x>EPA
            United StatM
            Environmental Protection
            Agency
            Off ice of
            Pvtticidw tnd Toxic Subttanoat
            Washington DC 20460
                                     September 1985
Guidance for the
Reregistration of
Pesticide Products
Containing Trimethacarb

as the Active Ingredient

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          CASE NUMBER 112

          GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS

             CONTAINING

      AS THE ACTIVE INGREDIENT


            TRIMETHACARB
    ENVIRONMENTAL PROTECTION AGENCY
    OFFICE OF PESTICIDE PROGRAMS

      WASHINGTON, D.C.  20460

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                        TABLE OF CONTENTS


      Introduction 	  1

I.    Regulatory Position and Rationale	4

II.   Requirement for Submission of Generic Data	49

III.  Requirement for Submission of Product-Specific
      Data	*	52

IV.   Submission of Revised Labeling 	 52

      A.  Label Contents	53

      B.  Collateral Information 	 58

V.    Instructions for Submission	59

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                           APPENDICES
                                                              Page
II-l     Guide to Bibliography	62

II-2     Bibliography	64

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

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

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

IV-1       40 CFR 162.10 Labeling Requirements

IV-2       Table of Labeling Requirements

IV-3       Physical/Chemical Hazards Labeling Statement

IV-4       Storage and Disposal Instructions
                                11

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                         INTRODUCTION

     The Federal Insecticide, Fungicide, and Rodentlcide Act
(FIFRA sec. 3(g)) directs EPA to reregister all pesticides as
expedltiously as possible.

     To carry out this task, EPA has established the Regis-
tration Standards program, which will review all pesticide
products containing active ingredients first registered before
January 1, 1977.  Pesticides will be reviewed in use clusters
which have been ranked to give earliest review to pesticides
used on food and feed crops.

     The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient.  EPA's reassessment results in the development
of a regulatory position, contained in a Registration Standard,
on each pesticide and its uses.  The Agency may require the
registrant to modify product labels to provide additional
precautionary statements, restrict the use of the pesticide
to certified applicators, provide reentry intervals, modify
uses or formulation types, specify certain packaging limitations,
or other requirements to assure that proper use of the pesticide
will not result in adverse effects on the environment.

     The scientific review, which is not contained in this
Guidance Package but is available upo'n 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 have serious concerns, we will
address end use products as  part-of the Registration Standards
program and will propose regulatory actions to the extent neces-
sary to protect the public.

     EPA has the authority under FIFRA sec. 3(c)(2)(B) to
require registrants to submit data that will answer our
questions regarding the hazards that may result from the
intended use of a pesticide.  Although sec. 3(c)(2)(B) provides.
that all registrants are responsible for these data, the
Agency generally imposes generic data requirements only o'n  the
registrants of the manufacturing use products  (basic suppliers

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of the active ingredient) and other producers who do not
qualify for the formulator's exemption.*

     A producer who wishes to qualify for the formulator's
exemption may change his source of supply to a registered
source, provided the source does not share ownership in
common with the registrant's firm.  A registrant may do so
by submitting a new Confidential Statement of Formula, EPA
Form 8570-4, identifying the registered source of the active
ingredient, to the appropriate Product Manager within 90
days of receipt of this Guidance Document.  The chart on the
following page shows what is generally required of those who
do and do not qualify for the formulator's exemption in the
Registration Standards program.

     If you decide to request the Agency to cancel the regis-
tration of any of your products subject to the requirements
of this Guidance Document, please notify the Product Manager
named in the cover letter, within 90 days from the receipt
of this document.  If you decide to maintain your product
reglstratlon(s), you must provide the information described in
the following pages within the timeframes outlined. EPA will
issue a notice of intent to suspend the registration of any
currently registered product which does not comply with the
requirements set forth in this Guidance Document.

    You are reminded that FIFRA sec. 6(a)(2) requires you 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.
•The formulator's  exemption applies  to a  registrant of an
product if the source of his active  ingredient(s) :• (1) is a
registered product and  (2) is purchased from a  source which
does not have ownership in common with the  registrant's
firm.

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

   A. Single Active Ingredient
      Products*
These products must be reregis-
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
   B. Multiple Active Ingredient
      Products
These products 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 Pormulator'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 ASSESSMENT
A.  INTRODUCTION
     This chapter contains the Agency's regulatory position and
rationale on products containing the pesticide trimethacarb as
a sole active Ingredient.  The Agency bases its position and
rationale on a consideration of all uses of trimethacarb appearing
on pesticide products registered under Sections 3 and 2U(c) of
PIPRA as well as on products authorized for distribution in
intrastate commerce under 40 CPR §162.17.  The Agency has reviewed
the known chemical, environmental, and toxlcological characteristics
of this pesticide and its established tolerances for residues in
or on corn.  Based on this Information, the Agency has established
data and labeling requirements that must be met by registrants
and applicants for registration of trimethacarb manufacturing-use
products (MPs) in order  for their products to be registered or
reregistered under this  Standard.  Unique  labeling requirements
and certain data needs for end-use products (EPs) containing
trimethacarb are also established by this  Standard.
     Only those data and labeling requirements for current MPs
and EPs  and substantially similar ones registered in the future
are addressed here.  Applications to register products that
differ appreciably from  those  described  in this Standard may  be
subject  to additional data and/or labeling requirements.

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   B. DESCRIPTION OF CHEMICAL AND USE PROFILE
     Trlmethacarb Is the American National Standard Institute's
(ANSI) approved name for an insecticide composed of two isomers
that Is produced by Union Carbide Agricultural Products Company.

     The chemical name for trlmethacarb is 3,4,5-trlmethylphenyl
methylcarbamate and 2,3,5-trimethylphenyl methylcarbamate. Other
names Include the names Broot®, Landrin® and code names UC 27867
and QMS 597.
     Other Identifying characteristics and codes are:
          Empirical Formula:          C11H15N02
          Molecular Weight:           193.24
          CAS Registry Numbers:       2686-99-9 (3,1,5-isomer)
                                      3971-89-9 (2,3,5-isomer)
          Shaughnessy Numbers:        102401 (3t4 ,5-lsomer)
                                      102402 (2,3,5-isoraer)

     Technical trimethacarb is a buff to brown crystalline
powder with a mild ester odor.  The melting point is 105-11^ °C.
Trimethacarb is soluble in water to 58 ppm at 23 °C and
hydrolyzes to trimethylphenol's, C02, and methylamine at pH values
greater than pH 8.
     Union Carbide Agricultural Products Company is the sole
producer qf trimethacarb and markets two" EPs under  the trade name
Broot®.  These are a 15% granular formulation and a 50% wettable
powder formulation.  There are no intrastate products.  There are
no federally registered MPs containing trimethacarb.

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     Trimethacarb is registered to control corn rootworra on field
corn and popcorn.  Application Is made once per season at planting.
Tolerances for food/feed items are currently expressed as the
sum of the residues of both isomeric components of trimethacarb
[the sum of 3,1,5 and 2,3,5-trimethacarb] (40 CFR 180.305).

C. REGULATORY POSITION AND RATIONALE
     Based on a review and evaluation of all available data and
other relevant information on trimethacarb, the Agency has made
the following determinations:

     1.  All products containing trimethacarb as a sole active
         ingredient may continue to be registered for sale,
         distribution, reformulation, and use, subject to the
         terms and conditions specified in this Guidance Document.
         Registrants must provide or agree to develop additional
         data, as specified in Tables A, B and C In order to
         maintain existing registrations or to permit new
         registrations.

         Rationale;  Under PIPRA, the Agency normally does not
         cancel or withhold registration simply because data are
         missing or are inadequate (see Sections 3(c)(2)(B) and
         3(c)(7) of the PIPRA).  Rather, Issuance of this Standard
         provides a mechanism for Identifying data needs.  These
         data will be  reviewed and evaluated when they are received
         and the Agency will determine at that time whether they
         will affect the registrations of trimethacarb.

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         The  existing  data  base,  although minimal,  and use history
         do not suggest that there are any hazards  to mixers,
         loaders,  or applicators  who follow label use directions
         and precautions.   According to the Pesticide Incident
         Monitoring System  (PIMS), there have been  no reports of
         human or  domestic  animal incidents.
     2.   The  Agency will not allow any significant  new uses* to
         be granted for trimethacarb until the toxicologlcal and
         residue chemistry  data deficiencies identified in
         Table A have  been  satisfied.
         Rationale; The Agency Is unable to complete a tolerance
         reassessment  of trimethacarb because of residue chemistry
         and toxicology data gaps.  The data requested in Table A
         are needed for EPA to determine an acceptable daily
         Intake (ADI)  level of trimethacarb and its metabolites
         and to reassess the'present tolerances.  (Refer to
         Section G for a discussion of the tolerance reassessment)
* The terminology "significant new use" is defined in 44 PR 27934,
  May 11, 1979.  In the case of a new food or feed use, the
  Agency will generally consider a new use to be significant if it
  would result in an increase in the Theoretical Maximal Residue
  Concentration (TMRC) of greater than 1%.

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    The Agency will not allow any significant new uses until
    the toxicologlcal and residue data have been received,
    evaluated, and the Agency concludes that new uses are
    supportable.

3.  The Agency is requiring environmental fate data to fully
    assess trlmethacarb'a behavior in the environment.
    Pending the submission of crop rotation data; EPA is
    requiring a crop rotation restriction for EP labels
    which only permits planting of crops registered for
    trimethacarb use in trimethacarb treated soils.

    Rationale;  At present, there are no acceptable studies
    available to assess the environmental fate of trimethacarb,
    The existing data are insufficient to characterize
    trimethacarb1s degradation, metabolism, dissipation and
    mobility, including J,ts potential to leach in soils or
    contaminate groundwater.  Trimethacarb is not on  the
    Groundwater Data Call-in List.  Also, there are a lack
    of adequate* accumulation data on trimethacarb residues
    In rotational crops and fish.  Because of insufficient
    crop rotation data, the Agency is. Imposing the crop
    rotation label restriction.
                          8

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The required residue chemistry plant metabolism data
must demonstrate whether residues of certain manufacturing
Impurities may occur In the raw agricultural commodity
as a result of application of trlmethacarb at the registered
maximum application rate.  The specific chemical names
are not Included here because they are considered
Confidential Business Information.
Rationale:  The Agency Is aware that one of  the
manufacturing Impurities present In technical trlmethacarb
was recently classified as a tumorlgen In the Registry
of Toxic Effects of Chemical Substances.  Additionally,
the Agency has recently received a study by  the National
Toxicology Program which suggests that this  same impurity is
an oncogen and mutagen.  The Agency has not  yet formally
reviewed this study.  If, upon review, the Agency concludes
that the chemical is an oncogen, .a determination will be
made as to Its potency and potential human exposure so
that a hazard assessment can be conducted and appropriate
regulatory action can be taken, if necessary.  To insure
that data will be present to evaluate any potential risk,
the Agency is requiring the registrant to submit data
indicating whether  the impurity will be present, and if
so, at what levels in the raw agricultural commodities.

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5.  In order to more fully assess the Impact of trlmethacarb
    on avlan, fish and freshwater Invertebrate species, an
    acute avlan oral toxlclty study, an acute toxlclty
    study on freshwater Invertebrates, and environmental fate
    studies must be conducted and submitted.  Using current
    estimation techniques, no hazard was predicted from the
    use of trlmethacarb to endangered species.  Due to toxlclty
    to cold water fish, labeling cautioning against exposing
    fish Is required.  Refer to section P(d) (l).and(2) for the
    required labeling statements.
    Rationale;  Based on studies available to assess potential
    hazards to avlan and aquatic organisms, technical
    trlmethacarb Is characterized as slightly toxic to birds
    on a dietary basis and moderately to highly toxic on an
    acute oral basis.  Available data are adequate to
    demonstrate that technical trlmethacarb Is highly toxic
    to cold water fish species.  Accordingly, labeling Indicating
    toxlclty to fish, required by 40 CPR 162.10 (h)(2)(11)(B)
    must be added to the label.  There are no available
    data on trlmethacarb's effects on freshwater aquatic
    Invertebrates.  Once the Agency has reviewed the required
    environmental fate data, acute avlan oral toxlclty
    data, and the acute toxiclty data on freshwater Invertebrates,
    the toxlclty of this compound can be reevaluated and an
    exposure assessment can be made to determine the hazard
    potential of trlmethacarb1s use.
                             10

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6.  Studies on trimethacarb's acute, subchronlc, and chronic
    mammalian toxicity must be submitted.  Acute oral toxlclty
    data In the rat and dog place the technical trimethacarb
    in Toxicity Category II.   Acute dermal toxicity data In the
    rabbit place technical trimethacarb in Toxicity
    Category III.
    Rationale;  The existing toxicology data base Is Inadequate
    to characterize trimethacarb's toxicity, except for
    acute oral and dermal effects and subchronic dermal
    effects.  A teratology study in rats, which is considered
    only of supplemental value due to reporting of data
    deficiencies suggests that trimethacarb Is not teratogenic
    at the doses tested.
    When trimethacarb tolerances were originally established, a
    90-day dog and rat feeding studies and a 2-year rat feeding
    study were used to support these tolerances.  Upon
    reevaluatlori, a no observable effect level  (NOEL) could
    not be determined because these data have been found to be
    unacceptable due to study design and reporting of data
    deficiencies.  However, they do not suggest any adverse
    effects.  The existing toxicology data base does not
    Include any studies conducted by Industrial Bio-Test
    Laboratories, Inc.  Additional  acute, subchronic and
    chronic toxicology are needed to support the current
    tolerances and use  levels on corn.
                             II

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     7.  Registrants of MPs and EPs must submit revised labeling
         which Incorporates the label precautions found In Section P,

         Rationale;  The Agency believes that label statements
         prescribed In this Guidance Document should minimize the
         acute hazards to users of -trlmethacarb and to terrestrial
         and aquatic organisms.
         Acute toxlclty data on freshwater fish Indicate that
         precautionary labeling Is required.  This requirement
         Is addressed In Section F.  The required acute toxlclty
         precautionary statements are specified In 40 CPR 162.10.

D.   CRITERIA FOR REGISTRATION UNDER THIS STANDARD
     To conform to this Guidance Document, products must contain
trimethacarb as the sole active Ingredient, bear required labeling,
and conform to the product composition, acute toxiclty limits,
and.use pattern listed in the attached index of the registered
uses.
     The application for registration or reregistration of
manufacturing-use  and end-use products subject to this Guidance
Document must comply with all terms and conditions described in
it, including submission of an up-to-date Confidential Statement
of Formula, certification of ingredients statement, revised
labeling, commitment to fill data gaps on the schedule specified
by the Agency and, when applicable, offer to pay compensation as
required by 3(c)(l)(D) and 3(c)(2)(D) of the Federal  Insecticide,
Fungicide, and Rodentlclde Act (FIFRA), as amended, 7 U.S.C.
                               12

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136(c)(l)(D) and 136(e)(2)(D).  Registrants of end-use products
who qualify for the Pormulator's Exemption must submit five (5)
copies of draft labeling incorporating the unique labeling statements
identified in Section P.

