United States       Prevention, Pesticides     EPA-738-R-98-003
         Environmental Protection    And Toxic Substances     October 1998
         Agency	(7508C)	
&EPA  Reregistration
         Eligibility Decision (RED)

         Dichlobenil

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                   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                       WASHINGTON, D.C. 20460
                                                                            OFFICE OF
                                                                      PREVENTION, PESTICIDES
                                                                       AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:

       I am pleased to announce that the Environmental Protection Agency has completed its
reregi strati on eligibility review and decisions on the pesticide chemical case number 0263,
dichlobenil. The enclosed Reregi strati on Eligibility Decision (RED), which was approved on
September 20,  1997, contains the Agency's evaluation of the data base of this chemical, its
conclusions of the potential human health and environmental risks of the current product uses,
and its decisions and conditions under which these uses and products will be eligible for
reregistration.  The RED includes the data and labeling requirements for products for
reregistration.  It also includes requirements for additional data (generic) on the active ingredients
to confirm the risk assessments.

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

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

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

       If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the Special Review and Reregi strati on Division representative Bonnie
Adler at (703) 308-8523. Address any questions on required generic data to the Special Review
and Reregi strati on Division representative Dana Lateulere at (703) 308-8044.
                                                       Sincerely yours,
                                                       Lois A. Rossi, Director
                                                       Special Review and
                                                        Reregi strati on Division
Enclosures

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

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

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

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

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

       b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations  (40 CFR 156.10) and policies.  Submit any other amendments (such as formulation
changes, or labeling changes not related to reregi strati on) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregi strati on. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on Applying
for Registration in the U.S., Second Edition, August 1992" (available from the National Technical
Information Service, publication #PB92-221811; telephone number 703-605-6000).

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

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

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comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
§158.175) or (2) provide certified limits that are supported by the analysis of five batches.  If you
choose the second option, you must submit or cite the data for the five batches along with a
certification statement as described in 40 CFR §158.175(e).  A copy of the CSF is enclosed;
follow the instructions on its back.

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

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

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

By U.S. Mail:

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

By express:

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

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

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REREGISTRATION ELIGIBILITY DECISION

               DICHLOBENIL

                   LIST A

                 CASE 0263
           ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF PESTICIDE PROGRAMS
         SPECIAL REVIEW AND REREGISTRATION DIVISION

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                           TABLE OF CONTENTS



DICHLOBENIL REREGISTRATION ELIGIBILITY DECISION TEAM               i

EXECUTIVE SUMMARY                                                        v

I.     INTRODUCTION                                                         1

II.    CASE OVERVIEW                                                        3
      A.    Chemical Overview  	3
      B.    Use Profile                                                         3
      C.    Estimated Usage of Pesticide	5
      D.    Data Requirements	7
      E.    Regulatory History	8

III.   SCIENCE ASSESSMENT                                                  9
      A.    Physical Chemistry Assessment	9
      B.    Human Health Assessment 	11
            1.     Toxicology Assessment	11
                   a.    Acute Toxicity                                         11
                   b.    Subchronic Toxicity  	12
                   c.    Chronic toxicity	12
                   d.    Combined Chronic/Carcinogenicity	13
                   e.    Developmental Toxicity	15
                   f.     Reproductive Toxicity                                  15
                   g.    Mutagenicity                                          16
                   h.    Metabolism                                           16
                   i.     Dichlobenil Toxicological Endpoints of Concern Identified for
                        Use in Human Risk Assessment 	18
                   j.     Acute Toxicity of BAM                                 19
                   k.    Subchronic Toxicity of BAM                            19
                   1.     Combined Chronic Toxicity/Carcinogenicity Study of BAM . 19
                   m.    Developmental Toxicity of BAM 	20
                   n.    3-Generation Reproduction Study of BAM	21
                   o.    Mutagenicity of BAM                                  21
                   p.    BAM Toxicological Endpoints of Concern Identified for Use in
                        Human Dietary Risk Assessment	22
            2.     Exposure Assessment 	22
                   a.    Dietary Exposure                                      22
                   b.    Dietary Exposure (Water)                               27
                   c.    Occupational and Residential                            28

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             3.     Risk Assessment 	33
                   a.     Acute Dietary                                          33
                         (1)    Dichlobenil                                      33
                         (2)    BAM	34
                   b.     Chronic Dietary                                        34
                         (1)    Dichlobenil                                      34
                         (2)    BAM  	35
                   c.     Short-Term Nondietary                                 36
             4.     FQPA Considerations                                         39
                   a.     Assessment of Additional Sensitivity to Infants and Children 40
                   b.     Aggregate (Multi-Pathway) Exposure and Resultant Risk   42
      C.     Environmental Assessment                                           44
             1.     Ecological Toxicity Data                                       44
                   a.     Toxicity to Terrestrial Animals                           44
                   b.     Toxicity to Aquatic Animals                             47
                   c.     Toxicity to Plants                                       52
             2.     Environmental Fate                                           53
                   a.     Environmental Fate and Transport                       53
                   b.     Water Resources                                       58
                   c.     Environmental Fate Assessment                          65
             3.     Ecological Exposure and Risk Characterization                   67
             4.     Environmental Risk Characterization                           79
                   a.     Overview of the Chemical                               79
                   b.     Overview of the Findings                                79

IV.   RISK MANAGEMENT AND REREGISTRATION DECISION                83
      A.     Determination of Eligibility	83
      B.     Determination of Eligibility Decision 	84
             1.     Eligibility Decision                                            84
             2.     Eligible and Ineligible Uses                                     84
      C.     Regulatory Position                                                  84
             1.     Food Quality Protection Act Findings                           84
             2.     Endocrine Disrupter Effects                                   86
             3.     Tolerance Reassessment	86
             4.     Tolerance Revocations and Import Tolerances	88
                   a.     Human Health                                         89
                   b.     Environmental	91
             5.     Restricted Use Classification  	95
             6.     Endangered Species Statement  	95
             7.     Occupational/Residential Labeling Rationale	95
                   a.     Personal  Protective  Equipment/Engineering  Controls  for
                         Handlers for Occupational-Use Products (WPS and NonWPS
                         Uses)	96
                   b.     PPE/ Engineering Controls for Homeowner-Use Products . . 97
                   c.     Post-Application/Entry Restrictions	98

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            8.     Ground-Water Advisory                                      100
            9.     Application Rate Reduction                                   100
            10.    10G Soil Incorporation Requirements	100

V.    ACTIONS REQUIRED OF REGISTRANTS                                100
      A.    Manufacturing-Use Products	100
            1.     Additional Generic Data Requirements	100
                   a.     Requirements for Handler (Mixer/Loader/Applicator) Exposure
                         Studies	101
                   b.     Requirements for Post-Application Studies                101
                   c.     Requirements for BAM Chemistry and Environmental Fate
                         Studies	101
                   d.     Requirements for Drinking-Water Monitoring Studies  ...101
                   e.     Requirements for Prospective Groundwater Monitoring
                         Studies	102
                   f.     Requirements for Forestry Dissipation  	102
                   g.     Requirements for Avian Reproduction Studies             102
            2.     Labeling Requirements for Manufacturing-Use Products	102
      B.    End-Use Products                                                  103
            1.     Additional Product-Specific Data Requirements                  103
            2.     Labeling Requirements for End-Use Products  	103
                   a.     Ground-Water Advisory                               103
                   b.     Application Rate Reduction                             103
                   c.     10G Soil Incorporation Requirements	103
                   d.     Occupational Labeling                                 104
                         (1)    PPE Requirements for Pesticide Handlers           104
                         (2)    Post-Application/Entry Restrictions for Products Intended
                               Primarily for Occupational Use  	106
                         (3)    Post-Application/Entry Restrictions for Products Intended
                               Primarily for Home Use	107
                         (4)    Other  Labeling  Requirements  for  Products Intended
                               Primarily for Occupational Use  	107
      C.      Tolerance Revocation and Import Tolerances  	108
      D.    Existing Stocks	109

VI.   APPENDICES                                                           111
      APPENDIX  A.     Table of Use Patterns Subject to Reregistration            113
      APPENDIX  B.     Table  of the Generic Data Requirements and Studies  Used to
                         Make the Reregistration Decision  	139
      APPENDIX  C.     Citations Considered to be Part of the Data Base Supporting the
                         Reregistration of Dichlobenil  	152
      APPENDIX  D.     Combined  Generic and Product Specific Data Call-In       175
            Attachment  1.     Chemical Status Sheets                          195
            Attachment  2.     Combined Generic and Product Specific Data Call-In
                               Response Forms (Form A inserts) Plus Instructions   197

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      Attachment  3.
      Attachment  4.
      Attachment  5.
      Attachment  6.
APPENDIX  E.
Generic and Product Specific Requirement Status and
Registrant's Response  Forms  (Form  B inserts) and
Instructions 	201
EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration	208
List of All Registrants  Sent This Data Call-in (insert)
Notice	213
Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions  	215
List of Available Related Documents  	225

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DICHLOBENIL REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:

Biological and Economic Analysis Division

James Saulmon
Gabe Patrick
Eric Maurer

Environmental Fate and Effects Division

Estella Waldman
Kevin Poff
Betsy Grim
Mike Davy
David Wells

Health Effects Division

Kathryn Boyle
Paul Chin
Christine Olinger
Jeff Evans
Brian Steinwand

Registration Division

Jim Stone

Special Review  and Reregi strati on Division

Linda Propst
Susanne Cerrelli
Biological Analysis Branch
Label Use Information System
Economic Analysis Branch
Environmental Fate and Groundwater Branch
Environmental Fate and Groundwater Branch
Ecological Risk Characterization Branch
Ecological Risk Characterization Branch
Ecological Risk Characterization Branch
Risk Characterization and Analysis Branch
Toxicology Branch I
Chemistry Branch Reregi strati on Support
Occupational and Residential Exposure Branch
Science Analysis Branch
Fungicide-Herbicide Branch
Reregi strati on Branch
Reregi strati on Branch

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             GLOSSARY OF TERMS AND ABBREVIATIONS

ADI            Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE             Acid Equivalent
a.i.              Active Ingredient
ARC            Anticipated Residue Contribution
CAS            Chemical Abstracts Service
CI              Cation
CNS            Central Nervous System
CSF            Confidential Statement of Formula
DFR            Dislodgeable Foliar Residue
ORES           Dietary Risk Evaluation System
DWEL          Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
                water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to occur.
EEC            Estimated Environmental Concentration. The estimated pesticide concentration in an environment, such
                as a terrestrial ecosystem.
EP              End-Use Product
EPA            U.S. Environmental Protection Agency
FAO/WHO      Food and Agriculture Organization/World Health Organization
FDA            Food and Drug Administration
FIFRA          Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA         Federal Food, Drug, and Cosmetic Act
FQPA           Food Quality Protection Act
FOB            Functional Observation Battery
GLC            Gas Liquid Chromatography
GM            Geometric Mean
GRAS           Generally Recognized as Safe as Designated by FDA
HA             Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
                organizations when emergency spills or contamination situations occur.
HOT            Highest Dose Tested
LC50            Median Lethal Concentration. A statistically derived concentration of a substance that can be expected
                to cause death in 50% of test animals.  It is usually expressed as the weight of substance per weight or
                volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50            Median Lethal Dose. A statistically derived single dose that can be  expected to cause death in 50% of
                the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as
                a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo            Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL            Lowest Effect Level
LOG            Level of Concern
LOD            Limit of Detection
LOEL           Lowest Observed Effect Level
MATC          Maximum Acceptable Toxicant Concentration
MCLG          Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate contaminants
                in drinking water under the Safe Drinking Water Act.
Hg/g            Micrograms Per Gram
//g/L            Micrograms per liter
mg/L            Milligrams Per Liter
MOE           Margin of Exposure
MP             Manufacturing-Use Product
MPI            Maximum Permissible Intake
MRID           Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A            Not Applicable
                                                   111

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             GLOSSARY OF TERMS AND ABBREVIATIONS

NOEC          No Observable Effect Concentration
NPDES         National Pollutant Discharge Elimination System
NOEL          No Observed Effect Level
NOAEL         No Observed Adverse Effect Level
OP             Organophosphate
OPP            Office of Pesticide Programs
Pa              pascal,  the pressure exerted by a force of one newton acting on an area of one square meter.
PADI           Provisional Acceptable Daily Intake
PAG            Pesticide Assessment Guideline
PAM           Pesticide Analytical Method
PHED          Pesticide Handler's Exposure Data
PHI             Preharvest Interval
ppb             Parts Per Billion
PPE            Personal Protective Equipment
ppm            Parts Per Million
PRN            Pesticide Registration Notice
Q*!             The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC            Red Blood Cell
RED            Reregistration Eligibility Decision
REI             Restricted Entry Interval
RfD            Reference Dose
RS             Registration Standard
RUP            Restricted Use Pesticide
SLN            Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC             Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD             Toxic Dose.  The dose at which a substance produces a toxic effect.
TEP            Typical End-Use Product
TGAI           Technical Grade Active Ingredient
TLC            Thin Layer Chromatography
TMRC          Theoretical Maximum Residue Contribution
torr             A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
WP             Wettable Powder
WPS            Worker Protection Standard
                                                  IV

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EXECUTIVE SUMMARY

       The U. S.  Environmental Protection Agency has completed its reregistration eligibility
decision of the pesticide dichlobenil. This decision includes a comprehensive reassessment of the
required data and the use patterns of currently registered products. On August 3, 1996, the President
signed the "Food  Quality Protection Act of 1996"  which amended the Federal Food Drug and
Cosmetic Act and the Federal Insecticide, Fungicide and Rodenticide Act.  These two Federal statutes
provide the framework for pesticide regulation in  the United States.  FQPA became effective
immediately upon signature and all reregistration eligibility decisions  (REDs) signed subsequent to
August 3rd are accordingly being evaluated under the new standards imposed by FQPA.

       The primary focus of FQPA is to require a more comprehensive evaluation of pesticide risks
to infants and children from their diet, but also from non-food exposures such as drinking water and
residential type exposures  when issuing or reassessing tolerances.  Specifically, based on available
information, the Agency will be evaluating 1) aggregate risks of a particular pesticide from various
exposure routes and 2) the cumulative effects of a pesticide and other  substances that have a common
mode of toxicity. Consideration of aggregate risks and cumulative effects with respect to the general
population will also be considered in issuing or reassessing tolerances. The Act further directs EPA
to consider the potential for increased susceptibility of infants and children to the toxic effect of
pesticide residue.

       Dichlobenil (2,6-dichlorobenzonitrile) is  a herbicide used on cranberry bogs,  dichondra,
ornamentals, blackberry, raspberry, and blueberry fields, apple, pear, filbert and cherry orchards,
vineyards, hybrid poplar-cottonwood plantations, and rights-of-way to control weeds; and sewers to
remove roots.  The Agency can not make a decision as to the eligibility of the sewer treatment and
the granular backpack application of dichlobenil at this time because additional data are needed to
evaluate exposure of mixer/loader/applicators for these  uses.  Under FIFRA,  The Agency has
concluded that the remaining uses,  labeled and used as specified in this document, will not cause
unreasonable  risks to  humans  or  the  environment.  Therefore, all  products  are eligible  for
reregistration except for  those  registered  for application  to  sewer sites  or granular backpack
application.

       The Agency  has reassessed food tolerances  for the combined residues of the herbicide
dichlobenil (2,6-dichlorobenzonitrile) and its metabolite 2,6-dichlorobenzamide (BAM) under the
standards of FQPA and determined that the existing  tolerances with amendments  and  changes as
specified in this document meet the safety standards of FQPA.  Based on available information, there
is reasonable certainty that no harm will result to infants and children or to the general  population
from aggregate  exposure  to dichlobenil or BAM residues.  An additional  uncertainty factor for
sensitivity to infants and children was not needed to assess the risk  of dichlobenil.   Drinking water
monitoring data for both dichlobenil and its BAM metabolite are required to confirm this assessment.
 Insufficient information is  available for the Agency to make  a determination of whether or not
dichlobenil shares a common mode of toxicity with other chemicals.

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       To mitigate risks of potential developmental toxicity to workers the Agency is requiring,
among other changes, the use of personal protective equipment; reentry intervals of 24 hours for
horticultural/ nursery uses; reentry intervals of 12 hours for all other uses; open windows or exhaust
fan during sewer treatment application to inhabited buildings;  soil incorporation or watering-in of
dichlobenil for horticultural uses,  such as  use on dichondra, soil or gravel in liners that house
ornamental stock, and for all soil uses around  established ornamental trees and shrubs, and other non
crop areas such as buildings, fences, and other structures is required. It is also recommended that
products primarily intended for homeowner use be watered-in. Re-entry would be restricted until the
soil is dry following the watering-in of the product.

       Dichlobenil and its metabolite BAM have the potential to leach into ground water, but only
limited detection  data are available.  To address these concerns the Agency is requiring a ground
water advisory on labels, and a drinking  water monitoring study.  In addition a ground water
monitoring study is required for the hybrid cottonwood sites outside of Oregon and Washington
desert areas.  To reduce environmental risks to birds, mollusks, fish, invertebrates, and non-target
plants, a reduction of the 20 Ib. ai/A maximum application rate to 10 Ibs ai/A is being imposed.  In
addition, to mitigate acute risks to  endangered birds, the Agency is requiring that the label for the
10G formulation impose soil incorporation. Additional data for re-entry exposure, residue chemistry,
forestry dissipation, drinking water, and ground water monitoring are being required to be submitted
to confirm the Agency's risk assessment and conclusions. Avian reproduction data are being required
to enable the Agency to assess chronic risks to birds.  To assess the reregistration eligibility of sewer
sites and granular backpack application sites, data are required for estimation of inhalation and dermal
exposure to mixer/loader/applicators.
                                            VI

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I.      INTRODUCTION

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

       FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for reregistration" before calling in data on
products and either reregistering products or taking  "other appropriate regulatory action." Thus,
reregistration  involves  a thorough review  of the scientific  data base  underlying  a pesticide's
registration. The purpose of the Agency's review is to reassess the potential hazards arising from the
currently registered uses of the pesticide; to determine the need for additional data on health and
environmental effects; and to determine whether the pesticide meets the "no unreasonable adverse
effects" criterion of FIFRA.

       On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 301 et seq..,  and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C.
136 et seq.  The FQPA amendments went into effect immediately. Among other things, FQPA
amended the FFDCA by establishing a new safety standard for the establishment of tolerances.  The
FQPA does not, however, amend any of the existing reregistration deadlines set forth in §4 of FIFRA.
Thus, EPA is embarking on an intensive process, including consultation with registrants, States, and
other interested stakeholders, to make decisions on the  new policies and procedures that will be
appropriate as a result of enactment of FQPA. This process will  include a more in-depth analysis of
the new safety  standard and how it should be applied to both food  and non-food pesticide
applications. However, in light of the unaffected statutory deadlines with respect to reregistration,
the Agency will continue its ongoing reregistration program while it continues to determine how best
to implement FQPA.

       This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of dichlobenil including the risk to infants and children for any potential  dietary (food
source and drinking water), residential (dermal, inhalation or non-dietary ingestion), and cumulative
effects as stipulated under the FQPA.

The document consists of six sections. Section I is the introduction. Section II describes dichlobenil,
its  uses, data requirements and regulatory history. Section III discusses the human health and
environmental assessment based on the  data available  to the Agency.  Section IV presents the
reregistration decision for dichlobenil.  Section V discusses the reregistration requirements for

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dichlobenil. Finally,  Section VI is the  Appendices  which support this Reregi strati on Eligibility
Decision. Additional details concerning the Agency's  review of applicable data are  available on
request.

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II.     CASE OVERVIEW

       A.    Chemical Overview

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

       !      Common Name:     Dichlobenil

       !      Chemical Name:  2,6-dichlorobenzonitrile

       !      Chemical Family:    Benzonitrile

       !      CAS Registry Number:    1194-65-6

       !      OPP Chemical Code: 027401

       !      Empirical Formula:  C7H3C12N

       !      Trade and Other Names:   Casoron, Norosac, Barrier, Dyclomec, H 133, Prefix
                                       D, Decabane, and DCBN

       !      Basic Manufacturer:       Uniroyal


       B.    Use Profile

The following is information on the currently registered uses for dichlobenil with an overview of use
sites and application methods. A detailed table of dichlobenil uses is in Appendix A.

Type of Pesticide:  Herbicide

Mechanism of action:
Inhibits germination of actively dividing meristems.  Acts primarily on growing points and root tips.

Use Sites:

TERRESTRIAL FOOD CROP
Nut Crops [filbert (hazelnut)]; Pome Fruits [pear];  Small Fruits [blackberry, blueberry, cranberry,
raspberry (black, red)]; Stone Fruits [cherry]

TERRESTRIAL FOOD+FEED CROP

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General Soil Treatments and Composting [compost/compost piles, soil, preplant/outdoor]; Pome
Fruits [apple]; Small Fruits [grapes]

TERRESTRIAL NON-FOOD CROP
Agricultural  Uncultivated Areas [agricultural rights-of-way/fencerows/hedgerows, agricultural
uncultivated areas]; Nonagricultural Uncultivated Areas [industrial areas (outdoor), nonagricultural
outdoor buildings/structures, nonagri cultural rights-of-way/fencerows/hedgerows, nonagri cultural
uncultivated areas/soils, paved areas (private roads/sidewalks), recreational area]; Ornamental Lawns
and Turf

TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
Industrial Preservatives [adhesives, industrial]; Ornamental Lawns and Turf; Ornamental Woody
Shrubs and Vines; Ornamental and/or Shade Trees

AQUATIC NON-FOOD INDUSTRIAL
Aquatic Sites [drainage systems, sewage systems]

FORESTRY
Forest Trees [forest plantings (reforestation programs, tree farms, tree plantations, etc.), all or
unspecified forest trees, hybrid cottonwood/poplar plantations,  shelterbelt plantings]

Target Pests for Single Active Ingredient:
Weeds:  dandelion, prickly oxtongue (preemergence), tree roots

Formulation Types Registered:

Type:  Technical Grade Active Ingredient
Form:  Not identified/solid         98.0000 to 99.5000%

Type:  Manufacturing Product
Form:  Not identified/solid         85.0000%
      Wettable powder            85.0000%

Type:  End use product
Form:  Granular                  1.0000 to 10.0000%
       Liquid-ready to use         0.5000%
       Soluble concentrate/solid    0.5000%
       Wettable powder           0.5500 to 85.0000%

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Method and Rates of Application:

Types of Treatment
Broadcast; Foam application; Perimeter treatment; Prepaying treatment;  Sewer treatment;  Soil
incorporated treatment; Soil treatment

Equipment
Aircraft; By hand; Foam applicator; Foam-making generator; Glove; Granule applicator; Ground; Not
on label; Package applicator; Rod; Soil incorporation equipment; Toilet bowl; Tractor-mounted
granule applicator

Timing
Bearing; December; Early spring; Early winter; February; January; Late fall; Nonbearing; November;
Nurserystock; Postemergence; Postharvest; Prebloom; Spring; Stool bed; When needed; Winter
       C.     Estimated Usage of Pesticide

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

According to the Agency's records, dichlobenil is registered on more than 20 agricultural and six non-
agricultural use sites.  Based  on proprietary  and non-proprietary usage data from 1993  - 1995,
approximately 150,000 - 225,000 pounds active ingredient are used to treat about 55,000 - 95,000
acre treatments in the aggregate. The agricultural sites represent nearly 58 percent of this total of
which ornamental plants, trees, and turf represent 66 percent of the agricultural total and 38  percent
of the aggregate total.  Other important sites include the homeowner use which represents 51 -62
percent of the non-agricultural total and 22 - 26 percent of the aggregate total as well  as cranberries
represent 16 percent of the agricultural total and approximately ten percent of the aggregate total.
There is not one major region or state which accounts for the majority of the usage.

The following table summarizes the pesticides use by site.

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Percent of Various U.S. Crops Treated Annually with Dichlobenil, 1993 - 1995
Site/1
Acres
Grown/2
(000)
Acres
Treated/3
(000)
Percent
Crop
Treated
Pounds AI
Applied
(000)
Major Region or
State
Agricultural Sites
Apple
Blackberry
Blueberry
Cherry
Cranberry
Filbert
Golf Courses
Grape
Nectarine*
Orange*
Ornamental Plants
Ornamental Trees
Ornamental Turf
Peach*
Pear
Plums/Prune*
Raspberry
Ae Totals
457.1
4.8
35.1
93.4
29.6
27.0
1,202
757.4
27.4
675.6
701.6
	
	
176.4
70.2
127.9
12.2
N/A
5- 10
<1 - 1
<1 - 1
<1 - 1
10- 15
1 -2
<1 - 1
1 -2
<1 - 1
<1 - 1
5- 10
5- 10
5- 10
<1 - 1
<1 - 1
<1 - 1
<1 - 1
42-69
1 -2
<1 -21
<1 -3
<1 - 1
34-51
3 -8
<1 - 1
<1 - 1
<1 - 1
<1 - 1
<1 -2
	
	
<1 - 1
<1 - 1
<1 - 1
<1 - 1
N/A
1 -5
<1 - 1
<1 - 1
<1 - 1
15-20
2-4
<1 - 1
1 -5
<1 - 1
<1 - 1
30-40
15-25
15-20
<1 - 1
<1 - 1
<1 - 1
<1 - 1
89-129
NC, IL, IN
OR
NW
CO
MA, OR, WI
OR
Nationwide
CA,NW
CA
CA
Nationwide
Nationwide
	
NC, OR
OR
NW
OR, OH
N/A

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Percent of Various U.S. Crops Treated Annually with Dichlobenil, 1993 - 1995
Site/1
Acres
Grown/2
(000)
Acres
Treated/3
(000)
Percent
Crop
Treated
Pounds AI
Applied
(000)
Major Region or
State
Non-agricultural Sites
Aquatic*
Homeowner
Sewers
Under asphalt
Rights of ways
Hedge/fence rows
Non ag Totals
Aggregate Totals
..
	
	
	
	
—
N/A
N/A
<1 - 1
10- 15
<1 - 1
<1 - 1
1 -2
1 -5
15-25
57-94
..
	
	
	
	
—
N/A
N/A
4-8
40-50
5- 10
5- 10
5-10
5- 10
64-98
153 -227
CA,FL
NW
Nationwide
West
NW
Midwest
N/A
N/A
     — Unknown
     /I - Site identification based on REFS.
     /2 - Acres grown based on USD A, Agricultural Census, and state statistics.
     /3 - Multiple acres treated represents the total number of acre treatments.

     Data based on proprietary and non-proprietary sources, USD A, and state statistics.

     *   Dichlobenil is no longer registered  for nectarine,  peach,  plum, prune, lakes,  ponds,  or
     impoundments as well as clover, fig, mango, nuts (other than filberts) or citrus use sites.
     (Use deletion requests published in FR Notices dated 8/23/95, 11/1/95, 2/28/96, and 4/17/96.)

     Please note that cottonwood-poplar hybrid plantation use site information is not included in this table
     because this use was just recently registered and information about poundage used at this site is
     unavailable.
            D.     Data Requirements

     Data requested in the Registration Standard for Dichlobenil issued March,  1987 include studies on
     product  chemistry, toxicology,  ecological effects,  environmental fate,  and  residue  chemistry.
     Appendix B includes all data requirements identified by the Agency needed to support reregi strati on
     for currently registered uses.

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       E.     Regulatory History

Dichlobenil was registered in the United States in 1964 for use as a herbicide.  A Registration
Standard for dichlobenil was issued on March 23, 1987.  The Dichlobenil Registration Standard
required several studies including new  product chemistry data for the technical.  Analysis for
polychlorinated dibenzo-para-dioxins and dibenzofurans and nitrosamines was required because
dichlobenil is a polyhalogenated cyclic compound. A Data Call-In (DCI) was issued on June 9, 1987
requiring product chemistry data to assess the potential formation of halogenated dibenzo-p-dioxin
or dibenzofuran contaminants.  The Dichlobenil Product and Residue Chemistry Reregi strati on
Standard Update was issued 7/31/91, and required additional product chemistry data,  as well as
analyses for dioxins and nitrosamines for the Solvay Duphar 99.5% technical and 85% formulation
intermediate. DCIs were issued November 22,  1993  for dichlobenil requiring data to assess: toxicity
to estuarine organisms, dermal toxicity and exposure, volatility, spray drift, and magnitude of residues
in  potable  water,  fish,  irrigated  crops   and  cherries;   in  March   17,  1994   to  assess
mixer/loader/applicator exposure; and on October 18, 1995, a DCI was issued for re-entry exposure
data. This Reregistration Eligibility Decision reflects  a reassessment of all data which were submitted
in response to the Registration Standard and subsequent DCIs.

The basic producer of the dichlobenil technical is Uniroyal Chemical Company.  Their technical
registrations  (EPA Reg. No. 400-175 and 400-462) were previously held  by Solvay Duphar.
However, on July 10, 1995 the Agency accepted the transfer of all Solvay  Duphar products to
Uniroyal Chemical.  FBI Gordon's technical registration (EPA Reg. No. 2217-680) is repackaged
from a Uniroyal product, and therefore is not subject to additional generic data requirements.

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III.    SCIENCE ASSESSMENT

       A.     Physical Chemistry Assessment

Description of Chemical

Dichlobenil (2,6-dichlorobenzonitrile) is a selective herbicide.

                                            CN
                                      did
Empirical Formula:  C7H3C12N
Molecular Weight:  172.0
CAS Registry No.:  1194-65-6
ShaughnessyNo.: 027401
Identification of Active Ingredient

Dichlobenil is a white crystalline solid with a melting point of about 144°C.  The vapor pressure of
dichlobenil is  0.088 Pa at 20°C.  At 25°C, technical dichlobenil is practically insoluble in water
(0.0021 g/100 ml) and slightly soluble in most organic solvents (i.e., 5.3 g/100 ml in xylene, 1.5 g/100
ml in ethanol, and 0.37 g/100 ml in cyclohexane).  Dichlobenil is stable at elevated temperatures and
in acidic media.

Manufacturing-use Products

There are six dichlobenil manufacturing-use products (MPs), all of which were registered before the
Dichlobenil Reregi strati on Standard issued 3/23/87.  A list of the dichlobenil MPs subject to a
reregistration eligibility decision is presented in Table  1 below.

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Table 1: Dichlobenil MPs
Formulation
99% T
85% FI
99% T
85% FI
99% T
85% FI
EPA Reg. No.
400-175
400-176
400-462
400-463
2217-680
2217-677
Registrant
Uniroyal Chemical Company, Inc.
FBI/Gordon Corporation
The registrations for the 400-462 and 400-463 were previously held by Solvay Duphar. However,
on July 10, 1995 the Agency accepted the transfer of all Solvay Duphar products to Uniroyal
Chemical. Currently, there are two technical products for dichlobenil, a 99% T (EPA Reg. No. 400-
175) and a 99% T (EPA Reg No. 400-462). The 99%T was originally a Duphar product (EPA Reg.
No. 37100-4). EPA Registration 400-175 was a re-package of 37100-4.

Solvay Duphar submitted all new  product chemistry data including dioxin and furan analyses in
support of a new manufacturing process. None of the 15 target analytes were found at or above the
specified levels of quantification (LOQs). Therefore, the requirements to analyze technical dichlobenil
for dioxin and furans have been fulfilled.

Revised Confidential Statements of Formula (CSFs) for 400-175 and 400-462 were submitted for
review.  The revised CSFs are adequate. The CSF refers to the product as technical dichlobenil
greater than or equal to 98%; the label claim should be the nominal  concentration 99% (refer to PR
Notice 91-2). No additional data are required for 61-1 and 62-2 for these products.

The FBI/Gordon 99% T and 85% formulation intermediate (FI) are repackaged from the Uniroyal
dichlobenil products; therefore, all  product chemistry data requirements for these products, except
for individual CSFs (GLNs 61-1 and 62-2), will be satisfied by Uniroyal (formerly Solvay Duphar)
data.

Generic and product-specific data remain outstanding for the dichlobenil MPs. Refer to Appendix
B for a listing of outstanding product chemistry data requirements.

The  product chemistry data  are based on currently available information.  With respect to the
reregistration of dichlobenil, the registrants must submit the chemistry data required for their products
and either  certify that the suppliers of starting materials and the  manufacturing  process for the
dichlobenil technical products and MPs have not changed since the last comprehensive  product
chemistry review or submit complete updated product chemistry data packages.
                                           10

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       B.
       Human Health Assessment
              1.     Toxicology Assessment

The toxicological data base for dichlobenil includes studies performed with dichlobenil and studies
performed with 2,6-Dichlorobenzamide (BAM). Since BAM is the major residue in plants treated
with dichlobenil, and is consumed in the food supply, it was necessary  to perform toxicological
studies on BAM. A complete toxicology assessment of BAM follows the toxicology assessment of
dichlobenil.

                     a.     Acute Toxicity

The results of the acute toxicity profile of dichlobenil are summarized in the following table:


  Table 2: Acute Toxicity Values
GLN
81-la
81-2b
81-3°
81-4C
81-5°
81-6d
TEST
Oral LD,0 - Rat
Dermal LD,0 - Rabbit
Inhalation LC,0 - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation -Rabbit
Dermal Sensitization - Guinea pig
MRID
00112500
43250401
43335703
40425403
40425402
40548501
RESULT
4.25 g (M & F)
>2g/kg
> 3.3 mg/L
Not an ocular irritant
Not a dermal irritant
Not a skin sensitizer
TOXICITY
CATEGORY
III
III
III
IV
IV
N/A
b.
c.
d.
The a.i.% was not specified in the review. However, an acute dermal toxicity study (MRID 00113796) was
performed at the same time by the same laboratory.  It is assumed that the same concentration (90.7% T) was used
for both studies.
The 98.8% T was used.
The 85.3% formulation was used.
The 99.4% T was used.
An acute 4-hour inhalation test was performed using technical dichlobenil (98.8%). However, due
to clogging of the apparatus, the highest dose that could be tested was 0.25 mg/L.  Therefore, an
acute inhalation test was also performed using the 85.3% formulation. An LC50 in rats of
> 3.3 mg/L was obtained.  This result would normally place dichlobenil in Toxicity Category IV;
however, because the respirable particle size was less than optimal (5.5 jim instead of an optimal size
of 4  jim), Toxicity Category III was assigned as an added measure of protection.
                                             11

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                     b.     Subchronic Toxicity

The Agency is not requiring a subchronic non-rodent study. The toxicological data requirement for
a 90-day feeding study in non-rodents was satisfied by an acceptable two-year dog feeding study
(MRID 00067649).

In a 21-day dermal toxicity study, dichlobenil technical (98.8% a.i.) was administered topically to the
clipped dorsal region (intact skin) of New Zealand white rabbits (5/sex/dose) at daily dose levels of
0, 100, 300, or 1000 mg/kg/day for 6 hours per day for 3 weeks.  Administration of 100, 300 or 1000
mg/kg/day produced no clinical signs or skin irritation.  No animals died during the study.  There
were no treatment-related effects on body-weight, food consumption, hematology, blood chemistry,
organ weights, gross or microscopic pathology. The NOEL for dermal irritation and systemic toxicity
is equal to or greater than 1000 mg/kg/day, the highest dose tested. The LOEL is greater than 1000
mg/kg/day. (MRID 43879301).

Rats (12/sex/dose) were given dichlobenil in the diet for 13 weeks at doses of 0, 100,  1000, or 3000
ppm (0, 5, 50, 150 mg/kg/day). An additional group of 6 male rats was maintained on a 10,000 ppm
diet. Compound-related effects included increased absolute and relative liver and kidney weights at
1000 ppm and higher. There was also hepatic degeneration without significant necrosis at 3000 ppm
and higher, and mortality (5 out of 6) and hepatic necrosis  at 10,000 ppm. The NOEL was 5
mg/kg/day (100 ppm).  The LOEL was set at 50 mg/kg/day (1000 ppm) based on increased absolute
and relative liver and kidney weights. This study satisfies the requirement for a 90-day feeding study
in rats. (MRID 00107106).

In a 13-week oral toxicity test, mice were given dichlobenil  in the diet at concentrations of 0, 25, 125,
625, or 3125 ppm  ( 0, 4, 19, 95, or 473 mg/kg/day). Adverse effects in the liver (specific effects
were not reported)  were observed in female mice at the 95 mg/kg/day level. (This does not satisfy
the data requirements for any guideline study, no MRID)

In a 13-week oral toxicity test, hamsters were given  dichlobenil in the diet at concentrations of 0, 41,
209,  1289, or 4648 ppm ( 0, 3,  16, 79, or 263 mg/kg/day). At the beginning of the study, the high
dose was 7500 ppm.  However,  hamsters could not tolerate a diet of 7500 ppm dichlobenil (395
mg/kg/day); therefore, this dose was lowered to 4648 ppm during week 3. The NOEL for systemic
toxicity was 3 mg/kg/day.  The LOEL was set at 16 mg/kg/day based on decreased prostate weight
and prostatic degeneration and mineralization in males; and increased phospholipids, increased liver
weight as well as unspecified adverse liver effects in females. (These data were used as a range-
finding study for a  carcinogenic hamster study; MRTD 40600701)

                     c.     Chronic toxicity

Groups of beagle dogs (4/sex/dose) were given dichlobenil in the diet for 2 years at dosing levels of
0, 20, 50, or 350 ppm (0, 0.5, 1.25, or 8.75 mg/kg/day). The NOEL for systemic toxicity was 1.25
mg/kg/day. The LOEL for systemic toxicity was 8.75 mg/kg/day based  on (1) an increase in absolute
                                            12

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and relative liver and thyroid weights in both sexes; (2) an increase in serum alanine aminotransferase
in females, and serum alkaline phosphatase in both sexes; (3) an increase in liver enzyme glucose-6-
phosphatase and glucose-6-phosphatase dehydrogenase activity  in both sexes; and (4) leucocytic
infiltration  and fibrinoid degeneration around the central hepatic veins  of both sexes.   (MRID
00067649)

In another chronic  study groups of dogs were given dichlobenil by capsule.  This study (MRID
43969701) was not  required by the Agency; but was required by California. A preliminary review
of the study indicates that the results are substantially similar to that of MRID 00067649. This study
has not yet been fully reviewed because the study demonstrates substantially similar results, and the
RfD for dichlobenil  is not used in the risk assessment of this RED.
                     d.      Combined Chronic/Carcinogenicity

Hamsters were selected as a test species based on studies of mice and hamsters indicating that female
was the most sensitive sex, and that female hamsters were about six times more sensitive than female
mice.

In the first study dichlobenil (technical grade, 99.4%) was given in the diet to groups of 50 male and
50 female hamsters for 80 weeks (females) or 88 weeks (males) weeks at doses of 0, 5, 26, 132, or
675  ppm, (0, 0.35,  1.78, 9.20, or 48.86 mg/kg/day in females and 0, 0.34, 1.69, 9.39,  or 45.64
mg/kg/day in  males).   There  were  an additional  50 hamsters/sex for  the  control group.
Histopathology was conducted upon completion of treatment.

Administration  of dichlobenil did not result in  an increase in tumor incidence in any tissue.  The
incidence of several non-neoplastic endpoints was significantly increased but did not increase with
increasing dose.

The NOEL for systemic toxicity was 9.20 mg/kg/day.  At 675 ppm in males, the incidences of islet
cell hyperplasia  of the pancreas, reduced secretion in the prostate and seminal vesicles, and acanthosis
of the skin were significantly increased above controls. At 675 ppm in females (1) the incidences of
centrilobular hepatocyte enlargement and rarefaction in the liver, (2) cortical hyperplasia of the
adrenals, (3) epithelial hyperplasia of the stomach,  (4) hyperplasia of bone marrow in the sternum,
(5) submucosal inflammatory cells in the stomach, (6) peritonitis, (7) prominent mucous cells in the
cecum,  (8) luminal dilation  of the rectum,  and (9) hyperkeratosis of the skin were significantly
increased  above controls.  Thus,  the LOEL was set at 45.64 mg/kg/day (MRTDs 41988301,
42015101).

In a second carcinogenicity  study, dichlobenil  (technical grade, 99.4%) was  given in the diet to
groups of 50 male  and 50 female Bio FID Alexander Syrian hamsters for seventy-eight weeks
(females) or ninety-one weeks (males) at doses of 0, 675, 1500, and 3375 ppm (0, 55, 121, or 277
                                            13

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mg/kg/day for females and 0, 51,  117, or 277 mg/kg/day for males). There were an additional 50
hamsters/sex for the control group. Histopathology was conducted upon completion of treatment.

There was one benign liver tumor in a male dosed at 1500 ppm.  In the male hamsters dosed at 3375
ppm, there was a statistically significant increase in benign liver cell tumors.  One malignant liver cell
tumor was observed in a male dosed at 3375 ppm. At all doses, a significant increase in relative liver
weight and a  significant decrease in body weight gain in male and female hamsters were observed.
Based on this, a systemic toxicity NOEL was not observed in this study. At the 675 ppm dosing level
in males, the incidences of centrilobular hepatocyte enlargement and pigmented alveolar macrophages
of the lung were significantly increased above controls. Thus, the LOEL was set at 51 mg/kg/day
based on decreased body weight  gain in both sexes, as well as increased relative liver weight in
females.

At the  1500 ppm dosing level,  the incidences  of centrilobular hepatocyte enlargement, finely
vacuolated hepatocytes, and brown pigment in hepatocytes (males) and hepatitis  (females) were
significantly increased above controls.

At the 3375 ppm dosing level in males, the incidences of centrilobular hepatocyte enlargement, finely
vacuolated hepatocytes, hepatitis, pigmented giant cells and  sinusoidal cells  in the  liver, brown
pigment in hepatocytes, and eosinophilic hepatocytes were significantly increased above controls.
There were incidences of pigmented alveolar macrophages of the lung, pigmented macrophages in
the  rete  testes, and dilated seminiferous tubules  which were also significantly increased above
controls.

At the 3375 ppm dosing level in females, the incidences of centrilobular hepatocyte enlargement,
hepatitis, and pigmented giant cells and sinusoidal cells in the liver were significantly increased above
controls.  Incidences of hyperplasia of the urothelium of the urinary bladder, microcysts of the
pituitary, glandular tissue in the  muscularis of the stomach (also with inflammatory  cells), and
mucosal inflammation of the cecum were also significantly increased above controls.   (MRTDs
42221201, 42563601)

Dichlobenil (96.7%) was given in  the diet to groups of Fischer 344 rats (50 male and 50 female) at
dosing levels of 0 (control), 50, 400 or 3200 ppm for 2 years, (0, 2.3, 18.9, or 173.1 mg/kg/day,
respectively).  The NOEL for systemic toxicity was 2.3 mg/kg/day.  The LOEL for systemic toxicity
was set at 18.9 mg/kg/day based on: (1) renal damage in males characterized by increases in water
consumption, cholesterol, blood urea  nitrogen,  creatinine, urinary glucose, urinary  bilirubin,
nephrosis, parathyroid hyperplasia (with associated osteodystrophy and metastatic calcification), and
relative and absolute kidney weight; (2) liver effects including  increased relative and absolute liver
weights in males and females; and (3) increased  cytological alteration (the appearance of nuclear
pleomorphism combined with swelling of the liver cells) in females.

There was an increased incidence in hepatocellular tumors at the high dose in both sexes.  In female
rats there were statistically significant increases by pair wise comparison in adenomas and combined
                                            14

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adenomas/carcinomas.  There were  also statistically significant positive dose-related trends for
adenomas and carcinomas, alone and combined. In male rats there were also statistically significant
positive trends for adenomas and carcinomas alone and combined, but there were no statistically
significant increases by pairwise comparison in any tumors at any dose. These tumors are considered
to be unusual but not rare (<1%) in F344  rats.  Tumors  did not appear to occur with decreased
latency.  (MRID 00147438)

                    e.     Developmental Toxicity

Groups of 25 Wistar rats were treated by gavage during gestation days 6 through 15 with 0 (control),
20, 60, or 180 mg/kg/day of dichlobenil. Animals were sacrificed on gestation day 21, and examined
for live fetuses and intra-uterine deaths. Fetuses were weighed and examined for external visceral
and skeletal alterations.  The maternal NOEL was set at 20 mg/kg/day and the LOEL was set at 60
mg/kg/day based on decreased maternal body weight gains, and decreased food consumption. The
developmental NOEL and LOEL values were set at 60 mg/kg/day and 180 mg/kg/day, respectively,
based on an increase in the incidence of supernumary thoracic ribs that is statistically significant at
the 180 mg/kg/day dose level. (MRID  00147437)

New Zealand White rabbits were given dichlobenil  by gavage at dosing levels of 0,  15, 45, or 135
mg/kg/day during gestation days 7 through 19.  At 135 mg/kg/day, a significant decrease in body
weight gain and food consumption was noted in does during the dosing period. Consequently, the
maternal NOEL and LOEL values were 45 and 135 mg/kg/day, respectively.

At 135  mg/kg/day,  developmental  toxicity  was  manifested as increased incidences of  post-
implantation loss and late resorptions, and the occurrence  of major external (cleft palate, adactyly,
and eye anomalies), visceral (anomalies of vascular system), and skeletal (misshapen frontals, enlarged
fontanelle and fused sternebrae) defects.  Consequently, the developmental NOEL and LOEL values
were set  at 45 and 135 mg/kg/day, respectively. (MRID 41257302).
                    f.     Reproductive Toxicity

Dichlobenil at dietary levels of 0, 60, 350, and 2000 ppm (0, 3, 17.5, and 100 mg/kg/day) was given
to groups of Sprague-Dawley rats (30/sex/dose for FO and 25/sex/dose for Fl) for two generations.
The parental NOEL was 17.5 mg/kg/day.  The parental LOEL was set at 100 mg/kg/day based on
significant decreases in body weight, body weight gain, and food consumption in males and females
from both generations. The reproductive NOEL was 3 mg/kg/day.  Reduced pup body weights were
observed at both the 17.5 and 100 mg/kg/day  levels; therefore, the reproductive LOEL was 17.5
mg/kg/day.  A significant decrease in birth weight of the Fl pups was observed at 17.5 mg/kg/day.
This decreased mean Fl  pup weight occurred in the absence of maternal toxicity, but did not present
a clear dose response relationship. The effect  was not repeated in the second generation. At the
same dietary level, the mean body weight of the F2 pups was greater than the mean body weight of
the control pups at birth. (MRIDs 41257303, 42239101)
                                           15

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                    g.     Mutagenicity

The following studies did not demonstrate any mutagenic potential for dichlobenil.

In the Ames test, there was no apparent mutagenic potential in Salmonella typhimurium strains TA-
1535, TA-1537, TA-1538, TA-98, and TA-100 at dosing levels of 0, 40, 200, or 1000 //g/plate, both
with and without S-9 activation systems. At 5000 //g/plate, the highest dose tested (HDT) the test
compound precipitated.  (MRID 00153579)

There was no apparent mutagenic potential up to 5000 jig/disk, HDT, in the B. subtilis H-17 and H-
45 strains without activation and up to 5000 //g/plate in the E.  coli (WP2) and S. typhimurium strains
TA-1535, TA-1537, TA-1538, TA-98, and TA-100 both with and without S-9 activation systems.
(MRID 00153586)

In an in vitro mouse lymphoma (L5178Y TK+/-) test system, there was no apparent mutagenic
potential up to 280 //g/ml without activation and 50 mg/ml with activation. (MRID 00153576)

In an in vitro chromosomal aberrations test with metaphase analysis using human lymphocytes, there
was no apparent mutagenic potential up to 1 //g/ml (the highest soluble concentration) both with and
without activation. (MRID 00153577)

An unscheduled DNA synthesis (UDS) in vitro test using human HeLa epithelioid cells assaying for
DNA repair in response to DNA damage was performed. There was no apparent mutagenic potential
from 0.05 to 102.4 //g/ml both with and without S-9 activation.  (MRID 00153580)

There was no apparent transforming potential up to 7500 //g/ml with activation in  the BALB/3T3
transformation assay. The transforming potential of dichlobenil without activation was not assessed.
(MRID 00153581).

Chinese hamster ovary (CHO) cells were exposed to dichlobenil at dosing levels up to  100 //g/ml both
with and without S9 activation. Cultures with the S-9 activation were exposed for  10 or 20 hours.
Those  without the S-9 activation were exposed for 20 or 30 hours. Dichlobenil was negative for
inducing structural chromosome aberrations. (MRID 41319101)

                    h.     Metabolism

These studies collectively provide adequate information on the pharmacokinetics and metabolism of
dichlobenil. (MRID 41227404)

Single doses of 5 mg/kg [phenyl-U-14C] dichlobenil were given to male and female SD rats by either
intravenous (iv) or oral administration.  Urine and feces were collected at various intervals after
dosing. Seven days after iv administration male rats had excreted 70.7% of the dose in the urine and
                                           16

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25.4% of the dose in the feces. Total recovery was 96%. In females, 65.1% and 30.9% of the dose
were excreted in the urine and feces, respectively.  Total recovery was also 96%. Similar results were
obtained 7 days after oral administration. Males excreted 65.1% and 19.2% of the dose in urine and
feces, respectively.  Total recovery was 84%. Females excreted 64.9% and 20.7% of the dose in
urine and feces, respectively. Total recovery was 86%.  Thus, the total recoveries following iv dosing
were  slightly higher than those following oral  dosing.  The rate of urinary excretion was  rapid;
excretion  was 95% complete in 24 hours. The similarity in total excretion pattern after either an
intravenous or oral dose indicates that dichlobenil at the 5 mg/kg dose is readily absorbed from the
gastrointestinal tract.

In addition, three bile duct-cannulated male  rats were dosed orally  with 5 mg/kg  and bile was
collected  2, 5, and 24 hours after administration.  For these three rats, 78.9% of the administered
dose was recovered in the bile and 19.8% in  the urine 24 hours after administration.   (MRTD
41227401)

A similar  study using single doses of 2.5 mg/kg [phenyl-U-14C] dichlobenil given orally was also
performed. Radioactive residue levels in various tissues were assayed in two rats/sex at various post-
dosing intervals. The results indicate that residue levels decreased with time after dosing.  (MRTD
41227402)

In another study  [phenyl-U-14C] dichlobenil in single or multiple doses at dosing levels of 3.75, 30,
or 240 mg/kg were given orally.  The radiolabeled dichlobenil was given as a single dose on day 1
in one study and on day 1 and day 11 in a multiple-dose study, with rats  receiving unlabeled test
material on days 2 to 10. Rats receiving a single dose of radiolabeled dichlobenil excreted 55% to
69% of the dose in the urine and 15% to 20% in  the feces. Total recoveries at the two lower doses
were between 89% and 92%. At the highest dose, total recoveries accounted for 77% to 83%  of the
dose.  There were no significant sex-related differences.  Similar elimination patterns were  noted
following  the administration of radiolabeled dichlobenil on day 11.

