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                                        GUIDANCE FOR THE
                              REREGISTRATTGN OF PESTICIES: PRODUCTS
                               O3OTAIN1NG AS THE ACTIVE INGREDIENT

                                            AIACHLOR
                                            (090501)

                                        CASE NUMBER 0063

                                         CAS 15972-60-8

                                 ENVIRONMENTAL PROTECTION AGENCY

                                   OFFICE OF PESTICIDE PROGRAMS

                                     WASHINGTON, D. C.   20460

                                          November 1984
33
o
            EJED
            EPA-
            560/
            1984.3
Material belongs to:
Office of Toxic Substances Library
U S Environmental Protection Agency
401 M Street, S.W.TS-793
Washington, D.C. 20460
(202) 382-3944

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                         TABLE  OF  CONTENTS


       Introduction 	 1

 I.     Regulatory Position and  Rationale	4

 II.    Requirement for Submission  of Gerferic Data	17

 III.   Requirement for Submission  of Product-Specific
       Data	37

 IV.    Submission of Revised Labeling  and Packaging
       Information.	65

       A.   Label  Contents	65

           1.   Product Name	65
           2.   Company Name and Address	65
           3.   Net Contents	65
           4.   Product Registration Number	65
           5.   Producing  Establishment                        66
               Registration Number	
           6A   Ingredient Statement	66
           6B   Pounds Per Gallon Statement	66
           7.   Front Panel Precautionary Statements	66
           7A   Child Hazard Warning Statements	66
           7B   Signal Word	66
           7C   Skull and  Crossbones and Word Poison	67
           7D   Statement  of Practical  Treatment	6?
           7E   Referral Statement	67
           8.   Side/Back  Panel  Precautionary Labeling	67
           8A   Hazard to  Humans and Domestic Animals	6?
           8B   Environmental Hazard	6?
           8C   Physical or Chemical Hazard	67
           9    Misuse Statement	68
           10A  Storage and Disposal Block	70
           10B  Directions for Use	70

       B.   Collateral Information	70

V.     Instructions  for Submission	71

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                           APPENDICES
                                                              Page

II-l     Guide to Bibliography                                   72

II-2     Bibliography	.-	74

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

II-4     Certification of Attempt to Enter Into an Agreement
          with Other Registrants for Development of Data
          EPA Form 8580-2.	85

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

IV-1       40 CFR 162.10 Labeling Requirements	88

IV-2       Table of Labeling Requirements	93

IV-3       Physical/Chemical Hazards Labeling Statement	96

IV-4       Storage and Disposal Instructions	97
                                ii

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                          INTRODUCTION

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

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

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

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

     EPA  has the authority  under FIFRA §3(c)(2)(B) to require
 that registrants submit data that will answer our questions
 regarding the hazard  that may  result from the intended use
of the  pesticide under  review.  Further, $3(c)(2)(B) provides
 that these data are to  be submitted by those registrants
who do  not qualify for  the  formulator's exemption [FIFRA
 S3(c)(2)(D)].   Normally,  this  means that the registrants who
 are responsible for filling the  data gaps are the manufacturing
use product  producers (basic suppliers of the active ingredient).
However,  end use producers  will  not qualify for the formulator's
 exemption if the source of  their active ingredient: (1) is

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

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

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

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   PRODUCTS SUBJECT TO THE
   REGISTRATION STANDARDS PROGRAM
  ACTION(S) REQUIRED TO
  MAINTAIN REGISTRATION
 I.  Products That Do Not Qualify
    For The Formulator'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  Formulator's Exemption
Only when additional restric-
tions or labeling are needed t
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 "11"
above. If there are no manufacturing use products registered  by any
company end  use products will be required to  be reregistered.

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

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                   I.  REGULATORY POSITION AND RATIONALE

A. INTRODUCTION

Pursuant to the Federal Insecticide, Fungicide,and Rodenticide Act (FIFRA),
S 3(g)» the Environmental Protection Agency ("the Agency") conducts a compre-
hensive program to review the existinq data on registered pesticide active
ingredients and imposes data requirements and use conditions appropriate for
continued registration of products with those active ingredients.  The result-
ing requirements for continued registration are imposed on registrants through
the Registration Standard program for each active ingredient.  As a part of
that program, the Agency has evaluated the available data on alachlor.

this guidance document which includes the registration standard review, des-
cribes the current regulatory position of the Agency on alachlor based on
an evaluation of all products containing alachlor as an active ingredient.
Requests for registrations of substantially similar products will he covered
by this standard.  This document provides the rationale for the Agency's
position and the criteria for continued registration.  It also discusses
interim labeling requirements, tolerances, and Federal registrations
granted under Section 3 of the FIFRA.

In developing its regulatory position, the Agency determines whether available
data indicate that a pesticide has met the criteria for potential unreasonable
adverse effects found in Section 162.11 (a) of Title 40 of the U.S. Code of
Federal Regulations (CFR).  A pesticide meeting the criteria is a candidate
for a Special Review, an intensive risk/benefit analysis which is a modifi-
cation of the Rebuttable Presumption Against Registration (RPAR) process,  itie
Agency's determination as to whether any of the risk criteria has been met and
its rationale for any regulatory action will be summarized in the Position
Document developed through the Special Review program.

Alachlor is the accepted cannon name recognized by the ANSI for the compound
2-chloro-2',6l-diethyl-N(methoxymethyl)acetanilide.  Its empirical formula is
C14H20NO2C1-  
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Alachlor was patented by Monsanto Company (US Patent No. 3,442,945 and 3,547,620>
in 1967 and was first registered for use in I960.  Technical alachlor is being
produced in the United States by Monsanto Agricultural Products Company of
St. Louis, Missouri and at the present time, Monsanto is the sole registrant
of products containing alachlor.

Alachlor is available as a technical material, at 90.0% active ingredient and as
a manufacturing use product containing 60* alachlor for formulation of alachlor
end-use products.  Alachlor is available in granular, microencaDSulated, and
emulsifiable concentrate end-use formulations.

C. REGULATORY POSITION

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

   1. Alachlor is an oncogen and is subject to the Agency's requirement that
      it be considered through a Special Review.  The registrant of alachlor
      products has been made aware that alachlor has met the risk criterion
      for oncogenicity in Section 162.11(a) of Title 40 of the U.S.  Code of
      Federal Regulations.  A position document detailing the available
      information about the toxicity, exposure potential, and benefits from
      alachlor use will be published in connection with the Special Review.
      The Agency expects to make such a document public within the next
      month.

   2. The potential cancer risk from exposure to persons working with alachlor
      appears to be significant based on EPA's reviews of the available
      studies of toxicitv and exposure.  Accordingly, EPA has determined that
      continued use of alachlor products under present terms and conditions
      of registration appears likely to cause unreasonable adverse effects
      on the environment during the period required for the administrative
      process,  ttie administrative process involves review of the issues
      relating to whether and under what terms registrations could be continued
      following final Agency determination on risks and benefits.

      Like most widelv used herbicides, the bulk of the annual use of alachlor
      occurs during the March throuah June period which precedes planting in
      the various parts of the country.  In any given location, application
      occurs during an approximate two week window.  Therefore, succcessful
      management of risks from use during 1985 requires implementation of
      measures which can be effective by the spring of 1Q85.  Completion  of
      labeling changes and implementation of other risk reduction measures
      in a manner which can be final and enforceable for the 1985 use period
      can only be reliably effectuated with the cooperation of the registrant,
      unless EPA takes emergency action pursuant to a finding of imminent
      hazard.  In an effort to ensure that the risks from exposure during the
      period for administrative review are adequately managed, EPA has engaged
      in discussions with Monsanto, aimed at identifying risk reduction measures
      which can be implemented for the 1985 season.  Minutes of the Agency's
      discussion with Monsanto are in the Public Comment Pile where it will
      be available for public inspection.

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    EPA understands that Monsanto will promptly  implement the amendments
    to registrations identified here and will market alachlor products for
    the 1985 season under  these terms and conditions of registration.
    Certain of these requirements were developed from  ideas initiated by
    Monsanto,  but  in all cases the  terms have been determined by EPA to
    represent appropriate  approaches to managing the risks from use of
    alachlor pending final determinations following the special review.
    The Agency will evaluate these  measures following  the 1985 season to
    determine whether they provide  adequate management of risks for any
    further interim period required to reach final action following the
    Special Review.

    In addition, EPA has determiner!, pursuant to FIFRA «3(c)(2)(B), that
    certain data are required to  maintain alachlor registrations in effect
    during  the period of special  review, and those requirements are identi-
    fied in this document.

    Both the amended registration terms and the data requirements set forth
    in this standard are imposed  pursuant to findings  tftich relate only to
    continued  registration during the period for Special Review of alachlor.
    However, it is  likely  that results from and experience with these
    requirements will also be available for consideration by EPA prior to
    any final determination resulting from the Special Review.  Therefore,
    these requirements can permit a more refined assessment of the risks and
    benefits of continued  use of  alachlor.

3.  The registrant  has voluntarily  removed the use of  alachlor on potatoes
    and the Agency  will not permit  the use of any alachlor product on
    potatoes.

4.  During  the  Special Review, the  Agency will not approve registration for
    any new use.

5.  Alachlor appears to leach through soil and has been found in ground water
    in Nebraska and  Iowa.  Alachlor has been detected  in surface water in
    a number of locations, particularly in Iowa and Ohio.  The chemical
   has also been found in tap water from surface water in Ohio.

   Data to more fully assess ground water contamination and runoff contami-
   nation of surface water are being required on an accelerated schedule from
    registrants who produce manufacturing-use products.  Because of possible
    water contamination, the Agency has determined that labeling should advise
   users that alachlor may contaminate ground water and surface water bodies.

6. Handling and application of alachlor can result in significant exposure
    to users.  Consequently, a number of changes in labeling are required
   to address occupational exposure.  Further, a program of information
   and training is required to be made available to all users of alachlor
   products.

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    7. Registrants of manufacturinq use products (MUPs)  containinq alachlor
       nust provide or agree to develop additional data  as specified in the
       tables in this guidance document, in order to maintain existina regis-
       trations of alachlor while the administrative process relatinq to the
       Special Review is underway.  Registrants are  also informed of additional
       data which the Agency will recruire that they  develop if the Special
       Review is ultimately terminated in a manner which will permit continued
       registration of pesticides containinq alachlor.

    8. Manufacturinq-use pesticide products containinq alachlor as a sole active
       ingredient mav be registered for sale,  distribution and formulation
       in the United States, subiect to the terms and conditions specified in
       this document pending the outcome of the administrative process relatinq
       to the Special Review.  Registrants having products not conforming to
       this document must apply to amend the registrations of those products
       containinq Alachlor.  Mixtures and end-use products containing alachlor
       are covered by the labeling requirements set  forth under this standard
       and registrants of *-hose products not conforming  to these labeling
       requirements must also apply to amend their registrations accordingly.

D. RATIONALE FOR REGULATORY POSITION

The Agency has reviewed the available data concerning toxicology, environmental
fate,  ecological effects,  residue chemistry and product chemistry.  Sufficient
data  are  available to show that alachlor causes tumors  in laboratory animals
and that  humans are "exposed to alachlor at levels which raise significant
concerns.

   1.  EPA has completed its preliminary review of the alachlor data base and
       concludes that alachlor is oncogenic in laboratory rats and mice.

         A  two year rat feeding/oncogenic study using technical alachlor
         stabilized with etoxidized  soybean oil at  0.5,  2.5 and 15.0 mg/kq
         bw/dav dosage levels indicated that  alachlor is oncogenic in male
         and  female rats.   Nasal  turbinate  tumors increased significantly
          (p <  0.01)  in both sexes at  15 mgAg/day.  The same tvpe of tumor
         occurred  in one mid-dose female.  An increase was noted in the
          incidence of  thyroid  follicular cell tumors in the high dose male
         group ( 13.3%  in  the hiqh dose compared to fi.7% in control).  Two
         additional  kinds  of tumors,  thvmus lymphosarcoma and adrenal pheno-
         chrcmocytoma  increased significantly (p <  0.05) in the high dose
         females.  Nasal submucosal gland hyperplasia significantly increased
          (P < 0.01)  in both sexes at  the high dose level.

         In a two year rat feeding study, technical alachlor was tested at
         the following dosages: 14.0, 42.0, and 126.0 mq/kq/day and showed
         statistically significant increases  in the following tumors at 42.0
         mq/kg/day and above: nasal turbinates and  stomach tumors occured in
         both sexes; thyroid follicular tumors were observed in males at
         126 mgAd/day.  In additon, occular  lesions and hepatotoxicity
         occured at the lowest dose tested (LOT).

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      In an eighteen month mouse study, the chemical was tested at the
      following dosages: 26.0, 78.0, and 260.0 mg/kq/day and showed a
      statistically significant increase in lung bronchioalveolar tumors
      in females at 260 mg/kq/day (highest dose tested (HOT)).

      In a six-month dog feeding study, technical alachlor was  tested at
      the following dosages: 5.n, 25.0, 50.0, and 75.0 mg/kq/day and
      showed dose related hepatotoxicity at all of the above dosaoes.
      The no-observable-effeet-level (NOEL) was < 5.0 mgAa/dav (LDT).

      In a three generation rat reproduction study, technical alachlor
      was tested at the followina dosages: 10.0 and 30.0 mqAP/day and
      showed the following effects: reproduction NOEL at .10.0 ma/kq/day,
      and reproduction low-effect-level (IFL) at 30.0 mg/kq/day
      (kidney effects in F2 and F3 pups).

2. Although little is known about actual alachlor exposure from treated
   food and feed crops, the Agency has estimated that the potential dietary
   exposure (mg/kg/day) of the U.S. population to alachlor from treated
   food crops may be significant.  The data required through this standard
   should permit meaningful conclusions about actual dietary exposure.

3. Because currently permitted use on potatoes contributes significantly
   to potential exposure based on maximum potential contributions to the
   diet, this Standard requires that registered alachlor products no lonoer
   bear directions for use on potatoes.

4. Non-dietary exposure of people to alachlor occurs principally from agri-
   culture use when it is applied primarily by around boom equipment using
   the band or broadcast method.  Exposure of workers to alachlor occurs
   by dermal and inhalation routes during mixing, loading, sprayinq and
   flagging, and during cleaning and repair of equionent.  The more
   significant exposures occur throuqh the dermal route and result from
   mixing, loading, transfer, cleaning and repair operations.  Up to
   one million workers in the United States can be exposed annually to
   significant levels of alachlor.  Fven though only 1% or 2% of alachlor
   is applied aerially, the exposure is substantially hiaher than for
   other application methods.