E.   ACCEPTABLE RANGES AND LIMITS
     1.  Product Composition Standard
         To conform to this Guidance Document, manufacturing-use
         products and end-use products must contain trlmethacarb
         as the sole active ingredient.  Each MP and EP formulation
         proposed for registration must be fully described with
         an appropriate certification of limits, stating maximum
         and minimum amounts of the active and intentionally added
         inert ingredients which will be present in products.

     2.  Acute Toxicity Limits
         The Agency will consider registration of technical
         grade, manufacturing-use and end-use products  containing
         trimethacarb, provided that the product labeling bears
         appropriate precautionary  statements for the  acute
         toxlcity category in which each product is placed.  The
         attached index entry lists all  registered  uses (and
         intrastate label uses*) .as well as approved maximum
         application  rates and  frequencies.

 *  Intrastate uses have  not been  reviewed for  acceptability  under
   sec.  3 of the  PIPRA.  Therefore,  these  uses may not  be  added
   to  any product registered  under sec. 3 until  the  supporting
   data have been submitted,  reviewed,  and  found to  be  acceptable.
                                13

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P.   REQUIRED LABELING
     All manufacturing-use and end-use trlmethacarb products must
bear appropriate labeling as specified in 40 CPR 162.10.  In
addition to the above, the following information must appear on
the labeling:
     a.  Ingredient Statement
         The Ingredient statement for MPs and EPs must list the
         active ingredient as:
              Trlmethacarb (3,4,5-trimethylphenyl
              methylcarbamate mixture with 2,3,5 trimethylphenyl
              methylcarbamate approximately 4:1) 	 %.

     b.  Use Pattern Statements
         All MP trimethacarb products must state that they are
         intended for formulation into other manufacturing-use
         products or end-use products for uses accepted by the
         U. S. Environmental Protection Agency.
         A limiting factor will be data that support the use
         pattern.  No use may be included on the label where the
         registrant fails to agree to comply with the data require-
         ments in either Table A or Table B for that use pattern.
         The attached "EPA Index to Registered Pesticides" entry
         summarizes the currently acceptable use for trlmethacarb
         including site of application, target pests, dosage
         rates, restrictions and limitations, and the method and
         frequency of application.
                                14

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c.  Acute Toxicity Precautionary Statements

    Labels for MPs and EPs must bear statements reflecting

    the compound's acute human toxicity.  The acute oral

    toxlcity data are sufficient to categorize the current

    EP formulations as Toxicity Category II.  The required

    precautionary statements associated with this category

    are specified in 40 CPR 162.10.


d.  Environmental Hazards Statements

    1.  The following revised environmental hazard statement

        must appear on all MP labels:


                  "ENVIRONMENTAL HAZARDS

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


    2.  For end-use products revise the existing environmental

        hazards statement must  read:


                  "ENVIRONMENTAL HAZARDS

          This  pesticide  is  toxic to  fish and wildlife.   Do
          not apply directly to  water or wetlands.  Drift  and
          runoff from  treated areas may  be  hazardous-  to  fish
          in neighboring aquatic sites.   Do not  contaminate.
          water by cleaning  of  equipment or disposal  of  waster.
                           15

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     e.  Crop Rotation Statement
         For EPa, the product label must Include the crop rotation
         statement in the use directions:
         "Do not plant crops used for food or feed which are not
         registered for use with trimethacarb in  soils previously
         treated with this chemical."
G.      TOLERANCE REASSESSMENT
        U.S. tolerances for negllble residues of"trimethacarb
        in or on raw agricultural commodities are as follows
        (40 CPR 180.305):

            0.1 ppm in or on corn grain (including field corn and
            popcorn), corn fodder and forage.

        There are no international tolerances or Codex Maximum
        Residue Limits (MRLs) for residues of trimethacarb  in or
        on corn grain or in animal products.

        It is concluded that the plant .metabolism of trimethacarb
        is not adequately described because residues in mature
        corn kernels were not qualitatively and quantitatively
        characterized.  Additional data are necessary to characte-
        rize the distribution and metabolism of trimethacarb in
        the mature corn plant.
                                16

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Although no tolerances exist for residues of trimethacarb
in animal products, the nature of the residue in animals
is adequately understood at this time.  Trimethacarb or
its animal metabolites do not accumulate in edible tissue
of cattle.  In a cattle feeding study, no l^C residues were
detectable in the muscle, fat or kidney of cattle which
were fed radlolabeled trimethacarb.  However, if the
requested plant metabolism data reveal additional metabo-
lites of toxicologlcal concern, the conclusions regarding
the nature of residues in animals may change and additional
animal metabolism data will be required.

The residue analytical methods for enforcement of toler-
ances covering the sum of the residues of 3j^,5- and 2,3,
5-trimethacarb in or on plant commodities are adequate.
However, if the requested plant metabolism data reveal
additional metabolites of toxicological concern or if the
present residue analytical methods will not adequately
determine all conjugated residues of  concern then
submission of additional validated methods for data
collection and tolerance enforcement  will be required.

U.S. tolerances for corn grain, fodder and forage are not
supported by  the available  residue chemistry data.
                       17

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  Additional data required are as follows:

    1.  Data depicting residues in or on mature field corn
       grain harvested 90 days after application according
       to label use directions.

    2.  Residue data are required for corn oil and milled
       products to determine whether or not residues
       concentrate.  (If residues do concentrate in an*
       of the processed products, the registrant is required
       to submit a petition for tolerances.  However, If food
       additive tolerances are necessary and if other required
       residue data demonstrate the presence of any impurities
       that are shown to be oncogenic (see Section C.4., above),
       there will be a conflict with the section 109
       of the Federal Pood, Drug and Cosmetic Act.  This
       section prohibits the establishment of food additive
       tolerances for additives found to be carcinogenic).

    3.  Additional data are required that depict residues in
       or on corn forage, fodder and silage harvested after
       a single at-plantlng application.  A pregrazlng
       interval must be established and a tolerance for
       residues In or on silage must be established.

The chronic toxicology studies used to support these
tolerances (a 90 day dog feeding study, a 2 year rat
feeding study and a 90 day rat feeding study) upon
                    18

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      reevaluation have been found to be inadequate.

      The adequacy of the established tolerances covering residues
      of trimethacarb on or on corn grain,  forage,  and fodder
      cannot be determined at the present time due  to significant
      gaps in residue chemistry and toxicology.  At present,.
      no acceptable toxicology study exists for calculation of
      the acceptable daily intake (ADI)  or provisional acceptable
      daily intake (PAOI).  Until acceptable data are submitted
      no ADI can be calculated.  Data gaps are discussed in
      Table A.
      A permanent tolerance of 0.1 ppm was granted  for corn
      grain which results in a theoretical maximum residue
      contribution (TMRC) of 0.0016 mg/day for a 1.5 kg diet.

U.S. Tolerances
Crop                                     Maximum Residue Limit (PPM)
field corn (grain)                                0.1
popcorn (grain)                                   0.1
corn forage                                       0.1
corn fodder                                       0.1
No Codex, Mexican, or Canadian tolerances exist for
trimethacarb in or on corn.
                                  19

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                 EPA Index to Pesticide Chemicals

                          TRIMETHACARB*
TYPE PESTICIDE;  Insecticide

FORMULATION:
G
WP
(15%)
(50%)
GENERAL WARNINGS AND LIMITATIONS;  Trimethacarb is toxic to fish,
Do not apply directly to water or wetlands.  Drift and runoff
from treated areas may be hazardous to fish in neighboring areas,

TERRESTRIAL FOOD CROP

(Agricultural Crops)

General Warnings and Limitations; Do not plant any food or feed
crop other than those with registered trimethacarb treated soils
Site and Pest
                  Dosages and    Tolerance, Use, Limitations
                  Formulation(s)
Corn (field corn and popcorn)
                                 0.1 ppm corn grain (including
                                 field corn and popcorn) and
                                 corn fodder and forage (such
                                 tolerances to cover the sum
                                 of the residues of both
                                 components)
                                 90-day preharvest interval
                                 through 1.2 ounces per 1,000
                                 feet of row or 1.35 pounds
                                 per acre at 30-inch row
                                 spacing, for soil application
                                 at planting (band).
•Broot
 3,4,5-trimethylphenyl  methylcarbamate and  2,3,5-trime'thylphenyl
 methylcarbamate
                                20

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                 EPA Index to Pesticide Chemicals

                           TRIMETHACARB
Site and Pest
Corn rootworms
 (continued)
Dosages and
Pormulation(s)

1.2 oz/1,000
 ft of row
  or
1-1.31 lb/A
 [30-40 inch
 row -spacing]
(15% G)
  or
0.9-1.2
 oz/1,000 ft
 of row
(50% WP)
  or
0.75-1.35
 lb/A
 [30-40 inch
 row spacing]
(50% WP)
Tolerance, Use, Limitations
Soil application at planting
(band).  Apply a 6 to 8 inch
band over the row.  Incorporate
by applying behind the
covering disc and ahead of
the press wheel.  Apply
wettable powder in a minimum
of 6 to 8 gallons of water
per 13,068 linear feet
(equivalent to 1 acre with
40-inch row spacing).  Amount
applied per acre depends on row
spacing.
                               21

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             EPA Index to Pesticide Chemicals

                       TRIMETHACARB

Listing of Registered Pesticide Products by Formulation

15t granular
  trimethacarb (102401 and 102402)
    00026*4-00381

50% vrettable powder
  trimethacarb (102401 and 102402)
    000264-00382
                            22

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               EPA Index to Pesticide Chemicals
                         TRIMETHACARB
                          Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number
  Corn
    Corn rootworms
  (15* G)
    000264-00381
  (50% WP)
    000264-00382
                              23

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                          TABLE A
         GENERIC DATA REQUIREMENTS FOR CHEMICAL: TRIMETHACARB
Guideline Citation and Test
Name of Test Substance
§158.120 Product Chemistry
Product Identity:
61-2 - Description of Beginning
Materials and Manufacturing
Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-3 — Analytical Methods to Verify
Certified Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-1 - Odor
63-5 - Melting Point
TQAI
TQAI
TQAI
TGAI
TQAI
TQAI
TGAI
TGAI
Guidelines Are Data Footnote
Status Required Number
Yes No
R m r~] 2
R [~] [X]
CR [X] [~] 3
R fiC] IT"] 1
R r] DC]
R n m
R n [x]
R n tx]
Data Must Be
Submitted Within
Time Frames Listed
Below I/
6 Months
12 Months
12 Months
•  •  •  •  •  0  •
                             24

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                TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: TRIMETHACARB
Guideline Citation and
Name of Test
Test Guidelines
Substance Status
Are Data Footnote
Required Number
Yes No
Submitted Within
Time Frames Listed
Below IL
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation constant
63-11 - Octanol/water partition
coefficient
63-12 - pH
63-13 - Stability
Other Requirements:
61- 1
- Submlttal of samples
TOAI
TOAI or PAI
PAI
PAI
PAI
TOAI
TGAI
TOAI, PAI
R
R
R
R
R
R
R
CR
Cx]
m
Cx]
CX]
Cx]
0
n 5
r] 6
T]
n
r~] 5
T] 5
C~] 7
en
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
                   25

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                                                          TABLE A
                                    GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
§158.120 Product Chemistry
   TGAI • Technical Grade of the Active Ingredient;  PAI • Pure Active Ingredient;  R •  Required;  CR = Conditionally Required
   I/ Data must be submitted within the Indicated time frames, which begin on the date of the Guidance Document.  (See
      front cover for the date).
   2/ Details of the manufacturing process Including the relative amounts of beginning materials,  a description of the
      equipment used to produce the product, reaction conditions, the duration of each step of the process,  the purification
      procedures and quality control measures for the unregistered technical must be submitted.
   3/ Five or more representative samples should be analyzed for the amount of active  Ingredient and each Impurity present
      for which a certified limit Is required. Data regarding the accuracy of the methods used to determine  the active
      ingredient and Impurities In the samples of the technical product must be submitted.
   V Qualitative methods to determine trlmethacarb and all Impurities In the technical product are needed.   Each method
      must be accompanied by validation studies of the accuracy of the method.
   5/ The temperature at which the assay was run Is needed.
   6/ The solubility of the technical In polar and non-polar solvents at 20°C or 25°C  must be reported In g/lOOml or rag/kg.
   ?/ Information must be submitted as to the sensitivity of the technical product to  metal Ions and metal.
                                                           26

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                                                        TABLE A
                                        GENERIC DATA REQUIREMENTS FOR CHEMICAL :  TRIMEIHACARB
                                                                                                       Must Additional Data
                                                                                                       Be Submitted Under
                                                                                                       PIPRA § 3(c)(2)(B)?
                                                                                                       Time Frames Por Data
                                                                                                       Submission 2/
Data Requirements
Composition
         Does EPA Have Data
         To Satisfy This
I/       Requirement?  (Yes,
         No, or Partially)
                                                                                     Bibliographic
                                                                                       Citation
§158.125 Residue Chemistry

  171-2 - Chemical Identity

  171-4 - Nature of Residue (Metabolism)

        - Plants
                                             TGAI
                                             PAIRA
                    Yes
                    Partially
        - Livestock


  171-1 - Residue Analytical Method

        - Plant residues
                                          PAIRA and Plant
                                           Metabolites
                    Yes
                                          TGAI and Metabolites  Yes
                                00130616
                                00070071
                                00095891
                                00095892
                                00095893
                                00095928

                                00070071
                                00095928
                                           00070661
                                           00070967
                                           00095900
                                           00095901
                                           00095906
                                           00095907
                                           00095908
                                           00095909
                                           GS0112001
No
Yes 3/  24 Months
                                                                                                        Reserved
                                                   Reserved 5/
                                                         27

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                                                       TABLE A
                                       GENERIC DATA REQUIREMENTS FOR CHEMICAL
                                       TRIMETHACARB
Jata Requirements
Composition
         Does EPA Have Data
         To Satisfy This
I/       Requirement?  (Yes,
         No, or Partially)
Bibliographic
  Citation
 Must Additional Data
 Be Submitted Under
 FEbHA § 3(c)(2)(B)7
 Time Frames For Data
 Submission 2/
158.125 Residue Chemistry - Continued
 171-4 - Magnitude of the Residue-
          Residue Studies for Each
          Pood Use

