250 Technical: Supplement to Product Chemistry:
Lab Project Number: AG-87/22P. Unpublished study prepared by Ciba-Geigy
Corp. 12 p.
43764401 McCain, P. (1995) CGA-64250 Technical: Product Chemistry: Supplement: Lab
Project Number: Z:\CC-DOC\PRODCHEM\405-A.DOC. Unpublished study
prepared by Ciba-Geigy Corp. 14 p.
43764402 McCain, P. (1995) CGA-64250 Technical: Product Chemistry: (Analysis and
Certification of Product Ingredients): Lab Project Number: Z:\CC-
DOC\PRODCHEM\40583702.DOC: 13-02-1995. Unpublished study prepared
by Ciba-Geigy Corp. 68 p.
Ecological Effects
00067921
(00072209,
00244273)
00067922
00067923
Ballantine, L.G.; Nixon, W.B. (1980) Environmental Safety of Technical CGA-
64250 to Representative Wildlife Species: Report No. ABR-80049. Summary of
studies 244273-B through 244273-1. (Unpublished study received Jan 28, 1981
under 100-618; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:244273-
A)
Thompson, C.M.; Griffen, J.; Cranor, W. (1980) Acute Toxicity of CGA-64250 to
Bluegill Sunfish (Lepomis macrochirus)\ Static Acute Bioassay Report # 26031.
(Unpublished study received Jan 28, 1981 under 100-618; prepared by Analytical
Bio Chemistry Laboratories, Inc., submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:244273-B)
Thompson, C.M.; Griffen, J.; Cranor, W. (1980) Acute Toxicity of CGA-64250 to
Rainbow Trout (Salmo gairdneri): Static Acute Bioassay Report # 26038.
115
-------
00067925
00067926
00067927
00079689
00084008
(00072210)
00132921
00132922
00132924
00132926
(Unpublished study received Jan 28, 1981 under 100-618; prepared by Analytical
Bio Chemistry Laboratories, Inc., submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:244273-C)
Forbis, A.D.; Boudreau, P.; Cranor, W. (1980) Acute Toxicity of CGA-64250 to
Daphnia magna: Static Acute Bioassay Report # 26040. (Unpublished study
received Jan 28, 1981 under 100-618; prepared by Analytical Bio Chemistry
Laboratories, Inc., submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:244273-E)
Fink, R; Beavers, J.B.; Joiner, G.; et al. (1980) Final Report: Acute Oral LD50--
Mallard Duck: Project No. 108-194. (Unpublished study received Jan 28, 1981
under 100-618; prepared by Wildlife International, Ltd. and Washington College,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:244273-G)
Fink, R; Beavers, J.B.; Joiner, G.; et al. (1980) Final Report: Eight-day Dietary
LC50—Mallard Duck: Project No. 108-192. (Unpublished study received Jan 28,
1981 under 100-618; prepared by Wildlife International, Ltd. and Washington
College, submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:244273-I)
Fink, R; Beavers, J.B.; Joiner, G.; et al. (1980) Final Report: Acute Oral LD50--
Bobwhite Quail: Project No. 108-193. (Unpublished study received Jan 28, 1981
under 100-618; prepared by Wildlife International, Ltd. and Washington College,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:244273-F)
Reinert, J.C. (1980) Estimating the Maximum Concentration of Pesticides in the
Environment as a Consequence of Specific Events. (U.S. Environmental
Protection Agency, Office of Pesticide Pro- grams, Hazard Evaluation Div.,
Environmental Fate Branch; unpublished study; CDL:246167-B)
Ward, G. (1981) Acute Toxicity of CGA-64250 to Spot...: Report No. BP-81-7-
123R. Rev. (Unpublished study received Dec 12, 1983 under 100-617; prepared
by EG & G Bionomics, submitted by Ciba-Geigy Corp., Greensboro, NC;
CDL:072209-C)
Hitz, H.; Kurmann, F.; Mendezu, C.; et al. (1981) Report on the Acute Toxicity of
CGA 64250 to Bluegill...: Test No. 81 03 03. (Unpublished study received Dec
12, 1983 under 100-617; prepared by Ciba-Geigy Ltd., Switz., submitted by Ciba-
Geigy Corp., Greensboro, NC; CDL:072209-D)
Ward, G. (1983) Acute Toxicity of Tilt 3.6Eto Spot...: Report No. BP-83-4-48.
(Unpublished study received Dec 12, 1983 under 100-617; prepared by EG & G
Bionomics, submitted by Ciba-Geigy Corp., Greensboro, NC; CDL:072209-F)
Hitz, H; Kurmann, F.; Mendezu, C.; et al. (1981) Report on the Test for Acute
Toxicity of CGA 64 250 to Rainbow Trout: Project No. 81 03 01. (Unpublished
study received Dec 12, 1983 under 100-617; prepared by Ciba-Geigy Ltd., Switz.,
submitted by Ciba-Geigy Corp., Greensboro, NC; CDL:072209-H)
00132927
Buchanan, J.; Pell, I. (1980) The Acute Toxicity of 2 Formulations of CGA
116
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64,250 to the Carp and the Rainbow Trout: CBG 276/80961. (Unpublished study
received Dec 12, 1983 under 100-617; prepared by Huntingdon Research Centre,
Eng., submitted by Ciba-Geigy Corp., Greensboro, NC; CDL:072209-I)
00132932 LeBlanc, G.; Surprenant, D. (1983) Acute Toxicity of Tilt 3.6E to the Water Flea.
Report #BW-83-2-1367. (Unpublished study received Dec 12, 1983 under 100-
617; prepared by EG & G, Bionomics, submitted by Ciba-Geigy Corp.,
Greensboro, NC; CDL: 072209-N)
00132933 Ward, G. (1983) Acute Toxicity of Tilt 3.6Eto Eastern Oysters ...: Report No.
BP-83-3-42. (Unpublished study received Dec 12, 1983 under 100-617; prepared
by EG & G Bionomics, submitted by Ciba- Geigy Corp., Greensboro, NC;
CDL:072209-0)
00132934 Ward, G. (1983) Acute Toxicity of Tilt 3.6EtoMysid Shrimp ...: Report No. BP-
83-4-50. (Unpublished study received Dec 12, 1983 under 100-617; prepared by
EG & G Bionomics, submitted by Ciba-Geigy Corp., Greensboro, NC;
CDL:072209-P)
00132937 Hollister, T. (1981) The Effect of CGA-64250 to the Freshwater Alga
Selenastrum capricornutum: Report No. BP-81-7-129-R. Rev. (Un- published
study received Dec 12, 1983 under 100-617; prepared by EG & G Bionomics,
submitted by Ciba-Geigy Corp., Greensboro, NC; CDL:072209-S)
00132938 Hollister, T. (1981) The Effect of CGA-64250 to the Freshwater Diatom Navicula
seminulum\ Report No. BP-81-8-134R. Rev. (Unpublished study received Dec 12,
1983 under 100-617; prepared by EG & G Bionomics, submitted by Ciba-Geigy
Corp., Greensboro, NC; CDL:072209-T)
00132939 Hollister, T. (1981) The Effect of CGA-64250 to the Marine Alga Skeletonema
costatum: Report No. BP-81-8-136-R. Rev. (Unpublished study received Dec 12,
1983 under 100-617; prepared by EG & G Bionomics, submitted by Ciba-Geigy
Corp., Greensboro, NC; CDL:072209-U)
00133362 Hollister, T. (1981) The Effect of CGA-64250 to the Blue-green Alga. Project
No. R26; Report No. BP-81-8-137- R. Rev. (Unpublished study received Dec 12,
1983 under 100- 617; prepared by EG&G Bionomics, submitted by Ciba-Geigy
Corp., Greensboro, NC; CDL:072210-A)
00133366 Ullmann, L. (1978) Report on 8-day-feeding Toxicity in the Adult Japanese Quail
of Technical CGA 64250: Project No. 785254. (Un- published study received Dec
12, 1983 under 100-617; prepared by Ciba-Geigy Ltd., Switz., submitted by Ciba-
Geigy Corp., Greensboro, NC; CDL:072210-I)
00133367 Ullmann, L. (1978) Report on 8-day-feeding Toxicity in the 3-day Old Peking
Duck of Technical CGA 64250: Project # 785255. (Un- published study received
Dec 12, 1983 under 100-617; prepared by Ciba-Geigy Ltd., Switz., submitted by
Ciba-Geigy Corp., Greensboro, NC; CDL:072210-J)
00133369 Fink, R; Beavers, J.; Joiner, G.; et al. (1982) One-generation Reproduction—
117
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00155960
(00260201)
41673201
41673203
Toxicology
00058591
00058596
00058597
00058598
00058600
00058602
00058603
Bobwhite Quail: CGA 64250 Technical: Project No. 108-202. Final rept.
