NTIS No. PB88-191713
                                 EPA 540/09-88-049
 PESTICIDE ASSESSMENT GUIDELINES

          SUBDIVISION 0

        RESIDUE CHEMISTRY

           Series 171-3

        Directions For Use

   ADDENDUM 6 ON DATA REPORTING
           Prepared by:

           Alfred Smith
     Residue Chemistry Branch
    Hazard Evaluation Division
         Project Manager:

    Elizabeth M.K. Leovey, PhD
    Hazard Evaluation Division
   Office of Pesticide  Programs
US Environmental Protection Agency

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              Subdivision O - Directions for Use
                Table of Contents of Addendum

                                                        Page
Introduction                                              2
Response to Public Garments                               3

Guideline
Title/Cover Page                                          4
Directions for Use                                        4
     Grope                                                4
     Formulations                                          5
     Application Directions                                5
          Field and Orchard Applications                   5
          Postharvest Applications                         6
          Animal Treatments                                7
          Aquatic Uses                                     7
          Pood-Handling Establishments                     8
          Agricultural Premises                            9
      Use Restrictions                                     9
                              -1-

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                       PESTICIDE ASSESSMENT GUIDELINES

                             RESIDUE CHEMISTRY

                             Directions For Use

                        subdivision O, Series 171-3

                               DATA REPORTING


INTRODUCTION

     A.  Purpose

         The Directions for Use are required Toy 40 CFR 162.10 to support the
         registration of any pesticide intended for use on a food or feed
         crop under the Federal Insecticide, Fungicide, and Rodenticide Act
         (FIFRA),  as amended.

         The Directions for Use form a part of the requirements for the
         registration, reregistration, or amended registration of pesticides
         intended  for use on agricultural comodities under sections 408 and
         409 of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended.
         Further regulatory support is provided in 40 CFR Parts 158.125,  162,
         and 180.

     B.  Objective

         The Directions for Use provide the user or pesticide applicator with
         the appropriate methods  for the treatment of soils, crops, water,
         establishments, livestock, and livestock areas with the pesticide.
         These uses are designed  to provide effective and efficacious means
         for treatments with pesticides.  The Directions for Use are essential
         to an adequate evaluation of  the residue data.  As a result,  such
         Directions must be clear and  reflect those uses expected to be
         effective against the target pest and  result in residues in crops.
         These data aid in the assessment of the exposure of the public to
         pesticide chemicals.  Consequently,  the uses should be supported by
         residue data Which reflect the proposed conditions of use.

         This Data Reporting Guideline (DRG)  is designed  to aid the petitioner/
         registrant in the data/information collection/organization process.
         While other DRGs provide formats  for study reports, this DRG provides
         guidance  on expressing  use directions (for the readers'  convenience,
         the guidance has been presented  in an outline format which addresses
         the items/topics to be  covered).   Data submitters are strongly
         encouraged to use this  DRG  to increase the efficiency of the registration
         and reregistration processes.  It pertains to the substance of the
         data report.  PR Notice 86-5, effective November 1, 1986 and available
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                                     -3-


          fron the Office of Pesticide Programs, pertains to physical formatting
          of reports referred to as "studies" and submittal packages.  Some of
          its requirements are mandatory.

 RESPONSE TO PUBLIC COMMENTS

     The purpose of this section is to acknowledge and address the concerns
 expressed in the letters of conment received by the Agency in response  to the
 public notice in the FEDERAL REGISTER of March 25, 1987 (52 PR 9536).   Of the
 seven responses received, two commented on the Directions for Use Data  Reporting
 Guideline.

     This addendum to the Pesticide Assessment Guidelines  [Subdivision  O]  is
 to be considered an all-enccnpassing document.  EPA recognizes there are
 sections  in the addendum which do not apply in all cases.  Therefore, registrants
 should exercise scientific judgment in deciding which portions are germane  to
 a specific  data submission.

     This DRG is not intended to introduce new data requirements or revisions
 into the  Pesticide Assessment Guidelines [Subdivision 01 nor is it intended
 for use by Agency data reviewers as a mere checklist.  It  is intended to
 clarify ambiguities in interpretation of those existing Guidelines, and to
 organize  the submission of data to facilitate the review process.

