united sum
Enviranmwnai Protection
Aocncy
Pwtickta «nd Toxic Submncw
Wa^iinqton OC 20460
                           March 1987
PacticidM
Guidance for the
Reregistration of
Pesticide Products
Containing Vendex
as the Active Ingredient

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          GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS

             CONTAINING

          FENBUTATIN-OXIDE
       (TRADE NAME - VENDEX)
      SHAUGHNESSY NO.  104601
             MAR 3 I 1987

      AS THE ACTIVE INGREDIENT
        CAS NO.  13356-08-6

          CASE NUMBER 0245
    ENVIRONMENTAL PROTECTION AGENCY

    OFFICE OF PESTICIDE PROGRAMS

      WASHINGTON, D.C.  20460

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                        TABLE OF CONTENTS
I.     Introduction	    1

II.    Chemical(s) Covered by this Standard 	    4
        A.  Description of Chemical
        B.  Use Profile
III.  Agency Assessment  	   6
        A.  Summary
        B.  Preliminary  Risk Assessment
        C.  Other Science Findings
        D.  Tolerance Reassessment

IV.   Regulatory Position and Rationale	   18
        A.  Regulatory Positions
        B.  Criteria for Registration
        C.  Acceptable Ranges and Limits
        D.  Required Labeling

V.    Products Subject to this Standard	   28

VI.   Requirement for Submission^of Generic Data  	   30
        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   .  .   35

VIII. Requirement for Submission of Revised Labeling  	   36

IX.   Instructions for Submission	   37
        A.  Manufacturing use products (sole active)
        B.  Manufacturing use products (multiple  active)
        C.  End use products
        D.  Intrastate products
        E.  Addresses

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                           APPENDICES

I.  DATA APPENDICES

    Guide to Tables

    Table A

    Table B

    Table C


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  Formulator's Exemption Statement
                                  11

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                       I.  INTRODUCTION






     EPA has established the Registration Standards program



in order to provide an orderly mechanism by which pesticide



products containing the same active ingredient can be reviewed



and standards set for compliance with 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.' St.andardA..._	



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.

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     2.  Additional studies necessary to support continued

registration.  The additional studies may not have been

required when the product was initially registered or may be

needed to replace studies that are now considered inadequate.

     3.  Labeling revisions needed to ensure that the product

is not misbranded and that the labeling is adequate  to protect

man and the environment.

     The detailed scientific review, which is not contained

in this document, but is available upon request-'-, focuses on

the pesticide active ingredient.  The scientific review

primarily discusses the Agency's evaluation of  and conclusions

from available data in its files pertaining to  the pesticide

active - ingredient-. -:..Howe-v.er.,<,,during,»th.e^r.ev.iew  of,^these.v,da,ta.-.,

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

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 steps  to  be taken by registrants to maintain their registrations

 in  compliance with FIFRA.  These steps may include:

      1.   Submission of data in support of product registration;

      2.   Modification of product labels;

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

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

      5.   Modification of uses or formulation types; or

      6.   Specification of packaging limitations.

      Failure to comply with these requirements may result in

 the issuance of a Notice of Intent to Cancel or a Notice of

 Intent to Suspend (in the case of failure to submit data).

      In addition, in. cases in which hazards to man or the

 environment are identified, the Agency may initiate a special

 review of the pesticide in accordance with 40 CFR Part 154

 to examine in depth the risks and benefits of use of the

 pesticide.  If the Agency determines that the risks of the

 pesticide's use outweigh the benefits of use, the Agency

 may propose additional regulatory actions, such as cancellation

 of uses of the pesticide which have been determined to cause

 unreasonable adverse effects on the environment.


     EPA has authority under the Data Call-in (DCI) provisions

 of FIFRA-sec. 3(c)(2)(B) to require that registrants submit

 data to answer our questions regarding the chemical, toxicological

 and environmental characteristics and fate of a pesticide.

This Registration Standard lists the data EPA believes -are

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necessary to resolve'our concerns about this pesticide.

These data are listed in the Tables A, B,  and C in Appendix I.

Failure to comply with the DCI requirements enumerated in

this Registration Standard may result in issuance by EPA of a

Notice of Intent to Suspend the affected product registrations.

     Registrants are reminded that FIFRA sec. 6(a)(2)  requires

them to submit factual information concerning possible unreason-

able adverse effects of a pesticide at any time that they

become aware of such information.  Registrants should notify

the Agency of any information, including interim or preliminary

results of studies, if those results suggest possible adverse

effects on man or the environment.  This requirement continues

as long as their products are registered by the Agency.


          II.  CHEMICAL(S) COVERED BY THIS STANDARD

A.  Description of chemical(s)

    The following chemical is covered by this Registration
Standard:
    Common name:     Fenbutatin-oxide
    Chemical name:   Bis [tris(2-methyl-2-phenylpropyl)tin] oxide
                     or hexakis (2-methyl-2-phenylpropyl)-
                     distannoxane
    CAS Number  :     13356-08-6
    OPP (Shaughnessy)  Numbers:  104601
    Empirical Formula:  CgoH78OSn2
    Trade and        Vendex, Fenbutatin oxyde, SD 14114, Torque,
    other names:     Neostanox,  Osadan and Hexakis
    Description of physical characteristics of chemical:

    Technical Fenbutatin-oxide

    Color:   White
    Odor:   Odorless
    Physical State:  Crystalline solid

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    Melting point:  145°C
    Solubility:  Insoluble in water and slightly soluble in
                 aromatic sovents
    Molecular Weight: 1053

B.  Use Profile
    Type of Pesticide: Organotin acaricide, refer to Pesticide
                       Index (Appendix III).
    Predominant Use(s): Oranges, grapefruit, pears,  apples, grapes,
                        almonds, cherries, strawberries and
                        ornamentals
    Mode of Activity:  It is suspected that fenbutatin-oxide
                       inhibits adenosine triphosphate (ATP) enzymes.

    Methods of Application:  Foliar application by ground equipment
                             only

     Fenbutatin-oxide is the common name for hexakis (2-methyl-

2-phenylpropyl) distannoxane and this common name will be

used through out this Guidance Document.  Fenbutatin-bxide

is a non-systemic organotin acaricide that has been marketed

in the United States for 12 years and is used to control more

than 20 different types of mites on about 17 sites.   All

fenbutatin-oxide registrations were recently transferred from

Shell Chemical to E.I. du Pont de Nemours and Company.


There are 3 registered products with the following formulations:

      Technical (97%)
      Wettable Powder (50%)
      Flowable Concentrate (4 Ib/gal)


     Fenbutatin-oxide is used on a variety of use sites which

include:'almonds, apple, cherry, citrus fruits, eggplant,

grapes, papaya, peach, pear, pecan, plum, prune, strawberry,

walnut and ornamentals.  Recommended application rates range

from 0.5 pounds active ingredient (a.i.) per acre to 2.0

pounds a.i. per acre.

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                    III.  AGENCY ASSESSMENT



 A.   SUMMARY





      The Agency has reviewed data submitted to support the



 registration of fenbutatin-oxide and concluded that numerous



 data gaps exist for fenbutatin-oxide.  However, based on



 available data the Agency has reached the following conclusions.



 (A  detailed discussion of the points summarized below appears



 in  Section B.)





 1.    A primary eye irritation study demonstrat.es that technical



 fenbutation-oxide is a severe eye irritant and is therefore



 classified as a Toxicity I chemical based on eye effects only.



. The Agency .believes^, that the. p.r;e,cau,ti£mar,y.,.s.ta,temeji.ts_iCQncerning,..,



 these eye effects presently on-fenbutatin-oxide labels are



 adequate to protect the public.





 2.    Available data demonstrate that the use of fenbutatin-oxide



 in  citrus groves may present a chronic hazard to nesting and



 foraging birds and an acute hazard to freshwater and estuarine



 aquatic organisms.  Until the required data are developed



 and submitted, hazards can be reduced through labeling statements,



 (Refer to Section IV A for a description of the required data).





      The. Agency has identified the data it feels is necessary



 to  fully evaluate the human and environmental risks associated



 with the use of fenbutatin-oxide.   These data must be developed



 in  order to maintain registrations, of. products or .to register



 new products containing fenbutatin-oxide.  A summary of  these

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data gaps appears in Figure I.  Please note that this is only

a summary and complete details can be obtained by referring

to the tables in Appendix I.

     The Agency has also determined that certain label re-

strictions and revisions are necessary.  Please refer to

Section VI.D. for a description of the required labeling

revisions.

                   Figure 1- DATA GAP TABLE
Toxicology

Acute Oral (Rat)
Acute Inhalation (Rat)
90 Day Feeding  (Non-rodent)
21 Day Dermal Toxicity
Chronic Toxicity (Non-rodent)
Oncogenicity (Mouse)
Mutagenicity
General Metabolism Testing"
2-Generation Reproduction
       Environmental Fate

       Leaching
       Hydrolysis
       Photodegradation (In water)
       Photodegradation (On soil)
       Aerobic and Anaerobic Soil
       Soil Metabolism Studies
       Volatility (Lab)
      'Soil Dissipation"*-' '*  '"
       Rotational Crops (Confined)
       Accumulation in Fish
Re-entry

Foliar Dissipation
Product Chemistry/Residue Chemistry

Product Chemistry
Animal Metabolism
Storage Stability
Residue Studies
                       Ecological Effects

Avian Subacute Dietary Toxicity
Avian Reproduction
Freshwater Fish Toxicity
Acute Toxicity to Freshwater Invertebrates and
Fish Early Life Stage and Aguatic Invertebrate
Aguatic Organism Accumulation Testing
Simulated or Actual Field Testing for Aguatic Organisms
                     Marine Organisms
                     Life Cycle

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                                8
B.   PRELIMINARY RISK ASSESSMENT





     The Agency has reviewed fenbutatin-oxide data in the areas



of acute toxicity, chronic toxicity, oncogenicity, reproductive



effects, mutagenicity, environmental fate and exposure, and



ecological effects.   Numerous data gaps exist.  The following



assessment is based on available data and is subject to change



when the results of the required studies are available for



Agency review.  (Refer to Section C for a detailed discussion



of other science findings not covered in the Preliminary



Risk Assessment Section).





1.  Toxicology



    a.  Eye Irritation



    Six male Albino rabbits were administered 100 mg of



undiluted technical fenbutatin-oxide in the conjuctival sac



of the treated eye.  All animals showed damage to the cornea,



iris and conjunctiva up to 14 days post treatment.  Based



upon this primary eye irritation study, technical fenbutatin-



oxide is characterized as a severe eye irritant and is clas-



sified as a Toxicity Category I chemical because of eye



effects.





2.  Ecological Effects



      Birds



     An acute oral avian toxicity study indicates that



fenbutatin-oxide,  when administered orally  in a single dose,



is practically nontoxic to birds.  "The LD5Q value for-'Bobwhite-



Quail is 2510 mg/kg.

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     A subacute dietary toxicity study on Mallard ducks



likewise supports a finding indicating that fenbutatin-oxide



is nontoxic to birds.  The LC^Q value for Mallard ducks is



greater than 5620 parts per million (ppm). (A subacute dietary



toxicity study using Bobwhite Quail must be repeated because



the administered dose was not sufficient to calculate a



reliable LCso value).





      Aquatic Organisms





     Preliminary freshwater invertebrate acute toxicity



data indicate that fenbutatin-oxide is highly toxic to fresh-



water invertebrates.  This study was classified as supplemental



data-and must be repeated because the test water was not



properly characterized and only 3 dose levels, rather than



5 levels, were used.   The tentative LD5Q value for Daphnia



magnia is 0.04 ppm.





     Acute toxicity data on Rainbow trout and Bluegill sunfish



indicate that fenbutatin-oxide is highly toxic to freshwater



fish.    The LCso value for Rainbow trout is 0.0017 ppm.  The



LCso value for Bluegill sunfish is 0.0048 ppm.





      Wildlife Exposure and Hazard





     The "highest application rates for fenbutatin-oxide are



applied to citrus crops in Florida at a  rate of 2 Ibs active



ingredient per acre.  Use directions allow for up to 4 total



applications to citrus with each application being 2 to 3



weeks  apart.

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                                 10
       The  Agency  is  carefully  evaluating  f enbutatin-oxide



 use  on citrus  for the  following  reasons:





      a.  Repetitive  applications  could  result  in an ac-



 cumulation of  parent f enbutatin-oxide and metabolites  that,



 because  of the persistent  nature  of  the pesticide, may present



 a  chronic  hazard  to  birds  foraging in soils and nesting  in



 citrus groves.





      b.  Although run-off  does not appear to present a risk



 to aquatic species,  spray  drift  resulting from application



 of fenbutatin-oxide  to  citrus  groves may  pose  an acute toxicity



 hazard to  freshwater and estuarine species.
..... The -Agency- i-S'^



aquatic and avian  toxicity  testing,  chronic  toxicity  testing



as well as aquatic field monitoring  studies  be  conducted



before the wildlife  risk assessment  can  be completed.   (Refer



to Appendix I for  a  complete  listing of  required  data).





C.   OTHER SCIENCE  FINDINGS





1 .   Acute and Subchronic Toxicity



     Available dermal  toxicity data demonstrate  that  fenbutatin-



oxide exhibits  low toxicity to mammals by dermal  route  of



exposure*  The  acute  dermal toxicity to  rabbits is greater



than 2,000 mq/kg.



     Data are sufficient to  indicate  that fenbutatin-oxide  is



not  a dermal sensitizer*  Primary dermal' irritation  data. ,



demonstrate that fenbutatin-oxide is a mild  skin  irritant.

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                                   11
    No valid acute oral toxicity, acute inhalation,  90 day



feeding (non-rodent) or subchronic dermal toxicity studies.



are available.  These data are required.





2.  Chronic Toxicity



      Rat



     An acceptable 2 year rat feeding study, where 72 male



and 72 female Carworth rats were administered fenbutatin-oxide



in dietary doses of 50, 100, 300 and 600 ppm for 104 weeks,



demonstrated that fenbutatin-oxide was not oncogenic under test



conditions.  One hundred forty-four animals of each sex were



used as controls.  A systemic No Observed Effect Level (NOEL)



of 100 ppm (or 5 mg/kg) was established based on decreased leuco-



cytes in female rats and reduced body weight in both sexes



receiving dosages greater than 300 ppm.



      Non-rodent



     A 2 year dog feeding study^was reviewed and found to be



supplemental because of reporting deficiencies.  The study may



be upgraded when the required information listed in Appendix I



is submitted and reviewed.



     In this study, male and female dogs  (4 animals per sex



per dose)  were administered fenbutatin-oxide in gelatin



capsules "containing 2.5, 5, 15, 30 and 60 mg/kg.  The control



group consisted of 8 animals per sex.



     These preliminary data indicate that the NOEL is considered



to be 5 mg/kg/day with a lowest effect level of 15 mg/kg/day



based on clinical observations of vomiting and diarrhea.

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                                  12
 3.   Oncogenicity

       Rat

      The rat chronic/oncogenicity study previously described

 in  Section C2 adequately assesses the oncogenicity of  fenbutatin-

 oxide.  No oncogenic effects were demonstrated at doses  up to

 600 ppm, the highest level tested).

       Mouse

      An 18 month feeding/oncogenicity study was reviewed and

 found to be supplemental because of  reporting  deficiencies.

 The study may be upgraded when the required information

 listed in Appendix I is submitted and reviewed.  Sixty male

 and sixty female Carworth mice were  fed diets  containing 5,

 100, 300, 600 ppm of fenbutatin-oxide.   A control group  of

 120 male and 120 female mice received an untreated diet.

      Preliminary data indicate that  the NOEL is 100 ppm

 based on decreased body weight.   No  oncogenic  effects  were

 reported at the highest dose tested.


 4.   Reproductive and Teratogenic Effects

       Reproduction

      There are no valid reproduction  studies available to
\
 assess reproductive effects from fenbutatin-oxide exposure.

 This study is required.

       Teratology

       Rat

      An acceptable rat teratology study demonstrates that

 fenbutatin-oxide is not teratogenic  in the rat.  The NOEL for

 this study is 60 mg/kg, the highest  dose tested.

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                                   13
     One hundred ''thirty s ix  fema 1'e ""Wfsfcar:'~*ra'ts -were" adm'rrf- - *"~-' —
 istered fenbutatin-oxide  by  gavage  at doses  of  15,  30  or  60
 mg/kg from  6 through 15 days of pregnancy.   Fifteen  female
 rats were administered aspirin which served  as  the  positive
 control.
      Rabbit
 •     ———
     A rabbit teratology  study was  reviewed  and found  to  be
 acceptable.  Female New Zealand White rabbits were  administered
 fenbutatin-oxide  in gelatin  capsules at  doses of 1,  5,  and  10
 mg/kg on days 6-18 of gestation.  Thalidomide was given as  the
 positive control.  The NOEL  for this study as 5 mg/kg.

 5.   Mutagenicity and Metabolism

     There  are "no"valid- mat-a-ge-nicity-->or~me-tabol-isTn~studtesr »"~»—
 available.  These studies must be conducted  and submitted to
 the Agency.

 6.  Environmental Fate                           ;

     The available data are  insufficient to  fully assess  the
 environmental fate of fenbutatin-oxide.   Refer  to Appendix I  for
 a listing of required data.

 D.  Tolerance Assessment

    1. Tolerances issued
     Tolerances have been established  for residues of fen-
butatin-oxide in a variety of  raw  agricultural  commodities
including meat, fat and meat by  products  (refer to 40 CFR-:
180.362 for listing of tolerances),  and  in processed food (21
CRF 193.236) and feed  (21 CFR  561.255).

