GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS

             CONTAINING

              AMITROLE

      AS THE ACTIVE INGREDIENT
  ENVIRONMENTAL PROTECTION AGENCY
    OFFICE OF PESTICIDE PROGRAMS

      WASHINGTON, D.C.  20460

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                        TABLE_OF CONTENTS


      Introduction 	 1

I.    Regulatory Position	4

II.   Requirement for Submission of Generic Data	35

III.  Requirement for Submission of Product-Specific
      Data	38

IV.   Submission of Revised Labeling and Packaging
      Information	39

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

V.    Instructions for Submission	44

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                            APPENDICES


I         Bibliography

II        PIFRA s3(c)(2)(B) Summary Sheet - EPA Form 8580-1

III       Certification of Attempt to Enter Into an Agreement
          With Other Registrants for Development of Data
          EPA Form 8580-6

IV        Product Specific Data Report (End-Use Products)
          EPA Form 8580-4

V-l       40 CFR §162.10 Labeling Requirements

V-2       Table of Labeling Requirements and Sample Labels

V-3       Physical/Chemical Hazards Labeling Statement

V-4       Storage and Disposal Statements

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                         INTRODUCTION

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

     TO fulfill this Congressional mandate, we have established
the Registration Standards program which will review all pesti-
cide 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.  Amitrole is in the
H-7 herbicide cluster for chemicals used on drainage ditches,
rights-of-way, forests and ponds.

     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 available upon request, concentrates on the technical
grade of the active ingredient and identifies missing generic
data.  However, during the review of these data we are also
looking for potential hazards that may be associated with
the end-use (formulated) products that contain the active
ingredient. If we find serious concerns, we will bring
end-use products under the provisions of the Registration
Standards program to the extent necessary to protect the
public.

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

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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 regist-
rant's firm.  If the end-use product registrant decides to
switch sources, a new Confidential Statement of Formula, EPA
Form 8570-4, must be submitted to the appropriate Product
Manager within 90 days of receipt of this Guidance Document.
The chart on the following page shows what is generally
required of those who do and do not qualify for the formulator's
exemption in the Registration Standards program.

     If you decide to request the Agency to 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 may issue a notice of intent to cancel
or suspend the registration of any currently registered
product or deny any application for registration of a 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 Monsanto v. Acting Administrator, EPA was
enjoined from implementing §3(c)(l)(D) of FIFRA.  EPA has
decided that as long as this injunction is in effect, it will,
for most pesticides, proceed with the requirements in this
Guidance Document which do not require compliance with the
provisions of §3(c)(l)(D).  Despite this decision, EPA will
require current registrants to apply to amend their product
registrations to make changes in the labeling, packaging, or
composition for this chemical.  The Agency will supplement
the Document with additional guidance when this litigation
concludes.  Failure to comply with the provisions of the
subsequent guidance may also result in issuance by EPA of an
intent to cancel the affected product registration(s).

    Registrants are reminded that §6(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 adverse effects.

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  PRODUCTS SUBJECT TO THE
  REGISTRATION STANDARDS PROGRAM
I. Products That Do Not Qualify
   For The Formulator's Exemption

   A. Single Active Ingredient
      Products*  .
                                   ACTION(S) REQUIRED TO"
                                   MAINTAIN REGISTRATION
                                 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 will not be
                                 reregistered at this time.
                                 However, generic data required
                                 to continue the registration of
                                 the active ingredient under
                                 review, as described in the
                                 Registration Standards Guidance
                                 Document, will be required and
                                 some 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
requirements in I-A and B.	_^_____	

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         I.  REGULATORY POSITION AND RATIONALE

A.  INTRODUCTION

This chapter describes the regulatory position of the
Environmental Protection Agency ("the Agency") on amitrole,
based on an evaluation of all registered manufacturing-use
products (MUP's) containing amitrole as the sole active
ingredient.  Future requests for registrations of
substantially similar products will be covered by this
standard.  Dissimilar products will require amendments to
the standard.  This standard provides the rationale for the
Agency's position, the criteria for registration and also
discusses labeling requirements and tolerances.

In developing its regulatory position, the Agency determines
whether available data indicate that a pesticide has met
the criteria for unreasonable adverse effects found in
Section 162.11(a) of Title 40 of the U.S. Code of Federal
Regulations (CFR).  Pesticides meeting these criteria are
candidates for a Special Review, an intensive risk/benefit
analysis which a modification of the Rebuttable Presumption
Against Registration (RPAR) process.  The Agency's
determination as to whether any criteria have been met and
its rationale for any regulatory action are summarized in
the regulatory position of this standard.

"Amitrole" is the accepted common name for 3-amino-l,2,4-
triazole recognized by the American National Standards
Institute.  Trade and other names for amitrole include
Weedazole®, Amino Triazole Weed Killer®, Cytrol®, Amitrol
T®, Domatol®, Vorox®, Amizole®, X-All®, Ustinex®, AT, ATA,
Aminotriazole 90 and Chempar Amitrole. The Chemical Abstracts
Service (CAS) Registry number is 61-82-5.  The Office of
Pesticides Program's internal control number (EPA
Shaughnessy number) is 004401.

B.  USE PROFILE

Amitrole is a broad spectrum herbicide effective against a
wide range of monocotyledonous (grasses) and dicotyledonous
(broadleaf) weeds.  It was first registered in 1948 for use
on noncrop lands and in 1958 for use on cranberries on a no
residue basis for postharvest application only.

Amitrole is registered for use on a variety of noncrop
sites, including rights-of-way, marshes and drainage ditches,
ornamentals and around commercial, industrial, agricultural,
domestic, and recreational premises.  It is formulated into
a soluble concentrate/liquid (2 Ibs/gal), soluble concentrate/
solid (50 and 90%) and pressurized liquids (0.36 and 1%).

Amitrole is not currently registered for use on food crops.
Registrants were notified by EPA on June 16, 1971 that
registrations of all formulations containing amitrole and

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bearing use directions for food crops would be cancelled
because this chemical is a carcinogen in experimental
animals.  There are no tolerances for any food crop or
water which will be used for irrigation, drinking, or other
domestic purposes, and to date no new registrations or
establishment of tolerances for amitrole have been requested.

C.  REGULATORY POSITION

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

    1.   Amitrole has oncogenic potential and is a candidate
        for special Review.  Registrants of amitrole products
        are hereby notified that some uses of amitrole may
        have met the risk criterion for oncogenicity in 40
        CFR 162.11(a).  A Notice announcing the Agency's
        decision to initiate a Special Review will be
        published in the Federal Register.

    2.   The Agency will not reregister any current products
        and it will not register any new products containing
        amitrole at this time.

    3.   Except for homeowner uses, the oncogenic risk
        associated with all use patterns and application
        techniques of amitrole may be high and their continued
        general use may cause unreasonable adverse effects.
        Except for homeowner uses, all use patterns and
        application techniques are classified as restricted.

    4.   Registrants must alter labeling, as specified below,
        in order to maintain existing registrations or to
        permit new amitrole registrations.  Labeling must
        include a cancer warning statement and a requirement
        to use protective clothing to reduce risk during
        the period of pivotal data development and Special
        Review.

    5.   Within 90 days after receipt of this Standard,
        registrants must: (A) commit to perform all of the
        required studies, (B) complete labeling of all
        products to-be-released-for-shipment, (C) furnish
        all retailers and wholesalers of record with
        supplementary labeling for all products in channels-
        of-trade, and (D) submit copies of the above labeling
        to the Agency as evidence of compliance with this

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     Standard.  Within 180 days after receipt of this
     Standard, registrants must submit all pivotal data
     and initiate steps to fulfill the remaining data
     requirements.  All registrants, regardless of whether
     they intend to maintain their registrations, are
     required by this Standard to furnish all retailers
     and wholesalers of record with supplementary labeling
     for all products in channels-of-trade.

 6.  Manufacturing-use pesticide products containing
     amitrole as a sole active ingredient may, after
     further review, be registered for sale, distribution,
     formulation and use in the United States, subject
     to the terms and conditions specified in this standard,
     Registrants and applicants with products that do
     not conform to this standard must apply to amend the
     standard in order to reregister and register,
     respectively.  Mixtures and end-use products
     containing amitrole are covered under this standard
     for the purposes of labeling.  The use patterns of
     the end-use products are considered for purposes
     of determining generic data requirements for amitrole.

 7.  Registrants not qualifying for a formulator exemption
     must provide or agree to develop all data specified
     in the tables of this standard to maintain existing
     registrations or to permit new amitrole registrations.
     The Agency may amend this standard or initiate
     further regulatory actions after it has reviewed
     the submitted data.  All data must be generated
     according to the Good Laboratory Practices specified
     in 48 FR 53946.

 8.  Some of the required data will permit the Agency
     to perform a more accurate exposure assessment and
     determine the necessity for further regulatory
     action.  Specifically, the Agency must be able to
     assess the ability of amitrole to penetrate the
     skin and the effectiveness of protective clothing.
     Due to their pivotal nature, registrants must
     initiate and submit these studies and initiate steps
     to complete the remaining data specified in the
     tables.

 9.  Food or feed uses of this pesticide will not be
     permitted to be registered.

10.  End-use product label changes are required.

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D.  REGULATORY RATIONALE

Data indicate that amitrole has oncogenic potential.  At this
time, the Agency has determined that it will not reregister
existing use patterns of amitrole for the following reasons:

    1.  Amitrole demonstrated oncogenic potential (thyroid
        and liver tumors) in laboratory rodent feeding
        studies.  Risks associated with dietary exposure
        have been eliminated through cancellation of all
        food uses in 1971. No further food or feed uses
        will be permitted.  Risks associated with mixer/
        loader/applicator exposure remain.

    2.  Toxicological data are insufficient to fully evaluate
        the hazards associated with dermal and inhalation
        exposure to this chemical.

    3.  Monitoring of workers applying amitrole showed no
        apparent changes in thyroid function.  While the
        sole study on amitrole exposure did not adequately
        consider the effects of single or multiple episodic
        exposures on thyroid hormones, it did provide some
        evidence that brief exposures cause relatively
        minor or no effects on human endocrine systems.

    4.  The use of protective clothing specified in this
        standard and the restriction of high risk use
        patterns and application techniques of amitrole may
        reduce exposure.  While it has no adequate data on
        the ability of amitrole to penetrate the skin, the
        Agency's evaluation of its structure and solubility
        indicates that some amitrole may penetrate the
        skin.  Assuming 100 percent absorption and the
        results of the sole exposure study, workers
        associated with certain use patterns and application
        techniques are theoretically exposed to doses of
        amitrole approaching those which cause thyroid
        tumors in laboratory animals.  It is estimated
        that protective clothing may reduce worker exposure
        approximately 80 percent or more, based on the
        structure and solubility of this chemical.  This
        exposure reduction is anticipated to significantly
        reduce risk during the period of pivotal data
        development and permit continued registration under
        restricted use.

    5.  Given the scientific uncertainties associated with
        its preliminary analysis, the Agency will consult
        with experts in endocrinology and review the results
        of the pivotal data prior to deciding on how to
        further regulate this chemical.  The Agency estimates
        that the risks associated with the use of this
        chemical for one year (i.e., the time required for
        instituting the changes required by this Standard)
        are low.

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    6.  There are no data to estimate re-entry exposure to
        individuals entering areas treated with amitrole.
        Tne Agency will assess a need for a re-entry interval
        after it Has reviewed the environmental and
        toxicological data required by this standard.

    7.  Available data are insufficient to fully assess the
        environmental fate of this chemical.  A complete
        environmental fate assessment, including a review
        of the leaching potential of amitrole, will be
        performed after the required data is submitted to
        the Agency.

    8.  There are insufficient data to characterize the
        toxic effects of the end-use products of amitrole
        to aquatic organisms.  A complete hazard assessment
        will be performed after additional ecological
        effects data are submitted to the Agency.

    9.  Available data on both human and wildlife poisoning
        incidents indicate that the majority of cases of
        human poisoning cited in the Pesticide Incident
        Monitoring System (PIMS) through June, 1981 appear
        to be the result of misuse or accident. The PIMS
        data provide no information on chronic health effects
        from exposure to amitrole.

E.  CRITERIA FOR REGISTRATION UNDER THIS STANDARD

All products which contain amitrole are subject to this
standard.   The Agency will not consider registration of new
products or reregistration of current products containing
amitrole until it has reviewed the pivotal data required by
this standard.

Should the Agency decide to register and reregister amitrole
products after reviewing the pivotal data, registrants of
products containing amitrole as the sole active ingredient
must either comply with the acute toxicity limits, product
composition, and use pattern requirements listed in Section
F of this document; or submit data and a justification to
amend the standard to encompass such products.

Should the Agency decide to register and reregister amitrole
products after reviewing the pivotal data, applicants for
registration and reregistration of products which contain
amitrole as the sole active ingredient must comply with all
terms and conditions described by this standard, including
commiting to fill data gaps on a schedule agreed to by both
this agency and the applicant, and when applicable, offer-
ing to pay compensation for data to the extent required by
§ 3(c)(l)(D) FIFRA.  Applicants for registration under this
standard must follow the instructions contained in this
standard and complete and submit the appropriate forms
within the time specified.

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F.  ACCEPTABLE RANGES AND LIMITS

    1.  Product Composition Standard

Technical grade products must contain at least 90 percent
amitrole as the sole active ingredient.  Each manufacturing-
use product formulation proposed for registration must be
fully described with an appropriate certification of limits.
In addition, the manufacturing-use amitrole products must be
substantially similar to currently registered technical
products.  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

Technical grade and manufacturing-use products containing
amitrole in acute toxicity category I, II, III, or IV must
bear appropriate precautionary labeling.

    3.  Use Patterns

Manufacturing-use products containing amitrole must be
labeled for formulation only into end-use products for use
as herbicides to control grasses and broadleaf weeds in
rights-of-way, marshes and drainage ditches, ornamentals,
and around commercial, industrial, agricultural, domestic,
and recreational premises.  The attached index lists all
registered uses for end-use products, which may be formulated
from the manufacturing-use products covered by this standard,
as well as approved maximum application rates and frequency.

Formulations may be applied by using helicopter or ground
equipment, with the specific type of equipment determined
by the conditions of the site and equipment availability.

The Agency classifies all uses patterns and application
techniques, except homeowner uses, as restricted.

G.  REQUIRED LABELING

Registrants must complete all label requirements within 90
days from the receipt of this guidance document.  Products
to be released for shipment or advertized, products which
have been amended to remove any restricted uses, existing
stocks of products covered by this document, related
brochures, technical pamphlets and similar materials must
be labeled to comply with all label requirements within 90
days after the receipt of this guidance document.

All technical grade, manufacturing-use, and end-use products
containing amitrole must bear appropriate labeling as
specified in 40 CFR 162.10.  The following labeling
requirements apply to technical, manufacturing-use, and
end-use products.

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     1.  Manufacturing-Use Product Statements

         a.  Use Patterns

Products intended for formulation into end-use products must
bear the following statement:

   "For formulation only into end-use herbicide products
    intended for noncropland, outdoor use."

   "The use of this product may be hazardous to your health.
    This product contains amitrole, which has been determined
    to cause cancer in laboratory animals.  Products intended
    for formulation into restricted-use pesticides must
  -  require on its labeling that a respirator be worn during
    mixing and loading.  Lightweight waterproof clothing
    (jumpsuit [or coverall], boots [or shoes], gloves, and
    a wide-brimmed plastic hardhat) must be worn when mixing
    and loading all products and when applying all products
    to control dense, tall vegetation.  Workers applying
    this product in all other situations must wear lightweight
    waterproof gloves and boots (or shoes).  Products
    intended for formulation into general-use pesticides
    must require on its labeling that waterproof gloves be
    worn while handling the product."

All products must bear the following statements:

   "Each formulator is responsible for obtaining EPA
    registrations for its formulated product(s)."

         b.  General Warning

   "Do not discharge into lakes, streams, ponds, or public
    waters unless in accordance with NPDS permit.  For
    guidance, contact your Regional Office of the EPA."

     2.  End-Use Product Statements

         a.  General Warnings and Limitations

All restricted-use products must bear the following statements:

   "Restricted Use Pesticide"

   "For retail sale to and application only by certified
    applicators or personnel under their direct supervision."

   "The use of this product may be hazardous to your health.
    This product contains amitrole, which has been determined
    to cause cancer in laboratory animals.  Wear a respirator
    during mixing and loading of all products.  Wear
    lightweight waterproof clothing (jumpsuit [or coverall],
    boots  [or shoes], gloves, and a wide-brimmed plastic
    hardhat) when applying all products to control dense,
                             10

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    tall vegetation.  Workers applying this product in all
    otner situations must wear lightweight waterproof gloves
    and boots  (or shoes)."

All homeowner  products must bear the following statements:

   "The use of this product may be hazardous to your health.
    This product contains amitrole, which has been determined
    to cause cancer in laboratory animals.  Wear waterproof
    gloves when using this product."

All products must bear the following statements, regardless
of classification:

   "Do not allow spray or spray drift to contaminate edible
    crops or water intended for irrigation, drinking or
    other domestic purposes."

   "Do not allow livestock to graze or feed in treated non-
    crop areas."

All products intended for nonaquatic uses must bear the
following statement on the label:

   "Do not apply directly to water or wetlands.  Do not
    contaminate water by cleaning of equipment or disposal
    of wastes."

All products intended for aquatic uses must bear the following
statement on the label:

   "Consult your state Fish and Game Agency before applying
    this product to public waters.  Permits may be required
    before treating such waters."

H.  TOLERANCE  REASSESSMENT

There are no established tolerances for amitrole in the
U.S.A., Canada, and Mexico.  There are no food or feed uses .
in the U.S.A.  and residues are not permitted on any food,
feed or water  intended for irrigation, drinking, or other
domestic purposes, and to date, no new registrations or
establishment  of tolerances for amitrole have been requested.

I. PRELIMINARY ANALYSIS OF CURRENT BENEFITS AND RISKS

  1. Current Benefits Review

     a. Introduction

The Agency has completed a current benefits review for
amitrole.  The review was based on published pesticide data
and preliminary telephone discussions with users and
applicators.
                             11

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     b. Usage Site of Study

This review summarized the data available on the pesticide
applications on highway rights-of-way.  This site was
selected for analysis because it is the site on which the
greatest volume of amitrole (approximately 50 percent of
the annual production) is used and for which data are
available.  Lesser amounts of the herbicide are also used
on utility-commercial-industrial-institutional sites with
small amounts also used in forestry, aquatic areas and the
home.  Finally, the effectiveness of amitrole on poison ivy
is viewed as particularly important by individuals sensitive
to the toxic effects of this plant.  However, the total
volume used on poison ivy is small.