Although  some saturation kinetics were noted at the high dose, there were no major differences
related to  sex or dosing regimens.  The great similarities in the percentage excretions for the three
dosing levels indicate that dichlobenil administered orally up to the high-dose levels was readily
absorbed by the rats. Tissue residue levels were dose-dependent. The highest residue levels were in
the liver in the rats receiving the highest dose  tested.  (MRID 41299401)

The metabolic profiles from the above studies were analyzed, and the metabolites identified. Nine
metabolites were found in the urine.  Four were found in the feces. The major metabolites found in
both urine  and feces were 2,6-dichloro-3-hydroxybenzonitrile and its sulfate conjugate; 6-chloro-3-
hydroxy-2-cysteinyl-benzonitrile; and 6-chloro-2-cysteinyl-benzonitrile.  Based on the metabolites
identified, two metabolic pathways were proposed: (1) hydroxylation at the 3 or 4 position  of the
phenyl moiety followed by sulfation or glucoronidation and (2) conjugation with glutathione through
displacement of the chlorine atom. (MRID 41227403)
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                    i.      Dichlobenil Toxicological Endpoints of Concern Identified for
                           Use in Human Risk Assessment

Acute
A NOEL for use in calculating an acute (1 day) dietary risk assessment due to consumption of
dichlobenil was identified. The NOEL from a rabbit developmental toxicity study (MRID 41257302)
was 45 mg/kg/day.  The  developmental  LOEL was set at 135 mg/kg/day  based  on  increased
incidences  of post-implantation loss and late resorptions, and the occurrence of major external,
visceral, and  skeletal defects from the rabbit development toxicity study.  However, the residue
chemistry data indicate that dichlobenil per se  is not consumed in food; therefore, use of the
dichlobenil acute dietary NOEL in the food source risk assessment would be inappropriate. Data
indicate that dichlobenil is found in water therefore, an acute risk assessment for drinking water may
be appropriate.

Short term
A short term (1-7 days) occupational or residential risk assessment is required based on  a rabbit
developmental toxicity study. The developmental NOEL is 45 mg/kg/day.  The developmental LOEL
was set at  135 mg/kg/day based on increased incidences of post-implantation loss and late
resorptions, and the occurrence of major external, visceral, and skeletal defects from  the rabbit
developmental toxicity study.

Intermediate
An intermediate term (1 week - several months) occupational or residential risk assessment is required
based on a 2 generation reproduction study of Sprague-Dawley rats. The NOEL is 3 mg/kg/day.
The LOEL was set at 17.5 mg/kg/day based on decreased pup body weight. Supporting this selection
are a 2-year dog study with a NOEL of 1  mg/kg/day and a 90-day rat study with a NOEL of 5
mg/kg/day.

Chronic
The OPP Cancer Peer Review Committee (CPR) met on March 15, 1995, and determined that the
available evidence for dichlobenil constituted only limited evidence for carcinogen!city and classified
dichlobenil as a Group C, possible human carcinogen.  The CPR Committee also concluded that a
quantitative estimation of risk was not appropriate at that time, because the increases in hepatocellular
tumors were statistically significant in only one sex  (females); the tumors were predominantly benign
adenomas, and supporting evidence was weak, at best.  Although the tumor type (hepatocellular) is
considered unusual for this strain of rat, tumors did not occur to an unusual degree or with an early
onset.

The OPP RfD Committee met on March 31,  1994, and determined that the RfD for dichlobenil was
0.013 mg/kg/day. The RfD was based upon a NOEL of 1.25 mg/kg/day from a two-year dog feeding
study (MRID 00067649) using an uncertainty factor (UF) of  100 to account for  inter-species
extrapolation and intra-species variability. The LOEL for systemic toxicity was  8.75 mg/kg/day based
on:
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       (1) an increase in absolute and relative liver and thyroid weights in both sexes;
       (2) an increase in serum alanine aminotransferase in females, and serum alkaline phosphatase
       in both sexes;
       (3)  an  increase  in liver  enzyme glucose-6-phosphatase  and  glucose-6-phosphatase
       dehydrogenase activity  in both sexes; and
       (4) leucocytic infiltration and fibrinoid degeneration around the central hepatic veins of both
       sexes.

The RfD is the traditional  endpoint for calculating chronic dietary  risk.  However, the residue
chemistry data indicate that dichlobenil per se is  not consumed in food; therefore, use of the
dichlobenil RfD in the food source dietary risk assessment would be inappropriate.  Data indicate that
dichlobenil is found in water therefore a chronic assessment for drinking water may be appropriate.
Dichlobenil has not been evaluated by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR).

Toxicity Data for the Dichlobenil Metabolite 2.6-Dichlorobenzamide (BAM)

The BAM metabolite is the major residue detected in plants. It is not an animal metabolite. It was
necessary to perform toxicological studies on BAM since it is consumed in the food supply.


                    j.     Acute Toxicity of BAM

The acute oral LD50 of BAM in mice is 1538 and 1144 mg/kg in males and females, respectively, and
falls in Category III. (MRID 42940201)


                    k.     Subchronic Toxicity of BAM

BAM was given to Wistar rats (10/sex/dose) for 13 weeks at dietary levels of 0, 50,  180, 600 or 2300
ppm.  The NOEL for systemic effects was set at 180 ppm (14 mg/kg/day) and the LOEL was set at
600 ppm (49 mg/kg/day) based on decreased body weight gain and food efficiency, increased blood
urea nitrogen, and reduced coagulation times (MRID No. 00067654).

                    1.     Combined Chronic Toxicity/Carcinogenicity  Study of BAM

BAM was given to Crl  CD rats (35/sex/dose) for 106 weeks at dietary levels of 0, 60, 100, 180 or
500 ppm ( 0, 2.2, 3.6, 6.5, or 19 mg/kg/day in males; 0, 2.8, 4.7, 8.5, or 25 mg/kg/day in females).
The NOEL was 6.5 mg/kg/day.  The LOEL was  set at 19 mg/kg/day based  on a statistically
significant decrease in mean body weight gains in both males and females (10% and 20% less than
controls, respectively, at week 52); and minimum histologic changes (slightly increased severity of
fat deposition) in the livers of females. BAM produced an increased incidence of hepatoma in females
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at 500 ppm (14%; vs. 0% at 60 and 100 ppm; 3% at 180 ppm). As part of the Agency's review,
clarification of the tumor types and data on the stability/homogeneity of the test compound was
requested. This information was submitted. With this additional data from reclassified liver slides,
the Agency determined that the high dose female rats  demonstrate  an increased incidence of
adenomas (14%) which was of borderline significance (p< 0.049).

Both of the previously identified deficiencies have been satisfied.  However, a peer review of the re-
read of the liver slides has not been submitted.  Therefore,  The study was classified as Core
Supplementary  and therefore  does  not  satisfy  the  guideline requirement  for a  chronic
toxicity/carcinogenicity study in rats.  To upgrade the chronic toxicity/carcinogenicity study to Core-
minimum the Agency requests that Uniroyal submit peer review results of the histopathological
examination of livers from rats.  Before a formal determination can be made on the carcinogenic
potential of BAM, peer review results of the histopathological  examination of livers from the rats
need to be submitted, and these data along with available BAM chronic toxicity/ carcinogenicity need
to be evaluated by the Cancer Peer Review Committee (CPRC).

This rat chronic toxicity/carcinogenicity study suggests that the chronic systemic toxicity of BAM in
rats  does  not  exceed (and may be lower) than that of its parent compound, dichlobenil.  The
carcinogenic potential of BAM also appears to be less than or equal to that of dichlobenil.  (MRTD
00147438, 40401101, 40823801, 42940202, 43747100, 44052901, 44043601).  (Dichlobenil has
been classified as a group C, possible human carcinogen with a recommendation for quantification
using an RfD approach.)  This result is also consistent with the chronic toxicity data (MRTD
00066983) in beagle dogs.

In a chronic toxicity study in dogs, BAM was fed to beagle dogs 4/sex/dose for two years at dietary
levels of 0 (control), 60, 100, 180, or 500 ppm (0, 1.5, 2.5, 4.5, or 12.5 mg/kg/day). The NOEL was
4.5 mg/kg/day. The LOEL was set at 12.5 mg/kg/day based on decreased body weight gain in males
(38% less than controls at 2 years) and in females (61% less than controls at 2 years).

The dog study has been classified as Core Supplementary and therefore does not satisfy the guideline
requirements for a chronic toxicity study in non-rodents.  However, the study is upgradable to Core
Minimum upon submission of diet stability and homogeneity data.  The registrant has notified OPP
of its intent to conduct a retrospective stability /homogeneity study.) Numerous other study
deficiencies were noted which would not affect the study's acceptability for regulatory purposes.
(MRID 42940203, 43747100)

                    m.    Developmental  Toxicity of BAM

Sixteen New Zealand white rabbits per dose group were given BAM at dosing levels of 0, 10, 30, or
90 mg/kg/day by oral gavage on gestational days (GDs) 7-19. Maternal toxicity was observed at
30 and 90 mg/kg/day.  At 30 mg/kg/day, moribund!ty increased (2  animals vs 0 in the control). At
90 mg/kg/day, moribundity  increased (2  animals vs  0  in the control); body weight decreased
nonsignificantly (93%-95% of control) on GDs 13 - 19; weight gain decreased significantly during
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the dosing period; food consumption decreased significantly (51% of controls) during the dosing
period; and the number of abortions increased (3 animals vs 0 in the control). Compensatory body
weight and food consumption increases above controls were noted during the post-dosing period.
The maternal NOEL was set at 10 mg/kg/day, and the LOEL was set at 30 mg/kg/day.
Developmental toxicity was observed  at 90 mg/kg/day.  It was manifested as a nonsignificant
decrease (94% of controls) in fetal body weight which was outside the historical control range.
Consequently, the developmental toxicity NOEL was  set at 30 mg/kg/day. The developmental
toxicity LOEL was set at 90 mg/kg/day based on decreased fetal body weight and body weight gain.
(MRIDs 43003601, 43265201)

                     n.     3-Generation Reproduction Study of BAM

Results of a reproduction study of rats fed diets containing BAM over three generations (MRTD
42940204) were submitted.  However, the study was not reviewed. The registrant has been unable
to locate the individual animal data requested by the Agency.  However, another rat reproduction
study has not been required because of the following reasons: (1) Cursory review of the results of the
submitted 3-generation reproductive study of BAM in rats (MRTD 42940204) showed that the
reproductive toxicity of BAM at 180 ppm was mainly manifested as a significant decrease in pup body
weight (83-86% of the control animals at day  21  only  for 1 and  3  generations, but not in 2
generation) (2)  Decrease in pup body weight (90-94% of the control animals at days 14 and 21 for
both generations) at  350  ppm was also seen in a 2-generation reproductive study of its  parent
compound,  dichlobenil in rats. (3) The toxicity of BAM is not greater than that of its  parent
compound, dichlobenil, based on the results of chronic toxicity studies of BAM and its parent in rats
and dogs.

                     o.     Mutagenicity of BAM

BAM was negative for inducing reverse gene mutation (his- to his+) in TA strains of Salmonella
typhimurium exposed, in the absence and presence of mammalian metabolic activation (rat S9 mix),
up to 5000 //g/plate (MRID 43003603).

BAM was negative for inducing repair of DNA damage as measured by unscheduled DNA synthesis
(UDS), as determined by net nuclear silver grain count in primary rat hepatocytes, exposed up to
cytotoxic doses (1000 //g/ml) (MRID 43003604).

A mouse micronucleus assay using a single dose of BAM (250 mg/kg) was negative. This dose was
selected based on a single dose study in which the group of mice treated at 250 mg/kg displayed mild
neurotoxic effects (lethargy  and ataxia), the group  treated  at 500 mg/kg were  severely affected
(becoming comatose), and the groups treated at 1000 mg/kg and higher died in extremis. Thus, the
study is consistent with the guideline requirements of dosing animals up to levels producing either
clinical toxicity or cytotoxicity in target cells.  (MRID 43003602, 43747101)

Taken together, these studies satisfy mutagenicity guideline requirements.
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                    p.     BAM Toxicological Endpoints of Concern Identified for Use in
                           Human Dietary Risk Assessment

Acute
For BAM an acute (1 day) dietary risk assessment is not required because the time period in which
effects were noted in the rabbit developmental toxicity  study exceed a one day dosing period (MRID
43003601, 43265201). The developmental toxicity NOEL is 30 mg/kg/day.  The developmental
toxicity LOEL is 90 mg/kg/day based on a non-significant decrease in fetal body weight which was
outside the historical range. The maternal toxicity NOEL is 10 mg/kg/day. The maternal toxicity
LOEL is 30 mg/kg/day based on increased moribundity.  However, effects at the 90 mg/kg/day dose
level occurred on gestation days (GDs) 13-19 which is the  second half of the dosing period of GDs
7-19.  Thus,  the  Toxicological Endpoint Selection Committee concluded that it would be
inappropriate to use these endpoints for an acute assessment.

Short-term and Intermediate
Neither a short term (1-7 days) or an intermediate term (1 week - several months) occupational or
residential risk assessment is required. As previously stated, BAM is major residue detected in plants.
A scenario in which BAM is applied in either an occupational or a residential setting has not been
identified. Dichlobenil is the chemical applied by agricultural workers.

Chronic
The OPP RfD Committee met on July 27,  1995, and determined that the RfD for BAM was 0.015
mg/kg/day. The RfD was based upon a NOEL of 4.5 mg/kg/day from a 2 year dog feeding study
(MRID 42940203) using an uncertainty factor (UF) of 300 (100 x 3).  The 100 is to account for
inter-species extrapolation and intra-species variability. The 3 is to  compensate for the lack of an
acceptable reproduction study.  (The LOEL was  12.5 mg/kg/day based on decreased body weight
gain in both males and females). The RfD for BAM shall be used in the  total dietary (food source and
drinking water) risk assessment since plant residue studies indicate that BAM is the major residue
detected in plants and environmental fate data indicate BAM has the potential to leach into ground
water. BAM is consumed in the food supply and is therefore the chemical of concern.

Although a formal determination has not yet been made regarding the potential carcinogenicity of
BAM, a preliminary review of the data indicate that the potential does not exceed (and may be lower)
than that of the parent compound (currently classified as an unquantified, Group C, carcinogen).

             2.     Exposure Assessment

                    a.     Dietary Exposure

Tolerances for residues of dichlobenil in/on raw agricultural commodities are currently expressed in
terms of combined residues of dichlobenil and its metabolite 2,6-dichlorobenzoic acid (2,6-DCB A)
per 40CFR180.231.  The  established tolerances are each 0.15 ppm for plant  commodities.  No
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tolerances have been established for animal commodities and no tolerances for processed food/feed
have been established.

On June 8, 1992, the OPP Metabolism Committee met and concluded that 2,6-dichlorobenzamide
(BAM) is the major terminal residue of dichlobenil in plants, and should be added to the tolerance
expression.  Because dichlobenil plant metabolism studies demonstrate that 2,6-DCBA is not a plant
metabolite, the Committee has recommended removing 2,6-DCBA from the tolerance expression for
dichlobenil. Therefore, residue data for 2,6-DCBA are no longer required. All conclusions specified
here regarding the status of residue chemistry data requirements and the adequacy of the established
tolerances reflect the Metabolism Committee's determination to add BAM to the tolerance expression
and remove 2,6-DCBA from the tolerance expression.
The chemical structures of dichlobenil and its current metabolite of concern, BAM, are depicted in
Figure A.

	Figure A. The Chemical Structures of Dichlobenil and BAM	
                    Structure
            Parent:  Chemical name
          Structure
 Metabolite: Chemical name
                       CN
                                                                      NH
      dichlobenil:  2,6-dichlorobenzonitrile
BAM: 2,6-dichlorobenzamide
Plant Metabolism

The qualitative nature of the residue in plants is adequately understood based on acceptable plant
metabolism studies on apples and grapes. Both studies indicate that the major residue of concern is
BAM; the parent compound, dichlobenil, was not detected in either of the studies.  The OPP
Metabolism Committee has concluded that the  residues to be regulated in plant commodities are
dichlobenil and BAM.

In the grape metabolism study, mature grape vines were treated with a single soil  application of
uniformly benzene-ring labeled [14C]dichlobenil at a rate equivalent to Ix.  HPLC analyses of the
organosoluble and acid-hydrolyzed aqueous extracts indicated that BAM was the major residue,
amounting to 82.1% of the total radioactive residues (TRR).  4-Hydroxy-BAM was also identified
as a residue at 1.9% of the TRR.
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In the apple metabolism study, an apple tree was treated with a single soil application of uniformly
benzene-ring labeled [14C]dichlobenil at a rate equivalent to Ix.  HPLC analyses of the organosoluble
extracts of the apples indicated that BAM was the major residue, amounting to 57% of the TRR. The
remaining TRR were insoluble or unidentified soluble fractions, individually accounting for <0.01
ppm.

Animal Metabolism

Dichlobenil poultry and goat metabolism studies which had initially been judged inadequate, due to
the failure to account for nonextractable residues and substantial losses of radioactivity prior to HPLC
analyses, were later accepted when the plant metabolism studies indicated that dichlobenil is not a
significant plant residue. However, BAM, the major terminal residue in plants, was not found as a
metabolite or transitory intermediate in the ruminant or  poultry  studies. Therefore, additional animal
metabolism studies in which ruminants and poultry dosed with [14C]BAM were conducted.

Lactating goats were  dosed with [U-phenyl]14C-BAM at a dose level of 10 ppm for five days. The
maximum reasonable dietary burden is 0.5 ppm, based on a diet of 40% wet apple pomace and
assuming a 0.5 ppm  tolerance for apples, which is the  reassessed tolerance. The primary residue
found in milk, kidney, fat, and muscle was unchanged BAM.  The major residue found in liver was
the  glutathione conjugate  6-chloro-3-hydroxy-2-mercaptobenzamide.    Although,  additional
information is required to upgrade this  study, the available information is sufficient to assess dietary
exposure.

Laying hens were  dosed with [U-phenyl]14C-BAM at a dose level of  10 ppm for five days. The
primary residue found in all matrices collected was unchanged BAM. As a result of recent revisions
to Table 1 in OPPTS Guideline 860.1000 (August, 1996),  no significant poultry feed items  are treated
with dichlobenil. Therefore,  secondary residues in poultry are no longer of concern.

Residue Analytical Methods - Plants and Animals

PAM Vol. n, Method A is a GLC/ECD method with a detection limit of 0.05 ppm, which can be used
for  determination of residues of dichlobenil  in/on plant commodities.  This method was judged
adequate for tolerance enforcement; however, Method A uses benzene as a solvent. The registrant
was required to revise the method or develop an alternative method using safer solvents. The revised
method (MRTD 43805301) is currently  under review. However, this method is not adequate and will
require additional modification before it can be accepted as a tolerance enforcement method.

The Dichlobenil Guidance Document required development of an analytical method for the detection
and quantitation of BAM in plant commodities.  The former basic producer, Solvay  Duphar,
submitted a GLC/ECD method (L 3-53-71) for determination of residues of BAM in/on fruits and
nuts.   This method has undergone a successful independent laboratory validation and has been
validated by the EPA Beltsville Analytical Chemistry Laboratory (ACL). However, a revised method
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incorporating ACL's comments must be submitted before the requirements for an analytical method
for BAM can be considered fulfilled.

Residue data for  dichlobenil  that were included in the Residue Chemistry Science Chapter were
collected using Method A of PAM, Vol. II or modifications thereof.  Dichlobenil  residue data
reviewed since issuance of the Science Chapter were collected using an adequate GLC/ECD method
(L 3-53-64). This method does not involve the use of any hazardous solvents.  All BAM residue data
submitted in support of dichlobenil reregi strati on were collected using method L 3-53-71.

Analytical methods for the determination of dichlobenil and BAM in meat, meat by-products, and
milk are required. Dichlobenil residues were tentatively identified in goat fat and muscle in the
ruminant metabolism study in which the test animals were dosed with the metabolite BAM. Unless
additional data are submitted which demonstrate  that dichlobenil was  misidentified, dichlobenil
residue data in livestock commodities will be required.  The Agency will use total radioactive residue
(TRR) data from  the  metabolism study  so that a  worst case risk assessment can be done in the
absence of these methods.

The FDA PESTDATA database dated 1/94 (PAM Vol I, Appendix I) indicates that dichlobenil is
completely recovered (>80%) using multiresidue methods PAM Vol. I Sections 302 (Luke method)
and 304 (Mills fatty food method), and has partial recovery  (50-80%) using Section 303 (Mills,
Onley, Gaither method).  The database also indicates that BAM is completely recovered (>80%)
using Section 302, and not recovered using Sections 303 and  304.

Storage Stability

Adequate storage stability data for BAM to support the submitted field residue and processing studies
are available.  Residues of BAM are stable during frozen storage at < 14°C in/on apples for 6  months;
grapes, grape wet and dry pomace, and raisin waste for 4 months; apple processed fractions for 3.5
months; cranberries for 3 months; peaches for 2 months;  blackberries, plums and raspberries for 1
month; and blueberries for 15 days. BAM residues declined approximately 35% in/on raisins during
storage for 79 days. In addition, BAM residues are stable during frozen storage in/on filberts for 1
month but decline 50% after approximately 4 months of storage.

Apple and grape processing studies remain outstanding. Samples from the outstanding processing
studies  should be analyzed  within  the interval  that BAM residues  are known to be stable;
alternatively, new supporting storage stability studies should be submitted. In addition, BAM field
residue data remain outstanding for cherries.  Storage stability data to support this study are required.

Provided that adequate supporting storage stability data for the parent, dichlobenil, are  submitted to
support the outstanding field residue data for cherries and grapes, and the outstanding processing
studies for apples, and grapes, no additional storage stability data will be required for dichlobenil.
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Storage stability data for livestock commodities are required to support the outstanding cattle feeding
study.  Intervals and conditions must reflect those utilized in the feeding study.

Magnitude of the Residue in Plants

All data for magnitude of the residue in plants have been evaluated and deemed adequate to reassess
the tolerances for the residues of dichlobenil in/on apples, blackberries, blueberries, cranberries,
filberts, pears (translated from apples), and raspberries (translated from blackberries). Adequate data
from field trials depicting combined residues of dichlobenil and BAM following treatment according
to the  maximum registered use pattern have been  submitted for apples, blackberries, blueberries,
cranberries, and  filberts.  Additional  data are required for residues of dichlobenil and BAM for
cherries and dichlobenil only for  grapes.

Crops Grown Solely for Seed
The  alfalfa and clover grown for seed sites have been cancelled.  Therefore, the residue data and
tolerance proposals  for alfalfa and clover  forage  and hay that were required  in the Dichlobenil
Guidance Document, dated 3/23/87, are no longer required.

Magnitude of the Residue in Processed Food/Feed

The reregistration requirements for magnitude of the residue in processed food/feed commodities are
not fulfilled for any  commodity. Processing studies have been submitted for apples, grapes, and
plums treated at Ix the maximum  seasonal rate. However, these studies were deemed unacceptable
because, in the case of apples and plums, the raw agricultural commodity used for processing did not
bear detectable residues  of dichlobenil or BAM  and, in the  case of grapes,  residues were not
determined in the raw agricultural commodity used for processing.   In addition, residues of
dichlobenil were not determined in the grape and plum  processing studies.  The grape and plum
studies indicate that concentration of BAM residues may occur since detectable residues were
detected in the processed commodities.

In a second processing study submitted for apples, no detectable residues of dichlobenil or BAM were
detected in apples that were treated at Ix. Consequently, the registrant conducted a processing study
with untreated apples that had  been spiked with BAM only.  Because apples were not spiked with
dichlobenil, concentration factors for the combined residues of dichlobenil  and BAM could not be
determined.

Preliminary data which have been submitted for apples and grapes indicate potential concentration
of BAM residues in grape pomace (wet and dry) and raisin waste.

Adequate processing studies depicting the concentration of the combined residues of dichlobenil and
BAM  in the processed commodities of apples and grapes bearing detectable residues remain
outstanding. Exaggerated application rates may be necessary to obtain detectable residues.
                                            26

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There are no registered uses of dichlobenil on citrus fruits, plums or figs. Therefore processing
studies are not required to determine the potential for concentration of the combined residues of
dichlobenil and BAM in citrus, plums and/or fig processed commodities.

Magnitude of the Residue in Meat, Milk, Poultry, and Eggs

Insufficient data are available to determine if tolerances for ruminant commodities are required.  A
cattle feeding study must be submitted whereby cattle are dosed with BAM. Total radioactive residue
(TRR) values from the ruminant metabolism study (goats fed 14"C BAM) will be used to conduct a
worst-case risk assessment in association with this RED. Poultry studies are not required since no
significant poultry feed items are treated with dichlobenil.

Magnitude of the Residue in Potable Water, Fish and Irrigated Crops

A dichlobenil  DCI issued 11/22/93 detailed the data requirements for these guidelines for aquatic
food/feed sites. Subsequently, all aquatic food crop uses for dichlobenil were  deleted.

Confined/Field Rotational Crops

Data requirements for these guidelines have been waived based on the results of a hydrolysis study.
A restriction against the planting of rotational crops, on which dichlobenil is not registered for use,
in treated soil within one year of application has been established.  However, rotation of crops is not
likely since dichlobenil is only registered for use on domestic orchard crops, grapes, and cane and
bush berries.  These are commodities which are not grown from seed each year, but are produced
from mature plants that remain in place for many years.

                     b.     Dietary Exposure (Water)

Available information indicates that dichlobenil has been detected in surface water and that both
dichlobenil and its metabolite BAM have the potential  to  leach  and persist in ground water.
Therefore, consumption of drinking water containing residues of dichlobenil and/or BAM is possible.

Very limited ground water monitoring data are available for dichlobenil and BAM; all from non-U.S.
sites.  While these data are consistent with the Agency's determination that these compounds have
the potential to contaminate ground water, they are not sufficient to estimate the levels at which
contamination would occur.  A drinking water monitoring study is being required through this RED
in order to determine the level at which contamination of ground water occurs for both the parent
dichlobenil and metabolite BAM. Currently, the Agency does not have adequate data to conduct an
exposure assessment for residues of BAM in drinking water.

In order to estimate concentrations of dichlobenil in drinking water, the Agency used GENEEC
(GENeric Expected Environmental Concentration) modeling.  This program estimates  expected
concentrations from a  few basic chemical parameters  and pesticide label application information.
                                            27

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GENEEC is a tier one model which uses a chemical's soil/water partition coefficient and degradation
half-life values to estimate runoff from a ten hectare agricultural field into a one hectare by two meter
deep pond.  GENEEC considers reduction in dissolved pesticide concentration due to adsorption of
pesticide to soil or sediment, incorporation, degradation in soil before wash off to a water body,
direct deposition of spray drift into the water body, and degradation of the pesticide within the water
body. GENEEC can only estimate a surface water concentration.

It should be noted that GENEEC was designed for use in ecological risk assessment. It should be
considered as a screen, since GENEEC  could substantially over-estimate the actual drinking water
concentrations.  However, preliminary indications are that if the pesticide is not an organophosphate
(OP), a carbamate, or a pyrethroid and  is not used in repeated applications, that GENEEC may be
an appropriate screening tool for acute drinking water exposure.

Since dichlobenil is not an OP, a carbamate, or a pyrethroid, and is not used in repeated applications,
use of GENEEC is appropriate.

The exposure estimates do not take into account reduction of dichlobenil residues at water treatment
plants. Treatment of ground water or surface water in a publicly owned water treatment facility
would reduce the concentration of any dichlobenil residues that were present and thus reduce the risk
to those individuals consuming treated water.  Aeration and agitation are used in most public water
supply systems to reduce the concentration of volatile compounds in the water.  Since parent
dichlobenil has a high potential to volatilize, the aeration process will remove some of the dichlobenil
in the raw water. It can not be determined if aeration and agitation will be effective in removing
BAM from the raw water. Filtration will also help to remove dichlobenil residues from the raw water,
with the use of carbon filtration being the most productive filter treatment to help remove dichlobenil
residues.  The combined use of aeration and filtration treatments should be effective  in removing the
majority of any dichlobenil residues from public drinking water supplies.

GENEEC was used to estimate both peak surface water concentration and a 56-day  surface water
concentration for use in a drinking water risk assessment.  Assuming an application rate of 8 Ib. ai/A
which is not incorporated into the soil, the peak concentration was estimated to be 380 ppb and the
56-day concentration to be 27 ppb. It should be noted that if the modeling used a lower application
rate or assumed incorporation, these estimates would decrease. See Table 25.

                     c.      Occupational and Residential

An occupational and/or residential exposure assessment is required for dichlobenil  based on
(1) adverse developmental and reproductive effects and (2) potential exposure to handlers (such as
mixers, loaders,  and applicators) during use. Due to the absence of a dermal absorption study,  100%
dermal absorption is assumed.
                                            28

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Handler (Mixer/Loader/Applicator) Exposure Scenarios

EPA has determined that there is an  exposure potential for mixers, loaders, applicators, or other
handlers during usual use-patterns associated with dichlobenil. Handler exposure scenarios are as
follows:

#      Homeowner application of the two percent G via belly grinder, self-contained shaker can, and
       other similar hand-held equipment.

#      Application of the four percent G via tractor-drawn or -mounted, rotary or drop-type
       spreaders, and backpack granular applicators.

#      Application of the 50 percent WP as a prepaving treatment via groundboom equipment.

#      Application  of the 50 percent WP (enclosed in water soluble packets) through foam-
       generating equipment to sewer systems.

The Agency does not have data generated by monitoring mixer/loader/applicator (M/L/A) exposure
to dichlobenil; therefore, surrogate data from the Pesticide Handlers Exposure Database (PHED) will
be used for this exposure assessment. The occupational exposure assessment will be performed for
the  short-term (1-7 days) scenario only.  Available information indicate that exposure based on
sewer  use can be considered an intermediate scenario.  Dichlobenil is routinely  applied by sewer
maintenance personnel throughout the root growing season.  However, there are no data to perform
an assessment. Once, the Agency  receives exposure data for the sewer use scenario, then an
intermediate term assessment will be performed.  For all  other scenarios, the annual usage data
available to the Agency does not seem to support either an intermediate-term or a  chronic exposure
scenario.  If, in the future, the annual usage data confirm that an intermediate-term (or chronic
scenario)  exists,  then another exposure assessment for an intermediate term  scenario will be
performed. See Table 3 for exposure  values and assumptions.
                                           29

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Table 3: Exposure Values for Handlers Using Dichlobenil
Exposure Scenario
Clothing Parameters
Dermal
Exposure
(mg/lb ai)
Inhalation
Exposure
(mg/lb ai)
Application
Rate
(Ib ai/cycle)
Daily Amt.
Treated
Daily Dermal
Exposure
(mg/kg/day)
Daily
Inhalation
Exposure
(mg/kg/day)
Combined Daily
Dermal and
Inhalation
Exposure
(mg/kg/day)
Mixer/Loader Exposure
Wettable Powder-Open Bag/Box (Sewer Treatment)
Wettable Powder- Water Soluble Packet (Sewer
Treatment)
Wettable Powders-Open Bag (Asphalt Treatment)
Granular Formulations - (Asphalt Treatment)
Granular Formulations - (Agricultural Treatments)
Granular Formulations - (Shelterbelt, Woody
Ornamental Treatments)
Granular Formulations - (Ornamental Linerstock
Treatments for Nutsedge Control)
Granular Formulations - (Industrial, Non-Crop,
Rights of Way Treatments)
Granular Formulations (Aerial Application)
Long-sleeved shirt, long pants,
gloves
Long-sleeved shirt, long pants,
gloves
Long-sleeved shirt, long pants,
gloves
Long-sleeved shirt, long pants,
gloves
Long-sleeved shirt, long pants,
gloves
Long-sleeved shirt, long pants,
gloves
Long-sleeved shirt, long pants,
gloves
Long-sleeved shirt, long pants,
gloves
Long-sleeved shirt, long pants,
gloves
0.1737
0.01
0.1737
0.0063
0.0063
0.0063
0.0063
0.0063
0.0063
0.0037
-
0.0037
0.0017
0.0017
0.0017
0.0017
0.0017
0.0017
10 Ib ai
10 Ib ai
10-121bai/A
10-121bai/A
4-6 Ib ai/A
4-8 Ib ai/A
10-20 Ib ai/A
12-20 Ib ai/A
1.4-2 Ib ai/A
-
-
5 acres
5 acres
30 acres
30 acres
5 acres
30 acres
100 acres
0.029
0.0016
0.145-0.174
0.0053 -
0.0063
0.0126-
0.0189
0.0126-
0.0252
0.0525-0.105
0.0378-0.063
0.0147-0.021
0.0006
-
0.003 - 0.004
0.0014-
0.0017
0.0034-
0.0051
0.0034-
0.0068
0.0014-
0.0028
0.01 -0.017
0.004-0.006
0.03
0.002
0.15-0.18
0.007-0.008
0.016-0.024
0.016-0.032
0.054-0.108
0.048-0.08
0.019-0.027
Applicator Exposure
Aerial Application (Granular Formulation) -
Dichondra
Groundboom Application, Open Cab (Asphalt)
Tractor-Drawn or-Mounted Granular Spreader
(Agricultural Treatments)
Tractor-Drawn or-Mounted Granular Spreader
(Shelterbelt, Woody Ornamental Treatments)
Tractor-Drawn or-Mounted Granular Spreader
(Ornamental Linerstock Treatments for Nutsedge
Control)
Long-sleeved shirt, long pants,
no gloves
Long-sleeved shirt, long pants,
no gloves
Long-sleeved shirt, long pants,
no gloves
Long-sleeved shirt, long pants,
no gloves
Long-sleeved shirt, long pants,
no gloves
0.009
0.017
0.013
0.013
0.013
-
-
0.0012
0.0012
0.0012
1.4-2 Ib ai/A
10- 12 Ib ai/A
4-6 Ib ai/A
4-8 Ib ai/A
10-20 Ib ai/A
100 acres
5 acres
30 acres
30 acres
5 acres
0.021-0.03
0.0142-0.017
0.026-0.039
0.026-0.052
0.011-0.022
-
-
0.0024 -
0.0036
0.0024 -
0.0048
0.001 - 0.002
0.021-0.03
0.014-0.017
0.028-0.043
0.028-0.057
0.012-0.024
                                                       30

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Exposure Scenario
Tractor-Drawn or-Mounted Granular Spreader
(Industrial, Non-Crop, Rights of Way Treatments)
Tractor-Drawn or-Mounted Granular Spreader
(Dichondra)
Sewer Treatment Using Foam Generating Equipment
Clothing Parameters
Long-sleeved shirt, long pants,
no gloves
Long-sleeved shirt, long pants,
no gloves
Long-sleeved shirt, long pants,
gloves
Dermal
Exposure
(mg/lb ai)
0.013
0.013
no data
Inhalation
Exposure
(mg/lb ai)
0.0012
0.0012
no data
Application
Rate
(Ib ai/cycle)
12-20 Ib ai/A
1.4-2 Ib ai/A
10 Ib ai
Daily Amt.
Treated
30 acres
30 acres
10 Ib ai/day
Daily Dermal
Exposure
(mg/kg/day)
0.078-0.13
0.0091-0.013
-
Daily
Inhalation
Exposure
(mg/kg/day)
0.0072-0.012
0.0008 -
0.0012
-
Combined Daily
Dermal and
Inhalation
Exposure
(mg/kg/day)
0.085-0.142
0.01-0.014
-
Mixer/Loader/Applicator
Homeowner Shaker-Container (Using a Hand
Dispersal of Granular Bait Surrogate)
Homeowner
Belly Grinder, Granular Spreader
Commercial
Belly Grinder, Granular Spreader
Commercial Granular Backpack Applicator
(Landscape Treatment)
Homeowner Sewer Treatment - Toilet Bowl Method,
Open bag/jar (from the open-bag wettable powder
M/L surrogate)
Total deposition (assumes no
protection from clothing)
Total deposition (assumes no
protection from clothing)
Long-sleeved shirt, long pants,
no gloves
No Data
Total deposition (assumes no
protection from clothing)
77.5
211
12.9
-
15.8
0.468
0.0618
0.0618
-
0.037
0.0009 Ib ai/10
sqft
0.0009 Ib ai/10
sqft
0.0009 Ib ai/10
sqft
-
0.01 llbai for
a 4" sewer pipe
Entire
contents of
the container
(0.025 Ib ai)
1000 sqft
(0.09 Ib ai)
10000 sqft
(0.9 Ib ai)
-
0.011 Ibai
per day
0.032
0.32
0.194
-
0.0029
0.0002
0.0001
0.001
-
~
0.032
0.32
0.195
-
0.003
Since the toxicological endpoint is from a developmental study the default body weight for a woman (60 kg) was used.

The daily exposure is calculated using the following formula:
                                                 Daily exposure (mg ai/kg bw/day) = unit exp. (nig ai/lb ai handled") x Ib ai/A x daily acres treated
                                                                                   body weight (60 kg)
                                                                                           31

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Post-Application Exposures

There are no data available to address post-application exposure for persons reentering areas treated
with dichlobenil.

Occupational Post-Application Exposures
The potential for dermal exposure following applications of dichlobenil appears to be limited.  Many
agricultural and horticultural applications are made to the soil early in the season and may be followed
by shallow incorporation or irrigation.  Therefore, workers would not ordinarily be in direct contact
with dichlobenil, unless their task involved activities in which the surface of the soil was disturbed.
For agricultural and horticultural situations, applications are usually made to established plants or
transplants established for at least four weeks in orchards or groves thus, limiting the potential for
worker activities requiring substantial contact with treated soil.  The granular formulation is not likely
to leave a significant deposit on foliage surfaces and use-directions indicate that deposit on foliar
surfaces is to be avoided.  In  addition, applications are also made when temperatures are below 70°
F, before weed seeds are germinating, and when harvesting and other usual hand-labor tasks are less
likely.  For raspberries and blackberries applications are prohibited during shoot emergence,  a time
when some postapplication tasks may take place.

However, the  Agency has concerns  about potential post-application  dermal  exposures  in  the
following situations: (1) uses  in dichondra-producing establishments which could involve substantial
contact with the soil subsurface, and (2) uses in nursery settings just prior to placement of ornamental
stock in liners.  In nursery  settings, workers are likely to place ornamental  stock in liners  on the
treated area soon after application is complete.

There is concern about post-application inhalation exposures for various horticultural and nursery
uses based on dichlobenil's moderate vapor pressure and the uncertainties of whether the various use-
scenarios should be considered to be short-term or intermediate-term. These concerns are for the
horticultural uses. For enclosed or confined horticultural uses, if dichlobenil is not soil-incorporated
the possibility for vaporization and resulting build-up of vapors exists.

Residential Post-Application Exposures
Homeowners may be engaged in hand-weeding or hand-mulching in treated areas which could involve
substantial contact with the  soil subsurface.
                                             32

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              3.     Risk Assessment

                    a.     Acute Dietary

                           (1)    Dichlobenil

The NOEL of 45 mg/kg/day from rabbit developmental study is used to assess acute dietary risk of
dichlobenil.

                                  (a)     Food

Residues of dichlobenil are not found on food.  Therefore, a risk assessment is not needed.

                                  (b)     Water

Since the NOEL for dichlobenil is taken from a developmental toxicity study the subpopulation of
interest for this risk assessment will  be  pregnant females (age 13+).   As discussed earlier, a
concentration of 380 ppb dichlobenil was used  as estimated by GENEEC.

Exposure for this subpopulation is calculated using the following formula:

Exposure (mg/kg/day)= (ppb in water consumed) (10~6) (upper 95 percentile drinking water intake)

The  10"6 conversion factor is necessary to achieve the final units of mg/kg/day and is derived as
follows:

                           (L) (ml H2O;> (me)
                    (103ml)(gH20)(103,ig)

The  upper percentile drinking water  intake estimates were derived from USDA's  1977-1978
nationwide Food Consumption Survey.

A MOE (Margin of Exposure) approach is used for estimating acute dietary risk. The MOE is a
measure of how closely the estimated high end exposure comes to the NOEL.  The MOE is calculated
by:
                    MOE = NOEL/exposure

                    MOE = 45/0.015= 3000 (rounded to 2 significant figures.)

The estimated MOE greatly exceeds 100, which is the level of concern when the NOEL is taken from
an animal study.  Thus, this screening assessment raises no concerns for acute dietary risk from
consumption of surface water-derived drinking water containing residues of dichlobenil.
                                           33

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If, the dichlobenil were to be incorporated, then GENEEC modeling indicated that the surface water
concentration would decrease to 190 ppb.  Thus, the MOE would be even larger.

                           (2)    BAM

There was no lexicological endpoint of concern from acute exposure to BAM. Therefore, an acute
dietary risk assessment is not needed.

Even though data are not currently available to determine levels of dichlobenil in ground water,
concentrations could be 30 times higher than the 380 ppb level derived using GENEEC for surface
water and still have an adequate MOE 100. The Agency does not believe that levels in ground water
will be of that magnitude.

                    b.     Chronic Dietary

                           (1)    Dichlobenil

The RfD for dichlobenil is based on a NOEL of 1.25 mg/kg/day from a 2-year dog feeding study with
a 100-fold safety factor applied.

                                  (a)    Food

Residues of dichlobenil are  not found on food.  Therefore, a risk assessment is not needed.

                                  (b)    Water

Using the 56-day surface concentration of 27 ppb estimated by GENEEC, exposure for the general
population is calculated using the formula:

Exposure (mg/kg/day)= (ppb in water consumed) (10~6) (upper 95 percentile drinking water intake)

                    Exposure= (27) (10'6) (50) = 0.001350 mg/kg/day

                    %RfD = 0.001350/0.013 = 10% (rounded to 1 significant figure)

Exposure for the subpopulation, non-nursing infants, assuming a 10 kg child, is calculated using the
formula:

                    Exposure (mg/kg/day) = (27) (10'6) (126.5) = 0.003415 mg/kg/day

                    %RfD = 0.003415/0.013 = 26% (rounded to 2 significant figures)

Generally, the Agency has no concerns when less than 100% of the RfD has been used.
                                           34

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As  stated  previously, GENEEC  can substantially  over-estimate  the  actual  drinking  water
concentration, which could mean that these risk estimates may also be over-estimated.

Even though there are no data for ground water with which to estimate exposure from drinking water
from that source, and given that only 26% of the RfD is utilized from high-end estimates for surface
water, the Agency has no risk concerns from exposure to drinking water from contaminated ground
water.  Data are being required through this RED to confirm this determination.

                           (2)    BAM

The RfD is based on a NOEL of 1.25 mg/kg/day from a 2 year dog feeding study with a 300-fold
safety factor applied.

                                  (a)     Food

As previously stated, the residue detected in the food supply is BAM.  Chronic dietary (food source)
risk for BAM was  estimated using the BAM RfD  of 0.015 mg/kg/day (MRID 42940203) for the
general U.S. population and 22 population sub-groups.  Tolerance level residues and 100 % crop
treated (CT) were assumed. Two ORES (Dietary Risk Evaluation System) runs using tolerance level
residues were performed. The first ORES run was performed using all the established tolerances per
40 CFR 180.231.  Even commodities for which revocation was proposed were included since as long
as the tolerance exists  commodities containing BAM residues could be imported.

Using All Established  Tolerances

Subgroup                           Exposuredng/kg/day'i                   %Reference Dose
U.S. population                          0.000612                                      4%
Nursing Infants (<  1 yr old)               0.001729                                     12%
Non-Nursing Infants (< 1 yr old)          0.002739                                     18%
Children (1-6 yrs old)                     0.001710                                     11%

All other sub-groups are less than 6% of the RfD.
For the second ORES run, it was necessary to estimate residues of BAM in meat (ruminant tissues)
and milk. As previously stated TRR data were used. The estimated residues are 0.0012 ppm in fat,
0.060 ppm in kidney, 0.47 ppm in liver, 0.012 ppm in muscle, and 0.0025 ppm in milk.

The second ORES run was performed using these estimated residues, the reassessed tolerances in
Section IV, Table 33 as well as tolerances proposed for revocation. It should be noted that it was
necessary to increase the tolerances for apples and pears, which are high consumption commodities
for infants and children. As explained in Table 33, this is due to the change of the tolerance expression
to include the BAM metabolite. It was also necessary to use the established tolerances for grapes,  and
                                           35

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the stone fruits group (peaches, plums, cherries, apricots, and nectarines) since additional data are
necessary to assess the adequacy of the established tolerances.
Using Reassessed Tolerances and Estimated Residues for Meat and Milk

Subgroup                          Exposurefmg/kg/day')                    %Reference Dose
U.S. population                          0.000701                                     5%
Nursing Infants (< 1 yr old)               0.001790                                    11%
Non-Nursing Infants (< 1 yr old)           0.002959                                    20%
Children (1-6 yrs old)                     0.001914                                    13%

All other sub-groups are less than 7% of the RfD.

These % RfDs can be considered to be over-estimates since DRES runs were performed using
tolerance level residues. It is likely that actual residues in the food supply are much lower. It is also
unlikely that 100% of a commodity has been treated with dichlobenil. Thus, there are no chronic
dietary concerns for consumption of the dichlobenil metabolite BAM.

                                  (b)    Water

 Adequate data to conduct a chronic drinking water assessment for BAM are not available to the
Agency.

                     c.     Short-Term Nondietary

Risk values from short-term exposure from occupational and homeowner uses of dichlobenil are
presented in Table 4.

As previously stated,  the  toxicological endpoint of concern for a short-term occupational and
residential  exposure is from a developmental toxicity study (MRID 41257302).  The NOEL  is 45
mg/kg/day.  The Margin of Exposure (MOE) is a measure of how closely the estimated exposure
comes to the NOEL. An MOE of 100 is considered to be acceptable when based on animal studies.
 The MOE  for short-term occupational and residential exposure for dichlobenil is:
                    Short-Term Exposure MOE =      45 mg/kg/day
                                               daily exposure (mg/kg/day)
                                           36

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Table 4:  Summary of Risk for Handlers Using Dichlobenil
Exposure Scenario
Combined Daily Dermal
and Inhalation Exposure
(mg/kg/day)
Short-Term
Margin of Exposure
Mixer/Loader Exposure
Wettable Powder-Open Bag/Box (Sewer Treatment)
Wettable Powder-Water Soluble Packet (Sewer Treatment)
Wettable Powders-Open Bag (Asphalt Treatment)
Granular Formulations - (Asphalt Treatment)
Granular Formulations - (Agricultural Treatments)
Granular Formulations - (Shelterbelt, Woody Ornamental Treatments)
Granular Formulations - (Ornamental Linerstock Treatments for Nutsedge
Control)
Granular Formulations - (Industrial, Non-Crop, Rights of Way Treatments)
Granular Formulations (Aerial Application)
0.03
0.002
0.15-0.18
0.007 - 0.008
0.016-0.024
0.016-0.032
0.054-0.108
0.048-0.08
0.019-0.027
1500
>20,000
250 - 300
5625 - 6429
1875-2813
1406-2813
417-833
563 - 938
1667-2368
Applicator Exposure
Aerial Application (Granular Formulation) - Dichondra
Groundboom Application, Open Cab (Asphalt)
Tractor-Drawn or-Mounted Granular Spreader (Agricultural Treatments)
Tractor-Drawn or-Mounted Granular Spreader (Shelterbelt, Woody
Ornamental Treatments)
Tractor-Drawn or-Mounted Granular Spreader (Ornamental Linerstock
Treatments for Nutsedge Control)
Tractor-Drawn or-Mounted Granular Spreader (Industrial, Non-Crop,
Rights of Way Treatments)
Tractor-Drawn or-Mounted Granular Spreader (Dichondra)
Sewer Treatment Using Foam Generating Equipment"
0.021 -0.03
0.014-0.017
0.028 - 0.043
0.028-0.057
0.012-0.024
0.085-0.142
0.01 -0.014
No Data
1500-2143
2647 - 3214
1047 - 1607
789 - 1607
1875-3750
317-529
3214-4500
..
Mixer/Loader/Applicator
Homeowner Shaker-Container (Using a Hand Dispersal of Granular Bait
Surrogate)
Homeowner- Belly Grinder, Granular Spreader
Commercial- Belly Grinder, Granular Spreader
Commercial Granular Backpack Applicator (Landscape Treatment)
Homeowner Sewer Treatment - Toilet Bowl Method, Open bag/jar (from
the open-bag wettable powder M/L surrogate)
0.032
0.32
0.195
..
0.003
1406
141
231
..
> 15000
              This is the only scenario for which the Agency can verify the need for an intermediate-term occupational scenario.
                                                     37

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Risk Estimates From Handler Exposures

All short-term MOEs are greater than 100 for all handler exposure scenarios for which there are data.
As previously  explained, the estimates taken from PHED were based on studies of mixers and
loaders wearing long-sleeved shirt, long pants, shoes, socks, and  chemical-resistant gloves; and
applicators wearing long-sleeved shirt, long pants, shoes, socks, and no gloves. Thus, there are no
occupational concerns for the short-term exposure scenarios for M/L/As attired as described in Table
3, or concerns for any of the residential scenarios.

There  are two data gaps: exposure data from the  use  of a backpack granular applicator and
applications to sewer pipes. It can be stated that the use of backpack applicators for liquids usually
results in high exposures.  However, it is likely that exposure from a granular backpack applicator
would be less since leaks are common with liquid backpack sprayers and the user is in close proximity
to the spray.   On the other hand,  granular backpack applicators  can cover greater areas,  since
applications can be made with swath widths of 20 feet. Granular backpack applicators are likely to
be used by occupational users; therefore, it is likely that larger areas can be treated with more days
of exposure than could be expected for liquid backpack applications, which are likely to be used by
homeowners.  These data shall be required.