5. Contamination of drinking water obtained both from surface water and
   from ground water is an additional route of human exposure to alachlor.

   Available monitoring data show the presence of alachlor in surface water
   and in municipal water supplies in Ohio.  Monitoring studies of several
   rivers in Northwestern Ohio showed alachlor at all sampling stations
   throughout the summer long sampling program during 1981, 1982, and 1983.
   Average alachlor levels in the rivers during these periods ranged UP to
   3.0 micrograms/liter (parts per billion) with peaks far in excess of
   that value.  Tap water from municipal systems drawing water from these
   sources also showed alachlor levels averaging greater than 1.0 ppb.

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   Limited monitoring data also show that alachlor has the potential to
   contaminate ground water.  In 1980, alachlor was found in two wells out
   of 14 sampled in Nebraska at about 0.04 ppb.  In two different counties
   of Northeast Iowa, alachlor was detected in ground water sources at
   levels well in excess of 1.0 ppb.

   The Agency is requiring additional data on an accelerated basis on the
   leaching and mobility of alachlor to examine the potential of alachlor to
   contaminate ground water.  In addition, a monitoring study to evaluate
   the manner and extent of contamination of ground and surface water is
   being required.

€. Exposure to aquatic organisms through runoff is probable, but data indi-
   cate that alachlor is only moderately toxic to freshwater fish and
   slightly toxic to freshwater invertebrates.

7. The Pesticide Incident Monitoring System (PIMS) indicates sixteen inci-
   dents involving aaricultural uses of alachlor alone from 1979 through
   1981.  Of the sixteen incidents, eleven required medical attention, eight
   involved dermal exposure, three involved inhalation exposure, five
   involved ground application, two involved aerial application and three
   involved mixer/loader exposure.  PIMS does not include any details or
   consequences of these exposures, nor does it attempt to validate these
   voluntarily submitted reports.  No fatalities were reported.  TTie PIMS
   data do not provide information on chronic health effects from exposure
   to alachlor, but do support the need for precautions and training
   relating to careful handling of alachlor products.

8. The Agency is requirina the manufacturer to provide all users of alachlor
   products with an opportunity to attend a special training program which
   will be available throughout the nation before the 1985 planting season.
   This program will outline the precautions to be followed in handling
   the alachlor products.

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 E.  CRITERIA FOR REGISTRATION UNDER THIS DOCUMENT

 To be eligible for registration pursuant to this  quidance document, manufac-
 turing-use products and end-use products must meet the following conditions:

     1.  Contain alachlor as the sole active ingredient and,

     2.  Conform to the acute toxicity  limits, product composition, and
         use pattern requirements listed in  Section F of this document.

 Registration of products subject to this document must comply with all terms
 and conditions described in it,  including commitment to fill data aaps on a
 schedule acceptable to EPA and consistent with that required of the present
 registrant.  All registrants and applicants for reaistration under this
 document must follow the instructions  contained in this document and complete
 and submit the appropriate forms within the specified time.

 P.   ACCEPTABLE RANCZS AND LIMITS

      1.   Product Composition Standard

 Technical grade products must contain  at least 60.0 percent alachlor as the
 sole active ingredient.   Each manufacturinq-use product formulation proposed
 for registration must be fully described with an  appropriate certification of
 limits.   In addition,  the active ingredient found in the manufacturing-use
 alachlor products must be substantially similar to that in currently registered
 technical products.   Any manufacturing-use  product not meeting these require-
 ments will be considered a new product and  will not be registerable under this
 guidance document.

      2.   Acute Toxicity Limits

 During the period of administrative process relating to the Special Review,
 the  Agency will permit registration of technical  grade and manufacturing-use
 products containing  alachlor with acute toxicity  category IV for primary eye
 irritation,  toxicity category III for  acute oral, dermal, and inhalation, and
 category IV for primary dermal irritation,  provided that the labeling of those
 products bear appropriate precautionary statements.

      3.   Use Patterns

 For  continued registration under this  document, manufacturing-use and end-use
 products containing  alachlor may be labeled for formulation only into end-use
 products for herbicides used for the control of certain annual grasses, broad-
 leaf weeds  and yellow nutsedge on corn (all  types), soybeans, peanuts, dry
 beans, lima beans, red kidney beans, mung beans,  grain sorghum, sunflower,
 peas, cotton,  and certain woody  ornamentals.  For most uses, alachlor is
 applied  as  a preemergence broadcast or banded ground application.  It may
also be  labeled for  pre-plant and shallowly incorporated application, or in-
 jected into center pivot  irrigation systems on some sites.  However, alachlor
products must  be labeled  to exoressly prohibit aerial application.
                                    10

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 G.   REQUIRED IABELING

 All technical grade,  manufacturing-use(MUP)f and end-use (EUP) products, con-
 taining alachlor must bear appropriate labeling as specified in 40 CFR $
 162.10.  This section contains additional specific information regarding
 label requirements.

 In  addition to the requirements stated in 40 CFR S 162.10, the following in-
 formation must appear on the labeling  of MJPs.

        Listing of Approved Sites

        The labeling must list specific, currently approved sites on which the
        product is intended to be used  after being manufactured into an end-use
        product.

        "Do not discharge effluent containing this product directly into
        lakes streams,  ponds,  estuaries, oceans or public waters unless
        this product is specifically identified and addressed in a National
        Pollutant Discharge Elimination System (NPDES) permit.  Do not
        discharge effluent containing this product into sewer systems
        without previously notifying the sewage treatment plant authority.
        For guidance,  contact  your State Water Board or Regional Office
        of  the Environmental Protection Agency."

In addition to the requirements stated in 40 CFR « 162.10, the following in-
formation  must appear on the  labeling  of MUPs, EUPs, and mixtures where
alachlor is contained in one  of the products.


    1. Hazard Information

       Itie following  statements must be presented in a prominent place at the
       beqinina of supplemental labeling booklets during the 1985 season and
       must he contained in a prominent location on the label affixed to any
       products marketed after  the 1985 season.

         "The use of  this product may  be hazardous to your health,  this
         product contains alachlor, which has been determined to cause
         tumors in laboratory animals."

         "Users are urged to obtain information on careful handling and use
         of pesticides and to participate in [Name of Registrant for MUP
         contained in product] educational program on potential hazards and
         safer use of this product.  For additional information, contact
         [Registrant]  at  1-800-XXX-XXXX."

    2. Additional Warnings and Use Instructions

       The following statements must appear in appropriate sections of the
       labelling of products containing alachlor.
                                    11

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Water Contamination Warnings

"This chemical has been identified in limited ground water sampling
and there is the possibility that it will leach through the soil to
ground water, especially where soils are coarse and ground water is
near the surface.  Following application and during rainfall events
that cause runoff, this chemical may reach surface water bodies,
including streams, rivers and reservoirs."

Instructions Relating to Water Contamination

  "Care must be taken when usinq this product to prevent back sip-
  honing into wells, spills or improper disposal of excess pesticide,
  spray mixtures or rinsate."

  "Check valves or antisiphoninq devices must be used on all mixing
  and/or irrigation eouipment.  Disposal of excess pesticide, spray
  mixtures or rinsate should be according to label use instructions
  or according to the state pesticide or environmental control agency
  or the hazardous waste representative at the nearest EPA regional
  office."

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

Instructions to Reduce Applicator Exposure

  "HANDLING INSTRUCTION FOR TRANSFER, MIXING, CLEANING AND
  EQUIPMENT REPAIR"

  "Note: Direct contact or exposure to Lasso* or spray mixtures of
  Lasso should be minimized. The following instructions for transfer,
  mixing, cleaning or repairing equipment should be followed in order
  to minimize this exposure.  Review the protective clothing require-
  ments as listed in the Precautionary Statements section of this
  label (front panel) and do not use this product until you have the
  necessary protective clothing."

    2.5 Gallon Containers

  "Open pouring from these containers can result in exposure from
  splashing or spilling.  Special care in lifting and pouring are
  strongly recommended."

    55 Gallon and Bulk Containers
  "Open pouring from these containers can result in exposure from
  splashing or spilling and is not reconnended.  This product
  should be transferred from these containers to the mix or spray
  tank using pumps or transfer probes.  The probe or pump should
  not be removed from the container or disconnected until the  •
  container is emptied and rinsed.  Dse the pump or probe system to
  rinse the empty container and transfer the rinsate directly to
  the mix or spray tank."

                           12

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  Equipment Cleaning and Repair

    "CLeaninq and repair of transfer systems and application equipment
    is a source of exposure to this product.  Care should be taken to
    minimize exposure during cleaning and repair of transfer sysytems
    and application equipment.  Vtienever possible, these systems or
    equipment should be rinsed before beina cleaned or repaired.
    When repairs must be made during transfer or application, the
    equipment should be shutdown and special care taken to avoid
    contact with the oesticide."

Protective Clothing Requirements

  "Wear goggles or face shield, rubber gloves, lona trousers, long
  sleeved shirt or jacket of tightly woven material along with boots
  hiah enouah to cover ankles when transferring and mixing and when
  adiusting, repairing or cleaning equipment.  Wear rubber boots
  when pourring from open containers, or when reentry is made into
  fields where the product has been applied through sprinkler
  irrigation systems."

  "Any article worn while handling alachlor must be cleaned before
  reusing.  Clothing which has been drenched or has otherwise
  absorbed concentrated pesticide must be disposed in a sanitary
  landfill, incineration or, if allowed by state and local autho-
  rities, by burning.  If burned, stay out of smoke."

Prohibition on Aerial Application

  "Do not apply with aerial equipment."

Directions for Use in Center Pivot Irrigation

  "For users of irrigation equipment such as the center pivot system,
  refer to the producer's technical bulletin on that method of
  application."

Application Rates

  The highest permitted label rate for soybeans must be 4 Ibs/acre.

  The instructions related to label rates must include the following
  statement:

    "Applicators should evaluate soil and weed conditions carefully
    to ensure that they choose the lowest effective application
    rate."
                           13

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H.  OTHER REQUIRED AMENDMENTS TO REGISTRATION TERNS AND CONDITIONS

    1. Training/ Information Program

       Registrations for manufacturing-use products must contain the  following
       conditions of registration:

         a. The registrant of each MUP must develop and implement an  on-qoinq
            program of information and training aoproved by EPA and designed
            to be readily available to all users of alachlor products prior
            to use of those products during the 1985 season.

         b. MUP registrant(s) must submit to EPA all training materials and
            a statement of plans to ensure availability of  the  program to
            users and to ensure that users are aware of its availability.
            Submittal of materials and incorporation of EPA required  modifi-
            cations must be completed by a time which permits full implemen-
            tation prior bo the 1985 use season.

         c. Acceptable training materials must meet the following criteria:

            1) Adequacy and accuracy of statements  regarding toxicity of
               alachlor and exposure to alachlor through handling and water
               contamination,

            2) Adequacy and accuracy of statements  describing the labeling
               changes required in  the Registration Standard,

            3) Balance and objectivity,

            4) Avoidance of promotional  content in  the  training materials,

            5) Consistency of the training materials with Agency accepted
               scientific principles.

        d.  Acceptable plans to make the orogram available  to users must
            meet  the following criteria:

            1) Convenience of availability bo users, including  appropriate
               scheduling and  location,

            2) Ready availability of training materials  for use by the
               USDA Extension  Service, state  and  local government entities,
               or other appropriate  bodies,

            3)  Adequate public information  campaign to direct users bo the
               program.

        e. MUP registrant(s) must contract with  a competent independent
           entity  in  the manner prescribed here.  The terms of  the contract,
           with  the exceptions of terms  solely to establish amounts of
           compensation, shall be provided to EPA.
                                   14

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             The contract terms shall include the following  responsibilities
             to he executed solely by the contractor or  its  independent sub-
             contractors:

             1) Appropriate independent,  anonymous assessment of actual train-
                ing presentations designed to assess their objectivity and
                effectiveness,

             2) Independent assessment of the percentage and type of users
                reached by the program,

             3) Development of appropriate criteria to measure program effec-
                tiveness/

             4) Reporting directly to a designated EPA coordinator of the
                results of (1) and (2)  above,  at  quarterly intervals begin- ,
                ning April 1,  1985.  Reports  to EPA must be  made prior to or
                at the same time as such  reports  are supplied to the
                registrant,

             5) Submittal to EPA of the criteria  developed in (3) above,

             6) Following acceptance by EPA of criteria  developed throuqh (3)
                above, assessment of program  effectiveness,

             7) Reportino directly to EPA of  the  results of  (fi) above, at time(s)
                established by EPA.  Such reports to EPA must be made prior to
                or at the same time as they are supplied to  the registrant.
I.  TOLERANCE ASSESSMENT

The Agency  is unable  to complete a  full  tolerance reassessment because of
certain residue chemistry data gaps.  The additional residue data will be
used  to more fully assess dietary exposure to alachlor and may lead to
revisions in the existing tolerances.

The estimated oncogenic risk levels for  persons exposed through consumption
of treated  earnedities,  consumption of contaminated drinking water and
occupational contact  with alachlor  will  be presented in the Special Review
document.

In the United States, tolerances are currently established in 40 CFR S 180.
249 for the combined  residues of the herbicide (2-chloro-2l-6'-diethyl-N-
(methoxymethyl)acetanilide) and  its metabolites [ measurable only as those
containing  the 2,6-diethylaniline moiety (calculated as alachlor)] in or on
the raw agricultural  commodities listed  below:
                                    15

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Cornedities                               Parts per million

Beans, dry                                0.1
Beans, forage                             n.2
Beans, lima(green)                        0.1
Cattle, fat '                             0.02
Cattle, meat by-products                  n.02
Cattle, meat                              0.02
Corn, fodder                              0.2
Corn, forage                              0.2
Corn, fresh, {sweet)(K+CWHR)              0.05
Corn, grain                               0.2
Cotton, forage                            0.2
Cottonseed                                0.05
Eggs                                      0.02
Goats, fat                                0.02
Goats, meat by-products                   0.02
Goats, meat                               0.02
Hogs, fat                                 0.02
Hogs, meat by-products                    0.02
Hogs, meat                                0.02
Horses, fat                               0.02
Horses, meat                              0.02
Milk                                      0.02
Peanuts                                   O.OS
Peanuts, forage                           3.0
Peanuts, hay                              3.0
Peanuts, hulls                            1.5
Peas, forage                              0.2
Peas, hay                                 0.2
Peas, pods removed                        0.1
Potatoes                                  0.1
Poultry, fat                              0.02
Poultry, meat by-products                 0.02
Poultry, meat                             0.02
Sheep, fat                                0.02
Sheep, meat by-products                   0.02
Sheep, meat                               0.02
Sorohum, fodder                           1.0
Sorqhum, forage                           1.0
Sorqhum, grain(milo)                      0.1
Soybeans                                  0.2
Soybeans, forage                          0.75
Soybeans, hay                             0.2
Sunflower seed                            0.25
                                16

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II.  REQUIREMENT FOR SUBMISSION OF GENERIC DATA

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

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

   B.  What Generic 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 registrability of all
products, and the dates by which the data must be submitted.
The required studies must be conducted in accordance with
EPA approved protocols  (such as those contained in the Pesticide
Assessment Guidelines 2/ or data collected under the approved
protocols of the OrganTzation for Economic Cooperation and
Development (OECD).  If you wish not to develop data which
are necessary to support the reregistration of certain uses
appearing in your labeling, you may delete those uses at the
time you submit your revised labeling.