Amitrole is imported and is not produced in the United
States.  Currently 500,000 to 800,000 pounds of Active
Ingredient (A.I.) are imported annually.  The market for
amitrole has shown little annual fluctuation during the
last ten years.  The three major importers are Union Carbide,
American Cyanamid and Aceto Chemical.  Amitrole use
represents about 5 percent of the total herbicide used for
vegetation control on highway rights-of-way.  It is used
by a large number of state and local agencies on an estimated
100,000 acres at a rate of 2.5 to 4 pounds per acre.  Eleven
states, particularly in the west, account for most of its
use.

     c. Benefits

Vegetation control on highway rights-of-way is needed in
order to assure (1) safe shoulders for emergency exit from
the roadway (i.e.  grass must be long enough to protect the
bank from erosion but short enough so as not to obscure
obstructions), (2) adequate visibility at intersections;
(3) that the roadway is unobstructed by brush or, where
snow melting is important, the tree canopy does not overshade
the road, and (4) weed-free appearance of ornamental plants.
The major role of amitrole is to give non-selective contact
weed control, either alone or in combination with longer-
lasting herbicides, on those parts of shoulders where no
vegetation is desired (e.g.  immediately adjacent to the
pavement, or under rails and around sign posts, where
mow ing is difficult).

Benefits from the use of amitrole are associated with its
relatively low cost, broad-spectrum control of growing
plants and the ability to mix it with other low cost,
broad-spectrum residual soil active chemicals.  In combination
with other chemicals, low cost broadspectrum control is
obtained both on newly emerged or established broadleafs by
amitrole as well as seasonal control by residual product(s)
with which it is mixed.
                              12

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     d. Substitutes

Amitrole substitutes are divided into two classes: herbicidal
chemical control and non-herbicidal mechanical control.

        1) Herbicidal Control

A limited number of nonselective, broad-spectrum postemergent
substitutes are available for amitrole. These substitutes
may be divided into contact herbicides and residual soil-
active herbicides.  The amine salts of dicamba, 2,4-D, MCPP
and glyphosate are substitutes in the first category of
contact herbicides.  Glyphosate is as effective as amitrole
in the control of emerged weeds and has little residual
action, is more costly and more corrosive than amitrole and
may lose some of its activity when tank-mixed with residual
herbicides.  The amine salts of dicamba, 2,4-D, and MCPP,
while relatively inexpensive, can volatilize in hot weather
and damage sensitive crops and shoulder plants.  Additionally,
dicamba can move through soils and damage woody vegetation.

Residual soil-active herbicides offer an advantage of longer
control and lower cost than amitrole. In order to offer
season-long control, these chemicals must be applied early
in the season at high rates, a situation which could result
in off-target movement of the pesticide, vegetation removal
and soil erosion.  Additional substitutes may be used, but
not necessarily at lower cost, equal convenience or equal
effectiveness.

        2) Non-Herbicidal Control

Controlling brush on highway rights-of-way without herbicides
by manual or mechanical cutting and controlled burning are
high cost alternatives. Non-chemically controlled sites
along guardrails and steep slopes are particularly high
cost and are precisely the areas where amitrole is used.

     e. Current Review of the Economic Impacts of
        Cancellation on Highway Rights-of-Way

The Agency has estimated that the financial impact of with-
drawing amitrole could account for about a 1 to 3 million
dollar cost increase to users.  This estimate is based on
users continuing to use a contact herbicide (specifically
substituting glyphosate for amitrole) in combination with
a residual herbicide.

The Agency's preliminary estimate does not take into account
that some users may elect not to shift to another contact
herbicide but rely entirely on residual herbicides. The
Agency's preliminary information does not permit an estimate
of the extent that users would elect another contact herbicide
in place of amitrole as opposed to relying solely on the
                              13

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use of residual pesticides for germination control.  The
Agency's current benefit review may change upon receipt of
new information.

  2. Preliminary Risk Analysis

     a. Introduction

Data indicate that amitrole induces a high incidence of
thyroid tumors in laboratory animals.  Amitrole has also
been shown to induce liver tumors in mice at feeding
levels in excess of the maximum tolerated dose; thyroid
carcinomas were evident in conjunction with liver tumors.
Amitrole is a textbook example of a potent antithyroid
agent in laboratory animals.  The postulated mechanism of
action is an alteration of the complex feedback mechanism
between two endocrine glands, the thyroid and the pituitary.
Dietary administration of amitrole inhibits peroxidase
activity in the liver and thyroid, causing a subsequent
inactivation of iodide ions in the blood.  The lower level
of active iodide ion reduces the level of thyroid hormones
circulating in the blood.  The reduced level of thyroid
hormones induces the pituitary to secrete a hormone which
stimulates the thyroid.  Prolonged stimulation causes
thyroid enlargement, hyperplasia and, ultimately, tumors.

The Agency's preliminary risk analysis is based on production
data supplied by manufacturers, usage information, estimates
supplied by consumers and worker exposure estimates.  Worker
exposure estimates were obtained through surrogate studies
employing other pesticides with uses and application techniques
similar to amitrole and the only exposure study (GS009517)
which specifically used amitrole.  The Agency's assumptions
to estimate worker exposure are conservative and tend to
err in the direction of overestimating exposure.

     b. Exposure Assumptions

The following assumptions were used to estimate worker
exposure:

        1) All workers are unprotected, wearing cotton work
           clothes, short-sleeved shirt, without hat, gloves
           or respirator, with 15 percent of the body
           surface uncovered by clothing.

        2) Applicator exposure was calculated from surrogate
           data by two possible methods.  In the first and
           preferred method amitrole exposure varies as a
           linear function of the pounds of amitrole active
           ingredient expected to be used vs. the pounds of
           applied surrogate active ingredient.  When no
           data were available, applicator exposure was
           calculated as a linear function of the duration
           of application and the concentration of the
           active ingredient in the spray.

                              14

-------
        3) Mixer/loader exposures were estimated from
           surrogate data and is proportional to the amount
           of amitrole active ingredient vs. the amount of
           surrogate active ingredient.

        4) Highway tractor (or truck) applicators and forest
           helicopter applicators are tended by mixer/loader
           personnel.  Except for home-use pressurized
           aerosols, all other applicators will also be
           involved in mixing/ loading operations.

     c. Exposure Estimates

The Agency estimated the exposure for each technique of
amitrole application, with the ranges for a particular
technique based on actual field observations.  The typical
exposure is based on the average field worker exposure,
while the minimum and maximum values are the lowest and
highest exposures observed in the data.  No exposure
estimates were made for re-entry personnel.  An exposure
assessment of re-entry personnel will be made upon submission
of data requested by this standard.  The following table
summarizes the Agency's exposure estimates for mixers,
loaders and applicators.
                                15

-------
                   PRELIMINARY EXPOSURE ESTIMATES
          Exposure Situation   Minimum   Typical   Maximum
                                       (mg/kg/dy)*
        Utility
          Knapsack/Hand-Carry
            Applicator
            Mixer/Loader
          Power Wagon
            Mixer/Loader/
            Applicator
        Industry
          Knapsack/Hand-Carry
            Applicator
            Mixer/Loader
          Power Wagon
            Mixer/Loader/
            Applicator
        Railroad
          Tanktrain
            Applicator
            Mixer/Loader
          Hy-Rail
            Applicator
            Mixer/Loader
        Forest
          Knapsack/Hand-Carry
            Applicator
            Mixer/Loader
          Helecopter
            pilot
            Mixer/Loader
        Highway
          Tractor/Truck
            Applicator
            Mixer/Loader
        Home
          Aerosol Can
            Applicator	
7xlO-3
2x10-3
3x10-2


5x10-3
5x10-4
          4x10-2
          9xlO-3
          3xlO-2
          3xlO-2
9x10-2
2x10-2
8x10-1


7x10-2
3xlO-2    3X10-1
4xlO~5
8x10-3

4xlO-6
IxlO-4
          2x10-4
          4x10-2

          2xlO-5
          4x10-3
5x10-4
9x10-2

5x10-5
2x10-4
2x10-3
2xlO~5
5xlO-3
          7x10-3

          3xlO~4
          7x10-2
          IxlO-4
          3xlO-2
5xlO-3
3xlO-2

4xlO~4
3x10-4
6x10-2
3xlO~7    1x10-5    2x10-5
        *mg/kg/dy (Human Equivalents) =(
        Lifetime Exposure =(mg/dy)(dys/y
         dose/20)/3
         r)/(70kg)(2)(365)
In summary, the Agency has made a preliminary estimate that
dermal exposure, especially from the hands, constitutes
virtually all of the total amitrole exposure.  The use of
lightweight waterproof clothing (jumpsuit, gloves, hat and
boots [or shoes]) is expected to reduce dermal exposure.
Despite the minor contribution toward the total exposure, a
respirator is required during mixing/loading operations
until the effects of inhalation exposure can be better defined.

      d. Risk Estimates

The Agency cannot, with the available data, accurately predict
the risks involved with the use of amitrole.  Quantitative
risk assessments are normally based upon assumptions and,
                                  16

-------
consequently, contain uncertainties.  The amitrole risk
assessment contains more uncertainty than usually encountered
because of the lack of information about dermal absorption.
The choice of the most significant assumptions used to calculate
the risks associated with the use of this chemical are
explained in the discussion below which highlights the
principal areas of scientific uncertainty that preclude the
development of a more definitive estimate of risk.

         1) Dermal Penetration

Exposure to applicators or spray workers is the major source
of exposure as there are no food uses and other incidental
contact with this chemical would be minimal.  Data indicate
that exposure to applicators is almost entirely by the dermal
route.  Therefore, dermal penetration is a very important
parameter to estimate worker exposure.  No data are currently
available to estimate the extent of dermal penetration.  In
the absence of data, the Agency assumes 100 percent dermal
penetration, a worst case scenerio.  Realistically, the Agency
feels that much less than 100 percent dermal penetration,
based on the structure and solubility of this chemical.

The effect of dermal penetration on the risk associated with
the use of this chemical is demonstrated by the two estimates
of dermal penetration, 0.1 percent and 100 percent.  These
two estimates of dermal penetration represent a worst case
absorption and the lowest value which can be usually be
demonstrated.

         2) Risk Assessment Model

The Agency has utilized both the linear one-hit model and the
log-probit model to estimate cancer risk associated with
worker exposure to amitrole.  Estimates by both models are
presented in the risk estimate tables. 'The Agency believes
that the log probit model is most appropriate to express the
risk based on the data showing induction of thyroid tumors
and estimates realistic limits of risk, while the one-hit
model provides an upper limit of risk estimation.

Both models demonstrate similar risk estimates at high dose
levels, primarily because the estimated human exposure levels
approach the level of dosing in animal studies.  This
convergence of exposure precludes the necessity for extensive
extrapolation at high levels of exposure.  The risk estimates
diverge radically, though, at medium and low dose levels.

         3) Thyroid Extrapolation

The extrapolation of oncogenic animal data to humans is an
area of uncertainty.  Although the Agency has usually
approached extrapolation by adjusting equivalence of exposure
based on surface areas between animals and humans, the amitrole
risk assessment contains additional uncertainties because of
interpretation of data on thyroid effects.  It is not known

                                  17

-------
whether a direct comparision can be made between rat and
human thyroids or whether a correction factor should be used.
Regardless of this latter uncertainty, the Agency believes
that the human thyroid can probably withstand a greater insult
than the rat thyroid.  It is the Agency's policy to presume
that effects demonstrated in laboratory animals have the
potential to occur in humans.  This issue will be carefully
studied during the course of the Special Review for this
chemical.

         4) Basis of Risk Estimates

The Agency utilized a study by Johnson et al. (1981)
(GS009504) in its risk estimates because the dietary dosing
schedule was the most representative of the "pulsed" exposures
that are experienced by applicators and the histological
evaluation demonstrated a clear dose-response relationship.
Additionally, this study dosed rats with amitrole at levels
comparable to the highest human exposure estimates.

Dermal absorption was assumed to be 100 percent because no
acceptable dermal absorption data on amitrole are available.
A worker was assumed to weigh 70 kg, have a work exposure of
35 years over a 70 year lifetime, and wear no specialized
protective clothing during mixing/loading/application.

The positive steady dosing oncogenicity studies were not
used for the quantitative risk assessment because that dosing
pattern was less appropriate to the intermittant pattern of
applicator exposure than the pulsed study.  These studies
also utilized dosing at levels that are somewhat higher than
the lifetime average doses administered in the pulsed study.
An assessment utilizing the linear model and a steady dose
would produce risk estimates no higher than those based on
the pulsed study.  The risk assessment estimates that the
liver oncogenic risk is less than the thyroid oncogenic risk,
based on the linear model.  Thus, estimates based on the
linear model are a clear upper limit of worker risk.

Tne following tables, for comparison, demonstrate worker
risk utilizing the linear and log-probit models both applied
to the data showing induction of thyroid tumors.  Dermal
absorption estimates of 100 percent and 0.1 percent,
respectively, are used in the following tables.
                             18

-------
          PRELIMINARY RISK ESTIMATE RANGES
             (100 % Dermal Absorption)
  Exposure Situation    	Model Type	
	Log-Probit	One-Hit
Utility
  Knapsack/Hand-Carry
    Applicator          <10~8-10-3    10-2->10~l
    Mixer/Loader           <10~8      10-3-10-2
  Power Wagon
    Mixer/Loader/
    Applicator          10-8->lQ-l    10-2->lO-l
industry
  Knapsack/Hand-Carry
    Applicator          <10~8-10-4    10-2->lO~l
    Mixer/Loader        <10-8->10~1   10-3->10-l
  Power Wagon
    Mixer/Loader/
    Applicator          <10-8->lO-l   10~2->10-1
Railroad
  Tanktrain
    Applicator             <10~8      10-4-10-3
    Mixer/Loader        <10~8-10~3    10-2-10-1   10-3->10-1
    way
  Tractor/Truck
    Applicator             <10~8      10-5-1Q-3
    Mixer/Loader        <10-8_io-5    iQ-2-10-1
Home
  Aerosol Can
    Applicator	
-------
                PRELIMINARY RISK ESTIMATE RANGES
                   (0.1 % Dermal Absorption)
        Exposure Situation
                              Log-Probit
Model Type
         One-Hit
Utility
Knapsack/Hand-Carry
Applicator
Mixer/Loader
Power Wagon
Mixer/Loader/
Appl icator
Industry
Knap sack /Hand-Carry
Applicator
Mixer/Loader
Power Wagon
Mixer/Loader/
Appl icator
Railroad
Tanktrain
Applicator
Mixer/Loader
Hy-Rail
Applicator
Mixer/Loader
Forest
Knap sack /Hand-Carry
Applicator
Mixer/Loader
Helecopter
Pilot
Mixer/Loader
Highway
Tractor/Truck
Appl icator
Mixer/Loader
Home
Aerosol Can
Applicator


<10-8
<10-8


<10-8


<10-8
<10-8


<10-8


<10-8
<10-8

<10-8
<10~8


<10-8
<10-8

<10-8
<10-8


<10-8
<10~8


<10-8


10-5-1Q-4
10-6-10-5


10-4-10-3


10-5-1Q-4
10-6-10-4


10-4-10-3


10-7-10-6
10-5-10-4

10-8-10-7
10-7-10-5


10-6-10-5
10-7-10-4

10-7-10-6
10-6-10-3


10-8-10-6
10-5-10-4


10-9-10-8
        Ranges indicate minimum and maximum exposures

There is wide variation in risk estimation.  These variations
depend on the model used to estimate risk and the percent
of dermal absorption used in the exposure estimates.  The
Agency has made a preliminary estimate that a high risk may
be associated with all uses, except for the homeowner use.
Homeowner risk is estimated to be low because exposure is
estimated to be one hour per year and the chemical is
applied as a targeted (non-fogging) spray.

Despite the potential for high risk, the Agency believes
that restriction of all uses patterns and application
techniques (except homeowner uses) and the use of protective
clothing will reduce exposure 80 percent and reduce risk
                                20

-------
associated with the use of this chemical during the period
of pivotal data development.  The exposure associated with
the homeowner use will be reduced by the use of waterproof
gloves.

The Agency's preliminary analysis of the effects of
restricting all use patterns and application techniques,
except the homeowner use, coupled with the use of protective
clothing indicates that exposure and, hence, risk will be
reduced for all use patterns and application techniques
except the power wagon application of amicrole.

  3. Conclusions

The Agency has determined that amitrole may have exceeded
the oncogenicity risk criteria for Special Review.

The Agency has made a preliminary determination that the
costs of cancellation to be a 1 to 3 million dollar cost
increase to users, while the benefits of continued use are
to provide for the safe use of highways.  The Agency has
made a preliminary determination that the risk associated
with some uses is high.  Restriction of all uses, except
the homeowner use, and labeling will mitigate risk during
the period of pivotal data development and Special Review.
The Agency considers the establishment of the dermal
absorption of amitrole and the effectiveness of protective
clothing to be pivotal in its future risk assessment.

Pending further review, registration of new products and
reregistration of current products containing amitrole
cannot be permitted until the Agency has reviewed these
pivotal data.
                                21

-------
                                                        TABLE A
                                       GENERIC DATA REQUIREMENTS FOR AMITROLE
Data Requirement
§158.120 Product Chemistry
Product Identity
61-2 - Statement of Composition
61-3 - Discussion of Formation of
Unintentional Ingredients
Analysis and Certification of Product
62-1 - Preliminary Analysis
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-7 - Density, Bulk Density, or
Specific Gravity
V
Composition
TGAI
TGAI
Ingredients
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA Have Data
To Satisfy This
Requirement? ( Yes ,
No or Partially)
I/
Partially
No
No
Yes
Yes
Yes
Yes
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?When?
00052653 00052652 Yes/6 months
Yes/6 months
Yes/6 months
00052652 No
00052652 No
GS009514 No
00052652 No
Yes/6 months
V Composition:  TGAI = technical grade of the active ingredient;  PAI  = pure active ingredient.
2/ Details of the  laboratory synthesis procedures are given.  However, details of the actual manufacturing procedures
   presently being used needs to be supplied by all registrants.

                                                          22

-------
                                                       TABLED
                                        GENERIC DATA REQUIREMENTS FDR AMITRDLE
Data Requirement
Composition"
         Does EPA Have Data
         To Satisfy This
I/       Requirement?  (Yes,
   	No or Partially)
Bibliographic
  Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?When?
§158.120  Product Chemistry (cont'd)

63- 8 - Solubility                      TCAI OR PAI
63- 9 - Vapor Pressure

63-10 - Dissociation Constant

63-11 - Octanol/water partition
        coefficient

63-12 - pH

63-13 - Stability

Other Requirements

64- 1 - Submittal of samples
    PAI

    PAI

    PAI


    1GAI

    TGAI




   Choice
               Partially




               No

               No

               No


               Yes

               Yes




               No
                                   2/
                                             00052652
                                             00033124
                                             00069171
  00052652

  00052652
      Yes/6  months



      Yes/6  montfts

      Yes/6  months

      Yes/6  months


       No

       No



       Yes/6 months
\/ Composition:  TGAI = Technical grade of the active  ingredient; PAI
   several test substances determined on a case-by-case basis.
2/ Solubilities in quantitative terms are needed.

