oEPA
            United SUM*
            Environments! Protection
            Agtncy
            Off to of
            Ptrtteidw and TwcJc SubctanoM
            Washington DC 20460
September 1988
540/RS-88-128
           P«ticidw
Guidance for the
Reregistration of
Pesticide Products
Containing ETHEPHON
as the Active Ingredient

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                        TABLE OF CONTENTS
    •\

I.    Introduction	1

II.   Chemical(s) Covered by this Standard	4
        A.  Description of Chemical
        B.  Use Profile

III.  Agency Assessment	5
        A.  Summary
        B.  Preliminary Risk Assessment
        C.  Other Science Findings
        D.  Tolerance Reassessment

IV.   Regulatory Position and Rationale	21
        A.  Regulatory Positions
        B.  Criteria for Registration
        C.  Acceptable Ranges and Limits
        D.  Required Labeling

V.    Products Subject to this Standard	30

VI.   Requirement for Submittal of Generic Data	32
        A.  What are generic data?	32
        B.  Who must submit generic data?	32
        C.  What generic data must be submitted?	33
        D.  How to comply with DCI requirements	33
        E.  Registrant Requests Regarding Data
            Requirements and Agency Responses	36
        F.  Test Protocols and Standards	36
        G.  Procedures for requesting a change in protocol.  .  37
        H.  Procedures for requesting extensions  of time.  .  .  37
        I.  Data Format and Reporting Requirements	37
        J.  Existing stocks provisions upon suspension or
            cancellation	38

VII.  Requirement for Submittal of Product-Specific Data  .  .  38

VIII.  Requirement for Submittal of Revised Labeling	39

IX.   Instructions for Submittal	39
        A.  Manufacturing use products (sole active)
        B.  Manufacturing use products (multiple  active)
        C.  End use products (sole active)
        D.  End use products (multiple active)
        E.  Intrastate products

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                                      SEP 29
          GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS

             CONTAINING

              ETHEPHON


      AS THE ACTIVE INGREDIENT


          CASE NUMBER 0382

       CAS NUMBER 16672-87-0

        Chemical Code 099801


           September 1988
  ENVIRONMENTAL PROTECTION AGENCY

    OFFICE OF PESTICIDE PROGRAMS

      WASHINGTON, D.C.  20460

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             GLOSSARY OF TERMS AND ABBREVIATIONS

ADI     Acceptable  Daily Intake.  Also known as the Reference
        Dose or RfD.

a.i.    active ingredient

ARC     Anticipated Residue Contribution

CAS     Chemical Abstracts Service

CSF     Confidential Statement of Formula

EEC     Estimated Environmental Concentration.  The estimated
        pesticide concentration system in an environment,
        such as a terrestrial ecosystem.

EP      End Use Product

EPA     U.S. Environmental Protection Agency

FIFRA   Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA   Federal Food, Drug, and Cosmetic Act

FR      Federal Register

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 or feed, e.g., mg/1 or ppm.

LD50    Median lethal dose - a statistically derived single dose
        than 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.

LOT     Lowest Dose Tested

LEL     Lowest Effect Level

MP      Manufacturing Use Product

MPI     Maximum Permissible Intake

MRID    Master Record Identification (number).  EPA's system  of
        recording and tracking studies submitted to the Agency.
                                 ill

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                           APPENDICES

I.  DATA APPENDICES

    Guide to Tables

    Table A

    Table B

II.  LABELING APPENDICES

     Summary of label requirements and table

     40 CFR 156.10 Labeling Requirements (162.10)

     Physical/Chemical Hazards Labeling Statements

     Storage Instructions

     Pesticide Disposal Instructions

     Container Disposal Instructions


III.  BIBLIOGRAPHY APPENDICES

     Guide to Bibliography

     Bibliography


IV.  FORMS APPENDICES

EPA Form 8580-1   FIFRA 53(c)(2)(B) Summary Sheet

EPA Form 8580-3   Generic Data Exemption Statement

EPA Form 8580~-4   Product Specific Data Report
EPA Form 8580-6
Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
                                  11

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                             -1-

                       I.   INTRODUCTION

     EPA has established the Registration  Standards program
 in order to provide an orderly mechanism by which pesticide
 products containing the same active ingredient can be reviewed
 and standards set for compliance with  FIFRA.  The standards
 are applicable to reregistration and future applications for
 registration of products containing the same active ingredient.
 Each registrant of a product containing an active ingredient
 subject to this Standard who wishes to continue  to sell or
 distribute that product must bring  his product and labeling
 into compliance with FIFRA, as instructed  by this Standard.

     The Registration Standards program 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" criteria of FIFRA. In its review EPA identifies:

     1.  Studies that are acceptable to support  the data
 requirements for the currently registered  uses of the pesticide.

     2.  Additional studies necessary  to support continued
 registration.  The additional studies  may  not have been
 required when the product was initially registered or may be
 needed to replace studies that are  now considered inadequate.

     3.  Labeling revisions needed  to  ensure that the product
 is not misbranded and that the labeling is adequate to protect
 man and the environment.

     The detailed scientific review, which is not contained
 in this document, but is available  upon request^, focuses on
 the pesticide active ingredient. The  scientific review
 primarily discusses the Agency's evaluation of and conclusions
 from available data in its files pertaining to the pesticide
active ingredient.  However, during the review of these data
 the Agency is also looking for potential hazards that may be
associated with the end use products that  contain the active
 ingredient.   The Agency will apply  the provisions of this
 Registration standard to end use products  if necessary to
 protect man and the environment.
     scientific reviews and Compendium of  Uses may be obtained
 from the National Technical Information Service (NTIS),
 Attr.:   Order Desk, 5285 Port Royal Road,  Springfield, VA
 22161.   Tel: (703) 487-4650.

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MTD     Maximum Tolerated Dose

NPDES   National Pollutant Discharge Elimination System

NOEL    No Observed Effect Level

OPP     Office of Pesticide Programs

OES     Office of Endangered Species, U.S. Fish and Wildlife
        Service

PADI    Provisional Acceptable Daily Intake

ppm     parts per million

RBC     Red Blood Cell (s)

RfD     Reference Dose

TAS     Tolerance Assessment System

TMRC    Theoretical Maximal Residue Contribution
                                  IV

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                             -2-

     EPA's reassessment results in  the development of a
 regulatory position, contained  in this Registration Standard,
 on the pesticide and each of its registered  uses.  See
 Section IV - Regulatory Position and  Rationale.  Based on its
 regulatory position, the Agency may prescribe a variety of
 steps to be taken by registrants to maintain their registrations
 in compliance with FIFRA.  These steps may  include:

     1.  Submittal of data in support of product registration;

     2.  Modification of product labels;

     3.  Modifications to the manufacturing  process of the
 pesticide to reduce the levels  of impurities or contaminants;

     4.  Restriction of the use of  the pesticide to certified
 applicators or other specially  trained individuals;

     5.  Modification of uses or formulation types; or

     6.  Specification of packaging limitations.

     Failure to comply with these requirements may result in
 the issuance of a Notice of Intent  to Cancel or a Notice of
 Intent to Suspend (in the case  of failure  to submit data).

     In addition, in cases in which hazards to man or the
 environment are identified, the Agency may  initiate a special
 review of the pesticide in accordance with  40 CFR Part 154
 to examine in depth the risks and benefits  of use of the
 pesticide.   If the Agency determines  that  the risks of the
 pesticide's use outweigh the benefits of use, the Agency
 may propose additional regulatory actions,  such as cancellation
 of uses of  the pesticide which  have been determined to cause
 unreasonable adverse effects on the environment.

     EPA has authority under the Data Call-in  (DCI) provisions
 of FIFRA sec. 3(c)(2)(B) to require that registrants submit
 data to answer our questions regarding the  chemical, toxicological,
 and environmental characteristics and fate  of a pesticide.
 This Registration Standard lists the  data  EPA believes are
 necessary to resolve our concerns about  this pesticide.
 These data  are listed in the Tables A, B, and c in Appendix  I.
 Failure to  comply with the DCI  requirements enumerated in
 this Registration Standard may  result in issuance by EPA of a
 Notice of Intent to Suspend the affected product  registrations.

     Registrants are reminded that  FIFRA sec. 6(a)(2) requires
 therr to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any  time  that they
become aware of such information.  Registrants must  notify

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                            -3-
the Agency of any information,  including interim
results of studies/  if  that  information suggests
adverse effects on man  or  the  environment.  This
is independent of the specific  time requirements
EPA for submittal of completed  studies called in
Agency and continues as long as the products are
under FIFRA.
or preliminary
possible
requirement
imposed by
by the
registered

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II.
CHEMICAL COVERED BY THIS STANDARD

A.   Description of Chemical

                      :   Ethephon
          Common Name
            (ANSI)
          Chemical Name
          Empirical Formula

          Molecular Weight

          Physical State

          Color

          Melting Point

          Solubility



          Trade Name



          OPP/Shaugnessy No.

          CAS Registry No.
                         (2-Chloroethyl)
                         Phosphonic  acid

                         C2H6CL03P

                         144.5

                         Waxy,  solid

                         White

                         74  to  75C

                         Very soluble  in  water, alcohol,
                         propylene glycol;  slightly
                         soluble in  aromatic  solvents

                         Bromeflor,  Cerone, Chlorethephon
                         (N.  Zealand),  Ethrel,  Florel, Prep,
                         and  Flordimex

                         099801

                         16672-87-0
          Wiswesser Line-Formula Notation:   QPQ02G

          Date of Initial Registration:  1973

          Ethephon was discovered in 1965 and introduced
commercially in 1973 by the AmChem/Union Carbide Company for
inducing flowers on pineapples in Hawaii.  At the present time,
Rhone-Poulenc is the only registrant of ethephon, having purchased
Union Carbide's registrations.

          The following data have been required under Section
3(c)(2)(B) Of FIFRA:
               STUDY

          Oncogenicity Study
          species other than rat

          Teratogenic ity Study
          species other than rat
                                           DUE DATE

                                           March  1989
                                           May 1987
                                           (submitted)

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          The regulatory conclusions  regarding the teratogenicity
study are discussed in part  III  (Agency Assessment).


      B.  Use Profile

          Ethephon, a plant  growth  regulator that generates
ethylene gasf is used on many  crops to promote fruit ripening,
abscission, flower induction,  breaking of apical dominance,
and many other plant responses.   Ethephon is applied broadcast
to plant foliage by ground or  aerial  equipment when the plant is
reaching maturity, usually the pre-flower stage.  Ethephon releases
the natural plant hormone ethylene  after application and the
ethylene produces the growth effects  in the plants.

          Cotton, tomatoes,  grapes, and tobacco account for 98%
of the current use of ethephon in agriculture (approximately
1,135,000 acres).  Other sites include apples, barley, wheat,
blackberries, boysenberry, blueberry, cantaloupe, cherry (tart
and sweet), cucumber, squash and  pumpkin (hybrid seed production),
figs, cucumber (pickling),  filberts,  lemon, tangerine, tangelo,
pepper, pimento, walnut, ornamentals, guava, grapes for table
and raisin production, pineapples,  sugarcane, coffee beans,
cottonseed, macadamia nuts,  trees (forest and shelterbelt) and
cranberries.

          Application rates  vary  from 0.08 to 2.0 pounds of active
ingredient per acre depending  upon  the use site and desired
effects.

          There are two emulsifiable  concentrates,  seven soluble
concentrates/liquids, and two  ready-to-use liquids  available
for crop use.  There is one  98%  active ingredient technical
product.

          Rhone-Poulenc is currently  the  sole manufacturer of
the technical product and formulator  of  the  end-use products  in
the U.S.A.
III.  AGENCY ASSESSMENT

      The Agency has conducted a thorough review of  the scientific
data base available for ethephon.  This part of the  standard  sets
forth the results of that review.

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       A.  Toxicoloqical Assessmerrt

          1.  Acute Oral, Dermal and inhalation  Toxicity

              Acute toxicity studies show that via  the oral and
dermal  routes, ethephon is relatively non-toxic  except in hens
(see oral neurotoxicity study).  An acute study  with  rats showed
an oral LDsg of 1.6 g/kg (Toxicity Category III).   An acute
dermal  study using rabbits showed a dermal LDso  of  >  5 g/kg
(Toxicity Category III).  No adequate data are available on the
acute  inhalation properties of ethephon.   Acute  inhalation data
is required (refer to Table A of this document).

          2.  Irritation and Sensitization (dermal  and eye)

              Sufficient data are available to show that the
technical grade of ethephon is extremely  irritating to the
skin.   Based upon an acceptable primary dermal irritation
study  in rabbits, ethephon has been placed in Toxicity Category
I for  this effect.

              There are no acceptable data on the primary
eye irritation effects of ethephon.  However, ethephon is presumed
to be  extremely irritating; (corrosive) to the eyes  (Toxicity
Category I irritant), based OK the primary skin  irritation
study described above which indicates that ethephon is corrosive.
An eye  irritation study is not teqired.

               No data are available on the dermal  sensitization
properties of ethephon.

          3.  Acute Delay>ed Oral Neurotoxicity

              Ethephon was found to be acutely toxic  in  the hen
with an LD$Q of 3.8 g/kg.  No dose related neuro-histopathology
was detected in the hens after 42 days at acute  dose levels.

          4.  Subchronic Toxicity

              NO adequate data are available on  subchronic oral
toxicity in rats or dogs.  However, the requirement for  subchronic
studies in the rodent and non-rodent will be waived if the  required
chronic studies are acceptable.  There are two supplementary
studies, one for the rat and one for dogs, neither  of which
demonstrated a NOEL.

           Rat:

              In the rat study, ethephon  was administered by
gavage for 13 weeks to 20 rats per sex per dose level at 0,  50,
100,  and 200 mg/kg/day.  Plasma cholinesterase and  brain cholines-
terase activity were found to be statistically significantly
different from the controls at all dose levels.   Red blood  cell
cholinesterase activity did not differ from the controls in  any
dose group of males or females.

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              Dog;

              In the dog  study,  ethephon was administered in the
food to 4 dogs per  sex  per dose  level at 0, 5.0, 25.0 and 187.5
mg/kg/day for 13 weeks.   Plasma  cholinesterase activity was
statistically significantly  depressed in both males and females
at all dosage levels.   Red blood cell cholinesterase activity
was statistically significantly  depressed  in the males (at all
dose levels except  5.0  mg/kg/day at 8 weeks) and at the 25.0 and
187.j mg/kg/day dose levels  in the females.  Brain cholinesterase
activity was statistically significant only in females dosed at
187.5 mg/kg/day.

              A subchronic dermal test is  also required (21-days)
because no data are available.   A special  smoke inhalation
study (21-day) is required because the existing study is supplemen-
tary and ethephon is registered  for use on tobacco.

          5.  Chronic Toxicity and Oncoqenicity

              Chronic Toxicity
are not
rodent.
      The
adequate.


      Rat:
available chronic  toxicity  data  for  ethephon
 Studies are required  for  the  rodent and non-
              An available rat study  is  supplementary because
data were not submitted on the stability of  ethephon in the feed,
and historical control data were not  submitted on  the incidence
of pancreatic islet cell adenomas and carcinomas.  Dose related
non-oncogenic effects were limited to plasma and red blood cell
cholinesterase inhibition in the highest dose  tested (HOT).  This
inhibition was statistically significant in  males  and females for
red blood cells only.  The NOEL for cholinesterase activity
effects in this study is 15 mg/kg/day.   This study may be upgraded
if the data on the stability of ethephon in  the  feed and the
historical control data are submitted and  found  to be acceptable.

              Dog:

              An available dog study  is  supplementary because
no NOEL was demonstrated and data were not submitted on  the
stability of ethephon in the feed.  Red  blood  cell cholinesterase
activity was depressed only at the two highest dose  levels 50 and
75 mg/kg/day.  75 mg/kg/day was given to the dogs  only  from weeks
0 to 3 then the dosage was reduced to 50 mg/kg/day to  these animals
for weeks 4 and 5, and further reduced to  25 mg/kg/day  for the
remainder of the study.  In the study there were two,  apparently
different, sources of the chemical tested  and  reported  as  source
A a nd so u re e B.

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                                8

              For Source A ethephon,  reduced body weights were
observed with a NOEL of 7.5 mg/kg/day.  A NOEL for this effect
was not demonstrated for source B  ethephon.  This study may be
upgraded if the data on the stability of ethephon in the feed is
submitted and found to be acceptable.

              Mouse:

              In a supplementary chronic toxicity/oncogenicity study,
Swiss Albino mice, 85 per sex  per  group were fed diets containing
0, 4.5, 45, and 150 mg/kg/day  of ethephon for 78 weeks.  No
stability data on ethephon in  the  feed were submitted, if collected.
The oncogenic effects observed in  this study are reported in the
oncogenicity data discussion.   The following chronic effects were
observed in this study:

              Inhibition of plasma cholinesterase activity was
significant at the 45 and 150  mg/kg/day dose levels in males and
females.  The NOEL for plasma  cholinesterase activity is 4.5 mg/
kg/day for both sexes and the  LEL  for this effect was 45 mg/kg/
day for both sexes.

              There appeared to be a  dose related decrease in
red blood cell (RBC) cholinesterase activity in females.  There
was significant depression in  RBC  cholinesterase activity at the
45 and 150 mg/kg/day dose levels.   Females in the 4.5 mg/kg/day
dose group exhibited depression in RBC cholinesterase activity
at 52 weeks (83% of control values) and 78 weeks (70% of control
values), which was not statistically  significant.  Because of
the apparent dose related decrease in RBC cholinesterase activity
in females in the 4.5 mg/kg/day dose  group, the NOEL for this
effect in females is considered to be below 4.5 mg/kg/day, the
lowest dose tested.

              RBC cholinesterase activity was nominally decreased
in males at the mid and high dose groups.  These effects were
not statistically significant.

              Brain cholinesterase activity was no different from
control values at any dose level in males or females.

              Oncogenicity Data

              The available data are  not adequate  to assess  the
oncogenic potential of ethephon.

              Rat:

              Oncogenic effects were  equivocal  in  this  part  of
the combined chronic/onco study.  Feed containing  ethephon at
levels of 0, 1.5, 15, and 150  mg/kg/day was administered  to  55

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Sprague Dawley rats per  sex  per group.  Slight increases which
were not statistically significant, occurred in pancreatic islet
cell adenomas and carcinomas in the 150 mg/kg/day dose group.   No
statistically significant oncogenic effect was demonstrated during
the study or at termination.   Depression of plasma and red blood
cell cholinesterase activity were  the only observed effects.
Adequate historical control  data must be submitted on pancreatic
islet cell adenomas and  carcinomas.

              The study  is  supplementary because data were not
submitted on the stability  of ethephon  in the feed, and historical
control data were not submitted on the  incidence of pancreatic
islet cell adenomas and  carcinomas.  This study may be upgraded
if these data are submitted  and found to be acceptable.  The
highest dose tested (HDT) of 150mg/kg/day is considered to be
the maximum tolerated dose  (MTD) based  on decreased red blood
cell and plasma cholinesterase activity in males and females.

              Mouse:

              In a supplementary oncogenicity study, Swiss Albino
mice, 85 per sex per group  were fed diets containing 0, 4.5,  45,
and 150 mg/kg/day of ethephon for  78 weeks.  No stability data on
ethephon in the feed were  submitted.  There was a  statistically
significant increased trend in fibrosarcomas in the females,  but
none of the values were statistically significantly different
from controls.  The incidence of hemopoietic carcinogenicity
(leukemia, lymphocytic leukemia, thymic and nonthymic  lymphoma,
and reticulum cell sarcoma)  was statistically significantly
elevated only for females  in the mid dose group.   Historical
control data were not submitted with  this study and are needed
to evaluate the potential  oncogenicity  of this compound.   No
consistent dose related  changes occurred in body weight,  food
consumption, hematology, or organ  weights.

              Using inhibition of  plasma and RBC cholinesterase
as the criteria for determining whether an  MTD was reached  in
this study, the MTD was reached  for  females because statisically
significant inhibition of  plasma and  RBC cholinesterase was
observed.  In males, however, the  finding of  statisically significant
inhibition of plasma cholinesterase and 21% inhibition of RBC
cholinesterase indicated that probably  1/2  MTD was reached.

              The  study is supplementary because data  were not
submitted on the stability of ethephon  in  the  feed and historical
control data on fibrosarcomas were not  submitted.   This study
may be upgraded if acceptable data are submitted.

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                                10


          6.  Teratology and  Reproductive Effects


              Teratpqenic and Fetotoxic Effects

              Sufficient data are available on the teratogenic
potential of ethephon in the  rat and  the rabbit to meet these
data requirements.

              Rat:

              Ethephon was administered to rats by gavage at
doses of 0, 200, 600, and 1800 mg/kg/day from day 6 through day
19 of gestation.  Maternal toxicity occurred in the form of
maternal death at the 1800 mg/kg/day  dose level.

              Fetal resorption was observed at the 1800 mg/kg/day
dose level.  However, this apparent effect (resorption) is equivocal,
because of the small number of litters  remaining for examination
(9 of a possible 25 litters).  The NOEL for maternal and embryo/fetal
toxicity is 600 mg/kg/day. The NOEL  for teratogenic effects is
600 mg/kg/day based on the dose related effects that were observed
at the HOT.  Because of maternal mortality at the HOT, there were
not enough litters remaining  to be statistically significant,
however three of the remaining fetuses  were deformed.  Therefore
the NOEL has been established at the  level tested where no effects
were demonstrated.

              Rabbit;

              Ethephon was administered to rabbits at doses of 0,
50, 100, 250 mg/kg/day by gavage from day 6 through 19 of gestation.
Fetal resorptions were increased only in the 100 and 250 mg/kg/day
dose groups, but they were statistically significant only at the
250 mg/kg/day dose level.  Doses of 250 mg/kg/day resulted in
depression of maternal cholinesterase levels, atoxia and an
increased incidence of various clinical findings, and gross
pathology in the gut.  No effects were  demonstrated in the 50
mg/kg/day dose group, which is designated as the NOEL.

              Reproductive Effects:

              Available data  on the reproductive effects testing
of the technical grade of ethephon are  not acceptable.  Another
study is required.

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                                11

              The available study is classified as core sup-
 plementary because of the following deficiencies: 1) Data on
 individual animals were not reported.  2)  Data  from necropsies
 and  histological examination were not reported. 3) Animal weights
 and  food consumption were not reported with  sufficient frequency
 to determine what if any effects occurred. 4)  Clinical observations
 were not reported. 5) No measures of data variability were
 reported. 6) Biased methods may have been used  in selecting
 pups for further study. 7)  The method used in  breeding and
 calculating indexes were ambiguous. 8) The test substance
 appears to be a formulated  product of unspecified composition.
 9) Dxets were prepared weekly, but no data were submitted on
 the  stability of ethephon in the feed.

          7.  Mutaqenicity  Data

              a.  Gene Mutation -

                  Sufficient data are available on the gene
 mutation potential of the technical grade of ethephon to
 demonstrate that the test substance is not mutagenic in the
 Ames Test.

                  Five strains of Salmonella typhimurium were
 tested up to the toxic concentration/limit dose of 100 ug/100
 uL(10,000 ug/mL) with and without activation.   No evidence of
 mutagenicity occurred.

              b.  Structural Chromosomal  Aberrations -

                  Insufficient data are available from structural
 chromosomal aberration tests, because the identity of the test
 material was insufficiently characterized.   Unless the identity,
 purity, and composition of  the test material is submitted, another
 test is required.

                  Ethephon  of unspecified purity was tested  in
 the  micronucleus test (indirect test for  chromosomal aberrations)
 at toxic dose levels (200 mg/kg) in the mouse system.  NO evidence
 of mutagenicity occurred.  In order for the  study to be acceptable,
 the  test material  must be adequately identified.

              c.  Other Genotoxic Effects -

                  No acceptable data are  available on other
 genotoxic effects.  A gene  mutation study in mammalian cells
 is required.

          8.  Metabolism

              There are no  available metabolism data.  A  rat
metabolism study is required.

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                                12
          9.  Information on Human Effects

              Two studies were conducted on ethephon in humans.
The Agency does not condone nor require human testing.  These
studies were available however, and the Agency considered all
available data in its assessment of the effects of this pesticide.

              In the first study, humans demonstrated some symptoms
characteristic of anticholinesterase activity in a study of five
humans per sex dosed with ethephon at an average dose level of
1.8 mg/kg/day.  Subjects receiving the test compound reported the
following symptoms and/or signs; the sudden onset of diarrhea or
an urgency of bowel movements, stomach cramps or gas, an increased
urgency and frequency of urination, and either a decrease or an
increase in appetite.  None of the control subjects had complaints
similar to the test group.  Plasma CHE and RBC CHE activities
were similar to or higher than initial values in test subjects.