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14
Commodity
Almonds
Almonds, hulls
Apples
Cattle ,f at
Cattle, meat
by product
Cattle, meat
Cherries, sour
Cherries, sweet
Citrus fruits
Cucumber
Eggplant
Eggs
Goats, fat
Goats, meat by
product
Goats, meat
Grapes
Hogs, fat
Hogs, meat by
products
Hogs, meat
Horses, fat
Horses, meat" by
product
Horses, meat
milk fat
Papayas
Pecans
Peaches
Pears
Plums
Poultry, fat
Poultry, meat by
products
Poultry , meat
Prunes
Sheep, fat
Sheep, meat by
products
Sheep ,meat
Strawberries
Walnuts
Apple pomace, dried
Citrus pulp, dried
Grape pomace, dried
Raisin waste
Prunes, dried
Raisins
Tolerance- '(ppnr)-"
U.S. Canadian Mexican
0.5
80.0
15.0 3.0
0.5
0.5

0.5
6.0
6.0
2.0 2.0
4.0 0.5
6.0
0.1 -
0.5
0.5

0.5
5.0
0.5
0.5

0.5
0.5 . -
- 0.5 ' " "- '

0.5
0.1
2.0
0.5
10.0
15.0
4.0
0.1
0.1

0.1
4.0
0.5
0.5

0.5
10.0
0.5
20.0
7.0 -
100 - •
20.0
8.0
20.0 -
• - ~(-MRL)
Codex
—
-
5.0
-
-

0.02
5.0
5.0
5.0
1.0
1.0
-
-
-

—
5.0
-
—

—
-
-

-
-
-
-
7.0

3.0
-
-

—
-
-
-

—
—
-
-
—
—
—
-
-

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                                   15
    2.	Resrdue -Da ta"" -ra-'
     The residue data reviewed in support of these fenbutatin-



oxide tolerances are:



     a.  Data on the nature of the residue in both plants and



animals, including identification of major metabolites and



degradates of fenbutatin-oxide.



     The nature of the residue of fenbutatin-oxide in animals



is not adequately understood because: (1) insufficient residue



levels were present in milk and meat of dairy cows for charac-



terization/ (2) residues in laying hens were not properly



characterized due to problems with analytical methodology,



and (3) no material balance information was provided for



residues recovered from laying hens.   The limited data do



show that up to 82% of fenbutatin-oxide residues were recovered



from the feces of dairy cattle that were fed diets containing



radiolabeled fenbutatin-oxide.  No detectable fenbutatin-oxide



residues or metabolites were detected in milk, fat or muscle



of cattle and less than one percent of the total administered



dose occured in the lungs, liver, kidneys and urine combined.



Characterization of residues in the liver and kidney revealed



the presence of fenbutatin-oxide per se, dihydroxy-bis(2-methyl-



2-phenylpropyl) stannane and inorganic tin.



     A fe'nbutatin-oxide hen feeding study indicated that



fenbutatin-oxide residues were found in egg yolks, liver



and kidney.   Due to problems with analytical methodology



and residue recovery, however, a new study must be conducted



and submitted.

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                              16
     The metabolism  of  fenbutatin-oxide  in plants is adequately



 understood  and  no  additional  data  are  required.   Available



 data demonstrate that fenbutatin-oxide residues  (fenbutatin-



 oxide,  dihydroxy-bis-(2-methyl-2-phenylpropyl) stannane,



 2-methyl-2phenylpropyl  stannonic acid  and other  organic and



 inorganic compounds) were  detected in  treated  leaves and



 fruit of apples and  oranges.



     Tolerances of fenbutatin-oxide are  currently expressed



 as  the  combined residues of hexikis (2-methyl-2-phenylpropyl)-



 distannoxane  and its organotin  metabolites.  Upon receipt of



 the required  animal  data,  the tolerance  expression will be



 re-evaluated.





..., —b ~ --Adequate  •ga^s'-rrqurd-'^ftrcmat'ograpfric -(GLC) methods-	



 utilizing either a tin-specific flame  photometric detector



 or mass selective  detector are  available for collection of



 data pertaining to residues of  fenbutatin-oxide  and its



 organotin metabolites.  A  method trial for two procedures is



 needed  for  the  determination  of fenbutatin-oxide and its



 metabolites.  Data for  residues of fenbutatin-oxide and its



 organotin metabolites in or on  crop samples  must be analyzed



 using the multiresidue  methods  published in  PAM, Vol.  I.





     c.  Storage stability data demonstrate  that the metabolites



"dihydrbxy-bis ^-me^hYl-^'-ph-efiypr'opyt^s-tannane-^and 2-met-hyl—-"-•'



 2-phenylpropyl  stannonic acid were stable in frozen chicken



 tissue  and  egg  samples  stored at -10°F for up  to four months.

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                                17..
 order  to  evaluate  the  adequacy  of  numerous  established



 tolerances.



     d.   Data  on the magnitude  and levels of  residues of



 fenbutatin-oxide are sufficient to determine  the  adequacy



 of  the established tolerances for  residues  of fenbutatin-oxide



 in  or  on  almonds,  almond  hulls,  apples,  cherries  (sweet and



 sour), citrus  fruits,  eggplant,  grapes,  papayas,  peaches,



 pears, pecans,  plums,  raspberries,  strawberries and  walnuts.



 There  are not  sufficient  data available  to  ascertain the



 adequacy  of  the established  tolerances for  residues  of  fen-



 butatin-oxide  in or on cucumbers.   Processing studies are



 required  for apples, citrus  fruits,  grapes  and plums.



-•-	  Because  ^'''ttpe^TTUmeTOu^-xesidue'-^tie^



 the Agency cannot  conduct a  tolerance reassessment until



 the required data  are  received  and reviewed.





     2. Toxicology





     A 2  year  rat  feeding study, originally used  to  support



 the previously established tolerances for residues of fenbuta-



 tin-oxide, has been re-evaluated and found  to be  acceptable



 to  continue  supporting the existing tolerances.   Based  upon  a



 No  Observed  Effect Level  (NOEL)  of 100 ppm  for systemic



 effects,  and using a 100  fold safety factor,  the  Acceptable



 Daily  Intake (ADI) was calculated  to be  0.05  mg/kg/day.   (An



 ADI rather than a  PADI, or provisional ADI, was used because



 available data, deemed to be supplemental due ,,to  reporting

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                                18
deficiencies,  demonstrate  that  the  no effect  level of 100 ppm
"i s ~ not ' l:l*ke"ly  to' "cif a:htre%>^
The MPI  (Maximum  Permissible  Intake),  for a 60 kg individual
was found  to be 3.0 mg/kg/day.   The Theoretical Maximum Residue
Contribution (TMRC) for  all published tolerances was  calculated
to be 0.0357 mg/kg/day for a  1.5 kg diet.   The TMRC utilized
71.4% of the ADI.
     Because of the extensive residue chemistry and toxicology
data gaps,  the Agency cannot  conduct a full tolerance reassess-
ment.  The  tolerances will be reassessed  when the required
data are received and reviewed.

            IV. REGULATORY POSITION AND RATIONALE
A.  REGULATORY POSITIONS AND  RATIONALES
......  Based" on a rfeviW'-'aivdrevaM^t^TiFXJf^a^
and other relevant  information  on  fenbutatin-oxide,  the
Agency has made the  following determinations:

1.   The Agency is  requiring the submission  of  acute aquatic
toxicity data and aquatic  field monitoring data on  the end
use formulations and  aquatic life  stage  data and avian
reproduction data on  the technical formulation.

Rationale
     Based on acute  toxicity data,  use pattern, and modeling
information, the use  of fenbutatin-oxide in  citrus  groves may
present a chronic hazard to nesting and  foraging birds and an

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                                 9
acute hazard to freshwater and estuarine aquatic organisms.



Upon receipt of the required data, the Aqency will complete



the hazard assessment.





2.  The Agency is imposing a 24 hour reentry interval and is



requiring that protective clothing statements for all



fenbutatin-oxide products be revised to include labeling



language for early reentry into treated fields.



(Refer to Section IV D for specific labeling requirements).





Rationale



     As required in PR Notice 83-2, fenbutatin-oxide product



labels currently prohibit workers from reentering treated



fields without protective clothing unless sprays have dried.



However, because of a few California incidence reports and



the fact that this chemical is acutely toxic due to adverse



eye effects, the Agency is imposing an interim 24 hour reentry



interval in an effort to further reduce exposure.  It may be



noted that both California and Texas have established 24 hour



reentry intervals.  This interim reentry interval will be retained



until the required reentry data are received and evaluated.





     Technical fenbutatin-oxide is characterized as a severe



eye irritant and is classified as a Toxicity Category I



chemical because of eye effects.  The Agency is requiring



that these statements be modified and upgraded to further



protect persons involved in early reentry into treated fields.

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                                 20
3.   No significant new food uses* will be granted until the

Agency has received sufficient data to evaluate the dietary

exposure to fenbutatin-oxide.


Rationale

     The Residue Chemistry and Toxicology data bases for

fenbutatin-oxide are not sufficient to assess the existing

tolerances.  Animal metabolism and residue data including

processing studies as well as data on various commodities

are required.   The required toxicology data include:  chronic

feeding/ oncogenicity, 2-generation reproduction, mutagenicity

and metabolism testing.  (Refer to Appendix I, for a listing

of required residue chemistry and toxicology data).


4.   The Agency will not require endangered species labeling

at this time.


Rationale

     Since 1982, cotton, corn, small grains, sorghum, soybeans,

rangeland, forest and mosquito larvicide uses have been

reviewed under a cluster approach to determine the endangered

species impacted by certain pesticide uses.  Fenbutatin-oxide,
* Significant new use us defined in 44 FR 27934, May 11, 1979.
  In the case of a new food or feed use, the Agency will
  consider as significant an increase in the Theoretical
  Maximum Residue Contribution of greater than one percent.

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                                 21
however, is not registered for the above listed uses and



therefore, does not .fall under this cluster analysis for




endangered species.






     An analysis of pesticides with similar uses to fenbutatin-



oxide revealed that a number of endangered species were found



to be in jeopardy but based on modeling (exposure concentrations



in this model did not exceed the endangered species trigger),



use information and available toxfcity data, fenbutatin-oxide



does not appear to pose a threat to endangered species.






     Future analysis of uses that have not been reviewed in the



cluster project may necessitate the need for endangered species



labeling.--	~  -  • 	       ....






5.  The Agency has identified certain data that will receive



immediate review when submitted.






Rationale



    Certain data are deemed essential to the Agency's assess-



ment of this pesticide and a review of these data may trigger



the need for further studies which should be initiated as



soon as possible (e.g. tier studies).  The following studies



have been identified to receive priority review as soon as



they are received by the Agency:





158.140 Environemntal Fate



132-1 Foliar Dissipation (Re-entry)

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                                  22
158.145 Ecological Effects

72-4  Fish Early Life Stage and Aquatic Invertebrate Life Cycle
72-3 Acute Toxicity- Aquatic Estuarine and Marine Organism
72-7 Field Testing for Aquatic Organism


6.  The tolerance regulation must be revised to separately list

fenbutatin-oxide and its organotin metabolites.


Rationale

     At present all established tolerances are expressed as the

combined residues of the parent compound and its organotin

metabolites calculated as the parent compound.  The Agency is

requiring that the fenbutatin-oxide organotin metabolites be

listed separately in the tolerance regulation so that established

tolerances can be made compatible.with the Maximum Residue. .  .

Limits (MRL's) established by the Codex Alimentarius Commission,

an organization set up in the United Nations designed to

facilitate international trade.


7.  While data gaps are being filled, currently registered

manufacturing use products (MPs) and end use products (EPs)

containing fenbutatin-oxide as the sole active ingredient may

be sold,  distributed, formulated and used, subject to the

terms and conditions specified in this Standard.  Registrants

must provide or agree to develop additional data, as specified

in the Data Appendices,.an,.order to maintain existing registra-

tions.

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                               25
     No pesticide product containing fenbutatin-oxide may

be distributed, sold, offered for sale, held for sale, shipped,

delivered for shipment, or received and (having so received)

delivered or offered to be delivered by any person after

24 months from receipt of this document unless the product

bears an amended label which complies with the requirements

of this Standard.


     In addition to the above, the following information must

appear on the labeling:

     1.  Ingredient Statement


          The ingredient statement for all fenbutatin-oxide

products must list the active ingredient as:


ACTIVE INGREDIENTS:

Fenbutatin-oxide (Hexakis(2-methyl-2-
                  phenylpropyl)  distannoxane. . .  .	%
INERT INGREDIENTS:
     2.  All products must have a statement of practical

treatment and in the following format:

     If in eyes:  Immediately flush eyes with plenty of
                  water.  Call a physician.

     If inhaled:  Remove from exposure and have patient lie
                  down and keep quiet.  If patient is not
                  breathing, start artificial respiration
                  immediately.  Never give anything to an
                  unconscious person.

     If on skin:  Wash skin with plenty of soap and water.

     If swallowed:  Do not induce vomiting.  Call a physician,

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                               26
Manufacturing Use Product Labeling

1. Use Pattern Statements

     All manufacturing use products must state that they are

intended for formulation into end-use products for acceptable

use patterns.  Labeling must specify sites, which are listed

in the Index in Appendix III.   However, no use may be

included on the label where the registrant fails to agree to

comply with the data requirements in Table A for that use

pattern.

2.  Precautionary Statements

     Labels for manufacturing-use and end-use products must

bear statements reflecting the compound's acute human toxicity.

Fenbutatin-oxide is classified in Toxicology Category I on

the basis of eye irritation only.  All the precautionary labeling

language that is currently on fenbutatin-oxide labels is to be

retained.


3.  Environmental Hazards Statement

     The following revised environmental hazard statement must

appear on all manufacturing use product labels:

     "This pesticide is toxic to fish.  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 NPDES permit.  Do not discharge effluent containing
      this product into sewer systems without previously
      notifying the sewer treatment plant authority.  For
      guidance contact your State Water Board or Regional
      office of the EPA."

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                               27
End Use Product Labeling


a.  Environmental Hazards Statement;

     "This product is toxic to fish.  Do not apply directly to
     water or wetlands (swamps, bogs,  marshes,  and potholes).
     Drift and runoff from treated areas may be hazardous to
     aquatic organisms in neighboring  areas.  Do not
     contaminate water by cleaning of  equipment or disposal
     of wastes."

b.  Reentry Statement;

      "Do not enter treated fields within 24 hours of
       application unless long pants and long-sleeved shirt
       (or coveralls); chemical resistant gloves; shoes;
       and goggles or a face shield are worn."

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                                   28
            V.   PRODUCTS SUBJECT TO THIS STANDARD

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

    Products are subject to this Registration Standard as
 follows:

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

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

      2.  The data requirements listed in Tables A and B2

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

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

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

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

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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 exemption3, the
     data requirements listed in Table C.

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

     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.

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                                 30
       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 submit
 generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
 with the data request.

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

     If you apply for a new registration for products containing
 this active ingredient after the issuance of this Registration
Standard,  you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
4 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.

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                                 31
 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 of
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.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it.   The agreement to produce the data need
not  specify all of  the terms of the final arrangement between
the parties  or a mechanism to resolve the terms.

     If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division.  The request must
include the  following information:

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                                 32
     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:

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

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

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                                 33
      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.
E.  Procedures for requesting a change in testing protocol.

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

     If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time.  Any request for a -time
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing  to
the Product Manager listed at the end of this section and
must be made before the deadline for response.  Once dates
have been committed to and EPA has accepted these commitments,
any subsequent requests for a time extension must be submitted

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                                  34
in writing to the Office of Compliance Monitoring at the
address given in Section IX.E.

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

     The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline.  Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome.  Time extensions
may be considered when joint data development is planned,
or when the Agency must approve a new or modified protocol
before the "study can be begun.

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


G.  Existing stocks provision upon suspension or cancellation.

     The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
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
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.

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                                 35
   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.I. (submit data)
or VI.D.6.(cancellation of registration).

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

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                                  36
    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.

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                                 37
               IX.  INSTRUCTIONS FOR SUBMISSION

A.  Manufacturing Use Products (MUPs) containing FENBUTATIN-
    OXIDE 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.  Foonulator's Exemption Statement (EPA Form 8570-27),
    if applicable.

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

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

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

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

        c.  Three copies of draft labeling, including the
    container label and any associated supplemental  labeling.
    Labeling should be either typewritten text on 8-1/2 x 11
    inch paper or a mockup of the labeling suitable  for
    storage in 8-1/2 x 11 files.  The draft label must indicate
    the intended colors of the final label, clear indication
    of the front panel of the label, and the intended type
    sizes of the text.

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

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                                  38
     3.  Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption.  If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.

B.  Manufacturing Use Products containing FENBUTATIN-QXIDE
    in combination with other active ingredients.

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

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

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

        c.  Formulator's Exemption Statement (EPA Form 8570-27),
    if  applicable.
                          t
                     •
    2.   Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption.  If for any
reason any test is delayed or aborted so that the schedule
cannot  be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.

C.  End Use Products containing FENBUTATIN-OXIDE as sole
    active ingredient.

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

        a.  FIFRA Section 3(c)(2)(B) Summary Sheet, with
    appropriate attachments5 (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.

-------
                                     39
    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).
E.  Addresses

     The required information must be submitted to the following
address:

     Dennis Edwards (PM-12)
     Registration Division (TS-767)
     Office of Pesticide Programs
     Environmental Protection Agency
     401 M St., SW
     Washington, D.C.  20460

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

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

F.  Intrastate Products containing FENBUTATIN-QXIDE 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.

G.  Address

    The required information for intrastate products only must be
submitted to the following address:

     Stuart McArthur
     Registration Support and Emergency Response Branch (TSr767)
     Office of Pesticide Programs
     Environmental Protection Agency
     401 M St., SW
     Washington, D.C.  20460

-------
                                 40

                            TGUIDE-1

                        GUIDE TO TABLES

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

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

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

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

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

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

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

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

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

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

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

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

-------
                                41

                           TGUIDE-2

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

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

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

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

5.  Bibliographic citation (Column 5).  If the Agency has
acceptable data in its files, this column lists the identifying
number of each study.  This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned.  Refer to the Bibliography
Appendices for a complete citation of the study.