The  other scenario for which there are no data is the application of  dichlobenil to sewer pipes.
Available information indicates that exposure based on sewer use can be considered to be an
intermediate exposure. These data shall be required.

Risk From Post-Application Exposures

As previously stated there are no data available to address postapplication exposure  (occupational
or residential) for persons reentering areas treated with dichlobenil.  Therefore, the risk could not be
quantitated. However, all short term MOEs for application are greater than  100.  It is assumed that
post-application exposure is less than exposure during application due to dissipation and degradation.
Thus, generally speaking any post-application MOEs (both occupational and residential) should be
even larger than application MOEs. When postapplication data are not available, interim REIs are
usually based on acute toxicity categories,  as  well  as an  evaluation  of the entire toxicological
database.  The acute toxicity  categories for dichlobenil are III/IV.

There  are a number of other  reasons exposure to home owners should be minimal.  Dichlobenil is
used to treat areas where all vegetation is to be killed (such as around  established trees and shrubs
or around buildings, fences, and other structures) rather than lawns or other areas where children's
play  or similar activities would be expected.  The 2G formulation label specifies that dichlobenil
should be applied "in early spring before weeds emerge" or "between late fall (after a killing frost)
and mid-winter". The cool  temperatures would minimize vaporization.  In early spring and late fall,
children playing outside are bundled up with sweaters and coats, and  are wearing shoes and long
                                            38

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pants. Thus, exposure is minimized by the clothing as well as by considering that a child spends less
time outdoors in the early spring versus the summer. Therefore, this cannot be considered a summer
scenario of children playing outdoors for long periods of time wearing shorts, short-sleeve tops, and
sandals or barefoot. As an additional mitigation measure the label recommends that after application
of dichlobenil the soil be moistened and applicators avoid disturbing the soil.  Both of these measures
would lock the dichlobenil beneath the soil surface, thereby minimizing exposure to granules.

The Agency notes dichlobenil is moderately volatile (vapor pressure of 5.5 x 10"4 mm Hg). Thus,
there are concerns for horticultural/ nursery workers and homeowners during treatments in confined
areas due to dichlobenil vapors.

Additionally, there may be concerns for horticultural workers during activities that disturb the soil.
The MOEs previously calculated were for application of dichlobenil. BAM is a soil metabolite.  It
is assumed that nursery workers could  be exposed to BAM during their routine activities.  The
Agency toxicological database for BAM is not as complete as that of dichlobenil.

Confirmatory post-application exposure data for both dichlobenil  and BAM for applications to
ornamentals are required.

              4.      FQPA Considerations

The Food  Quality Protection Act of 1996 (FQPA) amended the FFDCA by setting a new safety
standard for the establishment of tolerances. In determining whether a tolerance meets the new safety
standard, section 408(b)(2)(C) directs EPA to consider information concerning the susceptibility of
infants and children to pesticide residues in food, and available information concerning aggregate
exposure to infants and children of such residues, as well as the potential for cumulative effects from
pesticide residues and other substances that have a common mechanism of toxicity.

The FQPA amendments to section 408(b)(2)(C) also provide for an additional safely factor of up to
10-fold in situations  where available data indicate increased sensitivity of infants and children.

Section 408(b)(2)(D) establishes factors that the Agency must consider in determining whether the
safety standard is met in deciding to issue  or  reassess tolerances.   These factors include the
consideration of available information on the aggregate exposures to the pesticide from dietary
sources including drinking water as well as non-occupational exposures such as those derived from
pesticides used in and around the home. The Agency must also consider the potential cumulative
effects of the pesticide for which a tolerance is being sought as well  as other substances that have a
common mechanism of toxicity for the general population and major subgroups of the population.

Because dichlobenil has food uses, specific consideration of the risks  to infants and children, as well
as aggregate exposures and potential cumulative effects is warranted.
                                            39

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                     a.     Assessment of Additional Sensitivity to Infants and Children

For dichlobenil, an acceptable two-generation reproduction study in rats and acceptable prenatal
developmental toxicity studies in rats and rabbits, have been submitted to the Agency, meeting the
basic data requirements, as defined for a food-use chemical by 40 CFR Part 158.

Prenatal sensitivity:
In both the prenatal developmental toxicity studies in rats and rabbits, the NOELs for developmental
effects were greater than or equal to the NOELs for maternal toxicity.  The prenatal developmental
toxicity study in New Zealand White rabbits demonstrated decreased body weight gain and food
consumption in the maternal animals at a gavage dose of 135 mg/kg/day; at the same dose level, there
was an increased incidence of postimplantation loss and the occurrence of major external, visceral,
and skeletal anomalies in fetuses.  The maternal and developmental NOELs and LOELs in this study
were equivalent at 45 and 135 mg/kg/day, respectively. In Wistar rats, decreased maternal body
weight gain  and food consumption  were  observed at the LOEL of 60 mg/kg/day (NOEL = 20
mg/kg/day),  while an increase in supernumerary ribs was observed in fetuses at the LOEL of 180
mg/kg/day (NOEL = 60 mg/kg/day).  In the two-generation reproduction study in Sprague-Dawley
rats, a significant decrease in the birth weight of Fl pups was observed at a dietary dose level of 350
ppm (17.5 mg/kg/day). This decreased pup weight occurred without maternal toxicity. Nevertheless,
the effect was not repeated in the second generation (at the same dietary level, the F2 pups weighed
more than control pups), and a clear dose response relationship was not present in the pup weight
decreases of the first generation. Based upon these data, the Agency concludes that there is no
evidence of increased sensitivity  of rats or rabbits  to prenatal exposure to dichlobenil.  This
conclusion is also supported by the findings of the prenatal developmental toxicity study in New
Zealand White rabbits with BAM, the dichlobenil plant metabolite which is the primary residue of
concern for dietary exposure.   In that study, the maternal NOEL (10 mg/kg/day), based upon
moribundity  at 30 mg/kg/day, was lower than the developmental NOEL of 30 mg/kg/day, based upon
nonsignificantly decreased fetal body weight at 90 mg/kg/day.

Postnatal sensitivity:
In the two-generation reproduction study  in  Sprague-Dawley rats,  the  offspring NOEL was
established at 60 ppm (3 mg/kg/day), based upon pup weight decreases observed at the LOEL of 350
ppm (17 mg/kg/day). The parental toxicity NOEL was 350 ppm (17 mg/kg/day) and the LOEL was
2000 ppm (100 mg/kg/day), based upon decreased body weight gain and food consumption. A lower
NOEL in offspring than adults is suggestive of increased sensitivity to the offspring following
exposure to dichlobenil. In the evaluation of this possibility, the following additional information was
considered:

•      As previously addressed, the birth weight decrease was discounted as evidence of prenatal
       sensitivity to dichlobenil,  due to lack of consistency between generations and the absence of
       a clear dose response.
                                           40

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•      A significant decrease in pup weight on postnatal day 4 also only occurs in first generation
       pups which had been of low birth weight.

•      Significantly decreased pup weight on postnatal days 14 and 21 occurred in both generations
       (Fl and F2 pups) in a dose-response relationship. It was noted by the Agency that the pups
       were consuming treated feed, as well as receiving the dichlobenil in the maternal milk during
       this time period. Therefore, it is noted that the actual dose to  the pups was  likely to be
       exceptionally high  on a mg/kg basis, although exact estimates of the difference in test
       substance intake between adults and offspring cannot be made.

•      For the first generation (Fl) pups, significant differences in mean body weight that are
       observed  at weaning  (postnatal day 21) in the 350 ppm (17.5 mg/kg/day) dose group are
       absent in the first week of the premating period (approximately 3  to 5 weeks  of age).  At
       2000 ppm (100 mg/kg/day) significantly decreased Fl weight gain is still demonstrated at this
       point in time.

•      A cursory review of the limited and inadequate data from the 3-generation reproduction study
       in rats with BAM, the primary metabolite of concern, by an ad hoc committee, had previously
       indicated that an inconsistent pattern of decreased pup body weights on postnatal day 21 was
       the only offspring toxicity  noted  in this study at the HDT of 180 ppm (approximately 9
       mg/kg/day), and that no issues of additional sensitivity following postnatal exposure to BAM
       were identified.

Based on the above, only minimal confidence could be placed in the pup body weight data that
appeared to suggest an increase in sensitivity to the offspring of rats following postnatal exposure to
dichlobenil.

Other Factors Considered :
The RfD value for dichlobenil was  calculated to be 0.013 mg/kg/day, based upon a NOEL of 1.25
mg/kg/day from  the chronic study in dogs.   It was noted that the offspring NOEL for the two-
generation reproduction study in rats was 3  mg/kg/day, based upon body weight decrements in pups.
If estimating an approximate doubling or tripling of feed intake between young and old rats on the
reproduction study, the NOEL on the  reproduction study  would be nearly 6 to 9 times that of the
NOEL from the chronic canine study.

Based upon the use patterns for dichlobenil, it is considered unlikely that infants and children will be
exposed to this chemical.  Dietary exposure to the plant metabolite, BAM, is more likely to occur.
The assessment of the available data for BAM identified a data gap for the prenatal developmental
toxicity study in rodents, and due to the lack of these data, an additional 3-fold uncertainty factor was
included in the risk assessment for BAM. For BAM, the developmental NOEL (30 mg/kg/day) was
6.7-fold greater than the NOEL used to determine the RfD (4.5 mg/kg/day, from the chronic toxicity
study in dogs).
                                            41

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Based upon the information discussed above, the Agency is confident that adequate protection of
infants and children would be ensured by the use of an uncertainty factor of 100 (10X for interspecies
variability and 10X for intraspecies variability) in the risk assessment for dichlobenil.

                     b.     Aggregate (Multi-Pathway) Exposure and Resultant Risk

An aggregate risk assessment resulting from combining exposures from residential uses of dichlobenil
with exposures from drinking water consumption could be performed. When comparing exposures
from  the homeowner application scenarios and adult  consumption of dichlobenil contaminated
drinking water, the exposure value for consumption of drinking water is orders of magnitude lower
than that of a homeowner applicator.  Therefore, the risk is essentially that of residential exposure
alone  since the contribution from drinking water is insignificant in comparison.  Note that the Agency
has no information to indicate that this type of exposure is likely to occur.

Only  one scenario exists where aggregating exposures  and  calculating risk is appropriate.  This is
presented below.

BAM

Exposure to BAM can occur from exposure to food and from drinking contaminated water.  As no
acute  toxicity endpoint was identified, only a chronic risk assessment is appropriate.

Chronic dietary risks  for BAM from food  sources are summarized below.  These risks can be
considered to be overestimated since tolerance level residues and 100% crop treated are assumed.
Actual risks will be much lower.

Subgroup                                       %  Reference Dose
U.S. population                                 5%
Nursing infants (<1 yr old)                        11%
Non-nursing infants (<1 yr old)                    20%
Children (1-6 yrs old)                       13%
Water:

At this time, the Agency does not have adequate data to perform a quantitative chronic drinking
water risk assessment for BAM.  The most highly exposed subpopulation from food containing
residues of BAM is non nursing infants which utilizes 20% of the RfD.  Thus, the drinking water risk
from BAM could be as high as 80 percent of the RfD and still be protective of the public health.  Data
are being required through this RED to confirm the Agency's conclusion that the aggregate risk does
not exceed 100 percent of the BAM RfD.
                                           42

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                     c.       Cumulative Effects

Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a
tolerance, the Agency consider "available information" concerning the cumulative effects of a
particular pesticide's residues and "other substances that have a common mechanism of toxicity."  The
Agency believes that "available information" in this context might include not only toxicity, chemistry,
and  exposure data,  but  also scientific policies and methodologies for understanding common
mechanisms of toxicity and conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be helpful in eventually determining
whether a pesticide shares a common mechanism of toxicity with any other substances, EPA does not
at this time have the methodologies to resolve the complex  scientific issues concerning common
mechanisms of toxicity in a meaningful way. EPA has begun a pilot process to study this issue further
through the examination of particular classes of pesticides.  The Agency hopes that the results of this
pilot process will increase the Agency's scientific understanding of this question such that EPA will
be able to develop and apply scientific principles for better determining which chemicals have a
common mechanism of toxicity and evaluating the cumulative effects of such chemicals. The Agency
anticipates, however, that even as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on chemical specific data, much
of which may not be presently available.

Although at present the Agency does not know how to apply the information in its files concerning
common mechanism issues to most  risk assessments,  there are pesticides for  which common
mechanism issues can be resolved.  For example, pesticides  that are lexicologically dissimilar  to
existing chemical substances (in which case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and pesticides that produce a common
toxic metabolite (in which case common mechanism of activity will be assumed).

Bromoxynil is the only compound found to have structural similarities to dichlobenil. Note that the
BAM metabolite is not a benzonitrile, but a benzamide.

Structurally, both dichlobenil and bromoxynil are halogenated benzonitrile compounds. However,
dichlobenil is di-chlorinated, while bromoxynil is di-brominated (in different positions relative to the
nitrile group); and bromoxynil is hydroxylated para to the nitrile moiety.

While the compounds have some similar toxic effects, there are many differences in their toxicities.
Similarities include some liver effects (both cause liver tumors and other liver effects), but dichlobenil
causes numerous  other toxic effects not seen with bromoxynil including effects on the prostate,
pancreas, thyroid and adrenal glands.

Therefore, while some similarities exist between the two chemicals, there is insufficient information
available at this time to conclude that they do or do not have a common mode of action with regard
to human toxicity.  The likelihood of exposure to both bromoxynil  and dichlobenil (parent) is small.
Bromoxynil has not been detected in water and has no residential uses. Dichlobenil is not detected
                                            43

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in the food supply. A cumulative exposure assessment resulting from use of these chemicals has not
been performed.

In the case of dichlobenil, EPA does not have at this time, available data to determine whether
dichlobenil has a common mechanism of toxicity with other substances or how to  include this
pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, dichlobenil does not appear to
produce a toxic metabolite produced by other substances.  For the purposes of this tolerance action,
therefore, EPA has not assumed that dichlobenil has a common mechanism of toxicity with other
substances.

       C.     Environmental Assessment

The environmental assessment consists of four sections: the first section reports ecological toxicity
data from laboratory studies; the second section describes the environmental fate and transport data
from  field and laboratory  studies,  analyzes the impact  to water resources,  and details the
environmental fate assessment; the third section estimates ecological exposure and  assesses the
effects to non-target terrestrial and aquatic organisms;  the fourth section,  the environmental risk
characterization section, integrates the exposure and effects assessment to determine the extent and
potential for risk to the environment.

The ecological risk characterization was limited to anticipated exposures from the use of the granular
formulations. Non-granular formulations, such as the wettable powder and foam formulations, are
only used to treat pre-pavement areas and sewage systems, and are not expected to result in exposure
to non-target organisms.

              1.      Ecological Toxicity Data

The Agency  has adequate data to assess the acute hazards of dichlobenil  to nontarget terrestrial
animals but does not have data to assess the  chronic hazards of dichlobenil to nontarget birds.
Adequate data to assess the acute and chronic hazards of dichlobenil to nontarget aquatic animals are
available. Adequate data are available to assess the hazards of dichlobenil to non-target plants from
runoff,  however, the Agency does not have adequate data to assess the hazards to non-target
terrestrial plants from dichlobenil volatilization.

                     a.     Toxicity to Terrestrial Animals

                            (1)     Birds, Acute and Subacute

The basic avian studies required for all pesticides (using the technical grade material) are one avian
single-dose oral  (LD50) study on one species (preferably mallard or bobwhite quail) and two  subacute
dietary studies (LC50) on one species of waterfowl (preferably the mallard duck) and one species  of
upland game birds (preferably bobwhite quail).
                                            44

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  Table 5
   Avian Acute Oral Toxicity Findings
Species
Northern Bobwhite
Mallard Duck
Mallard Duck
Ring-necked Pheasant
% A.I.
98.8
98.7
99.4
98.9
LD50
ing/kg
683
>2000
>50
1189
MRID
43469801
00160000
40600601
00160000
Author/Year
Johnson, 1994
Hudson, 1984
Roberts, 1988
Hudson, 1984
Toxicity
Category
slightly toxic
practically
non-toxic
n/a
slightly toxic
Fulfills Guideline
Requirement
Yes
Yes
No, Supplemental
Yes
Table 6
Avian Subacute Dietary Toxicity Findings
Species
Northern Bobwhite
Japanese Quail
Ring-necked Pheasant
Mallard
% A.I.
99.4
96.4
96.4
99.4
LC50
ppm
5200
>5000'
1500
>5200
MRID
40600603
00022923
00022923
40600602
Author/Year
Roberts, 1988
Hill, 1975
Hill, 1975
Roberts, 1988
Toxicity
Category
practically
non-toxic
practically
non-toxic
slightly toxic
practically
non-toxic
Fulfills Guideline
Requirement
Yes
No, Supplemental
Yes
Yes
              1 At 5000 ppm dose level, 19% of the birds died.

These results indicate dichlobenil is slightly to practically non-toxic to avian species on an acute oral
and subacute dietary basis.

                            (2)     Birds, Chronic

Avian reproduction studies are required when birds may be exposed repeatedly or continuously
through persistence, bioaccumulation, or multiple applications; or if mammalian reproduction tests
indicate a reproductive hazard.  In the 2-generation rat reproduction study (MRIDs 41257303,
42239101), the reproductive NOEL was 3 mg/kg/day (60 ppm) for dichlobenil and dichlobenil may
be persistent. Two avian reproduction studies are required on one species of waterfowl (preferably
the mallard duck) and one species of upland game bird (preferably bobwhite quail). Currently no
avian reproduction data are available.  Therefore, this guideline has not been satisfied. A chronic risk
assessment for birds can not be performed.

                            (3)     Mammals

Wild mammal testing is required on a case-by-case basis, depending on the results of the lower tier
studies such as acute and subacute testing, intended use pattern, and pertinent environmental fate
characteristics. In most cases, however, an acute oral LD50 from the OPP's Health Effects Division
(HED) is used to determine toxicity to mammals.  This LD50 is reported below.
                                            45

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  Table 7
   Mammalian Acute Toxicity Findings for Dichlobenil
Species
Rabbit (mammal surrogate)
Rat (small mammal surrogate)
LD50 ing ai/kg
> 2 g/kg
4250
Toxicity Type
Dermal
Oral
MRID
43250401
00112500
The available mammalian data indicate that dichlobenil is slightly to practically non-toxic to small
mammals on an acute oral basis.
  Table 8       Mammalian Acute Toxicity Findings for Degradate
                2,6-dichlorobenzamide (BAM)
Species
Mice (small mammal surrogate)
Rat (small mammal surrogate)
LD5(> ing ai/kg
1538 (M)
1144(F)
1470 (M)
2330 (F)
Toxicity Type
Oral
Oral
MRID
42940201
00111402
The available mammalian data indicate that the dichlobenil degradate BAM is slightly toxic to small
mammals on an acute oral basis. Although mice appear to be the most sensitive mammal and are used
in the human health assessment, the rat LD50 was used in the mammalian toxicity assessment because
it is the standard species used in eco-toxicity assessments.
Table 9
Mammalian Sub-Acute Toxicity Findings for Dichlobenil
Species
Rabbit (mammal surrogate) tested on
2,6 dichlorobenzamide (BAM)
Rabbit (mammal surrogate)
Rat (small mammal surrogate)
Rat (small mammal surrogate) 2
NOEL / LOEL
10/30 mg/kg/day1
45 / 135 mg/kg/day1
20 / 60 mg/kg/day1
3/15 mg/kg/day
(60/350ppm)
Study Type
developmental toxicity - Endpoint affected is mortality
(6 day exposure)
developmental toxicity - occurrence of major external,
visceral, and skeletal defects. (12 day exposure)
developmental toxicity - decreased weight gain, food
consumption, and food efficiency from maternal. (10 day
exposure)
2-generation reproduction - reduced pup weight. No other
endpoints affected. Highest dose is 2000 ppm (100
mg/kg/day)
MRID
43003601
43265201
41257302
00147437
41257303
42239101
              1 Doses were done by gavage.
              2 Study report indicates dichlobenil made the feed unpalatable and affected the endpoints.


According to these studies, the lowest NOEL for subacute and reproductive effects to mammals is
60 ppm.  At 350 ppm, dichlobenil reduced pup weight.
                                            46

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                            (4)    Insects

A honey bee acute contact LD50  study is required if the use will result in honey bee exposure. The
use of granular pesticides results  in minimal exposure to honey bees.
  Table 10
Nontarget Insect Acute Contact Toxicity Findings
Species
Honey Bee
%AI
technical
LD50 ng a.i./bee
>120
MRID
0001884
2
Author/Year
Atkins, 1969
Toxicity Category
practically
non-toxic
Fulfills Guideline
Requirement
Yes
There is sufficient information to characterize dichlobenil as practically non-toxic to bees.

                     b.     Toxicity to Aquatic Animals

                            (1)     Freshwater Fish

The basic fish studies required for all pesticides (using  the  technical grade material) are two
freshwater fish toxicity studies.  One study should use a cold water species (preferably the rainbow
trout), and the other should use a warm water species (preferably the bluegill sunfish).
                                            47

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  Table 11
Freshwater Fish Acute Toxicity Findings for Dichlobenil
Species
Rainbow Trout
Rainbow Trout
Bluegill Sunfish
Bluegill Sunfish
Fathead Minnow
Fathead Minnow
Goldfish
Goldfish
Green Sunfish
Green Sunfish
Rainbow Trout
% A.I.
98.9
98.9
98.9
98.9
98.9
98.9
98.9
98.9
98.9
98.9
99.5
LC50 ppin a.i.
6.26
4.931
6.721
8.31
6.00
7.121
7.83
7.681
5.7
12.61
7.6
MRID
40098001
40098001
40098001
40098001
40098001
40098001
40098001
40098001
40098001
40098001
43846901
Author/Year
Mayer, 1986
Mayer, 1986
Mayer, 1986
Mayer, 1986
Mayer, 1986
Mayer, 1986
Mayer, 1986
Mayer, 1986
Mayer, 1986
Mayer, 1986
McCann, 1975
Toxicity
Category
moderately toxic
moderately toxic
moderately toxic
moderately toxic
moderately toxic
moderately toxic
moderately toxic
moderately toxic
moderately toxic
moderately toxic
moderately toxic
Fulfills Guideline
Requirement
Yes
No, Supplemental
No, Supplemental
Yes
No, Supplemental
No, Supplemental
No, Supplemental
No, Supplemental
No, Supplemental
No, Supplemental
Yes
       1 The test was conducted in hard water with 272 mg/L of CaCO3. Guideline studies are conducted in water with hardness of 40-48 mg/L CaCO3
       for bluegill and trout.


The results of the 96-hour acute toxicity studies indicate that dichlobenil is moderately toxic to fish.
  Table 12
      Freshwater Fish Acute Toxicity Findings for
             2,6 dichlorobenzamide (BAM)
Species
Rainbow trout
Rainbow trout
Bluegill Sunfish
Poecilia reticulaia
% A.I.
97.0
100
100
97.0
LC50 ppm a.i.
235
140
120
275
MRID
00156312
40098001
40098001
00156312
Author/Year
Van
Leeuwen,1985
Mayer, 1986
Mayer, 19 86
Van
Leeuwen,1985
Toxicity
Category
practically
non-toxic
practically
non-toxic
practically
non-toxic
practically
non-toxic
Fulfills Guideline
Requirement
No, Supplemental
Yes
Yes
No, Supplemental
The results of the 96-hour acute toxicity studies indicate that BAM is practically non-toxic to fish.
                                              48

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Data from fish early life-stage tests are required if the product is applied directly to water or expected
to be transported to water from the intended use site, and if the pesticide's acute LC50  or EC50 is
greater than 1 mg/L or studies of other organisms indicate the reproductive physiology offish may
be affected or the half-life of the aerobic aquatic metabolism half-life is greater than 4 days.  This
study is not required at this time since dichlobenil is no longer directly applied to water, nor does it
meet the other criteria.  However, the registrant submitted data that were used in the risk assessment
(see table below).
Table 13 Fish Early Life-Stage Toxicity Findin
Species
Rainbow
trout
Rainbow
trout
% A.I.
97.01
99.4
NOEL
ppm
10.0
0.66
<0.33
LOEL
ppm
18.0
1.2
0.33
MATC
ppm
13.4
0.89
0.33
MRID
00156312
408251012
422242022
Author/Year
Van Leeuwen, 1985
McAllister, 1988
Dykstra, 1992
gs
1 ml point
Affected
60-day survival,
length, weight
mortality
length
Fulfills Guideline
Requirement
No, Supplemental
Yes
       1 The chemical tested is the metabolite BAM
       2 MRIDs 40825101 and 42224202 are from the same study

The results indicate that dichlobenil may chronically affect fish at levels as low as 0.33 ppm.

Field studies can be required when the pesticide is applied directly to water as in aquatic weed
control.  Dichlobenil was previously registered for aquatic weed control and the field study was
provided.  Although these  data are no longer required because dichlobenil is  no longer directly
applied to water, the Agency has included them in the risk assessment.
  Table 14
  Aquatic Field Studies Findings
Species
Green Sunfish
Largemouth Bass
Bluegill Sunfish
% A. I.
50.0
MRID
Author/Year
00113752
Cope, 1968
Findings
Mortality of bluegill fingerlings more likely due to subacute
affects at concentrations as low as 5 ppm ai (lowest
measured concentration).
Fulfills Guideline
Requirement?
No, supplemental
                             (2)
Freshwater Invertebrates
The basic freshwater invertebrate study required for all pesticides (using the technical grade material)
is freshwater aquatic invertebrate toxicity test, preferably using first instar Daphnia magna or early
instar amphipods, stoneflies, mayflies, or midges.
                                             49

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  Table 15	Freshwater Invertebrate Toxicity Findings
Species
Simocephalus serrulatus
(daphnid)
Pteronarcys californica
(stonefly)
Gammarus lacutris
(scud)
Asellus brevicaudus
(sowbug)
Daphnia pulex
(daphnid)
Gammarus fasciatus
(scud)
Asellus brevicaudus
(sowbug)
Daphnia magna
(daphnid)
Palacmonetes
kadiakensis
(glass shrimp)
Cypridopsis vidua (seed
shrimp)
Daphnia magna
(daphnid)
% A.I.
50.0
50.0
50.0
50.0
50.0
tech.
tech.
tech.
tech.
tech.
99.0
ECSO ppm
5.8
7.0
5.8
35.0
3.7
18.0
34.0
10.0
9.0
7.8
6.2
MRID
4009460
2
4009460
2
4009460
2
4009460
2
4009460
2
0500149
7
0500149
7
0500149
7
0500149
7
0500149
7
4077500
1
Author/Year
Johnson, 1980
Johnson, 1980
Johnson, 1980
Johnson, 1980
Johnson, 1980
Sanders, 1970
Sanders, 1970
Sanders, 1970
Sanders, 1970
Sanders, 1970
Burgess, 1987
Toxicity Category
moderately toxic
moderately toxic
moderately toxic
slightly toxic
moderately toxic
slightly toxic
slightly toxic
moderately toxic
moderately toxic
moderately toxic
moderately toxic
Fulfills Guideline
Requirement
No, Supplemental
No, Supplemental
No, Supplemental
No, Supplemental
No, Supplemental
No, Supplemental
No, Supplemental
No, Supplemental
No, Supplemental
No, Supplemental
Yes
There is sufficient information to characterize dichlobenil as slightly to moderately toxic to aquatic
invertebrates.

 Table 16   Freshwater Invertebrate Toxicity Findings 2,6 dichlorobenzamide (BAM)
Species
Daphnia magna (daphnid)
% A.I.
97.0
ECSO ppm
856
MRID
Author/Year
00156312
Van Leeuwen, 1985
Toxicity
Category
practically
non-toxic
Fulfills Guideline
Requirement
No, Supplemental
There is sufficient information to characterize BAM as practically non-toxic to aquatic invertebrates.
                                            50

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Data from aquatic invertebrate life cycle studies are required if the product is applied directly to water
or expected to be transported to water from the intended use site, and if the pesticide's acute LC50
or EC50 is greater than 1 mg/L or studies of other organisms indicate that reproduction of aquatic
invertebrates may be affected or the pesticide's aerobic aquatic metabolism half-life is more than 4
days.
  Table 17
Aquatic Invertebrate Life-Cycle Toxicity Findings
Species
Daphnia
magna
Daphnia
magna
%
A.I.
97.01
99.0
NOEL
ppm
>320
0.56
LOEL
ppm
N/A
1.0
MATC
(unit)
N/A
0.75
MRID
00156312
40775002,
42224201
Author/Year
Van Leeuwen, 1985
Forbis, 1988,
1992
1 ml point
Affected
reproduction and
21 -day survival
delayed
reproduction
Fulfills Guideline
Requirement
No, supplemental
Yes
                     1 The chemical tested is 2,6-dichlorobenzamide (BAM)

The results indicate that dichlobenil may chronically affect aquatic invertebrates at concentrations as
low as 0.75 ppm.
                            (3)
               Estuarine and Marine Animals
Acute toxicity testing with estuarine and marine organisms is required because the terrestrial non-
food, cranberry and turf use of dichlobenil may result in exposure to the estuarine environment.

The requirements under this category include a 96-hour LC50 for an estuarine fish, a 96-hour LC50
for shrimp, and either a 48-hour embryo-larvae study or a 96-hour shell deposition study with oysters.
  Table 18
    Estuarine/Marine Acute Toxicity Findings
Species
Eastern Oyster embryo
larvae
Pink Shrimp
Mysid Shrimp
Sheepshead Minnow
Eastern Oyster shell
growth
Sheepshead Minnow
% A.I.
98.9
98.9
98.8
98.8
98.8
98.9
LCSO/ECSO
(ppm)
2.5
>1.0
2.35
12.7
1.63
14.0
MRID Author/Year
40228401
Mayer, 19 86
40228401
Mayer, 1986
43905405
Durham, 1995
43905403
Durham, 1995
43905404
Durham, 1995
40228401
Mayer, 1986
Toxicity
Category
moderately toxic
N/A
moderately toxic
moderately toxic
moderately toxic
slightly toxic
Fulfills Guideline
Requirement
Yes
No, supplemental
Yes
Yes
Yes
Yes
There is sufficient information to characterize dichlobenil as slightly to moderately toxic to estuarine
organisms.
                                             51

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                     c.      Toxicity to Plants

                            (1)     Terrestrial

Tier II toxicity data on the technical material for the most sensitive species are listed below:
 Table 19
       Terrestrial Plant Toxicity
Study Type
Seedling Emergence
Species
dicot - lettuce
monocot - oat
NOEC or EC05
(Ib ai/A)
0.011
0.084
EC25 (Ib ai/A)
0.023
0.120
MRID
41280801
Author, Year
Eussen, 1989
Fulfills Guideline
Requirements
Yes
The results indicate that non-target terrestrial plants may be affected from runoff if the runoff exceeds
0.023 Ib ai/A. The guideline requirements are fulfilled for seedling emergence. Seed germination
requirements  have been  waived  because the seedling  emergence study is a more  sensitive
measurement. The vegetative vigor portion of the study was reviewed and found to be invalid. At
this time, the Agency is not requiring a new vegetative vigor study.

                            (2)     Aquatic

Tier II aquatic plant studies are required for all herbicides. The following species should be tested:
Selenastrum capricornutum, Lemna gibba, Skeletonema costatum,  Anabaena flos-aquae, and a
freshwater diatom. Tier II toxicity data on the technical material  are listed below:
 Table 20
Nontarget Aquatic Plant Toxicity Findings
Species
Navicula pelliculosa (Freshwater diatom)
Lemna gibba (duckweed)
Selenastrum capricornutum (green algae)
Skeletonema costatum (marine diatom)
Anabaena flos-aquae (blue-green algae)
Isochrysis galbana (estuarine algae)
Phaeodactylum tricornutum (estuarine algae)
Dunaliella tertiolecta (estuarine algae)
Chlorella pyreoidosa (estuarine algae)
Chlorococcum sp. (estuarine algae)
% A.I.
99.0
99.0
99.0
99.0
99.0
98.9
98.9
98.9
97.01
98.9
NOEC
(ppm)
0.31
0.006
0.16
0.63
2.5
no data
no data
no data
no data
no data
EC5(> ppm ai
1.000
0.030
1.500
2.100
2.900
60.0
25.0
60.0
100.0
60.0
MRID
40758204
40758203
40758201
40758205
40758202
40228401
40228401
40228401
00156312
40228401
Author/year
Giddings, 1988
Giddings, 1988
Giddings, 1988
Giddings, 1988
Giddings, 1988
Mayer, 1986
Mayer, 1986
Mayer, 1986
Van Leeuwen, 1985
Mayer, 1986
Fulfills Guideline
Requirement
Yes
Yes
Yes
Yes
Yes
No, Supplemental
No, Supplemental
No, Supplemental
No, Supplemental
No, Supplemental
                     1 The chemical tested is the degradate BAM.

The results indicate that dichlobenil is toxic to an aquatic macrophyte (duckweed).
                                            52

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              2.     Environmental Fate

Acceptable and supplemental information from environmental  fate studies with respect to the
persistence and mobility of dichlobenil under laboratory and field conditions has been reviewed and
the environmental data base for dichlobenil is essentially complete.

                     a.      Environmental Fate and Transport

                            (1)     Degradation

Hydrolysis

Dichlobenil is stable to degradation by hydrolysis. The calculated half-life, extrapolated from a 30 day
study, is >150 days in sterilized buffers at pH 5, 7 and 9.   This guideline requirement is fulfilled.
(MRID  40548502).

Photodegradation in Water

Uniformly ring-labeled [14C] dichlobenil (radiochemical purity 99.3%) at 5.749 mg/L, degraded with
a calculated half-life of 15.1 days at pH 7.  A major degradate was 4-chloro-2(3H)benzoxazolone
(BZZ) present at 17% of total [14C] at 21 days. Additional degradates, found at low levels, identified
in the irradiated samples  at 21  days  were  2-hydroxybenzonitrile  (4%  of total  [14C]),  2,6-
dichlorobenzoic acid  (3%   of  total [14C]),  2-chlorobenzonitrile (2%  of total   [14C]),  2,6-
dichlorobenzamide (1% of total [14C]), and 4-hydroxy-2,6-dichlorobenzonitrile (1% of total [14C]).
Up to 5% of the applied were lost to volatility by day 21.  This guideline requirement is fulfilled.
(MRID  41709801).

Photodegradation on Soil

Dichlobenil is persistent in soil photodegradation studies. Dichlobenil did not photodegrade under
the conditions of the soil photolysis experiment (i.e. continuously irradiated with a xenon arc lamp
at 25 C for 30 days). However, dichlobenil dissipated with a half-life of 4.7 days in the dark control.
The study authors attributed this to the volatilization of the compound, lack of trapping efficiency,
and lack of water jacket surrounding the dark control. No degradates were identified in the irradiated
or dark control soil samples. This guideline requirement is fulfilled. (MRIDs 41119001; 43006801).
                                            53

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Aerobic Soil Metabolism

Dichlobenil is persistent to metabolism in soil under aerobic conditions. Dichlobenil degraded from
sandy loam soil with a  calculated  half-life of 13 weeks;  most of the dissipation was due  to
volatilization of dichlobenil. Of the 61.0% of total 14C trapped, 56.8% was dichlobenil and 2.3% was
CO2. When correcting for the volatilization, the calculated half-life of dichlobenil was 46.3 weeks.
One degradate identified, 2,6-dichlorobenzamide (BAM), was 13.1% (maximum concentration) at
50 weeks.  The guideline requirement (162-1) is fulfilled.  (MRIDs 41340601; 43006803).

Anaerobic Aquatic Metabolism

Dichlobenil is persistent to metabolism under anaerobic aquatic conditions. Dichlobenil exhibited a
half-life of 2.8 years in lake water:sediment slurries incubated under anaerobic conditions for 370
days.  The guideline requirement is fulfilled.  (MRTD 41306001).

Aerobic Aquatic Metabolism

Dichlobenil exhibited a  half-life of  2.4 days in sedimentlake water systems;  the major route  of
dissipation was due to volatilization; > 97% of the applied 1 ppm dichlobenil was found in the traps
as the base catalyzed hydrolysis product 2,6-dichlorobenzamide. No degradates were identified and
no correction in half-life was calculated. The guideline requirement is fulfilled. (MRTD 41149501).

                            (2)    Mobility

Adsorption/Desorption  Studies

Acceptable and supplemental studies indicated mobility is related to the soil  organic matter (OM)
content ranging from mobile with low  OM soils to relatively immobile with high  OM soils. Freundlich
Kads values of 0.295, Koc = 49, silt loam 0.6% OM; Kads = 2.098, Koc = 110,  silty loam 1.9% OM; Kads
= 3.197, Koc = 114, aquatic sediment 2.8% OM; Kads = 6.141, Koc = 205, loam 3.0% OM; Kads =
5.576, Koc = 116,  sand 4.8% OM. (MRIDs 40600604; 43006800).

In an additional  study, adsorption was also correlated with organic matter  content of the  soils.
Freundlich Kads values of 0.3 for the  sand soil (0.28% OM), 4.2 for the hydrosoil (2.24% OM), 7.4
for the silt loam (4.7% OM), 9.6 for  the clay soil (12.4% OM), and 10.5  for the sandy loam (6.9%
OM); respective Koc values were 195, 323, 272,  133, 262 . Adsorption was correlated with the
organic matter content of the soils (correlation coefficients were 0.992-0.999). (MRTD 43611101).

Supplemental studies indicated that dichlobenil at 0.5-10 ppm adsorbed to sandy clay loam, sandy
loam, and sand soils with Freundlich Kads values of 4.80, 4.23, and 2.71,  respectively. Adsorption
appeared to be correlated with soil organic matter content. (MRTD 00049725).
                                            54

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Soil Column Leaching

Dichlobenil (at 22.5 kg/ha) was slightly mobile in sand (5% OM) and loam soil (3.2% OM columns
(30 cm) with 84.9% and 87% of the applied, respectively, detected in the 0-12 cm depth.  Dichlobenil
was mobile  in silt loam (1.8% OM) soil columns with 68.7% of applied detected in the 0-12 cm
depth.  The amount of radioactivity detected in the leachate from the sand, loam, and silt loam soils
was 0, 0.55 and 16.0% of the applied, respectively.  After aerobic aging (30 days) of the treated silt
loam soil, 85.65% of the applied was detected in the 0-12 cm depth, and 0.3% in the leachate. The
degradate 2,6-dichlorobenzamide (BAM) was detected in the 25-30 cm column  segment at 28% of
applied. Adsorption appeared to be correlated with organic matter content.  Soil Column Leaching
(parent/unaged); (MRID 00151561).

Based on column leaching studies aged (31 days) dichlobenil residues were determined to be mobile
(3% of applied was found  in leachate) in a column of sandy loam (1.5% OM) treated with 73.8 mg
[14C] dichlobenil equivalence of residues and leached with 52 cm of deionized water.  Following
leaching, approximately 10.7% (7.93  mg) of the radioactivity applied to the column remained in the
treated soil layer,  approximately 12-15 mg (approximately 17.5% of the applied) were in each of the
top three 2-cm soil segments (totaling 52.6% in the 1  to 7 cm column depth); 12.6 mg were in the
7 to 9 cm depth; <7.2 mg were in the 9 to 11 cm depth; and <1.1 mg were in the 11  to 13 cm depth
(28.4% in the 7 to 13 cm depth).  Total residues in the remainder of the column were <1% of the
applied.   In the entire column (including the treated soil  layer), extractable and  unextracted
[14C]residues comprised 85.9% (63.41 mg) and <7.0% (<5.2 mg) of the applied, respectively.  In the
treated layer plus  upper 10 cm of the soil column, [14C]dichlobenil comprised 87-92% of the applied
and the degradate 2,6-dichlorobenzamide comprised <1.8-3.7%; deeper soil segments were not
analyzed for specific compounds. The material balance for the column was 93% of the applied.
(MRID 41709802). The guideline requirement is fulfilled.  (MRIDs 0004925; 40600604; 43006800;
43611101; 00151561; 41709802).

Laboratory Volatility

Dichlobenil (4G) rapidly volatilized in a sandy soil with the highest concentration measured 24 hours
posttreatment (313 |ig/m3 in tube  A).  By 96 hours posttreatment the concentration in tube A
decreased to 49 |ig/m3. The volatility rate decreased from 0.15 to 0.05 |ig/cm2/hr during the test
period of 96 hours.  By 4 days posttreatment, an average of 35% of applied dichlobenil had been
volatilized. This guideline requirement is fulfilled. (MRID 43754001).

Field Volatility

This guideline requirement was waived in the Registration Standard 10/22/86.
                                           55

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                           (3)    Accumulation

Bioaccumulation in fish

Bluegill sunfish exposed to 0.14 mg/1 dichlobenil for 28 days showed maximum bioconcentration
factors of 32X, 63X and 110X for fillet, whole fish and viscera respectively, within 1 day depuration
of the 14 day depuration period, there was a 89% loss of radioactivity in the fillet, 85% in the whole
fish, and 87% in the viscera. The data requirement is fulfilled. (MRIDs 40465801; 40465802).

Bioaccumulation in aquatic non-target organisms

Dichlobenil accumulated in edible (fillet) and nonedible (viscera) tissues of rainbow trout, largemouth
bass, and brown bullhead catfish that were exposed to dichlobenil (10% G) applied at 15 Ib ai/A to
a pond in Oregon. Maximum bioconcentration factors for edible, nonedible, and whole fish tissues
were 12X, 35X, and 27X for rainbow trout;  10X, 17X, and 15X for largemouth bass; and 14X, 21X,
and 17X,  respectively, for brown bullhead catfish.  The degradate, 2,6-dichlorobenzamide, was
detected in largemouth bass nonedible and whole fish tissues at maximum concentrations of 0.028
and 0.021 ppm, respectively, and was not detected (<0.01 ppm) in edible tissues. In brown bullhead
catfish, 2,6-dichlorobenzamide was detected at day 0 only at 0.015 and 0.013 ppm in nonedible and
whole fish tissues, respectively, and was not detected (<0.01 ppm) in edible tissues.  In rainbow trout,
the degradate was not detected in edible tissues (<0.01 ppm) or nonedible tissues (<0.05 ppm).
(MRID 41877301)

Dichlobenil accumulated in edible (fillet) and nonedible (viscera) tissues of bluegill sunfish, channel
catfish, and largemouth bass that were exposed to dichlobenil (10% G) applied at 15 Ib ai/A to a pond
in Florida.  Maximum bioconcentration factors for edible, nonedible, and whole fish tissues were 22X,
55X, and 40X for largemouth bass; 20X, 28X, and 22X for channel  catfish; and, 13X, 29X, and 22X
for bluegill sunfish.  The degradate, 2,6-dichlorobenzamide, was not detected in any of the fish
tissues. (MRID 41780601).  The data requirement is fulfilled. MRIDs 40465801; 40465802.

                           (4)    Field Dissipation

Terrestrial Field Dissipation

Dichlobenil (4G) dissipated with a calculated half-life of 3.7 months from the upper 3 inches of a
loamy sand soil in an established commercial apple orchard located in the Town of Huron, New York;
the orchard was treated with dichlobenil (Norosac, 4% G) at 6 Ib ai/A on May 18, 1987. Dichlobenil
was detected to a 12-inch depth in the treated plots. The degradate 2,6-dichlorobenzamide (BAM)
was detected to a depth of 72 inches. The soil was not sampled deep enough to determine the extent
of leaching of BAM. (MRIDs 41170801; 43006800).
                                           56

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Dichlobenil (4G) dissipated with a calculated half-life of 16 days from the upper 3 inches of Hanford
sandy loam soil located in Madera, California.  A loss of 80% of the applied dichlobenil was not
accounted for after a 7-day period and was attributed to volatilization. Dichlobenil was detected at
a 6-inch soil depth in the treated plots.  The degradate 2,6-dichlorobenzamide was consistently
detected to a 48-inch soil depth. (MRIDs 41149502; 412808023; 43006800).

Dichlobenil (4G) dissipated with a calculated half-life of 241 days from the upper 3 inches of silt loam
soil in field plots that were planted to arborvitae in Hillsboro, Oregon.  The average dichlobenil
concentrations from the deeper soil layers were < 0.024 ppm at all sampling intervals except for 0.084
ppm in the 48 inch to 58 inch depth. There were dichlobenil detections at 36-48, 48-50, and 50-60
inches.  The detections at 50-60  inches were  attributed to contamination.  The degradate 2,6-
dichlorobenzamide, was detected to a depth of 96 inches (deepest sampled). (MRID 41385601).  This
guideline requirement is fulfilled for the (4G) formulation. (MRIDs 41170801; 43006800; 41149502;
41280802;  43006800 and 41385601).

The terrestrial field dissipation data requirement for dichlobenil 50% WP formulation has been waived
due to the use pattern of the formulation being limited to prepaving under asphalt and sewer lines.

Aquatic Field Dissipation

Dichlobenil (10G) dissipated from pond water  with a calculated half-life of 15 days following a
surface application  (15 Ibs ai/A)  to a pond located near Bascom, Florida.  Average dichlobenil
concentrations in water samples taken 1-2 feet from the pond bottom were 0.11 ppm immediately
post-treatment, 0.19 ppm at 7 days, 0.093 ppm at 21 days and were not detected by  84 days post-
treatment.   Dichlobenil  was  detected  to the 6-  to 12-inch depth.   The  degradate,  2,6-
dichlorobenzamide, was not detected in the water or sediment (detection limit is 0.01 ppm). (MRIDs
41780601;  42191401).

Dichlobenil (10G) dissipated from pond water  with a calculated half-life of 69 days following a
surface application of dichlobenil at 15 Ib ai/A to a pond located near Philomath, Oregon.  Average
dichlobenil  concentration in water samples taken 1-2 feet from the pond bottom were <0.01 ppm (not
detected) immediately posttreatment, 0.16 ppm  at 14 days, 0.043 ppm at 59 days, 0.084 ppm at 84
days,  and 0.011 ppm at 182 days posttreatment.  The degradate 2,6-dichlorobenzamide was not
detected in any of the water  samples  (detection limit is 0.01  ppm).  In the  sediment fraction,
dichlobenil dissipated with a calculated half-life of 39 days.  Dichlobenil and the degradate, 2,6-
dichlorobenzamide, were detected to a depth of 12 inches. (MRIDs 41877301; 42191401).

Forestry Dissipation

A risk assessment for the use of dichlobenil on hybrid cottonwood-poplars in pulpwood production
areas  in this RED was performed on the assumption that the use was limited to the pulpwood
production areas of the eastern Oregon-Washington desert which is defined as 15 miles from the
Columbia river in the counties of Walla Walla, Franklin and Benton in Washington and Umatilla and
                                            57

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Morrow in Oregon. The cultivation of cottonwood-poplar hybrids grown at these sites is not
considered a forestry use because the trees are grown as a row crop with drip irrigation in a dessert
setting on land previously used to cultivate row crops.  However, the registration on cottonwood
hybrid poplars has recently been expanded under section 3 of FIFRA to include regions outside of
this limited area.

The forestry dissipation study is required to enable the Agency to assess the risks from the use of
dichlobenil in all hybrid cottonwood-poplar pulpwood production areas.  Alternatively, registrants
may waive this data requirement if they limit the use of dichlobenil on hybrid cottonwood-poplar
plantations to the areas in Oregon and Washington as defined above.

The other registered use sites, including shelterbelts were not considered forestry use.  The
cottonwood-poplar hybrid plantations and shelterbelt use sites were not considered forestry use.

                            (5)    Spray Drift

The droplet size spectrum/drift  field evaluation studies have been waived due to the minimal spray
drift of the aerial application of the large mesh size dry 4G granules.

                     b.     Water Resources

                            (1)    Ground Water

The Office of Pesticide Programs (OPP) evaluates the persistence and mobility of each pesticide for
ground  water concerns.   If the data indicate that the parent and/or degradates are persistent and
mobile, then a small-scale prospective ground water study  may be requested. The basic triggering
criteria include: weight of the evidence from laboratory and field dissipation studies indicating that
the pesticide has properties and  characteristics similar to  pesticides that are known to leach or have
been detected in ground water; movement of the parent or degradates 75-90 centimeters through the
soil profile or plow layer in a field dissipation study; reports of detections in ground water from other
monitoring studies and information about toxicity.  In addition, use patterns, application rates, timing
of application, potential acreage treated, depth to ground water, soil types, hydraulic gradient, and
climate are also evaluated as part of the triggering criteria.  Persistence, mobility, and detections in
ground water are also used to evaluate a chemical to determine whether its use should be restricted
for ground water concerns. A pesticide may be recommended as a candidate for Restricted Use if
it  exceeds one or more  characteristic for each of the three factors (persistence, mobility and
detections).

Persistence and Mobility

Dichlobenil was evaluated for persistence and mobility in relation to its potential to leach to ground
water. Below is a summary of that  evaluation.
                                             58

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  Table 21   Mobility and Persistence of Dichlobenil Relative to Restricted Use Criteria
FACTOR
PERSISTENCE
MOBILITY
CHARACTERISTIC
Field dissipation half-life
Lab-derived aerobic soil metabolism half-life
Hydrolysis half-life
Photolysis half-life (soil)
Soil adsorption: Kd
Soil adsorption: Koc
Depth of leaching in field dissipation study
RESTRICTED USE
CRITERIA
> 3 weeks or
> 3 weeks or
< 10% in 30 days or
< 10% in 30 days and
< 5 ml/g or
< 500 ml/g or
75 cm
REPORTED VALUE(S)
2.3, 14.8, 34 weeks
46.3 weeks (calculated)
stable
(calculated 50% in >150 days)
stable
0.3,2.1 - 10.5 ml/g
49, 114-323 ml/g
152 cm (60 inches)
                       | .  I      Shaded value indicates that parameter exceeds trigger
                                   * Does not include degradate data.

Depth of leaching in field dissipation study

In one field dissipation study, the maximum reported depth of dichlobenil residues was reported to
be in the 50-60 inch sampling depth (60 inches =152 cm). The registrant attributed these detections
to contamination, however there were also detections at the 36-48", and 48-50" depth. Other studies
found the parent dichlobenil at the 12" depth and 6" soil depth. These studies also sampled for the
degradate BAM and residues were detected at depths of 48",72", and 96" in three studies. The study
detecting residues at 72" did not sample  deep enough to determine the extent of leaching of BAM.
The study detecting residues at 96" was the deepest sample taken for analysis, and this supports
conclusions that the degradate BAM is more mobile than the parent.

