xvEPA
            United State*
            Environmental Protection
            Agency
            Off ice of
            Pesticides and Toxic Substance*
            Washington OC 20460
            Pesticides
                                       June 1987
Guidance for the
Reregistration of
Pesticide Products
Containing
Diphenamid
as the Active Ingredient


-------
      GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS

      CONTAINING

      DIPHENAMID
AS THE ACTIVE INGREDIENT

      CHEMICAL CODE: 036601
      CAS NUMBER:    957-51-7
      CASE NUMBER:   0269
      June 24, 1987
ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF PESTICIDE PROGRAMS

WASHINGTON, D.C.  20460

-------
                        TABLE OF CONTENTS
I.    Introduction 	  1

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

III.  Agency Assessment 	  5
        A.  Summary
        B.  Risk Concerns
        C.  Other Science Findings
        D.  Tolerance Reassessment
        E.  Summary of Label Changes and Data Gaps

IV.   Regulatory Position and Rationale	12
        A.  Regulatory Positions 	  12
        B.  Criteria for Registration	15
        C.  Acceptable Ranges and Limits 	  15
        D.  Required Labeling	16

V.    Products Subject to this Standard	18

VI.   Requirement for Submission of Generic Data	20
        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
        F.  Procedures for requesting extensions of time
        G.  Existing stocks provisions upon suspension or
            cancellation

VII.  Requirement for Submission of Product Specific Data.  26

VIII. Requirement for Submission of Revised Labeling ...  27

IX.   Instructions for Submission. 	  27
        A.  Manufacturing use products (Sole Active) ...  27
        B.  Manufacturing use products (Multiple Active) .  28
        C.  End use products	29
        D.  Intrastate products	29
        E.  Addresses	.  . . . .  30

      Glossary of Terms & Acronyms     	  iii

-------
                           APPENDICES

I.  DATA APPENDICES

    Guide to Tables

    Table A

    Table B


II.  LABELING APPENDICES

     Summary of label requirements and table

     40 CFR 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   FIFRA §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
                                 11

-------
GLOSSARY OF TERMS AND ABBREVIATIONS

1.  The Agency: U.S Environmental Protection Agency/EPA

2.  ADI: Acceptable daily intake (mg/kg/day) of a pesticide by an
       individual weighing 60 kilograms

3.  A.I.: Pes.ticide active ingredient

4   CAS: Chemical Abstract Society (number)

5   CSF: Confidential Statement of Formula

6.  DCI: Data Call-in Notice

7.  EPs: End-Use pesticide products

8.  EUP: Experimental Use Permit

9.  FIFRA:  Federal Insecticide, Fungicide, Rodenticide Act (As amended)

10. LC50: (median lethal concentration) a statistically derived
        concentration of a substance that can be expected to
        cause death in 50% 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/1 or ppm).

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

12. LEL:  Lowest Effect Level

13. MBYP: Meat byproducts of cattle, goats, hogs, horses and sheep.

14. MPs: Manufacturing-Use pesticide products

15. MPI: Maximum permitted intake of a pesticide in XX rag/day for a
       60 kg individual.

16. NOEL: No Observed Effect Level

17. NPDES Permit:  National Pollutant Discharge Elimination System

18. MRID:  Master Record Indentification (number) - EPA's system
        of  tracking studies used in support of registrations.


                            iii

-------
19. OES:  Office of Endangered Species,  U.S.  Dept.  of the Interior

20. PADI:  a provisional/temporary ADI

21. RAC's:  Raw agricultural commodities

22. Technical: Technical grade of the active ingredient

23. 40 CFR: Title 40,  Code of Federal Regulations

24. TMRC:  Theoretical  Maximum Residue Contribution for a pesticide in
       - the daily diet is based on the total tolerances in addition
         to a daily food intake of X.X kg =  X.X rag/kg.
                           iv

-------
                       I.  INTRODUCTION

              The Registration Standards Program

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

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

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

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

     The detailed scientific review, which is not contained
in this document, but is available upon request^, focuses on
     scientific reviews may be requested from: In-formation Services
Section (TS-768C),  Office of Pesticide Programs, U.S. Environmental
Protection Agency,  Room 236, Crystal Mall #2, 1921  Jefferson Davis
Highway, Arlington, Virginia  22202  (telephone (703) 557-4453).

-------
the pesticide active ingredient.  The scientific review
primarily discusses the Agency's evaluation of and conclusions
from -available data in its files pertaining to the pesticide
active ingredient.  However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient.  The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.

     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 Gancel or a Notice of
Intent to Suspend (in the case of failure to submit data).

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

-------
                           -3-


     EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit data to
answer our questions regarding the chemical, toxicological, and
environmental characteristics and fate of a pesticide.  This Regis-
tration Standard lists the data that EPA believes are necessary to
resolve our concerns about this pesticide.  These data are listed in
Table A 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.  You 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 your products
are registered by the Agency.

-------
                           -4-
          II.  CHEMICAL COVERED BY THIS STANDARD

    Description of chemical

    The following chemical is covered by this Registration
    Standard:
    Common name:
    Chemical name:
    CAS Number:
    OPP (Shaughnessy)  Number
    Empirical Formula:
    Trade Names:

    Chemical Family:
    Pesticide Type:
    Year of Initial
      Registration:
    Registrants of Technical
      Products:
 Diphenamid
 N,N-d imethyldiphenylacetamid e
 957-51-7
 036601
 C16H17NO
 Difenamid, Dymid, Enide®,
 A-831010, L-34-314
 Acetamide
 Herbicide

 1964

 Nor-Am Chemical Co.
    Description of physical characteristics of chemical:

      Diphenamid is a white to off white granular solid with a sweet
      aromatic odor at room temperature, its melting point is 133.8-
      135.4° C, and its molecular weight is 239.3.   Its solubility
      in water is 0.26 g/liter at 25°C.
B.  Use Profile

    Type of pesticide:
    Pests controlled:
    Registered Uses:
    Predominant uses:

    Mode of activity:

    Single active
     ingredient (a.i.)
    Formulations:


    Methods of application;


    Application Rates:
Selective preemergent herbicide,
Annual grasses, broadleaf weeds
Field, bush, vine & vegetable crops,
fruit, citrus fruit, cotton, green-
house & ornamental plants, and turf,
Tomatoes, tobacco, sweet potatoes
potatoes, caneberries & peppers,
Inhibition of terminal leaf and root
growth or seed germination,
97% technical,

90%, 80% & 50% (a.i.) wettable powder;
5% & 1.42% (a.i.) granular; 42.5% &
15.4% (a.i.) flowable concentrates,
Primarily applied as broadcast or
banded spray by ground or aerial
equipment,
Terrestrial food crops: 2.0 to 9.0 Ib.
a.i. per acre,
Terrestrial non-food crops: 2.0 to
6.0 Ib. a.i. per acre, ornamentals:
0.50 to 1.25 Ib. a.i. per acre.

-------
                           -5-

                    III.  AGENCY ASSESSMENT

A. SUMMARY

   The Agency has reviewed all of the data submitted to support the
   registration of diphenamid, as well as open literature infor-
   mation relevant to this compound.  Based on the review of these
   data, the -Agency has reached the following conclusions.

   Diphenamid related effects include increased liver weights and
   slight histological changes in a chronic toxicity study in dogs.
   Except for mild liver reactions in weanlings, this chemical
   does not induce reproductive effects in rats.  This pesticide
   has shown low acute oral and dermal toxicity in test animals
   and it is not an eye irritant.  It is low in avian toxicity and
   slightly to moderately toxic to fish and aquatic invertebrates.

   Although the present data base for diphenamid does not indicate
   major toxicological concerns, there are toxicology data gaps:
   including acute inhalation toxicity, primary dermal irritation,
   dermal sensitization, subchronic dermal toxicity (21-day),
   chronic toxicity (rat), oncogenicity in two species, teratology
   in two species, mutagenicity and general metabolism studies.

   In addition, the environmental fate, product chemistry, and the
   metabolism in food crops, in ruminants and poultry for this
   compound have not been characterized.

B. TOXICOLOGY

   1 . In a 2-year dog feeding study, males and females were
      offered diets containing .0, 120, 400, and 1200 ppm technical
      diphenamid in the diet for 103 weeks.  The only compound-
      related effects included slightly increased liver weights
      and slightly increased portal macrophages and/or fibroblasts
      in the livers of the dogs in the 400 and 1200 ppm dose group.
      The no-observed-effect level (NOEL) was determined to be 120
      ppm (3 mg/kg/day) in the diet.

      Available data are sufficient to satisfy the data requirements
      for chronic toxicity study in the nonrodent (dog) only.

   2. A rat feeding study was not adequate to assess chronic toxi-
      city or oncogenicity.  A chronic toxicity study and onco-
      genicity study in rats are required.  Also, a second species
      oncogenicity study (mouse) is ongoing and is expected to be
      completed in .June 1988.

-------
                           -6-

   3. Technical diphenamid was fed at dosage levels of 0,  10,  and
      30 rag/kg/day to rats of both sexes in a three generation
      reproduction study.   The only compound-related effects
      observed were mild liver reactions in the weanlings  of the
      F3 generation from the high dose group (30 mg/kg/day).
      Therefore, the NOEL for fetal effects was determined to  be
      10 mg/kg/day (200 ppm).  Since the data demonstrated absence
    •  of reproduction performance effects in treated animals at
      all the dose levels, the NOEL for reproductive effects was
      determined to be greater than 600 ppm (30 mg/kg/day) in  the
      diet.   Sufficient data are available to satisfy the  data
      requirements for a reproduction study in the rat.

   4. No teratology studies are available for technical  diphenamid.
      Teratology studies in -the rat and the rabbit are required.

   5. Diphenamid technical exhibited low acute oral toxicity [Cate-
      gory III: 1,373 mg/kg (rats, both sexes)], low acute dermal
      toxicity [Category HI: >6,320 mg/kg (rabbits, both  sexes)]
      to mammals.   It was  not an eye irritant in the primary eye
      irritation study:[Category IV - No irritation with 0.1 ml
      solution (rabbits)].

C. OTHER SCIENCE FINDINGS

   1. Human Exposure          .           -

      Major routes of exposure: Applicators (mixer/loader) handling
      this pesticide would be exposed primarily through  skin contact
      and inhalation.

   2. Physiological & Biochemical Chracteristics:

      Translocation: Diphenamid is absorbed by the roots and trans-
      located through the  roots, stem, and leaves.

      Mechanism of pesticidal action: It inhibits growth in terminal
      leaves and roots.

      Metabolism & Persistence in Plants & Animals: The  available
      data are inadequate  to evaluate the persistence of diphenamid
      in plants and animals.

   3. Environmental Fate

      The Agency does not  have sufficient data to fully  assess the
      environmental fate of diphenamid.

-------
                        -7-

   a. Ground Water

      A ground water Data Call-in Notice was issued for
      diphenamid.  The data received were insufficient to fully
      assess the leaching potential of parent compound and
      metabolites in a variety of soils.  However, available
      studies indicate that this compound is mobile in a silty
      clay loam soil, and is relatively stable to hydrolysis and
      may leach to ground water supplies.

   b. Degradation

      The Agency does not have sufficient data to fully assess
      the degradation of diphenaraid.

   c. Forestry Uses

      Since the registrant has voluntarily deleted the forestry
      use pattern for diphenamid products, an anaerobic aquatic
      metabolism and a forestry dissipation study which would
      have been required under forestry uses will not be required
      in this Standard.

4. Ecological Effects

   There is sufficient information to characterize technical
   diphenamid as slightly toxic to freshwater invertebrates:
   Daphnia magna (LC5Q of 58.0 ppm).  There is sufficient infor-
   mation to characterize formulated diphenamid as having very
   low toxicity on avian dietary basis: Bobwhite quail (LC^Q of
   18,000 and Mallard duck (LC5p of 30,000 ppm).  However, an
   avian single-dose oral toxicity study and an avian dietary
   toxicity study in two species using technical diphenamid are
   required.  There is sufficient information to characterize
   formulated diphenamid as being slightly toxic to warmwater
   fish: Bluegill (LC5Q of 32.0 ppm) and moderately toxic to
   coldwater fish: Rainbow trout (1,050 of 1.2 ppm).  However, a
   freshwater fish toxicity study in two species using technical
   diphenaraid is required.  In an acute contact study, diphenamid
   was shown to be very low in toxicity to honey bees.

   Hazard assessments were conducted for terrestrial and aquatic
   organisms in which hypothetical environmental concentrations
   were compared to lethal concentrations (LC5o) and lethal
   dosages (1059) of the pesticide.  Acute concerns were not
   triggered for mammals, birds, or fish.

   Since the registrant has voluntarily deleted the forestry use
   pattern for diphenamid products, endangered species labeling
   which would have been required under forestry uses will not
   be required in this Standard.

-------
                           -8-


D.  TOLERANCE REASSESSMENT

   According to 40 CFR 180.230,  tolerances, for diphenaraid have been
   approved for the raw agricultural commodities (RAC's)  listed
   below.

   Crop                 Tolerance(ppm)

   Apples                   0.10
   Cattle, fat             0.05
   Cattle, meat            0.05
   Cattle, mbyp            0.05
   Cottonseed              0.10
   Cotton forage           0.20
   Fruiting vegetables     0.10
   Goat,  fat               0.05
   Goat,  meat              0.05
   Goat,  mbyp              0.05
   Hogs,  fat               0.05
   Hogs,  meat              0.05
   Hogs,  mbyp              0.05
   Horses, fat             0.05
   Horses, meat            0.05
   Horses, mbyp            0.05
   Milk                    0.01
   Okra                    0.10
   Peaches                 0.10
   Peanuts                 0.10
   Peanut, hay & forage    2.00
   Peanut hulls            0.50
   Potatoes                1.00
   Raspberries             1.00
   Sheep,  fat              0.05
   Sheep,  meat             0.05
   Sheep,  mbyp             0.05
   Strawberries            1.00
   Soybeans                0.10
   Soybean, hay & forage   0.50
   Sweet  potatoes          0.10

-------
                         -9-

 The Provisional Acceptable Daily Intake (PADI)  for diphenamid is
 based on the 103 week dog feeding study with a  NOEL of 120 ppm
 (3 rag/kg/day).   Other toxicology data considered  in suport of these
 tolerances  include a 3-generation rat reproduction study  indicating
 that reproductive performance was not affected  at  dietary intake up
 to and including 30 mg/kg/day.   Utilizing  a  safety factor of  100,
 the PADI was calculated  to be  .03 mg/kg/day.

 The Agency  examined the  dietary  burden of  diphenamid using the
 Tolerance Assessment System (TAS),  a  dietary exposure  data base.
 TAS allows  the  Agency, using either known  residue  levels  or
 tolerance levels  in raw  agricultural  commodities to determine
 the average  and  range  of  exposure  to  pesticide  residues for the
 general  population and twenty two  subpopulations based on known
 patterns  of  food  consumption.  The  theoretical  dietary exposure
 expressed as  a  percentage  of PADI utilized by the  Theoretical
 Maximum  Residue  Contribution (TMRC) ranged from 3.8% to 11.8%
 of  the PADI  for  various subgroups with  5.6%  being  the U.S.
 population average.

 Additional data  are  required for  plant  and animal  metabolism,
 analytical methods,  and storage stability.   Processing studies
 are required  for  potatoes,  soybeans,  tomatoes,  apples, cotton-
 seed  and peanuts.   Since the data required for  individual  commo-
 dities .are dependent on .metabolism  data, the Agency recommends
 that  metabolism  data be obtained and  submitted  prior to any
 required residue  data.

 There  is a Canadian  tolerance of  1.0  ppm for diphenamid residues
 in  or  on strawberries, but no Canadian  tolerances  exist for
 residues of diphenamid on the other raw agicultural commodities
 listed in 40 CFR  180.230.  There are no Mexican tolerances  or
 Codex Maximum Residue Levels for residues of diphenaraid on  the
 raw agicultural commodities listed  in 40 CFR 180.230. •

 Existing tolerances  for soybean hay and forage;  and peanut  hay
 are adequately supported by data.  Therefore, a proposal  to
 remove the grazing and feeding restrictions currently in  effect
 for diphenamid products in soybeans and peanuts  would be  approved
by  the Agency.

Reported Pesticide Incidences

The Pesticide Incident Monitoring System (PIMS.)  does not have
any incident involving diphenamid at this time.   Based upon data
 from California,  five incidences indicating skin or eye irritation
occurred from 1981 through 1985.   Although four  of the incidences
 involved applicators and one involved a non applicator, none of
these cases  required hospitalization.

-------
                           -1C-

E.  SUMMARY OF LABEL CHANGES AND DATA GAPS

    The Agency has determined that label revisions must be made
    in the following areas (See Section D, Part IV).

      0 Environmental Precautions
      0 Ecological Effects

    The Agency has identified data necessary to evaluate the envi-
    ronmental and human risks associated with the use of diphenamid.
    These data must be developed in order to maintain registrations
    of products or register new products containing diphenamid.
    The following table summarizes the data gaps, including product
    chemistry information.  Please note that this is  only a summary
    and details can be obtained by referring to Table A.

       Summary of Data Gaps - Diphenamid

      158.120 Product Chemistry

          All of the Product Chemistry data are required.

