United States       Prevention, Pesticides    EPA738-R-98-019
        Environmental Protection   And Toxic Substances    November 1998
        Agency	(7508W)	
&EPA  Reregistration
        Eligibility Decision (RED)

        IPRODIONE

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                   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                    WASHINGTON, D.C. 20460
                                                                     OFFICE OF
                                                           PREVENTION, PESTICIDES
                                                           AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:

       I am pleased to announce that the Environmental Protection Agency has completed its
reregi strati on eligibility review and decisions on the pesticide chemical case Iprodione which
includes the active ingredients [enter chemical names here]. The enclosed Reregi strati on Eligibility
Decision (RED), which was approved on September 30, 1998 contains the Agency's evaluation
of the data base of these chemicals, its conclusions of the potential human health and
environmental risks of the current product uses, and its decisions and conditions under which
these uses and products will be eligible for reregistration. The RED includes the data and labeling
requirements for products for reregistration.  It may also include requirements for additional data
(generic) on the active ingredients  to confirm the risk assessments.

       To assist you with a proper response, read the enclosed document entitled "Summary of
Instructions for Responding to the RED." This summary also refers to other enclosed documents
which include further instructions.  You must follow all instructions and submit complete and
timely responses. The first set of required responses is due 90 days from  the receipt of this
letter.  The second set of required responses is due 8 months from the date of this letter.
Complete and timely responses will avoid the Agency taking the enforcement action of suspension
against your products.

       Please note that the Food Quality Protection Act of 1996 (FQPA) became effective on
August 3, 1996, amending portions of both pesticide law (FIFRA) and the food and drug law
(FFDCA).  This RED takes into account, to the extent currently possible, the new  safety standard
set by FQPA for establishing and reassessing tolerances. However, it should be noted that in
continuing to make reregistration determinations during the early stages of FQPA implementation,
EPA recognizes that it will be necessary to make decisions relating to FQPA before the
implementation process is complete.  In making these early case-by-case decisions, EPA does not
intend to set broad precedents for the application of FQPA. Rather, these early determinations

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will be made on a case-by-case basis and will not bind EPA as it proceeds with further policy
development and any rulemaking that may be required.

       If EPA determines, as a result of this later implementation process, that any of the
determinations described in this RED are no longer appropriate, the Agency will pursue whatever
action may be appropriate, including but not limited to reconsideration of any portion of this
RED.

       If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the Special Review and Reregi strati on Division representative  Frank
Rubis at (703) 308-8184. Address any questions on required generic data to the Special Review
and Reregi strati on Division representative Dennis Deziel at (703) 380-8173.

                                                       Sincerely yours,
                                                       Lois A. Rossi, Director
                                                       Special Review and
                                                        Reregi strati on Division
Enclosures

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               SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
              THE REREGISTRATION ELIGIBILITY DECISION (RED)

1  DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, a DCI letter will be enclosed describing such data.  If product specific data are
required, a DCI letter will be enclosed listing such requirements.  If both generic and product
specific data are required, a combined Generic and Product Specific DCI letter will be enclosed
describing such data. However, if you are an end-use product registrant only and have been
granted a generic data exemption (GDE) by EPA, you are being sent only the product specific
response forms (2 forms) with the RED. Registrants responsible for generic data are being sent
response forms for both generic and product specific data requirements (4 forms). You must
submit the appropriate response forms (following the instructions provided) within 90 days
of the receipt of this RED/DCI letter; otherwise, your product may be suspended.

2  TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions.  Requests for time extensions for product specific data should
be submitted in the 90-day response. Requests for data waivers must be submitted as part of the
90-day response. All data waiver and time extension requests must be accompanied by a full
justification. All waivers and time extensions must be granted by EPA in order to go into effect.

3  APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).

       a. Application for Reregistration (EPA Form 8570-1). Use only an original application
form. Mark it "Application for Reregistration."  Send your Application for Reregistration (along
with the other forms listed in b-e below) to the address listed in item 5.

       b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations  (40 CFR 156.10) and policies.  Submit any other amendments (such as formulation
changes, or labeling changes not related to reregi strati on) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregi strati on. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on Applying
for Registration in the U.S., Second Edition, August 1992" (available from the National Technical
Information Service, publication #PB92-221811; telephone number 703-487-4650).

       c. Generic or Product Specific Data  Submit all data in a format which complies with
PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRID) numbers. Before  citing these studies, you must make sure that they meet the
Agency's acceptance criteria  (attached to the DCI).

       d Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation.  The labeling and CSF which you submit for each product must

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comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
ง158.175) or (2) provide certified limits that are supported by the analysis of five batches.  If you
choose the second option, you must submit or cite the data for the five batches along with a
certification statement as described in 40 CFR ง158.175(e).  A copy of the CSF is enclosed;
follow the instructions on its back.

      e  Certification With Respect to Data Compensation Requirements Complete and
sign EPA form 8570-31 for each product.

4  COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.

5  WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)

By U.S. Mail:

      Document Processing Desk (RED-SRRD-PRB)
      Office of Pesticide Programs (7504C)
      EPA, 401 M St. S.W.
      Washington, D.C. 20460-0001

By express:

      Document Processing Desk (RED-SRRD-PRB)
      Office of Pesticide Programs (7504C)
      Room 266A, Crystal Mall 2
       1921 Jefferson Davis Hwy.
      Arlington, VA 22202

6.  EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data waiver
and time extension requests within 60 days. EPA will also try to respond to all 8-month
submissions with a final reregi strati on determination within 14 months after the RED has been
issued.

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REREGISTRATION ELIGIBILITY DECISION

                   Iprodione

                   LISTB

                  CASE 2335
            ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF PESTICIDE PROGRAMS
         SPECIAL REVIEW AND REREGISTRATION DIVISION

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                           TABLE OF CONTENTS



2335 REREGISTRATION ELIGIBILITY DECISION TEAM	i

I.     INTRODUCTION                                                          1

II.    CASE OVERVIEW                                                       2
      A.    Chemical Overview  	2
      B.    Use Profile                                                         2
      C.    Estimated Usage of Pesticide                                          7
      D.    Data Requirements                                                  8
      E.    Regulatory History                                                  8

III.   SCIENCE ASSESSMENT                                                  8
      A.    Physical and Chemical Properties Assessment                          8
      B.    Human Risk Assessment 	9
            1.     Hazard Assessment                                            9
                   a.     Toxicology Database                                    9
                   b.     Acute Toxicity                                          9
                   c.     Subchronic Toxicity                                    10
                   d.     Chronic Toxicity and Carcinogenicity                    11
                         (1)    Combined Chronic Toxicity/Carcinogenicity Study in
                               Rats  	11
                         (2)    Chronic Toxicity Study in Dogs  	12
                         (3)    Carcinogenicity Study in Mice 	13
                         (4)    Studies on Carcinogenicity Mechanism of Action ... 14
                   e.     Reproduction and Developmental Toxicity Studies	18
                         (1)    Two-Generation Reproduction Study in Rats  	18
                         (2)    Developmental Toxicity  Study in Rats  	18
                         (3)    Developmental Toxicity  Study in Rabbits  	19
                         (4)    Mutagenicity Studies                             20
                   f.      Gene Mutation                                        20
                   g.     Chromosomal Aberration Assay	20
                   h.     Other Genotoxic Effects                                20
                   i.      Metabolism  	21
                   j.      Dermal Penetration Study 	22
                   k.     Inhalation Toxicity 	22
            2.     Dose - Response Assessment	22
                   a.     Determination of Susceptibility to Infants and Children  ... 23
                         (1)    Neurotoxicity Data	23
                         (2)    Developmental Toxicity  Data  	23
                         (3)    Reproductive Toxicity Data  	24

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             (4)    Determination of Susceptibility                     24
             (5)    Recommendation  for  a Developmental  Neurotoxicity
                   Study  	24
             (6)    Determination of the FQPA Safety Factor           26
             (7)    Application of the FQPA Safety Factor              27
      b.     Toxicological Endpoints for Risk Assessment  	27
             (1)    Acute Dietary                                    27
             (2)    Chronic Reference Dose (RfD)                     29
             (3)    Carcinogenic Risk Assessment 	29
      c.     Occupational/Residential Exposure	30
             (1)    Short- and Intermediate-Term Dermal - (1 day to several
                   months)  	30
             (2)    Long-Term Dermal (Several Months to Life-Time)    30
             (3)    Dermal Absorption  	30
             (4)    Inhalation Exposure (Short and Intermediate-Term only)
                    	30
                   (a)    Short-Term Inhalation Exposure             31
                   (b)    Intermediate-Term Inhalation Exposure   .... 31
                   (c)    Long-Term Exposure	31
      d.     Target Margin  of  Exposure  for  Occupational/Residential
             Exposures	31
      e.     Recommendation for Aggregate Exposure Risk Assessments
              	31
3.     Occupational and Residential Exposure and Risk Assessment	32
      a.     Occupational-use sites	32
      b.     Residential-use sites  	33
      c.     Occupational Exposures & Risks	33
             (1)    Handler Exposures & Risks  	33
             (2)    Handler Exposure Scenarios	34
             (3)    Handler Exposure Scenarios — Data and Assumptions
                    	34
             (4)    Handler Exposure and  Non-Cancer Risk Estimates   . 35
      d.     Handler Exposure and Risk Estimates for Cancer  	44
             (1)    Summary of Risk Concerns for Handlers, Data Gaps, and
                   Confidence in Risk Estimates  	54
      e.     Occupational Post-Application Exposures and Risks        59
             (1)    Postapplication Exposure Scenarios                 59
             (2)    Data Sources and Assumptions for Scenarios Considered
                    	61
             (3)    Postapplication Exposure and Non-Cancer Risk Estimates
                    	65
             (4)    Postapplication Exposure and Risk Estimates for Cancer
                    	66
             (5)    Data Gaps, Quality, and Confidence                68

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      (6)    Residential and other Non-occupational Exposures and
             Risks	69
      (7)    Residential Handler Exposure and Risk  Estimates for
             Cancer 	71
f.     Summary of Risk Concerns for Homeowner-Handlers, Data
      Gaps, and Confidence in Exposure and Risk Estimates .... 71
      (1)    Non-Occupational Postapplication Exposures and Risks
              	74
      (2)    Postapplication Exposure and Non-Cancer Risk Estimates
              	76
      (3)    Postapplication Exposure and Risk Estimates for Cancer
              	77
      (4)    Summary of  Postapplication  Risks, Data Gaps, and
             Confidence	77
g.     Incident Reports                                        78
h.     Dietary Exposure and Risk Assessment/Characterization    82
      (1)    Dietary Exposures from Food Sources               82
             (a)    GLN 860.1200: Directions for Use            82
             (b)    GLN 860.1300: Nature of the Residue - Plants
              	82
             (c)    GLN 860.1300: Nature of the Residue - Animals
              	82
             (d)    GLN 860.1340: Residue Analytical  Methods   83
             (e)    GLN 860.1360: Multiresidue Methods        84
             (f)    GLN 860.1380: Storage Stability Data        84
             (g)    GLN 860.1500: Crop Field Trials             85
             (h)    GLN 860.1520: Processed Food/Feed         85
             (i)    GLN 860.1480: Meat, Milk, Poultry, and Eggs
                    	85
             (j)    GLN 860.1400: Water, Fish, and Irrigated Crops
                    	86
             (k)    GLN 860.1460: Food Handling               86
             (1)    GLN   860.1850:  Confined  Accumulation  in
                   Rotational Crops  	86
             (m)   GLN 860.1900: Field Accumulation in Rotational
                   Crops  	86
      (2)    Dietary Risk Assessment/Anticipated Residues       92
      (3)    Exposure and Risk From Food Sources              92
             (a)    Acute Dietary Risk (Tier 1/2/3/4)             92
      (4)    Chronic, Non-Carcinogenic Risk (TMRC and ARC)
              	93
      (5)    Chronic, Carcinogenic Risk (ARC)                 93
      (6)    Drinking Water Exposure	94
             (a)    Ground Water (modeling/monitoring)        94
      (7)    Surface Water (modeling/monitoring)               95

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                                                                          97








4.






i.







\ / C3
Food Quality Protection Act Considerations
(1) Cumulative Risk for 3,5-Dichloroaniline 	
(2) Iprodione-derived 3,5-DCA residues in food
(3) Vinclozolin-derived 3,5-DCA residues in food
(4) Procymidone-derived 3,5-DCA Residues in Wine .
(5) 3,5-DCA Residues in Water from Iprodione
(6) 3,5-DCA Residues in Water from Vinclozolin
(7) Cumulative Risk from all sources of 3,5-DCA ....
Aggregate Exposure and Risk Assessment/Characterization
a.
b.
c.
d.
e.

Acute Aggregate Risk
Chronic Aggregate Risk
Cancer Aggregate Risk
Short-term Aggregate Risk
Intermediate-term Aggregate Risk
(1) Endocrine Disruption 	
ENVIRONMENTAL RISK ASSESSMENT
100
. 100
. 101
. 102
. 102
. 103
. 103
. 104
. 105
105
105
106
106
107
110
110
C.
      1.     Environmental Fate Assessment                                110
             a.     Degradation and Metabolism                            111
                   (1)    Chemical Degradation                            111
                   (2)    Microbial Degradation                           111
                   (3)    Mobility	112
                   (4)    Field Dissipation                                 112
                   (5)    Accumulation                                   113
                   (6)    Spray Drift                                     113
                   (7)    Terrestrial Exposure Assessment                  113
                   (8)    Water Resource Assessment                       114
                         (a)   Ground Water Assessment                 114
                         (b)   Surface Water Assessment                 115
                         (c)   Drinking Water Assessment  	117
                         (d)   Ground Water Sources                     117
                         (e)   Surface Water Sources                     118
                   (9)    Use   of  Screening  Estimates   for  Drinking  Water
                         Assessments  	119
      2.     Ecological Effects Hazard Assessment	119
                   (1)    Toxicity to Terrestrial Animals	120
                         (a)   Birds, Acute and Subacute 	120
                         (b)   Birds, Chronic                            120
                   (2)    Mammals, Acute and Chronic  	121
                         (a)   Insects	121
                   (3)    Toxicity to Freshwater  Aquatic Animals  	122
                         (a)   Freshwater Fish, Acute                     122
                         (b)   Freshwater Fish, Chronic                  122
                         (c)   Freshwater Invertebrates, Acute	123
                         (d)   Freshwater Invertebrate, Chronic	123

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                          (4)    Toxicity to Estuarine and Marine Animals  	123
                                (a)    Estuarine and Marine Fish, Acute           123
                                (b)    Estuarine and Marine Fish, Chronic	124
                                (c)    Estuarine and Marine Invertebrates, Acute
                                 	124
                                (d)    Estuarine and Marine Invertebrate, Chronic
                                 	124
                                (e)    Freshwater and Estuarine Field Studies      124
                          (5)    Toxicity to Plants                                125
                                (a)    Terrestrial                                125
                                (b)    Aquatic Plants                             125
             3.     Ecological Risk Assessment 	126
                          (1)    Exposure and Risk to Nontarget Terrestrial Animals
                                 	126
                                (a)    Birds	126
                                (b)    Birds-Chronic Risks                       128
                                (c)    Mammals-Acute Risks                     129
                                (d)    Mammals-Chronic  Risks  from  Nongranular
                                      Products                                  132
                                (e)    Insects	132
                          (2)    Exposure and Risk to  Nontarget Freshwater  Aquatic
                                Animals  	133
                                (a)    Freshwater Fish                            134
                                (b)    Freshwater Invertebrates                   135
                          (3)    Exposure and Risk to Estuarine and Marine        135
                                (a)    Fish	135
                                (b)    Invertebrates                              136
                          (4)    Exposure and Risk to Nontarget Plants             136
                                (a)    Aquatic Plants                             136
                                (b)    Exposure and Risk to Endangered Species    137
                   4.     Risk Characterization	138

IV.   RISK MANAGEMENT AND REREGISTRATION DECISION                139
      A.     Determination of Eligibility	139
             1.     Eligibility Decision                                            140
             2.     Eligible and Ineligible Uses                                     140
      B.     Regulatory Position  	141
             1.     Food Quality Protection Act Findings                           141
                   a.     Determination of Safety for U.S. Populations  	141
                   b.     Determination of Safety for Infants and Children	144
             2.     Risk Mitigation                                               145
             3.     Tolerance Reassessment Summary  	148
             4.     Codex Harmonization  	154
             5.     Reference Dose (RfD)                                          155
             6.     Cancer Risk Assessment	155

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             7.     Endocrine Disruption	155
             8.     Occupational Exposure                                       156
                   a.     Handler Exposure and Risk                            156
                   b.     Post-Application Exposure and Risk                     157
                   c.     Other Labeling Requirements 	158
             9.     Ecological Effects Risk Management	158
             10.    Spray Drift Advisory                                         159
             11.    Endangered Species Program                                 159

V.    ACTIONS REQUIRED OF REGISTRANTS                                159
      A.     Manufacturing-Use Products	160
             1.     Additional Generic Data Requirements	160
             2.     Labeling Requirements for Manufacturing-Use Products  	162
      B.     End-Use Products                                                  162
             1.     Additional Product-Specific Data Requirements  	162
             2.     Labeling Requirements for End-Use Products  	163
                   a.     PPE and  Engineering Control  Requirements for Pesticide
                         Handlers  	163
                   b.     Products Intended Primarily for Occupational Use        163
                         (1)    Active-Ingredient    Specific   Engineering   Control
                               Requirements   	163
                         (2)    Active-Ingredient Specific Personal Protective Equipment
                               Requirements	164
                   c.     Determining PPE Labeling Requirements for End-use Products
                         Containing This Active Ingredient	166
                   d.     Products intended for Residential Use	166
                   e.     Placement in Labeling	166
                   f.     Entry Restrictions	166
                   g.     Products Intended Primarily for Occupational Use	166
                   h.     Spray Drift Labeling                                   169
      C.     Existing Stocks	179

VI. APPENDICES                                                            181
      A.     Table of Use Patterns Subject to Reregistration                        182
      B.     Table of the Generic Data  Requirements and Studies Used to Make the
             Reregistration Decision  	183
      C.     Citations Considered to be Part of the Data Base Supporting the Reregistration
             Decision	188
      D.     Generic Data Call-In                                               205
             1.     Generic Data Call-In Chemical Status Sheet                    222
             2.     Generic DCI Response Forms Inserts (Insert A) plus Instructions
                    	223
             3.     Requirements Status and Registrants' Response Forms (Insert B) plus
                   Instructions	227
      E.     Product Specific Data Call-In                                       235

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      1.     Product Specific Chemical Status Sheets                        247
      2.     Data Call-in Response Form for the Product Specific Data(Form A
             inserts) Plus Instructions  	250
      3.     Product Specific Requirement Status and Registrant's Response Forms
             (Form B inserts) and Instructions  	252
      4.     EPA Batching of End-Use Products for Meeting Data Requirements for
             Reregistration	259
      5.     List of All Registrants  Sent This Data Call-In (insert) Notice      262
F.    List of Available Related Documents and Electronically Available Forms
        	263

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2335 REREGISTRATION ELIGIBILITY DECISION TEAM

Office of Pesticide Programs:

Biological and Economic Analysis Assessment
Alan Halvorson
Leo Lasota
Economic Analysis Branch
Biological Analysis Branch
Environmental Fate and Effects Risk Assessment
Dana Spatz
Jose Melendez
Ann Stavola
Sid Abel

Health Effects Risk Assessment

Christina Scheltema
William Smith
Kelly O'Rourke
Linda Taylor
Jerome Blondell

Registration Support Risk Assessment

Carl Grable

Risk Management
Environmental Risk Branch 4
Environmental Risk Branch 4
Environmental Risk Branch 4
Environmental Fate and Monitoring Branch
Risk Characterization and Analysis Branch
Chemistry and Exposure Branch 1
Occupational and Residential Exposure Branch
Reregi strati on Action Branch 2
Chemistry and Exposure Branch 2
Fungicide-Herbicide Branch
Dennis Deziel
Reregi strati on Branch 1

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               GLOSSARY OF TERMS AND ABBREVIATIONS

ADI           Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE            Acid Equivalent
a.i.            Active Ingredient
ARC           Anticipated Residue Contribution
CAS           Chemical Abstracts Service
CI             Cation
CNS           Central Nervous System
CSF           Confidential Statement of Formula
DFR           Dislodgeable Foliar Residue
ORES          Dietary Risk Evaluation System
DWEL         Drinking Water Equivalent Level (D WEL) The DWEL represents a medium specific (i.e. drinking
               water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
               occur.
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
FAO/WHO     Food and Agriculture Organization/World Health Organization
FDA           Food and Drug Administration
FIFRA         Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA        Federal Food, Drug, and Cosmetic Act
FQPA          Food Quality Protection Act
FOB           Functional Observation Battery
GLC           Gas Liquid Chromatography
GM           Geometric Mean
GRAS          Generally Recognized as Safe as Designated by FDA
HA            Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
               organizations when emergency spills or contamination situations occur.
HOT           Highest Dose Tested
LC50           Median Lethal Concentration. A statistically derived concentration of a substance that can be
               expected to cause death in  50% of test animals. It is usually expressed as the weight of substance
               per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50           Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
               of the test animals when  administered by the route indicated (oral, dermal, inhalation).  It is
               expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo           Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL           Lowest Effect Level
LOG           Level of Concern
LOD           Limit of Detection
LOEL          Lowest Observed Effect Level
MATC         Maximum Acceptable Toxicant Concentration
MCLG         Maximum Contaminant Level Goal (MCLG)   The MCLG is used by the Agency to regulate
               contaminants in drinking water under the Safe Drinking Water Act.
ug/g           Micrograms  Per Gram
/-ig/L           Micrograms  per liter
mg/L           Milligrams Per Liter
MOE           Margin of Exposure
MP            Manufacturing-Use Product
MPI           Maximum Permissible Intake
                                                 ill

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MRID          Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A           Not Applicable
NOEC         No Observable Effect Concentration
NPDES        National Pollutant Discharge Elimination System
NOEL         No Observed Effect Level
NOAEL        No Observed Adverse Effect Level
OP            Organophosphate
OPP           Office of Pesticide Programs
Pa             pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
PADI          Provisional Acceptable Daily Intake
PAG           Pesticide Assessment Guideline
PAM          Pesticide Analytical Method
PHED          Pesticide Handler's Exposure Data
PHI           Preharvest Interval
ppb            Parts Per Billion
PPE           Personal Protective Equipment
ppm           Parts Per Million
PRN           Pesticide Registration Notice
Q*!            The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC           Red Blood Cell
RED           Reregistration Eligibility Decision
REI           Restricted Entry Interval
RfD           Reference Dose
RS            Registration Standard
RUP           Restricted Use Pesticide
SLN           Special Local Need  (Registrations Under Section 24 (c) of FIFRA)
TC            Toxic  Concentration. The concentration  at which a substance produces a toxic effect.
TD            Toxic Dose. The dose at which a substance produces a toxic effect.
TEP           Typical End-Use Product
TGAI          Technical Grade Active Ingredient
TLC           Thin Layer Chromatography
TMRC         Theoretical Maximum Residue Contribution
torr            A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
WP            Wettable Powder
WPS           Worker Protection Standard
                                                 IV

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EXECUTIVE SUMMARY

       The U. S. Environmental Protection Agency has completed its reregi strati on eligibility
decision  (RED)  of the pesticide  iprodione.  This  decision  includes a  comprehensive
reassessment of the required target data and the use patterns of currently registered products.

       Iprodione is a contact and/or locally systemic fungicide registered for use on a variety
of field, fruit, and vegetable crops. These end-use patterns for the current formulations have
been classified for outdoor use only, and applications include aircraft (fixed-wing and
helicopter), airblast sprayer, chemigation, groundboom, drench, in furrow spray planter, high-
and low-pressure handwand, backpack sprayer, tractor-drawn spreader,  push-type lawn
spreader, and garden hose-end sprayer. It is formulated as a liquid, dry flowable, wettable
powder, and granular. Rhone-Poulenc, Inc., is supporting the reregistration of iprodione.

       The Agency has concluded that most uses, as prescribed in this document, will not
cause unreasonable risks to humans or the environment, subject to conditions imposed in this
RED. Based on cancer risk concerns, the Agency has determined that iprodione residential
uses on turf, ornamentals and vegetable/small fruit gardens are ineligible for reregistration.
The registrant, Rhone-Poulenc, has requested to voluntary cancelation of all residential uses
of iprodione.  Furthermore, Rhone Poulenc has requested to voluntary cancelation of the
application of iprodione using a belly grinder, which posed an unacceptable risk to handlers.

       In addition, to reduce acute dietary risk and dietary cancer risk concerns posed by the
use of iprodione, Rhone-Poulenc has voluntarily agreed to a number of risk mitigation
measures: (1) increase the pre-harvest interval on all stone fruit uses from 7-days to up to but
no later than petal fall; (2) increase the pre-harvest interval for strawberry uses from 0-days
to up to but no later than first flower; and, (3) reduce the number of applications of iprodione
on table grapes (includes grapes for juice and raisins, but not wine and sherry grapes) from
four applications per season to one application early- to mid-bloom. Also, the tolerance for
iprodione on all stone fruit and strawberries will be reduced to the limit of quantitation (0.05
ppm).

       With these risk mitigation measures in place, the acute dietary risk from iprodione is
within the range the Agency considers acceptable (MOE = 351), as is the aggregate cancer
risk(1.8xlO-6).

       The Agency found that the toxicity data base for iprodione is complete, based on
current requirements.  The Agency has concluded  that iprodione is  a  B2, or "likely"
carcinogen.  In reaching the determination of safety  for infants and children as mandated by
the Food Quality and Protection Act  (FQPA), the  Agency has concluded that the FQPA
safety factor will be applied for: 1) acute dietary risk assessment of females 13+ because the
toxicology endpoint is based on an in utero effect;  2) for a chronic dietary risk assessment
for the general population including infants and children because the endpoint is based on
male reproductive toxicity; and, 3) for residential exposure risk assessments for the general

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population including infants and children since the use pattern indicate potential exposure by
all population subgroups.

       In examining aggregate exposure, FQPA directs the Agency to take into account
available information concerning exposures  from pesticide residues  in  food and other
exposures for which there is reliable information.  Estimated average concentrations of
iprodione in ground water are not currently available for comparison against drinking water
level of concern values; however, based on iprodi one's physical/chemical characteristics and
available, but limited, monitoring data, iprodione is not expected to significantly impact
ground water, and is expected to be below the Agency's level of concern for surface water.
However, iprodione is a B2 carcinogen with both residential and food uses. The aggregate
cancer risk estimate, before risk mitigation, exceeds the Agency' s threshold target/goal of 10"6
for a number of dietary/residential scenarios.  In order to be reregistered, all residential uses
must be removed from iprodione product labels (see above).

       The Agency does not have, at this time, available data to determine whether iprodione
has a common mechanism of toxicity with other substances or how to include this pesticide
in a cumulative risk assessment. For the purposes of this reregi strati on decision, the Agency
has not assumed that iprodione has a common mechanism of toxicity with other substances.

       Because  of potential effect to non-target organisms in ecological  systems from
iprodione, the Agency is including additional label warnings for iprodione manufacturing and
end-use products.  These mitigation measures include a 25-foot vegetative buffer strip for
application of iprodione adjacent to water bodies, and a limit for the maximum number of
applications on turf, lawn, golf course, ornamental trees  and  plants from an "unlimited"
unspecified number of applications to a maximum to 6 per year.

       Before reregistering the products containing iprodione, the Agency is requiring that
product specific data, revised Confidential Statement of Formula (CSF) and revised labeling
be submitted within eight months of the issuance  of this document.   These data include
product chemistry for each registration and acute toxicity testing. After reviewing these data
and any revised labels and finding them acceptable in accordance with Section 3(c)(5) of
FIFRA, the Agency will reregister a product.  Those products which contain other active
ingredients will be eligible for reregi strati on only when  the other active ingredients are
determined to be eligible for reregi strati on.
                                     VI

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I.      INTRODUCTION

              In 1988, the  Federal Insecticide, Fungicide,  and Rodenticide Act (FIFRA) was
       amended to accelerate the reregistration of products with active ingredients registered prior
       to November 1, 1984. The amended Act provides a schedule for the reregistration process
       to be completed in nine years. There are five phases to the reregistration process. The first
       four phases of the process focus on identification of data requirements to support the
       reregistration of an active ingredient and the generation and submission of data to fulfill the
       requirements. The fifth phase is a review by the U.S. Environmental Protection Agency
       (referred to as "EPA" or the Agency") of all data submitted to support reregistration.

              FIFRA Section 4(g)(2)(A) states that in Phase  5 "the Administrator shall determine
       whether pesticides containing such active ingredient are eligible for reregistration" before
       calling in data on products and  either reregistering products or taking "other appropriate
       regulatory action." Thus, reregistration involves a thorough review of the scientific data base
       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 the
       pesticide meets the "no unreasonable adverse effects" criterion of FIFRA.

              On August 3, 1996, the Food Quality and Protection Act of 1996 (FQPA) (Public
       Law 104-170) was signed. FQPA amends both the Federal Food, Drug, and Cosmetic Act
       (FFDCA), 21 U.S.C. 301 etseq., and the Federal Insecticide, Fungicide, and Rodenticide Act
       (FIFRA), 7 U.S. C. I36etseq..  The FQPA amendments went into effect immediately.  Asa
       result, EPA is embarking on an intensive process, including consultation with registrants,
       States, and  other  interested stakeholders, to make  decisions  on the new policies and
       procedures that will be appropriate as a result of enactment of FQPA.  This process will
       include a more in-depth analysis of the new safety standard and how it should be applied to
       both food and non-food pesticide applications. The FQPA did not, however, amend any of
       the  existing reregistration deadlines in  section 4 of FIFRA. The Agency will, therefore,
       continue its ongoing reregistration program while it determines how best to implement FQPA.

              This document presents the Agency's decision regarding the reregistration eligibility
       of the registered uses of iprodione . The document consists of six sections. Section I is the
       introduction. Section II describes iprodione, its uses, data requirements and regulatory
       history. Section III discusses the human health and environmental assessment based on the
       data available to the Agency. Section IV presents the reregistration decision for iprodione .
       Section V discusses the reregistration requirements for iprodione. Finally, Section VI is the
       Appendices  which support  this Reregistration Eligibility Decision.  Additional  details
       concerning the Agency's review of applicable data are  available on request.

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II.     CASE OVERVIEW

       A.    Chemical Overview

             The following  active ingredient(s) are covered by this Reregi strati on Eligibility
       Decision:

       !      Common Name:           Iprodione

       !      Chemical Name:           [3-(3,5-dichlorophenyl)-N-(l-methylethyl)-2,4-dioxo-
                                        1 -imidazolidinecarboxamide]

       !      Chemical Family:          imide

       !      CAS Registry Number:    36734-19-7

       !      OPP Chemical Code:      109801

       !      Empirical Formula:        C13H13C12N3O3

       !      Trade and Other Names:   Chipco
                                        Rovral
                                        Kidan

       !      Basic Manufacturer:       Rhone-Poulenc


       B.    Use Profile

             The following is information on the currently registered uses with an overview of use
       sites and application methods. A detailed table of these uses of iprodione is in Appendix A.
       Due to the length of Appendix A (over 100 pages),  copies are available separately upon
       request per the instructions in Appendix E.

             For iprodione:

             Type of Pesticide:    fungicide

             Use Sites:

             •      Agricultural Crops, including almonds, apricots, cherries, nectarines, peaches,
                    pecans, plums, prunes, beans (dried, lima, and snap), blackberries, blueberries,
                    broccoli,  bushberries,   caneberries,  carrots,  garlic,  grapes,  ginseng,

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       gooseberries, huckleberries, lettuce (head and leaf), loganberries, mustard
       cabbage, Chinese cabbage, dry bulb onions, peanuts, potatoes, raspberries,
       and strawberries.

•      Ornamentals, including flowering trees and shrubs, woody shrubs and vines,
       evergreens, flowering and nonflowering plants, ground covers and shade
       trees.

•      Turfgrass, including sod farms, golf courses and institutional lawn areas of
       bentgrass,  blue grass,  Bermuda grass, St. Augustine grass, rye grass, fine
       fescue or tall fescue.

•      Fruit/Nut Trees,  including almonds, apricots, cherries, nectarines, peaches,
       and plums.

•      SmallFruit/Vegetable Garden Crops, including beans (dried, lima, and snap),
       blackberries, blueberries, broccoli, bushberries, caneberries, carrots, garlic,
       grapes,  ginseng, gooseberries, huckleberries,  lettuce  (head  and  leaf),
       loganberries, mustard cabbage, Chinese cabbage, dry bulb onions, peanuts,
       potatoes, raspberries, and strawberries.

•      Ornamentals at Residences, including shade trees, evergreens and flowering
       and non-flowering shrubs.

•      Turfgrass, including residential lawn areas.

Target Pests:

       Type of fungi that iprodione is used to prevent, treat, and control include (but
are not limited to) the following (USEPA 1997c):

•      Dollar spot (Lanzia spp. andMoellerodiscus spp.), Brown patch (Rhizoctonia
       solani), Leaf spot and Melting out (Drechslera spp.)  ,  Fusarium blight
       (Fusarium  spp.), Gray snow mold (Typhula spp.) and  Pink snow  mold
       {Fusarium nivale), Corticum red thread (Laetisariafuciformis) on turfgrass;

•      Aerial web blight (Rhizoctonia sp.), Alternaria leaf blight (Alternariazinniae),
       Botrytis blight (Botrytis sp.), Ink  spot  (Drechslera iridis),  Ray blight
       (Ascochyta chrysanthami), Tulip fire (Botrytis tulipae), and Fusarium corn rot
       (Fusarium oxysporum) on ornamentals;

•      Sclerotinia blight (Sclerotinia minor} on peanuts;

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•      Sheath blight (Rhizoctonia solani), Brown spot (Bipolaris oryzai), Sheath
       spot (Rhizoctonia oryzae) and Narrow brown leaf spot (Cercospora oryzae)
       on rice;

•      Brown rot blossom blight (Monilinia spp.), Fruit brown rot (Monilinia spp.),
       Shot hole (Stigmina carpophila), Scab (Ventura carpophild), and Cherry leaf
       spot (Blumeriella jaapif) on stone fruit;

•      Bunch rot (Botrytis cinered) on grapes;

•      Gray mold  (Botrytis cinered), White  mold (Sclerotinia sclerotioruni) on
       beans,  Black leg (Leptosphaeria maculans) on broccoli, Alternaria blight
       (Alternaria daucf) and Black crown  rot (Alternaria radicind) on carrots,
       White rot (Sclerotium cepivoruni) on garlic, Lettuce drop (Sclerotinia spp.)
       and Brown rot (Rhizoctonia solani) on lettuce, and Early blight (Alaternaria
       solani) and White mold (Sclerotinia sclerotiorum) on potatoes.

Formulation Types Registered:

       TECHNICAL GRADE ACTIVE INGREDIENT:   95 percent;
•      Liquid soluble concentrate (14 and 41.6 percent active ingredient);
       Wettable powder (33.3 and 50 percent active ingredient);
•      Dry flowable (50 percent active ingredient);
       Flowable concentrate (41.6 percent active ingredient);
•      Emulsifiable concentrate (19.65, 23.3, and 50 percent active ingredient);
       Granular (1.02 and 1.3 percent active ingredient).

Method and Rates of Application:

Application Rates:

•      Commercial  Agricultural Crops: The  maximum  application  rate  for
       commercial crops ranges from 0.5 Ib ai/acre to 1.0 Ib ai/acre for all application
       methods.

•      Commercial Ornamentals: The maximum application rate for pre-planting
       and cold storage dip treatments ranges from 0.005 to 0.01 Ib ai/gallon.  The
       maximum  application rate  for  other application methods applicable to
       greenhouse treatments range from 0.002 to 0.01 Ib ai/gallon. The maximum
       rates for field nursery application range from 1.4 to 4 Ib ai/acre.

•      Commercial/Residential Turfgrass: Using granular, dry flowable and liquid
       formulations, the maximum application rate applied to sod farms, golf courses
       and institutional and residential lawns ranged from 1.4 to 5.5 Ib ai/acre.

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       Granular formulations are to be applied using a light rate (1.4 Ib ai/acre) to
       prevent certain fungi such as pink or gray snow mold or leaf spot.  A normal
       (2.7 Ib ai/acre) to heavy application rate (4.1 Ib ai/acre) is recommended to
       control fungi such as leaf spot, brown patch and red leaf spot (EPA Reg. No.
       538-159).

•      Residential Fruit and Nut Trees: The maximum application rates range from
       0.0013 to 0.0026 Ib ai/gallon for foliar spray to fruit/nut trees.

•      Residential Fruit/Vegetable Garden Crops:  The maximum application rate
       ranges from 0.0052 to 0.104 Ib ai/gallon.

•      Ornamentals at Residences: The maximum application rates vary from 0.002
       to 0.01 Ib ai/gallon.

Methods and Types of Equipment used for Mixing, Loading, and Application:

•      Commercial Agricultural Crops: Equipment includes aircraft (fixed-wing and
       helicopter), airblast sprayer for orchards, chemigation, groundboom, drench,
       in furrow spray planter, and high pressure handwand.  Seeds can be treated
       in slurry form or in a seed soaker.  Additionally, a dip treatment may be used
       before cold storage or as a pre-planting preventive measure on strawberries.

•      Commercial Ornamentals:  Equipment used on nursery and green house
       stock includes high pressure handwand, low pressure handwand,  backpack
       sprayer,  chemigation  systems,  groundboom  spray,  drench  and  low
       pressure/high volume handgun. Additionally, a dip treatment may be used
       before cold storage or as  a  pre-planting preventive measure on certain
       ornamental stock, including roses, gladiolus and azaleas.

•      Commercial/Residential Turfgrass: Granular application to turfgrass areas
       involves the use of a tractor-drawn spreader, belly grinder, push type lawn
       spreader, or hand application of granules for  spot treatment.  Liquid and
       wettable powder formulations can be applied to turfgrass sod farms, using
       chemigation systems, aircraft (fixed-wing or helicopter), groundbooms, low
       pressure/high volume  handguns,  low pressure handwands,  high pressure
       handwands, and backpack sprayers. These same formulations can be applied
       to other turf areas such as institutional areas,  golf courses and residential
       lawns.

•      Residential Fruit and Nut Trees:  Equipment for residential application
       includes backpack sprayers, low pressure handwands, and garden hose-end
       sprayers.

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             Residential Fruit/Vegetable  Garden Crops:   Equipment for  residential
             application includes low pressure handwands, backpack sprayers, garden
             hose-end sprayers.  Other possible application methods include dipping for
             cold storage or pre planting and seed soaking.

             Ornamentals  at Residences:   Ornamentals may be  treated  using  a low
             pressure handwand, backpack sprayer, or a garden hose-end sprayer.
Table 1. Main A
Crop
Peanuts
Almonds
Grapes
Peaches
Potatoes
Onions
Strawberries
Cotton
Turf - South
Turf - North
pplication Methods for Iprodione
Application Rate
(Ibs)
1
0.5
1
1
1
0.75
1
0.15
5.45
5.45
Number of
Applications
3
4
4
4
4
5
4
1
26
13
Application
Interval (days)
14
14
14
7
10
7
10
NA
14
14
Main Application
Method
Ground
Air
Ground
Air
Air
Air
Ground
Ground
Ground
Ground
Timing and Frequency of Applications:
              Commercial Agricultural Crops: The maximum number of applications per
              season applied to commercial agricultural crops ranges from 1 (e.g., dip, in
              furrow spray at planting,  post harvest spray to fruit, and  seed soak or
              treatment) to 10 per season for crops such as carrots, dry bulb onions, and
              strawberries.  Typically, the applications made 10 times per season  (e.g.,
              strawberries) are applied using one half the application rate of that for sites
              where the maximum number of applications is 4 times per year. Application
              intervals range from 7-21 days.

              Commercial Ornamentals:  Foliar spray applications to ornamental crops can
              be sprayed to runoff at 7-14 day intervals for an unspecified maximum number
              of applications per season.  Dip treatments to bare root roses, cuttings prior
              to planting, and corns prior to storage are applied  only  once per season.
              Drench treatments at seeding and/or after transplanting can be made at 14 day
              intervals.

              Commercial/Residential Turfgrass:  Iprodione labels state that applications
              to turfgrass may be made at  7-30 day intervals an unspecified number of times
              per season, or as  stated on  some labels "as required"(e.g., EPA Reg. No.
              264-562).

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       •      Residential Fruit and Nut Trees: Iprodione labels call for a maximum of 5
              applications per season at intervals of 7-14 days for stone fruit trees (e.g.
              apricots, nectarines, cherries, peaches, plums and prunes). A maximum of 4
              applications per year can be made to almond trees at pink  bud and if
              conditions  are  favorable for disease development, up to 3  subsequent
              applications can be made at: 1) full bloom, 2) petal fall, and 3) up to 5 weeks
              after petal fall.

       •      Residential Fruit/Vegetable Garden Crops: A maximum of 10 applications
              can be made to  strawberries and dry bulb onions at 7-14 day intervals. The
              maximum number of applications per season for other vegetables ranges from
              2 (e.g., broccoli and beans) to 4 (e.g., potatoes, carrots and caneberries), all
              applied at 7-14  day intervals.

       •      Ornamentals at Residences:  Residential rate frequency  and  application
              intervals are the same as for commercial ornamental applications.

C.     Estimated Usage of Pesticide

       This section summarizes  the best estimates  available for the pesticide uses of
iprodione.  These estimates are derived from a variety of published and proprietary sources
available to the Agency.  The  data, reported on an aggregate and site (crop) basis, reflect
annual fluctuations in use patterns  as well as the variability in using data from various
information sources.

       An estimated 930,000 to 1,730,000 pounds a.i. of iprodione are applied annually in
the U.S., with usage appearing to be fairly stable over the past few years. Much of this usage
is in agriculture.  Applications include about 75,000 to 205,000 pounds a.i. to almonds,
80,000 to 125,000 pounds a.i.  to grapes, 50,000 to 65,000 to peaches, 55,000 to 215,000
pounds a.i. to potatoes and 65,000 to 145,000 pounds a.i. to rice. These five crops account
for about 35 to 44 percent of the total pounds a.i. applied. Other sites treated include berries,
carrots, golf courses, lawns, lettuce, ornamentals, onions, peanuts, pistachios and other stone
fruit.

       Crops  with the  highest percentage of acreage  treated  are apricots  (70-85%),
raspberries (45-57%), almonds (30-60%), strawberries (32-50%) and carrots (17-50%).

Table 2.  Iprodione Major Use Information
Crop
Almonds
Grapes
Peaches
Potatoes
Rice
Pounds Iprodione per Year
75,000 to 205,000
80,000 to 125,000
50,000 to 65,000
55,000 to 215,000
65,000 to 145,000

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       D.    Data Requirements

             Appendix B includes all data requirements identified by the Agency for currently
       registered uses needed to support reregi strati on.

       E.    Regulatory History

             Iprodione was registered in the United States in 1979 for use as a fungicide. A Data
       Call-in was issued in September 1991 for iprodione.  The iprodione Phase 4 Review dated
       3/15/91 required additional generic and product-specific product chemistry data for the
       Rhone-Poulenc 95% T/TGAI.  Data submitted concerning GLNs 63-7 and 63-9 (OPPTS
       830.7300 and 830.7950) were found to be adequate for Phase 5 review; Rhone-Poulenc
       committed to conduct new studies concerning the remaining guideline requirements.

             Adequate data concerning the potential for formation of polyhalogenated dibenzo-p.-
       dioxins and/or polyhalogenated dibenzofurans during the manufacture of iprodione have been
       submitted.   The Agency has concluded that reaction conditions  are not favorable to
       dioxin/dibenzofuran   formation,   and  that   trichlorophenols  (TCDD  precursor),
       tetrachlorophenols, or other highly chlorinated impurities are not probable impurities.

             This reregi strati on eligibility decision reflects a reassessment of all data which were
       submitted in response to the Data Call-In.  Prior to completion of this RED document,
       Rhone-Poulenc requested  changes to its  iprodione product registrations to mitigate
       unacceptable dietary, worker, and ecological risk.
III.    SCIENCE ASSESSMENT

       A.    Physical and Chemical Properties Assessment

             Iprodione   [3-(3,5-dichl or ophenyl)-N-(l-methyl ethyl)-2,4-dioxo-1-
       imidazolidinecarboxamide] is a contact and/or locally systemic fungicide registered for use
       on a variety of field, fruit, and vegetable crops.

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                    Empirical Formula:
                    Molecular Weight:
                    CAS Registry No.:
                    Shaughnessy No.:
                                         C13H13C12N303
                                         330.17
                                         36734-19-7
                                         109801
       Iprodione  is a white odorless crystalline solid with a melting point of -128 C.
Iprodione is soluble in dichloromethane (45 g/100 mL), acetone (34 g/100 mL), ethyl acetate
(23 g/100 mL), acetonitrile (17 g/100 mL),  and toluene (15 g/100 mL), but is practically
insoluble in water (13 mg/L).  Iprodione is stable under normal storage conditions.
B.
Human Risk Assessment
       1.
       Hazard Assessment
              a.      Toxicology Database

       There are no data gaps for the standard Subdivision F Guideline requirements for a
food-use chemical by 40 CFR Part 158.  However, the  Agency has  concluded that an
assessment of effects on the male reproductive system  following pre and/or postnatal
exposure is required and these aspects can be addressed by conducting the study as described
in OPPTS 870.3800.
              b.     Acute Toxicity

       Sufficient data are available on the acute toxicity of iprodione. Iprodione is not acutely
toxic via the oral, dermal, inhalation, or ocular routes of exposure. Acute toxicity values and
categories for technical are summarized in Table 3.

Table 3.  Acute Toxicity of Technical Iprodione
Guideline
81-1
81-2
81-3
81-4
81-5
81-6
Study Type
Acute Oral - rat
Acute Dermal - rabbit
Acute Inhalation - rat
Primary Eye Irritation - rabbit
Primary Skin Irritation - rabbit
Dermal Sensitization - guinea
Pig
MRID#
42306301
40567601
42946101
41867301
41867302
40567602
42524601
Results
LD50 = 4468 mg/kg
LD50 > 2000 mg/kg
LC50 = >5.16mg/L
mild irritant
not an irritant
not a dermal sensitizer
Toxicity Category
III
III
IV
III
IV
-
       In an acute oral toxicity study with rats, the LD50 was 4468 mg/kg, which is toxicity
category III [Guideline 81-1; MRID 42306301]. The LD50 in an acute dermal toxicity study
with rabbits was found to be greater than 2000 mg/kg. This is toxicity category III [Guideline
81-2; MRID 40567601]. In an acute inhalation toxicity study with rats, the LC50 was greater
than 5.16 mg/L for 4 hours. This is toxicity category IV [Guideline 81-3; MRID 42946101].

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       In a primary eye irritation study with rabbits, iprodione was a mild ocular irritant. This
istoxicity category III [Guideline 81-4; MRID 41867301]. Iprodione did not induce irritation
in a primary dermal irritation study in rabbits. This is toxicity category IV [Guideline 81-5;
MRID 41867302].

       In a dermal sensitization study in guinea pigs, iprodione was not found to be a dermal
sensitizer [Guideline 81-6; MRID 40567602, 42524601].

             c.     Subchronic Toxicity

       Sufficient data are available on the subchronic toxicity of iprodione. In a 21-day
dermal toxicity  study, five  New  Zealand rabbits/sex/group were administered  iprodione
[96.2%] yja the skin at dose levels of 0,  100, 500, and 1000 mg/kg/day for 21 days. There
were no deaths or clinical signs of toxicity, and no adverse effects were observed on body
weight, food consumption, the skin, liver, or kidneys. The NOEL is > 1000 mg/kg/day, the
highest dose tested  [Guideline ง82-2; MRID 42023201].

       In a subchronic feeding study, 10 Crl:CD(SD)BR rats/sex/group were administered
iprodione [95.7%] via the diet at dose levels of 0, 1000 ppm [dV 787? ? 89 mg/kg/day], 2000
ppm [dV 151/? ? 189 mg/kg/day], 3000 ppm [dV 2527? ? 266 mg/kg/day], and 5000 ppm
[dV 355/? ? 408 mg/kg/day] for 90 days. Signs of toxicity included hunched posture, pilo-
erection,  pale and/or cold extremities, an emaciated appearance, decreased body weight [dV
75%,  52%, and 39% of control/?  ? 86%, 70%, and 55% of control at the 2000, 3000, and
5000  ppm dose levels, respectively], decreased body-weight gain [dV  61% and 26% of
control/? ?  70% and 38% of control at the 2000 and 3000 ppm dose levels, respectively],
negative body-weight gain for both sexes at 5000 ppm, decreased food consumption [81%
of control for 2000 ppm males; 69%/79% of control for males/females at 3000 ppm], and
decreased food efficiency for both sexes at 2000 and 3000 ppm. The 5000 ppm dose group
was terminated early [week 8]. The sex organs, pituitary, and adrenals of both sexes appear
to be target organs for iprodione. In general, the decreases observed in organ weights and the
accompanying increases in relative organ weights may be attributed to the decreased body
weight, but in females, decreased relative organ weights were observed in the uterus, ovary,
adrenal, and pituitary, mainly at the high [3000 ppm] dose. These latter  decreases and the
decrease  in absolute brain weight in females appear to be treatment-related. Dose-related
microscopic lesions were observed in the sex organs and adrenals of both sexes at the 2000,
3000, and 5000 ppm dose levels. The NOEL is 1000 ppm [dV 78/? ? 89 mg/kg/day], and the
LOEL is 2000 ppm [dV 151/? ?  184 mg/kg/day], based on decreased body weight/gain,
decreased food consumption/ food utilization, organ weight effects, and microscopic lesions
in the sex organs.  This  study is classified Acceptable, although clinical chemistry  and
hematology parameters were not monitored. This study was performed to determine
appropriate dose levels for the 2-year chronic toxicity/ carcinogen!city study in rats, and these
parameters were monitored in the long-term study. Therefore, an additional subchronic
feeding study in rats is not required [Guideline ง82-1 (a); MRID 42960701].
                                    10

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       In a subchronic feeding study, 2 Beagle dogs/sex/group were administered iprodione
[technical] via the diet at dose levels of 0, 800 ppm [ซ60 mg/kg/day], 2400 ppm [~  180
mg/kg/day], and 7200 ppm [~ 270 mg/kg/day] for 90 days [standard conversion of 0.075
used].  There were no deaths. One high-dose dog displayed general fatigue with muscular
atony from week 5 to 13. Body weights were comparable among the groups in both sexes.
High-dose dogs  displayed  a slight anemia during the study, as well as increased alkaline
phosphatase and transaminase [SGOT, SGPT] values compared to the controls. There were
no effects reported in clinical chemistry and urinalysis. At necropsy,  both females and one
male at the high dose displayed slight liver hypertrophy and the other male displayed a pale
liver, in addition to anemia and hypertrophy of the prostate and testes. No treatment-related
microscopic lesions were observed.  The NOEL is 2400 ppm [ซ180 mg/kg/day], and the
LOEL  is 7200 ppm [-270 mg/kg/day], based on liver hypertrophy and increased alkaline
phosphatase. This subchronic feeding study in dogs is classified Unacceptable, but there is an
acceptable chronic toxicity  study in dogs; therefore, an additional subchronic study is not
required [Guideline ง82-l(b); MRID 00157377, MRID 00157378, MRID 00232702].

              d.    Chronic Toxicity and Carcinogenicity

       Sufficient data are available to  assess the chronic toxicity and carcinogenic potential
of iprodione. Iprodione has been classified as a Group B2 carcinogen, based on evidence of
tumors in both sexes of mouse [liver] and in the male rat [Ley dig cell]. For the purpose of risk
characterization, a low dose extrapolation model  was  applied to the animal data for
quantification of human risk [Q*j = dV 8.7 x 10 "3/? ? 5.07 x 10"3 combined hepatocellular
adenoma/ carcinoma (mouse) and oV 4.39 x 10"2 testicular tumors (rat)].

                    (1)    Combined  Chronic  Toxicity/Carcinogenicity Study in
                           Rats

       In the combined chronic toxicity/carcinogenicity study in rats,  iprodione [-95% a.i.]
was administered to 60 Sprague-Dawley rats/ sex/dose via the diet at dose levels of 0, 150,
300, and 1600 ppm [dV 6.1, 12.4, and 69/? ? 8.4, 16.5, 95 mg/kg/day, respectively] for 24
months. An additional 10 rats/sex/group were administered iprodione for 52 weeks [interim
sacrifice].

       There were no adverse effects on survival or clinical signs in either sex.  Body-weight
gains were decreased in both sexes at the high-dose level  compared to the  controls  and
overall, body-weight gains were 86% and 92% of control values in the high-dose males and
females, respectively. At week 12, body-weight gain was 83.6% of the control in males and
80.7%  of the control in females at the high-dose level. Food consumption was decreased
slightly at this dose level  in both  sexes also.  There were no treatment-related clinical
pathology findings in either sex. At  the interim sacrifice,  high-dose males  displayed an
increase in the incidence of lesions in the adrenals, and there was an increased incidence of
centrilobular  hepatocyte enlargement  in mid- and  high-dose  males.  High-dose  females
displayed an increase in centrilobular hepatocyte enlargement and an increase in the incidence

                                     11

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of generalized rarefaction and  fine vacuolation of the  zone fasciculata  in the adrenals
compared to the control and other dose groups. At the terminal sacrifice, increased liver
weight [absolute and relative-to-body] was observed in males at the mid- and high-dose levels
[dose-related]. At the high-dose level in males, testes with epididymides and thyroid weights
[absolute and relative-to-body]  were increased at the terminal sacrifice. At the terminal
sacrifice, interstitial cell hyperplasia in the testes, reduced spermatozoa in the epididymides,
and absent/empty secretory colloid cells or reduced secretion in the seminal vesicles were
observed in the mid- and high-dose males. Atrophy of the seminiferous tubules in the testes,
with atrophy of the prostate and absence of spermatozoa in the epididymides were observed
at the high-dose level. Centrilobular hepatocyte enlargement was increased in males at the
high-dose level. Adrenal lesions were observed in both sexes at the mid- and high-dose levels,
although the males displayed more lesions than the females. There was an increased incidence
of tubular hyperplasia in the ovaries and increased sciatic nerve fiber degeneration in the high-
dose females compared to the controls. Hemosiderosis was increased in females at the mid-
and high-dose levels. The  NOEL for non-neoplastic changes is 150 ppm [dV  6.1/? ? 8.4
mg/kg/day], and the LOEL is 300 ppm  [dV 12.47? ? 16.5 mg/kg/day], based on increases in
generalized enlargement of the cells of the zona glomerulosa in males and females, in fine
vacuolation of the zona fasciculata and in generalized fine vacuolation of the zone reticularis
in males in the adrenal cortex, an increased incidence of interstitial cell hyperplasia, reduced
spermatozoa in the epididymides, reduced  secretion  of the  seminal vesicles, increased
hemosiderosis in the spleen in females, and increased liver weight.

       There was an increase in the incidence of both unilateral and bilateral benign interstitial
cell tumors in the testes of males at the 1600 ppm  dose level. There was a dose-related
increasing trend and a significant difference in the pairwise comparison of the 1600 ppm dose
group with controls for testicular tumors, which exceeds the historical  control incidence
[Guideline ง83-5; MRID 42637801; MRID 42787001].

       In an earlier chronic toxi city/carcinogen! city study in Charles River CD outbred albino
rats, no  treatment-related tumors were reported,  although the incidence of testicular
interstitial cell tumors was 2, 2,  4, and 5 out  of 60 rats/group at dose levels of 0, 125 ppm
[-6.25 mg/kg/day],  250  ppm  [-12.5  mg/kg/day], and  1000 ppm [-50 mg/kg/day],
respectively [using standard conversion factor of 0.05]. This study is classified Unacceptable,
but it was replaced by the study cited above [Guideline ง83-5; MRID  00071997; MRID
00128931; MRID 001164249].

                     (2)    Chronic Toxicity Study in Dogs

       In a  chronic feeding study, 6 Beagle dogs/sex/group were administered iprodione
[86.5%] yja the diet at dose levels of 0,  100 ppm [dV 4.1/? ? 4.3 mg/kg/day], 600 ppm [dV
24.97? ? 28.3 mg/kg/day], and 3600 ppm [dV 145.37? ?  152.5 mg/kg/day] for 12 months.
There were  no treatment-related deaths, and no adverse effects were observed on body
weight, food consumption, or clinical signs in either sex. At the high-dose level, there were
increases in absolute and relative liver weight, alkaline phosphatase, SGOT, SGPT and LDH
enzyme levels, and increased absolute and relative adrenal weights [both sexes]. At the mid-
and high-dose levels, males displayed an increased number of erythrocytes with Heinz bodies

                                     12

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and decreased prostate weights. The NOEL is 100 ppm [dV 4.I/? ? 4.3 mg/kg/day], and the
LOEL is 600 ppm [dV 24.97? ? 28.3 mg/kg/day], based on decreased prostate weight and
an increased incidence of erythrocytes with Heinz bodies  [Guideline ง83-l(b); MRID
00144391; MRID 41327001].

       In a second chronic feeding study designed to complement the study cited above, 6
Beagle dogs/sex/group were administered iprodione [96.1%] via the diet at dose levels of 0,
200ppm [dV7.8/? ? 9.1 mg/kg/day], 300ppm [dV 12.47? ? 13.1 mg/kg/day], 400ppm [dV
17.57? ?  18.4], and 600 ppm [dV 24.67? ? 26.4 mg/kg/day] for 12 months. There were no
treatment-related deaths,  and no adverse  effects were observed on clinical  signs,  body
weight/gain, and food consumption in either sex. At the high-dose level, decreases were
observed in the red blood cell parameters [hemoglobin, hematocrit, and red blood cells]. The
NOEL for systemic toxicity is 400 ppm [dV 17.57? ? 18.4 mg/kg/day], and the LOEL is 600
ppm [dV 24.67? ?  26.4  mg/kg/day],  based on decreased red blood  cell values. This
nonguideline study is classified Acceptable. When both chronic dog studies are considered
together, the NOEL is 400 ppm [=18 mg/kg/day] [Guideline ง83-l(b); MRID 42211101].

                    (3)    Carcinogenicity Study  in Mice

       In a carcinogenicity study, iprodione [95.7% a.i.] was administered in the diet to 50
Crl: CD-I (ICR) BR mice/sex/dose for 99 weeks at dose levels of 0,  160 ppm [dV 237? ? 27
mg/kg/day], 800 ppm  [dV  1157?? 138  mg/kg/day], and 4000 ppm  [dV 604/? ? 793
mg/kg/day]. There was an interim sacrifice group of 15 mice/sex/group.

       The statistical evaluation of mortality indicated no significant incremental changes
with increasing dose in either sex, although the high-dose  group displayed the highest
mortality rate for both sexes. Food consumption and clinical signs were comparable among
the groups for both sexes. Decreased body- weight gains [overall gain dV 86%7? ? 89% of
control] were observed in both sexes at the highest dose level. There was an increase in the
incidence of liver tumors  in both sexes at the high-dose level, which was accompanied by
increases in several liver lesions [centrilobular hepatocyte enlargement/ vacuolation, area(s)
of enlarged eosinophilic hepatocytes, pigmented macrophages, centrilobular necrosis, and
amyloid deposits]. SGOT and SGPT levels were elevated at the high-dose level in both sexes
compared to the  controls  at the interim sacrifice [only  time examined for these enzymes].
Liver weight was increased at the high-dose level in  both sexes at both the  interim and
terminal sacrifices. There was an increase in the incidence of benign ovarian tumors [luteoma]
in females at the high dose compared to the control incidence, which was accompanied by an
increase in luteinization of the interstitial cells, corpora lutea absent, and prominent granulosa
cells. There was also an increased incidence of generalized vacuolation/hypertrophy of the
interstitial cells of the testes in the mid- and high-dose males compared to the controls.
Dosing was considered adequate, based on an overall decrease in body-weight gain [dV
86%7? ?  89% of control].  The LOEL is 800 ppm [dV 1157? ? 138 mg/kg/day], based on the
increased incidence of centrilobular hepatocyte enlargement in females and the increased
incidence of generalized vacuolation/hypertrophy of the interstitial cells in the testes of males.
The NOEL is 160 ppm [dV 237? ? 27 mg/kg/day] [Guideline ง83-2; MRID 42825002].
       In a previous chronic toxicity/carcinogenicity study in Carworth CF-1 albino  mice,
iprodione was negative for carcinogenicity.  The dose levels were 200 ppm [=30 mg/kg/day],

                                    13

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500 ppm [ซ75 mg/kg/day], and 1250 ppm [ซ187.5 mg/kg/day] (using standard conversion
factor of 0.15), and the duration was 18 months. Only one ovarian tumor [malignant] was
reported [mid dose], and the incidence of liver tumors was as follows:

Table 4. Liver Tumors (# with Tumor, # mice examined)
Sex


Males


Females

Dose/Tumor Type
0
200
500
1250
0
200
500
1250
Benign
0/60
2/59
0/60
2/59
0/60
0/60
1/58
0/59
Malignant
2/60
0/59
4/60
5/59
0/60
0/60
2/58
1/59
       This study is classified unacceptable, but in has been replaced by the study cited above
[Guideline ง83-2; MRID 00070963].

                     (4)    Studies on Carcinogenicity Mechanism of Action

       Several mechanistic studies on iprodione are available. These were  submitted in
support of the premise that both the liver and testicular tumors are threshold phenomena.

                           TESTES

       In an in vitro study using immature porcine cultured Leydig cells, iprodione [99.7%]
and two of its metabolites [RP36112 (99.2%) and RP36115 (96.7%)] inhibited testosterone
secretion when Leydig cells were stimulated with (1) the gonadotropin hCG, (2) with drugs
that enhance cAMP production [(a) cholera toxin, which stimulates Gs protein;  (b) forskolin,
which stimulates adenylate cyclase catalytic unit, and (3) with a cAMP analog [8-bromo-
cAMP].  Because  there were  no effects  observed on  gonadotropin-stimulated cAMP
production with iprodione, it is hypothesized that the inhibition of testosterone secretion by
iprodione is   downstream from  cAMP  production. At the next step in  testosterone
biosynthesis, inhibition of testosterone secretion by iprodione was not observed when the
substrate 22ROHCT was added to the culture medium, which indicates that the step that is
inhibited is  located between the cAMP production and the  movement/penetration of
cholesterol into the mitochondria. Since 22ROHCT is a  cholesterol substrate that passes
through the mitochondrial membrane without the need of an active transport system, the
sensitive site of inhibition of testosterone synthesis by iprodione [or RP 36115] maybe the
transport/availability of cholesterol substrate for the cholesterol side chain cleavage enzyme.
The RP 36112 metabolite appears to act downstream from the cholesterol step; i.e., at the
level of steroidogenic enzyme 17  ahydroxylase/17, 20 lyase.  Iprodione and its metabolites
appear to modulate Leydig cell steroidogenesis by interfering at the level of cholesterol
transport and/or steroidogenic enzyme activity. [Non-Guideline; MRID 44171901].
       In another  in vitro  study, the objective was to  determine the effect of in vitro
iprodione [99.7%]  exposure on basal testosterone secretion and stimulated  release from
                                     14

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testicular sections in culture media [in vitro Endocrine Challenge Test (ECT) using human
chorionic gonadotropin (hCG)]. The effects of prior in vivo exposure of the male rats via the
diet [3000 ppm iprodione for 14 days] was also evaluated. Testicular sections obtained from
12 male CDฎ Sprague-Dawley rats administered iprodione via the diet for 14 days at dose
levels of 0 ppm or 3000 ppm were incubated with 0, 1, 10, or 100 |ig/mL iprodione for one
hour. Half of these testicular sections from each in vitro treatment group were challenged
with human chorionic gonadotrophin and the other half of the sections were monitored for
basal testosterone secretion. Media testosterone concentrations were monitored at hourly
intervals for 3 hours after challenge. There was a dose-related reduction  in testosterone
secretion from testicular sections incubated in vitro with iprodione, with and without hCG
stimulation. Prior exposure of the rats to iprodione in vivo for 14 days appeared to have little
effect on the secretion of testosterone, with and without hCG stimulation,  from testicular
sections incubated in vitro other than a slight increase initially. At sacrifice following the 14-
day exposure period to iprodione in vivo, plasma LH concentrations were significantly
increased compared to the control and,  although plasma testosterone was not significantly
affected, the levels were somewhat increased compared to the control [132% of control]. The
significant increase in plasma LH at  necropsy suggests  a possible stimulation of the
homeostatic mechanism. Under the conditions of this 14-day study, iprodione was shown to
produce a reduction in testosterone secretion from testicular sections following incubation
in vitro with iprodione. Prior exposure of male rats to iprodione in vivo via the diet for 14
days did not alter the reduction in testosterone secretion observed in their testicular sections
exposed to iprodione in vitro. Although the in vitro inhibition appeared to be dose-related,
it appears that a maximum response may have occurred between the 10 and 100 |ig/mL dose
levels. The data presented provide pieces to the  "puzzle" but not a complete  picture of what
may be occurring in the testes/rat that ultimately results in testicular tumors. Although it
appears that the premise is that iprodione produces testosterone biosynthesis inhibition,
resulting ultimately in the increased incidence of Ley dig cell tumors, there are inconsistencies
in the in vitro and in vivo data, and the in vitro effects observed in the short-term studies to
date have not been demonstrated to occur in long-term studies, nor is it clear that the levels
at which the in vitro  effects were observed are attained in vivo. [Non-Guideline; MRTD
44171903].

       In an in vivo study, no changes in testicular function, as assessed by measuring
testosterone levels in plasma and testicular homogenates from 15 male Sprague-Dawley rats
administered iprodione [97.3%] via the diet at doses levels of 0 ppm and 3000 ppm for 2, 7
or 14 days, were observed. Decreased body weight [95% of control after 2 days, 90-91% of
control after 7 days, and 87% of control after 14 days], body-weight gain [negative gain after
2 days, 32% of control after 7 days, 44% of control after 14  days], and food consumption
were observed following all exposure intervals. Organ-weight  effects included decreased
absolute liver, kidney, epididymis, and total accessory sex organs [TASO]; increased absolute
and relative adrenal; and decreased relative TASO. The objective of this study was to assess
the effects of in vivo iprodione exposure on plasma and  testicular homogenate testosterone
concentrations in the male rat following a human chorionic gonadotrophin [hCG] Endocrine
Challenge Test (ECT). There were no significant differences in either peripheral plasma or

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testicular homogenate testosterone levels observed in samples collected one hour after human
chorionic gonadotrophin [hCG] challenge. Under the conditions of this study, iprodione did
not produce alterations in testicular function following dietary exposure at 3000 ppm for up
to 14 days [Non-Guideline; MRID 44171904].

       In a mechanistic study in male rats designed to (a) assess the competitive binding
affinity of iprodione to the androgen receptor;  (b) establish an effective dose and dosing
regimen and quantify testosterone, luteinizing hormone [LH], follicle-stimulating hormone
[FSH], and estradiol concentrations in a single plasma sample; and (c) describe testosterone,
LH, and FSH profiles during a 4-hour baseline occurring after 30 days of iprodione exposure,
iprodione was shown to have poor binding affinity  to the androgen receptor  following
exposure at very high dose levels. LH and FSH concentrations were increased after 15 days
exposure but  not  after 30 days of exposure to  iprodione. At necropsy, testosterone
concentrations were comparable between the iprodione and the pair-fed  rats, and estradiol
concentrations were increased at necropsy following 30 days of exposure. A marked increase
in adrenal weights, accompanied by histopathological lesions [vacuolation] indicative of an
alteration of steroidogenesis, was observed following the 30-day exposure period. Although
there was some evidence  to suggest that iprodione interferes with sex/steroid  hormone
regulation,  the differences in the spectrum of effects  observed between  iprodione and
flutamide in this study  indicate  that the two  compounds share only  certain parts of a
mechanism of toxicity/carcinogenicity. [Non-Guideline; MRID 43535002; MRID 44203401].

       In an in vitro study using porcine cultured Leydig cells, iprodione [99.7%] and two
of its metabolites were shown to inhibit gonadotropin-stimulated testosterone secretion in a
concentration range of 1-10 |ig/mL. Inhibition by iprodione was observed after short-term
exposure [3 hours],  and the inhibitory  effects were similar to those observed with  the
fungicide ketoconazole.  The inhibitory effects  do  not appear to be  related  to Leydig cell
damage because the removal of iprodione from the culture  medium for 72 hours resulted in
the recovery of the cells ability to secrete testosterone following hCG stimulation. There was
no discussion as to how the concentrations of iprodione used in this study  relate to the levels
attained within the testicular cells following oral dosing in the rat carcinogenic study where
testicular tumors were observed. [Non-Guideline; MRID 43830601].

                           LIVER

       In  a  3-day  and  14-day  oral  exposure  study,  groups  of   CD1  male  mice
[15/dose/group/chemical; 7 weeks old on arrival] were administered (1) iprodione vja the diet
at dose levels of 4000 ppm  [696 mg/kg/day]  or 12000 ppm [2138 mg/kg/day];  (2)
ketoconazole via the diet at a dose of 2000 ppm [341 mg/kg/day]; (3)  phenobarbital via
gavage at a dose level of 75 mg/kg/day; and (4) cyproterone acetate via gavage at a dose level
of 40 mg/kg/day. The control for the dietary studies was basal diet, and 0.5% methylcellulose
was the control of the gavage studies. The objective of the study was to examine the potential
liver effects of iprodione in mice and to compare these effects with those produced by well
characterized liver enzyme  inducers and/or rodent liver  carcinogens. Ketoconazole was

                                     16

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selected as a positive control for its potential to inhibit testosterone secretion; phenobarbital
and cyproterone acetate were selected for their potential to induce early liver changes and
subsequent liver tumor formation in  rodents. All  of  the  liver  effects produced  by
ketoconazole, phenobarbital, and/or cyproterone acetate [increases in liver weight, alanine
aminotransferase, aspartate aminotransferase, # hepatocytic mitoses, total cytochrome P-450
content,  staining  for  isoforms CYP  2B  and CYP 3A, benzoxyresorufm  [BROD],
ethoxyresorufm  [EROD], pentoxyresorufin  [PROD]  enzyme activities,  and hepatocyte
proliferation,  in  addition to  increases  in the incidence of liver enlargement, centrilobular
hypertrophy, diffuse hypertrophy, centrilobular/midzonal fine vacuolation] were exhibited by
iprodione at 12000 ppm. An effect observed following iprodione exposure that was not
observed following any of the other test material exposures was an increase in lauric acid
hydroxylation. Although several of the  effects  observed  in the liver following iprodione
exposure  are analogous to those observed  following the positive controls, especially
phenobarbital [centrilobular hypertrophy, liver weight, increased BROD, PROD, and EROD
activities, cell proliferation after 3 days],  in several cases the liver effect observed was most
pronounced in the iprodione mice compared to the positive controls [centrilobular/midzonal
fine vacuolation, increased number of mitoses, cell proliferation at day 15].

       This study demonstrates that iprodione, at dose levels that are 5- and  15- fold greater
than the LOEL for liver effects observed in the mouse carcinogen!city study, induces (1) liver
cell proliferation, (2) increased  microsomal enzyme activities,  (3) an increase  in total
cytochrome P-450 content,  and (4) centrilobular hypertrophy. These observations most
closely resemble the pattern of liver effects observed following phenobarbital exposure.
Hepatocytic hypertrophy was observed at the high-dose level of iprodione following both the
3- and 14-day exposure periods but only following the 14-day exposure period at the low
dose. Liver cell proliferation was observed after both the 3-day and 14-day exposure periods
at both dose levels  of iprodione.  Increased cytochrome P-450 content and increased
microsomal enzyme activities were observed  at both dose levels of iprodione following the
14-day exposure period, but neither analysis was performed following the 3-day exposure
period. The dose level where liver tumors were observed in the mouse carcinogenicity study
[604 mg/kg/day] is comparable to the low dose used in the current study. The findings in this
study  support the Registrant's arguments that the liver tumors observed in the iprodione
mouse carcinogenicity study may be secondary to liver toxicity. However, several pieces of
data are lacking. The current study does not address whether cytochrome P-450 content and
the microsomal enzyme activities are increased initially [after the 3-day exposure period];
therefore, one cannot determine whether the  cell proliferation and hepatocytic hypertrophy
observed after 3-days exposure to iprodione is due to a direct effect of iprodione on the liver
or the result of adaptive processes. Additionally, the current study does not identify a NOEL
for the liver effects monitored over a 14-day exposure period or address the question of
whether  these liver effects occur initially  at the lower  doses utilized  in the mouse
carcinogenicity study. Another outstanding question is whether the liver effects [hepatocytic
hypertrophy, increased total cytochrome P-450 content, increased microsomal activities, cell
proliferation] observed in the current study persist throughout a long-term exposure. It is to
be noted  that phenobarbital produces a short-term increase in hepatocyte proliferation that

                                     17

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is not sustained. In a paper on proliferation and liver tumor development [CUT Activities,
vol.  15  (8),  August, 1995], it is stated that the proliferative response seen after acute
exposure does not always reflect the proliferative response observed after chronic exposure
[Non-Guideline; MRID # 44171902]].

       Based on these mechanistic  studies, the Agency's  Cancer Assessment Review
Committee (CARC) concluded that the data available do not provide a definitive mode of
action with respect to either the Ley dig cell tumors or the liver tumors.

             e.     Reproduction and Developmental Toxicity Studies

                    (1)     Two-Generation Reproduction Study in Rats

       In a  2-generation reproduction study, 28 Crl:CDฎBR/VAF/PLUS rats/sex/group
were administered iprodione [96.2%] via the diet at dose levels of 0, 300 ppm [dV 18.57? ?
22.5 mg/kg/day], 1000 ppm [dV 61.47? ? 76.2 mg/kg/day], and 3000/2000 ppm [dV
154.87? ? 201.2 mg/kg/day] for two  generations [2 litters per generation]. The systemic
maternal/parental NOEL was 300 ppm [dV 18.5/? ?  22.5 mg/kg/day], and the LOEL was
1000 ppm [dV61.4/? ? 76.2 mg/kg/day], based on decreased body weight, body -weight gain,
and food consumption in both sexes and both generations.  The  reproductive [offspring]
NOEL was 1000 ppm [76.2 mg/kg/day], and the reproductive [offspring] LOEL was 2000
ppm [201.2 mg/kg/day], based on decreased pup viability [as evidenced by an increased
number of stillborn pups and decreased survival during postnatal days 0-4], decreased pup
body weight throughout lactation, and an increased incidence in clinical signs in pups during
the lactation period [smallness, reduced mobility, unkempt appearance, hunching, and/or
tremors] [Guideline ง83-4; MRID 00162983; MRID 41871601].

                    (2)     Developmental Toxicity Study in Rats

       In a developmental toxicity study, 20 pregnant Sprague-Dawley CD rats [mated 1:1]
were administered iprodione [94.2%] at dose levels of 0 [0.5% methylcellulose], 40, 90, and
200 mg/kg/day via gavage from day 6 through 15 of gestation. On day 20 of gestation, the
dams were sacrificed  via CO2 inhalation. There were no  deaths.  Body weights  were
comparable among the groups. There  were no significant differences observed in the mean
number of  viable  fetuses,  implantations,  corpora lutea,  resorptions,  and  pre- and
postimplantation losses were comparable among the groups. There was no evidence of
maternal toxicity at any dose level [maternal NOEL > 200 mg/kg/day. The developmental
NOEL was 90 mg/kg/day, and the developmental toxicity LOEL was 200 mg/kg/day, based
on delayed fetal development [slightly reduced fetal body weight and increased incidences of
space between the body wall and organs in the fetuses].  [Guideline ง83-3(a); MRID
00162984; MRID 40514901].

       In a 1976 prenatal developmental toxicity study, groups of pregnant Sprague-Dawley
rats (25-30/dose) received iprodione (100%) in 1% carboxymethylcellulose via gavage at

                                    18

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doses of 0, 100, 200, or 400 mg/kg/day during gestation days 5 through 15. For maternal
toxicity, the NOEL was 200 mg/kg/day and the LOEL was 400 mg/kg/day based on slightly
decreased  body weight  gain and  significantly  decreased  food  consumption.    For
developmental toxicity, the NOEL was 200 mg/kg/day and the LOEL was 400 mg/kg/day
based on decreased implantation sites.  This study does  not appear to provide  a robust
evaluation of fetal effects following in utero exposure of iprodione (MRID 0071324).

       In a 1997 special prenatal  developmental toxicity study, pregnant Sprague-Dawley
rats (25/dose) received iprodione (97.1%) in methylcellulose via gavage at dose levels of 0,
20, 120, or 250 mg/kg/day during gestation days 6 through 19.  For maternal toxicity, the
NOEL was 20 mg/kg/day, the LOEL was 120 mg/kg/day, based on decreased body-weight
gain and decreased food efficiency.  At 250 mg/kg/day, deaths occurred [9 out of 25] in
addition to decreased body-weight gain and food consumption/ efficiency. For developmental
toxicity, the NOEL was 20 mg/kg/day and the LOEL was 120 mg/kg/day, based on decreased
anogenital distance (AGD) in the male pups (MRID No. 44365001).

                    (3)    Developmental Toxicity Study in Rabbits

       In a developmental toxicity study, 18 artificially inseminated New Zealand female
rabbits were  administered iprodione [95.0-99.3%]  at dose levels of 0 [0.5%  aqueous
methylcellulose], 20, 60, and 200 mg/kg/day via gavage from day 6 through 18 of gestation.
On day 29 of gestation, the does were sacrificed. Seven high-dose does aborted between days
17 and 23  of gestation, and prior to aborting all had displayed decreased urination and
defecation. One mid-dose doe [day 28] and one control doe [day 20] also aborted. All other
does survived until study termination, and nine of the high-dose does that did not abort
displayed decreased urination and defecation. During the dosing period, the mid-dose does
gained less weight than the control, and the high-dose does lost weight. A negative net body-
weight gain was observed at the mid- and high-dose levels. The high-dose does displayed
decreased food consumption during the dosing period. Gravid uterine weight was decreased
at the high-dose level [90% of control] compared to the control.  The maternal NOEL is 20
mg/kg/day, and the maternal LOEL is 60 mg/kg/day, based on decreased body-weight gain.
At the highest dose tested [200 mg/kg/day], maternal toxicity was demonstrated by an
increased rate of abortions [7 does],  body-weight loss, decreased food consumption, and
decreased defecation and urination in females that aborted. The developmental toxicity NOEL
was 60 mg/kg/day, and the developmental toxicity LOEL was 200 mg/kg/day, based on an
increased incidence  of skeletal variations [13th full rib, malaligned sternebrae, and/or 27
presacral vertebrae, with or without delayed ossification]. [Guideline ง83-3(b); MRID
00155469].

