GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS

             CONTAINING
              CAPTAFOL
      AS THE ACTIVE INGREDIENT
        EPA CASE NUMBER 116
  ENVIRONMENTAL PROTECTION AGENCY
    OFFICE OF PESTICIDE PROGRAMS
      WASHINGTON, D. C. 20460
         September 28, 1984

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                                                                                 279S1
                                    TABLE OF CONTENTS
       Introduction  	

  I.    Regulatory Position and Rationale  	        4

 II.    Requirement for Submission of Generic Data	        35a

III.    Requirement for Submission of Product-Specific data 	        59

 IV.    Submission of Revised Labeling  and Packaging Information   .  .        64

       A.  Label Contents	        64

           1.   Product Name	        64
           2.   Company Name and Address	        64
           3.   Net Contents	        64
           4.   Product Registration Number	        65
           5.   Producing Establishment
               Registration Number	        65
           6A   Ingredient Statement  	        65
           6B   Pounds Per Gallon Statement 	        65
           7.   Front Panel Precautionary  Statements  	        65
           7A   Child Hazard Warning Statements 	        66
           7B   Signal Word	        66
           7C   Skull and Crossbones and Word Poison  	        66
           7D   Statement of Practical  Treatment  	        66
           7E   Referral Statement  	        66
           8.   Side/Back Panel Precautionary Labeling  	        66
           8A   Hazard to Humans and Domestic Animals	        67
           8B   Environmental Hazard  	        67
           8C   Physical or Chemical Hazard 	        67
           9   Misuse Statement	        68
           10A Storage and Disposal Block	        68
           10B Directions for Use	        68

       B.  Collateral Information	        68

  V.    Instructions for Submission	        69

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                                  APPENDICES

                                                                      Page
II-l    Bibliography  (Including Guide for Use	70

II-2    FIFPA S3(c)(2)(B) Summary Sheet - EPA Form 8580-1	85

II-3    Certification of Attempt to Enter Into an Agreement with
        Other Registrants for Development of Data, EPA Form 8580-6 . . 86

III-l   Product Specific Data Report  	 87

IV-1    Labeling Requirements and Use Classification (40 CFR $162.10
        and 40 CFR §162.11)	88

IV-2    Table of Labeling Requirements and Sample Labels	97

17-3    Physical/Chemical Hazards Labeling Statement 	101

IV-4    Storage and Disposal Instructions	102
                                      11

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                               INTRODUCTION

     The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA
Section 3(g)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 fulfill this congressional mandate, EPA has established the
Registration 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.  The regulatory position 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 herein but is avail-
able 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 Registration Standards
program to the extent necesssary to protect the public.

     EPA has the authority under FIFRA §3(c)(2)(B) to require that
certain 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

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suppliers of the active ingredient).  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 registrant's firm, or a firm
which has ownership in common with the registrant's firm.
These end-use producers 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 followina 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 reauest the Aaency to discontinue the
registration of any of your  products subject to the reregistra-
tion 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 time-
frames outlined. EPA will issue  a notice of intent to cancel
or suspend the registration  of any currently reaistered
product if you fail to comply with the requirements set
forth in this Guidance Document.

    This Guidance Document will  be supplemented by EPA with
additional information about compliance with data support
requirements.  In Union Carbide  Agricultural Products Co., Inc
v. Ruckelshaus, EPA was recently enjoined from implementing in
any way the "mandatory data  licensing" aspects of section
3(c)(l)(D) of FIFRA.  EPA is assessing the implications of
the injunction for the reregistration process.  Because this
situation is currently unresolved, EPA has decided to proceed
with the requirements in the Guidance Document which do not
relate to compliance with the section 3(c)(l)(D) provisions
and to supplement the Document with additional guidance when
circumstances permit.  Failure to comply with the provisions
of the subsequent guidance will  also result in issuance by
EPA of a Notice of intent to cancel the affected product
registration(s).

    Registrants are reminded that S6(a)(2) of FIFRA 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 unreasonable adverse
effects.

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  PRODUCTS SUBJECT TO THE
  REGISTRATION STANDARDS PROGRAM
  ACTION(S) .REQUIRED TO
  MAINTAIN REGISTRATION
I. Products That Do Not Qualify
   For The Forraulator's Exemption

   A. Single Active Ingredient
      Products*
These products must be 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 wills.not be _.-----
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as descritfj^ in the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
II- " Products That Do Qualify For
     The Formulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to the Label Improvement
Program and special intent
to cancel notices.
* End-use products of registrants who also 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 required, 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 B above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
recuirements in I-A and B.

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                    I.  REGULATORY POSITION AND RATIONALE
A.  INTRODUCTION

    This Registration Standard describes  the regulatory position of the
Environmental Protection Agency  (EPA) on  cis-N-[1,1,2,2-tetrachloroethyl)thio] -
4-cyclohexene-l,2-dicarboximide  (captafol), based on an evaluation of the
single registered manufacturing-use product (MOP), and certain end-use
products (EOPs) containing captafol as  the sole ingredient.  Labeling requirements,!
tolerances, special local needs  registrations authorized by Section 24c of the
FIFRA, as well as registrations  under Section 3 of FIFRA were considered in
this analysis.  The Agency sets  forth the data requirements that must be
met to register or reregister products,  covered by this Standard.

    This Standard addresses registration  reouirements for current and future
MOPs and labeling requirements for EUPs.  Captafol MOPs that differ appreciably
from the one described here may  require amendments to this Standard.  Also,
use-patterns that differ from those described here may also require amendments
to this Standard.

B. DESCRIPTION OF CHEMICAL

    Captafol is the acceptable common name for cis-N-[(1,1,2,2-tetrachloro-
ethyl) thio]-4-cyclohexene-l,2-dicarboximide and is recognized by
the American National Standards  Institute.  Trade names for captafol are
Difolatan and Poleid.  Other  names include Haipen, Merpafol Ortho 5865,
Sanspor and Sulfemmide.

    There is only one (1) EPA registered  captafol MOP that may be used in
the manufacturing of end-use  pesticide  products.  The Office of Pesticide
Programs Internal Control Number (EPA Shaughnessy Number) for captafol is
081701, and its CAS Number is 2425-06-1.

    Captafol has the following identifying characteristics:

            Empirical Formula:
            Molecular Weioht:     349.1
            Structural Formula:
                                                         a®
                                                         I   i
                                                      NSC-C-H
                                                         a ci
Color:  White

Physical state:  Crystalline solid

Odor:  Slightly characeristic fumigant odor.

Melting Point:  159-161°C  (162°C, pure comDound)
                                   4

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Solubility:  Insoluble in water, very low solubility in aliphatic hydrocarbon
             solvents.  At 77°C, soluble at 2.5 g/LOO ml in isopropanol; at
             24°C, soluble at 42.8 g/100 ml in toluene.

Stability:   Stable under environmental conditions.  Decomposes slowly at
             melting point.  Very slight hydrolytic decomposition in acid or
             neutral pH at ambient temperature.  Strong sodium and potassium
             hydroxide solutions may cause spontaneous ignition of concentrate
             forms,  m neutral or weakly basic solution, captafol slowly
             decomposes, the rate depending upon pH and temperature, being
             very slow below 7.0 and rapid above 9.0.

    Captafol is a broad spectrum fungicide which is registered with the EPA
for use in the control of foliar diseases of fruits and vegetables.  It is
also registered for application to foliage of peanuts, seeds of corn, cotton,
peanuts, rice, and sorghum, to pineapple planting stock as a preplant treatment
and to wood as a preservative.  End-use products (EUPs) that have captafol
as an active ingredient may be applied as either a spray or as a dust.  As a
wood preservative it is applied as an aqueous suspension under pressure.
Captafol may be applied in combination with other fungicides and insecticides
but not with oil sprays or alkaline products such as hydra ted lime.

    Captafol fungicidal activity is resistant to ultraviolet radiation.  In
tests with selected fungi, exposure to ultraviolet radiation for 18 hours did
not significantly effect its fungicidal activity (W. D. Thomas, Phytopathology:
Vol 56: 151-152).  In field tests captafol had an average persistence on 12
plant species of 5.6 weeks (D. Neely, Phytophathology: Vol. 60: 1583-1586).

    Laboratory studies have demonstrated that captafol may move across plant
cuticle (Z. Sobel and L. V. Edgington, Phytopathology:  Vol. 63: 505-510).

    Captafol is manufactured as a 97% technical solely by Chevron Chemical
Company.  It is in 16 EPA registered products under Section 3 of FIFRA as
amended September 30, 1978, and in 19 products under 24 (c) of the Act.
These products range from 25 to 80 percent wettable powders, from 35 to 65
percent dusts, and as 27 or 39 percent flowable.  There is also an 80.0 %
water dispersible granular formulation.

C.  REGULATORY POSITION AND RATIONALE

    Based on a review and evaluation of all available data and other relevant
information on captafol, the Agency has made the following determinations:

    1.  Captafol is placed under Special Review because it has oncogenic
        potential and is very highly toxic to fish.  A Notice announcing
        the Agency's decision to initiate a Special Review will be published
        in the Federal Register.  The Agency will not consider for re-
        registration any currently registered product containing captafol
        as a sole active ingredient until the Special Review has been con-
        cluded.  However, currently registered products will remain registered
        while the Special Review is in process.

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Rationale:  Captafol has met the risk criterion for oncocrenicity
in S162.11 (a) of Title 40  (CFR).  Toxicology studies have shown
that captafol has an oncogenic potential  in rats and mice.
Dietary exposure to captafol has induced  dose-related tumors in mice
and rats.

Captafol is "very highly toxic" to fish  (96-hour LCso for rainbow
trout is 21 parts per billion (ppb)).  Reports of fish kills
involving application to cranberries identified hazards to non-
target organisms (criteria  are met or exceeded as specified in
5162.11 (3) (ii) (C) and §162.11 (3) (i)  (3)).  Under registered
use patterns, after direct  application to a 6-inch layer of water,
the use of captafol may result in a maximum calculated concentration
of more that 1/2 the acute  ££50 for aquatic organisms representative
of the organisms likely to  be exposed (as measured on test animals
specified in the Registration Guidelines).  Application rates could
result in 2,200 ppb to 9,190 ppb in 1/2 acre foot of water, thus the
criteria may be exceeded.   Hence, Special Review is necessary to
fully evaluate and determine the extent of the risk involved.

Captafol is hereby classified as a "Restricted Use" pesticide;
therefore, it is only for sale to and use by Certified Applicators
or persons under the direct supervision of a Certified Applicator.

Rationale:   Based on surrogate data, risk estimates indicate that
an unreasonable risk may exist for farm workers exposed to captafol
while mixinq and/or loading and applyina  captafol.  Dietary risk
may exist for the general population via  consumption of agricultural
commodities treated with captafol.  To reduce the risk while the
Special Review is in process, the Agency  is imposing certain interim
measures by restricting captafol use and  reouiring label amendments.

The Agency is requiring that certain data be submitted on an ex-
pedited basis.  These data  include the following:

  a.  Residue Chemistry data as specified in the data tables under
      5158.125.
  b.  Environmental Chemistry as specified in the data tables under
      5158.130.
  c.  Toxicology as specified in the data tables under S158.135.
  d.  Toxicology exposure data as specified in the data tables under
      5158.130.

Rationale:  The Agency is concerned about captafol's oncogenic
potential and needs the data mentioned above to complete the Special
Review.  In addition, in reference to residue chemistry data, a
review of these data indicate that the data are inadequate to
support registration of seed, seed-piece  and other plant propagule
uses as non-food and non-feed uses.  Data requirements to support
these uses are listed in Table A and B.

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    The available environmental fate data are insufficient to fully
    assess the potential for exposure of humans and non-target
    organisms to captafol.  When the required studies under §158.130
    are submitted, a complete environmental exposure assessment can
    be made.

4.  An interim 24-hour reentry interval has been imposed for the
    the agricultural uses of captafol until adequate data have
    been submitted as specified in Table A, Section 158.130,
    Subpart K, Re-entry.

    Rationale:  Captafol meets the criteria of 40 CFR, Section 158.140.
    Yet, there are no data to estimate reentrv exposure to workers
    entering areas treated with captafol.  Given that captafol has
    oncogenic potential, the Agency has set an interim time interval of
    24 hours to caution any worker from reenterina the treated areas
    without protective clothing.  The data gap requires the submission
    of captafol reentry data in accordance with 40 CFR Parts 158..140
    (Reentry Protection Data Requirements).  When data are submitted, the
    Agency will reevaluate this restriction.

5.  The Agency is requiring the following studies:
      a.  Environmental Chemistry data as specified in the data tables
          under $158.130.
      b.  Product Chemistry data as specified in the data tables under
          S158.120.

    Rationale:  There are inadequate data to conclude that captafol is
    not a ground water problem.  Metabolites and degradates in soil have
    not been adequately studied.  Mobility and the fate of the metabolites
    and degradates are required on an expedited basis.  The Agency
    is concerned about surface water and the possible ground water
    contamination by captafol.  In order to characterize the potential
    for captafol to enter ground water, the Agency needs the studies
    mentioned above.  For example, the available product chemistry
    data are insufficient to fullv assess the chemical at this time.
    When the required chemistry tests under S158.20 are submitted,
    a complete product chemistry evaluation can be made.
                                        %
6.  Acute toxicity studies on estuarine and marine organisms are required
    under this Standard.  Data from fish early life stage studies,
    aquatic invertebrate life cycle studies, aquatic oraanisms accumulation
    and simulated or actual field testina with aquatic organisms may be
    required for Special Review pending results from environmental
    fate studies.  Both the needed environmental fate data and the above
    mentioned data are to be submitted on a expedited basis.

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    Rationale:  The Agency is concerned about the fish toxicity and
    toxic effects to estuarine and marine organisms, because captafol
    is very highly toxic to fish.  The available environmental fate data
    are insufficient to fully assess the potential for exposure of
    humans and non-target organisms to captafol.  When the required studies
    under 40 CFR 5158.130 are submitted, a complete environmental exposure
    assessment can be made.

    There are insufficient data to characterize the acute and chronic
    toxic effects of captafol on aquatic invertebrates.  Toxicity data
    are needed for assessing the hazards to aquatic invertebrates.

7.  Product labeling must be revised to include a statement concerning
    tumors, a requirement to use protective clothing and a restricted
    use statement.  In addition, all end-use products intended for
    crop use, except seed uses and plant propaqule treatments, must
    bear labeling restrictions for crop rotation and for reentering
    treated areas.  (Refer to Section F, Required Labeling.)

    Rationale:  To reduce risk from captafol's oncogenic potential and
    its toxicity to fish, and to maintain existing registrations,
    registrants must take certain interim measures by revising product
    labeling as specified in Section F.

8.  Manufacturing-use pesticide products containing captafol as a sole
    active ingredient may be registered for sale, distribution, reform-
    ulation, and use, subject to the terms and conditions specified in
    this Standard.  Registrants must provide or agree to develop
    additional data, as specified in the tables, in order to maintain
    existing registrations or to permit new captafol reaistrations.

    Rationale:  Wider FIFRA, the Agency cannot cancel or withhold
    registration simply because data are missing or inadequate (see
    Section 3(c)(2)(b) and 3(c)(7) of  FIFRA).  Rather, issuance
    of this Standard provides a mechanism for identifying data needs
    and sets a timetable for generation of needed data.  These data
    will be reviewed and evaluated when they are received and the
    Agency will determine at that time if they will affect the
    registration of captafol products.
                              8

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D.  CRITERIA FOR REGISTRATION UNDER THIS STANDARD

    All products that contain captafol as the sole active ingredient are
subject to this standard and must bear required labeling and either comply
with the acute toxicity limits, product composition, and use patterns
requirements listed in Section E of this document, or submit data and
a justification to amend the standard to encompass such products.

E.  ACCEPTABLE RANGES AND LIMITS

    1.  Product Composition Standard

        Technical grade products must contain at least 97.0 percent captafol
        as the sole active ingredient.  Each manufacturing-use product must
        be fully described with an approoriate certification of limits.  In
        addition, the active ingredient found in the manufacturing-use captafol
        products must be substantially similar to that in the currently
        registered technical product.  Any manufacturing-use product not
        meeting these requirements will be considered a new product and will
        require an amendment to the standard.

    2.  Acute Toxicity Limits

        The Agency will consider registration of technical grade and
        manufacturing-use products containing captafol for acute toxicity
        category I, provided that the labeling of those products bear
        appropriate precautionary statements.

    3.  Use Patterns

        To be registered under this standard, manufacturing-use products
        containing captafol may be labeled for formulation only into end-use
        products for use as a funqicide for foliar applications to fruits,
        vegetables and peanuts, to seeds of corn, cotton, peanuts, rice,
        sorqhum, to pineapple planting stock as a oreplant treatment, and to
        wood as a preservative.

    4.  Labelinq of Existing Stocks
        All captafol product labeling must reflect the required labelinq
        as specified under Section F (which follows) within six months
        after the date of this Standard.

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         LABELING

All technical grade and manufacturing-use products and end-use product
(EDP's) must bear appropriate  labeling as specified below and in 40
CFR §162.10.  Other portions of  this guidance package contain specific
information regarding labeling requirements.  Required labeling must
be submitted within QQ days from the date of  receipt of  this Standard.

1.  Precautionary statements to  be used  on labeling of all end-use captafol
    products:

    a.  All end-use product labels must  reflect the following statements:
         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. "This  product  is classified as a "Restricted Use
         Pesticide because it  contains captafol which has been determined
         to cause tumors  in laboratory animals."
         Exposure to captafol  during mixing,  loading, and application may
         be hazardous to  your  health.
         This product contains captafol  which has been determined to
         cause  tumors in  laboratory animalsT

    b.  All end-use products must have the labeling claim under "Direction
        for Use":  "Wear  impervious gloves, full body clothing during handling
        and application.

    c.  All end-use products intended  for crop  use, except seed, seed
        piece,  and plant  propagule treatments must bear  the following
        use restrictions:

            i    Do not rotate  treated  crop with crops other than those
                 with registered  captafol uses.

           ii    Do not allow persons to  enter treated areas within 24 hours
                 following application  unless  protective  clothinq is worn.
                 Conspicuously  post reentry information at site of application.

           iii    Do not use captafol-treated rice seed in fields subsequently
                 to be used for agricultural crops other  than those with
                 with registerd captafol  uses.

         iiii    Water from cranberry bogs, wetland taro  fields (foliarly
                 treated with captafol) and rice fields   planted with
                 captafol-treated rice  seed must not be used for irrigation
                 of crops  other than those with  registered captafol uses.

2.  For end use products  that  bear labeling for use in greenhouses:

    a.  Only the applicator is permitted to be  in the greenhouse during appli-
        cation  of captafol to  soil. Open vents to greenhouse during
        application and at least 1 hour  after application.

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        b.  Workers plantinq in captafol treated soil in greenhouse must
            wear impervious gloves and full body clothing.

    3.  All products, manufacturing-use and end-use must bear the labeling
        precautionary statements:

        DANGER
        Causes irreversible eye damage.  Harmful if swallowed or inhaled.
        May cause allergic skin reactions.  Do not get in eyes.  Wear goggles
        or face shield when handling.  Avoid contact with skin and clothing.
        Remove and separately launder clothing before reuse.
        This product contains captafol which has been determined to cause
        tumors in laboratory animals.

    In addition, the following specific environmental hazard labeling requirements
apply to either technical, manufacturing-use and end-use product as indicated.

    a.  All technical and MUP's must bear the following precautionary
        statements:

             This pesticide is extremely toxic to fish.  DO not
             discharge into lakes, streams, ponds, or public waters
             unless in accordance with NPDES permit.  For guidance contact
             your Regional Office of the Environmental Protection Agency.
             Do not discharge effluent containing cptafol into sewage systems
             without obtaining permission from the sewage treatment authority.

     b.  All EUP's that allow foliar applications except foliar applications
         to cranberries must bear the hazard precaution:

             This pesticide is extremely toxic to fish.  Do not apply
             directly to water.  Drift and runoff from treated areas may be
             hazardous to aquatic organisms in neighboring areas.  Do not
             contaminate water by cleaning of equipment or disposal of wastes.

     c.  All EUP's that allow foliar application to cranberries must bear the
         following environmental hazard precautions:

              This pesticide is extremely toxic to fish.  Fish may
              be killed at recommendated application rates.  Drift and
              runoff from treated areas may be hazardous to aquatic
              organisms in neighboring areas.  Do not contaminate water
              by cleaning of equipment or disposal of wastes.

     d.  All EUP's that allow seed treatment must bear the following
         environmental hazard precaution:

               This pesticide is extremely toxic to fish.  Do not
               contaminate water by cleaning of equipment or disposal
               of wastes.

    4.  Both MUP's and EUP's may need special labeling to protect endangered
        species.  This will be determined after the required environmental
        chemistry data are reviewed, and in coniunction with EPA's evaluation
        of the potential risk of hazards to endangered species.

                                     11

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G.  Tolerance Reassessment

   1.  Non-Seed Applications

   The established tolerances for captafol are presently expressed as the
fungicide captafol cis-N- [Cl, 1,2,2-tetrachloroethyl) thio] -4-cyclohexene-l, 2-
dicarboximide without specifying the metabolites.  The following metabolites
have been identified in plants:

   delta4-tetrahdyrophthalimide (II), phthalimide  (III), 4,5-epoxyhexahydro-
   phthalimide (3V), 4,5-dihydroxyhexahydrophthalimide (V), 3,hydroxy-delta4
   tetrahydrophthalimide  (VI), 5-hydroxy-delta3-tetrahydrophthalimide (VII), delta4
   tetrahydrophthalamic acid  (VIII), delta4-tetrahydrophthalic acid (IX), and
   dichloroacetic acid  (XIII).

   The following table lists the present  status for tolerances in parts per
million  for residues of captafol.
Raw Agricultural Commodity
Parts Per Million in Captafol Residues

D.S.     Canada    Mexico    Codex
Apples
Apricots
Blueberries
Cherries, sour
Cherries, sweet
Citrus fruits
Corn, Fresh (sweet K+CWHR)
Cranberries
Cucumbers
Madadamia nuts
Melons
Nectarines
Peanuts, hulls
Peanuts, meats (hulls removed)
Onions
Peaches
Pineapples
Plums (fresh prunes)
Potatoes
Taro (corn)
Tomatoes
Carrots
0.25
30.0
35.0
50.0
2.0
0.5
O.l(N)
8.0
2.0
O.l(N)
5.0
2.0
2.0
0.05
O.l(N)
30.0
O.l(N)
2.0
0.5
0.02
15.0

O.l(N) —
0.5
— —
10.0
2.0 —
— —
— —
— —
2.0 —
— —
2.0 —
— —
— —
— —
O.l(N) —
15.0
— —
0.2 —
O.l(N) —
— —
5.0 —

5.0
15.0
—
10.0
2.0
—
—
8.0
2.0
O.l(N)
2.0
—
— *
0.05
0.5
15.0
10.0
10.0
0.5
—
5.0
0.5
*Codex MRL for whole peanuts is 0.5 ppm.

                                   12

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   2.  Seed Applications:

   No tolerances have been established for captafol residues in or on any
crop for which captafol is registered solely for seed treatment, because
heretofore seed treatment uses have been considered to be nonfood uses.  These
crops include: corn (field)/ cotton, peanuts, rice, sorghum (grain and forage).

   3.  Plant Metabolism:

   Available plant metabolism data are not adequate to support the established
tolerances.  Quantification and identification of captafol and its metabolites
were performed in only two studies, in each case only 7 days after last
treatment.  One of the studies was with immature tomato plants.  As indicated
in Table A, additional data must be submitted to qualify and identify residues
of captafol and its metabolites in three representative mature crops for
which use of captafol is registered.

   Future tolerances and existing tolerances must be amended to include delta^-
tetrahydrophthalimide (THPI).  Results of the required plant metabolism
studies may identify other metabolites of concern.

   4.  Animal Metabolism:

       The metabolism of captafol in ruminants is adequately understood.  The
available data on metabolism of captafol in poultry is inadequate, and therefore
residues in poultry eggs, fat, meat and meat by-products can not be assessed.
As in Table A, additional data must be submitted.

   5.  Analytical Methods for Residues:

   Adequate gas chromatography methods are available for studies on residues
of captafol in or on raw agricultural commodities or processed food or feed
commodities on which tolerances are established.  Method trials as indicated
in Table A must be conducted to evaluate methods to determine THPI, 3-OH
THPI, and 5-OH THPI in animal products, and THPI in plant commodities.

   6.  Storage Stability:

       The storage stability of captafol residues in or on animal and plant
samples is not adequately understood.  Data are needed on the stability of
captafol and its tetrahydrophthalmide metabolite in representative crops,
such as apples, cherries, citrus, potatoes, tomatoes and sweet corn, and in
or on animal products (meat, milk, eggs) stored at subfreezing temperatures
for intervals approximating the storage intervals of treated samples, in
order to determine the magnitude of the residues.

