&EPA
             United States
             Environmental Protection
             Agency
             Office of
             Pesticide* and Toxic Subtu
             Washington OC 20460
            Pesticide*
                                      February 1985
Guidance for the
Reregist ration
of Pesticide Products
Containing
 Demeton

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            CAS NUMBER 143

           GUIDANCE FOR THE
 REREGISTRATION OF MANUFACTURING-USE
AND CERTAIN END-USE PESTICIDE  PRODUCTS

               CONTAINING

               DEMETON
               (057601)

            CAS 8065-48-3

     ENVIRONMENTAL PROTECTION  AGENCY

     OFFICE OF PESTICIDE PROGRAMS

       WASHINGTON, D.C.  20460

            February, 1985

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                        TABLE  OF  CONTENTS


      Introduction	  •     1

I.    Regulatory Position  and  Rationale	     4

II.   Requirement for Submission  of Generic Data	     94

III.  Requirement for Submission  of Product-Specific
      Data	     97

IV.   Submission of Revised Labeling and  Packaging
      Information	     98

      A.  Label Contents	     98

          1.  Product Name	     98
          2.  Company Name and Address	     98
          3.  Net Contents	     98
          4.  Product Registration Number	     98
          5.  Producing Establishment
              Registration Number	     98
          6A  Ingredient Statement	     99
          6B  Pounds Per Gallon Statement	     99
          7.  Front Panel  Precautionary Statements  	     99
          7A  Child Hazard Warning Statements	     99
          7B  Signal Word	     99
          7C  Skull and Crossbones and Word Poison	    100
          7D  Statement of Practical Treatment 	    100
          7E  Referral Statement  	    100
          8.  Side/Back Panel  Precautionary Labeling  	    100
          8A  Hazard to Humans and Domestic Animals	    100
          8B  Environmental Hazard 	    100
          8C  Physical or  Chemical Hazard	    100
          9   Product Classification 	 . 	    100
          10  Misuse Statement 	    103
          10A Storage and  Disposal Block 	    103
          10B Directions for Use	    103

      B.  Collateral Information 	    103

V.    Instructions for Submission.	    104

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                           APPENDICES


II-l     Guide to Bibliography

II-2     Bibliography

II-3     FIFRA S3(c)(2)(B)  Summary Sheet - EPA Form 8580-1

II-4     Certification of Attempt to Enter Into an Agreement
          with Other Registrants for Development of Data
          EPA Form 8580-2

III-l     Product Specific Data Report (End-Use Products)

IV-1      40 CFR 162.10 Labeling Requirements

IV-2      Table of Labeling Requirements

IV-3      Physical/Chemical Hazards Labeling Statement

IV-4      Storage and Disposal Instructions
                                ii

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                         INTRODUCTION

     The Federal Insecticide,  Fungicide,  and Rodenticide Act
(FIFRA sec. 3(g), as amended in 1978, directs EPA to
reregister all pesticides as expeditiously as possible.   Each
registrant of a manufacturing use product of the active
ingredient who wishes to continue to sell or distribute that
product must apply for reregistration.

     To carry out this task, we have established the Regis-
tration Standards program, which will review all pesticide
active ingredients first registered before January 1, 1977.
These pesticides will be reviewed in use clusters which are
prioritized on the basis of a ranking scheme giving preference
to pesticides used on food and feed crops.

     The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient.  Our reassessment results in the development
of a regulatory position, contained in this document, on
each pesticide and its uses.  Based on the regulatory position,
the Agency may require the registrant to modify product labels
to provide additional precautionary statements, restrict the
use of the pesticide to certified applicators, provide
reentry intervals, modify uses or formulation types, specify
certain packaging limitations, or other requirements to
assure that proper use of the pesticide poses no potential
adverse effects to human health or the environment.

     The scientific review, which is not contained in this
Guidance Package but is available upon request, concentrates
on the technical grade of the active ingredient and identifies
missing generic data.  However, during the review of these
data we are also looking for potential hazards that may be
associated with the formulated (end use) products that contain
the active ingredient. If we find serious concerns, we will
bring formulated products under the provisions of the Regis-
tration Standards program to the extent necessary to protect
the public.

     EPA has the authority under FIFRA §3(c)(2)(B) to require
that registrants submit data that will answer our questions
regarding the hazard that may result from the intended use of
the pesticide under review.  Further, §3(c)(2)(B) provides
that these data are to be submitted by those registrants who
do not qualify for the formulator's exemption [FIFRA
§3(c)(2)(D)].  Normally, this means that the registrants who
are responsible for filling the data gaps are the manufacturing
use product producers (basic suppliers of the active ingredient)

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However, end-use producers will not qualify for the formulator's
exemption if the source of their active ingredient: (1) is
not registered with EPA, and/or (2) is produced by the regis-
trant's firm, or a firm which has ownership in common with
the registrant's firm.  These end use produce is can qualify
for the formulator's exemption if they change their source of
supply to a registered source, provided the source does not
share ownership in common with the registrant's firm.  If the
end use product registrant decides to switch sources, a new
Confidential Statement of Formula, EPA Form 8570-4, must be
submitted to the appropriate Product Manager within 90 days
of receipt of this Guidance Document.  The chart on the
following page shows what is generally required of those who
do and do not qualify for the formulator's exemption in the
Registration Standards program.

     If you decide to request the Agency to cancel the regis-
tration of any of your products subject to the reregistration
requirements of this Guidance Document, please notify the
Product Manager named in the cover letter, within 90 days
from the receipt of this document, that you wish to voluntarily
cancel the registration(s).  If you decide to maintain your
product registration(s), you must provide the information
described in the following pages within the timeframes
outlined. EPA will issue a notice of intent to cancel or
suspend the registration of any currently registered product
if you fail to comply with the requirements set forth in
this Guidance Document.

    You are reminded that FIFRA sec. 6(a)(2)  requires you at
any time to submit factual information raising concerns of
possible unreasonable adverse effects of a pesticide. You
should notify the Agency of interim results of studies in
progress if those results show possible adverse effects.

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  PRODUCTS SUBJECT TO THE
	REGISTRATION STANDARDS PROGRAM

I. Products That Do Not. Qualify
   For The Formulator's Exemption

   A. Single Active Ingredient
      Products*
  ACTIONTST REOUIRED~TO~
  MAINTAIN REGISTRATION
These products must he reregis- |
tered. To obtain reregistration,;
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
   B. Multiple Active Ingredient
      Products
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required and
some labelTng~precautions may
also be required. There are no
products containing demeton in
this category.
II.  Products That Do Qualify For
     The Formulator1s Exemption
In the case of this Standard,
labeling statements are required
to protect man and the environ-
ment. These products are subject
to certain provisions of this
Standard as described herein.
*End use products of registrants who aTso produce a manufacturing
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing use product(s). Such end use products
will be subject to the labeling changes reguired for products in "II"
above. If there are no manufacturing use products registered by any
company end use products will be required to be reregistered.

NOTE: If all registrants in "I" above fail to meet the requirements in
I-A and R above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and B.

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II.  REGULATORY POSITION AND RATIONALE






A. Introduction






This chapter contains the Agency's regulatory position and




rationale on products containing the pesticide demeton as a




sole active ingredient.  The Agency bases its position and




rationale on a consideration of all uses of demeton appearing




on pesticide products registered under Sections 3 and 24(c)



of the FIFRA as well as on products authorized for distribu-




tion in intrastate commerce under 40 CFR 162.17.  The Agency



has reviewed the known chemical, environmental, and toxico-




logical characteristics of this pesticide and its established




tolerances for residues in or on food and feed commodities.




From these considerations the Agency sets forth the data and



labeling requirements that must be met by registrants and




applicants for registration of demeton manufacturing-use (MP)




products in order for their products to be registered or




reregistered under this Standard.  Unique labeling requirements




and certain data needs for end-use products (EPs) containing




demeton are also established by this Standard.






Only those data and labeling requirements for current



and future substantially similar MPs and EPs are addressed




here.  Applications to register products that differ appreciably




from those described in this Standard may be subject to addition-




al data and/or labeling requirements.

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B *  Pescripti°n °f Chemical
Demeton is the British Standards Institute (BSI) and Entomo-

logical Society of America (ESA) approved common name given

to the chemical mixture consisting of 0 ,0-diethyl 0- [ 2- ( ethylthio)

ethyl] phosphorothioate and 0,f)-diethyl S- [ 2-ethylthio) ethyl]

phosphorothioate.  Other names include Systox , Demeton-0 +

Demeton-S, mercaptophos and mercaptophos teolevy (USSR), Bay

10756, Bayer 8169, E-1059 , Systemox and Demox .  Demeton-S is

also known at Isosystox.  Identifying characteristics and

codes are as follows:

     Empirical Formula:  CpH^gO3PS2
     Molecular Weight:   258.32
     CAS Registry No.:   8065-48-3
     ENT Registry No.:   17295
     Shaughnessy No.:    057601


Technical demeton is a light brown liquid.  Its odor is char-

acteristic of sulfur compounds.  Demeton is soluble in most

organic solvents, and is subject to hydrolysis under alkaline

conditions.  Information on the chemical and physical properties

of technical demeton are for the most part lacking and constitute

data gaps.


Mobay Chemical Corporation is the sole producer of demeton in

the United States and markets its products under the trade

name Systox®.  There is one 85% technical (MP) product and six

(EP) products registered for use in the United States. These

are all single-active ingredient formulations.


Demeton is a systemic acaricide/insecticide registered for

use on vegetable, field, orchard, and ornamental (including

                             5

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greenhouse) sites.  It is formulated into a 1.985% granular



(G) formulation, and 2 and 6 Ib/gal emulsifiable concentrate



(EC) formulations.  Demeton is applied to agricultural crops



as a foliar spray using ground or aerial equipment.  Ornamentals



are treated by applying granules around the base of each



plant,  or alternatively when emulsifiable concentrates are



used,  as a foliar spray or soil drench.  Usage data available



to the  Agency indicate that apples, potatoes and wheat are



the high volume use sites, while Brussels sprouts have the



greatest percentage of the crop acreage treated.  Demeton is



a restricted-use pesticide and applicators must be certified



or be under the direct supervision of applicators certified to



apply demeton [43 FR 5782, February 9, 1978].






C. Regulatory Position and Rationale






Based on a review and evaluation of all available data and



other relevant information on demeton, the Agency has made



the following determinations:






1.  All products containing demeton as a sole active ingredient



    may continue to be registered for sale, distribution,



    reformulation, and use, subject to the terms and conditions



    specified in this Guidance Document.  Registrants must



    provide,  or agree to develop, additional data, as specified



    in  Tables A, B, and C, in order to maintain existing



    registrations or to permit new registrations.






    Rationale: Under FIFRA, the Agency normally does not cancel



    or  withhold registration simply because data are missing



                              6

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    or  inadequate (see  Sections  3(c)(2)(B)  and 3(c)(7)  of

    the  FIFRA).   Rather,  issuance  of  this  Standard  provides

    a mechanism for identifying  data  needs.  These  data will

    be  reviewed and evaluated when they are received and the

    Agency will determine at that  time whether they will

    affect the  registration(s) of  demeton.


2.   The Agency will not allow any  signficant new uses*  to be

    established for demeton until  the toxicological and

    residue chemistry data deficiencies identified  in Table

    A have been satisfied.


    Rationale:  The Agency is unable to complete a tolerance

    reassessment of demeton because of extensive residue chem-

    istry and toxicology data gaps. The data requested in Table

    A are needed for EPA to calculate an acceptable daily intake

    (ADI) level of demeton and its metabolites and to reassess

    the present tolerances.  Refer to Section G. Tolerance

    Reassessment Summary for a complete discussion.  The

    Agency will not allow any significant new uses until the

    toxicological and residue data have been received and evaluated


3.   The Agency is requiring that a gene mutation assay in

    mammalian cells in culture and a chromosome aberration

    assay in vivo be performed to assess the mutagenic potential


    * The terminology "significant new use" is defined in 44
      FR 27934, May 11, 1979.  In the case of a new food or
      feed use, the Agency will generally consider as signif-
      icant an increase in the Theoretical Maximal Residue
      Concentration of greater than  1%.

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    of demeton.  After a review of these  studies,  the Agency



    will  determine whether a  special  review is warrented.






    Rationale;   Six mutagenicity studies  available to the



    Agency demonstrate positive results.   The mutagenicity



    exhibited by demeton is demonstrated  in tests  for point



    mutations and for chromosome aberrations.  Of  the positive




    studies available at this time,  however, all have been



    performed jln vitro in cells.  In  order to better  characterize



    the mutagenic potential of demeton,  a gene mutation



    assay in mammalian cells  in culture  and a chromosome



    aberration  assay in vivo are required.  Depending upon



    the results of the above  studies,  the Agency may  request



    further data.






4.  All end-use products containing demeton shall  continue  to



    be classified for restricted use.






    Rationale:   EPA has very limited  data on the acute toxicity



    of end-use  products containing demeton.  Based on the high



    acute toxicity of the active ingredient, demeton, the Agency



    has determined that demeton products  should continue to



    be classified for restricted use.   Registrants may submit



    data  specified in Table C if they believe that their particular



    product does not warrant  the restricted use classification.



    Refer to Section IV(a) for classification information.






 5.  The Agency  is requiring that pertinent chemistry  and



    environmental fate data be submitted  on an accelerated  basis



    in order to characterize  demeton's potential for  contaminating




    ground water.



                             8

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   Rationale;   At present,  no data  are available  to assess



   the  environmental  fate of  demeton  or to characterize  its



   potential for contaminating ground water.   The Agency



   has  become  increasingly  concerned  about the presence  of



   pesticide chemicals in ground waters in the United States



   and  has identified a number of chemicals,  including



   demeton,  which may have  the potential to enter ground



   waters based on factors  such as  chemical structure,



   solubility  and use patterns. On  March 31,  1984, the



   Agency issued a Special  Data Call-in Notice under FIFRA



   §3(c)(2)(B) requesting  that pertinent data be  submitted



   in an expedient manner  (most data  are due  by March, 1985).






6. The  Agency will continue to require the reentry interval



   of 48 hours established  under 40 CFR 170 for all outdoor



   uses of demeton in order to minimize exposure  to workers



   entering  treated areas,  pending  the receipt and evaluation



   of reentry  data to assess  the potential for exposure  to



   workers handling demeton.






   Rationale:   The Agency  is  concerned about the  possible



   dermal and  inhalation exposure to workers handling demeton



   because of  its high acute  toxicity.  A Federal reentry



   interval  of 48 hours is  set for  all crops under 40 CFR



   170.  Because of demeton's high  acute toxicity, this



   reentry interval is being  retained.  Through this Standard,



   studies are being required to further evaluate demeton's



   exposure  potential.  Based on these submitted  data, EPA may



   impose a  different reentry interval.



                            9

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7.  Pesticide spray drift data requirements are being imposed



    by this Standard.  Data being required include droplet size



    spectrum studies and field evaluation of pesticide drift.






    Rationale: The Agency is concerned about the potential



    hazards to non-target organisms (fish and wildlife,



    domestic animals and humans) caused by drift from aerial



    and ground air-blast applications of demeton.  The Agency



    is imposing these data requirements because demeton is a



    highly toxic pesticide and because demeton may be applied



    by air or ground air-blast equipment.






8a. A study is required to monitor the residues of demeton in



    aquatic sites adjacent to grove/orchards.






    Rationale:  Demeton is very highly toxic to freshwater



    invertebrates.  The Agency calculates that if demeton



    emulsifiable concentrate is applied at the label rate of



    six pounds a.i. per acre to an apple orchard 10 acres in



    size draining into a two acre pond, and assuming a 2%



    loss from the treated area through drift and runoff, the



    resulting concentration in the pond will exceed the



    acute toxicity level for an aquatic invertebrate species.



    Therefore, EPA is requiring field monitoring data which



    will be useful in the evaluation of this exposure calcu-




    lation.






8b. A study to monitor the residues of demeton on avian feed



    items is required.






    Rationale;  Acute toxicity studies indicate that demeton



                              10

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    is very  highly  toxic  to  birds.   Calculations  show  that  a



    direct application of  demeton emulsifiable concentrate



    at a  label  rate of five  to  six  pounds  a.i. per  acre  to



    an apple orchard may  result in  a residue  level  on  avian



    feed  items  greater than  the acute toxicity level  in  an



    avian species.  Therefore, EPA is requiring a  monitoring



    study which will be useful  in the evaluation  of this



    exposure calculation.  Based on the  results of  this  study,



    and  the  outcome of the environmental fate profile, the



    Agency may  request that  an  avian field study  be performed.






    Once the Agency has  reviewed these studies,  it  will



    determine whether  EPA should initiate  a public  interim



    review  process  by  placing the chemical in Special  Review.



    If  instead, regulation of the chemical through  the



    normal  registration  process is  found to be  appropriate,



    the  Agency  will update its  regulatory  position  and rationale



    to  reflect  this conclusion  and  reasoning behind it.






9.  The  Agency will  impose interim  labeling to protect  endangered



    species, if the generic  (cluster) analysis  for  endangered



    species  has not been  completed  in time to impose appropriate



    labeling in time for  the 1986  growing season.  At  this  time,



    no  label statements  are  being  imposed.






    Rationale;   Appropriate  labeling for the protection of



    endangered  species determined  to be in jeopardy is being



    developed in conjunction with a generic  (cluster)  approach,



    rather  than under  this Standard.  This generic  approach,



    which entails the  analysis of the effects of all pesticides



                               11

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    on endangered species on a crop by crop basis, rather




    than a chemical by chemical approach, is being developed




    in cooperation with Federal and State enforcement agencies,




    the Office of Endangered Species (OES) and the U.S.




    Department of Agriculture  (USDA), using the extension services




    and the National Agricultural Chemical Association (NACA)




    Thus, the labeling developed under this approach




    will encompass all endangered species associated with use




    of pesticides on a particular crop.






    The Office of Endangered Species, Fish and Wildlife




    Service, has issued biological opinions for the cotton,




    sorghum, and small grains  (wheat, barley,  oats) clusters.




    The continued existence of the Attwater's greater prairie




    chicken, Aleutian Canada goose, Everglades kite,  slackwater



    darter, woundfin, freshwater mussels, valley elderberry




    longhorn beetle, delta green ground beetle and Kern




    primrose sphinx moth is jeopardized by the uses of several




    pesticides, including demeton, on the above crops.






    It may be determined that more species are jeopardized by



    demeton when other clusters are completed.  It is anticipated




    that appropriate labeling will be developed in time for




    the 1986 growing season. If not, the Agency will impose




    interim labeling to protect endangered species.






10. Registrants of end-use products must submit revised labeling




    which incorporates the label precautions found in Section F.
                              12

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    Rationale;  The Agency believes that label statements



    prescribed in this Guidance Document should minimize the




    acute hazards associated with the oral, dermal, inhalation




    and ocular routes of exposure to users of demeton, and




    should minimize the hazards to terrestrial and aquatic



    organisms.






D. Criteria for Registration Under This Standard






   To conform to this Standard,  products must contain




   demeton as the sole active ingredient, bear required




   labeling, and conform to the product composition, acute




   toxicity limits, and use pattern requirements listed in



   section E of this document.




   The application for registration or reregistration of




   manufacturing-use products subject to this Standard must




   comply with all terms and conditions described in it,




   including submission of an up-to-date Confidential Statement




   of Formula, submission of revised labeling, commitment




   to fill data gaps on the schedule specified by the Agency




   and, when applicable, offer to pay compensation as required




   by 3(c)(l)(D)  and 3{c)(2)(D) of the Federal Insecticide,




   Fungicide and  Rodenticide Act (FIFRA), as amended, 7




   U.S.C. 136(c)(l)(D) and 136(c)(2)(D).  Registrants of




   end-use products who qualify for the Formulator's Exemption




   must submit five (5) copies of draft labeling  incorporating




   the unique label statements identified in Section F.
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E. Acceptable Ranges and Limits


   Product Compos i t ion Standa rd

   To conform to this Standard, manufacturing-use products

   must contain demeton as the sole active  ingredient.  Each

   MP formulation proposed for registration must be fully

   described with an appropriate certification of limits,

   stating maximum and minimum amounts of the active and

   intentionally added inert ingredients which will be present

   in products.


   Acute Toxicity Limits

   The Agency will consider registration of technical grade

   and manufacturing-use products containing demeton, provided

   that the product labeling bears appropriate precautionary

   statements for the acute toxicity category in which each

   product is placed.


   Use Patterns

   To conform to this Standard, manufacturinguse products

   containing demeton may be labeled for formulation  into

   end-use products only for the commodities listed below.

   The attached index entry lists all  registered uses (and

   intrastate label uses*) as well as  approved maximum application

   rates and frequencies.

       0  Terrestrial, non-domestic, food uses on:
          alfalfa/ almond^ apple,aprTcot,  Barley,
          beans, broccoli, Brussels sprouts, cabbage,


   * Intrastate uses have not  been reviewed for  acceptability
     under sec. 3 of the FIFRA.  Therefore,  these uses may not
     be added to any product registered under sec.  3  until the
     supporting data have been submitted, reviewed  and found to
     be acceptable

                        14

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          cauliflower,  celery,  cherry,  cotton,  eggplant,
          filbert,  grapefruit,  grapes,  hops,  lemon,
          peach,  pear,  peas,  pecan,  peppers,  potatoes,
          plums (fresh  prunes), sorghum,  strawberry,
          sugar beets,  tomato,  walnut and wheat.   State
          registration  ( intrastate)  exist for the following
          additional  crops:   trefoil, leafy vegetables
          (including  Chinese cabbages,  mustard greens),
          cucurbits (including  oriental squashes, melons,
          gourds and  pumpkins), yard-long beans,  Chinese
          peas, and endive.
       0   Terrestrial,  non-domestic npj}l£°°l H£!ls on :
          pTneappT~Tnon-Bea r £ rigT", ~s tTone~Fru i t s Tnon-bearing) ,
          ornamental flowering plants (incl. chrysanthemum,
          daffodil, delphinium, lilies, pansies and
          primrose), ornamental flowering shrubs (incl.
          azalea, camellia, roses and viburnum), ornamen-
          tal trees (incl. linden and American holly);
          post-harvest treatment to blackberry, dewberry,
          gooseberry,  loganberry and raspberry.

       0   Greenhouse non-food uses on: ornamental
          FTowerrng~pra77Fs"~rTncTT~chrysanthejnum, daffodils,
          lilies and primrose), ornamental shrubs and
          ornamental trees.

       0   Forestry Uses on: forest tree plantings
          flntraslfaTe laBe 1 ) .


F. Required Labeling

   All manufacturing-use and end-use demeton products must

   bear appropriate labeling as specified in 40 CFR 162.10.

   The guidance package for this Standard contains information

   on label requirements.


   0 Ingredient Statement

   The ingredient statement for MPs and EPs must list the

   active ingredient as:

   demeton:  0,0-diethyl 0- [ 2- ( ethylthio) ethyl] phosphorothioate
             and 0,0-diethyl S- [ 2- ( ethylthio)  ethyl]  phosphorothioate

   0 Use  Pattern Statement

   All manufacturing-use demeton products must  state  that


                               15

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they are  intended for formulation  into end-use products

for the  aforementioned  use  patterns.  Labeling must  specify

sites, which  are  listed  in  Use  Patterns,  Section  5.3.  A

limiting factor will  be data  that  support these  use  patterns.

No use may  be included  on the label where the registrant

fails  to agree to comply with the  data  requirements  in

either Table  A or Table B for that use pattern.  For  intrastate

uses,  the data requirements must be met  first.


°  Precautionary Statements

 Statements for Manufacturing-Use Products

 1.  Labels for manufacturing-use demeton  products  must

    bear statements  reflecting the compound's acute human

    toxicity.   Demeton is in Toxicity  Category I  by the

    dermal and ocular routes of exposure;  required precautionary

    statements associated with this category are  specified

    in 40 CFR 162.10.

2.  The following  revised environmental  hazard statement

    must appear on all MP Labels:

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


  Statements for End-Use Products

  1.   All end-use  products must bear the restricted-use
      statement:

              RESTRICTED USE PESTICIDE
       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.

                           16

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    The basis for the restricted-use classification  must

    appear directly beneath the RESTRICTED USE PESTICIDE

    HEADING.   The basis for the restricted use classifi-

    cation is as follows:

       1.985  percent granular             Acute oral toxicity
       formulation                        and acute  dermal toxicity

       All granular formulations,         Acute dermal toxicity and
       emulsifiable concentrates,         residue effects on mammalian
       and concentrated solutions         and avian  species.


2.  The worker protection statements below must appear on

    all products, if they do not already appear on the

    labeling:

         Wear rubber gloves, protective clothing, rubber
         overshoes and goggles.  Wear a respirator jointly
         approved by the Mine Safety and Health Admini-
         stration (formerly U.S. Bureau of Mines) and the
         National Institute of Occupational Safety and Health.

    If the product is  in Toxicity Category I on the basis of

    inhalation toxicity, the registrant must specify an

    appropriate respirator  for users.


3.  The reentry statement below must appear on all demeton

    products with directions for outdoor use:

         Do not reenter treated fields within 48 hours unless
         appropriate protective clothing  is worn.


4.  In the absence of  crop  rotation data, the crop rotation

    restriction below  must  be placed on all EP's which

    may be used in a situation where rotation with crops

    used for food or feed  that are  not registered with

    demeton may occur:

    Do not rotate with any  food or  feed crop  for which demeton
    is not registered.

                              17

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5.  One of the Environmental Hazard statements listed below

    is required to appear on each EP product:

     Granular
     This pesticide is toxic to fish and wildlife.  Do not
     apply directly to water.  Runoff from treated area may
     be hazardous to aquatic organims in adjacent aquatic
     sites.  Cover or incorporate granules which are spilled,
     Do not contaminate water by cleaning of equipment or
     disposal of wastes.

     Non Granular
     This pesticide is toxic to fish and wildlife.  Do not
     apply directly to water. Runoff and drift from treated
     area may be hazardous to aquatic organisms in adjacent
     aquatic sites.  Do not contaminate water by cleaning of
     equipment or disposal of wastes.


7.  Tolerance Reassessment Summary
    The established tolerances for demeton are published in

    40 CFR 1R0.105 and 21 CFR 561.130.  A summary of these

    tolerances is presented in Table I.


    Sufficient data are available to determine that the

    established tolerances for residues of demeton in or on

    eggplant, sorghum grain and forage, and cottonseed are

    adequate.  However, additional data are required to

    support the tolerances for residues in or on potatoes,

    sugar beet roots and tops, dehydrated sugar beet pulp,

    celery, lettuce, broccoli, Brussels sprouts, cabbage,

    cauliflower, beans, peas, peppers, tomatoes, muskmelons,

    grapefruit, lemons, oranges, apples, pears, apricots,

    nectarines, peaches, plums, grapes, strawberries, almonds,

    almond hulls, filberts, pecans, walnuts, grain of barley,

    oats, and wheat, green fodder and straw of barley, oats,


                              18

-------
and wheat, alfalfa (fresh and hay), clover (fresh and



hay) and hops.






Additional data are needed to determine whether food/feed



additive tolerances must be proposed for the following



processed products:  potato granules, chips and dried



processed potatoes; molasses and refined sugar processed



from sugar beets; bean cannery residue; tomato juice,



puree, catsup and wet and dry pomace; dried pulp, peel,



oil, molasses and juice of citrus; wet and dry pomace



and juice of apples; dried prunes; raisins, juice, raisin



waste, and wet and dry grape pomace; barley germ and



milling products; milled products of oats and wheat;



flour and milled products of sorghum; alfalfa meal;



meal, hulls, soapstock, and crude and refined oil of



cottonseed; and dried and spent hops.






Feeding restrictions or additional data and tolerance



proposals are needed for the following raw agricultural



commodities:  bean vines and hay; pea vines and straw;



and sorghum fodder, silage, and hay.  Also, residue data



and tolerance proposals are needed for oat hulls, hay  of



barley, oats and wheat, and alfalfa seed.  The commodity



definitions for  "green fodder" of barley, oats, and



wheat will be changed to "forage" and the commodity



definitions for  "fresh" alfalfa and clover will be changed



to "forage."



Registrations exist for several commodities for which  no



tolerances have  been established because these uses  have






                          19

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previously been considered to be "non-food" uses.  The 2



and 6 Ib/gal EC formulations are registered for foliar



use on nonbearing cherries, postharvest foliar use on



blackberries, dewberries, gooseberries, loganberries,



and raspberries, and dip treatment to planting stock of



pineapples.  Additional data are needed to determine



whether "non-food"  classification is justified.