(Unpublished study received Dec 12, 1983 under 100-617; prepared by Wildlife
International Ltd., submitted by Ciba-Geigy Corp., Greensboro, NC;
CDL:072210-M)
Ciba-Geigy Corp. (1985) Additional Information on the Ecological Effects of Tilt
Used on Rice. Unpublished compilation. 2360 p.
Maggio, R. (1990) Tier 2 Vegetative Vigor Nontarget Phytotoxicity Study Using
Propiconazole: Lab Project Number: LR90-418. Unpublished study prepared by
Ciba-Geigy Corp. 141 p.
Maggio, R. (1990) Tier 2 Seedling Emergence Nontarget Phytotoxicity Study
Using Propiconazole: Lab Project Number: LR90-420. Unpublished study
prepared by Ciba-Geigy Corp. 149 p.
Bathe, R. (1978) Report on Acute Oral LD50 in the Rat of Technical CGA 64250:
Project No. 785244. (Unpublished study received Jan 28, 1981 under 100-618;
prepared by Ciba-Geigy Ltd., Switzerland, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL: 244271-B)
Bathe, R. (1979) Report on Acute Dermal LD50 in the Rat of Technical CGA
64250: Project No. 785245. (Unpublished study received Jan 28, 1981 under 100-
618; prepared by Ciba-Geigy Ltd., Switzerland, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:244271-G)
Sachsse, K.; Ullmann, L. (1978) Eye Irritation in the Rabbit after Single
Application of Technical CGA 64250: Project No. 785248. (Unpublished study
received Jan 28, 1981 under 100-618; prepared by Ciba-Geigy Ltd., Switzerland,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:244271-H)
Sachsse, K.; Ullmann, L. (1978) Skin Irritation in the Rabbit after Single
Application of Technical CGA 64250: Project No. 785249. (Unpublished study
received Jan 28, 1981 under 100-618; prepared by Ciba-Geigy Ltd., Switzerland,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:244271-I)
Ullmann, L. (1979) Report on Skin Sensitizing (Contact Allergenic) Effect in
Guinea Pigs of Technical CGA 64250: Project No. 785250. (Unpublished study
received Jan 28, 1981 under 100- 618; prepared by Ciba-Geigy Ltd., Switzerland,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:244271-K)
Hool, G. (1979) Dominant Lethal Study: CGA 64 250: Mouse: No. of
Experiment: 790034. (Unpublished study received Jan 28, 1981 under 100-618;
prepared by Ciba-Geigy Ltd., Switzerland, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:244271-M)
Hool, G.; Langauer, M. (1979) Nucleus Anomaly Test in Somatic Interphase
Nuclei: CGA 64 250: Chinese Hamster: No. of Experiment: 79-0805.
118
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(Unpublished study received Jan 28, 1981 under 100- 618; prepared by Ciba-
Geigy Ltd., Switzerland, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:244271-N)
00058606 Sachsse, K.; Suter, P.; Luetkemeier, H.; et al. (1979) CGA 64'250 Techn. Three
Months Toxicity Study on Rats: Project No. 790014. Final rept. (Unpublished
study received Jan 28, 1981 under 100-618; prepared by Ciba-Geigy Ltd.,
Switzerland, submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:244271-Q)
00058607 Sachsse, K.; Bathe, R.; Luetkemeier, H.; et al. (1979) CGA 64'250 3-Month
Toxicity Study on Dogs. Final rept. (Unpublished study received Jan 28, 1981
under 100-618; prepared by Ciba-Geigy Ltd., Switzerland, submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:244271-R)
00074506 Muecke, W. (1979) Characterization of Urinary and Faecal Metabolites of Rats
after Oral Application of CGA 64 250: Project Report 35/79. (Unpublished study
received Jun 8, 1981 under 100-EX-69; prepared by Ciba-Geigy Ltd.,
Switzerland, submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:070164-L)
00074507 Mucke, W. (1981) The Major Metabolic Pathways of CGA 64 250 in the Rat:
Project Report 9/81. (Unpublished study received Jun 8, 1981 under 100-EX-69;
prepared by Ciba-Geigy Ltd., Switzerland, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:070164-M)
00116591 Larson, E.; Matthews, R; Naismith, R; et al. (1982) 21 Day Dermal Toxicity
Study in Rabbits: (CGA-64250 Technical): PH 430-CG-001- 82. Rev.
(Unpublished study received Oct 4, 1982 under 100- 641; prepared by Pharmakon
Research International, Inc., submitted by Ciba-Geigy Corp., Greensboro, NC;
CDL:248442-E)
00129570 Hunter, B.; Scholey, D.; Haywood, R; et al. (1982) CGA 64 250: Long-term
Feeding Study in Mice: CBG/196/81827. Final rept. (Unpublished study received
Jul 21, 1983 under 100-641; prepared by Huntingdon Research Centre, Eng.,
submitted by Ciba-Geigy Corp., Greensboro, NC; CDL:250784-A; 250785;
250786)
00129918 Hunter, B.; Slater, N; Heywood, R; et al. (1982) CGA 64 250: Potential
Tumorigenic and Toxic Effects in Prolonged Dietary Administration to Rats:
CBG 193/8284 (Test No. 789023). Final rept. (Unpublished study received Jul 21,
1983 under 100-641; prepared by Huntingdon Research Centre, Eng., submitted
by Ciba- Geigy Corp., Greensboro, NC; CDL:250787-A; 250788; 250789;
250790)
00133343 Ami, P. (1982) Saccharomyces cerevisiae D7/Mammalian-microsome
Mutagenicity Test in vitro with CGA 64 250 (Test for Mutagenic Properties in
Yeast Cells): Experiment No. 811558. (Unpublished study received Dec 12, 1983
under 100-617; prepared by Ciba- Geigy Ltd., Switz., submitted by Ciba-Geigy
Corp., Greensboro, NC; CDL:072206-C)
00133347 Puri, E. (1982) Autoradiographic DNA Repair Test on Human Fibro- blasts: CGA
119
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00133348
00133349
00151514
00151515
00164795
40425001
40425004
41326701
41594801
42050501
42050502
64 250 (in vitro Test for DNA-damaging Properties): Experiment No. 811655.
(Unpublished study received Dec 12, 1983 under 100-617; prepared by Ciba-
Geigy Ltd., Switz., submitted by Ciba-Geigy Corp., Greensboro, NC;
CDL:072206-G)
Puri, E. (1982) Autoradiographic DNA Repair Test on Rat Hepatocytes: CGA 64
250 (in vitro Test for DNA-damaging Properties): Experiment No. 811514.
(Unpublished study received Dec 12, 1983 under 100-617; prepared by Ciba-
Geigy Ltd., Switz., submitted by Ciba-Geigy Corp., Greensboro, NC;
CDL:072206-H)
Strasser, F. (1982) BALB/3T3 Cell Transformation Assay: CGA 64 250 (in vitro
Test for Transformation-inducing Properties in Mammalian Fibroblasts):
Experiment No. 790806. (Unpublished study received Dec 12, 1983 under 100-
617; prepared by Ciba-Geigy Ltd., Switz., submitted by Ciba-Geigy Corp.,
Greensboro, NC; CDL 072206-J)
Borders, C.; Salamon, C. (1985) Two-Generation Reproduction Study in Albino
Rats with CGA-64250 Technical: Toxigenics Study 450- 1202. Unpublished
study prepared by Toxigenics, Inc. 1886 p.
Johnson, W.; Thompson, S. (1985) One-year Subchronic Oral Toxicity Study in
Beagle Dogs with CGA-64250 Technical: (Final Report): FDRL Study No. 7737.
Unpublished study prepared by Food and Drug Research Laboratories, Inc. 570 p.
Bissig, R. (1986) The Metabolism of [U-Carbon 14]-phenyl-CGA 64 250 in Mice
after Pretreatment with Unlabelled CGA 64 250: Project Report 6/86.
Unpublished study prepared by Ciba-Geigy Limited. 52 p.
