United States       Prevention, Pesticides    EPA738-R-96-019
        Environmental Protection   And Toxic Substances    March 1997
        Agency	(7508W)	
&EPA Reregistration
        Eligibility Decision (RED)

        Mepiquat  Chloride

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  ,588,
                   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
reregistration eligibility review and decisions on the pesticide chemical case Mepiquat
Chloride (N,N-Dimethylpiperidinium chloride). The enclosed Reregistration Eligibility
Decision (RED) contains the Agency's evaluation of the data base of these chemicals, its
conclusions of the potential human health and environmental risks of the current product uses,
and its decisions and conditions under which these uses and products will be eligible for
reregistration. The RED includes the data and labeling requirements for products for
reregistration. It may also include requirements for additional data (generic) on the active
ingredient 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
date 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 the pesticide law (FIFRA) and the food and
drug law (FFDCA). This RED takes into account, to the extent currently possible, the new
safety standard set by FQPA for establishing and reassessing tolerances. However, it should
also 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 Reregistration Division representative
Emily  Michell (703) 308-8583. Address any questions on required generic data to the Special
Review and Reregistration Division representative Patrick Dobak (703) 308-8180.

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

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

1.  DATA CALL-IN (PCI) OR "90-DAY RESPONSE"  If generic data are required for
reregistration, 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 REQUESTS 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 reregistration) separately.  You may, but are not
required to, delete uses which the RED says are ineligible  for reregistration.  For further
labeling guidance, refer to the labeling section of the EPA publication "General Information
on Applying for Registration in the U.S., Second Edition,  August 1992" (available from the
National Technical Information Service, publication #PB92-221811; telephone number 703-
487-4650).

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

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      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
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 reregistration determination within 14 months after the RED
has been issued.

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REREGISTRATION ELIGIBILITY DECISION

             Mepiquat Chloride

                   LISTB

                 CASE 2375
           ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF PESTICIDE PROGRAMS
        SPECIAL REVIEW AND REREGISTRATION DIVISION

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                                TABLE OF CONTENTS
MEPIQUAT CHLORIDE REREGISTRATION ELIGIBILITY DECISION TEAM	i
EXECUTIVE SUMMARY	v
I.     INTRODUCTION	1
II.    CASE OVERVIEW	2
      A.    Chemical Overview	2
      B.    Use Profile	2
      C.    Estimated Usage of Pesticide	3
      D.    Regulatory History  	4
III.   SCIENCE ASSESSMENT  	4
      A.    Physical Chemistry Assessment  	4
      B.    Human Health Assessment  	5
            1.     Toxicology Assessment 	5
                  a.    Acute Toxicity	5
                  b.    Subchronic Toxicity  	6
                  c.    Chronic Toxicity	7
                  d.    Carcinogenicity 	8
                  e.    Developmental Toxicity	9
                  f.     Reproductive Toxicity	10
                  g.    Mutagenicity	11
                  h.    Metabolism	12
                  i.     Neurotoxicity	13
            2.     Dose Response Assessment	13
                  a.    Reference Dose	13
                  b.    Carcinogenicity Classification and Risk Quantification	13
                  c.    Other Toxicological Endpoints for Risk Assessment  	13
            3.     Dietary Exposure and Risk Assessment/Characterization  	14
                  a.    Dietary Exposure  	14
                  b.    Dietary Risk Assessment/Characterization   	18
            4.     Occupational   and   Residential  Exposure   and   Risk   Assessment/
                  Characterization  	19
                  a.    Residential Exposure and Risk Assessment  	19
                  b.    Occupational Mixer/Loader/Applicator Exposure Assessment ... 19
                  c.    Occupational Risk Assessment/Characterization	19
            5.     Food Quality Protection Act (FQPA) Considerations  	22
                  a.    Potential Risks to Infants and Children  	22
                  b.    Aggregate Exposure/Risk	24
                  c.    Cumulative Effects	25
      C.    Environmental Assessment  	26
            1.     Ecological Toxicity Data  	26
                  a.    Toxicity to Terrestrial Animals	26
                  b.    Toxicity to Aquatic Animals	27
                  c.    Toxicity to Plants	30

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            2.    Environmental Fate 	32
                  a.    Environmental Fate Assessment  	32
                  b.    Environmental Fate and Transport  	33
                  c.    Water Resources	35
            3.    Ecological Exposure and Risk Characterization	35
                  a.    Exposure and Risk to Nontarget Terrestrial Animals   	37
                  b.    Exposure and Risk to Nontarget Aquatic Animals  	39
                  c.    Exposure and Risk to Nontarget Terrestrial and Semi-Aquatic Plants
                          	41
                  d.    Endangered Species	41
IV.   RISK MANAGEMENT AND REREGISTRATION DECISION 	42
      A.    Determination of Eligibility	42
      B.    Determination of Eligibility Decision	42
            1.    Eligibility Decision	42
            2.    Eligible and Ineligible Uses  	43
      C.    Regulatory Position	43
            1.    Food Quality Protection Act Findings  	43
            2.    Tolerance Reassessment   	45
            3.    Tolerance Revocations and Import Tolerances	45
            4.    Specific Tolerance Reassessment Actions  	46
            5.    CODEX Harmonization   	47
            6.    Tolerance Reassessment Conclusions with Respect to FQPA   	47
            7.    Labeling Rationale/Risk Mitigation: Occupational	47
            8.    Spray Drift Advisory  	48
V.    ACTIONS REQUIRED OF REGISTRANTS	49
      A.    Manufacturing-Use Products	49
            1.    Additional Generic Data Requirements  	49
            2.    Labeling Requirements for Manufacturing-Use Products  	49
      B.    End-Use Products  	50
            1.    Additional Product-Specific Data Requirements  	50
            2.    Labeling Requirements for End-Use Products	50
      C.    Tolerance Revocation and Import Tolerances	54
      D.    Existing Stocks	54
VI.   APPENDICES	57
      APPENDIX  A.    Table of Use Patterns Subject to Reregistration	59
      APPENDIX  B.    Table of the Generic Data Requirements and Studies Used to Make the
            Reregistration Decision	65
      APPENDIX  C.    Citations Considered to be Part of the  Data Base  Supporting the
            Reregistration of mepiquat chloride  	71
      APPENDIX  D.    Product Specific Data Call-in	83
            Attachment 1.    Chemical Status Sheets	95
            Attachment 2.    Product Specific Data Call-In Response Forms (Form A inserts)
                  Plus Instructions  	96
            Attachment 3.    Product Specific Requirement Status and Registrant's Response
                  Forms (Form B inserts) and Instructions  	99

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      Attachment  4.     EPA  Batching of  End-Use  Products  for  Meeting  Data
            Requirements for Reregistration	 107
      Attachment  5.     List of All Registrants Sent This Data Call-in (insert) Notice
             	 109
      Attachment  6.     Cost Share, Data Compensation Forms, Confidential Statement
            of Formula Form and Instructions  	 110
APPENDIX E.     List of Available Related Documents  	 115

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MEPIQUAT CHLORIDE REREGISTRATION ELIGIBILITY DECISION TEAM

Office of Pesticide Programs:

Biological and Economic Analysis Assessment
Alan Halvorson
Anita Hanson
George Keitt
Economic Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Environmental Fate and Effects Risk Assessment
Karen Angulo
Dan Balluff
Gail Maske

Health Effects Risk Assessment

Mary Clock
Tom Campbell
Felicia Fort
Krystyna Locke
Brian Steinwand

Registration Support Risk Assessment

James Stone
Tina Levine

Risk Management

Patrick Dobak
Kathleen Depukat
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Risk Characterization and Analysis Branch
Occupational and Residential Exposure Branch
Reregistration Support Chemistry Branch
Toxicology Branch I
Dietary Risk Evaluation Section
Fungicide-Herbicide Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch

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11

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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
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.
pg/g           Micrograms Per Gram
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
NOEC          No effect concentration
                                                111

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            GLOSSARY  OF TERMS  AND  ABBREVIATIONS

NPDES         National Pollutant Discharge Elimination System
NOEL          No Observed Effect Level
NOAEL        No Observed Adverse Effect Level
OP            Organophosphate
OPP           Office of Pesticide Programs
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*j            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 © 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.
ug/L           Micrograms per liter
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 and active ingredient mepiquat chloride.  This  decision includes a
comprehensive reassessment of the required target data and the use patterns of currently registered
products.  Mepiquat chloride's only registered use is as a growth regulator on cotton.   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.

       In establishing or reassessing tolerances, FQPA required the Agency to consider available
information  on  aggregate exposures to pesticide  residues, including all anticipated dietary
exposures  and other exposures for which there is reliable information, as well as the potential for
cumulative effects from a  pesticide and other  compounds with a common mechanism  of toxicity.
The Act further  directs EPA to consider the potential for increased susceptibility of infants and
children to the toxic effects of pesticide residue.

       For mepiquat chloride the only type of exposure evaluated was dietary, since it has not
been found in drinking water and no significant non-occupational exposure is expected.  Structural
similarities  exist between mepiquat chloride and difenzoquat and there  appears to be similar
neurotoxic effects.  The  Agency concludes  that cumulative  effects would be virtually nil from
dietary exposure  to mepiquat chloride and difenzoquat for all population subgroups because of the
small dietary contribution from each chemical.  Therefore, the Agency has determined that the
existing tolerances with amendments and changes  as specified in this document meet the standards
of FQPA.  Under FIFRA, the Agency has concluded that this use, as described in this document,
will not cause unreasonable risks to humans or the environment. The Agency has determined that
the cotton use of mepiquat chloride  is eligible for reregistration.

       Based on the lack of significant human health or environmental risks, the Agency is not
requiring  any additional  mitigation measures beyond those required by the Worker Protection
Standard (WPS). Residue data supporting cotton gin byproducts have been required.

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

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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 mepiquat chloride including the risk to infants and children for any potential
dietary,  drinking water,  dermal, inhalation or other oral exposures, and cumulative effects as
stipulated under the FQPA.  The document consists of six sections. Section I is the introduction.
Section II describes mepiquat chloride, 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  mepiquat chloride. Section V
discusses the reregistration requirements for mepiquat chloride.   Finally,  Section VI is  the
Appendices which support this Reregistration Eligibility  Decision. Additional details concerning
the Agency's review of applicable  data are available on request.


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II.    CASE OVERVIEW
      A.     Chemical Overview

      The following active ingredient is covered by this Reregistration Eligibility Decision:

      Common Name:           Mepiquat Chloride

      Chemical Name:           N,N-Dimethylpiperidinium chloride

      Chemical Structure:
                        H
                              0
                                             H
                            	 n_     C	 H
                                          H
                                 H
                                                                Cl
      CAS Registry Number:     24307-26-4

      OPP Chemical Code:      109101

      Empirical Formula:        C7H16C1N

      Trade and Other Names:   Fix®
      Basic Manufacturer:
                   BASF
      B.
Use Profile
      The following is information on the currently registered use with an overview of use sites
and application methods.  A detailed table of this use of Mepiquat Chloride is in Appendix A.

For Mepiquat Chloride:
Type of Pesticide:
             Plant growth regulator

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Use Sites:
Cotton
Target Pests:

Formulation Types
Registered:
Mechanism of Action:
N/A
Manufacturing  Product  (liquid, 99% AI)  Soluble  Concentrate,
Formulation Intermediate, Emulsifiable Concentrate  (liquid, 4.2 to
23.5%)  Water  Dispersible  Granules  (dry flowable,  35%  AI)
Pelleted/Tableted (99% AI)

Inhibits gibberellic acid synthesis, reduces internode length, hastens
maturity, retards abscission, increases yield potential.
Method and Rates of Application:

       Equipment -         Aerial application, ground boom

       Method and  Rate -   Soluble concentrate liquid
                            At post-emergence,  one  or  more spray  or ultra low volume
                            treatments by aircraft or ground equipment at 0.022 Ib/A to 0.044
                            Ib/A (not to exceed 0.132 lb/ai/A/season).

       Timing -             4/year maximum

       C.     Estimated Usage of Pesticide

       This section summarizes the best estimates available for the pesticide  use  of mepiquat
chloride.  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.

       Table 1 summarizes mepiquat chloride's average annual  cotton use for  1993-1995.
                    Table 1: Estimated Typical Annual Usage of Mepiquat Chloride
Acres (000)
Planted
13,595
Acres Treated (000)
Likely
Average
4,510
Likely
Max
6,215
% of Crop Treated
Likely
Average
33
Likely
Max
46
Lb AI Applied (000)
Likely
Average
135
Likely
Max
200
Avg. Application Rate
Ibai/
year
0.030
appl
/
year
1.4
lb/ai/
A/app
1
0.021
States of Most
Usage and %
of Usage in
these States
MS CA AR TX
LA NC: 77%
   Sources:
   - Gianessi and Anderson, Pesticide Use in U.S. Crop Production, National Summary Report, Feb. 1995.
   - US EPA proprietary sources, 1987-1995.
   - USDA/NASS, Agricultural Chemical Usage, 1991-1994 Field Crops Summaries.
   - USDA/NASS, Crop Production, 1993-1994 Summaries.

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       D.    Regulatory History

       The active ingredient mepiquat chloride was first registered in the United States in 1980
for use as a growth regulator of cotton.  The Phase 4 Data Call-In for this active ingredient was
issued in April  1991 requiring  additional  residue and worker exposure data.   Additional
ecotoxicity data were required in January 1994. In October 1995, a DCI covering agricultural
workers was issued for about 200 chemicals, including mepiquat chloride.  There are currently
nine products registered to three companies.  The two subsequent registrants have entered the
market since the  original patent expired.
III.    SCIENCE ASSESSMENT

       A.    Physical Chemistry Assessment

TGAI:              Mepiquat chloride

Color:                    Off-white
Physical State:

Odor:

Melting Point:

Bulk density:

Solubility:



Vapor Pressure:
Powder

Slightly sweet, musty smell

> 300°C (with discoloration at about 296°C)

       0.421  ± 0.07g/mL

Octanol - 0.95 g/100 mL
Water- 52.9 g/100 mL
Methanol - 5 g/100 mL

< 2.3x 106Torrat25.3°C
Octanol/Water Partition
Coefficient:         Knw<  10
pH:

Stability:
6.74 ± 0.01

Stable

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       B.     Human Health Assessment

              1.     Toxicology Assessment

       The toxicological data base for mepiquat chloride is substantially complete and will support
reregistration eligibility.  However, the Agency has required a rabbit developmental study as
confirmatory data.  Both the original and the replacement rabbit developmental studies reviewed
rely on X-ray evaluation of the fetuses and are unacceptable. The purity information necessary
to upgrade the subchronic dog study was requested of the registrant, but was not available.  Since
an acceptable chronic dog study is available, requiring a new subchronic  dog study will not add
significant knowledge to the human health database for this chemical.

                    a.     Acute Toxicity

       Table  2 below summarizes the acute toxicity studies on mepiquat chloride and the toxicity
categories for the different routes of administration.

               Table  2:  Acute Toxicity Data for Technical Grade Mepiquat Chloride
Test
Acute Oral LD50 (Rat)
Acute Dermal LD50 (Rat)
Acute Inhalation LC50 (Rat)
Eye Irritation (Rabbit)
Dermal Irritation (Rabbit)
Dermal Sensitization (Guinea pig)
Results
464 mg/kg
> 2000 mg/kg; Limit dose
> 4.89mg/L; HOT
Not an irritant; Score: 1.4/110
Not an irritant; Score: 0/4
Negative
Category
II
III
IV
IV
IV
-
       An acute oral toxicity study in Wistar rats found the LD50 for mepiquat chloride to be 464
mg/kg for both sexes, placing mepiquat chloride in toxicity category II or moderately toxic to rats
(MRID 41488101).

       An acute dermal study in male and female Wistar rats found the LD50 to be greater than
2000  mg/kg, placing mepiquat chloride in toxicity category III for dermal toxicity,  or slightly
toxic to rats (MRID 41488102).

       A rat acute inhalation study determined the LC50 to be greater than 4.89 mg/L, placing
mepiquat chloride in inhalation toxicity category  IV, practically  non-toxic to rats for acute
inhalation (MRID 41954101).

       A primary eye irritation in young adult  New Zealand white male and female  rabbits
concluded that mepiquat chloride is not an ocular irritant (MRIDs 00071942, 92091006).

       A primary  dermal irritation study in young adult  New Zealand white male and female
rabbits concluded that mepiquat chloride is not a dermal irritant (MRIDs 41488103, 92091007).

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       A dermal sensitization study in Pirbright White Guinea Pigs concluded that mepiquat
chloride is not a skin sensitizer (MRID 41488104, 92091008).

                    b.     Subchronic Toxicity

       Rat

       In a subchronic toxicity study, Wistar rats  (10/sex/group) were fed mepiquat chloride
(57.9% purity) in the diet for 3 months.  Based on  the results of a 4-week range-finding study,
the dose levels selected for this study were 0, 250,  1000, 4000 or 8000 ppm. However, due to
an error in the preparation of the diets which was discovered after the in-life portion of the study,
(no adjustment for purity of mepiquat chloride was made)  the actual dose  levels  of mepiquat
chloride fed to the rats were 145, 579, 2316 or 4632 ppm.  Mepiquat chloride,  at all levels tested,
had no effect on any parameters examined  in the study.  There were no unscheduled deaths.  No
systemic  NOEL could  be determined from this study.  An additional study was conducted in
which rats were fed diets containing 0 or 12000 ppm (about 889 mg/kg/day)  of mepiquat chloride
for 3 months.  Toxic effects observed in the treated group were  tremors in all rats; decreased
body weight gain, food consumption and  food efficiency;  increase in thromboplastin time;
decrease in  serum  calcium,  creatinine  glucose,  total protein, albumin, globulin  and  the
triglycerides; reduced grip strength of forelimbs and  hindlimbs in both sexes;  prolonged reaction
time in the hot-plate test on day 93 in males; decreased absolute weight of liver,  kidneys and
adrenals in males, and liver and adrenals in females; decreased relative weight of liver in males;
and increased relative weight of kidneys and testes in males and of kidneys in females. No effect
on the macroscopic and microscopic pathology was observed.

       These two studies together are acceptable and satisfy the requirements  for guideline 82-1,
for a subchronic feeding study in the rat and aid in the dose selection for the chronic feeding
study.  The NOEL for males and females is 4632 ppm (about 346 mg/kg/day) and the LOEL for
males and females is 12000 pm (about 889 mg/kg/day)  (MRIDs 42337102, 42337103).

       Dog

       In  a subchronic  toxicity  study,  technical  mepiquat chloride (no  purity given) was
administered to 4 beagle dogs/sex/dose in the diet  at dose levels  of 0, 100,  300, 1000 or 3000
ppm (0, 3.3, 9.8, 32.4 or 95.3 mg/kg/day). The LOEL is 3000 ppm (95.3  mg/kg/day), based
on clinical signs of toxicity (slight sedation); inhibition of body weights (up to 14% less); and
hematological effects (up to 14% reduction  in hemoglobin content and number of erythrocytes and
reduced hematocrit). The NOEL is 1000 ppm  (32.4 mg/kg/day).

       This  subchronic toxicity study is classified as upgradable, because of the lack of test
material purity information.  The Agency, however, has waived this requirement, based on the
availability of an acceptable chronic dog study.  Therefore, the additional information to upgrade
the study is not being required (MRID 135720).

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                    c.     Chronic Toxicity

       Rat

       In a chronic feeding study mepiquat chloride (58%) was administered for 24 months in the
diet to 20 Wistar rats/sex/dose at concentrations of 0, 290, 2316,  or 5790 ppm (active ingredient),
equivalent to doses of 0,  13, 106, 268 mg/kg/day for males and 0,  18, 146, or 371 mg/kg/day
for females, respectively.

       Total food consumption for rats in the high (5790 ppm)  and medium (2316 ppm) dose
groups was decreased for males and females relative to controls.  The NOEL is 2316 ppm (106
mg/kg/day). The  LOEL is 5790 ppm (268 mg/kg/day) based upon decreased body weights and
body weight gains for males and females, increases in urinary crystals for males  and pathological
changes in the adrenal cortex in  females.  This study is classified as acceptable and satisfies the
requirements for a chronic feeding study in rats (GDLN 83-la) (MRID 43264402).

       Dog - Study 1

       In  a chronic toxicity study, mepiquat chloride (99.5%)  was administered to 6 beagle
dogs/sex/dose  in the  diet at dose levels of  0, 200,  600  or 1800 ppm (0, 6.3,  19.9 or 58.4
mg/kg/day, respectively) for 12 months.  The only treatment-related effect, observed at the 1800
ppm dose, was a very slightly increased (Grade 2 on  the scale 1-5)  storage of the iron pigment
in the spleen of 3 male dogs and in the liver of  2 male dogs.  All of the remaining male and
female dogs in this group, and all  of the males and the majority of the females  in the remaining
groups,  including the controls, also had iron pigment in  the spleen and liver, but of slightly lesser
severity (Grade 1).  There were no compound-related effects in mortality, clinical signs, body
weight,  food consumption, ophthalmoscopic findings, hematology, clinical chemistry, urinalysis,
organ weights, gross  pathology  and, with the exception of the iron pigment noted above,
histologic  pathology (MRID  41488105).

       Dog - Study 2

       In  a second chronic toxicity study, mepiquat chloride [56.05% a.i.(w/w) in water] was
administered to 6 beagle dogs/sex/dose  in  the  diet  at dose  levels of 0 or  6000 ppm (170
mg/kg/day)  for 12 months in order to establish a  NOEL.

       Based on  the results of the  two chronic  dog studies, the  NOEL is 1800 ppm  (58.4
mg/kg/day) and the LOEL  is  6000 ppm (170  mg/kg/day) based on  impaired neurological
functions; epithelial vacuolization of the  renal distal  tubules;  and increased hemosiderin (iron
pigment; Grade 2) in the spleen (males only).   Considered together,  these studies are acceptable
and satisfy the requirement for the  chronic oral study (GDLN 83-Ib) in dogs (MRIDs 41488105
and 43264403).

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                    d.     Carcinogenicity

       Rat

       In an oncogenicity study,  mepiquat chloride was administered for 24 months in the diet
to 50 Wistar rats/sex/dose at concentrations of 0, 290, 2316, or 5790 ppm (active ingredient),
equivalent to doses of 0, 13, 105, 269 mg/kg/day for males and 0, 17, 141, or 370 mg/kg/day
for females, respectively.

       There were no treatment-related neoplastic findings for males or females treated with
mepiquat chloride. Thus,  mepiquat chloride did not exhibit carcinogenic potential in a 2-year
feeding study  involving male and female Wistar rats over this dose range.  Based upon the
decreased body weights and body weight gains, 5790 ppm is a maximum tolerated dose (MTD)
for mepiquat  chloride for 2-year feeding to  male and female Wistar rats,  and adequate for
identifying carcinogenic potential.   The LOEL for males and  females is  5790  ppm  (269
mg/kg/day), based upon decreased body weights,  body weight gains, food consumption, food
efficiency;  and macroscopic  and non-neoplastic microscopic pathological findings.  The NOEL
for males and females is 2316 ppm (105 mg/kg/ day)  (MRID 43396001).

       Mouse

       In  another oncogenicity study,  mepiquat chloride was administered in the diet for 24
months to B6C3Fl/CrlBr  (50  mice/sex/dose) and for  12  months  (10  mice/sex/dose)  at
concentrations of 0,  500, 2000,  or 7500 ppm (active ingredient).  These respective doses are
equivalent to 0, 74, 297, or  1140 mg/kg/day for males and 0, 85, 328, or 1348 mg/kg/day for
females, averaged over the 24-month feeding study.

       There were no treatment-related effects of mepiquat chloride administration on group mean
body weights  or body weight gains over  the  24-month treatment  period.  There were no
treatment-related macroscopic, non-neoplastic  microscopic pathological or neoplastic findings for
males or females treated with mepiquat chloride.  Thus, mepiquat  chloride  does not exhibit
carcinogenic potential  in a 2-year feeding study involving male and female B6C3F1 mice over this
dose range.  Based  upon  the  lack of  treatment-related  findings,  mepiquat chloride was  not
administered at the MTD.  However, the  high dose (7500 ppm or 1140 mg/kg/day) for the study
was  sufficient  to assess carcinogenicity since the limit dose of 1000 mg/kg/day  was exceeded.
The NOEL for mepiquat chloride administered for 2 years in food is  7500 ppm (1140 mg/kg/day)
for male and female B6C3F1 mice.

       This study is acceptable and satisfies the guideline requirements for an oncogenicity study
in mice (GDLN 83-2(b)) (MRID  43264404).

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                    e.     Developmental Toxicity

       Rat

       In a  developmental  toxicity  study,  pregnant  Wistar strain  rats, 25/group,  were
administered aqueous solutions of mepiquat chloride (57.9% purity) by gavage during gestation
days (GD) 6 through 15. The doses used were 0, 50,  150 or 300 mg/kg/day and were based on
the results of the range finding study in which 100, 300 or 600 mg  of mepiquat chloride/kg/day
were tested.

       Treatment-related maternal effects were observed only in the high-dose  (300 mg/kg) group
and included  clinical signs of toxicity and decreases in the food consumption and body weight
gain. These effects were not observed when dosing with mepiquat chloride was discontinued.
There were no unscheduled mortalities.

       Most dams (22-24/25) in the high-dose group showed pronounced but reversible tremors,
unsteady gait, indrawn flanks and hypersensitivity, whereas 4/25 dams also had ataxia.  All of
these findings were noted at approximately 1.5-2.0 hours after dosing, lasted for about 4 hours
and, with the exception of ataxia,  were less frequent during the second half of the treatment
period.  Ataxia was  observed in 2 dams during GD 7  only, in one dam during GD 8 and in
another dam during GD 9.

       Compared with the control values, food consumption of the high-dose dams was reduced
by 10-19% during the greater part of the dosing period (GD 6-13), but not thereafter.  Mean body
weight gains were also reduced  during the same period by 16-65%,  when  compared with the
control values. However, when mean body weights on GD 20 were corrected for uterine weights,
the high-dose dams weighed 13% less than the controls.

       Mepiquat chloride, at the three  levels tested, had no effect on all of the developmental
toxicity parameters examined.   No embryotoxicity, fetotoxicity and no  indications  of any
teratogenic effects were  observed in this study. The Maternal Toxicity LOEL and NOEL are 300
and  150  mg/kg/day,  respectively, based on  clinical   signs of  toxicity,  decreases in food
consumption and body weight gain. The  developmental NOEL > 300 mg/kg/day.  The guideline
83-3 requirement for a developmental toxicity study in rats is satisfied (MRID 42337101).