Volatilization

OPP has concluded that volatilization may be a significant dissipation pathway.  Volatilization of
dichlobenil appears to be controlled by soil moisture  content and temperature.  Inadequate soil
moisture, or the lower temperatures associated with  northern  use  areas will allow  more of the
compound to remain in the soil and be available for leaching. The mobility of the parent dichlobenil
is correlated with the organic matter content of the soils.  OPP concludes that under some conditions,
inadequate soil moisture, low temperatures, or low soil organic matter, dichlobenil or its degradate
BAM, are likely to leach to ground water.

Ground Water Detections

To date,  there has been extremely limited monitoring for dichlobenil in ground water in the United
States. The "Pesticides in Ground Water Database" (Hoheisel  et al.,  1992) reports sampling for
dichlobenil in only one well in California in 1987.  No residues were detected in this one well, but no
                                            59

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MCL or HA was established and no information is available about the details of the monitoring.  A
summary of this is presented below.
  Table 22
Summary of Ground Water Detections
CRITERION
DETECTIONS
CHARACTERISTIC
Number of wells per state with detections
Number of counties with detections > 10%
of reference point
RESTRICTED USE
CRITERIA
25 wells in 4 or more states or
3 counties at >10% of MCL or
HAL
REPORTED DETECTIONS
No Data
No MCL or HA Established
                              shaded value indicates parameter exceeds trigger
In 1994, the previous dichlobenil basic producer requested that the label advisory and prospective
ground-water monitoring study be waived.  To support their claim that these regulatory measures
were not needed, a document summarizing monitoring information for dichlobenil in The Netherlands
and lysimeter studies in Germany were submitted.

The monitoring information for The Netherlands is summarized below:
         Table 23     Netherlands Monitoring Information
Type of Sample/Date
Surface Water, 1987
Tap Water, 1987
Tap Water (Ground Water), 1989-1990
Ground- Water Pumping Stations, 1991
Ground Water, 1988-1990
Dichlobenil Concentration
<0. 01-0. 097 ppb
No detections


up to 0.12 ppb
BAM Concentration
not analyzed
not analyzed
No detections
up to 0.30 ppb
up to 1 80 ppb
As  seen above, residues of dichlobenil and BAM have both been detected in ground water and
dichlobenil has been detected in surface water in the Netherlands. Residues  of BAM have been
detected up to 180 ppb in an area of shallow ground water (approximately 5 feet).

In 1990, three undisturbed sandy soil cores were removed from a field and installed in Schmallenberg,
Germany.  These soil core  "lysimeters" were monitored for two years, after which they were
sectioned and analyzed. Parent dichlobenil did not occur in any of the leachate above the limit of
quantification of 0.047 ppb.  BAM was found in the leachate of all three lysimeters with average
concentrations of 14.2 ppb (2.7 kg/ha application rate), 51.7 ppb (4.0 kg/ha application rate), and
80.4 ppb (8.1 kg/ha application rate). BAM was also detected in nearly all soil layers. The report
states that "results demonstrate that  the metabolite 2,6-dichlorobenzamide (BAM) has a higher
potential to reach groundwater than the parent compound."
                                            60

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Considering the widespread use of dichlobenil, its chemical and physical parameters, and the wide
range of use conditions, OPP believes that dichlobenil will be detected in ground water if more
monitoring is conducted.

Dichlobenil meets all the persistence and mobility  triggers  for recommending Restricted Use
classification based on ground-water concerns. At the present time, dichlobenil is not a candidate for
Restricted Use classification because insufficient monitoring information is available in the United
States.   Considering the wide spread use of dichlobenil and the wide range of use conditions, we
believe that more monitoring data will find more detections of dichlobenil and/or BAM in the ground
water.  OPP has concluded that dichlobenil probably would exceed the detections trigger for
Restricted Use classification with  additional monitoring data.

Ground-Water  Concerns

Based on the limited data available, OPP  concludes that dichlobenil and BAM have the potential to
exceed levels of concern for ground water quality.  However, the available monitoring data in the
United States is insufficient at this time.

GROUND-WATER QUALITY. OPP is concerned about the potential degradation of ground-water
quality that may  occur in  areas where dichlobenil is used.  Dichlobenil is registered for a variety of
terrestrial uses and considering the persistence and mobility of both dichlobenil and BAM, these
chemicals are likely to leach to ground water in vulnerable  areas. In addition,  after reaching ground
water it  can persist because  of its resistance to  abiotic  degradation  and its  resistance  to
microbiological degradation coupled with the low microbiological activity  of most groundwater.

HUMAN EXPOSURE. Dichlobenil and BAM are extremely mobile and persistent under anaerobic
conditions.  Considering the wide spread use of dichlobenil and the wide range of use conditions, we
believe that more monitoring data will find more detections in ground water.

Because OPP's ground water concerns are focused on the potential occurrence of BAM in drinking
water and the resulting possible human exposure, OPP is requiring a drinking water monitoring study.

The proposed drinking water monitoring study should have samples from  existing drinking water
wells. The samples should be from drinking water wells in dichlobenil use areas and taken as close
as possible to treated fields. Samples should be analyzed for both the parent and the degradate BAM.
When possible, sampling should include, but not be limited to, wells near cranberry fields, nurseries,
and several non-ag uses such as rights-of way, hedge/fence row treatment and home owner use,
however not sewers and "under asphalt." All studies must use protocols that have been reviewed and
approved by all parties. The drinking water study results will be used to determine if any additional
ground water mitigation measures or prospective ground water studies are needed.

OPP has evaluated the potential for dichlobenil to reach groundwater in the  proposed hybrid poplar
pulpwood production sites in the eastern Oregon-Washington  desert which is defined as 15 miles
                                            61

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from the Columbia river in the counties of Walla, Franklin and Benton in Washington and Umatilla
and Morrow in Oregon and has concluded that risk to ground water is relatively low in these areas.
The registration of cottonwood hybrid poplars has recently been expanded under section 3 of FIFRA
to include regions outside of this limited area. The Agency is concerned about expanding dichlobenil
use to areas considered vulnerable to ground water contamination. If the use of dichlobenil for
pulpwood  production is extended  beyond the above defined production areas in Oregon and
Washington, then one or more small-scale prospective groundwater studies need to be conducted.
Alternatively, the registrant may limit the use of dichlobenil on hybrid poplar pulpwood production
sites to the desert areas of eastern Oregon and Washington as defined above.

                            (2)    Surface Water

Dichlobenil and its metabolite BAM have the potential to contaminate surface water from runoff or
spray drift associated with ground application. There are insufficient data for BAM to determine
presence in surface water. However,  results of two aquatic field dissipation studies conducted in
Bascom, Florida and Philomath, Oregon indicate dichlobenil is slightly to moderately persistent
(DT50s  of 15-69 days)  in surface waters.  Using the results from the aquatic field studies and
integrating the laboratory data, dichlobenil dissipates from surface waters primarily by volatilization
with limited sorption to sediment and slow microbial biotransformation to BAM or DCBA. Minimal
binding to sediment was found; dichlobenil or the degradate BAM were detected in sediment samples
to the 12-inch depth. However, dichlobenil should not bioaccumulate, as shown in a bioaccumulation
in fish study and from the log Kow of 2.90.

Transport of dichlobenil in the dissolved phase during surface runoff events which occur soon after
application should not be substantial because of its high potential to volatilize. Dichlobenil was not
persistent in the laboratory aerobic aquatic environment (half-life of 2.4 days).   In anaerobic
environments such  as sediments in stream and lake bottoms, dichlobenil is persistent (anaerobic
aquatic metabolism half-life  2.85  years).  The low to intermediate soil/water partitioning coefficients
for dichlobenil (Kds of 0.3-10.5 ml/g; Kocs of 49-323) indicate that granular released dichlobenil in
surface runoff would occur primarily dissolved in the runoff as opposed to that adsorbed onto eroding
soil or entrained in sediment. Volatilization of dichlobenil from  surface waters is considered the most
important route  of dissipation based on the acceptable study results and its vapor pressure (5.5 x 10"4
mm Hg at 25° C) and Henry's Law constant (6.6 x 10"6 atm-m3/mol, estimated). From the findings
of the bioaccumulation in fish study,  and supported by its low octanol/water partitioning coefficient
(log Kow = 2.90), dichlobenil should not bioaccumulate.

To  model  BAM in surface water,  additional data on BAM's vapor pressure and solubility are
required. If these data demonstrate that the Henry's constant for BAM is less than 10"5, it indicates
that BAM does not volatilize from surface water and additional environmental fate data will be
required including guidelines:
       161-2 Photodegradation in water
       162-1 Aerobic soil metabolism
                                            62

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       162-4 Aerobic aquatic metabolism
       163-1 Adsorption/desorption

If Henry's constant does not exceed 10"5 these additional data would not be required because that
would indicate that BAM will volatilize from surface water.

Dichlobenil is not currently regulated under the Safe Drinking Water Act (SDWA); therefore, a
Maximum Contaminant Level (MCL) is not established. Public water supply systems are not required
to sample and analyze for dichlobenil. Dichlobenil is classified in Toxicity Category III for Oral Acute
Toxicity and has been classified as  a Group  C - possible human carcinogen  by  the  OPP
Carcinogenicity Peer Review Committee (document dated 8/30/91). A RfD of 0.013 mg/kg/day for
dichlobenil was established earlier from a 2-year dog feeding study; however, the degradate BAM
(also a major residue detected in plants) is the appropriate material for dietary exposure. The RfD of
0.015 mg/kg/day was established for BAM was established from the 2 year dog feeding study.

Although dichlobenil has the potential to contaminate surface water from runoff and spray  drift,
limited surface water monitoring information is available at this time.

A summary of the dichlobenil detections in the STORET database are listed in Table 24.  The
maximum concentration of dichlobenil was 0.32 //g/L (ppb) for a filtered  surface water sample
collected on the South Platte River in Colorado. In filtered surface water samples, 5 detections  were
reported for 36  samples with the concentrations of dichlobenil ranging from  0.04 to 0.32 //g/L.
  TABLE 24    Summary of Dichlobenil Detections in Storet Database
SITE NAME
Fanno Creek,
OR
South Platte
River, CO
MONITORING PERIOD
4/12/93 - 8/10/95
12/13/93 - 8/10/94
DETECTIONS/ SAMPLES
4/21
1/15
DETECTION
LIMIT Og/L)
0.03
0.05
RANGE OF
CONCENTRATIONS -- /ig/L -
0.04-0.3
0.32
EPA used GENEEC, a computer program model, to calculate generic EECs based on runoff from
a 10 hectare field to a  1 hectare water body, 2 meters deep.  This model is designed based on the
assumption that off site drift is minimal from granular formulations. These generic EECs also take
into account degradation in the field prior to a rain event.

The estimated results of the Tier 1 Aquatic EEC modeling with GENEEC are listed in Table 25.  For
the simulations without soil-incorporation of dichlobenil, the range of aquatic EECs was 95 //g/L for
2 Ibs ai/A to a maximum of 951 //g/L at 20 Ibs ai/A, and the peak EEC varied by a factor of  47.5
Mg/L for each pound increase in dichlobenil. For the model results with soil-incorporation to 2 inch
depth, the maximum EEC was estimated to be 476 //g/L,  and the peak EEC changed by  23.8
//g/L/lb-ai/A for each pound of dichlobenil applied.  Comparison of the simulation results between
unincorporated and soil-incorporated to 2 inches suggests aquatic EECs for dichlobenil are lowered
                                           63

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by approximately one-half following soil incorporation.  It is important to note that the GENEEC
program does not directly incorporate volatilization into the model.  Although the  laboratory
metabolism half-lives used in GENEEC partially reflect losses due to volatilization, they do not
completely account for volatilization.  Dichlobenil dissipates primarily by volatilization; therefore, the
aquatic EECs reported for dichlobenil would be considered as maximum values because dissipation
by volatilization was not completely reflected in the input to the model.  Also, assumptions made in
GENEEC concerning losses due to runoff are very conservative.  The amount in surface water will
probably be lower and dependent on climate and environmental conditions.

The following data were used for the GENEEC program:

        - Koc for silt loam soil with 0.6% organic matter = 49
        - Solubility = 25 ppm
        - Aerobic aquatic metabolism half-life = 2.4 days
        - Aerobic soil metabolism half-life = 322 days in sandy loam.
        - Photolysis half-life =15 days
        - Soil incorporation = 2 inches
   TABLE 25.    GENEEC Aquatic Estimated Environmental Concentrations for Dichlobenil
NOT SOIL-INCORPORATED
RATE
(Ibs ai/A)
2
4
6
8
20
PEAK EEC DAY 4 EEC DAY 21 EEC
— //g/L —
95 65 18
190 129 36
285 194 54
380 259 72
951 648 180
DAY 56 EEC

7
14
20
27
67
SOIL-INCORPORATED TO 2 INCHES
RATE
(Ibs ai/A)
2
4
6
8
20
PEAK EEC DAY 4 EEC DAY 21 EEC
— /ig/L —
47 32 9
95 65 18
141 96 27
190 130 36
476 324 90
DAY 56 EEC

3
7
9
14
34
Soil incorporation reduces aquatic exposure by approximately one half. In addition, dichlobenil
exhibits high volatility in water and volatility is not a parameter of GENEEC.  Therefore, it is
                                           64

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expected that the 4-, 21-, and 56-day average exposure values are lower than those calculated in the
table above.

                     c.     Environmental Fate Assessment

Dichlobenil dissipates in the environment (on soil and in surface water) principally by volatilization.
However, it is persistent under field conditions that reduce the potential for volatilization (i.e. cooler
climates).  When degradation proceeds through aerobic soil metabolism, 2,6-dichlorobenzamide
(BAM) is generated (13.1% at 50 weeks). Under conditions where dichlobenil does not volatilize
there is potential for both dichlobenil and BAM to move to ground water in coarse-textured soils low
in organic matter.

Generally, any dissipation that took place in both laboratory and field studies was a result of
volatilization of parent compound.  This is consistent with a vapor pressure of 5 x 10"4 mm Hg at
25°C  and  a Henry's Law  constant of 6.6 x 10"6  atm-m3/mol, and the relatively  low soil/water
partitioning.    Dichlobenil was stable to hydrolysis,  photodegradation in soil  and metabolic
degradative processes.  Dichlobenil was very persistent in  the aerobic soil metabolism (half-life of
46.3 weeks) and the anaerobic aquatic metabolism (half-life of 2.8 years) studies.

Adsorption/desorption studies indicated that dichlobenil can  be mobile with Kads ranging from 0.2 to
10.5. Dichlobenil has a moderate water solubility of 25 ppm at 20°C. Adsorption was correlated with
the organic matter content of the soils. Soil column leaching studies indicated that dichlobenil was
mobile in silt loam and sandy loam and slightly mobile in sand and loam soil.

Bioaccumulation in fish testing indicated that dichlobenil has a low potential to bioaccumulate
(maximum BCF 32X, 63X and 110X for fillet, whole fish and viscera, respectively) and a high rate
of depuration (within 1 day of the 14 day depuration period, there was a 89% loss of radioactivity
in the fillet, 85% in the whole fish, and 87% in the viscera).

Studies in the field were consistent with lab study results with volatilization occurring more readily
in warmer climates. A field dissipation study conducted in  California yielded a dissipation time for
50% of dichlobenil (DT50) of 16 days. When dichlobenil is used under similar conditions (limited
amount of rainfall expected) it would not pose a threat to ground water.  However, in warmer
climates where a large amount of the compound would dissipate through volatilization, dichlobenil
may drift off-site.

When conditions are not conducive to volatilization, ie., cooler temperatures, as was encountered
during the terrestrial field dissipation study conducted in Oregon, (half-life of 241 days) dichlobenil
when applied to sandy soils of low organic matter could be persistent and mobile enough to migrate
to lower soil depths where the compound is stable (anaerobic aquatic metabolism  half-life of 2.8
years). Use of dichlobenil under these conditions could potentially cause ground water contamination.
After reaching ground water it could persist because of its  resistance to abiotic degradation and its
                                            65

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resistance to microbiological degradation coupled with the low microbiological activity of most
groundwater.

The main aerobic soil metabolism degradate (BAM) was consistently detected at the lowest soil
depths sampled in the terrestrial field dissipation study (up to 96 inches, which in that field study was
the deepest sampling depth). The soils in the terrestrial field dissipation study were only analyzed for
dichlobenil  and BAM.  In two  previously reviewed  aerobic soil metabolism studies the major
degradate was also BAM. However, BAM did not concentrate on the surface of the soil. Two other
degradates, 2-6-dichlorobenzoic acid (DCBA) and an unidentified compound, were isolated.  DCBA
is another highly mobile compound that is a degradation product of dichlobenil.

Dichlobenil  and its major degradate (BAM) exhibit many of the properties and characteristics
associated with chemicals that have been detected in ground water. Dichlobenil  can be extremely
mobile and moderately to highly  persistent under aerobic conditions. Under anaerobic conditions,
the half-life for parent dichlobenil is 2.8 years, indicating that it will persist for extremely long periods
of time once it reaches ground water. BAM appears to be more mobile than the parent compound.
Dichlobenil was detected in a field dissipation study to a depth of 60 inches. BAM was detected in
the same study, to a depth of 96 inches, the maximum sampling depth (USEPA,  1993). For these
reasons, dichlobenil use is likely to have a significant impact on ground-water quality in certain areas.

Dichlobenil is slightly- to moderately-persistent in surface waters (aquatic field dissipation half-lives
in  water ranging from 15-69 days) since it is stable to  degradation from abiotic hydrolysis and
aqueous photolysis. Limited microbial-mediated metabolism of parent dichlobenil and the degradate
BAM occurs in aerobic soil environments. Dichlobenil may slowly transform by microbial-mediated
metabolism  or possibly  alkaline  hydrolysis to the degradate BAM (2,6-dichlorobenzamide). The
compound BAM may be transformed to the degradate DCBA (2,6-dichlorobenzoic acid). Based on
the Freundlich adsorption coefficients, dichlobenil does not adsorb significantly to soil particles and
runoff to surface water may be  primarily by way of dissolution  of dichlobenil in runoff water.
However, soil/water partition coefficients > 1  suggest that the concentration of dichlobenil adsorbed
to  suspended and bottom sediment will be greater than that dissolved in the water column. Both
major transformation products, BAM and DCBA, are less strongly adsorbed to soil or sediment than
dichlobenil.  Consequently, their runoff is also primarily by way of dissolution in runoff water as
opposed to adsorption to eroding soil.  Dichlobenil has the potential to contaminate surface water
from runoff or spray drift associated with ground spray application. In surface waters, dichlobenil
dissipates principally by volatilization with some biotransformation and binding to sediments.  Limited
monitoring  data for surface waters are summarized in  Table 24.  The modeling results for aquatic
EECs from  GENEEC Tier  1 aquatic  EEC modeling  are briefly  discussed  in the Surface Water
Assessment  of the Environmental Fate and Transport section.
                                            66

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              3.      Ecological Exposure and Risk Characterization

Explanation of the Risk Quotient (RQ) and the Level of Concern (LOG):

Levels of Concern are criteria used to indicate potential risk to nontarget organisms. Exceeding the
criteria indicates that a pesticide, when used as directed, has the potential to cause undesirable effects
to nontarget organisms. Two general categories of LOG (acute and chronic) exist: one for each of
the four nontarget faunal groups and one category for each of two nontarget floral groups. To
determine if an LOG has been exceeded, a risk quotient is derived and compared to the LOCs. A risk
quotient is calculated by dividing an appropriate exposure estimate, e.g. the estimated environmental
concentration (EEC), by an appropriate toxicity test effect level, e.g. the LC50.

The acute effect levels are:

              - EC25 (terrestrial plants)
              - EC50 (aquatic invertebrates)
              - LC50 (fish and birds)
              - LD50 (birds and mammals)

The chronic effect levels are:

              - NOEC (avian and mammalian reproduction studies)
              - NOEC or MATC for aquatic species.

The effects levels for plants are:

              - EC25 (terrestrial and semi-aquatic plants)
              - EC50 (aquatic plants)
              - NOEL or EC05 (for endangered plants)

When the RQ exceeds the LOG for a particular category, risk is presumed. Risk presumptions, along
with the corresponding LOCs, are identified below.
                                            67

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Levels of Concern (LOG) and Associated Risk Presumption
     Birds and Mammals
 IF THE            LOG        PRESUMPTION
 Acute RQ>         0.5          Potentially High Acute Ri sk
 Acute RQ>         0.2          Restricted Use Candidate
 Acute RQ>         0.1          May Effect Endangered Species
 Chronic RQ>        1           Chronic Risk,
                                May Affect Endangered Species
     Fish and Aquatic Invertebrates
 IF THE	LOG	PRESUMPTION	
 Acute RQ>         0.5          Potentially High Acute Ri sk
 Acute RQ>         0.1          Restricted Use Candidate
 Acute RQ>         0.05         May Effect Endangered Species
 Chronic RQ>        1           Chronic Risk, May Affect Endangered Species

     Terrestrial and Semi-aquatic Plants
 IF THE	LOG	PRESUMPTION	
 EEC/EC25>         1           Potentially High Risk
 EEC/NOEL or      1           May Effect Endangered Species
 EEC/EC05>
     Aquatic Plants
 IF THE	LOG	PRESUMPTION	
 EEC/EC50>         1           Potentially High Risk
 EEC/NOEL or      1           May Effect Endangered Species
 EEC/EC05>
At this time, OPP does not require data which would allow quantitative assessment for reproductive
risk to plants, or acute or chronic risks to nontarget insects. Chronic risk to mammals from granular
dichlobenil was evaluated qualitatively.
                                        68

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Dichlobenil Use Patterns Addressed in Risk Assessment

Application rates, and the associated use sites, used in estimating RQs are identified below:

       - 2 Ib ai/A is used on turf (dichondra).
       - 4 Ib ai/A is used on blackberry, raspberry, cranberry (spring application), and cottonwood
       hybrids (pulp).
       - 6 Ib ai/A is used on cranberry (fall application), blueberry, cherry, apple, grape, filbert, and
       pear.
       - 8 Ib ai/A is used on ornamental/shade tree, ornamental woody shrubs     and vines, and
       shelterbelt planting.
       - 20 Ib ai/A is used on landscaping rights-of-way, fencerow, hedgerow,    residential and
       commercial landscaping, cemeteries, and in industrial and recreational areas.

These granular formulations are expected to result in exposure to nontarget organisms. Dichlobenil
is formulated into three granule sizes; Two of which are 4% ai and one is 10% ai.  According to the
registrant, the smaller granule of the 4% granule formula (4G) (16/30 size), contains approximately
0.0216 mg ai/granule; the larger granule of the 4G (8/30 size), contains approximately 0.1528 mg
ai/granule. According to information provided by Uniroyal and FBI Gordon, the large granule of the
4G is applied by air, the smaller granule of the 4G is applied by ground equipment or air. The 10%
ai granule (10G) is 8/16 mesh size and contains approximately 0.3276 mg ai/granule.

Non-granular formulations, used to treat under pavement and in sewage systems, are not expected
to result in exposure to non-target organisms.

                     a.      Exposure and Risk to Nontarget Terrestrial Animals

                            (1)     Birds

Birds may be exposed to granular pesticides by intentionally or inadvertently ingesting granules when
foraging for food or grit.  They also may be exposed by other routes,  such as by walking on exposed
granules or drinking water contaminated by granules.  The risk  quotient for birds for  granular
pesticides is calculated by dividing the mg ai/ft2 by the LD50 in  mg ai/bird.  Risk quotients are
calculated for a 180-gram bird (e.g., quail).
                                            69

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      Table 26  Avian Acute Risk Quotients for Granular Applications of Dichlobenil, both
                        Broadcast (Unincorporated) and Incorporated
Lbs ai/A
2
4
6
8
10
20
Risk Quotients
Based on Bobwhite LD50 of 683 mg/kg (122 mg for a 180 gram bird)
Unincorporated
EEC"
mg/sqft
21
42
63
83
104
208
RQ based on LD50 of
122 mg per bird
0.2*
0.3*
0.5**
0.7***
0.85***
1.7***
Incorporated"
EEC"
mg/sqft
3
6
9
12
16
31
RQ based on LD50 of
122 mg per bird
<0.1
<0.1
<0.1
<0.1
0.13*
0.3**
       " It is assumed that only 15% of the applied ai is exposed after incorporation. This assumption is based on dichlobenil being lightly incorporated
       into the soils.
       b mg/sq ft = Ibs ai/A X (453590 mg per Ib / 43560 ft2 per acre).
       *       Exceeds Endangered Species LOG
       **     Exceeds Restricted Use LOC
       ***     Exceeds High Acute Risk LOC

Based on LD50s/ft2, unincorporated application at 2 Ibs ai/A and higher exceeds the LOCs for effects
to endangered bird species feeding on the ground. The LOC for restricted use and potentially high
acute risk to birds is exceeded at application rates equal to or above 6 Ib ai/A and 8 Ib ai/A,
respectively.  The RQ  for soil incorporated applications at 10 Ibs ai/A exceed the LOC for effect to
endangered species and at 20 Ibs ai/A exceed the LOC for restricted use.

However, likelihood of hazardous exposure to birds also depends on how many granules it would
take to exceed the LOC. Two granular formulations were assessed (4G and 10G) for potential risk
to birds.

Avian Assessment of 4G Granulars

According to the registrant, the 4G formulation comes in two sizes, a smaller granule (16/30 size)
which contains approximately 0.0216 mg ai/granule; and the larger granule (8/30 size) which contains
approximately 0.1528 mg ai/granule.  The larger granule is still small enough to be easily swallowed
by a small bird.

Using the bobwhite LD50 of 683 mg/kg, the estimated LD50 for a 20 gram bird the size of a sparrow
(Dunning, 1984) would be 13.66 mg/bird (683 X 0.02 = 13.66). To take in enough active ingredient
to equal the LOC (0.5  x  LD50) for potential high risk, a sparrow would have to ingest 45 large
granules (0.5 x 13.66/0.1528) or 316 small granules (0.5 x  13.66/0.0216) in one day.  Since the
granules are not considered a food source, ingestion would occur inadvertently as grit.  It is
considered unlikely that a sparrow sized bird would ingest 45 granules, therefore high risk to
birds is considered unlikely at any use rate (Best, 1992).
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To exceed the endangered species LOG, the same sized bird would have to ingest approximately 9
large granules or 63 small granules of the 4G dichlobenil formulation.  It is considered unlikely that
a bird would consume 63 granules in the process of gathering grit, however, it is considered possible
that 9 granules could be ingested in one day.  Therefore, the larger granules of the 4G formulation
may affect endangered birds at a 2 Ib ai/A or higher unincorporated application rate and at
10 Ib ai/A or higher incorporated rate.  The smaller granules, regardless of the use rate, are not
expected to have an acute affect to endangered birds.

Avian Assessment of the 10G Granulars

The 10G granule (8/16 size), contains approximately 0.3276 mg ai/granule.  This size granule is still
large enough to be easily swallowed by a small bird.

Using the bobwhite LD50 of 683 mg/kg, the estimated LD50 for a 20 gram bird the size of a sparrow
(Dunning, 1984) would be 13.66 mg/bird (683 X 0.02 = 13.66). To take in enough active ingredient
to equal the LOG (0.5 x LD50) for potential high acute risk, a sparrow would have to ingest 20 to 21
large  10G granules (0.5 x 13.66/0.3276) in one day.  Since the granules are not considered a food
source, ingestion would occur inadvertently as grit. It is considered reasonable and likely that a
sparrow sized bird would ingest up to 21 granules (Best, 1992). Therefore,  the high potential of acute
risk to birds is considered likely at 6 Ib ai/A or higher when using the 10G formulation.

The  trigger for classifying dichlobenil as a restricted use  candidates  has been exceeded  at all
unincorporated application rates.

To exceed the endangered species LOG, the same sized bird would have to ingest approximately 4
granules of the  10G formulation. It is considered likely that  a bird would consume the granules in
the process of gathering grit in one day. Therefore, the 10G granules may affect endangered birds
at all unincorporated rates of application and at the 10 Ib ai/A or higher incorporated application
rates.

Birds, Chronic

No avian reproduction data are available.

Bird Summary

The relatively low exceedances means the overall acute risk of dichlobenil to birds is low. However,
ground-feeding endangered birds may be affected at all  use rates if these birds ingest the larger
granules, especially the 10G formulations.
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                             (2)     Mammals

Mammalian species may be exposed to granular pesticides by inadvertently ingesting granules.  They
also may be exposed by other routes, such as by walking on exposed granules and drinking water
contaminated by granules.  The number of LD50s that are available within one square foot immediately
after application is used as a risk quotient (LD50s/ft2) for the various types of exposure to granular
pesticides.  Risk quotients are calculated for a 200 gram mammal (e.g. rat).

Risk quotients are presented below.
      Table 27: Mammalian Risk Quotients for Granular Applications of Dichlobenil, both
                         Broadcast (Unincorporated) and Incorporated
Lbs ai/A
2
4
6
8
20
Risk Quotients
Based on Rat LD50 of 4250 mg/kg (850 mg per 200 gram rat)
Unincorporated
EEC"
mg/sqft
21
42
63
83
208
200 gram mammal
LDJO 850 mg
<0.1
<0.1
<0.1
<0.1
0.2
Incorporated "
EEC"
mg/sqft
3
6
9
12
31
200 gram mammal
LDJO 850 mg
<0.1
<0.1
<0.1
<0.1
<0.1
       It is assumed that only 15% ofthe applied ai is exposed after incorporation. This assumption is based on dichlobenil being lightly incorporated
       into the soils.
       b mg/sq ft = Ibs ai/A X (453590 mg per Ib / 43560 ft2 per acre).

No LOCs are exceeded if dichlobenil is soil incorporated.

With unincorporated application, the LOG for effects to small endangered mammals are exceeded at
a use rate of 20 Ibs ai/A. However, several factors are considered that may result in less exposure
of dichlobenil to mammals:

       - Mammals do not intentionally ingest grit and soil. Exposure would occur from dichlobenil
       that is attached to food items or fur.

       - The use sites for 20 Ibs ai/A applications are nurseries, homeowner and landscaping sites.
       Endangered mammals are not expected to inhabit these areas.

       - The 2-generation rat reproduction study indicated that dichlobenil makes the food items
       unpalatable for the  rats.  This suggests that the presence of dichlobenil may discourage
       mammals from feeding in the treated area.
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Therefore, it is concluded that dichlobenil is unlikely to affect endangered mammals.

The major degradate of dichlobenil, BAM, is similar in toxicity to mammals to parent dichlobenil.
The rat LD50 of BAM is 1,470 mg/kg (MRID 00112500) compared to an LD50 of 4,250 mg/kg for
dichlobenil. It is not known precisely how much of dichlobenil transforms to BAM, and of that, how
much remains exposed on the soil surface.  However, BAM is formed slowly as a result of aerobic
soil metabolism, and therefore would not be expected to be concentrated on the soil  surface.
Therefore, exposure to mammals from BAM is expected to be minimal.

Mammals, Chronic

Currently, EPA does not have a formal process for determining chronic risk to mammals from
granular formulations. However, since chronic mammalian toxicity data for dichlobenil technical are
available, an attempt was made to estimate if a chronic impact was possible. It is assumed that if
exposure in the field exceeds NOELs from chronic lab studies, mammals may be chronically affected.
The NOELs range from 3 to 45 mg/kg/day or 60 to 900 ppm.

NOEL (ppm) = NOEL (mg/kg/day) / 0.05 (daily food consumption)

At some point after application, it is assumed that the dichlobenil is released from the clay granule
into the surrounding soil.  Since mammals do not intentionally consume  clay granules or soil,
exposure to mammals would only occur if the granules or soil  containing  dichlobenil attached to a
mammalian food item or if dichlobenil is dissolved in surface water puddles.  If the applied dichlobenil
is mixed with the top 3 inches of soil, the concentration in the soil would be  approximately 0.73 ppm
for each  pound applied  per acre (Ecological Risk Assessment  SEP,  1986).  Therefore,  soil
concentrations would range from 2 to 15 ppm.  It is assumed  the concentrations in food items to
which the soil was attached,  or the water  covering  the treated  soil would not exceed the
concentration in the soil. A minimal likelihood of chronic effects to mammals is  suggested since 2
to 15 ppm of dichlobenil in the soil is substantially lower than the NOELs of 60 to 900 ppm.

The overall risk of dichlobenil to mammals including endangered species is low.

                           (3)    Insects

At this time, EPA has no quantitative procedure for assessing risk to nontarget  insects. Because
dichlobenil is practically non-toxic to honey bees, and is applied only as a granular, exposure and risk
is expected to be minimal.  Because dichlobenil is practically non-toxic to honey bees, no label
restrictions are required.
                           (4)    Exposure and Risk to Nontarget Aquatic Animals

The EECs for aquatic exposure are provided in Table 25.


                                           73

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                                   (a)    Freshwater Fish


  Table 28:  Fish Acute Risk Quotients for Granular Applications of Dichlobenil, both
                   Broadcast (Unincorporated) and Incorporated
Lbs ai/A
2
4
6
8
20
Risk Quotients
Unincorporated
Initial EEC
ppb
95
190
285
380
951
RQ
trout LC50
6260 ppb
0.02
0.03
0.04
0.06
0.15*
RQ
bluegill LC50
83 10 ppb
0.01
0.02
0.03
0.04
0.1*
Incorporated
Initial
EEC
ppb
47
95
141
190
476
RQ
trout LC50
6260 ppb
0.01
0.02
0.02
0.03
0.08
RQ
bluegill LCJO
83 10 ppb
<0.01
0.01
0.02
0.02
0.06
       *      Exceeds Endangered Species LOG
       **      Exceeds Restricted Use LOC
       ***     Exceeds High Acute Risk LOC
Dichlobenil volatilizes rapidly in water.  The generic EECs did not fully account for this route of rapid
dissipation.  EPA concludes that a level of concern for endangered species at the 8 Ib ai/A for
unincorporated and at 20 Ib ai/A for incorporated applications would not be triggered.

RQs for unincorporated applications at 20 Ibs ai/A exceed the LOC for effects to endangered fish.
The LOCs for restricted use and potentially high risk are not exceeded.  Incorporated applications
do not exceed any LOCs.

Long-term exposure levels (56-day average EECs) range from 3 to 67 ppb. Comparing these values
to the trout early life stage 56-day MATC of 330 ppb indicates  minimal likelihood of chronic risk to
fish.

The dichlobenil degradate BAM is practically non-toxic to aquatic organisms with a LC50 for bluegill
and trout at 120 and 140 ppm, respectively. BAM represents  minimal risk to fish.
                                             74

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                                   (b)    Freshwater Invertebrates

       Table 29: Aquatic Invertebrate Acute Risk Quotients for Granular Applications of
                     Dichlobenil, Both Unincorporated and Incorporated
Lbs
ai/A
2
4
6
8
20
Risk Quotients
Unincorporated
Initial
EEC
ppb
95
190
285
380
951
RQ
Oyster ECJO
1630 ppb
0.05
0.11*
0.17**
0.23**
0.58***
RQ
D. magna EC50
6200 ppb
0.01
0.03
0.04
0.06
0.15*
Incorporated
Initial
EEC
ppb
47
95
141
190
476
RQ
Oyster EC50
1630 ppb
0.02
0.06
0.09*
0.12*
0.29*
RQ
D. magna ECJO
6200 ppb
<0.01
0.01
0.02
0.03
0.08
       *      Exceeds Endangered Species LOG
       **      Exceeds Restricted Use LOC
       ***     Exceeds High Acute Risk LOC
Dichlobenil volatilizes rapidly in water.  Generic EECs do not fully account for this route of rapid
dissipation.  The Agency therefore concludes that a level of concern for endangered species of
freshwater aquatic invertebrates at the 8 Ib ai/A for unincorporated and at 20 Ib ai/A for incorporated
applications would not be triggered.   EPA also concludes that a level of concern for  endangered
species would not be triggered for mollusks from incorporated applications at 4 Ib ai/A and restricted
use would not be triggered for mollusks from unincorporated applications at 4 Ib ai/A.

Freshwater Mollusks
When a estuarine mollusk species (oyster) EC50 is available,  it is used as an indicator species for
freshwater mollusk species.

The LOC for potentially high acute risk to mollusks is exceeded for unincorporated applications at
20 Ib ai/A. The restricted use LOC is exceeded by unincorporated applications at 6 Ibs ai/A, and
incorporated applications at 20 Ibs ai/A. Unincorporated applications at 4 Ibs ai/A and higher and
incorporated applications at 6 Ibs ai/A and higher are considered to exceed the endangered mollusks
species LOC.

Aquatic Invertebrates
Unincorporated applications at  20 Ibs ai/A exceed the LOC for effects to  endangered aquatic
invertebrates.   The LOCs  for restricted use and potentially high acute risk are  not exceeded.
Incorporated applications do not exceed any LOCs.
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Long-term exposure levels (21-day average EECs) range from 9 to 180 ppb.  Comparing these values
to the Daphnia magna life cycle 21-day MATC of 750 ppb indicates minimal likelihood of chronic risk
to aquatic invertebrates.

The dichlobenil degradate BAM is practically non-toxic to aquatic organisms with an EC50 of 856
ppm for daphnids. BAM represents minimal risk to aquatic invertebrates.

                                   (c)     Estuarine and Marine Animals

Since the EC50 for shrimp (2.35 ppm) and oysters (1.63 ppm) are lower than that of freshwater
organisms (6.2 ppm for  daphnids), there  is a greater potential for risk for estuarine  organisms.
However, there are factors that may lessen this presumed risk.  The use sites that may result in
exposure to estuarine and marine environments are blueberries, apples, pears, cranberries and turf.
Based on data provided by registrants and other public sources, blueberry, apple and pear use sites
where dichlobenil is applied are not close to estuaries (Data from the National Center for Food and
Agriculture Policy) with the exception  of apples in Rhode Island and blueberries in Maine.
Dichlobenil used on apples and blueberries at these two locations could runoff into estuaries.  Minimal
exposure to estuaries from cranberry use sites are expected for the following reasons: flooding only
occurs at harvest time and levees hold any rainfall; application times are only early in the season or
at fall after harvest; and the granular formulation results in minimal drift to estuarine habitats. The
turf use sites are limited to spot treatment on grass lawns and to dichondra lawns which are limited
to the south eastern part of the U.S. Limited amounts of dichlobenil are used in this area.  Therefore,
dichlobenil is not generally expected to represent a high risk to estuarine and marine organisms except
from the use of apples in Rhode Island and blueberries in Maine.

There are no estuarine invertebrates or mollusks on the endangered species list.  However, there are
endangered estuarine fish species. Effects to endangered estuarine fish are not expected based on the
low toxicity (LC50=12,700 ppb) of dichlobenil to fish relative to exposure  potential.

                            (5)    Exposure and Risk to Nontarget Plants

                                   (a)     Terrestrial and Semi-aquatic

The Agency does  separate risk assessments for nontarget terrestrial and  semi-aquatic plants.
Nontarget terrestrial plants inhabit non-aquatic areas which are generally well drained. Nontarget
semi-aquatic plants inhabit low-lying areas that are usually wet, although they may be dry during
certain times of the year. Semi-aquatic plants are not obligatory aquatic plants in that they do not live
in a continuously aquatic environment.  Both the terrestrial and semi-aquatic plants are exposed to
pesticides from runoff.  They differ, however, in that terrestrial plants are assumed to be exposed via
sheet runoff, whereas semi-aquatic plants are assumed to be exposed  via channelized runoff.
Calculating runoff exposure is done using a simple model which assumes that a certain percentage
of that which is applied transports with run off.  The percentage is based on solubility.  Based on the
solubility of 25 ppm, it is assumed that approximately 2% of the applied dichlobenil runs off the site
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of application. Since dichlobenil is used as a granular at all use sites except for under the pavement
and sewer system treatment, drift is assumed to be negligible. Volatilization is also a potential route
of exposure to nontarget plants. However, vegetative vigor data are not available to determine risk
from this exposure.

The  EECs for terrestrial and semi-aquatic plants are calculated using the following formulae:

Unincorporated Application

         Terrestrial plants EEC (Ib ai/A) = appl rate (Ib ai/A) X 1 acre X  0.02 (percent runoff)

        Semi-aquatic plants EEC (Ib ai/A) = appl rate (Ib ai/A) X 10 acres X 0.02 (percent runoff)

Incorporated Application

Terrestrial plants EEC (Ib ai/A) = appl rate (Ib ai/A)  X  1 acre X 0.02 (percent runoff) -^ 5 cm depth

Semi-aquatic plants EEC (Ib ai/A) = appl rate (Ib ai/A) X 10 acres X 0.02 (percent runoff) -^ 5 cm depth


     Table 30 EECs and Risk Quotients for Terrestrial and Semi-aquatic Plants (Ec25=o.o23 ib ai/A)
Application Rate
(Ib ai/A)
2
4
6
8
20
Type of Plant
Terrestrial
Semi-aquatic
Terrestrial
Semi-aquatic
Terrestrial
Semi-aquatic
Terrestrial
Semi-aquatic
Terrestrial
Semi-aquatic
Incorporated Application
EEC (Ib ai/A)
0.01
0.08
0.02
0.16
0.02
0.24
0.03
0.32
0.08
0.80
Risk Quotient
EEC/EC25
<1
3.5
<1
7.0
<1
10.4
1.3
13.9
3.5
34.8
Unincorporated Application
EEC (Ib ai/A)
0.04
0.40
0.08
0.80
0.12
1.20
0.16
1.60
0.40
4.00
Risk
Quotient
EEC/EC25
1.7
17.4
3.5
34.8
5.2
52.2
7.0
69.6
17.4
173.9
Shaded area indicates that parameter exceeds LOG.
Table 30 above describes the risk quotients and EECs for terrestrial and semi-aquatic plants. The
LOG for potentially high risk for non-target semi-aquatic plants has been exceeded at all rates of
application.  The LOG for non-target terrestrial plants has been exceeded at 8 Ib ai/A or higher rates
                                              77

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when incorporated.  The LOG for potentially high risk for non-target terrestrial plants has been
exceeded at all rates of application when dichlobenil  is not incorporated.  At the higher rates, the
margins of exceedance are relatively high. It should be noted that the method of estimating exposure
did not fully take into account that during runoff events, dichlobenil moving with surface water will
likely volatilize relatively quickly, reducing potential exposure and impact.

Dichlobenil is also expected to affect endangered species of terrestrial and semi-aquatic plants.

                                   (b)    Aquatic

Exposure to non-target aquatic  plants may occur through runoff from  terrestrial sites or from
volatilization.  As with  terrestrial plants, exposure from volatilization cannot be estimated with
available data.  The  EECs are derived from the GENEEC program as described in  Table  25.
Duckweed, Lemna gibba, is used as the surrogate for aquatic vascular plants.  The diatom Navicula
pelliculosa is the most sensitive algae or diatom  species tested and is used to assess risk to algae and
diatoms.
             Table 31
EECs and Risk Quotients for Aquatic Plants
Application Rate
(Ib ai/A)
2
4
6
8
20
Type of Plant
Vascular (Lemna gibba)1
Algae and diatom2
Vascular
Algae and diatom
Vascular
Algae and diatom
Vascular
Algae and diatom
Vascular
Algae and diatom
Incorporated Application
EEC (ppb)
47
95
141
190
476
Risk
Quotient
EEC/EC50
2
<1
3
<1
5
<1
6
<1
16
<1
Shaded area indicates that parameter exceeds LOG.
Unincorporated Application
EEC (ppb)
95
190
285
380
951
Risk
Quotient
EEC/EC50
3
<1
6
<1
10
<1
13
<1
32
<1

              1 EC50 of 30 ppb is used for Lemna gibba.
              2 ECJO of 1,000 ppb is used for Navicula pelliculosa.

Table 31 above shows the risk quotients and EECs for aquatic plants. The LOG for diatoms and
algae is not exceeded. The LOG  for risk to non-target aquatic vascular plants from runoff has been
                                             78

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exceeded at all application rates. Even though soil incorporation reduces the aquatic EEC by about
one half, all use rates would still represent a risk to aquatic vascular plants including endangered
species of aquatic vascular plants.  Dichlobenil volatilizes rapidly in water. The generic EECs did not
fully account for this route of rapid dissipation.  The risk may not be as high as indicated in the tables.

                            (6)    Endangered Species

Dichlobenil may affect endangered species of birds, fish, aquatic invertebrates, freshwater mollusks
and plants.

When the Endangered Species Protection Program becomes final, limitations in the use of dichlobenil
may be required to protect endangered and threatened species, but these limitations have not been
defined and may be formulation specific. EPA anticipates that a  consultation with the Fish and
Wildlife Service may be conducted in accordance with the species-based priority approach described
in the Program. After completion of consultation, registrants will be informed if any required label
modifications are  necessary.  Such modifications would most  likely  consist of the  generic label
statement referring pesticide users to use limitations contained in county Bulletins.
              4.     Environmental Risk Characterization

                     a.     Overview of the Chemical

Dichlobenil is a non-selective herbicide registered for use on terrestrial food crops and non-food crops
including residential, industrial and agricultural non-crop sites. Dichlobenil is an inhibitor of cell wall
biosynthesis. Dichlobenil acts by thinning the cell wall which eventually causes cellular collapse of
the seedling.  It is  soil  applied and  is activated by moisture.  Formulations include the wettable
powder (used for sewage lines and under pavement) and the 4% granular.  Application rates range
from 2 Ib ai/A to 20 Ib  ai/A. Total dichlobenil use is estimated to be under 300,000 Ibs active
ingredients annually, with the largest acreage on cottonwood hybrids, cranberries, turf, apple and
cherry orchards, non-crop sites and ornamental. Most of dichlobenil is formulated as granulars. GIS
mapping interpretations were used to help assess areas impacted by dichlobenil use.

                     b.     Overview of the Findings

                            (1)    General  Conclusions  for  Environmental  Fate  and
                                   Transport

•      Dichlobenil dissipates in the environment (on soil  and in  surface water) principally by
       volatilization. However, it is  persistent under field conditions that reduce the potential  for
       volatilization (ie. cooler climates).  When transformation proceeds through aerobic soil
       metabolism, the metabolite, 2,6-dichlorobenzamide (BAM) is generated (13.1% at 50 weeks).
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       Under conditions where dichlobenil does not volatilize there is potential for both dichlobenil
       and BAM to move to ground water in coarse-textured soils low in organic matter.

•      Dichlobenil is  stable to hydrolysis, photodegradation in soil and  metabolic degradative
       processes. Dichlobenil is very persistent to aerobic soil metabolism (half-life of 46.3 weeks)
       and anaerobic aquatic metabolism (half-life of 2.8 years).

•      Terrestrial  field  dissipation  study results were consistent  with lab  study results with
       volatilization occurring more readily in warmer climates.

•      Both dichlobenil and BAM can be extremely mobile  and persistent under  anaerobic
       conditions.  Dichlobenil and BAM exceed levels of concern for ground-water quality.

•      Dichlobenil is predicted to volatilize from most surface waters; therefore, it's persistence in
       the surface water environment will depend primarily on the environmental factors which
       control volatility rates (temperature, wind speed, humidity, etc.).

Acceptable and supplemental  information from environmental fate studies with respect to  the
persistence and mobility of dichlobenil under laboratory and field conditions has been reviewed and
the environmental  data base for dichlobenil is essentially complete.

                            (2)    General Conclusions for Ecological Effects

Except for the acute effects to freshwater mollusks and non-target plants, the concentrations of
dichlobenil granules in the environment are not expected to cause either potentially high acute or
chronic levels of risk to non-target organisms.

Restricted use triggers  have been exceeded for birds and freshwater mollusks.

Endangered species of birds, mollusks, fish and plants may be affected from the use of dichlobenil.

                                   (a)    Acute Risk

The following exceedances have been identified from the risk assessment section of this document.
A qualitative discussion of risks to estuarine organisms is provided.
                                             80

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Table 32
Acute Risk Predicted with Dichlobenil1
Ibs ai/A
2
4
6
8
20
Terrestrial Animals
Birds2
E,
E, R
E, R
E, R, A
E, R, A, IE
Mammal
none
none
none
none
none
Freshwater Animals
Fish
none
none
none
none
E
Aquatic
Invertebrate
none
none
none
none
E
Mollusk
none
E
E, R,IE
E, R,IE
E, R, A, IE, IR
Plants
Aquatic
Plants
E, A, IE, IA
E, A, IE, IA
E, A, IE, IA
E, A, IE, IA
E, A, IE, IA
Terrestrial
Plants
E, A, IE, IA
E, A, IE, IA
E, A, IE, IA
E, A, IE, IA
E, A, IE, IA
     1 The codes in the table are as follows:
             - For unincorporated application: E= endangered species, R= restricted candidate, A= potentially high acute risk.
             - For incorporated application: IE= endangered species, IR= restricted candidate, IA= potentially high acute risk.

     2 It is estimated that there is minimal potential for adverse affects to birds from exposure to the smaller granules. The effects to birds are a
     result of exposure to the large size granules only.
      The 10G formulation poses a high potential for acute risk to birds at the 6 Ib ai/A or greater
      application rate when dichlobenil is not incorporated.

      Endangered species of birds may be affected by applications of the large 4G granules and 10G
      granules at all rates when unincorporated and at the 10 Ib ai/A or greater application rate
      when granules are incorporated.

      There is minimal likelihood of acute effects to mammals.

      At 20 Ibs ai/A, aquatic organisms are not at potentially high risk from dichlobenil except for
      freshwater mollusks.   As shown  on  the  table, endangered  fish  (20 Ib ai/A), aquatic
      invertebrates (20 Ib ia/A) and mollusks (4 Ibs ai/A or higher) may be affected.  The restricted
      use LOG is exceeded for freshwater mollusk (6 Ibs ai/A or higher).