       Due to the structural similarity of iprodione to procymidone and vinclozolin and to
the observed effects on the reproductive  system in males in the long-term  feeding study in
rats, a pre-and postnatal developmental  toxicity study is required to assess the effects of
iprodione on the male reproductive system for iprodione. This concern for postnatal exposure
was highlighted previously by the RfD Committee (2/10/94). These effects can be addressed

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by adhering to the new guidelines for reproductive toxicity, OPPTS 870.3800. This study is
required.

                    (4)    Mutagenicity Studies

       Sufficient data are available to satisfy data requirements for mutagenicity testing [ง84-
2].

              f.     Gene Mutation

       Iprodione was negative for induction of reverse gene mutations at the histidine locus
in Salmonella typhimurium strains TA 98, TA 100, TA1535, TA 1537, and TA 1538, both
in the presence and absence of S9 activation. There was sufficient cytotoxicity, as evidenced
by reductions in mean numbers of revertants and background lawn, at the highest dose in the
absence of S9, and a slight to moderate precipitate was observed at doses > 250 jig/plate in
the presence and absence of S9. In the presence of S9, iprodione was assayed to the limit dose
[Guideline ง84-2; MRID 41604106].

       Iprodione did not induce mutation with or without metabolic activation in the in vitro
forward gene mutation [CHO/HGPRT] assay  at adequate dose levels [Guideline ง84-2;
MRID 00148206].

              g.     Chromosomal Aberration Assay

       Iprodione  was negative  in an in vitro  chromosomal aberration assay in Chinese
hamster ovary [CHO] cells both in the presence and absence of metabolic activation at
adequately high dose levels [doses of 40, 150, 400 |ig/mL with;  doses  of 15, 75, 150 |ig/mL
without S9]. There was precipitation at exposure levels > 150 |ig/mL both with and without
S9. [Guideline ง84-2; MRID 00148207].

       In an in vivo mouse micronucleus assay, 5 CD-I  mice/sex/group were administered
iprodione [96.1%] suspensions [1% aqueous methylcellulose] via oral gavage once at dose
levels of 750, 1500, and 3000 mg/kg. Bone marrow cells were collected for micronucleated
polychromatic erythrocytes [MPEs]. One male and  eight females died at the high dose, and
signs of toxicity at this dose level included piloerection, hunched  posture, ptosis, lethargy, and
coma. Dose-related cytotoxic effects on the target tissue were also seen at 48 hours postdose;
the response was significant at the high dose. The positive control induced the expected high
yield of MPEs in both sexes.  There was no evidence of a clastogenic or aneugenic effect at
any dose or harvest time [Guideline ง84-2; MRID 43535001].

              h.     Other Genotoxic Effects

       Iprodione was negative in a sister chromatid exchange assay in Chinese hamster ovary
cells both with and without metabolic activation [Guideline ง84-2; MRID 00148209].

                                     20

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       Iprodione was tested against 19 strains [including 2 wild type] of Bacillus subtilis both
with and without metabolic activation at dose levels of 20.6-1670 jig/disc. Iprodione was
positive both with and without metabolic activation [Guideline ง84-2; MRID 00148208].

              i.      Metabolism

       Sufficient data are available on the metabolism of Iprodione in the rat. 14C-Iprodione
was absorbed readily from the gastrointestinal tract, metabolized, and excreted by rats of both
sexes following single low [50 mg/kg] and high [900 mg/kg] oral doses and 14 repeated low
[50 mg/kg/day] doses.  Peak blood levels were observed at 4 and 2 hours, respectively, in the
low-dose males and females and at 6 hours in the  high-dose rats of both  sexes. The
elimination of 14C from the blood was slower in males than in females. There were both dose-
and sex-related differences noted in absorption; males absorbed a greater percentage of the
low and repeated doses than females. Although levels of 14C were found in most tissues
monitored, the levels were < 0.5% of the total amount administered. It is to be noted that the
testes of the low-dose  males [both single and repeat] showed no detectable amount of 14C;
the high dose in the rat chronic toxicity/ carcinogenicity study where testicular tumors were
observed was 69 mg/kg/day. The primary route of elimination of 14C following single and
repeat low dose exposure was the urine, and the feces was the primary route following high-
dose exposure. Dealkylation and cleavage of the hydantoin ring were the two primary steps
in the metabolism of Iprodione. Hydroxylation of the phenyl ring and oxidation of the alkyl
chain also occurred. The primary metabolites recovered from the urine [both sexes] included
a dealyklated  derivative of Iprodione and 2 polar but unidentified compounds. Males
produced larger amounts of a hydantoin ring-opened metabolite than females, and the urine
of the females contained a higher proportion of unchanged parent than that of the males.
Several urinary metabolites were not identified. The feces contained much larger amounts of
unchanged parent than the urine, which the authors suggested was unabsorbed iprodione and
metabolites or hydrolyzed conjugates of absorbed material.

       In another single oral administration study in rats using 50 mg/kg, no sex differences
were apparent in the excretion profile, and both urinary elimination [dV 37%/? ? 28%] and
fecal excretion [dV 56%/? ? 50%] were major routes of excretion, and the majority of the
radiolabel was excreted within the first 24 hours post dose in both sexes. Approximately 80%
of the 24-hour urine sample radiolabel [-24% of the dose] and ~9\% of the 24-hour fecal
radiolabel [ซ49% of the dose] were characterized. Overall, -72% of the dose was identified,
which accounted for nearly 90% of the total radiolabel found in the samples. The metabolism
of iprodione was extensive and characterized by the large number of metabolites formed. In
the urine, RP 36115, RP 32490, RP 36112, RP 36119, and RP 30228 were either confirmed
or indicated. The feces contained a large proportion of parent; the major  fecal metabolites
were RP 36115, RP 36114,  RP 32490, and RP 30228.

       A general metabolic pathway for iprodione in the rat indicates that biotransformation
results in hydroxylation of the aromatic ring, degradation of the isopropylcarbamoyl chain,
and rearrangement followed by cleavage of the hydantoin  moiety. Additionally,  structural

                                    21

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isomers of iprodione resulting from molecular rearrangement, as well as intermediates in the
pathway, were  detected [Guideline ง85-1;  MRID 41346701; MRID 42984101;  MRID
43484901].

             j.     Dermal Penetration Study

       In a  dermal penetration study, 4 male Crl: CDฎBR rats/group/time point were
exposed dermally to a single dose of iprodione at dose levels of 0.4, 4.0, and 40 mg/rat for
0.5, 1, 2, 4, 10, and 24 hours. Skin residues increased with the duration of exposure to 5-10%
of the applied dose, although there was no apparent dose response. The portion of the test
material absorbed increased with the duration of exposure to 7.41%, 3.16%, and 0.19% of
the applied dose at 0.4, 4.0, and 40 mg/rat, respectively. Absorption appears to be saturated
at the two highest dose levels.  Following a 10-hour  exposure period,  ซ5% iprodione is
absorbed [Guideline ง85-2; MRID 43535003].

             k.     Inhalation Toxicity

       The only inhalation study available for iprodione is an acute inhalation toxicity study,
with an acute LD50 = 5.16 mg/L [MRID 42946101]. These results place iprodione in Toxicity
Category IV. No other studies are available via this route.

       2.     Dose - Response Assessment

       The dose-response assessment for iprodione was conducted by OPP' s toxicology peer
review committees, who selected risk  assessment  endpoints after  reviewing the  entire
toxicology database for iprodione.  A brief  history of the findings  of OPP's peer  review
committees is presented below.

       On February 10, 1994 EPA's RfD/Peer Review Committee established a Reference
Dose (RfD) of 0.06 mg/kg/day based on a NOEL of 6.1 mg/kg/day established in a combined
chronic toxi city /carcinogen! city  study in rats and an Uncertainty Factor of  100 for inter-
species extrapolation and intra-species variability.

       On  October  16,  1997,  the EPA's Hazard Identification  Assessment Review
Committee (HIARC) evaluated the  toxicology  data  to  assess the potential enhanced
sensitivity of infants and children from exposure to iprodione as required by the Food Quality
Protection Act (FQPA) of 1996.  On February 25, 1998, the HIARC met again to re-evaluate
the  toxicological  endpoints for acute and chronic  dietary as well as  occupational and
residential (dermal and inhalation) exposure risk assessments in light of a recently submitted
special prenatal developmental  toxicity sexual differentiation study  in rats (MRID No.
44365001).  The HIARC determined that the application of the FQPA safety factor for the
protection of infants and children from exposure to iprodione, as required by FQPA, would
be determined during risk characterization.
                                    22

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             a.     Determination of Susceptibility to Infants and Children

                    (1)    Neurotoxicity Data

       Neurotoxicity studies are not required since iprodione is neither an organophosphate
nor structurally related to compounds that are known to induce neurotoxicity.

                    (2)    Developmental Toxicity Data

       In a 1986 prenatal developmental toxicity study, groups of pregnant Sprague-Dawley
rats (25-30/dose) received iprodione (100%) in 1% carboxymethylcellulose via gavage at
doses of 0, 100, 200, or 400 mg/kg/day during gestation days 5 through 15.  For maternal
toxicity, the NOEL was 200 mg/kg/day and the LOEL was 400 mg/kg/day based on slightly
decreased   body weight  gain and  significantly  decreased food  consumption.   For
developmental toxicity, the NOEL was 200 mg/kg/day and the LOEL was 400 mg/kg/day
based on decreased  implantation sites.  This study does not appear to provide a robust
evaluation of fetal effects following in utero exposure of iprodione (MRID 0071324).

       In a 1986 prenatal developmental toxicity study, groups of pregnant Sprague-Dawley
rats were given oral (gavage) administrations of iprodione (94.2%) in 0.5% methylcellulose
at doses of 0, 40, 90, or 200 mg/kg/day during gestation days 6 through 15.  No maternal
toxicity was observed (maternal NOEL >200 mg/kg/day).  For developmental toxicity, the
NOEL was 90 mg/kg/day and the LOEL  was 200 mg/kg/day, based upon  delayed fetal
development, as evidenced by slightly reduced fetal weights and an increased incidence  of
space between the body wall and organs in fetuses(MRID 00162984).

       In a 1997 special  prenatal developmental toxicity study, pregnant Sprague-Dawley
rats (25/dose) received iprodione (97.1%) in methylcellulose via gavage at dose levels of 0,
20,  120, or 250 mg/kg/day during gestation days 6 through 19. For maternal toxicity, the
NOEL was 20 mg/kg/day, the LOEL was 120 mg/kg/day, based on decreased body-weight
gain and decreased food efficiency. At 250 mg/kg/day, deaths occurred [9  out of 25]  in
addition to decreased body-weight gain and food consumption/ efficiency. For developmental
toxicity, the NOEL was 20 mg/kg/day and the LOEL was 120 mg/kg/day, based on decreased
anogenital distance in the male pups (MRID No. 44365001).

       In  a prenatal  developmental toxicity study, pregnant New Zealand  white rabbits
(18/group), were given oral (gavage) administration of iprodione (95% or 99.3%, from two
different lots) in 0.5% Methocel at doses of 0,20, 60, or 200 mg/kg/day during gestation days
6 through  18. For maternal toxicity, the NOEL was 20 mg/kg/day and the LOEL was 60
mg/kg/day based on decreased body weight gain. Also at 200 mg/kg/day, the following were
observed: increased numbers of abortions, body weight loss, decreased food consumption and
decreased defecation and urination. For developmental toxicity, the NOEL was  60 mg/kg/day
and the LOEL was 200 mg/kg/day based upon increased skeletal variations (13th full rib,
malaligned sternebrae, and 27  presacral vertebrae, occurring alone or in combination with
each other or accompanied by  delayed ossification) (MRID No. 00155469).

                                   23

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                     (3)    Reproductive Toxicity Data

       In a two-generation reproduction study, male and female Sprague-Dawley received
diets containing iprodione (96.2%) at 0, 300, 1000, or 2000/3000 ppm (0, 18.5, 61.4, or
154.8 mg/kg/day for males and 22.49, 76.2, or 201.2 mg/kg/day for females) For parental
systemic toxicity, the NOEL was 300 ppm (21 mg/kg/day) and the LOEL was 1000 ppm (69
mg/kg/day), based on  decreased body weight, body weight gain, and food consumption in
both sexes and generations. For offspring toxicity, the NOEL was 1000 ppm (69 mg/kg/day)
and the LOEL was 2000/3000 ppm (178 mg/kg/day), based on decreased pup viability (as
evidenced by an increased number of stillborn pups and decreased survival during postnatal
days 0-4), decreased pup body weight throughout lactation, and an increased incidence in
clinical signs (smallness, reduced mobility, unkempt appearance, hunching, and/or tremors)
in pups during the lactation period. (MRID No. 41871601).

                     (4)    Determination of Susceptibility

       The prenatal developmental toxicity study in rabbits, the special prenatal study in rats,
and the two-generation reproduction study in rats demonstrated no indication of increased
susceptibility to in litero and/or postnatal exposure to iprodione.

       In the 1986 prenatal developmental toxicity study in rats, however, developmental
effects in the fetuses (a slight dose-related decrease in fetal weight and increased incidence
of fetuses with a space between the body wall and the internal organs) were noted in the
absence of maternal toxicity. It is noted that the fetal findings were suggestive but not
conclusive of fetal toxicity. Fetal weights were not altered in a statistically significant manner
and were well within historical values.  The incidence of space between the body wall and
organs was also not apparently statistically significant. This finding may have been supportive
(as were the c-section  observations of "small fetus") of weight decrements in fetuses at the
LOEL, but it could also be an artifact of preservative techniques. Also, the fetal findings were
marginal and not statistically significant, within ranges of historical control values, and were
not supported by data  from other studies.  Therefore, due to the lack of confidence in these
data, the findings of this study were not judged to be an appropriate measure of potential
sensitivity following in utero exposure to iprodione. Based on the weight-of-the-evidence of
all available studies, the Committee concluded that there was no increased susceptibility to
rat and rabbit fetuses following in utero and/or post natal exposure to iprodione.

                     (5)    Recommendation for a Developmental Neurotoxicity Study

       Based on  the  following weight-of-the-evidence  considerations,  the  Hazard
Identification  Assessment Committee (HIARC)  determined  that a  developmental
neurotoxicity study in rats is not required for iprodione.

       (i) Evidence that support not requiring a developmental neurotoxicity study:
                                     24

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#      Overall, iprodione does not appear to be a frankly neurotoxic chemical. There
       were no effects on brain weight or histopathology (nonperfused) of the
       nervous system in the chronic studies in rats, mice, and dogs.  Findings that
       were  suggestive of  neurotoxicity (see below) were often  equivocal,
       unsupported by data from other studies, and/or observed only at doses which
       compromised the survival of the animals.

#      No evidence  of developmental anomalies of the fetal nervous system was
       observed in the prenatal developmental toxicity  studies in  either rats or
       rabbits,  at developmentally and/or maternally toxic oral doses  up to 200
       mg/kg/day.

#      Evaluation of the special postnatal developmental toxicity study did not reveal
       any endpoints of concern that would trigger a developmental neurotoxicity
       study.

(ii) Evidence that would suggest the need for a developmental neurotoxicity study:

#      In the chronic toxicity study in rats, degeneration of the sciatic  nerve was
       observed after 2 years of dietary exposure to iprodione. This finding was also
       observed at a relatively  high incidence in control  animals, although the
       incidence doubled for females at the highest dose tested (1600 ppm).

#      In the  carcinogenicity study  in mice, absolute  brain weight was slightly
       decreased and adjusted brain weight was significantly decreased at the HDT
       (4000 ppm).

#      In the 90-day subchronic study in rats, absolute brain weight was significantly
       decreased for females only at the HDT (3000 ppm). Clinical signs of toxicity
       in this study included piloerection and hunched posture at 3000 and 5000 ppm
       (the 5000 ppm treatment group was terminated early due to severe toxicity).

#      In the two-generation reproduction study in rats, clinical observations in pups
       included reduced mobility, unkempt appearance, hunching, and/or tremors at
       the HDT (2000/3000 ppm = 178 mg/kg/day). At this treatment level, severe
       toxicity was observed in the parental animals, pup body weight was reduced,
       and pup survival was compromised.

#      Iprodione causes endocrine disruption, affecting the reproductive system,
       pituitary, adrenals, and/or thyroid in various studies.

(iii) Other Unknown  Factors:
                              25

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       #      Because of the lack of acute and subchronic neurotoxicity studies in rats,
              there was no evaluation of the nervous system following perfusion.  Findings
              in other studies that were suggestive of neurotoxicity could not be confirmed
              or refuted.

                     (6)    Determination of the FQPA Safety Factor

       The decision to evaluate the need for an additional safety factor to ensure the
protection of infants and children from exposure to iprodione, as required by FQPA, was
elevated to the OPP Division Directors, who met to discuss the iprodione FQPA Safety
Factor on April 7, 1997. The Division Directors decision and decision logic is summarized
below.

       It was determined that the additional lOx Safety Factor for the protection of infants
and children (as required) by FQPA should be reduced to 3x and the rationale  for reducing
the lOx factor to 3x are as follows:

       •       No enhanced susceptibility was seen in rat and rabbit developmental and the
              two generation reproduction study in rats.

       •       The critical endpoint for acute dietary risk assessment (decreased AGD) was
              seen at a high dose (120 mg/kg/day) and there were only marginal differences
              in the degree of decreased AGD between the doses 20 mg/kg/day (2.44), 120
              mg/kg/day (2.32) and 250 mg/kg/day (2.10) thus indicating the "true" NOEL
              could be higher than the one established at 20 mg/kg/day.

       •       The proposed mode of action of iprodione is  disruption of testosterone
              biosynthesis.

       •       The use of a realistic dietary exposure data (refined using monitoring data and
              percent crop treated).

       •       The  endpoints  selected  for both  the  acute  (AGD)  and  the  chronic
              (histopathology of male reproductive system) risk assessments  are based on
              developmental/reproductive effects.

       •       The uncertainty with regard to the pre/post natal exposure study requested by
              the FQARC which may confirm the effects seen in the standard developmental
              and/or reproductive studies.

       Of note, Rhone-Poulenc Ag Co., the current manufacturer of iprodione, disputes the
appropriateness of retaining the 3 X FQPA uncertainty factor since: (1) the Agency concluded
that there was not increased susceptibility to rat and rabbit fetuses following in  utero and/or
post natal exposure to iprodione; (2) marginal differences on AGD were only observed in the

                                     26

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presence of substantial maternal toxicity; (3) Rhone-Poulenc considers that no data gap exists
with regards to the pre/post natal effects of iprodione;  an acceptable  two-generation
reproduction study in rats having been completed as recently as 1991; and, (4) Rhone-Poulenc
believes that it is especially not appropriate to justify retaining a FQPA safety factor on the
acute RfD for a perceived data gap relating to a multi-generation reproduction study.

                     (7)    Application of the FQPA Safety Factor

              (i). Acute Dietary Risk Assessment. The FQPA Safely Factor will be applied
              for acute dietary risk assessment for Females 13 + only because the endpoint
              (decreased AGD) is an in utero effect occurring during prenatal exposure. An
              appropriate endpoint attributable to a single dose was not identified for the
              General Population including Infants and Children for this risk assessment.
              Since the  decreased AGD occurs during  in utero exposure, it is not an
              appropriate endpoint for acute dietary risk assessment of Infants and Children
              (i.e.,  the anogenital distance can not be altered after birth in Infants and
              Children).

              ii. Chronic Dietary Risk Assessment. The FQPA Safety Factor will be applied
              for chronic dietary  risk assessment for the General Population including
              Infants and Children since the endpoint is based on reproductive effects
              (histopathological lesions in the male reproductive organs).

              iii. Occupational Exposure.  The FQPA Safety Factor will not be applied to
              any occupational scenarios, as per Agency policy.

              iv. Residential Exposure.   The FQPA Safety Factor will be applied to
              residential exposure risk assessments for Female  13 + as well as the General
              Population including Infants and Children due to the potential exposure by
              these subpopulations based on the use pattern (ornamental lawn and turf) and
              the inhalation endpoint is based on reproductive effects in a chronic rat study
              (NOELof6.1mg/kg/day).

              b.      Toxicological Endpoints for Risk Assessment

                     (1)    Acute Dietary

       The HIARC on February 25, 1998 determined that the developmental NOEL of 20
mg/kg/day based on decreased anogenital distance (AGD) in male fetuses at 120 mg/kg/day
should be used for acute dietary  risk assessment.  This NOEL  is from  a  special rat
developmental study (MRID 44365001) which was designed to determine the impact of
iprodione on sexual differentiation. This endpoint applies only to females 13+ because the
endpoint (decreased AGD) is an in utero effect occurring during prenatal exposure.   An
appropriate  endpoint  attributable to a single  dose was  not identified for the General

                                    27

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Population including Infants and Children for this risk assessment. The target acute dietary
MOE for iprodione is 300, based on uncertainty factors of 10X for interspecies variability,
10X for intraspecies variability, and 3X for FQPA for the protection of infants and children.

       The HIARC selected the dose of 20 mg/kg/day from the  special rat study as a
conservative estimate for risk assessment, however, doubted if this dose represented a "true"
NOEL for the following reasons:  1) effects at the next higher dose (120 mg/kg/day, the
LOEL), consisted of only marginal decreases; 2) although the decrease in AGD at the LOEL
showed statistical significance, thebiological significance is questionable because of the extent
of the decreases seen between the NOEL (2.44ฑ0.14) and the LOEL (2.32ฑ0.12)  which
indicate that the "actual" no effect level could be higher, some  where in between these levels
(i.e, 20 and 120 mg/kg/day); 3) lack of evaluation of another critical endpoint (i.e., nipple
development, characterized as areolas/nipple anlagen in two strains of rats) which was
observed along with the decrease in AGD with Vinclozolin, a structurally related compound;
and 4) although AGD was not measured, another developmental toxicity study in rats
demonstrated a developmental NOEL of 90 mg/kg/day based  on delayed fetal development
(MRID 00162984).

       The HIARC noted that the Toxicological Endpoint Selection (TES) Committee
previously selected the NOEL of 90 mg/kg/day established in the 1986 study along with an
additional Uncertainty Factor of 3 due to the lack of data on the androgen deprivation effect.
This yielded a dose  (90-K3=30 mg/kg/day) which is comparable to the 20 mg/kg/day dose
selected for this risk assessment. The HIARC considered the earlier developmental toxicity
study as co-critical in the choice of the  toxicological endpoint for acute dietary risk
assessment.

       An MOE approach is being used for the iprodione acute dietary risk assessment for
consistency with the acute dietary risk assessments done from 1995 to 1997 for this chemical
for Special Review. Also, an MOE approach is used for ease of comparison with the Novigen
Acute Monte Carlo Dietary Risk Assessment conducted in 1997.

       At present the Agency uses an acute RfD approach for acute dietary risk assessments.
The percentage of the acute RfD is a measure of how close the high-end exposure comes to
the Reference Dose, and is calculated as the  ratio  of exposure (mg/kg/day) to the RfD
(mg/kg/day).  If this approach is taken, for iprodione, the FQPA Safety Factor of 3x will be
incorporated into the acute RfD for the subpopulation Females  13+ only because the endpoint
(decreased AGD) in an in utero effect. The acute RfD is calculated as follows:

       Acute RfD =  20 mg/kg/dav (NOEL^       =   0.06 mg/kg/day
                           300  (UF)

       The 300 UF includes inter-species variation (lOx), intra-species extrapolation (lOx),
and the FQPA Safety Factor (3x).
                                    28

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       However, as stated earlier, for iprodione, to ensure consistency with earlier risk
assessments, the present acute dietary risk  assessment is based on the MOE and as a
percentage of the acute RfD.  The acute RfD is presented here only as a reference value.

                     (2)    Chronic Reference Dose (RfD)

       The February 28, 1998 HIARC re-affirmed the dose  and endpoints selected for
establishing the chronic RfD in 1994. The chronic RfD was  based on  a NOEL of 6.1
mg/kg/day from a rat combined chronic toxi city /carcinogen! city study (MRID 42637801;
MRID 42787001]) based on histopathological lesions in the male reproductive system and
effects on the adrenal glands in males at 12.4 and in females at 16.5 mg/kg/day (LOEL). The
NOEL was adjusted with an uncertainty factor of 300 (10 x for inter-species extrapolation
and 10 x for intra-species variability and 3X for FQPA considerations). The chronic RfD was
determined to be 0.02 mg/kg/day.

Chronic RfD =        6.1 mg/kg/dav (NOEL^     =  0.02 mg/kg/day
                                  300 (UF)

       Iprodione has been reviewed by the F AO/WHO Joint Committee Meeting on Pesticide
Residues [JMPR]. The World Health Organization (WHO) established an acceptable daily
intake (ADI) of 0.3 mg/kg/day in 1977. This  ADI was revised to 0.2 mg/kg/day in 1992.

                     (3)    Carcinogenic Risk Assessment

       On November  19, 1997, EPA's Cancer Assessment Review Committee (CARC) in
accordance with the EPA Proposed Guidelines for Carcinogen Risk Assessment (April 10,
1996), classified iprodione  as a  "likely" human carcinogen  based on the combined
hepatocellular adenomas/ carcinomas  in mice and testicular tumors in male rats with a linear
low-dose  extrapolation approach and a 3/4s interspecies  scaling factor for human risk
characterization. For the combined hepatocellular adenomas/ carcinomas, the Qj*s are 8.7
x 10"3 for the male mouse and 5.07 x 10"3 for the female mouse. For the Ley dig cell tumors
in male rats, the Qt* is  4.39 x 10"2. The CARC determined that of these, the most potent Qt*
of 4.39 x 10"2 should be used for cancer risk assessments. Therefore, the Qt* of 4.39 x 10"2
should be used for estimating carcinogenic risk.

       Of note, Rhone-poulenc Ag Co. contends that cancer risk assessments for iprodione
should be conducted using  a margin of exposure (MOE) approach rather than a linear low
dose extrapolation model. This contention is based on the mechanistic data described in this
document and  recently submitted data which may demonstrate that iprodione suppresses
plasma testosterone levels with corresponding increases in plasma LH levels in vivo at a dose
equivalent to that which induced benign Leydig cell tumors in the chronic rat study.
According to Rhone-Poulenc, this data further substantiates the view that iprodione provokes
hormonal imbalances  in the rat which predisposes this  highly sensitive species to the
development of an increased incidence of benign Leydig cell tumors.  The dose-response for
this type of hormonally-mediated effect would be expected to be non-linear.

                                    29

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             c.     Occupational/Residential Exposure

                    (1)    Short- and Intermediate-Term Dermal - (1 day to several
                           months)

       The HIARC determined that short- and intermediate-term dermal risk assessments are
not required since no dermal or systemic toxicity was seen. No dermal or systemic toxicity
was  seen following repeated dermal  application  of  iprodione at 0,  100, 500  or 1000
mg/kg/day, 6  hours/day, 5 days/week over a three week period to male and female New
Zealand rabbits (MRID No. 42032301). The HIARC concurred with the TES Committee's
conclusions that there is no potential hazard via the dermal  route because of the lack of
systemic toxicity at the Limit-Dose (1000 mg/kg/day) and the demonstration of low (5%)
absorption via the dermal route.

                    (2)    Long-Term Dermal (Several Months to Life-Time)

       (A). Non-Cancer (Chronic) Effects. A NOEL of 6.1 mg/kg/day from a combined rat
chronic toxicity/carcinogenicity study (MRID Nos. 43308201  & 43000501) was chosen for
chronic dermal risk assessment. The NOEL of 6.1 mg/kg/day was based on histopathological
lesions in the male reproductive system and effects on the adrenal glands in males at 12.4 and
in females at 16.5 mg/kg/day (LOEL). This dose was selected since the current use pattern
(6 days/week for up to 180 days) indicates potential for Long-Term dermal exposures. This
oral NOEL with a dermal absorption factor of 5% should be used only for non-cancer dermal
risk assessments. Dermal exposure should not be combined with inhalation exposure since
a Long-Term inhalation risk assessment is not required.

       (B). Carcinogenic Effects.  The Qt* of 4.39 x 10"2 should be used for estimating
carcinogenic risk from occupational exposure.  The dermal and inhalation exposures  should
be combined and appropriate dermal (5%) and inhalation (100%) absorption factors  should
be used in carcinogenic risk assessments. This risk assessment is required.

                    (3)    Dermal Absorption

       The HIARC determined the dermal absorption factor for iprodione to be 5% at 10
hours.  This factor is necessary ONLY for Long-Term chronic and carcinogenic dermal risk
assessments since Short-and Intermediate-Term risk  assessments are  not required. This
dermal absorption factor is based on MRID No. 43535003.

                    (4)    Inhalation Exposure (Short and Intermediate-Term only)

       Except for an acute inhalation toxicity study, the results of which place  iprodione in
Toxicity Category IV (LC50 = 5.16 mg/L), no other studies are available via this route.  The
current use pattern (4 days/week up to several weeks) indicates a concern only for Short and

                                    30

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Intermediate-Term but not for Long-Term exposures via this route. Therefore, the HIARC
selected the doses only for Short and Intermediate-Term inhalation exposure risk assessments.

                           (a)    Short-Term Inhalation Exposure

       The Developmental NOEL of 20 mg/kg/day from the special rat developmental
toxicity study (MRTD No.44365001) was selected for short term inhalation risk assessment.
This NOEL is based on decreased AGD in male fetuses at 120 mg/kg/day (LOEL). The
inhalation exposure component (i.e., jig a.i/lb/day) using a 100% absorption rate (default
value) should be converted to an equivalent oral dose (mg/kg/day).  This converted oral dose
should then be compared to the NOEL identified above. Inhalation exposure should not be
combined with dermal exposure since a dermal risk assessment is not required.  This risk
assessment is required.

                           (b)    Intermediate-Term Inhalation Exposure

       The NOEL of 6.1 mg/kg/day from the rat combined Chronic Toxi city /Carcinogen! city
Study (MRIDNos.43308201 & 43000501). This NOEL is based on histopathological lesions
in the male reproductive system and effects on the adrenal glands in males at 12.4 and in
females at 16.5 mg/kg/day (LOEL).

       The inhalation unit exposure (in  jig a.i/lb/day) should be converted to an equivalent
oral dose (mg/kg/day) using a 100% absorption rate (default value). This converted oral dose
should then be compared to the NOEL identified above. Inhalation exposure should not be
combined with dermal exposure since a dermal risk assessment is not required.

                           (c)    Long-Term Exposure

       The current use pattern does not indicate a concern for Long-Term exposure or risk.
This risk  assessment is not required.

             d.     Target  Margin  of  Exposure for  Occupational/Residential
                    Exposures

       A Margin of Exposure (MOE) of 100 is adequate for occupational exposure risk
assessments. However,  because of the FQPA Safety Factor, a MOE of 300 is required for
residential exposure risk  assessments  for the  general population including infants and
children.

             e.     Recommendation for Aggregate Exposure Risk Assessments

       For acute aggregate exposure risk assessment, combine the high end exposure values
from food + water and compare it  to the oral NOEL to calculate the MOE or percent acute
RfD.
                                   31

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              For short and intermediate aggregate exposure risk assessment, combine the average
       exposure values from food + water together with the exposure from inhalation route (100%
       absorption) only and compare it to the oral NOELs to calculate the MOE (dermal risk
       assessments are not required for these exposure periods).

              For chronic aggregate exposure risk assessment, combine the average exposure values
       from food + water together. There are no chronic residential use scenarios to include in this
       risk assessment.  The  doses and toxicological  endpoints selected  for  various exposure
       scenarios are summarized in Table 5.

Table 5. Summary of Toxicological Endpoints to be used for Iprodione Risk Assessment
Exposure Scenario
Acute Dietary
Chronic Dietary
Carcinogenicity
(Dietary)
Short-Term
(Dermal)
Intermediate-Term
(Dermal)
Long-Term
(Dermal) ^
Non-Cancer
Long-Term
(Dermal) 3 Cancer
Short-Term
(Inhalation)3-"
Intermediate-Term
(Inhalation)3-1'
Long-Term
(Inhalation)
Dose (mg/kg/day)
Developmental NOEL=20
UF= 100 and 3X for FQPA
NOEL=6.1
UF=100 and 3x for FQPA
Qi*=
4.39 xlO-2
Not Applicable
Not Applicable
OralNOEL=6.1
Qi*=
4.39xlO'2
Oral Developmental
NOEL=20
UF=100 and 3x for FQPA
OralNOEL=6.1
UF=100 and 3x for FQPA
Not Applicable
Endpoint
Decreased anogenital distance in male pups.
Study
Developmental- Rat
Acute FQPA RfD = 0.06 mg/kg/day
Histopathological lesions in the male
reproductive system and the adrenal glands in
both sexes.
Combined Chronic Toxicity/
Carcinogenicity -Rat
Chronic FQPA RfD = 0.02 mg/kg/day
Iprodione is classified as a "Likely" human carcinogen with a low-dose
extrapolation approach for human risk assessment.
No dermal or systemic toxicity seen at the Limit-Dose in a 21-day dermal toxicity
study in rabbits. This risk assessment is not required.
No dermal or systemic toxicity seen at the Limit-Dose in a 21-day dermal toxicity
study in rabbits. This risk assessment is not required.
Histopathological lesions in the male
reproductive system and the adrenal glands in
both sexes.
Combined Chronic Toxicity/
Carcinogenicity-Rat
Iprodione is classified as a "Likely" human carcinogen with a low-dose
extrapolation approach for human risk assessment.
Decreased anogenital distance in male pups.
Histopathological lesions in the male
reproductive system and the adrenal glands in
both sexes.
Developmental-Rat
Combined Chronic Toxicity/
Carcinogenicity-Rat
Based on the use pattern, there is no concern for exposure or risk. This risk
assessment is not required.
a = Appropriate route-to-route extrapolation should be performed (i.e., a dermal absorption factor of 5% and an inhalation absorption factor of 100% used
for conversion to oral equivalent doses and then compared to the oral NOELs).
b = MOE=100 for occupational exposure.

              3.      Occupational and Residential Exposure and Risk Assessment

                      a.      Occupational-use sites

              Iprodione has been registered for occupational-use on commercial/industrial lawns,
       golf course turf, ornamentals and shade trees, ornamental herbaceous plants, ornamental
       woody shrubs and vines, and food crops.  The occupational crops use sites have been grouped
       as follows:
                                             32

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       •      Agricultural  Crops:, including almonds,  apricots, cherries, nectarines,
              peaches, pecans, plums, prunes, beans (dried, lima,  and snap), blackberries,
              blueberries, broccoli, bushberries, caneberries, carrots, garlic, grapes, ginseng,
              gooseberries, huckleberries, lettuce (head and leaf), loganberries, mustard
              cabbage, Chinese cabbage, dry bulb onions, peanuts, potatoes, raspberries,
              and strawberries.

       •      Ornamentals: including flowering trees and shrubs, woody shrubs and vines,
              evergreens, flowering and nonflowering plants,  ground covers and shade
              trees.

       •      Turfgrass:  including sod farms, golf courses and institutional lawn areas of
              bentgrass, blue grass, Bermuda grass, St. Augustine grass, rye grass, fine
              fescue or tall  fescue.

              b.     Residential-use sites

       Potential residential and non-occupational use sites may include residential sites (e.g.,
exposure to fungicide use on fruit and  vegetable gardens, ornamentals,  and turfgrass),
professional uses  at residential sites (e.g.,  fungicide use  on trees, shrubs, and  other
ornamentals, application to lawns), and other sites where non-occupational exposure may
occur (e.g., turfgrass in golf courses, parks, residential and recreational areas).  The non-
occupational crops use sites  have been grouped as follows:

       •      Fruit/Nut Trees: including almonds, apricots, cherries, nectarines, peaches,
              and plums.

       •      Small Fruit/Vegetable Garden Crops: including beans (dried, lima,  and
              snap), blackberries, blueberries, broccoli, bushberries, caneberries, carrots,
              garlic, grapes, ginseng, gooseberries, huckleberries, lettuce (head and leaf),
              loganberries,  mustard cabbage, Chinese cabbage, dry bulb onions, peanuts,
              potatoes, raspberries, and strawberries.

       •      Ornamentals at Residences: including shade trees, evergreens and flowering
              and non-flowering shrubs.

       •      Turfgrass:  including residential lawn areas.

              c.     Occupational Exposures & Risks

       EPA has determined, based on current use patterns, that there are potential exposures
to workers handling iprodione products, as well as to workers who come into contact with
treated surfaces following applications of iprodione products.

                     (1)     Handler Exposures & Risks

       EPA has determined that there are potential exposures to mixers, loaders, applicators,
or other handlers during usual use-patterns associated with  iprodione.

                                     33

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                     (2)     Handler Exposure Scenarios

       Based on the use patterns, 19 major handler exposure scenarios were identified for
iprodione:  (la) mixing, loading liquids for aerial/chemigation application; (Ib) mixing,
loading liquids for groundboom application; (Ic) mixing, loading liquids for orchard airblast
sprayer  application;  (Id)  mixing,  loading  liquids  for professional  application  to
turfgrass/ornamentals using a low pressure/high volume handgun;  (2a) mixing, loading
wettable powder for aerial/chemigation application; (2b) mixing, loading wettable powder for
groundboom  application; (2c) mixing, loading wettable powder for orchard airblast sprayer
application;  (2d)  mixing,  loading wettable  powder  for professional   applicator  to
turfgrass/ornamentals using a low pressure/high volume handgun; (3a) mixing, loading dry
flowables for chemigation application; (3b) mixing, loading dry flowables for groundboom
application; (4) loading granulars for tractor-drawn spreader application;(5) applying sprays
with fixed-wing aircraft; (6)  applying sprays with a helicopter; (7) applying sprays using a
groundboom  sprayer;  (8) applying to orchards with an airblast sprayer; (9) applying with a
low pressure/high volume handgun to turfgrass/ornamentals; (10) applying granulars with a
tractor-drawn spreader; (11) mixing, loading, applying sprays  using a low pressure hand
wand; (12) mixing, loading, applying sprays using a high pressure hand wand (13) mixing,
loading, applying sprays using a backpack sprayer; (14) loading/ applying granulars using a
belly grinder; (15) loading/  applying granulars with a push-type granular spreader; (16)
mixing, loading, applying as a seed soak treatment;  (17) mixing, loading,  applying as a
commercial seed treatment in slurry form; (18) mixing, loading, applying solutions as a dip
treatment; and (19) flagging during aerial spray application.

                     (3)     Handler Exposure Scenarios — Data and Assumptions

       No chemical-specific  handler exposure  data were submitted in support of the
reregi strati on of iprodione. Therefore, an exposure assessment was developed for scenarios
where  appropriate surrogate  data are available, using the Pesticide Handlers Exposure
Database (PHED)  Version 1.1 (USEPA 1997d).  Table  6 summarizes the caveats and
parameters specific to the  surrogate data used for each scenario  and  corresponding
exposure/risk assessment.  These caveats include the source of the data and an assessment of
the overall quality of the data.  The assessment of data quality is based on the number of
observations  and the available quality control data.  The quality control data are based on a
grading criteria established by the PHED task force.

       The following assumptions and factors were used in order to complete this exposure
assessment:

•      Average body weight of an adult handler is 70 kg. This body weight is used in the
       intermediate-term inhalation and cancer assessments.  A body weight of 60 kg is used
       in the short-term inhalation  assessment  because the  NOEL is based  on  a
       developmental effect.
                                     34

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•      Average work day interval represents an 8 hour workday (e.g., the acres treated or
       volume of spray solution prepared in a typical day).
•      Daily acres and volumes (as appropriate) to be treated in each scenario.  These are
       based on the ORE Science Advisory Council estimates of areas treated per day for the
       broad categories of application methods and equipment considered.  They include:
           350 acres for aerial and chemigation applications in agricultural settings and to
           turfgrass (including flaggers supporting aerial applications)
           80 acres  for groundboom  spraying  of  agricultural  areas, sod farms, and
           ornamental field stock
           80 acres for tractor-drawn spreader application to turfgrass
           40 acres for orchard airblast application
           5 acres for application to turfgrass using a low pressure/high volume handgun
           and to turf and ornamentals with a low pressure handwand and to turf with a
           high pressure handwand
           5 acres for application of granular formulations to turfgrass using a push-type
           spreader or belly grinder  (e.g., golf courses)
           40 gallons of spray to turf and ornamentals using a low pressure handwand or
           backpack sprayer
           1,000 gallons of spray to  ornamentals using a high pressure handwand

•      For drench treatments no PHED data were available; thus, as a surrogate, the PHED
       unit exposure data for groundboom spray was used to calculate dermal and inhalation
       exposure.

•      Calculations are completed at the maximum  application rates for specific crops
       recommended by the available iprodione labels to bracket risk levels associated with
       the various use patterns. No data were provided concerning the "typical" application
       rates used for iprodione.

•      Due to  a lack of scenario-specific data, EPA often must calculate unit exposure values
       using generic protection factors (PF) to represent various risk mitigation options (i.e.,
       the use of personal protective equipment  (PPE) and engineering controls).  PPE
       protection factors include those representing a double layer of clothing (50 percent
       PF for body exposure), chemical resistant gloves (90 percent PF for hand exposure),
       and respiratory protection (80 percent PF for use of dust/mist mask). Engineering
       controls are generally assigned a PF of 80 percent.

                     (4)   Handler Exposure  and Non-Cancer Risk Estimates

       Handler exposure assessments are completed by EPA using a baseline  exposure
scenario and, if required, increasing levels of risk mitigation (PPE and engineering controls)
to achieve an acceptable margin of exposure (assumed to be MOE 100 or greater) or cancer
risk (l.OE-4 to l.OE-6 for workers).  The baseline scenario generally represents a handler
wearing long pants, a long-sleeved shirt, and no chemical-resistant gloves.  The following

                                     35

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      tables present exposure and risk estimates for the handling of iprodione. Table 7 presents the
      short-term and intermediate-term inhalation risks at baseline. Table 8 presents the PPE-level
      risks for those scenarios where MOEs are less than 100  at baseline. Table 9 presents the
      short-term and intermediate-term  inhalation risks for water soluble bag formulations and
      applications employing closed cockpit aircraft.

              In calculations of short-term and  intermediate-term inhalation risks, potential daily
      exposures were calculated using the following formula:
        Daily Inhalation Exposure ———
                           I  day
        Unit Exposure  —	  x Conversion Factor  	—— x Use Rate  	 x Daily Acres Treated  	
                   (ibai)                ( 1,000 u.gj          ( A  I                  (day)
              The potential baseline short-term and  intermediate-term  inhalation doses  were
      calculated using the following formulas:
     Short-term Daily Inhalation Dose  —	  = Short-term Daily Inhalation Exposure  —-— x  	
                              1, kg/day}                              ( day )   ( Body Wei
        Weight (kg)
              For iprodione, the short-term inhalation dose was calculated using a 60 kg body
      weight, while  the intermediate-term inhalation dose uses a 70  kg body  weight  in the
      calculations.  An inhalation absorption rate of 100 percent was used in the calculations.
Intermediate-term Daily Inhalation Dose  —	 = Intermediate-term Daily Inhalation Exposure  —	  x
                              \ kg/day)                                    (  day }  \
                                                                                       1
day I   \ Body Weight (kg))
              For iprodione, the short-term inhalation MOE was calculated using a NOEL of 20
      mg/kg/day, and the intermediate-term inhalation MOE was calculated using a NOEL of 6.1
      mg/kg/day. The baseline short-term and intermediate-term inhalation MOEs were calculated
      using the following formulas:

                                                 Short-term NOEL   ™g 1
                     Short-term Inhalation MOE = 	^ kg/day)	
                                           Short-term Inhalation Daily Dose	—
                                                                    I kg/day)



                                                 Intermediate-term NOEL   mg  j
                Intermediate-term Inhalation MOE - 	i———ฅ-L	—
                                           Intermediate-term Inhalation Daily Dose  	——
                                                                         ( kg/day)
                                               36

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Table 6. Exposure Scenario Descriptions for the Use of Iprodione
Exposure Scenario
(Number)
Data Source
Standard Assumptions3
(8-hr work day)
Commentsb
Mixer/Loader Descriptors
Mixing/Loading Liquid
Formulations
(la/lb/lc/ld)
Mixing/Loading Wettable
Powders(2a/2b/2c/2d)
Mixing/Loading Dry
Flowable Formulations
(3a and 3b)
Loading Granular
Formulations (4)
PHEDV1.1
PHED
VI. 1
PHED
VI. 1
PHED VI. 1
350 acres for aerial, 350 acres for
chemigation of sod farms and
agriculture, 100 acres for chemigation
of ornamental nurseries, 80 acres for
groundboom in agriculture,
ornamental nurseries and turfgrass.
40 acres for orchard airblast
applications and 5 acres for treatment
of ornamentals and turf when using a
low pressure/high volume handgun
350 acres for aerial and chemigation
of agriculture, 80 acres for
groundboom in agriculture, 40 acres
for orchard airblast applications
350 acres for chemigation of turfgrass,
80 acres for groundboom application
to ornamentals, turfgrass and tractor-
drawn spreader application to
turfgrass
80 acres for tractor drawn spreaders
for turfgrass
Baseline: Hand, dermal, and inhalation = AB grades. Hand = 53 replicates; Dermal = 72 to 122
replicates; and Inhalation = 85 replicates. High confidence in hand, dermal and inhalation data. No
protection factor was needed to define the unit exposure value.
PPE: The same dermal data are used as for the baseline coupled with a 50% protection factor to account
for an additional layer of clothing. Hands = AB grades. Hands = 59 replicates. High confidence in hands,
dermal data.
Engineering Controls: Mechanical transfer method. Hands, dermal and inhalation unit exposures = AB
grades. Hands =31 replicates; dermal = 16 to 22 replicates, and inhalation = 27 replicates. High
confidence in dermal, hand and inhalation data. Gloves were worn during the use of the engineering
controls.
Baseline: Hands, dermal and inhalation = ABC grades. Hands = 7 replicates, dermal = 22-45 replicates
and inhalation = 44 replicates. Low confidence in dermal, hands data due to the low number of hand
replicates. Medium confidence in inhalation data.
PPE: Gloved data for hands = ABC grades. Hands = 24 replicates. Medium confidence in hands data.
Dermal values calculated by applying a 50% protection factor to baseline values to account for an
additional layer of clothing. A 5-fold PF (e.g. 80% PF was applied to the baseline inhalation data).
Engineering Controls: Water soluble bags. Dermal and hand data = AB grades. Inhalation = All grade.
Inhalation =15 replicates, dermal = 6-15 replicates and hands = 5 replicates. Low confidence in the
dermal, hands and inhalation data.
Baseline: Hands, dermal and inhalation = AB grades. Low confidence in hands, dermal data. High
confidence in inhalation data. Hand = 7 replicates, dermal = 16-26 replicates and inhalation = 23
replicates.
PPE: Gloved data for hands = AB grade. High confidence in hands data. Hands = 21 replicates.
Dermal values calculated by applying a 50% protection factor to baseline values to account for an
additional layer of clothing. A 5-fold PF (e.g. 80% PF was applied to the baseline inhalation data.
Engineering Controls: Based on scenario for wettable powders (water soluble bags). See above
scenario.
Baseline: Hands = All grade, dermal = ABC grade, and inhalation = AB grade. Hands =10 replicates;
dermal = 33 to 78 replicates; and inhalation = 58 replicates. Low confidence in dermal/ hand data. High
confidence in inhalation data.
PPE: Baseline assessment sufficient
Engineering Controls: Baseline assessment sufficient
Applicator Descriptors
Applying Sprays with a
Fixed- Wing Aircraft (5)
PHED
VI. 1
350 acres for aerial
Baseline: No data
PPE: No data
Engineering Controls: Hands = AB grade, dermal and inhalation = ABC grade. Medium confidence in
hands/dermal and inhalation data. Hands = 34 replicates, dermal = 24-48 replicates, and inhalation = 23
replicates.
                                                                    37

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Exposure Scenario
(Number)
Applying Sprays with a
Helicopter (6)
Applying Sprays with a
Groundboom Sprayer (7)
Applying to Orchards
with an Airblast Sprayer
(8)
Applying with a Low
Pressure/High Volume
Handgun to Turfgrass (9)
Applying Granulars with
a Tractor-Drawn
Spreader (10)
Data Source
PHED
VI. 1
PHED VI. 1
PHED
VI. 1
PHED VI. 1
PHED VI. 1
Standard Assumptions3
(8-hr work day)
350 acres for aerial
80 acres in agricultural, ornamental
and turfgrass settings
40 acres for orchard spraying
5 acres for turfgrass
80 acres for turfgrass
Commentsb
Baseline: No data
PPE: No data
Engineering Controls: Hands and inhalation = A grade, dermal = C grade. Low confidence in inhalation
data, and extremely low confidence in hands and dermal data due to very low number of replicates. Hands
= 2 replicates, dermal = 3 replicates, and inhalation = 3 replicates.
Baseline: Hand, dermal, and inhalation = AB grades. Hands = 29 replicates, dermal = 23 to 42
replicates, and inhalation = 22 replicates. High confidence in hand, dermal, and inhalation data.
PPE: Baseline assessment sufficient
Engineering Controls: Baseline assessment sufficient
Baseline: Hand, dermal and inhalation are AB grade. Hands 22 replicates, dermal = 32 to 49 replicates,
and inhalation = 47 replicates. High confidence in hand, dermal and inhalation data.
PPE: Baseline assessment sufficient
Engineering Controls: Baseline assessment sufficient
Baseline: No hand data. See PPE. Inhalation data are AB grades with 14 replicates and low to medium
confidence.
PPE: Dermal and inhalation data are C grade with low confidence. Hands = 14 replicates; dermal = 0-14
replicates.
Engineering Controls: Not feasible.
Baseline: Hands, dermal and inhalation = AB grades. Low confidence in hands, dermal and inhalation
data. Hands = 5 replicates, dermal =1-5 replicates and inhalation = 5 replicates.
PPE: Baseline assessment sufficient
Engineering Controls: Baseline assessment sufficient
Mixer/Loader/Applicator Descriptors
Mixing/Loading/Applying
with a Low Pressure
Handwand(ll)
Mixing/Loading/Applying
with a High Pressure
Handwand (12)
PHED VI. 1
PHED VI. 1
5 acres for turfgrass application and
40 gallons for turf and ornamental use
1 ,000 gallons for ornamentals and 5
acres for agricultural settings.
Baseline: Dermal and inhalation = ABC grade, hands = All grades. Low confidence in hands/dermal
data. Medium confidence in inhalation data. Hands =70 replicates, dermal =9-80 replicates and
inhalation =80 replicates.
PPE: Hands = ABC grade with 10 replicates. Low confidence in dermal/hand data. The same dermal
data are used as for the baseline.
Engineering Controls: Not feasible
Baseline: Dermal = AB grades, inhalation = A grade. Dermal = 7-13 replicates; inhalation =13
replicates. Gloved data was used to calculate the no gloved hand data, assuming gloves provide 90%
protection. Hands = C grade with 13 replicates. Low confidence in hand, dermal, and inhalation data.
Baseline data includes use of chemical-resistant gloves.
PPE: The same dermal data are used as for the baseline coupled with a 50% protection factor to account
for an additional layer of clothing. Hands data = C grade with 13 replicates. Low confidence in hand and
dermal data. A 5-fold PF (e.g. 80% PF) was applied to the baseline inhalation data.
Engineering Controls: Not feasible
38

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Exposure Scenario
(Number)
Mixing/Loading/Applying
with a Backpack Sprayer
(13)
Loading/Applying
Granulars Using a Belly
Grinder (14)
Loading/Applying Using
a Push- Type Granular
Spreader (15)
Flagging Spray
Applications (19)
Data Source
PHED VI. 1
PHEDV1.1
PHED VI. 1
PHED VI. 1
Standard Assumptions3
(8-hr work day)
5 acres for turf use, and 40 gallons for
turf and ornamental use
5 acres for turfgrass application
5 acres for turfgrass application
350 acres
Commentsb
Baseline: No hands data. See PPE. Inhalation = A grade, with 1 1 replicates and low confidence.
PPE: Dermal = AB grades. Hands = C grade. Dermal = 9-11 replicates, hands =11 replicates. 80% PF
was applied to baseline inhalation data to account for use of dust mist respirator.
Engineering Controls: Not feasible.
Baseline: Hands and dermal = ABC grades and inhalation = AB grade. Medium confidence in
hands/dermal data and high confidence in inhalation data. Hands = 23 replicates, dermal = 29-45
replicates and inhalation = 40 replicates.
PPE: = Gloved data for hands = All grades with 20 replicates. Low confidence in hand data. The dermal
data are taken from the baseline coupled with a 50% protection factor to account for an additional layer of
clothing. A 5-fold protection factor (80% PF) was applied to baseline inhalation data to account for use of
dust mist respirator.
Engineering Controls: Not feasible
Baseline: Hand and dermal = C grades, and inhalation = B grade. Hand =15 replicates, dermal = 0-15
replicates, and inhalation =15 replicates. Low confidence in hand and dermal data, and high confidence
in inhalation data.
PPE: The same dermal and hand data are used as for the baseline coupled with a 90% protection factor to
account for the use of chemical resistant gloves.
Engineering Controls: Not feasible.
Baseline: Hands, dermal and inhalation data = AB grades. High confidence in dermal, hands and
inhalation. Hands = 30 replicates, Inhalation = 28 replicates, and dermal = 18-28 replicates.
PPE: Baseline assessment sufficient
Engineering Controls: Baseline assessment sufficient
All Standard Assumptions are based on an 8-hour work day as estimated by EPA.
All handler exposure assessments in this document are based on the "Best Available" data as defined by the PHED SOP for meeting Subdivision U Guidelines (i.e., completing
exposure assessments). Best available grades are assigned to data as follows: matrices with A and B grade data (i.e., Acceptable Grade Data) and a minimum of 15 replicates;
if not available, then grades A, B and C data and a minimum of 15 replicates; if not available, then all data regardless of the quality (i.e., All Grade Data) and number of replicates.
High quality data with a protection factor take precedence over low quality data with no protection factor.  Generic data confidence categories are assigned as follows:
High    = grades A and B and 15 or more replicates per body part
Medium = grades A, B, and C and  15 or more replicates per body part
Low     = any run that included D or E grade data or has less than 15 replicates per body part.
                                                                           39

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Table 7.  Occupational Short-term and Intermediate-term Inhalation Risks from Iprodione at Baseline
Exposure Scenario (Seen. #)
Baseline
Inhalation Unit
Exposure3
0/g/lb ai)
Range of
Application
Ratesb
(Ib ai/A)
Crop Type or
Target0
Amount
Handled
per Dayd
Baseline Daily
Inhalation
Exposure6
(mg/day)
Short-term
Baseline Daily
Inhalation Dosef
(mg/kg/day)
Int.-term
Baseline Daily
Inhalation Dose8
(mg/kg/day)
Baseline Short-
term Inhalation
MOEh
(mg/day)
Mixer/Loader Risk
Mixing/Loading Liquids for Aerial/Chemigation Application (la)
Mixing/Loading Liquids for Groundboom Application (Ib)
Mixing/Loading Liquid for Orchard Airblast Sprayer Application (Ic)
Mixing/Loading Liquids for Professional Application to Turf Using a
Low Pressure/High Volume Handgun (Id)
Mixing/Loading Wettable Powder for Aerial/Chemigation Application
(2a)
Mixing/Loading Wettable Powder for Groundboom Application (2b)
Mixing/Loading Wettable Powder for Orchard Airblast Sprayer
Application (2c)
Mixing/Loading Wettable Powder for Professional Application to Turf using
a Low pressure/High Volume Handgun (2d)
Mixing/Loading Dry Flowable for Chemigation Application (3a)
Mixing/Loading Dry Flowable Groundboom Application (3b)
Loading Granulars for Tractor-Drawn Spreader Application (4)
1.2
1.2
1.2
1.2
43
43
43
43
0.77
0.77
1.7
0.51bai/A
1 Ib ai/A
5. 5 Ib ai/A
1.41bai/A
0.27 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
4 Ib ai/A
5. 5 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
5. 5 Ib ai/A
0.51bai/A
1 Ib ai/A
0.51bai/A
1 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
5. 5 Ib ai/A
5. 5 Ib ai/A
1 Ib ai/A
5. 5 Ib ai/A
0.68 Ib ai/A
1.41bai/A
4. 1 Ib ai/A
Ag
Turf
Ornamentals
Ag
Ornamentals
Turf
Ag
Ornamentals
Turf
Ag
Ag
Ag
Ornamental
Turf
Turf
Ornamentals
Turf
Turf
350 acres

100 acres
80 acres
80 acres

40 acres
5 acres

350 acres
80 acres
40 acres
5
acres
350 acres
80 acres
80 acres
80 acres
0.21
0.42
2.3
0.17
0.026
0.048
0.096
0.13
0.38
0.53
0.024
0.048
0.0084
0.033
7.5
15.0
1.7
3.4
0.86
1.7
0.30
1.2
1.5
0.062
0.34
0.092
0.19
0.56
0.0035
0.0070
0.038
0.0028
0.00043
0.00080
0.0016
0.0022
0.0063
0.0088
0.00040
0.00080
0.00014
0.00055
0.13
0.25
0.028
0.057
0.014
0.028
0.0050
0.020
0.025
0.0010
0.0057
0.0015
0.0032
0.0093
0.0030
0.0060
0.033
0.0024
0.00037
0.00069
0.0014
0.0019
0.0054
0.0076
0.00034
0.00069
0.00012
0.00047
0.11
0.21
0.024
0.049
0.012
0.024
0.0043
0.017
0.021
0.00089
0.0049
0.0013
0.0027
0.0080
5,700
2,900
530
7,100
47,000
25,000
13,000
9,100
3,200
2,300
50,000
25,000
140,000
36,000
150
80
710
350
1,400
710
4,000
1,000
800
20,000
3,500
13,000
6,300
2,200
Applicator Exposure
Applying Sprays with a Fixed- Wing Aircraft (5)
No Data
See
Eng. Con.
0.51bai/A
1 Ib ai/A
Ag
350 acres
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
Baseline hit-
term Inhalation
MOE1
(mg/day)

2,000
1,000
180
2,500
16,000
8,800
4,400
3,200
1,100
800
18,000
8,800
51,000
13,000
55
29
250
120
510
250
1,400
360
290
6,900
1,200
4,700
2,300
760

See Eng. Con.
See Eng. Con.
                                                                           40

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Exposure Scenario (Seen. #)
Applying Sprays with a Helicopter (6)
Applying Sprays with a Groundboom Sprayer (7)
Applying to Orchards with an Airblast Sprayer (8)
Applying with a Low Pressure/High Volume Handgun to Turfgrass (9)
Applying Granulars with a Tractor-Drawn Spreader (10)
Baseline
Inhalation Unit
Exposure3
0/g/lb ai)
No Data
See
Eng. Con.
0.74
4.5
1.4
1.2
Range of
Application
Ratesb
(Ib ai/A)
0.51bai/A
1 Ib ai/A
0.27 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
4 Ib ai/A
5. 5 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
5. 5 Ib ai/A
0.68 Ib ai/A
1.41bai/A
4. 1 Ib ai/A
Crop Type or
Target0
Ag
Ag
Ornamentals
Turf
Ag
Ornamentals
Turf
Turf
Amount
Handled
per Dayd
350 acres
80 acres
80 acres
80 acres
40 acres


80 acres
Baseline Daily
Inhalation
Exposure6
(mg/day)
See Eng. Con.
See Eng. Con.
0.016
0.030
0.059
0.083
0.24
0.33
0.090
0.18
0.0098
0.039
0.065
0.13
0.39
Short-term
Baseline Daily
Inhalation Dosef
(mg/kg/day)
See Eng. Con.
See Eng. Con.
0.00027
0.00050
0.00098
0.0014
0.0040
0.0055
0.0015
0.0030
0.00016
0.00064
0.0011
0.0022
0.0065
Int.-term
Baseline Daily
Inhalation Dose8
(mg/kg/day)
See Eng. Con.
See Eng. Con.
0.00023
0.00043
0.00084
0.0012
0.0034
0.0047
0.0013
0.0026
0.00014
0.00055
0.00093
0.0019
0.0056
Baseline Short-
term Inhalation
MOEh
(mg/day)
See Eng. Con.
See Eng. Con.
74,000
40,000
20,000
14,000
5,000
3,600
13,000
6,700
120,000
31,000
18,000
9,100
3,100
Mixer/Loader/Applicator Exposure
Mixing/Loading/Applying Sprays with a Low Pressure Handwand (11)
Mixing/Loading/Applying Sprays with a High Pressure Handwand (12)
Mixing/Loading/Applying Using a Backpack Sprayer (13)
Loading/ Applying Granulars Using a Belly Grinder (14)
Loading/ Applying Using a Push- Type Granular Spreader (15)
Mixing/Loading/Applying as a Seed Soak Treatment (16)
30
120
30
62
6.3
No Data
0.002 Ib
ai/gal
0.01 Ib ai/gal
5. 5 Ib ai/A
0.51bai/A
1 Ib ai/A
0.002 Ib
ai/gal
0.01 Ib ai/gal
0.002 Ib
ai/gal
0.01 Ib ai/gal
5. 5 Ib ai/A
0.68 Ib ai/A
1.41bai/A
4. 1 Ib ai/A
0.68 Ib ai/A
1.41bai/A
4. 1 Ib ai/A
No Data
Turf&
Ornamentals
Turf
Ag
Ornamentals
Turf&
Ornamentals
Turf
Turf
Turf
No Data
40 gallons
5 acres
5 acres
1,000
gallons
40 gallons
5 acres
5 acres
5 acres
No Data
0.0024
0.012
0.83
0.30
0.60
0.24
1.2
0.0024
0.012
0.83
0.21
0.43
1.3
0.0021
0.044
0.13
No Data
0.000040
0.00020
0.014
0.0050
0.010
0.0040
0.020
0.000040
0.00020
0.014
0.0035
0.0072
0.022
0.000035
0.00073
0.0022
No Data
0.000034
0.00017
0.012
0.0043
0.0086
0.0034
0.017
0.000034
0.00017
0.012
0.0030
0.0061
0.019
0.000030
0.00063
0.0019
No Data
500,000
100,000
1,400
4,000
2,000
5,000
1,000
500,000
100,000
1,400
5,700
2,800
910
57,000
27,000
9,100
No Data
Baseline hit-
term Inhalation
MOE1
(mg/day)
See Eng. Con.
See Eng. Con.
27,000
14,000
7,300
5,100
1,800
1,300
4,700
2,300
44,000
11,000
6,600
3,200
1,100

180,000
36,000
510
1,400
710
1,800
360
180,000
36,000
510
2,000
1,000
320
20,000
9,700
3,200
No Data
41

-------
Exposure Scenario (Seen. #)
Mixing/Loading/Applying as a Commercial Seed Treatment in Slurry
Form (17)
Mixing/Loading/Applying Solution as a Dip Treatment (18)
Baseline
Inhalation Unit
Exposure3
(Mg/lb ai)
No Data
No Data
Range of
Application
Ratesb
(Ib ai/A)
No Data
No Data
Crop Type or
Target0
No Data
No Data
Amount
Handled
per Dayd
No Data
No Data
Baseline Daily
Inhalation
Exposure6
(mg/day)
No Data
No Data
Short-term
Baseline Daily
Inhalation Dosef
(mg/kg/day)
No Data
No Data
Int.-term
Baseline Daily
Inhalation Dose8
(mg/kg/day)
No Data
No Data
Baseline Short-
term Inhalation
MOEh
(mg/day)
No Data
No Data
Flagger Exposure
Flagging Spray Applications (19)
0.35
0.51bai/A
1 Ib ai/A
Ag
350 acres
0.061
0.12
0.0010
0.0020
0.00087
0.0017
20,000
10,000
Baseline hit-
term Inhalation
MOE1
(mg/day)
No Data
No Data

7,000
3,600
     Footnotes:
     a
     b
  Baseline inhalation unit exposure reflects no respiratory protection.
  Application rates come from values found in the LUIS report and on Iprodione labels.  For some scenarios, a range of application rates is used to represent different crops. For example:
  (1)    0.27 Ib ai/A applies to the in-furrow spray treatment of cotton during planting [EPA Reg. No. 264-482, 264-453].
  (2)    0.5 Ib ai/A applies to almonds, rice (aerial), Chinese mustard and dry bulb onions [EPA Reg. No. 264-482, 264-520].
  (3)    1 Ib ai/A applies to stone fruits, potatoes, peanuts, broccoli, lettuce and carrots [EPA Reg. 264-482].
  Crop Type or Target provides a general description of the intended uses of various products containing Iprodione. Separate categories are presented because of the distinct differences in application rates and acres treated.
 Ag = agricultural crops and Turf =turfgrass including sod-farms, institutional areas and golf courses.  Ornamentals = includes greenhouse, field, landscape, and conifer nurseries.
  Amount Handled Per Day values are from the EPA estimates of acreage treated, or volume handled in a single day for each exposure scenario of concern based on the application method.
  Baseline Daily Inhalation Exposure (mg/day) = Unit Exposure (ug/lb ai) * (1 mg/1000 ug) Conversion * Application Rate (Ib ai/A or Ib ai/gallon) * Amount Handled Per Day (acres/day or gallons/day).
  Short-term Baseline Daily Inhalation Dose (mg/kg/day) = Baseline Daily Inhalation Exposure (mg/day) / 60 (Body Weight).
  Intermediate-term Baseline Daily Inhalation Dose (mg/kg/day) = Baseline Daily Inhalation Exposure (mg/day) / 70 (Body Weight).
  Baseline Short-term Inhalation MOE (mg/day) = NOEL (20 mg/kg/day) / Short-term Baseline Inhalation Dose (mg/kg/day).
  Baseline Intermediate-term Inhalation MOE (mg/day) = NOEL (6.1 mg/kg/day) / Intermediate-term Baseline Inhalation Dose (mg/kg/day).
Table 8.  Occupational Short-term and Intermediate-term Inhalation Risks from Iprodione with PPE(For Scenarios with MOE's <100 at Baseline)

Exposure Scenario (Seen. #)



PPE
Inhalation
Unit
Exposure3
Og/lb ai)
Range of
Application
Ratesb
(Ib ai/A)

Crop Type
or Target0



Amount
Handled
per Dayd


PPE Daily
Inhalation
Exposure6
(mg/day)

Short-term
PPE Daily
Inhalation
Dosef
(mg/kg/day)
Int.-term
PPE Daily
Inhalation
Dose8
(mg/kg/day)
PPE Short-
term
Inhalation
MOEh
(mg/day)
Mixer/Loader Risk
Mixing/Loading Wettable Powder for
Aerial/Chemigation Application (2a)

.6
0.5 Ib ai/A
1 Ib ai/A

Ag

350
acres
1.5
3.0
--
0.050
0.021
0.043
--
400
PPE Int. -term
Inhalation
MOE1
(mg/day)


290
140
    Footnotes:
    a
    b
PPE Inhalation Unit Exposure values were calculated with a 5-fold protection factor (80% PF) applied to baseline PHED values. This reflects use of a dust mist respirator.
Application Rates come from values found in the LUIS report and on Iprodione labels. For some scenarios, a range of application rates is used to represent different crops.  For example:
(1)    0.27 Ib ai/A applies to the in furrow spray treatment of cotton during planting [EPA Reg. No. 264-482, 264-453].
(2)    0.5 Ib ai/A applies to almonds, rice (aerial), Chinese mustard and dry bulb onions [EPA Reg. No. 264-482, 264-520].
(3)    1 Ib ai/A applies to stone fruits, potatoes, peanuts, broccoli, lettuce and carrots [EPA Reg. 264-482].
Crop Type or Target provides a general description of the intended uses of various products containing Iprodione. Separate categories are presented because of the distinct differences in application rates and acres treated.
Ag = agricultural crops and Turf =turfgrass including sod-farms, institutional areas and golf courses.  Ornamentals = includes greenhouse, field, landscape, and conifer nurseries.
Amount Handled Per Day values are from the EPA estimates of acreage treated, or volume handled in a single day for each exposure scenario of concern based on the application method.
PPE Daily Inhalation Exposure (mg/day) = Unit Exposure (ug/lb ai) *  (1 mg/1000 ug) Conversion * Application Rate (Ib ai/A or Ib ai/gallon) * Amount Handled Per Day (acres/day or gallons/day).
Short-term PPE Daily Inhalation Dose (mg/kg/day) = PPE Daily Inhalation Exposure (mg/day) / 60 (Body Weight).
Intermediate-term PPE Daily Inhalation Dose (mg/kg/day) = PPE Daily Inhalation Exposure (mg/day) / 70 (Body Weight).
PPE Short-term Inhalation MOE (mg/day) = NOEL (20 mg/kg/day) / Short-term PPE Inhalation Dose (mg/kg/day).
PPE Intermediate-term Inhalation MOE (mg/day) = NOEL (6.1 mg/kg/day) / Intermediate-term PPE Inhalation Dose (mg/kg/day).
                                                                                                        42

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Table 9. Occupational Short-term and Intermediate-term Inhalation Risks from Iprodione with Engineering Controls - Water Soluble-Packets and Enclosed Cab Aerial Application1*
Exposure Scenario (Seen. #)
Range of Application
Rates3
(Ib ai/A)
Crop Type or
Targetb
Amount Handled
per Day0
Engineering Controls'
Inhalation Unit
Exposure
(//g/lb ai)
Short-term Daily
Inhalation Dose6
(mg/kg/day)
Short-term
MOEf
(mg/day)
Int. -term Daily
Inhalation Dose8
(mg/kg/day)
Int. -term MOEh
(mg/day)
Mixer/Loader Risk
Mixing/Loading Wettable Powder for Aerial/Chemigation
Application (2a)
Mixing/Loading Wettable Powder for Groundboom Application
(2b)
Mixing/Loading Wettable Powder for Orchard Airblast Sprayer
Application (2c)
Mixing/Loading Wettable Powder for Professional Application to
Turfgrass using a Low Pressure/ High Volume Handgun (2d)
0.51bai/A
1 Ib ai/A
0.51bai/A
1 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
5. 5 Ib ai/A
Ag
Ag
Ag
ornamentals
turf
350 acres
80 acres
40 acres
5 acres
0.24
0.24
0.24
0.24
0.00070
0.0014
0.00016
0.00032
0.000080
0.00016
0.000028
0.00011
29,000
14,000
130,000
63,000
250,000
130,000
710,000
180,000
0.00060
0.0012
0.00014
0.00027
0.000069
0.00014
0.000024
0.000094
10,000
5,100
44,000
23,000
88,000
44,000
250,000
65,000
Applicator Risk
Applying Sprays with a Fixed-wing Aircraft (5)
Applying Sprays with a Helicopter (6)
0.51bai/A
1 Ib ai/A
0.51bai/A
1 Ib ai/A
Ag
Ag
350 acres
350 acres
0.068
0.0018
0.00020
0.00040
0.0000053
0.000011
100,000
50,000
3,800,000
1,800,000
0.00017
0.00034
0.0000045
0.0000090
36,000
18,000
1,400,000
680,000
     Footnotes:
     a     Application rates come from values found in the LUIS report and on Iprodione labels.  For some scenarios, a range of application rates is used to represent different crops. For example:
           (1)    0.271b ai/A applies to the in furrow spray treatment of cotton during planting [EPA Reg. No. 264-482, 264-453].
           (2)    0.5 Ib ai/A applies to almonds, rice (aerial), Chinese mustard and dry bulb onions [EPA Reg. No. 264-482, 264-520].
           (3)    1 Ib ai/A applies to stone fruits, potatoes, peanuts, broccoli, lettuce and carrots [EPA Reg. 264-482].
     b     Crop Type or Target provides a general description of the intended uses of various products containing Iprodione.  Separate categories are presented because of the distinct differences in application rates and acres treated.
     c     Amount Handled Per Day values are from the EPA estimates of acreage treated, or volume handled in a single day for each exposure scenario of concern based on the application method.
     d     Unit Exposure values are taken from PHED VI. 1
     e     Short-term Daily Inhalation Dose = Inhalation Unit Exposure (ug/lb ai) * Application Rate (Ib ai/A) * Amount Handled per Day (acres/day)/Body Weight (60 kg).
     f     Short-term MOE = NOEL (20 mg/kg/day)/Short-term Daily Inhalation Dose (mg/kg/day).
     g     Intermediate-term Daily Inhalation Dose = Inhalation Unit Exposure (ug/lb ai) * Application Rate (Ib ai/A) * Amount Handled per Day (acres/day)/Body Weight (70 kg).
     h     Intermediate-term MOE = NOEL (6.1 mg/kg/day)/Intermediate-term Daily Inhalation Dose (mg/kg/day).
     I     Engineering Controls = 2a,  2b, 2c water soluble bags; 5,6 enclosed cockpit.
     j      This assessment includes assessments for those scenarios which are currently packaged or applied with engineering controls.
                                                                                                      43

-------
                  d.      Handler Exposure and Risk Estimates for Cancer


           Handler exposure assessments were completed by EPA using a baseline exposure
   scenario and, as needed, increasing levels of risk mitigation (PPE and engineering controls)

   to  achieve  acceptable cancer risks.   Tables  10,  11,  and  12  present total cancer risk

   calculations at baseline, with PPE and with engineering controls,  respectively, for each

   exposure scenario.


           The calculations of daily dermal and inhalation exposure to iprodione by handlers were

   used to calculate the daily dose, and hence the risks, to those handlers. Potential daily dermal

   exposure was calculated using the following formula:



    Daily Dermal Exposure  ——	  = Unit Exposure  ——— x Use Rate  	  x Daily Acres Treated 	
                      (  day }             \ Ib ai)         (  A }                 \ day)



   Potential daily inhalation exposure was calculated using the following formula:
                               Daily Inhalation Exposure  —	
                                                  ^  day )

     TT •„ r^      I MS ai\   r,       ,-,  „  |   Img  \  ,,  „ . I  Ib ai\   _  .,  ,    „   ^ , I  ^4 I
     (7ซ;f Exposure  ^-^	  x Conversion Factor 	a—  x (jse Rate  	  x Daily Acres treated  	
                ( Ib ai}                ( 1,000 /j.g)         (  A )                 ( day)
           The daily dermal and inhalation doses were calculated using a 70 kg body weight
   using the following formulas:
          Daily Inhalation Dose  — — -  = Daily Inhalation Exposure  — — -
                           { kg/day)                       (  day )
day )   { Body Weight (kg)
Daily Dermal Dose  ——	  = Daily Dermal Exposure  ——	  x  	 x 0.05 Dermal Absorption Factor
               \ Kg!Day)                    I Day }   ( Body Weight (Kg))
              Total Daily Dose = Daily Dermal Dose	—  + Daily Inhalation Dose
                                           ( kg/day)
            kg/day
   The lifetime average daily dose (LADD) was calculated using the following formula:




          , ,„„ [  mg \   _ ., „ . ,  _    [  mg  \   [   days worked  \  [35 years worked]
         LADD	—  = Daily Total Dose	— x  	*-	  x 	*-	
              (_ kg/day)                \ kg/day)   \ 365 days per year)  \ 70 year lifetime )
                                           44

-------
Total cancer risk was calculated using the following formula:

                                 Total Cancer Risk = LADD x Ql *

                                  where Qt* = 4.39 E-02

             The following assumptions and factors were used in order to complete this cancer risk
       assessment:

       •      The average body weight of 70 kg is used, representing a typical adult.

       •      Exposure time is assumed to be 8 hours per day. This represents a typical work day.

       •      Exposure duration is assumed to be 35 years.  This represents a typical working
             lifetime.

       •      Lifetime is assumed to be 70 years (USEPA 1997, Exposure Factors Handbook).

       •      Dermal absorption is assumed to be 5 percent, and inhalation absorption is assumed
             to be 100 percent (UISEPA 1997a, USEPA 1998).  The doses were added together
             to represent total daily dose.

       •      The Ql*  used in the cancer assessment was 4.39 x 10"2.