       Rabbit

       In a developmental  toxicity study, technical mepiquat  chloride (99% a.i.) was  fed to
artificially inseminated Himalayan rabbits  (21-22/group)  in aqua bidest (twice distilled water) at
dose levels of 0 (untreated control), 0 (vehicle control), 50, 100 and  150 mg/kg/day.  The dosing
was done by gavage (in a volume of 5 mL/kg of body weight) during  GD 6-18 and the animals
were sacrificed on GD 28. The animals received  130 g of dry food per day and water ad libitum
during  the study.

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       In the 50 mg/kg group, there was 1 abortion on day 26, weight loss and decreased food
consumption during GD 6-12, and various amounts of amber-colored liquid in the abdomens of
5 rabbits. In the 100 mg/kg group, there was weight loss during GD 6-12 and decreased body
weight gain during GD 12-28; decreased food consumption during GD 6-18;  amber-colored liquid
in the abdomens of 2 rabbits; diarrhea, trembling and apathy in one rabbit; and 6 abortions during
days  18-28.  In the 150 mg/kg group, there were 7 deaths during GD 6-18; 4 abortions during
GD 18-21;  weight loss during GD 6-18; decreased food consumption during GD 6-28; amber-
colored liquid in the abdomens of 3 rabbits; and heart dilatation and hyperemia of organs in the
nonsurvivors.

       Based on the above findings, the maternal NOEL is 50 mg/kg/day (borderline value) and
the  LOEL is 100 mg/kg/day. Developmental effects were not observed  in the 50 mg/kg group.
Because of high abortion rate in the 100 mg/kg group (6/16 pregnant = 37.5%), only 8 litters
and 26 fetuses were available for evaluation.  Because of high death rate  and abortion rate in the
150 mg/kg group  (total 10/17 pregnant = 58.8%), only 7 litters and 36 fetuses were available for
evaluation.  The inadequate numbers of fetuses in the mid-dose and high-dose groups precluded
the  meaningful evaluation of developmental toxicity in this study (MRIDs  148090, 92091010).

       The HED Reference Dose (RfD)/Peer Review Committee concluded on May 2, 1996 that
a new developmental toxicity study with rabbits (83-3b)  is required.  The currently available
studies are inadequate to meaningfully evaluate the developmental toxicity of mepiquat chloride
in that species. In one study (1979; MRID 00148090), too few fetuses were available in the mid-
dose and high-dose groups, and only X-rays (no staining techniques) were used for the evaluation
of fetuses. The second study (1981; MRID 00148089), in which two doses of mepiquat chloride
were tested, and in which X-rays were  also used to evaluate the fetuses, was reported only as a
brief summary and could  not be evaluated. The replacement study (MRID 44102201) has been
received by the Agency and reviewed, however since it  also relies on  X-ray evaluation of the
fetuses it will also not be acceptable. The review of this study's findings have not impacted the
Agency's developmental endpoint selection since they are consistent with existing information.

       The toxicological data base for mepiquat chloride is essentially complete and will support
reregistration eligibility.  A new rabbit developmental study is required as confirmatory data.

                    f.     Reproductive Toxicity

       In a two  generation reproductive toxicity study,  Wistar rats (25/group/sex) were fed
mepiquat chloride in their diets at concentrations of 0, 500,  1500, or 5000 ppm for 10 weeks (F0)
or 14 weeks (Fj) before  mating, and during mating, gestation, and lactation.  The F0 parents were
mated a second time 2 weeks after weaning the first litter. The doses corresponding to the dietary
concentrations are 51.2 and 48.6,  153.1 and 146.6, and 499.3 and 574.5 mg/kg/day, respectively
for  F0 and F1  males and 54.0  and 53.3, 163.6 and 162.0,  and 530.0 and 626.5 mg/kg/day,
respectively for F0 and F1 females.
                                           10

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       No treatment-related systemic effects occurred in male or female rats receiving 500 or
1500 ppm of the test material.  In animals receiving 5000 ppm (high-dose), effects indicative of
impaired neurological function included tremors and hypersensitivity upon handling in 70-85%
of F0 and Fl dams.  To a lesser extent, effects also included decreased forelimb and hindlimb grip
strength  in dams (before mating, during lactation or after weaning), decreased  hindlimb grip
strength  in high-dose Fl males,  relative reductions in mean body weights of the high-dose F
males.  Although mean body weights of high-dose Fl males were reduced by about 50% relative
to controls at the start of the premating period, by the end the animals had steadily  gained weight
such that the body weight gain was only slightly  reduced.  Effects also included reductions in
relative food consumption in Fl males, mean body weight and body  weight gain during the
premating period of high-dose F0 females, gestation body weight and  body weight gain of F
females, weight of high-dose F0 and Fl dams during lactation, weight gain of the Fl and F2 pups,
and food  consumption in the high-dose dams during lactation.  Changes  in hematologic, clinical
chemistry,  and urinalysis  parameters in the  adult  high-dose rats  were unrelated  to dose,
biologically insignificant, or were due to the reduced body weight.  Plasma, erythrocyte,  and
brain cholinesterase activities were not affected by treatment with the test material. Decreased
liver and  kidney weights and decreased incidence of lipid storage in the liver in observed in high-
dose males and females were consistent with the decreased terminal body weights and are unlikely
to be due to toxicity of the test material.  A significant number of high-dose  Fl and F2 pups were
slow in reaching developmental milestones, but these effects are attributed to retarded growth of
the pups.

       The LOEL for systemic toxicity is 5000 ppm (499 mg/kg/day) for male and female  rats
based on  neurological impairment, decreased body weight and body weight gain in the adults,  and
retarded  growth of Fl and F2 pups.  The corresponding NOEL is 1500  ppm (147 mg/kg/day).

       The OPP's Reference Dose (RfD)/Peer Review  Committee concluded on  May 2, 1996,
that, because of the retarded growth of  the pups in the 5000 ppm (499 mg/kg/day) group, the
systemic NOEL of 1500 ppm (147 mg/kg/day) would also be regarded as the reproductive NOEL.
This study is acceptable and satisfies the requirements for a multigeneration reproduction feeding
study (GDLN 83-4) (MRID 43378601).

                    g.     Mutagenicity

       In a reverse gene  mutation assay in bacteria, strains TA 1535, TA  1537,  TA 1538, TA
98 and TA 100 of S. typhimurium were exposed  to mepiquat chloride  (99.8% a.i.) in distilled
water at  concentrations of 0, 4,  20,  100,  500 or  2500 //g/plate in the presence and absence of
mammalian metabolic  activation (S-9 mix).  Mepiquat chloride  did not  induce a significant
increase  in revertant colonies at  any dose level up to 2500 jug/plate under the conditions of the
assay,  either with or without metabolic activation. Mepiquat chloride was neither tested up to
cytotoxic concentrations nor the limit concentration, 5000 //g/plate.  Solubility did not  appear to
be a problem and the positive controls induced  the appropriate responses in the corresponding
strains.  Mepiquat  chloride was neither  tested up  to  cytotoxic concentrations  nor  the limit
concentration, 5000//g/plate.


                                           11

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       This study is classified as acceptable for regulatory purposes and satisfies the requirement
for GDLN 84-2 for  in vitro mutagenicity  (bacterial reverse gene mutation) data.  Although
mepiquat chloride was not tested at high enough doses for an adequate negative study (the limit
dose is 5000 jug/plate), based on the results  from the two other mutagenicity studies below, the
two carcinogenicity studies, the rat reproduction study and the two developmental toxicity studies,
each negative for the specific effect being measured, retesting mepiquat chloride in the Salmonella
assay would not add any significant knowledge to the  current database  for this chemical.
Therefore, a new study is not required  (MRID 41488106).

       In an acceptable mammalian cell  cytogenetics assay (chromosome aberration in CHO
cells), CHO cell cultures were exposed to mepiquat chloride (< 99% a.i.) at concentrations of
2.0,  3.0, 4.0, or 5.0 mg/ml, both with and without metabolic activation.  Mepiquat chloride was
tested up  to the limit concentration, 5000 //g/mL.  Positive controls induced the appropriate
response.  There was no evidence  of induced increases  in  chromosomal  aberrations over
background (MRID 41488107).

       In an acceptable unscheduled DNA synthesis assay,  primary rat hepatocyte  cultures were
exposed to mepiquat chloride (99.86% a.i.)  at concentrations ranging from 0.026 to 5000 //g/mL
for 18-19 hours. Two trials were initiated, one ranging from  0.026 jUg/mL to 1020 jUg/mL and
the other ranging from 0.25 jug/ml to 5000  jug/ml. Mepiquat chloride was tested up to cytotoxic
concentrations.  The positive controls induced an appropriate positive response.   Under the
conditions of the assay, there was no evidence that mepiquat chloride induces an increase in
unscheduled DNA synthesis, as determined by radioactive tracer  procedures (nuclear silver grain
counts) when compared to the negative control group. In addition, there was no indication of a
dose-response (MRID 41488108).

                     h.      Metabolism

       In a metabolism study, mepiquat chloride, labeled  with 14C in the 2,6-carbon atoms of the
ring structure  (radiochemical purity: 98%), was administered to young adult Sprague-Dawley rats
(5/sex/group)  either intravenously or orally.  During the study,  the rats received a standard diet
(pellets) as follows: for body weight < 150 g:  10%  of body weight +  3 g; for body  weight > 150
g, 10% of body weight + 2 g. Water was provided  ad libitum.

       Mepiquat chloride was absorbed rapidly from the stomach, distributed evenly in the intra-
and extracellular compartments of the blood, demonstrated high bioavailability via the oral route,
was  excreted  mostly in  urine, and did not accumulate in tissues.  Other  excretions of the
administered radioactivity were as follows:  feces,  2-15%; exhaled air, (14C02), 0.20%; and bile,
0.23-0.31%.

       The bioavailability of mepiquat chloride appears to depend on the presence  of food in the
gastrointestinal tract.  In the two male rats used in the study of pulmonary elimination of mepiquat
chloride as 14C-volatiles, which had access to food immediately after dosing, the bioavailability
                                            12

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was much lower (58%) than that of a similar treatment group in which food was withheld until
4 hours after dosing (79%).

       Mepiquat chloride did not accumulate in tissues.  Urine,  feces and bile samples from
various treatments were used for studies of the metabolic fate of mepiquat chloride.  In all cases,
only the unchanged compound could be detected. Therefore, there was no biotransformation of
mepiquat chloride in vivo.  The potential metabolites, such as 1-methylpiperidine or piperidine,
were  not detected.  This study is  acceptable and satisfies the  guideline requirement  for a
metabolism study (GDLN 85-1) in the rat (MRID 40299001).

                    i.      Neurotoxicity

       Because of the limited use of mepiquat chloride (on cotton only), very low application
rates (0.022-0.044 Ib/acre, not to exceed 0.132 Ib a.i./acre/season) and the findings that mepiquat
chloride was neurotoxic in rats at high levels only (300-889 mg/kg/day), neurotoxicity studies
were not required.

             2.     Dose Response Assessment

                    a.      Reference Dose

       On May 2, 1996, the OPP's Reference Dose (RfD)/Peer Review Committee recommended
that the RfD  for mepiquat chloride be established at 0.6 mg/kg/day.  This value was based on the
systemic NOEL of 1800  ppm  (58.4 mg/kg/day) from the one-year dog feeding study and the
uncertainty factor (UF) of 100  (MRIDs 41488105 and 43264403).

                    b.      Carcinogenicity Classification and Risk Quantification

       The carcinogenic potential of mepiquat chloride was evaluated by the OPP's Reference
Dose  (RfD)/Peer Review  Committee on May 2,  1996.   The Committee classified mepiquat
chloride into  Group  E  (evidence of noncarcinogenicity  for humans),  based on a  lack  of
carcinogenicity in acceptable studies with two animal species, rat and mouse (MRIDs 43264404
and 43396001).

                    c.      Other Toxicological Endpoints for Risk Assessment

       The OPP's Toxicology  Endpoint Selection Committee (TESC) considered the available
toxicology data for mepiquat chloride at a meeting held on May 7,  1996.  Based upon a review
of the database, toxicology endpoints and dose levels of concern have been identified for use in
risk assessments.
                                          13

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                           (1)     Dermal Absorption

       Dermal absorption data are not available. The estimated dermal absorption was, therefore,
extrapolated from an oral toxicity study in rats and an acute dermal toxicity study in rats (MRIDs
41488101,  41488102). No toxic signs were observed in the dermal study at the limit dose used
(2000 mg/kg/day), but were observed at approximately 25% of that  dose (464 mg/kg/day) in the
oral study.  Toxic signs observed in the acute oral study, in the nonsurvivors, were dyspnea,
apathy, staggering, twitching and cyanosis.  The amount absorbed was estimated to be 23.2%,
based on the comparison of these two studies (acute oral LD50 divided by the acute dermal LD50).

                           (2)     Acute Dietary

       The endpoint for acute  dietary risk assessment was estimated based on the one-year dog
feeding study with the 90-day  dog feeding as a supporting study.  Since there were no definite
toxic effects detected in the one-year study in which the highest dose of mepiquat chloride tested
was 1800 ppm (58.4 mg/kg/day), another one-year study with 6000 ppm (170 mg/kg/day) doses
was conducted.  The endpoint and dose for use in risk assessment is  1800 ppm (58.4 mg/kg/day)
based on salivation (an indicator of impaired neurological functions) in all dogs at 2 hours after
each feeding observed at the 6000 ppm dose level. Salivation was slight at first,  moderate to
severe during the next 4 hours and then gradually disappeared.  In the subchronic feeding study,
sedation  (also a neurotoxic sign) was observed for 1-6 hours after each dosing with 3000 ppm
(95.3 mg/kg/day;  LOEL) of mepiquat chloride (MRIDs 41488105, 43264403, and 00135720).

                           (3)     Short   and   Intermediate  Term   Occupational   and
                                  Residential

       The  endpoint for short and  intermediate term  dermal exposure is  1800 ppm (58.4
mg/kg/day) based on the one-year dog feeding study and its supporting 90-day dog feeding study.
The NOEL from the 90-day study was not used for the dermal  short and intermediate term
exposure since it was only classified as supplemental and an acceptable one-year feeding study was
available.  The  endpoint for short-term inhalation exposure is 4.89 mg/L  (NOEL) based on the
acute inhalation  study in rats.  For intermediate term occupational inhalation exposure, is unlikely
because of the  limited use pattern (growth regulator for cotton only); the low application rates
(0.022-0.044 Ib/ai/A; not to exceed 0.132  Ib/ai/A/season), and low volatility (MRIDs 41488105,
43264403,  and  00135720).

             3.     Dietary Exposure and Risk Assessment/Characterization

                    a.     Dietary Exposure

       All residue chemistry data submissions in support of the reregistration of mepiquat chloride
have been reviewed. As a result of changes to Table II of the Pesticide Assessment Guidelines
(Subdivision 0, Residue Chemistry, 9/95), field residue data have been required for cotton gin
byproducts and a tolerance will be proposed for this commodity when adequate field residue  data

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have been submitted and reviewed.  These data are due to the Agency by March 17, 1997.  The
outcome of this new data requirement does not affect the reregistration eligibility decision.

       Additionally, tolerance revisions have been required.  Tolerances for residues of mepiquat
in/on cotton forage, cottonseed meal, eggs, milk, poultry fat, meat and meat byproducts will be
proposed for revocation. The existing data constitutes a substantially complete database sufficient
to assess dietary exposure and supports the reregistration of mepiquat chloride with respect to
residue chemistry.  (See Section IV.C for the complete list of tolerance revisions.)

                           (1)    Directions for Use (GDLN 171-3): Agricultural Food Uses

       The maximum single application rate is 0.044 Ib ai/A/application.  Up to four low-rate
applications, with 7- to 14-day retreatment  intervals,  may be made provided the maximum
seasonal rate of 0.132 Ib ai/A is not exceeded.  Application^) may be made using ground or aerial
equipment in a minimum of 2 gal of water per acre (GPA) except when application is made in
CA. In CA, the minimum spray volume for ground and aerial equipment is 5 GPA. Ultra low
volume (ULV) aerial applications, using oil as diluent (minimum spray volume of 2 pints oil/A),
are permitted for the SC/L formulations in AL, AR, FL, GA, LA, MO, MS, NC,  OK, SC, TN,
and  TX.    The  established pregrazing/feeding  and  preharvest  interval  is  30 days.   A
grazing/feeding restriction is in effect following ULV aerial applications in oil and for the DF
formulation.  Adequate field trial data are available to support the presently registered maximum
use patterns.  Adequate field trial data are also available to support the registrant's  increased
maximum seasonal rate from 0.066 Ib ai/A (Ix) to 0.088 Ib ai/A (1.3x) or 0.132 Ib ai/A (2x).

       The reregistration requirements for this guideline topic (GDLN  171-3) are fulfilled, except
for the need to establish  a  plantback interval which  had  not been previously established for
rotational crops. Therefore, based on an acceptable confined rotational crop study, the registrant
must amend all of its mepiquat chloride end-use products to establish a plantback interval of 2.5
months (42733601).

                           (2)    Plant Metabolism  (GDLN 171-4  (a))

       The reregistration requirements for plant metabolism are fulfilled.  An acceptable study,
depicting the qualitative nature of the residue in cotton plants,  has been submitted and evaluated.
Based on this study, it has been determined that the residue of concern in/on plant commodities
is mepiquat chloride per se.  The  current tolerance expression  for plant commodities is
appropriate (MRID 43024701).

                           (3)    Animal Metabolism (GDLN 171-4 (b))

       The reregistration requirements for animal metabolism are fulfilled. Acceptable studies,
depicting the qualitative nature of the residue in ruminant and poultry, have been submitted and
evaluated.  The residue of concern in animal commodities is mepiquat chloride per se.   The
                                           15

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current tolerance expression for animal commodities  is appropriate  (MRIDs 42394301/2/3,
43290401/2/3/4/5).

                           (4)     Residue Analytical Method-Plants and Animals (GDLNs
                                  171-4 (c) and (d))

       The reregistration requirements for residue analytical methods are fulfilled. Acceptable
methods are available for enforcement and data collection purposes for both plant and animal
commodities.

       Enforcement methods: The Pesticide Analytical Manual (PAM  Volume II) lists Method
I as available for the determination of residues of mepiquat chloride per se in/on plant and animal
commodities.  This GLC method, with nitrogen detection, has undergone  successful Agency
method tryout using  plant (cottonseed, cotton forage,  and cottonseed processed fractions) and
animal (milk, eggs, and meat of chicken and beef) matrices.  The stated limit of quantitation is
0.1 ppm for cotton and 0.05 ppm for animal products.

       Multi residue methods:  The FDA PESTDATA database dated 1/94 (PAM Volume I,
Appendix I)  does not have  an entry for mepiquat chloride.   The existing FDA multi-residue
methods are not likely to recover mepiquat chloride residues because of its ionic nature (MRIDs
42426801, 42734601/2, 42394393/4, 42546201/2, 42734601/2, 42892201, 43379501, 43738603).

                           (5)     Storage Stability  (GDLN 171-4 (e))

       The  reregistration requirements  for storage  stability data are adequately  fulfilled.
Adequate information is available concerning the maximum storage  intervals as well  as the
conditions of plant and processed commodities used in support of tolerance establishment or in
support  of data requested for reregistration.  Acceptable storage  stability studies have been
submitted for cotton and its processed  commodities.   These studies  have demonstrated that
residues of mepiquat chloride per sear e stable under frozen storage conditions at least 25 months
in/on cottonseed and for at least 28.5 months in cottonseed hulls, meal, crude  oil, refined oil, and
soapstock.

       The available plant and animal metabolism  studies are validated by adequate storage
stability data.  In conjunction with the  ruminant metabolism study, it was demonstrated that
residues of mepiquat chloride per se are stable under  frozen storage conditions  for at least 45
months in milk and liver.  An additional study depicting the freezer storage  stability of residues
of mepiquat chloride per se found residues to be stable for at least 26  months in ruminant and
poultry tissue and eggs (MRIDs 42734601/2, 42892201, 43379501, 43738603).

                           (6)     Magnitude of the Residue in Plants (GDLN 171-4 (k))

       The reregistration requirements for magnitude of the residue  in/on cottonseed are fulfilled.
Adequate cottonseed  field trial data, reflecting use of the registered SC/L and DF formulations

                                           16

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at the presently registered maximum use patterns, have been submitted.  Adequate field trial data
are also available to support the registrant's proposal to increase the maximum seasonal rate on
cotton plants from 0.066  Ib ai/A to 0.132 Ib ai/A.  It has been previously concluded that the
established tolerance of 2 ppm for cottonseed is sufficient to cover additional residues of mepiquat
chloride per se that may result from an increase in the maximum seasonal rate to 0.132 Ib ai/A
(42734601/2).

       According to Table II of the Pesticide Assessment Guidelines (Subdivision 0, Residue
Chemistry, 9/95), cotton forage is no longer considered a significant livestock feed item and has
been deleted from the table. Therefore, the  previously requested data for cotton forage are no
longer required and the established tolerance for this item should be revoked.  Table II now
recognizes cotton gin byproducts as a raw agricultural commodity of cotton.  Therefore, field
residue data must be submitted for cotton  gin byproducts and a tolerance must be proposed for
this commodity when adequate field residue data have been submitted.  These data have been
required and are due to the Agency by March 17, 1997.

                           (7)     Magnitude  of  the Residue in  Processed  Food/Feed
                                  (GDLN 171-4 (1))

       The reregistration  requirements  for magnitude of the  residue in processed  cottonseed
commodities are fulfilled.  An acceptable cottonseed processing study has been submitted. Any
residue that may result in cottonseed meal  as a result of processing will be covered by the RAC
tolerance.  Therefore, the established feed additive tolerance  of 3.0 ppm for cottonseed meal
should be revoked.

       The temporary  food and feed additive tolerances for grape processed  commodities,
originally established in accordance with an  approved experimental use  program, expired on June
30, 1991.  Since there are presently no registered uses of mepiquat chloride on grapes, these
expired food and feed additive tolerances should be revoked (MRID 42426803).

                           (8)     Magnitude of the Residue in Meat, Milk,  Poultry, and
                                  Eggs  (GDLN 171-4Q))

       The reregistration  requirements for magnitude of the residue in  livestock are fulfilled.
There  are no registered direct animal treatments for mepiquat chloride  on cattle, goats,  hogs,
horses, sheep or poultry.  The residue of concern in animals is mepiquat chloride per se, and
acceptable animal feeding studies depicting mepiquat chloride have been submitted and evaluated.

       The cattle feeding study indicated that the established tolerances of 0.1 ppm for mepiquat
chloride residues in fat, meat, and meat byproducts of cattle, goats, hogs, horses,  and sheep are
adequate.  Pursuant to 40  CFR  180.6(a) (3),  the milk tolerance will be proposed for revocation
since data indicated that no residues are  likely in this commodity.
                                           17

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       The poultry feeding study indicated that no residues were found in poultry tissue samples
at any dosage.  This assessment includes  the tolerances that will be proposed for revocation.
Based  on this  result,  there is no expectation of transfer of residues to poultry and eggs.
Therefore, since data indicate  that no residues are likely in these commodities, the poultry and
egg tolerances established at 0.1 ppm for poultry fat, meat, and meat by-products and at 0.05 ppm
for eggs will be proposed for revocation pursuant to 40 CFR 180.6(a) (3) (MRID 43738601).

                    b.     Dietary Risk Assessment/Characterization

       No dietary risks of concern were identified for mepiquat chloride for the general U.S.
population nor  any subgroup.  Pursuant to the requirements under the Food Quality Protection
Act of 1996, the Agency has determined that the use of mepiquat chloride will not pose dietary
risks to infants and children due primarily to the chemical's low toxicity and its low usage rate.

                           (1)     Chronic Dietary Risk Assessment

       A Dietary Risk Evaluation System (DRES) chronic exposure analysis was performed using
tolerance level residues  (including those  that will be proposed for revocation and the three grape
and raisin tolerances recently revoked)  and an assumption of 100 percent crop treated to estimate
the Theoretical Maximum Residue Contribution  (TMRC)  for the general population and 22
subgroups.  No Anticipated Residue  (AR) information was used in this analysis.   Existing
tolerances result in a Theoretical Maximum  Residue Contribution (TMRC) which represents less
than 1% of the RfD for  the U.S. general  population and each of the 22 sub-groups, including non-
nursing infants  (< 1 year old).

       The chronic analysis for mepiquat chloride is a worst case estimate of dietary exposure
with all residues at tolerance level and  100 percent of the commodities assumed to be treated with
mepiquat chloride.  Based on the risk  estimates calculated in this analysis, it has been concluded
that dietary exposure to mepiquat chloride  does not pose a risk concern.

                           (2)     Acute Dietary Risk Assessment

       The DRES detailed acute analysis estimates the distribution of single-day exposures for
the overall U.S. population and  the subgroups of Infants less than 1 year old, Children 1-6 years
old, and Females and Males 13+ years old.   The analysis evaluates individual food consumption
as reported by respondents in the USDA  1977-78 Nationwide Food Consumption Survey (NFCS)
and accumulates exposure to the chemical for each commodity.  Each analysis assumes uniform
distribution of mepiquat chloride in the commodity supply.

       The Margin of Exposure (MOE) is a ratio of the NOEL to the exposure.  Generally, the
Agency concludes that there is no dietary  concern when the acute dietary margins of exposure
greater are than 100.
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       The results of the acute analysis indicate that mepiquat chloride in the diet represents no
serious risk  concern for acute exposure.  All MOEs were well above the Agency's level of
concern for acute dietary risk (ranging from a low of 3,893 for Infants to a High of 29,200 for
Females 13+ years old).

              4.      Occupational and Residential Exposure and Risk Assessment/
                     Characterization

                     a.      Residential Exposure and Risk Assessment

       At this time products containing mepiquat chloride are only registered for occupational
uses.  Therefore, residential inhalation and dermal exposures to individuals, including infants and
children, are  not expected.

                     b.      Occupational Mixer/Loader/Applicator Exposure Assessment

       An occupational and/or residential exposure assessment is required for an active ingredient
if (1) certain toxicological criteria are triggered and (2) there is potential exposure to handlers
(mixers, loaders, applicators, etc.) during use or to persons entering treated sites after application
is complete. The short- and intermediate-term criteria for dermal exposure and short-term criteria
for inhalation exposure have been triggered as determined above in Section III.B.2.