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

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

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

-------
                    TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement Test
; Substance
§158.120 Product Chemistry
Product Identity
61-2 - Description of Beginning TGAI
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis TGAI
Physical and Chemical
Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boilina Point TGAI
Use
Patterns
All
All
All
All
All
All
All
All
Does EPA Bibliographic
Have Data? Citation
V
No
No
No
No
No
No
No
No
Must Additional
Data be
Submitted? 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Time Frame
for
Submission
6 Months
6 Months
12 Months
6 Months
6 Months
6 Months
6 Months
6 Months

-------
                                                     TABLE A
                                 GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
Test Use
Substance Patterns
Does EPA Bibliographic Must Additional Time Frame
Have Data? Citation Data be for
I/ Submitted? 2/ Submission
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7
63-8
63-9
63-10
63-11
63-12
63-13
- Density, Bulk Density, or
Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation constant
- Octanol/water partition
coefficient
- pH
- Storage Stability
TGAI All
TGAI or PAI All
PAI All
PAI All
PAI All
TGAI All
TGAI All
No
No
No
No
No
No
No
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
I/ Although product chemistry data may have been submitted in the past, the Agency has determined that these data must be
   resubmitted.  New requirements have been introduced and previously submitted data must be updated.  Therefore biblio-
   graphic citations for the old data are not applicable.
2/ Generic data are required for the following technical formulation :  EPA REG. NO.  201-367.

-------
                                                      TABLE A
                                  GEMERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
Test Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
 Time Frame
     for
 Submission
       158.125 Residue Chemistry
       171-4  Nature of the residue
               (Metabolism)
               - Plants                  PAIRA

               - Livestock               PAIRA
                        Yes

                        Partially
              00113018

              00113018
              00113020
              00113078
              00113029
                 NoV

                 Yes2/
                  18 Months
       171-4  Residue analytical
               methods
               - Plant and Animal
                 Residues
     TGAI &
     Metabolites
Partially
 00026038
 00030349
 00045869
 00045870
 00069881
 00070506
 00077245
 00093721
 00105161
 00105203
 00105204
 00109280
 Yes3/
15 Months

-------
                                                      TABLE A
                                  GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
)ata Requirement
Test Substance
     Does EPA
     Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
   for
Submission
       158.125 Residue Chemistry
       171-4    Residue analytical
               method
                (Continued)
               - Plant and Animal
                 Residues
       171-4   Storage stability data
       171-4   Magnitude of the Residue

               - Crop field trials

               - Fruiting Vegetables ^/
                 (except Cucurbits)
                 Group

                 o Eggplant
     TEP &
     Metabolites
                  00112902
                  00113018
                  00113063
                  00113078
                  00143694
                  00145444
                  00146038
                  00148257
                  00148733
                  00130837

        Partially 00113063
                  00113078
                  00146038
     TEP
Yes
00130837
                                                                                                                          U1
                Yes
                                                                         15 Months
                                                      No
               - Cucurbit Vegetables
                 Group

-------
                    TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
lata Requirement Test Substance
171-4 Magnitude of the Residue
- Crop field trials
(continued)
o Cucumbers TEP
- Citrus Fruits Group TEP
- Pome Fruits Group 11/
o Apples TEP
o Pears TEP
- Stone Fruits 13/
Group
o Cherries (sweet TEP
and sour)
o Peaches . TEP
o Plums (fresh TEP
r»t-iin*><5 \
Does EPA Bibliographic Must Additional
Have Data? Citation Data be
Submitted?


Partially 00146038 YesjV
Partially 00030349 Yes10/
00093721
00105204
00113018
Partially 00030349 Yes12/
'00105204
00113018
Yes 00030349 No
00093721
00105204
00113018

Yes 00026038 No
00112902
Yes 00026038 No
00148257
Partially 00026038 Yes14/
00112902
Time Frame
for
Submission


18 Months
24 Months
24 Months




24 Months

-------
                    TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement Test Substance
171-4 Magnitude of the Residue
- Crop field trials
(continued)
- Small Fruits and 15/
Berries Group
o Grapes TEP
o Raspberries TEP
o Strawberries TEP
- Tree Nuts Group *V
o Almonds TEP
o Pecans TEP
o Walnuts . TEP
Does EPA Bibliographic Must Additional
Have Data? Citation Data be
Submitted?
Partially 00077245 Yes16/
00105203
00113078
Yes 00145444 No
Yes 00069881 No
00071183
00148257
00148733
Yes 00109280 No
00113078
Yes 00105161 No
00109280
00113063
Yes 00105161 No
00109280
Time Frame
for
Submission
24 Months

-------
                                                      TABLE A
                                  GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
Test Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
   for
Submission
       171-4   Magnitude of the Residue
               - Crop field trials
                 (continued)

               - Miscellaneous Commodities

                 o Avocados 17/

                 o Papayas               EP

               - Meat/failk/poultry/eggs
                          Yes

                        Partially
              00045869

              00113078
                  No

                 reserved
                                                                                                                        OO

-------
                                                      TABLE A
                                  GENERIC DATA REQUIREMENTS FDR FENBUTATIN-OXIDE

§158.125 Residue Chemistry - Continued


       I/  The present tolerance regulation should be modified to specifically name fenbutatin-oxide and its metab-
           olites dihydroxybis(2-methyl-2-phenyl-propyl) stannane, 2-methyl-2-phenyl-propyl stannonic acid and
           possibly inorganic tin.
       2/  Metabolism studies in ruminants and poultry fed technical grade [H^Sn] fenbutatin-oxide, which must be
           complety characterized (including impurities) and representative of the technical fenbutatin-oxide
           currently used in commercial formulations.  Animals must by dosed for at least three days with concentrations
           in the diet which will result in sufficient residues in tissues, milk, and eggs for characterization.  Milk
           and eggs must be collected for analysis twice daily, and animals must be sacrificed within 24 hours of
           the final dosing.  The distribution and identity of H^Sn-residues must be determined and guantified in
           the milk, muscle, fat, kidney, and liver of ruminants, 'and in the eggs, muscle, fat, kidneys, and liver of
           poultry. At such time as these studies are completed and submitted the present tolerance regulation should
           be modified to specifically name fenbutatin-oxide and any metabolites of concern.

       3/  Residues of fenbutatin-oxide and its organotin metabolites in or on crop samples must be subjected to
           analysis by the multiresidue methods published in PAM, Vol. I.  Protocols for methods I, II, III, and IV are
           available from the National Technical Information Service under Order No. PB86 203734/AS. Also,                \O
           since the present tolerance regulation is to be modified to specifically name fenbutatin-oxide and metabolites
           of concern, if Toxicology Branch deems that each metabolite must be guantitated separately, then methodology
           for plant and animal commodities including validation data and a method trial will be needed.
                                                                  <.' •
       4/  The storage intervals and conditions of storage of all samples used to evaluate all established
           tolerances for residues of fenbutatin-oxide and its organotin metabolites must be submitted.  These data must
           be accompanied by data depicting the percent decline in residues at the time and under the conditions
           specified for each test.  On receipt of these data, the adeguacy of the aforementioned tolerances will be
           reevaluated.
                                                                  i
       5/  All residue data requested in this Standard must be accompanied by data on the conditions and intervals
           of sample storage.  Fortification recovery data must aiso be included which depict the stability of
           residues of fenbutatin-oxide and its organotin metabolites in appropriate sample substances under the con-
           ditions and for the time intervals used in the tests.  •
        • \                •                                             ,
       6/  Use directions must be proposed, and appropriate supporting residue data submitted for the representative
           group members tomatoes and peppers.

-------
                                                     TABLE A
                                 GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE

158.125 .Residue Chemistry - Continued

      7/  Use directions must be proposed, and appropriate supporting residue data must be submitted for
          melons (cantaloupe or muskmelon) and summer squash.

      8/  Appropriate supporting residue data collected using  an adequate analytical method must be submitted
          for cucumbers.

      9/  The registrant must propose use directions for fenbutatin-oxide on cucumbers and provide appropriate
          supporting residue data (collected using an adequate analytical method).  Residue data must reflect the
          combined residues of fenbutatin-oxide and its organotin metabolites calculated as fenbutatin-oxide
          in or on cucumbers.

      10/ Data reflecting the combined residues of fenbutatin-oxide and its organotin metabolites (calculated as
          fenbutatin-oxide) in dried citrus pulp, wet pulp, molasses, juice, and oil processed from citrus fruit
          bearing weathered residues.  Exaggerated rates may be necessary to achieve these residues in or on the fruits.
          If residues are found to concentrate in dried citrus pu,lp the established food additive tolerance may need to
          be amended.  Ifj residues are found to concentrate in we,t citrus pulp, molasses, juice, or oil, appropriate
          food/feed additive tolerances must be proposed.

      ll/ The available data are sufficient to determine that  a crop group tolerance is appropriate at the
          present time.  <                                        >
                         i
      12/ Data depicting ,the combined residues of fenbutatin-oxide and its organotin metabolites (calculated as
          fenbutatin-oxide) in dried apple pomace and juice processed from apples bearing measurable weathered residues.
          Exaggerated rates may be necessary to achieve these  residues in or on the fruits.  If residues are found to
          concentrate in dried apple pomace the established food .additive tolerance may need to be amended.  If residues
          are found to cqncentrate in juice, an appropriate food additive tolerance must be proposed.

      13/ Conclusions may not be made at the present time because available data in support of the proposed crop
          group tolerance are currently under review.
                                                                 i.
      14/ Tests reflecting the combined residues of fenbutatin-oxide and its organotin metabolites (calculated as
          fenbutatin-oxide in prunes processed from plums (fresh !prunes) bearing measurable weathered residues.  Ex-
          aggerated rates may be necessary to achieve these residues in or on the fruits.  If residues are found to
          concentrate, then the established food additive tolerance may need to be amended.

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                                                      TABLE A
                                  GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE

§158.125 Residue Chemistry - Continued


       15/ Proposed use directions roust be submitted along with appropriate supporting residue data for blackberry
          (Rubus spp.), blueberry, and cranberry.

       16/ Data depicting the combined residues of fenbutatin-oxide and its organotin metabolites (calculated as
           fenbutatin-oxide in raisins, raisin waste, dried grape pomace,  and grape juice processed from grapes bearing
           measurable weathered residues.  If residues are found to concentrate in raisins,  raisin waste, or dried grape
           pomace, the  established food/feed additive tolerances may need  to be amended.   If residues concentrate
           in juice, an appropriate food additive tolerance must be proposed.

       17/ Conclusions  may not be made at the present time because available data in support of the proposed
           tolerance for the combined residues of fenbutatin-oxide and its organotin metabolites calculated as
           fenbutatin-oxide in or on avocados are currently under review.

       18/ On receipt of the data requested in £/ above,  the appropriate nature of tolerances for residues in animal
           products will be determined and, with consideration for any newly found metabolites of toxicological
           concern, the adequacy of the available data regarding ;the magnitude of residues in fat, meat, and meat
           by-products  will be determined.

-------
                    TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement Test Use Does EPA Bibliographic
:' Substance Patterns Have Data? Citation
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1\- Hydrolysis TGAI or PAIRA A,B,F No
Photodeqrada t ion
161-2 - In water TGAI or PAIRA A,B No
161-3 - On soil TGAI or PAIRA A No
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil TGAI or PAIRA A,B,F No
162-2 - Anaerobic Soil TGAI or PAIRA A No
MOBILITY STUDIES:
163-1 - Leaching and TGAI or PAIRA A,B,F Partial 00071228
Adsorp t ion /Desorp t ion
163-2 - Volatility (Lab) TEP A,F No
163-3 - Volatility (Field) TEP A,F No
Must Additional
Data be
Submitted?
Yes
Yes
Yes
Yes.
Yes
Yes/1
Yes
Yes/2
Time Frame
for
Submission
9 Months
9 Months
9 Months
27 Months
27 Months
12 Months
12 Months
15 Months

-------
                                               TABLE A
                           GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
Test
Substance
Use
Patterns
Does EPA Bibliographic
Have Data? Citation
i
Must Additional
Data be
Submitted?
Time Frame
for
Submission
158.130 Environmental Fate - Continued
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-4 - In Fish
165-5 - In Aquatic Non-Target
TEP
TEP
PAIRA
TEP
TGAI or PAIRA
TEP
A,B
A
A
A
A,B
N/A
No
No
No
No
No
No
Yes
Reserved/3
Yes
Reserved/4
Yes
Reserved/5
27 Months
39 Months
12 Months
                                                                                                                  U1
Organisms

-------
                                                     TABLE A
                                 GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE


§158.130 Environmental Fate - Continued

   I/  A study is required on the mobility of aged fenbutatin-oxide residues in sandy loam soil.
   2/  Study reserved pending receipt and review of required laboratory volatility data.
   3/  Study reserved pending receipt and review of required field dissipation data.
   4/  Study reserved pending receipt and review of required confined crop rotation study.
       No interim crop rotation label restriction is being imposed because of the data gap.  Rotation crop uptake data
       are being required in this registration standard.  When acceptable uptake data are received, the Agency will
       assess crop residue uptake and apply appropriate regulatory safeguards.
   5/  Study reserved pending receipt and review of required fish accumulation study.
                                                                                                                          Ln

-------
                                                        TABLE A
                                    GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Date Requirement
Test         Use        Does EPA     Bibliographic
Substance    Patterns   Have Data?   Citation
                                 Must Additional
                                 Data be
                                 Submitted
                                       Time Frame
                                          for
                                       Submission
§158.135 Toxicology

ACUTE TESTING;

81-1 - Acute Oral Toxicity - Rat   TGAI

81-2 - Acute Dermal Toxicity       TGAI
        - Rabbit

81-3 - Acute Inhalation Toxicity   TGAI
        - Rat

81-7 - Delayed                     TGAI
       Neurotoxicity - Hen

SUBCHRONIC TESTING;

82-1 - 90-Day Feeding;             TGAI
        - Rodent, and

        - Non-rodent (Dog)

82-2 - 21-Day Dermal - Rabbit      TGAI
             A

             A
             A

             A

             A
No

Yes


No


No
Yes

No

No'
00112990
00037582
Yes

No


Yes


No/1
No/2

Yes/3

Yes
                                         9 Months
                                                                              9 Months
                                                                                        U~
                                        12 Months
82-5 - 90-Day Neurotoxicity:
        - Hen

        -Mammal
TGAI
             A

             A
No

No
                    No/1

                    No/1

-------
                                                       TABLE A
                                   GENERIC DATA REQUIREMENTS FOR FENBuTATIN-OXIDE
Data Requirement Test
Substance
§158.135 Toxicology - Continued
CHRONIC TESTING:
83-1 - Chronic Toxicity - TGAI
2 species:
- Rodent, and
- Non-rodent (Dog)
83-2 - Oncogenicity - TGAI
2 species:
- Rat (preferred), and
- Mouse (preferred)
83-3 - Teratogenicity - TGAI
2 species:
- Rat
- Rabbit
83-4 - Reproduction - Rat TGAI
2-generation
MUTAGENICITY TESTING
84-2 - Gene Mutation (Ames Test) TGAI
R4-? - Structural Chromosomal TGAI
Use
Patterns
A
A
A
A
A
A
A
A
A
Does EPA Bibliographic
Have Data? Citation
Yes 00037582
00113001
Partial 00037583
Yes 00037582
00113001
Partial 00037581
Yes 00072693
Yes 00079319
No
No
No
Must Additional
Data be
Submitted?
No
Yes/4
No
Yes/5
No
No
Yes
Yes
Yes
Time Frame
Eor
Submission

50 Months

50 Months


39 Months
9 Months
12 Months
        Aberration

84-4 - Other Genotoxic Effects    TGAI
No
Yes
                                                     12 Months

-------
                                                      TABLE A
                                  GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
Test         Use        Does EPA     Bibliographic
Substance    Pattern    Have Data?   Citation
Must Additional
Data be
Submitted?
                                                                                                               Time Frame
                                                                                                                  for
                                                                                                               Submission
§158.135 Toxicology - Continued

SPECIAL TESTING

85-1 - General Metabolism
                               PAI or PAIRA
                        No
Yes
                                                                                                                24 Months
I/   Because fenbutatin-oxide is not an organophosphate chemical and available data indicate that there are no neuro-
     toxicological problems associated with this chemical, data are not needed at this time.

2/   There are adequate chronic toxicity data to satisfy this data requirement.

3/   These studies will not be necessary if adeuquate chronic toxicity studies are submitted.

4/   This study may be upgraded to an acceptable level with the submission of the following data:

       a.  The composition of the test material used in this doq study and the composition of the technical material
       currently marketed and registered product.

       b.  An explanation for carrying out this experiment in two time periods, six weeks apart.

-------
n58.135 Toxicology - Continued


     4/ continued-


         c.  Raw data and;summary tables on urinalysis.
                         t '

         d.  Individual animal data on macroscopic and microscopic lesions with the data presented in parallel
             columns on the same page for the same animal.


         e.  Listing of all tissues examined grossly and micrscopically with a description of all gross lesions
             observed and/ or examined.


         f.  Summary tables for the incidence of macroscopic and microscopic lesions.


         If this information is no longer available a new study must be submitted.


    5/   This study may be upgraded with the submission  of the following data:

                         i
         a.  Analysis of feed administered to treated animals for test material content.


         b.  Measurement of food consumption.
                         i                                                                                                 CO
         c.  Necropsy information.
                         }                                        \
         d.  Adeguate number of tissues subjected to microscopic examination.

                         I
         e.  Summary of incidence table of neoplastic and non-neoplastic pathology based upon number of tissues examined
             by sex and dpse.


         f.  Identification of tissues examined histologiclally and organ weight.


         If this information is no longer available, a new study must be submitted.

                                                                 i
                         !                                        i
                         i

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                                                        TABLE A
                                    GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement ' ; Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
§158.140 Reentry Protection
132-1 - Foliar Dissipation TEP A No
132-1 - Soil Dissipation TEP A No
§158.142 Spray Drift
201-1 - Droplet Size Spectrum TEP N/A No
f
201-1 - Drift Field Evaluation TEP N/A No
Must Additional
Data be
Submitted?
Yes
No/1
No/2
No/2
Time Frame
for
Submission
27 Months
(
>
                                                                                                                         un
I/   Soil dissipation data not required if acceptable foliar data are submitted.
2/   Because this chemical is applied by ground application, only, there are no spray drift requirements.