Giknis, M. (1987) CGA-Technical: Teratology (Segment II) Study in Rats:
Laboratory Project ID 86004. Unpublished study performed by Ciba-Geigy
Corporation. 425 p.
Raab, D.; Youreneff, M.; Giknis, M.; et al. (1987) Propiconazole: A Teratology
Study in New Zealand Rabbits: Final Report Amendment No. 1: Laboratory
Project ID 86043. Unpublished study prepared by Ciba-Geigy Corporation. 125 p.
Cresswell, D. (1989) (U-carbon-14)-Phenyl CGA 64250: Absorption,
Distribution, Metabolism and Excretion in the Rat: Lab Project Number: 380/105.
Unpublished study prepared by Hazleton UK. 520 p.
Hartmann, H. (1988) CGA-64250 Technical: Acute Aerosol Inhalation Toxicity
Study in Rats: Lab Project Number: 871471. Unpublished study prepared by
Ciba-Geigy Ltd. 22 p.
Potrepka, R; Turnier, J. (1991) Subchronic Dietary Toxicity Study with CGA-
64250 in Mice: Lab Project Number: F-00098. Unpublished study prepared by
Ciba-Geigy Corp. 302 p.
Potrepka, R; Turnier, J. (1991) 13-Week Dietary Toxicity Study with CGA-
64250 in Male Mice: Lab Project Number: F-00107. Unpublished study prepared
120
-------
by Ciba-Geigy Corp. 226 p.
42403901
42415701
44381401
45215801
46604601
Mucke, W. (1983) The Metabolism of CGA-64250 in the Rat: Lab Project
Number: 24/83. Unpublished study prepared by Ciba-Geigy Ltd. 148 p.
Murphy, T. (1986) Dermal Absorption of ?carbon 14|-Propiconazole: Addendum
to ABR-86053: Lab Project Number: ABR-86064. Unpublished study prepared
by Ciba-Geigy Corp. 85 p.
Gerspach, R. (1997) CGA-64250 Technical: 18-Month Oncogenicity Study in
Mice: Lab Project Number: 943126. Unpublished study prepared by Novartis
Crop Protection Ag. 453 p.
Hardisty, J. (1997) 13-Week Dietary Toxicity Study with CGA-64250 in Male
Mice: Final Report: (Supplement for MRID No.42050502): Lab Project Number:
140-081: F-00107: 799-97. Unpublished study prepared by Experimental
Pathology Laboratories, Inc. 51 p.
Milburn, G. (2005) CGA 64250: Acute Neurotoxicity Study in Rats: Final Report.
Project Number: AR7501. Unpublished study prepared by Central Toxicology
Lab. (Syngenta). 648 p.
Environmental Fate
00067901
00067911
00129912
00129914
00133375
Burkhard, N. (1980) Rate of Hydrolysis of CGA-64250 under Laboratory
Conditions: Project Report 07/80. (Unpublished study received Jan 28, 1981
under 100-618; prepared by Ciba-Geigy, Ltd., Switzerland, submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:244269-C)
Miller, G.C. (1980) Photochemistry of CGA-64250. (Unpublished study received
Jan 28, 1981 under 100-618; prepared by Univ. of Nevada, Div. of
Biochemistry/Entomology, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:244269-M)
Keller, A. (1980) Degradation of CGA 64 250 (TILT) in Soil under Aerobic,
Aerobic/Anaerobic and Sterile/Aerobic Conditions. Project Report 22/80.
(Unpublished study received Jul 21, 1983 under 100-641; prepared by Ciba-
Geigy, Ltd., Switzerland, submitted by Ciba-Geigy Corp., Greensboro, NC;
CDL:250783-D)
Keller, A. (1982) Degradation of Carbon 14-dioxolane- and Carbon 14- phenyl-
ring Labeled CGA 64 250 (TILT) in Aerobic Soil: Project Report 08/82.
(Unpublished study received Jul 21, 1983 under 100-641; prepared by Ciba-
Geigy, Ltd., Switz., submitted by Ciba-Geigy Corp., Greensboro, NC;
CDL:250783-F)
Keller, A. (1982) Degradation of CGA 64250 (Tilt) in Aerobic Soil: Isolation and
Identification of the Major, Polar Soil Metabolite: Project Report 45/82.
(Unpublished study received Dec 12, 1983 under 100-617; prepared by Ciba-
Geigy Ltd., Switzerland, submitted by Ciba-Geigy Corp., Greensboro, NC;
121
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CDL:072211-H)
00133409
00155642
00159691
41727001
41811901
41811902
42347901
42415702
44701801
45528702
45528703
93194052
Rhoads, W.; Bruns, R.; Miller, B.; et al. (1982) Isolation and Identification of
Photolysis Products of CGA-64250: Project No. 1127. (Unpublished study
received Dec 12, 1983 under 100- 617; prepared by Rhoads Scientific Co.,
submitted by Ciba-Geigy Corp., Greensboro, NC; CDL:072220-C)
Ciba-Geigy Corp. (1985) [Field Dissipation Trials on Propiconazole],
Unpublished compilation. 1170 p.
Honeycutt, R. (1985) Field Dissipation Studies on CGA-64250 (Tilt): Report No.
EIR-85028: Field Test No. 5-FR-4-84. Unpublished study prepared by Ciba-
Geigy Corp. 446 p.
Saxena, A. (1988) The Adsorption and Desorption of Carbon 14 labeled
Propiconazole on Representative Agricultural Soils: Lab Project Number: HLA
6117-140. Unpublished study prepared by Hazleton Laboratories America, Inc.
73 p.
Das, Y. (1990) Photodegradation of Phenyl(U)-Carbonl4 Propiconazole in
Aqueous Solution Buffered at Ph 7 Under Artificial Sun- light: Lab Project
Number: 90070: 85-90. Unpublished study prepared by Innovative Scientific
Services, Inc. (ISSI). 86 p.
Spare, W. (1991) Soil Photolysis of Carbon 14-Propiconazole: Lab Project
Number: 12194: 113-90. Unpublished study prepared by Agrisearch Incorporated.
85 p.
Das, Y. (1992) Metabolism of Phenyl(U)-carbon 14 Propiconazole Under
Aerobic Aquatic Soil Conditions: Lab Project Number: 90071: 86-90.
Unpublished study prepared by Innovative Scientific Services, Inc. 122 p.
Das, Y. (1992) Metabolism of Phenyl (U)-carbon 14| Propiconazole Under
Anaerobic Aquatic Soil Conditions: Lab Project Number: 90072: 87-90.
Unpublished study prepared by Innovative Scientific Services, Inc. 164 p.
Atkins, R. (1998) Aged Leaching of (carbon-14)Propiconazole in Four Soil
Types: Lab Project Number: 1093: 212-97: 2027. Unpublished study prepared by
PTRL East, Inc. 504 p.
Manuli, P.; Kludas, R. (2001) Terrestrial Field Dissipation of Propiconazole
(Banner MAXX) Applied to Turf Bare Ground in California: Final Report
Addendum: Lab Project Number: GR97-283: 296-97. Unpublished study
prepared by Grayson Research, LLC. 107 p.
Manuli, P.; Jacobson, B. (1999) Terrestrial Field Dissipation of Tilt on Bare Soil
in California: Final Report: Lab Project Number: 242-28: 115-97. Unpublished
study prepared by Waterborne Environmental, Inc. 299 p.
Hochman, J. (1990) Ciba-Geigy Corp. Phase 3 Summary ofMRID 00067901.
Propiconazole - Hydrolysis Study: Project 07/80. Prepared by CIBA-GEIGY
122
-------
Limited, lip.
Occupational/Residential Exposure
00133390 Honeycutt, R. (1983) CGA-64250 (Tilt): Worker Exposure in Rice: Re- port No.
EIR-83011. (Unpublished study received Dec 12, 1983 under 100-617; submitted
by Ciba-Geigy Corp., Greensboro, NC; CDL:07222-C)
42564003 Avakian, M. (1991) Propiconazole-Dislodgeable Residue on Corn-North
Carolina: Final Study Report: Lab Project Number: S59MZ01. Unpublished study
prepared by Environmental Technologies Institute, Inc. and EN-CAS Labs. 250 p.