     Also for certain kinds of testing (generally ecological
effects), EPA requires  the test substance to be a "typical
   I/ Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient (or all such
products having a certain use pattern), regardless of any such
product's unique composition or use.  Product-specific data relate
only to the properties or effects of a product with a particular
composition (or a group of products with closely similar composition).

   2/ The Pesticide Assessment Guidelines are available in hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va.  22161.
                               17

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 formulation,  and  in those cases EPA needs data of that type
 for each major formulation category (e.g., emulsifiable 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 formulations0 but
 not others.  Motet  The "typical formulation" data should
 not be confused with product-specific data (Table B) which are
 required on each formulation.  Product-specific data are
 further explained  in Chapter 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 "PIFRA
 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.

    3.  File 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-4)V

                              OR
     V FIFRA sec. 3(c)(2)(B) authorizes joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
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)
                              18

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     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 registration(s)
     of your products for which the data are  needed.   (This option
     is not available to applicants for new products.)

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

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

      If you think that you will need more time to generate the
 required data than is allowed by EPA's schedule, you may
 submit a request for an extension of time.   The extension
 request must be submitted in writing to the  Product  Manager.
 The extension request should state the reasons why  you  conclude
 that an extension is appropriate.   While EPA considers  your
 request,  you must strive to meet the deadline for submitting
 the required data.
 (Footnote  continued  from previous page)
        In  EPA's  opinion,  joint data development by all registrants
who  are subject  to the  requirements to submit a pertinent  item
of data or a  cost-sharing agreement among all such registrants
is clearly in the  public  interest.  Duplication of testing could
increase costs,  tie  up  testing facilities, and subject an unneces-
sarily  large  number  of  animals to testing.

      As noted earlier,  EPA  has discretion not to suspend the
registration  of  a  product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B).  EPA has concluded that
it is appropriate  to exercise its discretion not to suspend in
ways which will  discourage duplicative testing.  Accordingly, if
(1)  a registrant has informed us of his intent to develop and
submit  data required by  this Notice; and (2) a second regis-
trant informs  EPA  that  it has made a bona fide offer to the
first registrant to  share in the expenses of the testing [on
terms to be agreed upon or determined by arbitration under FIFRA
Section  3(c)(2)(B)(iii ) ];  and (3) the first registrant has declined
to agree to enter  into a  cost-sharing agreement, EPA will not
suspend  the second firm's registration.
                              19

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                       Sft 2hd«c to Pesueide Chemicals

                                 AIACHIOR*                                  090501
TYPE PESTICIDE:  Herbicide

POSMILAnONSt    Tech (60%,  90%), 6 (9%, 10%. 15%), C.(2.6 lb/gal, 4 lb/gal),
--     PIC (2.5 lb/gal).
GENERAL IHFORMflTONi  A preenergent herbicide with a soil  persistence of 6-10
""""""""^^————  %jeeka  in mediun to fine soils and less in low organic
                      or sandy soils.

TIME RECDTRZD FOR CPOTRDLi   (Itot located).

              TO TABSET WEIDSt  General
tODEOP ACTION:  Inhibition of protein synthesis; inhibition of root elonga-
                 tion*
— .~--~* TOLERANCESi  0.02 ppn (negligible residue) in milk,  eggs, and the
neat, fat, and neat byproducts  of cattle, goats, hogs, horses, poultry, and


BRQACLEAF WEEDS CEtTTRXLEDi
  blade nightshade                (•)                                        PBAIBE
                                                                            BMAB8A
         lanfeequarters            (b)                                        SBCMRA
  cannon purslane                                                           PECAEBA
                                  (b)                                        BFAZBA
                                  (b)                                        PCCAtBC
  Florida pusley
  galinsoga                                                                 P3FBCAA
  hairy nightshade                (a)                                        P9PJBG
  ladysthunb                      (b)                                        PEAASP
  Pennsylvania snartweed          (b)                                        PEAAQSO
  prickly sida                    (b)                                        PDAAJBF
  redrcot pigweed                                                           PAFMSI
  2-chloro-2'. 6'-diethyl-{r-{inethaxyBethyl)  acetanUide
 Zssuads  3-1-82                    20

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                        EBt Bidet *» Sesticide Oionicala
GRASSES AND OTHER HaUOCTS CCt/i'HULLED*
  barnyerdgrass
  broadleaf aignalgraa*                                                    FOARBD
  Oftnchrui pauciflorui            (b)                                       FCAWBF
   fall panieun                                                             POCBBD
(seedling)         (b)
   Jchnaong:
   ara« en
  rice
  rdbuat purple fartail                                                    FC7CIBZ
  rcteust vhlte fartail                                                     FUCDRB
  •oooth crabgraaa                                                         FCABEBD'
        panicua                   (d)                                       KfCSL
  yelln
  yellow nutsedge                 (e)
a)  Tnlnimm of 2.5 Ibe

b)  reduced cotpe+dtion only %hen applied preplan* Incorporated or pr
    %dthia 5 day* of last tiUage at  2.5 - 4.0 Ib ai/fe

e)  ct 3-4 Ib ai/A for control vhen applied preplan*, incorporated; or for
            ccnpBtitioa vhen applied  preeBerjense to the the toil •xarfaca;
d)  min-hnm of 3 Ib ai/A by center pivot irrigation on corn far reduced
Ziiuedx  3-1-62

                                  21

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                        ES& 2hdex to Pesudde Chemicals
                                   AUCHD3R
 Site. Desaoe             Tolerance. Use, Linritati
 and Formulation
     A.1./AJ

  jKlCLJUJKAL
  ttoere a dosage range is given,  use the lower end of the range on
  •alls ; use the higher end of the range OB fine soils . or for control
  of hard-to-control weeds, or there heavy wed infestations are eA^ec'.*!
  Beans, Dry             04 ppn (negligible residue) (beans)                 15001AA.
                         0.2ppa (negligible residue) (forage and hay)

    2.5-3.0              OM limited to west of ths Mississippi River,
    (4 Ib/gal E)        except in Kara County, California.
                         Breplant incorporation.  Beoadcast.  Apply and
                         incorporate uniformly into the top 2 inches of
                         soil within 7 days prior to planting.  In the
                         absence of adequate moisture for herbicide activa-
                         tion irrigate within 7 days after application.
                         My be tank mixed with trifluralin.

    2.0                  DM limited to NZ. . Rreplant incorporation.
    (4 Ib/gal E)        Broadcast. Apply and incut Curate uniformly no
                         deeper..than ffe top 2 inches of soil within 7 days
                         prior  td'planting.  to not use on sands or lossy
                         sands.   Hallow with a sequential, preonergenee
                         application of chloranban, or dinoseb, altanolanins
                         salts of the ethanol and isopropanol series.

  Beans, Lima            0.1 ppn (negligible residue) (beans)                 15002AA
                         0.2 ppm (negligible residue) (forage and hay)

    2.5-3.0              Die limited to west of the Mississippi River,
    (4 Ib/gal E)        except in  Kern County,  California.
                         Preplant incorporation.  Broadcast.  Apply ani
                         incorporate uniformly into the top 2 inches of
                         soil within 7 days prior to planting.  3h the
                         absence of adequate moisture for herbicide activa-
                         tion irrigate within 7 days after application. .
                         toy be tank mi-mi with trifiuralia.
Issued:   3-1-82
                                   22

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                         S&  Index to Pesticide Oiemicals
 Site, Dosage            Tolerance, Use, Limitations
 and Forauilation         ——————^—^^^—
  Beans,  Hung           0.1 ppn (negligible residue)  Cbeans)                 13012AA
                         0*2 ppn (negligible residue)  (forage and hay)
     1.5-2.0             Die limited to GK  Rreanergence*  Broadcast or
     (4 lb/gai  E)        band.  Jfcply within 5 days of the last tillage
                         textured (except sand)  soils, and the higher
                              le en mediua or fine textured soils.  CD not
  Beans, Red Kidney     0.1 ppa (negligible residue)  (beans)                 15001AA
                         0.2 ppoi (negligible residue)  (forage and hay)

    2.5-3.0             Dee limited to WZ.  Freplant incorporation.
     (4 lb/gal BC)        Broadcast or band.  Apply and incorporate
                         unifbsnly into the top 2 inches of soil within 7
                         days prior to planting.   In the absence of adequate
                         moisture far herbicide activation irrigate within
                         7 days after application.
    2.5-3.0             Cse-lirai*eai±D-WI.  Fteemergence.  Broadcast or
     (4 lV?al HZ)        band.  Jfcply within 5 days of the last tillage
                         0.05 ppn (fresh com including  sweet corn Oeernels   28005tA
                                   plus cob with husk rowed)
                         0.2  ppm (fodderf  forage* grain)
                         General Bifocnationt  ^ply sprays in 15 or more
                         gallons of water or sprayable fluid fertiliser par
                         acre.  Da not apply in fluid fertilizers after crop
                         emergence.  Alachlor alone  or in mixture with
                         atrazine may be applied preqnergenee by center
                         pivot irrigation systems.   This type of application
                         should be made in  0.33 to 0.75  inch of water per
                         acre; on very sandy soils apply in a max&iun of 0.5
                         inch water per acre.  Alachlor  alone or in mixture
                         with atrazine may  be applied aerially in 3 gallons
                         of water per acre.  Alachlor in mixture with
                         2-( (4<
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                            fiidex to Pesticide Oiemieals
Site, Dosage            Tolerance. Use, Limitations
and Porrmilation
Tib
  Corn (continued)        mixture with atra^iner or 2-((4^hlaro-€-
                         (athyi amino)-s-tr iazin-2-yl) anino)-2-methyl"
                         propionitrile and applied; the impregnation
                         cess oust be dene at conuereial fertilizer or
                         chemical dealerships eqoipped for this proce-
                         dure.

    2.5-4.0              Preplant incorporation.  Broadcast or band.
    (4 It/gal E)

    2.5-3.5              Preplant incorporation fcr furrow irrigated
    (4 Ib/gal S)         Broadcast.  Apply and incorporate into the top
                         2 to 3 inches of soil within 7 days prior to plant-
                         ing.  Dse a cultipacker or similar type implement to
                         pack the soil fcl lowing incorporation.  Plant
                         ifflnediately after packing.  SDil moisture at
                         application in this 2-3 inch aana most be
                         sufficient fcr crop and weed emergence.  &rigation
                         within 10 days following planting nay
                             control.
    2. 5-3. 5             Use Ilifllted~to OK and T5C.  Preplant incorporation
    (4 Ib/gal E)        fcr when corn is planted dry and watered-ip.
                        Broadcast after prepared beds are knocked off
                        to  planting height.  Ti* *i'^ p?r^*^ into the top 2
                        inches of soil with a rolling cultivator or
                        similar izr^lenent within 7 days prior to planting.

    2.0-3.0             Preplant incorporation.  Broadcast.  Tank mix with
    (4 Ib/gal S)
    2.5-3.0              Preplant incorporation.  Broadcast.  Tank mix with
    (4 Ib/gal E)        2-( (4-
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                            Tnisx ra Pesticide Oiemicals
                                   AUCSLDR
Site, Dosage             Tolerance. Use. Limitations
anT
    aTWAj

AGRICULTURAL CHOPS

  Com (continued)

     .0-4.0              Preemergence.  Apply to the aoil surface after
     4 lb/gal ZC)        planting, but before weeds and crop •nerge and
                         within 5 days after  the last preplan*, tillage
                         operation.   DBS a miniimn of 3.0 Ib ai/A when
                         applying through center pivot irigation
    1.5-2.5              Peeemergence.   Broadcast.  Tank mix with atrazine.
    (4 lb/gal EC)        Use a minima of 2.0 Ib ai/A vfcen applying through
                                pivot irrigation systems.
    2.0-2.5 %            Preamergence.   Broadcast.  Co not apply to sands
    (4 lb/gal EC)        with less than 2% organic matter.  "BsnJc mix with
                         2-( (4-chloto-6-( ethyl amino-s-triari n-2-yl)amino)-
                         2-^nethyipropionitrile.
    2.0-4.0              Early postemergenee.  Apply to the soil surface
    (4 lb/gal O        after crop emergence  until the crop is no more than
                         3 inchea tall,   applications more than 5 days after
                         last tillage operation must be followed innediately
                         with rotary hoe or shallow cultivation to remove
                               which are,geminated and near emergence.
    1.5-2.5              Early postemergenee.   Broadcast.  Apply befcre crop
    (4 lb/gal EC)        is 5 inches tall.   Co not apply on sweet corn.  Tank
                         mix with atrazine.
    (field coin, hybrid seed com*  silage corn, sweet corn)

    2.19-3.13            Preplant incorporation.   Broadcast.  Apply and
    (2.5 lb/gal PIC)     iuuui.tjua.-ate into the top 2 inches of soil within 7
                         daya prior to planting,   formulated  with atrazine.

    2.25-3.13            Preplant or preemergence.  ..Broadcast.  EOT use in
    (2.5 lb/gal F1C)     minima tillage systems.  Sank mix with glyphoeate,
                         isopropylamine salt; or  paraquat dichloride.  Apply
                         in 20-60 gallons of water per  acre by ground eqiiip-
                                Xoxsulated  with atrazine.
Xsauedi  3-1-82

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                        ZSft Index -» Pesticide Oienicals
                                    AUC3U3R
 Site. Dcsace            Tolerance, Use, Limitations
 and Focmlation         ~~~~~""~""~~1~~~"~^^^~~~"~

 AOUCUUTURAL OOPS

  Corn  (continued)

     2.4                 Freemergence.  Broadcast or band.  Xbr lister
     (15% G)              or deep furrow planted corn.  If heavy rains
                         fallow application, weed control on the top
                         and sides of the furrow may not be as good as that
                         in the bottan of the  furrow.  2h deep lister
                         plantings only partial control can be expected on
                         the steep furrow sides.  It is suggested that a 7
                         inch band be applied  at the bottom of the furrow.
    2.4—3.9              Frflemergence 11 >.*OL po* a LI on for furrow irrigated
    (15% G)              corn,  Apply and incorporate with a harrow, finger
                         waeder or rotary hoe into the  top 0.5 to 2 inches of
                         soil.  Incorporation depth must be kept above the
                         seed.  Sail moisture at application must be sufficient
                         far crop and waed emergence,   irrigation within 10
                         days following planting may improve veed control.