-------
                    TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement Test
; Substance
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Acute Avian Oral Toxicity TGAI
71-2 - Avian Subacute Dietary TGAI
Toxicity
- Upland Game Bird, and
- Waterfowl
71-3 - Wild Mammal Toxicity TGAI
71-4 - Avian Reproduction TGAI
- Upland Game Bird, and
- Waterfowl
71-5 - Simulated Field Testing TEP
- Mammals, and
- Birds
- Actual Field Testing TEP
- Mammals, and
- Birds
Use
Pattern

A,B/1
A,B/1
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
Does EPA Bibliographic
Have Data? Citation

Yes 00113073
No
Yes 00113074
No
No . -
No
No
No
No
No
Must Additional
Data be
Submitted?

No
Yes
No
No/2
Yes/3
Yes/3
Reserved/4
Reserved/4
Reserved/4
Reserved/4
Time Frame
for
Submission


9 Months

ON
O
24 Months
24 Months





-------
                    TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data
§158.
Requirement
145 Wildlife and
Test Use
Substance Pattern

Does EPA Bibliographic
Have Data? Citation

Must Additional
Data be
Submitted?

Time Frame
for
Submission

Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING
72-1


72-2

72-3


- Freshwater Fish Toxicity
- Coldwater Fish Species,
and :
-Coldwater Fish; Species
i
- Warmwater Fish Species
- Warmwater Fish Species
f
- Acute Toxicity to
Freshwater Invertebrates

- Acute Toxicity to
Estuarine and Marine
Organisms/6
- Fish :
- Mollusk ;
- Shrimp
TGAI
A,B/1
TEP A
(41b/gal FC)
TGAI A,B
TEP A
(41b/gal FC) •
TGAI A,B/1
TEP A
(41b/gal FC)
TGAI
A,B
A,B
A,B
Yes 00113075
No
Yes 00113076
No
No .
No
No
No
No
No
Yes/5
No
Yes/5
Yes
Reserved/5
Yes
Yes
Yes

9 Months
•
9 Months
9 Months

12 Months
12 Months
12 Months

-------
                   TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
§158.145 Wildlife and
Aquatic Organisms -
- Acute Toxicity to
Estuarine and Marine
Organisms/6
- Fish
- Mollusk
- Shrimp
72-4 - Fish Early Life Stage
- Freshwater
- Estuarine
and
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Continued
TEP
(41b/gal FC)
A No
A No .
A No
TGAI
TGAI A,B No
TGAI A,B No

Must Additional
Data be
Submitted?

Reserved/7
Reserved/7
Reserved/7

Yes/8
Reserved/9

Time Frame
for
Submission





15 Months


- Aquatic Invertebrate
Life-Cycle
- Freshwater
-Estuarine
TGAI A,B No
TGAI A,B No
Yes/8
Reserved/9
15 Months

                                                                                       ON

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                                                      TABLE A
                                  GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
     Test         Use        Does EPA     Bibliographic
     Substance    Pattern    Have Data?   Citation
                                            Must Additional
                                            Data be
                                            Submitted?
                                                    Time Frame
                                                       for
                                                    Submission
72-5 - Fish - Life-Cycle
     TGAI
A,B
No
Reserved/10
72-6 - Aquatic Orqanism
         Accumulation

72-7 - Simulated or Actual
          Field Testinq
          - Aquatic Orqanisms
TGAI, PAI OR
 Deqradation
     TEP
A,B
No
           No
Yes
                                 Yes/11
12 Months
                   15 Months
                                                                                                                         ON

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                                                      TABLE A
                                  GENERIC DATA REQUIREMENTS FOR FENBLTTATIN-OXIDE

§158.145 Wildlife and Aquatic Organisms - Continued

I/  These data are required in order to support the manufacturing use product.
2/  Acute toxicity data indicate that this study is not required.
3/  Because the use directions for this product indicate the need for repeat applications, these data are required.
4/  This requirement is reserved pending receipt for avian reproduction data and additional environmental fate data.
5/  This data requirement is required to support the citrus use. >'
6/  This data requirement is required to support the citrus use.  (Citrus is grown in coastal counties in excess of
    300,000 acres).      <                                        '
7/  Reserved pending the outcome of acute studies on the tehcnica^l material and monitoring data.
8/  This data requirement is required to support the orchard uses.
9/  This requirement is reserved pending the outcome of the chronic studies on freshwater organisms, and on acute
    estuarine organism testing on the technical and the monitoring data.
10/ This requirement is reserved pending the outcome of required ;chronic studies on freshwater and estuarine organisms
    and monitoring data.
ll/ Aquatic residue monitoring studies on fenbutatin-oxide and its major metabolities are required to determine
    exposure levels (acute and chronic) in Florida citrus groves 'and adjacent waters.   Monitorinq of these sites
    is necessary due to the demonstrated aquatic toxicity and persistnace of fenbutatin-oxide.   Based on use
    information, pesticide history and topoqraphy, you must develop an acceptable protocol to sample a representative
    number of citrus use'sites (at least 5).  A protocol must bessubmitted within 3 months of receipt of this
    guidance document.  Monitoring efforts should focus on citrus production sites with a history of fenbutatin-oxide
    use and having extensive adjacent water bodies and canals (freshwater and estuarine).   Residue monitoring
    studies must incorporate the following design characteristics:

      A.  Sampling shall include grove soil and  adjacent waters:'  water column, sediment, benthic invertebrates
          and endemic fish (particularly bottom feeders).        -.'
      B.  Analytical methodology used to measure residuses must be described.
      C.  Sampling stations must be described on U.S.G.S. topographicbathymetric 7.5 minute series maps.
      D.  Soil and sediment characteristics of the sites being monitored must be specified.
      E.  Samples should be taken before, during and following applications of the pesticide and should include control
          sites.                                                 '
      F.  Sampling should be done at regular intervals for a long enough period of time to account for such things as
          seasonal and use variations.                           •

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                                                          TABLE A
                                      GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.150 Plant Protection

121-1 - TARGET AREA
         PHYTOTOXICITY.
>JQNTARGET AREA PHYTOTOXICITY

         TIER I

122-1 - Seed Germination/
        Seedling Emergence

122-1 - Vegetative Vigor

122-2 - Aquatic Plant Growth

         TIER II

L23-1 - Seed Germination/
        Seedling Emergence

123-1 - Vegetative Vigor

123-2 - Aquatic Plant Growth

         TIER III     'I

124-1 - Terrestrial Field

L24-2 - Aquatic Field
 EP
TGAI


TGAI

TGAI



TGAI


TGAI

TGAI



TEP

TEP
V:
V


V

V



V


V

V



V

V
ON
un
I/  These data are not required in accordance with §158.150.

-------
                                                          TABLE A
                                      GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
§158.155 Nontarget Insect'
NONTARGET INSECT TESTING -
POLLINATORS:
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation

Must Additional
Data be
Submitted?

Time Frame
for
Submission

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  ,

NONTARGET INSECT TESTING -
AQUATIC INSECTS;

142-1 - Acute toxicity to
         aquatic insects

142-1 - Aquatic insect
         life-cycle study

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

143-1 - NONTARGET INSECT
thru    TESTING - PREDATORS
143-3   AND PARASITES;
   TGAI         A,B

   TEP         A,B



 (Reserved)I/


   TEP         A,B
Yes

Yes
00036935

00088398
No

No
No
                    No/2
                                                                ON
(Reserved)3/


(Reserved)3/


(Reserved)3/



(Reserved)3/

-------
                                                          TABLE A
                                      GENERIC DATA REQUIREMENTS FOR FENBuTATIN-OXIDB
Data Requirement
i •
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.155 Nontarqet Insect   •


I/  Reserved pending development of methodology.

2/  As data from the acute and residual test indicate low toxicity, no further testing is required.

3/  Reserved pending Agency decision as to whether the data requirement should be established.
                                                                                                                           ON

-------
                                                      TABLE B
              PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENBUTATIN-OXIDE
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
    V
Bibliographic
Citation
Must Additional  Time Frame
Data be             Cor  '
Submitted?       Submission
§158.120 Product Chemistry

Product Identity;

61-1 - Product Identity and           MP
        Disclosure of
        Ingredients

61-2 - Description of Beginning       MP
        Materials and !
        Manufacturing Process

61-3 - Discussion of Formation        MP
        of Impurities

Analysis and Certification of Product
Ingredients

62-1 - Preliminary Analysis           MP

62-2 - Certification of Limits        MP

62-3 - Analytical Methods to Verify   MP
        Certified Limit

Physical and Chemical Characteristics

63-2 - Color                    .      MP

63-3 - Physical State <                MP

63-4 - Odor           -                MP
             All
             All
             All
             All

             All

             All
             All

             All

             All
           No
           No
           No
           No

           No

           No
           No

           No

           No
                                 Yes 2/
                                 Yes 2/
                                 Yes 2/
                                 Yes 2/

                                 Yes 2/

                                 Yes 2/
                                 Yes 2/

                                 Yes 2/

                                 Yes 2/
                                         6 Months
                                         6 Months
                                                    ON
                                         6 Months   °°
                                        12 Months

                                        12 Months

                                        12 Months
                                          6 Months

                                          6 Months

                                          6 Months

-------
                       :                               TABLE B  '
              PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENBUTATIN-OXIDE
Data Requirement .; Test
; Substance
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued) ,
63-7 - Density, Bulk Density, or
Specific Gravity^
63-12 - pH ';
63-14 - Oxidizing or Reducing
Action
63-15 - Flammability (
63-16 - Explodability '•
63-17 - Storage Stability
63-18 - Viscosity •
63-19 - Miscibility
63-20 - Corrosion Characteristics

MP
MP
MP
MP
MP
MP
MP
MP
MP
Use
Pattern

All
All
All
All
All
All
All
All
All
Does EPA Bibliographic
Have Data? Citation
V
!
No
No
No
No
No
No
No
No
No ;
Must Additional
Data be
Submitted? 2/

Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Time Frame
for
Submission

7 Months
7 Months
7 Months
O\
VO
7 Months
7 Months
16 Months
7 Months
7 Months
7 Months
I/ Although product chemistry data may have been submitted in the past,  the Agency has determined that these data must
   be resubmitted for each manufacturing use product.  New requirements  have been introduced and previously submitted
   data must be updated.  Therefore bibliographic citations for the old  data are not applicable.

2/ Product Specific data are required for the following formulation: EPA REG. NO. 201-367.

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                                                      TABLE B
              PRODUCT 5PECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS  CONTAINING FENBUTATIN-OXIDE
Data Requirement
Test         Use        Does EPA     Bibliographic
Substance    Pattern    Have Data?   Citation
                    Must Additional  Time Frame
                    Data be             for
                    Submitted? I/    Submission
§158.135 Toxicology

ACUTE TESTING

81-1 - Acute Oral Toxicity - Rat       MP       All

81-2 - Acute Dermal Toxicity           MP       All
        - Rabbit

81-3 - Acute Inhalation Toxicity       MP       All
        - Rat         3

81-4 - Primary Eye                     MP       All
        Irritation - Rabbit

81-5 - Primary Dermal                  MP       All
        Irritation - Rabbit
                      i
81-6 - Dermal Sensitization -          MP       All
       Guinea Pig
                        No -

                        Yes


                        No -


                        Yes;


                        Yes


                        Yes
00112990
00112990
00112990
00112990
Yes I/

No


Yes I/


No


No


No
                                         9 Months
                                         9 Months
                                                   O
I/ Product Specific data are required for the following formulation: EPA REG. NO. 201-367.

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                                71

                          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)]

-------
                               72


                            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.I0(h)(2)].

-------
                               73
                          SUMMARY-3

    Item 8A. "HAZARD TO HUMANS-AND D0M€-ST-I-G-ANI.MAL&, -n:W.here-.a^t t
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-- o-JTrce starlet e.d: us,e.^-:.Px&&U-G£^-J&£^i£J--gd*.--~.,v*.: ,
for restricted use may be limited to use by certified applicators
or persons under their direct  supervision  (or  may  be  subject
to other restrictions that may be imposed by regulation).

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

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

     If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application  for reregistration.   During
the Agency's review of your, application., your^prppjos^ed.. class i-	
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.

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                               74

                          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 162.10(h)(l)(iv)

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

      2.  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.
    I tern' 9B.  ' 'M'l SUSE'-STATEMENT'—•"•ft-rr ••p'ro'du-c ts~mus t-be-ar- the «
misuse statement, "It is a violation of  Federal  law to  use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning  of the directions
for use,  directly beneath the heading of  that section.

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                               75

                          SUMMARY-5

    Item rOA.  -REENTRY-'^STATEMENT ---^rf• a'"reenftry^rrrtBrva-r «••—-	—
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.

-------
                  SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name .
Company name
and address
Net contents
\
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement :
Front panel
precautionary
statements
Keep Out of Reach
of 'Children
(Child hazard
warning)
Signal 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
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement

Above signal
word
Immediately
below child
hazard
warning
COMMENTS

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

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

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SUMMARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT'
Skull & cross-
bones and word
POISON (in red)
T
i
j
Statement of ^
Practical
Treatment or
First Aid
Referral ;
statement
Side/back panel
precautionary
statements
!<
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
: PREFERRED
Both in close
( proximity to
- signal word
Front panel
for all.

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

-xj
~^J

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

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SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical ' .
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use >
APPLICABILITY
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
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
->x
ex
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units

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                    79
 Chapter I—Environmental Protection Agency
     obtained the data from anothe
     (Identify); applicant copied daf
     , a publication: applicant obt
   spy of the data from EPA).
   \) The applicant shall submit
     ppUcatioii a statement that
     i evaluation of the proper
      and  safety of  the lom\
        product, may not consic
         supportlnc the  appl
        «following data:
        ,e data the  applicant fcs sub-
cacy.
end
data
except
  (1)
mitted tk EPA under
thissectli
  (2)  Other  data
safety of the product's
ents, rather than to the
end-use proHuct; and
  (3) Existing tolerances.
regulations. \exemptl
clearances  Issued unde:
Pood, Drue, and Conn
  (e) If the applicant
Item of data he\ su
section was ten1
pense of) anoth
ly submitted the
predecessor. USD.
ary 1. 1970, to su;
for  registration.
permit, or  amei
use to an
                           &h (b) of

                             to  the
                         (re Ingredl-
                         lety of the
                        Food additive
                         and  other
                        the Federal
                      [cAct.
                        ws that any
                      ted under this
                      y (or at the ex-
                       who original-
                      to EPA (or Its
                   on or after Janu-
                      an application
                   •xperimental  use
                   nt adding a new
                        tlon. or for
reregistration  (tfnlesfc  the applicant
and the original dataXsubmltter have
reached  written  agreement  on the
amount and UK terms )pf payment of
any compensation thatXmay be pay-
able    under     FXFHA    section
a(cXlXDXil)/with regaroX to approval
of the application), the applicant shall
submit to EPA a statement  that he
has furnisaed to each sacn. Identified
                           ipllcant's.
                             Inclurt-
  (1) A nfttfleation of the
intent to Apply for registraUc
tag the imposed product i
  (2) An7 offer to pay the
	    . with regard to the:
of the/ application, to the
       by FIFRA sections
     CX2XDK
     An Identification of the
    >ta to which the offer applies:
     Ay< offer to commence negoX
      to ascertain the amount
      of ronnTpnsi tttm to be paid: a^d
 '(S) The applicant's name,
    telephone number.
                            § 162.10

     If the applicant's product cof
     any active Ingredient other
      that are present solely
       incorporation into the product.
       formulation, of one or/more
            :red  pesticide  ppducts
                                  tr.
                             comply
                           ve ingre-
                         'shall eon-
                          t for pur-
of
d
other
purchased  from  another
then theXappllcant shall
with I iete-3 as to such
dient.  andVhe appllcatloi
tain an acknowledgment
poses of
application re)
Ing registratiot
  section
les on (i
 .should
                        tcXIXD) the
                         any result-
                         regarded
                 the/Administrator's
                 le/ollowing data:
                      or specifically
                    t in support of
                      of data in the
if it were based
consideration of)
 (1) All data su
cited by  the
the registration;
 (2) Each oth<
Agency's files wj
 <1) Concerns me properties or effects
of any such active Ingredient: and
 (U) Is one/of  the typesNof data that
EPA would/equire to be submitted for
scientific seview by EPA lf\Lhe appli-
cant sourfht the  initial
under  BTFRA  Section 3(ctf6)  of  a
       'with composition andVintend-
ed use/ identical to those proposed for
the  applicant's product, undek the
     requirements  in  effect  on\the
     EPA approves  the applicant's
     it application.