       Mixer/loaders  of  mepiquat  chloride are  assumed to be  using  open  methods  of
mixing/loading, and ground applicators are assumed to be spraying mepiquat chloride from open-
cabbed tractors. Dermal absorption is estimated to be 23.2%.  Aerial applicators are assumed to
be spraying from aircraft with enclosed cockpits (engineering controls), as no data were available
for  open cockpit aircraft.   No gloves or respirators  are assumed to be worn for the baseline
exposure estimates.

       It has  been determined that there are potential exposures to mixers, loaders, applicators,
or other handlers during usual use-patterns associated with mepiquat chloride. Based on the use
patterns, six major exposure scenarios were identified for mepiquat chloride:  (la) mixing/loading
liquids for aerial application;  (Ib) mixing/loading liquids for groundboom application; (2a)
mixing/loading dry flowables  for  aerial application; (2b) mixing/loading dry flowables for
groundboom  application; (3) aerial  application of liquids (fixed-wing); (4) aerial application of
liquids  (helicopter);  (5)  groundboom application  of  liquids; and,  (6) flagging liquid  aerial
applications.

                     c.      Occupational Risk Assessment/Characterization

                            (1)    Occupational Mixer/Loader/Applicator Risk Assessment
                                            19

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       Short-term and intermediate-term dermal and inhalation exposures were estimated using
the Pesticide Handlers Exposure Database (PHED), Version 1.1 (no chemical-specific exposure
data were submitted).

       Potential Daily Exposure is calculated using the following formula:
        Daily Exposure
                    mgai\ _
                    Day
= Unit Exposure
me ai\  ,.   .   , „    Ib AI\  ,.   .   „   , f Acres\
——  x Max. Appl. Rate  	  x Max. Area Treated  	
Ib ai }               Acre }               { Day j
       The Daily Dermal Dose is calculated using the following formula:
                Daily Dermal Dose  ——	1  = Daily Dermal Exposure  ——I x 	
                             ( Kg/Day)      J       V    ( Day }  ( Body Weight (Kg)
       The Short-Term and Intermediate-Term Dermal MOEs were calculated using the following
formula:
                                           NOEL
                              MOE = 	
                                     Daily Dermal Dose    m§  \
                                                      { kg/day)

       Potential daily exposure  calculations are used to calculate an estimate of the daily dermal
dose of mepiquat chloride to handlers.  Risk resulting from dermal exposure is determined by
applying the  respective dermal  NOEL  to these exposure  estimates.   For  short-term  and
intermediate-term dermal risk assessment, a NOEL of 58 mg/kg/day was  used along with a 70
kg body weight.

       The Daily Inhalation Dose is calculated using the following formula:

              Daily Inhalation Dose  ——	1 = Daily Inhalation Exposure  ——I x
                            ( Kg/Day)                     ( Day j   ( Body Weight (Kg)

       The Inhalation MOEs were calculated using the following formula:

                                          NOEL
                            MOE =
                                                 kglday>
                                   Daily Inhalation Dose  - - —
                                                      I kg/day]

       The daily inhalation dose calculations of mepiquat chloride received by handlers are used
to estimate the inhalation risk to those handlers.  Risk resulting from inhalation exposure is
determined by applying the inhalation NOEL to these exposure estimates.   To calculate  the
inhalation dose of mepiquat chloride to handlers, a NOEL of 370 mg/kg/day was used along with
a 70 kg body weight.
                                            20

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             Table 3: Short-Term and Intermediate-Term Risk from Mepiquat Chloride
Exposure Scenario (scenario #)
Baseline
Absorbed Dermal
Dose
(mg/kg/day)a
Baseline
Absorbed
Dermal MOEb
Baseline
Inhalation Dose
(mg/kg/day)c
Baseline
Inhalation
MOEd
Mixer/Loader Risk
Mixing/Loading Liquids for Aerial
Application (la)
Mixing/Loading Liquids for
Groundboom Application (Ib)
Exposure Scenario (scenario #)
Mixing/Loading Dry Flowables for
Groundboom Application (2b)
0.0033
0.00076
0.0053
0.0012
17,576
76,316
10,943
48,333
0.0004
0.00009
0.00026
0.00006
9.3x 105
4.1x 106
1.4 x 106
6.2x 106
Applicator Risk
Aerial Application of Liquids using
Fixed- Wing Aircraft with Enclosed
Cockpit (3)
Aerial Application of Liquids using
Enclosed Cockpit Helicopter (4)
Groundboom Application of Liquids (5)
0.000366
0.00013e
0.00026
1.6x 105
4.5x 105
2.2x 105
0.000026
0.00043
0.000053
1.9x 107
8.6x 105
7. Ox 106
Flagger Risk
Flagging for Liquid Application (6)
0.00060
96,667
0.00009
4.1x 106
a Baseline Absorbed Dermal Dose = (daily dermal exposure x dermal absorption factor 23.2 percent) / 70 kg.
b Dermal Absorbed MOE = NOEL (58 mg/kg/day) / daily dermal dose, assuming baseline PPE (long pants, shirt, shoes and socks).
c Baseline Inhalation Dose (mg/kg/day) = daily inhalation exposure (mg/kg/day) / 70 kg, assuming 8 hour exposure.
" Inhalation MOE = NOEL (2.59 mg/L) = {(2.59 mg/L) x 1 L/(l x 103 m3)] = 2590 mg/m3. Assuming a 10 mVday inhalation rate
 (2590 mg/m3 x 10 mVday) / 70 kg = 370 mg/kg/day.
e Engineering controls were used: enclosed cockpit, single layer of clothing and no gloves.

                             (2)    Occupational Risk Characterization

       As can be seen from  Table  3, the dermal and inhalation MOEs for all exposure scenarios greatly
exceed 100.  Although the risk to  aerial applicators using open cabs or cockpits was not estimated, (the
Pesticide Handlers  Exposure Database does not contain sufficient data to estimate this exposure scenario),
the Agency does  not have  concern for these handlers since  the vast majority  of aerial application is
performed using aircraft with closed cabs and cockpits.  In addition, the  high margin of exposure for
open cab tractors also suggest that open cockpit exposures are not a concern.

       It has been  determined that there is a potential for exposure to persons entering treated sites after
application is complete and no post-application exposure data are available for mepiquat chloride.  Based
on the low maximum application rate of 0.044 pounds per acre and the high margins of exposure for
mixers/loaders/handlers, the Agency expects post-application risks to  be  very low.  In addition, post-
application  exposures are  further limited because  of the common practice of tank-mixing mepiquat
chloride with pesticides with longer Re-Entry  Intervals (REI). Therefore,  the Agency believes that the
risks from post-application  exposures to mepiquat chloride will not pose unreasonable risks to persons
entering treated areas.
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       Also, the Agency has reports of worker poisonings associated with mepiquat chloride.  There were
eight reported  incidents  involving mepiquat chloride in the California Pesticide Illness Surveillance
Program data base from 1982 through 1992. However, the circumstances of these incidents are not fully
known and may be attributable to exposure from other chemicals. For this reason, the Agency does not
consider these incidents to be indicative of any significant risk.

              5.     Food  Quality Protection Act (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 available 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 new section  408(b)(2)(C) says that, in the case  of threshold effects, EPA must apply an
additional 10-fold margin of safety for infants and children to take into accout potential pre- and post-
natal toxicity unless EPA concludes, based on reliable data, that a different margin of safety will  be safe
for 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 mepiquat chloride  is used on cotton, a crop  used as animal feed which has tolerances,
specific consideration of  the risks to infants  and children, as well as  aggregate exposures and potential
cumulative effects is warranted.

                     a.     Potential Risks to Infants and Children

       In determining whether an additional uncertainty factor is or is not appropriate for assessing risks
to infants and children, EPA uses a weight of evidence approach taking into account the completeness
and adequacy of the toxicity database, the nature of the effects observed in pre- and post-natal studies,
and other information such as epidemiological data.

       For the  purpose  of  assessing the  pre- and post-natal toxicity of mepiquat chloride, EPA  has
evaluated two developmental and one reproduction study. Based on current data requirements, these
three studies when considered along with other required toxicity studies, constitute a complete database
for evaluating pre- and post-natal effects  for food use chemicals. However,  the rabbit developmental
study was considered supplemental and a new  developmental study in rabbits is required as confirmatory


                                               22

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data.  Additionally, as EPA fully implements the requirements of FQPA, additional data related to the
special sensitivity of young organisms may be required.

       Developmental and Reproductive Effects

       The effects observed in the mepiquat chloride developmental and reproduction studies can be
summarized as follows:

       A developmental toxicity study with Wistar rats used doses of 0, 50, 150 or 300 mg/kg/day given
by gavage on gestation days  6-15.  The maternal toxicity NOEL was 150 mg/kg/day based on clinical
signs of toxicity, decreases in food consumption and reduced body weight gain.  The developmental
toxicity NOEL is >  300 mg/kg/day because no effects on any of the developmental toxicity parameters
were seen.  In addition, no embryotoxicity, fetotoxicity and no indications of any teratogenic effects were
observed in the  study.

       In a developmental toxicity study in Himalayan rabbits doses  of 0, 50, 100 and 150 mg/kg/day
was given by gavage on gestation days 6-18. The NOEL for maternal toxicity was 50 mg/kg/day mid-
and high-dose groups included weight loss, decreased body weight gain, deceased food consumption,
amber-color liquid in the  abdomens of two rabbits,  diarrhea, trembling,  apathy and abortion.  No
developmental effects were seen at the 50 mg/kg/day-dose group. The  developmental  LOEL is  100
mg/kg/day, based on the observed abortions. The abortions observed at 100 mg/kg/day were considered
evidence of developmental toxicity; however, due to the high abortion and death rates in the high dose
groups, an inadequate number of fetuses and available which precluded the meaningful evaluation of fetal
development in this study. Additionally, the fetal evaluation techniques used in the rabbit studies does
not permit full evaluation of potential effects.

       In  a two-generation reproduction study Wistar rats were fed doses of 0,  500, 1500 (147
mg/kg/day) or 5000 ppm (499 mg/kg/day) of mepiquat  chloride.  Treatment-related system effects were
seen only  in the highest dose group and were indicative of impaired neurological function (including
tremors and hypersensitivity  upon handling); to a lesser extent, effects to the high-dose group also
included decreased forelimb and hindlimb grip strength, reductions in relative food consumption, mean
body weight, and body weight gain.  The parental NOEL is 147 mg/kg/day.  The parental LOEL for
reproductive/systemic toxicity is 499 mg/kg/day based on neurological impairment, deceased body weight
gain in the adults and retarded growth  of Fl  and ^  pups.  The  reproductive NOEL is also  147
mg/kg/day.

       The developmental data for mepiquat chloride indicate developmental effects occurred at doses
that were the same as or higher than doses which  cause maternal toxicity.  The  Agency would generally
be concerned when developmental/ reproductive  effects are  seen at doses lower than those which cause
maternal effects.  Considering the nature of the developmental effects and the dose level at which they
occurred,  the developmental  studies in conjunction with the reproduction study  do not indicate  any
additional sensitivity of young organisms to mepiquat  chloride.
                                              23

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       Uncertainty Factor

       Based on the reliable data discussed above, and the absence of any incident or epidemiological data
for mepiquat chloride, the Agency concludes that an additional uncertainty factor is not warranted for the
mepiquat chloride chronic risk assessment, nor is the use of an additional uncertainty factor indicated for
estimating risk from acute exposures detailed below.

                    b.     Aggregate Exposure/Risk

       In examining aggregate exposure, FQPA directs EPA to take into account available information
concerning exposures from the pesticide residue in food and all other exposures for which there is reliable
information. These other sources of exposure include drinking water, and non-occupational exposures,
e.g., to pesticides used in  and around the home.  In addition to acute and chronic risks,  the Agency, as
appropriate, may also calculate risks for short-term and intermediate term exposures.

       Mepiquat chloride has no residential or other non-occupational uses that might result in exposures
to humans.   Neither a Maximum  Contaminant Level  (MCL) nor a Hazard Advisory  (HA) has been
established for mepiquat chloride. According to the EPA's Pesticides in Ground Water Database, there
have been no mepiquat chloride detections reported in monitoring wells.  Based on its  low application
rate, relatively rapid degradation rate, and soil binding ability, the Agency does not expect mepiquat
chloride to contaminate ground water or surface water. Consequently neither a chronic or acute drinking
water assessment was performed.

       Acute Risk

       The acute toxicity  of mepiquat chloride by the oral,  dermal, and inhalation routes of exposure is
very low.  An acute  dietary risk analysis was performed using tolerance-level residues and assumption
of 100 percent crop treated.  This analysis showed MOEs that were well above the Agency's level of
concern. MOE values ranged from 3,893 for infants to 29,200 for females 13+ years.

       Chronic Risk (Dietary Exposure)

       A chronic dietary exposure analysis was performed, using tolerance level residues and assuming
that 100 percent of the crops were  treated, to estimate the  Theoretical  Maximum Residue Contribution
(TMRC) for the general population and 22 subgroups.

       Existing tolerances result in a TMRC which represents <  1% of the RfD for the U.S. general
population and each of the 22 subgroups.

       The analysis for mepiquat chloride is  a worst case estimate of dietary exposure with all residues
assumed to be at tolerance levels and 100 percent of the  commodities assumed to  have been treated with
mepiquat chloride.
                                               24

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       Tolerances have been established in/on cottonseed at 2 ppm and animal commodities at 0.1 ppm.
The available data for mepiquat chloride support the established tolerances listed in 40 CFR § 180.384.
The tolerances for eggs, milk, poultry and byproducts will be proposed for revocation since data indicate
that no residues are likely in these commodities.  The tolerance for cotton forage will be proposed for
revocation since it is no longer considered a significant livestock feed.  The Section 409 tolerance for
cottonseed meal is not needed because any residue that may result in cottonseed meal as a result of
processing will be covered  by the reassessed  RAC tolerance.   The field residue data for cotton gin
byproducts have been required and a tolerance will be proposed for this commodity when adequate field
residue data have been submitted and reviewed.   These data are due to the Agency by March 17,  1997.
The  outcome of this  new  data  requirement  does not affect the  reregistration eligibility decision.
Additional tolerance revisions have been required.  Tolerances for residues of mepiquat in/on cotton
forage, cottonseed meal, eggs, milk, poultry fat, meat  and meat  byproducts  will be  proposed for
revocation.

       Conclusion Regarding Chronic Aggregate Exposure to Mepiquat Chloride

       Based on mepiquat chloride's use pattern as a growth regulator on cotton, no chronic residential,
other non-occupational or drinking water exposure is expected. Chronic aggregate exposure is limited
to dietary exposure which is expected to be < 1% of the RfD for the general  U.S.  population and the
22 population subgroups.  The Agency, therefore, concludes that aggregate risks to the general U.S.
population, and to the population subgroups of infants and children, resulting from mepiquat chloride uses
are not of concern.

                     c.      Cumulative Effects

       In assessing the potential risk from cumulative effects of mepiquat chloride and other pesticides
and substances with a common mode/mechanism of toxicity, the Agency first considered structural
similarities and common effects that exist between mepiquat chloride and other  related compounds such
as paraquat,  diquat and  difenzoquat.   The Agency then  considered other compounds which  could
potentially result in neurotoxic effects similar to mepiquat chloride.

       With one substance, difenzoquat, there appears to be similar neurotoxic effects. The Agency has
concluded that the cumulative effects from the  combined dietary exposure to mepiquat and difenzoquat
would be virtually nil because the chronic dietary exposure for all population subgroups  is less than 1%
of the RfD for both difenzoquat and mepiquat chloride.  The acute dietary MOE range for difenzoquat
is 50,000 to 16,000 while the acute dietary MOE range for mepiquat chloride  is 3,900 to 29,000.

       In evaluating other chemicals with neurotoxic effects similar to mepiquat chloride, the Agency
determined that it is unlikely that these other chemicals share a common mode/mechanism of toxicity with
mepiquat chloride, or that cumulative risk assessment would be required.  Although the mode/mechanism
of toxicity of mepiquat chloride has not been well defined, the effects noted on the nervous system appear
to be secondary to general systemic toxicity that occurs at high dose levels.  Based on available data and
structure-activity relationship analyses, mepiquat chloride would be considered  to  have  minimal
neurotoxic activity.


                                               25

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       C.      Environmental Assessment

               1.      Ecological Toxicity Data

                      a.      Toxicity to Terrestrial Animals

                             (1)     Birds, Acute

       An acute oral toxicity study using the technical grade of the active ingredient (TGAI) is required
to establish the toxicity of mepiquat chloride to birds.  The preferred test species is either mallard duck
(a waterfowl) or bobwhite  quail (an upland gamebird). Results of this test are presented in Table 4.
                                    Table 4: Avian Acute Oral Toxicity
Species
Northern bobwhite quail (Colinus virginianus)
Northern bobwhite quail (Colinus virginianus)
%ai
46
99
LDSO (ing/kg a, i.)
>2,134
> 2,000s
Toxicity Category
practically nontoxic
practically nontoxic
MRID No., Author/year
135130, Beavers et al. 19771
43150701, Munk, R. 19932
1 Supplemental (study is scientifically sound, but does not satisfy guideline.)  This study is supplemental because the birds were only 14 days old instead
of 16 weeks and the study was conducted for 8 days instead of 14.
2 Core (study satisfies guideline).
3 Onlyonebird death was reported during the study (at 2,000 mg/kg).

       The LD50 is  > 2000 mg/kg.  Therefore, mepiquat chloride is practically nontoxic to avian species
on an acute oral  basis.  The guideline (71-1) is fulfilled (MRID 43150701).

       Two  subacute dietary studies using the TGAI are required to establish the  toxicity of mepiquat
chloride to birds.  The preferred test species are mallard duck and bobwhite quail.  Results of these tests
are presented in  Table 5.

                                  Table 5: Avian Subacute Dietary Toxicity
Species
Northern bobwhite quail (Colinus virginianus)
Mallard duck (Anas platyrhynchos)
%ai
46
46
5-Day LC5(j (ppm
a.i.)
>4,6001
>4,6002
Toxicity Category
practically nontoxic
practically nontoxic
MRID No., Author/Year
135131, Beavers et al. 1977
135132, Beavers et al. 1977
 1 No deaths occurred at any dosage levels.
 2 Only one death occurred during the study (at 1,000 ppm).

       The LC50  is >4,600 ppm, therefore, mepiquat chloride is practically nontoxic to avian species
on a subacute dietary basis.  The guideline (71-2) is fulfilled (MRIDs  135131 and 135132).

                             (2)    Birds, Chronic

       Avian reproduction studies using  the TGAI are required when  birds may be subject to repeated
or continuous exposure to the pesticide.  Initial applications of mepiquat chloride  may coincide with bird
breeding; and when it may persist on avian food items in amounts that are potentially toxic on a chronic
basis.  The preferred test species are mallard duck and bobwhite quail.

       No avian  reproduction  studies are available for mepiquat chloride.  However, while mepiquat
chloride  meets the basic criteria for requiring avian reproduction studies, the relatively low application
                                                 26

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rate, and the indication of low biological activity to nontarget laboratory vertebrate species suggest that
the value-added of avian reproduction studies is low.  The peak maximum estimated residue level on
avian food  items  is 16  ppm for short grass.  This level is many times lower than acute avian and
mammalian  effect concentrations and chronic mammalian effect concentrations. The rat LD50 value is
464 mg/kg and the bobwhite quail LD50 value is > 2,000 mg/kg. Furthermore, mepiquat chloride poses
little acute,  chronic, or reproductive risk to mammals.  Therefore, these studies are not  required and
Guideline 71-4 is waived.
                            (3)
Mammals
       Wild mammal testing is required on a case-by-case basis, depending on the results of lower tier
laboratory mammalian studies,  intended use pattern and pertinent environmental fate characteristics.  In
most cases, the rat or mouse toxicity values substitute for wild mammal testing.  These toxicity values
are reported in III.B.I. above.

       Because the LD50 falls within the range of 51-500 mg/kg, mepiquat chloride is moderately toxic
to small mammals on an acute oral basis.  Chronic and subchronic studies indicate  that mammals are
affected at relatively high concentrations.
                            (4)
Insects
       A honey bee acute contact study using the TGAI is required for mepiquat chloride because its use
on cotton may result in honey bee exposure.  Results of this test are presented in Table 6.

                             Table 6: Nontarget Insect Acute Contact Toxicity
Species
Honey bee (Apis mellifera)
%ai
46.3
LDM (pig/bee)
> 100
Toxicity Category
practically nontoxic
MRIDNo., Author/Year
41626703, Hoxteretal. 1990
       The results indicate that mepiquat chloride is practically nontoxic to bees on an acute contact basis.
The guideline (141-1) is fulfilled (MRID 41626703).

                     b.     Toxicity to Aquatic Animals

                            (1)    Freshwater Fish

                                  (a)    Acute

       Two freshwater fish  toxicity studies  using the TGAI  are required to establish the toxicity of
mepiquat chloride to fish.  The preferred test species are rainbow trout (a coldwater fish) and bluegill
sunfish (a warmwater fish).  Results of these tests are presented in Table 7.
                                Table 7: Freshwater Fish Acute Toxicity
Species
Rainbow trout (Oncorhynchus mykiss) (static)
Rainbow trout (Oncorhynchus mykiss)
Bluegill sunfish (Lepomis macrochirus) (static)
%ai
99
46
99
96-hour LCSO (ppm a,i.)
(measured/nominal)
> 92 (measured)
730 (nominal)
> 89 (measured)
Toxicity Category
slightly toxic
practically nontoxic
slightly toxic
MRIDNo., Author/Year
41889006, Munk 19911
096636, Kueetal. 19771
41889005, Munk 1991
                                               27

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                                  Table 7: Freshwater Fish Acute Toxicity
Species
Bluegill sunfish (Lepomis macrochims)
%ai
46
96-hour LC5(j (ppm a.i.)
(measured/nominal)
2580 (nominal)
Toxicity Category
practically nontoxic
MRIDNo., Author/Year
096636, Kueetal. 1977
1 These studies are supplemental because the test concentration was less than 100 ppm but not high enough to produce mortality.

       The LC50 has been demonstrated in some tests to be  > 100 ppm, and therefore is considered to
be practically nontoxic to freshwater fish on an acute basis.  The guideline (72-1) is fulfilled (MRIDs
00135133, 41889005/6).

                                     (b)    Chronic

       A freshwater fish early life-stage test using the TGAI is required for mepiquat chloride because
the end-use product is expected to be transported to water from the  intended use site.  Based on available
use information, its presence in water  is likely to be continuous or recurrent.  Although the estimated
environmental concentration (0.82 ppb) resulting from its use is less than 0.01 of any acute LC50 or EC50
value, the aerobic  soil metabolism half-life ranges from 3-21 days and it is stable to hydrolysis and
photolysis. However, supplemental chronic toxicity studies with freshwater fish and invertebrates suggest
low chronic toxicity. Furthermore, mepiquat chloride's low acute toxicity and application rate suggests
that significant adverse chronic  effects  to aquatic organisms  are unlikely.  Therefore, a freshwater fish
study (GDLN 72-4) is  waived.

       The sublethal toxicity study presented in Table 8 below did not address the standard endpoints for
either the fish early-life stage or the fish full-life cycle studies.
               Table 8:  Freshwater Fish  Sublethal Toxicity Under Flow-through Conditions (28 days)
Species/ Study Duration
Rainbow trout (Oncorhynchus mykiss)
%Al
99.0
NOEC (ppm)
> 100 (nominal)
Endpoints Affected
none (growth, mortality, or toxic
symptoms)
MRIDNo., Author/Year
43155901, Munk, 1993
 This study is supplemental because juveniles and not embryos were used and the study duration was only 28 days instead of a minimum of 72 days.

                             (2)     Freshwater Invertebrates
                                    (a)
Acute
       A freshwater aquatic invertebrate toxicity test using the TGAI is required to establish the toxicity
of mepiquat chloride to aquatic invertebrates.  The preferred test species is Daphnia magna.  Results of
this test are presented in Table 9.
                               Table 9: Freshwater Invertebrate Acute Toxicity
Species
Waterflea (Daphnia magna)
Waterflea (Daphnia magna) (static test)
%ai
46
54.6
48-hour LCju/ECjj (ppm a.i.)
50.8
106 (measured)
Toxicity Category
slightly toxic
practically nontoxic
Acc./MRID No., Author/Year
00135134, Vilkasetal. 1977
43471001 Drottartetal. 1994
                                                 28

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       The LC50/EC50 falls in the range of > 10 to > 100 ppm, therefore, mepiquat chloride is slightly
to practically nontoxic to aquatic invertebrates on an  acute basis.   Guideline 72-2 is fulfilled (MRID
00135134).

                                   (b)    Chronic

       A freshwater aquatic invertebrate life-cycle test using the TGAI is required for mepiquat chloride
because  the end-use product is expected to be transported  to water from the intended use site and it is
intended for use such that its presence in water is likely to be continuous or recurrent.  Although the
estimated environmental concentration (0.82 ppb) resulting from its use is less than 0.01 of any acute
LC50  or  EQo value, the aerobic soil metabolism half-life ranges from 3-21 days, and  it is stable to
hydrolysis and photolysis.  The results using the preferred test species, Daphnia magna,  are presented
in Table 10.
                 Table  10: Freshwater Aquatic Invertebrate Life-Cycle Toxicity (Static Renewal)
Species
Waterflea (Daphnia
magna)
%ai
99
21-day NOEC/LOEC (ppm)
12.5/25 (nominal)
MATC1 (ppm)
18.8
Endpoints Affected
mortality of adults
MRID No., Author/Year
43155902, Elendt-
Schneider, 19932
1 Defined as the geometric mean of the NOEC and LOEC.
2 This study is supplemental because growth was not measured and extensive adult mortality occurred at 100 ppm.

       Supplemental chronic toxicity studies with freshwater fish and invertebrates suggest low chronic
toxicity.   Furthermore,  mepiquat chloride's low acute toxicity  and application  rate  suggests that
significant adverse  chronic effects  to  aquatic  organisms  are  unlikely.   Therefore, the freshwater
invertebrate study does not need to be repeated,  and Guideline 72-4 is satisfied.

                            (3)    Estuarine and Marine Animals

                                   (a)     Estuarine and Marine Fish, Acute

       Acute toxicity testing with estuarine/marine fish  using the TGAI is required for mepiquat chloride
because the end-use product  is expected to reach the marine/estuarine environment because of its use on
cotton in coastal counties.  The  preferred test species  is sheepshead minnow.  Results  of these tests are
presented in Table 11 below.
                         Table 11: Estuarine/Marine Fish  Acute Toxicity (Static Test)
Species
Sheepshead minnow (Cyprinodon variegatus)
%ai
54.6
96-hour LC5o (ppm a.i.)
> 1 5 1 (measured)
Toxicity Category
practically nontoxic
MRID No., Author/Year
43516701, Drottaretal. 1995
       The LC50 is > 100 ppm, therefore, mepiquat chloride is practically nontoxic to estuarine/marine
fish on an acute basis.  The guideline (72-3(a)) is fulfilled (MRID 43516701).