Intrastate registrations exist for the following



raw agricultural commodities: Chinese cabbages, mustard



greens, green onions, endive, oriental squash, melons,



gourds, pumpkins, trefoil grown for seed.  Tolerance



proposals and residue data must be submitted if registration




of these uses under sec. 3 of FIFRA is sought.






The metabolism of demeton in plants is adequately understood,



Demeton is readily absorbed and translocated by plants.



Identified metabolites  include 0,0-diethyl O-ethyl-2-



sulfinylethyl phosphorothioate (III), 0,0-diethyl 0-ethyl-



2-sulfonylethyl phosphorothioate (IV), 0,0-diethyl



O-ethyl-2-sulfinylethyl phosphate (VI), 0,0-diethyl



S-ethyl-2-sulfinylethyl phosphorothioate (VIII), and



0,0-diethyl S-ethyl-2-sulfonylethyl phosphorothioate



(IX).  Although not identified, 0,0-diethyl O-ethyl-2-



mercaptoethyl phosphate (V) and 0,0-diethyl O-ethyl-2-



sulfonylethyl phosphate (VII) are expected to  occur



through oxidation of the thiono-isomer of demeton.



Also, 0,0-diethyl phosphorothioate (X), 0,0-diethyl




phosphoric acid (XI), and phosphoric acid  (XII) are






                          20

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metabolites expected to occur through hydrolysis from the




oxidative products of both demeton isomers; compounds X,




XI and XII have been identified as hydrolysis products




of the related pesticide, disulfoton.  Refer to Table II




for a listing of demeton and its metabolites.






No data are currently available regarding  the metabolism




of demeton (0,0-diethyl 0(and S)-2(ethylthio)ethyl pho-




sphorothioates) in livestock.  Therefore,  the nature of




the residue in animals is not adeguately understood.




This constitutes a data gap.






Tolerances published in 40 CFR 180.105 and 21 CFR 561.30




are currently expressed in terms of  residues of demeton




per se.  This definition will be changed to  include the




sum of the combined residues of the  demeton  thiono-isomer




(I), the demeton thiol-isomer (II),  0,0-diethyl O-ethyl-2-




mercaptoethyl phosphate (V) and their  corresponding




sulfoxides (III, VI and VIII) and sulfones  (IV, VII and



IX).  Because of their cholinesterase-inhibiting  properties,




the demeton thiol-isomer (II) and its  sulfoxide (VIII)



and sulfone (IX) and the phosphate  (V) and its  sulfoxide




(VI) and sulfone (VII) are of toxicological  concern.




Although  the  thiono-isomer  (I) and  its sulfoxide  (III)




and sulfone (IV) are not cholinesterase-inhibiting




metabolites per se,  they may be oxidized  to  form




cholinesterase-inhibiting compounds  V  through VII.




Therefore, all of  these metabolites  are  of toxicological




concern and must be  included in the  tolerance definition.




                           21

-------
40 CFR 180.3(d)(2) states that where tolerances are



established for residues of both disulfoton and demeton



on the same raw agricultural commodity, the total amount



of such pesticides shall not yield more residue than



that permitted by the larger of the two tolerances,



calculated as demeton.  The Agency has determined



that tolerances for residues of disulfoton should no



longer be calculated as demeton; that calculation of



residues as disulfoton sulfone is more appropriate.  The



reason for this is that disulfoton sulfone has the



highest molecular weight of disulfoton, demeton, and



their metabolites; thus, calculation of residues in



terms of disulfoton sulfone will result in the most



accurate estimation of total residue present.  Since



disulfoton and demeton share two common metabolites



[0-analog sulfoxide and sulfone of disulfoton = thiolphosphate



sulfoxide and sulfone of demeton (metabolites VIII and



IX in Table 1)], disulfoton 0-analog is identical to



demeton thiol-isomer (II), and because these pesticides



are registered for use on many of the same raw agricultural



commodities,  it is concluded that the tolerance expression



for both should be the same. Therefore, the combined



residues of the demeton thiono-isomer, the demeton



thiol-isomer, O,0-diethyl O-ethyl-2-mercaptoethyl



phosphate and their sulfoxides and sulfones shall be



expressed as disulfoton sulfone in 40 CFR 180.3(d)(2),




40 CFR 180.105 and 40 CFR 561.30.
                          22

-------
The analytical methods for residues in plants are not



adequate  for  enforcement  because  they have not been



shown to  be sufficiently  specific to distinguish between



residues  of demeton  and all other organophosphate pesticides



registered for use on plant commodities having tolerances



for residues  of  demeton.  Therefore, a confirmatory method



which can be  used for the enforcement of residues of



demeton is required.






Although  no tolerances for residues in animal products



presently exist, an  analytical method is available for



collection of residue data provided the residues of



concern include  only the  thiol- and thiono-isomer



and metabolites  III-IX.   If the requested animal metabolism



data indicate additional  residues of concern, then this



method will not  be adequate for residue analysis.



Furthermore,  if  tolerances for residues in animal products



are established  in the future, a decision as to the



suitability of this method for enforcement purposes will



be dependent on  submission of additional data regarding



its specificity  or the availability of an adequate confirmatory



procedure.



The Provisional Acceptable Daily Intake (PADI) of demeton



is 0.005 mg/kg/day.  This is based on i study by Barnes



and Denz  (1954) with a No Observed Effect Level (NOEL) of 0.05



mg/kg/day for whole blood and brain cholinesterase and a



10-fold Safety Factor (SF).






This study is not considered to be adequate to define a NOEL



                          23

-------
for purposes of setting an Acceptable Daily Intake (ADI),



since the experimental design of the study was considered to



be inadequate.  It is being retained on an interim basis



for calculation of the PADI.  The Agency is requiring a



90-day metabolite feeding study to be performed on the



demeton thiolphosphate sulfoxide, which appears to be



the major plant metabolite at the time of harvest and is



also a more potent cholinesterase inhibitor than parent



demeton.



The Provisional Maximum Permissible Intake (PMPI) is



0.30 mg/day based on a 60 kg body weight person.  The



Theoretical Maximum Residue Concentration (TMRC), based



on relevant food factors and established tolerances  is



0.386 mg/day.  Therefore, the TMRC for demeton occupies



129% of the PMPI.



Although the Agency is concerned that the residue con-



centration exceeds the permissible daily intake, no



regulatory action is warranted pending receipt of the



metabolite feeding study and residue chemistry data  with



which to evaluate the magnitude of human dietary exposure



to demeton.  The Agency believes for the reasons provided



below, that the public will be in no immediate danger while



awaiting receipt and evaluation of the requested data.






The TMRC assumes that 100 percent of the crop for which



a tolerance is established  is treated with demeton.  Demeton1s



major uses are apples, potatoes and wheat, and the estimated



percentage of demeton1s use on these crops is low. When



                          24

-------
adjustments are made for the estimated percentage of crops



treated with demeton, the Agency assumes that the ratio



between the residue contribution and the PADI is actually



lower than 129 percent of the PMPI.






The Agency is requesting data pertinent, to the reassessment



on an accelerated  basis as  indicated  in Table A.  The



Agency will not allow any significant new uses for



demeton until these data requirements have been  satisfied.
                           25

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                                       TABLE I
                               SUMMARY OF PRESENT TOLERANCES
                                                      Tolerances (ppm)

Commodity

alfalfa (fresh)
alfalfa (hay)
almonds
almond hulls
apples
apricots
barley fodder (green)
barley straw
barley grain
beans
broccoli
brussels sprouts
cabbage
cauliflower
celery
cherries
clover (fresh)
clover hay
cottonseed
eggplant
filberts
grapefruit
grapes
hops
lemons
lettuce
muskmelons
nectarines
oranges
oat fodder (green)
oat straw
oats grain
peaches
pears
peas
pecans
peppers
plums
potatoes
strawberry
sugar beets
sugar beet pulp
sugar beet tops
sorghum forage
sorghum grain
tomatoes
walnuts
wheat
wheat fodder (green)
wheat straw

a/per se
T Combined residues of demeton-S, demeton-O, and their  sulfoxides and  sulfones.
United States3/ Canada3/ Mexico International (Codex)
5
12
0.75
5
0.75
0.75
5
5
0.75
0.3
0.75
0.75
0.75
0.75
0.75
5
12
0.75
0.3
0.75
0.75
1.25
1.25
0.75
0.75
0.75
0.75
0.75
5
5
0.75
0.75
0.75
0.75
0.75
0.75
0.75
0.75
0.75
0.5
5
5
0.2
0.2
0.75
0.75
0.75
5
5
	 _
- -
0.75

0.75
0.75
-
- -
- -
0.3
0.75
0.75
0.75
0.75
0.75

- -
-
_
-
0.5
0.75
- -
0.5
0.75
0.3
- -
0.5
-
- -
- -
0.75
0.75
0.75
0.75
0.75
0.75
0.2
0.5

- -
-
-
-
0.3
0.75
- -
-
- —
_
—


0.5*
1.0*
-
—
—
—
-
-
-
-
-~

-
—
—
—
0.5*

—
0.5*
—
0.1*
—
0.5*
—
—
—
1.0
—
-
—

0.2*
—
1.0*

—
—
-
—
—
-
—
—
—
                                          26

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                                    TABLE II




                               DEMETON AND ITS METABOLITES




   CODE                        CHEMICAL NAME




    I      n,0-diethyl  r»-2-(ethyltho)ethyl phosphorothioate




   II      0,0-diethyl  S-2(ethyltho)ethyl phosphorothioate




   II      0,0-diethyl  O-ethyl-2-sulfonylethyl phosphorothioate




   TV      0,0-diethyl  O-ethyl-2-sulfonylethyl phosphorothioate




    V      0,f>-diethyl  O-ethyl-2-mercaptoethyl phosphate




   VI      0,0-diethyl  O-ethyl-2-sulfinylethyl phosphate




  VII      0,0-diethyl  O-ethyl-2-sulfonylethyl phosphate




VIII      0,0-diethyl  S-ethyl-2-sulfinylethyl phosphorothioate




  IX       0,0-diethyl  S-ethyl-2-sulfonylethyl phosphorothioate




   X       0,0-diethyl  phosphorothioate




  XI       0,0-diethyl  phosphoric acid




  XII      Phosphoric acid
  ABBREVIATION




demeton thiono-isomer




demeton thiol-iscroer




thionophosphate suIfoxide




thionophosphate sulfone




phosphate




phosphate suIfoxide




phosphate sulfone




thiolphosphate sulfoxide




thiolsphosphate sulfone
                                   27

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                      EPA Index to Pesticide Chemicals

                                   DEMETON

                             Table of Contents

 Site
AGRICULTURAL CROPS
General Warnings and Limitations
Alfalfa
Alfalfa (seed crop)
Almond
Apple
Apricot
Barley (including seed crop)
Beans
Beans, Yard-long
Blackberry
Broccoli
Brussels Sprouts
Cabbage
Cauliflower
Celery
Chinese Peas
Clover
Clover (seed crop)
Cotton
Cucurbits (including oriental squashes, melons, gourds, and
pumpkins)
Dewberry
Eggplant
Endive
2
2
2
3
3
4
4
5
5
5
6
6
6
6
6
6
2
2
7
7
5
7
7
Issued:  12-06-82              III-057601-i
Provisional Update:   1-10-85
                               28

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                     EPA Index to Pesticide Chemicals

                                 DEMETON

                             Table of Contents
Site
Filbert
Gooseberry
Grapefruit
Grapes
Hops
Leafy Vegetables (including Chinese cabbages and mustard
Lemon
Lettuce
Loganberry
Muskmelons
Nectarine
Oats (including seed crop)
Orange
Peach
Pear
Peas
Pecan
Peppers
Pineapple (nonbearing)
Plum
Potato
Prune
Raspberry
Sorghum
Page
7
5
8
8
8
greens) 8
8
9
5
9
4
4
8
4
9
10
10
10
11
11
11
11
5
12
Issued:  12-06-82              III-057601-ii
Provisional Update:  1-10-85
                                 29

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                      EPA Index to Pesticide Chemicals

                                  DEMETON

                             Table of Contents
Site
Stone Fruits (nonbearing)
Strawberry
Sugar Beets
Tomato
Trefoil
Walnut
Wheat (including seed crop)
ORNAMENTALS
General Warnings and Limitations
(Ornamental Plants (herbaceous, woody shrubs, trees and vines))
American Holly
Azalea
Camellia
Chrysanthemum
Daffodils
Forest Tree Plantings
Larkspur (Delphinium)
Lilies
Linden
Ornamental Herbaceous Plants
Ornamental and/or Shade Trees
Ornamental Woody Shrubs
Pansies
Primrose
Page
12
12
12
12
13
13
4
13
13
13
13
13
14
14
13
13
13
14
14
14
13
14
Issued:   12-06-82              III-057601-iii
Provisional Update:  1-10-85
                                30

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                     EPA  Index to Pesticide Chemicals

                                  DEMETON

                             Table of Contents

Site	Page

  Rose                                                              13

  Viburnum                                                          13

  (Ornamental and Forest Greenhouse Plants)

  Ornamental Herbaceous Plants                                      14

  Ornamental and/or Shade Trees                                     14

  Ornamental Woody Shrubs                                           14


AERIAL, MOTHPROOFING AND TANK MIX APPLICATIONS

  Aerial Application                                                15


Listing of Registration Numbers by Site                             16


Appendix B                                                          17
 Issued:   12-06-82              III-057601-iv
 Provisional  Update:   1-10-85
                              31

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                                 EPA Index to Pesticide Chemicals

c05760'l                                      DEMETON*

            TYPE PESTICIDE:  Insecticide, Acaricide (also refer to Nematicide entry)

            FORMULATIONS:
            Tech (85%)
            G    (1.985%)
            EC   (2 Ib/gal, 6 Ib/gal)

            GENERAL WARNINGS AND LIMITATIONS:  RESTRICTED USE PESTICIDE.  Workers
            must not enter areas treated with demeton until 48 hours after applica-
            tion.  If area is to be entered before the end of this interval, protec-
            tive clothing is required.   Wear a mask or respirator effective for pro-
            tection against demeton jointly approved by the Mining Enforcement and
            Safety Administration (formerly the United States Bureau of Mines) and
            the National Institute of Occupational Safety and Health under provisions
            of 30 Code of Federal Regulations Part II.  Wear protective clothing,
            natural rubber gloves, goggles and rubber overshoes.
            Demeton is toxic to fish and wildlife.  Do not apply directly to water.
            Runoff and drift from treated areas may be hazardous to aquatic organisms
            in adjacent aquatic sites.   Cover or incorporate granules which are
            spilled.
            Bee Caution:
            Demeton is toxic to bees exposed to direct treatment.  Do not apply deme-
            ton while bees are actively visiting the treatment area.
            Definition of Terms:
            Claims for pest control limited to suppression of population are indicated
            by parenthesized pest name.
            *0,0-diethyl 0-[2-(ethylthio)ethyl] phosphorothioate and 0,0-diethyl
              S-[2-(ethylthio)ethyl] phosphorothioate

            Issued:  12-06-82              III-057601-1
            Provisional Update:  1-10-85
                                               32

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/23001AA
/23003AA
IRACAAA
ILAAABA
/23001BA
/23003BA
IRACAAA
ILAAABA
            Site and Pest
            AGRICULTURAL CROPS
                    EPA Index to Pesticide  Chemicals

                                DEMETON

                      Dosages and   Tolerance, Use, Limitations
                      Formulation(s)
            General Warnings and Limitations:  Unless otherwise specified, apply per
            acre rates in sufficient water for thorough coverage by ground equipment
            and in a minimum of 1 gallon of water per acre by aircraft.  For per 100
            gallon rates, apply with conventional hydraulic type sprayers.  When lower
            volumes of spray are applied per acre with concentrate sprayers, increase
            the concentration of demeton in the spray mixture in order to apply an
            amount of active ingredient per acre equivalent to a full coverage spray.
            Where conditions dictate an aerial application, apply the dosage per acre
            equivalent to a full coverage spray in not less than 1 gallon of water
            per acre.  When low volumes of spray are applied, complete coverage is
            essential.
            Do not plant any crops used for food or feed in demeton treated soils
            other than those with registered demeton uses.
            Resistance to demeton:  Due to spotted alfalfa aphid resistance to organo-
            phosphates, in certain areas demeton used alone may not provide satisfac-
            tory control.  Consult state cooperative extension service for additional
            information.
Alfalfa
Clover
  Aphids
  Mites
Alfalfa (seed crop)
Clover (seed crop)
  Aphids
  Mites
              5 ppm (fresh)
              12 ppm (hay)
              21 day preharvest/pregrazing inter-
              val through 0.25 pound per acre for
              foliar application.
              Do not make more than 1 application
              per cutting.
              Observe resistance statement.

0.25 Ib/A     Foliar application.  Apply in a
(2-6 lb/      minimum of 2 gallons of water per
 gal EC)      acre by aircraft or in a minimum of
              10 gallons of water per acre by
              ground equipment.

              12 ppm (hay)
              Chaff and hulls from treated seed
              crop may be used for feed, however,
              do not use greenchop for feed or
              forage.
              15 day preharvest interval through
              0.5 pound per acre for foliar appli-
              cation to seed crop.
              Observe resistance statement.

0.25-0.5 Ib/A Foliar application to seed crop.
(2-6 lb/      Apply in a minimum of 2 gallons of
 gal EC)      water per acre by aircraft or in a
              minimum of 10 gallons of water per
            Issued:  12-06-82
                             III-057601-2
                                               33

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            Site and Pest
                    EPA Index to Pesticide  Chemicals

                                DEMETON

                      Dosages and   Tolerance, Use, Limitations
                      Formulation(s)
              Alfalfa (seed crop) cluster (continued)
/03001AA
Almond
IRACAAA
ILAAABA
/04001AA
  Aphids
  Mites
Apple
IRACAAA
  Aphids
ILAAABA
  Mites
0.75 Ib/A
(2-6 lb/
 gal EC)
acre by ground equipment.  Repeat
as needed.

0.75 ppm
5 ppm (hulls)
21 day preharvest interval through
0.75 pound per acre for foliar ap-
plication.
Do not make more than 1 application
during the growing season.

Foliar application.
              0.75 ppm
              21 day preharvest interval through
              6 pounds per acre for foliar appli-
              cation.
              Do not apply rates through 0.25
              pound per hundred gallons (3 pounds
              per acre) more than 3 times per
              season.
              Do not apply rates through 0.5 pound
              per hundred gallons (6 pounds per
              acre) more than 1 time per season.

0.125-0.5 lb/ Foliar application.  For aphids and
 100 gal      mites, apply the low rate for pre-
 [max 1,200   ventative spray programs and the
 gal/A]       high rate for established popula-
(2-6 lb/      tions.
 gal EC)

0.188-0.5 lb/
 100 gal
 [max 1,200
 gal/A]
(2-6 lb/
 gal EC)
            Issued:  12-06-82
                             III-057601-3
                                                34

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ITAPACA
            Site and Pest
Apple (continued)

  Unspotted tenti-
   form leafminer
IRAFBAA
  White apple leaf-
   hopper
/05001AA
/05003AA
/05004AA
IRACAAA
ILAAABA
Apricot
Nectarine
Peach
  Aphids
  Mites
                    EPA Index  to  Pesticide Chemicals

                                DEMETON

                      Dosages and   Tolerance, Use, Limitations
                      Formulation(s)
0.25 lb/
 100 gal
 [max 1,200
 gal/A]
(2-6 lb/
 gal EC)

0.125-0.25
 lb/100 gal
 [max 1,200
 gal/A)
(2-6 lb/
 gal EC)

              0.75 ppm
              30 day preharvest interval through
              2 pounds per acre for foliar appli-
              cation.
              Do not make more than 3 applications
              during the growing season.
/24001AA
/24001DA
/24003AA
/24003DA
/24007AA
/24007DA
0.25 lb/
 100 gal
 [max 800
 gal/A]
(2-6 lb/
 gal EC)
Barley (including seed crop)

Oats (including seed crop)

Wheat (including seed crop)
Foliar application.
              0.75 ppm (grain)
              5 ppm (green fodder and straw)
              45 day preharvest interval through
              0.25 pound per acre for foliar ap-
              plication (grain).
              21 day preharvest/pregrazing inter-
              val through 0.25 pound per acre for
              foliar application (forage and fod-
              der).
              Do not make more than 2 applications
              during the growing season.
              Allow a minimum of 14 days between
              application.
              No limitation on number of applica-
              tions or preharvest interval for
              seed crops.  Do not use treated seed
              crop for food, feed or forage.
            Issued:  12-06-82
                             III-057601-4
                                                35

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                                  EPA Index to Pesticide  Chemicals
             Site and Pest
                                DEMETON

                      Dosages and   Tolerance, Use, Limitations
                      Formulation(s)
                      (including seed crop) cluster (continued)
 IRACAAA
ILAAABA
/15027AA
IRACAAA
ILAAABA
  Aphids
  Mites
Beans
  Aphids
  Mites
              Beans, Yard-long
/01002AA
/01004AA
/01013AA
/01005AA
/01006AA

IRACAAA
IRAFAAA
ILAAABA
Blackberry
Dewberry
Gooseberry
Loganberry
Raspberry

  (Aphids)
  (Leafhoppers)
  (Mites)
0.125-0.25
 Ib/A
(2-6 lb/
 gal EC)

0.25 Ib/A
(2-6 lb/
 gal EC)
0.375-0.5
 Ib/A
(2-6 lb/
 gal EC)
0.25-0.5
 lb/100 gal
(2-6 lb/
 gal EC)
Foliar application.
              0.3 ppm
              21 day preharvest interval through
              0.5 pound per acre for foliar ap-
              plication.
Foliar application.
needed.
Repeat as
              This use occurs only on Intrastate
              labeling and has not been included
              in this entry.  Refer to appropriate
              labeling for use information and
              limitation.

              N.F.
              Do not apply more than 1.5 pounds
              per acre.
Postharvest application.  Apply up
to 600 gallons of finished spray
per acre, at the low rate and up to
300 gallons of finished spray per
acre at the high rate.  Apply in
the late summer or fall months for
reduction of infestations and to
permit further plant growth.
            Issued:   12-06-82
                             III-057601-5
                                                36

-------
/13005AA
/13006AA
/13007AA
/13009AA
IRACAAA
            Site and Pest
Broccoli
Brussels Sprouts
Cabbage
Cauliflower
  Aphids
EPA Index to Pesticide Chemicals

            DEMETON

   Dosages  and   Tolerance, Use, Limitations
   Formulation(s)

                0.75  ppm
                21 day  preharvest  interval  through
                0.5 pound  per  acre for  foliar  ap-
                plication.
                Transplant water application through
                0.5 pound  per  100  gallons of water.
              Brussels Sprouts

              Cabbage

              Cauliflower
/28003AA
IRACAAA
ILAAABA
  Aphids
  Mites
              Chinese Peas
              Clover
              Clover (seed crop)
   0.5  Ib/A
     or
   0.5  lb/100
    gal trans-
    plant  water
   (2-6 lb/
    gal EC)
                      See Broccoli cluster.

                      See Broccoli cluster.

                      See Broccoli cluster.
Foliar application.  First applica-
tion may be applied in transplant
water.
   0.25  lb/
    100  gal
    [max 200
    gal/A]
   (2-6  lb/
    gal  EC)
0.75 ppm
28 day preharvest interval through
0.5 pound per acre for foliar ap-
plication.

Foliar application.
                                                   This use  occurs  only on  Intrastate
                                                   labeling  and  has not been  included
                                                   in  this entry.   Refer  to appropriate
                                                   labeling  for  use information and
                                                   limitation.
                      See Alfalfa cluster.

                      See Alfalfa (seed crop) cluster.
            Issued:  12-06-82
                              III-057601-6
                                                 37

-------
                                  EPA Index to Pesticide  Chemicals
 /28007AA
IRACAAA
ILAAABA
IMOAAAA
             Site and Pest
Cotton
  Aphids
  Mites
  Thrips
          DEMETON

Dosages and   Tolerance, Use, Limitations
Formulation(s)

              0.75 ppm (cottonseed)
              21 day preharvest interval through
              0.375 pound per acre for foliar ap-
              plication.
              Do not allow livestock or dairy
              animals to graze on treated areas.
              Do not feed gin waste to livestock.
0.375 Ib/A
(2-6 lb/
 gal EC)

0.25 Ib/A
(2-6 lb/
 gal EC)
              Cucurbits (including oriental
               squashes, melons, gourds, and
               pumpkins)
Foliar application.
needed.
Repeat as
                                    This use occurs only on Intrastate
                                    labeling and has not been included
                                    in this entry.  Refer to appropriate
                                    labeling for use information and
                                    limitation.
/11001AA
Dewberry

Eggplant
                                    See Blackberry cluster.
IRACAAA
  Aphids
              Endive
                                    0.25-0.375
                                     Ib/A
                                    (2-6  lb/
                                     gal  EC)
/03005AA
Filbert
              0.3 ppm
              7 day preharvest interval through
              0.375 pound per acre for foliar ap-
              plication.
              Do not make more than 2 applications
              during the  growing season.

              Foliar application.
              This  use occurs only on Intrastate
              labeling and has not been included
              in this  entry.   Refer to appropriate
              labeling for use information and
              limitation.

              0.75  ppm
              40 day preharvest interval  through
              2.5 pounds per  acre  for foliar  ap-
              plication.
            Issued:   12-06-82
                             III-057601-7
                                               38

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

                                              DEMETON
IRACAAA
            Site and Pest
              Filbert (continued)
  Aphids
/02002AA
/02004AA
/02006AA
IRACAAA
IRACFZA
Gooseberry

Grapefruit
Lemon
  Aphids
  Citrus red mite
/01014AA
IRAFAAA
ILAAABA
/08020AA
IRACAAA
  Leafhoppers
  Mites
                      Dosages and   Tolerance, Use, Limitations
                      Formulation(s)
                                                  Foliar application.
                                                  needed.
0.25 lb/
 100 gal
 [max 1,000
 gal/A]
(2-6 lb/
 gal EC)
                                    See Blackberry cluster.
                     Repeat as
0.25 lb/
 100 gal
 [max 1,000
 gal/A]
(2-6 lb/
 gal EC)
0.375 Ib/A
(2-6 lb/
 gal EC)
  Aphids              0.25 lb/
                       100 gal
                       [max 200
                       gal/A]
                      (2-6 lb/
                       gal EC)

Leafy Vegetables  (including Chi-
 nese cabbages and mustard greens)
0.75 ppm
21 day preharvest interval through
2.5 pounds per acre for foliar ap-
plication.

Foliar application.
1.25 ppm
21 day preharvest interval through
0.375 pound per acre for foliar ap-
plication.

Foliar application.
              1.25 ppm
              21 day preharvest interval through
              0.5 pound per acre for foliar ap-
              plication.

              Foliar application.
                                                  This use occurs only on Intrastate
                                                  labeling and has not been  included
                                                  in this entry.  Refer  to appropriate
                                                  labeling for use information and
                                                  limitation.
            Issued:  12-06-82
                             III-057601-8
                                                 39

-------
/13020AA
IRACAAA
             Site and Pest
              Lemon
Lettuce
  Aphid s
/10006AA
IRACAAA
IRAFADA
ILAAABA
Loganberry

Muskmelons
  Aphids
  Beet leafhopper
  Mites
              Nectarine
              Oats
/04003AA
Pear
IRACAAA
ILAAABA
  Aphids
  Mites
EPA Index to Pesticide Chemicals

            DEMETON

  Dosages and   Tolerance, Use,  Limitations
  Formulation(s)

  See Grapefruit cluster.

                0.75  ppm
                21 day preharvest  interval through
                0.5 pound per  acre for  foliar ap-
                plication.

  0.25-0.5 lb/  Foliar application.  Apply up to
    100 gal      200 gallons of finished spray per
  (2-6 lb/      acre  at the low rate and up to 100
    gal EC)      gallons of finished spray per acre
                at the high rate.

  See Blackberry cluster.

                0.75  ppm
                21 day preharvest  interval through
                0.375 pound per  acre for foliar ap-
                plication.

  0.375  Ib/A    Foliar application.  Repeat as need-
  (2-6 lb/      ed.  For band  applications, reduce
    gal EC)      the dosage in  porportion to the
                amount of acreage  actually sprayed.