      158.125 Residue Chemistry:

          171-4 Nature of Residue (Plant & Animal Metabolism)
          171-4 Residue Analytical Methods
          171-4 Storage Stability
          171-4 Residue Studies on Crops
          171-4 Residue Studies on Processed Food/Feed
                  Commodities

      158.135 Toxicology:

          81-3   Acute Inhalation Toxicity (Rat)
          81-5   Primary Dermal Irritation (Rabbit)
          81-6   Dermal Sensitization (Guinea pig)
          82-2   Subchronic Dermal (21-day)
          83-1   Chronic Toxicity (Rat)
          83-2   Oncogencity (Two species)
          83-3   Teratogenicity (Two species)
          84-2   Mutagenicity
          85-1   Metabolism

      158.130 Environmental Fate

          161-2  Photodegradation in Water
          161-3  Photodegradation in Soil
          162-1  Aerobic Soil Metabolism
          162-2  Anaerobic Soil Metabolism

-------
                     -11-

158.130 Environmental Face

    163-1  Mobility Studies-Leaching & Adsorption/
             Desorption
    163-2  Mobility Studies-Volatility (Lab)
    164-1  Soil Dissipation
    165-1  Rotational Crops (Confined)
    165-4  Accumulation in Fish

158.145 Wildlife and Aquatic Organisms

    71-1    Avian Acute Oral Toxicity
    71-2   Avian Dietary Toxicity
             (Two species)
    72-1    Freshwater Fish Acute Toxicity
             (Two species)
    122-2  Aquatic Plant Growth

-------
                           -12-

IV. REGULATORY POSITION AND RATIONALE

A. Regulatory Positions

Based on a review and evaluation of all available data and other
relevant information on the herbicide diphenamid, the Agency has
reached the following determinations.

   1. The Agency will not place diphenamid in Special Review.

    Rationale: Diphenamid does not exceed the risk criteria for
      adverse effects in 40 CFR, Section 154.7.

      Available data indicate that Diphenamid does not pose a risk
      of serious acute injury to humans, avian species and aquatic
      organisms.  In a chronic toxicity study of diphenamid in dogs,
      data indicated no adverse chronic liver effects at the 400 ppra
      (10 mg/kg/day) dosage level.  Except for mild liver reactions
      in weanlings in the third generation of a reproduction study
      in rats, this compound does not induce reproductive effects
      in rats.

   2. The Agency has determined that certain toxicological studies
      are required to support the reregistration of diphenamid
     -products.

    Rationale: The Agency does not have the following data on
      diphenamid which are required to meet Agency guidelines for •
      toxicological testing necessary to support its registration:
      acute inhalation toxicity, primary dermal irritation, dermal
      sensitization, subchronic dermal (21-day), chronic toxicity
      in rats, oncogenicity in two species, teratology in two
      species, mutagenicity and and metabolism studies.

   3. The Agency has determined that present precautionary statements
      for persons handling or applying diphenamid products are
      sufficient for the labels of manufacturing-use and end-use
      products.

    Rationale: Available data indicate that diphenamid causes low
      acute oral (Category III) and acute dermal (Category III)
      toxicity in test animals and it is not an eye irritant (Cate-
      gory IV).  The labeling of these products contains statements
      that provide precautionary measures to ensure safe handling
      of the pesticide products and provides the user with first
      aid instructions.

-------
                         -13-

4. The Agency will require certain environmental fate data.

 Rationale: The Agency does not have the following environmental
   fate data necessary to support the reregistration of diphena-
   mid: photodegradation in water and soil, mobility (leaching &
   adsorption/desorption) mobility [volatility (lab)], soil
   dissipation, rotational crops (confined) and accumulation in
   fish studies.

5. The Agency has determined that certain groundwater data are
   required.

 Rationale: The Agency evaluated the data submitted in response
   to the May 1984, Ground Water Data Call-in for Diphenamid,
   and found them to be inadequate to fully assess the potential
   of diphenamid to reach ground water supplies.

   However, available data indicate that diphenamid is mobile  in
   a silty clay-loam soil,  and relatively stable  to hydrolysis,
   and may leach to ground  water.

   The necessary environmental fate data (aerobic and  anaerobic
   metabolism studies)  are  being repeated at the  present time.
   The Agency expects to  receive these data by July 1987.   Until
   these data are received  and found  acceptable by the Agency,
   data gaps for ground water exist.

6.  The Agency has determined that  reentry data are not required
   for diphenamid at this time.

 Rationale:  The low acute  toxicity of this chemical does  not  war-
   rant significant concern about  exposure of workers  reentering
   treated areas, according to the criteria in 40 CFR Part 158.140,
   Diphenamid has been  determined  to  be low in acute oral, and
   dermal toxicity, and it  is not  an  eye irritant.

7.  The Agency has determined that  certain residue chemistry data
   are required.

 Rationale: The Agency  does not  have  the following residue chemis-
   try data necessary to  support the  reregistration of diphenamid:
   plant and animal metabolism,  analytical methods, storage
   stability, and processing studies  for potatoes,  soybeans,
   tomatoes, apples,  cottonseed  and peanuts.

-------
                          -14-

 8.  The Agency has determined that grazing and feeding restrictions
    for soybean hay and forage,  and peanut hay are not required
    for diphenamid products.

  Rationale:  Existing tolerances for soybean hay and forage;  and
    peanut hay are adequately supported by residue chemistry  data.
    Therefore, EPA will approve  removing the grazing and feeding
    restrictions currently in effect for soybeans and peanuts if
    the registrants propose it.

 9.  The Agency has determined that endangered species labeling is
    not required in this standard.

  Rationale:  The registrant has  voluntarily deleted the forestry
    use pattern for diphenamid products.  Therefore, endangered
    species labeling which would have been required under forestry
    uses will not be required in this standard.

10.  The available data indicate  that this pesticide, when applied
    at recommended rates,  does not present unreasonable hazards  to
    birds.

  Rationale:  Existing studies on a formulation of this chemical
    indicate  that its dietary toxicity to avian species is very
    low.

11.  While the data gaps are being filled, currently registered MPs
  • and EPs containing diphenamid as the sole active ingredient
    may be sold, distributed, formulated and used in the United
    States, subject to the terms and conditions specified in  this
    Standard.  Registrants must  provide and agree to develop
    additional data, as specified in the Data Appendices of this
    guidance  document, in order  to maintain existing registrations.

  Rationale:  Under FIFRA,  the Agency does not normally cancel
    or withhold registration simply because data are missing
    or inadequate (see FIFRA sec. 3(c)(2)(B) and 3(c)(7)).

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

-------
                           -15-

B.  Criteria for Registration

To be registered or reregistered under this Standard, manufacturing-
use products must contain diphenamid 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.

C.  Acceptable Ranges and Limits

    1.   Product Composition Standard

To be covered under this Standard, manufacturing-use products (MPs)
must contain diphenamid as the sole active ingredient.  Each iMP
formulation proposed for registration must be fully described with
an appropriate certification of limits, stating maximum and minimum
amounts of the active ingredient which may be present in products.

    2.   Acute Toxicity Limits

The Agency will consider registration of technical grade and MP
products containing diphenamid, 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, manufacturing use products
containing diphenamid must be labeled for formulation into end-use
products only for the commodities listed below.  The EPA Index to
Pesticide Chemicals for Diphenamid lists all registered uses, as
well as approved maximum application rates and frequencies.

 0 Terrestrial food uses on apples, cotton, peaches, black and red
   raspberries, okra, peanuts, peppers, potatoes, soybeans, straw-
   berries, sweet potatoes, tomatoes, on non-bearing blackberry,
   blueberry, cherry, lime, orange, and raspberry plants.

 0 Terrestrial nonfood uses on tobacco, ornamental plants, nursery
   seed crops, hardwood, tobacco seedbeds, and turf.

-------
                           -16-

D.  Required Labeling

All manufacturing-use and end-use diphenaraid products must bear
appropriate labeling as specified in 40 CFR 162.10,- and below.
Appendix II contains information on label requirements.

No pesticide products containing diphenamid may be released for
shipment by a registrant or producer of that product after July 30,
1988, unless the product bears an amended label which complies  with
the requirements of this Standard.

No pesticide products containing diphenamid may be distributed,
sold, offered for sale, held for sale, shipped, delivered for
shipment, or received and (having been so received) delivered or
offered to be delivered by any person after July 30, 1989, unless
the product bears an amended label which complies with the require-
ments of this Standard.

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

    1.  Ingredient Statement

The ingredient statement for all manufacturing-use products contain-
ing diphenamid products must list the active ingredient in the
following manner (example):

        Diphenamid (N,N-dimethyldiphenylacetamide)	%" ;

    2.  Use Pattern Statements

All manufacturing-use products containing diphenamid must state
that they are intended for formulation into end-use products for
only the aforementioned 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 comply with
the data requirements listed in Table A for that use pattern.

-------
                       -17-

3.   Precautionary Statements

    a. Manufacturing-Use Product Statements

       All diphenamid products intended for formulation into
       end-use products must bear the following statements:

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

    b. End-Use Product Statements

       The following precautionary statements must appear on the
       following diphenamid EP labels:

       1.  (Non-granular)

       "  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."

       2.  (Granular)

       "  Cover, incorporate or collect  granules spilled on the
       soil surface.   Do not contaminate  water by  cleaning of
       equipment or disposal of wastes."

-------
                             18

            V.  PRODUCTS SUBJECT TO THIS STANDARD

     All produces 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
formulator1s 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.

-------
                             1,9

 B.   Manufacturing use products containing this pesticide
 as  one  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 exemption^,  the
      data requirements listed in'Table C.

      3.  If not eligible for the formulator1s exemption, the
      data requirements listed in Table A and the data require-
      ments listed in Table C.

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

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

      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.

-------
                             20

       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.^

 A.  What are generic data?

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

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

 B.  Who must submit generic data?

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

     If you are granted a generic data exemption, you  rely on
 the efforts of other persons to provide  the Agency with the
 required data.  If the registrants who have committed  to
 generate and submit the required data fail to  take appropriate
 steps to meet the requirements or are no longer  in compliance
 with this data requirements notice,  the  Agency will  consider
 that both they and you are not in compliance  and will  normally
 initiate proceedings to suspend the  registrations of both
 your product(s) 'and their product(s) unless you  commit to submit
 and submit the required data in the  specified  tiraeframe.  In
 such cases, the Agency generally will not  grant  a  time extension
 for submitting the data.
4 Registrations granted after  issuance  of  this  Standard will
be conditioned upon submission or  citation of the data listed
in this Registration Standard.

-------
                                  21


      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
 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 FIFRA sec. 3(c)(7)(A).  If you thereafter fail
 to  comply  with the condition of that registration to provide
 data, the  registration may be cancelled (FIFRA sec. 6(e)).

 C.  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 157
 developing) the data, but 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.

-------
                                22


 The Agency will also require adequate assurance chat 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 terras 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:

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

      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:

-------
                                    23

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

 The  remainder of  your offer may not in any way attempt to
 limit  this  commitment.  If the other registrant to whom your
 offer  is made does not accept your offer, and if the other
 registrant  informs us on a DCI Summary Sheet that he will
 develop  and submit the data required under the DCI, then you
 may  qualify for  this option.  In order for you to avoid
 suspension  under  this method, you may not later withdraw or
 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 as required by this
 Notice in a timely manner.  If the other registrant fails to
 develop  the data  or for some other reason would be subject to
 suspension, your  registration as well as that of the other
 registrant will normally be subject to initiation of suspension
 proceedings, unless you commit to submit and submit the required
 data in -the specified timefrarae.  In such cases, the Agency
 generally will not grant a time extension for submitting the data.

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

     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.

-------
                                   24

 E.  Testing Protocols,  Standards  for Conducting Acceptable
     Tests, Guidance on  Evaluating and  Reporting Data.

     All studies required under  this Notice  must be conducted
 in accordance with test standards outlined  in  the Pesticide
 Assessment Guidelines,  unless other protocol or standards are
 approved for use by the Agency  in writing.

     As noted herein,  these  EPA  Guidelines,  which are  referenced
 in the Data Tables, are available from the  National Technical
 Information Service (NTIS),  Attn:  Order Desk,  5285 Port  Royal
 Road,  Springfield, VA  22161 (tel:  703-487-4650).

     Protocols approved  by the Organization  for Economic
 Cooperation and Development  (OECD)  are also acceptable  if
 the OECD-recommended  test standards conform to those  specified
 in the Pesticide Data Requirements  regulation  (Part 158.70).
 Please note, however, that  certain  OECD standards  (such  as
 test duration,  selection of  test  species, and  degradate
 identification  which  are environmental fate requirements) are
 less restrictive than those  in  the  EPA Assessment  Guidelines
 listed above.  When using the OECD protocols,  they should be
 be modified as  appropriate  so that  the data generated by the
 study.will satisfy the  requirements of Part 158.   Normally,
'the Agency will not extend  deadlines  for complying with  data
 requirements when the studies were  not conducted  in accord
 with acceptable standards.   The OECD  protocols are available
 from OECD, 1750 Pennsylvania Avenue,  N.W.,  Washington,  D.C.
 20006.

 F.   Procedures  for requesting a change in testing  protocol.

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

      You should submit  your  protocols  before beginning  testing,
 because the Agency will not  ordinarily accept  as  sufficient
 studies using unapprbved protocols.   A request for protocol
 approval will not extend the timefrarae for  submission of the
 data,  nor will  extensions generally be given to conduct
 studies due to  submittal of  inappropriate protocols.


 G.   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

-------
                                  25

 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  by  the 90-day 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 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  data submission 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.

     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.

 H.   PR Notice  86-5 and Any Other Requirements Referenced or
     Included Within this Notice.

     All  data  submitted in response to this Notice must comply
 with EPA requirements regarding the reporting of data,
 including the manner of reporting, the completeness of results,
 and  the  adequacy of any required supporting (or raw) data,
 including, but not limited to, requirements referenced or
 included in this Notice or contained in PR Notice 86-5 (issued
 July 29, 1986).

 I.   Existing  stocks provision upon suspension or cancellation.

     The Agency  has determined that if a registration  is
 suspended for  failure to respond to a DCI request under
 FIFRA sec. 3(c)(2)(B), an existing stocks provision  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

-------
                                  26

 such  permission would be consistent with the Act.   The following
 information must be  included in any request for an existing
 stocks  provision:

      1.  Explanation of why an existing stocks provision is
      necessary, including a statement of the quantity of
      existing stocks and your estimate of the time required
      for their sale or distribution; and

      2.  Demonstration that such a provision would be consis-
      tent with the provisions of FIFRA.


   VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA

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

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

      In order to comply with the product specific data require-
 ments, you must follow the same procedures as for generic  data.
 See Section VI. D, E, F, and G.  You should note, however,  that
 product chemistry data are required for every product, and the
 only acceptable responses are options VI.D.1. (submit data)
 or VI.D.6.(cancellation of registration).

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

-------
                                -27

    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 CFR 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 40 CFR 162.10 and the specific  instructions
in Section IV.D.,  EPA may seek to cancel or suspend  the
registration of your product under FIFRA sec. 6.


               IX.  INSTRUCTIONS FOR SUBMISSION

A.  Manufacturing Use Products (MUPs) containing Diphenamid  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)(1)(D).  Refer to 40 CFR
    152.80-152.99.
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

-------
                                   28
     2.  Within 9 months from receipt of this document you
must  submTttothe 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).

     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 forniulator'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 Dlphenamid in combi-
    nation 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
    attachments^ (EPA Form 8580-1).

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

        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 forraulator'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.

-------
                                     29
C.  End Use Products containing Diphenamid as  the 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^ (EPA Form 8580-1).

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

        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 8580-4),
    if Table C lists required product-specific data.

    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  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 Diphenamid 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.

-------
                                   30
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 Assurance Division
     Office of Compliance Monitoring (EN-342)
     Environmental Protection Agency
     401  M St.,  SW
     Washington, D.C. 20460.

-------
                           TGUIDE-1    3 1

                       GUIDE TO TABLES

     Tables A and B 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.

     The data tables are generally organized according to the
 following format:

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

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

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

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

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

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

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

-------
                                 3?
                                 W 4—

                           TGUIDE-2

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

      YES  -  EPA  has  data  in its  files that satisfy this data
      requirement.   These data may be cited by other registrants
      in accordance  with data compensation requirements of
      Pirt  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 Itaster Record
Identification  (MRID)  number, but may be a>GS number if no
MRID  number  has been assigned.  Refer  to the Bibliography
Appendices for  a complete citation of  the study.

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

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

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

-------
                                             TA1M.K A

       GENERIC DATA REQUIREMENTS TOR DIPHENAMID 97% TECHNICAL3 (EPA REG. NO. 45639-127)
                                                   DRAFT
Data Requirement
§158.120 Product Chemistry
Product Identity and Composition:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product
Samples
62-2 - Certification of Ingredient
Limits
62-3 - Analytical Methods to Verify
Certified Limits
Physical and Chemical Characteristics
•••« 63-2 - Color
63-3 - Physical State
^ 63-4 - Odor
Osl
63-5 - Melting Point
63-6 - Boiling Point
Test
Substance



TGAI

TGAI

TGAI



TGAI
TGAI
TGAI

TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns



All

All

All



All
All
All

All
All
All
All
All
Does EPA
Have Data?



No

No

No



No
No
No

No
No
No
No
No
Bibliographic
Citation1



N/A

N/A

N/A



N/A
N/A
N/A

N/A
N/A
N/A
N/A
N/A
Must Addtl
Data be
Submitted?



Yes 21

Yes 3/

Yes 4/



Yes J>/
Yes 6/
Yes TJ

Yes 8/
Yes 8/
Yes 8/
Yes 8/
Yes 8/
Time Frame
for
Submission



6 Months

6 Months

6 Months



12 Months
12 Months
12 Months

6 Months
6 Months
6 Months
6 Months
6 Months
63-7 - Density, Bulk Density, or
       Specific Gravity
TGAI
All
                                                      No
                               N/A
                                                                                 Yes 8/
                                                6-Months

-------
                                                      TAHLK A

          GFNFR1C LttTA  RtiQUIKblflWrs FOR DIPHKNAMID, 97% TI-'.CHNICAl.a (HPA RF.G.  NO. 45639-127)
 Data Requirement
Test         Use        Does  EPA      Bibliographic
Substance    Patterns   Have  Data?    Citation^
 Other Requirement:
 64-1- Submittat of samples
 N/A
No
                                Mist Addtl  Time Frame
                                Data be      for
                                Submitted?  Submission
§158.120 Product Chemistry (Continued)
63-8
63-9
63-10
63-11
63-12
63-13
- Solubility
- Vapor Pressure
- Dissociation Constant
- Octanol/Water Partition
Coefficient
- PH
- Stability
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
Yes 8/
Yes JB/
Yes 8/
Yes 8/
Yes &/
Yes 8/
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
No  9/
ON)

-------
                                                     TABLE A
         GENERIC  CftTA REQUIREMENTS FOR DIPHENAMID, 97% TECHNICAL3 (EPA REG. NO. 45639-127 )

§158.120 Product  Chemistry  (Continued)

 a  The 97% technical serves as a manufacturing-use product.