       - Cereal Grains Group6/

         o Crop - Corn

           — Crop field trials

           — Processed Pood/Feed

           — Meat/Milk/Poultry/Eggs
          Forage, Fodder, and Straw
           of Cereal Grains Group10/

          o Com, forage
                  fodder
                  silage

           — Crop Field Trials
            — Meat/Milk/Poultry/Eggs
    TEP

     EP

TCAI or Plant
    TEP
 1GAI or Plant
  Metabolites
         Partially

         No

         Yes
         Partially


         Yes
00070967
00070662
00070072
00070967
00095900

00070662
00070072
 Yes 7/  42 Months

 Yes 8/  42 Months

 No 9/
Yes ll/  12 Months
No 9/
                                                             28

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                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB

 §158.125 Residue Chemistry - Continued

 I/ Composition:  TGAI = Technical grade of the active Ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP =
    Typical end-use product; EP = End-use product.
 2/ Data must be submitted within the indicated time frames, which begin on the date of the Guidance Document. (See
    front cover for the date).                                                                           .
 3/ Additional metabolism data are required to reflect the distribution and metabolism of ring-labeled LiqCJ3,|lf5- and
    2,3,5-trlmethacarb in mature corn (foliage and grain) following at-planting application.  There is a concern about
    the presence of certain manufacturing Impurities in technical trimethacarb because one of these impurities was
    recently classified as a tumorigen in the Registry of Toxic Effects of Chemical Substances.  The registrant must
    indicate whether residues of this compound and the other compounds listed may result in the in raw agricultural
    commodity as a result' of the maximum registered use.  Refer to CBI attachment for identification of Impurities.
 V If the requested plant metabolism data reveal additional metabolites of toxicologlcal concern, the nature of the
 ~~  residue in animals may change.
 5/ If the requested plant metabolism data reveal additional metabolites of toxicological concern or if the methods
 ~~  will not adequately determine all conjugated residues of concern, then additional validated methods for data
    collection and tolerance enforcement will be required.
 6/ A drop group tolerance is not appropriate at the present time because additional residue data would be required
 ~  for four additional group members (fresh sweet corn, rice, sorghum and wheat).
 II Additional data depicting residues in or on mature field corn grain harvested 90 days after a single at~plantir
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                                                            TABLE A
                                        GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
Data Requirement
           I/     Use  21
Composition     Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?  (Yes, No
or Partially)
Bibliographic
  Citation
Muat Additional Data
Be Submitted Under
PIPHA § 3(c)(2)(B)7
Time Frame for Data
Submission J/
§158.130 Environmental Pate
  DEGRADATION STUDIES-LAB:
  161-1 - Hydrolysis
  Photodegradatlon
  161-2 - In water
TOAI or PAIRA
TQAI or PAIRA
No
No
                    Yes
                    Yes
            9 Months
            9 Months
  METABOLISM STUDIES-LAB;
  162-1 - Aerobic Soil
  162-2 - Anaerobic Soil
TQAI or PAIRA      A
TQAI or PAIRA      A
No
No
                    Yes
                    Yes
           27 Months
           27 Months
  MOBILITY STUDIES;
  163-1 - Leaching and           TQAI or PAIRA
          Adsorptlon/Desorptlon
                             No
                                        Yes
                               12 Months
                                                            30

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                                                        TABLE A
                                      GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
                                                                                                    Must Additional Data
                                                                                                    Be Submitted Under
                                                                                                    FIFRA § 3(c)(2)(B)?
                                                                                                    Time Frame for Data
                                                                                                    Submission V
a Requirement
           I/     Use  2/
Composition     Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?  (Yes, No
or Partially)
Bibliographic
  Citation
j8.130 Environmental Fate - Continued
)ISSIPATION STUDIES-FIELD;

L64-1 - Soil

L64-5 - Soil, Long-term

 ^CUMULATION STUDIES;

165-1 - Rotational Crops
         (Confined)

165-2 - Rotational Crops
         (Field)

165-4 - In Fish
                                  TEP

                                  TEP



                                 PAIRA


                                  TEP


                              TGAI or PAIRA
                  A

                  A
    No

    NO



    NO


    NO


    NO
                    Yes         27 Months

                    Reserved 4/
                                                                     Yes /5
                                39 Months
                                                                     Reserved /6
                                                                     Yes
                                12 Months
                                                                 31

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                                                      TABLE A
                                     GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB


 §158.130 Environmental Pate - Continued

\l Composition:  TCAI = Technical grade of the active Ingredient; PAIRA = Pure active Ingredient,  radlolabelled;
   TEP = Typical end-use product.
21 The use patterns are coded as follows:  A=Terrestrial, Pood Crop; B=Terrestrlal, Non-Pood;  C=Aquatlc, Pood Crop;
   D=Aquatic, Non-Pood; B=Greenhouse, Pood Crop; P=Greenhouse, Non-Pood; G=Porestry; H=Domestlc Outdoor; l=Indoor.
3/ Data must be submitted within the Indicated time frames, which begin on the date  of the Guidance (Document. (See
   front cover for this date).
V Data will be required If soil residues do not reach 50 percent dissipation prior to recommended subsequent
   application to the same site as Indicated by results of 162-1 or 164-1.
5/ For crops rotated on treated areas, any one of the following will apply to preclude a crop rotation restriction:
      (a). A tolerance must be obtained for the rotated crop.
      (b). Data must be provided to determlme time Intervals at which rotated crops planted on treated areas will
           be free of trlmethacarb residues.
6/ Requirement reserved pending results of cqnflned rotational crop studies.
                                                           32

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                                                        TABLE A
                                      GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
Does EPA Have
Data To Satisfy
V Use 21 This Require- Bibliographic
Data Requirement Composition Pattern ment? (Yes, No Citation
or Partially)
§158.135
Toxicology

Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)7
Time Frame for Data
Submission 3/

ACUTE TESTING:
81-1 -
81-2 -

81-3-

81-7 -


Acute Oral Toxlcity - Rat TGAI A Yea
Acute Dermal Toxicity TGAI A Yes
- Rabbit
Acute Inhalation Toxlcity TGAI A No
- Rat
Delayed TGAI A Partial
Neurotoxlclty - Hen

00128130
00128130

-

00051311
00051312
00070659
No
No

Yes 9 Months

Yes V 12 Months


SUBCHRONIC TESTING:

82-1 - 90-Day Feeding :            TGAI
        - Rodent, and
        - Non-rodent (Dog)
82-2 - 21-Day Dermal - Rabbit      TGAI
A


A
No


No


Yes
                               00070656
No  5/


No  5/


No
                                                          33

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                                               TABLE A
                              GENERIC  DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
I/ Use 2/ This Require- Bibliographic FIPRA § 3(c)(2)(B)?
Data Requirement Composition Pattern ment? (Yes, No Citation Time Frame for Data
or Partially) Submission 3/
§158.135
Toxicology - Continued

CHRONIC TESTING:
83-1 -

83-2 -

83-3 -

83-4 -
Chronic Toxlclty - TGAI
2 species:
- Rodent, and A No
- Non-rodent (Dog) A No
Oncogenlclty - TGAI
2 species:
- Rat (preferred), and A No
- Mouse ( preferred}- • • - • A No
Teratogenlclty - TGAI
2 species:
- Rat A Partial
- Rabbit A Partial
Reproduction - Rat TCAI A No
Yes 50 Months
Yes 50 Months
Yes 18 Months
Yes 18 Months
GS01 12020 Yes 6/ 6 Months
GS01 12021 Yes 7/ 6 Months
Yes 39 Months
2-generatlon

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                                                        TABLE A
                                      GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
                                                                                                   Must Additional Data
                                                                                                   Be Submitted Under
                                                                                                   FIFRA § 3(c)(2)(B)7
                                                                                                   Time Frame for Data
                                                                                                   Submission 3/
Data Requirement
           I/     Use  2/
Composition     Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?  (Yes, No
or Partially)
Bibliographic
  Citation
§158.135 Toxicology - Continued
MUTAGENICITY TESTING
84-2 - Gene Nutation (Ames Test)
84-2 - Structural Chromosomal


TGAI A No
TOAI A No


Yes 9 Months
Yes 12 Months
        Aberration

81-4 - Other Genotoxlc Effects    TOAI
                                                               No
                                                                    Yes
                                                    12 Months
SPECIAL TESTING;

85-1- General Metabolism
                                    PAI or PAIRA
                              No
                                        Yes
                                24 Months
                                                          35

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                                                      TABLE A
                                     GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB


§138.135 Toxicology - Continued

V Composition:  PAI = Pure active Ingredient; PAIRA - Pure active Ingredient, radlolabelled; Choice = Choice of several
   test substances determined on a case-by-case basis.
21 The use patterns are coded as follows:  A=Terrestrlal, Pood Crop; B=Terrestrlalt Non-Pood; C=Aqautic, Pood Crop;
~  D=Aquatic, Non-Pood; E=Greenhouse, Pood Crop; F=Greenhouse, Non-Pood; G=Porestry; H=Domestlc Outdoor; I=Indoor.
3/ Data must be submitted within the Indicated time frames, which begin on the date of the Guidance Document. (See
   front cover for this date).
V Although delayed neurotoxlclty studies are not usually required for a carbamate, the unusual observations noted In
   the studies conducted (positive for delayed neurotoxlclty) require an adequate explanation or additional studies to be
   submitted.
5/ This data la not required at this time because Union Carbide Is In the process of conducting chronic feeding studies.
   These studies will be required If the chronic studies are not submitted.
6/ The following data needs to be submitted: . Individual maternal weight data at the Intervals measured and historical
   control data relative to cesarean section :observatIons and fetal malformation and variation observations.  The
   historical data should be presented by Individual study and dated and should cover a period of 2 years prior to
   Initiation of this study and any studies conducted after study termination using the Fischer 3M strain from the same
   vendor.
II This study Is deficient In that not all fetuses were subjected.to skeletal examination after visceral examination
   as reconmeded by the Guidelines. The registrant la, therefore, required to examine those fetuses (which are
   preserved) for skeletal anomalies and submit the data to the Agency.
                                                        36

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                                                          TABLE A
                                       GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMETHACARB
Data Requirement
           V     Use  2/
Composition     Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?  (Yes, No
                                                                                  Bibliographic
                                                                                    Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3/
§158.140
132-1
132-1
133-3
133-1
§158.142
201-1
201-1
Reentry Protection
- Foliar Dissipation
- Soil Dissipation
- Dermal Exposure
- Inhalation Exposure
Spray Drift
- Droplet Size Spectrum
- Drift Field Evaluation

TEP
TEP
TEP
TEP

TEP
TEP

A
A
A
A

A
A

No
No
No
No

No
No

No V
No 4/
No 4/
No V

No 4/
No 4/
I/ Composition: TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrlal, Food Crop; B=Terrestrlal, Non-Food; C=Aquatic, Food Crop;
~  D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestlc Outdoor; I=Indoor.
3/ Data must be submitted within the Indicated time frame, based on the date of the Guidance Document.
V No data are required because trlmethacarb does not meet the criteria described In 40 CFR 158.140 for reentry
   data requirements.
                                                           37

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                                                         TABLE A
                                        GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMBTHACARB
Data Requirement
I/
Composition
Use 21
Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
PIPRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3/
S158.145 Wildlife and
Aquatic
Organisms



AVIAN AND MAMMALIAN TESTING
71-1 -
71-2 -


71-5 -

-

Acute Avian Oral Toxlclty TGAI
Avian Subacute Dietary TGAI
Toxlclty
- Upland Game Bird, and
- Waterfowl
Simulated Field Testing TEP
- Mammals, and
- Birds
Actual Field Testing TEP
- Mammals, and
- Birds
A

A
A
A
A
A
A
No

Yes
Yes
No
No
No
No
Yes

00034769 No
00031769 No
Reserved/4
Reserved/I
Reserved/1
Reserved/4
  AQUATIC ORGANISM TESTING

  72-1 - Freshwater Fish Toxlclty    TGAI
          - Coldwater Fish Species,
            and
          - Wannwater Fish Species

  72-2 - Acute Toxlclty to
          Freshwater Invertebrates
TGAI
A

A
Yes


Yes

No
                                                 GS0144-012


                                                 GS0114-012
                                                                                                                9 Months
No


No

Yes
9 Months
                                                            38

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                                                      TABLE A
                                     GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMBTHACARB

§158.145 Wildlife and Aquatic Organisms - Continued

I/ Composition:  TQAI = Technical grade of the active Ingredient; PAI = pure active Ingredient;
~  TEP = Typical end-use product;
2/ The use patterns are coded as follows:  A=Terrestrlal, Pood Crop; B=Terrestrlalf Non-Pood Crop; C=Aquatlc, Pood Crop;
~  D=Aquatic, Non-Pood; E=Greenhouse, Pood Crop; F=Greenhouse, Non-Pood; G=Porestry; H=Domestlc Outdoor; I=Indoor.
3/ Data must be submitted within the Indicated time frames, which begin on the date of the Guidance Document. (See
~~  front cover for this date).
V  Requirement reserved pending avlan single-dose oral 11)50 data and environmental rate data.
                                                           39

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                                                          TABLE A
                                      GENERIC DATA REQUIREMENTS TOR CHEMICAL TRIMETHACARB
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
I/ Use 2/ This Require- Bibliographic FIFRA § 3(c)(2)(B)?
ta Requirement Composition Pattern ment? (Yes, No Citation Time Frame for Data
or Partially) Submission V
58.150
121-1
Plant Protection
- TARGET AREA EP
pHYTorraxicm
N/A
NO 3/
MONTARGET AREA PHYTOIQXICITY
122-1
122-1
122-2
123-1
123-1
123-2
124-1
124-2
TIER I
- Seed Germination/ TGAI
Seedling Emergence
- Vegetative Vigor TGAI
- Aquatic Plant Growth TGAI
TIER II
- Seed Germination/ TGAI
Seedling Emergence
- Vegetative Vigor TGAI
- Aquatic Plant Growth TGAI
TIER III
- Terrestrial Field TEP
- Aquatic Field TEP
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
No 3/
No 3/
NO 3/
No 3/
No 3/
No 3/
No 3/
No 3/
7Composition:TGAI = Technical grade of the active ingredient;  TEP = Typical end-use product.   EP = End-use product.
/  The use patterns are coded as follows:  A=Terrestrial, Food Crop;  B=Terrestrial,  Non-Food Crop; C=Aquatic, Food Crop;
   D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Gceenhouse, Non-Food; G=Forestry; H=DomestiG Outdoor;  l=indoor.
/  These data are not required in accordance with 158.150.
                                                             40

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                                                         TABLE A
                                      GENERIC DATA REQUIREMENTS FOR CHEMICAL TRIMBTHACARB
ta Requirement
I/
Composition
Use 2/
Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission V
58.155 Nontarget Insect

NONTARGET INSECT TESTING -
POLLINATORS;