44959701 Rosenheck, L. (1999) Dissipation of Dislodgeable Foliar Residues of Two
Formulations of Propiconazole (Orbit and Orbit 45W) Applied to Peaches: Final
Report: Lab Project Number: 260-98: 44580: AG-561. Unpublished study
prepared by ABC Labs., Inc. 239 p. {OPPTS 875.2100}
44959702 Rosenheck, L. (1999) Dissipation of Dislodgeable Foliar Residues of
Propiconazole (Banner MAXX) Applied to Commercial Ornamentals: Final
Report: Lab Project Number: 1134-99. Unpublished study prepared by Novartis
Crop Protection, Inc. 51 p. {OPPTS 875.2100}
45288601 Rosenheck, L.; Meyer, L. (2000) Determination of Transferable Turf Residue on
Turf treated with Banner MAXX (Propiconazole): Final Report: Lab Project
Number: 990046: 179-99. Unpublished study prepared by Central California
Research Laboratories, Inc. 225 p. {OPPTS 875.2100}
45469501 Klonne, D.; Fuller, R.; Howell, C. (2000) Determination of Dermal and Inhalation
Exposure to Reentry Workers during Pruning in Nursery Stock: Lab Project
Number: ARF043: 45949: HL 10258. Unpublished study prepared by ABC
Laboratories, Inc. 391 p. {OPPTS 875}
45469502 Klonne, D.; Fuller, R.; Howell, C. (2000) Determination of Dermal and Inhalation
Exposure to Reentry Workers during Harvesting in Nursery Stock: Lab Project
Number: 45950: ARF044. Unpublished study prepared by ABC Laboratories,
Inc. 307 p. {OPPTS 875}
45524304 Bestari, K.; Macey, K.; Solomon, K. et al. (1999) Measurement and Assessment
of Dermal and Inhalation Exposures to Didecyldimethylammonium Chloride
(DDAC) Used in the Protection of Cut Lumber (Phaselll). Unpublished study
prepared by University of Guelph. 309 p.
46513901 Klonne, D.; Belcher, T. (2005) Determination of Dermal and Inhalation Exposure
to Reentry Workers During Harvesting in Greenhouse Grown Cut Flowers.
Project Number: ARF055, ARTF/ARF055. Unpublished study prepared by
Access Research and Consulting, Inc. and Central California Research
Laboratories. 538 p.
ORTF OMA002 ORETF Handler Exposure Monitoring studies for Lawn Care Operators: LCO
123
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low-pressure, high-volume turfgun with Dacthal
ORTF OMA004 ORETF Handler Exposure Monitoring studies for Lawn Care Operators:
Residential handler, hose-end sprayer
Residue Chemistry Bibliography
00067905 Fischer, W.C.; Cassidy, J.E. (1980) Balance and Metabolism of Triazole-14IC-
CGA-64250 in a Lactating Goat: Report No. ABR-80036. (Unpublished study
received Jan 28, 1981 under 100-618; submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:244269-G)
00074495 Marco, G.J.; Kahrs, RA. (1981) CGA-64250—Rice and Pecans: Residues
Observed and Metabolism Data Including the Analytical Methods Used: Report
No. ABR-81020. (Unpublished study received Jun 8, 1981 under 100-EX-69;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:070163-A)
00074496 Madrid, S.; Cassidy, J.E. (1980) The Uptake, Distribution and Characterization of
Triazole- and Phenyl-14IC-CGA-64250 and Their Metabolites in Greenhouse-
grown Peanuts: Report No. ABR- 80006. (Unpublished study received Jun 8,
1981 under 100-EX-69; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:070164-A)
00074498 Madrid, S.O.; Cassidy, J.E. (1981) The Uptake, Distribution and Characterization
of Triazole-A14IC-CGA-64250 and Their Metabolites in Field-grown Peanuts:
Report No. ABR-81013. (Unpublished study received Jun 8, 1981 under 100-EX-
69; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:070164-C)
00074499 Seim, V.; Brown, G. (1979) Biological Report for the Metabolism of Triazole-
A14IC-CGA-64250 and Phenyl-14IC-CGA-64250 When Applied as a Foliar
Spray to Greenhouse Grown Peanuts: Report No. BIOL-79007. (Unpublished
study received Jun 8, 1981 under 100-EX-69; submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:070164-D)
00074500 Blattmann, P. (1979) Metabolism of CGA 64 250 in Field Grown Wheat: Project
Report 36/79. (Unpublished study received Jun 8, 1981 under 100-EX-69;
prepared by Ciba-Geigy, Ltd., Switzerland, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:070164-E)
00074501 Blattmann, P. (1980) Proposed Pathways for the Degradation of CGA 64 250 in
Field Grown Wheat: Project Report 17/80. (Unpublished study received Jun 8,
1981 under 100-EX-69; prepared by Ciba-Geigy Ltd., Switzerland, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:070164-F)
00074502 Blattmann, P. (1980) Metabolism of CGA 64 250 in Grapevine: Project Report
42/80. (Unpublished study received Jun 8, 1981 under 100-EX-69; prepared by
Ciba-Geigy Ltd., Switzerland, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:070164-G)
00074503 Madrid, V.; Cassidy, J.E. (1981) Characterization of Metabolites in Urine, Milk
124
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00074504
00074508
00074509
00074510
00074511
00129915
00133385
00137150
00137861
00138266
00153327
00155644
and Liver of a Goat Treated with Triazole-A14IC- CGA-64250: Report No. ABR-
81007. (Unpublished study received Jun 8, 1981 under 100-EX-69; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:070164-I)
Seim, V.W.; Thomas, W.A. (1980) Biological Report for the Metabolism of
Triazole-14IC-CGA-64250 in aLactating Goat: Report No. BIOL-80004.
(Unpublished study received Jun 8, 1981 under 100-EX-69; submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:070164-J)
Ciba-Geigy Corporation (1981) Residues of CGA-64250 in Rice Field Studies):
AG-A 6144. (Compilation; unpublished study, including AG-A 6195, AG-A
6196, AG-A 6212, received Jun 8, 1981 under 100-EX-69; CDL:070165-A)
Ciba-Geigy Corporation (1981) ?Residues of CGA-64250 in Pecans in Field
Studies): AG-A 6203. (Compilation; unpublished study, including AG-A 6291,
received Jun 8, 1981 under 100-EX-69; CDL:070165-B)
Ciba-Geigy Corporation (1981) Residues of CGA-64250 in Soybeans in Field
Studies): AG-A 6101. (Unpublished study received Jun 8, 1981 under 100-EX-69;
CDL:070165-C)
Ross, J. A. (1981) Stability of Residues of CGA-64250 under Freezer Storage
Conditions: Report No. ABR-81018. (Unpublished study received Jun 8, 1981
under 100-EX-69; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:070165-D)
Staley, J.; Madrid, S.; Cassidy, J. (1982) The Uptake of Triazole - Carbon 14-
CGA-64250 and Its Soil Degradation Products in Field Rotational Winter Wheat,
Lettuce, Corn and Carrots: Report No.: ABR-82007. (Unpublished study received
Jul 21, 1983 under 100-641; submitted by Ciba-Geigy Corp., Greensboro, NC;
CDL: 250783-G)
Ciba-Geigy Corp. (1983) CGA-64250: Pecans. (Compilation; unpublished study
received Dec 12, 1983 under 100-617; CDL:072212-A; 072213; 072214; 072215;
072216; 072217)
Ciba-Geigy Corp. (1984) CGA-64250—Bananas. (Compilation; unpublished
study received Jan 17, 1984 under 4E3026; CDL:072285-A)
Ciba-Geigy Corp. (1984) ?Residue: CGA-64250—Rice|. (Compilation;
unpublished study received Apr 6, 1984 under 4F3074; CDL: 072556-A; 072557)
Honeycutt, R. (1983) Rotational Crop Studies with CGA-64250: Report No. EIR-
83014. (Unpublished study received Apr 4, 1984 under 100-617; submitted by
Ciba-Geigy Corp., Greensboro, NC; CDL: 253013-A)
Cheung, M. (1985) CGA-64250-Pecans: Response to EPA's Questions Regarding
Section D: [Residue Chemistry]: Report No. ABR-85050. Unpublished study
prepared by Ciba-Geigy Corp. 9 p.