  See Apricot cluster.

  See Barley cluster.

  See Grapefruit cluster.

  See Apricot cluster.

                0.75 ppm
                21 day preharvest  interval through
                2.25 pounds per  acre for foliar ap-
                plication.
                Do not make more than 3 applications
                during the growing season.

  0.188 lb/     Foliar application.
    100 gal
    [max 900
   gal/A]
  (2-6 lb/
   gal EC)
            Issued:  12-06-82
                             III-057601-9

-------
ITAPACA
            Site and Pest
Pear (continued)

  Unspotted tenti-
   forra leafrainer
/15009AA
IRACAAA
Peas
  Aphids
/03008AA
IRACAAA
ILAAABA
Pecan
  Aphids
  Mites
/28017AA
IRACAAA
Peppers
   Aphids
                    EPA  Index  to Pesticide Chemicals

                                DEMETON

                      Dosages and   Tolerance, Use, Limitations
                      Formulation(s)
0.25 lb/
 100 gal
 [max 900
 gal/A]
(2-6 lb/
 gal EC)

              0.75 ppm
              21 day preharvest interval through
              0.5 pound per acre for foliar ap-
              plication.
0.25 lb/
 100 gal
 [max 200
 gal/A]
(2-6 lb/
 gal EC)
0.25  lb/
  100  gal
  [max 400
  gal/A]
(2-6  lb/
  gal  EC)
 0.375  Ib/A
 (2-6  lb/
  gal  EC)
Foliar application.
              0.75 ppm
              21 day preharvest interval through
              1 pound per acre for foliar appli-
              cation.
Foliar application.
needed.
Repeat as
               0.75  ppm
               3  day preharvest  interval through
               0.375 pound  per acre  for foliar ap-
               plication.
Foliar application.
needed.
                                                                        Repeat  as
             Issued:   12-06-82
                              111-057601-10
                                                41

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

                                DEMETON

                      Dosages and   Tolerance,  Use,  Limitations
                      Formulation(s)
/06013DA
ILAAABA
Pineapple (nonbearing)
  Mites
/05005AA
/05006AA
Plum
Prune
IRACAAA
ILAAABA
  Aphids
  Mites
/14013AA
IRACAAA
IRAFAAA
Potato
  Aphids
  Leafhoppers
              Prune
              Raspberry
0.5 lb/
 100 gal
 [dipping
 emulsion]
(2-6 lb/
 gal EC)
0.25-0.375
 lb/100 gal
 [max 800
 gal/A]
(2-6 lb/
 gal EC)
0.188-0.5
 Ib/A
(2-6 lb/
 gal EC)
N.F.
Do not handle stock with bare hands.

Dip treatment to planting stock.
For temporary protection.
0.75 ppm plums (fresh prunes)
30 day preharvest interval through
0.25 pound per hundred gallons (2
pounds per acre) for foliar appli-
cation.
Do not make more than 3 applications
during the growing season.
60 day preharvest interval through
0.375 pound per hundred gallons (3
pounds per acre) for foliar appli-
cation.
Do not make more than 2 applications
during the growing season.

Foliar application.
0.75 ppm
21 day preharvest interval through
0.5 pound per acre for foliar ap-
plication.

Foliar application.  Repeat as
needed.
                      See Plum cluster.
                      See Blackberry cluster.
            Issued:  12-06-82
                             III-057601-ll
                                                42

-------
/28019AA
IRACAAA
ILAAABA
/05000DA

IRACAAA
ILAAABA
/01016AA
IRACAAA
ILAAABA
/28020AA
IRACAAA
ILAAABA
/11005AA
IRACAAA
ILAAABA
            Site and Pest
Sorghum
EPA Index to Pesticide Chemicals

             DEMETON

   Dosages  and    Tolerance,  Use,  Limitations
   Formulation(s)

                 0.2  ppm (grain)
                 0.2  ppm (forage)
                 35 day preharvest/pregrazing inter-
                 val  through 0.25 pound per  acre.
                 Do not make more than 1 application
                 during the  growing season.
  Aphids
  Mites
   0.25 Ib/A
   (2-6 lb/
    gal EC)
Stone Fruits (nonbearing)
  Aphids
  Mites
Strawberry
  Aphids
  Mites (excluding
   cyclamen mite)

Sugar Beets
  Aphids
  Mites
Tomato
  Aphids
  Mites
   0.25-0.5 lb/
    100 gal
   (2-6 lb/
    gal EC)
   0.375 Ib/A
   (2-6 lb/
    gal EC)
   0.5 Ib/A
   (2-6 lb/
    gal EC)
   0.25-0.375
    lb/100 gal
   (2-6 lb/
    gal EC)
Foliar application.
N.F.

Foliar application.
ed.
Repeat as need-
0.75 ppm
21 day preharvest interval through
0.375 pound per acre for foliar ap-
plication.

Foliar application.
0.5 ppm (sugar beets)
5 ppm (tops)
5 ppm (sugar beet pulp)
30 day preharvest interval through
0.5 pound per acre.
Do not make more than 3 applications
during the growing season.

Foliar application.
0.75 ppm
3 day preharvest interval through
0.375 pound per acre for foliar ap-
plication.

Foliar application.  Apply up to
150 gallons of  finished spray per
acre at the low rate and up to 100
gallons of finished spray per acre
at the high rate.
            Issued:  12-06-82
                              111-057601-12
                                              43

-------
/03009AA
IRACAAA
ILAAABA
            Site and Pest
              Trefoil
Walnut
  Aphids
  Mites
              Wheat
                    EPA  Index  to Pesticide Chemicals

                                DEMETON

                      Dosages and   Tolerance, Use, Limitations
                      Formulation(s)
              This use occurs only on Intrastate
              labeling and has not been included
              in this entry.  Refer to appropriate
              labeling for use information and
              limitation.

              0.75 ppm
             - 21 day preharvest interval through
              0.75 pound per acre for foliar ap-
              plication.
              Do not apply more than 1 application
              during the growing season.

0.75 Ib/A     Foliar application.  May be applied
(2-6 lb/      in combination with codling moth
 gal EC)      spray.

See Barley cluster.
            ORNAMENTALS

            General Warnings and Limitations:  Do not apply within 5 days of hand-
            picking, pruning, transplanting, or other handling.  Phytotoxicity has
            occurred on African violets, cibotium ferns, and Croft lilies.   Caution
            should be exercised when treating these plants.

              (Ornamental Plants (herbaceous, woody shrubs, trees and vines))

/35142AA      American Holly
/34022AA      Azalea
/34036AA      Camellia
/31065AA      Chrysanthemum
/31129AA      Larkspur (Delphinium)
/31131AA      Lilies
/35075AA      Linden
/31149AA      Pansies
/34120AA      Rose
/34137AA      Viburnum

IRACAAA         Aphids (including
                 greenbug and rose
                 aphid)
ILAAAIA         Bulb mites
IRAKBEA         Camelia scale
ILAVASA         European red mite
IRAXAAA         Lace bugs
IRAKAZA         Tea scale
IMOAAAA         Thrips

            Issued:  12-06-82              111-057601-13
                      1 oz 1.985%   Soil application.   Apply around the
                       G/18-24 in.  base of each plant.  For larger
                       high plant   plants, use proportionately  more.
                      (1.985% G)    Water thoroughly after application.
                                    Repeat at 21 day intervals.
                                                44

-------
ILAVBEA

IRABAAA
            Site and Pest
                    EPA Index to Pesticide Chemicals

                                DEMETQN

                      Dosages and   Tolerance, Use, Limitations
                      Formulation(s)
American Holly cluster (continued)

  Pest list continued from previous page.

  Twospotted spider-
   mite
  Whiteflies
              Daffodils
                                    Refer to Nematicide entry.
              Forest Tree Plantings
                                                  This use occurs only on Intrastate
                                                  labeling and has not been included
                                                  in this entry.  Refer to appropriate
                                                  labeling for use information and
                                                  limitation.
                                                  Careful observation by a qualified
                                                  biologist must be made of wildlife
                                                  utilizing areas treated with demeton
                                                  during and after application.
              Ornamental Herbaceous Plants
                                    Refer  to  (Ornamental and Forest Greenhouse
                                    Plants),  Herbaceous Plants cluster for additional
                                    information.
              Ornamental and/or  Shade Trees
                                    Refer  to  (Ornamental and Forest Greenhouse
                                    Plants),  Herbaceous Plants cluster for additional
                                    information.
              Ornamental Woody  Shrubs
              Primrose
                                    Refer  to  (Ornamental and Forest Greenhouse
                                    Plants),  Herbaceous Plants cluster for additional
                                    information.
                                     Refer  to  Nematicide entry.
            Issued:   12-06-82
                              111-057601-14
                                                 45

-------
/31000CA
/35000CA
/34004CA
/31000AA
/35000AA
/34004AA

IRACAAA
IRAWAAA
ILAAABA
IRABAAA

ISBEAMA
IOAHASA
IOABALA
IQAXAAA

IRAKBEA
IRAKA1A
IRAHAAA
IRAKAZA
            Site and Pest
                   EPA Index to Pesticide Chemicals

                                DEMETON

                      Dosages and   Tolerance.  Use.  Limitations
                      Formulation(s)
(Ornamental and Forest Greenhouse Plants)

Ornamental Herbaceous Plants
Ornamental and/or Shade Trees
Ornamental Woody Shrubs
  Aphids
  Mealybugs
  Mites
  Whiteflies

  Birch leafminer
  Boxwood leafminer
  Holly leafminer
  Lace bugs

  Camellia scale
  Howard scale
  Soft scale insects
  Tea scale
0.25-0.375    Foliar application.  Repeat as
 lb/100 gal   needed.
(2-6 lb/                  OR
 gal EC)      Soil drench:
              One pint finished spray per square
0.375-0.5     foot of bench or bed area.   Repeat
 lb/100 gal   as needed.
(2-6 lb/                  OR
 gal EC)      0.25 pint finished spray per 6 inch
              pot.  Repeat as needed.
0.5 lb/                   OR
 100 gal      Apply to the base of each plant.
(2-6 lb/      One to 2 gallons of finished spray
 gal EC)      per shrub or tree up to 6 feet high.
              Apply proportionately more for tal-
              ler plants.  Repeat as needed.
            AERIAL, MOTHPROOFING AND TANK MIX APPLICATIONS
9001500
AAAAAAA
Aerial Application
                                    Refer to
                                    AGRICULTURAL CROPS
                                                  Alfalfa, Alfalfa (seed crop), Al-
                                                  mond, Apple, Apricot, Barley (in-
                                                  cluding seed crop), Beans, Black-
                                                  berry, Broccoli, Brussels Sprouts,
                                                  Cabbage, Cauliflower, Celery,
                                                  Clover, Clover (seed crop), Cotton,
                                                  Dewberry, Eggplant, Filbert, Goose-
                                                  berry, Grapefruit, Grapes, Hops,
                                                  Lemon, Lettuce, Loganberry, Musk-
                                                  melons, Nectarine, Oats, Orange,
                                                  Peach, Pear, Peas, Pecan, Peppers,
                                                  Plum, Potato, Prune, Raspberry,
                                                  Sorghum, Stone Fruits (nonbearing),
                                                  Strawberry, Sugar Beets, Tomato,
                                                  Walnut, Wheat
             Issued:   12-06-82
                              111-057601-15
                                                   46

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

                                              DEMETON

            Listing of Registered Pesticide Products  by Formulation

&085.0001   85% technical chemical
              demeton (057601)
                003125-00008

&001.9804   1.985% granular
              demeton (057601)
                000456-00044

&102.0012   2 Ib/gal emulsifiable concentrate
              demeton (057601)
                002749-00115

              demeton (057601) plus aromatic petroleum distillate (006601)
                003125-00004

              demeton (057601) plus xylene (086802)
                002749-00200

&106.0012   6 Ib/gal emulsifiable concentrate
              demeton (057601) plus aromatic petroleum distillate (006601)
                003125-00221

              demeton (057601) plus xylene (086802)
                002749-00192
9999999     State Label Registrations

            CA Reg. No.
                003125-07842   003125-07843   010965-09902

            FL Reg. No.
                037347-10563

            HI Reg. No.
                037843-08583
            Issued:  12-06-82
111-057601-16
                                                47

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

                                              DEMETON

                                             Appendix B

            Listing of Registration Numbers by Site

            AGRICULTURAL CROPS

/23001AA      Alfalfa
                002749-00115   002749-00192   002749-00200

/23001BA      Alfalfa (seed crop)
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/03001AA      Almond
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/04001AA      Apple
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/05001AA      Apricot
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/24001AA      Barley (including seed crop)
/2400IDA
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/15027AA      Beans
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/01002AA      Blackberry
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/13005AA      Broccoli
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/13006AA      Brussels Sprouts
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/13007AA      Cabbage
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/13009AA      Cauliflower
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221
            Issued:  12-06-82
111-057601-17
                                                  48

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

                                               DEMETON

                                             Appendix 6

             Listing  of  Registration Numbers by Site  (continued)

 /28003AA       Celery
                 002749-00115    002749-00192    002749-00200   003125-00004
                 003125-00221

 /23003AA       Clover
                 002749-00115    002749-00192    002749-00200

 /23003BA       Clover (seed  crop)
                 002749-00192    002749-00200    003125-00004   003125-00221

 /28007AA       Cotton
                 002749-00115    002749-00192    002749-00200   003125-00004
                 003125-00221

 /01004AA       Dewberry
                 002749-00115    002749-00192    002749-00200   003125-00004
                 003125-00221

 /11001AA       Eggplant
                 002749-00115    002749-00192    002749-00200   003125-00004
                 003125-00221

 /03005AA       Filbert
                 002749-00115    002749-00192    002749-00200   003125-00004
                 003125-00221

 /01013AA       Gooseberry
                 002749-00115    002749-00192    002749-00200   003125-00004
                 003125-00221

 /02002AA       Grapefruit
                 002749-00115    002749-00192    002749-00200   003125-00004
                 003125-00221

 /01014AA       Grapes
                 002749-00115    002749-00192    002749-00200   003125-00004
                 003125-00221

 /08020AA       Hops
                 002749-00115    002749-00192    002749-00200   003125-00004
                 003125-00221

/02004AA       Lemon
                 002749-00115    002749-00192   002749-00200   003125-00004
                 003125-00221

/13020AA      Lettuce
                 002749-00115    002749-00192   002749-00200   003125-00004
                003125-00221
            Issued:  12-06-82
111-057601-18
                                                49

-------
/01005AA
/24003AA
/24003DA
/02006AA
                     EPA Index to Pesticide Chemicals

                                  DEMETON

                                Appendix B

Listing of Registration Numbers by Site (continued)

  Loganberry
    002749-00115   002749-00192   002749-00200   003125-00004
    003125-00221
/10006AA      Muskmelons
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221
/05003AA      Nectarine
    002749-00115   002749-00192    002749-00200   003125-00004
    003125-00221

  Oats (including seed crop)

    002749-00115   002749-00192    002749-00200   003125-00004
    003125-00221

  Orange
    002749-00115   002749-00192    002749-00200   003125-00004
    003125-00221
/05004AA      Peach
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/04003AA      Pear
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/15009AA      Peas
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/03008AA      Pecan
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/28017AA      Peppers
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/06013DA      Pineapple (nonbearing)
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/05005AA      Plum
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221
            Issued:  12-06-82
                              111-057601-19
                                                50

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                                  EPA Index to Pesticide Chemicals

                                              DEMETON

                                             Appendix B

            Listing of Registration Numbers by Site  (continued)

/14013AA      Potato
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/05006AA      Prune
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/01006AA      Raspberry
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/28019AA      Sorghum
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/05000DA      Stone Fruits  (nonbearing)
                002749-00192   002749-00200   003125-00004   003125-00221

/01016AA      Strawberry
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/28020AA      Sugar Beets
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/11005AA      Tomato
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/03009AA      Walnut
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221

/24007AA      Wheat (including seed crop)
/24007DA
                002749-00115   002749-00192   002749-00200   003125-00004
                003125-00221
/35142AA
ORNAMENTALS

  (Ornamental Plants (herbaceous, woody shrubs, trees and vines))

  American Holly
    000456-00044
            Issued:  12-06-82
                               111-057601-20
                                                51

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/34022AA


/34036AA


/31065AA


/31129AA


/31131AA


/35075AA


/31000AA



/35000AA



/34004AA



/31149AA


/34120AA


/34137AA




/31000CA



/35000CA
                     EPA Index to Pesticide Chemicals

                                  DEMETON

                                Appendix 8

Listing of Registration Numbers by Site (continued)

  Azalea
    000456-00044

  Camellia
    000456-00044

  Chrysanthemum
    000456-00044

  Larkspur (Delphinium)
    000456-00044

  Lilies
    000456-00044

  Linden
    000456-00044

  Ornamental Herbaceous Plants
    002749-00115
    003125-00221
                 002749-00192    002749-00200    003125-00004


Ornamental and/or Shade  Trees
    002749-00115
    003125-00221
                 002749-00192    002749-00200    003125-00004
  Ornamental Woody Shrubs
    002749-00115002749-00192   002749-00200
    003125-00221

  Pansies
    000456-00044

  Rose
    000456-00044

  Viburnum
    000456-00044

  (Ornamental and Forest Greenhouse Plants)

  Ornamental Herbaceous Plants
                                               003125-00004
    002749-00115
    003125-00221
                 002749-00192    002749-00200    003125-00004
  Ornamental and/or Shade Trees
                002749-00115
                003125-00221
                   002749-00192   002749-00200   003125-00004
            Issued:  12-06-82
                               111-057601-21
                                                52

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                                 EPA  Index  to Pesticide Chemicals

                                              DEMETON

                                            Appendix B

            Listing of Registration Numbers by Site (continued)

/34004CA      Ornamental Woody Shrubs
                000456-00044   002749-00115   002749-00192   002749-00200
                003125-00004   003125-00221
            Issued:   12-06-82               111-057601-22
                                                53

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                                                           TABLE A
                                       GENERIC DATA REQUIREMENTS FDR CHEMICAL DEMETON
S158.120 - PRODUCT CHEMISTRY
Guideline Citation and
Name of Test
Product Identity:
61-1 - Identity of Ingredients
61-3 - Discussion of Formation of
Ingredients
Analysis of Certification of Product
Ingredients
62-1 - Preliminary Analysis
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
Test I/
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Guidelines
Status
R
R
R
R
R
R
R
R
Are Data 2/
Required
Yes No
1*1 f|
I*T 1 T
l*| M
1*1 U
1*1 M

(Xj |X|
1*1 IJ
1*1 M
Footnote
Number






3


         Specific Gravity
                                                              54

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                                                          TABLE A
                                      GENERIC DATA REQUIREMENTS FDR CHEMICAL DEMETON
§158.120 - PRODUCT CHEMISTRY
Guideline Citation and
Name of Test
                                              Test    I/
                                            Substance ~
 Fnysicai ana cnemical Characteristics
 (Continued)


 63-8  - Solubility                       TGAI or PAI

 63-9  - Vapor Pressure                       PAI

 63-10 - Dissociation constant                PAI

 63-11 - Octanol/water partition              PAI
         coefficient

 63-12 - pH                                   TGAI

 63-13 - Stability                            TGAI

 Other Requirements;

  64-1 - Submittal of Samples                 Choice
Guidelines
  Status
Are Data  2/
Required  ~
Yes    No
                                                                                                         Footnote
                                                                                                          Number
   R

   R

   R




   R

   R



   CR
1*1

1*1

I El

1*1


1*1

1*1
 I/  Composition: TGAI = Technical grade of the Active Ingredient;  PAI= Pure active Ingredient.

 2/  Data are due March 1985 for 63-8, 63-9, and 63-11.  All other data are due August, 1985.

 3/  Not required because the technical is a liquid at room temperature.
                                                                55

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                                                        TABLE A
                                     GENERIC DATA RETIREMENTS POP CHEMICAL nEMETTN
Data Requirements
V
Composition
Hoes EPA Have Data
To Satisfy This
Requ i rement? ( Yes ,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
S158.125 Residue Chemistry

  171-4 - Nature of Residue (Metabolism)

        - Plants
   PAIRA
                                                                   Yes
        - Livestock


  171-4 - Residue Analytical  Method

        - Plant residues
PAIRA and plant
 metabolites
NO
TGAI and metabolites   Partially
                 00095640*,00100834,
                 00100836,00100845,
                 00100872,00100898,
                 00100926,00100928,
                 00100930,00100933,
                 00102264,GS0143007,
                 GS0143008,GS0143009,
                 GS0143010,GS014011
                 GS0143016,GS0143011

                 00071233/00071242,
                 00071243,00089855,
                 00095608,00095618,
                 00100829,00100838,
                 00100863,00100864,
                 00100871,00100877,
                 00100883,00100902,
                 00100903,00100904,
                 00100Q12,00100929,
                 00100930,00100934,
                 00100936 ,00100962*,
                 00100964*,00102224,
                 00102232,00102239,
                 00102241,00102260,
                 00105405,GS0143012
                 through GSO143017,
                                                                                                               No
Yes3/
YesV
        - Animal residues
TGAI and metabolites   Reserved^/
                                                               56

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                                                        TABLE A
                                     GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirements
I/
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Sectic
3(c)(2)(B)?2/
§158.125 Residue Chemistry
  (continued)

  171-4 - Storage Stability Data
  171-4 - Magnitude of the Residue-
           Residue Studies for Each
           Food Use

        - Root and tuber Vegetables GroupV

          o Potatoes

            — Crop field trials

            — Processed Food/Feed

          o Sugar Beets

          o Sugar Beets (processed)

        - Leaves of Root and Tuber
           Vegetables Group11-1/

          o Sugar beet tops

        - Leafy Vegetables Group12/

          o Celery

          o Lettuce
PAI
TEP

 EP
Partially
Partially

  No

Partially

  No





Partially



  No

  No
                                      00057268,00100923,
                                      00100831,
                          Yes6/
00100930
                                      00100921,00100943
                                                                Yes8
                                                                Yes9/
                                      00100921,00100^43
                                                                Yes.ll/

                                                                YesW
                                                                  57

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                                                        TABLE A
                                        GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirement
                                                              Does EPA Have Data
                                                              To Satisfy This
                                                     _1/       Requirement?  (Yes,
                                          Composition	No or Partially)
                                                                                     Bibliographic
                                                                                       Citation
                                      Must Additional
                                      Data Be Submitted
                                      Under FIFRA Section
                                       3(c)(2)(B)?2/
§158.125 Residue Chemistry
  (continued)

        - Brassica Leafy Vegetables
           Group1S/

          o Broccoli

          o Brussels sprouts

          o Cabbage

          o Cauliflower

        - Legume Vegetables (Succulent
           or Dried) Group2®/

          o Beans

          o Beans (processed)

          o Peas

        - Foliage of Legume Vegetable
           Group2V

          o Bean vines and hay

          o Pea vines and straw

        - Fruiting Vegetables (Except
           Cucurbi ts) Group2**/

          o Eggplant

          o Peppers
  No

  No

Partially

  No
  NO

  No

  No




  No

  No




  Yes

  No
                                                                                    00095572
                                                                                    00102235
No

Yes"/
                                                                  58

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                                                        TABLE A
                                        GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requirement?  (Yes,
No or Partially)
                                                                                     Bibliographic
                                                                                       Citation
Must Additional
Data Be Submitted
Under FIFRA Section
 3(c)(2)(B)?2/
§158.125 Residue Chemistry
  (continued)

          o Tomatoes

          o Tomatoes (processed)

        - Curcurbit Vegetables Group29/

          o Muskmelons

        - Citrus Fruits Group^1/

          o Grapefruit

          o Lemons

          o Oranges

          o Oranges  (Processed)

        - Pome Fruits Group^-v

          o Apples

          o Apples  (Processed)

          o Pears

        - Stone Fruit

          o Apricots

          o Cherries

          o Nectarines
                         No

                         No



                         No

                         No

                         No

                         No

                       Partially

                         No



                       Partially

                         No

                       Partially



                       Partially

                         No

                         No
                                                Yes28/
                      00100930
                                                YesW
                      00100930
                      00100930
                      00102237
                                                                  59

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                                                        TABLE A
                                        GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirement
           _
Composition
Does EPA Have Data
To Satisfy This
Requirement?  (Yes,
No or Partially) _
§158.125 Residue Chemistry
  (continued)

          o Peaches

          o Plums (fresh prunes)

          o Plums (Processed)

        - Small Fruits and Berries Groupj^/

          o Grapes

          o Grapes (Processed)

          o Strawberry

        - Tree Nuts Group'* "V

          o Almonds

          o Filberts

          o Pecans

          o Walnuts

        - Cereal Grains Group£^/

          o Barley

          o Barley (Processed)

          o Oats

          o Oats (Processed)
     No

     No

     No



     No

     No

     No



     No

     No

     No

   Partially



   Partially

     No

   Partially

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

                                                                    Yes«/
                                          00100930
                                          00100923
                                          00100923
                         NC-5V



                         Ye353/

                         Yes£3/

                         Yes*/
                                                                     60

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                TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirement
V
Composition
Does EPA Have Data
To Satisfy This
Requi rement? ( Yes ,
No or Partially)
Bibliographic-
Citation
Must Additional
Data Be Submitted
Under FIFRA Sectio
3(c)(2)(B)?2/
§158.125 Residue Chemistry
  (continued)

          o Sorghum

          o Sorghum (Processed)

          o Wheat

          o Wheat (Processed)

        - Forage, Fodder, and Straw
           of Cereal Grains Group;*?/

          o Barley forage, hay and straw

          o Oat Forage, hay and straw

          o Sorghum forage, fcoder, silage
             and hay

          o Wheat forage, hay and straw

        - Non-Grass Animal Feeds (Forage,
           fodder, straw, and Hay) Group*^/

          o Alfalfa


          o Alfalfa (Processed)

          o Clover
Partially

  No

Partially

  No
Partially




Partially


  No

Partially
                                            00100937
                                            00100923
Partially
Partially
Partially
00100923
00100923
00100937
                                            00100923
00100931
00100962*

00100962*

00100931
                                                                      YeS55/
                                                                      Yes63/
                          61

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                                                        TABIE A
                                        GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirement
                    Does EPA Have Data
                    To Satisfy This
           I/       Requirement?  (Yes,
Composition	No or Partially)
                                           Bibl iographic
                                             Citation
                   Must Additional
                   Data Be Submitted
                   Under FIFRA Sectior
                    3(c)(2)(B)?2/
§158.125 Residue Chemistry
  (continued)

        - Miscellaneous Commodities

          o Cottonseed

          o Cottonseed (Processed)

          o Hops

          o Hops (Processed)

        - Meat/milk/poultry/eggs


        - Intrastate Uses
                         Yes

                         No

                         No

                         No
00100919
                                                                    No

                                                                    Yes65/
TGAI or plant
 metabolites
00100963*,00100964*
          trefoil, leafy vegetables (including Chinese cabbage, mustard greens^curcubits (including
          oriential squashes, melons, gourds and pumpkins), yard-long beans, Chinese peas, and endive
                                                                   No
                                                                    Yes
                                                               62

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                                                      TABLE A
                                     GENERIC DATA REQUIREMENTS  FOR  CHEMICAL DFMETON


S15B.125 Residue Chemistry
         (continued)