141-1 - Honey bee acute
         contact toxicity          TGAI

141-2 - Honey bee - toxicity       TEP
         of residues on
         foliage

141-4 - Honey bee subacute
         feeding study

141r5 - Field testing for          TEP
         pollinators
Yes
No
00078515
No
No


No/4



Reserved 5/


No/4
                                                             41

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                                                           TABLE A
                                     GENERIC DATA REQUIREMENTS FDR CHEMICAL TRIMETHACARB
a Requirement
           I/     Use  2/
Composition     Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?  (Yes, No
or Partially)
Bibliographic
  Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(C)(2)(B)?
Time Frame Cor Data
Submission V
8.155 Nontarget Insect - Continued

 JNTARGET INSECT TESTING -
  IATIC INSECTS:
42-1 - Acute toxicity to
        aquatic insects

42-1 - Aquatic insect
        life-cycle study

42-3 - Simulated or actual
        field testing for
        aquatic insects
43-1 - NONTARGET INSECT
       TESTING - PREDATC
hru    AND PARASITES

43-3
(Reserved)/6


(Reserved)/6


(Reserved)/6



(Reserved)/6
/ Composition:TCAI = Technical grade of the active ingredient; TEP = Typical end-use product.
/ The use patterns are coded as follows:  A=Terrestrialf Food Crop; B=Terrestrial, Non-Food; OAquatic, Food Crop:
  D=Aqautic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; l=lndoor.
/ Data must be submitted within the indicated time frames, which begin upon receipt of the Guidance Document.
/ Since Trimethacarb is currently registered only at planting and soil incorporation, there is no potential
  for bee exposure.  Thus, testing beyond the first tier is not required.
i/ Reserved pending development of test methodology.
/ Reserved pending Agency decision as to whether the data requirement should be established.
                                                           42

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                                        TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL: TR1METHACARB
Guideline Citation and Test
Name of Test Substance
§158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Materials
and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods to Verify
Certified Limit
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
MP
MP
MP

MP
MP
MP
MP
MP
MP
Guidelines
Status
R
R
R

CR
R
R
R
R
R
Data Must Be
Are Data Footnote Submitted Within
Required Number Time Frames Listed
Yes No Below !/
Yes
Yes
Yes

Yes
Yes
Yes
Yes
Yes
Yes
2/
2/
2/

21
2/
2/
2/
2/
2/

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                                                      TABLE B
              PRODUCT SPECIFIC DATA REQUIREMENTS TOR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL: TRIMETHACARB
Guideline Citation and
Name of Test
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-11 - Oxidizing or Reducing
Action
63-15 - Flaranabllity
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Mlsciblllty
63-20 - Corrosion Characteristics
Test
Substance



MP
MP
MP
MP
MP
MP
MP
MP
MP
Guidelines
Status



R
CR
CR
CR
R
R
CR
CR
R
Are Data Footnote
Required Number
Yes No



Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Data Must Be
Submitted Within
Time Frames Listed
Below I/



2/
2/
2/
2/
2/
2/
2/
2/
2/
MP = Manufacturing-use Product; R = Required; CR = Conditionally Required
I/ Data must be submitted within the Indicated time frame, based on the date of the Guidance Document.
2/ There are no federally registered manufacturing use products containing trlmethacarb.  Data will be required for
   registration of manufacturing use products.
                                                         44

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                                             TABLE C
PRODUCT SPECIFIC REQUIREMENTS FOR END USE PRODUCTS CONTAINING CHEMICAL: TRIMETHACARB
ideline Citation and Test Guidelines
rte of Test Substance Status
58.120 Product Chemistry
Product Identity:
61-2 - Description of Beginning EP R
Materials and Manufacturing
Process
61-3 - Discussion of Formation of EP R
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis EP CR
62-2 - Certification of Limits EP R
62-3 - Analytical Methods to Verify EP R
Certified Limits
Physical and Chemical Characteristics
63-2 - Color EP R
63-3 - Physical State EP R
63-4 - Odor EP R
63-5 - Melting Point TGAI R
Are Data Footnote
Required Number
Yes No
[xi n
1X1 l~]
[x] n
ix] n
[X] [ ]
[xi n
[xi n
ix) n
[x] n
Data Must Be
Submitted within
Time Frames Listed
Below I/
6 Months
6 months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
6 Months
                                                   45

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Ldeline Citation and
ne of Test
                                        TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING CHEMICAL: TRIMETilACARB .

                                                                                         Data Must Be
                            Test      Guidelines       Are Data        Footnote          Submitted within
                          Substance     Status         Required        Number            Time Frames Listed
                                                                                         Below V
 Are Data
 Required
Yes      No
 S.I20 Product Chemistry (Continued)

 aical and Chemical Characteristics
>ntinued)

 3-7 - Density, Bulk Density, or
       Specific Gravity

.3-12 - pH

.3-13 - Stability

•3-14 - Oxidizing or Reducing
        action

53-15 - Flammability

53-16 - Explodability

53-17 - Storage Stability

S3-20 - Corrosion Characteristics
                             EP


                             EP

                             TGAI

                             EP


                             EP

                             EP

                             EP

                             EP
 [X]
CR
R
CR
CR
R
R
R
IX]
[X]
(X)
ixl
IX]
[X]
[X]
6 Months


6 Months

6 Months

6 Months


6 Months

6 Months

15 Months

6 Months
::::::::: i ::::::::::::::::::::::::::::::::::::::::::::::
EP = End-use Product; TGAI- Technical Grade of the active ingredient; R = Required; CR = Conditionally Required
I/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
                                                             46

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                                                        TABLE B
                PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING  CHEMICAL TRIMETHACARB
                                                V
Data Requirement
Composition
Does EPA Have
Data To Satisfy
This Require-
ment?  (Yes, No
Bibliographic
  Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)7
Time Frame for Data
Submission
§158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral Toxlcity - Rat MP No
81-2 - Acute Dermal Toxicity MP No
- Rabbit
81-3 - Acute Inhalation Toxicity MP No
- Rat
8l-l» - Primary Eye MP No
Irritation - Rabbit
81-5 - Primary Dermal MP No
Irritation - Rabbit
81-6 - Dermal Sensltlzatlon MP No
Guinea Pig


Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
  I/ Composition:  MP = Manufacturing-use product.
  ?/ There are no federally registered manufacturing use products containing trlmethacarb.   Data will be required for
     registration of manufacturing use products.
                                                             47

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                                                      TABLE C
              PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING CHEMICAL TRIMETHACARB
ta Requirement
Composition"
Does EPA Have
Data To Satisfy
This Require-
ment?  (Yes, No
or Partially)
Bibliographic
  Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 2/
58.135 Toxicology

ACUTE TESTING

81-1 - Acute Oral Toxicity - Rat

81-2 - Acute Dermal Toxicity
        - Rabbit
t
81-3 - Acute Inhalation Toxicity
        - Rat

81-4 - Primary Eye
        Irritation - Rabbit

81-5 - Primary Dermal
        Irritation - Rabbit

91-6 - Dermal Sensitization -
       Guinea Pig
    EP

    EP


    EP


    EP


    EP


    EP
  Yes

  No.


  No


  No


  No


  No
000128130
No  3/

Yes 4/   9 Months


Yes 4/   9 Months


Yes 4/   9 Months


Yes 4/   9 Months


Yes 4/   9 Months
/  Composition: EP = End Use Product
/  Data must be submitted within the idicated time frame, based on the date of the Guidance Document.
/  Data acceptable for both end use formulations ( 15% granular and  50% WP).
/  Data needed for both end use formulations ( 15% granular and 50% WP).

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          REQUIREMENT FOR SUBMISSION OP GENERIC DATA

     A.  This portion of the guidance document Is a Notice
Issued under the authority of PIPRA sec. 3(c)(2)(B).  The
tables following this section list the data required for
maintaining the reglstrablllty of each product.

     EPA has determined that additional generic data described
In Table A must be submitted to EPA for evaluation In order
to maintain In effect the reglstratlon(s) of your product(s)
Identified as an attachment to the cover letter accompanying
this guidance document.  As required by PIPRA sec. 3(c)(2)(B),
you are required to take appropriate steps to comply with
this Notice.

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

   B.  What Generic Datal/ Must be Submitted.  You may deter-
mine which generic data you must submit by consulting Table A
at the end of this chapter.  That table lists the generic
data needed to evaluate the continued reglstrabillty of all
products, and the dates by which the data must be submitted.
The required studies must be conducted in accordance with
EPA approved protocols (such as those contained in the Pesticide
Assessment Guidelines 2/ or data collected under the approved
protocols of the Organization for Economic Cooperation and
Development (OECD).  If you do not wish to develop data
in support of certain uses appearing in your labeling, you
may delete those uses at the time you submit your revised
labeling.

     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
   _!/ 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, regardless
of the product's unique composition or specific 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).

   £/ The Pesticide Assessment Guidelines are available In hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va.  22161.
                              49

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for each major formulation category (e.g., emulsiflable concen-
trates, 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;  "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 III of this document.

   C.  Options Available for Complying With Requirements
       to Submit Data

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

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

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

                              OR

    2.  Notify EPA that  you-have entered  into an 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.

                              25

    3.  Pile with EPA a  completed "Certification of Attempt to
    Enter  Into an Agreement With Other Registrants for Develop-
    ment of Data" (EPA Form 8580-6, Appendix II-U)*/
      »/  PIFRA  sec.  3(c)(2)(B)  authorizes  Joint  development  of
data  Uy  two  or more registrants, and provides a mechanism by
which parties  can obtain  an  arbitrator1s  decision  if  they agree
to  Jointly' develop  data but  fail to agree on. all the  terms  of
-the agreement.  The statute  does not compel "any registrant  to
agree to develop data Jointly.
               (Footnote continued  on next page)

                              50

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                              OR

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

                              OR

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


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

     EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required data
or how quickly the data must be submitted.  If the 'test
procedures you plan to use deviate from (or are not specified
in) the registration guidelines or protocols contained in
the reports of the Expert Groups to the Chemical Groups,
Organization for Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must submit the protocol
for Agency review prior to the initiation of the test.

     If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time.  The extension
request must be submitted in writing to the Product Manager.
(Footnote continued from previous page)
       In EPA's opinion, Joint data development by all regis-
trants subject to a data requirement 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 unnecessarily large number of
animals to testing.

      As noted earlier, EPA has discretion 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 should encourage Joint 'testing rather than duplicative
testing, and that suspension should be withheld in certain cases.
to further this goal.  Accordingly,'if (1) a registrant has
informed us of his Intent to develop 'and submit data required
by this Notice; and (2) a second- registrant 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  PIPRA Section 3(c)C2)(B).(lli)];
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.

                             51

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The extension request should state the reasons why you believe
that an extension is appropriate.  While EPA considers your
request, you must strive to meet the deadline for submitting
the required data.


III.  REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA

     Note:  Unless stated otherwise in Section I, Regulatory
Position and Rationale, this Section applies only to manufac-
turing use products, not to end use products.

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

     Table B—Product-Specific Data Requirements for Manufacturing
Use Products—lists the product specific data you must submit.
Data that are required to be submitted are identified in the
column of those tables entitled "Must Data By Submitted
Under §3(c)(2)(B)."


IV.  SUBMISSION OP REVISED LABELING

Motet  "This section' applies to end use products only to the
extent described in Section I (Regulatory Position and
Rationale).  Otherwise, the following information pertains
exclusively to manufacturing use products.

     FIPRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 40 .CPR 162.10 (see
Appendix IV-1) and are summarized for products containing
this active Ingredient as part of this Guidance Document
(See Appendix IV-2).  Applications submitted in response to
this notice must include draft labeling for Agency review.
V Product specific data pertain to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.

                              52

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     If you fail to submit revised labeling information
complying with this section (supplemented by requirements
described in Section I, Regulatory Position and Rationale),
EPA may issue a notice of intent to cancel the registration
under PIFRA sec. 6(b)(l).

                      A.  Label Contents

     40 CPR 162.10 requires that certain specific labeling
statements appear at certain locations on the label.  This
is referred to as format labeling.  Specific label items
listed below are keyed to Appendix IV-2.

     Item 1.  PRODUCT NAME - The name, brand or trademark Is
required to be located on the front panel, preferably centered
in the upper part of the panel.  The name of a product will
not be accepted if it is false or misleading.

     Item 2.  COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.

     Item 3.  NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text.  The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units.  See Appendix IV-1.  [40 CPR
I62.10(d)]

     Item 4.  EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No."  The registration number must be set in type of a-
size and style similar to other print on that part of the
label on which it appears and must run parallel to it.  The
registration number and the required Identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.  See Appendix IV-1.
[40 CPR I62.10(e)]

    Item 5.  EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or Immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the Immediate
container cannot be clearly read through such wrapper or container
See Appendix IV-1.  [40 CPR I62.10(f)]

                               53

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    Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel.  The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel.  It must not be
placed in the body of other text.  See Appendix IV-1.  [40 CFR
I62.10(g)]

    Item 6B.  POUNDS PER GALLON STATEMENT - .For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be Indicated on the label.

    Item 7.  FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline.  The table below shows the minimum type
size requirements for various size labels.

    Size of Label        Signal Word          "Keep Out of Reach
    on Front Panel       Minimum Type Size       of Children"
    in Square Inches     All Capitals          Minimum Type Size

    5 and under                6 point              6 point
    above 5 to 10             10 point              6 point
    above 10 to 15            12 point              8 point
    above 15 to 30            14 point             10 point
    over 30                   18 point             12 point

    Item 7A.  CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely.  See Appendix IV-1.
[40 CFR I62.10(h)(l)(ii)]

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

    Item 7C.  SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a  toxicity Category I on the basis of oral, dermal,
or inhalation toxicity,' the word "Poison" shall appear on the
label in red on a background of distinctly  contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON.  See Appendix IV-1.  [40 CFR 162.10(h)(1)(1)]

    Item 7D.  STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III.  See Appendix IV-1.  [40 CFR 162.10(h)(1)(ill)]


                               54

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    Item 7E.  REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all produces, unless all
required precautionary statements appear on the front panel.
See Appendix IV- 1.  [40 CPR 162 .10(h) ( 1) ( ill) ]

    Item 8.  SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding -the directions for use, and it is preferred
that these statements be surrounded by a block outline.  Each
of the three hazard warning statements must be headed by the
appropriate hazard title.  See Appendix IV- 1.  [40 CPR 162.10
    Item 8A.  HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage.  See Appendix IV- 1.  [MO CPR 162.10
    Item 8B.  ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage.  See Appendix IV- 1.  [40 CPR
    Item 8C.  PHYSICAL OR CHEMICAL HAZARD

    1.  Flammabillty statement.  Precautionary statements relating
    to flammabllity of a product are required to appear on the
    label if it meets the criteria in- Appendix IV-3.  The require-
    ment is based on the results of the flashpoint determinations
    and flame extension tests required to be submitted for all
    products.  These statements are to be located in the side/back
    panel precautionary statements section, preceded by the
    heading "Physical/Chemical Hazards."  Note that no signal
    word is used in conjunction with the flammabllity statements.

