United States      Prevention, Pesticides
Environmental Protection  And Toxic Substances
Agency        (7508C)
                   EPA738-R-02-005
                   June 2002
        Reregistration
E||g|bimy Decision (IRED)
      Ethoprop

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                     United States
                     Environmental Protection
                     Agency
Prevention, Pesticides
ancl Toxic Substances
(75O8C)
EPA 738-F-O2-OO4
June 2OO2
&EPA     Ethoprop  Facts
              EPA has assessed the risks posed by fee use of the active ingredient ethoprop, and
        reached an Interim Reregistiation Eligibility Decision (KED) for this organophosphate (OP)
        pesticide. Provided that risk mitigation measures are adopted, EPA has made the determination
        that ethoprop fits into its own "risk cup"- that is, its individual and aggregate risks are within
        acceptable levels, provided the stipulated risk mitigation measures are implemented. Thus,
        ethoprop products, except for fee liquid formulation, are eligible for ^registration, pending
        consideration of fee cumulative risk for allOPs. The Agency will make a reregistration
        eligibility decision for fee liquid formulation at a later time, provided certain conditions are
        fulfilled.
               Efeoprop residues in food do not pose risk
         concerns. Although there is concern for drinking water
         risks based on estimates from screening-level water
         modeling, fee Agency believes actual drinking water
         exposures are much lower and are not of concern. Wife
         fee implementation of a variety of risk reduction
         measures, efeoprop's worker and ecological risks will be
         substantially reduced. Also, efeoprop has no residential
         uses, and its use on golf course turf has been voluntarily
         canceled.

               EPA is reviewing fee OP pesticides to determine
         whether they meet current health and safety standards.
         Older OPs need decisions about their eligibility for
         reregistration under fee Federal Insecticide, Fungicide,
         and Rodenticide Act (FIFRA). OPs wife residues in
         food, drinking water, and other non-occupational
         exposures also must be reassessed to make sure they
         meet fee new Food Quality Protection Act (FQPA)
         safety standard.
                 The OP Pilot Public Participation Process

                    The organophosphates are a group of
              related pesticides that affect the functioning of the
              nervous system. They are among EPA's highest
              priority for review under the Food Quality
              Protection Act.
                    EPA is encouraging the public to
              participate in the review of the OP pesticides.
              Through a six-phased pilot public participation
              process, the Agency is releasing for review and
              comment its preliminary and revised scientific risk
              assessments for individual OPs.  (Please contact
              the OP Docket, telephone 703-305-5805, .or see
              EPA's web site, www.epa.gov/pesticides/op.)
                     EPA is exchanging information with
              stakeholders and the public about the OPs, their
              uses, and risks through Technical Briefings,
              stakeholder meetings, and other fora. USDA is
              coordinating input from growers and other OP
              pesticide users.
                     Based on current information from
              interested stakeholders and the public, EPA is
              making interim risk management decisions for
              individual OP pesticides, and will make final
              decisions once the cumulative risks for all the OPs
              are considered.

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       EPA's next step under FQPA is to consider the cumulative risks and risk management
 decision encompassing all the OP pesticides, which share a common mechanism of toxicity.  The
 interim decision on ethoprop cannot be finalized until the cumulative risks for all the OPs axe
 considered Further risk mitigation may be warranted at that time.

       The ethoprop interim decision was made through the OP pilot public participation
 process, which increases transparency and maximizes stakeholder involvement in EPA's
 development of risk assessments and risk management decisions. EPA worked extensively with
 affected parties to reach the decisions in this interim decision document, which concludes the OP
 pilot process for ethoprop.
 Uses
       An insecticide and nematicide, ethoprop is used to control wireworms and nematodes in
       potatoes, sugar cane, sweet potatoes, and tobacco, with lesser usage on corn (field and
       sweet), beans (lima and snap), cucumbers, and cabbage. In addition, it is used to treat
       pineapples, bananas, and plantains, as well as field-grown ornamentals and non-bearing
       citrus trees.

       According to Agency estimates, annual domestic use was approximately 700,000 pounds
       of active ingredient per year from 1987 through 1996.  Based on usage data from the
       technical registrant for 1998 through 2000, about 1 million pounds of active ingredient
       per year is used nationally. The more recent data indicate that roughly 60% of the
       ethoprop applied is used on potatoes, with sugar cane and sweet potatoes accounting for
       the next higher usages.
Health Effects
       Ethoprop can cause cholinesterase inhibition in humans; that is, it can overstimulate the
       nervous system causing nausea, dizziness, confusion, and at very high exposures (e.g.,
       accidents or major spills), respiratory paralysis and death.
Risks
      Dietary exposures from eating food crops treated with ethoprop is not of concern to the
      Agency for the entire U.S. population or for any population subgroup, including infants

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       and children. Dietary exposure from drinking water is of concern to the Agency, based
       on estimates fiom screening-level modeling for both surface and ground water sources.

       EPA has risk concerns for workers who load and apply ethoprop, both the granular and
       liquid formulations. For the granular formulations, the worker risk concerns are driven
       by the amoimt of dust and the txjtential for inhalation exposure. For the liquid
       formulation, the risk driver is the potential for dermal exposure. To address mis concern,
       the registrant is conducting a worker biomonitoring study to provide highly-refined,
       product-specific data. A reregistration eligibility decision will not be made on the liquid
       formulation until these studies are completed.

       Ethoprop presents risks to non-target terrestrial wildlife species, including birds,
       mammals., and bees. In addition, it presents high risks to aquatic organisms, both fish and
       invertebrates.
Benefits

       The benefits of ethoprop use on potatoes are estimated to be important, especially for the
liquid formulation in areas with low rainfall, due to its availability to be tank-mixed and co-
applied with liquid soil fumigants, and its efficacy to control nematodes and wireworms. There
are benefits for the use of the liquid, as well as granular formulations, for other crops as well,
such as sugar cane, sweet potatoes, bananas, plantains, and pineapples.

Risk Mitigation

Dietary Risk

       No mitigation is necessary at this time for any dietary (food) exposure to ethoprop.  The
acute and chronic dietary (food) risks from ethoprop do not pose concerns to the Agency.

       Drinking water risk assessments are based on screening-level modeling estimates. The
Agency believes actual drinking water exposures are much lower and are not of concern. To
provide actual exposure data to demonstrate that drinking water risks are not of concern, the
registrant will conduct drinking water monitoring of both surface and ground water sources.

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Occupational Risk

       In order to mitigate occupational risks, the following risk mitigation measures arc
necessary:

      treatment of golf courses is being voluntarily cancelled;
      restrict the maximum number of applications for all uses to one application per year,
       except for use on bananas, plantains, and pineapples; and
      reduce the maximum application rates (for tobacco from 12 pounds of active ingredient
       per acre (Ib ai/A) to 6 Ib ai/A, for potatoes to treat nematodes east of the Mississippi
       River from 12 Ib ai/A to 9 Ib ai/A, for ornamentals from 6 Ib ai/A to 3 Ib ai/A, and for
       pineapples from 12 Ib ai/A to 6 Ib ai/A).

       Specifically for the granular formulations, the following worker risk mitigation measures
are necessary:

      the 10G formulation is voluntarily cancelled;
      the 1SG formulation will be manufactured with an inert ingredient having lower dust
       content, to mitigate risks associated wim inhalation exposures;
      the 20G formulation will now specify use only on sugar cane, and will be packaged
       solely in closed transfer containers;
      both of the remaining granular formulations are to be applied to agricultural crops only
       with enclosed cab equipment;
      the following applications will be prohibited:
             all aerial applications;
             slit treatment;
             push-type spreaders;
             applications to peanuts;
             broadcast applications to sweet potatoes; and
             all hand applications, including direct hand-held equipment, such as spoons.

       Although the Agency is not making a reregistration eligibility decision concerning the
liquid formulation at mis time, in the interim, the following risk mitigation measures are
necessary for workers handling the liquid formulation:

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      prohibit applications with: liquid low-pressure handwand sprayers; liquid backpack
      sprayers; liquids with a sprinkler can; mbdngAoading/applying liquid concentrate by a
      handheld measuring container; and hand-dipping of citrus seedlings in liquids;
      prohibit use on: snap beans; lima beans; field corn; sweet corn; peanuts; sugar cane; and
      citrus seedlings; and
      prohibit broadcast applications to cabbage and sweet potatoes.
Ecological Risk
      To mitigate ecological risks, the following mitigation measures are necessary:

      all applications of ethoprop must be incorporated into the soil, either by mechanical
      means immediately after applications with ground equipment, or by water incorporation;
      the liquid formulation label will specify no-spray zone buffer strips for the protection of
      surface waters (including within 140 feet of inland freshwater habitats and along the
      Atlantic seaboard, within 800 feet of brackish water habitats); and
      various risk mitigation measures described above will also address ecological concerns,
      including:
            restricting the maximum number of applications;
            canceling certain uses;
            reducing maximum application rates; and,
            canceling broadcast applications for some uses.
Next Steps
       There is no additional comment period for the ethoprop IRED, which is in its .final form.
       The registrant and stakeholders have commented on the risk assessments and the
       proposed risk mitigation measures. You can find more information about the Agency's
       public participation process for the OPs at www.epa.gov/pesticides/op. For documents
       specific to ethoprop, go to www.epa,gov4>estiddes/reregistration/status.htm.

       EPA will revoke 9 tolerances for ethoprop as part of the IRED. When the cumulative
       risks are considered for the OP pesticides, the Agency will issue its final tolerance
       reassessment decision for ethoprop and may request further risk mitigation measures. At
       that time, EPA will raise and/or establish new tolerances.

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                  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                  WASHINGTON, D.C.  2O46O
                                                                        OFFICE OF
                                                                  PREVENTION, PESTICIDES
                                                                  AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
JUL  0
      This is to inform you that the Environmental Protection Agency (hereafter referred to as
the Agency or EPA) has completed its review of the available data and public comments received
related to the preliminary and revised risk assessments for the organophosphate (OP) pesticide
ethoprop. The public comment period on the revised risk assessment phase of the reregistration
process is closed. Based on comments received during the public comment period and additional
data received from Aventis CropScience, the technical registrant, the Agency revised the risk
assessments, and made the human health and environmental effects risk assessments available to
the public on September 1,1999. Additionally, the Agency held a Technical Briefing on
September 2,1999, during which the results of the revised human health and environmental
effects risk assessments were presented to the general public. This Technical Briefing concluded
Phase 4 of the OP Public Participation Pilot Process developed by the Tolerance Reassessment
Advisory Committee (TRAC), and initiated Phase 5 of that process. During Phase 5, all
interested parties were invited to participate and provide comments and suggestions on ways the
Agency might mitigate the estimated risks presented hi the revised risk assessments. This public
participation and comment period commenced on September 14 1999, and closed on November
12,1999..

      Based on its review, EPA has identified risk mitigation measures that the Agency
believes are necessary to address the human health and environmental risks associated with the
current use of ethoprop, and various types of additional data that are necessary to confirm these
risk mitigation measures. The Agency is now publishing its interim decision on the reregistration
eligibility of and risk management decision for the current uses of ethoprop and its associated
human health and environmental risks. The reregistration eligibility and tolerance reassessment
decisions for ethoprop will be issued once the cumulative risks for all of the OP pesticides are
considered. The Agency may need to pursue further risk management measures for ethoprop
once cumulative risks are considered.  The enclosed "Interim Reregistration Eligibility Decision
for Ethoprop," which was approved on September 28,2001, contains the Agency's decision on
the individual chemical ethoprop.

      A Notice of Availability for this interim reregistration eligibility decision (IRED) for
ethoprop is being published in the Federal Register.  To obtain a copy of the IRED document,
please contact the OPP Public Regulatory Docket (7502C), US EPA, Ariel Rios Building, 1200
Pennsylvania Avenue NW, Washington, DC 20460, telephone (703) 305-5805. Electronic
copies of the IRED and all supporting documents are available on the Internet at
http:www.epa.gov/pesticides/op.

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       The IKED is based on the updated technical information found in the ethoprop Public
 Docket.  This docket not only includes background information and comments on the Agency's
 preliminary risk assessments, it also now includes the Agency's revised risk assessments for
 ethoprop, the revised human health risk assessment as of September 2,1999 (with a revision of
 the worker risk assessment on May 18,2000) and environmental effects risk assessment
 available on October 5,1998 (with various subsequent errata, the most recent on March 26,
 2001), and a document summarizing the Agency's Response to Comments. The Response to
 Comments document addresses corrections to the preliminary risk assessments submitted by
 chemical registrants, and responds to comments submitted by the general public and stakeholders
 during .the comment period on the risk assessment. The docket also includes comments on the
 revised risk assessment, and any risk mitigation proposals submitted during Phase 5. For
 ethoprop, comments and suggestions on mitigation were submitted by Aventis CropScience, the
 U.S. Department of Agriculture, the National Potato Council, the Pineapple Growers Association
 of Hawaii, and the International Banana Association.

       This document and the process used to develop it are the result of a pilot process to
 facilitate greater public involvement and participation in the reregistration and/or tolerance
 reassessment decisions for these pesticides. As part of the Agency's effort to involve the public
 in the implementation of the Food Quality Protection Act of 1996 (FQPA), the Agency is
 undertaking a special effort to maintain open Public Dockets on the OP pesticides and to engage
 the public in the reregistration and tolerance reassessment processes for these chemicals. This
 open process follows the guidance developed by the TRAC, a large multi-stakeholder advisory
 body that advised the Agency on implementing the new provisions  of the FQPA. The
 reregistration and tolerance reassessment reviews for the OP pesticides are following this new
 process.

       Please note that the ethoprop risk assessment and the attached IRED concern only this
 particular OP. This IRED presents the Agency's conclusions on the dietary risks posed by
 exposure to ethoprop alone.  The Agency has also concluded its assessment of the ecological and
 worker risks associated with the use of ethoprop alone. Because the FQPA directs the Agency to
 consider available information on the basis of cumulative risk from substances sharing a
 common mechanism of toxicity,  such as the toxicity expressed by the OPs through a common
 biochemical interaction with choHnesterase enzyme, the Agency will evaluate the cumulative risk
 posed by the entire OP class of chemicals after considering the risk for the individual OPs. The
 Agency is working towards completion of a methodology to assess  cumulative' risk, and the
 individual risk assessments for each OP are likely to be necessary elements of any cumulative
 assessment The Agency has decided to move forward with individual assessments and to
 identify mitigation measures necessary to address those human health and environmental risks
 associated with the current uses of ethoprop. The Agency will issue the final tolerance
 reassessment decision for ethoprop and finalize decisions on reregistration eligibility once the
 cumulative risks for all of the OPs are considered.

      This document contains both a generic and a product-specific Data Call-In (DCI) that
 outline further data requirements for this chemical.  Note that a complete DCI, with all pertinent
 instructions, is being sent to registrants under separate cover. Additionally, the first set of
required responses is due 90 days from the receipt of the DCI letter. For product-specific DCIs,
the second set of required responses is due eight months from the date of the DCI.

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      In this IRED, the Agency has determined that ethoprop will be eligible for interim
reregistration, except for the emulsifiable concentrate formulation, provided mat all the
conditions identified in mis document are satisfied, including implementation of the risk
mitigation measures outlined in Section IV of the document. The Agency believes that current
uses of ethoprop may pose unreasonable adverse effects to human health and the environment,
and that such effects can be mitigated with the risk mitigation measures identified in this IRED.
Accordingly, registrants should implement these risk mitigation measures immediately. The
Agency is not making a reregistration eligibility decision for the emulsifiable concentrate
formulation at this time. Certain conditions stipulated in this IRED document need to be fulfilled
in order for the Agency to make a reregistration eligibility decision for this formulation. Sections
IV and V of this IRED describe labeling amendments for end-use products and data requirements
necessary to implement these mitigation measures. Instructions for registrants on submitting the
revised labeling can be found in the set of instructions for product-specific data that accompanies
this IRED.

       Should a registrant fail to implement any of the risk mitigation measures outlined in mis
document, the Agency will continue to have concerns about the risks posed by ethoprop.  Where
the Agency has identified any unreasonable adverse effect to human health and the environment,
the Agency may at any time initiate appropriate regulatory action to address this concern.  At that
time, any affected person(s) may challenge the Agency's action.

       If you have questions on this document or the label changes necessary for reregistration,
or for questions about the product reregistration and/or the product-specific DCI that
accompanies this document, please contact the SRRD Chemical Review Manager for ethoprop,
Anthony Britten at (703) 308-8179.

                                        Sincerely,
                                        Lois A. Rossi, Director
                                        Special Review and
                                         Reregistration Division
 Attachment

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Interim Reregistration Eligibility Decision
                  for
               Ethoprop


               CASE 0106

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                              TABLE OF CONTENTS

Executive Summary

I. Introduction
II. Chemical Overview ............................. ............................ 6
      A.  Regulatory History .................... ...................  .........    6
      B.  Chemical Identification  ....................  ........................... 6
      C.  Use Profile ....................... . .......     .............  .....     7
      D.  Estimated Usage of Pesticide ............... ..................... ........ ?

HI. Summary of Ethoprop Risk Assessment ........... . ............................ 12
      A.  Human Health Risk Assessment ........ ...... . ......................... 12
             1. Dietary RiskfromFood ............. ........... v  ............. 13
                   a. Toxicity ................... ............................. 13
                   b. Food Quality Protection Act (FQPA) Safety Factor .............. 15
                   c. Population Adjusted Dose (PAD) ............. ............... 16
                   d. Exposure Assumptions .............. ..........  ........... 16
                   e. Food Risk Characterization ................................. 18
             2. Dietary Risk from Drinking Water . ................................ 19
             3. Occupational and Non-Occupational Risk ........................... 22
                   a. Toxicity Profile ........ .......... ........................ 23
                   b. Occupational Exposure .........................   ......... 24
                   c. Occupational Risk Summary ................................ 27
                   d. Post-Application Exposure and Risk ................ ......... 33
                   e. Non-Occupational Exposure and Risk ................... ..... 34
                   f. Incident Reports ................ . ..... .................... 35
             4. Aggregate Risk  ............................... ............. .... 36
       B. Environmental Risk Assessment  ........................................ 37
             1. Environmental Fate and Transport  .................... ............. 37
             2. Ecological Risk Assessment Analysis .............................. 39
                   a. Ecological Hazard Profile .................................. 39
                   b.  Risk to Birds and Mammals ..................... ........... 39
                   c. Risk to Aquatic Species  ............................ ....... 41
                   d  Risks to Endangered Species  ........................... ---- 42

 IV.  Interim Reregistration Eligibility and Risk Management Decisions .................. 44
       A. Determination of Interim. Reregistration Eligibility  ...... ..... . ---- . ........ 44
       B. Summary of Phase 5  Comments and Responses  ............................ 45
       C. Regulatory Position  ......................... ......................... 46
             1. FQPAFindings  .......................... ...................... 46
                    a.  "Risk Cup" Determination  ................................. 46
                    b.  Tolerance Summary . . .................... ................ 46
             2. Endocrine Disrupter Effects .......... . ............... ............ 51

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       D. Regulatory Rationale	52
             1.  Human Health Risk Mitigation	.. 52
                   a. Dietary Mitigation	52
                          i) Acute Dietary (Food)	52
                          ii) Chronic (Non-Cancer) Dietary (Food)	52
                          iii) Cancer Dietary (Food)	52
                          iv) Drinking Water	52
                   b. Occupational Risk Mitigation	58
                          i) Agricultural Uses	58
                          ii) Golf Course Uses	67
                   c. Non-Occupational Risk Mitigation	67
             2.  Environmental Risk Mitigation	67
                   a. Nontarget Terrestrial Organisms	67
                   b. Nontarget Aquatic Organisms	69
       E.  Labeling	 71
             1.  Endangered Species Statement	72
             2.  Spray Drift Management	,	73

V. What Registrants Need to Do	75
       A.  Manufacturing-Use Products	76
             1.  Additional Generic Data Requirements 	76
             2.  Labeling for Manufacturing-Use Products	78
       B.  End-Use Products	.78
             1.  Additional Product-Specific Data Requirements	78
             2.  Labeling for End-Use Products	78
       C.  Existing Stocks	78
       D.  Labeling Changes Summary Table	79

VI. APPENDICES 	92
       Appendix A.  Table of Use Patterns Eligible for Reregistration for Ethoprop	93
       Appendix B.  Generic Data Requirements and Studies Utilized to Make the ERED for
                   Ethoprop	98
       Appendix C.  Technical Support Documents Utilized to Make the ERED for Ethoprop
                    	 105
       Appendix D.  Citations Supporting the IRED for Ethoprop (Bibliography)	108
       Appendix E.  Generic Data Call-In	. 132
       Appendix F.  Product Specific Data Call-In	139
       Appendix G.  Batching of Ethoprop Products for Meeting Acute Toxicity Data
                   Requirements for Reregistration	145
       Appendix H.  List of Registrants Sent this Data Call-In	 147
       Appendix I.  List of Available Related Documents and Electronically Available Forms
                    	149

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ETHOPROP TEAM

Office of Pesticide Programs:

Health Effects Risk Assessment

KitFarwell
Catherine Bodurow Joseph
Jeffrey Dawson
Sheila Piper
Christina Swartz
Michael Metzger

Environmental Fate. Drinking Water, and Ecological Risk Assessment

Sid Abel
Jim Cowles
Nicholas E. Federoff
Jean Holmes
Dana  Spate
Ann Stavola
Mah Shamim
Dirk Young

Use and Usage Analysis

John Faulkner
William Gross

Registration Support

Marilyn Mautz

Risk Management

Bentley C. Gregg
Michael Goodis

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                     GLOSSARY OF TERMS AND ABBREVIATIONS
ai              Active Ingredient
aPAD          Acute Population Adjusted Dose
ARC           Anticipated Residue Contribution
[14C]           Radio-labeled Carbon Atom
CAS           Chemical Abstracts Service
ChE           Cholmesterase, an enzyme of the nervous system
cPAD          Chronic Population Adjusted Dose
CSF           Confidential Statement of Formula
CFR           Code of Federal Regulations
DCI           Data Call-in
DEEM         Dietary Exposure Evaluation Model
DWEC         Drinking Water Estimated Concentration
DWLOC       Drinking Water Level of Comparison
EC            Emulsifiable Concentrate
EEC           Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
               such as a terrestrial ecosystem.
EFED          Environmental Fate and Effects Division
EP            End-Use Product
EPA           U.S. Environmental Protection Agency
FDA           Food and Drug Administration
FFDCA        Federal Food, Drug, and Cosmetic Act
FIFRA         Federal Insecticide, Fungicide, and Rodenticide Act
FQPA          Food Quality Protection Act
FR            Federal Register
FRSTR        Final Registration Standard and Tolerance Reassessment
FWS           United States Fish and Wildlife Service
G             Granular Formulation
GC/FPD       Gas Chromatography/Flaine Phosphorus Detector
GLC           Gas Liquid Chromatography
GLN           Guideline Number
IR            Index Reservoir
RED          Interim Reregistration Eligibility Decision
LCj0           Median Lethal Concentration. A statistically derived concentration of a substance that can be
               expected to cause death hi 50% of test animals. It is usually expressed as the weight of substance
               per weight or volume of water, ah- or feed, e.g., mg/1, mg/kg or ppm.
               Median Lethal Dose.  A statistically derived single dose mat can be expected to cause death hi
               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.
LOAEL        Lowest Observed Adverse Effect Level
LOG           Level of Concern
LOD           Limit of Detection
LOQ           Limit of Quantitation
ug/g.          Micrograms Per Gram
ug/L           Micrbgrams Per Liter
mg/kg/day      Milligrams per Kilogram Body Weight per Day
mg/L          Milligrams Per Liter
MOE          Margin of Exposure
MUP          Manufacturing-Use Product
MRID         Master Record Identification (number). The Agency's system of recording and tracking the studies
               submitted.
N/A           Not Applicable
NAFTA       North American Free Trade Agreement
NAWQA       USGS National Water Quality Assessment
ND           No Data available
NOAEL       No Observable Adverse Effect Level
LD
  '50

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NOEC         No Observable Effect Concentration
NPTN         National Pesticide Telecommunications Network
OP            Organophosphale
OPP           Office of Pesticide Programs
ORETF        Outdoor Residential Exposure Task Force
Pa            Pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
PAD           Population Adjusted Dose
PAM          Pesticide Analytical Method
PCA           Percent Cropped Area
PDCI,         Product-Specific Data Call-in
PDP           USDA Pesticide Data Program
PF            Protection Factor
PHED         Pesticide Handlers Exposure Database
PHI           Preharvest Interval
ppb           Parts Per Billion
PPE           Personal Protective Equipment
ppm           Parts Per Million
PRN           Pesticide Registration Notice
PRZM/EXAMS Tier II Surface Water Computer Model (Pesticide Root Zone Model/Exposure Analysis Modeling
             '  System)
Qi*           The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model (also
               known as the cancer slope factor)
QUA          Quantitative Usage Analysis
RAC           Raw Agricultural Commodity
RBC           Red Blood Cell
RED           Reregistration Eligibility Decision
REI           Restricted Entry Interval
RfD           Reference Dose
PPM           Reasonable and Prudent Measures
RQ            Risk Quotient, used in the ecological risk assessment to estimate the potential risk to nontarget
               organisms
RS            Registration Standard
RUP           Restricted Use Pesticide
SCI-GROW    Tier I Ground Water Computer Model (Screening Ground Water)
SF            Safety Factor
SFWMD       South Florida Water Management District
SLN           Special Local Need  (Registrations Under Section 24 (c) of FIFRA)
TGAI          Technical Grade Active Ingredient
torr            A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
TRAC         Tolerance Reassessment Advisory Committee
UF            Uncertainty Factor
USDA         United States Department of Agriculture
USGS          United States Geological Survey
UV            Ultraviolet
WPS           Worker Protection Standard

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Executive Summary

       EPA has completed its review of public comments on the revised risk assessments and is
issuing its interim reregistration eligibility decision (IRED) for the active ingredient ethoprop.
The decisions outlined in this document do not include the final tolerance reassessment decision
for ethoprop; however, some tolerance actions will be undertaken prior to completion of the final
tolerance reassessment. A total of 24 tolerances are reassessed as part of the ethoprop IRED.  Of
these, nine tolerances will be revoked; twelve will remain unchanged; two new tolerances for  .
corn are to be listed, as a result of correcting commodity definitions; and one tolerance for snap
beans is to increase. However, the final tolerance reassessment decision for this chemical,
including any increase and establishment of new tolerances, will be deferred until after
cumulative risks for all the organophosphate (OP) chemicals are considered, as required by
FQPA. Note that the Agency may need to pursue further risk management measures for ethoprop
once cumulative risks are considered.

       The revised risk assessments are based on review of the required data supporting the use
patterns of currently registered products and new information received in response to the
preliminary risk assessment. The Agency invited stakeholders to provide proposals, ideas or
suggestions on appropriate mitigation measures before the Agency issued its IRED on ethoprop.
After considering the revised risks, as well as comments and mitigation measures proposed by
Aventis CropScience, the technical registrant of ethoprop; various growers groups and
agricultural extension agents, including the National Potato Council; and other interested parties,
EPA developed its interim risk management decision for uses of ethoprop that pose risks of
concern. This decision is summarized in the discussion that follows.

Use and Usage Summary

       Ethoprop is an OP insecticide and nematicide, first registered in 1967, used on
agricultural crops, field-grown ornamentals, and golf course turf. With the exception of
pineapples, bananas, plantains, potatoes, peanuts, and corn, it is  applied pre-plant or at-plant.
Most of ethoprop is formulated as either a granular product or an emulsifiable concentrate
(liquid) product. Usage data from 1987 to 1996 indicated an average domestic use of
approximately 700,000 Ib active ingredient (ai) per year, while more recent data provided by the
technical registrant indicated that domestic use in 1998 to 2000 was about 1 million Ib ai per
year.

Dietary Risks

       The subpopulation with the highest exposure (infants < 1 year old) has an estimated
ethoprop exposure of 75% of the acute  population adjusted dose, so acute dietary (food) exposure
for ethoprop is not of concern to the Agency. The population subgroup with the highest chronic
exposure (children 1-6 years old) has an estimated ethoprop exposure of 1.2% of the chronic
population adjusted dose, so chronic (food) dietary exposure is not of concern to the Agency.
The estimated chronic carcinogenic dietary risk for ethoprop is 1.1 x 10"8, which is below 1 x 10"6
and not of concern to the Agency.  Therefore, no mitigation is warranted at this time for any
dietary (food) exposures to ethoprop.

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       The acute drinking water level of comparison (DWLOC) is 0.6 ppb, and the DWLOCs
 for chronic and cancer exposures are 1.0 ppb, which are much lower than the drinking water
 estimated concentrations (DWECs). Based on screening level models, the highest DWEC for
 acute surface water concentrations is 127 ppb, and the highest chronic and cancer DWECs for
 surface water concentrations are 25 ppb and 13 ppb, respectively. For ground water, the highest
 estimated concentration was 10.1 ppb.  Thus, the DWECs for surface and ground water exceed
 the Agency's respective DWLOCs.  To address both surface and ground water risk concerns, the
 technical registrant is to conduct monitoring programs in high usage areas with vulnerable soil
 conditions. The Agency expects the actual measured surface and ground water concentrations to
 be less than the DWLOCs. However, if the results of either monitoring program indicate a
 potential unacceptable drinking water risk level, the technical registrant has agreed to drop select
 uses from the technical and product labels until risk concerns are fully addressed.

 Golf Course Use Risks

       The post-application exposure assessment was conducted for turf management workers.
 When using both tractors and push-type mowers, risk assessments determined that restricted
 entry intervals (REIs) greater than 10 days were  required before workers could re-enter treated
 areas for activities, such as mowing. An assessment to quantify golfer risk following ethoprop
 treatment was also conducted, and indicated that more than 10 days were required before golfers
 could enter areas that have been treated to play golf. Based on these risks to workers and golfers,
 and other risk concerns, all golf course turf uses  for ethoprop have been voluntarily cancelled.

 Aggregate Risks

       For ethoprop, aggregate risk calculations are based on acute and chronic exposure from
 only food and drinking water sources, because ethoprop use on golf courses has been voluntarily
 cancelled and non-occupational or recreational (golfer) exposures need not be combined with
 dietary sources. As discussed above, the DWECs for surface water and ground water exceed the
 calculated DWLOCs, so the Agency has risk concerns. Because the drinking water risks, are
 based on modeling estimates for both surface water and ground water, the technical registrant has
 agreed to conduct water monitoring to further refine these drinking water exposures for both
 surface and ground water sources to demonstrate that drinking water risks are not of concern.
 Again, the Agency expects the actual measured surface and ground water concentrations to be
 less than the DWLOCs and not of concern.

 Occupational Risks

      At the maximum label application rates, all of the handler exposure scenarios exhibited
risks of concern to the Agency, even when utilizing engineering controls. The risk driver for
granular products is the inhalation route of exposure, because the products are formulated with
dusty clay-type material, and the risk driver for the emulsifiable concentrate (EC) product is the
dermal route of exposure. To help mitigate these risks, the registrant has agreed for most
granular products to substitute the clay with less dusty material, such as Biodac. The registrant
has submitted data which demonstrates that this material will reduce the level of dust to which
workers could be exposed during normal handler activities. Based on this and other information,

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the Agency believes that the risks associated with the use of the granular formulation are below
their respective targets and not of concern, and are requiring confirmatory data to support this
conclusion.  The product that will remain formulated with clay material is less dusty than the
other granular formulations, and the technical registrant has agreed to manufacture this
formulation solely in closed transfer packaging.

       To help reduce worker risks for the EC formulation, the registrant has agreed to amend
the labels of these products to specify the use of engineering controls, including bom the use of
closed loading and mixing systems, and the use of enclosed cabs. Because further measures are
needed to mitigate risk concerns, the registrant has initiated a biomonitoring study to demonstrate
actual exposure to workers that mix/load and apply the ethoprop EC product are lower than
indicated by the risk assessment and are not of concern. The study results are to be submitted to
the Agency by March 31,2002.  The registrant has also agreed that if results of the biomonitoring
study and supporting pharmacokinetics data do not demonstrate acceptable risks to workers with
the EC formulation, the registrant will voluntarily cancel their registration of the EC formulation.
Because the current worker risks presently assessed are extremely high and of concern to the
Agency, the decision of reregistration eligibility of the EC formulation is deferred pending the
results of the required biomonitoring study and other supporting data.

       For ethoprop, cancer risks for workers are generally not of concern to the Agency, but
some scenarios are of concern for both types of formulations.  The Agency anticipates that the
risk mitigation measures for the granular and EC formulations will reduce the risks for ethoprop,
such that cancer risks will no longer be of concern.

Ecological Risks

       The ecological risk assessment indicates that the Agency has risk concerns for birds,
mammals, fish, and invertebrates. Reasons for these risk concerns include the moderate to highly
toxic characteristics of ethoprop in testing with these groups of animals, as well as the exposure
concentrations due to its moderate mobility in soils and its potential for runoff. To mitigate these
ecological risk concerns, various measures are to be implemented, including soil incorporation,
dropping certain uses, reducing maximum application rates, deleting broadcast applications for
some uses, limiting the number of applications, and imposing buffer zones for the EC
formulation. In addition, the Agency recognizes that there are substantial and unique benefits
associated with the use of ethoprop, due to its effectiveness against various pests and its cost-
competitiveness in comparison with some less efficacious alternative chemicals.

Label Changes Summary

       The following is a summary of the changes to technical and product labels that are
necessary to mitigate the risks discussed above. The technical registrant has agreed to cancel the
following uses:
            peanuts;
            citrus seedlings; and
            golf courses.

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       The technical registrant has agreed to cancel the following use methods:
             all aerial applications;
             slit treatment;
             push-type spreaders;
             hand applications, including direct hand-held equipment, such as spoons;
       0      liquid low-pressure handwand sprayers;
             liquid backpack sprayers;
             liquids with a sprinkler can;
             mixing/loading/applying liquid concentrate by a handheld measuring container;
             and
       8      hand-dipping in liquids.