              In the second human study, 10 humans per sex were
dosed with ethephon at 0.5 mg/kg/day for 16 days, followed by a
recovery period of 2 weeks.  Dose related effects occurred in
plasma cholinesterase activity, but not in red blood cell
cholinesterase activity.  The effect was reversible within
15 days.  When the control group and test groups were compared,
the decreased plasma cholinesterase activity was statistically
significant.  No dose related effects were seen in hematology,
blood chemistry, or urine analyses.

              It is not clear whether or not any of the symptoms
in the first human study described, such as diarrhea, urgency of
bowel movements, urinary urgency, or any other effects occurred
in the humans during the dosing period of the second study, since
symptoms and signs were not reported.  Based on this study the
NOEL for plasma cholinesterase inhibition in humans is <.5 mg/
kg/day.


      B.  Human Exposure Hazard

          1.  Pesticide Incident Monitoring System (PIMS):

              Ethephon usage has resulted in four cases of skin
injury (irritation) reported from 1980 through 1986 in California,
due to exposure to field residue.  There were no physician-treated
poisonings from 1980 through 1986 in California.  There were no
deaths reported in the U.S. (1961, 1969, 1973, 1974) and no
deaths reported in California from 1965 to 1977 or from 1982 to
1986.

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                               13


          2.   Protective Clothing

              Technical grade ethephon is corrosive to the skin.
A few cases of skin injury to field workers in California have
been reported (see above PIMS information).  Since ethephon has
been found to be corrosive to the eyes and skin, protective
clothing for  mixers, loaders and applicators is required.  Mixers,
loaders and applicators must wear a full face shield, long trousers,
long sleeved  shirt, gloves, and boots to avoid as much skin and
eye contact as possible.


          3.   Reentry

              Reentry data are required by S 158.390 if the pesticic
and its use patterns meet certain toxicity and exposure criteria.
Ethephon meets the toxicity criteria of 40 CFR S 158.390 because
it is classified as being extremely irritating to the skin
(toxicity category I) and the Agency has received epidemiological
evidence that residues of this pesticide can cause dermal irritation
to persons entering treated sites.  Ethephon also meets the
exposure criteria of 40 CFR S 158.390 in that it is registered
for use on grapes and other crops which have human tasks that
could involve substantial exposure to the pesticide treated
surfaces.  Foliar and soil dislogeable residue data are required
to estimate human exposure resulting from contact with treated
foliage or soil.

              Human exposure monitoring data may be submitted, but
the data submitted should be limited to (1) foliar dislogeable
residues where exposure to treated leaves would be likely and
(2) edaphic dislogeable residues where there could be exposure
to treated soils.

              These data will be used to establish reentry
intervals.  Until these data are available, the the Agency is
imposing interim reentry intervals of 24 hours  for ethephon
treated crops.


          4.   Possible Presence of Impurities

              Available data indicate that  technical ethephon
products may contain 2-chloroethanol as an  impurity.  2-Chloroethano
is extremely toxic via the inhalation route and has  caused human
deaths.  Because of  its volatility, 2-choroethanol is unlikely
to be present in ethephon end use products  in amounts high enough
to pose an inhalation  hazard.  However, the impurity could pose
a hazard when technical or manufacuring use products are  stored
or used in poorly  ventilated spaces.  Under these  conditions,

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                                14


2-chloroethanol vapors could accumulate to levels which may be
hazardous to workers in the area.  The Agency is requiring submissio
of product chemistry data to assess the extent of hazard posed
by 2-choroethanol.

              The Agency has also determined that another impurity,
the mono-chloroethyl ester of (2-chloroethyl)-phosphonic acid,
may be present in technical ethephon products.  This substance
degrades to form 2-choroacetic acid which is a metabolic inhibitor.
Because of the toxicological significance of 2-chloroacetic
acid, the Agency is requiring the submission of residue chemistry
data to determine whether ethephon-treated commodities contain
2-chloroacetic acid residues.


      C.  Tolerance Reassessment


          1.  Tolerances issued

          Tolerances have been established for the residues of
ethephon on various crops under 40 CFR 180.300, 40 CFR 185.2700 and
and 40 CFR 186.2700.  The following is a list of the established
tolerances for ethephon.  There are no CODEX maximum residue
levels (MRL) for ethephon.

                Commodity              Tolerance (ppm)

                Grapes                       2.0
                Hogs, fat                    0.1
                Hogs, mbyp                   0.1
                Hogs, meat                   0.1
                Horses, fat                  0.1
                Horses, mbyp                 0.1
                Horses, meat                 0.1
                Lemons                       2
                Macadamia nuts               0.5
                Milk                         0.1
                Peppers                     30
                Pineapples                   2
                Pineapple fodder             3
                Pineapple forage             3
                Pumpkins                     0.1
                Sheep, fat                   0.1
                Sheep, mbyp                  0.1
                Sheep, meat                  0.1
                Tangerines                   0.5
                Tangerine hybrids            0.5
                Tomatoes                     2
                Walnuts                      0.5

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                                15
                Commodity

                Wheat, grain
                Wheat, straw
                Guavas
                Sugarcane Hawaii only
Tolerance (ppm)

      2.0
     10.0
      0.1
      0.1
           40 CFR 185.2700 and 185.2700 (food and feed additive)

                Barley milling fractions
                  except flour               5.0
                Wheat milling fractions
                  except flour               5.0

                Raisins                     12.0

                Raisin waste                65.0

                Sugarcane molasses           1.5

                Barley milling fractions
                  except flour               5.0

                Wheat milling fractions
                  except flour               5.0
          2.  Residue Data

              a. Metabolism

                 The nature of residues in plants is adequately
understood.  Ethephon degrades to ethylene, phosphate, and chloride.
The parent compound, ethephon and the ethylene gas it produces
are the major metabolites in plants.  Plant metabolism data are
not required.  Acceptable metabolism data are also available for
ruminants.  The residue of concern in plant commodities, ruminant
tissues and milk is ethephon per se. Additional data are required
regarding metabolism in poultry tissues and eggs.

              Upon receipt of the requested data on poultry
metabolism, storage stability data, and data regarding the
magnitude of the crop residues, the adequacy of the established
tolerances for residues of ethephon in animal feed commodities
will be assessed.

             b.  Possible Presence of Contaminant of Toxicoloqical
                 Concern

                 The Agency finds that residues of monochloroacetic
acid may be found in ethephon-treated commodities.  Monochloro-

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                                16

acetic acid is a potential degradation product  of  an  impurity in
ethephon, monochloroethyl ester of (2-chloroethyl )-phosphonic
acid.  Monochloroacetic acid is an extremely toxic metabolic
inhibitor and has been prohibited from addition to food under 21
CFR 189.155.  Analysis of certain food and  feed crops for  residues
of this contaminant are reguiTed as specified  in Appendix  I. A.
If residues of monochloroacetic acid are detected, data may be
required for all eth-ephon-treated commodities.

             c.  Analytical Methodology

                 Adequate gas-liquid chromatographic  (GLC) methods
are available for collection of data pertaining to residues of
ethephon in or on plant and animal commodities.  The  Amchem-plant
method is the recommended method for enforcement purposes  for
plant commodities other than wheat and barley  straw.   This
method has been subjected to a successful method trial for
pineapples and appears as Method I in PAM,  Vol. II.   The Amchem
-cereal method is recommended for enforcement  purposes for
wheat and barley straw.  This method has undergone a  successful
method trial for wheat and barley and has been  forwarded to FDA
for inclusion in the PAM, Vol. II as Method II.  The  Amchem
-tobacco method, the Amchem-sugarcane method,  the AMchem-cotton
method, and the Amchem-citrus oil method are adequate for  data
collection.

                 The nature of the residue  in  poultry has  not
been adequately described.  Therefore, the  adequacy of available
analytical methods for poultry products cannot  be ascertained.

                 The Union Carbide-animal GLC  method  employing a
flame-photometric detector, is the recommended  method for  enforcement
purposes for milk and animal tissue.  This  method has undergone
a successful method trial on milk and liver and has been forwarded
to FDA for inclusion in the "PAM, Vol. II as Method III.  The
Amch^m-tissue GLC method using a phosphorous-specific alkali
thermionic detector (ATD) is adequate for collection  of data
pertaining to residues in cattle and poultry tissues. The Union
Carbide method is adequate for collection of data pertaining  to
residues in milk, meat and meat by-products but not  in fat and
liver.  The Amchem-milk and tissue GLC/ATD  method is  inadequate
for collection of data pertaining to animal tissues  and milk
because recovery is unacceptably low.

                 Ethephon has not been analyzed by multiresidue
methods published in PAM Vol. I, Appendix II-Multiresidue  Method
Testing as required in 40 CFR 15fi.125(b)(15).   In addition,
representative plant samples, ruminant tissues and milk bearing
residues of ethephon must be subjected to analysis by PAM  Vol.  I
methods 211.1, 212.1, 231.1, 232.1 and 252.  Protocols for
multiresidue mehtods are available from the National  Technical
Information Service under Order No. PB 203734/AS.

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                                17

                 The usefulness of  existing residue data for
poultry will be reassessed when the required poultry metabolism
data have been evaluated.   Also methods to be used for future
data collection and enforcement will  be determined after evalua-
tion of the required analytical method validation data.

              d.   Residue Storage Stability

                 Residue storage stability data are available
for sugarcane but not for other plant and animal commodities.

              e-   Field Residue Data

                  The available data  support the established
tolerances for residues of ethephon in or on pumpkins, sugarcane
and sugarcane molasses, provided satisfactory storage  stability
are submitted.  In addition,  a  PHI  of 2 2 months must  be implemented
for sugarcane.

                  Additional  residue  data are required to support
the established tolerances for  residues in or on "blackberries,
coffee beans, cottonseed,  cranberries, grapes, guavas, lemons,
melons, pineapples, pineapple forage, tangerines, tomatoes,
wheat grain and wheat straw.

                  The residue data  requested on wheat  grain, wheat
straw, and the processed fractions of wheat will be used to
asse&s the established tolerances for residues in or on barley
grain, barley straw, and the  processed fractions of barley.
These wheat data  can be used  to support the tolerances for barley
because of the similarity of  the crops.

                  A tolerance must be proposed for residues of
ethephon in or on the agricultural  commodity sugarcane forage.
Alternatively, a  grazing restriction  may be proposed.

              f.   Processing  Data

                  Processing  studies are needed on apples, citrus
fruits, coffee beans, figs, pineapples, sugarcane, tomatoes and
wheat grain.

                  Food/feed additive tolerances and supporting
data are needed for residues  in cottonseed meal, cottonseed
refined oil, cottonseed soapstock,  grape juice, dried  grape
pomace and raisins.

                  Pyrolysis  products derived  from ethephon  must
be characterized  and the level  if residue  in  tobacco  smoke  must
be quantified.

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                              18

             g. Pre-ha^vest Intervals

                Pre-harvest intervals  (PHI) that are based upon
actual field residue data reflecting the maximum proposed use
rates are needed for applications of ethepon  to apples, barley,
blackberries, blueberries,  cherries, coffee beans, cotton, cranber-
ries, cucumbers, figs, filberts,  grapes, guavas, melons, peppers,
pineapples, tangerines, tomatoes, walnuts and wheat.  In the
interim, the PHI's listed in section D of this document must be
placed on end-use product labeling for each crop.

             h. Other findings

                An English  translation of product labels showing
the use directions for the use of ethephon on coffee beans for
importation to the U.S. are required.

                  The entry "pineapple fodder" must be deleted
from 40 CFR 180.300 because pineapple  fodder  is considered a
processed feed not a raw agricultural  commodity.

                  The tolerance for residues  in or on guava
published in FR 45 (136):47147, must be added to the entries
under 40 CFR 180.300 in order to provide a complete listing of
residue tolerances under the appropriate CFR  heading.  Similarly,
a food additive regulation  for ethephon residues in raisins must
be added to 21 CFR 193.186  in order to provide a complete
listing of food additive tolerances under the appropriate CFR
heading.  CFR 180.300 currently designates "N" (negligible)
for certain crop tolerance entries. The concept of negligible
residues is no longer accepted by the  Agency.

              3.  Dietary Assessment

              The toxicology data considered  to  establish a
provisional acceptable daily intake (PADI) include  the following:

a.  A 16-day study in humans where a decrease in plasma chollnesterase
activity was observed at 0.5 mg/kg/day.

b.  A 2-year feeding study in dogs (supplementary)  that demonstrated
a NOEL for reduced body weight of 7.5  mg/kg/
day.

c.  A 2-year feeding study  in rats (supplementary)  that demonstrated
an NOEL for cholinesterase activity at 300 mg/kg/day.

d.  Two teratogenicity studies, one in rats  and  one in  rabbits.
The rat NOEL was established at 600 mg/kg/day and  the  rabbit
NOEL at 50 mg/kg/day.

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                               19


              The PADI  for  ethephon has recently been revised by
the Agency ADI Committee and  is now established at 0.005 mg/kg/day
(0.5 mg/kg/day for a LEL, and an uncertainty factor of 100).
This value is based on  an LEL of 0.5 mg/kg/day for a decrease in
plasma cholinesterase activity  in a 16-day study in humans.  An
uncertainty factor of 100 is derived from a factor of 10 for the
variation in the susceptibility of humans, and a factor of 10
for the use of an LEL instead of a NOEL.  The PADI will be reevaluated
when the toxicity and residue chemistry data required by this
document, as listed in  table  A, are received and evaluated.

              Utilizing the published  tolerances, the Tolerance
Assessment System (TAS) routine analysis yielded a theoretical
maximum residue contribution  (TMRC) value for the U.S. population
that was 284 percent of the PADI when  calculated using 100 percent
of registered crops treated.  After adjustment for percent of
crop treated and an anticipated residue value of 0.01 ppm for
milk, the calculated dietary  exposure  to ethephon for the U.S.
population dropped to 40 percent of the PADI.  For nonnursing
infants and for children 1-6  years of  age, the adjusted values
were 122 and 95 percent of  the  PADI, respectively.

      D•  Environmental Fate

          Available data are  insufficient to fully assess  the
environmental fate of ethephon.

          The only partially  acceptable data available were  two
leaching studies which  provided conflicting  results  regarding
the leaching rates (in  one  study ethephon is a leacher and the
other study demonstrates that ethephon is not a  leacher).  In
one of these studies, ethephon  was  found to be of low  to moderate
mobility in soils ranging in  texture  from loamy  sand,  peat and
silt loam based on soil thin  layer chroma tog raphy  (TLC)  tests.
Therefore, the potential for  contamination of ground water appears
to be low to moderate.   Data  are required on leaching,  volatility,
and hydrolysis of ethephon  to characterize  the  potential  to  reach
ground water.


      E.  Hazard Assessment For Terrestrial  and  Aquatic  Organisms

          1. Aquatic Organisms

          Available acute toxicity  data  indicate that ethephon
is slightly toxic to all fish  species tested.   The Guidelines
requirements for freshwater fish acute LC$Q  data with technical
ethephon have been met.  The LC$Q for freshwater fish results
from two 96-hour studies using  the technical grade material  and
the LC   values follow:

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                             20
          Species             !_§_i       LC^n mq/L
          Bluegill            21.6           67
          Bluegill            21.5        >  180
          Bluegill            71.3          221.7
          Bluegill            92            106

          Rainbow Trout       21.6           77
          Rainbow Trout       71.3          254.5
          Rainbow Trout       92          >  110

          Ethephon is practically non-toxic  to aquatic inver-
tebrates (daphnids) with an LC$Q value of  >  180 mg/L.  Technical
ethephon is slightly toxic  on an acute basis to  grass shrimp
with an LCsg of 160 to >370 mg/L and  mud crabs with an LCso
of 167 to >370 mg/L.  There are no data available  to characterize
the toxicity of ethephon to either estuarine/ marine fish or
mollusks.  Because the LC$Q values of freshwater  (93 to  165
mg/L) and saltwater (160 to >370) invertebrates indicate similar
toxicities for fresh and saltwater classes of animals, and because
of low toxicity to freshwater fish, the Agency will waive the
requirement for estuarine/marine fish testing.  However/  the
Guidelines requirements for testing mollusks are  not satisfied,
and are required.


          2. Terrestrial Organisms

             There is no evidence to  suggest that  the use of
ethephon has resulted in avian or mammalian  mortality or has
affected their population levels.

             The data indicate that technical ethephon is slightly
toxic on an acute oral basis to bobwhite quail, and on a subacute
dietary basis is sightly toxic to bobwhite quail  and mallard
ducks.  The acute oral LCsg in bobwhite quail is  from 596 to
804 mg/kg.   The acute oral  LCso is 3750 ppm  for mallard  duck
and >2160 ppm in bobwhite quail.  The average acute oral toxicity
for formulated products is >10,000 ppm in  bobwhite quail, or
practically non-toxic.

              No avian reproduction study  was available  for
evaluation; the study is not being required  at  this  time because
the use patterns are not anticipated  to subject birds to repeated
exposure during the breeding season.

              There is sufficient information to  characterize
ethephon as relatively nontoxic to honeybees.

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                                21


          3.  Plant Protection

              No plant protection  studies were available for
evaluation: All Tier I data  on Non-Target Area Phytotoxicity are
required for pesticides used in forests and natural grasslands.
In addition, Aquatic Plant Growth  data are required as special
testing (Section 70-1) for the cranberry use because that use
involves application of ethephon in  close proximity to aquatic
habitats.  Thus, Tier I testing is required to assess the potential
hazard to both terrestrial and aquatic nontarget plants.

      F.  Endangered Species

          No precautionary labeling  is required at this time.
However, the Agency does not have  adequate environmental fate
data to judge the potential  risk to  nontarget plant species.
The Agency will reassess the risk  to nontarget plant species
when the environmental fate data required by this document
(listed in table A) are submitted  and have been evaluated.

      G.  Product Chemistry Evaluation

          Although product chemistry data may have been submitted
in the past, the Agency has determined that these data must be

resubmitted for each pesticide.  New requirements have been
introduced and previously submitted  data must be updated.  As
discussed above, the Agency has identified impurities which may
be present in in ethephon and is requiring data to ascertain the
extent of contamination.
IV.   REGULATORY POSITION

      A.  Regulatory Positions and Rationales

          Based on review and evaluation of all  available  data
and other relevant information on ethephon, the  Agency  has made
the following determinations:

          1.  A Special Review is not being initiated at this
time.

              Rationale;

              If a pesticide meets or exceeds any of  the criteria
specified in 40 CFR 154.7, a Special Review of the chemical  may
be conducted.  Agency review and evaluation of the available data
indicate that none of the criteria specified have been  met or
exceeded by the currently registered use patterns for  ethephon.

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                                22

          2.  The Agency will not require restricted  use
classification for ethephon end-use products.


              Rationale;

              Although ethephon meets one of  the criteria for
restricted use classification because of its  corrosivity  to the
eyes and skin, label restrictions requiring protective clothing
will be adequate to address the hazard without imposition of
the restricted use classification.  See section IV  B  of this
document for the required label statements.

          3.  The Agency is deferring decisions concerning ethephon1s
potential for contaminating ground water until information on
its environmental characteristics and fate have been  submitted
a nd r ev i ew ed.

              Rationale;

              The Agency is unable to assess  the potential for
ethephon to contaminate ground water because  the environmental
fate of this chemical is largely unknown.   Preliminary data
indicate that unaged ethephon may be mobile in loamy  sand, silt
loam and peat soils, and immobile in sandy clay loam  soils.
Additional data are needed in order to assess the  environmental
fate of ethephon.  When these data have been  received and evaluated,
the Agency will assess ethephon1 s potential  for ground water
contamination and will determine whether any  regulatory action is
necessary.

          4.  The Agency has identified certain data  that will
receive immediate review when submitted.

              Rationale;

              Certain data are essential to  the Agency's
assessment of this pesticide and its uses and/or may  trigger
the need for further studies which should be  initiated as
soon as possible.  The following studies have been  identified
to receive priority review as soon as they are received by the
Agency:

Residue Chemistry:  158.240

   Metabolism (animal)                 171-4

Toxicology:          158.340

   21-day Dermal                         82-2

   21-day Smoke Inhalation              82-X

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                                23


    General Metabolism                   85-1

    Chronic Toxicity Rodent              83-1*

    Oncogenicity data                    83-2*

 Environmental Fate  158.290

    Leaching Adsorption/Desorption      163-1

    Vegetative Vigor                    122-1

    Seedling Germination and
    Seedling Emergence                  122-1

    Aquatic Plant Growth                122-1

    *These studies may be upgraded or they will  have  to be  repeated

          5.  The Agency has determined that  foliar and soil
 dislogeable residue data are required to establish  reentry
 intervals for all crops.  An interim reentry  interval of  24
 hours is being imposed for all crops until final  reentry
 reentry intervals are established.

              Rationale:

              An interim 24-hour reentry interval is  being  imposed
 for the agricultural uses of ethephon until adequate  data have
 been submitted and evaluated.  Interim reentry  intervals  are
 being imposed to provide worker protection while data needed  to
 establish reentry intervals are being generated.


          6.  Pre-harvest intervals are required  on product
 labeling for a variety of currently registered  use  sites.


              Rationale:

              The ethephon product labels do  not  specify  pre-
 harvest intervals (PHIs) for many crops, but  include  recommended
 treatment-to-harvest intervals based on efficacy  rather than
on  residue data.  In addition, data indicate  that residues  in or
on  some of the commodities increase over time then  decline.
Therefore, a PHI must be proposed based on the residue data  for
the following crops:

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                                24


Peppers, cucumbers, melons,  tangerines, apples, cherries, Black-
berries/boysenberries, cranberries,  grapes, filberts, walnuts,
barley, wheat, wheat forage,  hay and straw, coffee beans,
Cottonseed, figs, guavas,  pineapples, and  sugarcane.

              Interim PHI's  based on the  existing data are
required on end-use product  labels  (refer  to  section D of this
document).

           7.   The Agency  is requiring data on animal metabolism
as well as storage stability studies and  residue  studies for
poultry and eggs.  In order  to  remain in compliance with FIFRA,
registrants must do one of the  following:

              a.  Submit data which  demonstrate that no residues
remain in eggs and poultry as a result of  feeding treated
commodities;

              b.  Propose  tolerances and provide appropriate
supporting data for residues in poultry tissues and eggs.

              Rationale;

              Ethephon residues may  be found  in agricultural
commodities used for poultry feed.   If residue-bearing com-
modities are fed to poultry,  residues may  be  present in poultry
and eggs (which may be used  for human food).  However, no tolerance
exist for these foods.  In order to  avoid  unauthorized levels of
ethephon residues, it must be demonstrated that residues will
not be found in poultry and  eggs, or tolerances must be  established.

          8.  Additional residue data, including  processing data,
must be submitted for the  following  raw agricultural commodities:
peppers, tomatoes, cucumbers, melons, lemons, tangerines, apples,
cherries, blackberries, boysenberries, blueberries, cranberries,
grapes, filberts, walnuts, barley (wheat  data may substitute),
wheat, (and wheat straw),  coffee beans, cotton  seed, figs, guavas,
pineapples, sugarcane, and tobacco.   For  tobacco, pyrolysis data
must be submitted.  If residues concentrate in any of  the processed
products, the appropriate  food  additive tolerance(s) must be
proposed.  Specific data requirements may  be  found  in  the data
tables.

              Rationale:

              The available  data are inadequate to  support
existing tolerances for these commodities.

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                                25

          9.   The Agency  is  requiring the proposal of either a
tolerance for sugarcane forage or a grazing prohbition for sugarcane
forage.

              Rationale;

              Since forage is a  raw agricultural commodity of
sugarcane, a  tolerance must  be establish for it.  However, no
tolerance exists.   Residue data  are needed to establish a tolerance
and a pregrazing interval.

         10.   The Agency  has determined that the following revisions
in the tolerances listed  in  40 CFR 180.300 and 21 CFR 193.186 are
necessary.

              o  The designation "N" (negligible) must be deleted
                 from all tolerances entries.

              o  The commodity "pineapple fodder" must be deleted
                 from 40  CFR 180.300.

              o  The tolerance for guava must be added to 40 CFR
                 180.300.

              o  The tolerance for raisins must be added to 21
                 CFR 193.186.
              Rationale:

              0   The Agency  no  longer accepts the concept of
                 "negligible"  residues,  therefore the designation
                 will no  longer be  used.

              0   The tolerance  for  residues  in or on pineapple
                 fodder  is inappropriate because this commodity
                 is not  a raw agricultural commodity but a proces-
                 sed animal  feed  item.