    2.  Criteria for declaration of non-f lammability .  The
    following criteria will be used to determine if a product
    Is non-flammable;

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

        b.  A "non-flammable liquid" is one having a flashpoint
        greater than 350°P (177°C).
                               55

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

            1.   The flame extension is zero inches;

            11.  There is no flashback;  and

            ill.  The flashpoint of the  non-volatile liquid
            component is greater than  350°P (177°C).

        3.   Declaration of non-flammabillty.  Products which
        meet the criteria for non-flammabillty specified
        above may bear the notation "non-flammable"  or "non-
        flammable (gas, liquid,  etc.)" on the label.  It ma*
        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 t^pe
        size) in any way that may detract from precaution.

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

    Item 9A.  RESTRICTED USE CLASSIFICATION - PIPRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either  general or restricted use.   Products classified
for restricted use may be limited to use by certified applicators
or persons  under their direct supervision (or may be subject
to other restrictions that may be Imposed by regulation).
                           • * *
    In the  Registration Standard, the  Agency has (1) indicated
certain formulations/uses are to be restricted (Section  I
Indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.

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

     If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration.  During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR  I62.11(c).  You will be notified of
the Agency's classification decision.


                                56

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     Classification Labeling Requirements

     If Section I of this Guidance Document indicates that
your product has been classified for restricted use, the
following label requirements apply:

     1.  Front panel statement of restricted use classification.

         a.  The statement "Restricted Use Pesticide" must
         appear at the top of the front panel of the label.
         The statement must be set In type of the same
         minimum size as required for human hazard signal
         word (see table'in 40 CPR 162.10(h)(1)(iv)

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

     2.  Some but not all uses restricted.  If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:

          a.  You may label the product for Restricted use.
     If you do so, you may Include on the label uses that
     are unrestricted, but you may not distinguish them
     on the label as being unrestricted.

          b.  You may delete all restricted uses from your
     label and submit draft labeling bearing only unrestricted
     uses.

          c.  You may "split" your registration, i.e., register
     two separate products with identical formulations, one
     bearing only unrestricted uses, and the other bearing
     restricted, uses.  To do so, submit two applications  for
     reregistration, each containing all forms and necessary
     labels.  Both applications should be submitted  slmul-
     taneo.usly.  Note that the products will be assigned
     separate registration numbers.
                                 57

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    Item 9B  [There is no Item 9B] .

    Item 9C.  MISUSE STATEMENT - All products must bear the
misuse statement, "It is a. violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.

    Item-lOA.  REENTRY STATEMENT - If a reentry interval
has been established by the Agency,  it must be included on
the label.  Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983-

    Item 10B  [There is no Item 10B] .

    Item IOC.  STORAGE AND DISPOSAL SLOCK -  All labels are
required to bear storage and disposal statements.  These
statements are developed for specific containers, sizes, and
chemical content.  These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use.  This heading must be set in the same type sizes as
required for the child hazard warning.  Refer to Appendix
IV-4 to determine the disposal instructions appropriate for
your products.

    Item 10D.  DIRECTIONS FOR USE - Directions for use must
be stated in terras which can be easily  read and understood by
the average person likely to use or to  supervise the use of
the pesticide.  When followed, directions must be adequate to
protect the public from fraud and from  personal injury and to
prevent unreasonable adverse effects' on the environment.  See
Appendix IV- 1.  [UO CFR 162.10] '
    B.  Collateral . Labeling'

    Bulletins,  leaflets,  circulars, brochures,  data  sheets,
flyers, or  other  written  or graphic printed  matter which  is
referred  to on  the  label  or which  is  to  accompany the  product
are termed  collateral  labeling.  Such labeling  may not bear
claims or representations that differ in substance from
those accepted  in connection with  registration  of the  product.
It should be made part of the response to this  notice  and
submitted for review.
                               58

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V.  INSTRUCTIONS FOR SUBMISSION

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

    1.  Within 90 days from receipt of this document, you must
submit to the Product Manager In the Registration Division at
the address given at the end of this section the "FIFRA Section
3(c)(2)(B) Summary Sheet" EPA Form 8580-1.  Refer to'Appendix
II-3 with appropriate attachments.

    If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice.  This Information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section.  (Actual studies are not to be submitted.)

    2.  Within 6 months from receipt of this document you must
submit to the Product Manager on the Registration Division:

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

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

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

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

        e.  Evidence of compliance with data support requirements
    of PIPRA sec. 3(c)(l)(D).  Refer to 40 CPR 152.80-152.99
    for latest requirements.

    3.  Within the times set forth in Table A, you must submit
to the Registration Division all generic  data, unless you  are
eligible for the formulator's exemption.  If for any reason any
test  is delayed or aborted  so that the agreed schedule cannot be
met,  notify the Product Manager and the Office of Compliance
Monitoring.
                                 59

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B.  For Manufacturing Use Products containing Trimethacarb
    in combination with other active Ingredients

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

    If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a data
requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice.  This Information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section.  (Actual studies are not to be submitted.)

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


C.  For End Use Products containing  Trimethacarb alone or in
    combination with other active ingredients;

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

    If on the Summary Sheet*.you commit to develop  the data,
request a minor chemical exemption, present arguments -that a
data requirement is not applicable, o'r submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting Information)  to the Office of
Compliance Monitoring, which will be monitoring the data generated
in  response to this notice.  This information should be submitted
to  the Office of Compliance Monitoring at the address given at
the end of this section.   (Actual studies are not to be submitted.)

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

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

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

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

                               60

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

        e.  Evidence of compliance with data support requirements
    of PIPRA sec. 3(c)(l)(D).  Refer to 40 CPR 152.80-152.99
    for latest requirements.

     3.  Within the time frames set forth in Table A, submit all
generic data, unless you are eligible for the formulator's
exemption.


D.  For intrastate products containing Trimethacarb either as
    the sole active Ingredient or in combination with other
    active ingredients

    These products are being called in for full Federal
registration.  Producers of these products are being sent
a letter instructing them how to submit an application for
registration.


E.  Applications and other required information should be
submitted to the following address:

    Jay S. Ellenberger  Product Manager 12
    Registration Division (TS-767C)
    Office of Pesticide Programs
    Environmental Protection Agency
    401 M St., SW.
    Washington, D.C.  20460
    Phone No. (703) '557-2386

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

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


                                61

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                                      Appendix II-l

          Guide to Use of This Bibliography


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.

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

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

FORM  OF ENTRY.  In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, -in the case of material
submitted to EPA, by a description of the earliest known
submission.  Bibliographic conventions used ,reflect  the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
                            62

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                                   Appendix II-1 (continued)

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

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

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

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

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

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

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

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


                           63

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


  MRID            CITATION

00034769 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
            Toxicities of Environmental pollutants to Birds.  By U.S. Fish
            and Wildlife Service, Patuxent Wildlife Research Center.  Wash-
            ington, D.C.: U.S. FWS.  (Special Scientific Report—wildlife
            No. 191; report no. 33423a; also in unpublished submission re-
            ceived Mar 28, 1979 under 3125-236; submitted by Mobay Chemical
            Corp., Kansas City, Mo.; CDL:237905-B)

00051311 Newell, G.W. (1968) Letter sent to Rene Blondeau dated Jun 10, 1968
            [Demyelination potential of SD 8530]: Project No. BC 868-17.
            Final rept.  (Unpublished study received Jun 10, 1968 under
            unknown admin, no.; prepared by Stanford Research institute,
            submitted by Shell Chemical Co., Washington, D.C.; CDL:107992-A)

00051312 Newell, G.W. (1967) Letter sent to Rene Blondeau dated Oct 3, 1967
            [Results of demyelination study in laying hens—Technical SD
            8530]: Project No. 868-14.  Final rept.  (Unpublished study
            received Oct 3, 1967 under unknown admin, no.; prepared by Stan-
            ford Research Institute, submitted by Shell Chemical Co., Wash-
            ington, D.C.; CDL:107991-A)

00070071 Shell Chemical Company  (1968) Metabolism Studies.  (Unpublished
            study received Oct 15, 1969 under 9F0843; CDL:091458-N)

00070072 Shell Chemical Company  (1968) Residues in Milk from Cow Feeding
            Studies with Carbamic Acid, Methyl-, 4-(Hydroxymethyl)-3,5-xylyl
            Ester.   (Unpublished study received Oct  15, 1969 under 9F0843;
            CDL:091458-0)

00070656 Narcisse, J.K.  (1967) Letter  sent to Rene Blondeau dated Aug 1,
            1967  [Results of a repeated dermal  toxicity study  (rabbit) and
            a saturated vapor  toxicity study  (rat) of SD 8530] : Project
            No. B 868-1, Report  No.  44.   (Unpublished study received Oct  15,
            1969 under 9F0843; prepared by Stanford  Research Institute,
            submitted by Shell Chemical Co., Washington, D.C.; CDL:091458-F)

00070659 Newell, G.W.  (1967)  Letter  sent  to Rene  Blondeau dated Oct  3,  1967
             [Results of  a demyelination study,  in laying hens, of Technical
            SD  8530]: Project  No.  868-14.   Final  rept.   (Unpublished study
            received Oct 15,  1969  under 9F0843; prepared by Stanford Re-
            search  Institute,  Dept.  of Agricultural  and  Environmental Tox-
             icology, submitted by Shell Chemical  Co., Washington, D.C.;
            CDL:091458-J)

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


  MRID            CITATION

00070662 Shell Chemical Company (19??) Residues in Cow Tissues from Feeding
            Studies with Carbamic Acid, Methyl-, 4-(Hydroxymethyl)-3,5-xylyl
            Ester.  (Unpublished study received Oct 15, 1969 under 9F0843;
            CDL:091458-P)

00070664 Shell Development Corporation (1966) Determination of SD 8530
            Residues in Agricultural Crops:  A Tentative Method Involving
            Column Cleanup and Enzyme Inhibition-spectrophotcmetric Measure-
            ment.  Analytical method MMS-78/66 dated Dec 1966.  (Unpublished
            study received Oct 15, 1969 under 9F0843; CDL:091458-S)

00070967 Shell Chemical Company (1968) Residue Data Developed from the Use
            of Landrin Insecticide on Corn.   (Compilation;  unpublished study
            received Oct 14, 1969 under 9F0843; CDL:091456-B)

00078515 Harris, C.R.; Svec, H.J. (1970) Laboratory Studies on the Contact
            Toxicity of Some Insecticides to Honeybees: Mobay Report
            NO. 28755.  (Canada, Dept. of Agriculture, Research Institute;
            unpublished study; CDL:120480-AL)

00095891 Shell Development Company (1968) Liquid Scintillation Counting
            of 14C.  Method MMS-110/68 dated Oct 1968.  (Unpublished study
            received Aug 1, 1972 under 9F0843; CDL:093139-G)

00095892 Shell Development Company (1968) Packed Tube Combustion Method
            for 14C.  Method MMS-111/68.  (Unpublished study received Aug
            1, 1972 under 9F0843; CDL:093139-H)

00095893 Potter, J.C.; Loeffler7 J.E. (1968) Metabolic Fate of SD 8530 in
            Plants: Part III. 14C Residues in Soybeans.  (Unpublished
            study received Aug 1, 1972 under 9F0843; submitted by Shell
            Chemical Co., Washington, D.C.;  CDL:093139-I)

00095900 Shell Chemical Company (1970) 1969  Residue Data for SD 16627 on
            Corn from Nebraska,  (unpublished study received Jul 2, 1970
            under 9F0843; CDL:093546-B)

00095904 Shell Chemical Company (19??) Recovery Data for Landrin (TM) In-
            secticide in Corn.  (Unpublished study received Jun 5, 1969
            under 9F0843; CDL:093546-F)

00095906 Shell Development Company (1968) Determination of Carbamic Acid,
            Methyl-, 3,4,5-trimethylphenyl Ester: GLC—Electron Capture
            Method.  Method MMS-107/68 dated Jul 1968.  (Unpublished study
            received Jun 5, 1969 under 9F0843; CDL:093546-I)
                                       65

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


    MRID            CITATION

  00095907 Shell Development Company (1969)  Determination of Landrin (TM)
              Insecticide Residues: GLC Electron Capture Method.   Method
              MMS-115/69 dated Mar 1969.  (Unpublished study received Jun
              5, 1969 under 9F0843; CDL:093546-J)

  00095908 Shell Development Ccmpany (1969)  Determination of Landrin (TM)
              Insecticide Metabolic Aglycone Residues in Crops: GLC-electron
              Capture Method.  Method MMS-118/69 dated Mar 1969.   (Unpub-
              lished study received Jun 5, 1969 under 9F0843; CDL:093546-K)

  00095909 Gibson, M.E. (1970) Letter sent to George  J. Beusch dated Jan  14,
              1970: Landrin in corn.  (U.S.  Dept. of  Agriculture,  Science  and
              Education Administration, DO;  unpublished study; CDL:098779-A)

  00095928 Slade, M.; Casida, J.E. (1970)  Metabolic fate of 3,4,5- and 2,3,5-
              Trimethylphenyl methylcarbamates, the major constituents in
              Landrin insecticide.  Journal  of Agricultural and Food Chemistry
              18(3):467-474.  (Also in unpublished submission received Jan
              18, 1971 under 9F0843; submitted by Shell Chemical Co., Wash-
              ington, D.C.; CDL:093138-AD)

  00128130 Myers, R.; Christopher, S.; Mika, E.; et al. (1982) Landrin: Acute
              Tbxicity and Irritancy Studies: Project Report 45-173.  (Un-
              published study received Dec 9, 1982 under 264-381;  submitted
              by Union Carbide Agricultural  Products  Co., Inc.,  Research
              Triangle Park, NC; CDL:249422-A)

  00130616 Union Carbide Agricultural Products Co., Inc. (1983)  [Properties
              of Trimethacarb].  (Compilation; unpublished study received
              Aug 2, 1983 under 264-381; CDL:250890-A)

GS0112-001 Zee, K. (1970) Method tryout for Landrin on corn.  In EPA Off-
              icial correspondence  file for Petition OF0843.

GS0112-020 Tyl, R. (1984) A Teratological Evaluation of Broot (Trimethacarb)
              in Fischer 344 Rats: Project Report 46-160.  Unpublished study
              prepared by Bushy Run Research Center,  Export, PA. 427 p.

GS0112-021 Tyl, R. (1984) A Teratological Evaluation of Broot {Trimethacarb)
              in New Zealand White  Rabbits: Project Report 46-161.  Unpublished
              study prepared by Bushy Run Research Center, Export, PA. 288 p.

