r/EPA
           Unrtad StotN
           Environmental Protection
           Agancy
                           1987
            Pacticidaa ind Toxic SubcttncM
            Washington DC 20460
Guidance for the
         •
Reregistration of
Pesticide Products
Containing Propham
as the Active Ingredient

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                                     3 0 MAR 1987
          GUIDANCE FOR THE
REREGISTRATION OP PESTICIDE PRODUCTS

             CONTAINING
       THE ACTIVE INGREDIENT

              PROPHAM
             (047601)

       CAS Number  122-42-9
  ENVIRONMENTAL PROTECTION AGENCY

    OFFICE OF PESTICIDE PROGRAMS

      WASHINGTON, D.C.  20460

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              GLOSSARY OF TERMS AND ABBREVIATIONS


     The following terms are used throughout this Registration
Standard and are defined here for the convenience of the reader.

ADT: (Acceptable Daily Intake) An acceptable daily intake of
     pesticide residue based on a complete data base.

ai:    Active ingredient

CAS:  Chemical Abstract Society (number)

Core Classification:  A general guide to the acceptability of data
                      for the purpose of supporting registration
                      (invalid, supplementary, minimum, or guideline)

Core Guideline:  Studies which satisfy Agency data requirements.

Core Minimum:  Studies which are acceptable to support
               registration of pesticide products but were not
               necessarily done according to Agency guidelines.

Core Supplementary:  Studies in this category are'scientifically
                     sound, thus the information may be useful.
                     However, the studies were performed under
                     conditions that deviated substantially from
                     recommended protocols.  Studies do not
                     meet guideline requirements and thus do not
                     support registration of a product.

EEC:  Estimated environmental concentration in the environment
      (terrestrial or aquatic ecosystem).


EP:   End-use Product

EPA:  The Environmental Protection Agency, also "the Agency"

PIPRA:   The Federal Insecticide, Fungicide, and Rodenticide Act

HOT:  Highest dose tested

Invalid:  Studies which are deficient in some vital parameter
          or those studies which have been Judged not  to be
          scientifically sound or those studies whose
          reliability is seriously questioned.

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LCCQ:  (median lethal concentration):   a statistically derived
       concentration of a substance that can be expected to cause
       death in 50 percent of test animals,  expressed as-weight
       or volume of test substance per volume of air or water
       or per weight of feed (e.g., mg/L or  ppm).

LD5Q'  (median lethal dose):  a statistically derived single dose
       that can be expected to cause death in 50 percent of animals
       when administered by the route Indicated, ex-pressed as
       weight of substance per unit weight of test animal (e.g.,
       mg/kg).

MPI:  Maximum Permissible Intake

MRID:  Master Record Identification (number)—EPA's system of
       tracking studies used In support of registrations

MP:  Manufacturing-use product

NPDES:  National Pollution Discharge Elimination System

NOEL:   No Observed Effect Level—the maximum dose used in a
        test which produces no observed adverse effects.

OPP:  The Office of Pesticide Programs (EPA)

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

OM:  Organic matter (used to describe soils)

ppm:  Parts per million

PADI: (Provisional Acceptable Dally Intake)  An acceptable daily
      Intake of pesticide re.sidue based on a limited data base.

PAI:  Pure active ingredient

PGI:  Pre Grazing Interval,  a time period after pesticide
      application, specified on the products labeling,  that
      livestock are not permitted  in the  treated field  for
      grazing.

PHI:  Pre Harvest Interval, a time period after pesticide
      application, specified on the products labeling,  when
      harvest of the crop is not permitted.

PLD:  Provisional Limiting  Dose, a limiting  dose level  used
      when the available data are  insufficient  to  establish
      an ADI or PADI.  ( the lowest NOEL X a  safety factor,
      where the safety  factor is higher  than normally  used
      due to lack of confidence in the data  base  for the
      ADI or PADI calculations)

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Technical:  Active Ingredient as manufactured

TMRC: (Theoretical Maximum Residue Contribution) An estimate of
      dietary exposure obtained by multiplying residue tolerance
      levels for a given pesticide by the average dally per
      capita food consumption figure, then adding the exposure
      figures for each crop.  TMRC is usually expressed in
      terms of mg al/day, assuming a 60 kg person.

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                        TABLE OF CONTENTS

      Glossary of Terras and Acronyms

I.    Introduction
II.   Chemical(s) Covered by this Standard
        A.  Description of Chemical
        B.  Use Profile
III.  Agency Assessment 	 5
        A.  Summary
        B.  Toxicology Characteristics
        C.  Other Science Findings
        D.  Tolerance Reassessment

IV.   Regulatory Position and Rationale	11
        A.  Regulatory Positions
        B.  Criteria for Registration
        C.  Acceptable Ranges and Limits
        D.  Required Labeling

V.    Products Subject to this Standard	17

VI.   Requirement for Submission of Generic Data	19
        A.  What are generic data?
        B.  Who must submit generic data?
        C.  What generic data must be submitted?
        D.  How to comply with DCI requirements
        E.  Procedures for requesting a change in protocol
        P.  Procedures for requesting extensions of time
        G.  Existing stocks provisions upon suspension or
            cancellation

VII.  Requirement for Submission of Product-Specific Data  .  . 24

VIII. Requirement for Submission of Revised Labeling 	 25

IX.   Instructions for Submission	26
        A.  Manufacturing use products (sole active)
        B.  Manufacturing use products (multiple active)
        C.  End use products
        D.  Intrastate products
        E.  Addresses

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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 CPR 162.10 Labeling Requirements

     Physical/Chemical Hazards Labeling Statements

     Storage Instructions

     Pesticide Disposal Instructions

     Container Disposal Instructions


III.  USE INDEX APPENDIX


IV.  BIBLIOGRAPHY APPENDICES

     Guide to Bibliography

     Bibliography


V.  FORMS APPENDICES

EPA Form 8580-1   PIFRA §3(c)(2)(B) Summary Sheet

EPA Form 8580-6   Certification of Attempt to Enter Into an
                  Agreement with Other Registrants for Development
                  of Data

EPA Form 8580-4   Product Specific Data Report

EPA Form 8570-27  Generic Data Exemption Statement
                                  ii

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                       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 PIFRA.  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 FIPRA, as instructed by this Standard.
Pesticides have been grouped into use clusters and will be
reviewed on the basis of a ranking scheme giving higher
priority to (1) pesticides in clusters used on food and feed
crops; and (2) pesticides produced in large volumes.

     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 FIPRA.  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
iThe scientific reviews may be obtained  from  the  Information
 Services Section, Program Management and Support  Division
 (TS-757C), EPA, 401 M St., SW, Washington, D.C.   20460.

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active ingredient.  However, during th.e 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.

     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.  Submission 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 UO CFR Part 151*
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.

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     EPA has authority under the Data Call-in (DCI) provisions
of PIFRA 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
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information.  Registrants should notify
the Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
effects on man or the environment.  This requirement continues
as long as the products are registered by the Agency.

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II.    CHEMICAL COVERED BY THIS  STANDARD
          Description of Chemical

          Common Name

          Chemical  Name
- Propham

- Isopropyl carbanilate
          Chemical Abstracts  Service  -  122-42-9
            (CAS)  Number
          EPA Shaughnessy Number

          Empirical Formula

          Trade Name

          Physical State

          Color

          Odor

          Melting Point

          Octanol/Water Partition
            Coefficient



      B.   Use Profile

          Type of Pesticide

          Pests Controlled


          Registered Uses


          Predominant Uses


          Mode of Activity
          Formulation Types
            Registered
          Method of Application
- 047601
- Chem-Hoe, Birgin, Triherbide

- Solid

- Tan to light grey

- Faint amine-like odor

- 87 to 88 °C

- 445 i 17 over a propham
  concentration range of
  0.5 to 100 ppm (pure
  active ingredient)



- Herbicide

- Grassy weeds and some
  annual broadleaf weeds

- Terrestrial food and
  nonfood  crops

- Alfalfa, clover, sugar
  beets, and lettuce

- Inhibition of cell
  division

- Flowable concentrate  (43 and
  31 percent active  Ingredient)
  and granular  (15 percent
  active  ingredient)  formulations

- Ground  or aerial equipment

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                   III.  AGENCY ASSESSMENT

A.  Summary.  The following summarizes the results of the
    Agency's assessment of the existing scientific data base
    for propham.  A more thorough discussion of the Agency's
    assessment follows this section.

    1.  Propham has low acute oral and dermal toxlclty and
        Is classified In toxlclty Category III.  Available
        data Include a rat subchronlc toxlclty study deemed
        supplementary because of numerous deficiencies (no
        ophthalmologlc examinations were performed; analytical
        data for analysis of blended diet for stability,
        homogeneity and concentration were not presented;
        certain recommended tissues were not examined hlsto-
        logically; and several recommended blood electrolyte
        assays were not performed), and an acceptable rat
        teratology study in which the no observed effect
        level (NOEL) for developmental effects (37.6 mg/kg)
        is lower than the NOEL for maternal toxicity (375.8
        mg/kg).  A complete toxicological assessment Is not
        possible until the additional toxicology data required
        in table A of this document are submitted.

    2.  Data are Insufficient to thoroughly assess the environ-
        mental fate, Including the potential to contaminate
        ground water.  Additional data are being required.


    As a result of this review, the Agency has identified
    missing data which are essential in completing assessment
    of the environmental and human risks associated with the
    use of propham.  These data must be submitted In order  to
    maintain registrations of products or register new products
    containing propham.  Specific data requirements are listed In
    Appendix A, Tables A and B.

B.  Toxicological Assessment

    1.  Acute toxicity.  Propham has low acute oral and dermal
        toxicity and Is classified In toxicity Category III  (see
        Appendix II for discussion of toxicity categories).
        In an acute oral toxlclty study, female Sprague-Dawley
        rats were slightly more sensitive than male rats with
        respective oral LDc0 values of 2360 _+  118 mg/kg and
        3000 + 232 mg/kg.

        In an acute dermal toxicity study with rabbits, the
        acute dermal LDejg is greater than 3000 mg/kg.

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    Studies are required to establish  the  irritation
    potential of the technical material  to the  eye  and
    skin.   There are no reliable data  available with
    respect to acute inhalation toxicity;  a study  in  rats
    is required.  A subacute dermal  toxiclty study  is also
    required.

2.   Subchronic Toxiclty.  Only one subchronlc toxicity
    study  in rats is available.  In  a  90-day feeding  study,
    using  dietary levels of propham  technical of 0,  250,
    1000 and 2000 ppm,  30 rats/sex/group were assigned  to
    each of the treatment groups; 10/sex/group  were sacri-
    ficed  at the midpoint of the study (6  weeks) for  interim
    evaluation.  The NOEL was found  to be  250 ppm  (approxi-
    mately 12.5 mg/kg/day), based upon transient but  signi-
    ficant dose-related plasma chollnesterase inhibition  in
    females in the 1000 ppm and 2000 ppm groups.  Because
    of numerous deficiencies, the subchronic toxicity
    study  must be repeated in rodents.  An additional sub-
    chronic oral toxicity study, in  a  nonrodent species,
    and a  21-day dermal toxicity study are also required.

3."  Chronic and Long Term Studies

    a.  Chronic Toxiclty.  Potential effects of chronic
        exposure to propham have not been established.
        No studies are  available which meet EPA standards.
        Chronic oral toxiclty studies  are required in
        rodent and nonrodent species.

    b.  Oncogeniclty.  Sufficient data are not available
        to definitively assess the oncogenic potential  of
        propham.  The following information is available
        from studies which do not meet requirements but are
        considered to provide supplementary information:

        In a screen of   130 chemicals,  propham was adminis-
        tered (1) to newborn mice (B6C3F]. and B6AKFi strains)
        via gastric Intubation at a dose level of 215 mg/kg
        daily from 7 days to 4 weeks  (weaning), and a
        dietary concentration of 560 ppra until  termination
        at 18 months; and  (2) by a single subcutaneous
        injection to 4  week old weanling mice of both
        strains, with no further treatment  through termination
        at 18 months.   Propham was "listed among those
        compounds which did not cause a significantly  (p
      •  £ 0.01) increased  incidence of tumors in comparison
        with negative controls  in any of the major tumor
        groups studied  (i.e., hepatomas, pulmonary tumors,
        lymphomas).  However,  there was reported to be a
        significant  (p £ 0.02)  increase in  total tumors
        among orally treated animals.  In  the absence  of
        a tissue specific  Increase in tumors,  these data
        do not provide  compelling evidence  of oncogenic
        potential.

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No slgnlflcient compound-rrelated toxic effects were
found in a 2-year oncogenicity study with B6C3Fi
mice.  The test consisted of in utero exposure by
treatment of the parents with a diet containing
0, 100, 330, or 560 ppm for 16 weeks prior to
mating and through gestation and lactation.   The
weanlings were fed 0, 300, 1000, and 3000 ppm
with the high dose doubled at 62 weeks through
termination (6000 ppm).

In a study with golden hamsters fed a diet containing
2000 ppm propham for 33 months, no evidence of an
increase over control incidence of tumors was found.

Oncogenicity testing in two mammalian species (rats
and mice) is required (guideline §158.135, 83-2).

Teratogenlclty.  In a teratology study, pregnant
rats (16 to 20 per dose group) were administered
propham by gavage on days 5 through 15 of gestation
at doses of 0, 37.6, 375.8 and 1878.8 mg/kg.  The
high level tested exceeded the maximum tolerated
dose, resulting in excessive mortality.  Body weight
gain of surviving high dose dams was significantly
reduced.  Increased resorptions and dead fetuses,
as well as reduced fetal body weights, were
associated with treatment at the high dose level.
Developmental effects Including hydrocephalus,
myelomeningocele, and incomplete ossification of
the parietal and frontal bones of  the skull, were
attributable to treatment with propham at the
high dose level.  Fetuses in the mid-dose group
also showed increased incidences of incomplete
ossification of the skull.  The NOEL'S for maternal
toxiclty and developmental effects were  found to
be 375.8 and 37.6 mg/kg,- respectively. A NOEL
for fetotoxiclty was not established due to
excessive mortality of the dams at  the high  dose.

Results of a teratology  study  in mice were  incon-
clusive.  In that study, only  one  dose level  of
propham  (850 rag/kg) was  tested and  no maternal
toxiclty was reported; controls were  Inadequate;
and individual data were not  reported.   These
data do not meet minimum Agency standards,  and
are considered supplementary.

An additional  teratology  study with propham,  using
a second mammalian species  (other  than the  rat),
is required (§158.135, 83-3).

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        d. '  Reproduction.  No studies on reproductive effects
            of propham technical material are available.   A
            study Is required (§158.135, 83-4).

        e.  Mutageniclty.  No mutagenlclty tests with propham
            technical are available.   These tests are required
            (§158.135, 8l*-2, three studies).

        f.  Metabolism.  No metabolism studies are available.
            These studies are required (§158.135, 85-1).


C.  Other Science Findings

    1.  Ecological Effects.  Propham has a very low acute
        oral toxlcity to birds based on poorly designed tests,
        is slightly toxic to coldwater and warmwater fishes
        and  is moderately toxic to freshwater invertebrates.
        Additional data are required on avian oral and dietary
        toxicity.  The application of propham on registered
        use  sites is unlikely to result in an environmental
        hazard to nontarget organisms.