              0   The tolerance  for  guava should be published
                 under 40 CFR  180.300.   Although a tolerance was
                 published in  the 1980  (45 FR 47147), the listing
                 of this tolerance  does not  appear in the Code of
                 Federal  Regulations.   Correction of this omission
                 will make the  CFR  current for ethephon.

              0   A food  additive  tolerance for raisins was estab-
                 lished  in 21  CFR 193.186 but does not appear in
                 current issues of  the  Code  of Federal Regulations.
                 A correction  would make the CFR current for
                 ethephon.

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                                26

         11.  Product chemistry and  residue data are required
depicting residues of monochloroac etic  acid in or on food and
feed commidities following registered applications of ethephon.

              Rationale:

              Monochloroac etic acid  is  a  potential degradate
of certain impurities in the ethephon  technical product.  Because
of its extreme toxicity, it is currently  regulated under 21 CFR
189.155 ("Food containing any added  or  detectable level of
monochloroac tic acid is deemed to be adulterated...").  Therefore,
the Agency deems it necessary to determine whether monochloroac etic
acid is likely to occur in food as a result of direct treatment
with ethephon.


         12.  The Agency has identified 2-chloroethanol as a
contaminant of toxiclogical concern.  The Agency is requiring
data to assess the extent of contamination with this substance.
Additionally,  the Agency is requiring  that manufacturing use
products bear a label statement advising  users to store and use
the product in well-ventilated areas.   The label statement appears
in Section D. 3.  of this document.

              Rationale:

              2-Chloroethanol has been  found  in technical ethephon
products.   This substance is extremely  toxic  through the inhalation
route.  More data are required to assess  the  extent of contamination
with 2-chloroethanol.  The impurity  could pose a hazard when
technical  or manufacturing use products are stored or used
under conditions that permit 2-chloroethanol  vapors to accumulate
to hazardous levels.  Storage or use of technical or manufacturing
use ethephon products in wellventilated areas would reduce
the risk of posed by 2-choroethanol.  Accordingly, the Agency
is that the labels of manufacturing  use products be revised to
state that the product should be stored and used in well-ventilated
a r ea s.


         13.  While the data gaps are being filled, currently
registered manufacturing-use products  and end-use products
containing ethephon as the sole active ingredient may be sold,
distributed, formulated, and used in the  United States, subject
to the terms and  conditions specified  in  this Standard.
Registrants must  provide or agree to develop  additional data,
as specified in Appendix I to maintain  existing registrations.

              The Agency will issue  registrations  for
substantially similar products and new  uses will be issued
after considering the effects on the theoretical maximum residue
contribution (TMRC) and the maximum  permissable intake  (MPI).

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                                27

              Rationale:

              Section 6 of FIFRA authorizes the Administrator
to cancel a pesticide registration  if  he determines that the
pesticide will cause unreasonable adverse  effects on the
environment.  Based on available data,  the Administrator has not
made such a determination as to  ethephon.  The Administrator has
authority under FIFRA sections 3(c)(2)(B)  and 3(c)(7) to require
registrants and applicants for registration to provide data
needed to support new or continuing registrations.

              Issuance of this Standard provides a mechanism for
identifying data needs.  These data will be reviewed and evaluated
and the Agency will determine if the data  will affect the registra-
tion of ethephon.

      B.  Criteria For Registration

          To be registered or reregistered under this Standard,
products must contain ethephon as the  sole active ingredient;
bear required labeling; and conform to  the product composition,
and use pattern requirements listed in  this section.

      C.  Acceptable Ranges and  Limits

          1.  Product Composition Standard

              To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain ethephon as the
sole active ingredient.  Each MP formulation proposed for registratior
or reregistration must be fully described  with an appropriate
certification of limits, stating maximum and minimum amounts of
the active ingredient and inert ingredients which are present  in
products/ as well as impurities found  at greater than 0.1 percent.

          2.  Acute Toxicity

              The Agency will consider  registration of technical
grade and manufacturing-use products containing  ethephon provided
that the product labeling bears appropriate precautionary state-
ments for the acute toxicity category  in which each product  is
placed.

          3.  Use Patterns

              To be registered under this  Standard,  technical
grade or manufacturing-use products containing ethephon may  be
labeled for formulation into end-use products registered only
for the uses listed in the EPA compendium  of acceptable uses.
This compendium lists all registered uses, as well as approved
maximum application rates and frequencies  and is available  through
the preedom of Information Office.

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                                28

      D.  Required Labeling

          In order to remain in compliance with FIFRA, products
must bear appropriate labeling as specified in 40 CFR 156.10
and in this Standard, or must be revised to conform to those
specifications.  Appendix II contains information on labeling
requirements.

          No pesticide product containing ethephon may be released
for shipment by the registrant or producer after September 30/ 1989
unless the product bears an amended label which complies with the
requirements of this standard.

          No pesticide product containing ethephon may be
distributed or sold after September 30,  1990 unless the product
bears an amended label which complies with the requirements of
this Standard.

          The following specific information must appear on
the labeling in order for porducts to remain in compliance
with FIFRA:

          1.  Ingredients Statement

              The ingredient statement shall list the active
ingredient as:

              ACTIVE INGREDIENT:

Ethephon [(2-chloroethyl) phosphonic acid]:     	 %

          2.  Use Pattern Statement

              All manufacturing-use products must state that
they are intended for formulation into end-use products for
acceptable use patterns.  Labeling must  specify sites, which are
listed in Use Patterns, section C.3.  However, no use may be
included on the label where the registrant fails to agree to comply
with data requirements in Table A for that use pattern.

          3.  The Following Must Appear  on MUP Labels

               "Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
unless this product is specifically identified and addressed in a
NPDES permit.   Do not discharge effluent containing this product
to sewer systems without previously notifying the sewage treatment
plant authority.  For guidance contact your State Water Board or
Regional Office of the EPA."

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                                29

               "Technical grade ethephon must be stored and used
in ventilated areas only."


          4.  The Following Must Appear on EP Labels

               "Do not apply directly to water or wetlands (swamps,
bogs, marshes, and potholes).  Do not contaminate water when
disposing of equipment washwaters."

               "Mixers, loaders and applicators must wear a full
face shield, long trousers, long sleeved shirt, gloves, and boots
to avoid as much skin and eye contact as possible."

               "Do not enter treated fields within 24 hours
after application unless protective clothing is worn."

                The following interim pre-harvest intervals (PHI)
must be included on end use product labels for the raw agricultural
commodities listed.  These interim PHI's may be revised after the
required field residue data have been submitted and evaluated.

                Apples, minimum 7 days; barley, 40 days;
blackberries and blueberries, 42 days; cherries, minimum 7 days';
coffee beans, 14 days; cotton, 14-21 days; cranberries, 17-21
days; cucumbers, 17-21 days; figs, 14 days; filberts, 7 days;
grapes, 14 days; guavas, 7 months; melons, 2 days; peppers, 14
days; pineapples, 2 days; tangerines, 5-10 days; tomatoes, 14-20
days for processing and 3-6 days for fresh market in California
only; walnuts, 5-10 days; wheat, 40 days.

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                              30

            V.  PRODUCTS SUBJECT  TO  THIS STANDARD

     All products containing one  or  more of the pesticides
identified in Section II.A.  are subject to certain requirements
for data submittal or changes in  composition, labeling or
packaging of the product.   The applicable requirements depend
on whether the product is a  manufacturing or  end use product
and whether the pesticide is the  sole active  ingredient or
one uf multiple active ingredients.

    Products are subject to  this  Registration Standard as
follows:

A.  Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:

     1.  The restrictions (if any) upon use, composition, or
     packaging listed in Section  IV, if they pertain to the
     manufacturing use product.

     2.  The data requirements listed in Tables A and fi2

     3.  The labeling requirements specified  for manufacturing
     use products in Section IV.

     4.  Administrative requirements (application forms, Confiden-
     tial Statement of Formula, data compensation provisions)
     associated with reregistration.
2 Data requirements are listed in the three Tables  in
Appendix I of this Registration standard.   The Guide to
Tables in that Appendix explains how to  read the Tables.

  Table A lists generic data requirements  applicable to all
products containing the pesticide subject  to this Registra-
tion standard.  Table B lists product-specific data applicable
to manufacturing use products.  The data in Tables  A and  B
need not be submitted by an end use producer who is eligible
for the generic data exemption for that  active ingredient.

  Table C lists product-specific data applicable to end use
products.  The Agency has decided that,  in most cases,  it
will not require the submittal of product-specific  data for
end use products at this time.  Therefore  most Registration
Standards do not contain a Table C.

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                              31

B.  Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:

    1.  The data requirements  listed in Table A.

    2.  The labeling requirements  specified for manufacturing
    use products in Section  IV.

C.  ^nd use products containing  this pesticide as the
sole active ingredient are subject to:

     1.  The restrictions (if  any)  upon use, composition, or
     packaging listed in Section IV if they pertain to the
     end use product.

     2.  If eligible for the generic data exemption3, the
     data requirements listed  in Table C.

     3.  If not eligible for the generic data exemption, the
     data requirements listed  in Table A and the data require-
     ments listed in Table C.

     4.  The labeling requirements specified for end use
     products in Section IV.

D.  End use products containing  this pesticide as one of
multiple active ingredients  are  subject to:

     1.  If not eligible for the generic data exemption,
     the data reauirements listed  in Tables A and C.
3 if you purchase from another  producer and use as the
source of your active ingredient  only  EPA-registered products,
you are eligible for the generic  data  exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered  manufacturing use product
you purchase (Table B).

     Two circumstances nullify  this exemption:

     1)  If you change sources  of active  ingredient to an
unregistered product, formulate your own  active ingredient,
or acquire your active ingredient from a  firm with ownership
in common with yours, you individually lose  the exemption
and become subject to the data  requirements  in Table A.

     2)  If no producer subject to the generic data requirements
in Table A agrees to submit the required  data, all  end use
producers lose the exemption, and become  subject  to the data
reauirements in Table A.

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                              32

     2.  If eligible for the generic data  exemption, the
     data requirements listed in  Table  C.

     3.  The labeling requirements specified for end use
     products in Section IV.
       VI.  REQUIREMENT FOR SUBMISSION OF GENERIC DATA

     This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B).  It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain  in  effect the regis-
tration of products containing this active  ingredient.4

A.  What are generic data?

     Generic data pertain to the properties or effects of a
particular active ingredient.  Such data are  relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that  would make  the data
requirement inapplicable).

     Generic data may also be data on a  "typical formulation"
of a product.  "Typical formulation" testing  is often required
for ecological effects studies and applies  to all products
having that formulation type.  These are classed as generic
data, and are contained in Table A.

B.  Who must submit generic data?

     All current registrants are responsible  for submitting
generic data in response to a data request  under FIFRA  sec.
3(c)(2)(B) (DCI Notice).  EPA has decided,  however, not  to
require a registrant who qualifies for  the  formulator's
exemption (FIFRA sec. 3(c)(2)(D) and S  152.85) to submit
generic data in response to a DCI notice if  the  registrant
who supplies the active ingredient in his product is complying
with the data request.

     If you are granted a generic data  exemption, you rely on
the efforts of other persons to provide the Agency  with  the
required data.  If the registrants who  have committed to
generate and submit the required data  fail  to take  appropriate
steps to meet the requirements or are no longer  in  compliance
with this data requirements notice, the Agency will consider
4 Registrations granted after issuance of this Standard  will
be conditioned upon submittal or citation of the data  listed
in this Registration Standard.

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                              33

that both they and you are not in compliance and will normally
initiate proceedings to suspend the  registrations of both
your product(s) and their  product(s) unless you commit to submit
and submit the required data  in the  specified timeframe.   In
such cases, the Agency generally will not grant a time extension
for submitting the data.

     If you are not now eligible for a generic data exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm.  If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s)  and you  must submit a Generic Data Exemption
Statement.

     If you apply for a new registration for products containing
this active ingredient after  the issuance of this Registration
Standard, you will be required to  submit or cite generic data
relevant to the uses of your  product if, at the time the
application is submitted,  the data have been submitted to the
Agency by current registrants.  If the required data have not
yet been submitted, any new registration will be conditioned
upon the new registrant's submittal  or citation of the
required data not later than  the date upon which current
registrants of similar products are  required to provide  such
data.  See FIFRA sec. 3(c)(7)(A).  If you thereafter fail to
comply with the condition of  that  registration to provide
data, the registration may be cancelled  (FIFRA sec.  6(e)).

C.  *That generic data must be submitted?

     You may determine which  generic data you must  submit by
consulting Table A.  That table lists  the generic data needed
to evaluate current uses of all  products containing  this
active ingredient, the uses for which  such data are  required,
and the dates by which the data must be  submitted  to  the
Agency.

D.  How to comply with PCI requirements.

     Within 90 days of your receipt  of  this  Registration
Standard, you must submit to EPA a completed copy  of the form
entitled "FIFRA Section 3(c)(2)(B) Summary  Sheet"  (EPA Form
8580-1, enclosed) for  each of your products.   On  that  form
you must state which of the following  six  methods  you  will
use to comply with the DCI requirements:

     1.  YOU will submit  the data  yourself.

     2.  You have entered into an agreement  with  one or more
registrants to jointly develop (or share in  the cost of
developing) the data,  but will not be submitting  the data
yourself.  If you use  this method, you must  state who will

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                              34

submit the data on which you will  rely.  You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be:  (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by  the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon  its submittal.
The Agency will also require adequate assurance that the
person whom you state will provide the data  is taking appropriate
steps to secure it.  The agreement to produce the data need
not specify all of the terms of the  final arrangement between
the parties or a mechanism to resolve the terms.

     If you and other registrants  together  are generating or
submitting requested data as a task  force or consortium, a
representative of the group should request  a Joint Data
Submitter Number, as part of your  90-day response.  The
request must include the following information:

     a.  A list of the members of  the consortium;
     b.  The name and address of the designated representative
         of the consortium, with whom EPA will correspond
         concerning the data;
     c.  Identity of the Registration Standard containing
         the data requirement;
     d.  A list of the products affected (from all members
         of the consortium); and
     e.  Identification of the specific data that the con-
         sortium will be generating  or  submitting.

     The Agency will assign a number  to the consortium, which
should be used on all data submittals by the consortium.

     3.  You have attempted to enter into an agreement  to
jointly develop data, but no other registrant has accepted
your offer.  You request that EPA not suspend your registration
for non-compliance with the PCI.   EPA has determined  that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought  and
continues to seek to enter into a  data  development/cost
sharing program, but the other registrants  developing  the
data have refused to accept its offer.   [If your offer  is
accepted, you may qualify for Option 2  above by entering
into an agreement to supply the data.]

     In order to qualify for this method, you must:

     1.  File with EPA a completed "Certification of  Attempt
to Enter into an Agreement with other Registrants for  Develop-
ment of Data" (EPA Form 8580-6, enclosed).

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                             35

     2.  Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt).  Your offer must,
at a minimum,  contain the following language or its equivalent:

     [Your company name] offers to share in the burden of
     producing the data required pursuant to FIFRA sec.
     3(c)(2)(B) in the [name of active ingredient] Registration
     Standard  upon terms to be agreed or failing agreement
     to be bound by binding arbitration as provided by FIFRA
     section 3(c) (2)(B) (iii).

The remainder  of your offer may not in any way attempt to
limit this commitment.  If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI summary sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option.  In order for you to avoid
suspension under this method, you may not later withdraw or
limih your offer to share in  the burden of developing the
data.

     In addition, the other registrant must fulfill its
commitment to  develop and submit the data as required by this
Notice in a timely manner.  If the other registrant fails to
develop the data or for some other reason would be 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 submit the required
data in the specified timeframe.   In such cases,  the  Agency
generally will not grant a  time  extension for  submitting the data.

     4.  YOU request a waiver of the data requirement.  If
you believe that a data requirement does not  (or  should not)
apply to your product or  its  uses, you must provide  EPA with
a statement of the reasons  why you believe  this is  so.  Your
statement must address the  specific composition or  use factors
that lead you to believe that a  requirement does not  apply.
Since the Agency has carefully considered the  composition and
uses of pesticide products  in determining that -a  data require-
ment applies, EPA does not  anticipate  that  many waivers will
be granted.  A request for  waiver  does not  extend the time-
frames for developing required data, and  if  your waiver
request is denied, your registration may be suspended if you
fail to submit the data.   The Agency will  respond in writing
to your request  for a waiver.

     5.  YOU request that EPA amend  your registration by deleting
the uses for which  the data are needed.   You ar-e not required
to submit data for  uses which are no  longer on your label.

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                              36

     6.  You request voluntary cancellation of the registration
of your product(s) for which the  data  are  needed.


E.  Registrant Requests Regarding Data Requirements and Agency
    Responses

     All requests for modification of  data requirements
(inapplicability, waiver),  approval of protocols or protocol
changes, or time extensions must  be submitted in writing.
The original requirement remains  in effect unless the Agency
has notified you in writing that  it has agreed to a change in
the requirement,  while being considered by the Agency, such
requests for changes in the requirements do not alter the
original requirements or extend the time allowed for meeting
the requirement.


F.  Test Protocols and Standards

    All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.  All testing must
be conducted in accordance with applicable Good Laboratory
Practices regulations in 40 CFR Part 160.

    The Pesticide Assessment Guidelines, which are referenced
in the Data Tables, 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 (Part 158.70).
Please note, however, that certain OECD standards  (such as
test duration, selection of test  species,  and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
list<=d above.   When using the OECD protocols, they should be
be modified as appropriate so that the data generated by  the
study will satisfy the requirements of Part 158.  Normally,
the Agency will not extend  deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards.   The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.

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                              37

G.  Procedures for requesting  a change in test protocol.

     If you will  generate  the  required data and plan to use
test procedures which deviate  from EPA's Pesticide Assessment
Guidelines or the Reports  of Expert Groups to the Chemicals
Group, Organization for  Economic  Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.

     You should submit your protocols before beginning testing,
because the Agency will  not ordinarily accept as sufficient
studies using unapproved protocols.  A request for protocol
approval will not extend the timeframe for submittal of the
data, nor will extensions  generally be given to conduct
studies due to submittal of inappropriate protocols.  The
Agency will respond in writing to your request for protocol
approval or change.

H.  Procedures for requesting  extensions of time.

     If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time.

     EPA will view failure to  request an  extension before
the data submittal response deadline as a waiver of any
future claim that there  was insufficient  time  to submit the
data.  While EPA considers your  request,  you must  strive to
meet the deadline for submitting  the data.

     The extension request should state the  reasons why you
believe that an extension  is necessary and the steps you
have taken to meet the testing deadline.  Time extensions
normally will not be granted due  to problems with  laboratory
capacity or adequacy of  funding,  since  the Agency  believes
that with proper planning  these can be overcome.   The  Agency
will respond in writing  to any requests for  extension  of time.


I.  Data Format and Reporting  Requirements

    All data submitted in  response  to  this Notice  must comply
with 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  Notice  86-5 (issued
July 29, 1986).  All  studies must be submitted in  the form of
a final report; a preliminary report  will not be considered
to fulfill the submittal  requirement.

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                              38
J.  Existing stocks provision upon suspension or cancellation.

     The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision for the
registrant is not consistent with the Act.  Accordingly, the
Agency does not anticipate granting permission to sell or
distribute existing stocks of suspended product except in
rare circumstances.  If you believe that your product will be
suspended or cancelled and that an existing stocks provision
should be granted, you have the burden of clearly demonstrating
to EPA that granting such permission would be consistent with
the Act.  The following information must be included in any
request for an existing stocks provision:

     1.  Explanation of 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 or distribution; and

     2.  Demonstration that such a provision would be consis-
     tent with the provisions of FIFRA.
   VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA

     Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect.  Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.

     If you have a manufacturing use product, these data are
listed in Table B.  If you have an end use product, the data
are listed in Table C.  As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time.  Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.

     In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic'data.
See Section VI.D through J.  You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6.(cancellation of registration).

     Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.

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                              39
    VIII.  REQUIREMENT FOR SUBMITTAL OF REVISED LABELING

     FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses.  General labeling requirements are set out in
40 CFR 156.10 (see Appendix II - LABELING and SUMMARY).  In
addition, labeling language specific to products containing
this pesticide is specified in Section IV.D of this Registra-
tion standard.  Responses to this Registration Standard must
include draft labeling for Agency review.

     Labeling must be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files.  Draft labeling must indicate the intended
colors of the final label, clear indication of the front
panel of the label, and the intended type sizes of the text.

     If you fail to submit revised labeling as required,
which complies with 40 CFR 156.10 and the specific instructions
in Section IV.D., EPA may seek to cancel the registration of
your product under FIFRA sec. 6.


               IX.  INSTRUCTIONS FOR SUBMITTAL

     All submittals in response to this Registration Standard
must be sent to the following address:

     Office of Pesticide Programs
     OPP Mailroom  (TS-767C)
     Environmental Protection Agency
     401 M St., SW
     Washington, D.C.  20460

     Attn:  ETHEPHON Registration Standard

     All submittals in response to this Registration standard
are non-fee  items, including  90-day  responses, protocols and
waiver  requests, data, and revised  labeling,   submittals must
be clearly identified as being  in response  to  the  Registration
Standard.  Under no circumstances may Registration standard
responses be  combined with other types  of filings  for  which
fees are required.

A.  Manufacturing  Use Products  (MUPs)  containing  the subject
    pesticide as sole active  ingredient.

    1.   within 90  days  from  receipt  of  this document,  you
must submit  for  each  product  subject to this Registration
Standard:

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                              40

        a.  Generic Data Exemption Statement  (EPA Form 8580-3),
    if applicable, or the "FIFRA Section  3(c)(2)(B) Summary
    Sheet" (EPA Form 8580-1),  with appropriate attachments.

        b.  Confidential Statement of  Formula  (EPA Form 8570-4).

        c.  Evidence of compliance with data compensation
    requirements of FIFRA sec. 3(c)(l)(D).  Refer to 40 CFR
    152.80-152.99.

    2.  Within 9 months from receipt of this document you
must submit:

        a.  Application for Pesticide  Registration (EPA
    Form 8570-1).

        b.  Two copies of any required product-specific data
    (See Table B).

        c.  Three copies of draft labeling, including the
    container label and any associated supplemental labeling.

        d.  Product Specific Data Report  (EPA  Form 8580-4).

     3.  Within the times set forth in Table  A,  you must
submit all generic data, unless you are eligible for the
generic data exemption.  If for any reason any  test is delayed
or aborted so that the schedule cannot be met,  immediately
notify the Agency of the problem, the  reasons  for the problem,
and your proposed course of action.

B.  Manufacturing Use products containing the subject pesticide
    in combination with other active ingredients.

    1.  Within 90 days from receipt of this document, you
must submit:

        a.  Generic Data Exemption Statement  (EPA Form 8580-3),
    if applicable, or the FIFRA sec. 3(c)(2)(B)  Summary
    Sheet, with appropriate attachments  (EPA  Form 8580-1).

        b.  Confidential Statement of  Formula  (EPA Form  8570-4)

    2.  Within 9 months of receipt of  this document, you must
submit:

        Three copies of draft labeling,  including the container
    label and any associated supplemental labeling.

    3.  Within the time frames set forth  in Table A, you must
submit all generic data, unless you are eligible for  the
generic data exemption.  If for any reason  any test  is delayed
or aborted so that the schedule cannot be met,  immediately

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                             41

notify the Agency of  the  problem, the reasons for the problem,
and your proposed course  of action.


C.  End Use Products  containing the subject pesticide as sole
    active ingredient.

    1.  Within 90 days  from receipt of this document, you
must submit:

        a.  Generic data  exemption Statement (EPA Form 8580-3),
    if applicable, o_r the FIFRA Section 3(c)(2)(B) Summary
    Sheet, with appropriate attachments (EPA Form 8580-1).

        b.  Confidential  Statement of Formula (EPA Form 8570-4).

    2.  Within 9 months from  receipt of this document you
must submit:

        a.  Two copies  of any product-specific data, if required
    by Table C.

        b.  Product Specific  Data Report  (EPA Form 8580-4),
    if Table C lists  required product-specific data.

        c.  Three copies  of draft labeling, including the
    container label and any associated supplemental labeling.

    3.  Within the times  set  forth in Table A, you must
submit all generic data,  unless you are eligible  for the
generic data exemption.  If for any reason any test is delayed
or aborted so that the  schedule cannot be met, immediately
notify the Agency of  the  problem,  the reasons for the problem,
and your proposed course  of action.