GS0144-012 Johnson,; Finley, M.  (1980)  Handbook of Acute Toxicity of Chemicals
              to  fish  and Aquatic  Invertebrates.  USDI  Publication  137,
              Washington, D.C.


                                           66

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                           Append ix   II-3
                                                                                 OMB AoorovalNo. 2000-046S (Exoina 12-31-83}
                 FiFRA SECTION 3(C)(2)(B) SUMMARY SHEET
                                                                                          EPA REGISTRATION NO.
PRODUCT NAME
APPLICANTS NAME
                                                                                          DATE GUIDANCE DOCUMENT ISSUED
  With respect n tin requirement to submit "generic" data imposed by the FIFRA action 3(C)(2)(B) notice contained in the referenced
  Guidance Document. I am responding in the following manner.
          I will submit data in a timely manner to satisfy the following requirements. If the ten procedures I will use deviate from (or are not
          specified ml the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to tne Chemicals Group, 01 CO
          Chemicals Testing Programme, I enclose the protocols that I will use:
    O 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(CK2)(BMii) to satisfy the following data
          requirements. The tests, and any required protocols, will be submitted to EPA by:
  NAME OF OTHER REGISTRANT
    LJ 3. I enclose a comoleted "Certification of Attempt to Enter Into an Agreement witn Other Registrants for Development of Data" with
          respect to the following data requirements:
    LJ 4. I request that you amend my registration by aeietjng the following uses (this option is not available to applicants tor new products):
    O 5. t request voluntary cancellation of the registration of this product. (This option is not available to applicants tor new prooucu.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
                                                      DATE
EPA Perm 8580-1 (10-82)
                                                                      66

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                          Appendix II—4
                                                                                 OMB AoofOMt No. 2000046? tExpinr 12-31-831
INTO AN AGREEMENT WITH OTHER REGISTRANTS
fTo «**. crtfyALL ***** FOR D^ELOPMENT OF DATA
1 1 tm duly authorized to represent the following firtn(i) who are ubiect to the require-
ments of • Notice under FIFRA Section 3lc)(2)(B) contained in • Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM


•


ACTIVE INGREDIENT





(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer 10 enter
   into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following reouirec
   items or data:
3. My firm has offered in writing to enter into such an agreement Copies of the off era are attached. That offer was irrevocable and included an ofrer to
   Bound by an arbitration decision under FIFRA Section 3lc)(2HB)(iiil if fmaragreement on all terms could not be reached otnerwise. Thu offer was ma
   to the following firm(s) on the following dated):
NAME OF FIRM

-


DATE OF OFFER




However none of tnose firm(s) accented mv offer.
4. My firm requests that  EPA not suspend the regisrration(s) of my firm's product(s). rf any of the firms named in paragraph (3)-aoo
   have agreed to submit  the data listed in paragraph (2) above in accordance with the Notice. I  understand EPA will  promptly mfoi
   me whether my firm must submit data to avoid suspension of its registration(s) under FIPRA Section 3(c)(2)(B). (This stateme
   does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
 TYPED NAME
                                                       SIGNATURE
                                                                                                            DATE
EPA Form 8S8O-6 (10-82)

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



	Guidance Document for_



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

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










* «







I am complying with
data requirements by
Citing MRID#'






•




.





.
Submit-
ting
Data
(At-
tached)


















(For EPA Use Only)
Accession Numbers
Assigned



•



•









•
                                68

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Appendix III-l (continued)
Registration
Guideline No.
63-13
63-1**
63-15
63-16
63-17
63- 18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/ reducing
reaction
Planmability
Explodablllty
Storage stability
Viscosity
Mlsclbility
Corrosion
characteristics
Dielectric break-
down voltage

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
















I am complying witn
data requirements by
Citing MRID0
















Submit-
ting
Data
(At-
tached)
















(For EPA Use Only)
Accession Numbers
Assigned

















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                                                       APPENDIX  IV-1
Chapter I—Environmental Prelection Agency
  it obtained  the data  from anoth
     (Identify): applicant copied da:
  m a publication: applicant obi
  spy of the data from EPA).
  (4) The applicant shall submit
his\ppllcation a statement that
In lu evaluation of the propeni
cacyAand safety  of the  form
end-use product, may not consi
data  (LS  supporting  the app
exceptXhe following data:
  (1) The data the applicant  has sub-
mitted u EPA under paragraph (b) of
this section:
  (2)  Otter data pertaining  to  the
safety of toe product's active IngredJ
ents. rather  than to the sqiety  of the
end-use procuct: and
  (3) Existing tolerances, /ood additive
regulations.  ^exemptions/  and  other
clearances issued  undev the Federal
Food. Drug,  and Cosmetic Act.
  (e) It the  applicant Knows that any
Item of data he^subm/tted  under this
section was generated
pense of) anothe^pe
ly submitted the
predecessor. USD.
ary 1. 1970. to su
for  registration.
permit,  or amen
use to an existin,
reregistration  <
and the on
reached  wnc
     y (or at the ex-
     in who original-
     to EPA (or  Its
   on or after Janu-
      an application
   xpenmental  use
   nt adding a new
      .ration, or for
      the  applicant
dataXsubmltter have
 agreement  on  the
amount and tr/e terms >pf payment of
any  compensation that\may be pay-
able    under    FIFRA    section
3(cXlXDXli)/wtth regard to approval
of the appllowMon). the applicant shall
submit  to EPA a statement that he
has  fiirnlaaed to each SUCA-identified
original data submitter
  (DA  notification of the applicant's
intent toApply for registration, includ-
ing the proposed product i
  (2) An7 offer to pay the person com-
          wtth regard to the approval
      'application, to the extant re-
       toy  FIFRA sections 3(C)\1XD)
      the
                       Id any result-
                                              regarded as
                                          ^Administrator's
                                      leiollowlng data:
                                        {ted or specifically
                                         it in support of
                                           of data In the
Ing reguirationVshoulc
If it were based on the
consideration of r
  (1) All datasubti
cited  by  the appl
the registration:
  (2)  Each othe/itei
Agency's files wKich:
  O) Concerns the properties or effects
of any such aotlve Ingredient: and
  (11)  Is one/f  the types Not data that
EPA would /equlre to be submitted for
scientific ofeview by EPA u\ihe  appli-
cant  sought the Initial  registration
under B1FRA  Section  3(cXTB>  of  a
product/with composition andMntend-
ed use/ identical to those proposed for
the  Applicant's  product,  undek  the
data/requirements In effect  on\the
      EPA  approves the  applicant's
      it application.

      3. 6. and 29 o< FIFRA. M
OAC. 138 et M*V.)
(44 PR T7953. Mar 11.1979)

B 16ri 0  Lefacllng requlrcnenU.
  (a)  General—<1)  Contents  of  the
label Every pesticide products shall
bear  a label containing  the Informa-
tion specified by the Act and the regu-
lations in this Part. The  contents of a
label  must show clearly and promi-
nently the following:
  (1)  The name,  brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this  sec-
tion:
  (11)  The name and  address of the
producer,  registrant,  or  person  for
whom produced as prescribed  In para-
graph (c) of this section:
  (111) The net contents  as prescribed
In paragraph (d) of this section:

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                                                                                                                                     An
9 169.10

   of this secllon.
  (3) Prominence and leytHHtv-  (D All
words, statements, graphic represents-
lions, designs or other Information re-
quired on the  Isbellng by the Act or
the regulations In  this part  must  be
clearly legible to  a person with normal
vision, and must be placed  with such
consplcuousness  (aa compared  with
other words, statements, designs,  or
graphic matter on  the  labeling) and
expressed In  such terms as to render It
likely to  be  read and understood  by
the ordinary Individual under custom-
ary conditions of purchase and use.
  (II) All required label text  must:
  (A) Be set In 9-polnl or larger type:
  (B) Appear  on a clear contrasting
background: and
  (C) Not be obscured or crowded.
  (31 Laneuave to be luedL All required
 label or labeling text shall appear  In
 the  English language.  However, the
 Agency may require or the applicant
 may propone additional text In other
 language* as Is considered necessary to
 protect the  public. When  additional
 text In another language Is necessary.
 all labeling  requirements will  be  ap-
 plied equally to  both the English and
 other-language versions of the label-
 Ing.
   (4) rtaetmtnt  of taoef-41) Ofnrral
 The label shall appear on or be secure-
 ly attached  to the  Immediate contain-
 er of the pesticide product. For pur-
 poses  of this Section, and the mis-
 brandlng provisions of the Act. "se-
 curely attached"  shall mean  that a
  label can reasonably  be expected to
  remain affixed during the foreseeable
  conditions and period of use. If the Im-
  mediate container Js enclosed within a
                                         fill, 40—Protection of fnvlrenmvnl       Chapter I—Environmental Prelection Agency
                                                                                                     :M.\  iv-l
                                                                                                       Inned)
                                                                                                             9 147.10
wrapper or outside container through
which the label rannol be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer. If It Is a part of the parkage as
customarily distributed or sold.
  (II)  rank cars and other bulk con-
tainers—(A) Transportation. While a
pesticide product Is In transit, the ap-
propriate provisions of 49  CFR Paris
170-189. concerning the lran*porlallon
of hazardous materials, and speclllcal-
ly those  provision* concerning the la-
beling, marking and placarding of has-
ardous materials and the vehicles car-
tying Ihem. define  Ihe basic Federal
requirements. In  addition, when  r-*y
registered  pesticide product Is trans-
ported In  a  lank car.  lank truck or
other mobile or portable bulk contain-
er, a copy of the  accepted label must
be attached  to the  shipping  papers.
and left with the consignee at the lime
of delivery.
   (D) Sloraor.  When pesticide prod-
ucts  are stored  In  bulk  containers.
whether mobile or stationary, which
remain In the custody of  the user,  a
copy of the label of labeling. Including
all appropriate directions for use. shall
be securely attached to the container
In the Immediate vicinity of the dis-
charge control valve.
   (S) False or mltlradtng sfatrmrnfj
Pursuant to section 2 of the
Act.  a pesticide or a device declared
subject   to  the   Act  pursuant  to
 1163.10. ls mlsbranded If Its labeling  la
 false or misleading  In any particular
 Including both pestlcldal and non-pes-
 llcldal claims.  Examples of statements
 or  representations  In the   labeling
 which constitute  mlsbrandlng Include:
   (I) A  false or misleading statement
 concerning  the  composition of  the
 product:
   (ID A  falsa or misleading statement
 concerning the  effectlveneas of  the
 product as a pesticide or device;
   (III) A false  or  misleading statement
 about the value  of the  product for
 purposes other than as a pesticide or
 device:
   (Iv) A false or misleading comparison
 with other pesticides or devices:
   (v) Any statement directly or Indi-
 rectly Implying that the pesticide or
 device Is recommended or endorsed by
 any  agency of  the Federal Govern-
 menl:
   (vl) The name of a pesticide which
 contain* Iwo or  more principal arllve
 Ingredients If  the  name suggests one
 or more bill  mil  all  such prlnrlpnl
 active  Ingredients  even though Ihe
 names of the nlher  Ingredients are
 slRleil elsewhere In the labeling.
   (vll) A true Klnlcmenl  nneil In such a
 wny as to plve n lalse or  misleading Im
 prcsslon In the purchaser.
   (vlll) label disclaimer* wlilch negate
 or ilelrncl (mm Inbcllng slnlemenLi re
 quired under (lie Ac) anil these rcgula-
 I Ions.
   (lx> Claims IM  to the safely of the
 pc*llctdc or  Its Ingredient.*. Including
 statements such as  "safe." '•nonpolsiiii
 on*."  "nnnlnliirloii*."  "harmless" or
 "nontax Ic lo Immiins  unit  pels" with
 or without such a qualifying phrase a.*
 "when used as directed  . and
   (x) Non numerical nnil/or cnmpnrn-
 IIve slalrmciiLs on  the  safely of (lie
 product. Including bill not limited lo
   (A)  "Contain*  all  natural Ingredi-
 ent*":
   (II) "Among  the  least loxlc chemi-
 cals known"
   (C) "Pollution approved"
  (fl)  rinnl prinrerf labrling  (I) Rxcept
 as provided In  paragraph (aMBHll) of
 (his  section,  final  printed  labeling
 mii.il be submitted  and accepted prior
 lo reglslrallon  However, final printed
 labeling need nol be submit led until
 draft label lexis  have  been provision-
 ally accepted by Ihe Agency.
 (II)  Clearly legible reproductions or
 pholo reductions will be accepted for
 unusual labels  such  as those  silk-
 screened directly onto glass or metal
 containers or large bag or drum labels.
 Such  reproductions must be of micro-
 film reproduction quality.
 (bl  Namr. brand, or Irattrmark. (I)
 The name, brand, or trademark under
 which the pesticide product Is  sold
 shall appear on Ihe front panel of Ihe
 label
 (2)  No name, brand,  or Irademsrk
 may appear on the label which:
 (II Is fal*e or misleading, or
 (II)  Has not been approved by  the
 Administrator through registration or
supplemental rrRlftlrallim as an addi-
 tional nnme pm*UKiiOotj| l02.H(hn4).
   (c) Name  and address of producer.
 registrant,  or person  fur whom pro
 duced  An  unqualified name  and ad-
 dress given on Ihe lahel  shall lie cnn
 sldered as Ihe name anil address of Ihe
 producer If the registrant s name an
 pears on Ihe Innel and Ihe registrant I*
 nol Ihe producer, or If the name of Ihe
 person  lor  whom Ihe pesticide  was
 produced appears on the  lahel. II must
 lie qualified  by appropriate wording
 such a*  "Packed for	Dlslrlbtil
 ed by ' * V or "Sold hv	to show
 that the name Is nnl thai of Ihe IHO
 ducer
   (ri) Nfl ineloAf or mrmurr  nf con
 Irnls  The nel wrlulil or measure
 of conlent shall he e*clu*lve nf  wrap
 per.* or  olher mnleilnl*  and shall lie
 the average content miles.* explicitly
 slated a* a minimum quantity
   (2) If  Ihe pesticide Is  a  liquid.  Ihe
 net conlenl  slalemenl  shall  be In
 lerms of liquid measure at flfl' F (20TI
 and shall be expressed In  *-onvenllnnal
 American units of fluid ounces pint.*.
 quart.*, and gallons.
   (.1) If the pesticide Is solid or semlsn
 Mil. viscous or pressurised, or I* a mix
 lure of liquid and solid,  the net con
 lent statement  shall  he  In term* nf
 welghl   expressed   a.*   avoirdupois
 pounds and ounces.
  (41 In all cases, net content shall he
 stated  In lerms of the largest suitable
 nulls. I.e.. "I pound  10 ounce*" rather
 than "20 ounces."
  (5) In addition lo Ihe required  unltji
 specified, net content  may  be es
 pressed In metric units
  (6) Variation  above minimum con-
 tent or around an average Is permissi-
 ble only to the exlenl thai II repre-
 sents deviation  unavoidable In  good
 manufacturing   practice    Variation
 below a stated minimum I* nol permit
 ted. In no case shall the  average con-
 tent of the packages In a shipment fall
 below Hie slalnl nvetage content
  (e)  rrvifurf  rrpiftraUnn  number
The registration  number  assigned to
the pesticide  product at  the lime nf
registration shall appear on the label.
preceded by  the  phrase "EPA Regis-
trallnn No.." or the phrase "EPA  IIrg
No " The registration number shall be
at!, !n typr nf n slr.p and style similar In
olhiif print on ihul  pr.rl  of  the lolml
on. which It appear* and *hsU run pur