       The technical registrant has agreed to modify the following use practices:
       o      delete post-plant treatments to com;
       o      delete broadcast applications of the EC to cabbage; only banded treatments are
             permitted;
       o      delete broadcast applications to sweet potatoes; only banded treatments are
             permitted for both the EC and granular formulations;
             drop the following crops from the current EC label: snap and lima beans, field
             and sweet corn, and sugar cane;
             restrict the maximum number of applications for all uses to one application per
             year, except for use on bananas, plantains, and pineapples;
             reduce the maximum label rate for tobacco from 12 Ib ai/A to 6 Ib ai/A;
             reduce the maximum label rate for potatoes to treat nematodes east of the
             Mississippi River from 12 Ib ai/A to 9 Ib ai/A;
             reduce the maximum label rate for ornamentals from 6 Ib ai/A to 3 Ib ai/A;
             reduce the maximum label rate for granular treatments to pineapples (Special
             Local Needs label) from 12 Ib ai/A to 6 Ib ai/A; and
       *      specify immediate soil incorporation by mechanical equipment for all products as
             they are being applied by ground equipment, or that watering-in is to be conducted
             immediately following applications (for chemigation methods and for use on
             bananas, plantains., and pineapples only).

       The Agency is issuing this IRED for ethoprop, as announced hi a Notice of Availability
published in the Federal Register.  This IRED document includes guidance and time frames for
adopting any necessary label changes for products containing ethoprop. Note that there is no
comment period for this document.

       This document consists of six sections: Section I introduces the regulatory framework for
reregistration and tolerance reassessment Section n is a chemical overview which includes a use
profile of ethoprop.  Section m summarizes the revised human health and ecological risk
assessments. Section IV discusses the Agency's IRED and risk management approach for
ethoprop and summarizes the Agency's response to public comment. Section V identifies what
registrants need to do, including data and label changes required to reregister ethoprop products
based on the Agency's risk mitigation decisions. Section VI contains Appendices, such as the
data call-in (DCI), a list of the documents supporting this IRED and how to access them
(including the full revised risk assessments), and "batching" information.

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L  Introduction

       The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregistration of products with active ingredients registered prior to November 1,
1984. The amended act calls for the development and submission of data to support the
reregistration of an active ingredient, as well as a review of all submitted data by the U.S.
Environmental Protection Agency (EPA, or "me Agency") to determine whether a pesticide
containing such active ingredient is eligible for reregistration.  Thus, reregistration involves a
thorough review of the scientific database underlying a pesticide's registration. The purpose of
the Agency's review is to reassess the potential hazards arising from the currently registered uses
of the pesticide; to determine the need for additional data on health and environmental effects;
and to determine whether the pesticide meets me "no unreasonable adverse effects" criterion of
FIFRA.

       On August 3,1996, the Food Quality Protection Act of 1996 (FQPA)  was signed into
law. This Act amends FIFRA to require tolerance reassessment during reregistration.  It also
requires that by 2006, EPA must review all tolerances in effect on the day before the date of the
enactment of the FQPA. FQPA also amends the FFDCA to require a safety finding in tolerance
reassessment based on factors including an assessment of cumulative effects of chemicals with a
common mechanism of toxicity. Although FQPA significantly affects the Agency's
reregistration process, it does not amend any of the existing reregistration deadlines. Therefore,
me Agency is continuing its reregistration program while it resolves me remaining issues
associated with the implementation of FQPA.

       This document presents the Agency's revised human health and ecological risk
assessments; its progress towards tolerance reassessment, including a determination of safety of
existing tolerances; and the interim reregistration eligibility decision (TRED)  for ethoprop. It is
only one of several steps in the reregistration process for. ethoprop. The Agency will proceed
with its assessment of the cumulative risk of the organophosphate (OP) pesticides and issue a
final reregistration eligibility decision for ethoprop.

       The Agency published Pesticide Registration (PR) Notice 2000-9, Worker Risk
Mitigation for Organophosphate Pesticides, in the Federal Register (September 29,2000),
which presents EPA's proposed approach for managing risks from OP pesticides to occupational
users.  This notice describes the Agency's baseline approach to managing risks to handlers and
workers of OP pesticides. Generally, basic protective measures (such as closed mixing and
loading systems, enclosed cab equipment, or protective clothing), as well as increased restricted
entry intervals, will be necessary for most uses where current risk assessments indicate risks that
are of concern to the Agency, and where such protective measures are feasible. PR Notice 2000-
9 also states that the Agency will assess each OP pesticide individually, and based upon the risk
assessment, determine the need for specific measures tailored to the potential risks of the
chemical. The measures included in this IRED are consistent with that PR Notice.

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IL Chemical Overview

      A. Regulatory History

      Ethoprop was first registered in the United States in 1967 to Mobil Oil Corporation, and
was transferred to Rhone-Poulenc Ag Company in 1981. In January 2000, Rhone-Poulenc
merged with Hoechst Corporation (and its U.S. subsidiary, AgrEvo); the name of the registrant
for technical ethoprop is now Aventis CropScience. Ethoprop is used as an insecticide and
nematicide.  Ethoprop is a List A reregistration chemical, and was the subject of a Registration
Standard (February 28,1983), a Final Registration Standard and Tolerance Reassessment
(FRSTR; November 20,1987), and their respective Guidance Documents (May 1983 and May
1988). These documents summarized regulatory conclusions on the available data, and specified
the, additional data that were required for reregistration purposes. Numerous submissions of data
have been received since the FRSTR was issued.

      B. Chemical Identification

      ETHOPROP:
                  Common Name:.

                  Chemical Name:

                  Chemical Family:

                  Case Number

                  CAS Registry Number:

                  OFF Chemical Code:

                  Empirical Formula:

                  Molecular Weight: -
Ethoprop

O-ethyl-S,S-dipropylphosphorodithioate

Organophosphate

106

13194-48-4

041101

C8H1902PS2

242.3
                   Trade and Other Names:   MOCAP

                   Basic Manufacturer:       Aventis CropScience

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       Technical ethoprop (O-emyl-S,S-dipropylphosphorodithioate) is a colorless to yellow
tinted liquid, with a strong meicaptan odor, and has a boiling point of 86-91 C at 0.2 mm Hg.
Ethoprop is moderately soluble in water (843 ppm at 21C), and is soluble in most organic
solvents (hexane, xylene, acetone, and ethanol).  The vapor pressure of ethoprop is 3.5 x 10"4 mm
Hgat26C.

       C. Use Profile

       The following information is based on the currently registered uses of ethoprop.

       Type of Pesticide:   Insecticide/nematicide

       Summary of Use Sites:

       Food:               Bananas/plantains, beans (dry, snap, and lima), cabbage, com
                           (sweet and field), cucumber, peanuts, pineapple, sugarcane, sweet
                           potato, and white potato. ,
       Residential:

       Public Health:

       Other Nonfood:


       Target Pests:
No residential uses.

No public health uses.

Citrus (non-bearing) and tobacco, as well as field-grown
ornamentals and golf course turf.

Ethoprop is used for the control of wire worms and nematodes,
which live below the soil surface.
       Formulation Types Registered:
                           Aventis CropScience has registrations for technical grades (95.9%
                           and 94.4% active ingredient (ai)), emulsifiable concentrates (EC)
                           (one product is solely ethoprop at 69.6% ai and the other is 46%
                           ethoprop and 23% disulfoton), granulars (3% [one product, which
                           is a multiple ai with 10% pentachloronitrbbenzene (PCNB)], 10%
                           [one product is solely ethoprop and other products are multiple ai,
                           one with 8.8% phorate and the other 5.6% disulfoton], 15%, and
                           20% ai), and a gel in water-soluble packaging (68.2% ai).  Micro-
                           Flo Co. has a registration for a granular (3% ai as a multiple ai with
                           10% PCNB).  Note that Aventis has indicated that their gel
                           formulation and multiple ai products (with disulfoton, phorate, and
                           PCNB) are not currently marketed, and has requested voluntary
                           cancellation of these products.

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Method and Rates of Application:
Equipment -
Method -
Rate-
The current labels for ethoprop indicate that the products may be
applied by aircraft (granulars to potatoes only), chemigation (i.e.,
drip irrigation and sprinkler irrigation), granule applicator (i.e..,
tractor-drawn mechanical spreader and push-type spreader), ground
sprayer equipment, backpack-sprayer, hand-held shaker can, hand-
dipping of citrus seedlings, and to golf course fairways and roughs
by slit treatment (thatch mechanically lifted, and granular product
placed below thatch, which is then returned to the surface of the
ground).

The insecticidal/nematicidal activity of ethoprop is highly
dependent upon incorporating the product into the soil
(mechanically or with water) soon after application to be effective,
especially for those nematodes and insects which live deep in the
soil (some labels specify it is necessary to incorporate at depths up
to 6 inches below the soil surface to insure efficacious activity   
against nematodes and wireworms). Ethoprop is applied to most
crops pre-plant or pre-emergent, but it can also be applied to
plants, as follows: pineapple plants as a chemigation treatment (the
EC label specifies application by drip irrigation be either in tubing
under plastic or buried in the soil 2 to 4 inches deep); pineapple
plants as a soil treatment (only granular formulations); banana and
plantain plants as soil-directed liquid spray or granular broadcast
(backpack spreader or by hand) around the stems of the plants up
to 2 times per year; com at cultivation after plant emergence until
layby (i.e., the last time the corn plants are cultivated); and peanut
plants at pegging (i.e., when the aerial shoots begin to grow into
the ground, prior to maturation of the fruiting bodies). In addition,
potatoes may be treated prior to crop  emergence, and the single-ai
granular ethoprop product labels specify there may be aerial
application to potatoes.

For soil treatments of field crops, the maximum label rates range
from 2 Ib active ingredient per acre (ai/acre) on cucumbers to 12 Ib
ai/A on tobacco and potatoes for agricultural crops, and 20 Ib ai/A
on golf course turf (on current ethoprop labels; however, the
registrant has voluntarily cancelled all golf course uses). The
majority of ethoprop applications are to potatoes in the Pacific
Northwest (PNW), where growers apply either granular or EC
formulation at two application rates: 12 Ib ai/A for control of
nematodes, and 6 Ib ai/A for control of wireworms. For bananas,
the EC label states "apply 8 mL of MOCAP EC in a radius of 3/4
meter around each producing stem," and the 10G and 15G granular
labels similarly list rates to be applied per producing stem (at
                                    8

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       Timing -
       Use Classification:
product rates which are equivalent to 6 grams or 0.2 ounces of
ethoprop active ingredient per plant). For pineapples, both the EC
and gel labels specify that multiple applications are permitted, but
not more than 8 gallons of MOCAP per acre per year for plant
crops, or not more than 5 gallons of MOCAP per acre per year
for ratoon crops.

For field crops, applications must be pre-plant or at-plant and
usually occur in the spring, before the growing season, with only
one application per crop: exceptions for field crops include
treatment of potatoes until crop emergence, corn until at-layby, and
peanuts until at-pegging. For some ratoon row crops, such as sugar
cane, applications may occur only at the time of planting, and the
crop grows for 3 to 5 years before a new crop is replanted.
Applications to banana plants may be up to two times per year.
Concerning applications to pineapples (a crop not on any granular
labels), both the current EC and gel labels specify not more than 8
applications per year for plant crops, or not more than 5
applications per year for ratoon crops, with the timing of these
multiple applications to pineapples specified as "about every two
months." The timing of applications to pineapples relative to the
pre-harvest interval (PHI) on the current EC and gel labels state
"Do not treat within 120 days of harvest of either plant crop or
ratoon crop."

Ethoprop is a restricted use chemical for most products containing
10% or more of the active ingredient, due to acute dermal toxiciry.
       D. Estimated Usage of Pesticide

       This section summarizes the best available estimates for many of the pesticide uses of
ethoprop, based on pesticide usage information for 1987 through 1996. A full listing of all uses
of ethoprop, with the corresponding use and usage data for each site, has been completed and is
in the Quantitative Usage Analysis (QUA) document (February 2,1999, as amended), which is
available in the Public Docket, and the Internet (www.epa.gov/pesticides/op). The QUA
document also lists estimates for the total acres grown to each crop, the weighted average and the
estimated maximum for the acres treated, the average application rates (specifically the Ib ai/A,
the numbers of applications per year, and the Ib ai/A/application), and indicates those states with
the most ethoprop usage for each site (agricultural crop).

       Table 1 summarizes some of the key data from the Agency QUA. The data utilized by
the Agency to compile the QUA, reported on an aggregate and site (crop) basis, reflect annual
fluctuations in use patterns, and include data from various information sources. The sources of
data and information for compiling the QUA are from the Agency (1987-96), United States
Department of Agriculture (USD A; 1990-96), National Center for Food & Agricultural Policy

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(1992), and Market Asia Agricultural Information (1997). According to the QUA, approximately
700,000 Ib ai was applied to treat a little more than 200,000 acres. The usage is presented as a
weighted average estimate for 1987 through 1996, with the most recent years being weighted
more heavily.

       According to information presented in the QUA document, the largest U.S. markets of
ethoprop, in terms of the total pounds active ingredient (Ib ai) sold, are potatoes (35%),
sugarcane (28%), and tobacco (14%). Most of the usage is in the Northwest and South, with
some in the Midwest The crops with the highest percentages of the weighted average for crop
treated are sugarcane and bananas, with approximately 7% and 6%, respectively.

       In general, there is little information available on trends for use of ethoprop on various
crops, except for potatoes.  The Agency QUA (Table 1) estimated that, for the period from 1987
through 1996, about 35% of the ethoprop applied in the United States was used to treat potatoes.
The National Potato Council (NPC) provided information (letter to the Agency dated November
12,1999) which indicated that in 1995, about 20% of the potato crop grown in the Pacific
Northwest (PNW) was treated with ethoprop; however, due to the cancellation of fonofos, use of
ethoprop was expected to increase, with the NPC estimating that 30-40% of the potato crop
grown in the PNW would be treated with ethoprop. While the Agency QUA estimated that about
700,000 pounds of active ingredient were sold annually during the 1987 to 1996 time period,
Aventis has provided data mat indicates that between 1998 and 2000, about 1,000,000 pounds of
active ingredient were sold annually in the United States. While the Agency QUA (Table 1)
indicates that from 1987 to 1996, about 35% of the usage was on potatoes, the Aventis-supplied
data indicates that for 1998 through 2000, as much as 60% of the total ethoprop active ingredient
applied in the United States was used to treat potatoes.

Table 1. Estimated Quantitative Usage Analysis of Ethoprop for Representative Sites
Site
Field Crops:
Beans, Dry
Beans, Green
Corn (field)
Peanuts
Sugarcane
Tobacco
Total Field Crops:
Fruits:
Bananas2
Citrus seedlings
Pineapples 4
Plantains
% of Crop Treated
Weighted Average !

<0.05%
1.4%
<0.05%
0.4%
7.0%
3.2%


6.4%

1.0%
-
Estimated Maximum

0.1%
2.8%
0.1%
1.6%
15.3%
4.3%


16.0%
_
5.0%
.
Pounds of Active
Ingredient Applied
Weighted Average

1,000
15,000
20,000
10,000
200,000
100,000
346,000

_ 3
.
_
-
                                         10

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Site
Vegetables:
Cabbage
Cucumbers
Potatoes, white
Sweet Potatoes
Sweet Corn
Total Vegetables:
Turf & Ornamentals:
TOTAL
% of Crop Treated
Weighted Average *

0.7%
1.0%
2.8%
4.1%
3.8%

.

Estimated Maximum

2.9%
2.1%
5.3%
8.2%
8.9%

.

Pounds of Active
Ingredient Applied
Weighted Average

1,000
3,000
250,000
40,000
30,000
324,000
21,000
691,000
  Based on data for 1987-1996, with the most recent years and the more reliable data weighted more heavily.
2 The estimates of the percent crop treated for bananas are based on an average of the percent of the banana crop
treated in six Latin American countries, and weighted based on me quantity imported into the U.S. for each
producing country.
3 A dash (-) indicates information is not available in Agency sources or is insufficient for purposes of making
estimates.
4 The estimates for the percent crop treated for pineapples are based on an average of the percent of crop treated for
pineapples in two foreign countries, and weighted based on the quantity of U.S. imports, as well as the estimate of
the minimal historical United States production in Hawaii.
                                                    11

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     Summary of Ethoprop Risk Assessment

       The following is a summary of EPA's revised human health and ecological risk findings
and conclusions for the organophosphate pesticide ethoprop, based on the human health
information fully presented in the following documents:
      Ethoprop Revised Human Health Bisk Assessment, September 2,1999;
*    .  Ethoprop: Revised Occupational/Non-Occupational/Residential Exposure Assessment
       For Registration Eligibility Decision (RED) Document, May 18,2000;
      Ethoprop - Review ofaldicarb (Temik 10G) granular backpack mixer/loader/applicator
       study (MRID 451672-01) in bananas as a source of surrogate data for ethoprop exposure
       and assessment, October 17,2000; and
      Ethoprop - Review offlpronil granular mixer/loader/applicator study (MRID 452501-01)
       in bananas as a source of surrogate data and accompanying ethoprop risk assessment,
       January 5,2001.

       The environmental and ecological risk findings are based on the information fully
presented in the following documents:
      Environmental Fate and Effects Division RED Chapter for Ethoprop, October 5,1998;
       and
      addenda dated November 18,1998; February 18,1999; August 30,1999; and April 24,
       2000.
      Revised ethoprop drinking water assessment, March 26,2001

       These documents may also be found on the Agency's web pages
(www.epa.gov/pesticides/opX The purpose of this summary is to assist the reader by identifying
the key features and findings of these human health and ecological risk assessments that provide
the basis for the registration decision presented in this document.

       These risk assessments were presented at the Ethoprop Technical Briefing on September
2,1999, which was followed by an opportunity for public comment on risk management for this
pesticide (Phase 5 of the TRAC process). The risk assessments presented here form the basis of
the Agency's interim risk management decision for ethoprop only; the Agency must consider the
cumulative risks of all the organophosphate pesticides before tolerances are reassessed in
accordance with FQPA.

       A.  Human Health Risk Assessment.

       EPA issued its preliminary human health risk assessments for ethoprop in May of 1998.
In response to comments submitted by the registrant, the public, and USD A, the risk assessments
were updated in September of 1999, and updated again to include additional data submitted by
the registrant. Major refinements of the human health risk assessment are listed below:

           . The revised risk assessments for the granular products incorporate the results of a
             new 28-day dermal toxicity study in the rat with a granular formulation.
                                         12

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       -     The revised worker risk assessments for the granular products also incorporate the
             results of a new worker exposure study with passive dosimetry methods during
             separate and combined loading/application activities with a granular formulation
             using both typical open-pour boxes and closed loading systems.

            The revised risk assessments for golf course workers (loaders/applicators and turf
             management professionals) incorporate data reported in an Outdoor Residential
             Exposure Task Force (ORETF) study in which chemicals were applied by
             granular mixer/loader/applicators using push spreaders to treat golf courses.

       -     The revised risk assessments for golf course workers and golfers (non-
             occupational exposures) incorporate data reported in another Outdoor Residential
             Exposure Task Force (ORETF) study in which turf transferability rates for
             ethoprop were estimated based on data for similar chemicals obtained with
             various sampling methods, active ingredients, and formulations.

       -     The revised risk assessment for workers treating bananas incorporates the results
             from two studies with other chemicals (Temik [aldicarb] and Regent [fipronil]), in
             which workers were loading and applying granular products to bananas with two
             different types of backpack granular spreaders, as well as from the fipronil study,
             utilizing a spoon to apply a granular product to assess hand-application exposures.

            The revised dietary risk assessments incorporate the results for the Agency's new
             Standard Reservoir Index with the percent cropped area (PCA) treated factor, in
             addition to the previously used PRZM model coupled to the EXAMS model, for
             use in developing the Tier II drinking water estimated concentrations for surface
             water for ethoprop.

       As a result of comments from USD A and the registrant concerning the dietary risk
assessment, the Agency decided not to include the Metabolite IV (known as Ml) in calculation of
anticipated residues or as a metabolite of concern for the non-cancer risk assessments, although
the Agency determined that Ml is a metabolite of concern in cancer risk assessments. (The
decision to not include Ml in the calculation of anticipated residues and non-cancer risk
assessments has been supported by a toxicity study for this metabolite, submitted by the
registrant in December 1999. Data from that study indicated that Ml is not as toxic as the parent
ethoprop or some of the other metabolites, since Ml was reported as not being a significant
cholinesterase inhibitor in the rat).

             1. Dietary Risk from Food

                    a. Toxicity

       The Agency has reviewed all toxicity studies submitted for ethoprop and has determined
that the available toxicity studies are satisfactory to support an IRED for all currently registered
ethoprop uses. In discussing the dietary risk assessment for ethoprop, it is of background interest
to characterize the acute oral toxicity; ethoprop is  classified in Toxicity Category I for acute oral
                                          13

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toxicity, based on LDjo values to male and female rats of 61.0 mg/kg and 32.8 mg/kg,
respectively. Details concerning the toxicity of ethoprop can be found in the 1999 Ethoprop
Revised Human Health Risk Assessment, which is available in the Public Docket and may also be
found on the Agency's web page (www.epa.gov/pesticides/op). (Additional types of acute
toxicity data for ethoprop are discussed later in this IRED document in Section LTLA.3.
Occupational and Non-Occupational Exposure.)

       In the subchronic and chronic studies with ethoprop, the main toxic effects seen were
decreased cholinesterase activity, cholinergic signs, anemia, and weight loss. Mild liver toxicity
also occurred in the chronic dog study. The dose-response curve for ethoprop is steep in acute,
subchronic, and chronic studies (e.g., in a combined chronic feeding toxicity and carcinogenicity
study in the rat, mortality occurred at doses only slightly higher than those causing clinical signs).

       The Agency has classified ethoprop as a "likely" human carcinogen, due to the
occurrence of malignant adrenal pheochromocytomas in male Sprague-Dawley rats.  This
classification is supported by the occurrence of thyroid C-cell adenomas and/or carcinomas in
three other rat studies, and by results from in vitro mutagenicity testing that ethoprop causes
clastogenicity. The Agency re-evaluated the carcinogenicity of ethoprop, because the registrant
submitted new historical control data and various arguments against ethoprop's cancer
classification. The Agency retained the classification of ethoprop as a "likely" human
carcinogen.

       The Agency has determined that, in addition to parent ethoprop, four of its metabolites
are also of toxicological concern in conducting risk assessments (Table 2). Parent ethoprop and
8MB and OME are included in non-cancer assessments because they are cholinesterase
inhibitors, and Ml and M2 are included because of their structural similarity with parent
ethoprop, which the Agency has determined to be a "likely" carcinogen. Ml is an important
metabolite in food and water, while M2 has been detected in water, but not as an important
residue in plant metabolite studies..

Table 2. Chemical Names of Residues of Toxicological Concern (Parent Ethoprop and its
Important Metabolites) in Various Risk Assessments Conducted
Common Name; Residue Designation
(Chemical Name)
Parent Ethoprop
(O-ethyl-S,S-dipropylphosphorodithioate)
SME; Metabolite H
(O-ethyl-S-methyl-S-propylphosphorodithioate)
OME; Metabolite ffl
(O-ethyl-O-methyl-S-propylphosphorothioate)
Ml; Metabolite IV
(O-ethyl-S-propylphosphorothioate)
Non-Cancer
(acute and chronic)
Food and Water
X
X
X

Cancer
Food
X
X
X
X
Cancer
Water
X
X
X
X
                                          14

-------
Common Name; Residue Designation
(Chemical Name)
M2
(SjSrdipropylphosphorodithioate)
Non-Cancer
(acute and chronic)
Food and Water

Cancer
Food

Cancer
Water
X
       As background for describing the results of the dietary assessments, it is also of interest to
characterize the relative oral acute toxicity of the metabolites of ethoprop. Results from an acute
oral toxicity study in the rat indicated SME has an LDSO very similar to that for parent ethoprop
(50.0 mg/kg vs 55.8 mg/kg, respectively), while OME is more toxic (LDJO of 22.4 mg/kg), but
Ml is not as toxic by the oral route (LD^ of 1608 mg/kg). Although Ml is relatively non-toxic
via the acute oral route (Toxicity Category ID), the Agency has determined that this metabolite is
of concern in the cancer risk assessments, both food and water, due to its structural similarity.
This acute oral toxicity study in the rat which compared ethoprop and some of its metabolites did
not include M2, and relative oral acute toxicity data is not available; however, due to similarity in
its chemical structure, the Agency has determined that M2 is also a metabolite of toxicological
concern for cancer (water only) assessments.

                    b. Food Quality Protection Act (FQPA) Safety Factor

       The FQPA Safety Factor (SF) to account for increased sensitivity of infants and children
was removed for ethoprop (equivalent to Ix). In evaluating ethoprop, the Agency reviewed the
ethoprop toxicity database, including developmental toxicity studies conducted in the rat and the
rabbit. In the rat study, no developmental toxicity was observed, and there was no indication of
increased sensitivity of the rat offspring at the highest dose tested (18 tag/kg/day).  In the rabbit
developmental toxicity study, neither developmental nor maternal toxicity was observed at the
highest dose tested (2.5 mg/kg/day), and there was also no indication of increased sensitivity of
the rabbit offspring.

       The Agency also evaluated a 2-generation rat reproduction study. The Agency
determined that there was no indication of increased susceptibility to offspring in this study,
because the no observable adverse effect level (NOAEL) for offspring toxicity (2.3 mg/kg/day)
was greater than the parental NOAEL (0.08 mg/kg/day).  The neurotoxicity studies with ethoprop
have also been evaluated, and no changes were observed in brain weight, brain dimensions, or
nervous system histopathology in acute and subchronic neurotoxicity studies, nor in the chronic
studies in the dog, rat, or mouse. In addition, no alterations in development of the central
nervous system were observed in the rat and rabbit developmental studies, and there were no
observations of neurotoxicity in the offspring hi the 2-generation reproduction study hi rats. On
the basis of the absence of any observed developmental effects and the lack of evidence for the
potential for exposure, the Agency concluded that the FQPA SF (lOx) should be removed
(equivalent to Ix).
                                           15

-------
                   c. Population Adjusted Dose (PAD)

       The Population Adjusted Dose (PAD) characterizes the dietary risk of a chemical, and
reflects the Reference Dose (RfD), either acute or chronic, that has been adjusted to account for
the FQPA SF. The acute PAD (aPAD) is an estimate of the one-day dietary exposure to a
pesticide residue which is believed to have no significant deleterious effects. The chronic PAD
(cPAD) is an estimate of the level of daily dietary exposure to a pesticide residue which, over a
70-year human life span, is believed to have no significant deleterious effects.

       In the case of ethoprop, the FQPA SF has been removed (equivalent to a factor of Ix), so
the acute or chronic RfD is identical to the respective aPAD or cPAD. In addition, an uncertainty
factor is determined for each chemical. In the acute and chronic dietary risk assessments for
ethoprop, the total uncertainty factor (UF) is lOOx, based on the uncertainty factor of lOx for
interspecies extrapolation and the lOx for intraspecies variability. The aPAD and cPAD are
determined by dividing the NOAEL from the selected study by the uncertainty factor and safety
factor. A risk estimate of less than 100% of the aPAD or cPAD is not of concern to the Agency.

       Ethoprop is a potent cholinesterase (ChE) inhibitor. The toxicity endpoints and doses for
dietary risk assessment are shown in Table 3. The endpoints for estimating the non-cancer risks
from exposure to ethoprop are all based on ChE inhibition hi the plasma of dogs.

Table 3. Summary of Toxicological Endpoints and Other Factors Used in Human Dietary
Risk Assessment for Ethoprop
EXPOSURE
Acute
Chronic
(Non-Cancer)
Chronic
(Cancer)
DOSE
NOAEL = 0.025
mg/kg/day
ENDPOINT
Plasma ChE inhibition at 0.07S
mg/kg/day on day 2.
STUDY
90-day Feeding study in
Dog
UF = 100 FQPASF = 1 aPAD = 0.00025 mg/kg /day
NOAEL = 0.01
mg/kg/day
Plasma ChE inhibition at 0.025
mg/kg/day.
Combined data from a 5-
mointh and a 1 -year
Gavage study in Dog
UF = 100 FQPA SF = 1 cPAD = 0.0001 mg/kg/day
Classified as a "likely" human carcinogen, due to the occurrence of malignant adrenal
pheochromocytomas in male Sprague-Dawley rats, with a Q,* = 2.81xlO"2 (mg/kg/day)*1.
                   d. Exposure Assumptions

      The Agency usually prefers to utilize data from USDA's Pesticide Data Program (PDP)
for the dietary risk assessments. However, for ethoprop, these data could not be quantitatively
used in the risk assessment, because the Agency usually requires that there be at least 100
samples for each commodity to incorporate the USD A PDP monitoring data into risk
assessments. Not enough samples were monitored among the crops for which the Agency
needed to establish ethoprop tolerances, and many of the commodity groups for which the
Agency has tolerances for ethoprop were not even included in the USDA PDP monitoring
program. In addition, the limit-of-detection (LOD) from the USDA PDP monitoring data (0.03
                                         16

-------
ppm) would yield a less refined risk estimate than using field trial data (LOD: 0.003 ppm). The
other data set which the Agency frequently utilizes, Food and Drug Administration (FDA)
monitoring data, reported that almost all the samples had non-detectable levels of ethoprop
(except for 1 trace residue among a total of 684 green bean samples, a total of 3531 samples
among all six other crops with residues were analyzed, and all were reported as less than
detectable residue levels). However, the Agency determined it would not be appropriate to use
these non-detects data quantitatively in the risk assessment, because the LOD from the FDA
monitoring data (0.0IS ppm) was higher than the LOD used in field trial data (0.003 ppm), and
would also  provide a less refined estimate of risk.

       In addition, neither the USDA PDF nor the FDA monitoring programs tested residues for
any of the ethoprop metabolites.  Therefore, the Agency utilized field trial data developed by the
registrant, based on residue analyses of both ethoprop and Ml.  These data were based on the
best analytical method currently available to the registrant. This method has been proposed by
the registrant as the enforcement method for determining residues of ethoprop and Ml, but
because of uncertainties in the method, the registrant has not yet submitted this method to the
Agency for validation.

       For the reasons discussed above, the Agency utilized field trial data for ethoprop and Ml
to perform a refined dietary assessment. The residue analyses in field trials were below the LOD
in all crops, except for lima beans, snap beans, and peanuts. It is not surprising that all the other
crops had residues which were less than the LOD because, for most agricultural field crops,
ethoprop is applied pre-plant or at-plant and is soil incorporated. However, because residue data
were submitted only for parent ethoprop and the Ml metabolite, the Agency developed a
methodology for addressing the risk from all the metabolites of toxicological concern. This
procedure was based on a calculation procedure to reflect the residues of toxicological concern
(Table 2). (For details of the metabolite estimation/calculation procedure, see the 1999 Ethoprop
Revised Human Health Risk Assessment, Executive Summary, as well as its Attachment 4:
Response to the USDA Comments to EPA's Monte Carlo Dietary Exposure Estimate for
Ethoprop and Using Further Refinements^

       Both the acute and chronic dietary risk assessments were conducted with the Dietary
Exposure Evaluation Model (DEEM) software and consumption data from USDA's 1989-1992
Continuing Survey of Food Intake by Individuals. This DEEM model utilizes a Monte Carlo
procedure for the acute dietary assessment, which results in an acute probabilistic dietary
exposure analysis. The Agency refined this analysis by using the percent crop-treated
information (Table 1), with the estimated maximum percent crop treated utilized for the acute
dietary assessment, and the weighted average percent crop treated for the chronic dietary
assessment. The exposure estimates are largely based on residue values estimated from available
field trial data and metabolism studies. The resulting residue estimates are higher than the
existing tolerances for some commodities, due to the inclusion of adjustment factors, with an
estimation procedure utilized for two of the three metabolites of concern. This is because the
existing analytical method does not provide residue data for other than Ml metabolites.
Additional refinement of dietary risk may be possible, if a refined analytical method were
validated and if additional field trials were conducted, with the submission of residue data in
                                          17

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which all the residues of concern were quantified, including parent ethoprop and the various
metabolites of lexicological concern specified in Table 2.

                    e. Food Risk Characterization

       The results of the dietary (food only) risk assessments are summarized in Table 4. These
assessments are based on the assumption that the non-detectable residues are present at one-half
the LOD for the analytical method from the respective database for each specific commodity, and
include the use of percent-crop-treated data, as well as tolerance level residues for dry lima beans
and the field trial data for  all other registered commodities.

       The acute dietary (food only) exposure for ethoprop is less than 100% of the aPAD, and
therefore is not of concern to the Agency. The population with the highest exposure was infants
younger'than 1 year old, with an estimated exposure of about 75% of the aPAD. Because
ethoprop residues were non-detectable for many commodities, and because the Agency has
employed conservative (i.e., health-protective) assumptions to account for metabolites not
measured in field trials, it is likely that the actual risks could be lower.  (See the 1999 Ethoprop
Revised Human Health Risk Assessment, Attachment 4: Response to the USDA Comments to
EPA's Monte Carlo Dietary Exposure Estimate for Ethoprop and Using Further Refinements, for
further details.)

Table 4. Dietary Exposure and Risk for Ethoprop1
Population Subgroup
U.S. Population
All Infants (
-------
 the uses supported through reregistration is estimated to be 1.1 x 10"8, and is therefore not of
 concern to the Agency. (For more information on the chronic (cancer) dietary risk assessment,
 see the 1999 Ethoprop Revised Hitman Health Risk Assessment, Attachment 5, Revised Chronic
 Dietary Exposure Analyses for the HED Risk Assessment)

             2. Dietary Risk from Drinking Water

       To determine the maximum allowable concentration from water allowed in the diet, the
 Agency first evaluates how much of the overall allowable risk is contributed by food and
 residential exposure, then the Agency determines a drinking water level of comparison
 (DWLOC) to determine whether modeled or monitoring concentrations exceed this level. The
 Agency uses the DWLOC as a surrogate to express risk associated with exposure from pesticides
 in drinking water. The DWLOC is the maximum concentration in drinking water which, when
 considered together with dietary and/or residential exposure, does not exceed 100% of the PAD
 or 1 x 10~* for cancer risk, and is not of concern to the Agency. Once the respective DWLOCs
 are calculated, they are compared with the upper bound of drinking water estimated
 concentrations (DWECs).