Szolics, I.; Simoneaux, B. (1985) Metabolism Data and Correlation of
125
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00155645
00164802
40150701
40154501
40180701
40180702
40692201
40692203
40692204
40692206
40783303
Metabolites in Target and Rotation Crops of Propiconazole: Report No. ABR-
85056. Unpublished study prepared by Ciba-Geigy. 45 p.
Madrid, S.; Cassidy, J. (1983) Soil Uptake of Phenyl [Carbon-14] vs. Triazole
[Carbon-14]-CGA-64250 in Target Peanuts Followed by Rotational Winter
Wheat and Corn — A Side by Side Comparison Study in the Greenhouse:Report
No. 83030. Unpublished study prepared by Ciba-Geigy. 38 p.
Honeycutt, R. (1986) Additional Residue Information on Terrestrial Rotation
Crops Grown after Use of Propiconazole on Wheat, Barley or Rye: Report No.
EIR-86016. Unpublished compilation prepared by Ciba-Geigy Corporation. 378
P-
Cheung, M. (1987) Response to EPA's Concern Regarding the Validity of
Analytical Method AG-359 to Determine Propiconazole Residues in Animal
Commodities: (Magnitude of Residues): Lab Study No.: ABR-87039.
Unpublished study prepared by Ciba-Geigy Corp. 624 p.
Cheung, M. (1987) Response to EPA's Request for Additional Recovery
Information on Analytical Methods AG-454A and AG-517: Lab Study No.:
ABR-87040. Unpublished study prepared by Ciba-Geigy Corp. 68 p.
Toth, J.; Manuli, P. (1986) Determination of Total Residues of Pro- piconazole in
Crops as 2,4-Dichlorobenzoic Acid by Capillary Gas Chromatography: Method
No. AG-454A. Unpublished study prepared by Ciba-Geigy Corp. 5 p.
Manuli, P. (1987) Determination of Total Residues of Propiconazole in Meat,
Milk and Eggs as 2,4-Dichlorobenzoic Acid by Capillary Gas Chromatography:
Laboratory/Study No. AG-517. Unpublished study prepared by Ciba-Geigy Corp.
4 p.
Cheung, M. (1988) Propiconazole—Peanuts: Magnitude of Residue: Laboratory
Project ID: ABR-88068. Unpublished study prepared by Ciba-Geigy Corp. 128 p.
Perez, R; Toth, J. (1985) Determination of Total Residues of Propiconazole in
Crops as 2,4-dichlorobenzoic acid by Capillary Gas Chromatography: Laboratory
Project ID: AG-454. Unpublished study prepared by Ciba-Geigy Corp. 31 p.
Perez, R. (1985) Validation of Analytical Methods AG-448 and AG-454 for the
Determination of Residues of Propiconazole in Crops by Conversion to 2,4-
dichlorobenzoic acid: Laboratory Project ID: ABR-85055. Unpublished study
prepared by Ciba-Geigy Corp. lip.
Nixon, W.; Rhoads, W. (1983) Validation of Analytical Methods AG- 448 and
AG-454 for the Determination of Residues of CGA-64250 in Crops by
Conversion to 2,4-dichlorobenzoic acid: Laboratory Pro- ject ID: ABR-83078.
Unpublished study prepared by Ciba-Geigy Corp. 14 p.
Cheung, M. (1988) Propiconazole-Corn: Magnitude of Residues: Project ID:
ABR-88054. Unpublished study prepared by Ciba-Geigy Corp. 208 p.
126
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40783306
40890701
41063801
41063802
41102001
41486801
41486802
41823301
41823302
41823304
41823305
42061301
42182901
Cheung, M. (1988) Propiconazole-Pineapple: Magnitude of Residue: Project ID:
ABR-88014. Unpublished study prepared by Ciba-Geigy Corp. 70 p.
Perez, R.; Toth, J. (1985) Determination of Total Residues of CGA- 64250 in
Pineapples as 2,4-Dichlorobenzoic Acid by Capillary Gas Chromatography:
Project ID: AG-448. Unpublished study prepared by Ciba-Geigy Corp. 30 p.
Cheung, M. (1988) Propiconazole—Grasses Grown for Seed Magnitude of
Residue: Laboratory Project ID ABR-88134. Unpublished study prepared by
Ciba-Geigy Corp. 83 p.
Cheung, M. (1989) Propiconazole—Wild Rice Residue Summary: Project ID:
ABR-89004. Unpublished study prepared by Ciba-Geigy Corp. 99 p.
Cheung, M. (1989) Propiconazole-Stoned Fruit Residue Summary: Project ID:
ABR-89007. Unpublished study prepared by Ciba-Geigy Corp. 152 p.
Cheung, M. (1989) Propiconazole in Soybean Beans, Forage, Hay, and Fodder
Double-Cropped behind Winter Wheat: Project No. ABR- 89030. Unpublished
study prepared by Ciba-Geigy Corp. 127 p.
Cheung, M. (1990) Propiconazole: Response to EPA Conclusions: Pro-
piconazole-celery Magnitude of Residue (Addendum to ABR-88057, MRID No.
40783301): Lab Project I.D.: ABR-90026. Unpublished study prepared by Ciba-
Geigy Corp., Agricultural Div. 49 p.
Darnow, J. (1990) Propiconazole: Determination of Extract Storage Stability for
Total Propiconazole Residues in Weathered Crops: Lab Project I.D.: ABR-90017.
Unpublished study prepared by Ciba-Geigy Corp., Agricultural Div. 56 p.
Doweyko, A. (1990) Metabolism of Phenyl carbon 14 Propiconazole in Goats:
Lab Project Number: F-00052. Unpublished study pre- pared by Ciba-Geigy
Corp. 66 p.
Doweyko, A. (1990) Metabolism of Phenyl carbon 14|Propiconazole in Chickens:
Lab Project Number: F-00051. Unpublished study pre- pared by Ciba-Geigy
Corp. 71 p.
Yokley, R. (1990) Validation of Analytical Method AG-517 for the
Determination of Total Residues of Propiconazole in Goat Tissues, Milk, and
Blood and Poultry Tissues: Lab Project Number: abr-90067. Unpublished study
prepared by Ciba-Geigy Corp. 54 p.
Beidler, W. (1991) Propiconazole: Magnitude of Residues of Propiconazole in
Grasses Grown for Seed Following Application of Tilt 3.6E: Lab Project Number:
ANR-90101. Unpublished study prepared by Ciba-Geigy Corp. 155 p.
Biehn, W. (1991) Propiconazole—Magnitude of Residue on Mint: Lab Project
Number: IR-4 PR 4127. Unpublished study prepared by Ciba-Geigy Corp. 101 p.
Cheung, M. (1991) Propiconazole Residues in Oat Forage, Straw, Grain and Oat
Grain Processed Fractions Resulting from Application of Tilt: Residue Summary
127
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42564004
42564005
42564006
42605801
42634101
42634102
42915601
42983001
43314201
43314202
with Amendment 1: Lab Project Number: ABR-89102. Unpublished study
prepared by Ciba-Geigy Corp. 214 p.
Smith, J. (1991) Propiconazole: Response to EPA Review ofPropiconazole
(TILT 3.6E) on Wild Rice Including Results of Additional Field Trials: Lab
Project Number: ABR-90091. Unpublished study prepared by Ciba-Geigy Corp.
74 p.
Cheung, M. (1992) Responses to EPA Review of Residue Data for Propiconazole
on Corn: Lab Project Number: ABR-92064. Unpublished study prepared by Ciba-
Geigy Corp. 91 p.
Manuli, P. (1992) Magnitude of Residues ofPropiconazole in Field Corn Forage
and Grain and Processed Fractions following Application of Tilt 3.6E
Formulation to Field Corn: Lab Project Number: ABR-92047. Unpublished study
prepared by Ciba-Geigy Corp. 161 p.
Doweyko, A. (1992) F-00052: Metabolism of Phenyl-carbon 14 Propiconazole in
Goats: Addendum 1 to Final Report. Unpublished study prepared by Ciba-Geigy
Corp. 9 p.
Cheung, M. (1992) Propiconazole: Responses to EPA Review of Residue Data
for Propiconazole on Peanuts Reported in ABR-88068 MRID Number 40692201:
Lab Project Number: ABR-92066. Unpublished study prepared by Ciba-Geigy
Corp. 26 p.
Smith, J. (1992) Magnitude of Residues ofPropiconazole in or on Grasses Grown
for Seed following Application of Tilt 3.6E: Lab Project Number: ABR-92070.
Unpublished study prepared by Ciba-Geigy Corp. 165 p.