 J/ Not applicable.  Although product chemistry data may have been submitted in the past, the Agency has determined  that
 ~~  certain data  must be resubrnitted for each pesticide.  New requirements have been introduced and previously
    submitted  data must be updated.  The bibliographic citations for old data are not applicable.
 2/ The name of each impurity present at >0.1% must be reported.
 y Complete information must be provided regarding the nature of the process (batch or continuous) , the
    relative amounts of beginning materials and the order in which they are added, a flow chart with chemical
    equations  for each intended reaction, equipment used to produce the product, reaction conditions, the duration
    of each step  of the process, purification procedures, and quality control measures.  In addition, the name and
    address of the manufacturer, producer or supplier of each beginning material must be provided, along with
    information regarding the properties of each beginning material used.
 4/ A detailed discussion of all impurities that are or may be present at X).1%, based on knowledge of the beginning
    materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during  and
    after production must be submitted.
 _5/ Five or more  representative samples must be analyzed for the anount of active ingredient and toxicologically  signi-
    ficant  inerts.  Complete validation data (accuracy, precision) must be submitted for each analytical method used.
    In addition,  all nitrosamines must be identified and quantified in six samples; two samples of each must be
    analyzed shortly after production, 3 months after production, and 6 months after production.
 6/ Upper and  lower limits for diphenamid must be provided, certified, and validated by sample analysis using ana-
    lytical procedures for which accuracy and precision data have been provided.  Upper limits for each impurity
    present at X). 1% (w/w) , and for each "toxicologically significant" impurity present at <0.1% (w/w) must be
    provided,  certified, and validated by sample analysis using analytical procedures for which accuracy and precision
    data have  been provided.  Certifications must be submitted on EPA Form 8570-4, Rev. 2-85.
 TJ Analytical methods must be provided to determine the active ingredient and each toxicologically significant
    impurity for  vfaich a certified limit is required.  Each method must be accompanied by validation studies
    indicating its accuracy and precision.  These methods must be suitable for enforcement of certified limits.
 8/ All physicochemical characteristics of the 97%T (EPA Reg. No. 45639-127) (i.e. , color, physical state, odor,
    melting point, specific gravity, solubility, vapor pressure, pH, and stability) or the pure active ingredient
    (Row),  as  required in 49 FR 42890 (Sec. 158-120) and more fully described in the Pesticide Assessment Guideline
    Subdivision D, must be submitted.

 9/ The compound  does not require submission of samples at this time.

-------
                                                       TAKI.K A
                                       GF-NliRIC LV\TA RB^UIRFMENTS FDR DIHHENAMID
  Data Requirement
 Test
 Substance
Does FPA     Bibliographic
Have Data?   Citation
                      Must Addtl  Time  Frame
                      Data be       for
                      Submitted?  Submission
  §158.125 Residue Chemistry

 171-4 - Nature  of Residue
          (Metabolism)

         - Plants
         - Livestock
 171-4  - Residue Analytical
        Method

       - Plant residues
      - Animal Residues
 PAIRA
PAIRA & Plant
Metabolites
TGAI &
Metabolites
TGAI
Partially
                                                         No
                                                         Partially
                                                         No
00093608. 00114601
00093609. 00114613
40200701
             00035605. 00114570
             00043703. 00114586
             00106180. 00114590
                                                                                              Yes 1/2/     18 Months
                                     Yes 3/4/
                        Yes 5/6/
                                                                                              Yes 5/6/
                                    18 Months
15 Months
                                                                         15 Months
 171-4 - Storage Stability Data    PAI
 171-4 - Magnitude of the Residue -
          Residue Studies

        a. Root & Tuber Vegetables 9/

  '•3        ° Potatoes
  _        — Crop Field Trials     TfcP

           -- Processed  Food/Feed   KP
ON
                       Partially    00035601,00093614     Yes 7/87     15  Months
                                    00035602. 00114577         	
                                    00035603.. 00114585
                       Partially

                       No
            00114577.  00114601
            00114588,
                       Yes _K)/

                       Yes  11/
18 Months

24 Months

-------
                                                       TABLE A
                                       GENERIC DATA REQUIREMENTS TOR DIPHENAMID
 Data Requirement
Test
Subs tance
Does EPA     Bibliographic
Have Data?   Citation
Must Addtl
Data be
Submitted?
Time Frame
 for
Submission
§158.125 Residue Chemistry -  Continued

171-4 - Magnitude of the  Residue  -
          Residue Studies

           0  Sweet Potatoes
           — Crop Field  Trials     TEP
       b.  Legume  Vegetables  12/

           0  Soybeans
           — Crop Field Trials     TEP
           -- Processed Food/Feed   EP

       c.  Fruiting Vegetables
           (Except Cucurbits)

           0  Peppers
           -- Crop Field Trials     TEP

           0  Tomatoes
           -- Crop Field Trials     TEP
          — Processed Food/Feed   EP

       d. Pome Fruits 16/

          0 Apples
          — Crop Field Trials     TEP
          -- Processed Food/Feed   EP
                   Yes
                   Yes
                   No
                   Partially


                   Yes


                   No
             00035596, 00073539
             00035649
             00035643, 00114566
             00114585
             00105710, 00114601
             00106180, 00138452
             00114570
                   Partially    00035607, 00035612
                   No
No
No
Yes 13/
Yes 14/
No
                                      Yes  15/
                                      Yes  \TJ
                                      Yes  18/
                                                      24 Months
18 Months
                                                                         24 Months
                18  Months
                24  Months

-------
                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FDR DIPHENAMID
 Data Requirement
                                   Test
                                   Subs tance
Does EPA     Bibliographic
Have Data?   Citation
 Mist Addtl
 Data be
 Submitted?
Time  Frame
 for
Submission
§158.125 Residue Chemistry - Continued

171-4 -  Magnitude of the Residue -
          Residue Studies

        e. Stone Fruits 19/

          0 Peaches
          — Crop Field Trials     TEP

        f. Small Fruits & Berries 20/

          0 Raspberries
          — Crop Field Trials     TEP
          0 Strawberries
          -- Crop Field Trials     TEP

       g. Miscellaneous Commodities

            Cottonseed
          -- Crop Field Trials     TEP
          — Processed Food/Feed   EP

          0 Okra
          — Crop Field Trials     TEP

            Peanuts
          -- Crop Field Trials     TEP
CM
OO
          -- Processed  Food/Feed    EP

            Tobacco
          — Crop Field Trials      TEP
          -- Processed              |?p
                                                      Yes
                                                      Yes
                                                      Yes
                                                      No
                                                      Yes
                                                      Yes
                                                      No
                                                      No
                                                      No
             00035610.
                                                      Partially    00029335.  00114602
             00093614, 00114594
             00035608
             00035609,  00114600
                                                                   00026700, 00035611
                                                                   00031791, 00035647
                                                                   00035595,
No
Yes _21_/


No
No
Yes 22/
                                                                                             No
                                                                                             No
                                                                                             Yes 23/
                                      Yes  24/
                                      Yes  25/
                                                                                                             18 Months
                                                                                                             24 Months
                                                      24 Months
                18 Months
                24 Months

-------
                                                      TABLE A
                                      GENERIC DATA RHQUIREMENTS -FDR DIPHENAMID
Data Requiranent
Test
Subs tance
Does EPA
Have Data?
Bibliographic
Citation
Must Addtl
Data be
Submitted?
Time Frame
for
Submission
§158.125 Residue Chemistry -  Continued

171-4 - Magnitude of  the Residue  -
         Residue Studies
        d.  Meat/Milk/
           Poultry/Eggs

      -  Potable Water

      -  Fish

      -  Irrigated Crops

      -  Food Handling
TGAI or Plant
Metabolites

TEP

TEP

TEP

TEP
Partially    00114586


No

No

No

No
Reserved  26/


No 22J

No 27 /

No _27/_

No 27/

-------
                                                     TABLE A
                                    GENERIC DATA  RtQUIRtMENTS TOR  DIPHENAMID

§158.125 Residue Chemistry - Continued

     I/ Data must be submitted depicting the uptake, distribution,  and metabolism of ring-labeled [I^Cjdiphenamid  (or
     ~  carbon  labeled [ I^C]diphenamid)  in  potatoes  following preemergence or layby applications, and in tomatoes
        following broadcast or band treatment one  month  after direct  seeding  or transplanting at a rate sufficiently
        high to permit complete ^-residue identification.  Plants must be harvested for residue characterization at
        regular intervals until maturity.

     2J Representative samples from the  requested  plant metabolism  studies must also be analyzed using accepted
     ~    enforcement methods to ascertain that these methods will determine all possible metabolites of concern.

     3/ Metabolism studies must be submitted utilizing ruminants and  poultry.  Animals must be dosed for three days
     ~~  with ring-labeled [ 1/tC]diphenaroid at a level sufficient to  make residue identification and quantification
        possible.  Milk and eggs must be collected twice daily during the dosing period.   Animals must be sacrified
        within  24 hours of the final dose.   The distribution and characterization of residues must be determined in
        milk, eggs, liver, kidney, muscle,  and fat.

     kj Representative samples from the  requested  animal metabolism studies must also be analyzed using accepted
        enforcement methods to ascertain that these methods will determine all possible metabolites of concern.

     _5/ Residues of MM in or on crop samples must be  subjected to  analysis by multiresidue protocols.
        Protocols for Methods I, II, III, and IV are available from National  Technical Information Service
        under Order No. PB 203734/AS.

     6/ Additional methods, validation data, and residue data (for  representative commodities) may be required
        if the  metabolism studies requested in footnotes 4 and 6 indicate that additional metabolites may
        constitute residues of toxicological concern in  plants or animals.

 '    T_l The  storage intervals and conditions of storage  of samples  used to support all established
        tolerances for residues of diphenamid including  its desmethyl metabolite must be submitted.
        These data must be accompanied by data depicting the percent  decline  in residues at the time and
^       under the conditions specified.  On receipt of these data,  the adequacy of the aforementioned
        tolerances will be reevaluated.

     &/ All  residue data requested in this  Standard must be accompanied by data regarding storage intervals
        and  conditions of sample storage.   These data  must be accompanied by  fortification recovery data
        depicting the stability of diphenamid residues of concern in  appropriate sample substances under
        the conditions for the time intervals specified.

-------
 D1PMJNAM1I)

 §158.125 Residue Chemistry  - Continued

     9/ If the registrant socks a crop group tolerance, tolerances and use directions must he proposed,  and
     ~  supporting residue  data submitted for additional representative group members (carrot, radish, and  sugar
        beet).

    10/ Data must be  submitted depicting residues of concern in or on potatoes harvested 50 days following  preemergence
    ~~  broadcast application (in at least 30 gal water/A) , and, in separate tests, layby application of the 50 or 90%
        WP formulation at 6 Ib ai/A.  Tests must be conducted in ID(24%),  ME(6%) , and WA(16%), states which are repre-
        sentative of  the major U.S. potato production regions (Agricultural Statistics, 1985, p. 164).

    11/ Data must be  submitted depicting diphenamid residues of concern in or on granules, dried peels and  dried
        chips processed from potatoes bearing measurable weathered residues.  It may be necessary to use exaggerated
        rates to achieve such residues.  If residues are found to concentrate in any processed product,  appropriate
        food/feed additive  tolerances must be proposed.

    ]2/ If the  registrant seeks a crop group tolerance, use directions must be proposed, and appropriate supporting
        residue data  submitted for the additional representative group members beans (succulent and dry)  and peas.

    13/ Data must be  submitted depicting diphenamid residues of concern in hulls, crude oil, refined oil, meal, and
        soap stock processed from soybeans bearing measurable, weathered residues.  In may be necessary  to  use
        exaggerated rates to obtain such residues.  If residues are found to concentrate upon processing,
        then appropriate food/feed additive tolerances must be proposed.

    14/ If the  registrant seeks a crop group tolerance, additional data are required depicting diphenamid
        residues of concern in or on peppers treated within one month following direct seeding or transplanting
        with a  single broadcast application of a WP or FlC (4 Ib/gal) formulation at 5 Ib ai/A.  Tests must
        be conducted  in CA(18%), FL(23%) , and TX(16%) which represent the major U.S. sweet pepper growing
        regions (1982 Census of Agriculture, pp. 349-350).

    15/ Data must be  submitted depicting diphenamid residues of concern in or on catsup, juice, puree, and  dry poinace
k.       processed from tomatoes bearing measurable weathered residues.  Exaggerated application rates
        may be  necessary, to achieve such residue levels.  If residues are found to concentrate in any
        processed product, appropriate food/feed additive tolerances must be proposed.

        If the  registrant desires a crop group tolerance, use directions must be proposed, and appropriate  supporting
        residue data  submitted for the representative group member pears.

    _T7/ Data must be  submitted depicting diphenamid residues of concern in or on apples harvested 90 days following
        one directed  spray soil application of a WP formulation at 6 Ib ai/A.  Tests must be conducted in MI(9%),  7
        NY(12%),  WA(36%), and VA(6%) (state percent of total U.S. production given parenthetically data from
        Agricultural  Statistics. 1985, p. 196).

-------
§158.125 Residue Chemistry -  Continued

  187  Data must be submitted  depicting diphenamid residues of concern in apple juice  and  dry pomace processed from
  ~~  apples bearing measurable weathered residues (exaggerated application rates may be  necessary to achieve
      such residues).  If residues are found to concentrate in either commodity, then appropriate
      food/ feed additive tolerances must be proposed.
  19/  If the registrant seeks a crop group tolerance, use directions must be proposed, and  appropriate
  —  supporting residue data submitted for the additional representative group members cherries and plums.
  20/  If the registrant seeks a crop group tolerance, use directions must be proposed, and  appropriate
      supporting residue data submitted for additional representative group members (blueberries, cran-
      berries,  and grapes).
  217  Data depicting diphenamid residues of concern in or on raspberries harvested 60 days  following one directed
      spray soil application  of a WP formulation at 6 Ib ai/A must be submitted.  Field trials  must be conducted in
      MI(3%)  and WA(44%)  (state percentages of U.S. raspberry acreage appear parenthetically)
      (1982 Census of Agriculture. Vol. 1, Pt. 51, p. 372).
  22/  Data must be submitted  depicting diphenamid residues of concern in hulls, meal, crude oil, refined oil, and
      soapstock processed from cottonseed bearing measurable,  weathered residues.  It may be necessary to use
      exaggerated rates to obtain such residues.  If residues are found to concentrate upon processing then appro-
      priate food/feed  additive tolerances must be proposed.
  237  Data must be submitted  depicting diphenamid residues of concern in meal, crude  oil, refined oil, and soap-
      stock processed from peanuts bearing measurable, weathered residues (exaggerated rates may be necessary
      to achieve such residues).  If residues concentrate in these processed commodities, appropriate
      food/ feed additive tolerances must be proposed.
  247  Data must be submitted  depicting diphenamid residues of concern in or on green, freshly harvested tobacco
      receiving the following full-season treatment schedules in separate tests: one  broadcast  soil application 7
     days after transplanting of a WP formulation at 6 Ib ai/A followed by one soil  band application at layby after
     the last  cultivation of a WP formulation at 2 Ib ai/A; and (ii) the same applications except at 2 and 6 Ib
     ai/A, respectively.  Applications must be made by ground equipment.
  25/  If residues in freshly  harvested green tobacco exceed 0.1 ppm, data depicting residues in or on dried or cured
     tobacco will be required.  If residues in or on dried or cured tobacco exceed 0.1 ppm,  pyrolysis products
     derived fron the  active ingredient must be characterized and the level of residue in  smoke must be quantified.
      (Ring-labeled [ l^C] diphenamid must be used for identification of pyrolysis products.)
f\O
         and
 26 / The nature of  the residue in animals is not adequately understood and outstanding data gaps exist for many
     processed  feed items.  Upon receipt of the data requested in the sections "Nature of  the  Residue in Animals"
     and "Magnitude of the Residue in Animals", the established tolerances will be assessed, and the adequacy of  the
     available  data regarding the magnitude of residues will be determined with consideration  for any additional
     residues of Lexicological concern.

 27/ The Guidelines and use patterns indicate that these data are not required.

-------
                    TABLE A
GENERIC WTA KEQUIREMENTS TOR DIPHENAMID
Data Requiranent
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradat ion
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
163-1 - Leaching &
Adsorption/
Desorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
TGAI or PAIRA A,B

TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A,B
TEP A
TEP A
Yes 001 57344

No
No
No
No
No
No
No
*
No
No
No
Must Addtl Time Frame
Data be for
Submitted? Submission
No

Yes 9 Months
Yes 9 Months
Reserved 1 /
Yes July 1987 _2/
Yes July 1987 2J
No y
No V
Yes 12 Months
Yes 12 Months
Reserved 4/

-------
                                               TABLE A
                             GENERIC DATA REQUIREMENTS FOR DIPHENAMID
l>it:a Requiranent
Test
Substance
Use
Patterns
Does EPA Bibliographic
Have Data? Citation
Must Addtl Time Frame
Data be for
Submitted? Submission
§158.130 Environmental Fate - Continued
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
1 64-3 - Forestry
1 64-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
TEP
TEP
TEP
- -
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
TEP
A,B
A
A
A,B
A
A
A
N/A
A
N/A
No
No
No
No
No
No
No
No
No
No
^
Yes 27 Months
Noj>/ ~
No_3/
No 6/
Reserved 7/
Yes 39 Months
Reserved jj/
No_5/
Yes 12 Months
No _5 /
Organisms

-------
                  TABLE A
GENERIC DATA REQUIREMENTS FDR DIPHENAMID
l>> ta Requi r emen t
§158.140 Reentry Protection
132-1 - Foliar Dissipation
1 32-1 - Soil Dissipation
1 33-3 - Dermal Exposure
1 33-4 .- Inhalation Exposure
§158.142 Spray Drift
201-1 - Droplet Size Spectrum
201-1 - Drift Field Evaluation
Test
Substance
TEP
TEP
TEP
TEP
TEP
TEP
Use
Pattern
A,B
A
' A.B
A,B
A
A
Does EPA Bibliographic
. Have Data? Citation
No
No
No
No
No
No
Must Addtl Time Frame
Data be for
Submitted? Submission
Reserved 9/
Reserved 9/
Reserved 9/
Reserved 9/ LO
Reserved 9/
Reserved 9/

-------
                                                     TABLE A
                                    GENERIC DATA REQUIREMENTS FOR DIPHENAMID

§158.130 Environmental Fate - Continued

J_/ Photodegradatton test in air is reserved pending results of the laboratory volatility studies.