I/ Composition:  TGAI = Technical grade of the active ingredient; PAIRA = Pure active  ingredient, radiolahelled; TEP =
~  Typical end-use product; FP = End-use product.
2/ Data are due March, 1987.
?/ Metabolism studies utilizing ruminants are required.  Animals must be dosed for 3 days with  [32p}ctemeton at a con-
~  centration in the total diet which will result in sufficient residue  in  the tissues and milk  for characterization.
   Animals must be sacrificed within 24 hours of the final dose (milk must  be collected twice daily). 32p_resiclueg must
   be characterized and quantified  in milk, muscle, fat, kidney and liver.  If residues of toxicological concern are
   found to transfer to the tissues and/or milk of ruminants, appropriate tolerances must be proposed,  in addition,
   metabolism studies utilizing poultry are required.  Animals  must be dosed  for 3 days with  [32p]ciemeton at  a
   concentration in the total diet  which will result in sufficient  residue  in the tissues and eggs for characterization.
   Animals must be sacrificed within 24 hours of the final dose (eggs must  be collected twice daily).  32p_residues
   must be characterized and quantified in eggs, muscle, fat, kidney, and liver.  If residues of toxicological concern
   are found to transfer to the tissues and/or eggs of poultry, appropriate tolerances must be proposed.  Also if
   metabolism in poultry differ from that in ruminants additional metabolism of demeton in swine is needed.
4/ A method which can be used for enforcement of residues of demeton is required.  This requirement may be satisfied
"~  by the submission of data which  verify that the use of alternate column  packings (DC-200 vs DFGS)  in the GC
   procedures will provide adequate specificity.  Alternatively, a  validated mass spectrometry method may be  submitted
   for confirmatory purposes.
5/ Although no tolerances for residues in animal products presently exist,  GS method 46795 is adequate for collection
"~  of residue data provided the residues of concern include only the thiol- and thiono-isomers and metabolites III-
   IX.  If the requested animals metabolism data indicate additional residues of concern, then this method will not
   be adequate for data collection.  Furthermore, if tolerances for residues  in animal products are established in
   the future, a decision as to the suitability of this method  for  enforcement purposes will be dependent on  submission
   of additional data regarding its specificity or the availability of an adequate confirmatory procedure.
6/ Data reflecting the frozen storage stability of demeton and  metabolites  III-IX in two plant commodities fortified
~  at levels of each ranging from 0.2 to 12 ppm at intervals of 5-10 months are required.  The additional data
   requested in the various commodity sections should be accompanied by storage interval information and additional
   storage stability data if intervals longer than those requested  above occur.  It should also be noted that the
   acceptability of tolerances for  residues in or on eggplant,  sorghum grain and forage and cottonseed are subject
   to change on receipt of the requested storage stability data.
7/ Residue data are required for two additional members of this crop group  (carrot and radish); currently, demeton
~  formulations are registered for  use only on potatoes and sugar beets.  Additional residue data are required for
   potatoes and sugar beets.
                                                          63

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                                                       TABLE A
                                      GENERIC  DATA REQUIREMENTS FOR CHEMICAL DEMETON

 §158.125 Residua Chemistry
          (continued)

 8/ Data are required reflecting residues in or on potatoes as the result  of foliar application of the 2 or 6 Ib/gal
    EC at 0.5 Ib ai/A beginning when  plants  emerge and  continuing at  10- to  14-day maintenance intervals until 21
    days before harvest;  both ground  and aerial equipment  use  must be represented.  An alternative to submission of
    the above data reflecting multiple applications would  be the establishment of a label restriction limiting the
    number of applications allowed per season  and the submission of data reflecting this restricted number.  Tests
    are to be conducted in CA, ID,  ME, ND [or  MN or WI], and WA.
    Data are required reflecting residues in granules,  chips,  and dried processed potatoes  from potatoes bearing
    detectable weathered residues.
 9/ Data reflecting residues in or on sugar  beet roots  as  the  result  of three foliar applications of the 2 or 6 Ib/gal
    EC at 0.5 Ib ai/A using ground and aerial  equipment are required.  Beets must be harvested 30 days after the final
    treatment.  Tests are to be conducted in CA, ID,  Mi, MN, and NE.
    Data reflecting residues in dehydrated pulp, molasses, and refined sugar processed from sugar beets bearing
    measurable weathered residues are required.
10/ A crop group tolerance is not appropriate  at the present time for the  following reasons:
     (i) Residue data are required for one additional member of this  group (turnip leaves); currently, demeton
         formulations are registered  for use only on sugar beets.
    (ii) Additional residue data are  required  for sugar beets  tops.
11/ Data reflecting residues in or  on sugar  beets tops  as  the  result  of three foliar applications of the 2 or 6 Ib/gal
    EC at 0.5 Ib ai/A using ground and aerial  equipment are required.  Samples must be collected 30 days after the
    last treatment.  Tests are to be  conducted in CA, ID,  MI,  MN, and NE.
12/ Residue data are required for the three  representative members of this crop  group  [celery, lettuce (leaf and head),
    and spinach]; currently, tolerances exist  for residues in  or on celery and lettuce.
13/ Data are required reflecting residues in or on celery  (untrimmed) as the result of foliar application of the 2 or
    6 Ib/gal EC at 0.5 Ib ai/A beginning when  plants emerge  (when infestation is likely to  occur) and continuing at
    10- to 14-day maintenance intervals until  28 days before harvest; treatments must reflect the use of both ground
    and aerial equipment.  An alternative to the submission of the above data reflecting multiple applications would
    be the establishment of a label restriction limiting the number of applications allowed per season and the
    submission of data reflecting that restricted number.  Tests are  to be conducted in CA, FL, and MI.  CA tests must
    include irrigated regions.
14/ Data are required reflecting residues in or on leafy and head (with and  without wrapper leaves) lettuce as the
    result of foliar application of the 2 or 6 Ib/gal EC at 0.5 ai/A  beginning when plants  emerge (when infestation
    is likely to occur)  and continuing at 10-  to 14-day maintenance intervals until 21 days before harvest; treatments
    must reflect the use of both ground and  aerial equipment.  An alternative to the submission of the above data
    reflecting multiple applications  would be  the establishment of a  label restriction limiting the number of
    applications permitted per season and the  submission of data reflecting  that restricted number.  Tests must be
    conducted in AZ, CA,  and FL.  CA  and AZ  tests must  include irrigated regions.
                                                              64

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                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON

 §158.125 Residue Chemistry
          (continued)

15/ Residue data are required for the three representative members of this crop group (broccoli, cabbage and mustard
    greens); currently, tolerances exist for broccoli and cabbage.
16/ Data are required reflecting residues in or on broccoli as the result of foliar application of the 2 or 6 Ib/gal
    EC at 0.5 Ib ai/A using ground and aerial equipment are required.  The first application is to be made in transplant
    water at 0.5 Ib ai/100 gal, and after transplanting, foliar applications are to be made at 10- to 14-day maintenance
    intervals until 21 days before harvest.  Alternative to the submission of the above data reflecting multiple
    applications would be the establishment of a label restriction limiting the number of applications allowed per
    season and the submission of data reflecting that restricted number.  Tests are to be conducted in CA and TX.  CA
    tests msut include irrigated regions.
17/ Sufficient data are not available to assess the adequacy of the established tolerance and label directions;  the
    data submitted were generated with an inadequate cholinesterase-inhibition assay.  However, additional data are
    not required because the data requested for broccoli will be translated to Brussels sprouts.
18/ Data reflecting residues in or on cabbage  (with and without wrapper leaves)  as the result of foliar application
    of the 2 or 6 Ib/gal EC at 0.5 Ib ai/A using ground and aerial equipment are required.  The first application is
    to be made in transplant water at 0.5 Ib ai/100 gal, and after transplanting, foliar applications are to be made
    at 10- to 14-day maintenance intervals until 21 days before harvest.  An alternative to the submission of the
    above data reflecting multiple applications would be the establishment of a label restriction limiting the number
    of applications allowed per season and the submission of data reflecting that restricted number.   Tests are to be
    conducted in CA, FL, NY, and WI.
19/ Sufficient data are not available to assess the adequacy of the established tolerance and label directions;  the
    data submitted were generated with either an inadequate cholinesterase-inhibition, turbidimetric, or biological
    method of analysis.  However, additional data are not required because the data requested for broccoli will be
    translated to cauliflower.
20/ Residue data are required for an additional representative member of this crop group (soybeans);  currently,
    tolerances have been established for beans and peas only.  Additional residue data are required for beans and
    succulent peas.  The following additional residue data are required for dry peas;  data reflecting residues in or
    on dry peas as the result of multiple ground and aerial foliar applications of the 2 or 6 Ib/gal  EC at 0.5 Ib
    ai/A beginning soon after plant emergence and continuing at 10- to 14-day intervals until 21 days prior to
    harvest.  Tests must be conducted in ID and WA.
21/ Data are required reflecting residues in or on beans (one dry and one succulent variety)  as the result of ground
    and aerial foliar application of the 2 or 6 Ib/gal EC at 0.5 Ib ai/A beginning soon after plant emergence and
    continuing at 10- to 14-day maintenance intervals until 21 days before harvest.  An alternative to the submission
    of the above data reflecting multiple applications could be the establishment of a label restriction limiting the
    number of applications allowed per season and the submission of data reflecting that restricted number.  Tests
    are to be conducted in OR, NY, and WI for succulent beans and CA, ID, and ND for dry beans.
                                                               65

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                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FDR CHEMICAL DEMETCN

 $158.125 Residue Chemistry
          (continued)

    Residues must he determined in or on beans hearing measurable weathered residues and in cannery residue processed
    from such beans to determine whether a feed additive tolerance is needed for residues in cannery residue.
    Data are required reflecting residues in or on yard-long beans as the result of multiple foliar applications of
    the 2 Ib/gal EC at 3 lb ai/A fron tests conducted in HTj only one application  is to be made during the first 21
    days of growth followed by additional applications at in- to 14-days of growth followed by additional applications
    at in- to 14-day intervals until 28 days before harvest.
22/ Sufficient data are not available to assess the adequacy of the established tolerance and use directions because
~~*  the data submitted involved an inadequate cholinesterase-inhibition or turbidimetric method of analysis.  No
    additional data are required for dry peas or Chinese peas because upon fulfillment of the data requirement for
    beans, data will be translated to peas.  However, additional data will be required for dry peas in the event that
    a crop group tolerance is sought.  The following additional data are required for succulent peas (seed only):
    data reflecting residues in or on succulent peas (seed only) as the result of group and aerial foliar application
    of the 2 or 6 Ib/gal EC at 0.5 lb ai/A beginning soon after plant emerence and continuing at in- to 14-day
    maintenance intervals until 21 days before harvest.  An alternative to the submission of the above data reflecting
    multiple applications would be the establishment of a label restriction limiting the number of applicaions allowed
    per season and the submission of data reflecting that restricted number.  Tests are to be conducted in MM, OR, or
    m., WL, and DE or NY.
23/ A crop group tolerance is not appropriate at the present time for the following reasons:
     (i) Additional data are required for bean vines and hay.
    (ii) The following additional data are required for pea vines and straw: data reflecting residues in or on pea
         vines at intervals following the last of several foliar applications of the 2 or 6 Ib/gal KC at n.5 lb ai/A
         beginning soon after plant emergence and continuing at in- to 14-day maintenance intervals until 21 days prior
         to harvest (of peas).  Roth aerial and ground application data must be submitted.  Pea straw must be collected
         and analyzed for residues 21 days after the last treatment.  An alternative to submission of the above data
         reflecting an unlimited number of applications would be the establishment of a label restriction limiting
         the number of applications allowed per season and the submission of data reflecting that restricted number.
         Tests are to he conducted in MN, OR or WA, WI, and DE or NY for green peas and in ID and WA for dry peas, and
         data reflecting residues in or on Chinese pea vines immediately after the last of several foliar appli-
         cation of the 2 Ib/gal EC at 2 lb ai/A from tests conducted in HI; only one application is to be made during
         the first 21 days of growth followed by additional applications at in- to 14-day intervals until 28 days
         before harvest (of peas).  Pea straw must be collected and analyzed for residues 28 days after the last
         treatment.
24/ Data are required reflecting residues in or on bean vines at intervals following the last of several foliar
    applications of the 2 or 6 Ib/gal EC at n.5 lb ai/A beginning soon after plant emergence and continuing at. in- to
    14-day maintenance intervals until 21 days prior to harvest (of beans).  Roth aerial and ground application data
    must he submitted.  Bean hay must be collected and analyzed for residues 21 days after the last treatment.  An
    alternative to submission of the above data reflecting an unlimited number of applications would be the establishment

                                                              66

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                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON

 §158.125 Residue Chemistry
          (continued)

    of a label restiction limiting the number of applications allowed per season and the submission of data reflecting
    that restricted number.  Tests are to be conducted in OR, NY, and WI for succulent beans and in CA, ID, MI, NE,
    and ND for dry beans.  Data are required reflecting residues in or on yard-long bean vines immediately after the
    last of several foliar applications of the 2 Ib/gal EC at 3 Ib ai/A from tests conducted in HI; only one applica-
    tion is to be made during the first 21 days of growth followed by additional applications at 10- to 14-day inter-
    vals until 28 days before harvest (of beans).  Bean hay must be collected and analyzed for residues 28 days
    after the last treatment.  Tolerance for residues in or on bean vines and hay and a pregrazing restiction for
    bean vines must be proposed; alternatively, you may propose feeding and grazing restrictions.
25/ Since pea vines and straw are raw agricultural commodities and no feeding or grazing restrictions have been
    established, tolerances or feeding and grazing restictions must be proposed.  No data are required, however,
    because the requested data for bean vines and hay will be translated to peas.  Additional data for pea vines and
    straw will be required if a crop group tolerance is sought.
26/ A crop group tolerance is not appropriate at the present time for the following reason:   residue data are required
    for tomatoes.
27/ Sufficient data are not available to assess the adequacy of the established tolerance and label directions.  An
    inadequate chlolinesterase-inhibition method of analysis was used to generate the data submitted.  However, no
    additional data are required because the requested data for residues in or on tomatoes will be translated to
    peppers.
28 / Data are required reflecting residues in or on tomatoes as the result of ground and aerial foliar application of
    the 2 or 6 Ib/gal EC at 0.375 Ib ai/A beginning when plants are first set out and continuing at 10- to 14-day
    maintenance intervals until 3 days before harvest.  An alternative to submission of the above data involving
    multiple applications would be the establishment of a label restriction limiting the number of applications allowed
    per season and submission of data reflecting that restricted number.  Tests are to be conducted in CA and FL.  CA
    tests must include irrigated regions.
    Data are required reflecting residues in tomato juice, puree, catsup, and wet and dry pomace processed from
    whole tomatoes bearing measurable weathered residues.  If residues are found to concentrate in any of these
    processed products, appropriate food/feed additive tolerances must be proposed.
29/ A crop group tolerance is not appropriate at the present time for the following reasons:
      (i) Residue data are required for two additional members of this group (cucumbers and summer squash [of the
         members in this group, muskmelons are the only one for which a tolerance has been established]).
    (ii) Additional data are required for muskmelons.
30/ Data are required reflecting residues in or on muskmelons after foliar application of the 2 or 6 Ib/gal EC at
    0.375 Ib ai/A using both ground and aerial equipment.  Treatments should begin soon after plant emergence (when
    infestation is likely to occur) and continue at 10- to 14-day maintenance intervals until 21 days before harvest.
    An alternative to the submission of the above data reflecting multiple applications would be the establishment of
    a label restriction limiting the number of applications allowed per season and the submission of data reflecting
    that restricted number.  Tests should be conducted in AZ, CA, and TX.  CA and AZ test sites must include irrigated
    regions.
                                                               67

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                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON

 §158.125 Residue Chemistry
          (continued)

31/ A crop group tolerance is not appropriate at the present time for the following reasons:
     (i)  Additional residue data are required for sweet oranges.
    (ii)  The following additional residue data are required for both lemon and grapefruit:   data reflecting residues
         in or on lemons and grapefruit from foliar application of the 2 or 6 Ib/gal EC at 2.5 Ib ai/A beginning in
         early spring  (when infestation is likely to occur)  and continuing at 10- to 14-day maintenance intervals
         until 21 days before harvest; treatments must involve both ground and aerial equipment use.   An alternative
         to the submission of the above data reflecting multiple applications would be the establishment of a label
         restriction limiting the number of applications allowed per season and the submission of data reflecting
         that restricted number.  Tests are to be conducted in AZ and CA for lemons and in CA, FL,  and TX for
         grapefruit.
32/ Sufficient data are not available to assess the adequacy of the established tolerance and label directions because
    the data submitted were generated with an inadequate cholinesterase-inhibition assay.  However, additional data
    are not required because upon fulfillment of the data requirements for oranges, data will be transferred to
    grapefruit.  In the event that a crop group tolerance is sought, additional data for grapefruit will be required.
33/ Sufficient data are not available to assess the adequacy of the established tolerance and label directions because
    the data submitted were generated with an inadequate cholinesterase-inhibition assay.  However, additional data
    are not required because upon fulfillment of the data requirements for oranges, data will be transferred to
    lemons.  In the event that a crop group tolerance is sought, additional data will be required for lemons.
34/ Data are required  reflecting residues in or on oranges (sweet and sour varieties)  from foliar application of the
    2 or 6 Ib/gal EC at 2.5 Ib ai/A beginning in early spring  (when infestation is likely to occur) and continuing at
    10- to 14-day maintenance intervals until 21 day before harvest; treatments must involve both ground and aerial
    equipment use.  An alternative to the submission of the above data reflecting multiple application would be the
    establishment of a label restriction limiting the number of applications allowed per season and the submission of
    data reflecting that restricted number.  Tests are to be conducted in FL and CA.
    Data are required  reflecting residues in dried pulp, peel, oil, molassess, and juice processed from oranges
    bearing measurable weathered residues.
35/ A crop group tolerance is not appropriate at the present time for the following reasons:
     (i)  Data requirements for apples must be fulfilled.
    (ii)  Residue data  must be submitted for pears harvested 21 days after the last of three foliar applications of
         an EC formulation at 0.25 Ib ai/100 gal  (2.25 Ib ai/A).  The data should reflect ground and aerial applica-
         tions.  The tests should be conducted in CA, WA and NY.
36/ Residue data from apples harvested 21 days after the last of three foliar applications of an EC formulation at
    0.25 Ib ai/100 gal (3 Ib ai/A/application), and in separate tests, 21 days after a single foliar  application at
    0.5 Ib ai/100 gal  (6 Ib ai/A/application) are required.  The data should reflect aerial and ground applications.
    Tests should be conducted in WA, NY, MI and CA.
    Residue data are required from processed apple products (wet pomace, dry pomace and juice) produced from field-
    treate bearing detectable, weathered residues.  Exaggerated application rates may be necessary to obtain such
    residues.   If residues concentrate in any of these processed products,  appropriate food/feed additive tolerances
    must be proposed.
                                                                68

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                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON

 §158.125 Residue Chemistry
          (continued)

37/ The submitted data do not provide adequate support for the established tolerance for demeton residues in or on
    pears for the following reasons:  (i) the data do not reflect potential residues in pears treated at the maximum
    rate; (ii)  no registered formulation was tested; (iii) no aerial application data were submitted; and (iv)  a
    portion of the data were generated with inadequate analytical methods.  However, no additional data are required
    because we will translate the requested data for apples to pears.  If a crop group tolerance is proposed, additional
    data for residues in pears must be submitted.
38/ A crop group tolerance is not appropriate at the present time for the following reason:  data requirements for
    peaches, plums and cherries  (the representative crops) must be fulfilled.
39/ The available data do not adequately support the established tolerance for demeton residues in or on apricots.
    However, no additional data are required because the data requested for peaches will be used to further evaluate
    the tolerance for residues in or on apricots.
40/ The available data are not adequate to support the established non-food-use status of cherries treated in nonbearing
    years.  The following data are required:
    Residue data from cherries harvested from trees treated several times at 0.5 Ib ai/100 gal with an EC formulation
    in the season previous to that in which the samples are harvested.  If detectable residues are found, a tolerance
    must be proposed.
41/ No data were submitted for nectarines.  Furthermore, the available, translatable data (for apricots and peaches)
    are not adequate to support the established tolerance for demeton residues in or on nectarines.  However, no
    additional data are required because the data requested for peaches will be used to further evaluate the nectarine
    tolerance.
42/ Residue data are required from peaches harvested 30 days after the last of three applications of an EC formulation
    at 0.25 Ib ai/100 gal  (800 gal/A), made by aerial and ground equipment.  The tests should be conducted in CA and SC.
43/ Residue data are required from plums harvested 60 days after the last of two applications of an EC formulation at
    0.375 Ib ai/100 gal  (800 gal/A), and in separate tests, 30 days after the last of three applications at 0.25 Ib
    ai/100 gal (800 gal/A), made using ground or aerial equipment.  Tests should be conducted in OR and MI.
    Residue data are required from dried plums  (prunes) , processed from fieldtreated plums bearing detectable,
    weathered residues.  The use of exaggerated rates may be required to obtain such residue levels.  If residues
    concentrate in dried prunes, an appropriate food additive tolerance must be proposed.
44/ A crop group tolerance is not appropriate at the present time for the following reasons:
      (i) Residue data are required for additional representative members of this crop group  {blackberry, blueberry and
         cranberry); currently, tolerances exist only for grapes and strawberries.
    (ii) Additional residue data are required for grapes and strawberries.
45/ Data are required reflecting residues in or on grapes as the result of foliar application of the 2 or 6 Ib/gal EC
    at 0.375 Ib ai/A beginning in early spring  (when infestation is likely to occur) and continuing at 10- to 14-day
    maintenance intervals until 21 days before harvest; treatments must involve both ground and aerial equipment use.
    An alternative to the submission of the above data reflecting multiple applications would be the establishment of
    a label restriction limiting the number of applications allowed per season and the submission of data reflecting
    that restricted number.  Tests are to be conducted  in CA.
                                                              69

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                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON

 §158.125 Residue Chemistry
          (continued)

    Data reflecting demeton residues in raisins, juice, wet and dry pomace, and raisin waste processed from grapes
    bearing detectable weathered residues are required.
46/ Data are required reflecting residues in or on strawberries as the result of foliar application of the 2 or 6
    Ib/gal EC at 0.375 Ib ai/A beginning in spring (when infestation is likely to occur) and continuing at 10- to 14-
    day maintenance intervals until 21 days before harvest; treatments must include both ground and aerial equipment
    use.  An alternative to the submission of the above data reflecting multiple applications would be the establishment
    of a label restriction limiting the number of applications allowed per season and the submission of data reflecting
    that restricted number.  Tests are to be conducted in CA, FL, and OR.
47/ A crop group tolerance is not appropriate at the present time for the following reason:   additional data are
    required for almonds, fiberts and pecans.  [Since no additional residue data have been requested for the repre-
    sentative commodity, English walnuts (data will be translated from almonds), filberts may substitute for English
    walnuts as a representative commodity for tree nuts.]
48/ Data are required reflecting residues in or on almonds and almond hulls harvested 21 days after a single foliar
    application of the 2 or 6 Ib/gal EC at 0.75 Ib ai/A; both ground and aerial application data must be submitted.
    Tests must be conducted in CA.
49/ Data are required reflecting residues in or on filberts as the result of foliar application of the 2 or 6 Ib/gal
    EC at 2.5 Ib ai/A beginning in spring (when infestation is likely to occur)  and continuing at 10- to 14-day
    maintenance intervals until 40 days before harvest; treatments must include both ground and aerial equipment use.
    An alternative to the submission of the above data reflecting multiple applications would be the establishment of
    a label restriction limiting the number of applications allowed per season and the submission of data reflecting
    that restricted number.  Tests should be conducted in OR.
50/ Data are required reflecting residues in or on pecans as the result of foliar application of the 2 or 6 Ib/gal EC
    at 1 Ib ai/A beginning in spring (when infestation is likely to occur) and continuing at 10- to 14-day maintenance
    intervals until 21 days before harvest;  treatment must involve ground and aerial equipment.  An alternative to
    the submission of the above data reflecting multiple applications would be the establishment of a label restriction
    limiting the number of applications allowed per season and the submission of data reflecting that restricted
    number.  Tests should be conducted in AL, GA, and LA.
51/ Additional data are not required,  because the requested data for almonds will be translated to walnuts to assess
    the adequacy of the established tolerance.
52/ A crop group tolerance is not appropriate at the present time for the following reasons:
     (i) Residue data are required for two additional representative members of this group [corn (field and sweet) and
         rice.]; currently tolerances  exist for residues in or on the grain of barley, oats, sorghum, and wheat.
    (ii) Additional residue data are required for the grain of oats.
53/ Data are required reflecting residues in germ processed from barley grain bearing measurable weathered residues.
    If residues concentrate in this processed product, an appropriate food additive tolerance must be proposed.
                                                               70

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                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON

 §158.125 Residue Chemistry
          (continued)

54/ Sufficient data are not available to assess the adequacy of the established tolerance because:  (i) no data reflect
    the registered use on crops grown for seed, and (ii) no data were submitted regarding possible concentration of
    residues in milling products.  Despite the established label restrictions, crops grown for seed may be diverted
    for human or animal consumption.  In addition, since hulls are a raw agricultural commodity of oats, residue data
    must be submitted and an appropriate tolerance must be proposed.  The following data are required:
     (i) Data are required reflecting residues in or on oat grain and hulls as the result of foliar ground and aerial
         applications of the 2 or 6 Ib/gal EC formulations at 0.25 Ib ai/A beginning in the spring (when infestation is
         most likely to occur) and continuing at 10- to 14-day intervals until harvest.  Samples must be collected
         immediately after the last treatment.  Tests must be conducted in IA, MN, NY, SD, and TX.
    (ii) Data are required reflecting residues in the milled products processed from oats bearing measurable weathered
         residues.  If residues are found to concentrate in any of the milled products of oats, an appropriate food
         additive tolerance must be proposed.
55/ The available data provide adequate support for the established tolerance covering residues of demeton in or on
    the grain of sorghum.  However, the following additional data are required to determine whether separate food
    additive tolerances are needed for flour and milled products:
    Data reflecting residues in flour and milled products from grain bearing measurable weathered residues.  It may
    be necessary to treat at exaggerated rates to obtain detectable residues in grain.  If residues concentrate during
    processing, appropriate food additive tolerances must be proposed.
56/ Sufficient data are not available to assess the adequacy of the established tolerance because:  (i) no data reflect
    the registered use on crops grown for seed, and (ii) no data were submitted regarding possible concentration of
    residues in milling products.  Despite the established label restrictions, crops grown for seed may be diverted
    for human or animal consumption.  No additional data for wheat are required, however, because the requested data
    for oats will be translated to wheat.
57 / Residue data are required for an additional representative member of this group (corn); currently tolerances
    exist for barley, oats, sorghum, and wheat.  Additional residue data are required for oats.  Additional residue
    data and tolerance proposals or feeding restrictions are needed for the fodder, silage and hay of sorghum.
58/ Sufficient data are not available regarding residues of demeton in or on the forage, fodder and straw of small
    grains, including barley for the following reasons:  (i) geographic representation was inadequate for forage and
    hay; (ii) only one hay sample, from a CA test, was submitted; (iii) the means of application (ground or aerial)
    was unspecified; and (iv) no data were submitted reflecting the registered use on crops grown for seed.  In our
    opinion, despite the label restriction, crops grown for seed may be diverted for animal consumption.  The necessary
    data for tolerance evaluation will be translated from the data which has been requested for oats: thus no additional
    data for barley are required.  It should be noted that hay is a raw agricultural commodity of small grains;
    therefore a tolerance for residues in or on hay must be proposed.  Furthermore, the commodity definition of "green
    fodder" should be changed to "forage."