Wurz, R. (1993) Propiconazole: Magnitude of the Residue in or on Grass Seed
Screening Pellets Obtained from Market Basket Samplings: Lab Project Number:
ABR-92071. Unpublished study prepared by Ciba-Geigy Corp. 83 p.
Watson, G. (1993) Letter sent to C. Lewis dated September 3, 1993 concerning a
report ofPropiconazole residues above current tolerance in rice commodities.
Prepared by Ciba-Geigy Corp. 10 p.
Doweyko, A. (1990) Metabolism of (Phenyl-(carbon 14)) -Propiconazole in
Chickens: Addendum I: Lab Project Number: F-00051. Unpublished study
prepared by Ciba-Geigy Corp. lip.
Wurz, R. (1994) Stability of Total Residues ofPropiconazole in Weathered Grass
Straw, Forage and Seed Samples under Freezer Storage Conditions: Lab Project
Number: ABR/94008. Unpublished study prepared by Ciba-Geigy Corp.,
Biochemistry Dept. 62 p.
Beidler, W. (1994) Response to EPA Review of Petition for Tolerances of
Propiconazole in Oat Grain and Straw: Lab Project Number: ABR/93068.
Unpublished study prepared by Ciba-Geigy Corp. Biochemistry Dept. lip.
128
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43434201
43655609
43825401
43825402
44049601
44142401
44381402
44411201
44411204
44411205
Thompson, D. (1994) Propiconazole: Magnitude of Residue on Mint-
Amendment: Lab Project Numbers: A4127: 4127: A4127.93-CIR01.
Unpublished study prepared by EPL Bioanalytical Services, Inc.; and Ciba Plant
Protection. 402 p.
Biehn, W. (1994) Propiconazole: Magnitude of Residue on Mushroom: Lab
Project Number: 5056: 207S01: 5056.92-PA05. Unpublished study prepared by
EPL Bio-Analytical Services, Inc.; and Lehigh Agricultural & Biological
Services, Inc. 291 p.
Selman, F. (1995) Propiconazole—Magnitude of the Residues in or on Cherries
Following Post Foliar Applications of Orbit: Lab Project Number: ABR/95004.
Unpublished study prepared by Ciba Plant Protection. 225 p.
Lin, K. (1995) Propiconazole: Investigations into the Methylation of 2,4-
Dichlorobenzoic Acid as a Part of Analytical Methods AG-517 and AG-454B:
Lab Project Number: ABR-94065: 411925: 280-94. Unpublished study prepared
by Ciba-Geigy Corp. 141 p.
Eudy, L. (1995) Propiconazole: Stability of Propiconazole Fortified into Crops
and Processed Fractions Under Freezer Storage Conditions: Interim Report: Lab
Project Number: ABR-95092: 411925: 207-94. Unpublished study prepared by
Ciba-Geigy Corp. 113 p.
Simoneaux, B. (1996) Uptake and Metabolism of CGA-64250 in Greenhouse
Grown Celery after Spray Treatment with Phenyl-(carbon 14)-CGA-64250: Lab
Project Number: ABR-95100: 271-94: BIOL-94015. Unpublished study prepared
by Ciba Crop Protection. 144 p.
Close, C. (1996) (Carbon 14)-Propiconazole: Uptake and Metabolism in Seed
Piece Dipped Sugarcane: (Final Report): Lab Project Number: ABR-96097: 73-
95: ANPHI-96005. Unpublished study prepared by Ciba-Geigy Corp. 56 p.
Swain, W. (1997) Uptake and Metabolism of CGA-64250 in Greenhouse Grown
Spring Wheat after Spray Treatment with Phenyl—(carbon 14)-CGA—64250: Lab
Project Number: ABR-97039: 502-95: BIOL-95018. Unpublished study prepared
by Novartis Crop Protection, Inc. 170 p.
Lin, K. (1997) Determination of Total Residues of Propiconazole in Crops as 2,4-
Dichlorobenzoic Acid Methyl Ester by Capillary Gas Chromatography: Lab
Project Number: AG-626: 571-97: 411925. Unpublished study prepared by
Novartis Crop Protection, Inc. 45 p. {OPPTS 860.1340}
Lin, K. (1997) Determination of Total Residues of Propiconazole in Meat, Milk
and Eggs as 2,4-Dichlorobenzoic Acid Methyl Ester by Capillary Gas
Chromatography: Lab Project Number: AG-629: 572-97: 411925. Unpublished
study prepared by Novartis Crop Protection, Inc. 44 p. {OPPTS 860.1340}
Eudy, L. (1997) Stability of Propiconazole Fortified into Crops and processed
Fractions Under Freezer Storage Conditions: Lab Project Number: ABR-97085:
129
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207-94: 477925. Unpublished study prepared by Novartis Crop Protection, Inc. 84
p. {OPPTS 860.1380}
44411206 Vincent, T. (1997) Propiconazole—Magnitude of the Residues in or on Wheat,
Including Processed Fractions and Rotational Lentils and Peas, Following Post
Foliar Applications of Tilt: Lab Project Number: ABR-95062: 29-92: 411124.
Unpublished study prepared by Novartis Crop Protection, Inc. 506 p.
44411207 Vincent, T. (1997) Propiconazole—Magnitude of the Residues in or on Wheat,
Including Processed Fractions, Following an Application of Tilt: Lab Project
Number: ABR-97101: 94-95: 411926. Unpublished study prepared by Novartis
Crop Protection, Inc. 314 p. Relates to L0000296.
44411208 Vincent, T. (1997) Propiconazole—Magnitude of the Residues in or on Rice
Following Application of Tilt: Lab Project Number: ABR-97110: 49-96: 411927.
Unpublished study prepared by Novartis Crop Protection, Inc. 120 p.
44757208 Vincent, T.; Ediger, K. (1999) Propiconazole and CGA-279202—Magnitude of
the Residues in or on Wheat: Final Report: Lab Project Number: 43-97: 0S-FR-
103-97: 02-FR-002-97. Unpublished study prepared by Novartis Crop Protection,
Inc. 1304 p. {OPPTS 860.1000, 860.1500, 860.1520}
93194062 Swidersky, P. (1990) Ciba-Geigy Corp. Phase 3 Summary ofMRID 00155644
and Related MRIDs 00074496, 00074499, 00074497, 00155646. Metabolism
Data and Correlation of Metabolites in Target and Rotation Crop of
Propiconazole: Report No. ABR-85056. Prepared by CIBA-GEIGY CORP. 17 p.
93194064 Wurz, R. (1990) Ciba-Geigy Corp. Phase 3 Summary ofMRID 40180701 and
Related MRIDs 40022401, 40154501, 40692204. Analytical Method for the
Determination of Total Residues of Propiconazole in Crops as 2,4-
Dichlorobenzoic Acid: AG-454A. Prepared by CIBA-GEIGY CORP. 14 p.
93194067 Wurz, R. (1990) Ciba-Geigy Corp. Phase 3 Summary ofMRID 40180702 and
Related MRIDs 40145401. Analytical Method for the Determination of Total
Residues of Propiconazole in Meat, Milk, and Eggs as 2,4-Dichlorobenzoic Acid:
AG-517. Prepared by CIBA-GEIGY CORP. 13 p.
93194068 Beidler, W.; Senzel, A. (1990) Ciba-Geigy Corp. Phase 3 Summary ofMRID
00133385 and Related MRIDs 00074510, 00074511. Stability of Propiconazole
Residues in Crops Under Freezer Storage Conditions: Projects ABR-83086 and
ABR-81018. Prepared by CIBA-GEIGY CORP. 11 p.
93194070 Senzel, A.; Ross, J.; Clear, C. (1990) Ciba-Geigy Corp. Phase 3 Summary of
MRID 00137861. Cow Meat and Milk—Feeding: Propiconazole Residues:
Projects ABR-84022 and 83091; and Poultry Meat and Eggs: Feeding:
Propiconazole Residues: Projects ABR-84022 and 83092. Prepared by Ciba-
Geigy Corporation. 36 p.
93194071 Senzel, A.; Ross, J.; Clear, C. (1990) Ciba-Geigy Corp. Phase 3 Summary of
MRID 00137150. Magnitude of the Residues of Propiconazole in Bananas: ABR-
130
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93194072
93194073
93194075
93194077
93194079
93194080
93194085
Other Studies
00067924
00132930
00151517
83100. Prepared by CffiA-GEIGY CORP. 19 p.
Senzel, A.; Ross, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID
00163643. Magnitude of the Residues of Propiconazole in Wheat, Barley, and
Rye: Project ABR-84018. Prepared by CffiA-GEIGY CORP. 16 p.