        No data are available on plant protection.  However,
        based on propham's use patterns (crops and fallow
        land where there Is no exposure to endangered plants)
        the  phytotoxicity data are not required.  According
        to available information, application of propham on
        registered use sites is unlikely to result in an
        environmental hazard to nontarget plants and animals.

    2.  Environmental Fate.  With the exception of an aerobic
        soil metabolism study, available data are insufficient
        to fully assess the environmental fate of, and the
        exposure of humans and nontarget organisms to, propham.
        Data are required as set forth in Table A of this
        document.

        Based on the acceptable aerobic soil metabolism study,
        ring-labeled [l^C]propham (test substance uncharacterized),
        at 2 ppm, degraded with a half-life of 7 to 1*1 days  under
        aerobic conditions In a sandy loam soil Incubated  in  the
        dark at 25 °C and 60% of water holding capacity.   By
        the  day 91 interval, 1% of the applied propham remained
        unaltered, 68.5% had been evolved as  14C02, and
        36%  was soil-bound.  Two degradates,  each < 0.02
        ppm, were Isolated from the soil but  not identified.
                                        8

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D.  Tolerance Reassessment.   Interim tolerances  have  been
    established for residues of propham in the following  raw
    agricultural commodities (40 CPR 180.319):

                                           Parts Per  Million
          Commodities                      	(ppm)	

      Hay of alfalfa, clover,                     5.0
        and grass

      Alfalfa, clover, and grass                  2.0

      Flaxseed, lentils, lettuce, peas,           0.1
        safflower seed, spinach, and
        sugar beets (roots and tops)

      Eggs; milk; and the meat, fat, and          0.05
        meat byproducts of cattle, goats,
        hogs, horses, poultry, and sheep

    EPA has evaluated the residue and toxicology data supporting
    these interim tolerances.  The results of this evaluation
    follow:

    Data gaps exist for plant and animal metabolism and for
    storage stability.  When the required data are received,
    the conclusions summarized below with respect to adequacy
    of tolerances and sufficiency of residue data are subject
    to change.  Tolerances for residues in animal commodities
    will not be assessed until the requested animal metabolism
    studies are completed and reviewed.

    The available data are not sufficient to assess the
    adequacy of interim tolerances for residues of propham in
    or on sugar beet roots, sugar beet tops,  lettuce, spinach,
    peas (succulent and dry), lentils, grass  forage, grass
    hay, alfalfa forage, alfalfa hay,  flaxseed, and safflower
    seed.  Additional data are required.

    Processing studies are required for the following commodi-
    ties: (1) dried pulp, molasses, and refined sugar from
    sugar beets; (ii) meal and hulls from flaxseed; and (111)
    meal and oil from safflower  seed.  If residues concentrate
    1n any of these processed  commodities, appropriate food/feed
    additive tolerances must be  proposed.

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Based on the current registered uses and available data,  the
registrant must: (1) propose appropriate Pregrazlng Intervals/
Preharvest Intervals (PGIs/PHIs) for clover,  lettuce,  spinach,
and sugar beets; (ii) designate propham registration for
grasses as either pasture or rangeland use,  and propose an
appropriate PGI and PHI if pasture use is designated;  (iii)
propose tolerances and provide supporting residue data for
pea vines, pea vine hay, lentil forage, lentil hay, and flax
straw; and (iv) propose that the Interim tolerances under 40
CFR 180.319 be converted to "permanent" tolerances at the
same or, if necessary, different concentrations and that
these be supported by the requested residue data.  As an
alternative to item (iii) above, the registrant may propose
feeding restrictions for pea vines, pea vine hay, and flax
straw.  If the registrant(s) does not make the required
selections, EPA will presume that residue levels remain at
day 0 levels.

The following changes must be made to commodity definitions
in the tolerance statement when permanent tolerances are
requested, and the data gaps listed in this standard are
satisfied: (i) "alfalfa" to "alfalfa forage";  (ii) "clover"
to "clover forage"; (iii) "grass" to "grass forage"; and (iv)
"peas" to "peas (succulent and dry)", in keeping with current
terminology.

The Provisional Limiting Dose  (PLD) for propham  is 0.0125
mg/kg.  This PLD is based on a 3-month rat feeding study,
with a NOEL of 12.5 mg/kg/day  (approximate conversion
from 250 ppm), and applying a  safety factor of 1000.
This is equivalent to a PLD of 0.75 mg/day for a 60 kg
individual.  The Theoretical Maximum Residue Concentration
(TMRC), based on the total tolerances listed and a daily
food intake of 1.5 kg,  is 0.0^3 mg/day, utilizing  5.7
percent of the PLD.
                                     10

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           IV.   REGULATORY POSITION AND RATIONALE
    Regulatory Positions and Rationales.   Based on review and
    evaluation of all available data and  other relevant
    information on propham, the Agency has made the following
    determinations.  Where labeling requirements are imposed,
    specific language is set out in Section D of this Chapter.

    1.  The Agency is not initiating a Special Review of
        propham at this time.

        Rationale:  Since available data  are limited, the
        Agency is not yet able to make a  determination as
        to whether any of the criteria specified in 40 CFR
            7 have been met or exceeded.
    <>.  No significant new uses* will be considered until the
        Agency has received data sufficient to thoroughly
        evaluate propham.

        Rationale;  The toxicology data base on propham is not
        sufficient to consider establishment of new significant
        tolerances.  In addition, the metabolism of propham
        in plants and animals is not adequately defined.

    3.  The Agency is requiring the following residue chemistry
        data:  plant and animal metabolism and storage stability
        studies; residue studies for sugar beet roots, sugar
        beet tops, lettuce, spinach, peas (succulent and dry),
        lentils, grass forage, grass hay, alfalfa forage, alfalfa
        hay, flaxseed, and safflower seed: and  processing studies
        to determine residues in dried pulp, molasses, and
        refined sugar from sugar beets; meal and hulls from
        flaxseed; and meal and oil from safflower seed.
        Petitions for food/feed additive tolerances will be
        required if residues concentrate.

        Rationale ;  Adequate data are not available to assess
        the adequacy of existing tolerances or to ascertain
        the need for food/feed additive tolerances in processed
        commodities.
* Significant new use is defined in M PR 27934, May 11, 1979.
  In the case of a  new food or feed use, the Agency will
  consider as significant an Increase in the Theoretical
  Maximum Residue Contribution of greater than 1 percent.
                                      11

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The Agency Is requiring the registrant to:   (1)  propose
appropriate Pre Grazing Intervals/Pre Harvest Intervals
(PGIs/PHIs) for clover, lettuce,  spinach,  and sugar
beets; (il) designate the propham registration for grasses
as either pasture or rangeland use,  and propose  an
appropriate PGI and PHI if pasture use is  designated;
and (ill) propose tolerances and  provide supporting
residue data or propose feeding restrictions for pea
vines, pea vine hay, lentil forage,  lentil hay,  and
flax straw.  These proposals must be submitted with the
revised labeling and in accordance with the timeframe
required by this document for submittal of revised
labeling or the Agency will impose appropriate feeding
restrictions, (refer to chapter IV,  D of this document,
Required Labeling)

Rationale;  Data are unavailable  to demonstrate what
PGI/PHI is needed for the cited crops in order to
assure that tolerance levels are  not exceeded.
Adequate information is not available regarding the
use for grasses and this use must be clarified and
fully supported.  There is currently no protective
mechanism (either tolerances or feeding restrictions)
to prevent excessive residues of  propham in pea vines,
pea vine hay, lentil forage, lentil hay, and flax
straw. If the requested information is not submitted,
EPA will have no alternative but to assume that day
zero residues remain on cropsand  appropriate action will
be initiated using that assumption.

The Agency is requiring the registrant to propose  that
the interim tolerances under 40 CPR 180.319 be converted
to "permanent" tolerances under a separate paragraph
of the published tolerance expressions at the same
or, if necessary, different concentrations and provide
the requested residue data to support  these  tolerances.

In addition, the registrant must propose the  following
changes to commodity definitions in the tolerance  state-
ment:  (1) "alfalfa" to "alfalfa forage";  (11)  "clover"
to "clover forage";  (ill)  "grass" to  "grass  forage";  and
(iv) "peas" to "peas (succulent and dry)".

Rationale;  Interim  tolerances were established when
petitions  for tolerances  for negligible residues  were
pending.  Since available  data do not  support the  interim
tolerances, as established, permanent  tolerances  can  not
be set based on currently  available data.   Therefore, when
data are  submitted  in  accordance with  this  document,  the
registrant must request conversion  to  permanent  tolerances,
and revise the commodity  definitions  to conform to current
terminology or  the  Agency  will propose revocation of  the
tolerances.


                              12

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 6.  The Agency Is requiring additional toxlcological data,
     as set forth in Table A of this document to assess the
     toxicity of propham.  Certain acute, subchronic, and
     chronic testing is required.

     Rationale;  These data are normally required under 40 CFR
     158 for products with propham's use patterns.   Existing
     data are insufficient to permit the Agency to  thoroughly
     assess the toxicity of propham.

 7.  The Agency is requiring additional ecological  effects
     data (see Table A) .

     Rationale;  Available data are Insufficient or lacking
     to fully assess the hazard from propham use to the avlan
     population.

 8.  The Agency is requiring environmental fate data as set
     forth in Table A.

     Rationale:  Because the requirements have not  been
     fully satisfied available data are insufficient to
     fully assess the environmental fate of propham.
     The leaching data that are available indicate  a potential
     for ground water contamination.  Hydrolysis, photo-
     degradation, metabolism, leaching, dissipation, and
     accumulation studies are required.

 9.  The Agency is not establishing a reentry interval at
     this time.

     Rationale;  Data adequate to assess the need for a
     reentry interval for field workers are not available.
     Once data are received and evaluated, the Agency will
     determine the need for such an interval.  An interim
     interval is not required because of the low acute
     toxicity demonstrated by the available data.

10.  The Agency Is requiring environmental precautionary
     labeling.

     Rationale:  The Agency's regulations (40 CFR 162.10)
     require environmental hazards labeling.  Updated
     labeling consistent with 162.10 Is required. Additional
     required labeling statements to protect wetlands are
     specified in the registration standard Section D.3.
                                   13

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   11.  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:

          §158.130  Environmental Fate

                    161-1  Hydrolysis
                    161-2,3  Photodegradation
                    163-1  Leaching and Adsorption/Desorption
                    164-1  Soil Dissipation (Field)
                    165-1  Rotational Crops (confined)
   12.  While data gaps are being filled, registered manufact-
        uring-use products (MPs) and end-use products (EPs)
        containing propham as the sole active ingredient may
        be sold, distributed, formulated and used, subject
        to the terms and conditions specified in this Standard.
        Registrants must provide or agree to develop additional
        data, as specified in the Data Appendices, in order to
        maintain existing registrations.

        Rationale;  Under FIFRA, the Agency does not normally
        cancel or withhold registration simply because data are
        missing or are inadequate (see FIFRA section 3(c)(2)(B)
        and 3(c)(7)).  The limited, available data do not
        indicate any immediate, serious concern.

        Issuance of this Standard provides a mechanism for
        identifying data needs.  These data will be reviewed
        and evaluated, after which the Agency will determine
        If additional regulatory changes are necessary.

B.  liriteria for Registration.  To be registered or reregistered
    under this Standard, products must contain propham as  the
    sole active ingredient, bear required labeling, and conform
    to the product composition, acute toxicity limits, and
    use pattern requirements listed in this section as well
    as comply with the data requirements in the attached
    3(c)(2)(b) notice.
                                       14

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C.  Acceptable Ranges and Limits

    1.  Product Composition Standard.  • To be registered  or
        reregistered under this Standard, MPs must  contain
        propham as the sole active ingredient.   Each MP
        formulation proposed for registration 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 each impurity found at greater
        than 0.1 percent.

    ?.  Acute Toxicity Limits.  The Agency will consider
        registration of technical grade and MPs containing
        propham provided that the product labeling  bears
        appropriate precautionary statements for the acute
        toxicity category in which each product is  placed.

    3.  Use Patterns.  To be registered under this  Standard,
        EPs may be labeled only for the commodities listed
        below.  The Use Index lists all registered  uses, as
        well as approved maximum application rates  and
        frequencies.

        a.  Terrestrial, nondomestic, food uses on:  sugar
            beets, lettuce, alfalfa, clovers (lidino,white,
            red, and crimson), peas (dry or green), lentils,
            safflower, and spinach.

        b.  Terrestrial, nondomestic, nonfood uses on: estab-
            lished grasses grown for seed, flax and established
            perennial grass and fallow  land, drainage ditchbanks,
            fencerows, roadsides, and lanes.

D.  Required Labeling All products must  bear appropriate
    labeling as  specified in  40 CFR 162.10.  Appendix II
    contains additional  label  requirements.

    No pesticide product  containing propham  may be  released
    for shipment by  the  registrant 4 months  after  Issuance
    of this Standard unless  the product bears  an amended  label
    which complies with  the  requirements  of  this Standard.

    No pesticide product  containing propham  may be  distributed,
    sold, offered  for sale,  held  for  sale,  shipped,  delivered
    for shipment,  or  received  and  (having so received)  delivered
    or offered  to  be delivered  by  any  person 18 months
    after issuance of this  Standard unless  the product  bears
    an amended  label which  complies with the requirements of
    this Standard.
                                     15

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In addition to the above,  the following information  must
appear on the labeling:

1.  Ingredients Statement.   The ingredient statement for
    MPs must list the active ingredient as:   isopropyl
    carbanilate.

2.  Use Pattern Statements.   All MPs must state that
    they are intended for  formulation into EPs 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  the data
    requirements in Table  A  for that use pattern.

3.  Required Precautionary  Statements All Products
        "Do not discharge effluent containing this product
        into lakes, streams,  ponds, estuaries, oceans,  or
        public waters unless  this product is specifically
        identified and addressed in an 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  EPA."

        "Do not apply directly to water or wetlands
        (swamps, bogs, marshes, and potholes).  Do not
        contaminate water by  cleaning of equipment or
        disposal of wastes."

4.   Pregrazing and Preharvest Interval Requirements

        The -registrant must:  propose appropriate PGI's/PHI's
        for clover, lettuce,  spinach, and sugar beets;
        designate the propham registration for grasses  as
        either pasture or rangeland use; propose an
        appropriate PGI and PHI if pasture use is  designated;
        propose feeding restrictions for pea vines, pea
        vine hay, lentil forage, lentil hay, and flax
        straw.  These changes must appear on the label
        as specified above or EPA will take actions
       .referred to in regulatory position number 4
        chapter IV, A of this document.
                                       16

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            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 submission 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 of 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 B2

     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 a producer who is eligible for the
formulator's 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 submission of product-specific data for
end use products at this time.  Therefore most Registration
Standards do not contain a Table C.
                                      17

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

     The data requirements listed in Table A.

C.  End 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 formulator's exemptionB,  the
     data requirements listed in Table C.

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

     1.  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:

     a.  If not eligible for the formulator's exemption,
     the date requirements listed in Tables A and C.

     b.  If eligible for the formulator's exemption, the
     data requirements listed in Table 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 formulator's 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 those
data requirements.
                                       18

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       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.1*

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 FIPRA sec.
3(cU2)(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 § 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 not now eligible for a formulator's 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 Formulator's Exemption
Statement form.

     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
^ Registrations granted after Issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.