D.  End Use Products  containing  the subject active  ingredient
    as one of multiple active ingredients

    1.  Within 90 days from  receipt of this document, you
must submit:

        a.  Generic data  exemption  Statement  (EPA Form  8580-3),
    if applicable, or the FIFRA  Section 3(c)(2)(B)  Summary
    Sheet, with appropriate attachments  (EPA  Form 8580-1).

        b.  confidential  Statement of  Formula  (EPA  Form 8570-4).

    2.  Within 9 months from  the receipt  of  this document,  you
must submit:

    Three copies of draft labeling,  including  the container
    label and any associated  supplemental labeling.

-------
                              42

    3.  Within the times set  forth  in Table A, you must
submit all generic data, unless you are  eligible for the
generic data exemption.   If  for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
E.  Intrastate Products

    .applications for full  Federal  registration of intrastate
products were required  to  be submitted  no later than July 31,
1988.   Unless an application for  registration was submitted
by that date, no product may be  released for shipment by the
producer after July 31, 1988.

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                              43

                           TGUIDE-1

                       GUIDE TO TABLES

     Tables A, B, and C contain listings of data requirements
for the pesticides covered  by this Registration Standard.

     Table A contains generic data requirements that apply to
     the pesticide in all  products,  including data requirements
     for which a "typical  formulation"  is  the test substance.

     Table B contains product-specific  data requirements that
     apply only to a manufacturing use  product.

     Table C contains product-specific  data requirements that
     apply only to an end  use product.

     The data tables are generally organized according to 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 out in  the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA  22161.

2.  Test Substance (Column 2). This column lists the composition
of the test substance required to be used  for the test, as
follows:

     TGAI = Technical grade of the active  ingredient
     PAI =  Pure active ingredient
     PAIRA = Pure active ingredient, radio labeled
     TEP =  Typical end use formulation
     MP =   Manufacturing  use product
     EP =   End use product

Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes  to the table.

3.  Use pattern (Column 3).  This column  indicates the use
patterns to which the data requirement  applies.   Use patterns
are the same as those given in 40 CFR Part 158.   The following
letter designations are used for  the given use  patterns:

     A = Terrestrial, food
     B = Terrestrial, non-food
     C = Aquatic, food
     D = Aquatic, non-food
     E = Greenhouse, food
     F = Greenhouse, ndn-food
     G = Forestry
     H = Domestic outdoor
     I - Indoor

Any other designations will be defined  in  a  footnote to  the table.

-------
                              44

                           TGUIDE-2

 4.   Does  EPA have data? (Column 4).  This column  indicates one
 of  three  answers:

      YES  -  EPA has data in its files that satisfy this data
      requirement.  These data may be cited by other  registrants
      in accordance with data compensation requirements of
      Part 152, Subpart E.

      PARTIALLY - EPA has some data in its files,  but  such data
      do not fully satisfy the data requirement.   In  some cases,
      the  Agency may possess data on one of two required species,
      or may possess data on one test substance but not all.
      The  term may also indicate that the data available to
      EPA  are incomplete.  In this case, when  the  data are
      clarified, or additional details of the  testing  submitted
      by the original data  submitter, the data may be determined
      to be acceptable.  If this is the case,  a footnote to
      the  table will usually say so.

      NO - EPA either possesses no data which  are  sufficient
      to fulfill the data requirement, or the  data which EPA
      does possess are flawed scientifically in a  manner that
      cannot be remedied by clarification or additional infor-
      mation.

 5.   Bibliographic citation (Column 5).  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
 Appendices for a complete  citation of the study.

 6.   Must additional data be submitted? (Column 6).  This
 column indicates whether the data must be submitted  to the
 Agency.   If column 3 indicates that the Agency already has
 data, this column will usually indicate NO.  If column 3
 indicates that the Agency  has only partial data or no data,
 this column will usually indicate YES.  In some cases, even
 though the Agency does not have the data, EPA will not require
 its  submission because of  the unique characteristics of the
chemical;  because data on  another chemical can be used to
 fulfill the data requirement; or because the  data requirement
 has been waived or reserved.   Any such unusual situations
 will be explained in a footnote to the table.

 7.  Timeframe for submission (Column 7).  If  column  5 requires
 that data  be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
 tration Standard.   The timeframes are those established either
as a result  of a  previous  Data  Call-in letter, or standardized
 timeframes established by  PR Notice 85-5 (August  22,  1985).

8.  Footnotes (at the end  of each table).  Self-explanatory.

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              TABLE A,  GENERIC DATA REQUIREMENTS FOR THE TECHNICAL GRADE OF THE ACTIVE INGREDIENT
                                                      ETHEPHON
Test
Data Requirement Substance1
158 subpart c Product Chemistry
Product Identity^ and Composition
61-2 - Description of Beginning Mater- TGAI
ials and Manufacturing Process
61-3 - Discussion of Formation of TGAI
impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product TGAI
Samples
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boiling Point TGAI
63-7 - Density, Bulk Density or TGAI
Specific Gravity
63-8 - Solubility TGAI or PAI
63-9 - Vapor Pressure TGAI or PAI
63-10 - Dissociation Constant TGAI or PAI
63-11 - Octanol/Water Partitioning PAI
Coefficient
63-12 - pH TGAI
63-13 - Stability TGAI
Other Requirements;
Does EPA
Have Data2


NO

NO



No

No
NO
NO
NO
NO
NO
NO
NO
NO
NO
No
NO
n /»
Bibliographic
Citations


N/A

N/A



N/A

N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Kl/»i
Must Addi-
tional Data
Be Submitted?


Yes4
r-
Yes5



*^

Yes7
*v~
Yes7
Yes7*8
Yes7*?
Yes7
Yes7
Yes7
Yes7
Yes7,10
Yes7,ll
Yes7
M/1
Timeframe
For
Submission


6 months

6 months



12 months

6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months

64-1  - Submittal of Samples

-------
         TABLE A.  GENERIC  DATA  RhJQUIKtMKNTS  bUk THE TECHNICAL GRADE OF THE ACTIVE INGREDIENT E1HEPHCJN
      = technical grade  of  the active  ingredient.   FAI  = purified  active  ingredient.

2Not applicable.  Although  product  chemistry  data may have  been  submitted  in the past, the Agency has
 determined  that these data must be resubmitted  for each pesticide.  New  requirements have been introduced
 and previously submitted data must be updated.  Therefore, bibliographic  citations for the old data are
 not applicable.

^Data must be  submitted  within the  timeframe, based on  the  date  of this Guidance Document.

^Complete information must  be provided regarding the nature of the process (batch or continuous), the
 relative amounts of beginning materials  and  the order  in which  they are  added, the chemical equations
 for each intended  reaction,  equipment used to produce  each intermediate  and the final product, reaction
 conditions, the duration of  each step of the process,  purification procedures, and quality control
 measures.   In addition, the  name and  address of the manufacturer,  producer, or supplier of each
 beginning material used in the manufacture of each product must be provided, along with information
 regarding the properties of  those  materials.

^A detailed  discussion of all impurities  that are or may be present aO  0.1 percent, based on knowledge
 of the beginning materials,  chemical  reactions  (intended and  side) in the manufacturing process, and
 any contamination  during and after production must be  submitted.

*>Five or more  representative  samples must be  analyzed for the  amount of active ingredient and each
 impurity tor  which certified limits are  required.   Complete validation data (accuracy and precision)
 must be submitted  for each analytical method used.

7physicochemical characteristics  (color,  physical state, odor, melting point, boiling point, specific
 gravity  solubility, vapor pressure,  dissociation  constant, partition coefficient, pH, and stability)
 as required in 40  CFR 158.120 and  more fully described in  the Pesticide  Assessment Guidelines,
 Subdivision D, must be  submitted.
      needed if the technical chemical is a solid at room temperature.

      required if the technical product is a liquid at room temperature.

        required if the technical product is organic and nonpolar. ^

 11 Data  required if the test substance is dispersible in water.

-------
                                TABLE A.  GtNbKIC DATA RHOJJIRtMKNTS  W)R KTHEPHON
Must Addi- Timeframe
Test Does RPA Bibliographic tional Data For
Data Requirement Substance^ Have Data? Citation Be Submitted? Submission^
158.240 Residue Chemistry
171-2
171-3
171-4
- Chemical Identity3 TGAi
- Directions for use TEP Yes
- Nature of the residue PAIRA Yes
(Metabolism)
- Plants


00038793,
00054018,
00067489,
00088983,
00108993,
00117893,
00122410


00038796,
0001)4021 ,
00081783,
00097422,
00116123,
00121613,

No
No
171-4 - Nature of the residue
        (Metabolism)
        - Livestock
PAIRA and     Partially
plant metabo-
lites
00118508, 00141506,
00165339
                                                                                      Yes 4,5    18 months

-------
TABLE A.
                                             DATA KhX^UlKEMKNTS K)K ETliEPHON (Continued)
Mist Addi- Timeframe
Test Does EPA Bibliographic tional Data For
Data Requirement Substance1 Have Data? Citation Be Submitted? Submission2
171-4 - Residue analytical TGAI and Partially 00030190,
methods metabolites 00038795,
00038880,
00042977,
0004791 1 ,
00053149,
00108992,
00117893,
00122410,
00122433,
00123237,
00142265,
00036500 Yes& 1 5 months
00038797,
00038881 ,
00041465,
00047913,
00103287,
00116123,
00121613,
00122421,
00122435,
00128726,
00145613,
171-4 - Storage stability


171-4 - Magnitude of  the residue
        in plants

        Fruiting Vegetables
        - Peppers

        - Tomatoes
       TEP and
       metabolites
Partially    00151127
       TtP

       TEP
Partially

Partially
00061719, 00121613

00121613
                                                                                      Yes 7
                                                                        18 months
Yes'"
Yes 11
6 months

18 months
24 months
                                                                CD

-------
TABLE A.  GENERIC DATA REQUIREMENTS FDR ETHEPHON (Continued)
Test Does EPA
Data Requirement Substance1 Have Data?
Cucurbit Vegetables
- Cucumbers
- Melons TEP
- Pumpkins TEP
Citrus Fruits
- Lemons TEP
- Tangerines TEP
Pome Fruits
- Apples TEP
Stone Fruits TEP
- Cherries (sweet and
sour)
Small Fruits and Berries
- Blackberries and TEP
Boysenberries
- Blueberries TEP
- Cranberries TEP
Partially
Partially
Yes
Partially
Partially
Partially
Partially

Partially

Partially
Partially
Must Addi-
Bibliographic tional Data
Citation Be Submitted?
PP//9E2225(098344)
001 1 7893
00122717
00121613
00121613
00061717, 00108992,
00123222
00081782, 00136287

00121613

00121613
00121613
Yes' 2> 9
Yes13,9
Reserved 9
Yes'4,9
Yes1 5
Yes16
Yes18'
Yes19,9

Yes20

Yes21 ,9
Yes22
Timeframe
For
Submission2
b months
18 months

18 months
24 months
18 months
6 months
24 months
6 months

18 months

6 months
18 months

-------
TABU-: Ak  GENERIC DATA REQUI REMITS  bOR  LTHEPHON  (Continued)
Data Requiranent
- Grapes
Tree Nuts
- Filberts
- Macadamia nuts
- Walnuts
Cereal Grains
- Barley
- Wheat
Forage, Fodder, and
Straw of Cereal Grains
- Barley straw
- Wheat straw
Miscellaneous
Commodities
- Coffee beans
Test
Substance^
TCP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Does EPA
Have Data?
Partially
Partially
Yes
Partially
Partially
Partially
Partially
Partially
Partially
Bibliographic
Citation
00053150, 00080482,
00121613
00038797
00128726
00038795, 00117752
00103287
00103287
00103287
00103287
00041465
Mjst Addi-
tional Data
Be Submitted?
Yes23
Yes24
YeS25.9
Reserved^
Yes26,9
Yes27,9
YeS28,9
y r\^*£- "
YoG-JVJ
V^o J • • J
Yes33
Yes34
Time frame
For
Submission2
18 months
18 months
6 months

6 months
18 month « —
O
18 month
24 month
18 months
18 months
18 months
24 months
6 months

-------
                  TAhLE A.  GENERIC DATA REQUIREMENTS K)R ETHEPHON  (Continued)
Data Requirement
- Cottonseed
- Figs
- Uuavas
- Pineapples
- Sugarcane
- Tobacco
171-4 - Magnitude of residue in
Test
Substance^
TEP
TEP
TEP
TEP
TEP
PAIRA
TGAI
Does EPA
Have Data?
Partially
Partially
Yes
Partially
Partially
Partially
Partially
Mist Addi-
Bibliographic tional Data
Citation Be Submitted?
00030190, 00122423
00036500
PP#9E2262
00040268, 00040269,
00054022, 00116123,
00122452, 00123222
00032573, 00145613
00122410
00083773, 00100517,
Yes35
Yes36
Yes37,9
Yes38
Yes3y,9
Yel4'
Yes42
Yes43
Yes44
Yes4^
Timeframe
For
Submission2
18 months
6 months
6 months
24 months
18 months
18 months
24 months
6 months
24 months
18 months
18 months
Meat/Milk/Poultry/Eggs
                                                    00121613

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                          TABLE A.   GENERIC  DATA REQUIREMENTS FOR ETHEPHON (Continued)
J-Test substance:  TGAI = technical  grade of  the active  ingredient; PAI = purified active ingredient;
 PAIRA = purified active ingredient,  radiolabeled; TEP  = typical end-use product; EP = end-use product.

2]3ata must be submitted within the indicated timeframe, based on the date of this Guidance Document.
     same chemical identity data are required as under 158. 120, with emphasis on impurities of  toxicological
concern that constitute residue problems.   Refer to Product Chemistry Data Requirement tables.

4A poultry metabolism study must be submitted.  Animals must be dosed orally for a minimum of 3 days with [UL-14C
 at a level sufficient to make residue identification and quantification possible.  Eggs must be collected
 twice a day during the dosing period.   Animals must be sacrificed within 24 hours of the final dose.  The
 distribution and identity of l^C-residues (including l^c-residues incorporated into natural products)
 must be determined in eggs, liver, kidney, muscle, and fat.  Samples from these studies must also be
 analyzed using the Union Carbide-animal method [MRID # 00142265] to ascertain that this method is capable
 of adequately recovering and identifying  all residues of toxicological concern.

5oata depicting the nature of ethephon residues in swine are also required unless the metabolism in             
-------
                           TABLE A.  GENERIC DATA RW^UlKtMENTS tt)k hTHEPHON (Continued)
8The registrant must amend all pertinent product labels to specity a PHI.   The  available  data  indicate
 that a PHI of 5  days or longer would be appropriate.

^Additional residue data may be required on receipt of the storage stability data required  in  footnote
 w I •
      must be submitted depicting residues  of ethephon and monochloroacetic  acid  in or on  tomatoes
 resulting from  a  single foliar application of the 2 Ib/gal SC/L formulation at 1.6 Ib ai/A, in 20 gal/A
 using ground equipment and, in seperate tests,  in 10 gal/A using aerial  equipment.  The data must depict
 the increase and  decline of residues over  a suitable range of posttreatment intervals.  The registrant
 must propose a  PHI  based on these data. The tests must  be conducted  in  CA  (75%) and FL (8%), states
 that represented  ca.  80 percent of 1985 total U.S. tomato production.
      must be submitted  depicting the potential for concentration  of  residues  in juice, dried pomace,
 puree, and catsup processed from tomatoes  bearing measurable weathered  residues.   If residues concentrate
 in any processed  fraction,  an appropriate  food/feed additive tolerance  must be proposed.
     registrant must  propose a PHI based on the minimum interval  expected between the second application
 (5 days after the  plants  are at the four-leaf  stage)  and  harvest.  The available data indicate that a
 PHI of 17 days or  longer  would be appropriate.
      must be submitted depicting ethephon  and monochloroacetic acid  residues  in or on cantaloupes
 harvested 2 days  (or a PHI proposed by the registrant)  following aerial application of the 2 Ib/gal
 SC/L formulation  at  0.75 Ib ai/A.   Tests must be  conducted  in TX.  The registrant must propose a PHI
 for application of ethephon to cantaloupes;  the available data indicate that, following application
 using ground equipment, a PHI of 2  days would be  appropriate.
     registrant must  either (i)  provide documentation  that  lemons will not be shipped or sold for >^ 2
 weeks after treatment,  or (ii)  submit  data depicting  ethephon and monochloroacetic acid residues in or
 on lemons  immediately after a single postharvest application of the 2 Ib/gal SC/L formulation at 0.83
 Ib ai/100  gal of  water/ 1 00-1 30  tons of fruit.

-------
                           TABLE A.  GENERIC DATA RHQUIREMENTS FOR ETHEPHON (Continued)
'-'Data must be submitted depicting the potential for concentration of ethephon residues in dried pulp, oil, and
  molasses during the processing of treated lemons bearing measurable residues.  If the data indicate a potential
  for residue concentration In any of these commodities, the registrant must propose an appropriate  food/feed
  additive tolerance.

'&Data must be submitted depicting ethephon and monochloroacetic acid residues in or on whole tangerines harvested
  at regular Intervals following a single foliar application of t he 2 Ib/gal SC/L formulation at 1 425 Ib ai/A in
  400 gallons of water/A.  The data must depict levels of ethephon residues and a PHI must be proposed based on
  the requested data.  Tests must be conducted in FL.

1?The registrant must propose a PHI.  The available data indicate that a PHI of 7 days would be appropriate.
            be Submitted depicting the potential for concentration of residues in dried pomace from treated
  apples bearing measurable weathered residues.  If the data indicate a potential for residue Concentration in
  this commodity, the  registrant must propose an appropriate feed additive tolerances
      registrant must  amend all pertinent  labels to  include a PHl based «H the Mtiittiutfi itifcervii expected
  betveeh application  and harvest.  The available data  indicate  thafe a PHI of 7 days or l8HgeT Vtould be        (jn
  appropriate*                                                                                                 -^*

20nata must be  submitted depicting  residues 8f ethephon and monpdhlotOacetie aeid itt or OH blackberries or
  bovsenberries resultihfe from a  single MU? §^PHeati»n of the ^ lb/gal SC/U foriffillatioh at 2.18 Ib at/A, ih
  175 Si/AuX« RroUHd %utpmeht.  Ihe data mtisfe dfetiict the levels of tesiduea over a suitable rame of p»t-
 trfeatJeht intervals    The registrant must propose a PM1 based on these dafeis  The tests tttust be eendufetetJ  in OK
  which accounted for  ca. 80  percent ef \Wt u,8» blaefeberry produefetem  A tol§Mhd§ for *-e§idue§ in or on
  boysenberrtes must be proposed.

2lThe registrant must  propose a PHI for application  of  ethephon  to blueberries.  The available data
  indicate that a 7-day PHI would be appropriate.




  a  PHI based on these data.  Tests must be conducted in MA, NJ, and WI.

-------
                            TABLE A.  GENbKLC IWi'A KtJQUIRHMENTS R)R hTHKPHON (Continued)
23Uata must be submitted depicting residues of ethephon and monochloroacetic acid in or on grapes  and raisin
  waste harvested  at  regular intervals following a single foliar application of the 2 Ib/gal  SC'/L  formulation at
  0.5 Ib ai/A.   Data  must depict the level of residues over a suitable range of posttreatment intervals.  Tests
  must be conducted in CA where this use is registered.  The registrant must propose adequate tolerance revisions
  (if necessary) for  residues of ethephon in or on grapes and raisin waste based on appropriate supporting residue
  data.  In addition, the registrant must propose a PHI based on the requested residue data.
       an appropriate tolerance for residues in or on grapes is determined,  food/feed additive tolerance at 4x
  must be established for grape juice and dried grape pomace, and a food additive tolerance at 7x must be established
  for raisins.
  xhe registrant  must amend all pertinent labels to include a PHI based on the minimum interval expected
  between application and harvest.  The available data indicate that a PHI of 7 days or longer would be
  appropriate.

26ihe registrant  must amend all pertinent labels to include a PHI based on the minimum interval expected
  between application and harvest.  The available data indicate that a PHI of 5 days or longer would be          U
  appropriate.

27xhe registrant  must amend all pertinent product labels to include a PHI.  The available data
  (reflecting ground application) indicate that a PHI of 40 days would be appropriate.

28Residue data  must be submitted of ethephon and monochloroacetic acid in or on wheat grain harvested following
  one aerial  application of a representative SC/L formulation at 0.5 Ib ai/A in 3 gal/A.   Tests must be conducted
  in KS  H8%) or  00 (6%)  ND (13%) or NM (6%), and in WA (5%) which collectively represent the tna.ior wheat growing
  areas  in  the  United States and ca. 50 percent of the 1985 U.S. wheat production The registrant must amend all
  pertinent product labels to specify a PHI based on the residue data.  The available data (from tests using
  ground application indicate that a PHI of 40 days would be appropriate.

29nora must be  submitted depicting concentration of residues in middlings and wheat grain dust resulting from
  ?he p^cessing^ wheat grain blaring measurable weathered residues.  If the data indicate  a potential for
  concen^ation^of residue! in grain dust, an appropriate feed additive tolerance must be proposed.

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                          TABLE A.  GENERIC  DMA RE^U 1 KKMENTS  FUR ETHEPHON  (Continued)
30Data required  to  support  the tolerance  for  residues  in  or  on wheat  straw will be  translated to
  barley straw.

3'Data must be submitted depicting residue  ot ethephon and monochloroacet ic acid  in or on wheat straw harvested
  following one  aerial application of a representative SC/L  formulation  at 0.5 Ib ai/A in 3 gal/A.  Tests must be
  conducted in KS  (18%) or  CO (6%), ND (13%)  or MN  (6%),  and in WA (5%)  which collectively represent the major
  wheat growing  areas in the United States  and ca.  50  percent of  the  1985 U.S. wheat production The registrant
  must amend all pertinent  product labels to  specify a PHI based  on the  residue data.  The available data (from
  tests using ground application)  indicate  that a PHI  of  40  days  would be appropriate.

32Qata must be submitted depicting ethephon and monochloroacet ic  acid in or on green coffee beans harvested at
  regular intervals following a single foliar application of the  4 Ib/gal SC/L formulation at 600 rag/plant to a  4
  meter coffee plant.  Tests must  be conducted in Guatemala,  Costa Rica, and Brazil which accounted for the majority
  of the 1985 coffee bean importation to  the  U.S. from North and  South America.   The registrant must amend all
  pertinent product labels  to specify a PHI.                                                                      —

33oata must be submitted depicting the potential  for concentration of residues in roasted beans and instant
  coffee processed  from beans bearing measurable  weathered residues.  If residues concentrate in any of these
  processed commodities, an appropriate food  additive  tolerance must  be  proposed.                               CD
                                                                                                                ON
34The registrant must submit an English translation of all labels bearing directions for use of
  ethephon on coffee grown  for importation  into the U.S.

35[j&ta must be submitted depicting residues of ethephon and  monochloroacet ic acid in or on cottonseed harvested
  14 days after  the last of two applications  (one application made at 2  Ib ai/A when 50 percent of the bolls are
  open and the second treatment made at 1 Ib  ai/A 4 days  later) of the 2 Ib/gal FLC and a representative EC
  formulation (each in separate tests) applied with aerial equipment  in  2 gal. water/A and, in separate tests,
  usine eround equipment in 5 gal. water/A.   The  data  must depict the posttreatment interval at which residues
  decline.  Tests must be conducted in AZ (7%), AR  (5%),  CA  (23%),  GA (3%), MS (12%), MM « 1%), OK (2%), and TX
  (29%) which collectively  accounted for  ca.  80 percent of 1985 U.S.  cotton production.  The registrant must
  propose an appropriate PHI based on the requested residue  data.

-------
                            TABLE A.  GENERIC [ATA REQUIREMENTS K)R ETHEPHON (Continued)
36WTien an appropriate tolerance for residues in or on cottonseed is determined,  food/feed additive
  tolerances  at  6x in meal, 2x in refined oil, and 4x in soapstock must be proposed.

37The registrant must amend all pertinent product labels to specify a PHI.   Available data indicate
  that a PHI  of  14 days or longer would be appropriate.