   7.  Tolerances Needed to Allow Continued Registration of Uses:

       a.  Use in Propagation of Strawberry Plants
                                   13

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     There are no available data  to support a nonfood use classification for the
use of captafol formulations on strawberries, i.e., it has not been demonstrated
that no dectectable residues will be found in or on strawberries harvested
from daughter plants which were produced  from treated mother plants.  Residues
of the captafol metabolite THPI are readily absorbed by plants (refer to
Nature of the Residue in Plants section).  The metabolism of captafol in
plants is not adequately understood.  As  a result, the captafol tolerance
expression must be reevaluated upon receipt of the required plant metabolism
data.  If residues other than intact captafol and THPI are determined to be
of concern, additional residue data for such metabolites in or on strawberries
may be required.

     The following data are required at the present time:  Residues of captafol
per se and its THPI metabolite in or on strawberries produced on daughter
plants originating from propagating plants which were treated (in the propagation
beds) at 7-day intervals beginning  May 1  with the 4 Ib/gal FIG formulation
at 3 Ib ai/A.

     Upon receipt of the above data, a decision will be made as to the appro-
priateness of the nonfood classification  of this use, and whether a tolerance is
required.  Alternatively, the registrant  may cancel this 24(c) registration.

     b.  Use on Pear Trees as a Delayed Dormant to Green Tip Stages

     An intrastate label has been issued  by the state of New York (NY Reg.
No. 038655-10453) for use of the  4  Ib/gal F1C at 5 Ib ai/LOO gal during the
delayed dormant to green tip stages.

     Data are not available for the use of captafol formulations on pear
trees nor has a tolerance been established for captafol residues in or on
pears.  A tolerance must be proposed and  the necessary data submitted, or
the intrastate label cancelled.

     If the registrant wishes to  maintain the active status of the intrastate
label, then the following data must be submitted, as well as a tolerance
proposal:

     Residue of captafol per se and THPI  in or ripe pears (or at the stage
harvested for storage) following  application of the 4 Ib/gal F1C at 5 Ib
ai/100 gal during the green tip stage.  The number of gallons applied per
acre must be specified and must be  conducted in New York.  Alternatively,
the label may be cancelled.

     c.  Use on Sugarcane Propagules.

     A Florida state [24(c)l label  for the 4 Ib/gal F1C formulation (FL760012)
is registered for seed-piece treatment at 500 ppm ai in water as a 20 minute
dip or at 12,500 ppm ai in water  as a spray.
                                   14

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     Conclusions;

     Seed treatments with captafol have been considered non-food uses.  However,
available plant metabolism data indicate that residues of captafol may be
taken up into mature plants from treated seed.  Therefore seed-piece treatments
are uses for which residue data and tolerance proposals must be submitted.
Captafol and its metabolite THPI are the residues of concern in plants;
however, the nature of the residue in plants is not adequately understood.
Should the required plant metabolism data indicate additional metabolites of
concern, then additional data and tolerance proposals for these metabolites
will be required.  The following data are required:

     Data reflecting residues of captafol and THPI in or on cane and forage
grown from seed pieces sprayed with a 12,500 ppm ai water suspension of the
4 Ib/gal F1C formulation.  Forage must be collected at intervals throughout
the growing season or until residues are no longer dectectable.  This is
necessary to determine appropriate pregrazing or prefceding intervals.  If
detectable residues occur in mature cane, then processing studies must be
completed to determine whether residues concentrate in molasses, refined
sugar and bagasse.  Tolerances must be proposed for cane and forage.  Also,
if residues concentrate in processed products, appropriate food/feed additive
tolerances must be proposed.  Tests must be conducted in sugarcane production
areas of Florida.

     Processing studies, if needed, should utilize cane bearing measurable
weathered residues.  The registrant may wish to propose label feeding and/or
grazing restrictions in lieu of submitting residue data for forage.

     d.  Use as a Seed Treatment for Cotton, Field Corn, Rice and Sorghums

     A 4 Ib/gal EC formulation is registered for seed treatments to acid
delinted cottonseed at 0.094 Ib ai/100 Ib of seed, machine delinted cottonseed
at 0.141 Ib ai/100 Ib of seed, and to rice at 0.125-0.188 Ib ai/100 Ib of
seed.  A 70% WP formulation is registered for seed treatments to field corn
at 0.47 oz ai/bushel or 0.875 Oz ai/100 Ib of seed, and to sorghum at 2.1 ozs.
ai/100 Ib of seed.

     Heretofore, seed treatments with captafol have been considered non-food
uses.  However, available plant metabolism data (refer to Nature of the
Residue in Plants section) indicate that residues of captafol may be taken up
into mature plants from treated seed.  Therefore seed treatments are uses
for which residue data and tolerance proposals must be submitted.  The nature
of the residue in plants is not adequately understood.  If the required plant
metabolism data indicate additional metabolites of concern, additional residue
data and tolerance proposals for these metabolites will be required.
                                    15

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   The following data  are required:  Data reflecting residues  of  captafol and
THPI in or on cottonseed  and  forage  grown from machine delinted  seed treated
with the 4 Ib/gal F1C  formulation at 0.141 Ib ai/100 Ib  of seed, and from
acid delinted seed  treated at 0.094  Ib ai/100 Ib of seed.

    Forage samples  must be collected at intervals throughout  the growing
season or until residues  are  no longer detectable.  This is necessary to
determine appropriate  pregrazing or  prefeeding intervals.   If detectable
residues occur in seed, then  processing studies must be  completed  to determine
whether residues concentrate  in meal, hulls,  soapstock and crude and refined
oil.  Tolerances must  be  proposed for cottonseed and forage.  Also, if residues
concentrate  in processed  products, appropriate food/feed additive  tolerances
must be proposed.   Test sites should include  California  and Texas  which produced
22% and 38%, respectively, of the U.S. cottonseed crop in 1981  (preliminary
figures; Agricultural  Statistics, 1982, p. 114).

    Data are required  reflecting residues of  captafol and THPI in  or on
field corn grain, forage, silage, and fodder  grown fron  seed  treated with
the 70% WP formulation at 0.875 oz ai/100 Ib  of seed. Forage and  silage
samples must be collected at  intervals throughout the growing season or
until residues are  no  longer  detectable.  If  detectable  residues occur in
grain, then  processing studies must  be completed to determine whether residues
concentrate  in milled  products and crude and  refined oil.   Tolerances must
be proposed  for corn grain, forage,  silage and fodder.  Also, if residues
concentrate  in processed  products, appropriate food additive  tolerances must
be proposed.  Tests should be conducted in Illinois or Iowa which  produced
13% or 17%,  respectively, of  the 1981 field corn crop (preliminary figures;
Agricultural Statistics,  1982, p. 32).

    Data are needed reflecting residues of captafol and  THPI  in  or on rice
grain and straw grown  from seed treated with  the 4 Ib/gal EC  formulation at
0.188 Ib ai/100 Ib  of  seed.  If detectable residues occur in  grain, then
processing studies  must be completed to determine whether residues concentrate
in polished  rice, hulls,  or milled products.   Tolerances must be proposed
for rice grain and  straw.  Also, if  residues  concentrate in processed products,
appropriate  food/feed  additive tolerances must be proposed.  Tests should be
conducted in Arizona and  California  which produced 37% and 23%,  respectively,
of the O.S.  rice crop  in  1981 (preliminary figures;  Agricultural Statistics,
1982, p. 21).

    Data are required  reflecting residues of  captafol and THPI in  or on
sorghum grain, forage, fodder, silage, and hay grown from seed treated with
the 70% WP formulation at 2.1 oz ai/100 Ib of seed.  Forage,  silage, and hay
samples must be taken  at  intervals throughout the growing season or until
residues are no longer detectable.  If detectable residues occur in or on
grain, then  processing studies must  be completed to determine whether residues
concentrate  in flour or milled products.  Tolerances must be  proposed for
sorghum grain, forage, fodder, silage, and hay.  Also, if residues concentrate
in processed products, appropriate food additive tolerances must be proposed.
Tests should be conducted in  Kansas  and Texas which produced  27% and 31%,
respectively, of the D.S. sorghum corp in 1981 (preliminary figures; Agricultural
Statistics,  1982, p. 52).


                                    16

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    All processing studies should utilize raw agricultural commodities
bearing measurable weathered residues.  The registrant may wish to propose
label feeding and/or grazing restrictions in lieu of submitting residue data
for forage, fodder, silage, hay or straw.

    e.  Tolerance for Residues of Captafol in Meat, Milk, Poultry or Eggs.

    The maximum expected dietary intake of residues of captafol by beef
cattle would be 7.1 ppm if the diet consisted of 20% wet citrus pulp, 5% peanut
hulls, 30% potato culls, 20% wet tomato pomace, and 25% dry tomato pomace
should the pending tolerances (PP#7F1962/FAP#7H5166) for soybean hulls (3
ppm), hay (45 ppm) and forage (15 ppm) be established, the maximum expected
intake would be 15 ppm based on a diet consisting of 5% peanut hulls, 20% wet
tomato pomace, 25% dry tomato pomace, 20% soybean hulls, 10% soybean hay and
20% soybean forage.  The maximum expected dietary intake of residues of
captafol by dairy cattle would be 5.6 ppm if the diet consisted of 25% dehydrated
citrus pulp, 10% wet citrus pulp, 30% cull potatoes, 10% wet tomato pomace,
and 25% dry tomato pomace: should the pending tolerances for soybean hav and
forage be established, the maximum intake would be 27 cpn based on a diet
consisting of 20% dry tomato pomace, 40% soybean hay, and 40% soybean forage.
The maximum expected dietary intake of residues of captafol by turkeys and
broilers would be 0.5 ppm if the diet included 5% dehydrated apple pomace,
10% peanut meal, 5% peanut soapstock, 7% potato culls, and 3% wet tomato
pomace.  Should (after Special Review has been completed) the pending
tolerance for soybeans (1 ppm) be established, the maxium expected
intake would be 1.1 ppm based on a diet which includes 20% soybean seed,
30% soybean meal and 5% soybean soapstock in addition to
the feed items listed above.  The maximum expected dietary intake of residues
of captafol by laying hens would be 0.4 ppm if the diet included 10% peanut
meal, 5% peanut soapstock, 5% pineapple bran, 20% potato culls and 2% wet
tomato pomace? should the pending tolerance for soybeans be established, the
maximum expected intake would be 1.2 ppm based on a diet consisting of 3%
pineapple bran, 20% potato culls, 2% wet tomato pomace, 50% soybean seed, 20%
soybean meal, and 5% soybean soapstock.  The maximum expected dietary intake
of residues of captafol by swine is 1.8 ppm based on a diet consisting of 1%
dyhydrated citrus pulp, 10% wet citrus pulp, 9% peanut meal, 20% pineapple
bran, 50% potato culls and 10% wet tomato pomace; should the pending tolerances
for soybeans and soybean hulls be established, the maximum expected intake
would be 2.4 ppm if the diet consisted of 35% cull potatoes, 10% wet tomato
pomace, 20% soybean seed, 20% soybean meal, 10% soybean hulls and 5% soybean
soapstock.

    The metabolism of captafol in ruminants (including milk) is adequately
understood.  The metabolism of captafol in poultry is not adequately understood
due to the inadequacy of the available metabolism study.  The established and
pending tolerances for captafol per se must be changed to reflect combined
residues of captafol and its metabolite THPI.  It is likelv that such actions
will result in increases in the magnitude of established tolerances for feed
items.  Such tolerance level increases would result in corresponding increases
in the maximum expected dietary intake of residues of concern (captafol and
THPI) by cattle, poultry and swine.
                                   17

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    The following data  requirements are based on presently established tolerances
for residues of captafol  in  feed  items:  however,  the petitioner should note
that if the feed item tolerances  are altered in the future to include residues
of the metabolite THPI, then feeding studies reflecting  the transfer of THPI
at maximum expected dietary  levels to meat,  milk, poultry and eggs will be
required.  In addition, establishment of the soybean tolerances would significantly
increase required feeding levels.  Since the metabolites of concern in poultry,
eggs, meat, and milk  have not been delineated at the present  time, data are
required reflecting residues of the parent and the metabolites THPI, PI,
3-CH THPI, and 5-OH THPI.  The following data are required:

    Cattle (> three cows/dosing level)  must  be dosed with 7,  21, and 70 ppm of
captafol in the total diet until  residues plateau in milk, or for 4 weeks if
no residues are detected  in  milk.  Milk must be sampled  twice daily.  Animals
must be slaughtered within 24 hours of  the final dose and residues (see
above) determined in  muscle, liver, kidney and fat as well as milk.

    Poultry  (>10 hens/dosing level) must be  dosed with D.5, 1.5, and 5 ppm
of captafol  in the total  diet until residues plateau in  eogs,  or for 4 weeks
if no residues are detected  in eaas. Egg samples should be taken twice
daily.  Animals must  be sacrificed within 24 hours of the final dose and
residues (see above)  determined in muscle, liver, fat, skin,  and gizzard
as well as eggs.

    As the available  metabolism studies (refer to Nature of the Residues in
Animals) have shown that  there is a reasonable expectation of residues in
meat, fat, and meat by-products of cattle, goats, hogs,  horses, and sheep, in
milk of cattle and goats,  and in  meat,  meat  by-products  and fat of poultry,
category 3 of 40 CFR  180.6(a) does not  apply.  Thus tolerances must be
proposed, based on the  above-required data,  for these animal  products.  In
addition, should the  required metabolism and/or residue  data  indicate a
reasonable expectation  of residues in eggs,  then a tolerance  proposal for
eggs will also be required.

    f.  Regulatory Concern for Residues of Captafo]3/:

    Residues of captafol  have been detected  in or on samples  of domestic
fish.  This commodity does not currently have established tolerances for
captafol residues.  It  is not known whether  the residues of captafol
in or on this commodity are  due to illegal use of captafol products
or contamination.  Additional residue monitoring is required  to determine
the cause of these illegal residues.
                                                            •»
    8.  Tolerance Reassessment Summary:

    Sufficient data are available to determine that the  currently established
tolerances for residues of captafol in  or on the following commodities are
adequate:  apricots,  blueberries, cranberries, macadamia nuts, nectarines,


a/  The Agency is concerned  about illegal residues in imported beans and
~~   imported strawberries and will consult with the PDA  on this issue.

                                   18

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peaches, peanut hulls, and taro conns (40 CFR 180.267).  However, additional
data concerning residues of metabolite THPI must be submitted for the these
commodities since the residues of concern in or on plants have recently been
modified to include THPI.  In addition to THPI data, other residue data are
required to support the tolerances for captafol in or on the following
commodities: apples, citrus fruits, corn (sweet), cucumbers, melons, onions,
peanuts, pineapples, plums (prunes), potatoes, and tomatoes.  THPI data and
tolerance changes must be submitted for sweet and sour cherries.  Residue
data and tolerance proposals must be submitted for the following commodities:
crops receiving only seed treatments (cotton, field corn, rice, and sorghum),
pears (state label use only), strawberries [propagating bed use: Section
24(c)l, sugarcane (seed piece use), and taro foliage.  Tolerances for the
following commodities are pending:  carrots, coffee beans, pecans, soybeans,
and soybean forage and hay.  Plant metabolism of captafol is not adequately
understood, therefore residues other than captafol and THPI may need to be
sought if deemed to be of concern.  The metabolites of concern in animal
products are the parent compound, THPI, 3-OH THPI, and -OH THPI.  Additional
data are required for poultry metabolism.  Also, feeding studies are required
for ruminants and poultry.  Additional storage stability data are necessary
to validate the residue data.  No crop group tolerances may be established
based on the available data.

    The TT1RC is 1.4579 mg/day based on a 1.5-kg diet.  The chancres in the
residue definition, the requested tolerance proposals and the pending tolerances
noted above will all affect a chancre in the TMPC level.  The data requirements
to support established tolerances as listed in 40 CFR 180.267 are given in
Table A.

    The Maximum Permissible Intake (MPI) for a 60 kg person is 1.68 mg/day
based on an Acceptable Daily Intake (ADI) of 0.028 mg/kg-  The present
TMRC represents 86.8% of the MPI.  The inclusion of the major metabolite
(THPI) in the tolerance expression may result in an increase in the TMRC
and a greater percentage of the MPI utilized.

    The ADI for captafol is based on a chronic toxicity study in rats.  A
NOEL was established at 56 ppm for non-oncogenic effects.  In that study
the next highest dose level caused cholangiectasis in liver, increase
in hyperplasia of tubule epithelium, megaiocytic cells and
transtional cell hyperplasia in kidney, increased erosion/ulceration
hyperkertosis/acanthosis, ground substance in glandular mucosa, and dilated
pits in stomach.  The reported dosage level was corrected from 75 ppm to
56 ppm based on the instability of captafol in the diet.  In rat 56 pan
is approximately equivalent to 2.8 mgAa«  Using a safety factor of 100
and a NOEL of 2.8 ma/kg/day, the ADI would be 0.028 mg/kcr for man.
The only registrant of technical captafol, Chevron Chemical Company, has
been requested to complete the histopathology examination of the low
and mid-dose liver and mammary aland tissues; therefore, the NOEL
may change.  The NOEL of 56 ppm is for systemic effects excluding
the issue of oncogenicity for which a risk assessment will be performed.

                                      19

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    Use Pattern Statement

    Captafol may only be used for formation into products intended for those
uses listed in F.3 above.  For more detailed use-pattern information on all
registered uses of captafol  (both single active and multiple active ingredient
products) refer to the EPA Compendium of Registered Pesticides, Volume II:
Fungicides and Nematicides, pp. C-09-95.01 to C-09-95.08 (Issue, Oct, 1974) and/or
DSE& Compilation of Registered Uses of Fungicides and Nematicides, pp. C-09-95.01
to C-09-95.11, (Issued Feb. 1, 1983), and /or EPA Index to Pesticide Chemicals
for captafol (Issued: Sept. 24, 1981).
                                    20

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H.  PRELIMINARY ANALYSIS OF CURRENT BENEFITS AND RISKS

    1.  Current Benefits Review

        a.  Introduction

The Agency has completed a preliminary review of benefits for
the major use sites for captafol.  The following information
will be expanded during the Special Review.

        b.  Use Sites

Captafol is used as a non-systemic protectant fungicide that
has a broad spectrum of activity.  It has a high level of
persistance on foliage and is apparently redistributed on
leaf surfaces by rain.  This persistence allows the growers
of certain crops to choose between applications of captafol
at minimum rates using frequent intervals or higher rates
using less frequent intervals.  It may be combined with
commonly used fungicides and insecticides, with the exception
of strongly alkaline materials and oil sprays.

Captafol is federally registered to control foliar diseases
of certain fruits and vegetables.  The major sites are
citrus, potatoes, tomatoes, sweet corn, plums, watermelon,
apples, and cherries; nearly half of the usage is for the
last two crops.  It is also federally registered for use on the
seed of corn, cotton, peanut, rice, and sorghum; peanut foliage;
cranberries; taro; pineapple planting stock; and in wood
preserving.

Approximately 4.5 to 5 million pounds are used per year.
Captafol is manufactured as a 97 percent technical by
Chevron Chemical Company.  Osmose Wood Preserving Company,
Incorporated and the University of Hawaii, Cooperative Extension
Service also hold federal registrations.  Currently, 16 products
are federally registered.  There are 19 FIFRA section 24(c)
registrations.  Formulations include 25 to 80 percent wettable
powders, 35 to 65 percent dusts, 27 or 39 percent flowable,
and 80 percent water dispensible granules.  The 39 percent
flowable is the most widely used formulation for ground and
aerial applications and is used for wood preservation and
seed treatment.

        c.  Benefits on Apples

Captafol may only be applied to apples in the mid-western and
eastern states.  It is applied by ground equipment to
control scab disease during the primary infection period.
The primary infection period is from the dormant to the
one-fourth green leaf stage of the apple tree.  It is used as
a single application spray in place of multiple applications of


                               21

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alternative fungicides.  Captafol generally is applied by an
airblast sprayer mounted on a truck or trailer.  The spray volume
will vary according to the size of the trees.  Plant protection
lasts until the blossom pink stage at the 12 pounds active
ingredient (Ib. ai.) rate dosage per acre or through blossom
petal fall of the 20 Ib. ai. per acre dosage.  Infections
during the secondary infection period must be controlled by
other fungicides because of captafol's potential phytotoxicity
to fruit and leaves.

Captafol is used primarily in Michigan, New York, and
Pennsylvania.  Use information indicate no captafol usage
in the western United States because labeling limits is use
to eastern and midwestern apples.  Several fungicides are
used more extensively on apples than captafol in the Midwest
and Northeast in terms of base acres treated and pounds
active ingredient applied.  A number of these other fungicides
are applied to control various diseases which may or may not
include apple scab.

Many registered alternatives are available. The most viable
include dichlone, captan, metiram, folpet, glyodin, thiram,
maneb, triforine, mancozeb, zineb, diammonium EBDC, and a
combination of thiophanate-methyl or benomyl with another
fungicide to which resistance has been not demonstrated.  Up to
five applications of any one of the alternatives must be
made to control the primary stage infections accomplished by
one application of captafol.  Even though captafol is much
more expensive per application than any of the other fungicides
used on apples, the difference in cost is much lower when the
number of applications required with the alternatives is
taken into account.  Since up to five applications may be
needed, it may be more expensive than using captafol.

        d.  Benefits on Cherries

Usage for cherries is limited to those which are mechanically
harvested because captafol may cause an allergic reaction in
some individual hand harvesters.  In addition, captafol may
only be applied to sour cherries, with the exception of
California and Oregon.  It is most frequently applied in the
northcentral and eastern regions of the United States and is
registered for control of Coccomyces leaf spot, brown rot
blossom blight, and fruit brown rot.  For sour cherries it
is applied using 3 to 9 Ib. ai. per acre, depending on disease
severity.  For cherries in California and Oregon a rate of
2.4 to 4.8 Ib. ai. per acre is used.  Application is generally
made using airblast sprayers.
                            22

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For control of Coccomyces leaf spot disease, growers may choose
a "seasonal program" or a "reduced application program." For
the seasonal program, captafol may be applied at 0.5 to 1.0 Ib.
ai. in 100 gallons of water at 10 day intervals for three to
four treatments beginning at petal fall.  The application
may be the same as those used for fruit brown rot.  For the
reduced application program captafol is applied once at
petal fall using 3.0 Ib. ai. in 100 gallons of water.  This
treatment may overlap one or more brown fruit rot treatments.

For brown rot blossom blight, captafol is applied using
three to six applications at two to four day intervals starting
at blossom development and continuing through petal fall.
It may be applied at 1.0 Ib. ai. in 100 gallons of water.  In
major sour cherry producing states such as Michigan and Oregon,
generally 300 gallons and 400 gallons per acre, respectively,
are used.

For fruit brown rot, captafol is applied at 0.5 to 1.0 Ib. ai.
in 100 gallons of water and is applied when conditions are
favorable for disease development, such as extended periods
of rain.  The history of disease in an orchard is also considered
Four applications may be made at ten day intervals from
petal fall and one application may be made after harvest.

With the exception of benomyl, captafol is the most expensive
fungicide per acre of application.  Despite its cost, it is
still one of the most extensively used fungicides on cherries
in the northcentral and eastern parts of the U.S.  The
most viable alternatives for these three diseases are dichlone,
dodine, ziram, and benomyl used in combination with a fungicide
against which resistance has not been demonstrated.  Other
viable alternatives are also available, depending on the
disease.  For brown rot blossom blight and fruit brown rot
additional alternatives include captan, sulfur, and triforine.
For leaf spot control glyodine, folpet, and zineb are available.

        e.  Benefits on Tomatoes

Captafol is limited for use on tomatoes which are
mechanically harvested.  Generally these tomatoes are destined
for processing rather than fresh market.  Captafol is registered
for control of anthracnose, early blight, late blight, gray
leaf spot, nailhead spot, Septoria leaf spot, and fruit rot.
In California it is also registered for control of black
mold.  A rate of 1.2 to 16 Ib. ai. per acre may be used.
Row crop boom and airblast equipment, and airplane and
helicopter airblast equipment may be used.
                            23

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To control anthracnose captafol is generally applied using
two applications 20 days apart.  To control black mold captafol
is mixed with 30 to 200 gallons of water per acre for ground
application and 10 gallons per acre for aerial application.
Application begins when fruits are well formed and continue
at seven to ten day intervals for up to six applications.
For control of the other diseases 30 to 150 gallons of water
per acre are used for ground applications and 5 to 10 gallons
per acres for aerial application.  In Michigan the flowable
formulation may be applied by center pivot or solid set
irrigation equipment.

Despite captafol's high per acre application cost, it is
still one of the most extensively used fungicides on tomatoes.
In California and the north/northeastern United States, where
most of the processed tomatoes are produced, captafol holds the
second largest market share of base acres treated.  Preliminary
data indicate that captafol usage on tomatoes has declined
slightly in the last two to three years.

Twenty-six alternative fungicides are registered for control
of one or more of the diseases for which captafol is registered.
The major ones include metiram, anilazine, captan, chlorothalonil,
diammonium EBDC, folpet, maneb, nabam, metalaxyl combined
with manozeb, and zineb. For the major diseases early blight,
late blight, and anthracnose, metiram, anilazine, captan,
chlorothalonil, diammonium EBDC, and maneb are the most
viable.