                                                          23
                              =  Pure active  ingredient;  Choice = Choice of

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

DEGRADATION STUDIES-LAB;

161-1 - Hydrolysis

PHOTODEGRADATION;

161-2 - In water

161-3 - On soil

METABOLISM STUDIES-LAB;

162-1 - Aerobic Soil


162-3 - Anaerobic Aquatic

162-4 - Aerobic Aquatic
TGAI or PAIRA   B,D,G,H




TGAI or PAIRA   B,D,G

TGAI or PAIRA   G




TGAI or PAIRA   B,G,H



TGAI or PAIRA   D,G

TGAI or PAIRA   D
                        No




                        No

                        No




                        Partially"


                        No

                        No
3/
     00036962
     00027115
00033127
00089104
Yes/6 months



Yes/6 months

Yes/6 months



Yes/24 months


Yes/24 months

Yes/24 months
V 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=Terrestrial,  Food Crop;  B=Terres trial, Non-Food; C=Aquatic,  Food Crop;
   D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor;  I=Indoor.
3/ Studies 00036962, 00033127, 00089104 , and 00027115, partially satisfy the aerobic soil metabolism data require-
   ments by providing data on the rate of degradation of amitrole in several soil types.  No data were provided on the
   formation and decline of degradation products of amitrole in aerobic soil other than ^cx  (00027115).
                                                          24

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                                                        TABLED
                                        GENERIC DATA REQUIREMENTS  FOR AMITROLE
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)?Wnen?
§158.130 Environmental Fate (cont'd)

MOBILITY STUDIES;

163-1 - Leaching and           TGAI or PAIRA   B,D,G,H
         Adsorption/Desorption
                                   Partially
                                            3/
                       00032045  00044017
                        Yes/6 months
DISSIPATION STUDIES-FIELD:
164-1
164-2
164-3
164-5
- Soil
- Aquatic (Sediment)
- Forestry
- Soil, Long-term
TEP
TEP
TEP
TEP
B,G,H
D
G
B,D,G,H
No
No
No
No
Yes/24 months
Yes/24 months
Yes/24 months
I/
Reserved
   Composition:  TGAI = Technical grade of the active ingredient;  PAIRA = Pure active  ingredient, radio-labelled;
   TEP = Typical end-use product.
2/ The use patterns are coded as follows:   A=Terrestrial,  Food Crop; B=Terrestrial, Non-Food;  C=Aquatic, Food Crop;
   D=Aqautic, Non-Food; E=Greenhouse, Food Crop;  F=<3reenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3_/ These soil thin layer chromatography studies fulfill the rapid  leaching part of the mobility data requirement for the
   noncrop use patterns by providing information on the movement (Rf values) of amitrole  on sand, sandy loam, silt loam,
   clay loam, and silty clay loam thin layer plates.  To totally satisfy the mobility  data requirements the following
   studies are required.  1) A mobility study to assess the leaching potential of amitrole and its degradates after the
   pesticide has been aged in sandy loam soil or a soil representative of the use area.   This will satisfy the data
   requirement for noncrop use patterns.  2)A batch equilibrium  (adsorption/desorption) study on a sandy soil or a soil
   representative of the domestic use area.  This will satisfy the data requirement for the domestic outdoor use pattern.
   3) A batch equilibrium (adsorption/desorption) study on one aquatic sediment obtained  from a representative aquatic
   use area.  This will satisfy the data requirement for the aquatic noncrop use pattern.  4)  A soil thin layer chromato-
   graphy, soil column, or a batch equilibrium (adsorption/desorption) study on a soil representative of the use area
   (forest).  This will satisfy the data requirement for the forestry use pattern.
4/ The requirement for Dissipation: Long Term Studies is reserved  depending upon the results of the Field Dissipation Study
                                                           25

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                                                       TABLE A
                                       GENERIC DATA REQUIREMENTS FDR AMITROLE
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)?When?
§158.130 Environmental Fate (cont'd)
ACCUMULATION STUDIES;

165-3 - Irrigated Crops

165-4 - In Fish

165-5 - In Aquatic Non-Target
         Organisms

SPECIAL EXPOSURE STUDIES:

      - Protective Clothing
        Effectiveness

      - Exposure Study	
    TEP

TGAI or PAIRA



    TEP




    TEP



    TEP
D

B,DrG



D,G




B,D,G



B,D,G
    No

    Yes


    No




    No


Partially
00061349
GS009517
        4/
Yes/24 months

No


NcT



Yes/6 months


No
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=Terrestrial, Food Crop; B=Terrestrial,  Non-Food;  C=Aquatic, Food Crop;
   D=Aqautic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3_/ Accumulation studies in aquatic non-target organisms are required to support aquatic non-food and forestry
   use patterns.  However, the accumulation studies for non-target organisms are waived because the data from the
   laboratory fish accumulation study did not show a potential for residues of amitrole to accumulate in bluegills.
V This study only evaluated worker exposure.  A study to evaluate the effectiveness of the protective clothing is
   required. The Agency should be contacted for protocol review.
                                                          26

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                                                       TABLED
                                       GENERIC DATA REQUIREMENTS FOR AMITROLE
Data Requirement
                               Composition"
  Use   2/
Patterns
            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)?When?
§158.135 Toxicology

ACUTE TESTING

                 - Rat
81-1 - Oral

81-2 - Dermal LD50

81-3 - Inhalation LC50 - Rat

81-4 - Primary Eye Irritation

81-5 - Primary Skin Irritation

81-6 - Dermal Sensitization

81-7 - Acute Delayed
       Neurotoxicity - Hen

SUBCHRONIC TESTING

82-1 - 90-Day Feeding -
        Rodent only



82-3 - 90-Day Dermal _
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
B,D,G,H
B,D,G,H
B,D,H
B,D,G,H
B,D,G,H
B,D,G,H
B,D,G,H
                                  TGAI
                                   TGAI
B,D,G,H
B,D,G,H
                  Yes

                  Yes

                  Yes

                  Partial

                  No

                  No

                  No
Yes
Partially
                 00063598

                 00063599

                 GS009502

                 000063599"
                                                                                        5/
00052658 00082174
00052643 00063601
00028434 00063598

GS009517
                         No

                         No

                         No

                         Yes/6  months

                         Yes/6  months

                         Yes/6  months

                            I/
                         No
                                                             No
                                                             Yes/24 months
I/ Composition:  TGAI = Technical grade of  the active ingredient.
~2/ The use patterns are coded as follows:   A=Terrestrial, Food Crop; B=Terrestrial, Non-Food;  C=Aquatic, Food Crop;
   D=Aquaticf Non-Food; E=Greenhouse,  Food  Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ Amitrole is not structurally related to  a known neurotoxin nor does  it  inhibit cholinesterase.
T/ The study indicated that an unprotected  worker could receive dermally 20.4 mg/kg/day of  amitrole under test conditions.
   Medical monitoring of thyroid function was not assessed for a sufficient  time period. Thyroid function must be
   monitored in the required study.  Also, the ability of this chemical  to  be absorbed dermally must be quantified.
5/ The scoring system and eye irritation scores were not reported. These data must be provided or the test must be rerun.
                                                          27

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                                                       TABLE A.
                                       GENERIC DATA REQUIREMENTS  FOR AMITROLE
Data Requirement
           V   Use  2/
Composition   Pattern
Does EPA Have Data
To Satisfy This
Requ i rement?  (Yes,
No or Partially)?
Bibliographic
  Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?When?
§158.135 Toxicology (cont'd)

82-4 - 90-Day Inhalation - Rat     TGAI      B,D,G,H

CHRONIC TESTING

83-1 - Chronic Toxicity -         TGAI       B,D,G,H
        2 species:   Rodent
        and Non-rodent
83-2 - Oncogenicity Study -       TGAI       B,D,G,H
        2 species:   Rat and
        Mouse preferred
83-3 - Teratogenicity -
        2 species                TGAI        B,D,G,H

83-4 - Reproduction -
	2-generation	TGAI	B,D,G,H
                                Partially
                                Yes
                        GS009502 GS009517
                         00061351 00061348
                         00082176 GS009503
                         00061340 GS009504
                         GS009505 GS009520
                          yes/24  months
                          No
                                Yes
                         00061351
                         00082176
                         00061340
                         GS009505
                         GS009520
          00061348
          GS009503
          GS009504
          GS009518
       No
                                Partially"
                                Yes
                                         3/
                         GS009506 GS009507
                        GS009506
                           Yes/24 months
                          No
I/ Composition:   TGAI  = Technical grade of  the active  ingredient.
TT/ The use patterns are coded as follows:   A=Terrestrial, Food Crop;  B=Terrestrial,  Non-Food; C=Aquatic, Food Crop;
   D=Aquatic, Non-Food; E=Greenhouse, Food  Crop;  F=Greenhouse, Non-Food;  G=Forestry; H=domestic Outdoor; I=Indoor.
_3/ The two available studies were incomplete  in reporting and design.   The teratology study in mice (GS009506) did not
   measure the water consumption of the animals (amitrole was fed  to the  animals in the drinking water).  The study in
   rats (GS009507)  did not have visceral or skeletal examination of  the fetuses.
V Thyroid function must  be monitored in this study.
                                                          28

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                                                       TABLE A
                                        GENERIC DATA REQUIREMENTS  FDR AMITROLE
Data Requirement
Composition"
                                          V
  Use  2/
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)?When?
§158.135 Toxicology (cont'd)

MUTAGENICITY TESTING

84-2 - Gene Mutation

84-2 - Chromosomal Aberration

84-2 - Other Mechanisms of
        Mutagenicity

SPECIAL TESTING

85-1 - General Metabolism
   TGAI

   TGAI


   TGAI
B,D,G,H

B,D,G,H


B,D,G,H
      Yes
I/

V
      Yes
PAI or PAIRA  B,D,G,H
                              I/
     - Dermal Absorption Study    PAIRA
              BfD,G,H
      Yes"
                  Yes
                  No
         3/
00052661
00052660
00052665
00052662
00052646
00052648
00079923
00052647
00052649
05020819
05020822
GS009508
GS009509
                        00052659 00052645
                        00052644 GS009510
                        GS009511
No

No


No



No



Yes/6 months
V 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=Terrestrial, Non-Food; C=Aqautic,  Food Crop;
   D=Aquatic, Non-Food; E<5reenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor;  I=Indoor.
3/ The citations apply to all mutagenicity testing.
4/ Contact the Agency for specific data requirements and protocol review.
                                                           29

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

AVIAN AND MAMMALIAN TESTING

71-1 - Avian Oral LD$Q            TCAI

71-2 - Avian Dietary IC$Q         TGAI

AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish
    TGAI
     B,D,G,H

     B,D,G,H




     BfD,G,H
No

Yes




Yes
                                                          5/
72-2 - Acute IC$Q Freshwater
        Invertebrates
72-3 - Acute LCso Estuarine
        and Marine Organisms
    TEP



    TGAI




    TEP



    TGAI

    TEP
                                              D
     B,D,G,H
     D

     D
Partially

         /
Partially"



No


No

No
                                                  00022923
        6/       6/
00025435 00069192
        V       I/
GS009519 GS009515
        I/
GS009516
        I/
00024959

        6/       6/
GS009519 00017800
                                                                                 0500149
                                       Yes/24 months

                                       No



                                       No
                                       Yes/24 months


                                       Yes/24 months



                                       Yes/24 months


                                       Yes/24 months

                                       Yes/24 months
I/ Composition:  TGAI = Technical Grade of the active ingredient; TEP = Typical  end-use product.
2/ The use patterns are coded as follows:  A=*Terrestrial, Food Crop; B=Terrestrial,  Non-Crop; C=Aquatic, Food Crop;
   D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ The formulated product tested was not representative of products used to control  aquatic vegetation.
T/ The test was not performed according to the recommended procedures.  Recommended  test procedures call for testing
   the first instar stage as opposed to the mature stage of the organism.   The former are generally more sensitive
   than the latter.
5/ This study fulfills Guideline requirements and supports registration.
6/ This study does not fulfill Guideline requirements.
                                                          30

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

NONTARGET INSECT TESTING -
POLLINATORS;

141-1 - Honey bee acute
	contact LDc;o	
    TGAI
    B,D,G,H
Yes
00036935
No
I/ Composition:  TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2/ The use patterns are coded as follows:   A=Terrestrial,  Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop:
   D=Aqautic, Non-Food; E=Greenhouse, Food Crop;  F=Greenhouse,  Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
                                                           31

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                                                       TABLE B
                PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING AMITROLE
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)?When?
§158.120 Product Chemistry

Product Identity

61-1 - Identity of Ingredients

61-2 - Statement of Composition

61-3 - Discussion of Formation of
       Unitentional Ingredients
     MP

     MP


     MP
Analysis and Certification of  Product Ingredients
62-1 - Preliminary Analysis

62-2 - Certification of Limits

62-3 - Analytical Methods for
        Enforcement of Limits
     MP

     MP


     MP
     Yes

     Partially"


     No



     No

     No


     Partially"
2/
00052653  00052652

00052653  00052652
3/
            00063956
No

Yes/6 months


Yes/6 months



Yes/6 months

Yes/6 months


Yes/6 months
Physical and Chemical Characteristics
63-2
63-3
63-4
63-7
- Color
- Physical State
- Odor
- Density, bulk density, or
specific gravity
MP
MP
MP
MP
Yes
Yes
Yes
No
00052652
00052652
GS009514

No
No
No
Yes/6 months
I/  Composition:   MP = Manufacturing-use product.
"2/  Details of the laboratory synthesis procedure are given.  However,  details of the actual manufacturing
    presently being used have not been supplied by any of the registrants.
3_/  Descriptions and validation  data for analytical methods used must be submitted by each registrant.
                                                                        procedures
                                                          32

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                                                       TABLED
                PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING AMITPOLE

                                                        Does EPA Have Data                          Must Additional
                                                        To Satisfy This                             Data Be Submitted
                                              V        Requirement?  (Yes,       Bibliographic     Under FIFRA Section
Data Requirement	Composition	No or Partially)	Citation	3(c)(2)(B)?When?

§158.120 Product Chemistry (cont'd)

63-12 - pH                             MP                     No                                         Yes/6  months

63-14 - Oxidizing or reducing

63-15
63-16
63-17
action
- Flammability
- Explodability
- Storage Stability
MP
MP
MP
MP
No
No
No
No
Yes/6 months
Yes/6 months
Yes/6 months
Yes/6 months
V Composition:  MP = Manufacturing-use product; Choice = Test substance choice determined on a case-by-case  basis.

                                                          33

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                                                       TABLE B
                PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING AMITROLE
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)?2/When?
§158.135 Toxicology

ACUTE TESTING

81-1 - Oral LDso - Rat

81-2 - Dermal 11)50

81-3 - Inhalation ££50  - Rat

81-4 - Primary Eye
        Irritation -  Rabbit

81-5 - Primary Dermal
        Irritation

81-6 - Dermal Sensitization
MP

MP

MP



MP



MP

MP
      Yes

      Yes

      Yes


      Partially"


      No

      No
4/
00063598

00063599

GS009502


00063599
                                     No
   I/
   3
   3/
                                     No
   I/
 No


Yes/6 months


Yes/6 months

Yes/6 months
I/ Composition:   MP = Manufacturing-use product.
2/ Data must be submitted within 8 months.
3/ This is based on the  assumption that the manufacturing-use products are similar in composition to the technical product
   originally tested.
4/ The scoring system was not reported.  Either the scoring system and scores should be forwarded or the test should be
   redone unless the pH  is  less than 2 or greater than 11.5; and the product will be classified Toxicity Category I  on
   the basis of potential eye and dermal irritation effects.
                                                          34

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       II.   REQUIREMENT FOR SUBMISSION OF GENERIC DATA
    A.  This portion of the guidance document is a Notice
        issued under the authority of FIFRA Section 3(c)(2)(B)
        and describes, in table format, the data required
        for maintaining the registrability of each product.
        Additionally, a bibliography (Appendix I) 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 V 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 submitted2/.  Any
        necessary studies must be conducted in accordance with
        acceptable protocols, examples of which are contained
        in EPA's Pesticide Assessment Guidelines-^/, and, for the
        most part, in 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.
    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/ U.S. EPA, 1982.  Pesticide Registration; Proposed Data
Requirements - Part 158.  FEDERAL REGISTER of November 24, 1982
(47 FR 53192).

    _3/ U.S. EPA, 1983.  Pesticide Assessment Guidelines, National
Technical Information Service, Springfield, VA.

                               35

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        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
        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
    II] 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 III)*/

    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.)
     V FIFRA Section 3(c)(2)(B) authorizes joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
(Footnote continued at bottom of next page)

                                36

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    5.  Request voluntary cancellation of the registration(s)
        of your products for which the data are needed.

    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 will consider your request, you remain subject to the
        deadlines for submitting the required data until EPA
        grants your request.
(Footnote continued from previous page)
to jointly develop data but fail to agree on all the terms of
the agreement.  The statute does not compel any registrant to
agree to develop data jointly.
     In EPA's opinion, joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public interest.  Duplication of testing could
increase costs, tie up testing facilities, and subject an unneces-
sarily large number of animals to testing.
      As noted earlier, EPA has discretion 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)(iii)]; and (3) the first registrant has declined
to agree to enter into a cost-sharing agreement, EPA will not
suspend the second firm's registration.  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.

                             37

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   III.  REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA

     Note:  This chapter 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 IV) 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 §3(c)(2)(B)."
                          38

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   IV.  SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION


    Note:  This chapter applies only to manufacturing-use products,
not end-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 §162.11(c)], pack-
aging [40 CFR §162.16], and labeling [40 CFR §162.10, Appendix
V-l an V-2],  as indicated by the following paragraphs of this
chapter of the guidance document.

    You must submit the revised labeling set forth in this guidance
package within 90 days of receipt of this guidance package.

    A.  Label Contents

        40 CFR §162.10 (Appendix V-l) 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 Tables D, E,
    and F (Appendix V-2).

        Item 1.  PRODUCT NAME - The name, brand, or trademark is
    required to be located on the front panel, preferably centered
    in the upper part of the panel.  The name of a product will
    not be accepted if it is false or misleading.  See Appendix
    V-2.  [40 CFR §162.10(b)]

        Item 2.  COMPANY NAME, ADDRESS AND PHONE NUMBER - The name,
    address and phone number 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 V-2.   [40 CFR §162.10(c)]

        Item 3.  AVERAGE NET CONTENTS - An average 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 average
    net contents must be stated in terms of weight, expressed as
    avoirdupois pounds and ounces, and stated in terms of the
                             39

-------
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
V-2.  [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 V-2.
[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 V-2.  [40 CFR §162.10(f)]

    Item 6.  INGREDIENT STATEMENT - An ingredient statement
is required on the front panel and must contain the name and
nominal percentage by weight of each active ingredient and
the total percentage by weight of all inert ingredients as
indicated in your certification of limits.  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 V-2.  [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.
                          40

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Size of Label
on Front Panel
in Square Inches

5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word as Re-
quired Minimum Type
Size All Capitals

      6 point
     10 point
     12 point
     14 point
     18 point
"Keep Out of Reach
    of Children"
  	as Required	

     6 point
     6 point
     8 point
    10 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 V-2.  [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 V-2.
[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 V-2.  [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 V-2.  [40 CFR §162.10(h)(1)(iii)]

    Item 7E.  REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See Appendix V-2.  [40 CFR §162.10(h)(1)(iii)]

    Item 8.  SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline.  Each
of the three hazard warning statements must be headed by the
appropriate hazard title.  See Appendix V-2.  [40 CFR §162.10
                            41

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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 V-2.  [40 CFR §162.10
    Item 8B.  ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage.  See Appendix V-2.  [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 V-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 inches,  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) .
                    42

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    3.  Declaration of non-flammability.  Products which meet
        the criteria for non-FlammabilTty 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
        §163.61-10(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 V-2.  [40 CPR §162.10(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 use
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 V-4 for the latest specific
storage and disposal product label statements.