38Qata must be submitted depicting the potential for concentration of residues  in dried figs  processed from
  fresh figs  bearing measurable weathered residues.  If  residues concentrate in dried figs, an appropriate food
  additive tolerance must be proposed.
      registrant must  submit data regarding the gal.  water/A rate used in previously submitted  field trials
  (PP09E2262) and  a  PHI  of _> 7 months must be proposed.   If the gal.  water/A data  are not  available or at least
  250 gal/A were not applied, data depicting residues of ethephon and monochloroacetic acid  in  or on guavas harvested
  following a postharvest application made at 3.13 Ib ai/25U gal. water/A must  be  submitted.  The finished spray
  must contain a nonionic surfactant.  A PHI must be  proposed based on the residue data.   The tests must be conducted
  in HI where this use is registered.  Alternatively, the registrant  may elect  to  cancel this use permitted under  -^
  EPA SLN No.  HI800012.
       must be submitted depicting residues  of ethephon and monochloroacetic acid  in  or  on  pineapple fruit and
  forage harvested  at  regular intervals following the last of two foliar applications of a  representative SC/L
  formulation at  1.5 Ib ai/A, one application made to foliage 6 to 8 months  prior  to  harvest and one late-season
  application to  plants bearing immature fruit.   The data must depict  the posttreadnent  interval at which residues
  begin to decline.  The registran must amend the pertinent labels to  specify a  PHI and  a pregrazing interval;
  these intervals must be reflected in the requested data.   Tests must be conducted in HI,  which accounts for ca.
  100 percent of  the U.S. total pineapple production.

41 A processing study must be submitted depicting residues in products  (bran  and  juice) processed from pineapples
  bearing measurable,  weathered residues. If residues concentrate in  any product, appropriate food/ feed additive
  tolerances must be proposed.

    PHI of > 2 months  must be proposed.

-------
                           TABLE A.  GENERIC  tATA  KE^ULHfcMENTS  R>R  hTHEPHON  (Continued)
       must be  submitted  depicting the  potential  for  concentration of  residues in refined «ugar processed from
  sugarcane bearing measurable weathered  residues.  If  the data indicate a potential for concentration of residues,
  an appropriate  food  additive tolerance  must  be  proposed.

^Pyrolysis products derived from ethephon must be  characterized and the level of residue in tobacco
  smoke must be quantified*   Weathered  residues of  [^C]ethephon must  be used for identification of
  pyrolysis products*

45Kollowing receipt and evaluation of the required  poultry metabolism  data,  storage stability data,
  and residue data for feed  items, specific  data  requirements for livestock  feeding studies will be
  determined.
                                                                                                             Ul
                                                                                                             GO

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               TABLE A
GENERIC DATA REQUIREMENTS FDR ETHEPHON
Data
Test use
Requirement Substance^ pattern
Does EPA Bibliographic
Have Data2 Citation
Must Addi- Timeframe
tional Data For
Be Submitted? Submission
158.340 Toxicology
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6

81-7
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation - Rabbit
- Dermal Sensitization -
Guinea Pig
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI

TGAI
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G

A,B,G
Yes 00029509
Yes 00029510
No
No
Yes 00029513
NO

Yes 00144559
No
No
Yes 9 months
No4
' *•**
NO
Yes 9 months c/i
^
NO
SUBCHRONIC TESTING:
82-1


- 90-Day Feeding -
Rodent
Non- rodent

TGAI
TGAI

A,B,G
A,B,G

No
NO

NO5
NO6

-------
               TABLE A
GENERIC DATA REQUIREMENTS FDR ETHEPHON
Data Requirement
158.340 Toxicology (Cont.)
82-2 - 21-Day Dermal-
82-3 - 90-Day Dermal-
82-4 - 90-Day Inhalation-
82-5 - 90-Day Neurotoxicity-
82-X - 21-Day Smoke Inhalation-
CHRONIC TESTING:

83-1 - Chronic Toxicity -
Rodent
Non- rodent
83-2 - Oncogenicity Study -
Rat
Mouse
83-3 - Teratogenicity -
Rat
Test
Substance^
TGAI
TGAI
TGAI
TGAI
TGAI


TGAI
•TGAI

TGAI
TGAI

TGAI
use
pattern
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G


AfB,G
A,B,G

A,B,G
A,B,G

A,B,G
Does EPA
Have Data2
NO
No
NO
NO
NO


Partially
Partially

Partially
Partially

Yes
Must Addi- Timeframe
Bibliographic tional Data For
Citation Be Submitted? Submission
Yes 12 months
NO?
No8
No9
Yes10 12 months
O

00060358 Yes11 3 Months
00144558
Yes12 3 Months

00060358 Yes13 3 Months
00144558
00165591 Yes14 3 Months

00063745 No

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               TABLE A
GENERIC DATA REQUIREMENTS FDR ETHEPHON
Data Requirement
158.135 Toxicoloqy (Oont.)
83-3 - Rabbit
83-4 - Reproduction -
MUTAGENICITY TESTING
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Mutagenicity
SPECIAL TESTING
85-1 - General Metabolism
85-2 - Domestic Animal Safety
Test
Substance^
TGAI
TGAI
TGAI
TGAI
TGAI
PA I or PAIRA
Choice
use
pattern
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G
ArB,G
Does EPA
Have Data2
Yes
No
Yes
Yes
No
NO
NO
Must Addi-
Bibliographic tional Data
Citation Be Submitted?
00085755 No
Yes
00029515 No
00077061 No
Yes15
Yes
NO16
Timeframe
For
Submission
39 months
12 months
24 months

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                                                     TABLE A
                                      GRNERIC DATA REQUIREMENTS FOR ETHEPHON
 ^Composition:  TGAI Technical Grade Active Ingredient; PAI = Pure Active Ingredient;  PAIRA = Pure Active
  Ingredient, Radiolabelled; Choice = Choice of several test substances determined on a case-by-case basis.

 2The use patterns are coded as follows:   A = Terrestrial, Food Crop; B = Terrestrial, Non-Food;  C = Aquatic,
  Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor; I = Indoor;
  IP = Industrial Preservative.

 ^Unless otherwise specified, data must be submitted no later than six months after publication of this
  standard.

 ^Primary Eye Irritation Studies are not required for substances which are corrosive in Primary Dermal
  Irritation Studies.  Since ethephon is corrosive, an Primary Eye Irritation Study is not required.

 ^This requirement is waived based on the submission of an acceptable chronic feeding study in the rat.

 6This requirement is waived based on the submission of an acceptable chronic feeding study in the dog.

 ^This study is not required because existing acceptable end-uses should not result in repeated human           ON
  skin contact.                                                                                                 rxj

 8This study is not required because existing acceptable end-uses should not result in repeated
  inhalation exposure.

 9Since the Acute Delayed Neurotoxicity study in hens showed no dose related neuro-histopathology, a
  study is not required.
       study is required only if residues of degradation products of ethephon or ethephon residues on flue
  cured tobacco are greater than 0.1 ppm.  However, since formal guidelines for such a study have not been
  developed, the registrant should consult with the Agency before performing the study.

11This study cannot be fully evaluated from the data available.  Data on the stability of ethephon in
  the feed must be submitted.  In addition, historical control data must be submitted on pancreatic islet
  cell carcinomas and adenomas in Sprague Dawley rats, preferably conducted in the testing facility
  conducting the original study or the study must be repeated.

-------
                                                     TABLE A
                                      GENERIC DATA REQUIREMENTS FOR ETHEPHON
    is study cannot be fully evaluated from the data available.  Data on the stability of ethephon in the
  feed must be submitted or the study must be repeated.

      footnote 11.

    is study cannot be fully evaluated from the data available.  Data on the stability of ethephon in the
  feed must be submitted.  In addition, historical control data must be submitted on f ibrosarcomas in the
  Swiss Albino mouse, preferably conducted in the testing facility conducting the original study.
    study is required for gene mutation in mammalian cells.

!6This study is not required under the current use patterns.
                                                                                                           ON

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               TABLE A
GENERIC DATA REQUIREMENTS FDR ETHEPHON
Data Requirement
158.290 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
PHOTODEGRADATION :
161-2 - In Water
161-3 - On Soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
163-1 - Leaching and
Adsorption/Desorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
Test
Substance^

PAIRA
PAIRA
PAIRA or TGAI
PAIRA or TGAI
PAIRA
PAIRA or TGAI
PAIRA or TGAI
PAIRA or TGAI

PAIRA
TEP
TEP
use Does EPA
pattern Have Data2

No
NO
NO
NO
A,B,F, NO
G,H
A,B NO
G NO
NO

AfB,F, NO
G,H
A,B,F NO
A,B,F NO
Must Addi- Timeframe
Bibliographic tional Data For
Citation Be Submitted? Submission

Yes 9 months
Yes 9 months
Yes 9 months
Reserved4
Yes 27 months
Yes5 27 months
Yes 27 months
NO6

Yes^ 12 months
Reserved4
Reserved4

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                                                    TABLE A
                                     GENERIC DATA REQUIREMENTS FOR ETHEPHON
Data Requirement
158.290 Environmental Fate
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-Term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - irrigated Crops
165-4 - in Fish
Test use
Substancel pattern
(Cont.)
TEP A,B
TEP —
TEP G
TEP

TEP A,B
PAIRA A,B
TEP A,B
TEP —
PAIRA/TGAI A,B,G
Does EPA
Have Data2
No
NO
NO
NO

NO
NO
NO
NO
NO
Must Addi-
Bibliographic tional Data
Citation Be Submitted?
Yes
NO6
Yes
NO8

Reserved^
Yes
Reserved1^
Noll
Yesl2
Timeframe
For
Submission
27 months

27 months


39 months


12 months
165-5 - in Aquatic Non-
        Target Organism
TEP
No
Reservedl3

-------
                                                     TABLE A
                                      GENERIC Q(VTA REQUIREMENTS FDR ETHEPHON
 1 Composition:  TGAI - Technical Grade of the Active Ingredient; PAIRA = Pure Active Ingredient  Radiolabelled-
  TEP = Typical End Use Product.

 2The use patterns are coded as follows:  A = Terrestrial Food Crop; B = Terrestrial, Non-Food; C =• Aquatic,
  Food Crop; D = Aquatic Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry;
  H = Domestic Outdoor; I - Indoor.

 ^Data must be submitted within the indicated timetrame, based on the date of this Guidance  Document.

 *»This study is reserved, pending receipt and evaluation of other environmental fate data.                         '

 ^lf an anaerobic aquatic study is submitted, then the anaerobic soil §tudy need not be done.

 &Not required because ethephon has no aquatic or aqua tie impact uses.                                           o\
                                                                                                                 ON
 ^This data requirement remains unsatisfied because of discrepancies between Studies (ethephon was mobile
  in three soils, including a peat in one study, and immobile in sandy clay loam soils in the other).
  The registrant must either give an adequate explanation for the discrepancies or submit a new study on
  the mobility of imaged ethephon.  In addition, a study on the mobility of aged ethephon is required.
       data requirement is not being imposed at this time.

 ^These data may be required, depending on the results of the field dissipation studies.

lOThese data may be required, depending on the results of the confined rotational crop study.

H Not required because ethephon has no aquatic uses.

^Registrant should submit an octanol-water partition coefficient.  On the basis of this and other data,
  the agency will then determine if a study is needed.

13rhis data requirement is reserved, pending results of data required under 165-4.

-------
                                                     TABLE A
                                     GENERIC  DATA  REQUIREMENTS FOR ETHEPHON
Data Requirement
158.390 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
Test
Substance*
TEP
TEP
TEP
TEP
use
pattern
A,B
A,B
A,B
A,B
Does EPA
Have Data2
No
NO
NO
NO
Must Addi- Timeframe
Bibliographic tional Data For
Citation Be Submitted? Submission
Yes3/4
Yes3/5
Conditional^
Conditional^
ON
1 TEP = Typical End Use Product.

2 A = Terrestrial Food Crop Uses; B = Terrestrial Non-Food Uses.

3 Data must be submitted no later than 18 months after issuance of this document.

4 For each end use, you must propose an acceptable reentry interval based upon dissipation of residues (decline
curve), considering human exposure and toxicity of the residues or on the time when there are no detectable
dislogeable or inhalable residues in the field.

5 soil dissipation data are required only for uses where workers will be exposed directly to the soil during
their work.

6 Human exposure monitoring data are not required at this time.  If dermal exposure data are submitted,  then
the inhalation exposure data must also be submitted.

-------
               TABLE A
GENERIC DATA REQUIREMENTS FOR ETHEPHON
Test use Does EPA
Data Requirement Substance1 pattern Have Data2
158.440 Spray Drift
202-1 - Drift Field Evaluation TEP A,B No
202-1 - Drift Size Spectrum TEP A,B No
Must Addi- Timeframe
Bibliographic tional Data For
Citation Be Submitted? Submission
Reserved3
Reserved3
ITEP = Typical End Use Product.

2A = Terrestrial Food Crop; B = Terrestrial Non-Food.

3This data requirement is being reserved, pending receipt and evaluation of phytotoxicity data required
 by the Ecological Effects Branch.
                                                                         00

-------
                                          GENERIC DATA TABLE FOR ETHEPHON
Data Requirement
158.490 WILDLIFE AND AQUATIC
Avian and Mammalian Testing
71-1 - Avian Oral LDso
71-2 - Avian Dietary LCso
Upland game
Waterfowl
71-3 - Wild Mammal
71-4 - Avian Reproduction
Test
Substance^
ORGANISMS
TGAI
TGAI
TEP
TGAI
TGAI
TGAI
use
pattern
A,B,G
A,B,G
A,B,G
A,B,G


Does EPA
Have Data2
Yes
Yes
Yes
Yes
NO
NO
Bibliographic
Citation
00027493
00085446
00107428
00005684


Must Addi- Timeframe
tional Data For
Be Submitted? Submission
No
No
NO
NO
NO3
No6 ^
71-5 - Simulated and Actual
         Field testing -
         Mammals and Birds

Aquatic Testing
72-1 - Freshwater Fish
         Warm water

         Cold water
72-2 - Acute LCso Freshwater
       Invertebrates
TEP
             No
TGAI

TGAI
TGAI
TEP
A,B,G

A,B,G
A,B,G
A,B,G
Yes

Yes
Yes
Yes
00027495
00122412
00027495
00122412

00054013
00122448
                                                      No6
NO

NO
No

NO
NO

-------
GENERIC DATA TABLE FOR ETHEPHON
Data
luatic
1-3 -
!— 4 —
>_5 _
Requirement
: Testinq (Cont.)
Acute LC5Q Estuarine and
Marine Organisms
Fish Early Life Stage and
Aquatic Invertebrate
Life Cycle
Fish Life Cycle
Test
Substance^
TGAI
TGAI
TGAI
use
pattern
A,B,G
A,B,G
A,B,G
Does EPA
Have Data2
Partially
No
NO
Bibliographic
Citation
00054013
Must Addi-
tional Data
Be Submitted?
Yes4
NO6
NO6
Timeframe
For
Submission
12 months
72-6 - Aquatic Organism
       Accumulation              TGAI

72-7 - Simulated or actual
       Field Testing -
       Aquatic Organisms         TEP

158.150 PLANT PROTECTION

121-1 - Target Area
        Phvtotoxicity            TEP
   A,B,G
   A,B,G
   AfB,G
NO
NO
NO6
NO6



Reserved^
                                            No

-------
GENERIC DATA TABLE FOR ETHEPHON
Data
Requirement
Test
Substance^-
use
pattern
Does EPA
Have Data2
Must Addi- Timef rame
Bibliographic tional Data For
Citation Be Submitted? Submission
Non-Tarqet Area Phytotoxicity

122-1
122-1
122-2

123-1
123-1
123-2
124-1
124-2
Tier I
- Seedling Germination/
Seedling Emergence
- Vegetative Vigor
- Aquatic Plant Growth
Tier II
- Seed Germination/
Seedling Emergence
- Vegetative Vigor
- Aquatic Plant Growth
Tier III
- Terrestrial Field
- Aquatic Field

TGAI
TGAI
TGAI

TGAI
TGAI
TGAI
TEP
TEP

A,B,G
A,BfG
A,B,G

A,B,G
A,B,G
A,B,G
A,B,G
A,B,G

No
NO
NO

No
No
NO
NO
No

Yes 12 months
Yes 12 months
Yes 12 months

Reserved? ^j
Reserved?
Reserved?
Reserved**
Reserved**

-------
                                   GENERIC IWPA TABLE R)K fcTittKPHON  (continued)
1 Compos it ion:  TGA1 « Technical Grade of  the Active  Ingredient, PAI = Pure Active Ingredient, TfcP = Typical
 Knd-Use Product.
     patterns are coded as  follows:  A = Terrestrial,  food crop; B = Terrestrial, non-food; C = Aquatic,
 food crop; D = Aquatic, non-food; E = Greenhouse,  food  crop; F = Greenhouse, non-food; G = Forestry;
 H » Dontestic, outdoor; I ** Indoor.

3 Additional data not  required because of existing rodent studies.
     requirement  for an estuarine/tnarine  shrimp  test  is  fulfilled.  Submit either a 96-hour shell deposition  study,
 or a mollusc 48-hour embryo- larvae study.   Because the  LC5Q values of  freshwater and saltwater crustaceans
 indicate similar toxicities between fresh  and saltwater taxa, and because the toxicity to freshwater fish is low,
 the requirement  is  waived  for the  estuarine/marine fish component of the testing.

^Reserved pending the results  of outstanding studies.

&Not currently a  requirement.                                                                                    _ ^

^Reserved pending results of Tier I studies.

^Reserved pending the results  of the Tier II  studies.

-------
                                                    TABLE A
                                     GENERIC DATA REQUIREMENTS FOR ETHEPHON
                                                                                  Must Addi-      Timeframe
                               Test          use     Does EPA     Bibliographic   tional Data        For
Data Requirement	Substance1  pattern   Have Data2   Citation	Be Submitted?   Submissions

158.590 Nontarget Insect

NONTARGET INSECT TESTING - POLLINATORS;

141-1 - Honey bee acute         TGAI         A,B         Yes          00018842          No
        contact LD5Q

141-2 - Honey bee - Toxicity    TEP          A,B         No                             No3                    ^
        of residues on foliage
                                                                                                               -i
141-4 - Honey bee subacute    [Reserved]4
        feeding study                                                                                        ^.

141-5 - Field testing for       TEP          A,B         No                             No3
        pollinators

NONTARGET INSECT TESTING - AQUATIC INSECTS

142-1 - Acute toxicity to     [Reserved]5
        aquatic insects

142-2 - Aquatic insect life-  [Reserved]5
        cycle study

142-3 - Simulated or actual   [Reserved]5
        field testing for
        aquatic insects

143-1 - NONTARGET INSECT      [Reserved]5
thru    TESTING-PREDATORS
143-3   AND  PARASITES

-------
                                                    TABLE A
                                     GENERIC CftTA REQUIREMENTS FOR ETHEPHON
^Composition:  TGA1 = Technical grade of the active ingredient; TEP = Typical end-use product.
     use patterns are coded as follows:  A * Terrestrial, Food Crop; B = Terrestrial, Non-Food;
 C = Aquatic, Food Crop; D - Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse,  Non-Food;
 G « Forestry; H « Domestic Outdoor; I = Indoor.

3As data from the acute contact test indicate  low toxicity, no further testing is required.

^Reserved pending development of test methodology.

^Reserved pending Agency decision as to whether the data requirement should be established.

-------
TABLE B.  PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
                             CONTAINING ETHEPHON
Test
Data Requirement Substancel
Does EPA
Have Data2
Must Addi- Timeframe
Bibliographic tional Data For
Citation Be Submitted? Submissions
158 Subpjrt c Product Chemistry
Product
61-1 -

61-2 -

61-3 -

Identity^ and Composition
Product Identity and Disclosure
of Ingredients
Description of Beginning Mater-
ials and Manufacturing Process
Discussion of Formation of
Impurities

MP

MP

MP


No

No

No


N/A

N/A

N/A


Yes4

Yes5

Yes6


6 months

6 months

6 months

Analysis and Certification of Product
Ingredients
62-1 -

62-2 -

62-3 -

Physical
63-2 -
63-3 -
63-4 -
63-7 -

63-12 -
63-14 -
63-15 -
63-16 -
63-17 -
63-18 -
Preliminary Analysis of Product
Sampl es
Certification of Ingredient
Limits
Analytical Methods to Verify
Certified Limits
and Chemical Characteristics
Color
Physical State
Odor
Density, Bulk Density or
Specific Gravity
pH
Oxidizing or Reducing Action
Flamability
Explodability
Storage Stability
Viscosity
MP

MP

MP


MP
MP
MP
MP

MP
MP
MP
MP
MP
MP
NO

No

NO


NO
NO
NO
NO

NO
NO
NO
NO
NO
NO
N/A

N/A

N/A


N/A
N/A
N/A
N/A

N/A
N/A
N/A
N/A
N/A
N/A

Yes7

Yes8

Yes9


YeslO
YeslO
VooXv/
VooJ. \J

YeslO/ 11
YeslO/ 12
YeslO* 13
YeslO / 14
Yesin
Yes10/ 15

12 months

12 months

12 months


6 months
6 months
6 months
6 months

6 month
6 month
6 month
6 month
15 months
6 month
                                                                                               en

-------
                   TABLE B.   PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
                                               CONTAINING ETHEPHON
                                                                                   Must Addi-      Timeframe
__.,_.     ..                    Test      .    Does EPA        Bibliographic      tional  Data         For
Data Requirement	Substance!    Have Data2      Citation	Be Submitted?   Submission

158 Subpart C Product Chemistry (Cont.)

63-19 - Miscibility                  MP             NO              N/A              yes10/16       6 months
63-20 - Corrosion Characteristics     MP             NO              N/A              v^dO        ic ^n^l
                                                    N°              N/A              Yes10        15 nonths

Other Requirements:
64-1  - Submittal of Samples          N/A           N/A             N/A              NO



^Composition:  MP = Manufacturing-Use Product.

2Not applicable.  Although product chemistry data may have been submitted in the past, the Agency has
 determined that these data must be  resubmitted  for  each pesticide.  New requirements have been  introduced
 and previously submitted data must  be updated.  Therefore, bibliographic citations for the old  data are
 not applicable.

3Data must be submitted within the indicated timeframe, based on the date of this Guidance Document.

4The chemical name, nominal concentration, Chemical  Abstracts (CAS) Registry Number,  and purpose of the
 active ingredient and each intentionally added  inert must be provided.  For the active ingredients, the
 following must also be provided: the product, common,and trade names; the molecular, structural, and
 empirical formulas; the molecular weight or weight  range; and any experimental  or internally assigned
 company code numbers.

5Complete information must be provided  regarding the nature of the process (batch or  continuous), the
 relative amounts of beginning materials  and the order in which they are added,  the chemical equations
 for each intended reaction, equipment  used to produce each intermediate and the final product,  reaction
 conditions, the duration of each step  of the process, purification procedures,  and quality control
 measures.  In addition, the name and address of the manufacturer, producer, or  supplier of each
 beginning material used in the manufacture of each product must be provided, along with information
 regarding the properties of those materials.
                                                                                                              ON

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                    TABLE B.  PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
                                                 CONTAINING ETHEPHON


  *>A detailed discussion of all impurities that are or may be present at  > 0.1 percent, based on knowledge
   of the beginning materials, chemical reactions (intended and  side) in  the manufacturing process, and any
   contamination during and after production must be submitted.

  ?Five Ot more representative samples must be analyzed for the  amount of active ingredient and each
   impurity  for which certified limits are required.  Complete validation data (accuracy and precision)
   must be submitted for  each analytical method used.

  Cupper  and lower limits for the active ingredient and each intentionally added inert, and upper limits
   for each  impurity present at > 0.1 percent (w/w) and each "toxicologically significant" impurity present
   at < 0.1  percent  (w/w) must be provided and certified.   Also, an  explanation of how each certified  limit
   was established must be provided (e.g., sample analysis using validated analytical procedures, quantitative
   estimate  based on amounts of ingredients used, etc.).  Limits for impurities not associated with the active
   ingredient  need be provided only if they are considered to be of  toxicological significance, regardless of
   the concentration at which they are present (2-chloroethanol). Certifications must be submitted on EPA Form
   8570 Rev. 2-85.

  Analytical  methods must be provided to determine the active ingredient, and each toxicologically
   significant impurity and intentionally added inert for  which  certified limits are required.  Bach
   method must be accompanied by validation studies indicating its accuracy and precision.  These methods
   must be suitable  for enforcement of certified limits.

 lOphysiccchemical characteristics (color, physical state, odor, melting  point, boiling point, specific
   gravity,  solubility, vapor pressure, dissociation constant, partition  coefficient, pH, and stability)
   as required in 40 CFR  158.120 and more fully described  in the pesticide Assessment Guidelines,
   Subdivision D, must be submitted.

Hoata required if the test substance is dispersible in water.

12oata required if the product contains oxidizing or reducing agents.

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                   TABLE B.   PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
                                               CONTAINING ETHEPHON


       required if the product contains combustible liquids.

14Data required if the product is  potentially explosive.

l^oata required if the product is  a liquid.