    2.  Preliminary Risk Analysis for Oncogenicity

        a.  Oncogenicity Studies

A two year mouse study (Chevron Chemical Company, 1981,
MRID 00088817) showed both compound and dose-related oncogenic
lesions at the middle and high dose groups.  These lesions
included lymphosarcomas, myeloproliferative disease, harderian
gland hyperplasia, benign harderian gland adenomas, and
hemangiosarcomas.  This compound also produced dose-related
non-oncogenic lesions at all dose levels.  The control group
results were combined with those from a concurrently
run study on another chemical. As a result the Agency classified
this study as supplemental and is requiring that results for
separate controls be submitted.  However, the information
was adequate to calculate a preliminary risk assessment
assuming no neoplasms in the controls, which represents the
worst case.  There was a significant increase in mortality in
the middle and high dose mice, frequently accompanied by
neoplastic lesions.  This preliminary assessment does not
take these early deaths-with-tumors into account.  When the
Agency receives the additional control data, a time-to-tumor
assessment will be conducted.
                               24

-------
A two year rat feeding study (Hazelton Laboratories, 1983,
GS0122044) was also conducted and showed a dose-related
increased incidence of fibroadenomas of the mammary gland and
an increased incidence of neoplastic nodules in the liver of
females.  Not all the animals at the middle and low doses
were subjected to histopathological examination so that the
numbers may not be representative.

A histopathological examination of the previously unexamined
female liver and mammary gland tissues at the middle and low
doses is required.  The information will be included in the
risk assessment conducted during the Special Review.  This
preliminary assessment is based on the results for the high
dose and controls only.

Captafol has oncogenic potential.  The Agency has determined
that captafol meets or exceeds the risk criterion for
oncogenicity in 40 CFR § 162.11(a).

The Agency's Interim Cancer Assessment Guidelines
(41 PR 21402) state that when the Agency judges a chemical to
be a potential human carcinogen, the Agency must estimate its
possible impact on public health at current and anticipated
levels of exposure.  The Agency recognizes that the available
techniques for assessing the magnitude of cancer risk to
human populations based on animal data are crude.  Uncertainties
in the extrapolation of dose response data to very low dose
levels occur.  Also, animals and humans have varying levels of
susceptibility.  Thus, these estimates should be viewed as a
health hazard index that reflects the degree of oncogenic
activity and human exposure to captafol.

        b.  Exposure Analysis and Risk Estimates
                            »
            1)  Non-dietary

The Agency based the applicator exposure analysis on surrogate
data for pesticides with similiar use patterns, label directions,
and use patterns.  Applicator exposure for fruit, citrus,
vegetable, pineapple planting stock, seed treatment, and
wood preservation application were calculated.  An exposure
study on captafol was recently submitted.  If valid, the
information will be used to revise the risk assessment.

For vegetables, fruit, and citrus, the use rates for captafol
are quite variable, depending on the desired number of
applications and the particular requirements for controlling
fungal diseases.  The Agency used 2 Ib. ai. per acre for
ground application.  Captafol is applied to citrus and fruit
using airblast equipment and to vegetables using ground boom
and aerial equipment.  For aerial application, more concentrated
                            25

-------
suspensions are applied.   Generally eight applications are
made per season with the exception of  the use pattern for
sweet corn, which  is treated with 16 applications per season.

For pineapple planting stock,  the planting stock is tank
dipped in a 1.5 percent suspension at  planting and then
planted by hand.   Captafol is  used to  coat seeds using a
commercial seed treating apparatus.  It  is undiluted and in
dry form and applied usually at  a rate of 2 ounces ai. per
100 pounds of seed.

The emulsifiable liquid concentrate formulation is registered
as a wood preservative for use with chromated copper arsenate.
A 0.02 to 0.04 percent ai. solution is used.

The dermal airblast, inhalation  airblast, and ground boom
application were based on  surrogate data from many pesticides
(J. C. Reinert and D. J. Severn,  (?),  GS0122055; J. Davis,
1978, GS0122054; and Versar, Inc., 1984, GS0122057,
respectively).  Aerial, dip, and seed  application were based
on captan (J. Jensen, 1982, GS0122056) and wood preservative
estimates on Position Document 2/3 on  Wood Preservatives
(US EPA, 1980, GS01220058).

The Agency used the following  assumptions to calculate exposure
to captafol:

            i)  The mixer/loader or applicator weighs 60 kg.

           ii)  Neither the mixer/loader nor applicator wears
                protective clothing during application.
                According  to label directions before this
                Guidance Document was  issued, no protective
                clothing was required  except for one formulation.

          iii)  The Agency assumes 100 percent dermal penetration
                A  dermal penetration study was recently submitted
                and is being reviewed.  If valid, the information
                will be used to  revise the risk assessment.

           iv)  The Agency assumes a breathing rate of 1.2 cubic
                meters per hour  for applicators.

            v)  Application to pineapples assumes no inhalation
                or dermal  exposure because captafol is applied
                mechanically as  a dip  and no such exposure
                results.

           vi)  Application to pineapples assumes dermal
                contact twice  a  day with 6 ml of treatment
                suspension while planting seed pieces over 120
                planting days  per year.  No inhalation exposure
                results because  planting is done outdoors.

                               26

-------
          vii)  Application to sweet corn assumes no inhalation
                because no inhalation exposure results to the
                applicator with aerial application.

         viii)  Aerial application did not consider exposure
                for flagmen because they are rarely used.
                Mechanical flagging is the prevalent practice.

           ix)  The seed treatment use combines mixing/loading and
                applying because they are done at the same
                time.

            x)  The wood preservative use assumes no inhalation
                exposure.  The captafol formulation does not
                require mixing, and its application is usually
                metered in with a remote pumping system.  Its use
                is in conjunction with chromated copper arsentate
                (CCA) wood preservative solutions at ambient
                temperatures.  This use is also under presssure
                in an enclosed treatment cylinder.  If added by
                hand, the mixer/loader (applicator) has minimal
                opportunity for inhalation exposure.  Also,
                the excess treatment solution is usually
                pumped back into a storage tank minimizing
                any significant captafol exposure except for
                the wood surface.  Although captafol may have
                a vapor pressure, as opposed to CCA salt
                solutions with no vapor pressure, most treatment
                facilities and the subsequent stacking and
                drying is done outside, not in enclosed spaces.

           xi)  The wood preservative use assumes the mixer/loader
                (applicator)  accidentally comes in contact
                with 6 ml of 30 percent concentrate each day.

The following Table 1 summarizes the exposure for a mixer/loader
and applicator in various use situations:
                           27

-------
Table 1 — ESTIMATION OF EXPOSURE FOR CAPTAFOL USAGE
DURING MIXING/LOADING AND APPLICATION
Use

Airblast
Inhalation
Dermal
Ground Boom
Inhalation
Dermal
Pineapple Dip
Inhalation
Dermal
Aerial —
Sweet Corn
Inhalation
Dermal
Seed
Treatment
Inhalation
Dermal
Wood
Preservative
Inhalation
Dermal

Airblast
Inhalation
Dermal
Ground Boom
Inhalation
Dermal
Pineapple Dip
Inhalation
Dermal
Aerial —
Sweet Corn
mg/hr


5.9
181

7.8
282

0.82
7.68


2
500


0.82
7.68


-
2340


0.06
26

1
18.6

—
180


hr/day hr/yr mg/kg/day
MIXING LOADING

0.5 4
0.5 4

0.5 4
0.5 4

0.5 60
0.5 60


0.5 8
0.5 8


0.25 0.75
0.25 0.75


— —
0.5 50
APPLICATION

4 32
4 32

4 32
4 32

— —
7.5 9.0




0.05
1.5

0.06
2.4

0.007
0.06


0.02
4


0.003
0.03


-
39


0.004
2

0.07
1.2 *

—
3


mg/kg/yr


0.4
12

0.5
20

0.84
7


0.3
64


0.01
0.1



3900


0.03
13

0.6
10

-
360


Inhalation
Dermal
2.3
16
0.4
0.6
                            28

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The preliminary risk estimates representing the worst case
is based on the incidence of neoplastic liver lesions
in rats and lymphosarcomas in mice.  The extrapolation
linearized multi-stage model was used, and estimates were
based on 40 working years over a life span of 70 years.  The
estimates which resulted for mixer/loader and applicator
combined ranged from 3 x 10~2 to 2 x 10~6, with 5 x 10~4 for
the major use sites.

            2)  Dietary

The estimates of dietary exposure to pesticide residues in
the diet are a function of several factors.  These factors
include (1) the residues remaining in or on the commodity;
(2) the percentage of the commodity in the daily diet of
1.5 kilograms; and (3) 60 kilogram body weight.  The residues
are measured in parts per million, and human exposure to
pesticide residues in a commodity is measured in terms of
milligrams of pesticide per kilogram of body weight per day.

The Agency's dietary estimates assume a uniform distribution
of treated crops among the U.S.  population and an average
daily consumption of those crops by individuals.  Although an
individual's exposure could vary considerably depending on
eating habits and geographic location, the values are considered
representative for the total U.S. population over a lifetime.

The Agency calculated worst case dietary exposure based on
the same multi-stage model and incidence of tumors.  This
exposure was based on the TMRC,  which assumes residues are at
100 percent of the tolerance levels.  The actual dietary
exposure may be lower.  The TMRC of 1.46 mg/day is equivalent
to 0.02 mg/kg/day for a 60 kg person.  This results in a
preliminary oncogenicity risk estimate of 2 x 10~4.

    3.  Preliminary Risk Assessment for Ecological Effects

        a.  Ecological Effects Studies

The Agency reviewed several valid ecological effects studies,
which characterize captafol as very highly toxic to fish.
The results of these studies are summarized in Table 2.
                           29

-------
The preliminary risk estimates representing the worst case
is based on the incidence of neoplastic liver lesions
in rats and lymphosarcomas in mice.  The extrapolation
linearized multi-stage model was used, and estimates were
based on 40 working years over a life span of 70 years.  The
estimates which resulted for mixer/loader and applicator
combined ranged from 3 x 10~2 to 2 x 10~6, with 5 x 10~4 for
the major use sites.

            2)  Dietary

The estimates of dietary exposure to pesticide residues in
the diet are a function of several factors.  These factors
include (1) the residues remaining in or on the commodity;
(2) the percentage of the commodity in the daily diet of
1.5 kilograms; and (3) 60 kilogram body weight.  The residues
are measured in parts per million, and human exposure to
pesticide residues in a commodity is measured in terms of
milligrams of pesticide per kilogram of body weight per day.

The Agency's dietary estimates assume a uniform distribution
of 'treated crops among the U.S. population and an average
daily consumption of those crops by individuals.  Although an
individual's exposure could vary considerably depending on
eating habits and geographic location, the values are considered
representative for the total U.S. population over a lifetime.

The Agency calculated dietary exposure based on the same
multi-stage model and incidence of tumors.  This exposure was
based on the TMRC, which assumes residues are at 100 percent
of the tolerance levels.  The actual dietary exposure may be
lower.  The TMRC of 1.46 mg/day is equivalent to 0.02 mg/kg/day
for a 60 kg person.  This results in a preliminary oncogenicity
risk estimate of 2 x 10~4-

    3.  Preliminary Risk Assessment for Ecological Effects

        a.  Ecological Effects Studies

The Agency reviewed several valid ecological effects studies,
which characterize captafol as very highly toxic to fish.
The results of these studies are summarized in Table 2.
                             30

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           Table 2—ACUTE TOXICITY STUDIES FOR FISH
Species
                    Results  for  96-hour
                    in  parts per billion
                                Citation
                                 (MRID)
                 USING TECHNICAL FORMULATIONS
Lepomis macrochius
(Bluegill sunfish)

Lepomis macrochius
(Bluegill sunfish)

Lepomis macrochius
(Bluegill sunfish)

Lepomis macrochius
spomis
Jlueqi
(Bluegill sunfish)

Salmo gairdneri
(Rainbow trout)

Salmo gairdneri
(Rainbow trout)
Carassius auratus
(Goldlife)

Ictalurus punctatus
Channel catfish

Lepomis macrochius
(Bluegill sunfish)

Salmo gairdneri
Rainbow trout)
          158
       (137 - 180.9)

           45
     (35.78 - 56.60)

          212
       (150 - 600)

          230
       (180 - 320)

           27
     (23.81 - 40.48)

          190
     (161.4 - 223.8)

USING FORMULATED PRODUCT

          178
       (146 - 217)

           28


           59
                             21
U.S. EPA, 1980,
   GS0122036

U.S. EPA, 1976,
   GS0122037

U.S. EPA, 1980,
   GS0122038

Thompson et al.,
 1980, 00069607

U.S. EPA, 1976,
   GS0122034

U.S. EPA, 1980,
   GS0122033
                                                 Johnson and Finley,
                                                  1980,  00003503

                                                      same
                                                      same
                                    same
                              31

-------
        b.  Risk Assessment

The Agency is concerned about the effect of captafol on fish
as a result of drift and/or run-off during application to
cranberries, orchards, and tomatoes.  The Agency is also looking
into captafol's effect on endangered species.

Biological monitoring studies (R. W. Felthousen, 1977,
GS0122059 and GS0122060) in New Jersey resulted in fish kills
after the application of captafol at 5 Ib. ai. per acre.
There is a possibility that the entire fish population was
eliminated in one bog.  it cannot be directly proven that the
fish kill resulted from the captafol application because
residue studies were not done.  However, captafol is very
highly toxic to fish, and the fish kill occurred shortly
after application.  The Agency is also aware that cranberry
bogs may be irrigated by sprinkler systems or by flooding,
which would increase the possibility of a future fish kills.
Because many bogs border viable waters, aerial applications
would also increase the chance of fish exposure to captafol
from drift.

The Agency is concerned about the use of captafol in orchards
based on the two incidents in cranberries and based on current
use practices.  In Florida the recommended application rate
to citrus is 16 to 20 Ib. ai. per acre.  The label states
that captafol be used only in orchards with overhead irrigation,
which assures that the fungicide is distributed to the new
leaves and fruit.  This may result in runoff and is of concern
because many groves are located near or on estuaries.

The Agency has estimated possible aquatic environmental
concentrations.  Generally citrus is sprayed using airblast
equipment to achieve proper penetration and coverage.  From
100 to 2,000 gallons of water per acre are used.  Multiple
applications are not recommended at the higher dosage
rates.

The following spray drift model assesses the spray drift
impact on a graduated basis.  (This diagram is not to scale).
This model assumes normal wind under average conditions.
                             32

-------
           wind direction  —>
      17%
50%
83%
0.5 acre
30' 20C
3%) (33?
0.5 acre
)' 1C
i) (6<
0.5 acre
)0' C
5%) (1C
1 acre pond
208.7'
i
)0%)
                                                        208.7
This model assumes that captafol is sprayed over an area
0 to 300 feet from a one acre pond.  This area is divided
into 100 foot intervals consisting of 0.5 acres.  The wind
is blowing from the application site towards the pond.
Under normal circumstances approximately 40 percent of the
spray will not hit the target.  One-half of this off-target
spray can be expected to volatize, which results in 20 percent
of the material remaining.  This material will drift towards
the one acre pond.  The model assumes that the amount of
material drifting will decrease 33 percent with each 100
foot interval.  The percentages from each 100 foot interval
were averaged to determine the percentage of pesticide available
for drift, which are 83%, 50%, and 17%.  Following is a
sample calculation of the amount of drift entering the pond,
assuming 20 Ib. ai . are applied.

   20 Ib. ai. x 20% x 0.5 acres x 83% = 1.66 Ib.
   20 Ib. ai. x 20% x 0.5 acres x 50% = 1.0  Ib.
   20 Ib. ai. x 20% x 0.5 acres x 17% = 0.34 Ib.

   1.66 + 1.0 + 0.34 = 2.90 Ib.

The amount entering the pond spreads throughout the pond,
which is six feet deep.  The expected residues in the
pond are 180 parts per billion (ppb) and exceeds the
An estuary is represented using one-half acre foot of water.
The expected residues using the same procedure and application
rate results in 2,200 ppb, which also exceeds the LC5Q.
                              33

-------
The Agency also estimated the  impact of runoff.  The runoff
model assumes the a six -acre-feet pond (one acre large and
six feet deep) and has a drainage of ten acres with one
percent of the application rate entering the water.  At the
20 Ib. ai. application rate, the expected residues would be
two pounds or 122 ppb.  The fish LC$Q values are approached
or exceeded.

The results of these estimates meet or exceed the Special
Review criterion specified in  40 CFR §§ 162.11(3) (ii) (C) and
The Agency also  is concerned about  the use of captafol on
tomatoes.  In certain areas, growers use a plastic cover to
keep weeds down, hasten maturity  through heat retention,
retain soil fumigants, and  to  shed  rain.  Too much rain causes
the fruit to split or develop  soft  spots, which detracts from
the overall quality of the  product.  When plastic is used, it
covers two feet  on each side of the center, or four out of every
six feet are covered with plastic.  Irrigation is used on all
tomatoes in California, as  well as  in other areas.  The result
of using plastic and irrigation may create a hazard to fish
because of run-off from the plastic into the irrigation system
and into associated waters.

With regard to the protection  of  endangered species from the
use of captafol, the Agency has prepared a request for a
formal consultation with the Office of Endangered Species,
U.S.  Fish and Wildlife Service,  U.S. Department of the
Interior on September 26, 1984 (as  required by Section 7 of
the Endangered Species Act  of  1973, as amended).

This assessment  is preliminary in nature and will be
refined during the Special  Review process, when additional
environmental fate and ecological effects data can be included.
                             34

-------
II.   REQUIREMENT FOR SUBMISSION OF GENERIC DATA

    A.  This portion of the guidance document is a Notice
        issued under the authority of FIFRA Section 3(c)(2)(B)
        and describes, in table format, the data required
        for maintaining the registrability of each product.
        Additionally, a bibliography (Appendix II-l)  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 Section 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 I/ Must Be Submitted.  You may ascertain
        which generic data you must submit by consulting Table A
        at the end of this chapter.  That table shows all the
        generic data needed to evaluate the continued registrability
        of all products, and the dates by which the data must be
        submitted.  The required data must be submitted and any
        necessary studies must be conducted in accordance with
        EPA-approved protocols, the Pesticide Registration
        Guidelines 2/, 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 registration or
        reregistration of certain uses appearing in your labeling,
        you may delete those uses at the time you submit your
        revised labeling.

        Also for certain kinds of testing (generally ecological
        effects), EPA requires the test substance to be a "typical
        formulation," and in those cases EPA needs data of that
    I/ 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)

    2/ The Pesticide Registration Guidelines were reproposed on
November 24, 1982 in 47 Federal Register 53192.

                                 35a

-------
        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 formulations" but not others.  Note;  The "typical
        formulation" 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 IV 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
    11-2] 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 Registration 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.

    2.  Notify EPA that you have entered into an agreement
        with one or more other registrants to jointly
        develop (or share in the cost of developing) the
        data.  If you elect this option, you must notify EPA
        which registrant(s) are parties to the agreement.

    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-3)f/

    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.)

     */ FIFRA Section 3(c)(2)(B) authorizes joint development of
data b~y two or more registrants, and 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.
(Footnote continued at bottom of next page)

                                  35b

-------
    5.  Request voluntary cancellation of the registration(s)
        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 conclusions
        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 registration guidelines or protocols
        contained in the 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.
(Footnote continued from previous page)
     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 not 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)(ill)]; 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.  While the first firm is
not required to agree to jointly develop data, EPA is not required
to force the second firm to engage in economically inefficient
duplicative testing in order to maintain its registration.

                                  .  35c

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                                                        TABLF A
                                        GENERIC DATA REQUIREMENTS FOR CAPTAFOL
Data Requirement
                          Does EPA Have Data
                          To Satisfy This
           V   Use   2/  Requirement?  (Yes,
Composition   Patterns    No or Partially)
                                   Bibliographic
                                     Citation
                                   Must Additional
                                   Data Be Submitted
                                   Under FIFRA Section
                                     3(c)(2)(B)?3/
S158.135 Toxicology

  ACUTE TESTING;

  R.1.-1 - Acute Oral Toxicity - Rat

  81-2 - Acute Dermal Toxicity

  81-3 - Acute Inhalation Toxicity
         -Rat
  81-7 - Acute Delayed
         Neurotoxicity - Hen 9

  SUBCHRONIC TESTING:

  82-1 - 90-Day Feeding -
          Rodent, Non-rodent

  82-2 - 21-Day Dermal 9

  82-3 - 90-Day Dermal 9

  82-4 - 90-Day Inhalation -
          Rat

  82-5 - 90-Day Neurotoxicity-
          Hen/Mammal  9
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
_
Yes
Yes
No
_
GS 0122046
GS 0122046
-
_
    TGAI

   TGAI

   TGAI

    TGAI



    TGAI
A,B
A,B
Partially
No
00093672 (Rodent)
                                                                          No

                                                                          No

                                                                          Yes (6 months)
Yes (Non-rodent)
    (18 months)
                       Yes (18 months)
                                                            35

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                                                        TABLE A
                                        GENERIC DATA REQUIREMENTS FOR CAPTAPOL
Data Requirement
           I/   Use
apposition   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/
§158.135 Toxicology
         (continued)

  CHRONIC TESTING;

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

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

  83-3 - Teratogenicity -           TGAI
          2 species
   83-4  - Reproduction,              TGAI
           2-generation

   MUTAGENICITY TESTING

   84-2  - Gene Mutation              TGAI
                        4

   84-2  - Chromosomal Aberration     TGAI
  84-2  - Other Mechanisms of        TGAI
          Mutagenicity
              A,B
              A,B
              A,B
              A,B
              A,B

              A,B


              A,B
Partially
Partially
Partially
Yes
Partially

Yes


Yes
GS 0122044 (rodent)
GS 0122044 (rat)4
00088817 (mouse)4

05001994 5
GS 0122042 (rat)
GS 0122045 (rabbit)7
GS 0122048 (rabbit)7

GS 0122043
GS 0122040
00046435

GS 0122040 / 0122047
GS 0122046/ 00027544

GS 0122041
      Yes (non-rodent)
          (36 months)
          (rodent)10

      Yes 1°  11
     Yes6 (12 months)
      No
     Yes8 (12 months)

      No


      No
                                                               36

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                                                        TABLE A
                                        GENERIC DATA REQUIREMENTS FOR CAPTAPOL
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
§158.135 Toxicology
         (continued)

  SPECIAL TESTING

  85-1 - General Metabolism
PAI or PAIRA
  85-2 - Domestic Animal Safety 9  Choice
    j

  85-3 - Dermal Absorption       TGAI
A,B
                A,B
Yes
                 No
00061996
00096902
No
                                       Yes (6 months)3
  a/  A dermal absorption study was received by EPA (July 17f 1984);  at the time of the issuance of this
      Standard the study was under Aqency review.
                                                                37

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                                                      TABLE A
                                     GENERIC DATA REQUIREMENTS FOR CAPTAFOL


$158.135 Toxicology
         (continued)

I/ Composition:  PAI = Pure active ingredient: PAIRA = Pure active ingredient, radiolabelled: Choice = Choice of  several
   test substances determined on a case-by-case basis.
2/ The use patterns are coded as follows:  A=Terrestrial, Food Crop; B=tferrestrial, Nbn-Foodr C=Aqauticf Food Crop;
   D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Nbn-Food; G=Forestry; H=Domestic Cutdoor; I=Indoor.
V Data must be submitted no later than indicated in Table A.

4/ These studies have been classified as supplementary and need additional information from the registrant in order
   to determine if they may be used to satisfy the data requirement.

V This study has been classified as supplementary and a study is needed to clarify the equivocal results.

6/ A study in hamsters using two test groups, one dosed on day 7, and the other dosed on day fi of gestation, is needed.

7/ This recently submitted study is currently under review.

8/ A gene mutation test in mammalian cells in culture with and without metabolic activation or utilizing cells with
   metabolically competent cells.

V This test is not required.