       •      Two  exposure frequencies were used in the calculations, the first represented the
             maximum number of applications per site per season to represent private use, and the
             second frequency applied a factor of 10 to the first frequency to represent commercial
             handlers  making multiple applications per site per season. These are high-end values.
                                           45

-------
Table 10. Occupational Combined Dermal and Inhalation Cancer Risk Assessment for Iprodione at Baseline
Exposure Scenario (Seen. #)
Baseline
Dermal Unit
Exposure"
(mg/lb ai)
Baseline
Inhalation Unit
Exposure1"
(Mg/lb ai)
Range of
Application
Rates'
(Ib ai/A)
Crop Type or
Target11
Amount
Handled
per Day'
Daily Dermal
Exposure1
(mg/day)
Daily
Inhalation
Exposure8
(mg/day)
Baseline Total
Daily Dose
(mg/kg/day)h
Number of
Exposures per
Year'
Baseline LADD"
(mg/kg/day)
Baseline Total
Cancer Riskk
Mixer/Loader Risk
Mixing/Loading Liquids for
Aerial/Chemigation Application (la)
Mixing/Loading Liquids for Groundboom
Application (Ib)
Mixing/Loading Liquid for Orchard
Airblast Sprayer Application (Ic)
Mixing/Loading Liquids for Professional
Application to Turf Using a Low
Pressure/High Volume Handgun (Id)
Mixing/Loading Wettable Powder for
Aerial/Chemigation Application (2a)
Mixing/Loading Wettable Powder for
Groundboomt Application (2b)
Mixing/Loading Wettable Powder for
Orchard Airblast Sprayer Application (2c)
Mixing/Loading Wettable Powder for
Professional Application to Turf using a
Low Pressure/High Volume Handgun (2d)
Mixing/Loading Dry Flowable for
Chemigation Application (3a)
Mixing/Loading Dry Flowable Groundboom
Application (3b)
Loading Granulars for Tractor- Drawn
Spreader Application (4)
2.9
2.9
2.9
2.9
3.7
3.7
3.7
3.7
0.066
0.066
0.0084
1.2
1.2
1.2
1.2
43
43
43
43
0.77
0.77
1.7
0.51bai/A
1 Ib ai/A
5. 5 Ib ai/A
1.41bai/A
0.27 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
4 Ib ai/A
5. 5 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
5. 5 Ib ai/A
0.51bai/A
1 Ib ai/A
0.51bai/A
1 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
5. 5 Ib ai/A
5. 5 Ib ai/A
1 Ib ai/A
5. 5 Ib ai/A
0.68 Ib ai/A
1.41bai/A
4. 1 Ib ai/A
Ag
Turf
Ornamentals
Ag
Ornamentals
Turf
Ag
Ornamentals
Turf
Ag
Ag
Ag
Ornamentals
Turf
Turf
Ornamentals
Turf
Turf
350 acres
100 acres
80 acres
80 acres

40 acres
5 acres
350 acres
80 acres
40 acres
5 acres
350 acres
80 acres
80 acres
80 acres
510
1,000
5,600
410
63
120
230
320
930
1,300
58
120
20
80
650
1,300
150
300
74
150
26
100
130
5.3
29
0.46
0.94
2.8
0.21
0.42
2.3
0.17
0.026
0.048
0.096
0.13
0.38
0.53
0.024
0.048
0.0084
0.033
7.5
15
1.7
3.4
0.86
1.7
0.30
1.2
1.5
0.062
0.34
0.093
0.19
0.56
0.37
0.73
4.0
0.29
0.045
0.084
0.17
0.23
0.67
0.92
0.042
0.084
0.015
0.057
0.57
1.1
0.13
0.26
0.065
0.13
0.023
0.90
0.11
0.0047
0.026
0.0016
0.0034
0.0099
10/100
4/40
6/60
8/80
1/10
10/100
10/100
8/80
8/80
8/80
4/40
4/40
8/80
6/60
10/100
4/40
10/100
5/50
4/40
4/40
8/80
6/60
6/60
8/80
8/80
8/80
8/80
8/80
5.1E-3/5.1E-2
4.0E-3 /4.0E-2
3.3E-2/3.3E-1
3.3E-3/3.3E-2
6.2E-5/6.2E-4
1.2E-3/1.2E-2
2.3E-3/2.3E-2
2.5E-3/2.5E-2
7.3E-3 / 7.3E-2
1.0E-2/1.0E-1
2.3E-4/2.3E-3
4.6E-4 / 4.6E-3
1.6E-4/1.6E-3
4.8E-4/4.8E-3
7.8E-3/7.8E-2
6.0E-3 / 6.0E-2
1.8E-3/1.8E-2
1.8E-3/1.8E-2
3.6E-4/3.6E-3
7.1E-4/7.1E-3
2.5E-4/2.5E-3
7.4 E-4 / 7.4 E-3
9.0E-4 / 9.0E-3
5.2E-5 /5.2E-4
2.9E-4 / 2.9E-3
1.8E-5/1.8E-4
3.7E-5/3.7E-4
1.1E-4/1.1E-3
2.2E-4 / 2.2E-3
1.8E-4/1.8E-3
1.4E-3/1.4E-2
1.4E-4/1.4E-3
2.7E-6 / 2.7E-5
5.3E-5/5.3E-4
1.0E-4/1.0E-3
1.1E-4/1.1E-3
3.2E-4/3.2E-3
4.4E-4 / 4.4E-3
1.0E-5/1.0E-4
2.0E-5/2.0E-4
7.0E-6 / 7.0E-5
2.1E-5/2.1E-4
3.4E-4/3.4E-3
2.6E-4 / 2.6E-3
7.9E-5 / 7.9E-4
7.9E-5 / 7.-9E4
1.6E-5/1.6E-4
3.1E-5/3.1E-4
1.1E-5/1.1E-4
3.2 E-5/ 3.2 E-4
4.0E-5 / 4.0 E-4
2.3E-6/2.3E-5
1.3E-5/1.3E-4
7.9E-7 / 7.9E-6
1.6E-6/1.6E-5
4.8E-6/4.8E-5
Applicator Risk
Applying Sprays with a Fixed- Wing
Aircraft (5)
Applying Sprays with a Helicopter (6)
No Data
See EC
No Data
See EC
No Data
See EC
No Data
See EC
0.51bai/A
1 Ib ai/A
0.51bai/A
1 Ib ai/A
Ag
Ag
350 acres
350 acres
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
See Eng. Con.
                                                                          46

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Exposure Scenario (Seen. #)
Applying Sprays with a Groundboom
Sprayer (7)
Applying to Orchards with an Airblast
Sprayer (8)
Applying with a Low Pressure/High
Volume Handgun to Turfgrass (9)1
Applying Granulars with a Tractor-Drawn
Spreader (10)
Baseline
Dermal Unit
Exposure"
(mg/lb ai)
014
0.36
No Data
(See PPE)
0.0099
Baseline
Inhalation Unit
Exposure1"
(Mg/lb ai)
0.74
4.5
1.4
1.2
Range of
Application
Rates'
(Ib ai/A)
0.27 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
4 Ib ai/A
5. 5 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
5. 5 Ib ai/A
0.68 Ib ai/A
1.41bai/A
4. lib ai/A
Crop Type or
Target11
Ag
Ornamentals
Turf
Ag
Ornamentals
Turf
Turf
Amount
Handled
per Day'
80 acres
80 acres
80 acres
40 acres
5 acres
80 acres
Daily Dermal
Exposure1
(mg/day)
0.30
0.56
1.1
1.6
4.5
6.2
7.2
14
NA
NA
0.54
1.1
3.2
Daily
Inhalation
Exposure8
(mg/day)
0.016
0.030
0.059
0.083
0.24
0.33
0.090
0.18
0.098
0.038
0.065
0.13
0.39
Baseline Total
Daily Dose
(mg/kg/day)h
4.4E-4
8.2E-4
0.0016
0.0023
0.0066
0.0091
0.0064
0.013
NA
NA
0.0013
0.0027
0.0079
Number of
Exposures per
Year'
1/10
10/100
10/100
8/80
8/80
8/80
4/40
4/40
8/80
8/80
8/80
8/80
8/80
Baseline LADD"
(mg/kg/day)
6.0E-7 / 6.0E-6
1.1E-5/1.1E-4
2.2E-5/2.2E-4
2.5E-5/2.5E-4
7.2E-5 / 7.2E-4
1.0E-4/1.0E-3
3.5E-5/3.5E-4
7.1E-5/7.1E-4
NA
NA
1.4E-5/1.4E-4
3.0E-5/3.0E-4
8.7E-5 / 8.7E-4
Baseline Total
Cancer Riskk
2.6E-8/2.6E-7
4.8E-7/4.8E-6
9.7E-7 / 9.7E-6
1.1E-6/1.1E-5
3.2E-6/3.2E-5
4.4E-6 / 4.4E-5
1.5E-6/1.5E-5
3.1E-6/3.1E-5
NA
NA
6.1E-7/6.1E-6
1.3E-6/1.3E-5
3.8E-6/3.8E-5
Mixer/Loader/Applicator Exposure
Mixing/Loading/Applying Sprays with a
Low Pressure Handwand (11)
Mixing/Loading/Applying Sprays with a
High Pressure Handwand (12)
Mixing/Loading/Applying Using a
Backpack Sprayer (13)
Loading/ Applying Granulars Using a
Belly Grinder (14)
Loading/ Applying Using a Push- Type
Granular Spreader (15)
100
3.5
No Data
See PPE
10
2.9
30
120
30
62
6.3
0.002 Ib ai/gal
0.01 Ib ai/gal
5. 5 Ib ai/A
0.51bai/A
1 Ib ai/A
0.002 Ib ai/gal
0.01 Ib ai/gal
0.002 Ib ai/gal
0.01 Ib ai/gal
5. 5 Ib ai/A
0.68 Ib ai/A
1.41bai/A
4. lib ai/A
0.68 Ib ai/A
1.41bai/A
4. 1 Ib ai/A
Turf&
Ornamentals
Turf
Ag
Ornamentals
Turf&
Ornamentals
Turf
Turf
Turf
40 gallons
5 acres
5 acres
1,000
gallons
40 gallons
5 acres
5 acres
5 acres
8.0
40
2,800
8.8
18
7.0
35
See PPE
See PPE
34
70
210
9.9
20
59
0.0024
0.012
0.83
0.30
0.60
0.24
1.2
0.0024
0.012
See PPE
0.21
0.43
1.3
0.021
0.044
0.13
0.0057
0.029
2.0
0.011
0.021
0.0084
0.042
See PPE
See PPE
0.027
0.056
0.16
0.0073
0.015
0.044
8/80
8/80
8/80
10/100
10/100
8/ 80
8/ 80
8/ 80
8/ 80
8/ 80
8/ 80
8/ 80
8/ 80
8/80
8/80
8/80
6.3E-5/6.3E-4
3.2E-4/3.2E-3
2.2E-2/2.2E-1
1.5E-4/1.5E-3
2.9E-4 / 2.9E-3
9.2E-5/9.2E-4
4.6E-4 / 4.6E-3
See PPE
See PPE
3.0E-4/3.0E-3
6.1E-4/6.1E-3
1.8E-3/1.8E-2
8.0E-5 / 8.0E-4
1.6E-4/1.6E-5
4.8E-4/4.8E-3
2.8E-6/2.8E-5
1.4E-5/1.4E-4
9.7E-4 / 9.7E-3
6.6E-6/6.6E-5
1.3E-5/1.3E-4
4.0E-6 / 4.0E-5
2.0E-5/2.0E-4
See PPE
See PPE
1.3E-5/1.3E-4
2.7E-5 / 2.7E-4
7.9E-5 / 7.9E-4
3.5E-6/3.5E-5
7.2E-6 / 7.2E-5
2..1E-5/2.1E-4
Flagger Risk
Flagging Spray Applications (19)
0.011
0.35
0.51bai/A
1 Ib ai/A
Ag
350 acres
1.8
3.5
0.061
0.12
0.0021
0.0042
10/100
4/40
2.9E-5/2.9E-4
2.3E-5/2.3E-4
1.3E-6/1.3E-5
1.0E-6/1.0E-5
Footnotes:
a     Baseline Dermal Unit Exposure represents long pants, long sleeved shirt, no gloves, open mixing/loading, and open cab tractors as appropriate.
b     Baseline Inhalation Unit Exposure reflects no respiratory protection.
c     Application rates come from values found in the LUIS report and on Iprodione labels. For some scenarios, a range of application rates is used to represent different crops. For example:
      (1)    0.27 Ib ai/A applies to the in furrow spray treatment of cotton during planting [EPA Reg. No. 264-482, 264-453].
                                                                                                       47

-------
      (2)    0.5 Ib ai/A applies to almonds, rice (aerial), Chinese mustard and dry bulb onions [EPA Reg. No. 264-482, 264-520].
      (3)    1 Ib ai/A applies to stone fruits, potatoes, peanuts, broccoli, lettuce and carrots [EPA Reg. 264-482].
d     Crop Type or Target provides a general description of the intended uses of various products containing Iprodione. Separate categories are presented because of the distinct differences in application rates and acres treated.
      Ag = agricultural crops and Turf =turfgrass including sod-farms, institutional areas and golf courses.  Ornamentals = includes greenhouse, field, landscape, and conifer nurseries.
e     Amount Handled Per Day values are from the EPA estimates of acreage treated, or volume handled in a single day for each exposure scenario of concern based on the application method.
f     Daily Dermal Exposure (mg/day) = Unit Exposure (mg/lb ai) * Application Rate (Ib ai/A or Ib ai/gallon) * Amount Handled Per Day (acres/day or gallons/day).
g     Daily Inhalation Exposure (mg/day) = Unit Exposure (ug/lb ai) * (1 mg/1000 ug) Conversion * Application Rate (Ib ai/A or Ib ai/gallon) * Amount Handled Per Day (acres/day or gallons/day).
h     Baseline Total Daily Dose = [Baseline Daily Dermal Exposure (mg/day) * 0.05 (Dermal Absorption Factor) + Baseline Daily Inhalation Exposure (mg/day)]/Body Weight (70 kg).
I     Number of Exposures Per Year is based on maximum number of applications which represent private use. A factor of 10 was used to estimate commercial use.
j     Baseline LADD (mg/kg/day) = Baseline Total Daily Dose (mg/kg/day) * (Number of days exposure per year /365 days per year) * 35 years worked/70 year lifetime.
k     Baseline Total Cancer Risk = Baseline LADD (mg/kg/day) * (Qj*), where Q/ = 4.39E-2 (mg/kg/day).
1     Baseline dermal data not available. See PPE for dermal and combined exposures, doses, and risks.
 Table 11.  Occupational Combined Dermal and Inhalation Cancer Risk Assessment for Iprodione with PPE
Exposure Scenario (Seen. #)
PPE Dermal
Unit
Exposure"
(mg/lb ai)
PPE Inhalation
Unit Exposure1"
(Mg/lb ai)
Range of
Application
Rates'
(Ib ai/A)
Crop Type
or Target1"
Amount
Handled per
Daye
PPE Daily
Dermal
Exposure1
(mg/day)
PPE Daily
Inhalation
Exposure8
(mg/day)
PPE Total Daily
Dose
(mg/kg/day)h
Number of
Exposures per
Year1
PPE LADD"
(mg/kg/day)
PPE Total
Cancer Riskk
Mixer/Loader Risk
Mixing/Loading Liquids for
Aerial/Chemigation Application (la)
Mixing/Loading Liquids for Groundboom
Application (Ib)
Mixing/Loading Liquid for Orchard
Airblast Sprayer Application (Ic)
Mixing/Loading Liquids for Professional
Application to Turf Using a Low
Pressure/High Volume Handgun (Id)
Mixing/Loading Wettable Powder for
Aerial/Chemigation Application (2a)
Mixing/Loading Wettable Powder for
Groundboom Application (2b)
Mixing/Loading Wettable Powder for
Orchard Airblast Sprayer Application (2c)
Mixing/Loading Wettable Powder for
Professional Application to Turf using a
Low Pressure/High Volume Handgun (2d)
Mixing/Loading Dry Flowable for
Chemigation Application (3a)
Mixing/Loading Dry Flowable
Groundboom Application (3b)
0.017
0.023
0.023
0.023
0.13
0.13
0.17
0.17
0.047
0.047
1.2
1.2
1.2
1.2
8.6
8.6
43
43
0.15
0.77
0.51bai/A
1 Ib ai/A
5. 5 Ib ai/A
1.41bai/A
0.27 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
4 Ib ai/A
5. 5 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
5. 5 Ib ai/A
0.51bai/A
1 Ib ai/A
0.51bai/A
1 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
5. 5 Ib ai/A
5. 5 Ib ai/A
1 Ib ai/A
5. 5 Ib ai/A
Ag
Turf
Ornamentals
Ag
Ornamentals
Turf
Ag
Ornamentals
Turf
Ag
Ag
Ag
Ornamentals
turf
Turf
Ornamentals
Turf
350 acres
100 acres
80 acres
80 acres

40 acres
5 acres
350 acres
80 acres
40 acres
5 acres
350 acres
80 acres
80 acres
3.0
6.0
33
2.4
0.50
0.92
1.8
2.6
7.4
10
0.46
0.92
0.16
0.63
23
46
5.2
10
3.4
6.8
1.2
4.7
90
3.8
21
0.21
0.42
2.3
0.17
0.026
0.048
0.096
0.13
0.38
0.53
0.024
0.048
0.0084
0.033
1.5
3.0
0.34
0.69
0.86
1.7
0.30
1.2
0.29
0.062
0.34
0.0051
0.010
0.056
0.0041
0.00073
0.0013
0.0027
0.0038
0.011
0.015
0.00067
0.0013
0.00024
0.00094
0.038
0.076
0.0086
0.017
0.015
0.029
0.0052
0.020
0.068
0.0036
0.020
10/100
4/40
6/60
8/80
1/10
10/100
10/100
8/80
8/80
8/80
4/40
4/40
8/80
6/60
10/100
4/40
10/100
5/50
4/40
4/40
8/80
6/60
6/60
8/80
8/80
7.0E-5 / 7.0E-4
5.6E-5 / 5.6E-4
4.6E-4 / 4.6E-3
4.5E-5/4.5E-4
9.9E-7 / 9.9E-6
1.8E-5/ 1.8E-4
3.7E-5/3.7E-4
4.1E-5/4.1E-4
1.2E-4/1.2E-3
1.6E-4/1.6E-3
3.7E-6/3.7E-5
7.4E-6 / 7.4E-5
2.6E-6/2.6E-5
7.6E-6 / 7.6E-5
5.2E-4/5.2E-3
4.2E-4 / 4.2E-3
1.2E-4/1.2E-3
1.2E-4/1.2E-3
8.1E-5/8.1E-4
1.6E-4/1.6E-3
5.6E-5/5.6E-4
1.7E-4/1.7E-3
5.6E-4/5.6E-3
3.9E-5/ 3.9-4
2.1E-4/2.1E-3
3.1E-6/3.1E-5
2.5E-6/2.5E-5
2.0E-5/2.0E-4
2.0E-6/2.0E-5
4.4E-8 / 4.4E-7
8.1E-7/8.1E-6
1.6E-6/1.6E-5
1.8E-6/1.8E-5
5.2E-6 / 5.2E-5
7.1E-6/7.1E-5
1.6E-7/1.6E-6
3.2E-7/3.2E-6
1.1E-7/1.1E-6
3.3E-7/3.3E-6
2.3E-5/2.3E-4
1.8E-5/1.8E-4
5.3E-6/5.3E-5
5.3E-6/5.3E-5
3.5E-6/3.5E-5
7.1E-6/7.1E-5
2.5E-6/2.5E-5
7.3E-6/7.3E-5
2.5E-5/2.5E-4
1.7E-6/1.7E-5
9.4E-6 / 9.4E-5
                                                                                                       48

-------
Exposure Scenario (Seen. #)
Loading Granulars for Tractor- Drawn
Spreader Application (4)
PPE Dermal
Unit
Exposure"
(mg/lb ai)
0.0084
PPE Inhalation
Unit Exposure1"
(Mg/lb ai)
1.7
Range of
Application
Rates'
(Ib ai/A)
0.68 Ib ai/A
1.41bai/A
4. 1 Ib ai/A
Crop Type
or Target1"
Turf
Amount
Handled per
Daye
80 acres
PPE Daily
Dermal
Exposure1
(mg/day)
0.46
0.94
2.8
PPE Daily
Inhalation
Exposure8
(mg/day)
0.093
0.19
0.56
PPE Total Daily
Dose
(mg/kg/day)h
0.0016
0.0034
0.0099
Number of
Exposures per
Year1
8/80
8/80
8/80
PPE LADD"
(mg/kg/day)
1.8E-5/1.8E-4
3.7E-5/3.7E-4
1.1E-4/1.1E-3
PPE Total
Cancer Riskk
7.9E-7 / 7.9E-6
1.6E-6/1.6E-5
4.8E-6/4.8E-5
Applicator Risk
Applying Sprays with a Fixed- Wing
Aircraft (5)
Applying Sprays with a Helicopter (6)
Applying Sprays with a Groundboom
Sprayer (7)
Applying to Orchards with an Airblast
Sprayer (8)
Applying with a Low Pressure/High
Volume Handgun to Turfgrass (9)
Applying Granulars with a Tractor-Drawn
Spreader (10)
No Data
SeeEng. Con.
No Data
See Eng. Con.
0.014
0.36
0.34
0.0099
No Data
SeeEng. Con.
No Data
See Eng. Con.
0.74
4.5
1.4
1.2
0.51bai/A
1 Ib ai/A
0.51bai/A
1 Ib ai/A
0.27 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
4 Ib ai/A
5. 5 Ib ai/A
0.51bai/A
1 Ib ai/A
1.41bai/A
5. 5 Ib ai/A
0.68 Ib ai/A
1.41bai/A
4. 1 Ib ai/A
Ag
Ag
Ag
Ornamentals
Turf
Ag
Ornamentals
Turf
Turf
350 acres
350 acres
80 acres
80 acres
80 acres
40 acres
5 acres
80 acres
SeeEng. Con.
See Eng. Con.
0.30
0.56
1.1
1.6
4.5
6.2
7.2
14
2.4
9.4
0.54
1.1
3.2
SeeEng. Con.
See Eng. Con.
0.016
0.030
0.059
0.083
0.24
0.33
0.090
0.18
0.0098
0.039
0.065
0.13
0.39
SeeEng. Con.
See Eng. Con.
4.4E-4
8.2E-4
0.0016
0.0023
0.0066
0.0091
0.0064
0.013
0.0018
0.0072
0.0013
0.0027
0.0079
See Eng. Con.
See Eng. Con.
1/10
10/100
10/100
8/80
8/80
8/80
4/40
4/40
8/80
8/80
8/80
8/80
8/80
See Eng. Con.
See Eng. Con.
6.0E-7 / 6.0E-6
1.1E-5/1.1E-4
2.2E-5/2.2E-4
2.5E-5/2.5E-4
7.2E-5 / 7.2E-4
1.0E-4/1.0E-3
3.5E-5/3.5E-4
7.1E-5/7.1E-4
2.0E-5/2.0E-4
7.9E-5 / 7.9E-4
1.4E-5/1.4E-4
3.0E-5/3.0E-4
8.7E-5 / 8.7E-4
SeeEng. Con.
See Eng. Con.
2.6E-8/2.6E-7
4.8E-7/4.8E-6
9.7E-7 / 9.7E-6
1.1E-6/1.1E-5
3.2E-6/3.2E-5
4.4E-6 / 4.4E-5
1.5E-6/1.5E-5
3.1E-6/3.1E-5
8.9E-7 / 8.9E-6
3.5E-6/3.5E-5
6.1E-7/6.1E-6
1.3E-6/1.3E-5
3.8E-6/3.8E-5
Mixer/Loader/Applicator Risk
Mixing/Loading/Applying Sprays with a
Low Pressure Handwand (11)
Mixing/Loading/Applying Sprays with a
High Pressure Handwand (12)
Mixing/Loading/Applying Using a
Backpack Sprayer (13)
Loading/ Applying Granulars Using a Belly
Grinder (14)
0.43
1.6
1.6
9.3
30
24
6
12
0.002 Ib
ai/gal
0.01 Ib ai/gal
5. 5 Ib ai/A
0.51bai/A
1 Ib ai/A
0.002 Ib
ai/gal
0.01 Ib ai/gal
0.002 Ib
ai/gal
0.01 Ib ai/gal
5. 5 Ib ai/A
0.68 Ib ai/A
1.41bai/A
4. 1 Ib ai/A
Turf&
Ornamentals
Turf
Ag
Ornamentals
Turf&
Ornamentals
Turf
Turf
40 gallons
5 acres
5 acres
1,000
gallons
40 gallons
5 acres
5 acres
0.034
0.17
12
4.0
8.0
3.2
16
0.13
0.64
44
28
57
170
0.0024
0.012
0.83
0.060
0.12
0.048
0.24
0.00048
0.0024
0.17
0.041
0.084
0.25
5.9E-5
2.9E-4
0.020
0.0037
0.0074
0.0030
0.015
0.00010
0.00049
0.034
0.021
0.042
0.12
8/80
8/80
8/80
10/100
10/100
8/ 80
8/ 80
8/ 80
8/ 80
8/ 80
8/ 80
8/ 80
8/ 80
6.5E-7/6.5E-6
3.2E-6/3.2E-5
2.2E-4 / 2.2E-3
5.1E-5/5.1E-4
1.0E-4/1.0E-3
3.3E-5/3.3E-4
1.6E-4/1.6E-3
1.1E-6/1.1E-5
5.4E-6 / 5.4E-5
3.7E-4/3.7E-3
2.2E-4 / 2.2E-3
4.6E-4 / 4.6E-3
1.4E-3/1.4E-2
2.8E-8/2.8E-7
1.4E-8/1.4E-7
9.7E-6 / 9.7E-5
2.2E-6/2.2E-5
4.4E-6 / 4.4E-5
1.4E-6/1.4E-5
7.0E-6 / 7.0E-5
4.8E-8/4.8E-7
2.4E-7 / 2.4E-6
1.6E-5/1.6E-4
9.9E-6/9.9E-5
2.0E-5/2.0E-4
5.9E-5 / 5.9E-4
49

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Exposure Scenario (Seen. #)
Loading/ Applying Using a Push- Type
Granular Spreader (15)
Mixing/Loading/Applying as a Seed Soak
Treatment (16)
Mixing/Loading/Applying as a Commercial
Seed Treatment in Slurry Form (17)
Mixing/Loading/Applying Solution as a
Dip Treatment (18)
PPE Dermal
Unit
Exposure"
(mg/lb ai)
1.3
No Data
No Data
No Data
PPE Inhalation
Unit Exposure1"
(Mg/lb ai)
6.3
No Data
No Data
No Data
Range of
Application
Rates'
(Ib ai/A)
0.68 Ib ai/A
1.41bai/A
4. 1 Ib ai/A
No Data
No Data
No Data
Crop Type
or Target1"
Turf
No Data
No Data
No Data
Amount
Handled per
Daye
5 acres
No Data
No Data
No Data
PPE Daily
Dermal
Exposure1
(mg/day)
4.4
9.1
27
No Data
No Data
No Data
PPE Daily
Inhalation
Exposure8
(mg/day)
0.021
0.044
0.13
No Data
No Data
No Data
PPE Total Daily
Dose
(mg/kg/day)h
0.0035
0.0071
0.021
No Data
No Data
No Data
Number of
Exposures per
Year1
8/80
8/80
8/80
No Data
No Data
No Data
PPE LADD>
(mg/kg/day)
3.8E-5/3.8E-4
7.8E-5/7.8E-4
2.3E-4/2.3E-3
No Data
No Data
No Data
PPE Total
Cancer Riskk
1.7E-6/1.7E-5
3.4E-6/3.4E-5
1.0E-5/1.0E-4
No Data
No Data
No Data
Flagger Risk
Flagging Spray Applications (19)
0.011
0.35
0.51bai/A
1 Ib ai/A
Ag
350 acres
1.8
3.5
0.061
0.12
0.0021
0.0042
10/100
4/40
2.9E-5/2.9E-4
2.3E-5/2.3E-4
1.3E-6/1.3E-5
1.0E-6/1.0E-5
Footnotes:
a     PPE Dermal Unit Exposure represents:
                     - double layer of clothes and chemical resistant gloves for scenarios la, 2a, 2b, 3a, 3b, 12, 13, and 14.
                     - chemical resistant gloves for scenarios Ib, Ic, Id, 2c, 2d, 9, 11, and 15.
b     PPE Inhalation Unit Exposure reflects use of dust/mist respirator (5-fold PF) for scenarios 2a, 2b, 3a,  12, 13, and 14.
c     Application rates come from values found in the LUIS report and on Iprodione labels.  See Table 7 for particular examples.
d     Crop Type or Target provides a general description of the intended uses of various products containing Iprodione. Separate categories are presented because of the distinct differences in application rates and acres treated.
      Ag = agricultural crops and Turf =turfgrass including sod-farms, institutional areas and golf courses. Ornamentals = includes greenhouse, field, landscape, and conifer nurseries.
e     Amount Handled Per Day values are from the EPA estimates of acreage treated, or volume handled in a single day for each exposure scenario of concern based on the application method.
f     PPE Daily Dermal Exposure (mg/day) = PPE Unit Exposure (mg/lb ai) * Application Rate (Ib ai/A or Ib ai/gallon) * Amount Handled Per Day (acres/day or gallons/day).
g     PPE Daily Inhalation Exposure (mg/day) = PPE Unit Exposure (ug/lb ai) * (1 mg/1000 ug) Conversion * Application Rate (Ib ai/A or Ib ai/gallon) * Amount Handled Per Day (acres/day or gallons/day).
h     PPE Total Daily Dose =  [PPE Daily Dermal Exposure (mg/day) *  0.05 (Dermal Absorption Factor) + PPE Daily Inhalation Exposure (mg/day)]/Body Weight (70 kg).
I     Number of Exposures Per Year is based on maximum number of applications which represent private use. A factor of 10 was used to estimate commercial use.
j     PPE LADD (mg/kg/day) = PPE Total Daily Dose (mg/kg/day) * (Number of days exposure per year /365 days per year) * 3 5 years worked/70 year lifetime.
k     PPE Total Cancer Risk = PPE LADD (mg/kg/day) * (Qj*), where Q/ = 4.39E-2 (mg/kg/day).
                                                                                                        50

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Table 12. Occupational Combined Dermal and Inhalation Cancer Risk Assessment for Iprodione with Engineering Controls
Exposure Scenario (Seen. #)
Eng. Cont.
Dermal Unit
Exposure3
(mg/lb ai)
Eng. Cont.
Inhalation
Unit
Exposure11
(Mg/lb ai)
Range of
Application
Rates0
(Ib ai/A)
Crop Type or
Target4
Amount
Handled
per Day6
Eng. Con.
Daily
Dermal
Exposure5
(mg/day)
Eng. Con.
Daily
Inhalation
Exposure8
(mg/day)
Eng. Cont.
Total Daily
Dose
(mg/kg/day)11
Number of
Exposures per
Year1
Eng. Cont.
LADD
(mg/kg/day)
Eng. Cont.
Total Cancer
Riskk
Mixer/Loader Risk
Mixing/Loading Liquids for
Aerial/Chemigation Application
(la)
Mixing/Loading Liquids for
Groundboom Application (Ib)
Mixing/Loading Liquid for
Orchard Airblast Sprayer
Application (Ic)
Mixing/Loading Liquids for
Professional Application to Turf
Using a Low Pressure/High
Volume Handgun (Id)
Mixing/Loading Wettable Powder
for Aerial/Chemigation Application
(2a)
Mixing/Loading Wettable Powder
for Groundboomt Application (2b)
Mixing/Loading Wettable Powder
for Orchard Airblast Sprayer
Application (2c)
Mixing/Loading Wettable Powder
for Professional Application with
Low Pressure/High Volume
Handgun (2d)
Mixing/Loading Dry Flowable for
Chemigation Application (3a)
Mixing/Loading Dry Flowable
Groundboom Application (3b)
0.0086
0.0086
0.0086
0.0086
0.021
0.021
0.021
0.021
0.021
0.021
0.083
0.083
0.083
0.083
0.24
0.24
0.24
0.24
0.24
0.24
0.5 Ib ai/A
1 Ib ai/A
5.5 Ib ai/A
1.41bai/A
0.27 Ib ai/A
0.5 Ib ai/A
1 Ib ai/A
1.41bai/A
4 Ib ai/A
5.5 Ib ai/A
0.5 Ib ai/A
1 Ib ai/A
1.41bai/A
5.5 Ib ai/A
0.5 Ib ai/A
1 Ib ai/A
0.5 Ib ai/A
1 Ib ai/A
0.5 Ib ai/A
1 Ib ai/A
1.41bai/A
5.5 Ib ai/A
5.5 Ib ai/A
1 Ib ai/A
5.5 Ib ai/A
Ag
Turf
Ornamentals
Ag
Ornamentals
Turf
Ag
Ornamentals
Turf
Ag
Ag
Ag
Ornamentals
Turf
Turf
Ornamentals
Turf
350 acres
100 acres
80 acres
80 acres

40 acres
5 acres
350 acres
80 acres
40 acres
5 acres
350 acres
80 acres
80 acres
1.5
3
17
1.2
0.19
0.34
0.69
0.96
2.8
3.8
0.17
0.34
0.060
0.24
3.7
7.4
0.84
1.7
0.42
0.84
0.15
0.58
40
1.7
9.2
0.015
0.029
0.16
0.012
0.0018
0.0033
0.0066
0.0093
0.027
0.037
0.0017
0.0033
0.00058
0.0023
0.042
0.084
0.0096
0.019
0.0048
0.0096
0.0017
0.0066
0.46
0.019
0.11
0.0013
0.0026
0.014
0.0010
0.00016
0.00029
0.00059
0.00082
0.0024
0.0032
0.00015
0.00029
0.000051
0.00020
0.0032
0.0065
0.00074
0.0015
0.00037
0.00074
0.00013
0.00051
0.035
0.0015
0.0081
10/100
4/40
6/60
8/80
1/10
10/100
10/100
8/80
8/80
8/80
4/40
4/40
8/80
6/60
10/100
4/40
10/100
5/50
4/40
4/40
8/80
6/60
6/60
8/80
8/80
1.8E-5/1.8E-4
1.4E-5/1.4E-4
1.2E-4/1.2E-3
1.1E-5/1.1E-4
2.2E-7/1.1E-6
4.0E-6 / 4.0E-5
8.1E-6/8.1E-5
9.0E-6 / 9.0E-5
2.6E-5 / 2.6E-4
3.5E-5 / 3.5E-4
8.2E-7 / 8.2E-6
1.6E-6/1.6E-5
5.6E-7/5.6E-6
1.6E-6/1.6E-5
4.4E-5 / 4.4E-4
3.5E-5 / 3.5E-4
1.0E-5/1.0E-4
1.0E-5/1.0E-4
2.0E-6 / 2.0E-5
4.0E-6 / 4.0E-5
1.4E-6/1.4E-5
4.2E -6 / 4.2E-
5
2.9E-4/2.9E-3
1.6E-5/1.6E-4
8.9E-5 / 8.9E-4
7.9E-7 / 7.9E-6
6.1E-7/6.1E-6
5.3E-6 / 5.3E-5
4.8E-7/4.8E-6
9.7E-9 / 9.7E-8
1.8E-7/1.8E-6
3.6E-7/3.6E-6
4.0E-7 / 4.0E-6
1.1E-6/1.1E-5
1.5E-6/1.5E-5
3.6E-8 / 3.6E-7
7.0E-8 / 7.0E-7
2.5E-8/2.5E-7
7.0E-8 / 7.0E-7
1.9E-6/1.9E-5
1.6E-6/1.6E-5
4.4E-7 / 4.4E-6
4.4E-7 / 4.4E-6
8.9E-8 / 8.9E-7
1.8E-7/1.8E-6
6.2E-8 / 6.2E-7
1.8E-7/1.8E-6
1.3E-5/1.3E-4
7.1E-7/7.1E-6
3.9E-6 / 3.9E-5
                                                                       51

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Table 12. Occupational Combined Dermal and Inhalation Cancer Risk Assessment for Iprodione with Engineering Controls (Continued)
Exposure Scenario (Seen. #)
Loading Granulars for
Tractor-Drawn Spreader
Application (4)
Eng. Cont.
Dermal Unit
Exposure3
(mg/lb ai)
0.00017
Eng. Cont.
Inhalation
Unit
Exposure11
(Mg/lb ai)
0.034
Range of
Application
Rates0
(Ib ai/A)
0.68 Ib ai/A
1.41bai/A
4. lib ai/A
Crop Type or
Target4
Turf
Amount
Handled
per Day6
80 acres
Eng. Con.
Daily
Dermal
Exposure5
(mg/day)
0.0092
0.019
0.056
Eng. Con.
Daily
Inhalation
Exposure8
(mg/day)
0.0018
0.0038
0.011
Eng. Cont.
Total Daily
Dose
(mg/kg/day)11
0.000032
0.000068
0.00020
Number of
Exposures per
Year1
8/80
8/80
8/80
Eng. Cont.
LADD
(mg/kg/day)
3.5E-7/3.5E-6
7.5E-7 / 7.5E-6
2.2E-6 / 2.2E-5
Eng. Cont.
Total Cancer
Riskk
1.5E-8/1.5E-7
3.3E-8 / 3.3E-7
9.7E-8 / 9.7E-7
Applicator Risk
Applying Sprays with a
Fixed- Wing Aircraft (5)
Applying Sprays with a Helicopter
(6)
Applying Sprays with a
Groundboom Sprayer (7)
Applying to Orchards with an
Airblast Sprayer (8)
Applying with a Low
Pressure/High Volume Handgun to
Turfgrass (9)
Applying Granulars with a
Tractor-Drawn Spreader (10)
0.0050
0.0019
0.005
0.019
NA
0.0021
0.068
0.0018
0.043
0.45
NA
0.22
0.5 Ib ai/A
1 Ib ai/A
0.5 Ib ai/A
1 Ib ai/A
0.27 Ib ai/A
0.5 Ib ai/A
1 Ib ai/A
1.41bai/A
4 Ib ai/A
5.5 Ib ai/A
0.5 Ib ai/A
1 Ib ai/A
1.41bai/A
5.5 Ib ai/A
0.68 Ib ai/A
1.41bai/A
4. lib ai/A
Ag
Ag
Ag
Ornamentals
Turf
Ag
Ornamentals
Turf
Turf
350 acres
350 acres
80 acres
80 acres
80 acres
40 acres
5 acres
80 acres
0.88
1.8
0.33
0.67
0.11
0.20
0.40
0.56
1.6
2.2
0.38
0.76
NA
NA
0.11
0.24
0.69
0.012
0.024
0.00032
0.00063
0.00093
0.0017
0.0034
0.0048
0.014
0.019
0.0090
0.018
NA
NA
0.012
0.025
0.072
0.00080
0.0016
0.00024
0.00049
0.000092
0.00017
0.00033
0.00047
0.0013
0.0018
0.00040
0.00080
NA
NA
0.00025
0.00053
0.0015
10/100
4/40
10/100
4/40
1/10
10/100
10/100
8/80
8/80
8/80
4/40
4/40
8/80
8/ 80
8/80
8/80
8/80
1.1E-5/1.1E-4
8.8E-6 / 8.8E-5
3.3E-6 / 3.3E-5
2.7E-6 / 2.7E-5
1.3E-7/1.3E-6
2.3E-6/2.3E-5
4.5E-6/4.5E-5
5.2E-6 / 5.2E-5
1.4E-5/1.4E-4
2.0E-5 / 2.0E-4
2.2E-6 / 2.2E-5
4.4E-6 / 4.4E-5
NA
NA
2.7E-6 / 2.7E-5
5.8E-6 / 5.8E-5
1.6E-5/1.6E-4
4.8E-7/4.8E-6
3.9E-7/3.9E-6
1.4E-7/1.4E-6
1.2E-7/1.2E-6
5.7E-9 / 5.7E-8
1.0E-7/1.0E-6
2.0E-7 / 2.0E-6
2.3E-7/2.3E-6
6.1E-7/6.1E-6
8.8E-7 / 8.8E-6
9.6E-8 / 9.6E-7
1.9E-7/1.9E-6
NA
NA
1.2E-7/1.2E-6
2.5E-7/2.5E-6
7.0E-7 / 7.0E-6
Mixer/Loader/Applicator Exposure
Mixing/Loading/Applying Sprays
with a Low Pressure Handwand
(11)
Mixing/Loading/Applying Sprays
with a High Pressure Handwand
(12)
NA
NA
NA
NA
0.002 Ib
ai/gal
0.01 Ib ai/gal
5.5 Ib ai/A
0.5 Ib ai/A
1 Ib ai/A
0.002 Ib
ai/gal
0.01 Ib ai/gal
Turf&
Ornamentals
Turf
Ag
Ornamentals
40 gallons
5 acres
5 acres
1,000
gallons
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
8/80
8/80
8/80
10/100
10/100
8/ 80
8/ 80
NA
NA
NA
NA
NA
NA
NA
NA
                                                              52

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          Table 12.  Occupational Combined Dermal and Inhalation Cancer Risk Assessment for Iprodione with Engineering Controls (Continued)
Exposure Scenario (Seen. #)
Mixing/Loading/Applying Using a
Backpack Sprayer (13)
Loading/Applying Granulars Using
a Belly Grinder (14)
Loading/Applying Using a
Push- Type Granular Spreader (15)
Mixing/Loading/Applying as a
Seed Soak Treatment (16)
Mixing/Loading/Applying as a
Commercial Seed Treatment in
Slurry Form (17)
Mixing/Loading/Applying Solution
as a Dip Treatment (18)
Eng. Cont.
Dermal Unit
Exposure3
(mg/lb ai)
NA
NA
NA
No Data
No Data
No Data
Eng. Cont.
Inhalation
Unit
Exposure11
(Mg/lb ai)
NA
NA
NA
No Data
No Data
No Data
Range of
Application
Rates'
(Ib ai/A)
0.002 Ib
ai/gal
0.01 Ib ai/gal
5.5 Ib ai/A
0.68 Ib ai/A
1.41bai/A
4. lib ai/A
0.68 Ib ai/A
1.41bai/A
4. lib ai/A
No Data
No Data
No Data
Crop Type or
Target4
Turf&
Ornamentals
Turf
Turf
Turf
No Data
No Data
No Data
Amount
Handled
per Day6
40 gallons
5 acres
5 acres
5 acres
No Data
No Data
No Data
Eng. Con.
Daily
Dermal
Exposure5
(mg/day)
NA
NA
NA
NA
No Data
No Data
No Data
Eng. Con.
Daily
Inhalation
Exposure8
(mg/day)
NA
NA
NA
NA
No Data
No Data
No Data
Eng. Cont.
Total Daily
Dose
(mg/kg/day)11
NA
NA
NA
NA
No Data
No Data
No Data
Number of
Exposures per
Year1
8/ 80
8/ 80
8/ 80
8/ 80
8/ 80
8/ 80
8/80
8/80
8/80
No Data
No Data
No Data
Eng. Cont.
LADD
(mg/kg/day)
NA
NA
NA
NA
No Data
No Data
No Data
Eng. Cont.
Total Cancer
Riskk
NA
NA
NA
NA
No Data
No Data
No Data
Flagger Risk
Flagging Spray Applications (19)
0.00022
0.007
0.5 Ib ai/A
1 Ib ai/A
Ag
350 acres
0.039
0.077
0.0012
0.0025
4.5 E-5
9.0 E-5
10/100
4/40
6.2E-7 / 6.2E-6
4.9E-7/4.9E-6
2.7E-8 / 2.7E-7
2.2E-8 / 2.2E-7
Footnotes:
a     Engineering Control Unit Exposure values represent:  la,lb,lc,ld, 3a, 3b, closed mixing and loading; 2a, 2b, 2c water soluble bags; 4,5,6,7,10, 19 enclosed cab or cockpit
b     Engineering Control Inhalation Unit Exposure reflects values taken from PHED VI. 1 surrogate exposure tables (May 1997).
c     Application rates come from values found in the LUIS report and on Iprodione labels.  See Table 7 for particular examples.
d     Crop Type or Target provides a general description of the intended uses of various products containing Iprodione.  Separate categories are presented because of the distinct differences in application rates and acres treated.
      Ag = agricultural crops and Turf =turfgrass including sod-farms, institutional areas and golf courses. Ornamentals = includes greenhouse, field, landscape, and conifer nurseries.
e     Amount Handled Per Day values are from the EPA estimates of acreage treated, or volume handled in a single day for each exposure scenario of concern based on the application method.
f     Eng. Con. Daily Dermal Exposure (mg/day) =Eng. Con. Unit Exposure (mg/lb ai) * Application Rate (Ib ai/A or Ib ai/gallon) * Amount Handled Per Day (acres/day or gallons/day).
g     Eng. Con. Daily Inhalation Exposure (mg/day) = Eng. Con. Unit Exposure (ug/lb ai) * (1 mg/1000 ug) Conversion * Application Rate (Ib ai/A or Ib ai/gallon) * Amount Handled Per Day (acres/day or gallons/day).
h     Eng  Con. Total Daily Dose = [Eng. Con Daily Dermal Exposure (mg/day) * 0.05 (Dermal Absorption  Factor) + Eng. Con Daily Inhalation Exposure (mg/day)]/Body Weight (70 kg).
I     Number of Exposures Per Year is based on maximum number of applications which represent private use. A factor of 10 was used to estimate commercial use.
j     LADD (mg/kg/day) = Eng. Con. Total Daily Dose (mg/kg/day) *  (Number of days exposure per year /365 days per year) * 35 years worked/70 year lifetime.
k     Total Cancer Risk = LADD (mg/kg/day) * (Q/), where Q/ = 4.39E-2 (mg/kg/day).
NA = Not Applicable. For scenarios 9 and 11-15 engineering controls are not  available.
                                                                                                  53

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                     (1)    Summary of Risk Concerns for Handlers, Data Gaps, and
                            Confidence in Risk Estimates

       Handler  Scenarios with Risk Concerns.   The calculations of  short-term  and
intermediate-term inhalation risk indicate that inhalation MOEs are more than 100 at baseline
for the all the assessed exposure scenarios except the following:

•      (2a) mixing/loading wettable powder for aerial/chemigation application  (at an
       application rate of 0.5 Ib ai/acre, the short-term inhalation MOE was acceptable, but
       not at an application rate of 1.0 Ib ai/acre).

       The calculations of short-term and intermediate-term inhalation risks for scenario 2a
indicates that with the additional PPE, inhalation MOEs are greater than 100.

       As noted below in the data gaps discussion, several of the exposure scenarios could
not be assessed due to lack of PHED surrogate data.

       An engineering  control assessment was  carried out for enclosed cab aerial spray
applications, and for wettable powders formulated in water soluble bags.  The calculations
of short-term and intermediate-term inhalation risks for these scenarios (Table 6) indicate that
when engineering controls are  employed  (i.e., water soluble bags and enclosed cab), the
MOEs are more than 100 for all assessed scenarios which include:

       (2a) mixing/loading wettable  powder for aerial/chemigation application,
•      (2b) mixing/loading wettable powder for  groundboom application,
•      (2c) mixing/loading wettable  powder for orchard airblast application,
•      (2d) mixing/loading wettable powder for professional application to turf with low
       pressure/high volume handgun,
•      (5) applying sprays with a fixed-wing aircraft, and
•      (6) applying sprays with a helicopter.

       The calculations indicate that cancer risks at baseline are greater than the l.OE-4 for
the following scenarios  (refer to tables for specific scenarios— for some scenarios the risks
are below l.OE-4 for private handlers or at lower application rates):
       (la) mixing/loading liquids for aerial/chemigation application,
       (Ib) mixing/loading liquids for groundboom application (at application rates of 0.5
       and greater than or equal to 1 Ib ai/acre),
       (Ic) mixing/loading liquids for  orchard airblast sprayer application  (commercial
       handlers only),
       (Id) mixing/loading liquids for professional application to turf grass using a low
       pressure/high volume handgun (to turf at an application  rate of 5.5 Ib ai/acre-
       commercial handlers only),
       (2a) mixing/loading wettable powder for aerial/chemigation application,

                                     54

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•      (2b) mixing/loading wettable powder  for groundboom  application (commercial
       handlers only),
•      (2c) mixing/loading  wettable  powder for  orchard  airblast sprayer application
       (commercial handlers only),
•      (2d) mixing/loading wettable powder for professional application to turf with a low
       pressure/high volume handgun (commercial handlers only)
•      (3a) mixing/loading dry flowables for chemigation application (commercial handlers
       only),
•      (3b) mixing/loading  dry flowables for groundboom application (to turf  at an
       application rate of 5.5 Ib ai/acre) (commercial handlers only),
•      (11) mixing/loading/applying sprays using  a low  pressure  hand wand  (  at an
       application rate of 0.01 Ib ai/gallon for turf and ornamentals, and 5.5 Ib ai/acre for
       turf) (commercial handlers only),
•      (12)  mixing/loading/applying  sprays using a high pressure hand  wand (at an
       application rate of 1 Ib ai/acre for agriculture  and 0.01 Ib ai/gallon for ornamentals)
       (commercial handlers only),
•      (14) mixing/loading/applying granulars using a belly grinder (commercial handlers
       only), and
•      (15) mixing/loading/applying granulars with a push-type granular spreader at the 4.1
       Ib rate and higher (commercial handlers only).

       The calculations indicate that cancer risks at  baseline are  in the range of l.OE-4 to
1 .OE-6 for the following scenarios (refer to tables for  specific scenarios— for some scenarios
the risks are greater than l.OE-4 for commercial handlers or at higher application rates, and
for others they are less than l.OE-6  for private handlers or at lower application rates):
       (Ib) mixing/loading liquids for groundboom application,
       (Ic) mixing/loading liquids for orchard airblast sprayer application (private handlers
       only),
       (Id) mixing/loading liquids for professional application to turf grass using a low
       pressure/high volume handgun,
       (2b) mixing/loading wettable powder for groundboom application,
       (2c) mixing/loading wettable powder for orchard airblast sprayer application,
       (2d) mixing/loading wettable powder for professional application to turf with a low
       pressure/high volume handgun (private handlers only),
       (3a) mixing/loading dry flowables for chemigation application,
       (3b) mixing/loading dry flowables for groundboom application,
       (4) loading granulars for tractor-drawn spreader applications,
       (7) applying sprays with a groundboom sprayer,
       (8) applying to orchards with an airblast sprayer,
       (10) applying granulars with a tractor-drawn spreader,
       (11) mixing/loading/applying sprays using a low pressure hand wand,
       (12) mixing/loading/applying sprays using a high pressure hand wand,
       (14) mixing/loading/applying granulars using a belly grinder,
       (15) mixing/loading/applying granulars with a push-type granular spreader, and
       (19) flagging spray applications.

                                      55

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       The calculations indicate that cancer risks at baseline are less than l.OE-6 for the
following scenarios:

•      (4) loading granulars for tractor-drawn spreader applications (at the  0.68 rate for
       private handlers only),
•      (7) applying sprays with a groundboom sprayer (all handlers at the 0.27 rate and less,
       and private handlers only at the 1.0 rate and less),
•      (10) applying granulars with a tractor-drawn spreader (private handlers only at the
       0.68 rate or less), and
•      (15) mixing/loading/applying granulars with a push-type granular spreader (private
       handlers only at the 0.68 rate or less).

       The calculations indicate that cancer risks with additional PPE are greater than 1 .OE-4
for the following scenarios (refer to tables for specific scenarios- for some scenarios the risks
are below l.OE-4 for private handlers or at lower application rates):

•      (la) mixing/loading liquids for aerial/chemigation application,
•      (2a) mixing/loading wettable powder for aerial/chemigation application,
•      (3a) mixing/loading dry flowables for chemigation application, and
•      (13) mixing/loading/applying sprays using a backpack sprayer (at an application rate
       of 5.5 Ib ai/acre to turf).
•      (14) mixing/loading/applying granulars using a belly grinder.

       The calculations indicate that cancer risks with additional PPE are in the range of
1 .OE-4 to 1 .OE-6 for the following scenarios (refer to tables for specific scenarios— for some
scenarios the risks are greater than l.OE-4 for commercial handlers or at higher application
rates, and for others  they are less than l.OE-6  for  private handlers or at lower application
rates):
       (la) mixing/loading liquids for aerial/chemigation application,
       (Ib) mixing/loading liquids for groundboom application,
       (Ic) mixing/loading liquids for orchard airblast sprayer application,
       (Id) mixing/loading liquids for professional application to turf grass using a low
       pressure/high volume handgun,
       (2a) mixing/loading wettable powders for aerial/chemigation application,
       (2b) mixing/loading wettable powder for groundboom application,
       (2c) mixing/loading wettable powder for orchard airblast sprayer application,
       (2d) mixing/loading wettable powder for professional application to turf with a low
       pressure/high volume handgun,
       (3a) mixing/loading dry flowables for chemigation application,
       (3b) mixing/loading dry flowables for groundboom application,
       (4) loading granulars for tractor-drawn spreader applications,
       (7) applying sprays with a groundboom sprayer,
       (8) applying to orchards with an airblast sprayer,

                                     56

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•      (9) applying with a low pressure/high volume handgun to turfgrass,
•      (10) applying granulars with a tractor-drawn spreader,
•      (11) mixing/loading/applying sprays using a low pressure hand wand,
•      (12) mixing/loading/applying sprays using a high pressure hand wand,
•      (13) mixing/loading/applying using a backpack sprayer,
•      (14) mixing/loading/applying granulars using a belly grinder
•      (15) mixing/loading/applying granulars with a push-type granular spreader, and
•      (19) flagging spray applications.

       The calculations indicate that cancer risks with additional PPE are less than l.OE-6
for the following scenarios:

•      (Ib) mixing/loading liquids for  groundboom application (at the 0.27 rate for all
       handlers, and for private handlers only at the 1.4 rate and less),
•      (Ic) mixing/loading liquids for orchard airblast sprayer application (at the 0.5 rate for
       all handlers and at the  1 Ib rate and less for private handlers only),
•      (Id) mixing/loading liquids for professional application to turf grass using a  low
       pressure/high volume  handgun (at the  1.4 rate for all handlers, and for private
       handlers only at the 5.5 rate),
•      (2d) mixing/loading wettable powder for professional application to turf with a low
       pressure/high volume handgun (at the 1.4 rate for private handlers only),
•      (4) loading granulars for tractor-drawn spreader applications (at the 1.4 rate and less
       for private handlers only),
•      (7) applying sprays with a groundboom sprayer (all handlers at the 0.27 rate and less,
       and private handlers only at the 1.4 rate and less),
•      (8) applying to orchards with an airblast sprayer  (private handlers only  at the 0.5 rate
       or less),
•      (10) applying granulars with a tractor-drawn spreader (private handlers only at the 1.4
       rate or less), and
•      (11) mixing/loading/applying sprays using a low pressure hand wand (all handlers at
       rates of 0.01 Ib ai/gallon or less),
•      (13) mixing/loading/applying using a backpack  sprayer (all handlers at the 0.002 Ib
       ai/gallon rate or less, and private handlers only at rates of 0.01 Ib ai/gallon or less),
•      (15) mixing/loading/applying granulars with a push-type granular spreader (private
       handlers only at the 0.68 rate or less), and
•      (19) flagging spray applications (private flaggers only).

       The calculations indicate that cancer risks with engineering controls are greater than
l.OE-4 for none of the exposure scenarios.

       The calculations  indicate  that cancer  risks with  Engineering  Controls (closed
mixing/loading, water soluble bags, enclosed cab or airplane cockpit) are in the range of 1 .OE-
4 to l.OE-6 for the following scenarios (refer to tables for specific scenarios— for some
scenarios the risks are less than l.OE-6 for private handlers or at lower application rates):

                                      57

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       (la) mixing/loading liquids for aerial/chemigation application,
       (Ib) mixing/loading liquids for groundboom application,
       (2a) mixing/loading wettable powders for aerial/chemigation application,
       (2b) mixing/loading wettable powder for groundboom application,
       (2c) mixing/loading wettable powder for orchard airblast sprayer application,
       (2d) mixing/loading wettable powder for professional application to turf with a low
       pressure/high volume handgun,
       (3 a) mixing/loading dry flowables for chemigation application,
       (3b) mixing/loading dry flowables for groundboom application,
       (5) applying sprays with fixed wing aircraft,
       (6) applying sprays with a helicopter,
       (7) applying sprays with a groundboom sprayer,
       (8) applying to orchards with an airblast sprayer,
       (10) applying granulars with a tractor-drawn spreader,
       (19) flagging spray applications.
       The calculations indicate that cancer risks with Engineering Controls are less than
l.OE-6 for the following scenarios:

       (Ib) mixing/loading liquids for groundboom application (all applications at the rate
       of 0.27 Ibsai/A only)
•      (Ic) mixing/loading liquids for orchard airblast sprayer application,
•      (Id) mixing/loading liquids for professional application to turf grass using a low
       pressure/high volume handgun,
•      (2b) mixing/loading wettable powder for groundboom application (private handlers
       only),
•      (2c) mixing/loading wettable powder for  orchard airblast sprayer application (all
       handlers at the 0.5 rate, and private handlers only at the  1.0 rate),
•      (2d) mixing/loading wettable powder for professional application to turf with a low
       pressure/high volume handgun (all handlers at the rate of 1.4 Ib ai/A and private
       handlers only at the rate of 5.5 Ib ai/A),
•      (3b) mixing/loading dry flowables for groundboom application (private handlers only
       at the 1.0 rate or less),
       (4) loading granulars for tractor-drawn spreader applications,
       (5) applying sprays with fixed wing aircraft (private applicators only),
       (6) applying sprays with a helicopter (private applicators only),
       (7) applying sprays with a groundboom sprayer (all applicators at the 0.27 rate, and
       private applicators only at all other rates),
       (8) applying to orchards with an airblast sprayer (all applicators at the 0.5 Ib ai/A rate
       and private applicators only at the 1.0 rate),
       (10) applying granulars with a tractor-drawn spreader (private applicators only all
       rates),
       (19) flagging spray applications (flaggers supporting private applications only).
                                      58

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Data Gaps. Data gaps exist for the following scenarios:

•      (9) - no chemical specific or PHED baseline dermal data exist for applying with a low
       pressure/high volume handgun to turfgrass.
•      (18) - no chemical specific or PHED data exist for mixing/loading/applying solution
       as a dip treatment.

       Data Quality and Confidence in Assessment.  Several issues must be considered when
interpreting the occupational exposure risk assessment. These include:

•      No  chemical specific data were provided; therefore, surrogate PHED data were used
       to assess exposure.

•      Several handler assessments were completed using "low quality" PHED data due to
       the  lack of a more acceptable data set (see Table 3 for the specific scenarios where
       only "low quality" data were available).

•      Several generic protection factors were used to calculate handler exposures. These
       protection factors are general estimates and variability may be significant.

•      Factors used to calculate daily exposures to handlers (including acres treated per day
       and gallons of liquid applied) are based on label directions and professional judgement
       for  the broad range of sites, equipment, and methods  that are possible for each
       scenario.

•      Estimates of risk range from average or "typical" for private handlers, to high end for
       commercial handlers (i.e.,  it is possible but not likely that the actual risks to some
       commercial handlers could exceed those estimated here).

              e.      Occupational Post-Application Exposures and Risks

                     (1)    Postapplication Exposure Scenarios

       The Agency has determined that there are potential Postapplication exposures to
individuals entering treated areas for the purpose  of:

•      Harvesting tree fruits and nuts, low-growing fruits, vegetables, and grapes;

•      Pruning and propping fruit and nut trees;

•      Harvesting and mowing of sod farm turf;

•      Pruning, transplanting, and bundling flowers, ornamental shrubs, and vines; and

•      Transplanting trees and other ornamentals.

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       The specific crop group/activity combinations likely to result in Postapplication
exposures from iprodione are listed below. These crop groups/activities were grouped based
on assumed exposure level, preharvest interval (PHI), maximum number of applications per
season and expected frequency  of exposure.  These crop groups/activities include the
following:

•      Grape harvesting, pruning, and staking:  assumed to result in higher exposures than
       other activities such as propping or staking which would have a longer PHI and lower
       number of days  of exposure;

•      Stone fruit harvesting: assumed to result in higher exposures than other activities that
       have lower days of exposure;

•      Almond harvesting: assumed to result in high exposure levels, but with lower PHI and
       lower application rates than stone fruit harvesting;

•      Harvesting of small vegetables and fruits, including strawberries:  assumed to result
       in higher exposures than activities such as scouting, thinning, or weeding, which have
       lower exposure  frequencies;

•      Harvesting dry bulb onions:  assumed to have lower exposure frequencies than the
       harvesting of small fruits and vegetables group above;

•      Non-harvesting  activities such as weeding and scouting for crops such as beans, rice,
       lettuce, potatoes, and peanuts: assumed to have lower exposure levels and lower
       exposure frequencies than the harvesting scenarios;

•      Ornamental shrub, vine and herbaceous plant harvesting, transplanting, pruning, and
       bundling  of flowers: assumed to have high exposure levels and high  exposure
       frequencies, and with greater application rates than fruits and vegetables;

•      Sod farm harvesting and mowing: harvesting assumed to have high levels of exposure,
       but with low frequency; combined with  low level more frequent exposures on days
       of mowing;

•      Golf course mowing and maintenance: assumed to have low exposure levels, and high
       exposure frequency combined with high application rates and the potential for high
       number of applications per season; and

•      Ginseng harvesting, scouting and weeding:  assumed to be a discrete crop/activity set
       that would result in different exposures than those listed above.

       One of these crop group/activities has been identified as a scenario yielding potential
chronic exposure (i.e., > 180 days of exposure/year) concern. These risks are summarized
in Table 13.  The potential chronic exposure reentry activities include:

                                     60

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       •      Transplanting, pruning, and bundling of ornamentals: assumed to be a high-exposure
              level (Tc = 7,000 cm2/hr) activity. Over a lifetime, the average exposure level is likely
              to be lower (i.e., see cancer assessment, Tc = 2,400 cm2/hr) due to variability in use
              over many years compared to variability in use over one year. Iprodione may be used
              more frequently in a particular year, such as to control disease potential, or a long
              duration in a rotational program.

              All the crop groups and activities likely to result in Postapplication exposure from
       iprodione have been assessed for cancer risk.

                            (2)    Data Sources and Assumptions for Scenarios Considered

       No chemical-specific Postapplication human reentry  or transferable  residue  data were
submitted in support of the Reregi strati on  of Iprodione.   In  lieu of these  data, a surrogate
Postapplication exposure assessment was conducted to determine potential risks for the previously
mentioned representative scenarios.

       Assumptions Used in Postapplication Exposure Calculations (Cancer and Non-Cancer Risks).
The assumptions used in the calculations for occupational Postapplication risks include the following
items, which are also summarized in Table 14.

•      Application rates  used for the calculations were derived using the following strategy:

              Harvesting grapes = 0.75 Ib ai/acre, which is the lower end of application rate range
              (0.75 and  1.0 Ib ai/acre)
              Harvesting dry bulb onions = 0.5 Ib ai/acre which is the lower end of application rate
              range (0.5 and 0.75 Ib ai/acre)
              Weeding and scouting non-harvest vegetables, including beans, rice, potatoes, lettuce
              and peanuts = 0.75 Ib ai/acre which is the average of application rates (0.5, 0.75, and
              1.0 Ib ai/acre)
              Transplanting, pruning, bundling of ornamental and flowers = 3.0 Ib ai/acre which is
              representative of the application rate range (1.4 and 4.0 Ib ai/acre)
              Harvesting and  mowing sod  farm  turf =4.1 Ib  ai/acre which is the average of
              application rates (2.7 and 5.5 Ib ai/acre)
              Mowing and maintenance of golf course turf = 3.0 Ib ai/acre which is the lower end
              of the range of application rates (2.7 and  5.5 Ib ai/acre) (expected to have frequent
              prescriptive treatments rather than occasional corrective treatments).
                                            61

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Table 13.  Occupational Postapplication Chronic Risks from Iprodione
Days
After
Treatment
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Ornamentals3 - 20% initial residue
DFR Og/cm2)b
6.7
6.1
5.4
4.9
4.4
4.0
3.6
3.2
2.9
2.6
2.3
2.1
1.9
1.7
1.5
1.4
Dermal Dose
(mg/kg/day)c
0.27
0.24
0.22
0.20
0.18
0.16
0.14
0.13
0.12
0.10
0.094
0.084
0.076
0.068
0.062
0.055
MOEd
23
25
28
31
35
38
43
47
53
59
65
72
80
89
99
110
Ornamentals3 - 10% initial residue
DFR Og/cm2)b
3.4
3.0
2.7
2.5
2.2
2.0
1.8
1.6
1.5
-
-
-
-
-
-
-
Dermal Dose
(mg/kg/day)c
0.14
0.12
0.11
0.098
0.088
0.079
0.071
0.064
0.058
-
-
-
-
-
-
-
MOEd
45
50
56
62
69
77
85
95
100
-
-
-
-
-
-
-
Ornamentals3 - 5% initial residue
DFR Og/cm2)b
1.7
1.5
-
-
-
-
-
-
-
-
-
-
-
-
-
-
Dermal Dose
(mg/kg/day)c
0.067
0.061
-
-
-
-
-
-
-
-
-
-
-
-
-
-
MOEd
91
100
-
-
-
-
-
-
-
-
-
-
-
-
-
-
FOOTNOTES
a   This scenario represents the repotting, transplanting, harvesting and pruning of indoor and outdoor ornamentals..  Assumptions include an average application rate of 3.0 Ib
    ai/acre, and a transfer coefficient (Tc) of 7,000 cm2/hour, and hours exposed per day = 8 hours.
b   DFR values derived from surrogate data - Assumed to be 20%, 10%, and 5% of the application rate initially, with a 10% dissipation thereafter.
c   Dermal Dose (mg/kg/day) =([DFR (^g/cm2]* transfer coefficient (Tc) * hours worked per day at the stated activity * 0.001 mg///g * 0.05 dermal absorption rate/70 kg body
    weight.
d   MOE = NOEL (mg/kg/day)/Dermal Dose (mg/kg/day), where NOEL = 6.1 mg/kg/day.
                                                                            62

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Table 14.  Occupational Postapplication Scenarios and Assumptions for Iprodione
Exposure Activity /Crop or Target
Grapesb(Harvesting/Pruning/Staking)
Almond Treesc(Harvesting)
Stone Fruit Trees4 (Harvesting)
Small Vegetables and Fruits, inc. Strawberries6 (Harvesting)
Dry Bulb Onions5 (Harvesting)
"Non-Harvest Activities in Vegetables, including beans, rice,
lettuce, potatoes, peanuts8 (e.g., weeding, scouting)
Ornamentals11 (Harvesting/Transplanting/ Pruning/Bundling
Flowers)
Sod Farms1 (Harvesting/Mowing)
Golf Course Turf (Mowing/Maintenance)
Ginsengk(Harvesting/Scouting/Weeding)
Application
Rate
(Ib ai/acre)
0.75
0.5
0.75
0.75
0.5
0.75
3
4.1
3
0.75
Transfer
Coefficient(cm2//
hr)
10,000
10,000
10,000
3,500
3,500
1,000
2,400
1,000
500
7,000
Exposure Days
per Year
110
60
60
120
30
25
180
50
90
10
Hours
Worked
per Day
8
8
8
8
8
8
4
8
4
1
Maximum Number of
Applications per Season
4
4
4
2-10
5-10
2-4
NA
NA
NA
10
Application Interval
(days)
7
7-14
7-14
7-14
7-14
7-14
as required
(assume 14 days)
14
14
7-14
PHI3 (days)
7
NS (assume
zero)
7
0
7
NA
NA
NA
NA
36
Footnotes:
NA = Not applicable
NS = Not specified
a    PHI values come from Iprodione labels.
b    Application rate = lower end of range (0.75 and 1.0 Ib ai/acre).
c    Application rate = stated rate of 0.5 Ib ai/acre.  Days of exposure = 12 weeks x5 days/week.  PHI was not specified on label, and assumed to be zero days.  Application interval on Iprodione labels not specified in days.
     Label guideline suggests first application pink bud, 2nd at full bloom, 3rd at petal fall and 4th application at up to 5 weeks after petal fall.  For purposes of this assessment, application interval was assumed to be every
     7-14 days.
d    Application rate = average of 0.5 and 1.0 Ib ai/acre rates.
e    Application rate = average of rates (0.5 and 1.0 Ib ai/acre).  Days of exposure = 5-6 days/week, and 6-8 months per year.
f    Application rate = lower end of range (0.5 and 0.75 Ib ai/acre).
g    Application rate = average of rates (0.5, 0.75 and 1.0 Ib ai/acre). Days of exposure = once/week x 6 months.  The risk calculations are based on an average application interval of  7-14 days. Two crops in this grouping
     have unique intervals:
     •     Risks to  weeders andscouters of bean fields may be slightly underestimated because workers may be entering the fields closer to the time of application (i.e., 5 to 7 day application intervals), but this is expected
          to be offset by the low number of applications per season (i.e., 2).
     •    Risks to peanut farm workers may be slightly overestimated because the application interval for peanuts is 21 days and workers are expected to be entering fields later than the average reentry interval used for this
          calculation.
h    Application rate = average of rates (2 and41b ai/acre). Days of exposure = 5-6 days/week for 6-8 months/year period of pest pressure.
i    Application rate = average of rates (2.7 and 5.5 Ib ai/acre). Days of exposure = 50 weeks x 1 day/week. Transfer coefficient = weighted average of high exposure activity (harvesting) and low exposure activity (mowing).
j    Application rate = lower end of range (2.7 and 5.5 Ib ai/acre).
k    Application rate = average of rates (0.5 and 1.0 Ib ai/acre).
                                                                                                 63

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       Harvesting, scouting, and weeding of ginseng = 0.75 Ib ai/acre which is the average
       of application rates (0.5 and 1.0 Ib ai/acre)

Transfer coefficients (Tc) are assumed to be 10,000 cm2/hr for high-contact harvesting (i.e.,
fruit and nut trees and grapes). A transfer coefficient of 7,000 cm2/hr was assumed for the
chronic assessment of ornamental nursery and greenhouse activities; however, a 2,400 cm2/hr
transfer coefficient was used in the cancer assessment for ornamentals to reflect variation in
use over a lifetime.  The 2,400 cm2/hr transfer coefficient is the median and mode (i.e., most
frequently occuring value) in a data set ranging from 496 cm2/hr to 10,000 cm2/hr for transfer
coefficients associated with ornamental work (Browner et. al.,1992 and Veerman et. al.,
1994). Transfer coefficients are assumed to be 3,500 cm2/hr for harvesting of low- growing
fruit and vegetable crops (e.g., strawberries) and 1,000 cm2/hr for activities such as weeding
and scouting of low growing vegetables. A transfer coefficient of 1,000 cm2/hr was estimated
for harvesting and mowing of sod farms and is an average of the frequent but low Tc activities
of mowing and infrequent  but high Tc activity of harvesting.   Golf course mowing and
maintenance activities were assessed using a Tc of 500 cm2/hr.

Daily exposure is assumed to occur for 8 hours per day except for ornamental work (cancer
assessment only), mowing and maintenance of golf course turf, and harvesting and scouting
of ginseng.  It is assumed that nursery and greenhouse workeres will  harvest, transplant,
prune, and bundle, and golf course workers will tend fairways and greens, only half of their
work day when averaged over a lifetime.

Postapplication exposures to scouts and harvesters of ginseng farms are expected to be of
high intensity, but for short periods of time (e.g., 1 hour per day for 10 days of the year).

The average body weight of 70 kg is used, representing a typical adult.

Exposure frequency is estimated to be 60 days/year for harvesting of fruit and nut trees (i.e.,
12 5-day work weeks), 110 days/year for grapes, 120 days/year for small fruit and vegetable
harvesting (including strawberries), 90  days/year for golf course mowing,  180 days/year for
activities involving ornamentals, 50 days for sod farm maintenance, 30 days for harvesting of
dry bulb onions, 25 days for non-harvesting activities such as weeding and scouting low
growing vegetables, etc., and 10 days/year for ginseng harvesting and scouting.

Exposure duration is assumed to be 35 years.  This represents a typical working lifetime.

Lifetime is assumed to be 70 years.

Dermal absorption is assumed to be 5 percent, as in the handler assessment1.

The Ql* used in the cancer assessment is 4.39 X  10"2 mg/kg/day.
                                 64

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       •       Restricted Entry Intervals (REIs): The Restricted Entry Intervals were estimated by selecting
               the earliest day after application for which the estimated DFR yields a cancer risk of less than
               1E-4. DFRs were assumed to be 20 percent of the application rate initially, with a 10 percent
               dissipation each day thereafter. Because actual DFR data are not currently available, and 20
               percent initial DFRs may be an overestimate, REIs are also presented which correspond to
               DFRs derived from an initial 10 percent and five percent of the application rate. These DFRs
               may still be an overestimate for iprodione.

                             (3)    Postapplication Exposure and Non-Cancer Risk Estimates

       The chronic Postapplication risks from Iprodione have been assessed using surrogate regression data.
The DFR is derived from the application rate assuming an estimated 20 percent of the rate applied as initial
dislodgeable residues, and an estimated 10 percent dissipation rate per day6. Because actual dissipation data
are not currently available, and 20 percent initial dislodgeable residue may be an overestimate, DFRs are also
calculated using an estimated ten percent and five percent initial dislodgeable residue.  The equations used
for the calculations in Table 13 are presented below.

Dislodgeable foliar residues (DFRs) were calculated as follows:

                                    I us\     ( lb ai\      ( us/cm2]
                                DFR -Z2- \ = AR\ —^ \  x CF\ Ma     x F x (I - DR)'
                                    (cm2)     (  A }      (lb ailAj

Where:
     AR   =   average application rate which is highlighted in Table 13
     CF   =   conversion factor is 11.2 lb per cmVlb ai per acre
     F    =   fraction retained on foliage (20 percent, 10 percent, and 5 percent) T
     DR   =   daily dissipation rate  (10 percent per day)
     t     =   days after treatment, and is an assumed average reentry day identified in Table 13.

Daily Absorbed Doses were calculated as follows:

                                (DFR Og/cm2) x Tc (cm2lhr) x CF   * mg  } x Abs x ED (hrslday))
                    „    .   ,,  , A                             I 1,000 Lig]
                   Dose (mglkgla) = 	i—	-S-L	
Where:
     DFR  =    daily DFR, as calculated above for the assumed average reentry day
     Tc   =    transfer coefficient; 7,000 cmVhr for the transplanting, pruning, repotting, and bundling of ornamental
                shrubs, trees, vines and flowering and foliage plants
     CF   =    conversion factor (i.e., 1 mg/1,000 /j,g)
     Abs  =    dermal absorption (assume 5 percent)
     ED   =    exposure duration; 8 hours worked per day for transplanting, pruning, bundling of ornamentals
     BW  =    body weight (70 kg)
Chronic MOEs were calculated as follows:

                                                  65

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                                  „,   .  , ,„„   NOEL (mglkglday)
                                  Chrome MOE = 	\ & &—u_
                                              Dose (mglkglday)
Where:

      NOEL     =     6.1 mg/kg/dayl
      Dose =    calculated absorbed dermal dose

Table 13  presents the chronic dermal MOEs for the scenario identified with concern for potential
chronic occupational exposure.

                      (4)             Postapplication Exposure and Risk Estimates for Cancer

           Total cancer risk calculations were made using the formulas for DFR, LADD, and risk
      presented below.  Certain assumptions, including transfer coefficient, application rate, and
      exposure duration, change with the different scenarios or activities.  The assumptions used in
      the iprodione DFR Postapplication risk calculations are described in the footnotes to Table 14,
      and are also summarized in the data assumptions section. The estimated cancer risks, assuming
      an initial 20 percent, 10 percent, and 5 percent DFR, are presented in Table 15.
      DFRs were calculated as follows, where:
                                                CF         * F *
                                                   (ib ailA
         AR =        application rate. See Table 15, or Postapplication assumptions section for applicable rates
                      for each Postapplication scenario
         CF =        conversion factor is 11.2 ,wg/cm2 per Ib/acre
         F   =        fraction retained on foliage (20 percent, 10 percent and 5 percent)
         DR =        daily dissipation rate (10 percent per day)
         t   =        days after treatment. See Table 14 for the restricted entry interval (this is the day on which
                      the cancer risk estimate is based for each individual scenario).

    Lifetime Average Daily Dose (LADD) is calculated as follows:

                               LADD = DFR  * Tc * ET * EF * ED * mg/1000 //g  * ABS
                                                 BW * LT * 365 dlyr

Where:
         DFR=        dislodgeable foliar residue on day "t" (^g/cm2)
         Tc=          transfer coefficient (cm2/hr) (see Table  14 or Postapplication assumptions discussion)
         ET=         exposure time (hr/day) (see Table 14 or Postapplication assumptions discussion)
         EF=         exposure frequency (days/year) (see Table 14 or Postapplication assumptions discussion)
         ED=         exposure duration (35 years)
         ABS=        absorption factor (0.05);
         BW =        body weight (70 kg)
         LT =         lifetime (70 years).


                                               66

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Table 15.  Occupational Postapplication Cancer Risks from Iprodione
Exposure Activity/Crop
or Target
Grapes (Harvesting/Pruning/Staking)
Almond Trees (Harvesting)
Stone Fruit Trees (Harvesting)
Small Vegetables and Fruits, inc. Strawberries
(Harvesting)
Dry Bulb Onions (Harvesting)
"Non-Harvest Activities in Vegetables, including
beans, rice, lettuce, potatoes, peanuts
(e.g., weeding, scouting)
Ornamentals - 1 80 days
(Harvesting/Transplanting/Pruning/Bundling
Flowers)
Sod Farms (Harvesting/Mowing)
Golf Course Turf (Mowing/Maintenance)
Ginseng (Harvesting/Scouting/Weeding)
20% Initial Dislodgeable Residues"
REI
(day)'
18
8
12
8
0
0
16
4
0
0
DFR
(,ug/cm2)c
0.25
0.48
0.47
0.72
1.12
1.68
1.25
6.03
6.73
1.68
LADD
(mg/kg/day)11
2.2E-03
2.3E-03
2.2E-03
2.4E-03
9.2E-04
3.3E-04
2.1E-03
2.4E-03
1.2E-03
1.2E-04
Cancer Risk'
9.5E-05
9.9E-05
9.8E-05
l.OE-04
4.0E-05
1.4E-05
9.2E-05
l.OE-04
5.2E-05
5.1E-06
10% Initial Dislodgeable Residues"
REI
(day)"
11
1
5
2
0
0
9
0
0
0
DFR
(//g/cm2)c
0.26
0.50
0.50
0.68
0.56
0.84
1.30
4.60
3.36
0.84
LADD
(mg/kg/day)11
2.3E-03
2.4E-03
2.3E-03
2.2E-03
4.6E-04
1.6E-04
2.2E-03
1.8E-03
5.9E-04
5.8E-05
Cancer Risk'
l.OE-04
l.OE-04
l.OE-04
9.8E-05
2.0E-05
7.2E-06
9.7E-05
7.9E-05
2.6E-05
2.5E-06
5% Initial Dislodgeable Residues"
REI
(day)"
4
0
0
0
0
0
2
0
0
0
DFR
(//g/cm2)c
0.28
0.28
0.42
0.42
0.28
0.42
1.36
2.30
1.68
0.42
LADD
(mg/kg/day)11
2.4E-03
1.3E-03
2.0E-03
1.4E-03
2.3E-04
8.2E-05
2.3E-03
9.0E-04
3.0E-04
2.9E-05
Cancer Risk'
l.OE-04
5.8E-05
8.7E-05
6.1E-05
l.OE-05
3.6E-06
l.OE-04
3.9E-05
1.3E-05
1.3E-06
Footnotes:

a
b
c
Actual dissipation data are not available; therefore surrogate DFR values were calculated based on estimated initial dislodgeable residues of 5, 10, and 20 percent.
REIs are estimated by selecting the earliest day after application for which the estimated DFR yields a cancer risk of less than 1E-4.
Surrogate DFR values derived from Residential SOPs. Surrogate DFR (/^g/cm2) = Application rate (Ib ai/acre) x Conversion factor (/^g/cm2/lb ai/acre) x fraction of active ingredient
retained on foliage. Fraction = 0.2, 0.1, and 0.05 for day zero, and dissipates 10% daily thereafter.
LADD = [DFR (Aig/cm2) x Tc (cm2/hr) x mg/1,000 /^g x hours exposed/day x exposure days/year x years of exposure x dermal absorption factor] / [body weight in kg x lifetime x
365 days/yr]., where adult body weight = 70 kg, dermal absorption factor is 5%, lifetime = 70 years, years of exposure is assumed to be 35 years, and the DFR value is assumed to
stay constant over time for the days exposed (no actual DFR values available for multiple applications over time).
Cancer Risk = LADD (mg/kg/day) x Ql* (mg/kg/day), where Ql*  = 4.39E-2.
                                                                                 67

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       Total cancer risks were calculated using the following formula:

                         RISK = LADD * Ql'

where, Ql* = 4.39 X 10'2 (mg/kg/day)'1.

Summary of Postapplication Risk Concerns, Data Gaps, and Confidence in Estimates

       Postapplication Scenarios with Risk Concerns.  The results of the chronic dermal risk
assessment indicate that an acceptable MOE (>100)  is reached for the transplanting and
pruning of ornamentals scenario on the 15th, 8th, and 1st day after treatment for 20 percent,
10 percent, and 5 percent initial DFR, respectively.

       The results of the cancer risk assessment, presented in Table 15, indicate that REIs
for the various crop  groupings range from 0-days to 18-days assuming an initial 20 percent
DFR; 0-days to 11-days assuming an initial 10 percent DFR; and, 0-days to 4-days assuming
an initial 5 percent DFR.  Although the default assumption for the initial DFR is 20 percent,
assessments were conducted using 10 and 5 percent initial DFR to provide a range in the case
that the actual DFR is lower.  At this time, the Agency believes that each scenario is likely to
be an overestimate of the post-application cancer risk from iprodione due to the conservative
nature of the surrogate dislodgeable residue data.