    Item 10B.  DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide.  When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.  See
Appendix V-2.  [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.

                          43

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V.    INSTRUCTIONS FOR SUBMISSION

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

    Robert Taylor (PM 25)
    Phone No. (703)-557-1800
    Registration Division (TS-767)
    Office of Pesticide Programs
    Environmental Protection Agency
    Washington, D.C.  20460

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 and revised labeling.  Refer to Appendix
        II 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 (Appendix
            III).

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

    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.

You will be informed at a later date when you must submit your
Application for Amended Pesticide Registration (EPA Form 8570-1).
                           44

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APPENDIX  I

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                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 OP 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 OP  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 explanation.  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 HRID  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 materials
    submitted to EPA, by a description of the earliest Known
    submission.  Bibliographic conventions used reflect the
    standards of the American National Standardq 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 shown
         an identifiable laboratory or testing facility as
         author.  As a  last resort, the  Agency has shown the
         first toown submitter as author.

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b.   Document Date.  When  the  date  appears as four digits  •
     with no question narks/ 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
     following elements describing  the earliest known
     submission:

     (1)  Submission Date. Immediately following the word
          •received1 appears the  date of the earliest known
          submission.

     (2)  Administrative Number.' The next element/
          immediately following the  word 'under1, is the
          registration number/ experimental permit number/
          petition number/ or  other  administrative number
          associated with  the  earliest known submissions

     (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
          tne symbol 'CDL1/ 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 123456-2; and  the 27th/ 123456-AA.

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

MRID          CITATION

GS009518      Alexander, N.M. (1959) Antithyroid Action of 3-amino-l,2,4 tria-
                 zole.  Journal of Biological Chemistry 243:148-150.

00033124      American Chemical Paint Company (1955) Weedazol: H-60.  (Unpub-
                 lished study received Jun 9, 1955 under 264-68; submitted by
                 Union Carbide Agricultural Products Co., Ambler, PA.; CDL:
                 001845-A)

00063956      American Cyanamid Company (1957) Crop Residue Data: Corn, soy-
                 beansm apples, cranberries.  (Compilation; unpublished study
                 received Mar 18, 1957 under 241-37; CDL:222312-E)

00089104      American Cyanamid Company (1959) Aminotriazole Residues in Soil.
                 (Compilation; unpublished study, including published data,
                 received May 16, 1960 under 241-37; CDL-.120214-A)

00069171      American Cyanamid Company (1961) The Name, Chemical Identity, and
                 Composition: Amino Triazole Weedkiller®: 3-amino-l,2,4-tria-
                 zole.  (Unpublished study received Nov 18, 1959 under 241-37:
                 CDL:231111-G)

00036935      Atkins, E.L.; Greywocd, E.A.; MacDonald, R.L. (1975) Toxicity of
                 Pesticides and other Agricultural Chemicals to Honey Bees.
                 Laboratory Studies.  University of California, Division of
                 Agriculture Science Leaflet 2287. 38 pp.

00052643      Babish, J.G. (1977) Triiodothyronine (T-3) and Thyroxine (T-4)
                 levels in male rats consuming amitrole (3-amino, 1-2-4-triazole)
                 in their diets for four weeks followed by a four-week recovery
                 period; laboratory No. 5539.  (Unpublished study received Sep
                 22, 1980 under 264-135; prepared by Food and Drug Research Lab-
                 oratories, Inc., submitted by Union Carbide Agricultural Products
                 Co., Ambler, PA.; CDL:243310-A)

00063601      Bagdon, R.E.; Shaffer, C.B.; Vidone, L.B. (1956) Aminotriazole:
                 Acute and Subacute Toxicity: Report No. 56-29.  (Unpublished
                 study receeived Feb 26, 1957 under 241-37; submitted by Ameri-
                 can Cyanamid Co., Princeton, N.J.; CDL:222312-J)

00052662      Bamford, D.; Sorsa, M.; Gripenberg, U.; et al. (1976) Mutagenicity
                 and Toxicity of Amitrole.  III. Microbial Tests.  Mutation Re-
                 search 40:197-202.  (Also in unpublished submission received
                 Sep 22, 1980 under 264-135; submitted by Union Carbide Agri-
                 cultural Products Co., Ambler, PA.; CDL:243309-M)

GS009517      Baugher, D.G.; Bookbinder, M.G.; Blundell, M.S. (1982) Medical
                 Monitoring and Assessment of Exposure of Workers Applying
                 Amitrole to Utility Rights-of-Way.  (Unpublished study rec-
                 eived Nov 18, 1982; prepared by Dynamac Corporation; submitted
                 by Union Carbide Agricultural Products Company, Inc., Research
                 Triangle Park, NC.)

-------
05020819      Bignami, M.; Aulicino, F.; Velcich, A.; Carere, A.; Morpurgo, G.
                 (1977) Mutagenic and Recombinogenic Action of Pesticides in
                 Aspergillus nidulans.  Mutation Research 46(6):395-402.

00069192      Bond, C.E.; Lewis, R.H.; Fryer, J.L. (1960) Ibxicity of Various
                 Herbicidal Materials to Fishes.  Pages 96-101, in Transactions
                 of the 1959 Seminar of Biological Problems in Water Pollution.
                 By Robert A. Taft Engineering Center.  Cincinnati, Ohio: U.S.
                 Public Health Service.  (Technical Report W60-3; published
                 study; CDL:230691-H)

GS009505      Bionetics Research Laboratories, Inc. (1968) Evaluation of Car-
                 cinogenic, Teratogenic, and Mutagenic Activities of Selected
                 Pesticides and Industrial Chemicals.  Vol. I: Carcinogenic
                 Study.  Report No. NCI-DCCP-CG-1973-1-1.  (Prepared by Bionetics
                 Research Laboratories, Inc., Bethesda, MD., prepared for
                 National Cancer Institute, Inc., MD., August 1968; U.S. Depart-
                 ment of Commerce, NTIS No. PB-223 159)

00052646      Brusick, D. (1975) Mutagenic Evaluation of Compound: 3-amino-l,2,4-
                 triazole: 99.4%:LBI Project 12547.  (Unpublished study received
                 Sep 22, 1980 under 264-135; prepared by Litton Bionetics, Inc.,
                 submitted by Union Carbide Agricultural Co., Ambler, PA*;
                 CDL.-243310-D)

00052649      Brusick, D. (1975) Mutagenic Evaluation of Compound: 3-amino-l,2,4-
                 triazole: Ammonium Thiocyanate: LBI Project No. 2547.  (Unpub-
                 lished study received Sep 22, 1980 under 264-135; prepared by
                 Litton Bionetics, Inc., submitted by Union Carbide Agricultural
                 Products Co., Ambler, PA.; CDL:243310-G)

00052648      Brusick, D. (1975) Mutagenic Evaluation of Compound: 3-amino-l,2,4-
                 triazole: Final Report In Vitro Cellular Transformation in BALB/
                 3T3 Cells: LBI Project No. 2549.  (Unpub lished study received
                 Sep 22, 1980 under 264-135; prepared by Litton Bionetics, Inc.,
                 submitted by Union Carbide Agricultural Products Co., Ambler,
                 PA.; CDL:243310-F)

05020822      Carere, A.; Ortali, V.; Cardanone, G.; Ibrracca, A.M.; Raschetti,
                 R.; (1978) Microbiological Mutagenicity Studies of Pesticides
                 In Vitro.  Mutation Research 57(3):277-286.

GS009502      Cox, G.E.; Re, T.A. (1978) Inhalation Toxicity Study with 3-amino-
                 1,2,4-triazole (Amitrole) in Adult Fischer 344 Rats.  Lab No.
                 5492.  (Unpublished study prepared by Food and Drug Research
                 Laboratories, Inc., submitted by Union Carbide)

00017800      Crosby, D.G.; Tucker, R.K. (1966) Toxicity of Aquatic Herbicides
                 to Daphnia magna.  Science 154(0ct 14):289-291.  (Also in un-
                 published submission received Mar 17, 1976 under 38329-2; sub-
                 mitted by Cosolidated Chemical Co., Denver, Col.; CDL:225259-K)

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GS009509
00063599
GS009510
GS009511
00063598
00052658
GS009506


00044017
00022923
00061349
GS009504
Dunkel, V.C. (1979) Collaborative Studies on the Salmonella/
   Microsome Mutagenicity Assay.  Journal Association of Analytical
   Chemistry 62(4):874-882.

Elsea, J.R. (1954) Acute Dermal Application: Acute Eye Applica-
   tion.  (Unpublished study received Feb 26, 1957 under 241-37;
   prepared by Hazelton Laboratories, submitted by American Cyan-
   amid Co., Princeton, NJ; CDL:222312-H)
Fang, S.C.; George, M.; Chang Yu,
   l,2,4-triazole-5-C14 by Rats.
   Chemistry 12(3):219-223.
T. (1964) Metabolism of 3-amino
Journal of Agricultual Food
Fang, S.C.; Khanna, S.; Rao, A.Y. (1966) Further Study on the
   Metabolism of labeled 3-amino-l,2,4-triazole (ATA) and its
   Plant Metabolites in Rats.  Journal of Agricultural Food
   Chemistry 14(3):262-265.

Fogleman, R.W. (1954) Final Report: Acute Oral Administration -
   Mice; Acute Oral Administration - Dogs; Pharmacodynamics - Dogs;
   Subacute Feeding - Rats.  (Unpublished study received Feb 26,
   1957 under 241-37; prepared by Hazelton Laboratories, submitted
   by American Cyanamid Co., Princeton, NJ; CDL:222312-G)

Fregly, M.J. (1968) Effect of Aminotriazole on Thyroid Function
   in the Rat.  Toxicology and Applied Pharmacology 13:271-286.
   (Also in unpublished submission received Sep 22, 1980 under
   264-135; submitted by Union Carbide Agricultural Products Co.,
   Ambler, PA; CDL:243309-I)

Gaines, T.B.; Kimbrough, R.D.; Linder, R.E. (1973) The Toxicity of
   Amitrole in Rats.  Toxicol. Appl. Pharmacol. 26:118-129.

Helling, C.S. (1971) Pesticide Mobility in Soils: II. Applications
   of Soil Thin-Layer Chromatography.  Soil Society of America
   Proceedings 35:737-748.  (Also in unpublished submission receiv-
   ed May 5, 1975 under 464-323; submitted by Dow Chemical U.S.A.,
   Midland, Mich.; CDL:221997-S)

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

Iwan, G.R. (1978) l^C-Amitrole, Bluegill Sunfish, Lepomis
   macrochirus, Bioaccumulation Study.  (Unpublished study received
   Sep 22, 1980 under 264-135; submitted by Union Carbide Agricult-
   ural Products Co., Ambler, PAf; CDL:243311-A)

Johnson, W.D.; Becci, P.J.; Parent, R.A. (1981) Lifetime Feeding
   Study of Amitrole in Fischer 344 Rats.  Laboratory No. 5651.
   (Unpublished study prepared by Food and Drug Research Labor-
   atories, Inc.; submitted by Union Carbide Agricultural Products
   Co., Ambler, PA)

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GS009519      Johnson, W.W.; Finley, M.T. (1980) Handbook of Acute Toxicity of
                 Chemicals to Fish and Aquatic Invertebrates.  U.S. Dept. of the
                 Interior, Fish and Wildlife Service Resources Publication No.
                 137, 98 pp.

00082176      Keller, J.G. (1959) Final Report: Two-year Chronic Feeding - Rats,
                 (Unpublished study received Dec 20, 1958 under PP0210; prepared
                 by Hazelton Laboratories, submitted by American Cyanamid Co.,
                 New York, N.Y.; CDL:090236-F)

00028434      Keller, J.G. (1960) Final Report: 28-day Dietary Feeding Study -
                 Rats.  (Unpublished study received Aug 9, 1960 under unknown
                 admin, no.; prepared by Hazelton Laboratories, Inc., submitted
                 by Union Carbide Agricultural Products Co., Ambler, PA.; CDL:
                 106983-A)

00052665      Knickerbocker, M.; Stevens, K.R. (1978) A Study to Determine the
                 Potential of Amitrole to Induce Dominant Lethal Mutations in
                 HA (ICR) Mice: Laboratory No. 5502.  (Unpublished study receiv-
                 ed Sep 22, 1980 under 264-135; prepared by Food and Drug Research
                 Laboratories, Inc., submitted by Union Carbide Agricultural Pro-
                 ducts Co., Ambler, PA; CDL:243310-H)

00052660      Laamanen, I.; Sorsa, M.; Bamford, D.; et al. (1976) Mutagenicity
                 and Toxicity of Amitrole.  I. Drosophila Tests.  Mutation Re-
                 search 40:185-190.  (Also in unpublished submission received
                 Sep 22, 1980 under 264-135; submitted by Union Carbide Agri-
                 cultural Products CO., Ambler, PA; CDL:243309-A)

00052644      MacDonald, C.M.; Pullinger, D.H. (1976) A Pharmacokinetic Study
                 to Compare Head Only and Whole Body Inhalation Methods of
                 cl^Amitrole Exposure: Project No. 291/1.  (Unpublished study
                 received Sep 22, 1980 under 264-135; prepared by Hazelton Lab-
                 oratories Europe, Ltd., submitted by Union Carbide Agricultural
                 Products Co., Ambler, PA; CDL:243310-B)

00027115      MacRae, I.C.; Alexander, M. (1965) Microbial Degradation of Selec-
                 ted Herbicides in Soil.  Journal of Agricultural and Food Chem-
                 istry 13(l);72-75.  (Also in unpublished submission received
                 Jul 19, 1978 under 201-403; submitted by Shell Chemical Co.,
                 Washington, D.C.; CDL:234475-H)

00024959      McCann, J.A. (1972) Fenavar: Toxicity to Rainbow Trout: Test No.
                 478.  (U.S. Agricultural Research Sevice, Pesticides Regulation
                 Div., Animal Biology Laboratory, unpublished report.)

GS009516      McCann, J.A. (1976) Amitrole (90%): Toxicity to Bluegill Sunfish:
                 Test No. 1060. (U.S. Environmental Protection Agency, Pesticide
                 Regulation Division, Animal Biology laboratory, unpublished
                 report.)

GS009515      McCann, J.A. (1976) Amitrole (90%): Toxicity to Rainbow Trout:
                 Test No. 1052. (U.S. Environmental Protection Agency, Pesticide
                 Regulation Division, Animal Biology Laboratory, unpublished
                 report.)

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00052661      Meretoja, T.; Gripenberg, U.;  Bamford,  D.;  et al.  (1976)  Muta-
                 genicity and Toxicity of Amitrole.   II.  Human Lymphocyte
                 Culture Tests.  Mutation Research 40:191-196.  (Also in unpub-
                 lished submission received Sep 22,  1980  under 264-135; submitted
                 by Union Carbide Agricultural Products Co., Ambler,  PA; CDL:
                 243309-L)

00052647      Prince, H.N. (1977) Ames Salmonella/Microsome Mutagen Assay:  GBL
                 7515; Laboratory No. 5634.   (Unpublished study  received Sep 22,
                 1980 under 264-135; prepared by Gibraltar Biological Laborator-
                 ies, Inc., for Food and Drug Research Laboratories,  Inc.,  sub-
                 mitted by Union Carbide Agricultural Products Co., Ambler, PA;
                 CDL:243310-E)

00079923      Rashid, K.A. (1974) Mutagenesis Induced in  Two Mutant Strains of
                 Salmonells typhimurium by Pesticides and Pesticide Degradation
                 Products.  Master's Thesis, Pennsylvania State  Univ.,  Dept. of
                 Entomology.  (Unpublished study received Feb 23,  1978  under
                 100-551; submitted by Ciba-Geigy Corp.,  Greensboro,  N.C.;  CDL:
                 232925-A)

00032045      Reichert, B.L.; Knoll, B.A. (1979) CL 217,300: Determination of
                 Mobility in Soil: Project No. 0420.   (Unpublished study rec-
                 eived Jun 11, 1980 under 241-260; submitted by  American Cyan-
                 amid Co., Princeton, N.J.;  CDL:099457-C)

05001497      Sanders, H.O. (1970) Toxicities of Some Herbicides to Six Species
                 of Freshwater Crustaceans.   Journal of the Water Pollution
                 Control Federation 42(8):1544-1550.

GS009521      Shah, P.V. and Gutrie, F.E. (1977) Dermal Absorption, Distribution
                 and the Fate of Six Pesticides in the Rabbit.  Pesticide
                 Management and Insecticide Resistance; Academic Press, NY, pgs.
                 547-554.

GS009508      Simmon, V.F.; Rosenkranz, H.S.; Zeiger, E.; Poirier,  L.A. (1979)
                 Mutagenic Activity of Chemical Carcinogens and  Related Compounds
                 in the Intraperitoneal Host-Mediated Assay.  Journal National
                 Cancer Institute 62:911-918.

00052653      Snelson, J.T. (1974) Amitrole: Joint FAO/WHO Meeting of Experts on
                 Pesticide Residues 1974: Document PB 227.  (Draft monograph:
                 Australia, Dept of Agriculture, unpublished study: CDL:243309-D)

00061351      Steinhoff, D.; Boehme, K. (1979) Aminotrazole (Amitrole)  Cancero-
                 genesis Test with Oral Administration to Rats:  Report No.  8450.
                 (Translation: unpublished study received Sep 22,  1980 under 264-
                 135; prepared by Bayer, AG, W. Germany,  submitted by Union Car-
                 bide Agricultural Products Co., Ambler,  PA; CDL:243312-A)

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00061340      Steinhoff, D.; Boehme, K.; Lorke, D.; et al.  (1978)  Aminotrazole
                 (Amitrole) Carcinogenicity Study on Orally Dosed  Golden Ham-
                 sters: Report No. 7521.  (Unpublished study received Sep 22,
                 1980 under 264-135; prepared by Bayer, AG, W.  Germany,  submitted
                 by Union Carbide Agricultural Products Co., Ambler,  PA; CDL:
                 243314-A)

00061348      Steinhoff, D.; Boehme, K.; Lorke, D.; et al.  (1978)  Aminotrazole
                 (Amitrole) Carcinogenesis Study with Oral  Administration to
                 Mice: Report No. 8490.  (Unpublished study received  Sep 22,
                 1980 under 264-135; prepared by Bayer, AG, W.  Germany,  submitted
                 by Union Carbide Agricultural Products Co., Ambler,  PA; CDL:
                 243313-A)

GS009520      Steinhoff, D.; Weber, H.; Mohr, U.; Boehme, K. (1983) Evaluation of
                 Amitrole (Aminottriazole) for Potential Carcinogenicity in Orally
                 Dosed Rats, Mice, and Golden Hampster. Toxicology and Applied
                 Pharmacology 69:161-169.