10/ Additional histopathology is needed for G3 0122044, chronic rat study.

ll/ Additional information is needed for 00088817t mouse oncogenicity study.
                                                          38

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                                        GENERIC DATA REQUIREMENTS FOR CAFTAFOL
Data Requirement
Compositionb
 Does EPA Have Data
 To Satisfy This
 Requirement?  (Yes,
No or Partially)
Bibliographic
 Citation
Must Additional
Data Be Submitted
Older FIFRA Section
3(c)(2)(B)?c
   EPA REG. NO. 239-2230  (97%T)a

§158.120 Product Chemistry

  Product Identity and Composition;

  61-1 - Product Identity and Diclosure
         of Ingredients                      TGAI
  61-2 - Description of Beginning
         Materials and Manufacturing
         Process                             TGAI
  61-3 - Discussion of Formation of
         Impurities                          TGAI

  Analysis and Certification of Product
  Ingredients

  62-1 - Preliminary Analysis of
         Product Samples                     TGAI

  Physical and Chemical Characteristics

  63-2 - Color                               TGAI
  63-3 - Physical State                      TGAI
  63-4 - Odor                                TGAI
  63-5 - Melting Point                       TGAI
  63-6 - Boiling Point                       N/Ad
  63-7 - Density, Bulk Density, or           TGAI
         Specific Gravity
                         Yes


                         Partially

                         No
                        GS0122030
                        GS0122032
                         No


                         Yes

                         Yes
                         Partially
                         Yes
                         Yes'
                         Yes
                         Yes
                         N/A
                         No
                        GS0122028, GS0122030
                        GS0122029
                        GS0122029
                        GS0122029
                        GS0122029
                         Yes
                         No
                         No
                         No
                         No
                         No
                         No
    a The 97% technical (T) also serves as a manufacturing-use product.
    b Composition:  TGAI = technical grade of the active ingredient: PAI = pure active ingredient.
    c Data must be submitted no later than 6 months from the date of this Standard.
    d Not required because the <*7% technical is a solid at room temperature.
                                                             39

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                                                         TABLE A
                                        GENERIC DATA REQUIREMENTS FOR CAPTAFOL
Data Requirement
Composition13
 Does EPA Have Data
 To Satisfy This
 Requirement?  (Yes,
No or Partially)
Bibliographic
 Citation
Must Additional
Data Be Submitted
Under FIPRA Section
3(c)(2)(B)?c
   EPA REG. NO. 239-2230  (97%T)a

S158.12Q Product Chemistry (continued)

  63-8 - Solubility
  63-9 - Vapor Pressure
  63-10 - Dissociation Constant
  63-11 - Octanol/ Water Partition
          Coefficient
  63-12 - pH
  63-13 - Stability

  other Requirement;
  64-1 - Submittal of Samples
   TGAI or PAI
   PAI
   PAI

   PAI
   TGAI
   TGAI
   N/A
      Partially
      No
      No

      Nb
      No
      Yes '
      N/A
GS0122051
GS0122050
       Yes
       Yes
       Yes

       Yes
       Yes
       No
                         No
  a The 97% technical (T) also serves as a manufacturing-use product.
  b Composition:  TGAI = technical grade of the active ingredient:  PAI = pure active ingredient.
  c Data must be submitted no later than 6 months from the date of this Standard.
                                                            40

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                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FOR CAPTAFOL
Data Requirement
 Composition1/
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

 171-4 - Nature of Residue (Metabolism)

       - Plants                         PAIRA
                          Partially
                     See Footnote A
                      Yes3
       - Livestock


171-4 - Residue Analytical Method

      - Plant residues
      - Animal residues
        Presently there are
        no established tolerances

171-4 - Storage Stability Data
PAIRA and plant
  metabolites
  Pure Analytical
  Standards and
  metabolites

  Pure Analytical
  Standard and
  metabolites

    PAI
   Partially
See Footnote B
     Yes4
   Partially
   Partially
   Partially
See Footnote C
See Footnote C
    00091274
    Yes6
     Yes?
A.  Bibliographic Citations:  00025129, 00025130, 0009619, 00096916, 00072884, 0081808 and 05003661.

B.  Bibliographic Citations:  00096829, 00096830, 00025952, 00025119, 00025120, 00025124, 00025127, 00061996,
                              00053240 and 00096902.

C.  Bibliographic Citations:  00096847, 00096848, 00096843, 00091215, 00091214, 0052318, 0031709, 00025123,
                              00096911, 00025123 and 00025133
                              GS0122001, GS0122002, GS0122003, GS0122004, GS0122005, GS0122006, GS0122052
                              GS0122053
                                                       41

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                                                       TABLE A
                                              DATA REQUIREMENTS FOR CAPTAFOL
Data Requirement
Composition1/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)	
Bibliographic
  Citation
Must Additional
Data Be Submitted
Under PIPRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
         (continued)

171-4 - Magnitude of the Residue-
         Residues Studies for Each
         Food Use

      Citrus Fruit Group?
         Citrus Fruits                  EP

      Pome Fruits Grouph
         Apples                         EP
         Pears                          EP

      Stone Fruits Group*
         Apricots                       EP
         Cherries^ Sour and Sweet       EP
         Nectarines                     EP
         Peaches                        EP
         Plums  (Fresh Prunes)           EP

      Small Fruit and Berries GroupJ
         Blueberries                    EP
         Cranberries                    EP
         Strawberries                   EP
                         Partially
                         Partially
                         None
                         Partially
                         Partially
                         Partially
                         Partially
                         Partially
                         Partially
                         Partially
                         None
                         GS0122012
                         GS0122007
                         GS0122008
                         GS0122009
                         GS0122010
                  00096828 and GS0122011
                   Same as for Apricots
                   Same as for Apricots
                         GS0122021
                  00096889 and GS0122014
                      Yes12


                      Yes8
                      Yes
                      Yes11
                      Yes18
                      Yes21
                      Yes23
                                           Yes1*
                                           Yes
                                                        42

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                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FOR CAPTAPOL
Data Requirement
Composition1/
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)

171-4 - Magnitude of the Residue-
         Residues Studies for Each
         Food Use

     Tree Nuts Group^
         Macadamia Nuts                 EP
         Pecan Nutmeats (Shells removed)
           (Pending)

     Cereal Grains Group1
         Corn, fresh (including
           sweet, kernels plus cobs
           with husks removed)          EP

     Other Raw Agricultural Conmodities
         Coffee beans (green) (Pending)

         Peanuts, meats (hulls removed) EP

         Peanuts, hulls                 EP

         Pineapples                     EP

         Sugarcane                      EP

         Taro (corm)                    EP
                         Partially
                         Partially
                         Partially

                         Partially

                         Partially

                         None

                         Partially
                         GS0122015
                      Yes16
                         GS0122013
                      Yes13
                         GS0122017
                         GS0122018
               Same as for Peanuts Meats

                         GS0122020
                         GS0122025
                      Yes1*

                      Yes1?

                      Yes22

                      Yes
                                                          43

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

171-4 - Magnitude of the Residue-
         Residues Studies for Each
         Food Use

      Root and Tuber Vegetable Group3
         Carrots (Pending)
         Potatoes                       EP

      Bulb Vegetable Groupb
         Onions                         EP

      Legume Vegetable
         (Succulent or Dried) Group0
         Soybeans (Pending)

      Foliage of Legume Vegetable
        Grcupd
         Soybean Forage and Hay (Pending

      Fruiting Vegetables (Except
        Cucurbits Group6
         Tomatoes                       EP

      Cucurbit Vegetable Groupf
         Cucumbers                      EP
         Melons                         EP
                         Partially


                         Partially
                         GS0122022
                         GS0122023
                         GS0122050
                         GS0122019
                         Partially
                         Partially
                         Partially
                         GS0122025
                         GS0122026
                         GS0122027
                          00096817
                         GS0122016
     Yes24


     Yes20
     yes
        26
     Yesi?
                                                      44

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                                                       TABLE A
                                       GENERIC DRTA REQUIREMENTS FOR CAPTAPOL

§158.125 Residue Chemistry (continued)


     a.  Residue data are required for two additional members of eht group (radish and sugar beet).  Note that
         data in support of a proposed tolerance for captafol residues in or on carrots are currently under review.

     b.  Residue data are required for one additional member of this crop group (garlic, leek or shallot).

     c.  Residue data are required for the three representative commodities of this group: beans (one succulent
         and one dried variety);  peas (one succulent and one dried variety) and soybeans; captafol formulations
         are currently not registered for use on any member of this crop group (use on soybeans has been
         proposed.

     d.  Same as c above.

     e.  Residue data are required for one additional member of this group (peppers).  IR4, Rutgers University
         PP No. OE2365 (099439) submitted data pertaining to residues of captafol per se in or on peppers; however
         the data will not satisfy group tolerance requirements because no data pertaining to residues of THPI
         were submitted.

     f.  Residue data are needed for an additional representative member of this crop group (summer squash).
         Currently, captafol formulations are registered for use only on cucumbers and melons.

     g.  A tolerance of 0.5 ppm has been established for the residues of captafol in or on citrus fruits.
         Additional data are required to fully support this group tolerance.
                                                      45

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                                                       TABLE A
                                       GENERIC DATA REQUIREMENTS FOR CAPTAPOL
§158.125 Residue Chemistry (continued)
     h.  A crop group tolerance is not appropriate, as additional data are required for the representative
         commodities apples and pears.  A tolerance has been established for apples but not for pears.

     i.  A crop group tolerance is not appropriate because the tolerances established for members of this crop
         group differ by more than a factor of five (2-50 ppm).  Data are required in support of established
         tolerances for representative crops.

     j.  Crop group tolerance is not appropriate because residue data on captafol per se and its THPI metabolite
         are required for a Rubus spp., grape, strawberries, blueberries and cranberries.  Also, the established
         PHI for blueberries (21 days) differ significantly from that of cranberries (50 days).

     k.  A crop group tolerance is not appropriate because residue data for three representative connodities
         (almond, pecan and English walnut) are required.  Residue data have been submitted for almond, but no
         data on the THPI metabolite were submitted.  A petition to establish a tolerance for residues of
         captafol per se in or on pecans (PP No. 6F1795) is currently under review.

     1.  A crop group tolerance is not appropriate because: 1.  Additional data are required to support the
         established tolerance for fresh corn,  2. Registered uses on field corn, sorghum and rice (seed
         treatment only) differ significantly from uses on sweet corn (seed treatment in ID and PL and
         multiple foliar applications in FL;  3.  Residue data and tolerance proposals are required for
         rice, sorghum, and field corn;   4. Residue data are required for one additional member of this
         crop group (wheat).
                                                       46

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                                                       TABLE A
                                       GENERIC DATA REQUIREMENTS FOR CAPPAPOL
S15R.125 Residue Chemistry (continued)
I/  Composition: TGAI = Technical grade of the active ingredient?  PAIRA = Pure active ingredient, radiolabeled;
    TEP = Typical end-use product; EP = End-use product.

2/  Data must be submitted no later than 12 months from the date of receipt of this Standard.

3/  The metabolism of captafol in plants is not adequately understood due to the lack of sufficient data on this
    topic.  The following additional data are required:

         The uptake, distribution, and metabolism of carbonyl-labeled [^c]captafol in representative crops,
         preferably a tree fruit, potatoes, tomatoes and corn following foliar and soil applications.  Sampling
         intervals through at least 21 days post-treatmeent must be included.  The identities and quantities of
         residues in or on mature plant parts must be determined in order to elucidate the terminal residues.
         Residue identities must be confirmed by a method such as GC, HPLC, and/or mass spectrometry.

4/  Presently, the metabolism of captafol [cis-N-[(l,2,2-tetrachloroethyl)thio]-4-cyclohexene-l,2-dicarboxijnide(I)]
    in ruminants is adequately understood.  However, the available data for poultry metabolism of captafol are
    inadequate; thus the residues of concern in poultry and eggs cannot be ascertained.  The following additional
    data are required:

         Poultry (laying hens) must be dosed with carbonyl-labeled [14C]captafol daily for at least 3 days.  Resi-
         dues must be characterized in tissues (including muscle,  liver, kidney, fat, heart, gizzard, and skin) and
         eggs.  Animals must be sacrificed within 24 hours of the last 14c-
-------
         Data demonstrating the stability of captafol and its tertrahydropthalamide (THPI) metabolites  in or on
         representative crops (such as apples, cherries, citrus, potatoes, tomatoes, and sweet corn) and animal
         products (meat, milk, and eggs) stored at subfreezing temperatures for intervals approximating the
         storage intervals of treated samples used to determine the magnitude of the residue.

8/  Apples.  Residue data involving levels of captafol per se and its THPI metabolite in or on apples following
    delayed or dormant spray application using either the 4 Ib/gal FIG or 80% WDG formulation at 20 Ib  ai/A from
    tests conducted in midwestern states.

9/  Apricots.  Residue data from apricots treated with twice with dormant applications of the 80% WP at 6.4 ai/A,
    once in the fall and again in early spring at bud swell.  Captafol and THPI residues should be determined
    separately for fruit samples taken at their normal time of harvest.  The studies should be conducted in CA,
    OT, and WA.  Note that other metabolites may need to be sought if the requested plant metabolism studies reveal
    the presence of other residues of concern.

10/  Blueberries.  Residues of captafol and its THPI metobolites in or on mature blueberries following multiple
     treatment with the 4 Ib/gal F1C or 80% WDG at 4 Ib ai/A.  Applications should begin at the early green tip
     stage and continue at 1-week intervals throughout petal fall after which application should continue at 10-day
     intervals until 21 days prior to harvest.  Tests should be conducted in ME, MI, and NJ.

     Residue data for captafol and THPI (analyzed and reported separately) from sour cherries harvested at their
     normal time of maturity after being subjected to the following treatment regime: (i) four foliar treatments
     during the blooming period (treatments spaced 2 days apart, ending at petal fall) with the 4 Ib/gal F1C
     sprayed to runoff at 1 Ib ai/100 gal until normal fruit maturity.  The studies should take place in
     MI  (65.4%), NY (6.2%) and OR (3.7%); percentages of U.S. sour cherry production contributed by states shown
     parenthetically.

ll/  Residue data for captafol and THPI (analyzed and reported separately) from sweet cherries harvested at normal
     maturity after four foliar treatments during the blooming period (treatments spaced 4-7 days apart, ending at
     petal fall) with the 80% WP or the 4 Ib/gal F1C sprayed to runoff at 1.6 Ib ai/100 gal (400 gal spray/A).  The
     studies should take place in CA or OR.
                %

     In addition, since the metabolism of captafol in plants is not adequately understood (see Nature of the Residue
     in Plants section), data for additional metabolites of captafol may be required if the requested studies
     discover residues of concern other than captafol and THPI.

12/  Residue data from orange products (dried pulb, peel, oilr molasses, juice) processed from whole oranges bearing
     measurable, weathered residues.  Exaggerated rates of applications only may be required to obtain such initial
     residues.  Captafol and THPI should be quantified separately.

                                                       48

-------
     Residue data concerning oranges (in FL) treated from late dormant to tight bloom with the 4 Ib/gal or 80% WDG
     at 20 Ib ai/A followed by treatments from tight bloom to petal fall at 10 Ib ai/A.  Whole mature fruit should
     be harvested and analyzed for oaptafol per se and THPI separately.  Other metabolites may need to be determined
     if the required plant metbolism data indicate such a necessity.

13/  Data reflecting residues of captafol and THPI in or on sweet corn (kernels plus cob with husks removed) grown
     from seed treated with the 4 Ib/gal F1C formulation at 4 oz ai/100 b of seed and treated with  15 aerially-
     applied foliar applications (made 4 days apart) of the 4 Ib/gal F1C or 80% WDG formulation at 1 Ib ai/A.
     Samples must be harvestd 5 days after the last foliar applications.  Tests must be conducted in Fl.

     Since seed treatement is no longer considered a non-food use for captafol, label restrictions prohibiting
     feeding or grazing of treated crops and limiting use to corn grown for fresh market should be added to both
     24(c) labels (ID80005000 and FL8006400);  alternatively, data reflecting residues in or on sweet corn forage
     and cannery waste following seed treatments, and appropriate tolerance proposals must be submitted.

14_/  Residues of captafol and its THPI metabolite in or on cranberries 50 days after the last of three foliar
     applications made at   10-day intervals with the 4 Ib/gal EC or the 80% WDG formulation at 5 Ib ai/A,
     Tests should be conduceted in MS and WI.

15/  Residue data involving captafol residues (captafol per se and its THPI metabolite ) in or on cucumbers as a
     result of a foliar spray when first true leaves appear and at weekly intervals thereafter using either the
     80% WP, 80% WDG, or 4 Ib/gal F1C formulation at 1.6 ai/A from tests conducted in CA and/or TX.

     Residue data involving captafol residues (captafol per se and its THPI metabolite) in or on cucumbers following
     a single spray application of the 4 Ib/gal F1C or 80~%~WDG at 3.25 Ib ai/A directed to the bed soil after
     the last cultivation or when vines begin to run from tests conducted in southeastern states.

16_/  Residue data for captafol and THPI (analyzed and reported separately) in or on macadamia nutmeats after 16
     foliar treatments made twice weekly during the 8-week period in February and March.  The studies should be
     done in Hawaii.

IT/  Residue data involving residues of captafol (captafol per se and its THPI metabolite) in or on any melon
     variety other than watermelon as the result of a spray application of the 80% WP, 4 Ib/gal F1C, or 80% WDG
     formulation at 2.5 Ib ai/A (using 100-150 gal spray/A) beginning when first true leaves appear and repeated
     at weekly intervals thereafter from tests conducted in CA and TX.

     Residue data involving residues of captafol (captafol per se and its THPI metabolite) in or on watermelons
     from aerial applications of the 80% WDG at 2.5 Ib ai/A (using 5 gal spray/A) beginning when plants start
     to vine and repeated at 5- to 10-day intervals from tests conducted in any southeastern (FL, GA, or SC) and
     western (CA and TX) location.

                                                        49

-------
     Residue Data involving residues of captafol (captafol per se and its THPI metabolite) in or on watermelons
     fron aerial applications of the 4 Ib/gal F1C at 2.5 Ib ai/A (using 5 gal spray/A) beginning when plants
     start to vine and at 5- to 10-day intervals thereafter from tests conducted in TX.  Alternatively, this state
     label could be cancelled.

     Residue data involving levels of other captafol metabolites may also be required if the requested plant meta-
     bolism data show other residues of concern to be present in significant amounts in mature plants.

18/  Same as with Apricots.

19/  Data reflecting residues of captafol and THPI in or on peanut nutmeats and hulls 14 days after the last of
     12 foliar applications (made 10 days apart) of the 80% WDG formulation at 1.6 Ib ai/A.  Both aerial and ground
     applications must be represented.  Plants must be grown from seed treated with one of the registered D form-
     ulations at 0.2 Ib ai/100 Ib of seed.  Tests must be conducted in peanut production regions in FL (4%),
     GA (42%) TX (10%), and VA (8%); percentage of 1981 peanut crop production is given in parentheses (preliminary
     figures; Agricultural Statistics, 1982, p. 126).  If GA can represent both AL (15%) and NC (14%), then   93%
     of the peanut production area will be represented.

     Data reflecting residues of captafol and THPI in meal, crude oil, refined oil, and soapstock processed from
     nutmeats having measurable weathered residues.  If residues are found to concentrate in any of these processed
     products, appropriate food/feed additive tolerances must be proposed.

20/  Residues of captafol and its tetrahydrophthalimide (THPI) metabolite in or on onions (dry bulb) on the day
     of the last of 12 weekly applications of the 4 Ib/gal F1C or the 80% WDG formulation at 1.25 Ib ai/A.  Tests
     should be conducted in CD (10%), ID (8%), or OR (14%), MI (8%), and NY (13%);  percent contribution to annual
     U.S. dry bulb onion production is given in parenthesis.

     Residues of captafol and THPI in or on green onions on the day of the last of 8-10 foliar applications of the
     4 Ib/gal FLC or 80% WDG applied weekly at 1.25 Ib ai/A.  Tests should be conducted in CA (40%) and TX (50%);
     percent contribution to annual U.S. green onion production is given parenthetically.  Alternatively the labels
     and commidity|definition could be changed from "onions" to "onions (dry bulb)."

     Note that other metabolites of captafol may need to be sought in the above requested studies if the plant meta-
     bolism studies reveal additional residues of concern.

21/  Sams as with Apricots.

22/  Residues of captafol and its THPI metabolite in or on whole pineapple fruits and forage grown from slips
     treated with a single dip application at 0.125 Ib ai/gal (31.25 Ib ai/A) followed by eight foliar spray treat-
     ments at 8 Ib ai/A with either the 80% WP, 80% WDG, or the 4 Ib/gal F1C formulation.  Tests should be conducted
     in HI.
                                                          50

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     Determination of residues (captafol and its THPI metabolit) in juice and bran processed form captafol-treated
     pineapple bearing detectable, weathered residues of captafol.

23/  Residue data for captafol and THPI (analyzed and reported separately) from dried prunes processed from plums
     (fresh prunes) bearing measurable weathered residues.  Exaggerated rates may be required to obtain such residue
     levels.

     A tolerance for dried plums should be proposed based on this data, if necessary.

24/  Combined residues of captafol and THPI in or on whole potatoes harvested on the day of the last of 16 weekly
     applications of either a F1C, WDG or WP formulation at 1.6 Ib ai/A.  Tests must be conducted in CA, ID, ME, and
     WI.

     Residues of captafol per se and its THPI metabolite in dried potatoes, potato chips, and granules processed
     from potatoes containing tolerance-level or above (>0.5 ppm ) weathered residues of captafol.

25/  Data reflecting residues of captafol and THPI in or on taro root (corn) and foliage 11 weeks after the last
     of 23 foliar sprays (applied 7 days apart) with the 80% WDG formulation at 1.6 Ib ai/A.  Tests should be con-
     ducted in HI.

26/  Residue of captafol per se and its THPI metabolite in or on mature tomatoes harvested on the day of the last
     of 10 foliar applications (using ground and aerial equipment) with either the 4 Ib/gal F1C, the 80% WP or the
     80% WDG formulation at 2.5 Ib ai/A; treatments are to begin when fruit is well formed and continued at 7-day
     intervals.  Tests should be conducted in CA and FL using both aerial and ground equipment.

     Residues of captafol per se and its THPI metabolite in or on mature tomatoes which received a single foliar
     application (at fruit formation) with the 4 Ib/gal F1C or the 80% WDG formulation at 16 Ib ai/A and (in a
     separate test with either the F1C or the WDG) two foliar applications, separated by 20 days, at 8 Ib/A.  Tests
     should be conducted in CA and FL using either ground or aerial equipment for application.

     Residue data from greenhouse tests in which a single soil drench treatment with the 4 bl/gal F1C formulation
     is made at 24 Ib ai/A 14 days prior to planting.  Residues of captafol per se and THPI must be determined.
                                                      51

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              TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAFOL
Data Requirement
158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradation
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
Composition!/
TGAI or PAIRA

TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA

163-1 - Leaching and>% TGAI or PAIRA
Adsorption/Desorption
163-2 - Volatility (Lab) TEP
1fi-a_-J _ \7r>la4-i1 ii-xr SPiol/n TRD
Use 2/
Pattern
A,C,E

A,C
A,
A
A,E
A
C
C
A,E
A,E
a_R
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
No 	

No 	
No 	
No 	
Partially4/ 00096916
Partially5/
Partially6/ 00026453
No 	 	
Partially7/ 00096917
00096972
Mr> 	 _—
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
Yes (6 months)

Yes (6 months)
Yes (6 months)
Yes (6 months)
Yes (24 months)
No
Yes (24 months)
Yes (24 months)
Yes7 (6 monts)
Yes (6 months)
Veio If. T¥v\nH-»c \
                52

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                                                          TABLE A
                                            GENERIC DATA REQUIREMENTS FOR CAPTAFOL
      Data Requirement
Composition^/
             Does EPA Have Data
             To Satisfy This
 Use 2/      Requirement? (Yes,
Pattern	No or Partially)
              Bibliographic
                Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
158.130 Environmental Fate
        (continued)

   DISSIPATION STUDIES-FIELD;

   164-1 - Soil

   164-2 - Aquatic (Sediment)
           Water
   TEP

   TEP
   TEP
   C
   C
No

No
No
  Yes (24 months)

  Yes (24 months)
   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
   TEP
                                                           No
   165-5 - In Aquatic Non-Target
            Organisms

   Reentry Studies
   TEP




  PAIRA


   TEP


   TEP

TGAI or PAIRA

    TEP
   C

   A,C
                     NO
                   partially^/
  No


  No

  No
                 00096919
  Yea?/ (36 months)



  Yes (24 months


  Yes (24 months)


  Yes (24 months)

  Yes (24 months)
                                                                             (24
I/ Composition;  TGAI = Technical grade of the active ingredient; PAIRA - Pure active ingredient, radiolabelled;
   TEP = Typical end-use product.
2/ The use patterns are coded as follows:  A=
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                                                          TABLE A
                                          GENERIC DATA REQUIREMENTS FOR CAPTAFOL

4/  Study 00096919 partially fulfills data requirements by providing information on  the rate of  carbonyl-labeled [14C]
    captafol degradation a loamy sand soil and on the identification, formation and  decline of  [l^C]  captafol degradate
    in aerobic soil.  The study did not provide information on the 4 cyclohexene ring opening  (degradation)  in  aerobic
    soil.  An additional aerboic soil metabolism study is required utilizing 4 cyclohexene ring  labeled  captafol as the
    test substance.  The study must be conducted as the same soil type and at the same concentration, temperature and
    moisture as the study in which carbonyl-labeled captafol was used as the test substance.

5/  Data fron an anaerobic soil metabolism study need not be submitted if data from  the anaerobic aquatic metabolism study
    study described in §162.3 of this subdivision have been submitted.  An anaerobic aquatic metabolism  study has been
    submitted which partially fulfills data requirements.