      Exposure  to estuarine  invertebrates is expected to be minimal except from the uses of
      dichlobenil on apples in Rhode Island and blueberries  in Maine. Estuarine exposure from
      these use patterns is not known,  therefore, while estuarine invertebrates are more sensitive
      to dichlobenil than freshwater organisms, the risk is uncertain.

      Acute risk to honey bees is minimal.

      The degradate, BAM, poses minimal risk to aquatic and terrestrial organisms.

      Risks to non-target organisms from the wettable powder used for under the pavement and the
      sewage lines applications are considered to result in minimal exposure to the environment and
      therefore minimal risk to non-target organisms.
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Discussion of risk estimate for granular formulations and birds

In order to determine the risk to birds from granulars, the Agency used the method as described in
the "Comparative Analysis of Acute Avian Risk From Granular Pesticides" as published by the Office
of Pesticide Programs USEPA, March, 1992.

The following considerations were taken into account in assessing the acute risk to birds from the use
of dichlobenil:

•      Although birds are known to ingest pesticide granulars, the amount consumed is not known
       because the mechanisms of bird attraction, avoidance, and/or selection are not yet completely
       understood. The size  of granulars overlap, at least to some extent,  with the size of the grit
       the birds select (Best,  1992). "Characteristics of Corn Rootworm Insecticide Granules and
       the Grit Used by Cornfield Birds:  Evaluating Potential Avian Risks; Louis B Best Am. Midi.
       Nat. 128:126-138. 1992.

•      Only direct oral ingestion was considered for this assessment.  Birds  may also be exposed to
       granular pesticides through routes  other than direct oral ingestion of granulars; for example,
       drinking contaminated water after rainfall, preening contaminated feathers, contacting eyes
       with contaminated water while bathing, walking on contaminated soil and breathing fumes
       of dichlobenil.  Consideration of additive exposures would result in higher risk than had been
       predicted in this analysis.

•      The length of time the granular remains intact in a size that can be consumed by birds as grit
       is unknown.

The Agency considered dichlobenil in the report, Comparative Analysis of Acute Avian Risk From
Granular Pesticides. (OPP/USEPA, 1992) Dichlobenil was  not included in the comparative analysis
because it was not highly toxic to birds.

                                  (b)     Chronic Risk

•      Chronic risk to birds  can not be assessed due to lack of avian reproduction data. These
       studies are requested.

•      There is minimal likelihood of chronic effects to mammals.

•      There is minimal likelihood of chronic effects to fish  and aquatic invertebrates

•      The BAM degradate poses minimal chronic risk to aquatic and terrestrial organisms because
       exposure is unlikely to occur to aquatic organisms  at levels that exceed the LOG.
                                            82

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                            (3)    General Conclusions for Ground Water Quality

OPP  is concerned about the potential degradation of ground-water quality that may occur in
dichlobenil use areas. The mobility of dichlobenil is correlated with organic matter content of the
soils.  Dichlobenil is very mobile in low organic matter soils.  The principal degradate BAM, is more
mobile than its parent. It is likely that use of dichlobenil on low organic matter soils will result in
leaching through the soils and may reach ground-water.  Both dichlobenil and BAM are extremely
mobile and persistent under anaerobic conditions.

Dichlobenil and its degradates exceed levels of concern for Ground-Water Quality. Dichlobenil
exceeded all the triggers for mobility and persistence used to recommend restricted use, but not the
ground-water detection trigger at this time.

With only one well sampled for dichlobenil in the United States to date, there has been extremely
limited monitoring for dichlobenil and BAM in ground-water. (Hoheisel,  et al.,  1992). Information
provided  by the registrant demonstrates that dichlobenil can  leach to  ground-water in some
environments.  Residues of dichlobenil and BAM were reported in  surface and ground-water studies
in Europe.
IV.    RISK MANAGEMENT AND REREGISTRATION DECISION

       A.     Determination of Eligibility

Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant data
concerning an active ingredient, whether products containing the active ingredients are eligible for
reregistration. The Agency has previously identified and required the submission of the generic (i.e.,
active ingredient specific) data required to support reregistration of products containing dichlobenil
active ingredients. The Agency has completed its review of these generic data, and has determined
that the data are sufficient to support reregistration of most products containing dichlobenil under the
conditions specified in this Reregistration Eligibility Document (RED).  A decision on the eligibility
of products applied to sewers or applied with a granular backpack can not be made at this time.
Appendix B  identifies the generic data requirements that  the  Agency reviewed as part of its
determination of reregistration eligibility of dichlobenil, and lists the submitted studies that the Agency
found acceptable.

The Agency therefore finds that all products containing dichlobenil as the active ingredients  are
eligible for reregistration under the conditions specified in this RED except for those registered for
application to sewers or granular backpack application.  The reregistration of particular products is
addressed in Section V of this document.

The Agency made its reregistration eligibility determination based upon the target data base required
for reregistration, the current guidelines for conducting acceptable studies to generate such data,
                                             83

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published scientific literature, etc. and the data identified in Appendix B. Although the Agency has
found that most uses of dichlobenil identified in Appendix A are eligible for reregi strati on under the
conditions specified in this RED, it should  be  understood that the Agency may take additional
appropriate regulatory  action,  and/or  require the submission of additional data to support the
registration of products containing dichlobenil, if new information comes to the Agency's attention
or if the data requirements for registration (or the guidelines for generating such data) change.

       B.     Determination of Eligibility  Decision

              1.     Eligibility Decision

Based on the reviews of the generic data for the active ingredients dichlobenil, the Agency has
sufficient information on the health effects of dichlobenil and on its potential for causing adverse
effects in fish and wildlife and the environment.  The Agency has determined that dichlobenil
products, labeled and used as  specified in this  Reregi strati on Eligibility Decision, will  not pose
unreasonable risks or adverse effects to humans or the environment with the exception of sewer and
granular backpack application use sites.  Therefore, the Agency concludes that products containing
dichlobenil for the remaining uses are eligible for reregi strati on under the conditions specified in this
RED.

              2.     Eligible and Ineligible Uses

The Agency has determined that all uses except sewer treatment and granular backpack application
of dichlobenil are eligible  for reregi strati on provided application rates  are modified and other
precautions as noted in this RED are followed. The Agency can not make a decision at this time as
to the eligibility of sewer treatment and granular backpack application of dichlobenil usage sites at
this time because additional data are needed to evaluate exposure of mixer/loader/applicators at these
sites.

       C.     Regulatory Position

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

              1.     Food Quality Protection Act Findings

Determination of safety includes consideration  of special sensitivity to children, potential cumulative
effects with pesticides that have a common  mode of toxicity,  and aggregate risks resulting from
exposure to dietary residues, drinking water,  and residential sources.

Although the available toxicological database for dichlobenil appears to suggest a sensitivity for
infants and children to dichlobenil, the Agency  has determined that there  is no need for an additional
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safety  factor. This  decision  is  based on findings  of the two generation reproduction and
developmental toxicity studies. These studies indicate that there is no evidence of increased sensitivity
of the test animals to prenatal exposure to dichlobenil.  The NOELs for developmental effects are
equal to or greater than the NOELs for maternal effects, thus not indicating a unique sensitivity for
prenatal exposure. A lower NOEL in offspring than adults in the two generation reproduction data
appeared to suggest an increase in offspring sensitivity. In that study, it was noted that low pup birth
weights were only in  the first generation, not the second generation.  Thus, the effect is  not
reproducible. It was concluded that only minimal confidence could be placed in the pup body weight
data that appeared to suggest an increase in sensitivity to the offspring of rats following postnatal
exposure to dichlobenil.

For BAM there does not appear to be any unique sensitivity from prenatal exposure. However, as
previously stated, the BAM toxicological database is incomplete.  However, dietary risk estimates
utilizing the BAM reference dose (which was calculated using an additional 3X factor to  account for
the incomplete database) should sufficiently account for any special sensitivities of infants or children
that are unknown due to the lack of a rat developmental study and the unacceptable reproductive
study.

It is also noted that there is no post-natal dietary (food source) exposure to dichlobenil, and possible
exposure in drinking water is not considered to be a major route of exposure.

 The use of an uncertainty factor of 100 (10X for interspecies variability, and 10X for intraspecies
variability) in the risk assessment for dichlobenil provides adequate protection  of infants and children.
The Agency has determined that insufficient data are available to conclude that other pesticides either
have or do not have a common mode of toxicity with dichlobenil.

An aggregate risk assessment resulting from combining exposures from residential uses of dichlobenil
with exposures from drinking water consumption could be performed. When comparing exposures
from  the  homeowner application scenarios and adult  consumption of dichlobenil contaminated
drinking water, the exposure value for consumption of drinking water is orders of magnitude lower
than that of a homeowner applicator.  Therefore, the risk is essentially that of residential exposure
alone  since the contribution from drinking water is insignificant in comparison. Note that the Agency
has no information to indicate that this type of exposure is likely to occur.

There are no chronic homeowner exposure scenarios; therefore, the aggregate chronic risk would
include only dietary exposure from  consumption  of  the BAM  metabolite  and  drinking  water
contributions. Although there are insufficient data to estimate chronic drinking water exposure for
BAM, a combined food source and drinking water assessment cannot be performed. Since the toxicity
endpoints for use in chronic risk assessment are different for dichlobenil and BAM, aggregation of
risks would be appropriate only for residues of BAM from food and drinking water. The most highly
exposed subpopulation from food containing residues of BAM was estimated to utilize 20 percent
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of the RfD. Consequently the drinking water risk from BAM could be as high as 80 percent of the
RfD and still be protective of the public health. Monitoring data for both dichlobenil and BAM
residues in drinking water are required to confirm the Agency's conclusion that the public health is
protected.

              2.      Endocrine Disrupter Effects

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

              3.      Tolerance Reassessment

Tolerances Listed Under 40 CFR SI80.231:

The tolerances listed under 40  CFR §180.231 are for the combined negligible residues of the
herbicide dichlobenil (2,6-dichlorobenzonitrile) and its metabolite 2,6-dichlorobenzoic acid (2,6-
DCBA).    The  FIED   Metabolism  Committee   has  determined  that   the  metabolite  2,6-
Dichlorobenzamide (BAM) should be added to the tolerance expression and the metabolite 2,6-
DCBA should be deleted from the tolerance expression.  Therefore, 40 CFR §180.231 should be
modified to state: "Tolerances are established for the combined residues of the herbicide dichlobenil
(2,6-dichlorobenzonitrile) and its metabolite 2,6-dichlorobenzamide in  or on the following raw
agricultural commodities: ..."

Sufficient data are available to ascertain the adequacy of the established tolerances listed in 40 CFR
§180.231 for the following commodities: apples, blackberries, blueberries, cranberries, filberts, pears,
and raspberries.

The available data indicate that the  established tolerances for apples and pears are too low and that
increased tolerances are necessary.  The available data also indicate that the  established tolerances
for blackberries, cranberries, and raspberries are too high and that tolerances of 0.1 ppm would be
more appropriate.  A separate tolerance for filberts will be proposed at 0.1 ppm.

Additional field residue  data are  required for grapes before a complete tolerance reassessment can
be made.  Processing studies for apples and grapes remain  outstanding.  Following receipt of the
requested data on animal  metabolism, and the magnitude of residues, the need for and expression of
tolerances for residues in animal commodities will be determined.
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Table 33: Tolerance Reassessment Summary
Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comment/Correct Commodity Definition
Tolerances listed under 40 CFR §180.231
Almond hulls
Apples
Avocados
Blackberries
Blueberries
Citrus
Cranberries
Figs
Grapes
Mangoes
Nuts
Pears
0.15
0.15
0.15
0.15
0.15
0.15
0.15
0.15
0.15
0.15
0.15
0.15
Revoke
0.5
Revoke
0.1
0.15
Revoke
0.1
Revoke
TBD1
Revoke
Revoke
0.5
The tolerance should be revoked because no
registered uses exist for almonds.
The available data indicate that the established
tolerance is too low, due to the addition of the
BAM metabolite to the tolerance expression.
These data indicate the need to increase the
tolerance for the combined residues of dichlobenil
and BAM.
The tolerance should be revoked because no
registered uses exist for avocados.
The available data indicate that the established
tolerance is too high and that the tolerance for the
combined residues of dichlobenil and BAM can be
decreased.

The tolerance should be revoked because no
registered uses exist for citrus.
The available data indicate that the established
tolerance is too high and that the tolerance for the
combined residues of dichlobenil and BAM can be
decreased.
The tolerance should be revoked because no
registered uses exist for figs.
Adequate BAM data have been submitted,
however data for residues of dichlobenil remain
outstanding.
The tolerance should be revoked because no
registered uses exist for mangoes.
The established nuts tolerance should be revoked
concomitant with the establishment of a separate
tolerance for filberts since the use of dichlobenil
on all other nuts has been cancelled.
Residue data were translated from apples. The
available data indicate that the established
tolerance is too low, due to the addition of the
BAM metabolite to the tolerance expression.
These data indicate the need to increase the
tolerance for the combined residues of dichlobenil
and BAM.
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Commodity
Raspberries
Stone fruits
Current Tolerance
(ppm)
0.15
0.15
Tolerance
Reassessment (ppm)
0.1
Revoke
Comment/Correct Commodity Definition
Residue data were translated from blackberries.
The available data indicate that the established
tolerance is too high and that the tolerance for the
combined residues of dichlobenil and BAM can be
decreased.
The established stone fruit tolerance should be
revoked concomitant with the establishment of a
separate tolerance for cherries, since the use of
dichlobenil on all other stone fruits has been
dropped.
Tolerances to be established under 40 CFR §180.231
Cherries
Filberts
(0. 1 5- stone fruits)
(0.15 -nuts)
TBD1
0.1
A separate tolerance should be established for
cherries since other stone fruit uses are not being
supported. A value of 0. 1 5 should be used for
residues of dichlobenil and BAM in/on sweet and
sour cherries until the new residue data
submissions are evaluated by the Agency.
A separate tolerance should be established for
filberts since no other tree nut uses are being
supported by Uniroyal Chemical.
       TBD = To be determined. Reassessment of tolerance(s) cannot be determined at this time because additional data
       are required.
CODEX HARMONIZATION

No Codex MRLs have been established for residues of dichlobenil. Therefore, there are no questions
with respect to compatibility of U.S. tolerances with Codex MRLs.

              4.     Tolerance Revocations and Import Tolerances

During EPA's process of preparing the reregi strati on eligibility document for dichlobenil several
food/feed uses were voluntarily cancelled. Once a pesticide use is no longer registered in the United
States, the related pesticide residue tolerance generally is no longer needed.  It is EPA's policy to
propose revocation of a tolerance, following the deletion of a related food use from a registration,
or following the cancellation of a related food-use registration.  EPA has the responsibility under the
Federal Food, Drug, and Cosmetic Act (FFDCA) to revoke  a tolerance on the  grounds that the
Agency cannot conclude that the tolerance is protective of the public health.

The Agency recognizes, however, that interested parties may want to retain a tolerance in the absence
of a U.S. registration, to allow legal importation  of food into the U.S.  To assure that all food
marketed in the U.S. is safe, under FFDCA, EPA requires the  same technical chemistry and
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toxicology data for such import tolerances (tolerances without related U.S. registrations) as are
required to support U.S. food use registrations and any resulting tolerances. See 40 CFR Part 158
for EPA's data requirements to support domestic use  of a pesticide and  establishment and
maintenance of a tolerance. In addition, EPA requires residue chemistry data (crop field trials) that
are representative of growing conditions in exporting countries in the same manner that EPA requires
representative residue  chemistry data from different U.S. regions to support domestic use of the
pesticide and the tolerance.  Additional guidance on the Agency's import tolerance policy will be
published in an upcoming Federal Register Notice.

Parties interested in supporting an existing dichlobenil tolerance as an import tolerance should ensure
that all of the data noted above are available to EPA during its further assessments of existing
tolerances, so that the Agency may  determine  whether maintenance of the tolerance would be
protective of the public health.

                     a.      Human Health

                            (1)    Dietary

Acute Dietary

The Agency has not evaluated the acute (1 day) dietary (food source) risk associated with the use of
dichlobenil because a scenario in which consumption of dichlobenil per se residues occurred was not
identified. BAM is the major residue detected in food/feed items treated with dichlobenil. However,
an acute drinking water risk assessment for consumption of dichlobenil was performed.  The level of
concern was not exceeded.

Although a scenario for consumption of BAM exists, no acute assessment was  performed because
no endpoint of concern for use in this assessment was identified. The endpoints observed in the BAM
developmental study  were inappropriate for an acute dietary assessment.

Chronic Dietary

Dichlobenil was classified as a nonquantifiable group C (possible human) carcinogen, therefore the
RfD approach was used  to evaluate chronic dietary risk.  The Agency has evaluated the chronic
dietary risk associated with the consumption of the dichlobenil metabolite BAM based on tolerance
level residues, 100%  crop treated data and estimated BAM residue values for meat and milk.  The
RfD for BAM was determined to be 0.015 mg/kg/day based upon the NOEL from a chronic toxicity
study in dogs and an uncertainty factor of 300 (100 x 3).  The uncertainty factor of 100  accounts for
the inter-species extrapolation and intra-species variability.  The uncertainty factor of 3 is to
compensate for the lack of an acceptable BAM  reproduction study.  The highest chronic dietary
exposure, for non-nursing infants <  1 year, was 20% of the RfD. Most of the sub-group exposures
were less than 7%.
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A chronic drinking water risk was assessed for dichlobenil. The RfD for dichlobenil was determined
to be 0.013 mg/kg/day based upon a NOEL of 1.25 mg/kg/day from a two-year dog feeding study
and an uncertainty factor of 100. The chronic dietary exposure of non-nursing infants (< 1 year) to
dichlobenil from drinking water was 26%  of the RfD.  While the dietary exposure to the general
population was 10% of the RfD.  The Agency  considers exposures which utilize 100% or less of the
RfD to be adequately protective.

                            (2)     Occupational and Residential
Short-Term (1-1 days)
The Agency has determined that there is a potential for dermal and inhalation exposure to pesticide
handlers. The endpoint used for the short-term assessment is a developmental toxicity study based
on a NOEL of 45 mg/kg/day. The  MOEs for short-term occupational exposure resulting in
subchronic systemic effects to dichlobenil  are greater than 100 for  all the  exposure scenarios
considered.  PPE as specified in the description of the exposure scenarios, long-sleeved shirt, long
pants, shoes, socks and chemical resistant gloves for mixers and loaders; long-sleeved shirt, long
pants, shoes, socks and no gloves for applicators, will be required.

Intermediate (1 week to several months)
The usage data available to the Agency do not support either intermediate-term or chronic exposure
for most scenarios.  However available information indicate that exposure based on sewer use can
be considered  an  intermediate scenario.  However, there are  no exposure data to perform an
assessment.  Therefore, exposure  data will be required  for sites  identified as having potential
intermediate exposure: granular backpack application and application to sewer pipes.  The NOEL (3
mg/kg/day) that will be used in the intermediate-term assessment is from a 2-generation reproduction
study.

Post-Application
There are no data available to  address post-application exposures to  dichlobenil for persons re-
entering areas treated with dichlobenil.  For most scenarios, the potential for dermal exposure
following applications of dichlobenil appears to be limited since dichlobenil applications are made to
the soil early in the season and may be followed by shallow incorporation or irrigation. Generally if
the MOEs at the time of application are greater than 100, then post-application MOEs should be even
larger.

However, there are concerns about the use of dichlobenil in some horticultural/nursery scenarios.
Therefore, post-application exposure  studies for applications of  dichlobenil to ornamentals are
required.

A 12-hour restricted-entry interval (REI) for all uses of dichlobenil except horticultural/nursery uses
within the scope of the WPS was established.
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A 24-hour restricted-entry interval for all horticultural/nursery uses of dichlobenil within the scope
of the Worker Protection Standard for Agricultural Pesticides (WPS) was established due to concerns
about inhalation exposure of nursery workers to dichlobenil vapors, as well as, the uncertainties for
exposure to the soil metabolite BAM.  As previously stated, the toxicological database for BAM is
not as complete as that for dichlobenil. If the dichlobenil is not incorporated (physically or by
watering in), then due to dichlobenil's moderate vapor pressure there is the potential for vaporization
at ambient temperatures.  The 24-hour REI would allow time for the dispersement of dichlobenil
vapors generated by vaporization.  During the 24 hours the dichlobenil should be activated by soil
moisture, thus enabling the dichlobenil to "flow" to the subsurface. Once the application has been
correctly  incorporated through watering-in and the treated surface is dry, workers may enter the
treated area during the REI without PPE if they are performing tasks that do not involve contact with
the soil subsurface. Thus, the 24 hour REI can be  effectively shortened by watering in.

Due to concerns about inhalation exposures from sewer treatments, ventilation (open window or
exhaust fan) must be supplied for all treatment uses in connection with inhabited buildings, such as
residences, offices, and hospitals. This measure should adequately prevent inhalation exposure to
occupants of buildings where the sewer lines are being treated because only  a small amount of
dichlobenil is used in sewer treatment and plumbing systems have water traps that trap gas to prevent
its entry into buildings.

                     b.     Environmental

The exposure estimates (EECs) used for assessing the ecological risks to wildlife were produced with
a GENEEC model. The model does not account for the dissipation of dichlobenil by volatilization,
so the risks in  some instances may be significantly  less.
                            (1)     Avian

Acute
The overall acute risk to birds is low. However, the acute risk for birds from different dichlobenil
granule formulations vary with granule size and concentration of dichlobenil per granule.  The 4G
formulation (both 16/30 and 8/30 granule size) is not expected to pose a potential for acute risk. The
10G formulation poses a potential for acute risk to birds at the 6 Ib. ai/A or greater application rate
when dichlobenil is not incorporated.  Due to these risk estimates, the registrant has agreed to lower
the maximum application rate from 20 Ib ai/A to  10 Ib ai/A. Further the Agency is requiring that the
label for the 10G formulation impose soil incorporation. The small granules (16/30 size) of the 4G
formulation are not expected to have an acute effect to endangered birds.  Endangered species of
birds may be  affected by  applications of the  larger 4G and 10G dichlobenil granules  at  all
unincorporated rates and at the 10 Ib ai/A or higher incorporated rates.  The Agency is developing
a program to mitigate risks to endangered species. Dichlobenil will be included in that program.
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Chronic
Chronic  risk can not be assessed due to lack of avian reproduction studies.  These studies are
required.

                           (2)    Mammals

Acute
No levels of concern were exceeded. There is minimal likelihood of acute effects to mammals.

Chronic
The likelihood of chronic effects to mammals is minimal since they do not intentionally ingest clay
granules  or soil.

                           (3)    Insects

Dichlobenil is practically non-toxic to honeybees. Therefore, insects are not likely to be adversely
affected by the use of dichlobenil.

                           (4)    Freshwater Fish

The acute LOC for unincorporated application of dichlobenil at a 20 Ib ai/A rate exceed the LOC for
effects to endangered fish. However the chronic risk to fish was determined to be minimal.

                           (5)    Aquatic invertebrates

The LOC for potentially high acute risk to mollusks is exceeded for unincorporated applications at
20 Ib ai/A. The restricted use LOC is exceeded by unincorporated applications at or above 6 Ibs ai/A,
and incorporated applications at 20 Ibs ai/A. Unincorporated applications at or above 4 Ibs ai/A and
incorporated applications at or above 6 Ibs ai/A exceed the endangered mollusks species LOC.

Unincorporated  applications at 20 Ibs ai/A exceed the LOC for effects  to endangered aquatic
invertebrates.  The LOCs for restricted use and  potentially high acute risk  are not exceeded.
Incorporated applications do not exceed any LOCs.

                           (6)    Estuarine and Marine Organisms

Exposure to estuarine invertebrates is expected to be minimal except from the uses of dichlobenil on
apples in  Rhode Island and blueberries in Maine.  Estuarine exposure from these use patterns is not
known; therefore, while estuarine invertebrates are more sensitive to dichlobenil than freshwater
organisms, the risk is uncertain.
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                            (7)     Nontarget Plants (Terrestrial, Semi-Aquatic, and Aquatic)

The Agency has evaluated data which indicate that high acute risk LOCs are exceeded for all vascular
terrestrial, semi-aquatic, and aquatic plants at application rates as low as 2 Ibs ai/A.   Therefore, use
of dichlobenil on all sites may adversely affect nontarget terrestrial and semi-aquatic plants, including
endangered species.  This evaluation does not take into account the dissipation of dichlobenil from
volatilization, so the risk may be significantly less.

                            (8)     Forestry

The registration of hybrid cottonwood-poplar plantation use has recently expanded under section 3
of FIFRA to regions beyond the Oregon- Washington desert sites evaluated. Use of dichlobenil at
hybrid cottonwood-poplar plantation sites in the eastern Oregon-Washington desert region which is
defined as 15  miles from the Columbia river in the counties of Walla Walla, Franklin and Benton in
Washington and Umatilla and Morrow in Oregon was not considered a forestry use. The Agency
does not have sufficient forestry dissipation data to evaluate use of dichlobenil at hybrid cottonwood-
poplar hybrid sites beyond the evaluated area.

                            (9)     Endangered Species

The Agency has concerns about the exposure of threatened and endangered plant, bird, and mollusk
species to dichlobenil as discussed above in the Section III. Currently, the Agency is developing a
program ("The Endangered Species Protection Program") to identify all pesticides whose use may
cause adverse impacts on endangered and threatened species and to implement mitigation measures
that will eliminate the adverse impacts. The program would require use modifications or a generic
product label statement, requiring users to consult county-specific bulletins. These bulletins would
provide information about specific use limitations to protect endangered and threatened species in the
county.  Consultations with  the Fish and Wildlife  Service may be necessary to assess risks to newly
listed species or from existing or proposed new uses.

The Agency plans to publish a description of the Endangered Species Program in the Federal Register
in the future. Because the Agency is taking this approach for protecting endangered and threatened
species, it is not imposing label modifications at this time through the RED. Rather, any requirements
for product use modifications will occur in the  future under the  Endangered  Species Protection
Program.

                            (10)    Surface Water

Although dichlobenil has the potential to contaminate surface water from  run-off and spray drift,
limited surface water monitoring information is  available at this time.  There is not a significant
concern for dichlobenil contaminating surface water because dichlobenil  has a high potential  to
volatilize from surface waters.
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There is insufficient data to determine the potential of the BAM metabolite to contaminate surface
water.  Data on the vapor pressure and solubility of BAM are required in order to calculate Henry's
constant and model BAM's fate in surface water.  Additional environmental fate studies on BAM may
be required to determine its potential to contaminate surface water, if the Henry's constant for BAM
is less than 10"5. If Henry's constant is less than 10"5, it indicates that BAM does not volatilize from
surface water, and aerobic soil metabolism, aerobic aquatic  metabolism, adsoption/desorption and
photodegredation in water studies are required on BAM.

                            (11)   Ground Water

Dichlobenil and its metabolite BAM exhibit some of the properties and characteristics of chemicals
that have been detected in ground water.  Environmental fate data suggest that dichlobenil and BAM
leach to ground water as a result of normal agricultural use.

To date, there has been extremely limited monitoring for dichlobenil and BAM in ground water in the
United States with one well sampled for dichlobenil. (Hoheisel,  et al., 1992). Information provided
by the registrant demonstrates that dichlobenil can leach to ground water in some environments.
Residues of dichlobenil and BAM were reported in surface and ground water studies in Europe.

Uniroyal, the basic producer has already placed a ground water advisory on product labels. All
dichlobenil product labels must bear the ground water advisory presented in chapter V.

Because OPP's ground water concerns are focused on  the potential occurrence of BAM in drinking
water and the resulting possible human exposure, OPP is requiring a drinking water monitoring study.
The drinking water study results will be used to determine if any additional ground water mitigation
measures or additional prospective ground water studies are needed.

A  small scale prospective ground water study is being required at this time only to support hybrid
cottonwood poplar sites outside the desert areas of the pacific northwest defined as 15 miles from
the Columbia river in the counties of Walla Walla, Franklin and Benton in Washington and Umatilla
and Morrow in Oregon. These data are needed because of the potential for the expansion of the use
of dichlobenil for hybrid cottonwood poplar tree to areas vulnerable to ground water contamination.

A small scale prospective ground water study was not required at other sites based on the available
dichlobenil usage information which indicate annual production of dichlobenil is less than 300,000
Ibs.  If the use of dichlobenil for cottonwood-poplar pulpwood production is expanded to areas
considered vulnerable, one or more small-scale prospective ground water studies would need to be
conducted. An alternative to generating this data for a small scale prospective ground water study
for hybrid cottonwood sites is for the registrant(s)  to limit to the use of dichlobenil at  hybrid
cottonwood poplar production sites to desert areas of the Pacific northwest which is defined as 15
miles from the Columbia river in the counties of Walla Walla, Franklin and Benton in Washington and
Umatilla and Morrow in Oregon.
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              5.      Restricted Use Classification

Dichlobenil is not classified as restricted use. However, many dichlobenil products for treating sewers
contain metam sodium and are therefore classified as restricted use.

              6.      Endangered Species Statement

Currently, the Agency is developing a program ("The Endangered Species Protection Program") to
identify all  pesticides whose use may  cause adverse impacts on endangered and threatened species
and to implement mitigation measures that will eliminate the adverse impacts.  The program would
require use  restrictions  to  protect  endangered and threatened  species  at the county  level.
Consultations with the Fish and Wildlife Service may be necessary to assess risks to newly listed
species or from proposed new uses. In the future, the Agency plans to publish a description  of the
Endangered Species Program in the Federal Register and have available voluntary county-specific
bulletins. Because the Agency is taking this approach for protecting endangered and threatened
species, it is not imposing label modifications at this time in the RED. Rather, any requirements for
product use modifications will occur in the future under the Endangered Species Protection Program.

              7.      Occupational/Residential Labeling Rationale

Even though data to address post-application exposure are not available, there are several post-
application exposure scenarios, involving both dermal and inhalation exposures, for which some risk-
mitigation measures are prudent.

Due to concerns about inhalation exposure from vaporization of dichlobenil in enclosed areas, soon
after  application,   the  Agency  is  establishing a  24-hour  restricted-entry  interval  for   all
horticultural/nursery uses of dichlobenil within  the scope of the Worker Protection Standard for
Agricultural Pesticides (WPS).   These uses include  uses on woody agricultural (orchards and
bramble) and ornamental (shrubs  and  trees) crops and the  Special  Local Need  (SLN) use  on
dichondra.  Due to the inhalation (off-gassing) exposure concerns, the Agency is requiring that the
application be thoroughly incorporated into the  soil (or other target surface) through watering-in.
The Agency notes that once the product has been correctly incorporated through watering-in and the
treated surface is dry, the WPS permits workers to enter the treated area during the restricted-entry
interval without personal protective equipment or any other restriction  if they are performing tasks
that do not  involve contact with the soil subsurface.

Due to concerns about dermal and inhalation exposures from soil and soil-subsurface contact soon
after application, the  Agency recommends  thorough incorporation through watering-in for  all
products primarily  intended for homeowner use.  Entry would be restricted until the soil  is  dry
following the watering-in.
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Due to concerns about inhalation exposures from sewer treatments, EPA is establishing a requirement
for all uses in connection with inhabited buildings (residences, offices, hospitals, etc.) specifying that
windows must be open or an exhaust fan must be operating during the application.

Scope of the Worker Protection Standard (WPS)

The 1992 Worker Protection  Standard for Agriculture Pesticides (WPS) established certain worker-
protection requirements (personal protective equipment, restricted entry intervals, etc.) to be specified
on the label of all products that contain uses within the scope of the WPS. Uses within the scope of
the WPS include all commercial (non-homeowner) and research uses on farms, forests, nurseries, and
greenhouses to produce agricultural plants (including food, feed, and fiber plants, trees, turf grass,
flowers, shrubs, ornamentals,  and seedlings).  Uses within the scope include not only uses on plants,
but also uses to the soil or planting medium the plants are (or will be) grown in.

Some of the registered uses  of dichlobenil are within the scope of the Worker Protection Standard
and some uses are outside the  scope of the WPS.  Those that are outside the scope of the WPS
include use:

•      on plants that are in ornamental gardens, parks, golf courses, and public or private lawns and
       grounds and that are  intended only for decorative or environmental benefit;

•      in a manner not directly  related to the production of agricultural plants,  including,  for
       example, control of vegetation along rights-of-way, in hedgerows  and fencerows and in other
       non-crop areas, sewer treatments, and treatments under asphalt and  swimming pool liners.

                     a.     Personal   Protective   Equipment/Engineering   Controls   for
                            Handlers for Occupational-Use Products (WPS and NonWPS
                            Uses)

The PPE requirements will  pertain to both  the WPS and nonWPS uses by occupational handlers,
since the potential exposure to occupational handlers is similar for WPS and nonWPS uses.

For each occupational end-use product, PPE requirements for  pesticide handlers will be set during
reregi strati on in one of two ways:

       1. If EPA determines that no regulatory action must be taken as a result of the acute or other
       adverse effects of an active ingredient, the PPE for pesticide handlers will be based on the
       acute toxicity of the end-use product.  For occupational-use products, PPE will be established
       using the process described in PR Notice 93-7 or more recent EPA guidelines.

       2. If EPA determines that regulatory action on an active ingredient must be taken as the result
       of very high acute toxicity or to certain other adverse effects,  such as allergic effects or
       delayed effects (cancer,  developmental toxicity, reproductive effects, etc):
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•      In the RED for that active ingredient, EPA may establish minimum or "baseline handler PPE
       requirements that pertain to all or most occupational end-use products containing that active
       ingredient."

•      These minimum PPE requirements must be compared with the PPE that would be designated
       on the basis of the acute toxicity of each end-use product.

                           (1)    Wettable Powder Formulations

For the wettable powder formulations, the MOEs for short-term exposures were calculated as being
acceptable for mixers and loaders when chemical resistant gloves were worn with long-sleeve shirts,
long pants, shoes, and socks. Therefore, such clothing and PPE will be required for persons mixing
and loading WP formulations.  Because acceptable MOEs were calculated for groundboom
applicators (pre-asphalt use) wearing long-sleeve shirts and long pants, shoes, and socks, but no
gloves, no minimum (baseline) PPE will be established for such handlers. For the sewer uses however,
a requirement for chemical-resistant gloves is being established for applicators and other handlers (in
addition to mixers and loaders) based on the uncertainties regarding the potential exposure of the use.
For the sewer use, dichlobenil is often used with metam sodium.  Since the PPE requirements for
metam sodium are likely to be more stringent than for dichlobenil, the metam sodium requirements
will be retained.

                           (2)    Granular Formulations

For the granular formulations, the MOEs for short-term occupational exposures were calculated
as being acceptable for mixers and loaders when wearing chemical-resistant gloves, long-sleeve shirts,
long pants, shoes, and socks. Therefore, such clothing and PPE will be required for persons mixing
and loading granular formulations.  Since the MOEs for short-term occupational exposure  for
applicators of the granular formulations are greater than 100 when wearing long-sleeved shirt, long
pants, shoes, socks, and no gloves, no minimum (baseline) PPE will be established for  such handlers.
The PPE for these handlers can be set on the toxicity of the end-use product.

                     b.     PPE/ Engineering Controls for Homeowner-Use Products

The MOEs for products intended primarily for homeowner use were calculated as being acceptable
for mixing, loading, and applying without assuming any specific clothing or equipment being worn.
Therefore,  no minimum (baseline) clothing or equipment  requirements  are  being  established.
However, directions specifying ventilation during application are being required for  homeowner
products for use as a sewer treatment.  This is based on dichlobenil's moderate vapor pressure.
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                     c.     Post-Application/Entry Restrictions

                            (1)    Occupational-Use Products (WPS Uses)

Restricted-Entry Interval: Under the Worker Protection Standard (WPS), interim restricted entry
intervals (REI) for all uses within the scope of the WPS are established on the basis of the acute
toxicity of the active ingredient.  The toxicity categories of the active ingredient for acute dermal
toxicity, eye irritation potential, and skin irritation potential are used to determine the interim WPS
REI. If one or more of the three acute toxicity effects are in toxicity category I, the interim WPS REI
is established at 48 hours. If none of the acute toxicity effects are in category I, but one or more of
the three is classified as category II, the interim WPS REI is established at 24 hours. If none of the
three acute toxicity effects are in category I or II, the interim WPS RED is established at 12 hours.
A 48 hour REI is increased to 72 hours when an organophosphate pesticide is applied outdoors in
arid areas.  In addition, the WPS specifically retains two types of REIs established by the Agency
prior to the promulgation of the WPS: product-specific REIs established on the basis of adequate data
and interim REIs that are longer than those that would be established under the WPS.

For occupational end-use products containing dichlobenil  as an  active ingredient, the Agency is
setting a restricted-entry interval at 24 hours for all horticultural/nursery uses of the product that is
within the scope of the Worker Protection Standard (WPS). In addition, due to dermal and inhalation
concerns, as well as the uncertainties of whether the use-scenarios should be considered to be short-
term or intermediate-term for uses on dichondra and sites where ornamental stock will be placed in
liners, the Agency is also establishing a requirement for thorough incorporation into the soil (or other
treated surface) through watering-in.  The Agency notes that the WPS places very specific restrictions
on entry during restricted-entry intervals when that entry involves contact with treated surfaces.  The
Agency believes that these existing WPS restrictions are sufficient to  mitigate  post-application
exposures of workers who contact surfaces treated with dichlobenil.

The REI remains 12 hours for all other use sites under WPS.

The WPS interim REI in effect until now was 12 hours (based  on early data that indicated that
dichlobenil was classified as category  III for acute dermal toxicity.)  The WPS interim REI was
established through labeling modifications specified in PR Notice 93-7, which implemented the
labeling requirements of the 1992 Worker Protection Standard.

Early-Entry  PPE: The WPS establishes very specific restrictions on entry by workers to areas that
remain under a restricted-entry interval, if the entry involves contact with treated surfaces. Among
those restrictions are a prohibition of routine entry to perform hand labor tasks and a requirement that
personal protective equipment be worn. Under  the WPS, these personal  protective equipment
requirements for persons who must enter areas that remain under a restricted-entry interval are based
on the acute toxicity category of the active ingredient.
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During the reregistration process, EPA considers all relevant product-specific information to decide
whether there is reason to set personal protective equipment requirements that differ from those set
through the WPS.

The RED requirements for early-entry personal protective equipment are set in one of two ways:

1.       If EPA determines that no regulatory action must be taken as the result of the acute effects
       or other adverse effects of an active ingredient, it establishes the early-entry PPE requirements
       on the basis of the acute  dermal toxicity category,  skin irritation potential category, and eye
       irritation potential category of the active ingredient.

2.      If EPA determines that regulatory action on an active ingredient must be taken as the result
       of very high acute toxicity or to certain other adverse effects, such as allergic effects  or
       delayed effects (cancer, developmental toxicity, reproductive effects), it may establish early-
       entry PPE requirements that are more stringent than would be established otherwise.

There are no data to evaluate the post-application risk to this chemical. However, the Agency is
taking steps to reduce post-application inhalation exposures by establishing a 24-hour restricted entry
interval and requiring thorough  incorporation through watering-in after application to horticultural
and nursery uses.  In conjunction with these protective measures, the Agency is establishing PPE for
dermal protection based on the acute toxicity of the active ingredient. Dichlobenil is classified  as
toxicity category III for acute dermal toxicity and toxicity category IV for skin irritation potential.
Since dichlobenil is classified as category IV for eye irritation potential, protective eyewear is not
required.

                            (2)    Occupational-Use Products (NonWPS Uses)

The Agency is establishing entry  restrictions for some nonWPS occupational uses of dichlobenil end-
use products. Due to concerns about inhalation exposures from sewer treatments, the Agency is
establishing a requirement  for all uses in connection  with inhabited buildings (residences, offices,
hospitals, etc.) specifying that windows must be open or an exhaust fan must be operating during the
application. For specific language,  refer to Section V of this document.

                            (3)    Homeowner-Use Products

Due to concerns about  possible dermal  and inhalation exposures from soil contact soon after
application, the Agency is recommending thorough incorporation through watering-in for all soil uses
(around established ornamental trees and shrubs, and outdoor non-crop areas  such as buildings,
fences,  and other structures) on products primarily intended for homeowner use.  Entry would be
restricted until the soil is  dry following the watering-in.
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              8.      Ground-Water Advisory

As explained above dichlobenil and its principal metabolite BAM have the potential to leach into
groundwater. Therefore, a groundwater advisory is required for all dichlobenil products.
              9.     Application Rate Reduction

Because of risk concerns for birds, fish, aquatic invertebrates, mollusks, and non-target plants at the
20 Ib. ai/A application rate, the Agency is requiring that the maximum application rate for dichlobenil
not exceed 10 Ib. ai/A. Sites with maximum application rates at 20 Ib. ai/A include drainage systems,
rights-of-way,  fencerow, hedgerow, cemeteries, and  on industrial, recreational,  and uncultivated
areas. The application rates at these use sites must be reduced to a maximum application rate <  10
Ib. ai/A.

              10.    10G Soil Incorporation Requirements

Because of a potential risk to birds from unincorporated applications of the 10G formulation, soil
incorporation  or watering-in is required for all use sites on the 10G labels other than pre-paving.
Exposure to birds to the 10G formulation applied at pre-paving sites is expected to be limited
provided the applicator follows the manufacturer's recommendation to cover the treated area as soon
as possible with asphalt.
V.     ACTIONS REQUIRED OF REGISTRANTS

This section specifies the data requirements and responses necessary for the reregi strati on of both
manufacturing-use and end-use products.

       A.     Manufacturing-Use Products

              1.     Additional Generic Data Requirements

The generic data base supporting the reregistration of dichlobenil for the above eligible uses has been
reviewed and determined to be substantially complete. However, the following additional data are
outstanding and are now required.
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                     a.     Requirements for Handler (Mixer/Loader/Applicator) Exposure
                           Studies

A dermal exposure study (Guideline 231) and an inhalation exposure study (Guideline 232) are
required for the following mixer, loader, and applicator scenarios:

•      use of backpack applications of granular formulations for landscape treatment.

•      all application of dichlobenil to sewer pipes except formulations applied by flushing down
       toilet bowl.

These studies should be  conducted concurrently, i.e., dermal and inhalation samples should be
collected from the same handler and at the same site during each trial.

                     b.     Requirements for Post-Application Studies

Post-application exposure studies for applications to ornamentals are required at this time. Guidelines
132-l(a) Foliar residue dissipation, 132-1 (b) Soil  residue dissipation, 133-3  Dermal  passive
dosimetry exposure, 133-4 Inhalation passive dosimetry exposure are required for dichlobenil.

Guideline 132-lb is required for both  dichlobenil and BAM. These studies should be conducted
concurrently, i.e., dermal and inhalation samples should be collected from the same worker and at the
same site during each trial.

                     c.     Requirements for  BAM Chemistry and Environmental  Fate
                           Studies

Guidelines 63-8 Solubility and 63-9 Vapor pressure are required for BAM. If it is determined that
the Henry's constant for BAM is less than 10"5,  then the following environmental fate data are also
required for BAM: 161-2 photodegradation in water, 162-1 Aerobic soil metabolism, 162-4 Aerobic
aquatic metabolism, and 163-1  Adsorption/desorption.

                     d.     Requirements for Drinking-Water Monitoring Studies

The drinking water monitoring study should have samples from existing drinking water wells.  The
samples should be from drinking water wells in  dichlobenil use areas and taken as close as possible
to treated fields.  Sampling should analyze for both the parent and the degradate BAM. When
possible, sampling should include, but not limited to, wells near cranberry fields, nurseries, turf sites,
and several non-agricultural uses such as rights-of way,  hedge/fence row treatment and home owner
use, however not sewers and "under asphalt." All studies must use protocols that have been reviewed
and approved by OPP. The drinking water study results will be used to determining if any additional
ground water mitigation measures or prospective groundwater studies are needed.
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                     e.     Requirements for Prospective Groundwater Monitoring Studies

At this time the groundwater monitoring studies are only required to support hybrid cottonwood-
poplar plantation use  sites. One or more small-scale prospective ground water studies need to be
conducted to support hybrid cottonwood poplar production sites in areas outside the eastern desert
areas of Oregon and Washington.  Alternatively, registrants may modify the label to geographically
limit the use of dichlobenil on hybrid cottonwood-poplar plantations to the desert areas in Oregon
and Washington defined as 15 miles from the Columbia river in the counties of Walla Walla, Franklin
and Benton in Washington and Umatilla and Morrow in Oregon.

                     f.     Requirements for Forestry Dissipation

The forestry dissipation study is required to support the use of dichlobenil in hybrid cottonwood-
poplar pulpwood  production areas outside a defined area of the eastern Oregon-Washington desert
which is 15 miles from the Columbia river in the counties of Walla Walla, Franklin and Benton in
Washington and Umatilla and Morrow in Oregon.  Alternatively, registrants may modify the label to
geographically limit the use  of dichlobenil on hybrid cottonwood-poplar plantations to the desert
areas in Oregon and Washington defined above.

                     g.     Requirements for Avian Reproduction Studies

Avian reproduction studies (Guideline 71-4) preferably with bobwhite quail and mallard duck are
required on the technical grade of dichlobenil.

              2.      Labeling Requirements for Manufacturing-Use Products

To remain in compliance with FIFRA, manufacturing use product (MP) labeling must be revised to
comply with all current EPA regulations, PR Notices and applicable policies. The MP labeling must
bear the following statement under Directions for Use:

       "Only for formulation into a Herbicide for the following use(s)	[fill blank only with
       those uses that are being supported by MP registrant.]"

References to "fruit crops" and "nut crops" as sites should be removed from the label if this  has not
already been done,  since these general sites are unsupported.

A MP registrant may, at his/her discretion, add one of the following statements to an MP label under
"Directions for Use" to permit the reformulation of the product for a specific use or all additional uses
supported by a formulator or user  group:

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

       B.     End-Use Products

              1.     Additional Product-Specific Data Requirements

Section 4(g)(2)(B) of FIFRA calls  for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. The product specific data
requirements are listed in Appendix G, the Product Specific Data Call-In Notice.

Registrants must review previous data submissions to ensure that they meet current EPA acceptance
criteria (Appendix F; Attachment E) and if not, commit to conduct new studies.  If a registrant
believes that previously submitted data meet current testing standards, then study MRID numbers
should be cited according to the instructions in the Requirement Status and Registrants Response
Form provided for each product.

              2.     Labeling Requirements for End-Use Products

When end-use product DCIs are developed (e.g., at issuance of the RED), all end-use product labels
should be amended such that they are consistent with the basic producer labels.

                    a.     Ground-Water Advisory

The label must state the following:

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

                    b.     Application Rate Reduction

Use rates at sites with maximum application rates at 20 Ib. ai/A, including drainage systems, rights-of-
way, fencerow, hedgerow, cemeteries, in industrial areas, recreational areas, and uncultivated areas
must be reduced so the maximum application rates listed on the  label are  < 10 Ibs ai/A.

                    c.     10G Soil Incorporation Requirements

The labels for the 10G formulation must impose for all uses other  than pre-paving sites that the user
thoroughly incorporate  the granules into the soil.  The 10G may also be subject to incorporation
requirements indicated below.
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                    d.     Occupational Labeling

The labels and labeling of all products must comply with EPA's current regulations and requirements
as specified in 40 CFR §156.10 and other applicable notices.

                           (1)    PPE Requirements for Pesticide Handlers

Sole-active-ingredient end-use products that contain  dichlobenil  must be revised to adopt the
handler personal protective equipment requirements set forth in this section.  Any conflicting PPE
requirements on their current labeling must be removed.

Multiple-active-ingredient end-use products that contain dichlobenil must compare the handler
personal protective equipment requirements set forth in this section to the PPE requirements on their
current labeling and retain the more protective.  For guidance  on which PPE is considered more
protective, see PR Notice 93-7.

                                 (a)    PPE   Requirements   for   Products   Intended
                                        Primarily for Occupational Use

Actual end-use product PPE requirements — The PPE that would otherwise be established based
on the acute toxicity of each end-use product must be compared to the minimum (baseline) personal
protective equipment, if any, specified below. The more protective  PPE must be placed on the
product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.

Placement in labeling — The personal protective equipment must be placed on the end-use product
labeling in the location specified in PR Notice 93-7  and the format and language of the PPE
requirements must be the same as  is specified in PR Notice 93-7.

Minimum (baseline) PPE requirements — Some of the registered uses  of dichlobenil are within the
scope of the WPS and some are outside the scope of the WPS.   The minimum (baseline) PPE
requirements pertain to both the WPS and nonWPS uses by occupational  handlers, since the potential
exposure is similar for WPS and nonWPS uses.

Wettable Powder Formulations

Asphalt Use: The minimum (baseline) PPE for all occupational uses of dichlobenil end-use products
formulated as wettable powders for the asphalt use is:

"Applicators and other handlers (other than mixers and  loaders) must wear:
       —Long-sleeved shirt and long pants
       -Shoes plus socks"
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Mixers and loaders must wear:
       -Long-sleeved shirt and long pants
       —Shoes plus socks
       -Chemical-resistant gloves,
       —Chemical-resistant apron.

Sewer Use: The minimum (baseline) PPE for applicator and other handlers (other than mixers
and loaders) occupational uses of dichlobenil end-use products formulated as wettable powders and
labeled for use in sewer sites is:

"Applicators and other handlers (other than mixers and loaders) must wear:
       -Long-sleeved shirt and long pants,
       —Shoes plus socks, and
       -Chemical-resistant gloves"

       Mixers and loaders must wear:
       —Long-sleeved shirt and long pants,
       —Shoes plus socks,
       —Chemical-resistant gloves,
       -Chemical-resistant apron.

Granular Formulations

The minimum (baseline) PPE for all occupational uses of dichlobenil end-use products formulated as
granulars is:

       "Applicators and other handlers must wear:
       -Long-sleeved shirt and long pants
       —Shoes plus socks
       —Chemical-resistant gloves when mixing or loading."

Respirator Type

If the acute inhalation toxicity of the end-use product is in category I or II, a respirator is required
for pesticide handlers. The following type of respirator is appropriate to  mitigate dichlobenil
inhalation concerns:

       "A respirator with either an organic-vapor-removing cartridge with a prefilter approved for
       pesticides (MSHA/NIOSH approval number  prefix  TC-23C), or a canister approved for
       pesticides (MSHA/NIOSH approval number prefix TC-14G)"
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                                  (b)    PPE   Requirements   for   Products   Intended
                                         Primarily for Homeowner Use

There are no minimum (baseline) PPE being established for homeowner uses of dichlobenil end-use
products formulated as granulars.