       Based on the lack of data regarding dislodgeable residues for iprodione, and the
likelihood that the actual DFR is closest to 5 percent (i.e.,  data from  similar compounds
indicate this), a 48-hour restricted-entry interval for iprodione use on grapes and ornamentals
will be required, and a 24-hour restricted-entry interval for all other uses of iprodione will be
required. Although  a 4-day restricted-entry interval is indicated for the grapes scenario, the
Agency at this time believest that this is overly conservative when considering the percent of
the crop treated with iprodione (10 percent) and the average number of applications (1.2) as
documented in  Agricultural Chemical Usage — Fruits 1994 Summary (July 1995).  The
Agency will revisit these restricted-entry interval decisions when actual chemical-specific
dislodgeable residue data is available and reviewed (to be submitted October 2000).

                     (5)    Data Gaps, Quality, and Confidence

       The following data gaps or uncertainties are associated with this assessment:

•      No  chemical-specific exposure or transferable residue data were submitted.  As a
       result, all analyses were completed using surrogate data from sources such as PFtED
       and assumptions related to the behavior and environmental fate of the chemical in the
       environment (e.g., dissipation of transferable residues).

•      Factors  used to calculate postapplication risks (e.g., hours  exposure per day or
       average reentry day) are based on labeling directions and best professional judgment
       due to lack of data specific to each crop/activity  combination.
                                     68

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 •      The number of significant figures used to report cancer risks may indicate greater
       precision than the conservative default assumptions and data reliability can provide.
 •      Crop groupings for the postapplication assessment are representative of general
       ranges of expected levels of exposure, and are based on application rate, PHI,
       exposure  activity, and exposure  duration.  Risks may vary within these  crops
       groupings.
 •      DFRs are estimated using the  residential  SOPs. The SOPs are designed to yield
       conservative estimates of residue levels. For Iprodione, however, these estimates may
       be  less conservative  because  (1) environmental fate information indicates that
       Iprodione is likely to degrade more slowly  than the 10% per day from the SOPs, and
       (2) potential additive effects of multiple applications have not been factored into the
       estimated DFRs.

                    (6)    Residential and other Non-occupational Exposures and
                           Risks

                           (a)    Residential Handler Exposure Scenarios - Data and
                                  Assumptions

       Residential handler  exposure  assessments were completed by  EPA assuming  a
"baseline" exposure scenario (for homeowners, short sleeved  shirt, short pants, shoes and
socks, and no gloves or respirator). PHED values used to estimate daily unit exposure values
were  taken from  the Standard Operating Procedures (SOPs) for Residential Exposure
Assessments  document dated December  1997.   Table 16 summarizes the  caveats and
parameters specific to the surrogate data  used for  each  scenario and corresponding
exposure/risk assessment.  The following  assumptions and factors were  used in the
assessment:

•      Maximum application rates for specific crops as recommended by the iprodione labels
       were used to bracket risk levels associated with the various use patterns. No use data
       were provided concerning the application rates that are commonly used for iprodione
       by homeowners, though survey data indicate that is common for homeowners to apply
       maximum (or higher) rates.
•      Generally, the use of PPE and  engineering controls are not considered feasible or
       appropriate for homeowners.
•      For homeowner turf management, the following estimates of the square feet of a
       homeowners garden were used: 20,000 ft2 for lawns areas, and 1,000 ft2 for spot
       treatments.
•      Estimates of spray application to small vegetable gardens and lawns include: 5 gallons
       per day for low pressure handwand and backpack sprayers, and 50 gallons per day for
       garden hose-end sprayers.
•      PHED values represent a handler wearing  short sleeve shirt, short pants, shoes and
       socks, and no gloves or respirator.

       Table 17 presents the residential handler exposures and short-term and intermediate-
term inhalation risks for iprodione.

                                    69

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Table 16.  Residential Exposure Scenario Descriptions for the Use of Iprodione
Exposure Scenario (Number)
Data Source
Standard Assumptions'1
Comments'1
Mixer/Loader/ Applicator Descriptors
Mixing/Loading/Applying Sprays with a
Low Pressure Handwand (1)
Mixing/Loading/Applying Using a
Backpack Sprayer (2)
Mixing/Loading/Applying Using a Garden
Hose-end Sprayer (3)
Mixing/Loading Granulars Using a Belly
Grinder (4)
Loading/ Applying Granulars Using a
Push-type Lawn Spreader (5)
Loading/ Applying Granulars by Hand as
a Spot Treatment (6)
SOPs for Residential
Exposure Assessments
(12/97)
SOPs for Residential
Exposure Assessments
(12/97)
SOPs for Residential
Exposure Assessments
(12/97)
SOPs for Residential
Exposure Assessments
(12/97)
SOPs for Residential
Exposure Assessments
(12/97)
SOPs for Residential
Exposure Assessments
(12/97)
5 gallons for small vegetable gardens.
trees and ornamentals; and 20,000 ft2
for turf
5 gallons on fruit/nut trees,
ornamentals, and small vegetable
gardens; and 20,000 ft2 for turf
50 gallons on trees, ornamentals and
small vegetable gardens; and 20,000
ft2 for turf
20,000 ft2 and 1,000 ft2 for turf
20,000 ft2 and 1,000 ft2 for turf
1,000 ft2
Baseline: Dermal and inhalation data = ABC grades, and hands data = All grade. Dermal = 9-80 replicates; hands = 70
replicates; and inhalation = 80 replicates. Low confidence in hands, dermal data. Medium confidence in inhalation data.
PPE and Engineering Controls: Not required for assessment.
Baseline: Dermal = AB grade; inhalation = A grade; and hands = C grade. Dermal = 9 to 11 replicates; hands = 11
replicates; and inhalation = 11 replicates. Low confidence in dermal, and inhalation data. A 90% protection factor was
used to back calculate "no glove" hand data from the gloved scenario.
PPE and Engineering Controls: Not required for assessment.
Baseline: Dermal and inhalation = C grade, and hands = E grade. Dermal, inhalation, and hands = 8 replicates each.
Low confidence in all data.
PPE and Engineering Controls: Not required for assessment.
Baseline: Dermal and hands data = ABC grades, inhalation = AB grade. Dermal 20-45 replicates; hands = 23 replicates;
and inhalation = 40 replicates. Medium confidence for hands, dermal and high confidence for inhalation.
PPE and Engineering Controls: Not required for assessment.
Baseline: Dermal and Hands data = C grade, and inhalation data = B grade. Hand = 15 replicates; dermal = 0-15
replicates; and inhalation =15 replicates. Low confidence in hands, dermal data, and high confidence in inhalation data.
A 50% protection factor was used to "back calculate" a short sleeved shirt value from long sleeve shirt data.
PPE and Engineering Controls: Not required for assessment.
Baseline: Dermal, hands and inhalation data = ABC grade. Hands, dermal and inhalation = 16 replicates. Medium
confidence in all data. A 90% PF was applied to gloved hands data to back calculate "no glove" hand exposure.
PPE and Engineering Controls: Not required for assessment
NA
Standard Assumptions based on EPA estimates.
"Best Available" grades are defined by EPA SOP for meeting Subdivision U Guidelines. Best available grades are assigned as follows: matrices with grades A and B data and a minimum of 15
replicates; if not available, then grades A, B andC data and a minimum of 15 replicates; if not available, then all data regardless of the quality and number of replicates. Data confidence are assigned
as follows:  High= grades A and B and 15 or more replicates per body part; Medium= grades A, B, and C and 15 or more replicates per body part;
Low= grades A, B, C, D and E or any combination of grades with less than 15 replicates.
  =  Not Applicable
                                                                                       70

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                     (7)     Residential  Handler Exposure and  Risk Estimates  for
                            Cancer

       Calculations of lifetime average daily dose (LADD) and cancer risk were performed
using the formulas presented previously for the occupational handler cancer assessment.
Table 18 presents potential cancer risk estimates from dermal and inhalation exposures to
iprodione from residential handling activities.

              f.      Summary of  Risk Concerns for Homeowner-Handlers, Data
                     Gaps, and Confidence in Exposure and Risk Estimates

       Short and intermediate-term inhalation risks for homeowner-handlers were assessed
as well as total cancer risks.

       Homeowner Handler Risks.  The calculations of short-term and intermediate-term
inhalation risks indicate that inhalation MOEs are greater than 100 at baseline for all scenarios
considered:

•      (1) mixing/loading/applying sprays with a low pressure handwand;
•      (2) mixing/loading/applying using a backpack sprayer;
•      (3) mixing/loading/applying using a garden hose-end sprayer;
•      (4) loading/applying granulars using a belly grinder; and
•      (5) loading/applying granulars with a push-type lawn spreader; and
•      (6) loading/applying granulars by hand as spot treatments.

       The calculations of potential total cancer risk to  homeowner handlers indicate that
risks are greater than l.OE-6 for the following scenarios:

•      (1) mixing/loading/applying sprays with a  low pressure handwand (turf and small
       fruits and vegetables only);
•      (2) mixing/loading/applying using a backpack sprayer (turf only);
•      (3) mixing/loading/applying using a garden hose-end sprayer (all sites except trees);
•      (4) loading/applying granulars using a belly grinder for broadcast treatments; and
•      (6) loading/applying granulars by hand as spot treatments.

       The calculations of potential total cancer risk to  homeowner handlers indicate that
risks are below l.OE-6 for all  other scenarios.

•      (8) - no PHED data exist for mixing/loading/applying solution as a dip treatment.

Data Quality and Confidence in Assessment.  Several issues  must be considered when
interpreting the homeowner handler risk estimates:
                                     71

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Table 17. Residential Handler Exposures and Short-term and Intermediate-term Inhalation Risks for I
Exposure Scenario (Seen. #)
Baseline Inhalation
Unit Exposure"
(//g/lb ai)
Range of Application
Ratesb (Ib ai/A)
Crop Type or Target0
Amount
Handled per
Day11
prodione ( Baseline)
Baseline
Inhalation
Exposure'
(mg/day)
Short-term
Baseline
Inhalation Dosef
(mg/kg/day)
Int.-term
Baseline Daily
Inhalation Dose8
(mg/kg/day)
Baseline Short-
term MOEh
Baseline hit-
term MOE1
Mixer/Loader/Applicator Risks
Mixing/Loading/Applying Sprays
with a Low Pressure Handwand (1)
Mixing/Loading/Applying Using a
Backpack Sprayer (2)
Mixing/Loading/Applying Using a
Garden Hose-end Sprayer (3)
Loading/ Applying Granulars Using a
Belly Grinder (4)
Loading/ Applying Granulars Using a
Push-type Lawn Spreader (5)
Loading/ Applying Granulars by Hand
as a Spot Treatment (6)
Mixing/Loading/Applying Solution as
a Dip Treatment (8)
30
30
9.5
62
6.3
470
No Data
0.0026 Ib ai/gal
0.01 Ib ai/gal
0.1251bai/l,000ft2
0. 104 Ib ai/gal
0.0026 Ib ai/gal
0.01 Ib ai/gal
0.1251bai/l,000ft2
0. 104 Ib ai/gal
0.0026 Ib ai/gal
0.01 Ib ai/gal
0.1251bai/l,000ft2
0. 104 Ib ai/gal
0.0941 Ib ai/1,000 ft2
0.0941 Ib ai/1,000 ft2
0.0941 Ib ai/1,000 ft2
0.0941 Ib ai/1,000 ft2
0.0941 Ib ai/1,000 ft2
No Data
Fruit/Nut Trees
Ornamentals
Turf
Vegetable/Small Fruit Garden
Fruit/Nut Trees
Ornamentals
Turf
Vegetable/Small Fruit Garden
Trees
Ornamentals
Turf
Vegetable/Small Fruit Garden
Turf
Turf
Turf
Ag
5 gallons
5 gallons
20,000 ft2
5 gallons
5 gallons
5 gallons
20,000 ft2
5 gallons
50 gallons
50 gallons
20,000 ft2
50 gallons
20,000 ft2
1,000 ft2
20,000 ft2
1,000 ft2
1,000 ft2
No Data
0.00039
0.0015
0.075
0.016
0.00039
0.0015
0.075
0.016
0.0012
0.0048
0.024
0.049
0.12
0.0058
0.012
0.00059
0.044
No Data
6.5E-6
2.5E-5
1.3E-3
2.7E-4
6.5E-6
2.5E-5
1.3E-3
2.7E-4
2.0E-5
8.0E-5
4.0E-4
8.2E-4
2.0E-3
9.7E-5
2.0E-4
9.8E-6
7.3E-4
No Data
5.6E-6
2.1E-5
1.1E-3
2.3E-4
5.6E-6
2.1E-5
1.1E-3
2.3E-4
1.7E-5
6.9E-5
3.4E-4
7.0E-4
1.7E-3
8.3E-5
1.7E-4
8.4E-6
6.3E-4
No Data
3,100,000
800,000
15,000
74,000
3,100,000
800,000
15,000
74,000
1,000,000
250,000
50,000
24,000
10,000
210,000
100,000
2,000,000
27,000
No Data
1,100,000
290,000
5,500
27,000
1,100,000
290,000
5,500
27,000
360,000
88,000
18,000
8,700
3,600
73,000
36,000
730,000
9,700
No Data
Footnotes:
a   Baseline Inhalation Unit Exposure values taken from PHED VI. 1 reflect no respiratory protection.
b   Application rates come from values found in the LUIS report and on Iprodione labels. For some scenarios, a range of application rates is used to represent different crops/sites based on application method. Examples of application
    rates and source labels include:0.0026 Ib ai/gal applicable to stone fruit trees - EPA Reg. No. 264-562;
                               0.01 Ib ai/gal ornamentals - EPA Reg. No. 264-563;
                               0.125 Ib ai/1,000 ft turf- EPA Reg. No. 264-562; and
                               0.104 Ib ai/gal potatoes and carrots -  EPA Reg. No. 264-562.
c   Crop Type or Target provides a general description of the intended uses of various products containing Iprodione. Separate categories are presented because of the distinct differences in application rates and acres or gallons treated
    or applied.
d   Amount Handled Per Day values are from the EPA estimates of acreage treated, or volume handled in a single day for each exposure scenario of concern based on the application method.
e   Baseline Inhalation Exposure (mg/day) = Unit Exposure (ug/lb ai) * (1 mg/1000 ug) Conversion * Application Rate (Ib ai/ft2 or Ib ai/gal) * Amount Handled Per Day (ftVday or gallons/day).
f   Baseline Short-term Daily Inhalation Dose = Baseline Daily Inhalation Exposure (mg/day)/Body Weight (60 kg).
g   Baseline Int.-term Daily Inhalation Dose = Baseline Daily Inhalation Exposure (mg/day)/Body Weight (70 kg).
h   Baseline Short-term MOE = NOEL (20 mg/kg/day) / Short-term Baseline Daily Inhalation Dose (mg/kg/day).
I   Baseline Intermediate-term MOE = NOEL (6.1 mg/kg/day) / Intermediate-term Baseline Daily Inhalation Dose (mg/kg/day).
                                                                                                    72

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Table 18. Residential Handlers' Combined Dermal and Inhalation Cancer Risk Assessment for Iprodione (Baseline)
Exposure Scenario (Seen. #)
Baseline
Dermal Unit
Exposure"
(mg/lb ai)
Baseline
Inhalation Unit
Exposure11
(Mg/lb ai)
Range of Application
Ratesc(lb ai/A)
Crop Type or Target11
Amount
Handled per
Day'
Daily
Dermal
Exposure1
(mg/day)
Daily
Inhalation
Exposure8
(mg/day)
Baseline Total
Daily Dose11
(mg/kg/day)
Number of
Exposures
per Year1
Baseline
LADD"
(mg/day)
Baseline
Total Cancer
Riskk
Mixer/Loader/Applicator Risk
Mixing/Loading/Applying Sprays
with a Low Pressure Handwand (1)
Mixing/Loading/Applying Using
a Backpack Sprayer (2)
Mixing/Loading/Applying Using
a Garden Hose-end Sprayer (3)
Loading/ Applying Granulars
Using a Belly Grinder (4)
Loading/ Applying Granulars
Using a Push-type Lawn Spreader
(5)
Loading/ Applying Granulars by
Hand as a Spot Treatment (6)
100
5.1
30
110
3
430
30
30
9.5
62
6.3
470
0.0026 Ib ai/gal
0.01 Ib ai/gal
0.1251bai/l,000ft2
0. 104 Ib ai/gal
0.0026 Ib ai/gal
0.01 Ib ai/gal
0. 125 Ib ai/1,000 ft2
0. 104 Ib ai/gal
0.0026 Ib ai/gal
0.01 Ib ai/gal
0.1251bai/l,000ft2
0. 104 Ib ai/gal
0.0941 Ib ai/1,000 ft2
0.0941 Ib ai/1,000 ft2
0.0941 Ib ai/1,000 ft2
0.0941 Ib ai/1,000 ft2
0.0941 Ib ai/1,000 ft2
Fruit/Nut Trees
Ornamentals
Turf
Vegetable/Small Fruit
Garden
Fruit/Nut Trees
Ornamentals
Turf
Vegetable/
Small Fruit Garden
Trees
Ornamentals
Turf
Vegetable/
Small Fruit Garden
Turf
Turf
Turf
5 gallons
5 gallons
20,000 ft2
5 gallons
5 gallons
5 gallons
20,000 ft2
5 gallons
50 gallons
50 gallons
20,000 ft2
50 gallons
20,000 ft2
1,000 ft2
20,000 ft2
1,000 ft2
1,000 ft2
1.3
5.0
250
52
0.066
0.26
13
2.7
3.9
15
75
160
210
10
5.6
0.28
40
0.00039
0.0015
0.075
0.016
0.00039
0.0015
0.075
0.016
0.0012
0.0048
0.024
0.049
0.12
0.0058
0.012
0.00059
0.044
0.00093
0.0036
0.18
0.037
0.000053
0.00021
0.010
0.0021
0.0028
0.011
0.054
0.11
0.16
0.0073
0.0041
0.00021
0.029
4
4
2
4
4
4
2
4
4
4
2
4
2
2
2
2
2
5.1E-6
2.0E-5
5.2E-4
2.0E-4
2.9E-7
1.2E-6
2.7E-5
1.2E-5
1.6E-5
6.0E-5
1.5E-4
6.0E-4
4.4E-4
2.0E-5
1.1E-5
5.8E-7
7.9E-5
2.2E-7
8.8E-7
2.3E-5
8.8E-6
1.3E-8
5.3E-8
1.2E-6
5.3E-7
7.0E-7
2.6E-6
6.6E-6
2.6E-5
1.9E-5
8.8E-7
4.8E-7
2.5E-8
3.5E-6
FOOTNOTES
   a   Baseline PHED VI. 1 Dermal Unit Exposure values represent short pants, short sleeved shirt, no gloves, and open mixing/loading, (see Exposure Scenario Descriptions Table for further information).
   b   Baseline PHED VI. 1 Inhalation Unit Exposure values reflect no respiratory protection.
   c   Application rates come from values found in the LUIS report and on Iprodione labels. For some scenarios, a range of application rates is used to represent different crops/sites based on application method. Examples of application
       rates and source labels include:
                    0.0026 Ib ai/gal applicable to stone fruit trees - EPA Reg. No. 264-562;
                    0.01 Ib ai/gal on ornamentals - EPA Reg. No. 264-563;
                    0.125 Ib ai/1,000 ft2 on turf - EPAReg. No. 264-562; and
                    0.104 Ib ai/gal on potatoes and carrots - EPA Reg. No. 264-562.
   d   Crop Type or Target provides a general description of the intended uses of various products containing Iprodione.  Separate categories are presented because of the distinct differences in application rates and acres treated.
   e   Amount Handled Per Day values are from the EPA estimates of acreage treated, or volume handled in a single day for each exposure scenario of concern based on the application method.
   f   Daily Dermal Exposure (mg/day) = Unit Exposure (mg/lb ai) * Application Rate (Ib ai/ft2 or Ib ai/gal) * Amount Handled Per Day (ftVday or gallons/day).
   g   Daily Inhalation Exposure (mg/day) = Unit Exposure (ug/lb ai) * (1 mg/1000 ug) Conversion * Application Rate (Ib ai/ft2 or Ib ai/gal) * Amount Handled Per Day (ftVday or gallons/day).
   h   Baseline Total Daily Dose = [Baseline Daily Dermal Exposure (mg/day) * 0.05 (Dermal Absorption Factor) + Baseline Daily Inhalation Exposure (mg/day)]/Body Weight (70 kg).
   I   Number of Exposures Per Year is based on maximum number of applications which represent private use.
   j   Baseline LADD (mg/kg/day) = Baseline Total Daily Dose (mg/kg/day) * (Number of days exposure per year/365 days per year) * 35 years applied/70 year lifetime.
   k   Baseline Total Cancer Risk = Baseline LADD (mg/kg/day) * (Q/),  where Q/ = 4.39E-2 (mg/kg/day).
                                                                                                  73

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•      The PHED surrogate data for the garden hose-end sprayer scenario, application with
       a backpack sprayer scenario, application with a push type granular spreader scenario,
       and application with low pressure handwand scenario are low confidence due to low
       number of replicates and/or low quality data.

•      The PHED values for loading/applying granulars by  hand are based on gloved hand
       data; a 90% PF was used to estimate bare hand exposure for the baseline scenario.

•      Factors used to calculate daily exposures to handlers  (e.g., square footage treated per
       day or gallons of liquid applied)  are based on labeling directions and professional
       judgement due to a lack specific usage data.

•      The PHED values for low pressure handwand, backpack sprayer and garden hose-end
       sprayer are representative for treatment of low- to mid-level shrubs.  The exposure
       data for these scenarios may underestimate exposures to head and upper body when
       homeowners make applications to trees.

                     (1)    Non-Occupational Postapplication Exposures and Risks

       Once  sprays  and dusts have settled,  Postapplication inhalation  exposure is not
expected to be significant. In addition,  an appropriate dermal endpoint was not available for
use in assessing non-cancer dermal risks. Consequently, only postapplication cancer risks
have been assessed.

       Postapplication Exposure Scenarios. EPA has determined that there are crop groups
and activities likely to result in non-occupational Postapplication exposures from iprodione.
These crop groups/activities were grouped based on  the  assumed exposure level, PHI,
maximum number of applications per  season and expected frequency of exposure. These crop
groups/activities include the following:

•      Grape harvesting, pruning, and staking: assumed to  result in higher exposures than
       other activities such as propping or staking which would have a longer PHI and lower
       number of days of exposure;
•      Harvesting small vegetables and fruits, including strawberries: assumed to result in
       higher exposures than activities such as scouting, thinning,  or weeding , which have
       longer PHIs and lower exposure frequencies;
•      Ornamental shrub, vine and flowering or foliage plant transplanting, pruning, cutting,
       and bundling: assumed to have  high exposure levels and high exposure frequencies,
       and with greater application rates than those applied to fruits and vegetables;
•      Dermal exposure from residue on turf (adult and child);
•      Incidental  nondietary ingestion of residue on turf resulting  from hand-to-mouth
       transfer (toddler);
•      Ingestion of treated turfgrass (toddler); and
•      Incidental  ingestion of soil from treated areas (toddler).

                                    74

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               Although  youths,  in  addition  to adults  and  toddlers,  may  also  engage in
       Postapplication activities, they are expected to have lower transfer coefficients than adults
       (i.e., 5,000 cm2/hour for harvesting fruit from trees as opposed to an adult value of 10,000
       cm2/hour)6,  and lower body weights (i.e., 39 kg  as opposed to 70 kg for adults).  The
       proportionally lower values for Tc and body weight would result in similar exposure values
       for youths and adults. For  this reason,  a separate assessment for youths has  not been
       performed.  The exposure assessment for adults (LADD) would also apply to youths.

               Although it is likely that toddlers would be exposed to iprodione from dermal contact
       with, and incidental ingestion of grass, soil, or hand-to-mouth transfer, no risk assessment was
       performed for these scenarios because no  relevant oral toxicological endpoints have been
       identified. The acute  dietary endpoint of 20 mg/kg/day for iprodione is applied only to females
       13+.  At present, EPA has no toxicological data to elucidate the  effects of iprodione on
       toddlers. In addition, toddler cancer risks have not been quantified due to the fact that EPA
       currently has no appropriate means to account for changing exposure parameters (i.e., activity
       duration, body weight, surface  area, and transfer coefficient) as the toddler progresses
       through various age groups.

               The residential post-application scenarios and assumptions for iprodione are outlined
       in Table 19.

Table 19. Residential Postapplication Scenarios and Assumptions for Iprodione
Exposure Activity/
Crop or Target
Grapes
(Harvesting/Pruning/Staking)
Small Vegetables and Fruits,
including Strawberries
(Harvesting/Weeding/Staking)
Ornamentals
(Transplanting/Pruning /
Bundling Flowers)
Adults (Dermal Contact with
Turf)
Applicati
on Rate
(Ib
ai/acre)
0.75
0.75
3
3
Contact Rate
(cnvVhr)"
10,000
3,500
7,000
1,000
Exposure
Days per
Yearb
8
24
4
40
Years of
Exposure
35
35
35
35
Hours
Exposed
per Day'
0.67
0.67
0.67
1
Maximum Number
of Applications per
Season0
4
2-10
NS
2
Application
Interval0
(days)
7
7-14
7-14
NA
FOOTNOTES
NA = Not applicable. NS = Not specified on Iprodione label.
a      Values come from SOP s for Residential Exposure Assessments6, except for the turf scenario, which is based on professional judgement (i.e.,
       a contact rate of 1,000 cmVhr is more representative for a lifetime of exposure, and 1 hour/day represents the 50th percentile for time spent
       playing in grass in Exposure Factors Handbook, 1997).
b      Exposure days per year are based on Iprodione label directions and professional judgment. Turf exposure = 26 weeks x 1-2 days/wk.
c      Values derived from Iprodione labels for agricultural scenarios. Professional judgment employed in assumption of 2 turf applications per
       growing season..


               Data Sources for Scenarios Considered. No chemical-specific Postapplication human
       reentry or transferable residue data were submitted. In lieu of these data,  a Postapplication
       exposure assessment was conducted using the Residential SOPs to determine potential risks
       for the representative scenarios.
                                               75

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       Assumptions Used in Postapplication Exposure  Calculations (Cancer  Risks).
Assumptions used  in the calculations for residential  Postapplication risks include the
following:

•      The cancer risks were assessed for the same day that application was assumed to
       occur; it is not feasible to set REIs for homeowners.

•      A dermal absorption value of 5% was used in this assessment.

•      The exposure duration for adults was assumed to be 35 years.

•      Transfer coefficients were estimated to be 10,000 cm2/hr for high-contact harvesting
       (i.e., grapes); 7,000 cm2/hr for high contact activities involving ornamental shrubs,
       vines, flowering and foliage plants; and 3,500 cm2/hr for harvesting small fruits and
       vegetables, including strawberries.  The dermal transfer coefficient for low-contact
       turf exposure is estimated to be 1,000 cm2/hr for adults.

•      An average application rate of 3 Ib ai/acre was used in the turfgrass and ornamental
       scenarios (range =1.4  Ib ai/acre and 5.5 Ib  ai/acre).  An average application rate of
       0.75 Ib ai/acre was used for the agricultural crop  scenarios (i.e., harvesting of grapes
       and small fruits and vegetables), and was calculated from the application range of 0.5
       to 1.0 Ib ai/acre).   The residential application rates used  in the handler assessment
       were assessed in units of Ib ai/gallon, due to application methods. These same rates
       were converted to Ib ai/acre here, in order to calculate Postapplication risks.

•      On the day of application, it was assumed that 20 percent  of the application rate was
       available as dislodgeable residue, because actual DFR data are not currently available,
       and assuming a 20 percent initial dislodgeable residue may be an over-estimation,
       DFRs were also derived from an initial 10 percent and 5  percent fo the application
       rate.

•      Adults were assumed to weigh 70 kg.

•      The duration of exposure was assumed to be 0.67 hours per day, except for the turf
       scenario, which has an assumed duration of 1 hour per day.

                     (2)     Postapplication Exposure and Non-Cancer Risk Estimates

No non-occupational crop groups or activities  were identified as having potential  chronic
exposure.
                                     76

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                             (3)     Postapplication Exposure and Risk Estimates for Cancer

               Non-occupational Postapplication scenarios were assessed for cancer risk; the results
       are summarized in Table 20.  Total cancer risk calculations for the dermal scenarios were
       made using the formulas for DFR, LADD, and risk presented previously in the occupational
       Postapplication discussion.

               As stated previously, toddler cancer risks have not been quantified due to the fact that
       EPA currently has no appropriate means to account for the changing exposure parameters as
       the toddler progresses through the various age groups.

Table 20. Residential Postapplication Cancer Risks from Iprodione
Exposure Activity /Crop or Target
Grapes
(Harvesting/Pruning/Staking)
Small Vegetables and Fruits,
including Strawberries
(Harvesting/Weeding/Staking)
Ornamentals (Transplanting/
Pruning/ Bundling Flowers)
Adults (Dermal Contact with Turf)
20 % Initial Dislodgeable Residues
DFR"
(^g/cm2)
1.7
1.7
6.7
6.7
LADDb
(mg/kg/day)
8.8E-05
9.3E-05
1.2E-04
2.6E-04
Cancer
Risk0
3.9E-06
4.1E-06
5.4E-06
1.2E-05
10 % Initial Dislodgeable Residues
DFR"
(//g/cm2)
0.84
0.84
3.4
3.4
LADDb
(mg/kg/day)
4.4E-05
4.6E-05
6.2E-05
1.3E-04
Cancer
Risk0
1.9E-06
2.0E-06
2.7E-06
5.8E-06
5 % Initial Dislodgeable Residues
DFR"
(//g/cm2)
0.42
0.42
1.7
1.7
LADDb
(mg/kg/day)
2.2E-05
2.3E-05
3.1E-05
6.6E-05
Cancer
Risk0
9.7E-07
l.OE-06
1.4E-06
2.9E-06
FOOTNOTES
a      DFR values derived from surrogate data. Surrogate DFR (//g/cm2) = Application rate (Ib ai/acre) x Conversion factor (,ug/cm2/lb ai/acre) x
       fraction of active ingredient retained on foliage. Fraction = 0.2, 0.1, and 0.05 for day zero.
b      LADD = [DFR (//g/cm2) x Tc (cmVhr) x mg/1,000 /j,g x hours exposed/day x exposure days/year x years of exposure x dermal absorption
       factor] / [70 kg x 70 yr x 365 days/yr], where the DFR value is assumed to stay constant over time for the days exposed (no actual DFR values
       available for multiple applications over time).
c      Cancer Risk = LADD (mg/kg/day) x Ql* (mg/kg/day), where Ql* = 4.39E-2.

                             (4)     Summary of  Postapplication Risks, Data  Gaps, and
                                     Confidence

               Non-occupationalpostapplication scenarios with risk concerns.  The results of the
       non-occupational Postapplication cancer  risk  assessment indicate that all residential
       Postapplication scenarios have risks greater than  l.OE-6.

               Data gaps and uncertainties. The following data gaps or uncertainties were associated
       with this  assessment:

       •       No chemical-specific exposure or transferable residue data were submitted.  As a
               result, all analyses were completed using surrogate data from sources such as PHED
               and assumptions related to the behavior and environmental fate of the chemical in the
               environment (e.g., dissipation of transferable residues). Typically, these assumptions
               are considered to yield conservative estimates. However, because iprodione degrades
               at a slow rate, the results of this assessment are expected  to be somewhat less
               conservative than would be expected for other chemicals.
                                               77

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•      Factors used to  calculate Postapplication risks (e.g., hours exposure per  day or
       average reentry day) are based on label directions and professional judgment due to
       an absence of specific usage data for each scenario.

•      Crop groupings for the Postapplication assessment are assumed to be representative
       of general ranges of exposure,  and are based on application rate, PHI, exposure
       activity and exposure duration.  Risks are expected to vary within these crops
       groupings.

              g.      Incident Reports

       The following data bases have been consulted for the poisoning incident data on the
active ingredient iprodione:

       OPP Incident Data System (IDS) - reports of incidents from various sources,
including registrants, other federal and state health and environmental agencies and individual
consumers, submitted to OPP since 1992.  Reports submitted to the Incident Data System
represent  anecdotal reports  or allegations only, unless otherwise stated.   Typically no
conclusions can be drawn implicating the pesticide as a cause of any of the reported health
effects.  Nevertheless, sometimes with enough cases and/or enough documentation risk
mitigation measures may be suggested.

       Poison Control Centers - as the result of Data-Call-ins issued in 1993, OPP received
Poison Control Center data covering the years 1985 through 1992 for 28 organophosphate
and carbamate chemicals.  Most of the national Poison Control Centers (PCCs) participate
in a national data collection system, the Toxic Exposure Surveillance System which obtains
data from about 70 centers at hospitals and universities. PCCs provide telephone consultation
for individuals and health care providers on suspected poisonings, involving drugs, household
products, pesticides, etc.

       California Department of Food and Agriculture (replaced by the Department of
Pesticide Regulation in 1991) - California has collected uniform data on suspected pesticide
poisonings since 1982.  Physicians are  required,  by  statute, to report to their local health
officer all occurrences of illness suspected of being related to exposure to pesticides. The
majority of the incidents involve workers.  Information on exposure (worker activity), type
of illness (systemic, eye, skin, eye/skin and respiratory),  likelihood of a causal relationship,
and number of days off work and in the hospital are provided.

       National Pesticide Telecommunications Network (NPTN) - NPTN is a toll-free
information service supported by OPP. A ranking of the top 200 active ingredients for which
telephone calls were received during calendar years 1984-1991, inclusive has been prepared.
The total number of calls was tabulated for the categories human incidents, animal incidents,
calls for information, and others.
                                     78

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                     Incident Data System

       Please note that the following cases  from the IDS  do not have documentation
confirming exposure or health effects unless otherwise noted.

       A pesticide incident occurred in 1994, when a UPS driver was exposed to iprodione
after a bag spilled in his truck and he experienced dizziness. No further information on the
disposition of the case was reported.

       A pesticide incident occurred in 1995, when a male was sprayed with an aqueous use
dilution mixture of iprodione after the rupture of a gauge. He experienced numb lips and
tongue, tingling fingers, and headache. No further information on the disposition of the case
was reported.

       A pesticide incident occurred in 1994, when a male was exposed to spray droplets on
his face and neck after his garden was sprayed with iprodione.  Specific symptoms were not
mentioned. No further information on the disposition of the case was reported.

       A pesticide incident occurred in  1994, when individuals alleged they developed skin
rashes while working  in their garden three days after iprodione and other pesticides were
sprayed on crop fields. No further information on the disposition of the case was reported.

       A pesticide incident occurred in 1996, when two workers prepared nonflowering
ornamentals for shipment less than one day after foliar application of iprodione and another
pesticide. The products were applied at 1 Ib and 3 lbs/100 gallons water. The workers wore
rubber gloves to wrap loose vines around the main plants and developed a rash on their arms
above the glove line the next day. No further information on the disposition of the case was
reported.

                     California Data - 1982 through 1990

       Detailed  descriptions of 120 cases  submitted to the California Pesticide  Illness
Surveillance Program (1982-1995) were reviewed. In 26 of these cases, iprodione was  used
alone and was judged to be responsible for the health effects.  Only cases with a definite,
probable or possible relationship were reviewed.  Iprodione ranked 84th as a cause of
systemic poisoning in California. Table 21 below presents the types of illnesses reported by
year.  None of the cases reported in the table below were reported to have been hospitalized.
Table 22 gives the total number of workers that took time off work as a result of their illness.
                                     79

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Table 21. Cases Due to Iprodione Exposure in California Reported by Type of Illness and Year, 1982-1995.
Year
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
Total
Illness Type
bSystemic
-
-
-
-
1
1
-
1
-
1
-
-
4
-
8.00
Eye
-
-
-
-
1
-
-
1
1
1
-
-
1
-
5.00
Skin
-
-
2
-
-
1
-
-
4
1
-
1
2
1
12.00
Respir.
-
-
-
-
-
-
-
-
-
-
-
-
-
-
0.00
cComb.
-
-
-
-
-
-
-
-
-
1
-
-
-
-
1.00
Total
-
-
2
-
2
2
-
2
5
4
-
1
7
1
26.00
b Category includes cases where skin, eye, or respiratory effects were also reported
0 Category includes eye/skin illness

Table 22. Number of Persons Disabled (taking time off work) or Hospitalized for Indicated Number of Days
After Iprodione Exposure in California, 1982-1995.
Duration
One day
Two days
3-5 days
5-10 days
more than 10 days
unknown
Number of Persons Disabled
2
1
2
-
-
-
Number of Persons Hospitalized
-
-
-
-
-
-
               A total of 12 persons had skin illnesses or 46% of 26 persons.  Four of these cases
       occurred in 1990.  A total of 8 persons had systemic illnesses or 31% of 26 persons.  A
       variety of worker activities were associated with exposure to iprodione as illustrated in table
       23 below.
                                               80

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Table 23. Illnesses by Activity Categories for Iprodione Exposure in California, 1982-1995
Activity Category
Coincidental
Applicator
Resifield
Other
Mixloader
Driftexp
Clean/Fix
Pack/Proc
Total
Illness Category
bSystemic
-
3
3
1
-
1
-
-
8.00
Eye
-
-
1
1
2
-
1
-
5.00
Skin
1
4
6
-
-
-
-
1
12.00
Respiratory
-
-
-
-
-
-
-
-
0.00
GCombinatio
n
-
-
-
-
1
-
-
-
1.00
Total
1
7
10
2
3
1
1
1
26.00
a Mixloader = mixer and/or loader; Driftexp = exposure to pesticide that has drifted from intended targets;
Clean/Fix = cleaning and/or repairing pesticide contaminated equipment; Pack/Proc = packing, processing, or retailing commodities
b Category includes cases where skin, eye, or respiratory effects were also reported
c Category includes eye/skin illness

              According to the above activity categories, resifield (field worker exposed to residue
       in the field) that affected the skin were associated with the majority of the exposures.  The
       skin illnesses occurred after iprodione was applied  to citrus and golf course greens and
       workers developed itchy rashes on hands, arms, face and legs. The resifield systemic illnesses
       included symptoms of headache and nausea.  The  ground applicator  systemic  illnesses
       included symptoms of weakness, eye irritation, muscle weakness to exposed side efface, and
       rashes on hands, neck, and face.

              A pesticide incident occurred in 1996 that involved a male strawberry picker that was
       a harvester and did not have duties that involved handling any pesticides. Examination of the
       records for the fields in which he worked for 3 months prior to his illness showed  potential
       exposure to 10 different pesticides, including iprodione.  He experienced flu-like symptoms
       and developed tonsillitis, coughing,  and nosebleeds and was hospitalized for eight  days and
       was diagnosed with pancytopenia. None of the other members of his crew, which had the
       same exposures, displayed these symptoms.

                            National Pesticide Telecommunication Network (NPTN)

              On the list of the top 200 chemicals for which NPTN received calls from 1984-1991
       inclusively, iprodione was reported to be involved in sixteen human incidents.

              Summary/Conclusions:  Exposure to iprodione can lead to skin illness requiring
       medical care.  Skin rashes have been reported in field workers exposed to residues  of
       iprodione.   A few cases (8) have reported relatively minor systemic symptoms such  as
       headache, nausea, and dizziness.  Three of the eight cases were reportedly due to field
       reentry. However, in none of the systemic cases was the exposure considered a probable or
       definite cause of the effects.
                                             81

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              h.     Dietary Exposure and Risk Assessment/Characterization

                    (1)    Dietary Exposures from Food Sources

                           (a)    GLN 860.1200:  Directions for Use

       EPA examined the registered food/feed use patterns and reevaluated the available
residue chemistry database for adequacy in supporting these use patterns. A comprehensive
summary of iprodione food/feed use patterns, based on the product labels registered to
Rhone-Poulenc is presented in Table 24.  Label amendments are required to  support
continued uses of iprodione on several crops. Details of the required label amendments are
presented in the endnotes for GLN 860.1200 (Directions for Use) of appendix IV, Table D.

       The Agency classifies the registered Section 24(c) uses of iprodione on clover (seed
crop;  SLNs OR960011 and OR960012) and on peas (seed treatment;  SLNs WA930026,
WA930027) to be non-food uses because of adequate regulatory state controls and label use
restrictions.

       The status of reregistration requirements for each guideline topic is based on the use
patterns registered by the basic producer.  EPA will require that all end-use product labels
(e.g., MAI labels, SLNs, and products subject to the generic data exemption) be amended
such that they are consistent with the basic producer labels and with the use changes required
in this RED.

                           (b)    GLN 860.1300: Nature of the Residue - Plants

       The reregistration requirements for plant metabolism are fulfilled.  Acceptable studies
depicting the qualitative nature of the residue in three dissimilar crops (peaches, peanuts, and
rice) have been submitted and evaluated. Residues comprising the current iprodione tolerance
expression for plants accounted for 95% of the total radioactive residues (TRR) in peaches,
78% of the TRR in peanut hay, 75% of the TRR in rice head/stalks, and  60% of the TRR in
rice straw. Other metabolites in each crop individually represented less than 10% TRR and/or
less than 0.05 ppm. The residues to be regulated in plants should continue to be the parent,
its isomer RP-30228,  and metabolite RP-32490, which comprise the current tolerance
expression for plants.

                           (c)    GLN 860.1300: Nature of the Residue - Animals

       The reregistration requirements for livestock metabolism are fulfilled provided label
restrictions are in place.  An additional ruminant metabolism study will not be required,
provided that all applicable iprodione end-use product labels prohibit use on cowpeas and
prohibit the feeding of iprodione-treated peanut hay to livestock animals, and that the Ix
feeding level (theoretical maximum dietary intake) based on tolerances for feed items  does
not significantly increase above 30 ppm. If any registrant desires to support use on cowpeas

                                    82

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or the feeding of peanut hay, or if new uses would significantly increase the Ix feeding level
above 30 ppm, then a new ruminant metabolism study would be required to identify residues
of concern and to generate samples for radiovalidation of an enforcement analytical method.
An additional poultry metabolism study is not required.

       The residues to be regulated in livestock should continue to be the parent, its isomer
RP-30228, and metabolites RP-32490 and RP-36114 which comprise the current tolerance
expression for livestock commodities.

                           (d)    GLN 860.1340: Residue Analytical Methods

       Methods for determination  of residues in/on plant commodities:  The Pesticide
Analytical Manual (PAM) Vol. II lists a GLC/ECD method, designated as Method I, for the
determination of iprodione residues of concern in/on plant commodities. Method I does not
use benzene as  a reagent and detects residues of iprodione parent, iprodione isomer RP-
30228, and iprodione metabolite RP-32490 as individual peaks on GLC.   A successful
Agency validation of Method I was carried out with kiwifruit.

       The Chemistry Branch has determined that the proposed Common Moiety Method,
wherein iprodione tolerance residues are all hydrolyzed to dichloroaniline, is less suitable for
enforcement than Method I of PAM Vol. II because of the potential for interference and a
much longer time required  for  analysis.  Other chemicals that can be converted to the
dichloroaniline moiety will be assumed to interfere with  detection of iprodione residues,
unless the registrant can provide data demonstrating otherwise.  The Common  Moiety
Method, therefore, will not be forwarded to FDA for publication at this time.

       The Common Moiety Method is, however, suitable for data  collection provided it is
modified to  incorporate comments from  Agency reviews and  method validation.   The
Chemistry Branch notes that additional data are required for confined rotational crops, and
the  iprodione residues of concern in/on rotational crops have not yet been determined.
Because  of the  presence of conjugates not fully identified, the Common Moiety Method
described may ultimately prove the most appropriate method available for determining
iprodione residues of concern in/on rotational crops.

       The iprodione Phase 4 review waived the requirements for radiovalidation data for the
analytical methods for plants since the parent and regulated metabolites are not likely to be
bound or conjugated.

      Methods for determination  of residues in/on livestock  commodities:   There are
presently no methods published in PAM Vol. II for the enforcement of iprodione tolerances
for livestock commodities. Morse Laboratories SOP Method-71 has been proposed  as an
enforcement method for the determination of non-hydroxylated iprodione residues; this
method converts non-hydroxylated iprodione residues to dichloroaniline as a common moiety.
For the purposes of reregi strati on, Method-71 should be amended in accordance with the

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recommendations of the laboratory which conducted the independent laboratory validation.
Because Method-71 uses benzene as a reagent, the registrant should justify the use of this
substance, including an explanation of how substitution of a different solvent affects results.

       The registrant should additionally provide independent laboratory validation data for
the proposed method for determining hydroxylated iprodione residues (e.g., RP-36114) in
ruminant milk and tissues. Consistent with iprodione phase 4 review, the registrant should
explain why use of benzene and diazomethane as reagents is necessary.

       Finally, the registrant should provide and/or develop confirmatory method(s) for the
determination of major iprodione residues (parent iprodione and metabolites RP-32490 and
RP-36114) in livestock commodities.  This requirement is based on the fact that the proposed
methods  each involve conversion of iprodione residues of concern  to dichloroaniline;
therefore, there is a concern for interference from other  pesticides.  If such confirmatory
method(s) can be  successfully developed and independently validated, then EPA will submit
them  directly  for Agency validation, rather than either  of the common moiety methods
currently proposed for livestock commodities.

                            (e)     GLN 860.1360: Multiresidue Methods

       The registrant has submitted  data on the determination of residues of iprodione,
iprodione isomer RP-30228, iprodione metabolite RP-32490, and iprodione metabolite RP-
36114 using FDA multiresidue methods.  These data have  been forwarded to FDA. Pending
notification from  FDA that further data are necessary, the reregi strati on requirements for
multiresidue method testing are satisfied for  all iprodione residues in current plant and
livestock tolerance expressions.

       The 1/94 FDA PESTDATA database (PAM Volume I, Appendix I) indicates that
iprodione and iprodione metabolite isomer are completely recovered (>80%) by Multiresidue
Methods Section  302 (Luke method; Protocol D), and that recovery is small (<50%) using
Multiresidue Methods Section 303 (Mills, Onley, Gaither method; Protocol E, non-fatty
foods). Iprodione is not recovered using Section 304 (Mills method; Protocol E, fatty foods).

                            (f)     GLN 860.1380: Storage Stability Data

       The reregi strati on requirements for storage stability data on plant commodity matrices
are fulfilled.   The data indicate that  residues of iprodione,  its isomer RP-30228, and  its
metabolite RP-32490 are  stable  under frozen storage conditions for 24  to 34 months in/on
representative raw agricultural commodities of oilseeds, non-oily grains, leafy vegetables, root
crops, and fruit and fruiting vegetables. No significant decline of residues was observed over
the duration of study.  These data validate the storage conditions and intervals of samples
from the  submitted field trials. The reregi strati on requirements for storage stability data on
livestock commodity matrices are also fulfilled. The data submitted provide guidance for
storage parameters to be used with future studies. Future magnitude of residue studies should
be supported by concurrent storage stability data.

                                     84

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                            (g)    GLN 860.1500: Crop Field Trials

       Pending required label amendments for some crops, the reregi strati on requirements
for magnitude of the residue in/on the following raw agricultural commodities (RACs) are
fulfilled:  almonds (nutmeat and hulls); apricots; beans (dry and succulent); blueberries;
boysenberries, broccoli; caneberries; carrots; cherries; currants; garlic; ginseng (dried root);
grapes; kiwifruit; lettuce (head and leaf); mustard (Chinese); nectarines; onions (dry bulb);
peaches;  peanuts (nutmeat and hay); plums (fresh prunes); potatoes;  raspberries;  rice;
strawberries.   Overall, adequate  field  trial  data depicting iprodione tolerance residues
following treatments according to the maximum registered use patterns have been submitted
for the RACs listed above or have been translated where appropriate.  Label revisions are
required  for some  crops in order to reflect current Agency policies and/or to reflect the
parameters of use patterns for which field trial data are available. Details of the required label
amendments are presented in the endnotes for GLN 860.1200 (Directions for Use) of Table
B. Refer to "Tolerance Reassessment Summary" section for recommendations with respect
to established tolerance levels. The temporary tolerances for tangelos and tangerines, and the
time-limited tolerance for cottonseed have expired; therefore, they are not considered in this
document.

                            (h)    GLN 860.1520: Processed Food/Feed

       The reregi strati on  requirements for  magnitude of the residue  in  the  processed
commodities of grapes, peanuts, plums, potatoes, and rice are fulfilled.  Iprodione tolerance
residues do not concentrate in the processed commodities of peanuts and potatoes. Iprodione
tolerance residues concentrate during  rice processing,  and current  tolerances for rice
processed commodities are appropriate.  Iprodione tolerance residues concentrate in raisins
and prunes, and EPA has recommended tolerance levels for these commodities. Refer to
"Tolerance Reassessment Summary" section for recommendations with respect to established
tolerance levels.

       An  acceptable cottonseed processing  study was also submitted and evaluated in
conjunction with the establishment of a time-limited tolerance for cottonseed. The previously
requested bean processing data are no longer necessary since the Agency has determined that
bean cannery residue is not a significant livestock feed item and has been removed from Table
1 (OPPTS GLN 860.1000).

                            (i)     GLN 860.1480: Meat, Milk, Poultry, and Eggs

       The reregi strati on requirements for magnitude of the residue in livestock are fulfilled.
Acceptable ruminant and  poultry feeding studies depicting the magnitude of iprodione
residues  of concern have been  submitted  and evaluated.   Ruminant  feeding data are
acceptable, up to a 1 OX feeding level of 200 ppm. A poultry feeding study was acceptable,
up to a 10X feeding level of 100 ppm.  Data from  these feeding  studies will be used to
reassess the adequacy of the established tolerances for livestock commodities.  As  noted

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above, analytical method, livestock remains an outstanding data requirement. Depending on
the development of an acceptable enforcement method to determine individual residues rather
than common moieties, it may be necessary to adjust tolerance expressions and levels to
reflect the residues detected by analytical enforcement method(s).

                            (j)    GLN 860.1400: Water, Fish, and Irrigated Crops

       Phase 4 Review noted that label directions prohibit aquiculture in treated rice fields,
and data on fish were not required.  If this restriction is removed from the label, then fish
studies would be necessary.  Phase 4 Review also noted that data on residue decline in water
were required for rice, and the registrant had made a commitment to conduct such a study.
This requirement remains an outstanding data gap.

                            (k)    GLN 860.1460: Food Handling

       Iprodione is  presently not registered for  use  in  food-handling  establishments;
therefore, no residue chemistry data are required under this guideline topic.

                            (1)    GLN   860.1850:  Confined   Accumulation   in
                                  Rotational Crops

       Additional data are required before reregi strati on requirements for confined rotational
crops can be considered fulfilled; data are required on the base hydrolysis of standards. The
submitted field rotational study tentatively identified the parent iprodione, its isomer (RP-
30228), and metabolites RP-25040 and RP-44247 as the major radioactive residues in/on
rotational crop commodities.  The metabolites RP-25040 and RP-44247 are not included in
the tolerance expression for primary crops. After resolution of this issue, study results will
likely be presented to the EPA Metabolism Committee.  Depending on whether or not
additional rotational crop metabolites need to be regulated, additional  field rotational crop
data (GLN 860.1900) may be required.

                            (m)   GLN 860.1900: Field Accumulation in  Rotational
                                  Crops

       As noted above, determination of the nature of the residue in confined rotational crops
and a  decision by the EPA Metabolism Committee on the residues to be regulated in
rotational crops are necessary before the Agency can advise the registrant on the residue data
required for extensive field trials.
                                      86

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Table 24.  Food/Feed Use Patterns Subject to Reregistration for Iprodione
Site
Application Timing
Application Type
Application
Equipment
Formulation
[EPA Reg. No.]
Maximum
Single
Application
Rate (ai)
Maximum
Number of
Applications
Per Season
Maximum
Seasonal
Rate (ai)
Preharvest
Interval
(Days)
Use Limitations '• 2- 3
Almonds
Foliar
Ground/aerial
50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482]
4 Ib/gal SC/L [264-562] 4
0.5 Ib/A
4
2.0 Ib/A
35 days after
petal fall
Applications may be made in a minimum of 20 (ground) or 1 5 (aerial) gallons of
water/A. Initial application should be made at pink bud stage and/or if
conditions favorable for disease development persist. Three additional
applications may be made at full bloom, petal fall, and up to 5 weeks after petal
fall.
Apricots (See "Stone Fruits")
Beans (Dry, Lima, and Snap)
Foliar
Ground/aerial
50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482]
4 Ib/gal SC/L [264-562]
l.Olb/A
2
2.0 Ib/A
14
(preforaging
interval) or
45
(prefeeding
interval for
dry bean hay)
Applications may be made in a minimum of 40 (ground) or 10 (aerial) gallons of
water/A. Initial application should be made at first bloom to when 10% of the
plants have one open bloom. The second application may be made 5 to 7 days
later or up to peak bloom. The feeding of snap or succulent bean hay to livestock
is prohibited. Use on cowpeas is prohibited.
Blackberries (See "Caneberries")
Blueberries (See "Bushberries")
Brassica (Cole) Leafy Vegetables (Seed Crop Only)
Foliar
Ground/aerial

50%WP[OR810055],
[WAS 10052],
[AZ880001]
4 Ib/gal F1C [AZ880001],
[OR960032],
[WA960027]
50% WP
[CA850035]
2.0 Ib/A
l.Olb/A
3
(Implied)
5
6.0 Ib/A
(Implied)
5.0 Ib/A
Not specified
(NS)
NS
Use limited to Brassica vegetables (broccoli, Brussels sprouts, cabbage,
cauliflower, kale, kohlrabi, radish, rape, rutabaga, and turnips) grown for seed in
AZ, CA, OR, and WA. In furrow treatment.
Use limited to Brassica vegetables (broccoli, Brussels sprouts, cabbage,
cauliflower, kale, kohlrabi, radish, rape, rutabaga, and turnips) grown for seed in
AZ, CA, OR, and WA. Applications may be made in a minimum of 20 (ground)
or 10 (aerial) gallons of water/A. Application should be made at full bloom, at
pod set, and just prior to harvest. Use of treated crops, debris, or screenings for
food or feed and the grazing of livestock on treated areas are prohibited.


Broccoli
Foliar
Ground
50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482]
4 Ib/gal SC/L [264-562]
l.Olb/A
2
2.0 Ib/A
0
Applications may be made in a minimum of 40 gallons of water/A. Initial
application should be made after thinning (2- to 4-leaf stage) as a directed spray
to the base of the plant and the adjacent soil surface. The second application
may be made up to the day of harvest.
Bushberries (Including Blueberries, Highbush and Lowbush; Currants; Elderberries; Gooseberries; and Huckleberries)
                                                                       87

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Site
Application Timing
Application Type
Application
Equipment
Foliar
Ground

Formulation
[EPA Reg. No.]

50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482]

Single
Application
Rate (ai)

l.Olb/A

Number of
Applications
Per Season

4

Maximum
Seasonal
Rate (ai)

4.0 Ib/A

Preharvest
Interval
(Days)

0

Use Limitations '• 2- 3

Applications may be made in a minimum of 100 gallons of water/A. Initial
application should be made at early bloom (5 to 10% bloom) and again at full
bloom. Two additional applications may be made at 14-day intervals.
Caneberries (Including Blackberries, Loganberries, Red and Black Raspberries, and Cultivars and/or Hybrids)





50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482]
4 Ib/gal SC/L [264-562]


l.Olb/A




4




4.0 Ib/A




0



Applications may be made in a minimum of 100 gallons of water/A. Initial
application should be made at early bloom (5 to 10% bloom) and again at full
bloom. Two additional applications may be made at 14-day intervals.

Carrots


Ground/aerial


50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482]
4 Ib/gal SC/L [264-562]

l.Olb/A or
0 5 Ib/A

mixed with

fungicides)
4
or
10
(tank mix
rate)

4.0 Ib/A
or
5.0 Ib/A
(tank mix
rate)



0



Applications may be made in a minimum of 10 gallons of water/A. Initial
application should be made when conditions become favorable for disease
development. Additional applications may be made at 7- to 14-day intervals.


Carrots (continued)
Seed soak
Ground
50%WP[WA940001]
4 Ib/gal F1C [WA940006]
0.25 lb/6
gal
1

0 25/6 gal

I

Use limited to seed treatment of carrots in WA. Application should be made as a
seed soak. Treat 3 Ibs of carrots seeds per 6 gallons of soaking solution for 24
hours at 30 C. Allow the seeds to thoroughly dry before packaging or planting.
Use of treated seed for food or feed purposes is prohibited.
Cherries (See "Stone Fruits")
Chinese Mustard
Foliar
Ground

50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482]
4 Ib/gal SC/L [264-562]
0.5 Ib/A

4

2.0 Ib/A

10

Use limited to FL. Applications may be made in a minimum of 50 gallons of
water/A. Initial application should be made when conditions become favorable
for disease development. Additional applications may be made at 7- to 14-day

Clover (Seed Crop Only)



Foliar





50% WP
[OR960011]
4 Ib/gal F1C
[OR960012]





l.Olb/A






2






2.0 Ib/A






NS



Use limited to crimson clover grown for seed in OR. Applications may be made
with surfactants and in a minimum of 12 gallons of water/A. Initial application
should be made when disease first appears. A second application may be made
prior to the 10-inch growth stage or no later than May 31. The product labels
prohibit the following: use on crimson clover grown for livestock feed; feeding
or grazing of livestock on treated crimson clover; cutting of treated crimson
clover for forage and hay; and use of harvested seed for sprouting. No portion of
the treated field including seed, seed screenings, hay, forage, or stubble may be
used for human or animal feed.
88

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Site
Application Timing
Application Type
Application
Equipment
Formulation
[EPA Reg. No.]
Maximum
Single
Application
Rate (ai)
Maximum
Number of
Applications
Per Season
Maximum
Seasonal
Rate (ai)
Preharvest
Interval
(Days)
Use Limitations '• 2- 3
Currants (See "Bushberries")
Elderberries (See "Bushberries")
Garlic
In-furrow at
planting
Ground
50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482]
2.0 Ib/A
1
2.0 Ib/A
-
Application may be made in a minimum of 20 gallons of water/A. Application
should be made as an in-furrow spray in sufficient water to obtain thorough
coverage of the open furrow and covering soil.
Ginseng
Foliar
Ground
50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482]
l.Olb/Aor
0.75 Ib/A
(when tank
mixed with
other
fungicides)
5
5.0 Ib/A
36
Applications may be made in a minimum of 10 gallons of water/A. Initial
application should be made when conditions become favorable for disease
development. Additional applications may be made at 7- to 14-day intervals.
Gooseberries (See "Bushberries")
Grapes
Foliar
Ground
50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482]
4 Ib/gal SC/L [264-562]
l.Olb/A
4
4.0 Ib/A
7
Applications may be made in a minimum of 50 gallons of water/A. Initial
application should be made at early to mid bloom, the second prior to bunch
closing, the third at beginning of fruit ripening, and the fourth prior to harvest.
Huckleberries (See "Bushberries")
Lettuce (Head and Leaf)
Foliar
Ground/aerial
50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482]
4 Ib/gal SC/L [264-562]
l.Olb/A
3
3.0 Ib/A
14
Applications may be made in a minimum of 40 gallons of water/A; aerial
application can only be used for the first spray. Initial application should be
made at the 3-leaf stage to just after thinning. Two additional applications may
be made at 10-day intervals.
Loganberries (See "Caneberries")
Nectarines (See "Stone Fruits")
Onions (Dry Bulb)
Foliar
Ground/aerial
50% DF [264-524]
50% WP [264-453],
[264-532], [CA860064]
4 Ib/gal F1C [264-482]
4 Ib/gal SC/L [264-562]
0.75 Ib/A or
0.5 Ib/A
(when tank
mixed with
other
fungicides)
5
or
10
(tank mix
rate)
3.75 Ib/A
or
5.0 Ib/A
(tank mix
rate)
7
Applications may be made in a minimum of 50 (ground), 10 (aerial), or 6 (aerial
CA860064) gallons of water/A. Initial application should be made when
conditions become favorable for disease development. Additional applications
may be made at 7- to 14-day intervals.
89

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Site
Application Timing
Application Type
Application
Equipment
Formulation
[EPA Reg. No.]
Maximum
Single
Application
Rate (ai)
Maximum
Number of
Applications
Per Season
Maximum
Seasonal
Rate (ai)
Preharvest
Interval
(Days)
Use Limitations '• 2> 3
Peaches
Foliar
Ground/aerial
50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482]
4 Ib/gal SC/L [264-562]
0.5-1.0
Ib/ai
3
3.0
No later than
petal fall
Applications may be made in a minimum of 20 gal (ground) or 15 gal (air).
Apply at pink bud, full bloom and petal fall.
Peanuts
Foliar
Ground
50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482]
l.Olb/A
3
3.0 Ib/A
10
Applications may be made in a minimum of 40 gallons of water/A. Initial
application should be made when conditions become favorable for disease
development. Two additional applications may be made at 14- to 21 -day
intervals. The feeding of peanut hay to livestock is prohibited. Use of the 50%
WP [EPA Reg. No. 264-532] is limited to states other than CA.
Peas (Seed Treatment)
Seed treatment
Ground
50%WP[WA930026],
[WA930027]
2.8 oz/cwt
1
2.8 oz/cwt
-
Use limited to seed treatment of peas in WA. Application should be made in
sufficient water to ensure complete seed coating. Seeds should be allowed to dry
before packaging or planting. Use of treated seed for food or feed purposes is
prohibited. Treated seed must be labeled: "For export to Sweden only - not to be
sold or offered for sale in the U.S."
Plums (See "Stone Fruits")
Potatoes
Foliar
Ground/aerial
Foliar
Ground

50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482],
4 Ib/gal SC/L [264-562]
1.5 Ib/gal SC/L
[ID960011]
[MO960002],
[OR960033] ,[MN960004
]
50% WP
[CA880019]
50% WP
[CA900013]
l.Olb/A
0.56 Ib/A
l.Olb/A
l.Olb/A
4
7
2
4
4.0 Ib/A
4.0 Ib/A
2.0 Ib/A
4.0 Ib/A
14

-
Applications may be made in a minimum of 10 gallons of water/A; aerial
equipment can only be used for the first application. Initial application should be
made when conditions become favorable for disease development. Additional
applications may be made at 7- to 28-day intervals.
Use limited to CA. Applications may be made in a minimum of 10 gallons of
water/A. Initial application should be made prior to row closing. A second
application may be made 28 days later.
Use limited to greenhouse-grown potatoes in CA. Applications may be made in a
minimum of 100 gallons of water/A. Initial application should be made when
conditions favorable for disease development persist. Three additional
applications can be made at 7- to 10-day intervals. Use of treated commodity for
food/feed is prohibited.
Raspberries (See "Caneberries")
90

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Site
Application Timing
Application Type
Application
Equipment

Formulation
[EPA Reg. No.]


Single
Application
Rate (ai)


Number of
Applications
Per Season


Maximum
Seasonal
Rate (ai)


Preharvest
Interval
(Days)


Use Limitations '• 2> 3

Rice








50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/galFIC [264-482],
[264-520]




0.5 Ib/A






2






l.Olb/A





No later than
75% heading
stage


Applications may be made in a minimum of 10 gallons of water/A. Initial
application should be made between joint movement and booting stages. A
second application may be made 14 days after the first application, but no later
than 75% heading. Use of 50% WP (EPA Reg. No. 264-532) and 4 Ib/gal F1C
(EPA Reg. No. 264-520) is limited to states other than CA. Application to areas
where catfish and crayfish are commercially cultivated is prohibited. Endangered
species restrictions are specified for use in AR.
Stone Fruits (Including Apricots, Cherries, Nectarines, Plums, and Prunes)
Foliar
Ground/aerial

50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482]
4 Ib/gal SC/L [264-562]
l.Olb/A

4

4.0 Ib/A

7

Applications may be made in a minimum of 20 (ground) or 1 5 (aerial) gallons of
water/A. Initial application should be made at bud stage and/or if conditions
favorable for disease development persist. Three additional applications can be
made at 7- to 14-day intervals.

Strawberries

Pieplant dip
Ground



Ground/aerial

50% DF [264-524]
50% WP [264-453],
F964 5371
4 Ib/gal F1C [264-482],
4 Ib/gal SC/L [264-562]
50% DF [264-524]
50% WP [264-453],
[264-532]
4 Ib/gal F1C [264-482]
4 Ib/gal SC/L [264-562]

l.Olb/100
gal

l.Olb/A or
0 5 Ib/A

mixed with
fungicides)

i


4
or
10
(tank mix
rate)

l.Olb/100
gal

4.0 Ib/A
or
5.0 Ib/A
(tank mix
rate)






0


Application may be made as a preplan! dip (5 minutes) immediately prior to
planting.


Applications may be made in a minimum of 100 (ground) or 10 (aerial) gallons
of water/A. Initial application should be made no later than 10% bloom.
Additional applications can be made at 7- to 14-day intervals.

1  The restricted entry interval (REI) is 12 hours.
2  The following rotational crop restrictions are established: (I) beans, broccoli, carrots, Chinese mustard, cotton, garlic, lettuce, onions (dry bulb), peanuts, potatoes, and rice may be rotated after
harvest; and (ii) cotton, root crops, and tomatoes may be rotated one month following the last Iprodione application.
3  Grazing restrictions are established for almonds, grapes, and stone fruits. The grazing of animals in treated orchards is prohibited. The feeding of cover crops grown in treated orchards is
prohibited.
4    Use directions for the 4 Ib/gal SC/L (EPA Reg. No. 264-562) are for homeowner use.
                                                                                      91

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                    (2)    Dietary Risk Assessment/Anticipated Residues

       EPA calculated specific anticipated residues for determination of  upper bound
carcinogenic risk from iprodione.  It should be noted that some anticipated residues were
higher than previous estimates because residue estimates were refined with additional data
from the USDA's Pesticide Data Program (PDF).  As part of a previous Dietary Residue
Exposure  System (ORES) analysis, anticipated residues based on monitoring data were
adjusted for percent crop treated data. EPA has updated these percent crop treated data and
this analysis reflects the revised values.

                    (3)    Exposure and Risk From Food Sources

                           (a)    Acute Dietary Risk (Tier 1/2/3/4)

       Two analyses of acute dietary exposure and risk were performed using DRES, one
for all presently registered commodities and one for all commodities proposed for tolerances.

       The DRES detailed acute analysis estimate the distribution of single-day exposures
for the overall U.S. population and certain subgroups. The analysis evaluated individual food
consumption  as reported by  respondents  in the USD A  1977-78  Nationwide  Food
Consumption Survey (MFCS) and accumulates exposure to the chemical for each commodity.
The analysis assumed uniform national distribution of iprodione in the commodity supply.

       Acute dietary exposure to iprodione was estimated by DRES. Acute dietary exposure
estimates are considered to be high end, because exposure estimates are based on tolerance
level residues in all foods. High end acute dietary exposure was then compared with the acute
NOEL of 20 mg/kg/day for iprodione, and expressed as a margin of exposure (MOE). The
Margin of Exposure (MOE) is a measure of how close the high end exposure comes to the
NOEL (the highest  dose at which no effects were observed in the laboratory test), and is
calculated as the ratio of the NOEL to the exposure (NOEL/exposure = MOE).

       For iprodione, the target MOE for acute dietary risk is 300; MOEs above 300 are not
considered to be of concern.   For iprodione, the target MOE of 300  includes a 3X
uncertainty factor for FQPA considerations.  Acute MOEs for iprodione are calculated for
females 13+ only because the toxicological  endpoint, decreased anogenital  distance, was
noted in neonates following in utero exposure to iprodione.

       DRES results for the acute dietary assessment were of concern for both existing and
proposed  tolerances for  iprodione. Exposure to tolerance  level  residues  on presently
registered commodities resulted in an acute dietary exposure of 0.18 mg/kg/day and an MOE
of 111 for females 13+years old (13+).  Exposure to tolerance level residues on currently
registered commodities and those proposed for tolerances results in an acute dietary exposure
of 0.30 mg/kg/day and an MOE of 66. As stated above, the target MOE for iprodione is 300.
As previously noted, this acute dietary (food  only) exposure assessment is conservative
because it assumes tolerance level residues  on all commodities with present or proposed
iprodione tolerances and 100 percent crop treated.
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               The Registrant submitted an acute Monte Carlo dietary exposure assessment in 1997
        which was revised to reflect risk mitigation measures.  On September 30, 1998, the Agency
        found this acute Monte Carlo assessment to be acceptable for regulatory purposes.  The
        assessment uses the Continuing Survey of Food Intake of Individuals  (CSFII) 1989-1992
        consumption database as translated by Novigen.  This database is acceptable.

               The Novigen assessment was highly refined, using a distribution of residue levels for
        commodities and percent crop treated data in the analysis. Field trial data or monitoring data
        supplied  by Rhone-Poulenc were used for all  crops.  The field  trials  selected were
        appropriately matched to  the  maximum label  rates for iprodione  as  reflected  by risk
        mitigation.

               The results of the acute dietary Monte Carlo are provided in table 25 along with the
        results of the acute dietary analysis using EP A's Dietary Residue Exposure System (DRES).
        For the acute Monte Carlo dietary risk assessment, using a NOEL of 20 mg/kg/day, females
        13+ have MOEs greater than 300 at the 99.9th percentile of exposure.

 Table 25.  Acute Dietary Risk as Indicated by Margins of Exposure (MOE)*.
Population
Subgroup
Females 13+
Dietary Exposure, mg/Kg/day
DRES existing
tolerances
0.18
DRES proposed
tolerances
0.3
Monte Carlo
99.9fh%tilQ
0.056839
MOE
DRES existing
tolerances
111
DRES proposed
tolerances
66.6
Monte Carlo
99.9th%tile
351
*  MOEs from the Novigen Acute Monte Carlo were recalculated using the EPA NOEL (20 mg/kg/day); ** Margin of
exposure is the NOEL + the exposure estimate.

                           (4)    Chronic, Non-Carcinogenic Risk (TMRC and ARC)

              The total dietary exposure for iprodione, expressed as % Chronic  FQPA RfD, was
       calculated for iprodione using the following equation:
              % Chronic FQPA RfD = .
TMRC or ARC mg/kg/dav
X 100%
                                       Chronic FQPA RfD of x mg/kg/day
              Exposure from current registered uses of iprodione results in an estimated risk which
       represents < 1% of the RfD for all populations.

               The chronic analysis for iprodione is a highly refined estimate of dietary exposure.
        Refinements such as percent  crop  treated  data  and anticipated  residues have been
        incorporated. Based on the risk estimates calculated in this analysis, chronic dietary risk from
        the uses recommended through reregi strati on, does not exceed EPA's level of concern.

                             (5)    Chronic, Carcinogenic Risk (ARC)

               The upper bound carcinogenic risk from food uses of iprodione for the general U.S.
        population was calculated using the following equation:
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Upper Bound Cancer Risk = Dietary Exposure (ARC) x Qx*

       Based on a Qt* of 0.0439 (mg/kg/day)"1, the upper bound cancer risk was calculated
to be 4.0 x 10"6 contributed through all the published uses for iprodione. The overall upper
bound risk appears to be above the range the Agency generally considers negligible for excess
life time cancer risk. The commodities which contributed the most to this risk figure are stone
fruits  at 1.4 X 10'6 and small fruits and berries at 1.0 X 10'6.

       The upper bound cancer risk for all commodities with reassessed tolerances before
risk mitigation was calculated to be 3.9 X 10"6 before risk mitigation and 1.8 x  10"6 after risk
mitigation.  The commodities which contribute the most to this  risk figure are grapes
(including wine and sherry) at 1.0  x 10"6, stone fruits  at 1.5 X 10"6, and small fruits and
berries at 0.6 x 10"6. The upper bound cancer risk based on ARC for all commodities with
proposed (reassessed) is above the range the Agency generally considers negligible for excess
life time cancer risk.

                    (6)    Drinking Water Exposure

       The Agency has evaluated potential drinking water exposure from iprodione in ground
and surface water.

                           (a)     Ground Water (modeling/monitoring)

       EPA originally had a concern for iprodione in groundwater based on modeling results.
However, when EPA conducted a Tier 2 Drinking Water Assessment, they concluded that
iprodione  leaching to groundwater is expected to be negligible.  EPA reviewed readily
available groundwater monitoring data for the Tier 2 water assessment.  Iprodione has been
reported in several small scale studies in areas of the U.S. where it is or is suspected of being
used.  Impact to ground water source drinking water is expected to be minimal when the
known environmental fate and monitoring data,  showing all  samples below the LOQ, are
considered.

       From April to October 1996 monitoring in 40 wells along the Oregon coastal region
was conducted. Eighty-nine samples were collected, up  to four samples at some wells over
the period of the study, from the 40 wells. All samples were reported as below the level of
quantification (LOQ); 0.1  ppb. No correlation  with use areas was established, although
samples were collected from areas with  known grape production.

       In  another study along the Central Snake River basin in Oregon, 27 wells were
sampled for a total of 30 samples. Iprodione was detected in all samples, but were reported
as below the level of quantification (0.1 ppb) in all samples. The study was conducted during
a three day period during August 1996.  No correlation with the use of iprodione was
established.
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       A study conducted in the Lake Superior Western Basin in Wisconsin during July 1995
at two wells reported all samples (5) as below the LOQ of 0.55 ppb. No information on why
the samples were collected could be established.

       Lastly, the Pesticide In Ground Water Database (EPA, 1992) reported one study in
Massachusetts during 1986 in which 15 wells were sampled. No samples reported finding
iprodione.

       Monitoring data are limited by the lack of a correlation between sampling date and the
use patterns of the pesticide within the drainage basin studied. Also, the monitored wells
were not associated with groundwater drinking water sources.

                    (7)    Surface Water (modeling/monitoring)

       Because the tier I drinking water exposure assessment for  iprodione  showed
exposures of concern, EPA conducted  a Tier II drinking water exposure assessment.  The
Tier II assessment for iprodione uses PRZM 2.3 for simulating the agricultural field and
EXAMS 2.94 for fate and transport in surface water. Spray drift was simulated using the
assumption that  1% of applied iprodione reached surface water at the time of application and
95% of the chemical deposited on the target site. The remaining 4% either remained airborne
or deposited on  the ground beyond the drainage basin for the pond.

       The scenarios chosen  for iprodione were a peach orchard in Peach County, Georgia
and a grape vineyard in Chautauqua County, New York. Scenarios were chosen to represent
sites  that  were  expected to  produce runoff greater than  90% of the  sites where the
appropriate crop is grown. Model simulations were made with the maximum application
rates, maximum number of yearly applications,  and the  shortest recommended application
interval (Table 26). Tier II upper tenth percentile EECs are presented in Table 27. The EECs
have been calculated so that in any given year, there is a 10% probability that the maximum
average concentration of that duration in that year will equal or exceed the exposure estimate
(EEC)  at the site.

       The Tier II EECs are based on a high-end exposure scenario for the use of a pesticide
on a peaches. The meteorology and agricultural practice are simulated at the site over multiple
(in this case, 23-34) years such  that the probability of an EEC occurring at that site can be
estimated. EECs were calculated for Rovral (iprodione) as this was the formulation registered
for use on the specific crops.

       To represent the  use  on peaches, three applications were made prior to petal fall
according to label directions at  specific intervals (14 days after first application and again 7
days later) beginning with bud emergence. All applications were assumed to made by ground
spray.
       On grapes, four applications were made during the growth cycle; at mid-bloom, prior
to bunch closing, beginning of fruit ripening, and seven days before harvest. Approximate

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       pesticide application dates in the growth cycle were established with the assistance of the lead
       viticulturist from the Fredonia Regional Extension Office in New York. All applications were
       are made by ground spray equipment directly onto the growing plant.

Table 26.  Usage Practice for Modeling Iprodione.
Chemical
Iprodione
Crop
Peaches
Grapes
Application
Method
Ground Spray
Ground Spray
Application Rate
Iprodione
(Ib acre'1)
1.0
2.0
Maximum Annual
Applications
3
4
Application
Interval
14/7 days
Variable
Table 27.  Tier II Upper 10th Percentile EECs for Iprodione Use on Peaches and Grapes.
Crop
Peaches
Peaches
Grapes
Grapes
Aerobic Soil
Metabol. Rate
(tl/2)
90 Day
45 Day
90 day
45 day
Estimated EEC's (ug/1)
Max.
14.7
12.7
13.0
10.3
4 Day
13.8
11.9
11.5
8.6
21 Day
11.0
9.4
10.0
5.5
60 day
8.1
7.2
7.6
3.6
90 Day
6.7
6.1
7.4
3.6
Long Term Mean
1.5
1.4
2.8
1.1
              PRZM2.3 is a runoff model, which can estimate the off-site movement of synthetic
       organic chemicals from agricultural fields over a period of up to 36 years. PRZM2.3 was
       developed to simulate the transport and transformation of field-applied pesticides in the crop
       root zone and the vadose zone taking into account the  effects of agricultural management
       practices. It is considered to be appropriate for modeling most agricultural field crops on
       mineral soils in  the US.  Using input variables  such as pesticide fate properties, soil
       characteristics, soil/crop management practices, and daily weather, PRZM2.3 can simulate
       a pesticide's fate and transport in/on soil and plants, leaching to the bottom of the root zone,
       water runoff and soil erosion.  The output that is linked to EXAMS 2.94 includes estimated
       runoff volume,  sediment yield, and associated edge of the field pesticide losses (which
       constitute pesticide loadings to edge of the field surface water).

              Surface water models such as EXAMS 2.94 simulate pesticide fate and transport in
       surface water and sediment. Input includes runoff volume, and pesticide losses dissolved in
       runoff water and adsorbed to eroding soil  (from PRZM2.3)  as well as pesticide fate
       properties, and receiving water characteristics. Output includes estimated peak and various
       average pesticide concentrations dissolved in the water column, adsorbed to suspended
       sediment, and adsorbed to bottom sediment as a function of time and location.

              It should  be noted that PRZM2.3/EXAMS 2.94  were designed for use in ecological
       risk assessment.  Drinking water taken from surface water tends to come from bodies of
       water that are substantially larger than a 1 hectare by 2 meters  deep pond.  As in the case of
       the Tier 1 screen, PRZM2.3/EXAMS 2.94 assumes that the entire basin (a 10 hectare field)
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receives an application of the chemical. In virtually all cases, basins large enough to support
a drinking water utility contain some fraction of area which  does not receive the chemical.
Furthermore, there is always at least some flow (in a river) or turn over in a reservoir or lake.
Pesticide concentrations modeled using PRZM2.3/EXAMS 2.94 represent upper-bound
concentrations that  may actually occur in small surface water features (e.g., ponds and
streams).    Therefore,  PRZM2.3/EXAMS 2.94 should  be  considered as  a screen.
PRZM2.3/EXAMS 2.94 may over-estimate the actual drinking water concentrations.