       Ethoprop is mobile to very mobile in soil. It has also been found to be persistent, with
 soil metabolism studies in the laboratory (both an aerobic and an anaerobic study) showing half-
 life values of about 100 days, and aquatic half-life values of 75 to 90 days from an aerobic
 sediment/water metabolism laboratory study.

       Surface Water

       There are some limited surface water monitoring data for ethoprop from various sources.
 In the Agency STORET database, from 1978 to 1997, more than 6,000 surface water samples
 were collected throughout the United States from a variety of surface water sources (lakes,
 reservoirs, streams, and canals) in many ethoprop use areas. Almost all (> 90%) samples did not
 detect ethoprop. The limits of detection (LODs) ranged from 0.003 to 1.0 ppb. The highest
 reported concentration of 3.1 ppb was sampled in Marion County, Oregon in 1994, which is
 where other samples were also measured above the limit of detection.  At that time, ethoprop was
 registered for use on turf for sod and seed, which is grown in the area and may have been treated
 at a maximum application rate of 20 Ib ai/A.  Marion County is within the Willamette Valley
 watershed, a major agricultural region, and other uses for ethoprop in this region include beans,
 sweet corn and ornamentals, which may have contributed as the source of these detections. (For
 additional details concerning the surface water monitoring data, see the Environmental Fate and
Effects Division RED Chapter for Ethoprop (October 5,1998) and the Revised ethoprop drinking
 water assessment (March 26,2001)).

       According to the United States Geological Survey National Water Quality Assessment
 (USGS NAWQA) database from 1991-1995, a total of 5,119 analyzed samples were collected
throughout the United States. The maximum reported concentration was 2.0 ppb from a sample
collected in the Willamette River Basin of Oregon. A more recent NAWQA study conducted hi
                                         19

-------
19961 focused on the Willamette River Basin. Of the 95 samples collected, 21 showed detectable
levels of ethoprop; however, the msntimnm concentration reported was 0.44 ppb.

       The South Florida Water Management District (SFWMD) also sampled surface waters
for pesticide residues, including ethoprop, from 1988 to 1993 at 27 sites.  Samples collected at
various times during the year (biannualiy to every 2 months) did not detect concentrations of
ethoprop (LODs ranged from 0.06 ppb to 0.731 ppb).  All the sugarcane grown in Florida
(approximately 428,000 acres), in addition to golf courses (approximately 44,000 acres) and
truck crops (approximately 155,000 acres), are located within the SFWMD, on which ethoprop
may have been applied. Approximately 40 tons/year of ethoprop were reported to have been
used in the SFWMD during the study period.

       Although the levels of ethoprop found in the various studies suggest that ethoprop does
not appear to exceed the DWLOCs, the reported samples were not correlated with use patterns,
were collected randomly throughout the year, and were of insufficient numbers to make
definitive statements as to extent of concentrations of ethoprop in surface waters. Additionally,
information on the site characteristics within the monitored basins would be necessary to
understand the relative vulnerability of the recipient surface waters. Thus, the DWECs are based
on modeling estimates.

       For surface water, the DWECs of ethoprop were calculated by Tier n modeling
procedures, which included PRZM-EXAMS, with the Agency Standard Index Reservoir and the
percent cropped area factor (PCA).  For all surface water model scenarios, except for ethoprop
use on corn, the default PCA value of 87% was used to predict surface water DWECs.  The
model results indicated that the surface water source DWECs exhibited the highest acute risk
concentration for use on sweet potato in Louisiana, 127 ppb (Table 5), with other acute DWECs
estimated for the following uses: tobacco in North Carolina, 92 ppb; sugar cane in Louisiana,
also  92 ppb; potatoes in Maine, 21 ppb; and corn in Ohio, 15 ppb. The chronic (non-cancer)
DWECs were the highest for use on tobacco in North Carolina, 25 ppb (Table 6), with other
chronic DWECs estimated for the following uses:  sweet potatoes in Louisiana, 22 ppb; sugar
cane in Louisiana, 12 ppb; potatoes in Maine, 8 ppb; and com in Ohio, 5 ppb. The chronic
(cancer) DWECs were the highest for use on sweet potatoes in Louisiana, 13 ppb (Table 7), with
other cancer DWECs estimated for the following uses: tobacco hi North Carolina, 8.4 ppb; sugar
cane in Louisiana, 3.9 ppb; potatoes in Maine, 3.7 ppb; and corn in Ohio, 2.6 ppb.

       Ground Water

       As with surface water, there are limited monitoring data available to assess drinking
water risks from ground water sources. The STORET database reported that over 5,300 samples
had been analyzed for ethoprop concentrations between 1981 and 1997.  Of these,  less than 0.1%
showed ethoprop detections (LODs ranged from 0.003 to 2.5 ppb), and all detected values were
less than 1 ppb.  One set of samples collected from public drinldng water wells located near
       1 Anderson CW, Wood TM, Morace JL. 1997. Distribution of Dissolved Pesticides and Other Water
Quality Constituents in Small Streams, and their Relation to Land Use, in the Willamette River Basin, Oregon, 1996.
US Geological Survey. Water Resources Investigations Report 97-4268.

                                          20

-------
Hermiston, Oregon, reported ethoprop concentrations from below the LOD of 0.03 ppb to 0.19
ppb. (For additional details concerning the ground water monitoring data, see the Environmental
Fate and Effects Division RED Chapter for Ethoprop (October 5,1998) and the Revised
ethoprop drinking water assessment (March 26,2001)).

       In addition, the USGS NAWQA database reported 2,549 samples were analyzed during
1991 to 1995 in about 20 of the major watersheds within the United States. The highest reported
concentration of 0.009 ppb occurred in an agricultural watershed. All other samples were
reported to be less than the LOD of 0.003 ppb. In addition, the EPA Pesticide in Ground Water
Database reported that 1,368 samples had been analyzed for ethoprop, but that no measurable
concentrations were reported.  It is important to note that the sampling was not conducted to
specifically identify concentrations of ethoprop in verified use areas. No information on the use
patterns of ethoprop were available at well locations, although ethoprop is known to be used hi
most of the watersheds sampled.

       Similarly, ground water DWECs for ethoprop were also developed from modeling
estimates, rather than monitoring data. Ground water DWECs were estimated by the screening-
level Tier ISCI-GROW model, which estimates the "maximum" ground water concentrations
from the application of a pesticide to crops. SCI-GROW is based on the fate properties of the
pesticide, the annual application rate, and the existing body of data from small-scale ground
water monitoring studies. The model assumes 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.  From these model
predictions, the highest DWEC was 10.1 ppb, based on crops treated at the 8 Ib a.i./A application
rate, and the next highest was 7.6 ppb for crops treated at 6 Ib a.i./A.

       Summary ofDWLOC and DWEC Comparisons

Tables.  Summary of DWLOC Calculations for Acute Risk
Population
Subgroup *
U.S. Population
Infants <1 yr
Acute PAD
(mg/kg/day)
0.00025
0.00025
Food
Exposure
(mg/kg/day)
0.000096
0.000188
Allowable
Water
Exposure
(mg/kg/day)
0.000154
0.000062
Ground
Water:
SCI-GROW
(ppb)2
10.1
10.1
Surface
Water:
PRZM-
EXAMS
(PPb)3
127
127
DWLOC
(ppb)
5
0.6
Table 6. Summary of DWLOC Calculations for Chronic Non-Cancer Risk


Population
Subgroup '
U.S. Population
Children (1-6 yrs)


Chronic PAD
(mg/kg/day)
0.0001
0.0001


Exposure
(mg/kg/day)
O.000001
0.000001
Allowable

Water
Exposure
(mg/kg/day)
0.000100
0.000099
Ground

Water:
SCI-GROW
(Ppb)2
10.1
10.1
Surface

PRZM-
EXAMS
(ppb)4
25
25


DWLOC
(PPb)
4
1
                                         21

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Table 7.  Summary of DWLOC Calculations for Chronic Cancer Risk

Population
Subgroup l

U.S. Population

Qi*
(mg/kg/day)-1

2.81XKT2

Food Exposure
(mg/kg/day)

0.000004

Allowable
Water
Exposure
(mg/kg/day)
0.000035

Ground
Water:
SCI-GROW
(PPb)*
10.1
Surface
Water:
PRZM-
FXAMS
(PPb)3
13

DWLOC
(PPb)

1
1 The infant/child subgroup with the highest exposure was used The models assume a 70 kg body wt for U.S. population and 10
kg for infants/children, and assume a water consumption of 2 L/day for adults and 1 L/day for infants and children.
2 The highest estimated ground water concentrations from SCI-GROW modeling are based on an 8 Ib ai/A application rate for
agricultural crops. The registrant has voluntarily cancelled all uses on golf course turf, which had a maximum label rate of 20 Ib
ai/A and resulted in an estimated concentration of 25 ppb.
3 The highest estimated surface water exposure from PRZM-EXAMS with Standard Index Reservoir is based on the Louisiana
sweet potatoes scenario at an application rate of 6 Ib ai/A.
4 The highest estimated chronic (non-cancer) risk surface water exposure from PRZM-EXAMS with Standard Index Reservoir is
based cm the North Carolina tobacco scenario at an application rate of 12 Ib ai/A.

       Although the Agency has determined that four ethoprop metabolites/environmental
degradates are of lexicological concern for water (cancer risk) (Table 2), the PRZM-EXAMS
with the Standard Index Reservoir modeling did not include  any of the environmental degradates
of ethoprop due to a lack of fete information. However, results from various aquatic and soil
metabolism studies indicated that none of the individual environmental degradates were ever
present at greater than about 4% of the applied ethoprop concentration. The Agency does not
generally conduct modeling for environmental degradates that account for less than 10% of the
applied radioactive parent compound. Considering the limited presence of these degradates in
the laboratory and field studies, ethoprop degradates are not  expected to add appreciably to the
concentration of total ethoprop in ground or surface water in most use areas. However, because
modeled DWECs exceed corresponding DWLOCs, additional fate information on ethoprop
degradates may be necessary to more fully understand its contribution to drinking water risks.

              3.  Occupational and Non-Occupational Risk

       Occupational workers can be exposed to ethoprop through mixing, loading, and/or
applying onto agricultural crops, loading and/or applying onto golf courses, treating ornamental
plants, hand-dipping of citrus seedlings in liquids, and re-entering sites which have been treated
with ethoprop (golf course turf maintenance workers and agricultural workers).  Since there are
no residential uses of ethoprop, there are no non-occupational risks from residential exposures;
however, there can be non-occupational exposures for golfers after golf course turf is treated with
ethoprop.

       Non-cancer dermal and inhalation risks for potentially exposed populations are assessed
by a margin of exposure (MOE) approach, which determines how close the exposure conies to
the toxicity endpoint (usually selected as a No Observed Adverse Effect Level (NOAEL) from an
animal study). The target MOE is defined by the uncertainty factor, and MOEs which are greater
than the target MOE are not of concern to the Agency. However, for MOEs below the target
level for pesticide handlers, the Agency approach is to apply further levels of worker protection
(starting with baseline clothing, and adding various personal  protective equipment (PPE), then
various engineering controls) to determine whether these levels of protection result in MOEs that
                                            22

-------
exceed the target MOE and therefore are not of concern to the Agency. In addition to the MOE
approach for worker risk assessments, cancer risk assessments are also conducted. The Agency
generally, considers occupational cancer risks of 1 x 10"* (1 in 1 million persons) or less to be
negligible, but will consider risks as high as 1 x 10"4 when all mitigation measures that are
feasible have been applied, and when evaluating the benefits associated with the use of the
pesticide.

                     a. Toxicity Profile

       The results of acute toxicity studies with ethoprop are listed in Table 8. Ethoprop is
classified in Toxicity Category I for all acute endpoints, except acute inhalation which is
classified in Toxicity Category EL

Table 8. Acute Toxicity; Technical Ethoprop
STUDY
81-1 Acute Oral - Rat
81-2 Acute Dermal -Rabbit
81-3 Acute Inhalation - Rat
81-4 Eye Irritation -Rabbit
81-5 Skin Irritation -Rabbit
81-6 Dermal Sensitization *
MRID
00078035
429795-02
00128218
00078036
00048774
N/A
RESULTS
Male: LD^ = 61.0 mg/kg
Female: LDJO = 32.8 mg/kg
LDjo = 8.5 mg/kg
LCjo = 0.123mg/L
0.1 mL killed all 3 rabbits
0.5 mL killed all 6 rabbits
N/A1
TOXICITY
CATEGORY
I
I
n
i
i
N/A
  Requirement for a Dermal Sensitization study is waived due to high acute dermal toxicity of ethoprop in rabbits.

       All risk calculations performed by the Agency are based on the most current toxicity
information available for ethoprop. The lexicological endpoints and other factors used in the
occupational and non-occupational risk assessments for ethoprop are listed in Table 9. In
addition, an uncertainty factor is determined for each toxicological endpoint. The total
uncertainty factor (UP) is lOOx, based on the uncertainty factor of lOx for interspecies
extrapolation and the lOx for intraspecies variability, for all endpoints where there is an NOAEL.

Table 9. Summary of Occupational Toxicological Endpoints for Ethoprop
EXPOSURE
Short-Term
Dermal with
Liquids
Short-Term
Dermal with
Granulars
Short-Term
Inhalation-1
DOSE
Dermal NOAEL
= 0.1 mg/kg/day
Dermal NOAEL
= 20 mg/kg/day
OralNOAEL =
0.025 mg/kg/day
ENDPOINT
Plasma, red blood cell (RBC), and brain
cholinesterase (ChE) inhibition at
1.0 mg/kg/day.
Plasma ChE inhibition at
100 mg/kg/day. 2
Plasma ChE inhibition at
0.075 mg/kg/day. 3
STUDY
(MRID No.)
21-day dermal toxicity in
rabbit with technical
(413044-04)
28-day dermal toxicity in rat
with a granular product,
Mocap 20G (450348-01)
90-day feeding hi dog with
technical (00075240)
UF
100
100
100
                                           23

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Intermediate
and Long-
Term Dermal
or Inhalation
Chronic
(Cancer)*
None
Q,* = 2.81x10*
(mg/kg/dayy1
There are currently, no intermediate- or
long-term exposures, so these risk
assessments are not required for non-
cancer risk assessments.
Classified as likely" human carcinogen,
based on malignant adrenal
pheochromocytomas in male rats.
None
Chronic
feeding/carcinogenicity in
rat (425302-01) ,
N/A
N/A
  Inhalation absorption is assumed to be equivalent to oral absorption (100%) for risk assessment purposes.
2 Although plasma ChE inhibition was observed in this study at the lowest dose tested (20 mg/kg/day), it was in
males only, and only on days 19 and 26; inhibition of RBC and brain ChE were observed in the 100 mg/kg/day dose,
but not at the lowest dose tested.
3 This toxicological endpoint is based on plasma ChE inhibition only, but is supported by a 5-month dog study, in
which the NOAEL for plasma, RBC, and brain ChE inhibition at 2 and 4 weeks were observed at the identical dose
for each compartment
4 Dermal absorption is assumed to be equivalent to oral absorption (100%) for cancer risk assessment

       The registrant submitted a 28-day dermal toxicity study in the rat with MOCAP 10G (a
10% ai granular product) to further refine the occupational risk assessment for granular products.
The Agency utilized this study for the short-term dermal toxicity endpoints for all granular
materials. For determining inhalation risks, there are no inhalation studies with ethoprop of
longer durations than 4 hours (acute exposures). Therefore, the Agency is utilizing the endpoints
from oral dosing studies.

       No dermal absorption studies are available for ethoprop.  Because the occupational cancer
risk assessment was based on an oral endpoint, an estimated dermal absorption value was
calculated by 'comparing oral and dermal endpoints from various studies.  Based on comparing
the results from a 28-day dermal and a 28-day oral study in the rabbit, the relative dermal
absorption was determined to be equivalent to oral exposure, and the 100% dermal absorption
value was retained for use in occupational cancer risk assessments.  Also, since there are no long-
term inhalation studies, the same estimation procedure was used to develop an inhalation
absorption estimate; thus, inhalation absorption was also assumed to be equivalent to the oral
exposure at 100%.

                    b. Occupational Exposure

       Data from the Pesticide Handlers Exposure Database (PHED), Version 1.1 (August,
1998) were used to complete the occupational risk assessments, including all exposure scenarios
for the liquid formulation, as well as all granular scenarios not addressed in certain studies
submitted by the registrant. Those granular-specific studies submitted by the registrant include a
product-specific worker exposure study with workers applying the 10G clay-based granular
product to potato fields at-planting, and two worker exposure studies with other chemicals being
used to treat bananas and plantains. In addition, for one set of scenarios with the granular
products (the combined loader/applicator scenarios for tractor-drawn spreaders), the risk
assessments were conducted, for comparative purposes, with exposure data both from the '
product-specific study and PHED data.

       The registrant markets the granular ethoprop in 1000 Ib plastic fiber bag packaging, called
Supersaks, used primarily by custom applicators.  The PHED database contains exposure data for
                                           24

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another chemical in 1500 Ib Supersak-like containers. Thus, for purposes of conducting
exposure assessments for the ethoprop 1000 Ib Supersaks, the Agency used PHED data to
estimate loader exposure.

       The registrant also has a registration for a gel product in water soluble packaging.
Aventis CropScience, the technical registrant, reported that this product was produced and
marketed for only one year and has since elected to voluntarily cancel the product registration;
therefore, risk calculations for this formulation were not conducted and are not included in this
document.

       Exposure data from the Pesticide Handler Exposure Database (PHED) Version 1.1 garden
hose-end sprayer scenario were also used as surrogate data for the mixing/loading/applying with
the sprinkler can. However, there are neither exposure data nor pesticide application information
available for mixing/loading/applying liquid concentrate by handheld measuring containers or for
dipping seedlings in liquid formulations, so these scenarios are referenced in the Table 11 as "No
Data."

       When the May 18,2000 revised risk assessment was conducted for ethoprop, a short-term
exposure was defined as less than 7 days, and an intermediate-term exposure was from 7 days to
several months, so both short- and intermediate exposure and risk were assessed for ethoprop.
On June 6,2001, the Agency revised these definitions, and now the short-term exposure duration
is defined as lasting from 1 day to 1 month, and the intermediate-term exposure duration is now
defined as lasting from 1 to 6 months.  Because of the use pattern, it is reasonable to believe that
handlers will not treat crops with ethoprop for a duration of more than one month, and
consequently, there are no longer any intermediate-term exposure durations for ethoprop. For
instance, based on an informal survey, private potato growers will take 1 to 5 days per year to
treat their own properties. Custom potato applicators average 7 days per year and range to 20
applications per year over a 3 to 4 week interval. In addition, the available toxicity studies (i.e.,
21-/28-day dermal studies) are appropriate to assess risks to workers within this redefined short-
term duration (1 month or less).

       Chronic (long-term) occupational exposures to ethoprop also do not occur (agricultural
crops and vegetables) because the current labels specify that applications are to be made only
pre-plant, at-plant, or pre-emergent, and specify only one application per year. A few sites allow
more than one application per crop or per year (bananas/plantains and pineapples), but the
current labels specify discrete time intervals between applications; thus, it is assumed that even
custom applicators would not receive long-term, chronic exposures (i.e., greater than 180 days).

       Numerous scenarios were evaluated for mixer/loader, applicator, mixer/loader/applicator,
and flagger scenarios, based on the types of application equipment and crop sites listed on the
various ethoprop labels.  (For details, see Ethoprop Revised Human Health Bisk Assessment,
Attachment 6, Revised Occupational/Non-Occupational/Residential Exposure Assessment for the
Reregistration Eligibility Decision, September 2,1999, as well as Ethoprop: Revised
Occupational/Non-Occupational/Residential Exposure Assessment For Reregistration Eligibility
Decision (RED) Document, May 18,2000.)
                                          25

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       Use patterns, application methods, application rates, and daily amount treated were
derived from current labeling, as well as based on information concerning typical use practices
submitted by Aventis CropScience that have been verified by the Agency. Application rates
specified on current ethoprop labels range from 0.1323 pounds of active ingredient per acre (Ib
ai/A) for bananas and plantains to 12.0 Ib ai/A for tobacco and white potatoes in agricultural
settings.  (In addition, the current ethoprop labels permit golf course turf treatments at application
rates of up to 20 Ib ai/A, but all golf course turf uses are being voluntarily cancelled.).

       The types of protection, including personal protective equipment (PPE) and engineering
controls, that are the basis for exposure during ethoprop activities in the risk assessments include:
       Baseline:
       Minimum PPE:
       Maximum PPE:
                           Long-sleeved shirt and long pants, shoes and socks.
                           Baseline clothing, plus chemical resistant gloves, and a dust/mist
                           respirator with an assumed Protection Factor (PF) of 5.
                           Coveralls over long-sleeved shirt and long pants, chemical resistant
                           gloves, and an organic vapor respirator (with an assumed PF of
                           10).
      Engineering controls: Closed mixing/loading systems, such as on-farm closed mechanical
                           transfer systems for liquids (e.g., dripless couplings) or packaging-
                           based systems for granulars (e.g., Lock 'N Load). Also enclosed
                           systems for application, such as a closed cab tractor for ground
                           equipment, closed cockpit for pilots, and closed trucks for fiaggers
                           (which for some enclosed system include air filtration to provide
                           either dermal or inhalation protection). Note that some engineering
                           controls are not feasible for certain scenarios (e.g., for handheld
                           application methods).

       On the current ethoprop labels, the equipment specified to be used by agricultural workers
includes the following:

      coveralls, either over a short-sleeved shirt and short pants (on the 10% and 15% granular
       product labels) or over a long-sleeved shirt and long pants (on the 20% granular label and
       on the labels for the EC and the gel);
      chemical-resistant footwear plus socks;
      gloves, either waterproof gloves (on the granular labels) or gloves of chemical-resistant
       materials (on the labels for the EC and the gel);
      protective eyewear (on the 20% granular label and the labels for the EC and the gel);
      chemical-resistant headgear for overhead exposure;
      chemical-resistant apron when cleaning equipment, mixing, or loading; and
      respirator, with a dust/mist filtering respirator (on the granular labels) or the choice of
       either an organic vapor-removing cartridge with a prefilter approved for pesticides or a
       canister approved for pesticides (on the labels for the EC and the gel).
                                          26

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       For workers using granular ethoprop products to treat golf courses, the current labels
 specify the following equipment:

       for loaders, coveralls over short-sleeved shirt and short pants, waterproof gloves, shoes
       and socks, and a dust/mist respirator; and
       for applicators, long-sleeved shirt and long pants, shoes and socks.

       Some of the ethoprop granular formulations (both the 10G and 20G product) are
 marketed in Lock 'n Load packaging, which qualify as engineering controls (closed loading
 systems) under the Worker Protection Standard; thus, the following equipment is specified for
 loaders on these product labels:

       long-sleeved shirt and long pants;
       shoes and socks;
       waterproof gloves; and
       chemical-resistant apron.

                    c. Occupational Risk Summary

       For purposes of calculating risk, a margin of exposure (MOE) is calculated.  The MOE is
 a ratio obtained by dividing the selected NOAEL by the estimated dose to which an individual is
 exposed. MOEs of 100 or greater are considered protective.

       In addition to the MOE approach for worker dermal and inhalation risk assessments,
 cancer risk assessments were also conducted for ethoprop following exposures to occupational
 handlers, post-application workers, and 'those individuals receiving non-occupational exposures
 (i.e., golfers). The Agency considers cancer risks of 1 x 10* (1 in 1 million) or less to be
 negligible.

       The anticipated use patterns and current labeling for ethoprop indicate there are numerous
 exposure scenarios, based upon the types of equipment that potentially can be used to make
 ethoprop applications. These scenarios, which serve as the basis for the quantitative exposure
 and risk assessments, are as follows:

 la     loading granulars for aerial application;
 Ib     loading granulars for tractor-drawn spreader application;
2a     mixing/loading EC for chemigation application;
2b     mixing/loading EC for groundboom application;
3a     applying granulars with fixed-wing aircraft;
3b     applying granulars with a tractor-drawn spreader;
4      applying liquids with a groundboom sprayer;
5a     loading/applying granules with a tractor-drawn spreader to treat agricultural field crops,
       with PHED exposure data;
5b     loading/applying granules with a tractor-drawn spreader to treat agricultural field crops,
       with product-specific Aventis exposure data;
5c     loading/applying granules with a tractor-drawn spreader to treat golf course turf;
                                          27

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5d    loading/applying granules with a push-type granular spreader to treat golf course turf,
       with PHED exposure data;
5e    loading/applying granules with a push-type granular spreader to treat golf course turf,
       with ORETF/Aventis exposure data;
5f    loading/applying granules by hand (includes information provided by the registrant for
       banana acres treated);
6a    mixing/loading/applying sprays with a low pressure handwand;
fib    mixing/loading/applying sprays with a backpack sprayer;
6c    loading/applying granules with a granular backpack spreader;
7      mixing/loading/applying liquids with a sprinkler can;
8      mixing/loaduig/applying liquid concentrate by handheld measuring container;
9      dipping seedlings in liquid formulations; and
10    flagging for granular application with fixed-wing aircraft.

       Non-Cancer Worker Risks

       Non-cancer risks for workers, based on cholinesterase inhibition, are presented below.
The results of the worker risk assessments with only baseline clothing indicated risk concerns for
every scenario (i.e., most MOEs are less than 1, only a very few are above 1, even at the lowest
application rates, and none of the MOEs are above 100). Therefore, to present risks with the
types of worker protection listed on current ethoprop labels and to determine what levels of
protection are needed for new labels as part of the ethoprop reregistration process, the data
summarized in this BRED document presents worker risk assessments where engineering controls
are feasible (Table 10). For some scenarios and application equipment, engineering controls are
not feasible (such as treatments with hand-held equipment).  For these scenarios, the maximum
worker protection is personal protective equipment, and these worker risk results are presented in
Table 11.  (Fox detailed presentations of results, see Ethoprop Revised Human Health Risk
Assessment, Attachment 6, Revised Occupational/Non-Occupational/Residential Exposure
Assessment for the Reregistration Eligibility Decision, September 2,1999, as well as Ethoprop:
Revised Occupationdl/Non-Occupational/Residential Exposure Assessment For Reregistration
Eligibility Decision (RED) Document, May 18,2000).

       Note that for the granular products, the inhalation MOEs are usually lower than the
dermal MOEs. Thus, the inhalation exposure is considered to be the risk driver for granular
products.  Conversely, due to the toxic properties of the liquid via the dermal route of exposure,
for the EC formulation, the dermal MOEs are lower than the inhalation MOEs.  Thus, the dermal
exposure is considered to be the risk driver for liquid products.

Granular Formulations

       For those granular product scenarios where engineering controls are feasible, which are
generally associated with use on agricultural field crops, such as potatoes, sweet potatoes,  sugar
cane and tobacco, the Agency has worker risk concerns for most of the combined (dermal plus
inhalation) exposures (Table 10).  For those granular product scenarios where no engineering
controls are possible and only PPE is feasible, which are generally associated with use on tropical
                                          28

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crops, such as bananas, plantains, and pineapples, the Agency also has worker risk concerns,
because none of the combined exposure MOEs are greater than about 11 (Table 11).

       Exposure and risk assessments for workers who are both loaders and applicators are
estimated based on both PHED exposure data (scenario 5a) and exposure data from the product-
specific study submitted by Aventis (scenario 5b). This study, conducted with the granular
ethoprop 10G product, reported passive dosimetry exposure data indicating mat worker
exposures are about 6 times greater than those with the Agency PHED exposure data, with
combined short-term loader/applicator MOEs of 1.2 and 7.2, respectively (at a label rate of 12 Ib
ai/A). Furthermore, this study provided exposure data for both SureFill Boxes (closed loading
system) and open pour boxes (not an engineering control). Thus, exposure data for workers with
PPE handling open pour boxes are assessed and are detailed in the supporting technical
documents, but are not listed in either Table 10 or 11.

       In summary, the dermal MOEs for loaders and/or applicators with maximum PPE (i.e.,
double layer clothing and chemical-resistant gloves) range from 192 to 2574, depending upon the
activity, application rate and acres treated. For these same scenarios, the  inhalation MOEs with a
respirator (protection factor of 5) range from 3.1 to 45.6, and the combined dermal and inhalation
MOEs range from 3.1 to 44.6. (For further details see Ethoprop Revised Human Health Risk
Assessment, Attachment 6, Revised Occupational/Non-Occupational/Residential Exposure
Assessment for the Reregistration Eligibility Decision, September 2,1999, as well as Ethoprop:
Revised Occupational/Non-Occupational/Residential Exposure Assessment For Reregistration
Eligibility Decision (RED) Document, May 18,2000.)

Liquid Formulations

       For ethoprop liquid formulations, the Agency has risk concerns for dermal risks and most
inhalation risks across most scenarios. For applications of the EC to agricultural field crops,
such as potatoes, sweet potatoes, and tobacco, the combined dermal and inhalation exposure
scenarios with the highest MOE with engineering controls for mixer/loaders were only about 5
(scenario 2b), and about 9 for those applying the liquid with ground-boom equipment (scenario
4).  For scenarios where engineering controls are not feasible (Table 11),  which include treatment
of ornamentals, non-bearing citrus plants, tropical fruits, and hand-dipping of citrus seedlings,
the risk estimates indicate even lower MOEs.

       Cancer Risks

       Cancer risks are also listed for the respective maximum protection scenarios, both
engineering controls (Table 10) and only PPE (Table 11). These cancer risks are based on
custom applicators making 10 applications of ethoprop per year. This is the "typical" number of
applications that custom applicators would make in a year, based on data  submitted by Aventis
CropScience and confirmed by the Agency. (For more details on occupational cancer risks,
typical application rates, typical acreages for each crop, and typical numbers of applications per
year, see Ethoprop Revised Human Health Risk Assessment, Attachment 6, Revised
Occupational/Non-Occupational/Residential Exposure Assessment for the Reregistration
Eligibility Decision, September 2,1999, as well as Ethoprop: Revised Occupational/Non-
                                          29

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Occupational/Residential Exposure Assessment For Reregistration Eligibility Decision (RED)
Document, May 18,2000.)

       For granular formulations, in those scenarios involving ground equipment where
engineering controls are feasible, some had cancer risks which were less than 1 x 10"6, and are
not of concern to the Agency, and others greater than IxlQr6 (i.e., 2.0 x lO"6 to 5.9 x W5) (Table
10).  Note that cancer risks for pilots applying granulars (scenario 3a) range from 6.9 x 10"5 to 1.4
x 10"4, and these cancer risks are of concern to the Agency. However, the registrant has agreed to
cancel all aerial applications of ethoprop.

       For the occupational exposure scenarios with the EC where engineering controls are
feasible (Table 10), most of the cancer risks are greater than 1 x 10"6, and are thus of concern to
the Agency. The only scenario with engineering controls having cancer risks exceeding 1 x 10"4
is mixing/loading for chemigation of 350 acres at 12 Ib ai/A (scenario 2a: cancer risk 2.1 x  10"4).

       For scenarios where engineering controls are not feasible, and only PPE protection is
available to workers (Table 11), cancer risks are greater than 1 x 10"4 for those
mixing/loadmg/applying with a liquid backpack sprayer (scenario 6b) and with a sprinkler can
(scenario?). These scenarios exhibit cancer risks of concern to the Agency. In addition, there
are no data for estimating cancer risks for two of the other hand-held types of equipment,
mixing/loading/applying liquid concentrate by hand-held measuring container (scenario 8) and
hand-dipping citrus seedlings in liquids (scenario 9).