16Data required if the product is  a liquid and  is to be diluted with petroleum solvents.
                                                                                                            CP

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       TABLE B.  PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ETHEPHON
Data Requirement
158.340 Toxicology
ACUTE TESTING:
81-1 - Acute Oral - Rat
81-2 - Acute Dermal
81-3 - Acute Inhalation - Rat
81-4 - Eye Irritation - Rabbit
81-5 - Dermal Irritation - Rabbit
81-6 - Dermal Sensitization -
Guinea Pig
Test
Substance1-


MP
MP
MP
MP
MP
MP

Does EPA
Have Data2


Yes
Yes
NO
No
Yes
NO

Must Addi- Timef rame
Bibliographic tional Data For
Citation Be Submitted? Submissions


00029509 No
00029510 No
Yes
NO3
00029513 No
Yes \O

^Composition: MP = Manufacturing-use product.
2unless otherwise specified data
must be submitted no later than
six months after publication of this
 standard.

3primary Eye Irritation Studies are not required for substances which are corrosive in Primary Dermal
 Irritation Studies.  Since ethephon is corrosive, an Primary Eye Irritation Study is not required.

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                       '   F'!   80


                          SUMMARY-1

                        LABEL CONTENTS

     40 CFR 156.10 requires that certain specific  labeling
statements appear at certain locations  on the  label.   This
is referred to as format  labeling.   Specific  label items  listed
below are keyed to the table at the  end of this  Appendix.

     Item 1.  PRODUCT NAME - The name,  brand  or  trademark is
required to be located on the front  panel, preferably centered
in the upper part of the  panel.  The name of  a product will
not be accepted if it is  false or misleading.

     Item 2.  COMPANY NAME AND ADDRESS  - The  name  and address
of the registrant or distributor is  required  on  the label.
The name and address should preferably  be located  at the
bottom of the front panel or at the  end of the label text.

     Item 3.  NET CONTENTS - A net contents statement is
required on all labels or on the container of the  pesticide.
The preferred location is the bottom of the front  panel
immediately above the company" name and  address,  or at the end
of the label text.  The net contents must be  expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English  units, net contents may
be expressed in metric units.  [40 CFR  156.10(d)]

     Item 4.  EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration  No.," or "EPA
Reg. No."  The registration number must be set in  type of a
size and style similar to other print on that part of the
label on which it appears and must run  parallel  to it.  The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 156.10(e)J

    Item 5.  EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and  may appear
in any suitable location on the label or  immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through  such wrapper or container.
[40 CFR 156.10(f)]

    Item 6A. INGREDIENTS STATEMENT - An  ingredients statement
is required on the front panel.  The ingredients  statement must
contain the name and percentage by weight of  each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is  immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other  text on the panel.  It  must not be
placed in the body of other text.   [40 CFR 156.10(g)]

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                             81
                            SUMMARY-2

     Item  6B.   POUNDS PER GALLON STATEMENT - For liquid agricul-
 tural  formulations, the pounds per gallon of active ingredient
 must be indicated on the label.

     Item  7.   FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
 precautionary statements must be grouped together, preferably
 within a  block outline.  The table below shows the minimum type
 size requirements for various size labels.

     Size  of Label        Signal Word          "Keep Out of Reach
     on Front  Panel       Minimum Type Size       of Children"
     in Square Inches     All Capitals          Minimum Type Size

     5  and under                6 point              6 point
     above 5 to 10             10 point              6 point
     above 10  to 15            12 point              8 point
     above 15  to 30            14 point             10 point
     over  30                   18 point             12 point

     Item  7A.   CHILD HAZARD WARNING STATEMENT - The statement
 "Keep  Out of  Reach of Children" must be located on the front
 panel  above the signal word except where contact with children
 during distribution or use is unlikely.  [40 CFR 156.10(h)(1)(ii)]

     Item  7B.   SIGNAL WORD - The signal word (DANGER, WARNING,
 or CAUTION) is required on the front panel immediately below
 the  child hazard warning statement.  [40 CFR 156.10(h)(1)(i)]

     Item  7C.   SKULL & CROSSBONES AND WORD "POISON" - On products
 assigned  a toxicity Category I on the basis of oral, dermal,
 or inhalation  toxicity, the word "Poison" shall appear on the
 label  in  red  on a background of distinctly contrasting color and
 the skull and  crossbones shall appear in immediate proximity to
 the word  POISON.  [40 CFR 156.10(h)(1)(i)]

     Item  7D.   STATEMENT OF PRACTICAL TREATMENT - A statement
 of. practical  treatment (first aid or other) shall appear on
 the  label of  pesticide products in toxicity Categories I,
 II, and III.   [40 CFR 156.10(h)(1)(iii)]

    Item  7E.   REFERRAL STATEMENT - The statement "See Side
 (or Back) Panel for Additional Precautionary Statements" is
 required on the front panel for all products, unless all
 required  precautionary statements appear on the front panel.
 [40 CFR 156.10(h)(l)(iii)]

    Item 8.   SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary  statements listed below must appear together
on the label  under the heading "PRECAUTIONARY STATEMENTS."
The preferred  location is at the top of the side or back
panel preceding the directions for use, and it is preferred
 that these statements be surrounded by a block outline.  Each
of the three  hazard warning statements must be headed by  the
appropriate hazard title.  [40 CFR 156.10(h)(2)].

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                            82
                          SUMMARY-3

    Item 8A.  HAZARD TO HUMANS AND  DOMESTIC  ANIMALS  -  Where  a
hazard exists to humans or domestic animals, precautionary
statements are required indicating  the particular  hazard, the
route(s) of exposure and the precautions  to  be taken to  avoid
accident, injury or damage.  [40 CFR 156.10(h)(2)(i)]

    Item 8B.  ENVIRONMENTAL HAZARD  - Where a hazard  exists  to
non-target organisms excluding humans and  domestic animals,
precautionary statements are required stating the  nature of
the hazard and the appropriate precautions to avoid  potential
accident, injury, or damage.  [40 CFR 156.10(h)(2)(ii)]

    Item 8C.  PHYSICAL OR CHEMICAL  HAZARD  -  FLAMMABILITY
Precautionary statements relating to flammability  of a product
are required to appear on the label if it  meets the  criteria
in the PHYS/CHEM Labeling Appendix. The requirement  is
based on the results of the flashpoint determinations  and
flame extension tests required to be submitted for all products.
These statements are to be located  in the  side/back  panel
precautionary statements sect'ion, preceded by the  heading
"Physical/Chemical Hazards."  Note  that no signal  word is
used in conjunction with the flammability  statements.

    Item 9A.  RESTRICTED USE CLASSIFICATION - FIFRA  sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use.  Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).

    In the Registration Standard, the Agency has  (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.

    The Regulatory Position and Rationale states whether
products containing this active ingredient  are classified
for restricted use.  If they are restricted  the draft label(s)
submitted to the Agency as part of your application must
reflect this determination  (see below).

     If you do not believe that your  product  should be  classified
for restricted use, you must submit any information and
rationale with your application for reregistration.   During
the Agency's review of your application, your proposed  classi-
fication determination will be evaluated in accordance  with
the provisions of 40 CFR Part  152, Subpart  I.  You  will be
notified of the Agency's classification decision.

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                            83
                          SUMMARY-4

     Classification Labeling Requirements

     If your product has been classified for restricted use,
the following label requirements apply:

     1.  All uses restricted.

         a.  The statement "Restricted Use Pesticide" must
     appear at the top of the front panel of the label.  The
     statement must be set in type of the same minimum size
     as required for human hazard signal word (see table in 40
     CFR 156.10(h)(1)(iv)

         b.  Directly below this statement on the front panel,
     a summary statement of the terms of restriction must
     appear (including the reasons for restriction if specified
     in Section I).  If use is restricted to certified applicators,
     the following statement is required:  "For retail sale
     to and use only by Certified Applicators or persons
     under their direct supervision and only for those uses
     covered by the Certified Applicator's Certification."
                                                                *

     2.  borne but not all uses restricted.  If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:

          a.  You may label the product for Restricted use.
     If you do so, you may include on the label uses that
     are unrestricted, but you may not distinguish them
     on the label as being unrestricted.

          b.  You may delete all restricted uses from your
     label and submit draft labeling bearing only unrestricted
     uses.

          c.  You may "split" your registration, i.e., register
     two separate products with identical formulations, one
     bearing only unrestricted uses, and the other bearing
     restricted uses.  To do so, submit two applications for
     reregistration, each containing all forms and necessary
     labels.  Both applications should be submitted simul-
     taneously.  Note that the products will be assigned
     separate registration numbers.

    Item 9B.  MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with  its labeling."
This statement appears at the beginning of  the directions
for use, directly beneath the heading of that section.

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                               84
                          SUMMARY-5

    Item 10A.  REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label.  Additional worker protection statements  may be
required in accordance with PR Notice 83-2, March 29,  1983.

    Item 10B.  STORAGE AND DISPOSAL BLOCK -  All labels are
required to bear storage and disposal statements.  These
statements are developed for specific containers, sizes, and
chemical content.  These instructions must be grouped  and
appear under the heading "Storage and Disposal" in the directions
for use.  This heading must be set in the same type  sizes as
required for the child hazard warning.  Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage  and
disposal instructions appropriate for your products.

    Item IOC.  DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood  by
the average person likely to use or to supervise the use of
the pesticide.  When followed, directions must be adequate  to
protect the public from fraud and from personal injury and  to
prevent unreasonable adverse* effects on the environment.
[40 CFR 156.10]


                     COLLATERAL LABELING

    Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling.  Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product.  It
should be made part of the response to this notice and submitted
for review.

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                  SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
                                                                          CD
                                                                          en
ITEM


3
4
5
6A
6B
1
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Keg. No.
EPA Est. No.
Ingredients
statement
Pounds /gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label, text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement

Above signal
word
Immediately
below child
hazard
warning
COMMENTS

If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.

All front panel precautionary statements
must be grouped together, preferably
blocked .
Note type size requirements.
Note type size requirements.

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SIM1ARY-7
00
ON
ITEM
7C
7D
7E
6
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards 	 _
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
If II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precaut ionary
statements .
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
»

Top or side
of back panel
preceding
directions
for use
Same as above
•
Same as above
COMMENTS



Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.

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SU*IARY-8
                                                   CD
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
DPTU IT DTTlS
KJy^UlKlMJ
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
* MT^T i*m\i
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 Chapter 1—Environmental  Protection Agency


 $162.10  Labeling requirements.

   (a)  General—(1)   Contents of the label.  Every pesticide
 product shall bear a  label containing the information specified by
 the Act and t;he regulations  in this Part.  The contents of a
 label must show clearly and  prominently the following:
   (i)  The name, brand, or trademark under which the product is
 sold as prescribed in paragraph (b) of this section;
   (ii)   The name and  address of the producer, registrant, or
 person for whom produced  as  prescribed in paragraph (c) o£ this
 section;
   (iii)   The net contents as prescribed in paragraph (d) of this
 section;
   (iv)   The product registration number as prescribed in paragraph
 (e)  of  this section;
   (v)   The producing  establishment number as prescribed in para-
 graph (f)  of this section;
   (vi)   An ingredient statement as prescribed in paragraph (g)  of
 this  section;                «
   (vii)   Warning or precautionary statements as prescribed in
 paragraph (h)  of this section;
   (viii)   The  directions  for use as prescribed in paragraph (i)
 of  this  section;  and
   (ix)   The use  classification(s) as prescribed in paragraph (j)
 of  this  section.
   (2)   Prominence and legibility,  (i)  All words, statements,
 graphic  representations,  designs or other information required  on
 the  labeling by  the Act or the regulations in this part must be
 clearly  legible  to a  person with normal vision, and must be placed
 with  such  conspicuousness (as compared with other words, state-
 ments, designs,  or graphic matter on the labeling) and expressed
 in such terms  as  to render it likely to be read and understood
 by the ordinary  individual under customary conditions of purchase
 and use.
   Hi)  MI  required  label text m»>s«-»
   (A)  Be  set  in  6-point  or  larger type;
   (B)  Appear  on  a clear  contrasting background; and
   (C)  Not  be  obscured or crowded.
   (3)  Language  to be used*  All required label or labeling text
 shall appear In  the English  language.  However, the Agency may
 require or  the applicant nay propose additional text  in other
 languages as is  considered necessary to protect the public.  When
additional  text  in another language is necessary, all  labeling
 requirements will  be  applied equally to both the English and
other-language versions of the labeling.
  (4)  Placement  of Label—(i)  General.  The label shall appear
on or be securely attached to the immediate container of the

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                                  89
 pesticide product.   For  purposes  of  this  Section, and the mis-
 branding provisions of the  Act,  "securely attached" shall mean
 that a label can reasonably be expected to remain affixed during
 the foreseeable conditions  and period of  use.   If the immediate
 container is enclosed  within a wrapper or outside container
 through which the label  cannot be clearly read,  the label must
 also be securely attached to such outside wrapper or container,
 if it is a part of  the package as customarily distributed or
 sold.
   (ii)   Tank cars and  other bulk  containers—(A)  Transportation.
 While a pesticide product is in  transit,  th"e appropriate
 provisions of 49 CFR Parts  170-189,  concerning  the transportation
 of hazardous materials,  and specifically  those  provisions con-
 cerning the labeling/  marking and placarding of  hazardous materials
 and the vehicles carrying them,  define the basic Federal require-
 ments.   In addition, when any registered  pesticide product is
 transported in a tank  car,  tank  truck or  other  mobile or portable
 bulk container,  a copy of the accepted label must be attached to
 the shipping papers, and left with the consignee at the time of
 delivery.
   (B)   Storage.   When  pesticide  products  are stored in bulk
 containers,  whether mobile  or stationary, which remain in the
 custody of the user, a copy of the label  of labeling, including
 all appropriate directions  for use,  shall be securely attached  to
 the container in the immediate vicinity of the  discharge control
 valve.
   (5)   False or misleading  statements.  Pursuant to section
 2(q)(l)(A)  of the Act, a pesticide or a device  declared subject
 to  the  Act pursuant to § 162.15,  is  misbranded  if its labeling  is
 false or misleading in any  particular including both pesticidal
 and non-pesticidal  claims.   Examples of statements or representations
 in  the  labeling  which  constitute  misbranding  include:
   (i)   A false or misleading statement concerning the composition
 of  the  product;
   (ii)   A false  or  misleading statement concerning the effectiveness
 of  the  product as a pesticide or device;
   (iii)   A false or misleading statement  about  the value of  the
 pro^uc*  fo»-  purposes other  than  as a pesticide  or device?
   (iv)   A false  or  misleading comparison  with other pesticides  or
 devices;
   (v)   Any statement directly or  indirectly  implying  that  the
 pesticide  or device is recommended or endorsed  by any agency of
 the  Federal  Government;
   (vi)   The  name of a  pesticide  which contains  two or more
principal  active ingredients if  the name  suggests one or more  but
not all  such principal active ingredients even  though the  names
of  the  other ingredients are stated elsewhere  in the  labeling;
  (vii)   A true  statement used in such a  way  as to give  a  false
or misleading impression to the  purchaser;
  (viii)   Label  disclaimers which negate  or  detract  from labeling
statements  required under the Act and  these  regulations;

-------
                                   90
   (ix)  Claims as to the safety of the pesticide or its ingredients,
 including statements such as "safe," "nonpoisonous," "noninjurious,"
 "harmless" or "nontoxic to humans and pets" with or without  such
 a  qualifying phrase as "when used as directed"; and
   (x)   Non-numerical and/or comparative statements on the  safety
 of  the  product,  including but not limited to:
   (A)   "Contains all natural ingredients";
   (B)   "Among the least toxic chemicals known"
   (C)   "Pollution approved"
   (6)   Final printed labeling,  (i)  Except as provided in
 paragraph (a)(6)(ii) of this section, final printed labeling must
 be submitted and accepted prior to registration.  However, final
 printed labeling need not be submitted until draft label texts
 have been provisionally accepted by the Agency.
   (ii)  Clearly  legible reproductions or photo reductions will be
 accepted for unusual labels such as those silk-screened directly
 onco glass or metal containers or large bag or drum labels.   Such
 reproductions must be of microfilm reproduction quality.
   (b)  Name, brand, or trademark.  (1)  The name, brand, or
 trademark under which the pesticide product is sold shall appear
 on the  front panel of the label.
   (2)  No name, brand, or trademark may appear on the label which:
   (i)  Is false or misleading, or
   (ii)  Has not been approved by the Administrator through
 registration or supplemental registration as an additional name
 pursuant to S 162.6(b)(4).
   (c)  Name and address of producer, registrant, or person for
 whom produced.  An unqualified name and address given on the
 label shall be considered as the name and address of the producer.
 If the registrant's name appears on the label  and the registrant
 is not the producer, or if the name of the person for whom the
 pesticide was produced appears on the label,  it must be qualified
 by appropriate wording such as "Packed for ***," "Distributed by
 ***,"  or "Sold by ***" to show that the  name  is not that of  the
 producer.
   (d)  Net weight or measure of contents.  (1)  The net weight or
measure of content shall be exclusive of  wrappers or other
materials and shall be the average content unless explicitly
 stated as a minimum quantity.
   (2)  If the pesticide is a liquid, the  net  content statement
 shall be in terms of liquid measure at 68°F  (20°C)  and  shall  be
expressed in conventional American units  of  fluid ounces, pints,
 quarts, and gallons.
   (3)   If the pesticide is solid or semisolid, viscous  or
pressurized, or  is a mixture of liquid and solid,  the  net content
 statement shall be in terms of weight expressed as  avoirdupois
pounds and ounces.
  (4)  In all cases, net content shall be stated  in terms of  the
 largest suitable units, i.e.,  "1 pound  10 ounces"  rather than
 "26 ounces."

-------
                             r  91


   (5)  In addition to the  required  units  specified, net content
 may be expressed in metric units.
   (6)  Variation above minimum content or around an average is
 permissible only to the extent that it represents deviation
 unavoidable in good manufacturing practice.   Variation below a
 stated minimum is not permitted.  In no case  shall the average
 content of the packages in a shipment fall below the stated
 average content.
   (e)  Product registration number.   The  registration number
 assigned to the pesticide  product at the  time of registration
 shall appear on the label, preceded by the phrase "EPA Registration
 No.," or the phrase "EPA Reg.  No."   The registration number shall
 be set in type of a size and style  similar to other print on that
 part of the label on which it appears and shall run parallel to
 it.   The registration number and the required identifying phrase
 shall not appear in such a manner as to suggest or imply
 recommendation or endorsement  of the product  by the Agency.
   (f)   Producing establishments registration  number.  The producing
 establishment registration number preceded by the phrase "EPA
 Est.",  of the final establishment at which the product was produced
 may  appear in any suitable location on the label or immediate
 container.  It must appear o'n the wrapper or  outside container o£
 the  package if the  EPA establishment registration number on the
 immediate container cannot be  clearly read through such wrapper
 or container.
   (g)   Ingredient statement— (1)  General. The label of each
 pesticide product must bear a  statement which contains the name
 and  percentage by weight of each active ingredient, the total
 percentage by weight of all inert ingredients; and if the pesticide
 contains  arsenic  in any form,  a statement of  the percentages of
 total  and water-soluble arsenic calculated as elemental arsenic.
 The  active ingredients must be  designated by  the term "active
 ingredients"  and  the inert ingredients by the term "inert
 ingredients,"  or  the singular  forms of these  terms when appropriate.
 Both terms shall  be in the same type size, be aligned to  the same
 margin  and be  equally prominent.  The statement "Inert Ingredients,
 none"  is  not  required for  pesticides which contain 100 percent
 active  ingredients.   (inia«« «-he ingredient statement  is a complete
 analysis  of  the pesticide, the term "analysis" shall  not  be used
 as a heading  for  the ingredient statement.
   (2)   Position of  ingredient  statement,   (i) The ingredient
 statement is  normally required  on the front panel of  the  label.
 If there  is  an outside container or wrapper  through which the
 ingredient statement cannot be  clearly read,  the  ingredient
 statement must also appear on such  outside container  or wrapper.
 If the  size or form of the package  makes  it  impracticable to place
 the  ingredient statement on the front panel  of the  label,  permission
may  be  granted for  the ingredient statement  to appear elsewhere.
   (ii)  The  text  of the ingredient  statement  must  run parallel
with other text on  the panel on which it  appears,  and must  be
clearly distinguishable from and must not be  placed  in  the  body
of other  text.

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                                 i92
   (3)   Names to be used in ingredient statement.  The name used
 for  each  ingredient shall be the accepted common name, if there
 is one, followed by the chemical name.  The common name may be
 used alone only if it is well known.  If no common name has been
 established, the chemical name alone shall be used.  In no case
 will the  use of a trademark or proprietary name be permitted unless
 such name has been accepted as a common naraa .by the Administrator
 under  the authority of Section 25t«MB) .
   (4)   Statements of percentages.  The percentages of ingredients
 shall  be  stated in terms of weight-to-weight.  The sum of per-
 centages of the active and the inert ingredients shall be 100.
 Percentages shall not be expressed by a range of values such as
 "22-25%."  If the uses of the pesticide product are expressed as
 weight  of active ingredient per unit area, a statement of the
 weight of active ingredient per unit volume of the pesticide
 formulation shall also appear in the ingredient statement.
   (5)  Accuracy of stated percentages.  The percentages given
 shall be as precise as possible reflecting good manufacturing
 practice.  If there may be unavoidable variation between manu-
 facturing batches, the value stated for each active  ingredient
 shall be the lowest percentage which may be present.
   (6)  Deterioration.  Pesticides which change  in chemical
 composition significantly must meet the following labeling re-
 quirements:
   (i)   In cases where it is determined that a pesticide formulation
 changes chemical composition significantly, the product must bear
 the  following statement in a prominent position on the label:   "Not
 for  sale or use after [date]."
   (ii)   The product must meet all label claims  up to  the expiration
 time indicated on the label.
   (7)   Inert ingredients.  The Administrator may require the name
 of any  inert ingredient(s) to b« listed in the  ingredient statement
 if he determines that such ingredient(s) may pose a  hazard to man
 or the environment.
   (h)  Warnings and precautionary statements.   Required warnings
 and  precautionary statements concerning the general  areas of
 toxicological hazard including haxard to children, environmental
 hazard, and physical or chcxiczl hazard fall  into  two groups;  those
 required on the front panel of the  labeling and those which may
 appear elsewhere.  Specific requirements concerning  content,
placement/ type size* and prominence are given  below.
  (1)  Required front panel statements.  With the  exception  of the
child hazard warning statement,  the text required  on the  front
panel of the label is determined by the Toxicity  Category of  the
pesticide.  The category is assigned on the  basis  of the  highest
hazard shown by any of the indicators  in  the  table below:

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                             93
Hazard Indicators

Oral UD


Inhalation 1C
50


Dermal LO


Eye effects





Sktn effects



I
Up to and
1 nc 1 ud 1 ng
50 «g/kg
Up to and
Including
.2 *g/l Iter
Up to and
Including
200 «gAg
Corrosive;
corneal opacity
not reversible
•Ithln 7 days


Corrosive


TO..CI* <
II
F-cm 50 thru
500 ng/kg

Fro* .2 thru
2 mo/liter

FroM 200
thru 2000

Corneal opacity
reversible
• within 7 days;
Irritation
persisting for
7 days
Seve-e Irritation
at 72 hours

:ategor1es
1 1 1
F-am 500 thru
5000 mg/kg

F-om 2 thru
20 Mg/Mter

From 2,000 thru
20.000

No corneal opacity;
Irritation
reversible
within 7 days


Mode-ata Irritation
at 72 hou-s


IV
Greater than
5000 «gAg

Greater than
20 «ig/Mter

Greater than
20,000

No Irritation





Mild or slight
Irritation at
72 hours
   (i)  Human hazard signal word.--(A)   Toxicity  Category  I.
pesticide products meeting the criteria of  Toxicity  Category  I
shall bear on  the front  panel the  signal word  "Danger."   In
                                                             All
siieij.z uvai on tiiw iturit. yaiivt. uue aiyiiao. wutu  uanyet.   j
addition if the product was assigned to Toxicity Category  I
».w« K,^;_ ~f «fc. ^_.i  4MK»im«.<^.. «» dermal  toxicity  (as distinct
                                                             on
the basis of  its  oral,  ir.helaticr.  or
from skin and eye local effects) the word  "Poison"  shall  appear
in red on a background  of distinctly contrasting color and  the
skull and crossbones shall appear  in immediate  proximity  to the
word "poison."
              v Category II.  All  pesticide  products meet
                              II shall  bear  on  the  front  panel
  (B)  Toxicity Category  II.
criteria of Toxicity Category
the signal word "Warning."
  (C)  Toxicity Category  III.
criteria of Toxicity Category
the signal word "Caution."
  (D)  Toxicity Category  IV.
criteria of Toxicity Category
the signal word "Caution."
                               All pesticide  products  meeting  the
                              III shall bear  on  the  front  panel