       Screening models such as PRZM2.3/EXAMS 2.94 are best used to determine that a
chemical poses little or no exposure.   If, a risk assessment  performed using an high-
end/upper-bound exposure modeled by PRZM2.3/EXAMS 2.94 does not exceed EPA's level
of concern, then there would be no reason to refine the assessment.

                    (8)     Drinking Water Risk

       In the absence of reliable, available monitoring data, EPA uses models to estimate
concentrations of pesticides in ground and surface water.  For iprodione, modeling was used
to estimate surface water concentrations because of very limited surface water monitoring
data.  However, EPA does not use these model estimates to quantify risk.  Currently, EPA
uses drinking water levels of concern (DWLOCs) as a surrogate to capture risk associated
with exposure to pesticides in drinking water. A DWLOC is the concentration of a pesticide
in drinking water that would be acceptable as  an upper limit in light of total aggregate
exposure to that pesticide from food, water, and residential uses (if any).  A DWLOC will
vary depending on the residue level in foods, the toxicity endpoint and with drinking water
consumption patterns and body weights for specific subpopulations.

       EPA believes the PRZM2.3/EXAMS 2.94 model  estimates to be overestimations of
concentrations of iprodione expected in drinking water at the consumer tap.  Iprodione is
expected to be removed through treatment at most drinking water utilities by coagulation
followed by sedimentation and by continued metabolism. Given low concentrations estimated
in surface water (1-3 ppb) and the likelihood of removal through treatment, the Agency does
not believe iprodione will be present in drinking water above the DWLOC. To confirm that
iprodione concentration estimates are overestimates, a surface water monitoring study for
iprodione is needed from Rhone-Poulenc. Since this is a non-guideline study, the surface
water monitoring study will be forwarded to Rhone-Poulenc via a separate Data Call-In after
review by the Office of Management and Budget (OMB). If the results of the study indicate
that there is a concern with concentrations of iprodione in surface water, additional risk
mitigation may be taken by the Agency.

       The equations below were used to calculate the DWLOCchronic based on aggregate
exposure to iprodione through food and drinking water.

       *Exposure to iprodione in drinking water (mg/kg/day) = chronic Rf D - (food exposure + residential
       exposure)

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       [* The chronic FQPA RfD is 0.02 mg/kg/day. Food exposure is taken from the chronic DRES
       analysis for each subpopulations for which a DWLOC value is calculated. Residential exposures
       equal zero.]

       Exposure (adults) (mg/kg/day) = 0.02 mg/kg/day - (0.0002 mg/kg/day + 0) = 0.0198 mg/kg/day

       DWLOCctoomc for adult males (ug/L) = (0.0198 mg/kg/day) (70 kg) - (2L) (10'3 mg/ug) = 693 ug/L

       DWLOCctoomc for adult females (ug/L) = (0.0198 mg/kg/day) (60 kg) - (2L) (10'3 mg/ug) = 594 ug/L

       Exposure (child) (mg/kg/day) = 0.02 mg/kg/day - (0.0003 mg/kg/day + 0) = 0.0197 mg/kg/day

       DWLOCctoomc for child (ug/L) =  (0.0197 mg/kg/day) (10 kg) - (1L) (10'3 mg/ug) = 197 ug/L

       Conservative model estimates of a long-term average concentration of iprodione in
surface water associated with use on peaches and grapes range up to a few parts per billion
(1 to 3 ug/L).  The  estimated concentrations in surface water are much lower than  EPA's
calculated drinking water levels of concern (DWLOCs) for the above subpopulations for
chronic exposure and risk assessments.

       EPA also calculated DWLOCacute.  The equations below were used to calculate the
DWLOCacute based on aggregate exposure through food and drinking water.

       Acute Exposure to iprodione in dw  (mg/kg/day) = (NOEL/MOE) - food exposure
(mg/kg/day). The NOEL = 20 mg/kg/day; The acceptable MOE = 300. The food exposure
is based on exposure for the population females 13+ at the 99.9th percentile of exposure
(0.055851 mg/kg/day).

       Exposure (females 13+) (mg/kg/day) = (20/300) - (0.055851 mg/kg/day) = 0.0108 mg/kg/day
       DWLOCacute = (0.0108 mg/kg/day)(60 kg)  / (2L/day x 10'3 mg/kg/day) = 324 ug/L

       EPA compared concentration estimates from PRZM2.3/EXAMS 2.94 model to the
calculated DWLOC value for females  13+ to provide a screening-level (qualitative) risk
estimate  for iprodione in  surface water.   Conservative model  estimates of maximum
concentrations in surface water associated with use on peaches and grapes range from 10-15
ppb (ug/L).  The estimated concentrations  in surface water are much  lower than  EPA's
DWLOC (324 ug/L) for the population of females 13+.

       EPA also calculated DWLOC values for the short-term endpoint and compared
concentration estimates from the PRZM/EXAMS 2.94 model to calculated DWLOC values
to provide a screening level (qualitative) risk estimate for iprodione in surface water.  If
screening model estimates exceed the DWLOC values,  monitoring data may be required.
DWLOC values  for short-term risk assessments are calculated below  for  adults only.
Residential handler exposure scenarios for short- and intermediate-term inhalation exposure
are not applicable to children. As per OPP's  interim guidance on aggregate risk assessments,
if an oral endpoint is needed for  short-term risk assessment for  incorporation of food, water,

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or oral hand-to-mouth exposures into an aggregate assessment, and only dermal or inhalation
endpoints have been selected, the acute oral endpoint is  used to incorporate the oral
component into the aggregate risk.

       *Exposure to iprodione in drinking water (mg/kg/day) = acute FQPA RfD - (food exposure +
       residential exposure)

       [* The acute FQPA RfD is 0.06 mg/kg/day.  Food exposure is taken from the chronic DRES analysis
       for each subpopulations for which a DWLOC value is calculated. Residential exposures are taken
       from Table 14.  Residential Short- and Intermediate-Term Inhalation Risks at Baseline.]

       Exposure (adults) (mg/kg/day) = 0.06 mg/kg/day - (0.0002 mg/kg/day + 0.002 mg/kg/day) = 0.0578
       mg/kg/day

       DWLOCctoomc for adult males (ug/L) =  (0.0578 mg/kg/day) (70 kg) - (2L) (10'3 mg/ug) = 2000 ug/L

       DWLOCctoomc for adult females (ug/L) = (0.0578 mg/kg/day) (60 kg) - (2L) (10'3 mg/ug) = 1700
       ug/L

       EPA also calculated DWLOC values for the intermediate-term endpoint and compared
concentration estimates from the PRZM/EXAMS 2.94 model to calculated DWLOC values
to provide a screening level (qualitative) risk estimate for iprodione in surface water.  If
screening model estimates  exceed the DWLOC values, monitoring  data may be required.
DWLOC values for intermediate-term risk assessments are calculated below for adults only.
Residential handler exposure scenarios for short- and intermediate-term inhalation exposure
are not applicable to children. As per EPA interim guidance on aggregate risk assessments,
if an oral endpoint is needed for intermediate-term risk assessment for incorporation of food,
water, or oral hand-to-mouth exposures into an aggregate assessment, and only dermal or
inhalation endpoints have been selected, the  oral endpoint on which the FQPA RfD is based
is used to incorporate the oral component into the aggregate risk.

       *Exposure to iprodione in drinking water (mg/kg/day) = chronic FQPA RfD - (food exposure +
       residential exposure)

       [* The chronic FQPA RfD is 0.02 mg/kg/day. Food exposure is taken from the chronic DRES
       analysis for each subpopulations for which a DWLOC value is calculated. Residential exposures are
       taken from Table 14. Residential Short- and Intermediate-Term Inhalation Risks at Baseline.]

       Exposure (adults) (mg/kg/day) = 0.02 mg/kg/day - (0.0002 mg/kg/day + 0.0017 mg/kg/day) = 0.0181
       mg/kg/day

       DWLOCctoomc for adult males (ug/L) = (0.0181 mg/kg/day) (70 kg) - (2L) (10'3 mg/ug) = 633 ug/L

       DWLOCctoomc for adult females (ug/L) = (0.0181 mg/kg/day) (60 kg) - (2L) (10'3 mg/ug) = 543 ug/L

       As noted above, conservative model estimates of a long-term average concentration
of iprodione in surface water associated with use  on peaches and grapes range up to a few
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parts per billion (1 to 3 ug/L). The estimated concentrations in surface water are much lower
than EPA's  calculated  drinking  water levels  of concern (DWLOCs) for the  above
subpopulations for short- and intermediate-term exposure and risk assessments. EPA uses
average residues in water and food in all aggregate risk assessments, except in the acute
aggregate assessment, where high-end food and water residues are used. Model estimates
of iprodione in ground water were not considered for comparison to DWLOC values.

              i.      Food Quality Protection Act Considerations

                     (1)    Cumulative Risk for 3,5-Dichloroaniline

                     Need for Assessment

        Section 408(b)(2)(D)(V)  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."  The Agency believes that "available information" in this
 context might include not only toxicity, chemistry, and exposure data, but also scientific
 policies and  methodologies for  understanding common mechanisms  of toxicity  and
 conducting  cumulative risk assessments.

        Although at present the Agency is still considering how to apply the information in
 its files concerning common mechanism issues to most risk assessments, there are pesticides
 as to which the common mechanism issues can  be resolved.  These  pesticides  include
 pesticides that are lexicologically dissimilar to existing chemical substances (in which case
 the Agency can conclude that it is unlikely that a pesticide shares a common mechanism of
 activity with other substances) and pesticides that produce a common toxic metabolite (in
 which case  common mechanism of activity will be assumed).

        Iprodione is structurally related to Vinciozolin and procymidone, which belong to the
 imide class. Each of these three pesticides can metabolize to 3,5-dichloroaniline (3,5-DCA).
 FQPA  requires EPA to estimate cumulative risk from consumption of food and water
 containing 3,5-DCA derived from iprodione, vinclozolin, and procymidone.

              Hazard Identification for 3.5-DCA

        The Agency has determined that it is not  necessary to include exposure to DCA
 derived from vinclozolin and  procymidone in a cumulative exposure assessment for
 iprodione per se for the following reasons: iprodione residues are measured as DCA by the
 analytical method, thus any DCA formed from iprodione is accounted for in the iprodione
 exposure assessment.  Based on  available  metabolism  data (discussed below)  the
 contribution of DCA from vinclozolin and procymidone to the total chronic iprodione dietary
 exposure is less than an order of magnitude. Therefore, inclusion of DCA from vinclozolin
 and procymidone in the iprodione chronic exposure assessment would not have a significant

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impact on the risk estimates. A similar negligible contribution is expected for acute dietary
exposure.

       3,5-DCA is not a registered pesticide; therefore, there are no FIFRA toxicology data
for this compound. In the past, EPA has used the Qt* for p-chloroaniline (PCA) to assess
the carcinogenic risk for other structurally related chloroanilines. The EPA policy  on
chloroanilines   specifies that chloroaniline metabolites should be  considered  to  be
lexicologically equivalent to PCA unless there is sufficient evidence that the metabolite is not
carcinogenic. No other toxicological endpoints have been identified for DCA.

       Further refinement  to the DCA exposure estimates are being  conducted in
conjunction with the vinclozolin RED. This is being done to reflect risk mitigation measures
proposed for vinclozolin as well as new percent crop treated information.

       A Qj* of 6.38 X 10"2 (mg/kg/day)"1 in human equivalents has been calculated for p-
chloroaniline. This Qt* is based on the  spleen sarcoma rate  in male  rats  from an NTP
bioasssay, linearized low dose multistage model, and the 3/4s interspecies scaling factor.
                    Exposure Assessment

       Exposure to 3,5-DCA will be evaluated from  the following sources: residues of
iprodione- and Vinclozolin-derived 3,5-DCA in food and wine, residues of procy mi done-
derived 3,5-DCA in imported wine, and 3,5-DCA residues in water from agricultural uses
of iprodione and vinclozolin. There are no US registrations for procymidone; therefore, an
evaluation of exposure to procymidone-derived 3,5-DCA in water is not appropriate.

                    (2)   Iprodione-derived 3,5-DCA residues in food

       Metabolism  data  submitted to fulfill guideline requirements  as part of the  re-
registration of iprodione indicated that 3,5-DCA represented  1% TRR (total radioactive
residue) in eggs, smaller proportions in other livestock commodities, and was not detected
in primary or rotational crops.  One percent of the iprodione residues as estimated in a
chronic ORES analysis (US  population) would  be  appropriate values for use in  an
assessment for 3,5-DCA.

       An iprodione chronic  ORES analysis was  performed  in  March 1997, and some
numerical estimates were  run in September 1998 with  mitigation measures in place. This
analysis used highly refined anticipated residues. The estimated exposure for total red meat
was 0.002668 ug/kg/day, for total poultry was 0.001999 ug/kg/day, and for total dairy was
0.004552 ug/kg/day. The estimated exposure for iprodione that will convert to 3,5-DCA
can be calculated by multiplying by 0.001 to convert ug to mg, and by multiplying by 0.01
to account for the 1% TRR.  The estimated dose of iprodione that will convert to 3,5-DCA
is 0.00000009219 mg/kg/day.

       However, iprodione is  also applied to grapes, which are then fermented to produce
wine.  Using an estimated risk of 0.5 x 10"6 for grapes, wine and sherry only, and the

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iprodione Qt* of 0.0439 (mg/kg/day)"1, an exposure of 0.0000114 was estimated for residues
of iprodione in wine.  Assuming that 10% of the iprodione converts to 3,5-DCA, the
estimated dose of iprodione that will convert to 3,5-DCA is 0.00000114 mg/kg/day.

These residues of iprodione must also be converted to 3,5-DCA.  MW iprodione= 330.17

Dose = (0.00000009219 mg/kg/day) (162.02 7330.17) = 0.000000045 mg/kg/day of 3,5-DCA

Dose = (0.00000114 mg/kg/day) (162.02 / 330.17) = 0.00000054 mg/kg/day of 3,5-DCA

                     (3)   Vinclozolin-derived 3,5-DCA residues in food

       Metabolism data submitted to  fulfill guideline requirements as  part  of the re-
registration of vinclozolin indicated that DCA  represented 9.6% TRR in peaches, smaller
proportions  in strawberries and was not detected in lettuce or grapes. Ten percent of the
vinclozolin residues as estimated in a chronic DEEM™ analysis would be appropriate values
for use in an assessment for 3,5-DCA. It was determined to still include grapes, wine in the
analysis based on the metabolism studies for procymidone in which the 3,5-DCA metabolite
was not detected in grapes, but is formed in wine.

       Using these residues a chronic DEEM™ analysis for vinclozolin was performed on
9/28/98. The total anticipated residue contribution for vinclozolin is 0.000122 mg/kg/day.
The estimated exposure for residues of vinclozolin that can be expected to convert to 3,5-
DCA in food can  be calculated by multiplying by 0.1.  The total estimated dose for
vinclozolin that will convert to 3,5-DCA is 0.0000122 mg/kg/day.

Thus, the estimated dose for residues of 3,5-DCA can be determined by:

Dose = (0.0000122 mg/kg/day) (162.02 / 286.11) = 0.0000069 mg/kg/day of 3,5-DCA

                     (4)   Procymidone-derived 3,5-DCA Residues in Wine

       The tolerance for procymidone is for imported wine only.  The 3,5-DCA metabolite
was not detected in grapes, but occurs during fermentation. Anticipated residues in wine are
at 0.3 ppm for parent procymidone, and 0.06 ppm for its 3,5-DCA metabolite.

       The estimated dose is calculated by:
                                         AxBxCxDxExG/F

where
A = concentration of 3,5-DCA in wine = 0.06  ppm
B = 25%, percent of imported wine consumed in the US
C = 20%, percent crop treated
D = 8 fl. ounces wine / day
E = 29.57 g/fl. ounce (conversion factor)
F = 70 kg, default male body weight
G = 0.001 (conversion factor g to kg)
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       The  estimated dose  of residues of  3,5-DCA in wine  that are derived from
procymidone is 0.0000101 mg/kg/day.

                    (5)   3,5-DCA Residues in Water from Iprodione

       A Tier 2 EEC (Estimated Environmental Concentration) was estimated for 3,5-DCA
from the degradation of iprodione as applied to peaches. For Tier 2, two models, PRZM2.3
and EXAMS2, are used to estimate concentrations of pesticide contaminants in surface
water.  PRZM2.3 (Pesticide Root Zone Model) can be linked to EXAMS2 (Exposure
Analysis Modeling System) for a direct transfer of data.

       Using PRZM 2.3 for simulating the transport of the pesticide off the agricultural field
and EXAMS 2 for fate and transport of the chemical in surface water, the Agency estimated
the concentration of iprodione in surface water as a result of an  application to peaches for
a chronic exposure to be 1.5 ppb.

       However, it is possible to refine this assessment by assuming that only some of the
iprodione converts to 3,5-DCA. A soil photolysis study indicates that  a value of 30 % (the
highest percentage found in any of the studies examined) would be reasonable to account for
the iprodione that is actually converted to 3,5-DCA. Thus, the concentration of iprodione
that can be expected to convert to 3,5-DCA can be estimated by:

(1.5 ppb iprodione)(0.3) = 0.45 ppb iprodione that will convert to 3,5-DCA in surface water

This can be converted to ppb of 3,5-DCA using the same MW ratio.

Thus, ppb 3,5-DCA = (0.45 ppb iprodione) (162.02 7330.17) = 0.22 ppb of 3,5-DCA

                    (6)   3,5-DCA Residues in Water from Vinclozolin

       Using GENEEC,  a Tier 1 EEC (Estimated Environmental  Concentration) was
calculated for 3,5-DCA from the degradation of vinclozolin as applied to onions.

       EFED estimated the concentration of vinclozolin in surface water as a result of an
application on onions for a chronic exposure to be 3.27 ppb. However, 20% is the maximum
of the parent vinclozolin that would be expected to convert to 3,5-DCA, based on a field
dissipation study which was extrapolated to water.
Thus, (3.27) (0.2) = 0.65 vinclozolin that will  convert to 3,5-DCA in  surface water.

This can be converted to ppb of 3,5-DCA using the same MW ratio.

Thus, ppb 3,5-DCA = (0.65 ppb vinclozolin)(162.02 7286.11) = 0.37  ppb of 3,5-DCA
                                   103

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                            (7)   Cumulative Risk from all sources of 3,5-DCA

               The carcinogenic risks are estimated by multiplying the dose by the Qx*, 6.38 X 10"2
        (mg/kg/day)"1.  The total carcinogenic risk for consumption of food and wine containing
        residues of 3,5-DCA as a result of applications of iprodione, vinclozolin, and procymidone
        is 9.5 x 10"7 as shown in table 28.

Table 28. Estimated Excess Cancer Risk Values for 3,5-DCA.
Route of Exposure
Iprodione-derived DCA in food
Vinclozolin-derived DCA in food
Procymidone-derived DCA in wine
Iprodione-derived DCA in wine
Total 3,5-DCA in Food and Wine
only
Exposure, mg/kg/day
0.000000045
0.000069
0.0000101
0.00000054

Excess Cancer Risk Estimate
2.9 X 10'9
4.4 X 10'7
4.8 X 10'7 *
2.6 X 10'8 *
9.5X 10-7
* The risk for consuming wine is weighted by the ratio 52/70 which assumes that wine is not consumed during the
first 18 years  of a 70 year lifetime.

              This may be an over-estimate. Metabolism studies for iprodione and vinclozolin were
        used to estimate the amount of 3,5-DCA present in various commodities by using TRRs to
        convert iprodione or Vinclozolin exposures to 3,5-DCA exposures. There is an uncertainty
        to the risk estimate in that a surrogate Qt* is being used for 3,5-DCA.  However, due to the
        structural similarities of 3,5-DCA and PC A, EPA believes that for 3,5-DCA, the use of the
        PCA Qj* represents an upper-bound. These are the best risk numbers that can be estimated
        by EPA.

              Because drinking water data on DCA residues in water are  not  available, EPA
        compared the conservative screening-level model estimates of iprodione concentrations in
        surface water to drinking water levels of concern (DWLOCs) for DCA. Since the cumulative
        risk from food and wine is less than 1 x 10"6, a DWLOC can be estimated:

        (1 x  10-6) - (9.5 x 10-7) = 0.5x 10-7

        0.5 x 10'7 / 0.0638 (mg/kg/day)-1 = 7.8 x 10'7 mg/kg/day

        (7.8 x 10'7 mg/kg/day) (70 kg)(1000 ug/mg) (day/2L), which is approximately 0.03 ug/L or ppb

              The estimated concentrations of 3,5-DCA in water from applications of iprodione
        was 0.22 ppb and is less than the DWLOC calculated for the cancer risk assessment. From
        applications of vinclozlin, the model estimated concentrations of DCA in surface water was
        0.37 ppb. This is above the DWLOC  calculated for the cancer risk assessment; however,
        the  Agency  recognizes  that the model  estimates are very conservative (upper bound
        estimates associated with high uncertainty) and are not likely to be representative of what
        might be expected in drinking water. That is, the difference between the model estimate for
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concentrations of DCA in surface water and the DWLOC calculated for DCA in drinking
water is probably insignificant. To confirm this, the Agency is requesting that the registrant
submit a surface water monitoring study.  This study will replace existing modeled surface
water monitoring data with more accurate data, and will enhance known surface water
monitoring data. If, with the submission of this data, the drinking water level of concern for
iprodione is exceeded, the Agency may require further risk mitigation measures.

       4.      Aggregate Exposure and Risk Assessment/Characterization

       Aggregate exposure and risk is estimated by combining dietary (food and water) and
residential exposures.

              a.      Acute Aggregate  Risk

       Estimated excess cancer risk values for 3,5-DCA policy is to include exposures to
iprodione residues in food and water  only to calculate the aggregate acute dietary risk.
However, EPA notes that exposure to iprodione residues in food alone exceed EPA levels
of concern for acute dietary risk. At this point in time and until the exposure to iprodione
in the diet is reduced or a more refined acceptable risk assessment is provided, any additional
exposure to iprodione through drinking  water would only cause acute risk estimates to
further exceed  EPA's level of concern.   In effect, the drinking  water level  of concern
(DWLOC)  for acute effects of iprodione below the Agency's level of concern. Although
Iprodione uses  are not expected to impact ground water (available monitoring data show
levels at or below limits of quantification and detection), upper bound estimates of iprodione
in surface waters from conservative screening models indicate concentrations of a few parts
per billion.

              b.      Chronic Aggregate Risk

       The chronic aggregate risk assessment for iprodione will include risk estimates
associated with dietary exposure through food,  water, and registered residential uses.
Anticipated  residues  and percent crop-treated data for commodities with published
tolerances result in an exposure to iprodione through food which represents up to 1.6% of
the chronic FQPA RfD for the most exposed subpopulation in the U.S. (non-nursing infants
, <1 year old).  Exposure to all other groups is less than or equal to 1% of the chronic FQPA
RfD.

       EPA has calculated  drinking  water levels of concern (DWLOCs) for chronic
exposure to iprodione from commodities with published tolerances in drinking water for the
following four subpopulations: the general U.S. population/Hispanics (690 ppb), females,
13-19 years old (590 ppb), and  non-nursing infants, <1 year  old (197 ppb).  These
subpopulations were selected because they contain the individuals believed to be those most
highly  exposed subpopulations representing males, females,  and children and infants,
respectively.  A conservative estimate (tier 1) of average concentrations of iprodione in

                                    105

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surface water is 1 to 3 ppb.  The estimated average concentration of iprodione in surface
water is  less than EPA's levels of concern.  Therefore, based on the risk assessments
calculated in this analysis, it appears that the chronic aggregate risk from iprodione in the
diet and drinking water (no residential use scenario was identified for chronic exposure)
associated  with  registered uses of iprodione is not of concern.   Estimated average
concentrations of iprodione  in ground water were not available for comparison against
DWLOC values; however, based  on iprodione's physical/chemical characteristics and
available, but limited monitoring data, it is not expected to significantly impact ground water.

       No chronic exposure scenarios for residential  uses of iprodione were identified;
therefore, no chronic exposure was included in the aggregate risk estimate.

       Therefore,  based  on the  available information, EPA concludes with reasonable
certainty that residues of iprodione in drinking water (when considered along with exposure
from food and residential uses) would not result in an unacceptable chronic aggregate human
health risk estimate at this time. EPA bases this determination on a comparison of estimated
concentrations of iprodione  in surface water to back-calculated "levels of concern" for
Iprodione in drinking water.  The estimate of Iprodione in surface water is derived from a
water quality model that  uses conservative assumptions (health-protective) regarding the
pesticide transport from the point of application to surface water. Because EPA considers
the aggregate risk resulting from  multiple  exposure pathways associated with a pesticide's
uses, levels of concern in drinking water may vary as those uses change. If new uses are
added in the future, EPA will reassess the potential impacts of iprodione on drinking water
as a part of the aggregate risk assessment  process.

              c.      Cancer Aggregate Risk

       Because individual cancer risk estimates for exposures to iprodione residues through
food and residential uses each exceed EPA's level  of  concern individually, combined
exposures through these routes results in an aggregate risk that further exceeds EPA's level
of concern. Any additional exposure through water would cause the risk estimate to further
exceed EPA's level of concern.  Effectively, the DWLOC for cancer below the Agency's
level of concern.  Combined exposure and risk estimates for each of the residential exposure
scenarios plus dietary exposure to iprodione residues results in cancer risk estimates that are
all equal to or greater than 10"6.  Individual risks associated with dietary exposure and
residential exposures must be reduced before additional exposure through drinking water
would be acceptable. Aggregate exposures from combined inhalation and dermal exposures
and the resultant cancer risk estimates  for iprodione are given in Table 29.

              d.      Short-term Aggregate Risk

       Aggregate  risk estimates associated  with short-term risk  includes exposures to
average residues of iprodione in the diet (food and water) and inhalation exposure (1 to 7
days in duration) through the residential application of iprodione. The default assumptions

                                    106

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used in this aggregate risk estimate are that the homeowner's inhalation exposure to
iprodione is equivalent to an oral exposure (100% absorption of the inhaled residues) and
the acute oral  endpoint (acute FQPA RfD of 0.06 mg/kg/day) was used to incorporate
dietary exposures into the aggregate assessment.   (As per OPP's interim  guidance on
aggregate risk  assessments, if an oral endpoint is needed for short-term risk assessment for
incorporation of food, water, or oral hand-to-mouth exposures into an aggregate assessment,
and only dermal or inhalation endpoints have been selected, the acute oral endpoint is used
to incorporate the oral component into the aggregate risk.)  The toxic endpoint selected for
the short-term risk assessment for exposures to iprodione through inhalation is the acute oral
endpoint also selected for the acute dietary risk assessment,  i.e., the acute FQPA RfD.
Therefore, the aggregate short-term risk  assessment was based on the acute FQPA RfD.
The  uncertainty factor for both the acute dietary and the  short-term inhalation  risk
assessments is 300.  The  aggregate risk  assessment includes exposures to  average
concentrations of iprodione residues in the diet from commodities with existing tolerances,
and the high-end exposure scenario associated with homeowners applying iprodione with a
belly grinder to a lawn. The resulting risk represents 3.6%  of the acute FQPA RfD for the
U.S. population representing the most exposed population of adult males and females.  It is
assumed that children and infants do not apply  pesticides.   Although average residues of
iprodione in drinking water were not available, DWLOCs for this short-term aggregate risk
assessment were calculated. They were: for the U. S. population (2000 ppb), and for females
representing women 13+ years of age and nursing (1700 ppb).  As stated above, based on
the available information on iprodione's impact on surface and ground water, EPA believes
that iprodi one's impact on drinking water will not affect the aggregate short-term  risk
significantly. Therefore, EPA concludes with reasonable certainty that residues of iprodione
in drinking water (when considered along with exposure from food and  residential uses)
would not result in an unacceptable short-term aggregate human health risk estimate at this
time.  Any  change in use pattern would necessitate  a reassessment of iprodione  risk
estimates.

              e.      Intermediate-term Aggregate Risk

       Aggregate risk estimates associated with intermediate-term risk includes exposures
to average residues of iprodione in the diet (food  and water)  and inhalation exposure (7 days
to several months in duration) through the residential application of iprodione. The default
assumptions used in this aggregate risk estimate are  that the homeowner's inhalation
exposure to iprodione is equivalent to an oral exposure (100% absorption of the inhaled
residues) and the chronic oral endpoint (chronic FQPA RfD of 0.02 mg/kg/day) was used
to incorporate dietary exposures into the aggregate assessment.  The toxic endpoint selected
for the intermediate-term risk assessment for exposures to  iprodione through inhalation is
the chronic oral endpoint also selected for the chronic dietary risk assessment, i.e., the
chronic FQPA RfD.  Therefore, the aggregate intermediate-term risk assessment was based
on the chronic FQPA RfD.   The uncertainty factor for both the chronic dietary and the
intermediate-term inhalation risk assessments is 300. The aggregate risk assessment includes
exposures to average concentrations of iprodione residues in the diet from commodities with

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existing tolerances, and the high-end  exposure scenario associated with homeowners
applying iprodione with a belly grinder to a lawn. The resulting risk represents 9.5% of the
chronic FQPA RfD for the U.S. population representing the most exposed population of
adult males and females.  It is assumed that children and infants do not apply pesticides.
Although average residues of iprodione in drinking water were not available, DWLOCs for
this intermediate-term aggregate risk assessment were calculated. They were: for the U.S.
population (630 ppb), and for females representing women 13+ years of age and nursing
(540 ppb).  As stated above, based on the available information on iprodione's impact on
surface and ground water, EPA believes that iprodione's impact on drinking water will not
affect the aggregate intermediate-term risk significantly.  Therefore, EPA concludes with
reasonable certainty that residues of iprodione in drinking water (when considered along with
exposure from food and residential uses) would not result in an unacceptable intermediate-
term aggregate human health risk  estimate at this time. Any change in use pattern would
necessitate a reassessment of iprodione risk estimates.
                                108

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Table 29.  Aggregate Dietary and Residential Handlers Exposure and Cancer Risk Estimates for Iprodione.
Residential
Exposure Scenario
Range of
Application Rates
Ib ai/A
Crop Type or
Target
Baseline Total Daily
Dose
mg/kg/day
Number of
Exposures per
Year
LADD mg/kg/day
from residential
Exposure
Dietary ARC
mg/kg/day
Combined
LADDmg/kg/day
diet + residential
Cancer Risk
Residential Handler Risk
Mixing/Loading/Applying
Sprays with a Low Pressure
Handwand (1)
Mixing/Loading/Applying
Using a Backpack Sprayer (2)
Mixing/Loading/Applying
Using a Garden Hose-end
Sprayer (3)
Loading/Applying Granulars
Using a Belly Grinder (4)
Loading/Applying Granulars
Using a Push-type Lawn
Spreader (5)
Loading/Applying Granulars
by Hand as a Spot Treatment
(6)
0.0026 Ib ai/gal
0.01 Ib ai/gal
0.125 lbai/1,000 ft2
0.1 04 Ib ai/gal
0.0026 Ib ai/gal
0.01 Ib ai/gal
0.125 lbai/1,000 ft2
0.1 04 Ib ai/gal
0.0026 Ib ai/gal
0.01 Ib ai/gal
0.125 lbai/1,000 ft2
0.1 04 Ib ai/gal
0.0941 lbai/1,000
ft2
0.0941 lbai/1,000
ft2
0.0941 Ib ai/
1,000 ft2
0.0941 Ib ai/
1,000ft2
0.0941 Ib ai/
1,000ft2
Fruit/Nut Trees
Ornamentals
Turf
Vegetable/
Small Fruit
Garden
Fruit/Nut Trees
Ornamentals
Turf
Vegetable/
Small Fruit
Garden
Trees
Ornamentals
Turf
Vegetable/
Small Fruit
Garden
Turf
Turf
Turf
0.00093
0.0036
0.18
0.037
0.000053
0.00021
0.010
0.0021
0.0028
0.011
0.054
0.11
0.16
0.0073
0.0041
0.00021
0.029
4
4
2
4
4
4
2
4
4
4
2
4
2
2
2
2
2
5.1E-6
2.0E-5
5.2E-4
2.0E-4
2.9E-7
1.2E-6
2.7E-5
1.2E-5
1.6E-5
6.0E-5
1.5E-4
6.0E-4
4.4E-4
2.0E-5
1.1E-5
5.8E-7
7.9E-5
9.13E-5
9.13E-5
9.13E-5
9.13E-5
9.13E-5
9.13E-5
9.13E-5
9.13E-5
9.13E-5
9.13E-5
9.13E-5
9.13E-5
9.13E-5
9.13E-5
9.13E-5
9.13E-5
9.13E-5
9.6E-5
1.1E-4
6.1E-4
2.9E-4
9.2E-5
9.2E-5
1.2E-4
l.OE-4
1.1E-4
1.5E-4
2.4E-4
6.9E-4
5.3E-4
1.1E-4
l.OE-4
9.2E-5
1.7E-4
4.2E-6
4.8.0E-8
2.7E-5
1.3E-5
4.0E-6
4.0E-6
5.2E-6
4.5E-6
4.7E-6
6.6E-6
l.OE-5
3.0E-5
2.3E-5
4.9E-6
4.5-6
4.0E-6
7.5E-6
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                     (1)    Endocrine Disruption

       The available toxicology data for iprodione suggest that it is associated with endocrine effects.
However, the extent of these effects and the mode of action are not yet fully understood.

       Rhone-Poulenc, the iprodione registrant has proposed that the mode  of action for the
production of Leydig cell tumors by iprodione is  disruption of testosterone biosynthesis. The
proposed mode of action and the supporting data have been discussed previously in this document.
This proposed mode of action is not fully understood at this time.

       Also, a special rat developmental toxicity study with iprodione showed decreased anogenital
distance (AGD) at the mid and high dose level (120 and 250 mg/kg/day). However, there were only
marginal differences in AGD between the dose levels.

       EPA is required to develop a screening program to determine whether certain substances
(including all pesticides and inerts) "may have an effect in humans that is similar to an effect produced
by a naturally occurring estrogen, or such other endocrine effect..." The Agency is currently working
with interested stakeholders, including other government agencies, public interest groups, industry
and research scientists in developing a screening and testing program and a priority setting scheme
to implement this program. Congress has allowed 3 years from the passage of FQPA (August 3,
1999) to implement this program.  At that time, EPA may require further testing of this active
ingredient and end use products for endocrine disrupter effects.
C.     ENVIRONMENTAL RISK ASSESSMENT

       1.      Environmental Fate Assessment

       The database for iprodione is largely complete. The maj or routes of dissipation are hydrolysis
in neutral and alkaline environments (half-lives pH 7 = 4.7 days; pH 9 = 27 minutes) and microbial
degradation under both aerobic and anaerobic conditions. The overall result of these mechanisms of
dissipation appears to indicate that iprodione has low to intermediate persistence in the environment.
The results obtained in the field confirm the expected low persistence of iprodione (t1/2=3-7 days).

       The major degradate observed in the laboratory was RP30228 [3-(l-methylethyl)-N-(3,5-
dichlorophenyl)-2,4-dioxo-l-imidazolidine-carboxamide], which was present in the majority of the
laboratory studies.  The chemical was also present at high concentrations in the field. A degradate
of toxicological concern, 3,5-dichloroaniline (RP-32596), was found in several of the laboratory
studies in low to moderate amounts. Its persistence and mobility are not well understood at this time.
Additional studies are needed (aerobic soil metabolism and batch equilibrium) to help characterize
the fate of this toxic degradate and to better estimate its expected environmental concentrations in
both surface water and ground water.

       Iprodione consists of white crystals. Its water solubility is 13 mg/L; its octanol water partition
coefficient is 1259; and it's vapor pressure is 2.7xlO"7 torr.

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             a.     Degradation and Metabolism

                    (1)    Chemical Degradation

       Hydrolysis plays an important role in the degradation of iprodione under neutral and alkaline
aquatic conditions. The hydrolysis rate is pH dependent.  Iprodione hydrolyzed with half-lives of 131
days, 4.7 days, and 27 minutes in sterile aqueous buffered solutions at pH's 5, 7, and 9, respectively.
The major degradates observed were RP35606 [(dichloro-3,5 phenyl)-! isopropyl carbarnoyl-3]-2
acetic acid, with a maximum of 11.9% of the applied at pH 5, and RP30228, with a maximum of
93.3% of the applied at pH 9.

       Iprodione degraded slowly under aqueous photolysis conditions (estimated half-life of 67
days)  in pH 5 buffered solutions irradiated continuously with a UV-filtered xenon-arc lamp.  No
major degradates (> 10% of the applied) were observed.

       Soil photolysis also does not appear to be an important route of dissipation for iprodione. On
irradiated soils, iprodione degraded with an observed DT50 of 7-14 days in sandy loam soil that was
irradiated with a xenon-arc lamp for 8.8 hours/day for 30 days. However, in the dark controls,
[14C]iprodione degraded  with an observed DT50 of 14-21  days.  Therefore, degradative processes
other than photolysis must have been responsible for the disappearance of iprodione in the irradiated
system.  This would be predicted by the results of the photodegradation in water study and the
absorption spectrum (max. <250 nm).  The major degradates observed in the irradiated soil were
RP32596 [3,5-dichloroaniline], (with a maximum of 27.94% of the applied at 14 days), a mixture of
RP25040 [3-(3,5-dichlorophenyl)-2,4-dioxoimidazolidine] and  LS720942 (with a maximum of
13.75% of the applied  at  day 7),  and RP30228  (with a  maximum of 7.72% immediately
posttreatment).

                    (2)    Microbial Degradation

       Iprodione degraded with an observed DT50 of 14-30 days in aerobic sandy loam soil that was
incubated in the dark at 25 C and 75% of 0.33 bar moisture for 276 days. The following degradates
were observed; RP30228, with a maximum of 6.92% of the applied at 14 days, RP32596,  with a
maximum of 9.02% of the applied at 30 days, and RP25040, with a maximum of'9.47% of the applied
at 30 days.  Unextracted  soil 14C-residues were 75.8 to  86.9% of the applied at 181-276 days (last
test interval). Volatile residues totaled 5.27% of the applied at 276 days (of which 5.23% was
14C02).

       Aerobic  aquatic metabolism is an important route of dissipation for iprodione. It degraded
with an observed DT50 of 3-7 days in a flooded silt loam  sediment system incubated in the dark. The
major degradates were RP30228, with a maximum of 64.6% of the applied at 14 days, and RP32490
[l-(3,5-dichlorophenyl)-3-carbamoyl hydantoin], with 14.6% of the applied at 2 days. RP32596 was
a maximum of 9.9% of the applied in the sediment at 30 days.

       Iprodione degraded with an observed DT50 of 7-14 days in anaerobic silt loam sediment. The
major degradates observed were RP30228, with a maximum of 70.7% of the applied at 14 days, and
RP32490, with a maximum of 8.4% of the applied at 30 days.

                                       Ill

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       As  discussed above, the rate  at which iprodione undergoes chemical hydrolysis  is pH
dependent. As such, it could be expected that degradation in soils with pH's at or above 7 would be
more rapid than in acidic soils due to this additional route of dissipation. A close inspection of the
data indicates that the soils in the photolysis on soil and the aerobic soil metabolism studies were
slightly acidic to neutral (6.92 and 5.75, respectively). Furthermore, the degradate profiles for these
studies were different than those observed in the hydrolysis study. It appears reasonable to conclude
that the degradation in these  two studies  was primarily due to metabolism and not chemical
hydrolysis.

       On the other hand, in the aerobic aquatic and anaerobic aquatic metabolism studies, the pH's
were neutral to slightly basic (anaerobic aquatic soil pH 6.4, water pH 7.4; aerobic aquatic soil pH
6.64, water pH 8.5).  The  degradate  profiles in these  studies were similar to those seen  in the
hydrolysis study (with the major degradate RP30228).  It appears that in these studies,  hydrolysis
could have played a major role in the decomposition of iprodione.

                     (3)    Mobility

       Based on  batch equilibrium experiments, iprodione was very mobile  in sand soil:calcium
chloride solution slurries. Iprodione was mobile in sandy loam and loamy sand, and somewhat mobile
in clay soil solution slurries.  Iprodione showed low mobility in  loam sediment:calcium chloride
solution slurries.  The organic matter content appears to be the primary factor affecting the mobility
of iprodione  in soils.  Mobility decreases as the organic  matter  content of the soil or sediment
increases.  Freundlich Kads values were <0.20 for the sand soil, 2.16 for the loamy sand soil, 2.45 for
the sandy loam soil, 6.52 for the clay soil, and 43.09 for the loam sediment.

       In a column leaching study with aged iprodione, the residues were very mobile in columns of
sand soil, mobile to slightly mobile in columns of loamy sand soil, and slightly mobile in columns of
sandy loam and clay soils. The columns were treated with aged (28-29 days) iprodione at 1 Ojig/g and
leached with 20 in. of 0.01 M calcium chloride.  In the sand soil columns, an average of 52% of the
applied radioactivity was recovered from the leachates.  For all the other soil columns, < 1% of the
applied was recovered from the leachates. Five degradates were identified in the column segments
or leachates:  RP25040, RP30228, RP32596, RP35606, and RP36221.

       Iprodione is not expected to volatilize substantially since its vapor pressure is relatively low
(2.7xlO"7 torr).  Its calculated Henry's constant is also low (9.02xlO"9 atm nrVmol). In addition, the
available aerobic soil metabolism study shows that only 5.27% of the applied had volatilized after 276
days in a sandy loam soil. Of this, 5.23% was 14CO2.

                     (4)    Field Dissipation

       Two terrestrial field dissipation studies are available. In both studies, iprodione was applied
8 times to carrots at 1 Ib ai/A/application.  The study conducted  in San Juan Bautista,  California
showed a half-life of 7 days in the 0-15  cm soil layer of a silt loam soil. The degradates RP30228 and
RP32490 were recovered from  the 0-15 and the 15-30 cm soil depths. Iprodione and its  degradates

                                        112

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were not detected below the 30 cm soil level. RP30228 was a maximum average of 0.47 ppm at 28
days after treatment; declining only to 0.15 ppm at 538 days. RP32490 was observed at relatively
low levels (<0.09 ppm) in the field.

       In the study conducted in North Carolina, the observed half-life was less than 3 days in the
0-15 cm soil depth of a loamy sand soil.  RP30228 and RP32490 were observed only in the 0-15 cm
soil depth.  No residues of these degradates or iprodione were detected  below 15  cm.  The
concentrations of RP30228 were lower (ranging from 0.01 to 0.08 ppm until 492 days). A third
degradate, RP32596  [3,5-dichloroaniline] was observed at high concentrations in the  laboratory
experiments, but was not monitored in the field.

       The soil pH's in the field studies varied from slightly acidic (pH 6.2-6.8) in a loamy sand in
Clayton, NC to slightly basic (pH 7.9-8.0) in a silt loam soil in San Juan Bautista, CA.  Based on
these studies, pH alone was not a good predictor of the relative rates of dissipation of iprodione (<4
days in NC, 7 days in CA). However, since RP30228 was a major degradate recovered in the field,
it appears that hydrolysis may be an important route of degradation in the field.

       At this time, EPA does not have an Aquatic Field Dissipation Study of iprodione. Based upon
the two available aquatic metabolism studies and a hydrolysis study, it is reasonable to assume that
iprodione will not persist in aquatic environments.

                     (5)    Accumulation

       In a supplemental Accumulation in  Irrigated Crops  study, iprodione, and its degradates
RP30228 and RP32490 were not detected (<0.05 ppm) in sorghum (whole plant), soybeans (seeds,
pods, trash), sweet potatoes (roots), cotton (whole plant, bolls), or soil irrigated with water from
flooded plots of silt loam soil planted to rice.

       The iprodione octanol/water partition coefficient is slightly greater than 1000 (actual 1258).
This would indicate  limited potential for bioaccumulation.   According to  the submitted study,
iprodione bioaccumulated in bluegill sunfish, with maximum bioaccumulation factors of only 116X
for nonedible tissues, 5IX for edible tissues,  and 72X for whole fish.  Depuration was rapid (t,/2 < 1
day).  The following degradates were detected (>5% of the recovered) in the fish, besides parent
iprodione: RP32490, RP25040, RP30228, and RP36119.

                     (6)    Spray Drift

       Iprodione may be applied through chemigation, aerially, and by foliar ground spray equipment.
No specific spray drift studies were reviewed.

                     (7)    Terrestrial Exposure Assessment

Nongranular applications: The terrestrial exposure assessment is based on Hoerger  and Kenaga
(1972), as modified by Fletcher et al (1994)1. Terrestrial estimated environmental concentrations
       1       Hoerger, F., and E.E. Kenaga.  1972. Pesticide residues on plants: Correlation of
representative data as a basis for estimation of their magnitude in the environment.  In F. Coulston

                                       113

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(EECs) for nongranular formulations were derived from maximum application rates incorporating
dissipation rates for iprodione. Uncertainties arise from a lack of data on interception and dissipation
from foliar surfaces.

Granular applications: EECs for broadcast granular applications are calculated on the basis of mass
(in mg) per area (square foot), corrected for the fraction of the pesticide left on the surface. For
unincorporated broadcast applications, the entire fraction of the pesticide is assumed to remain on
the surface.

Table 30. EECs on Avian and Mammalian Food Items From Applications of 1 Ib ai/A (from Hoerger & Kenaga,
1972, modified by Fletcher et al, 1994).
Food Items
Short grass
Tall grass
Broadleaf plants and small insects
Fruits, pods, seeds, and large insects
Max. EEC (ppm) 1 Ib ai/A
240
110
135
15
Mean EEC (ppm) 1 Ib ai/A
85
36
45
7
                            (8)    Water Resource Assessment

                                  (a)    Ground Water Assessment

       Despite the fact that iprodione is mobile to highly mobile in some soils (Kads=<0.20-43.09),
it is unlikely that it will leach to ground water because of its rapid degradation in the environment,
as demonstrated by  the hydrolysis rate at pH's  7 and 9  (half-life: 4.7 days and 27 minutes,
respectively), the soil metabolism rate (DT50: 14-30 days aerobic, 7-14 days anaerobic) and the field
dissipation half-lives (<3-7 days).  In  addition, because iprodione is typically applied as a foliar
treatment, degradation/metabolism on the plant surface and/or absorption  by plants will  further
mitigate the potential for ground water contamination. However, iprodione has some potential to
persist and leach under certain conditions, i.e., acidic soils with low microbial populations and high
permeability.

       Readily available sources of ground water monitoring data were reviewed for the presence
of iprodione.  Samples collected during 1995  and 1996 were reported to  the Office  of Water's
STORET system. Samples were not correlated with specific use information, however, crops that
iprodione is typically applied to were grown in the sampled watersheds.

       From April to October 1996 monitoring in 40 wells along the Oregon coastal region was
conducted. Eighty-nine samples were collected- up to four samples at some wells over the period
and F. Korte, eds., Environmental Quality and Safety: Chemistry,  Toxicology, and Technology,
Georg Thieme Publ, Stuttgart, West Germany, pp. 9-28.

       Fletcher, J.S., I.E. Nellessen, and T.G. Pfleeger.  1994.  Literature review and evaluation of
the EPA food-chain (Kenaga) nomogram, an instrument for estimating pesticide residues on plants.
Environ. Tox. Chem. 13:1383-1391.

                                        114

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of the study, from the 40 wells.  All samples were reported as below the level of quantification
(LOQ);  0.1 ppb. No correlation with use areas was established, although samples were collected
from areas with known grape production.

       In another study along the Central Snake River basin in Oregon, 27 wells were sampled for
a total of 30 samples.  Iprodione was detected in all samples, but were reported  as below the level
of quantification (0.1 ppb) in all samples. The study was conducted during a three day period during
August  1996. No correlation with the use of iprodione was established.

       A study conducted in the Lake Superior Western Basin in Wisconsin during July 1995  at two
wells reported all samples (5) as below the LOQ of 0.55 ppb. No information on why the samples
were collected could be established.

       Lastly, the Pesticide In Ground Water  Database (EPA,  1992) reported  one study  in
Massachusetts during 1986 in which 15 wells were sampled. No samples reported finding iprodione.

                           (b)    Surface Water Assessment

       Iprodione can contaminate surface water at application by spray drift. Moderate fractions of
applied  iprodione should be available for runoff for several days post-application.  The low to
moderate soil/water partitioning of iprodione indicates that runoff will be primarily by dissolution in
runoff water as opposed to adsorption to eroding soil.

       Iprodione will hydrolyze fairly rapidly in neutral to highly alkaline waters. Biodegradation
will also contribute significantly to the dissipation of iprodione in surface waters with adequate
microbiological activities, thereby somewhat offsetting large decreases in abiotic hydrolysis rates with
decreasing pH (half-life of 131 days at  pH 5).  However, in acidic waters that also have low
microbiological activities and long hydrologic residence times, iprodione should be somewhat more
persistent than in neutral to alkaline waters due to substantially lower hydrolysis rates. Iprodione is
stable to direct aqueous photolysis and has a low volatilization from water potential  (Henry's Law
constant = 9.02 X 10"9  atm*m3/mol).   The DT50 under anaerobic conditions (anaerobic aquatic
metabolism DT50 of 7-14 days) is comparable to the DT50 under aerobic conditions (aerobic aquatic
metabolism  DT50  of 3-7 days) indicating that iprodione will not persist in typically anaerobic
sediments and deep waters.

       The low soil/water partitioning of iprodione indicates that it will probably readily partition into
the water column.  Dissolved concentrations in the water column will  be less than dissolved
concentrations in sediment pore water, but should still be within a somewhat comparable range. The
low octanol/water partitioning of  iprodione (log Kow =  3.1) indicates that  its bioaccumulation
potential is probably low.

       The  Office of Drinking Water  has not established  a MCL or any HALs for  iprodione.
However, according to the Report on Pesticides Which May Pose Dietary Risk: RfDExceeders 1991-
1996 dated March 27, 1997 it has been  identified by EPA/OPP as having potential to pose dietary
risk (chronic toxicity).

                                        115

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       Surface water monitoring data were extracted from the U. S. EPA's Office of Water STORET
Database maintained on the IBM mainframe at Research Triangle Park, North Carolina.

       Iprodione was monitored in four surface water features in the central coastal region of
California near Santa Cruz in 1994.  It is known that iprodione was applied in the watershed of the
monitored sites according to the data owners. All four samples exceeded the minimum detection limit
(0.1  ppb) on the day of sampling;  the date of pesticide application was not ascertained prior to
sampling. Concentrations ranged from 1.07 ppb at Hawkins Slough to 3.53 ppb in a drainage ditch
from a nearby field.  The mean of the four samples was 2.7 ppb.

       Surface water monitoring conducted at three sites on the Oregon coast in 1996 indicated
detection of iprodione in all samples (three single day samples). However, all were below the level
of quantification (LOQ) of 0.1 ppb.  No correlation to use areas was established.

       Preliminary aquatic EECs are estimated using GENEEC (ver. 1.2), a screening model that
provides an upper-bound estimate of EECs on a high exposure site. The GENEEC program uses
basic environmental fate values (adsorption to soil, degradation in soil before runoff and in water) and
pesticide label information (rates, intervals, incorporation, method of application) to  estimate the
EECs in a one-hectare,  two-meter deep pond following the treatment of a 10 hectare field. The
runoff event occurs two  days after the last application.  The model accounts for direct deposition of
spray drift onto the water body (assuming 5% of the application rate for aerial spray applications and
1% for ground spray applications). When risk quotients (RQs) for aquatic organisms are exceeded,
refined aquatic EECs are calculated using PRZM (ver. 2.3)/EXAMS 2.94.

Table 31. Environmental fate parameters used to predict iprodione EECs.
Parameter
water solubility (ppm)
Koc
aerobic soil metabolism, tl/2
hydrolysis tl/2, pH 7
aerobic aquatic metabolism, tl/2
aqueous photolysis tl/2
Value
13 ppm
327
90 days1
Stable
21 days2
Stable
'The observed aerobic soil metabolism DT50 was 30 days. The value was multiplied by a factor of 3 to account for
variability with such studies and the absence of more than one study.
2The observed aerobic aquatic metabolism DT50 was 7 days. The value was multiplied by a factor of 3 to account for variability
with such studies and the absence of more than one study.

       The Pesticide Root Zone Model (PRZM2.3) simulates pesticides in field runoff on daily time
steps, incorporating runoff, infiltration, erosion, and evapotranspiration. The model calculates foliar
dissipation and runoff, pesticide uptake by plants, microbial transformation, volatilization, and soil
dispersion and retardation.  The Exposure Analysis Modeling System (EXAMS 2.94) simulates
pesticide fate and transport in an aquatic environment (one hectare body of water, two meters deep).
                                        116

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Table 32. Estimated Environmental Concentrations (EECs) For Aquatic Exposure from Aerial Application on
Selected Uses Using GENEEC and PRZM/EXAMS 2.94.
Site
ApplicationRate x
No/Interval (da)
	 Pel

Peak
imated Environmental Concentrations (EEC
4-day
21-day
56/60-day
90-day
c~\ 11A U&'1 	
long-term avg
Tier 1: GENEEC
Peanuts
Almonds
Grapes
Peaches
Potatoes
Onions
Strawberries
Turf - Full year1
Turf -Half year
1.0x3/14
0.5x4/14
1.0x4/14
1.0x4/7
1.0x4/10
0.75 x 5/7
1.0x4/10
5.45x26/14
5.45 x 13/14
70
45
88
98
94
89
92
4
1280
1030
66
42
83
93
89
84
87
4
1210
970
49
31
62
68
66
62
64
o
J
890
720
29
19
37
41
40
37
39
2
540
430
—
—
~
—
—
—
~
	
—
—
~
—
—
—
~
	
Tier 2: PRZM2.3/EXAM II 1 in 10 year EECs
Grapes
Peaches
2.0 x 4/Var
1.0x3/7-14
13.0
14.7
11.5
13.8
10.0
11.0
7.6
8.1
7.4
6.7
2.8
1.5
1 The turf, lawn, golf course, etc. uses had no limit to the number of applications per year nor amaximum annual application rate. Therefore, for estimating
maximum exposure, it was assumed that iprodione could be use year-round in the Southern U.S., where the growth cycle of turf grass is year-round. In
the Northern U.S., iprodione is expected to be applied up to 6 months out of the year, from April thru September. Approaching the assessment in this
fashion, bounds the maximum potential exposures from use on turf relative to climate.

                                    (c)     Drinking Water Assessment

              The estimated concentrations provided below for drinking water are for the parent
       iprodione and for 3,5-dichloroaniline.  If other degradates are  included  in the tolerance
       expression or are of toxicological concern, then it may be necessary to re-evaluate monitoring
       data to determine its usefulness in a risk assessment.
                                    (d)     Ground Water Sources

              A preliminary ground water assessment was made using SCI-GROW2 to estimate the
       "maximum" ground water concentration from the application of a pesticide to crops.  SCI-
       GROW is based on the fate properties of the pesticide (i.e., the median Koc and mean aerobic
       soil metabolism half-life), the application rate, and the existing body of data from small-scale
       ground water monitoring studies.  The model assumes that the pesticide is applied  at its
       maximum rate in areas where the ground water is particularly vulnerable to contamination.
       In most  cases, a considerable portion of any use area will have ground water that is less
       vulnerable to contamination than the areas used to derive the SCI-GROW estimates. As  such,
       the estimated "maximum" concentration derived using SCI-GROW should  be considered a
       high-end to bounding estimate of "acute" exposure.  The concentration for parent iprodione
       estimated using SCI-GROW is approximately 0.3 ppb for all use except turf. For turf uses,
       due to the uncertainty associated with the frequency of use, concentrations were estimated
       to be as high  as  11.7 ppb.  The results of this model should  be compared to available
       monitoring data when determining the potential for human exposure.
         Barrett, M. 1997.  SCI-GROW; "A proposed method to determine screening concentrations estimates for
drinking water from ground water sources."  Draft.  USEPA/OPP/EPA, September 1997.
                                              117

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       Absence of appropriate fate data for the degradate 3,5-dichloroaniline did not permit
a quantitative estimate in ground water.  However, due to the low estimated Koc and the
persistence of 3,5-dichloroaniline, it appears that it has a high potential to leach to ground
water.  No ground water monitoring data were available for this assessment.

                           (e)    Surface Water Sources

       Tier II surface water drinking water EECs were calculated using PRZM2.3 to simulate
the agricultural field and EXAMS 2.94 for fate and transport in surface water. Spray drift
was simulated using the assumption that 1% of applied iprodione reached surface water at the
time of application and 95% of the chemical deposited on the target site. The remaining 4%
either remained airborne or deposited on the ground beyond the drainage basin for the pond.
       Environmental fate parameters used to predict iprodione EECs were presented earlier.
The scenarios chosen for iprodione were a grape vineyard in Chautauqua County, New York
and a peach orchard in Peach County, Georgia. Crop specific inputs to PRZM are presented
in the Use Characterization section.  Scenarios were chosen to represent sites that were
expected to produce runoff greater than 90% of the sites where the appropriate crop is
grown. Model simulations were made with the maximum application rate for a 34-year
period. Tier II one-in-ten year (upper tenth percentile) EECs are presented in Table 32. The
EECs have been calculated so that in any given year, there is a  10% probability that the
maximum average concentration of that duration in that year will equal or exceed the EEC
at the site.

       The upper 90% confidence bound on the overall mean concentrations of iprodione
were 2.8  ug/1 from the application to grapes, and 1.5 ug/1 from the application to peaches.
These upper 90% confidence bounds are the best value to use in cancer risk assessments as
they are  the best  estimate of lifetime mean concentrations.  The  maximum 1 in 10 year
concentrations are 13.0 ug/L  from the  application to grapes and 14.7 ug/L from the
application to peaches. These values are the suggested value for use in acute risk assessments.

       Estimated surface water concentrations of 3,5-dichloroaniline attributable to the
breakdown of parent iprodione can be estimated using the percent conversion from the
submitted fate studies.  The estimated upper bound concentration of 3,5-dichloroaniline from
the degradation of iprodione is based on  a maximum conversion of 30 percent seen in an
acceptable soil photolysis study. The 90% upper bound on the overall mean concentrations
for iprodione use on peaches and grapes from the Tier II estimates were multiplied by a factor
of 0.3 to  account for a 30% conversion of parent to 3,5-dichloroaniline.  It is believed that
this represents a maximum conversion, given the much lower degree of conversion seen in
the  soil metabolism and field  studies. It is  likely that the actual concentrations of 3,5-
dichloroaniline will be lower, based on evidence in the  studies that showed a decline in
concentration with time.  Thus, the estimated concentration of 3,5-dichloroaniline attributable

                                    118

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to the breakdown or transformation of iprodione is 0.45 ug/1 (peaches) and 0.84 ug/1 (grapes).
The degree of uncertainty associated with this estimate is considered to be high, therefore,
the error surrounding this estimate may likewise be high. Such factors as applying laboratory
test conditions to the field and degradation and transformation pathways not captured by the
soil photolysis  study may contribute to either overestimating or underestimating actual
environmental concentrations.

                     (9)     Use  of  Screening  Estimates   for  Drinking  Water
                            Assessments

       EPA recommends that the EECs generated from PRZM/EXAMS 2.94 (for surface
water sources) be used for drinking water risk assessments for iprodione. The monitoring
data reported here are not considered reliable for use in drinking water assessments because
they were not well-correlated with the use patterns for iprodione or to drinking water intakes.
Furthermore, an insufficient number of both samples and  sites are available to draw any
supportable scientific conclusions as to the extent of surface water contamination from the
use of iprodione.  The model predictions provide a screen to eliminate those chemicals that
are not likely to cause drinking  water problems.  Exceedances in  drinking water risk
assessments using the screening model estimates do not necessarily mean a problem actually
exists but point  to the need for better data (such as monitoring studies specifically designed
to relate water concentrations to usage) on which to make a decision. It is possible that the
additional data will show no problem; it is also possible that the data will show that in some
instances a problem may still exist.  If degradates are to be included  in the tolerance
expression, the monitoring data may have to be re-evaluated for usefulness and/or the
modeling data will have to be re-calculated to include the appropriate degradates.

       Concentrations estimated using SCI-GROW (ground water sources)  should be used
with caution for drinking water risk assessment purposes.  Estimates for uses other than turf
may reflect conservative "upper bound" estimates of concentrations likely to be found in some
highly vulnerable ground water sources. Estimates for turf use should be examined further
pending receipt of better use characterization data. Monitoring data in known use areas do
not support the presence of iprodione at concentrations estimated using  SCI-GROW on turf,
i.e., more than 2 orders-of-magnitude greater.

       2.    Ecological Effects Hazard Assessment

       For acute exposure,  iprodione  is practically  nontoxic to  slightly  toxic  to birds,
practically  nontoxic to small mammals, relatively nontoxic to bees,  moderately toxic to
freshwater fish, moderately to highly toxic to freshwater invertebrates, moderately toxic to
estuarine and marine  fish,  and  moderately to highly toxic to estuarine  and marine
invertebrates. Chronic toxicity studies established the following NOEC values and ecological
endpoints affected: 300 ppm for birds (decreased hatchling body weight); 500 ppm for small
mammals (decreased fetal weight); >0.26 ppm for freshwater fish (larval survival); >0.17 ppm
                                    119

-------
        for freshwater invertebrates (offspring/female, mean percentage survival, growth); >3.5 ppb
        for estuarine and marine invertebrates (offspring/female/reproductive day).

               Notice that the toxicity testing does not test all species of birds or fish. Only two
        surrogate species for both freshwater fish and birds are used to represent all freshwater fish
        species (2000+) and bird species (680+) in the United States.  For mammals, acute studies
        are usually limited to the Norway rat or the house mouse. Estuarine/marine testing is limited
        to a crustacean, mollusk,  and fish.   Also, reptiles and amphibians are  not tested.  The
        assessment makes the assumption that the bird and reptilian toxicities are the same. The same
        assumption applies to amphibians and fish. Therefore, without definitive testing, it is assumed
        that the conclusions regarding hazards of iprodione to birds and fish apply to other vertebrate
        animals that  are not currently tested.

                               (1)   Toxicity to Terrestrial Animals
                                      (a)     Birds, Acute and Subacute
Table 33. Avian Acute Oral Toxicity.
Species
Northern bobwhite quail
(Colinus virginianus)
Northern bobwhite quail
(Colinus virginianus)
Mallard duck
Anas platyrhynchos
%ai
96.2
Tech, %a.i.
unknown
Tech, %a.i.
unknown
LD50 (mg/kg)
>20003
930"
(744-1163)
10,437
Toxicity Category '
"practically
nontoxic"
"slightly
toxic"
"practically
nontoxic"
MRIDNo. Author/Year
41604101
Culottaetal /1990
Acc# 232703
McGinnis /1973
Acc# 232703
McGinnis /1974
Study Classification2
Core
Core
Supplemental
1 "Practically nontoxic" is given to chemicals with LDjgS greater than 2000 mg/L and "slightly toxic" designates chemicals whose LDjQ falls in a range
between 501 to 2000 mg/kg (Brooks (1973).
2  Core (study satisfies guideline). Supplemental (study is scientifically sound, but does not satisfy guideline)
3  Study conducted with 23-week old birds.
4  Study conducted with 14-day old birds.

               Because the LD50  falls in the range of 501 to > 2000 mg/kg, iprodione is  "slightly
toxic to practically nontoxic" to avian species on an acute oral basis.
is fulfilled (MRID 41604101 and Acc# 232703).
                                                                              The guideline (71-1)
Table 34. Avian Subacute Dietary Toxicity.
Species
Northern bobwhite quail (Colinus virginianus)
Mallard duck (Anas platyrhynchos)
%ai
96.2%
96.2%
5-Day LC50 (ppm)1
>56203
>56204
Toxicity Category2
"practically nontoxic"
"practically nontoxic"
MRID No./ Author/Year
41604102/ Driscoll et al./1990
41604103/Driscolletal.
1 Test organisms observed an additional three days while on untreated feed.
2 "Practically nontoxic" is the designation for chemicals with LCSOs above 5000 ppm based on Brooks'(1973) classification scheme.
3 There was 20% mortality at 5620 ppm at the end of the study.
4 There was no mortality at the end of the study.

               Because  the LC50  values  are greater than 5000  ppm, iprodione  is  "practically
        nontoxic" to avian species on a subacute dietary basis.  The guideline  (71-2) is fulfilled
        (MRID #41604102 and 41604103).
                                      (b)    Birds, Chronic
                                               120

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          Table 35. Avian Reproduction.
Species/ Study Duration
Northern bobwhite quail (Colinus virginianus)
Mallard duck (Anas platyrhynchos)
%ai
95%
95%
NOEC/LOEC (ppm)
300/1000
300/1000
LOEC/ Endpoints
hatchling body weight
fewer 14-day old survivors
MRID No./ Author/Year
00099126/ Beavers & Fink//1981
00086840/ Beavers & Fink//1981
                 The guideline (71-4) is fulfilled (MRID00099126 and 00086840).

                                      (2)    Mammals, Acute and Chronic

                        Wild mammal testing is required on a case-by-case basis, depending on the results of
                 lower tier laboratory mammalian studies, intended use pattern and pertinent environmental
                 fate characteristics. In most cases, rat or mouse toxicity values obtained from the Agency's
                 Health Effects Division (HED) substitute for wild mammal testing. These toxicity values are
                 reported in Table 36 below.
Table 36.  Mammalian Toxicity
Species/Study Duration
Laboratory mouse
96 hours
Laboratory rat
Laboratory rat 96 hours
"
"
Dog
1 year
Rat
3 generation
Rat
2 generation
Rat
2-year
%ai
99.6
97.7%
41.6%
"
"
96.5%
Tech. % not
reported
96.2%
94.5% and
95.7%
Test Type
LD50
LD50
LD50
"
"
Feeding
Reproduction
Reproduction
Feeding/
carcinogenic
Toxicity Value
3050 mg/kg
4468 mg/kg
1 160 mg/kg (1070-1260)(female)
1540 (1140-2080) (male)
1 170 (919-1480) (male and female)
NOEL = 100,
LOEL = 600
Repro. NOEL = 500 ppm and LEL =
2000 ppm
Parental toxicity NOEL = 300 ppm,
LOEL= 1000 ppm
Repro. toxicity
NOEL = 1000 ppm, LOEL = 2000
ppm
Anti-androgenic (male) NOEC=
ISOppm
LOEC= 300 ppm
Affected Endpoints
mortality
mortality
mortality
"
"
Hematopoieticchanges- RBC, Hgb and HCT counts
were lower than in the controls
decreased fetal weight
Parental effects decrease body weight, body weight
gain, and food consumption in both sexes,
Reproductive effects decreased pup viability and
body weight & and an increased incidence of clinical
signs in the pups during the lactation period.
Testicular hyperplasia, reduced spermatozoa in
epididymis adrenal effects
MRID No.
/Ace No.
232701
42306301
236497
"
"
255951
144391
41327001
42211101
232712
41871601
42637801
42787001
              The results indicate that technical iprodione is "practically nontoxic" and formulated iprodione
       is "slightly toxic" to small mammals on an acute oral basis.
                                   (a)
Insects
              A honey bee acute contact study using the TGAI is required for iprodione because its use on
       almond, apricot, beans, blueberry, cherry, clover, cotton, grapes, mustard, cabbage, nectarine, onion,
       peach, peanuts, and plum will result in honey bee exposure. Results of this test are in table 37 below.

         Table 37. Nontarget Insect Acute Contact Toxicity
                                                     121

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Species
Honey bee (Apis mellifera)
%ai
Percentage unknown
LD50 (,ug/bee)
>120.86
Toxicity Category1
"relatively nontoxic"
MRID No. /Author/Year
4426206 1/ Atkins/1975
Study Classification
Core
1 Based on Atkin (et al. 1981; MRID No.: 44038201) LD50 values above 11 //g/bee are "relatively nontoxic".

               The results indicate that iprodione is "relative nontoxic" to bees on acute contact basis.
       The guideline (141-1) is fulfilled (MRID No. 44262021).

                             (3)    Toxicity to Freshwater Aquatic Animals
                                    (a)     Freshwater Fish, Acute
  Table 38. Freshwater Fish Acute Toxicity
Species/
(Flow-through or Static)
Bluegill sunfish
(Lepomis macrochirus)
Bluegill sunfish
(Lepomis macrochirus)
Bluegill sunfish
(Lepomis macrochirus)
Channel catfish
(Ictalurus punctatus)
Rainbow trout
(Oncorhynchus mykiss) static
Rainbow trout
(Oncorhynchus mykiss) static
%ai
95.06%
96.2%
TEP
50%
95%
96.2%
95.06%
96-hour LC50 (ppm)
(measured/nominal)
6.3 (5.2-7.7)
/(nominal)
3.7(3.3-4)
(mean measured cone.)
7.8 (6.9-8.9) (as a.i.)
(mean measured cone.)
3.1(2.6-3.6)
(mean measured cone.)
4.1 (2.9-7)
(mean measured cone.)
4.2(3.2-5.6)
(nominal)
Toxicity Category
"moderately toxic"
"moderately toxic"
"moderately toxic"
"moderately toxic"
"moderately toxic"
"moderately toxic"
MRID No./Author/Year
Acc#234810
Calmbacher/1978
41604104
Sousa/1990
40489203
Surprenant/1987
470254018
Swigertetal/1986
41604105
Sousa/1990
Acc#234810
Calmbacheretal./1978
Study
Classification
Core
Core
Core
Supplemental
Core
Supplemental
  1 Brooks (et al., 1973) toxicity classification indicates that LC50 values >1 to 10 ppm are "moderately toxic".

                Because the LC50 falls in the range of >1 to 10 ppm,  iprodione is "moderately toxic"
         to freshwater fish on an acute basis. The guideline (72-1) is fulfilled (MRTD# Acc# 234810,
         41604104, 40489203, 41604105).

                                      (b)    Freshwater Fish, Chronic

  Table 39. Freshwater Fish Early Life-Stage Toxicity Under Flow-through Conditions
Species/ Study Duration
Fathead Minnow (Pimephales promelas)
%ai
100
NOEC/LOEC (ppm)
>0.26<0.55
MATC1 (ppm)
0.38
Endpoints Affected
Larval survival
MRID No. / Author/Year
4055080 1/ Surprenant/1988
Study Classification
Core
  1 defined as the geometric mean of the NOEC and LOEC.

                The data indicate that exposure to concentrations greater than 0.26 ppm significantly
         reduce larval fish survival.  The guideline (72-4) is fulfilled (MRID No.: 40550801).
                                               122

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                                            (c)    Freshwater Invertebrates, Acute
Table 40. Freshwater Invertebrate Acute Toxicity
Species/(Static or Flow-
through)
Waterflea (Daphnia magna)
Waterflea (Daphnia magna)
Waterflea (Daphnia magna)
Waterflea (Daphnia magna)
Waterflea (Daphniapulex)
Waterflea (Daphniapulex)
Juvenile crayfish
(Procambarus simulans)
%ai
96.2%
94.5%
94.5%
TEP 50%
TEP 50%
Tech. %
unknown
95%
48-hour LC50/EC50 (ppm)
(measured/nominal)
0.24(.21-.31) (mean measured cone.)
0.43(0.31-0.60) (nominal)
7.2(6.0-8.6) (nominal)
0.36(0.34-0.39) (as a.i.)
(mean measured cone.)
5.8(3.2-10.3) (nominal) (72 hr)
4.0(2.9-5.5) (nominal) (72 hr)
>4. 1 (mean measured cone.) (7-day)
Toxicity Category
"highly toxic"
"highly toxic"
"moderately toxic"
"highly toxic"
"moderately toxic"
"moderately toxic"
"moderately toxic"
MRID No./ Author/Year
41642001/McNamara/1990
Acc#232703/Roberts/1977
Acc#232703/Algirdas/1977
40489206/Surprenant/1988
Acc#232703/Ambrosi et al. 1977
Acc#232703/Ambrosi et al. 1977
00162223McAllister et al.1986
Study
Classification
Core
Core
Core
Core
Supplemental
Supplemental
Supplemental
1 Brooks (etal., 1973) classification indicates the LC50 of 0.1 to 1 ppm are in the "highly toxic" range and those greater than 1 to 10 ppm are in the "moderately toxic"
range.

               Because the LC50/EC50 fall in the range of 0.24 to 10 ppm, iprodione is "highly to moderately
       toxic" to aquatic invertebrates on an acute basis.  The guideline (72-2) is fulfilled (MRID No.:
       40489206, 41642001, Ace No. 232703).

                                    (d)    Freshwater Invertebrate, Chronic

Table 41. Freshwater Aquatic Invertebrate Life-Cycle Toxicity
Species/ Flow-through)
Waterflea (Daphnia magna)
%ai
100
21 -day
NOEC/LOEC (ppm)
>0.17<0.33
MATC1
(ppm)
0.24
Endpoints Affected
Offspring/female, Mean
percentagesurvival, growth
MRID No.
Author/Year
40489201
Surprenant /1988
Study
Classification
Core
1 defined as the geometric mean of the NOEC and LOEC.

               The  data indicate that concentrations greater than 0.17 ppm significantly reduce mean
        percentage survival, growth and the number of offspring produced per female. The guideline (72-4)
        is fulfilled (MRID No.:40489201).

                              (4)    Toxicity to Estuarine and Marine Animals

                                     (a)     Estuarine and Marine Fish, Acute

Table 42. Estuarine/Marine  Fish Acute Toxicity
Species/(Static or Flow-through)
Sheepshead minnow (Cyprinodon variegatus)
%ai
95
96-hour LC50 (ppm) (measured)
7.7(7.1-8.4)
Toxicity Category1
"moderately toxic"
MRID No. Author/Year
40489205 Surprenant/1988
1 Brooks (et al.,1973) classification indicates that LCSOs greater than 1 to 10 ppm are "moderately toxic".

               Iprodione is "moderately toxic" to estuarine/marine fish on an acute basis. The guideline (72-
        3a) is fulfilled (MRID No. 404892-05).
                                                  123

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                                  (b)    Estuarine and Marine Fish, Chronic

              Because the acute LC50 is greater than 1 ppm, an estuarine/marine fish early life-stage toxicity
       test using the TGAI is not required for iprodione.

                                  (c)    Estuarine and Marine Invertebrates, Acute

Table 43.  Estuarine/Marine Invertebrate Acute Toxicity
Species/Static or
Flow-through
Eastern oyster (shell deposition) (Crassostrea virginica)
Mysid (Americamysis bahia)
% ai.
95
100
96-hour LC50/EC50
(ppm) (measured)
2.3 (2.02-2.5)
0.68(0.54-1)
Toxicity
Category1
"moderately toxic"
"highly toxic"
MRID No.
Author/Year
40489202/ Surprenant/1987
40489204/Surprenant/1987
Study
Classification
Core
Core
1 Based on Brook's (et al. 9 173) toxicity categories indicate that chemicals with an LC50 between 0. 1 and 1 ppm are "highly toxic".
              Because the iprodione LC50/EC50s fall in the range of >0.1-10 ppm, iprodione is "highly toxic"
       to "moderately toxic" to estuarine/marine invertebrates on an acute basis.  The guideline (72-3b and
       72-3c) is fulfilled (MRID No.: 40489202,  40489204).

                                  (d)    Estuarine and Marine Invertebrate, Chronic

Table 44.  Estuarine/Marine Invertebrate Life-Cycle Toxicity
Species/(Static Renewal or
Flow-through)
Mysid (Americamysis bahia)
%ai
100
21 -day
NOEC/LOEC (ppm)
>0.0035 <0.0075
MATC1
(ppm)
0.0055
Endpoints Affected
Offspring/female/reproductive day
MRID No.
Author/Year
40832201 Surprenant/1988
Study
Classification
Core
1 defined as the geometric mean of the NOEC and LOEC.

              The data indicate that concentrations greater than 3.5 ppb (0.0035 ppm) significantly reduce
       the number of offspring produced by each female.  The  guideline (72-4) is fulfilled (MRID
       No.:40832201).
                                  (e)
Freshwater and Estuarine Field Studies
              Following is a summary of the trends observed in the Aquatic Residue Monitoring study
       (MRID 419836-01) that was found to be supplemental.  The study area was limited in size to five
       fields, 125 to 202 acres each. The small study size significantly miscalculates the amount of iprodione
       entering watersheds in the rice regions. In addition, sample collection methods may have contributed
       to low reported chemical concentrations.

              Iprodione was aerially applied at 0.5 Ibs a.i./A, twice on five 125 to 202 acre rice fields in
       southern U.S. (Louisiana, Texas and Arkansas). The applications were at 13 to 14 day intervals.
       Some of the monitoring sites were in freshwater habitats and the others were located in estuarine
       (brackish) habitats.

              In the water, iprodione concentrations ranged from 
-------
      Iprodione's major degradate, RP-30228, had concentrations ranging from 1.3
41604107 Giddings/1990
41604109/ Giddings/ /1990
416041 10 Giddings/1990
Core
Core (but not required)
Supplemental2 (but not required)
1 Use of sonification to separate the cells is not allowed for this species.
2 Test must give an EC50 result to be core.
                                              125

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       The results of the Tier II studies indicate the requirement for a study conducted with the
vascular plant, Lemna, is still outstanding.  As the label has application rates up to 22 Ibs a.i., the
registrant must either test Lemna up to this rate (or the limit of solubility), or establish an EC50 value
for this plant.  The studies conducted with Navicula and Anabaena do not need to be re-done, as
tests with these aquatic plants are not required to support the uses of fungicides.

       3.      Ecological Risk Assessment

       To evaluate the potential risk to nontarget organisms from the use of iprodione products, risk
quotients (RQs) are calculated from the ratio of estimated environmental concentrations (EECs) to
ecotoxicity values.  RQs are then compared to levels of concern (LOCs) for determination of
potential ecorisk and the consideration of regulatory action.

                     (1)     Exposure and Risk to Nontarget Terrestrial Animals

       For pesticides applied as a liquid product, the estimated environmental concentrations (EECs)
on food items following product application are compared to LC50 values to assess risk.  The
predicted 0-day maximum  residues of a pesticide that may be expected to occur on selected avian
or mammalian food items immediately following a direct single application at 1 Ib ai/A are in table
46 below.

Table 46. Estimated  Environmental Concentrations (EECs) on Avian and Mammalian Food Items (ppm)
Following a Single Application at 1 Ib ai/A
Food Items
Short grass
Tall grass
Broadleaf/forage plants, and small insects
Fruits, pods, seeds, and large insects
EEC (ppm)1
240
110
135
15
1 Maximum EEC are for a 1 Ib ai/A application rate and are based on Fletcher et al. (1994).