                                   (b)    Estuarine and Marine Fish, Chronic

       An estuarine/marine fish early life-stage test using the TGAI  is required for mepiquat chloride
because  the end-use  product  is expected to be transported  to water  from its use on cotton in coastal
                                                29

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counties.   Its  presence in water is likely to be  continuous  or recurrent.  Although the estimated
environmental concentration resulting from use is  less than 0.01 of any acute LC50 or EC50 value, the
aerobic soil metabolism half-life ranges from 3-21 days and it is stable to hydrolysis and photolysis. The
preferred test species is sheepshead minnow.  No chronic toxicity studies for estuarine and marine fish
are available for review.  However, supplemental chronic  toxicity studies with freshwater fish and
invertebrates suggest low chronic toxicity.  Furthermore, mepiquat chloride's low acute toxicity and
application  rate suggests that significant adverse  chronic effects to aquatic organisms are unlikely.
Therefore, the  estuarine/marine fish study (GDLN 72-4)  is waived.

                                   (c)    Estuarine and Marine Invertebrates, Acute

       Acute toxicity testing with estuarine/marine invertebrates using the TGAI is required for mepiquat
chloride because the end-use product is expected to reach the marine/estuarine environment because of
its use on cotton in coastal counties.  The preferred test species are  mysid shrimp and eastern  oyster.
Results of these tests are presented in Table 12.
                          Table 12: Estuarine/Marine Invertebrate Acute Toxicity
Species/Static or Flow-through
Eastern oyster (shell deposition or embryo-
larvae) (Crassostrea virginica) (flowthrough)
Mysid (Americamysis bahia) (static)
%ai.
54.6
54.6
96-hour LCso/ECso (ppma.i.)
12.6 (measured)
> 136 (measured)
Toxicity Category
slightly toxic
practically
nontoxic
MRID No. Author/Year
435167-02 Drottar et al. 1995
435167-03 Drottaretal. 1995
       The LC50/EC50 falls in the range of > 10 to  > 100 ppm, therefore, mepiquat chloride is slightly
to practically nontoxic to estuarine/marine invertebrates on an acute basis.  The guidelines  72-3b and 72-
3c are fulfilled (MRIDs 43516702 and 43516703).

                                   (d)     Estuarine and Marine Invertebrate, Chronic

       An estuarine/marine invertebrate life-cycle toxicity test using the TGAI is required for mepiquat
chloride because the end-use  product is expected to be transported to the estuarine/marine environment
from its use  on cotton in coastal counties. Its presence in water is likely to be continuous or recurrent.
Although the estimated environmental concentration resulting from use is less than 0.01 of any acute LC50
or EC50 value,  the aerobic soil metabolism half-life ranges from 3-21 days, and it is stable to hydrolysis
and photolysis. The preferred test species is mysid shrimp. No chronic toxicity studies for estuarine and
marine invertebrates are  available for review.  However, supplemental chronic  toxicity studies with
freshwater fish and invertebrates suggest low chronic toxicity.  Furthermore, mepiquat chloride's low
acute toxicity and application rate suggests that significant adverse chronic effects to aquatic  organisms
are  unlikely.  Therefore, an estuarine/marine invertebrate study is waived.

                     c.      Toxicity to Plants

                            (1)     Terrestrial

       Terrestrial plant testing (seedling emergence and vegetative vigor) may be required for a plant
growth regulator that has terrestrial non-residential outdoor use patterns and may move off the application
                                               30

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site through volatilization (vapor pressure _>^1.0 x 105mm Hg at 25°C) or drift (aerial), or that may have
endangered or threatened plant species associated with the application site.  Terrestrial plant testing is
required because mepiquat chloride is used as a plant growth regulator and application is by air or ground
to cotton.

       For seedling emergence and vegetative vigor, the following plant species and groups should be
tested: (1) six species of at least four dicotyledonous families,  one species of which is soybean  (Glycine
max), and the second of which is a root crop,  and (2) four species of at least two monocotyledonous
families, one of which is corn (Zea mays).

       Tier I tests measure the response of plants, relative to a control, at a test level that is equal to the
highest use rate  (expressed as Ibs ai/A).  Results of Tier 1 toxicity testing on the TGAI/TEP material are
presented in Table  13.
         Table 13: Nontarget Terrestrial Plant Seedling Emergence Toxicity (Tier I)1 MRID 41488109: Hughes, 1989
Species
Monocots:
Corn (Zea mays)
Ryegrass (Lolium spp.)
Oat (Avena sativa)
Onion (Allium cepa)
Dicots:
Soybean (Glycine max)
Lettuce (Lactuca sativa)
Cabbage (Brassica oleracea)
Carrot (Daucus carota)
Cucumber (Cucumis sativus)
Tomato (Lycopersicon esculentum)
% Response

-10
-13
-1
0

-8
0
-16
-5
2
-5
Endpoint affected2

height
height
height
emergence

weight
weight
emergence
height
emergence
emergence
1 47% TGAI tested at 0.25 Ibs ai/A.
2 The endpoint with the greatest inhibition level was tabulated for each species.
       For Tier  I  seedling emergence  cabbage  is the most sensitive dicot and ryegrass is the most
sensitive monocot.  The guideline (122-1) is fulfilled (MRID 41488109).
            Table 14: Nontarget Terrestrial Vegetative Vigor Toxicity (Tier I)1 MRID  41889008: deMonoch 1991
Species
Monocots:
Corn (Zea mays)
Ryegrass (Lolium spp.)
Oat (Avena sativa)
Onion (Allium cepa)
Dicots:
Soybean (Glycine max)
Lettuce (Lactuca sativa)
Cabbage (Brassica oleracea)
Carrot (Daucus carota)
Cucumber (Cucumis sativus)
Tomato (Lycopersicon esulentum)
% Response

-
-
-
-

-
-
-13
-11
-
-13
Endpoint affected2








dry weight
height

height
1 46.3% TGAI tested at 0.25 Ibs ai/A
2 Only significantly reduced endpoints were tabulated.
                                                  31

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       For Tier I vegetative vigor cabbage, tomato and carrots are the most sensitive dicots. No monocot
endpoints were significantly reduced.  The guideline (122-1) is fulfilled (MRID 41889008).

       Terrestrial Tier II studies are not required because a negative response equal to or greater than
25% was not observed in Tier I tests.

                            (2)     Aquatic

       Aquatic plant testing may be required on a case by case basis for a plant growth regulator that has
outdoor non-residential terrestrial uses that may move off-site by runoff (solubility > 10 ppm in water)
or by drift.  Results of Tier I  toxicity testing on the technical material are presented in Table 15.
                 Table 15: Nontarget Aquatic Plant Toxicity (Tier I)1  MRID 41488110: Hughes, 1989
Species
% Response
Endpoint affected
Vascular Plants
Duckweed (Lemna gibba)
+ 21.3
growth
Nonvascular Plants
Green algae (Selenastrum capricornutum)
Marine diatom (Skeletonema costatum)
Freshwater diatom (Navicula pelliculosa)
Blue-green algae (Anabaena flos-aquae)
+ 1.7
+ 0.8
-4.5
-14.4
growth
growth
growth
growth
 The test material was 47% a.i. (Technical) applied at 0.25 Ibs ai/A.

       The Tier I results indicate that blue-green algae is the most sensitive nonvascular aquatic plant
tested.  The guideline (122-2) is fulfilled (MRID  41488110).  Aquatic Tier II testing is not required
because the demonstrated effect levels were  < 50%.

              2.      Environmental Fate

                     a.      Environmental Fate Assessment

       This environmental fate  assessment is at  present  tentative.   It is based  on acceptable data
(hydrolysis;  photodegradation in  water;  aerobic  and  anaerobic   metabolism,  unaged  leaching,
adsorption/desorption, and terrestrial bare ground dissipation for vineyard use) and supplemental data
(photodegradation on soil).  Several  studies are of uncertain  value and, therefore, several environmental
fate data  requirements are not fulfilled.   Nevertheless, these studies provide adequate information to
assess the  environmental fate of mepiquat chloride.  Therefore, additional studies are not being required.

       The available data indicate that the major route of dissipation is microbial mediated processes to
C02 (aerobic soil metabolism half-lives »3 to 21 days).  However, mepiquat chloride does appear to be
stable  to  anaerobic metabolism  (no  half-life reported).  Other  laboratory data indicate  the mepiquat
chloride is stable to abiotic processes (hydrolysis and photolysis half-lives for pHs 3 to 9 = stable)  and
is  relatively non-mobile in sandy loam, loam, and clay loam soils (Kds=9.88,  12.0, and 25.0,
respectively). However, mepiquat chloride does appear to be mobile in sand soil (Kd = 0.22). Field data
of uncertain value for the lower cotton application rate supports the laboratory data (half-lives range from
3-21 days, with a longer half-life for the  California site, and discernible only in surface 0-6  inch  soil


                                                32

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depth).  However, acceptable field bare-ground data for the vineyard application rate indicates that half-
lives are longer for higher concentrations and/or are regional dependent (half-life for New York site =
6.5 days, half-lives for Washington and California sites =  71.9 and 87.2,  respectively).  Therefore,
mepiquat chloride appears to have a limited potential for movement to groundwater.  There is limited data
on mepiquat chloride metabolites. They appear to be transitory, never reaching > 5% of applied, and are
rapidly converted to C02.  In addition, based on the octanol/water coefficient and information from one
fish accumulation study, mepiquat chloride should not accumulate in fish.

                     b.    Environmental Fate and Transport

       These  environmental fate  and  transport data are based on data submitted since 1989 for
reregistration. Previously submitted data were not used by the registrant to  support reregistration.

                           (1)    Degradation

       The guideline hydrolysis study was found to be acceptable  to fulfill the data requirement (GDLN
161-1).  These hydrolysis data indicated that mepiquat chloride  is stable to  hydrolysis.  There was no
significant degradation at pH 3 to pH  9  (< 10% at all pHs tested).   Therefore, hydrolysis is not
considered a route of  dissipation (MRID 41488111).

       The  guideline photodegradation in  water study was found to be acceptable to fulfill the data
requirement (GDLN 161-2). These data indicate that mepiquat chloride is stable to photolysis and that
aqueous photolysis is not a route of dissipation for  mepiquat chloride.  There were no  discernible
mepiquat chloride degradates  (including C02)  during the testing period.  Recovery of applied parent
mepiquat chloride was >95% (MRID 41488112).

       The guideline photodegradation on soil study was found to be of uncertain value (supplemental)
and not acceptable to fulfill the data requirement (GDLN 161-2).  A discrepancy between the photolysis
control data and the aerobic soil metabolism data was not addressed. Although this study does not fulfill
the data requirement, repeating the photolysis  study would not  add any significant knowledge to the
current environmental fate database for this chemical. Therefore, a new study is not required.

       Even though there is still a concern with the photolysis study, the available data  indicate that soil
photolysis is not a route of degradation for mepiquat chloride.  Mepiquat chloride is considered stable
(no half-life calculated) to photolysis.  At the termination of the study, mepiquat chloride recovery in the
light  exposed samples  and the  dark control samples was  85.5% and 88.6%, respectively (MRIDs
41889009, 00127749, 42412103, and 43455801).

                           (2)    Metabolism

       The guideline  aerobic soil metabolism study was found to be acceptable.  The data requirement
(GDLN 162-1)  is fulfilled. Under aerobic conditions, mepiquat chloride at a concentration of 1 ppm
appears to degrade relatively rapidly (half-lives = 3 to 21 days)  to C02.  Potential metabolites like N-
methylpiperidine and  piperidine were not discernible during the  testing period at concentrations > 5%


                                               33

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of applied.  Therefore, they appear to be transitory and rapidly converted to C02 (MRIDs 43455801 and
42412103).

       The  guideline  anaerobic soil metabolism  study was found to be  acceptable, and  this data
requirement (GDLN 162-2) is fulfilled.  Under anaerobic conditions, mepiquat chloride was reported to
be stable.  There was no significant degradation of mepiquat chloride during the anaerobic testing period.
Therefore, no anaerobic soil metabolism half-life was reported (MRIDs 41889010 and  43455801).

                            (3)    Mobility

       The guideline mobility study was found to be scientifically valid and acceptable to partially fulfill
the data requirement (GDLN 163-1). The unaged  study indicated that mepiquat chloride is relatively non-
mobile.  Kds reported for sandy loam,  loam, and clay soils were 9.88, 12.0, and 25.0, respectively.
However,  mepiquat chloride does appear to be mobile in sand  (Kd  0.22).   Mobility data on aged
mepiquat chloride were not provided. Although this  study does not fulfill the data requirement, this data
would not add  significant knowledge to the current environmental fate  database for this chemical.
Therefore, a new study is not required (MRID 41488113).

                            (4)    Accumulation

       The  one guideline study was considered  supplemental.  However,  information  from the study,
when considered in combination with the Kow, fulfills the guideline requirement.  Mepiquat chloride is
not expected to accumulate in fish  (MRID 00136360).

                            (5)    Field Dissipation

       Two guideline studies were submitted to the Agency.   One study  is considered to be of uncertain
value, and the second study is acceptable for the bare-ground portion of the vineyard use and partially
fulfills the data requirement (GDLN 164-1).

       The  bare-ground data for the cotton use pattern are of uncertain value.  However, these data
indicate that mepiquat chloride degrades relatively rapid and is relatively non-mobile.  Half-lives of 3,
21, and 17 days were reported for Mississippi,  Texas, and California, respectively.  In addition, mepiquat
chloride was not detected below the 0-6 inch soil  segment except for one 6-12 inch soil segment sample
taken after the third application at the California test site.

       The vineyard bare ground study indicates that mepiquat chloride is relatively non-persistent under
the New York field conditions to moderately persistent under Washington  and California field conditions.
In addition, mepiquat chloride appears to be relatively non-mobile under all three field conditions.  Half-
lives for mepiquat chloride ranged from 6.5 to 87.2  days  for  the three sites, and mepiquat residues were
not detected  below the 0-6 inch  soil  depth except for two test samples during the  test periods.
Furthermore, these data indicate that higher mepiquat chloride application rates have longer half-lives
and/or that mepiquat chloride's persistence is region-dependent (MRIDs 42353301 and 43415401).
                                               34

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                     c.      Water Resources

                            (1)    Ground Water

       Even though binding strengths vary, mepiquat chloride appears to be relatively non-mobile in most
soils.  The Kds ranged from 9.88 for sandy loam, 12.0 for loam, to 25.0 for clay loam soils.  Field data
show  mepiquat chloride to be relatively non-mobile  (discernible only in  the top 0-6 inches soil depth).
       Because there are no mepiquat chloride metabolites that reach concentrations greater than 5% of
applied, parent mepiquat chloride is the only residue of concern.  The metabolites appear to be transitory
and rapidly convert to C02 (half-life =  3 to 21 days).

       In addition, there have  been  no mepiquat chloride detections reported in monitoring wells1.
Therefore, based on its low application rate (0.022 to  0.44 Ib ai/A or 0.132 Ib a.i./A/season), relatively
rapid degradation rate, and soil binding ability, mepiquat chloride is considered to have a limited potential
for ground water  contamination.   However, if mepiquat chloride reaches  anaerobic conditions and
becomes stable, the chance for movement to  lower soil profiles may increase.

                            (2)    Surface Water

       Even though there are  no  detections reported in surface water (Storet database), mepiquat chloride
does have the potential to contaminate surface water.  Mepiquat chloride adsorbs to sediment (Kds vary
for soil textures, i.e., 9.88 for  sandy loam,  12.0 for  loam, and 25.0 for clay loam soils) and is very
soluble in water.  Therefore,  mepiquat chloride contamination of surface water is possible from runoff
of both dissolved and soil bound mepiquat chloride.  The lack of detections may be explained by other
environmental fate data (metabolism), which indicate that mepiquat chloride should degrade relatively
rapidly (aerobic half-life = 3-21 days) in surface water.

       Parent mepiquat chloride is the only residue of concern. Mepiquat chloride metabolites appear
to be transitory and rapidly convert to C02. This rapid conversion apparently results in the metabolites
never reaching  concentrations greater than 5% of applied mepiquat chloride.

             3.     Ecological Exposure and Risk Characterization

       Risk characterization integrates  the results of the exposure and ecotoxicity data to evaluate the
likelihood of adverse ecological effects. The means of integrating the results of exposure and  ecotoxicity
data is called the quotient method.  For this method,  risk quotients (RQs)  are  calculated by  dividing
exposure estimates by ecotoxicity values, both acute and chronic.
       1   EPA Pesticides in Ground Water Database - A compilation of Monitoring Studies:
          1971-1991 National Summary put out by the EPA
                                               35

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       RQ =  EXPOSURE/TOXICITY

       RQs are then compared to the Agency's levels of concern (LOCs).  These LOCs are criteria used
by the Agency to indicate potential risk to nontarget organisms and the need to consider regulatory action.
The criteria indicate that a pesticide used as directed has the potential to cause adverse effects on
nontarget organisms. LOCs currently address the following risk presumption categories: 1) acute high -
potential for acute  risk is high, regulatory action may be warranted in addition  to restricted use
classification, 2) acute restricted use - the potential for acute risk is high, but this may be mitigated
through restricted use classification, 3) acute endangered species -  the potential  for acute risk to
endangered species is high, regulatory action may be warranted, and 4)  chronic risk - the potential for
chronic risk is high, regulatory action may be warranted.   Currently,  the Agency does not  perform
assessments for chronic risk to plants, acute or chronic risks to nontarget insects,  or chronic risk from
granular/bait formulations to mammalian or avian species.

       The  ecotoxicity test values  (i.e., measurement endpoints) used  in the acute and chronic risk
quotients are derived from the results of required studies.  Examples of ecotoxicity values derived from
the results of short-term laboratory studies that assess acute effects are: 1)  LC50 (fish and birds), 2) LD50
(birds and mammals, 3) EC50 (aquatic plants and aquatic invertebrates), and 4) EC25 (terrestrial plants).
Examples of toxicity test effect levels derived from  the results of long-term laboratory studies that assess
chronic effects are: 1) LOEC (birds, fish, and aquatic invertebrates), 2) NOEC (birds, fish and aquatic
invertebrates), and 3) MATC (fish and aquatic invertebrates).  For birds and mammals, the NOEC value
is used as the ecotoxicity test value in assessing chronic effects.  Other values may be used when justified.
Generally, the MATC (defined as the geometric  mean of the NOEC and LOEC) is used as the ecotoxicity
test value in assessing chronic effects to  fish and aquatic invertebrates.  However,  the NOEC is used if
the measurement endpoint is production of offspring or survival.

       Risk presumptions, along with the corresponding RQs and  LOCs are presented in Table 16.
                            Table 16: Risk Presumptions for Terrestrial Animals
Risk Presumption
RQ
LOC
Birds
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
EECVLC50 or LD50/sqft2 or LD50/day3
EEC/LC50 or LD50/sqft or LD50/day (or LD50 < 50 mg/kg)
EEC/LC50 or LD50/sqft or LD50/day
EEC/NOEC
0.5
0.2
0.1
1
Wild Mammals
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
EEC/LC50 or LD50/sqft or LD50/day
EEC/LC50 or LD50/sqft or LD50/day (or LD50 < 50 mg/kg)
EEC/LC50 or LD50/sqft or LD50/day
EEC/NOEC
0.5
0.2
0.1
1
  abbreviation for Estimated Environmental Concentration (ppm) on avian/mammalian food items

   mg/ft2       3 	EEC	
                LD50/proportion of bodyweight consumed
                                                36

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                             Table 17: Risk Presumptions for Aquatic Animals
Risk Presumption
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
RQ
EECVLC50 or EC50
EEC/LC50 or EC50
EEC/LC50 or EC50
EEC/MATC or NOEC
LOG
0.5
0.1
0.05
1
  EEC = (ppm or ppb) in water
                                  Table 18: Risk Presumptions for Plants
Risk Presumption
RQ
LOG
Terrestrial and Semi- Aquatic Plants
Acute High Risk
Acute Endangered Species
EECVEC25
EEC/EC05 or NOEC
1
1
Aquatic Plants
Acute High Risk
Acute Endangered Species
EEC2/EC50
EEC/EC05 or NOEC
1
1
 EEC = Ibs ai/A
 EEC = (ppb/ppm) in water
                     a.     Exposure and Risk to Nontarget Terrestrial Animals
       For pesticides applied as a nongranular product (e.g., liquid, dust), the estimated environmental
concentrations (EECs) on food items following product application are compared to LC50 values to assess
risk.  The predicted 0-day maximum and mean residues of a pesticide that may be expected to occur on
selected avian or mammalian food items immediately following a direct single application at 1  Ib ai/A
are presented in Table  19.
   Table 19: Estimated Environmental Concentrations on Avian and Mammalian Food Items (ppm) Following a Single
                                        Application at 1 Ib ai/A.
Food Items
Short grass
Tall grass
Broadleaf/forage plants, and small insects
Fruits, pods, seeds, and large insects
EEC (ppm) Predicted Maximum Residue1
240
110
135
15
EEC (ppm) Predicted Mean Residue
85
36
45
7
1 Predicted maximum and mean residues are for a 1 Ib ai/A application rate and are based on Hoerger and Kenaga (1972) as modified by Fletcher et al.
(1994).

       Mepiquat chloride (N,N-dimethylpiperidinium chloride) is a plant growth regulator.  It inhibits
gibberellic acid synthesis, reduces internodal length, hastens maturity, retards abscission, and increases
yield potential.  It is registered for use on cotton.  At post emergence, it may be applied  one or more
times (spray or ultra low volume) by aircraft or ground equipment at 0.022 Ibs ai/A to 0.044 Ibs ai/A
(not to exceed 0.132 Ibs ai/A/season).

       Predicted residues (EECs) resulting from multiple applications are calculated in various ways.
For mepiquat chloride,  the EECs  are based  on the maximum application rate and assuming  no
degradation.
                                                 37

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                            (1)    Birds

       The acute risk quotients for a single broadcast application of mepiquat chloride are presented in
Table 20.

  Table 20: Avian Acute Risk Quotients for a Single Application of Mepiquat Chloride Based on a Bobwhite Quail LC50
                                           of 4,600 ppm.
Site/ Application Method
Cotton/broadcast
aerial or ground
Applic. Rate
(Ibs ai/A)
0.044
Food Items
Short grass
Tall grass
Broadleaf plants/Insects
Seeds
Maximum EEC
(ppm)
11
5
6
1
T r
-"^^50
(ppm)
>4600
>4600
>4600
>4600
Acute RQ
(EEC/LC50)
<0.01
<0.01
<0.01
<0.01
       The results indicate that for a single broadcast application of mepiquat chloride, no avian acute
levels of concern are exceeded at the registered maximum application rate of 0.044 Ib ai/A.

       The acute risk quotients for multiple broadcast applications of mepiquat chloride are presented
in Table 21.

  Table 21: Avian Acute Risk Quotients for Multiple Applications of Mepiquat Chloride Based on a Bobwhite Quail LC50
                                            of 4600 ppm.
Site/Application
Method
Cotton/broadcast
aerial or ground
Application Rate (Ibs
ai/A/season)
0.132
Food Items
Short grass
Tall grass
Broadleaf plants/Insects
Seeds
Maximum EEC1 (ppm)
32
14
18
2
LC5o
(ppm)
4600
4600
4600
4600
Acute RQ
(EEC/LCSO)
<0.01
<0.01
<0.01
<0.01
1 EEC is based on Fletcher et al. (1994) without degradation.

       The results indicate that for multiple broadcast applications of mepiquat chloride, no avian acute
level of concern is exceeded at 0.132 Ibs ai/A/season.
                            (2)
Mammals
       Estimating the potential for adverse effects to wild mammals is based upon the Agency's draft
1995 SOP of mammalian risk assessments and methods used by Hoerger and Kenaga (1972) as modified
by Fletcher  et al. (1994).  The concentration of  mepiquat chloride in the diet that is expected to be
acutely lethal to 50% of the test population (LC50) is determined by dividing the rat LD50 value by the
proportion of body weight consumed.  A risk quotient is then determined by dividing the EEC by this
value.  Risk quotients are calculated for three separate weight classes of mammals (15, 35, and  1000 g),
each presumed to consume four different kinds of food (grass, forage, insects, and seeds).  The acute risk
quotients for broadcast applications of mepiquat chloride are presented in Table 22.
                                                38

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   Table 22: Mammalian (Herbivore/Insectivore) Acute Risk Quotients for Broadcast Aerial or Ground Applications of
                            Mepiquat Chloride Based on a the Rat LD50 of 464 mg/kg.
Site/Rate
(Ibs ai/A)
Body
Weight
<8>
%Body
Weight
Consumed
Rat
LD50
(mg/kg)
EEC
(ppm)
Short
Grass
EEC (ppm)
Forage &
Small Insects
EEC (ppm)
Large
Insects
Acute RQ1
Short
Grass
Acute RQ
Forage
& Small Insects
Acute RQ
Large
Insects
Cotton (single application)
0.044
0.044
0.044
15
35
1000
95
66
15
464
464
464
11
11
11
6
6
6
1
1
1
0.02
0.02
0.01
0.01
0.01
<0.01
<0.01
<0.01
<0.01
Cotton (multiple applications)2
0.132
0.132
0.132
15
35
1000
95
66
15
464
464
464
32
32
32
18
18
18
2
2
2
0.07
0.04
0.02
0.04
0.02
<0.01
<0.01
<0.01
<0.01
  RQ     EEC (ppm)
        LD50 (mg/kg)/proportion of bodyweight consumed
  EEC based on Fletcher et al. (1994) without degradation.

  Table 23: Mammalian (Granivore) Acute Risk Quotients for Applications of Mepiquat Chloride Based on a Rat LD50 of
                                                 464 mg/kg.
Site/ Application Rate
(Ibs ai/ A/season)
Body
Weight (g)
% Body Weight
Consumed
Rat LDSO
(mg/kg)
EEC (ppm)
Seeds
Acute RQ1
Seeds
Cotton/broadcast aerial or ground (multiple applications)2
0.132
0.132
0.132
15
35
1000
21
15
3
464
464
464
2
2
2
<0.01
<0.01
<0.01
               EEC (ppm)
1 RQ = 	
       LD50 (mg/kg)/proportion of body weight consumed
2 EEC based on Fletcher et al. (1994) without degradation.