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 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 submission 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  FIPRA 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.  What 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 datajbut will not be submitting the data
 yourself.  If you use this method, you must state who will
 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 submission.
 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 from the Registration Support and Emergency
Response Branch, Registration Division.  The request must
 include the following information:


                                      20

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     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 submissions 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.  Pile 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).

     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 PIPRA 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 PIPRA
     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
limit 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.


                                        21

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      ^.   You  request a waiver of the data requirement.  If
 you  oelieve 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.

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

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


 E.  Procedures  for requesting a change in testing protocol.

      If you will generate the required data and plan to use
 test procedures which deviate from (or are not specified in)
 either EPA's  Pesticide Assessment Guidelines or the Reports
 of Fxpert 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
 and await EPA approval, because the Agency will not ordinarily
 accept as sufficient studies using unapproved protocols.
 A request for protocol approval will not extend the timeframe
 for submission  of the data, nor will extensions generally be
 given to conduct studies due to submittal of inappropriate
 protocols.


 F.   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.  Any request for a time
 extension which is made as an Initial response to a section
 3(c)(2)(B) request notice must be submitted in writing to
 the Product Manager listed at the end of this section and
must be made before the deadline for response.  Once dates
have been committed to and EPA has accepted these commitments,
any subsequent  requests for a time extension must be submitted
                                   22

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in writing to the Office of Compliance Monitoring at the
address given in Section IX.E.

     EPA will view failure to request an extension before
the 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.   Time extensions
may be considered when Joint data development is  planned,
or when the Agency must approve a new or modified protocol
before the study can be begun.

     A request for an extension does not extend the timeframe
for submission of the data.  If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.


G.  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
PIFRA sec. 3(c)(2)(B), an existing stocks provision 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 PIFRA.
                                     23

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   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 IV.D, E, P, and G.  You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options IV.D.I. (submit data)
or IV.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.
                                   24

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    VIII.  REQUIREMENT FOR SUBMISSION 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 CPR 162.10 (see Appendix II - LABELING and SUMMARY).  In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard.  Applications submitted in response to this
notice must include draft labeling for Agency review.

     If you fail to submit revised labeling as required,
which complies with UO CPR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under PIFRA sec. 6.
                                  25

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               IX.  INSTRUCTIONS FOR SUBMISSION

A.  Manufacturing Use Products (MUPs) containing Prometryn
    as sole active ingredient.

    1.  Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:

        a.  The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
    Form 8580-1), with appropriate attachments.5

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

        c.  Formulator's Exemption Statement (EPA Form 8570-27),
    if applicable.

        d.  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 to the Product Manager:

        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.
    Labeling should 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.  The draft label 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.

        d.  Product Specific Data Report (EPA Form 8580-4).
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated In response to this notice.  This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section.  (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)


                                 26

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     3.  Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption.  If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.

B.  Manufacturing Use Products containing Prometryn
    in combination with other active ingredients.

    1.  Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:

        a.  FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
    attachments5 (EPA Form 8580-1).

        b.  Confidential Statement of Formula (EPA Form 8570-11)

       . c.  Formulator's Exemption Statement (EPA Form 8570-27),
    if applicable.

    2.  Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption.  If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.

C.  End Use Products containing Prometryn as sole
    active ingredient.

    1.  Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:

        a.  FIFRA Section 3(c)(2)(B) Summary Sheet, with
    appropriate attachments^ (SPA Form 8580-1).

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

        c.  Formulator's Exemption Statement (EPA Form 8570-27),
    if applicable.

    2.  Within 9 months from receipt of this document you
must submit to the Product Manager:

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

        b.  Product Specific Data Report (EPA Form 8580-U),
    if Table C lists required product-specific data.
                                27

-------
    c.  Three copies of draft labeling1, including the container
label and any associated supplemental labeling.  Labeling should
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.  The
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.  End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).

D.  Intrastate Products containing Prometryn either
    as sole active ingredient or in combination with other
    active ingredients.

    These products are being called in for full Federal regis-
tration.  Producers of these products are being sent a letter
instructing them how to submit an application for registration.

E.  Addresses

     The required information must be submitted to the following
address:

     Robert J. Taylor, PM-25
     Registration Division (TS-767C)
     Office of Pesticide Programs
     Environmental Protection Agency
     401 M St., SW
     Washington, D.C.  20460

     The address for submissions to the Office of Compliance
Monitoring is:

     Laboratory Data Integrity Program
     Office of Compliance Monitoring (EN-342)
     Environmental Protection Agency
     401 M St., SW
     Washington, D.C. 20460.
                                         28

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                           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 10 CPR 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
     P = Greenhouse, non-food
     G = Forestry
     H = Domestic outdoor
     I = Indoor

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

                                 29

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                           TGUIDE-2

U.  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
MRIL 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 da'ta 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.



                               30

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                                                        TABLE  A
                           GENERIC DATA REQUIREMENTS FOR THE UNREGISTERED PROPHAM TECHNICAL
Data Requirement
              Does EPA
              Have Data to
              Satisfy This   Bibliographic
Composition   Requirement?     Citation
Must Additional
Data Be Submitted     Tlmeframe
Under PIFRA Section       for
3(c)(2)(B)? I/	Submlsslon2/
§158.120 Product Chemistry

Product Identity and Composition:

61-1 - Product Identity and Disclosure     TGAI
         of Ingredients

61-2 - Description of Beginning            TGAI
         Materials and Manufacturing
         Process

61-3 - Discussion of Formation of           TGAI
         Impurities

Analysis of Product Ingredients

62-1 - Preliminary Analysis of             TGAI
         Product Samples

Physical and Chemical Characteristics
               Yes
               Partially     00145691
               Partially     00145691
               Partially     00145691
63-2 - Color
63-3 - Physical State
63-4 - Odor
TGAI
TGAI
TGAI
Yes
Yes
Yes
00145691
00145691
00145691
        Yes I/


        Yes3/



        YesV




        Yes5/
                                                                                               No

                                                                                               No

                                                                                               No
 6 months


 6 months



 6 months
12 months

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                                                        TABLE A
                          GENERIC DATA REQUIREMENTS FOR THE UNREGISTERED PROPHAM TECHNICAL
Data Requirement
Composition
§158.120 Product Chemistry (Cont'd)
Does EPA
Have Data to
Satisfy This
Requirement?

Bibliographic
Citation

Must Additional
Data Be Submitted Tlmeframe
Under PIPRA Section for
3(c)(2)(B)7 I/ Submlsslon2/


Physical and Chemical Characteristics
(Cont'd)
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Other
- Melting Point
- Boiling Point
- Density, Bulk Density, or
Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation Constant
- Octanol/Water Partition
Coefficient
- pH
- Stability
Requirements :
TGAI
TGAI
TGAI
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI

Yes
N/A6/
Partially
Partially
Partially
No
Yes
No
Partially

00145691
—
00145691
00145691
00145691
—
00145691
—
00145691

No
No
Yes?/
Yes^/
Yes9/
Yes
No
Yes
Yeslp/

—
—
6 months
6 months
6 months
6 months
—
6 months
6 months

64-1 - Submlttal of samples
                                           N/A
N/A
No
ro

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                                                         TABLE A
                            GENERIC  DATA REQUIREMENTS FOR THE UNREGISTERED PROPHAM TECHNICAL
Footnotes

 I/ For all unregistered technical or manufacturing-use products product chemistry data must be submitted  in accordance
    with §158.120.

 2/ Timeframes listed start on the issuance date of this document.

 3/ Details of the  manufacturing process,  Including the relative amounts of beginning materials, a description of the
 ~  equipment used  to produce the product, reaction conditions, the duration of each step of the process,  and purifi-
    cation procedures and quality control  measures must be submitted for each unregistered  technical.   Also, the name
    and address of  the manufacturer, producer or supplier of each beginning material used to produce the above products,
    as well as submission of a copy  of all available technical specificatlons, data sheets  and other documents in which
    the manufacturer, producer or supplier of each beginning material describes its composition and  properties must be
    submitted.

 V A discussion of each Impurity believed to be present at > 0.1 percent, based on knowledge of the beginning materials,
 ~~  all possible chemical reactions, and any contamination, Ts required for each unregistered technical.

 5/ Five or more representative samples of each technical must be analyzed for propham, each Impurity present at >^ 0.1
 ~  percent (w/w),  and each additional  "toxlcologlcally significant" impurity by analytical methods  supported by
    validation studies of their precision  and accuracy.

 6/ Not required, since the PAI is solid at room temperature.

 II Available information is inadequate because determination was performed at 30  °C,  Instead of 20  or 25 °C.

 8/ Most results were not stated quantitatively, and the temperature at which the  determinations were made was not stated.

 9/ The identity of the tested compound was not stated  (must be pure active Ingredient).

 10/ Information was not supplied concerning the effects of metals, metal  ions, normal  temperatures,  or sunlight.
   UJ

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                                                        TABLE A
                                         GENERIC DATA REQUIREMENTS FOR PROPHAM
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Tlmeframe
for
Submission 1,
§158.125 Residue  Chemistry

171-4 - Nature of Residue
          (Metabolism)

      - Plants
      - Livestock
171-4 - Residue Analytical
          Method

      - Plant residues
      - Animal residues
        Storage Stability
          Data
PAIRA
PAIRA 4 Plant
  Metabolites
TGAI 4
  Metabolites

TGAI 4
  Metabolites

PAI
Partially
Partially
Partlally5/


No


Partially
00038956, 00082681
00115^37, 00115443,
00115446, 00115447
00134707

00082676, 00091226
00091227, 00115396
00115398, 00115439
00115440, 00115441
00115442
00115448, 00119929
Yes2/
YesV
00119929
Yes6/


Yes6/7/


Yes8/
18 months3/
                                                                                                         18 Months
36 months


36 months


15 months

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                                                        TABLE A
                                         GENERIC  DATA  REQUIREMENTS FOR PROPHAM
Data Requirement
  Test
Substance
Does EPA
Have Data?
                                                                  Bibliographic
                                                                    Citation
Must Additional
  Data be
Submitted?
 Timeframe
     for
 Submission I/
§158.125 Residue Chemistry (cont'd)

171-4 - Magnitude of the Residue -
          Residue Studies for Each
          Food Use9/

      - Crop Group #1 - Root and
          Tuber Vegetables^"/

        o Crop 1 - Sugar beet roots

        - Crop Field Trials           TEP

         -- Processed Food/Feed       EP

     - Crop Group #2 - Leaves of
         Root and Tuber Vegetables1*1/

       o Crop 1 - Sugar beet tops

         — Crop field trials         TEP

     - Crop Group #3 - Leafy
         Vegetables (except Brasslca
         Vegetables) 16/

       o Crop 1 - Lettuce

         — Crop field trials         TEP
                Partially

                No
                Partially
                 Partially
                00119929
               00119929
               00119929
  Yesll/13/

  Yes12/13/
  Yesl5/
 18 Months

 24 Months
18 Months
                  18 Months
     LH

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                                                        TABLE A
                                         GENERIC DATA REQUIREMENTS FOR  PROPHAM
Data Requirement
  Test          Does EPA       Bibliographic
Substance       Have Data?       Citation
                                                                                      Must Additional
                                                                                        Data be
                                                                                      Submitted?
                                      Tlmeframe
                                         for
                                      Submission I/
§158.125 Residue Chemistry  (cont'd)

171-lJ - Magnitude of the  Residue -
          Residue Studies for Each
          Food Use

        o Crop 2 - Spinach

          — Crop field trials        TEP

      - Crop Group #4 - Legume
         • Vegetables (Succulent
          or Dried) 19/

        o Crop 1 - Lentils

          — Crop field trials         TEP

        o Crop 2 - Peas (succulent
            and dried!

          — Crop field trials       '  TEP

      - Crop Group #5 - Grass Forage,
          Fodder, and Hay

        — Crop field trials           TEP

     - Crop Group #6 - Nongrass
         Animal Feeds (Forage,
         Fodder, Straw, and Hay)237
               Partially
00119929
Yes18/
18 Months
                No
                Partially
                Partially
 00119929
 00119929
 Yes21/
 Yes22/
                                    18 Months
18 Months
18 Months
      ON

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                                                     TABLE A
                                      GENERIC DATA REQUIREMENTS FOR PROPHAM
Data
§158.
171-4
Test Does EPA Bibliographic
Requirement Substance Have Data? Citation
125 Residue Chemistry (cont'd)
- Magnitude of the Residue -
Residue Studies for Each
Food Use
o Crop 1 - Alfalfa forage
and hay
— Crop field trials TEP Partially 00119929
o'Crop 2 - Clover forage
and hay
— Crop field trials TEP Partially 00119929
- Miscellaneous Commodities
o Crop 1 - Flax
— Crop field trials TEP Partially 00119929
— Processed Food/Feed EP No
o Crop 2- Safflower
— Crop field trials TEP No
— Processed Food/Feed EP No
Meat/Milk/Poultry/Eggs TGAI or
Must Additional Tlmeframe
Data be for
Submitted? Submission I/
Yes24_/ 18 Months
No25/
Yes 267 18 Months
Yes£7/ 24 Months
Yes£8_/ 18 Months
Yes29/ 24 Months
                                     Plant  Meta-
                                     bolites      No
ReservedBO/
Osl

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                                                        TABI£ A
                                         GENERIC DATA REQUIREMENTS FOR  PROPHAM
Footnotes

I/ Timeframes listed start on the  issuance date of this document.

2/ Tne uptake, distribution, and metabolism of [^C] propham in legume forage, a  root  crop,  and a leafy vegetable
~ following soil and foliar application  (tested separately) must be Included.  The  identities and quantities of
   residue in or on mature plant parts  must be determined in order to elucidate the  terminal residues.  Residue
   identities must be confirmed by a method such as GC, HPLC, and/or mass spectrometry.   Data reflecting solvent
   extraction efficiency of propham residues must also be represented.   Representative samples from these tests must
   also be analyzed by enforcement methods to ascertain that these methods are capable of determining all metabolites
   of concern.  Depending on the results  of the requested plant metabolism studies,  additional metabolites may also be
   considered of concern in the future.

3/ Registrants are provided 18 months to  submit data commencing with the first planting season after Issuance of the
~ Standard, consistent with PR Notice  85-5.

V Metabolism studies are required utilizing ruminants, poultry, and swine in which  animals must be dosed for a
~ minimum of 3 days with [^C] propham at a level sufficient to make residue identification and quantification
   possible.  Milk and eggs must be collected twice a day during the dosing  period.   Animals must be sacrificed within 2
   hours of the final dose.  The distribution and characterization of residues must  be determined in milk, eggs, liver,
   kidney, and muscle and also skin of  hen and swine and gizzard of hen. Data reflecting solvent extraction efficiency
   of propham residues are also required. Representative samples from the above-described tests must also be analyzed
   by current enforcement methods  to ascertain the validity of these methods.

5/ The submitted analytical methods have  not been subjected to a method  trial.

6/ Residues of propham per se in or on  crop samples must be subjected to analysis under the multiresldue protocols.
~ Protocols for methods""!,""!!, III, and  IV are available from National  Technical Information Service under Order  No.
   PB 86 2C373VAS.  If the requested data regarding the nature of the residue  in plants and animals reveal additional
   metabolites of  toxicological concern,  additional analytical methods for data  collection and enforcement may be
   required.

7/ Analytical methodology must be  developed and submitted that Is suitable for  the enforcement of tolerances for
   propham in eggs, milk, and animal tissues. Also, residues of propham  per  s£ in or on crop samples must be subjected
   to analysis by  the multiresldue protocols.  Protocols for methods  I,II,III, and IV are avialable from NTIS under
   order no.  PB 86 20373 VAS.