                           (2)    Post-Application/Entry Restrictions for Products Intended
                                  Primarily for Occupational Use

WPS uses

Restricted-entry  interval  —  a  24-hour  restricted  entry  interval (REI)  is  required  for
horticultural/nursery uses within the scope of the WPS (see PR Notice 93-7)  on all end-use products
with WPS uses (see tests in PR Notices 93-7 and 93-11). The REI for all other uses within the scope
of WPS is 12 hours.

Exception: If the product is soil-injected or soil incorporated, the Worker Protection Standard, under
certain  circumstances allows workers to enter the treated area if there will be no contact with
anything that has been treated.

Early-entry personal protective equipment (PPE) —
The PPE required for early entry following applications is:
       -Coveralls,
       —Chemical-resistant gloves, and
       —Shoes plus socks.

Placement in labeling — The REI must be inserted into the standardized REI statement required by
Supplement Three of PR Notice 93-7.  The PPE required for early entry must be inserted into the
standardized early entry PPE statement required by Supplement Three of PR Notice 93-7.

NonWPS uses

Entry restrictions —

There are no nonWPS entry restrictions for outdoor uses on shelterbelt plantings, rights-of-way,
fence rows, hedge rows, pre-paving treatment, uncultivated areas, buildings and structures, industrial
and recreational areas, and sewage and drainage systems.

For uses on  ornamental  woody shrubs and vines, ornamental/shade trees,  and residential and
commercial landscaping:

"Do not enter or allow workers to enter the treated area until granules are thoroughly watered in and
the  treated soil has dried.".
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                           (3)    Post-Application/Entry Restrictions for Products Intended
                                  Primarily for Home Use

"Do not enter or allow persons or pets to enter the treated area until granules are thoroughly watered
in and the treated soil has dried."

                           (4)    Other Labeling Requirements  for Products  Intended
                                  Primarily for Occupational Use

The Agency is requiring the following labeling statements to be located on all end-use products
containing dichlobenil that are intended primarily for occupational use.

Application Restrictions:

For Granular Formulations:
"Do not apply this product in a way that will contact workers of other persons, either directly or
through drift. Only protected handlers may be in the area during application."

For Granular Formulations With Use Directions on Ground (Soil or Gravel) in  Liners in
Which Ornamental Stock Will Be Placed: (associate the following statement with the directions
for this use)
"Thoroughly incorporate the granules into the soil (or other target surface) through watering-in. Once
the application has been correctly incorporated through watering-in and the treated surface is dry, the
WPS permits workers to enter the treated area during the restricted-entry interval without personal
protective equipment or any other restriction if they are performing tasks that do not involve contact
with the soil subsurface."

For Wettable Powder Formulations with Directions for Sewer Treatments:
"When used in inhabited buildings (residences, offices, hospitals, etc.), windows must be open or an
exhaust fan must be operating during the application."

Engineering Controls:

For wettable powder formulations:
"When handlers use closed systems (including water soluble bags) or enclosed cabs in a manner that
meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides
(40 CFR 170.240(d)(4-6), the handler PPE requirements may be reduced or modified as specified in
the WPS."

For granular formulations that may be applied from enclosed cabs or  aircraft:
"When handlers use enclosed cabs or aircraft in a manner that meets the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6), the handler
PPE requirements may be reduced or modified as specified in the WPS."
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User Safety Requirements:

"Follow manufacturer's instructions for cleaning/maintaining PPE. If there are no such instructions
for washable PPE, use detergent and hot water. Keep and wash PPE separately from other laundry."

User Safety Recommendations:

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

•      "Users should remove clothing immediately if pesticide gets inside. Then wash thoroughly
       and put on clean clothing."

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

                            (5)    Other Labeling  Requirements  for  Products  Intended
                                  Primarily for Home Use

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

Immediately following  application, thoroughly water-in the granules.

User safety recommendations

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

•      "Users should remove clothing immediately if pesticide gets inside. Then wash thoroughly
       and put on clean clothing."

       C.      Tolerance Revocation and Import Tolerances

"The citrus, figs, mangoes, nuts (other than filberts), and  stone fruits (other than cherries) uses of
dichlobenil were voluntarily cancelled during EPA's preparation of the  reregi strati on eligibility
decision regarding this pesticide.  It is the Agency's policy to propose revocation of a tolerance,
and/or food/feed additive regulation, following the deletion of a related food use from a registration,
or following the cancellation of a related food-use registration. As a result, any parties interested in
supporting the tolerance/regulation for import purposes in the absence of a registered U.S. use should
notify EPA as soon as possible.
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In responding, the Agency will provide detailed information on the outstanding data requirements for
these tolerances and/or regulations.  The Agency will consider commitments made to generate data
to support such tolerances/regulations and the timeliness of data submissions in its assessment of
whether the tolerances/regulations should be retained.  Persons interested in establishing a new
tolerance for import purposes only, or retaining a current tolerance for import purposes following
cancellation of the related use, must submit a petition along with the appropriate fees and supporting
data."

              D.     Existing Stocks

Registrants may generally distribute and sell products bearing old labels/labeling for 26 months from
the date of the issuance of this Reregistration Eligibility Decision (RED). Persons other than the
registrant may generally distribute or sell such products for 50 months from the date of the issuance
of this RED. However, existing stocks time frames  will be established on a case-by-case basis,
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 registrants may distribute and  sell dichlobenil products bearing old
labels/labeling for 26 months from the date of issuance of this RED. Persons other than the registrant
may distribute  or sell  such products for 50 months  from the date of the issuance of this RED.
Registrants and persons other than registrants remain obligated to meet pre-existing Agency imposed
label changes and existing stocks requirements applicable to products they sell or distribute.
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VI. APPENDICES
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                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical 027401  [Dichlobenil]
LUIS 2.0  )  Page 1
SITE Application Type, Application        Form(s)  Min. Appl.      Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.     Geographic Limitations       Use
  Timing, Application Equipment  )                 Rate  (AI un-      Rate  (AI Tex. @ Max. Rate unless noted    Interv Entry   Allowed            Disallowed    Limitations
  Surface Type  (Antimicrobial only) & Effica-      less noted    unless noted Max. /crop /year otherwise)/A]    (days) Interv                                  Codes
  cy Influencing Factor (Antimicrobial only)       otherwise)      otherwise) Dose cycle       /crop    /year          [day(s)]
                                                                                               cycle


USES ELIGIBLE FOR REREGISTRATION

FOOD/FEED USES
                                                                         Use Group: TERRESTRIAL FOOD+FEED CROP

                                                                       o ib A	*—m	m	fr-*te	m-
                                                                                                            NS   NS     NS
Soil treatment., Bearing., Not on label.     G     NA

                                             G     NA

                                                   NA
Soil treatment.,  Early winter.,  Package      G
applicator.

Soil treatment.,  Late fall., Not on label.   G
                                                                 1.406E-04 Ib
                                                                        sq.ft
                                                               .006 tbsp sq.ft
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                                                               APPENDIX  A  )   CASE  0263,  [Dichlobenil]  Chemical 027401 [Dichlobenil]
                                                                                                                   LUIS 2.0  )   Page 2
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only)  & Effica-
  cy Influencing Factor  (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
Form(s)   Min. Appl.      Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.      Geographic  Limitations       Use
         Rate (AI un-      Rate  (AI Tex. @ Max. Rate unless noted     Interv Entry   Allowed            Disallowed   Limitations
         less noted    unless noted Max. /crop /year otherwise)/A]    (days) Interv                                  Codes
                         otherwise) Dose cycle       /crop    /year          [day(s)]
                                                     cycle
APPLE  (con't)
                                                                          Use  Group:  TERRESTRIAL FOOD+FEED CROP (con't)

                                                                          Ib A   *   NS     NS       6 Ib      NS   NS

                                                                          Ib A   *   NS     NS         NS      NS   NS
                                                                                                   0 Ib
                                                                                                            -tiS-
                                                                                                                   604

                                                                                                                   604
        Hullbe
                                                                                                   0 Ib
                 Nonbc
                                                                                                   0 Ib
                                                                          Use  Group:  TERRESTRIAL FOOD CROP
                                                                        4  Ib  A
Soil treatment., Late fall., Not on label.
                                                               .004  tbsp  sq.ft
                                                                  9.375E-05  Ib
                                                                         sq.ft
                                                               .004  tbsp  sq.ft

                                                               .004  tbsp  sq.ft
                                                                  9.375E-05  Ib
                                                                         sq.ft
                                                               .004  tbsp  sq.ft
                                                                                            114

-------
                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical  027401  [Dichlobenil]
LUIS 2.0  )  Page 3
SITE Application Type, Application        Form(s)  Min. Appl.      Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.      Geographic  Limitations       Use
  Timing, Application Equipment  )                 Rate  (AI un-      Rate  (AI Tex. @ Max. Rate unless noted     Interv Entry   Allowed            Disallowed    Limitations
  Surface Type  (Antimicrobial only) & Effica-      less noted    unless noted Max. /crop /year otherwise)/A]    (days) Interv                                  Codes
  cy Influencing Factor  (Antimicrobial only)       otherwise)      otherwise) Dose cycle       /crop    /year          [day(s)]
                                                                                               cycle

USES ELIGIBLE FOR REREGISTRATION
BLACKBERRY (con't)
BLUEBERRY
Soil treatment., Bearing., Not on label.
                                                                                                    NS      NS   NS
                                                                 1.406E-04 Ib
                                                                        sq.ft
                                                               .006 tbsp sq.ft
                                                                                                    NS      NS   NS
                                                                                           115

-------
                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical  027401  [Dichlobenil]
LUIS 2.0  )  Page 4
SITE Application Type, Application        Form(s)  Min. Appl.      Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.   Restr.      Geographic  Limitations       Use
  Timing, Application Equipment  )                 Rate  (AI un-      Rate  (AI Tex. @ Max. Rate unless noted     Interv  Entry   Allowed            Disallowed   Limitations
  Surface Type  (Antimicrobial only) & Effica-      less noted    unless noted Max. /crop /year otherwise)/A]    (days)  Interv                                  Codes
  cy Influencing Factor  (Antimicrobial only)       otherwise)      otherwise) Dose cycle       /crop    /year          [day(s)]
                                                                                               cycle

USES ELIGIBLE FOR REREGISTRATION
BLUEBERRY (con't)

Soil treatment., Late fall., Not on label.   G     NA
                                                                 1.406E-04 Ib
                                                                        sq.ft
                                                               .006 tbsp sq.ft
                                                                                                    NS      NS   NS      NS


                                                                                                   6 Ib      NS   NS      NS

                                                                                                    NS      NS   NS      NS

                                                                                                   6 Ib      NS   NS      NS
                                                                                                   6  Ib
                                                                         Use Group: TERRESTRIAL  FOOD CROP
Soil treatment., Bearing., Not on label.     G
                                                                 1.406E-04 Ib
                                                                        sq.ft
                                                               .006 tbsp sq.ft
                                                                                           116

-------
                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical  027401  [Dichlobenil]
                                                                                    LUIS 2.0  )  Page 5
SITE Application Type, Application        Form(s)  Min. Appl.      Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.      Geographic Limitations       Use
  Timing, Application Equipment  )                 Rate  (AI un-      Rate  (AI Tex. @ Max. Rate unless noted     Interv Entry   Allowed            Disallowed    Limitations
  Surface Type  (Antimicrobial only) & Effica-      less noted    unless noted Max. /crop /year otherwise)/A]    (days) Interv                                  Codes
  cy Influencing Factor (Antimicrobial only)       otherwise)      otherwise) Dose cycle       /crop    /year          [day(s)]
                                                                                               cycle

USES ELIGIBLE FOR REREGISTRATION
Soil treatment., Early winter., Package      G
applicator.

Soil treatment., Late fall., Not on label.   G
                                                                 1.406E-04 Ib
                                                                        sq.ft
                                                               .006 tbsp sq.ft
CRANBERRY

Soil treatment., Postharvest.,  Not on label.

Soil treatment., Prebloom.,  Not on label.
Use Group: TERRESTRIAL FOOD CROP

                           NS      NS   NS

                           NS      NS   NS

        p: TERRESTRIAL FOOD CROP




Opray., Nurjcryjtuc
G NA




6 Ib A




* NS




NS




NS




NS




NS



nn
NS GO 4




                                                                                           117

-------
                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical 027401  [Dichlobenil]
LUIS 2.0  )  Page 6
SITE Application Type, Application        Form(s)  Min.  Appl.       Max.  Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.     Geographic Limitations       Use
  Timing, Application Equipment  )                 Rate  (AI un-      Rate  (AI Tex. @ Max. Rate unless noted    Interv Entry   Allowed            Disallowed    Limitations
  Surface Type  (Antimicrobial only) & Effica-      less noted    unless noted Max. /crop /year otherwise)/A]    (days) Interv                                  Codes
  cy Influencing Factor (Antimicrobial only)       otherwise)       otherwise) Dose cycle       /crop    /year          [day(s)]
                                                                                               cycle

USES ELIGIBLE FOR REREGISTRATION
Soil treatment., Bearing., Not on label.
Soil treatment., Early spring., Package
applicator.

Soil treatment., Early winter., Not on
label.
                                                                       6 Ib A

                                                                 1.406E-04 Ib
                                                                        sq.ft
                                                              .006 tbsp sq.ft
Soil treatment., Early winter., Package      G
applicator.

Soil treatment., Late fall., Not on label.   G
                                                                 1.406E-04 Ib
                                                                        sq.ft
                                                              .006 tbsp sq.ft
                                                                                           118

-------
                                                               APPENDIX A   )  CASE  0263,  [Dichlobenil]  Chemical  027401  [Dichlobenil]
                                                                                                                    LUIS  2.0   )   Page  7
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
Form(s)   Min.  Appl.      Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.     Geographic Limitations       Use
         Rate (AI un-      Rate (AI Tex. @ Max. Rate unless noted    Interv Entry   Allowed            Disallowed    Limitations
         less noted    unless noted Max. /crop /year otherwise)/A]   (days) Interv                                  Codes
                         otherwise) Dose cycle       /crop    /year          [day(s)]
                                                     cycle
FILBERT (HAZELNUT)  (con't)
                                                                         Use  Group:  TERRESTRIAL  FOOD+FEED  CROP

                                                                         Ib A	*	m	m	fr-*te	MS	ttS-
Soil treatment., Bearing., Not on label.     G
                                                                 1.406E-04  Ib
                                                                         sq.ft
                                                               .006 tbsp  sq.ft
                                                                                           119

-------
                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical  027401  [Dichlobenil]
LUIS 2.0  )  Page 8
SITE Application Type, Application        Form(s)  Min. Appl.      Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.   Restr.      Geographic  Limitations       Use
  Timing, Application Equipment  )                 Rate  (AI un-      Rate  (AI Tex. @ Max. Rate unless  noted     Interv  Entry   Allowed            Disallowed   Limitations
  Surface Type  (Antimicrobial only) & Effica-      less noted    unless noted Max. /crop /year otherwise)/A]    (days)  Interv                                  Codes
  cy Influencing Factor  (Antimicrobial only)       otherwise)      otherwise) Dose cycle       /crop    /year          [day(s)]
                                                                                               cycle

USES ELIGIBLE FOR REREGISTRATION
GRAPES (con't)
                                                                         Use Group: TERRESTRIAL  FOOD+FEED CROP  (con't)

                                                               .006 tbsp sq.ft   *  NS    NS         NS      NS   NS      NS
Soil treatment., Early winter., Package
applicator.

Soil treatment., Late fall., Not on label.
                                                                 1.406E-04 Ib
                                                                        sq.ft
                                                               .006 tbsp sq.ft
                                                                                                    NS
                                                                                                                         NS
                                                                                           120

-------
                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical  027401  [Dichlobenil]
                                                                                                                   LUIS 2.0  )  Page  9
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor (Antimicrobial only)
Form(s)   Min.  Appl.       Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.     Geographic Limitations      Use
         Rate (AI un-      Rate (AI Tex. @ Max. Rate unless noted    Interv Entry   Allowed           Disallowed   Limitations
         less noted    unless noted Max. /crop /year otherwise)/A]   (days) Interv                                 Codes
                         otherwise) Dose cycle       /crop    /year         [day(s)]
                                                     cycle
USES ELIGIBLE FOR REREGISTRATION
                                                                                                                                                             001,
                                                                                                                                                             001,
                                                                                                                                                             001,
                                                                                                                                                             001,
                                                                                                                                                             001,
                                                                                    TERRESTRIAL FOOD I FEED CROP
                                                                                           121

-------
                                                               APPENDIX A   )  CASE  0263,  [Dichlobenil]  Chemical  027401  [Dichlobenil]
                                                                                                          LUIS  2.0   )   Page  10
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
                                                                   Max. Appl. Soil Max.  # Apps Max.  Dose  [(AI    Min.   Restr.
Rate (AI un-      Rate  (AI Tex. @ Max. Rate unless noted
less noted    unless noted Max. /crop /year otherwise)/A]
otherwise)       otherwise) Dose cycle       /crop     /year
                                            cycle
Interv Entry   Allowed
(days)  Interv
       [day(s)]
USES ELIGIBLE FOR REREGISTRATION

FOOD/FEED USES (con't)
                                                                                                   0  Ib
        Nunbc
                                                                                                   0  Ib
NECTARINE
                                                                         Use Group:  TERRESTRIAL  FOOD  CROP
                                                                                                   0  Ib
                                                                                                                                                             604,  HOI(30)
Soil treatment., Bearing., Not on label.
Soil treatment., Early spring., Not on
label.
                                                                       6  Ib A

                                                                       6  Ib A
                                                                                           122

-------
SITE Application Type, Application
                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical  027401  [Dichlobenil]

                                                              4444444444444444444444444444444444444444444444444444444444444444444444'
                                          Form(s)  Min. Appl.      Max. Appl. Soil Max. # Apps Max. Dose  [(AI    Min.  Restr.      Geographic  Limitations
                                                                                                         LUIS  2.0   )   Page  11
  Timing, Application Equipment  )
  Surface Type (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
Rate (AI un-      Rate  (AI Tex. @ Max. Rate unless noted    Interv Entry   Allowed
less noted    unless noted Max. /crop /year otherwise)/A]   (days) Interv
otherwise)       otherwise) Dose cycle       /crop     /year         [day(s)]
                                            cycle
USES ELIGIBLE FOR REREGISTRATION

FOOD/FEED USES (con't)
NECTARINE (con't)

Soil treatment., Early winter., Not on       G     NA
label.
Soil treatment., Early winter., Package
applicator.

Soil treatment., Late fall., Not on label.
                                                                 1.406E-04 Ib
                                                                        sq.ft
                                                               .006 tbsp sq.ft
















                                                                         Use Group: TERRESTRIAL  FOOD CROP
                                                                                           123

-------
                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical  027401  [Dichlobenil]
                                                                                                         LUIS  2.0   )   Page  12
SITE Application Type, Application
                                          Form(s)  Min.  Appl.      Max. Appl. Soil Max.  # Apps Max. Dose  [(AI   Min.   Restr.      Geographic  Limitations       Use
  Timing, Application Equipment  )
  Surface Type (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
Rate (AI un-      Rate  (AI Tex. @ Max. Rate unless noted    Interv Entry   Allowed
less noted    unless noted Max. /crop /year otherwise)/A]   (days) Interv
otherwise)       otherwise) Dose cycle       /crop     /year         [day(s)]
                                            cycle
USES ELIGIBLE FOR REREGISTRATION

FOOD/FEED USES (con't)
PEACH (con't)
Soil treatment., Bearing., Not on label.     G
Soil treatment.,  Early spring.,  Not on
label.
Soil treatment., Early winter., Not on       G     NA
label.
              1.406E-04 Ib
                     sq.ft
           .006 tbsp sq.ft
Soil treatment., Late fall., Package
applicator.
                                                                                           124

-------
                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical  027401  [Dichlobenil]
LUIS 2.0  )  Page 13
SITE Application Type, Application        Form(s)  Min. Appl.      Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.      Geographic  Limitations       Use
  Timing, Application Equipment  )                 Rate  (AI un-      Rate  (AI Tex. @ Max. Rate unless noted     Interv Entry   Allowed            Disallowed    Limitations
  Surface Type  (Antimicrobial only) & Effica-      less noted    unless noted Max. /crop /year otherwise)/A]    (days) Interv                                  Codes
  cy Influencing Factor  (Antimicrobial only)       otherwise)      otherwise) Dose cycle       /crop    /year          [day(s)]
                                                                                               cycle


USES ELIGIBLE FOR REREGISTRATION

FOOD/FEED USES  (con't)
PEACH (con't)
PEAR

Directed jpray. , Nu
Use Group
Use Group



TERRE
Q
TRIAL
TERRESTRIAL

•N
„

N
^
FOOD CROP
FOOD CROP


(con't


	 MS 	



-MS 	 WS 	



-n ->
Soil treatment., Bearing., Not on label.     G
                                                                 1.406E-04 Ib
                                                                        sq.ft
                                                               .006 tbsp sq.ft
Soil treatment., Late fall., Package
applicator.
                                                                 1.406E-04 Ib
                                                                        sq.ft
                                                               .006 tbsp sq.ft
                                                                                           125

-------
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
                                                               APPENDIX A   )  CASE  0263,  [Dichlobenil]  Chemical  027401  [Dichlobenil]
                                                                   Max. Appl. Soil Max.  # Apps Max.  Dose  [(AI    Min.   Restr.
Rate (AI un-      Rate  (AI Tex. @ Max. Rate unless noted
less noted    unless noted Max. /crop /year otherwise)/A]
otherwise)       otherwise) Dose cycle       /crop     /year
                                            cycle
Interv Entry   Allowed
(days)  Interv
       [day(s)]
                                                                                                          LUIS  2.0   )   Page  14
USES ELIGIBLE FOR REREGISTRATION

FOOD/FEED USES (con't)
PEAR (con't)
                                                                         Use Group:  TERRESTRIAL  FOOD  CROP  (con't)

                                                                        6 Ib A    *  NS    NS         NS       NS    NS

                                                                        6 Ib A    *  NS    NS        6 Ib       NS    NS










PLUM


G NA












6 Ib A *









Use Group


NS









TERRE


NS









S TRIAL


NS









FOOD CROP


NS












NS












NS GO 4












Soil treatment., Bearing., Not on label.
                                                                                           126

-------
SITE Application Type, Application
                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical  027401  [Dichlobenil]

                                                              4444444444444444444444444444444444444444444444444444444444444444444444^
                                          Form(s)  Min.  Appl.      Max. Appl. Soil Max. # Apps Max. Dose  [(AI    Min.  Restr.      Geographic  Limitations
                                                                                                         LUIS 2.0   )   Page  15
  Timing, Application Equipment  )
  Surface Type (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
Rate (AI un-      Rate  (AI Tex. @ Max. Rate unless noted    Interv Entry   Allowed
less noted    unless noted Max. /crop /year otherwise)/A]   (days) Interv
otherwise)       otherwise) Dose cycle       /crop     /year         [day(s)]
                                            cycle
USES ELIGIBLE FOR REREGISTRATION

FOOD/FEED USES (con't)
Soil treatment.,  Early spring.,  Package
applicator.
                                                                 1.406E-04 Ib
                                                                        sq.ft
                                                               .006 tbsp sq.ft
                                                                         Use Group: TERRESTRIAL FOOD CROP  (con't)

                                                                       6 Ib A   *  NS    NS         NS      NS   NS

                                                                                   NS    NS         NS      NS   NS
Soil treatment.,  Early winter.,  Package
applicator.
Soil treatment., Late fall., Package
applicator.
                                                                                           127

-------
                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical  027401  [Dichlobenil]
                                                                                                         LUIS 2.0   )   Page  16
SITE Application Type, Application
                                          Form(s)  Min.  Appl.      Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.      Geographic  Limitations       Use
  Timing, Application Equipment  )
  Surface Type (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
Rate (AI un-      Rate (AI Tex. @ Max. Rate unless noted    Interv Entry   Allowed
less noted    unless noted Max. /crop /year otherwise)/A]   (days) Interv
otherwise)       otherwise) Dose cycle       /crop    /year         [day(s)]
                                            cycle
USES ELIGIBLE FOR REREGISTRATION

FOOD/FEED USES (con't)
Soil treatment., Bearing., Not on label.     G
Soil treatment.,  Early spring.,  Not on       G
label.
Soil treatment., Early winter., Not on       G     NA
label.
              1.406E-04 Ib
                     sq.ft
           .006 tbsp sq.ft
Soil treatment., Late fall., Package
applicator.
                                                                                           128

-------
                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical  027401  [Dichlobenil]
LUIS 2.0  )  Page 17
SITE Application Type, Application        Form(s)  Min. Appl.      Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.      Geographic  Limitations       Use
  Timing, Application Equipment  )                 Rate  (AI un-      Rate  (AI Tex. @ Max. Rate unless noted     Interv Entry   Allowed            Disallowed    Limitations
  Surface Type  (Antimicrobial only) & Effica-      less noted    unless noted Max. /crop /year otherwise)/A]    (days) Interv                                  Codes
  cy Influencing Factor  (Antimicrobial only)       otherwise)      otherwise) Dose cycle       /crop    /year          [day(s)]
                                                                                               cycle


USES ELIGIBLE FOR REREGISTRATION

FOOD/FEED USES  (con't)
Soil treatment., Early spring., Package
applicator.

Soil treatment., Early winter., Not on
label.
Soil treatment., Early winter., Package      G
applicator.

Soil treatment., Late fall., Not on label.   G
                                                                 9.375E-05 Ib
                                                                        sq.ft
                                                               .004 tbsp sq.ft
                                                               .004 tbsp sq.ft   *  NS    NS
                                                                 9.375E-05 Ib   *
                                                                        sq.ft
                                                               .004 tbsp sq.ft   *

                                                               .004 tbsp sq.ft   *  NS    NS
                                                                       4 Ib A   *  NS    NS
                                                                                           129

-------
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
                                                               APPENDIX A   )  CASE  0263,  [Dichlobenil]  Chemical  027401  [Dichlobenil]
                                                                   Max. Appl.  Soil Max.  # Apps Max.  Dose  [(AI    Min.   Restr.
                                                                                                          LUIS  2.0   )   Page  18
Rate (AI un-      Rate  (AI Tex. @ Max. Rate unless noted
less noted    unless noted Max. /crop /year otherwise)/A]
otherwise)       otherwise) Dose cycle       /crop     /year
                                            cycle
Interv Entry   Allowed
(days)  Interv
       [day(s)]
USES ELIGIBLE FOR REREGISTRATION

FOOD/FEED USES  (con't)
                                                                                                   0  Ib
                                                                                                   0  Ib
                                                                                                   0  Ib
                    -tte
                            label.
AGRICULTURAL RIGHTS-OF-WAY/FENCEROWS/HEDGEROWS
Soil treatment., When needed., Not on label. G
AGRICULTURAL UNCULTIVATED AREAS
Soil treatment., When needed., Not on label. G
                                                                                           130

-------
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
                                                               APPENDIX A   )  CASE  0263,  [Dichlobenil]  Chemical  027401  [Dichlobenil]
                                                                   Max. Appl.  Soil Max.  # Apps Max.  Dose  [(AI    Min.   Restr.
Rate (AI un-      Rate  (AI Tex. @ Max. Rate unless noted
less noted    unless noted Max. /crop /year otherwise)/A]
otherwise)       otherwise) Dose cycle       /crop     /year
                                            cycle
Interv Entry   Allowed
(days)  Interv
       [day(s)]
                                                                                                          LUIS  2.0   )   Page 19
USES ELIGIBLE FOR REREGISTRATION

NON-FOOD/NON-FEED (con't)



Spray. , Postc-mcrgcncc. . , Sprayer. 	 W 	 Wft 	


U ,j v, uT wUp .
	 0 Ib A 	 ^-



-N9 	 WS 	



	 6— ito 	 WS 	 WS 	 N9
Soil treatment., When needed., Granule
applicator.
                                             6
Soil treatment., When needed., Not on label. G

                                             G
NONAGRICULTURAL RIGHTS-OF-WAY/FENCEROWS/HEDGEROWS

Broadcast., When needed., Not on label.      G

Prepaying treatment., When needed., Not on   G
label.
                                                                         Use  Group:  TERRESTRIAL  NON-FOOD  CROP

                                                                      20 Ib A   *  NS     NS          NS       NS    NS

                                                                      20 Ib A   *  NS     NS          NS       NS    NS


                                                                                                     NS
                      Use Group: TERRESTRIAL NON-FOOD CROP

                   20 Ib A   *  NS    NS         NS      NS   NS

           .28 Ib IK sq.ft   *  NS    NS         NS      NS   NS
                                                               .28 Ib  IK  sq.ft
                                                                       12  Ib A
                                                                                           131

-------
                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical  027401  [Dichlobenil]
                                                                                      LUIS 2.0  )  Page 20
SITE Application Type, Application        Form(s)  Min. Appl.      Max. Appl. Soil Max.  # Apps Max. Dose  [(AI   Min.   Restr.      Geographic  Limitations       Use
  Timing, Application Equipment  )                 Rate  (AI un-      Rate  (AI Tex. @ Max. Rate unless  noted     Interv  Entry   Allowed            Disallowed   Limitations
  Surface Type  (Antimicrobial only) & Effica-      less noted    unless noted Max. /crop /year otherwise)/A]    (days)  Interv                                  Codes
  cy Influencing Factor  (Antimicrobial only)       otherwise)      otherwise) Dose cycle       /crop    /year          [day(s)]
                                                                                               cycle


USES ELIGIBLE FOR REREGISTRATION

NON-FOOD/NON-FEED (con't)
NONAGRICULTURAL RIGHTS-OF-WAY/FENCEROWS/HEDGEROWS
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS

Broadcast., When needed., Not on label.
                                                   NA

                                                   NA
   Use Group: TERRESTRIAL NON-FOOD CROP

20 Ib A   *  NS    NS         NS      NS   NS     NS

20 Ib A   *  NS    NS         NS      NS   NS     NS
                                                                                                    NS
                                                                                                                         NS
Soil treatment., When needed., Not on label. G

Soil treatment., When needed.,               G
Tractor-mounted granule applicator.

ORNAMENTAL AND/OR SHADE TREES
Not on label.
                                                                         Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL



Soil incorporated treatment. , Nurserystock . , G



NA



8 Ib A



* NS



NS



8 Ib



NS



NS



NS 603
                                                                 9.375E-05 Ib
                                                                        sq.ft
                                                               .004 tbsp sq.ft

                                                               .004 tbsp sq.ft
                                                                                           132

-------
                                                               APPENDIX A   )  CASE  0263,  [Dichlobenil]  Chemical  027401  [Dichlobenil]
                                                                                                          LUIS  2.0   )   Page  21
SITE Application Type, Application
                                          Form(s)  Min. Appl.      Max. Appl. Soil Max.  # Apps Max.  Dose  [(AI    Min.   Restr.      Geographic Limitations      Use
  Timing, Application Equipment  )
  Surface Type (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
Rate (AI un-      Rate  (AI Tex. @ Max. Rate unless noted    Interv Entry   Allowed
less noted    unless noted Max. /crop /year otherwise)/A]   (days) Interv
otherwise)       otherwise) Dose cycle       /crop     /year          [day(s)]
                                            cycle
USES ELIGIBLE FOR REREGISTRATION

NON-FOOD/NON-FEED (con't)
ORNAMENTAL AND/OR SHADE TREES  (con't)

Soil treatment., Early winter., Not on
label.
Soil treatment., Early winter., Package      G
applicator.

Soil treatment., Late fall., Not on label.   G
Soil treatment., When needed., Glove.

Oprav., Nurjcrvjtuck.,  Opravcr.	
                                                                  9.375E-05  Ib    *
                                                                        sq.ft
                                                               .004 tbsp sq.ft    *

                                                               .004 tbsp sq.ft    *  NS    NS
                                                                       8 Ib A    *  NS    NS
                                                                  9.375E-05  Ib
                                                                        sq.ft

                                                                  9.375E-05  Ib
                                                                        sq.ft

                                                                .2 Ib IK sq.ft
ORNAMENTAL LAWNS AND TURF

Broadcast., Winter., Aircraft.

Broadcast., Winter., Ground.
NA

NA
          Use Group:  TERRESTRIAL NON-FOOD CROP

        2  Ib A   *  NS  1/1 yr       NS      NS   NS     NS   CA

        2  Ib A   *  NS  1/1 yr       NS      NS   NS     NS   CA

          Use Group:  TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL

.2  Ib IK sq.ft   *  NS    NS         NS      NS   42     NS
                                                                                           133

-------
                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical  027401  [Dichlobenil]
LUIS 2.0  )  Page 22
SITE Application Type, Application        Form(s)  Min. Appl.      Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.      Geographic  Limitations       Use
  Timing, Application Equipment  )                 Rate  (AI un-      Rate  (AI Tex. @ Max. Rate unless noted     Interv Entry   Allowed            Disallowed   Limitations
  Surface Type  (Antimicrobial only) & Effica-      less noted    unless noted Max. /crop /year otherwise)/A]    (days) Interv                                  Codes
  cy Influencing Factor  (Antimicrobial only)       otherwise)      otherwise) Dose cycle       /crop    /year          [day(s)]
                                                                                               cycle


USES ELIGIBLE FOR REREGISTRATION

NON-FOOD/NON-FEED (con't)
                                                                       8 Ib A   *  NS    NS
                                                               .004 tbsp sq.ft   *  NS    NS
Soil treatment., Late fall., Not on label.   G
                                                                 9.375E-05 Ib   *  NS    NS
                                                                        sq.ft
                                                               .004 tbsp sq.ft   *

                                                               .004 tbsp sq.ft   *  NS    NS
                                                                 9.375E-05 Ib
                                                                        sq.ft
                                                               .004 tbsp sq.ft
                                                                 9.375E-05 Ib
                                                                        sq.ft

                                                                 9.375E-05 Ib
                                                                        sq.ft
                                                                                           134

-------
SITE Application Type, Application
                                                               APPENDIX  A  )   CASE  0263,  [Dichlobenil]  Chemical 027401 [Dichlobenil]

                                                              4444444444444444444444444444444444444444444444444444444444444444444444'
                                          Form(s)  Min. Appl.      Max.  Appl.  Soil  Max.  #  Apps Max.  Dose [(AI   Min.   Restr.     Geographic Limitations
                                                                                                                                                             LUIS 2.0  )  Page 23
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
                                                   Rate  (AI un-       Rate  (AI  Tex.  @  Max.  Rate unless noted    Interv Entry   Allowed
                                                   less  noted     unless  noted  Max.  /crop /year otherwise)/A]    (days)  Interv
                                                   otherwise)       otherwise)  Dose  cycle       /crop    /year         [day(s)]
                                                                                                cycle
USES ELIGIBLE FOR REREGISTRATION

NON-FOOD/NON-FEED (con't)
ORNAMENTAL WOODY SHRUBS AND VINES  (con't)

Soil treatment., When needed., Glove.        G
        Nu
               jtu
                                              ~#P-
                                                                          Use  Group:  TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL (con't)

                                                                .2  Ib  IK sq.ft   *   NS     NS          NS      NS   42     NS

                                                               	o  ib A	*—m	m	fr-*to	MS	MS	MS-
PAVED AREAS  (PRIVATE ROADS/SIDEWALKS)
                                             FM/L


                                             FM/L


                                             G

                                             WP
Soil treatment., When needed., Glove.

RECREATIONAL AREAS
                                             WP

                                             G
Soil treatment., When needed., Not on label.

SEWAGE SYSTEMS
                                             FM?

                                             FM/L
                                                                          Use  Group:  TERRESTRIAL NON-FOOD CROP

                                                              .252  Ib  IK sq.ft   *   NS     NS          NS      NS   NS


                                                                                                     NS
                                                                       20  Ib  A   *   NS     NS          NS      NS   NS     NS

                                                                          Use Group:  AQUATIC  NON-FOOD INDUSTRIAL

                                                                           UC   *   NS     NS          NS      NS   NS     NS
                                                                                           135

-------
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
                                                               APPENDIX A   )   CASE  0263,  [Dichlobenil]  Chemical 027401 [Dichlobenil]
                                                                   Max. Appl.  Soil  Max.  #  Apps  Max.  Dose [(AI   Min.   Restr.
                                                                                                          LUIS 2.0  )   Page 24
Rate (AI un-      Rate  (AI Tex. @ Max. Rate unless noted
less noted    unless noted Max. /crop /year otherwise)/A]
otherwise)       otherwise) Dose cycle       /crop     /year
                                            cycle
Interv Entry   Allowed
(days)  Interv
       [day(s)]
USES ELIGIBLE FOR REREGISTRATION

NON-FOOD/NON-FEED (con't)
Soak., When needed., Not on label.

Soak., When needed., Pump.

SHELTERBELT PLANTINGS

Directed spray., Nurscrystock., Or
                      Use Group: AQUATIC NON-FOOD INDUSTRIAL  (con't)

                        UC   *  NS    NS         NS      NS   NS     NS

                        UC   *  NS    NS         NS      NS   NS     NS

                        UC   *  NS    NS         NS      NS   NS     NS

                      Use Group: FORESTRY
                                                                                                   0  Ib
                                                                                                                        -tie
      5*-
                                                                        8  lb A
                                                                                           136

-------
                                                               APPENDIX A  )  CASE 0263,  [Dichlobenil] Chemical  027401  [Dichlobenil]
LUIS 2.0  )  Page 25
LEGEND
444444

  HEADER ABBREVIATIONS
  Min.  Appl.  Rate (AI unless :  Minimum dose for a single application to a single site.  System calculated.  Microbial claims only.
  noted otherwise)
  Max.  Appl.  Rate (AI unless :  Maximum dose for a single application to a single site.  System calculated.
  noted otherwise)
  Soil Tex.  Max.Dose        :  Maximum dose for a single application to a single site as related to soil texture  (Herbicide claims  only).
  Max.  # Apps @ Max. Rate    :  Maximum number of Applications at Maximum Dosage Rate.  Example: "4 applications per year"  is expressed  as  "4/1 yr";  "4  applications  per  3
                               years" is expressed as "4/3 yr"
  Max.  Dose  [(AI unless      :  Maximum dose applied to a site over a single crop cycle or year.  System calculated.
  noted otherwise)/A]
  Min.  Interv (days)         :  Minimum Interval between Applications (days)
  Restr. Entry Interv  (days) :  Restricted Entry Interval (days)
  PRO Report Date            :  LUIS contains all products that were active or suspended  (and that were available  from OPP  Document  Center)  as of  this date.   Some  products
                               registered after this date may have data included in this report, but LUIS does not guarantee that all products registered  after  this date have
                               data that has been captured.
  SOIL TEXTURE FOR MAX APP. RATE
            Non-specific
            Coarse
  M         Medium
  F         Fine
  O         Others

  FORMULATION CODES
  FM/L      FORM NOT IDENTIFIED/LIQUID
  FM?       FORM NOT IDENTIFIED
            GRANULAR
            SOLUBLE CONCENTRATE/SOLID
            WETTABLE POWDER
  ABBREVIATIONS
            As Needed
            Not Applicable
            Not Specified  (on label)
            Unconverted due to lack of data  (on label), or with one of following units: bag, bait, bait block, bait pack, bait  station, bait  station (s),  block,  briquet,
            briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains,  lure, pack, packet,  packets, pad,  part,
            parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets,  tag,  tape, towelette,  tray,  unit,  --
  APPLICATION RATE
            Dosage Can Not be Calculated
            No Calculation can be made
            PPM calculated by weight
            PPM Calculated by volume
            Unknown whether PPM is given by weight or by volume
            Hundred Weight
            nn times  (10 power -xx); for instance,  "1.234E-04" is equivalent to ". 0001234''
  USE LIMITATIONS CODES
  CIS :  Do not discharge effluent containing this pesticide into sewage systems without notifying the sewage treatment plant authority.
  C24 :  Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public water.   (NPDES  license  restriction)
  C46 :  Do not apply through any type of irrigation system.
  GO3 :  Do not graze livestock in treated areas.
                                                                                           137

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                         )   Time 16:52
                                                             APPENDIX A
USE LIMITATIONS CODES (Cont.)
GO4 :  Do not graze livestock in treated orchards.
G61 :  Do not apply where fish are considered commercial resources.
G62 :  Do not apply where shellfish are considered commercial resources.
HOI :     day(s) preharvest interval.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS,  ETC.)  DESCRIBED IN THE LIMITATION.

GEOGRAPHIC CODES
CA  :  California
                                                                                         138

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                                GUIDE TO APPENDIX B

Appendix B  contains listings of data requirements which  support the reregi strati on for active
ingredients within the case Dichlobenil covered by this Reregi strati on Eligibility Decision Document.
It  contains generic data requirements that apply to Dichlobenil in all products, including data
requirements  for which a "typical formulation" is the test substance.

       The data table is organized in the following format:

       1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR Part 158.  the reference numbers accompanying each test refer to the test protocols
set in the Pesticide  Assessment Guidelines,  which are available from the  National  Technical
Information Service,  5285 Port Royal Road, Springfield, VA 22161 (703) 605-6000.

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

                            A     Terrestrial food
                            B     Terrestrial feed
                            C     Terrestrial non-food
                            D     Aquatic food
                            E     Aquatic non-food outdoor
                            F     Aquatic non-food industrial
                            G     Aquatic non-food residential
                            H     Greenhouse food
                            I      Greenhouse non-food
                            J      Forestry
                            K     Residential
                            L     Indoor food
                            M     Indoor non-food
                            N     Indoor medical
                            O     Indoor residential

       3.  Bibliographic citation (Column 3).   If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record Identification
(MRID) number, but may be a "GS" number if no MRID number has been assigned.  Refer to the
Bibliography  appendix for a complete citation of the study.
                                           139

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140

-------
                                        APPENDIX B
            Data Supporting Guideline Requirements for the Reregistration of Dichlobenil
REQUIREMENT
                                               USE PATTERN
              CITATION(S)
PRODUCT CHEMISTRY
61-1        Chemical Identity
61-2A      Start. Mat. & Mnfg. Process
61-2B      Formation of Impurities
62-1        Preliminary Analysis
62-2        Certification of limits
62-3        Analytical Method
63-2        Color
63-3        Physical State
63-4        Odor
63-5        Melting Point
63-6        Boiling Point
63-7        Density
63-8        Solubility
63-9        Vapor Pressure
63-10      Dissociation Constant
63-11      Octanol/Water Partition
63-12      pH
63-13      Stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL

ALL
ALL
ALL
ALL
ALL
ALL
ALL
42452401, 43140101, CSF 7/18/96
42452401, 43140101
42452401, 43140101
42452402, 43498601
42452401, CSF 7/18/96
42452402
42452403
42452403
42452403
42452403
N/A
42452403
40600605
40600607
NoMRID
40600608
42452403
42452403, 42452404, 43140102, 43916001
DATA GAP (Waiver Pending)
                                                  141

-------
             Data Supporting Guideline Requirements for the Reregistration of Dichlobenil
REQUIREMENT
                                                 USE PATTERN
                 CITATION(S)
63-14      Oxidizing/Reducing Action
63-16      Explodability
63-17      Storage stability
63-20      Corrosion characteristics
ECOLOGICAL EFFECTS
71-1A      Acute Avian Oral - Quail/Duck
71-2A      Avian Dietary - Quail
71-2B      Avian Dietary - Duck
71-4A      Avian Reproduction - Quail
71-4B      Avian Reproduction - Duck
72-1A      Fish Toxicity Bluegill
72-1C      Fish Toxicity Rainbow Trout
72-2A      Invertebrate Toxicity
72-2B      Invertebrate Toxicity - TEP
72-3A      Estuarine/Marine Toxicity - Fish
72-3B      Estuarine/Marine Toxicity -
           Mollusk
72-3C      Estuarine/Marine Toxicity - Shrimp
72-4A      Early Life Stage Fish
72-4B      Life Cycle Invertebrate
72-7A      Simulated Field - Aquatic
           Organisms
   ALL
   ALL
   ALL
   ALL

ABDGH
ABDGH
ABDGH
 ABGH
 ABGH
ABDGH
ABDGH
ABDGH
ABDGH
   CD
   CD

   CD
   CD
   CD
    D
43753901
43753902
43140103
DATA GAP

00160000, 40600601, 43469801
00022923, 40600603
00022923, 40600602
DATA GAP
DATA GAP
40098001
40098001, 43846901
05001497, 40775001
40094602
40228401, 43905403
40228401, 43905404

40228401, 43905405
00156312, 40825101, 42224202
00156312, 40775002, 42224201
N/A  0013752 (supplemental)
                                                    142

-------
Data Supporting Guideline Requirements for the Reregistration of Dichlobenil
REQUIREMENT
122-1A
122-1B
122-2
123-1A
123-1B
123-2
141-1
TOXICOI
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-1B
82-2
83-1A
Seed Germination/Seedling
Emergence
Vegetative Vigor
Aquatic Plant Growth
Seed Germination/Seedling
Emergence
Vegetative Vigor
Aquatic Plant Growth
Honey Bee Acute Contact
.OGY
Acute Oral Toxicity - Rat
Acute Dermal Toxicity - Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
90-Day Feeding - Rodent
90-Day Feeding - Hamster
21-Day Dermal - Rabbit/Rat
Chronic Feeding Toxicity - Rodent
USE PATTERN
BDG
BDG
BDG
BDG
BDG
BDG


ALL
ALL
ALL
ALL
ALL
ALL
AE
AE
ALL
AE
CITATION(S)
WAIVED
WAIVED
WAIVED
41280801, ADDENDUM
WAIVED
41280801
00156312, 40228401, 40758201, 40758202,
40758203, 40758204, 40758205
00018842

00112500
43250401
43335703
40425403
40425402
40548501
00107106
40600701
43879301
00147438, 40823801
                                  143

-------
             Data Supporting Guideline Requirements for the Reregistration of Dichlobenil
REQUIREMENT
                                                USE PATTERN
                CITATION(S)
83-1B      Chronic Feeding Toxicity -                   A E
           Non-Rodent
83-2A      Oncogenicity - Rat                          A E
83-2B      Oncogenicity - Hamster                     A E
83-3A      Developmental Toxicity - Rat                 A E
83-3B      Developmental Toxicity - Rabbit              A E
83-4        2-Generation Reproduction - Rat             A E
84-2A      Gene Mutation (Ames Test)                  ALL
84-2B      Structural Chromosomal                    ALL
           Aberration
84-4        Other Genotoxic Effects                     ALL
85-1        General Metabolism                        A E

OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1A     Foliar Residue Dissipation
132-1B     Soil Residue Dissipation
133-3       Dermal Passive Dosimetry Exposure
133-4       Inhalation Passive Dosimetry
           Exposure
231        Estimation of Dermal Exposure at
           Outdoor Sites
232        Estimation of Inhalation Exposure
           at Outdoor Sites
ABDG
ABDG
ABDG
ABDG

 ABD

 ABD
00067649, 43969701

00147438, 40823801, 40401101
41988301,42015101, 42221201, 42563601
00147437
41257302
41257303, 42239101
00153579, 00153576, 00153586
0015377, 41319101

00153580, 00153581
41227401, 41227402, 41227403, 41227404,
41299401

DATA GAP
DATA GAP
DATA GAP
DATA GAP

DATA GAP

DATA GAP
                                                   144

-------
             Data Supporting Guideline Requirements for the Reregistration of Dichlobenil
REQUIREMENT
                                                  USE PATTERN
                 CITATION(S)
ENVIRONMENTAL FATE
161-1      Hydrolysis
161-2      Photodegradation - Water
161-3      Photodegradation - Soil
162-1      Aerobic Soil Metabolism
162-3      Anaerobic Aquatic Metabolism
162-4      Aerobic Aquatic Metabolism
163-1      Leaching/Adsorption/Desorption

163-2      Volatility - Lab
163-3      Volatility - Field
164-1      Terrestrial Field Dissipation

164-2      Aquatic Field Dissipation
164-3      Forest Field Dissipation
165-4      Bioaccumulation in Fish
165-5      Bioaccumulation - Aquatic
           NonTarget
166-1      Ground Water - Small Prospective
167-1      Drinking Water Monitoring
201-1      Droplet Size Spectrum
202-1      Drift Field Evaluation
   ALL
 ABDG
    A
ABEGH
   DG
    D
   ALL

    A

  ABH

    D
    G
  ABD
   DG

    G
ABDGH
40548502
41709801
41119001, 43006801
41340601, 43006803
41306001
41149501
00049725, 00151561, 40600604, 41709802,
43006800, 43611101
43754001
Waived
41149502, 41170801, 41280802, 41385601,
43006800
41780601, 41877301, 42191401
DATA GAP
40465801, 40465802
41877301, 41780601

DATA GAP
DATA GAP
Waived
Waived
                                                     145

-------
            Data Supporting Guideline Requirements for the Reregistration of Dichlobenil
REQUIREMENT
RESIDUE
171-4A
171-4B
171-4C
171-4D
171-4E
CHEMISTRY
Nature of Residue - Plants
Nature of Residue - Livestock
Residue Analytical Method - Plants
Residue Analytical Method -
Animal
Storage Stability
USE PATTERN CITATION(S)

A 00113758, 00137791, 41531601, 41631501
A 00067651, 00111219, 00113741, 41012201,
41012202, 41301101,
43361201, 43361202, 43361203, 43361204
A 00109109, 00113739, 00113757, 00113759,
42026308, 42384801, 42729301, 42739601
A 00042489, 00042490, 00042491, 00067652
A 42026301, 42026302, 42026303, 42026304,
42026305, 42026306, 42026307, 42177101,
42177102, 42304201, 42432601, 42432602,
42452801, 42452802, 42452803, 42452804,
42476101, 42476102, 42476103, 42679001,
171-4J      Magnitude of Residues -
           Meat/Milk/Poultry/Egg
171-4K     Crop Field Trials
           Pome Fruits Group -

           - Apples
           - Pears
           Stone Fruits Group
           - Cherries
A
                                                                43184201
DATA GAP
A
A

A
00109109, 00113790, 42177102, 42452802
00109109

00113773, DAT A GAP
                                                  146

-------
             Data Supporting Guideline Requirements for the Reregistration of Dichlobenil
REQUIREMENT
                                                USE PATTERN
                                                       CITATION(S)
171-4L
Small Fruits and Berries Group
- Blackberries
- Blueberries
- Cranberries

- Grapes
- Raspberries
Tree Nuts Group
- Filberts
Processed Food
- Apples
- Grapes
A
A
A

A
A

A

A
A
00113768, 42026301, 42452803
00109109, 42026302, 42304201
00109109, 00113778, 00113782, 00113790,
00113799, 42026303, 42452801
00113768, 00113790, 42177101, 42476103
00113768, 42026307

00113739, 42026304, 42476101

42432601, 43184201
42432602
                                                   147

-------
                                       APPENDIX B
             Data Supporting Guideline Requirements for 2,6 Dichlorobenzamide (BAM)
REQUIREMENT
                                              USE PATTERN
                CITATION(S)
PRODUCT CHEMISTRY
63-8        Solubility
63-9        Vapor Pressure
ECOLOGICAL EFFECTS
72-1A      Fish Toxicity Bluegill
72-1C      Fish Toxicity Rainbow Trout
72-2A      Invertebrate Toxicity
72-4A      Early Life Stage Fish
123-2       Aquatic Plant Growth
ABDGH
ABDGH

ABDGH
ABDGH
ABDGH

  BDG
DATA GAP
DATA GAP

40098001
00156312, 40098001
00156312 (supplemental)
00156312 (supplemental)
00156312 (supplemental)
TOXICOLOGY
81-1        Acute Oral Toxicity - Mouse
81-2        Acute Dermal Toxicity - Rabbit/Rat
82-1A      90-Day Feeding - Rodent
83-1A      Chronic Feeding Toxicity - Rodent
83-1B      Chronic Feeding Toxicity
           Non-Rodent
ALL
ALL
AE
AE
42940201
00111402
00067654
00147438,
   AE
00147438, 40401101, 40823801, 42940202,
43747100, 44052901, 44043601
DATA GAP
00066983, 42940203,43747100
DATA GAP
                                                 148

-------
             Data Supporting Guideline Requirements for 2,6 Dichlorobenzamide (BAM)
REQUIREMENT
                                               USE PATTERN
                                                                CITATION(S)
83-2A      Oncogenicity - Rat

83-3B      Developmental Toxicity - Rabbit
83-4        3-Generation Reproduction - Rat
                                                   AE

                                                   AE
                                                   AE
84-2A      Gene Mutation (Ames Test)                 A E
84-4        Other Genotoxic Effects                    A E
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1B     Soil Residue Dissipation
ENVIRONMENTAL FATE
161-2       Photodegradation - Water
           Aerobic Soil Metabolism
           Aerobic Aquatic Metabolism
162-1
162-4
163-1
167-1
Leaching/Adsorption
/Desorption
Drinking Water Monitoring
 ABDG

 ABDG
ABEGH
    D
   ALL

ABDGH
                                                     00147438, 40401101, 40823801, 42940202,
                                                     43747100, 44052901, 44043601
                                                      DATA GAP
                                                     43003601, 43265201
                                                     (42940204-not acceptable, but there is no data
                                                     gap)
                                                     43003603
                                                     43003602, 43003604, 43747101
DATA GAP

DATA GAP
DATA GAP
DATA GAP
DATA GAP

DATA GAP
RESIDUE CHEMISTRY
171-4A     Nature of Residue - Plants
171-4B     Nature of Residue - Livestock
                                                    A
                                                    A
                                                     00113758, 00137791, 41531601, 41631501
                                                     00067651, 00111219, 00113741, 41012201,
                                                     41012202,41301101,
                                                     43361201, 43361202, 43361203, 43361204
                                                  149

-------
              Data Supporting Guideline Requirements for 2,6 Dichlorobenzamide (BAM)
REQUIREMENT
                                                 USE PATTERN
             CITATION(S)
171-4C     Residue Analytical Method - Plants
171-4D     Residue Analytical Method -
           Animal
171-4E     Storage Stability
A

A

A
00109109, 00113739, 00113757, 00113759,
42026308, 42384801, 42729301, 42739601
00042489, 00042490, 00042491, 00067652
42026301, 42026302, 42026303, 42026304,
42026305, 42026306, 42026307, 42177101,
42177102, 42304201, 42432601, 42432602,
42452801, 42452802, 42452803, 42452804,
42476101, 42476102, 42476103, 42679001,
43184201
171-4J     Magnitude of Residues -
           Meat/Milk/Poultry/Egg
171-4K     Crop Field Trials
           Pome Fruits Group -

           - Apples
            - Pears
           Stone Fruits Group
            - Cherries
           Small Fruits and Berries Group
            - Blackberries
           - Blueberries
           - Cranberries
A
DATA GAP
A
A

A

A
A
A
00109109, 00113790, 42177102, 42452802
00109109

00113773, DAT A GAP

00113768, 42026301, 42452803
00109109, 42026302, 42304201
00109109, 00113778, 00113782, 00113790,
00113799, 42026303, 42452801
                                                    150

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             Data Supporting Guideline Requirements for 2,6 Dichlorobenzamide (BAM)
REQUIREMENT
                                              USE PATTERN
                                                     CITATION(S)
171-4L
- Grapes
- Raspberries
Tree Nuts Group
- Filberts
Processed Food
- Apples
- Grapes
A
A

A

A
A
00113768, 00113790, 42177101, 42476103
00113768, 42026307

00113739, 42026304, 42476101

42432601, 43184201
42432602
                                                 151

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                                GUIDE TO APPENDIX C

1.      CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
       considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in
       the Reregistration Eligibility Document. Primary sources for studies in this bibliography
       have been the body of data submitted to EPA and its predecessor agencies in support of
       past regulatory decisions. Selections from other sources including the published literature,
       in those instances where they have been considered, are included.