6/  One study has reviewed, 00026453, and it is scientifically valid.  This study partially fulfills data requirements by
    providing information on the rate of anaerobic aquatic degradation of carbonyl-labeled  [^C] captafol in a  loamy
    sand soil, and on the identification, formation and decline of [l^C]! captafol degradates in water plus  loamy sand.
    The study did not provide information on the 4-cyclohexene ring opening (degradation) in anaerobic water plus loamy
    sand.  An additional anaerobic aquatic metabolism study is required utilizing 4-cyclohexene  ring-labeled captafol as
    the test substance.  The study must be conducted using water plus sediment obtained from and representative of that
    found at the intended aquatic use site.  This study must be submitted in order to waive the  anaerobic soil  data
    requirements.

7/  Two studies partially fulfill data requirements by providing data on the mobility of captafol residues aged in sandy
    loam soil 20-30 days, however the aged captafol residue were not characterized (00096917), and on the mobility of
     [14c]captafol in silty clay loam, sandy loam, clay, and clay loam soils (00096972).  Additional data are needed on
    the mobility of aged captafol residues (captafol) and its degradates in soil.  For the study of pesticide degradates
    mobility, captafol must be aged for 30 days or one half-life using appropriate laboratory conditions, soil  sampling
    protocols, and analyses.  The degradates must be identified.  This will fulfill  data requirements for terrestrial,
    food crop use patterns.  To fulfill the data requirements for greenhouse food crop use patterns, batch equilibrium
    (adsorption/desorption) studies are required on a minimum of four soils.  The soils selected must be soils  such as
    sand (agricultural), sandy loam, silt loam, clay or clay-loam, each having a pH  within a range of 4-8.   Batch equili-
    brium (adsorption/desorption) studies on one aquatic sediment obtained from or representative of the of  the proposed
    aquatic use area required to fulfill the aquatic food, crop use patterns.
                        '%
    Based on leaching and aerobic soil metabolism studies data requirements, captafol is immobile in soil varying in
    texture from clay to sandy loam.  The immobility of captafol in soil and its degradation in  soil are expected to
    result in a low potential for ground water contamination by captafol.  However,  aged [l^c] captafol  residues are
    mobile in sandy loam, but as was true for the parent compound, the degradation of captafol degradates is expected to
    reduce the potential for groundwater contamination by captafol degradates.

    The Agency is concerned about the contamination of ground water by captafol and  its metabolites.  Data required  for
    the evaluation of the potential for contamination of ground water are being required on an accelerated basis.

                                                            54

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                                                           TABLE A
                                           GENERIC DATA REQUIREMENTS -FOR CAETAFOL


 8/  The data requirements for Long Term Soil Dissipation Studies will be based on the results of Aerobic Soil Metabolism
     and Terrestrial Field Dissipation Studies.

 9/  Study 0009691 partially fulfills data requirements by providing data on the uptake of aged [14C]captafol residues
     by rotated carrots (roots and tops) grown under confined conditions.  Additional studies are needed providing infor-
     mation on the identity of [-^C] captafol residues ages in a sandy loam soi by 2 rotated small grain and rotated
     leafy vegetable.  The results of this study (00096919) indicate that field accumulation studies on rotational crops
     are required to establish rotation restriction intervals or to determine if tolerance are needed for rotational
     crops.

10/  The Agency is imposing a 24-hour reentry interval pending receipt and evaluation of reentry data.
                                                             55

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                TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAFOL
Use V
Data Requirement Composition*/ Pattern
$158.145 Wildlife and
Aquatic Organisms
Avian and Mammal Testing
71-1 Acute Avian Oral Toxicity TGAI A,C
71-2 Acute Avian Dietary Toxicity THAI ArC
a. Waterfowl
b. Upland game
71-3 Wild Mammal Toxicity 	
71-4 Avian Reproduction TGAI A,C

71-5 Simulated and Actual TEP A
Field Testing on Mammals
and birds
Aquatic Organisms Testing
72-1 Acute Freshwater F|sh ToxicityTGAI A,C
a. Warmwater

TEP A,C
c. Coldwater TGAI A,C



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


Yes
Yes
Yes
Yes

No


Yes

Yes
Yes



Bibliographic
Citation


00096964*
GS0122039*
00096965*

00030479*
00041447*



GS0122036*
GS0122037*
GS0122038*
00003503*
GS0122034*
GS0122033*
GS0122035*
00069607*
Must Additional
Data Be Submitted
Under FIFRA Secti<
3(c)(2)(B)23/


No
NO

NO
No

Reserved^


No

No
No



                   56

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                                                          TABLE A
                                          GENERIC DATA REQUIREMENTS FOR CAPTAPOL
      Data Requirement
Composition!/
             Does EPA Have Data
             TO Satisfy This
Use ?/       Requirement? (Yes,
Pattern	No or Partially)
             Bibliographic
               Citation
                                                                                                     Must Additional
                                                                                                     Data Be Submitted
                                                                                                     Under PIPRA Section
72-2  Acute Toxicity, Freshwater
      Invertebrates
72-3  Acute Toxicity, Estuarine
      and Marine Organisms

         Oyster

         Shrimp

         Marine fish

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

72-6  Aquatic Organisms
      Accumulation

72-7  Simulated or Actual Field
      Testing-Aquatic Organisms
    TGAI

    TEP


    TGAI

    TEP
    TGAI,PAI
    TGAI,PAI
    TEP
  A,C

  A,C


  A,C

  A,C
  AfC




  A,C


  A,C
Yes

Yes


No

No
No
No
00062907*
00003503*
00097842**
No
                    Reserved**
                    Reserved?



                    Reserved?


                    Reserved7
I/  Composition:  TGAI = technical grade of the active ingredient: PAI = pure active ingredient; TEP =  typical  end-use
    product.

2/  The use patterns are coded as follows:  A = terrestrial non-food crop: C = Aquatic  food  crop? D = aquatic non-food
~~   crop? E = greenhouse food crop; P = greenhouse non food crop: G = Forestry: H = domestic outdoor: I =  indoor.

3/  Data must be submitted no later than 6 months after  the publication of this standard.

                                                            57

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                                                          TABLE A
	f	GENERIC DATA RT^TIRKMEKTS FDR CAPTAFOL
Footnotes  (continued)
4/  Pending results of environmental fate data.
5/  Uses such as citrus  (with acreage in excess of 300,000 acres in coastal counties).
6/  Data may be required to support such uses as citrus pendinq the results of environmental fate data.
7/  Data may be required pending the result of environmental fate data.
*   Study fulfills requirements on its own.
**  Study in conjunction with another study fulfills requirements.
                                                            58

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III.  REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA

    Note:  This Section applies only to manufacturing-use
products, not end-use products.

    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" identified by EPA concerning your product.  Under
the authority of FIFRA Section 3(c)(2)(B), EPA has determined
that you must submit these data to EPA in order to register or
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 determine which
product-specific data you must submit.  This can be done by
examining the entries in the column of those tables entitled
"Must Data Be Submitted Under S3(c)(2)(B)."
     ^J Product specific data pertains to data that support the
formulation which is marketed; it usually includes product chemistry
data and acute toxicology data.
                              59

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                                                         TABLE B
                  PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CAPTAFOL
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)?c
   EPA REG. NO. 239-2230  (97%T)a

$158.120 Product Chemistry

  Product Identity and Composition;

  61-1 - Product Identity and Diclosure
         of Ingredients                      TGAI
  61-2 - Description of Beginning
         Materials and Manufacturing
         Process                             TGAI
  61-3 - Discussion of Formation of
         Impurities                          TGAI

  Analysis and Certification of Product
  Ingredients

  62-1 - Preliminary Analysis of
         Product Samples                     TGAI

  Physical and Chemical Characteristics
                                                                   Yes


                                                                   Partially

                                                                   No
                        GS0122030


                        GS0122032
                                                                   Partially
                                           GS0122028, GS0122030
    a The 97% technical  (T) also serves as a manufacturing-use product.
    b Composition:  TGAI = technical grade of the active ingredient: PAI = pure active ingredient.
    c Data must be submitted no later than 6 months from the date of this Standard.
                                                                    No


                                                                    Yes

                                                                    Yes
                                                 Yes
63-2
63-3
63-4
63-5
63-6
63-7

- Color ,„
- Physical State
- Odor
- Melting Point
- Boiling Point
- Density, Bulk Density, or
Specific Gravity
TGAI
TGAI
TGAI
TGAI
N/A^
TGAI

Yes
Yes
Yes
Yes
N/A
No
/
GS012202Q
GS0122029
GS0122029
GS0122029



No
No
No
No
No
No


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                                                         TABLE B
                  PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CAPTAFOL
Data Requirement
Composition*3
 Does EPA Have Data
 To Satisfy This
 Requirement?  (Yesf
No or Partially)
Bibliographic
 Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?c
   EPA REG. NO. 239-2230  (97%T)a

$158.120 Product Chemistry (continued)

  63-R - Solubility
  63-Q _ vapor Pressure
  63-10 - Dissociation Constant
  63-11 - Octanol/ Water Partition
          Coefficient
  63-12 - pH
  63-13 - Stability

  other Requirement;
  64-1 - Submittal of Samples
   TGAI or PAI
   PAI
   PAI

   PAI
   TGAI
   TGAI
   N/A
      Partially
      No
      No

      No
      No
      Yes
      N/A
GSni22051
GS0122050
       Yes
       Yes
       Yes

       Yes
       Yes
       No
                         No
  a The 97% technical (T) also serves as a manufacturing-use product.
  b Composition:  TGAI = technical grade of the active ingredient;  PAI = pure active ingredient.
  c Data must be submitted no later than 6 months from the date of this Standard.
                                                            61

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                                                        TABLE B
                PRODUCT SPECIFIC DATA REQUIREMENTS FOR MAMFACTURING-USE PRODUCTS CONTAINING CAPTAFOL
Data Requirement
Composition"
                                                 V
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
§158.135 Toxicology
ACUTE TESTING
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Acute Inhalation Toxicity
-Rat
- Primary Eye
Irritation - Rabbit
- Primary Dermal
Irritation
- Dermal Sensitization
MP
MP
MP
MP
MP
MP
Yes
Yes
No
Yes
Yes
Yes
GS 0122046
GS 0122046
-
GS 0122049
00087538
00014690
No
No
Yes (6 months)
No
No
No
                                                            62

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                                                      TABLE B
              PRODUCT SPECIFIC DATA RETIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CAPTAFOL


$158.135 Toxicology
         (continued)


I/ Composition:  MP = Manufacturing-use product.
2!/ Data must be submitted no later than 6 months from the date of receipt of this Standard.
                                                          63

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IV.  SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION

  - Note:  This section applies to end-use products only to the
extent described under Section II of this document.  Otherwise,
the following information pertains exclusively to manufacturing-
use products.

    The Agency requires applicants for registration or reregistra-
tion to ensure that each label (1) contains accurate, complete,
and sufficient instructions and precautions, reflecting the
results of data concerning the product and its ingredients, and
(2) incorporates labeling format and terminology which are suffi-
ciently standardized to avoid user confusion.

    As part of your application, you will be required to submit
draft labeling consistent with:  applicable product-specific
data; the precautionary statements and use directions; and the
regulations concerning classification  [40 CFR S162.11(c)], pack-""
aging [40 CFR §162.16], and labeling  [40 CFR §162.10, Appendix
IV-1 and IV-2], as indicated by the following paragraphs of this
chapter of the guidance document.

    If owners of currently registered products fail to submit
revised labeling and packaging information complying with this
Section and/or Section II, EPA may issue a notice of intent to.
cancel the registration under FIFRA $6(b)(l).

    A.  Label Contents

        40 CFR S162.10 (Appendix IV-1) requires that certain spe-
    cific labeling statements must appear at certain locations
    on the label.  This is referred to as format labeling.
    Specific label items listed below are keyed to the table
    entitled: "Labeling Requirements of FIFRA, As Amended".

        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.  See Appendix
    IV-1.   [40 CFR Sl62.10(b)]

        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.
    See Appendix IV-1.   [40 CFR Sl62.10(c)]

        Item 3.  NET CONTENTS - A net content statement is required
    on all labels.  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
    stated in terms of weight, expressed as avoirdupois pounds

                                64

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and ounces, and stated in terms of the largest suitable unit,
i.e., "1 pound 10 ounces" rather than "26 ounces."  In
addition to the required units specified, net contents may be
expressed in metric units.  See Appendix IV-1.   [40 CFR
§162.10(d)]

    Item 4. " EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No."  The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it.  The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.  See Appendix IV-1.
[40 CFR Sl62.10(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 registration number on
the immediate container cannot be clearly read through such
wrapper or container.  See Appendix IV-1.  [40 CFR S162.10(£)]

    Item 6.  INGREDIENT STATEMENT - An ingredient 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 ingredient
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
agricultural formulations, the pounds per gallon of active
ingredient must be indicated on the label.

    Item 7.  FRONT LABEL PRECAUTIONARY STATEMENTS - All labels
are required to have precautionary statements grouped together
on the front panel, preferably within a block outline.  The
table below shows the minimum type size requirements on
various size labels, as set forth in the Regulations.
                            65

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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 - All  labels are
required to have the statement  "Keep Out of Reach of Children"
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 S162.10  (h)(l)(i)]

    Item 7C.  SKULL & CROSSBONES AND WORD "POISON"  - On products
assigned a toxicity Category I  on  the  basis of oral, inhala-
tion, or dermal  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
     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 5162.10 
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    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 taken to avoid
accident, injury or damage.  'See Appendix IV-1.  [40 CFR §162.10
    Item SB.  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 requirement is based on the results
        of the flashpoint determinations and flame extension
        tests required to be submitted for all products.
        These statements are to be located in the side/back
        panel precautionary statements section, preceded by
        the heading "Physical/Chemical Hazards."  Note that
        no signal word is used in conjunction with the flam-
        mability statements.

    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 flash-
            point greater than 350°F (177°C) as determined
            by the method specified in 40 CFR $163.61-8(c) (13)
            (ii) of Subpart D.

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

            i.  The flame extension is zero incnes, using the
                method specified in 40 CFR §163.61-8(c) (13) (ii) ;

           ii.  There is no flash back; and

          iii.  The flashpoint of the non-volatile liquid
                component is greater than 350°F (177°C),
                determined by the method specified in 40 CFR
                §163.61-8(c) (13)(i).


                                67

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    3.  Declaration of non-flammability.  Products which meet
        the criteria for non-flammability specified above may
        bear the notation "non-flammable" or "nonflammable
        (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 submitted in accordance with 40 CFR
        S163.61-10(c) 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.  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."
See Appendix IV-1.  [40 CFR 5162.10(1)(2)(ii)]

    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.  Make certain that the statement you usa
pertains specifically to your product.  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 for the latest specific
storage and disposal product label statements.

    Item 10B.  DIRECTIONS FOR OSE - 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 Information

    Bulletins, leaflets, circulars, brochures, data sheets,
flyers, and 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.

                            68

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V.    INSTRUCTIONS FOR SUBMISSION

    All applications prepared in response to this Notice should
be'addressed as follows:

    Henry M. Jacoby, Product Manager 21
    Registration Division (TS-767)
    Office of Pesticide Programs
    Environmental Protection Agency
    Washington, D.C.  20460
    Phone No. (703) 557-1900

For each product for which continued registration is desired:

    1.  Within 90 days from receipt of this document, you must
        submit the "FIFRA Section 3(c)(2)(B) Summary Sheet" EPA
        Form 8580-1.  Refer to Appendix II-2 with appropriate
        attachments.

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

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

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

        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 short-term data, the registrant may
            submit such labeling.  (End-use product labeling
            needs to comply specifically with the instruction in
            Section II 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
            stortage 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.

    3.  Within the time set forth in Table A, all generic data
        must be submitted by the affected registrant(s).

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 listed above.

    After the Supreme Court has ruled on the Monsanto Decision,
you will be informed as to when you must submit your Application
for Amended Pesticide Registration (EPA Form 8570-1) and the
associated data support information.

                                  : 69

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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.

    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


                                70

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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,
         immediately following the word "under," is the
         registration number, experimental use permit
         number, petition number, or other administrative
         number associated with the earliest known submission.

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

    (4)  Volume Identification (Accession Numbers).  The
         final element in the trailing parentheses
         identifies the EPA accession number of the volume
         in which the original submission of the study
         appears.  The six-digit accession number follows
         the symbol "CDL," standing for "Company Data
         Library."  This accession number is in turn
         followed by an alphabetic suffix which shows the
         relative position of the study within the volume.
         For example, within accession number 123456, the
         first study would be 123456-A; the second, 123456-
         B; the 26th, 123456-Z; and the 27th, 123456-AA.
                                 71

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                                                            Appendix II-l
                         OFFICE OF PESTICIDE PROGRAMS
                      REGISTRATION STANDARD BIBLIOGRAPHY
         Citations Considered to be Part of the Data Base Supporting
                   Registration Under the Captafol Standard
MRID No.
00025129   Cheng, H.M.  1976.  Metabolism of carbonyl-14C-difolatan in young
           tomato and corn plants.  Chevron Chemical Co. File No. 721.14.
           Dated December 2 and submitted by Chevron Chemical Co. under
           PP#7F1962(099190).

00025130   Cheng, H.M.  1976.  Absorption, translocation, and metabolism of
            [carbonyl-l^JTHPI in young tomato plants.  Chevron Chemical Co.
           File No. 721.14.  Dated August 16 and submitted by Chevron Chemical
           Co. under PPI7F1962(099190).

00096919   Pack, D.E.  1973.  14C-difolatan uptake from soil by carrots - EPA
           protocol.  Chevron Chemical Co. File No. 773.21/Difolatan.  Dated
           October 12.  Submitted by Chevron Chemical Co. as Reference No. 4
           in "Difolatan fungicide - Supplementary Environmental Data"
            (120308).

00096916   Pack, D.E.  1973.  The soil metabolism of carbonyl-14C-difolatan.
           Chevron Chemical Co. File No. 773.21.  Dated November 287.
           Submitted By Chevron Chemical Co., as Reference No. 1 in "Difolatan
           fungicide - Supplementary Environmental Data" (120308).

00072884   Pack, D.E.  1980.  Analysis of soybeans grown from seeds treated
           with 14C-captafol - greenhouse study.  Chevron Chemical Co. File
           No. 721.14.  Dated July 21.  Submitted by Chevron Chemical Co. to
           RGB.

0081808    Potter, J.L.  1965.  Preliminary studies on the j.n vitro degradation
           of difolatan  by crop macerates and filtrates.  Dated May 5,
           prepared by the California Chemical Co., and submitted by
           Chevron Chemical Co. under PP#5G0453(114475) and PP#6F0492(1114612).

05003661   Solel, Z. and L.V. Edgington,.  1973.  Transcuticular movement of
           fungicides.  Phytopathology, Vol. 63, April, pp. 505-510.  (Not
           registrant submitted.)

00096829   California Chemical Co.  1965.  Technical Report Nos. 5K7926 and
           5K7945.  Submitted under PP#5G0453(114475).     ^

00096830   California Chemical Co.  1965.  Technical Report Nos. 5K7926 and
           5K7945.  Submitted under PP#5G0453(114475).
                                      72

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                                                            Appendix II-l
                         OFFICE OF PESTICIDE PROGRAMS
                      REGISTRATION STANDARD BIBLIOGRAPHY
         Citations Considered to be Part of the Data Base Supporting
                   Registration Under the Captafol Standard
MRID No.
00025952   Cheng, H.M. of Chevron Chemical Co. 1977.  Metabolism of difolatan
           in chickens.  Report dated November 3, 1975.  Submitted under
           PP#7F1962(096160).

00025119   Cheng, H.M. of Chevron Chemical Co. 1977.  Metabolism of 14C-
           carbonyl captofol in rats-characterization and quantification of
           *4C in tissues.  Report dated February 26, 1979.  Submitted under
           PP#7F1962(099190).

00025120   Cheng, H. M. of Chevron Chemical Co. Metabolism of [carbonyl-14C]
           THPI and [carbonyl-l4C]THPI-epoxide by rats.  Report dated June 15,
           1979.  Submitted under PP#7F1962(099190).

00025124   Cheng, H. M. of Chevron Chemical Co.  Metabolism of carbonyl 14C
           captafol in a lactating goat.  Report dated July 9, 1979.  Submitted
           under PP#7F1962(099190).

00025127   Crossley, J. of Chevron Chemical Co.  The stability of difolatan
           in human blood.  Report dated October 4,  1967.  Submitted under
           PP#7F19692(099190).

00061996   Crossley, J. of Chevron Chemical Co.  Difolatan:  fate in animals.
           Report dated October 29, 1968.  Submitted under PP#9F0797(115899).

00053240   Crossley, J. of Chevron Chemical Co.  The fate of difolatan in a
           lactating ruminant (goat).  Report dated June 10, 1970.  Submitted
           under PP#9F0797(115899).

00096902   Lee, H. of Chevron Chemical Co.  Metabolism of difolatan in rats:
           identification of urinary metabolites.  Report dated February 28,
           1972.  Submitted under PP#7F1962(096160).

00096847   California Chemical Co. 1964.  Difolatan residue analysis-thin
           layer chromatographic method (Method RM-6).  Submitted under
           PP#5G0453(114470).

00096848   California Chemical Co. 1964.  Difolatan metabolism - the analysis
           of residues of dichloroacetic acid using microcoulometric gas
           chrcmatogrpahy (method RM-6C)  Submitted under PP#5G0453(114470).
                                       73

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                                                            Appendix II-l
                         OFFICE OF PESTICIDE PROGRAMS
                      REGISTRATION STANDARD BIBLIOGRAPHY
         Citations Considered to be Part of the Data Base Supporting
                   Registration Under the Captafol Standard
MRID No.
00096843
00091215
00091214



00052318



0031709


00025123



00096911


00025123
00025133
00091274
00096889
California Chemical Co. 1965.  The analysis of residues of difolatan
and three tetrahydrophthalic acid derivatives (Method RM-6-D). Sub-
mitted under PP#5G0453(114473).

Chevron Chemical Co. 1965.  Difolatan residue analysis by electron
capture gas chronatography (Method RM-6B).  Submitted under
PP#6F0492(114607).

Chevron Chemical Co. 1965.  Difolatan residue methods - a comparison
of RM-6 and RM-6B for several crops.  By P. Berteau.  Submitted
under PP#6F0492(114607).

Chevron Chemical Co. 1966.  Difolatan residue analysis - thin layer
chromatographic method (Method RM-6, revised).  Submitted under
PP#6F0492(114607).

Chevron Chemical Co. 1973.  Addendum to RM-6B for determination of
residues of difolatan in sweet corn, tomatoes, and peanuts.  Submitted
under PP#3F1412(118300).

Chevron Chemical Co. 1975.  Determination of captafol residues by
gas chromatography method RM-6E-1.  Submitted under PP#6E1775.

Chevron Chemical Co. 1976.  Determination of residues of captan
and its metabolites in animal tissues (Method RM-1G-1).  Submitted
under PP#7F1962(096160).

Chevron Chemical Co. 1978.  Determination of captafol residues by
gas chronatography method RM-6E-2.  Submitted under PP#7F1962(099190).

Chevron Chemical Co. 1979.  Determination of captafol, captan,
THPI, and 3-OH THPI in tissues and eggs and determination of captan
THPI, 3-OH THPI, and 5-OH THPI in milk and cream.  Submitted under
PP#7F1962(099190).

Chevron Chemical Co.  1979.  Determination of residues of THPI in
crops - Residue Method RM 6J-1 and RM 1J-1.  By E.J. Elliott, J.C.
Lai and F.J. Schwab.  Submitted under PP#8F2047(070837).

Chevron Chemical  Co.  1966.  Storage stability of difolatan
residue samples.  File:  741.10/Difolatan.  Test Nos. 712-716,
776, 831, and 871.  Submitted under PP#6F0492(114611).

IR-4.  Rutgers University.  1976.  Test Nos. 3210, 3209, 3241,
3011, and 3202-3205 in Section D of PP#6E1175 (undesignated
accession number).
                          74

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                                                            Appendix  II-l
                         OFFICE OF PESTICIDE PROGRAMS
                      REGISTRATION STANDARD BIBLIOGRAPHY
         Citations Considered to be Part of the Data Base Supporting
                   Registration Under the Captafol Standard
MRID No.

00096828


00096817


00096858

00097842
00069607
00062907
00030479
00096964
Chevron Chemical Co.  1966.  Residue data sheets for experiment
T-714.  Section D.  PP#6F0492(114607).

Chevron chemical Co.  1967.  Test Nos. 710, 716, 717, 869, and
870.  Residue data sheets in Section D of PP#6F0492(114607).

Chevron Chemical Company.  1966.  Section A of PP#6F0492(114510).