     The  Residue Chemistry Branch (RGB) has reviewed the comments submitted
 by the registrants and/or committees in regard to the DRG.  The cements
 submitted are addressed as follows (the page numbers in the comments refer
 to the page  numbers in the document available for public comment and the
corresponding section in this document*has been provided in brackets):

     Comment;

     "The expression of formulations and inerts  (page 2)  [B.]  is  incorrect.
     Formulation inerts are those inerts required to have  the  biologically
     active material function effectively in  field  use.  Adjuvants are materials
     which may be added at the time of use."

     Response;

     The  tern inert ingredient is defined under 40  CFR §162.3(t)  as "all
     ingredients which are not active ingredients . .  . ."  In order to avoid
     any confusion in the use of the tern adjuvant, the last sentence  has
     been changed to read, "The inert ingredients are all ingredients which are
     not  active ingredients  (40 CFR  162.3(t)]  and serve such functions as
     stickers or spreaders.11

     Cciuuents:

     "The paragraph at the top of page  3 1C.  1.1  and points 1 and 2 under use
     restrictions on page 6  (D. 1. and  2.1  are nearly identical,  we would
     suggest that all be included under the Use Restrictions  sections  only.
     Listing  restrictions in more than  one  place on the report may be  confusing

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     in that each list may not be complete.  The minimun interval between
     successive applications/  if relevant, could appear in the general application
     information as well."

     "On page 3, the first sentence of the last paragraph under 'Full-coverage
     sprays' [C. 1. b.] may cause sane confusion.  Vie suggest it be changed to
     '. . . should include the spray concentration or active ingredient per
     acre and the spray volume per acre.1"

     Responsei

     We agree that the paragraph at the top of page 3 [C. 1.] and points 1 and 2
     under Use Restrictions on page 6 [D. 1. and 2.] are similar.  The paragraph
     at the top of page 3 is a general statement to help explain the Application
     of Pesticides [Application Directions] introduced on page 2 [C. l.J.
     The use restrictions on page 6, points 1  and 2 
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                                -5-
    The crop groupings represent exceptions to the foregoing discussion
    (see 40 CPR 180.34).  A tolerance may be proposed for a collection
    of related crops (crop group) without Use Directions for each individual
    crop in the group.  Representative crops from the crop group may be
    provided as a minimum requirement for data purposes.  Hawever, the
    Use Directions for all crops in the group must be similar before the
    specific crop(s) is (are) registered  under FIFRA.

B.  Formulations

    The pesticide chemicals Which are to  be used are formulated as
    dusts, liquids, or granular forms. The formulation to be used must
    be expressed quantitatively in terms  of its active ingredient and
    its inert ingredients.  The inert ingredients are all ingredients
    which are not active ingredients [40  CFR 162.3(t)] and serve such
    functions as stickers or spreaders.

C.  Application Directions

    1.  Field and Orchard Applications

        The application of dusts, sprays, and granular formulations  are
        to be expressed in terms of pounds of active ingredient per  acre
        (lb ai/A).  For band or row treatments, the use should indicate
        if the pounds per acre rate refers to the area treated or to the
        entire field.

        The maximum number of applications permitted per growing season
        or per year should be provided.  Additionally, the minimum
        interval between successive applications and the minimum interval
        between the last application and  harvest should be provided.

        a.   Orchard Treatments

            The application of pesticides to orchards generally requires
            more attention than other crops due to the variations in tree
            size.  The various modes of application are discussed below.

            i.   Full-Coverage Sprays

                For full-coverage sprays  to orchards,  the dosage should
               be expressed as pounds active ingredient per 100 gallons
                spray solution to runoff.  The dosage is expressed in
                this manner because of the variation in the quantity of
               active ingredient applied per acre as a result of the
               variation in the size of the trees.

           ii.  Concentrated Sprays

                In the case of concentrated orchard sprays, the amount

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             of active ingredient applied per acre should also be
             related to tree size.  Usually this can be achieved by
             specifying the same or less active ingredient per acre
             as the amount which would be applied using a full
             coverage spray.
        iii.  Options

             In order to lessen the possibility of excess treatment,
             some options include information on the label which
             indicate that smaller trees should be treated with less
             volume of solution and thus less active ingredient per
             acre.  Alternatively, data could be provided to show
             the maximum likely residues to be expected due to
             treatment with the most concentrated spray on the
             smallest mature fruit-bearing tree in ccaroercial production.
             Additionally, methods of adjusting for tree size as
             reflected in agricultural practices should be provided.
             Some examples as recommended by the Extension Service
             will be provided in the next revision of the Residue
             Chemistry Pesticide Assessment Guidelines (Subdivision
             0:  Residue Chemistry, 40 CFR §158.125).

    b.  Special Modes

        For special modes of application (aircraft, ultra low volume
        [ULV], mist sprays), the Use Directions should include the
        spray concentration, the active ingredient per acre, and the
        spray volume per acre.  This is necessary since the volumes
        of solutions used in these cases are generally much less
        than the usual spray solutions.