00033127      Sund, K.A.; Gordon, P.M.; Walworth, B.L. (1955) Agricultural Ap-
                 plications and Soil Residue Studies of 3-amino-l,2,4-triazole.
                 (Unpublished" study received Oct 11, 1955 under 264-68;  submitted
                 by Union Carbide Agricultural Products Co., Ambler,  PA; CDL:
                 001848-A)

00025435      Swabey, Y.H.; Schenk, C.F. (1963) Report on Algicides and  Aquatic
                 Herbicides,  (pp. 8-13 only; unpublished study received Mar 12,
                 1969 under OF0996; prepared by Ontario, Water  Resources Commis-
                 sion, Laboratory Div., Biology Branch, submitted  by  Geigy Chem-
                 ical Corp., New York, N.Y.; CDL:091713-B)

00036962      Thiegs, B.J.; Kaufman, D.D. (1965) Data in Support of the  Proposed
                 Use of Dowpon® Grass Killer for Summer Treatment  of  Perennial
                 Grasses in Small Grain Stubble.  (Unpublished  study  including
                 published data, received Jan 26, 1970 under 464-164; prepared
                 in cooperation with the U.S. Agricultural  Research Service,
                 Crops Research Div., submitted by Dow Chemical U.S.A.,  Midland,
                 Mich.; CDL:022950-A)

GS009507      Tjalve, H. (1974) Fetal Uptake and Embryogenetic  Effects of Amino-
                 triazole in Mice.  Archives of Toxicology  33:41-48.

00052659      Tjalve, H. (1975) The Distribution of Labelled Aminotiazole in
                 Mice,  Toxicology 3:49-67.  (Also in unpublished  submission
                 received Sep 22, 1980 under 264-135; submitted by Union Carbide
                 Agricultural Products Co., Ambler, PA; CDL:2433092-J)

00052645      Turner, D.M.; Gilbert, C.M. (1976) Evidence of metabolism  of C14
                 Amitrole in the Rat after Inhalation Administration: Project No.
                 291/lA.  Supplementary Rept., May 1976.  (Unpublished study re-
                 ceived Sep 22, 1980 under 264-135; prepared by Hazelton Labor-
                 atories Europe, Ltd., submitted by Union Carbide  Agricultural
                 Products Co., Ambler, PA; CDL:243310-C)

-------
00082174      Vidone, L.B.; Shaffer, C.B. (1958)  Report on Aminotriazole:  32-day
                 Repeated Feeding to Rats: Comparision of Effects of 1000  ppm
                 Fed on Alternative Days with 500 ppm Fed on Consective Days:
                 Report No. 58-4.  (Unpublished study received Dec 20,  1958 under
                 PP0210; submitted by American Cyanamid Co., New York,  N.Y.;  CDL:
                 090236-D)

GS009514      Weed Science Society of America (1979)  Herbicide Handbook.
                 4th edition.  Weed Science Society of America, Champaign, 111.

GS009503      Weir, R.J. (1958) Chronic Oral Administration - Beagle Dogs.  (Un-
                 published study prepared by Hazelton Laboratories, submitted by
                 Union Carbide Agricultural Products Co., Ambler, PA)

00052652      World Health Organization (1974) Amitrole: Joint Meeting  of  the
                 FAO Working Party of Experts on Pesticide Residues and the WHO
                 Expert Committee on Pesticide Residues: Rome, 2-11 December,  1974:
                 FAD/RES/74.4C.  (Extracted from V. 7 1974, IARC Monographs on the
                 Evaluation of the Carcinogenic Risk of Chemicals to Man;  English
                 only, unpublished study, CDL:243309-C)

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             INDEX OF CITATIONS USED IN THE DATA REQUIREMENTS CHARTS
                       REFERENCES LISTED IN NUMERICAL ORDER
MRID

00017800
00022923
00024959
00025435
00027115
00028434
00032045
00033124
00033127
00036935
00036962
00044017
00052643
00052644
00052645
00052646
00052647
00052648
00052649
00052652
00052653
00052658
00052659
00052660
00052661
00052662
00052665
00061340
00061348
00061349
00061351
00063956
00063598
00063599
00063601
00069171
00069192
00079923
00082174
00082176
00089104
05001497
05020819
05020822
GS009502
GS009503
GS009504
GS009505
AUTHOR

Crosby, D.G.; Tucker, R.K. (1966)
Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975)
McCann, J.A. (1972)
Swabey, Y.Hi; Schenk, C.F. (1963)
MacRae, I.C.; Alexander, M. (1965)
Keller, J.G. (1960)
Reichert, B.L.; Knoll, B.A. (1979)
American Chemical Paint Company (1955)
Sund, K.A.; Gordon, P.M.; Walworth, B.L. (1955)
Atkins, E.L.; et al. (1975)
Thiegs, BB.J.; Kaufman, D.D. (1965)
Helling, C.S. (1971)
Babish, J.G. (1977)
MacDonald, C.M.; Pullinger, D.H. (1976)
Turner, D.M.; Gilbert, C.M. (1976)
Brusick, D. (1975)
Prince, H.N. (1977)
Brusick, D. (1975)
Brusick, D. (1975)
World Health Organization (1974)
Snelson, J.T. (1974)
Fregly, M.J. (1968)
Tjalve, H. (1975)
Laamanen, I.; et al
Meretoja, T.; et al
Bamford, D.; et al.
Knickerbocker,
Steinhoff, D.;
      (1976)
      (1976)
     (1976)
M.; Stevens, K.R. (1978)
et al. (1978)
Steinhoff, D.; et al. (1978)
Iwan, G.R. (1978)
Steinhoff, D.; et al. (1979)
American Cyanamid Company (1957)
Fogleman, R.W. (1954)
Elsea, J.R. (1954)
Bagdon, R.E.; Shaffer, C.B.; Vidone, L.B. (1956)
American Cyanamid Company (1961)
Bond, C.E.; Lewis, R.H.; Fryer, J.L. (1960)
Rashid, K.A. (1974)
Vidone, L.B.; Shaffer, C.B. (1958)
Keller, J.G. (1959)
American Cyanamid Company (1959)
Sanders, H.O. (1970)
Bignami, M.; et al. (1977)
Carere, A.; et al. (1978)
Cox, G.E.; Re, T.A. (1978)
Weir, R.J. (1958)
Johnson, W.D.; Becci, P.J.; Parent, R.A. (1981)
Bionetics Research Laboratories, Inc. (1968)

-------
MRID             AUTHOR

GS009506         Gaines, T.B.; Kimbrough, R.D.; Linder, R.E. (1973)
GS009507         Tjalve, H. (1974)
GS009508         Simmon, V.F.; et al. (1979)
GS009509         Dunkel, V.C. (1979)
GS009510         Fang, S.C.; George, M.; Chang Yu, T. (1964)
GS009511         Fang, S.C.; Khanna, S.; Rao, A.Y. (1966)
GS009514         Weed Science Society of America (1979)
GS009515         McCann, J.A. (1976)
GS009516         McCann, J.A. (1976)
GS009517         Baugher, D.G.; et al. (1982)
GS009518         Alexander, N.M. (1959)
GS009519         Johnson, W.W.; Finley, M.T. (1980)
GS009520         Steinhoff, D.; Weber, H.; Mohr, U.; Boehme, K. (1983)
GS009521         Shah, P.V. and Gutrie, F.E. (1977)

-------
APPENDIX  II

-------
                                                                                          No.
                F1FHA SECTION 3(C)(2)(B) SUMMARY SHEET
                                                                                    6PA REGISTRATION NO.
PRODUCT NAME
APPUCANTS NAME
                                DATE GUIDANCE DOCUMENT ISSUED
  WWi respact to tha requinmant tn submit "janarie" dattimposad by tna F1FRA action 3(C)(2MB) notict containad in tha refxanad
  Guidanes Qocumant, I am responding in tna fallowing mannar.
    D1.  I wilt submit data in i timary mmnir to atisry tt>« following requirammts. If thi tan proctdum I will ua dwins from (or an nor
          aiBcifiid in) tfn fliqistntion Guidrtintt ortna Proncais eonttimd iff ttm Ripora of Export Groups to *» ChuntcaJj Group, 0 ECO
          Chamieai* Toting Prognmmt, I mdon tht protoenk-tRit I will use
    Cl  I hm wroTBd intn an aqrwrnmtwrth on* or mort othir ugauum undar F1FHA action 3(C)(2(B)(ii) to awry the following data
          nquirrnneRO. Tlia too, and any rtquind protoeois, will IM aibmittad to EPA by:
 'NAME OF OTHER REGISTRANT
    1_J 1  I sndoa a eampiattd "Cartiflcation of Attampt to Entar Into an Agriamant with Other fleqatrams for Oaveiopment of Data" with
          mpact to tha following data, requirements
        .  I reouast that you amand my registration by daieting tha following uaa (this option is not available to applicants for new products):
    D 5. I rtquast voluntary eancallation of tha registration of this product (This option is not availabia to applicants for naw products.)
REGISTRANTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8880-1 (10-82)

-------
APPENDIX III

-------
                                                                            OMB fioon *  Ho. 20004468 (ExoinK  12-31-33i_
(To quatify, eam'fyA^
1. 1 am duly authorized
merits of a Notice- un
to submit data cancer
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
fourinmsi FOR DEVELOPMENT OF DATA
to represent the following firm(s) who are subject to the require-
der F1FRA Section 3(c)<2)(B) contained in a Guidance Document
nirtg the active ino/edienti
NAME Of «RM




aUIOANCE DOCUMENT DATE
ACTIVE INOR6OIENT
EPA COMPANY NUMBER

	


(This firm or grouo 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 tMeasiary. However, my firm would prefer to enter
into an agreement with one or mom other registrants to develop, jointly, or to share in th» oat of developing, the following required
items 'or data:
f *
1 My firm has offered in writing to anarinto sudran agreement. Capias of tiie offers an attadied.Tlin offer w«» irrevocable and included an offer to be
oound by an arbitration dtcsion under FiFHA Section 3(d(2)(B)(iii) if final agreement on all turn could not be readied otherwise. This offirwas made
to me following firm(s) on die following date(x):
NAME OP FIRM

*
*

DATE OF OFTCR



^.
4. My firm requests that EPA not suspend the registration^) of my firm's produces), if any of the firms named in paragraph (3) above
  have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
  m» whether my firm must submit data to avoid suspension of its registration^) under F1FRA Section 3(c)(2)(B). (This statement
  does not apply to applicants for new products.}  I give EPA permission to disclose this statement upon request.
TYP8O NAME
SIGNATURE
OATH

-------
APPENDIX IV

-------
                       PRODUCT SPECIFIC DATA REPORT



EPA Registration No.	Guidance Document for_




                                                 Date
Registration
Guideline No.
§158.20
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
Name of Test

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
























I am complying with
data requirements by
Citing MRIDt
























Miscibility
Submit-
ting
Data
(At-
tached)

























(For EPA Use Only)
Accession Numbers
Assigned


























-------
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Corrosion
characteristics
Dielectric break-
down voltage

Acute oral LD-50,
rat
Acute dermal
LI>-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion





































-------
APPENDIX V-l

-------
1142.10

cacy, and safely  of the formulated
end-use product, may not coiulder any
data  as supporting  Ilia application.
except the following data:
  (I) The data |ho applicant liaa sub-
mitted to EPA under paragraph (b) pi
fhls section;
  (3) Other  data  pertaining to  (he
aafety of the  producl'a active Ingredi-
ent*, rather than to the aafety of the
end-use product; and
  (3) Existing tolerancea. food additive
regulations,  exemption*, and other
clearance* loaned  under  the federal
Food. Drug, and Cosmetic Act.
  (el If the applicant knows ihat any
Item of data lie submitted under thuj
section wan generated by (or at the ex-
pense of) another person who orlglna)-
jy submitted the data t,P EPA (or It*
predecessor. USDA) on or after Janu-
ary 1, 1070. to support an application
for  registration,   experimental   uso
permit, or amendment adding a, new
use to an existing  registration, or for
rcregldtratlon  (unless  the   applicant
and the original data submitter  |iave
reached  written  agreement  on  the
amount and the tenni of payment of
any compensation that may be  pay-
able     under     PIP11A    aect|pi»
3(D>;
  (3) An Identification of the |tem(a)
of data to which the offer applies;
  (4) An offer to commence negotia-
tions to ascertain  the amount and
terms of compensation to be paid; and
  (6) The applicant's name,  address.
and telephone number.
  (f) If the  applicant's product  con-
tains any active Ingredient other  than
those llmt are present solely because
of  the Incorporation Into the product.
dijrlng  formulation,  of one Of  more
other  registered   pesticide  products
purchased  from   another  producer.
then the applicant *|ial| also comply
   fill* 40—fro(«ctlop of Envlronptan|

with | m 0 6 aa to such active Ingredi-
ent, and the application ahall contain
an acknowledgment that for purposes
of PIPHA section 3(c)(|MD) the appli-
cation relies on (and any resulting reg-
istration should bo regarded as If ft
were based on the Adnilnlstialor'* con-
sideration of) the following data:
  (|) All data submitted or specifically
cited  by the applicant  In support  of
fhe registration; and
  (3)  Bach other Item of data In the
'Agency's files which:
  (|) Concerns the properties or effects,
of any suc|i actjve Ingredient; and .
  (II)  Is one of  tile types of data, that
EP4 would require to be submitted for
scientific review by EPA If the appli-
cant  sought  the  lnlf|a|  registration
under PIFRA  flection  l(c)(6)  of a
product with composition and Intend-
ed uses Identical to those proposed for
the applicant's product, under the
data  requirement*  In effect on the
date  EPA approve*  the applicant's
present application.

(See*. 1. f. and 31 of FlFflA. M amend*), 1
P B O. Ill elugt
IU fit HftM. M.f II. |S7»]

| 111 !•  Labeling rHulr«mcff|f.
  (a)  General-(I)  Content*  oj  f/»«
label. Every  pesticide product*  *hal|
bear  a  label  containing the Informa-
tion specified by the Act and the regu-
lation* In this Part. The content* of a
label  must show clearly *nd promi-
nently the following: .
  (!) The name, brand, or trademark
under which the product I*, sold a* pre-
scribed In  paragraph (b) of this sec-
tion;
  (II)  The  name and address of the
producer,  registrant, or person  for
whom produced a* prescribed In para-
graph (c) of llila section;
  (III) The net  contents a* prescribed
In paragraph (d) of this section;
  (!v)   The    product   registration
pumber aa prescribed In paragraph (e)
of this section;
  (v)  The  producing  establishment
(lumber a* prescribed |n paragraph (f)
of this aecl Ion;
  (vl) An Ingredient statement aa pre-
scribe*! |r|  paragraph (g) of  this tec-
lion;
                                                                                        er
— |6n. v|roru«aii|«d Pr0|«t (Ion Ag»ncy'                       tf lei. 10

                              proprlate provisions of 40 CPU I'ujls
                              (10-180. concerning the transportation
                              of hazardous Jnalt rials, and specifical-
                              ly those provisions concerning the .la-
                              beling, (narking and placarding of haz-
                                         '
Chapl

  (vll) Warning or precautionary state-
ments as prescribed In  paragraph ill)
of this section:                       >
  (*lll) The directions for  use M pre-
scribed In paragraph (I)  of thh) section;
•lid
 ' (Ix) The  use classification^) aa pre-
scribed |n paragraph (J>  of this *ectlon.|
  (3) Prominence and leplbUUif. (I) A|l
words, statements, graphic representa-
tions, designs or other Information re-
quired  on the labeling  by  the Act of
the regulation*  |n thin  part must  be
clearly legible to a person w|||i normal
vision,  and must be  placed with  such,
consplciiousnea*  (as  compared  wilt)
Pther words, aiafemenla.  designs,  or
graphic matter  on the  labeling) and
expressed hi such terms  M  to render It
likely to be read and understood by
the ordinary Individual  under custom-
ary conditions of purchase and W«-,
  (II) All required label lent must: <|
  (A) Be set |ri d point or larger  type;
  (B) Appear on a  clear  contrasting
background; and
  (Ol Not be obscured or crowded.
  I)) Language to be \tted. All required
label or labeling texj. s|ial| appear In
the English language.  Ifowever. the
Agency  may require or  the applicant
nisy propose additional (ext In other
languages aa Is considered necessary fa
protect  the public.  When  additional
(ext In another language la necessary,
all labeling requirement*)  will be ap-
plied equally |o  both the English and
other language  versions of the label-
ing.
  (4) Placement  oj Label—t\t QeneraL
The label ahall appear on or be secure-
ly attached to the Immediate contain-
er of the pesticide product, for pur-
poses  of this Section,  and the  niU-
prand .ig provision*  of  the Act. "*e-
eurely  attached" shall  mean  that  •
label can reasonably be expected  to
remain affixed during the  foreseeable
conditions and period of uae. If the lin-
piedlate container Is  enclosed within a
wrapper pr outside container through
which the label cannot be clearly read,
jhe  |abe| must  also be aecnrely at-
tached to such outside wrapper or con-
tainer; If It  |a a part of f lie  package a*
customarily distributed pr sold.
  (Ill Tank  cart anil other bulk  con-
        (A) Tranipor/ufioM. While  *
        product la |n transit, the ap-
                              ardous piate'rlala and the vehicles car-
                              rying them, define the  basic Federal
                              requirements.  In addition,  when any
                              registered -pesticide  product la  trans
                              ported In a (auk cur. tank truck  or
                              other mobile'or portable hulk contain-
                              er, a copy of the accepted label must
                              be attached to t|ie shipping paper*.
                              and left with t|iu consignee at Ilio lime
                              pf delivery.
                                (B) Storage.  When  pesticide  prod-
                              ucts are stored  In bulk  containers.
                              whether mobile or stationary,  which
                              feniali) In the  custody of Hie uucr. a
                              copy of the label of labeling, Including
                              all appropriate direction* for use. shall
                              be securely attached to the container
                              In the Immediate vicinity of tin: ills
                              Charge control valve.
                                (B) false or  mlileadtno ttatementt.
                              Pursuant to section 3«j)(|MA) of the
                              Act, a pesticide of o device declared
                              •iibject to the Act pursuant to 1103.16.
                              I* mlsbranded  If Its labeling la false or
                              misleading In any particular Including
                              both  pestlcldal  and  non pcstlcldul
                              claim*. Examples of statement* or rep-
                              resentations In the labeling which con-
                              stitute inlsbrandlng Include:
                                (|) A false or misleading  statement
                              concerning the composition of  the
                              product;
                                (II) A false or misleading  statement
                              concerning the effectiveness of the
                              product a* a pesticide or device;
                                (III) A false or misleading  statement
                              about the  value of the  product for
                              purposes other than as a pesticide or
                              device;
                                (Iv) A false or misleading comparison
                              with other pesticides or devices;
                                (y) Any statement directly or indi-
                              rectly Implying that (lie pesticide or
                              device la recommended or endorsed by
                              any  agency of  the  Federal (luvcrn-
                              ment;
                               (vl) The name of a pesticide which
                              contain* two or more principal  active
                              Ingredient* If  the name  suggests one
                              or more but  not all  such  principal
                              active  Ingredients, even  though  the
                              pomes  of the  other Ingredient* are
                              si tiled elsewhere In the labeling;