                            (a)     Birds

                                   i)      Non-granular Products

       The toxicity data indicate that iprodione is practically nontoxic to birds as the dietary LC50
values are greater than 5620 ppm, which was the highest concentration tested. When the toxicity is
this low, it is unlikely that birds feeding on vegetation and insects contaminated with a pesticide are
likely to be at risk.  As iprodione is nontoxic and since  the toxicity value cannot be precisely
expressed, it is reasonable to conclude that nongranular iprodione is not an acute risk to birds.

                                   ii)     Granular Products

       The only granular applications are broadcast treatments of turf, including golf course turf and
ornamental lawns and turf. Acute risk from  granular formulations is  calculated with the LD50 per
square foot risk index.  The number of lethal  doses (LD50s) that are available within one square foot

                                        126

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       immediately after application (LD50s/ft2) is used as the risk quotient for granular/bait products. The
       following table shows the RQs for songbirds (20g), upland gamebirds (180g) and waterfowl (1 OOOg)
       for granular applications.

Table 47. Avian Risk Quotients for Granular Products (Broadcast) Based on a Northern Bobwhite Quail LD50 of 930
mg/kg.
Site
Ornamental Lawns & Turf
Ornamental Lawns & Turf
Golf Course Turf,
Application Method/Rate in Ibs ai/A
1.4
1.4
1.4
3
3
3
4.1
4.1
4.1
Body Weight (g)
20
180
1000
20
180
1000
20
180
1000
LD50 (mg/kg)
930
930
930
930
930
930
930
930
930
Acute RQ1 (LD50/ft2)
0.78***
0.09
0.02
1.68***
0.19*
0.04
2.28***
0.26**
0.05
1 RQ = App. Rate (Ibs ai/A) * (453.590 mg/Lbs/43,560 ft2/A)
     LD50 mg/kg * Weight of Animal (g) /1000 g/kg

*** exceeds acute high, acute restricted and acute endangered species LOCs.
**  exceeds acute restricted and acute endangered species LOCs.
*  exceeds acute endangered species LOG


               An analysis of the results indicates that for broadcast applications of granular products, avian
       acute high risk, restricted use, and endangered species LOCs are exceeded at application rates equal
       to or above 1.4 Ibs a.i./A for songbirds and small juveniles; endangered species LOG is exceeded for
       upland gamebirds and other mid-sized birds at rates of 3 Ibs a.i./A. and greater; and restricted use
       LOG is exceeded  for the same birds at 4.1 Ibs a.i./A. Large birds are not at risk from exposure to
       granules of iprodione .
                                    iii)
Seed Treatments
               Iprodione is also used an antifungal seed treatment for peas, ornamental trees, ornamental
       herbaceous plants and grasses. Birds may be exposed to pesticides by ingesting treated seeds. They
       also may be exposed by other routes, such as by drinking water contaminated by treated seeds. The
       number of lethal doses (LD50s) that are available within one square foot immediately after application
       (LD50s/ft2) is used as the RQ for treated seeds. Risk quotients are calculated for a 20 g songbird. The
       two tables below assume that the treated seeds are not incorporated into the soil and are available to
       foraging birds. The acute RQs for applications to seed to prevent fungus are in table 48  an 49.
                                                 127

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 Table 48. The Number of Treated Seeds Needed to Reach the Northern Bobwhite Quail LD50 of 930 mg/kg
 for a 0.02 kg Bird.
Seeds/oz
Peas/90
TreesVl420
Zinnia/3200
Tall Fescue/1 11 15
Seeds/Cwt
144,000
18,272,000
5,120,000
17,784,000
A.I. Lb/cwt of seed
0.175
0.1308
0.1308
0.1308
Lbs a.i./Seed
1.22 x 10'6
7.16x 10'9
2.55 x 10'8
7.35 x 10'9
Mg a.i./seed
0.55
0.003
0.012
0.003
LD50 (mg/kg)
930
Birdwt
02
Seeds/LD502
34
6,200
1,550
6,200
 1 1989. Rules for Testing Seeds, Association of Official Seed Analysts, Journal of Seed Technology Vol. 12, No. 3 ;  2 Seeds/LD50 = (LD50 x Body Weight)/Mg a.i. per seed

       This table indicates that: 1) It takes significantly fewer large seeds to reach lethal dose and 2)
A bird can more easily ingest a lethal dose of iprodione by foraging on larger treated seeds (peas) than
on smaller treated seeds.

Table 49. Avian Acute Risk Quotients for Treated Seeds Based on a Northern Bobwhite Quail LDSO of 930 mg/kg
and Weight of a Small Songbird (20g).
Lbs of seed/ A
Peas/220
Trees2/25
Zinnia/200
Tall Fescue/12
Oz of seed/A
3,520
400
3,200
192
No. seeds/oz
90
1,420
3,200
11,115
Seeds/A
316,800
568,000
10,240,000
2,134,080
Seeds//ft2
7
13
235
49
Mg a.i./seed
0.55
0.026
0.0116
0.018
mg a.i./ft2
4.0
0.3
2.7
0.2
LD50/ft2
0.22
0.02
0.15
0.01
1 USDA 1966-Yearbook of Agriculture - Seeds
2 1989. Rules for Testing Seeds, Association of Official Seed Analysts, Journal of Seed Technology Vol.12, No. 3
       This table indicates that the LOG for restricted use is exceeded only for pea seeds, and the
LOG for risks to endangered species is exceeded for pea and zinnia seeds.

                             (b)    Birds—Chronic Risks

                                    i)     Nongranular Applications

       In order to calculate chronic risks, the lower NOEC value from the avian reproduction study
is compared to estimated residues from multiple applications.  The "FATE" program was used to
calculate the EEC values.  The initial concentration was based on the maximum residue value for short
range grass (1 Ib a.i./A equals 240 ppm).  The half-life value of 30 days was taken from the aerobic
soil metabolism study, as foliar degradation studies were not conducted.  Iprodione has over forty
registered  agricultural uses,  but the  application  rates are similar in terms  of rate, number of
applications and interval between applications.  Therefore, the application scenarios used to calculate
the estimated residues do not list specific crops.   Each simulation was run for 120 days, and the
maximum residue and average residue during that  period were used to determine the possibility of
chronic avian risk.  Avian chronic risk quotients based on average residues for multiple, broadcast
applications of non-granular products  are in table 50.
                                          128

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Table 50. Avian Chronic Risk Quotients for Multiple Applications of Nongranular Products (Broadcast) Based
on both the Mallard Duck and Bobwhite Quail NOEC of 300 ppm and Maximum and Average Residues.
Application Rate in Ibs
a.i./A
1.0
1.0
0.5
2.0
4.0
5.45
22
Number of
Applications
4
4
2
1
2
2
2
Application
Interval in Days
7
14
14
n/a
14
14
14
Maximum EEC1 (ppm) and
Average EEC1 (ppm)
766
320
630
311
207
81
480
163
1655
644
2255
878
9101
3543
NOEC (ppm)
300
300
300
300
300
300
300
300
300
300
300
300
300
300
Chronic RQ
(EEC/NOEC)
2.55+
1.07+
2.10+
1.04+
0.69
0.27
1.60+
0.54
5.52+
2.15+
7.52+
2.93+
30.3+
11.80+
1 Assumes degradation using FATE program.
+ Exceeds chronic LOG for nonendangered and endangered species.

       An analysis of the results indicate that for multiple applications of nongranular products of
iprodione that the avian chronic level of  concern  (LOG)  is exceeded at a registered maximum
application rate of 1.0 Ib a.i./A applied 4 times seasonally with 7 to 14 days between applications. The
2.0 Ibs a.i./A rate applied once refers to the use on garlic where the pesticide is applied in-furrow.
Although the  maximum residues for this  use exceed the  LOG,  the  application method reduces
exposure to birds, although the magnitude of this reduction cannot be quantified. The greatest chronic
risk to birds is presented by the rates greater than or equal to 4 Ibs  a.i./A, all of which pertain to use
on turf, ornamental trees and ornamental plants.

       There  currently are no methods to calculate chronic risks to birds from exposure to granular
formulations and seed treatments.
                            (c)
Mammals-Acute Risks
       Estimating the potential for adverse effects to wild mammals is based upon EEB's draft 1995
SOP of mammalian risk assessments and methods used by Fletcher et al. (1994). The concentration
of iprodione in the diet that is expected to be acutely lethal to 50% of the test population (LC50) is
determined by dividing the LD50 value (usually the rat or the mouse LD50) by the % (decimal of) body
weight consumed. A RQ is then determined by dividing the EEC by the derived LC50 value. Risk
quotients are calculated for three separate weight classes of mammals (15, 35, and 1000 g), each
presumed to consume four different kinds of food (grass, forage, insects, and seeds).

       However,  as the LD50 value  for technical iprodione is practically nontoxic, based on a
laboratory mouse LD50 of 3050 mg/kg and a laboratory rat LD50 of 4468 mg/kg, the only application
rates likely to produce residues great enough to present risks to nontarget mammals are those for turf
and ornamental uses. Therefore, for acute and chronic risks from multiple applications of nongranular
                                         129

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       iprodione, only the scenario based on residues for short rangegrass, which represent the "worst case
       scenario" is presented.  The acute RQs for broadcast applications of nongranular products are in table
       51 below.

                                            i)       Nongranular Products

Table 51. Mammalian Acute Risk Quotients for Single Application of Liquid Products (Broadcast) Based on a Mouse
LD50 of 3050 mg/kg.
Site
Agri crops
Garlic
Turf & Ornam.
Turf & Ornam.
Turf & Ornam.
Rate/
in Ibs ai/A
1.0
2.0
4.0
5.45
22.0
Body
Weight (g)
15
35
1000
15
35
1000
15
35
1000
15
35
1000
15
35
1000
% Body
Weight
Consumed
95
66
15
95
66
15
95
66
15
95
66
15
95
66
15
Mouse
LD50
(mg/kg)
3050


3050


3050


3050


3050


EEC/(ppm)
Short Grass
240


480


960


1308


5280


EEC/(ppm)
Forage &
Small Insects
135


270


540


736


2970


EEC/(ppm)
Large Insects
& Seeds
15


30


60


82


330


Acute RQ1
Short
Grass
0.07
0.05
0.01
0.15*
0.10
0.02
0.20**
0.21**
0.05
0.41**
0.28**
0.06
1.64***
1.14***
0.26
Acute RQ
Forage & Small
Insects
0.04
0.03
0.01
0.08
0.06
0.01
0.17*
0.12
0.03
0.23**
0.16
0.04
0.93***
0.64***
0.15
Acute RQ
Large
Insects & Seeds
0.01
0.01
0.00
0.01
0.01
0.00
0.02
0.01
0.01
0.03
0.02
0.00
0.10
0.07
0.02
          EEC (ppm)
    LD50 (mg/kg)/% Body Weight Consumed
* The LOG for acute risk to endangered species is exceeded;
** The LOCs for acute risk to endangered species and restricted use are exceeded;
*** The LOCs for high acute risk, restricted use and acute risk to endangered species have been exceeded.

                  An analysis of the results indicates that for single applications of nongranular products
           of iprodione, the LOCs for acute risk to endangered species is exceeded for application rates
           equal to and greater than 2.0 Ibs a.i./A; the LOG for restricted use is exceeded at rates equal to
           or greater than 4.0 Ibs a.i./A; and the LOG for high acute risk is exceeded at rates equal to or
           greater than 22 Ibs a.i./A.\
                                                     130

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Table 52. Mammalian Acute Risk Quotients for Multiple Applications of Nongranular Products (Broadcast) Based
on a Mouse LD50 of 3050 mg/kg.
Site
Agri. Crops
Agri. Crops
Ornamental
Plants and
Trees
Turf and
Ornamentals
Ornamental
Plants and
Trees
Rate/in Ibs ai/A
1.0
1.0
4.0
5.45
22.0
No. of
Applications
4
4
2
2
2
Application
Interval (Days)
7
14
14
14
14
Body
Weight (g)
15
35
1000
15
35
1000
15
35
1000
15
35
1000
15
35
1000
% Body Weight
Consumed
95
66
15
95
66
15
95
66
15
95
66
15
95
66
15
RatLD50
(mg/kg)
3050
3050
3050
3050
3050
EEC(ppm)
Short Grass
766


630


1655


2255


9101


Acute RQ1
Short Grass
0.24**
0.17
0.04
0.20**
0.14*
0.04
0.52***
0.36**
0.08
0.70***
0.49**
0.11
2.83***
1 97***
0.45
  RQ = EEC (ppm) * % Body Weight Consumed
       LD50 (mg/kg)
* The LOG for acute risk to endangered species is exceeded.
** The LOCs for acute risk to endangered species and restricted use are exceeded.
*** The LOCs for high acute risk, restricted use and acute risk to endangered species have been exceeded.
                   An analysis of the results indicates that for  multiple applications of nongranular
           products of iprodione, the LOCs for restricted use and acute risks to endangered species are
           exceeded for agricultural crops treated with 1.0 Ib  a.i./A; and that the LOCs for high acute
           risk,  restricted  use  and acute  risks to  endangered species are exceeded  for turf and
           ornamentals treated with rates equal to or greater than 4.0 Ibs a.i./A.
                                                   ii)
Granular Products
                   The following table shows the acute risks from exposure to granular products using
          the LD50 /ft2 approach.
Table 53. Mammalian Risk Quotients for Granular Products (Broadcast) Based on a Mouse LD50 of 3050 mg/kg.
Site/ Application Method
Ornamental Lawns & Turf
Ornamental Lawns & Turf
Golf Course Turf
Rate in Ibs ai/A
1.4
1.4
1.4
3
3
3
4.1
4.1
4.1
Body Weight (g)
15
35
1000
15
35
1000
15
35
1000
LD50 (mg/kg)
3050
3050
3050
3050
3050
3050
3050
3050
3050
Acute RQ1 (LD50/ft2)
0.32**
0.14
0.01
0.68***
0.29**
0.01
0.93***
0.40**
0.01
     RQ = App. Rate (Ibs ai/A) * (453.590 mg/Lbs/43,560 ft2/A)
         LD50 mg/kg * Weight of Animal (g) * 1000 g/kg
   * indicates that endangered species LOG has been exceeded.
   ** indicates that both endangered species and restricted use LOCs have been exceeded.
   ***indicates that all three LOCs have been exceeded: endangered species, restricted use, and acute high risk.
                                                     131

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             An analysis of the results indicate that for broadcast applications of granular products,
      mammalian acute high risk, restricted use, and endangered species LOCs are exceeded at
      single application rates equal to or above 3 Ibs a.i./A. Rates less than 3 Ibs a.i./A only exceed
      the LOCs for restricted use and acute risks to endangered species.
                                         iii)
       Seed Treatments
             The use of  iprodione  as  a seed treatment was  thoroughly analyzed for birds.
      Therefore, it will not be repeated extensively in this mammal section.  Iprodione is less toxic
      to mammals than to birds (LD50s of 3050 mg/kg and 930 mg/kg, respectively). The two tables
      for seed treatments indicate that the iprodione-treated pea  seeds present the greatest risk to
      birds.  The pea seeds/LD50 index is 34 for birds.  As iprodione is about 3.3 times more toxic
      to birds than mammals, the pea seeds/LD50 index is equivalent to 112 for mammals. Likewise
      The LD50/square foot index for a small bird (20 grams) is 0.22.  This index converts for a
      similar sized small mammal to a value of 0.06.  This value indicates that the risk of seed
      treatments to small mammals is relatively low.

                    (d)    Mammals-Chronic Risks from Nongranular Products

Table 54. Mammalian Chronic Risk Quotients for Multiple Applications of Nongranular Products (Broadcast)
Based on a Rat NOEC of 500 ppm in a Reproduction Study and Maximum and Average Residues.
Application Rate in Ib
a.i./A
1.0
1.0
0.5
2.0
4.0
5.45
22
Number of
Applications
4
4
2
1
2
2
2
Application
Interval in Days
7
14
14
n/a
14
14
14
Maximum EEC1 (ppm) and
Average EEC1 (ppm)
766
320
630
311
207
81
480
163
1655
644
2255
878
9101
3543
NOEC
(ppm)
500
500
500
500
500
500
500
500
500
500
500
500
500
500
Chronic RQ
(EEC/NOEC)
1.53+
0.64
1.26+
0.62
0.41
0.16
0.96
0.54
3.31+
1.29+
4.51+
1.76+
18.2+
7.09+
1 Assumes degradation using FATE program.
+ Exceeds chronic LOG for nonendangered and endangered species.

              The results indicate that for multiple broadcast applications of nongranular products
       of iprodione the mammalian chronic level of concern is exceeded at registered maximum
       application rates equal to or above 1.0 Ib a.i./A for maximum estimated residues and 4.0 Ibs
       a.i./A for average residues.
                                  (e)
Insects
             Currently, EPA does not assess risk to nontarget insects.  Results of acceptable studies
      are used for recommending appropriate label precautions.  The bee  contact LD50  study
                                            132

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indicates that the iprodione is "relatively nontoxic".  Therefore, precautionary label to protect
bees is not required.

                     (2)   Exposure  and  Risk  to  Nontarget Freshwater Aquatic
                           Animals

       EPA calculated the EECs for iprodione using the GENeric Expected Environmental
Concentration Program (GENEEC). The EECs are used to assess acute and chronic risks to
aquatic organisms.  Acute risk assessments were performed using peak EEC values for single
and multiple applications.  Chronic risk assessments were performed using the 21-day EECs
for invertebrates and fish, as this is the time interval analogous to the exposure periods in the
chronic studies (21 days and 34 days, respectively).

       The  GENEEC  program  uses basic environmental fate data  and pesticide label
application information to estimate the expected EECs following treatment of 10 hectares.
The model calculates the concentration (i.e. EEC) of a pesticide in a one hectare, two meter
deep pond, taking  into account the following: (1) adsorption to soil or sediment (2) soil
incorporation (3) degradation in soil before washoff to a water body and (4) degradation
within the water body.  The model also accounts for direct deposition of spray drift into the
water body  (assumed to be 1% and  5% of the  application rate for ground  and aerial
applications, respectively).  When multiple applications  are permitted the interval between
applications is included in the calculations. Several different intervals between applications
were  used and are indicated in the table below  for each  site that was modeled.  The
environmental fate parameters used in the model for this pesticide are: soil Koc 327, solubility
13 ppm, aerobic soil metabolism half-life 90 days, aerobic aquatic metabolism half-life 21 days,
stable to hydrolysis and photolysis. The Koc value is the average of two soils (sandy loam and
loamy sand) from the equilibrium study.

       The nine listed crops comprise approximately 71 percent of the total active ingredient
applied annually.  For the turf, lawn, and golf course uses, no  limit to the number of
applications nor maximum annual application rates were reported in either the label directions
or the LUIS report. Therefore, it was assumed that the pesticide could be applied year-round
in the southern U.S. and for half the year in the northern U.S.

       Iprodione has one aquatic use, rice. For this use EPA assumes a simple dilution of the
amount applied to a surface acre of water at a depth of six  inches for a peak EEC. In addition,
water residue data from the rice monitoring study  are also used to calculate aquatic risk
quotients.  The methods used in the monitoring  study may  have  underestimated  the
concentrations of iprodione measured during the  course of the  study.   Therefore, risk
quotients calculated with these data likely underestimate the risks that organisms in the rice
regions encounter.
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Table 55. Estimated Environmental Concentrations (EECs) For Aquatic Exposure.
Site
Application Rate x No/Interval (da)
Peak EEC (ppb) 1 4-Day EEC (ppb)
21 - DayEEC (ppb)
56 - Day EEC (ppb)
GENEEC
Peanuts
Almonds
Grapes
Peaches
Potatoes
Onions
Strawberries
Cotton
Turf - Full Year
Turf -Half Year
Rice - Direct
Applic.
Rice - Monitoring
Study
1.0x3/14(0)'
0.5 x 4/14 (A)
1.0 x 4/14 (G)
1.0x4/7 (A)
1.0x4/10 (A)
0.75 x 5/7 (A)
1.0 x 4/10 ((G)
0.15 X 1 (G)
5.45 x 26/14 (G)
5.45 x 13/14 (G)
0.5 x 2/14 (A)
0.5 x 2/14 (A)
70
45
88
98
94
89
92
4
1280
1030
367
121.1 peak(on field)
55.2 peak (off field)
66
42
83
93
89
84
87
4
1210
970


49
31
62
68
66
62
64
3
890
720
—
54.2 (on field)
30 (FW off field)
7.1(SW)
29
19
37
41
40
37
39
2
540
430
—
26.7 (on field)
12 (FW off field)
2.5 (SW)
'(G) = ground application to crop. (A) = aerial application to crop.

                                    (a)    Freshwater Fish

              The highest peak EEC value for agricultural crops treated with iprodione is 98 ppb
       from aerial applications of peaches. When this EEC is compared to the lowest freshwater fish
       LC50 value of 3.1 ppm (channel catfish) the resultant RQ is 0.03, which is below the Levels
       of Concern (LOCs) for high acute risk, restricted use and acute risks to endangered fish
       species. Likewise, the highest 21-day EEC for agricultural crops is 68 ppb, also for peaches.
       The resultant chronic RQ is 0.26, which is below the LOG for chronic risks. Therefore, it can
       be concluded that the agricultural uses of iprodione do not present acute or chronic risks to
       freshwater  fish.

              However, the turf scenarios present acute and chronic risks to freshwater fish. These
       two use patterns plus the rice use are presented in the tables 56.

Table 56.  Risk Quotients for Turf and Rice Scenarios for Freshwater Fish Based On a Channel Catfish LC50
of 3.1 (2.6- 3.6) ppm and a Fathead Minnow NOEC of 0.26 mg/L.
Site/Rate
in Ibs ai/A.
Turf- Full Yr.
Turf- Half Yr.
Rice - Direct App.
Rice - Monitor. Stdy.
Rice - Monitor. Stdy.
No. of Apps
5.45 (26)
5.45(13)
0.5 (2)
0.5 (2)
0.5 (2)
LC50
(ppm)
3.1
3.1
3.1
3.1
3.1
NOEC
(ppm)
0.26
0.26
0.26
0.26
0.26
EEC
Initial/Peak (ppm)
1.28
1.030
0.367
0.121 (field)
0.055 (off field)
EEC
21-Day Ave. (ppm)
0.890
0.720
—
0.054 (field)
0.030 (off field)
Acute RQ
(EEC/LC50)
0.42**
0.33**
0.12*
0.04
0.02
Chronic RQ
(EEC/NOEC)
3.42+
2.77+
—
0.02
<0.01
* indicates that only the endangered species acute LOG has been exceeded.
** indicates that both the restricted use and endangered species acute LOCs have been exceeded.
+ indicates that the chronic LOG for nonendangered and endangered species has been exceeded.

              The RQs from the table indicate that the restricted use LOG is exceeded for the turf
       and rice (direct application) scenarios.  The chronic risk RQs are also exceeded for both turf
       scenarios.
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                                   (b)     Freshwater Invertebrates

             Unlike the freshwater fish results, LOCs were exceeded for a number of use scenarios
      for the freshwater invertebrates. Therefore, all scenarios listed in the EEC table are included
      in table 57 below.

Table 57. Risk Quotients for Freshwater Invertebrates Based On a Water Flea ECSO of 0.24 ppm and a Water
Flea NOEC of 0.17 ppm.
Site/Rate in Ibs ai/A
(No. of Apps.)
Peanuts/1.0 (3)
Almonds/0.5 (4)
Grapes/1. 0(4)
Peaches/1. 0(4)
Potatoes/1.0 (4)
Onions/0.75 (5)
Strawberries/1.0 (4)
Cotton/0. 15(1)
Turf- Full Yr.5.45 (26)
Turf- Half Yr.5.45 (13)
Rice - Direct Applic.0.5 (2)
Rice - Monitor. Stdy. 0.5 (2)
Rice - Monitor. Stdy. 0.5 (2)
LC50
(ppm)
0.24
0.24
0.24
0.24
0.24
0.24
0.24
0.24
0.24
0.24
0.24
0.24
0.24
NOEC
(ppm)
0.17
0.17
0.17
0.17
0.17
0.17
0.17
0.17
0.17
0.17
0.17
0.17
0.17
EEC
Initial/Peak (ppm)
0.070
0.045
0.088
0.098
0.094
0.089
0.092
0.004
1.28
1.030
0.367
0.121 (field)
0.055 (off field)
EEC 2 1-Day
Average (ppm)
0.049
0.031
0.062
0.068
0.066
0.062
0.064
0.003
0.890
0.720
—
0.054 (field)
0.030 (off field)
Acute RQ
(EEC/LC50)
0.29**
0.19**
0.37**
0.41**
0.39**
0.37
0.38**
0.02
5.33***
4.29***
1.53***
0.50***
0.23**
Chronic RQ
(EEC/NOEC)
0.29
0.18
0.36
0.40
0.39
0.36
0.38
0.03
5.24+
4.24+
—
0.32
0.18
* indicates that only the endangered species acute LOG has been exceeded.
** indicates that both the restricted use and endangered species acute LOCs have been exceeded.
+ indicates that the chronic LOG for nonendangered and endangered species has been exceeded.

             The RQs from the table indicate that cotton is the only use that does not produce risk
      quotients that exceed any LOCs.  Both turf scenarios and the peak concentration at the edge
      in the rice field exceed the LOCs for high acute risk, restricted use and  acute risk to
      endangered  species.   The other crops listed  exceed  the  LOCs for restricted use and
      endangered species acute risks.

              Only the turf scenarios produced RQs high enough to exceed the LOG for chronic
      risks to freshwater invertebrates.

                           (3)    Exposure and Risk to Estuarine and Marine Animals

                                  (a)     Fish

             The highest peak EEC value from aerial applications of peaches is 98 ppb. When this
      EEC is compared to the estuarine fish LC50 value of 7.7 ppm the resultant RQ is 0.01, which
      is below the Levels of Concern (LOCs) for high acute risk, restricted use and acute risks to
      endangered fish species. The two turf uses produce EECs of 1280 ppb and  1030 ppb, which
      result in RQs of 0.17 and 0.13, respectively, exceeding the LOG for acute risks to endangered
      estuarine/marine fish and restricted use.
                                            135

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                                   (b)    Invertebrates

              Unlike the estuarine fish results, LOCs were exceeded for a number of use scenarios
       for the freshwater invertebrates. Therefore, all scenarios listed in the EEC table are included
       in table 58 below.

Table 58. Risk Quotients for Estuarine/Marine Invertebrates Based On a Mysid LC50/EC50 of 680 ppb and a
MysidNOECof3.5ppb.
Site/Rate in Ibs ai/A
Peanuts
Almonds
Grapes
Peaches
Potatoes
Onions
Strawberries
Turf- Full Yr.
Turf- Half Yr.
Rice - Direct Applic.
Rice - Monitor. Stdy.
Rice - Monitor. Stdy.
No. of Apps.
1.0(3)
0.5 (4)
1.0(4)
1.0(4)
1.0(4)
0.75 (5)
1.0(4)
5.45 (26)
5.45(13)
0.5 (2)
0.5 (2)
0.5 (2)
LC50
(Ppb)
680
680
680
680
680
680
680
680
680
680
680
680
NOEC
(Ppb)
3.5
3.5
3.5
3.5
3.5
3.5
3.5
3.5
3.5
3.5
3.5
3.5
EEC Initial/Peak
(Ppb)
70
45
88
98
94
89
92
1280
1030
367
121 (field)
55 (off field)
EEC 2 1-Day
Average(ppb)
49
31
62
68
66
62
64
890
720
—
54 (field)
7.1 (off field)
Acute RQ
(EEC/LC50)
0.10**
0.07*
0.13**
0.14**
0.14**
0.13
0.14**
1.88***
1.51***
0.54***
0.18**
0.08*
Chronic RQ
(EEC/NOEC)
14.00
8.90
17.70
19.40
18.90
17.70
18.30
254.3+
205.7+
—
15.40
2.03
* indicates that only the endangered species acute LOG has been exceeded.
** indicates that both the restricted use and endangered species acute LOCs have been exceeded.
***indicates that the high acute risk, restricted use and endangered species LOCs have been exceeded.
+ indicates that the chronic LOG for nonendangered and endangered species has been exceeded.

              The table indicates that with regard to acute risks to estuarine invertebrates, use of
      iprodione on cotton does not exceed any  acute LOCs;  use on almonds exceeds only the
      endangered species LOG; and the other agricultural crops exceed both the endangered species
      and the restricted use LOCs. Both turf scenarios and the use on rice exceed the high risk,
      restricted use and endangered species LOCs.

              All  uses exceed the LOG for  chronic risks to nonendangered  and endangered
      estuarine/marine invertebrates.

                            (4)    Exposure and Risk to Nontarget Plants

                                   (a)    Aquatic Plants

              Exposure to nontarget aquatic plants may  occur  through runoff or spray drift from
      adjacent treated sites or directly from the rice use.  For  iprodione the aquatic plant  risk
      assessment for acute high risk to nonvascular plants is done by comparing the EECs used in
      the aquatic animal risk  assessment to the EC50  value for green algae  and marine diatoms.
      Risks to endangered non-vascular plants are done using the NOEC values.  To date there are
      no known non-vascular plant species on the endangered species list. The risks to endangered
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      and nonendangered vascular plants cannot be determined as there are currently no valid data
      for this group of aquatic plants. Acute RQs for non-vascular plants are in table 59.

Table 59. Acute Risk Quotients for Aquatic Plants based upon a Green Algae (Kirchneria subcapitate) ECSO
of 2.0 mg a.i./L and a NOEC of 0.14 mg/L and a Marine Diatom EC50 of 0.33 mg/L and a NOEC of 0.03 mg/L.
Site/Rate in Ibs ai/A
Agric. Crops
Turf - Full Year
Turf -Half Year
Rice - Direct Appl.
Rice - Monitor. Study
Rice - Monitor. Study
No. Of Apps.
1.0(4)
5.45 (26)
5.45(13)
0.5 (2)
0.5 (2)
0.5 (2)
EEC (ppm)
0.098
1.28
1.03
0.367
0.121 (field)
0.055 (off field)
Species
algae diatom
algae diatom
algae diatom
algae diatom
algae diatom
algae diatom
EC50
2.0
0.33
2.0
0.33
2.0
0.33
2.0
0.33
2.0
0.33
2.0
0.33
NOEC
1.4
0.03
1.4
0.03
1.4
0.03
1.4
0.03
1.4
0.03
1.4
0.03
RQ (EEC/
EC50)
0.05
0.30
0.64
3.88
0.52
3.12
0.18
1.11
0.06
0.37
0.03
0.17
RQ (EEC/
NOEC)
0.07
3.27
0.92
42.7
0.74
34.3
0.26
12.2
0.09
4.03
0.04
1.83
             RQs for the freshwater algae are below all levels of concern.  RQs for the marine
       diatom exceed the LOG for high acute risk for the turf uses and direct application to rice
       fields. All uses exceed the endangered species LOG; however, no marine diatoms are listed
       with USFWS as "endangered". EPA does not perform assessments for chronic risk to aquatic
       plants.

                    (b)     Exposure and Risk to Endangered Species

             Endangered species are likely to be impacted acutely and chronically as follows:

             Acute risks — birds and mammals from granular applications to lawns and turf at rates
       > 1.4 Ib a.i./A;  mammals from single applications of nongranular products at rates > 2.0 Ib
       a.i./A and multiple applications at rates > 1.0 Ib a.i./A;  freshwater fish from  multiple
       applications to turf and single and multiple applications to rice; estuarine fish from multiple
       applications to turf; freshwater and estuarine invertebrates from all uses but cotton.

             Chronic risks  — birds and mammals from multiple applications at > 1.0 Ib a.i./A for
       all crops;  freshwater fish and invertebrates from multiple applications to turf; estuarine
       invertebrates from all uses.

             Currently there are no estuarine  invertebrates on the Endangered and Threatened
       Species  listings from US Fish and Wildlife Service.

             The Agency has developed a program (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 will eliminate the adverse impacts. At
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present, the program is being implemented on an interim basis as described in a Federal
Register notice (54 FR 27984-28008, July 3, 1989), and is providing information to pesticide
users to help them protect these species on a voluntary basis. As currently planned, the final
program will call for label modifications referring to required limitations on pesticide uses,
typically as  depicted in county-specific bulletins or by other site-specific mechanisms as
specified by state partners.  A final program, which may be altered from the interim program,
will be described in a  future Federal Register notice.  The Agency is not imposing label
modifications  at this time through the RED.  Rather, any requirements for product  use
modifications  will  occur in the future under the Endangered Species Protection Program.

              4.      Risk Characterization

      The risk quotients on the previous pages indicate that the greatest acute and chronic
risks to wildlife and  aquatic  organisms,  including aquatic plants, are the granular  and
nongranular uses on turf and ornamentals. The primary reason is that iprodione is applied at
very high rates and with great frequency on these sites.

      The database for iprodione is largely complete. The major routes of dissipation are
hydrolysis in neutral and alkaline environments  (half-lives pH 7 = 4.7 days; pH 9 = 27
minutes) and microbial  degradation under both aerobic and anaerobic conditions. The overall
result of these mechanisms of dissipation appears to indicate that iprodione has low to
intermediate persistence in the environment.  The results obtained in the field confirm the
expected low persistence of iprodione (t1/2=3-7 days).

      A degradate of toxicological concern, 3,5-dichloroaniline (RP-32596), was found in
several of the laboratory studies in low to moderate amounts. Its persistence and mobility are
not well understood at this time. Additional studies are needed (aerobic soil metabolism  and
batch equilibrium) to help characterize the fate of this toxic degradate and to better estimate
its expected environmental concentrations  in both surface water and ground water.

      Despite the fact that iprodione is mobile to highly mobile in some soils, it is unlikely
that it will leach to ground water because  of its rapid degradation in the environment.  In
addition, because iprodione is typically applied as a foliar treatment, degradation/metabolism
on the plant surface and/or absorption by plants will further mitigate the potential for ground
water contamination.

      The RQ values for avian  acute risk (single application of nongranular products)
indicate that the uses of iprodione on turf and ornamentals may exceed the acute LOCs for
high risk. However, these calculated risk quotients are the upward bounds of risk, with the
actual level of risk being lower. As iprodione is nontoxic and as the toxicity value cannot be
precisely expressed, it is reasonable to conclude that nongranular iprodione is not an acute
risk to birds.
                                     138

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             Although the agricultural uses are not a high risk to fish and wildlife and aquatic plants,
       the use on rice demonstrates a high risk to freshwater and estuarine invertebrates and aquatic
       plants. Rice agriculture is a unique practice in that the chemical is applied aerially to water-
       covered fields which adjoin waterways rich in aquatic life. The physical arrangement of the
       fields and waterways permits direct  application  of aerially  applied pesticides  into the
       waterways when the fields are treated.

             For seed treatments, iprodione-treated pea seeds present the greatest risk to birds.  The
       peas seeds/LD50 index is 34 seeds. As iprodione is about 3.3 times more toxic to birds than
       mammals, the pea seeds/LD50 index  is equivalent to 112  for mammals.  Likewise, the
       LD50/square foot index for a small bird (20 grams) is 0.22. This index converts for a similar
       sized small mammal to a value of 0.06.  This value indicates that the risk of seed treatments
       to small mammals is relatively low.

             Of the many variables [soil type, bird stresses, bird behavior (nesting, mating, feeding
       young)] that can influence seed selection and amount of consumption, the significance of the
       depth that a seed is planted is unknown.  Planting depth appears to be related to the size of
       the seed. Larger seeds are planted deeper:  pea seeds 1-2 inches, trees 1 inch, flowers 1A inch,
       and grass seeds near or on the surface.  If we assume deeper seeds are less likely to be found
       and eaten, it is less likely that birds will ingest enough of iprodione-contaminated seeds to
       exceed the LD50.  On the other hand, small seeds like tall fescue are basically laying on the
       surface and can be easily found, but a foraging bird would need to eat many contaminated
       small seeds to exceed the LD50. Another factor, which is difficult to quantify, is the spillage
       of treated seeds on the ground when planters are filled or pulled up. All these factors indicate
       that birds can be exposed to contaminated seeds in the fields, but behavior and environmental
       conditions can exacerbate or lessen the hazard to birds.

             Iprodione is listed as an endocrine disrupter in the Special Report on Environmental
       Endocrine Disruption: An  Effects Assessment and Analysis, EPA, 1997.  It is an anti-
       androgen, chemically related to vinclozolin, with  similar effects noted in the ovary, testis and
       sex gland of rodents. Altered parental behavior and reduced embryo survival were observed
       in avian reproduction studies.  In addition, reproduction impairment was also observed in
       invertebrates.
IV.   RISK MANAGEMENT AND REREGISTRATION DECISION

      A.     Determination of Eligibility

             Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
      relevant  data concerning an  active ingredient, whether products  containing  the  active
      ingredients 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 iprodione active ingredients. The Agency has completed

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its review of these generic data, and has determined that the data are sufficient to support
reregi strati on of all products containing iprodione.  Appendix B identifies the generic data
requirements that the Agency reviewed as part of its determination of reregi strati on eligibility
of iprodione, and lists the submitted studies that the Agency found acceptable.

       The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of iprodione and to determine that iprodione can be used without resulting in
unreasonable adverse effects to humans and the environment. The Agency therefore finds that
at this time all products containing iprodione as the active  ingredient are eligible for
reregi strati on.   The reregi strati on of particular products is addressed in Section V of this
document.

       The Agency made its reregistration eligibility determination based upon the target data
base required for reregistration, the current guidelines for conducting acceptable studies to
generate such data, published scientific literature, etc. and the data identified in Appendix B.
Although the Agency has found that most uses of iprodione are eligible for reregistration,  it
should be understood that the Agency may take appropriate regulatory action, and/or require
the submission of additional data to support the registration of products containing iprodione,
if new information comes to the Agency's attention or if the data requirements for registration
(or the guidelines for generating such data) change.

       1.     Eligibility Decision

       Based  on the reviews of the generic data for the active ingredient in this case, the
Agency has sufficient information on the health effects and on  the environmental fate and
effects of iprodione.  The Agency has determined that iprodione products, if labeled and used
as specified in this Reregistration Eligibility Decision, will not pose unreasonable  risks or
adverse effects to humans or the environment.  Under the Food Quality and Protection Act
of 1996, the Agency has determined that there is reasonable certainty that no  harm will result
to infants and children or the general population from aggregate exposure to iprodione.
Therefore, the Agency concludes that all  products containing  iprodione  are  eligible for
reregistration.

       2.     Eligible and Ineligible Uses

              The Agency has determined that existing uses of iprodione are  eligible for
reregistration  subject to conditions imposed in the RED.   These include removal  of all
residential  uses of  iprodione  (residential turf,  residential  ornamentals  and residential
vegetable/small fruit gardens) from product registrations due to cancer risk concerns.  Also,
to protect handlers of granular  iprodione products, removal of belly grinder  application
method from iprodione product registrations. Lastly, to mitigate risks to birds, removal of
herbaceous ornamental seed treatment from all iprodione registrations.
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       Rhone-Poulenc has already requested these changes to the iprodione registrations. In
order for an iprodione product to be eligible for reregistration, these uses must be removed
from the label.

B.     Regulatory Position

       The following is a summary of the regulatory positions and rationales for iprodione.
Where labeling revisions are  imposed, specific language is  set forth in Section V of this
document.

       1.      Food Quality Protection Act Findings

              a.      Determination of Safety for U.S. Populations

       EPA has determined that the established tolerances for iprodione meet the safety
standards under the FQPA amendments to Section 408 (b)(2)(D) for the general population.
In reaching this determination, EPA has considered available information on the aggregate
exposures from non-occupational sources, food and drinking water, as well as the possibility
of cumulative effects from iprodione and other chemicals with a similar mechanism of toxicity.

       Five aggregate exposure and risk assessments were conducted for iprodione. These
risk assessments reflect non-occupational exposures and  include combined exposures to
iprodione through food and water in the diet, and through  homeowner uses. They are: (1)
acute dietary; (2) chronic dietary; (3) cancer; (4) short-term; and, (5) intermediate-term risk
assessments.

                            Acute Aggregate Risk

       The aggregate  acute dietary risk estimate includes exposure to iprodione residues in
foods and water.   Iprodione uses are not expected to significantly impact ground water,
surface water has concentrations of a few parts per billion, and the drinking water level of
concern for acute effects of iprodione is below the Agency's level of concern.  For the acute
dietary exposure and risk assessment, the toxic endpoint selected for risk assessment was the
NOEL of 20  mg/kg/day based on decreased anogenital  distance (AGD) in male  offspring
observed in the developmental study in rats, in which the LOEL was  120 mg/kg/day.  The
FQPA safety factor is applied for acute dietary risk assessment for only females 13+ because
the endpoint (decrease AGD) is  an in utero effect occurring during prenatal exposures.

                     Chronic (Non-Cancer) Aggregate  Risk

       The chronic aggregate risk assessment for Iprodione includes risk estimates associated
with dietary exposure through  food, water,  and registered residential uses.  Anticipated
residues and percent crop-treated data for commodities with published tolerances result in an
exposure to Iprodione through food which represents up to 1.6% of the chronic FQPA RfD
for the most exposed subpopulation in the U.S. (non-nursing infants, <1 year old). Exposure
to all other groups  is less than or equal to 1% of the chronic FQPA RfD.

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       Chronic aggregate risk from Iprodione in the diet and drinking water associated with
registered uses of iprodione is not of concern. Estimated average concentrations of Iprodione
in ground water were not available for comparison against DWLOC values; however, based
on Iprodione's physical/chemical characteristics and available,  but limited monitoring data,
iprodione is not expected to significantly impact ground water.

       No chronic exposure scenarios for residential uses of iprodione were identified;
therefore, no chronic exposure was included in the aggregate risk estimate.

                     Cancer Aggregate Risk

       Without risk mitigation measures in place, combined exposure and the risk estimates
for  each of the residential  exposure  scenarios plus dietary exposure to iprodone residues
results in cancer risk estimates that are all greater than 10"6. The first step in reducing the
cancer aggregate risk is to make ineligible for reregi strati on all  those residential uses which
are  greater than 10"6.  Based  on the current risk assessment, Rhone-Poulenc has agreed to
cancel all residential uses of iprodione. With these mitigation measures in place cancer risks
from residential uses of iprodione are expected to be zero.

       For dietary cancer risk, with no risk mitigation measures in place, the upper bound
dietary cancer risk estimate (3.9 x 10"6) exceeds EPA's level of concern. With risk mitigation
measures in place, the upper bound dietary cancer risk estimate is approximately 1.8 x 10"6 and
is within the range the Agency generally considers negligible for excess life-time cancer risk.
This risk estimate was based the new use pattern per the risk mitigation measures in this
document, which is based on a refined estimate of dietary exposure using the most recent
percent crop-treated data (1995) and anticipated residue data from monitoring programs
(USDA's PDF) and field trials.

       Iprodione residues are not expected to exceed the Agency's drinking water level of
concern for either acute and chronic exposure..

                     Short-term Aggregate Risk

       Aggregate risk estimates associated with short-term risk includes exposures to average
residues of iprodione in the diet (food and water) and inhalation exposure (1 to 7 days in
duration) through the residential application of iprodione. The resulting risk represents 3.6%
of the acute FQPA RfD for the U.S. population representing the most exposed population of
adult males and females.  It is assumed that children and infants  do not apply pesticides.  The
Agency believes that iprodione's impact on drinking water will not affect the aggregate short-
term risk  significantly.  Therefore, the Agency concludes with reasonable  certainty  that
residues of iprodione in drinking water (when considered along with exposure from food and
residential uses) would not result in an unacceptable short-term  aggregate human health risk
estimate at this time.
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                     Intermediate-term Aggregate Risk

       Aggregate risk estimates associated with intermediate-term risk includes exposures to
average residues of Iprodione in the diet (food and water) and inhalation Exposure (7 days to
several months in duration) through the residential application of Iprodione. The resulting risk
represents 9.5% of the chronic FQPA RfD for the U.S.  population representing the most
exposed population of adult males and females.  It is assumed that children and infants do not
apply pesticides.  The Agency believes that Iprodione's impact on drinking water will not
affect the aggregate intermediate-term risk significantly.  Therefore, the  Agency concludes
with reasonable certainty that residues of Iprodione in drinking water (when considered along
with Exposure from  food and  residential uses) would not  result  in an unacceptable
intermediate-term aggregate human health risk estimate at this time. Subject to the conditions
imposed by this RED are met by the registrant, the Agency concludes that aggregate risks for
the general population resulting from iprodione uses are not of concern.

                     Cumulative Risk for 3.5-Dichloroaniline

       Although at present  the  Agency is working to  define a policy for applying the
information in its files concerning common mechanism issues to most risk assessments, there
are pesticides as to which the common mechanism issues can be resolved. These pesticides
include pesticides that are lexicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide shares a common mechanism
of activity with other substances) and pesticides that produce a common toxic metabolite (in
which case common mechanism of activity will be assumed).

       Iprodione is structurally related to vinclozolin and procymidone, which belong to the
imide class.  Each of these three pesticides can metabolize to 3,5-dichloroaniline (3,5-DCA).
 FQPA requires EPA to estimate  cumulative  risk from consumption of food and water
containing 3,5-DCA derived from iprodione, vinclozolin,  and procymidone.

       3,5-DCA is not a registered pesticide; therefore, there are no FIFRA toxicology data
for this compound. In the past, EPA has used the Qt* for p-chloroaniline (PCA) to assess the
carcinogenic  risk for other  structurally related  chloroanilines.  The EPA  policy  on
chloroanilines   specifies  that chloroaniline   metabolites  should  be  considered  to  be
lexicologically equivalent to PCA unless there is sufficient evidence that the metabolite is not
carcinogenic.

       The  cumulative  carcinogenic risk estimate for  consumption of food and wine
containing residues of 3,5-DCA as a result of use of iprodione, vinclozolin, and procymidone
is 9.5 x  10"7  This may be considered to be a conservative estimate. Metabolism studies for
iprodione and vinclozolin were used to  estimate the amount of 3,5-DCA present in various
commodities by using Total Radioactive Residues (TRRs) to convert iprodione or vinclozolin
exposures to 3,5-DCA exposures. There is another uncertainty in the risk estimate in that a
surrogate Qt* is being used for 3,5-DCA.  However, due to the structural similarities of 3,5-

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DCA and PCA (parachloroaniline), EPA believes that for 3,5-DCA, the use of the PC A Qt*
represents an upper-bound estimate. Based on this risk estimate, at this time this risk estimate
is within the range the Agency generally considers negligible for excess life-time cancer risk.

       Further refinement to the DCA exposure estimates are being conducted in conjunction
with the vinclozolin RED. This is being done to reflect risk mitigation measures proposed for
vinclozolin.  The end-result of these proposed mitigation measures will be a decrease in DCA
exposure, resulting in a lower cancer risk estimate.

              b.     Determination of Safety for Infants and Children

       EPA has determined that the established tolerances for iprodione meet the safety
standard under the FQPA amendment to section 408(b)(2)(C) for infants and children.  The
safety determination for infants and children considers the factors noted above for the general
population, but also takes into account the possibility of increased dietary exposure due to the
specific consumption patterns of infants and children,  as well as the possibility of increased
susceptibility to toxic effects of iprodione residues in this population subgroup.

       In determining whether or not infants and children are particularly susceptible to toxic
effects from iprodione residues, EPA considered the completeness of the data  base for
developmental and reproductive  effects, the nature  of the effects observed, and  other
information.

       The decision to apply an additional safety factor to ensure the protection of infants and
children from  exposure to iprodione, as required by the FQPA, was  elevated to the EPA
Office of Pesticide Programs Division Directors from the FQPA Safety Factor Committee.
The Division Directors met April 7, 1998, and  determined that the additional 10X FQPA
safety factor for enhanced sensitivity to children (as required by FQPA) should be reduced to
3X.  The rationale for this decision is based on: (1) no  enhanced susceptibility to rats and
rabbits in developmental studies and a two-generation  reproduction study in rats; (2) the
critical endpoint for acute dietary risk assessment (decreased AGD) was seen at a high dose
(120 mg/kg/day) and there were only marginal differences in the degree of decreased AGD
between the doses 20 mg/kg/day (2.44), 120 mg/kg/day (2.32) and 250 mg/kg/day (2.10) thus
indicating the "true" NOEL could be higher than the one established at 20 mg/kg/day; (3) the
proposed mode of action of Iprodione  is disruption of testosterone biosynthesis; (4) the use
of a realistic dietary exposure data (refined using monitoring data and percent crop treated);
and, (5) the endpoints selected for both the acute (AGD) and the chronic (histopathology of
male reproductive system) risk assessments are based on developmental/reproductive effects.

       EPA estimates that iprodione residues in the diet of infants and children account for
under 1% of the RfD.  The aggregate exposure from all sources of iprodione account for
under 1 % of the RfD  for infants and children.  Therefore, the Agency concludes that
aggregate risks for infants and children resulting from uses of iprodione are not of concern.
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       In deciding to continue to make reregi strati on determinations during the early stages
of FQPA implementation, EPA recognizes that it will be necessary to make decisions relating
to FQPA before the implementation process is complete.  In making these early, case-by-case
decisions, EPA does not intend to set broad precedents for the application of FQPA to its
regulatory determinations. Rather, these early decisions will be made on a case-by-case basis
and will not bind EPA as it proceeds with further policy development and any rulemaking that
may be required.

       If EPA determines, as a result of this later implementation process, that any of the
determinations described in this RED are no longer appropriate, the Agency will consider itself
free to pursue whatever action may be appropriate, including but not limited to reconsideration
of any portion of this RED.

2.     Risk Mitigation

       To lessen human health risk, residential risk, worker risk, and ecological and water-
quality risks posed by iprodione, Rhone-Poulenc  has voluntarily requested  the following
mitigation measures.

 •  To protect human health from acute dietary and carcinogenicity concerns:

              For iprodione use on strawberries,  increase the pre-harvest interval from 0-
              days to up to but not after first flower. In addition, reduce the tolerance for
              strawberries to the limit of quantitation (0.05 ppm).

              For iprodione use on all stone fruit (apricots, cherries, nectarines, plums, and
              prunes), increase the pre-harvest interval from 7-days to up to but not after
              petal fall (approximately 45 - 90-day pre-harvest interval). In addition, reduce
              the tolerances for all stone fruit, including peaches, to limit of quantitation
              (0.05 ppm).

              For iprodione use on table grapes (fresh,  cooked, canned, juice,  raisin or
              otherwise; mitigation does not include wine  and sherry grapes), reduce the
              application rate  from 4 times per  season to  one application per season at
              early- to mid-bloom. Tolerances remain unchanged consistent with this RED
              (10 ppm).

       Based on a monte carlo and ORES model runs conducted by both the Agency and
 Novigen, Inc., these risk mitigation measures result in an acceptable acute dietary MOE of
 351  for females  13+ (acceptable MOE =  300), and  an upperbound cancer risk of
 approximately  1.8 x  10"6, which is within the range that the Agency currently  views as
 acceptable. Field trial studies to measure the new  residue-levels in these food commodities
 (strawberries, stone  fruit)  based on these  new pre-harvest intervals  is  required for
 confirmatory purposes.

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       Furthermore, with these mitigation measures in place, the drinking water level of
concern is expected to be below the Agency's level of concern and thus have a negligible
contribution for both the acute dietary risk and aggregate cancer risk for iprodione. To
confirm this, the Agency requests that a surface water monitoring study be submitted.

       Also in regard to these acute dietary/dietary cancer risk mitigation measures, the
Agency notes that the registrant, Rhone-Poulenc, Inc.,will be submitting new mechanistic
studies which may or may not alter the human cancer risk assessment for Leydig cell tumors.
Rhone-Poulenc contends that this newly submitted data could potentially show that the Q*
calculated for the rat Leydig cell tumors would not be appropriate for risk quantification, and
that a non-threshold (MOE) approach or a revised Q* approach using the mouse liver tumor
would be more appropriate. Rhone-Poulenc argues that such a change would potentially
resolve most risk issues for iprodione with no, or minimal, mitigation.  The Agency will
continue to analyze this new data, and if those data are found to be accurate, the Agency will
revisit these risk mitigation measures.

       Lastly, it should be noted that these risk mitigation measures will bring iprodione to
within its limit for  aggregate  dietary and cancer risk, thus allowing for additional uses,
providing that those new uses have negligible risk contribution, such as iprodione uses on
cotton.

•  To protect residential users from cancer risks:

       Rhone-Poulenc has requested to cancel all residential uses of iprodione. These uses
are:
              Iprodione residential use on turf;.

              Iprodione residential uses on vegetables/small fruit gardens;

              Iprodione residential uses on ornamentals;

•  To protect non-target organisms:

              Limit the maximum number of applications on non-residential turf, lawn, golf
              course, ornamental trees, and ornamental plants from "unlimited" to 6 per
              year, with the maximum annual application of up to but no more than 24 Ibs.
              active ingredient.

              Except for use  of the product on  golf courses, include label  warnings
              requiring  a vegetative buffer  strip  of at least  25-feet for application of
              iprodione adj acent to water bodies such as lakes, reservoirs, rivers, permanent
              streams, marshes or natural ponds, estuaries, and commercial fish ponds.
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                  For use on golf courses, the following statement will be included on the label:
                  "for golf courses only, do not apply to turf cut higher than 1" on golf holes
                  where water bodies are present."

                  Include label  warnings  to prevent  application of iprodione when wind
                  direction is toward aquatic area.
                  Rhone-Poulenc  has  requested  to cancel  all herbaceous ornamental seed
                  treatment uses of iprodione, based on risks to birds.
                  For rice use only, continue to include endangered species restrictions in the
                  state of Arkansas (for the fat  pocketbook pearly mussel and its  habitat).

To protect handlers of liquid formulations (mixers/loaders/applicators):

                  In aerial/chemigation application, mixers and loaders must must wear double-
                  layer clothes, chemical-resistant gloves and dust/mist respirators.

                  In ground boom application, in orchard airblast sprayer application, and in
                  professional application  using  a low-pressure/high-volume hand sprayer,
                  mixers and loaders must wear chemical-resistant gloves.  Applicators using a
                  low-pressure/high-volume handsprayer must wear chemical-resistant gloves.

                  In high-pressure hand wand application, mixers, loaders, and applicators must
                  wear  double-layer  clothes,   chemical-resistant  gloves,  and  dust/mist
                  respirators.

                  In low-pressure hand wand application, mixers, loaders, and applicators must
                  wear chemical-resistant gloves.

                  In backpack sprayer application, mixers, loaders, and applicators must wear
                  double-layer clothes, chemical-resistant gloves, and dust/mist respirators.

    •  To protect handlers ofwettable powder formulations (mixers/loaders):

                  In aerial/chemigation application (all  agricultural  uses), mixers and loaders
                  must use water-soluble bags.

                  In ground boom application, mixers and  loaders must wear double-layer
                  clothes, chemical-resistant gloves, and dust/mist respirators.

                  In orchard airblast application, and in professional application to turf using a
                  low-pressure/high-volume  hand  sprayer,  mixers and loaders  must wear
                  chemical-resistant gloves.

    •  To protect handlers of dry flow able formulations  (mixers/loaders):

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              In chemigation application to turf, mixers and loaders must must wear double-
              layer clothes, chemical-resistant gloves, and dust/mist respirator.

              In ground boom application, mixers and loaders must wear double-layer
              clothes and chemical-resistant gloves.

•  To protect handlers of granular formulations (mixers/loaders/applicators):
              Belly-grinder application risks  are greater than  10"4 with maximum PPE,
              therefore, application using a belly grinder is ineligible for reregistration.
              Using push-type spreader application,  loaders and applicators must wear
              chemical-resistant gloves.

•  To protect workers:

              The restricted-enty interval is increased from 12-hours to 48-hours for use of
              iprodione on grapes and ornamentals, and to 24-hours for all other iprodione
              uses.  Early entry workers must wear coveralls, chemical-resistant gloves,
              shoes, and socks.  The 48-hour and the 24-hour restricted-entry intervals are
              default intervals based on (1) the lack of data regarding dislodgeable residues
              for iprodione; and,  (2)  the  Agency's general  concern regarding post-
              application exposure from iprodione.  The Agency will revisitthese restricted-
              entry interval  decisions when dislodgeable residue data  is  available  and
              reviewed (October 2000).

       3.      Tolerance Reassessment Summary

       Tolerances for iprodione are published in 40 CFR ง180.399.  Tolerances  had been
established in/on almonds, apricots, beans, blueberries, boysenberries, broccoli, caneberries,
carrots, cherries, currants, garlic, ginseng, grapes, kiwi, lettuce, onions, nectarines, peaches,
peanuts, plums, potatoes, raspberries, rice and strawberries. The available data support the
established tolerances with  the  proposed reassessments:  revoke raspberries; lower the
tolerance on grapes from 60 ppm to 10 ppm, and on peaches from 20 ppm to 0.05  ppm; and
raise the tolerance on prunes from 20 ppm to 80 ppm,  poultry fat from 3.5 ppm to 7 ppm,
poultry liver from 5 ppm to 7 ppm, and poultry meat  by-products from 1 ppm to 7 ppm.
Based on the dietary risk mitigation measures in this RED, there will be interim tolerances set
for strawberries and all stone fruits at the level of quantitation (0.05 ppm).

       Tolerances for residues of iprodione in/on plant commodities [40 CFR ง180.399 (a),
(c), and (d)(l), and 40 CFR ง180.31], processed food commodities [40 CFR ง185.3750], and
processed feed commodities [40  CFR ง186.3750] are expressed in terms of the combined
residues of  Iprodione parent, its isomer, and  one metabolite.  Following  evaluation of
acceptable plant metabolism studies, the Agency has determined that the iprodione residues
of concern that warrant regulation in/on plant commodities should continue to be those that
comprise the current tolerance expression for plants.
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       Tolerances for residues of iprodione in livestock commodities [40 CFR ง 180.399 (b)]
are expressed in terms of the combined residues of iprodione parent, its isomer, and two
metabolites, all expressed as ilprodione equivalents.  Following evaluation of acceptable
livestock metabolism studies, The Agency has determined that the Iprodione residues of
concern that warrant regulation in livestock commodities should continue to be those that
comprise the current tolerance expression for livestock.

       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 changes (OPPTS GLN 860.1000), iprodione tolerances for certain RACs which have
been removed from the livestock feeds  table need  to be revoked.   Some commodity
definitions must also be corrected.  A  summary of Iprodione tolerance reassessments is
presented in Table 60.

       Tolerances Listed Under 40 CFR ง180.399 (a)

       Pending label amendments for some crops, adequate data are  available to reassess the
established tolerances for the following commodities, as defined:  almonds, hulls; almonds,
nutmeat; beans,  dried, vine hay;  beans, dry; beans, forage; beans,  succulent; blueberries;
boysenberries; broccoli; caneberries; carrots; currants; garlic;  ginseng; grapes; kiwi fruit
(imported); lettuce;  onions, dry bulb; peaches; peanuts; peanut forage; peanut hay; peanut
hulls; potatoes; raspberries; rice, grain; rice,  and straw.

       Explanations and rationales for tolerance adjustments of certain RACs are presented
below.

       Bean forage and hay:  Provided  labels are amended such that  Iprodione use on
       cowpeas is prohibited, no tolerances are required on the forage and hay of beans.
       Therefore, the established tolerances for "beans, dried, vine hay" and "beans, forage",
       each established at 90 ppm, should be revoked.

       Blueberries  and currants:   The available field trial data  for blueberries will be
       translated to currants.

       Boysenberries and raspberries:   The established tolerances  of 15  ppm  for
       boysenberries and raspberries should be revoked since Iprodione residues on these
       crops, as a result of registered uses, are covered by the  established tolerance for
       caneberries.

       Ginseng:  The appropriate RAC for ginseng is dried root (Table 1, OPPTS  GLN
       860.1000). A Section 408 tolerance of 4 ppm for "ginseng, root, dried" should be
       established concomitant with the revocation of the tolerance  of 2 ppm for "ginseng".

       Grapes:  Review of residue  chemistry data determined that appropriate tolerance
       levels are 10 ppm for grapes  and 15 ppm for the processed commodity raisins.

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       Peanut, hay: The registrant has submitted label amendments to prohibit the feeding
       of peanut hay to livestock in order to mitigate risk.  The Agency previously
       recommended that the established tolerance for peanut hay should be revoked. The
       established tolerances for peanut forage and hulls should be revoked since these items
       are not considered significant livestock feed items (Table 1, OPPTS GLN 860.1000).

                    Tolerances Listed Under 40 CFR ง180.399 (b)

       Following evaluation of acceptable livestock metabolism studies, the Agency has
determined that the residues to be regulated in livestock should continue to be the parent, its
isomer RP-30228, and metabolites RP-32490  and RP-36114 which comprise the current
tolerance  expression for livestock.  With the evaluation that livestock feeding data are
acceptable, and with the completion of Phase 5 review of livestock feed items, tolerances can
be reassessed for livestock commodities. If an acceptable enforcement method is developed
to determine individual tolerance residues rather than common moieties, it may be appropriate
to lower tolerance levels for livestock commodities.

                    Tolerances Listed Under 40 CFR ง180.399 (V)

       Adequate data are available to reassess the established tolerance for Chinese mustard.

                    Tolerances Listed Under 40 CFR ง180.399 (dฅl)

       The time-limited tolerance for cottonseed, established under PP#2F4111 (61 FR
19845, 5/3/96), expired on March 15, 1997; therefore, this tolerance can not be reassessed.
The Agency notes that the registrant filed a proposal (62 FR 3691, 1/24/97) for an extension
of this time-limited tolerance which was denied.

                    Tolerances Listed Under 40 CFR ง180.31

       Temporary tolerances for tangelos and tangerines, established under PP#3G4210,
expired in 1997; therefore, these tolerances can not be reassessed. The Agency notes that the
registrant  filed  a petition proposal  (PP#3G4210) for  an extension of these temporary
tolerances (62 FR 3691,  1/24/97) which was denied.

                    Tolerances Listed Under 40 CFR ง185.3750

       There are no processed commodities associated with ginseng (Table 1, OPPTS GLN
860.1000). Therefore, the established food additive tolerance for "ginseng, dried" should be
revoked concomitant with the establishment a Section 408 tolerance of 4 ppm for the
combined Iprodione residues of concern in/on "ginseng,  root, dried".   The tolerance for
raisins should be changed to 15 ppm.
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                           Tolerances Listed Under 40 CFR ง186.3750
              The established feed additive tolerances for peanut soapstock, grape dry pomace, and
       raisin waste should be revoked since these items have been removed from Table 1 (OPPTS
       GLN 860.1000) because they are not considered to be significant livestock feed items.  The
       Agency has proposed the revocation of the established feed additive tolerance for peanut
       soapstock (60 FR 49142, 9/21/95).  Current tolerance levels for rice hulls and bran are
       appropriate.
                            Pending Tolerance Petitions

              PP#4F4281:  Rhone-Poulenc  has submitted this petition for the establishment of
       tolerances for the combined residues of Iprodione, its isomer, and one metabolite in/on canola
       (rape seed).  This petition is currently in reject status because of deficiencies pertaining to
       storage stability and residue data.

Table 60.  Tolerance Reassessment Summary for Iprodione.
Commodity
Current
Tolerance (ppm)
Tolerance
Reassessment
(ppm)
Comment/
[Correct Commodity Definition]
Tolerances Listed Under 40 CFR ง180.399 (a)
Almonds, hulls
Almonds, nutmeat
Apricots
Beans, dry
Beans, succulent
Beans, dried, vine hay
Beans, forage
Blueberries
Boysenberries
Raspberries
Broccoli
Caneberries
Carrots
Cherries (sour)
Cherries (sweet)
Currants
Garlic
Ginseng
Grapes
2.0
0.3
20.0
2.0
2.0
90.0
90.0
15.0
15.0
15.0
25.0
25.0
5.0
20.0
20.0
15.0
0.1
2.0
60.0
2.0
0.3
0.051
2.0
2.0
Revoke
Revoke
15.0
Revoke
Revoke
25.0
25.0
5.0
0.051
0.051
15.0
0.1
Replace
10.0

[Almonds, nutmeats]
Reassessed tolerance based on risk mitigation
negotiations at time of issuance of RED.


Provided labels are amended such that Iprodione use
on cowpeas is prohibited, these tolerances should be
revoked.

Iprodione residues on boysenberries and raspberries
are covered by the established tolerance for
\Caneberry (blackberry and raspberry) subgroup] .

[Caneberry (blackberry and raspberry) subgroup]

Reassessed tolerance based on risk mitigation
negotiations at time of issuance of RED.
The available blueberry data can be translated to
currants.

The appropriate RAC for ginseng is dried root (Table
1, OPPTS GLN 860.1000). Concomitant with the
revocation of tolerance for "ginseng", a Section 408
tolerance of 4.0 ppm on [ginseng, root, dried] should
be established.

                                           151

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Table 60. (continued).
Commodity
Kiwi fruit
Lettuce
Nectarines
Onions, dry bulb
Peaches
Peanuts, nutmeat
Peanut hay
Peanut forage
Peanut hulls
Plums
Potatoes
Prunes
Rice grain
Rice straw
Strawberries
Current
Tolerance (ppm)
10.0
25.0
20.0
0.5
20.0
0.5
150.0
150.0
7.0
20.0
0.5
20.0
10.0
20.0
15.0
Tolerance
Reassessment
(ppm)
10.0 2
25.0
0.05 '
0.5
0.05
0.5
Revoke
Revoke
0.05 '
0.5
0.05 '
10.0
20.0
0.05 '
Comment/
[Correct Commodity Definition]
[Kiwifruits]

Reassessed tolerance based on risk mitigation
negotiations at time of issuance of RED.
[Onions, bulb]
Reassessed tolerance at 0.05 ppm based on voluntary
deletion of all post harvest uses and label
amendments

Label amendments to prohibit the feeding of peanut
hay to livestock have been submitted.
These items are no longer considered significant
livestock feed items (Table 1, OPPTS GLN
860.1000).
Reassessed tolerance based on risk mitigation
negotiations at time of issuance of RED.

Reassessed tolerance based on risk mitigation
negotiations at time of issuance of RED.
[Rice, grain]
[Rice, straw]
Reassessed tolerance based on risk mitigation
negotiations at time of issuance of RED.
Tolerances Listed Under 40 CFR ง180.399 (b)
Cattle, fat
Cattle, kidney
Cattle, liver
Cattle, meat
Cattle, meat byproducts (mbyp)
(except kidney and liver)
Eggs
Goats, fat
Goats, kidney
Goats, liver
Goats, meat
Goats, mbyp (except kidney and
liver)
Hogs, fat
Hogs, kidney
Hogs, liver
Hogs, meat
0.5
3.0
3.0
0.5
0.5
1.5
0.5
3.0
3.0
0.5
0.5
0.5
3.0
3.0
0.5
0.5
3.0
3.0
0.5
3.0
1.5
0.5
3.0
3.0
0.5
3.0
0.5
3.0
3.0
0.5















                                               152

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Table 60. (continued).
Commodity
Hogs, mbyp (except kidney and
liver)
Horses, fat
Horses, kidney
Horses, liver
Horses, meat
Horses, mbyp (except kidney
and liver)
Milk
Poultry, fat
Poultry, liver
Poultry, meat
Poultry mbyp (except liver)
Sheep, fat
Sheep, kidney
Sheep, liver
Sheep, meat
Sheep, mbyp (except kidney
and liver)
Current
Tolerance (ppm)
0.5
0.5
3.0
3.0
0.5
0.5
0.5
3.5
5.0
1.0
1.0
0.5
3.0
3.0
0.5
0.5
Tolerance
Reassessment
(ppm)
3.0
0.5
3.0
3.0
0.5
3.0
0.5
7.0
7.0
1.0
7.0
0.5
3.0
3.0
0.5
3.0
Comment/
[Correct Commodity Definition]
















Tolerances Listed Under 40 CFR ง180.399 ฉ
Chinese mustard
15.0
15.0 | [Mustard, Chinese]
Tolerance Listed Under 40 CFR ง180.399 (d)(l)
Cottonseed
0.10
N/A, Expired
Tolerance expired in 1997. Therefore, it can not be
reassessed at this time.
Tolerances Listed Under 40 CFR ง180.31
Tangelos
Tangerines
3.0
3.0
N/A, Expired
N/A, Expired
Tolerances expired in 1997 and therefore can not be
reassessed at this time.
Tolerances Listed Under 40 CFR ง185.3750
Ginseng, dried
Raisins
4.0
300
Revoke
15.0
There are no processed commodities associated with
ginseng (Table 1, OPPTS GLN 860.1000).

Tolerances Listed Under 40 CFR ง186.3750
Grapes, pomace, dry
Raisin waste
Rice bran
Rice hulls
Soapstock
225.0
300.0
30.0
50.0
10.0
Revoke
Revoke
30.0
50.0
Revoke
These items are no longer considered significant
livestock feed items (Table 1, OPPTS GLN
860.1000).


This item is no longer considered a significant
livestock feed item (Table 1, OPPTS GLN
860.1000).
1   These tolerances are contingent upon submission of confirmatory field trial data based on risk mitigation and label changes.
2   There are no U.S. registrations for Kiwi fruits as of 12/11/96; the currently established tolerance for kiwi fruit is an import
tolerance.
                                                        153

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             4.
Codex Harmonization
             The Codex Alimentarius Commission has established maximum residue limits (MRLs)
       for iprodione residues in/on various commodities (see Guide to Codex Maximum Limits For
       Pesticide Residues, Part 2, FAO CX/PR, 4/91). The Codex MRLs are expressed in terms of
       iprodione per se. Harmonization of the Codex MRLs with the U.S. tolerances is not feasible
       at this time because of differences in the U.S. tolerance and Codex MRL expressions.
       Although incompatible, a numerical comparison of the Codex MRLs and the corresponding
       reassessed  U.S. tolerances  is presented in Table 61.

Table 61. Codex MRLs and applicable U.S. tolerances.
Commodity, As Defined
Almonds
Apple
Barley
Beans (dry)
Beans (dry)
Blackberries
Broccoli
Carrot
Cherries
Common bean (pods and/or immature seeds)
Cucumber
Cucumber
Currants,Black, Red, White
Garlic
Grapes
Kiwi fruits
Lettuce, Head
Lettuce, Leaf
Onion, Bulb
Onion, Bulb
Peach (post-harvest treatment)
Peach
Pear
Peppers, Sweet
Plums (including prunes)
Pome fruits
Rape seed
Raspberries, Red, Black
Raspberries, Red, Black
Rice, Husked
MRL, mg/kg '
0.2
10
2
0.2
0.1
30
25
10
10
2
5
2
5
0.1
10
5
10
25
0.1
0.2
10
10
10
5
10
5
0.5
5
30
3
Step
5/8
CXL2
5/8
CXL2
5/8
5
5/8
5
5
5
CXL2
5/8
CXL2
CXL2
CXL3
CXL3
CXL3
5/8
CXL2
5/8(a)
CXL2
5/8(a)
CXL2
CXL2
CXL2
5/8(a)
5/8
CXL2
5/8(a)
CXL
Reassessed U.S. Tolerance, ppm
0.3
-
--
2.0
2.0
25.0
25.0
5.0
0.05 (*)
-
--
-
15.0
0.1
10.0
10.0
25.0
25.0
0.5
0.5
revoke
0.05(*)
-
-
0.05 (*)
-
--
25.0
25.0
Rice grain, 10.0
                                          154

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Commodity, As Defined
Rice, Husked
Strawberry
Sugar beet
Sunflower seed
Tomato
Witloof chicory (sprouts)
MRL, mg/kg '
10
10
0.1 (*)
0.5
5
1
Step
5
CXL
5/8(a)
5/8
CXL4
CXL3
Reassessed U.S. Tolerance, ppm
Rice grain, 10.0
0.05 (*)
-
--
-
--
'An asterisk (*) signifies that the MRL was established at or about the limit of detection.
2Deletion was recommended (1994 JMPR). Where there are multiple entries forthe same crop/group, the current MRL will be canceled upon replacement.
'Confirmed (1994 JMPR). "Withdrawal was recommended (1994 JMPR); on hold awaiting data from France.
              5.
Reference Dose (RfD)
              The Agency's RfD/Peer Review Committee established a Reference Dose (RfD) of
       0.06 mg/kg/day based  on a NOEL of 6.1 mg/kg/day established in a combined chronic
       toxicity/carcinogenicity   study  (MRID  42637801;  MRID  42787001)  based  on
       histopathological lesions in the male reproduction system and effects on the adrenal glands
       in males at 12.4 and in females at 16.5 mg/kg/day (LOEL).  The NOEL was adjusted with an
       uncertainty factor of 300 (10X  for inter-species  extrapolation,  10X for  intra-species
       variability, and 3X for FQPA considerations). The chronic FQPA RfD was determined to be
       0.02 mg/kg/day.
              6.
Cancer Risk Assessment
              The EPA Cancer Assessment Review Committee (CARC) in accordance with the
       EPA Proposed Guidelines for Carcinogen Risk Assessment (April 10, 1996), classified
       Iprodione as a "likely"  (B2)  human  carcinogen based on  the combined hepatocellular
       adenomas/ carcinomas in mice and testicular tumors in male rats with a linear low-dose
       extrapolation approach and a 3/4s interspecies scaling factor for human risk characterization.
       For the combined hepatocellular adenomas/ carcinomas, the Q!*S are 8.7 x 10"3 for the male
       mouse and 5.07 x 10"3 forthe female mouse. Forthe Ley dig cell tumors in male rats, the Qt*
       is 4.39 x 10"2 was established.  The CARC determined that of these, the most potent Qt* of
       4.39 x 10"2 should be used for cancer risk assessments. Therefore, the Qt* of 4.39 x 10"2 was
       used for estimating carcinogenic risk.

              7.     Endocrine Disruption

              The  available toxicology data for Iprodione suggest that it is associated with
       endocrine effects. However, the extent of these effects and the mode of action  are not yet
       fully understood.   The  Agency continues to investigate  this matter.  A  special  rat
       developmental toxicity study with Iprodione showed decreased anogenital distance (AGO)
       at the  mid and high dose level (120 and 250 mg/kg/day). However, there were only marginal
       differences in AGD between the dose levels. In addition, Iprodione is structurally related to
       Vinclozolin and Procymidone,  which are associated with endocrine disruption.
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       EPA is required to develop  a screening program to determine whether  certain
substances (including all pesticides and inerts) "may have an effect in humans that is similar
to an effect produced by a naturally occurring estrogen, or such other endocrine effect..." The
Agency is currently working with interested  stakeholders,  including other government
agencies, public interest groups, industry and research scientists in developing a screening and
testing program and a priority setting scheme  to implement this program. Congress has
allowed 3 years from the passage of FQPA (August 3, 1999) to implement this program. At
that time, EPA may require further testing of this active ingredient and end use products for
endocrine disrupter effects.

       8.     Occupational Exposure

       The Worker Protection Standard (WPS^)

       EPA's  Worker Protection Standard for Agricultural Pesticides (WPS)  affects all
pesticide products whose labeling reasonably permits use in the commercial or research
production of agricultural  plants on any farm,  forest, nursery, or greenhouse.  In general,
WPS products had to bear WPS-complying labeling when sold or distributed after April 21,
1994. The WPS labeling requirements pertaining to personal protective equipment (PPE),
restricted-entry intervals (REI),  and notification are interim.  These requirements are to be
reviewed and revised, as appropriate,  during reregi strati on and other Agency  review
processes. At this time all registered uses of iprodione are within the scope of the WPS.

              a.      Handler Exposure and Risk

       For each end-use product, personal protective equipment and engineering  control
requirements for pesticide handlers are set during reregi strati on as follows:

        !      Based on risks posed to handlers by the active ingredient, EPA may establish
              active-ingredient specific (active ingredient specific) handler requirements for
              end-use products containing that active ingredient. If such risks are minimal,
              EPA may  choose  not to establish  active  ingredient specific  handler
              requirements.

        !      EPA establishes handler PPE requirements for most end-use products, based
              on each product's acute toxicity  characteristics.

        !      If active ingredient specific requirements have been established, they must be
              compared to the PPE specified for the end-use product. The more stringent
              choice  for each  type of PPE (i.e., body wear, hand protection, footwear,
              eyewear, etc.) must be placed on the label of the end-use product. Engineering
              controls are considered more stringent than PPE requirements.

       EPA is establishing active-ingredient specific requirements for some occupational
handlers for iprodione.  The cancer risks to handlers from combined dermal and inhalation

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exposures exceeded 10"4 for most scenarios, although all exposures are less than 10"4 with
additional personal protective equipment and/or engineering controls.  The Agency has
determined that risk to handlers resulting from short-term and intermediate-term exposures
are acceptable, provided appropriate risk mitigation measures are taken for each formulation
type.

       Granular Formulations: The Agency has determined that cancer risks to handlers
of granular formulations will be acceptable with addtional PPE and risk mitigation.  Belly-
grinder application risks are greater than 10"4 with maximum PPE, therefore, application using
a belly grinder is ineligible for reregi strati on. Using push-type spreader application, loaders
and applicators must wear chemical-resistant gloves.

       Liquid Formulations:  The Agency has determined that risks to handlers of liquid
formulations will be adequately mitigated with the use of and personal protective equipment.
In aerial/chemigation application, mixers and loaders must must wear double-layer clothes,
chemical-resistant gloves and dust/mist respirators.  In ground boom application, in orchard
airblast sprayer application, and in professional application using a low-pressure/high-volume
hand sprayer, mixers and loaders must wear chemical-resistant gloves.  Applicators using a
low-pressure/high-volume handsprayer must wear chemical-resistant gloves. In high-pressure
hand wand application, mixers, loaders, and applicators must wear double-layer clothes and
chemical-resistant  gloves.  In low-pressure  hand wand application, mixers,  loaders,  and
applicators must wear chemical-resistant gloves. In backpack sprayer application, mixers,
loaders, and applicators must wear double-layer clothes, chemical-resistant gloves,  and
dust/mist respirators.

       Wettable Powder Formulations:  The Agency has determined that risks to handlers
of wettable-powder formulations will  be adequately mitigated with the use of engineering
controls and personal protective equipment. In aerial/chemigation application (all agricultural
uses), mixers and loaders must use water-soluble bags. In ground boom  application, mixers
and loaders  must wear double-layer clothes,  chemical-resistant gloves,  and  dust/mist
respirators. In orchard airblast application, and in professional application to turf using a low-
pressure/high-volume hand sprayer, mixers and loaders must wear chemical-resistant gloves.

       Dry Flowable Formulations:   The Agency has determined that risks to handlers of
dry-flowable formulations will be adequately mitigated with the use of personal protective
equipment.  In chemigation application to turf, mixers and loaders  must must wear double-
layer  clothes, chemical-resistant gloves, and  dust/mist  respirator.   In  ground boom
application, mixers and loaders must wear double-layer clothes and chemical-resistant gloves.

              b.     Post-Application Exposure and Risk

       Restricted-entry intervals, early-entry PPE. and "double " notification:
       The interim Worker Protection Standard (WPS) restricted-entry intervals (REIs) for
agricultural workers are based solely on the acute dermal toxicity and skin and eye irritation
potential of the active ingredient. In addition, the WPS retains two types of REIs established

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by the Agency before the promulgation of the WPS: (1) product-specific REIs established on
the basis of adequate data, and (2) interim REIs that are longer than those that would be
established under the WPS.