Table 10. Occupational Risks for Use Scenarios for which Engineering Controls are
Feasible
Scenario
Application
Rate
Ob ai/A)
Acres
Treated
Risk Estimates with Engineering Controls
Short-Term MOEs
Dermal
Inhalation
Combined
Cancer
(10 appls/yr)
Mixers/Loaders
(la) Loading Granulars
for Aerial Application by
Fixed-Wing Aircraft
(Ib) Loading Granulars
for Application with a
Tractor-Drawn
Mechanical Spreader
(2a) Mixing/Loading EC
for Chemigation
6
12
2
6
12
20 (Golf
Course Turf)
2
. 6
12
2
350
80
40
350
80
3968
1984.
52080
17360
8681
10420
1.1
0.4
0.2
5.1
24.5
12.2
322
107
53.6
64.3
31
10
5.2
132
24.4
12.1
320
107
53.3
63.9
1.1
0.4
0.2
4.9
4.6E-6"
9.2E-6
1.8E-7
5.3E-7
1.1E-6
8.9E-7
3.4E-5
l.OE-4
2.1E-4
7.6E-6
                                           30

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Scenario

(2b) Mixing/Loading EC
for Groundboom
Application
Application
Rate
(Ibai/A)
6
12
2
6
12
Acres
Treated

80
Risk Estimates with Engineering Controls
Short-Term MOEs
Dermal
1.7
0.8
5.1
1.7
0.8
Inhalation
43.9
22.0
132
43.9
22.0
Combined
1.6
0.8
4.9
1.6
0.8
Cancer
(10 appls/yr)
2.3E-5
4.5E-5
7.6E-6
2.3E-5
4.5E-5
Applicators
(3a) Applying Granulars
with Fixed-Wing Aircraft
(3b) Applying Granulars
with a Tractor-E>rawn
Mechanical Spreader
(4) Applying Sprays with
Groundboom
6
12
2
6
12
20 (Golf
Course Turf)
2
6
12

(5a) Loading/ Applying
Granulars with Tractor-
Drawn Mechanical
Spreader, with PHED
Exposure Data
(5b) Loading/Applying
Granulars with Tractor-
Drawn Mechanical
Spreader, with Aventis
Exposure Data
(5c) Loading/Applying
Granules with Tractor-
Drawn Spreader, with
PHED Exposure Data
' 2
6
12
2
6
12
20
(Golf Course
Turf)
350

80
40

80

392
196
4167
1389
694
833
8.8
2^9
1.5
0.64
0.32
49.7
16.6
8.3
9.9
254
84.8
42.4
0.64
0.32
49.1
16.4
8.2
9.8
8.5
2.8
1.4
6.9E-5
1.4E-4
2.0E-6
6.1E-6
1.2E-5
1.1E-5
4.4E-6
1.3E-5
2.7E-5
Loaders/Applicators
80
80
40
3804
1268
634
1458
468
243
761
43.8
14.6
7.3
7.3
2.4
1.2
8.8
43.3
14.4
7.2
7.3
2.4
1.2
8.7
2.2E-6
6.7E-6
1.3E-5
9.8E-6
2.9E-5
5.9E-5
1.1E-5
31

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Scenario
Application
Rate
(Ibsd/A)

(10) Flagging for Aerial
Applications with
Granulors
6
.12
Acres
Treated
Risk Estimates with Engineering Controls
Short-Term MOEs
Dermal
Inhalation
Combined
Cancer
(10 appls/yr)
Flaggers
350
11900
5952
278
139
271
136
L4E-6
2.8E-6
Table 11. Occupational Risks for Those Use Scenarios for which Engineering Controls are
Scenario
Application
Rate
Acres
Treated or
Gallons
Applied
Risk Estimates with Personal Protective Equipment
(PPE)
Short-Term MOEs
Dermal
Inhalation
Combined
Cancer
(10 appls/yr)
Loader/Applicators and Mixer/Loader/Applicators
(5d) Loading/Applying
Granulars with Push-Type
Spreader, with PHED
Exposure Data
(5e) Loading/Applying
Granulars with Push-Type
Spreader, with Exposure
Data from ORETF/Aventis
(5f) Loading/Applying
Granulars by Hand:
additional registrant data for
ethoprop, bananas/plantains
(5f) Loading/Applying
Granulars by Hand: data
from fipronil study, applied
with spoon to
hannnqs/jlantaing
(6a) Mixing/Loading/
Applying Liquids with Low-
Pressure Hand wand Sprayer
(6b) Mixing/Loading/
Applying Liquids with
Backpack Sprayer
(6c) Loading/Applying
Granulars (Temik) with
Swissmex Backpack
Spreader
201bai/A
(Golf Course
Turf)
201bai/A
(Golf Course
Turf)
5.5 Ib ai/A
10.6 Ib ai/A
5 Ib ai/gal
5 Ib ai/gal
10.6 Ib ai/A
5A
5A
1A
5A
20 gal
20 gal
5A
19.2
58.3
0.033
13.4
0.77
0.18
266
27.8
12.5
6.8
0.74
23
23
7.9
11.3
10.3
0.033
0.70
0.74
0.18
7.6
4.0E-4
1.3E-4
1.1E-3
5.9E-4
5.0E-5
9.0E-4
3.0E-5
                                      32

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Scenario
(6c) Loading/Applying
Granulars (Fipronil) with
Horstine-Farmery
Microspread Backpack
Spreader
(7) Mixing/Loading/
Applying Liquids with
Sprinkler Can
(8) Mixing/Loading/
Applying Liquid
Concentrate by Handheld
Measuring Container
(bananas/plantains)
(9) Dipping Citrus
Seedlings in Liquids
Application
Rate
10.61bai/A
3 Ib ai/gal
6 Ib ai/gal
5.5 Ib ai/gal
0.0075
Ib ai/gal
Acres
Treated or
Gallons
Applied
5A
Igal
Igal
1 A
ND
Risk Estimates with Personal Protective Equipment
(PPE)
Short-Term MOEs
Dermal
44.2
0.56
0.27
ND1
ND
Inhalation
0.76
620
310
ND
ND
Combined
0.74
0.56
0.27
ND
ND
Cancer
(lOappls/yr)
1.9E-4
6.7E-5
1.4E-4
ND
ND
1 "ND" indicates that no data are available either in PHED or from the registrant for this scenario, even for the
Baseline Clothing scenarios.

                     d. Post-Application Exposure and Risk

      Restricted Entry Intervals

       The current labels for ethoprop list a restricted entry interval (REI) of 48 hours, with the
REI increased to 72 hours in outdoor areas where average rainfall is less than 25 inches per year.
The current labels also specify that ethoprop products be soil incorporated or watered-in; thus,
providing there is no disturbance of the soil (i.e. digging or hoeing), the Agency has no concerns
for workers re-entering a site treated with ethoprop, provided that they comply with current REIs.

       For most field crops, the current labels require that ethoprop be applied pre-plant or at-
plant. The exceptions for this pre-plant/at-plant use pattern include ethoprop applications to
potatoes until emergence of the potato shoots  (granulars only), treatment of corn during
cultivation until lay-by (granulars only), to peanut plants at pegging (granulars only), and to
mature tropical/sub-tropical plants, including pineapples (EC only), and bananas and plantains
(both granulars and EC).

       For these  field crops which may be treated post-plant, only the granular labels specify
post-plant treatment.  The current labels specify that corn treatments may be made until layby,
and the granules are to be covered with soil, "by making application immediately ahead of
cultivation equipment."  For treatment of peanuts at-pegging, the labels indicate the "pegging
treatment should  be incorporated lightly into the soil." For potatoes, the EC label indicates "do
not apply once plants have begun to emerge." All labels specify that potatoes treated pre-
plant/at-plant would require soil-incorporation (generally to 2 to 4 inches, with the EC label
                                            33

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specifying soil incorporation to 4 to 8 inches for nematodes in the Pacific Northwest); however,
the granular labels permit post-plant treatment of potatoes until emergence, and specify "If
applied after planting, apply 1/4 to 1/2 inch of water to incorporate hi soil. Uniformity of
application is important for best results." Based on these label instructions involving soil
incorporation, the Agency does not have worker risk concerns for post-application exposures for
those three field crops which may be treated after crop planting.

       Fields treated with ethoprop grown to tropical/sub-tropical plants (pineapples, bananas,
and plantains) are generally not reentered by workers to conduct routine activities required for the
production of the crop soon after the ethoprop applications. For the EC product, as well as a
24(c) Special Local Need granular 10G label for Puerto Rico, pineapples may be treated at
various times for plant crops (up to 8 times per year) or ratoon crops (up to 5 times per year)
during the growing season, with applications permitted at 2 month intervals. Because the current
EC and gel labels  establish a 120-day post-harvest interval for pineapples, and there are no other
routine activities in pineapple culture that would contribute to worker exposure, the Agency
generally has no post-application worker risk concerns for the limited number of acres of
pineapples that are hand harvested. Similarly, banana and plantain applications with the  granular
products are conducted with a backpack spreader or hand-spreading with a spoon. The current
granular labels specify that ground litter be removed before applying, and to apply evenly; then
irrigation should follow, unless during a rainy period; if applications are made during a dry
period or if irrigation is not available, then the ethoprop is to be mixed into the soil (top 2 cm or
1 inch) with a rake.  Once treated by this procedure, there are few cultural practices requiring
reentry to banana and plantain fields. Thus, the Agency has no worker concerns for post-
application exposures for pineapples or bananas and plantains.

       Post-Application Assessments for Applications to Golf Course Turf

       A post-application exposure and risk assessment was conducted for turf management
professionals (e.g., conducting mowing and movement of phis). When using both tractors and
push-type mowers following application of rates of 10 and 20 Ibs ai/A, REIs of 10 days or longer
were required before theMOEs would be greater than 100 and the workers could re-enter to
conduct such activities as mowing and maintenance (i.e., the calculated REIs are 10 days after
treatments following applications of 10 Ib ai/A, and 17 days following applications of 20 Ib
ai/A).

       In addition, post-application cancer risks were also calculated for these turf management
professionals. Using the Agency-selected transferability  factor as a basis for the cancer risk
assessment (see the Ethoprop: Revised Occupational/Non-Occupational/Residential Exposure
Assessment For Reregistration Eligibility Decision (RED) Document, May 18,2000), all cancer
risks w.ere less than 3.1X 10"7 on the day of application.

                    e. Non-Occupational Exposure and Risk

       Ethoprop is not registered for use on general turf or sod (these uses were taken off the
labels in 1995), or for applications to vegetable gardens, home ornamentals, or other residential
uses, but it is registered for use on golf course turf. Thus, to conduct the non-occupational
                                           34

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exposure and risk assessments for ethoprop, an assessment was conducted to quantify golfer risk
following ethoprop treatment of golf course turf, including treatment of the entire golf course,
fairways and roughs, in addition to tees and greens. On the day of ethoprop treatment at 10 and
20 Ibs ai/A, the calculated MOEs for golfers were 70 and 35, respectively. To exceed MOEs of
100, the risk assessment indicated that 4 or 10 days needed to elapse after these respective 10 and
20 IDS ai/A application rates before golfers could enter ethoprop treated areas.

       The cancer risks associated with golfer exposures were also calculated.  The cancer risks
were less than 1.0 x 10"7, and therefore are not of concern to the Agency.

                     f.  Incident Reports

       The review of the incident report databases for ethoprop lists some occupational instances
in which symptoms have been reported, including evidence of cholinesterase inhibition. In the
OPP Incident Data System, 6 incidents were listed, including ingestion by an adult and child, as
well as reports involving pesticide handlers, with 2 of 4 handler incidents not providing
information on the symptoms, and the other 2 incidents reporting "dizziness, nausea, headaches,
vomiting, and pinpoint/constricted pupils."  According to information available from the
National Pesticide Telecommunications Network (NPTN), of top 200 chemicals with calls
received by the NPTN, ethoprop was "ranked 182nd with 13 incidents in humans reported and 3
incidents in animals (mostly pets)." Based on a survey of the Poison Control Centers, the
information indicated that ethoprop was likely to result in "... above average evidence of effects
.... nearly twice as likely to require hospitalization as did cases due to other cholinesterase
inhibitors." However, the information from these three sources is based on a relatively small
number of incidents. '

       In addition, there are reports of incidents available from the California Department of
Food and Agriculture. Based on their records, ethoprop was ranked "76th as a cause of systemic
poisoning in California." In all, 11 cases were reported, all in 1989. Among these cases, 8
persons exhibited systemic illnesses from their exposure to ethoprop, although only 1 person was
hospitalized. Of these 8 persons, one.was a worker performing ground application, and the
remaining 7 cases were people exposed in a single incident by drift from an air-blast application
onto soil. This incident was further investigated by the California Department of Environmental
Health, which reported that there were incidents of headache, diarrhea, runny nose, sore throat,
burning/itching eyes, fever, and hay fever or asthma attacks. These symptoms were partly
attributed to the presence of n-propyl mercaptan, an ethoprop contaminate/degradate with a
strong, offensive odor. Note also that the incident resulted from air-blast application to soil, but
this type of equipment is no longer listed on ethoprop labels.

       There are also some more recent incident reports from the State of Washington (3
"possible" cases involving Mocap 10G granules). In addition, there are reports from the State of
Oregon (2 cases, each  involving workers exposed to various pesticides, including ethoprop, and
one other case involving wind drift towards a home adjacent to a nursery, before the ethoprop
was disced  into soil, in which 1 adult and 2 children showed symptoms).
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       The information available indicates that when ethoprop incidents have been reported, the
incidents have a higher probability of resulting in more serious health outcomes (such as
hospitaUzations) than other OPs. However, the Agency only has a limited number of human
incident reports from which to base conclusions on the safety of ethoprop when used in
accordance with label requirements.

             4. Aggregate Risk

       An aggregate risk assessment involves multiple routes of exposure, including food,
drinking water, and non-occupational (residential and recreational [i.e., golfer]) exposures.
Generally, all risks from these exposures must be less than 100% of the respective PAD, or have
MOEs which are greater than 100, to be not of concern to the Agency. (See the 1999 Ethoprop
Revised Human Health Risk Assessment, for details concerning the aggregate risk assessments.)

       Acute

       The acute aggregate risk assessment, by definition, addresses the one-day oral exposure,
and for ethoprop, includes only the combined risk from dietary exposures via food and drinking
water routes.  As indicated in Table 4, acute dietary (food) risk consumes 75% of the acute PAD
for all infants less than 1 year old (the most highly exposed population subgroup). Based on this
level of exposure, the calculated acute risk DWLOC is 0.6 ppb for infants less than 1 year old.
As indicated in Table 5, the estimated acute (peak) drinking water estimated concentrations
(DWECs) are 127 ppb for surface water sources, and 10.1 ppb for ground water sources where
applications were made at 8 Ib ai/A. Thus, both the surface and ground water DWECs exceed
the acute DWLOC; therefore, an acute aggregate assessment was not conducted. Since adequate
drinking water monitoring data are not available for ethoprop, the acute aggregate assessment is
based on estimated concentrations of ethoprop in drinking water from screening level models,
and may be lower than currently predicted.

       Chronic (Non-Cancer)

       The Agency defines a chronic (non-cancer) aggregate, long-term risk assessment as
involving continuous exposures of greater than 6 months in duration. Since a chronic
recreational exposure is not anticipated, the chronic (non-cancer) aggregate risk assessment for
ethoprop includes only food and drinking water routes of exposure. As indicated hi Table 4,
chronic (non-cancer) dietary (food) risk consumes 1.2% of the chronic PAD for children 1-6
years old (the most highly exposed population subgroup), and 1.0% for all infants less than 1
year old. Based on these levels of exposure, the calculated chronic (non-cancer) risk DWLOC is
1.0 ppb for infants less than 1 year old. As indicated in Table 6, the estimated chronic (average)
drinking water estimated concentrations (DWECs) are 25 ppb for surface water sources, and 25
ppb for ground water sources from golf course uses and 10.1 ppb for ground water sources where
applications were made at 8 Ib ai/A. Both the surface and ground water DWECs exceed the
chronic (non-cancer) DWLOC; therefore, an chronic (non-cancer) aggregate assessment was not
conducted-  Since adequate drinking water monitoring data are not available for ethoprop, the
chronic (non-cancer) aggregate assessment is based on estimated concentrations of ethoprop in
drinking water from screening level models, and may be lower than currently predicted.
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       Chronic (Cancer)

       By definition, the carcinogenic aggregate risk assessment includes food, drinking water,
and non-occupational/recreational (golfer) exposures.  Because the Agency's level of concern
was already exceeded for golfer risk, a carcinogenic aggregate assessment was not originally
performed. However, if exposure from golf course uses is excluded, a carcinogenic aggregate
risk assessment would be based on food and drinking water routes of exposure. The
carcinogenic dietary (food) risk was 1,1 x 10"8 for the general U.S. population.  From this
exposure, the calculated chronic (cancer) risk DWLOC is 1.0 ppb. As indicated in Table 7, the
estimated chronic (average) drinking water estimated concentrations (DWECs) are 13 ppb for
surface water sources, and 10.1 ppb for ground water sources where applications were made at 8
Ib ai/A. Both the surface and ground water DWECs exceed the chronic (cancer) DWLOC;
therefore, a carcinogenic aggregate assessment, even with non-occupational/recreational (golfer)
exposures excluded, is of concern to the Agency. Since adequate drinking water monitoring data
are not available for ethoprop, the chronic (cancer) aggregate assessment is based on estimated
concentrations of ethoprop in drinking water from screening level models, and may be lower than
currently predicted.

       Short-Term and Intermediate-Term

       By definition, the short-term aggregate risk addresses exposure durations of 1 day to 1 .
month, and intermediate-term aggregate risk addresses exposure durations of 1 to 6 months. For
ethoprop, short- and intermediate-term aggregate risk includes food, drinking water, and non-
occupational/recreational (golfer) routes of exposure.  Since the MOEs for golfer exposure
already exceeded the target MOE and are of concern, the exposures for food, drinking water, and
non-occupational/recreational activities were not combined, and these short- and intermediate-
term aggregate assessments were not conducted. However, if exposure from golf course uses are
excluded, the short- and intermediate-term aggregate risk assessment would be based on food
and drinking water exposure only, and would be identical to the chronic dietary aggregate risk
assessment discussed above.

       B. Environmental Risk Assessment

       For detailed discussions of the environmental risk assessment, see the Environmental
Fate and Effects Division RED Chapter for Ethoprop (October 5,1998, with addenda dated
10/18/98,2/18/99, 8/30/99, and 4/24/00), which is available in the Public Docket and the
Agency's web  page (www.epa.gov/pestidices/op).  A summary of ecological risk concerns is
presented below.                                               .

              1. Environmental Fate and Transport

       Ethoprop is a soluble (aqueous solubility: 843 ppm), somewhat volatile (vapor pressure:
3.5 x 10"4 mm Hg at 26C) insecticide/nematicide. Based on laboratory data, ethoprop is fairly
persistent; however, in field studies, dissipation was more rapid than expected, especially under
warm, moist conditions. The difference in half-lives between laboratory and field studies may be
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partially due to leaching/runoff, as well as to the increased soil moisture and temperature in the
field soils, which might result in increased microbial degradation and volatilization.

       Because of its high solubility and moderately low soil sorption potential (K,,: 2.1 L/kg hi
sUt loam soil; K,^: 1.08-3.78), ethoprop has the potential to contaminate surface water through
dissolved runoff. Ethoprop is, however, either mechanically incorporated or watered into the
soil, which will reduce the runoff potential.  Its persistence and mobility in laboratory studies
suggest that ethoprop and its degradates could also pose a threat to ground water resources.

       Ethoprop is stable to hydrolysis, and does not readily undergo photodegradation in water
or on soil. The results from the available aerobic soil metabolism study established a half-life of
100 days.  At 252 days post-treatment, 24.8% of the applied radioactivity was undegraded
ethoprop.  The major degradate was CO2 (accounting for 53.9% of the applied radioactivity by
the end of the study); the major nonvolatile degradates were identified as O-ethyl-S-methyl-S-
propylphosphorodithioate (SME), O-ethyl-O-methyl-S-propylphosphorodithioate (OME), and O-
ethyl-S-propylphosphorothioate (Ml), with the measured amount of each accounting for less than
4% of the applied, at every sampling interval. In addition, an anaerobic soil metabolism study
showed a similar rate of degradation, with the half-life of approximately 100 days. During the
56-day anaerobic incubation test, a total of 2.25% of the radioactivity had been volatilized, and
10.5% was remaining in the soil in an unextractable form.  The degradates OME and Ml each
accounted for less than 1% of the applied radiolabeled parent ethoprop.

       Ethoprop is considered to be mobile in soil. The Freundlich K,, values determined from a
batch equilibrium study were found to be moderately low, suggesting a limited potential for
sorption to soil. The reported ethoprop Kj values increase with an increase in the amount of
organic carbon in the soils.  Mobility information on Ml indicates that it also is highly mobile;
however, the mobility of the other degradates (OME, SME, and S,S-dipropylphosphorodithioate
[M2]) is not known; however, the similarities in structure of these compared with parent
ethoprop and Ml suggest that these other three degradates will all have similar, moderately low
soil sorption values.

       An aerobic aquatic metabolism laboratory study was conducted with sediment/water
systems. The reported data indicated a half-life value 75 days hi the sand sediment/water system,
and a half-life of 90 days in the silt loam sedimen
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             2. Ecological Risk Assessment Analysis

       The Agency's ecological risk assessment compares toxicity endpoints from ecological
toxicity studies to estimated environmental concentrations (EECs) based on environmental fate
characteristics and pesticide use data.  To evaluate the potential risk to nontarget organisms from
the use of ethoprop products, the Agency calculates a Risk Quotient (RQ), which is the ratio of
the estimated exposure concentration to the toxicity endpoint values, such as the median lethal
dose (LDSO) or the median lethal concentration (LC^). These RQ values are then compared to the
Agency's levels of concern (LOCs), which provide an indication of the relative risk that the
particular pesticide and/or use may pose for nontarget organisms. LOCs address the following
risk presumption categories: (1) acute  high: the potential for acute risk is high and regulatory
action may be warranted, in addition to restricted use classification; (2) acute restricted use: the
potential for acute risk is high, but may be mitigated through restricted use  classification; (3)
acute endangered species: endangered species may be adversely affected; and (4) chronic risk:
the potential for chronic risk is high and regulatory action may be warranted.  Currently, the
Agency does not perform assessments for acute or chronic risks to nontarget insects (except
bees), or chronic risk to birds or mammals from granular formulations.

                    a. Ecological Hazard Profile

       The testing data for terrestrial animals showed that ethoprop is moderately to very highly
toxic. Data for birds showed ethoprop to be moderately to very highly toxic,  in both acute and
subacute testing. The effects in avian reproduction testing included reductions in eggs laid, eggs
set, viable and live embryos, and in live embryos at 3 weeks. The Agency has determined that
these avian reproduction studies must  be repeated, because these data are necessary to fulfill the
test guideline. The results of acute studies on mammals indicated that ethoprop is highly toxic to
rats from both acute oral and dermal routes of exposure. Ethoprop is also reported to be
moderately toxic to honey bees.

       The laboratory data for freshwater fish showed variable results which indicated that
ethoprop is slightly to highly toxic in acute tests, with most data showing moderately toxic
effects. Ethoprop also has a potential  to affect freshwater fish in chronic tests, with significant
effects on larval growth. For freshwater invertebrates, ethoprop is very highly toxic in acute
tests, and it significantly reduced both growth and reproduction in chronic tests.  For
estuarine/marine fish, ethoprop is highly to very highly toxic in acute tests, and in chronic tests,
ethoprop significantly affected growth as well as juvenile and embryo survival. In testing with
estuarine/marine invertebrates, ethoprop is in general, moderately to very highly toxic in acute
tests, and significantly reduced the numbers of offspring produced per female and significantly
reduced the growth of male offspring  in chronic tests, and in another chronic  study, caused a
reduction in survival.

                    b. Risk to Birds and Mammals

       In assessing the ecological risks, the Agency calculates risk quotient (RQ) values, and
compares these values with the levels  of concern (LOCs).  For acute high risks, the Agency has
concerns if the RQs to terrestrial species exceed 0.5; for acute risks that may be mitigated
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through restricted use classification, the Agency has concerns if RQs exceed 0.2; for acute risks
to endangered species, the Agency has concerns if the RQs exceed 0.1; and for chronic risks and
chronic effects that may occur in endangered species, the Agency has concerns if the RQs exceed
1.0.  Based on the results of the ecological risk assessments for terrestrial animals, the Agency
has concerns regarding both the acute and chronic risks of ethoprop to both terrestrial birds and
mammals. (See the Environmental Fate and Effects Division RED Chapter for Ethoprop
[October 5,1998] for details concerning the exposure methods and risk calculations.)

       The ecological risk assessments for terrestrial animals assume that the nongranular
(liquid) products are applied by broadcast applications, and that granular products are applied by
either broadcast or banded or in furrow applications. For broadcast applications, the ethoprop is
applied onto the soil surface, but not soil incorporated. For the risk assessments where there are
banded or in furrow applications, the assessments assume that soil incorporation immediately
after application results in 15% of the product remaining on the soil surface and is available to
expose terrestrial species.

       Avian Risk

       For the liquid products, the acute high risk and chronic avian LOCs are exceeded for
single broadcast applications. At the 1 Ib ai/A application rate, the acute RQs range from 0.5 to
7.3, and the chronic RQs range from 2.0 to 32.  At the remaining maximum registered
application rate of 12 Ib ai/A, the ranges are 5.4 to 87.3 for acute RQs, and 24 to 384 for the
chronic RQs.

       Jh addition, RQs for the liquid products  have also been calculated for multiple broadcast
applications (for use on both pineapples and golf course turf [note that golf course turf use has
since been voluntarily cancelled]). At two applications at a rate of 6 Ib ai/A, the acute and
chronic avian risks are also exceeded, with the acute RQs ranging from 5 to 73 for the maximum
EEC, and 2 to 35 for time-weighted average EECs.  The respective chronic RQs ranged from 20
to 319 for maximum EECs, and 10 to 156 for time-weighted average EECs.

       For granular products, the risk assessments for broadcast applications indicated that the
acute risk avian LOG is exceeded, with RQs ranging from 0.2 to 27.8 at an application rate of 1.5
Ib ai/A, and ranging from 1.5 to 222 at the registered maximum application rate of 12 Ib ai/A. In
addition, for banded/in-furrow applications at the maximum application rates of 2 Ib ai/A to 12 Ib
ai/A, the acute RQs range from 1.1 to 3.0 for waterfowl, from 10.1 to 28.2 for upland gamebird,
and from 161.6 to 452.7 for songbirds.

       Ethoprop was reported to have been implicated in at least one bird kill, in which 9 adult
Canada Geese died in Georgia. Ethoprop was detected in the gastrointestinal tracts of the geese,
and the brain choHnesterase activity was inhibited in the three birds tested. (For additional
details concerning this bird kill incident, see the August 30,1999 addendum to the
Environmental Fate and Effects Division RED Chapter for Ethoprop document.)
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      Mammalian Risk

      For the liquid products, the acute high risk LOG is exceeded for single broadcast
applications for all feed items other than seeds, at application rates equal to or above 3 Ib ai/A,
with acute RQs for other than seeds ranging from 0.50 to 1.10. The chronic LOG is exceeded for
all feed items other than seeds at application rates equal to or above 1 Ib ai/A, with chronic RQs
for other than seeds ranging ftom 4.5 to 8.0. At an application rate of 3 Ib ai/A, the chronic LOG
is exceeded for all feed items, with chronic RQs ranging from 1.5 to 24.0.

      For banded/in-furrow granular applications, the acute high risk mammalian LOG is
exceeded at the registered maximum application rates for some of the crops assessed. At
application rates from 2 Ib ai/A to 12 Ib ai/A, the acute RQs for the various crops and size classes
of mammalian species assessed for the granular ethoprop products range from 0.4 to 77.4.

                    c. Risk to Aquatic Species

       For aquatic species, the water concentration model is based on the crops and the
respective T"a*iTnmn application rate on the labels. The aquatic LOCs that the Agency utilizes as
risk thresholds are slightly different from the terrestrial LOCs listed above; for acute high risks,
the Agency has  concerns if the RQs to aquatic species exceed 0.5; for acute risks that may be
mitigated through restricted use classification, the Agency has concerns if RQs exceed 0.1; for
acute risks to endangered aquatic species, the Agency has concerns if the RQs exceed 0.05; and
for chronic risks and chronic effects that may occur in aquatic endangered species, the Agency
has concerns if the RQs exceed 1.0. Based on the ecological risk assessment which have been
conducted for ethoprop and these levels of concern, the Agency has both acute and chronic
ecological risk concerns regarding ethoprop exposures to both freshwater fish and invertebrates,
as well as both marine/estuarine fish and invertebrates.  The only use of ethoprop that does not
result in risks of concern to aquatic species is the slit treatment to golf courses with RQ of 0.0;
however, ethoprop use on golf courses has since been cancelled.

       Risk to Freshwater Fish

       The acute RQ values reported for freshwater fish range from 0.05 to 0.4; therefore, for
some crops, the Agency has restricted use and endangered species risk concerns, but not acute
high risk concerns. The chronic risk LOG is exceeded for most modeled crop uses, because the
chronic RQs to  freshwater fish range from 0.58 to 5.6.

       The Agency also assessed fish kill incident reports for ethoprop. Six fish kills have been
reported, of which three were attributed to the use of ethoprop on golf course turf. While the
direct cause of the other three  incidents are not determined, ethoprop use on tobacco and/or corn
in the area may have been a contributing factor. Details concerning these seven fish kills are
reported in the EFED environmental risk assessment (see Environmental Fate and Effects
Division RED Chapter for Ethoprop [October 5, 1998, with addenda dated 10/18/98, 2/18/99,
8/30/99, and 4/24/00]).
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       Risk to Freshwater Invertebrates

       The acute high risk LOG is exceeded for most crops, and the acute restricted use LOG is
exceeded for all agricultural crops, with the acute RQ for freshwater invertebrates ranging from
0.34 to 3.1. The chronic LOG is exceeded for all agricultural uses, with chronic RQs for
freshwater invertebrates ranging from 17.5 to 168.8.

       Risk to Estuarine and Marine Animals

       The Agency also has concerns for the risks of ethoprop to marine and estuarine fish and
invertebrates. For all the uses, the acute high risk LOG and the chronic LOG are exceeded for
estuarine/marine fish, with acute RQs for fish ranging from 2.4 to 21.4 and chronic RQs ranging
from 2.4 to 21.7. Estuarine/marine invertebrates are more sensitive; thus, the acute RQs range
from 2.3 to 21.1, and chronic RQs range from 38.9 to 375.  Because the guideline is not fulfilled,
an estuarine/marine fish life-cycle test is required for ethoprop.

       Risks to Other Organisms

       Because ethoprop is moderately toxic to honeybees, precautions with respect to spray
drift to flowering plants should be followed. The ecological risk assessment did not indicate any
apparent risks to aquatic plants that are associated with the current uses and rates of ethoprop.

       The risk assessments for aquatic vertebrates assume that amphibians exhibit similar
toxicity profiles to the toxicity data which are available for fish. In addition, the risk assessments
also make the assumption that avian and reptilian toxicity are similar.

                    d. Risks to Endangered Species

       Endangered species LOCs for ethoprop are exceeded for birds, mammals, and both
freshwater fish and invertebrates and estuarine fish. However, there are no estuarine
invertebrates which are Federally  listed as endangered species. While moderately toxic to
insects, as indicated by the honeybee toxicity data, Federally listed insects are not likely to be
exposed from the remaining uses of ethoprop, based on the risk mitigation measures to be
implemented as part of the ethoprop IRED.

       The U.S. Fish and Wildlife Service (FWS) has assessed the potential impacts of ethoprop
on endangered species. In 1983, under EPA's "Com Cluster" consultation, risks to birds,
rpnmrnals, fish, reptiles, and aquatic species were triggered as being in jeopardy. Also in 1983,
ethoprop was evaluated under the "Soybean Cluster" consultation, and triggered risks to birds,
fish, and aquatic invertebrates (note that soybeans have subsequently been dropped from
ethoprop labels). In a case-by-case consultation in 1987 for grapes and brussels sprouts, similar
concerns for individual endangered species were listed (note that grapes and brussels sprouts
have also subsequently been dropped from ethoprop labels). In a "reinitiation" of the assessment
for all crops in 1989, the FWS found jeopardy to endangered birds and seven fish species, and
provided several Reasonable and Prudent Alternatives to remove the jeopardy determination. In
addition, the FWS had Reasonable and Prudent Measures (RPMs) to reduce incidental take of 24
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fish species, 25 mussel species, two aquatic crustaceans species, and one bird specie. These
consultations and the findings expressed in the Opinions, however, are based on old labels and
application methods, less refined risk assessment procedures, and an older approach to
consultation which is currently being revised through interagency collaboration. Because the
Agency's current assessment of ecological risks uses both more refined methods to define
ecological risks of pesticides and new data, such as that for spray drift, the RPMs in the
Biological Opinion(s) may need to be reassessed and modified based on these new approaches.
(See the August 30,1999 addendum to the Environmental Fate and Effects Division RED
Chapter for Ethoprop document for additional details concerning each of the respective
endangered species identified in the various consultations with FWS.)

       The Agency is currently engaged in a Proactive Conservation Review with FWS and the
National Marine Fisheries Service under section 7(a)(l) of the Endangered Species Act. The
objective of this review is to clarify and develop consistent processes for endangered species risk
assessments and consultations. Subsequent to the completion of this process, the Agency will
reassess the potential effects of ethoprop use to Federally listed threatened and endangered
species. At that time, the Agency will also consider any regulatory changes implemented as a
result of the ethoprop ERED. Until such time as this analysis is completed, the overall
environmental effects mitigation strategy articulated in this document and any County Specific
Pamphlets (described hi Section IV of this IRED document) which address ethoprop, will serve
as interim protection measures to reduce the likelihood that endangered and threatened species
may be exposed to ethoprop at levels of concern.
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IV. Interim Reregistration Eligibility and Risk Management Decisions

       A. Determination of Interim Reregistration Eligibility

       Section 4(g)(2)(A) of FTFRA calls for the Agency to determine, after submissions of
relevant data concerning an active ingredient, whether products containing an active ingredient
are eligible for reregistration. The Agency has previously identified and required the submission
of the generic (i.e., active ingredient-specific) data required to support reregistration of products
containing ethoprop active ingredients.

       The Agency has completed its assessment of the dietary, occupational (except for the EC
formulation), non-occupational, and ecological risks associated with use of ethoprop. Because
there are no residential uses, a residential risk assessment was not conducted, but a non-
occupational risk assessment was conducted for golfers, who may be exposed following golf
course applications. Note also that the ethoprop-specific dietary risk assessment has not
considered the cumulative effects of OPs as a class.  Based on a review of available data and
public comments on the Agency's assessments for the active ingredient ethoprop, the Agency has
sufficient information on the human health and ecological effects of ethoprop to make interim
decisions as part of the tolerance reassessment process under FFDCA and reregistration under
FIFRA, as amended by FQPA. The Agency has determined that ethoprop is eligible for
reregistration, except for the EC formulation, provided that: (i) current data gaps and additional
data needs are addressed; (ii) the risk mitigation measures outlined in this document are adopted,
and label amendments are made to reflect these measures; and (iii) the cumulative risks
considered for the OPs support a final reregistration eligibility decision (RED). The Agency is
not making a reregistration eligibility decision of the emulsifiable concentrate formulation at this
time. Certain conditions stipulated in this IKED document need to be fulfilled in order for the
Agency to make a reregistration eligibility decision for this formulation. Label changes are
described in Section V.  Appendix B identifies the generic data requirements that the Agency
reviewed as part of its interim determination of reregistration eligibility of ethoprop, and lists the
submitted studies that the Agency has found acceptable.

       Although the Agency has not yet considered cumulative risks for the OPs, the Agency is
issuing this interim assessment now in order to identify risk reduction measures that are
necessary to support the continued use of ethoprop.  Based on its current evaluation of ethoprop
alone, the Agency has determined that ethoprop products, unless labeled and used as specified in
this document, would present risks inconsistent with FIFRA. Thus, should a registrant fail to
implement any of the risk mitigation measures identified in this document, the Agency may take
regulatory action to address the risk concerns from use of ethoprop.

       When the cumulative assessment is conducted, the Agency will address any outstanding
risk concerns. For ethoprop, if all changes outlined in this document are incorporated into the
labels, then all current risks will be mitigated. But, because this is an IRED, the Agency may
take further actions, if warranted, to  finalize the reregistration eligibility decision for ethoprop
after considering the cumulative risks of the OP class.  Such an incremental approach to the
reregistration process is consistent with the Agency's goal of improving the transparency of the
reregistration and tolerance reassessment processes.  By evaluating each OP in turn and
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identifying appropriate risk reduction measures, the Agency is addressing the risks from the OPs
in as timely a manner as possible.