2J The registrant requested on 2/11/87 an extension of time from March 1987 to July 1987 to complete  the following
   soil metabolism tests: 162-1 and 162-2.  The Agency has granted the extension of time for these  soil  metabolism
   tests.

JJ/ The Agency has waived the data requirements for (a) anaerobic aquatic study [162-3] and (b) forestry  dissipation
   study [164-3] which were required in the Ground Water Data Call-in Notice of 6/26/84.  This decision  has  taken into
   consideration that the registrant has revised all forestry uses to ornamental uses for diphenanid  products.

_4/ Field volatility study is reserved pending results of the laboratory studies.

J>/ The Guidelines and use patterns indicate that these data are not required.

6/ The data requirements for combination and tank mixes are not being imposed in this Standard.

TJ Soil long terra study is reserved pending results of acceptable aerobic soil metabolism and field dissipation
   studies.

8/ Rotational crop field study is reserved pending results of an acceptable confined rotational  crop  study.

9/ Reentry and spray drift data may be required if the results of the toxicity tests being required under this
   Standard indicate that a significant chronic toxicity hazard may exist.
ON

-------
                                                        TABLK A
                                      CKNERIC DATA REQUIREMENTS FDR DIPHENAMID
D;ite
SI 58.
ACUTE
81-1
81-2
81-3
81-4
81-5
81-6
Requirement
135 Toxicology
TESTING:
- Acute Oral Toxicity
- Acute Dermal Toxicity
- Acute Inhalation
Toxicity
- Primary Eye Irritation
- Primary Dermal
- Dermal Sensitization
Tost
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns
A,
A,
A,
A,
A,
A,
1
Does EPA Bibliographic
Have Data? Citation
*
Yes 00114560
Yes 00114575
No
Yes 00077881
No
No
Must Addtl
Data be
Submitted
No
No
Yes
No
Yes
Yes
Time Frame
for
Submission
9 Months
1^.
-3-
9 Months
9 Months
81-7 - Acute Delayed
       NeurotoxLcity - Hen

SUBCHRONIC TESTING:

82-1 - 90-Day Feeding -
        Rodent
        Nonrodent (dog)

82-2 - 21-Day Dermal
TGAI
TGAI
TGAI
A,
A,
No
         No
                                                       No
                                                       No 1/
                                                       No A/
                                                                                         Yes
                                                                      12 Months

-------
                                                     TABLE A
                                   GENERIC  DATA RBQUIRKMENTS FOR DIPHENAM1D
Data Requirement
§158.135 Toxicology - Continued
SUBCHRONIC TESTING :
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation
82-5 - 90-Day Neurotoxi city-
Hen
CHRONIC TESTING:
83-1 - Chronic Toxicity -
Rodent (rat)
Nonrodent (dog)
83-2 - Oncogenicity -
Rat
Mouse
83-3 - Teratogenicity -
Kat
Rabbit
83-4 - Reproduction -
2 - PPPPrP f- i rtrt
Test
Subs tance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns
A,
A,
A.
A,
A,
A,
A,
A,
A,
A.
Does EPA Bibliographic
Have Data? Citation
•
No
No
No
No
Yes 00076382
No
No
No
No
Yes 00076383
Must Addtl
Data be
Submitted?
No 21
Reserved 5/
No \J
Yes
No
Yes
Yes
Yes
Yes
No
Time Frame
for
Submission



50 Months

50 Months
June 1988
15 Months
15 Months

OO

-------
                                                      TABLE A
                                      GENERIC Q\TA REQUIREMENTS FOR DIPHENAMID
Data Requirement
 Test        Use       Does EPA     Bibliographic
 Substance   Pattern   Have Data?   Citation
                                           Must Adcltl    Time Frame
                                           Data be        for
                                           Submitted?    Submission
§158.135 Toxicology - Continued

 MUTAGENICITY TESTING

 84-2 - Gene nutation
         (Ames Test)
 84-2 - Other Genotoxic
         Effects
TGAI
 84-2 - Structural Chromosomal    TGAI
         Aberration
TGAI
A,


A.


A,
No
                       No
No
Yes
                                  Yes
Yes
9 Months
               12 Months
12 Months
 SPECIAL TESTING

 85-1  -  General Metabolism
 85-2 - Domestic Animal
         Safety
PAI or
PAIRA

Choice
A,


A,
Partially    00077893, 00093606   Yes
                  »


No                                No 3/
                                                                                                         24 Months

-------
                                                     TAIil.K A
                                     t.'KNKRLC DATA KMQU IRAKI'S  TOR  DIPHENAMID
§158.135 Toxicology  - Continued
                                                                        i
 I/ Because diphenamid  is not structurally related to the known  family of  neurotoxins, organophosphates,  this
 ~  neurotoxicity study is not required.

 2/ This study  is not needed because the existing acceptable end-uses  should not result in  repeated  human skin
 ~~  contact for extended periods.

 3/ Use patterns in conjunction with the Guidelines indicate that  these data are not required.

 kj This study is not necessary since an adequate chronic feeding  dog  study is available.

 _5/ A subchronic inhalation study is required for use on tobacco if  residues occur in dried tobacco.
  en
  o

-------
                  TABLE A
GENERIC DATA REQUIREMENTS FOR DIPHENAMID
Data Requirement Test Use
Substance Pattern
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral LDjO TGAI A,B
71-2 - Avian Dietary 1^50
a. Waterfowl TGAI A,B
b. Upland game bird TGAI A.B
71-3 - Wild Mammal
Toxicity TGAI A,B
71-4 - Avian Reproduction
a. Waterfowl TGAI A,B
b. Upland game bird TGAI A,B
71-5 - Simulated Field Testing
- Mammals, and TEP A B
- Birds
Actual Field Testing
- Mammals , and TEP A B
- Birds
AQUATIC ORGANISM TESTING
72-1 - Acute Toxicity,
Freshwater Fish
• a. Warmwater TGAI A(B
b. Coldwater TGAI A,B
Does EPA Bibliographic
Have Data? Citation

No
No
No

No
No
No
No
No
No
No
•
Must Adcltl Time Frame
Data be for
Submitted? Submission

Yes 9 Months
Yes 9 Months
Yes 9 Months

No \J
No 21
No 21
No J/ 21
No \J 21
Yes 9 Months
Yes 9 Months

-------
                                                          TABLK A
                                       CKNKKIC LV\TA REglJIRFMKNTS FOR DlPHENATflD
Data Requirenent
§158.145 Wildlife and
Aquatic Organisms
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation

Must Adcltl
Data be
Submitted?

Time Frame
for
Submission

AQUATIC ORGANISM TESTING

72-2 - Acute LC5o Freshwater   TGAI
       Invertebrates

72-3 - Acute LC^Q Estuarine    TGAI
        and Harine Organisms

72-4 - Fish Early Life
       Stage and Aquatic
       Invertebrate Life-      TGAI
        Cycle
72-5 - Fish full Life-cyle

72-6 - Aquatic Organism
         Accumulation
72-7 - Simulated Field         TEP
        Testing
          - Aquatic Organisms

      - Actual Field Testing
          - Aquatic Organisms
A,B


A,B




A,B
A,B
Yes


No
00138963
No
TGAI
TGAI. PAI,
Degradation
Product
A,B
A.B


No
No


No
No


No 3/
                     No 3/


                     No J}/

                     No 3/



                     No 3/
 01
 ro

-------
                  TABLF. A
GKNERIG DATA REQUIREMENTS FOR DIPHENAMID
Data Requiranent
§158.
121-1
150 Plant Protection
- Target Area Phytotoxicity
Test Use Does F.PA Bibliographic Must Addtl Time Frame
Substance Pattern Have Data? Citation Data be for
Submitted? Submission
TGAI A.B No -
No . 4/
NONTARGET AREA PHYTOTOXICITY

122-1
122-1
122-2

123-1
123-1
123-2

124-1
124-2
TIER I
- Seed Germination/
Seedling Emergence
- Vegetative Vigor
- Aquatic Plant Growth
TIER 11
- Seed Germination/
Seedling Emergence
- Vegetative Vigor
- Aquatic Plant Growth
TIER III
- Terrestrial Field
- Aquatic Field

TGAI A.B No
TGAI A.B No
TGAI A,B No

TGAI A.B No
TGAI A,B No
TGAI A.B No

TGAI A.B No '
TGAI A.B No

No 4/
No 4/
Yes J>/ 9 Months

No 4/
No 4Y
No 4/

No 4/
No 4/

-------
                                             TAHI.K    A
                                     (JKNKKIC DATA RRQUIRHMKNTS R)H DIPHIilNAMID

 §158.145 Wildlife and Aquatic Organisms - Continued

  J_/ Surrogate data  indicate that diphenamid is Low in toxicity to mammals, therefore the study is not  required.

  27 Data on a formulated product indicate that diphenamid is very low in toxicity to waterfowl and upland  gamebirds,
     therefore, the studies are not required.

  3/ Data on formulated products and surrogate data indicate that these studies  are not required.

  4/ Phytotoxicity testing can be required on a case-by-case basis to support, among others, end-use products  that may
     pose hazard to endangered or threatened plant species.

  5/ Required for large acreage herbicide use with the potential for runoff into aquatic systans.
c_n

-------
   Data Requirenent
                                                          TABLK A
                                CKNKRIC Ii\TA  RhQIJIRWIKNTS K>R DIIUENAMID
Test
Substance
Use
Pattern
Does EPA
Have Data?
Biblipgraphic
Citation
Must Addtl
Data be
Submitted?
Time Frame
 for
Submission
  §158.155 Nontarget Insect

  NONTARGET INSECT TESTING -
  POLLINATORS:

  141-1 - Honey bee acute
           contact toxicity

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

  141-4 - Honey bee subacute
           feeding study

  141-5 - Field testing for
           pollinators

1 NONTARGET INSECT TESTING -
« AQUATIC INSECTS:

l 142-1 - Acute toxicity to
           aquatic insects

  142-1 - Aquatic insect
           life-cycle study

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

  NONTARGET INSECT TESTING

  143-1 - Predators and
   thru
  143-3 - Parasites
TGAI         A

TEP          A



(Reserved) 21


TEP          A
(Reserved) _3/


(Reserved) 3/


(Reserved) 3/
(Reserved) 3/
          Yes

          No
             00018842
                     No

                     No 1/
          No
                                  No I/

-------
                                                      TABLE A
                                    GKNKRIC DATA RBQUIREMENTS FDR DIPHF.NAMID


\J Data tram the acute contact study show low toxicity'to honey bees.  Therefore,  no further testing is required,

2J Data requirements are reserved pending development of test methodology.

y Data requirements are reserved pending an Agency decision as to whether the data  requirement should be
   established.
O\

-------
                                                        TABLK H-l
    PRODUCT  SPKC1FLC IttTA KII}UIKKMKNTS WR IHPIIFNAMID 95% Fla (KPA RF,G.NO. 45639-120)
    PRODUCT  SPKC1F1C DATA RI/
Yes 6/
Yes 11
Time Frame
for
Submission
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
Other Requirements:

64-1  - Submittal of Samples
                                          N/A
No
                                                                               N/A
                                                                                                   No  8/
CJl

-------
                                                    TAHJJ-: B-1
 PRODUCT SPECIFIC DATA KBJIIL KIM-MS TOR DIPHENAMID 95% FIa & 90% FIb (EPA REG.NOS. 45639-108  and 120)

 §158.120 Product Chemistry (Continued)

 a The 95% formulation intermediate  (FI) serves as a manufacturing-use product.
 b The 90% formulation intermediate  (FI) serves as a manufacturing-use product.

 I/ Not applicable.  Although  product chemistry data may have been submitted in  the  past,  the Agency has determined  that
 ~ certain data must be resubmitted  for each pesticide.  New requirements have been  introduced and previously
   submitted data must be updated.  The bibliographic citations for old data are not applicable.
 2f The chemical name and CAS  Registry no. of each intentionally added inert must be  submitted, along with the
 ~ identity (e.g., EPA Reg. No.).
 3/ Complete information must  be provided regarding the nature of the process (batch  or  continuous), the relative amounts
 ~ of beginning materials and the order in which they are added, a flow chart with chemical  equations for each intended
   reaction, equipment used to produce the product, reaction conditions, the duration of  each step of the process,
   purification procedures, and quality control measures.  In addition, the name and address of the manufacturer,
   producer or supplier of each beginning material must be provided along with information regarding the properties of
   each beginning material used.
 4_/ A detailed discussion of all impurities that are or may be present at X).1%, based on  knowledge of the beginning
   materials, chemical reactions (intended and side)  in the manufacturing process, and  any contamination during and
   after production must be submitted.
_5/ Five or more representative samples must be analyzed for the amount of active ingredient  and toxicologi-
   cally significant inerts.  Complete validation data (accuracy, precision) must be submitted for each
   analytical method used. In addition, all nitrosamines must be identified and quantified in six samples;
   two samples each must be analyzed shortly after production, 3 months after production, and 6 months
   after production.
y Upper and lower limits for diphenamid must be provided, certified, and validated  by  sample analysis using analytical
   procedures for which accuracy and precision data have been provided.   Upper and lower  limits for each intentionally
   added inert must be provided, certified, and validated by sample analysis using analytical procedures for which
   accuracy and precision data have been provided.  Upper limits for each impurity present at X).1% (w/w) , and for  each
   "toxicologically significant" impurity present at <0.1% (w/w) must be provided, certified, and validated by sample
   analysis using analytical  procedures for which accuracy and precision data have been provided.
   Certifications must be submitted on EPA Form 8570-4, Rev. 2-85.
]_l Analytical methods  must be provided to determine the active ingredient and each toxicologically significant impurity
   and intentionally added inert for which a certified limit is required.  Each method  must  be accompanied by validation
   studies indicating  its accuracy and precision.  These methods must be suitable for enforcement of certified limits.

S/ The compound does not require submission of samples at this time.
 Ul
 OO

-------
                                                     TABLE B
              PROUULT SPKCIKIC DATA REQUIREMENTS TOR MANUFACTURING-USE PRODUCTS CONTAINING DIFHENAMID
Data
§158.
ACUTE
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Requirement
135 Toxicology
TESTING:
- Acute Oral Toxicity
- Acute Dermal Toxicity
- Acute Inhalation
Toxicity
- Primary Eye Irritation
- Primary Dermal
- Dermal Sens itizat ion
- Acute Delayed
Neurotoxicity - Hen
Test
Substance


TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Pattern


A,
A.
A.
A,
A.
A,
A,
Does EPA Bibliographic
Have Data? Citation


Yes . 00114560
Yes 00114575
No
Yes 00077881
No
No
No
Must Addtl
Data be
Submitted?


No
No
Yes
No
Yes
Yes
No \J
Time Frame
for
Submission




9 Months

9 Months
9 Months

I/ Diphenamid is not  an brganophosphate and available data do not  indicate  a neurotoxicological problem.
  LH

-------
                          SUMMARY-1

                        LABEL CONTENTS

     40 -CFR 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 CFR 162.10(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 162.10(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 CFR 162.10(f)]

    Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel.  The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel.  It must not be
placed in the body of other text.  [40 CFR 162.10(g)]

                             60

-------
                            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)(ii)]

    Item 7B.  SIGNAL WORD - The signal word '(DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement.  [40 CFR 162.10 (h)(l)(i)]

    Item 7C. ~ SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON.   [40 CFR 162.10(h)(1)(i)]

    Item 7D.  STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III.  [40 CFR 162.10(h)(1)(iii)]

    Item 7E.  REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products,  unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iii)]

    Item 8.  SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline.  Each
of the three hazard warning statements must be headed by the
appropriate hazard title.  [40 CFR 162.10(h)(2)].


                                   61

-------
                          SUMMARY-3

    Item 8A.  HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage.  [40 CFR 162.10(h)(2)(i)]

    Item 8B.  ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage.  [40 CFR 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 mxist
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 162.11(c).  You will be notified of
the Agency's classification decision.
                                 62

-------
                          SUMMARY -4

     Classification Labeling Requirements

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

     1.  All uses restricted.

         a.  The statement "Restricted Use Pesticide" must
     appear at the top of the front panel of the label.  The
     statement must be set in type of the same minimum size
     as required for human hazard signal word (see table in 40
     CFR 1b2.1
         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
     reregistration, each containing all forms and necessary
     labels.  Both applications should be submitted simul-
     taneously.  Note that the products will be assigned
     separate registration numbers.