    , I.«. and » of RPRA. u i

(44 FR179M, May 11.11781
lltt.lt  LabtUag nqminmrau.
  (a)  General—(1)  Content*  of  the
label Every  pesticide  products shall
bear a label  containing the informa-
tion specified by the Art and the recu*
lations in this Part. The contents of a
label  must show clearly  aad  promi-
nently the following:
  (i) The name, brand, or trademark
under which the product is sold as pre-
scribed  la paragraph (b)  of this sec-
tion:
  (U)  The name  aad address  of  the
producer, registrant, or  person  for
whom produced as-prescribed m para-
graph (c) of this section:
  (ill) The net  contents as prescribed
ta paragraph (d) of this section:

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                                                                                                                                                      I
11*2.10

  (Iv)  The    product   registration
number as prescribed In paragraph (e)
of IhU McUon;
  (v)  The  producing  establishment
number u prescribed  In paragraph (0
of this section:
  (vl) An Ingredient statement as pre-
scribed In paragraph (g) of this sec-
tion;                 I
  (vll) Warning or precautionary state-
ments as  prescribed In paragraph (h)
of this section;
  (vlll) The directions for use as pre-
scribed In paragraph (I) of this section;
and
  llx> The use  classlflcatlon(s) as pre-
scribed In paragraph (j) of this section.
  <» Prominence and leoibUit*  (I) All
word*, statements, graphic representa-
tions, designs or other Information re-
quired 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
consplcuousneas (as  compared with
other words, statements, 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 custom-
 ary conditions of purchase and use.
   (II) All required label text must:
   (A) Be set In 0-polnt or larger type:
   (B)' Appear  on a 'clear contrasting
 background: and
   (C) Mot be obscured or crowded.
   (1) tanffMocw to oe'iuea. 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 ap-
  plied equally  to both the English and
  other-language versions of the label-
  ing.
    (4) Placement of Label-in General
  The label shall appear on or be secure-
  ly attached to the Immediate contain-
  er of the pesticide;product, for  pur-
  poses of this Section,  and the  mls-
  brandlng  provisions of the Act. "se-
  curely  attached" shall mean that a
  SabeJ can reasonably be expected to
  remain  affixed during the  foreseeable
  rmwuibwui tnd oerlod of use. If the Im-
   Till. 40-frotoctlon of fnvlr.nm.nl

wrapper or outside container through
which the label cannot be clearly read.
the  label must also be securely at-
tached to such outside wrapper or con-
tainer, If It Is a part of the package as
customarily distributed or sold.
  (II) Tttn*  can  and other bulk con-
tainer*— 4A) Trantportallon. While a
pesticide product Is In transit,  the ap-
propriate provisions of 49 CFR Parts
 110-189. concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling. marking and placarding of haz-
 ardous materials and the vehicles car-
 rying them, define the basic  Federal
 requirement*. In addition, when tuty
 regUtered pesticide product Is trans-
 ported In a  tank  car. tank truck or
 other mobile or portable bulk contain-
 er. 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 prod-
 ucts are stored  In bulk  containers.
 whether mobile or stationary, which
 remain In  the custody of the user, a
 copy of UM label of labeling. Including
 all appropriate directions for use. shall
 be securely attached to UM container
 In the immediate vicinity of the dis-
 charge control valve.
   (B) faltt or mitleadino statement*.
 Pursuant to section atqMiXA) of the
 Act. a pesticide or a  device  declared
 subject  to  the   Act  pursuant  to
  1 101.15. to mlsbranded If IU labeling la
  false or misleading In any particular
  Including both pestlddal and non-pee-
  Uddal claims. Examples of statements
  or   representations In  the  labeling
  which constitute  mUbrandlng 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;
    (hr» A false or misleading comparison
   with other pesticides or devices;
    < Claims  an  to  the  Mfcty of the
 protlrldc or IU Ingredient*.  Including
 statement* such as "safe." "nonpolson-
 ou»." "nonlnjurloiiii."  "harmleiw" or
 "nontoilc  to humans  and pet*"  with
 or without auch a qualifying phrase M
 "when uned an directed"; and
  (x> Non-numerical and/or  compara-
 tive statement* on the safely of the
 product. Including but not limited to:
   "Contains  all natural  Ingredi-
 ents";
  (B) "Among  the  leant toxic chemi-
 cals known"
  (C> "Pollution approved"
  («> Final printed labeling. (I) Except
 as provided In paragraph (aX6)(ll) 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 text*  have  been provision-
 ally 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 micro-
 film 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.
    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 addl-
  (c) Name and addr.es* of producer.
 registrant, or person  for  whom pro-
 duced. An unqualified name  and ad-
 dress given on the label shall he con-
 sidered as the name and addres* of the
 producer. If the registrant's name ap-
 pear* on the label and  the reglnlrant I*
 not the producer, or If  the name of the
 pe.raon  for whom  the pesticide  w,a*
 produced appears on the label. II. must
 be  qualified by appropriate  wordlps;
 such an "Packed for *  * V "Dlstrlbut-
 ed by * • V or "Sold by	In nrtow
 that the name Is not thai of  I lie pro-
 ducer.                           /
  (d) Net  toefoftf or mrtimrr o/ con-
 tent*. (1) The net  weight  or measure
 of content shall be exclusive of wrap-
 pers or other material* and Nhall/be
 the average content unlraa explicitly'
 stated a* a minimum quantity.
  (3) If the pentlclde  I* a liquid, the
 net content  statement Khali be:.In
 terms of liquid measure at 48* P 
 and shall be exprensed In conventional
 American units of  fluid ounce*, pint*.
 quart*, and gallons.
  ()) If the peMlclde Is solid or nemlso-
 lid. 'viscous or pressurized, or I* a mix-
 ture of liquid and  solid, the net con-
 tent statement shall  be  In term* |of
 weight   expressed  a*   avoirdupois
 pounds and ounces.               ,;.
  (4) In all cases, net content *hali;'|h*
 stated In terms of the largest suitable
 unit*. I.e., "1 pound 10 ounce*" rattier
 than "ad ounces.-                 .-4
  (B) In addition to the required unit*
 specified,  net content  may  be.  ex-
 pressed In metric unit*.           U
  (6) Variation above  minimum  con-
 tent or around an average Is permlsiil-
 ble only to the extent that It repre-
 sents deviation  unavoidable In good
 manufacturing  practice.   Variation
 below a stated minimum Is not permit-
 ted. In no  case shall the average con-
 tent of the packages In a shipment fall
 below the stated average content.   ,1
  (e> Product reotttrattnn  number.
The registration number assigned <;'to
the pesticide product  at the  time'of
registration shall appear on the label.
preceded by the phrase "EPA Regis-
tratlon No.." or the phrase "EPA Rf«.
No." The registration number shall A*
set In type of a.ttce and style similar.to
other print on that part of the UJjrl
 	«-•-«. i.		  ••     .ft,
CD
CD

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                                                                             13:
| U2.10

allel to It The registration number
and  the  required  Identifying phrase
•hall not appear In such a manner as
to suggest or Imply recommendation
or endorsement' of the product by the
Agency.
   Ingredient statement—<1) Oener-
at The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active Ingredient, the total  per-
centage by weight of all Inert Ingredi-
ents; and  If the pesticide contains ar-
 senic  In any form, a statement of the
 percentages of total and  water-soluble
 arsenic  calculated  as element*! ar-
 senic. The active Ingredients must be
 designated by the term "active Ingredi-
 ents" and the Inert Ingredients by the
 term  "Inert Ingredients." or the singu-
 lar forms of  these terms when appro-
 priate.  Both  terms  shall be In the
 same type she. be aligned to the same
 margin and be equally prominent. The
 statement "Inert Ingredients, none" Is
 not required for pesticides which con-
 tain  100 percent active Ingredients.
 Unless the  Ingredient statement Is a
 complete analysts of the pesticide, the
  term  "analysis" shall; not be used as a
  heading for the Ingredient statement.
   (3)  Potitlon o/ ingredient statement.
 .(I) The  Ingredient statement Is  nor-
  mally required on the front panel  of
  the label. If there Is an outside con-
  tainer 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 stse 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.
                                        Till* 40—rrotocHon of IirvV
  (II) The text of the Ingredient state-
ment 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.
  (1) Name* to be m*ed In ingredient
statement The name used for each In-
gredient   shall   be   the  accepted
common  name.  If there  Is one. fol-
lowed  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 propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator  under  the
authority of Section M  Deterioration. Pesticides -which
 change  In chemical composition sig-
 nificantly must meet the following la-
  beling requirements:
   (I) In cases where  It Is determined
  that a  pesticide formulation  changes
  chemical  composition  significantly.
  the product must bear  the following
  statement In a prominent  position on
  the label:  "Not for sale or use  after
  Idatel."
    (II) The product must meet  all  label
  claims up to the expiration time  Indi-
  cated on the label.
    (1) Inert tngredtenU The Adminis-
  trator may  require the name of any
                                            Qiwpter I—Envltonmenlal frefection Agency
                                                      (continued)

                                                                 9 141.10
Inert IngredlenUs) to be tinted In the
Ingredient statement If be determines
that  such Ingredlentls)  may  pose a
hazard to man or the environment.
  (It)  Warning*  and precautionary
itatementt.  Required  warnings  and
precautionary statements concerning
the  general  areas  of  lexicological
hazard  Including hazard  to children.
environmental hazard, and physical or
chemical hawd fall Into two groups;
thoae required on the front panel of
the  labeling and those  which  may
appear elsewhere, Specific require-
ments concerning content, placement.
type  sbie. and prominence are  given
below.
  (I)  Regal ml front panel statement*.
With  the  exception  of  I he  child
hazard warning Mulrmrnt. Hie le«t re-
quired on the front panel of the label
Is determined by the Ton kit y Otfto
ry of the pesticide. The category I* un-
signed on the  ban)*  of  the  hlghcnl.
hazard shown by any of the Indicator*
In the table below:
     lO.
  (I) Human  hatard itgnal word—  Utr of ilonal inonf». Use of  any
•lunal worri(n) aaxoclfttcd with a higher
Toxlclty Category  I"  not permitted
except when the Agency determine*
that such labeling Is necetvwry to pre-
vent unreasonable adverse effect* on
man or the environment. In no  cane
shall more  than one  human h'arjird
signal word appear on the front panel
of a label.
  (II) Child Aosanf vamlng. Rvery pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach  of children."  Only  In own
where  the likelihood of contact,with
children during  distribution. market-
Ing, 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 me on Infants
or small children, may the Administra-
tor waive this requirement.
  (Ill)  Statement o/ practical treat-
ment—
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                                                                       134
I U1.10

cal  treatment to tome reference such
M "See iUUment of practical treat-
ment on back panel" appear* on the
front panel near the word "Poison"
and the skull and croabone*.
  (B) Other forfeit* categories. The
statement of practical treatment to not
required on the front panel except M
described In paragraph (hMlMlllMA) of
thto section. The applicant may. how-
ever. Include such a front panel state-
ment at hto option'/ Statements  of
practical treatment are. however, re-
quired  elsewhere  on  the  label  In
accord with paragraph (hX» of thto
section  If they do not appear on the
front panel.
  (Iv) Placement and prominence All
the require front panel warning state-
ments  shall be grouped together on
the label, and shall appear with suffi-
cient  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 slse require-
ments  for  the  front panel  warning
statements on various' stoes of labels:
  TIM* 40—frotecHon of Invfre-mnanf
    ttot*—
    WtotS.
    Itto]
                                 •0
                                 If
  (» Otter required warning* and pre-
cautionary statement*. The warnings
and  precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary   Statements"   and
under  appropriate  subheadings  of
"Hazard to Humans and Domestic Ani-
mals." "Environmental  Hazard" and
"Physical or Chemical Hazard."
  (I) Jfosard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animal*, precau-
tionary statements are required Indi-
cating the  particular  hazard,  the
routeU) of exposure and the precau-
tions to be  taken to avoid accident.
Injury or damage. The precautionary
paragraph shall be Immediately pre-
ceded by the appropriate hazard signal
word.
  (B) The following (able deplete typi-
cal precautionary  statements. These
statements must be modified o» ex-
panded to reflect specific hazards.
          •**! P* Ml •* to •)•*, •• tfto. •
               «• Mil. O* MI UM»» MI
              •Ml. O* Ml Ml to M*. •»
         IN*
               •M to* Ml «••»«• I* Ml
           0* Ml Ml to OM. •» M\ •> «•
             I |M»t»> • toM MM •* <
  «U) s7nvlronm«nlal[nasard<. Where a
 (hazard exists to nonj target organisms
 including humans and domestic  an9-
 r-MOs. precautionary statements are re-
 quired  stetlng  IhS  nature of  the
Injury  or damage. Examples of the
hazard statements and the  <^lreum-
stancea under which they are required
follow:
  (A) If a pesticide Intended for oui-
 Chapter I—Environmental PreJectlan Agency

 100 or less, the statement "Thto Pesti-
 cide to Toxic to Wildlife" to required.
  (B) If a pesticide Intended for out-
 door use contains an active Ingredient
 with a fUh acute LC» of I ppm or lens.
 the statement "Thto Pesticide to Toxic
 to FUh" to required.
  (C) If a pesticide Intended for) out-
 door use contains an active Ingredient
 with an avi*n acute oral LD- of  100
 mg/kg or less, or  a subactile dietary
 LCM of 600 ppm or lew. the statement
 "Thto Pesticide to Toxic to WlMllfe" to
 required.
  (D) If either accident htotory or field
studies  demonstrate that use of the
pesticide may  result In fatality  to
bird*, flnh or mammals, the statement
                                                                                              (contlnued)

                                                                                                          9 147.10

                                                                               "Thto pesticide Is extremely toxic to
                                                                               wildlife (fish)" to required.
                                                                                (R) For uses Involving foliar applica-
                                                                               tion to agricultural  crops, forests, or
                                                                               shade trees, or for mosquito" abate-
                                                                               ment treatments,  pesticides toxic to
                                                                               pollinating Inserts mast bear appropri-
                                                                               ate label cautions.                '
                                                                                i*M	I 	      _      ni>«n Adequacy am! cfar-
                                         tfir of directions.  Directions for use
                                         must' be stated In terms which >:an be
                                         easily  read and understood by  the
                                         average person likely to use or to su-
                                         pervise 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.
                                          HI) Placement oj directions for «*e.
                                        Directions may appear on any portion
                                        of the label provided that they are
                                        conspicuous enough to be easily read
                                        b> the vtser of  the pestlcflie product.
                                        Directions  for  use may  appear  on
                                        printed or  gr»nhte m«ll»r *>M-K •-
                                      (A) If required by the Agency, such
                                    printed or graphic matter to securely
                                    attached to each package of the pesti-
                                    cide,  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 "Ser.Di-
                                    rections In  the enclosed circular:" and
                                      (C)  The  Administrator determlnr*
                                    that It to not necessary for such direr
                                    tlons to appear on the label.        ;•
                                      (III) exception*  to  reoutwnrn/ for
                                    direction for tue-
-------
1IWL10

  (J) The label clearly show* that the
product  to Intended  for use  only In
manufacturing pioctssts and specifies
the typed) of products Involved.
  (J)  Adequate Information such aa
technical data sheets or bulletins, to
available to  the  trade specifying the
type  of  product  Involved and  IU
proper use In manufacturing process-
es;
  (J» The product will not come  Into
the hands of the  general public except
after Incorporation Into finished prod-
ucts: and
  (4)  The Administrator  determines
that such directions are  not necessary
to  prevent unreasonable  advene ef-
fects on man or the environment.
   Detailed directions for use may
be omitted from  the labeling of pesti-
cide products for which sale to limited
to physicians, veterinarians, or drug-
gists, provided that:
  (1) The label clearly states that the
product to for use only  by physicians
or veterinarians?
  (*> The Administrator determines
that such directions are not necessary
to  prevent  unreasonable  adverse ef-
fects on man or  the environment; and
  (J) The product to also a drug and
regulated under  the provisions of the
Federal Food. Drug and Cosmetic Act.
  (C) Detailed direction* tor uae may
be omitted from the labeling of  pesti-
cide products which are Intended for
use only by formutators In preparing
pesticides for sale to the public, pro-
vided that:
  <1>  Thar* to   Information  readily
available to the tormulators on the
composition, toxldty. methods of use.
 applicable restrictions or limitations.
 and effectiveness of the  product for
 pesticide purposes!
  (1) The label clearly states that the
 product to Intended for  use only  In
 manufacturing,  formulating,  mixing.
 or repacking for use as a pesticide and
 specifies the typets) of pesticide prod-
 ucts Involved;
   < OMiteftb o/ INrecMoiU for I/ce.
The directions for use shall Include
the following, under the headings "Di-
rections for Use**:
  (I) The statement of use classifica-
tion as prescribed In IM.IMJ) Immedi-
ately under  the heading "Directions
for Use."
  Oil Immediately below  the  state-
ment of use classification,  the  state-
ment -It to a violation of Federal law
to use thto product bi a manner Incon-
sistent with IU labeling."
  4III> The stleu) of application,  as for
example the crops, animate, areas, or
objects to be treated.
  (Iv)  The  target  pesUs)  associated
with each site.
   of this nee-
  lion. Any pesticide product for Which
  •omi! uses are classified for general use
  and others for restricted use shall be
  separately labeled according to the la-
  beling standards set forth In thto sub-
  section, and shall be marketed aa sepa-
  rate product* with different registra-
  tion numbers, one bearing  directions
  only for general useXs) and thr  other
  bearing directions for restricted usets)
  except that. If a product has both re-
  stricted u*e<*> and general tiseU). both
  of these tun may appear on a product
  labeled for restricted use. Such  prod-
  ucts shall be subject to the provisions
  or i laa.KxjMai.
   (I) General Vte CliutVtcmUom. Pesti-
  cide products bearing  directions  for
  ui«s)  classified general shall be la-
  beled with the exact words "General
•  Classification" Immediately below the
  heading "Directions for Use." And ref-
  erence  to  the  general classification
  that suggests or Implies that the gen-
  eral utility of the pesticide extends
  beyond those  purposes and  uses con-
  tained In the Directions for Use will be
 considered a false or misleading state-
 ment under the statutory definitions
 of mlsbrandlng.
   (2)  Reitrtcted  Ute  CIoMl/lcafloit.
 Pesticide  producU  bearing  direction
 for  iMrts)  classified restricted  shall
 bear statemenU of restricted use clas-
 sification on  the front panel as de-
 scribed below:
    Directly below thto statement on
 the front panel, a summary statement
 of the terms of restriction Imposed as
 a  precondition to registration shall
 appear. If use to restricted In certified
 applicators, the following statement Is
 required: "For retail sale  to and  use
 only by Certified  Applicators or per
 sons under their direct supervision and
 only for those uses covered by the Cer-
 tified  Applicator's cert If leal Ion."  If.
 however, other regulatory  restrictions
 are Imposed,  the Administrator will
 define the appropriate wording for  the
 terms of restriction by regulation.
   (k> Advertising. IReservedl

 HO FR ISMS. July ». int: «s m  sni*.
 AIM. I. in>: «e FR  Mmi. Aw. 71. ins. »
 amended at «> FR 57M. Feb. S. irtSI

 ll«S.tt  Criteria to JHmnUalUfM •* i
    reaMNtaMe adverse efferU
    of  the Act. /notice of
 Intent to cVutcel registration pursuant
 to section  wbXI) of the  Art.  or a
 notice of Intuit to hold'a  hearing to
 determine  wnether  Ufe remlstrallon
 should be cancelled or denied, as ap-
 propriate, shall \>e tabued, upon a de-
 termination by tHtXdmlnlslrator that
 the pesticide meeOtor exceeds any-of
 the criteria for rJkkyel forth In para-
 graph (aX3> of Into station.  Upon such
 determination/  the\ Administrator
 shall Issue notice by cKrtlfled mall to
 the appllcan/or regtstraWt, as the case
 may be. staling that IheYPPIIcant or
 registrant/ has the  opportunity  to
 submit ovMenee In rebultaJ of such
 presuminlon In accordance win para-
 graph lmX4) of thto section. Tste appli-
cant w registrant shall have forty-five
(45>>Aays frotn the dale such notice b
     to submit evidence In rebulVal  of
    presumption:  provided,  however.
 rfiat for good cause shown the Adnlfn-
 strator may grant an additional sis
OO

-------
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                                      PRODUCT
                                       NAME
                                 ACIIWI
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                                                     100110%
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                                KEEP OUT OF REACH OF CHILDREN
                                     CAUTION
                                     suiiMiin or
                                                   mi ini
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-------
 rniCAUIOWAWV 8f AICMINIS


   HAJAflOJ IO HUMANS


   II OOMfSIC

      DANCUM
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   tww cnoNS row i»c

I • • »»i.i « r**rtf to* to
•»• »»»tm« M •
   "I CMIftV StATtMtNT
   STORAGE AND

     DISPOSAL
      RESTRICTED USE

          PESTICIDE
for rtl|H til* I* n>4 «M »«lr kr CtMlfltd Oppllcileri
•r |>«rii«i nnd«r t»>tlr 4lr«tl'luptr*liU« *«d oolf f*r
^ei« ftti c«f»rt< by Iht CtrllfUd Appllcilort ttrllfl-
citUn. .
       PRODUCT
           NAME
    ACTWf i

    NCIH WONflXNIS 	   »


    TJOTAI                IOOOO*
    1MB rMOOUCT CONTAMS  LM Of  MM OAUON


   KEEP OUT OF REACH OF CHILDREN


      DANGER —POISON
       SIAtCUINI Of PMACICAi. 1RCATUINT
                        r
                        r

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                        r i
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                                  ApOmOHAt MttCMITDNAIIv •TAIEMtNIS
                      5)f StAMl)MUENt NO =

                         •A nr<)l9tflAtON NQ
                                                               CNO**
                                                                                             oo
                                                                                             ui

-------
                             86
                           PHYS/CHEM-l

                    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.