       Because the Agency has not yet finalized its consideration of the cumulative risks for the
OPs, this BRED does not fully satisfy the reassessment of the existing ethoprop food residue
tolerances as called for by FQPA. When the Agency has completed its consideration of the
cumulative risks for the OPs, ethoprop tolerances will be reassessed in that light At mat time,
the Agency will consider ethoprop, along with the other OP pesticides, to complete the FQPA
requirements and make a final reregistration eligibility decision. By publishing this interim
decision on reregistration eligibility and requesting mitigation measures now for the individual
chemical ethoprop, the Agency is not deferring or postponing FQPA requirements; rattier, EPA is
taking steps to assure that uses which exceed FIFRA's unreasonable risk standard do not remain
on the label indefinitely, pending completion of assessment required under the FQPA.  This
decision does not preclude the Agency from making further FQPA determinations and tolerance-
related rulemakings that may be required on this pesticide or any other in the future.

       If the Agency determines, before finalization of the RED, that any of the determinations
described in this IKED are no longer appropriate, the Agency will pursue appropriate action,
including reconsideration of any portion of this IRED.

       B. Summary of Phase 5 Comments and Responses

       When making its interim reregistration decision, the Agency took into account all the
comments received during Phase 5 of the OP Public Participation Process. These comments and
the Agency's Response to Comments document are available in the  Public Docket and/or the
Internet (www.epa.gov/pesticides/op).

       A total of nineteen comment letters were received during Phase  5. Fourteen of these
letters were received from individual growers or groups, with each of these supporting continued
use of ethoprop. However, another letter was received from an individual in the Department of
Fisheries and Wildlife at Michigan State University expressing concern regarding ethoprop,
requesting its withdrawal from all agricultural uses and also that a substitute be found for turf
use, due to its health threat to fish and wildlife populations.

       Comments were also received from the Pineapple Growers Association of Hawaii, the
International Banana Association, and two letters from the National Potato Council concerning
uses, application rates and frequencies, and agricultural practices. The Agency has evaluated the
information provided by the commenters, and has found it useful in  understanding the use of
ethoprop. The Agency has considered the views expressed and has taken the information into
account when making the IRED  concerning ethoprop use.
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       C. Regulatory Position

             1. FQPA Findings

                    a. "Risk Cup" Determination

       As part of the FQPA tolerance reassessment process, the Agency assessed the risks
associated with the organophosphate ethoprop.  The assessment was for this individual
organophosphate, and does not attempt to fully reassess these tolerances as required under
FQPA. FQPA requires the Agency to evaluate food tolerances on the basis of cumulative risk
from substances sharing a common mechanism of toxicity, such as the toxicity expressed by the
OPs through a common biochemical interaction with the cholinesterase enzyme. The Agency
will evaluate the cumulative risk posed by the entire class of OPs once the methodology is
developed and the policy concerning cumulative assessments is resolved.

       The Agency has determined that the dietary risk from exposure to ethoprop is within its
own "risk cup." In other words, if ethoprop did not share  a common mechanism of toxicity with
other chemicals, the Agency would be able to conclude today that the food tolerances for
ethoprop meet the FQPA safety standards.  In reaching this determination concerning the FQPA
safety standards, the Agency has considered the available  information on the special sensitivity of
infants and children, as well as both the chronic and acute food  exposure. An aggregate
assessment was conducted for exposures through food and drinking water.  Based on the results
of this aggregate assessment, the Agency has  determined that the human health risks from these
combined exposures are considered to be within acceptable levels. While the combined risks
from all exposures to ethoprop "fill" the aggregate risk cup, the water exposures are based on
modeling estimates and the food exposures reflect hypothetical  residues below the level of
detection of the analytical methodology.  The Agency has determined these modeling estimates
overestimate the actual drinking water and food exposures, and the Agency, therefore, has made
a regulatory determination that ethoprop does "fit" within the dietary risk cup. Except for those
tolerances that are to be revoked, the current ethoprop tolerances will remain in effect and
unchanged until a full reassessment of the cumulative risk from all organophosphate pesticides is
considered.

                    b. Tolerance Summary

       Tolerances for residues of ethoprop in/on plant raw agricultural commodities are to
continue to be expressed in terms of parent ethoprop alone (O-ethyl-S'.iS'-
dipropylphosphoroditbioate) [40 CFR 180.262 (a) and (b)].  As detailed in Table 2, the residues
of toxicological concern for primary and rotational crops include parent ethoprop and
Metabolites n, HI, and IV (respectively, SMB, OME, and  Ml).  However, the studies which have
been submitted to date concerning the data to satisfy the magnitude of the residue guidelines
have contained only residue data for the parent ethoprop and Metabolite IV (Ml). Also, the
studies accepted by the Final Registration Standard and Tolerance Reassessment (FRSTR; issued
in f 987) reported data only on parent ethoprop.  Because of these limitations, the dietary
exposure assessment conducted to support the ethoprop IRED used the available data on
ethoprop and Metabolite IV, and included conservative assumptions regarding the levels of
                                          46

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Metabolites n and HI from metabolism study data. (For further details, see Section IH.A.l.d of
this IRED document, or the 1999 Ethoprop Revised Human Health Risk Assessment, Executive
Summary, as well as its Attachment 4: Response to the USDA Comments to EPA's Monte Carlo
Dietary Exposure Estimate for Ethoprop and Using Further Refinements.)

       While the current tolerance levels of ethoprop are expressed in terms of parent ethoprop
alone, the Agency concludes that the tolerance expression should include all ethoprop residues of
lexicological concern. Therefore, to support the reregistration of ethoprop uses, the registrant
must:

      Conduct residue field trials on snap beans, cabbage, and potatoes, and submit for each
       crop, two field trials in representative geographic locations.
      Determine residues of parent ethoprop and metabolites n, m and IV, and must submit
       residue analytical methods along with the field trial data.
      Provide supporting storage stability data.

       After the data have been submitted and reviewed by the Agency, the decision to include
metabolites n, in and IV in the risk assessment and tolerance expression may be revisited. Also,
additional field trial data may be required to support the remaining registered uses.

       Note that the term "reassessed tolerances," as used in this section of the IRED, is not
meant to imply that the tolerances have been reassessed as required by FQPA. These tolerances
may only be reassessed once the cumulative risk of all of the OPs is considered, as required by
FQPA.  Rather, this ethoprop IRED provides "reassessed" tolerance levels for various
commodities, as supported by submitted residue data, only for the single OP chemical ethoprop,
and EPA will finalize these tolerances after considering the required cumulative risks for all the
OPs.

       Tolerances Listed Under 40 CFR 180.262 (a)

       Sufficient data are available to determine the adequacy of the established tolerances on
the following commodities:  bananas, beans (lima and snap), cabbage, corn (fodder, forage, fresh,
and gram), cucumbers, pineapples, potatoes, sugarcane, and sweet potatoes. Specifically,
reassessed/redefined tolerances for ethoprop residues in supported crops/commodities are
assessed at the limit of quantitation (LOQ) for the parent, 0.02 ppm, with the exception of snap
beans, for which the tolerance is 0.2 ppm, based on detectable residues in submitted field trials
(Table 12).

       For corn, the Agency had identified additional field trial data requirements  to account for
residues from post-plant uses (until layby). The registrant has agreed to delete post-plant use of
ethoprop on corn (until layby).  Provided the labels are amended to delete the post-plant use of
ethoprop on com (until layby), the tolerances can be reassessed for fresh corn, corn grain, corn
forage, and corn fodder. The registrant has also requested cancellation of all ethoprop uses on
peanuts; therefore, the tolerances for peanuts and peanut, hay are to be revoked.
                                          47

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       Because there are no longer any registered uses on mushrooms or soybeans, the tolerances
for residues in/on mushrooms and soybean commodities have recently been revoked, and these
tolerances are not listed in Table 12. In addition, the tolerances for residues in/on lima and snap
bean forage, pineapple fodder and forage, and sugarcane fodder and forage are also to be
revoked, because the Agency no longer considers these commodities to be significant livestock
feed items.

       In addition, the "(N)" designation for negligible residues, as listed in the current 40 CFR
180.262 (a) entries, is now being deleted from all those entries. The ethoprop tolerance
summary and recommended modifications in commodity definitions are presented in Table 12.

       Tolerances Listed Under 40 CFR 180.262 (b)

       The current tolerance of 0.02 ppm for parent ethoprop had been established for regional
registration on the commodity okra.  Because there are currently no registered uses for ethoprop
on okra, the tolerance for ethoprop residue in/on okra is to be revoked. (Note that the FRSTR
(1988) had reported then that the okra tolerance was "to be rescinded.")

       Residue Analytical Methods

       The Pesticide Analytical Manual (PAM),  Vol. n, lists Method I for ethoprop, which has
undergone a successful EPA method validation.  This is a gas-liquid chromatography/sulfur
microcoulometric detection method, which involves solvent extraction and then clean-up by
sweep co-distillation. PAM, Vol. n, also lists Method A, which uses the same principles as
Method I, but employs different parameters for extraction and gas chromatography. The limit of
quantitation (LOQ) for ethoprop in or on plant commodities is 0.01 ppm in each method.

       A new gas chromatography/flame phosphorus detector (GC/FPD) method has been
proposed as an enforcement method for determining residues of ethoprop and Metabolite IV in
plant commodities. The Agency determined that in some other methods evaluated, Metabolite
IV can be converted to Metabolite ni by methylation. This GC/FPD method has been validated
by an independent laboratory, with LOQs of 0.01 ppm for each analyte hi plant commodities;
however, the registrant has not yet submitted this method to the Agency for validation.

       However, the Agency has determined that there are additional metabolites of
toxicological concern, other than Metabolite IV and the parent. Therefore, the registrant shall
develop, evaluate, and validate a new method which determines parent ethoprop and Metabolite
IV, as well as SME and OME (Metabolite II and HI, respectively). The registrant must also
submit this analytical method of enforcement for Agency method validation.  In addition, the
Agency is also specifying that the registrant must conduct concurrent storage  stability studies in
conjunction with the new field trial studies, because the existing data have demonstrated stability
problems of Metabolite IV during frozen storage.
                                          48

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Table 12. Tolerance Summary for Ethoprop
Commodity
Current
Tolerance (ppm)
Tolerance
Reassessment * (ppm)
Comment/
Corrected Commodity Definition
Tolerances listed under 40 CFR 180262 (a)
Bananas
Beans, lima
Beans, lima, forage
Beans, snap
Beans, snap, forage
Cabbage
Corn, fodder
Corn, forage
Corn, fresh (inc.
sweet) (K+CWHR)
Corn, grain
Cucumbers
Peanuts
Peanut, hay
Pineapples
Pineapples, fodder
Pineapples, forage
Potatoes
Sugarcane
Sugarcane, fodder
Sugarcane, forage
Sweet potatoes
0.02 (N)2
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02
0.02
Revoke4
0.23
Revoke4
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
Revoke
Revoke
0.02
Revoke 4
Revoke4
0.02
0.02
Revoke 4
Revoke4
0.02
Banana
Bean, lima
No longer a regulated feed item.
Bean, snap, succulent
No longer a regulated feed item.

Corn, sweet, stover !
Corn, field, stover s
Corn, sweet, forage s
Corn, field, forage 5
Corn, sweet, kernel plus cob with husks
removed
Corn, field, grain
Cucumber
Will no longer be registered for this use
in the United States.
Peanut
Will no longer be registered for this use
in the United States.
Pineapple
No longer regulated feed items.
No longer regulated feed items.
Potato
Sugarcane, cane
No longer regulated feed items.
No longer regulated feed items.
Data can be translated from potatoes.
Sweetpotato
                                      49

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Commodity
Current
Tolerance (ppm)
Tolerance
Reassessment 1 (ppm)
Comment/
Corrected Commodity Definition
Tolerance with Regional Registration listed under 40 CFR 180.262 (b)
Okra
0.02
Revoke
No registered uses on okra.
 1 The term "reassessed" is not meant to imply that the tolerance has been reassessed as required by FQPA. These tolerances may
 only be reassessed once the cumulative risk of all of the OPs is considered, as requited by FQPA. Rather, the tolerance levels for
 the various commodities, as supported by submitted residue data, are for ethoprop only, as if no cumulative assessment were
 required.
 2 The "(N)" designation represents "negligible residues," as listed in current 40 CFR  180.262 entries. A Final Rule was     '
 published in the Federal Register (66 FR 38950-38955, July 26,2001), effective October 24,2001, removing mis designation
 from all entries.
 1 The reassessment by raising certain tolerances for ethoprop .from their current values will be deferred, pending the outcome of
 the consideration of the cumulative risks for all organqphosphate pesticides.
 4 A Final Rule was published in the Federal Register (66 FR 38950-38955, July 26,2001), effective October 24,2001, revoking
 the tolerance for these commodities, because these commodities are no longer considered significant animal feed items and
 therefore no longer need tolerances.
 5 These commodities do not represent "new commodities," but instead are the addition of corrected commodity definitions where
 more than one commodity had previously been included within the single current commodity.

        Codex Harmonization

        The Codex Alimentarius Commission has established maximum residue limits (MRLs)
 for "ethoprophos" (the name by which the active ingredient is known in Europe, and which has
 been adopted by the Codex Alimentarius Commission) for residues in/on various plant
 commodities (see the Guide to Codex Maximum Limits For Pesticide Residues,  Part A. 1,1995).
 Currently, the Codex MRL residue definition for "ethoprophos" includes only parent ethoprop,
 and does not include any of its metabolites, and is compatible with "reassessed" U.S. tolerances.
 However, pending the outcome of required field trial and other supporting data, if the U.S.
 tolerance definition for ethoprop is modified to include Metabolites n, TTT3 and/or IV, the Codex
MRLs and U.S. tolerances will no longer be compatible.  A comparison of the Codex MRLs and
the corresponding U.S. "reassessed" tolerances is presented in Table 13.

Table 13. Codex Maximum Residue Limits for "Ethoprophos" and Current U.S.
Tolerances
Codex
Commodity
(As Defined)
Banana
Beetroot
Cabbages, Head
encumber
Gherkin
Grapes
Lettuce, Head
Maize
MRL
(mg/kg)
0.02 (*)'
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
Step
CXL2
CXL
CXL
CXL
CXL
CXL
CXL
CXL
Reassessed U.S.
Tolerance (ppm)
0.02
None
0.02
0.02
None
None
0.02
Recommendation and Comments

Not registered for this use in the U.S.

The tolerance for cucumber includes gherkins in
theU.S.
Not registered for this use in the U.S.
Not registered for this use in the U.S.
(These commodities are listed under the definition
for "corn" in the U.S.)
                                               50

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Codex
Commodity
(As Defined)
Maize fodder
Maize forage
Melons, except
watermelon
Onion, Bulb
Peanut
Peanut fodder
Peas
Peppers
Pineapple
Pineapple fodder
Pineapple forage
Potato
Soya bean fodder
Soya bean (dry)
Strawberry
Sugar cane
Sugar cane fodder
Sugar cane forage
Sweet potato
Tomato
Turnip, Garden
MRL
(mg/kg)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
0.02 (*)
Step
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
CXL
Reassessed U.S.
Tolerance (ppm)

None
None
Revoke
Revoke
None
None
0.02
Revoke
Revoke
0.02
None
None
None
0.02
Revoke
Revoke
0.02
None
None
Recommendation and Comments

Not registered for this use in die U.S.
Not registered for this use in die U.S.
Will no longer be registered for this use in die U.S.
Will no longer be registered for this use in die U.S.
Not registered for this use in die U.S.
Not registered for tills use in die U.S.

No longer regulated as feed items in die U.S.;
tolerances to be revoked.

No longer registered for this use in the U.S.;
tolerances have been revoked.
Not registered for this use in die U.S.

No longer regulated as feed items indie U.S.;
tolerances to be revoked.

Not registered for this use in die U.S.
Not registered for this use in die U.S.
1 The asterisk (*) signifies diat die MRL was established at or about die limit of detection.
2 "CXL" indicates diat die Codex Alimentarius Commission accepted diis as die final MRL for diis commodity.

              2. Endocrine Disrupter Effects

       The Agency is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other such endocrine effects as the Administrator may designate."
Following the recommendations of its Endocrine Disrupter Screening and Testing Advisory
Committee (EDSTAC), the Agency determined that there were scientific bases for including,*as
part of the program, the androgen and thyroid hormone systems, in addition to the estrogen
hormone system.  The Agency also adopted EDSTAC's recommendation that the Program
include evaluations of potential effects in wildlife. For pesticide chemicals, the Agency will use
                                           51

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HFRA and, to the extent that effects in wildlife may help determine whether a substance may
have an effect in humans, FFDCA authority to require the wildlife evaluations.  As the science
develops and resources allow, screening of additional hormone systems may be added to the  .
Endocrine Disrupter Screening Program (EDSP). When the appropriate screening and/or testing
protocols being considered under the Agency's EDSP have been developed, ethoprop may be
subjected to additional screening and/or testing to better characterize effects related to endocrine
disruption.

       D. Regulatory Rationale

       The following is a summary of the rationale for managing the risks associated with the
current uses of ethoprop in support of the IRED. Where labeling revisions are warranted,
specific language is set forth in Table 14 of Section V of this document.

              1. Humam Health Risk Mitigation

                    a.  Dietary Mitigation

                           i) Acute Dietary (Food)

       Based on a Tier m dietary analysis, the acute dietary (food) risk estimates for the most
highly exposed subpopulation (all infants less than 1 year old) is 75% of the aPAD (Table 4).
Therefore, the acute dietary (food) risk estimates are not of concern to the Agency, and no
mitigation measures are necessary.

                           ii)  Chronic (Non-Cancer) Dietary (Food)

       The chronic (non-cancer) dietary (food) risk estimate is 1.2% of the cPAD for the most
highly exposed subpopulation (children 1-6 years old) (Table 4).  Therefore, chronic (non-cancer)
dietary (food) risks are not of concern to the Agency, and no mitigation measures are necessary.

                           iii) Cancer Dietary (Food)

       The Agency uses a cancer risk of 1 x 10"6 (1 person in 1 million) as the level having
negligible cancer risk.  For ethoprop, the estimated carcinogenic dietary (food) risk for the
general U.S. population is 1.1 x 10~8. Therefore, no mitigation measures are necessary to address
the dietary risk for cancer from food.

                          iv) Drinking Water

       The lowest acute, chronic (non-cancer), and cancer drinking water levels of comparison
(DWLOCs) for ethoprop are 0.6 ppb, 1.0 ppb, and 1.0 ppb, respectively. The modeled drinking
water estimated concentrations (DWECs) exceed the acute, chronic non-cancer, and cancer
DWLOCs for both surface water and ground water drinking water sources (Tables 5,6, and 7).
                                          52

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       The drinking water assessments for both surface and ground water sources are based on
screening-level model estimates designed to provide high-end estimates of potential pesticide
exposure. Some monitoring data are available, and the results are substantially lower than the
modeling estimates.  However, EPA cannot determine how accurately these monitoring data
reflect actual exposure owing to concerns regarding the manner in which the data were collected.
In addition, both the dietary (food) risk analysis and surface water model estimates may be
overestimates of dietary risks. Therefore, the Agency has required both surface and ground water
monitoring studies which are expected to demonstrate that actual measured drinking water
concentrations are less than the DWLOCs. However, if the results of the monitoring data should
indicate that there are drinking water exceedances of concern, the technical registrant has agreed
in a September 28,2001 letter to the Agency to drop uses from the labels until risk concerns are
fully addressed. Further details describing the Agency's risk management approach to modeled
aggregate dietary risk concerns are provided below.

       As discussed in the dietary (food) exposure section of this IRED, the dietary (food) risk
assessment is based on commodities where there were no detects (below the level of detection
[LOD]) for all crops from field trials, except for lima beans, snap beans, and peanuts.  It is not
unexpected that nearly all crops had residues which were less than the LOD, because for most
crops, ethoprop is applied pre-plant or at-plant, and is soil incorporated. Consistent with Agency
policy, for those commodities where there were no detects of ethoprop residues, the dietary
(food) risks were assessed assuming that residues are present at Vz LOD. These assumptions
resulted in 75% of the aPAD being consumed by food only (Table 4). Moreover, since the time
of this assessment, the registrant has agreed to cancel the use of ethoprop on peanuts, drop post-
plant treatment to corn, and reduce the maximum application rate for some crops, measures
which would further reduce the potential for ethoprop residues being available in treated
commodities. Because of these conservative assumptions and subsequent changes in the use of
the pesticide, the dietary (food) assessment may be an overestimate of dietary risk.

       The endpoint of red-blood cell ChE inhibition is often at a higher dose than plasma ChE
inhibition in the same study. In the case of ethoprop, had red-blood cell ChE inhibition been
selected as the dietary endpoint, this would result in an increase hi the NOAEL and PADs used to
assess dietary (food) risk.  Moreover, the endpoint and dose selected to assess dietary risk for
ethoprop were based on toxicity studies hi dogs (Table 3). However, a range-finding study for
the acute neurotoxicity study in the rat indicates a NOAEL of 0.7 mg/kg/day, based on red-blood
cell ChE inhibition at the low dose of 2 mg/kg/day.  For acute dietary exposure, this NOAEL
from the rat study is 28-times greater than the NOAEL from the dog study, which was based on
plasma ChE inhibition. Because of the observed differential sensitivity between the dog and the
rat, it may be more appropriate to select the dose from the rat study as being more representative
of human dose-response to assess dietary risk. Thus, the current endpoint and dose selected from
the dog study may overestimate the dietary (food) contribution to ethoprop aggregate risk.

       The dietary risk assessment is also based on the assumption that an individual would
consume both the high-end estimate of ethoprop concentrations in drinking water on the same
day as consuming the predicted maximum level of ethoprop residues in treated food. While
these assumptions and methods are necessary to protect against multiple combinations of
conditions and scenarios, they are inherently conservative.
                                          53

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       Accordingly, the dietary (food) risk assessment is likely an overestimate of the
contribution of ethoprop residues on food  Such an overestimate would provide for more room
in the "risk cup" for the dietary contribution from drinking water sources, and increase the
associated DWLOCs for this aggregate analysis.

       Surface Water

       Surface water DWECs were derived from the PRZM-EXAMS model with the Standard
Index Reservoir and percent cropped area (PCA) factor, and are screening level estimates
designed to provide high-end estimates of potential pesticide exposure. Model predictions
provide a screen to eliminate those chemicals that are not likely to cause concerns in drinking
water. Exceedances in drinking water risk assessments using the screening model estimates do
not necessarily mean a risk of concern actually exists, but indicate the need for better data (e.g.,
monitoring studies specific to use patterns and drinking water sources) on which to make a
finding.

       As stated above, the screening-level models to assess drinking water exposure are
designed to provide high-end estimates. For instance, except for ethoprop use on com, which
resulted in the lowest acute DWEC (15 ppb), all surface water model scenarios include the
default PCA value of 87%. This factor translates to 87% of the modeled drainage basin is
planted with crops which are treated with ethoprop.  This default value may be an overestimate
for the remaining modeled areas. Louisiana (sweet potatoes and sugar cane) and North Carolina
(tobacco) are areas which are highly mixed agricultural regions where other crops, such as corn,
beans, cucumbers, and cabbage are also grown, but these other crops are very minor in terms of
ethoprop usage, according the QUA (Table 1).  In addition, the QUA indicates that the percent
crop treated estimates for most of these crops are low, but the PRZM-EXAMS Standard Index
Reservoir assumes that 100% of the crops (of the 87% PCA) are treated with ethoprop.
Moreover, the Agency model utilizes a 172 hectare (430 acres) watershed, and it is likely that the
Louisiana and North Carolina watersheds may be planted to other crops which are not listed on
ethoprop labels.

       The model also employed other methods to provide high-end results. To estimate the 1-
in-10 year peak (acute) concentration of a pesticide in surface water, a rainfall value is generated
as an input parameter to the model. This value is extrapolated between the 3rd and 4ft highest
annual rainfall from 36 years of daily water concentrations (where available) for the modeled
region, and may represent between the 90th and the 99.9th percentile value.

       The Agency also usually utilizes the maximum application rates in surface water
modeling. However, the registrant has submitted data to the Agency concerning typical
application rates for selected crops, which are generally lower than the maximum label rate. For
example, the crop which had the highest acute DWEC (127 ppb) for surface water was sweet
potatoes based on an application rate of 6 Ib ai/A. The registrant has submitted or referenced
data sources which indicate that growers of sweet potatoes typically apply ethoprop at rates of
about 3.0 Ib ai/A.  In addition, the registrant has agreed to reduce the maximum label rate on
tobacco from 12 Ib ai/A to 6 Ib ai/A. Utilizing these typical values in the surface water model
estimates would reduce the estimated peak (acute) DWECs for ethoprop use on sweet potatoes in
                                          54

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Louisiana and tobacco in North Carolina by 2x. Similarly, the estimated chronic and cancer
DWECs may also be comparatively lower, when applying these same PCA and typical
application rate assumptions.

       In addition, some regions of the country where there is high use of ethoprop and/or those
modeled as representative use areas may not have conditions that lend to high concentrations of
ethoprop in drinking water from surface water sources. For example, two of the higher modeled
ethoprop concentrations in surface water were from its use on sweet potatoes and sugarcane in
Louisiana. However, the Agency has other information which indicates that not very many
community drinking water systems in Louisiana utilize reservoirs. Also, usage information
indicates that a large portion of the total amount of ethoprop used is applied to potatoes growing
areas of the Pacific Northwest that are low in rainfall and are often irrigated. This use practice in
such areas would significantly reduce the potential of runoff of ethoprop residues to nearby
surface water bodies that may feed to community drinking water reservoirs. The practice of
incorporating the pesticide immediately after application, which is currently stipulated on the
product labels, would also further reduce runoff potential for ethoprop.

       Furthermore, the registrant has submitted preliminary information indicating that
ethoprop and its various degradation products may be degraded by treatment with chlorine.
Thus, if any ethoprop or its environmental degradates should reach a drinking water treatment
system that employs chlorination as a disinfection procedure, it is likely that the concentrations
of ethoprop and the degradates could be reduced. Not all the United States drinking water
systems utilize chlorine disinfection, so the Agency has not factored chlorination degradation of
ethoprop or its degradates into the models for DWECs. Although the Agency recognizes that
chlorination degradation might result in lower DWECs, the Agency does not rely on information
concerning water treatment systems to mitigate concerns for drinking water.

       There are also limited monitoring data available for conducting an assessment of the
drinking water concentrations of ethoprop. Although the levels of ethoprop found in the various
monitoring studies suggest that ethoprop may be much lower than the screening level model
estimates, the reported samples were not correlated with use patterns, were collected randomly
throughout the year, and were of insufficient numbers to make definitive statements as to the
extent of concentrations of ethoprop in surface waters. Additionally, information on the site
characteristics within the monitored basins would be necessary to understand the relative
vulnerability of the recipient surface waters.  However, while the information from the surface
water monitoring databases are limited in assessing drinking water risks, these data sources
provide some insight that the modeling estimates may be higher than actual concentrations
measured in a directed monitoring program.

       Risk Mitigation

       Earlier drinking water model estimates (based on PRZM-EXAMS without the Standard
Index Reservoir) that were included in the preliminary human health risk assessment, resulted in
concentrations of ethoprop in drinking water as high as 650 ppb from broadcast applications to
golf turf. At that time, the registrant voluntarily canceled ethoprop use on golf courses; therefore,
                                          55

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refined drinking water assessment for golf course use was not conducted and is not included in
the revised human health risk assessment.

       Because modeling was employed to develop DWEC values to assess drinking water risks
for ethoprop, the Agency has some level of uncertainty of whether actual concentrations of
ethoprop in surface water sources of drinking water would be as high as the model predictions
discussed above. For many chemicals, where there are uncertainties in the modeling estimates,
the Agency relies on actual monitoring data to confirm, resultant expectations. Thus, for
ethoprop, since the DWECs exhibit exceedances from the DWLOCs, these exceedances have
triggered the need for monitoring data to evaluate actual human exposure concentrations in the
drinking water in various locations.

       To address these risk concerns and uncertainties, the registrant has committed to conduct
a 3-year sampling program involving community water systems from surface water sources in
five locations in different states to represent different use sites, crops, soil types, and rainfall
regimes. Raw (at the drinking water intake) water samples will be analyzed to determine the
concentrations of parent ethoprop and each of the four environmental degradates/metabolites of
toxicological concern (Table 2). The states and associated community water systems currently
selected for surface water monitoring include: North Carolina (Wilson system); Oregon
(Willamette River Basin [Jefferson system] and Columbia River Basin [Ontario system]);
California (Lodi system); and Louisiana (Berwick system).

       The surface water monitoring program is projected to begin early in 2002, in conjunction
with the usage of ethoprop on the various  crops treated in the respective areas selected for
monitoring.  The registrant is to submit quarterly reports for the surface water monitoring
program to the Agency to provide interim results of the study.

       The surface water sampling program is considered as confirmatory data, because the
Agency expects the actual measured surface water concentrations to be less than the DWLOCs.
However, if the results of the monitoring data should indicate that there are drinking water
exceedances of concern, the technical registrant has agreed to drop uses from its technical and
product labels until risk concerns are fully addressed.

       Ground Witter

       As with surface water sources, screening-level modeling was employed to develop
DWEC values to assess drinking water risks from ethoprop contamination of ground water
sources. Similarly, while the levels of ethoprop found in the various monitoring studies suggest
that ethoprop may be much lower than the screening-level model estimates, the information is
too limited to make definitive statements as to extent of contamination of drinking water from
ground water sources.

       For similar reasons discussed above for the surface water assessment, the Agency has
some level of uncertainty of whether actual concentrations of ethoprop in ground water sources
of Drinking water would be as high as the model predictions. Such factors include the following:
overestimation of dietary (food) exposure; maximum application rate used in the model; major
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use areas may not be vulnerable to ground water contamination; potential reduction of residues
from chlorination; and lack of measurements of high ethoprop concentrations from limited
ground water sampling programs.

      Risk Mitigation

      To confirm these expectations and refine the risks associated with exposures to drinking
water from ground water sources, the Agency is requiring ground water monitoring data to
determine actual ethoprop concentrations available in drinking water.  To satisfy the ground
water monitoring requirements, the registrant may conduct any of the following three ground
water monitoring programs:

1.    A three-year prospective ground water (PGW) program consisting of studies in three
      different regions and soil types around the country to represent the full use pattern of
      ethoprop.

2.    A three-year retrospective monitoring program of multiple fields with observation wells
      installed down gradient from previously treated fields.

3.    A sample program of existing private and Community Water System (CWS) wells in high
      use ethoprop regions with vulnerable soil conditions.

      Irrespective of the option chosen, the registrant must:

A.    Locate wells in hydrologic group A soils.

B.    Monitor near areas where ethoprop is used, and document current and historical ethoprop
      use.

C.    Establish a direct hydraulic connection between the pesticide application area and the
      aquifer volume which provides water to monitoring wells. If a connection can not be
      established, the results of monitoring concentration in the wells will be ambiguous.

D.    Provide the characteristics of the existing wells (e.g., screened interval, well diameter,
      depth to groundwater).

E.    Submit a monitoring protocol for approval.  If using option 2 or 3, the registrant must
      discuss the statistical significance of the sampled wells in relation to the population
      consuming ground water within the entire ethoprop use area.

F.    The registrant must determine the concentrations of parent ethoprop and the four
      metabolites/residues of toxicological concern, specifically SME, OME, Ml, and M2. The
      registrant must also submit quarterly reports to the Agency to document the ground water
      analyses conducted.
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       The ground water sampling program is considered as confirmatory data, because the
Agency expects the actual measured ground water concentrations to be less than the DWLOCs.
However, if the results of the monitoring data should indicate that there are drinking water
exceedances of concern, the technical registrant has agreed to drop uses from its technical and
product labels until the risk concerns are fully addressed.

                    b. Occupational Risk Mitigation

       As described in PR Notice 2000-9, Worker Risk Mitigation for Organophosphate
Pesticides, it is the Agency's policy to mitigate occupational risks to the greatest extent necessary
and feasible with personal protective equipment and engineering controls.  In managing risk,
EPA must take into account the economic, social, and environmental costs and benefits of the
pesticide's use.  A wide range of factors are considered in making risk management decisions for
worker risks. These factors include, in addition to the calculated MOEs, consideration of
pesticide exposure, incident data, the nature and severity of adverse effects, uncertainties in the
risk assessment, the cost, availability and relative risk of alternatives, and importance of the
chemical in IPM programs.

       Consistent with PR Notice 2000-9, EPA considers occupational cancer risks of 1 x 10"6 (1
in 1 million) and less to be negligible.  For risks between 1 x 10"4 and 1 x 10"6, the Agency
generally examines occupational risks to determine whether or not the benefits of use outweigh
the risks, and will seek ways to mitigate these risks. This policy allows for the consideration of a
wide range of factors in making a risk management decision for occupational risks. These
factors may include: risk to individuals, number of people exposed, weight of scientific evidence
regarding carcinogenicity, lower risk alternatives, and benefits associated with the pesticide
under review. EPA will seek to reduce the individual risks to the greatest extent feasible,
preferably to 1 x 10"6 or less. The goal is to ensure that there is an adequate level of protection
from exposure to pesticides for workers. Through the reregistration process and taking benefits
into account, additive protective clothing or equipment, or changes in application methods may
be necessary.

                          i) Agricultural Uses

       The risk assessments for workers who are mixing, loading, and applying ethoprop
indicate that the Agency has worker risk concerns for both the granular and liquid (EC and gel)
formulation products (Tables 10 and 11).  Additionally, for some scenarios, the Agency also has
cancer risk concerns for the EC formulation, as well as to a lesser degree for the granular
formulations. Therefore, there are specific mitigation measures and additional data needs which
are necessary to address these risk concerns. The measures necessary to be implemented to
address these risks of concern, and the supporting rationale for these decisions, are discussed
below.  A list of these specific measures is provided in Section 4.E (Labeling) and Table 14.