                                                               71

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                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FDR CHEMICAL DEMETCN

 3158.125 Residue Chemistry
          (continued)

59/ Data are required reflecting residues in or on the straw, forage, and hay of oats treated several times with an
~~~  EC formulation at 0.25 lb ai/A/application.  Both aerial and ground application data must he submitted.  Treatments
    must begin in the spring (when infestation is likely to occur) and continue at 10- to 14-day maintenance intervals
    thereafter.  Samples must be collected immediately following the last treatment.  Tests must be conducted  in SD,
    IA, MM, ND, and WI.  It should be noted that hay is a raw agricultural commodity of small grains; therefore a
    tolerance for residues in or on hay must be proposed.  Furthermore, the commodity definition of "green fodder"
    should be changed for "forage."
60/ The available data provide adequate support for the established tolerance covering residues of demeton in or on
""""  the forage of sorghum, however, since fodder, silage and hay are raw agricultural commodities of sorghum,  feeding
    restrictions or the following residue data (accompanied by appropriate tolerance proposals) are required:
    Data reflecting residues in or on fodder, silage, and hay harvested 35 days after a single foliar application of
    an EC formulation at 0.25 lb ai/A.  Both ground and aerial application data must be submitted.  Tests must he
    conducted in KS and TX.
61/ Sufficient data are not available regarding residues of demeton in or on the forage, fodder and straw of small
    grains, including wheat for the following reasons:  (i) geographic representation was inadequate for forage and
    hay; (ii) only one hay sample, from a CA test, was submitted:  (iii) the means of application (ground or aerial)
    was unspecified; and (iv) no data were submitted reflecting the registered use on crops grown for seed.
    Despite the label restriction, crops grown for seed may he diverted for animal consumption.  The necessary
    data for tolerance evaluation will be translated from the data which has been requested for oats; thus no  additional
    data for wheat are required.  It should be noted that hay is a raw agricultural commodity of small grains; therefore
    a tolerance for residues in or on hay must be proposed.  Furthermore, the commodity definition of "green fodder"
    should be changed to "forage."
62/ A crop group tolerance is not appropriate at the present time for the following reasons:
     (i) Additional residue data are required for alfalfa.
    (ii) The following additional residue data are required for clover: data reflecting residues in or on clover forage
         an hay as the result of several ground and aerial foliar applications, beginning in the spring when infestation
         is likely to occur and continuing at in- to 14-day intervals thereafter, of the 2 or 6 Ib/gal EC at 0.5 lb
         ai/A from tests conducted in MO, NY, OH, PA, and WI; samples of hay are to be harvested 15 days after treat-
         ment.  Forage must be collected immediately after the last treatment and at intervals thereafter; alterna-
         tively, a 15-day pregrazing interval on crops grown for seed may be proposed and data submitted for foliage
         collected 15 days after the last treatment, as above.
63/ Sufficient data are not available to assess the adequacy of the established tolerances for the following reasons:
    (i) no data reflect the registered use on crops grown for seed; despite the label restriction, these crops may he
    diverted for livestock feed; (ii) several tolerance-exceeding  residue values were reported for green forage
    harvested >21 days following the registered use on crops grown for feed; (iii) the method of application was
    unspecified; and (iv) no information as to the presence or absence of detectable levels of metabolites V-VII was



                                                           72

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                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON

 §158.125 Residue Chemistry
          (continued)

    given.   In  addition,  no data were submitted pertaining to potential concentration of residues in alfalfa meal or
    to residues in the raw agricultural commodity, seed.  A tolerance for residues in or on seed must be proposed.
    The following data are required:
      (i)  Data  reflecting residues (demeton plus metabolites III-IX)  in or on hay and seed of alfalfa 15 days after
          the last of  several foliar  applications (beginning in the spring when infestation is likely to occur and con-
          tinuing at 10- to 14-day maintenance intervals thereafter)  of an EC formulation at 0.5 Ib ai/A.  Forage must
          also  be collected immediately after the last treatment and at intervals thereafter; alternatively, a 15-day
          pregrazing interval on crops grown for seed may be proposed and data submitted for foliage collected 15 days
          after the last treatment, as above.  Data reflecting the use of both ground and aerial application equipment
          must  be submitted.  Tests must be conducted in CA, IA,  MN,  NE,  and SD.
     (ii) Data  reflecting residues in or on meal processed from alfalfa bearing measurable weathered residues.  If
          residue concentrate during  meal production, a feed additive tolerance must be proposed.
    (iii) It should be noted that the commodity definition "fresh alfalfa" should be changed to "alfalfa forage."
64/ No data are available to assess the adequacy of the established tolerances and label directions.  However, no
    data are required because upon fulfillment of the data requirements for alfalfa forage and hay, data will be
    transferred to clover.  However,  in the event that a crop group tolerance is  desired,  residue data for clover
    will be required.   The current tolerance expression for "fresh clover" should be changed to "clover  forage,"
    which more  appropriately describes this raw agricultural commodity.
65/ The submitted data support the established tolerance for the residues of demeton in or on cottonseed.  The data
    do not, however, show if residues will concentrate upon processing cottonseed into processed products.  The
    following data are required to determine if processed products require feed/food additive toierar.es:
     (i)  Residue data  from meal, hulls, soapstock, crude oil and refined  oil produced from field-treated cottonseed
         bearing measurable, weathered residues.  Exaggerated rates may be required to obtain detectable residue levels.
    (ii)  If a concentration factor greater than one is determined for any of the  processed commodities,  an appropriate
         food/feed additive tolerance should be proposed.
66/ The available data are not adequate to support the established tolerance for  demeton residues in or  on hops; all
    submitted data were generated with unacceptable cholinesterase-inhibition assay methods.  The following data are
    required:
     (i)  Residue data  from mature hops harvested 21 days after the last of several foliar  applications,  beginning in the
         spring when infestation is likely to occur and continuing at 10- to 14-day intervals thereafter, with an EC
         formulation at 0.5 Ib ai/A.   The tests should include aerial and ground  applications and should be conducted in
         WA.
    (ii)  Residue data  from dried hops and spent hops produced from field-treated  hops bearing detectable, weathered
         residues.  Exaggerated application rates may be required to obtain detectable residues levels.   If residues
         concentrate in either of these processed products, appropriate food/feed additive tolerances must be proposed.
                                                              73

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                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON

 §158.125 Residue Chemistry
          (continued)

67/ There are no direct animal treatments for demeton on cattle,  goats,  hogs,  horses or  sheep.   The  maximum expected
    dietary intake of demeton residues by dairy or beef cattle is 6.8 ppm if the diet included  40% small grains,
    10% sugar beet pulp, and 50% alfalfa or clover hay.  The maximum expected  intake by  poultry is 0.775 ppm,  based
    on a diet of 95% grains (<50% barley, <25% oats,  <60% sorghum,  <73%  wheat)  and 5% dried grape pomace.   For swine,
    a reasonable diet, containing 50% grains (<50% oats, wheat or barley),  10%  clover forage,  15% dehydrated sugar
    beet pulp, and 25% potatoes, would contain up to  1.81 ppm demeton residues.
    A decision as to the adequacy of the available data regarding magnitude of  residues  in animals cannot be made at
    the present time because the nature of the residue in animals has not been elucidated.  On  receipt of the requested
    animal metabolism data, the adequacy of the available data will be determined.

 *  Data submitted by Mobay Chemical Corp. Data may be compensable.
                                                               74

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                                                      TABLE A
                                   GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
I/
Data Requirement Composition
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis TGAI or PAIRA
Photodegradat ion
161-2 - In water TGAI or PAIRA
161-3 - On soil TGAI or PAIRA
161-4 - In Air TGAI or PAIRA
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil TGAI or PAIRA
162-2 - Anaerobic Soil TGAI or PAIRA
162-3 - Anaerobic Aguatic TGAI or PAIRA
162-4 - Aerobic Aquatic TGAI or PAIRA
MOBILITY STUDIES:
163-1 - Leaching and TGAI or PAIRA
Adsorpt ion/Desorpt ion
163-2 - Volatility (Lab) TEP
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Pattern" No or Partially) Citation 3(c)(2) (B)?3/
A,B,F,G No
A,B,G No
A,B,G NO
A,B No
A,B,F,G No
A,B No
G No
Not Applicable
A,B,F,G No
A,B,F NO
Yes
Yes
Yes
Yes
Yes
YesV
Yes
Yes
Yes
163-3 - Volatility (Field)
TEP
A,B,F            ReservedV
                                                               75

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                   TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
I/
Data Requirement Composition
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis TGAI or PAIRA
Photodegradat ion
161-2 - In water TGAI or PAIRA
161-3 - On soil TGAI or PAIRA
161-4 - In Air TGAI or PAIRA
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil TGAI or PAIRA
162-2 - Anaerobic Soil TGAI or PAIRA
162-3 - Anaerobic Aquatic TGAI or PAIRA
162-4 - Aerobic Aquatic TGAI or PAIRA
MOBILITY STUDIES:
163-1 - Leaching and TGAI or PAIRA
Adsorpt ion/Desorpt ion
163-2 - Volatility (Lab) TEP
163-3 - Volatility (Field) TEP
	 Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Pattern" No or Partially) Citation 3(c) (2) (B)?3/
A,B,F,G
A,B,G
A,B,G
A,B
A,B,F,G
A,B
G
Not Applicable
A,B,F,G
A,B,F
A,B,F
No
No
NO
No
No
No
No
No
No
ReservedV
Yes
Yes
Yes
Yes
Yes
YesV
Yes
Yes
Yes

                          76

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                                                        TABLE A
                                        GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
                                                           Does EPA Save Data""
                                                           To Satisfy This
                                            I/   Use  2/   Requirement?  (Yes,
                                 Composition"  Pattern"    No or Partially)
                                                                  Must Additional
                                                                  Data Be Submitted
                                                                  Under  FIFRA Section
                                                                   3(c)(2)(B)?3/
Data Requirement
Bibliographic
  Citation
§158.130 Environmental Fate
         Tcontinuen)

  DISSIPATION STUDIES-FIELD;

  164-1 - Soil

  164-2 - Aquatic (Sediment)
  164-3 - Forestry

  164-4 - Combination and
           Tank Mixes

  164-5 - Soil, Long-term

  ACCUMULATION STUDIES;

  165-1 - Rotational Crops
           (Confined)

  165-2 - Rotational Crops
           (Field)

  165-3 - Irrigated Crops
   165-4 - In Fish

   165-5 - In Aquatic Non-Target
           Organisms
    TEP

    TEP
                                                 A,B            No

                                                 Not Applicable
                               No

                               No
                                     TEP         G




                                     TEP         A,B            Reserved?/



                                    PAIRA        A,B            No


                                     TEP         A,B            No


                                     TEP         Not Applicable
TGAI or PAIRA   A,B,G

    TEP         G
                                                                No

                                                                Reserved8/
                                                                         Yes
                         Yes

                         NoV
                                                                         Yes
                                                                         Yes
                                                                                                           Yes
                                                              77

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                                                         TABLE A
                                         GENERIC DATA REQUIREMENTS FDR CHEMICAL DEMETON
                                                            Does EPA Have Data                       Must Additional
                                                            To Satisfy This                          Data Be Submitted
                                             I/   Use  2/   Requirement?  (Yes,    Bibliographic     Under FIFRA Section
 Data Requirement	Composition"  Pattern"    No or Partially)	Citation	3(c)(2)(B)?3/	

 S158.130 Environmental Fate
          (continued)

I/  Composition:  TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled,
""   TEP=Typical end-use product.
2/  The use patterns are coded as follows:  A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, Food Crop,
""   D * Aquatic, Non-Food; G = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor;
    I = Indoor.
3/  Data are due March, 1985 for 161-1, 161-2, 161-3 and 163-1;  August, 1985 for 161-4 and 163-2; June, 1986 for 162-1,
~   162-3, and 164-1; March, 1987 for 164-3 and 165-1; and March, 1988 for 165-2.
4/  Data from an anaerobic soil metabolism study need not be submitted if data from an anaerobic aquatic metabolism
*"   study are submitted.
5/  May be required, depending on results of 163-2 (Lab volatility).
£/  Not required because this standard only deals with single active ingredient products.
7/  May be required depending on results from 164-1 (Terrestrial [Soil] Field Dissipation) and 162-1 (Aerobic
""   Soil metabolism).
8/  May be required depending on results from 165-4 (Fish Accumulation Study).
                                                                  78

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                                                        TABLR A
                                       GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Data Requirement Composition" Patterns" No or Partially)
5158.135 Toxicology
ACUTE TESTING:
81-1 - Acute Oral Toxicity - Rat TGAI A,B,F,G Yes
81-2 - Acute Dermal Toxicity 1GAI A,R,F,G Yes
- Rabbit
81-3 - Acute Inhalation Toxicity TGAI A,B,F,G No
- Rat
81-6 - Dermal Sensitization - A,R,F,G No
Guinea Pig
81-7 - Delayed TGAI A,B,F,G Partiallyll/
Neurotoxicity - Hen
SUBCHRONIC TESTING
82-1 - 90-Day Feeding -
Rodent, Non- rodent TGAI A,F No
82-2 - 21-Day Dermal - Rabbit TGAI A,B,F,G No
82-3 - 90-Day Dermal - Rabbit TCAI A,B,F,G No
82-4 - 90-Day inhalation - A,B,F,G No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c) (2) (B)?3/


05002272 No
05002272 No

Yes

NoV

00052735 Yes


Yes5/
Yes
No
No
        Rat

82-5 - 90-Day Neurotoxicity-
        Hen/Mammal
TCAI
A,B,F,G
Partially6/H/
                                                 GS0143019
                                                        Reserved
                                                            79

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                                                        TABLE A
                                        GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETCN
Data Requirement
           I/   Use
Composition"  Pattern
          Does EPA Have Data
          To Satisfy This
          Requirement?  (Yes,
          No or Partially)
                   Bibliographic
                     Citation
                 Must Additional
                 Data Be Submitted
                 Under FIFRA Section
                   3(C)(2)(B)?2/
S158.135 Toxicology
         (continued)

  CHRONIC TESTING;

  83-1 - Chronic Toxicity -
          2 species:  Rodent
          and Non-rodent

  83-2 - Oncogenicity -
          2 species:  Rat and
          Mouse preferred

  83-3 - Teratogenicity -
          2 species

  83-4 - Reproduction - Rat
          2-generation

  MUTAGENICITY TESTING

  84-2 - Gene Mutation

  84-2 - Chromosomal Aberration

  84-2 - Other Mechanisms of
          Mutagenicity

  SPECIAL TESTING

  85-1 - General Metabolism

  85-2 - Domestic Animal Safety

  82-1 - 90-Day feeding - Rat
   TGAI



   TGAI



   TGAI


   TGAI




   TGAI

   TGAI

   TGAI
A,F,
A,B,F,G
A,B,F,G
A,B,F,G
PAI or PAIRA    A,B,F,G

   Choice       A,B,G

Thiol sulfoxide A,B,F,G
 (metabolite)
No
No
Partiallyll/
No
A,B,F,G       Partially

A,B,F,G       Partially

A,B,F,G       Yes
              Partially

              Not Required

              No
GS0143018
                     00028625
YesV



YesV



Yes**/


Yes"7/
                         Yesl2/
                     GS0143001, GS0143002
                               (supplementary)
                     00028625                 No
                     00100927(mouse study)    Yes9/
                                              YesW
                                                             80

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                                                            TABLE A
                                                            TABLE A
                                             GENERIC DATA REQUIREMENTS FOR DEMETON
                                                            Does EPA Have Data                       Must Additional
                                                            To Satisfy This                          Data Be Submitted
                                             _!/   Use  2/   Requirement?  (Yes,    Bibliographic     Under FIFRA Section
 Data Requirement	Composition   Pattern	No or Partially)	Citation	3(c)(2) (B)?V	

 §158.130 Toxicology
          (continued)

 I/  Composition:  TGAI = Technical grade of the active ingredient.
 2/  The use patterns are coded as follows:  A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
     D=Aquatic, Non-Food; E=<3reenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Dcmestic Outdoor; Indoor
 _3/  Data are due March,  1985 for 83-1; data are due August, 1985 for 81-3,  81-7, 82-2  and 84-2; data are due
     December, 1987 for 83-2 and 83-4; data are due March, 1986 for 85-1; and data are due December, 1985 for 83-3.
     For 82-1, data are due June, 1986 for the 90-day feeding rodent, non-rodent, and January, 1986 for the 90-day
     feeding rat- thiol sulfoxide study.
 4/  Due to the extreme acute dermal toxicity, a dermal sensitization study is not required on the technical material.
 j>/  An additional 90-day rat feeding study (82-1) is required on demeton thiolphosphate sulfoxide.
 6/  This study is reserved pending the results of 81-7.
 7/  Data for 83-1, 83-2, and 83-4 may be fulfilled by citing data on disulfoton. The Agency is allowing the data to be
     bridged on the basis of chemical structural similarities.
 8/  A teratogenicity study is required in each of two species.
 _9/  An additional general metabolism study in the rat is required.
10/  A 90-day feeding study in the rat with emphasis on determination of ChE inhibition is required to assist
     determination of the ADI.
ll/  Studies are considered supplementary.
12/  A gene mutation assay in mammalian cells in culture is required.
13/  A chromosome aberration assay in vivo is required.
                                                                81

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                                                        TABLE A
                                        GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
                                                           Does EPA Have Data                       Must Additional
                                                           To Satisfy This                          Data Be Submitted
                                            I/        2/   Requirement?  (Yes,    Bibliographic     Under FIFRA Section
Data Requirement	Composition"  Pattern"    No or Partially)         Citation         3(c)(2)(B)?V
SI58.140  Reentry Protection

  132-1 - Foliar Dissipation         TEP        A,B,G            No                                      YesVV

  132-1 - Soil Dissipation           TEP        A,B,G            No                                      YesVV

  133-3 - Dermal Exposure            TEP        A,B,G            No

  133-4 - Inhalation Exposure        TEP        A,B,G            No
I/ Conposition: TEP = Typical end-use product.
7/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, Food Crop;
~  D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor;
   I = Indoor.
3/ Data are due March, 1<»88.
37 An interim reentry interval of 48 hours is in effect until data are received and evaluated.
=>/ Further information on these data requirements and a discussion of appropriate methodology are contained in Subdivision
~  K of the Pesticide Assessment Guidelines.  That document is available (50 FR 159, January 2, 1985) and can be purchased
   through NTIS.  Orders for Subdivision K may be placed on telephone (703-487-4650), to the NTIS order desk.  The document
   number is PB-85-120962, and the prices are SlO.OO for the hardcopy and S4.50 for the microfiche copy.
                                                              82

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                                                        TABLE A
                                       GBNERIC DATA REQUIREMENTS FOR CHEMICAL DEMETTN
Data Requirement
                          Does EPA Have Data"
                          To Satisfy This
           V   Use  2/   Requirement?  (Yes,
Composition"  Pattern"    No or Partially)
S158.145 Wildlife and
  Aquatic Organisms

  AVIAN AND MAMMALIAN TESTING

  70-1 - Special test                TEP

  71-1 - Acute Avian Oral Toxicity   TGAI

  71-2 - Avian Rubacute Dietary      TGAI
           Toxicity

  71-3 - Wild Mammal Toxicity        TGAI

  71-4 - Avian Reproduction          TGAI
  71-5 - Simulated and Actual        TEP
          Field Testing -
          Mammals and Birds

  AQUATIC ORGANISM TESTING

  70-1 - Special test                TEP

  72-1 - Freshwater Fish Acute
          Toxicity

                 Warm water          TGAI
                Not Applicable

                A,B
                                 Partially
                A,B,F 5/.G
                                 No
Yes
                Bibliographic
                  Citation
               Must Additional
               Data Be Submitted
               Under FIFRA Section
                3(c)(2)(B)?3/
A
A,B,G
A,B,F5/ fi/fG
NO
Yes
Yes

05000975
00022923
                   00100956*,00100958*
                   00100957*,00102259*
                        Yesf/

                        No

                        No




                        Reserved7/


                        Reserved7/,
                                           YesV
GS0143006,00013531
00035796,00112132
00060630*
                                           No
                                                              83

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                                                      TABLE A
                                     GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
I/
Data Requirement Composition
TEP
Cold water TGAI
TEP
Use 2/
Pattern"
A
A,R,G
A
noes EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Partially
Yes
Partially
Bibliographic
Citation 12/
00090378, GS0143003
Gsni43nofi
nn09031R,GS0143004
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/ 12/
Reserved?/
NO
Reserved 7/
72-2 - Acute Toxicity to
        Freshwater Invertebrates   TGAI        A,B,F5/fG

72-3 - Acute Toxicity to Estuarine
        and Marine Organisms

        Fiddler crab

        Oyster-

        Shrimp

        Estuarine fish

72-4 - Fish Early Life
       Stage and Aquatic
       Invertebrate Life-Cycle

72-5 - Fish - Life-Cycle

72-fi - Aquatic Organism
        Accumulation
72-7 - Simulated or Actual
       Field Testing -
       Aquatic Organisms           TEP         A,B
TGAI
TEP
TEP
TEP
TEP
TGAI
TGAI
A
A
A
A
A
A,B
A,B
TGAI , PA1 or
Degradation
Product
Yes
 No
                                                                               GS0143005
GS0143Dr)6
 PartiallylI/   00100960*
                                        No
                     Reserved?/

                     Reserved?/

                     Reserved?/

                     Reserved"?/



                     Reserved?/

                     Reserved?/


                     Reserved 7/
                                     ReservedI/
                                                              84

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                                                        TABLE A
                                       GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirement
           I/   Use  2/
Composition   Pattern
Does EPA Have Data""
To Satisfy This
Requ i rement?  (Yes,
No or Partially)
Bibliographic
  Citation
Must Additional
Data Be Submitted
Under FIFRA Section
 3(c)(2)(B)?3/
  I/  Composition:  TGAI = Technical grade of the active ingredient; PAI = pure active ingredient;  TEP = Typical end-use
      product
  2/  Th<3 use patterns are coded as follows:  A = Terrestrial, Food Crop;  R = Terrestrial, Non-Food Crop; C = Aquatic,
      Food Crop; D = Aquatic, Non-Food; E = C-reenhouse, Food Crop; F = Greenhouse, Non-Food;  G = Forestry; H - Domestic
      Outdoor I = Indoor.
  3/  Data are due September, 1986.
  4/  Monitoring of residues on avian feed items in an apple orchard when treated at 5.o to 6.0 Ib. ai/A is required.
  5/  Study is required to support the manufacturing-use product to be reformulated into the end-use product.
  6/  Only one species must be tested.
  7/  Study may be required pending receipt of environmental fate data.
  8/  Studies in apples do not fulfill requirement.  Studies in alfalfa are not required.
  9/  Monitoring of residues in aquatic sites adjacent to grove orchards when treated at 2.0  to 6.0 Ih. ai/A
      are required.
 in/  Data are required for such crops as citrus, cotton, sorghum where 300,000 acres are  grown in  coastal counties.
 ll/  Fiddler crab is not a recommended species.
 12/  Citations 05000975, 00022923, 00100956, 00100958, GS0143006, GSOJ43003, GS0143006, GS0143004, GS0143005, and
      GS0143006 each stand alone to fulfill data requirement.  Citations 00100957, 00102259,  00013531, 00035796,
      00112132, 00060630, 00090378 and 00090318 must be cited with an additional study to  fulfill data requirement.

 *    Data submitted by Mobay Chemical Corp.  Data may be compensable.
                                                                 85

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                                                        TABLE A
                                        GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
Data Requirements
                          Does EPA Have Data
                          To Satisfy This
           I/     Use  2/ Requirement?  (Yes,
Composition"    Pattern"  No or Partially)
                       Bibliographic
                         Citation
Must Additional
Data Be Submitted
Under FIPRA Section
 3(c)(2)(B)?3/
S158.150 Plant Protection

  121-1 - TARGET AREA
           PHYTOTOXICITY
    EP
  NONTARGET AREA PHYTOTOXICITY

           TIER I

  122-1 - Seed Germination/
          Seedling Emergence
   TGAI
                          No
No
                                                No 4/
       No 4/
122-1
122-2
123-1
123-1
123-2
124-1
124-2
- Vegetative vigor
- Aquatic Plant Growth
TIER II
- Seed Germination/
Seedling Emergence
- Vegetative vigor
- Aquatic Plant Growth
TIER III
- Terrestrial Field
- Aquatic Field
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
No
No
No
No
No
No
No
No 4/
No 4/
NO 4/
No 4/
No 4/
No 4/
No 4/
 17Composition:  TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
 ~   EP = End-use product.
 2/  The use patterns are coded as follows:  A = Terrestrial, Food Crop; B = Terrestrial, Non-Food  Crop;  C = Aquatic,
 ~   Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food;  G = Forestry; H = Domestic
     Outdoor I = Indoor.
 3/  Data are due  (not applicable).
 T/  These requirements are generally waived unless it is believed there is a phototoxicity  problem.
                                                              86

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                                                        TABLE A
                                        GENERIC DATA REQUIREMENTS FDR CHEMICAL DEMETON
Data Requirement
           V   Use  2/
Composition   Pattern
            Does EPA Have Data
            To Satisfy This
            Requirement?  (Yes,
            No or Partially)
                  Bibliographic
                    Citation
               Must Additional
               Data Be Submitted
               Under FIFRA Section
                3(c)(2)(B)?V
S158.155 Nontarget Insect

  NONTARGET INSECT TESTING -
  POLLINATORS:
  141-1 - Honeybee acute
           contact toxicity

  141-2 - Honeybee - toxicity
           of residues on
           foliage

  141-4 - Honeybee subacute
           feeding study

  141-5 - Field testing for
           pollinators
    TT,AI

    TEP
 A,B

 A,B
    TEP
A,B
Yes

Yes
No
00036935

00060628
No

No
                  Reserved^/


                     NoV

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                                                        TABLE A
                                   GENERIC DATA REQUIREMENTS FOR CHEMICAL DEMETON
                                                           foes EPA Have Data - Must Additional
                                                           To Satisfy This                          Data Be Submitted
                                            I/   Use  2/   Requirement?  (Yes,    Bibliographic     Under FIFRA Section
Data Requirement _ Composition   Pattern"    No or Partially) _ Citation _ 3(c)(2)(B)? V

S158.155 Nontarget Insect
         (continued)

  NONTAFGET INSECT TESTING -
          INSECTS;
  142-1 - Acute toxicity to                                                                      Reserved*/
           aquatic insects                                                                               ~

  142-2 - Aquatic insect                                                                         Reserved6/
           life-cycle study                                                                              ~

  142-3 - Simulated or actual                                                                    Reserved*/
           field testing for                                                                             ~
           aquatic insects

  143-1 - NONTARGET INSECT                                                                       Reserved*/
          TESTING - PREDATORS
  thru    AND

  143-3
  I/ Composition:  TGAT = Technical grade or the active ingredient; TEP = Typical end-use product.
  7/ The use patterns are coded as follows:  A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, Food Crop:
  "~  D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor;
     I = Indoor.
  3/ Data are due  (not applicable).
  ?/ Reserved pending development of test methodology.
  5/ Data from lower level tests do not indicate the need for a field study.
  £/ Reserved pending Agency decision as to whether the data requirement should he established.



                                                                88

-------
                                                         TABLR A
                                         GENERIC DATA REQUIREMENTS FOR DEMETCN
                                                                   noes EPA Have Data                    Must Additional
                                                                   To Satisfy This                       Data Be Submitted
                                                      Use          Requirement? (Yes,    Bibliographic   Under  FIFRA
Data Requirement	CompositionV	Pattern2/	No or Partially)	Citation	S3(c) (2) (B)?3/


   201.1  Droplet Size Spectrum       TEP               A,B,G             No                  -                 Yes
       Testing


   202.1  Drift Field                 TEP               A,B,G             No                  -                 Yes
       Evaluation
I/ Composition = TEP- TYpical end-1 use product.
7/ The use patterns are coded as follows: A=Terrestrial, Food Crop,; B=Terrestrial, Non-food Crop; OAquatic, Food Crop;