2.  Postharvest Applications

    a.  Fumigation

        Fumigation generally involves the chemical treatment
        of crops which have been harvested and are being  stored or are
        already in storage.  The dosages may be expressed in  terms of
        weight of fumigant per volume of storage  space  (i.e.,  pounds
        active ingredient per 100 cubic feet), or weight  of  fumigant
        per unit weight of conmodity treated  (pounds active ingredient
        per 1000 pound grain) or weight of fumigant  per unit area
        and depth of preplant field treatment.  Other factors should
        also be considered.  The factors  include  time of  exposure,
        temperature, pressure, geometry and airtightness of containers,
        and aeration procedures which  include  tine of aeration.

    b.  Miscellaneous

        The general standards for the Directions  for Use are

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        not applicable to certain specialized processes.  For example,
        such processes include the manufacture of impregnated fruit
        wraps to control fungus diseases, or processes in Which
        pesticides are applied postharvest  to fruits, such as in a
        wax coating.  A complete description of the process, including
        quality control measures and directions for disposal of
        spent dip solutions or runoff,  should be included in the
        Proposed Use Section of a petition.

3.  Animal Treatments

    The uses on animals occur in the form of tags, backrubs, dusts,
    dips, and wetting sprays.  The concentration of the pesticide in
    the treatment solution is the primary consideration.  The Use
    Directions for dips should include instructions for recharging
    and maintaining a constant solution strength in the dip tank and
    for the disposal of spent dip solutions.  Factors Which may
    affect the deposition of residues on animals should be  included
    in the Use Directions.  Some of the factors include the frequency
    and maximum number of treatments, amount of time  that the animal
    is to be held in the dip tank, the delivery rate  of sprays, and
    the amount of solution to be applied per animal  for spot or
    other specialized treatments.

    For the application of pesticides by automatic devices, for
    example, photoelectric or actuated sprays,  or backrubbers,  the
    Use Directions should include discussions on the recharging and
    placement of devices so that the degree of exposure of the
    animals may be estimated. *

4.  Aquatic Uses

    Aquatic uses entail the application of a pesticide to flowing
    water, impounded water, irrigation ditchbanks, dry beds of water
    conveyance systems, and other aquatic sites.

    The mode of application varies and depends on the intended effect
    of the pesticide.  Herbicides for deep-growing submerged weeds
    may require deposition of slow-release granules on the bottom
    near the root zone.  For this type of  treatment, the dosage
    would be expressed in terms of pounds active ingredient per
    surface acre.  The use of a water-soluble herbicide Which acts
    by direct absorption into the target plant is dependent upon
    maintaining a certain concentration in the water, and  the dosage
    should be expressed in terms of parts per million in water.  The
    use directions should relate the dosage per surface  area to
    average pond depth.

    Specialized equipment may be required  for some aquatic herbicide
    applications.  As a result, a detailed description of  the  equipment
    and principles involved  in the treatment should  be included.   For
    example, metered pumping of invert emulsions  to  the  bottom of lakes
    through weighted hoses may be used.  A proposed  use  of time-released
    capsules will require information on how the  encapsulated  material

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    is placed and the mechanisn of the release.

    Often sane limitations on the minimum distance from a potable
    water or irrigation intake pipe are needed.  Such limitations
    are needed whenever unacceptable levels of a pesticide chemical
    occur in water at the intake pipe.

    In order to avoid losses of desirable species through oxygen
    depletion, it is sometimes necessary  to treat at intervals only
    portions of ponds with heavy weed infestations.  The label
    should state what proportions of a pond should be treated per
    application and the required interval between treatments.  If
    treatments are intended only for pond margins, as opposed to
    overall broadcast treatment, then it  should be so indicated.

    Ditchbank treatments are usually made by boon sprayers from
    trucks.  For adequate coverage there  is an unavoidable overlap
    with some direct addition to the water as well as runoff
    contamination.  The label should clearly indicate how such
    treatments are to be made with minimum contribution of herbicide
    to the water.  A prohibition may be required against  cross-ditch
    spraying.