       The results indicate that for broadcast applications of mepiquat chloride, no mammalian acute
levels of concern are exceeded at 0.132 Ibs ai/A/season.

  Table 24: Mammalian Chronic Risk Quotients for Multiple Applications of Mepiquat Chloride (Based on a Dog NOEL
                                  of 1000 ppm in a Subchronic Toxicity Study)
Site/Application
method
Cotton/Broadcast
aerial or ground
Application Rate in Ibs
ai/A/season
0.132
Food Items
Short grass
Tall grass
Broadleaf plants/Insects
Seeds
Maximum EEC1
(ppm)
32
14
18
2
NOEC (ppm)2
1000
1000
1000
1000
Chronic RQ
(EEC/NOEC)
0.03
0.01
0.02
<0.01
1 Based on Fletcher without degradation.
2 Based on clinical signs of toxicity at 3000 ppm, including: slight sedation, slight attacks of tonoclonic spasms, inhibition of body weight,
 hematological effects, number of erythrocytes, and reduced hematocrit.

        The results indicate that for multiple broadcast applications of mepiquat chloride, the mammalian
chronic level of concern is not exceeded at 0.132 Ibs ai/A/season.

                       b.      Exposure and Risk to Nontarget Aquatic Animals

        The Agency calculates EECs using the GENeric Expected Environmental Concentration program
(GENEEC).  The  EECs are used for assessing acute and chronic risks to  aquatic organisms.  Acute risk
                                                    39

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assessments are performed using peak EEC values for single and multiple applications.  Chronic risk
assessments are performed using the 21-day EECs for invertebrates and 56-day EECs for fish.

       The GENEEC  program uses  basic environmental fate data and pesticide label  application
information  to  estimate  the  EECs following  treatment  of 10 hectares.  The model calculates the
concentration (i.e. EEC)  of a pesticide in a one hectare, two meter deep pond, taking into  account the
following: 1)  adsorption to soil or sediment, 2) soil incorporation, 3) degradation in soil before wash-off
to a water body, and 4) degradation within the water body. The model also accounts for direct deposition
of spray drift into the water body  (assumed to be  1% and 5% of the application rate for ground and aerial
applications, respectively).  (When multiple applications are permitted, the interval between applications
is included in the calculations.)  The environmental fate parameters used in the model for this pesticide
are: soil Koc is 1168; solubility is 500,000 ppm; aerobic soil metabolism half-life is 21  days; hydrolysis -
stable; water photolysis - stable; and theoretical aquatic metabolism (based on the aerobic soil  metabolism
half-life of 21 days) is 42 days.  EECs are presented in Table 25.
   Table 25: Estimated Environmental Concentrations (EECs)  For Aquatic Exposure Following Multiple Applications
Site
Application
Method
Application Rate
(Ibs ail A/season)
Initial (PEAK) EEC
(ppb)
21-day average
EEC (ppb)
56-day average
EEC (ppb)
GENEEC
Cotton
Cotton
broadcast aerial
broadcast ground
0.132
0.132
1.64
1.44
1.20
1.04
0.78
0.68
                            (1)
Freshwater Fish
       Acute risk quotients are presented in Table 26.

   Table 26: Freshwater Fish Acute Risk Quotients for Multiple Applications of Mepiquat Chloride based on a Bluegill
                                       Sunfish LC50 of 730 ppm.
Site/Application Method/Rate (Ibs ai/ A/season)
Cotton/broadcast aerial (0.132)
Cotton/broadcast ground (0.132)
LCSO (ppma.i.)
730
730
EEC Initial/Peak (ppb)
1.64
1.44
Acute RQ (EEC/LC50)
<0.01
<0.01
       The results indicate that no acute levels of concern are exceeded for freshwater fish at the 0.132
Ibs ai/A/season application rate.
                            (2)
Freshwater Invertebrates
       The acute and chronic risk quotients are presented in Table 27.

  Table 27: Freshwater Invertebrate Acute and Chronic Risk Quotients for Multiple Applications of Mepiquat Chloride
                     Based On a Daphnia magna LC50 of 50.8 ppm and NOEC of 12.5 ppm.
Site/ Application method/Rate (Ibs
ai/A/season)
Cotton/aerial (0.132)
Cotton/ground (0.132)
LC50 (ppm
a.i.)
50.8
50.8
NOEL (ppm
a.i,)
12.5
12.5
EEC Initial/
Peak (ppb)
1.64
1.44
21-Day Avg.
EEC (ppm)
1.20
1.04
Acute RQ
(EEC/LCJ
<0.01
<0.01
Chronic RQ
(EEC/NOEC
<0.1
<0.08
       The results indicate  that no  acute  or  chronic levels of concern are  exceeded for freshwater
invertebrates at 0.132 Ibs ai/A/season.
                                                40

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                            (3)    Estuarine and Marine Animals

                                   (a)    Estuarine and Marine Fish

       The acute risk quotients are presented in Table 28.
  Table 28: Estuarine and Marine Fish Acute Risk Quotients for Multiple Applications of Mepiquat Chloride Based on a
                                  151 ppm LC50 for Sheepshead Minnow.
Site/ Application Method
Cotton/broadcast aerial
Cotton/broadcast ground
Rate (Ibs ai/A/season)
0.132
0.132
LC50 (ppm a.i.)
151
151
EEC Initial Peak (ppb)
1.64
1.44
Acute RQ (EEC/LC50)
0.01
0.01
       The results indicate that no acute levels of concern are exceeded for estuarine/marine fish at the
0.132 Ib ai/season application rate.
                                   (b)
Estuarine and Marine Invertebrates
       The acute risk quotients are presented in Table 29.

   Table 29: Estuarine and Marine Invertebrate Acute Risk Quotients for Multiple Applications of Mepiquat Chloride
                              Based on an Eastern Oyster LC50 of 12.6 ppm.
Site/ Application Method
Cotton/broadcast aerial
Cotton/broadcast ground
Rate in Ibs ai/A/season
0.132
0.132
LCSO (ppm a.i.)
12.6
12.6
EEC Initial/Peak (ppb)
1.64
1.44
Acute RQ (EEC/LC50)
0.13
0.11
       The results indicate that endangered species acute levels of concern are exceeded for estuarine
invertebrates at 0.132 Ibs ai/A season. Although numerical values are exceeded, at the present time there
are no federally listed endangered estuarine or marine invertebrates.

                     c.     Exposure and Risk to Nontarget Terrestrial and Semi-Aquatic Plants

       Terrestrial  and semi-aquatic plants may be exposed to pesticides from runoff, spray drift or
volatilization.   Semi-aquatic plants are those that inhabit low-lying wet areas that may be dry at certain
times of the year.  However,  no Tier  I plant toxicity studies demonstrated an EC25 (tested at 0.25 Ibs
ai/A).  These results indicate that acute levels of concern are not exceeded for nontarget plants at the 0.25
Ibs ai/A application rate.

       Product labels indicate that mepiquat chloride is applied to cotton during flowering stages. Off-
target drift may affect the reproductive stages of nontarget plants (including adjacent crops).  Therefore,
additional studies evaluating adverse effects to reproductive stages may be required in the  future pending
the results of ongoing plant guideline harmonization efforts.

                     d.     Endangered Species

       Endangered species  LOCs were  exceeded  for estuarine invertebrates  for mepiquat chloride.
However,  at the present time,  there are no  federally listed estuarine invertebrates.
                                                41

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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 ingredient are  eligible for
reregistration.  The Agency has previously identified and required the submission of the generic (i.e.
active ingredient specific) data required to support reregistration of products containing mepiquat chloride
as an active ingredient.  The Agency has completed its review of these generic data, and has determined
that the data  are  sufficient to support reregistration of all products containing mepiquat chloride.
Appendix B  identifies the generic data requirements that the Agency reviewed as part of its determination
of reregistration eligibility of mepiquat chloride, and lists the submitted studies that the Agency found
acceptable.

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

       The  Agency made its reregistration  eligibility determination based  upon the target  database
required for  reregistration, the current guidelines for conducting acceptable studies to generate such data,
published scientific literature, etc. and the data identified  in Appendix B. Although the Agency has found
that all uses of mepiquat chloride are eligible for reregistration, it should be understood that the Agency
may take appropriate regulatory action, and/or require the submission of additional data to support the
registration of products containing mepiquat chloride, 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

       The Agency has determined that mepiquat chloride products, labeled and used as specified in this
Reregistration Eligibility Decision,  will not pose unreasonable risks or adverse effects  to humans or the
environment. In reassessing mepiquat chloride cotton tolerances under the Food Quality Protection Act
of 1996, the  Agency has determined that there is a reasonable certainty  that no harm will result to infants,
children or any general population subgroups from aggregate exposure to mepiquat chloride. There are
no other uses of mepiquat chloride that present risks of dermal or inhalation exposure to infants,  children
or  the general population.  Additionally, mepiquat chloride  has not been found in drinking water.
Structural similarities exist between mepiquat chloride and difenzoquat and there appears to be similar
neurotoxic effects. The Agency concludes that cumulative effects would be virtually nil from dietary
exposure to mepiquat chloride and difenzoquat. The acute dietary MOEs for  all populations including
infants  and children for both mepiquat chloride and difenzoquat are well above the Agency's level of


                                               42

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concern and the chronic dietary exposures for all population subgroups are less than 1% of the RfD.
Cumulative effects would also be virtually nil for workers exposed to mepiquat chloride and difenzoquat.
Therefore, the Agency concludes that products containing mepiquat chloride for the current use on cotton
are eligible for reregistration.

              2.     Eligible and Ineligible Uses

       The Agency has determined that the currently registered use of mepiquat chloride on cotton is
eligible for reregistration.

       C.     Regulatory Position

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

              1.     Food Quality Protection Act Findings

                    a.      Determination of Safety for U.S. Population

       EPA has determined that the established tolerances for mepiquat chloride meet the safety standards
under  the FQPA amendments to section 408(b)(2)(D) for  the general population.  In reaching this
determination, EPA  has considered the available information on the aggregate exposures (both acute and
chronic) from the feed  use  on cotton, as  well as the possibility of cumulative effects from mepiquat
chloride and other chemicals with a similar mode/mechanism of toxicity.

       Since there are no residential or lawn uses of mepiquat chloride, no dermal or inhalation exposure
is  expected in and around the home.  No  acute toxicity endpoints of concern have  been identified for
mepiquat chloride.

       In assessing chronic dietary risk, EPA estimates that mepiquat chloride residues in food account
for <  1% of the RfD and residues in drinking water are not expected. Thus, the aggregate exposures
from all sources of mepiquat chloride (in this case, only dietary is relevant) account for < 1% of the RfD
for the general population.   Therefore, the Agency  concludes that aggregate risks for the general
population resulting from  mepiquat chloride uses are not of concern.

       In evaluating the potential for cumulative effects, EPA compared structural similarities and toxic
effects seen in mepiquat chloride studies with other related compounds.  With one substance, difenzoquat,
there appears to be similar  neurotoxic effects.  However, the Agency has concluded that the cumulative
effects from the combined dietary  exposure to mepiquat chloride and difenzoquat would be virtually nil
because the chronic dietary exposure  for all population subgroups is less than 1% of the RfD for both
difenzoquat and mepiquat chloride.
                                               43

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                     b.     Determination of Safety for Infants and Children

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

       In determining whether or not infants and children are particularly susceptible to toxic effects from
mepiquat chloride residues, EPA considered the completeness of the database for developmental and
reproductive effects as well as other relevant toxicity studies, the nature of the effects observed, and other
information.

       Based on the current data requirements, mepiquat chloride has a substantially complete database
for developmental and reproductive toxicity. However, the rabbit developmental study was considered
supplemental.  A  new developmental study in rabbits is being required as confirmatory data.   In the
developmental studies effects were seen in the fetuses only at the same or higher dose levels than effects
on the mothers. In the reproduction study,  no effects on  reproductive performance were seen.  Also,
because the  NOELs from the developmental and reproduction studies were equal to or greater than the
NOEL used for establishing the reference dose, EPA concludes that it is unlikely that there is additional
risk  concern for immature or developing organisms.  Finally,  the  Agency has  no epidemiological
information suggesting special sensitivity of infants and children to mepiquat chloride.  Therefore, EPA
finds that the  uncertainty factor (100X) routinely used in  RfD calculations is adequately protective of
infants and children, and an additional uncertainty  factor is not warranted for mepiquat chloride.

       EPA estimates that mepiquat chloride  residues in the diet of infants and children account for less
than  1% of the RfD  and residues in drinking water  are  not expected.  Thus, the chronic aggregate
exposure from all sources of mepiquat chloride account for less than 1% for infants and children. The
acute dietary  MOE for infants and children exposed to mepiquat chloride is 3,893.  Therefore, the
Agency concludes that aggregate risks for infants and children resulting from mepiquat chloride uses are
not of concern.

       In  deciding to continue 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 to its regulatory determinations.  Rather, these early
decisions will be made on a case-by-case basis and will not bind EPA as it proceeds with further policy
development and rulemaking that may be required.

       If EPA determines, as a result of this later implementation process, that any of the determinations
described in this RED are no longer appropriate, the Agency will consider itself free to pursue whatever
action may be appropriate, including but not limited to, reconsideration of any portion of this RED.
                                               44

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          2.
Tolerance Reassessment
   A summary of mepiquat chloride tolerance reassessments is presented in Table 30 below.

                      Table 30:  Tolerance Reassessment Summary for Mepiquat Chloride
Commodity
Current
Tolerance
(ppm)
Tolerance
Reassessment
(ppm)
Comment/ [Correct Commodity Definition]
Tolerances Listed Under 40 CFR §180.384:
Cotton forage
Cottonseed
Eggs
Cattle, fat
Cattle, mbyp
Cattle, meat
Goats, fat
Goats, mbyp
Goats, meat
Hogs, fat
Hogs, mbyp
Hogs, meat
Horses, fat
Horses, mbyp
Horses, meat
Milk
Poultry, fat
Poultry, mbyp
Poultry, meat
Sheep, fat
Sheep, mbyp
Sheep, meat
3
2
0.05
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.05
0.1
0.1
0.1
0.1
0.1
0.1
Revoke
2
Revoke
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
Revoke
Revoke
Revoke
Revoke
0.1
0.1
0.1
Not considered a significant livestock feed item (Table II, 9/95).
[Cotton, undelinted seed]
40 CFR 180.6(a)(3) [Category 3] situation












40 CFR 180.6(a)(3) [Category 3] situation
40 CFR 180.6(a)(3) [Category 3] situation
40 CFR 180.6(a)(3) [Category 3] situation
40 CFR 180.6(a)(3) [Category 3] situation



Tolerance That Needs To Be Proposed Under 40 CFR §180.384
Cotton gin
byproducts
N/A1
TBD2
A tolerance must be proposed for this commodity when adequate field
residue data have been submitted and evaluated.
Tolerance Listed Under 40 CFR §186.2275(a):
Cottonseed
meal
3.0
Revoke
Any residue that may result in cottonseed meal as a result of processing
will be covered by the reassessed RAC tolerance.
 1      N/A = not applicable
 2      TBD = to be determined.

              3.      Tolerance Revocations and Import Tolerances

       As part of EPA's reregistration eligibility decision for mepiquat chloride, food additive
tolerances are no longer needed.   Under FQPA, residues on processed food/feed items will be
regulated under FFDCA §408. Once a pesticide use is no longer registered in the United States,
the related pesticide residue tolerance and/or food/feed additive regulation generally is no longer
needed.   It is EPA'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.  EPA has the responsibility under the Federal
                                            45

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Food, Drug, and Cosmetic Act (FFDCA) to revoke a tolerance/regulation on the grounds that the
Agency cannot conclude that the tolerance/regulation is protective of the public health.

       The Agency recognizes, however, that interested parties may want to retain a tolerance
and/or food/feed additive  regulation 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 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 and/or
food/feed regulation.  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 and/or regulation.   Additional guidance on the Agency's import
tolerance policy will be published in  an upcoming Federal Register Notice.

       Parties  interested in supporting  an  existing mepiquat chloride  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  and regulations, so that the Agency may determine whether
maintenance of the tolerance  and/or regulation would be protective of the public health.

              4.     Specific Tolerance Reassessment Actions

       The tolerances listed in 40 CFR  §180.384, 40 CFR §185.2275 (a), (b), and (c), and 40
CFR   §186.2275(a)   and   (b)    are   expressed   in    terms  of  mepiquat    chloride
[N,N-dimethylpiperidinium].

                    a.      Cotton Forage (listed under 40 CFR §180.384)

       Cotton forage is no longer considered a significant livestock feed item and has been deleted
from Table II of the Pesticide Assessment Guidelines (Subdivision 0, Residue Chemistry,  issued
9/95).  Therefore, the established tolerance for cotton forage will be proposed for  revocation.

                    b.     Meat, Milk, Poultry and Eggs (listed under 40 CFR §180.384)

       The data indicate that tolerances for  ruminant  tissue are sufficient. The established
tolerances of 0.1 ppm for mepiquat residues in fat, meat, and meat byproducts of cattle, goats,
hogs, horses, and sheep are adequate. Pursuant to 40 CFR 180.6(a) (3), milk, poultry and egg
tolerances will be proposed  for revocation since data indicate that no residues are likely in these
commodities.
                                           46

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                    c.      Cotton Gin Byproducts (needs to be proposed under 40 CFR
                           §180.384)

       Table II  (issued 9/95)  now recognizes  cotton gin byproducts  as  a  raw agricultural
commodity of cotton.  Therefore, the Agency has already required that field residue data
must be submitted by the registrants before March 18, 1997 for cotton gin byproducts and
a tolerance must be proposed for this commodity when adequate field residue data have been
submitted and evaluated.

                    d.     Cottonseed Meal (listed under 40 CFR §186.2275 (a)

       A Section 409 tolerance is not needed for cottonseed meal. Any residue that may result
in cottonseed meal as a result of processing will be covered by the reassessed RAC tolerance.
Therefore, the established feed additive tolerance of 3.0 ppm for cottonseed meal will be proposed
for revocation.

             5.     CODEX Harmonization

       No maximum residue limits  (MRLs) for mepiquat chloride have been established by Codex
for any agricultural commodity.  Therefore, no compatibility questions  exist with respect to U.S.
tolerances.

             6.     Tolerance Reassessment Conclusions with Respect to  FQPA

       Determination of Safety for Mepiquat Chloride

       The Agency has reassessed the mepiquat chloride cotton related tolerances under the
standards of FQPA and determined that, based on available information, there is a reasonable
certainty that no harm will result to infants and  children from aggregate exposure to mepiquat
residues.  The only type of exposure evaluated was dietary, since mepiquat chloride has not been
found in drinking water and no non-food use exposure is expected.

             7.     Labeling Rationale/Risk Mitigation: Occupational

       All mepiquat chloride products  are intended primarily for occupational use.

                    a.     Personal Protective Equipment for Handlers  (Mixers, Loaders,
                           Applicators, etc.)

       As a result  of the  reregistration evaluation of the acute and other adverse effects of
mepiquat  chloride, the Agency has determined  that risks to handlers do  not warrant  the
establishment of active-ingredient-based  minimum personal protective equipment or engineering-
control requirements that would apply to all  mepiquat chloride end-use products.  Handler PPE
requirements for mepiquat chloride are to be based  solely on the  applicable acute  toxicity

                                          47

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categories of individual end-use products. EPA notes that the exposure and risk assessment for
aerial applications is based on the use of enclosed cockpits, since that is the only data available
at this time.  However, since application rates are extremely low and MOEs for aerial application
are greater than 1 X 106, EPA has  determined that imposing engineering control requirements
(enclosed cockpits) for aerial application is not warranted.  Therefore,  open cockpits will  be
acceptable for use in applying mepiquat chloride.

                    b.      Entry Restrictions

        As a result of the reregistration evaluation of the acute and other adverse effects of
mepiquat chloride, the  Agency has determined that the risks from post-application exposures to
mepiquat chloride by workers  warrant the minimum WPS REI of 12 hours. Furthermore, since
EPA has determined that the risks from adverse effects are  minimal, EPA is establishing the
minimum WPS early-entry  PPE  of coveralls, chemical-resistant gloves,  shoes  and socks.
Registrants wishing to apply for a 4-hour REI need to first satisfy the associated epidemiological
and end-use product toxicity data requirements.

                    c.      Worker Notification

        Mepiquat chloride is not classified as toxicity category I for acute dermal toxicity or skin
irritation potential and  is not  classified as a severe skin sensitizer.  Because EPA has no special
concerns about mepiquat chloride for adverse  effects where  a single exposure can trigger the
effect, EPA has not established an unusually long restricted-entry interval.  Therefore, at this
time,  EPA is not requiring a WPS  "double" notification statement on the labeling of mepiquat
chloride end-use products.

                    d.      Plant Back Interval

       Based on the results of the  rotational crop study, the registrant  must amend all of its
mepiquat chloride end-use products to establish a plant back interval of 2.5 months.

              8.     Spray Drift Advisory

       The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and
State Lead Agencies for pesticide regulation to develop the best spray drift management practices.
The Agency is now requiring interim measures that must be placed on product labels/labeling as
specified in Section V.  Once the Agency completes its evaluation of the new data base submitted
by the Spray Drift Task Force, a membership of U.S. pesticide registrants,  the Agency may
impose further refinements in  spray drift management practices to further reduce off-target drift
and risks associated with this drift.
                                           48

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V.     ACTIONS REQUIRED OF REGISTRANTS

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

       A.    Manufacturing-Use Products

             1.     Additional Generic Data Requirements

       Table II of the Pesticide Assessment Guideline (Subdivision 0), Residue Chemistry, issued
9/95)  now recognizes cotton gin byproducts  as  a raw  agricultural commodity  of cotton.
Therefore, field residue data must be submitted by the registrants by March  17, 1997 for cotton
gin byproducts and a tolerance  must be proposed for this commodity when adequate field residue
data  have been submitted and evaluated.  The  generic data base supporting the reregistration of
mepiquat chloride for the above eligible uses has been reviewed and determined to be substantially
complete. A rabbit developmental study has been required of the registrants as confirmatory data.

             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 an [fill  blank with Insecticide, Herbicide or the applicable
       term which describes the type of pesticide use(s)] for the following use(s) [fill  blank only
       with those uses that are being supported by MP registrant]."

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

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

(b)     "This  product may be used to formulate  products for  any  additional  use(s)  not
       listed on the MP label if the formulator,  user group, or grower has complied with
       U.S. EPA submission  requirements regarding support of such use(s)."
                                          49

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       B.     End-Use Products

              1.     Additional Product-Specific Data Requirements

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

              2.     Labeling Requirements for End-Use Products

       When end-use product DCIs are developed  (e.g., at issuance of the RED), the Agency will
require that all end-use product labels (e.g., MAI  labels, SLNs, and products subject  to the
generic data exemption) be amended such that they are consistent with the basic producer labels.

                    a.     PPE/Engineering Control Requirements for Pesticide Handlers

       For sole-active-ingredient end-use products that contain mepiquat chloride, the handler
personal protective equipment requirements set forth in this section must be incorporated on all
mepiquat chloride product labels. Any conflicting  PPE requirements on current labeling must be
removed.   There are currently no multiple-active-ingredient end-use products that contain
mepiquat chloride.

Actual End-use Product PPE Requirements:  PPE for handlers is  to be established based on the
acute  toxicity  of each end-use product, using the instructions in PR Notice 93-7.  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 that PR Notice.

                    b.     Entry Restrictions

       For sole-active-ingredient end-use products that contain mepiquat chloride, product labels
must  be revised to adopt the entry restrictions set forth in this section.  Any conflicting entry
restrictions on current labeling  must be removed.  There  are  currently no multiple-active-
ingredient end-use products that contain mepiquat chloride.

       The REI and early-entry PPE must be inserted into the  standardized REI and early-entry
PPE statements required by Supplement Three of PR Notice 93-7.

Restricted-entry interval: A 12-hour restricted entry interval  (REI) is required for uses within the
scope of the WPS (see  tests in PR Notices 93-7 and  93-11) on all end-use products.
                                           50

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Early-entry personal protective equipment (PPE):  The PPE required for early entry is:
       — coveralls,
       — chemical-resistant gloves, and
       — shoes plus socks.

                    c.     Other Label Requirements

       The Agency  is requiring the following labeling statements to be located on all end-use
products containing mepiquat chloride:

                           (1)     Application Restrictions

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

"Do not plant another crop within 75 days after last treatment."

                           (2)     User Safety Requirements

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

                           (3)     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."

                    d.     Spray Drift Labeling

       The following language must be placed on the label each product that can be applied
aerially:

       "Avoiding spray drift at the application site is the responsibility of the applicator. The
       interaction of many equipment-and-weather-related factors determine the potential for
       spray drift.  The applicator and the grower are responsible for considering all these factors
       when making decisions."
                                           51

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       The following drift management requirements must be followed to avoid off-target drift
movement from aerial applications to agricultural field crops.  These requirements do not apply
to forestry applications, public health uses or to applications using dry formulations.

1.     The distance of the outer most nozzles on the boom must not exceed 3/4 the length of the
wingspan or rotor.

2.     Nozzles must always point backward parallel with  the air stream and never be pointed
downwards more than 45 degrees.

       Where states have more stringent regulations, they should be observed.

       The applicator should be familiar with and take into account the information covered in
the Aerial Drift Reduction Advisory Information.

       The following aerial drift reduction advisory information must be contained in the product
labeling:

       [This section is  advisory  in nature  and does not  supersede  the  mandatory label
       requirements.]

INFORMATION ON DROPLET SIZE

       The most effective way to reduce drift potential is to apply large droplets.  The best drift
management strategy is to apply the largest droplets that provide sufficient  coverage and  control.
Applying larger droplets reduces drift potential, but will not prevent drift if applications are made
improperly,  or  under unfavorable environmental  conditions  (see Wind, Temperature and
Humidity, and Temperature Inversions).

CONTROLLING DROPLET SIZE

•     Volume - Use high flow rate nozzles to apply the highest practical spray volume.   Nozzles
       with higher rated flows produce larger droplets.

•     Pressure - Do not exceed the nozzle manufacturer's  recommended pressures. For many
       nozzle types lower pressure produces larger droplets.  When higher flow rates are  needed,
       use higher flow rate nozzles instead of increasing pressure.

•     Number of nozzles - Use the minimum number of nozzles that provide uniform coverage.