    (field corn, hybrid seed corn, silage corn)
    2.O-2.5              Preemergenoe*  Broadcast or band.  Xbr lister or
    (20% G)              deep furrow planted corn.   If heavy rains fallow
                         application* weed central en the top and sides of the
    2.43                 furrow nay not be as good as that in the bottom of
    (9% G)               the furrow.  Jh deep lister plantings only partial
                         control  CTn be expected en  the steep furrow sides •
                         It is suggested  that a 7 inch band be applied at
                         the bottcra of the furrow,   tfey be fboulated with
                         atrarine.
    2.0-3.5              Preemergence incorporation for  furrow irrigated corn.
    (10% G)              apply and 
-------
                        S& Index to Pesticide Qiemicals
 Site, Dosage            Toleranea> Use, Linitati
 and Fonmlation
 (ib
            dnued)

    2.25-3.13            ttrly postemergence.  Broadcast or band,
     (2.5 Ib/gal PIC)     up until the crop reaches 5 inches in height.
                         Zbsnilated with atrazine.

    (field earn aid silage corn)

    2.5-4.0             Prepiant or premergence.  Broadcast in 15^0
    (4 Ib/gal E)        gallons of water per acre.  Rv use in minima
                         tillage system. Jfey be tank mixed with
                         glvphosata, iaopropylamine salt; or atrazine and
                         paraquat dichloride for control of emerged weeds;
                         or with atrazine; or 2-{ (4-chloro-6-(a*hylanino)-
                         s-triaa±n-2^1)amino)-2-«e*hyipropionii»xile; or
                         staazine for preeitezgent %«ei control.  Glyphoeate,
                         iaopropylanine salt may be added to the latter three
                         preesezgent vwed control tank mixes to expand
                         control to include  emerged weeds.

    2.5                  OM TtirrUfrt.fln fiat-planted field corn in II. ZA. MN.
    (4 ib/gal S)        and  WI.  Freatnergence  or early poetemergence.
                         Breadeast.   ^pply after planting and be fere the crop
                         is 3 inches tall.  If rain does not occur within 3
                         days after  an early postonezgence application* rotary
                         hoe to control emerged  vceds.  Cae on fine taxtured
                         soils only,  lank mix with dicartoa.

                         A sacpen^ial poetemergent directed application of
                         2«4-dichlorophenoxyacetic acid (low volatile esters
                         amines) may follow  alachlor applications.

                         0.05 ppn (negligible residue) (cotton seed)          28007AA
                         0.2  ppa (negligible residua) (forage)
                         General 3hfcnnation:  ^pply in 15 or more gallons
                         of water per acre.  CD  natr use on sands.  Do not
                         replant within 6 weeks of application in soil
                         broadcast treated with  alachlor.  If replanting is
                                  in band treated fields, replant in un-
                                  9il;  for furrow planted cotton, open new
                         furrows and plant in soil not previously treated.
                         If sprinkler irrigation is used, irrigate before
                         planting, plant into moisture and apply.  After
                         cotton has  emerged  and  is growing wall, sprinkling
                         may be done as needed.


Issued:  3-1-82
                                  2?

-------
                        S& Index *D Ftsticide Oiemicals
                                   AXACELCR
Site. Doaage            Tolerance. Use. Liadtati
and Fcnrailation
(Ib a.i ./A)
  Cotton (continued)

    1.0-2.0             Use limited to OK and certain TX counties.
    (4 lb/gal E)       Breemergence.  Broadcast or band.  Apply within
                        5 days after last preplant tillage operation.
                        Delay of application until cotton Healings have
                        geminated but not emerged through the soil sur-
                        face may reduce potential flbr crop injury.  If
                        a band treatment is used the spray nozzles must
                        be  located behind the drags or the covering
                        mechanism of the planter.

  Peanuts               0.05 ppn (neglible residue) (peanuts)               28015A&
                        1.5 ppn (hulls)
                        3.0 ppn (forage and hay)
                        General Ih&rmatioiu  Apply sprays in 15
                        gallons of %
    3.5-4.0             Preplant or postplant.  Incorporation.  Apply
    (4 lb/gal E)        within 7 days prior to planting up to inmadiately
                        after-pi anting.  Siallowty inmipuia'je into the
                        upper  1-2 inches of soil prior to crop germination.
                        ^3^^SCQn30^^&^M^3Q 9^K QjQ^t FQ^*^3TaTkflRQ0Q ^3K^ ^^^B ^•'^30^^98
                        soils of the southeastern states.

    3.0-4.0             Preemergenee.  Broadcast or band.  Apply within
    (4 lb/gal E)        5 days after the last preplant tillage operation.
    2.0-4.0
    (10%G)

    3.0-3.9
    2.0-4.0             Preemergenee to cracking stage.  Broadcast or
    (4 It/gal S)        band.  Apply innediately after planting until
                        the majority of the peanuts reach the cracking
                        stage,  this is normally 5-7 days after planting.
                        D9 not cultivate be&re applying.  Delaying
                        application until cracking tine will frequently
                        improve weed control.  Tank mix with sediua
                        S-1-naphthyiphthalanate and sediua dinoseb.
                        This tank mix-tore may be applied as a sequential
                        treatment after application of any labeled
                        preplant  incorporated herbicide.
Xnueds  3-1-82
                                    28

-------
                        ESt, Bides  to Pesticide Chemical a
Site, Dosage
and Formulation
(ID a.i./Aj
Tol
. Use, tigdtatiens
        TORAL CRQE5
  Peanuts (continued)

    3.0-3.0
    (4 Ib/gal C)
  Pcaa, Gi
  (for processing)
    2.0-2.5
    (4 Ib/gal
    2.5-3.0
    (4 Ib/gal S)
QraeJdng stag*.  Broadcast or band.  lank
with dinoseb, aUcanolamina salts of the ethanol
and isopropanol series:.  CO not add watting
agoots or other adjutants to this miztir*.
0.1 ppn (negligible readdue)  (peas vdth pads
        (dateznined on peas after ranoving any pod
                                           1SDOAA
0.2ppa (negligible residue)  (farage aid hay)

Ose limited to Won peas gxowi fbr processing.
Breonergenea.  Broadcast,  flpply in 15 or more
gallons of %a4er per acre within 5  days after
last prcplant tillage operation,  fay be applied
aerially in 3 gallons of
OJ. ppn (negligible residue)
General" 2nS~xnations  Apply in 15 or more
gallons of water per acre.  Machlor alone or in
mixture with 4^araino-6-(l,l-dJme*3iylethyl)-3-
(nethylthio)-l, 2,4-
-------
                        S& 2fcdex to Pesticide C*.enieals
Site. Dosage
and Formal axicn


jySCCULTlUAL vStJtS

  •^^fc^U^^^^^fc f.^K^^^B^^J ^^^^b^\
  anbTCeV^O CGGR^2J*uBQJ


    2.0-3.0
    (4 Ib/gal E)
                         Tolerance. Use,  Limitations
    2.0-3.0
    (4 Ib/gal E)
    2.0-3.0
    (4 Ib/gal E)
D§« limited to fedoc and SlsJdjou Oaunties,  A and
all other states except the Bad River Valley areas
ef m and HD.  Freemergence.  Broadcast or bend.
feply after final drag-off or after early hilling
if these practice* are used,  (fee the higher rate
when applied through center pivot irrigation.  Oka
the lower rate In the New ftgland states including
KD aad PA northward or ia other areas where  cold,
wet conditions are litely to persist,  lank  mix
with 4-anino-&-(l,l-d±Bethylethyl)-3-(nethylthio)-
1 , 2. 4-*riazin-5 (4R >-cne.

Gee limited to all states except CA, ID,  OR, WA
and the Red River. Valley areas of W and HD.
Rreonergence.  Broadcast or band,  Jfeply after
final drag-off or after early hilling if these
practices are .used.  Eb not use on sands or  on
soils with less than 1% organic matter,  lank  mix
with linuron.

Use limited to those states east of the Mississippi
River,  ffceaoergence.  Broadcast or band. DD  not
applywuntil-after final drag-off.  CD not use  on
sands, on soils with less than 1% organic wetter ,
or  when potatoes are grown under furrow irrigation.
lank mix with direseb, alkanolaaine salts of the
ethanol and isopropanol series.

0.2 ppm  (negligible residue) (soybeans)
0.75 ppm (forage) .
General Information*  Apply sprays in 15 or  more
gallons of water or sprayable fluid fertilizer per
acre* Machlor alone or in mixture with linuron;
or chloitttunurcn; or 4-aminD-6-(l,l-dJmethyie4iyl)-
3-phthalaaic acid and
                        ecdiuB dlnnefb may be applied aerially in 5 gallons
                        ef water per  acre.  DD not apply aerially in mini-
                        ma tillage systems,  try bulk fertilizer may be
                                    with alachlor alone or in mixture vdth
                        4-aBino-6-(l« 14iaethylethyl)-3-(methylthioM. 2
                        triaxin-5(4H}-one and applied; tha |mpre?nation
                        cess must be dene at ceamercial fertilizer or chemi-
                        cal  dealerships equipped for this procedure.
2ssueds   3-1-82
                                   30

-------
                             Index to Pesticide Qiemicals
 Site,  Dosage
 and Fonaulation
 llto a J../A)
    JCULTVJRAL CSDES

  Soybeans (continued)

    2.5-4.0
     (4 It/gal  C)
     2.0-2.4
     (4 Ib/gal HZ)
Tolerance, Use. Limitations
    2.11-3.25
    (2.6 Ib/gal E)
    2.0-3.5
    (1016)

    2.4-3.9
    2.0-3.5
    (10% 6)

    2.4-3.9
    (15% G)
    2.0-4.0
    (4
Freplant.  Incorporation.  Broadcast or _
Apply within 7 days prior to planting and
incorporate into the top 1-2 inches of  soil.  ._,
be tank mixed with 4-aaino 6 (1,1-dfaethylethyl)-
3-(nethyithio) -1.2,4-triazln-5 (4R }-cns.
gallons of «ater per acre,  for use in mininun
tillage system.  My be tank mixed %dth
gl^phosata* isopropylanine salt; or lintroa and
PL aqiat dichlorioe; or 4-anino-6-(l,l-d±i»rt3iyl»
ethyl) -3-(methyi tMo) -1,2.4->riazin-5 (4H )-one
and glyphosata, isopzcpyiaBine  salt.
Wb planting or preonergeoee.  droadcast.  Ibr use
in mininun tillage systaas.   ^pply in 20-30 gallons
of %ater by ground eqiipneat.  lank mix vdth 4-onine
6-(l,l-dinethylethyl)-3-(inethylthio)-l« 2,4-*riazin-
5(4H)rone; or 1-iniaren. .!baviated with glyphosats*
isopcopyiamlne salt.
     lergence.  aroadcast or band.
                      ra uon.
       k^ajuv*  ,nwu&£
-------
                       S& Index to Pesticide Giemicals
                                   ALACSZO5
Site, Dosage            Tolerance. Use, Limitati
and FcBiulation
(ib a a./A
  Soybeans (continued)

    2.0                 Preemergence.  Broadcast or bend,  J£ply within
    (4 Ib/gal E)       5 days after last preplant  tillage operation.
                        Tank mix with aodiun dinoeeb  and sodiun N-l-
                        naphthylphthalaaic acid.

    1.5-4.0             Preemergence.  Broadcast or band,  ^ly within
    (4 Ib/gal E)       5 days after last preplant  tillage operation.
                        Tank mix with linuron.
    1.5-2.5             PreoBergenee.  Broadcast or band.  Xpply within
    (4 Ib/gal E)        5 day* after last.preplant tillage operation.
                        Tank mix with chlorbroauton.
    2.0-3.0             Preonergenee.  Broadcast or band,  ffcy also be
    (4 Ib/gal E)        used to oontrol merged weeds and waeis that will
                        germinate later in fields prepared for planting
                        several weeks earlier.  Tank mix with dinoseb,
                        alkanolamiae salts of tha ethane! and  isopropanol
    1.5-3.0             ttrly postemerg^ence.  Broadcast or bend,
    (4 Ib/gal E)        after crop and weeds emerge, but before first
                        soybean leaves expand to expose buis.  to not apply
                        if soil surface is very wet.  Tank mix with diroseb,
                        alkanolamine salts of the ethanol  and isopropanol
                           ries.
                        Sequential treatment of bentaan.   Bentaaon may be
    (4 iVgal E)        applied following prc«nergence aplicaticns of
                        alachlor; or alachlor and linuron; or alachlor and
                        scdiuB d1m>i»h and acdiun W-1-naphthylpnthalanie
                        acid; or alachlor and 4-eulr»^-(l,l-diiiethylethyl)-
                        3-(methylthio)-l( 2.4-triazin-5 («>-cne.
  GZHS9VL XNFCFMAT3DN*   fepeat applications maybe necessary for sustained
  long-tern weed control,  to  not «cc«d 3 applications per year,  to not re-
  treat within 21 days.  Topical applications are not recanmended.   Overhead
  irrigation applied within one hour after treatment will minimi a any
  potential injury caused by accidental contact of the crop ^dth the chemical.
  to not use in greenhouses or other enclosed structures.


Issued s  3-1-82
                                   32

-------
                        281 Jhdex to Pesticide. Qiemicals
Situ, Dosage            Tolerance, Use, Limitations
and Foraulation
(Ib a .i ./A)
  Cotaneaster                                                               34045*
  DC? god                                                                   3S043DA
  Eusnymus                                                                  34053DA
            erabapple                                                       3505€DA
  Yew                                                                       3513GDA

    4.05                 Broadcast to field or liner grew plants in
    (151 6)              netdy planted or established fields.  Apply anytime
                         after transplanting and before weeds enetge, or
                         after existing weeds have been renewed.
  Euonynus               See Gbtoneaster cluster.

  Plowering erabapple    Sae Odtoneaster cluster.

  Holly                                                                     34070DA
  Juniper

    4.05                 Broadcast to^newly planted or established field.
    (151 6)              liner or container grow* plants,  Apply anytime
                         after transplanting and before weeds emerge, or
                         after existing wneis have been razored.