    Item 9B.  MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
                                    63

-------
                          SUMMARY-5

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

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

    Item IOC.   DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide.  When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 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.
                                       64

-------
                                                       SUMMARY-6

                                     LABELING REQUIKQ1ENTS OF THE FIFRA,  AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product nane
Company nane
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
pr ecaut ionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
r ' PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement

Above signal
word
*•
. Immediately
below child
hazard
' warning
COMMENTS

If registrant is not the producer, must
be qualified by "Packed for . .
"Distributed by. . . ," etc.
May be in metric units in addition to
U.S. units
Mast 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 statement:;
must be grouped together, preferably
blocked .
Note type size requirements.
Note type size requirements.
ON
U1

-------
                                                       SUMMARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull ft cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/ back panel
precatitionary
statements
Hazards to
humans and
domestic
animals
Envi ronmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
vhich are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity^
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
pr ec aut ionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
• signal word
Front panel
for all.

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


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

-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
s tatement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
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
Iramed lately
before
' specific
directions
for use or
at the end of
directions
• for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statanent of the terms of
restriction. The words "RESTRICTED USl-l
PESTICIDE" must be same type size as
signal word.
Required statanent is:
"It is a violation of Federal law
to use this product in a mariner
inconsistent with its labeling."

Mast 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 statenents.
May be in metric as well as U.S. units

-------
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.
   (ii)  All 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
                                   68

-------
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
product for 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;
                                  69

-------
  (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
onto 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
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
  (4)   In all cases, net content shall be stated in terms of the
largest suitable units, i.e., "1 pound 10 ounces" rather than
"26 ounces."
                                    70

-------
  (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 of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients" and the inert ingredients by the term "inert
ingredients," or the singular forms of these terms when appropriate.
Both terms shall be in the same type size, be aligned to the same
margin and be equally prominent.  The statement "Inert Ingredients,
none" is not required for pesticides which contain 100 percent
active ingredients.  Unless the 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.


                                    71

-------
  (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
practice.  If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
  (6)  Deterioration.  Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements :
  (i)  In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent po'sition o'n 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 chemical 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:
                                    72

-------
Hazard Indicators

Oral LD5o
Inhalation 1C
Dermal LD
50
Eye effects
Skin effects


1
Up to and
Including
50 mg/kg
Up to and
Including
.2 mg/l Iter
Up to and
tnclud Ing
200 mg/kg
Corrosive;
cornea) opacity
not reversible
within 7 days
Corrosive

Toxlclty <
II
From 50 thru
500 mg/kg
From .2 thru
2 mg/l Iter
From 200
thru 2000
Corneal opacity
reversible
within 7 days;
Irritation
persisting for
7 days
Severe Irritation
at 72 hours

:ategor les
1 1 1
From 500 thru
5000 mg/kg
From 2 thru
20 mg/l Iter
From 2,000 thru
20,000
No cornea 1 opacity;
Irritation
reversible
within 7 days
Moderate Irritation
at 72 hours


IV
Greater than
5000 mg/kg
Greater than
20 mg/l Iter
Greater than
20,000
No Irritation
Mild or slight
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 to Toxicity Category I
the basis of its oral, inhalation or dermal toxicity (as di
    or
   the
                       on
                     istinct
word "Poison" shall appear
contrasting color and the
the basis of its oral,
from skin and eye local effects) unc WWLU  r-vjjL=>i_m  auaxj. appeal
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "poison."
       Toxicity Category II.  All pesticide products meeting the
       a of Toxicitv Cateaorv II shall bear on the front panel*'
  (B)  	     _
criteria of Toxicity Category
the signal word "Warning."
  (C)  Toxicity Category III.
criteria of Toxicity Category
the signal word "Caution."
  (D)  Toxicity^Category IV.
criteria of Toxicity Category
the signal word "Caution."
 All pesticide
III shall bear

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

       products meeting the
       on the front panel
                                 73

-------
  (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 5 to 10 	
Above 10 to 15 	
Above 15 to 30 	
Over 30 	
Points
Required
signal word,
all capitals
6
10
12
14
18
"Keep out
of reach of
Children"
6
6
8
10
12
                                      74

-------
   (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.
Toxlcl.ty
category
                          Precautionary statements by toxictty category
  Oral,  Inhalation, or dermal  toxicIty
      Skin and eye local effects
 II .
Ill .
 IV . . .
Fatal (poisonous) If swallowed  [Inhaled or
 absorbed through skin). Do not breathe
 vapor [dust] or spray mist].  Do not get
 In eyes, on skin, or on clothing IFront
 panel statement of practical treatment
 required.].'

May be fatal If swallowed I Inhaled or
 absorbed through the skin). Do not breathe
 vapors Idust or spray mist].  Do not get In
 eyes, on skin, or on clothing. tApproprlate
 first aid statements required.!.

Harmful If swallowed I Inhaled or absorbed
 through the skin).  Avoid breathing vapors
 Idust or spray mist).  Avoid contact with
 skin I eyes or clothing]. (Appropriate
 first aid statement required.].

I No precautionary 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.
lApproprlate first aid statement required.)

Causes eye land skin] Irritation. Do not
 get In ayes, on skin, or on clothing.
 Harmful If swallowed.  (Appropriate first
 aid statement required.].
Avoid contact with skin, eyes or clothing.
 In case of contact Immediately flush
 eyes or skin with plenty of water.  Get
 medical attention If Irritation persists.
(No precautionary statements required.].
                                                                          «
    (ii)   Environmental  hazards.   Where a hazard exists  to non-
 target  organisms  excluding  humans  and domestic animals, precautionary
 statements  are  required  stating the  nature  of the hazard and  the
 appropriate precautions  to  avoid potential  accident,  injury  or
                                          75

-------
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
Required text
(A) PRESSURIZED CONTAINERS
Flash point at or below 20*F; If there Is a
flashback at any valve opening.
Flesh point above 20*F and not over 80*F or If
the flame extension Is more than 18 In. long
at a distance of 6 In. from the flame.

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 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 puncturfe or
Incinerate container. Exposure to tempera-
tures above 130*F may cause bursting.
(B) NONPRESSURIZED 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.
                              76

-------
  (i)  Directions for Use—(1)  General requirements—(i)  Adequacy
and clarity of directions.  Directions for use must be  stated  in
terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect  the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment.
  (ii)  Placement of directions for use.  Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide  product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
  (A)  If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide,  or placed
within the outside wrapper or bag;
  (B)  The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular."  and
  (C)  The Administrator determines that it is not necessary for
such directions to appear on the label.
  (i i i)  Exceptions to requirement for direction for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
  (_!)  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
  (4_)  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 physicians,
veterinarians, or druggists, provided that:
  (JJ  The label clearly states that the product is for use only
by physicians or veterinarians;
  (2)  The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
  (3)  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:
  (\)  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 ;


                                       77

-------
  (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.
                                     78

-------
  (F)  Other pertinent information which the Administrator
determines to be necessary for the protection of man and  the
environment.
  (j)  Statement of Use Classification.  By October 22, 1976, all
pesticide products must bear on their labels a statement  of use
classification as described in paragraphs  (j)(l) and (2)  of this
section.  Any pesticide product for which  some uses are classified
for general use and others for restricted  use shall be separately
labeled according to the labeling standards set forth  in  this-
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both  restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use.  Such products shall be subject to the
provisions of § 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]
                                     79

-------
                           PHYS/CHEM-1

                    PHYSICAL/CHEMICAL HAZARDS
Criteria
I.   Pressurized Containers

    A.  Flashpoint at or below
        20°F;  or if there is a
        flashback at any valve
        opening.
    B.  Flashpoint above 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.
    B.  Flashpoint above 20°F
        and not over 80°F.

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

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

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

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

Flammable.  Keep away from
heat and open flame.

Do not use or store near
heat and open flame.

None required.
                                     80

-------
                            STOR-1

             STORAGE INSTRUCTIONS FOR PESTICIDES

Heading:

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

Storage Instructions:

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

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

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

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

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

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

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



                                     81

-------
                          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)
  J_/ Manufacturer may replace this phrase with one indicating
     whether and how fiber drum may be reused.

                                          82

-------
                          PEST/DIS-1

               PESTICIDE DISPOSAL INSTRUCTIONS

The label of all products,  except those intended solely for
domestic use, must bear explicit instructions about  pesticide
disposal.  The statements listed 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. viola-
    tion 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 Environ-
    mental 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 state-
ment :

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

5.  Products intended for domestic use only must bear the follow-
ing disposal statement:

    "Securely wrap original container in several layers of
    newspaper and discard in trash."


                                        83

-------
             tip ft Compendium of Acceptable  Uses

                        DIPHENflMID

                     TABLE OF CONTENTS

Site Name	Page

TERRESTRIftL FOOD CROP                                         3
  (Agricultural Crops)                                        3
TERRESTRIAL NONFOOD CROP                                      9
  (Agricultural Crops)                                        9
  (Ornamental Plants and Forest Trees)                       10

  African Daisy                                              10
  fileppo Pine                                                11
  Algerian Ivy (ground cover)                                14
  ftlyssurn                                                    10
  ftpple                                                       3
  ftpple  (ornamental)                                         11
  ftrborvitae                                                 1 1
  fish                                                        11
  ftster                                                      10
  Azalea                                                     11
  Baby's Breath                                              10
  Baby's Tears (ground cover)                                14
  Bald Cypress                                               11
  Barberry                                                   11
  Beauty Bush                                                11
  Beech                                                      11
  Begonia              "                 •       ,    •          10
  Bermudagrass                                               14
  Big Blue Lily Turf                                         14
  Birch                                                      11
  Black Locust                                               11
  Black Raspberry                                             4
  Black Walnut                                               11
  Blackberry (non-bearing)                                    3
  Blackgurn                                                   11
  Blueberry (non-bearing)                                     3
  Bottlebush                                                 11
  Boxwood                                                    11
  Bugleweed (ground cover)                                   14
  Butterfly Orchid                                           10
  California Fan Palm                                        11
  California Poppy                                           10
  California Privet                                          11
  Cajeput Tree                                               11
  Camellia                                                   11
  Carob                                       •               11
  Carolina Cherry Laurel                                     11
  Ceanothus                                                  11
  Ceanothus (ground cover)                                   14
  Cherry (non-bearing)                                        3
  Cherry Laurel                                              11
  Chestnut                                                   11
  Chinese Chestnut                                           11
  Chrysanthemum                                              10

Issued:  4-01-66        I-03£601-i
Provisional Update:  4-29-87
                                                 84

-------
                        DIPHENOMID

                     TftBLE OF CONTENTS

Site Name	Pane
Cinquefoil (ground cover)
Cosmos
Cotoneaster
Cotton
Cott onwood
Crabapple (ornamental)
Crearn Carpet
Crown-of -Thorns
Cupaniopsis anacard i ops is
Cypress
Dan 1 ias
Dent si a
Dichondra
Dogwood
Dwarf Coyotebrush (ground cover)
Elaeagnus
English Ivy (ground cover)
Eucalyptus
Euonyrnus
Fern Podocarpus
Fetter-Bush
Feverfew
Ficus
Fir
Fi ret horn
Flowering fllmond
Flowering Currant
Forsyth ia
Gazania (ground cover)
Gerani urn
Har lands Boxwood
Hawaiian Tree Fern
Heath
Heavenly Bamboo
Hel iotrope
Hemlock
Holly
Honey locust
Honeysuckle
Hydrangea
Ice Plant (ground cover)
India Hawthorn
Indian Laurel
Jacaranda acuti folia
Japanese Black Pine
Japanese Holly
Japanese Snowball
Japanese Yew
Juni per
Juniper (ground cover)
14
10
1 1
4
11
': 1
11
1 1
11
15
10
1 1
16
11
14
1 1
14
11
1£
i£
1£
10
IS
15
It-
IE1
1£
1£
14
10
1£
1£
1£
1£
10
IS, 15
IS
1£
IS
IS
14
IS
10
IS
IS
IS
IS
IS
IS
14
Issued:  4-01-86        I-036601-ii
Provisional Update:  4-S9-S7

-------
                 compendium of Acceptable Uses

                        DIPHENfiMID

                     7 A B LE OF CDN7EN7S
Site Name
                                      Pane
Larch
Larkspur
Laurel
Li gust r urn
Lilac
Li ly-of-the-Ni le
Lirne (non-bear ing )
Lobel ia
London Plane
Loosest ri fe
Mahonia
Maple
Mar i gold
Mirror Plant
Mock Orange
Monterey Pine
Moreton Bay Fig
Mount a i n-Laure 1
Mugho Pine
Mult if lor a Rose
Norway Maple
Oak
Okra
Oleander
0 1 i ve ( ornament a 1 )
Orange (non-bearing")
Oriental flrborvitae
Ornamental Evergreen Pear
Peach
Peach ( ornament a 1 )
Peanuts
Pear (ornamental)
Pecan (ornamental)
Peonies
Peppers
Periwinkle (ground cover)
Petunias
Ph i lodendron
Phlox
Pin Oak
Pine
Pineapple Buava
Pink Indian Hawthorn
Pittosporurn
P 1 urn ( ornament a 1 )
Potato
Raspberry (non-bearing)
Red Maple
Red Oak
Red Raspberry
15
10
i£
1£
i£
10
3
10
1£
10
1£
1£
10
1£
1£
1£
IS
IE-
IE
1£
1£
1£
4
' 1£
IS
3
1£
1£
3
1£
4
1£
1£
10
5
14
1O
10
10
IS
13,
13
13
13
13
c-
wJ
3
13
13
4
Issued:   4-01-86
Provisional Update:
   I-O36601-i i i
4-£9-S7
86

-------
                 Compendium of ftcceotabie Uses

                        DIPHENfiMID

                     TflBLE OF CONTENTS

Site Name	[	Pane

  Redbud                                                     13
  Redcedar                                                   13
  Rhododendron                                               13
  Rose                                                       13
  Sakaki                                                     13
  Salvia                                                     10
  Sandankwa Viburnum                                         13
  Sasanqua Camellia                                          13
  Scarlet Oak                                                13
  Scotch Heather                                             13
  Shasta Daisy                                               10
  Shore Juniper                                              13
  Shrub-ftlthea                                               13
  Silver Maple                                               13
  Snapdragon                                                 10
  Soybeans                                                    6
  Spineless Yucca                                            13
  Spirea                                                     13
  Spruce                                                     15
  St.  Johnswort                                              13
  Star Jasmine                                               13
  Stocks                                                     1O
  Stonecrop (ground cover)                                   14
  Strawberry                                                  6
  Strawberry (ornamental) (ground cover)                  .   14
  Sugar Maple                                                13
  Sweet Potato                                                6
  Sweet William                                              10
  Sweet g urn                                                   13
  Sycamore                                                   13
  Tobacco                                                     9
  Tobira                                                     13
  Tomato        •                                              7
  Tuliptree                                                  13
  Verbena                                                    1O
  Viburnum                                                   13
  Victoria—Box                                               13
  Weigela                                                    13
  Wei gela (bristol ruby)                                     13
  White fish                                                  13
  White Birch                                                13
  White Cedar                                                13
  Willow                                                     13
  Yellow Foxglove                                            10
  Yew                                                        13
  Yew Podocarpus                                             13
  Z i nn i a                                                     10
Issued:  4-01-86        1-036601-iv
Provisional Update:  4-29-87                        87

-------
                  Uornpend i urn  of  Acceptable Uses

                        DIPHENfiMID*

TYPE PESTICIDE:   Herbicide
FORMULATIONS:
Tech (97-/.)
FI (90-/., 95%)
G ( 1. 4£'/i, £. 3"/-, £.
WP (5054, SO'/., 9054)
EC (18.3%)
F1C (1.39 Ib/gal or
GENERfii_ WARNINGS AND
65*, 3. 44*,
15. 4* a. i . ,
LIMITATIONS
                                  5. 554,
                                  A  Ib/gal  or 4£. 5'/. a. i.)

                                 i   ft selective preemergence herbi-
cide used to control  broad leaf  weeds and grasses in agricultural
and noncrop areas.  Pi  light  rainfall or irrigation following appli-
cation will improve weed  control.   Incorporation may be necessary
under dry soil conditions.   Do  not  apply directly to water or wet-
lands (swarnps, bogs,  marshes, and  potholes).  Do not apply to lakes,
ponds,  or streams.  Cover,  incorporate or  collect granules spilled
on the soil surface.   Do  not  contaminate water sources by cleaning
of equipment or disposal  of  wastes.   Crops other than those regis-
tered for this product should not  be planted in treated soil for 6
months after the  last  treatment.   Do not use product in direct com-
bination with fertilisers,  insecticides,  fungicides, or with other
herbicides except as  specifically  recommended.
Livestock Tolerances:
Cattle, fat
Cattle, meat
Cattle, rnbyp
Goats, fat
Goats, meat
Goats, rnbyp
Hogs, fat
Hogs, meat
Hogs, rnbyp
Horses, fat
Horses, meat
Horses, rnbyp
Milk
Sheep, fat
Sheep, meat
Sheep, rnbyp
0. 05
0. 05
. 0. 05
0. 05
0.05
0.05
0. 05
0. 05
0.05
0. 05
0. 05
0. 05
0.01
0.05
0.05
0. 05
(N>
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
pprn
pprn
p.pm
ppm
ppm
pprn
ppm
ppm
ppm
ppm
ppm
pprn
ppm
pprn
ppm
ppm
TIME REQUIRED FDR CONTROL;  Not  located.

PHYTQTOXICITY TO TARGET WEEDS;   Not  located.

PHYTDTOXICITY TO CROPS;  Not  located.

MODE OF ACTION;  Inhibits seed germination or early seedling growth
and root elongation by affecting the uptake of inorganic ions and
influencing the distribution  of  calcium.



*N, N-dirnethyl-£, £-d iphenylacet amide

Issued:  4-01-86        1-036601-1
Provisional Update:  4-E9-87

-------
                           Uornperid i urn  of  flcceotabie Uses

                                   DIPHENPMID
PftZfiOBB
PBF.CiEBPi
PPZPi^Bft
          BROADLEfiF WEEDS CONTROLLED!