-------
 1142.10

  (vll> A true statement used In such ft
 way ma to |lv« a (aloe or misleading Im-
 pression to Uio purchaser;
   label disclaimers which negate
 or detract from Ubcllng statements re-
 quired under the Act and these regula-
 tions;
  (Ix) Claims as  to the safely of the
 pesticide or Ita Ingredient*. Including
statements such aa "safe." "nonpolson-
ous." "nonlnjiirlous."  "harmless" Of
"nontoxlo to human* anil pel*"  with
or without such a qualifying phrase as.
"when used aa directed"; am)
       . ._	. _ M..w».»wl« , Klllf
     (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";
      Name, brand,  or trademark. (I)
  The name,  brand, or trademark under
  which  the  pesticide product  la sold
  shall appear on the  front pane) of the
  label.
   (3) No name, brand, or trademark
  may appear on the label which:
   (I) Is false or misleading, or
   (II) Has not been approved by the
  Administrator through registration or
  supplemental registration a* an addi-
  tional name pursuant to | !03.l(bM|).
   (c) Name  and address of  producer,
  registrant, or  person for whom pro-
  duced. An unqualified name and ad-
  dress given on the label shall be con-
  sidered as the name and address of the
  producer. If the registrant'*  name ap-
  pears on the label and the registrant Is
I not the producer, or If the name of the
I person for  whom  the pesticide waa
 produced appears on t|ie label. It must
      IllU 4Q—f rotation of f nvlfonmanf

   ba qualified by appropriate  wording
   such aa "Packed for • t V "Plstrllnit
   ed by » •  V or "Bold by • • »" to show
   that  the name hi not that of the pro-
   ducer.  •
     (d) Net weight-or meature oj con-
   tenti. (I) The net weight  or measure
   of content shall ba exclusive of wrap-
   pers or other material*  and ahal)  be
   the average content unlesa explicitly
   stated as a minimum quantity.
    (3)  If the pesticide I*  a liquid, the
   net  content statement  shall  ba  In
   terms of liquid measure at 88* ft* (30*C)
   and ihall he expressed In conventional
   American  unit* of fluid, ouncea, p|nU,
   quarts, and gallon*.
    (»If the pesticide hi solid or aemlso-
   lid. viscous or pressurized, or U a mix-
   ture of liquid and solid, the not con-
   tent statement  shall be  |n terms of
   Weight  expressed   a*   avoirdupois
  pounds and ounce*.
    (4) In all case*, net content shall be
  stated In term* of the largest suitable
  imlts. I.e., "I pound |0 ounces" rather
  than "34 ounces."
    (6) In addition to the required units ''
  specified, net  content may be  ex-
  pressed In metric unit*.
   (0) Variation above minimum  con-
  tent er around an average I* permissi-
  ble only to the  extent  that It repre-
  sents deviation  unavoidable In  good
  manufacturing   practice.    Variation
  below a staled minimum la not permit-
  ted. |n no case shall the average con-
  tent of the package* In a shipment fall
  below the stated average content.
   (o)  product  reglttrallon  number.
 The registration number assigned to
 the pe«tlc|de product  at the time of
 registration shall appear on the label.
 preceded by the  phraae "BPA Regis-
 tration NO.," or the phrase "KPA Reg.
 No." The registration number shall be
 set In type of a size and style similar to
 oilier print  on that part of the label
 on which It appear* and shall run par-
 allel  to It.  The registration number
 and the required  Identifying phrase
 •hall not appear In such  a  manner as
 |o suggest or Imply recommendation
 or endorsement of the product by the
 Agency.
  (f) producing ettabllthinenti regli-
 (ration nuntber. The producing estab-
lishment registration number preced-
ed by the phrase "|fiPA Bat.", of ||i«
 Chapter f—favlraninfn|al frof««fl<

 final establishment at which |h« proli.
 pet was produced may appear In anv
 suitable location on the |abel or'|n,","a
 dlale container. It miist appear fin Ilia
 wrapper or outside  container of  the
 package If the BPA eslabllshmen reg
 Ulrsl on  number  on  the Immediate
 container  cannot  be  clearly  re«d
 through such wrapper or container
 ^tngrallent ,tatement~n> Oentr-
 al The label of each  pesticide product
 must bear a statement which conUIn*
 the name and percentage by weight  of
each active Ingredient, the total
ecnlftrn hu ujuioi.i „«  .1. >    . : •
                                                                                                                                                      fi 162 10
                                                                                  .      s         *   'lwl "l-
                                                                               ents; and If the pesticide contains ar-
                                                                               senic In any form, a statement of the
                                                                               percentage, of Mai and water so ,,bht
                                                                               arsenic  calculated  a*  elemental  „
                                                                                               «"«'««Ua,u must La
                                                                                                _   T	,  .»..«••? mf9
                                                                              designated by the term "active Ingredi-
                                                                              ents" and the Inert Ingredient* by tin*
                                                                              Icrm "Inert Ingredients." or the sliigu"
                                                                              jar forms of these term* when appro-'
                                                                              prlaie.  Both  term*  shall  he |n  Hie
                                                                              same type size, be aligned |o t|>e aame
                                                                              margin and be equally prominent. Tl«e
                                                                              statement "Inert Ingredient*, none" I*
                                                                              pot required for pesticide* which  eon-
                                                                            •  lain  |0tt percent  active lngred|ei)La.
                                                                              Unleu the Ingredient statement  la a
                                                                              complete analysis  of the pesticide, the
                                                                              Icrm "analysis" shall not be used M •
                                                                              heading for the Ingredient statement
                                                                              <3) Poiltlon o/ Ingredient *tateinef\L
                                                                             (I) The Ingredient statement  |* nor-
                                                                             mally required on the front panel of
                                                                             the label, ff  there I* an ouUlde con-
                                                                             tainer or wrapper  through which  thp
                                                                             Ingredient statement cannot be clearly
                                                                            read,  the  Ingredient statement mns|.
                                                                            also appear on *uc|i outside container
                                                                            pr wrapper. If the size or form  of the
                                                                            package make*  It  Impracticable  to
                                                                            place I he Ingredient statement on the
                                                                            front  panel of  the label, permission
                                                                            l»ay be granted for  the Ingredient
                                                                            f I element to appear elsewhere.
                                                                              (ID The lent of the Ingredient  state
                                                                            went must run  parallel  with  other
                                                                            Icxt on the panel on which It appears.
                                                                            and  must  be  clearly distinguishable
                                                                            from and must not be placed <» Hie
                                                                            My of other text-
                                                                             ill «-— •   -r
                                                                                            be  the'
                                                                           K-rVBrJ! "i^f h/one,  fo,
                                                                                 ™  *na «he«ilcal  fiame.  The
     common name may be used alone only
      (f jl I* well Known. If no common name
      iaa 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 ha* been accepted as a common
     name-by the Administrator under the
     authority of Section 3fi  pose  a
 hazard to man or the environment.
  (h)  Warning*  and  precautionary
 Statement*,  flequlred  warnings  and      I
 precautionary statements concerning
 ihe  general  area* of   toxlcologlcal      '
 hazard Including hazard to children,
environmental htfeurd, and physical or
chemical hazard full Into two i;roni>s:

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  9 ua.14

  those required on ilio front panel of
  the  labeling  and those  which  may
  appear  elsewhere.  Specific  require-
  ments concerning content, placement,
  type size,  and prontjnence arc given
  below.
    (I) llequircit front panel sfafemeiif*.
  With  the  exception  of  the  child
                                fill* 40—frotocljan «l f nvlr0nmihif

                              hazard warning statement, the text re-
                              quired on the front pane) ol the lapel
                              la determined by the Toxlclty Catego-
                              ry of the pesticide. The category U M-
                              algned on the  basis of  the highest
                              hazard shown by any of the Indicator*
                              In the table below:
                       »
                                         _t
  OidlO..	 Ity»» •«• IncUSim M  f«w«tOSw>MOuia/ka f ion 600 »uu Moo •«/ Oi«*tM *>M tooa M/
                 «•/!«.                  '         k»             >•
                               f HMI * SMI «*o/*«.... fiO*« «nU20«ylM. Of*M« |l«t M we/MM.

                IV u *«i b**M*>0 too f iu» too s»u soao	_ fioMt.ooasinigo.aoo.. o»Mi«f «w> 20.000

                                                              Nakiktilan.
	 Catioiki*. cam*(«<% not i«»*ia«* Irmulaa •! l|
                                              M»d«aU tllUSMI *l If
                                                                       -t-
    <|) Human haaard tional word—(A)
.  faxtctty Catepory I. All pesticide prod-
  ucts meeting the criteria of Toilclty
  Category  I  shall bear on  the front
  panel the signal word "Danger." In ad-
  dition If the product waa assigned to
  Toxlclty Category I on the basis of IU
  oral. Inhalation or dermal toxlclty   Toiictlv Category II Al| pes|l-
  clde producta meeting the criteria of
  Toxlclty Category II ahall bear on the
  front  panel  the  signal word "Warn-
  ing."
   (C) ToxMty Category Iff. All pesti-
  cide producU meeting the criteria of
  Toxlclty Category III ahall bear on
  the front panel the digital word "Cau-
  tion."
   (D) Toxtcttv Category IV- All pesll-
  clde producla meeting the criteria of
  Toxlclty Category IV ahall bear on the
  front panel the signal word "Caution."
   If U) I'J« of tlgnal word*. Uue of  any
  Ignal wprd(s) associated with a higher
 Toxlclly Category  la  not permitted
                             except  when the Agency determine*
                             that such labeling la necessary to pre-
                             vent unreasonable adverse effects oij
                             man or the environment. In no case
                             ahall more t|ian  one human hazard
                             algna.1 word appear on the front  panel
                             of a label.
                               (II) Child hazard warning, livery pes-
                             ticide product label ahall bear on the
                             front panel the statement "keep out of
                             reach  of  children."  Only  In  cases
                             where  the likelihood of contact with
                             children during distribution, market-
                             ing, storage or Use la demonstrated by
                             the applicant to bo extremely remote.
                             or U the nature of the pesticide Is such
                             that It  Is approved for use on Infants
                             or small children, may the AdmlnUlra-
                             for waive this requirement.
                               (Ill) Statement  oj f radical  treat-
                             ment—(Al   Tojficity  Category   I.  A
                             statement of practical treatment  (llrw
                             aid or other) shall appear on the  front
                              Kanel of the label of all pesticides fall-
                              ig Into Toxlclty  Category  I on Ifc*
                             basis of oral, Inhalation or dermal !oi-
                             Idly.  The   Agency  may.  however.
                             permit  reasonable variations In tn«
                             placement of the statement of practi-
                             cal  treatment Is some reference  «ucn
                             as "Bee statement of practical trc"
                             ntcnt on back panel" appears on •'"
  Chapter I — fnvlranm«q|<>|
  front panel near  the word "Poison"
  and the skull and croaaponea.
   (0) Other toxjclty categories  The
  statement of practical treatment U not
  required on the front panel except aa
  described In paragraph (liMINIUMA) of
  t)ils section. The applicant may.  how-
  ever, (nclude such a front panel state-
  ment  at  his  option-  fllalenienU of
 practical treatment are.  however, re-
 quired  elsewhere  on  t|io  (abel  In
 accort| with paragraph (li)(2) of this
 tecflpn. If  they do not  appear on th*
 front panel.                 '
  (|v) Placement a,ntt promfn«nc«. A||
 Hie require front panel wanting state-
 ments, shall  be groupet)  together on
 the label, and shall  appear with suffi-
 cient prominence  relative  to  other
 front panel text and graphic material
 to wake them,  unlikely to he over-
 look ecj under customary conditions of
 purcliase apd use. The following table
•how* the mln|i|ium type size requlre-
nienU for  the  front panel  warnljig
statement*, on various sizes of labels:
                                        p«ncy
                                                                             10
           ar
                                                                                                                                     P4MO*
                                                                                                                                               PlMttt
                                                                                                                                                      M
                                                                                                                                                      I*
                                                                                                                                                     a
                                                                                                                                                    ta
                                                                                                                                                    u
    f 91 Other required wamlngt and pre-
  cautionary ttalament*.  The  warnings
  and  precautionary statements as  re-
  quired below ahall appear together on
  the label under the general heading
  "Precautionary    Statements"   and
  under   appropriate   subheadings  of
  "Hazard to Humana and Domestic Ani-
  mals."  "environmental  Hazard" and
  ''Physical or Chemical Hazard."
i  (I) flaiartt to humans and dometlio
\ animal*. (A) \Vi\ere a hazard exists to
 . humans of domestic animals. pr<;cuti-
 (lonary staleinenta are  required Indi-
 cating  t|te  particular   hazard,  the
 routefa) of exposure and the precau-
 tions  (o he taken to avoid accident.
 Injury or <|amage. The' precautionary
 paragraph ahall  be Immediately pin-
 Ceded by the appropriate hazard ulgnal
 word.
  (lit The following table depicts typi-
 cal precautionary  statements.  These
 statements must be modified or  ex-
 panded to tcfleet specific hazards.
     .. Mn k* Ul«l S «W**IMW| Ik4wl*d <* «Lxnl>«»l *U
        •blMMAl* iMMrwl |.
     . IhimU k *M*IMV*« |k4ul«l ai  »fc»nrt>»l »xough Sw
        »Wn| AvuU k•! *U
        tlilwwnl i«t**J |

     • INa (••uukanuy «blMiu IM^M! | ,			
       «Ut lul-
       Uttonl Do not aM *» •»••. «a «fcln. a> •*> *>-
       kig  W»«« B°ei^«« o> !•£• MiluU tiul ii<4i«
       BtovM «4i~l lumSng ll*i*i
    ul pal kt m«, on am. « on dowry HumU V >»*M.wi lV piufHteU ti*l «lil >UI*uMiil mi***! I AMMd catiuct wUi tUn. *y«» w clull^ig hi MM al cunud tmn*Jal«ly Smli *^*t « >ilA »«ii |4*ily «f ~»U. O4l HHukcd MlonSWi S liihlkM Mf-
    -------
    I 1*3-10
    
    lions  to  avoid   potential  accldenf.
    Injury or  damage. Example*  of the
    hazard statement* and  (he circum-
    stance* under which they are required,
    follow:
      (A) If  a  pesticide Intended for out-
    door line contalna an active Ingredient
    with a mammalian acuta oral f .p- of
    100 or less, the atalemenl "Thta Pestl-
    clde la Toxld to Wildlife" la required..
      esllclde U Toxic
    |o Hall"  la  required.
      .. of 100
    mg/lig or  lesa. or a aubacute dietary
    I/!., of 600 ppm or lea*, the statement
    'Tl»ls I'eallclde la Tox|o to Wildlife" la
    required.
           fill* 40—ffoUcllon of! Environment
    
    
          hrU) required.
          (&) For i|»e» Involving foliar applica-
        tion to agricultural cfopa.  forest*, or
        ahade  treea. or for  mosquito  abate-
        ment treatment*,  pesticide*  tox|c to
        pollinating Insect* must bear approjirl-
        ate label  cautions.
         '(F) For all outdoor uaea other than
        aquatic  application*  the  label  must
        bear the eaullon "Keep put  of lake*.
        ponds or atreama. |)o not contaminate
        Water by cleaning pf equipment or dls-.
        poaal of wastes."
          (Ill) fhvitcal or cltemlcal  hasaidt.
        Warning statement* on the f lammabll-
        Ity or explosive characteristic*  of the
        pesticide are required a* f ollowa;
                          '       |A| fWtaaiMUM> CUHIMHtH*
    
    fIa4i puM al at batM W F. S Iwa k> a fcuifcaU al f «b«iMly lamiulila. Cuniantt undaf ataaama. lUap amy ken fca.
      any kalna auanlng          	ayaita. ami fcaalad autlaCM Ou not puncha-a Of ktdnwala aoniaU
                                       ai. E«puaK« k> Iao4>a away from haal. apaika.
      law* anlonalon la anna (Man |4 k (u^ al f abiaflcf  and c«Mn IUM Ou iwn punca.ua at kuJftwala conUktaf-f
      cJ • li torn Via tuna                     to UnyMiluM aboua tio'FiMycauaalMulir
    AS adMf piatcuriiad coniafciaia			..	Camanla undw |M*«4uia Ou nol baa of aluia
                                       •ama. Oo not ourcWa or liidnafala coiilalitaf
                                       paialuita abowa 11ft" f May cauaa butting.
                                (I) NO
                                          ICO CllMIAIHtll*
    AUM W f (ml am MM «0- F	
    Aim.* M- F ud nol Ov« |la* f
                                                       xny kan •>•
                  kOM |M«| and QIMA f am^
    pa ao4 UM o> IKK* AMI toal Of cp«k lama.
                                                                      and l»*Ud »»
      (I) Dlreciloiu /or f/M- Placement tj iHrcclloni /or uic.
    Dlrectlona may appear on any portion
        of  the  label  provided thai  they ar*
        conaplcuoua enough to bo  eaully re«4
        by  l|io  uuer of the peatlclde product-
        Dlreclloiu (or uae may  appear tin
        printed or graphic matter which ac
        compunlea the peat|clda provided tli»fc
          l
        leulleU or circular!, auch M "See d
        recllonn In the enclosed, circular:" *»
    