•     Nozzle Orientation -  Orienting nozzles so  that the spray is released  parallel to  the
       airstream  produces  larger  droplets  than other  orientations and  is the  recommended
       practice.  Significant deflection from horizontal will reduce droplet size  and increase drift
       potential.


                                           52

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•      Nozzle Type - Use a nozzle type that is designed for the intended application.  With most
       nozzle types,  narrower spray angles  produce larger  droplets.  Consider using low-drift
       nozzles.  Solid stream nozzles oriented straight back produce the largest droplets and the
       lowest drift.

BOOM LENGTH

       For some use patterns, reducing the effective boom length to less than 3/4 of the wingspan
or rotor length may further reduce drift without reducing swath width.

APPLICATION HEIGHT

       Applications should not be made at  a height greater than  10  feet above the top of the
largest plants unless a greater height is required for aircraft safety. Making applications at the
lowest height that is safe reduces  exposure of droplets to evaporation and wind.

SWATH ADJUSTMENT

       When applications  are made with a crosswind, the swath will be displaced downward.
Therefore, on the up and downwind edges of the field, the applicator must compensate for this
displacement by adjusting the path of the aircraft upwind.   Swath adjustment distance should
increase, with increasing drift potential  (higher wind, smaller drops, etc.)

WIND

       Drift potential is lowest between wind speeds of 2-10 mph.  However, many  factors,
including droplet  size and  equipment  type determine  drift potential  at any  given  speed.
Application should be avoided below 2 mph due to variable wind direction and high inversion
potential.  NOTE: Local terrain can influence wind patterns.  Every  applicator should be  familiar
with local wind patterns and how they affect spray drift.

TEMPERATURE AND HUMIDITY

       When making applications in low relative humidity,  set up equipment to produce larger
droplets to compensate for evaporation.  Droplet evaporation is most severe when conditions are
both hot and dry.

TEMPERATURE INVERSIONS

       Applications should not occur during a temperature inversion because drift potential is
high.  Temperature inversions restrict vertical air mixing, which causes small suspended droplets
to remain in a concentrated cloud.  This cloud can move in unpredictable directions due to the
light variable winds  common during inversions.   Temperature inversions are characterized by
increasing temperatures with altitude and are common on nights with  limited cloud cover and light


                                          53

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to no wind.  They begin to form as the sun sets and often continue into the morning.  Their
presence can be indicated by ground fog; however, if fog is not present, inversions can also be
identified by the  movement of smoke  from a ground source or an aircraft  smoke generator.
Smoke that  layers and moves laterally in a concentrated cloud (under low wind conditions)
indicates an inversion, while smoke that moves upward  and rapidly dissipates indicates good
vertical air mixing.

SENSITIVE AREAS

       The pesticide should only be applied when the potential for drift to adjacent sensitive areas
(e.g. residential areas, bodies of water, known habitat for threatened or endangered species, non-
target crops) is minimal (e.g. when wind is blowing away from the sensitive areas).

       C.     Tolerance Revocation and Import Tolerances

GENERAL PROCESS AND INSTRUCTION INFORMATION

       Several existing mepiquat chloride tolerances are being  cancelled as part  of EPA's
reregistration  eligibility decision regarding this pesticide.  The specific need for  each  of these
actions appears in the previous section.  It is EPA'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.

       In responding, EPA 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
case-by-case, depending on the number of products involved, the number of label changes,  and
other factors.  Refer to "Existing Stocks of Pesticide  Products; Statement of Policy";  Federal
Register, Volume 56, No. 123, June 26,  1991.
                                           54

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       The Agency has determined that registrants may distribute  and sell mepiquat chloride
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.
                                           55

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56

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VI. APPENDICES
      57

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58

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Report Run Date: 09/20/96   )   Time  10:49
Report Date: 09/13/95
                                            APPENDIX A REPORT
Case 2375[Mepiquat chloride]  Chemical  109101[N,N-Dimethylpiperidinium chloride]
                               LUIS  3.1 -  Page:
                                                   &13C
SITE Application Type, Application        Form(s)
  Timing, Application Equipment   )
  Surface Type  (Antimicrobial  only)  &  Effica-
  cy Influencing Factor  (Antimicrobial only)
Min. Appl.      Max. Appl.  Soil  Max.  # Apps Max.  Dose [(AI
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
 Min.  Re-        Geographic Limitations       Use
Interv Entry   Allowed           Disallowed   Limitations
(days) Intv.                                   Codes
USES ELIGIBLE FOR REREGISTRATION

FOOD/FEED USES
COTTON  (UNSPECIFIED)

Low volume spray  (concentrate),  Foliar,    DF
Aircraft
                      Use Group:  TERRESTRIAL FOOD*FEED CROP
                                           FM/L
                .04375 Ib A
                                                                   .04397 Ib A
                                             .066 Ib
                                                               14   0.5 d  AL, AR, AZ, CA,
                                                                           FL, GA, LA, MO,
                                                                           MS, NM, NC, OK,
                                                                           SC, TN, TX, VA

                                                               14   0.5 d  AL, AR, AZ, CA,
                                                                           FL, GA, LA, MO,
                                                                           MS, NM, NC, OK,
                                                                           SC, TN, TX, VA
                                              C46,  C92,  CAL,
                                              CCC(2),  GOK30),
                                              G83(30),  G88,
                                              HOK30)

                                              C46,  CAL,  CAU,
                                              CCC(2),  GOK30),
                                              G83(30),  HOK30)
                                           FM/L
                                           P/T
Spray, Foliar, Aircraft
                                           FM/L
                                                                   .04375 Ib A
                                                                   .04331 Ib A
                                                                   .02188 Ib A
                                                                   .02188 Ib A
                                                                                                 .066  Ib
                                                                                                 .066  Ib
                                                               21   0.5 d  AL, AR, AZ, CA,
                                                                           FL, GA, LA, MO,
                                                                           MS, NM, NC, OK,
                                                                           SC, TN, TX, VA

                                                               21   0.5 d  AL, AR, AZ, CA,
                                                                           FL, GA, LA, MO,
                                                                           MS, NM, NC, OK,
                                                                           SC, TN, TX, VA

                                                               7    0.5 d  AL, AR, AZ, CA,
                                                                           FL, GA, LA, MO,
                                                                           MS, NM, NC, OK,
                                                                           SC, TN, TX, VA

                                                               7    0.5 d  AL, AR, AZ, CA,
                                                                           FL, GA, LA, MO,
                                                                           MS, NC, NM, OK,
                                                                           SC, TN, TX, VA
                                                                                                                                                              C46,  CAL,  CAU,
                                                                                                                                                              CCC(2),  GOK30),
                                                                                                                                                              G83(30),  HOK30)
                                                                                                                                                              C46,  CAG,  CAL,  CAU,
                                                                                                                                                              CCC(2),  GOK30),
                                                                                                                                                              G83(30),  HOK30)
                                              C46,  C92,  CAL,
                                              CCC(4),  GOK30),
                                              G83(30),  G88,
                                              HOK30)

                                              C46,  CAL,  CAU,
                                              CCC(4),  GOK30),
                                              G83(30),  HOK30)
                                           FM/L
                                                                   .02198 Ib A
                                                                                                 .066  Ib
                                                                                                                        0.5 d  AL, AR, AZ, CA,
                                                                                                                               FL, GA, LA, MO,
                                                                                                                               MS, NM, NC, OK,
                                                                                                                               SC, TN, TX, VA
                                                                                                           C46,  CAL,  CAU,
                                                                                                           CCC(4),  GOK30),
                                                                                                           G83(30), HOK30)
                                                                                             59

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Report Run Date: 09/20/96
PRD Report Date: 09/13/95
)  Time 10:49
                                                       LUIS 3.1 - Page:
                                            APPENDIX A REPORT
Case 2375[Mepiquat chloride]  Chemical  109101[N,N-Dimethylpiperidinium chloride]
»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»4AAAAAA£»»»»»»»»»»»»»»»»»»»»»»»»»».
                                           Form(s)
SITE Application Type, Application        Form(s)   Min.  Appl.
  Timing, Application Equipment   )                 Rate (AI un-
  Surface Type  (Antimicrobial  only)  &  Effica-      less noted
  cy Influencing Factor  (Antimicrobial only)        otherwise)
  Max. Appl. Soil Max. # Apps Max.  Dose [ (AI   Min.   Re-
    Rate  (AI Tex. @ Max. Rate unless  noted    Interv Entry
unless noted Max. /crop /year otherwise) /A]    (days)  Intv.
  otherwise) Dose cycle       /crop    /year
                              cycle
                                                                                                        Geographic Limitations
                                                                                                    Allowed           Disallowed
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATIOH

FOOD/FEED USES  (con't)
COTTON  (UNSPECIFIED)  (con't)
                                                                          Use Group: TERRESTRIAL  FOOD+FEED CROP (con't)
                                           P/T
Spray, Foliar, Ground
                                           FM/L
                                                                   .02166 Ib A
                                                                   .02188 Ib A
                                                                   .02188 Ib A
                                                                                                 .066  Ib
                                                                                             0.5 d  AL,  AR,  AZ,  CA,
                                                                                                   FL,  GA,  LA,  MO,
                                                                                                   MS,  NC,  NM,  OK,
                                                                                                   SC,  TN,  TX,  VA

                                                                                             0.5 d  AL,  AR,  AZ,  CA,
                                                                                                   FL,  GA,  LA,  MO,
                                                                                                   MS,  NM,  NC,  OK,
                                                                                                   SC,  TN,  TX,  VA

                                                                                             0.5 d  AL,  AR,  AZ,  CA,
                                                                                                   FL,  GA,  LA,  MO,
                                                                                                   MS,  NC,  NM,  OK,
                                                                                                   SC,  TN,  TX,  VA
                                                                                                                                                               C46,  CAG,  CAL,  CAU,
                                                                                                                                                               CCC(4),  GOK30),
                                                                                                                                                               G83(30),  HOK30)
                                                                                            C46,  C92,  CAL,
                                                                                            CCC(4),  GOK30),
                                                                                            G83(30),  G88,
                                                                                            HOK30)

                                                                                            ,  C46, CAL,  CAU,
                                                                                            CCC(4),  GOK30),
                                                                                            G83(30),  HOK30)
                                           FM/L
                                           FM/L
                                                                   .02188 Ib A
                                                                   .02198 Ib A
                                                                                                 .066  Ib
                                                                                             0.5 d  AL,  AR,  AZ,  CA,
                                                                                                   FL,  GA,  LA,  MO,
                                                                                                   MS,  NC,  NM,  OK,
                                                                                                   SC,  TN,  TX,  VA

                                                                                             0.5 d  AL,  AR,  AZ,  CA,
                                                                                                   FL,  GA,  LA,  MO,
                                                                                                   MS,  NM,  NC,  OK,
                                                                                                   SC,  TN,  TX,  VA
                                                                                                                                                               C46,  CAL,  CAU,
                                                                                                                                                               CCC(4),  GOK30),
                                                                                                                                                               G83(30),  HOK30)
                                                                                                                                                               C46,  CAL,  CAU,
                                                                                                                                                               CCC(4),  GOK30),
                                                                                                                                                               G83(30),  HOK30)
                                           P/T
Spray, Foliar, Sprayer
                                                                   .02166 Ib A
                                                                   .04375 Ib A
                                                                                                 .065  Ib
                                                                                             0.5 d  AL,  AR,  AZ,  CA,
                                                                                                   FL,  GA,  LA,  MO,
                                                                                                   MS,  NC,  NM,  OK,
                                                                                                   SC,  TN,  TX,  VA

                                                                                             0.5 d  AL,  AR,  AZ,  CA,
                                                                                                   FL,  GA,  LA,  MO,
                                                                                                   MS,  NM,  NC,  OK,
                                                                                                   SC,  TN,  TX,  VA
                                                                                                                                                               C46,  CAG,  CAL,  CAU,
                                                                                                                                                               CCC(4),  GOK30),
                                                                                                                                                               G83(30),  HOK30)
                                                                                                                                                               C46,  C92,  CAL,
                                                                                                                                                               CCC(2),  GOK30),
                                                                                                                                                               G83(30),  G88,
                                                                                                                                                               HOK30)
                                                                                             60

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Report Run Date: 09/20/96
PRD Report Date: 09/13/95
)  Time 10:49
                                                       LUIS 3.1 - Page:
                                            APPENDIX A REPORT
Case 2375[Mepiquat chloride]  Chemical  109101[N,N-Dimethylpiperidinium chloride]
»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»4AAAAAA£»»»»»»»»»»»»»»»»»»»»»»»»»».
                                           Form(s)
SITE Application Type, Application        Form(s)   Min.  Appl.
  Timing, Application Equipment   )                 Rate (AI un-
  Surface Type  (Antimicrobial  only)  &  Effica-       less noted
  cy Influencing Factor  (Antimicrobial only)        otherwise)
  Max. Appl. Soil Max. # Apps Max.  Dose  [ (AI   Min.   Re-
    Rate  (AI Tex. @ Max. Rate unless  noted    Interv Entry
unless noted Max. /crop /year otherwise) /A]    (days)  Intv.
  otherwise) Dose cycle       /crop   /year
                              cycle
                                                                                                        Geographic Limitations
                                                                                                    Allowed           Disallowed
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATIOH

FOOD/FEED USES  (con't)
COTTON  (UNSPECIFIED)  (con't)
                                                                          Use Group: TERRESTRIAL  FOOD+FEED CROP (con't)
                                           FM/L     NA
                                                                   .04397 Ib A
                                                                                  NS   14   0.5 d  AL, AR,  AZ,  CA,
                                                                                                   FL, GA,  LA,  MO,
                                                                                                   MS, NM,  NC,  OK,
                                                                                                   SC, TN,  TX,  VA
                                                                                                                                                              C46,  CAL,  CAU,
                                                                                                                                                              CCC(2),  GOK30),
                                                                                                                                                              G83(30),  HOK30)
                                           FM/L     NA
                                           P/T      NA
                                                                   .04375 Ib A
                                                                   .04331 Ib A
                                                                     .066 Ib      NS   21   0.5 d  AL, AR,  AZ,  CA,
                                                                                                   FL, GA,  LA,  MO,
                                                                                                   MS, NM,  NC,  OK,
                                                                                                   SC, TN,  TX,  VA

                                                                     .065 Ib      NS   21   0.5 d  AL, AR,  AZ,  CA,
                                                                                                   FL, GA,  LA,  MO,
                                                                                                   MS, NM,  NC,  OK,
                                                                                                   SC, TN,  TX,  VA
                                                                                                                                                              C46,  CAL,  CAU,
                                                                                                                                                              CCC(2),  GOK30),
                                                                                                                                                              G83(30),  HOK30)
                                                                                                                                                              C46,  CAG,  CAL,  CAU,
                                                                                                                                                              GOK30),  G83(30),
                                                                                                                                                              HOK30)
Spray, Foliar, Ultra low volume
                                           FM/L     NA
                                                                   .02188 Ib A
                                                                                                 .066  Ib
                                                                                                                        0.5 d  AL, AR, FL, GA,
                                                                                                                               LA, MO, MS, NC,
                                                                                                                               OK, SC, TN, TX
                                                                                                                                   C46, CAL, CAU,
                                                                                                                                   CCC(4), GOK30),
                                                                                                                                   G83(30), G88,
                                                                                                                                   HOK30)
                                           FM/L     NA
                                           P/T      NA
                                                                   .02198 Ib A   *   3    NS     .066  Ib
                                                                   .02166 Ib A   *   3    NS     .065  Ib
                                                                                            0.5 d  AL, AR,  FL,  GA,
                                                                                                   LA, MO,  MS,  NC,
                                                                                                   OK, SC,  TN,  TX

                                                                                            0.5 d  AL, AR,  FL,  GA,
                                                                                                   LA, MO,  MS,  NC,
                                                                                                   OK, SC,  TN,  TX
                                                                                                                                                              C46,  CAL,  CAU,
                                                                                                                                                              CCC(4),  G88,  HOK30)
                                                                                                                                                              C46,  CAG,  CAL,  CAU,
                                                                                                                                                              CCC(4),  GOK30),
                                                                                                                                                              G83(30),  G88,
                                                                                                                                                              HOK30)
Ultra low volume, Foliar, Aircraft         FM/L     NA
                                                                   .04397 Ib A   *   1    NS     .066  Ib
                                                                                                                   14   0.5 d  AL, AR, FL, GA,
                                                                                                                               LA, MO, MS, NC,
                                                                                                                               OK, SC, TN, TX
                                                                                                                                   C46, CAL, CAU,
                                                                                                                                   CCC(2), G88, HOK30)
                                           FM/L     NA
                                                                   .04375 Ib A   *   1    NS     .066  Ib
                                                                                                                   21   0.5 d  AL, AR, FL, GA,
                                                                                                                               LA, MO, MS, NC,
                                                                                                                               OK, SC, TN, TX
                                                                                                                                   C46, CAL, CAU,
                                                                                                                                   CCC(2), GOK30),
                                                                                                                                   G83(30), G88,
                                                                                                                                   HOK30)
                                                                                             61

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Report Run Date: 09/20/96
PRD Report Date: 09/13/95
)  Time 10:49
                                                      LUIS 3.1  - Page:
                                           APPENDIX A REPORT
Case 2375[Mepiquat chloride] Chemical 109101[N,N-Dimethylpiperidinium chloride]
»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»»4AAAAAA£»»»»»»»»»»»»»»»»»»»»»»»»»».
                                          Form(s)
SITE Application Type, Application        Form(s)  Min. Appl.
  Timing, Application Equipment  )                 Rate  (AI un-
  Surface Type  (Antimicrobial only) & Effica-      less noted
  cy Influencing Factor  (Antimicrobial only)       otherwise)
  Max. Appl. Soil Max. # Apps Max. Dose  [ (AI   Min.  Re-
    Rate  (AI Tex. @ Max. Rate unless noted    Interv Entry
unless noted Max. /crop /year otherwise) /A]    (days) Intv.
  otherwise) Dose cycle       /crop    /year
                              cycle
                                                                                                       Geographic Limitations
                                                                                                    Allowed           Disallowed
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATIOH

FOOD/FEED USES  (con't)
COTTON (UNSPECIFIED)  (con't)
                                                                         Use  Group:  TERRESTRIAL FOOD+FEED CROP (con't)
                                          P/T      NA
                                                                   .04331  Ib A
                                                                                                             NS   21   0.5 d  AL, AR, FL, GA,
                                                                                                                              LA, MO, MS, NC,
                                                                                                                              OK, SC, TN, TX
                                                                                                                                  C46,  CAG,  CAL,  CAU,
                                                                                                                                  CCC(2),  GOK30),
                                                                                                                                  G83(30), G88,
                                                                                                                                  HOK30)
                                                                                            62

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Report Run Date: 09/20/96  )  Time 10:49
PRD Report Date: 09/13/95
                                           APPENDIX A REPORT

Case 2375[Mepiquat chloride] Chemical 109101[N,N-Dimethylpiperidinium chloride]
                                                                               LUIS 3.1 - Page:    5
LEGEND
444444
  Sort: Uses Eligible or Ineligible for Re-registration, Food/Feed or Non-Food/Non-Feed Uses, Alpha Site Name, Use Group Name, Alpha Application Type/Timing/Equipment
        Description, Formulation, Maximum Application Rate Unit/Area Quantity, Minimum Application Rate

  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)
                             :  Maximum dose for a single application to a single site as related to soil texture  (Herbicide claims only).
                             :  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"
                             :  Maximum dose applied to a site over a single crop cycle or year.  System calculated.
Soil Tex. Max. Dose
Max. # Apps @ Max. Rate
Max. Dose [(AI unless
noted otherwise)/A]
Min. Interv (days)
Re-Entry Intv.
PRD Report Date
                             :  Minimum Interval between Applications  (days)
                             :  Reentry Intervals
                             :  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
  C       :  Coarse
  M       :  Medium
  F       :  Fine
  O       :  Others

  FORMULATION CODES
  DF      :  WATER DISPERSIBLE GRANULES (DRY FLOWABLE)
  FM/L    :  FORM NOT IDENTIFIED/LIQUID
  P/T     :  PELLETED/TABLETED

  ABBREVIATIONS
  AN      :  As Needed
  NA      :  Not Applicable
  NS      :  Not Specified (on label)
  UC      :  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
  DCNC    :  Dosage Can Not be Calculated
  No Calc :  No Calculation can be made
  W       :  PPM calculated by weight
  V       :  PPM Calculated by volume
  U       :  Unknown whether PPM is given by weight or by volume
  cwt     :  Hundred Weight
  nnE-xx  :  nn times (10 power -xx) ; for instance,  "1.234E-04" is equivalent to
                                                                                  .0001234"
                                                                                           63

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Report Run Date: 09/20/96
PRD Report Date: 09/13/95
                         )  Time 10:49
                                                                               LUIS 3.1 - Page:
                                           APPENDIX A REPORT
Case 2375[Mepiquat chloride] Chemical 109101[N,N-Dimethylpiperidinium chloride]
  USE LIMITATIONS CODES
  C46 :  Do not apply through any type of irrigation system.
        For terrestrial uses, do not apply directly to water or to areas where surface water is present or to intertidal areas below the mean high water mark.
        Do not apply where runoff is likely to occur.
        Do not contaminate water, food or feed.
        Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
        Do not make more than 	 applications per crop cycle.
C92
CAG
CAL
CAU
CCC
GDI
G83
G88
HOI
        	 day(s) pregrazing interval.
        	 day(s) prefeeding interval.
        Do not graze or feed forage.
        	 day(s) preharvest interval.
  * NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
  GEOGRAPHIC CODES
  AL
  AR
  AZ
  CA
  FL
  GA
  LA
  MO
  MS
  NC
  NM
  OK
  SC
  TN
  TX
  VA
      Alabama
      Arkansas
      Arizona
      California
      Florida
      Georgia
      Louisiana
      Missouri
      Mississippi
      North Carolina
      New Mexico
      Oklahoma
      South Carolina
      Tennessee
      Texas
      Virginia
  REENTRY INTERVAL ABBREVIATIONS
  d      :  day(s)
                                                                                           64

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                                         GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active ingredients within the case
mepiquat chloride covered by this Reregistration Eligibility Decision Document. It contains generic data requirements
that apply to mepiquat chloride in all products, including data requirements  for which a "typical formulation" is the test
substance.

       The data table is organized in the following format:

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

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

                           A      Terrestrial food
                           B      Terrestrial feed
                           C      Terrestrial non-food
                           D      Aquatic food
                           E      Aquatic non-food outdoor
                           F      Aquatic non-food industrial
                           G      Aquatic non-food residential
                           H      Greenhouse food
                           I       Greenhouse non-food
                           J      Forestry
                           K      Residential
                           L      Indoor food
                           M     Indoor non-food
                           N      Indoor medical
                           0      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.
                                                     65

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                              APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Mepiquat Chloride
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-7
63-8
63-9
63-11
63-12
63-13
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Density
Solubility
Vapor Pressure
Octanol/Water Partition
PH
Stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
41889001
41889001
41889001
41889002, 42690701
41889003, 42690701
41889002
41626701
41626701
41626701
41626701
41626701
41889004, 42690702
41626701
41910101
41626701
41626701
ECOLOGICAL EFFECTS
71-1A
71-2A

Acute Avian Oral - Quail/Duck
Avian Dietary - Quail

ALL
ALL
67
43150701, 135130
135131


-------
Data Supporting Guideline Requirements for the Reregistration of Mepiquat Chloride
REQUIREMENT
71-2B
71-4
72-1A
72-1C
72-2A
72-3A
72-3B
72-3C
72-4A
72-4B
122-1A
122-1B
122-2
141-1
Avian Dietary - Duck
Avian Reproduction
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity - Mollusk
Estuarine/Marine Toxicity - Shrimp
Early Life Stage - Fish
Life Cycle - Invertebrate
Seed Germination/Seedling Emergence
Vegetative Vigor
Aquatic Plant Growth
Honey Bee Acute Contact
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
135132
Waived
41889005, 135133
41889006, 135133
43471001, 135134
43516701
43516702
43516703
43155901
43155902
41488109
41889008
41488110
41626703
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
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
ALL
ALL
ALL
ALL
ALL
ALL
41488101
41488102
41954101
00071942, 92091006
41488103, 92091007
41488104, 92091008
                                               68

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      Data Supporting Guideline Requirements for the Reregistration of Mepiquat Chloride
REQUIREMENT
                                         USE PATTERN
                            CITATION(S)
81-7
82-1A
82-1B
83-1A
83-1B
83-2A
83-2B
83-3A
83-3B
83-4
84-2A
84-2B
84-4
85-1
Acute Delayed Neurotoxicity - Hen
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
General Metabolism
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
42337104
42337102, 42337103
135720
43264402
41488105, 43264403
43396001
43264404
42337101
148089, 148090, 92091010,
44102201
43378601
41488106
41488107
41488108
40299001
ENVIRONMENTAL FATE
160-5
161-1
161-2
161-3
Chemical Identity
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
ALL
ALL
ALL
ALL
41889001
41488111
41488112
127749, 41889009, 42412103,
162-1
Aerobic Soil Metabolism
ALL
43455801
43455801, 42412103
                                                       69

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       Data Supporting Guideline Requirements for the Reregistration of Mepiquat Chloride
REQUIREMENT
USE PATTERN
              CITATION(S)
162-2       Anaerobic Soil Metabolism
163-1       Leaching/Adsorption/Desorption
164-1       Terrestrial Field Dissipation
165-1       Confined Rotational Crop
165-4       Bioaccumulation in Fish
201-1       Droplet Size Spectrum
202-1       Drift Field Evaluation
RESIDUE CHEMISTRY
171-4A     Nature of Residue - Plants
171-4B     Nature of Residue - Livestock
    ALL
    ALL
    ALL
    ALL
    ALL
    ALL
    ALL

    ALL
    ALL
41889010, 43455801
41488113
42353301, 43415401
42733601
136360
Spray Drift Task Force studies
Spray Drift Task Force studies

43024701, 42330804
42394301/2/3,
43290401/2/3/4/5
171-4C

171-4D
171-4E
171-4J
171-4K
171-4L
Residue Analytical Method - Plants

Residue Analytical Method - Animal
Storage Stability
Magnitude of Residues -
Meat/Milk/Poultry/Egg
Crop Field Trials
Processed Food
ALL

ALL
ALL
ALL
ALL
ALL
42426801, 42734601/2,
42734601/2, 42892201,
43378501, 43738603
42394303, 42546201/2
42734601/2, 42892201,
43738603, 43379501
43738601/2
42734601/2
42426803
                                                           70

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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.