-------
§ 141.10

•ll«l to  It.  The  registration number
and  the required Identifying phrase
shall not appear  In mich a manner H
to suggest or Imply recommendation
or endorsement of the product by  the
Agency.
  (f) Producing eifaMliAmrntf reyit-
(radon  number. The producing estab-
lishment reRlslrallon number preced-
ed by the phriuie "KPA Rsl.". of  the
final establishment at which the prod-
uct wan produced may appear In any
suitable locution on the label or Imme-
diate container. It mint appear on  the
wrapper or  outside  container of  the
package If the FPA establishment reg-
Islrallon number on  the Immediate
container  cannot  be  clearly  read
through (inch wrapper or container.
  (R) /ncrwflent •fafement—(1) Oner-
al The label of each pesticide product
mu.il bear a statement which contains
•the name and percentage by weight of
each active  InRredlenl. the total  per-
centage by welghjl of all Inert Ingredi-
ents: and If the. prnllrlde contains ar-
senic In liny form, a statement of  the
percentages of total  and water-soluble
arsenic calculated as  elemental  ar-
srnlc. The active Ingredients must be
designated by the term "active Ingredi-
ents" and the Inert Ingredient* by  the
term "Inert Ingredients." or the singu-
lar forms of these terms when appro-
priate.  Itoth  terms shall be In  the
same type she. be aligned to the same
margin and  be equally prominent. The
statement "Inert Ingredients, none" Is
not  required for pestlrldes which con-
lain 100 percent active  Ingredients.
Unless  the  Ingredient statement Is a
complete analysis of the pesticide,  the
term "analysis" shall not  be used as a
heading for the Ingredient statement.
  (2) /tuition of  Ingrrdlrnt itatement
(I) The Ingredient statement Is  nor-
mally  required on the front panel of
the  label. If there Is an  outside con-
tainer or wrapper through which  the
Ingredient statement cannot be clearly
read, the Ingredient statement must
also appear on such outside container
or wrapper. If the sine or form of the
package  makes  It  Impracticable to
 place the Ingredient statement on the
 front  panel of the label, permission
 may be  granted for the Ingredient
 statement to appear elsewhere
  Till* 40—froUdlon «f fnvtronmvnt

  (II) The tent of the Ingredient state-
ment  must  run parallel  with other
text on the panel on which It appears.
and must be  clearly distinguishable
from and must  not be placed In the
body of other text.
  (3) Namrt to bf vsrd In Inprrrfienf
statement. The name used for each In-
gredient   shall   be   the  accepted
common  name.  If there  Is one. fol-
lowed by the chemical  name. The
common  name may be used alone only
If It Is well known. If no common name
has been established, the chemical
name alone  shall be used. In no case
will the use of a trademark or propri-
etary  name  be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section J8.
  M) Statements of percentaper The
percentages of  Ingredients shall  be
stated  In terms of  weight to-welghl.
The sum of percentages  of the active
and the Inert Ingredients shall be 100.
Percentages shall not be  expressed by
a range of values such as "21-35%.'  If
the uses of  the pesticide product are
expressed as weight of active Ingredi-
ent per unit area, a statement of the
weight of active Ingredient  per unit
volume  of the  pesticide  formulation
shall  also appear  In  the Ingredient
statement.
  (ft) ^ccnrnrv of (fated  perwmfapet
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches,  the value stated  for
each  active Ingredient shall be the
lowest percentage  which  may be pres-
ent.
  (6)  Deterioration.  Pesticides which
change  In chemical composition sig-
nificantly must-meet the  following la-
beling requirements:
  (I) In  cases where It Is determined
that a pesticide formulation changes
chemical composition   significantly.
the product must bear the following
statement In a prominent position on
the label: "Not for sale  or use after
I date I."
  (II) The product must meet all label
claims up to the expiration time Indi-
cated on the label.
  (1)  Inert  InprrrflenU. The Adminis-
trator may  require the  name of any
  Chapter I—Environmental Prelection Agency
                                          A.II.NIMX  IV-I
                                            (rnntInued)

                                                       Q 147.10
  Inert Ingrerilent(s) lo be listed In the
  Ingredient statement If he determines
  that such Ingredient (s I may pose  a
  hararrf to man or the environment
   (III  Warnlnoi  nnrf  precautionary
  .statement*   Required  warning*  and
  precautionary statement*  concerning
  the  general  areas of  loxlcnlnglral
  har.ard Including  hazard to children.
  environmental hazard, and  physical or
  chemical haxarri fall Into two groups;
  those required on the front panel of
  the  labeling  and those which  may
                           appear  elsewhere  Specific  require
                           menl.s concerning cnnlrnl. placement.
                           type sire, and prominence are given
                           below.
                            tl> Rronlrcrf /font panrl trarVmrnft
                           With  the  exception  of the  child
                           har.ard warning statement  Hie lest re
                           qit'red on (he front panel of  the labrl
                           Is determined hv the  Tnxlrllv Calf-go
                           ry of I he pesticide  I lie calrenrv Is a*
                           Signed on the  hn.sls of  the highest
                           hazard shown by anv  of the Indlrnlnrs
                           In the table below
 r>«no_
lip lo ml
 ngttg

                rmm w •»* Sim f«o/1>g

                rrorn »*m»nl*

                ••fiHi ynn ttvy woo
                                               vm iftm wm M^/
                                             iDM 7oon ••» xtnm
                                             hnm
                                                 MUHrn M IT
  (I)  Human hanant alqnat ward—(A)
 ToiMly Catrqarv I All pesticide prod-
 ucts  meeting  the criteria of Toxlclty
 Category I shall bear on  the front
 panel I he signal word "Danger." In ad-
 dition If the product was assigned to
 Tnxlclty Category I on the basis of Its
 oral.  Inhalation or dermal toxlclty (as
 distinct  from  skin  and eye local ef-
 fects) the word "Poison" shall  appear
 In red on  a background of distinctly
 contrasting color and the  skull and
 crossbones shall  appear In Immediate
 proximity lo the word "poison."
  (HI rorfcffv  Category //  All pesti-
 cide product*  meeting the criteria  of
 Toxlrlly Category II shall bear  on the
 front panel the  signal word "Warn-
 ing."
  (C) Toilrllv Catfporv III. All peitl-
 clde products  meeting  Ihe criteria  of
 Toxlrlly Category III  shall bear on
 Ihe fronl panel Ihe signal word "Cau-
 lion."
  r(cttv Calroorv IV.  All pestl-
clde products meeting  the criteria of
Toxlclly Category IV shall bear on the
 fronl  panel the signal word "Caution."
  • F)  Vsr of «ionaf »>nrrf«  Use of any
slRnal word(s) associated with a higher
                          Toxlclly  Category  Is  not  permitted
                          except when the Aceney determines
                          that such labeling Is necessary to pre
                          vent unreasonable adverse  effects on
                          man or the environment  In no case
                          shall more than  one human  harard
                          signal word appear on Ihe front panel
                          of a label.
                           (II) Child nirartf famine  Fvery pes
                          tlclde product label  shall bear  on Ihe
                          fronl panel Ihe slalemcnl "keep out of
                          reach  of children"  Only  In rases
                          where Ihe likelihood of contact  with
                          children during distribution, markel
                          Ing. storage or use Is demonstrated by
                          the applicant to be estremely remote.
                          or If the nature of the pesticide  Is such
                          thai It Is approved (or use on Infants
                          or small children, mav Ihe Arimlnlslra
                          tor waive this requirement.
                           (Ill)  Statement of practical   treat
                          mcnf-(A) Tbxicftp  Catfporv   I  A
                          statement of practical treatment (first
                          aid or other) shall appear on Ihe front
                          panel of the label of  all pesticides fall
                          Ing  Into Toxlclly Category  I on the
                          basis of oral.  Inhalation or dermal log-
                          Icily. The  Agency   may.  however.
                         permit reasonable variations  In I IIP
                         placement of the statement  of  pracll
                                                                                          72

-------
9 162.10

cat treatment Is gome reference such
as "Sec statement of practical treat-
ment on back  panel" appears on the
front panel  near the word "Poison"
and the skull and crosabonea.
  (B) Other toxlcUv cateportt*.  The
statement of practical treatment la not
required on the front panel except  as
described In paragraph thXIMIIIXA) of
this section. The applicant may. how-
ever. Include such a front panel state-
ment at  his option. Statements  of
practical treatment are.  however, re-
qnlred  elsewhere  on  the  label  In
accord with paragraph (h>(3) of  this
section  If they do  not appear on the
front panel
  (Iv) Placement and prominence All
the require  front panel warning slale-
menta  shall be grouped  together on
the label, and ahall appear with suffl-
clent  prominence  relative to other
front panel  text and graphic material
to make  them unlikely  to be over-
looked under customary condltloni  of
purchase and use. The following table
ahowa the minimum type site require-
ments  for  the front panel  warning
statement* on various sizes of labels:
   TIMa 40—Protection of f nvlronmml        Chaplar I—Environmental Protection Agency
MXM * to 10.
Mm* (0 to 11
AbM I) W M
                              almocfiol
6
I
10
If
  (2) OMier required loarnlnpi and pre-
cautionary ttattmenU  The warnings
and  precautionary statements  an  re-
quired below shall appear together on
the label under  the  general heading
"Precautionary    Statements"    and
under   appropriate  subheadings  of
"llacard to Unmans and Domestic Ani-
mals."  "Environmental  Hazard"  and
"Physical or Chemical Harard."
   Iftuard  to ftunjani and dometHe
animal*. (A) Where a hazard elists to
humans or domestic  animals, precau-
tionary statement* are required Indi-
cating  the  particular  hazard,  the
rnutefa) of exposure  and the precau-
tions to be  taken to avoid accident.
Injury or damage. Thp precautionary
paragraph shall  be Immediately  pre-
ceded by the appropriate hazard signal
word.
  IB) The following table depicts typi-
cal precautionary  statement*.  These
statements must  be  modified  or  t\
panded to reflect specific hazards.
i   	
          •«Mt
           Oouok M*>l OB not bnMfio MODI I4M t*
           •Ml OB Ml t* h •(«. on Akx et an
           f PfOHt ggggMt fttfrtwngpsl fat
           Irau0i •» MM On IM bract* neon IA»I et
               MM) Do m 0*1 h Of««. •" •>**• «• «"
                  iltKJMlXt M M iWmnn i*»*wl I
                  *11 tt l>»oiid 01 ob«>«*il Mutf* •»
           otti) taoU bnMt*« won) Idurt or *«qr "*•!
           »«*) COM** ••> *M t«TM 01 CtoMngl I V*n>
           pAM> In* *U Moment rao>*«tf I
          INo pnMMnn; MMin
                                                    SMi «nd *r> boo) i
           MUMO «r> m« Mi o»»oa» to *»•
     MMonl Do no) Sri  h •*•*. en i*H • «"
                                            ftoM •*« ho»4Sn«
                                            (Ann^rtrt. IM old ilJii i • nx»**« I
                                           ft	rrt lomi gi*i| imouii. D> m oil >i OTM.
                                            on^*v or on «*•»•<(. HmM i M*»W l»p.
                                           IMO
  (II) environmental htuardt. Where a
 hazard exists to non target organisms
 excluding humans  and domestic ani-
 mals, precautionary statements are re-
 quired  stating  the  nature  of  the
 hazard  and the  appropriate precau-
 tions  lo  avoid  potential  aeildcnl.
Injury  or damage.  Examples of the
hazard statements  and  the  circum-
stances under which they are required
follow:
  (Al If a pesticide Intended for out-
door use contains en active Ingrrrflen'.
with a mammalian  acute oral UX. of
  100 or less, the statement "This Pesll-
  clde Is Toxic to Wllrlllfe" IM required
    (B)  If a pcsllrMr  Intenrird for out-
  door me contains nn active Inerrrllrtit
  wllh a fish unite IX7» of I pom or losi
  the *Lnlcmrnl "Thli IVsllrldr Is Tnxlc
  lo Fhh" l.i required
    „ nf  100
  Rig/kR or  lew. nr  a .tiitmritte tllrlary
  IX;.. of 50O |>pm or less, the slatrinrnl
  1 Tills IVsllrJdp Is T" tt retiiilierf
    t pi For IISPS Involving  foliar arpllca
  ll<« not conlninliialr
  water by cleanlnc of p<|iil|im«-iil nr ilK
  posal ol wastes
    (III!  I'huilcal nr  r/lrntlcnf hamnt*
  Warning slalemeiil.i on I he MnmmaMI
  Ml or  explosive rtinrnclerlirlr^ of Hi.-
          are rcqiilir.1 ax lollnwt
 n,* fan •> a brfo. m-1 > *.. H .
 nnh p«M ilm. lO-
  KVM ••Mmton H m* »»n I* k kma X • <*il«c«
  ol > H kDm *m Htm,
 M olhv p.M
                                                                                                                           Oo not
                                                    f
-------
  (I) The label clearly shows that the
product  la Intended  for  line only In
manufacturing processes and specifies
thr lypc The product will  not come Into
the hands of the general public except
after Incorporation Into finished prod-
uct*: and
  <*)  The Administrator  determines
that such dlrecllona are not necessary
to prevent unreasonable  adverse  ef-
fecln on man or thr environment.
  (II) Detailed dlreclloa*  for use may
be omitted from the  labeling of  ptntl-
clde products for which sale In limited
to physicians,  veterinarians, or  drug-
gists, provided that:
  (1> The label clearly  stales that the
product  Is for  use only by physicians
or veterinarians;
  (2)  The Administrator determines
that such directions are not necessary
to prevent unreasonable  adverse ef-
fect* on man or the environment; and
  «J> The  product  In also a dniR and
regulated tinder the  provisions of  the
Federal Food. Drug and Cosmetic Act.
  (C) Detailed directions for usr may
be omitted from the labeling of pesti-
cide product* whicn are  Intended for
use only by forrmilatora  In preparing
pesticide*  for aaJe  to the public pro-
vided that:
  (1) There  b  Information  readily
available to the formulators  on  the
composition, loxlelly. methods of use.
applicable restrictions  or limitations.
and effectiveness of the  product for
pesticide purpose*:
  (?) The label clearly  stale* that the
product Is Intended for use  only In
manufacturing, formulating,  mixing.
or repacking for tine as a  pesticide and
specifies the typets) of pesticide prod
net* Involved;
  (J) Thr product as finally manufac-
tured,  formulated, mixed, or  repack-
 aged Is registered: and
   (¥) The Administrator  determines
 that such directions are not nrcrtsary
 to prevent  unreasonable advene  rf
 feels on man or the environment
  Tit), 49—FrotccHon *f Bnvlrmtimnf