8/ The storage Intervals and conditions must be reported for all samples used to support tolerances for residues of
   propham in or on raw agricultural commodities  and in processed commodities.   These data must be accompanied by  data
   depicting the decline of residues during  the Intervals and under  the  conditions specified.  On receipt of these data,
    the adequacy of the tolerances can  be  reevaluated.  Residue data  requested in this Standard must be accompanied by

CM
CD

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                                                         TABLE A
                                          GENERIC DATA REQUIREMENTS FOR PROPHAM
 Footnotes (cont'd)

    Information describing the storage conditions and Intervals for all samples analyzed.  These data must be accompanied
    by fortification  recovery data depicting the stability of residues of concern in appropriate sample substrates  under
    the storage conditions and for the time Intervals specified.  Any samples collected in the future must be stored at
    a temperature  shown  to reduce the loss of propham upon storage of treated samples; a temperature < 0 °C appears to
    be necessary.  An acceptable analytical method must be used for analysis (see Residue Analytical Methods section).
    The method must Include maceration of the sample, i.e., not merely surface washing.  If the requested metabolism data
    indicate the presence of additional residues of toxicologlcal concern, data depleting the storage stability  of  such
    residues will  be  required.

 £/ It should be noted that the conclusions stated below are subject to change on receipt of the requested plant
    metabolism and storage stability data.  Also, the crop group conclusions stated below address only the minimum
    residue chemistry data base acceptable for purposes of establishing a group tolerance.  The registrant should con-
    sider the data requirements stated in 40 CFR 180.3^ to propose group tolerances.

1Q/ The available  data are Insufficient to determine whether a group tolerance is appropriate.  If the registrant seeks
    a crop group tolerance, additional data are required to support the established tolerance for residues of propham
    In or on the representative group member sugar beet roots (refer to the "Sugar beet roots" section for details  of
    data requirements).  Use directions must be proposed, and appropriate supporting residue data submitted for  the
    additional representative group members carrots, potatoes, and radishes.

ll/ The following  data are required, in conjunction with data required for sugar beet tops:

    o  Data depicting propham residues of concern in or on sugar beet roots harvested at the established PHI after
       postemergence  application of, in separate tests, the 4 Ib/a.i./gal F1C formulation at 6 Ib ai/A as a directed
       shielded spray and the 15% active ingredient G formulation at 5.25 Ib al/A by ground or air equipment.  Tests
       must be conducted In CA(23%), ID(15%), and MN(20%) or ND(10%) which represent 68% of U.S. sugar beet production
       (Agricultural  Statistics, 1985, p. 76).

    o  Data depicting propham residues of concern In or on sugar beet roots harvested at the established PHI after
       postemergence  application of the M Ib/a.i./gal F1C formulation at H Ib ai/A by air and through center pivot
       sprinkler Irrigation (in separate tests).  Tests must be conducted In ID, OR, or WA since this use Is  limited
       to these States.
   Osl

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                                                         TABLE A
                                          GENERIC'DATA REQUIREMENTS FOR PROPHAM
 Footnotes  (cont'd)

    o  Data depicting propham residues of concern In or on sugar beet roots harvested at the established  PHI  following
       postemergence application, In the irrigation water, of the U Ib/a.i./gal F1C formulation at 6  Ib al/A.   Tests must
       be conducted In CA.  Alternatively, the registrant may elect to cancel the Irrigation water use permitted In
       CA under  SLN CA-780196.

12/ Data from a  processing study depicting propham residues of concern in dehydrated pulp, molasses,  and  refined
    sugar processed from sugar beet roots bearing measurable weathered residues.  If residues concentrate In  any of
    these processed commodities, appropriate food and/or feed additive tolerances must be proposed.

13/ The registrant must also propose a label revision establishing an appropriate PHI.  The data requested above
    (see footnotes 11 and 12) must reflect this revision or the Agency will impose an interval.

IV The available data are Insufficient to determine whether a group tolerance is appropriate.  If the registrant
    seeks a crop group tolerance, additional data are required to support the established tolerance for  residues
    of prcJpham in or on the representative group member sugar beet tops (refer to the "Sugar beet tops"  section
    for details  of data requirements).  Use directions must be proposed, and appropriate supporting residue data
    submitted for the additional representative group member turnip tops.

15/ The following data are required, in conjunction with data required for sugar beet roots:

    o  Data depicting propham residues of concern In or on sugar beet tops harvested at the established  PHI after
       postemergence application of, in separate tests, the ^ Ib/a.i./gal FIG formulation at 6 Ib al/A as a directed,
       shielded  spray and the 15% a.i. G formulation at 5-25 Ib ai/A by ground and air equipment.  Tests  must be
       conducted in CA(23£), ID(15/0, and MN(20%) or ND(10%), which represent 68% of U.S. sugar beet  production
       (Agricultural Statistics, 1985, p. 76).

    o  Data depicting propham residues of concern In or on sugar beet tops harvested after postemergence application of
       the  ^ Ib/a.l./gal F1C formulation at H Ib al/A by air and through center pivot sprinkler Irrigation (in separate
       tests).  Tests must be conducted In ID, OR, or WA since this use is limited to these States.

    o  Data depicting propham residues of concern in or on sugar beet tops harvested at the established  PHI following
       postemergence application in irrigation water of the J| Ib/a.i./gal FIG formulation at 6 Ib ai/A.   Tests must be
       conducted in CA.  Alternatively, the registrant may elect to cancel the Irrigation water use permittee] In CA
       under SLN CA-780196.   '

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                                                         TABLE A
                                        GENERIC DATA REQUIREMENTS FOR PROPHAM
 Footnotes (cont'd)

    o  The registrant must also propose a label revision establishing an appropriate PHI.  The data requested above
       must reflect  this  revision.

16/ Tne available data  are insufficient to determine whether a group tolerance is appropriate.  If the  registrant
    seeks a crop group  tolerance, additional data are required to support the established tolerance for residues
    of propham in or on the  representative group members lettuce and spinach (refer to the "Lettuce" and "Spinach"
    sections for details  of  data requirements).  Use directions must be proposer!, and appropriate supporting residue
    data submitted for  one additional representative group member (celery) or data supporting each crop will be required.

17/ Data must be submitted depicting the residues of propham in or on lettuce (with and without wrapper leaves
    attached) harvested at the proposed PHI following postemergence direct shielded application of the  4 Ib/a.l./gal
    F1C fomulation at 6 Ib al/A.  Tests must be conducted in the States of CA(73%) and AZ(17%) representing 90% of
    corrmercial U.S.  lettuce  production (Agricultural Statistics, 1985, p. 159).  The registrant must propose a label
    revision establishing an appropriate PHI for the postemergence application or the Agency will set the PHI.  The
    data requested above  mustreflect this revision.

18/ Data must be submitted depicting the residues of propham in or on spinach harvested at the proposer! PHI following
    postemergence application of the *J Ib/a.i./gal FIG formulation at 5 Ib ai/A.  Tests must be conducted In CA(21%),
    and OK (6%) or TX(25%),  representing 55% of the commercial U.S. 1982 spinach acreage  (1982 Census of Agriculture,
    Vol. 1, Part 51, p. 352).  The registrant must propose revision of the label to establish an appropriate PHI for the
    postemergence application.  The data requested above must reflect this proposed PHI.  Residue data  will not be
    required for spinach  grown for seed unless all other uses on spinach are cancelled.

19_/ The available data  are insufficient to determine whether a group tolerance is appropriate.  If the  registrant
    seeks a crop group  tolerance, additional data are required to support the existing tolerance for  residues of propham
    in or on succulent  and dried peas (see "Peas" section for details).  The registered use pattern for peas (preplant
    and postemergence)  is different from that  for lentils (preplant).  Use directions must be proposed  and appropriate
    supporting residue  data  submitted for beans (Phaseolus spp.; one succulent variety and one dried  variety) and
    soybeans.

20/ Data depicting the  residues of propham in or on lentils harvested at normal crop maturity following preplant
    incbrporated application of the 4 Ib/a.i./gal F1C formulation by ground equipment at  4 Ib ai/A must be submitted.
    Tests must be conducted  In  ID(31%) or WA(66%), which  represent 97% of U.S. lentil production  (1982  Census of
    Agriculture, Vol.  1,  Part 51, p. 320).  Since lentil  forage and lentil hay are raw agricultural commodities, the
    registrant must  propose  tolerances and submit appropriate supporting residue data.

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                                                        TABIE A
                                         GENERIC DATA REQUIREMENTS FOR PROPHAM
Footnotes (cont'd)

21 / Data depicting  propham residues of concern in or on pea seed (succulent peas plus pods, and dry) harvested at the
    proposed PHI following postemergence broadcast application (by ground or aerial equipment) of the  15% a.i. G
    formula at U Ib ai/A must be submitted.  Succulent and dry varieties must be represented In separate  tests.  Tests
    must be conducted  in MN(21%) or WT(26%) and OR(10%) or WA(22%) which represent 79% of U.S. pea production
    (Agricultural Statistics, 1985, p. 162).  The registrant must propose a PHI which Is reflected by  the data
    requested above.  Since pea vines and pea vine hay are raw agricultural commodities, the registrant must propose
    tolerances and  submit appropriate supporting residue data.  Alternatively, the registrant may elect to propose
    feeding restrictions for pea vines and pea vine hay.

22/ Data depicting  propham residues of concern In or on grass forage and hay from three species Including:
    (1) Kentucky bluegrass; (11) Chewing's fescue, creeping red fescue or tall fescue; and (111) orchardgrass , per-
    ennial ryegrass or bentgrass (Astoria/Highland) must be submitted.  Grass forage In the various tests must be
    harvested 0 days after application (using ground equipment) of the 4 Ib/a.i./gal F1C formulation at 4 Ib ai/A.  Hay
    should be harvested at the normal harvest tlme(s).  Tests must be conducted in OR.  Residue data will not be
    required for grass grown for seed unless all other grass uses are cancelled.  The registrant must  also propose a
    label revision  designating propham use for either pasture (fenced, controlled grazing areas) or range (unfenced,
    grazing not controlled) grasses.  If pasture use is designate'], the registrant must propose an appropriate PGI and
    FHI (or delete  the use patterns) after which grazing and harvesting of treated grass is restricted; the data request
    above must reflect that FHI.  Alternatively, other specific label directions/limitations may preclude the need for
    a PGI and/or a  PHI or we will assume that residues at any time are equal to residues at 0 day.

23/ A crop group tolerance is not appropriate for the nongrass animal feeds group at this time because additional
    data are needed to support the established tolerances for residues of propham in or on alfalfa and clover (see
    individual crop sections for details).

2V Data depicting  residues of propham in or on alfalfa forage and hay harvested 50 days after postemergence broadcas
    application of, in separate tests, the ^ Ib/a.l./gal FIG formulation In 20 gal water/A and the 15% a.l. G
    formulation at  5 Ib al/A must be submitted.  Ground and aerial applications must be represented in separate tests.
    Tests must be conducted In CA(7%), ID(5%) or MT(W, IA(7%) or MN(7%), KS(W or NE(6%), ND(3%) or SD(6%), and
    WI(13%), which  represent 62% of the U.S. alfalfa production (Agricultural Statistics 1985, p. 2^2).   Note that
    residup data will  not be required for alfalfa grown for seed unless all other uses on alfalfa are  cancelled; If
    needed in the future, such data will be translated to clover.  Data depleting residues In alfalfa  forage and hay
    harvested 50 days  following the postemergence broadcast application of, In separate tests, the 4 Ib/a.i./gal FIG
    in 20 gal water/A  and the 15% a.l. G at 6 Ib ai/A must be submitted.  Ground and aerial applications  must be represe
    in separated tests.  Tests must be conducted In CA, ID, NV, OR, and WA.  Alternatively, the registrant may elect
     ro

-------
                                                        TABLE A
                                         GENERIC DATA REQUIREMENTS FOR PROPHAM
Footnotes (cont'd)

    to cancel this postemergence  broadcast use permitted In CA under SLNs CA-780057 and CA-780058,  In ID under SIM
    ID-830006, in NV under SLNs NV-780002 and NV-780003, in OR under OR-830005, and in WA under  SLN WA-830002.  Data
    depicting residues in or on alfalfa  forage and hay harvested 8 days following postemergence  broadcast application
    of the 4 Ib/a.l./gal F1C formulation at  4 Ib al/A by center pivot sprinkler irrigation In  0.5-1.0 Inch water must
    be submitted.  The tests must be  conducted In ID, OR and WA.  Alternatively, the registrant  may elect to cancel
    this postemergence broadcast  use  permitted in ID under SLN ID-830006, in OR under SLNs OR-770015 and OR-830005, and
    in WA under SLNs WA-770003 and WA 830002.  Data depicting residues in or on alfalfa forage and  hay harvested 50
    days following the application of the 1  Ib/ a.l./gal PIC formulation at ^ Ib ai/A in irrigation water.  Tests must
    be conducted in CA.  Alternatively,  the  registrant may choose to cancel this irrigation water use permitted under
    SLN CA-780211.

25/ The submitted data are Insufficient  to assess the adequacy of the tolerances for residues' of propham In or on
    clover and clover hay because data were  not submitted for field dried hay samples and geographic representation of
    the acceptable data was inadequate.  Residues of 530-1061 ppm were found In or on clover  forage samples harvested
    at the implied PGI/PHI of 0 days  from two OR tests treated at 1.5X the maximum registered  use rate.  Nevertheless,
    no additional data will be specifically  required for clover because the data requested for alfalfa can be
    translated to support the clover  tolerances since the uses are similar.  However, the registrant must propose label
    revisions establishing a realistic PGI and/or PHI, and data translated from alfalfa must  reflect this revision.
    Alternatively, other specific label  directions/restrictions may obviate the need for a PGI and/or PHI.  The
    transit*ted data cannot be used to support a crop group tolerance.

26/ Data depicting propham residues of concern In or on flaxseed harvested at normal crop maturity  following
    postemergence broadcast application  of the 15% a.l. G formulation by ground or aerial equipment at 4 Ib ai/A when
    the crop is 2-4 Inches high must  be  submitted.  Tests must be conducted In MN(9%), ND(69%),  or  SD(21%) which
    represent 100% of U.S. flaxseed production (Agricultural Statistics, 1985, p.  113).  Since flax straw Is a raw
    agricultural commodity, the registrant must propose a tolerance and provide appropriate supporting residue data.
    Alternatively, the registrant may propose label revisions restricting the feeding of flax straw to livestock.

27/ Data from a processing study  depicting propham residues of concern In meal and hulls processed  from flaxseed
    bearing measurable weathered  propham residues must be submitted.  If residues, concent rate in either of these com-
    modities appropriate feed additive tolerances must be proposed.

28/ Data depicting propham residues of concern in or on safflower seed harvested at normal crop  maturity following
    preplant Incorporated or preemergence application of the 4 Ib/a.l./gal PIC formulation at 4  Ib  al/A must be
    submitted.  Tests must be conducted  In CA(76%) and MT(17%), which represent 93% of U.S. safflower production
    (1982 Census of Agriculture,  Vol. 1, Part 51, p. 317).