                              All pesticide products meeting  the
                              IV shall bear on the  front panel

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                                94
   (E)   Use of  signal words.  Use of any signal word(s) associated
 with  a  higher  Toxicity Category is not permitted except when the
 Agency  determines  that such labeling is necessary to prevent
 unreasonable adverse effects on man or the environment.  In no
 case  shall more than one human hazard signal word appear on the
 front panel of a label.
   (ii)  Child  hazard warning.  Every pesticide product label shall
 bear  on the front  panel the statement "keep out of reach of
 children."  Only in cases where the likelihood of contact with
 children during distribution, marketing, storage or use is
 demonstrated by the applicant to be extremely remote/ or if the
 nature  of the  pesticide is such that it is approved for use on
 infants or small children, may the Administrator waive this
 requirement.
   (iii)  Statement of practical treatment—(A)  Toxicity
 Category I.  A statement of practical treatment (first aid or
 other)  shall appear on the front panel of the label of all
 pesticides falling into Toxicity Category I on the basis of oral,
 inhalation or dermal toxicity.  The Agency may, however, permit
 reasonable variations in the placement of the statement of
 practical treatment is some reference such as "See statement of
 practical treatment on back panel" appears on the front panel
 near the word "Poison* and the skull and crossbones.
   (B)  Other toxicity categories.  The statement of practical
 treatment is not required on the front panel except as described
 in paragraph (h)(1)(iii)(A) of this section.  The applicant may,
 however, include such a front panel statement at his option.
 Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph (h)(2) of this section if
 they do not appear on the front panel.
   (iv)  Placement and prominence.  All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely  to be over-
looked under customary conditions of purchase and use.  The
 following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches





Points
Required
signal word,
all capitals
6
10
12
14
18
"Keep out
of reach of
Children"
6
6
8
10
12

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                                      -•  '   95

    (2)   Other  required warnings  and  precautionary statements.   The
  warnings and  precautionary  statements  as required below shall appear
  together on  the label under the general heading "Precautionary
  Statements" and under appropriate  subheadings  of "Hazard to  Humans
  and Domestic  Animals," "Environmental  Hazard"  and "Physical  or
  Chemical Hazard."
    (i)   Hazard  to humans and domestic animals.   (A)   Where  a  hazard
  exists  to humans or  domestic animals,  precautionary  statements
  are required  indicating the particular  hazard, the route(s)  of
 exposure and  the precautions to be  taken to  avoid accident,  injury
 or  damage.   The precautionary paragraph shall  be immediately
 preceded by the appropriate hazard  signal word.
    (B)   The  following  table  depicts  typical precautionary statements.
 These statements must be modified  or expanded  to reflect specific
 hazards.
ToxicIty
category
                          Precautionary statements by toxictty category
  Oral, Inhalation, or dermal toxlctty
      Skin and eye local effect*
  1
 II
III .
Fatal (poisonous)  If swallowed (Inhaled or
 absorbed through  skin).  Oo not breath*
 vapor (dust! or spray Mist).  Do not get
 In eyes, on skin, or on clothing (Front
 panel statement of practical t-eatment
May b« fatal  If swallowed (Inhaled or
 « b so -bed through the skin!.  Oo not breathe
 va?s-$ (dust or spray mist). Oo not get In)
 eyes, on skin, or on clothing. (Appropriate)
 first aid statements required.!.         j

                                   I
Harmful  If swallowed (Inhaled or absorbed   |
 through the sktnl.  Avoid breathing vapors |
 (dust or spray •1st).  Avoid contact with  |
 sk'n (eyes or clothing). (Appropriate
 first aid statement required.).
Corrosive, causes eye and skin damage tor
 skin Irritation).  Oo not get In eyes, on
 skin, or on clothing, wear goggles or face
 shield and rubber gloves when handling.
 Harmful or fatal If swallowed.
(Appropriate first aid statement required.)


Causes *y* (and sktnl  Irritation. Do not
 get In eyes, on skin, or on clothing.
 Harmful If swallowed.  (Appropriate first
 aid statement required.I.
Avoid contact with skin, eyes or clothing.
 In case of contact Immediately flush
 •yes or skin with plenty of water.  G«t
 medical attention If Irritation persists.
                                           I
                                           I
         (No precautionary statements required.).   | (No precautionary statements required.!.
                                           I             	
   (ii)   Environmental  hazards.  Where  a hazard exists  to non-
target  organisms  excluding  humans and  domestic animals,  precautionary
statements  are required stating the nature  of the  hazard and  the
appropriate precautions to  avoid  potential  accident,  injury or

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                       P*    96
 damage.   Examples  of  the hazard statements and the circumstances
 under  which  they are  required follow:
   (A)   If a  pesticide  intended for outdoor use contains an activ
 ingredient with a  mammalian acute oral LD5Q of 100 or less, the
 statement "This Pesticide is Toxic to Wildlife" is required.
   (B)   If a  pesticide  intended for outdoor use contains an activ
 ingredient with a  fish acute LC$Q of 1 ppm or less, the statemen
 "This  Pesticide is Toxic to Fish" is reauired.
   (C)   If a  pesticide  intended for outdoor use contains an activ
 ingredient with an avian acute oral LD$Q of 100 mg/kg or less, o
 a  subacute dietary LCso of 500 ppm or less, the statement "This
 Pesticide is Toxic to Wildlife" is required.
   (D)   If either accident history or field studies demonstrate
 that use  of  the pesticide may result in fatality to birds, fish
 or mammals,  the statement "This pesticide is extremely toxic to
 wildlife  (fish)" is required.
   (E)  For uses involving foliar application to agricultural
 crops, forests, or shade trees, or for mosquito abatement
 treatments,  pesticides toxic to pollinating insects must bear
 appropriate  label cautions.
   (F)  For all outdoor uses other than aquatic applications the
 label must bear the caution "Keep out of lakes/ ponds or streams
 Do not contaminate water by cleaning of equipment or disposal of
wastes."               *
   (iii)   Physical or chemical hazards.  Warning statements-on th<
 flammability or explosive characteristics of the pesticide are
 required  as  follows:
Flash point
Required text
(A) PRESSURIZED CONTAINERS
Flash point at or below 20*F; If there Is a
flashback at any valve opening.
Flash point above 20V and net ever SO'F or If
tne flam* extension Is more than 18 In. long
at a d I stance of 6 1 n. fro* the f 1 a**.

Extremely flammable. Contents under pressure.
Keep a«ay from fire, sparks, and heated
surfaces. Do not puncture or Incinerate
container. Exposure to temperatures above
I30*F P-y c-"*" K--«»lng.
Flammable. Contents under pressure. Keep away
fro* neat, sparks, and open flame. Do not
puncture or Incinerate container. Exposure to|
temperatures above 130*F may cause bursting.
Contents under pressure. Ob net use or store
near heat or open flame. Do not punctur* or
Incinerate container. Exposure to tempera-
tures above tJO'F may cause bursting.
(B) HONPRESSURI ZED CONTAINERS



1
Extremely flammable. Keep a«ay from fire,
sparks, and heated surfaces*
Flammable. Keep away from heat and open flame.
Do not use or store near heat or open flame.

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                             -.  !   97


   (i)   Directions for Use—(1)   General  requirements—(i)  Adequacy
 and  clarity of directions.   Directions  for  use must be stated in
 terms  which can be easily  read and understood by the average
 person likely to use or to supervise  the  use of the pesticide.
 When followed, directions must be adequate  to protect the public
 from fraud and from personal  injury and  to  prevent unreasonable
 adverse  effects on the environment.
   (ii)   Placement of directions  for use.  Directions may appear
 on any portion of the label  provided  that they are conspicuous
 enough  to be easily read by  the  user  of  the pesticide product.
 Directions for use may appear on printed or graphic matter which
 accompanies the pesticide provided that:
   (A)   If required by the Agency/ such printed or graphic matter
 is securely attached to each package  of  the pesticide/ or placed
 within the outside wrapper or bag;
   (B)  The label bears a reference to the directions for use in
 accompanying leaflets or circulars/ such as "See directions in
 the  enclosed circular.* and
   (C)  The Administrator determines that  it is not necessary for
 such directions to appear on the label.
   ( i i i )   Exceptions to requirement for direction for use— (A)
 Detailed  directions for use may  be omitted  from labeling of
 pesticides which are intended for use only  by manufacturers of
 products  other than pesticide products  in their regular manu-
 facturing  processes, provided that:
   (JL)  The label clearly shows that the  product is intended for
 use  only  in manufacturing processes and  specifies the type(s) of
 products  involved.
   (2)  Adequate information such as technical data sheets or
 bulletins, is  available to the trade  specifying the type of
 product  involved and its proper  use in manufacturing processes;
   H)  The product will not  come into the hands of the general
 public except  after incorporation into  finished products; and
   M)  The Administrator determines that such directions are  not
 necessary  to prevent unreasonable adverse effects on man or the
 environment.
   (B)  Detailed directions for use may  be omitted from the  labeling
 of pesticide products Cor which  sale  is  limited to ohysicians,
 veterinarians/  or druggists/ provided that:
   U)  The label clearly states  that  the product  is for  use only
 by physicians  or veterinarians;
   (2)  The  Administrator determines that such directions are  not
 necessary  to prevent unreasonable adverse effects on man or the
environment; and
   H)  The  product is also a drug and regulated under  the  provisions
of "the Federal  Food/ Drug and Cosmetic  Act.
   (C)  Detailed directions for use may  be omitted  from  the  labeling
of pesticide products which  are  intended for  use  only  by formulators
 in preparing pesticides for  sale to the  public/ provided that:
   (1)  There is information  readily available  to  the  formulators
on t"he composition/  toxicity, methods of use/  applicable restrictions
or limitations/  and effectiveness of  the product  for  pesticide
purposes;

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                                   98
   (2)   The  label  clearly states  that the product is intended for
 use only in manufacturing,  formulating, mixing, or repacking for
 use as  a pesticide  and specifies the type(s) of pesticide products
 involved;
   (2.)   The  product  as finally manufactured, formulated, mixed, or
 repackaged  is  registered; and
   (_4)   The  Administrator determines that such directions are not
 necessary to prevent unreasonable adverse effects on man or the
 environment.
   (2)   Contents of  Directions for Use.  The directions for use
 shall  include  the following, under the headings "Directions for
 Use":
   (1)   The  statement of use classification as prescribed in
 162.10(j) immediately under the  heading "Directions for Use."
   (ii)   Immediately below the statement of use classification,
 the statement  "It is a violation of Federal law to use this
 product in  a manner inconsistent with its labeling."
   (iii)  The site(s) of application, as for example the crops,
 animals, areas, or  objects  to be treated.
   (iv)   The  target  pest(s)  associated with each site.
   (v)   The  dosage rate associated with each site and pest.
   (vi)   The  method  of application, including instructions for
 dilution, if required, and  type(s) of application apparatus or
 equipment requried.
   (vii)  The frequency and  timing of applications necessary to
 obtain  effective  results without causing unreasonable adverse
 effects  on  the environment.
   (viii)  Specific  limitations on reentry to areas where the
 pesticide has  been  applied, meeting the requirements concerning
 reentry  provided  by 40 CFR  Part  170.
   (ix)   Specific  directions concerning the storage and disposal
 of  the  pesticide  and its container, meeting the requirements of
 40  CFR  Part  165.  These instructions shall be grouped and appear
 under the heading "Storage  and Disposal."  This heading must be
 set  in  type  of the  same minimum  sizes as required  for the child
 hazard  warning (Sec Table in S 162.10(h)(1)(iv).)
   (x)   Any  limitations or restrictions on use  required  to prevent
 unreasonable adverse effects, such as:
   (A)   Required intervals between application  and  harvest of  food
 or  feed  crops.
   (B)   Rotational crop restrictions.
   (C)   Warnings as  required against use on  certain crops, animals,
 objects, or  in or adjacent  to certain areas.
   (D)   [Reserved!
   (C)   For  restricted use pesticides, a statement  that  the
 pesticide may  be  applied under the direct  supervision of a
 certified applicator who is not  physically  present at the  site of
 application  but nonetheless available  to  the  person applying the
 pesticide, unless the Agency has determined  that  the pesticide
may only be  applied under the direct  supervision of a certified
 applicator who is physically present.

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                                99
   (F)   Other pertinent  information which the Administrator
 determines to be necessary  for  the protection of man and the
 environment.
   (j)   Statement of  Use  Classification.  By October 22, 1976, all
 pesticide  products must  bear  on  their  labels a statement of use
 classification as described  in paragraphs  (j)(l) and (2) of this
 section.   Any pesticide  product  for which  some uses are classified
 for  general  use and  others  for restricted  use shall be separately
 labeled according to the labeling standards set forth  in this
 subsection,  and shall be marketed as separate products with
 different  registration numbers,  one bearing directions only for
 general use(s)  and the other  bearing directions for restricted
 use(s)  except that,  if a product has both  restricted use(s) and
 general use(s), both of  these uses may appear on a product labeled
 for  restricted use.  Such products shall be subject to the
 provisions of S 162.10(j)(2).
   (1)   General Use Classification.  Pesticide products bearing
 directions for use(s) classified general shall be labeled with
 the  exact words "General  Classification" immediately below the
 heading "Directions  for  Use."  And reference to the general
 classification  that  suggests  or  implies that the general utility.
 of the  pesticide extends beyond  those purposes and uses contained
 in the  Directions for Use will be considered a false or misleading
 statement under the  statutory definitions  of misbranding.
   (2)   Restricted Use Classification.  Pesticide products bearing
 direction for use(s) classified  restricted shall bear  statements
 of restricted  use classification on the front panel as described
 below:
   (i)   Front  panel statement  of  restricted use classification.
 (A)  At the  top of the front  panel of  the  label, set in type of
 the  same minimum sizes as required for human hazard signal words
 (see table in S  162.10(h)(1)(iv)), and appearing with  sufficient
prominence relative  to other  text and graphic material on the
 front panel  to  make  it unlikely  to be overlooked under customary
conditions of purchase and use,  the statement "Restricted Use
Pesticide" shall appear.
   (B)   Directly  below this statement on the front panel, a summary
statement of  the terms of restriction  imposed as a precondition
to registration  shall appear.  If use  is restricted to certified
applicators/  the following statement is required:  "For retail
sale to and use  only by  Certified Applicators or persons under
their direct  supervision  and  only for  those uses covered by  the
Certified Applicator's certification."  If, however, other
regulatory restrictions  are  imposed, the Administrator will  define
the appropriate  wording  for the  terms of restriction by regulation.
  (k)  Advertising.  [Reserved]


(40 PR  28268, July 3, 1975; 40 PR 32329, Aug.  1,  1975;  40  PR
38571, Aug. 21,  1975, as  amended at 43 PR  5786,  Peb.  9,  1978]

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                                100
                           PHYS/CHEM-1

                    PHYSICAL/CHEMICAL HAZARDS
Criteria
I.  Pressurized Containers

    A.  Flashpoint at or below
        20°F; or if there is a
        flashback at any valve
        opening.
    B.  Flashpoint above 208F
        and not over 80°F; or
        if the flame extension
        is more than 18 inches
        long at a distance of
        6 inches from the
        valve opening.

    C.  All Other Pressurized
        Containers
II.  Non-Pressurized Containers

    A.  Flashpoint at or below
        20°F.
    B.  Flashpoint above 20°F
        and not over 80°F.

    C.  Flashpoint over 80°F
        and not over 150°F.

    D.  Flashpoint above
        150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces.  Do not
puncture or incinerate
container.  Exposure to
temperatures above 130°F
may cause bursting.

Flammable.  Contents under
pressure.  Keep away from
heat, sparks, and flame.  Do
not puncture or incinerate
container.  Exposure to
temperatures above 130°F
may cause bursting.

Contents under pressure.
Do not use or store near
heat or open flame.  Do not
puncture or incinerate
container.  Exposure to
temperatures above  130°F
may cause bursting.
Extremely flammable.  Keep
away from fire, sparks, and
heated surfaces.

Flammable.  Keep away from
heat and open  flame.

Do not use or  store near
heat and open  flame.

None required.

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                         , -•'    1 01


                            STOR-1

             STORAGE INSTRUCTIONS FOR PESTICIDES

Heading;

All products are required to bear specific label instructions
about storage and disposal.  Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL.  Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."

Storage Instructions:

All product labels are required to have appropriate storage
instructions.  Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:

1.  Conditions of storage that might alter the composition or
    usefulness of the pesticide.  Examples could be temperature
    extremes, excessive moisture or humidity, heat, sunlight,
    friction, or contaminating substances or media.

2.  Physical requirements of storage which might adversely
    affect the container of the product and its ability to
    continue to function properly.   Requirements might include
    positioning of the container in storage, storage or damage
    due to stacking, penetration of moisture, and ability to
    withstand shock or friction.

3.  Specifications for handling the pesticide container,
    including movement of container within the storage area,
    proper opening and closing procedures (particularly for
    opened containers), and measures to minimize exposure
    while opening or closing container.

4.  Instructions on what to do if the container is damaged in
    any way, or if the pesticide is leaking or has been
    spilled, and precautions to minimize exposure if damage occurs

5.  General precautions concerning locked storage, storage in
    original container only, and separation of pesticides
    during storage to prevent cross-contamination of other
    pesticides, fertilizer, food, and feed.

6.  General storage instructions for household products should
    emphasize storage in original container and placement in
    locked storage areas.

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                                   102
                                PEST/DIS-1

                     PESTICIDE DISPOSAL INSTRUCTIONS

The label of all products, except those intended solely for domestic
use, must bear explicit instructions about  pesticide disposal.  The
statements listed beltw contain the exact wording that must appear on
the label of these products:

1.  3he labels of all products, except domestic use, must  contain the
statement, "Do not contaminate water, food, or feed by storage  or disposal."

2.  Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute  Hazardous
Wastes or are assigned to Toxicity Category I on the basis of oral or
dermal toxicity, or Toxicity Category I or II on the basis of acute
inhalation toxicity must bear the following pesticide disposal  statement:

    "Pesticide wastes are acutely hazardous.  Improper disposal of
    excess pesticide, spray mixture, or rinsate is a violation  of Federal
    Law.  If these wastes cannot be disposed of by use according to
    label instructions, contact your State Pesticide or Environmental
    Control Agency, or the Hazardous Waste representative at the nearest
    EPA Regional Office for guidance."

3.  The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous Wastes
or meet any of the criteria in 40 CFR 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:

    "Pesticide wastes are toxic.  Improper disposal of excess pesticide,
    spray mixture, or rinsate is a violation of Federal Law.  If these
    wastes cannot be disposed of by use according to label instructions,
    contact your State Pesticide or Environmental Control Agency, or the
    Hazardous Waste representative at the nearest EPA Regional  Office
    for guidance.**

4.  Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:

    "Wastes resulting from the use of this product may be disposed of on
    site or at an approved waste disposal facility."

5.  Products intended for domestic use only must bear  the  following
disposal statement:  "Securely wrap original container  in  several layers
of newspaper and discard in trash."

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                                103
                          CONT/DIS-1

               CONTAINER DISPOSAL INSTRUCTIONS

    The label of each product must bear container disposal
instructions appropriate to the type  of container.

    1.  Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, canSj jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
    2.  All other products must bear container disposal  instructions,
based on container type,listed below:
 ContainerType
 Statement
Metal
containers
(non-aerosol)
Plastic containers
<5lass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse Cor equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused!, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
  J./  Manufacturer may replace this phrase with one indicating
     whether and how fiber drum may be reused.

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                              104
                            BIBGUIDE-1

              GUIDE TO USE  OF THIS  BIBLIOGRAPHY
1.   CONTENT OF BIBLIOGRAPHY.   This  bibliography contains
    citations of all studies  considered  relevant by EPA in
    arriving at the positions and conclusions  stated  elsewhere
    in the Standard.  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, will  be  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 attempted  also 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 at any  time 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 a further explana-
    tion.  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 identifier 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
    standards of the American National Standards  Institute
    (ANSI), expanded to provide  for certain special  needs.

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                       1     105


                        BIBGUIDE-2

a.  Author.  Whenever the Agency could confidently identify
    one, 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 author.  As a last resort, the Agency has shown
    the first submitter as author.

b.  Document Date.  When the date appears as four  digits
    with no question marks, the Agency took it  directly
    from the document.  When a four-digit date  is  followed
    by a question mark, the bibliographer deduced  the
    date from evidence 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
    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 fol-
    lowing elements describing the earliest known  submission:

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

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

    (3)  Submitter.  The third element is the submitter,
         following the phrase "submitted by."  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," standing 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.
         For example, within accession number 123456, the
         first study would be 123456-A; the second, 123456-
         B; the 26th, 123456-Z; and the 27th, 123456-AA.

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                       OFFICE OF PESTICIDE PROGRAMS          ^
                    REGISTRATION STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base Supporting
                Registrations Under the Ethephon Standard
   MRID           CITATION
00009181 Atkins, E.L., Jr.; Anderson, L.D.;  Greywood,  E.A.  (1969)  Effect of
            Pesticides on Apiculture: Project No. 1499.   (Unpublished study
            received Jul 29, 1976 under 352-342; prepared by Univ. of Cali-
            fornia—Riverside, Dept. of Entomology, submitted by E.I. du
            Pont de Nemours & Co., Wilmington, Del.; CDL:224800-C)

00027493 Beavers, J.B.; Fink, R.; Brown, R.  (1978) Final Report:  Acute Oral
            LD50--Bobwhite Quail: Project No. 164-104.  (Unpublished study
            received Apr 3, 1980 under 1529-EX-2; prepared by Wildlife In-
            ternational, Ltd. in cooperation with Washington College, sub-
            mitted by GAF Corp., Chemical Div., New York, N.Y.;  CDL:
            099355-A)

00027495 Bentley, R.E. (1974) Acute Toxicity of CPGR Formulation and CPGR
            100% to Bluegill (Lepomis macrochirus) and Rainbow Trout
            (Salmo gairdneri).  (Unpublished study received Apr 3, 1980
            under 1529-EX-2; prepared by Bionomics, EG&G Environmental Con-
            sultants, submitted by GAF Corp., Chemical Div., New York, N.Y.;
            CDL:099355-D)

00029509 Griffiths, J.T.; Parent, R.A. (1979) The Approximate Acute Oral
            Toxicity (LD:50) of GAF CPD 71921/L9 in Male Sprague-Dawley
            Rats: Laboratory No. 2-6153.  (Unpublished study received Apr 3,
            1980 under 1529-EX-2; prepared by Food and Drug Research Labora-
            tories, Inc., submitted by GAF Corp., Chemical Div., New York,
            N.Y.; CDL:099356-A)

00029510 Deprospo, J.R.  (1975) Acute Dermal ID:50 Test in Rabbits: Contract
            No. 120-2544-35.  (Unpublished study received Apr 3,  1980 under
            1529-EX-2; prepared by Affiliated Medical Research, Inc., sub-
            mitted by GAF Corp., Chemical Div., New York, N.Y.; CDL:
            099356-B)

00029513 Stevens, K.R. (1979) Primary Skin Irritation Study with  Rabbits:
            Laboratory No. 6153.  (Unpublished study received Apr 3,  1980
            under 1529-EX-2; prepared by Food and Drug Research Laborato-
            ries, Inc., submitted by GAF Corp., Chemical Div., New York,
            N.Y.; CDL:099356-E)

00029515 Pope, P.K.; McCuen, P.J. (1978) Evaluation of Three Compounds  for
            Their Mutagenic Potential Utilizing the Ames Methodology: HRC
            Study No. 805875.   (Unpublished  study received Apr 3, 1980  under
            1529-EX-2; prepared by Huntingdon Research Center, submitted by
            GAF Corp., Chemical Div., New York, N.Y.; CDL:099356-G)

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                        OFFICE OF PESTICIDE PROGRAMS
                     REGISTRATION STANDARD BIBLIOGRAPHY
        Citations  Considered  to be Part of the Data Base Supporting      107
                Registrations Under the Ethephon Standard


    MRID          CITATION

 00030190 Hegidio. J.; Dyson, D.; Thomas, N.B.; et al. (1979) Residues.  In-
            cludes method dated Oct 1979.  (Unpublished study received Dec
            19, 1979 under 264-267; prepared in cooperation with Salyer Land
            Co. and  others,  submitted by Union Carbide Agricultural Products
            Co., Ambler, Pa.; CDL:099158-C)