All Other Pressurized
Containers
II.  Non-Pressurized Containers

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

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

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

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

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

                              Flammable.  Keep away from
                              heat and open flame.

                              Do not use or store near
                              heat and open flame.

                              None required.

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                                87

                            STOR-l

             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.

-------
                                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 violation of Federal
    Law.  If these wastes cannot be disposed of by use according to
    label instructions,  contact your State Pesticide or Environmental
    Control Agency, or the Hazardous Waste representative at the nearest
    EPA Regional Office  for guidance."

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

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

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

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

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

-------
                               ° 'PEST/DIS-2
        'PESTICIDE ACTIVE INGREDIENTS THAT ARE- ACUTE HAZARDOUS WASTES
I.  PESTICIDES ON THE "E" LIST
        [40 CFR 261.33(e)]
(with RCRA #  and CAS  #
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine  (Avitrol)
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts
   not otherwise specified)
Cyanogen chloride
•Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl]
   phosphorodithioate  (disulfoton)
0,0-Diethyl 0-pyrazinyl
   phosphorothioate    (Zinophos\)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl
   phosphorothioate  (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexachlorohexahydro-exo,exo-
   dimethanonaphthalene (Isodrin)
Hydrocyanic acid
Methomyl
alpha-Naphthylthiourea  (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide
   (OMPA,. schradan)
Parathion
Phenylmercuric acetate  (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
       POOS
       P070
       P004
       POOS
       P006
       POOS
       P010
       P011
       P012
       P021
       P022
       P024
       P030

       P031
       P037
       P039

       P040
107-13-1
116-06-3
309-00-2
107-18-6
1302-45-0
504-24-5
7778-39-4
1303-28-2
1327-53-3
592-01-8
75-15-0
106-47-8
506-77-4
60-57-1
298-04-4

297-97-2
P044
P071
P047
P034
P020
P050
P088
P051
P097
P057
P059
P069
P063
P066
P072
P075
P085
P089
P092
P094
P098
P102
P105
P106
P058
60-51-5
298-00-0
534-52-1
131-89-5
88-85-7
115-29-7
129-67-9
72-20-8
52-85-7
640-19-7
76-48-8
465-73-6
74-90-8
16752-77-5
86-88-41
54-11-5
152-16-9
56-38-2
62-38-4
298-02-2
151-50-8
107-19-7
26628-22-8
143-33-9
62-74-8

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                             90
                                 PEST/DIS-3
Strychnine, and salts.. ..............^ ,.	P108

0,0,0,0-Tetraethyl                     P109
   dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate               Pill
Thallium sulfate                       P115
Thiofanox                              P045
Toxaphene                              P123
Warfarin (>0.3%)                       P001
Zinc phosphide  (>10%)                   P122
57-24-9.	
60-41-3
3689-24-5

107-49-3
7446-18-6
39196-18-4
8001-35-2
81-81-2
1314-84-7
50 ACTIVES
II.  PESTICIDES DERIVED FROM TRI-, TETRA-, AND PENTACHLOROPHENOLS
     [40 CFR 261.31]
2-Chloroethyl 2-(2,4,6-trichloro-      F027
   phenoxy) ethyl ether
Dehydroabietylammonium                 F027
   pentachlorophenoxide
Erbon                                  F027
0-ethyl 0-(2,4,5-trichlorophenyl)
   ethylphosphonothioate               F027
2,2'-Methylenebis                      F027
   (3,4,6-trichlorophenol)
   (Hexachlorophene)
   —Potassium salt of                 F027
   —Sodium salt of                    F027
   —Disodium salt of                  F027

Pentachlorophenol                      F027
   —Potassium salt of                 F027
   —Sodium salt of                    F027
   —Zinc salt of                      F027
   —Zinc salt of N-alkyl              F027
     (Clg-C., g)-1,3-propanediamine
   —Pentacnlorophenyl laurate         F027

Potassium trichlorophenate  (2,4,6)     F027
Potassium trichlorophenate  (2,4,5)     F027
Silvex                                 F027
   —2-Butoxyethyl ester               F027
   —Butoxypolypropoxypropyl ester     F027
   —Butoxypropyl ester                F027
   —Diethanolamine salt               F027
   —Diisopropanolamine salt           F027
   —Dimethylamine salt                F027
   —Dipropylene glycol isobutyl       F027
     ether ester
   —Ethanolamine salt                 F027
   —2-Ethylhexyl ester                F027
   —Isooctyl ester                    F027
5324-22-1

35109-57-0

136-25-4

327-98-0
70-30-4
67923-62-0
3247-34-5
5736-15-2

87-86-5
7778-73-6
131-52-2
2917-32-0
3772-94-9

2591-21-1
35471-43-3
93-72-1
19398-13-1
53404-07-2
25537-26-2
51170-59-3
53404-09-4
55617-85-1
53535-26-5

7374-47-2
53404-76-5
53404-14-1

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                              91
                                 PEST/DIS-4
   —Isopropanplamine_salt	
   —Monohydroxylaluminum salt
   —Polypropoxypropyl  ester
   —Potassium salt
   —Propylene glycol isobutyl
       ether ester
   •—Sodium salt
   —Triethanolamine salt
   —Triethylamine salt
   —Triisopropanolamine salt
   —Tripropylene glycol isobutyl
     ether ester

Sodium 2-(2,4,5-trichlorophenoxy)
   ethyl sulfate

Tetrachlorophenols
   —Alkylamine*amine salt (as in
     fatty acids of coconut oil)
   —Potassium salt
   —Sodium salt

2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenol salt of
   2,6-bis[(dimethylamino)methyl]
   cyclohexanone
2,4,5-Trichlorophenol,  sodium salt
2,4,6-Trichlorophenol,  sodium salt

2,4,5-Trichlorophenoxyacetic acid
   —Alkyl C-12 amine salt
   —Alkyl C-13 amine salt
   —Alkyl C-14 amine salt
   —N,N-diethylethanolamine salt
   —Dimethylamine salt
   —N,N-dimethyllinoleylamine salt
   —N,N-dimethyloleylamine salt
   —N-oleyl-1,3-propylene
     diamine salt
   —Sodium salt
   —Triethanolamine salt
   —Triethylamine salt
   —Alkyl (C3H7 - C7H9) ester
   —Amyl ester
   —Butoxyethoxypropyl ester
   —2-Butoxyethyl ester
   —Butoxypropyl ester
   —Butyl ester
   —Dipropylene glycol isobutyl
     ether ester
   —2-Ethylhexyl ester
   —Isobutyl ester
.F0.27....... 53404-13^0,
F027     69622-82-8
F027     83562-66-7
F027     2818-16-8
F027     53466-84-5

F027     37913-89-6
F027     17369-89-0
F027     53404-74-3
F027     53404-75-4
F027     53535-30-1
F027     3570-61-4
F027     25167-83-3
F027

F027     53535-27-6
F027     25567-55-9
F027      95-95-4
F027      88-06-2
F027      53404-83-4
 F027      136-32-3
 F027      3784-03-0

 F027      93-79-8
 F027      53404-84-5
 F027      53404-85-6
 F027      53535-37-8
 F027      53404-86-7
 F027      6369-97-7
 F027      53404-88-9
 F027      53404-89-0
 F027      53404-87-8

 F027      13560-99-1
 F027      3813-14-7
 F027      2008-46-0
 F027
 F027      120-39-8
 F027      1928-58-1
 F027      2545-59-7
 F027      1928-48-9
 F027      93-79-8
 F027      53535-31-2

 F027      1928-47-8
 F027      4938-72-1

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                              92
                                 PEST/DIS-5
   —Isopropyl ester                   F027     93-78-7
   —Propylene glycol isobutyl         F027     53466-86-7
     ether ester
   —Tripropylene glycol isobutyl      F027     53535-32-3
     ether ester

4-(2,4,5-Trichlorophenoxy)butyric      F027     93-80-1
   acid  [2,4,5-TB]

2-(2,4,5-Trichlorophenoxy)ethyl        F027     69633-04-1
   hydrogen sulfate  [2,4,5-TES]

1,4'/5'-Trichloro-2'-(2/4/5-           F027     69462-14-2
   trichlorophenoxy)
   methanesulfonanilide  [Edolan U]

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                             93
                                 PEST/DIS-6
                  PESTICXDES... THAT- ARE-T.QXI.C •..•
PESTICIDES ON THE "F" LIST fwith
[40 CFR 261.33(f) ]
Acetone
Acrylonitrile*
Amitrole
Benzene*
Bis ( 2 -ethy Ihexyl ) phthalate
Cacodylic acid
Carbon tetrachloride*
Chloral (hydrate)
( chl oroacetaldehyde )
Chlordane, technical*
Chlorobenzene*
4 -Chloro-m-cresol
Chloroform*
o-Chlorophenol
Creosote
Cresylic acid (cresols)*
Cyclohexane
Cyclohexanone
Decachlorooctahydro-1, 3 , 4-metheno-
2H-cyclobuta[c,d]-pentalen-2-one
(Kepone, chlordecone)
1, 2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-2 , 3- (Dichloroallyl diisopropyl-
thiocarbamate) (diallate,Avadex)
o-Dichlorobenzene*
p-Dichlorobenzene*
Dichlorodifluoromethane
(Freon 12\)
3 , 5-Dichloro-N- (1 , l-dimethyl-2-
propynyl) benzamide
(pronamide, Kerb\)
Dichloro diphenyl dichloroethane
(ODD)
Dichloro diphenyl trichloroethane
(DDT)
Dichloroethyl ether
2 , 4-Dichlorophenoxyacetic,
salts and esters (2,4-D)*
1 , 2-Dichloropropane
1,3-Dichloropropene (Telone)
Dimethyl phthalate
Epichlorohydrin
( l-chloro-2 , 3-epoxypropane)
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate
( chlorobenz ilate )
RCRA #.

U002
U009
U011
U019
U028
U136
U211
U034

U036
U037
U039
U044
U048
U051
U052
U056
U057
U142


U066
U069
U062

U070
U072
U075

U192


U060

U061

U025
U240

U083
U084
U102
U041

U112
U038

and CAS #

67-64-1
107-13-1
61-82-5
71-43-2
117-81-7
75-60-5
56-23-5
302-17-0

57-74-9
108-90-7
59-50-7
67-66-3
95-57-8
8021-39-4
1319-77-3
110-82-7
108-94-1
143-50-0
.

96-12-8
84-74-2
2303-16-4

95-50-1
106-46-7
75-71-8

23950-58-5


72-54-8

50-29-3

1191-17-9-
94-75-7

' 8003-19-8
542-75-6
131-11-3
106-89-8

141-78-6
510-15-6

*Proposed for deletion by TCLP proposal

-------
                            94
                                PEST/DIS-7
Ethylene dibromide (EDB)
Ethylene dichloride*
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene*
Hexachlorocyclopentadiene
Hexachloroethane*
Hydrofluoric acid
Isobutyl alcohol*
Lead acetate
Lindane*
Maleic hydrazide
Mercury
Methoxychlor*
Methyl alcohol  (methanol)
Methyl bromide
Methyl chloride
2,2'-Methylenebis
    (3,4,6-trichlorophenol)
    (hexachlorophene)
    [acute waste per 261.31]
Methylene chloride*
Methyl ethyl ketone*
4-Methyl-2-pentanone
    (methyl isobutyl ketone)
Naphthalene
Nitrobenzene*
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene  (PCNB)
Pentachlorophenol*
    [acute waste per 261.31]
Phenol*
Pyridine*
Resorcinol
Safrole
Selenium disulfide
Silvex  [acute waste per 261.31]
1,1,2,2-Tetrachloroethane*
Tetrachloroethylene*
2,3,4,6-Tetrachlorophenol*
    [acute waste per 261.31]
Thiram
Toluene*
1,1,1-Trichloroethane*
    (•methyl chloroform)
Trichloroethylene*
Trichloromonofluoromethane
    (Freon ll\)
2,4,5-Trichlorophenol*
    [acute waste per 261.31]
2,4,6-Trichlorophenol*
    [acute waste per 261.31]
U067
U077
U115
U122
U125
U127
U130
U131
U134
U140
U144
U129
U148
U151
U247
U154
U029
U045
U132
106-93-4
107-06-2
75-21-8
50-00-0
98-01-1
118-74-1
77-47-4
67-72-1
7664-39-3
78-83-1
301-04-2
58-89-9
123-33-1
7439-97-6
72-43-5
67-56-1
74-83-9
74-87-3
70-30-4
U080
U159
U161
U165
U169
U170
U184
U185
U242
U188
U196
U201
U203
U205
U233
U209
U210
U212
U244
U220
U226
U228
U121
U230
U231
75-09-2
78-93-3
108-10-1
91-20-3
98-95-3
100-02-7
76-01-7
82-68-8
87-86-5
108-95-2
110-86-1
108-46-3
94-59-7
7488-56-4
93-72-1
79-34-5
127-18-4

137-26-8
108-88-3
71-55-6
79-01-6
75-69-4
95-95-4
88-06-2

-------
                             95

                          CONT/DIS-l

.....;..,._./.'	 .CONTAINER.. DISPOSAL. INSTRU-CTJQNS,...^^^

    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
 I(bottles, cans, jars)
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash,
 Non-aerosol products  |  Do  not  reuse bag.
  (baas)	I	
                   Discard bag in trash.
 I.
 Aerosol products
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 byj
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 wordina)
     Manufacturer may replace this phrase with one indicating
     whether and how fiber drum may be reused.

-------
                           96
                                PEST/DIS-8
2,4,5-Trichlorophenoxyacetic acid     U232      93-76-5
   (2,4,5-T)*
   [acute waste per 261.31]
Warfarin (<0.3%)                      U248      81-81-2
Xylene                                U239      1330-20-7
Zinc phosphide  (<10%)                 U249      1314-84-7
83 ACTIVES

-------
                                    97
                      EPA Index to Pesticide Chemicals

                HEXAKIS(2-METHYL-2-PHENYLPROPYL)DISTANNOXANE

        "                    .-TABLE OF CQNTENTS^::--: •   ^

Site Name                                           	Page
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Almond
Apple
Cherry
Citrus Fruits
Eggplant
Grapes
Papaya
Peach
Pear
Pecan
Plum
Prune
Strawberry
Walnut
TERRESTRIAL NONFOOD CROP
2
2
2
3
3
4
4
5
5
6
6
7
6
6
7
8
8
(Agricultural Crops) 8
  Research Crops [including beans (snap, lima and wax), beets
   (table), corn (field and sweet), cucumbers, peas, peppers,
   spinach,'squash (summer), tomatoes, and weed hosts of
   pathogens]                                                       8
  (Ornamental Plants and Forest Trees)                              8
  Ornamental Plants                                                 8

SIEENHOUSE NONFOOD CROP                                             9
  (Agricultural Crops)                                              9
  Epcot Display Crops (not for consumption)                         9
  Research Crops [including beans (snap, lima and wax), beets
   (table), corn (field and sweet), cucumbers, peas, peppers,
   spinach, squash (summer), tomatoes, and weed hosts of
   pathogens]                                                      10
  (Ornamental Plants and Forest Trees)                             10
  Ornamental Plants                                                10
Issued:  3-10-86               III-104601-i

-------
                                                98
                                 EPA Index to Pesticide Chemicals

C104601                    HEXAKIS(2-METff?L-2-PHENTLPROPYL)DISTANNOXANE*

            TYPE PESTICIDErj'-~Acaricide*^-»>.-^....~.--.., , ^^.-.^. --....,, ,	 .^ _„.

            FORMULATIONS;
            Tech (97%)
            WP   (50%)  (water  soluble package)
            F1C  (4  Ib/gal)

            GENERAL  WARNINGS AND LIMITATIONS;  Do not get into eyes, on skin, or on
            clothing.   Wear suitable eye protection, such as goggles or safety glasses
            with side shields  or their equivalent, when pouring liquid product from
            container or handling wettable powder products.  Avoid handling inner
            water soluble  bag  of wettable powder products as moisture will cause
            breakage.   During  commercial application or other prolonged exposure, use
            goggles  and face mask.  Wear clean protective clothing that covers the
            body well.  Do not graze or feed animals on cover crops grown in treated
            areas.   Avoid  contamination of food, feedstuffs and domestic water sup-
            plies.