5.  food-Handling Establishments

    The potential exists for the contamination of foods due  to
    pesticide treatment of areas where  food  is prepared or processed.
    Therefore, the applicator must have clear  Use Directions in
    order to minimize the contamination of foods.

    The Directions for Use should include:

    a.  The type of establishment that  may be  treated;

    b.  The dilution instructions for preparing the working solutions;

    c.  The spray concentration;

    d.  The type of application equipment;

    e.  The mode of application (e.g.,  directed spray to crevices,
        baseboards, space spray, etc.);

    f.  Dosage limitations including cubic and square  foot limitations;

    g.  Frequency of treatment; and

    h.  Time of treatment (e.g., after-hours in restaurants).

    Other information which should be provided, where  necessary,  are
    as follows:

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        a.  Sanitation procedures;

        b.  Removal of food;

        c.  Covering of dishes and utensils; and

        d.  Cleanup procedures before food preparation, processing, or
            serving resumes.

    6.  Agricultural Premises

        Agricultural premise  uses include distribution of granular
        insecticides to  feed  lots; fogging of dairy barns; installation of
        impregnated strips in animal barns; and applications of sugarbase
        bait sprays to walls, stanchions, and other surfaces of barns.

        The Use Directions should be sufficiently detailed to permit an
        evaluation of the potential for residues on milking equipment,
        exposure to feeds, and drinking and feed troughs, or in meat,
        milk, and eggs of livestock housed on treated premises.

        The Use Directions should state What areas are to be treated, the
        frequency of treatment,  whether animals must be removed at time of
        treatment, and any other pertinent  information.

        Dosage for fogging treatments  should be expressed in terms of nutrber
        of installations per unit volume; sprays  in terms of concentration
        of active ingredient in the solution applied;  and feed lot applications
        in terms of weight of active ingredient per unit area.

D.  Use Restrictions

    Restrictions placed on the use of the pesticide should  be clearly
    written and practical.  The following is a stannary of the use restrictions
    ccrmonly on labels,  and the information needed to adequately support
    such restrictions.

    1.  The maximum number of applications permitted during a growing
        season should be indicated.  Also, the timing of the applications
        should be noted as well as the intervals permitted between treatments.

    2.  The interval between the last application and harvest should be
        indicated.  This  interval is oomonly referred to as  the preharvest
        interval (PHI),  and expressed in days.  For animal treatments,  the
        interval between  the last treatment and slaughter  is  commonly
        referred to as the preslaughter interval (PSI) and is usually
        expressed in days.

    3.  For crops, the timing of the application may  be tied to a stage of
        crop growth.  For example, with cotton the statement "not after
        first bolls open"  is used.

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     Again,  information an the minimum interval from the treatment
     stage to harvest is needed.

 4.   Impractical or unrealistic use restrictions should be avoided.
     Restrictions on the food or feed use of plant parts are practical
     only when  (1) the item remains under the direct control of the
     grower; (2) the item is not of significant econonic importance
     as a feed  item; and, (3) the US customary practice is not to use
     the  item as a feed.  For example, a restriction on the feed use
     of soybean straw is practical because the plant refuse remains
     under the  control of the grower, the item is not of significant
     economic importance as a feed item and the percentage of US
     soybean acreage fed as forage is very low.  Also, a restriction
     in the form of a PHI would be practical for pasture grass.
     Conversely, restrictions on the feed use of corn forage or
     fodder would be impractical since these are major livestock feed
     items.  While corn forage and fodder are under the control of
     the grower, the high economic value of the feed items and the
     overwhelming practice of growers to feed these items make the
     restriction impractical.

5.   The use restrictions should be as specific as possible.  For
     example, a restriction such as "Do not use after lay-by" is
     indefinite because the "lay-by time" may vary considerably for a
    given crop.  Indefinite terms such as "Do not use on animals
    being finished for slaughter" are not acceptable.   Instead, a
     specific withdrawal period should be requested by the petitioner.

6.  Where use  in food-handling establishments is proposed,  specific
    Use Directions to minimize human exposure through residue transfer
    are needed.  Explicit warnings such as  "Cover  food  utensils" and
     "Do not apply to food contact surfaces" are most useful.  However,
    a general  statement such as "Avoid contamination of food"  is
     less useful and therefore of limited effectiveness.

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