  Juniper                                                                   3S073DA
  Yew                                                                       3513CC*

    4.0                  Directed spray to  newly transplanterl or established
    (4 lb/gal E)         plants.  Apply in  15 or more gallons of veter per
                         acre anytime after transplanting and before weeds
                         enesge.  or after existing vceds have been rsnoved.
                         Do not apply through irrigation systems or nixed
                         %dth sprayable fluid fertilij
                               to ally cluster for additional Juniper infor-
                        mation.

  Yew                   See Gbtoneaster and Juniper clusters.
SMueds  3-1-52

                                     33

-------
                            fiidoc to RestJcide Qiemicals
                                   ftUOOOR
Site, Dosage            Tolerance. Use, Limitations
and Poanmilaticn
(lb a.i./A)

       MO TMK MIX APPLICRTIQC
  Aerial Applications                                                       9001SQ-

    —                   Jfcfer to     	
                         M3KXCUI2URAL OCPS


                                                                            990030
                              to     	
                        KSRTCDLTURAL QCP8
                        B«ans« dry; Beans, Ilmar Oarn? Peanuts, Jbta*»t
Issued:   3-1-63
                                     34

-------
                        B& 2*5**- to Bisticida Qiamlcala
                                    AUCBD3R
 listing of Registered Etosticdda ftoiucts by {boulation.


 60% Technical Chemical
   Alachlor (090501)
     000524-00315

 901- Tee*udcal Chodeal
   Al ashlar (090501)
     000524-00316

 9% Granular
   Alsrhlor (090501) plus Jtrazine (083803)
     000524-00304

 10% Granular
   Alachlor (090501)
     000524-00287

 15% Graxular
  Al ashlar (090501)
    000524-00296

    Ib/gal  Baalalfiable Ceneafrtrata
  Alachlor  (09C501) plu» glyphoin?, iaoprcpylaninc salt (103601)
    000524-00341

4 Ib/gal Bnulsifaable Coneantrata
  ALachlcr  {0*90501j       •
    000^24-00285    000524-00314

2.5 IbAal Ploabla Cencentrata
  Al ashlar  (090501) plus atrazTna (083803)
    000524-00329
Sta*.a Label Regiatrationa

CO Bag. Hb«
  000524-10307
C£ teg. Ib.
  OOOS24-10297
IS
  000524-10303    000524-10304

16 Rag. Bb.
  000524-10286

JS Pag. S3.
  000524-10305

Issued*  3-1-82
                                     35

-------
                       SA Jhdec » Pesticide Cmieals
                                   ALX2LDR
State Label Re&straftienj (ocrrtinuod)
XA
  001339-06934    037820-08430    037820-08431

MO Fag. ».
  CCOS24-10299
  000524-10306    000524-10479
  000524-10301

OH feg. Ito.
  OOOS24-103Q2

ER. Reg. Bb.
  000524-10298

TA Itag. Zb.
  000524-10300
Xssueds  3-1-82
                                   36

-------
 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 FIFRA sec.
 3(c)(2)(B), EPA has determined that you must submit these
 data to EPA in order to reregister your product(s).  All of
 these data must be submitted not later than six months after
 you receive this guidance document.

      "Product-Specific Data Requirements for Manufacturing
 Use Products" appearing in Table B permit you to determine
 which product-specific data you must submit.  This can be
 done by examining the entries in the column of those tables
 entitled "Must Data By Submitted Under S3(c)(2)(B)."
^J Product  specific  data  pertain  to  data  that  support  the
formulation which  is marketed;  it usually includes product
chemistry data  and acute  toxicity data.
                                 37

-------
                                                TABLE A
                               GENERIC DATA REQUIREMENTS FOR ALACHLOR
V
Data Requirement Composition
§158.120 Product Chemistry
Product Identity:
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation of
Ingredients
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density , Bulk Density, or
TGAI
TGAI
TGAI

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

No
No
Partially
No
Yes
No
No
N/A 3/
No
Must Additional
Data Be Submitted
, Bibliographic Under PIPRA Sectioi
Citation 3(c)(2)(B)?
GS0063-0001 No
GS0063-0002 Yes 2/
GS0063-0003 Ye8 2/

Yes y
Yes y
GS0063-0004 Yes 2/
GS0063-0005
Yes y
GS0063-0005 No
Yes y
Yes y

Yes y
Specific Gravity

-------
                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FOR ALACHLOR
I/
Data Requirement Composition
Does EPA Have Data Must Additional.
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Sectioi
No or Partially) Citation 3(c)(2)(B)7
S158.120 Product Chemistry
63- 8
63- 9
63-10
63-11
63-12
63-13
Other
(continued)
- Solubility TGAI
• Vapor Pressure PAI
- Dissociation constant PAI
- Cctanol/water partition PAI
coefficient
- pH TGAI
- Stability TGAI
Requirements t
Partially
No
No
No
No
No

(50063-0005 Yes 2/4/
Yes 2/4/
Yes 2/
Yes 2/4/
Yes y
Yes 2/

64- 1 - Subnittal of sanples
Choice
N/A3/

-------
                                                      TABLE A
                                      GENERIC DATA REQUIREMENTS FOR ALACHLOR

  5158.120 Product Chemistry
           (continued)

I/ Composition:  TGAI = Technical grade of the active ingredient; PAI « Pure active ingredient;  Choice » Choice of
   several test substances determined on a case-by-case basis.
2/ Data must be submitted no later than six months from the receipt date of this guidance package.
3/ N/A- Not required for the purposes of this standard.
4/ Chemistry data are indicated because of Agency's concern for ground water contamination by alachlor*
                                                         LO

-------
                TABLE A
GENERIC DATA REQUIREMENTS FOR ALACHLOR
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ Requirement? (Yesr Bibliographic Under FIFRA Sectii
Data Requirements Comrosition No, or Partially) Citation 3(c)(2)(B)7
$158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants PAIRA Yes
- Livestock PAIRA and plant Partially
metabolites
171-4 - Residue Analytical Method
- Plant residues TGAI and metabolites Partially
- Animal residues TGAI and metabolites Partially
171-4 - Storage Stability Data PAI No
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
0 Beans(dried 6 succulent) TEP Partially
0 Lima Beans TEP Partially
Lima beans TBP Partially
(Forage and hay)
0 Corn
(Field and Sweet) TEP Partially
G50063-0006 ,650063-0037
GS0063-0007
GS0063-0008
GS0063-0009

GS0063-0006
GS0063-0011
GS0063-0010
-

GS0063-0011
GS0063-0012
GS0063-0011
GS0063-0013
(50063-0014
(50063-0011
(50063-0014
(50063-0006
(50063-0015
080063-0011
No
Yes 7/

Yes 3/6/
Yes 6/T/
Yes J/

Yes 3/6/
Yes 3/6/
Yes 3/6/
yey

-------
                                              TABLE A
                              GENERIC DATA REQUIREMENTS FOR ALACHLOR
!/
Data Requirements Composition
SI 58. 125 Residue Chemistry
171-4 - Magnitude of the Residue-
Residue Studies for Each
Pood Use
0 Corn
(forage and fodder) TEP
0 Cotton, forage TCP
(Cottonseed)
0 Peanuts TCP
(forage* hay, hulls)
0 Peas TCP
Peas TCP
(Forage and hay)
0 Potatoes TCP
0 Sorghun(grain) TCP
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Sectioi
No, or Partially) Citation 3(c)(2)(B)7

Partially
Partially
Partially
Partially
Partially
Partially
Partially

GS0063-0006 ,GS0063-0015
GS0063-001 1 , 00028563
GS0063-0007
GS0063-0007 ,(50063-0019
GS006 3-0016 ,GS0063-0033
GS0063-0011
GS0063-0012
GS006 3-0011
Gs006 3-0012
GS0063-0017
00028556,00028558

Yes 3/6/
Yes 3/6/
Yes 3/6/
Yes 3/6/.
Yes 3/6/
Yes 3/6/
Yes 3/6/
0 Sorghum
  (fodder 6 forage)
TCP
Partially
00028557
00068044,00068045

GS0063-0018
Yes J/6/

-------
                                             TABLE A
                             GENERIC DATA
                  FOR ALACHLOR
Data
S158
Requirement
.125 Residue Chemistry
Composition

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

Must Additional
Data Be Submitted
Under FIFRA Sectioi
3(c)(2)(B)7

(continued)
171-4 - Magnitude of the Residue-
Residue Studies for Each










Food Use
0 Soybeans
0 Soybeans
(Forage)
0 Sunflower Seed
- Potable Hater
- Fish
- Irrigated Crops
— Field trials
— Processed Food/Feed
0 Soybean Hulls, Meal,

TEP
TEP
TEP
EP
EP
EP
EP
EP
EP

Partially GS0063-0006
Partially GS0063-0006
GS0063-0012
Partially GS0063-0020
Reserved 4/
N/A 5/
N/A
N/A
-
Partially GS0063-0006

Yes 3/6/
Yes 3/6/
Yes 3/6/





Yes 3/6/
  Oil(crude & refined)
  and Soap Stock

0 Corn Oil and Other
  Processed Products

  Sorghum Grain Processed
  Products
EP


EP
Partially
GS0063-0011
Partially      00068044
               00068045
                                                           Yes
                          Yes

-------
                                                      TABLE A
                                      GENERIC DATA REQUIREMENTS FOR AIACHLOR
Data Requirement
I/
Compos it ion
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Secti<
3(c)(2)(B)7
171-4 - Magnitude of the Residue -
         Residue Studies (continued)
        — Processed Food/Feed
         0 Cottonseed Hulls, Meal,
           Oil, and Soapstock
         0 Peanut Meal, Oil,
         0 Sunflower Meal, Oil,
           and Soapstock
      - Food Handling
      - Meat/milk/poultry/eggs
        0 Cattle
        • Goats
        0 Poultry
        • Eggs
EP
EP

TGAI
TGAI
TGAI
TGAI
Partially
N/A5/

NO
Partially
Partially
Partially
GS0063-0007
GS0063-0021
GS0063-0022
GS0063-0022
Yes 3/6/
EP
EP
Partially
Partially
GS0063-0033
GS006 3-0020
Yes 3/6/
Yes 3/6/
Yes 3/6/
Yes 3/6/
Yes 3/6/
Yes 3/6/

-------
                                                      TABLE A
                                     GENERIC DATA REQUIREMENTS FOR ALACHLOR
<15fl.l25 Residue Chemistry
         (continued)
I/ Composition:  THAI » Technical qrade of the active  ingredient; PAIRA » pure active ingredient, radiolabelled:  TEP •
   Typical end-use product: EP « End-use product.
2/ Data required by this registration standard to be held  in abeyance pending outcome of the Special Review.
J/ Data necessary to maintain registration during the  period of Special Review and any hearings: must be submitted as
   soon as practicable in light of ongoing work and in any case no later than one year from the receipt date of this
   guidance package.
4/ Reserved: Residue chemistry testing for potable water is indicated because of the potential for alachlor to reach
   groundwater.
5/ N/Ar> Not applicable for the purposes of this standard.
6/ Additional metabolism data (submitted with PPt 3F2832 and OP234) reviewed on 4/28/84, and the Special Review
   process indicate the presence of metabolites in plants  convertible to 2-ethylaniline which cannot be measured
   by the present analytical methodology.  Consequently additional residue data and analytical methodology data may
   be required.

7/ The analytical methodology for meat, milk and eqgs  must be submitted in January, 1985.  The registrant committed
   to this date in its letter dated 9/21/84.

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                                                        TABLE A
                                        GENERIC DATA REQUIREMENTS FOR ALACHLOR
Data Requirement
           I/     Use
Composition     Pattern
Does EPA Have Data
To Satisfy This
Requirement?  (Yes,
No or Partially)
  Bibliographic
    Citation
Must Additional
Data Be Submitted
Under FIPRA Section
 3(c)(2)(B)7
S158.130 Environmental Fate

  DEGRADATION STUDIES-LAB;

  161-1 - Hydrolysis

  Photodegradat ion

  161-2 - In water

  161-3 - On soil

  161-4 - In Air


  METABOLISM STUDIES-LABt

  162-1 - Aerobic Soil


  162-2 - Anaerobic Soil
TGAI or PAIRA   A,B,H




TGAI or PAIRA   A,B

TGAI or PAIRA   A

TGAI or PAIRA   A
TGAI or PAIRA   A,B,H
TGAI or PAIRA   A
  162-3 - Anaerobic Aquatic      TGAI or PAIRA

  162-4 - Aerobic Aquatic        TGAI or PAIRA

  MOBILITY STUDIES;

  163-1 - Leaching and           TGAI or PAIRA   A,B,H
          Adsorption/Desorption

  163-2 - Volatility (Lab)           TEP         A


  163-3 - Volatility (Field)         TEP         A
   Yes
   Yes


   Yes


   N/A ID/

   Reserved 4/



   Yes


   Yes


   Yes
GS0063-0036
  No
Yes
Yes
Yes
00023012
GS0063-0036
00091044
GS0063-0038
No
No
•*>
00023014,00101531     No 7/
00100795,GS0063-0036
00100795,00101531
GS0063-0036
  No
                                                  00027139,00078301     No
                                                  00027140,GS0063-0036

                                                  00100075,00101531     No 5/
                                                  00091044

                                                  00101531              No 5/

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                       TABLE A
       GENERIC DMA REQUIREMENTS FOR AIACHDOR
Data Requirement
Composition
  Use  "if
Pattern
Does EPA Have Data
""o Satisfy This
Requirement''  (Yes,
No or Partially)
                                                                                     Bihliooraphic
                                                                                       Citation
Must additional
Data Re Submitted
Under FIFRA Section
  3(c)(?)(B)7
jg.158.130 Environmental Fate
         (continued)

  DISSIPATION STUDIES-FIELD!

  164-1 - Soil

  164-2 - Aquatic (Sediment)

  164-3 - Forestry

  164-4 - Combination and
           Tank Mixes

  164-5 - Soil, Long-term

  ACCtlMULATION STUDIES!

  165-1 - Rotational Crops
            (Confined)

  165-7 - Rotational Crops
            (Field)

  165-3 - Irrigated Crops

  165-4 - In Pish

  165-5 - In Aquatic Non-Taroet
            Organisms

  SPECIAL MONITORING STUDY!