Sanders, H.O. (1969) Toxicity of Pesticide to the Crustacean
Gammarus iacustris.  By U.S. Fish and Wildlife Service, Fish-Pesticide
Research Laboratory.  Washington, D.C.:  USFWS, (Technical papers
of the Bureau of Sport Fisheries and Wildlife 25;  Stauffer T-2214;
published study; CDL:246020-K)

Thompson, C.M.;  Griffen, J.; Boudreau, P.; et al. (1980) Acute
Toxicity of Difolatan Technical (Sx-945) to Bluegill Sunfish
("Lepomis macrochirus11): ABC Report #26575/#26576.  (Unpublished
study received Feb 2, 1981 under 239-2369; prepared by Analytical
Bio Chemistry Laboratories, Inc., submitted by Chevron Chemical
Co., Richmond, Calif., CDL:244371-8)

Forbis, A.D.; Boudreau, P.; Cranor, W.; et al. (1980) Static Acute
Toxicity of Difolatan Technical (SX-945) to "Daphnia magna" (S-
1798): ABC Report # 25857.  (Unpublished study received Nov 19,
1980 under 239-2211; prepared by Analytical Bio Chemistry
Laboratories, Inc., submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:243833-A)

Beavers, J.B.; Fink, R. (1979) Final Report:  One-Generation
Reproduction Study—Mallard Duck:  Project No. 162-109.  (Unpublished
study including addendum and letters dated Dec. 1, 1978; Mar 1,
1979; Apr 2, 1979 and Nov 14, 1978 from J.B. Beavers to Francis X,
Kamienski, received Feb 21, 1980 under 239-2211;  prepared by
Wildlife International, Ltd., submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:099267-A)

Fink, R.; Beavers, J.B.; Grimes, J.: et al.  (178) Final Report:
Acute Oral 11)59—Bobwhite Quail: Difolatan Technical: Project No.
162-101.  (Unpublsihed study received Dec 13, 1978 under 239-2211;
prepared by Wildlife Internatioanl Ltd, and Washington College,
submitted by Chevron Chemical Col, Richmond, Calif.;  CDL:236618-A)
                                        75

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                                                            Appendix II-l
                         OFFICE OF PESTICIDE PROGRAMS
                      REGISTRATION STANDARD BIBLIOGRAPHY
         Citations Considered to be Part of the Data Base Supporting
                   Registration Under the Captafol Standard
MRID No.
00096965   Fink, R.; Beavers, J.B.; Grimes, J.; et al.  (1979) Final Report:
           Eight-day Dietary ICso—Bobwhite Quail: Difolatan Technical  (SX-
           945): Project No. 162-114.   (Unpublished study received Mar  13,
           1979 under 239-2211; prepared by Wildlife International Ltd. and
           Washington College, submitted by Chevron Chemical Co., Richmond,
           Calif.; CDL:237803-8)

00041447   Beavers, J.B.; Fink, R.; Grimes, J.; et al.  (1979) Final Report;
           One-Generation Reproduction  Study—Bobwhite Quail: Project No. 162-
           108.   (Unpublished study including addendum and letters dated
           Dec. 11, 1978; Mar 1, 1979;  Apr 2, 1979; Apr 25, 1979 and Nov 14,
           1978 from J.B. Beavers  to Francis X, Kamienski, received Feb 21, 1980
           under 239-2211; submitted by Chevron Chemical Co., Richmond,
           Calif., CDL:099267-B)

00003503   Johnson, W. and M. Finley 1980.  Handbook of Acute Toxicity  of
           Chemicals to Fish and Aquatic Invertebrates.  USDI Publication
           137, Washington, D.C.

00014690  Cavalli, R.D.  (1970) Skin Sensitization Potential
          of RE 12,420 (75% SS):SOCO 156/111:85.  (Unpublish-
          ed study received Jun 21, 1972 under 239-EX-61;
          submitted by Chevron Chemical Co., Richmond, Calif.
          CDL:223505-U).

00046435  Shirasu, Y., M. Moriya,  K. Kato, A. Furuhashi,
          and T. Kada; (1976) Mutagenicity Screening of
          Pesticides in the Microbial System. Mut.
          Research 40, 19-30.

00061996  Crossley, J. (1968) Difolatan: Fate in Animals:
          File No. 721.14. (Unpublished study received Apr
          15, 1969 under 9F0797; submitted by Chevron Chem-
          ical Co., Richmond, Calif.; CDL:091370-E)

00087538  Cerkanowicz, D.A. (1981)  The Skin Irritation Pot-
          ential of Difolatan 80 WDG: Socal 1837 (S-1977).  *
          (Unpublished study received Dec 1, 1981 under
          239-2495; submitted by Chevron Chemical Co., Rich-
          mond, Calif.; CDL:246325-E)

00027544  Bradfield, L. G. (1980)  Dominant Lethal Study of Difolatan
          Technical:  Socal 1354.  (Unpublished study received Feb.
          11, 1980 under EPA Registration File 239-2211;  submitted
          by Chevron Chemical Co., Richmond, Calif.;  CDL:099266-A).
                                     76

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                                                           Appendix II-l
                           OFFICE OF PESTICIDE PROGRAMS
                        REGISTRATION STANDARD BIBLIOGRAPHY
           Citations Considered to be Part of the Data Base Supporting
                     Registration Under the Captafol Standard
  MRID No.
00088817    Chevron Chemical Company (1981)  Difolatan Tech-
            nical (SX-947) Lifetime Mouse Oncogenicity Feed-
            ing Study: Socal 1330 (S-1391). (Unpublished
            study received Jul 30, 1981 under 239-2211; CDL:
            246380-A)

00093672    Reno, F.E., J.L. Barlow, G.A. Burdock, et. al.
            (1981) Subchronic Toxicity Study in Rats: Difolatan
            Project No 2107-102.  Final Rept.  (Unpublished
            study received Dec 15, 1981 under 239-2230?
            prepared by Hazleton Laboratories America, Inc.,
            submitted by Chevron Chemical Co., Richmond, Calif.;
            CDL:246577-A)

00096902    Lee, H. (1972)  Metabolism of Difolatan in Rats:
            Identification of Urinary Metabolites: File No.
            721.14.  (Unpublished study received Jun 9, 1977
            under 239-2211; submitted by Chevron Chemical Co.,
            Richmond, Calif.; CDL:096157-D)

05001994    Robens, J.F. (1970)  Teratogenic Activity of Sev-
            eral Phthalimide Derivitives in the Golden Hamster.
            Toxicology and Applied Pharm. 16, 24-34.
                                         77

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                                                            Appendix II-l
                         OFFICE OF PESTICIDE PROGRAMS
                      REGISTRATION STANDARD BIBLIOGRAPHY
         Citations Considered to be Part of the Data Base Supporting
                   Registration Under the Captafol Standard
GS No.
GS0122001  Buttler, B. and W. D. Hermann.  1981.  High-pressure liquid
           chromatographic determination of captan, captafol, and folpet
           residues in plant material.  J. Agric. Food Chem. Vol. 29(2);257-
           260.

GS0122002  Chevron Chemical Co. 1973.  Revision of difolatan residue analysis
           by electron capture gas chromatography method RM-6B.  Submitted
           under PP#4E1480(093931).

GS0122003  Chevron Chemical Co. 1980.  Determination of captafol and THPI
           residues in crops (Method RM-6K-1).  Submitted under PP#8F2047
           (070837).

GS0122004  Chevron Chemical Co.  1980.  Determination  of captafol and THPI
           residues in crops (Method RM-6K-2).  Submitted under PP#8F2047(070837)

GS0122005  Chevron Chemical Co.  1981.  Determination of captafol and THPI
           residues in coffee beans.   (Method RM-6L).  Submitted under
           PP#8F2047(070837).

GS0122006  Ngoran, N., C.D. Ercegovich, K.D. Hickey and R.O. Mumma.  1979.
           An improved analytical procedure for captafol residues in apple
           wood, leaves, and fruit.  J. Agric. Food Chem. Vol. 27 (6):1167-
           1170.

GS0122007  Chevron Chemical Co.  1970.  Test Nos. 1171, 1250, 1251, 1356,
           1357 (Sample Nos. 1, 2, 4,  and 5), 1430, 1501, 1543, 1715, and
           1802 in Section D of PP#OF0895(116328).

GS0122008  Chevron Chemical Co.  1966.  Residue data sheets for experiments T-
           708, T-718, T-785, T-862.   Section D.  PP#6F0492(114607).

GS0122009  Chevron Chemical Co.  1966.  Residue data sheets for experiments
           T-1176, 1175.  Section D.   PP#6F0492(114605).

GS0122010  Chevron Chemical Co.  1966.  Residue data sheets for experiments
           T-1181, T-1182.  Section D.  PP#6F0492(14611).

GS0122011  Chevron Chemical Co.  1968.  Residue data sheets for experiments
           "T"-2647-2650, 3229-3231, 3245-3248, 2660-2663, 3249, 3250, 3252,
           3253, 3424, 3580-3582, 3825, 3826, 4031, 4032, 4991, 5027, 5028.
           Section D.  PP#8E2062 (096918 and 099965).

                                     78

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                                                            Appendix II-l
                         OFFICE OF PESTICIDE PROGRAMS
                      REGISTRATION STANDARD BIBLIOGRAPHY
         Citations Considered to be Part of the Data Base Supporting
                   Registration Under the Captafol Standard
GS No.
GS0122012  Chevron Chemical  Co.  1971.  Residue data sheets for tests
           T-1608, T-1641, T-1642, T-1643, T-1644, T-1769, T-1770, T-1771, T-
           1773, T-1774.  Submitted in Section D.  PP#1F1020(116849).

GS0122013  Chevron Chemical Co. 1973.  Test nos. 977, and 2420-2424 in Section
           D of PPf3F1412(118300).

GS0122014  Chevron Chemical  Co.  1971.  Test nos. 963, 964, 965, 1808, and
           1809 in Section D of PP#1F1020(116849).

GS0122015  Chevron Chemical Co.  1970.  Residue data sheets for experiments
           T-1636, T-1637, T-1638, T-1872, T-1752, T-1870, T-1871.  Section
           D.  PPfOF0895(116328).

GS0122016  Chevron Chemical Co.  1981.  Test No. T-5401 in a captafol amendment
           entitled Difolatan 80 Water Dispersible Granules EPA Reg. No. 239-
           NEW, 12-03.  Residue  Chemistry Data submitted by Chevron Chemical
           Co. on November 18, 1981 to RGB (under 239-2495; in Accession No.
           246324).

GS0122017  Chevron Chemical Co.  1976.  Test nos. 2636, 2637, 2638, 2793,
           2860, 2861, 3038, 3185, 3186, 3187, 3359, and 3360 in Section D of
           PPI6F1676 (no accession number available).

GS0122018  Chevron Chemical Co.  1974.  Test Nos. 2628, 2629, 2630, and 2631
           in Section D of PP#4G1420(118327).

GS0122019  Chevron Chemical Co.  1971.  Test Nos. 966-968 and 1003 in Section
           D.  Submitted under PP#1F1020 (116849).

GS0122020  Chevron Chemical Co.  1970.  Test Nos. 1518, 982, 1448, and 1429
           in Section D of PP#OF0895(116328).

GS0122021  Chevron Chemical Co.  1966.  Residue data sheets for experiment
           T-1183, T-1184, T-1190.  Section D.  PP#6F0492(114611).

GS0122022  Chevron Chemical Co.  1970.  Test Nos. 778-780, 826, 1138-1141,
           1342-1349, and 1716-1718 in Section D of PP#OF0895(116328).

GS0122023  Chevron Chemical Co.  1983.  12.03.  Residue chemistry data to
           support an amendment to the difoloatan 4 flowable (EPA Reg. No.
           239-2211-AA) label for potatoes to add sprinkler irrigation
           applications.  Submitted February 16, 1983 (249527).
                                       79

-------
                                                            Appendix II-l
                         OFFICE OF PESTICIDE PROGRAMS
                      REGISTRATION STANDARD BIBLIOGRAPHY
         Citations Considered to be Part of the Data Base Supporting
                   Registration Under the Captafol Standard
GS No.
GS0122024  IR-4.  Rutgers University.  1974.  Section D of PP#4E1480(093931).

GS0122025  Chevron Chemical Co.  1966.  Test Nos. 711, 890, and 891 in Section
           D of PP#6F0492(1146505).

GS0122026  Chevron Chemical Co.  1966.  Test Nos. 1177^and 1178.  Submitted
           under PP#6F0492(114605).

GS0122027  Chevron Chemical Co.  1981.  Test Nos. 5400 and 5404.  12-03.
           Residue chemistry data to support a new label registration for
           difolatan 80 water dispersible granules.  EPA Reg. No. 239-NEW.
           Submitted November 18, 1981 (246324).

GS0122028  Chevron  Chemical Company, Ortho Division.  1965.  Ortho method of
           analysis D-VIII, Difolatan by Gas Chromotography data 2/8/65,
           PP#6F0492(114612).

GS0122029  Chevron Chemical Company.  1966.  Data sheets for EPA Reg. No. 239-
           2230 in PP#6F0492(114612).

GS0122030  Chevron Chemical Company, Ortho Divison.  1967.  Data from
           correspondence sent to EPA on EPA Reg. No. 239-2230 data 5/25/67,
           and located in the registration jacket.

GS0122031  EPA.  1975.  Captafol. EPA-1 (tentative), In Manual of Chemical
           Methods for Pesticides and Devices.  EPA, OTS.

GS0122032  Sittig, Marshall (ed.).  1977.  Pesticides Process Encyclopedia.
           Corp. Park Ridge, NJ. p.82.

GS0122033  U.S. EPA.  1980.  Report on Toxicity of Difolatan Technical to
           Rainbow Trout.  (U.S. EPA, Chemical and Biological Investigations
           Branch, Beltsville, MD.  Flow Through, Test No. 2466, unpublished
           report.)

GS0122034  U.S. EPA.  1976.  Report on Toxicity of Captafol technical 97% to
           Rainbow Trout.  (U.S. EPA Chemical and Biological Investigations
           Branch, Beltsville, MD.  Static Jar, Test No. 7A4/76, unpublished
           report.)

                                     80

-------
                                                            Appendix II-l
                         OFFICE OF PESTICIDE PROGRAMS
                      REGISTRATION STANDARD BIBLIOGRAPHY
         Citations Considered to be Part of the Data Base Supporting
                   Registration Under the Captafol Standard
GS No.
GS0122035
GS0122036
GS0122037
GS0122038
GS0122039
GS0122040
GS0122041
GS0122042
U.S. EPA.   1980.  Report on the Toxicity of Difolatan Technical to
Daphnia magna.  (U.S. EPA, Chemical and Biological Investigations
Branch, Beltsville MD, Static Jar, Test No.  2458, 10/24/80,
unpublished report.)

U.S. EPA  1980.  Report on Toxicity of Difolatan Technical to
Bluegill Sunfish in a Static Test.  (U.S. EPA, Chemical and Biological
Investigations Branch, Beltsville, MD.  Static Jar, Test No. 2465,
11/19/80, unpublished report.)

U.S. EPA.  1976.  Report on Toxicity of Captafol Technical 97% on
Bluegill Sunfish. (U.S. EPA, Chemical and Bological Investigations
Branch, Beltsville, MD.   Static Jar. Test No. 994, 7/14/76,
unpublished report.)

U.S. EPA.  1980.  Report on the Toxicity of Technical Difolotan to
Bluegill Sunfish in a Flow-through Test.  (U.S. EPA, Chemical and
Biological Investigations Branch, Beltsville, MD.  Flow Through,
Test No. 2465, 11/19/80, unpublished report.)

Beavers, J.B., and R. Fink.  1979  Final Report:  Eight-day
Dietary LCsQ-Mallard Duck: Difolatan Techincal (SX-945): Project
No. 162.  (Unpublished study received under 239-2211;  prepared by
Wildlife International ltd. and Washington College, Submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:237803-B.)

Moriya, M., K. Kato, and Y. Shirasu. (1978) Effects
of Cysteine and a Liver Metabolic Activation System
on the Activities of Mutagenic Pesticides., Mut. Res.
57, 259-263

Tezuka, H., N. Ando, R. Suzuki, M. Terahata, M.
Moriya, and Y. Shirasu. (1980)  Sister-Chromatid
Exchanges and Chromosomal Aberrations in Cultured
Chinese Hamster Cells Treated with Pesticides Pos-
itive in Microbial Reversion Assays.  Mut. Res.
78, 177-191.

Bio/Dynamics, Inc. (1983) Teratology Study in
Rats of Difolatan Technical. Project #83-2716.
Oct. 14, 1983. (Unpublished study received under
239-2230; submitted by Chevron Chemical Co, Richmond,
Calif.; EPA Ace. No. 251812.)
                                       81

-------
                                                              Appendix II-l
  GS No.

GS0122043
GS0122044
GS0122045
GS0122046
GS0122047
GS0122048
                           OFFICE OF PESTICIDE PROGRAMS
                        REGISTRATION STANDARD BIBLIOGRAPHY
           Citations Considered to be Part of the Data Base Supporting
                     Registration Under the Captafol Standard
Bio/Dynamics, Inc. (1983) Two-Generation Reproduc-
tion Study in SpragueHDawley Rats. Project #80-2530.
Oct. 10, 1983. (Unpublished study received under
239-2230; submitted by Chevron Chemical Co, Richmond,
Calif.; EPA Ace. No. 251972-251977.)

Hazleton Laboratories. (1983) 2 Year Chronic Toxicity
Study in Rats of Difolatan Technical (SX-945).
#2107-103. June 15, 1983.  (Unpublished study received
under 239-2230; submitted by Chevron Chemical Co.,
Richmond, Calif.; EPA Ace. No. 250921-250924.)

Bioresearch Laboratories Ltd. (1983) Teratology
Study in the Rabbit with Captafol Technical.
#81154. Dec. 6, 1983. (Unpublished study received
under 239-2230; submitted by Chevron Chemical Co.,
Richmond, Calif.; EPA Ace. No. 253055-253056.)

Chevron Chemical Co.  (1984) Toxicology Data. March
1, 1984. S-2153, 2154, 1967, and 1858. (Unpublished
studies received March 2, 1984 under 239-2230;
submitted by Chevron Chemical Co., Richmond, Calif.;
EPA Ace. No. 252599.

EG&G/Mason Research Institute. (1983) In Vivo
Cytogenetics Study in Rats with Chevron Difolatan
Technical (SX-945). Oct. 7, 1983. MRI-224-CCC-83-31
(Unpublished study received under 239-2230; submitted
by Chevron Chemical Co., Richmond, Calif.; EPA Ace.
No. 252331-252332.

Bio/Dynamics Inc. (1984)  Teratology Study in Rabbits
with Captafol Technical.  Feb. 22, 1984.  Proj. NQ.
83-2734. (Unpublished study received under 239-2230;
submitted by Chevron Chemical Co., Richmond, Calif.;
EPA Ace. No. 248965.
                                         82

-------
  GS No
GS0122049
GS0122050
GS0122051
GS0122052



GS0122053



GS0122054



GS0122055


GS0122056



GS0122057
                                                           Appendix II-l
                           OFFICE OF PESTICIDE PROGRAMS
                        REGISTRATION STANDARD BIBLIOGRAPHY
           Citations Considered to be Part of the Data Base Supporting
                     Registration Under the Captafol Standard
 Chevron Chemical Co. (1981) Primary Eye Irritation
 in Rabbits. Sept. 11, 1981. Socal 1838. (Unpublish-
 ed study received under 239-EUOL;  submitted by
 Chevron Chemical Co., Richmond, Calif.; EPA Ace. No.
 246326.

Chevron Chemical Co.  1981.  12.03.  Residue chemistry data to
support a new label registration for difolatan 80 water dispersible
granules.  Submitted November 18, 1981 (246324).

California Chemical Company, Ortho Division, 1963.  Report
entitled "Difolatan- A Preliminary Report on It's Hydrolysis
and Related Reactions" dated 7/30/63.  File No. 740.10.  By
P. E. Berteau.  Located in PP No. 6F0492 (114610).

Chevron Chemical Co.  1965.  Difolatan residue methods - a
comparison of RM-6 and RM-6B for several crops.  By P. Berteau.
Submitted under PP No. 6F0492 (114607).

Chevron Chemical Co. 1973.  Revision of difolatan residue
analysis by electron capture gas chromatography method
RM-6B.  Submitted under PP No. 4E1480 (093931).

Davis, J. 1978.  An analysis of Exposure Data Obtained During
the Airblast Spraying of Orchards with Selected Pesticides.
Unpublished EPA Laboratory Report.

Reinert, J. C., and D. J. Severn.  (?)  Dermal Exposure
to Pesticides:  EPA's Viewpoint.  ACS Symposium Series (in print).

Jensen, J. K. 1982.  Applicator Exposure Analysis,  Captan Position
Document 2/3.  Final Report, Environmental Fate Branch, Hazard
Evaluation Division, US EPA.

Versar, Incorporated  1984.  Applicator and Mixer/Loader Exposure to
Pesticides During Ground Boon Spraying Operation, Final Report.
EPA Contract No. 68-01-6271, Task No. 48.
GS-122058  US EPA  1980.  Position Document 2/3 on Wood Preseratives.
                                       83

-------
                                                Appendix II-!
                OFFICE OF PESTICIDE PROGRAMS
             REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
          Registration Under the Captafol Standard
  GS No

GS0122059
GS0122060
     Felthausen, R. W. 1977.  Data Review of Interim Report for
     Experimental Use Permit for Aerial Application on Cranberries
     (239-EUP-62).  Data review dated January 31, 1977:
     Environmental Safety, Efficacy and Ecological Effects
     Branch, US EPA.

     Felthausen, R. W. 1977.  Data Review of Interim Report for
     Experimental Use Permit for Aerial Application on Cranberries
     (239-EUP-62).  Data review dated May 7, 1977:  Environmental Safety,
     Effficacy and Ecological Effects, US EPA.

-------
                               Appendix  .TI-2
                                                                             OMB Approval No. 20004468
              FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
                                                                                     EPA REGISTRATION NO.
IODUCT NAME
iptlCANTS NAME
                                 DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, 1 am responding in the following manner
  D1.  I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
        specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
        Chemicals Tatting Programme, I enclose the protocols that I will use:
  D 2.  I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
        requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
  G 3.  I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
        respect to the following data requirements!
  D 4.  I request that you amend my registration by deleting the following uses (this option is not available to applicants for new product]):
  D 5.  I request voluntary cancellation of the registration of this product (This option is not available to applicants for new products.)
EGISTRANTS AUTHORIZED REPRESENTATIVE
     \
SIGNATURE
                                                    DATE
A Form 8S80-1 (10-82)
                                                               85

-------
Appendix "II-3
                           OMB Aooroval No 2OOOJM6B
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To qualify, certify ALL four items) FOR DEVELOPMENT OF DATA
1. 1 am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM
.



GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMPANY NUMBER




(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
into an agreement with one or more other registrants to develop jointly, or to share in th
items or data:
i. However, my firm would prefer to ente
e cost of developing, the following require
1 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 b
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was mad
to the following firmfe) 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) abof
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. 1 understand EPA will promptly infon
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statemei
does not apply to applicants for new products.) 1 give EPA permission to disclose this statement upon request.
TYPED NAME SIGNATURE DATE
EPA Form 88804 (10-32) 86

-------
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                   87

-------
                             Appendix IV-1
Chapter I—Environmental Protection Agency
                                                                  §11
     obtained the data, from anothe
     (identify): applicant copied  da/
     a publication: applicant obt
a coby of the data from EPA).
  (dAThe applicant shall submit
his application a statement that
in its {valuation of the properties/effi-
cacy. Vnd  safety  of  the formulated
end-use product, may not consider any
         supporting the application.
          following data:
          data the applicant lias sub-
           ?A under paragraph (b) of
                                        (1
data
except
  (1)
mitted to
this sect!
  (2)  Oth
safety of
ents, rathi
end-use
  (3) Exist
regulations.
             data pertaining to  the
           te product's actwe ingredi-
            than to the safety of the
             ct; and
             tolerances, food additive
             xemptions/ and  other
clearances  issued  undezf the Federal
Food. Drug, ana Cosmera Act.
  (e) If the applicant mows that any
item of data he\submjfcted under this
section was generated Joy (or at the ex-
pense of) anothenpenon who original-
ly submitted the ttafa to EPA  (or its
predecessor. USDAyon or after Janu-
ary 1. 1970, to support an application
                         lental • use
                      adding  a new
                          an. or  for
                      the  applicant
                ' dataVsubmitter have
                       lent  on the
                termsXpf payment of
              Ion that\may be pay-
                             section
              1th  regard to approval
             ;ion). the applicant shall
            ?A  a  statement that  he
              to each suck identified
           , submitter
           Ication of the  Applicant's
                             includ-
for  registration.
permit,  or amenc
use to an existing
reregistration
and the orig
reached  writ
amount and tt
any come
able    unc
3(c) telephone number.
                                                            of- data

                                                              ies or ei
                                                            ijent: and
                                                             Vof data
      If the  applicant's  produce
tairit any active ingredient other
those, that are present solely b
of theV incorporation into the p:
duringVformulation. of  one
other registered  pesticide  «r
-------
                          Appendix IV-1  (continued)
§ 162.10

  (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:
  (vi) An ingredient statement as pre-
scribed in paragraph  (g)  of  this
section:
  (vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section:
  (viii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
  (ix) The  use classification(s) as pre-
scribed in paragraph (j) of this section.
  (2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations  in  this pan must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness   (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-point or larger .type:
  (B)  Appear  on a clear  contrasting
background: and
  < C) Not be obscured or crowded.
  (3? La.nyva.ge to be •used. All required
label  or labeling text shall appear-in
the English  language. However,  the
Asency 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 mis-
branding 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
   Title 40—Protection of Environment

 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 pan of the package as
 customarily distributed or sold.
   (ii) Tank cars and other bulk con-
 tainers—(A) Transportation. While 2
 pesticide product is in transit, the  ap-
 propriate provisions of 49 CFR Parts
 170-189. concerning the transportation
 of hazardous materials, and specifical-
 ly those provisions concerning the la-
 beling, marking and placarding of haz-
 ardous materials and the vehicles car-
 rying them, define the basic Federal
 requirements. In addition, when any
 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.
   (5) False  or misleading statements.
 Pursuant to section  2(q)(l)
-------
                                 Appendix IV-1 (continued)
Chapter I—Environmental Protection Agency
                            §U
any  agency of  the Federal Govern-
mentt
  (vi) The name of a pesticide which
contains two or 'more principal active
ingredients if the name suggests one
or more but  not all  such principal
active  ingredients  even though the
names of the other ingredients are
stated elsewhere in the labeling:
  (vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
  (vul) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
  (ix) Claims  as to the safety of the
pesticide or its  ingredients, including
statements such as "safe." "nonpoison-
ous," "noninjurious,"  "harmless"  or
"nontoxic to humans and  pets" with
or without such  a qualifying phrase as
"when used as* directed"; and
  (x) Non-numerical and/or 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, (1) Except
as provided  in paragraph (a)(6Xli)  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:
  (1) Is false or misleading, or
  (21)  Has not been approved by the
Administrator through registration  or
supplemental  registration as an addi-
tional name pursuant to § 152.S(b)(4).
  (c)  Name and address of prodi
registrant, or person  for  whom
duced. An unqualified name  and
dress given on the label shall be
sidered as the name and address of
producer. If the registrant's name
pears on the label and  the registry
not the producer, or if  the name of
person for whom  the pesticide
produced appears on the label, it &
be  qualified  by appropriate  won
such as "Packed for •  * '," "Distril
ed by • • •." or "Sold by • • •" to si
that the name is not that of the p
ducer.
  (d)  Net weight or measure of
tents. (1) The net weight  or meas
of content shall be exclusive of wr
pers or other materials and shall
the average content unless explicit
stated as a minimum quantity.    1
  (2)  If the pesticide  is * liquid, I
net  content  statement shall be
terms of  liquid measure at 68* F (201
and shall be expressed  in conventioi
American units of fluid ounces, pin
quarts, and gallons.
  (3) If the pesticide is  solid or semii
lid. viscous or pressurized, or is a m
ture of liquid and solid, the net eg
tent statement shall be in term
weight   expressed  as  avoirdupt
pounds and ounces.
  (4) In all cases, net content shall
stated in terms of the  largest  suits!
units, i.e.. "1 pound 10  ounces" rati
than "26 ounces."
  (5) In addition to the required uu
specified,  net  content  may  be
pressed in metric units.
  (6)  Variation above
tent or around an average is p<
ble only to the extent that it
sents deviation unavoidable in go
manufacturing   practice.   Variatii
below a stated m<"
-------
                         Appendix  IV-1  (continued)
§162.10

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  establishments reyis-
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.
  (gj Ingredient statement—(I) 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 ingredi-
ents" and the inert ingredients by the
term "inert Ingredients," or the  singu-
lar forms of these  terms when appro-
priate. Both  terms shall be ic  the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which 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.
   TItl« 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) Names 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 25
-------
                       Appendix  IV-1  (continued)
Chapter I—Environmental Protection Agency
inert ingredfent(s) to be listed in the
ingredient statement if he determines
that such  ingredient(s) may pose  a
hazard to man or -the environment.
  (h)   Warnings  and  precautionary
statements.  Required   warnings  and
precautionary statements  concerning
the  general  areas  of lexicological
hazard including hazard  to  children.
environmental hazard, and physical or
chemical hazard fall into two groups:
those required on the front panel of
the labeling and those  which  may
appear  elsewhere.  Specific
ments concerning content, placem
type  size,  and prominence are
below.
  (1)  Required front panel statemt
With  the  exception  of the  c
hazard warning statement, the text
quired on the front panel of the 1
is determined by the Toxicity Cat*
ry of the pesticide. The category lj
signed on the  basis of  the hig;
hazard shown by any of the indicat
in the table below:
Hazard mdKatora
rM'OW
MflaMBon LC— _
"-"•••" "M
Tdflcfly caiagonas
'
Up co and Mdutng 50
mo/kg.
UD to and including 3.
mg/K«r.
Up to and 'mOuang 200
tng/ho,
Canaan*: comaal
ooacty not ra»ar«*la
M0in7daya.

II !
:
Prom 50 mm WO mg/kgj
From .2 mm 3 mg/ttar — !
From 200 mm 2000 — |
Cornaal oeaety !
ravarMla wrtrtn 7 |
days: mtabon j
parmng tor 7 day*. !
now*. ;
« 1
From 500 BWJ 5COO mg/ I
X* I
From 2. cws SS .na/Har-,
From 2.000 mm 20.000—i
NO comaa* ocaoty? j
Mthin 7 days.
Modaraia ontanen at 72 •
news. j
IV
Oraatar man 5000
"*
Sraatar man JOmj
Sraatar man 20.0M
No vntioon.
MiW of stiQftt vn&D
72 nous.
  (1) Human hazard signal word—(A)
Toiicity Category L All pesticide prod-
ucts meeting the criteria of Toxicity
Category  I  shall bear  on the  front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on the basis of its
oral, inhalation or dermal toxicity (as
distinct from skin  and eye  local ef-
fects) the word "Poison" shall appear
in red on a  background of  distinctly
contrasting  color and the skull and
crossbones shall appear in immediate
proximity to the word "poison."
  (B) Toxicity Category II.  All  pesti-
cide products meeting the criteria of
Toxicity Category n shall bear on the
front -panel  the signal word "Warn-
ing."
  (C) Toxicity Category 111.  All  pesti-
cide products meeting the criteria of
Toxicity Category  HI shall  bear on
the front panel the signal word "Cau-
tion."
  (D) Tosicity Category TV.  All  pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
  (E) Use  of signal  words. Use of any
signal word(s) associated with a higher
Toxicity Category is not  permit
except  when the  Agency  deternii
that such labeling is necessary to
vent unreasonable adverse effects
man or tne environment.  In  no c
shall more than one human haz
signal word appear on the front pa
of a labeL
  (ii) Child hazard warning. Every
tlcide product label ahail bear oni
front panel the statement "keep out
reach  of  children."   Only in  a
where  the likelihood  of contact
children during distribution,  mar
ing. storage or use is demonstrated
the applicant, to be extremely  renu
or if the nature of the pesticide is si
that it is approved for use on i
or small children, may the Administ
tor waive this requirement.
  (iii)  Statement of  practical  tn
ment—
-------
                              Appendix IV-1  (continued;
§ 162.10

placement of the statement of practi-
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 (hXlXiiiXA) 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:
                                  Title 40—Protection of Environment
                                Siza of laoai from canal n seuaf •
                                        cncnas
                      „__.    "Ka«o out
                     J3* „  i o* raacn of
                     ££,2?  ;  0**""

*(»-• • "f lfl
Aggy, 10 »J 1J 	
Aftov* IS to JO 	 	
OfOT

si
10 i
12 i
181
S
8
a
10
12
                                 (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) Hazard  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
 qurad.1.
May M  fatal if mMomd fmnalad or aeaeroad
 motion tti* stanj. Oo not braattw vaoon Ceust or
 spray mat]. Oo not gal a *yo. an  sun. or on
 doming. CAopropnata1 first aid statsrnanta raouvad.].
Harmful a maiiowad Cinnatao or aeseroad motion ma
 akin]. Av«J oraamng vapora tduw or »ray mat].
 wMid contao wvot sjun C^wa or doiftn^j.
 pnaM first ftd  statarrMnt raouwo.1.
[No pracauaonaiy naiarnana raourad.]
I Corrnma. mnaa  tva and nun oamaga  Cor-i*u>:
I  irmaaon]. Oo not gat n (yn.  on slun. or on
I  ctotnme. W«ar googMs or laca «Mid and njeoar
j  gtovaa «rwn handling. Harmful or fatal 4 n»«ao»»d.
I  CAppropnata first Jid statarnant raoutfvd.1
| Cnnai «ya (and Stan] rmanon. Oo not oat n cyaa.
  on Hon. or on dotting. Harmful if iwtuomta. CAo-
  propnata first aid statarnant raouvad.J

| Avoid ujinaci  wim vun. cyaa or domng. in caaa of
;  contact immaovtaiy ftusn «y«a or sun witn pianty of
•  mnr. Gat  nwolcai anannon >f mnanon

i CNo pracauoenary natanMnn raeuwva]
  (U) Environmental hazards. Where a
hazard exists to non target organisms
excluding  humans  and domestic ani-
mals, precautionary statements are re-
quired  stating  the  nature of  the
                               hazard  and  the  appropriate, precau-
                               tions  to  avoid  potential  accident.
                               injury or  damage.  Examples of  the
                               hazard  statements  and  the  circtun-
                    93

-------
                       Appendix  J.V-JL
Chapter I—Environmental Protection Agency
stances under which they are required
follow:
  (A) If a pesticide intended for out-
door use contains an active ingredient
with a  mammalian acute oral LD» of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
  (B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LC» of 1 ppm or less,
the statement "This Pesticide is Toxic
to Fish" is required.
  (O If a pesticide intended for out*
door use contains an active ingredient
with an avian acute oral LD»  of  100
mg/kg  or  less, or a  subacute dietary.
LCta of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
  (D) If either accident history or field
studies demonstrate  that  use of  the
                                      I
      pesticide  may  result  in  fatalit
      birds, fish or mammals, the state
      "This  pesticide is extremely to
      wildlife (fish)" is required.
        (E) For uses  involving foliar ap
      tion to agricultural  crops, fores
      shade  trees, or for mosquito
      ment treatments,  pesticides toxi
      pollinating insects must bear appi
      ate label cautions.
        (F) For all outdoor uses other
      aquatic  applications  the  label
      bear the  caution  "Keep out of
      ponds or streams. Do not cont
      water by cleaning of equipment 01
      posal of wastes."
        (ill) Physical or chemical hau
      Warning statements on the flama
      ity  or explosive characteristics of
      pesticide are required as follows:
              Fiaan
                   Raquradtaxt
                              (A)
Flaan pom « or Batow 3ST f-. t mare « a Raanoack it  Enramaly flammaota. Contains unoar prasaura. Kacp m
 any vafcw opaftng.                       \  *«. marks, ana h«MM wrfacaa. Do net punoura or n
                                    i  coraamar. Exposure to tampanuuras aeo»a 130* F
                                    !  BuMng.
Fits* port aMM 20* f and not o»ar 80* F or * ma \ Flammaow. Comants undar praaawa. Kaap away  ten
 ftama artamion a men man 1> in long at a Guinea •  sparks, and opan flama. Oo not punoura or ffenarata a
 el • in-lrom tna flama:                     j  Exooawa to temparatt»ea too** 130* F  may CBUM t
                                     Comantt unoar praaaura. Oo noc uaa or wora mar naata
                                      Kama. Oo not pgncajra or inonanta «oiua»iar.  £901
                                      tamparaajras aao«a 130* F may eauaa bmong.
                             (B) Nn>»aiiiii«mn COHTUM***
At or bao» 20*
                                    I Euramaty nammarta. Kaao away from Ara. »aru. and
ABOW 20* F and not ovar 8
-------
                            Appendix IV-1  (continued)
§162.10

for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing' processes.
provided that:
  U) The label clearly shows that the
product  is intended  for  use  only in
manufacturing processes and specifies
the type
-------
                                 Appendix  IV-1 (continued)
Chapter 1—Environmental Protection Agency
     Other  pertinent  information
which the  Administrator determines
to be necessary for the protection of
man and the environment.
  (j) Statement  of Use Classification.
By October  22.1976. all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (JX1) and (2)  of this
section.  Any pesticide  product  for
which some uses are classified for gen-
eral use and others for restricted use
shall  be separately labeled  according
to the labeling standards set forth in
this subsection,  and shall be marketed
as separate products  with different
registration numbers, one bearing di-
rections  only for general use(s) and
the other  bearing directions  for re-
stricted use<5) except that, if a product
has both restricted use(s) and general
use(s). both of these uses may appear
on a product labeled for restricted use.
Such  products shall be subject  to the
provisions of i 162.KKJX2).
  (1) General Use Classification. Pesti-
cide products bearing directions for
use(s) classified  ceneral shall  be la*
beled with  the  exact words "General
Classification" 'mmediately below the
heading "Oiret tions for Use." And ref-
erence to  the  general  classification
that suggests or implies that the gen-
eral utility  of the  pesticide extends
beyond those purposes and uses con-
tained in the Directions for Use  will be
considered a false or misleading state-
ment under the statutory definitions
of misbranding.
  (2)  Restricted  Use  Classification.
Pesticide  products bearing direction
for use(s)   classified restricted shall
bear statements of restricted use das-'
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 requi
 for  human hazard signal words (
 table in § 162.10(h)(lXiv)). and app«
 ing with sufficient prominence relat
 to other text and graphic material
 the front panel to make it unlikely
 be overlooked under customary con
 tions of purchase and use, the su
 ment "Restricted Use. Pesticide" si
 appear.  '
   (B) Directly below this statement
 the  front panel, a summary statenn
 of the  terms of restriction imposed
 a precondition  to registration  si
 appear. If use is restricted to certifl
 applicators, the following statement
 required: "For  retail sale to and
 only by Certified Applicators or p
 sons under their direct supervision a
 only for those uses covered by the C
 tified   Applicator's certification,"
 however, other regulatory restrict!!
 are  imposed, the Administrator i
 define the appropriate wording fort
 terms of restriction by regulation.
   (k) Advertising. [Reserved]

.[40 PR 28268. July 3, 1975: 40 PR 33
 AUK. 1. 1979: 40 FR 36571. Aug. 21. 197!,
 amended at 43 FR 5786. Feb. 9.19781

     Lll  Criteria for determinations of
        unable advene effects.
         teria for  Issuance of Not
  (a)
Intent
Repist
(1)
sumption
intent to
section 3(c)(
intent to
to section
notice of  intent
determine whet
should be cancel!
propriate, shall
termination by t
the pesticide m<
the criteria
graph (a)(3)
determinati
shall
the appli
may be,
regis'
su
P
                 Registration,  Cq
                • to Hold a Heat
                ', (i) A rebuttahfe pi
                arise  that a notice
               registration
               of the Act,/ notice
                 registration pursui
                 )  of tlfe  Act. or
                    ho]* a hearing
                          registratl!
                        denied, as
                       led. upon at
                       inistrator th
                    or*
be
                    set
         :ceeds any
         irth  in pai
                su
               itrati
  by certifie\ mail
               ,eca
that the applicant
 the  opportune
 in rebuttal  of
               this sectlor
                  the
          on in accordance with
       (a)(4) of this section. The apt
     or registrant shall have f orty-fi
                   96

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

Above signal
word
Immediately
below child
hazard
warning
COMMENTS
t
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc. '
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
•
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
                         97

-------
                                 AfiBENDIX IV-2  (Continued)
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Envi ronmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.

Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
I
(
,
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
98

-------
                                APPENDIX IV-2 (Continued)
ITEM
8C
9A
9C
10A
IOC
10D
U.S.
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
cholines terase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
statement of
classifica-
tion or
ahead of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
•
Preferably
blocked

Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
I
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
•
^
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
99

-------
                            S1MPT2

                PRODUCT

                 NAME
i 	Vfi
                       USE.
                 pssncce

                PRODUCT
                  NAME
                                              Seatrl ctad 7ae r-s-tl
                               100

-------
                                                   Appendix  IV-3
                    PHYSICAL-CHEMICAL HAZARDS
Criteria
I.  Pressurized Containers
    A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
    B,
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more tnan 13 incnes
long at a distance of
6 inches from the
valve opening.

ALL OTHER PRESSURIZED
CONTAINERS
II.  Non-Pressurized Containers

    A.  Flashpoint at or below
        20°F.
    B.  Flasnpoint above 20 °F
        and over 80°F.

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

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

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

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

                              Flammable.  Keep away from
                              heat and open flame.

                              Do not use or store near
                              heat and open flame.

                              None required.
                                101

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                                               Appendix  iv-4

       STORAGE AND DISPOSAL INSTRUCTIONS  FOR PESTICIDES

All products are required to bear specific  label  instructions
about storage and disposal.  Storage and  disposal instructions
must be grouped together in tne directions  for use portion of
tne label under'the Heading STORAGE AND DISPOSAL.  Products
intended solely for domestic use need  not include tne Heading
"STORAGE AND DISPOSAL."  The STORAGE AND  DISPOSAL heading
must appear in the minimum type size listed below:
 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	8 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,
Eacn 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 handl'ing  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.

                                  102

-------
                                                 Appendix  iv-4
                                                 (continued)

4.  Instructions on wnat 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 otner
    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 tne
    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:


                              103

-------
                                                 Appendix iv-4
                                                 (continued)

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

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

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

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

C.  Container Disposal Instructions

    Tne label of eacft product must bear container disposal
    instructions appropriate to tne type of container.

    1.  All products intended for domestic use must bear one
        of tne following container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trasft.
Do not reuse bag. Discard bag in trasn.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
                                104

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                                                Appendix
                                                (continued)
   2.  The labels for all other products must bear container disposal
       instructions, based on container type, listed below:
Container Type
                 Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent).  Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
otner procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent).  Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning.  If burned,
stay out of smoke.	
Glass containers
Triple rinse (or equivalent).  Then dispose
of in a sanitary landfill or by other
approved state and local procedures.	
Container Type
                 Statement
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Completely empty liner by shaJcing 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
reused1, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill oir 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 may replace this phrase with one indicating whether
    and how fiber drum may be reused.


  2. The labels for all other products must bear container
     disposal instructions, based on container type, listed
     on the first page of this Appendix.
                            105

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                                                 Appendix IV-4
                                                 (continued)


Pesticides that are hazardous wastes under 40 CFR 261.33(e) and (f)
when discarded.

      "Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
                   Active Ingredients, (no inerts);

Acroiein
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
Oieldrin
0,0-Diethyl S-[2-ethyIthio)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-cyclohexylpnenol
2,4 Dinitrophenol
Oinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methorny1
alpha-Naphthylthiourea  (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide  (OMPA, schradan)
Parathion

                             106

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

Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate   (sulfotepp)
Tetraetnyl 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).
                                107

-------
                                                 Appendix IV-4-
                                                 (continued)
        "Toxic" Commercial Pesticide Products (RCRA "F* List)
                         Active Ingredients:

Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)ptnalate
Cacodylic acid
Carbon tetracbloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclonexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c,d]-pentalen-2-one
    (Jcepone, cnlordecone)
1,2-Dibromo-3-chloropropane  (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12 )
3,5-Dichloro-N-(1rl-dimethyl-2-propynyl) benzamide  (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 4f4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide  (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
                                   108

-------
                                                 Appendix
                                                  (continued)
        "Toxic" Commercial Pesticide Products   (RCRA  "F"  List)
                         Active Ingredients:

Isobutyl alconol
Lead acetate
Lindane
Maleic nydrazide
Mercury
Metnyl alcohol
Metnyl bromide
Metnyl cnloride
2,2'-Metnylenebis (3,4,6-tricnloropnenol)   (nexacnlorophene)
Metnylene cnloride
Metnyl etnyl Ice tone
4-Metnyl-2-pentanone (metnyl isobutyl Icetone)
Napntnalene
Nitrobenzene
p-Nitrophenol
Pentacnloroetnane
Pentacnloronitrobenzene  (PCNB)
Pentacloropnenol
Pnenol
Pnospnoroditnioic acid, 0,0-dietnyl, metnyl ester
Propylene dicnloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4 r5-Tfetracttlorobenzene
1e1f2,2-Tetracnloroetnane
Tetracnlorcetnylene
2,3,4,6-Tetracftloropnenol
Ttiiram
Toluene
1,1,i-Tricnloroetnane
Tricnloroetnylene
Tricnloromonofluorometnane  (Freon 11 )
2,4,5-Tricnloropnenol
2,4,6-Tricnloropnenol
2,4,5-Tricnloropftenoxyacetic acid  (2,4,5-T)
Xylene
                             109

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                                               Appendix IV-4
                                               (continued)
'Toxic" Commercial' Pesticide Products  (RCRA  "F" List)
 Inert Ingredients;
Acetone
Acetonitrile
Ace topne none
Acrylic acid
Aniline
Benzene
Chlorobenzene
Cnloroforra
Cyclonexane
Cyclonexanone
Dicnlorodifluororaetiiane  (Freon 12  )
Dietnyl pntnalate
Dimetnylamine
Dimetnyl pntnalate
1,4-Dioxane
Etnylene oxide
Formaldenyde
Formic acid
Isooutyl alconol
Meleic anhydride
Metnyl alconol (metnanol)
Metftyl etnyl ketone
Metnyl metnacrylate
Napntnalene
Saccnarin and salts
Thiourea
Toluene
1,1,1-Tricnloroetnane
1,1,2-Tri cnloroe tnane
Tricnlorofluororaetnane (Freon
Vinyl cnloride
Xylene
                            110

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

                                   CAPTAFOL*

TYPE PESTICIDE;  Fungicide/Acaricide

FORMULATIONS;  Tech (97%); D (35%, 60%, 65%); WP (25%, 70%, 80%);
               EC (39%); F1C (27%, 4 Ib/gal)

GENERAL WARNINGS AND LIMITATIONS;  Dosage rates are expressed in active
ingredient (exceptions are registration number 3008-27 which is used for
surface mold control and 239-2313 listing uses for peach and nectarine).

Agricultural Crop Tolerances;  All are listed at individual crop sites.
Site and Pest
AGRICULTURAL CROPS
  Apple
    Apple scab
      (venturia)
Dosages and   Tolerance, Use, Limitations
Formulation(s)
              0.25 ppm
              No preharvest interval through
              12.0 pounds per acre.  Do not
              prune following captafol
              application.  Do not apply oil
              after captafol application as
              phytotoxicity may occur.  Captafol
              applications later than 1/4 inch
              green tip stage may produce foliage
              injury and/or fruit russeting.
0.8 lb/100
 gal
[use up to
 600 gal/A]
(80% WP)

12.0-20.0 lb/
 A [Use 100
 to 400 gal]
(4.0 Ib/gal
 F1C)
(80% WP -
 granular
 size)
Dormant or delayed dormant applica-
tion.  Apply a single spray at up
to 1/4 inch green tip stage
of growth.
                                       /04001AA
FEAJVAG
                                       Use limited to Midwestern and
                                       Eastern States.  Dormant or delayed
                                       dormant application.  Make a single
                                       application during dormant period
                                       or up to 1/4 inch green tip stage.
                                       Use the higher rates and gallonage
                                       for larger trees.  This application
                                       gives scab protection through the pink
                                       stage.  For later scab protection, use
                                       another suitable fungicide.
* (cis-N- ((1,1,2,2, -tetrachloroethyl) thio) -4 cyclohexene-1,2,-dicarboximide)
Issued; 09-24-81
Revised; 08-24-84
           11-081701- 1

-------
                        EPA Index to Pesticide Chemicals
Site and Pest
  Apple (continued)
  Apricot
   Scab  (Cladosporium)
   Brown rot blossom
     blight
  Blueberry
    Fusicoccum canker
          CAPTAFOL

Dosage and    Tolerance, Use, Limitations
Formulation(s)
                         5.0 lb/100
                          gal
                          [use up to
                          400 gal/A]
                          (4.0 Ib/gal
                          F1C)
 400 gal/A
(80% WP)
   or
1.5 fl oz
 (3 tbls)
27% FlC/gal
(27% F1C)

0.8-1.0 lb/
 100 gal
(80% WP)
2-4 Ib/A
[use 20-250
 gal/A]
(4.0 Ib/gal
 F1C)
(80% WP -
 granular
 size)
Use limited to Midwestern and
Eastern States.  Dormant or
delayed dormant application.
Make a single application during
dormant period or at up to 1/4 inch
green tip stage.  Use the higher
gallonage for larger trees.  This
application gives scab protection
up to petal fall.  For later scab
protection, use another suitable
fungicide.

30 ppm                                 /05001AA
No preharvest interval through
12.8 pounds per acre.

rates in fall before rains begin
and repeat in late winter prior to
bud swell or apply higher rates as
single treatment after leaves have
dropped or prior to fall rains.
Delayed dormant and foliar             FEAJCCV
application.  Use sufficient spray     FBADMCB
per acre depending on size of tree
to provide full coverage.  Apply
at prebloom, full bloom, petal fall
and shuck split and repeat at 10 to
14 day intervals though harvest.  Do
not apply after shuck split in
California, Oregon, or Washington,
or if fruit is to be dried.

25 ppm                                 /01009AA
21 day preharvest interval through
4.0 pounds per acre.