       Granular Formulations

       For the granular formulations, the primary risk concern (risk driver) is inhalation
exposure, because the products are formulated with dusty clay-based material. The current
worker risk assessments for the granular formulations are based on a product-specific worker
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exposure study completed with the clay-based 10G product. To help mitigate these risks, the
registrant has agreed for most granular products to substitute the clay with a cellulose-based
material that has been found to release less dust than the clay-based products, such as Biodac.
The registrant has submitted data which demonstrates that cellulose is a less dusty material and
will reduce the level of dust to which workers could be exposed during normal handler activities.
Based on this and other information, and the Agency believes that the risks associated with the
use of the granular formulation are below their respective targets and not of concern, and are
requiring confirmatory data to support this conclusion. Furthermore, it is clear that ethoprop
plays a significant role in controlling nemotodes and wireworms for various crops, and the
Agency believes that the benefits offered by this compound outweigh the potential risks from its
use. Further details describing the Agency's risk management approach to this risk concern is
provided below.

       Scenarios of Concern

       All loading and applying worker scenarios with the granular formulation result in
combined (dermal plus inhalation) risks which are of concern to the Agency. These scenarios
include: la,  Ib, 3a, 3b, 5a, 5b, 5c, and 10, for which engineering controls are feasible (Table 10);
and 5d, 5e, 5f, and 6c, for which engineering controls are not feasible (Table 11).

       Additionally, cancer risks for granular ethoprop formulations are also of concern to the
Agency for the scenarios which are remaining (i.e., those scenarios which are not being
voluntarily canceled by the registrant). The calculated cancer risks for all these remaining
scenarios with the granular formulations (Tables 10 and 11) range from 1.1 x 10'3 to 1.8 x 10'7.
Scenarios for the granular formulations having cancer risks greater than 1 x 10"6 are la, 3a, 3b,
5a, 5b, 5f, 6c, and 10; those scenarios that have cancer risks greater than 1 x 10"4 are 3a and 5f.

      Because of occupational and other risk concerns, including the drinking water risks
discussed earlier, the registrant has agreed to cancel ethoprop use on golf courses. Thus, risks
from scenarios 5c, 5d, and 5e, which assess risk to workers loading and applying granular
ethoprop products to treat golf course turf, and which also exhibited occupational and cancer
risks of concern, do not need to be further mitigated nor addressed in this risk management
section.

      Risk Mitigation

      To reduce occupational exposures and  to mitigate some of these risk concerns, the
registrant has agreed in a September 28,2001 letter to the Agency to cancel the 10G registration
and produce their 15G product solely with cellulose by December 31,2001.  The 15G product is
a dusty, clay-based formulation.  The cellulose-based inert ingredient has been found to release
less dust than the clay-based formulation, and may substantially reduce the inhalation exposure to
workers, the major risk driver for the current granular products.  Based on a preliminary review
of available data which indicate that inhalation exposures are about 90 times lower than for the
clay-based formulation, the Agency has determined that the 15G product formulated with
cellulose should not represent worker risks of concern to the Agency for scenarios Ib, 3b, 5a, and
5b. Further information leading to this conclusion is discussed below.
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       The 20G product will continue to be formulated as the clay-based formulation, because of
reported technical difficulties in "loading" 20% active ingredient onto cellulose-based granules
(i.e., due to the specific gravity and the density of the technical grade active ingredient, it is only
possible to load about 17% of the active ingredient, by weight, onto cellulose-based granules).
The 20G is described as an "oily" product, because of the increased amount of active ingredient
present in the 20G formulation. Based on a preliminary review of the data submitted, the Agency
has data which indicates that amount of dust released from this 20G formulation is much less
than from the clay-based 10G and 15G products, and is similar to the amount of dust released
from the 15G cellulose-based formulation. In addition, in an effort to reduce potential risks to
other handlers of ethoprop granular products (scenarios Ib and 3b), the registrant has agreed to
amend the 20G master label by deleting use on com and potatoes, thus limiting the 20G to use on
sugar cane only. To further protect handlers of the 20G product, the registrant has also agreed to
package the product in a closed transfer system (i.e., Lock 'N Load) by December 31,2001, as
defined PR Notice 2000-9 and the Worker Protection Standard.

       In addition, the current worker risk assessments were performed utilizing the same
inhalation rate (29 L/min) for all workers. However, more refined North American Free Trade
Agreement (NAFTA) breathing rates have recently become available, which the Agency intends
on using in future  risk assessments. Had the Agency utilized the NAFTA recommended values
for the breathing rate, rather than the single rate in Series 875 Group A (i.e., previously known as
Subdivision U), the worker risks would have been lower.  Series 875 Group A recommends an
inhalation rate of 29 L/min. The new NAFTA recommended inhalation rates are 8.3 L/min for
sedentary activities (e.g., driving a tractor), 16.7 L/min for light activities (e.g., flaggers and
mixer/loaders < 50 Ib containers), and 26.7 L/min for moderate activities (e.g., loading > 50 Ib
containers, handheld equipment in hilly conditions).  These inhalation rates would result in
reductions for the  current worker inhalation exposures or comparable increases in corresponding
MOEs by factors of 3.5 for tractor drivers, 1.7 for mixer/loaders and flaggers,  and  1.1 for
handheld equipment.

       Also, because of these reduced inhalation rates and decreases in the amount of dust
released from the cellulose-based formulation, which are expected to substantially reduce
potential inhalation risk, and because dermal risks are currently assessed as being very low
(dermal MOEs in excess of 1000), the Agency believes that risks to handlers of the granular
cellulose-based 15G product in 1000 Ib Supersaks are not of concern. For these reasons, no
further mitigation  measures are necessary to address risks to workers handling the cellulose-
based 15G product in 1000 Ib Supersaks.

       To further  mitigate risks to workers that load and apply granular products for aerial
applications, the registrant has agreed to cancel all  aerial applications of ethoprop granular
formulations. Also, to mitigate risks to workers from granular ethoprop applications to bananas
and plantains, which involve spoons or other direct hand-held equipment, the registrant has
agreed to cancel all spoon and hand-held equipment (except granular backpack spreaders). Thus,
in order to support a reregistration eligibility decision for ethoprop, the worker scenarios
involving bom loading and applying with fixed-wing aircraft, and flagging for aerial applications
(scenarios la, 3a, and 10, respectively), andjiand-held equipment (except granular backpack
spreaders) for applying to bananas and plantains (scenarios 5f) are to be deleted from the current
labels.
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       Reduction of Granular Dust Levels with Biodac

       The worker risks for the granular formulations presented in Tables 10 and 11 are based on
a product-specific worker exposure study conducted with the clay-based 10G product.  As stated
above, the Agency believes that a cellulose-based formulation will reduce substantially (i.e., by
as much as 90-fold) the inhalation exposure (me driver for the current granular formulation risks)
to workers that handle granular ethoprop products. In response, the registrant has submitted
some preliminary data which indicate that the amounts of dust associated with the 20G clay-
based and 15G cellulose-based formulations are much lower than the amounts of dust associated
with the current 10G clay-based and 15G clay-based formulations. These data concerning the
dust levels are based on the registrant's Perceived Dust method, which measures the amount of
small particulate matter which is released and trapped onto a filer, when placed in a rotating
drum system for a specified period of time.

       Based on this data for Perceived Dust of the ethoprop 15G cellulose-based and 20G clay-
based formulations, and to further demonstrate that the exposure estimates are lower than
currently assessed, the registrant has cited a worker exposure study (MRID 438525-01) that was
used to support the registration of the Temik 15G (15% aldicarb) product. This aldicarb product
was specifically formulated with an inert ingredient to produce a less-dusty formulation to also
reduce worker inhalation exposures of concern. The Agency's preliminary evaluation of the
submitted dust data suggests that the ethoprop 15G cellulose-based and 20G clay-based
formulations have dust levels similar to the Temik 15G.  This Temik 15G worker exposure
information was cited to be bridged with the ethoprop granular formulations to confirm that use
of less dusty inert ingredients, such as cellulose, will result hi lower inhalation exposure to
workers. Based on preliminary evaluation of this data, the Agency believes that it is appropriate
to bridge Temik 15G exposure data with ethoprop 15G cellulose-based and 20G clay-based
formulations to refine inhalation exposures for scenarios involving engineering controls
(Table 10).

       To further confirm the Agency's understanding that cellulose-based formulations release
less dust than the clay-based formulations, specialty studies to characterize the percent dust,
respirable and otherwise hi various formulations of ethoprop and aldicarb are required to be
submitted to the Agency. The type of information that comprise these studies may include, but
not be limited to: properties of cellulose-based granules themselves; the physical properties of
cellulose-based ethoprop granules; methods to collect and analyze the very small dust particles
released; determinations of whether these small particles contain ethoprop or are just fragmented
cellulose; and additional information on the Perceived Dust method (including quality control
data).  In addition, the Agency is also reserving at this time an inhalation toxicity study to refine
the inhalation endpoint and dose selected to assess inhalation risks. Pending final review and
conclusions of the confirmatory dust data and its bridging to the Temik 15G exposure data, if
further inhalation toxicity refinements are appropriate, the inhalation toxicity study will then be
required.
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       Cancer Risks

       For some of the granular ethoprop formulations, application scenarios have been
voluntarily cancelled by the registrant due to dermal and/or inhalation worker risk concerns.  Of
the remaining application methods that utilize engineering controls (scenarios Ib, 3b, 5a, 5b), the
cancer risks range from 5.9 x 10"5 to 1.8 x 10'7 (Table 10). Note that the Agency has mitigated
these risks to the greatest extent feasible.  For example, in addition to formulating the 15G
product with cellulose, engineering controls are to be implemented, including the use of closed
loading/transfer systems and enclosed cabs, and reduced maximum application rates for some
crops (i.e.,  12 Ib ai/A to 6 Ib ai/A for tobacco, and from 12 Ib ai/A to 9 Ib ai/A for treatment .
against nematodes in potatoes east of the Mississippi River). In addition, the Agency recognizes
that ethoprop is the most, if not the only, effective chemical control against wireworms, which
are one of the critical pests which infest potatoes.

       The only application scenarios which remain on the labels for which engineering controls
are not feasible (Table 11) are those involving granular backpack spreaders for treating banana
and plantain plants.  The calculated cancer risks for workers utilizing these types of equipment
(scenario 6c) are 1.9 x 10"4 (associated with the Horstine-Farmery Microspread granular spreader)
and 3.0 x 10  (associated with the Swissmex granular backpack spreader).

       The above cancer risk assessment is based on a product-specific study with the clay-based
10G formulation, and thus overstates the risks that workers will face in the future. As discussed
above, the registrant has agreed to convert their formulation processes of the granular products to
produce only less dusty granular formulations (15G cellulose-based and 20G clay-based
products).  With the conversion to these less dusty products, it is  expected that cancer risks for
the granulars will also be lower than those currently assessed and will not be of concern. Also,
information available to the Agency indicates that ethoprop is an important chemical to control
nematodes  which infest banana and plantain plants. According to the International Banana   ,
Association (TBA), ethoprop is utilized as part of an Integrated Pest Management (IPM) program
with other pesticides (including other OPs) to minimize the development of resistance by
nematodes  to each chemical product and to lessen the likelihood of accelerated microbial
degradation of the chemicals in the soil.  Therefore, provided application equipment with similar
or better performance to the Horstine-Farmery Microspread granular spreader and the Swissmex
granular backpack spreader are utilized to treat banana and plantain plants, no further mitigation
measures are necessary to address worker cancer risks for the granular formulations.

       Emulsifiable Concentrate Formulation

       Unlike the granular formulation, the risk driver for the emulsifiable concentrate (liquid)
formulation is dermal exposure. To help reduce these risks, the registrant has agreed to amend
the labels of these products to specify the use of engineering controls, including both the use of
closed loading and mixing systems, and the use of enclosed cabs  for applying. Nevertheless,
even with these measures, occupational risks are still of concern.  However, the registrant has
stated their belief that actual exposures to workers that mix/load and apply the ethoprop EC
product are lower than indicated by the risk assessment presented in this document, and that
further data would corroborate that worker risks are not of concern. To demonstrate this, the
registrant has initiated a biomonitoring study with workers who are routinely mixing/loading and
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applying the eihoprop EC product to potatoes. The study results are to be submitted to the
Agency by March 31,2002. The registrant has also agreed that if results of the biomonitoring
study and supporting pharmacokinetics data do not demonstrate acceptable risks to workers with
the EC formulation, the registrant will voluntarily cancel their registration of the EC formulation.
Because the current worker risks presently assessed are extremely high (some MOEs are less than
1) and of concern to the Agency, the Agency is not making a reregistration eligibility decision of
the EC formulation at this time; however, the conditions of reregistration eligibility for this
formulation are stipulated in this section.

       Scenarios of Concern

       All mixing/loading  and applying worker scenarios with the ethoprop EC formulation are
of concern to the Agency.  These scenarios include: 2a, 2b, and 4 for those where engineering
controls are feasible (Table 10); and 6a, 6b, 7,8, and 9 for those where engineering controls are
not feasible (Table 11).

       Cancer risks for the ethoprop EC formulation are also of concern to the Agency.  The
calculated cancer risks for all remaining scenarios with the granular formulations (Tables 10 and
11) range from 9.0 x  10"4 to 4.4 x 10"6. Those scenarios that have cancer risks greater than 1 x 10"
6 are 2a, 2b, 4,6a, fib, and 7; and those scenarios that have cancer risks greater than 1 x 10"4 are
2a, 6b, and 7. Cancer risks were not assessed for scenarios 8 and 9, because no data are available
to adequately assess these handler methods.

       Biomonitoring Study

       To address the occupational risks for the EC formulation, the registrant has agreed to
amend the current label for the EC product to specify engineering controls, including'both closed
mixing/loading and enclosed applying systems. The closed mixing/loading system involves
dripless couplings for the transfer system and closed mixing tanks, while the engineering controls
for applying include enclosed cabs for workers using groundboom equipment for treating
agricultural crops. Nevertheless, as indicated in Tables 10 and 11, even with the implementation
of these engineering controls, the combined MOEs for all EC scenarios (2a, 2b, 4, fia, fib, 7, 8,
and 9) are still well below their respective targets and are of concern to the Agency. However,
the registrant has indicated that the actual exposures to workers that mix/load and apply the
ethoprop EC product are possibly lower than indicated by the risk assessment presented in this
document, because of an extrapolation from the existing PHED data.

       To investigate this,  the registrant has volunteered to conduct a biomonitoring study with
workers who are routinely  mixing/loading and applying the ethoprop EC product to potatoes in
the Pacific Northwest. Potatoes are the crop with the highest remaining application rate and have
the highest usage. The mixer/loaders will be monitored while routinely utilizing closed loading
systems and closed mixing tanks, and applicators are to be monitored while operating enclosed
cab tractors/ground boom applicators. These workers will be monitored using conventional
industrial hygiene air sampling equipment to assess the inhalation exposures. In addition,
biological monitoring techniques will be employed to measure levels of ethoprop and its related
residues in urine samples to infer an absorbed dose in both these mixer/loaders and applicators.
The registrant submitted a detailed protocol for the conduct of the field and laboratory portions of
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this biomonitoring study, which has been reviewed by the Agency, and the registrant has agreed
to submit a final report of this biomonitoring study to the Agency by March 31,2002.

       Typically, these absorbed dose determinations are based on only a single biomarker;
therefore, these calculated estimates of the absorbed dose of ethoprop are highly dependent on an
accurate understanding of the human pharmacokinetics (PK) of ethoprop and all of its
metabolites. If the biomonitoring study provides equivocal results concerning worker exposures,
PK data may be necessary for the Agency to calculate the dose levels hi humans, based on the
concentrations of ethoprop and related metabolites found hi the urine of the exposed workers,
especially the selection of the human biomarker. To this end, the registrant has committed to
conduct a human PK study, if it is determined that additional data are needed.

       Note that the Agency recognizes the high benefits of ethoprop availability for key crops,
including especially potatoes, since ethoprop is one of the only effective chemical controls
against wireworms.  In addition, the Agency agrees with the position stated by potato growers
that the ethoprop EC formulation is effective in certain areas with limited rainfall, and that
because the EC is a liquid and can be tank mixed with other liquid insecticides (such as metam-
sodium), growers can achieve even more efficacious results against wireworms and nematodes.

       Additional Risk Reduction Measures

       To determine that ethoprop is eligible for reregistration, it is necessary for worker
scenarios of mixing/loading/applying liquids with low-pressure handwand sprayers, liquid
backpack sprayers, and sprinkler cans (scenarios 6a, 6b, and 7, respectively) to be deleted from
ethoprop labels. The registrant has voluntarily agreed to cancel all these uses and application
methods.

       For those scenarios where exposure data are not available, worker risk and cancer risk
assessments were not conducted. To support a reregistration decision of ethoprop, it is necessary
for these worker scenarios, specifically mixing/loading/applying liquid concentrate by handheld
measuring container and dipping citrus seedlings in liquids (scenarios 8 and 9, respectively), to
be deleted from ethoprop labels. The registrant has also agreed to cancel these uses and
application methods. Note that as a result of these voluntary cancellations, the only worker
scenarios which will remain on the EC formulation label are those where engineering controls
are feasible and employed.

       Cancer Risks

       Consistent with EPA's policy to reduce individual cancer risks to the greatest extent
feasible, preferably to 1 x 10*6 or less, with the implementation of engineering controls and the
deletion of various worker scenarios from ethoprop labels, the resultant cancer risks for the
remaining worker scenarios with the EC formulation (scenarios 2a, 2b, and 4) range from 2.1 x
10"4 to 4.4 x 10"6. As stated above, the Agency recognizes the benefits of ethoprop and especially
the EC formulation,  especially for potato growers, the highest use crop, as well as tobacco, sweet
potato, cabbage, and cucumber growers.
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      The highest cancer risk (2.1 x 10"4) is from scenario 2a (chemigation to 350 acres at the
highest application rate).  It is worth noting that these are the cancer risks which represent
exposures over a lifetime for custom applicators. These calculated risks represent five to ten
times the level of exposure as a private applicator, since the Agency cancer risk assessments in
Tables 10 and 11 are estimates for custom applicators who handle ethoprop for 10 applications
per year, while private applicators only handle ethoprop 1 or 2 times per year, depending on the
crop. Moreover, it is expected that data from the required biomonitoring study may also refine
the occupational cancer risk assessment. Provided the data from this study indicate dermal and
inhalation exposures are lower than the current estimates, cancer risks to workers will also be
lower than currently assessed.

      Conditions of Reregistration Eligibility

      As stated above, the current worker risks presently assessed are extremely high and of
concern to the Agency. Because of the registrant's belief that actual risks to workers with the EC
formulation are much lower than presently assessed; then- efforts to provide refined
biomonitoring and supporting PK data; and the benefits associated with the EC formulation in
certain areas with limited rainfall and its ability to be tank mixed with other liquid insecticides to
achieve  even more efficacious results; the Agency is not making a reregistration eligibility
decision of the EC formulation registration (MOCAP EC Nematicide-Insecticide, EPA Reg.
No. 264-458) at this time. The Agency is deferring its reregistration eligibility determination for
the EC formulation until the data described below are submitted or the deadline(s) for
submission of these data is reached.

1. The registrant is to provide EPA with a final report from the ongoing biomonitoring study of
mixer, loaders, and applicators working with the EC formulation by no later than March 30,
2002.

2. The registrant is to provide EPA with sufficient data comparing ethoprop metabolites in rat
and human urine, in combination with a previously submitted rodent metabolism/PK study by no
later than March 30, 2002.

3. If, upon a written review of the new PK data, the Agency determines it is not scientifically
acceptable or upgradable, and justifies the need for additional data, the registrant is to conduct a
human PK study within 12 months of Agency approval of the protocol.  It is expected that
approximately two years will be necessary for: (1) Agency review the biomonitoring and
supporting rodent PK data; (2) an Agency determination of whether additional PK or other data
are needed; and (3) registrant completion of a human PK study. Therefore, these activities
should be completed by no later than March 2004.

      The measures described above reflect commitments the registrant, Aventis CropScience
made to the Agency hi a letter dated September 28,2001. In that letter, the registrant stated that
they will provide the final report of the above biomonitoring study and data comparing ethoprop
metabolites hi rat and human urine to the Agency by no later than March 30,2002. The
registrant also stated hi the letter that if this data is not submitted to the Agency by this deadline,
they will voluntarily cancel the EC formulation registration.  Moreover, if the Agency determines
that a human PK study is necessary, the registrant also agreed hi the letter to conduct the study
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within 12 months of Agency approval of the protocol, and to voluntarily cancel and phase out the
liquid formulation if the Agency ultimately determines that the risks to workers from this
formulation are unacceptable.

       The Agency believes this approach provides ample opportunity for the registrant to
develop the data to address uncertainties in the risk assessment in support of grower identified
needs. And, in fact, the studies to provide the requisite data are currently ongoing. This
approach represents responsible environmental stewardship by establishing rigorous data
submission deadlines to ensure the worker risk assessment can be expeditiously refined and any
unreasonable risks expeditiously addressed by a voluntary registrant action.

       If the deadlines stipulated above for submission of data that are included in the data call-
in notice accompanying this IRED are not met, the registration for the EC formulation may be
subject to suspension in accordance with FIFRA Section 3(c)(2)(B). Also, if upon review of the
biomonitoring study and the supporting PK data, the Agency determines that the data is
inadequate or that the risks to workers are unacceptable, the Agency will take appropriate
regulatory action, if necessary. Such action may include determining the EC formulation is
ineligible for reregistration based on the data available at that time.

       Gel Formulation in Water-Soluble Packaging

       There are no chemical-specific studies for the gel formulation.  However, because of
concerns regarding production costs and the packaging size,  the registrant has agreed to
voluntarily cancel the registration of the gel formulation in the water-soluble packaging.

       Post-Application Risk Mitigation

       For ethoprop,  the Agency believes that the potential for post-application worker exposure
is low. Ethoprop is applied once, either pre-plant, at-plant, or pre-emergent for most field crops.
There are no routine activities for most field crops that lead to potential exposures during the
restricted entry interval. In addition, the time when crops are treated is well before plants are
mature, which mitigates the potential for post-application exposure from contact with foliage.
Note that peanuts are listed on current labels for treatment at pegging; however, the registrant has
cancelled peanuts as a crop which may  be treated with ethoprop.  Note also that corn is listed on
the current labels for treatment after plant emergence, until lay-by; however, the registrant has
also dropped all uses  on com that are post-plant.

       In addition, for all crops, ethoprop products are to be soil incorporated or watered-in
immediately after application. For these types of application methods, the Worker Protection
Standard designates the restricted entry interval (REI) to be 48 hours, or 72 hours in regions
where the annual rainfall is less than 25 inches. Therefore, the Agency has no risk concerns for
the post-application exposures to agricultural workers, and no risk mitigation measures beyond
the 48 or 72 hour REI are necessary to protect post-application field worker and crop harvesters,
providing the soil is not disturbed during the REI.
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                           ii)  Golf Course Uses

       The risks for loading and applying ethoprop to golf course turf were of concern to the
Agency (Tables 10 and 11). In addition, the Agency had concerns for golf course maintenance
workers who would re-enter the golf course after the turf had been treated to conduct such
activities as mowing and maintenance. Although the post-application cancer risks were
calculated to be less than 3.1 x 10"7on the day of application, and not of concern to the Agency
(i.e., less than 1 x 10"*), the dermal MOEs were less than 100 until 17 days following treatment at
the maximum label rate, and thus the worker risks are of concern to the Agency. Therefore, to
address these and other risk concerns, the registrants have agreed to voluntarily cancel all golf
course uses of ethoprop.

                    c. Non-Occupational Risk Mitigation

       There are no homeowner uses for ethoprop, so there are no residential and homeowner
exposures.  Regarding other types of non-occupational exposures for ethoprop, the Agency had
concerns regarding the risks to golfers playing on golf course turf which had been recently treated
with ethoprop (i.e., the MOEs for golfers exhibited risks which were of concern to the Agency
until 10 days had elapsed following treatment at the maximum label rate). Based on these golfer
risk concerns, as well as the other concerns associated with uses on golf courses, the registrants
of golf course use products have agreed to voluntarily cancel all golf course uses to mitigate
these risks.

             2. Environmental Risk Mitigation

       The Agency has ecological risk concerns regarding the acute and chronic risks of
ethoprop to terrestrial birds and mammals, freshwater fish and invertebrates, marine and
estuarine fish and invertebrates, as well as to endangered species. The ecological risk
assessments for both the EC and granular formulations exhibit RQ values which exceed the
various target levels of concern (LOCs).

                    a. Nontarget Terrestrial Organisms

       The RQs for terrestrial birds and mammals are of concern to the Agency. The avian RQ
values for the liquid product are as high as 384 for chronic risks, and RQs for granular products
are even higher, with banded/rn-furrow applications showing a maximum acute RQ value of 452.
While the terrestrial mammal RQ values are not as great, with a maximum acute RQ value of 77,
they are of concern as well.

       Laboratory testing results indicate that ethoprop is moderately toxic to very highly toxic
to terrestrial animals, both birds and mammals, from both oral  and dermal exposures. Therefore,
to help protect terrestrial birds and mammals, it is very important to minimize their potential
exposure to ethoprop products that have been applied. Soil incorporation, dropping  certain uses,
reducing maximum application rates, deleting broadcast applications for some uses,  and limiting
the number of applications are among the measures to be implemented to minimize potential
exposure to ethoprop.
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       For instance, ethoprop products are to be applied with soil incorporation following
 broadcast or banded treatment. While current labels specify soil incorporation, they are to be
 amended to specify that soil incorporation will occur during or immediately following
 application, either as part of the application equipment itself or with other equipment performing
 soil incorporation directly behind the applicator. In addition, the registrant has agreed to restrict
 current labels to limit the number of applications of ethoprop to one per season, except for use on
 bananas, plantains, and pineapple.

       For some crops, such as sugar cane, potatoes, and sweet potatoes, the banded treatment
 with ethoprop actually involves placement of the liquid or granules into the furrow with the
 planted material, and is then buried by the planting equipment. This direct burial should insure
 that essentially no ethoprop material remains on the soil surface. The ecological risk assessments
 for banded applications of the granular product assumed that 15% of the applied material remains
 on the soil surface.  However, the direct soil incorporation practices involved in the at-planting
 applications for these specific crops accounted for about 70% of the total amount of ethoprop
 applied from 1987-96 based on the Agency QUA, and about 85% of the total amount of ethoprop
 applied, based on registrant usage data from 1998-2000.

       In addition, the ecological risks of the EC formulation were assessed with scenarios
 involving ethoprop that is broadcast onto fields of short grass, tall grass, or broadleaf plants, and
 not soil incorporated. Because ethoprop is mostly applied at plant, broadcast treatment with the
 EC formulation is usually made to bare soil fields and is to be immediately incorporated into the
 soil for all  crops. Considering the lack of grass and plant vegetation in the field during treatment,
 and the immediate incorporation of ethoprop into the soil, the availability of ethoprop to remain
 on the soil  surface is significantly reduced, thereby further mitigating the exposure to terrestrial
 wildlife.

       Thus, actual exposure for terrestrial animals is likely much lower than assessed.  This
 conclusion is supported by the assessment of the golf course turf slit treatment use, in which the
 turf is mechanically lifted and the granules inserted onto the exposed soil and the turf replaced
 above the granules.  The resulting exposure for this use was assumed to be zero, indicating no
 ethoprop runs off for exposure to aquatic animals and suggesting little material would be
 available for exposure to terrestrial animals.

    ,   To further mitigate ecological risks, the registrant has agreed to reduce the maximum
 label rates for some uses of ethoprop.  The use which formerly had the highest label rate, 20 Ib
 ai/A, was golf course turf treatment, and this use has been voluntarily cancelled. For tobacco, the
 registrant has agreed to reduce the maximum label rate from 12 Ib ai/A to 6 Ibs ai/A. In addition,
 for potatoes, the registrant will be voluntarily enacting geographical restrictions for uses against
 nematodes; east of the Mississippi River, the maximum label rate against nematodes is being
 reduced from 12 Ibs ai/A to 9 Ib ai/A, but will remain at 12 Ib ai/A for uses against nematodes
 west of the Mississippi River; and for applications to treat wireworms and garden symphylans,
 the maximum label rate in the United States will remain at 6 Ib ai/A. Thus, the maximum
 application rate for new labels for ethoprop will be  12 Ib ai/A only for potatoes against
nematodes  only, and restricted to treatments west of the Mississippi River.
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       In addition, for most of the other crops, the registrant has submitted data indicating that
typical application rates utilized by growers are less than the maximum label rates. The Agency
has reviewed these data concerning.typical application rates, and has agreed that growers do hot
always utilize the maximum label rate for ethoprop products to control their pests. Thus, for
many crops, including tobacco, potatoes, and sweet potatoes, the actual exposures to terrestrial
birds and mammals associated with these lowered maximum and typical application rates may be
lower than the calculated RQ values presented to assess ecological risks.

       The Agency also recognizes that there are benefits to potato growers for using ethoprop to
treat nematodes, symphylans, and wireworms. Ethoprop is one of the only effective chemical
controls against wireworms. The Agency has also determined that there is a greater effectiveness
of the ethoprop EC formulation in certain areas with limited rainfall; in addition, because the EC
is a liquid and can be tank mixed with other liquid insecticides (such as metam-sodium), this
formulation can achieve even more efficacious results against wireworms and nematodes. These
benefits are of special concern, because recent information indicates that more than 50% of the
usage of ethoprop in the United States is on potatoes.

       Note that the Agency also recognizes the high benefits to growers as a result of the
availability of ethoprop for treatments of other crops. The Agency has information concerning
the benefits of ethoprop for treating pests in tobacco, sweet potatoes, cabbage, and cucumber.
While alternative chemicals are available for each of these crops, an assessment for each crop
indicates that the use of the alternative chemicals would be less effective as well as more
expensive.
                     A
                    b.  Nontarget Aquatic Organisms

       The highest RQ value reported for an aquatic animal species is 375, the chronic RQ for
estuarine/marine invertebrates. The freshwater fish and invertebrates are less sensitive than the
marine/estuarine fish and invertebrates, and the fish  are less sensitive than the invertebrates;
however, the estimated RQ values are of concern for most aquatic animals. The RQ values
developed to assess risks to aquatic species were based on estimates of EECs generated from the
PRZM-EXAMS model (without the Standard Index  Reservoir component which is used to assess
drinking water only), and were based on broadcast application without soil incorporation.
Based on the RQ exceedances for these aquatic animals, additional ecological risk mitigation is
warranted for ethoprop.

       However, as part of the risk management discussion addressing drinking water risk, there
were thousands of surface water samples from the STORET andNAWQA databases which
resulted in few ethoprop  detections, and where there were detections, they were significantly less
than estimates generated by the model. This information was not used to directly assess aquatic
exposures just as it was only of limited use hi assessing drinking water risks for ethoprop.  But it
does indicate that actual exposures and risks to aquatic species may be less than the modeling
predicts.

       Similar measures to address risk to terrestrial species are to be employed for aquatic
species as well, such as soil incorporation, dropping certain uses, reducing maximum application
rates, deleting broadcast  applications for some uses, and limiting the number of applications, in
                                          69

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addition to imposing buffer zones for the EC formulation. As with terrestrial species, to partly
address the risk concerns for aquatic species, the labels will be amended to specify immediate
soil incorporation either during or following all applications of ethoprop.  In addition, the
registrant has agreed to reductions in the maximum application rates for tobacco and potatoes,
and the number of applications.  Also, the Agency recognizes that for some crops, most growers
actually apply ethoprop at rates below the maximum rate listed on the label, so for these crops,
the risks estimated by the Agency may be overestimates of actual risks to aquatic species.

       In addition, the ecological risks assessments for the EC formulation included scenarios
where ethoprop is broadcast onto fields and not soil incorporated. While the Agency recognizes
that certain crop treatments and various pests may be best treated by broadcast applications,
ethoprop is to be immediately incorporated into the soil either during or following application to
all crops, thus significantly reducing the potential for ethoprop to remain on the soil surface and
be available for runoff. Thus, actual surface water concentrations to which aquatic organisms
may be potentially exposed may be lower than those predicted by the water model.

       Also, regarding the six reported fish kill incidents associated with ethoprop, three were
attributed to the use of ethoprop on golf course turf, and for the remaining three, while the direct
cause was not determined, ethoprop use on tobacco in the area may have been a contributing
factor. Note that the registrant has since cancelled ethoprop use on golf courses, and the
maximum applications rate for use on tobacco is to be reduced from 12 Ib ai/A to 6 Ib ai/A.

       In addition, the Agency has determined that buffer zones will be necessary for
applications of the EC formulation of ethoprop to any fields adjacent to surface water bodies.
The EC is applied as a liquid, and as such is more readily available for runoff than the granular
formulations, due to it being moderately mobile in soil, but with a decreased mobility in soils
with increasing organic matter. For granular products, water must be available to dissolve the
active ingredient off the granules, and this is anticipated to be a slower process than the
immediately mobile liquid active ingredient in the EC product.

       Buffer zones are currently specified on the labels for the EC formulation, having been
added to these labels in 1982, and include the following restrictions: "Do not apply within 140
feet of inland freshwater habitats," and in addition, specified the following: "Along the Atlantic
seaboard, do not apply with [sic; within] 800 feet of brackish water habitats."  Note that ethoprop
is particularly toxic to estuarine and marine organisms, so the buffer zone adjacent to these water
bodies is even larger than for freshwater habitats. Based on the toxicity and resultant RQs for
freshwater and estuarine/marine species, and the physical properties of the liquid formulation, the
current buffer zones specified on the label for the EC formulation are to remain unchanged.  The
label language for buffer zones is listed in Table 14 in Section V of this IRED document.