""  D=Aquatic, Non-food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor;I=Indoor
3/ Data are due February, a987.

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                                                           TABLE B
                     PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURIMS-USE PRODUCTS CONTAINING DEMETON
S158.120 - PRODUCT CHEMISTRY
Guideline Citation and
Name of Test
                                              Test    I/
                                            Substance ~
Guidelines
  Status
                                                                                     Are Data  2/
                                                                                     Required  ~
                                                                                     Yes    No
                                                                                                         Footnote
                                                                                                          Number
Product Identity;

61-1 - Product Identity and Disclosure       MP
       of ingredients

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

61-3 - Discussion of Formation of            MP
       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
                                                                          R

                                                                          R

                                                                          R




                                                                          R

                                                                          R

                                                                          R
                  jxj
                                                                 90

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                                                           TABLE R
                     PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING DEMETON
15158.120 - PRODUCT CHEMISTRY
Guideline Citation and
Name of Test
Test I/
Substance
Guidelines Are Data
Status Required 2/ Footnote
Yes No ~ Number
Physical and Chemical Characteristics
f Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-14 - Oxidizing or Reducing
Action
63-15 - Flantnability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion Characteristics
Other Requirements:
64-1 -
- Suhmittal of samples
MP
MP
MP
MP
MP
MP
MP
MP
MP
PAI
R |Xj | j
R |X| | j
CR jx| |~|
CR |X| j~j
R )Xj j~j
R (X| j j
CR |X| |~|
CR |X| j~j
R (X| |~|
CR |~| jxj

I/ Composition:  MP= Manufacturing-Use Product; PAI = Pure Active Ingredient.

2/ Data are due August, 1985.
                                                               91

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                                                        TABLE B
                PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL DEMETON
Data Requirement
Composition"
          Roes EPA Have~D~aEaT~
          To Satisfy This
I/        Requirement?  (Yes,
          No or Partially)
S158.135 Toxicology

  ACUTE TESTING

  81-1 - Acute Oral Toxicity - Rat      MP

  fil-2 - Acute nermal Toxicity          MP

  81-3 - Acute Inhalation Toxicity      MP
          - Rat

  81-4 - Primary Eye                    MP
          Irritation - Rabbit

  81-5 - Primary Dermal                 MP
          Irritation - Rabbit

  81-6 - Dermal Sensitization -         MP
          Guinea pig
                          Yes

                          Yes

                          No


                          No


                          No


                          No
Bibliographic
  Citation
Must Adaltlonal
Data Be Submitted
Under FIFRA Section
 3(c)(2)(B)?2/
                                       05002272

                                       05002272
                         No

                         No

                         Yes


                         NoV


                         NoV


                         NoV
  17Composition:MP = Manufacturing-use product, which is Systox TecTTnicaT 85% a.i.
  7/  Data are due August, 1985.
  3/  Data are not required due to the extreme acute dermal toxicity of the manufacturing-use product.
                                                               92

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                                                        TABLE C
                  PRODUCT RPRCIFIC DATA RETIREMENTS TOR END-USE PRODUCTS CONTAINING CHEMICAL DEMETON
Data Requirement
Composition"
          Does EPA Have Data
          To Satisfy This
I/        Requirement?  (Yes,
          No or Partially)
S158.135 Toxicology

  ACUTE TESTING

  81-1 - Acute Oral Toxicity- Rat       EP

  81-2 - Acute Dermal Toxicity-         F,p
         Rabbit

  81-3 - Acute Inhalation Tox-          EP
         icity- Rat
Bibliographic
  Citation
~Must Additional
 Data Be Submitted
 Under FIFRA Section
  3(c)(2)(B)?2/
                          No

                          No


                          No
                                                             YesV

                                                             YesV


                                                             Yes3/
  I/Composition:  EP = End-Use Product
  7/  Data are due August, 1985.
  3/  Registrants have the option of accepting the restricted-use classification, or submitting the data.
                                                           93

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II.  REQUIREMENT FOR SUBMISSION OF GENERIC DATA

     A.  This portion of the guidance document is a Notice
         issued under the authority of FIFRA sec. 3(c)(2)(B)
         and describes, in table format, the data required
         for maintaining the registrability of each product.
         Additionally, a bibliography (Appendix II-2) is
         included that identifies that data considered as
         part of the data base supporting this standard.
         EPA has determined that additional generic data
         described in this Notice must be submitted to EPA
         for evaluation in order to maintain in effect the
         registration(s) of your product(s) identified as
         an attachment to the cover letter accompanying this
         guidance document.  As required by FIFRA sec.
         3(c)(2)(B), you are required to take appropriate
         steps to comply with this Notice.

         EPA may suspend the registration of each of those
         products unless,  within the specified time, you have
         informed EPA how you will satisfy the requirements
         of this Notice.  Any such suspension will remain in
         effect until you have complied with the terms of
         this Notice.

     B.  What Generic Data^/ Must be Submitted.  You may
         determine which generic data you must submit by con-
         sulting Table A at the end of this chapter.  That
         table lists the generic data needed to evaluate the
         continued registrability of all products, and the
         dates by which the data must be submitted.  The
         required studies must be conducted in accordance
         with EPA approved protocols (such as those contained
         in the Pesticide Assessment Guidelines _£/ or data
         collected under the approved protocols of the
         Organization for Economic Cooperation and Development
         (OECD).  If you wish not to develop data which are
         necessary to support the reregistration of certain
   _W Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation
of the risks of all products containing that ingredient (or
all such products having a certain use pattern),  regardless
of any such product's unique composition or use.   Product-
specific data relate only to the properties or effects of a
product with a particular composition (or a group of products
with closely similar composition).

   j2/ The Pesticide Assessment Guidelines are available in
hard copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va.  22161.
                                94

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    uses appearing in your labeling, you may delete
    those uses at the time you submit your revised label-
    ing.

    Also for certain kinds of testing (generally eco-
    logical effects), EPA requires the test substance
    to be a "typical formulation, " arid in those cases
    EPA needs data of that type for each major formulation
    category (e.g., emulsifiable concentrates, wettable
    powders, granulars, etc.)  These are classified as
    generic data and when needed are specified in Table A.
    EPA may possess data on certain -"typical formu-
    lations" but not others.   Note;  The "typical formu-
    lation" data should not be confused with product-
    -specific data (Table B)  which are required on each
    formulation.  Product-specific data are further
    explained in Chapter III  of this document.

C.   Options Available for Complying With Requirements
    to Submit Data

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

    1.  (a) Notify EPA that you will submit the data, and

        (b) either submit the existing data you believe
            will satisfy the  requirement, or state that
            you will generate the data by conducting
            testing.   If the  test procedures you will
            use deviate from (or are not specified in)
            the Pesticide Assessment Guidelines or
            protocols contained in the Reports of Expert
            Groups to the Chemicals Group, Organization
            for Economic Cooperation and Development
            (OECD) Chemicals  Testing Programme, you
            must enclose the  protocols you will use.

                         OR

    2.  Notify EPA that you have entered into an agree-
        ment with one or more other registrants to
        jointly develop (or share in the cost of develop-
        ing) the data.  If you elect this option, you
        must notify EPA which registrant(s) are parties
        to the agreement.
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          3.   File with EPA a completed "Certification of
              Attempt to Enter Into an Agreement With Other
              Registrants for Development of Data"  (EPA Form
              8580-6,  Appendix II-4)V

                              OR

          4.   Request that EPA amend your registration by
              deleting the uses for which the data  are needed,
              (This option is not  available  to applicants for
              new products.)

                               OR

          5.   Request voluntary cancellation of the regis-
              tration^)  of  your products for which the data
              are needed.   (This option is not available to
              applicants  for  new products.)

      D.   Procedures  for  Requesting Changes  in Testing
          Methodology and Extensions of Time

          EPA  recognizes  that you  may disagree with our con-
          clusions  regarding  the appropriate ways to develop
          the  required data  or how quickly the data must be
          submitted.   If  the  test  procedures you plan to use
          deviate from (or are not specified in) the regis-
          tration guidelines  or  protocols contained in the
     V FIFRA sec. 3(c)(2)(B) authorizes joint development of
data by two or more registrants, arid provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement.  The statute does not compel any registrant to
agree to develop data jointly.

       In EPA's opinion, joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public interest.  Duplication of testing could
increase costs, tie up testing facilities,  and subject an unneces-
sarily large number of animals to testing.
     As noted earlier, EPA has discretion riot to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B).  EPA has concluded that
it is appropriate to exercise its discretion not to suspend in
ways which will discourage duplicative testing.  Accordingly, if
(1) a registrant has informed us of his intent to develop and
submit data required by this Notice; and (2) a second regis-
trant informs EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on
terms to be agreed upon or determined by arbitration under FIFRA
Section 3(c)(2)(B)(iii)];  and (3) the first registrant has declined
to agree to enter into a cost-sharing agreement,  EPA will not
suspend the second firm's registration.

                                 96

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          reports  of  the Expert Groups to the Chemical Groups,
          Organization  for Economic Cooperation and Development
          (OECD) Chemicals Testing Programme, you must submit
          the protocol  for Agency review prior to the initiation
          of the test.

          If you think  that you will need more time to generate
          the required  data than is allowed by EPA's schedule,
          you may  submit a request for an extension of time.
          The extension request must be submitted in writing
          to the Product Manager.  The extension request
          should state  the reasons why you conclude that an
          extension is  appropriate.  While EPA considers your
          request, you  must strive to meet the deadline for
          submitting  the required data.

III.  REQUIREMENT FOR  SUBMISSION OF PRODUCT-SPECIFIC DATA

      A necessary first step in determining which statements
      must appear on your product's label is the completion
      and submission to EPA of product-specific data* listed
      on  the form entitled "Product Specific Data Report"
      (EPA Form 8580-4, Appendix III-l) to fill "gaps" iden-
      tified by EPA concerning your product.  Under the
      authority of FIFRA sec.  3(c)(2)(B), EPA has determined
      that you must submit these data to EPA in. order to
      reregister your  product(s).  All of these data must be
      submitted not later than six months after you receive
      this guidance document.

      "Product-Specific Data Requirements for Manufacturing-
      Use Products" appearing in Table B permit you to deter-
      mine which product-specific data you must submit.
      This can be done by examining the entries in the column
      of  those tables  entitled "Must Data By Submitted Under
      §3(c)(2)(B)."
^_/ Product specific data pertain to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
                                 97

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 IV.  SUBMISSION OF REVISED LABELING  INFORMATION

     Note;  This  section  applies  to  all  products  containing
 demeton.

     FIFRA requires each  product  to  be labeled with  accurate,
 complete and  sufficient instructions and  precautions,  reflecting
 the results of data concerning the product and its ingredients.
 Labeling requirements are set out in 40  CFR  162.10 (see
 Appendix IV-1) and are summarized for products containing
 this active ingredient as part of this Guidance Document
 (See Appendix IV-2).  Applications submitted  in response to
 this notice must  include  draft labeling  for Agency review.

     If you fail  to submit revised labeling  information
 complying with this section and/or Section I, EPA may  issue
 a notice of intent to cancel the  registration under  FIFRA
 sec. 6(b)(l) .

                      A.  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" €6 Appendix IV-2.

     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
 require 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.   See Appendix IV-1.  f40 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
                              98

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 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.  See Appendix IV-1.
 [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
 See Appendix IV-1.  [40 CFR 162.10(f)j

     Item 6.   INGREDIENTS STATEMENT - An ingredients statement
 is required  on the front panel and 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.   See Appendix IV-1.   [40 CFR 162.10(g)]

     Item 6A.   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 as  Re-     "Keep  Out of  Reach
     on Front  Panel        quired Minimum  Type       of Children"
     in Square  Inches      Size All  Capitals          as Required

     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.   See Appendix IV-1.
 [40 CFR  162.10(h)(1)(ii)]

    Item 7B.   SIGNAL WORD - The signal word  (Caution, Warning,
or Danger) is required on the front panel immediately below
the child hazard warning statement.  See Appendix IV-1.
[40 CFR  162.10 (h)(l)(i)]
                                 99

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    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.  See Appendix IV-1.  [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.  See Appendix IV-1.  [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.
See Appendix IV-1.  [40 CFR 162. 10(h) (1) (iii) ]

    Item 8.  SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as 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.   See Appendix IV-1.  [40 CFR 162.10
    Item 8A.  HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard,  the
route (s) of exposure and the precautions to be taken to avoid
accident, injury or damage.   See Appendix IV-1.  [40 CFR 162.10
    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.  See Appendix IV-1.  [40 CFR
    Item 8C.  PHYSICAL OR CHEMICAL HAZARD

    1.  Flammability statement.   Precautionary statements relating
    to flammability of a product are required to appear on the
    label if it meets the criteria in Appendix IV-3 .   The require-
    ment 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.
                                100

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    2.  Criteria for declaration of non-flammability.   The
    following criteria will be used to determine if a product
    is non-flammable:

        a.  A "non-flammable gas" is a gas (or mixture of gases)
        that will not ignite when a lighted match is placed
        against the open cylinder valve.

        b.  A "non-flammable liquid" is one having a flashpoint
        greater than 350°F (177°C).

        c.  A "non-flammable aerosol" is. one which meets the
        following criteria:

            i.  The flame extension is zero inches;

            ii.  There is no flashback; and

            iii.  The flashpoint of the rion-volatile liquid
            component is greater than 350°F (177°C).

        3.  Declaration of non-flammability.  Products which
        meet the criteria for non-flammability specified
        above may bear the notation "non-flammable" or "non-
        flammable (gas, liquid, etc.)" on the label.  It may
        appear as a substatement to the ingredients statement,
        or on a back or side panel, but shall not be highlighted
        or emphasized (as with an inordinately large type
        size) in any way that may detract from precaution.

        4.  Other physical/chemical hazard statements.  When
        chemistry data demonstrate hazards of a physical or
        chemical nature other than flammability, appropriate
        statements of hazard will be prescribed.  Such statements
        may address hazards of explosivity, oxidizing or reducing
        capability,  or mixing with other substances to produce
        toxic fumes.

    Item 9.  PRODUCT CLASSIFICATION - Section 3(d) of FIFRA
requires that all pesticide formulations/uses be classified
for either general or restricted use, and that those uses
classified as restricted be limited to use by certified
applicators or persons under their direct supervision (or
subject to other restrictions that may be imposed by regulation).

    In the Registration Standard, the Agency has (1) indicated
certain formulations/uses to be restricted, based either on a
previous classification determination made through the optional
procedures of 40 CFR 162.30 or based on data already available
to the Agency, or (2) reserved any classification decision until
appropriate data are submitted.
                               101

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    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 wish to propose that your product should not be
classified for restricted use,  you must submit any information
and rationale with your application for reregistration.
During the Agency's review of your application,  your proposed
classification 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.

    A.  Classification Labeling Requirements

        1.   All Uses Restricted - Pesticide products bearing
    directions for use for formulations  or uses  classified
    restricted shall bear statements of  restricted use classi-
    fication on the front panel as described below:

            a.  The statement "RESTRICTED USE PESTICIDE,"
        must appear at the top  of the front panel of the
        label, set in type of the same  minimum sizes as
        required for human haaard signal words (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 restric-
        tion shall appear.   If  use is restricted to certified
        applicators,  the following statement is  required:
        "For retail sale to and use only by Certified Applicators
        or  persons under their  direct supervision and only
        for those uses covered  by the Certified  Applicator's
        Certification."

        2.   Some But Not all Uses Restricted - If the Regula-
    tory Position and Rationale states that some uses are
    classified for restricted use and some uses  are unclassified,
    several courses of action are available:

            a.  You may  label the product for restricted use.
        If  you do so,  you may include those 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 unres-
        tricted uses.
                               102

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

    Item 10.  MISUSE STATEMENT- The following statement is required
on your label: "It is a violation of Federal law to use this product
in a manner inconsistent with its labeling."

    Item 10A.  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
IV-4 to determine the disposal instructions appropriate for
your products.

    Item 10B.  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.  See
Appendix IV-1.  [40 CFR 162.10]


                   B.  Collateral Labeling

    Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other 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.
                          103

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V.    IKSTKUCT1GN^ FOR Sl'hMI SSICA"

    All P. i ; Z i c -1 5 or r ; •  -; -r<~'~ : •" responr   t r>  this No*:"--  ct~oul^
b-,_- addressf": ^s  follows:

    William  H. Miller-
    Product  Manager  (16)
    Registration Division  (TS-767C)
    Office- of  Pesticide Programs
    Environmental Protection Agency
    Washington,  D.C.   20460
    Phone No.  (703)  557-2400

For each product for which continued registration is desired:

A.   For Manufacturing Products (MP) containing only demeLon
    as an active ingredient.

    1.  Kith in 90 days from receipt of this document, you must
    s u bm i t:

        a. "FIFRA Section 3(c ) (2 ) (B) Summary Sheet" EPA
    Form 8580-1.   Refer to Appendix II-3 with appropriate
    attachments.

        b. Confidential  Statement of Formula, EPA form c3~0-4.

    2.  Within 6  months  from receipt of this document yc-j must
    submit:

        a.  Application for Pesticide Registration,   EPA Form
        8570-1.

        b.  Product Specific Data Report, EPA Form 8580-4
        (Appendix III-]).

        c.  Two copies  of any required product-specific data.

        d.   Two copies  of draft  labeling, including  the label and
        associated  brochures.   If current labeling conforms
        to the  requirements of  this guidance document and the
        results of  the  product-specific data, you may submit such
        labeling.  End  use product  labeling must comply specif-
        ically with the  instructions in Section II (Regulatory
        Position  and  Rationale)  of  this guidance document.
        The  labeling  should be either typewritten text on 8-1/2
        x 1]  inch paper  or a mockup of the labeling  suitable
        for  storage in  8-1/2 x 11  inch files. The draft label
        must  indicate the intended  colors of  the final label,
        clear indication  of the  front panel label, and the intended
        type  sizes  of the text.

        e.   Evidence  of  compliance  with data support requirements
        of FIFRA  sec. 3(c)(l)(D).   Refer to PR Notice 84-4
        for  latest  requirements.


                               104

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    3.   Within the times set forth in TaMeA,  all generic  data
    must 5e
    Note:  If for any reason any required test  is  delayed  or
    aBorted so that meeting the agreed  submission  time  will  be
    delayed, notify the Product Manager.

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

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

        a. "FIFRA Section 3{c)(2)(B)  Summary Sheet"  EPA
        Form 8580-1.  Refer to Appendix II-3 with  appropriate
        attachments .

        b. Confidential Statement of  Formula,  EPA  Form 8570-4

    2.  Within the times_set  f ££i!Li!l-T^~£-^ '  a11 generic
        cTata mus~C~b~e~"s~ubnn~£Tecr .

Note:  If for  any reason  any  required test  is  delayed  or
aborted so that meeting the agreed  submission  time will be
delayed, notifiy the Product  Manager.

C.  For End Use products  containing demeton  alone  or in
    combination with other  active  ingredients:

    1.  Within 90 days  from receipt of  this  document,  you must
        "sUBmlTTF

         a.  "FIFRA Section 3(c)(2)(B)  Summary Sheet" EPA
         Form 8580-1.  Refer to  Appendix II-3 with appropriate
         attachments. If you purchase a£d jj£e_as_the source of the
         active  ingredTenF"In~you£~ena-u£e^pf o3uct_onTy ^PA-reg3.sTered
         proa'ucTs~Fh'e'n~ydu are~exemjpT7From fRe__ge ne r Tc _c[a t a_req u i££l
         ments~l!or~(!eitie ton and~"need'  not _s ^mT t_ tHe _ s umma ry_ s^eeT L

         b.  Confidential Statement  of Formula,  EPA Form 8570-4.

    2.   Within 6 months from  receipt of this document you must
         submit":

         a.  Application for Pesticide Registration, EPA Form
         8570-1 .

         b.  Product  Specific  Data  Report, EPA Form 8580-4
         (Appendix  III-l ) .

         c.  Two copies  of any required product-specific data.
         (Refer to  Table C)

         d.  Two copies  of draft labeling, including the label and
         associated brochures.  If  current labeling  conforms


                                 105

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        to the requirements of this guidance document and the
        results of the short-term data, you may submit such
        labeling.   End use product labeling must comply specif-
        ically with the instructions in Section II (Regulatory
        Position and Rationale)  of this guidance document.
        The 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 inch files. The draft label
        must indicate the intended colors of the final label,
        clear indication of the front panel label, and the intended
        type sizes of the text.

        e.  Evidence of compliance with data support requirements
        of FIFRA sec. 3(c)(l)(D).  Refer to PR Notice 84-4
        for latest requirements.

3.  For those end use product registrations that are not
eligible for the formulations exemption [FIFRA sec. 3(c)(2)(D)],
submit all generic data within the time set forth in Table A.
                           106

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                                          Appendix II-l

              Guide to Use of This Bibliography


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

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

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

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

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                                   Appendix II-l (continued)

a.  Author.  Whenever the Agency could confidently identify
    one, the Agency has chosen to show a personal author.
    When no individual was identified, the Agency has
    shown an identifiable laboratory or testing facility
    as author.  As a last resort, the Agency has shown
    the first submitter as author.

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

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

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

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

    (2)  Administrative Number.  The next element, immedi-
         ately following the word "under," is the regis-
         tration 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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                                               Appendix
                OFFICE OF PESTICIDE PROGRAMS
            REGISTRATIONS STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
          Registrations under the Demeton Standard


00013531 Henderson, C.; Pickering, Q.H.; Tarzwell, C.M,
            (1959) The Toxicity of Organic Phosphorus and
            Chlorinated Hydrocarbon Insecticides to Fish:
            Report No. 4276.  (Unpublished study received
            Mar 4, 1966 under unknown admin, no.; prepared
            by U.S. Public Health Service, Robert A. Taft
            Sanitary Engineering Center, submitted by Mobay
            Chemical Corp., Agricultural Div. ,  Kansas City,
            Mo.; CDL-.130685-B)

00022923 Hill, E.F.; Heath, R,G.; Spann, J.W.;  et al.  (1975)
            Lethal Dietary Toxicities of Environmental
            Pollutants to Birds: Special Scientific Report-
            -Wildlife No. 191.  (U.S. Dept. of the Interior,
            Fish and Wildlife Service, Patuxent Wildlife
            Research Center; unpublished report)

00028625 Simmon, V.F. (1979) In vitro Microbiological
            Mutagenicity and Unscheduled DNA Synthesis
            Studies of Eighteen Pesticides: Report No. EPA-
            600/1-79-041.   (Unpublished study including
            submitter summary, received Apr 3,  1980 under
            279-2712; prepared by SRI International, submitted
            by FMC Corp., Philadelphia, Pa.; CDL: 099350-A)

00035796 Pickering, Q.H.; Henderson, C.; Lemke, A.E. (1962)
            The toxicity of organic phosphorus insecticides
            to different species of warmwater fishes.
            Transactions of the American Fisheries Society
            91(2):175-184.  (Also in unpublished submission
            received Mar 4, 1966 under unknown admin, no.;
            submitted by Mobay Chemical Corp.,  Kansas City,
            Mo.; CDL:130685-F)

00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975)
            Toxicity of Pesticides and Other Agricultural
            Chemicals to Honey Bees: Laboratory Studies.  By
            University of California, Dept. of Entomology.
            ?: UC, Cooperative Extension.   (Leaflet 2287r
            published study.)

00052735 Durham, W.F.; Gaines, T.B.; Hayes, W.J., Jr.  (1955)
            Paralytic and Related Effects of Certain Organic
            Phosphorus Compounds: Report No. 863.  (U.S.
            Public Health Service, Communicable Disease
            Center, unpublished study; CDL:107616-P)

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                OFFICE OF PESTICIDE PROGRAMS
             REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
          Registrations under the Demeton Standard


00057268 Chemagro Corporation (1962)  Stability of Di-Syston
            and Systox Residues during Frozen Storage: Report
            No. 8857.  (Unpublished study received Mar 24,
            1965 under 6F0478; submitted by Mobay Chemical
            Corp., Kansas City, Mo.;  CDL:090534-F)

00060628 Johansen, C.A.; Eves, J. (1965) Bee Poisoning
            Investigations, 1965: Report No. G-1705? Report
            No. 17338.  (Unpublished study, including letter-
            dated Jun 12, 1973 from C.A. Johansen to A.D.
            Cohick, received Mar 27,  1974 under 4F1485;
            prepared by Washington State Univ., Dept. of
            Entomology, submitted by Chemagro Corp., Kansas
            City, Mo.; CDL:092011-I)

00060630 Ludemann, D.; Neumann, H. (1971) Tests on the Acute
            Toxic Effects of the Latest Contact Insecticides
            on One-Summer Carp: Report No. 19938.  (Unpublished
            study received Mar 27, 1974 under 4F1485;
            submitted by Chemagro Corp., Kansas City, Mo.;
            CDL: 092011-K)

00071233 Anderson, C.A. (1962) Colorimetric Determination of
            Di-syston and Systox Residues in Plant Material:
            Report No. 8544.  (Unpublished study received
            Feb 4, 1962 under PP0331; submitted by Mobay
            Chemical Corp., Kansas City, Mo.;  CDL:099937-A)

00071242 Anderson, C.A. (1960) Relative cholinesterase-inhibiting
            power of several Systox derivatives:Report No. 5915.
            (Unpublished study received Jan 5, 1961 under PP0256;
            submitted by Mobay Chemical Corp;  CDL:099938-E)

00071243 Anderson, C.A. (I960) Coloriroetric Determination of
            Di-syston and Systox Residues in Plant Material:
            II. Application to Potatoes, Sugar Beets, Sugar
            Beet Tops, Cabbage, Broccoli, Pineapple, and
            Alfalfa: Report No. 5511.  Method dated Jul 25,
            1960.  (Unpublished study received Jan 5, 1961
            under PP0256; submitted by Mobay Chemical Corp.,
            Kansas City, Mo.; CDL:099938-F)

00089855 Mobay Chemical Corporation (1962) Synopsis of
            Analytical and Residue Information on Di-syston
            (Alfalfa, Broccoli, Wheat).  Includes methods
            dated Jun 2, 1961 and Jul 25, I960.  (Compilation;