  166-1  - Ground and Surface
            Hater Monitoring
                                     TEP         A,B,H

                                     TEP

                                     TEP

                                     TEP



                                     TEP         A




                                     PAIRA       A


                                     TEP         A



                                     TEP

                                  TGAI  or  PAIRA  A,B

                                     TEP
     TEP
 A,B
                               Yes

                               N/A ID/
                               Reserved 6/
                               Yes
                                Partially
                                    in/
                                YPS


                                NO
                                  00100795,00101531     *>
                                  00023015,00101531
                                  00100705
                                   00087855
                                           NO y



                                           Yes 3/B/5/


                                           Yes V




                                           No

                                           Yes V




                                           Yes ll/

-------
                                                             A
                                      GENERIC DATA REQUIREMENTS FOR AIACHLOR


  S1.5P.130 Environmental Pate
           (continue?)
 i
 I/ OcmDosition:  TGAI * Technical grade of the active ingredient:  PAIRA = pure active ingredient,  radiolabelled?
    TRP = Typical end-use product.
 2/ Tlie use patterns are coded as follows:  A=Terrestrial, Food Crop:  B^Terrestrial, Non-Pood:  OAauatic, Food Crop:
    D=Aquatic, Non-Food: 15=<3reenhouse, Pood Crop;  F=Oreenhouse, Non-Pood:  G=Forestry:  H=Damestic Outdoor; I=Indoor.
 3/ Data required by this registration standard to be held in abeyance pending outcome of the Special Review.
 7/ Aerobic aquatic data have been submitted but previously were not required (Currently in Agency files).
 V itie exposure studies cited, will satisfy data requirements for 161-4: Photodeqradation in Air,  163-2: volatility
    (Lab), and 163-3: volatility (Pield).
 6/ itie requirement for combination and tank mix data is reserved.
 i/ The results of the aerobic soil metabolism study and field dissipation studies indicate that data will n6t he
    necessary.
 8/ Data on j^C uptake by corn seedlings at the four pound per acre rate and on uptake into other crops at the one
    pound per acre rate are acceptable.  Additonal data are needed at actual use rate levels including the
    chemical identification of plant residuest
 9/ For crops rotated on treated areas, any one of the following will apply:
      a. A tolerance must be obtained for the rotated crop,
      b. Ttie product label must include a restriction against the rotation of crops used for food or feed, which are
         not registered for use with alachlor onto areas previously treated with this chemical.
      c. Data must be provided to determine time intervals at which rotated crops used for food or feed, which are not
         registered for use with alachlor but rotated onto areas previously treated with this chemical will be free of
         pesticide residues.  If data are supplied, they must be submitted no later than four months from the
         issuance of this standard.

10/ N/fc* Not applicable for the purposes of this standard.

ll/ A protocol must he designed to study the means and extent of alachlor's potential to leach to ground water and
    of alachlor1 s potential to run off to surface water bodies and to contaminate drinking water drawn from surface
    sources,  itie protocol must he submitted by 90 davs from the issuance date of this standard.

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                                                     TABLE A
                                     GENERIC DATA REQUIREMENTS FOR ALACHLOR
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Sec tier
Data Requirement Composition Patterns No or Partially) Citation 3(c)(2)(B)7
SI 58. 135 Toxicology
ACUTE TESTING!
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Acute Inhalation Toxicity
Rat
- Primary Eye Irritation
- Primary Skin Irritation
- Dermal Sensitization
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B
AfB
A,B
A,B
A,B
A,B
A,B
Yes GS0063-0021 No
Yes GS0063-0022 No
Yes GS0063-0023 No
Yes GS0063-0024 No
Yes GS0063-0025 No
Partially GS0063-0026 Yes 3/
N/A ll/
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
- 90-Day Feeding -
Rodent, Non-rodent
- 21-Day Dermal
- 90-Day Dermal
- 90-Day Inhalation -
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
A,B
N/A
Partially GS0063-0034 Yes 8/ 9/
N/A
N/A
        Rat

82-5 - 90-Day Neurotoxicity-
        Hen/Mannal
TGAI
A,B
N/A

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                                             TABLR A
                             GENERIC DATA RFDniRFMENTS FOR AIACHLOR
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ Use 2/ Requirement? (Yes, Bibliographic Under PIFRA Section
Data Requirement Composition Patterns No or Partially) Citation 3(c)(2)(B)?
5158.135 Toxicology

(continued)


CHRONIC TESTING:
83-1

83-2

83-3

83-4
- Chronic Toxicity - TGAI A,B
2 species: Rat and
Dog
- Oncoqenicity Study - TGAI A,B
2 species: Rat and
Mouse
- Teratoqenicitv - TGAI A,B
2 species: Rat and
Rabbit
- Reproduction, TGAI A,B
2-oeneration
Yes
Partially
Partially
Yes
Yes
Partially
Yes
wrrAGENicrry TESTING
84-2
84-2
84-2
- Gene Mutation TGAI A,B
- Chromosomal Aberration TGAI A,B
- Other Mechanisms of TGAI A,B
Partially
NO
Partially
00064546,00091050 No
GS0063-0027 , GS0063-0028
00028564,000064547 Yes 10/
00087479
00064546,00091050 Yes 4/
00091043,
GS0063-0027,GS0063-0029
GS0063-0028,GS0063-0042
00075709 No
00043645 No
GSn063-0041 Yes V
00075062 No ^ ^j
GS0063-0035 Yes £/ ^ | p
"~~ ° so
Yes6/ 3|3
si
GS0063-0035,GS0063-0043 Yes 6/12/
Mutaqeniciry
                                                50

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                                                        TABLE A
                                        GENERIC DKTA REQUIREMENTS FOR ALACHLOR
Data Requirement
           I/   Use
Composition   Pattern
Does EPA Have Data
To Satisfy This
Requirement?  (Yes,
No or Partially)?
Bibliographic
  Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?	
5158.135 Toxicology
         (continued)

  SPECIAL TESTING

  85-1 - General Metabolism      PAI or PAIRA   A,B

  85-2 - Dcmestic Animal Safety     Choice

  85-3 - Dermal Absorption Study    PAIRA       A,B
  Yes

  N/A ll/

  Partially
                                               GS0063-0030
                                               00091046,00091047
                       No
                       Yes 7/

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                                                       TABLE A
                                      GENERIC DATA REQUIREMENTS FOR ALACHLOR
 S158.135 Toxicology
 I/ Composition!  PAI = Pure active ingredient; PAIRA = Pure active ingredient, radiolabelied;  Choice » dioice of sever
    test substances determined on a case-by-case basis.
 2/ The use patterns are coded as follows:  A=Terrestrial, Food Crop; B=Terrestrial, Non-Food;  G*Aquatlc, Food Crop;
    D=Aquatic, Non-Food; E=Greenhouse, Pood Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; 1=Indoor.
 3/ A skin sensitization study in guinea pigs (Ace.252772, March 1984) has been submitted to the Agency and it is being
    reviewed.
 4/ A new chronlc/oncogenicity study in rats (Part I, Study* ML-80-186) Ace.252496, 252497, 252498,  Feb. 1984)
    has been submitted to the Agency, and it has been reviewed by HED.  * Recently, a full report on rats dosed at the
    126 mg/kg/day dosage level (FJLH-800219, Study* ML-80-224, accessions: I 253306, I2533U7 ) was submitted by the
    registrant.  The Agency has reviewed the study and found it acceptable.
 5/ A teratology study of a second animal species, rabbit (Ace.252570, Feb. 1984) was reviewed by the Agency, and  it was
    found to be supplementary.  This teratology study must be revised in order to fulfill the data gap.
    It is data necessary to maintain registration during the period of Special Review and any hearings; it must be
    submitted as soon as practicable in light of ongoing work and in any case no later than eighteen months from the
    receipt date of this guidance package.
 6/ The following nutagenicity data are required:
      a.  In vitro mammalian cell point mutation [L5178Y (TK), or CHO (HGPRT), or V79 (HGPRT)J tests,
      b.  In vitro cytogenetic damage: both chromosomal aberration and SCE (in CHO cells,  or human lymphocytes, or other
         rodent/human cell lines/strains tests,
   ** c.  Iji vivo cytogenetics test for chromosomal aberrations using bone marrow preparations of rats,
      d.  Dominant lethal test in rats or mice.
    These data are necessary to maintain registration during the period of Special Review and any hearings; they must be
    submitted as soon as practicable in light of ongoing work and in any case no later than eighteen months from the
    receipt date of this guidance package.
 7/ A dermal absorption study must be submitted.  It is data necessary to maintain registration during the period of
    Special Review and any hearings; it must be submitted in January, 1985.  Monsanto committed to this date in
    its letter dated 9/21/84.
 8/ A 21-day dermal study must be submitted.
 9/ Data required by this registration standard to be held in abeyance pending outcome oE the Special Review.
10/ A one-year feeding study in dogs with a demonstrated NOEL is required.
    It is data necessary to maintain registration during the period of Special Review and any hearings; it must be
    submitted as soon as practicable in light of ongoing work and in any case no later than eighteen months from the
    receipt date of this guidance package.
ll/ N/A3 Not applicable for the purposes of this guidance package.

12/ Two nutagenicity studies (Ace.253308, April 1984) were submitted to the Agency and they were reviewed.
    The Agency found the study involving in vitro/ Ir» vivo primary hepatocyte repair for UDS testing acceptable, but
    the Agency found the second study** involving In vivo cytogenetics test for chromosomal aberrations using bono
    marrow preparations ot rats incomplete and unacceptable.

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                                                        TABLE A
                                        GENERIC DATA REQUIREMENTS FOR ALACHLOR
Data Requirement
           I/   Use  2/
Composition   Pattern	
Does EPA Have Data
To Satisfy This
Requirement?  (Yes,
No or Partially)
Bibliographic
  Citation
Must Additional
Data Be Submitted
Under FIPRA Section
3(c)(2)(B)7
SI58.145 wildlife and
 Aquatic Organisms

  AVIAN AND MAMMALIAN TESTING

  71-1 - Acute Avian Oral Toxicity   TGAI      A,B

  71-2 - Acute Avian Dietary         TGAI      A,B
          Toxicity

  71-3 - Wild Mammal Toxicity        TGAI

  71-4 - Avian Reproduction          TGAI

  71-5 - Simulated and Actual        TCP
          Field Testing -
          Mammals and Birds

  AQUATIC ORGANISM TESTING

  72-1 - Acute Freshwater Fish       TGAI      A,B
          Toxicity
  72-2 - Acute Freshwater            TGAI      A,B
          Invertebrates Toxicity
  72-3 - Acute Estuarine and         TGAI
          Marine Organisms
          Toxicity

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

                            Reserved 3/


                            N/A 4/

                            N/A

                            N/A
                            Yes
                            Yes
                            Reserved 3/
                            N/A
                     00079523
                     00023615,00028554
                     00023616,00031521
                     00028550,00031522
                     00028551,00031524
                     00028553,00031525

                     00028549,00031523
                     00028552,00031526
                     00028555
                     No
                                                                      No
                                                                                                       No

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                                                        TABLE A
                                        GENERIC DATA REQUIREMENTS FOR ALACHLOR
                                                           Does EPA Have Data                      Must Additional
                                                           To Satisfy This                         Data Be Submitted
                                            I/   Use  2/   Requirement?  (Yes,     Bibliographic     Under  FIFRA Section
Data Requirement	Composition   Pattern     No or Partially)	Citation	3(c)(2)(B)7	

§158.145 Wildlife and
    atic Organisms
   continued)

   72-5 - Fish - Life-Cycle          TCAI                     N/A 4/

   72-6 - Aquatic Organism       TGAI, PAI OR                 N/A
           Accumulation          Degradation
                                   Product

   72-7 - Simulated or Actual        TCP                      N/A
          Field Testing -
          Aquatic Organisms

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                                                        TABLE A
                                        GENERIC DATA REQUIREMENTS FOR AIACHLOR
                                                           Does EPA Have Data                      Must Additional
                                                           To Satisfy This                         Data Be Submitted
                                            I/        2/   Requirement?  (Yes,     Bibliographic    Under FIFRA Section
Data Requirement	Composition   Pattern     No or Partially)	Citation	3(c)(2)(B)7	

S158.155 Nontarget Insect

  NONTARGET INSECT TESTING -
  POLLINATORS;

  141-1 - Honey bee acute            TGAI        A,B           Yes                 00028772           No
           contact toxicity                                                        00074486

  141-2 - Honey bee - toxicity       TEP                       N/A 4/
           of residues on
           foliage

  141-3 - Mild bees important in     TEP                       N/A
           alfalfa pollination -
           toxicity of residues
           on foliage

  141-4 - Honey bee subacute       (Reserved)5/
           feeding study

  141-5 - Field testing for          TEP                       N/A
           pollinators

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

S158.155 Nontarget Insect
         (continued)

  NONTARGET INSECT TESTING -
  AQUATIC INSECTS;

  142-1 - Acute toxicity to      (Reserved)**/
           aquatic insects

  142-2 - Aquatic insect         (Reserved)6/
           life-cycle study

  142-3 - Simulated or actual    (Reserved)6/
           field testing for
           aquatic insects

  143-1 - NONTARGET INSECT       (Reserved)6/
          TESTING - PREDATORS
  thru    AND PARASITES

  143-3
                                                           56

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                                                      TABLE A
                                      GENERIC CATA REQUIREMENTS FOR ALACHLOR
  S158.145 Wildlife and Aquatic Organisms
           (continued)

I/ Composition:  TGAI » Technical grade of the active ingredient; PAI • pure active ingredient;
   TEP • Typical end-use product;
2/ The use patterns are coded as follows:  A=Terrestrial, Pood Crop; B=3terrestrial, Non-Food Crop; C=Aquatic, Food Crop
   D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=<5reenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I-Indoor.
3/ Data requirements pending receipt of environmental fate data.  These data may be necessary to support cotton,
   corn and soybeans uses*
4/ N/A=Not applicable for the purposes of this standard.
5/ [Reserved] Requirement reserved pending development of test methodology.
6/ [Reserved] Pending decision as to whether data requirement should be established.