       In addition, as discussed as part of the risk management decision addressing risk to
terrestrial species, the Agency recognizes that there are substantial and unique benefits associated
with the use of ethoprop, due to its effectiveness against various pests and its cost-
competitiveness in comparison with some less efficacious alternative chemicals.
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       E. Labeling

       In order to remain eligible for reregistration, other use and safety information needs to be
placed on the labeling of all products containing ethoprop. For the specific labeling statements,
refer to Table 14 in Section V of this document

       Based on the risk information in Section 3, and the mitigation information in earlier parts
of this Section 4, the Agency had concerns regarding various uses of ethoprop.  In response to
these risks, the technical registrant has agreed to cancel the following uses:
             peanuts;
             citrus seedlings; and
             golf courses.

       The technical registrant has agreed to cancel the following use methods:
             all aerial applications;
             slit treatment;
             push-type spreaders;
             hand applications, including direct hand-held equipment, such as spoons;
             liquid low-pressure handwand sprayers;
             liquid backpack sprayers;
             liquids with a sprinkler can;
             mixmg/loading/applying liquid concentrate by a handheld measuring container;
             and
             hand-dipping in liquids.

       The technical registrant has agreed to modify the following use practices:
             delete post-plant treatments to corn (current labels permit applications until at-
             layby);
             delete broadcast applications of the EC to cabbage; only banded treatments are
             permitted;
             delete broadcast applications to sweet potatoes; only banded treatments are
             permitted for both the EC and granular formulations;
             drop the following crops from the current EC label:  snap and lima beans, field
             and sweet corn, and sugar cane;
             restrict the maximum number of applications for all uses to one application per
             year, except for use on bananas, plantains, and pineapples;
             reduce the maximum label rate for tobacco from 12 Ib ai/A to 6 Ib  ai/A;
             reduce the maximum label rate for potatoes to treat nematodes east of the
             Mississippi  River from 12 Ib ai/A to 9 Ib ai/A;
             reduce the maximum label rate for ornamentals from 6 Ib ai/A to 3 Ib ai/A;
             reduce the maximum label rate for granular treatments to pineapples (Special
             Local Needs label) from 12 Ib ai/A to 6 Ib ai/A; and
              specify immediate soil incorporation by mechanical equipment for all products as
             they are being applied by ground equipment, or that watering-in is to be conducted
             immediately following applications (for chemigation methods and for use on
             bananas, plantains, and pineapples only).
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       The technical registrant has agreed to cancel the following product registrations to
 support the reregistration of ethoprop:

             MOCAP 10% Granular Nematicide Insecticide (10% ethoprop; EPA Reg. No.
              264-465)
             Gel formulation in water soluble packaging (68.2% ethoprop, EPA Reg. No. 264-
              541)
       0      MOCAP Plus Nematicide-Insecticide (granular: 10.0% ethoprop and 5.6%
              disulfoton, EPA Reg. No. 264-459)
       0      MOCAP Plus 4-2 EC Nematicide-Insecticide (emulsifiable concentrate: 46.0%
              ethoprop and 23.0% disulfoton, EPA Reg. No. 264-464)
              MOCAP PCNB 3-10 Granular Nematicide-Insecticide (granular: 3.0% ethoprop
              and 10.0% pentachloronitrobenezene, EPA Reg. No. 264-475)
             HOLDEM Brand Granular Nematicide Insecticide (granular: 10.0% ethoprop and
              8.8% phorate, EPA Reg. No. 264-521)
              CHIPCO MOCAP Brand 10G GC [for golf course use] (granular: 10.0%
              ethoprop, EPA Reg. No. 432-895).

       The only other registrant with a registration of an ethoprop-containing product, Micro-Flo
 Co., has voluntarily agreed to cancel that end-use product registration, since the only crop listed
 on that label is peanuts, a crop that the technical registrant is dropping from their technical label.
 The specific product which Micro-Flo has agreed to voluntarily cancel is as follows:

              PCNB-M 10-3G (granular: 3.0% ethoprop and 10.0% pentachloronitrobenezene,
              EPA Reg. No. 51036-80).

              1. Endangered Species Statement

       The Agency has developed the Endangered Species Protection Program to identify
 pesticides whose use may cause adverse impacts on endangered and threatened species, and to
 implement mitigation measures that address these impacts.  The Endangered Species Act requires
 Federal agencies to ensure that their actions are not likely to jeopardize listed species or
 adversely modify designated critical habitat. To analyze the potential of registered pesticide uses
 to affect any particular species, the Agency puts basic toxicity and exposure data developed for
 REDs into context for individual listed species and their locations by evaluating important
 ecological parameters, pesticide use information, the geographic relationship between specific
 pesticide uses and species locations, and biological requirements and behavioral aspects of the
 particular species. This analysis will take into consideration any regulatory changes
 recommended in this IRED that are being implemented at this time. A determination that there is
 a likelihood of potential impact to a listed species may result in limitations on use of the
 pesticide, other measures to mitigate any potential impact, or consultations with the Fish and
 Wildlife Service and/or the National Marine Fisheries Service, as necessary.

       The Endangered Species Protection Program as described in a Federal Register notice (54
 FR 27984-28008, July 3,1989) is currently being implemented on an interim basis. As part of
the interim program, the Agency has developed County Specific Pamphlets that articulate many
 of the specific measures outlined in the Biological Opinions issued to  date. The Pamphlets are
                                          72

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available for voluntary use by pesticide applicators on the Agency's website at
www.epa.gov/espp. A final Endangered Species Protection Program, which may be altered from
the interim program, is scheduled to be proposed for public comment in the Federal Register
before the end of 2001.

             2. Spray Drift Management

       The Agency has been working with the Spray Drift Task Force, EPA Regional Offices
and State Lead Agencies for pesticide regulation, and other parties to develop the best spray drift
management practices. The Agency has completed its evaluation of the new data base submitted
by the Spray Drift Task Force, a group comprised of pesticide registrants, and is developing a
policy on how to appropriately apply the data and the AgDRIFT computer model to its risk
assessments for pesticides applied by air, orchard airblast, and ground hydraulic methods.  After
the policy is in place, the Agency may impose fiirther refinements in spray drift management
practices to reduce off-target drift and risks associated with aerial as well as other application
types where appropriate.

       Based on these analyses, the Agency is hi the process of developing more appropriate
label statements for spray and dust drift control to ensure that public health and the environment
is protected from unreasonable adverse effects. In August 2001, the Agency published for public
comment draft guidance for label statements ("Draft PR Notice 2001-X"
http://www.epa.gov/PR_Notices/#2001) and a Federal Register Notice, August 22,2001
(http://www.epa.gov/fedrgstr/), announcing the availability of this draft guidance for a 90-day
public comment period.  After receipt and review of comments, the Agency will publish final
guidance (PR Notice) for registrants to use in labeling their products.

       In the interim, until the Agency decides upon and publishes the final label guidance for
spray drift, registrants may choose to use the proposed statements. Registrants should refer to
and read the draft PR Notice to obtain a full understanding of the proposed guidance and its
intended applicability, exemptions for certain products, and the Agency's willingness to consider
other versions of the statements.

       Registrants may elect to adopt the appropriate sections of the proposed language below,
or a version that is equally protective, for their end-use product labeling for purposes of
complying with the deadlines for label submission as outlined in this document. This proposed
language is as follows:

       For products applied outdoors as liquids (except mosquito adulticides):

             "Do not allow spray to drift from the application site and contact people,
             structures people occupy at any time and the associated property, parks and
             recreation areas, nontarget crops, aquatic and wetland areas, woodlands, pastures,
             rangelands, or animals."

             "For ground boom applications, apply with nozzle height no more than 4 feet
             above the ground or crop canopy and when wind speed is 10 mph or less  at the
             application site as measured by an anemometer. Use	[registrant to fill in
                                          73

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             blank with spray quality, e.g.fine or medium} or coarser spray according to ASAE
             572 definition for standard nozzles or VMD for spinning atomizer nozzles."

             "For overhead chemigation, apply only when wind speed is 10 mph or less."

             "The applicator also must use all other measures necessary to control drift."

       The Agency recognizes that the above option does not address all other application types.
Registrants may, therefore, wish to choose some variation of the old and proposed new language
for their particular products, depending on their application methods.  Thus, until the Agency
decides upon and publishes the final label guidance for spray/dust drift, registrants may choose to
use the above proposed statements.

       However, if registrants do not chose to utilize the proposed new language, at a minimum,
other language is still necessary. Since the Agency has determined that spray drift related
language shall be included on all product labels that are applied outdoors hi liquid sprays (except
mosquito adulticides), regardless of application method, the following statement must be added
to ethoprop labels:

             "Do not allow this product to drift."

       To mitigate risk concerns for granular products, the registrant for ethoprop has agreed to
delete aerial applications. The current EC label does not permit aerial applications. Thus, any
spray drift language to address aerial applications should not be included on any revised labels to
be submitted for ethoprop; the granular labels instead need to state:

             "Aerial applications not permitted for this product."

       In addition, the Agency had previously determined that a "no-spray zone" (buffer zone
adjacent to surface waters) is necessary for the EC formulation, due to both the toxicity of
ethoprop to aquatic organisms, and the potential mobility of this formulation. When the Draft
PR Notice 2001-X is finalized, the label statement may need to be amended. However, hi the
interim, the EC formulation end-use product needs to include the following no-spray zone
statement (see Table 14):

             "Do not apply this product withinl40 feet inland of freshwater habitats, and along
             the Atlantic seaboard, do not apply within 800 feet of brackish water habitats.
             Under no  circumstances is this product to be applied within 140 feet of people or
             these surface water bodies."
                                           74

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V. What Registrants Need to Do

       In order to be eligible for reregistration, registrants need to implement the risk mitigation
measures outlined in Sections IV and V, which include, among other things, submission of the
following:

       For ethoprop technical grade active ingredient products, technical registrants need to
submit the following items:

             Within 90 days from receipt of the generic data call-in (DCI):

             (1)    completed response forms to the generic DCI (i.e., DCI response form and
                    requirements status and technical registrant's response form); and
             (2)    any time extension and/or waiver requests with a full written justification..

             Within the time limit specified in the generic DCI:

             (1)    cite any existing generic data which address data requirements or submit
                    new generic data responding to the DCI.

       For questions about generic reregistration or the DCI, please contact Anthony Britten at
703-308-8179. Address all materials you submit in response to the DCI as follows:
By US mail:
Document Processing Desk
Anthony Britten
USEPA(7508C)
1200 Pennsylvania Ave., NW
Washington, DC  20460
Or by express or courier service only:
Document Processing Desk
Anthony Britten
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
      For products containing the active ingredient ethoprop. registrants need to submit the
following items for each product:

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

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

             (2)    any time extension or waiver requests with a full written justification.
                                         75

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            Within eight months from the receipt of the PDCI:

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

            (2)    a completed original application for registration (EPA Form 8570-1)
                   and indicate on the form that it is an "application for reregjstration";

            (3)    five copies of the draft label incorporating all label amendments outlined
                   in Table 14 of this document;

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

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

            (6)    the product-specific data responding to the PDCI.

      For questions about product reregistration or the PDCI, please contact Karen E. Jones at
703-308-9047.  Address all materials you submit in response to the PDCI as follows:
Bv US mail:
Document Processing Desk
Karen E. Jones
USEPA(7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
Or bv express or courier service only:
Document Processing Desk
Karen E. Jones
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA  22202
       A. Manufacturing-Use Products

             1. Additional Generic Data Requirements

       The generic data base supporting the reregistration of ethoprop for the above eligible uses
has been reviewed and determined to be substantially complete, except for the following
additional required confirmatory data. The required studies are listed by their new OPPTS
guideline numbers. Old guideline numbers, if applicable, are in parentheses.

      OPPTS 830.7050 - UV/Visible absorption with technical grade active ingredient

      OPPTS 835.7100 - Drinking water monitoring from ground water sources

      OPPTS 835.7200 - Drinking water monitoring from surface waiter sources

      OPPTS 850.1500 - Full fish life cycle testing with marine/estuarine fish (72-5b)
                                         76

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                 [and full life cycle testing with freshwater fish is reserved (72-5a), pending outcome of
                 testing with marine/estuarine fish]

                OPPTS 850.2300 - Avian reproduction testing with the northern bobwhite quail (71-4a)
                 [and avian reproduction testing with the mallard duck is reserved (71-4b), pending
                 outcome of testing with bobwhite quail]

                OPPTS 860.1340 - Residue analytical method (171-4c)

                 OPPTS 860.1380 - Storage stability data (171-4e)

                OPPTS 860.1500 - Crop field trials; beans, cabbage and potatoes (171-4k)

                OPPTS 870.3465 - 90-day inhalation toxicity study [this study is reserved pending
                 review of the Perceived Dust data] (82-4)

                OPPTS 870.6100 - Acute and 28-day delayed neurotoxicity of organophosphorus
                 substances [in hen] (81-7)

                OPPTS 870.6300 - Developmental neurotoxicity study (83-6)

                OPPTS 875.1350-SS, Special Study - Information concerning the granular formulations,
                 including properties of cellulose-based granules themselves; the physical properties of
                 cellulose-based ethoprop granules; methods to collect and analyze the very small dust
                 particles released; determinations of whether these small particles contain ethoprop or are
                 just fractionated cellulose; and additional information on the Perceived Dust method
                 (including quality control data)

                OPPTS 875.1500 - Worker biological monitoring with the EC formulation

                OPPTS 875.2800- Description of human activity for post-application

                 The above studies are confirmatory data. If the Agency finds that the results of these
          studies do not confirm the Agency's expectations, or provide information which identify
          additional risks of concern, the Agency will reconsider the measures established in this IKED.

                 Also, a DCI notice was issued on September 10,1999 to all registrants of OP pesticides
          currently registered under FIFRA (64 FR 42945-42947, August 6,1999, and 64 FR 44922-
          44923, August 18,1999), including Rhone-Poulenc Ag Company (the corporate predecessor of
          the technical registrant, Aventis CropScience). The DCI  requirements included acute,
          subchronic, and developmental neurotoxicity (DNT) studies. In response, Aventis cited studies
          for acute and subchronic neurotoxicity in the rat, and for the DNT data requirement, Aventis
          submitted a protocol for Agency review. The Agency sent a response letter to Aventis on May
          30,2001 concerning the cited studies and the protocol for these neurotoxicity study requirements.
          In the letter, the Agency indicated that the acute and subchronic neurotoxicity studies for
          ethoprop were supplementary, but upgradable to meet the current data requirements; however,
          data have not yet been submitted. Concerning the requirement for DNT data, Aventis (as well as
                                                    77
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other registrants) have not yet submitted a study report. In addition, the Agency had previously
determined that additional neurotoxic esterase (NTE) testing is required for the ethoprop MED,
based on results of existing neurotoxicological testing, and has listed this data requirement as
confirmatory.

             2. Labeling for Manufacturing-Use Products

       To remain in compliance with FIFRA, manufacturing use product (MUP) labeling should
be revised to comply with all current EPA regulations, PR Notices, and applicable policies.  The
MUP labeling must bear the labeling contained in Table 14 at the end of this section.

       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 reregistration eligibility has 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 the study MRJD numbers should
be cited according to the instructions in the Requirement Status and Registrants Response Form
provided for each product.
IKED.
       A product-specific data call-in, outlining specific data requirements, accompanies this
             2. Labeling for End-Use Products
       Labeling changes are necessary to implement the mitigation measures outlined in Section
IV above. Specific language to incorporate these changes is specified in the Table 14 at the end
of this section.

       C. Existing Stocks

       Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Interim Reregistration Eligibility Decision
document. Persons other than the registrant may generally distribute or sell such products for 50
months from the date of the issuance of this IRED. However, existing stocks time frames will be
established case-by-case, depending on the number of products involved, the number of label
changes, and other factors. Refer to "Existing Stocks of Pesticide Products; Statement of
Policy"; Federal Register. Volume 56, No. 123, June 26,1991.

       The Agency has determined that the registrant may distribute and sell ethoprop products
bearing old labels/labeling for 26 months from the date of issuance of this IRED.  Persons other
than the registrant may .distribute or sell such products for 50 months from the date of the
issuance of this IRED. Registrants and persons other than the registrant remain obligated to meet
                                          78

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pre-existing Agency imposed label changes and existing stocks requirements applicable to
products they sell or distribute.

      D. Labeling Changes Summary Table

      A summary of the required label changes for ethoprop is shown in Table 14.
                                          79

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VI. APPENDICES

       This section includes Appendices that provide a listing of all related documents and how to
access them, a data call-in (DCI), and other information.

       All documents supporting the ethoprop IRED, in hard copy form, may be viewed in the OPP
Public Regulatory Docket room or downloaded or viewed via the Internet at the following site:
"http://www.epa.gov/pesticides/op". The OPP Public Docket is located in Room. 119, Crystal Mall
#2,1921 Jefferson Davis Highway, Arlington, VA. It is open Monday through Friday, excluding
legal holidays, from 8:30 am to 4 pm.
                                          93

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-------
Appendix B.        Generic Data Requirements and Studies Utilized to Make the IRED for
                    Ethoprop

GUIDE TO APPENDIX B
      Appendix B contains a listing of data requirements which support the IRED for the active
ingredient within Case #0106 (ethoprop). It contains generic data requirements that apply to
Ethoprop in all products, including data requirements for which a "typical formulation" is the test
substance. The data table is organized as follows:
       1.
      2.
Data Requirement (Columns 1 to 3). The data requirements are listed in the
general order in which they appear in 40 CER part 158, with new OPPTS
Guideline Numbers (GLNs) in column 1 and old GLNs in column 2.  The
name of each GLN Data Requirement is listed in column 3.  The GLNs also
refer to the Pesticide Assessment Guidance test protocols, which are available
from the National Technical Information Service, 5285 Port Royal Road,
Springfield, VA 22161, (703) 487-4650.

Use Pattern (Column 4). This column indicates the use patterns for which
each data requirement applies. The following letter designations are used for
the use patterns:

ATerrestrial 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
LGreenhouse non-food
J.Forestry
K.Residential
LJndoor food
M.Indoor non-food
N.Indoor medical
CXIndoor residential
      3.
Bibliographic Citation (Column 5).  If the Agency has acceptable data in its
files, this column lists the identity number for each study, usually the Master
Record Identification (MRID) number.  Refer to the Bibliography in
Appendix D for a complete citation of the study.
                                          99

-------
Table of Data Supporting the Guideline Requirements for the IRED for Ethoprop
PRODUCT CHEMISTRY
New
Guideline
Number
830.1550
830.1600
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7050
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
830.7550
830.7000
830.6313
830.6314
830.6315
830.6316
830.6317
830.7100
830.6319
830.6320
(Old
Guideline
Number)
(61-1)
(61-2(a))
(61-2(b))
(62-1)
(62-2)
(62-3)
(63-2)
(63-3)
(63-4)
None
(63-5)
(63-6)
(63-7)
(63-8)
(63-9)
(63-10)
(63-11)
(63-12)
(63-13)
(63-14)
(63-15)
(63-16)
(63-17)
(63-18)
(63-19)
(63-20)
Requirement
Product Identity and Composition
Starting Materials and Manufacturing
Processes
Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
Odor
UV/Visible Absorption
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition Coefficient
PH
Stability-
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
Use
Pattern
All
All
All
All
All
An
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
Cltation(s)
(MRID)
00152115, 410044-01, 413044-01,
452063-01,453885-04
410044-01
00152115,410044-01
00152115,412112-03
00152115,412112-03
00152115,412112-03
410553-01,429535-01
410553-01
410553-01
Data Gap
Not Applicable: Ethoprop is a liquid
at room temperature.
410553-01
00142272
00142272
00142272
Waived: Ethoprop does not contain
any ionizable functional groups, and
does not dissociate in water.
00142272
00142272
410553-01
00142272 >
00142272
00142272,00152115
420448-01
00142272
00142272, 410553-01
00142272
                                       100

-------
New
Guideline
Number
(Old
Guideline
Number)
Requirement
Use
Pattern
atation(s)
(MRID)
ECOLOGICAL EFFECTS
850.2100
850.2200
850.2200
850.2400
850.2300
850.2300
850.2500
850.1075
850.1075
850.1010
850.1075
850.1025
850.1035
850.1045
850.1400
850.1300
850.1350
850.1500
850.1500
850 3020
(71-1)
(71-2(a))
(71-2(b))
(71-3)
(71-4(a))
(71-4(b))
(71-5)
(72-l(a))
(72-l(b))
(72-2)
(72-3(a))
(72-3(bl))
(72-3(b2))
(72-3(b3))
(72-4(a))
(72-4(b))
(72-4(c))
(72-5(a))
(72-5(b))
(141-1)
Avian Acute Oral Toxicity (LDJO)
Avian Dietary Toxicity (LC^,) - Quail
Avian Dietary Toxicity (LC
-------
New
Guideline
Number
850.5400
(Old
Guideline
Number)
(122-2)
Requirement
Aquatic Plant Growth
Use
Pattern
A,B,C
Citation(s)
(MRTO)
402284-01
TOXICOLOGY
870.1100
870.1200
870.1200
870.1300
870.2400
870.2500
870.2600
870.6100
870.6200
870.6300
870.3100
870.3150
870.3200
870.3200
870.3465
870.6200
870.4100
870.4100
870.4100
870.4200
870.4200
870.3700
870.3700
870.3800
870.4300
870.5140
(81-1)
(81-2)
(81-2)
(81-3)
(81-4)
(81-5)
(81-6)
(81-7)
(81-8)
(83-6)
(82-l(a))
(82-l(b))
(82-2)
(82-2)
(82-4)
(82-7)
(83-l(a))
(83-l(a))
(83-l(b))
(83-2(a))
(83-2(a))
(83-3fa))
(83-3(b))
(83-4)
(83-5)
(84-2(a))
Acute Oral Toxicity - Rat
Acute Dermal Toxicity - Rabbit
Acute Dermal Toxicity - Rat
Acute Inhalation Toxicity - Rat
.Primary Eye Irritation - Rabbit
Primary Skin Irritation - Rabbit
Dermal Sensitization
Acute Delayed Neurotoxicity - Hen
Acute Neurotoxicity Screen - Rat
Developmental Neurotoxicity
90-Day Feeding - Rodent
90-Day Feeding - Dog
21-Day Dermal - Rabbit
21-Day Dermal - Rat
90-Day Inhalation - Rat
Subchronic Neurotoxicity - Rat
Chronic Feeding Toxicity - Rat
Chronic Feeding Toxicity - Mouse
Chronic Feeding Toxicity - Dog
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Combined Chronic Toxicity/
Carcinogenicity - Rat
Gene Mutation (Ames Test)
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
00078035, 444725-01
00078035,429795-02
429795-01
00128218
00078036
00048774
Waived due to high acute dermal
toxicity of technical ethoprop
406094-01(partially satisfies);
Data Gap: Neurotoxic Esterase test
434424-02, 431977-01, 441 140--0,
449895-01
Data Gap; DCI on 9/10/99 for all OPs
425302-01
00075240
413044-04, 450348-01
450746-01, 450746-02
Data Gap (Reserved pending analyses
of dust associated with granular
formulations, and refinements of
inhalation exposure estimates)
434424-01
00138636, 402918-01, 425302-01
40356301, 433260-01
00160179, 414986-01
402918-01, 425301-01
403563-01, 433260-01
413044-02
413044-03
419212-01
00138636, 402918-01, 425302-01
00160180, 00160181, 440650-01
102

-------
New
Guideline
Number
870.5375
870.5550
870.5900
870.7485
(Old
Guideline
Number)
(84-2(b))
(84-4)
(84-4)
(85-1)
Requirement
Structural Chromosomal Aberration
Other Genotoxic Effects - Unscheduled
DNA Synthesis in Mammalian Cells in
Culture
Other Genotoxic Effects - In Vitro Sister
Chromatid Exchange
General Metabolism
Use
Pattern
All
All
All
All
Citation(s)
(MRID)
00160183, 403869-01, 412112-02
00160182,440387-02
00160184
418043-01
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2400
875.2500
875.2400
875.2400
875.1500
875.1350
SS
875.2800

835.2120
835.2240
835.2410
835.4100
835.4200
835.4300
835.1240
835.1410
835.6100
860.1850
860.1900
None
835.7100
(133-3)
(133-4)
(133-3)
(133-3)



Dermal Passive Dosimetry Exposure
Inhalation Passive Dosimetry Exposure
Transferable Turf Residue
Granular Handler Exposure
Worker Biomonitoring with the EC
Formulation
Information Concerning the Granular
Formulations
Description of Human Activities for
Post-Application
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
ENVIRONMENTAL FATE
(161-1)
(161-2)
(161-3)
(162-1)
(162-2)
(162-4)
(163-1)
(163-2)
(164-1)
(165-1)
(165-2)
(165-4)
(166-1)
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Aerobic Aquatic Metabolism
Leaching/Adsorption/Desorption
Laboratory Volatility
Terrestrial Field Dissipation
Confined Rotational Crop
Field Rotational Crop
Bioaccumulation in Fish
Ground Water Monitorine Studv
All
All
All
All
All
All
All
All
All
All
All
All
All
449841-01, 451131-02, 451672-01,
452507-02
449841-01,451131-02,451672-01,
452507-02
449722-01,449722-03
449722-01,449722 -06, 449722-07
Data Gap
438525-01, 450797-06, 452063-01,
452063-02, 453885-04, 453885-05
(partially satisfies);
Data Gap
Data Gap

412707-03
412707-02, 438335-02
412707-04,438335-01
00160171
00160171
449895-02
437786-01
412112-01
417124-01,443980-01
421976-01
443502-01
414256-01, 414256-02, 430384-01,
430384-02
Data Gao
103

-------
New
Guideline
Number
835.7200
(Old
Guideline
Number)

Requirement
Surface Water Monitoring Study
Use
Pattern
All
Citation(s)
(MRID)
Data Gap
RESIDUE CHEMISTRY
860.1300
860.1300
860.1340
860.1360
860.1380
860.1480
860-1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
(17M(a))
(171-4(b))
(171-4(c))
(171-4(m)
(171-4{e))
(171-40)
(171-4(k))
(171-4(k))
(171-4(k))
(171-4(k))
f!71-4(k))
(171-4(k))
(171-4(k))
(171-4(k))
(171-4(k))
C171-4(k))
(171-4(k))
Nature of Residue - Plants
Nature of Residue - Livestock
Residue Analytical Method - Plants
Multiresidue Method
Storage Stability
Magnitude of Residues - Meat, Milk,
Poultry, and Egg
A,B,C
A,B,C
A,B,C
A,B,C
A,B
A,B,C
00040380, 00075252, 00075253,
00075354, 00075255, 00075256,
00092103, 406532-05, 416910-01,
418140-01, 418408-01, 419460-01,
438364-01,438687-01
00092070, 429232-01, 429627-01,
432090-01
00075245, 00075246, 00092079,
00092080, 00125395, 00125397,
00129928, 00145970, 00153065,
00153326, 00154203, 00160441,
422206-01, 432775-02, 433736-01,
443215-01;
Data Gap
412707-01,422421-01
00160441, 435394-01, 439715-01;
Data Gap
00092101
Magnitude of Residue in Crop Plants - Crop Field Trials
Crop Field Trials (Potatoes)
Crop Field Trials (Sweet Potatoes)
Crop Field Trials (Cabbage)
Crop Field Trials (Beans, Lima)
Crop Field Trials (Beans, Snap)
Crop Field Trials (Soybeans)
Crop Field Trials (Lima and Snap,
Forage)
Crop Field Trials (Soybean, Forage and
Hay)
Crop Field Trials (Cucumbers)
Crop Field Trials (Corn, Fresh (inc.
Sweet) (K+CWHR))
A
A
A
A
A
A
A
B
A
A
00153065, 400285-02;
Data Gap
00075252
00092068, 00125397, 435832-01;
Data Gap
406532-04, 435396-01
406532-04,435386-01;
Data Gap
00076720, 00092072, 00092074
406532-04
00076720,406532-01
406532-04,434840-01
00075249, 00075250, 00092108',
00092109, 00092135, 406532-07,
434910-01.437482-03
104

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New
Guideline
Number
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1520
860.1520
860.1520
860.1520
860.1520
860.1520
860.1520
810.1000
860.1850
860.1900
(Old
Guideline
Number)
(171-4(k:))
(171-4(k
(171-4(k))
(171-400)
(171-4(fc))
(171-4(k))
(171-400)
(171-400)
(171-400)
(171-400)
(171-400)
(171-400)
(171-40))
(171-40))
(171-40))
(171-40))
(171-4(1))
(171-40))
(171-4(1))
90-1
(165-1)
H65-2)
Requirement
Crop Field Trials (Corn, Grain (inc.
pop))
Crop Field Trials (Com, Forage and
Fodder)
Crop Field Trials (Banana)
Crop Field Trials (Mushrooms)
Crop Field Trials (Okra)
Crop Field Trials (Peanut)
Crop Field Trials OPeanut Hay)
Crop Field Trials OPineapple)
Crop Field Trials (Pineapple, Fodder
and Forage)
Crop Field Trials (Sugarcane)
Crop Field Trials (Sugarcane, Fodder
and Forage)
Crop Field Trials (Tobacco)
Use
Pattern
A
B
A
A
A
A
B
A
B
A
B
C
Citation(s)
(MRID)
00075249, 00075250, 00092108,
00092109, 00092135, 406532-07,
435309-01,437482-01
00075249, 00075250, 00092108,
00092109, 00092135, 406532-07,
435309-01
406532-06
00030481, 00030482
00125395
00092106, 00092116, 00129928,
00141494, 406532-02, 435397-01,
440624-01
00092106, 000921 16, 00129928,
00141494, 406532-02, 435397-01,
440624-01
00092070, 00154203, 429016-01
00092070, 00154203
406532-03
406532-03
00145970, 00153065, 418096-01
Magnitude of Residues in Processed Food/Feed
Processed Food (Corn)
Processed Food ffeanut)
Processed Food flMneapple)
Processed Food OPotato)
Processed Food (Soybean)
Processed Food (Sugarcane)
Use/Usage Data
Confined Accumulation in Rotational
Crops
Field Accumulation in Rotational Crops "
A
A
A
A
A
A
A.B, C
A,B
A.B
437482-02
435398-01, 440033-Or
429455-01
433736-01
Uses have been deleted from label
432775-01, 439715-01
449702-01 452859-01
421976-01
443502-01
105

-------
106

-------
Appendix C.
Technical Support Documents Utilized to Make the ERED for Ethoprop
      Additional documentation in support of this IRED is maintained in the OPP docket, located
in Room 119, Crystal Mall #2,1921 Jefferson Davis Highway, Arlington, VA. It is open Monday
through Friday, excluding legal holidays, from 8:30 am to 4 pm.

      The docket initially contained preliminary human health risk assessment and related
documents as of May 21,1998, and the preliminary environmental risk assessment as of October 5,
1998. Sixty days after each of these documents became available, the first public comment periods
closed. The EPA then considered comments, revised the risk assessments, and added the formal
"Response to Comments" document and the revised risk assessments to the docket on September 2,
1999.

      All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the Internet at the following site:

                   www.epa.gov/pesticides/op

These documents include:

      Human Health and Effects Documents:

1.    Ethoprop - Report of the Cancer Assessment Review Committee. (Jess Rowland, October 2,
       1997)
2.    Ethoprop - FQPA Requirement - Report of the Hazard Identification Assessment Review
      Committee. (Jess Rowland, November 10,1997)
3.    Memorandum. HED Metabolism Committee Meeting on 1/27/98. (Kit Farwell, February 6,
       1998)
4.    Review of Ethoprop Incident Reports. (Jerome Blondell and Monica F. Spann, March 9,
       1998)
5.    Ethoprop, Product and Residue Chemistry Chapters for the Reregistration Eligibility
      Decision. (John Abbots, March 27,1998)
6.    Occupational and Residential Exposure Assessment and Recommendations for the
      Reregistration Eligibility Decision Document for Ethoprop. (Kathryn Boyle, April 2,1998)
7.    Toxicology Chapter for the Reregistration Eligibility Document for Ethoprop. (Kit Farwell,
      April 17,1998)
8.    Ethoprop. Anticipated Residues for Acute and Chronic Non-Cancer Dietary Exposure.
      (Sheila Piper, April 23,1998)
9.    Ethoprop. Anticipated Residues for Chronic (Cancer) Dietary Exposure. (Sheila Piper, April
      29,1998)
10.    Ethoprop. Acute and Chronic Dietary Risk Analyses for the HED RED Chapter. (Christina
      Swartz, May 5,1998)
                                          107

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 11.    Organophosphate Pesticides: Ethoprop Human Health Risk Assessment. (Kit Farwell, May
       21,1998)
 12.    Memo. HED Hazard Identification Assessment Review Committee. (Jess Rowland, June 3,
       1998)
 13.    Ethoprop Revised Human Health Risk Assessment, Attachment 3. Addendum to Toxicology
       Chapter. Selection of Inhalation Endpoints. Assessment by the Hazard Identification
       Assessment Review Committee and the FQPA Safety Factor Committee. (Kit Farwell,
       August 31,1998)
 14.    Ethoprop Revised Human Health Risk Assessment, Attachment 4. Response to the USDA
       Comments to the EPA's Monte Carlo Dietary Exposure estimate for Ethoprop and Further
       Refinements. (Sheila Piper, July 12,1999)
 15.    Ethoprop Revised Human Health Risk Assessment, Attachments. Revised Chronic Dietary
       Exposure Analyses for the HED Risk Assessment. (Christina Swartz, July 21,1999)
 16.    Ethoprop Revised Human Health Risk Assessment, Attachment 6. Revised
       Occupational/Non-Occupational/Residential Exposure Assessment for the Reregistration
       Eligibility Decision. (Catherine Bodurow Joseph, September 2,1999)
 17.    Ethoprop Revised Human Health Risk Assessment.  (Kit Farwell, September 2,1999)
 18.    Ethoprop - Revised Report of the Hazard Identification Assessment Review Committee. (Kit
       Farwell, May 15,2000)
 19.    Ethoprop: Revised Occupational/Non-Occupational/Residential Exposure Assessment For
       Reregistration Eligibility Decision (RED) Document. (Jeffrey Dawson, May 18,2000)
20.    Ethoprop - Review of aldicarb (Temik 10G) granular backpack mixer/loader/applicator study
       (MRDD 451672-01) in bananas as a source of surrogate data for ethoprop exposure and
       assessment (Jeffrey Dawson, October 17,2000)
21.    Ethoprop - Review of fipronil granular mixer/loader/applicator study (MRID 452501-01) in
       bananas as a source of surrogate data and accompanying ethoprop risk assessment. (Jeffrey
       Dawson, January 5,2001)

       Environmental Fate and Effects Documents:

1.     Ethoprop Tier H EECs. (Sid Abel, May 26,1998)
2.     Environmental Fate and Effects Division RED Chapter for Ethoprop.  (Sid Abel, N.E.
       Federoff, Dana Spatz, Ann Stavola, October 5,1998)
3.     Errata Sheets.  (November 18,1998; February 18,1999; August 30,1999)
4.     Review of Aerobic Aquatic Metabolism study (162-4) and updated tier II drinking water
       EECs for Ethoprop for use in the human health risk assessment.  (Dana S. Spatz  and Dirk F.
       Young, April 24,2000)
5.     Revised'ethoprop drinking water assessment.  (Jim Cowles, March 26,2001)
1.
Risk Management Documents:

Memorandum.  Notes on Ethoprop SMART Meeting on 10/30/97. (Judy Loranger, October
31,1997)
                                          108

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2.     Overview of Revised Ethoprop Risk Assessment - prepared for Technical Briefing. (Kathryn
       Boyle, September 2,1999)
3.     Response to Comments on Preliminary Risk Assessment for the Organophosphate Ethoprop.
       (Kathryn Boyle, September 2,1999)

       Biological and Economic Analysis Documents

1.     EPA's Quantitative Usage Analysis. (John Faulkner, August 1, 1998, revised February 2,
       1999)
2.     Specific Request Concerning Ethoprop. (John L. Faulkner and William L. Gross, Jr., April
       6,2000)
3.     Review of National Potato Council's Response to EPA Questions Regarding Ethoprop.
       (John L. Faulkner and William L. Gross, Jr., July 5,2000)
                                          109

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110

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Appendix D.
Citations Supporting the IKED for Ethoprop (Bibliography)
GUIDE TO APPENDIX D

1.     CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
       considered relevant by the Agency in arriving at the positions and conclusions stated
       elsewhere in the Interim Reregistration Eligibility Decision (IRED) document. Primary
       sources for studies in this bibliography have been the body of data submitted to the Agency
       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.
       IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically
       by Master Record Identifier, or "MRID," number. This number is unique to the citation, and
       should be used whenever a specific reference is required. It is not related to the six-digit
       "Accession Number" which has been used to identify volumes of submitted studies (see
       paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
       bibliography late in the review may be preceded by a nine character temporary identifier.
       These entries are listed after all MRID entries.  This temporary identifying number is also to
       be used whenever specific reference is needed.