-------
                                                        TABLE A
                                         GENERIC DATA REQUIREMENTS FOR PROPHAM
Footnotes (cont'd)

29/ Data from a processing study depicting propham residues of concern in meal and oil processed from  safflower seed
    bearing measurable weathered residues must be submitted.  If residues concentrate in either of  the processed com-
    modities appropriate  food and/or feed additive tolerances must be proposed.

30/ Due to Inadequate  understanding of plant metabolism of propham and the lack of established residue tolerances for
    several feed commodities which can contribute to the diets of livestock species, the interim tolerances for animal
    canmodi»;ies cannot be assessed and dietary intake levels for animal feed studies cannot be determined.   When a
    theoretical maximum dietary intake level for propham can be accurately estimated, appropriate feeding studies will
    be required.  Also, the metabolism of propham in animals is not adequately understood (see "Nature of the Residue
    In Animals" section for details).  Therefore, if the required metabolism studies reveal other residues of concern,
    additional residue data will be required from any required feeding studies.

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                                                         TABLE A
                                           GENERIC DATA REQUIREMENTS FOR PROPHAM
Data Requirement
    Test
 Substance
  Use
Patterns
                            Must Additional     Tljneframe
Does EPA     Bibliographic       Data be             for
Have Data?   Citation          Submitted?	Submission I/
§158.130 Environmental Fate

DEGRADATION STUDIES-LAB;

161-1 - Hydrolysis

Photodegradation

161-2 - In Water

161-3 On Soil

161-1 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
        Adsorptlon/Desorptlon

163-2 - Volatility (Lab)

163-3 - Volatility (Field)
TGAI or PAIRA
TGAI or PAIRA

TGAI or PAIRA

TGAI or PAIRA

TGAI or PAIRA
TGAI or PAIRA

TEP

TEP
  A,B
TGAI or PAIRA     A,B

TGAI or PAIRA     A

TGAI or PAIRA     A
  A,B

  A

  NA3/

  NA3/
  A

  A
   No



   No

   No

   No



   Yes

   No
   No

   No

   No
                   Yes
00115^70
No

Yes
                   Yes

                   ReservedV

                   Reserved1*/
               9 Months
                                                Yes             9 Months

                                                Yes             9 Months

                                                Reserved^/
                                  27 Months
                                                               12 Months
    en

-------
                                                          TABLE A
                                           GENERIC  DATA REQUIREMENTS FOR PROPHAM
Data Requirement
§158.130 Environmental Fate (cont
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
Test
Substance
'd)
TEP
TEP
TEP

TEP
PAIRA
TEP
Use
Patterns
A
N/A3/
N/A3/

A
A
A
Must Additional
Does EPA Bibliographic Data be
Have Data? Citation Submitted?
No - Yes



No - Reserved/
No - Yes
No - Reserved^/
Tlmeframe
for
Submlssionl/
27 Months




39 Months

          (Field)

165-3 - Irrigated Crops

165-4 - In Fish

165-5 - In Aquatic Nontarget
          Organisms
TEP
N/A3/
TGAI or PAIRA   A,B
           No
TEP
N/A3/
Yes
12 Months

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                                                         TABLE A
                                           GENERIC DATA REQUIREMENTS FOR PROPHAM


Footnotes

I/ Tlmeframes listed start on the issuance date of this document.

2/ Pending results of laboratory volatility data and  review of reentry  Issues.   These studies will be required If the
~  chemical is volitile or use patterns/data warrant  a reentry interval.

3/ No aquatic and forestry use pattern.  These studies will  be required  if these use patterns are requested.

V Pending reentry issues.  These studies will be required  if the  use patterns  warrant the establishment of a reentry
~~  interval.

5/ Pending results of field dissipation  study.  These studies will be required  If the chemical Is long lived In  the soil.

6/ Pending results of confined rotational crop study. This field  study will be required If the confined study shows
   uptake by rotational crops.

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                                                         TABLE A
                                          GENERIC DATA REQUIREMENTS FOR PROPHAM


Data Requirement
§158.1110 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
Patterns

A
A
A
A

Does EPA Bibliographic
Have Data? Citation

No
No
No
No
Must Additional
Data be
Submitted?

Conditional V
No£/
Optional^/
Optional 3/
_!/ Pending further toxlcological  evaluation when used as a post emergent herbicide.

2/ Soil Dissipation data are required  only for uses where workers will be exposed  directly to substantial quantities  of
~  soil during their work,  e.g.,  for use on potatoes or peanuts where hand  harvesting will be performed.

3_/ Human-exposure monitoring data may  be submitted at the registrant's option.   If Dermal Exposure data are submitted,
   Inhalation Exposure data must  also  be submitted.
          CO

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                        TABLE A
         GENERIC DATA REQUIREMENTS FOR PROPHAM
Data
§158.
AVIAN
71-1
71-2
71-3
71-4
Requirement
145 Wildlife and Aquatic
AND MAMMALIAN TESTING
- Avian Oral LDrjQ
- Avian Dietary LCejQ
- Wild Mammal Toxlcity
- Avian Reproduction
Composition
Organisms
TGAI
TGAI
TGAI
TGAI
use
pattern
A,B
A.B
A,B
A,B
Does EPA Have
Data to Satisfy
This Requirement Bibliographic
(Yes, No, Partially) Citation
Partially 160000
No
No
No
Must
Data
Under
tion
Yes
Yes
Nql/
NoV
Additional Tlmeframe
Be Submitted for
FIFRA Sec- Submission
3(c)(2)(B)7 I/
9 Months
9 Months


71-5 - Simulated and Actual
         Field Testing -

         Mammals and Birds

AQUATIC ORGANISM TESTING

72-1 - Freshwater- Pish
72-2 - Acute LC5o Freshwater
         Invertebrates

72-3 - Acute 1050 Estuarlne
         and Marine Organisms

72-4 - Fish Early Life Stage
         and Aquatic Inverte-
         brate Life Cycle
TEP



TGAI


TGAI


TGAI



TGAI
A,B



A,B


A,B


A
No



Yes


Yes


No



No
40094602, 00115433
    GS0144-12

   40094602
                                                                                               No
No
                       NoV
                                                 NoV

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               TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Tlmef rame
Does EPA Have Must Additional for
Data to Satisfy Data Be Submitted Submission
Use This Requirement Bibliographic Under FIFRA Sec- I/
Data Requirement Composition Pattern (Yes, No, Partially) Citation tlon 3(c)(2)(B)?
§158.145 Wildlife and Aquatic Organisms (cont'd)
72-5 - Pish Life Cycle TGAI A No
72-6 - Aquatic Organism TGAI, PAI A No
Accumulation or Degra-
dation
Product
72-7 - Simulated or Actual TEP A No
Field Testing -
Aquatic Organism
§158-150 Plant Protection
121-1 - TARGET AREA i
PHYTOTOXICITY TEP A,B No
NONTARGET AREA PHYTOTOXICITY
TIER I
122-1 - Seed Germination/
Seedling Emergence TGAI A,B No
122-1 - Vegetative Vigor TGAI A,B No
122-2 - Aquatic Plant Growth TGAI A,B No
LTI
O
NoV
NoV
NoV
NoV
NoV
NoV
NqV


-------
                                                         TABLE  A
                                          GENERIC DATA REQUIREMENTS FOR  PROPHAM
 Data Requirement
Composition
           Does EPA Have
           Data to Satisfy
  Use  •    This Requirement    Bibliographic
Pattern   (Yes, No, Partially)    Citation
                                                                                          Must Additional     Tlmeframe
                                                                                          Data Be Submitted      for
                                                                                          Under FIFRA Sec-   Submission
                                                                                          tion 3(c)(2)(B)7	I/
§158-150 Plant Protection

        TIER II

123-1 - Seed Germination/
        Seedling Emergence
    -1 - Honey bee acute
           contact 11)50
                                TGAI

                                TGAI
123-1 - Vegetative Vigor

123-2 - Aquatic Plant Growth   TGAI

        TIER III

124-1 - Terrestrial Field      TEP

124-2 - Aquatic Field          TEP

§158.155 Nontarget Insect

NONTARGET INSECT TESTING -
POLLINATORS:
                A,B

                A,B

                A,B



                A,B

                D
                No

                No

                No



                No

                No
                                                                                               Nql/

                                                                                               NoJ/



                                                                                               Nol/

                                                                                               No
  TGAI
  A,B
                                                           Yes
                                                                             00036935
No
V Available information on the chemical and its use patterns Indicate that these studies are not required.

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                                                         TABLE A
                                          GENERIC DATA REQUIREMENTS FOR PROPHAM
Data Requirement
Composition
Use
Pattern
Does EPA Have
Data to Satisfy
This Requirement Bibliographic
(Yes, No, Partially) Citation
Must Additional Tlmeframe
Data Be Submitted for
Under PIFRA Sec- Submission
tion 3(c)(2)(B)7
§158-155 Nontarget Insect

141-2 - Honey bee - toxlclty
          of residues on
          foliage

l/jl-i| - Honey bee subacute
          feeding study
   -5 - Field testing for
          pollinators
NONTARGET INSECT TESTING -
AQUATIC INSECTS;

142-1 - Acute toxicity to
          aquatic insects

142-2 - Aquatic insect
          life cycle study

142-3 - Simulated or actual
          field testing for
          aquatic insects

143-1 - NONTARGET INSECT
 thru   TESTING PREDATORS
143-3   AND PARASITES
TEP           A,B
[Reserved]2/
TEP           A,B
[Reserved]^/


[Reserved]^/



[Reserved]3/



[Reserved]3/
No
No

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                                                         TABLE A
                                           GENERIC  DATA REQUIREMENTS FOR  PROPHAM

Footnotes

V Data from this study is not required  at  this  time.  Requirement will depend on  results  of acute contact study.
-  I? the a^ute contact study demonstrates  toxiclty to the  bees then the  field study would be necessary.
2/ Reserved pending development of test  methodology.

V Reserved pending Agency decision as to whether the data  requirement should be established.
    Ui
    OJ

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                                                TABLE A
                                  GENERIC  DATA  REQUIREMENTS  FOR  PROPHAM
Data Requirement Composition
§158.135 Toxicology

Does EPA Have Data Must Additional
to Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under PIPRA Section
No or Partially?) Citation 3(c)(2)(B)?


Tljne frame
for
Submlsslonl/

ACUTE TESTING:
81-1
81-2
81-3
81-1
81-5
81-6
81-7
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation - Rabbit
- Dermal Sensltlzatlon -
Guinea Pig
- Acute Delayed
Neurotoxlclty - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Yes
Yes
No
No
No
No
No
00115421 No
00115422 No
Yes
Yes
Yes
Yes
No£/


9 Months
9 Months
9 Months
9 Months

SUBCHRONIC TESTING:
82-1

- 90-Day Feeding -
Rodent
. Nonrodent
TGAI
TGAI
No
No
Yes - 15 Months
Yes -' 18 Months


01

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                                                      TABLE A
                                       GENERIC DATA REQUIREMENTS FOR PROPHAM
Data Requirement
§158.135 Toxicology (continued)
82-2
82-3
82-4
82-5
- 21-Day Dermal
- 90-Day Dermal
- 90-Day Inhalation -
Rat
- 90-Day Neurotoxicity
Does EPA Have Data Must Additional
to Satisfy This Data Be Submitted Timeframes
Requirement? (Yes, Bibliographic Under PIFRA Section for
Composition No or Partially?) Citation 3(c)(2)(B)7 submission I/
TGAI No
TGAI No
TGAI
No
TGAI No
Yes
3/
No~
3/
No
V
No
12 Months

CHRONIC TESTING:
83-1

83-2

83-3

83-4
- Chronic Toxicity -
Rodent
Nonrodent
- Qncogenicity Study -
Rat
Mouse
- Teratogenlclty -
Rat
Rabbit
- Reproduction
TGAI
No
No
TGAI
No
No
TGAI
Yes
No
TGAI No
Yes
Yes
Yes
Yes
00115^34 No
Yes
Yes
50 Months
50 Months
50 Months
50 Months

15 Months
39 Months
un
en

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                                                        TABLE A
                                         GENERIC DATA REQUIREMENTS FOR  PROPHAM
Data Requirement
 Composition
Does EPA Have Data
to Satisfy This
Requirement? (Yes,
No or Partially?)
                                                                      Bibliographic
                                                                        Citation
Must Additional
Data Be Submitted     Tlmeframe
Under PIFRA Section     for
3(c)(2)(B)7          Submission I/
§158.135 Toxicology (continued)

  MUTAGENICITY TESTING

  84-2 - Gene Mutation

  84-2 - Chromosomal Aberration

  84-2 - Other Mechanisms of
          Mutagenlclty

  SPECIAL TESTING

  85-1 - General Metabolism
    TGAI           No

    TGAI           No

    TGAI           No




PAI or PAIRA       No
                                       Yes

                                       Yes

                                       Yes
                                       Yes
                       9 Months

                      12 Months

                      12 Months




                      24 Months
   I/ Tlmeframes listed  start on  the  Issuance date of this document.
   2/ The compound Is not an organophosphate.  The test Is not  required.
   3/ This test Is not currently  required, due to the lack of exposure data and may be required after the  exposure data
      Is submitted and reviewed.
   V This test is not required because the acute hen test is not  required  and the compound has not shown
      neurotoxicity in a manrnalian species.
   Ul
   O\

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                                                       TABLE B
                PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PROPHAM
Data Requirement
§158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral - Rat
81-2 - Acute Dermal
81-3 - Acute Inhalation - Rat
81-4 - Primary Eye
Composition

MP
MP
MP
MP
Does EPA Have Data
to Satisfy This
Requirement? (Yes,
No or Partially?)

No
No
No
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?

Yes - 9 Months
Yes - 9 Months
Yes - 9 Months
Yes - 9 Months
        •Irritation - Rabbit

81-5 - Primary Dermal
        Irritation

81-6 - Dermal Sensitization
MP
MP
No


No
Yes - 9 Months
Yes - 9 Months

-------
                          SUMMARY-1

                        LABEL CONTENTS

     40 CPR 162.10 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 CPR I62.10(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 I62.10(e)]

    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 CPR I62.10(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 CPR l62.10(g)]


                                   58

-------
                            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 162.10(h)(1)(11)]

    Item 78.  SIGNAL WORD - The signal word (DANGER, WARNING,
or CaUTION) is required on the front panel immediately below
the child hazard warning statement.  [40 CFR 162.10 (h)(!)(!)]

    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 162.10(h)(1)(1)]

    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 I62.10(h)(1)(ill)]

    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 I62;10(h)(l)(lii)]

    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 l62.10(h)(2) ].


                                   59

-------
                          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.  [10 CFR 162.10(h)(2)(1)]

    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.  [10 CFR 162.10(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 section, 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 I62.11(c).  You will be notified  of
the Agency's classification decision.

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                          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 1*0
     CPR
         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.  Some 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
     reregistratlon, 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.
                                 61

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                          SUMMARY-5

    Item IDA.  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.
    CFR 162.10]
                     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.
                                   62

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                                                   SUMMARY-6
                                 LABELING REQUIREMENTS OP THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal wore]
APPLICABILITY
OP REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
al/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
PhEf'EKKEU
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immed lately
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.
CN

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                                                   SUMMARY-?
ITEM
7C
7D
7E
8
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
OP REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxlcity
All products
in Categories
I, 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
precautionary
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.
CN

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                                                 SUMMARY-8
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
OP REQUIREMENT
All pressurized
products, others
with flash
points under
150°P
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked

Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product In a manner
inconsistent with its labeling."

Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
Information and required statements.
May be in metric as well as U.S. units
ON-
en

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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 the 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) of 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)  AH  required  label  text must-;
   (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 may 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
                                     66

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 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, the 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;
                                      67

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   (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  § 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
 pressurizedi  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."
                                   68

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   (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  on the wrapper or outside container of
 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 o'f 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.  iinii»«« i-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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   (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  name by  the  Administrator
 under the authority of  Section 25(c){6).
   (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
 pract.ice.   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 be 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  hazard to children, environmental
 hazard, and  physical or chcir-ic-l 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:
                                   70

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Hazard Indicators

Oral LD5Q
Inhalation LC
Dermal LD
Eye effects
Skin effects


1
Up to and
Includ Ing
50 rag/ kg
Up to and
Including
.2 mg/llter
Up to and
Including
200 mg/kg
Corrosive;
cornea 1 opacity
not reversible
within 7 days
Corrosive

Toxic Ity <
II
From 50 Thru
500 mg/kg
From .2 thru
2 mg/ liter
From 200
thru 2000
Cornea 1 opacity
reversible
• Ithln 7 days;
Irritation
persisting for
7 days
Seve-a Irritation
at 72 hours

:ategor les
III
F-om 500 thru
5000 mg/kg
F-om 2 thro
20 mg/ liter
From 2,000 thru
20,000
No cornea! opacity;
Irritation
reversible
within 7 days
Mode-ate Irritation
at 72 hou-s


IV
Greater than
5000 mg/kg
Greater than
20 ng/l Iter
Greater than
20,000
No Irritation
Ml Id or si 'ght
Irritation at
72 hours
  (i)  Human hazard signal word.--(A)  Toxicity Category I.  All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger."  In
addition if the product was assigned
the basis of  its oral, ir.halat icr. or
from skin and eye local effects) the
in red on a background of distinctly
skull and crossbones shall appear in
word "poison."
  (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."
       to Toxicity Category I on
       dermal toxicity (as distinct
       word "Poison" shall appear
       contrasting color and the
       immediate proximity to the
All pesticide products meeting the
II shall bear on the front panel"

 All pesticide products meeting the
III shall bear on the front panel
All pesticide
IV shall bear
products meeting the
on the front panel
                                   71

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   (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


Above 10 to 15 	
Above 15 to 30 	

Poir
Required
signal word,
all capitals
c.
i n
1 7
1 4
18
its
"Keep out
of reach of
Children"



i n
1 U
12
                                     72

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    (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.
        I
Toxic I ty  |	
category  |  Oral, Inhalation, or dermal toxic I1>
                  Precautionary statements by toxlclty category
                                          Skin and eye local effects
11 I
 IV
         Fatal  (poisonous) If swallowed (Inhaled or
          absorbed through sklnl.  Do not breathe
          vapor Idustl or spray mlstl.  Do not get
          In eyes, on skin, or on clothing [Front
          panel statement of practical T-eatment
        May be fatal If swallowed (Inhaled or
         abso-bed through the skin).  Oo not breathe
         vapo-s Idust or spray nlst).  Oo not get ln|
         eyes, on skin, or on clothing. I Appropriate)
         first aid statements required.!.         |
                                    Corrosive, causes eye and skin damage lor
                                     skin Irritation).  Do 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 eye land skin! Irritation. Do not
                                     get In eyes, on skin, or on clothing.
                                     Harmful If swallowed.  [Appropriate first
                                     aid statement required.).
Harmful  If swallowed (Inhaled or absorbed   | Avoid contact with skin, eyes or clothing.
 through the skin).  Avoid breathing vapors  |  In case of contact Immediately flush
 [dust or spray mist).  Avoid contact with  |  eyes or skin with plenty of water.  Get
 sk'n [eyes or clothing).  [Appropriate
 first aid statement required.].

[No precautionary statements required.).
                                             medical attention If Irritation persists.
(No precautionary statements required.).
   (ii)   Environmental hazards.
target  organisms  excluding
statements are required  stating
appropriate  precautions  to avoid
                        	    Where  a hazard exists  to non-
                        humans and  domestic animals,  precautionary
                              the nature of the  hazard and  the
                               potential accident, injury or
                                        73

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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 active
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 active
ingredient with a fish acute LC5Q of 1 ppm or less, the statement
"This Pesticide is Toxic to Fish" is required.
   (C)   If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD5Q of 100 mg/kg or less, or
a subacute dietary LC$Q 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 the
flammability or explosive characteristics of the pesticide are
required as follows:
Flash point
(A) PRESSURIZED
Flash point at or belo* 20*F; If tnere Is a
flashback at any valve opening.
Flash point above 20"F and not over 80*F or If
trie flame extension Is more than 18 In. long
at a distance of 6 In. from the flame.

(B) NONPRESSURh



Required text
CONTAINERS
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 r'y c«"S» *•• <-«»lng.
Flammable. Contents under pressure. Keep away
from heat, sparks, and open 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 tempera-
tures above 130*F may cause bursting.
ED CONTAINERS
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 or open flame.
                              74

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   (i)  Directions for Use—(1)   General requirements—(i)   Adequacy
 and clarity of directions.   Directions Cor 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.
   (iii)   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:
   (_!)   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;
   (2)   The  product will  not come into the hands of the  general
 public  except  after incorporation  into finished products;  and
   (£)   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 for which sale is limited to ohysicians,
 veterinarians,  or  druggists, provided that:
   (I)   The  label  clearly states that the product is Cor 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
   (Y)  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:
   (I)  There is  information readily  available  to the formulators
on the composition,  toxicity, methods of use,  applicable restrictions
or limitations,  and  effectiveness  of the product for pesticide
purposes ;
                                     /5

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   (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;
   (_3)  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 " :
   (i)  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  (See  Table  in  §  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]
   (E)  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.
                                    76

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   (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 ) ( 1) 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 § 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 § 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 FR 28268, July 3, 1975; 40  FR  32329,  Aug. 1,  1975;  40 FR
38571,  Aug. 21,  1975, as amended at  43 FR 5786, Feb.  9,  1978]
                                   77

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                           PHYS/CHEM-1
                    PHYSICAL/CHEMICAL HAZARDS
Criteria
I.  Pressurized Containers

    A.  Flashpoint at or below
        20°P; or if there is a
        flashback at any valve
        opening.
    B.  Flashpoint above 20°F
        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.
    ".   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.
                                       78

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                            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
    vrhile 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.
                                    79

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                                FEST/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 below contain the exact wording that must appear on
the label of these products:

1.  The 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."
                                              80

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                          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, cans, 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:
 Container Type
 Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or 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)
  \f Manufacturer may replace this phrase with one indicating
     whether and how fiber drum may be reused.
                                  81

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                      EPA  Index to Pesticide Chemicals

                           ISOPROPYL CARBANILATE
                                                                     -V* L

                             TABLE OF CONTENTS                        O

Site Name	Page

TERRESTRIAL FOOD CROP                                              2
  (Agricultural Crops)                                             2
  Alfalfa                                                          2
  Bentgrass (Astoria/Highland)                                     3
  Chewing*s Fescue                                                 3
  Clover                                                           4
  Creeping Red Fescue                                              3
  Crimson Clover                                                   4
  Flax                                                             4
  Kentucky Bluegrass                                               3
  Ladlno Clover         .                                           4
  Lentils                                                          4
  Lettuce                                                          5
  Orchardgrass                                                     3
  Peas (green or dry)                                              5
  Perennial Ryegrass                                               3
  Red Clover                                  .                     4
  Saf flower                                                        6
  Spinach                                                          6
  Sugar Beets                                                      7
  Tall Fescue                                                      3
  White Clover                                                     4
  (Noncrop, Wide Areas, and General Indoor/Outdoor Treatments)     8
  Fallowland8

TERRESTRIAL NON-FOOD  CROP                                           8
  (Agricultural Crops)                                              8
  Alfalfa (seed crop)                                               8
  Clover (seed crop)                                                8
  Grasses Grown for Seed                                            8
  Spinach (grove for  seed)                                          9
  (Noncrop, Wide Area, and General  Indoor/Outdoor Treatments)       9
  Noncrop Areas                                                     9
Issued:  2-20-86                 1-047601-i

                                        82

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                                 EPA Index co Pesticide  Chemicals

1047601                                ISOPROPYL CARBANILATE*

            TYPE  PESTICIDE:   Herbicide

            FORMULATIONS:
            C    (15%)
            F1C  (3  Ib/gal or 31% a.i., 4  Ib/gal or 43Z a.l.)

            GENERAL  WARNPfGS  AND LIMITATIONS:  A selective preplant, preemergence, and
            postemergence herbicide for control of certain annual broadleaf weeds and
            winter grasses.   Keep out of lakes, ponds, or streams.  Do not contaminate
            bodies of water by cleaning of equipment or disposal of wastes.  This
            product  breaks down rapidly in warm, moist soil, and, therefore is more
            effective on cool season crops where soil temperatures are below 55 F
            (12.8 C).  Do not apply when wind speed favors drift.  For strip or band
            treatments reduce dosages and water dilution rates proportionately.  Main-
            tain agitation during application of the flowable concentrate formula-
            tions.
            Interim  Tolerances;  While petitions for tolerances for negligible resi-
            dues are pending  and until action is completed, interim tolerances are
            established.
            Livestock Tolerances;
            Cattle,  fat        0.05 (I) ppm
            Cattle,  meat       0.05 (I) ppm
            Cattle, mbyp       0.05 (I) ppm
            Eggs               0.05 (I) ppm
            Goats, fat         0.05 (I) ppm
            Goats, meat        0.05 (I) ppm
            Goats, mbyp        0.05 (I) ppm
            Hogs,  fat          0.05 (I) ppm
            Hogs,  meat         0.05 (I) ppm
            Hogs,  mbyp         0.05 (I) ppm
            Horses,  fat        0.05 (I) ppm
            Horses,  meat       0.05 (I) ppm
            Horses, mbyp       0.05 (I) ppm
            Milk               0.05 (I) ppm
            Poultry, fat       0.05 (I) ppm
            Poultry, meat      0.05 (I) ppm
            Poultry, mbyp      -0.05 (I) ppm
            Sheep, fat         0.05 (I) ppm
            Sheep, meat        0.05 (I) ppm
            Sheep, mbyp        0.05 (I) ppm

           TIME REQUIRED FOR CONTROL!  Not located.

            PHYTOTOXICITY TO  TARGET WEEDS:  Not located.

            PHYTOTOXICITY TO  CROPS;  Not located.

           MODE OF ACTION;   Disrupts normal cell division,  inhibits protein and
            amylase  synthesis, Inhibits photolytic activity  of Isolated chloroplasts
           and affects the activity of messenger RNA.


            *propham

            Issued:  2-20-86                 1-047601-1
                                                    83

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 FGAEBF
 AZAAAC
                      EPA Index to Pesticide  Chemicals

                            ISOPROPYL CARBANILATE

 BROADLEAF  WEEDS  CONTROLLED;

   Burning  nettle
   Chickweed
            GRASSES AND OTHER MONOCOTS CONTROLLED:

PCACKBA       Annual bluegrass
 3ABSBJ       Barley (volunteer)
 CACHBB       Canarygrass
PCABRBA       Common velvetgrass
 CAATBM       Downy brome
 :ACUAA       Foxtail
rCABZBA       Italian ryegrass
PCACLBB       Rabbicfoot polypogon
 3AEABE       Rattail fescue
 lADFBA       Wheat (volunteer)
PCAAOBB       Wild oats
 :ACUBD       Yellow foxtail
/'.3001AA
Site, Dosage
and Formulation
(Ib a.i./A)

TERRESTRIAL FOOD CROP

  (Agricultural Crops)

  Alfalfa
                                    Tolerance, Use, Limitations
                3-4
                (4 Ib/gal F1C)
                 000748-00207
                3-4
                (4 Ib/gal F1C)
5.0 (I) ppm (alfalfa, hay)
2.0 (I) ppm (alfalfa)
Do not graze or harvest for feed within 50 days
after application.
General Information;  Irrigate within 5 days of
application.  U»e the lower dosages on coarse and
medium textured soils and the higher dosages on
fine textured soils.

Preplant.  Broadcast.  Apply in 20 to 60 gallons
of water per acre by ground, or 5 to 10 gallons
of total spray solution per acre by air within 2
days of planting.

Preemergence.  Broadcast.  Apply in 20 to 60 gal-
lons of water per acre by ground, or 5 to 10 gal-
lons of total spray solution per acre by air with-
in 2 days after planting.
            Issued:   2-20-86
                                1-047601-2
                                                      84

-------
                      EPA Index Co Pesticide Chemicals

                            ISOPROPYL CARBANILATE
/33025AA

/33024AA
/33111AA
/22030AA
/22028AA
/22035AA
/22043AA
 Site,  Dosage
 and  Formulation
 (Ib  a.i./A)

  Alfalfa  (continued)

     3-5
     (15Z G)
     000748-00211
     (4 Ib/gal  F1C)
     [SLN]
     4-6
     (15Z G)
     (4 Ib/gal F1C)
    [SLN]
    3-4
    (4 Ib/gal F1C)
    [SLN]
    4
    (4 Ib/gal F1C)
  Bentgrass (Astoria/
   Highland)
  Chewing 's Fescue
  Creeping Red Fescue
  KentttcVy
  Orchardgrass
  Perennial Ryegrass
  Tall Fescue
    3-4
    (4 Ib/gal FIG)
     000748-00207
                                    Tolerance, Use, Limitations
  Chewing'a Fescue
 Postemergence.  Broadcast.  Apply in the winter
 or early spring.  Kay be applied to established
 alfalfa or to seeding stands with 3 or more true
 leaves.  Apply in 20 to 60 gallons of water per
 acre by ground, or 5 to 10 gallons of total spray
 solution per acre by air.

 SLN - Use limited to CA, NV, OR, and WA.
 Postemergence.  Broadcast application to new seed-
 ing and established stands.  Apply in the late
fall,  winter, or early spring when alfalfa has at
 least  3 true leaves.   Apply before April 15.   Ap-
ply the flowable concentrate in 20 to 60 gallons
of water per acre by ground, or 5 to 10 gallons
of total spray solution per acre by air.

SLN - Use limited to OR and WA.
 Postemergence.  Broadcast.  Apply water and prod-
uct mixture by center pivot sprinkler irrigation.
Apply  0.5 to 1 inch of water per acre.

 SLN - Use limited to CA.
 Postemergence.  Mix 1 part product to 4 parts
water and meter into irrigation water.   New seed-
ling alfalfa should have at least 3 true leaves
before application.

 5.0 (I) ppm (grasses, hay)
 2.0 (I) ppm (grasses)
 General Information;  Straw and plant residues
should be removed before application.  Avoid ap-
plying on warm, windy days-  Reduce application
 rates In low spots where surface water may cause
accumulation of the chemical injuring crops.  Use
on established fields which have been harvested
at least once.

Use limited to OR, west of the Cascade Mountains.
Broadcast.   Apply in 20 or more gallons of water
per acre.  Spray In October after fall rains have
started.  Do not spray after October 31.  For
chewing*s fescue and creeping red fescue, apply
from October 1 to October 20.