                         fo r«aufr0>neiif for
                /or |»e—(A) lletalled dlreo-
       (loita for liae may be pmltted; from |a-
       pellng of peotlcldea which are lntende<|
       for uae pnly by maoufacturerii of prod-
       UcU other  than penllclde producU In
       fhelr regular inaniifacti|rli>8 propeiwea.
       jirpyl4e4 Mlgt:
        (J) The label clearly s|iow* f|iat thp
      product Is  Intended for uae  pnly In
      manufActurlng processes and apeclfle*
      jhe type(*l of product* Involved.
        (1) Adequate Information  *uc||  a*
      technical data aheel* or bulletins. I*
      available to the  trade specifying the
      type  of  product  Involved  and  II*
    ' proper use In manufacturing process-
      es
       (J) The product will  not  coma Into
      the hand* of the general public except
      after Incorporation Into finished prc-d.-
      ucU; and,
       <4> The Administrator determine*
      that auch direction* are not necessary
      to  prevent unreasonable adyerap ef-
      fects on man or the environment.
       Ip) Detailed direction* for use. may
      be omitted from the  labeling of pestf-
      clde product* for which sole Is limited
      to physician*, veterinarian*. Pf  drug-
      ibis, provided that:
       (f) The label clearly states that thp
     product I* for use only by physlclaua
     Pr veterinarian*;
       41)  The  Administrator  determine*
     t|iat such directions are hot necessary
     to prevent unreasonable adverse ef-
     fect* on man  or the environment; and
      4J) The product  b also a drug and
     regulated under the provision* of the
     Federal Food. Drug and Cosmetic Act.
      (C) Detailed direction* for  use  may
     be omitted from the labeling of pesti-
     cide products  which are  Intended for
     u«e only by formtilator*  In preparing
    pesticides for  sale to the public,  pro-
    tided that:
      ff)  There  Is  Information  readily
    available to the  formulator* on  the
    toiii|mauii>n. toxlclty. methods of  use.
    •uplkable restrictions  or limitation*.
          it} The |abe| cfearly stale* that  the
        product  hi  Intended  for  use only In
        |tianufacti|r|ng.  formulating, mixing.
        or repacking for use a* a pesticide and
        specifies the lype(s) of pesticide prod
      [  iicls involved;
        ' (|) The product a* finally  manufac-
        tured,  formulated,  mixed, or repack-
        aged Is registered; and
         44) The  Administrator  determines
        tliaf such directions are not necessary
        to  prevent  unreasonable  adverse  ef-
       fecta on man or the environment.
        <)) Cuittenlt  a/ Utrecllont far U»e.
       T|ie direction* for  use  shall Include
       the following, under the headings "Di-
       rection* for Use":'
        <|) The atatement of use classifica-
       tion as prescribed In Ida. 104J) Immedi-
       ately under  t!»e  heading  "Dlrectlona
       for Use."
        (II)  Immediately  below  the state-
      ment of use classification,  the state-
      ment "It I* a violation of Federal law
      to use this product In a manner Incon-
      sUtent with Its labeling."
        (Ill) The slices) of application, as for
      example the  crops, animals, area*, or
      objects to be treated.
     •  (Iv)  The target  pest(s)  associated
      wllli each site.
        (v) The dosage rate associated with
     each site and pest.
        (vO.The  method of application. In-
     cluding Instructions for dilution,. If re-
     quired, and. type(s) of application ap-
     paratus or equipment required.
       (vll) The frequency and timing of ap-
     plications necessary to obtain effective
     result* without causing  unreasonable
     adverse effects, on the environment.
       (vlll) Specific limitations on reentry
     to area* where t|ie |M>stlclde has been
     applied,   meeting   the  requirement*
     concerning  reentry  provided by  40
     C'FR Part 170.
      4lx)  Specific directions  concerning
     the dtorage and disposal of the pesti-
     cide and It* container, meeting the  re-
     quirement* of 40 CMC Fart 166. These
     Instructions  shall  be groti|»ed and
    appear under  the heading  "Storage
    and ptsposu|."  This heading must  be
    

    -------
                  1 142.1 T
                  S0t lit type Of the SUM minimum Sizes
                  a* required for the child hazard w*rn-
                  JaKSeeTaole in i lailtthXlXivu
                    (x) Any up^<»««;<. and appear-
                                                        ir^y with. •"f*|'***pg prominence relative
                                                        to other rjax »*H cnphxc rmffr*^! on
                                                                 panel- to otaJce It "^mf«iy to
                           mar only t» appitod under
                                                        be orerlootoed. imder customary condi-
                                                        tions of purchase and use. the  state*
                                                        nj»ff "Sescricted. TJse Pesticide"
                  Which l^lft-  >rtm
    section: and anail be marketed as aepm-
         products- wttii dlff eresc
                  only for general usetaj and the other
                  beartnr directions for restricted useia)
                  exeecc.tfaat.lf a. produce baa bocir re-
                  stricted osets; and feneraiuaeia;. both
                  of these uses may appear on » product
                  landed for restricted- uaeu. Such prod*
                  acctahaU be-fflibjectto the provisions:
                  of i IB3.10CJX2X
                    (1} GcnmL Us* Oaaifleattan. ?estt>
                  dd«- products- h««^Tiy directions: for
                  TBiafiF  classified general T*^aP  be la-
                  beled with the fxact words- "CeneraL
    only for those uses covered by the C&r-
          Applicator's- ^wflf^'*t^rm_ "  If,
             other- iaii"|a*
    -------
    APPENDIX V-2
    

    -------
    LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED (REFER TO THE SAMPLE LABELS FOLLOWING)
    ITEM
    1
    2
    3
    4
    5
    6A
    6B
    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 front
    panel or end
    of label text
    Front panel
    Front panel,
    immediately
    before or
    following
    Reg. No.
    Immediately
    following
    product name
    Directly below
    the main
    ingredients
    statement
    
    Above signal
    word
    Immediately
    below child
    hazard
    warning
    COMMENTS
    
    If registrant is not the producer, must
    be qualified by "Packed for . . .,"
    "Distributed by. . .," etc.
    May be in metric units in addition to
    U.S. units
    Must be in similar type size and run
    parallel to other type.
    May appear on the container instead of
    the label.
    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.
    

    -------
    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
    Environmental
    hazards
    APPLICABILITY
    OF REQUIREMENT
    All products
    which are Cat-
    egory I based
    on oral, der-
    mal, or inhala-
    tion toxicity
    All products
    in Categories
    I, II, and III
    All products
    where pre-
    cautionary
    labeling
    appears on
    other than
    front panel.
    All products
    All products
    in Categories
    I, II, and III
    All products
    PLACEMENT ON LABEL
    REQUIRED
    Front panel
    Category I:
    Front panel
    unless refer-
    ral statement
    is used.
    Others:
    Grouped with
    side panel
    precautionary
    statements .
    Front panel
    None
    None
    None
    PREFERRED
    Both in close
    proximity to
    signal word
    Front panel
    for all.
    
    Top or side
    of back panel
    preceding
    directions
    for use
    Same as above
    Same as above
    COMMENTS
    
    
    
    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.
    

    -------
    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
    cholinesterase
    inhibitors
    All products
    i
    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
    
    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
    

    -------
       PRODUCT
    
        NAME
      CAUTION
    General Use Pesticide
      RESTRICTED USE
        PESTICIDE
      PRODUCT
         NAME
    KEEP OUT OF REACH OF CHUJHEN
    
      OANGEH^-aOISON
    
           • «
                                         Reatrieted Use Pesticide
    

    -------
    APPENDIX V-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 than 18 inches
    long at a distance of
    6 inches from the
    valve opening.
    
    ALL OTHER PRESSURIZED
    CONTAINERS
    II.  Non-Pressurized Containers
    
        A.  Flashpoint at or below
            20°F.
        B.  Flashpoint above 20°F
            and over 80°F.
    
        C.  Flashpoint over 80°F
            and not over 150°F.
    
        D.  Flashpoint above
            150°F.
                                  Required Label Statement
    Extremely flammable.
    Contents under pressure.
    Keep away from fire, sparks,
    and heated surfaces.  Do not
    puncture or incinerate
    container.  Exposure to
    temperatures above 130°F
    may cause bursting.
    
    Flammable.  Contents under
    pressure.  Keep away from
    heat, sparks, and flame.  Do
    not puncture or incinerate
    container.  Exposure to
    temperatures above 130°F
    may cause bursting.
    
    Contents under pressure.
    Do not use or store near
    heat or open flame.  Do not
    puncture or incinerate
    container.  Exposure to
    temperatures above 130°F
    may cause bursting.
                                  Extremely flammable.  Keep
                                  away from fire, sparks, and
                                  heated surfaces.
    
                                  Flammable.  Keep away from
                                  heat and open flame.
    
                                  Do not use or store near
                                  heat and open flame.
    
                                  None required.
    

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    APPENDIX V-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 the directions for use portion of
    the label under the heading STORAGE AND DISPOSAL.  Products
    intended solely for domestic use need not include the headino
    "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
    Each registrant must develop his own storage instructions,
    considering, when applicable, the following factors:
    
    1.  Conditions of storage that might alter the composition or
        usefulness of the pesticide.  Examples could be temperature
        extremes, excessive moisture or humidity, heat, sunlight,
        friction, or contaminating substances or media.
    
    2.  Physical requirements of storage which might adversely
        affect the container of the product and its ability to
        continue to function properly.  Requirements might include
        positioning of the container in storage, storage or damage
        due to stacking, penetration of moisture, and ability to
        withstand shock or friction.
    
    3.  Specifications for handling the pesticide container,
        including movement of container within the storage area,
        proper opening and closing procedures (particularly for
        opened containers), and measures to minimize exposure
        while opening or closing container.
    

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    4.  Instructions on what to do if the container is damaged in
        any way, or if the pesticide is leaking or has been
        spilled, and precautions to minimize exposure if damage occurs
    
    5.  General precautions concerning locked storage, storage in
        original container only, and separation of pesticides
        during storage to prevent cross-contamination of other
        pesticides, fertilizer, food, and feed.
    
    6.  General storage instructions for household products should
        emphasize storage in original container and placement in
        locked storage areas.
    
    B.  Pesticide Disposal Instructions;
    
    The label of all products, except those intended solely for
    domestic use, must bear explicit instructions about pesticide
    disposal.  The statements listed below contain the exact wording
    that must appear on the label of these products:
    
    1.  The labels of all products, except domestic use, must
        contain the statement, "Do not contaminate water, food,
        or feed by storage or disposal."
    
    2.  Except those products intended solely for domestic use,
        the labels of all products that contain active ingredients
        appearing on the "Acutely Hazardous" Commercial Pesticide
        Products List (RCRA "E" List) at the end of this appendix
        or are assigned to Toxicity Category I on the basis of
        oral or dermal toxicity, skin or eye irritation potential,
        or Toxicity Category I or II on the basis of acute inhala-
        tion toxicity must bear the following pesticide disposal
        statement:
    
        "Pesticide wastes are acutely hazardous.  Improper dis-
        posal of excess pesticide, spray mixture, or rinsate is
        a violation of Federal Law.  If these wastes cannot be
        disposed of by use according to label instructions,
        contact your State Pesticide or Environmental Control
        Agency, or the Hazardous Waste representative at the
        nearest EPA Regional Office for guidance."
    
        The labels of all products, except those intended for
        domestic use, containing active or inert ingredients
        that appear on the "Toxic" Commercial Pesticide Products
        List (RCRA "F" List) at the end of this appendix or
        presently meet any of the criteria in Subpart C, 40 CFR
        261 for a hazardous waste must bear the following pesticide
        disposal statement:
    

    -------
        "Pesticide wastes are toxic.  Improper disposal of excess
        pesticide, spray mixture, or rinsate is a violation of
        Federal Law.  If these wastes cannot be disposed of by
        use according to label instructions, contact your State
        Pesticide or Environmental Control Agency, or the Hazardous
        Waste representative at the nearest EPA Regional Office
        for guidance."
    
        Labels for all other products, except those intended for
        domestic use, must bear the following pesticide disposal
        statement:
    
        "Wastes resulting from the use of this product may be
        disposed of on site or at an approved waste disposal
        facility."
    
    3.  Products intended for domestic use only must bear the
        following disposal statement:  "Securely wrap original
        container in several layers of newspaper and discard in
        trash."
    
    C.  Container Disposal Instructions
    
        The label of each product must bear container disposal
        instructions appropriate to the type of container.
    
        1.  All products intended for domestic use must bear one
            of the following container disposal statements:
    Container Type
                    Statement
    Non-aerosol products
    (bottles, cans, jars)
    Non-aerosol products
    (bags)
    Aerosol products
    Do not reuse container (bottle, can, jar).
    Rinse thoroughly before discarding in trash.
    Do not reuse bag. Discard bag in trash.
    Replace cap and discard containers in
    trash. Do not incinerate or puncture.
        2.  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
    other 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.	
    

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    Container Type
    Statement
    Fiber drums
    with liners
    Paper and
    plastic bags
    Compressed gas
    cylinders
    Completely empty liner by shaking and
    tapping sides and bottom to loosen clinging
    particles. Empty residue into application
    equipment. Then dispose of liner in a
    sanitary landfill or by incineration if
    allowed by state and local authorities.
    If drum is contaminated and cannot be
    reused^, dispose of in the same manner.
    Completely empty bag into application
    equipment. Then dispose of empty bag in
    a sanitary landfill or by incineration,
    or, if allowed by State and local
    authorities, by burning. If burned, stay
    out of smoke.
    Return empty cylinder for reuse (or
    similar wording).
        ^Manufacturer 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.
    

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

    -------
          "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)
    Tetraethyl pyrophosphate
    Thallium sulfate
    Thiofanbx
    Toxaphene
    Warfarin
    Zinc phosphide
    There are currently no inert ingredients for commercial pesticides
    on the "Acutely Hazardous" List (RCRA "E" List).
    

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            "Toxic" Commercial Pesticide Products (RCRA "F" List)
                             Active Ingredients;
    
    Acetone
    Acrylonitrile
    Amitrole
    Benzene
    Bis(2-ethylhexyl)pthalate
    Cacodylic acid
    Carbon tetrachloride
    Chloral (hydrate)
    Chlordane (technical)
    Chlorobenzene
    4-Chloro-m-cresol
    Chloroform
    o-Chlorophenol
    4-Chloro-o-toluidine hydrochloride
    Creosote
    Cresylic acid
    Cyclohexane
    Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c ,d ]-pentalen-2-one
        (kepone, chlordecone)
    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-(l,l-dimethyl-2-propynyl) benzamide  (pronamide,Kerb)
    Dichloro diphenyl dichloroethane  (ODD)
    Dichloro diphenyl trichloroethane (DDT)
    Dichlorethyl ether
    2,4-Dichlorophenoxyacetic, esters and salts  (2,4-D)
    1,2-Dichloropropane
    1,3-Dichloropropane (Telone)
    Dimethyl phthalate
    Ethyl acetate
    Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
    Ethylene dibromide (EDB)
    Ethylene dichloride
    Ethylene oxide
    Formaldehyde
    Furfural
    Hexachlorobenzene
    Hexachlorocyclopentadiene
    Hexachloroethane
    Hydrofluoric acid
    

    -------
            "Toxic" Commercial Pesticide Products  (RCRA "F" List)
                             Active Ingredients;
    
    Isobutyl alcohol
    Lead acetate
    Lindane
    Maleic hydrazide
    Mercury
    Methyl alcohol
    Methyl bromide
    Methyl chloride
    2,2'-Methylenebis (3,4,6-trichlorophenol)   (hexachlorophene)
    Methylene chloride
    Methyl ethyl ketone
    4-Methyl-2-pentanone (methyl isobutyl ketone)
    Naphthalene
    Nitrobenzene
    p-Nitrophenol
    Pentachloroethane
    Pentachloronitrobenzene  (PCNB)
    Pentaclorophenol
    Phenol
    Phosphorodithioic acid, 0,0-diethyl, methyl ester
    Propylene dichloride
    Pyridine
    Resorcinol
    Safrole
    Selenium disulfide
    Silvex
    1,2,4,5-Tetrachlorobenzene
    1,1,2,2-Tetrachloroethane
    Tetrachloroethylene
    2,3,4,6-Tetrachlorophenol
    Thiram
    Toluene
    1,1,1-Trichloroethane
    Trichloroethylene
    Trichloromonofluoromethane  (Freon 11 )
    2,4,5-Trichlorophenol
    2,4,6-Trichlorophenol
    2,4,5-Trichlorophenoxyacetic acid  (2,4,5-T)
    Xylene
    

    -------
    "Toxic" Commercial Pesticide Products (RCRA "F" List)
     Inert Ingredients;
    Acetone
    Acetonitrile
    Acetophenone
    Acrylic acid
    Aniline
    Benzene
    Chlorobenzene
    Chloroform
    Cyclohexane
    Cyclohexanone
    Dichlorodifluoromethane (Freon 12 )
    Diethyl phthalate
    Dimethylamine
    Dimethyl phthalate
    1,4-Dioxane
    Ethylene oxide
    Formaldehyde
    Formic acid
    Isobutyl alcohol
    Meleic anhydride
    Methyl alcohol (methanol)
    Methyl ethyl ketone
    Methyl methacrylate
    Naphthalene
    Saccharin and salts
    Thiourea
    Toluene
    1,1,1-Trichloroethane
    1,1,2-Trichloroethane
    Trichlorofluoromethane (Freon 11®)
    Vinyl chloride
    Xylene
    

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                          EPA Index co Pesticide Chemicals  •
    
                                     AMITHOLE*
    
    TYPE PESTICIDE;  Herbicide
    
    FORMULATIONS;  Tech (902, 95?); WP (152, 252); ?1C (0.33 Ib/gal, 12);
    SC/L (0.3 Ib/gal, 2 Ib/gal); SC/S (502, 902); PrL (0.362, 12)
    
    CE^RAL WARNINGS AMD LIMITATIONS:  For use as general weed killer in non-
    crop areas.  Do not allow spray or spray drifc co contaminate edible
    crops, or water which will be used for irrigation, drinking or other do-
    mestic purposes.  Do not apply to water where fish are present.  No resi-
    due in crops is permitted.  Soil persistence:  2 to 4 weeks.
    
    TIME REQUIRED FOR CONTROL:  Ten days to 3 weeks.
    
    PHYTOTOXICITY TO TARGET WEEDS:  Albinism in developing foliage; senescence
    in mature leaves, wilting.
    
    PHYTOTOXICITY TO CROPS;  Not 1'ocated.
    
    MODE OF ACTION:  Disrupts chioroplast development; inhibits regrowth from
    buds; general growth inhibition; interferes with metabolism of nucleic
    acid precursors.
    CQBIBE
    3FAV3B
    ADABBA
    AZALAA
    AZAAAC
    3FATAA
    ZLAOAA
    :QAA,«
    3FDQAA
    AZA033
    3FDHAA
    IAAKAA
    :
    -------
                                      EPA Index to Pesticide Chemicals
    
                                                  A.MITROLE
    
              '  3ROADLZAF ME2DS CONTROLLED  (continued)
    
    PA.HAAA3       milkweed                              (a)
    PSGAAA3       morninggLory
    P3FAJ3N       mugworc
    P9KAAAC       mustard
    PFFARAA       pennywort
    PAAAABI       pigweed                               (a)
    PDXASAA       plantain
    PFMAFB3       puncturevine
    PAAAA3P       purslane
    P3FAZAA       ragweed
    ?BI
    -------
                                       EPA Index to Pesticide Chemicals
    
                                                   A.MI1ROLE
    
                 GRASSES AKD OTHER MONOCOTS CONTROLLED (continued)
    
     PCACI3C       witchgrass
    
                     (a) at 2 pounds active ingredient per acre.
                     (b) at 4 pounds active ingredient per acre.
                     (d) at 8 pounds active ingredient per acre.
                     (1) suppression only.
     PDMACAA
     PBWAFBS
     PACABBC
     PAYAE3C
     PELAPAA
    . PAYACAA
     PCQBPSA
     PCQBQAA
     PBWAFCN
     PAHABBI
     PAHA3BJ
     PENAC3A
     PELATBL
     PAHA3AA
    .PELAT30
     PDMAC3A
     PSWAF3B
    PFDABAA
    PCACJAA
    PAAAACt
    PECA3BA
     WOODY  PLANTS  CONTROLLED;
    
      ash
      bear oak
      bigleai maple
      buckbrush
      cherry
      honeysuckle
      kudzu
      locust
      northern red oak
      poison ivy
      poison oak
      pricklyash
      salnonberry
      sumac
      western dewberry
      white ash
      white oak
     (f)
    (g)
    (g)
    (f)
    (b)
    (e)
    (e)
    (f)
    (g)
    (f)
    (g)
    (h)
    (h)
                    (e) at 2 pounds active ingredient per 100 gallons.
                    (f) at 3 pounds active ingredient per 100 gallons,
                    (g) at 4 pounds active ingredient per 100 gallons.
                    (h) at 6 pounds active ingredient per 100 gallons.
    AQUATIC WEEPS CONTROLLZ3:
    
      cattail
      phragmites
      tules
      waterhvacinth
    (k)
    
    (i)
                    (i) at 1 to 1.5 pounds active ingredient per acre.
                    (j) at 6 to 10 pounds active ingredient per acre.
                    (k) at 8 to 20 pounds active ingredient per acre.
                NONFLOMERISG PIJUNTS CONTROLLED: '
    
    PSTA3BC       scouringrush                         (=)
    
                    (c)  a: 6 pounds active ingredient per acre.
    