 00032573 Harrison, S.L.; Nygren, R.E.; Gross, S.M.; et al. (1980) Residues:
            Ethrel/Sugarcane: Project No. 10223.  (Unpublished study
            received May 15, 1980 under 264-EX-59; prepared in cooperation
            with Hawaiian Sugar Planters' Association, submitted by Union
            Carbide  Agricultural Products Co., Ambler, Pa.; CDL:099427-A)

 00036500 Obenauf, G.L.  (1973) Residues: [Ethephon].   (Unpublished study re-
            ceived Mar  19, 1974 under 4F1490; prepared in cooperation with
            Greenwood Laboratories, Inc., submitted by Union Carbide Agri-
            cultural Products Co., Ambler, Pa.; CDL:093944-B)

 00038793 Union Carbide  Agricultural Products Company  (1972) Metabolism: The
            Nature and  Quantities of Residues and Metabolic Degredation
            Products Resulting from the Treatment of Walnuts with Ethephon.
            (Unpublished study received Dec 20, 1972 under 3F1344; CDL:
            093599-C)

00038795 Sibbett, S.; Hendricks, L.; Schraeder, W. (1972) Residues:
            [Ethephon].  (Unpublished study received Dec 20, 1972 under
            3F1344;  prepared in cooperation with Morse Laboratories, Inc.,
            submitted by Union Carbide Agricultural Products Co., Ambler,
            Pa.; CDL.-093599-E)

00038796 Union Carbide Agricultural Products Company  (1970) Metabolism: The
            Nature and Quantities of Residues and Metabolic Degredation
            Products Resulting from the Treatment of Filberts with Ethephon.
            (Unpublished study received Dec 20, 1972 under 3F1344; CDL:
            093599-F)

00038880 Amchem Products, Incorporated (1972) Detailed Method of Analysis
            for Residues of  (2-Chloroethyl)phosphonic acid (Ethephon) in
            Walnuts.  Method dated Nov 1972.  (Unpublished study received
            Dec 20,  1972 under 3F1344; submitted by Union Carbide Agri-
            cultural Products Co., Ambler, Pa.; CDL:093596-A)

00038881 Amchem Products, Incorporated (1972) Detailed Method of Analysis
            for Residues of  (2-Chlorethyl)phosphonic acid (Ethephon) in
            Filberts.  Method dated Nov 1972.  (Unpublished study received
            Dec 20,  1972 under 3F1344; submitted by Union Carbide Agricul-
            tural Products Co., Ambler, Pa.; CDL:093596-B)

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                       OFFICE OF PESTICIDE PROGRAMS               I  •"
                     REGISTRATION STANDARD BIBLIOGRAPHY                   \
        Citations Considered to be Part of the Data Base Supporting
                Registrations Under the Ethephon Standard


   MRID          CITATION

 00040268 Union Carbide Agricultural Products Company (19??) Effect of Tem-
            perature on the Level of Ethephon Residue in Pineapple Shell.
            (Unpublished study received Aug 27, 1971 under 2G1195; CDL:
            095928-A)

 00040269 Union Carbide Agricultural Products Company (1970) Relevance of
            Laboratory Brarming Study to a Commercial Branning Operation.
            (Unpublished study received Aug 27, 1971 under 2G1195; CDL:
            095928-B)

 00041465 Valenzuela, C.; Sarin, G.; Uribe, ?; et al. (1973) Residue: [Ethe-
            phon].   Includes method dated Oct 1973.  (Unpublished study re-
            ceived on unknown date under 4E1440; prepared in cooperation
            with Centre Agricola Valenzuela and Rorer—Hormoquimica, Ltda.,
            submitted by Union Carbide Agricultural Products Co., Ambler,
            Pa.; CDL:093839-A)

 00042977 Union Carbide Agricultural Products Company (19??) Analysis of
            Pineapple Tissue for Residues of 2-Chloroethylphosphonic acid.
            Undated method.  (Unpublished study received Dec 23, 1969 under
            264-257; CDL:100700-D)

 00047911 Westwood, M.; Anderson, J.L.; Edgerton, L.; et al. (1971) Valida-
            tion of Analytical Method.  (Unpublished study including letter
            dated Aug 4, 1971 from S.L. Harrison to Richard J. Otten, re-
            ceived Jun 16, 1971 under 1G1172; prepared in cooperation with
            Oregon State Univ. and others, submitted by Union Carbide Agri-
            cultural Products Co., Ambler, Pa.; CDL:093494-A)

00047913 Amchem Products, Incorporated (1971) Detailed Method of Analysis
            for Residues of 2-Chloroethylphosphonic acid (Ethephon) in
            Cherries.  Method dated May 1971.  (Unpublished study received
            Jun 16,  1971 under 1G1172; submitted by Union Carbide Agricul-
            tural Products Co., Ambler, Pa.; CDL:093494-C)

00053149 Amchem Products, Incorporated (1976) Detailed Method of Analysis
            for Residues of (2-Chloroethyl) phosphonic acid (Ethephon) in
            Grapes, Grape Juice, Grape Wine and Dried Grape Pomace.  Method
            dated Jul 1976.  (Unpublished study received Sep 21, 1976 under
            264-267; submitted by Union Carbide Agricultural Products Co.,
            Inc., Ambler, Pa.; CDL:095290-E)

00053150 Amchem Products, Incorporated (1976) Results of Analyses of Grapes
            for Ethephon Residues.  (Reports by various sources; unpublished
            study received Sep 21, 1976 under 264-267; submitted by Union
            Carbide Agricultural Products Co., Inc., Ambler, Pa.; CDL:
            095290-F)

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                       OFFICE OF PESTICIDt PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base Supporting
                Registrations Under the Ethephon Standard         j


   MRID           CITATION

OOU54013 Bentley, R.E. (1974) Acute Toxicity of Technical Ethrel to Grass
            Shrimp (Palaemonetes vulgaris), Mud Crab (Neopanope tex-
            ana) Water Flea (Daphnia magna), Midge Larvae (Chironomus
            tentans), and Scud (Garanarus fasciatus).  (Unpublished study
            received Dec 5, 1974 under 264-292; prepared by Bionomics,
            EG&G, Inc., submitted by Union Carbide Agricultural Products
            Co., Inc., Ambler, Pa.; CDL:230425-R)

00054018 Yamaguchi, M.; Chu, C.W.; Yang, S.F. (1971) Metabolism of Ethephon
            in Tomatoes.  (Unpublished study received Jun 7, 1972 under
            2G1195; prepared by Univ. of California—Davis, Dept. of Vege-
            table Crops, submitted by Union Carbide Agricultural Products
            Co., Inc., Ambler, Pa.; CDL:091010-B)

00054021 Union Carbide Agricultural Products Company, Incorporated (1969)
            2-Chloroethylphosphonic acid (Ethephon),1, 2-C14: Metabolism
            Study.  (Unpublished study received Jun 7, 1972 under 2G1195;
            CDL:091010-E)

00054022 Union Carbide Agricultural Products Company, Incorporated (1970)
            Residues:  [Ethrel in Pineapples].  (Reports by various sources;  •
            unpublished study received Jun 7, 1972 under 2G1195; CDL:
            091010-F)

00061717 Union Carbide Agricultural Products Company, Incorporated (1976)
            Ethephon Analyses: Ethrel: Treated Apples.  (Reports by
            various sources; unpublished study, including letter dated Aug
            11, 1976 from S.L. Harrison to W.A. Davis, received Sep 21, 1976
            under 264-267; CDL:228350-B)

00067489 Abdel-Gawad,  H.A.; Martin, G.C. (1973) The fate of 1,2-14:C-(2-
            Chloroethyl)phosphonic acid (Ethephon) in peach.  Hortscience
            8(2): 125-126.  (Also in unpublished submission received Jan 5,
            1981 under 1529-EX-2; submitted by GAF Corp., Chemical Div.,
            New York,  N.Y.; CDL:099880-E)

00077061 Sorg, R.M.; Matthews, R.J.; Naismith, R.W.  (1981) Genetic Toxicolo-
            gy: Micronucleus Test (MNT): Ethephon: Study No. PH-309A-UC-001-
            81.  (Unpublished study received Jun 24, 1981 under 264-257;
            prepared by Pharmakon Laboratories, submitted by Union Carbide
            Agricultural Products Co., Inc., Ambler, Pa.; CDL:070173-A)

00080482 Harrison, S.L. (1979) Letter sent to Warren A. Davis dated Feb 9,
            1979: Residues of Ethephon in Grapes and Related Foods and
            Feeds.  (Unpublished study received Mar 2, 1979 under 264-267;
            submitted by Union Carbide Agricultural Products Co., Inc.,
            Ambler, Pa.; CDL:097830-G)

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                       OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY                f
       Citations Considered to be Part of the Data Base Supporting        A \ 0
                Registrations Under the Ethephon Standard


   MRID           CITATION

00081782 Union Carbide Agricultural Products Company',  Incorporated  (1971)
            Residues: [Ethephon].  (Unpublished study received May  7,  1971
            under 1G1172; CDL:090971-D)

00083773 Huhtanen, K.;  Parkins, M.D.;  Heintzelman, R.W. (1981) Analysis  of
            Cow Tissues for Possible Residues of Monochloroacetic Acid.
            (Unpublished study received May 28, 1981  under 264-267;  submit-
            ted by Union Carbide Agricultural Products Co., Inc., Ambler,
            Pa.; CDL:070122-A)

00085446 Fink, R.; Beavers, J.B.; Brown, R. (1977) Final Report: Eight-day
            Dietary LC:50—Bobwhite Quail: Project No. 113-139.  (Unpub-
            lished study received Mar 2, 1979 under 264-267; prepared by
            Wildlife International, Ltd. and Washington College, submitted
            by Union Carbide Agricultural Products Co., Inc., Ambler, Pa.;
            CDL:097830-F)

00088983 Heintzelman, R.W.; Madgwick, G.G. (1981) A Review of the Metabolism. "
            of 2-Chloroethylphosphonic Acid (Ethephon): Project No. 866C51.
            (Unpublished study received Dec 22, 1981  under 264-EX-62; sub-
            mitted by Union Carbide Agricultural Products Co., Inc., Ambler,
            Pa.; CDL:070579-C)

00097422 Harrison, S.L.  (1974) Letter sent to R.J. Otten dated Mar 19, 1974:
            Metabolism of ethephon in figs.  (Unpublished study received Mar
            19, 1974 under 4F1490; submitted by Union Carbide Agricultural
            Products Co., Inc., Ambler, Pa.; CDL:093944-A)

00100515 Kelsey, W.H. (1982) Primary Eye Irritation:  [Fruit Fix Super Con-
            centrate 800]: N.V.P. Report No. X2B008.   (Unpublished study
            received Apr 19,  1982 under 5481-66; prepared by Northview
            Pacific Laboratories, Inc., submitted by Amvac Chemical Corp.,
            Los Angeles, Calif.; CDL:247314-B)

00103287 Harrison, S.; Madgwick, G. (1982) Residues of Ethephon  in Vheat,
            Barley and Oats Resulting  from Application of Ethrel as an
            Anti-lodging Agent:  File No. 30263.   (Unpublished study received
            Jun 17,  1982 under 264-376; submitted  by  Union Carbide Agricul-
            tural Products Co.,  Inc.,  Research Triangle Park,  NC; CDL:
            070929-D)

00107428 Fink, R.; Reno, F.  (1974)  Final Report:  Eight-day Dietary LC50--
            Mallard  Ducks:  [CPGR1:  Project  No. 257-102.   (Unpublished study
            received Mar 15,  1974 under 1529-20;  prepared by Truslow Farms,
            Inc., and Environmental Sciences  Corp.,  submitted by GAF Corp.,
            Chemical Div., New York, NY;  CDL:132053-A)

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                       OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY                ''til
       Citations Considered to be Part of the Data Base Supporting    -    1  ' '
                Registrations Under the Ethephon Standard


   MRID           CITATION

00108992 Fritz, D.; Barden, J.; Edgerton, L. (1971) Residues:  [Ethepon in
            Apples].  (Unpublished study received Jul 15, 1972 under 2G1217;
            prepared in cooperation with Virginia Polytechnic Institute and
            Cornell Univ., submitted by Amchem Products, Inc., Ambler, PA;
            CDL:091045-A)

00108993 Edgerton, L.; Hatch, A. (1969) Metabolism of 14C-2-Chloroethyl-
            phosphonic Acid in Apples.  (Unpublished study received Jul 15,
            1972 under 2G1217; prepared by Cornell Univ., submitted by Am-
            chem Products, Inc., Ambler, PA; CDL.-091045-B)

00116123 Amchem Products, Inc. (1970) Residue and Metabolism:  Ethephon in
            Pineapples.  (Compilation; unpublished study received Jul 30,
            1970 under 1F1016; CDL: 091065-A)

00117752 Amchem Products, Inc. (1971) [Ethephon: Residues in Walnuts,
            Grapes, and Rats].  (Compilation; unpublished study received May
            5, 1971 under 1G1167; CDL:090965-B)

00117893 Amchem Products, Inc. (1972) Metabolism and Residue Data: Ethephon
            in Cantaloupes, Grapes, Raisins.  (Compilation; unpublished
            study received Oct 7, 1972 under 2F1275; CDL:091811-A)

00118508 Chib, J.; Heintzelman, R. (1982) Ethephon, 2-Chloroethylphosphonic
            Acid, Metabolism in Lactating Goat: File No. 30388.  (Unpub-
            lished study received Dec 17, 1982 under 2F2711; submitted by
            Union Carbide Agricultural Products Co., Inc., Research Tri-
            angle Park, NC; CDL:071263-A)

00121613 Union Carbide Agricultural Products Co., Inc.  (1974)  [Ethephon
            Residue in Cranberries & Tomatoes].  (Compilation; unpublished
            study received Jul 2, 1974 under 5F1524; CDL:094038-A; 094039)

00122410 Union Carbide Agricultural Prodcts Co., Inc. (1974) Residue and
            Metabolism Data: Ethephon in Tobacco.  (Compilation; unpublished
            study received Dec 5, 1974 under 264-292; CDL:028295-A)

00122412 Sleight, B. (1971) The Acute Toxicity of Ethrel to Bluegill  ... and
            ... Salmo gairdneri.  (Unpublished study received Dec 5,  1974
            under 264-292; prepared by Bionomics, Inc., submitted by Union
            Carbide Agricultural Products Co., Inc., Research Triangle Park,
            NC; CDL:028299-B)

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                       OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY             |     '   -
       Citations Considered to be Part of the Data Base Supporting       i  <
                Registrations Under the Ethephon Standard                '  » *


   MRID           CITATION

00122423 Gross, S.; Scott, A.; Smith, T.; et al. (1978) Residues of Ethrel
            in Cotton Seed, Oil and Meal: Document No. 378A3.  (Unpublished
            study received Mar 16, 1978 under 264-EX-55; prepared in cooper-
            ation with Rio Farms and others, submitted by Union Carbide
            Agricultural Products Co., Inc., Research Triangle Park,  NC;
            CDL.-096972-B)

00122429 Interregional Research Project No. 4 (1976) The Results of Tests
            on the Amount of Ethephon Residues Remaining in or on Cucum-
            bers Including a Description of the Analytical Method Used.
            (Compilation; unpublished study received Jun 20, 1979 under
            9E2225; CDL: 098344-A)

00122433 Amchan Products, Inc. (1970) Detailed Method of Analysis for Resi-
            dues of 2-Chloroethylphosphonic Acid (Ethephon) in Pineapples.
            (Unpublished study received 1970 under 1F1016; submitted by
            Union Carbide Agricultural Products Co., Inc., Research Triangle
            Park, NC; CDL:098469-A)

00122435 Union Carbide Agricultural Products Co., Inc. (1974) [Ethephon Res-
            idue in Grapes and Related Items].  (Compilation; unpublished
            study received 1974 under 5F1524; CDL-.098573-B)

00122448 Pitcher, F. (1974) [Cepha—Daphnia magna]: Test No. 672.  (Unpub-
            lished study received Mar 13, 1974 under 1529-20; prepared by
            Pesticides Regulation Div., Animal Biology Laboratory, submitted
            by U.S. Environmental Protection Agency, Beltsville, MD; CDL:
            132055-A)

00122452 Union Carbide Agricultural Products Co., Inc. (1975) [Residues:
            Ethrel-treated Pineapples].  (Compilation; unpublished study
            received Sep 4, 1975 under 264-257; CDL-.221823-B)

00122717 Union Carbide Agricultural Products Co., Inc. (1981) The Results
            of Tests on the Amount of Ethephon Residues Remaining in or on
            Pumpkins.  (Compilation; unpublished study received Dec 21, 1982
            under 264-263; CDL:071299-A)

00123222 Union Carbide Agricultural Products Co., Inc. (1972) [Ethephon:
            Residues in Apples and Other Subjects].   (Compilation; unpub-
            lished study received Oct 24, 1972 under  3F1325; CDL:093555-B)

00123237 Union Carbide Agricultural Products Co., Inc.  (1973) Detailed
            Method of Analysis for Residues of  ... Ethephon  in Cranberries.
            (Compilation; unpublished study received  Feb  5,  1973 under
            3F1353; CDL.-093617-A)

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                       OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base Supporting
                Registrations Under the Ethephon Standard          f ;

                                                                         U3
   MRID           CITATION

00128726 Interregional Research Project No. 4 (1975) The Results of Tests
            on the Amount of Ethephon Residues Remaining in or on Macadamia
            Nuts, Including a Description of the Analytical Method Used.
            (Unpublished study received Jun 10, 1983 under 3E2909; CDL:
            071698-A)

00136287 Amchem Products, Inc. (1972) [Residues: Ethephon].  (Compilation;
            unpublished study received Oct 3, 1972 under 3F1321 ; CDL:
            092129-B)

00141506 Heintzelman, R. (1984) Ethephon Goat Metabolism: V5007.  Unpub-
            lished study prepared by Union Carbide Agricultural Products
            Co., Inc.  11 p.

00142265 Huhtanen, K. (1984) Cerone: Detailed Methods of Analysis for Resi-
            due of (2-Chloroethyl) Phosphonic Acid  (Ethephon) in Milk and
            Cow Liver, Muscle, Kidney and Fat Tissues: Project Number:
            866R10.  Unpublished study prepared by  Union Carbide Agricultur-
            al Products Co., Inc.* 20 p.

00144559 Fletcher, D. (1983) 42-Day Neurotoxitlty Study with Ethephon:Base
            250 in Mature White Leghorn Chickens: BLAL No. 83 DN  102.  Un-
            published study prepared by Bio-life Assoc., Ltd.  52 p.

00145613 Union Carbide Agricultural Products Co. (1984?) Residue  Summary:
            Ethephon Residue Data-,  Unpublished compilation.  59 p.

00165339 Huhtanen, K.; Storm, J.; Heintzelman, R. (1984) Ethrel:  Metabolism
            of Carbon 14:-ethephon in Lactating Goats: Project No. 866R10:
            File No. 32452.  Unpublished study prepared by Union  Carbide
            Agricultural Products Co., Inc.  39 p.

40632101 Interregional Research Project No. 4  (1979) The Amount of Ethephon
            Residues Remaining in or on Guava Fruit.  Prepard by  Agricultural
            Biochemistry Department, University of  Hawaii.  40 p.

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                                                                                                        114
                                                                          OMt Aporwtl No 20000*5
                  FIFHA SECTION 3(CJ(2I(8I SUMMARY SHEET
  MOOUCT NAME
                                                                                  OAT€ GUIDANCE DOCUMENT ISSUED
   With rop«i to tti« naunmtni to *rtxnit -g*>wic" di« impoird by lh« FIFflA action KCK2K8I neiKt :anumcd w m; <*»i«*c,.t,;
   Cuidtoc* document. I «m rowondmf « lfc« (allowing m«uxr
      Q I. .1 «nll •itxntl tttt m t timflT m«HMr to •taty tlM l»n««nnf rtqiufwnmti If MM MM proetdura I «M «t dcvuit !>om ia< oc not
           9«ci><*d in) ItM H*finntian Guitfdmn or itic Protocol! cont*m*4 HI RM Mopom •< £i»«fi Grouot to l*w C-Vmcjii Ctouo. OECO
           Cntmicah Ton«if Ptoonmnw. I ondooi tlM erotocolt tlt«t I will «•:
     Di. I how «i«m4 imi w
•Mfc OM or ntcra otttor r*oi«
                           •oor FIFKA
                         WtoV Mv »Wty fV«|iNo'|9d •WOtocWoV vwM M oVOMMflM !• fePA vyi
   MAMC Of OTHCP) ACCISTMAMT
     D 2. I mdooi i coniflrM "ConKiemieii •( Antmpt to £mtr Ima tn A«r«om«nt witti Otftor M*fittriMn for OfvotoarMiii •( C«n" ».ir>
          r«p«ct to in« fofltMAi 4tti nqniromoMi:
     C 4. I notion mn von omm4 mv r»»«i«io« »t ««««tin| «M «o«ow»» MM (tlw totion • wi twiioii to iw»*»
-------
                                             CMB Approval No. 2070-0057
                                             Expiration Date 11/30/89

                         GENERIC MTA EXEMPTION STATEMENT            '
                                                                          9  I *J
EPA  Product Registration Number: 	

Registrant's Name and Address:	
    As an authorized representative of the registrant of the product identified
above, I certify  that:

    (1)  I have read and am familiar with the terms of the Notice from EPA dated
              concerning a requirement for submission of generic data on the
active  ingredient	named under FIFRA Section 3(c)(2)(B).

     (2)  My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation  into the product of another product which contains that active
ingredient, vrfiich is registered under FIFRA Section 3, and vfaich is purchased by
us from another producer.
                r                   •
     (3)  An accurate Confidental Statement of Formula(CSF) for the above-identified
product is attached to this statement.  That formula statement indicates, by
company name,  registration number, and product name, the source of the subject
active  ingredient in my firm's product, or

The CSF dated	on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 8570-4.  The
registered source(s) of the above named active ingredient in my product(s) is/are
	and their registration nunber(s) is/are	  .

     (4) My firm will apply for an amendment to the registration prior to changing
the source of  the active ingredient  in our product to one that is not registered
and purchased.

     (5)  I understand, and agree on  behalf of my firm, that if at any time any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).

     (6)  I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the required generic data.  If the registrant(s) who have committed
to generate and submit the required  data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally  initiate proceedings to suspend the registrations of my  firm's
product(s) and their product(s), unless my firm commits to submit and submits
the required data in the specified time frame.  I understand that, in  such cases,
the Agency generally will not grant  a time extension  for submitting the data.

Registrant's authorized representative:
                                               (Signature)

Dated: 	             	
                                                 (Typed)

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                             PRODUCT SPECIFIC DATA REPORT
                                                             116
EPA Reg.  No.
Date
Registration Standard for
Registration
Guideline No.
Part 158
Subpart C
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test

Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol /water
partition
coefficient
pH
Test not
required
for my
product
listed
above
(check
below)

»
















I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number


















Submit-
ting
Data
(At-
tached)


















(For EPA Use Only)
MRID Numbers
Assigned


















EPA Form 8580-4

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117
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.340
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidiz ing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric "break-
down voltage

Acute oral
toxic ity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)







»








I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
















Submit-
ting
Data
(At-
tached)
















(For EPA Use Only)
MRID Numbers
Assigned







- •









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                                                                                                       118
                                        CERTIFICATION Of ATTEMPT TO ENTER
                                    INTO AN AGREEMENT WITH OTHER REGISTRANTS
                                             FOR DEVELOPMENT Of DATA
   I. I *m duly «w8lonf«d to r«ormnt tfM (oUomnaq firm(t| «wt«o «r« lubjxn to lti« r«ou«»-
     nMntt of • Netiet undtr Flf RA Section 3(c)(2l(8) conuwMd in iGu«J*nct Oocvmtnt
     IO tutxnu
                                                                                OUIOAMCC OOCUM«MT O«T«
                                                                               ACTIVf IMC«(O«M1
                                    MAMC Ot
  (Tttn 1trn\ or youo ol 1«m% n fe«fff«^ to txlow tt "my
2. My firm it «*iMwi| to dfv*«OO «nd (u«m «grt«< «o"o— "9
3.  My firn hit o>ttr(4 MI «ritiA| tt tmt« Mt« aicli »n tfrttmtni CofM t< tfM tM«n «rt Mtaetxtf. TMt tftif MM mrrociWt •«< iAtlu4«4 «n «tf«« to B«
   »*IMI« »y tn arftitriMA ««ci»«n «n4« f If MA Stniwi 3(t)(2HI)(M> if IMM! l|r*toitm •• HI ttrmt ct«M Ml M rncfMtf tt»»«t*n«  Thq tHef «M m*d«
   Id Wt lallowMf («HI(I) «n IM 
-------