See Bentgrass (Astoria/Highland) cluster.
Issued:  2-20-86
                                            1-047601-3

                                                   85

-------
'23003AA
'23018AA
 23016AA
 23014AA
'23017AA
 8009AA
 5011AA
Site,  Dosage
and Formulation
(Ib a.i./A)

  Clover
  Crimson Clover
  Ladino Clover
  Red  Clover
  White Clover
                (4 Ib/gal  F1C)
                 000748-00207
                3-4
                (4 Ib/gal F1C)
                4.00-5.25
                (15Z  G)
                 000748-00211
  Creeping Red Fescue

  Crimson  Clover

  Flax
    4
    (15Z  G)
    000748-00211

  Ladino  Clover

  Lentils
                (4 Ib/gal  F1C)
                000748-00207
                                 EPA Index Co Pesticide Chemicals

                                       ISOPROPYL  CARBANILATE

                                    Tolerance, Use, Limitations
5.0 (I) ppm (clover, hay)
2.0 (I) ppm (clover)
General Information:  Irrigate within 5 days  of
application.  Use the lower dosages on coarse and
medium textured soils and the higher dosages  on
fine textured soils.

Preplant.  Broadcast.  Apply in 20 to 60 gallons
of water per acre by ground, or 5 to 10 gallons
of total spray solution per acre by air within 2
days of planting.

Preemergence.  Broadcast.  Apply in 20 to 60  gal-
lons of water per acre by ground, or 5 to 10  gal-
lons of total spray solution per acre by air  with-
in 2 days after planting.

Postemergence.  Broadcast.  Apply in 20 to 60 gal-
lons of water per acre in the vinter or early
spring.  Seedling stands should have 3 or more
true leaves.  Apply by ground or by air.

See Bentgrass (Astoria/Highland) cluster.

See Clover cluster.

0.1 (I) ppm (flax seed)
General Information;  Irrigate within 3 days  of
application.

Postemergence.  Broadcast.  Apply when flax is 2
to 4 inches high and germinating weeds are less
than 4 Inches high.  Apply by ground or by air.

See Clover cluster.

0.1 (I) ppm

Preplant.  Broadcast.  For control of barley (vol-
unteer), wheat (volunteer), and wild oats.  Apply
In 10 to 20 gallons of water per acre by ground,
or 5 to 10 gallons of total spray solution per
acre by air.  Spray mixture directly onto soil
surface and Immediately cross disk to a depth of
at least 4 inches.  Seed may be planted the same
day but no later than 1 to 2 days after treatment.
           Issued:   2-20-86
                                1-047601-4

                                        86

-------
                                  EPA Index to Pesticide Chemicals
 '13020AA
Site,  Dosage
and Formulation
(lb a.i./A)

  Lettuce
                4-6
                (4 Ib/gal F1C)
                 000748-00207
                3-4
                (4 Ib/gal F1C)
                3.75-6.00
                (4 Ib/gal F1C)
/15009AA
                4.5-6.0
                (4 Ib/gal F1C)
 Kentucky Bluegraas

 Orchardgrass

 Peas  (green or dry)
                (4 Ib/gal F1C)
                 000748-00207
                                        ISOPROPYL CARBANILATE

                                    Tolerance, Use, Limitations
0.1  (I) ppm
General Information:
                                                          Use the lower dosage on
coarse textured soils and the higher dosage on
fine textured soils.

Use limited to AZ and CA.  Preplant.  Broadcast.
Apply In 20 to 40 gallons of water per acre by
ground, or 5 to 10 gallons of total spray solution
per acre by air within 2 days of planting.  Incor-
porate with a rotary tiller into the top 2 inches
of soil.  Furrow irrigation a few days after ap-
plication is recommended for preplant treatments.

Use limited to AZ, CA, CO, and NM.  Preplant.
Broadcast.  Apply in 40 to 60 gallons of water per
acre by ground, or 5 to 10 gallons of total spray
solution per acre by air.  Incorporate with a
rotary tiller or a double disk with harrow into
the top 2 Inches of soil.  Furrow irrigation a few
days after application is recommended for preplant
treatments.
Tank mix with benfluralin.

Preemergence.  Broadcasf.  Apply in 20 to 40 gal-
lons of water per acre by ground, or 5 to 10 gal-
lons of total spray solution per acre by air with-
in 2 days after planting.  Irrigate by sprinkler
(0.5 inch water) within a few days after applica-
tion if there is no rainfall.

Postemergence.  Directed (shielded) spray.  Apply
in 40 gallons of water per acre when the lettuce
has at least 4 or more true leaves.

See Bentgrass (Astoria/Highland) cluster.

See Bentgrass (Astoria/Highland) cluster.

0.1 (I) ppm
General Information;  Irrigate within 3 days of
application.

Preplant.  Broadcast.  For control of barley (vol-
unteer), wheat (volunteer), and wild oats.  Apply"
in 10 to 20 gallons of water per acre by ground,
or 5 to 10 gallons of total spray solution per
acre by air.  Spray mixture directly onto soil
surface and immediately cross disk to a depth of
            Issued:  2-20-86
                                1-047601-5
                                                      87

-------
            Site, Dosage            	
            and Formulation
            (lb a.l./A)

              Peas (green or dry) (continued)
                    EPA Index to Pesticide  Chemicals

                         ISOPROPYL CARBANILATE

                      Tolerance, Use, Limitations
 D8034AA
  (15Z G)
   000748-00211

Perennial Ryegrass

Red Clover

Safflower
'•".3024AA
                3-4
                (4 Ib/gal F1C)
                 000748-00207
                3-4
                (4 Ib/gal F1C)
Spinach
                4-5
                (4 Ib/gal FIG)
                 000748-00207
                4-5
                (4 Ib/gal F1C)
                                    at least 4 inches.  Seed may be planted  the  same
                                    day but no later than 1 to 2 days after  treatment.

                                    Postemergence.  Broadcast.  Apply when peas  have
                                    4 or more true leaves.  Apply by ground  or by air.
See Bentgrass (Astoria/Highland) cluster.

See Clover cluster.

0.1 (I) ppm (safflower, seed)
General Information!  Use the lower dosage on
coarse and medium textured soils and the higher
dosage on fine textured soils.

Preplant.  Broadcast.  Apply in 35 to 50 gallons
of water per acre within 2 days of planting.
Shallow incorporate 1 to 2 inches and follow with
furrow irrigation within 2 days after application.

Preemergence.  Broadcast.  Apply in 35 to 50 gal-
lons of water per acre within 2 days after plant-
ing.  Sprinkler irrigation is essential after
treatment if no rain occurs.
0.1 (I) ppm
General Information:
                                                          Irrigate within a few days
                                    of application.  Use Che lower dosage on coarse
                                    textured soils and the higher dosage on fine tex-
                                    tured soils.
                      Preemergence.  Broadcast.  Apply in 20 to 40 gal-
                      lons of water per acre after planting.  Follow
                      with 0.5 inch of water by sprinkler Irrigation if
                      no rain occurs within a few days.

                      Postemergence.  Broadcast.  Apply In 20 to 40 gal-
                      lons of water per acre when spinach is in the 2
                      to 4 leaf stage.  Follow with 1 inch of water by
                      sprinkler irrigation if no rain occurs within a
                      few days.
            Issued:   2-20-86
                              1-047601-6
                                                      88

-------
/28020AA
Site, Dosage
and Formulation
(Ib a.I./A)

  Sugar Beets
                (4 Ib/gal  FIG)
                 000748-00207
                4.00-5.25
                (15%  G)
                 000748^00211
               4.5-6.0
               (4  Ib/gal F1C)
               (4 Ib/gal F1C)
                [SLN]
                4-6
                (4 Ib/gal F1C)

             Tall Fescue

             White Clover
                                  EPA  Index to Pesticide Chemicals

                                       ISOPROPYL CARBAXILATE

                                    Tolerance,  Use,  Limitations
0.1 (I) ppm (beets, sugar (roots, tops))
General Information;  Irrigate within 3 days after
application.  Use the lower dosages on coarse tex-
tured soils and the higher dosages on medium/fine
textured soils.

Preplant.  Broadcast.  For control of barley (vol-
unteer), wheat (volunteer), and wild oats.  Apply
In 10 to 20 gallons of water per acre.Spray mix-
ture directly onto soil surface and immediately
cross disk to a depth of at least 4 inches.  Seed
may be planted the same day but no later than 1
to 2 days after treatment.

Fostemergence.  Broadcast.  Apply when beets are
between the 4 true leaf stage and the rosette
stage but prior to tight crown development.  Ap-
ply by ground or by air.

Postemergence.  Directed (shielded) spray.  Apply
in 40 gallons of water per acre when beets have 4
to 8 true leaves.

Use limited to ID, OR, and VA.  Preplant, preemer-
gence, or postemergence.   Apply by ground, by air,
or by center pivot sprinkler irrigation.  Use the
air or center pivot sprinkler irrigation applica-
tions on preplant or preemergence only.

SLN - Use limited to CA.
Postemergence.  Apply in irrigation water when
beets have at least 6 true leaves.

See Bentgrass (Astoria/Highland) cluster.

See Clover cluster.
           Issued:  2-20-86
                               1-047601-7
                                                     89

-------
                                  EPA Index  to  Pesticide Chemicals
                                       ISOPROPYL CARBANILATE
            Site, Dosage
            and Formulation
            (Ib a.i./A)
Tolerance, Use, Limitations
              (Noncrop, Wide Areas, and General Indoor/Outdoor Treatments)
 660020A      Fallowland
                3-4
                (3 Ib/gal F1C)
                 000748-00224
                [SLN]
                3-4
                (3 Ib/gal F1C)
Do not graze or plant crops in treated areas with-
in 8 months of application.

Broadcast.  Apply in the fall or winter after soil
temperatures have cooled to 50 F (10.0 C) at a
depth of 1 inch.  Apply in 20 or more gallons of
water per acre by ground or 5 to 10 gallons of
water per acre by air.  Use the lower dosage for
preemergence weeds and the higher dosage when
weeds have 4 or more leaves.

SLN - Use limited to CO, OR, DT, and WA.
Broadcast to fallowland to be planted to wheat
(wheat-fallow-wheat).  Apply in 10 or more gallons
of water per acre by ground or 5 or more gallons  .
of water per acre to stubble in fall or early win-
ter but not after March 1.
Tank mix with atrazine, metrlbuzin, paraquat, or
2-chlorsulfuron.
            TERRESTRIAL NON-FOOD CROP
              (Agricultural Crops)

/73001DA      Alfalfa (seed crop)
 :3003DA      Clover (seed crop)

                4-5
                (152 G)
                 000748-00211
  8066DA      Grasses Grown for
               Seed
                3-4
                (4 Ib/gal F1C)
                 000748-00207
N.F.
Postemergence.  Broadcast.  Apply when crops have
3 or more true leaves and the soil temperature has
cooled to 55 F (12.? C) or lower.  Apply by ground
or by air.
                      Straw and plant residues
N.F.
General Information;
should be removed before application.

Use limited to WA.  Postemergence.  Apply to es-
tablished grasses between September 15 and October
15.  Apply when grasses are in the 1 leaf stage.
            Issued:   2-20-86
        1-047601-8
                                                      90

-------
                                  EPA Index to Pesticide Chemicals
 /13024DA
Site, Dosage
and Formulation
(lb a.i./A)

  Spinach (grown for
   seed)
                 [SLN]
                 4-5
                 (4 Ib/gal  F1C)
                                        ISOPROPYL  CARBANILATE
                                     Tolerance, Use,  Limitations
N.F.
Do not use treated crops or crop residue for food
or feed.
General Information;  Irrigate 7 to 10 days fol-
lowing application.  Crops, except wheat,  may be
rotated 3 months after application.  Wheat may be
planted 9 months after application.

SLN - Use limited to western WA.
Preemergence.  Broadcast.  Soil surface treatment.
Apply in 20 to 40 gallons of water per acre.
Tank mix with diethatyl-ethyl.
              (Noncrop, Wide Area, and General Indoor/Outdoor Treatments)
/670000A
 Noncrop  Areas
                3-4
                (3 Ib/gal F1C)
                 000748-00224
                        Do not graze or plant crops in treated areas with-
                        in 8 months of application.  Do not apply after
                        March 1.
                        General  Information:  This site includes fence-
                        rows, roadsides, ditches, and lanes.

                        Broadcast.  Apply in the  fall or winter after the
                        soil temperatures haye cooled to 50 F (10.0 C) at
                        a depth  of 1 inch.  Apply in 20 or more gallons
                        of water per acre by ground or 5 to 10 gallons of
                        water per acre by air.  Use the lower dosage for
                        preemergence weeds and the higher dosage when
                        weeds have 4 or more leaves.
            AERIAL AKD TANK MIX APPLICATIONS
9001500
AAAAAAA
 Aerial Application
                                    Refer to

                                    TERRESTRIAL FOOD CROP
                                     (Agricultural Crops)
                                    Alfalfa, Clover, Crimson Clover, Flax, Ladino
                                    Clover, Peas, Red Clover, Sugar Beets, White
                                    Clover
                                     (Noncrop, Wide Area, and General Indoor/Outdoor
                                      Treatments)          ~~~
                                    Fallowland
            Issued:  2-20-86
                                1-047601-9
                                                      91

-------
                                 EPA Index Co Pesticide Chemicals

                                       ISOPROPYL  CARBANILATE

            Site,  Dosage             Tolerance. Use,  Limitations
            and  Formulation
            (Ib  a.i./A)

              Aerial  Application  (continued)

                                    TERRESTRIAL NON-FOOD  CROP
J900300
tAAAAAA
Tank Mix
                                     (Agricultural  Crops)
                                    Alfalfa  (seed crop),  Clover  (seed  crop)
                                     (Noncrop,  Wide  Area,  and  General  Indoor/Outdoor
                                      Treatments)
                                    Noncrop  Areas
                                    Refer  to

                                    TERRESTRIAL  FOOD  CROP
                                     (Agricultural  Crops)
                                    Lettuce-
                                     (Noncrop, Wide Area, and  General  Indoor/Outdoor
                                     Treatments)
                                    Fallovland

                                    TERRESTRIAL  NON-FOOD  CROP
                                     (Agricultural  Crops)
                                    Spinach (grown  for  seed)
           Issued:  2-20-86
                              1-047601-10
                                                      92

-------
 r. 015.0004
il04.0014
                      EPA Index to Pesticide  Chemicals

                           ISOPROPYL CARBANILATE

Listing of Registered Pesticide Products by Formulation

15% granular
  isopropyl carbanilate  (047601)
    000748-00211
                (000748-00211)
                        CA780057   NV780003
i!03.0014   3 Ib/gal (3U a.i.) flowable concentrate
              isopropyl carbanilate (047601)
                000748-00224*
                  Currently unavailable for review
                (000748-00224)
C0810025
WA810066
                                   OR810067
                                   WA840072
4 Ib/gal (43Z a.i.) flovable concentrate
  Isopropyl carbanilate (047601)
    000748-00207
                (000748-00207)
                        CA780058
                        OR770015
                        WAS30004
           CA780196
           OR830005
OR810078   OR840049
CA780211
WA770003
           NV780002
           WA830002
>999999      State  Label Registration

             WA Reg.  No.
                000748-06004
           Issued:  2-20-86
                                1-047601-11
                                                     93

-------
                       EPA  Index  to  Pesticide Chemicals

                            ISOPROPYL CARBANILATE

                                Appendix A-2'

 Listing of Active Ingredient(s) Which May Be  Included in Tank Mixes
 Chemical
   Code