Delayed dormant and foliar applica-    FDAAFAN
tion.  Begin applications at bud
break and repeat at 4 to 6 week
intervals.  Resume application immedi-
ately after harvest and continue
through leaf drop.
Issued: 09-24-81
Revised: 08-24-84
           II-081701-2

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                        EPA Index to Pesticide Chemicals
Site and Pest
  Blueberry (continued)

    Mumnyberry
    Phomopsis twig
      blight
    Anthracnose fruit
      rot
  Cherry (sweet)
    Brown rot blossom
     blight
  Cherry (sour)
    Cherry leaf spot
     (cocccmyces)
            CAPTAPOL

 Dosages and   Tolerance, Usef Limitations
 Formulation(s)
 2-4 Ib/A
 [use 20-250
  gal/A]
 (4.0 Ib/gal
  F1C)
 (80% WP -
  granular
  size)

 2-4 Ib/A
[use 20-250
 gal/A]
(4.0 Ib/gal
 F1C)
(80% WP -
 granular
 size)
0.8-1.6 lb/
 100 gal
(80% WP)
 0.4-1.0 lb/
  100 gal
 (80% WP)
 (80% WP -
  granular
  size)
Delayed dormant and foliar
applications.  Begin applications
at early green tip stage and repeat
at 1 to 2 week intervals throughout
petal fall.
FIBMMCB
FBAEPBU
Foliar application.
Begin applications at full bloom and
repeat at 10 to 20 day intervals.
FAAAGAN
2 ppm                                  /05002AA
No preharvest interval through 1.6
pounds per 100 gallons.

Use limited to California and Oregon.  FBADMCB
Delayed dormant and foliar appli-
cation.  Use sufficient spray per acre
depending on tree size to provide
thorough coverage.  Apply at prebloom,
bloom and petal fall.

50 ppm                                 /05002AA
No preharvest interval through 9.0
pounds per acre.

Foliar application.  Use sufficient    FMBCCDJ
spray per acre depending on the tree
size, to provide thorough coverage.
Begin applications at petal fall and
repeat at 10 day intervals for 3 to
4 applications, then make a final
application to the foliage after
harvest.
Issued: 09-24-81
Revised: 08-24-84
            II-081701-3

-------
Site and Pest
  Cherry (sour)
    (continued)

    Brown rot blossom
      blight
    Brown rot fruit
      rot
    Cherry leaf spot
       (Coccomyces)
EPA Index to Pesticide Chemicals

            CAPTAPOL

 Dosages and   Tolerance/ Usef Limitation
 Pormulation(s)

               Use limited to Monmorency variety -
               to be mechanically harvested.

1.0 lb/100     Foliar application.                    FBADMCB
 gal           Use sufficient spray per acre,
(4 Ib/gal      depending on the tree size, to
 FlC)          provide thorough coverage.  Begin
(80% WP -      applications at popcorn stage of
 granular      blossom development.  During periods
 size)         of wet weather repeat application at
               2 to 4 day intervals through petal
               fall.

1.0 lb/100     Foliar application.                    FIALMCB
 gal           Apply during wet weather or when
(4 Ib/gal      conditions are favorable for disease
 FLC)          development.  Begin at petal fall or
(80% WP -      when leaves first unfold and repeat
 granular      at 10 day interval.  Do not exceed
 size)         4 applications.
                                                         •v.

0.5-1.0 lb/    (a) seasonal program and post harvest  FMBCCDJ
 100 gal       control.  Foliar application.  Use
(4 Ib/gal FlC) sufficient spray per acre for thorough
               coverage.  Begin application at petal
               fall or when leaves unfold and repeat
               at approximately 10 day intervals for
               3 to 4 applications.  Make one applica-
               tion after harvest.  Use the higher
               rate during periods of wet weather or
               when conditions are favorable for
               disease development.

3 lb/100 gal   (b) Reduced application program.
[up to 300     Foliar application.  Use maximum
 gal/A]        gallonage on mature trees.  Make
(4 Ib/gal FlC) single application at petal fall or
               when leaves unfold for control
               through harvest.
Issued: 9-24-81
Revised: 08-24-84
           II-081701-4

-------
                        EPA Index to Pesticide Chemicals
Site and Pest
  Corn (field)

    Damping off and
    seed rot
  Cotton

   (Acid delinted seed)
    Damping-off and
     seed rot
   (Machine delinted
    seed)
    Damping-off and
     seed rot
  Cranberry
    Fruit Rot
  Cucumber
           CAPTAFOL

Dosage and    Tolerance, Use, Limitations
Formulation(s)

              N.F.

0.47 oz/bu    Seed treatment.  Apply as a water
    or        slurry.
0.875 oz/100
 Ib
(70% WP)
                                                     /28006AA

                                                     FKAIQBB
              N.F.
                                                     /28007AA
0.094 Ib/
100 Ib seed
(4 Ib/gal
 F1C)
Seed treatment.  For use in slurry
treaters.  Do not allow to stand over-
night.  Clean out equipment thoroughly
between treating operations.  Shake,
roll or agitate container to improve
uniformity.
                                                     FKAIQBB
 Ib seed
(4 Ib/gal
 F1C)
0.141 lb/100  Seed treatment.  For use in slurry     FKAIQBB
              treaters.  Do not allow to stand over-
              night.  Clean out equipment thoroughly
              between treating operations.  Shake,
              roll or agitate container to improve
              uniformity.

              8 ppm                                  /01010AA
              50 day preharvest interval through
              5.0 pounds per acre.

              Foliar applications.  Vary the rate    FIBFQBB
              according to the plant size.  Apply
              at bloom and repeat at 10 to 14 day
              intervals for a total of 3 appli-
              cations each year.
3-5 lb/100-
300 gal/A
(4 Ib/gal
 F1C)
(80% WP -
 granular
 size)
              2 ppm                                  /10010AA
              No preharvest interval through 3.5
              pounds per acre.
Issued: 09-24-81
Revised: 08-24-84
           II-081701-5

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                        EPA Index to Pesticide Chemicals
Site and Pest

  Cucumber (continued)

    Alternaria leaf
     blight
    Anthracnose
    Downy mildew
    Gummy stem blight
     blight
    Scab

    Fruit rot
     (Belly rot)
           CAPTAPOL

Dosage and    Tolerance, Use, Limitations
Pormulation(s)
1.20-1.6 Ib
 A
[Use 50-150
 gal/A]
(4 Ib/gal
 F1C)
(80% WP)

3.25 Ib/A
[use 30-50
 gal/A]
(4 Ib/gal
 F1C)
                                       Foliar application.  Apply when        FBATAAX
                                       first tree leaves appear and continue
                                       at weekly intervals.  Adjust rate of   FAAACDP
                                       water per acre used to obtain          FFABPEA
                                       thorough coverage.                     FBACMCO

                                                                              FFAJCCV
  Grapefruit
  Lemon
  Lime
  Orange  (including Murcott Honey
          and Temple cultivars)
  Tangerines
    Melanose
    Scab
    Citrus  rust mite*
                                       Use limited to Southeastern United     FIACRAM
                                       States.  Foliar and soil application.
                                       Make at single application after last
                                       cultivation or when vines begin to
                                       run.  Direct spray to the bed soil.

                                       0.5 ppm                                /02002AA
                                       Do not apply to any citrus when        /02004M
                                       mature fruits are on the tree.  Do     /02005AA
                                       not concentrate more than 2 times      /02006AA
                                       when tank mixing with Boron
                                       formulations.  Do not tank mix         /02008AA
                                       with Boron or technical manganese
                                       formulations for aerial application.
                                       Nixing captafol and spray oils will
                                       cause phytotoxicity.

                                       Use limited to Florida on fruit        FIBLDAP
                                       for processing.  Foliar application.   FEAJEAH
                                       Apply up to 2000 gallons per acre,     ILAJBCA
                                       depending on the size of tree or
                                       or equivalent amount per acre as a
                                       concentrate spray.  Use the higher
                                       rate on groves with a history of
                                       severe scab.

                                       Foliar applicaton by air.  Use a
                                       suitable spreader-sticker.  Do not
                                       concentrate more than 1:1 with water,
                                       or use 10 gallons finished spray per
                                       acre.  Apply as a delayed dormant spray
                                       after crop harvest and crop hedging or
                                       pruning.  Apply only in groves equipped
                                       with overhead irrigation since rain-
                                       fall or overhead irrigation during
                                       dry seasons is required to redistribute
                                       the captafol to newly developed leaf
                                       and fruit growth.

*"rust mite" control is an acaricidal (insecticidal) claim, not fungicidal.
3.2-4.0 Ib/
100 gal
[use up to
 2000 gal/A]
(4 Ib/gal
 F1C)
                           12  lb/10
                           gal/A
                           (4  Ib/gal
                            F1C)
Issued: 09-24-81
Revised: 08-24-84
          11-081701-6

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                        EPA Index to Pesticide Chemicals
Site and Pest
  Grapefruit
  Orange
  Tangerine
    Melanose
    Scab
  Macadamia Nuts
    Raceme (Blossom
     blight) (Botrytis)
           CAPTAFOL

Dosage and    Tolerance, Use, Limitations
Formulation(s)

              0.5 ppm
              Do not apply to any citrus when
              mature fruits are on the trees.
              Captafol can cause a rind spotting
              when applied to young citrus fruit.
              Do not concentrate sprays above
              6 times the ground concentration
              when tank mixing with Boron formu-
              lations.  Do not mix captafol
              and spray oils.  Do not tank mix
              with Boron for aerial application.
                                       /02002AA
                                       /02006AA
                                       /02008AA
0.8-1.0 lb/
100 gal
[use up to
 2000 gal/A]
(4 Ib/gal
 F1C)
                         5.0 lb/10
                         gal/A
                         (4 Ib/gal
                          F1C)
1.6 lb/100
gal [use 700
gal/A]
    or
1.6 lb/10
gal [use 70
gal/A] for
mist blower
application
(80% WP)
    or
11 lb/700
gal/A
    or
Use limited to Florida to fruit
for processing.  Foliar application.
Use maximum gallonage for larger
trees or equivalent amount per acre
as a concentrate spray.  Use higher
rate on groves with a history of
severe melanose.
             V.

Foliar application by air.  Use on
orange or temple oranges for
processing and on temple oranges for
fresh market.  Apply as a post-bloom
spray (from 2/3 petal fall to 3 weeks
after petal fall).

0.1 ppm
No preharvest interval through 11.2
pounds per acre.

Use limited to Hawaii.  Delayed
dormant & foliar application.
Apply at weekly intervals during the
bloom period of February and March.
Apply twice weekly during periods
of severe infection.  Follow small
gallonage recommendation for mist
applications.
FIBLDAP
FEAJEAH
                                                     /03007AA
FBADBAW
  Issued: 09-24-81
  Revised: 08-24-84
          11-081701- 7

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Site and Pest
  Macadcmia Nuts
    (continued)
  Melons  (cantaloupe,
   honey  dew, musk-
   melon  & others)

    Alternaria  leaf
     blight
    Downy mildew
    Anthracnose
    Gummy stem  blight
  Nectarine

    Coryneum blight
    Peach  leaf curl
  Onion
    Purple  blotch
    Downy mildew
    Botrytis  (blight)
EPA Index to Pesticide Chemicals

            CAPTAPOL

 Dosage and    Tolerance, Use, Limitations
 Formulations
 11 lb/70
 gal/A
 for mist
 blower appli-
 cation
 (4 Ib/gal flC)

               5 ppm
               No preharvest interval through 2.5
               pounds per acre.

 1.25-2.5 lb/  Foliar application.  Apply gallonage
 A [use 100    level as required to obtain through
               coverage.  Begin application when
               first tree leaves appear and repeat
               at weekly intervals.
                                                     /10001AA
to 150 gal/
A]
(80% WP)
(4 Ib/gal
FlC)
 6.4-12.8 lb/
 A
 (80% WP)
     or
 1.5 fl. oz.
  27% FlC/gal
 (27% FlC)
 1.25 lb/100
 gal/A
 (4 Ib/gal
              2 ppm

              Dormant application.  Use up to 400
              gallons water per acre or sufficient
              water to cover.  Apply lower rate in
              the fall before rains begin and
              repeat in late winter prior to bud
              swell; or apply the higher rate as
              a single treatment after leaves have
              dropped prior to fall rains.

              0.1 ppm
              No preharvest interval through 1.25
              pounds per acre.

              Foliar application.  Begin applica-
              tions when disease first appears and
              repeat at 7-10 day intervals.
FBATAAX
FFABPEA
FAAACDP
FBAQMCO
/05003AA

FBAZCEL
FEAGTAB
                                                      /14011AA
FCAEAAX
FFABPAU
FBAABAW
  Issued: 09-24-81
  Revised: 08-24-84
          11-081701- 8

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Site and Pest
EPA Index to Pesticide Chemicals

            CAPTAPOL

 Dosage and    Tolerance, Usey Limitations
 Formulation(s)
  Peach

    Coryneum blight
    Peach leaf curl
 Peanut
  Cercospora leafspot
 6.4-12.8
 Ib/A
 (80% WP)
    or
  1.5 fl. oz.
  27% FlC/gal
  (27% FlC)
  Damping off and seed
   rot (Aspergillus)
  Damping off and seed
   rot (Rhizopus)
  Damping off and seed
   rot

Pineapple
 1.5 Ib/A
 [use 10-60
  gal/A
  ground
  equip, or
  5-10 gal/
  A aerial]
 (4 Ib/gal
  FlC)

 0.11-0.2 Ib
 /100 Ib seed
 (35% D)
 (60% D)
 (65% D)
30 ppm

Dormant application.  Use up to
400 gallons water per acre or
sufficient water to cover.  Apply
lower rate in the fall before rains
begin and repeat in late winter prior
to bud swell; or apply the higher
rate as a single treatment after
leaves have dropped prior to fall
rains.

2 ppm (in hulls)
0.05 ppm (hulls removed)
14 day preharvest interval through
1.5 pounds per acre.  Do not graze
treated area or feed treated vines or
hay to livestock.  Do not hog down
treated areas.

Foliar application.  Apply when
disease first appears (25-45 days
post-plant).  Repeat at 10-14 day
intervals to maintain control.
                                      /05004AA

                                      FBAZCEL
                                      FEAGTAB
                                                      /28015AA
                                      FMBCCBM
Seed treatment.  Apply with
commerical treating machine for
uniform seed treatment coverage.
May be formulated with 2,6-
dichloro-4-nitroaniline.
                0.1 ppm
                No preharvest interval through
                31.25 pounds per acre.
                                       FKAIACG

                                       FKAIRAQ

                                       FKAIQBB


                                       /06013AA
Issued: 09-24-81
Revised: 08-24-84
          11-081701-9

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                        EPA Index to Pesticide Chemicals
Site and Pest


  Pineapple  (continued)

    Pineapple heart rot
Plum
Prune
  Brown rot blossom
   blight
Potato
  Early blight
  Late blight
Rice
           CAPTAFOL

Dosage and    Tolerance, Use, Limitations
Formulation(s)
1.25 lb/10
gal mixture
(4 Ib/gal
 F1C)
(80% WP)

8 lb/400
gal/A
(4 Ib/gal
 F1C)
Dip treatment.  Dip slips immediate-
ly before planting using 100 to 250
gallons dip per acre.
Soil application.  Apply first
application immediately after plant-
ing; repeat at monthly intervals for
a maximum of 8 applications.

2 ppm
No preharvest interval through 1.6
pounds per 100 gallons.

Use limited to California and
Oregon.  Delayed dormant and foliar
application.  Use sufficient spray
per acre depending on tree size to
provide thorough coverage.  Apply at
prebloom, bloom and petal fall.

0.5 ppm
No preharvest interval through 1.6
pounds per acre.
0.75-1.6 Ib/A  Foliar application.  Apply in
(4 Ib/gal FlC) sufficient water to cover.  Begin
FIBIPCN
0.75-1.6 Ib
 100 gal
(80 WP)
                          (80% WP)
                          (25% WP)
  Seed rot and seedling  0.125-0.188
   disease (Achlya)        lb/100 Ib
  Seed rot and seedling   seed
   disease (Pythium)      (4 Ib/gal
  Seed rot and            FlC)
   seedling disease
   (HeLninthosporum)
               when plants are 6 inches high and
               continue at 5 to 10 day intervals.
               Under severe disease condition use
               higher listed dosage and shorter
               spray intervals.  May be formulated
               with captan.

               N.F.

               Seed treatment.  Treat seeds prior
               to pre-soaking when planting in
               flooded fields.
                                                     /05005AA
                                                     /05006AA
FBADMCB
                                                     /14013AA
                                      FBAMAAX
                                      FBASPCN
                                       /28072AA

                                      FKAFADD

                                      FKAFPES

                                      FKAFHAM
 Issued:  09-24-84
 Revised:  08-24-84
          11-081701- 10

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Site and Pest
Sorghum (grain and
         forage)

  Damping-off and
  seed rot

Sweet Corn
EPA Index to Pesticide Chemicals

            CAPTAFOL

 Dosage and    Tolerance, Use, Limitations
 Formulation(s?
 2.1 oz/100
  Ib
 (70% WP)
  Northern corn leaf
   blight
  Southern corn leaf
   blight
 0.38-1.0 Ib/
  A
 (4 Ib/gal
  F1C)
Taro (wetland)
  Phytophthora leaf
   blight
 0.75-1.5 Ib/
 100 gal/A
 (4 Ib/gal
  F1C)
               N.F.
Seed treatment.
slurry.
Apply as a water
0.1 ppm
5 day preharvest interval through
1.0 pound per acre.  Use limited
to Florida.  For fresh vegetable
use only.  Do not feed treated
forage to livestock or allow
animals to graze treated area.

Foliar application by air.  Use in
3 to 5 gallons as required for
thorough coverage.  When disease
conditions are prevalent use 0.38
to 0.5 pounds per acre on a 2 day
schedule to protect new growth.  As
a preventive or under light disease
conditions use 0.75 to 1.0 pound on
a 4 day schedule.

0.02 ppm
11 week preharvest interval through
1.5 pounds per acre.  Use limited to
Hawaii.  Do not apply more than 36
pounds captafol per acre per year.

Folair application.  Begin when
infection is expected (normally 3
months after planting) and repeat
at 7 to 14 day intervals until danger
of infection is passed (normally 5
months after first application).
Under very wet conditions, use the
higher dosage or the shorter spray
interval.  Under dry conditions,
treat at 14 to 21 day intervals.
                                       /28019AA
FKAIQBB
                                                      /15005AA
                      FBATSBP

                      FBATCDM
                                                      /14006AA
                      FBATPCN
Issued: 09-24-81
Revised: 08-24-84
          11-081701-11

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                        EPA Index to Pesticide Chemicals
Site and Pest
  Totiato
    Anthracnose
    Early blight
    Fruit rot
    Gray leaf mold
    (Stemphylium)
    Late blight
    Nailhead spot
    Anthracnose fruit
     rot
    Black mold
    (Alternaria
     alternata)
           CAPTAPOL

Dosage and    Tolerance, Use, Limitations
Formulation(s)

              15.0 ppm
              No preharvest interval through
              16 pounds per acre.  Use limited
              to mechanically harvested tomatoes.
              Immature fruit may be spotted when
              captafol is combined with insecti-
              cides during periods of high
              temperature or drought stress.
                                       /11005AA
1.2-2.5 lb/
[use 30-150
 gal/A for
 ground
 equipment
 or 5-100
 gal/A by
 air]
 (4 Ib/gal
  F1C)
 (80% WP)

 8-16 Ib/A
 (4 Ib/gal
  F1C)
 1-2 Ib/A
 [use 30-200
  gal/A by
  ground or
  10 gal/A
  by air]
 (4 Ib/gal
  F1C)
Apply when first fruits are well
formed and repeat at 7 to 10 day
intervals.  When weather conditions
favor disease development, use
higher rate and begin application
when plants are set in fields.
FAAACDP
FBAMAAX
FBASPCN
FMAXSDG

FMBFAAX
FIBFQAB
Foliar application.  Apply as a
single spray when the first fruits
are formed; or use 4 to 8 pounds
actual in two applications.  Apply
the first treatment when first fruits
are formed followed by a second
treatment 20 days later.

Use limited to California. Foliar
application.  Apply when first fruits
are well formed and repeat at 7 to
10 day intervals.
FAAACDP
FIBFAAX
Issued: 09-24-81
Revised: 08-24-84
           11-081701- 12

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                        EPA Index To Pesticide Chemicals
Site and Pest
  Watermelon
    Anthracnose
    Downy mildew
    Gummy stem blight
           CAPTAFOL

Dosage and    Tolerance, Usey Limitations
Formulat ion(s)

              5.0 ppm
              No preharvest interval through 2.5
              pounds per acre.

 1.2-2.5 lb/  Foliar application.
 [use in 50-
  150 gal/A]
 (4 Ib/gal
  F1C)
 (80% WP)
Begin applications when plants start
to vine and repeat at 5-10 day
intervals as needed.  Use lower
gallonage for initial application and
increase for thorough coverage depend-
ing upon plant size.
                                       /10008AA
FAAACDP
FFABPEA
FBAQMCO
STRUCTURE, WOOD PRODUCTS AND WOOD COMMODITIES

  Wood Protection treatment by pressure
                                                     /640100AA
    Surface mold
1-2 pints 39% Wood protection treatment by pressure.
                         EC/300 gal
                         preservative
                         solution.
                         (39% EC)
AERIAL AND TANK MIX APPLICATIONS
  Aerial Application
              Add one pint of the formulation to 300
              gallons ready to use wood preserving
              solution for pressure treatment of
              wood.  (Wood preserving solutions of
              0.5 to 6.0 percent concentration of
              copper-chrome arsenate or fluoride-
              chrcme arsenate-phenol preservative
              in water are suitable for use.  This
              gives the recommended minimum of 200
              ppm active ingredient concentration.)
              Under extremely hot humid conditions,
              the concentration may be doubled to get
              the required control.
                                                     9001500
                                                     AAAAAAA
                        Refer to
                        AGRICULTURAL CROPS
                                      Peanuts,  sweet corn, tomato
Issued: 09-24-81
Revised: 08-24-84
            11-081701- 13

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                        EPA Index to Pesticide Chemicals

                                    CAPTAFOL

Listing of Registered Pesticide Products by Formulation

97% technical chemical
  captafol (081701)
    000239-02230

35% dust
  captafol (082701) plus 2,6-dichloro-4-nitroaniline (031301)
    000239-02273

60% dust
  captafol (081701) plus 2,6-dichloro-4-nitroaniline (031301)
    000239-02407

65% dust
  captafol (081701)
    000239-02198

25% wettable powder
  captafol (081701) plus captan (081301)
    000239-02195

70% wettable powder
  captafol (081701) plus methoxychlor (034001)
    000239-02409

80% wettable powder
  captafol (081701)
    000239-01716    000239-02217

80% wettable powder (granular size)
  captafol (081701)
    000239-02495

39% emulsifiable concentrate
  captafol (081701)
    003008-00027

27% flowable concentrate
  captafol (081701)
    000239-02313

4 Ib/gal flowable concentrate
  captafol (081701)
    000239-02211    000239-02369
Issued: 09-24-81                  11-081701- 14
Revised: 08-24-84

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EPA Index to Pesticide Chemicals

            CAPTAPOL
State Label Registration

  CA Reg. No.
    000239-04198

  HI Reg. No.
    000239-04168    037843-08576

  NY Reg. No.
    038655-10453
                                                      9999999
Issued: 09-24-81
Revised: 08-24-84
            11-081701-15

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Auxiliary documentation:  Summary

  Site

  Citrus (bark treatment)

  Citrus (soil treatment)


  Corn  (seed treatment)



  Peanuts  (foliar treatment)

  Pineapple (foliar  treatment)
  Pineapple (dip treatment)

  Potato (water treatment)
EPA Index to Pesticide Chemicals

           CAPTAFOL

          of 24c registrations by Crop.

              Pest

              Foot rot (Phytophthora)
  Strawberry  (nursery stock)
  Sugarcane  (growth  regulator)
             Not  Fungicidal

  Tomato  (soil  treatment, green-
    house)

  Watermelon (foliar treatment)
              Greasy spot
                (Mycosphaerella)

              Seed rot and seedling
                blight (Pythium,
                Rhizoctonia, Rhizopus)

              Leaf spot (Cercospora)

              Heart rot (Phytophthora)
              Heart rot (Phytophthora)
Accession number

FL800038

FL820033
FL780064
ID800050
TX770010

HI770006
HI770006
              Early blight (Alternaria)  OR810083
                                         WA780027
              Early blight (Alternaria)
              Late blight (Phytophthora) CO790018
                                         MI800016
                                         NE800016

              Anthracnose (Colletotrichum)
                                         AR790002

              stimulation of germination FL760012
              Fusarium crown and root    OH760002
                rot                      NC760003

              Anthracnose (Colletotrichum)
              Downy mildew (Pseudoperonospora)
              Gummy stem blight          TX780044
                (Mycosphaerella)
Issued: 08-24-84
        11-081701-16

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