Senzel, A.; Ross, J.; Clear, C. (1990) Ciba-Geigy Corp. Phase 3 Summary of
MRID 40890701. Magnitude of the Residues of Propiconazole in Grasses for
Seed: Project ABR-83100. Prepared by CffiA-GEIGY CORP. 17 p.
Senzel, A.; Ross, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID
00163687 and Related MRIDs 00074508, 00074509, 00074495, 00137861,
00163643, 41063801. Magnitude of the Residues of Propiconazole in Rice:
Project ABR-84022. Prepared by CffiA-GEIGY CORP. 15 p.
Senzel, A.; Ross, J.; Clear, C. (1990) Ciba-Geigy Corp. Phase 3 Summary of
MRID 00131090. Magnitude of the Residues of Propiconazole in Sugarcane:
Project ABR-83065. Prepared by CffiA-GEIGY CORP. 28 p.
Senzel, A.; Ross, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID
00163687 and Related MRIDs 00074495, 00074508. Magnitude of the Residues
of Propiconazole in Processed Food/Feed from Rice: Project ABR-84022.
Prepared by CffiA-GEIGY CORP. 20 p.
Senzel, A.; Ross, J.; Clear, C. (1990) Ciba-Geigy Corp. Phase 3 Summary of
MRID 00163643. Magnitude of the Residues of Propiconazole in Processed
Food/Feed from Wheat: Project ABR-84018. Prepared by CffiA-GEIGY CORP.
18 p.
Madrid, V.; Cassidy, J. (1990) Ciba-Geigy Corp. Phase 3 Reformat of MRID
00074503 and Related MRIDs 00067905, 00074504. Characterization of
Metabolites in Urine, Milk and Liver of a Goat Treated with Triazole-(Carbon
14)-CGA-64250: Propiconazole. Prepared by CffiA-GEIGY CORP. 54 p.
Thompson, C.M.; Griffen, J.; Cranor, W. (1980) Acute Toxicity of CGA-64250 to
Channel Catfish (Ictaluruspunctatus): Static Acute Bioassay Report # 26039.
(Unpublished study received Jan 28, 1981 under 100-618; prepared by Analytical
Bio Chemistry Laboratories, Inc., submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:244273-D)
De Morsier, A.; Kurmann, F.; Mendezu, C.; et al. (1982). Report on the Test for
Acute Toxicity of CGA 64 250 to Cat Fish: Project No. 81 03 04. (Unpublished
study received Dec 12, 1983 under 100-617; prepared by Ciba-Geigy Ltd., Switz.,
submitted by Ciba-Geigy Corp., Greensboro, NC; CDL:072209-L)
Froehlich, E.; Bentley, P.; Staeubli, W.; et al. (1984) Promotion Study with CGA
64250: [Study on the Influence of CGA 64250 in the Formation of Focal
Proliferative Changes in the Rat Liver]: GU Exploratory Research Project No.
131
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834015. Unpublished study prepared by Ciba-Geigy Ltd. 553 p.
40425002
45215802
45215803
Mallows, S.; Levy, E.; Goknis, M.; et al. (1987) CGA-64250: A Modified
Teratology (Segment II) Study in Albino Rats ...: Laboratory Project ID 86189.
Unpublished study prepared by Ciba-Geigy Corporation. 408 p.
Weber, E. (1999) Assessment of Hepatic Cell Proliferation in Male Mice
(Propiconazole): Final Report: Lab Project Number: CB 97/23: 539-98.
Unpublished study prepared by Novartis Crop Protection AG. 59 p.
Beilstein, P. (1998) Effects on Biochemical Parameters in the Liver Following
Administration to Male Mice: Final Report (Propiconazole): Lab Project Number:
CB 97/22: 798-97. Unpublished study prepared by Novartis Crop Protection AG.
68 p.
132
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APPENDIX D: Technical Support Documents for Propiconazole
Additional documentation in support of this RED is maintained in EPA's Pesticide Docket under
docket number EPA-HQ-OPP-2005-0497. This docket may be viewed, in paper form, in the OPP
docket room located at Room S-4900, One Potomac Yard, 2777 South Crystal Drive, Arlington, VA.
The docket is open Monday through Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
All documents in this docket may also be viewed or downloaded via the Internet at
http://www.regulations.gov, under the docket number listed above.
The Preliminary Risk Assessments for Propiconazole, which were made publicly available on
February 15, 2006, and public comments on these risk assessments, are also available under docket
number EPA-HQ-OPP-2005-0497. Registrant requests to amend their propiconazole registrations to
delete certain uses, and the March 8, 2006 Federal Register Notice announcing receipt of this are also
available under this docket number.
Final revised risk assessment documents supporting the reregistration eligibility decision for
propiconazole are listed below. These documents may also be viewed in the Pesticide docket, or
viewed or downloaded from the Internet as described above.
Human Health Risk Assessment Documents
1. Propiconazole: Phase4, HED Chapter of the Reregistration Eligibility Decision Document
(RED). June 28, 2006.
2. Propiconazole: Phase IV, revised Occupational and Residential Exposure Assessment for the
Reregistration Eligibility Decision Document (RED). June 15, 2006.
3. Propiconazole: Amendment to the Propiconazole Reregistration Eligibility Decision (RED)
Document for Children's Postapplication Exposure Treated Structures. June 20, 2006.
4. Propiconazole Revised Acute and Chronic Dietary Exposure Assessments for Reregistration
Evaluation [sic] Decision (RED) - Phase 4. June 7, 2006.
5. Propiconazole (122101): Reregistration Eligibility Decision (RED) Document; Revised Residue
Chemistry Considerations. June 15, 2006.
Environmental Fate and Ecological Effects Documents
6. Environmental Fate and Effects Division Revised RED for the Reregistration of Propicnazole.
June 29, 2006.
7. Terrestrial Plant Runoff Risk Assessment for Propiconazole on Turf Using PRZM. July 14, 2006.
8. Revised Drinking Water Assessment of Propiconazole. June 7, 2006.
Risk Assessments and Related Documents for the Free Triazoles
9. Meeting Summary: EPA/FDA Joint Teleconference on July 11, 2006 to Discuss 1,2,4-Triazole
(Free TRiazole) as a Common Metabolite of Triazole Derivative Fungicides and Anastrozole, a
Drug. July 18, 2006.
10. EPA 1,2,4-Triazole Consult Response. Memo from John Lazor, Director, FDA Division of
Clinical Pharmacology 4, to Debra Edwards, Director, Special Review and Reregistration
Division. May 19, 2006.
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11. 1,2,4-Triazole, Triazole Alanine, Triazole Acetic Acid: Human Health Aggregate Risk Assessment
in Support ofReregistration and Registration Actions for Triazole-derivative Fungicide
Compounds. Michael Doherty et al. February 7, 2006.
12. Response to Triazole Task Force Comments on the FQPA Drinking Water Assessment for 1,2,4-
Triazole (!,2,4-T), Triazole alanine (TA), and Triazole Acetic Acid (TAA). June 15, 2006.
Documents on Propiconazole Use and Usage
13. Usage Report Package in Support of Reregistration for the Fungicide Propiconazole (122101).
April 26, 2006.
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APPENDIX E: Generic Data Call-in (DCI) for Propiconazole
This is a placeholder for the Generic DCIfor the pesticide active ingredient
propiconazole. The Generic DCI has not yet been issued and will be issued at a future
date. Generic data requirements for propiconazole are listed in the RED document.
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APPENDIX F: Product-specific Data Call-in (DCI) for Propiconazole
This is a placeholder for the Product DCIfor all pesticide products containing the
pesticide active ingredient propiconazole. The Product DCI has not yet been issued
and will be issued at a future date.
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APPENDIX G: Batching of Propiconazole Products
for Meeting Acute Toxicity Testing Data Requirements
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 PROPICONAZOLE 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.
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Seventy nine products were found which contain Propiconazole as the active ingredient.
These products have been placed in fourteen batches and a no batch group in accordance with the
active and inert ingredients and type of formulation.
Batching Instructions:
Batch 13: Studies should be conducted on EPA Reg. No. 60061-119
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
100-618
95.0
43813-13
95.0
62719-347
93.8
66222-59
93.0
74054-2
93.0
74054-3
93.0
Batch 2
EPA Reg. No.