                Issued:   12-01-31               1-00^401-3
    

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               Sice, Dosage
               and Fomulaeion
               (la a.i./A)
    
               AGRICULTURAL PREMISES
    
    660000A      Uncultivated Agricul-
                  cural Areas
                                    EPA  Index  Co  Pesticide  Chemicals
    
                                                AMITROL2
    
                                       Tolerance,  Use, Limieaeions
                                       General Information;  Unculcivaced agricultural
                                       areas include farm buildings,  fencerows,  storage
                                       areas,  etc.
                   1.SO-5.M)
                   (50-90" SC/S)
    
                   2.00-8.00
                   (2 Ib/gal SC/L)
                   2.00-6.00 lb/
                    100 gal
                   (2 Ib/gal SC/L)
                   (50-902 SC/S)
                                       Broadcast or spot treatment.  Apply in enough
                                       water for adequate coverage; double che spray vol-
                                       ume in Che interaountairi states.   The specific
                                       dosage is determined by the weeds to be con-
                                       trolled.   May be tank mixed with  atrazine;  or
                                       diuron; or simazine.
    
                                       Woody plant control.  Broadcast or spot treatment.
                                       Thoroughly spray all foliage and  stems to the
                                       ground line from the time the foliage is fully
                                       developed until plants begin to go dormant.
               ORNAMENTALS
    2514UA
    25019AA
    25021AA
    25021DA
     302 6AA
     5025DA
        *
     5040AA
     •ioQSAA
     -0-3AA
     50&AAA
     5G
    -------
                                     SPA Index co Pesticide  Chemicals
    3509OAA
    35090DA
    
    34102AA
    3il02DA
    
    35106AA
    35106DA
    
    35107AA
    35107DA
    
    351I3AA
    351130A
    
    33211AA
    35119AA
    34L37AA
    34137DA
    
    35227AA
    35127AA
    25127DA
    
    35130AA
    35130DA
    35000DA
               Sice, Dosage
               and Fonnulation
               (Ib a.i./A)
                                                AM1TROLZ
    
                                       Tolerance,  Use, Limitations
                 American Beech cluster (continued)
    
                 Norway Spruce
                 Norway Spruce
                  (nursery stock)
                 Oleander       ~
                 Oleander (nurserv
                 Red Pine
                 Red Pine (nursery
                  stock)
                 Red Spruce
                 Red Spruce (nursery
                .  stoeic)
                 Scotch Pine
                 Scotch Pine (nursery
                  stoeic)
                 Silver Maple
                 Sycamore
                 Viburnum
                 Viburnum (nursery
                  scock)       """
                 White Ash  =r~
                 White Soruce
                 White Spruce (nursery
                  scock)
                 Yew
                 Yew (nurserv scock)
                   0.90-1.05
                   (902 SC/S)
                   (2 Ib/gal SC/L)
                   (is:
                                       Directed spray.  Apply to small weeds in spring or
                                       early summer in 80 to 100 gallons of water, to wee
                                       _the foliage thoroughly.  Cut or mow tall weeds to
                                       the ground line, remove cuttings and spray re-
                                       growth 1 or 2 weeks later.  Reapply when any re-
                                       growth is 6 to 12 inches tall.   May be tank mixed
                                       wicn simazine.
                                       May be formulated with simazine.
                 Ornamental Hardwoods
                  (nursery stock)
    
                   3.00-8.13
                   (2 Ib/gal SC/L)
                   (50-90S SC/S)
                                       D.irected spray for chrysanthemum control.   Apply
                                       in 100 gallons water when weeds are ^ to 6 inches
                                       tall.   Keep spray off hardwood stock.
               Issued:  12-01-31
                                               1-004^01-5
    

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               Sire, Dosage
               and "oroulation
               (Ib a.i./A)
    
    33010AA      Ornamental Lavns
    
                   •»•»
                   (0.36-12 PrL)
                   0.53 Ib a.i./
                    5,000 sq.ft
                   (2 ib/gal SC/L)
    32000AA      Ornamencal Planes
    
                   0.90
                   (902 SC/S)
    32000DA      Ornamental Planes
                 Tnursery stock.)
    
                   0.90
                   (90Z SC/S)
    EPA Index Co Pesticide Chemicals
    
                AMITROLZ
    
      Tolerance, Use,  Limitations
      Spec  CreaCment  Co  individual weed  clumps.   Spray
      target weeds only.  Dig up  created quackgrass  co  a
      depth of  1  Co 6 inches 2 weeks  afcer  application.
    
      Lawn  renovation.   Apply in  late summer  co  early
      fall when planes are actively growing in 25 co 30
      gallons of  water.  Water heavily if no  rain falls
      within 3  to 7 days.  Dig, rotovate or plow 10  co
      14 days after application and reseed.   Keep spray
      off desirable vegetation.
      Directed  spray.  Apply  co weeds  in  plantings  in-
      median scrips.  Tank mix with sinasine.  Where
      johnsongrass or bermudagrass is  a problem, may  be
      cank mixed with diurbn; or monuron.
      Directed  spray.  Tank mix with  simazine.
               RIGHTS -OF -i
    i'OUOA      Right s-o f-Vay
    
                   1.80-5.40
                   (50-90: SC/S)
    
                   2.00-8.00
                   (2 Ib/gal SC/L)
      .'Broadcast or spot  treatment.  Apply in enough
      water for adequate coverage; double Che spray vol-
      ume  in tne  ineermountain states.  Tne spcefic dos-
      age  is decermerid by  cne weeds to be controlled.
      May  be Cank mixed with acrazine; bromacil; diuron;
      monuron; simazine; atrazine ana sodium 2,3,o-tri-
      chlorophenylacetate; bromacil and 2,<*-dichloro-
      phenoxyacetic acid esters or amines; bromacii and
      diuron; bromacil and sodium 2,3,6-trichloro-
      phenylacetate; or bromacil and diuron and 2,4-di-
      cfalorophenoxyacetic acid esters or amines.
               Issued:   12-01-31
              1-004401-6
    

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               Sice,  Dosage
               and Formulation
               (Ib a.i./A)
                       EPA  Index  to Pesticide Chemicals
    
                                   AMITROLE
    
                          Tolerance,  Use,  Limitations
                 Rights-of-Vay (continued)
                   1.00-2.00
                   (252 WP)
                          broadcast or spot creacnent.   Apply in 20 Co 100
                          gallons of water.  Use the higher dosage for pro-
                          longed control or when weeds  are 6 to 3 inches
                          tall.
                          Formulated with linuron.
                   l.i9-2.97
                   (0.33 Ib/gal F1C)
    670110A
      2.00-6.00 Ib/
       100 gal
      (2 Ib/gal SC/L)
      (50-902 SC/S)
    
    Paved Areas
    
      1.98-2.97
      (0.113 Ib/gal F1C)
    Broadcast or spoc treatment.  Apply in 100 gallons
    of water.  Use the lower dosage where annual rain-
    fall is less than 15 inches and the higher dosage
    where annual rainfall is between 15 to 20 inches.
    Formulated with ammonium 2,3,6-trichiorophenyl-
    acetate and atrarine.
    
    Woody plant control.  Broadcast or spot treatment.'
    Thoroughly spray all foliage and stems to the
    ground line from the time the foliage is fully
    developed uncii planes begin co go dormanc.
                                       Prepaving treatment.  Destroy existing weed
                                       growth, grade and level area to be surfaced.
                                       Apply in at least 300 gallons of water per acre.
                                       Apply asphalt or cement cover as soon as possible.
                                       Formulated with ammonium 2,3,6-trichlorophenyl-
                                       acetate and atrazine.
               COMMERCIAL AND INDUSTRIAL PREMISES
    jTOCOOA      N'oncroa Areas
                   1.30-5.40
                   (50-902 SC/S)
    
                   2.00-4.00
                   (2 Ib/gal SC/L)
                          General Information:
                          ing lots,  tank farms
                          fencerows, etc.
                                                             Noncrop areas include park-
                                                             lumber yards, storage areas,
                          Broadcast or spot treatment.  Apply in enough
                          water for adequate coverage; double the spray vol-
                          ume in the intermountain states.   The specfic dos-
                          age is determined by the weeds to be controlled.
                          May be tank mixed with atrazine;  bromacil; diuron;
                          karbutilate; monuron; simazine; atrazine and
                          sodium 2,3,6-trichlorophenylacecate; bromacil and
                          2,4-dichlorophenoxyacetic acid esters or amines;
                          or bromacil and sodium 2, j, 6-crichlorophenyi-
                          acetate.
               Issued:   12-01-31
                                  1-004401-7
    

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      iTOHOA
                 Sice, Dosage
                 and Formulation
                 (lb a.i./A)
                          EPA Index co Pesticide Chemicals
    
                                      AMITROLS
    
                            Tolerance, Use, Limitations
                   Noncrop Areas (continued)
                     1.49-2.97
                     (0.33 Ib/gal rlC)
                     3.96
                     (0.44 Ib/gal F1C)
                     0.90-3.00
                     (0.3 Ib/gal SC/L)
        2.00-6.00 lb/
         100 gal
        (2 ib/gal SC/L)
        (50-902 SC/S)
    
      Payed Areas
    
        1.98-2.97
        (0.33 Ib/gal F1C)
                            Broadcast or spoc treatment.  Apply in 100 gallons
                            of water.  Use the lover dosage where annual rain-
                            fall is less Chan 13 inches and the higher dosage
                            where annual rainfall is between 15 Co 20 inches.
                            Formulated with ammonium 2,3,6-trichlorophenyl-
                            acetate and aerazine.
                            Broadcast or spoc treatment.
                            gallons of water.
                            Formulated with simazine. '
                                  Apply in ac lease 50
    Broadcast or spoc treatment.  Apply in 20 Co 100
    gallons of water.
    Formulated with dimethylamine brooacil and
    dime thy lamine 2,3,6-Cri'chlorophenylacecace.
    
    Woody plane control.  Broadcast or spot treatment.
    Thoroughly spray all foliage and seems to che
    ground line from che time che foliage is fully
    developed uncil planes begin eo go dormant.
                                         ?r«paving treatment.  Descroy existing weed
                                         growth, grade and level area co be surfaced.
                                         Apply in ac lease 300 gallons of wacer per acre.
                                         Apply asphalt or cement cover as soon as possible.
                                         Formulated with ammonium 2,3,6-trichlorophenyl-
                                         acetate and aerazine.
    _. rTOOOOA
    DOMESTIC DWELLINGS, MEDICAL FACILITIES AND SCHOOLS
    
      Noncroo Areas
                     (0.36-15 PrL)
                     1  pt product/
                      1-2 gal
                            General Information;  Noncrop areas include areas
                            along walks, fencerows, buildings, pacios, and
                            driveways, etc.
    
                            Spot treacmenc co individual weeds.  Spray target
                            weeds only.  Dig up created quackgrass to a deptn
                            of 5 to 6 inches 2 weeks after application.
                                 *
                            Spot treatment.  Apply using a sprayer or watering
                            can.
                 Issued:  12-01-81
                                    1-004401-3
    

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                                     EPA Index  Co  Pesticide  Chemicals
                                                 AMITROLZ
               Sice, Dosage
               and Formulation
               (Ib a.i./A)
                   (12 EC)
                            Tolerance, Use, Limitations
               FOREST, CHAPARRAL. NONAGRICULTURAL AND WASTELANDS
    
    30126AA      American Seech
    3012"AA      American Elm
    30119AA      Arborvitae
    3012SAA      Balsam Fir
    30039AA      Douglas-Fir
    30077AA      Eastern Hemlock
    30129AA      Fraser Fir
    30050AA      Juniper
    30130AA      Norway Spruce
    30103AA      Red Pine
    30125AA      Red Spruce
    30113AA      Scotch Pine
    30131AA      Silver Maple
    30066AA      Svcamore
    30132AA      Vhite Ash.
    •30108AA      White Spruce
    30073AA      Yew
                   0.90-1.05
                   (902 SC/S) '
                   (2 Ib/gal SC/L)
                   (152 WP)
                            Directed spray in forest plantations.. Apply to
                            small weeds in spring or early summer in 80 to 100
                            gallons of water, to wet the foliage  thoroughly.
                            Cut or mow tall weeds to tfce ground line, remove
                            cuttings and spray regrowth 1 or 2 weeks later.
                            Reapply when any regrowth is 6 to 12  inches tall.
                            May be tank mixed with siiaazine.
                            Mav be formulated with simazine.
    :5012MB
    ;5033MB
    AQUATIC AREAS
    
    General Warnings and Limitations:  Do not allow spray or drift to contami-
    nate water which will be used for irrigation, drinking or other domestic
    purposes.  Do not apply to water where fish are present.
    
      (Moving Water)
    
      Drainage Canals
      Drainage Ditches
      Marshes
                   6.00
                   (2 ib/gal SC/L)
                            Cattail control in North Central and Eastern
                            States.  Broadcast after catkins are fully devel-
                            oped until frost.  Do not disturb treated plants.
                            Spot treat any regrowth.  Apply in 300 gallons o:
                            water by ground and in  10 gallons of water by
                            aerial eauioment.
               Issued:  12-01-81
                                    1-004401-9
    

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    Size,  Dosage
    and Formulation
    (Ib a.i./'A)
                     EPA  Index  to Pesticide Chemicals
    
                                 AMITROLS
    
                        Tolerance,  Pse,  Limitations
      Drainage Canals cluster (continued)  ,
        8.00-10.00
        (2 ib/gal SC/L)
                        Cattail control in Southwestern and Western
                        States.  Broadcast after catkins are fully devel-
                        oped until frost.  Do not disturb created plants.
                        Spot treat any regrowen.  Apply the lower dosage
                        in 400 gallons of water by ground and the higher
                        dosage in 15 gallons of water by aerial equipment.
    
                        Cattail control. 'Broadcast after catkins are
                        fully developed until frost.  Do not disturb
                        treated plants.  Spot treat any regrowth.  Apply
                        in 300 to 400 gallons of water by ground and in
                        15 gallons of water by aerial equipment.
    
                        Cattail,  phragmites and tules control.  Broadcast.
                        Use the higher dosage in flooded sites and the
                        lower dosage in nonflooded sites.  Tan* mix with
                        sodium dalapon.
    
                        Phragmites control in North Central and Eastern
                        States.  Broadcast after plants are 30 inches tall
                        until early fruiting stage.  Apply in 100 gallons
                        of water by ground and in 5 to 10 gallons of water
                        by aerial equipment.
    
                        Phragmites control in the Atlantic coast region.
                        Broadcast after plants are 30 incnes tall until
                        early fruiting stage.  Apply the lower dosage in
                        300 gallons of water by ground and in 5 gallons of
                        water by aerial equipment to nonflooded sites.
                        Apply the higher dosage in 300 gallons of water by
                        aerial equipment to flooded sites.
    
    1.00-1.50           Wacerhyacinch control in the Southeastern States.
    (2 Ib/gal SC/L)     Broadcast in April to wet tne weeds and the shoots
                        under the plants thoroughly.  Apply in 200 gallons
                        of water by ground and in 5 gallons of water by
                        aerial equipment.
        7.20-9.90
        (90S SC/S)
        1.80-4.50
        (902 SC/S)
        8.00
        (2 Ib/gal SC/L)
        15.&0-2Q.OO
        (2 Ib/gal SC/'L)
      Drainage.Ditches
                        See Drainage Canals cluster.
      (Marshes, Estuaries, Sh'orelines)
    
      Marsnes               See (Moving Water), Drainage Canals cluster.
    
      (Adjacent eo Water)
    
      Di:;h 3anks           See (Moving Water), Drainage Canals cluster.
    
    Issued:  12-01-31               1-004401-10
    

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                Site,  Dosage
                and  Formulaeion
                (Ib  a.i./AJ
                        EPA  Index  to  Pesticide Chemicals
    
                                   AMITROL2
    
                          Tolerance,  Use, Limitations
               AERIAL AND TANK MIX APPLICATIONS
    '001500
    Aerial Applicaeions
    •900300
    Tank Mix
                                        Refer Co
    
                                        AQUATIC  AREAS
                                        All  sices
                                        Refer  Co
    
                                        AGRICULTURAL  PREMISES
                                        All  sices   .
    
                                        ORNAiMENTALS
                                        American Beech  cluscer,  Oroaraencal  Planes,'Orna-
                                        mental Planes (nursery stock)
    
                                        RIGHTS-OF-WAY
                                        Righcs-of-Way
    
                                        COMMERCIAL AND  INDUSTRIAL PREMISES
                                        Noncrop Agricultural Areas
    
                                        FOREST, CHAPARRAL.  NONAGRICULTURAL  AND WASTELAND
                                        All  sites
    
                                        AQUATIC AREAS
                                        All  sices
                Issued:   12-01-31
                                  1-004401-11
    

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                          EPA  Index  co  Pesticide Chemicals
    
                                     AMITROLE
    
    Listing of Registered Pesticide Produces by Formulation
    
    90* technical chemical
      amitrole (004401)
        000241-00222   000264-00238   002749-00071   00931S-00017
    
    95Z technical chemical
      amitrole (004401)
        007173-00093
    
    15% vee table powder
      amicrole (004401) plus siaazine (080807)
        000264-00124
    
    25* weccable powder
      amicrole (004401)' plus linuron (035506)
        000264-00246
    
    0.33 Ib/gal f lovable concentrate
      amicrole (004401), atrazine (080803) plus ammonium 2,3,6-crichloro-
       phenylacetate (082606)
        000264-00172
    
    0.44 Ib/gal flovable concentrate
      amicrole (004401) plus simazine (080807)
        000264-00196
    
    1* flovable concentrate
      amicrole (004401) plus simazine (080807)
        000264-00156
    
    0.3 Ib/gal soluble concentrate/liquid
      amicrole (004401), dimechylamine bromacil (012304) plus dimetnylamine
       2,3,6-crichlorophenylacecace (082605)
        000254-00244
    
    2 Ib/gal soluble eoncentrace/1 iouid
      amicrole (004401)
        000264-00060   000264-00135   000264-00226   002749-00137
        010337-00005
    
    502 soluble concentrate/solid
      amicrole (004^01)
        000264-00063   002749-00216
    
    902 soluble concentrate/solid
      amicrole (0044Q1)
        000241-00057   000241-00168   000264-00119   002749-00073
        007173-00142   009319-00011
    
    0.35" pressurized liouid
      amicrole (.004401)
        007701-00032
    
    Issued:  12-01-31               1-004401-12
    

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               UNITED STATES
    ENVIRONMENTAL PROTECTION AGENCY
           WASHINGTON, O.C.  20460
    

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