PBFBOBB     Brassbuttons
PfiDftBBfi     Car pet weed
            Chickweed
            Common chickweed
            Common ragweed
            Corn spurry
            Cudweed
            Even ing or irnrose
            Field pep per weed
PBZftBftfi     Filaree
PEMQEBB     Florida pus ley
PBFCXftP     Groundsel
PftZSKBfl     Knawel
PEOOGAC     Knot weed
            Larnbsquarters
            Mallow
PPlZfiDBC     Mouseear chickweed
PDPRBftft     Oxalis
PfiZftlftft     Pearl wort
PfififtflBI     Pigweed
PPftftfiBP     Purslane
PEflftHBB     Red sorrel
PftFftCBI     Redroot pigweed
PBKftHBft    . Shepherdspurse
PEfiftBRD     Smart weed
PRFfiQBJ     Spiny amaranth
PBVfiGBK     Spotted spurge
PZflftftGJ     Spurweed
PftZftCBft     Thyme leaf sandwort
PCDBYBJ     White clover
          GRflSSES flND OTHER MONQCOTS  CONTROLLED!

PCftCKBfl     finnual bluegrass
PCfififtftB     flnnual grasses
PBMPDBO     ftnnual sedge
PCftBHBB     Barnyardgrass
PCfiftDflA     Bent grass
PCOftZBA     Berrnudagrass
PCfiCKfift     Biuegrass
PCOftTBK     Cheat
PCRBMflC     Coarse fescue
SCQBRBQ     Common velvet grass
PCfiBFftfi     Crabgrass
PCfiBCBfi     Crowfoot grass
PCftCEBD     Fall panic urn
PCftCUftfl     Foxtail
PCftBSBC     Foxtail barley
PCftCUBft     Giant foxtail
PCABIBfi     Goosegrass
PCflCWBC     Johnsongrass (from seed)
          Issued:  4-O1-86
                                   I-03660i-£
89

-------
                       iiPfl Compendium of Hcceptabie uses

                                  'DIPHENRMID

          GRftSSES fljxiDOTHER  MQNOCQTS  CONTROLLED (cont i nu e c)

PCfiCFBD     Knotgrass
PCfiBFE
-------
/OiOiSAfi
/£300500
/I501500
/£300700
                        EPfi Cornpenc i urn of ficceDtabie  Uses

                                   DIPHENftttlD

          Site, Dosage  ana   ••      Tolerance, use, Limitations
          Forrnulat ion
           (ib a. i. /ft)

            SIackberry  (non-bearing)  cluster  (continued)
              4-6
               (SO'/-,  90%  WP)
Black Raspberry
Red Raspberry
              £-6
               (50V.,  90'/.  WP)
               (4  Ib/gal  F1C)
Cotton
  3-4
  (SO'/-, 90'/. WP)
  (4 Ib/gal F1C)

Okra

  3-5
  (SO-/., 90'/. WP)
  (4 Ib/gal FiC)
Peach

Peanuts
              4-6
               (5O-/C,  90'/.  WP)
               (4 Ib/gal  FIC)

              £-3
               (SO-/.,  90'/.  WP)
               (4 Ib/gal  FIC)
Broadcast.  ftppiy  in  the fail or spring
before weeds emerge.   ftpply in 10 gallons
of water.

i. 0 pprn
60 day preharvest  interval.
1£ month  preharvest  interval for red rasp-
berry.
Do not use more  tnan  6 pounds active in-
gredient  during  a  growing season.

Directed  spray to  the soil.   ftpply after
planting  but before weeds germinate.
Apply prior to weed emergence in estab-
lished plantings or  immediately following
a cult ivat ion.

0. £     pprn  (cotton,  forage)
0.1 
-------
          Site, Dosage  and
          Form ill at i on
          (ib a. i. /ft)
               Compendium  of  flcceotabie Uses

                      DIPHENftMID

                        Tolerance,  Use,  Limitations
            Peanuts  (continued)
//110030ft
/14013flft
               (50-/.. 90%  WP)
               (4  Ib/gai  FiC)
Peppers
               (50'/., SO'/.,  SO'/.  WP)
               (4  Ib/oal  FIC)
  ESLN:
  5
  (50'/., 90S WP)

Potato
              4-6
              <50'/., 90'/. WP)
              (4 Ib/gal FIC)
               CSLN3
              &
               (SOS, 90'/. WP)

            Red Raspberry
Layby application  following  last culti-
vation.   Will not  control  established
weeds.  Do not  use if  more than £ pounds
active ingredient  per  acre were appiiec at
planting or cracking stages.

0.1  (N)  ppm  (fruiting  vegetables)
Do not graze treated areas.
General  Information;   Before treatment,
work all weed growth into  soil.

Direct seeding  treatment.   apply in £0 to
50 gallons of water per  acre.
             OR
Broadcast application  to transplants or
within 1 month  after transplanting.

SLN - Use limited  to Cft.
Preplant application.  ftpply by air once
per season.

1.0 ppm
5O day preharvest  interval.
General  Information!   finy  tillage opera-
tion such as dragging-off,  hilling,  etc.,
that brings untreated  soil to the surface
will result in  poor weed control.   Howev-
er, shallow cultivation  (0.5 to £ inches)
after application  will not reduce effec—
t iveness.

Preernergence.   Broadcast.   ftppiy in at
least 30 gallons of water  per acre.
             OR
Layby application.   Directed spray to base
of plants.

SLN - Use limited  to Cft.
Preplant application."  ftpply by air once
per season.

See Black Raspberry cluster.
          Issued:  4-O1-8&
                       1-036601-5
                              92

-------
/£SO£3flFi
Site.  Dos5.ce ano
Forriiul at :. or;
( i b a. i . / ft)

  Soybeans
                       EPft  'jornpenc i urn of Acceptaoie uses

                                   DIPHENfiMID

                                    Tolerance,  Use,  Lim i tat i on s
               (50%, so/.  WP>
               (4  ib/gal  F1C)
               (4  Ib/oai  FiC)
0. Zi     ppm  (soybean,  forage,  hay)
0. 1 (N) pprn  (soybean)
Do not plant food crops  other than soy-
beans within 6 months  after treatment.

At olantinq.  Broaacast.
                          Pit  olanting.   Broadcast or band.
                          Tank  mix  with linuron or ch lororooharn.
/Oi016Dft
  Strawberrv
/140180ft
              4-6
              ' (50%, 90% WP)
              (4 Ib/gal FIC)
              4-6
              (50'/.,- 90%  WP)
              (4 Ib/gal  FIC)
  Sweet Potato
              4-6
              (50%, 90% WP)
              (4 Ib/gal FIC)
              £-6
              (50%. 90%  WP)
              (4 Ib/gal  FIC)
i. 0 pprn
60 day preharvest  interval.
General I nf orrnat ion:   Do  not  use on the
herbicide sensitive  variety  Shasta.   A
temporary delay  in rooting of Daughter
plants may occur  but  will not affect
yield.

Posttransplant application.   Apply £ to 6
weeks after planting  but  before new fo-
liage has appeared.   Use  tne lower dosage
on light mineral  soils and the higher dos-
age on medium/fine mineral soils.   Apply
in 30 to 50 gallons  of water.

Dormant application  to established oiant-
ings.   May be applied to  serni-dormant
plantings or after bed renovation.   Addi-
tional applications  may be made at inter-
vals of 6 months  or  more.

0.1 (N) pprn

Post plant application to  soil after covei—
ing sweet potatoes.   Broadcast or band.
May be tank mixed with chloramben or orysa-
lin for preemergent  weed  treatment.
                          Post trans plant.   Broadcast or oand.
                          be  tank mixed with chloramben or oryzalin
                          for preemergent  weed treatment.
          Issued:  4-01-86
                         1-036601-6
                              93

-------
                       tPft Compendium of Receptacle Uses

                                  DIPHENHM1D
/11005 A A
          Site,  Dosage and
          Formu1 at i on
          (Ib a. i. /A)
Tomato
              4-6
              (50%,  SO'/., SO'/.
              (4 Ib/gal F1C)

              £-4
              (50-/.,  BO'/-, 90'/.
              (4 Ib/gal F1C)
              4-6
              (50%, 90%
              (4 Ib/gal
            WP)
            F1C)
              4-6
              (SO'/. WP)
              (4 Ib/gal
            F1C)
                        tolerance.  Use,  Limitations
      0.1  (N) pprn  (vegetable,  fruiting)
      General Information;   Following  initial
      watering,  beds should  be keot  at  the op-
      timum moisture level for seed  germination
      and emergence.  Allowing the  seedbed to
      dry out reduces the  level  of  herbicide
      effectiveness as well  as the  stand  ana
      vigor of the tomato  plants.   Do  not  use  on
      soils with over 10 percent  organic  matter
      or on soils with a salt  problem.

      Broadcast or band treatment.   Apply  1 week
WP)   before to 1 month after  direct seeding or
      transplant ing.

      Broadcast or band treatment.   Apply  1 week
WP)   before to 1 month after  direct seeding or
      transplanting.  May  be tank mixed with tri-
      fluralin,  pebulate,  or naproparnide.   Do
      not tank mix with trifluralin  or pebulate
      for use on direct seeded tomatoes except
      in CA.

      Use limited to CA.   Prep1ant  application
      to fields to be planted  in  with  direct
      seeded tomatoes.  Broadcast.   Apply  to pre-
      pared beds and incorporate  into  the  soil
      (1 to £ inches) with a power  driven  til-
      ler.   Do not apply earlier  than  14  days
      before seeding.  Immediately  following in-
      corporation and seeding,  the  beds should
      be thoroughly wet by furrow irrigation.
                   OR

      Use limited to CA.   Preplant  application
      to fields to be planted  with  direct  seeded
      tomatoes.   Broadcast with  disk incorpora-
      tion.  Apply in at least 30 gallons  of wa-
      ter per acre.  Following application the
      field should be double-disked  with  the sec-
      ond disk at right angles to the  first to
      uniformly incorporate  into  the soil  to a
      depth of 3 to 4 inches.   Following  bedding
      and seeding the beds should be thoroughly
      wet using furrow irrigation.
          Issued:  4-01-86
                       1-036601-7
                                94

-------
             i=.PA CC'fnpenal urn  of  Acceptable Uses

                         DIPHENAMID
Si_te_,_ jDosage and
Forrnu 1 at i on
(I'c a. i . / A)

  Tomato (continued)

    4-6
    (SO'/- WP5
    (4 ib/gai FiC)
    6
    ooy. WP)
    (4 Ib/oal FIC)
    4-6
    (SO*, 90% WP)
    (4 Ib/nal FIC)
    LSLND
    4-6
    <50'/., 90'/. WP)
 i.olerance.  Use, uirnitat: ions
 Use limited to CA.  Preplant  application.
 Broadcast to cirect-seeded  tomatoes.
 Apniy in 30 to 50 gallons of  water per
 acre.   Incorporate into the soil  to a
 death of £ to 3 incnes.  Do not  use the
 trifluralin tank mix on soils containing
 more than 5 percent organic matter,  or
 soils with a salt problem.  Tank  mix with
 trifluraiin or peculate.

 Use limited to CA.  Broadcast application
 to fields prepared in the fail  for early
 spring planting of direct seeded  tomatoes.
 Apply prior to the start of the  winter-
 rainy season (October or November).   Do
 not incorporate into the soil rnecnanicai —
 ly.   Tomatoes may be planted  through March
 1 in the treated fields.  Do  not  use a
 fall application on fields  to be  planted
 after March 1.

 Use limited to Cft.  Broadcast application
 at planting or immediately  after  without
 soil incorporation.  After  application,  i
 to £ inches of water should be  applied by
 sprinkler irrigation.

 SLN - Use limited to CA.
 Prep1ant application.  Apply  once per sea-
 son in at least 3O gallons  of water per
 acre.   Tank mix with naDrooarnide.
Issued:  4-01-86
1-036601-8
95

-------
                       bpft Corriosndi urn  of  ftcceotable Uses

                                  DIPHENflMID
          Si-e,  Dosase and
          Forrnulat ion
          (Ib a. i. /ft)
 'oierance,	Use.	Lirnita-c ions
          TERRESTRIAL NONFOOD CROP
            (ftor icu_l t iiral Crops,)
/£600>ififi
            i ooacco
              4-6
              (5054, 80%, 90S WP)
              (4 Ib/gal F1O
              £-4
              (4 Ib/oal F1C)
              £-4
              (50'/., SO'/., 90S WP)
 Do not graze treatea areas.
 General .In/format ion:  Rainfall or overneaa
 irrination within a week of treatment will
 enhance herbicidal effectiveness.  When  ap-
 plied more than £ days after transplanting
 tillage is required before or at time of
 treatment to destroy germinating weed
 seeds.  Small grain cover crops  planted  in
 the fall following treatment may be  in-
 jured.  When these crops are to  be grown,
 a band treatment to tobacco is recommend-
 ed.   Do not use more than a total of 8
 pounds active ingredient per acre per sea-
 son.

 Broadcast application to seedbeds.   flpply
 at seeding to control white clover.  Use
 the lower dosage on coarse soils and the
 higher dosage on medium/fine soils.  May
 be tank mixed with rnetalaxyl.

 Broadcast.  ftpply from 0 to 7 days before
 transplanting or up to 7 days after  trans-
 planting.   Incorporate into the  top  £ inch-
 es of soil.  ftpply in £0 to 4O gallons of
 water per acre.   May be tank mixed with
 trichlorfon.
              OR
 Broadcast or band treatment at layby fol-
 lowing last cultivation,  usually 4 to 6
 weeks after transplanting.  If application
 was used before or after transplanting ap-
 ply £ to 4 pounds active ingredient  per
 acre.   May be tank mixed with pebulate.

 Pretransplant.   ftppiy up to 7 days before
 transplanting.   Tank mix with trichiorfon,
 isopropalin,  pendirnethal in, or pebuiate.

 Band treatment  at layby.   ftppiy  to row mid-
 dles following  last cultivation.  Do not
 spray tobacco leaves as injury may occur.
 Tank mix with oryzalin.
          Issued:  4-01-86
1-036601-9
96

-------
                       ±. ;-' H  LJ '_< r
          Site, Dosage and
          Formal at ion
          (1 b a. i. /ft)
         YiDendiuffi of ficceptaole  Uses

              DIPHENflMID
                i o
 olerance. Use, Limitations
            Tobacco  (continued)
              4-6
                    80%, 90'/.
              4-6
              (5054,
90'/. WP)
Band treatment at  layby.   Apply  to row
middies following  last  cultivation.   Do
not spray tobacco  leaves  as  injury may
occur.   Tank mix with metaiaxyl.

SLN - Use limited  to i\iC,  SC  and  VA.
Broadcast.  Apply  before  transplanting,  af-
ter transplanting, or at  layby to suppress
common ragweed.  Use the  lower dosage on
coarse mineral soils and  the higher dosage
on medium/fine mineral  soils.
             (Ornamental Plants  and  Forest  Trees)

/3100IDA    flfrican Daisy
/31017DP    filyssum
/310£6Dft    Qst er
/310£8Dfl    Baby's Breath
/31034Dfl    Begonia
/31045DB    Butterfly Orchid
731051 DP)    California Poppy
/31065DR    Chrysanthemum
/31077DO    Cosmos
/31084Dfi    Pah 1 i a_s
/311OODfl    Feverfew
/31i08Dfl    Geranium
/31413DR    Heliotrope
/3i£87Dfi    Indian Laurel
/311S9DPI    Larkspur
/314110ft    Lily-pf-the-Nile
/31133DPI    Lobel ia
/3141£Dfi    Loosestrife
/31137DP)    Marigold
/31151DA    Peonies
/31154DA    Petunias
/31155DO    Philodendron
/31156DA    Phlox
/31171Dft    Salyia
/31iSODfl    Shasta Daisy
/31184DA    Snapdraoon
/311SeDft    Stocks
/31198DA    Sweet William
/31i£O6Dfl    Verbena
/31410DO    Yellow Foxglove
/31£13Dft    Zinnia
          Issued:  4-O1-86
              1-036601-10
                            97

-------
                       EPft Compendium  of  ficceptabie  Uses

                                  DIPHENftPlID
/353£4Dfl
/350940ft
/350£lDfl
/350££Dft
/340££Dft
/350£5Dft
/340£5Dft
/340£8Dfl
/350£7Dft
/350£8Dft
/350300ft
/350310ft
/35O3£Dft
/34£6£Dft
/340310ft
/353590ft
/340350ft
/35460DA
/340360ft
/35£73Dft
/353840ft
/34158DA
/340400ft
/350390ft
/35£35Dft
/340450ft
/35133DA
/35056DA
/349840ft
/343600ft
/354740ft

/34O50DR
/350430ft
/340510ft
/350500ft
          Site. Dosage
          Forrnulat ion
          
-------
                       EPP CornneriGiu.nl  of  Pcceprable Uses

                                   DIPHENifiMID
To lerance
/34053DA
/35360DA
/34056DA
/340570ft
/34058DA
/3505£DA
/34060DA
/3406£DA
/34£46DA
/3536£DA
/34067DA
/341000ft
/350680ft
/340700ft
/350700ft
/3407£Dft
/340730ft
/340750ft
/354580ft
/351850ft
/340800ft
/341900ft
/3507£Dft
/350730ft
/34£15Dft
/340880ft
/340890ft
/35i9£Dfl
/340900ft
/35083DA
/344160ft
/340940ft
/351-96Dft
/353610ft
/340970ft
/350860ft
/340980ft
/350890ft
/350930ft
/3410£DA
/35367DA
/35£540A
/353100ft

/350580ft
/350590ft
/353530ft
/35£55Dft
          Site, Dosage arid
          Formal at ion
          (Ib a. i. /ft)
  Aleppo Pine cluster (continued)