Percent Active Ingredient
43813-21
50.0
43813-37
50.0
Batch 3
EPA Reg. No.
Percent Active Ingredient
100-780
45.0
100-781
45.0
100-1153
45.0
Batch 4
EPA Reg. No.
Percent Active Ingredient
100-736
41.8
100-737
41.8
Batch 5
EPA Reg. No.
Percent Active Ingredient
100-617
41.8
100-702
41.8
100-1233
41.8
62719-346
41.8
66222-42
41.8
66222-118
41.8
Batch 6
EPA Reg. No.
Percent Active Ingredient
43813-15
23.6
43813-16
23.6
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Batch 7
EPA Reg. No.
Percent Active Ingredient
43813-41
15.0
43813-42
15.0
Batch 7
EPA Reg. No.
Percent Active Ingredient
53883-174
14.3
66222-41
14.3
Batch 8
EPA Reg. No.
Percent Active Ingredient
100-741
14.3
100-772
14.3
228-396
14.3
34704-879
14.3
53883-129
14.3
60063-27
14.3
66330-325
14.3
69117-3
14.3
72112-3
14.3
79676-8
14.3
Batch 9
EPA Reg. No.
Percent Active Ingredient
43813-19
9.7
75506-3
9.7
Batch 10
EPA Reg. No.
Percent Active Ingredient
70227-6
4.5
71406-1
4.5
Batch 11
EPA Reg. No.
Percent Active Ingredient
100-773
1.55
100-952
1.55
53883-128
1.55
53883-184
1.55
Batch 12
EPA Reg. No.
Percent Active Ingredient
43813-43
Propiconazole: 34.0
IPBC: 16.0
43813-44
Propiconazole: 34.0
IPBC: 16.0
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Batch 13
EPA Reg. No.
Percent Active Ingredient
60061-103
Propiconazole: 0.21
IPBC: 0.21
Tebuconazole: 0.21
60061-109
Propiconazole: 0.10
IPBC: 0.10
Tebuconazole: 0.10
60061-119
Propiconazole: 0.98
IPBC: 0.98;Tebuconazole: 0.98
Batch 14
EPA Reg. No.
Percent Active Ingredient
74405-1
Propiconazole: 0.70
Permethrin: 0.35
Tebuconazole: 0.70
75101-1
Propiconazole: 0.50
Permethrin: 0.43
Tebuconazole: 0.51
No Batch
EPA Reg. No.
Percent Active Ingredient
100-641
14.30
100-1178
Propiconazole: 11.70
Azoxystrobin: 7.00
100-1192
Propiconazole: 2.90
Chlorothalonil: 38.50
100-1216
Propiconazole: 9.54
Azoxystrobin: 5.73
100-1231
Propiconazole: 4.70
Chlorothalonil: 29.90
Fludioxonil: 1.20
100-1244
32.40
264-778
Propiconazole: 20.90
Trifloxystrobin: 25.00
264-779
Propiconazole: 11.40
Trifloxystrobin: 11.40
352-699
Propiconazole: 45.00
Fentin Hydroxide: 40.00
1022-585
Propiconazole: 3.00
IPBC: 6.00
1448-394
8.00
1448-414
Propiconazole: 5.00
Bardac2280: 25.00
5383-114
Propiconazole: 7.00
IPBC: 21.60
5383-120
Propiconazole: 6.00
IPBC: 17.40
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No Batch
EPA Reg. No.
Percent Active Ingredient
9198-227
Propiconazole: 0.62
Chlorothalonil: 3.90
PCNB: 7.50
57227-3
Propiconazole: 4.94
Bardac 2280: 46.25
57227-6
40.00
60061-102
10.00
60061-107
Propiconazole: 5.00
Bardac 2280: 46.25
60061-112
Propiconazole: 3.50
Diiodomethyl-p-tolyl sulfone: 0.95
IPBC: 3.50
60061-114
4.50
60061-115
Propiconazole: 0.977
IPBC: 0.979
Tebuconazole: 0.979
60061-121
Propiconazole: 5.00
IPBC: 5.00
70227-4
20.00
71711-17
Propiconazole: 6.00
Flutolanil: 32.00
71711-24
Propiconazole: 1.80
Chlorothalonil: 21.65
Flutolanil: 17.20
72616-1
Propiconazole: 5.00
IPBC: 5.00
Maquat: 50.00
75506-1
Propiconazole: 0.40
Boric Acid: 9.74
Copper Carbonate: 18.18
75506-7
Propiconazole: 5.00
Imidacloprid: 0.50
Tebuconazole: 5.00
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APPENDIX H: List of Registrants Sent the Generic
and Product-Specific DCIs for Propiconazole
This is a placeholder for the list of registrants sent the generic and product DCIs for
propiconazole. The final list of registrants will be compiled when the DCIs are issued
(at a future date).
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Appendix I: List of Available Related Documents
and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions:
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on
your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the following address for the Document Processing
Desk.:
Document Processing Desk (distribution code)*
Office of Pesticide Programs (7504P)
Environmental Protection Agency
1200 Pennsylvania Ave, NW
Washington, DC 20460-0001
* Distribution Codes are as follows:
(APPL) Application for product registration
(AMEND) Amendment to existing registration
(CAN) Voluntary Cancellation
(EUP) Experimental Use Permit
(DIST) Supplemental Distributor Registration
(SLN) Special Local Need
(NEWCO) Request for new company number
(NOTIF) Notification
(PETN) Petition for Tolerance
(XFER) Product Transfer
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. If you want these forms mailed or faxed to you,
please contact Lois White, white.lois@epa.gov or Floyd Gayles, gayles.floyd@epa.gov.
If you have any questions concerning how to complete these forms, please contact OPP's
ombudsperson for conventional pesticide products: Linda Arrington, (703) 305-5446
The following Agency Pesticide Registration Forms are currently available via the Internet at the
following locations:
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8570-1
Application for Pesticide
Registration/Amendment
http ://www. epa. gov/ opprdOO 1 /forms/8570-1. pdf
8570-4
Confidential Statement of Formula
http ://www. epa. gov/ opprdOO 1 /forms/8570-4. pdf
8570-5
Notice of Supplemental Registration of
Distribution of a Registered Pesticide
Product
http ://www. epa. gov/ opprdOO 1 /forms/8570-5. pdf
8570-17
Application for an Experimental Use
Permit
http ://www. epa. gov/ opprdOO 1 /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/ opprdOO 1 /forms/8570-25. pdf
8570-27
Formulator's Exemption Statement
http ://www. epa. gov/ opprdOO 1 /forms/8570-27. pdf
8570-28
Certification of Compliance with Data
Gap Procedures
http ://www. epa. gov/ opprdOO 1 /forms/8570-28. pdf
8570-30
Pesticide Registration Maintenance Fee
Filing
http ://www. epa. gov/ opprdOO 1 /forms/8570-3 0. pdf
8570-32
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
http ://www. epa. gov/ opprdOO 1 /forms/8570-32. pdf
8570-34
Certification with Respect to Citations of
Data (in PR Notice 98-5)
http://www.epa.gov/opppmsdl/PR Notices/pr98-
5.pdf
8570-35
Data Matrix (in PR Notice 98-5)
http://www.epa.gov/opppmsdl/PR Notices/pr98-
5.pdf
8570-36
Summary of the Physical/Chemical
Properties (in PR Notice 98-1)
http://www.epa.gov/opppmsdl/PR Notices/pr98-
l.pdf
8570-37
Self-Certification Statement for the
Physical/Chemical Properties (in PR
Notice 98-1)
http://www.epa.gov/opppmsdl/PR Notices/pr98-
l.pdf
Pesticide Registration Kit http ://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.
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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/opppmsd 1 /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.
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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 website.
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 website: http://npic.orst.edu
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
• Product Manager assignment
Other identifying information may be included by the applicant to link the acknowledgment of
receipt to the specific application submitted. EPA will stamp the date of receipt and provide
the EPA identifying File Symbol or petition number for the new submission. The identifying
number should be used whenever you contact the Agency concerning an application for
registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded
and assigned to your company, please include a list of all synonyms, common and trade
names, company experimental codes, and other names which identify the chemical (including
"blind" codes used when a sample was submitted for testing by commercial or academic
facilities). Please provide a CAS number if one has been assigned.
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