            ENVIRONMENTAL  HAZARDS;  This product is toxic to fish.  Keep out of lakes,
            ponds and streams.  Do not contaminate water by cleaning of equipment or
            disposal of wastes.

            USE  DIRECTIONS;  Apply hexakis only by ground equipment.  Hexakis may be
            applied  when honeybees and other beneficials are present.

            REENTRY  STATEMENTS;  Do not apply hexakis in such a manner as to directly
            or through  drift expose workers or other persons.  The area being treated
           must  be  vacated by unprotected persons.  Do not enter treated areas with-
            out  protective clothing until sprays have dried.  California and Texas
nave a j. uay teeuury
Commodity Tolerances
Cattle, fat
Cattle, meat
Cattle , mbyp
Cucumbers
Eggs
Goats, fat
Goats , meat
Goats, mbyp
Hogs, fat
Hogs, meat
Hogs, mbyp
Horses, fat
Horses; meat
Horses, mbyp
Milk, fat
Poultry, fat
Poultry, meat
periou.
(other than those listed in the text):
0.5 ppm
0.5 ppm
0.5 ppm
4.0 ppm
0.1 ppm
0.5 ppm
0.5 ppm
0.5 ppm
0.5 ppm
0.5 ppm
0.5 ppm
0.5 ppm
0.5 ppm
0.5 ppm
0.1 ppm
0.1 ppm
0.1 ppm
           *hexakls (beta,beta-dimethylphenethyl)distannoxane
            Vendex
            Fenbuta tin-oxide

      Issued:  3-10-86               III-104601-1

-------
                                                    99
                                  EPA Index to Pesticide Chemicals

                            HEXAKIS(2-METHYL-2-PHENYLPROPYL)DISTANNOXANE

                            -iQip^Lim^                               		
                            MMMWBMMMH^MM«•^H0^MM^^B                   •    —-•Jii.Cj- ._ .	.Jg|, .^"If t',Tii£ ^ |'f T* • J'CSS
            Poultry, mbyp
            Raspberry
            Sheep,  fat
            Sheep, meat
            Sheep, mbyp
                    0.1 ppm
                   10   ppm (proposed 6/11/86)
                    0.5 ppm
                    0.5 ppm
                    0.5 ppm
'03001AA
Site and Pest


TERRESTRIAL FOOD CROP

  (Agricultural Crops)

  Almond
                                    Dosages and   Tolerance, Use, Limitations
                                    Formulation(s)
ILAVASA
ILAVBAA
ILAVBQA
ILAVBEA
  '  European red mite
  2Pacific spider mite
  2 Pecan leaf scorch
     mite (Pecan spider
     mite/Hickory
     spider mite)
  - Twospotted spider
     mite
0.125-6.25
 lb/100 gal
 [up to 500
 gal /A]
(50Z WP)
 000201-00369
(4 Ib/gal
 F1C)
 000201-00412
  or
 0.5 ppm (almonds)
80   ppm (hulls)
14 day preharvest interval through
1.25 pounds per acre.
Do not apply more than 2 times per
season.

Dilute foliar application.  Apply
when mites first appear and repeat
as necessary to maintain control.
                                                         •pplirnfj-m.  Ap-
                                    0.5-1.25 Ib/A Concentrate
                                    (50Z WP)      ply when mites first appear and re-
                                    (4 Ib/gal     peat as necessary to maintain con-
                                     F1C)         trol.
       Issued:  3-10-86
                          III-104601-2

-------
                                  EPA Index to Pek4iM.de Chemicals

                            HEXAKIS(2-METHYL-2-PHENYLPROPYL)DISTANNOXANE

                '*and-Pest •^^^•»^-ft-«aan-De.8a.geLS.aaa,(|aa^TQlfigance> Use, Limitations
                                    Formulat ion (a )
 /04001AA
Apple
ILAJAKA
ILAVASA
ILAVAYA

IIAVBEA

HAVAZA
  Apple rust mite
  European red mite
  McOaniel spider
   mite
  Twospotted spider
   mite
  Yellow spider mite
   (Carpini spider
   mite)
/05002AA
Cherry
ILAJBEA
ILAVASA
ILAVAYA
  Cherry rust mites
  European red mite
  McDaniel spider
   mite
15 ppm (apples)
75 ppm (dried apple pomace)
14 day preharvest interval through
1.5 pounds per acre.
Do not apply more than 4 times per
season including a prebloom spray;
apply no more than 3 times between
petal fall and harvest.

Dilute foliar application.  Apply
when mites first appear and repeat
as necessary to maintain control.
0.125-0.25
 lb/100 gal
 [up to 600
 gal/A]
(50% WP)
 000201-00369
(4 Ib/gal
 F1C)
 000201-00412
  or
0.5-1.5 Ib/A  Concentrate foliar application.  Ap-
(50X WP)      ply when mites first appear and re-
(4 Ib/gal     peat as necessary to maintain con-
 P1C)         trol.

              6 ppm (cherries, sweet and sour)
              14 day preharvest interval through
              1.5 pounds per acre.
              Do not apply more than 2 times per
              season.

0.125-0.25    Dilute foliar application.  Apply
 lb/100 gal   when mites first appear and repeat
 [up to 600   as necessary to maintain control.
 gal/A]
(SOX WP)
 000201-00369
(4 Ib/gal
 F1C)
 000201-00412
  or
0.75-1.5 Ib/A Concentrate foliar application.  Ap-
(501 WP)      ply when mites first appear and re-
(4 Ib/gal     peat as necessary to maintain con-
 F1C)         trol.
       Issued:  3-10-86
                        III-104601-3

-------
                                                   101
 02000AA
            Site and Pest
 Citrus  Fruits
      EPA Index to Pesticide  Chemicals

HEXAKIS(2-METHYL-2-PHENYLPROPYL)DISTANNOXANE

        Dosages and   Tolerance, Use, Limitations
        Formulation( s)

                      20 ppra (citrus fruits)
                      35 ppm (dried citrus pulp)
                      7 day preharvest interval through 4
                      pounds per acre.
                      Do not apply more than 4 sprays in
                      any 12 month period.
 LAVARA
 LAJBCA
 LAVAKA
 LAVBEA

 LAVAJA
2  Citrus  red mite
   Citrus  rust mite
'-•  Texas citrus mite
   Tvospotted spider
   mite
   Yuma spider mite
 '11001AA
Eggplant
ILAVCJA
ILAVBEA
  Glover's mite
  Twospotted  spider
   mite
        0.125-0.25
         lb/100 gal
         [up to 1,600
         gal/A]
        (50% WP)
         000201-00369
        (4 Ib/gal
         F1C)
         000201-00412
          or
        1.0-2.0 Ib/A
        (50% WP)
        (4 Ib/gal
         F1C)
Dilute foliar application.  Apply
when mites first appear and repeat
as necessary to maintain control.
         1.0-2.0  Ib/A
         (50% WP)
          000201-00369
         (4  Ib/gal
          F1C)
          000201-00412
Concentrate foliar application.  Ap-
ply when mites first appear and re-
peat as necessary to maintain con-
trol.

6 ppm
3 day preharvest interval through 2
pounds per acre.
Do not exceed 6 applications per
season with a total of no more than
6 pounds active ingredient per acre
per year.
Use limited to areas other than CA.

Foliar application.  Apply when
mites appear.  Repeat as necessary
to maintain control.  Thorough
coverage for all leaf surfaces is
required for best control.
In Florida apply when needed or
every 1 to 2 weeks.
       Issued:  3-10-86
                         III-104601-4

-------
            Site-and: Pest
                                  EPA Index to Pesticide Chemicals

                            HEXAKIS(2-METm-2-PHENYLPROPYL)DISTANNOXANE
                      Dosages and.  Tolerance, Use, Limitations
                     " Formula ti-dtt( &
  01014AA
Grapes
 XAVARA
 IAVBAA
 IAVBEA
  European red mite   0.25-0.5 lb/
  Pacific spider mite  100 gal
  Twospotted spider    [up to 250
   mite                gal /A]
                      (50Z WP)
                       000201-00369
                      (4 Ib/gal
                       F1C)
                5 ppm (grapes)
               20 ppm (raisins or raisin waste)
              100 ppm (dried grape pomace)
              28 day preharvest Interval through
              1.25 pounds per acre.
              Do not apply more than 2 times per
              season.

              Dilute foliar application.  Apply
              When mites first-appear and repeat
              as necessary to maintain control but
              not within 21 days.
(06010AA
Papaya
 000201-00412
  or
0.5-1.25 Ib/A Concentrate foliar application.  Ap-
(502 WP)      ply when mites first appear.  Repeat
(4 Ib/gal     as necessary to maintain control but
 F1C)         not within 21 days.

              2 ppm
              7 day preharvest interval through 1
              pound per acre.
              Do not apply more than once per
              month to bearing trees and not more
              than 9 times per season.
              Not registered for use in Califor-
              nia.
ILATABA
IIAVAWA
ILAVARA
ILAVAEA

ILAVAKA
  Broad mite
  Carmine spider mite
  Citrus red mite
  Red and black flat
   mite
  Texas citrus mite
0.125-0.25
 lb/100 gal
 [up to 400
 gal/A]
(50Z WP)
 000201-00369
Dilute foliar application.  Apply
when mites first appear and repeat
as necessary to maintain control.
       Issued:  3-10-86
                        III-104601-5

-------
                                                  103
                                  EPA Index to Pesticide Chemicals

                            HEXAKIS(2-METHYL-2-PHEMYLPROPYL)DISTANNOXANE
'Site  and-.pes.t-
                                    ,Dosages. ajad   Tolerance, Use, Limitations
                                    Formulation^)""=.——
                                                                          ar*K*i**wtx.\
 '05004AA
 '05G05AA
 '05006AA
 ELBGABA
 CLAVARA
 [LAVAYA

 tIAVBAA
 ILAJAIA
 I1AJAJA
ILAVBEA
    Bigbeaked plum mite
    European red mite
    McDaniel spider
     mite
    Pacific spider mite
    Peach silver mite
    Plum rust mite
     (Plum nursery
     mite)
    Twospotted spider
     mite
/04003AA
  Pear
ILAVARA
HAVAYA

ILAJAOA
ILAVBEA
    European red mite
    McDaniel spider
     mite
    Pear rust mite
    Twospotted spider
     mite
              10 ppm (peaches, plums, prunes)
              20 ppm (dried prunes)
              14 day preharvest Interval through
              1 pound per acre.
              Do not apply more than 2 times per
              season.

0.125-0.25    Dilute foliar application.  Apply
 lb/100 gal   when mites first appear and repeat
 [up to 400   as necessary to maintain control.
 gal/A]
(50% WP)
 000201-00369
(4 Ib/gal
 F1C)
 000201-00412
  or
0.5-1.0 lb/A-  Concentrate foliar application.  Ap-
(501 WP)      ply when mites first appear and re-
(4 Ib/gal     peat as necessary to maintain con-
 F1C)         trol.

              15 ppm
              14 day preharvest interval through -
              1.5 pounds per acre.
              Do not apply more than 4 times per
              season Including a prebloom spray;
              apply no more than 3 times between
              petal fall and harvest.
0.125-0.25
 lb/100 gal
 [up to 600
 gal/A]
(50Z WP)
 000201-00369
(4 Ib/gal
 PIC)
 000201-00412
  or
0.5-1.5 Ib/A
(50Z WP)
(4 Ib/gal
 PIC)
Dilute foliar application.  Apply
when mites first appear and repeat
as necessary to maintain control.
                                                  Concentrate foliar application.   Ap-
                                                  ply when nites  first appear  and  re-
                                                  peat as necessary to maintain  con-
                                                  trol.
       Issued:  3-10-86
                           III-104601-6

-------
                                                  104
                                 EPA Index to Pesticide Chemicals

                            HEXAKIS(2-METHYL-2-PHENYLPROPYL)DISTANNOXANE
and 'Pest'""-
 33008AA
Pecan
 LATOQA
'01016AA
Strawberry .
ILAVBEA
  Twospotted spider
   mite
                                    Dosages ^
                                    Formulation(s)
                                                                      „ .„ ______ ..,_     —
                                                      —   ^=====*^SA%e!S)S^^
  Pecan leaf scorch
   mite (Pecan spider
   mite/Hickory
   mite)
                                 0.5 ppm
                                 14 day preharvest interval through
                                 1.25 pounds  per acre.
                                 Do not apply more than  2 times per
                                 season.

                                 Dilute foliar application.

                                 Concentrate  foliar application.


                   Refer to  Pecan leaf scorch mite under Almond for
                   use and limitation information.

                               - See Peach cluster.

                                 See Peach cluster.

                                 10 ppm
                                 1 day preharvest interval through 1
                                 pound per acre.
                                 Do not apply more than  4 times per
                                 season.
                                 Dilute foliar application.   Apply
                                 when  mites  first appear and repeat
                                 as necessary to maintain control.
                                 Adjust spray volume and nozzle
                                 placement to assure good coverage
                                 of top and  underside of leaves.
0.375-0.5
 lb/100 gal
 [150-200
 gal/A]
(50% WP)
 000201-00369
(4 Ib/gal
 F1C)
 000201-00412
  or
0.75-1.0 Ib/A Concentrate foliar application.  Ap-
(50% WP)      ply when mites first appear and re-
(4 Ib/gal     peat as necessary to maintain con-
 F1C)         trol.  Adjust spray volume and noz-
              zle placement to assure good cover-
              age of top and underside of leaves.
       Issued:   3-10-86
                        III-104601-7

-------
  03009AA
            .Site and-Pest..
  Walnut
 1A7ASA
 IAVBAA
 1AVBEA
                      EPA Index to Pesticide Chemicals

                HEXAKIS(2-METHYL-2-PHENYLPROPYL)DISTANNOXANE

                               ^an.'JL	Tolerance, Use, Limitations
                                      ~»T££3r«»-;\ > /%3:S^":V/~^i™^1;'f^''"T*tt^".
    European red mite
    Pacific spider mite
    Twospotted spider
     mite
              0.5 ppm
              14 day preharvest interval through
              1.25 pounds per acre.
              Do not apply more than 2 times per
              season.

              Dilute foliar application.

              Concentrate foliar application.
                                     Refer to  pests under Almond for use and limitation
                                     information.
 /28085DA
ILAAABA
/32000AA
ILAVBNA
ILAVAPA
liAVBEA
TERRESTRIAL NONFOOD CROP

  (Agricultural Crops)

  Research Crops (including beans
   (snap, lima and wax), beets
   (table), corn (field and sweet),
   cucumbers, peas, peppers, spinach,
   squash (summer), tomatoes, and
   weed hosts of pathogens]
    Mites
2.25 g/gal
(50% WP)
 24(C)   CA790076 (renewed 3/9/84)
 For use only at premises of Del
 Monte  Corp.,  Alameda County.  No
 part of treated plants may be used
-for foocUor~feed...  All applicable
 directions,  restrictions and pre-
 cautions on  EPA registered label
 (201-369) are to be followed.

 Foliar application to containerized
 plants using hand held wand.  Spray
 to  runoff.
  (Ornamental Plants and Forest Trees)

  Ornamental Plants
                                      Do not add to oil spray  solutions.
                                      Do not apply more than once  every
                                      28 days.  Apply to foliage of  chry-
                                      santhemums in the prebloom stage  and
                                      to poinsettias in the prebract
                                      stage.

 •it  Oligonychus mites   0.25-0.5 lb/  Dilute foliar application.   Apply
    Spruce spider mite
    Twospotted spider
     mite
 100 gal     ..when mites first appear and repeat
(501 WP)      as needed.
 000201-00369
(4 Ib/gal
 F1C)
 000201-00412
       Issued:  3-10-86
                          III-104601-8

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     Site and Pest
                            106

             EPA Index to Pesticide Chemicals

        HEXAKIS (2-METHYL-2-PHENYLPROPYL )DISTANNOXANE

               Dosages  and    Tolerance, Use, Limitations
               Formulation( s)
     GREENHOUSE NONFOOD CROP
        (Agricultural Crops)

       Epcot Display Crops (not for con-
        sump t
DlSP
ion)
24(C)  FL840002
For use only in "The Land", EPCOT
Center, Lake Buena Visa, Florida.
Crops (including resulting produce)
not listed on the federal label must
be destroyed following harvest and
IN NO CASE SHOULD BE CONSUMED.  All
applicable directions, restrictions
and precautions on the EPA-register-
ed label are to be followed.
         Apple rust mite     0.125-0.5 lb/ Dilute/concentrate foliar applica-
         Bigbeaked plum mite  100 gal      tion.
         Citrus red mite       or
         Citrus rust mite    0.5-2.0 Ib/A
         Cherry rust mites   (4 Ib/gal
         European red mite    F1C)
         Glover's mite    -•--•...
         McDaniel spider
          mite
         Oligonychus mites
         Pacific spider mite
         Peach silver mite
         Pear rust mite
         Pecan leaf scorch
          mite (Pecan spider
          mite/Hickory
          spider mite)
         Plum rust mite
          (Plum nursery
          mite)
         Spruce spider mite
         Texas citrus mite
         Twospotted spider
          mite
         Yellow spider mite
          (Carpini spider
          mite)
         Yuma spider mite
Issued:  3-10-86
                  III-104601-9

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                                                 istlcid
            Site and Pest
                    EPA Index to Pesticide Chemicals

              HEXAKIS ( 2-METHYL-2-PHENTfLPROPYL)DISTANNOXANE

                      Dosages and   Tolerance, Use, Limitations

 '28085DA
Research Crops [including beans
 (snap, lima and wax), beets
 (table), corn (field and sweet),
 cucumbers, peas, peppers, spinach,
 squash (summer), tomatoes, and
 weed hosts of pathogens]
2A(C)  CA790076 (renewed 3/9/84)
                                    Refer to TERRESTRIAL NON-FOOD CROP, (Agricultural
                                    Crops), Research Crop, for pests, use and limita-
                                    tion information.
              (Ornamental Plants and Forest Trees)
/32000AA
Ornamental Plants
ILAVBNA
ILAVAPA
ILAVBEA
  Oligonychus mites
  Spruce spider mite
  Twospotted spider1~
   mite
0.25-0.5 lb/
 100 gal
Do not add oil spray to solutions.
Do not apply more than once every
28 days.  Apply to foliage of chry-
santhemums in the prebloom stage and
to poinsettias in the prebract
stage.