2.      UNITS OF ENTRY.  The unit of entry in this bibliography is called a "study".  In the case
       of published materials, this corresponds closely to an article. In the case of unpublished
       materials submitted to the Agency, the Agency has  sought to identify documents at a level
       parallel to the published article from within the typically larger volumes in which they were
       submitted. The resulting "studies" generally have a distinct title (or at least a single
       subject), can stand alone for purposes of review and can be described with a conventional
       bibliographic citation. The Agency has also attempted to unite basic documents and
       commentaries upon them, treating them as a single  study.

3.      IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically
       by Master Record Identifier, or "MRID number". This number is unique to the citation,
       and should be used whenever a specific reference is required.  It is not related to the six-
       digit "Accession Number" which has been used to identify volumes of submitted studies
       (see paragraph 4(d)(4) below for further explanation).  In a few cases, entries added to the
       bibliography late in the review may be preceded by a nine character temporary identifier.
       These entries are listed after all MRID entries.  This temporary identifying number is also
       to be used whenever specific reference  is needed.

4.      FORM OF ENTRY.  In  addition to the Master Record Identifier (MRID), each entry
       consists of a citation containing standard elements followed, in the case of material
       submitted to EPA, by a description of the earliest known submission. Bibliographic
       conventions used reflect the standard of the American National Standards Institute
       (ANSI), expanded to  provide for certain special needs.

       a      Author. Whenever the author could confidently be  identified, the Agency has
              chosen to show a personal author.  When  no individual was identified, the Agency
              has shown an  identifiable laboratory or testing facility as the author.  When no
              author or laboratory could be identified, the Agency has shown the first submitter
              as the author.

       b.     Document date.  The date of the study is taken directly from the document. When
              the date is followed by a question mark, the bibliographer has deduced the date
              from the evidence contained in the document. When the date appears as (19??),
              the Agency was unable to determine or estimate the date of the document.
                                           152

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c.      Title.  In some cases, it has been necessary for the Agency bibliographers to create
       or enhance a document title. Any such editorial insertions are contained between
       square brackets.

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

       (1)     Submission date.  The date of the earliest known submission appears
              immediately following the word "received."

       (2)     Administrative number.  The next element immediately following the word
              "under" is the registration number, experimental use permit number,
              petition number, or other administrative number associated with the earliest
              known submission.

       (3)     Submitter.  The third element is the submitter. When authorship is
              defaulted to the submitter, this element is omitted.

       (4)     Volume Identification (Accession Numbers).  The final element in the
              trailing parentheses identifies the EPA accession number of the volume in
              which the original submission of the study appears.  The six-digit accession
              number follows the symbol "CDL," which stands for "Company Data
              Library." This accession number is in turn followed by an alphabetic suffix
              which shows the relative position of the study within the volume.
                                    153

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                                BIBLIOGRAPHY

MRID                         CITATION
00036253  Phipps, F.E. (1966) Analytical Method for the Determination of
      Dichlobenil Residues in Alfalfa. Includes method no. A-48 dated
      Dec 1, 1965.  (Unpublished study including data found in
      091620-H, received Nov 23, 1969 under OF0951; submitted by
      Thompson-Hay ward Chemical Co., Kansas City, Kans.; CDL:091620-C)

00036255  Rouppet, J. (1966) Analytical Method for the Determination of
      Dichlobenil Residues in Clover. Includes method no. A-91 dated
      Jul 25, 1966.  (Unpublished study received Nov 23, 1969 under
      OF0951; submitted by Thompson-Hay ward Chemical Co., Kansas City,
      Kans.; CDL:091620-E)

00036258  Perry, B.; Palmer, D.; Hill, B.; et al. (1969) Analytical Method
      for the Determination of Dichlobenil Residues in Alfalfa Hay.
      Includes method no. A-246 dated Oct 23, 1969.  (Unpublished
      study including data found in 091620-C, received Nov 23, 1969
      under OF0951; submitted by Thompson-Hayward Chemical Co., Kansas
      City, Kans.; CDL:091620-H)

00042489  Thompson-Hayward Chemical Company (1972) Analytical Method for the
      Determination of 2,6-Dichlorobenzamide Residue in Fish. Method
      no. A-320 dated Nov 21, 1972. (Unpublished study received on
      unknown date under IF 1074; CDL:091844-D)

00042490  Thompson-Hayward Chemical Company (19??) Clean-Up for the Residue
      Determination of 2,6-Dichloro-3-hydroxybenzonitrile (3-OH-di-
      chlobenil) in Fish Samples. Undated method no. A-321.  (Unpub-
      lished study received Jun 18, 1971 under 1F1074; CDL:091844-E)

00042491  Thompson-Hayward Chemical Company (19??) Gas Chromatographic Deter-
      mination of 2,6-Dichloro-3-hydroxy benzonitrile (3-OH-dichlo-
      benil) Residues in Pre-cleaned Samples.  Undated method no.
      A-322.  (Unpublished study received Jun 18, 1971 under 1F1074;
      CDL:091844-F)

00066983  Van Esch, G.J.; Verschuuren, H.G.  (19??) Investigation as to the
      Toxicity of H 133 Including a Chronic Experiment with Rats:
      Report No. 54/64 Tox. (Netherlands, Rijks Instituut voor de
      Volksgezondheid; unpublished study, including letter dated Dec
      3, 1965 from G.J. Van Esch to O. Garth Fitzhugh; CDL:091847-B)

00067649  Til, H.P.; Feron, V.J.; Huismans, J.W.; et al.  (1969) Chronic
      (Two-year) Toxicity Study with Dichlobenin (H 133) in Beagle

                                         154

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                                BIBLIOGRAPHY

MRID                         CITATION
     Dogs: Report No. R 2813. (Unpublished study received Jun 16,
     1971 under IF 1074; prepared by Central Instituut Voor Voeding-
     sonderzoek, submitted by Thompson-Hay ward Chemical Co., Kansas
     City, Mo.; CDL:091847-C)

00067651 Wit, J.G.; Van Genderen, H. (1966) Metabolism of the herbicide
     2,6-dichlorobenzonitrile in rabbits and rats.  Biochemical
     Journal 101:698-706. (Also~In~unpublished submission received
     Jun 16, 1971 under 1F1074; submitted by Thompson-Hayward Chem-
     ical Co., Kansas City, Kans.; CDL:091847-E)

00067652 Thompson-Hayward Chemical Company (1970) Analytical Method for
     the Determination of 2,6-Dichlorobenzamide Residues in Fish.
     Method no. A-267 dated Jul 10, 1970. (Unpublished study re-
     ceived Jun 16, 1971 under 1F1074, CDL:091847-G)

00109109 Thompson-Hayward Chemical Co. (1966) [Residues of Casoron in Cran-
     berries].  (Compilation; unpublished study received Jun 16, 1966
     under 6F0500; CDL:090578-A; 090579; 090580; 090581; 090577)

00112500 International Bio-Research, Inc. (1962) Acute Toxicity Study on
     Rats for Casoron.  (Unpublished study received Oct 1, 1963
     under 6F0500; submitted by Thompson-Hayward Chemical Co.,
     Kansas City, KS; CDL:090576-B)

00113739 Upton, E. (1969) Dichlobenil and 2,6-Dichlorobenzoic Acid Residue
     Analysis  of Filberts, Pecans, Walnuts, Almonds and Almond Hulls:
     Report No. R-741. (Unpublished study received Oct 7, 1969 under
     9F0837; submitted by Thompson-Hayward  Chemical Co., Kansas City,
     KS; CDL:091444-A)

00113740 Meulemans, K. (1970) Supplementary  Dichlobenil and 2,6-Dichloro-
     benzoic Acid Residue Analysis of Almond Nuts and Hulls: Report
     No. R-779. (Unpublished study received Jan 16, 1970 under
     9F0837; submitted by Thompson-Hayward  Chemical Co., Kansas City,
     KS; CDL:091445-A)

00113741 Houtman, A.; Bolhuis, L. (1967) C14 Contents of Milk and Some
     Tissues of Dairy Cattle  Given Drinking Water Containing Dichlo-
     benil C14: Report No. 56646/11/67-56639/9/67.  (Unpublished
     study received Oct 8, 1969 under 9F0837; prepared by N.V.
     Philips-Duphar, Neth., submitted by Thompson-Hayward Chemical
     Co., Kansas City, KS; CDL:091445-B)

                                        155

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                                BIBLIOGRAPHY

MRID                         CITATION
00113757 Thompson-Hayward Chemical Co. (1967) [Study: Dichlobenil Residue in
     Fish, Soil, Water, and Crops].  (Compilation; unpublished study
     received Nov 14, 1966 under 6F0500; CDL:092786-A)

00113758 Pate, D.; Funderburk, H. (19??) Absorption, translocation, and
     metabolism of 14C-labelled dichlobenil. Pages 17-26, In Iso-
     topes in Weed Research.  International Atomic Energy Agency:
     Vienna, Austria. (SM-69/2; also In unpublished submission re-
     ceived Nov 17, 1966 under 6F0500; submitted by Thompson-Hayward
     Chemical Co., Kansas City, KS; CDL:092786-B)

00113759 Thompson-Hayward Chemical Co. (1967) [Study: Dichlobenil Residue in
     Fish, Soil, Water, and Crops].  (Compilation; unpublished study
     received Feb 23, 1967; Feb 24, 1967 under 6G0502; CDL:092788-A)

00113767 Thompson-Hayward Chemical Co. (1966) Dichlobenil and 2,6-Dichloro-
     benzoic Acid: Residue Analysis of Citrus Fruit: Report No. R-
     608. (Compilation; unpublished study received Feb 10, 1966
     under 148-614; CDL:101181-A; 101167; 101169;  101168)

00113768 Thompson-Hayward Chemical Co. (1966) Dichlobenil and 2,6-Dichloro-
     benzoic Acid: Residue Analysis of Small Fruits: Report No. R-
     613. (Compilation; unpublished study received Mar 17, 1966
     under 148-614; CDL:101178-A; 101179)

00113771 Thompson-Hayward Chemical Co. (1964) [Residues of Casoron in
     Peaches].  (Compilation; unpublished study received on unknown
     date under 148-615; CDL:120091-A)

00113772 Thompson-Hayward Chemical Co. (1964) [Residues of Casoron in
     Prunes].  (Compilation; unpublished study received on unknown
     date under 148-615; CDL:120092-A)

00113773 Thompson-Hayward Chemical Co. (1964) [Residues of Casoron in
     Cherries]. (Compilation; unpublished study received on unknown
     date under 148-615; CDL:120093-A)

00113778 Thompson-Hayward Chemical Co. (1963) Data Supplementing Application
     for Registration of Casoron for Use in Cranberries.  (Compila-
     tion; unpublished study received Jan 18, 1963 under unknown
     admin, no.; CDL:120099-A)
                                        156

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                                BIBLIOGRAPHY

MRID                         CITATION
00113782  Upton, E. (1963) The Determination of 2,6-Dichlorobenzoic Acid
     Residues as a Possible Metabolite of Casoron in Cranberries:
     Report No. R-401.  (Unpublished study received Nov 1, 1963 under
     unknown admin, no.; submitted by Thompson-Hayward Chemical Co.,
     Kansas City, KS; CDL:120103-A)

00113790  Thompson-Hayward Chemical Co. (1962) [Determination of Casoron
     Residues in Various Crops].  (Compilation; unpublished study re-
     ceived on unknown date under 148-EX-2; CDL:122636-A)

00113791  Thompson-Hayward Chemical Co. (1962) [Efficacy of Casoron to Con-
     trol Weeds on Cranberry]. (Compilation; unpublished study re-
     ceived Mar 1, 1962 under 148-EX-2; CDL:122637-B)

00113799  Upton, E. (1963) The Determination of Casoron and 2,6-Dichloro-
     benzoic Acid Residues in Cranberries: Report No. R-251.  (Un-
     published study  received Jan 4, 1963 under unknown admin, no.;
     submitted by Thompson-Hayward Chemical Co., Kansas City, KS;
     CDL:223797-A)

 00147437 Koeter, H.  (1984) Oral Embryotoxicity/Teratogenicity Study with
      Dichlobenil in Rats: Final Report: Report No. V 84.026/231045.
      Unpublished study prepared by Netherlands Organization for Ap-
      plied Scientific  Research. 109 p.

00147438  Inoue, H. (1983) Chronic Feeding Study on Casoron in the Rat: Re-
     port No. 314. Unpublished study prepared by Biosafety Research
     Center, Foods, Drugs and Pesticides. Incomplete study, refer
      to MRID 40401101.  2728 p.

00151561  Willems, A.; Groeneveld, A.; Joustra, K. (1985) The Mobility of
     Dichlobenil in Four Soils: Report No. 56635/15/85.  Unpublished
     study prepared by Duphar B. V.  26 p.

00153576  Richold, M.; Edgar, D.;  Ransome, S.; et al (1984) The Mutagenic
     Potential of Dichlobenil Technical in vitro Mouse Lymphoma
     L5178Y Cell Mutation Test: Report No. PDR 381/831001: 56645/61/
     83.  Unpublished study prepared by Huntingdon Research Centre
     pic.  30 p.

00153577  Allen, I; Hales, 1; Brooker, P; et al (1984) Test on Mutagenic
     Potential of Dichlobenil in vitro Study of Metaphase Chromosomes
     of Human Lymphocytes:  Report No. PDR 380/83977: 56645/59/83.

                                         157

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                                 BIBLIOGRAPHY

MRID                          CITATION
      Unpublished study prepared by Huntingdon Research Centre pic.
      19 P.

00153579  Seket, J. (1983) Ames Test to Assess the Potential Mutagenic Effect
      of Dichlobenil: Int. Doc. No. 56645/58/83. Unpublished study
      prepared by DupharB.V. 21 p.

00153580  Allen, J.; Proudlock, R. (1984) Autoradiographic Assessment of DNA
      Repair in Mammalian Cells after Exposure to Dichlobenil Techni-
      cal: Report No. PDR 382/831065:  56645/60/83. Unpublished study
      prepared by Huntingdon Research  Centre pic. 20 p.

00153581  Matthews, E. (1984) Evaluation of Dichlobenil Technical in the in
      vitro Transformation of Balb/C-3T3 Cells with S9 Activation
      Assay: Final Report: Project No. 20992.  Unpublished study pre-
      pared by Litton Bionetics.  16 p.

00153586  Moriya, M.; Ohta, T.; Shirasu, Y. (1981) Report on the Results of
      DNB with Bacteria: Duphar Report No. 56645/22/82: Translated by
      Kali-Dupha, K.K. Unpublished study prepared by the Institute
      of Environmental Toxicology. 9 p.

05001497  Sanders, H.O. (1970) Toxicities of some herbicides to six species
      of freshwater crustaceans. Journal of the Water Pollution
      Control Federation 42(8): 1544-1550.

40401101  Kemp,  A.; Dawes, R. (1987) Chronic Feeding Study on Dichlobenil in
      the Rat: Addendum to Duphar Report No. 56645/41/84. Unpublished
      study prepared by Duphar B.V.  147 p.

40425403  Koopman, T. (1983) Primary Irritation Study of Dichlobenil Techni-
      cal to the Eye of the Male Rabbit: Laboratory Project ID: DT
      83/47: Int. Doc. No. 56645/38/83.  Unpublished study prepared by
      DupharB.V. 11 p.

40465801  Van Kampen, W.; Joustra, K.; Scherpenisse, P. (1987) The Identity
      of the [Carbon 14] Residues in Aquarium Water, Viscera and
      Fillet Samples of Bluegill Sunfish of ABC-laboratories, Biocon-
      centration Study #35168 with Dichlobenil: Laboratory Project ID
      C.201.62.001. Unpublished study  prepared by Duphar B.V.  39 p.

40465802  Forbis, A. (1986) Uptake, Depuration and Bioconcentration of
      [Carbon 14]-dichlobenil to Bluegill Sunfish (Lepomis macrochi-

                                         158

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                                 BIBLIOGRAPHY

MRID                          CITATION
      rus): ABC Laboratory Project ID Report #35168. Unpublished
      study prepared by Analytical Bio-Chemistry Laboratories, Inc.
      250 p.

40548501  Cuthbert, J.; Carr, S. (1987) Dichlobenil:  Magnusson-Kligman Maxi-
      misation Test in Guinea Pigs: Laboratory Project ID: 238368.
      Unpublished study prepared by Inveresk Research International.
      21 p.

40548502 Buisman, P. (1983) Stability and Solubility of Dichlobenil in
      Water: Laboratory Project ID: 82-4 AUV 82R008. Unpublished
      study prepared by Duphar B.V. 21 p.

40600601  Roberts, N.; Hakin, B. (1987) The Acute Oral Toxicity (LD50) of
      Dichlobenil to the Mallard Duck: PDR 474/871611. Unpublished
      study prepared by Huntingdon Research Centre Ltd.  24 p.

40600602  Roberts, N.; Hakin, B. (1987) The Dietary Toxicity (LC50) of Di-
      chlobenil to the Mallard Duck: PDR 475/871500. Unpublished stu-
      dy prepared by Huntingdon Research Centre Ltd. 18 p.

40600603  Roberts, N.; Hakin, B. (1987) The Dietary Toxicity (LC50) of Di-
      chlobenil to the Bobwhite Quail: PDR 476/871511.  Unpublished
      study prepared by Huntingdon Research Centre Ltd.  18 p.

40600604  Walstra, P.; Groeneveld, A.; Joustra, K.; et al. (1988) Adsorption/
      Desorption Studies on Dichlobenil in Various Soil Types:  Project
      ID: C.201.62.002.  Unpublished study prepared by Duphar B.V.
      Agrobiological Laboratory Boekesteyn.  25 p.

40600605  Van Berkel, M.; De Kok, H; Olthof, J. (1987) Physical and Chemical
      Characteristics of Dichlobenil: Project ID: C.201.20.003.  Un-
      published study prepared by Duphar B.V.  15 p.

40600607  Jager, H.; Harteveld, J. (1987) The Vapour Pressure of 2,6-Dichlo-
      robenzonitrile: Project ID: 132386156. Unpublished study pre-
      pared by Prins Maurits Laboratorium, TNO. 19 p.

40600608  Thus, J. (1984) Determination by HPLC of the Log P Value of Dichlo-
      benil and its Main Metabolite: Int. Doc. No. 56635/12/85. Un-
      published study prepared by Duphar B.V.  lip.
                                         159

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                                 BIBLIOGRAPHY

MRID                          CITATION
40600701  Kemp, A.; de Haan, M.; Jager, F. (1987) A 13-week Toxicity Study
      with Dichlobenil in Male and Female Hamster Followed by a 4-week
      Recovery Period: Laboratory Project ID DT 87/02: Int. Doc. No.
      56645/04/87. Unpublished study prepared by DupharB.V.  202 p.

40758201  Giddings, J. (1988) Toxicity of Dichlobenil to the Freshwater
      Green Alga: Laboratory Project ID 11493-0787-6107-550.  Unpub-
      lished study prepared by Springborn Life Sciences, Inc.  31  p.

40758202  Giddings, J. (1988) Toxicity of Dichlobenil to the Blue-green Alga:
      Anabaena flos-aguae: Laboratory Project ID 11493-0787-6107-550.
      Unpublished study prepared by Springborn Life Sciences, Inc.
      28 p.

40758203  Giddings, J. (1987) Toxicity of Dichlobenil to the Freshwater
      Plant: Lemna gibba G3: Laboratory Project ID  11493-0787-6108-
      550. Unpublished study prepared by  Springborn Life Sciences,
      Inc. 22 p.

40758204  Giddings, J. (1988) Toxicity of Dichlobenil to the Freshwater
      Diatom: Navicula pelliculosa: Laboratory Project  ID 11493-0787-
      6107-550. Unpublished study prepared by Springborn Life
      Sciences, Inc.  22 p.

40758205  Giddings, J. (1987) Toxicity of Dichlobenil to the Marine Diatom:
      Skeletonema costatum: Laboratory Project ID 11493-0787-6107-550.
      Unpublished study prepared by Springborn Life Sciences, Inc.
      22 p.

40775000  DupharB.V. (1988) Submission of Toxicity Data in Support of
      Dichlobenil Registration Standard.  Transmittal of 2 studies.

40775001  Burgess, D. (1987) Acute Flow-Through Toxicity of Dichlobenil to
      Daphnia magna: Project ID. 36180. Unpublished  study prepared by
      Analytical Bio-Chemical Laboratories, Inc.  24 p.

40775002  Forbis, A. (1988) Chronic Toxicity of Dichlobenil to Daphnia magna
      Under Flow-Through Test Conditions: Project ID 36181. Unpub-
      lished study prepared by Analytical Bio-Chemical Laboratories,
      Inc. 30 p.

40823801  Dijkstra, A. (1988) Chronic Feeding Study on Dichlobenil in the Rat
      (Duphar Report No. 56645/41/84): Addendum  2:  Project ID: Exp. No
                                          160

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                                 BIBLIOGRAPHY

MRID                          CITATION
      40 (010-002).  Unpublished study prepared by Biosafety Research
      Center. 60 p.

40825101  McAllister, W. (1988) Early Life Stage Toxicity of Dichlobenil to
      Rainbow Trout (Salmo gairdneri) in a Flow-through System: Final
      Report #36182. Unpublished study prepared by Analytical Bio-
      Chemistry Laboratories, Inc. 37 p.

41012101  Pouwelse, A.(1983) Stability and Solubility of Dichlobenil in Water
      Additional Data to Report 56630/207/87 (MRID No. 40548502):
      Project ID: 82-4 AUV 82R008. Unpublished study prepared by
      DupharB.V. 27 p.

41012200  Duphar B.V. (1989) Submission of Data To Support Registration of
      Dichlobenil: Residue Chemistry Data. Transmittal of 2 studies.

41012201  Cameron, B.;Dunshire,J. (1988) Disposition of (Carbon 14) Dichlo-
      benil in the Goat and Laying Hen: IRI Project Nos. 13685 and
      137142: Report No. 4558 5665/11/88. Unpublished  study prepared
      by Inveresk Research International. 55 p.

41012202  Ruijten, H.; Timmerman, B.; Vincent, W.; et al. (1988) The Charac-
      terization of Residues of (carbon 14) Dichlobenil in the Lacta-
      ting Goat and the Laying Hen: Project ID: C.201.63.004; AAA 88
      R016 t/m 027, 034. Unpublished study prepared by Duphar B.V.
      58 p.

41149501  Gohdes, M. (1989) Aerobic Aquatic Metabolism of [Carbon 14] Dichlo-
      benil: Final Report: Laboratory Project ID No. HLA 6015-360:
      Duphar Study No.  C.201.62.004.  Unpublished study prepared by
      Hazleton Laboratories America, Inc. 80 p.

41149502  El-Banna, S. (1989) Determination of Dichlobenil and 2,6-Dichloro-
      benzamide...A Field Dissipation Study: Final Report: Laboratory
      Project ID No. HLA 6012-181: Duphar Study No. C.201.60/001.
      Unpublished study prepared by Hazleton Laboratories America,
      Inc.  357 p.

41170801  El-Banna, S. (1989) Determination of Dichlobenil and 2,6-Dichloro-
      benzamide in Soil from a Field Dissipation Trial with Dichlo-
      benil in an Apple Orchard in Phelps, New York: Final Report:
      Laboratory Project ID HLA 6012-183. Unpublished study prepared
      by Hazleton Laboratories America, Inc. 374 p.

                                         161

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                                 BIBLIOGRAPHY

MRID                          CITATION
41227401  Koorn, E.; Kaldenberg, K.; Lange, N. (1989) Dichlobenil: Excretion
      in Rats After Oral and Intravenous Administration: Rept. No.
      56654/14/87. Unpublished study prepared by Duphar B.V.  21 p.

41227402  Kaldenberg, K.; Lange, N. (1989) Dichlobenil: Distribution in Rats
      After Oral Administration: Doc. No. 56654/02/88. Unpublished
      study prepared by Duphar B.V.  18 p.

41227403  Vincent, W.; Ruijten,H.; Van Eck, M.; et al. (1989) The Metabolism
      of Dichlobenil in the Rat: Doc. No. 56630/213/89. Unpublished
      study prepared by Duphar B.V. 71 p.

41227404  Lange, N. (1989) Summary on the Disposition Studies with Dichlo-
      benil in Rats: Doc. No. 56654/15/89. Unpublished study prepared
      by Duphar B.V. 16 p.

41257302  Barker, L. (1989) Dichlbenil: Oral (Gavage) Teratology Study in the
      Rabbit (Experiment II): Repeat Study: Laboratory Project ID
      5942-65/19: Duphar Report No. 56645/21/89. Unpublished study
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41257303  Leeming, N. (1989) Dichlobenil: 2 Generation Oral (Dietary
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41280801  Eussen, J. (1989) The Effect of Dichlobenil on Seed Germination,
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41280802  El-Banna, S. (1989) Determination of Dichlobenil and
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41299401  Cameron, B.;  Mutch, P.; Scott, G. (1989) The Excretion and
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41531601  Hubert, T. (1990) Dichlobenil: Nature of the Residue in Apples:
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41631501  Hubert, T. (1990) Dichlobenil: Nature of the Residue in Grapes: Lab
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41780601  Jacobson, B.; Judy, D.; Whithaus, M. (1991) Combined Aquatic Field
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                                         163

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42026301  Dykstra, A. (1991) Analysis of Blackberry Samples, From a Magnit-
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42026302  Dykstra, A. (1991) Analysis of Blueberry  Samples, From a Magnitude
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42026303  Dykstra, A. (1991) Analysis of Cranberry Samples, From Two Magnit-
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42026304  Dykstra, A. (1991) Analysis of Filbert Samples, From a Magnitude of
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                                         164

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42026306  Dykstra, A. (1991) Analysis of Peach Samples, From Two Magnitude of
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42026307  Dykstra, A. (1991) Analysis of Raspberry Samples, From Two Magnit-
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                                         165

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42452802  Ver Hey, M. (1992) Analysis of Apple Samples for Residues of
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42476101  Ver Hey, M. (1992) Analysis of Filbert Samples for Residues of
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42476102  Ver Hey, M. (1992) Analysis of Peach Samples for residues of
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42679001  Hamilton, B. (1993) Analysis of Plum and Prune Samples for
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                                         168

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43006800  Solvay Duphar B.V. (1993) Submission of Product Chemistry and
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43335703  Cracknell, S. (1994) Casoron W-85: Acute Inhalation Toxicity
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                                        173

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                   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                       WASHINGTON, D.C. 20460
                                                                            OFFICE OF
                                                                      PREVENTION, PESTICIDES
                                                                       AND TOXIC SUBSTANCES
                        GENERIC AND PRODUCT SPECIFIC
                               DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:

       This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment A of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your product(s)
containing this active ingredient. Within 90 days after you receive this Notice you must respond as
set forth in Section III below. Your response must state:

       1.     How you will comply with the requirements set forth in this Notice and its
             Attachments 1 through 6; or

       2.     Why you believe you are exempt from the requirements listed in this Notice and in
             Attachment 3 (for both generic and product specific data), the Requirements
              Status and Registrant's Response Form, (see section III-B);  or

       3.     Why you believe EPA should not require your submission of data in the manner
              specified by this Notice (see section III-D).

       If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2. All products are listed on both the generic
and product specific Data Call-In Response Forms.  Also included is a list  of all registrants who
were sent this Notice (Attachment 5).

       The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 1 U.S.C. section 136a(c)(2)(B). Collection of this
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information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 3-31-99).

       This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions.  The six sections of the Notice are:

Section I     -      Why You are Receiving this Notice
Section II    -      Data Required by this Notice
Section III   -      Compliance with Requirements of this Notice
Section IV   -      Consequences of Failure to Comply with this Notice
Section V    -      Registrants' Obligation to Report Possible Unreasonable Adverse Effects
Section VI   -      Inquiries and Responses to this Notice

       The Attachments to this Notice are:

       1 -    Data Call-In Chemical Status Sheet
       2 -    Generic Data Call-In and Product Specific Data Call-In Response Forms with
             Instructions (Form A)
       3 -    Generic Data Call-In and Product Specific Data Call-In Requirements Status and
             Registrant's Response Forms with Instructions (Form B)
       4 -    EPA Batching of End-Use Products for Meeting Acute Toxicology Data
             Requirements for Reregi strati on
       5 -    List of Registrants Receiving This Notice
       6 -    Cost Share and Data Compensation Forms
SECTION I.  WHY YOU ARE RECEIVING THIS NOTICE

       The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This reevaluation
identified additional data necessary to assess the health and safety of the continued use of
products containing this active ingredient(s). You have been sent this Notice because you have
product(s) containing the subject active ingredient(s).
SECTION II.  DATA REQUIRED BY THIS NOTICE

II-A.   DATA REQUIRED

       The data required by this Notice are specified in the Requirements Status and Registrant's
Response Forms: Attachment 3 (for both generic and product specific data requirements).
Depending on the results of the studies  required in this Notice, additional studies/testing may be
required.
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II-B. SCHEDULE FOR SUBMISSION OF DATA

       You are required to submit the data or otherwise satisfy the data requirements specified in
the Requirements Status and Registrant's Response Forms (Attachment 3) within the timeframes
provided.

II-C. TESTING PROTOCOL

       All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.

       These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, VA  22161 (Telephone number:
703-487-4650).

       Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40  CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate  so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 2001 L Street, N.W.,
Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone number 202-785-
0350).

       All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160].

II-D.   REGISTRANTS RECEIVING PREVIOUS  SECTION 3(c)(2)(B) NOTICES ISSUED
       BY THE AGENCY

       Unless otherwise noted herein, this Data Call-In does not in any way supersede or change
the requirements of any previous Data Call-In(s). or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to  avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III.       COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

       You must use the correct forms and instructions when completing your response to this
Notice. The type of Data Call-In you must comply with (Generic or Product Specific) is specified
in item number 3 on the four Data Call-In forms (Attachments 2 and 3).

III-A.  SCHEDULE FOR RESPONDING TO THE AGENCY

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       The appropriate responses initially required by this Notice for generic and product specific
data must be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance of
NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.

III-B.  OPTIONS FOR RESPONDING TO THE AGENCY

       1. Generic Data Requirements

       The options for responding to this Notice for generic data requirements are: (a) voluntary
cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to satisfy the generic
data requirements imposed by this Notice or (e) request a data waiver(s).

       A discussion of how to respond if you choose the Voluntary Cancellation option, the
Delete Use(s) option or the  Generic Data Exemption option is presented below. A discussion of
the various options available for satisfying the generic data requirements of this Notice is
contained in Section III-C. A discussion of options relating to requests for data waivers is
contained in Section III-D.

       Two forms apply to generic data requirements, one or both of which  must be used in
responding to the Agency, depending upon your response. These two forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form, (contained in
Attachments 2 and 3, respectively).

       The Data Call-In Response Forms must be submitted as part of every response to this
Notice. The Requirements Status and Registrant's Response Forms also must be submitted if you
do not qualify for a Generic Data Exemption or are not requesting voluntary cancellation of your
registration(s). Please note that the company's authorized representative is required to sign the
first page of both Data Call-In Response Forms and the Requirements Status and Registrant's
Response Forms (if this form is required) and initial any  subsequent pages. The forms contain
separate detailed instructions on the response options. Do not alter the printed  material. If you
have questions or need assistance in preparing your response, call or write the  contact person(s)
identified in Attachment 1.

       a.      Voluntary Cancellation  -

       You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the active ingredient that is the subject of this Notice. If you wish to
voluntarily cancel your product, you must submit completed Generic and Product Specific Data
Call-In Response Forms (Attachment 2), indicating your election of this option. Voluntary
cancellation is item number 5 on both Data Call-In Response Formfs). If you choose this option,
these are the only forms that you are required to complete.
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       If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.

       b.      Use Deletion -

       You may avoid the requirements of this Notice by eliminating the uses of your product to
which the requirements apply. If you wish to amend your registration to delete uses, you must
submit the Requirements Status and Registrant's Response Form (Attachment 3), a completed
application for amendment, a copy of your proposed amended labeling, and all other information
required for processing the application. Use deletion is option number 7 under item 9 in the
instructions for the Requirements Status and Registrant's Response Forms. You must  also
complete a Data Call-In Response Form by signing the certification, item number 8. Application
forms for amending registrations may be obtained from the Registration Support Branch,
Registration Division, Office of Pesticide Programs, EPA, by calling (703) 308-8358.

       If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale,  distribution, or use of your product after one year from  the due date of
your 90 day response, is allowed only if the product bears an amended label.

       c.      Generic Data Exemption -

       Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is  exempt
from the requirement to submit or cite generic data concerning an active ingredient if the active
ingredient in the product is derived exclusively from purchased, registered pesticide products
containing the  active  ingredient. EPA has concluded, as an exercise of its discretion, that it
normally will not suspend the registration of a product which would qualify and continue to
qualify for the  generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify,  all of the
following requirements must be met:

       (i).  The active ingredient in your registered product must be present solely because of
       incorporation of another registered product which contains the subject active ingredient
       and is purchased from a source not connected with you;
       (ii). Every registrant who is the ultimate source of the active ingredient in your product
       subject to this DCI must be in compliance with the requirements of this Notice and must
       remain in compliance; and

       (iii). You must have provided to EPA an accurate and current "Confidential Statement of
       Formula" for each of your products to which this Notice applies.

       To apply for the Generic Data Exemption you must submit a completed Data Call-In
Response Form. Attachment 2 and all supporting documentation. The Generic Data Exemption is
item number 6a on the Data Call-In Response Form. If you claim a generic data exemption you

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are not required to complete the Requirements Status and Registrant's Response Form. Generic
Data Exemption cannot be selected as an option for responding to product specific data
requirements.

       If you are granted a Generic Data Exemption, you rely on the efforts of other persons to
provide the Agency with the required data. If the registrant(s) who have committed to generate
and submit the required data fail to take appropriate steps to meet requirements or are no longer
in compliance with this Data Call-In Notice, the Agency will consider that both they and you are
not compliance and will normally initiate proceedings to suspend the registrations of both your
and their product(s), unless you commit to submit and do submit the required data within the
specified time. In such cases the Agency generally will not grant a time extension for submitting
the data.

       d.      Satisfying the Generic Data Requirements of this Notice

       There are various options available to satisfy the generic data requirements of this Notice.
These options are discussed in Section III-C.l. of this Notice and comprise options 1 through 6 of
item 9 in the instructions for the Requirements Status and Registrant's Response Form and item
6b on the Data Call-In Response Form.  If you choose item 6b (agree to satisfy the generic data
requirements),  you must submit the Data Call-In Response Form and the Requirements Status and
Registrant's Response Form as well as any other information/data pertaining to the option chosen
to address the data requirement. Your response must be on the forms marked "GENERIC" in
item number 3.

       e.      Request for Generic Data Waivers.

       Waivers for generic data are discussed in  Section III-D.l. of this Notice and are covered
by options 8 and 9 of item 9 in the instructions for the Requirements Status and Registrant's
Response Form. If you choose one of these options, you must submit both forms as well as any
other information/data pertaining to the  option chosen to address the data requirement.

       2. Product Specific Data Requirements

       The options for responding to this Notice for product specific data are:  (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this Notice or
(c) request a data waiver(s).

       A discussion of how to respond if you choose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C.2. A discussion of options relating
to requests for data waivers is contained in Section III-D.2.

       Two forms apply to the product specific data requirements one or both of which must be
used in responding to the Agency, depending upon your response. These forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form, for

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product specific data (contained in Attachments 2 and 3, respectively).  The Data Call-In
Response Form must be submitted as part of every response to this Notice.  In addition, one copy
of the Requirements Status and Registrant's Response Form also must be submitted for each
product listed on the Data Call-In Response Form unless the voluntary cancellation option is
selected. Please note that the company's authorized representative is required to sign the first
page of the Data Call-In Response Form and Requirements Status and Registrant's Response
Form (if this form is required) and initial any subsequent pages. The forms contain separate
detailed instructions on the response options. Do not alter the printed material. If you have
questions or need assistance  in preparing your response, call or write the contact person(s)
identified in Attachment 1.

       a.      Voluntary Cancellation

       You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the  active ingredient that is the subject of this Notice. If you wish to
voluntarily cancel your product, you must submit a completed Data Call-In Response Form.
indicating your election of this  option. Voluntary cancellation is item number 5 on both the
Generic and Product Specific Data Call-In Response Forms. If you choose this option, you must
complete both Data Call-In response forms. These are the only forms that you are required to
complete.

       If you choose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.

       b.      Satisfying the Product Specific Data Requirements of this Notice.

       There are various options available to satisfy the product specific data requirements of this
Notice. These options are discussed  in Section III-C. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the product specific Requirements Status and
Registrant's Response Form  and item numbers 7a and 7b (agree to satisfy the product specific
data requirements for an MUP  or EUP as applicable) on the product specific Data Call-In
Response Form. Note that the options available for addressing product specific data requirements
differ slightly from those options for fulfilling generic data requirements. Deletion of a use(s) and
the  low volume/minor use option are not valid options for fulfilling product  specific data
requirements. It is important to ensure that you are using the correct forms and instructions when
completing your response to  the Reregi strati on Eligibility Decision document.

       c.      Request for Product Specific Data Waivers.

       Waivers for product specific data are discussed in Section III-D.2. of this Notice and are
covered by option 7 of item 9 in the  instructions for the Requirements Status and Registrant's
Response Form. If you choose this option, you must submit the Data Call-In Response Form and
the  Requirements Status and Registrant's Response Form as well as any other information/data
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pertaining to the option chosen to address the data requirement. Your response must be on the
forms marked "PRODUCT SPECIFIC" in item number 3.

III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

       1.     Generic Data

       If you acknowledge on the Generic Data Call-In Response Form that you agree to satisfy
the generic data requirements (i.e. you select item number 6b), then you must select one of the six
options on the Generic Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item number
9, "Registrant Response." The six options related to data  production are the first six options
discussed under item 9 in the instructions for completing  the Requirements Status and Registrant's
Response Form. These six options are listed immediately  below with information in parentheses to
guide you to additional instructions provided in this Section. The options are:

       (1)    I will generate and submit data within the specified timeframe (Developing Data)
       (2)    I have entered into an agreement with one or more registrants to develop data
             jointly (Cost Sharing)
       (3)    I have made offers to cost-share (Offers to Cost Share)
       (4)    I am submitting an existing study that has  not been submitted previously to the
             Agency by anyone (Submitting an Existing Study)
       (5)    I am submitting or citing data to upgrade a study classified by EPA as partially
             acceptable and upgradeable (Upgrading a  Study)
       (6)    I am citing an existing study that EPA has  classified as acceptable or an existing
             study that has been submitted but not reviewed by the Agency (Citing an Existing
             Study)

Option 1. Developing Data

       If you choose to develop the required data it must be in conformance with Agency
guidelines and with other Agency requirements as referenced herein and in the attachments. All
data generated and submitted must comply with the Good Laboratory Practice (GLP) rule (40
CFR Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG) and be in
conformance with the requirements of PR Notice 86-5. In addition, certain studies require Agency
approval of test protocols in advance of study initiation. Those studies for which a protocol must
be submitted have been identified in the Requirements Status and Registrant's Response Form
and/or footnotes to the form. If you wish to use a protocol which differs from the  options
discussed in Section II-C of this Notice, you must submit a  detailed description of the proposed
protocol and your reason for wishing to use it. The Agency may choose to reject a protocol not
specified in Section II-C. If the Agency rejects your protocol you will be notified in writing,
however, you should be aware that rejection of a proposed protocol will not be a basis for
extending the deadline for submission of data.
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       A progress report must be submitted for each study within 90 days from the date you are
required to commit to generate or undertake some other means to address that study requirement,
such as making an offer to cost share or agreeing to share in the cost of developing that study.
This 90-day progress report must include the date the study was or will be initiated and, for
studies to be started within 12 months of commitment, the name and address of the
laboratory(ies) or individuals who are or will be conducting the study.

       In addition, if the time frame for submission of a final report is more than 1 year, interim
reports must be submitted at 12 month intervals from the date you are required to commit to
generate or otherwise address the requirement for the study. In addition to the other information
specified in the preceding paragraph, at a minimum, a brief description of current activity on and
the status of the study must be included as well as a full description of any problems encountered
since the last progress report.
       The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports or protocols.
The noted deadlines run from the date of the receipt of this Notice by the registrant. If the data
are not submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to
Suspend the affected registration(s).

       If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the  expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request,  the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your request,
the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions will
not be given in submitting the 90-day responses. Extensions will not be considered if the request
for extension is not made in a timely fashion; in no event shall an extension request be considered
if it is submitted at or after the lapse  of the subject deadline.

Option 2. Agreement to Share in Cost to Develop Data

       If you choose to enter into an agreement to share in the cost of producing the required
data but will not be submitting the data yourself, you must provide the name of the registrant who
will be submitting the  data. You must also provide EPA  with documentary evidence that an
agreement has been formed. Such evidence may be your letter offering to join in an agreement and
the other registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The  agreement to produce the data  need not specify all of the terms of the final
arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides that if the parties cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.

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Option 3. Offer to Share in the Cost of Data Development
       If you have made an offer to pay in an attempt to enter into an agreement or amend an
existing agreement to meet the requirements of this Notice and have been unsuccessful, you may
request EPA (by selecting this option) to exercise its discretion not to suspend your
regi strati on(s), although you did not comply with the data submission requirements of this Notice.
EPA has determined that as a general policy, absent other relevant considerations, it will not
suspend the registration of a product of a registrant who has in good faith sought and continues to
seek to enter into a joint data development/cost sharing program, but the other registrant(s)
developing the data has refused to accept the offer. To qualify for this option, you must submit
documentation to the Agency  proving that you have made an offer to another registrant (who has
an obligation to submit data) to share in the burden of developing that data. You must also submit
to the Agency a completed EPA Form 8570-32, Certification of Offer to Cost Share in the
Development of Data, Attachment 6.  In addition, you must demonstrate that the other registrant
to whom the offer was made has not accepted your offer to enter into a cost-sharing agreement by
including a copy of your offer and proof of the other registrant's receipt  of that offer (such as a
certified mail receipt). Your offer must, in addition to anything else, offer to share in the burden of
producing the data upon terms to be agreed to or, failing agreement, to be bound by binding
arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify this offer. The other
registrant must also inform EPA of its election of an option to develop and submit the data
required by this Notice by submitting  a Data Call-In Response Form and a Requirements Status
and Registrant's Response Form committing to develop and submit the data required by this
Notice.

       In order for you to avoid suspension under this option, you may  not withdraw your offer
to share in the burden of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
to develop the data or for some other  reason is subject to suspension, your registration as well as
that of the other registrant normally will be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit, the required data in the specified time frame. In such cases,
the Agency generally will not  grant a time extension for submitting the data.

Option 4. Submitting an Existing Study

       If you choose to submit an existing study in response to this Notice, you must determine
that the study satisfies the requirements imposed by this Notice. You may only submit a study that
has not been previously submitted  to the Agency or previously cited by anyone. Existing studies
are studies which predate issuance of this Notice. Do not use this option if you are submitting
data to upgrade a study. (See Option  5).

       You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission. The Agency may  determine at any time that a study is not valid and needs to
be repeated.

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       To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:

       a.      You must certify at the time that the existing study is submitted that the raw data
              and specimens from the study are available for audit and review and you must
              identify where they are available.  This must be done in accordance with the
              requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part
              160. As stated in 40 CFR 160.3, Raw data means any laboratory worksheets,
              records, memoranda, notes, or exact copies thereof, that are the result of original
              observations and activities of a study and are necessary for the reconstruction and
              evaluation of the report of that study. In the event that exact transcripts of raw
              data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
              and verified accurate by signature), the exact copy or exact transcript may be
              substituted for the original source as raw data.  'Raw data' may include
              photographs, microfilm or microfiche copies, computer printouts, magnetic media,
              including dictated observations, and recorded data from automated instruments."
              The term "specimens", according  to 40 CFR 160.3, means "any material derived
              from a test system for examination or analysis."

       b.      Health and safety studies completed after May 1984 must also contain all
              GLP-required quality assurance and  quality control information pursuant to the
              requirements of 40 CFR Part 160. Registrants also must certify at the time of
              submission of the existing study that such GLP information is available for post
              May 1984 studies by including an appropriate  statement on or attached to the
              study  signed by an authorized official or representative  of the registrant.

       c.      You must certify that each study fulfills the acceptance  criteria for the Guideline
              relevant to the study provided in the FIFRA Accelerated Reregi strati on Phase 3
              Technical Guidance and that the study has been conducted according to the
              Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
              documents available from NTIS). A study not  conducted according to the PAG
              may be submitted to the Agency for consideration if the registrant believes that the
              study  clearly meets the purpose of the PAG. The registrant is referred to 40 CFR
              158.70 which states the Agency's policy regarding acceptable protocols. If you
              wish to submit the study, you must, in addition to certifying that the purposes of
              the PAG  are met by the study, clearly articulate the rationale why you believe the
              study  meets the purpose of the PAG, including copies of any supporting
              information or data.  It has been the Agency's experience that studies completed
              prior to January 1970 rarely satisfied the purpose of the PAG and that necessary
              raw data usually are not available for such studies.