       The WPS prohibits routine entry to perform hand labor tasks  during the REI and
requires PPE to be worn for other early-entry tasks that require contact with treated surfaces.

       "Double" notification is the statement on the labels of some WPS pesticide products
requiring employers to notify workers about pesticide-treated areas orally as well as by
posting of the treated areas. The interim WPS "double" notification requirement was imposed
if the active ingredient is classified as toxicity category I for acute dermal toxicity or skin
irritation potential.

       During the reregi strati on process, EPA establishes REI's, early-entry PPE, and double
notification requirements based on consideration of all available relevant information about
the active  ingredient, including  acute toxicity,  other  adverse  effects,  epidemiological
information, and post-application data. EPA is establishing a 48-hour REI for iprodione use
on  grapes  and ornamental uses,  and a 24-hour REI for all other  iprodione uses.  The
following early-entry PPE for all in-scope WPS uses  of products  containing iprodione:
coveralls, chemical-resistant gloves, socks, and shoes.   EPA has determined that double
notification is not required.

       The post-application exposure and risk assessment indicates that risks, specifically
cancer-risks, to post-application (reentry) workers should be acceptable provided entry is
postponed  until at least 48-hours for grapes and ornamentals, and 24-hours for all other
iprodione uses.  The Agency also determined that early-entry personal protective equipment
consisting of coveralls, chemical-resistant gloves, and socks plus shoes would be adequately
protective,  if workers must enter during the restricted-entry interval as  permitted under the
Worker Protection Standard.

              c.      Other Labeling Requirements

       The Agency is also requiring other use and safety information to be placed on the
labeling of all end-use products containing iprodione. For the specific labeling statements,
refer to Section V of this document.

       9.     Ecological Effects Risk Management

       In general, the risk assessment shows various levels of concern (LOG) regarding avian
risk and mammalian risk from broadcast applications of granular and nongranular products
used on turf, ornamental trees and ornamental plants. In addition, most agricultural uses
present acute and chronic risks of varying levels to endangered and nonendangered aquatic
organisms,  with turf and rice demonstrating the higher risks.  In general,  the risks to
invertebrates are greater than the risks to fish. The turf and rice uses present high acute risks
for nonvascular aquatic plants.  To reduce risks to nontarget organisms, the Agency will limit

                                     158

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       the maximum number of applications on turf, lawn, golf course, ornamental trees, and
       ornamental plants from "unlimited" to 6  per year; at a maximum annual active ingredient
       application of 24 Ibs..  In addition, include label warnings requiring a vegetative buffer strip
       of at least 25-feet for application of iprodione adjacent to water bodies such as lakes,
       reservoirs, rivers, permanent streams, marshes or natural ponds, estuaries, and commercial
       fish ponds, except for golf courses. For use on golf courses, the following statement will be
       included on the label: "for golf courses only, do not apply to turf cut higher than 1" on golf
       holes where water bodies are present."  Include label warnings to prevent application of
       iprodione when wind direction is toward aquatic area;  Also, use of iprodione for herbaceous
       ornamental seed treatment is ineligible for reregistration, thus reducing all risk quotients for
       seed treatments  below levels of concern; and, for rice  use only, continue to include
       endangered species restrictions in the state of Arkansas (for the fat pocketbook pearly mussel
       and its habitat).

              10.    Spray Drift  Advisory

              The Agency has been working with the Spray Drift Task Force, EPA Regional Offices
       and State Lead Agencies for pesticide regulation to develop the best spray drift management
       practices.  The Agency is now requiring  interim measures that must be placed on product
       labels/labeling as specified in Section V.  Once the Agency completes its evaluation of the
       new data base submitted  by the Spray Drift Task Force, a membership of U.S. pesticide
       registrants, the Agency may impose further refinements in spray drift management practices
       to further reduce off-target drift and risks associated with this drift.

              11.    Endangered Species Program

              The  Agency has developed a  program (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 will eliminate the adverse
       impacts. At present, the program is being implemented on an interim basis as described in
       Federal Register Notice 54 FR 27984-28008 (July 3, 1989), and is providing information to
       pesticide users to help them protect these species on a voluntary basis. As currently planned,
       the final program will call for label modifications referring to required limitations on pesticide
       uses, typically as depicted  in county-specific bulletins or by other site-specific mechanisms as
       specified by state partners. A final program, which may be altered from the interim program,
       will be described in a future Federal Register Notice. The Agency is not imposing label
       modifications at  this time through the RED.  Rather, any requirements for product-use
       modifications will occur in the future under the Endangered Species Protection Program.
V.     ACTIONS REQUIRED OF REGISTRANTS

              This section  specifies  the  data  requirements  and responses necessary for the
       reregistration of both manufacturing-use and end-use products.
                                           159

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A.     Manufacturing-Use Products

       1.     Additional Generic Data Requirements

       The generic data base supporting the reregi strati on of iprodione for the above eligible
uses has been reviewed and  determined to be substantially complete.  For confirmatory
purposes, the following information will need to be submitted:

•      Pre and/or Post-Natal Exposure Study
       [GLN83-3(a); OPPTS 870.3700]
       The 1998 Hazard Identification Review Committee (HIARC) determined that there
       are  outstanding questions  with  regard to postnatal exposure that remain to be
       addressed in light of the observed effects of iprodione on the testes and its proposed
       mode of action (disruption of testosterone biosynthesis).  Iprodione has been shown
       to alter anogenital distances in male fetuses following exposure during late gestation
       and there is evidence of toxicity to the male reproductive organs in chronic rat studies.
       Also, no data are available on  the effects of iprodione on sperm count,  motility or
       morphology in rats or other species.  Therefore, the HIARC concluded that an
       assessment  of effects on the  male reproductive system following pre/post-natal
       exposure is  required.

•      UV/Visible Absorption for the Pure Active Ingredient
       [OPPTS 830.7050]
       There is currently no core data for UV/visible absorption for the iprodione PAL

•      Density for  the Technical Grade Active Ingredient
       [GLN 63-7; OPPTS 830.7300];
       There is currently no core data for density for the iprodione TGAI.

•      Residue Analytical Methods
       [GLN 171-4(d);  OPPTS 860.1340]

       The Agency will consider alternative methods developed for residue confirmation as
       the enforcement methods;  the registrant will develop and validate  (including the
       appropriate independent laboratory validations) and LC/MS method of analysis for
       parent, RP46190 and RP30228 in crop commodities.

•      Product Chemistry Reports
        [GLN 61/62; OPPTS 830.1550, 830.1600,  830.1670,  830.1700,  830.1750,  and
       830.1800];
       Product chemistry reports need  to be submitted to fulfill product  chemistry data
       requirements for the revised manufacturing process.

•      Aerobic Soil Metabolism [GLN 162-1]; Leach/Adsorp/Desorption [GLN 163-1]


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All environmental fate data requirements for iprodione are  satisfied, except that
information on the toxic degradate 3,5-dichloroaniline (RP32596) is required. 3,5-
dichloroaniline was observed at high concentrations in the laboratory experiments, but
was not monitored in the field. Its persistence and mobility are not well understood
at this time. Additional aerobic metabolism and batch equilibrium studies are needed
to help characterize the fate of this toxic degradate and to better estimate its expected
environmental concentrations in both surface water and ground water.

Confined Rotational Crop Study
[GLN165-1; OPPTS 860.1850];
There is currently no core data for the confined rotational crop study. The Agency
previously advised that depending on crops and plantback intervals chosen, residues
in rotational crops would be expected to increase dietary exposure to iprodione
residues. Also, during a recent review of a petition for use on cotton, the Agency
required that rotations be restricted to those crops for which primary iprodione
tolerances were already established.  This study would confirm these data.

Estimation of Dermal/Inhalation Exposure
[GLN 231; OPPTS 875.1100 [GLN232; OPPTS 875.1300];
There are currently data gaps for two handler  scenarios under occupational and
residential exposure. There are no chemical-specific or Pesticide Handler's Exposure
Database (PHED) baseline data for applying iprodione with a low pressure/high
volume hand gun to turf grass, and there are no chemical-specific or PHED data for
mixing/loading/applying iprodione as a dip treatment.

Aquatic Plant Growth Study [GLN 122-2]
The guideline requirement for aquatic plant growth is currently only partially fulfilled.
The results of the Tier II water studies indicate that the requirement for a study
conducted with the vascular plant, Lemna gibba, is still outstanding.  As the label has
application rates up to 22 Ibs. active ingredient, the registrant must either test Lemna
up to this rate (or the limit of solubility), or establish an EC50 value for this plant. The
studies conducted with Navicula and Anabaena do not need to be repeated, as tests
with these aquatic plants are not required to support the uses of fungicides.

Crop Field Trial Studies (strawberries, stone fruit)
[GLN 171-4 (k); OPPTS 860.1500]
These  confirmatory studies are  required based  on the risk mitigation measures
involving new pre-harvest intervals for strawberries and stone fruit. This information
will give the Agency true residue more accurate estimates for subsequent monte carlo
and DEEM analyses.  The registrant must also submit a formal report on the Novigen
Monte Carlo Analsysis submitted September 1998.

Surface Water Monitoring Study (Special Study)
                              161

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       This confirmatory  study  is required to  replace existing modeled surface-water
       monitoring data with more accurate data,  and to  enhance known surface water
       monitoring data.  If, with the submission of this data, the drinking water level of
       concern for iprodione is exceeded, the  Agency will  require further mitigation
       measures.   This surface water monitoring study is  considered a non-guideline, or
       "special study," and as such will be forwarded to the registrant in a separate Data
       Call-in after review and clearance by the Office of Management and Budget (OMB).

       2.      Labeling Requirements for Manufacturing-Use Products

       To remain in compliance with FIFRA, manufacturing use product (MP) labeling must
be revised to comply with all current EPA regulations, PR Notices and applicable policies.
The MP labeling must bear the following  statement under Directions for Use:

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

       "This product is not registered for use at residential sites. "

       An MP registrant may, at his/her discretion, add one of the following statements to
an MP label under "Directions for Use" to permit the reformulation of the product for a
specific use or all  additional uses  supported by a formulator or user group:

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

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

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

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       been made. Registrants 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 study MRID numbers should be  cited according to the instructions in the
       Requirement Status and Registrants Response Form provided for each product.

       2.     Labeling Requirements for End-Use Products

       The labels and labeling of all products must comply with EPA's current regulations
and requirements as specified in 40 CFR ง156.10 and other applicable notices.

             a.     PPE  and  Engineering Control  Requirements  for Pesticide
                    Handlers

       For sole-active-ingredient end-use products that contain iprodione:

       !     Revise the  product labeling to adopt  the handler personal  protective
             equipment/engineering control requirements  set forth in this section.
       !     Remove any conflicting PPE requirements on the current labeling.

       For multiple-active-ingredient end-use products that contain iprodione:

       !     Compare  the  handler personal  protective  equipment/engineering control
             requirements set forth in this section to the requirements on  the current
             labeling.

       !     Retain the  more  protective  requirements.  (For  guidance  on  which
             requirements are considered more protective, see PR Notice 93-7.)

             b.     Products Intended Primarily for Occupational Use

                    (1)    Active-Ingredient    Specific   Engineering   Control
                           Requirements

       EPA is  establishing active-ingredient specific engineering  controls for  some
occupational uses of iprodione end-use  products.

       For wettable powder formulations:

       "For aerial/chemigation application, mixers and loaders are required to use water-
       soluble bags.  The  water-soluble bags must be used in a manner that meets the
       requirements listed in the Worker Protection Standard (WPS) for agricultural
       pesticides (40 CFR 170.240)."
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                    (2)    Active-Ingredient   Specific   Personal   Protective
                           Equipment Requirements

       EPA is establishing active-ingredient  specific  personal  protective  equipment
requirements for all occupational uses of iprodione end-use products.

       For liquid formulations:

       "For aerial/chemigation application, mixers and loaders must wear:
       — double-layer clothes,
       — chemical-resistant gloves*,
       — socks plus shoes, and
       — dust/mist respirator."

       "For ground-boom application,  in orchard airblast sprayer application, and in
       professional application to turf using a low-pressure/high-volume hand sprayer,
       mixers and loaders must wear:
       — long-sleeved shirt and long pants,
       — chemical-resistant gloves*, and
       — socks plus shoes."

       "For low-pressure/high-volume handsprayer application, applicators must wear:
       — long-sleeved shirt and long pants,
       — chemical-resistant gloves*, and
       — socks plus shoes."

       "For low-pressure hand wand application, mixers, loaders, and applicators must
       wear:
       - long-sleeved shirt and long-pants,
       - chemical-resistant gloves*, and
       - shoes plus socks."

       "For high-pressure hand wand anad backpack sprayer application, mixers and
       loaders, and applicators must wear:
       — double-layer clothes,
       — chemical-resistant gloves*,
       — socks plus shoes, and
       — dust/mist respirator."

       "For other handling activities and in case of a spill or other emergency exposure,
       handlers must wear:
       — coveralls over long-sleeved shirt and long pants,
       — chemical-resistant gloves*,
       — chemical-resistant footwear, and
       — chemical-resistant apron when cleaning equipment."
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*For the glove statement, use the statement established for iprodione through the instructions in
Supplement Three of PR Notice 93-7.

For wettable powder formulations:

For ground-boom application, mixers and loaders must wear:
- double-layer clothes,
- chemical-resistant gloves*,
- socks plus shoes, and
- dust/mist respirator."

For orchard airblast application, and in professional application to turf using a
low-pressure/high-volume  hand sprayer, mixers and loaders must wear:
- double-layer clothes,
- chemical-resistant gloves*, and
- socks plus shoes."

*For the glove statement, use the statement established for iprodione through the instructions in
Supplement Three of PR Notice 93-7.

For dry flowable formulations:

"For chemigation application,  mixers and loaders must wear:
— double-layer clothes,
— chemical-resistant gloves*,
— socks plus shoes, and
— dust/mist respirator."

"For ground-boom application, mixers, loaders, and applicators must  wear:
- double-layer clothes,
- chemical-resistant gloves*, and
- shoes plus socks."

*For the glove statement, use the statement established for iprodione through the instructions in
Supplement Three of PR Notice 93-7.

For granular formulations:

"For push-type spreader application, mixers, loaders, and applicators must wear:
- long-sleeved shirt and long pants,
- chemical-resistant gloves*, and
- shoes plus socks."

*For the glove statement, use the statement established for iprodione through the instructions in
Supplement Three of PR Notice 93-7.
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              c.     Determining PPE Labeling Requirements for End-use Products
                    Containing This Active Ingredient

       The PPE that would be established on the basis of the acute toxicity category of the
end-use product must be compared to the active-ingredient specific personal protective
equipment specified above. The more protective PPE must be placed on the product labeling.
For guidance on which PPE is considered more protective, see PR Notice 93-7.

              d.     Products intended for Residential Use

       Rhone-Poulenc has voluntarily requested to cancel all residential uses of iprodione .

              e.     Placement in Labeling

       The personal protective equipment requirements must be placed on the end-use
product labeling in the location specified in PR Notice 93-7, and the format and language of
the PPE requirements must be the same as is specified in PR Notice 93-7.

              f.     Entry Restrictions

       For sole-active-ingredient end-use products that contain iprodione:

       !      Revise the product labeling to adopt the entry restrictions set forth in this
              section.

       !      Remove any conflicting entry restrictions on the current labeling.

       For multiple-active-ingredient end-use products that contain iprodione:

       !      Compare the entry restrictions set forth in this section to the entry restrictions
              on the current labeling.

       !      Retain the more protective restrictions. (A specific time period in hours or
              days is considered more protective than  "sprays have dried" or "dusts have
              settled.")

              g.    Products Intended Primarily for Occupational Use

                    (1)     WPS Uses

                            (a)    Restricted-entry interval

       A 48-hour restricted-entry  interval  (REI) is required for  iprodione  grape and
ornamental uses. A 24-hour restricted-entry interval (REI) is required for uses within the
scope of the WPS on all other iprodione end-use products.

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                           (b)    Early-entry personal protective equipment (PPE)

              The PPE required for early entry is:
              - coveralls,
              — chemical-resistant gloves,
              - shoes plus socks, and
              — dust/mist respirator.

                           (c)     Placement in labeling

       The REI must be inserted into the standardized REI statement required by Supplement
Three of PR Notice 93-7.  The PPE required for early entry must be inserted into the
standardized early-entry PPE statement required by Supplement Three of PR Notice 93-7.

       Other Labeling Requirements

       Application Restrictions

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

       "If applying this product adjacent to a water body such as a lake, reservoir,
       river, permanent stream, marsh or natural pond, estuary, or commercial fish
      pond, there must be at least a 25-foot vegetative buffer strip between the
       water body and the point of application. Do not apply this product when the
       wind direction is toward aquatic area. "

       "This chemical can contaminate surface water through aerial and ground
       spray applications. Under some conditions, it may also have a high potential
      for runoff into surface water after application.   These include poorly
       draining or wet soils with readily visible  slopes toward adjacent surface
       waters, frequently flooded areas, areas overlaying extremely shallow ground
       water, areas with in-field canals or ditches that drain to surface water, areas
       not separated from adjacent surface waters with vegetated filter strips, and
       areas over-laying  tile drainage systems that drain to surface water."

       "Thispesticide is toxic to invertebrates. 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.  Drift and runoff may be  hazardous to aquatic organisms
       in  neighboring areas. Do not contaminate  water when  disposing  of
       equipment washwater or rinsate."
                                167

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       For Turf Use Only: May apply up to but no more than 24 pounds a.i.
       annually, with a maximum application rate of 8 Ibs. a.i.. Product may be
       applied up to 6 times per year.  There must be at least a 30-day interval
       between applicatons.
       "For Rice Use Only: Do not apply in areas where catfish and crayfish are
       commercially cultivated.'"

       "This product is not registered for use at residential sites. "

       For granular formulation:

       "Thispesticide is toxic to invertebrates. 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.  Runoff may be hazardous  to  aquatic organisms in
       neighboring areas.   Cover, incorporate,  or clean  up spills.   Do not
       contaminate water when disposing of equipment washwater or rinsate."
       Endangered Species:

       For Rice Use Only:   ENDANGERED  SPECIES RESTRICTIONS IN THE
                           STATE OF ARKANSAS

       The use of Iprodione on rice is restricted to protect the endangered fat pocketbook
pearly mussel (Potamilus capax) and its habitat. Use is prohibited in the following areas of
Arkansas.

       Mississippi County: Within the basin that drains directly into the Right Hand Chute
of Little River, south of Big Lake National Wildlife Refuge.

       Poinsett County: Between  Crowley's Ridge and the levee east of the Right Hand
Chute of Little River and the St. Francis Floodway. Use is also prohibited west of Rt. 140
and north of Rt. 63 at the siphon near Marked Tree. Except that the prohibited area does not
include the area bounded by Arkansas Highway 373 on the west, Highway 63 on the east and
Highway 14 on the south.

       Cross, St. Francis and Lee Counties:  Between Crowley's Ridge and the levee east
of the Right Hand Chute of Little River and the  St. Francis Floodway as far south as the
confluence of L'Anguille River (Lee County).

       User Safety Requirements

       1.    Registrants: place the  following statement on the labeling if coveralls are
             required for pesticide handlers on the end-use product label:
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              "Discard clothing or  other absorbent materials that have  been
              drenched or heavily contaminated with this product's concentrate.
              Do not reuse them.'"

       2.      Registrants always place the following statement on the end-use product
              labeling:

              "Follow manufacturer's instructions for cleaning/maintaining PPE.
              If not such instructions for washables, use detergent and hot water.
              Keep and wash PPE separately from  other laundry."

       User Safety Recommendations

       •       "Users should wash hands before eating, drinking, chewing gum,
              using tobacco, or using the toilet."
       •       "Users should remove  clothing 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."

              h.      Spray Drift Labeling

The following language must be placed on each product label that can be applied aerially:

       Avoiding spray drift at the application site is the responsibility of the applicator. The
       interaction of many equipment-and-weather-related factors determine the potential for
       spray drift.  The applicator and the grower are responsible for considering all these
       factors when making decisions.
       The following drift management requirements must be followed to avoid off-target
       drift movement  from  aerial  applications   to  agricultural field crops.   These
       requirements  do not apply to  forestry applications,  public health uses  or  to
       applications using dry formulations.

              1.      The distance of the outer most nozzles on the boom must not exceed
                     3/4 the length of the wingspan or rotor.

              2.     Nozzles must always point backward parallel with the air stream and
                    never be pointed downwards more than 45 degrees.

       Where states have more stringent regulations, they should be observed.

       It is recommended that the applicator should  be familiar with and take into account
       the information covered in the  Aerial Drift Reduction Advisory Information.
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The following aerial drift reduction advisory information must be contained in the
product labeling:

       [This section is advisory in nature and does not supersede the mandatory label
       requirements.]

INFORMATION ON DROPLET SIZE:  The most effective way to reduce drift
potential is to apply large droplets. The best drift management strategy is to apply the
largest droplets that provide sufficient coverage and control. Applying larger droplets
reduces drift potential, but will not prevent drift if applications are made improperly,
or under  unfavorable  environmental  conditions  (see Wind,  Temperature  and
Humidity, and Temperature Inversions).

CONTROLLING DROPLET SIZE:

 !      Volume - Use high flow rate nozzles to apply the highest practical spray
       volume. Nozzles with higher rated flows produce larger droplets.
 !      Pressure - Do not exceed the nozzle manufacturer's recommended pressures.
       For many nozzle types lower pressure produces larger droplets. When higher
       flow rates  are needed, use higher flow rate nozzles instead of increasing
       pressure.

 !      Number of nozzles - Use the  minimum number of nozzles that provide
       uniform coverage.

 !      Nozzle Orientation - Orienting nozzles so that the spray is released parallel to
       the airstream produces larger droplets than other  orientations and is the
       recommended practice. Significant deflection from horizontal will reduce
       droplet size and increase drift potential.

 !      Nozzle Type - Use a nozzle type that is designed for the intended application.
       With most nozzle types,  narrower  spray angles produce larger droplets.
       Consider using low-drift nozzles. Solid stream nozzles oriented straight back
       produce the largest droplets and the lowest drift.

 !      Maintenance of Nozzles - periodic inspection and subsequent replacement of
       nozzles to  ensure proper chemical application is recommended.

BOOM LENGTH: For some use patterns, reducing the effective boom length to
less than 3/4 of the wingspan or rotor length may  further reduce drift without
reducing swath width.

APPLICATION  HEIGHT:   Applications should not be made at a height greater
than 10 feet above the top of the largest plants unless a greater height is required for

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aircraft safety. Making applications at the lowest height that is safe reduces exposure
of droplets to evaporation and wind.

SWATH ADJUSTMENT: When applications are made with a crosswind, the swath
will be displaced downward.  Therefore, on the up and downwind edges of the field,
the  applicator must compensate for this displacement by adjusting the path of the
aircraft upwind.  Swath adjustment distance should increase, with increasing drift
potential (higher wind, smaller drops, etc.)

WIND: Drift potential is lowest between wind speeds of 2-10 mph. However, many
factors,  including droplet size and equipment type determine drift potential at any
given speed.  Application should  be avoided below 2 mph due to variable wind
direction and high inversion potential. NOTE:  Local terrain can influence wind
patterns. Every applicator should be  familiar with local wind patterns and how they
affect spray drift.

TEMPERATURE AND HUMIDITY:  When making applications in low relative
humidity, set up equipment to produce larger droplets to compensate for evaporation.
Droplet evaporation is most severe when conditions are both hot and dry.
TEMPERATURE INVERSIONS:  Applications should not occur during  a
temperature inversion because drift potential is high.  Temperature inversions restrict
vertical air mixing, which causes small suspended droplets to remain in a concentrated
cloud. This cloud can move in unpredictable directions due to the light variable winds
common during inversions.  Temperature inversions are characterized by increasing
temperatures with altitude and are  common on nights with limited cloud cover and
light to no wind.  They begin to form as the sun sets and often  continue into the
morning.  Their presence can be indicated by ground fog; however, if fog is not
present, inversions  can also be identified by the movement of smoke from a ground
source or  an aircraft smoke generator.  Smoke that layers and moves laterally  in a
concentrated cloud (under low wind conditions) indicates an inversion, while smoke
that moves upward and rapidly dissipates indicates good vertical air mixing.

SENSITIVE AREAS: The pesticide should only be applied when the potential for
drift to adjacent sensitive areas (e.g. residential areas, bodies of water, known habitat
for threatened or endangered species, non-target crops) is minimal (e.g. when wind
is blowing away from the sensitive areas).
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Table 62. Required Labeling Changes
Description
Required Labeling
Placement on Label
Manufacturing use
One of these statements may
be added to a label to allow
reformulation of the product
for a specific use or all
additional uses supported by a
formulator or user group.
Environmental Hazards
Statement
"Only for formulation into a/an [fill in blank with insecticide, herbicide, or the applicable term which describes the
type of pesticide use(s) for the following use(s) [fill blank only with those uses that are being supported by the MP
registrant..]"
"This product may be used to formulate products for specific use(s) not listed on the MP label if the formulator,
user group, or grower has complied with U.S. EPA submission requirements regarding support of such use(s)."
"This product may be used to formulate product for any additional use(s) not listed on the MP label if the
formulator, user group, or grower has complied with the U.S. EPA submission requirements regarding support of
such use(s)."
"This product is not registered for use at residential sites. "
"This pesticide is toxic to invertebrates. Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollutant
Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to
discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local
sewage treatment authority. For guidance contact your State Water Board or Regional Office of the EPA."
Directions for Use
Products Intended Primarily for Occupational Use (WPS and non-WPS)
Worker Protection
Requirements for Products
Subject to WPS
Engineering Control
Requirements
General Personal Protective
Equipment (PPE)
Requirements
PPE requirements for liquid
formulations
Any product whose labeling reasonably permits use in the production of an agricultural plant on any farm, forest,
nursery, or greenhouse must comply with the labeling requirements of PR Notice 93-7, "Labeling Revisions
Required by the Worker Protection Standard (WPS), and PR Notice 93-1 1, "Supplemental Guidance for PR Notice
93-7, which reflect the requirements of EPA' s labeling regulations for worker protection statements (40 CFR part
156, subpart K). These labeling revisions are necessary to implement the Worker Protection Standard for
Agricultural Pesticides (40 CFR part 170) and must be completed in accordance with, and within the deadlines
specified in, PR Notices 93-7 and 93-1 1 . Unless otherwise specifically directed in this RED, all statements required
by PR Notices 93-7 and 93-1 1 are to be on the product label exactly as instructed in those notices.
All wettable powder applications that contain directions that would allow aerial or chemigation application must be
formulated in water-soluble packaging the outside of which contains a pictogram depicting that users should not cut,
ripped, or torn.
Default PPE is established on the basis of acute toxicity category of the end-use products in accordance with PR
Notice 93-7. The PPE that would be established on the basis of the acute toxicity category of the end-use product
must be compared to the active-ingredient specific personal protective equipment specified above. The more
protective PPE must be placed on the product labeling. For guidance on which PPE is considered more protective,
see PR Notice 93-7.
"Mixers, loaders, others exposed to the concentrate, cleaners/repairers of equipment, and applicators applying as a
seed soak, seed treatment, or dip treatment must wear:
— long-sleeve shirt and long pants,
— chemical-resistant gloves*,
— chemical-resistant apron, and
— chemical-resistant footwear plus socks."
Use Restriction section in
Directions for Use
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals
Precautionary Labeling
Under Hazards to Humans and
Domestic Animals
                                                                   172

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         Description
                                           Required Labeling
       Placement on Label
PPE requirements for liquid
formulations (continued)
"Applicators using handheld equipment must wear:
— coveralls over long-sleeve shirt and long pants,
— chemical-resistant gloves*,
— chemical-resistant footwear plus socks,
— chemical-resistant headgear for overhead exposures, and
— a dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C).

Applicator using aircraft or mechanical ground equipment (groundboom, airblast, etc.), and flaggers for aerial
applications must wear:
— long-sleeve shirt and long pants, and
— shoes plus socks.

Applicators using truck-mounted equipment with a handgun at the end of a hose (i.e.,  for commercial turfgrass or
ornamental applications)  and all other handlers not specified above must wear:
— long-sleeve shirt and long pants,
— chemical-resistant gloves*,
— shoes plus socks."

*For the glove statement, use the  statement established for iprodione through the instructions in Supplement Three
of PR Notice 93-7.
Precautionary Labeling
Under Hazards to Humans and
Domestic Animals
PPE requirements for products
formulated as wettable
powders or dry flowables
"Mixers, loaders, others exposed to the concentrate, cleaners/repairers of equipment, and applicators applying as a
seed soak, seed treatment, or dip treatment must wear:
— coveralls over long-sleeve shirt and long pants,
— chemical-resistant gloves*,
— chemical-resistant footwear plus socks,
— chemical-resistant apron,  and
— a dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C).
Applicators using handheld  equipment must wear:
— coveralls over long-sleeve shirt and long pants,
— chemical-resistant gloves*,
— chemical-resistant footwear plus socks,
— chemical-resistant headgear for overhead exposures, and
— a dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C).

Applicator using aircraft or mechanical ground equipment (groundboom, airblast, etc.), and flaggers for aerial
applications must wear:
— long-sleeve shirt and long pants, and
— shoes plus socks."
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals
PPE requirements for products
formulated as wettable
powders or dry flowables
(continued)
Applicators using truck-mounted equipment with a handgun at the end of a hose (i.e.,  for commercial turfgrass or
ornamental applications)  and all other handlers not specified above must wear:
— long-sleeve shirt and long pants,
— chemical-resistant gloves*,
— shoes plus socks."
         *For the glove statement, use the statement established for iprodione through the instructions in
	Supplement Three of PR Notice 93-7.	
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals Under
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Description
PPE Requirements for
Granular Formulations
User Safety Requirements
User Safety Requirements for
all products that specify
coveralls in the PPE
Engineering Controls
Engineering Controls for
formulations with water-
soluble packaging
User Safety Requirements
Environmental Hazards,
Ground and Surface Water
Statements
Restricted-Entry Interval for
WPS Uses
Required Labeling
"Loaders, applicators, and other handlers must wear:
— long-sleeved shirt and long pants, and
— shoes plus socks.
In addition, applicators using push-type spreaders must wear chemical-resistant gloves*."
*For the glove statement, use the statement established for iprodione through the instructions in
Supplement Three of PR Notice 93-7.
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables, use
detergent and hot water. Keep and wash PPE separately from other laundry."
"Discard clothing or other materials that have been drenched or heavily contaminated with this product's
concentrate. Do not reuse them."
"Engineering Controls"
"When handlers use closed systems, enclosed cabs, or aircraft in a manner that meets the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides (40CFR 170.240(d)(4-6), the handler PPE
requirements may be reduced or modified as specified in the WPS."
The following Engineering Control statements are required in addition to those specified above:
"Water-soluble packets when used correctly qualify as a closed loading system under the WPS. Handlers handling
this product while it is enclosed in intact water-soluble packets are permitted to wear long-sleeved shirt, long pants,
shoes plus socks, chemical-resistant gloves, and chemical-resistant apron, provided the other required PPE is
immediately available in case the bag is opened."
"User Safety Recommendations"
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet."
"Users should remove clothing 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."
"This chemical can contaminate surface water through aerial and ground spray applications. Under some
conditions, it may also have a high potential for runoff into surface water after application. These include poorly
draining or wet soils with readily visible slopes toward adjacent surface waters, frequently flooded areas, areas
overlaying extremely shallow ground water, areas with in-field canals or ditches that drain to surface water, areas
not separated from adjacent surface waters with vegetated filter strips, and areas over-laying tile drainage systems
that drain to surface water."
"This pesticide is toxic to invertebrates. Do not apply directly to water or to areas where surface water is present or
to intertidal areas below the mean high- water mark. Drift and runoff may be hazardous to aquatic organisms in
neighboring areas. Do not contaminate water when disposing of equipment washwater or rinsate."
The restricted-entry interval for grapes and ornamental uses is 48-hours. The restricted-entry interval for all other
WPS uses is 24-hours.
Placement on Label
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals, Following PPE
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals, Following PPE
Precautionary Statements Under
Hazards to Humans and Domestic
Animals, Following Use Safety
Requirements
Precautionary Statements Under
Hazards to Humans and Domestic
Animals, Following Use Safety
Requirements
Precautionary Labeling Under
Hazards to Humans and Domestic
Animals, Following "Engineering
Controls"
Precautionary Statements
Environmental Hazards
Directions for Use
Agricultural Use Requirements Box
174

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Description
Early-Entry PPE for WPS Uses
Entry restrictions for non-WPS
uses that are applied as sprays
Entry restrictions for non-WPS
uses that are applied as
granulars.
General Application
Restrictions
General Application
Restrictions
General Application
Restrictions
General Application
Restrictions
Required Labeling
The PPE required for early entry is:
—coveralls,
—chemical-resistant gloves*,
—shoes plus socks,
*For the glove statement, use the statement established for iprodione through the instructions in
Supplement Three of PR Notice 93-7.
"Do not enter or allow others to enter the treated area until sprays have dried."
"Do not enter or allow others to enter the treated area until dusts have settled."
"Use of this product at residential sites is prohibited."
"Do not apply this product in a way that will contact workers or other persons, either directly or indirectly or
through drift. Only protected handlers may be in the area during application."
"Except for use on golf courses, if applying this product adjacent to a water body such as a lake, reservoir, river,
permanent stream, marsh or natural pond, estuary, or commercial fish pond, there must be at least a 25-foot
vegetative buffer strip between the water body and the point of application."
For golf courses only, do not apply to turf cut higher than 1 " on golf holes where water bodies are present."
"Do not apply this product when the wind direction is toward aquatic area."
"For Rice Use Only: Do not apply in areas where catfish and crayfish are commercially cultivated."
For granular formulation:
"Do not apply this product using "belly grinder" or other handheld application equipment."
"This pesticide is toxic to invertebrates. Do not apply directly to water or to areas where surface water is present or
Placement on Label
Directions for Use
Agricultural Use Requirements Box
as specified by Supplement Three of
PR Notice 93-7.
If no WPS uses are on the label —
Place the Non WPS entry
restrictions in the Directions for
Use, under the heading "Entry
Restrictions."
If WPS uses are also on label —
Follow the instructions in PR Notice
93-7 for establishing a Non-
Agricultural Use Requirements box,
and place the appropriate Non WPS
entry restrictions in that box.
If no WPS uses are on the label —
Place the Non WPS entry
restrictions in the Directions for
Use, under the heading "Entry
Restrictions."
If WPS uses are also on label —
Follow the instructions in PR Notice
93-7 for establishing a Non-
Agricultural Use Requirements box,
and place the appropriate Non WPS
entry restrictions in that box.
General Precautions and
Restrictions section in Directions
for Use
General Precautions and
Restrictions section in Directions
for Use
General Precautions and
Restrictions section in Directions
for Use
General Precautions and
Restrictions section in Directions
for Use
175

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Description

General Application
Restrictions
Application Restrictions for
Products with Directions for
Applications to Turf
Application Restrictions for
Products with Directions for
Applications to Lawn
Application Restrictions for
Products with Directions for
Applications to Golf Courses
Application Restrictions for
Products with Directions for
Applications to Ornamental
Trees and Plants
Application Restrictions for
Products with Directions for
Applications Table Grapes
Pre-Harvest Intervals (PHI) for
products with Directions for
Application on Strawberry
Pre-Harvest Intervals (PHI) for
products with Directions for
Application on Stone fruits
(Apricots, Cherries,
Nectarines, Plums, Peaches)
Required Labeling
to intertidal areas below the mean high- water mark. Runoff may be hazardous to aquatic organisms in neighboring
areas. Cover, incorporate, or clean up spills. Do not contaminate water when disposing of equipment washwater or
rinsate."
Endangered Species:
For Rice Use Only: ENDANGERED SPECIES RESTRICTIONS IN THE STATE OF ARKANSAS
The use of Iprodione on rice is restricted to protect the endangered fat pocketbook pearly mussel (Potamilus capax)
and its habitat. Use is prohibited in the following areas of Arkansas.
Mississippi County: Within the basin that drains directly into the Right Hand Chute of Little River, south of Big
Lake National Wildlife Refuge.
Poinsett County: Between Crowley's Ridge and the levee east of the Right Hand Chute of Little River and the St.
Francis Floodway. Use is also prohibited west of Rt. 140 and north of Rt. 63 at the siphon near Marked Tree.
Except that the prohibited area does not include the area bounded by Arkansas Highway 373 on the west, Highway
63 on the east and Highway 14 on the south.
Cross, St. Francis and Lee Counties: Between Crowley's Ridge and the levee east of the Right Hand Chute of
Little River and the St. Francis Floodway as far south as the confluence of L'Anguille River (Lee County).
Directions for application to turf must be amended to specify a maximum annual application rate of 24 Ibs. ai per
acre with a maximum of 6 applications.
Directions for application to lawn must be amended to specify a maximum annual application rate of 24 Ibs. ai per
acre with a maximum of 6 applications.
Directions for application to golf courses must be amended to specify a maximum annual application rate of 24 Ibs.
ai per acre with a maximum of 6 applications.
Directions for application to ornamental trees and plants must be amended to specify a maximum annual application
rate of 24 Ibs. ai per acre with a maximum of 6 applications.
Directions for application to table grapes must be amended to specify a maximum seasonal application rate one
application per season at early- to mid-bloom.
Directions for application to strawberries must be amended to specify a pre-harvest interval (PHI) of up to but not
after first flower. Suggested language: "This product may not be applied after first flower."
Directions for application to stone fruits (apricots, cherries, nectarines, plums, peaches) must be amended to specify
a pre-harvest interval (PHI) of up to but not after petal fall. Suggested language: "This product may not be applied
after petal fall."
Placement on Label



General Precautions and
Restrictions section in Directions
for Use
Directions For Application
in Directions for Use
Directions For Application
in Directions for Use
Directions For Application
in Directions for Use
Directions For Application
in Directions for Use
Directions For Application
in Directions for Use
Directions For Application
in Directions for Use
Directions For Application
in Directions for Use
section
section
section
section
section
section
section
176

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Description
Spray Drift Label
Requirements for Product with
Aerial Applications
Aerial Drift Reduction
Advisory Information.
(This section is advisory in
nature and does not supersede
the mandatory label
requirements.)
Aerial Drift Reduction
Advisory Information.
(This section is advisory in
nature and does not supersede
the mandatory label
requirements.)
Aerial Drift Reduction
Advisory Information.
(This section is advisory in
nature and does not supersede
the mandatory label
requirements.)
Required Labeling
"Spray Drift Labeling
Avoiding spray drift at the application site is the responsibility of the applicator. The interaction of many
equipment-and- weather-related factors determine the potential for spray drift. The applicator and the grower are
responsible for considering all these factors when making decisions.
The following drift management requirements must be followed to avoid off-target drift movement from aerial
applications to agricultural field crops. These requirements do not apply to forestry applications, public health uses
or to applications using dry formulations.
1 . The distance of the outer most nozzles on the boom must not exceed 3/4 the length of the wingspan or rotor.
2. Nozzles must always point backward parallel with the air stream and never be pointed downwards more than 45
degrees.
Where states have more stringent regulations, they should be observed.
The applicator should be familiar with and take into account the information covered in the Aerial Drift Reduction
Advisory Information.
INFORMATION ON DROPLET SIZE
The most effective way to reduce drift potential is to apply large droplets. The best drift management strategy is to
apply the largest droplets that provide sufficient coverage and control. Applying larger droplets reduces drift
potential, but will not prevent drift if applications are made improperly, or under unfavorable environmental
conditions (see Wind, Temperature and Humidity, and Temperature Inversions below).
CONTROLLING DROPLET SIZE
! Volume - Use high flow rate nozzles to apply the highest practical spray volume. Nozzles with higher rated flows
produce larger droplets.
! Pressure - Do not exceed the nozzle manufacturer's recommended pressures. For many nozzle types lower
pressure produces larger droplets. When higher flow rates are needed, use higher flow rate nozzles instead of
increasing pressure.
! Number of nozzles - Use the minimum number of nozzles that provide uniform coverage.
! Nozzle Orientation - Orienting nozzles so that the spray is released parallel to the airstream produces larger
droplets than other orientations and is the recommended practice. Significant deflection from horizontal will reduce
droplet size and increase drift potential.
! Nozzle Type - Use a nozzle type that is designed for the intended application. With most nozzle types, narrower
spray angles produce larger droplets. Consider using low-drift nozzles. Solid stream nozzles oriented straight back
produce the largest droplets and the lowest drift.
BOOM LENGTH
For some use patterns, reducing the effective boom length to less than 3/4 of the wingspan or rotor length may
further reduce drift without reducing swath width.
Placement on Label
Directions for Use
Directions for Use
Directions for Use
Directions for Use
177

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         Description
                                           Required Labeling
       Placement on Label
Aerial Drift Reduction
Advisory Information.
(This section is advisory in
nature and does not supersede
the mandatory label
requirements.)
APPLICATION HEIGHT

Applications should not be made at a height greater than 10 feet above the top of the largest plants unless a greater
height is required for aircraft safety. Making applications at the lowest height that is safe reduces exposure of
droplets to evaporation and wind.
Directions for Use
Aerial Drift Reduction
Advisory Information.
(This section is advisory in
nature and does not supersede
the mandatory label
requirements.)
SWATH ADJUSTMENT

When applications are made with a crosswind, the swath will be displaced downward. Therefore, on the up and
downwind edges of the field, the applicator must compensate for this displacement by adjusting the path of the
aircraft upwind.  Swath adjustment distance should increase, with increasing drift potential (higher wind, smaller
drops, etc.)
Directions for Use
Aerial Drift Reduction
Advisory Information.
(This section is advisory in
nature and does not supersede
the mandatory label
requirements.)
WIND

Drift potential is lowest between wind speeds of 2-10 mph. However, many factors, including droplet size and
equipment type determine drift potential at any given speed. Application should be avoided below 2 mph due to
variable wind direction and high inversion potential. NOTE:  Local terrain can influence wind patterns. Every
applicator should be familiar with local wind patterns and how they affect spray drift.
Directions for Use
Aerial Drift Reduction
Advisory Information.
(This section is advisory in
nature and does not supersede
the mandatory label
requirements.)
TEMPERATURE AND HUMIDITY

When making applications in low relative humidity, set up equipment to produce larger droplets to compensate for
evaporation. Droplet evaporation is most severe when conditions are both hot and dry.
Directions for Use
Aerial Drift Reduction
Advisory Information.
(This section is advisory in
nature and does not supersede
the mandatory label
requirements.)
TEMPERATURE INVERSIONS

Applications should not occur during a temperature inversion because drift potential is high.  Temperature
inversions restrict vertical air mixing, which causes small suspended droplets to remain in a concentrated cloud.
This cloud can move in unpredictable directions due to the light variable winds common during inversions.
Temperature inversions are characterized by increasing temperatures with altitude and are common on nights with
limited cloud cover and light to no wind.  They begin to form as the sun sets and often continue into the morning.
Their presence can be indicated by ground fog; however, if fog is not present, inversions can also be identified by
the movement of smoke from a ground source or an aircraft smoke generator. Smoke that layers and moves laterally
in a concentrated cloud (under low wind conditions) indicates an inversion, while smoke that moves upward and
rapidly dissipates indicates good vertical air mixing."
Directions for Use
                                                                                  178

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C.     Existing Stocks

       The Agency has determined that registrants may distribute and sell iprodione products
bearing old labels/labeling for  12  months  from the date of the approval of the new
labels/labeling. The new labels/labeling for risk mitigation as outlined in this document, which
Rhone-Poulenc has already submitted,will be approved following the 60-comment period for
this RED (which begins with publication of the Federal Register (FR) Notice of Availabiltiy),
and following the Agency's review of all those comments received.  Based on the comments
received, the Agency may modify or amend risk mitigation, the approved labels/labeling,
and/or the existing stock provision.

        Persons other  than  the registrant may  distribute or  sell  products  with old
labels/labeling until such stocks are exhausted. Registrants and persons other than registrants
remain obligated to meet pre-existing  Agency-imposed label changes  and existing stocks
requirements applicable to  products they sell or distribute. Refer to "Existing Stocks of
Pesticide Products; Statement of Policy"; Federal Register. Volume 56, No. 123, June 26,
1991.
                                    179

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180

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VI.  APPENDICES
       181

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               Appendix A. Table of Use Patterns Subject to Reregistration
Due to the length of Appendix A (over 100 pages), Appendix A is not included in this RED.
Copies of Appendix A are available upon request per the instructions in Appendix E.
                                         182

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                               GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active
ingredients within the case DEBT covered by this Reregi strati on Eligibility Decision Document. It
contains generic data requirements that apply to DEET in all products, including data requirements
for which a "typical formulation" is the test substance.

       The data table is organized in the following format:

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

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

                           A      Terrestrial food
                           B      Terrestrial feed
                           C      Terrestrial non-food
                           D      Aquatic food
                           E      Aquatic non-food outdoor
                           F      Aquatic non-food industrial
                           G      Aquatic non-food residential
                           H      Greenhouse food
                           I      Greenhouse non-food
                           J      Forestry
                           K      Residential
                           L      Indoor food
                           M     Indoor non-food
                           N      Indoor medical
                           O      Indoor residential

       3.  Bibliographic citation (Column 3).  If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record Identification
(MRID) number, but may be a "GS" number if no MRID number has been assigned. Refer to the
Bibliography appendix for a complete citation of the study.
                                           183

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184

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                APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of
                      Iprodione
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
6 1-2 A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5

63-7
63-8
63-9
63-11
63-13
63-14
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point

Density
Solubility
Vapor Pressure
Octanol/Water Partition
Stability
Oxidizing/Reducing Action
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL

ALL
ALL
ALL
ALL
ALL
ALL
41790801
41790801
41790801
41855501
42698201,41855501
42698201,41855501
41855501,41855502
41855501,41855502
41855501,41855502
41570801, 41855501,
41855502
41517601
41230502, 41855502
41230502, 41230503
42533601
41958501
41836402
ECOLOGICAL EFFECTS
71-1A
7 1-2 A
71-2B
7 1-4 A
71-4B
72-1 A
72-1B
72-2B
72-3A
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Bluegill - TEP
Invertebrate Toxicity - TEP
Estuarine/Marine Toxicity - Fish
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
A,B,C,D
41604101
41604102
41604103
99126
86840
162224, 41604104, 41604105
40489203
41642001, 40489206
42892001, 40489205
                        185

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     Data Supporting Guideline Requirements for the Reregistration of
                                   Iprodione
REQUIREMENT
                                         USE PATTERN
              CITATION(S)
72-3B    Estuarine/Marine Toxicity - Mollusk    A,B,C,D
72-3C    Estuarine/Marine Toxicity - Shrimp     A,B,C,D
72-4A    Early Life Stage Fish                 A,B,C,D
72-4B    Life Cycle Invertebrate               A,B,C,D
72-7B    Actual field-aquatic organism          A,B,C,D
122-2    Aquatic Plant Growth                A,B,C,D

123-1A   Seed Germination/Seedling            A,B,C,D
         Emergence
141-1    Honey Bee Acute Contact             A,B,C,D
TOXICOLOGY
81-1     Acute Oral Toxicity - Rat           A,B,C,D,H,I
81-2     Acute Dermal Toxicity - Rabbit/Rat   A,B,C,D,H,I
81 -3     Acute Inhalation Toxicity - Rat      A,B,C,D,H,I
81 -4     Primary Eye Irritation - Rabbit       A,B,C,D,H,I
81 -5     Primary Dermal Irritation - Rabbit    A,B,C,D,H,I
81-6     Dermal Sensitization - Guinea Pig    A,B,C,D,H,I
82-1A    90-Day Feeding - Rodent           A,B,C,D,H,I
82-1B    90-Day Feeding - Non-rodent       A,B,C,D,H,I

82-2     21-Day Dermal-Rabbit/Rat         A,B,C,D,H,I
83-1A    Chronic Feeding Toxicity - Rodent   A,B,C,D,H,I
83-1B    Chronic Feeding Toxicity -          A,B,C,D,H,I
         Non-Rodent
83-2A    Oncogenicity - Rat                 A,B,C,D,H,I

83-2B    Oncogenicity - Mouse              A,B,C,D,H,I
83-3B    Developmental Toxicity - Rabbit     A,B,C,D,H,I

83-4     2-Generation Reproduction - Rat     A,B,C,D,H,I
84-2A    Gene Mutation (Ames Test)         A,B,C,D,H,I
84-2B    Structural Chromosomal Aberration   A,B,C,D,H,I
42892001, 40489202
40489204, 42169301
40550801
40489201, 40832201
41983601
43575601, 42892001,
41604107
43575601, 41604109,
41604107
44262021

41514302,42306301
40567601
42946101
41867301
41867302
40567602, 42524601
42960701
157377, 157378, 144391,
42211101
42023201, 42468401
42637801
41327001, 144391,42211101

70963, 42787001, 42637801,
71997, 128931, 164249
42825001, 42825002
155469, 162984, 44365001,
40514901
162983,41871601
41604106, 148206
148207, 43535001
                                       186

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     Data Supporting Guideline Requirements for the Reregistration of
                                   Iprodione
REQUIREMENT
                                         USE PATTERN
                          CITATION(S)
84-4     Other Genotoxic Effects
85-1     General Metab oli sm

85-2     Dermal Penetration
ENVIRONMENTAL FATE
160-5    Chemical Identity
161-1    Hydrolysis
161-2    Photodegradati on - Water
161-3    Photodegradati on - Soil
162-1    Aerobic Soil Metabolism
162-4    Aerobic Aquatic Metabolism
163-1    Leaching/Adsorption/Desorpti on
164-1    Terrestrial Field Dissipation
165-1    Confined Rotational Crop
165-2    Field Rotational Crop
165-3    Accumulation - Irrigated Crop
165-4    Bioaccumulation in Fish
RESIDUE CHEMISTRY
171 -4 A   Nature of Residue - Plants
171-4B   Nature of Residue - Livestock
171-4C   Residue Analytical Method - Plants
171-4D   Residue Analytical Method - Animal
171-4E   Storage Stability
171-4 J   Magnitude of Residues-
         Meat/Milk/Poultry/Egg
171-4K   Crop Field Trials (almond)
171-4K   Crop Field Trials (beans, dried)
171-4K   Crop Field Trials (beans, succulent)
171-4K   Crop Field Trials (caneberries)
A,B,C,D,H,I
A,B,C,D,H,I
148209, 148208
41346701,42984101,
43484901
A,B,C,D,H,I  4355003
A,B,C,D,H,I
A,B,C,D,H,I
A,B,C,D,H,I
A,B,C,D,H,I
A,B,C,D,H,I
A,B,C,D,H,I
A,B,C,D,H,I
A,B,C,D,H,I
A,B,C,D,H,I
A,B,C,D,H,I
A,B,C,D,H,I
  A,B,C,D
  A,B,D,H
  A,B,D,H
  A,B,D,H
  A,B,D,H
  A,B,D,H
  A,B,D,H

     A
     A
     A
     A
41790801
41885401
41861901,42201301
43362001, 42897101
44590501, 43091002
42503801, 41927601
43349202, 43349201
41877401
43596201
43718201
  162218
43091001

92083074
  130833, 130835
43526801
43958202, 41878001
43702501, 43273401
43958201

  150019
43255701, 43222501
43295101,43245801
43262501
                                       187

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      Data Supporting Guideline Requirements for the Reregistration of
                                      Iprodione
REQUIREMENT                           USE PATTERN                CITATION(S)
171-4K   Crop Field Trials (carrot)                 A          164882
171-4K   Crop Field Trials (grapes)                A       43034101,43034102
171-4K   Crop Field Trials (kiwi fruit)              A       42506601,42132801
171-4K   Crop Field Trials (small fruit and          A       43222502
          Berries)
171-4K   Crop Field Trials (stone fruit group)       A       44576601,44441701
                               GUIDE TO APPENDIX C

1.      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.

2.      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.

3.      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.

4.      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.
                                          188

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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.
                                    189

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                                BIBLIOGRAPHY
MRID
CITATION
00070963     Hastings, S.E.; Kiggins, E.M.; Page, J.G.; et al. (1978) Chronic Toxicologic and
             Carcinogenic Study with RP 26019 in Mice: Report No. SEH 75:133. Final rept.
             (Unpublished study received Jun 1, 1978 under 359-EX-58; submitted by
             Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:097203-A)

00071997     Hastings, S.E.; Kiggins, E.M.; Page, J.G.; et al. (1978) Chronic Toxicologic and
             Carcinogenic Study with RP 26019 in Rats: Report No. SEH 76:57.  24 month
             final rept. (Unpublished study received Jun 1, 1978 under 359-EX-58; submitted
             by RhonePoulenc Chemical Co., Monmouth Junction, N.J.; CDL:097201-B)

00086840     Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report One-generation
             Reproduction  Study-Mallard Duck: Iprodione Technical: Project No. 171-103.
             (Unpublished study received Oct 26, 1981 under 46153-1; prepared by Wildlife
             International, Ltd., and Rhone-Poulenc, Inc., submitted by Precision
             Compounding, Inc., Newark, N.J.; CDL:246150-C)

00099126     Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report: One-generation
             Reproduction  Study—Bobwhite Quail: Iprodione Technical: Project No. 171-102.
             (Unpublished study received Oct 26, 1981 under 46153-1; prepared by Wildlife
             International, Ltd. and Rhone-Poulenc, Inc., submitted by Precision Compounding,
             Inc., Newark, N.J.; CDL:246150-B)

00128931     Brooks, P.; Roe, F. (1983) Two Year Chronic Oral Toxicity Study with Antor
             Technical in Albino Rats: Grading of Histopathological Lesions: FBC Report
             Tox/83/178-12.  (Unpublished study received Jun  14, 1983 under 45639-54;
             prepared by FBC Limited, Eng., submitted by BFC Chemicals, Inc., Wilmington,
             DE; CDL: 250494-A)

00130833     Wilkes, L.; Herrera, R.; Bache, B. (1982) Metabolism of 14C-Iprodione
             (14C-RP26019) in Laying Hens: ADC Project #675. (Unpublished study received
             Sep 15, 1983 under 359-685; prepared by Analytical Development Corp.,
             submitted by Rhone-Poulenc, Inc., Monmouth Junction, NJ; CDL:071950-A)

00130834     Wargo, J.; Heinzelmann, G; Gerecke, D.; et al. (1983) Analysis of Tissues and
             Eggs from Treated Laying Hens Fed Iprodione: ASD No. 83/028. (Unpublished
             study received Jul 15, 1983 under 359-685; submitted by Rhone-Poulenc, Inc.,
             Monmouth Junction, NJ; CDL:071951-A)

00130835     Piznik, M.; Wargo, J. (1983) Identification of Major Unknowns from Goat Tissues
             and Urine through the Metabolism of 14C-Iprodione (RP-26019): ASD No.
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00144391     Broadmeadow, A. (1984) Iprodione: 52-week Toxicity Study in Dietary
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00147226     Rhone-Poulenc, Inc. (1985) Additional Chromatograms ?and Field Data Report
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00148206     Godek, E. (1985) CHO/HGPRT Mammalian Cell Forward Gene Mutation Assay:
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00148207     SanSebastian, J. (1985) CHO Metaphase Analysis in vitro Chromosome
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00148208     Worthy, B. (1985) DNA Damage in Bacillus subtilis with Iprodione Technical:
             Final Report: Project No. 2214. Unpublished study prepared by Borriston Labs,
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00148209     SanSebastian, J. (1985) In vitro Sister Chromatid Exchange in Chinese Hamster
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00155469     Rodwell, D.  (1985) A Teratology Study in Rabbits with Iprodine:  Final Report:
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00156397     Guyton, C. (1986) Residue Data for Potato Tubers, Culls and Processed Fractions
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00157377     Centre de Recherche et d'Elevage des Oncins (1976) 3 Month Study of Toxicity of
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00157378     Ganter; Girard, M. (1977) Product 26 019 R.P.: Histological Examination of
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                                         191

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00162218    Gemma, A.; Heinzelmann, G.; Wargo, J. (1986) Iprodione Aquatic Field
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00162224    Swigert, J.; Franklin, B.; Seidel, A.; et al. (1986) Acute Flowthrough Toxicity of
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00162983    Tesh, J.; McAnulty, P.; Deans,  C. (1986) Iprodione (Technical Grade): Effects of
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00162984    Tesh, J.; McAnulty, P.; Deans,  C.; et al. (1986) Iprodione (Technical Grade):
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00164249    Microscopy for Biological Research, Ltd. (1978) Chronic Toxicologic and
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00164882    Gillings, O. (1986) Residue Data for Carrots Treated with Rovral: (Field Programs
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40489201    Surprenant, D.  (1988) The Chronic Toxicity of Iprodione Technical to Daphnia
             magna under Flow-through Conditions: Report #87-122573: Study
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40489202    Surprenant, D.  (1987) Acute Toxicity of Iprodione Technical to Eastern Oysters
             (Crassostrea virginica) under Flow-through Conditions: SLS Report #87-12-2584:
             SLS Study #10566.1087.6115.504. Unpublished study prepared by Springborn
             Life Sciences, Inc. 45 p.

40489203    Surprenant, D.  (1987) Acute Toxicity of Rovral 50 WP to Bluegill (Lepomis
             macrochirus) under Flow-through Conditions: SLS Report #87-12-2578: SLS
             Study #10566.1087.6111.105.  Unpublished study prepared by Springborn Life
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                                         192

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40489204    Surprenant, D. (1987) Acute Toxicity of Iprodione Technical to Mysid Shrimp
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             SLS Study #10566.1087.6113.515.  Unpublished study prepared by Springborn
             Life Sciences, Inc. 45 p.

40489205    Surprenant, D. (1988) Acute Toxicity of Iprodione Technical to Sheepshead
             Minnow (Cyprinodon variegatus) under Flow-through Conditions: SLS Report
             #87-11-2583:  SLS Study #10566.1087.6114. 505.  Unpublished study prepared by
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40489206    Surprenant, D. (1988) Acute Toxicity of Rovral 50 WP to Daphnids (Daphnia
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40514901    Tesh, J.; McAnulty, P.; Lambert, E.; et al. (1987) Iprodione (Technical Grade):
             Teratology Study in the Rat: Supplementary Litter Data: Laboratory Identification
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40550801    Surprenant, D. (1988) The Toxicity of Iprodione Technical to Fathead Minnow
             (Pimephales promelas) Embryos and Larvae: Rept. No. 88-2-2639. Unpublished
             study prepared by Springborn Life Sciences, Inc. 59 p.

40567601    Plutnick, R. (1987) Iprodione (Technical)-Acute Dermal Limit Test in the Rabbit:
             Laboratory Project ID 209806/MRD-87-098. Unpublished study prepared by
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40567602    Trimmer, G. (1987) Iprodione (Technical)--Dermal Sensitization Test in the
             Guinea Pig (Buehler Method): Laboratory Project ID 209821/MRD-87-098.
             Unpublished study prepared by Exxon Biomedical Sciences, Inc. 45 p.

40832201    Surprenant, D. (1988) Chronic Toxicity of Iprodione Technical to Mysid Shrimp
             (Mysidopsis bahia): Supplement Study: Report #88-62761: Study
             #10566.0388.6117.530. Unpublished study prepared by Springborn Life Sciences,
             Inc.  65 p.

41327001    Blacker, A.; Broadmeadow, A. (1989) Iprodione: 52 Week Toxicity Study in
             Dietary Administration to Beagle Dogs-Addendum to Study Asssigned MRID No.
             00144391: Lab Project Number: NS 12/14. Unpublished study prepared by Life
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                                         193

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41346701     Hallifax, D. (1989) Iprodione: Absorption, Distribution, Metabolism and Excretion
             Study in the Rat: Lab Project Number: 89/RPM005/ 1013. Unpublished study
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41570801     Chabassol, Y.; Chabert, M. (1990) Iprodine Melting Point: Lab Project Number:
             90-01. Unpublished study prepared by Rhone-Poulenc Secteur Agro. 23 p.

41604101     Culotta, I; Hoxter, K.; Smith, G. et al. (1990) Iprodione: An Acute Oral Toxicity
             Study with the Northern Bobwhite: Lab Project Number: 171-120.  Unpublished
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41604102     Driscoll, C.; Foster, J.; Hoxter, K. et al. (1990) Iprodione Technical: A Dietary
             LC50 Study with the Northern Bobwhite: Lab Project Number: 171-118.
             Unpublished study prepared by Wildlife International Ltd. 73 p.

41604103     Driscoll, C.; Foster, J.; Hoxter, K. et al. (1990) Iprodione Technical: A Dietary
             LC50 Study with the Mallard: Lab Project Number: 171-119. Unpublished study
             prepared by Wildlife International Ltd. 73 p.

41604104     Sousa, J. (1990) Iprodione Technical: Acute Toxicity to Bluegill sunfish (Lepomis
             macrochirus) under Flow-Through Conditions: Lab Project Number: 90-5-3329:
             10566.1089.6140.105.  Unpublished study prepared by Springborn Laboratories,
             Inc.  55  p.

41604105     Sousa, J. (1990) Iprodione Technical: Acute Toxicity to Rainbow Trout
             (Oncorhynchus mykiss) under Flow-through Conditions: Lab Project Number:
             90-5-3331: 10566.1089.6139.108. Unpublished study prepared by Springborn
             Laboratories, Inc.  54 p.

41604106     Lawlor, T.; Valentine, D. (1990) Mutagenicity  Test on Iprodione (Technical) in
             the Salmonella/Mammalian-Microsome Assay:  Final Report: Lab Project Number:
             HLA 11092-0-401R. Unpublished study prepared by Hazleton Laboratories
             America, Inc.  32 p.

41604107     Giddings, J. (1990) Iprodione Technical: Toxicity to the Freshwater Green Alga
             Selenastrum Capricornutum: Final Report: Lab Project Number: 90-06-3346:
             10566-1089-6141-430.  Unpublished study prepared by Springborn Laboratories,
             Inc.  50  p.
                                         194

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41604108    Giddings, J. (1990) Iprodione Technical: Toxicity to the Duckweed Lemna gibba
             G3: Lab Project Number: 90-06-3351: 10566.1089.614. 410. Unpublished study
             prepared by Springborn Laboraotries, Inc.  40 p.

41604109    Giddings, J. (1990) Iprodione Technical: Toxicity to the Marine Diatom
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41642001    McNamara, P. (1990) Iprodione Technical—Acute Toxicity to Daphnids (Daphnia
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41790801    Besnoin, J. (1991) Iprodione RP 26019: Data on Product Indentity and
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41836402    Chabassol, Y.; Chabert, M. (1991) Iprodione Technical Grade: Oxidizing or
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             Unpublished study prepared by Rhone-Poulenc Secteur Agro.  21 p.

41855501    Chabassol, Y.; Chabert, M.; Venet, C. (1991) Iprodione: Technical Grade Analysis
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41855502    Chabassol, Y.; Gomez, J. (1991) Iprodione Technical Grade: Solubility at 20
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41861901    Adrian, P.; Robles, J. (1991) Carbon 14-Iprodione: Aqueous Photolysis: Lab
             Project Number: 90/22: AG/CBLD/AN/9115524. Unpublished study prepared by
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41867301    Bonnette, K. (1991) Primary Eye Irritation  Study in Rabbits with Iprodione: Final
             Report: Lab Project Number: 3147/109.  Unpublished study prepared by
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41867302    Bonnette, K. (1991) Primary Skin Irritation Study in Rabbits with Iprodione: Final
             Report: Lab Project Number: 3147.108.  Unpublished study prepared by
             Springborn Laboratories, Inc.  23  p.

                                         195

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41871601     Kenwood, S. (1991) Two-generation Reproduction Study with Iprodione
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41877401     Norris, F. (1991) A Terrestrial Field Soil Dissipation Study with Iprodione: Lab
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             275 p.

41878001     Ver Hey, M. (1991) Analysis of Vinciozolin and Iprodione Residues in Animal
             Matrices Using Food and Drug Administration Pesticide Analytical Manual,
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41885401     Das, Y. (1990) Hydrolysis of [Phenyl(U)-[carbon 14]]Iprodione in Aqueous
             Solutions Buffered  at pH 5, 7 and 9: Lab Project Number: 89100. Unpublished
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41927601     Spare, W. (1991) Aerobic Aquatic Metabolism of Iprodione: Lab Project Number:
             1514. Unpublished study prepared by Agrisearch Inc.  147 p.

41958501     Sanders, J. (1991) Iprodione Technical: Determination of Stability: Lab Project
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41983601     Biever, R. (1991) Rovral  (Iprodione): Aquatic Residue Monitoring Study on Rice:
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42023201     Siglin, J. (1991) 21-Day Dermal Toxicity Study in Rabbits with Iprodione
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42132801     Chow, W.; Rives, D. (1991) Residues of Iprodione in/on Kiwi Fruit Resulting
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42169301     Surprenant, D. (1991) Response to EPA FIFRA 88 Phase 4 Data Call-in on
             Iprodione (...)~Acute Toxicity to Mysid Shrimp: Lab Project Number:
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                                         196

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42169302     Blacker, A. (1991) Response to EPA FIFRA 88 Phase 4 Data Call-in on Iprodione
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42201301     Adrian, P.; Robles, J. (1992) Carbon 14-Iprodione Aqueous Photolysis Addendum
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42306301     Cummins, H. (1989) Iprodione: Acute Oral Toxicity Study in the Rat: Lab Project
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42468401     Blacker, A. (1992) 21-Day Dermal Toxicity Study in Rabbits with Iprodione
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             Spare, W. (1992) Aerobic Aquaticc Metabolism of Iprodione: Supplemental
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             Hunt, T. (1992) Additional Data to Support MRID 42132801: Residues of
             Iprodione in/on Kiwi Fruit Resulting from Foliar Applications of Rovral FLO
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42524601     Blacker, A.; Bars, R. (1992) Additional Data to Support MRID No. 40567602:
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42533601     South, P. (1992) Determination of the N-Octanol/Water Partition Coefficient of
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42637801     Chambers, P.; Crook, D.; Gibson,  W.; et  al. (1992) Iprodione: Potential
             Tumorigenic and Toxic Effects in  Prolonged Dietary Administration to Rats: Lab
             Project Number: RNP 346/920808. Unpublished study prepared by
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42503801
42506601
                                         197

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42698201     Gomez, F. (1992) Iprodione Technical Grade Analysis and Certification of Product
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             Unpublished study prepared by Rhone-Poulenc Agrochimie.  43 p.

42787001     Larochelle, D. (1993) Letter Sent to B. Chambliss and K. Davis dated May 12,
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42825001     Bars, R.; Blacker, A.; Urtizberea, M. (1993) Discussion Document—[prodione:
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42825002     Chambers, P.; Crook, D.;  Gibson, W.; et al. (1993) Iprodione: Potential
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42892001     Surprenant, D.; Giddings, J. (1993) Response to EPAs Data Evaluation Report of
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42897101     John, A.; French, N.; Lowden, P. (1993) Fungicides: (Carbon 14) Iprodione: Soil
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42946101     Nachreiner, D. (1993) Iprodione: Acute Dust Inhalation Toxicity Study in Rats:
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42960701     Fryer, S.; Duckworth, J.; Gibson, W.; et al. (1993) Iprodione Sub-Acute Toxicity
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42984101     D'Souza, G. (1993) (Carbon 14)-Iprodione: Absorption, Metabolism and
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             222 p.

43034101     Hovis, A. (1992) ROVRAL: Grapes: Chemigation: Magnitude  of Residue: Final
             Report: Lab Project Number: USA91R22. Unpublished study prepared by

                                         198

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             Rhone-Poulenc Ag Co.; Lance W. Beem; Plant Sciences Inc. and Western Ag
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43034102     Gillings, O. (1989) Rovral: Determination of RP-26019 and its Metabolites in/on
             Dry, Succulent, Oily and Non-Oily Crops by Gas Liquid Chromatography and
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43091001     Pottinger, T. (1994) Final Report: A Fish Bioaccumulation and Depuration Study
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43091002     Waring, A. (1993) (carbon 14)~Iprodione: Aerobic Soil Metabolism: Final
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43222501     Murayama, S. (1994) Rovral/Dry Beans/Magnitude of Residue/Raw Agricultural
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43222502     Hovis, A. (1994) Ground Application of ROVRAL WP Fungicide to Blueberries
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43255701     Murayama, S. (1994) Rovral/Dry Beans/Magnitude of Residue/Raw Agricultural
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43262501     Hovis, A. (1994) Ground Application of Rovral WP Fungicide to Raspberries to
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43273401     Plaisance, R.  (1994) Storage Stability of Iprodione (RP-26019), its Isomer (RP
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                                        199

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43349201     Newby, S.; Ayliffe, J.; Jones, M. (1994) Iprodione: Aged Leaching Study in Four
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43349202     Burr, C.; Newby, S. (1994) Iprodione: Adsorption/Desorption to and from Four
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43362001     John, A.;  French, N.; Lowden, P. (1993) Fungicides: (carbon 14) Iprodione: Soil
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43484901     Fisher, P. (1994) (Carbon 14)-Iprodione: Absorption, Metabolism and Excretion in
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43526801     Thiem, D. (1995) Independent Laboratory Method Validation for "General
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43535001     Proudlock, R.; Elmore, E. (1994) Iprodione: Mouse Micronucleus Test: Final
             Report: Lab Project Number: RNP 442/941483: RPA/IPR/94031. Unpublished
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43535002     Fail, P.; Anderson, S.; Pearce, S. (1994) Toxicity Testing of a Fungicide,
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             Number: 65C-5703: 474: 486. Unpublished study prepared by Research Triangle
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43535003     Cheng, T. (1994) Dermal Absorption of (carbon 14)-Iprodione  (ROVRAL 4F) in
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43575601     Suprenant, D. (1995) Supplement Data for: Iprodione Technical: Toxicity to the
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43596201     Jordan, R.; Wyatt, D. (1995) Confined Accumulation Study on Rotational Crops
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43702501     Gillings, O. (1995) A Study in Support of the Report: "Storage Stability of
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43718201     Gemma, A.; Gillings, O. (1988) Residues of Iprodione and Its Metabolites in/on
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43830601     Benahmed, M. (1995) Effects of Iprodione and Its Metabolites on Testosterone
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             INSURM/U407/95001. Unpublished study prepared by Institut National De La
             Sante Et De La Recherche Medicale.  45 p.

43958201     Norris, F. (1996) Iprodione: Magnitude of Residues in Meat and Eggs of Laying
             Hens: Lab  Project Number: 44948: US94R059R: ML94-0497-RHP.  Unpublished
             study prepared by PTRL East, Inc.; Morse Labs, Inc. and Horizon Labs, Inc. 749
             P-

43958202     Wiens, A. (1995) Independent Laboratory Validation of the Method for
             Quantitation of Iprodione and Its Non-Hydroxylated Metabolites in Chicken Liver:
             Final Report: Lab Project Number: 1488: ADC 1488-1: METH-71.  Unpublished
             study prepared by Analytical Development Corp. 31 p.

44171901     Benahmed, M. (1996) Effects of Iprodione and Its Metabolites RP 36112 and RP
             36115 on Testosterone Secretion in Cultured Leydig Cells: Sites of Action: Final
             Report: Lab Project Number: INSERM/U 407/96001: 407/96001.  Unpublished
             study prepared by INSERM.  53 p.

44171902     Bigot, D. (1996) Iprodione: Exploratory 14-Day Toxicity Study in the Mouse by
             Dietary Administration: Lab Project Number: SA 95131.  Unpublished study
             prepared by Rhone-Poulenc Agrochimie. 485 p.

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                                BIBLIOGRAPHY
MRID
CITATION
44171903     Fail, P.; Anderson, S.; Pearce, S. (1996) Toxicity Testing of a Fungicide,
             Iprodione: Endocrine Toxicology Studies of Testes from Adult Male CD Sprague
             Dawley Rats Exposed to Iprodione in vitro (and in vivo): Final Report: Lab
             Project Number: 65C-6169: RT95-IPDB: RTI-532. Unpublished study prepared
             by Research Triangle Institute.  151 p.

44171904     Fail, P.; Anderson, S.; Pearce, S. (1996) Toxicity Testing of a Fungicide,
             Iprodione: Endocrine Toxicology Studies of Testes from Adult Male CD Sprague
             Dawley Rats Exposed to Iprodione in vivo: Final Report: Lab Project Number:
             65C-6169: RT95-IPDA: RTI-527. Unpublished study prepared by Research
             Triangle Institute.  137 p.

44203401     Eldridge, S. (1996) Cell Proliferation in Rat Testes: Supplement to MRID
             #43535002, Toxicity Testing of a Fungicide, Iprodione, in Adult Male CD
             Sprague Dawley Rats: Lab Project Number: PAI SN 94-4247. Unpublished study
             prepared by Pathology Associates International. 8 p.

44365001     Repetto-Larsay, M. (1997) Toxicology Study in Pregnant Rat by Gavage to
             Examine Sex Differentiation: Iprodione: Lab Project Number: SA 96448:
             SA96448. Unpublished study prepared by Rhone-Poulenc Agrochimie. 204 p.

44441701     Macy, L. (1997) Iprodione: Magnitude of Iprodione Residues in/on Peach Fruit,
             Peel, and Pulp Following Foliar Applications of ROVRAL 4F: Final Study Report:
             Lab Project Number: 45451: 97R12515: 12515-01. Unpublished study prepared
             by Chemtec Research and Development and Plant  Sciences, Inc. 320 p. (OPPTS
             860.1520}

44576601     Macy, L. (1998) Iprodione: Effects of Processing on Iprodione Residues from
             Three Foliar Applications of Rovral 4F to Peach Trees: Final Study Report: Lab
             Project Number: 97R13413: 13413-01:  13413-03.  Unpublished study prepared by
             ACDS Research, Inc. and CMS, Inc. 298 p. {860.1520}

44590501     Waring, A. (1993) (carbon 14)-Iprodione: Soil  Degradation: Final Report: Lab
             Project Number: 68/139-1015. Unpublished study prepared by Hazleton UK. 73
             P-

92083074     Buys, M.; Gerecke, D.; Gemma, A.;  et al. (1990) Rhone-Poulenc Ag Company
             Phase 3 Reformat of MRID 00086082.  Metabolism of Carbon 14Iprodione in
             Peaches: RPI Project ASD #81/001.  Prepared  by RHONE-POULENC AG CO.
             51 p.
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                       BIBLIOGRAPHY




MRID                  CITATION
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                   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

          1                             WASHINGTON, D.C. 20460


                                                                             OFFICE OF
                                                                       PREVENTION, PESTICIDES
                                                                        AND TOXIC SUBSTANCES
GENERIC DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active ingredient(s)
identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to submit certain
data as noted herein to the U. S. Environmental Protection Agency (EPA, the Agency). These data are
necessary to maintain the continued registration of your product(s) containing this active ingredient(s).
Within 90 days after you receive this Notice you must respond as set forth in Section III below.  Your
response must state:

1.      how you will  comply with the requirements set forth in this Notice and its Attachments 1
       through 4; or,

2.      why you believe you are exempt from the requirements listed in this Notice and in Attachment
       3, Requirements Status and Registrant's Response Form, (see section III-B); or,

3.      why you believe EPA should not require your submission of data in the manner specified by
       this Notice (see section III-D).

       If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with
its requirements  or should be exempt or excused  from doing so, then the  registration of your
product(s) subject to this Notice will be subject to suspension. We have provided a list of all of your
products subject to  this Notice in Attachment 2, Data Call-In Response Form, as well as a list of all
registrants who were sent this Notice (Attachment 4).

       The authority  for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7U.S.C. section 136a(c)(2)(B). Collection of this information
is authorized under  the Paperwork Reduction Act by OMB Approval  No. 2070-0107 and 2070-0057
(expiration date 3-31-99).
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     This Notice is divided into six sections and five Attachments.  The Notice itself contains
information and instructions applicable to all Data Call-In Notices.  The Attachments contain specific
chemical information and instructions. The six sections of the Notice are:

       Section I      -    Why You Are Receiving This Notice
       Section II     -    Data Required By This Notice
       Section III    -    Compliance With Requirements Of This Notice
       Section IV    -    Consequences Of Failure To Comply With This Notice
       Section V     -    Registrants'Obligation To Report Possible Unreasonable Adverse
                         Effects
       Section VI    -    Inquiries And Responses To This Notice

   The Attachments to this Notice are:

       Attachment 1  -    Data Call-In Chemical Status Sheet
       Attachment 2  -    Data Call-In Response Form (Insert A)
       Attachment 3  -    Requirements Status And Registrant's Response Form (Insert B)
       Attachment 4  -    List Of All Registrants Sent This Data Call-In Notice
SECTION I.  WHY YOU ARE RECEIVING THIS NOTICE

       The Agency has reviewed existing data for this active ingredient(s) and reevaluated the data
needed to support continued registration of the subject active ingredient(s).  This reevaluation
identified additional data necessary to assess the health and safety of the continued use of products
containing this active ingredient(s).  You have been sent this Notice because you have product(s)
containing the subject active ingredient(s).

SECTION II.  DATA REQUIRED BY THIS NOTICE

       A.    DATA REQUIRED

             The data required by this Notice are specified in the Requirements Status and
       Registrant's Response Form (Insert B). Depending on the results of the studies required in this
       Notice, additional testing may be required.

       B.    SCHEDULE FOR SUBMISSION OF DATA

             You are required to submit the data or otherwise satisfy the data requirements specified
       in Attachment 3, Requirements Status and Registrant's Response Form (Insert B), within the
       time frames provided.

       C.    TESTING PROTOCOL

             All studies required under this Notice must be conducted in accordance with test
       standards outlined  in the  Pesticide Assessment Guidelines for those  studies for which
       guidelines have been established.

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             These EPA Guidelines are available from the National Technical Information Service
       (NTIS), Attn: Order Desk, 5285 PortRoyal Road, Springfield, Va 22161 (tel: 703-487-4650).

             Protocols approved by the Organization for Economic Cooperation and Development
       (OECD) are also  acceptable if the OECD-recommended test standards conform to those
       specified in the Pesticide Data Requirements regulation (40 CFR ง 158.70). When using the
       OECD protocols,  they should be modified as appropriate so that the data generated by the
       study will satisfy the requirements of 40 CFR ง 158. Normally, the Agency will not extend
       deadlines for complying with data requirements when the  studies were not conducted in
       accordance with acceptable standards. The OECD protocols are available from 2001 L Street,
       N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone number
       202-785-0350).

             All new studies and proposed protocols submitted in response to this Data Call-In
       Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].

       D.     REGISTRANTS RECEIVING PREVIOUS SECTION 3 (cฅ2ฅB) NOTICES ISSUED
             BY THE AGENCY

             Unless otherwise noted herein, this Data Call-In does not in any way supersede or
       change the requirements of any previous Data Call-In(sX or any other agreements entered into
       with  the Agency pertaining to such prior Notice.   Registrants must comply  with the
       requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their affected
       products.