       FORM OF ENTRY. In addition to the MRID, each entry consists of a citation containing
       standard elements followed, in the case of material submitted to the Agency, by a description
       of the earliest known submission.  Bibliographic conventions used reflect the standard of the
       American National Standards Institute (ANSI), expanded to provide for certain special
       needs.
       a.
Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
      b.
Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained hi the document. When the date appears

                       111

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c.
as (19??), the Agency was unable to determine or estimate the date of the
document.

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.

Trailing parentheses. For studies submitted to the Agency hi the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:

(l)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.
                                    112

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     MRID#
CTTATION
 00022923
  Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary Toxicities of
  Environmental Pollutants to Birds: Special Scientific ReportWildlife No.
  191. (U.S. Dept. of the Interior, Fish and Wildlife Service, Patuxent Wildlife
  Research Center; unpublished report)
00030481
  Snetsinger, R.; Kanuk, MJ. (1979) Ethoprop Residue Tolerance Petition-
  Mushrooms: Summary. (Unpublished study including PR No. 908 and
  Laboratory No. 6E-2554, received Mar 27,1980 under OE2341; prepared by
  New York State Agricultural Experiment Station, Northeast Regional
  Pesticide Laboratory and Cannon Laboratories, Inc., submitted by
  Interregional Research Project No. 4, New Brunswick, N.J.; CDL:099351-A)
00030482
  Snetsinger, R.; Chung, S.L.; Kielbasa, R.; et al. (1979) Ethoprop: Sciarid Fly
  Control in Mushrooms. (Unpublished study including PR No. 908 and
  published data, received Mar 27,1980 under OE2341; prepared in
  cooperation with Pennsylvania State Univ., Dept of Entomology, submitted
  by Interregional Research Project No. 4, New Brunswick, N.J.;
  CDL:099351-C)
00040380
  Menzer, R.E.; Iqbal, Z.M.; Boyd, G.R. (1971) Metabolism of O-Ethyl S,S-
  dipropyl phosphorodithioate (Mocap) in bean and corn plants. Journal of
  Agricultural and Food Chemistry 19(2):351-356. (Also in unpublished
  submission received Sep 2,1971 under 2F1204; submitted by Mobil Chemical
  Co., Richmond, Va,; CDL:094057-D)
00048774
  Becker, J. Parke, G.S.E. (1977) Report: A Primary Dermal Irritation Study of
  Ethoprop 93% Technical Grade on Abraded and Nonabraded Skin of New
  Zealand Albino Rabbits: Laboratory No. 7E-6084. (Unpublished study
  received July 15,1977 under 2224-43; prepared by Cannon Laboratories, Inc.,
  submitted by Mobil Chemical Co., Industrial Chemicals Div., Richmond, Va.;
  CDL:230885-C)
00048779
 Vilkas, A.G. (1977) Acute Toxicity of Mocap to the Grass Shrimp,
 Palaemonetes pugio. and Fiddler Crab, Uca pugilator: UCES Project #
 11506-05-04. (Unpublished study received Jul 15,1977 under 2224-43;
 prepared by Union Carbide Corp., submitted by Mobil Chemical Co.,
 Industrial Chemicals Div., Richmond, Va.; CDL:230885-H)
                                          113

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    MRID#     CITATION
00066341
00043714
00068325
00066220
00075239
00075240
00075245
00075246
U.S. Environmental Protection Agency, Environmental Research Laboratory
(1981) Acephate, Aldicarb, Carbophenothion, DBF, EPN, Ethoprop, Methyl
Parathion, and Phorate: Their Acute and Chronic Toxicity, Bioconcentration
Potential, and Persistence as Related to Marine Environments:
EPA-600/4-81-023. (Unpublished study)

Atkins, E.; Kellum, D.; Neuman, K.; et al. (1975) Effect of Pesticides on
Apiculture: Project No. 1499.1975 annual rept (Unpublished study received
Mar 8,1976 under 201-EX-50; prepared by Univ. of California-Riverside,
Citrus Research Center and Agricultural Experiment Station, Dept. of
Entomology, submitted by Shell Chemical Co., Washington, DC;
CDL:095407-U) (Study is duplicate of MRID# 00111934)

Vilkas, A.G. (1977) Acute Toxicity of Ethoprop to the Water Flea, Daphnia
mapna Straus: UCES Proj. # 1506-05-03. (Unpublished study received Aug
16,1977 under 2224-44; prepared by Union Carbide Corp., submitted by
Mobil Chemical Co., Industrial Chemicals Div., Richmond, Va.;
CDL:231370-B)   ,

Atkins, E.; Anderson, L.; Kellum, D.; et al. (1977) Protecting Honey Bees
from Pesticides. Riverside, CA: Univ. of California. (Leaflet 2883; also In
unpublished submission received Nov 2; 1983 under 239-2507; submitted by
Chevron Chemical Co., Richmond, CA; CDL:251760-B) (Study is duplicate
of MRID# 00132710)

Weir, RJ. (1967) Final Report: Three-month Dietary AdministrationRats:
Project No. 230-102. (Unpublished study received Nov 25,1968 under
9F0750; prepared by Hazleton Laboratories, Inc., submitted by Mobil
Chemical Co., Industrial Chemicals Div., Richmond, Va.; CDL:091296-C)

Weir, R.J.; Rundzins, W. (1967) Final Report: 13-week Dietary
Administration  Dogs: Project No. 230^-110. (Unpublished study received
Nov 25,1968 under 9F0750; prepared by Hazleton Laboratories, Inc.,
submitted by Mobil Chemical Co., Industrial Chemicals Div., Richmond, Va.;
CDL:091296-D)

Mobil Chemical Company (19??) The Determination of Residues of Mocap
on Corn Products.  Undated method. (Unpublished study received Nov 25,
1968 under 9F0750; CDL:091296-J)

Mobil Chemical Company (19??) Analysis of Fortified Samples.
(Unpublished study received Nov 25,1968 under 9F0750; CDL:091296-K)

                       114

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    MRID#
CITATION
00075249    -
  Mobil Chemical Company (1966) SummaryResults of Com Sample
  Analyses for Mocap Residues. (Compilation; unpublished study received Nov
  25,1968 under 9F0750; CDL:091296-N)
00075250
  Boyd, G.R. (1968) Residues of Mocap in Corn Plants Treated at Exaggerated
  Rates: Project No. 532. (Unpublished study received Nov 25,1968 under
  9F0750; submitted by Mobil Chemical Co., Industrial Chemicals Div.,
  Richmond, Va.; CDL:091296-O)
00075252
  DuVal, A.F.; Boyd, G.R. (1967) The Persistence of Mocap in Treated Soil:
  RN 67-3. (Unpublished study received Nov 25,1968 under9F0750; submitted
  by Mobil Chemical Co., Industrial Chemicals Div., Richmond, Va.;
  CDL:091296-Q)
00075253
  Menzer, R.E. (1967) Uptake and Metabolism of Mocap by Plants.
  (Unpublished study received Nov 25,1968 under 9F0750; prepared by Univ.
  of Maryland, Dept. of Entomology, submitted by Mobil Chemical Co.,
  Industrial Chemical Div., Richmond, Va.; CDI/.091296-R)
00075254
  Menzer, R.E.; Iqbal, M.Z. (1968) Metabolism of Mocap in Beans and Corn.
  (Unpublished study received Nov 25,1968 under 9F0750; prepared by Univ.
  of Maryland, Dept of Entomology, submitted by Mobil Chemical Co.,
  Industrial Chemicals Div., Richmond, Va.; CDL:091296-S)
00075255
  Mobil Chemical Company (19??) Gas Chromatography of Mocap Metabolites
  Formed hi Bean Plants and Isolated by Column Chromatography.
  (Unpublished study received Nov 25,1968 under 9F0750; CDL:091296-T)
00075256
  Mobil Chemical Company (19??) Chemical Studies on the Metabolism of
  Mocap in Bean Plants. (Unpublished study received Nov 25,1968 under
  9F0750; CDL:091296-U)
00076720
  Mobil Chemical Company (1980) [Residue of Mocap EC on Peanuts,
  Soybeans and Other Crops]. (Compilation; unpublished study received Mar
  19,1981 under 2224-44; CDL:244800-A)
00078035
  Powers, M.B. (1965) Acute Oral AdministrationRats; Acute Dermal
  ApplicationRabbits. (Unpublished study received Nov 25,1968 under
  9F0750; prepared by Hazleton Laboratories, Inc., submitted by Mobil
  Chemical Co., Macedon, N.Y.; CDL:091295-C)
                                        115

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    MRTO#
CITATION
00078036
  Weir, RJ. (1965) Acute Eye ApplicationRabbits. (Unpublished study
  received Nov 25,1968 under 9F0750; prepared by Hazleton Laboratories,
  Inc., submitted by Mobil Chemical Co., Macedon, N.Y.; CDL:091295-D)
00078038
00078042
00092068
00092070
00092072
00092074
  Weir, RJ.; Clark, O. (1966) Acute Oral LD50 - Hens: Project No. 230-108.
  (Unpublished study received Nov 25,1968 under 9F0750; prepared by
  Hazleton Laboratories, Inc., submitted by Mobil Chemical Co., Macedon,
  N.Y.; CDL:091295-F)

  Weir, RJ. (1967) Final Report: Acute Aqueous ExposureGoldfish, Bluegill,
  and Rainbow Trout: Project No. 230-111. (Unpublished study received Nov
  25,1968 under 9F0750; prepared by Hazleton Laboratories, Inc., submitted
  by Mobil Chemical Co., Macedon, N.Y.; CDL:091295-J)

  Mobil Chemical Company (1971) SummaryCole Crop Residue Analysis.
  (Unpublished study received Sep 10,1972 under 2F1250; CDL:091781-A)

  Mobil Chemical Company (1969) Mocap Residues in Pineapples.
  (Unpublished study received on unknown date under OF0959; CDL:091636-
  B)

  Mobil Chemical Company (1969) (Residue Study of Mocap on Soybeans).
  (Compilation; unpublished study received Apr 11,1970 under OF0872;
  CDL:091505-B)

  Downing, C.R. (1969) Effects of Excess Mocap (Prophos) Rates on Soybeans:
  Project No. 253. (Unpublished study received Apr 11,1970 under OF0872;
  submitted by Mobay Chemical Co., Ashland, Va.; CDL:091505-D)
00092079
  Mobil Chemical Company (19??) The Determination of Residues of Mocap in
  Animal Tissues. Undated method. (Unpublished study received Apr 24,1967
  under 9F0750; CDL:093062-E)
00092080
  Mobil Chemical Company (1969) The Determination of Residues of Prophos
  in Plant Materials. Method R-89-A dated Oct 7,1969. (Unpublished study
  received on unknown date under OF0872; CDL: 093170-A)
00092101
  Holsing, G.C. (1968) Final Report: 21-day Oral Administration - Dogs:
  Project No. 230-124. (Unpublished study received Jan 20,1970 under
  OF0872; prepared by Hazleton Laboratories, Inc., submitted by Mobil
  Chemical Co., Ashland, Va.; CDL:094845-A)
                                         116

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    MRLD#
CTTATION
00092103
  Mobil Chemical Company (1968) The Fate of Mocap in Soil and Plants.
  (Unpublished study received on unknown date under 9F0750;
   CDL:098645-D)
00092106
  Mobil Chemical Company (1972) [Residue Study of Mocap on Peanuts].
  Includes method R-89-A dated Oct 7,1969. (Compilation; unpublished study
  received Apr 14,1972 under 2224-37; CDL:119790-A)
00092108
  Mobil Chemical Company (1972) Summary of Residue Analyses: [Mocap].
  Includes method R-89-A dated Oct 7,1969. (Compilation; unpublished study
  received Mar 9,1972 under 2224-37; CDL:119792-A)
00092109
  Mobil Chemical Company (1971) Summary of Residue Analyses. Includes
  Method R-89-A dated Oct 7, 1969. (Compilation; unpublished study received
  Mar 9,1972 under 2224-37; CDL:119793-A)
00092116
00092135
  Mobil Chemical Company (1974) [Determination of Residues of Ethoprop in
  Various Crops]. Includes Method R-89-A. (Compilation; unpublished study,
  including published data, received Dec 17,1974 under 2224-48;
  CDL:220399-C)

  Mobil Chemical Company (1976) Summary of Residue Data: Mocap EC--
  Corn. (Compilation; unpublished study received Mar 29,1977 under 2224-
  44; CDL:229328-A)
00092147
  Fink, R.; Beavers, J.B.; Brown, R. (1978) Final Report: Acute Oral LD50 ~
  Mallard Duck: Ethoprop Technical: Project No. 155-104. (Unpublished study
  received Jan 4,1979 under 2224-54; prepared by Wildlife International, Ltd.,
  submitted by Mobil Chemical Co., Industrial Chemicals Div., Richmond, Va.;
  CDL:236710-C)
001-25395
  Interregional Research Project No. 4 (1978) The Results of Tests on the
  Amount of Residues Remaining in or on Okra, Including a Description of the
  Analytical Method Used: [Ethoprop]. (Compilation; unpublished study
  received Mar 14,1983 under 359-703; CDL:071458-A)
00125397
  Interregional Research Project No. 4 (1982) The Results of Tests on the
  Amount of [Ethoprop] Residues Remaining in or on Broccoli and Cabbage,
  Including a Description of the Analytical Method Used. (Compilation;
  unpublished study received Mar 14,1983 under 3E2852; CDL:071459-A)
                                         117

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    MRID#     CITATION
00128218
00129928
00138636
00141494
00142272
Duckworth, S.; Rusch, G.; Rinehart, W. (1980) An Acute Inhalation Toxicity
Study of MCTR 206-79 in the Rat: Project No. 79-7332. (Unpublished study
received May 4,1981 under 2224-44; prepared by Bio/dynamics, Inc.,
submitted by Interregional Research Project No. 4, New Brunswick, NJ;
CDL:070060-B)

Guyton, C. (1983) Ethoprop Residue Data on Peanuts Treated with a Narrow
Band Application of Mocap 10G: 1982 Field Program C-7: ASD No. 83/026.
(Unpublished study received Jul 26,1983 under 359-703; prepared by Morse
Laboratories, Inc., submitted by Rhone-Poulenc, Inc., Monmouth Junction,
NJ; CDL:250798-A)

Barnett, J.; Jenkins, L.; Parent, R.; et al. (1983) Evaluation of the Chronic
Toxicity and Oncogenic Potential of Ethoprop in Fischer 344 Rats: GSRI
Project No. 413-858-41. Final rept. (Unpublished study received Feb 8,1984
under 359-694; prepared by Gulf South Research Institute, submitted by
Rhone-Poulenc, Inc., Monmouth Junction, NJ;  CDL:252358-A; 252359)

Guyton, C. (1984) Ethoprop Residue Data for Peanut Hay, Hulls and Nutmeat
Following Two Applications of Mocap 10G: ASD No. 84/082. Unpublished
study prepared by Rhone-Poulenc Inc. 48 p.

Orth, D. (1984) Product Chemistry Testing for Ethoprop Technical and
Granular Formulation (MOCAP 10G): Final Report: Project Number 84-PL-
34; 84-PL-28. Unpublished study prepared by Biospherics Inc. 12 p.
00145970
Guyton, C. (1984) Ethoprop Residue Data on Green and Flue Cured Tobacco:
ASD No. 84/085. Unpublished compilation prepared by Rhone-Poulenc, Inc.
and Morse Laboratories, Inc. 43 p.
00152115
Beche, R. (1984) Ethoprop, Technical Grade Analysis and Certification of
Product Ingredients. Unpublished study prepared by Rhone-Poulenc
Agrochimie. 118 p.
00153065
00153326
Rhone-Poulenc Inc. (1985) Residue Data for Ethoprop. Unpublished
compilation. 131 p.

Guyton, C. (1985) Ethoprop Residue Data for California Cole Crops Treated
with Mocap EC at 12 LB AI/A  and Ethoprop Residue Data for Brussels
Sprouts Treated with Mocap 5G at 12 LB AI/A. Unpublished compilation
prepared by Rhone-Poulenc Inc. 102 p.
                                          118

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     MRH>#
CITATION
00154203
  Yanagihara, K. (1983) Residue Data in/on Pineapple Resulting from Mocap
  Drip Irrigation Treatments. Unpublished study prepared by University of
  Hawaii, Dept. of Agricultural Biochemistry. 127 p.
00160000
  Hudson, R,; Tucker, R.; Haegele, M. (1984) Handbook of toxicity of
  pesticides to wildlife: Second edition. US Fish and Wildlife Service:
  Resource Publication 153. 91 p.
00160171
  Jordan, E. (1986) Metabolism of Ethoprop (...) in Soil under Aerobic and
  Anaerobic Conditions: ASD No. 86/199. Unpublished study prepared by
  Rhone-Poulenc Inc. in cooperation with Mobil Environmental and Science
  Lab, 147 p.
00160179
  Brown, D. (1986) Ethoprophos: 52 Week Oral (Capsule Administration)
  Toxicity Study in the Beagle: Rept. No. 4923-198/16. Unpublished study
  prepared by Hazleton Laboratories Europe Ltd. 248 p.
00160180
  Barfknecht, T. (1985) Ames Salmonella/Microsome Plate Test (EPA/OECD):
  Ethoprop: Study No. PH 301-RP-001-85. Unpublished study prepared by
  Pharmakon Research International, Inc. 30 p.
00160181
  Stankowski, L. (1985) CHO/HGPRT Mammalian Cell Forward Gene
  Mutation Assay: Ethoprop: Study No. PH 314-RP-001-85. Unpublished study
  prepared by Pharmakon Research International, Inc. 52 p.
00160182
  Barfknecht, T. (1985) Rat Hepatocyte Primary Culture/DNA Repair Test:
  Ethoprop: Study No. PH 31 l-RP-001-85. Unpublished study prepared by
  Pharmakon Research International, Inc. 66 p.
00160183
  SanSebastian, J. (1985) In vitro Chromosome Aberration Analysis in Chinese
  Hamster Ovary (CHO) Cells: Ethoprop: Study No. PH 320-RP-001-85.
  Unpublished study prepared by Pharmakon Research International, Inc. 50 p.
00160184
  SanSebastian, J. (1986) In vitro Sister Chromatid Exchange in Chinese
  Hamster Ovary (CHO) Cells: Ethqprop: Study No. PH-319-RP-001-85.
  Unpublished study prepared by Pharmakon Research International, Inc. 92 p.
00160441
  Perez, G. (1986) Freezer Storage Stability of Ethoprop in Crops: ASD No.
  86/194. Unpublished study prepared by Morse Laboratories, Inc. 81 p.
                                         119

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    MRID#
CITATION
00160187
00160188
05008363
40028502
40228401
40291801
40356301
40378401
40386901
  Swigert, J.; Bowman, J. (1986) Acute Toxicity of Ethoprop to Blue-gill
  Sunfish (Lepomis macrochiras): Static Acute Toxicity Report #34319.
  Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc.
  53 p.

  Forbis, A.; Frazier, S.; Schoen, L. (1986) Acute Toxicity of Ethoprop
  Technical to Daphnia magna: Static Acute Toxicity Report #34320.
  Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc.
  38 p.

  Hudson, R.H.; Haegele, M.A.; Tucker, R.K. (1979) Acute oral and
  percutaneous toxicity of pesticides to mallards: correlations with mammalian
  toxicity data.  Toxicology and Applied Pharmacology 47(3):451-460.

  Fronek, F. (1986) Crop Residue Information: UAP 101: Study No. 86-8A.
  Unpublished compilation prepared by The Industrial Laboratories Co. 59 p.

  Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Interpretation and
  Data Base for 410 Chemicals and 66 Species of Freshwater Animals. US Fish
  & Wildlife Service, Resource Publication 160.579 p. (Study is duplicate of
  MRID# 40098001)

  Spicer, E. (1987) Lifetime Dietary Toxicity and Oncogenicity Study in Rats:
  IRDC Study No. 347-029. Unpublished study prepared by International
  Research & Development Corp. 2574 p.

  Inoue, H. (1984) Chronic Feeding and Oncogenicity Studies in Mice with
  Ethoprop: Rept No. 497. Unpublished study prepared by Biosafety Research
  Center (AN-PYO Center). 2490 p.

  Schafer, E.W.; Brunton, R.B. 1979. Indicator bird species, for toxicity
  determinations: Is the technique usable in test method development?
  Vertebrate Pest Control and Management Materials, ASTM STP 680, J.R.
  Beck, Ed., American Society for Testing and Materials, 1979, pp. 157-168.
  (cited in the EFED Environmental Risk Assessment as reference GS0106004)

  Dearlove, G. (1987) Dominant Lethal Study of Ethoprop Technical
  Administered Orally Via Gavage to CrhCOBS CD (SD)BR Male Rats: Final
  Rept.: Protocol No. 218-004. Unpublished study prepared by Argus Research
  Laboratories, Inc. 569 p.
                                          120

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  O-ethyl-S-propylphosphorothioate (Ml) in Rats with Determination of Effects
  on Cholinesterase Activity: Final Report: Lab Project Number: COVANCE
  6224-250: PROPOSAL 23237A. Unpublished study prepared by Covance
  Laboratories Inc. 77 p.

  Lewis, C. (1993) (14-carbon)-Ethoprophos: Degradation and Retention in
  Water/Sediment Systems: Final Report: Lab Project Number: 68/135-1015:
  P6875D. Unpublished study prepared by Hazleton UK. 172 p.

  Temple, D.; Lee, T.; Palmer, D. (1999) MOCAP EC: An Evaluation of its
  Effects Upon Avian Species on and around Potato Fields in the Columbia
  Basin of Washington State: Lab Project Number. 171-132: ML92-0302-RHP:
  171/022692/MPWA/CYP6. Unpublished study prepared by Wildlife
  International, Ltd. and Morse Laboratories, Inc. 423 p.

  Temple, D.; Lee, T.; Palmer, D. (1999) MOCAP 10G: An Evaluation of its
  Effects Upon Avian Species on and around Potato Fields in the Columbia
  Basin of Washington State: Lab Project Number: 171-128: ML91-0236-RHP:
  171/092590/10G/CYP6. Unpublished study prepared by Wildlife
  International, Ltd. and Morse Laboratories, Inc.  422 p.

  Austin, E. (2000) 4-Week Repeated Dose Dermal Toxicity Study with Mocap
  20G in Rats: Lab Project Number 6224-263. Unpublished study prepared by
  Covance Labs. 141 p.

  Temple, D.; Lee, T.; Palmer, D. (2000) Mocap EC: An Evaluation of its
  Effects Upon Avian Species and Other Wildlife on and Around Tobacco
  Fields in North Carolina: Lab Project Number: 171-127. Unpublished study
  prepared by Wildlife International, Ltd. 499 p.

  Kenwood, S. (1990) 3-Week Dermal Toxicity Range-Finding Study with
  Ethoprop Technical in Rats: Final Report: Lab Project Number: HLA
  6224-160: TP9279. Unpublished study prepared by Hazleton Laboratories
  America, Inc. 181 p.

  .Kenwood, S. (1990) 3-Week Dermal Toxicity Study with Ethoprop Technical
  in Rats: Final Report: Lab Project Number: HLA 6224-162: ETP-TP-90-1014:
  TP9328. Unpublished study prepared by Hazleton Laboratories America, Inc.
  274p.
                                          132

-------
    MRTD#
CITATION
45079706
45113102
  Lincbick, C.; Powell, G. (2000) Temik Brand ISO-Quality Control Data on
  Dust Control of Gypsum and Grit Formulations: Lab Project Number
  02ALDOO/AVENHS. Unpublished study prepared by Aventis CropScience.
  101 p. Temik dust data

  Wilson, A. (1999) ETHOPROPHOS Biomonitoring Exposure to Applicators
  and Loaders During Typical Application Activities with MOCAP 10G
  Applied to Potatoes in the United Kingdom: Lab Project Number: RNP 617:
  RNP 617/993560. Unpublished study prepared by Huntingdon Life Sciences
  Ltd. 71 p.
45167201
  Urtizberea, M. (1999) Worker Exposure Study During Application in Banana
  Plantation with Temik 10G: Lab Project Number: SA 98337:
  RPS/ALD/98072. Unpublished study prepared by ADME Bioanalyses. 156 p.
45184402
  Temple, D.; Lee, T.; Palmer, D. (2000) MOCAP 10G: An Evaluation of Its
  Effects Upon Avian Species on and Around Potato Fields in Maine: Lab
  Project Number: 171-131. Unpublished study prepared by Wildlife
  International, Ltd. 445 p.
45206301
  Ligon, R. (2000) Perceived Dust Evaluation of MOCAP Granulars: Lab
  Project Number: WOODBINE 08180. Unpublished study prepared by
  Aventis CropScience. lip.
45206302
  Lunchick, C. (2000) Aventis CropScience Comments and Revisions
  Pertaining to the U.S. EPA Re-Assessment of the Occupational Exposure and
  Risk of Ethoprop for the Reregistration Eligibility Document Dated 18 May
  2000. Unpublished study prepared by Aventis CropScience. 14 p.
45250702
  Pontal, P. (1996) Fipronil: Worker Exposure Study During Application of
  Regent 20GR in Banana Plantation: Lab Project Number: 338/95/0072:
  94/136: 94002 HI. Unpublished study prepared by Rhone-Poulenc
  Agrochemie. 196 p.
45285901
  Carringer, R. (2000) The Benefits of Mocap EC F6rmulation of Ethoprop for
  the Minor Crops of Tobacco, Sweet Potato, Cabbage, and Cucumber.
  Unpublished study prepared by The Carringers, Inc. 23 p.
45388504
  Lignon, R. (2001) Perceived Dust Evaluation of MOCAP Granulars: Lab
  Project Number: WOODBINE 03231. Unpublished study prepared by Aventis
  CropScience. 22 p.
                                         133

-------
45388505
45535501
Hou, A. (2001) Particle Size of Biodac Through Light Scatteiing-Camsizer.
Unpublished study prepared by Horiba Instruments Incorporated. 17 p.

Anderson, C.; Wood, T.; Morace, J. (1997) Distribution of Dissolved
Pesticides and Other Water Quality Constituents in Small Streams, and then-
Relation to Land Use, in the Willamette River Basin, Oregon, 1996. U.S.
Geological Survey Water-Resources Investigations Report. 87 p.
                                          134

-------
Appendix E.
Generic Data Call-In
       See the attached table for a listing of the generic data requirements. Note that a complete
Generic Data Call-In (DCI), with all pertinent instructions, is being sent to each registrant under
separate cover.
                                            135

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Appendix F.
Product Specific Data Call-in
       See the attached table for a listing of the product-specific data requirements. Note that a
complete Product Specific Data Call-In (DCI), with all the pertinent instructions, is being sent to
each registrant under separate cover.
                                            143

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Appendix G.        Batching of Ethoprop 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 reregistratioh of products containing ethoprop as an 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 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. Notwithstanding the batching process, the Agency reserves the right
to require, at any time, acute toxicity data for an individual product should 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 the 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 the 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 todays 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 are generated or existing data are referenced, the 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 (DCI) Notice and its attachments appended to the IRED.  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 the 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 registrant'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.
                                            149

-------
       With the voluntary cancellation of various products by the various registrants, there are five
remaining products which contain ethoprop as the active ingredient.  These products have been
placed into 4 batches in accordance with the active and inert ingredients and type of formulation.
Please note that this batching scheme may not apply to products with CSFs that have been revised
after generation of this document.
Batch 1


EPA Reg. No.
264-456
264-599
Percent Active Ingredient
95.9
94.4
Formulation Type
Technical; Solid
Technical; Solid
Batch 2

EPA Reg. No.
264-4-58
Percent Active Ingredient
69.6
Formulation Type
Emulsifiable Concentrate;
Liquid
Batch 3

EPA Reg. No.
264-4.69
Percent Active Ingredient
20.0
Formulation Type
Solid; clay-based
Batch 4

EPA Reg. No.
264-457
Percent Active Ingredient
15.0 	
Formulation Type
Solid; cellulose-based
                                           150

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Appendix H.       List of Registrants Sent this Data Call-In
                                          151

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Appendix I.
List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
                   http://www.epa.gov/opprdQ01/fonns/.

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 hard-copy in accord with the
                   existing policy.

       3.           Mail the forms, along with any additional documents necessary to comply
                   with EPA regulations covering your request, to the address below for the
                   Document Processing Desk.

                   DO NOT fax or e-mail any form containing "Confidential Business
                   Information" or "Sensitive Information."

                   If you have any problems accessing these forms, please contact Nicole
                   Williams at (703) 308-5551 or by e-mail at: wilh'ams.nicole@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
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 Registrants
for Development of Data
Certification with Respect to Citations of Data (in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
http://Ww.epa.Eov/orord001/forms/8570-l.pdf.
http://www.epa.Eov/oOTid001/forms/8570-4.rjdf.
http://www.epa.gov/otiprd001/fonns/8570-5.pdf.
http://www.erB.eov/OOTrd001/forms/8570-17.txif.
http://www.epa.Bov/otrord001/forms/8570-25.pdf.

http://www.epa.Eov/cnrori001/forms/8570-27.Ddf.
http://www.epa.Eov/OOTrd001/forms/8570-28.Ddf.
http://www.epa.sov/orrord001/forms/8570-30.Ddf.
http^/www.epa.eov/onord001/fonns/8570-32.pdf.

http://www.epa.Eov/opromsdl/PRJNotices/or98-5.p
df
http://www.epa.gov/oprromsdl/PR_Notices/nr98-5.p
df.
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8570-36
8570-37
Summaiy of the Physical/Chemical Properties (in PR Notice 98-1)
Self-Certification Statement for the Physical/Chemical Properties (in PR
Notice 98-1)
httn-yAvww.eoa.BOV/OBOomsdl/PR Notices/m98-l.t>
&
httD://www.ena.eov/oT>DT>msdl/PR Notices/nr98-l.o
<
Pesticide Registration Kit
      www.epa.gov/pesticides/registiatioiikit/.

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 ProgramStorage 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
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      4.
General Pesticide Information (Some of these forms are in PDF format and
will require the Acrobat reader.)
                   a. Registration Division Personnel Contact List
                   b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
                   c. Antimicrobials Division Organizational Structure/Contact List
                   d. 53 FR15952, Pesticide Registration Procedures; Pesticide Data
                   Requirements (PDF format)
                   e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
                   format)
                   f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
                   g. 50 FR 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.

       2.
The Office of Pesticide Programs' Web Site

The booklet "General Information on Applying for Registration of Pesticides
in the United States", PB92-221811, available through the National Technical
Information Service (NTIS) at the following address:

National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161

The telephone number for NTIS is (703) 605-6000.  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.

The National Pesticides 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.
http://ceris.purdue.edu/npirs/npirs.htrnl

The National Pesticides Information Center (NPIC), formerly the National
Pesticide Telecommunications Network (NPTN), can provide information on
active ingredients, uses, toxicology, and chemistry of pesticides.  You can
contact NPTN by telephone at (800) 858-7378 or through their Web site:
www.nDic.orst.edu/index.html
                   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,

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self-addressed postcard. The postcard must contain the following entries to be
completed by OPP:

- Date of receipt
- EPA identifying number
.- Product Manager assignment

Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted.  EPA will
stamp the date of receipt and provide the EPA identifying File Symbol or
petition number for the new submission.  The identifying number should be
used whenever you contact the Agency concerning an application for
registration, experimental use permit, or tolerance petition.

To assist us in ensuring that all data you have submitted for the chemical are
properly coded and assigned to your company, please include a list of all
synonyms, common and trade names, company experimental codes, and other
names which identify the chemical (including "blind" codes used when a
sample was submitted for testing by commercial or academic facilities).
Please provide a  CAS number if one has been assigned.
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