            unpublished study received Apr 1,  1962 under
            PP0358; CDL:090388-A)

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                OFFICE OF PESTICIDE PROGRAMS
             REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
          Registrations under the Demeton Standard


0009318 McCann, J.A. (1970) Systox Insecticide:Rainbow Trout
            (Salmo gairdneri) Test No. 235. (U.S. Agricultural
            Research Service, Pesticides Regulation Div.
            ,  Animal Biology Laboratory, Fish Toxicity
            Laboratory; unpublished study?  CDL:130492-A)

00090378 McCann, J.A. (1970) Systox Insecticide: Bluegill
            (Leporois macrochirus): Test No. 232.  (U.S.
            Agricultural Research Service,  Pesticides
            Regulation Div., Animal Biology Laboratory, Fish
            Toxicity Laboratory; unpublished study; CDL:130477-
            A)

00095572 Chemagro Corporation (1960) Residue Report: Systox:
            Report No. 5857.  (Unpublished study received on
            unknown date under PP0244; submitted by Mobay
            Chemical Corp., Kansas City, Mo.; CDL:092521-C)

00095608 Olson, T.J. (1969) A Confirmatory Gas Chromatographic
            Procedure for  (R) Di-syston-(P) systox Residue
            Analysis: Report No. 26335.  (Unpublished study
            received Feb 2, 1970 under OF0945; submitted by
            Mobay Chemical Corp., Kansas City, Mo.; CDL:093251-
            E)

00095618 Anderson, C.A. (I960) Colorimetric Determination of
            Di-syston and  Systox Residues  in Plant Material:
            Report No. 5339.  Method dated Jun 1, 1960.
            (Unpublished study received on unknown date
            under PP0282;  submitted by Chemagro Corp., Kansas
            City, Mo.; CDL:098758-B)

00095640 Mobay Chemical Corporation (1973) Analyses for
            Residues of (R) Di-syston  in Cabbage and Broccoli.
            (Compilation;  unpublished  study, including report
            nos. 37822, 37823, 27824..., received Jun  26,
            1974 under 3125-172; CDL:102091-F)

00100829 Hensel, J.; Hewitt, A.; Sheets, U.; et al. (1952?)
            Microestimation of Demeton Residues.   (Unpublished
            study received Mar 21,  1^55 under PP0010;  prepared
            in cooperation with Pittsburgh Coke and Chemical
            Co., submitted by Mobay Chemical Corp., Kansas
            City, MO; CDL:092012-B)

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                OFFICE OF PESTICIDE PROGRAMS
             REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
          Registrations under the Demeton Standard

00100831 Kelly, M.; Hensel, J. (1954) Effect of Crop Cold
            Storage on the Cholinesterase Measurement of
            Systox Residues.  (Unpublished study received
            Mar 21, 1955 under PP0010; prepared by Pittsburgh
            Coke and Chemical Co., submitted by Mobay Chemical
            Corp., Kansas City, MO; CDL-.092012-D)

00100834 Mobay Chemical Corp. (1954) Systox: Residues on
            Pears. (Compilation; unpublished study received
            Mar 21, 1955 under PP0010; CDL:092012-H)

00100836 Mobay Chemical Corp. (1954) Systox Residue Data—
            Walnuts. (Compilation; unpublished study received
            Mar 21, 1955 under PP0010; CDL:092012-K)

00100838 Metcalf, R.;  Kukuto, T.; March, R.; et al. (1954)
            Spray Residue Tests with Systox: Oranges and
            Pears: 4452.  (Unpublished study received Mar
            21, 1955 under PP0010; prepared by Univ.  of
            California—Riverside, Dept. of Entomology,
            Citrus Experiment Station, submitted by Mobay
            Chemical Corp., Kansas City, MO; CDL:092012-M)

00100845 Muehlmann, R. (1954) Report on Tests with Radioactive
            Systox on Citrus Trees Conducted in Zebediela
            (South Africa) from Sep 29, 1953 to Jan 12,
            1954: *482.  (Translation; unpublished study
            received Mar 21, 1955 under PP0010; submitted by
            Mobay Chemical Corp., Kansas City, MO; CDL:092014-
            F)

00100863 Hensel, J.; Sheets, U. (1953) Estimation of Plant
            Residues of Systox in Potatoes by Measurement of
            Cholinesterase Inhibition.  (Unpublished study
            received Apr 6, 1955 under PP0010; prepared in
            cooperation with Pittsburgh Coke & Chemical Co.,
            submitted by Mobay Chemical Corp., Kansas City,
            MO; CDL:092295-B)

00100864 Sheets, U.; Hensel, J. (1953) Estimation of Plant
         Residues of Systox in English Walnuts by
         Measurement of Cholinesterase Inhibition.
         (Unpublished study received Apr 6, 1955 under
         PP0010; prepared by Pittsburgh Coke and Chemical
         Co., submitted by Mobay Chemical Corp., Kansas
         City, MO; CDL:092295-E)

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                OFFICE OF PESTICIDE PROGRAMS
             REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
          Registrations under the Demeton Standard


00100871 Dahm, P.; Jacobson, N. (1955?) Effects of Feeding
            Systox-treated Alfalfa Hay to Dairy Cows:
            Submitter #826.  (Unpublished study received Jan
            20, 1956 under PP0068; prepared by Iowa State
            College, submitted by Mobay Chemical Corp.,
            Kansas City,  MO; CDL:092348-B)

00100872 Fukuto, T.; Wolf, J.; Metcalf, R.; et al. (1956)
            Identification of the Sulfoxide and Sulfone
            Plant Metabolites of the Thiol Isomer of Systox:
            Submitter f1063.  (Unpublished study received
            Jan 20, 1956 under PP0068; prepared by Univ. of
            California—Riverside, Citrus Experiment Station,
            submitted by Mobay Chemical Corp., Kansas City,
            MO; CDL:092348-C)

00100877 Chemagro Corp. (1959) Microestimation of Systox
            Residues by the Cholinesterase Technique: Report
            No. 4638.  (Unpublished study received on unknown
            date under PP0230; submitted by Mobay Chemical
            Corp., Kansas City, MO; CDL:092413-B)

00100883 Mobay Chemical Corp. (1957) Systox on Hops.
            (Compilation; unpublished study received on
            unknown date under PP0121; CDL: 092402-A)

00100898 Metcalf, R.; Reynolds, H.; Fukuto, T.; et al.  (1956)
            Systox Residues in Alfalfa: Submitter #1202.
            (Unpublished study received Nov 30, 1956 under
            PP0121; prepared by Univ. of California—Riverside,
            Agricultural Experiment Station,  Dept. of
            Entomology, Citrus Experiment Station, submitted
            by Mobay Chemical Corp., Kansas City, MO;
            CDL:092402-Q)

00100902 Dahm, P.; Jacobson, N. (1956) Effects of Feeding
            Alfalfa Meal Containing Systox Residue Toxins to
            Dairy Cows: Project No. 1256; 1254.  (Unpublished
            study received Nov 30, 1956 under PP0121; prepared
            by Iowa State College, Agricultural Experiment
            Station, Depts. of Animal Husbandry and Zoology
            & Entomology; submitted by Mobay Chemical Corp.,
            Kansas City,  MO; CDL:092402-X)

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                OFFICE OF PESTICIDE PROGRAMS
             REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
          Registrations under the Demeton Standard

00100903 Ellis, L. (1956) The Physiological Effects of
            Feeding Systox Residues to Cows and Calves:
            Submitter 1378.  Master's thesis, Utah State
            Agricultural College.  (Unpublished study received
            Nov 30, 1956 under PP0121; submitted by Mobay
            Chemical Corp., Kansas City, MO;  CDL:092402-Y)

00100904 Balloun, S.; Dahm, P.; Croll, J.; et al.  (1957) A
            Summary of Poultry Feeding Studies Employing
            Rations with Alfalfa Meal Containing Systox
            Residue Toxins: Project No. 1256; #1583.
            (Unpublished study received on unknown date
            under PP0121; prepared by Iowa State College,
            Agricultural Experiment Station, Depts. of
            Poultry Husbandry and Zoology & Entomology,
            submitted by Mobay Chemical Corp., Kansas City,
            MO; CDL:092402-Z)

00100912 Williams, G. (1959) Letter sent to W. Cook dated
            Apr 30, 1959 Questions concerning Systox.
            (Unpublished study received May 4, 1959 under
            PP0205; submitted by Mobay Chemical Corp., Kansas
            City, MO; CDL:092482-F).

00100919 Mobay Chemical Corp.  (1960) Systox: Analytical and
            Residue Data: Apricots, Cottonseed, Peppers and
            Plums  (Fresh Prunes).  (Compilation; unpublished
            study  received Aug 18, 1960 under PP0264;
            CDL:092542-D)

00100921 Mobay Chemical Corp.  (1960) Systox: Analytical and
            Residue Data (Sugar Beets).   (Compilation;
            unpublished study  received Feb  2, 1961 under
            PP0293; CDL:092573-B)

00100923 Mobay Chemical Corp.  (1961) Systox: Analytical,
            Residue, and Taste Data  (Barley, Oats, and
            Wheat).  (Compilation; unpublished study received
            Mar  2, 1962 under  PP0332; CDL:092614-C)

00100926 Fukuto, T.; Metcalf,  R.; March,  R.; et al.  (1955)
            Chemical Behavior  of Systox Isomers in Biological
            Systems.   (Unpublished study  received  Feb  8,
            1955 under PP0230; prepared by  Univ. of California-
            -Riverside, Agricultural Experiment Station,
            Dept.of Entomology, Citrus  Experiment  Station,
            submitted by Chemagro Corp.,  New York, NY;
            CDL:093728-B)

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                OFFICE OF PESTICIDE PROGRAMS
             REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
          Registrations under the Demeton Standard


00100927 March, R.; Metcalf, R.;  Fukuto, T. (1955) Metabolism
            of Systox in the White Mouse and American
            Cockroach. (Unpublished study received Feb 8,
            1955 under PP0230; prepared by Univ. of California-
            -Riverside, Citrus Experiment Station, submitted
            by Chemagro Corp., New York, NY; CDL:093728-C)

00100928 Metcalf, R.; March, R. ;  Fukuto, T.; et al. (1955)
            The Nature and Significance of Systox Residues
            in Plant Materials.  (Unpublished study received
            Feb 8, 1955 under PP0230; prepared by Univ. of
            California—Riverside, Citrus Experiment Station,
            submitted by Chemagro Corp., New York, NY;
            CDL:093728-D)

00100929 Laski, R.; Sabatino, F.  (1968) Letter sent to Chief
            Chemist, Buffalo District and SC-540, Div. of
            Food Standards and Additives, Pesticides Branch
            dated Apr 29, 1968.  Calculations, chromatograms
            and method tryout on the Systox pesticide
            petition.  (U.S. Government; unpublished study;
            CDL-.098130-A)

00100930 Mobay Chemical Corp.  (1954) Systox Residue Data—
            1953. (Compilation; unpublished study received
            Jan 29, 1954 under 3125-4; CDL: 101738-A)

00100931 Mobay Chemical Corp.  (1969) Systox: Analytical and
            Residue Information on Alfalfa and Clover Grown
            for Seed.  (Compilation; unpublished study
            received Jan 12,  1970 under 3125-4; CDL:102094-
            A)

00100933 Gortner, W.  (1953) Metabolism of Radioactive Systox
            in the Pineapple  Plant: Joint Project 67.  Final
            rept.   (Unpublished study received Jan 7, 1954
            under 3125-4; submitted by Mobay Chemical Corp.,
            Kansas City, MO;  CDL:102109-B)

00100934 Cleary, T.  (1952)  Systox Residue Analyses of Refined
            Cotton Seed Oil and Meal from Field Treated
            Cotton and from Artificially Contaminated Seed
            Meats.   (Unpublished study  received Mar 6, 1952
            under 3125-4; submitted by Mobay Chemical Corp.,
            Kansas City, MO;  CDL:102110-A)

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                OFFICE OF PESTICIDE PROGRAMS
             REIGSTRATION STANDARD BIBLIOGRAPHY
Citations Considered to he Part of the Data Rase Supporting
          Registrations under the Demeton Standard
00100936 Mohay Chemical Corp. (1964) Systox: Analytical
            and Residue Data (Eggplant).  (Compilation;
            unpublished study received Sep 21, 1964 under
            .3125-4; CDL:102323-A)

00100937 Mobay Chemical Corp. (1964) Systox: Analytical and
            Residue Data (Sorghum).  (Compilation; unpublished
            study received Apr 16, 1964 under 3125-4; CDL:102324-A)

00100943 Mobay Chemical Corp. (1962) Summary Table: Di-syston
            and Systox.  (Compilation; unpublished study
            received Apr 24, 1962 under unknown admin, no.;
            CDL:120172-A)

00100956 Lamb, D.  (1971) Toxicity of Repeated Applications
            of Systox Spray  Concentrate to Juvenile Pheasants
            under Simulated  Field Conditions: Report No.
            31597.  (Unpublished  study received Dec 30,
            1971 under unknown admin, no.; submitted by Mobay
            Chemical Corp.,  Kansas  City,  MO;  CDL:12R223-A)

00100957 Lamb, D.; Nelson, D. (1971) Toxicity of  Systox 6
            Ib/gal Spray Concentrate to Bobwhite  Ouail
            under  Simulated  Apple Orchard Conditions:
            Report No. 29470.   (Unpublished  study received
            Mar 3, 1971 under unknown admin,  no.;  submitted
            by Mobay Chemical Corp., Kansas  City,  MO;  CDL:128224-A)

00100958 Lamb, D.  (1971) Toxicity of Repeated Applications
            of Systox  Spray  Concentrate  to  Bobwhite Ouail
            under  Simulated  Apple Orchard Conditions:  Report
            No. 31657.   (Unpublished  study  received Jan  18,
            1972 under 3125-221;  submitted  by Mobay Chemical
            Corp., Kansas  City,  MO;  CDL:221884-A)
 00100960  Heitmuller,  T.  (1975)
             Fiddler Crabs (uca
             (Unpublished  study
             3125-111;  prepared
             submitted by  Mobay
             MO;  CDL:221965-A)
Acute Toxicity of Systox 6 to
pugilator) Submitter 44767.
received Aug 18, 1975 under
by Bionomics—EG & G, Inc.,
Chemical Corp., Kansas City,
 00100962  Mobay Chemical Corp.  (1977)  Synopsis of Systox:
             Residue Chemistry on Forage Crops.  (Compilation;
             unpublished study received Jun 20, 1977 under
             WA 77/22;  submitted by state of Washington for
             Mobay;  CDL:236703-A)

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                OFFICE OF PESTICIDE PROGRAMS
             REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
          Registrations under the Demeton Standard


00100963 Thornton, J.; Horton,  J. (1976)  Effect of Feeding
            Systox Metabolites to Cattle: Report No. 46794.
            (Unpublished study received Jun 20, 1977 under
            WA 77/22; submitted by state of Washington for
            Mobay Chemical Corp., Kansas City, MO;
            CDL:236703-B)

00100964 Thornton, 3. (1976)  Effect of Feeding Systox
            Metabolites to Dairy Cattle: Report No. 47134.
            (Unpublished study received Jun 20, 1977 under
            WA 77/22; submitted by state of Washington for
            Mobay Chemical Corp., Kansas City, MO;
            CDL:236703-C)

00102224 Mobay Chemical Corp. (1951)  Residues of Systox in
            Fruits and Vegetables.  (Compilation; unpublished
            study received Mar 4, 1952 under 3125-4; CDL:006880-
            H)

00102232 Cleary, T.; Wagner,  W. (1950?) A Bioassay for Two
            New Insecticides.  (Unpublished study received
            Mar 4, 1952 under 3125-4;  prepared by Geary
            Chemical Corp., submitted by Mobay Chemical
            Corp., Kansas City, MO; CDL:006880-P)

00102235 Mobay Chemical Corp. (1964)  Synopsis of Analytical
            and Residue Data  of Systox: (Eggplant).
            (Unpublished study received Sep 18, 1964 under
            8F0635; CDL-.091104-A)

00102237 Mobay Chemical Corp. (1963)  Systox Residues on
            Fruits and Plants.   (Compilation; unpublished
            study received Sep 18, 1964 under 8F0635;
            CDL:091104-C)

00102239 Mobay Chemical Corp. (1967)  Synopsis of Analytical
            Information for Systox on a Variety of Crops.
            (Unpublished study received Jan 18, 1968 under
            8F0635: CDL:091106-A)
00102241 Mobay Chemical Corp. (1958)  Systox Residues in
            Cherries.  (Compilation;  unpublished study
            received Feb 12,  1958 under 3125-4; CDL-.006872-A)

00102259 Lamb, D.; Nelson, D. (1970)  Toxicity of Systox 6
            Ibs./gal.Spray Concentrate to Juvenile Pheasants
            When Applied to Alfalfa:  Report No. 28649.
            (Unpublished study received Dec 11, 1970 under
            3125-4; submitted by Mobay Chemical Corp., Kansas
            City, MO; CDL:025708-A)

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                OFFICE OF PESTICIDE PROGRAMS
             REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to he Part of the Data Rase Supporting
          Registrations under the Demeton Standard


nr)10226f) Mobay Chemical Corp. (1960) Synopsis of Analytical
            and Residue information on Systox—(Potatoes).
            (Compilation; unpublished study received Jun 3,
            I960 under 3125-4; CDL-.006864-A)

00102264 Chatters, R. (1953) Studies on the Translocation of
            Systox in Potato Plants, following  Foliage
            Applications of Phosphorus Labeled  Systox.
            (Unpublished study received May 21,  1953 under
            3125-4; prepared by Oklahoma A & M  College,
            Research Foundation,  submitted by Mohay Chemical
            Corp., Kansas City, MO; CDL: 006866-C)

00105405 Van Middelem, C.; Waites, R.  (19??) Residues of
            toxaphene, chlordane, parathion, malathion and
            demeton on several fresh vegetables.  American
            Society for Horticultural  Science:365-370 .
            (Also  In unpublished  submission received Nov  1,
            1970 under unknown admin,  no.; submitted by
            Hercules, Inc., Agricultural Chemicals, Wilmington,
            DE; CDL:005105-AC)

00112132 Pickering, 0.; Henderson,  C.; Lemke, A.  (19??) The
            toxicity of organic phosphorus  insecticides to
            different species of  warmwater  fishes.  Source
            unknown p.175-184.  (Submitter 9886;  also In
            unpublished  submission  received Jan 19, 1967
            under  unknown admin,  no.;  submitted by Mobay
            Chemical Corp.,  Kansas  City, MO; CDL:131549-C)

05002272 Gaines, T.B. (1960)  The  acute toxicity of pesticides
            to rats.  Toxicology  and  Applied pharmacology
            2:88-99 .

05000975 Tucker, R.K.; Haegele, M.A.  (1971) Comparative
            acute  oral toxicity of  pesticides  to six  species
            of birds.  Toxicology and  Applied  Pharmacology
            20(1) :57-65.

-------
                 OFFICR OF PESTICIDE PROGRAMS
              REGISTRATION STANDARD BIBLIOGRAPHY
 Citations Considered to be Part of the Data Rase Supporting
           Registrations under the Demeton Standard


 GS0143001 U.S.  Environmental Protection Agency (1980).   An
             evaluation of the effect of the demeton on sister
             chromatid exchange frequencies in cultured  Chinese
             hamster ovary cells, Final Report.  June, 1980.,
             SRI Project LSU-7558.  (Study prepared for  U.S.
             EPA by SRI International).

 GS0143002 U.S.  Environmental Protection Agency (1980).
             Micronucleus test on demeton.  Prepared February
             12, 1980; SRI Project SLU 7558-19.  (Study
             prepared for U.S. EPA by SRI International).

 GS0143003 McCann,  J.A. (1975) Systox 25% EC:  Rluegill
             sunfish (Lepomis macrochinus); Test No. 892:
             U.S. Environrne~nTaI"~P' rotecETon Agency,  Animal
             Biology Laboratory, Technical Service Div.

 GS0143004 McCann,  J.A. (1975) Systox 6: Rainbow Trout (Salrno
             gairderni): Test No. 1098; U.S. Environmental
             Protect ion Agency, Animal Biology Laboratory,
             Technical Service Div.

 GSD143005 McCann,  J.A. (1977) Systox 6: Brook Trout
             (SalvelLinus f°rvtinali_s) ; Test No. 1103; U.S.
             EnvTronmenEaT~PToTectTon Agency, Animal Biology
             Laboratory, Technical Service Div.

 GS0143006 Johnson, W.W. et al. (1980) Handbook of Acute
             Toxicity of Chemicals to fish and aquatic
             invertebrates; Resource Publication No. 137;
             U.S. Fish and Wildlife Service; Washington,
             D.C.

 GS0143007 Fukuto,  T.R., Robert L. Metacalf, Ralph R. March,
             and Marion G.  Maxon.  1955.  Chemical behavior
             of  Systox isomers in biological systems.  J.
             Econ.  Entomol.  48(4) :347-353 .  (Published study;
             no  MRID assigned).

 GS0143008 Metcalf, R.L., March, R., Fukuto, T.R., and M.G.
             Maxon.  1954.  The behavior of Systox-isomers
             in  bean and citrus plants.  Journal of Economic
             Entomology Vol. 47, No. 6, pp. 1045-1055.
             (Published study; no MRID assigned).

GS0143009 Metcalf,  R.L., Fukuto, T.R., March, R.R. and E.M.
             Stafford.  1956.  The systemic behavior of Systox
             thiol  isomer sulfoxide and methosulfate in plants.
             Journal of Economic Entomology vol. 49 No. 6,
             pp.  738-741.  (Published study; no MRID assigned)

-------
                OFFICE OF PESTICIDE PROGRAMS
             REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
          Registrations under the Demeton Standard


GS0143010 Reynolds, H.I., Fukuto, R.R., Metcalf, R.L. and
            R.B. March. 1957.  Seed treatment of field crops
            with systemic insecticides.  Journal of Economic
            Entomology, Vol. 50, No. 5 pp. 527-539.  (Submitted
            by Chemagro Corp. as report number 1783 under
            PP#0244 (113667); no MRID assigned).

GS01430.ll Thomas, W.D.E., Bennett, S.H. and C.P. Lloyd-Jones,
            1955.  The absorption, breakdown, and systemic
            behavior in plants of 32p_ia5eiied demeton-S,
            Annals of Applied Biology (London), Vol. 43, No. 4,
            pp. 569593.  (Published study; no MRID assiged) .

GS0143012 Adams, J.M.  1959.  A qualitative method for the
            determination of Systox residues in plant material.
            Chemagro Report No. 3957.  (Unpublished study
            submitted by Chemagro Co. under PP t230; no
            MRID assigned.)

GS0143013 Adams, J.M., C.A. Anderson, and D. MacDougall.
            1963.  The detection of residues of Systox and
            its toxic metabolites in the presence of other
            organophosphorus pesticides.  J. Ag. Food Chem.
            11:178-180.  (Published study; no MRID assigned.)

GS0143014 Cummings, J.G.  1962.  Method tryout for Systox on
            grain, PP#0332.  Memorandum to J.W. Cook, Chief,
            Pesticides Branch, dated May 10, 1962.  (In
            correspondence file for PP#0332; no MRID assigned).

GS0143015 Eidelman, M.  1968.  Method tryout for PP#7F0624
            (Di-syston) and PP#7F063 (Systox).  (Memorandum
            dated May 7, 1968 in the correspondence file
            for PP#7F0635; no MRID assigned.)

GS0143016 Jones, H.A.  1980.  Pesticide Petition No. 230,
            Systox, Evaluation of residue method and data.
            (Memorandum dated April 11, 1960, in the corre-
            spondence file for PP#02301 no MRID assigned.)

GS0143017 Puma, B.  1968.  Analtytical methodology for the
            determination of residues of the thiono isomer
            of  Systox.   (Memorandum dated June 25, 1968  in
            the correspondence file for PP#F0635; no MRID
            assigned.)

-------
                OFFICE OF PESTICIDE PROGRAMS
             REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to he Part of the Data Base Supporting
          Registrations under the Demeton Standard


GS0143018 Budreau, C.H. and R.P. Singh.  1973.  Teratogenicity
            and Embryotoxicity of Demeton and Fenthion in
            CF #1 Mouse Embryos.  Tox. and Applied Pharmacol.
            24:324-332.

GS0143019 Mobay Chemical Corp. (1955) Neurotoxicity of Systox
            (Unpublished study received July 25, 1955, under
            PP#10; CDL .-092015)

-------
                        Appendix  I1-3
                                                                       OMB Approval No. 2000-0468 (Expires 12-31-83)
EPAR
FIFKA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPLICANT'S NAME DATE
EGISTRATION NO.

GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FSFRA section 3(C)(2)(B) notice contained in the reference
Guidance Document, 1 am responding in the following manner:
D 1. 1 will submit data in a timely manner to satisfy the following requirements. If the test procedures 1 will
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to
Chemicals Testing Programme, 1 enclose the protocols that 1 will use:
use deviate from (or are not
the Chemicals Group, OECO
D 2. 1 have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
CD 3. 1 enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
D 4. 1 request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
d 5. 1 request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE SIGNATURE
DATE
EPA Form 8580-1 (1042)

-------
                         Appendix II-A
                                                                              OMB Approval No. 2000-0468 (Expires: 12-31-83)
(To qualify, certify /\ (. L four items)
                                         CERTIFICATION OF ATTEMPT TO ENTER
                                    INTO AN AGREEMENT WITH OTHER REGISTRANTS
                                               FOR DEVELOPMENT OF DATA
 1. I am duly authorized to represent the following firm(s) who are subject to the require-
   ments of a Notice under FIFRA Section 3(c)(2)(B) contained  in a Guidance Document
   to submit data concerning the active ingredient:
                                                                                     GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
                                     NAME OF FIRM
                                                                                              EPA COMPANY NUMBER
 (This firm or group of firms is referred to below as "my firm".)
 2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
   into an agreement with one or  more other registrants to develop jointly, or to share  in the cost of developing, the following required
   items or data:
 3.  My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to be
    bound by an arbitration decision under FIFRA Section 3(c)(2HB)(iii) if final agreement on all terms couid not be reached otherwise. This offer was made
    to the following firm(s) on the following date(s):
                                     NAME OF FIRM
                                                                                                  DATE OF OFFER
 However, none of those firm(s) accepted my offer.
 4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
   have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
   me whether my firm  must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
   does not apply to applicants for new products.)  I give EPA permission to disclose this statement upon request.
 TYPED NAME
                                                     SIGNATURE
                                                                                                        DATE
EPA Form 8580-6 (10-82)

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                                                     Appendix III-l
EPA Registration No.
 PRODUCT SPECIFIC  DATA REPORT




	Guidance Document  for




                           Date
Registration
Guideline No.
§158.20
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test

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


















I am complying with
data requirements by
Citing MRID#


















Submi t-
ting
Data
(At-
tached )


















(For EPA Use Only)
Accession Numbers
Assigned



















-------
Appendix III-l (continued)
Regi s tra tion
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
$158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage

Acute oral LD-50,
rat
Acute dermal
LD-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
( check
below)
















I am complying with
data requirements by
Citing MRID#
















Submi t-
ting
Data
(At-
tached )
















(For EPA Use Only)
Accession Numbers
Assigned

















-------
                                                       APPENDIX  IV-1
Chapter I—Environmental Protection Agency
                                                 § 162.10
  it obtained the data from anothe
     (identify); applicant copied daj/
frbm a publication; applicant obta
a copy of the data from EPA).
  (4) The applicant shall submit
his application a statement that
in iu evaluation of the properties/ effi-
cacy A and  safety  of the  formulated
end use product, may not consider any
data  Its  supporting  the appljfcation,
except the following data:
  (1) The data the applicant Aas sub-
mitted tv EPA under paragraph (b) of
this section;
  (2)  Otner  data pertainicfe  to  the
safety of the product's active ingredi-
ents, ratheV than to the
end-use prosuct; and
  (3) ExistinV tolerances,
regulations, ^exemptions,
clearances  issued unde
Pood. Drug, and Cosme
  (e) If the applicant
         Jety of the

       'ood additive
         and  other
       the Federal
      c Act.
      iows that any
Item of data he\ submnted under this
section was generatedroy (or at the ex-
pense of) anothe\peqGon who original-
ly submitted the
predecessor, USD
ary 1, 1970, to su
for  registration,
permit,  or amen
use to an exist!
reregistration  (
and the ori
reached  writ
     to EPA (or its
   on or after Janu-
  ort an application
   xperimental  use
   nt adding a new
 registration,  or for
      the applicant
dataXsubmitter have
 agreement  on  the
amount and thfe terms \pf payment of
any  compensation thatVmay be  pay-
able    under    FTFKA    section
3UXD)
and 3/CX2XD);
  (3/An identification of the ite*n(s)
of dfcta  to which the offer applies;
  («) An offer to commence negotia-
tions to ascertain the  amount and
      of compensation to be paid; and
  /(5) The applicant's name, addre
  ad telephone number.
   O If the applicant's product  coy
     any active ingredient other tt
those that are present solely because
of th\e incorporation into the pro/uct,
durink formulation, of one or/more
other Vegistered  pesticide  pibducts
purchased  from  another  p/oducer,
then the\applicant shall  als/ comply
with 5 162^-5 as to such aclflve ingre-
dient,  andVhe  application/shall  con-
tain an acknowledgment that for pur-
poses of FIF1LA section *c)(lXD) the
application reiies on (aiid any  result-
ing registratiorkshould/fee regarded as
if it were based \n the/Administrator's
                 leyfollowing data:
                   fled or specifically
                    it in support of
                      of data in  the
                            Jtted for
                           the appli-
                            stration
consideration of) i
  (1) All data subc
cited by  the appl
the registration; i
  (2) Each othes^itei
Agency's files which:
  (1) Concerns trie properties or effects
of any such active ingredient; and
  (ii) Is oneyftf  the types\f data that
EPA would/equire to be st
scientific neview by EPA
cant sou/ht the  initial
under  SIFRA  Section 3(c)
-------
§ T62.10

  (Iv)   The    product   registration
number as prescribed In paragraph (e)
of this section;
  (v)  The producing  establishment
number as prescribed In paragraph (f)
of this section:
  (vl) An Ingredient statement as pre-
scribed  In paragraph  of this sec-
tion;
  (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
  (Ix) The use  classlflcatlon(s) as pre-
scribed In paragraph (J) of this section.
  (2) Prominence and legibility.  (I) AH
words, 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
consplcuousness  (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 6-polnt or larger type:
   (B) Appear  on a clear contrasting
background;  and
   (C) Not be  obscured or crowded.
   (3) Language to be uaed. 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—(I) 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
 label can reasonably be expected  to
 remain affixed during the  foreseeable
 conditions and period of use. If the Im-
 mediate container  Is enclosed within a
  Ttt|« 40—Protection of Environment       Chopter I—Environmental Protection Agency
                                                      APFT.'JI'iX IV-l
                                                        (cont inued)

                                                                    § 167.10
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.
  (11) Tank can and other bulk con-
tainers—(At Transportation, While  a
pesticide product Is In transit,  the ap
propriate provisions of 49  CFR Parts
170-189. concerning the transportation
of ha74»rdous 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
requirements. In  addition,  when  r-iy
registered  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 the label of labeling. Including
all appropriate directions for use, shall
be securely attached to the container
In the  Immediate vicinity of the dis-
charge control  valve.
   (B) False or  misleading statements.
Pursuant to section 2(qxi>(A> of the
Act.  a  pesticide  or a device declared
subject  to  the   Act  pursuant   to
 { 162.18, to mlsbranded If Its labeling Is
 false or misleading In any particular
 Including both pestlcldal and non-pes-
 tlcldal claims. Examples of statements
 or  representations  In  the   labeling
 which constitute mlsbrmndtng Include:
   (I) A false or misleading statement