SECTION HI. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

       A.     SCHEDULE FOR RESPONDING TO THE AGENCY

              The appropriate responses initially required by this Notice must be submitted to the
       Agency within 90  days after your receipt of this Notice. Failure to adequately respond to this
       Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent to Suspend
       (NOIS) affecting your products. This and other bases for issuance of NOIS due to failure to
       comply with this Notice are presented in Section IV-A and IV-B.

             B.     OPTIONS FOR RESPONDING TO THE AGENCY

             The options  for responding to this Notice are: 1) voluntary cancellation, 2) delete
       use(s), (3) claim generic data exemption, (4) agree to satisfy the data requirements imposed
       by this Notice or (5) request a data waiver(s).

             A discussion of how to respond if you chose the Voluntary Cancellation option, the
       Delete Use(s) option or the Generic Data Exemption option is presented below. A discussion

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of the various options available for satisfying the data requirements of this Notice is contained
in Section III-C.  A discussion of options relating to requests for data waivers is contained in
Section III-D.

       There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the Data-
Call-in Response Form (Insert A) and the Requirements Status and Registrant's Response
Form (Insert B). The Data Call-In Response Form (Insert A) must be submitted as partof every
response to this Notice. Please note that the company's authorized representative is required
to sign the first page of the Data Call-In Response Form (Insert A) and Requirements Status
and Registrant's Response Form (InsertB) and initial any subsequent pages. The forms contain
separate detailed instructions on the response options.  Do not alter the printed material. If
you have questions or need assistance in preparing your response, call or write the contact
person identified in Attachment 1.

       1.      Voluntary Cancellation - You may avoid the requirements of this Notice by
       requesting voluntary cancellation of your product(s) containing the active ingredient(s)
       that is the subject of this Notice. If you wish to voluntarily cancel your product, you
       must submit a completed Data Call-In Response Form  (Insert A), indicating your
       election of this option. Voluntary  cancellation is item number 5 on the Data Call-In
       Response Form (Insert A). If you choose this option, this is the only form that you are
       required to complete.

              If you choose to voluntarily cancel your product, further sale and distribution
       of your product after the effective date of cancellation must be in accordance with the
       Existing Stocks provisions of this Notice  which are contained in Section IV-C.

       2.      Use Deletion - You may avoid the requirements of this Notice by eliminating
       the uses of your product to which the requirements apply. If you wish to amend your
       registration to delete uses, you must submit the Requirements Status and Registrant's
       Response Form (Insert B), a completed application for amendment, a copy of your
       proposed amended labeling, and all other information required for  processing the
       application.  Use deletion is option number 7 on the Requirements Status and
       Registrant's Response Form (Insert B).  You must also complete a Data Call-In
       Response Form (Insert A) by  signing the certification, item number 8. Application
       forms for amending registrations may be obtained from the Registration Support and
       Emergency Response Branch, Registration Division, (703) 308-8358.

              If you choose to delete the use(s) subject to this Notice or uses  subject to
       specific data requirements, further sale, distribution, or use of your product after one
       year from the due date of your 90 day response, must bear an amended label.

       3.      Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an applicant for
       registration of a product is exempt from the requirement to submit or cite generic data

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concerning an active ingredient(s) if the active ingredient(s) in the product is derived
exclusively from purchased,  registered  pesticide products  containing the active
ingredient(s). EPA has concluded, as an exercise of its discretion, that it normally will
not suspend the registration of a product which would qualify and continue to qualify
for the generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify, all of the
following requirements must be met:

       a.   The active ingredient(s) in your registered product must be present solely
       because of incorporation of another registered product which contains the
       subject active ingredient(s) and is purchased from a source not connected with
       you; and,

       b.   every registrant who is  the ultimate source of the active ingredient(s) in
       your product subject to this DCI must be in compliance with the requirements
       of this Notice and must remain in compliance; and

       c.   you must have provided to EPA an accurate and current "Confidential
       Statement of Formula" for each of your products to which this Notice applies.

       To apply for the Generic Data Exemption you must submit a completed Data
Call-In Response Form (Insert A), and all supporting documentation.  The Generic
Data Exemption is item number 6a on the Data Call-In Response Form (Insert A). If
you claim a generic data exemption you are not required to complete the Requirements
Status and Registrant's Response Form (Insert B). Generic Data Exemption cannot be
selected as an option for product specific data.

       If you are granted a Generic Data Exemption, you rely on the efforts of other
persons to provide the Agency with the required data. If the  registrant(s) who  have
committed to generate and submit the required data fail to take appropriate steps to
meet the requirements or are no longer in compliance with this Data Call-In Notice,
the Agency will consider that both they and  you are not in compliance and will
normally initiate proceedings to  suspend the  registrations of both your and  their
product(s),  unless you commit to submit and do submit the required data within the
specified time. In such cases the Agency generally will not grant a time extension for
submitting the data.

4.      Satisfying the Data Requirements of this Notice -  There are various options
available to satisfy the data requirements of this Notice.  These options are discussed
in  Section III-C of this Notice and comprise options 1 through 6 on the Requirements
Status and Registrant's Response Form (Insert B) and option 6b  and 7 on the  Data
Call-In Response Formdnsert A). If you choose option 6b or 7, you must submit both
forms as well as any other information/data pertaining to the option chosen to address
the data requirement.
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       5.      Request for Data Waivers. Data waivers are discussed in Section III-D of this
       Notice and are covered by options 8 and 9 on the Requirements Status and Registrant's
       Response Form (Insert B). If you choose one of these options, you must submit both
       forms as well as any other information/data pertaining to the option chosen to address
       the data requirement.

C.     SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

       If you acknowledge on the Data Call-In Response Form (Insert A) that you agree to
satisfy the data requirements (i.e. you select option 6b and/or 7), then you must select one of
the six options on the Requirements Status and Registrant's Response Form (Insert A) related
to data production for each data requirement. Your option selection should be entered under
item number 9, "Registrant Response."  The six options related to data production are the first
six options discussed under item 9 in the instructions for completing the Requirements Status
and Registrant's Response Form (Insert B). These six options are listed immediately below
with information in parentheses to guide registrants to additional instructions provided in this
Section. The options are:

       1.      I will generate and submit data within the specified time frame (Developing
              Data),

       2.      I have entered into an agreement with one or more registrants to develop data
             jointly (Cost Sharing),

       3.      I have made offers to cost-share (Offers to Cost Share),

       4.      I am submitting an existing study that has not been submitted previously to the
              Agency by anyone (Submitting an Existing Study),

       5.      I am submitting or citing data to upgrade a study classified by EPA as partially
              acceptable and upgradeable (Upgrading a Study),

       6.      I am citing an existing study that EPA has classified as acceptable or an
              existing study that has been submitted but not reviewed by the Agency (Citing
              an Existing Study).

       Option 1. Developing Data

              If you choose to develop the required data it must be in conformance with
       Agency deadlines and with other Agency requirements as referenced herein and in the
       attachments. All data generated and submitted must comply with the Good Laboratory
       Practice (GLP)  rule (40 CFR Part 160), be conducted according to the Pesticide
       Assessment Guidelines  (PAG), and be in conformance with the requirements of PR
       Notice 86-5. In addition, certain studies require Agency approval of test protocols in

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advance of study initiation. Those studies for which a protocol must be submitted
have been identified in the Requirements Status and Registrant's Response Form
(Insert B) and/or footnotes to the form.  If you wish to use a protocol which differs
from the options discussed in Section II-C of this Notice, you must submit a detailed
description of the proposed protocol and your reason for wishing to use it.   The
Agency may choose to reject a protocol not specified in Section II-C. If the Agency
rejects your protocol you will be notified in writing, however, you should be aware
that rejection of a proposed protocol will not be a basis for extending the deadline for
submission of data.

       A progress report must be submitted for each study within 90 days from the
date you are required to commit to generate or undertake some other means to address
that study requirement, such as making an offer to cost-share or agreeing to share in
the cost of developing that study. A 90-day progress report must be submitted for all
studies.  This 90-day progress report must include the date the study was or will be
initiated and, for studies to be started within 12 months of commitment, the name and
address of the laboratory(ies) or  individuals who are or will be conducting the study.
       In addition, if the time frame for submission of a final report is more than 1
year, interim reports must be submitted at 12 month intervals from the date you are
required to commit to generate or otherwise address the requirement for the study. In
addition to the other information specified in the preceding paragraph, at a minimum,
a brief description of current activity on and the status of the study must be included
as well as a full description of any problems encountered since the last progress report.

       The time frames in the Requirements Status and Registrant's Response Form
(Insert B) are  the time frames that the Agency is allowing for the submission of
completed study reports or protocols.  The noted deadlines run from the date of the
receipt of this Notice by the registrant. If the data are not submitted by the deadline,
each registrant is subject to receipt of a Notice of Intent to Suspend the affected
registration(s).

       If you cannot submit the data/reports to the Agency in the time required by this
Notice and intend to seek additional time to meet the requirement(s), you must submit
a request to the Agency which includes: (1) a detailed description of the expected
difficulty and (2) a proposed schedule including alternative dates for meeting such
requirements on a step-by-step basis.  You must explain any technical or laboratory
difficulties and provide documentation from the laboratory performing the testing.
While EPA is considering your request, the  original deadline remains. The Agency
will respond to your request in writing.  If EPA does  not grant your request, the
original deadline remains.  Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant.
Extensions will not be given in submitting the 90-day responses.  Extensions will not

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be considered if the request for extension is not made in a timely fashion; in no event
shall an extension request be considered if it is submitted at or after the lapse of the
subject deadline.

Option 2, Agreement to Share in Cost to Develop Data ~

       If you choose to enter into an agreement to share in the cost of producing the
required data but will not be submitting the data yourself, you must provide the name
of the registrant who will be submitting the data.  You must also provide EPA with
documentary evidence that an agreement has been formed.  Such evidence may be
your letter offering to join in an agreement and the other registrant's acceptance of your
offer, or a written statement by the parties that an agreement exists. The agreement to
produce the data need not specify all of the terms of the final arrangement between the
parties or the mechanism to resolve the terms. Section 3(c)(2)(B) provides that if the
parties cannot resolve the terms of the agreement they may resolve their differences
through binding arbitration.

Option 3. Offer to Share in the Cost of Data Development —

       If you have made an offer to pay in an attempt to enter into an agreement or
amend an existing agreement to meet the requirements of this Notice and have been
unsuccessful, you may request EPA (by selecting this option) to exercise  its discretion
not to suspend your registration(s), although you do not comply with the data
submission requirements of this Notice. EPA has determined that as a general policy,
absent other relevant considerations, it will not suspend the registration of a product
of a registrant who has in good faith sought and continues to  seek to enter into a joint
data development/cost sharing program, but the other registrant(s) developing the data
has refused  to accept your offer.   To qualify for this option,  you must submit
documentation to the Agency proving that you have made an offer to another registrant
(who has an  obligation to submit data) to share in the burden of developing that data.
You must also submit to the Agency a completed  EPA Form 8570-32,  Certification
of Offer to Cost Share in the Development of Data.  In addition, you must demonstrate
that the  other registrant to whom the offer was made has not accepted your offer to
enter into a cost sharing agreement by including a copy of your offer and proof of the
other registrant's receipt of that offer (such as a certified mail receipt). Your offer
must, in addition to anything else, offer to  share in the burden of producing the data
upon terms to be agreed or failing agreement to be bound by binding arbitration as
provided by  FIFRA section 3(c)(2)(B)(iii) and must not qualify this offer.  The other
registrant must also inform EPA of its election of an option to develop and submit the
data required by this Notice by submitting a Data  Call-In Response Form (Insert A)
and a Requirements  Status and Registrant's Response Form (Insert B) committing to
develop and submit the data required by this Notice.
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       In order for you to avoid suspension under this option, you may not withdraw
your offer to share in the burdens of developing the data.  In addition, the other
registrant must fulfill its commitment to develop and submit the data as required by
this Notice. If the other registrant fails to develop the data or for some other reason is
subject to suspension, your registration as well as that of the other registrant will
normally be subject to  initiation of suspension proceedings, unless you commit to
submit, and do submit the required data in the specified time frame.  In such cases, the
Agency generally will not grant a time extension for submitting the data.

Option 4. Submitting an Existing Study —

       If you choose to submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this Notice. You may
only submit a study that has not been  previously submitted to the Agency or
previously cited by anyone. Existing studies are studies which predate issuance of this
Notice. Do not use this option if you are submitting data to upgrade a study. (See
Option 5).

       You should be  aware that if the Agency determines that the study is not
acceptable, the Agency  will require you to comply with this Notice, normally without
an extension of the required date of submission. The Agency may determine at any
time that a study is not valid and needs to be repeated.

       To meet the requirements of the DCI Notice for submitting an existing study,
all of the following three criteria must be clearly met:

       a.   You must certify at the time that the existing study is submitted that the
       raw data and specimens from the study are available for audit and review and
       you must identify where they are available.  This must be done in accordance
       with the requirements of the Good Laboratory Practice (GLP) regulation, 40
       CFRPart 160. As stated in 40 CFR 160.3(7)" raw data means any laboratory
       worksheets, records, memoranda, notes, or exact copies thereof, that are the
       result of original observations and activities of a study and are necessary for
       the reconstruction and evaluation of the report of that study.  In the event that
       exact transcripts of raw data have been prepared (e.g., tapes which have been
       transcribed verbatim, dated, and verified accurate by signature), the exact copy
       or exact transcript may be substituted for the original source as raw data. Raw
       data may include photographs, microfilm  or microfiche copies, computer
       printouts, magnetic media, including dictated observations, and recorded data
       from automated instruments."  The term "specimens", according to 40 CFR
       160.3(7), means "any material derived from a test system for examination or
       analysis."

       b.  Health and safety studies completed after May 1984 must also contain all
       GLP-required quality assurance and quality control information, pursuant to

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       the requirements of 40 CFRPart 160. Registrants must also certify at the time
       of submitting the existing study that such GLP information is available for
       post-May 1984 studies by including an appropriate statement on or attached
       to the study signed by an authorized official or representative of the registrant.

       c.   You must certify that each study fulfills the acceptance criteria for the
       Guideline  relevant  to the  study provided  in the FIFRA Accelerated
       Reregistration Phase 3 Technical  Guidance and that the study  has been
       conducted according to the Pesticide Assessment Guidelines (PAG) or meets
       the purpose of the PAG (both available from NTIS).  A study not conducted
       according to the PAG may be submitted to the Agency for consideration if the
       registrant believes that the study clearly meets the purpose of the PAG.  The
       registrant is referred to 40 CFR 158.70 which states the Agency's policy
       regarding acceptable protocols. If you wish to submit the study, you must, in
       addition to certifying that the  purposes  of the PAG are met by the study,
       clearly articulate the rationale why you believe the study meets the purpose of
       the PAG, including copies of any supporting information or data. It has been
       the Agency's experience that studies completed prior to January 1970 rarely
       satisfied the purpose of the PAG and that necessary raw data are usually not
       available for such studies.

           If you  submit an existing study, you must certify that the study meets all
       requirements of the criteria outlined above.

           If EPA has previously reviewed a protocol for a study you are submitting,
       you must identify any action taken by the Agency on the protocol and must
       indicate,  as part of your  certification,  the manner in which all Agency
       comments,  concerns, or issues were addressed in the final protocol and study.

           If you know of a study pertaining to any requirement in this Notice which
       does not meet the criteria outlined above but does contain factual information
       regarding unreasonable adverse effects, you must notify the Agency of such a
       study. If such a study is in the Agency's files, you need only cite it along with
       the notification. If not in the Agency's files, you must submit a summary and
       copies as required by PR Notice 86-5.

Option 5. Upgrading a Study —

       If a study has been classified as partially acceptable and upgradeable, you may
submit data to upgrade that study.  The Agency will review the data submitted and
determine if the requirement is satisfied. If the Agency decides the requirement is not
satisfied, you may  still be required to  submit new data normally without any time
extension.   Deficient, but upgradeable  studies will  normally  be classified as
supplemental.  However, it is important to note that  not all studies classified as
supplemental are upgradeable. If you have questions regarding the classification of a

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       study or whether a study may be upgraded, call or write the contact person listed in
       Attachment 1.  If you submit data to upgrade an existing study you must satisfy or
       supply information to correct all deficiencies in the study identified by EPA. You
       must provide a  clearly  articulated rationale of how the deficiencies  have been
       remedied or corrected and why the study should be rated as acceptable to EPA.  Your
       submission must also specify the MRID number(s) of the study which you  are
       attempting to upgrade and must be in conformance with PR Notice 86-5.

              Do not submit additional data for the purpose of upgrading a study classified
       as unacceptable and determined by the Agency as not capable of being upgraded.

              This option should also be used to cite data that has been previously submitted
       to upgrade a study, but has not yet been reviewed by the Agency. You must provide
       the MRID number of the data submission as  well as the MRID number of the study
       being upgraded.

              The criteria for submitting an existing study, as specified in Option 4 above,
       apply to all data submissions intended to  upgrade studies.  Additionally your
       submission of data intended to upgrade studies must be accompanied by a certification
       that you comply with each of those criteria as well as a certification regarding protocol
       compliance with  Agency requirements.

       Option 6, Citing Existing Studies —

              If you choose to cite a study that has been previously submitted to EPA, that
       study must have been previously classified by EPA as acceptable or it must be a study
       which has not yet been reviewed by the Agency. Acceptable toxicology studies
       generally will have been classified as  "core-guideline"  or "core minimum."  For
       ecological effects studies, the classification generally would be a rating of "core." For
       all other disciplines the classification would be "acceptable." With respect to any
       studies for which you wish to select this option you must provide the MRID number
       of the study you are citing and, if the study has  been reviewed by the Agency, you must
       provide the Agency's classification of the study.

              If you are citing a study of which you are not the original data submitter, you
       must submit a completed copy of Certification with Respect to Citations of Data  (in
       PR Notice 98-5) EPA Form 8570-34  .

D.     REQUESTS FOR DATA WAIVERS

       There are two types of data waiver responses  to this Notice. The first is a request for
a low volume/minor use  waiver and the second is a waiver request based on your belief that
the data requirement(s) are inapplicable and do not apply to your product.
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1.      Low Volume/Minor Use Waiver — Option 8 on the Requirements Status and
Registrant's Response Form (Insert B).  Section 3(c)(2)(A) of FIFRA requires EPA to
consider the appropriateness of requiring data for low volume, minor use pesticides.
In implementing this provision EPA considers as low volume pesticides only those
active ingredient(s) whose total production volume for all pesticide registrants is
small. In determining whether to grant a low volume, minor use waiver the Agency
will consider the extent, pattern and volume of use, the economic incentive to conduct
the testing, the importance of the pesticide, and the exposure and risk from use of the
pesticide.  If an active ingredient(s) is used for both high volume and low volume uses,
a low volume exemption will not be approved. If all uses of an active ingredient(s) are
low volume and the combined volumes for all uses are also low, then an exemption
may be granted, depending on review of other information  outlined below.  An
exemption will not be granted if any registrant of the active ingredient(s) elects to
conduct the testing.  Any registrant receiving a low volume minor use waiver must
remain within the sales figures in their forecast supporting the waiver request in order
to remain qualified for such waiver. If granted a waiver, a registrant will be required,
as a condition of the waiver, to submit annual sales reports.  The Agency will respond
to requests for waivers in writing.

       To apply for a low volume, minor use waiver, you must submit the following
information, as applicable to your product(s), as part of your 90-day response to this
Notice:

       a.    Total company sales (pounds and dollars) of  all  registered product(s)
       containing the active ingredient(s). If applicable to the active ingredient(s),
       include foreign sales for those products that are not registered in this country
       but are applied to sugar (cane or beet), coffee, bananas,  cocoa, and other such
       crops.  Present the above information by year for each of the past five years.

       b.    Provide  an  estimate of the sales (pounds and dollars)  of the active
       ingredient(s) for each major use site. Present the above information by year for
       each of the past five years.

       c.    Total  direct  production  cost  of  product(s)  containing the active
       ingredient(s)  by year for the past five years.  Include information on raw
       material cost, direct labor cost, advertising, sales and marketing, and any other
       significant costs listed separately.

       d.    Total indirect production cost (e.g. plant overhead, amortized plant and
       equipment) charged to product(s) containing the active ingredient(s) by year
       for the past five years.  Exclude all non-recurring costs that were directly
       related to the active ingredient(s), such as costs of initial registration and any
       data development.
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              e.   A list of each data requirement for which you seek a waiver. Indicate the
              type of waiver sought and the estimated cost to you (listed separately for each
              data requirement and associated test) of conducting the testing needed to
              fulfill each of these data requirements.

              f   A list of each data requirement for which you are not seeking any waiver
              and the estimated cost to you (listed separately for each data requirement and
              associated test) of conducting the testing needed to fulfill  each of these data
              requirements.

              g.   For each of the next ten years, a year-by-year forecast of company sales
              (pounds and dollars) of the active ingredient(s), direct production costs of
              product(s)  containing the active ingredient(s) (following  the parameters in
              item c above), indirect production costs of product(s) containing the active
              ingredient(s) (following the parameters  in item d above), and  costs of data
              development pertaining to the active ingredient(s).

              h.   A description  of the  importance and  unique benefits of the  active
              ingredient(s) to users. Discuss the use patterns and the effectiveness of the
              active ingredient(s)  relative  to  registered  alternative  chemicals  and
              non-chemical  control strategies.   Focus on benefits  unique to the  active
              ingredient(s), providing information that is as quantitative as possible.  If you
              do not have quantitative data upon which to base your estimates, then present
              the reasoning used  to derive your  estimates.  To assist the Agency in
              determining the degree of importance of the active ingredient(s) in terms of its
              benefits, you should provide information on any of the following factors, as
              applicable to your product(s):

                  (1)        documentation of the usefulness of the active ingredient(s) in
              Integrated Pest Management, (b) description of the beneficial impacts on the
              environment of use of the active ingredient(s), as opposed to its registered
              alternatives, (c) information on the breakdown of the active ingredient(s) after
              use and on its persistence in the  environment, and (d)  description of its
              usefulness against a pest(s) of public health significance.

       Failure to submit  sufficient information for the Agency to make  a determination
regarding a request for a low volume minor use waiver will result in denial of the request for
a waiver.

       2.     Request for Waiver of Data  --Option  9 on the Requirements Status  and
       Registrant's Response Form (Insert B).  This option may be used if you believe that a
       particular  data requirement should not apply because the  corresponding  use is no
       longer registered or the requirement is  inappropriate.  You must submit a rationale
       explaining why you believe the data requirements should not apply.  You must also

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              submit the current  label(s) of your  product(s) and, if  a  current copy  of your
              Confidential Statement of Formula is not already on file you must submit a current
              copy.

                     You will be  informed of the Agency's decision in writing.  If the Agency
              determines that the data requirements of this Notice do not apply to your product(s),
              you will not be  required to supply the data pursuant to section 3(c)(2)(B).  If EPA
              determines that the data are required for your product(sX you must choose a method
              of meeting the requirements of this Notice within the time frame provided by this
              Notice.  Within  30 days of your receipt of the Agency's written decision, you must
              submit a revised Requirements Status and Registrant's Response Form (Insert B)
              indicating  the option chosen.

IV.    CONSEQUENCES OF  FAILURE TO COMPLY WITH THIS NOTICE

       A.     NOTICE OF INTENT TO SUSPEND

              The Agency may issue a Notice of Intent to Suspend products subject to this Notice
       due to failure by a registrant to comply with the requirements of this Data Call-In Notice,
       pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice
       of Intent to Suspend include, but are not limited to, the following:

              1.      Failure to respond as required by this Notice within 90 days of your receipt of
                     this Notice.

              2.      Failure to submit on the required schedule an acceptable proposed or final
                     protocol when such is required to be submitted to the Agency for review.

              3.      Failure to submit on the required schedule an adequate progress report on a
                     study as  required by this Notice.

              4.      Failure to submit on the required schedule acceptable data as required by this
                     Notice.

              5.      Failure to take a required action or submit adequate information pertaining to
                     any option chosen to address the data requirements (e.g., any required action
                     or information pertaining to submission or citation of existing studies or offers,
                     arrangements, or arbitration on the sharing of costs or the formation of Task
                     Forces, failure to  comply with the terms of an agreement  or arbitration
                     concerning joint data development or failure to comply with any terms of a
                     data waiver).

              6.      Failure to submit supportable certifications as to the conditions of submitted
                     studies, as required by Section III-C of this Notice.

              7.      Withdrawal of an offer to share in the cost of developing required data.
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       8.      Failure of the registrant to whom you have tendered an offer to share in the
              cost of developing data and provided proof of the registrant's receipt of such
              offer, or failure of a registrant on whom you rely for a generic data exemption
              either to:

              a.   inform EPA of intent to develop and submit the data required by this
              Notice on a Data Call-In Response Form (Insert A) and a Requirements Status
              and Registrant's Response Form (Insert B); or,

              b.   fulfill the commitment to develop and submit the data as required by this
              Notice; or,

              c.   otherwise take appropriate steps to meet the requirements stated in this
              Notice, unless you commit to submit and do submit the required data in the
              specified time frame.

       9.      Failure to take any required or appropriate steps, not mentioned above, at any
       time following the issuance of this Notice.
B.     BASIS   FOR  DETERMINATION   THAT   SUBMITTED   STUDY   IS
       UNACCEPTABLE

       The Agency may determine that a study (even if submitted within the required time)
is unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend.  The
grounds for suspension include, but are not limited to, failure to meet any of the following:

       1.      EPA requirements specified in the Data Call-In Notice or other documents
       incorporated by  reference (including, as applicable, EPA Pesticide  Assessment
       Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
       regarding the design, conduct, and reporting of required studies.  Such requirements
       include, but are not limited to, those relating to test material, test procedures, selection
       of species, number of animals, sex and distribution of animals, dose and effect levels
       to be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.

       2.      EPA requirements regarding the  submission of protocols, including  the
       incorporation of any changes  required by the Agency following review.

       3.      EPA requirements regarding  the reporting of data, including the manner of
       reporting, the completeness of results, and the adequacy of any required supporting (or
       raw) data,  including, but not limited to, requirements  referenced or included in this
       Notice or contained  in PR 86-5.  All studies must be submitted in the form of a final
       report; a  preliminary report will  not  be considered to fulfill the  submission
       requirement.

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       C.     EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS

              EPA has statutory authority to permit continued sale, distribution and use of existing
       stocks of a pesticide product which has been suspended or canceled if doing so would be
       consistent with the purposes of the Federal Insecticide, Fungicide, and Rodenticide Act.

              The Agency has determined that such disposition by registrants of existing stocks for
       a suspended registration when a section 3 (c)(2)(B) data request is outstanding would generally
       not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
       registrants permission to sell, distribute, or use existing stocks of suspended product(s) only
       in exceptional circumstances.  If you  believe such disposition of existing  stocks of your
       product(s)  which may be suspended  for failure to comply with this Notice should be
       permitted, you have the burden of clearly demonstrating to EPA that granting such permission
       would be consistent with the Act. You must also explain why an "existing stocks" provision
       is necessary, including a statement of the quantity of existing stocks and your estimate of the
       time required for their sale, distribution, and use.  Unless you meet this burden the Agency
       will not consider any request pertaining to the continued sale, distribution, or use of your
       existing stocks after suspension.

              If you request a voluntary cancellation of your product(s) as a response to this Notice
       and your product is  in full compliance with all Agency requirements, you will have, under
       most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
       distribute, or use existing stocks.  Normally, the Agency will allow persons other than the
       registrant such as independent distributors, retailers and end users to sell, distribute or use
       such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
       voluntarily canceled products containing an active ingredient(s) for which the Agency has
       particular risk concerns will be determined on case-by-case basis.

              Requests for voluntary cancellation received after the 90 day response period required
       by this Notice will not result in the  Agency granting any additional time to sell, distribute, or
       use existing stocks beyond a year from the date the 90 day response was due unless you
       demonstrate to the Agency that you are in full compliance with all Agency requirements,
       including the requirements of this Notice. For example, if you decide to voluntarily cancel
       your registration six months before a 3  year study is scheduled to be submitted, all progress
       reports and other information necessary to establish that you have been conducting the study
       in an acceptable and good faith manner must have been submitted to the Agency, before EPA
       will consider granting an existing stocks provision.

SECTION V.  REGISTRANTS' OBLIGATION TO  REPORT  POSSIBLE UNREASONABLE
              ADVERSE EFFECTS

       Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide
is registered a registrant has additional factual information regarding unreasonable adverse effects on
the environment  by the  pesticide, the registrant shall submit the  information to  the Agency.

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Registrants must notify the Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of studies, regarding unreasonable adverse
effects on man or the environment. This requirement continues as long as the products are registered
by the Agency.

SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the requirements  and procedures established by this
Notice, call the contact person listed in Attachment 1, the Data Call-In Chemical Status Sheet.

       All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form (Insert A) and a completed
Requirements Status and Registrant's Response Form (Insert B) and any other documents required by
this Notice, and should be submitted to the contact person identified in Attachment 1. If the voluntary
cancellation or generic data exemption option is chosen, only the Data Call-In Response Form (Insert
A) need be submitted.

       The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance
(OECA), EPA, will be monitoring the data being generated in response to this Notice.

                                                Sincerely yours,
                                               Lois A. Rossi, Director
                                               Special Review and
                                                 Reregistration Division
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IPRODIONE DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You have been sent this Generic Data Call-In Notice because you have product(s) containing
Iprodione.

       This Generic Data Call-In Chemical Status Sheet contains an overview of data required by
this notice, and point of contact for inquiries pertaining to the reregi strati on of Iprodione.  This
attachment is to be used in conjunction with (1) the Generic Data Call-In Notice, (2) the Generic Data
Call-In Response  Form (Attachment  2), (3) the Requirements Status  and Registrant's Form
(Attachment 2), (4) a list of registrants receiving this DCI (Attachment 4), (5) the EPA Acceptance
Criteria (Attachment 5), and (6) the Cost Share and Data Compensation Forms  in replying to this
Iprodione. Generic Data Call In (Attachment F).  Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE
       The additional data requirements needed to complete the generic database for Iprodione are
contained in the Requirements Status and Registrant's Response.  Attachment C. The Agency has
concluded that additional product chemistry data on Iprodione  are needed. These  data are needed
to fully complete the reregistration of all eligible Iprodione products.

INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the generic data requirements and procedures established
by this Notice, please contact Dennis Deziel at (703) 308-8173.

       All responsades to this Notice for the generic data requirements should be submitted to:

             Dennis Deziel, Chemical Review Manager
       Reregistration Branch
              Special Review and Registration Division (H7508W)
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C. 20460
             RE: Iprodione
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM
                                      (INSERT A)

       This Form is designed to be used to respond to call-ins for generic and product specific data
for the purpose of reregistering pesticides under the Federal Insecticide Fungicide and Rodenticide
Act. Fill out this form each time you are responding to a data call-in for which EPA has sent you the
form entitled "Requirements Status and Registrant's Response."

       Items  1-4 will have been preprinted on the form Items 5 through 7 must be completed by the
       registrant as appropriate Items 8 through  11 must be completed  by the registrant before
       submitting a response to the Agency.

       Public reporting burden for this collection of information is estimated to average  15 minutes
per response, including time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information.  Send
comments regarding the burden estimate or any  other aspect of this  collection of information,
including suggesting for reducing this burden, to Chief, Information Policy Branch, PM-223, U S
Environmental Protection Agency, 401 M St, S W ,  Washington, D C 20460; and to the Office of
Management and Budget, Paperwork Reduction Project 2070-0107, Washington, D C 20503.

INSTRUCTIONS

       Item 1.       This item identifies your company name, number and address.

       Item 2.       This item identifies the ease number, ease name, EPA chemical number and
                    chemical name.

       Item 3.       This item identifies the date and type of data call-in.

       Item 4.       This item identifies the EPA product registrations relevant to the data call-in.
                    Please note that you are also responsible for informing the Agency of your
                    response regarding any product that you believe may be covered by this data
                    call-in but that is not listed by the Agency in Item 4. You must bring any such
                    apparent omission to the Agency's  attention within the period required for
                    submission of this response form.

       Item 5.       Cheek this item for each product registration you wish to cancel voluntarily.
                    If a registration number is listed for a product for which you  previously
                    requested voluntary cancellation, indicate in Item 5 the date of that request.
                    You do not need to complete any item on the Requirements  Status and
                    Registrant's Response Form for any product that is voluntarily canceled.

       Item 6a.      Check this item if this data call-in is for generic data as indicated in Item 3 and
                    if you are eligible for a Generic Data Exemption for the chemical listed in Item
                    2 and used in the  subject product.  By electing this exemption, you agree to
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              the terms and conditions of a Generic Data Exemption as explained in the
              Data Call-In Notice.

              If you are eligible for or claim a Generic Data Exemption, enter the EPA
              registration Number of each registered source of that active ingredient that
              you use in your product.

              Typically, if you purchase an EPA-registered product from one or more other
              producers (who, with respect to the incorporated product, are in compliance
              with this and-any other outstanding Data Call-In Notice), and incorporate that
              product into all your products, you may complete this item for all products
              listed on this form If, however, you produce the active ingredient yourself, or
              use any unregistered product (regardless of the fact that some of your sources
              are registered), you may not claim a Generic Data Exemption and you may
              not select this item.

Item 6b.       Check this Item if the data call-in is a generic data call-in as indicated in Item
              3 and if you are agreeing to satisfy the generic data requirements of this data
              call-in.   Attach the Requirements Status and Registrant's Response Form
              (Insert A) that indicates how you will  satisfy those requirements.

Item 7a.       Check this  item if this call-in if a data call-in as indicated in Item 3 for a
              manufacturing use product (MUP), and if your product is a manufacturing use
              product for which you agree to supply product-specific data.  Attach  the
              Requirements Status and Registrants' Response Form (Insert A) that indicates
              how you will satisfy those requirements.

Item 7b.       Check this item if this call-in is a data call-in for an end use product (EUP) as
              indicated in Item 3 and if your product is an end use product for which you
              agree to supply product-specific data.  Attach the Requirements Status and
              Registrant's Response Form  (Insert A) that indicates  how you will satisfy
              those requirements.

Item 8.        This certification statement must be signed by an authorized representative of
              your company and the person signing must include his/her title.  Additional
              pages used in your response must be initialed and dated in the space provided
              for the certification.

Item 9.        Enter the date of signature.

Item 10.       Enter the name of the person EPA should contact with questions regarding
              your response.

Item 11.       Enter the phone number of your company contact.
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORM  (INSERTS)

Generic Data

This form is designed to be used for registrants to respond to call-in- for generic and product-specific
data as part of EPA's reregi strati on program under the Federal Insecticide Fungicide and Rodenticide
Act. Although the form is the same for  both product specific and generic data, instructions for
completing the forms differ  slightly.  Specifically,  options for satisfying product specific data
requirements do not include (1) deletion of uses or (2) request for a low volume/minor use waiver.
These instructions are for completion of generic data requirements.

EPA has developed this form individually for each data call-in addressed to each registrant, and has
preprinted this form with a number of items. DO NOT use this form for any other active ingredient.

Items 1 through 8 (inclusive) will have been preprinted on the  form. You must complete all other
items on this form by typing or printing legibly.

Public reporting burden for this collection of information is estimated to average 30 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed,  and completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of this collection of information,
including suggesting for reducing this burden, to Chief, Information Policy Branch, PM-223, U.S.
Environmental Protection Agency, 401 M St., SW., Washington, D.C. 20460; and to the Office of
Management and Budget, Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.

INSTRUCTIONS

Item 1.        This item identifies your company name, number, and address.

Item 2.        This item identifies the case number, case name, EPA chemical number and chemical
              name.

Item 3.        This item identifies the date and type of data call-in.

Item 4.        This item identifies the guideline reference numbers of studies required to support the
              product(s) being reregistered. These guidelines, in addition to requirements specified
              in the Data Call-In Notice, govern the conduct of the required studies.

Item 5.        This item identifies the study title associated with the guideline reference number and
              whether protocols and 1, 2, or 3-year progress reports  are required to be
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              submitted in connection with the study.  As noted in Section III of the Data Call-In
              Notice, 90-day progress reports are required for all studies.

                    If an asterisk appears in Item 5, EPA has attached information relevant to this
                    guideline reference number  to the Requirements  Status and Registrant's
                    Response Form (Insert B).

Item 6.        This item identifies the code associated with the use pattern of the pesticide. A brief
              description of each code follows:

                    A.                   Terrestrial food
                    B.                   Terrestrial feed
                    C.                   Terrestrial non-food
                    D.                   Aquatic food
                    E.                   Aquatic non-food outdoor
                    F.                   Aquatic non-food industrial
                    G.                   Aquatic non-food residential
                    H.                   Greenhouse food
                    I.                    Greenhouse non-food crop
                    J.                    Forestry
                    K.                   Residential
                    L.                   Indoor food
                    M.                   Indoor non-food
                    N.                   Indoor medical
                    O.                   Indoor residential

Item 7.        This item identifies the code assigned to the substance that must be used for testing.
              A brief description of each code follows.

                    EP                  End-Use Product
                    MP                  Manufacturing-Use Product
                    MP/TGAI            Manufacturing-Use Product  and  Technical  Grade
                                         Active Ingredient
                    PAI                 Pure Active Ingredient
                    PAI/M              Pure Active Ingredient and Metabolites
                    PAI/PAIRA          Pure Active Ingredient or Pure  Active  Ingredient
                                         Radiolabelled
                    PAIRA              Pure Active Ingredient Radiolabelled
                    PAIRA/M            Pure Active Ingredient Radiolabelled and Metabolites
                    PAIRA/PM          Pure  Active  Ingredient  Radiolabelled  and Plant
                                         Metabolites
                    TEP                       Typical End-Use Product
                    TEP _ *              Typical End-Use Product, Percent Active Ingredient
                                         Specified

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                    TEP/MET           Typical End-Use Product and Metabolites
                    TEP/PAI/M          Typical End-Use Product or Pure Active Ingredient
                                         and Metabolites
                    TGAI/PAIRA        Technical Grade Active Ingredient or Pure Active
                                         Ingredient Radiolabelled
                    TGAI                     Technical Grade Active Ingredient
                    TGAI/TEP           Technical Grade Active Ingredient or Typical End-Use
                                         Product
                    TGAI/PAI           Technical Grade Active Ingredient or Pure Active
                                         Ingredient
                    MET                      Metabolites
                    IMP                       Impurities
                    DEGR               Degradates
                    *See: guideline comment

Item 8.        This item identifies the time frame allowed for submission of the study or protocol
              identified in item 2. The time frame runs from the date of your receipt of the Data
              Call-In Notice.

Item 9.        Enter the appropriate Response Code or Codes to show how you intend to comply
              with each data requirement. Brief descriptions of each code follow. The Data Call-In
              Notice contains a fuller description of each of these options.

              1.     (Developing Data) I will conduct a new study and submit it within the time
                    frames specified in item 8  above. By indicating that I have chosen this option,
                    I certify that I will  comply with all the requirements pertaining to the
                    conditions for submittal of this study as outlined in the Data Call-In Notice
                    and that I will provide the protocol and progress reports required in item 5
                    above.

              2.     (Agreement to Cost Share) I have entered into an agreement with one or more
                    registrants to develop data jointly. By indicating that I have chosen this
                    option, I certify that I will comply with  all the requirements pertaining to
                    sharing in the cost of developing data as outlined in the Data Call-In Notice.

              3.     (Offer to Cost Share) I have made an offer to enter into an agreement with
                    one or more registrants to develop data jointly. I am submitting a copy of the
                    form "Certification of Offer to Cost Share in the Development of Data" that
                    describes this offer/agreement.  By indicating that I have chosen this option,
                    I certify that I will comply with all  the requirements pertaining to making an
                    offer to  share in the cost of developing data as outlined in the Data Call-In
                    Notice.
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              4.      (Submitting Existing Data) I am submitting an existing study that has never
                     before been submitted to EPA. By indicating that I have chosen this option,
                     I certify that this study meets all the requirements pertaining to the conditions
                     for submittal of existing data outlined in the Data Call-In Notice and I have
                     attached the needed supporting information along with this response.

              5.      (Upgrading a Study) I am submitting or citing data to upgrade a study that
                     EPA has classified as partially acceptable and potentially upgradeable. By
                     indicating that  I have chosen this option, I certify that I have met all the
                     requirements pertaining to the conditions for submitting or citing existing data
                     to upgrade a study described in the Data Call-In Notice. I am indicating on
                     attached correspondence the Master Record Identification Number (MRID)
                     that EPA has assigned to the data that I am citing as well as the MRID of the
                     study I am attempting to upgrade.

              6.      (Citing a Study) I am  citing  an existing  study that has been  previously
                     classified by EPA as acceptable, core, core minimum, or a study that has not
                     yet been reviewed by the Agency. I am providing the Agency's classification
                     of the study.

              7.      (Deleting Uses)  I  am  attaching an application for amendment to my
                     registration deleting the uses for which the data are required.

              8.      (Low Volume/Minor Use Waiver Request) I have read  the  statements
                     concerning low volume-minor use data waivers in the Data Call-In Notice and
                     I request a low-volume  minor use waiver of the data requirement.  I am
                     attaching a  detailed justification to support this waiver request including,
                     among  other things,  all information  required to support the  request. I
                     understand  that, unless modified  by the Agency  in  writing, the  data
                     requirement as stated in the Notice governs.

              9.      (Request for Waiver  of Data) I have read the statements concerning  data
                     waivers other than low volume minor-use data waivers in the Data Call-In
                     Notice  and I request  a waiver of the data requirement.  I am attaching an
                     identification of the basis for this waiver and a detailed justification to support
                     this waiver request.  The justification includes,  among  other  things, all
                     information required to support the request. I understand that, unless modified
                     by  the  Agency in writing, the data requirement as stated in the Notice
                     governs.

Item 10.       This item must be  signed by an authorized representative of your company. The
              person signing must include his/her title, and must initial and date all other pages of
              this form.
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Item 11.      Enter the date of signature.

Item 12.      Enter the name of the person EPA should contact with questions regarding your
             response.

Item 13.      Enter the phone number of your company contact.
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                   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                       WASHINGTON, D.C. 20460
                                                                            OFFICE OF
                                                                      PREVENTION, PESTICIDES
                                                                       AND TOXIC SUBSTANCES
                               DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency).  These data are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days after you receive this Notice you must
respond as set forth in Section III below.  Your response must state:

       1.     How you will comply with the requirements set forth in this Notice and its
             Attachments 1 through 5;  or

       2.     Why you believe you are exempt from the requirements listed in this Notice and in
             Attachment 3,  Requirements Status and Registrant's Response Form, (see section
             III-B); or

       3.     Why you believe EPA should not require your submission  of product specific data
             in the manner specified by this Notice (see section III-D).

       If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with
its requirements or should be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension.  We have provided a list of all of

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your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well as a list
of all registrants who were sent this Notice (Attachment 5).

       The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 03-31-99).

       This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:

       Section I   -  Why You Are Receiving This Notice
       Section II  -  Data Required By This Notice
       Section III -  Compliance With Requirements Of This Notice
       Section IV -  Consequences Of Failure To Comply With This Notice
       Section V  -  Registrants' Obligation To Report Possible Unreasonable Adverse
                    Effects
       Section VT -  Inquiries And Responses To This Notice

The Attachments to this Notice are:

       1 -   Data Call-In Chemical Status Sheet
       2 -   Product-Specific Data Call-In Response Form  (Insert A)
       3 -   Requirements Status and Registrant's Response Form (Insert B)
       4 -   EPA Batching of End-Use Products for Meeting Acute Toxicology Data
             Requirements for Reregistration
       5 -   List of Registrants Receiving This Notice

SECTIONI. WHY YOU ARE RECEIVING THIS NOTICE

       The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient.  The Agency has
concluded that the only additional data necessary are product specific data. No additional generic
data requirements are being imposed. You have been sent this Notice because you have product(s)
containing the subject active ingredient.

SECTION II. DATA REQUIRED BY THIS NOTICE

       II-A.  DATA REQUIRED

       The product specific data required by this Notice are specified in Attachment 3, Requirements
Status and Registrant's Response Form (Insert B). Depending on the results of the studies required in
this Notice, additional testing may be required.

       II-B.  SCHEDULE FOR SUBMISSION OF DATA
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   You are required to submit the data or otherwise satisfy the data requirements specified in Insert B,
Requirements Status and Registrant's Response Form (Insert BX within the time frames provided.

       II-C.   TESTING PROTOCOL

          All studies required under this Notice must be conducted in accordance with test standards
       outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have
       been established.

              These EPA Guidelines are available from the National Technical Information Service
       (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).

              Protocols approved by the Organization for Economic Cooperation and Development
       (OECD) are also acceptable if the OECD-recommended test standards conform to those
       specified in the Pesticide Data Requirements regulation (40 CFR ง 158.70).  When using the
       OECD protocols, they should be modified as appropriate so that the data generated by the
       study will satisfy the requirements of 40 CFR ง 158. Normally, the Agency will not extend
       deadlines for complying with data requirements when the studies were not conducted in
       accordance with acceptable standards.  The OECD protocols are available from OECD, 2001
       L Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone
       number 202-785-03 50).

              All new studies and proposed protocols submitted in response to this Data Call-In
       Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].

       II-D.   REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
              ISSUED BY THE AGENCY

          Unless  otherwise noted herein, this Data Call-In does not in any way supersede or change
       the requirements of any previous Data Call-In(sX or any other agreements entered into with
       the Agency pertaining to such prior Notice. Registrants must comply with the requirements of
       all Notices to avoid issuance of a Notice of Intent to Suspend their affected products.

SECTION III.      COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

       III-A.  SCHEDULE FOR RESPONDING TO THE AGENCY

              The appropriate responses initially required by this Notice for product specific data
       must be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
       adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
       Notice of Intent to Suspend (NOIS) affecting your products.  This and other bases for issuance
       of NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.

       III-B.  OPTIONS FOR RESPONDING TO THE AGENCY

              The options for responding to this Notice for product specific data are: (a) voluntary
       cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice
       or (c) request a data waiver(s).

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       A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section III-C. A discussion of
options relating to requests for data waivers is contained in Section III-D.

       There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the Data-
Call-in Response Form (Insert A), and the Requirements Status and Registrant's Response
Form (Insert B). The Data Call-In Response Form must be submitted as part of every response
to this Notice.  In addition, one copy of the Requirements Status and Registrant's Response
Form (Insert B) must be submitted for each product listed on the Data Call-In Response Form
(Insert A)  unless the voluntary cancellation option is selected or unless the product is
identical to another (refer to the instructions for completing the Data Call-In Response
Form(Insert A). Please note that the company's authorized representative is required to sign
the first page of the Data Call-In Response Form (Insert A) and Requirements Status and
Registrant's Response Form (Insert B), initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not alter the printed material.  If
you have questions or need assistance in preparing your response, call or write the contact
person(s) identified in Attachment 1.

1.     Voluntary  Cancellation - You may avoid the requirements of this Notice by
requesting voluntary cancellation of your product(s) containing the active ingredient that is
the subject of this Notice. If you wish to voluntarily cancel your product, you must submit a
completed Data Call-In Response Form (Insert AX indicating your election of this option.
Voluntary cancellation is item number 5 on the Data Call-In Response Form (Insert B). If you
choose this option, this is the only form that you are required to complete.

       If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.

2.     Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These
options are discussed in Section III-C of this Notice and comprise options 1 through 5 on the
Requirements Status and Registrant's Response Formdnsert A) and item numbers  7a and 7b
on the Data Call-In Response Formdnsert B). Deletion of a use(s) and the low volume/minor
use option are not valid options for fulfilling product specific data requirements.

3.     Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements
Status and Registrant's Response Form (Insert B).  If you choose one of these options, you
must submit both forms as well as any other information/data pertaining to the option chosen
to address the data  requirement.
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III-C  SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

       If you acknowledge on the Data Call-In Response Form (Insert A) that you agree to
satisfy the product specific data requirements (i.e. you select item number 7a or 7b), then you
must select one of the six options on the Requirements Status and Registrant's Response Form
(Insert A) related to data production for each data requirement.  Your option selection should
be entered under item number 9, "Registrant Response."  The six options related to data
production are the first six options discussed under item  9 in the instructions for completing
the Requirements  Status and Registrant's Response Formdnsert A). These six options are
listed immediately below with information in parentheses to guide registrants to additional
instructions provided in this Section. The options are:

(1)    I will generate and submit data within the specified time frame (Developing Data)
(2)    I have entered into an agreement with one or more registrants to develop data jointly
       (Cost Sharing)
(3)    I have made offers to cost-share (Offers to Cost Share)
(4)    I am submitting an existing study that has not been submitted previously to the
       Agency by anyone (Submitting an Existing Study)
(5)    I am submitting or citing data to upgrade a study classified by EPA as partially
       acceptable and upgradeable (Upgrading a Study)
(6)    I am citing an existing study that EPA has classified as acceptable or an existing study
       that has been submitted but not reviewed by the Agency (Citing an Existing Study)

Option 1, Developing Data ~ If you choose to develop the required data it  must be in
conformance with Agency deadlines and with other Agency requirements as referenced here
in and in the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFRPart 160), be conducted according to the Pesticide
Assessment Guidelines(PAG), and be in conformance with the requirements of PR Notice 86-
5.

       The time frames in the Requirements Status and Registrant's Response Form (Insert A)
are the time frames that the Agency is allowing for the submission of completed study reports.
The noted deadlines run from the date of the receipt of this Notice by the registrant. If the
data are not submitted by the deadline, each registrant is  subject to receipt of a Notice of
Intent to Suspend  the affected registration(s).

       If you cannot  submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to
the Agency which includes: (1)  a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis. You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing. While EPA is considering your  request, the
original deadline remains. The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally, extensions can be requested
only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
not be considered if the request for extension is not made in a timely fashion; in no event shall

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an extension request be considered if it is submitted at or after the lapse of the subject
deadline.

Option 2, Agreement to Share in Cost to Develop Data ~ Registrants may only choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products in the group. The registration number of the product for which data will be
submitted must be noted in the agreement to cost share by the registrant selecting this option.
If you choose to enter into an agreement to  share in the cost of producing the required data but
will not be submitting the data yourself, you must provide the name of the registrant who will
be submitting the data.  You must also provide EPA with documentary evidence that an
agreement has been formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to  produce the data need not specify all of the
terms of the final arrangement between the  parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they
may resolve their differences through binding arbitration.

Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an
offer to pay in an attempt to enter into an agreement or amend an existing agreement to meet
the requirements of this Notice and have been unsuccessful, you may request EPA (by
selecting this option) to exercise its discretion not to suspend your registration(s), although
you do not comply with the data submission requirements of this Notice.  EPA has determined
that as a general policy, absent other relevant considerations, it will not suspend the
registration of a product of a registrant who has in good faith sought and continues to seek to
enter  into a joint data development/cost sharing program, but the other registrant(s)
developing the data has refused to accept your offer. To qualify for this option, you must
submit documentation to the Agency proving that you have made an offer to another registrant
(who  has an obligation to submit data) to share in the burden of developing that data. You
must also submit to the Agency a completed EPA Form 8570-32, Certification of Offer to
Cost Share in the Development of Data, Attachment 7. In addition, you must demonstrate that
the other registrant to whom the offer was made has not accepted your offer to enter into a
cost sharing agreement by including a copy of your offer and proof of the other registrant's
receipt of that offer (such as a  certified mail receipt). Your offer must, in addition to anything
else, offer to share in the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii)
and must not qualify this offer.  The other registrant must also inform EPA of its election of
an option to develop and submit the data required by this Notice by submitting a  Data Call-In
Response Form (Insert A) and a Requirements Status and Registrant's Response Form (Insert
B) committing to develop and submit the data required by this Notice.

       In order for you to avoid suspension under this option, you may not withdraw your
offer to share in the burdens of developing the data. In addition, the other registrant must
fulfill its commitment to develop and submit the data as required by this Notice.  If the other
registrant fails to develop the data or for some other reason is subject to suspension, your

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registration as well as that of the other registrant will normally be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit the required data in the
specified time frame. In such cases, the Agency generally will not grant a time extension for
submitting the data.

Option 4, Submitting an Existing Study ~ If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed
by this Notice.  You may only submit a study that has not been previously submitted to the
Agency or previously cited by anyone.  Existing studies are studies which predate issuance of
this Notice.  Do not use this option if you are submitting data to upgrade a study.  (See Option
5).

       You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.

       To meet the requirements of the DCI Notice for submitting an existing study, all of
the following three criteria must be clearly met:

a.      You must certify at the time that the existing study is submitted that the raw data and
       specimens from the study are available for audit and review and you must identify
       where they are available.  This must be done in accordance with the requirements of
       the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in 40 CFR
       160.3(j)" 'raw data' means any laboratory worksheets, records, memoranda, notes, or
       exact copies thereof, that are the result of original observations and activities of a
       study and are necessary for the reconstruction and evaluation of the report of that
       study. In the event that exact transcripts of raw data have been prepared (e.g., tapes
       which have been transcribed verbatim, dated, and verified accurate by signature), the
       exact copy or exact transcript may be substituted for the original source as raw data.
       'Raw data' may include photographs, microfilm or microfiche copies, computer
       printouts, magnetic media, including dictated observations, and recorded data from
       automated instruments." The term "specimens", according to 40 CFR 160.3(k), means
       "any material derived from a test system for examination or analysis."

b.      Health and safety studies completed after May 1984 must also contain all  GLP-
       required quality assurance and quality control information, pursuant to the
       requirements of 40 CFR Part 160. Registrants must also certify at the time of
       submitting the existing study that such GLP information is available for post-May
       1984 studies by including an appropriate statement on or attached to the study signed
       by an authorized official or representative of the registrant.

c.      You must certify that each study fulfills the acceptance criteria for the Guideline
       relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
       Technical Guidance and that the study has been conducted according to the Pesticide
       Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
       NTIS).  A study not conducted according to the PAG may be submitted to the Agency

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       for consideration if the registrant believes that the study clearly meets the purpose of
       the PAG. The registrant is referred to 40 CFR 158.70 which states the Agency's policy
       regarding acceptable protocols. If you wish to submit the study, you must, in addition
       to certifying that the purposes of the PAG are met by the study, clearly articulate the
       rationale why you believe the study meets the purpose of the PAG, including copies of
       any supporting information or data. It has been the Agency's experience that studies
       completed prior to January 1970 rarely satisfied the purpose of the PAG and that
       necessary raw data are usually not available for such studies.

       If you submit an existing study, you must certify that the study meets all requirements
of the criteria outlined above.

       If you know of a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency of such a study. If such study is in the Agency's
files, you need only cite it along with the notification. If not in the Agency's files, you must
submit a summary and copies as required by PR Notice 86-5.

Option 5, Upgrading a Study ~ If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study.  The Agency will review the data
submitted and determine if the requirement is satisfied.  If the Agency decides the requirement
is not satisfied, you may still be required to submit new data normally without any time
extension. Deficient, but upgradeable studies will normally be classified as supplemental.
However, it is important to note that not all studies classified as supplemental are
upgradeable.  If you have questions regarding the classification of a study or whether a study
may be upgraded, call or write the contact person listed in Attachment 1.  If you submit data to
upgrade an existing study you must satisfy or supply information to correct all deficiencies  in
the study identified by EPA. You must provide a clearly articulated rationale of how the
deficiencies have been remedied or corrected and why the study should be rated as  acceptable
to EPA.  Your submission must also specify the MRID number(s) of the study which you are
attempting to upgrade and must be in conformance with PR Notice 86-5.

       Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.

       This option should also be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded.

       The criteria for submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with each
of those criteria as well as a certification regarding protocol compliance with Agency
requirements.

Option 6, Citing Existing Studies ~ If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it

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       must be a study which has not yet been reviewed by the Agency.  Acceptable toxicology
       studies generally will have been classified as "core-guideline" or "core minimum." For all
       other disciplines the classification would be "acceptable." With respect to any studies for
       which you wish to select this option you must provide the MRID  number of the study you are
       citing and, if the study has been reviewed by the Agency, you must provide the Agency's
       classification of the study.

              If you are citing a study of which you are not the original data submitter, you must
       submit a completed copy of EPA Form 8570-34, Certification with Respect to Citations of
       Data (in PR Notice 98-51.

              Registrants who select one of the above 6 options must meet all of the requirements
       described in the instructions for completing the Data Call-In Response Form (Insert A) and
       the Requirements Status and Registrant's Response Form (Insert B), as appropriate.

       III-D.  REQUESTS FOR DATA WAIVERS

              If you request a waiver for product specific data because you believe it is
       inappropriate, you must attach a complete justification for the request, including technical
       reasons, data and references to relevant EPA regulations, guidelines or policies.  (Note: any
       supplemental data must be submitted in the format required by PR Notice 86-5). This will be
       the only opportunity to state the reasons or provide information in support of your request. If
       the Agency approves your waiver request, you will not be required to supply the data pursuant
       to section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
       option for meeting the data requirements of this Notice within 30 days of the receipt of the
       Agency's decision.  You must indicate and submit the option chosen on the Requirements
       Status and Registrant's Response Form. Product specific data requirements for product
       chemistry, acute toxicity and efficacy (where appropriate) are required for all products and the
       Agency would grant a waiver only under extraordinary circumstances. You should also be
       aware that submitting a waiver request will not automatically extend the due date for the study
       in question. Waiver requests submitted without adequate supporting rationale will be denied
       and the original due date will remain in force.

IV.    CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

       IV-A  NOTICE OF INTENT TO SUSPEND

              The Agency may issue a Notice of Intent to Suspend products subject to this Notice
       due to failure by a registrant to comply with the requirements of this Data Call-In Notice,
       pursuant to FIFRA section 3(c)(2)(B).  Events which may be the basis for issuance of a Notice
       of Intent to Suspend include, but are not limited to, the following:

       1.      Failure to respond as required by this Notice within 90 days of your receipt of this
              Notice.

       2.      Failure to submit on the required schedule an acceptable proposed or final protocol
              when such is required to be submitted to the Agency for review.

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3.      Failure to submit on the required schedule an adequate progress report on a study as
       required by this Notice.

4.      Failure to submit on the required schedule acceptable data as required by this Notice.

5.      Failure to take a required action or submit adequate information pertaining to any
       option chosen to address the data requirements (e.g., any required action or
       information pertaining to submission or citation of existing studies or offers,
       arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
       failure to comply with the terms of an agreement or arbitration concerning joint data
       development or failure to comply with any terms of a data waiver).

6.      Failure to submit supportable certifications as to the conditions of submitted studies,
       as required by Section III-C of this Notice.

7.      Withdrawal of an offer to share in the cost of developing required data.

8.      Failure of the registrant to whom you have tendered an offer to share in the  cost of
       developing data and provided proof of the registrant's receipt of such offer or failure of
       a registrant on whom you rely for a generic data exemption either to:

       a.      inform EPA of intent to develop and submit the data required by this Notice on
              a Data Call-In Response Formdnsert A) and a Requirements Status and
              Registrant's Response Formdnsert B):

       b.     fulfill the commitment to develop and submit the data as required by this
              Notice; or

       c.      otherwise take appropriate  steps to meet the requirements stated in this Notice,
              unless you commit to submit and do submit the required data in the specified
              time frame.

9.      Failure to take any required or appropriate steps, not mentioned above, at any time
       following the issuance of this Notice.

IV-B.  BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
       UNACCEPTABLE

       The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend.   The
grounds for suspension include,  but are not limited to, failure to meet any of the following:

1.  EPA requirements specified in the Data Call-In Notice or other documents incorporated by
reference (including,  as applicable, EPA Pesticide Assessment Guidelines, Data Reporting
Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design, conduct, and
reporting of required studies.  Such requirements include, but are not limited to, those relating
to test material, test procedures,  selection of species, number of animals, sex and distribution

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of animals, dose and effect levels to be tested or attained, duration of test, and, as applicable,
Good Laboratory Practices.

2.  EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.

3.  EPA requirements regarding the reporting of data,  including the manner of reporting, the
completeness of results, and the adequacy of any required supporting (or raw) data, including,
but not limited to, requirements referenced or included in this Notice or contained in PR 86-5.
All studies must be submitted in the form of a final report; a preliminary report will not be
considered to fulfill the submission requirement.

IV-C  EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS

       EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or canceled if doing so would be
consistent with the purposes  of the Act.

       The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally
not be consistent with the Act's purposes.  Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
exceptional circumstances. If you believe such disposition of existing stocks of your
product(s) which may be suspended for failure to comply with this Notice should be
permitted, you have the burden of clearly demonstrating to EPA that granting such permission
would be consistent with the Act. You must also explain why an "existing stocks" provision is
necessary, including a statement of the quantity of existing stocks and your estimate of the
time required for their sale, distribution, and use.  Unless you meet this burden the Agency
will not consider any request pertaining to the continued  sale, distribution, or use of your
existing stocks after suspension.

       If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily canceled products containing an active ingredient for which the Agency has
particular risk  concerns will be determined on case-by-case basis.

       Requests for voluntary cancellation received after the 90 day response period required
by this Notice  will not result in the Agency granting any additional time to sell, distribute, or
use existing stocks beyond a  year from the date the 90 day response was due unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a  3 year study is scheduled to be submitted, all progress
reports and other information necessary to establish that you have been conducting the study

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in an acceptable and good faith manner must have been submitted to the Agency, before EPA
will consider granting an existing stocks provision.

SECTION V. REGISTRANTS' OBLIGATION TO REPORT
             POSSIBLEUNREASONABLE ADVERSE EFFECTS

       Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency.  Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies,
regarding unreasonable adverse effects on man or the environment. This requirement
continues as long as the products are registered by the Agency.

SECTION VI.       INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status
Sheet.
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              All responses to this Notice (other than voluntary cancellation requests and generic
       data exemption claims) must include a completed Data Call-In Response Form (Insert A) and
       a completed Requirements Status and Registrant's Response Form (Insert B) for product
       specific data) and any other documents required by this Notice, and should be submitted to
       the contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
       exemption option is chosen, only the Data Call-In Response Form (Insert A) need be
       submitted.

              The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
       Substances (OPTS), EPA, will be monitoring the data being generated in response to this
       Notice.

                                         Sincerely yours,
                                         Lois A. Rossi, Director
                                         Special Review and
                                          Reregistration Division
Attachments
       1 -    Data Call-In Chemical Status Sheet
       2 -    Product-Specific Data Call-In Response Form (Insert A)
       3 -    Requirements Status and Registrant's Response Form (Insert B)
       4 -    EPA Batching of End-Use Products for Meeting Acute Toxicology Data Requirements
              for Reregistration
       5 -    List of Registrants Receiving This Notice
                                            247

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248

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IPRODIONE DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing Iprodione.

       This Product Specific Data Call-In Chemical Status Sheet contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregi strati on of Iprodione.  This
attachment is to be used in conjunction with (1) the Product Specific Data Call-In Notice,  (2) the
Product Specific Data Call-In  Response Form  (Attachment 2), (3) the Requirements Status  and
Registrant's Form (Attachment 3), (4) EPA's Grouping of  End-Use Products for Meeting Acute
Toxicology Data Requirement (Attachment 4), (5) the EPA  Acceptance Criteria (Attachment 5), (6) a
list of registrants receiving this DCI (Attachment 6) and (7) the Cost Share  and Data Compensation
Forms in replying to this Iprodione Product Specific Data  Call-In (Attachment 7).  Instructions and
guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

       The additional data requirements needed to complete the database for Iprodione are contained
in the Requirements Status and Registrant's Response. Attachment 3. The Agency has concluded that
additional data on Iprodione are needed for specific products.  These data are  required to be submitted
to the Agency within the time frame listed.  These data are needed to fully complete the reregi strati on
of all eligible Iprodione products.

INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any  questions regarding this product specific data requirements and procedures
established by this Notice, please contact Frank Rubis at (703) 308-8184 .

       All responses to this Notice for the Product Specific  data requirements should be submitted to:

             Chemical Review Manager Team 81
             Product Reregi strati on Branch
             Special Review and Reregistration Branch 7508W
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C. 20460

             RE: Iprodione
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  INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
                              PRODUCT SPECIFIC DATA

Item 1-4.     Already completed by EPA.

Item 5.       If you wish to voluntarily cancel your product, answer "yes." If you choose this option,
             you will not have to provide the data required by the Data Call-In Notice and you will
             not have to complete any other forms. Further sale and distribution of your product after
             the effective date of cancellation must be in accordance with the Existing  Stocks
             provision of the Data Call-In Notice (Section IV-C).

Item 6.       Not applicable since this form calls  in product specific data only. However,  if your
             product is identical to another product and you qualify for a data exemption, you must
             respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the EPA
             registration numbers of your source(s); you would not complete the "Requirements
             Status and Registrant's Response" form. Examples of such products include repackaged
             products and Special Local  Needs (Section 24c) products which  are identical to
             federally registered products.

Item 7a.      For each manufacturing use product (MUP)  for which you wish to maintain
             registration, you must agree to satisfy the data requirements by responding "yes."

Item 7b.      For each end use product (EUP) for which you wish to maintain registration, you must
             agree to satisfy the data requirements by responding "yes." If you are requesting a data
             waiver, answer "yes" here; in addition, on the "Requirements Status and Registrant's
             Response" form under Item 9, you must respond with Option 7 (Waiver Request) for
             each study for which you are requesting a waiver.  See Item 6 with regard to identical
             products and data exemptions.

Items 8-11. Self-explanatory.

NOTE:      You may provide additional information that does not fit on this form in a signed letter
             that accompanies this form. For example, you may wish to report that your product has
             already  been transferred to another  company or that you have  already voluntarily
             canceled this product. For these cases, please supply all relevant details so that EPA can
             ensure that its records are correct.
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             Sample Response Form for the Product Specific Data Call-In(Form A)

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sample Part A form page number 1 in the actual Printed version of the Red document.
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        INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
          REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA

Item 1-3     Completed by EPA. Note the unique identifier number assigned by EPA in Item 3.
             This number must be used in the transmittal document for any data submissions in
             response to this Data Call-In Notice.

Item 4.       The guideline reference numbers of studies required to support the product's continued
             registration are identified. These guidelines, in addition to the requirements specified in
             the Notice, govern the conduct of the required studies. Note that series 61 and 62 in
             product chemistry are now listed under 40 CFR 158.155 through 158.180, Subpart C.

Item 5.       The study title associated with the guideline reference number is identified.

Item 6.       The use pattern(s) of the pesticide associated with the product specific requirements is
             (are) identified.  For most product specific data requirements, all use patterns are covered
             by the data requirements. In the case of efficacy data, the required studies only pertain
             to products which have the use sites and/or pests indicated.

Item 7.       The substance to be tested is identified by EPA.  For product specific data, the product
             as formulated for sale and distribution is the test substance, except in rare cases.

Item 8.       The due date for submission of each study is identified. It is normally based on 8 months
             after issuance of the Reregistration Eligibility Document unless EPA determines that
             a longer time period is necessary.

Item 9.       Enter only one of the following response codes for each data requirement to show
             how you intend to comply with the data requirements listed in this  table.  Fuller
             descriptions of each option are contained in the Data Call-In Notice.

       1.     I will generate  and submit  data by the specified  due date (Developing Data).  By
             indicating that I have chosen this  option, I  certify that I will comply with all the
             requirements pertaining to the conditions for submittal of this study as outlined in the
             Data  Call-In Notice. By the  specified due date, I will also submit:  (1) a completed
             "Certification with Respect to Citations of Data (in PR Notice 98-5)" form (EPA
             Form 8570-34) and (2) two  completed and signed copies  of the Confidential
             Statement of Formula (EPA Form 8570-4)

       2.     I have entered into an agreement with one or more registrants to develop data jointly
             (Cost Sharing). I am submitting a copy of this agreement.  I understand that this
             option is available only for acute toxicity or certain efficacy data and only  if EPA
             indicates in an attachment to this Notice that my product is similar enough to another
             product to qualify for this  option.   I certify that another party in the  agreement is
             committing to submit or provide the required data; if the required study is not submitted
             on time, my product may be  subject to suspension. By the specified due date, I will also


                                           252

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       submit: (1) a completed "Certification with Respect to Citations of Data  (in PR
       Notice 98-5)" form (EPA Form 8570-34) and (2) two completed and signed copies of
       the Confidential Statement of Formula (EPA Form 8570-4)

3.      I have made offers to share in the cost to develop data (Offers to Cost Share). I
       understand that this option is available only for acute toxicity or certain efficacy data and
       only if EPA indicates in an attachment to this Data Call-In Notice that my product is
       similar enough to another product to qualify for this option. I am submitting evidence
       that I have made an offer to another registrant (who has an obligation to submit data)
       to share in the cost of that data. I am also submitting a completed "Certification of
       Attempt to Enter into an Agreement with other Restraints for Development of
       Data " (EPA Form 8570-32). I am including a copy of my offer and proof of the other
       registrant's receipt of that offer. I am identifying the party which is committing to submit
       or provide the required data; if the required study is not submitted on time, my product
       may be subject to suspension. I understand that other terms under Option 3 in the Data
       Call-In Notice (Section III-C.l.) apply as well. By the specified due date, I will also
       submit: (1)  a completed "Certification With Respect To  Data Compensation
       Requirements" form (EPA Form 8570-34) and (2) two completed and signed copies
       of the Confidential Statement of Formula (EPA Form 8570-4)

4.      By the specified due date, I will submit an existing study that has not been submitted
       previously to the Agency by anyone (Submitting an Existing Study). I certify that this
       study will meet all the requirements for submittal of existing data outlined in Option 4
       in the  Data  Call-In Notice  (Section III-C.l.) and will meet the attached acceptance
       criteria (for acute toxicity  and product chemistry  data).  I will  attach the needed
       supporting information along with this response. I also certify that I have determined
       that this study will fill the data requirement for which I have indicated this choice.  By
       the specified due date, I will also submit a completed "Certification With Respect To
       Data Compensation Requirements" form (EPA Form 8570-34) to show what data
       compensation option I have chosen. By the specified due date, I will also submit: (1) a
       completed "Certification With Respect To  Data Compensation Requirements"
       form  (EPA  Form  8570-34)  and (2) two completed and  signed copies of  the
       Confidential Statement of Formula (EPA Form 8570-4)

5.      By the specified due date, I will submit or cite data to upgrade a study classified by the
       Agency as partially acceptable  and upgradable (Upgrading a  Study).  I will submit
       evidence of the Agency's review indicating that the study may be  upgraded and what
       information is required to do so. I will provide the MRID or Accession number of the
       study at the due date. I understand that the conditions for this option outlined Option
       5 in the Data Call-In Notice (Section III-C.l.) apply.  By the specified due date, I will
       also submit: (1) a completed "Certification With Respect To Data Compensation
       Requirements" form (EPA Form 8570-34) and (2) two completed and signed copies
       of the Confidential Statement of Formula (EPA Form 8570-4)
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       6.     By the specified due date, I will cite an existing study that the Agency has classified as
             acceptable or an existing study that has been submitted but not reviewed by the Agency
             (Citing an Existing Study). If I am citing another registrant's study, I understand that
             this option is available only for acute toxicity or certain efficacy data and only if the cited
             study was conducted on my product, an identical product or a product which EPA has
             "grouped" with one or more other products for purposes of depending on the same data.
             I may also choose this option if I am citing my own data. In either case, I will provide
             the MRID or Accession number(s) for the cited data on a "Product Specific Data
             Report" form or in a similar format. By the specified due date, I will also submit: (1) a
             completed "Certification With Respect To Data Compensation Requirements"
             form (EPA  Form  8570-34) and  (2) two completed and signed copies of the
             Confidential Statement of Formula (EPA Form 8570-4)

       7.     I request a waiver for this study because it is inappropriate for my product (Waiver
             Request). I am attaching a complete justification for this request, including technical
             reasons, data and references to relevant EPA regulations, guidelines or policies. [Note:
             any supplemental data must be submitted in the format required by P.R. Notice 86-5].
             I understand that this is my only opportunity to state the reasons or provide information
             in support of my  request.  If the Agency  approves  my waiver request, I will not be
             required to supply the data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency
             denies my waiver request, I must choose a method of meeting the data requirements of
             this Notice by the due date stated by this Notice. In this case, I must, within 30 days of
             my receipt of the Agency's written decision, submit a revised "Requirements Status and
             Registrant's Response"  Form indicating the option chosen.  I also understand that the
             deadline for submission of data as  specified by the original data call-in notice will not
             change. By the specified due date, I will also submit: (1) a completed "Certification
             With Respect To Data Compensation Requirements" form (EPA Form 8570-34)
             and (2) two completed  and signed  copies of the Confidential Statement of Formula
             (EPA Form 8570-4)

Items 10-13.  Self-explanatory.

NOTE:      You may provide additional information that does not fit on this form in a signed letter
             that accompanies this form. For example, you may wish to report that your product has
             already been transferred to another company or that  you have already voluntarily
             canceled this product. For these cases, please supply all relevant details so that EPA can
             ensure that its records are correct.
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Sample Requirements Status and Registrant's Response Form for the Product Specific Data Call-
In(Form B)

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sample Part B form page number 1 in the actual Printed version of the Red document
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sample Part B form page number 2 in the actual Printed version of the Red document
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sample Part B form page number 3 in the actual Printed version of the Red document
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sample Part B form page number 4 in the actual Printed version of the Red document
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EPA'S BATCHING OF IPRODIONE PRODUCTS FOR MEETING ACUTE TOXICITY DATA
REQUIREMENTS FOR REREGISTRATION

       In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregi strati on of products containing iprodione 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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       Twenty products were found which contain Iprodione as an active ingredient. These products
have been placed into three batches and a "no batch" category in accordance with the expected acute
toxicity of the active and inert ingredients. Products in batch la and Ib may share all acute data except
eye irritation and dermal sensitization. Products in batch 2 may be supported by category III/IV acute
oral, acute dermal and acute inhalation data performed with the technical. The products in batch 3 may
be supported by acute data on the source products in accordance with the Agency policy on the acute
toxicity data requirements for granular pesticide products including fertilizer pesticide products.

The following "no batch" products may cite acute data as follows:

- EPA Reg. No. 264-558 may be supported by batch la for all acutes except dermal sensitization and/or
batch Ib for all acutes except eye irritation.

- EPA Reg. No. 538-182 may be supported by acute toxicity data on the source product in accordance
with the Agency policy on the acute toxicity data requirements for granular pesticide products including
fertilizer pesticide products.

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
la
EPA Reg. No.
264-453
264-481
264-532
% Active Ingredient
50.0
50.0
50.0
Formulation Type
Solid
Solid
Solid
Batch
Ib
EPA Reg. No.
264-524
264-527
% Active Ingredient
50.0
50.0
Formulation Type
Solid
Solid
Batch
2
EPA Reg. No.
264-482
264-520
264-562
264-563
% Active Ingredient
41.6
41.6
41.6
41.6
Formulation Type
Liquid
Liquid
Liquid
Liquid
Batch
O
EPA Reg. No.
538-194
538-217
% Active Ingredient
1.02
1.02
Formulation Type
Solid
Solid
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No
Batch

EPA Reg. No.
264-452
264-480
264-483
264-558
264-571
538-159
538-182
538-183
2792-64
% Active Ingredient
95
24
30
50.0
14
1.30
1.59
19.65
33.33
Formulation Type
Solid
Liquid
Liquid
Solid
Liquid
Solid
Solid
Liquid
Solid
261

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List of Registrants page number 1 in the actual Printed version of the Red document
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Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO I/forms/.

Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)

Instructions

    1.  Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on
       your computer then printed.)
    2.  The completed form(s) should be submitted in hardcopy in accord with the existing policy.
    3.  Mail  the forms,  along  with any additional documents necessary to comply with EPA
       regulations covering your request, to the address below for the Document Processing Desk.
       DO NOT fax  or e-mail any form containing 'Confidential Business Information'
       or 'Sensitive Information.'

  If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551
or by e-mail atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide
Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State
Registration of a Pesticide To Meet a Special
Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an
Agreement with other Restraints for
Development of Data
Certification with Respect to Citations of Data
(in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties
(in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice
98-1)
http://www.epa.gov/opprd001/forms/8570-l.pdf.

http://www.epa.gov/opprd001/forms/8570-4.pdf.

http://www.epa.gov/opprd001/forms/8570-5.pdf.

http://www.epa. gov/opprdOO l/forms/8570- 1 7.pdf.
http://www.epa.gov/opprd001/forms/8570-25.pdf.

http://www.epa.gov/opprd001/forms/8570-27.pdf.

http://www.epa.gov/opprd001/forms/8570-28.pdf.

http://www.epa.gov/opprd001/forms/8570-30.pdf.

http://www.epa.gov/opprd001/forms/8570-32.pdf.

http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf.

http://www.epa.gov/opppmsdl/PR_Notices/pr98-5.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf.

http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf.

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Pesticide Registration Kit         www.epa.gov/pesticides/registrationkit/.

   Dear Registrant:

   For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental
Protection Agency's Office of Pesticide Programs (OPP):

    1.  The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug
       and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of 1996.
    2.  Pesticide Registration (PR) Notices
       a      83-3 Label Improvement Program—Storage and Disposal Statements
       b.      84-1 Clarification of Label Improvement Program
       c.      86-5 Standard Format for Data Submitted under FIFRA
       d.      87-1 Label Improvement Program for Pesticides Applied through Irrigation  Systems
              (Chemigation)
       e.      87-6 Inert Ingredients in Pesticide Products Policy Statement
       f      90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
       g.      95-2 Notifications,  Non-notifications, and Minor Formulation Amendments
      h.       98-1 Self Certification of Product Chemistry Data with Attachments (This document is
              in PDF format and  requires the Acrobat reader.)
      Other PR Notices can be found at http://www.epa.gov/opppmsdl/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
                    Biopesticides  and Pollution Prevention Division (BPPD) Contacts
              Antimicrobials Division Organizational Structure/Contact List
       c.      53 F.R.  15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF
              format)
       d.      40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
       e.      40 CFR Part 158, Data Requirements for Registration (PDF format)
       f.      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

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    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)
       the following address:
         National Technical Information Service (NTIS)
         5285 Port Royal Road
         Springfield, VA 22161

       The telephone number for NTIS is (703) 487-4650. Please note that EPA is currently in the
process of updating this booklet to reflect the changes in the registration program resulting from the
passage of the FQPA and the reorganization of the Office of Pesticide Programs. We anticipate that this
publication will become available during the Fall of 1998.
   3.   The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for
       Environmental and Regulatory Information Systems.  This service does charge a  fee for
       subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614 or
       through their Web site.
  4.   The National Pesticide Telecommunications Network (NPTN) can  provide information on active
       ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone
       at 1-800-858-7378 or through their Web site.

  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
      the 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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                       Documents Associated with this RED

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

       1. Health and Environmental Effects Science Chapters.

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