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                                                  JZ B
       PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ALACHLOR (60% FI)
I/
Data Requirement Composition
$158.120 Product Chemistry
Product Identity:
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation of
Ingredients
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
MP
MP
MP

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

No
No
Yes
No
Yes
No
N/A 4/
N/A
No
GS0063-0001 No
GS0063-0002 Yes 2/
GS0063-0003 Yes 2/

Yes y
Yes y
GS006 3-0004, GS0063-0005 No
GS006 3-0029, GS006 3-0030
GS0063-0031 ,GS0063-0032
Yes y
GS0063-0005 No
Yes y


Yes y
Specific Gravity
                                                 58

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                                                     TABLE B

PRODUCT SPECIFIC DATA
Data Requirement
SI 58. 120
63- 8 -
63- 9 -
63-10 -
63-11 -
63-12 -
63-13 -
63-14 -
63-15 -
63-16 -
63-17 -
63-18 -
63-19 -
Product bhemistry
(continued)
Solubility
Vapor Pressure
Dissociation constant
Octanbl/water partition
coefficient
pH
Stability
Oxidizing or Reducing
Action
Flanmability
Explodability
Storage Stability
Viscosity
Miscibility
REQUIREMENTS FOR
Composition
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MANUFACTURING-USE PRODUCTS CONTAINING ALACHLOR
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
No
No
N/A
No
No
N/A
No
No
No
No
No
No
(60% PI)
Must Additional
Data Be Submitted
Under FIFRA Sectii
3(c)(2)(B)? L
yes yy
Yes yy

Yes yy
Yes y

Yes y
Yes y
Yes y
Yes y
Yes y
Yes 2/
Other Requirements;
64- 1 - Submittal of samples
Choice
N/A

-------
       PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ALACHLOR (90% Technical)
Data Requirement Composition
S158.120 Product Chemistry
Product Identity:
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation of
Ingredients
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density r Bulk Density , or
MP
MP
MP

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

No
No
No
No
Yes
No
N/A4/
N/A
NO
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Sectii
Citation 3(c)(2)(B)7
GR0063-0001 No
GS0063-0002 Yes 2/
GS0063-0003 Yes 2/

Yes y
Yes 2/
Yes y
Yes y
GS0063-0005 No
Yes y


Yes 2/
Specific Gravity
                                                 60

-------
                                                       fiLE C

PRODUCT SPECIFIC DATA
Data Requirement
5158.120
63- 8 -
63- 9 -
63-10 -
63-11 -
63-12 -
63-13 -
63-14 -
63-15 -
63-16 -
63-17 -
63-18 -
63-19 -
Product Chemistry
(continued)
Solubility
Vapor Pressure
Dissociation constant
Octanol/Water partition
coefficient
PH
Stability
Oxidizing or Reducing
Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
REQUIREMENTS FORTH
I/
Composition
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
INUFACTURING-USE PRODUCTS CONTAINING ALACHLOR
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
No
No
N/A
No
No
N/A
No
NO
No
No
No
NO
(90% Technical)
Must Additional
Data Be Submitted
Under FIFRA Sect!
3(c)(2)(B)?
Yes 2/3/
Yes^S/

Yes 2,3,
tea 2/

Yes y
Yes y
Yes y
Yes y
Yes y
Yes y
Other Requirements!
64- 1 - Subtnittal of samples
Choice
N/A
                                                        61

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                                                      TABLE B
              PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ALACHLOR


S158.120 Product Chemistry
         (continued)

I/ Composition!  HP « Manufacturing-use product; Choice » Choice of several test substances determined on a case-by-
   case basis.
y Data must be submitted no later than six months from the receipt date of this guidance  package.
3/ Chemistry data are indicated because of the Agency's concern for groundwater contamination.
4/.N/A- Not applicable for the purposes of this standard.

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                	                                     BLE B
                PRODUCT SPECIFIC DMA REQUIREMENTS FOR HANUFACTURING-USE PRODUCTS CONTAINING AIACHLOR
Data Requirement
Conpoeition~
Does EPA Have Data
To Satisfy This
Requirement?  (Yes,
No or Partially)
Bibliographic
  Citation
Must Additional
Data Be Submitted
Under PIPRA Section
 3(c)(2)(B)?
S158.135 Toxicology

  ACUTE-TESTING

  81-1 - Acute Oral Tbxicity  - Rat   HP

  81-2 - Acute Dermal Tbxicity        HP

  81-3 - Acute Inhalation Toxlcity    HP
          Rat

  81-4 - Primary Eye                  HP
          Irritation - Rabbit

  81-5 - Primary Dermal               HP
          Irritation

  81-6  - Dermal Sensitizatlon        MP
Yes
Yes
Yes
Yes
Yes
Partially
GS0063-0021
GS0063-0022
GB0063-0023
G60063-0024
GS0063-0025
GB006 3-0026
No
No
No
No
NO
Yet
                                                           63

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                                                      TABLE B
              PRODUCT SPECIFIC DKTA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ALACHLOR


5158.135 Toxicology
         (continued)


I/ Ooqpositiont  MP • Manufacturing-use product*
2/ Data required by this registration standard to be held in abeyance pending outcome of the Special Review.
3/ A skin sensitization study in guinea pigs (Ace.252772, March 1984) has been submitted to the Agency and it is being
   reviewed.

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IV.  SUBMISSION OP REVISED LABELING INFORMATION

Note;  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.

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

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

                      A.  Label Contents

     40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label.  This
is referred to as format labeling.  Specific label items
listed below are keyed 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
require on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text.  The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
•26 ounces.* In addition to English units, net contents may
be expressed in metric units.  See Appendix IV-1.  [40 CFR
162.10(d)J

     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
                               65

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 size and style similar to other print on that part of the
 label on which it appears and must run parallel  to it.  The
 registration number and the required identifying phrase must
 not appear in such a manner as to suggest or imply recommendation
 or endorsement of the product* by the Agency.  See Appendix IV-1.
 [40 CFR 162.10(e))

     Item 5.  EPA ESTABLISHMENT NUMBER - The EPA  establishment
 number, preceded by the phrase "EPA Est." is the final estab-
 lishment at which the product was produced, and  may appear
 in any suitable location on the label or immediate container.
 It must also appear on the wrapper or outside container of
 the package if the EPA establishment number on the immediate
 container cannot be clearly read through such wrapper or container.
 See Appendix IV-1.  [40 CFR 162.10(f>]

     Item 6.  INGREDIENTS STATEMENT - An ingredients statement
 is required on the front panel and must contain  the name and
 percentage by weight of each active ingredient and the total
 percentage by weight of all inert ingredients.   The preferred
 location is immediately below the product name.  The ingredients
 statement must run parallel with, and be clearly distinguished
 from,  other text on the panel.   It must not be placed in the
 body of other text.  See Appendix IV-1.   [40 CFR 162.10(g)]

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

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

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

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

     Item 7A.   CHILD HAZARD WARNING STATEMENT - The statement
 "Keep  Out of  Reach of Children" must be  located  on the front
panel  above the signal word except where contact with children
during distribution or use is unlikely.   See Appendix IV-1.
 [40  CFR 162.10(h)(l)(ii)]

     Item 7B.   SIGNAL WORD - The signal word (Caution, Warning,
or Danger)  is  required on the front panel  immediately below
the  child hazard  warning statement.   See Appendix IV-1.
 [40 CFR 162.10  (h)(l)(i)]
                               66

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     Item 7C.   SKULL 6 CROSS BONES AND WORD "POISON" - On products
 assigned a toxicity Category I  on the  basis of oral, dermal,
 or inhalation toxicity,  the word "Poison"  shall appear on the
 label in red  on a background of distinctly contrasting color and
 the -skull and crossbones shall  appear  in  immediate proximity to
 the word POISON.   See Appendix  IV-1.  '[40  CFR 162.10(h) (1) (i~) ]

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

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

     Item 8.   SIDE/BACK PANEL PRECAUTIONARY LABELING - The
 precautionary statements as listed below must appear together
 on the label  under  the heading  "PRECAUTIONARY STATEMENTS."
 The preferred location is at the  top of the side or back
 panel preceding the directions  for use, and it is preferred
 that  these  statements be surrounded by a block outline.  Each
 of  the three  hazard warning statements must be headed by the
 appropriate hazard  title.   See  Appendix IV-1.  [40 CFR 162.10
 
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     2.  Criteria  for declaration of non-flammability.  The
     following  criteria will be used to determine if a product
     is  non-flammable:

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

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

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

            i.  The flame extension is zero inches;

            ii.   There is no flashback; and

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

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

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

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

     In the Registration Standard, the Agency has (1) indicated
certain formulations/uses to be restricted, based either on a
previous classification determination made through the optional
procedures of 40  CPR 162.30 or based on data already available
to the Agency, or (2) reserved any classification decision until
appropriate data  are submitted.
                               68

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

     If you wish to propose that your product should not be
classified for restricted use,  you must submit  any information
and rationale with your application for reregistration.
During the Agency's review of your application, your proposed
classification determination will be evaluated  in accordance with
the provisions of 40 CFR 162.11(c).  You will be notified  of
the Agency's classification decision.'

    A.  Classification Labeling Requirements

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

            a.  The statement "RESTRICTED USE PESTICIDE,
        must appear at the top of the front panel of the
        label, set in type of the same minimum  sizes as
        required for human hazard signal words  (see table  in
        40 CFR 162.10(h)(l)(iv).

            b.  Directly below this statement on the front
        panel, a summary statement of the terms of restric-
        tion shall appear.  If use is restricted to certified
        applicators, the following statement is required:
        "For retail sale to and use only by Certified  Applicators
        or persons under their direct supervision and  only
        for those uses covered by the Certified Applicator's
        Certification."

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

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

            b. You may delete all restricted uses from your
        label and submit draft labeling bearing only unres-
        tricted uses.
                              69

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

         B.  Compliance Schedules

         No product with a use classified for restricted use
     under this Standard may be released for  shipment by the
     registrant or producer after one year  from the  date of
     issuance of this Standard, unless such product  bears the
     restricted use classification.  All products still in
     channels of trade after two  years from the date of issuance
     of this Standard must be labeled for restricted use.

     Item 10A.  STORAGE AND DISPOSAL BLOCK  -  All labels are
 required to bear storage and disposal statements.   These
 statements are developed for specific containers, sizes, and
 chemical content.   These instructions must be  grouped and
 appear under the heading "Storage and Disposal" in  the directions
 for  use.  This heading must be set in the  same type sizes as
 required for the child hazard warning.  Refer  to Appendix
 IV-4 to determine the disposal instructions  appropriate for
 your products.

     Item 10B.  DIRECTIONS FOR USE -  Directions for  use must
 be stated in terms which can be  easily  read  and understood by
 the  average person likely to use or  to  supervise the use of
 the  pesticide.  When followed, directions  must be adequate to
 protect the public from fraud and from  personal injury and to
 prevent unreasonable adverse effects on the  environment.  See
 Appendix IV-1.  [40 CFR 162.10]


                    B.   Collateral Labeling

     Bulletins, leaflets,  circulars,  brochures, data sheets,
 flyers,  or other graphic printed matter which  is referred to
 on the label or which is to accompany the  product are termed
 collateral labeling.   Such labeling  may not  bear claims or
 representations that differ in substance from  those accepted
 in connection with registration  of the  product.  It should be
made  part of the response to this notice and submitted for
 review.
                               70

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 V.    INSTRUCTIONS FOR SUBMISSION

     All applications prepared in response to this Notice should
 be addressed as follows:
     Rooert J. Taylor
     Product Manager 25
     Registration Division (TS-767)
     Office of Pesticide Programs
     Environmental Protection Agency
     Washington. D.C.  20460
     Phone No. (703) 557-1800

 For each product for which continued registration is  desired

     1.   Within 90 days from receipt of this document, you must
         submit the "FIFRA Section 3(c)(2)(B) Summary  Sheet"  EPA
         Form d580-l.  Refer to Appendix II-2 with appropriate
         attachments.

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

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

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

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

         d.   Two copies of draft labeling  including the label  and
             associated brochures.   If current labeling  conforms
             to the requirements of  this guidance document and  the
             results  of the short-term data,  the registrant may
            _s_ubmi_t suchm labeling.   j( End-use product labeling
             needs to comply specifically with the instruction  in
             Section II of this guidance document.) The  labeling
             should be either typewritten text on 8-1/2  x 11  inch
             paper or a mockup  of the  labeling suitable  for
             stortage in 8-1/2  x 11  inch files.  The draft label
             must indicate the  intended,.colors of The' final labej.,
             clear indication of the front panel  label,  and the
             intended type sices of  the text.

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

Note;  If for  any reason any required test is delayed or aborted
       so that meeting  the  agreed submission time  will  be delayed.
       notify  the Product Manager listed  above.

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

                                .71

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                                          Appendix II-l

              Guide to Use of This Bibliography


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

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

3.  IDENTIFICATION 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 NRID entries.  This temporary identifier number is
    also to be used whenever specific reference is needed.

4.  FORM OF ENTRY.  In addition to the Master Record Identifier
    (MRID), each entry consists of a citation containing
    standard elements followed, in the case of material
    submitted to EPA, by a description of the earliest known
    submission.  Bibliographic conventions used reflect the
    standards of the American National Standards Institute
    (ANSI), expanded to provide for certain special needs.
                               72

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                                   Appendix II-l (continued)

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

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

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

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

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

    (2)  Administrative Number.  The next element,
         immediately following the word "under," is the
         registration numb ~, 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.
                            73

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                                              Appendix II-2
 MRID Nunber
Alachlor Bibliography
 00023012   Sutherland, M.L.; Curtis, T.G.; Darlington,  W.A.; -et al.  (1972)-
              Final Report on Lasso and the Environment: Part 4: Photolysis of
              Lasso on soil and in Water: Agricultural Research Report No 262
              (Unpublished study received June 29,  1973  under 3F1372; submitted
              by Monsanto Co., Washington, D.C.;  CDL:093660-L)

 00023014   Sutherland, M.L.; Curtis, T.G.; Darlington,  W.A.; et al.  (1972)
              Final Report on Lasso and the Environment: Part 6: Soil Dissipa-
              tion of Lasso:  Agricultural Research Report No 264 (Unpublished
              study received June 29, 1973 under  3F1372; submitted by Monsanto
              Co., Washington, D.C.; CDL:093660-N)

 00023015   Sutherland, M.L.; Curtis, T.G.; Darlington,  W.A.; et al.  (1972)
              Final Report on Lasso and the Environment: Part 7: Soil Binding
              and Phytotoxicity of Lasso Residues:  Agricultural Research  Report
              No. 265 (Unpublished study received June 29, 1973 under 3F1372;
              submitted by Monsanto Co., Washington, D.C.; CDL:09366U-O)

 00023615   Thompson, C.M.; Forbis, A.D.; McAllister, W.A. (1978) Acute
              Toxicity of Technical Alachlor (AB-78-166) to Bluegill Sunfish
              (Lepcmis macrochirus).  (Unpublished  study received Aug. 16,
              1978 under 524-285;  prepared by analytical Biochemistry Labora-
              tories, Inc., submitted by Monsanto Co., Washington, D.C.;
              CDL: 234628-C)

00023616   Forbis, A.D.j McAllister, W.A. (1978) Acute  Toxicity of Technical
              Alachlor to Rainbow Trout (Salmo qairdineri). (Unpublished
              study received Aug.  16, 1978 under  524-285; prepared by Analytical
              Biochemistry Laboratories, inc., submitted by Monsanto Co.,
              Washington, D.C.; CDL: 234628-D)