 concerning the   composition  of the
 product;
   (II) A false or  misleading statement
 concerning the  effectiveness of the
 product as a pesticide or device:
   (III) A false or misleading statement
 about  the  value of the  product for
 purposes other than as a pesticide or
 device:
   (Iv) A false or misleading comparison
 with other pesticides or devices;
   (v) Any statement directly or Indi-
 rectly  Implying  that the  pesticide or
 device  Is recommended or endorsed by
  any agency  of the  Federal  Govern-
  ment;
   (vl) The name of a pesticide  which
  contains two or more principal  active
  Ingredients If the name suggests one
  or  more  but not  all such  principal
  active  Ingredients  even  though  the
  names of  the  other  Ingredients are
  stated elsewhere In  the labeling;
   (vll) A true statement used In such a
  way as to give a false or misleading Im-
  pression to the  purchaser;
   (vlll) Isabel  disclaimers which negate
 or detract from labeling statements re-
 qulrpd under  the Act and these regula-
 tions;
   (Ix) Claims as to the safety of the
 pesticide or Its Ingredients, Including
 statements such as "safe." "nonpolson-
 ous."  "nonlnjiirlous,"  "harmless"  or
 "nontoxlc to  humans and  pets"  with
 or without such a qualifying phrase as
 "when used as directed": and
   (x) Non-numerical and/or compara-
 tive statements on  the safety of the
 product. Including but not limited to:
   (A) "Contains all natural  Ingredi-
 ents";
   (B) "Among the least  toxic chemi-
 cals known"
   (C) "Pollution approved"
   (6) Final printed labeling. (I) Except
 as provided In paragraph (a)(6HII) of
 this  section,  final  printed  labeling
 must be submitted and accepted  prior
 to registration. However,  final  printed
 labeling  need  not be submitted  until
 draft label texts have been 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.
  (2) No name,  brand, or trademark
 may appear on the label which:
  (I) Is false or misleading, or
  (II) Has not been  approved by  the
Administrator  through registration or
supplemental  registration as an addi-
tional name pursuant to S 162.6(b)(4).
   (c) Name and address of producer.
  registrant, or  person for whom  pro
  duced.  An unqualified name and  ad-
  dress given on the label shall be con-
  sidered as the name and address of  the
  producer. If the registrant's name  ap-
  pears on the label and the registrant Is
  not the producer, or If the name of  the
  person  for whom the  pesticide  was
  produced appears on the label. It must
  he qualified by appropriate  wording
  such as "Packed for •  * V "Distribut-
  ed by *  * V or "Sold by • •  •" to show
  that the name Is not  Hint of the pro-
  ducer.
   (d)  Nf.t weight  or  mrnsurr nf rnn
  tents. (1) The net weight or measure
  of content  shall be exclusive of wrap
  pers  or other materials  and shall  be
  the average content  unless explicitly
 stated as a minimum quantity.
   (2) If the pesticide  Is  a liquid,  the
 net  content  statement,  shall  be  In
 terms of liquid measure at S8" F (20"C>
 and shall be expressed In conventional
 American units of fluid ounces, pint*.
 quarts, and gallons.
   (3) If the pesticide Is solid or Rcmlso-
 lld, viscous  or pressurized, or Is a mix-
 ture  of  liquid  and solid,  the net con-
 tent  statement shall  be In terms  of
 weight   expressed  as   avoirdupois
 pounds and ounces.
   (4)  In  all  cases, net content shall  be
 stated In terms of the  largest suitable
 units. I.e., "1 pound 10 ounces" rather
 than  "23 ounces."
   (5)  In  addition io the required units
 specified, net  content may  be ex-
 pressed In metric units.
   (6)  Variation  above  minimum con
 tent or around an average Is permissi-
 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.
  (e)   Product   registration   nvmttrr.
 The registration number assigned   to
 the pesticide product  at  the time   of
 registration  shall appear on the label,
 preceded by the phrase "EPA Regis-
 tration No.," or the phrase "EPA Reg.
 No." The registration number shall  be
set In type of a size and style similar to
other print  on  that part  of the label
on which It appears and shall run par-

-------
§ 1«2.10

allel to It. The  registration number
and  the required Identifying phrase
shall not appear  In such a manner as
to suggest or Imply recommendation
or endorsement of the product by the
Agency.
  (f) Producing establishment*  regis-
tration number. The producing  estab-
lishment registration number preced-
ed by  the  phrase "EPA Est.". of the
final establishment at which the prod-
uct was produced may appear In any
suitable location on the label or  Imme-
diate container. It must appear on the
wrapper or outside container  of the
package If the EPA establishment reg-
istration  number on  the  Immediate
container  cannot be  clearly  read
through such wrapper or container.
  (g) Ingredient statement—(1) Gener-
 al 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 elemental  ar-
 senic. The active Ingredients must be
 designated by the term "active Ingredl-
 ent»" 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 size, be aligned to the same
 margin and be equally prominent. The
 statement "Inert Ingredients, none"  to
 not required for pesticides which con-
 tain  100  percent active   Ingredients.
 Unless the  Ingredient statement  Is  a
 complete  analysis of the pesticide, the
  term "analysis" shall not be used  as a
  heading for the Ingredient  statement.
   (2) Position of ingredient statement.
  (1) 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 size or  form of the
  package  makes It  Impracticable  to
  place the Ingredient  statement on the
  front panel  of  the  label, permission
  may  be  granted for  the Ingredient
  statement to appear elsewhere.
  fill, 40—Protection of Environment

  (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.
  (3)  Name*  to  be  used 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 35(0(8).
  (4) Statements of percentage*  The
percentages  of  Ingredients  shall be
stated In  terms of welght-to-welght.
The sum of percentages of the active
and the Inert Ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-28%.'  If
 the uses of  the pesticide product are
 expressed as weight of active Ingredi-
 ent per unit area, a statement of the
 weight  of active Ingredient  per unit
 volume  of the  pesticide formulation
 shall also appear  In  the Ingredient
 statement.
   (5)  Accuracy of stated percentages.
 The percentages given shall be as pre-
 cise as  possible reflecting good manu-
 facturing practice. If there may be un-
 avoidable variation between  manufac-
 turing  batches, the value stated for
 each active  Ingredient shall be the
 lowest percentage which may be pres-

   (6) Deterioration. Pesticides which
 change In chemical  composition sig-
 nificantly must meet the following la-
 beling requirements:
    t/.ip  of .t»cnal  words. Use of any
signal worrl(s) associated with R higher
           Toxlclty  Category  Is  not, permitted
           except  when the Agency determines
           that such labeling Is necessary to pre
           vent  unreasonable adverse effects on
           man  or the environment. In no  case
           shall more than  one  human hazard
           signal word appear on the front panel
           of a label.
            (II) Child hazard warning. Fvery pes
           tlclde product label  shall bear on the
           front panel the statement "keep out of
           reach  of  children."  Only  In cases
           where the likelihood of contact with
           children during distribution, 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 use on Infant,-:
           or small children, may the Administra-
           tor waive this requirement.
            (Ill)  .Statement  of practical  treat-
           ment—(A)  Toxlclty  Category  I.  A
           statement of practical treatment (first
           aid or other) shall appear on the front.
           panel of the label of nil pesticides  fall-
           Ing Into Toxlclty Category  I on  the
           basis of oral. Inhalation or dermal  tox-
           lclty.  The  Agency   may.  however.
           permit  reasonable  variations  In  the
           placement of the statement of prnctl

-------
§ 162.10

cal treatment Is some reference such
as "See  statement of  practical treat-
ment on back panel"  appears on the
front panel  near the word "Poison"
and the sKull and crossbones.
  (B) Other toxicity categories.  The
statement of practical treatment Is not
required on  the front  panel except as
described In  paragraph (h)(l)(HI)(A) of
this section. The applicant may, how-
ever. Include such a front panel state-
ment  at his  option. Statements  of
practical treatment  are.  however,  re
quired   elsewhere  on  the  label  In
accord  with paragraph (h)(2) of this
section If they do not appear on the
 front panel.
   (Iv) Placement and  prominence.  All
 the 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 size require-
 ments  for  the  front panel warning
 statements on various sizes of labels:
   ToiMy
                                          Till* 40—Protection of Environment
Siro o» «m Iron ptrwitn mum
5«ndunrJ«r_	
Abov« S 10 10.	
Abow 1010 IS	
Abov» IS 10 30
Ovor 30 	
e
8
10
1?
  (2) Other required warnings and pre-
cautionary statements. 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) Haxard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic  animals, precau-
tionary  statements are required Indi-
cating   the  particular  hazard,  the
route(s) 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

   (B) The following table depicts typi-
 cal precautionary  statement*.  These
 statement* must be  modified  o'  es
 panded to reflect specific hazards.
                  Or*. InhttaHon. or cfcrrml tontefly
           Fit* (pofnnout) I *••*>**> (Inhrtdd or «b«orb»d
             through X*). DO not be»«th« «por trjOTl w «pr»r
             mW). Do not »«t * •»«. ornkh. a on doTNng
             [Front Ptn* trtWn.nl Of pr«*c«l tr»»tm«nl r»-
             qulrwf ]
           May b* M*  II i»«»o»i««l ttnNW  o> Btotorbod
             through Th» lUn). Oo not tw»»» v«eor» I*m «
             nrn n#it). Oo not gx m •»«. on «Wn. or on
             dotNng. lApproprtiM »»< ad «t«»m«*« t*t*nt.\.
           HvnrM » nn*r**l (InMtod or •btortw) Ihrouoji m»
             •Wn) A**» bn>«thlng wwonj tdmt or «pr«Y n*t]
             Avoid OOnMCt w"tl Mn («vn or cWhJngl (Appro-
             prim Dnt tU mum** raquMd I
            tNo |»«-«iHlon«ry ll«l«m»ntt r»o*»d 1	
                                                      SMn vd •>• tooM •"«<•
      Cera**.  C.U.M •».
       MMonl  Oo  not  jl< In «r«. Or. Hdn. or on
                      O-
              Imd **) WWIon. Oo not «M In «r«.
               dW«rf *«r! •»«• Ot **> "H" pUnr, ol
    > H « n«ht)«cli HI
 imh poM tbrnK JO" F «nd out ovw WT r or K In*
 rim™* nvlfrfnlon h morn rhtin ffl In lonq nl H dHtnnc*
 of C rn r>nm (t>*» Unm^
-vtMtrrMtfy flftntmivhM Coot4*m
-------
§ 1M.10

  (/) The label clearly shows that the
product  Is Intended  for  use  only In
manufacturing processes and specifies
the type(s) of products Involved.
  (2)  Adequate Information such as
technical data sheets or bulletins. Is
available to  the trade  specifying the
type  of  product  Involved and  It*
proper use In manufacturing process-
es;
  U>  The product will not come Into
the hands of the general public except
after Incorporation Into finished prod-
ucts;  and
  «)  The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
   There  to  Information  readily
 available  to the formulators  on the
 composition, toxlclty. methods of use,
 applicable restrictions  or limitation/),
 and effectiveness  of the product for
 pesticide purposes;
   (2) The label clearly states  that the
 product Is  Intended for use only  In
 manufacturing, formulating,   mixing,
 or repacking for use as a pesticide and
 specifies the type(s) of pesticide prod-
 ucts Involved;
   (3) The product as finally mamifac-
  tured,  formulated,  mixed,  or repack-
  aged Is registered; and
    «)  The  Administrator determines
  that such directions are not necessary
  to prevent  unreasonable adverse  ef-
  fects on man or the environment.
  T1»U 40—Protection ef tnvlr»nm«n»

  (3) Contents  of Directions for V*e.
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 182.100) Immedi-
ately under  the  heading  "Directions
for Use."                       i  k
  (ID immediately below the  state-
ment of us* classification, the state-
ment "It Is a violation of Federal law
to use this product In a manner Incon-
sistent with Its labeling."
  (Ill) The sltHs) of application, as for
example the crops, animals, areas, or
objects to be treated.
  (Iv)  The target pest(s) associated
with each site.
  (v) The dosage rate associated with
each site and pest.
  (vl> The method of application. In-
cluding Instructions for dilution. If re-
quired, and  type(s) of application ap-
paratus or equipment required.
  (vll) The frequency and timing of ap-
plications necessary to obtain effective
results without  causing  unreasonable
 adverse  effects on the environment.
  (vlll) Specific limitations on reentry
 to areas where the pesticide has been
 applied,  meeting the   requirements
 concerning  reentry  provided  by 40
 CFR Part 170.
   fix) Specific  direction* concerning
 the storage  and disposal of the pesti-
 cide and Ita  container, meeting the re-
 quirements of 40 CFR Part  165. These
 Instructions  shall be   grouped  and
 appear  under the heading "Storage
 and Disposal." This heading must be
 set In type of  the same minimum slees
 as required  for the child hazard warn-
 ing (See Table In I l«.l.)
   (x) Any limitations or restrlctlo. j on
 use required to prevent unreasonable
 adverse effects, such as;
   (A) Required  Intervals between ap-
 plication and  harvest of food  or  feed
 crops.
   (B) Rotational crop restrictions.
   (C) Warnings  as required against use
 on certain  crops, animals,  objects,  or
  In or adjacent to certain areas.
   (D) (Reserved)
   (E) For restricted use pesticides, a
  statement that the pesticide  may  be
  applied under the direct supervision of
  a certified applicator who Is not phys-
  ically present at the site of application
                                                                                  Chapter I—Environmental Protection Agency
                                                                                                 Ar'M-.NDIX  IV-L
                                                                                                  (continued)
                                                                                                               § 167.11
 but  nonetheless  available  to  the
 person Applying the pesticide,  unless
 the Agency  has determined that the
 pesticide  may  only be applied  under
 the direct supervision of a certified ap-
 plicator who Is physically present.
  (P)  Other  pertinent  Information
 which  the  Administrator determines
 to  be  necessary for the protection of
 man and the environment.
  (J) Statement of Vse Classification.
 By October 22, 1918, all pesticide prod-
 ucts must bear on their labels a state-
 ment of use  classification as described
 In paragraphs (JXl) and (2) of this sec-
 tion. Any pesticide product for  which
 some uses are classified for general use
 and others  for restricted use shall be
 separately labeled according to  the la-
 beling standards set forth In this sub-
 section, and shall be marketed as sepa-
 rate products with different registra-
 tion numbers,  one bearing directions
 only for general use(s) and the other
 bearing directions for restricted use(s)
 except that.  If a product has both re-
 stricted use(s) and general use(s). both
 of these vises may appear on a product
 labeled for restricted use. Such prod-
 uct-i shall be subject to the provisions
 of 5 162.10(JK2).
  (1) General Vie Classification. Pesti-
 cide products  bearing  directions for
 wse(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 pest/clde 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)   Restricted  Use   Classification,
 Pesticide  products bearing  direction
 for use(g) classified  restricted  shall
 bear statements of restricted use clas-
 sification  on the  front panel  as de-
scribed below.
  (I) Front panel statement of restrict-
 ed use  classification. (A) At  the  top of
the front panel of the label, set In type
of the  same minimum sizes as required
 for human  hazard signal words (see
table In ) 162.10(h)(l)dv)), and appear-
ing with sufficient prominence relative
to other text and graphic material on
 the front panel to make It unlikely to
 be overlooked under customary cnndl
 tlnns of purchase  und use. the  state-
 ment. "Restricted Use Pestlrlrte" shall
 appear.
  (B) Directly below (.his statement on
 the front panel, n summary statement.
 of the terms of restriction Imposed as
 a  precondition to  registration  shall
 appear. If use Is restricted to certified
 applicators, the following statement Is
 required: "For retail sale to «nd  us*1
 only  by Certified  Applicators or nrr
 sons under their dlrrrt supervision and
 only for those uses covered by the Or
 t If led  Applicator's  rrrtlf (ration."  If.
 however, other regulatory  rrslrM.lons
 are  Imposed, the  Administrator will
 define the appropriate wording for  the
 terms of restriction by regulation.
  (k) Advertising. I Reserved!

 (40  FR  28268, July 3.  ISIS:  40 FR  .12.129.
 An*. I, 1BV5; 40 Ftt 3BS7). Au*. 21. 1975. MS
 amended at 43 FR R7BB. Frh. 9. 191*1

 (1*2.11   Criteria for rirttrmlnHtlnn* of MI,
    rmnnnahlr ailTrrw rnxift.
      Criteria for Issuance of Noticf of
 Inteat  to  Deny  Registration, Cfnc.rl
 Registration, or to Hold a  lleajnna
 (1)  Presumption. (I) A rebuttaMe pre-
 sumption shall  arise that a dotlce of
 Intent tcVleny registration pursuant to
 section  3(tX6)  of the Act./notice of
 Intent to cancel reglstratlim pursuant
 to section VbKl) of the Art.  or a
 notice of Intent  to holtf a hearing to
 determine whether  U(e  registration
 should  be cancelled or denied,  as  ap-
 propriate,  shall lie bfeued. upon  a  de-
 termination by tWeAdmlnlstrntor that
 the pesticide meetX or exceeds any of
 the criteria for rJSkVset forth In para-
 graph 
-------
     ll (X)M(SIC *N'l«MSI

        c Aur ION
    PII»SC»I On CMJMCM
   DinfClO'iS ron ust


rcm«Ai
      TORAGE AND

       DISPOSAL
\  CHOP .	
                                      PRODUCT

                                        NAME
                                 AC iivc vinn(oi(Ni

                                 urni


                                 IOIAI
                                                        too DO x
                                 i>ns rnonuci COUSINS  ins ix   rin(i«uo»(
                             » nn«l in :
                           f OH 5«n —~rrrr.

                           » n(»tS :n-~T •_:::.-:-
                               S*>r p»Hfi 'on *t)nitiOM«i rnt c*uiO'««»»t
                             M'a 1» - —-=rr. -rrr._--__:rr== /'/TN

                             iow>/ si»if —--_•—:	:—-—zmHV^y



                             rr»P|r,^in.to.,Wo	~^V
                                                                  0(1
                                KEEP OUT OF REACH OF Ct IILDRCN    ^ ©
                                      CAUTION
                                                                  te
                                                                          cnrx*
                                                                         cno*1

                                                                           COOP
                                                                           CHOP
                                                                                                          m
                                                                                                          3
                                                                                                          O,

-------
	 *qp 	
PHECAUTCNABY STATEMENTS
HAJAADS TO HUMANS
II DOMESTC ANIMAlSl
OAMOEfl


ENVfKJNMENTAl.
MA/A'nOS
PWYSCAL OO CMfMCAL
MAJATOS

         UK
  EN1WY STATEMENT
STORAGE AND

  DISPOSAL
                            RESTRICTED USE

                                PESTICIDE
                      for ret»1) illr lo tnrf uif 0"lr t>r C«rtl((t4 »ppllc«tori
                      Or f<«ri»ni under fitlr tflrttl lupirvltlon «nd only f«r
                      Ihoif «l(l C0«»r«ij bf th* Ctrliriril *pp!lc«lor« CtrtUI-
                      Cltlon, .
                            PRODUCT
                                NAME
KtRT NOflEDCWTS


TOTA1
                                             10000%
                         t»«3 PnODUCT CONTAMS  LS9 Of  PEK GALLON
                        KEEP OUT OF REACH OF CHILDREN

                      ©» DANGER -POISON
    STATEMENT Of PAAC'CAL 1REATVENT
                     r SWAUOWEO:

                     r WMALfD==

                     r ON 8KM	
                        BYf '

                         . S^ATE
                   5&ESTABU$MWENTMO
                     EPA nEt)l3TRATION MO
                               NET CONTENTS:
                     SEE SfX PANEL rOA ADOmONAt. PftfCAIITONAAY STATEMENTS
To
                                                             CHOP
                                                             CHOP
                                                             CHOP
                                    CHOP
                                    CHOP
                                                                WAMRAMTY STATEMENT
                                                                                        5
                                                                                        0-

-------
                                                                    APPENDIX IV-2
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED

ITEM
1 "
"1
3
4
-5~ ~
-M"
'6ft 	
7
TA
7B '

LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Est. No.
•SPAT Reg1. No.
TngfeHierifs
statement
Pounds/gal Ion
statement
Front panel
precautionary
statements
Keep Out of ReacK
of Children
(Child hazard
warning)
Signal word
AFPLIUWILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
ATI products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
HLAUSMEN
REOUIRED
front panel
~Norie
None
tfone
None
Front panel
Front panel"
Front panel
Front panel
Front panel
1 t>N LAbKL
| PREFERRED
j Center front
I panel
1 ~Bo€tbm~fron£
1 panel or end
1 of label text
j feottom front
I panel or end
1 of label text
j Frbnt~paneT~
1 	 .. .. .
) Front panel,
1 immediately
I before or
| following
| Reg. No.
1 Immediately
j following
I product name
| Directly BeKw
1 the main
j ingredients
1 statement
1
1
j Above signal
1 word
1
1
I Immediately
j below child
j hazard
1 warning

COMMENTS

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

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

-------
                APPENDIX  IV-2  (continued)

ITEM
7C
'/tt

"7E
• * & • - -
8A
$B

LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
Referral
statement
Side1 /back" panel
precautionary
statements
Hazards to
humans and
domestic
animals
tlnvtronmeriEal
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxic ity
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-
| REQUIRED ' j
j Front panel [
1 I
1 1
! 1
1 I
~l-~ „ '
1 Category I: j
j Front panel j
1 unless refer- j
I ra.l statement)
j is used. |
I Others : |
I Grouped with |
j side panel j
1 precautionary}
j statements, j
1 Front panel j
1 t
1 1
1
1
!
1
ftbhe j
1
1
I
1 1
j None j
I 1
1 1
1 1
I None j
1 !
ON CABEL
PREFERRED
Both in close
proximity to
signal word
Front panel
for all .

Top or side
of back panel
preceding
directions
for use
Same as above
Same as" above"
                COMMENTS
"Must~be~grouped" "und~eTr~tlTe^eadings"in""
8A, 8B,  and 8C; preferably  blocked.
"Must T5e *preced"edTy~"approprrate  s ignal"
 word.
"E"nvironmental""Razards include 5ee~
 caution where applicable.

-------
APPENDIX IV-2 (continued)

ITEM
8C
9A
9C
"10A '
IOC
lflt>

LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Re-entry
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
All
chol inesterase
inhibitors
All products
All products
PLACEMENT
REQUIRED |
None j
1
1
1
1
Top center j
of front j
panel j
1
Inmediately |
following |
statement of j
classifica- |
tion or |
ahead of |
directions j
for use |
In the j
directions j
for use j
In the j
directions j
for use |
1
1
1
1
1
None j
1
ON LA&EL
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

Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.


Must T>e set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units

-------
                                                       Appendix IV-3
Criteria
PHYSICAL-CHEMICAL HAZARDS

                   Required  Label Statement
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 1R inches
         long at a distance of
         6 inches from the
         valve opening.

      C.  ALL OTHER PRESSURIZED
         CONTAINERS
  II.  Non-Pressurized Containers

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

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

      D.  Flashpoint above
         150° F.
                   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 fron
               heat and open flame.

               Do not use or store near
               heat and open flame.

               None required.

-------
                                               Appendix lV-5

       STORAGE ftND DISPOSAL INSTRUCTIONS FOR PESTICIDES

All products are required to bear specific label instruction
about storage and disposal.  Storage and disposal instruct ic
must be grouped together in the directions for use portion o
the label under the heading STORAGE AND DISPOSAL.  Produces
intended solely for domestic use need not include the headin
"STORAGE AND DISPOSAL."  The STORAGE AND DISPOSAL heading
          r in the minimum type size listed he low-

 Size of label
 front panel  in
 square inches
 Required  type  size
 for  the heading
 STORAGE AND  DISPOSAL
(all  capitals)	
 10 and under	6 point
 Above 10 to 15	6 point
 Above 15 to 30	10 point
 Over 30	12 point
Storage and disposal  instructions must be set apart and
clearly distinguishable  from other directions for use.
Blocking storage and  disposal statements with a solid line is
suggested as a means  of  increasing their prominence.

A.  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.

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                                                 Appendix IV-5
                                                 (continued)

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.

B.   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
    appearing on the "Acutely Hazardous" Commercial Pesticide
    Products List (RCRA "E" List) at the end of this appendix
    or are assigned to Toxicity Category I on the basis of
    oral or dermal toxicity, skin or eye irritation potential,
    or Toxicity Category I or II on the basis of acute inhala-
    tion toxicity must bear the following pesticide disposal
    statement:

    "Pesticide wastes are acutely hazardous.  Improper dis-
    posal 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."

    The labels of all products, except those  intended for
    domestic use, containing active or inert  ingredients
    that appear on the "Toxic" Commercial Pesticide  Products
    List (RCRA  "F" List) at the  end of this appendix or
    presently meet any of the criteria in Subpart C, 40 CFR
    261 for a hazardous waste must bear the following pesticide
    disposal statement:

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                                                 Appendix IV-5
                                                 (centinued)

    "Pesticide wastes are toxic.  Improper disposal of excess
    pesticide, spray mixture, or rinsate is a violation cf
    Federal Law.  If these wastes cannot be disposed of b.
    use according to label instructions, contact your Stat-
    ppct-i o •>'^P ^v r-><>ironmental Control Agency, or the Haze -dous
    Waste representative at the nearest EPA Regional Offic
    for guidance."

    Labels for all other products, except those intended f;r
    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. "
                                   use only must bear the
                                   "Securely wrap original
                                   newspaper and discard in
3.  Products intended for domestic
    following disposal statement:
    container in several layers of
    trash."

C.  Container Disposal Instructions

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

    1.  All products intended for domestic use must bear one
        of the following container disposal statements:
Container
                                        Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar),
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
    2.  The labels  for all other products must bear container disposal
        instructions, based on container type, listed below:
Container Type
Metal
containers
( non-aerosol )
Plastic containers
Glass containers
Triple rinse (or
for recycling or
and dispose of in
other procedures
authorities.
Triple rinse (or
for recycling or
and dispose of in
incineration, or,
local authorities
stay out of smoke
Statement
equivalent). Then offer
reconditioning, or puncture
a sanitary landfill, or by
approved by state and local
equivalent). Then offer
reconditioning, or puncture
a sanitary landfill, or
if allowed by state and
, by burning. If burned,
•
Triple rinse (or equivalent). Then dispose
of in allsaanitary landfill or by other
approved state and local procedures.

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Container Type
                                                Appendix IV-5
                                                (continued)
                      Statement
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused-^, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording).
    ^Manufacturer
    and how fiber
may replace
drum may be
this phrase
reused.
with one indicating whether
  2. The labels for all other products must bear container
     disposal instructions, based on container type, listed
     on the first page of this Appendix.

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                                                 Appendix  IV-5
                                                 (continued)
Pesticides that are hazardous wastes under 40  CFR  261.33(e^ and  (t
when discarded.

      "Acutely Hazardous" Commercial Pesticides  (RCRA  "E"  L:  t_)_
                   Active Ingredients,  (no inerts):

Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorodithioate
      (disulfoton, Di-Syston)
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
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomy1
alpha-Naphthylthiourea  (ANTU)
Nicotine and  salts
Octamethylpyrophosphoramide  (OMPA,  schradan)
Parathion

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                                                 Appendix IV-5
                                                 (continued)
      "Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
                    Active Ingredients continued;

Phenylmercuric acetate (PMA)
Phcrate
Pot.-.ssium cyanide
Prc^argyl alcohol
So:\;um azide
Sod)urn cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate   (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
There are currently no inert ingredients for commercial pesticides
on the "Acutely Hazardous" List (RCRA "E" List).

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                                                 Appendix IV-5
                                                 (continued)

        "Toxic" Commercial Pesticide Products  (RCRA "F" List)
                         Active Ingredients;

Isobutyl alcohol
Lead acetate
Lindnne
Male.c hydrazide
Merc,ry
Methyl alcohol
Met)- 1 bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol)    (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene  (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
I,I,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane  (Freon 11 )
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid  (2,4,5-T)
Xylene

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                                               Appendix IV-5
                                               (continued)
"Toxic" Commercial Pesticide Products (RCRA
 Inert Ingredients:
           List
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene.
Chloroform
Cyclohexane
Cyclohexanone                    e
Dichlorodifluoromethane (Freon 12  )
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (mrihanol)
Methyl ethyl ketoro
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Trichloroethane
1,1,2-Trichloroethane           £
Trichlorofluoromethane (Freon 11 )
Vinyl chloride
Xylene

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                                                 Appendix  IV-5
                                                 (cont inued)

        "Toxic" Commercial Pesticide Products (RCRA "F1  List)
                         Active Ingredients:

Acetone
Aerylonitrile
Airii trole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3, 4-metheno-2H-cyclobuta [c ,d]-pent.alen-2-one
    (kepone, chlordecone)
1,2-Dibromo-3-chloropropane  (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropyIthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12  )
3, 5-Dichloro-N-( 1, l-dimethyl-2-propyny 1) benzarnide  (pronamide , Kerb)
Dichloro diphenyl  dichloroethane  (DDD)
Dichloro diphenyl  trichloroethane  (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters  and salts   (2,4-D)
1,2-Dichloropropane
1,3-Dichloropropane  (Telone)
Dimethyl phthalate
Ethyl  acetate
Ethyl  4,4'-dichlorobenzilate  (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
    *U.S. GOVERNMENT PRINTING OFFICE:

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