 080803

 084301
 118601



 116701

 101101

 061603
Common Name
  (source)
benfluralin (ISO)
2-chlorosulfuron
 (ANSI)
   EPA Acceptable
Common/Chemical Name

atrazine

N-butyl-N-ehtyl-alpha,alpha,alpha-tri-
fluoro-2,6-dini t ro-p-toluidine

2-chloro-N-t((4-methoxy-6-methyl-l,3,5-
triazin-2-yl)amino)carbonyl]benzenesulfon-
amide

diethatyl-«thyl

metribuzin

paraquat
 — Use  EPA Acceptable Common/Chemical Name
Issued:  2-20-86
                   1-047601-12

                           94

-------
                      EPA Index to Pesticide  Chemicals

                            ISOPROPYL CARBANILATE

                          Auxiliary Documentation

                      Reg. No.        Cancellation Date

                    000748-00206          6/25/85

Registration  Number 000748-00224 was extracted from the fiche because it
could  not  be  located at EPA.
Issued:  2-20-86                1-047601-a

                                         95

-------
PROBl
CHEMICAL
               Ito»ropy1 ctrb«n|Uto
                                                   . ENVIRONMENTAL PROTECTION ACCNCY
                                                   OFFICE OF PESTICIDE
                                                                                                             RUN DATE! 05/22/Bft
                                                                                                             PAGE NO.I     1
                                                     INOEK BV BHAUCHNCBST CODEI 047*01 • H
CFR PPN
180,319 o.ll
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V.I!
2.D1
5.01
2.01
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0.11
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0.051
0.051
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CODE
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I5UIIAC
22000AA
2200QDA
23vO 1 AA
2300 lOA
23003AA
2J003UA
23W91A
25002AA
27034AA
2744BAA
2BOUAA
50UUOAA
5300IHA
5300IFA
530P1MA
530020A
53\>«2FA
530)2N«
530U3HA
53003FA
53*I03'IA
53I/054A
53005F.A
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55000FA
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55014AA
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                                                519
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                                                293
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                                                667
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                                               1040
                                               1054
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                                                912
                                                42B
LETTUCE
SPINACH
LE'lTILS
GRASSES
GRASSES, HAY
ALFALFA
ALFALFA, HAY
CLOVER
CLOVER, HAY
BEETS, SUGAR, TOPS
BEETS, SUGAR, ROOT!
FLAX SEED
SAFPLOHEft 3EEO
PEAS
"ILK
CATTLE, NBYP
CATTLE, FAT
CATTLE, HEAT
GOATS, «8YP
COATS, FAT
GOATS, MEAT
HOUSES, MBTP
NORSES, FAT
MOUSES, HEAT
SHEEP, NBYP
8HEE«», FAT
SHEEP, »EAT
HOGS, HBYP
HOGS, FAT
HOGS, MEAT
POULTRY, HBYP
POULTRY, FAT
POULTRY, HEAT
EGGS
                                                                                                                             \0

-------
ChemName:

Chem. Ho.;
                                               \
                                                '
                                                     Date:
Product Total from Printout
Total
Jackets Requested

Total
Received
f
•
Number
Used

Hunter
Not Used

Rec.  t
                    PM
                        RB
 Date
Requested
24
 Pfehe
lopy Date
Not
Used
                                                                Comwnts
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                                     v/
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                                        97

-------

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-------
                            BIBGUIDE-1

              GUIDE TO USE OP THIS BIB.LIOGRAPHY
1.  CONTENT OP 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 OP 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 OP 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 U(d)(U) 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
    f.ll MRID entries.  This temporary identifier number is
    also to be used whenever specific reference is needed.

4.  FORM OP 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.
                                    99

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                        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 i«t 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 123^56-A; the second, 123456-
         B;  the 26th, 123456-Z; and the 2?th, 123456-AA.
                                 100

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

00036935 Atkins, E.L.; Greywocd, E.A.; Macdonald, R.L. (1975) Toxicity of
            Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
            ratory Studies.  By University of California, Dept. of Entomolo-
            gy.   ?: UC, Cooperative Extension.  (Leaflet 2287; published
            study..)

00038956 Chen, Y. (1979) Characterization of IPC Metabolites in Wheat:  BR
            21572.  (Unpublished study received Sep 17, 1979 under 748-224;
            submitted by PPG Industries, Inc., Barberton, Ohio; CDL:
            240987-N)

00082676 Paulson, G.D.; Jacobsen, A.M.; Zaylskie, R.G.; et al. (1973) Iso-
            lation and identification of propham (isopropyl carbanilate)
            metabolites from the rat and the goat.  Journal of Agricultural
            and Food Chemistry 21(5):804-811.  (Also in unpublished submis-
            sion received Jan 2, 1974 under 2F1277; submitted by PPG Indus-
            tries, Inc., Barberton, Ohio; CDL:095l64-G)

00082681 Still, G.G.; Mansager, E.R. (1973) Metabolism of isopropyl car-
            banilate by soybean plants.  Pesticide Biochemistry and Physi-
            ology 3(3):289-299.  (Also in unpublished submission received
            Jan 2, 1974 under 2F1277; submitted by PPG Industries, Inc.,
            Barberton, Ohio; CDL:095l64-N)

00091226 Kennedy, G.; Jenkins, D.H. (1970) Report to PPG Industries, Inc.:
            Distribution of IPC in Milk and Tissues of a Lactating Cow: IBT
            No. J8629B.  (Unpublished study received on unknown date under
            1F1120; prepared by Industrial Bio-Test Laboratories, Inc.,
            submitted by PPG Industries, Inc., Pittsburgh, Pa.; CDL:
            090895-E)

00091227 Kennedy, G. (1970) Report to PPG Industries, Inc.: Tissue and Egg
            Residue Study of IPC in White Leghorn Chickens: IBT No. J8630B.
            (Unpublished study received on unknown date under 1F1120; pre-
            pared by Industrial Bio-Test Laboratories, Inc., submitted by
            PPG Industries, Inc., Pittsburgh, Pa.; CDL:090895-P)

00115396 Paulson, G.; Docktor, M.; Jacobsen, A.; et al. (1972) Isopropyl
            carbanilate (propham) metabolism in the chicken: Balance studies
            and isolation and identification of excreted metabolites.
            J. Agr. Food Chem. 20(4):867-876.  (Also in unpublished sub-
            mission received Oct 10, 1972 under 2F1277; submitted by PPG
            Industries, Inc., Barberton, OH; CDL:09l8l4-I)
                                   -1-
                                        101

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

00115398 PPG Industries, Inc. (1972) Propham: Residues in Various Sub-
            jects.  (Compilation; unpublished study received Oct 10,  1972
            under 2F1277; CDL:09l8l4-K)

00115^21 Terrell, Y.; Parke, G. (1977) Acute Oral Toxicity in Rats: IPC
            Technical: Laboratory No. 7E-6373.  (Unpublished study received
            Apr 26, 1978 under 748-207; prepared by Cannon Laboratories,
            Inc., submitted by PPG Industries, Inc., Barberton, OH; CDL:
            097066-3)

00115422 Quinn, R.; Paa, H. (1975) Report to PPG Industries, Inc.: Acute
            Dermal Toxicity Study with IPC Technical in Albino Rabbits: IBT
            No. 601-07378.  (Unpublished study received Apr 26, 1978 under
            748-207; prepared by Industrial Bio-Test Laboratories, Inc.,
            submitted by PPG Industries, Inc., Barberton, OH; CDL:097066-C)

00115433 Reinert, H.; Parke, G. (1975) Static 96-hour Toxicity Study of PPG
            Industries, Incorporated Sample: IPC Technical in Bluegill Sun-
            fish and Rainbow Trout: Laboratory No. 5E-8036.  (Unpublished
            study received Apr 26, 1978 under 748-207; prepared by Cannon
            Laboratories, Inc., submitted by PPG Industries, Inc., Barber-
            ton, OH; CDL:097066-Q)

00115434 Ravert, J.; Parke, G. (1977) Investigation of Teratogenic and Toxic
            Potential of IPC 50.1% ... in Rats: Laboratory No. 6E-2504.
            (Unpublished study received Apr 26, 1978 under 748-207; prepared
            by Cannon Laboratories, Inc., submitted by PPG Industries, Inc.,
            Barberton, OH; CDL:097067-A)

00115437 Burt, M.; Corbin, F. (1978) Uptake, translocation, and metabolism
            of propham by wheat ..., sugarbeet ... and ... (Medicago sati-
            va).  Weed Science 26(3):296-303.  (Also in  unpublished submis-
            sion received Jul 2, 1979 under 748-EX-15; submitted by PPG
            Industries, Inc., Barberton, OH; CDL:098350-B)

00115439 Chen, Y. (1979) Quantitative Characterization of IPC Metabolites in
            Chicken Egg: BR 21501.  (Unpublished study received Jul 2,  1979
            under 748-EX-15; submitted by PPG Industries, Inc., Barberton,
            OH; CDL:098350-D)

00115440 Paulson, G.; Jacobsen, A. (1974) Isolation and  identification of
            propham ... metabolites from animal tissues  and milk.  J. Agr.
            Food Chem. 22(4):629-631.  (Also in unpublished submission  re-
            ceived Jul 2, 1979 under 748-EX-15; submitted by PPG  Industries,
            Inc., Barberton, OH; CDL:098350-F)
                                   -2-
                                           102

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

00115441 Paulson, G.; Jacobsen, A.; Still, G. (1975) Animal metabolism of
            propham  ...: 'The fate of residues in alfalfa when consumed by
            the rat and sheep.  Pesticide Biochemistry and Physiology 5:523-
            535-  (Also in unpublished submission received Jul 2, 1979 under
            748-EX-15; submitted by PPG Industries, Inc., Barberton, OH;
            CDL:098350-G)

00115412 Smith, K. (1975) Ring-l4C-labelled Propham Egg and Tissue Residue
            Study in Laying Hens: Laboratory No. 5E-7077.  (Unpublished
            study received Jul 2, 1979 under 748-EX-15; prepared by Cannon
            Laboratories, Inc., submitted by PPG Industries, Inc., Barber-
            ton, OH; CDL:098350-1)

00115443 Still, G.; Mansager, E. (1975) Alfalfa metabolism of propham.  Pes-
            ticide Biochemistry and Physiology 5:515-522.  (Also in unpub-
            lished submission received Jul 2, 1979 under 748-EX-15; submit-
            ted by PPG Industries, Inc., Barberton, OH; CDL:098350-K)

00115446 Zurqiyah, A.; Jordan, L.; Jolliffe, V. (1976) Metabolism of isopro-
            pyl carbanilate ... in alfalfa grown in nutrient solution.
            Pesticide Biochemistry and Physiology 6:35-45.  (Also in unpub-
            lished submission received Jul 2, 1979 under 748-EX-15; submit-
            ted by PPG Industries, Inc., Barberton, OH; CDL:098350-N)

00115447 Zurqiyah, A.; Jordan, L.; Jolliffe, V. (1975) Metabolism of Isopro-
            pyl Carbanilate ... in Alfalfa. Part II—Soil Application.  (Un-
            published study received Jul 2, 1979 under 748-EX-15; prepared
            by Univ. of California—Riverside, Dept of Plant Sciences, sub-
            mitted by PPG Industries, Inc., Barberton, OH; CDL:098350-0)

00115448 Pittsburgh Plate Glass Co. (I960) A Progress Report on IPC and CIPC
            Residues in Cranberries.  (Compilation; unpublished study re-
            ceived Apr 26, 1961 under 748-EX-167; CDL:119968-A)

00115470 Hardies, D.; Studer, D. (1979) Metabolism of Isopropyl Carbanilate
            on a Hanford Sandy Loam: BR 21566.  (Unpublished study received
            Sep 17, 1979 under 748-22*4; submitted by PPG Industries, Inc.,
            Barberton, OH; CDL:240988-G)

00119929 PPG Industries, Inc. (1970) Results of Tests on the Amount of
            Residue Remaining, Including a Description of the Analytical
            Method: Propham.  (Compilation; unpublished study received on
            unknown date under 1F1120; CDL:090893-A)
                                  -3-
                                         103

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

0013^707 PPG Industries, Inc. (1973) Second Substantive Amendment to Pesti-
            cide Petition No. 2F1277 concerning Establishment of Tolerances
            for Propham on Several Crops:  Chemistry Data.   (Compilation;
            unpublished study received 1973 under 2F1277;  CDL:09l8l3-J)

00145691 Trainer, T. (1979) Isopropylcarbanllate Product Chemistry:  Techni-
            cal IPC and Chen Hoe-135 Fl-3: BR 21592.  Unpublished study  pre-
            pared by PPG Industries, Inc.   14 p.

40094602 Johnson, W.; Flnley, M. (1980) Handbook of Acute Toxicity of
            Chemicals to Fish and Aquatic  Invertebrates. USDI Publication
            137, Washington, D.C.
                                  -4-
                                          104

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                                                                              OMB Aporwtl No  XOO0468
                  FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
  PRODUCT NAME
  APPLICANTS NAME
                                                                                      DATE GUIDANCE DOCUMENT ISSUED
   Withropect lo lti«rrqu«wi*nl to B/bmil "fcnwic" oete impoicd by lh« fIFRA tection 3(CI(2)(8I nctice :onuin«d ir ii;'«'i'n-v.
   Guidtnu Document. I im rcmondino, m the following mtnntr
      D 1. .1 will ubmit d«n in I limity mwiwr 10 oiuiy thi lollowuif requimncnts. II Ihf ten procedure* I mil UK dcvutt !< noi
           tpecilxd m) rh« fl*g«tf«lion Cuidelinci or ttif Proiocoli conturad in the Reponi o( Eioert Croupi (o (nc C.i«m
-------
QMS Approval No. 30004468
INTO AN AGREEMENT WITH OTHER REGISTRANTS
[fTo qutlHy. c*TifyALL four a*ntl FOR DEVELOPMENT OF DATA
1 1. 1 «m duly «u (honied to r«ore»»nt the following firm(i) who «r« iub|ec( to the require-
ment! of i Notice und«r FlfRA Section 3tth the Notice. I undem»nd EPA win promptly inform
   me wtMttw my firm must cubmit cuta to Moid M(Mn»on of its r*otttrMion
-------
EPA Reg. No.
PRODUCT SPECIFIC DATA  REPORT



              Date
Guidance Document for
Registration
Guideline No.
§158.120
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)
Accession Numbers
Assigned


















                                          107

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Registration
Guideline No.
63-13
63-1*1
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
e>3
81-1
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flenmabillty
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage

Acute oral
toxicity, 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)
Accession Numbers
Assigned
















108

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                                               CMB Approval No. 2000-0468
                                               Expiration Date 5/31/86
                              ATTACHMENT D

                    GENERIC DATA EXEMPTION STATEMENT

 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 terras of the Notice from EPA
 dated	concerning a requirement for submission of generic data
 on  the active Ingredient named under FIFRA sec. 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, which is registered under FIFRA sec. 3,
 and which is purchased by us from another producer.

     (3)  An accurate Confidential 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 number(s) Is/are
    My firm will apply for an amendment to the registration prior to
changing the source of the active ingredient in our product.

    (U)  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 ray firm fails
to comply with the undertakings made in this Statement, my firm's product's
registration may be suspended under FIFRA sec. 3(c)(2)(B).
Registrant's authorized representative:
                                                    Signature

Dated: 		
                                                     (Typed;
                                            109

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