       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."


                                                     71

-------
(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.
                                      72

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          MRID
                                         BIBLIOGRAPHY
CITATION
00071942     Leuschner, F. (1977) Tolerance of the Rabbit Ocular Mucosa to 1,1-Dimethylpiperidinium Chloride,
             Reg. No. 85559, Techn.-Called for Short DMP: Single Treatment.  (Unpublished study received Nov
             15, 1977 under 8G2022; prepared by Laboratorium fur Pharmakologie und Toxikologie, West Germany,
             by BASF Wyandotte Corp., Parsippany,  N.J.; CDL:096634-L)

00127749     Otto, S. (1978) Investigations into the Aerobic Degradation of 14C-dimethylpiperidinium Chloride in
             Soil: Report No. 1505.  (Unpublished study received Feb 22, 1978 under 7969-EX-9; prepared by BASF,
             AG, W. Ger., submitted by BASF Wyandotte Chemical Corp., Parsippany, NJ; CDL:097065-A)

00135131     Fink, R.; Beavers, J.; Brown, R. (1977) Eight-day Dietary LC50-Bobwhite Quail: BAS 083 00 W:
             Project  No. 147-109: Final rept. (Unpublished study received Nov 15, 1977 under 8G2022; submitted
             by BASF Wyandotte Chemical Corp., Parsippany, NJ; CDL: 096636-B)

00135132     Fink, R.; Beavers, J.; Brown, R. (1977) Eight-day Dietary LC50-Mallard Duck: BAS 083 00 W: Project
             No. 147-110:  Final rept (Unpublished study received Nov 15, 1977 under 8G2022; submitted by BASF
             Wyandotte Chemical Corp., Parsippany,  NJ;  CDL: 096636-C)

00135133     Kuc,  W. (1977) Acute Toxicity of BAS  083  OOW to the Bluegill Sunfish and Rainbow Trout: UCES
             Project #11506-17-04; BWC Project IV-l-G-124.  (Unpub. study received Nov 15, 1977 under 8G2022;
             prepared  by  Union  Carbide  Corp.,   by  BASF  Wyandotte  Chemical Corp.,  Parsippany,  NJ;
             CDL:096636-D)

00135134     Vilkas, A. (1977) The Acute Toxicity of BAS 08300 W to the Water Flea ...: UCES Proj. #11506-17-04;
             BWC Project  IV-3-G-124. (Unpublished study received Nov 15, 1977 under 8G2022; prepared by Union
             Carbide Corp., submitted by BASF Wyandotte Chemical Corp., Parsippany, NJ; CDL:096636-E)

00135720     Leuschner,   F.;   Leuschner,  A.;   Schwerdtfeger,   W.;  et al.  (1977)   Oral  Toxicity   of
             1,1-Dimethylpiperidinium Chloride, Reg. No. 85559, Techn.—Called for Short DMP—in the Beagle Dog:
             Repeated Dosage over 3 Months.  (Unpublished study received Nov 15, 1977 under 8G2022; prepared
             by Laboratorium fur Pharmakologie und Toxikologie, W. Ger., submitted by BASF Wyandotte Chemical
             Corp., Parsippany, NJ; CDL:096640-B)

00136360     Kuc, W. (1978) 14C-BAS  083 00 W: Bluegill Sunfish, Lepomis  macrochirus Bioconcentration Study:
             UCES Proj. No. 11506-34;  BWC Proj. No. IV-l-G-132.  Final rept.  (Unpublished study received Mar
             30, 1979 under 7969-52; prepared by Union Carbide Corp., submitted by BASF Wyandotte Chemical
             Corp., Parsippany, NJ; CDL:098034-B)

00148089     Hildebrand,   B.;   Merkle,   J.   (1981)   Study   To  Determine  the   Prenatal  Toxicity   of
             1,1-Dimethyl-piperidinium Chloride in Rabbits.  Unpublished study prepared by BASF Wyandotte Corp.
             60 p.

00148090     Hofmann, T.; Merkle,  J. (1979) Study of the  Prenatal Toxicity of 1,1-Dimethyl-piperidinium-chloride
             on Rabbits.  Unpublished study prepared by BASF Wyandotte Corp.  106 p.
                                                  73

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40299001     Holloway, C.  (1987) Study Report on the Biokinetics and Metabolic Fate of 1,1-Dimethylpiperidinium
             chloride in Young Adult Rats: Proj. No. NA 869748. Unpublished study prepared by NATEC Inst. fur
             Naturwissenschafflich-tenische Dienste GMbH. 329 p.

41488101     Kirsch, ?. (1989) Report on the Study of the Acute Oral Toxicity of Mepiquat Chloride in Rats: Lab
             Project Number: 89/0462. Unpublished study prepared by BASF Aktiengesellschaft. 15 p.

41488102     Kirsch, ?. (1989) Report on the Study of the Acute Dermal Toxicity of Mepiquat Chloride in Rats: Lab
             Project Number: 89/0461. Unpublished study prepared by BASF Aktiengesellschaft. 15 p.

41488103     Grundler, 0. (1989) Report on the Study  of the Sensitizing Effect of Mepiquat Chloride (...) in the
             Guinea Pig According to Proposed Rules"  of EPA, Aug 22,  1078, Federal Register: Lab Project No:
             85/0080.  Unpublished study  prepared by BASF Aktiengesellschaft. 18 p.

41488104     Leuschner, ?.  (1976) Tolerance of the Rabbit Skin to 1,1-Dimethylpiperidinium Chloride  (Patch Test):
             Lab  Project  Number: 76/0011. Unpublished study  prepared by  Laboratory for  Pharmacology &
             Toxicology, lip.

41488105     Hellwig,  ?.  (1989) Report on  the  Study of the Toxicity of Reg.  No. 85 559 in Beagle Dogs
             Administration via the Diet Over  12 Months : Lab Project Number: 89/0357.   Unpublished study
             prepared  by BASF Aktiengesellschaft, Dept. of Toxicology.  850 p.

41488106     Zeller, H. (1979) Report on the Testing of Reg. No. 85559 (Mepiquat Chloride) in the Ames Test: Lab
             Project Number: 79/0035. Unpublished study prepared by BASF Aktiengesellschaft. 18 p.

41488107     Taalman, R.  (1987) Clastogenic Evaluation of Mepiquat Chloride in  an  in vitro Cytogenetic Assay
             Measuring Chromosomes Aberration Frequencies in Chinese Hampster Ovary (CHO) Cells: Lab Project
             No: 87-0450.  Unpublished study prepared by Hazleton Biotechnologies.  28 p.

41488108     Cifone, M.  (1987) Report on the Mutagenicity Test on Mepiquat Chloride in the Rat Primary Hepatocyte
             Unscheduled  DNA Synthesis Assay: Lab Project Number:  87/0393. Unpublished study prepared by
             Hazleton  Laboratories America, Inc. 33 p.

41488109     Chetram,  R. (1989) Tier 1  Seed Germination/Seedling Emergence Nontarget Phytotoxicity of BAS  083
             W: Lab Project Number: 89/5092. Unpublished study prepared by Pan-Agricultural Laboratories, Inc.
             147 p.

41488110     Hughes, J. (1989) The Toxicity of Mepiquat Chloride to the Growth and Reproduction of Aquatic Plants:
             Lab Project Number: 89/5159. Unpublished study prepared by  Malcolm Pirnie, Inc. 103 p.

41488111     Funk, H.  (1989) Hydrolysis of Mepiquat Chloride in pH 3, 5, 7, and 9 Aqueous Solutions at 25 Degrees
             C: Lab Project No. 89/0313. Unpublished study prepared by BASF Aktiengesellschaft, Metabolism Lab.
             46 p.
                                                   74

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41488112     Funk, H. (1990) Unsensitized and Sensitized Photolysis of Mepiquat Chloride in Water at pH 7: Lab
             Project Number: 90/0071. Unpublished study prepared by BASF Aktiengesellschaft.  57 p.

41488113     Ellenson, J.  (1987) Soil Adsorption/Desorption of Mepiquat Chloride : Lab Project Number: 87/5076.
             Unpublished study prepared by BASF Corp.  30 p.

41585201     Kohl, W. (1989) The Metabolism of [Carbon 14]-Mepiquat Chloride in Laying Hens: BASF Registration
             Document No.: 89/0312. Unpublished prepared by BASF AG, Agricultural Research and Development.
             112 p.

41585202     Giese,  U.   (1989) Dosing of Hens with  [Carbon 14]-Mepiquat Chloride for Further Isolation and
             Identification of Metabolites: BASF Registration Document No.: 88/0604.  Unpublished study prepared
             by NATEC  Institute for Scientific and Technical Services.  27 p.

41585203     Cheng,  T. (1988) Biokineticss and Metabolism Study of [Carbon  14]BAS 083 W in Laying Hens: BASF
             Registration  Document No.: 89/5021. Unpublished study prepared by Hazleton Laboratories America.
             73 p.

41585204     Kohl, W.   (1989) The Metabolism  of  [Carbon 14]-Mepiquat Chloride  in Lactating Goats: BASF
             Registration  Document No.: 89/0424. Unpublished study prepared by BASF AG, Agricultural Research
             and Development. 95 p.

41585205     Giese, U. (1988)  Dosing of Lactating Goat with [Carbon 14]-Mepiquat Chloride for Further Isolation
             and Identification of Metabolites: BASF  Registration Document No.: 88/0616.  Unpublished study
             prepared by NATEC Institute for Scientific and Technical Services.  31 p.

41585206     Cheng, T.  (1988) Biokinetics and Metabolism Study of [Carbon 14]BAS 083 W in Lactating Goats:
             BASF Registration Document No.: 89/5022. Unpublished study prepared by Hazleton Laboratories
             America.  69 p.

41626701     Panek,  E. (1990) Determination of the Color, Physical State, Odor, Melting Point, Bulk Density, and
             PH of Mepiquat Chloride TGAI: Lab Project Number: F9018.   Unpublished study prepared by BASF
             Corp.  lip.

41626703     Hoxter, K.;  Smith, G. (1990) Mepiquat Chloride: An Acute Contact Toxicity Study with the Honey Bee:
             Lab Project Number: E9006. Unpublished study prepared by Wildlife International Ltd.  14 p.

41889001     Panek, E. (1991) Mepiquat Chloride: Product Identity and Composition: Lab Project Number: 91/5077.
             Unpublished study prepared by BASF.  87 p.

41889002     Panek,  E. (1991)  Mepiquat Chloride: 5-Batch Analysis and Method Validations: Lab Project Number:
             91/5075.  Unpublished study prepared by BASF. 87 p.
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41889003     Panek, E.  (1991)  Mepiquat  Chloride: Certification  of  Limits:  Lab Project  Number:  91/5076.
             Unpublished study prepared by BASF. lip.

41889004     Woodson, E. (1991) Determination of the Solubility of Mepiquat Choride in Selected Solvents: Lab
             Project Number: 91/5085. Unpublished study prepared by EPL Bio-Analytical Services, Inc. 41  p.

41889005     Munk, R. (1991) Report on the Study of the Acute Toxicity of Mepiquat Chloride on the Bluegill: Lab
             Project Number: 91-10227. Unpublished study prepared by BASF Aktiengesellschaft.  28 p.

41889006     Munk, R. (1991) Report on the Study of the Acute Toxicity of Mepiquat Chloride on the Rainbow Trout:
             Lab Project Number: 91-10228. Unpublished study prepared by BASF Aktiengesellschaft.  28 p.

41889008     DeMonch, P. (1991) Tier 1 Vegetative Vigor Nontarget Phytotoxicity Study Using Mepiquat Chloride:
             Lab Project Number: 91/5033. Unpublished study prepared by Pan-Agricultural Laboratories, Inc . 90
             P-

41889009     Wood, N. (1991)  Photolysis of Mepiquat Chloride on Soil: Lab Project Number: M9001: M9117:
             91/5079.  Unpublished study prepared by BASF Corp.  23 p.

41889010     Huber, R. (1991)  Investigations into the Anaerobic Degradation of Mepiquat Chloride in  Soil: Lab
             Project Number: 91-10108. Unpublished study prepared by Basf Aktiengesellschaft.  65 p.

41910101     Schweitzer, M. (1991) Determination of the n-Octanol/Water Partition Coefficient of Mepiquat Chloride:
             Lab Project Number: 91/ 5084. Unpublished study prepared  by Battelle.  40 p.

41954101     Gamer, A. (1991) The Acute Inhalation Toxicity LC50 of Mepiquat Chloride as a Liquid Aerosol in
             Rats:  4  Hour  Exposure:  Lab  Project Number:  91/10505.  Unpublished study  prepared  by BASF
             Aktiengesellschaft.  29  p.

42330804     Goetz, A. (1992) Metabolism of [carbon 14]-BAS 083 W in Cotton (Gossypium hirsutum): Lab Project
             Number:  M9016.  Unpublished study prepared by BASF Corp. 90 p.

42337101     Hellwig, J. (1992) Study of the Prenatal Toxicity of Mepiquat Chloride in Rats after Oral Administration
             (Gavage): Lab Project Number: 92/10331.  Unpublished study prepared by BASF Aktiengesellschaft.
             358 p.

42337102     Schilling, K. (1992) Supplementary Study on the Oral Toxicity of Mepiquat Chloride  in Wistar Rats
             Administration in the Diet over 3 Months: Lab Project Number: 92-10434.  Unpub. study prepared by
             BASF Aktiengesellchaft.  286 p.

42337103     Schilling,  K.  (1992) Study on the Oral Toxicity of Mepiquat Chloride in Wistar Rats Administration in
             the  Diet  Over 3 Months: Lab Project Number: 92-10433.   Unpublished study prepared  by BASF
             Aktiengesellschaft.  378 p.
                                                  76

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42337104     Franke,  C.  (1991) Report on the in  vitro Test of the Action  of Mepiquat  Chloride at Nicontinic
             Acetylcholine Receptors of Adult Mouse Muscle: Supplemental: Lab Project Number: 91/11204.
             Unpublished study prepared by Instit. of Physiology of the Techn. Univ. Munchen.  23 p.

42353301     Eubanks, M. (1992) Fix Plant Regulator (BAS 083 05 W)  Soil Dissipation in a Cotton Use Pattern Study:
             Lab Project Number: BASF 92/5083: ER92027.  Unpublished study prepared by Pan-Ag Labs, Inc.,
             Biospherics, Inc. and Harris Environmental Tech. 360 p.

42394301     Kohl,  W.  (1991) The  Metabolism  of  [carbon  14]-Mepiquat  Chloride  in  Lactating  Goats-The
             Identification of a New Metabolite in Liver and Milk: Lab Project Number: 90/10385.  Unpublished
             study prepared by BASF AG.  77 p.

42394302     Schepers, U. (1990)  Method for Determination of Mepiquat Chloride Residues in Chicken and Cow
             Matrices Based on Ion Chromotography: Lab Project Number: 90/0147. Unpublished study prepared
             by BASF AG.  50 p.

42394303     Schepers, U. (1991) Mepiquat Chloride-Accountability  of Method No. 286 in Goat Tissues and Milk:
             Lab Project Number: 91/11194.  Unpublished study prepared by BASF AG. 74 p.

42394304     McAleese, D.; Schepers,  U. (1990) Mepiquat Chloride-Accountability of Method No.  286 in Chicken
             Tissues and Eggs: Lab Project Number: 90/0138.  Unpublished study prepared by BASF AG.  70  p.

42412103     Huber, R. (1991) Further Investigations into the Aerobic Degradation of Mepiquat Chloride  in Soil:  Lab
             Project Number: 91/10952: P87-M009: 2890. Unpublished study prepared by BASF AG.  92 p.


42426801     Burkey, J.  (1992) Method for Determination of Mepiquat Chloride Residues in Cottonseed by  Ion
             Chromatography: Lab Project Number: A9106: 92/5064. Unpublished study prepared by BASF Corp.
             43 p.

42426803     Burkey, J. (1992) Magnitude of the Residues of Mepiquat  Chloride in Processing Fractions of Cottonseed
             Following Treatment with Fix Plant  Growth Regulator: Lab  Project Number: A9139:  92/5110.
             Unpublished study prepared by BASF Corp. 150 p.

42546201     Burkey, J.; Malinsky, D. (1992)  Method for Determination of Mepiquat Chloride Residues in Chicken
             and Cow Matrices Based on Ion Chromatography: Lab Project Number: A9104: 92/5130.  Unpub. study
             prepared by BASF Corp. 59 p.

42546202     Gilles, C. (1992) Independent Laboratory Validation of  Methodology to Determine Mepiquat Chloride
             in Animal  Matrices:  Lab Project Number: B9109-N1.   Unpublished study prepared  by Biospherics
             Incorporated.  67 p.

42690701     Panek, E. (1992) Mepiquat Chloride: Certification of Limits: Lab Project Number: FR9250: 92/5208:
             D12:FR9250.RPT. Unpublished study prepared by BASF.  7 p.
                                                  77

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42690702     Pawliczek, ?. (1987) Mepiquat Chloride Water Solubility: Method and Raw Data for MRID 41491001:
             Lab Project Number: 93/5020.  Unpublished study prepared by BASF AG. 22 p.

42733601     Ellenson, J.; Seachrist, L. (1993) Mepiquat Chloride:  (carbon 14)-BAS 083 W in Rotational Crops: Lab
             Project Number: M9015: M9212: 93/5035.   Unpublished study prepared by BASF Corporation and
             Pan-Agricultural Labs, Inc.   187 p.

42734601     Nichols, K. (1993) The Magnitude of Mepiquat Chloride Residues in Cotton Seed Based on Ultra-low
             Volume Aerial Applications: Lab Project Number:  R-92045: 93/5048: 9200537.  Unpublished study
             prepared by Harris Labs and American Agricultural Services, Inc. 177 p.

42734602     Nichols, K. (1993) The Magnitude of Mepiquat Chloride Residues in Cotton Seed Based on Low-rate
             Multiple Applications: Lab Project Number: A9307: 9200535: R-92044.  Unpublished study prepared
             by Harris Labs and American Agricultural Services, Inc.  200 p.

42892201     Burkey, J. (1993) Freezer Storage Stability of BAS 083 W in  Cottonseed and its Processed Commodities:
             (Mepiquat Chloride): Interim Report: Lab Project Number: 93/5047: 91140: A9305. Unpublished study
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43024701     Goetz,  A. (1993) Metabolism of (carbon 14)-BAS 083 W in Cotton (Gossypium hirsutum): Amended
             Report: Lab Project Number: M9016: M9203: M9203A. Unpublished study prepared by BASF Corp.
             87 p.

43150701     Munk,  R.  (1993) Avian Single Oral LD50 of Mepiquat Chloride to the Bobwhite Quail: Lab Project
             Number: 93/10694: 11W0697/90123. Unpublished study prepared by BASF Aktiengesellschaft.  41 p.

43155901     Munk,  R. (1993) Sublethal Toxic  Effects on the Rainbow Trout of  Mepiquat Chloride  in a Flow
             Through System (28 days):  Lab  Project Number:  93/10882: 42F0697/905167.  Unpublished study
             prepared by BASF Aktiengesellschaft.  53 p.

43155902     Schneider, E. (1993) Determination of the Chronic Toxicity of Mepiquat Chloride to the Water Flea
             (Daphnia magna) Straus: Lab Project Number:  93/10316: 1/90/1892/51/3.  Unpublished study prepared
             by BASF Aktiengesellschaft. 42 p.

43264401     Mellert, W.  (1994) The Toxicity of Mepiquat Chloride in Beagle Dogs-Administration Via the Diet Over
             4 Weeks: Lab  Project Number: 94/10283: 30D0112/89109.  Unpublished study prepared by BASF
             Aktiengesellschaft, Dept. of Toxicology.  220 p.

43264402     Mellert, W.  (1994) Chronic Toxicity Study with Mepiquat Chloride in Wistar Rats-Administration in the
             Diet for 24 Months: Lab Project Number: 94/10285: 71S0112/89091. Unpublished study prepared by
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                                                  78

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43264403     Mellert,  W.  (1994) Supplementary  Study of  the  Toxicity  of Mepiquat  Chloride  in Beagle
             Dogs-Administration Via the Diet Over 12 Months: Lab Project Number: 94/10282: 33D0001/92001.
             Unpublished study prepared by BASF Aktiengesellschaft, Dept. of Toxicology. 498 p.

43264404     Mellert, W. (1994) Carcinogenicity Study with Mepiquat Chloride in B6C3F1 Mice-Administration in
             the Diet for 24 Months: Lab Project Number: 94/10284: 80S0112/89107. Unpublished study prepared
             by BASF  Aktiengesellschaft, Dept. of Toxicology.  1080 p.

43290401     Grosshans, F. (1994) The Metabolism of Mepiquat Chloride in Lactating Goats—Reinvestigation of Liver
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43290402     Giese, U.  (1989) Dosing of Lactating Goats with (carbon 14)-Mepiquat Chloride for the Determination
             of Accountability: Lab Project Number: 89/10508: NA 89 9230.  Unpublished study prepared by
             NATEC.  23 p.

43290403     Panek, E. (1994) Dosing of Lactating Goat with (carbon 14) -Mepiquat Chloride for Determination of
             Accountability: Supplementary Report to Reg. Doc. #BASF 89/10508: Lab Project Number: 94/5078:
             M9420: 89/10508.  Unpublished study prepared by BASF Corp.  8 p.

43290404     Panek, E. (1994) Dosing of Lactating Goat with (carbon  14)  -Mepiquat Chloride for Further Isolation
             and Identification of Metabolites:  Supplementary  Report to  MRID 41585202: Lab Project Number:
             94/5079: M9419: 94/10045.  Unpublished study prepared by BASF Corp. lip.

43290405     Giese, U. (1994) Dosing of Lactating Goat with (carbon 14)  -Mepiquat Chloride for Further Isolation
             and Identification of Metabolites:  Addendum to  MRID 41585202: Lab  Project  Number:  94/10045:
             88/0616: NA 88 9726.  Unpublished study prepared by NATEC Institute.  7 p.

43378601     Hellwig, J.  (1993) Reproduction Toxicity Study with Mepiquat Chloride  in Rats: Continuous Dietary
             Administration  over 2 Generation: Lab Project Number: 93/10983. Unpublished study prepared by
             BASF Aktiengesellschaft Dept. of Toxicology.  1702 p.

43379501     Burkey, J.; White, M. (1994) Freezer Storage Stability of BAS 083 W in Cottonseed and its Processed
             Commodities: Lab Project Number: 91140: A9425: 94/5120.  Unpublished study prepared by BASF
             Corp.  74 p.

43396001     Mellert, W. (1994) Carcinogenicity Study with Mepiquat Chloride in Wistar Rats—Administration in the
             Diet for 24 Months: Lab Project Number:  94/10772:  71S0112/89092. Unpublished  study by BASF
             Altiengesellschaft.  1680 p.

43415401     Evans, J.; Anderson, S.  (1994) 1991 Ponnax Vineyard Soil Dissipation Study: Summary Report: Lab
             Project Number: 91007:  ER93024: 94/5150. Unpublished study prepared by BASF Corp.  771 p.
                                                  79

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43440301     Panek, E.; Kohl, W. (1994) Supplementary Information on Tissue Storage Conditions and Times For
             (carbon  14)-Mepiquat Chloride Goat  Metabolism Studies  (Mrid 42394301  and  42390405) and
             Accountability Studies  (Mrid 42394303 and Reg.  Doc. No. BASF 93/10672): Lab Project Number:
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43455801     Goetz, A.; Butterfield, A. (1994)  Further Identification Analysis of the (carbon 14) Residues Contained
             in the Soil Samples  Obtained During the (carbon 14)  BAS 083 W Rotational Crop Study (Study #
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             52 p.

43468701     Clark, J. (1994)  BASF Rebuttal to the Review  of Environmental Fate Studies  in Support of  the
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43468702     Burkey, J.; White,  M. (1994) Freezer Storage  Stability of BAS 083 W in Soil (25-Month Interval):
             Interim Report: Lab Project Number: 94/6155: 91150: A9449.  Unpublished study by BASF Agricultural
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43471001     Drottar, K.; Swigert,  J.; Holmes, C.  (1994) Mepiquat Chloride: A 48-Hour Static Acute Toxicity Test
             with the Cladoceran (Daphnia magna): Lab Project Number: 147A/118: 94030: ER94032. Unpublished
             study prepared by Wildlife International Ltd. and BASF Agricultural Research Center. 70 p.

43516701     Drottar, K.; Swigert,  J.; Holmes, C.  (1995) Mepiquat Chloride: A 96-Hour Static Acute Toxicity Test
             With the Sheepshead Minnow  (Cyprinodon variegatus): Lab  Project Number:  147A-121: 94034:
             ER94034.  Unpublished study prepared by Wildlife Int'l Ltd.; and BASF Corp.  66 p.

43516702     Drottar, K.; Swigert, J.; Holmes,  C.  (1995) Mepiquat Chloride: A 96-Hour Shell Deposition Test With
             the  Eastern  Oyster  (Crassostrea virginica):  Lab  Project Number: 147A-120A:  94035:  ER94053.
             Unpublished  study prepared by Wildlife Int'l Ltd.; and  BASF Corp.  71 p.

43516703     Drottar, K.; Swigert,  J.; Holmes, C.  (1995) Mepiquat Chloride: A 96-Hour Static Acute Toxicity Test
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             Unpublished  study prepared by Wildlife Int'l Ltd.; and  BASF Corp.  71 p.

43738601     Riley, M.; Sears, L. (1995) Meat and Milk Magnitude of Residue Study with Mepiquat Chloride in
             Lactating Dairy Cows: Lab Project Number: 95/5094: A9529: A9062. Unpub. study prepared by BASF
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43738602     Riley, M.; Sears, L.  (1995)  Meat  and Egg Magnitude of Residue Study with Mepiquat Chloride in White
             Leghorn Chickens:  Lab Project Number:  95/5095: A9063: A9539. Unpublished  study prepared by
             BASF Corp.  221 p.