Dilute foliar application.  Apply
when mites first appear and repeat
                                     000201-00369
                                    (4 Ib/gal
                                     F1C)
                                     000201-00412
       Issued:  3-10-86
                        111-104601-10

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                                                  108
                                 EPA Index to Pesticide Chemicals

                           HEXAKIS (2-METHYL-2-PHENtLPROP'!L)DISTANNOXANE

                              r£fe^^

i097.0001   97% technical chemical
              hexakis(2-tnethyl-2-phenylpropyl)distannoxatie (104601)
                000201-00367

»050.0006   501 wettable powder
              hexakis(2-methyl-2-phenylpropyl)distannoxane (10A601)
                000201-00369

1204.0015   4 Ib/gal flovable  concentrate
              hexakis(2-inethyl-2-phenylpropyl)distannoxane (104601)
                000201-00412
            Intrastate Registrations
            None
           Special Local Need  (24(c)) Registrations

           (000201-00369):   CA78013400    CA79007600    CA800n600   PL79001800
                  " " "       'FL83002600 " ' FL84002700-—GA8-30004017,-u.MBlOOOaQO
                             OR78004100    TX83003400

           (000201-00412):  AR83001400    FL83002700    FL84000200   FL84002800
                            GA83000402    PA80003300    TX83003300
      Issued:  3-10-86
III-104601-U

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                                     109
                      EPA Index to Pesticide Chemicals

               HEXAKIS (2-METHYL-2-PHENYLPROPYL)DISTANNOXANE

                          Auxiliary Documentation

000201-00369 - Jacket missing.

000201-00412 - The statement, "Do not use Vendex 4L on the following
citrus:  tangerines, tangelos" appearing on this label was deleted Oct.
17, 1985 in response to a request dated Aug.  12, 1985.  The currently
accepted label 11/27/85 was submitted for approval Sept. 23, 1985, i.e.,
before the agreement to delete the statement  was approved.

24(C) 790076 renewed 3/9/84 does not take into account that this product
is now marketed in water soluble bags.

24(C) PL840002 fails to list sites of application, pests controlled, dos-
ages, and any other use directions.   The only instructions it gives are
to apply to Epcot Display Crops at the dosage rates listed on 000201-
00412.  As such I am indicating the full range of dosages, 0.125-0.5
pounds per 100 gallons water or 0.5-2.0 Ib/A and am listing all the pests
on 000201-00412.  I believe that the registrant should be asked to list
all crops grown at the Epcot Center and applicable pests and dosages.
Issued:  3-10-86               III-104601-a

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                              110

                            BIBGUIDE-1

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

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

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

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

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                          Ill
                         BIBGUIDE-2
 a.  . Author. ..Jtfhe.ne.v.e.r._.tLhe Agency.. j^OLuLd ,cpnf ide.ntly identify
"'""	"one/  the'~A*gerfcy- ha^^-hos^err-tor-straw •-a--p'eTSonia-lr-^a-u-thoT
     When  no  individual was identified, the Agency has
     shown an  identifiable laboratory or  testing facility
     as  author.   As a last resort,  the Agency has shown
     the first submitter as author.

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

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

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

     (1) ,  Submission Date.  The date of the earliest known
          submission appears ~rmmex3d-ate-]ry-"fo-H.owing-:ther word--"3
          "received."

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

     (3)   Submitter.  The third element is the submitter,
          following the phrase "submitted by."  When
          authorship is defaulted to the submitter, this
          element is omitted.

     (4)   Volume Identification (Accession Numbers).  The
          final  element in the trailing parentheses
          identifies the EPA accession number of the volume
          in which the original submission of  the study
          appears.   The six-digit accession number follows
          the  symbol "CDL," standing for "Company Data
          Library."  This accession number is  in turn	 .
          followed by an alphabetic suffix which shows  the
          relative position of the  study within the volume.
          For  example, within accession number  123456,  the
          first  study would be 123456-A;  the second, 123456-
          B; the 26th, 123456-Z; and the 27th,  123456-AA.

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                                     112
                  ''''  OFFICE" OP^ESrrcIBE^PRQQR^^
                   REGISTRATION STANDARD BIBLIOGRAPHY
      Citations Considered to be Part of the Data Base Supporting
                Registrations Under the Vendex Standard
  MRID            CITATION

00026038 Nugent, K.D.; Zwick, B.; Matsuyama, H.; et al. (1978) Residue Data
            Developed from the Use of Vendex Miticide on Cherries.
            (Unpublished study received Dec 11, 1979 under 201-369; pre-
            pared in cooperation with Univ. of Oregon, Mid-Columbia Exper-
            iment Station and others, submitted by Shell Chemical Co.,
            Washington, D.C.; CDL:099140-1)

00030349 Nugent, K.D.; Hewitt, A.J.; Simkover, H.G. (1979) Residue Data
            Developed from the Use of Vendex Miticide (4 Lb/Gallon Liq-
            uid) on Apples, Pears and Citrus.  (Unpublished study received
            Jan 10, 1980 under 201-412; prepared in cooperation with Mich-
            igan State Univ., Dept. of Entomology and others, submitted by
            Shell Chemical Co., Washington, D.C.; CDL:241616-1)

00036935 Atkins, E.L.; Greywcod, E.A.; Macdonald, R.L. (1975) Toxicity of
            Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
            ratory Studies.  By University of California, Dept. of Entomolo-
       ""    gy.'	?:' UC;"Cc<^rativejefixtieraden^^                         •• -.-.
            study.)

00037581 Granville, G.C.; Simpson, B.J.; Doak, S.M.; et al. (1973) Toxicity
            Studies on the Pesticide SD 14114: An 18 Month Feeding Study
            in Mice: TLGR.0036.73.  (Unpublished study received on unknown
            date under 4F1492; prepared by Shell Research, Ltd., submitted
            by Shell Chemical Co., Washington, D.C.; CDL:093941-H)

00037582 Simpson, B.J.; Granville, G.; Doak, S.M.; et al. (1973) Toxicity
            Studies on the Pesticide SD 14114: Two Year Oral Experiment in
            Rats: TLGR.0034.73.  (Unpublished study received on unknown
            date under 4F1492; prepared by Shell Research, Ltd., submitted
            by Shell Chemical Co., Washington, D.C.; CDL:093941-I)

00037583 Granville, G.C.; Dix, K.M.; Stevenson, D.E.  (1973) Toxicity Stud-
            ies on the Pesticide SD 14114: Two Year Oral Toxicity Test in
            Dogs: TLGR.0035.73.  (Unpublished study received on unknown
            date under 4F1492; prepared by Shell Research, Ltd., submitted
         '  by Shell Chemical Co., Washington, D.C.; CDL:093941-J)

00045869 University of Hawaii (1979) The Results .of. Tests on the Amount of
            Vendex and It's Metabolite Residues Remaining in or on Papaya
            Including a Description of the Analytical Method Used.  Summary
            of study 099547-B.  (Compilation; unpublished study received
            Aug 15, 1980 under OE2397; submitted by Interregional Research
            Project No. 4, New Brunswick, N.J.;  CDL:099547-A)

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                                   113
                      OFFICE OF PESTICIDE PROGRAMS
                   REGISTRATION STANDARD BIBLIOGRAPHY
      Citations Considered to be Part of the Data Base Supporting
                Registrations Under the Vendex Standard-•
  MRJD            CITATION

00045870 University of Hawaii (1976) Analytical Procedure for Vendex (R):  in
            Papaya.  Undated method.  (Unpublished study received Aug 15,
            1980 under OE2397; prepared by Agricultural Biochemistry Dept.,
            Pesticide Laboratory, submitted by Interregional Research Proj-
            ect No. 4, New Brunswick, N.J.; CDL:099547-B)

00069881 Shell Chemical Company (1975) Summary of Information Regarding Res-
            idues of Vendex on Strawberries.  (Compilation; unpublished
            study, including TIR-24-140-74, TIR-24-706-73, TIR-24-707-73,
            ..., received Apr 13, 1976 under 201-369; CDL:097032-B)

00070506 Potter, J.C. (1980) 1979—Residue Data for Vendex Miticide and
            Its Organotin Metabolites SD 31723 and SD 33608, in Filberts
            following Three Applications of Vendex to Filbert Trees, an
            Oregon Study: RIR-24-273-79.  (Unpublished study received Feb
            17, 1981 under 201-412; submitted by Shell Chemical Co., Wash-
            ington, .D..C..;..CDL:244429-AL		...._	

00071183 Shell Chemical Company (1979) Residue Data Developed from the Use
            of Vendex Miticide on Strawberries.  (Compilation; unpub-
            lished study received Sep 3, 1980 under 201-369; CDL:099580-A)

00071228 Lee, P.W. (1979) Determination of the Mobility of SD 9129, SD 6120,
            SD 14114, SD 12011, SD 15418, SD 45328 and Selected Reference
            Pesticides by Soil Thin-layer Chromatography: TIR-22-125-79.
            (Unpublished study received Jan 22, 1981 under 201-157; submit-
            ted by Shell Chemical Co., Washington, D.C.; CDL:099891-M)

00072693 Dix, K.M.; Cassidy, S.L.; Hend, R.W.; et al. (1981) Teratology
            Study in Rats Given SD 14114 by Gavage: Group Research Report
            TLGR.80.145.  (Unpublished study received Apr 27, 1981 under
            201-369; prepared by Shell, Ltd., England, submitted by Shell
            Chemical Co., Washington, D.C.; CDL:244935-A)

00077245 Shell Chemical Company (1981) Residue Data Developed from the Use
         ,.  of Vendex Miticide on Grapes and Grape Products.  (Com-
            pilation; unpublished study received Jun 25,  1981 under 201-369;
            CDL:245469-A)

00079319 Dix, K.M.; Cassidy, S.L.; Vilkauls, J.; et al.  (1981) Teratology
            Study in New Zealand White Rabbits given SD  14114: SBGR.18055
            (Unpublished study received July 23, 1981 under 201-369;
            prepared by Shell Res. Ltd. England; submitted by Shell Chem-
            ical Co., Washington, D.C.; CDL 245605-A).

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                                     114
                       OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY""-«.—«•»•---.
       Citations Considered to be Part of the Data Base Supporting
                 Registrations Under the Vendex Standard
   MRID            CITATION

 00088398 Johansen, C.; Eves, J. (1970)  Bee Research Investigations,  1970.
             (Unpublished study received Feb 1,  1973 under unknown admin.
             no.; prepared by Washington State Univ., submitted by Shell
             Chemical Co., Washington,  D.C.; CDL:222266-D)

 00093721 Shell Oil Company (1980)  Summary of Information Regarding Residues
             of Vendex Miticide on Apples, Pears,  and Citrus.   Includes
             method MMS-R-494-2 dated Dec 1979.   (Compilation; unpublished
             study received Jan 19, 1982 under 2F2631; CDL:070602-A)

 00105161 Reinsfelder, R.; Simkover,  H.; Collins,  R.; et al.  (1982) The Re-
             sults of Tests on the Amount of Residues Remaining, Including a
             Description of the Analytical Methods Used: Vendex.  (-Unpub-
             lished study received Jun 24, 1982 under 201-369; prepared in
             cooperation with Louisiana State Univ., Pecan Station and Henry
             Agri-Scientific, submitted by Shell Chemical Co., Washington,
             DC; CDL:070967-A)

*b"6l05203' Shell Chemical" Co." (1982) * Summary of J4sV6nde-x"-Miticide-i'Residue-Data—
             Grapes (4L).  (Conpilation; unpublished study received Jun 17,
             1982 under 201-412; CDL:247721-A)

 00105204 Shell Chemical Co. (1982) Summary of Corridor Residue Data for
             Apples, Pears, and Citrus Which Had Received Applications of
             Vendex 50WP or 4L Miticide.  (Compilation; unpublished study
             received Jun 17, 1982 under 201-412;  CDL:247722-A)

 00109280 Shell Oil Co. (1982) Summary:  Evendex 4L Miticide.   (Compilation;
             unpublished study received Jul 20,  1982 under 201-412; CDL:
             247906-A)

 00112902 Shell Chemical Co. (1982) Residue Data Developed from the Use of
             Vendex 4L Miticide on Cherries, Plums and Prunes.  (Compilation;
             unpublished study received Aug 25,  1982 under 201-412; CDL: .
             071061-A)

 00112990 Ebbens, K. (1972) Report to Shell Chemical Company,  a Division of
             Shell Oil Company: Acute Toxicity Studies with SD 14114 Techni-
             cal: IBT No. A1T61.  (Unpublished-study-received on--unknown-date
             under 3G1354; prepared by Industrial Bio-Test Laboratories,
             Inc., submitted by Shell Chemical Co., Washington, DC; CDL:
             093620-G)

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                                    115
                   REGISTRATION STANDARD BIBLIOGRAPHY
      Citations Considered to be Part of the Data Base Supporting
                Registrations Under the Vendex Standard
  MRID            CITATION

00113001 Simpson, B.; Stevenson, D. (1972) Toxicity Studies on the Pesticide
            SD 14114: Two Year Oral Experiment in Rats;  Interim Report  after
            One Year: Group Research Report TLGR.0039.72.   (Unpublished
            study received on unknown date under 3G1354; prepared by Shell
            Research, Ltd., Eng., submitted by Shell Chemical Co., Washing-
            ton, DC; CDL:093620-R)

00113018 Shell Chemical Co. (1974) SD 14114 Residues in  Apples, Pears,
            Citrus, Milk and Tissues from Cows.  (Compilation; unpublished
            study received on unknown date under 4F1492; CDL:093938-B)

00113020 Potter, J. (1974) Characterization of the 1195n Residues in the
            Kidney and Liver of Cows Fed SD 14114-1195n: TIR-22-112-74.
            (Unpublished study received on-unknown date  under 4F1492; sub-
            mitted by Shell Chemical Co., Washington, DC;  CDL:094515-A)

00113029 Loeffler, J. (19??) The Fate of Ingested 119Sn-SD 14114 in Rats:
          .  TIR-22-117-J2^-:XUnpublis^
            4F1492; submitted by Shell Chemical"Co., Washington, DC; CDL:
            094519-H)

00113063 Shell Chemical Co. (1976) The Results of Tests  on the Amount of
            Vendex Residues Remaining, Including a Description of the
            Analytical Methods Used.  (Compilation; unpublished study re-
            ceived Apr 15, 1977 under 7G1947; CDL:096090-C)

00113073 Fink, R.; Beavers, J.; Grimes, J.; et al. (1978)  Acute Oral LD50—
            Bobwhite Quail: SD 14114: Project No. 109-119.  Final rept.
            (Unpublished study received Apr 2, 1979 under 201-369; prepared
            by Wildlife International, Ltd., submitted by Shell Oil Co.,
            Washington, DC; CDL:098036-C)

00113074 Fink, R.; Beavers, J.; Grimes, J.; et al. (1978)  Eight-day Dietary
            LC50—Mallard Duck: SD-14114: Project No. 109-120.  Final rept.
            (Unpublished study received Apr 2, 1979 under 201-369; prepared
            by Wildlife International, Ltd., submitted by Shell Oil Co.,
        •..  Washington, DC; CDL:098036-D)

00113075 Johnson, W. (1972) Acute Toxicity of Technical SD 14114 to Rainbow
            Trout.  (U.S. Fish and Wildlife Service, Fish-pesticide Research
            Laboratory; unpublished study; CDL:098036-H)

00113076 Johnson, W.; Jones, T. (1971) Static Acute Toxicity of SD  14114 to
            Bluegill.  (U.S. Fish and Wildlife Service,  Fish-pesticide Re-
            search Laboratory; unpublished study; CDL:098036-1)

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                                     116
      ... .   •'•     :-.:   OFFICE
                   REGISTRATION STANDARD BIBLIOGRAPHY
      Citations Considered to be Part of the Data Base Supporting
                Registrations Under the Vendex Standard
  MRID            CITATION

00113078 Shell Oil Co. (1979) The Results of Tests on the Amount of Residues
            Remaining, Including a Description of the Analytical Methods
            Used: Vendex.  (Coupilation; unpublished study received Apr 2,
            1979 under 201-369; CDL:098036-K)

00130837 Interregional Research Project No. 4 (1983) The Results of Tests on
            the Amount of Fenbutatin-oxide Residues Remaining in or on Egg-
            plant, Including a•Description of the Analytical Method Used.
            (Compilation; unpublished study received Sep 21, 1983 under 201-
            369; CDL:071955-A)

00143694 Interregional Research Project No. 4 (-19??) The Results of Tests on
            the Amount of Fenbutatin-Oxide Residues Remaining in or on Avo-
            cado Including a Dsecription of the Analytical Method Used.  Un-
            published compilation.  43 p.

00145444 Interregional Research Project No. 4. (19??) The Results of Tests
	on the .Amount MJ"ejib^tatijaTP^ide.JResidues Remaining in or on
            Raspberries Including a Description of the Analytical Method"
            Used.  Unpublished compilation.  49 p.

00146038 Interregional Research Project No. 4 (19??) The Results of Tests on
            the Amount of Fenbutatin-oxice Residues Remaining in or on Cu-
            cumbers Including a Description of the Analytical Method Used.
            Unpublished compilation.  18 P.

00148257 Shell Oil Company (1982) Residue Data Developed from the Use of
            Vendex 4L Miticide on Peaches and Strawberries.  Unpublished
            study.  116 p.

00148733 Shell Oil Co. (1985) Vendex 4L Miticide: Vendex 50WP Water Soluble
            Bag Miticide: Amendment to Strawberries:  [Residue Data in Straw-
            berries].  Unpublished compilation.  40 p.

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