  Euonyrnus
  Fern Podccarsus
  Fett er-B-.ish
  Ficus
  Firsthorn
  Flowering A1 mor;d
  Flowering Currant
  Forsythia
  har 1 andsT Bpxujppg
  Hawaiian Tree Fern
  Heath
  Heavenly Bamboo
  Hemlock
  Hoi ly
  Honeylocust
  Honeysuckle
  Hydrangea
  India Hawthorn
  Jacaranda acutifolia
  Japanese B1ack Pine
  Japanese Holly
  Japanese Snowball
  Japanese Yew
  Juni per
  Laurel
  Li gustrum
  Li lac
  London Plane
  Mahonia
  Maple
  Mirror Plant
  flock Orange
  Mont e r e y P_ i n e
  ftloreton Bay Fig
  Mount a i n-Laure1
  Mugho Pine
  Multiflora Rose
  Norway friaple
  Dak
  Oleander
  01ive (ornament a1)
  Oriental ftrboryitae
  Ornament a1 Evergreen
                                     se.
                                         _ i rr.it at ions
   Pear
  Peacn (ornament a1)
  Pear (ornamental)
  Pecan (ornament a1)
  Pin Oak

Issued:  4-01-86
                                   1-036501-1£
                            99

-------
             EPft  Compendium of Hccep^;able Uses
                         DI?~!lNAr<:ID
Sits. Dosace and
rprrnul at ion
( 1 b a. i . / ft)
                        "!>'! grange.  USB., • ..irn i va':; ions
  ftleopo	Pine cluster  (continued)
/350980ft
/ 3 4 1 1 £ D ft
/ 3 4 4- £ 8 D ft
/ 3 4 i i 3 D A
/350600ft
/35£04Dft
/35105DA
/35103Dft
/ 3 5 1 0 4 D ft
/345550ft
/341£ODft
/34£08Dft
/341££Dft
/341£4Dft
/35£06Dft
/340680ft
/35£09Dft
/34£09Dft
>"35£liDft
/353640ft
/341300ft
/341£lDft
/3413£Dft
/351 170ft
/351180ft
/35119DA
/342190ft
/351£ODfl
/341370ft
/344150ft
/341400ft
/34££4Dft
/35££7Dft
/35£48Dft
/351£5Dft
/351£8Dft
/351300ft
/35£53Dft
  Pine
  P in e a p o 1 e G a a y a
  P i nn I ncJ i an Ha wt horn
  Pit •bCjS_gor_iJifj'i
PI urn
Red...
        (ornamental)
  Red Dak
  Reel bud
  Red cedar
  R h o d o d en a r o n
  Rose
  SaK.aki.
  Santiankwa Viburnum
  Sasanq ua Came Ilia
  Scarlet Oak
  Scotch Heather
  Shore Juniper
  Shrub-ftlthea
  Silver Maple
  Spineless Yucca
  S'pirea
  St. Johnswort
  Star Jasmine
  Sugar Maple
  Sweetqurn
  Sycamore
  Tobira
  Tul iptree
  Viburnum
  Victoria-Sox
  Heiqela
  Uiei qela (bristol ruby)
  White ftsh
  Ujhite Birch
  Whit_e Cedar
  Willow
  Yew
  Yew Podpca_rpJ-_LS

    4-8
     (50%,  90'/. WP)
     (1.39 Ib/oal F1C)
                        Broadcast.   flpoly in the  fall  or  serin;! be-
                        fore weeds emerge.   May ae dilutee  in 10
                        gallons of water.
Issued:  4-O1-86
                       I-0366O1-13
                                                                100

-------
                        cPA  Lorn pencil am of Acceptable L'sss

                                   DIPHENAtfID
          Site, Dosage  arid
          Formalat ion
           (Ib  a. i. /ft)

/33053AA    ft1 peri an  Ivy  (ground
             cover)
33059flft     Baby1s  Tears  (ground
             cover)
/33086ftA    Bio Blue Lily Turf
             (ground cover)
/33110AA    Bugleweed  (ground
             cover)
/33060ftfl    Ceanothus  (ground
             cover)
/33061ft!-)    Cinauefoi 1  (around
             cover)
/33130ftft    Dwarf Coyotebrush
             (ground covsr)
/33030ftft    Enq1ish  Ivy (ground
             cover)
/33i£BAA    Gasania  (ground  cover)
/331£4AA    Ice Plant  (ground
             cover)
/331£7AA    Juni per  (ground  cover)
/33O44Aft    Per JVM ink le  (ground
             cover)
/331£5flfl    Stonecrop  (ground
             cover)
/33106ftfl    Strawberry  (ornament-
             al)  (ground cover)

               0. 5-£. 0  Ib a. i. /
               5, 000 sq.ft
               (50%,  8094, 90% WP)
               (1.39, 4  Ib/gal
               F1C)
 Tolerance,  Use, -.1,"nit-at ions
 Broadcast application to  new  and
 established plantings.  For new  plantings,
 apply after cuttings have rooted  (usually
 1 month after planting).   For established
 plantings, apply in the fall,  early win-
 ter,  or spring before weeds emerge.   Re-
 neat  treatment in 6 months.
               1. £5  Ib  a. i. /5, 000
               sq. ft
               (£. 3'/. G)

/ 33017 Aft    Berrnudaqrass

               0. 5 Ib a. i. /5, 000
               sq. ft
               (50'/., 90'/. WP)
               (4  Ib/gal F1C)
 Preplant application.  Broadcast.   Do no'
 use where plants are to  be  grown from
 seed.
 Formulated with carbaryl.
 Broadcast.   Apply to established  berrnucia-
 grass.   Apply in the fall  to  control  annu-
 al blueqrass and in the  spring  to control
 crabqrass.   Make early spring applications
 while berrnudagrass is still dormant.
           Issued:   4-01-86
1-036601-14
101

-------
/3504£DA
/35051BA
/350680ft
/35074DR
/35098DA
/35il6Dfi
          Site, Dosage and
          Forrnul at ion
          (Ib a. i. /ft)
Cypress
Fir
Hemlock
Larch
Pi ne
Sorace
               Lornpend i urn of  Hcceptable  Uses

                       DIPHENftMID

                       Tolerance?,  Use, Lirni t at ions
              £-10
              (50%, 90* WP)
              (4 Ib/gal F1C)
Senera 1 In format i on:   ihese  sites  iriciuae:
Baldcypress, Balsam-Fir,  Douglas—Fir,
Frasier Fir, Grand Fir,  Noble  Fir,  Red
Fir,  White Fir,  Rocky  Mountain Douglas-
Fir,  Eastern Hemlock,  Western  Hemlocx,
Japanese Larch,  Western  Larch,  Austrian
Pine, Loblolly Pine, Lodgepoie Pine,
Long leaf Pine, Monterey  Pine,  Ponderosa
Pine, Scotch Pine, Short leaf Pine,  Slash
Pine, Sugar Pine, White  Pine,  Enc iernann
Spruce,  Norway Spruce, and White Spruce?.
If application is made 1  day before or
within £ days after  seeding  a  second 10
pound active ingredient  per  acre treatment
may  be applied & weeks after seeding.   For
cypress and spruce apply  after seedlings
are  1 month old.   Use  only post plant in- ap-
plications on ftustrian Pine.

Broadcast application  to  nursery seedbeds.
Apply 1 day prior to seeding to within i
month after seeding  and  mulching.   ftpply
0.5 to 0.75 inch of  water by overhead
sprinkler irrigation.  Work  all weed
growth into soil before  application.
          Issued:  4-01-86
                      1-036601-15
                                                                   102

-------
                        =.PH Lorn penc i urn of fie ce p~ a31 s Lses

                                   DIPHENfiMID -
          Site, Dosage  and
          Form LI 1 at ion
          (Ib a. i. /ft)

/330£Sftft    Dichondra
               1. £  Ib  a. i. /5, 000
               sq. ft
               (1. 4£'/.  G)
               (SO'/., 80%,  30V. WP)
               (1.33,  4  Ib/gal
               FIC)

               CMfilli
               1 Ib  a. i. /5,000
               sq. ft
               (3.4V/.  G>

               CMfilJ
               1. 00-1. £5  Ib a. i. /
               5, 000  sq.ft
               (£. 3'/.,  £.
               6)
               CMflID
               1  Ib a. i. /5, 000
               sq. ft
               (3.5-/. G)
 tolerance. Use, •_r.rnitat ions
 General Information:  Do  not  use on grass
 lawns.   ftpply when  foliage  is cry.

 Preplant application  to seedbeds or broad-
 cast treatment to established dichondra.
 For preolant treatment preaare seed DSC and
 rake in 0.5 inch deep before  seeding.   A
 second application  may be made in 6
 months.  For established  dichondra.  apply
 in the spring before  weeds  germinate and
 again  in the fall.  Repeat  application
 every 4 months.  May  be dilutee witn £ to
 10 gallons of water.
 May be formulated with rnonuron.

 Preplant application  to seedbeds or broad-
 cast treatment to established dichondra.
 ftpply throughout the  year.
 Formulated with one or a  combination of
 the following:  neburon,  rnonuron.  and car-
 baryl.

 Use limited to Cft.  Posternergence.   Broad-
 cast,   ftpply in winter, spring or fall to
 established dichondra.  Make  £ applica-
 tions,  6 to S weeks apart,  to control
 emerged weeds.  To  control  spurge and crab-
 grass both applications must  be rnace be-
 fore mid-March in southern  Cft,  late March
 in the Interior Valley, and before mid—
 ftpril  in northern Cft.  Do not apply to new-
 ly seeded dichondra and do  not plant di-
 chondra seed sooner than  £  months after ap-
 plicat ion.
 Formulated with neburon,  rnonuron,  and chlo-
 ropyri fos.
          Issued:  4-01-86
1-036601-16
103

-------
                        irPfl  Compendium of flcceptaoie Uses

                                   DIPHENflMID

          Site, Dosage  arid          Tolerance,  Use, Li mi's at ions
          Formulat ion
          (Ib a. i. ,'P)

          aERIPL flND TflNK KIX  ftp PL. I CATIONS

900l500     fierial Application

              —                    Refer to

                                    TERRESTRIAL FDDD CROP
                                     (flgricult ural Crops)
                                    Peppers,  Potatoes, Tomatoes

'3900300     Tank friix

              —                    Refer to
                                    TERRESTRIAL FOOD CROP
                                     (flqricultural Crops)
                                    Peanut,  Soybean,  Sweet Potatoes,  Tomatoes,
                                    Tobacco
                                                                104
          Issued:  4-01-86         1-036601-17

-------
                        iiPH Cornoend i urn of Acceptable uses

                                   DIPHENAMID

          Listing  of  Registered Pesticide  Products  by Formalat ion

&097. OOOi 97'/- technical chemical
            di phenarnid (036601)
              045639-001£7*
              *jacket  currently unavailable for  review

&090. 000£ 90'/. formulation intermediate
            diDhenarnid (036601)
              045639-00106

&095. 00OS 95'/. f orrnu 1 at i on i nt errned i at e
            di phenarnid (036601)
              045639-00 IE'0

&-OOi.4£04 1.4S'/.  granular
            di phenarnid (036601)
              000557-01740

&00£. 3004 £. 3'/- Granular
            di phenarnid (036601) plus carbaryl  (056801)
              01094^-00004

            di phenarnid (036601), rnonuron  (035501)  plus carbaryl  (056801)
              01094£-OOOO3

&00£. 6504 £. 65'/-  granular
            di phenarnid (036601) plus carbaryl  (056801)
              000538-00031*+
              •frjacket  currently unavailable for  review
              -i-suspended

&003.4404 3.44%  granular
            d i ph enarri i d (036601) plus nion uron  (035501)
              003£34-0003£

&003.5004 3.5% granular
            di phenarnid (036601), neburon  (01S001),  rnonuron  (0355O1 )  plus
             chloropyrifos (059101)
              OO0538-OO1££

&005. 0004 5'/. granular
            di phenarnid (036601)
              (011440-00001)        NC80003£*
              *jacket  currently unavailable for  review

&005. 3004 5. 3'/. granular
            di phenarnid (036601), neburon  (012001)  plus carbaryl  (056801)
              000538-0004£
          Issued:   4-01-86        1-036601-18
105

-------
                        EPA  Compendium of Acceptable Uses

                                   DI PHENAiyilD

          Listing of  Registered  Pesticide Products by Formulation  (continues)

&£5O. 0006 SO'/- wet table  powder
            diphenarnid  (036601)
              000070-OOS3S   000 i9£-00139   000££6-00££6   000264-00353
              00£393-00345   00£393-0043B   045633-00107   045639-00 i :• i

               (045639-00107)        CA7S0050*? CA7S0056  CS790107  NCB00005*
                                    N C 6 0 0 0 0 6 *f S C S 0 0 0 0 i *f S C 6 0 0 0 0 £ & V A 6 0 0 0 0 6
                                    Vft300010
                wdouble parent  iaoei

&£80. 0006 SO'/, wet table  powder
            diphenarnid  (036601)
              00£393-00346   0£34B6-00049*
                *see  auxiliary  documentation

&£90.0006 90% wettable  .powder
            d i pheriarnid  (036601)
              000070-00£37   000££6-00£45   045639-00131   045639-00133

               (045639-00131)        C07B0050* CA7901BO  NCSOOOOSfc iNiCB00006i*
                                    SCBOOO01S SC80000£# VflS00009  VflSOOOll
                #double parent  label

&£lfl. 301£ IB. 3'A emulsif iable concentrate
            diphenarnid  (036601)  plus dinoseb,  triethanolarnine salt (037506)
              045639-0011B*
              *jacket currently  unavailable for review

&•£ 15. 4014 15.4'/. (1.39 1 b/ga_l)_ f lowable concentrate
            diphenarnid  (036601)
              00019£-00140   045639-00117

&£4£. 5014 4£. 5'X (4  1 b/qal)  f lowable concentrate
            diphenarnid  (036601)
              n01Bl£-00£B£
9999999   State Label Registrations

            Cfi Reg. No.
              007001-07762    007159-OB£79   011093-07367    011149-0467£

            NY Reg. No.
              038655-10441    03B655-10444
          Issued:  4-01-B6         1-036601-19
106

-------
             tPA l_-ornpentii urn of Acceptable uses

                         DIPHENftMID

                        Appendix ft—1

Listing of Active  Ingredient(s) Found in Combination with  the
 Report Chemical

                                                    EPA  Acceptable
                                                Common/Chemica 1  Name
Chemical
Code
056301
053101
035501
01 £001
Common Name
(source)
carbary 1
ch loropyr i f os
rnonuron
neburon
— Use Common  Name
 Issued:   4-01-86        I-036601-SO

-------
             C.PH Compendium of  Acceptable Uses

                        DIPHENAMID

                       Appendix ft—£

Listing of Active Ingredient(s)  Which  May Be Included in Tank Mixes
Chern i ca 1    Common Name
  Code        (source)
029901

OIS301



037505

0375O6

100201

035506

113501

103001



104201

O41403



108501

098901


036101
ch lorarnben

ch iorpropharn



d inoseb

dinoseb, triethanolarnine salt

isopropal in

1inuron

rnetalaxy 1

napropamide



crysal in

pebulate



pend imethalin

trichlorfon


tri fluralin
                                        EPA Acceptable
                                    Common/Chemical Narne
isopropyl N-<3-
ch loropheny 1 ) carbarn-
ate
IM, N-diethyl-£-(l-
napthalenyloxy) pro-
pi onarnide
S-propyl
buty lethy 1 th iocarbarna
te
1,£—ben z i sot h i a z o1i n-
3—one
— Use Common Name
Issued:  4-O1-86
            I-036601-21
                                                       108

-------
                        BIBGUIDE-1

          GUIDE TO USE OF THIS BIBLIOGRAPHY
CONTENT OF BIBLIOGRAPHY.  This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard.  Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions.   Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.

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

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

FORM OF ENTRY.  In addition to the Master Record Identifier
(MRID) , each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission.  Bibliographic conventions used reflect  the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
                                109

-------
                        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
    wich'no  question marks,  the Agency  took it directly
    from the document.  When a four-digit date is  followed
    by a question mark, the  bibliographer deduced  the
    date from evidence in the document. When the  date
    appears  as  (19??), the Agency was unable  to  determine
    or estimate the date of  the document.

c.  Title.   In  sone 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 s.tudy
         appears.  The six-digit accession  number follows
         the symbol "CDL," standing for "Company Data
         Library."  This accession number is in  turn
         followed by an alphabetic suffix which  shows  the
         relative position of the study within the volume.
         For example, within accession  number 123456,  the
         first  study would be 123456-A; the second, 123456-
         B;  the 26th, 123456-Z; and the 27th, 123456-AA.