  (3» CoAUnti  of Directions for Vtt.
The directions for use  shall Include
the following, under the  headings "Di-
rections for Use*1:
  (I) The statement of use clasnlllca-
tlon as prescribed In I63.KXJ) Immedi-
ately under  the  heading "Directions
for Use."
  (Ill Immediately below  the  state-
ment of use classification,  the state-
ment "It b a violation of Federal law
to use this product In a manner Incon-
sistent with IU labeling."
  (Ill) The «tlc of application, as for
example the crops, animals, arras, or
object to be treated.
  (Iv) The  target peal(a>  associated
with each site.
  (v> The dosage rale associated with
each site and pest
  tvl) The method of application. In-
cluding Instructions for dilution. If re-
quired,  and lypHs) of application ap-
paratus or equipment required.
  (vll) The frequency and timing of ap-
plications necessary to obtain effective
result*  without causing  unreasonable
adverse ef fecla on the environment.
  (vlll) Specific limitations on reentry
to areas where the pesticide has been
applied,  meeting  the  requirements
concerning   reentry  provided   by 40
CFR Part 110
  (In)  Specific dlrecllona concerning
the storage  and  disposal of  the pesti-
cide and It* container, meeting  the re-
quirement* of  40 CFR Part 105. These
Instructions  shall be  grouped  and
appear under  the heading "Storage
and Disposal " This heading must be
set In type ol the same minimum sires
as required for the child hazard warn-
ing (See Table In I KLKKhKlXlvl.)
  (xj Any limitations or  realrlctlo..* on
use required to  prevent unreasonable
adverse effects, such as:
  (A) Required Intervals between ap-
plication and  harvest of food  or  feed
crops.
  (D) Rotational crop restrictions.
  (C) Warnings as required against use
on certain crops, animals,  object*,  or
In or adjacent  to certain areas.
  ID) {Reserved)
  (F) For restricted  use pesticides,  a
slaiemenl that the pesticide may  be
applied under  the direct supervision of
a certified applicator who Is not phys-
ically present at the site of application
                                                                                   Chapter I—Environmental Protection Aajvncy
                                                                                                 AF-INIHX'IV-l
                                                                                                   (ron I I mini)
                                                                                                               9 16? II
 but  nonetheless  available  to  thr
 person .applying the pesticide,  unless
 the Agency has determined that thr
 pesticide  may  only be applied  under
 the direct supervision of a certified ap-
 plicator who Is physically present
   (F)  Other   pertinent  Informal Ion
 which thr  Administrator  determines
 to be necessary lor the protection of
 man anil thr environment.
   (J) Statrmrnt ol  IIaf (.7n.ij|/i<-aMon.
 By October 22. 1910. all pesticide prod-
 ucts musl bear nn their labels a state-
 ment of \nr classification as declined
 In paragraph* < |l( 11 anil (2) «f this sec
 lion Any pesticide product  for  which
 sump use* are classified fur general me
 and other* lor reslrlrled u-.e shall be
 separately Inhrled According In tlir Is
 hrllng standards set forth In this sub-
 section, mid shall bo mnrkeled a.* sepa-
 rate products  with different registra-
 tion number*,  one  bearing  directions
 only for grnrial usc(sl and  I he  other
 hearing direction* for leslrlclod  usrfs)
 except that. If a product lint both re-
 strict rd used) and general use(s>, both
 of these use* may appear on a product
 labeled for restricted use  Such  prod-
 uct* shall br subject to the provisions
 m | 182 IOIJM2).
  II) Oenrrof Vsr naiilflraflnn  Pestl-
 clitc  products  bearing directions  for
 usrtsl classified general shall be la-
 beled with  the  rxacl words "Orneral
 Classification" Immediately below the
 heading "Direction.* lor Usr " And ref-
 erence  to the  general clamlflcallon
 that suggests or Implies that the gen-
 eral utility of  the  pesticide extends
 beyond those purposes and  uses con-
 tained In the Directions for Use will be
 considered a false or misleading state-
 ment under the statutory definitions
 of mlshmnrilng.
  (21 Kntrirtfd  Vir  Cltuiiflcallon.
 Pesticide  products  bearing  direction
 for  u*e(s) classified restricted  shall
 bear statements of restricted use clas-
 sification  on the front panel as de-
 scribed below-
  dl frortl panel itatement of retlHct-
 til uir rfdHl/lcnflon (A) At the top of
 the front panel of the label, set In type
ol  Ihp same minimum slr.es as required
 for human  hazard signal words (see
table In i 162 loilin))(!»)). and appear
Inn with sulllclenl prominence relative
to  other text and Rrnphlc muter)*) on
 Ihr front panrl to make II unlikely to
 br overlooked under customary rondl
 lion* of purchase  mid ii.se. Ihr  stale
 mrnt "Restricted list- Pesticide' «lml|
 appear
   (11) Directly below Mils statement on
 the front panel, a .summary nlnlcmrnt
 of the term* nf rrslilclhui Imtxnrd us
 a  precondition  to  rr-Rhtiaiim,  Miall
 appear If use I* restricted lo certified
 applicators, the following Mulrmrril Is
 required  "For retail sale  lo and nw
 only by Ol lifted Appllcalor* iir (irr
 sons under their direct supervision and
 only for Ihose uses rnveinf liy I lie Per
 lifted  Applicators;  ci-t lltlcallnii •  II.
 however, other irftiilnliiry  reslrlcllnn*
 are Imposed,  the  Administrator will
 drllne the appropriate wording lor I lie
 terms of restriction tiv regulation
   (a.I Advertising  lllrii-rve.il

 KO TO isas*. jut?  3. ivn  40 nt inw
 Aim I  ISIS. 40 Fl< 3S«1I AUB II. l<
 •mended lit 41 Pit MM Prh ft  Uiai

         Crliftla fot dHrrmlnalkm* nr mi

   <)>) Critrria for litunnrr  n( JVoflc/ nl
 ffife\if to Drnv RfvlHmtton.
        ation. or to ffolcf a II.
 (I)  PrJuumpffon. (I) A rrbullalOr prr
 sumpllAii  shall si lie  itiat  a u(>llcr of
 Inlrnl loVleny rrgLstralloii  pufsiiant lo
 section 3?t)<8) of thr Acl  /notice of
 Intent to cVncel  rrplslrntl/n pursuanl
 lo section  WbNI>  of  th>   Act.  or  a
 notice ol InlW  to hol/a  hearing In
 determine  wither iHe  reglslrallon
 Sfinuld be cancVIIrd  of denlr.l. as ap-
 propriate, shall >{? Usurd.  upon a de
 termlnallon by tlreXdmlnlslinlor that
 the pesticide mretX or exceeds any of
 the criteria lor rKkVsel forth In para
 graph (BH3) of tAls *Xcllon.  Upon such
 determination/  thr\ Admlnlstralor
 shall Issue notice by rVllfled mall  lo
 the appllcan/or rrglsl ratal,  a.* the rose
 may be. slating thai tne\f ppllrnnl  or
 registrant/has  thr  oppXjtiinliy  to
Bubmlt evidence  In rebullM ol such
preaumiAlon In accordance  *Jlh para
•raph/a)(4l of this section  1\e appll
cant orY regblranl nhull have l<\ty live
(46Mtays frotn Ihr dnle such n«\lcr Is
sent to submll rvldrm-e In relmltat of
11)1  presumption;  provided. howAvrr.
 lal for good cause shown the AdiiHn
Istrator may grant tin additional 
-------
                                                    75

        nif«nui
             On C"(u*"il
        SfOMAGf: AMD
                                       PRODUCT
                                        NAME
                                »cirw('»ir.nioi|Ni	
                                »iini KicntiniMii	          «(BA

                                IQIM                 loo im i
                                                                      cnon

                                iins rnoinici coni»*is   ins rv  rmu»uo»(   Vv"^


                               KEEPOUrOFnEACHOFCim.DnEN   q(K



                                    CAUTION           «('.



                                    JIAIIUIIH 01 riurtcM mi tunni



                            g VI f t I $' ^ ^^^~  ~^	^~^ ~ "^ T* "iy,—^V- _-" __~"- - I ^"* ^"^~ — -  - "
                               Stir r»iii ion M>niiO'i'i« SI*I|Iniir.»"(>n MI) =;
                                         mi coNi((«s;ri:
                                                        =<©
                                                                        Cnnr  .-

                                                                                                     •o
                                                                                                     •o
                                                                                                     TO
                                                                           w*nniniv
                                                                                    ._.__.

-------
pnECAUlONANV STATCUf NTS


  HUAnDJ lOmjUAN)


  II DOUfVC ANIMALS)
         MAJAnps
    HAJATO3
          rot use




* *«••• •»•**«



    RE INTRV SIAItUfNT
  STORAGE AND

    DISPOSAL
JS
                                RESTRICTED USE


                                    PESTICIDE

                           for rtllU t»1r t» md vii D««r br ttrtlllid
                           •r ftrtem undir l»>t1r dlrid iupir»ttlc* t*d onlj Igr
                              *tl« to«ir«J kr (hi CtrtlHfd tppllcilert CtflKI-
                            PRODUCT

                                 NAME
                          ACtlVC MONCOCNT

                          Mem wcweo«Nij



                          IQ1M.
                          tt« PRODUCT CON»»HS
                                                 IOOOOI
                                              «»» OAUOM
                         KEEP OUT OF REACH OF CHILDREN


                            DANGER—POISON
                                  STAff U«NT Or
                                               l«t*rW|Mt
                      r

                      r

                      r OM SKN

                      r
                      srt
                              row »Pomo«»i. r«c*unDtiA«»
                         BY!
                              MO
                      EPA
                                MO
                                           = «4
                                NCI COMffHIS:
                                                            CHOP
                                                            cnc*
                                                             Ei
                                                             •^-s

                                                             ©
                                                             *-*%
                                                             h
                                                            CHOP
                                                              CHOf
                                                                 CHOP
                                                                                          •a
                                                                                          •a
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                                                                                          o.
                                                                                           <
                                                                                           i
                                          76

-------
                                                                    APPENDIX IV-2
LABELING REQUIREMENTS OP THE FIFRA, AS AMENDED
ITEM
1
2
3
1|
5
6A
6B
7
7A
7B
- LABEL KT.raviRMT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
0? 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.

-------
                                  APPENDIX EV-2 (continued)
ITEM .
7C
7D
7E
B
8A
Be
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
OP 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.
78

-------
                          APPENDIX IV-2 (continued)
ITEM
8c
9A
9C.
10A
IOC
10D
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OP REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
All
cholinesterase
Inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
'Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for 'use
None
r 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
79

-------
                                                   Appendix IV-3
                    PHYSICAL-CHEMICAL HAZARDS
Criteria
I.  Pressurized Containers
    A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
    B,
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.

ALL OTHER PRESSURIZED
CONTAINERS
II.  Non-Pressurized Containers

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

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

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

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

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

                              Flammable.  Keep away from
                              heat and open flame.

                              Do not use or store near
                              heat and open flame.

                              None required.
                                       80

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                                               Appendix IV-M

       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 heading
"STORAGE AND DISPOSAL."  The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
 Size of label
 front panel in
 square inches
 Required type size
 for the heading
 STORAGE AND DISPOSAL
(all capitals)	
 10 and under	6 point
 Above 10 to 15	8 point
 Above 15 to 30	10 point
 Over 30	12 point
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.

A.  Storage Instructions:

All product labels are required to have appropriate storage
Instructions.  Specific storage instructions are not prescribed.
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.


                                        81

-------
                                                 Appendix IV-U
                                                 (continued)

4.  Instructions on what to do if the container is damaged in
    any way,  or if the pesticide  is  leaking or has been
    spilled,  and precautions to minimize exposure if damage occurs

5.  General precautions concerning locked storage, storage in
    original  container only, and  separation of pesticides
    during storage to prevent cross-contamination of other
    pesticides, fertilizer, food, and feed.

6.  General storage Instructions  for household products should
    emphasize storage in original container and placement in
    locked storage areas.

B.  Pesticide Disposal Instructions;

The label of all products,  except those intended solely for
domestic use, must bear explicit  instructions about pesticide
disposal.  The statements listed  below contain the exact wording
that must appear on the label of  these products:

1.  The labels or' 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, MO  CFR
    261 for a hazardous waste must  bear  the following  pesticide
    disposal  statement:
                                        82

-------
3.
                                             Appendix IV-4
                                             (continued)

"Pesticide wastes are toxic.  Improper disposal of excess
pesticide, spray mixture,  or rinsate is a violation of
Federal Law.  If these wastes cannot be disposed of by
use according to label instructions, contact vour State
Pesticide or Environmental Control Agency, or che 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."

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 domes.tic 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 punctur-e.
                                      83

-------
                                               Appendix IV
                                               (continued)
  2.  The labels for all other products must bear container disposal
      instructions,  based on container type, listed below:

  itainer Tvue                          Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities .
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reusedl.^ 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)
i/ Manufacturer may replace this phrase with one indicating
   whether and how fiber drum may be reused.

-------
                                                 Appendix IV-4
                                                 (continued)


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

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

Acrolein
Aldlcarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyrldine
Arsenic acid
Arsenic pentoxide
Arsenic trioxlde
Calcium cyanide
Carbon disulfide
p-Chloroanlllne
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
Endrln
Pamphur
Pluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA,  schradan)
Parathion
                                         85

-------
                                                 Appendix IV-4
                                                 (continued)


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

Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azlde
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0 ,0,0-Tetraethyl dlthiopyrophosphate   (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
                                        86

-------
                                                 Appendix  IV-4
                                                 (continued)


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

Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachlorlde
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidlne hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-l,3,4-metheno-2H-cyclobuta[c,d3-pentalen-2-one
    (kepone, chlordecone)
l,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dlchloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dlchlorobenzene
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,M-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
                                           87

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                                                 Appendix IV-4
                                                 (continued)

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

Isobutyl alcohol
Lead acetate
Llndane
Maleic hydrazlde
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol)   (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
M-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronltrobenzene  (PCNB)
Pentaclorophenol
Phenol
Phosphorodlthioic 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 j4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trlchloroethylene
Trichloromonofluoromethane  (Preon 11®)
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid  (2,4,5-T)
Xylene

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

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