43738603     Burkey, J.; Riley, M. (1995) Freezer Storage Stability of  BAS 083 W in Animal Tissues, Eggs and Milk:
             Lab Project Number: 95/5096: A9538: 91149. Unpublished study prepared by BASF Corp. 77 p.
                                                  80

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44102201     Hildebrand,  B.;  Merkle,   J.   (1981)   Study  to   Determine  the  Prenatal   Toxicity  of
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92091006     Kieczka, H. (1990) BASF Corporation Phase 3 Summary of MRID 00071942. Tolerance of the Rabbit
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92091008     Kieczka, H. (1990) BASF Corporation Phase 3 Summary of MRID 41488103.  Report on the Study of
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92091010     O'Reilley, I.  (1990) BASF Corporation Phase 3 Summary of MRID 00148089 and Related MRIDs
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             8 p.
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                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                      WASHINGTON, D.C. 20460
                                                                           OFFICE OF
                                                                     PREVENTION, PESTICIDES
                                                                      AND TOXIC SUBSTANCES
                               DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-in Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency).  These data are necessary to maintain the continued registration of
your product(s)  containing this active ingredient. Within 90 days after you receive this Notice
you must respond as set forth in  Section III below.  Your response must state:

       1.     How you will comply with the requirements set forth in this Notice and its
             Attachments 1 through 6; or

       2.     Why you believe you are exempt from the requirements listed in this Notice and
             in Attachment 3,  Requirements Status and Registrant's Response Form, (see
             section III-B);  or

       3.     Why you believe EPA should not require your submission  of product specific
             data in the manner specified by this Notice (see section III-D).

       If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration  of
your product(s)  subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
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       The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B).  Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 and 2070-0057 (expiration date 03-31-99).

       This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-in Notices. The Attachments contain
specific chemical information and instructions.  The six sections of the Notice are:

       Section I   -  Why You Are Receiving This Notice
       Section II -   Data Required By This Notice
       Section III -   Compliance With Requirements Of This Notice
       Section IV -   Consequences Of Failure To Comply With This Notice
       Section V -   Registrants' Obligation To Report Possible Unreasonable Adverse
                    Effects
       Section VI -   Inquiries And Responses To This Notice

The Attachments to this Notice are:

       1  -   Data Call-In Chemical Status Sheet
       2  -   Product-Specific Data Call-In Response Form
       3  -   Requirements Status and Registrant's Response Form
       4  -   EPA Batching of End-Use Products for Meeting  Acute Toxicology Data
             Requirements for Reregistration
       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 and reevaluated the
data needed to support continued registration of the subject active ingredient.  The Agency has
concluded that the only additional data necessary are product specific data.  No additional
generic data requirements are being imposed.  You have been sent this  Notice because you
have product(s) containing the subject active ingredient.

SECTION II.  DATA REQUIRED BY THIS  NOTICE

II-A.  DATA REQUIRED

       The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and  Registrant's Response Form.  Depending on the results of the studies
required in this Notice, additional testing may be required.

II-B.  SCHEDULE FOR  SUBMISSION OF DATA

   You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.

II-C.  TESTING PROTOCOL

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   All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.

       These EPA Guidelines are available from the National Technical Information  Service
(NTIS), Attn: Order Desk,  5285 Port Royal Road, Springfield, Va 22161  (tel: 703-487-4650).

       Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 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 160.3(a)(6)].

II-D.  REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
     ISSUED BY THE AGENCY

     Unless otherwise noted herein, this Data Call-In does not in any way supersede  or change the
requirements of any previous Data Call-In(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

III-A.  SCHEDULE FOR RESPONDING TO THE AGENCY

       The appropriate responses initially  required by this Notice  for product specific data must
be submitted to the Agency within 90 days  after your receipt of this Notice. Failure  to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to
failure to comply with this Notice are presented in Section IV-A and IV-B.

III-B.  OPTIONS FOR RESPONDING TO  THE AGENCY

       The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver (s).

       A discussion of how to  respond if you chose the Voluntary  Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C.  A discussion of options relating to
requests for data waivers is contained in Section III-D.

       There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency.  These forms are the Data-Call-in

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Response Form, and the Requirements Status and Registrant's Response Form, Attachment 2 and
Attachment 3. 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
must be submitted for each product listed on the Data Call-In Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-in Response Form in Attachment 2).  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.

       1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice.  If you wish to voluntarily cancel your product, you must submit a completed Data Call-in
Response Form, indicating your election of this option.  Voluntary cancellation is item number 5
on the Data Call-In  Response Form. If you choose this option, this is the only form that you are
required to complete.

       If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective  date of cancellation must be in accordance with the  Existing Stocks
provisions of this Notice which  are contained in Section IV-C.
       2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-in Response Form. Deletion of a use(s) and the low volume/minor use option are not valid
options for fulfilling product specific data requirements.

       3. Request for Product Specific Data Waivers.  Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option  7 on the Requirements Status
and Registrant's Response Form.  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.

III-C  SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

       If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or  7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form 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)

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       (2)     I have entered into an agreement with one or more registrants to develop data
             jointly (Cost Sharing)
       (3)     I have made offers to cost-share (Offers to Cost Share)
       (4)     I am submitting an existing study that has not been submitted previously to the
              Agency by anyone (Submitting an Existing Study)
       (5)     I am submitting or citing data to upgrade a study classified by EPA as partially
              acceptable and upgradeable (Upgrading a Study)
       (6)     I am citing an existing study  that EPA has classified as acceptable or an existing
              study that has been submitted but not reviewed by the Agency (Citing an Existing
              Study)

       Option 1, Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.

       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.  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  — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the products
in the group. The registration number of the product for which data will be submitted must be
noted in the agreement to cost  share by the registrant selecting this option.  If you choose to enter
into an agreement to share in the cost of producing the required data but will not be submitting
the data yourself, you must provide the name of the registrant who will be submitting the data.
You must also provide EPA with documentary evidence that an agreement has been formed. Such
evidence may be your letter offering to join in an agreement and the other registrant's acceptance
of your offer, or a written statement by the parties that an agreement exists.  The agreement to
produce the data need not specify all of the  terms of the final arrangement between the parties or
the mechanism to resolve the terms.  Section 3(c)(2)(B) provides that if the parties cannot resolve
the terms of the agreement they may resolve their differences through binding arbitration.
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       Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above.  If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to  meet the
requirements of this Notice and have been unsuccessful, you may request EPA  (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice.  EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration  of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the  data has refused to
accept your offer.  To qualify for this option,  you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data.  You must also submit to the Agency a completed
EPA Form 8570-32,  Certification of Offer to Cost Share in the Development of Data, Attachment
7. In addition, you must demonstrate that the other registrant to whom the offer was made has
not accepted your offer to enter into a cost sharing agreement by including a  copy  of your offer
and proof of the other registrant's receipt of that offer (such as a certified mail receipt).  Your
offer must, in addition to anything else, offer  to share in the burden of producing the data upon
terms to be agreed or failing agreement to be bound  by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii) and must not qualify this offer.   The other registrant must also inform EPA
of its election of an option to develop and submit the data required by this Notice by submitting a
Data Call-In Response Form 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 burdens of developing the  data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
to develop the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant will normally be subject to  initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.

       Option 4, Submitting an Existing Study — If you choose to submit an  existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice.  You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this  Notice.
Do not use this option if you are submitting data to upgrade a study.  (See Option 5).

       You should be aware that if the Agency determines that the study is not  acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid and
needs to be repeated.

       To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:

       a.      You must certify at the time that the existing study is submitted that the raw data
              and specimens from the study are  available for audit and review  and you must
              identify where they are available.  This must be done in accordance with the
              requirements of the Good Laboratory  Practice (GLP) regulation,  40 CFR Part 160.
              As stated in 40 CFR 160.3(j) "  'raw data'  means any laboratory worksheets,
              records, memoranda, notes, or  exact copies thereof, that are the result of original

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              observations and activities of a study and are necessary for the reconstruction and
              evaluation of the report of that study.  In the event that exact transcripts of raw
              data have been prepared (e.g.,  tapes which have been transcribed verbatim, dated,
              and verified accurate by signature), the exact copy or exact transcript may be
              substituted for the original source as raw data.  'Raw data' may include
              photographs, microfilm or microfiche copies, computer printouts, magnetic media,
              including dictated observations, and recorded data from automated instruments."
              The term "specimens", according to 40 CFR 160.3(k), means "any material
              derived from a test system for examination or analysis."

       b.      Health and safety studies completed after May 1984  must also contain all GLP-
              required quality assurance and  quality control information, pursuant to the
              requirements of 40 CFR Part 160.  Registrants  must also certify at the time of
              submitting the existing study that such GLP information is available  for post-May
              1984 studies by including an appropriate statement on or attached to the study
              signed by an authorized official or representative of  the registrant.

       c.      You must certify that each study fulfills  the acceptance criteria for the  Guideline
              relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
              Technical Guidance and that the study has been conducted according to the
              Pesticide Assessment Guidelines (PAG) or meets  the purpose of the PAG (both
              available from NTIS). A study not conducted according to the PAG may be
              submitted to the Agency for consideration if the registrant believes that the study
              clearly meets the purpose of the PAG. The registrant is referred to 40 CFR 158.70
              which states the Agency's policy regarding acceptable protocols. If you wish to
              submit the study, you must, in  addition to certifying that the purposes of the PAG
              are met by the study, clearly articulate the rationale  why you believe the study
              meets the purpose of the PAG, including copies of any supporting information or
              data.  It has  been the Agency's experience that studies completed prior to January
              1970 rarely satisfied the purpose of the PAG and that necessary raw data are
              usually not available for such studies.
       If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.

       If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study.  If such  study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.

       Option 5, Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study.  The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental.  However, it is
important to note that not  all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1.  If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies  in the study identified by EPA.  You

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must provide a clearly articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number(s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.

       Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.

       This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency.  You must provide the MRID number of
the data submission as well  as the MRID number of the  study being upgraded.

       The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies.  Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria as well as a certification regarding protocol compliance with Agency requirements.

       Option 6, Citing Existing Studies — If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it
must be a study which has not yet been reviewed by the Agency.  Acceptable toxicology studies
generally will have been classified as "core-guideline" or "core minimum."  For all other
disciplines the classification would be "acceptable." With respect to any studies for which you
wish to select this option you must provide the MRID number  of the study you are citing and, if
the study has been reviewed by the Agency, you must provide  the Agency's classification of the
study.

       If you are  citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.

       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, as appropriate.

III-D  REQUESTS FOR DATA WAIVERS

             If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical
reasons, data and  references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be the
only opportunity to state the reasons or provide information in support of your request.  If the
Agency approves your waiver request, you will not be required to supply the data pursuant to
section 3(c)(2)(B)  of FIFRA.  If the Agency denies your waiver request, you must choose an
option for meeting the data  requirements of this Notice within  30 days of the receipt of the
Agency's decision.  You must indicate and submit the option chosen on the  Requirements Status
and Registrant's Response Form. Product specific data requirements for product chemistry, acute
toxicity and efficacy (where appropriate) are required for all products  and the Agency would grant
a waiver only under extraordinary circumstances.  You should also be aware that submitting a
waiver request will not automatically extend the due date for the study in question.  Waiver
requests submitted without adequate supporting rationale will be denied and the original due date
will remain in force.

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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:

             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.
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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 would generally not
be consistent with the Act's purposes. Accordingly,  the Agency anticipates granting registrants
permission to sell,  distribute, or use existing  stocks of suspended product(s) only in exceptional
circumstances.  If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would  be consistent with the Act. You
must also  explain why an "existing stocks" provision is necessary,  including a statement  of the
quantity of existing stocks and your estimate  of the time required for their sale, distribution, and
use.  Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution,  or use of your existing stocks after suspension.

       If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks.  Normally,  the Agency will allow persons other than the
registrant  such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which  the Agency has particular
risk concerns will be determined  on case-by-case basis.
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       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.

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.
                                           93

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       All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified in Attachment 1.  If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-in Response Form need be submitted.

       The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances  (OPTS), EPA, will be monitoring the data being generated  in response to this Notice.

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

       1  -   Data Call-in Chemical Status Sheet
       2  -   Product-Specific Data Call-in Response Form
       3  -   Requirements Status and Registrant's Response Form
       4  -   EPA Batching of End-Use Products for Meeting Acute Toxicology Data
             Requirements for Reregistration
       5  -   List of Registrants Receiving This Notice
       6  -   Cost Share and Data Compensation Forms and the Confidential Statement of
             Formula Form
                                            94

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MEPIQUAT CHLORIDE DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

      You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing mepiquat chloride.

      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 reregistration of mepiquat
chloride.  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 mepiquat chloride 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 mepiquat chloride are
contained in the Requirements Status and Registrant's Response, Attachment 3.  The Agency has
concluded that additional data on mepiquat chloride 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 reregistration of all  eligible mepiquat chloride 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 Emily Mitchell at (703) 308-8583.

      All responses to this Notice for the Product Specific data requirements should be submitted
      to:
             Emily Mitchell
             Chemical Review Manager Team 81
             Product Reregistration Branch
             Special Review and Reregistration Branch 7508W
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C. 20460

             RE: mepiquat chloride
                                          95

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  INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
                             PRODUCT SPECIFIC DATA

Item 1-4.     Already completed by EPA.

Item 5.       If you wish to voluntarily cancel your product, answer "yes."  If you choose this
             option, you will not have to provide the data required by the Data Call-In Notice and
             you will not have to complete any other forms.  Further sale and distribution of your
             product after the effective date of cancellation must be in accordance with the Existing
             Stocks provision of the Data Call-In Notice (Section IV-C).

Item 6.       Not applicable since this form calls in product specific  data only.  However, if your
             product is identical to another product and you qualify for a data exemption, you
             must respond with "yes" to Item 7a (MUP) or 7B  (EUP)  on this form, provide the
             EPA registration  numbers  of your source(s);  you would  not complete the
             "Requirements Status and Registrant's Response" form. Examples of such products
             include repackaged products and Special Local Needs (Section 24c)  products which
             are identical to federally registered products.

Item 7a.      For each  manufacturing use product (MUP) for which you wish to  maintain
             registration, you must agree to satisfy the data requirements by responding "yes."

Item 7b.      For each end use product (EUP) for which you wish to maintain registration, you
             must agree  to satisfy the data requirements by  responding "yes."  If you are
             requesting a data waiver, answer "yes" here; in addition, on  the "Requirements
             Status and  Registrant's Response" form under Item 9, you must respond with Option
             7 (Waiver  Request) for each study for which you are requesting a waiver.  See Item
             6 with regard to identical products and data exemptions.

Items 8-11.  Self-explanatory.

NOTE:       You may provide additional information that does not fit on this form in a signed
             letter that accompanies this form.  For example, you  may wish to report that your
             product has already been  transferred to another company or that you have already
             voluntarily canceled this product. For these cases,  please  supply all relevant details
             so that EPA can ensure that its records are correct.
                                          96

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97

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98

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       INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
         REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA

Item 1-3      Completed by EPA. Note the unique identifier number assigned by EPA in Item
             3.  This number  must  be  used in the transmittal document for  any data
             submissions in response to this Data Call-In Notice.

Item 4.       The  guideline reference  numbers of studies  required to support the  product's
             continued registration are identified.  These guidelines, in addition to the requirements
             specified in the Notice, govern the conduct of the required studies. Note that series
             61 and 62 in product chemistry are now listed  under 40 CFR  158.155 through
             158.180,  SubpartC.

Item 5.       The study title associated with the guideline reference number is identified.

Item 6.       The use pattern(s) of the pesticide associated with the product specific requirements
             is (are) identified.  For most product specific data requirements, all use patterns are
             covered by the data requirements.  In the case of efficacy data, the required studies
             only pertain to products which have the use sites and/or pests indicated.

Item 7.       The substance to be tested is identified by EPA.  For product  specific data, the
             product as formulated  for sale and distribution is the test substance, except in rare
             cases.

Item 8.       The due date for submission of each study is identified. It is normally based on 8
             months after issuance of the Reregistration Eligibility Document unless EPA
             determines that a longer time period is necessary.

Item 9.       Enter only one of the following response codes for each data requirement to show
             how you intend to comply with the data requirements listed in this table.  Fuller
             descriptions of each option are contained in the Data Call-In Notice.

       1.     I  will generate and submit data by the specified due date  (Developing Data).  By
             indicating that I have  chosen  this  option, I certify that I will comply with  all the
             requirements pertaining to the conditions for submittal of this study as outlined in the
             Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
             "Certification With Respect To Data Compensation  Requirements" form (EPA
             Form  8570-29) and (2)  two  completed and  signed  copies of  the  Confidential
             Statement of Formula (EPA Form 8570-4).

       2.     I  have entered into an agreement with one or more registrants to develop data jointly
             (Cost Sharing).  I  am submitting a copy of this agreement.  I understand that this
             option is  available only for acute toxicity or certain efficacy data and only if EPA
             indicates in an attachment to this Notice that my product is similar enough to another
             product to qualify for this option.  I  certify that another party in the agreement is
             committing to submit or provide  the required data;  if the required study is not
             submitted on time,  my product may be subject to suspension. By the specified due
             date,  I will also submit:  (1)  a completed "Certification  With Respect To Data
                                           99

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       Compensation Requirements" form (EPA Form 8570-29) and (2) two completed
       and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).

3.      I have made offers to share in the cost to develop data (Offers to Cost Share).  I
       understand that this option is available only for acute toxicity or certain efficacy data
       and only if EPA indicates in an attachment to this Data Call-in Notice that my product
       is similar enough to another product  to qualify  for this option.  I am submitting
       evidence that I have made an offer to another registrant (who has an obligation to
       submit data) to share in the cost of that data.  I am also submitting a completed
       "Certification of Offer to Cost Share in the Development Data" form.  I am
       including a copy of my offer and proof of the other registrant's receipt of that offer.
       I am identifying the party which is committing to submit or provide the required data;
       if the required study is not submitted on time, my product may be subject to
       suspension.  I understand that other terms under Option 3 in the Data Call-in Notice
       (Section III-C.l.) apply as well.  By the specified due date, I will also submit: (1) a
       completed "Certification With Respect To Data Compensation Requirements"
       form  (EPA Form 8570-29)  and  (2)  two  completed and signed copies of the
       Confidential Statement of Formula (EPA Form 8570-4).

4.      By the specified due date, I will submit  an existing study that has not been submitted
       previously to the Agency by anyone (Submitting an Existing Study). I certify that
       this study will meet all the requirements for submittal  of existing data outlined in
       Option 4 in the Data Call-In Notice (Section III-C.l.)  and  will meet the  attached
       acceptance criteria (for acute toxicity and product chemistry data).  I will attach the
       needed supporting information along with this response. I also certify that I have
       determined that this study will fill the data requirement  for which I have indicated this
       choice.  By the specified due date, I will also submit a completed  "Certification With
       Respect To Data Compensation Requirements" form (EPA Form 8570-29) to
       show what data compensation option I have chosen. By the specified due date, I  will
       also submit: (1)  a completed "Certification  With Respect To Data Compensation
       Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
       of the Confidential Statement of Formula (EPA Form 8570-4).

5.      By the specified due date,  I will submit or cite data to upgrade a study classified by
       the Agency as partially acceptable and upgradable  (Upgrading a Study).  I  will
       submit evidence of the Agency's review indicating that the study may be upgraded
       and what information is required to do so.  I will provide the MRID or Accession
       number of the study at the due date. I  understand that the conditions for this option
       outlined  Option 5  in the Data  Call-In Notice  (Section III-C.l.) apply.  By the
       specified due date, I will also submit: (1) a completed "Certification With  Respect
       To Data  Compensation Requirements"  form (EPA Form 8570-29) and (2)  two
       completed and signed copies of the Confidential Statement of Formula (EPA Form
       8570-4).

6.      By the specified due date, I will cite an existing study that the Agency has classified
       as acceptable  or an existing study that has been submitted but not reviewed by the
       Agency  (Citing an Existing Study).   If I  am citing another registrant's  study, I
       understand that this option is available only for acute toxicity or certain efficacy data
       and only  if  the cited study was conducted on my  product, an identical product or a
                                    100

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             product which EPA has "grouped" with one or more other products for purposes of
             depending on the same data.  I may also choose this option if I am citing my own
             data.  In either case, I will provide the MRID or Accession number(s) for the cited
             data on a "Product Specific Data Report" form or in a similar format.   By the
             specified due date,  I will also submit:  (1) a  completed "Certification With Respect
             To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
             completed and signed copies of the Confidential Statement of Formula (EPA Form
             8570-4).

       7.     I request a waiver for this study because it is inappropriate for my product (Waiver
             Request).  I am attaching a complete justification for this request, including technical
             reasons, data and  references to relevant EPA regulations, guidelines or policies.
             [Note: any supplemental data must be submitted in the format required by P.R. Notice
             86-5]. I understand that this is my only opportunity to state the reasons or provide
             information in support of my request.  If the Agency approves my waiver request, I
             will not be required to supply the data pursuant to Section 3(c)(2)(B) of FIFRA.  If
             the Agency denies  my waiver request, I must choose a method of meeting the data
             requirements of this Notice by the due date stated by this Notice.  In this case, I must,
             within 30 days of my receipt  of the Agency's written decision,  submit a revised
             "Requirements Status and Registrant's Response" Form indicating the option chosen.
             I also understand that the deadline for submission of data as specified by the original
             data call-in notice will not change.  By the specified due date, I will also submit: (1)
             a completed "Certification With Respect To Data Compensation Requirements"
             form  (EPA  Form 8570-29)  and (2)  two completed and signed copies of the
             Confidential Statement of Formula (EPA Form 8570-4).

Items 10-13.  Self-explanatory.

NOTE:      You may provide additional information  that does not fit on this form in a signed
             letter that accompanies this form.  For example, you may wish to report that your
             product has already been transferred to another company or that you have already
             voluntarily canceled this product. For these cases, please supply all relevant details
             so that EPA can ensure that its  records are  correct.
                                           101

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102

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103

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104

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105

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106

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           EPA'S BATCHING OF MEPIQUAT PRODUCTS FOR MEETING
        ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION

       In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregi strati on of products containing the active ingredient Mepiquat
the Agency has batched products which can be considered similar for purposes of acute toxicity.
Factors considered in the sorting process include each product's active and inert ingredients (identity,
percent composition and biological activity), type  of formulation (e.g., emulsifiable concentrate,
aerosol, wettable  powder, granular, etc.), and labeling (e.g., signal word, use classification,
precautionary labeling, etc.).  Note  that the Agency  is not describing batched products as
"substantially similar" since some products within a batch may not be considered chemically similar
or have identical use patterns.

       Using available information, batching has been accomplished by the process described in the
preceding paragraph.  Notwithstanding the  batching  process, the Agency reserves the right to
require, at any time, acute toxicity  data for an individual product should the need arise.

       Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute toxicological studies to represent all the products within that batch. It
is the registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only  their own products within a batch,  or  to generate all  the required acute
toxicological studies for each of their own products.  If a registrant chooses to generate the data for
a batch, he/she must use one of the products within the  batch as the test material. If a registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the
data base  is complete  and valid  by today's  standards (see acceptance criteria attached), the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the  acute toxicity data. Regardless
of whether new data is generated or existing data is referenced, registrants must clearly identify the
test material by EPA Registration Number.  If more than one confidential statement of formula
(CSF) exists for a product, the registrant must indicate the formulation actually tested by identifying
the corresponding CSF.

       In deciding how to meet the  product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to  the RED.  The DCI
Notice contains two response forms which are to be completed and submitted to the Agency within
90 days of receipt. The first form,  "Data Call-In Response," asks whether the registrant will meet
the data requirements for each product.  The second form, "Requirements Status and Registrant's
Response," lists the product specific data required for each  product, including the standard six acute
toxicity tests. A registrant who wishes to participate in  a batch must decide whether he/she  will
provide the data or depend on someone else to do so.  If  a registrant supplies the data to  support a
batch of products, he/she must select one  of the following options: Developing Data (Option 1),
Submitting an Existing Study (Option 4), Upgrading  an Existing Study (Option 5) or Citing an
Existing Study (Option 6). If a registrant depends  on another's data, he/she must choose among:
Cost Sharing (Option 2), Offers to Cost Share  (Option 3) or Citing an Existing Study (Option 6).
If a registrant does not want to participate in a batch, the choices are Options 1,  4, 5 or 6.  However,
a registrant should know that choosing not to participate in a batch does  not preclude other
registrants in the batch from citing his/her studies and offering to cost share (Option 3) those studies.
                                           107

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       All these 9 products contain only one active ingredient, mepiquat, N,N-dimethylpiperidinium
chloride.

       The first table batches the two technicals. Data is available on the acute toxicity of a pure
technical.  No further testing of the technicals is required.
BATCH
NO.
1
EPA REG. NO.
51036-187
51036-191
% of Mepiquat
99.0
99.0
Formulation Type
Liquid
Liquid
BATCH
NO.
2
EPA REG. NO.
7969-97
51036-189
% of Mepiquat
22.5
23.5
Formulation Type
Liquid
Liquid
       The compounds below have the same concentration of mepiquat (4.2%) and are batched
together. It may be possible to bridge from the above batch.
BATCH
NO.
3
EPA REG. NO.
7969-52
10136-186
51036-189
66996-1
% of Mepiquat
4.2
4.2
4.2
4.2
Formulation Type
Liquid
Liquid
Liquid
Liquid
       Only one product, 7969-107, remained unbatched. However, this product does have some
acceptable studies in EPA's files.
                                          108

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Attachment  5.     List of All Registrants Sent This Data Call-In (insert) Notice
                                          109

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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.
                                          110

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111

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112

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                     United States  Environmental Protection Agency
                                  Washington, B.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 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)
                                                113

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114

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EPA Form 8570-32 (5/91) Replaces EPA form 8580 which is obselete
                         United States Environmental Protection Agency
                                      Washington, DC 20460
                          CERTIFICATION WITH RESPECT TO
                       DATA COMPENSATION REQUIREMENTS
                                                                                          \
Form Approved
OMB No. 2070-0107,
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
Product Name
Company Number
EPA Reg. No.
  I Certify that:

  1.   For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
  (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
  data submitter to cite that study.

  2.   That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
  original data submitter,  or I have obtained the written permission of the original data submitter, or I  have notified in writing the
  company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those  data in accordance with sections
  3(c)(1 )(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
  requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)

   [ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
  "Requirements Status and Registrants' Response Form,"

  3.   That I  have previously complied with  section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
  reregistration under FIFRA.
Signature
Date
  Name and Title (Please Type or Print)
  GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
  reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
  Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
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    The following is a list of available documents for mepiquat chloride that my further assist you
in responding to this Reregistration 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  be downloaded from the Pesticide Special Review
             and Reregistration Information System at 703-308-7224. They also are available
             on the Internet on EPA's gopher server, GOPHER.EPA.GOV, or using ftp on
             FTP.EPA.GOV, or using WWW (World Wide Web) on WWW.EPA.GOV., or
             contact Dee Henderson at (703)-308-8167.

    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 mepiquat chloride.


    The following  documents are part of the Administrative Record for mepiquat chloride 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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