                                  110

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

00018842 Atkins, E.L., Jr.;  Anderson,  L.D.;  Greywood, E.A.  (1969) Effect of
            Pesticides on Apiculture:  Project No.  1499; Research Report CF-
            7501.  (Unpublished study  received May 8, 1971  under 1F1174;
            prepared by Univ.  of California—Riverside, Dept. of Entomology,
            submitted by Ciba  Agrochemical Co.,  Summit, N.J.; CDL:090973-B)

00026700 Holifield, E.; Barrow, K.;  Clark, R.C.; et al. (1974) Residue:
            Enide 50W.  (Unpublished study received Aug 1,  1974 under
            1023-23; submitted by Upjohn  Co., Kalamazoo, Mich.; CDL:
            005407-C)

00029335 Upjohn Company (1966)  Summary: Residue  Analysis.   (Unpublished
            study received Mar 3, 1966 under 1023-23; CDL:005473-A)

00031791 Stephenson, J.E.; Deloatch,  F.;  Majett, G.B. (1975) Summary of
            Residue Data for the Sequential  Application of  Vernam + Enide
            + Dinitro on Peanuts.  (Unpublished  study received Aug 11, 1976
            under 476-2155;  prepared in cooperation with Morse Laboratories,
            Inc., submitted by Stauffer Chemical Co., Richmond, Calif.;
            CDL:225431-B)

00035595 Holifield, E.L.; Hogan,  W.H.;  Stone,  W.J.H.; et al. (1970) Residue
            Determination for  Oiphenamid  and Desmethyldiphenamid on Peanut
            Hulls:  Report No.  119-9760-17.   (Unpublished study including re-
            port nos. 119-9760-18,  119-9760-19,  119-9760-24..., received
            Jun 12, 1970 under OF0933;  submitted by Upjohn  Co., Kalamazoo,
            Mich.;  CDL:091591-E)

00035596 Hogan, W.H.; Stone, W.J.H.;  Holifield,  E.L.; et al. (1970) Residue
            Determination for  Diphenamid  and Desmethyldiphenamid on Sweet
            Potatoes: Report No.  119-9760-14.  (Unpublished study including
            report nos. 119-9760-15,  119-9760-20,  119-9760-21..., received
            Jun 12, 1970 under OF0933;  submitted by Upjohn  Co., Kalamazoo,
            Mich.;  CDL:091591-F)

00035601 Upjohn Company (1964)  Stability  of  Diphenamid in Frozen Produce.
            (Unpublished study received Jun  12,  1970 under  OF0933; CDL:
            091592-E)

00035602 Upjohn Company (1963)  Stability  of  Diphenamid in Frozen Macerated
            Peanut.  (Unpublished study received Jun 12, 1970 under OF0933;
            CDL:091592-F)

00035603 Upjohn Company (1963)  Stability  of  Diphenamid in Frozen Macerated
            Sweet Potato.  (Unpublished study received Jun  12, 1970 under
            OF0933; CDL:091592-G)
                                            111

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

00035605 Staten, F.W.;  Cox,  B.L.  (1968)  A  Modified Method for the Residue
            Analysis of Diphenamid and Desmethyl diphenamid in Green Forage
            Crops: Report No.  116-9760-41.  Method dated Sep 12, 1968.  (Un-
            published study  received  Jun 12,  1970 under OF0933; submitted by
            Upjohn Co., Kalamazoo,  Mich.;  CDL:0391592-J)

00035607 Wardowski, W.F.; Niedbalski,  J.F.  (1969) Residue Determination for
            Diphenamid on Apples:  Report No.  112-9760-9.  (Unpublished study
            including report no.  112-9760-24,  received Jun 12, 1970 under
            OF0933; submitted by  Upjohn Co.,  Kalamazoo, Mich.; CDL:091592-L)

00035608 Holifield, E.L. (1969)  Residue Data  for Diphenamid on Cotton and
            Cottonseed.  (Unpublished study including report nos. 112-9760-
            28, 112-9760-49, 112-9760-48...,  received Jun 12, 1970 under
            OF0933; submitted by  Upjohn Co.,  Kalamazoo, Mich.; CDL:091592-M)

00035609 Holifield, F..L. (1959)  Residue Data  for Diphenamid on Okra.  (Un-
            published study  including report  no. 112-9760-50, received Jun
            12, 1970 under OF0933;  submitted  by  Upjohn Co., Kalamazoo,
            Mich.; CDL:091592-N)

00035610 Hogan, W.H.; Bowers,  R.C.  (1969)  Residue Data for Diphenamid and
            Desmethyldiphenamid  on Peaches: Report No. 112-9760-35.  (Un-
            published study  including report  no. 112-9760-34, received Jun
            12, 1970 under OF0933;  submitted  by  Upjohn Co., Kalamazoo,
            Mich.; CDL:091592-0)

00035611 Staten, F.W.;  Hogan,  W.H.; Holifield, E.L.; et al. (1969) Residue
            Data for Diphenamid  on Peanuts.   (Unpublished study including
            report nos. 112-9760-40,  112-9760-41, 112-9760-39..., received
            Jun 12, 1970 under OF0933;  submitted by Upjohn Co., Kalamazoo,
            Mich.; CDL:091592-P)

00035612 Wardowski, W.F. (1969)  Residue Determination for Diphenamid on Ap-
            ples:  Report No. 112-9760-10.   (Unpublished study received Jun
            12, 1970 under OF0933;  submitted  by  Upjohn Co., Kalamazoo,
            Mich.; CDL:091592-Q)

00035647 Holifield, E.L.; Niedbalski, J.F.; Hogan, W.H.; et al. (1968) Res-
            idue Determination for Diphenamid, DNBP and Desmethyl diphenamid
            on Peanuts:  Report No.  116-9760-36.  Includes method dated Mar
            2, 1964.   (Unpublished  study including report nos. 116-9760-30,
            116-9760-28, 116-9760-44..., received Jun 13, 1970 under OF0933;
            submitted by Upjohn Co., Kalamazoo,  Mich.; CDL:091593-A)
                                        112

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

00035648 Wardowski, W.F.; Holifield,  E.L.;  Niedbalski, J.F.; et  al.  (1969)
            Residue Determination for Diphenamid  on  Soybeans: Report
            No. 112-9760-32.   (Unpublished  study  including  report  nos. 112-
            9760-17, 112-9760-2, 112-9760-5..., received Jun 13, 1970 under
            OF0933; submitted by Upjohn Co., Kalamazoo, Mich.; CDL-.091593-B)

00035649 Chambers, E.E.; Staten, F.W.; Holifield,  E.  (1968) Residue Study--
            Sweet Potatoes.   (Unpublished study including report no. 112-
            9760-1, received  Jun 13,  1970 under OF0933; submitted  by Upjohn
            Co., Kalamazoo, Mich.;  COL-.091593-C)

00043703 Boyack, G.A.; Lemin, A.J.; Staten, F.W.;  et al. (1966)  Determina-
            tion of N,N-Dimethyl-2,2-diphenyl acetamide  (Diphenamid) in plant
            tissues using gas-liquid  chromatography.  Journal of Agricultur-
            al and Food Chemistry 14(3):312-314.   (Also in  unpublished sub-
            mission received  Feb 21,  1968 under 8F0708; submitted  by Upjohn
            Co., Kalamazoo, Mich.;  CDL:093015-A)

00053607 Schulz, J.E.'(1968)  Cataractogenic Studies .(Leghorn Chickens).
            (Unpublished study received on  unknown date under unknown admin.
            no.; submitted by ?; CDL-.105547-B)

00073539 Upjohn Company (1968) Residues:  Enide SOW in Sweet Potato Plants.
            (Compilation; unpublished study received Nov 1, 1965 under
            1023-23; CDL:024408-C)

00075382 Woodard,  M.W.; Woodard, G.;  Cronin, M.T.I.  (1966)  Diphenamid Safety
            Evaluation by Dietary Feeding to Dogs  for 103 Weeks.   Final
            rept.   (Unpublished study received Jan 29,  1967 under  7F0585;
            prepared by Woodard Research Corp., submitted by Upjohn Co.,
            Kalamazoo, Mich.; CDL:090749-D)

00076383 Woodard,  M.W.; Woodard, G.;  Cronin, M.T.I.  (1966)  Diphenamid:
            Three-generation  Reproduction Study in Rats.  (Unpublished study
            received Jan 29,  1967 under 750585; prepared by Woodard Research
            Corp., submitted  by Upjohn Co., Kalamazoo, Mich.; CDL:090749-E)

00077881 Johnston, R.L.; Schwikert, R.S.; Ceru, J.G.  (1960) .Letter sent to
            E.S. Feenstra dated Nov 10,  1960: U-4513  (acetamide, N,N-di-
            methyl-2,2-dipheny1-) powder and 0.1%  suspension.  (Unpublished
            study  received Nov 8, 1965 under unknown  admin, no.; submitted
            by Upjohn Co., Kalamazoo, Mich.; CDL:109751-C)

00077893 Eberts, F.S.; Weeks, R.C.; Vliek,  R.W. (1964) Letter sent to A.A.
            Forist dated Feb  21, 1964:  Metabolism  of C14-labeled Enide in
            the rat.  (Unpublished study  received Nov 8, 1965 under unknown
            admin, no.; submitted by  Upjohn Co., Kalamazoo, Mich.; CDL:
            109751-P)

                                         113

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

00083606 DuBois, K.P.;  Kinoshita,  F.  (1965)  The Acute Toxicity of Bayer
            37289 in Combination with Other  Anticholinesterase Agents to
            Adult, Female Rats:  Submitter  15983.   (Unpublished study re-
            ceived Apr 7, 1970 under  OF0869;  prepared by Univ. of Chicago,
            Dept. of Pharmacology, submitted by Mobay Chemical Corp., Kansas
            City, Mo.;  CDL:091498-U)

00093606 Upjohn Company (1967)  Metabolism  of Diphenamid: Summary, and Dis-
            cussion.  Summary of studies 090751-C  through 090741-1.  (Un-
            published study  received  on unknown date under 7F0585; CDL:
            090751-A)

00093608 Lemin, A.J. (1966)  Absorption, translocation, and metabolism of
            diphenamid-l-C14 by  tomato seedlings.  Journal of Agricultural
            and Food Chemistry  14(2):109-111.  (Also in unpublished sub-
            mission received Jan 29,  1967  under 7F0585; submitted by Upjohn
            Co., Kalamazoo,  Mich.; CDL:090751-D)

00093609 Go.lab, T.; Herberg, R.J.; Parka,  S.J.; et al. (1966) The metabolism
            of carbon-14 diphenann'd in strawberry  plants.  Journal of
            Agricultural  and Food  Chemistry  14(6):592-596.   (Also in un-
            published submission received  Jan 29,  1967 under 7F0585; sub-
            mitted by Upjohn Co.,  Kalamazoo,  Mich.; CDL-.090751-F)

00093614 Upjohn Company (1967)  The Results of Tests on the Amount of Residue
            Remaining,  Including a Description of  the Analytical Method
            Used: Diphenamid in  Strawberries.  (Compilation; unpublished
            study received on unknown date under 7F0585; CDL:090750-B)

00105710 Johnson, W.; Griggs; Turner  (1975)  Residue Data on Trifluralin and
            Diphenamid When  Trefmid Plus Dymid Is  Preplant Soil Incorporated
            for Weed Control in  Direct-seeded Tomatoes.  (Unpublished study
            received Apr 28, 1975  under 1471-68; submitted by Elanco Prod-
            ucts Co., Div. of Eli  Lilly and  Co., Indianapolis, IN; CDL:
            101101-A)

00106180 Mobay Chemical Corp. (1976)  Addition No.  1 to Brochure Entitled:
            Sencor: Residue  Chemistry on Tomatoes: Document No. AS76-549.
            (Compilation;  unpublished study  received May 6,-1976 under
            6F1783; CDL:095907-A)

00114560 Johnston, R.;  Ceru, J.  (1963) Study: N,N, Dimethyl-2,2-diphenyl-
            acetamide Toxicity  to  Rats:  U-4513.   (Unpublished study
            received Feb 8,  1963 under 1023-23; submitted by Upjohn Co.,
            Kalamazoo,  MI; CDL:005458-B)


                                        114

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

00114566 Upjohn Co.  (1965)  Study:  Diphenamid Residue on Specified Crops.
            (Compilation;  unpublished  study received Mar 8, 1965 under 1023-
            23; CDL-.005471-A)

00114570 Upjohn Co.  (1969)  Residues  of Diphenamid  in Potatoes and Other
            Crops.  (Compilation;  unpublished study received Dec 12, 1969
            under 1023-23;  CDL:005478-B)

00114575 Upjohn Co.  (1967)  Toxicity  of Enide to Mice and Other Subjects.
            (Compilation;  unpublished  study received May 16, 1968 under
            1023-45; CDL:005487-G)

00114577 Upjohn Co.  (1969)  Residues: Summary and Discussion: Enide.
            (Compilation;  unpublished  study received Jan 8, 1969 under
            1023-45; CDL:005489-H)

00114585 Upjohn Co.  (1965)  Summary of  Analyses for Diphenamid Residue.
            (Compilation;  unpublished  study received Jul 1, 1967 under
            8F0627;  CDL:090820-A)

00114586 Upjohn Co.  (1968)  Residues  of Diphenamid  in Cattle, Milk and
            Other Products.  (Compilation; unpublished study received
            Jul 22,  1968 under 8F0708; CDL:091227-A)

00114588 Upjohn Co.  (1958)  The Results of Tests on the Amount of Residue
            Remaining,  Including a Description of  the Analytical Method
            Used: Diphenamid.   (Compilation; unpublished study received
            Jul 22,  1968 under 8F0708; CDL:091227-C)

00114590 Elanco Products Co.  (1968)  The Results of Tests on the Amount of
            Residue  Remaining, Including a Description of the Analytical
            Method Used: Diphenamid.   (Compilation; unpublished study
            received Oct 30,  1968  under 8F0717; CDL:091240-A)

00114594 Upjohn Co.  (1967)  Diphenamid  Residue Analyses in Various Crops.
            (Compilation;  unpublished  study received Aug 15, 1967 under
            7F0585;  CDL:092873-B)

00114600 Upjohn Co.  (1965)  Requests  for Registration of Enide (Diphenamid):
            Book II.  (Compilation;  unpublished study received Feb 10, 1965
            under 1023-23;  CDL:101552-A)

00114601 Upjohn Co.  (1964)  Supplement: Residue Determinations: Request for
            Registration of Enide  (Diphenamid).  (Compilation; unpublished
            study received Jan 20, 1964 under 1023-23; CDL:101553-A)
                                          115

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

00114602 Upjohn Co.  (1966)  Residues  of Diphenamid  in Raspberries.  (Com-
            pilation;  unpublished study  received May 17, 1966 under 1023-23
            CDL:101562-A)

00114613 Crabtree, R.  (19??)  To Establish  a Technique for Handling Radio-
            active Diphenamid in the Growth Room:  Experiment G33:54.  (Un-
            published study received on  unknown date under unknown admin.
            no.; submitted  by Elanco Products Co., Div. of Eli Lilly and
            Co., Indianapolis,  IN; CDL:120270-E)

00133452 Staten, F.  (1963)  Determination of N,N-dimethyl-2,2-dipheny1-
            acetamide in Tomato Using Gas  Liquid Chromatography.  (Unpub-
            lished study received Mar 7, 1963 under unknown admin, no.;
            submitted by Upjohn Co., Beaver Falls, PA; CDL:120231-A)

00138963 Johnson, W.;  Finley,  M. (1930)  Handbook of Acute Toxicity of Chem-
            cals to  Fish and  Aquatic Invertebrates.  By U.S. Fish and Wild-
            life Service.   Washington, D.C.: USFWS.  Resource publication
            137,

00157344 Repenthin,  W.  (1986)  Hydrolysis of N,N-dimethyl-2,2-diphenyl-   .
            acetamide (Diphenamid) at pH 1 and 13  at 25[Degrees]C and at pH
            5,7 and  9  at 49[Degrees]C: Bericht Nr. APC 06/85.  Unpublished
            study Schering  AG.   20 p.

40200701 Schultz, D.;  Tweedy,  G.  (1972) The Effect of Light and Humidity
            on Absorption and Degradation  of Diphenamid in Tomatoes.
            J. Agr.  FoodChem.,  (20:1) 10-13.
                                        116

-------
                                                                                 OMB Approval No. 2000-0453 (Expires  12-31-83)
                 FIFKA SECTION 3(C)(2){B) SUMMARY SHEET
                                                                                          EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
                                  DATE GUIDANCE DOCUMENT ISSUED
  With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
  Guidance Document, I am responding in the following manner:
     CD 1.  I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
           specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
           Chemicals Testing Programme, I enclose the protocols that I will use:
     D 2.  I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
           requirements. The tests, and any required protocols, will be submitted to EPA by:

  NAME OF OTHER REGISTRANT
     G 3.  I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
           respect to the following data requirements:
     D4.  I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
     D 5.  I request voluntary cancellation of the registration of this product (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
                                                                                                              DATE
EPA Form 8580-1 (10-82)
                                                                         117

-------
OMB Approval No. 2000-0468 (Expires: 12-3 1-83.
                                                                                                                             8'
CERTIFICATION OF ATTEMPT TO ENTER i
INTO AN AGREEMENT WITH OTHER REGISTRANTS i
(To qualify, certify ALL four items) FOR DEVELOPMENT OF DATA
1. 1 am duly authorized to represent .the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM




GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMPANY NUMBER

i
'
.
(This firm or group of firms is referred to below as "my firm".)
 2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer  to erne:  jj
    into an agreement with one or more other registrants to develop jointly, or to share  in the cost of developing, the following  required  j
    items or data:                                                                                                                 •
 3.  My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to be
    bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
    to the following firm(s) on the following date(s):
                                       NAME OF FIRM
                                                                                                     DATE OF OFFER
 However, none of those firm(s) accepted my offer.

 4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
   have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
   me whether my firm must submit data  to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
   does not apply to applicants for new products.)  I give EPA permission to disclose this statement upon request.
TYPED NAME
                                                       SIGNATURE
                                                                                                            DATE
EPA Form 8580-6 (11X82)
                                                                           118

-------
                            PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
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 comp lying with
data requirements by
Citing MRID
Number or
EPA Accession
Number


















Submit-
ting
Data
(At-
tached)


















(For EPA Use Only)
MRI-D Numbers
Assigned


















                                           119

-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§138.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corros ion
characteristics
Dielectric break-
down voltage

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









•






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
















Submit-
ting
Data
(At-
tached)
















(For EPA Use Only)
MRID Numbers
Assigned








_







120

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

                    GENERIC DATA EXEMPTION STATEMENT

EPA Product Registration Nunber: 	

Registrant's Name:	.

   and Address:                      	
    As an authorized representative of the registrant of the product
identified above, I certify that:
                                                   »
    (1)1 have read and am familiar with the terms of the Notice fron EPA
dated	concerning a requirement for submission of generic data
on the active Ingredient naned under PIPRA sec. 3(c)(2)(B).

    (2)  Hy 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 PIPRA sec. 3,
and which is purchased by us frcm another producer.
      v
    (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 CSP 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
    Viy firm will apply for an amendment to the registration prior to
changing the source of the active Ingredient In  our  product.

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

Registrant's authorized representative:	
                                                    Signature

Dated: 	•                     	        •  	
                                                    (Typed;
                                          121

-------