       If you submit an  existing study, you must certify that the study  meets all requirements of
the criteria outlined above.
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       If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were addressed in the
final protocol and study.

       If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined  above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such a study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.

Option 5. Upgrading a Study

       If a study has been classified as partially acceptable and upgradeable, you may submit data
to upgrade that study.  The Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still be
required to submit new data normally without any time extension. Deficient, but upgradeable
studies will normally be classified as supplemental. However, it is important to note that  not all
studies classified as  supplemental are upgradeable. If you have questions regarding the
classification of a study or whether a study may be upgraded, call or write the contact person
listed in Attachment 1. If you submit data to upgrade an existing study you must satisfy or supply
information to correct all deficiencies in the study identified by EPA. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or corrected and why the study
should be rated as acceptable to EPA. Your submission must also specify the MRID number(s) of
the study which you are attempting to upgrade and must be in conformance with PR Notice 86-5.

       Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.

       This option also should be used to cite data that has been previously submitted to upgrade
a study, but has not  yet been reviewed  by the Agency. You must provide the MRID number of the
data submission as well as the MRID number of the study being upgraded.

       The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally, your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria, as well as a certification regarding protocol compliance with Agency requirements.

Option 6. Citing Existing  Studies

       If you choose to cite a study that has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable, or it must be a study which has not yet been
reviewed by the Agency. Acceptable toxicology studies generally will have been classified as
"core-guideline" or "core-minimum." For ecological effects studies, the classification generally
would be a rating of "core." For all  other disciplines the classification would be "acceptable." With

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respect to any studies for which you wish to select this option, you must provide the MRID
number of the study you are citing and, if the study has been reviewed by the Agency, you must
provide the Agency's classification of the study.

       If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.

       2. Product Specific Data

       If you acknowledge on the product specific Data Call-In Response Form that you agree to
satisfy the product specific data requirements (i.e. you select option 7a or 7b), then you must
select one of the six options on the Requirements Status and Registrant's Response Form related
to data production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options  discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form.  These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions provided in this Section. The options
are:

       (1)    I will generate and submit data within the specified time-frame (Developing Data)
       (2)    I have entered into an agreement with one or more registrants to develop data
             jointly (Cost Sharing)
       (3)    I have made offers to cost-share (Offers to Cost Share)
       (4)    I am  submitting an existing study that has not been submitted previously to the
             Agency by anyone (Submitting an Existing Study)
       (5)    I am  submitting or citing data to upgrade a study classified by EPA as partially
             acceptable and upgradeable (Upgrading a Study)
       (6)    I am  citing an existing study that EPA has classified as acceptable or an existing
             study that has been submitted but not reviewed by the Agency (Citing an Existing
             Study)

Option  1. Developing Data — The requirements for developing product specific data are the same
as those described for generic data (see Section III.C.l, Option 1) except that normally no
protocols or progress reports are  required.

Option 2. Agree to Share in Cost to Develop Data — If you enter into an agreement to cost share,
the same requirements apply to product specific data as to generic data (see Section III.C.l,
Option 2). However, registrants may only choose this option for acute toxicity data and certain
efficacy data and only if EPA has indicated in the attached data tables that your product and at
least one other product are similar for purposes of depending on the same data. If this is the case,
data may be generated for just one of the products in the group. The registration number of the
product for which data will be submitted must be noted in the agreement to cost share by the
registrant selecting this option.
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Option 3. Offer to Share in the Cost of Data Development —The same requirements for generic
data (Section III.C.L, Option 3) apply to this option. This option only applies to acute toxicity
and certain efficacy data as described in option 2 above.

Option 4. Submitting an Existing Study - The same requirements described for generic data (see
Section III.C.l., Option 4) apply to this option for product specific data.

Option 5. Upgrading a Study - The same requirements described for generic data (see Section
III.C.l., Option 5) apply to this option for product specific data.

Option 6. Citing Existing Studies - The same requirements described for generic data (see
Section III.C.l., Option 6) apply to this option for product specific data.

       Registrants who select one  of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (III.C.l.), as appropriate.
III-D REQUESTS FOR DATA WAIVERS

       1.      Generic Data

       There are two types of data waiver responses to this Notice. The first is a request for a
low volume/minor use waiver and the second is a waiver request based on your belief that the
data requirement(s) are not appropriate for your product.

       a.      Low Volume/Minor Use Waiver

              Option 8 under item 9 on the Requirements Status and Registrant's Response
       Form. Section 3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness of
       requiring data for low volume/minor use pesticides. In implementing this provision, EPA
       considers low volume pesticides to be only those active ingredients whose total
       production volume for all pesticide registrants is small. In determining whether to grant a
       low volume, minor use waiver, the Agency will consider the extent, pattern and volume of
       use, the economic incentive to conduct the testing, the importance of the pesticide,  and the
       exposure and risk from use of the pesticide. If an active ingredient is used for both high
       volume and low volume uses, a low volume exemption will not be approved. If all uses  of
       an active ingredient are low volume and the combined volumes for all uses are also low,
       then an exemption may be granted, depending on review of other information outlined
       below. An exemption will not be granted if any registrant of the active ingredient elects to
       conduct the testing. Any registrant receiving a low volume/minor use waiver must remain
       within the sales figures in their forecast supporting the waiver request in order to remain
       qualified for such waiver. If granted a waiver,  a registrant will be required, as a condition
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       of the waiver, to submit annual sales reports. The Agency will respond to requests for
       waivers in writing.

       To apply for a low volume/minor use waiver, you must submit the following information,
as applicable to your product(s), as part of your 90-day response to this Notice:

              (i).  Total company sales (pounds and dollars) of all registered product(s)
       containing the active ingredient. If applicable to the active ingredient, include foreign sales
       for those products that are not registered in this country but are applied to sugar (cane or
       beet), coffee, bananas, cocoa, and other such crops. Present the above information by year
       for each of the past five years.

              (ii)  Provide an estimate of the sales (pounds and dollars) of the active ingredient
       for each major use site. Present the above information by year for each of the past five
       years.

              (iii) Total direct production cost of product(s) containing the active ingredient  by
       year for the past five years. Include information on raw material cost, direct labor cost,
       advertising, sales and marketing, and any other significant costs listed separately.

              (iv) Total indirect production  cost (e.g.  plant overhead, amortized plant and
       equipment) charged to product(s) containing the active ingredient by year for the past five
       years. Exclude all non-recurring costs that were directly related to the active ingredient,
       such as costs  of initial registration and any data  development.

              (v)  A list of each data requirement for which you seek a waiver. Indicate the type
       of waiver sought and the estimated cost to you (listed separately for each  data requirement
       and associated test) of conducting the  testing needed to fulfill each of these  data
       requirements.

              (vi) A list of each data requirement for which you are not seeking any waiver and
       the estimated cost to you (listed separately for each data requirement and associated test)
       of conducting the testing needed to fulfill each of these data requirements.

              (vii) For each of the next ten years, a year-by-year forecast of company sales
       (pounds and dollars) of the active ingredient, direct production costs of product(s)
       containing the active ingredient (following the parameters in item 2 above), indirect
       production costs of product(s) containing the active ingredient (following the parameters
       in item 3 above), and costs of data development pertaining to the active ingredient.

              (viii)  A description of the importance and unique benefits of the active ingredient
       to users. Discuss the use patterns and the effectiveness of the active  ingredient relative to
       registered alternative chemicals and non-chemical control strategies. Focus on benefits
       unique to the active ingredient, providing information that is as quantitative  as possible. If
       you do not have quantitative data upon which to base your estimates, then present the

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reasoning used to derive your estimates. To assist the Agency in determining the degree of
importance of the active ingredient in terms of its benefits, you should provide information
on any of the following factors, as applicable to your product(s): (a) documentation of the
usefulness of the active ingredient in Integrated Pest Management, (b) description of the
beneficial impacts on the environment of use of the active ingredient, as opposed to its
registered alternatives, (c) information on the breakdown of the active ingredient after use
and on its persistence in the environment, and (d) description of its usefulness against a
pest(s) of public health significance.

       Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume/minor use waiver will result in denial of the request
for a waiver.

b.      Request for Waiver of Data

       Option 9, under Item 9, on the Requirements Status and Registrant's Response
Form. This option may be used if you believe that a particular data requirement should not
apply because the requirement is inappropriate. You must submit a rationale explaining
why you believe the data requirements should not apply. You also must submit the current
label(s) of your product(s)  and, if a current copy of your Confidential Statement of
Formula is not already on file you must submit a current copy.

       You will be informed of the Agency's decision in writing. If the Agency determines
that the data requirements of this Notice are not appropriate to your product(s), you will
not be required to supply the data pursuant to section 3(c)(2)(B). If EPA determines that
the data are required for your products). you must choose a method of meeting the
requirements of this Notice within the time frame provided by this Notice. Within 30 days
of your receipt of the Agency's written decision, you must submit a revised Requirements
Status and Registrant's Response Form indicating the option chosen.

2. Product Specific Data

       If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request including technical
reasons, data and references to relevant EPA regulations, guidelines or policies.  (Note:
any supplemental data must be submitted in the format required by PR Notice 86-5). This
will be the only opportunity to state the reasons or provide information in support of your
request. If the Agency approves your waiver request, you will not be required to supply
the data pursuant to section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver
request, you must choose an option for meeting the data requirements of this Notice
within 30 days of the receipt of the Agency's decision. You must indicate and submit the
option chosen on the product specific Requirements Status and Registrant's Response
Form. Product specific data requirements for product chemistry, acute toxicity and
efficacy (where appropriate) are required for all products and the Agency would grant a
waiver only under extraordinary circumstances. You should also be aware that submitting

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       a waiver request will not automatically extend the due date for the study in question.
       Waiver requests submitted without adequate supporting rationale will be denied and the
       original due date will remain in force.
SECTION IV.       CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
                     NOTICE

IV-A  NOTICE OF INTENT TO SUSPEND

       The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
to failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:

       1.      Failure to respond as required by this Notice within 90 days of your receipt of this
              Notice.

       2.      Failure to submit on the required schedule an acceptable proposed or final protocol
              when such is required to be submitted to the Agency for review.

       3.      Failure to submit on the required schedule an adequate progress report on a study
              as required by this Notice.

       4.      Failure to submit on the required schedule acceptable data as required by this
              Notice.

       5.      Failure to take a required action or submit adequate information pertaining to any
              option chosen to address the data requirements (e.g., any required action or
              information pertaining to submission or citation of existing studies or offers,
              arrangements, or arbitration on the sharing of costs or the formation of Task
              Forces, failure to comply with the terms of an agreement or arbitration concerning
              joint data development or failure to comply with any terms of a data waiver).

       6.      Failure to submit supportable certifications as to the conditions of submitted
              studies, as required by Section III-C of this Notice.

       7.      Withdrawal of an offer to share in the cost of developing required data.

       8.      Failure of the registrant to whom you have tendered an offer to share in the  cost of
              developing data and provided proof of the registrant's receipt of such offer or
              failure of a registrant on whom you rely for a generic data exemption either  to:
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              a. Inform EPA of intent to develop and submit the data required by this Notice on
              a Data Call-In Response Form and a Requirements Status and Registrant's
              Response Form.

              b. Fulfill the commitment to develop and submit the data as required by this
              Notice; or

              c. Otherwise take appropriate steps to meet the requirements stated in this Notice,
              unless you commit to submit and do submit the required data in the specified time
              frame.

       9.      Failure to take any required or appropriate steps, not mentioned above,  at any time
              following the issuance of this Notice.

IV-B.  BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE

       The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:

       1)      EPA requirements specified in the Data Call-In Notice or other documents
       incorporated by reference (including, as applicable, EPA Pesticide Assessment Guidelines,
       Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the
       design, conduct, and reporting of required studies. Such requirements include, but are not
       limited to, those relating to test material, test procedures, selection of species, number of
       animals, sex and distribution of animals, dose and effect levels to be tested or attained,
       duration of test, and, as applicable, Good Laboratory Practices.

       2)      EPA requirements regarding the submission of protocols, including the
       incorporation of any changes required by the Agency following review.

       3)      EPA requirements regarding the reporting of data, including the manner of
       reporting, the completeness of results, and the adequacy of any required supporting (or
       raw) data, including, but not limited to, requirements referenced or included in this Notice
       or contained in PR 86-5. All studies must be submitted in the form of a final report; a
       preliminary report will not be considered to fulfill the submission requirement.

IV-C  EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS

       EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.

       The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding generally  would not

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be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You also must explain why an "existing stocks" provision is necessary, including a statement of
the quantity of existing stocks and your estimate of the time required for their sale, distribution,
and use. Unless you meet this burden, the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.

       If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency  requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution  or use of stocks of voluntarily
cancelled products containing an active ingredient for which the Agency has particular risk
concerns will be determined on a case-by-case basis.

       Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due, unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration six
months before a 3-year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
              UNREASONABLE ADVERSE EFFECTS

       Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
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SECTION VI.       INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.

       All responses to this Notice must include completed Data Call-In Response Forms
(Attachment 2)and completed Requirements Status and Registrant's Response Forms (Attachment
3), for both (generic and product specific data) and any other documents required by this Notice,
and should be submitted to the contact person(s) identified in Attachment 1. If the voluntary
cancellation or generic data exemption option is chosen, only the Generic and Product Specific
Data Call-In Response Forms need be submitted.

       The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance
(OECA), EPA, will be monitoring the data being generated in response to this Notice.

                                 Sincerely yours,
                                 Lois A. Rossi, Director
                                 Special Review and
                                  Reregi strati on Division
Attachments
       The Attachments to this Notice are:

       1 -    Data Call-In Chemical Status Sheet
       2 -    Generic Data Call-In and Product Specific Data Call-In Response Forms with
             Instructions
       3 -    Generic Data Call-In and Product Specific Data Call-In Requirements Status and
             Registrant's Response Forms with Instructions
       4 -    EPA Batching of End-Use Products for Meeting Acute Toxicology Data
             Requirements for Reregi strati on
       5 -    List of Registrants Receiving This Notice
       6 -    Confidential Statement of Formula. Cost Share and Data Compensation Forms
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DICHLOBENIL DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing Dichlobenil.

       This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and  point of contact for inquiries  pertaining to the reregi strati on of
Dichlobenil. This attachment is to be used in conjunction with (1) the Product Specific Data Call-In
Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the Requirements
Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use Products for Meeting
Acute Toxicology Data Requirement (Attachment 4), (5) the EPA Acceptance Criteria (Attachment
5),  (6) a list of registrants receiving this DCI (Attachment 6) and (7) the Cost Share  and Data
Compensation Forms in replying to this Dichlobenil Product Specific Data Call-In (Attachment 7).
Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

       The additional data requirements needed to complete the  database for Dichlobenil are
contained in the Requirements Status and Registrant's Response. Attachment 3.  The Agency has
concluded that additional data on Dichlobenil are needed for specific products. These data are
required to be submitted to the Agency within the time frame listed. These data are needed to fully
complete the reregi strati on of all eligible Dichlobenil products.

INQUIRIES AND RESPONSES TO THIS NOTICE
       If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Dana Lateulere at (703) 308-8044.

       All responses to this Notice for the Product Specific data requirements should be submitted
       to:
             Dana Lateulere
             Chemical Review Manager Team 81
             Product Reregi strati on Branch
             Special Review and Reregistration Branch 7508W
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C. 20460

             RE: Dichlobenil
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Dichlobenil DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You have been sent this Generic Data Call-In Notice because you have product(s) containing
Dichlobenil.

       This Generic Data Call-In Chemical Status Sheet, contains an overview of data required by
this notice, and point of contact for inquiries pertaining to the reregistration of Dichlobenil.  This
attachment is to be used in conjunction with (1) the Generic Data Call-In Notice, (2) the Generic Data
Call-In Response Form (Attachment 2), (3) the Requirements Status and Registrant's Form
(Attachment 2), (4) a list of registrants receiving this DCI (Attachment 4), (5) the EPA Acceptance
Criteria (Attachment 5), and (6) the Cost Share and Data Compensation Forms in replying to this
Dichlobenil Generic Data Call In (Attachment F).  Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE
       The additional data requirements needed to complete the generic database for Dichlobenil are
contained in the Requirements Status and Registrant's Response. Attachment C.  The Agency has
concluded that additional product chemistry data on Dichlobenil are needed. These data are needed
to fully complete the reregistration of all eligible Dichlobenil products.

INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the generic data requirements and procedures established
by this Notice, please contact Dana Lateulere at (703) 308-308-8044.

       All responsades to this Notice for the  generic data requirements should be submitted to:

             Dana Lateulere, Chemical Review Manager
             RB3
              Special Review and Registration Division (H7508W)
             Office of Pesticiafde Programs
             U.S. Environmental Protection Agency
             Washington, D.C. 20460
             RE:  Dichlobenil
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  Instructions For Completing The "Data Call-In Response Forms" For The Generic And
                              Product Specific Data Call-In
INTRODUCTION

These instructions apply to the Generic and Product Specific "Data Call-In Response Forms" and
are to be used by registrants to respond to generic and product specific Data Call-Ins as part of
EPA's Reregi strati on Program under the Federal Insecticide, Fungicide, and Rodenticide Act.   If
you are an end-use product registrant only and have been sent this DCI letter as part of a RED
document you have been sent just the product specific "Data Call-In Response Forms." Only
registrants responsible for generic data have been sent the generic data response form.  The type
of Data Call-In (generic or product specific) is indicated in item number 3 ("Date and Type
of DCI") on each form.
Although the form is the same for both generic and product specific data, instructions for
completing these forms are different.  Please read these instructions carefully before filling out the
forms.

EPA has developed these forms individually for each registrant, and has preprinted these forms
with a number of items. DO NOT use these forms for any other active ingredient.

Items 1 through 4 have been preprinted on the form.  Items 5 through 7 must be completed by the
registrant as  appropriate. Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.

The public reporting burden for this collection of information is estimated to average 15 minutes
per response, including time for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding the burden estimate or any other aspect of this  collection of
information,  including suggestions for reducing this burden, to Chief, Information Policy Branch,
Mail Code 2137, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, D.C.
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 1.       ON BOTH FORMS: This item identifies your company name, number and
             address.

Item 2.       ON BOTH FORMS: This item identifies the case number, case name, EPA
             chemical number and chemical name.

ItemS.       ON BOTH FORMS: This item identifies the type of Data Call-In.  The date of
             issuance is date stamped.

Item 4.       ON BOTH FORMS: This item identifies the EPA product registrations relevant
             to the data call-in. Please note that you are also responsible for informing the
             Agency of your response regarding any product that you believe may be covered
             by this Data Call-In but that is not listed by the Agency in Item 4. You must bring
             any such apparent omission to the Agency's attention within the period required
             for submission of this response form.

Item 5.       ON BOTH FORMS: Check this item for each product registration you wish to
             cancel voluntarily. If a registration number is listed for a product for which you
             previously requested  voluntary cancellation, indicate in Item 5 the date of that
             request. Since this Data Call-In requires both generic and product specific data,
             you must complete item 5 on both Data Call-In response forms. You do not need
             to complete any item on the Requirements Status and Registrant's Response
             Forms.

Item 6a.      ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for
             generic data as indicated in Item 3 and you are eligible for a Generic Data
             Exemption for the chemical listed in Item 2 and used in the subject product. By
             electing this exemption, you agree to the terms and conditions of a Generic Data
             Exemption as explained in the Data Call-In Notice.

             If you are eligible for or claim a Generic Data Exemption, enter the EPA
             registration Number of each registered source of that active ingredient that you use
             in your product.

             Typically, if you purchase an EPA-registered product from one or more other
             producers (who, with respect to the incorporated product, are in compliance with
             this and any other outstanding Data Call-In Notice), and incorporate that product
             into all your products, you may complete this item for all products listed on this
             form. If, however, you produce the active ingredient yourself, or use any
             unregistered product  (regardless of the fact that some  of your sources are
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             registered), you may not claim a Generic Data Exemption and you may not select
             this item.

INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 6b.      ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for
             generic data as indicated in Item 3 and if you are agreeing to satisfy the generic
             data requirements of this Data Call-In. Attach the Requirements Status and
             Registrant's Response Form that indicates how you will satisfy those requirements.

             NOTE:  Item 6a and 6b are not applicable for Product Specific Data.

Item 7a      ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing use
             product (MUP) for which you wish to maintain registration, you must agree to
             satisfy the data requirements by responding "yes."

Item 7b.      For each end use product (EUP) for which you wish to maintain registration, you
             must agree to satisfy the data requirements by responding "yes."

             FOR BOTH MUP and EUP products

             You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if
             your product is identical to another product and you qualify for a data exemption.
             You must provide the EPA registration numbers of your source(s); do not
             complete the Requirements Status and Registrant's Response form. Examples of
             such products include repackaged products and Special Local Needs (Section 24c)
             products which are identical to federally registered products.

             If you are requesting a data waiver, answer "yes" here; in addition, on the
             "Requirements Status and Registrant's Response" form under Item 9, you must
             respond with option 7 (Waiver Request) for each study for which you are
             requesting a waiver.

             NOTE:  Item 7a and 7b are not applicable for Generic Data.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 8.        ON BOTH FORMS: This certification statement must be signed by an
               authorized representative of your company and the person signing must include
               his/her title.  Additional pages used in your response must be initialled and dated in
               the space provided for the certification.

Item 9.        ON BOTH FORMS: Enter the date of signature.

Item 10.       ON BOTH FORMS: Enter the name of the person EPA should contact with
               questions regarding your response.

Item 11.       ON BOTH FORMS: Enter the phone number of your company contact.
 Note:     You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you may wish to
         report that your product has already been transferred to another company or that you have already voluntarily cancelled this product. For these cases, please
         supply all relevant details so that EPA can ensure that its records are correct.
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    Instructions For Completing The "Requirements Status and Registrant's Response
               Forms" For The Generic and Product Specific Data Call-In
INTRODUCTION

       These instructions apply to the Generic and Product Specific "Requirements Status and
Registrant's Response Forms" and are to be used by registrants to respond to generic and product
specific Data Call-in's as part of EPA's reregi strati on program under the Federal Insecticide,
Fungicide, and Rodenticide Act.   If you are an end-use product registrant only and have been
sent this DCI letter as part of a RED document you have been sent just the product specific
"Requirements Status and Registrant's Response Forms." Only registrants responsible for generic
data have been sent the generic data response forms.  The type of Data Call-In (generic or
product specific) is indicated in item number 3 ("Date and Type of DCI") on each form.

       Although the form is the same for both product specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for satisfying product specific data
requirements do not include (1) deletion of uses  or (2) request for a low volume/minor use
waiver. Please read these instructions carefully before filling out the forms.

       EPA has developed these forms individually for each registrant, and has preprinted these
forms to include certain information unique to this chemical. DO NOT use these forms for any
other active ingredient.

       Items 1 through 8  have been preprinted on the form.  Item 9 must be completed by the
registrant as appropriate.  Items 10 through 13 must be completed by the registrant before
submitting a response to the Agency.

       The public reporting burden for this collection of information is estimated to average 30
minutes per response, including time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments  regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, Mail Code 2137,  U.S. Environmental Protection Agency, 401 M St., S.W., Washington,
D.C. 20460; and to the Office of Management and Budget, Paperwork Reduction Project
2070-0107, Washington, D.C. 20503.
                                          201

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    INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
                       REGISTRANT'S RESPONSE FORMS"

Generic and Product Specific Data Call-In
Item 1.       ON BOTH FORMS:  This item identifies your company name, number and
             address.

Item 2.       ON THE GENERIC DATA FORM: This item identifies the case number, case
             name, EPA chemical number and chemical name.

             ON THE PRODUCT SPECIFIC DATA FORM:  This item identifies the case
             number, case name, and the EPA Registration Number of the product for which
             the Agency is requesting product specific data.

Item 3.       ON THE GENERIC DATA FORM: This item identifies the type of Data
             Call-In. The date of issuance is date stamped.

             ON THE PRODUCT SPECIFIC DATA FORM:  This item identifies the type
             of Data Call-In. The date of issuance is also date stamped.  Note the unique
             identifier number (ID#) assigned by the Agency. This ID number must be used in
             the transmittal document for any data submissions in response to this Data Call-In
             Notice.

Item 4.       ON BOTH FORMS:  This item identifies the guideline reference number of
             studies required.  These guidelines, in addition to the requirements specified in the
             Data Call-In Notice, govern the conduct of the required studies. Note that series
             61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
             158.180, Subpartc.

Item 5.       ON BOTH FORMS:  This item identifies the study title associated with the
             guideline reference number and whether protocols and 1, 2, or 3-year progress
             reports are required to be submitted in connection with the study. As noted in
             Section III of the Data Call-In Notice, 90-day progress reports are required for all
             studies.

             If an asterisk appears in Item 5, EPA has attached information relevant to this
             guideline reference number to the Requirements Status and Registrant's Response
             Form.
                                         202

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    INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
                        REGISTRANT'S RESPONSE FORMS"

Generic and Product Specific Data Call-In

Item 6.       ON BOTH FORMS: This item identifies the code associated with the use
             pattern of the pesticide.  In the case of efficacy data (product specific
             requirement), the required study only pertains to products which have the use sites
             and/or pests indicated. A brief description of each code follows:

             A     Terrestrial food
             B     Terrestrial feed
             C     Terrestrial non-food
             D     Aquatic food
             E     Aquatic non-food outdoor
             F     Aquatic non-food industrial
             G     Aquatic non-food residential
             H     Greenhouse food
             I      Greenhouse non-food crop
             J      Forestry
             K     Residential
             L     Indoor food
             M     Indoor non-food
             N     Indoor medical
             O     Indoor residential

Item 7.       ON BOTH FORMS: This item identifies the code assigned to the substance that
             must be used for testing. A brief description of each code follows:

             EUP                End-Use Product
             MP                 Manufacturing-Use Product
             MP/TGAI           Manufacturing-Use Product and Technical   Grade Active
                                 Ingredient
             PAI                 Pure Active Ingredient
             PAI/M              Pure Active Ingredient and Metabolites
             PAI/PAIRA         Pure Active Indredient or Pute Active
                                 Ingredient Radiolabelled
             PAIRA             Pure Active Ingredient Radiolabelled
             PAIRA/M           Pure Active Ingredient Radiolabelled and Metabolites
             PAIRA/PM         Pure Active Ingredient Radiolabelled and Plant Metabolites
             TEP                Typical End-Use Product
             TEP	%          Typical End-Use Product, Percent Active Ingredient
                                 Specified
             TEP/MET           Typical End-Use Product and Metabolites
                                         203

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             TEP/PAI/M          Typical End-Use Product or Pure Active Ingredient and
                                  Metabolites
             TGAI               Technical Grade Active Ingredient
             TGAI/PAI           Technical Grade Active Ingredient or Pure Active
                                  Ingredient
             TGAI/PAIRA        Technical Grade Active Ingredient or Pure Active
                                  Ingredient Radiolabelled
             TGAI/TEP           Technical Grade Active Ingredient or Typical End-Use
                                  Product
             MET                Metabolites
             IMP                 Impurities
             DEGR              Degradates
             *                    See: guideline comment

Item 8.       This item completed by the Agency identifies the time frame allowed for
             submission of the study or protocol identified in item 5.

             ON THE GENERIC DATA FORM: The time frame runs from the date of your
             receipt of the Data Call-In notice.

             ON THE PRODUCT SPECIFIC DATA FORM:  The due date for submission
             of product specific studies begins from the date stamped on the letter transmitting
             the Reregistration Eligibility Decision document, and not from the date of receipt.
             However, your response to the Data Call-In itself is due 90 days from the date of
             receipt.

Item 9.       ON BOTH FORMS: Enter the appropriate Response Code or Codes to show
             how you intend to comply with each data requirement. Brief descriptions of each
             code follow. The Data Call-In Notice contains a fuller description of each of these
             options.

       Option 1.     ON BOTH FORMS: (Developing Data^ I will conduct a new study and
                    submit it within the time frames specified in item 8 above. By indicating
                    that I have chosen this option, I certify that I will comply with all the
                    requirements pertaining to the conditions for submittal of this study as
                    outlined in the Data Call-In Notice and that I will provide the protocols and
                    progress reports required in item 5 above.

       Option 2.     ON BOTH FORMS: (Agreement to Cost Shared I have entered into an
                    agreement with one or more registrants to develop data jointly. By
                    indicating that I have chosen this option, I certify that I will comply with all
                    the requirements pertaining to sharing in the cost of developing data as
                    outlined in the Data Call-In Notice.
                                          204

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                     However, for Product Specific Data, I understand that this option
              is available for acute toxicity or certain efficacy data ONLY if the Agency
              indicates in an attachment to this notice that my product is similar enough
              to another product to qualify for this option. I certify that another party in
              the agreement is committing to submit or provide the required data; if the
              required study is not submitted on time, my product may be subject to
              suspension.

Option 3.      ON BOTH FORMS: fOffer to Cost Shared I have made an offer to enter
              into an agreement with one or more registrants to develop data jointly. I
              am also submitting a completed "Certification of offer to Cost Share in the
              Development of Data" form. I am submitting evidence that I have made an
              offer to another registrant (who has an obligation to submit data) to share
              in the cost of that data. I am including a copy of my offer and proof of the
              other registrant's receipt of that offer.  I am identifying the party which is
              committing to submit or provide the required data; if the required study is
              not submitted on time, my product may be subject to suspension. I
              understand that other terms under Option 3 in the Data Call-In Notice
              apply as well.

                     However, for Product Specific Data, I understand that this
              option is available only for acute toxicity or certain efficacy data and only if
              the Agency indicates in an attachment to this Data Call-In Notice that my
              product is similar enough to another product to qualify for this option.

Option 4.      ON BOTH FORMS: (Submitting Existing Data^  I will submit an
              existing study by the specified due date that has never before been
              submitted to EPA.  By indicating  that I have chosen this  option, I certify
              that this study meets all the requirements pertaining  to the conditions for
              submittal of existing data outlined in the Data Call-In Notice  and I have
              attached the needed supporting information along with this response.

Options.      ON BOTH FORMS: (Upgrading  a Study ^ I will submit by the specified
              due date, or will cite data to upgrade a study that EPA has classified as
              partially acceptable and potentially upgradeable.  By indicating that I have
              chosen this option,  I certify that I  have met all the requirements pertaining
              to the conditions for submitting or citing existing data to upgrade a study
              described in the Data Call-In Notice. I am  indicating on attached
              correspondence the Master Record Identification Number (MRID) that
              EPA has assigned to the data that I am citing as well as the MRID  of the
              study I am attempting to upgrade.

Option 6.      ON BOTH FORMS: fCiting a Study) I  am citing an existing study that
              has been previously classified by EPA as acceptable, core, core minimum,
                                    205

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             or a study that has not yet been reviewed by the Agency. If reviewed, I am
             providing the Agency's classification of the study.

                    However, for Product Specific Data, I am citing another
             registrant's study. I understand that this option is available ONLY for
             acute toxicity or certain efficacy data and ONLY if the cited study was
             conducted on my product, an identical product or a product which the
             Agency has "grouped" with one or more other products for purposes of
             depending on the same data. I may also choose this option if I am citing my
             own data. In either case, I will provide the MRID or Accession number (s).
             If I cite another registrant's data, I will submit a completed "Certification
             With Respect To Data Compensation Requirements" form.

FOR THE GENERIC DATA FORM ONLY:  The following three options (Numbers
7, 8, and 9) are responses that apply only to the "Requirements Status and
Registrant's Response Form" for generic data.

Option 7.     (Deleting Uses)  I am attaching an application for amendment to my
             registration deleting the uses for which the data are required.

Option 8.     (Low Volume/Minor Use Waiver Request) I have read the statements
             concerning low volume-minor use data waivers in the Data Call-In Notice
             and I request a low-volume minor use waiver of the data requirement. I am
             attaching a detailed justification to support this waiver request including,
             among other things, all information required to support the request. I
             understand that, unless modified by the Agency in writing, the data
             requirement as stated in the Notice governs.

Option 9.     (Request for Waiver of Data) I have read the statements concerning data
             waivers other than lowvolume minor-use data waivers in the Data Call-In
             Notice and I request a waiver of the data requirement. I am attaching a
             rationale explaining why I believe the data requirements do not apply. I am
             also submitting a copy of my current labels. (You must also submit a copy
             of your Confidential Statement of Formula if not already on file with EPA).
             I understand that, unless modified by the Agency in writing, the data
             requirement as stated in the Notice governs.

FOR PRODUCT SPECIFIC DATA:  The following option (number 7) is a response
that applies to the "Requirements Status and  Registrant's Response Form" for
product specific data.

Option 7.     (Waiver  Request) I request a waiver for this study because it is
             inappropriate for my product. I am attaching a complete justification for
             this request, including technical reasons,  data and references to relevant
             EPA regulations, guidelines or policies. [Note: any supplemental data must

                                   206

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                      be submitted in the format required by P.R. Notice 86-5]. I understand that
                      this is my only opportunity to state the reasons or provide information in
                      support of my request. If the Agency approves my waiver request, I will
                      not be required to supply the data pursuant to Section 3(c)  (2) (B) of
                      FIFRA. If the Agency denies my waiver request, I must choose a method
                      of meeting the data requirements of this Notice by the due date stated by
                      this Notice. In this case, I must, within 30 days-of my receipt of the
                      Agency's written decision,  submit a revised "Requirements  Status" form
                      specifying the option chosen. I also understand that the deadline for
                      submission of data as specified by the original Data Call-In  notice will not
                      change.

Item 10.      ON BOTH FORMS: This item must be signed by an authorized representative of
              your company. The person signing must include his/her title, and must initial and
              date all other pages of this form.

Item 11.      ON BOTH FORMS: Enter the date of signature.

Item 12.      ON BOTH FORMS: Enter the name of the person EPA should contact with
              questions regarding your response.

Item 13.      ON BOTH FORMS: Enter the phone number of your company contact.
    NOTE:    You may provide additional information that does not fit on this form in a signed letter that accompanies this your response. For example, you may
           wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this product. For these
                                             207

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 EPA'S BATCHING OF DICHLOBENIL PRODUCTS FOR MEETING REREGISTRATION
                       ACUTE TOXICITY DATA REQUIREMENTS

       In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of products containing dichlobenil 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 that the Agency is not describing batched products  as
"substantially similar" since some products within a batch may not be considered chemically similar
or have identical use patterns.
       Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwith-standing the batching process, the Agency reserves the right to require,
at  any time, acute toxicity data for an individual product should the need arise.
       Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute toxicological studies to represent all the products within that batch. It is
the registrant's option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required  acute
toxicological studies for each of their own products. If a registrant chooses to generate the data for
a batch, he/she must use one of the products within the batch as the test material.  If a registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the
data base  is  complete and valid by today's standards (see acceptance criteria attached), the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute toxicity data. Regardless  of
whether new data is generated or existing data is referenced, registrants must clearly identify the test
material by EPA Registration Number. If more than one confidential statement of formula (CSF)
exists for a product, the registrant must indicate the formulation actually tested by identifying the
corresponding CSF.
       In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice
contains two response forms which are to be completed and submitted to the Agency within 90 days
of receipt.  The first form, "Data Call-In Response," asks whether the registrant will meet the data
requirements for each product.  The second form, "Requirements Status and Registrant's Response,"
lists the product specific data required for each product, including the standard six acute toxicity tests.
A  registrant who wishes to participate in a batch  must decide whether he/she will provide the data
or depend on someone else to do so. If a registrant supplies the data to support a batch of products,
he/she must select one of the following options:  Developing Data (Option 1), Submitting an Existing
Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6).
If a registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers
to  Cost Share (Option 3) or Citing an Existing Study (Option 6).  If a registrant does not want  to
participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that
choosing not to participate in a batch does not preclude other registrants in the batch from citing
his/her studies and offering to cost share (Option 3) those studies.

                                           208

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       Thirty-three products were found which contain dichlobenil as an active ingredient. These
products have been placed into five batches and a "no batch" category in accordance with the active
and inert ingredients, type of formulation  and current labeling.  Acute  data are not needed for
products in batches 1, 2, 3, 4 and 5. These data requirements are satisfied by acute data performed
with the technical. For the products in batches 1, 2 and 3, the appropriate acute dermal and inhalation
categories will be extrapolated from the category II technical classification.  Furthermore, the five
sewer root control products (which contain dichlobenil and metam sodium) in the "no batch" category
do not need to submit acute data.  The appropriate precautionary labeling and hazard classifications
have recently been defined by the Agency for these products.
       Products 802-571. 11364-5 and 68464-1 are the only products which require a PCI.  A
complete acute  six pack is needed for each of these products to support reregistration.  Table 1
identifies the products in each batch. Table  2 lists the products which have been placed in the "no
batch" category.
       Table 1
Batch
1
EPA Reg. No.
400-168
400-170
802-536
802-570
2217-675
2217-678
2217-682
7401-395
10583-16
34704-720
34704-738
68153-1
CA89004600
OR95000300
WA95000600
% active ingredient
4.0
2.0
2.0
1.0
4.0
2.0
4.0
2.0
4.0
2.0
4.0
0.5
4.0
4.0
4.0
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
                                            209

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Batch
2
O
4
5
EPA Reg. No.
400-178
2217-679
400-169
2217-676
400-176
400-463
2217-677
400-175
400-462
2217-680
% active ingredient
10.0
10.0
50.0
50.0
85.0
85.0
85.0
98.0
99.0
99 5
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
       The following table lists products that were either considered not to be similar or the Agency
lacked sufficient information for decision making and were not placed in any batch. The registrants
of these products are responsible for meeting the acute toxicity data requirements separately or
through the accepted bridging scheme presented above.

       Table 2 (No Batch)
EPA Reg. No.
802-571
9993-2
9993-3
11364-5
64503-2
68464-1
% active ingredient
1.5
Dichlobenil 1.74
Metam sodium 28.4
Dichlobenil 1.96
Metam sodium 24.3
Dichlobenil 0.5
Sodium hydroxide 56.0
Dichlobenil 50.0
Metam sodium 32.7
0.55
Formulation
Type
Solid
Combination
Combination
Solid
Combination
Solid
                                           210

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EPA Reg. No.
64898-4
64945-3
% active ingredient
Dichlobenil 50.0
Metam sodium 32.7
Dichlobenil 85.0
Metam sodium 32.7
Formulation
Type
Combination
Combination
211

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212

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   List of All Registrants Sent This Data Call-In (Insert) Notice
(PLEASE REMOVE THIS PAGE AND INSERT MAILING LIST)
                          213

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214

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Instructions for Completing the Confidential Statement of Formula

The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies
of the form are required.  Following are basic instructions:

       a.     All the blocks on the form must be filled in and answered completely.

       b.     If any block is not applicable, mark it N/A.

       c.     The CSF must be signed, dated and the telephone number of the responsible party
             must be provided.

       d.     All applicable information which is on the product specific data submission must also
             be reported on the CSF.

       e.     All weights reported under item 7 must be in pounds per gallon for liquids and pounds
             per cubic feet for solids.

       f     Flashpoint must be in degrees Fahrenheit and flame extension in inches.

       g.     For all active ingredients, the EPA Registration Numbers for the currently registered
             source products must be reported under column 12.

       h.     The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
             common names for the trade names must be reported.

       i.     For the active ingredients, the percent purity of the source products must be reported
             under column 10 and must be exactly the same as on the source product's label.
       j.     All the weights in columns 13.a. and  13.b. must be in pounds, kilograms, or grams.
             In no case  will volumes be accepted. Do not mix English and metric system units (i.e.,
             pounds and kilograms).

       k.     All the items under column 13.b. must total 100 percent.

       1.     All items under columns 14.a. and 14.b. for the active ingredients must represent pure
             active form.

       m.    The upper and lower certified limits for ail active and inert ingredients must follow the
             40 CFR 158.175 instructions. An explanation must be provided if the proposed limits
             are different than standard certified limits.

       n.     When new CSFs are submitted and approved, all previously submitted CSFs become
             obsolete for that specific formulation.


                                          215

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216

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218

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                       United States Environmental Protection Agency
                                   Washington, D.C. 20460
                              Certification of Offer to Cost
                          Share in the Development of Data
                                                                                     Form Approved
                                                                                   OMB No. 2070-0106,
                                                                                       2070-0057
                                                                                    Approval Expires
                                                                                        3-31-99
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden to, Chief Information Policy
Branch, PM-233, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of
Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.

Please fill in blanks below:
Company Name
                                                                                  Company Number
Product Name
                                                                                  EPA Reg. No.
I Certify that:

My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.

My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
an offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firms on the following
date(s):
Name of Firm(s)
                                                                                  Date of Offer
Certification:

I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
                                                                                  Date
Name and Title (Please Type or Print)
                                                 219

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                                                         UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                                                              401 M Street, S.W.
                                                                          WASHINGTON, D.C. 20460
                                                                                                                                       Form Approved OMB No. 2070-0060
 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for
 reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of
 information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not
 send the form to this address.
                                                                           DATA MATRIX
 Date
EPA Reg No./File Symbol
                                                                                                                    Page   of
 Applicant's/Registrant's Name & Address
Product
 Ingredient
 Guideline Reference Number
                                                    Note
Guideline Study Name
EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version.
                                                     Public File Copy
                                                                                 220

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Form Approved OMB No. 2070-0060
/«T\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
l**Z/ 401 M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for
reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of
information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC
20460. Do not send the form to this address.
DATA MATRIX
Date
Applicant's/Registrant's Name & Address
EPA Reg No./File Symbol
Page of
Product
Ingredient
Guideline Reference Number















Guideline Study Name















MRID Number















Signature
Submitter















Status















Name and Title
Note















Date
EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version.
Agency Internal Use Copy
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                                                                 INSTRUCTIONS FOR DATA MATRIX
INSTRUCTIONS: Identify all data submitted or cited and all submitters from whom permission has been received or to whom offers to pay have been sent by entering sufficient information in
the attached matrix (photocopy and attach additional pages as necessary). Complete all columns; omission of essential information will delay approval of the registration/reregistration. On each
page enter the date, Applicant's/Registrant's name,  EPA Registration Number or application file symbol of the product, ingredient, page number, and total number of pages.

The Data Compensation Form entitled "Certification with Respect to Citation of Data" and the Data Matrix will be publicly available, except for the Guideline Reference Number, Guideline Study
Name, and MRID Number columns after the registration/reregistration of this product has been granted or once this form is  received in response to a Data-Call-in Notice. However, the information
in the Guideline Reference Number, Guideline Study Name, and MRID Number columns is available through the Freedom of Information Act in association with the EPA Registration Number.

Ingredient: Identify the active ingredient(s) in this product for which data are cited. The active ingredient(s) are to be identified by entering the chemical name and the CAS registry number.  Begin
a new page for each  separate active ingredient for which  data are cited.  If bridging data from a related chemical or representative test compound are cited, enter the identity of that
chemical/representative test compound including the EPA Registration Number/File Symbol if appropriate.

        If the cite-all method is used for all data supporting this particular ingredient, enter "CITE-ALL" in the Guideline Reference Number column and leave the Guideline Study Name column
blank. If the cite-all method is used for a particular Guideline Reference Number enter "CITE-ALL" in the MRID Number column on the line for that Guideline Reference  Number. In either case,
enter all submitters to whom offers to pay have been sent on subsequent lines. [Note:  if the selective method of support is used and written authorization (letter of permission) is provided, the
individual Guideline Reference Number, Guideline Study Name, and MRID Number columns must still be completed.]  Otherwise:

Guideline Reference Number: Enter on separate lines in numerical order the Guideline Reference Numbers from 40 CFR Part 158 for all studies cited to support the registration/reregistration
for this ingredient.

Guideline Study Name: For each Guideline Reference Number cited, enter the corresponding Guideline Study Name.

MRID Number:  For each individual study cited in support of a Guideline Reference Number and Guideline Study Name, enter the Master Record Identification (MRID) Number listed in the Pesticide
Document Management System (PDMS).  Enter only one  MRID  Number on each line.  Note that more than one MRID Number may be required per Guideline Reference Number.  Note:
Occasionally a study required to maintain a registration/reregistration  is not associated with a Guideline Reference Number and Guideline Study Name.  In such case, enter the MRID Number(s)
for the study(ies).

Submitter:  Using the most recent Data Submitters List, identify  the Original Data Submitter with their current address for each study cited.  The EPA assigned company number or other
abbreviation may be used.  Clearly explain any variations (alternate addresses, data owners not on the Data Submitters List, etc.) in footnotes to this table.

Status: Enter one of the following codes for each study cited, as appropriate:

OWN:           I am the Original Data Submitter for this study.

EXC:            I have obtained written permission of the Original Data Submitter to cite this exclusive-use study in support of this application.

PER:            I have obtained the permission of the Original Data Submitter to use this study in support of this application.

OLD:            The study was submitted more than  15 years ago and all periods of compensation have expired.

PL:             The study is in the public literature.

PAY:            I have notified in writing the Original Data Submitter or, if the cite-all method is used, all  companies listed in the most current Data Submitters List for this ingredient, and have
                offered (a) to pay compensation in accordance  with FIFRA sections 3(c)(1)(F) and/or 3(c)(2)(B), and (b) to commence negotiations to determine the amount and terms of
                compensation, if any, to be paid for the use of the study(ies).

GAP:            This Guideline data requirement is a data  gap as defined in 40 CFR sections 152.83(a) and 152.96.

FOR:            I am taking the formulator's exemption for this ingredient only. Other columns of this line should be marked "NA".  However, if this product is to be registered/reregistered for
                additional uses for which the purchased EPA registered ingredient is not supported, additional data must be submitted or cited here to support those uses.

Note:            If additional explanation is needed, enter a footnote number in this column and attach the corresponding explanation.



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                                                                                                                  Form Approved OMB No. 2070-0060
                                           UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                                                   401 M Street, S.W.
                                                           WASHINGTON, D.C.  20460
  Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1.25 hours per response for registration
  and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send
  comments regarding burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE
  Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460.
  Do not send the completed form to this address.
                                             Certification with Respect to Citation of Data
Applicant's/Registrant's Name, Address, and Telephone Number
Active Ingredient(s) and/or representative test compound(s)
General Use Pattern(s) (list all those claimed for this product using 40 CFR Part 158)
EPA Registration Number/File Symbol
Date
Product Name
     NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for all the same uses on your label, you do not need to
  submit this form. You must submit the Formulator's Exemption Statement (EPA Form 8570-27).
         I am responding to a Data-Call-in Notice, and have included with this form a list of companies sent offers of compensation (the Data Matrix form should
         be used for this purpose).
                                         SECTION I: METHOD OF DATA SUPPORT (Check one method only)
         I am using the cite-all method of support, and have included with this form
         a list of companies sent offers of compensation (the Data Matrix form
         should be used for this purpose).
I am using the selective method of support (or cite-all option
under the selective method), and have included with this form a
completed list of data requirements (the Data Matrix form must be
used).
                                                     SECTION II: GENERAL OFFER TO PAY
  [Required if using the cite-all method or when using the cite-all option under the selective method to satisfy one or more data requirements]

  I   I    I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFRA.
                                                          SECTION III: CERTIFICATION
           I certify that this application for registration, this form for reregistration, or this Data-Call-in response is supported by all data submitted or cited in the
  application for registration, the form for reregistration, or the Data-Call-in response. In addition, if the cite-all option or cite-all option under the selective method is
  indicated in Section I, this application is supported by all data in the Agency's files that (1) concern the properties or effects of this product or an identical or
  substantially similar product, or one or more of the ingredients in this product; and (2) is a type of data that would be required to be submitted under the data
  requirements in effect on the date of approval of this application if the application sought the initial registration of a product of identical or similar composition and
  uses.

           I certify that for each exclusive use study cited  in support of this registration or reregistration, that I am the original data submitter or that I have obtained
  the written permission of the original data submitter to cite that study.

           I certify that for each study cited in support of this registration or reregistration that is not an exclusive use study, either: (a) I  am the original data
  submitter; (b) I have obtained the permission of the original data submitter to use the study in support of this application; (c) all periods of eligibility for
  compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company that submitted the study and have
  offered (I) to pay compensation to the extent required  by sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA; and (ii) to commence negotiations to determine the
  amount and terms of compensation, if any, to be paid for the use of the study.

           I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of their delivery in
  accordance with sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA are available and will  be submitted to the Agency upon request. Should I fail to produce such
  evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformity with
  FIFRA.

           I certify that the statements I have made on this form and all attachments to it are true, accurate, and complete. I  acknowledge that any
  knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature
Date
Typed or Printed
Name and Title
EPA Form 8570-34 (9-97) Electronic and Paper versions available. Submit only Paper version.
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           APPENDIX E - LIST OF AVAILABLE RELATED DOCUMENTS

       The following is a list of available documents for Dichlobenil that my further assist you in
responding to this Reregi strati on Eligibility Decision document. These documents may be obtained
by the following methods:

Electronic
File format:   Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible reader.
             Electronic copies can obtained from our website at www.epa.gov/REDs,  or contact
             Dana Lateulere at (703)-308-8044.

       1.     PR Notice 86-5.

       2.     PR Notice 91-2 (pertains to the Label Ingredient Statement).

       3.     A full copy of this RED document.

       4.     A copy of the fact sheet for Dichlobenil.


       The following documents are part of the Administrative Record for Dichlobenil and may
included in the EPA's Office of Pesticide Programs Public Docket.  Copies of these documents are
not available electronically, but may be obtained by contacting the person listed on the Chemical
Status Sheet.

       1.     Health and Environmental Effects Science Chapters.

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

       The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.

       1.     The Label Review Manual.

       2.     EPA Acceptance Criteria
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