00027139   Weidner, C.W. (1974) Degradation in Groundwater and Mobility  of
              Herbicides.  Master's thesis, Univ. of Nebraska,  Dept. of Agronomy
              (Unpublished study received Jul 19, 1978 under 201-403; submitted
              by Shell Chemical Co., Washington,  D.C.; CDL:234472-0)

00027140   Lavy,  T.L. (1974) Mobility and Deactivation  of Herbicides in  Soil-
              Water Systems: Project A-024-NEB.  (Available from: National
              Technical Information Service, Springfield, VA:PB-238 632;  un-
              published study received Jul 19, 1978 under 201-403; prepared by
              Univ. of Nebraska.  Water Resources Research Institute, sub-
              mitted by Shell Chemical Co.., Washington, D.C. CDL:234472-P)

00028549   McAllister,  W.A.j Forbis, A.D. (1978) Acute  Toxicity of Technical
              Alachlor (AB-7B-200) to Daphnia magna.  (Unpublished study
              received Dec. 28, 1979 under 524-285;  prepared by Analytical Bio
              Chemistry Laboratories, Inc., submitted by Monsanto Co., Wash-
              ington,  D.C.; CDL:241535-A)
                                         74

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 00028550   Thompson, C.N.; Forbis A.D. -(1978) Acute Toxicity of Lasso (MCB/
              Gg) (AB-78-111) to Rainbow Trout (Salmo gairdneri).  (Unpub-
              lished study received Dec. 28, 1977 under 524-285; prepared by
              Analytical Bio Chemistry Laboratories, Inc., submitted by Monsanto
              Co., Washington, D.C.; CDL:241535-P)

 00028551   Thompson, C.M.: Forbis A.D. (1978) Acute Toxicity of Lasso (NCR/
              CgM AB-78-111) to Bluegill Sun fish (Leponis macrochirus).
              (Unpublished study received Dec. 28, 1979 under 524-285; prepared
              by Analytical Bio Chemistry Laboratories, Inc., submitted by
              Monsanto Co., Washington, D.C.; CDL-.241535-C)

 00028552   McAllister, W.A.; For is, A.D. (1978)  Acute Toxicity of Lasso
              (MCB/Cg) (AB-78-111) to Daphnia magna.  (Unpublished study received
              Dec 28, 1979 under 524-285; prepared by Analytical Bio Chemistry
              Laboratories, Inc., submitted by Monsanto Co.,  Washington, D.C.
              CDL:241535-D)

 00028553   Thompson, C.M.; Forbis, A.D. (1978) Acute Toxicity of Lasso EC
              (MCB)  (AB-78-167B)  to Rainbow Trout (Salmo gairdneri).
              (unpublished study received Dec. 28, 1979 under 524-285;
              preparedd by Analytical Bio Chemistry Laboratories, Inc.,
              submitted by Monsanto Co., Washington, D.C.; CDL241535-E)

 00028554   Thompson, C.  M.;  Forbis, A.D. (1978)  Acute Toxicity of Lasso EC
              (MCB)  (AB-78-167)  to Bluegill Sunfish ( Leponis macrochirus).
              (Unpublished study  received Dec. 28,  1979 under 524-285; pre-
              pared  by Analytical Bio Chemistry Laboratories, Inc., submitted
              by Monsanto Co., Washington,  D.C.;  CDL:241535-F)

 00028555   McAllister, W.A.; Forbis, A.D.  (1978) Acute Toxicity of Lasso EC
              (MCB)  (AB-78-167) to Daphnia magna.  (Unpublished study received
              Dec. 28,  1979 under 524-285;  prepared by Analytical Bio Chemistry
              Laboratories, Inc.,  submitted by Monsanto Co.,  Washington, D.C.;
              CDL:241535-G)

 00028556   Lauer, R.; Arrans, D.D.; Stranz, J.L,;  et al.  (1979)  Residues of
              Alachlor and Atrazine in Field Treated Sorghum  following Pre-
              or Postemergent Applications with Lasso-(R)  i or a  Lasso-(R)  * +
              Atrazine Tank Mix:   Report No. MSL-1033.   Rev.  (Unpublished
              study  received Mar 25, 1980 under 524-285; prepared in coopera-
              tion with ABC Laboratories,  Inc., submitted  by  Monsanto Go.,
              Washington,  D.C.; CDL-.099326-A)

 00028557   Monsanto Company (19??)  Analytical Residue  Method for Alachlor
              in Sorghum Forage, Fodder  and Grain.  Two  undated methods.
              (Unpublished study received Mar 25, 1980  under  524-285;  CDL:
              099326-B)

00028558   Monsanto Company (19??)  Reasonable Grounds  in  Support of  the Re-
             guest: Lasso,  (unpublished study received Mar  25,  1980 under
             524-285; CDL: 099326-C)
                                         75

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00028563   Danhaus, R.G.; Stranz, J.L.; TDubelman, S. (1980) Residues of
             Alachlor and Atrazine in Field Treated Corn following Preemer-
             gent and Lay-by applications of Lasso-(R) or Lasso-(R) +
             Atrazine Tank Mixes; Report No. MSL-1105. (Unpublished study
             received Apr 24, 1980 under 524-285; prepared in cooperation
             with ABC Laboratories, Inc., submitted by Monsanto Co.,
             Washington, D.C.; CDL:099396-A)

00028564   Ahmed, P.E.; Underwood, P.C.: Tegeris, A.S. (1980) Alachlor: Six
             Month Study in the Dog: Opthalmological Findings to Date.
             (Unpublished study received April 29, 1980 under 524-314;
             prepared by Pharmacopathics Research Laboratories, Inc.,
             submitted by Monsanto Co., Washington, D.C.; CDL;242371-B)

00028772   Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1973) Toxicity
             of Pesticides and Other Agricultural Chemicals to Honey Bees:
             Laboratory Studies.  Rev. By Univ. of California—Riverside,
             Dept. of Entomology.  Riverside, Cali.: UC, Agricultural Extension
             Service.  (Also-In_unpublished submission received April 2, 1980
             under 464-556; submitted by Dow Chemical U.S.A.; Midland, Mich.;
             CDL:242149-Z)

00031521   Thompson, C.M.; Forbis, A.D.; Oleson, F.B.; et al. (1979) Acute
             Toxicity of Lasso-(R) NF-79-WB (AB-79-173) to Rainbow Trout
             (Saline gairdneri); Static Acute Bioassay Report #24529. (Unpub-
             lished study received Jan 17, 1980 under 524-EX-491.  Prepared
             in cooperation with Analytical Bio Chemistry Labs., Inc., sub-
             mitted by Monsanto Co., Washington, D.C.; CDL:241619-B)

00031522   Thompson, C.M.; Forbis, A.D.; Oleson, F.B; et al. (1979) Acute
             Toxicity of Lasso - (R) NF-79-WB (AB-79-174) to Bluegill Sunfish
             (Lepomis macrochirus): Static Acute Bioassay Report *24530.
             (Unpublished study received Jan. 17, 1980 under 524-EX-49; pre-
             pared in cooperation with analytical Bio-Chemistry Laboratories,
             Inc., submitted by Monsanto Co., Washington, D.C.; CDL: 241619-C)

00031523   Thompson, C.M.; Forbis, A.D.; Oleson, F.B. (1979) Acute Toxicity
             of Lasso NF-79-WB (AB-79-175) to Daphnia magna; Static Acute
             Bioassay Report 24531. (Unpublished study received Jan 17, 1980
             under 524-EX-49; prepared in cooperation with Analytical Bio
             Chemistry Laboratories, Inc., submitted by Monsanto Co., Wash-
             ington, D.C.; CDL:241619-D).

00031524   Thompson, C.M.; Forbis, A.D.; Oleson, F.B.; et al. (1979) Acute
             Toxicity of Lasso-(R)NF-79-WB (AB-79-068) to Rainbow Trout
             (Salmo gairdneri); Static Acute Bioassay Report 124007. (Unpub-
             lished study received Jan 17, 1980 under 524-EX-491.  Prepared
             in cooperation with Analytical Bio Chemistry Labs., Inc., sub-
             mitted by Monsanto Co., Washington, D.C.; CDL:241619-E)
                                         76

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00031525   Thompson, C.M.? McAllister, W.A.; Oleson, P.B;  et al. (1979)
             Acute Toxicity of Lasso - (R)t NF-79-WB (AB-79-069) to Blue-
             gill Sunfish (Lepomis macrochirus)* Static Acute Bioassay
             Report 124008, (Unpublished study received Jan. 17, 1980 under
             524-EX-49; prepared in cooperation with analytical Bio-Chemistry
             Laboratories, Inc., submitted by Monsanto Co., Washington,  D.C.;
             COL: 241619-F)

00031526   Thompson, C.M.; Forbis, A.D. Oleson, F.B. (1979) Acute Toxicity
             of Lasso - (R)t NF-79-WB (AB-79-070) to Daphnia magna; Static
             Acute Bioassay Report 124009.  (Unpublished study received
             Jan 17, 1980 under 524-EX-49; prepared in cooperation with
             Analytical Bio Chemistry Laboratories, Inc.,  submitted by
             Monsanto Co., Washington, D.C.; CDL:241619-G)

00043645   Rodwell, D.E.: Tasker, B.J. (1980) Teratology Study in Rats:  IRDC
             No. 401-058; IR-79-020.  (Unpublished study including submitter
             summary, received Oct. 16, 1980 under 524-385; prepared by
             International Research and Development Corp., submitted by
             Monsanto Co., Washington, D.C.; CDL:243506-A)

           Rubin, L.F. (1980) Ocular Lesions: Project No.  77-1065. (Unpub-
             lished study received Dec. 1, 1980 under 524-385; submitted by
             Monsanto Co., Washington, D.C.; CDL:243857-A)

           Pharmacopathics Research Laboratories, Incorporated  (1980)
             OphthaLnological Examination of Dogs. (Compilation: unpublished
             study received Dec. 10, 1980 under 524-385; submitted by
             Monsanto Co., Washington, D.C.; CDL:243857-B)

00068044   Wilson, G.R. et al. (1981) Residues of Alachlor in Sorghum Forage,
             Stover, and Grain. Report No. MSL-1577.  ( Unpublished study received
             May 27, 1981 under 524-285; prepared by ABC Laboratories, Inc.,
             submitted by Monsanto Co., Washington, D.C.; CDL:245225-A)

00068045   Monsanto Company (19??) Reasonable Grounds in Support of the Request:
             Lasso. (Unpublished study received May 27, 1981 under 524-285;
             CDL:245225-B)

00074486   Atkins, E.L.: Kellun, D. (1980) Effect of Pesticides on Apiculture:
             Maximizing the Effectiveness of Honey Bees as Pollinators:
             Project No. 1499.  1980 annual rept. (Unpublished study received
             June 8, 1981 under 2141-159; prepared by Univ. of California-
             Riverside, Citrus Research Center and Agricultural Experiment
             Station, Dept of Entomology, submitted by American Cyanamid Co.,
             Princeton, N.J.: CDL:070148-G
00064546
00064547
                                        77

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 00075062   Schroeder, R.E.: Hogan,G.K.; Shock, M.E.; et al. (1981) A Three
              Generation Reproduction Study in Rats with Alachlor: Project No.
              77-2066. Final rept.  (Unpublished study received Jul 10, 1981
              under  524-285; prepared by Bio/dynamics, Inc., submitted by
              Monsanto Co., Washington, D.C.; CDL:070177-A)

 00075709   Daly, I.W.;  Hogan, G.K.; Plutnick, R.; et al. (1981) An Eighteen
              Month  Chronic Feeding Study of Alachlor in Mice: Project No.
              77-1064.   Final rept. (Unpublished study received Jul 1, 1981
              under  524-285; prepared by Bio/dynamics, Inc., submitted by
              Monsanto Co., Washington, D.C.; CDL:U70168-A; 070169)

 00078301   Guth, J.A. (1975) CGA-24705 Leaching Model Study with the Herbicide
              CGA-24705  in Four Standard Soils: Nr. SPR 3/75.  (Unpublished
              study  received Jul 23, 1981 under 100-587; prepared by Ciba-
              Geigy, Ltd., Switzerland, submitted by Ciba-Geigy Corp.,
              Greensboro, NC.; CDL: 245628-E.

 00079523   Fink, R.; et al. (1979) Final Report: Acute Oral LDsQ-Bobwhite Quail:
              Project No. 139-179.  (Unpublished study received June 2, 1981
              under  524-285; prepared by Wildlife International, Ltd., submitted
              by Monsanto Co., Washington, D.C.; CDL:245260-A)

 00087479   Ahmed, F.E.; Tegeris, A. S.; Underwood, P.C.; et al. (1981) Ala-
              chlor:   Six Month Study in the Dog: Testing Facility's Report
              No. 7952;  sponsors Report No. PR-80-015.  (Unpublished study
              including submitter surrmary, received Dec. 1, 1981 under 524-316;
              prepared by Pharmacopathics Research Laboratories, Inc., submit-
              ted by Monsanto Co., Washington, D.C.; CDL:246229-A; 246293)

 00087855   Malik, J.M.  (1981)  Bioconcentration of Alachlor in Channel Catfish
              under Static Conditions:  Report No. MSL-1910. Final Report
              (Unpublished study received Dec. 23, 1981 under 524-285; submitted
              by Monsanto Company, Washington, DC.; CDL:246506-A)

 00091043   Street, R.W.  (1982)  Assessment of Oncogenc Risk for Lasso*
              Herbicide:  Special Report MSL-1983.  (Unpublished study received
              Jan 5,  1982 under 524-2R5; submitted by Monsanto Co., Washington,
              D.C.,:  CDL:0870585-C)

 00091044   Lauer, R.; Arras, D.D.; Adams,  S.A.  (1981) Aerial and Ground
              Applicator Exposure Studies with Lasso® herbicide under Actual
              Field Conditions.  Report  No.  MSL-1889.  Final Report. (Unpublished
              study received Jan.  5, 1981 under 524-285;  submitted by Monsanto
              Company, Washington, DC.;  CDL:07U591-A)

00091U46  Maibach,  H.I. (1981)  Elimination of  14C Alachlor in Rhesus Monkeys
              following a Single Parenteral Dose:  Study MA-81-261.  (Unpublished
              study received Jan b,  1982 under 524-285; prepared by Univ.  of
              California; San Francisco,  School of  Medicine,  submitted by
              Monsanto Company, Washington, DC.; CDL:()80592-B)

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00091047   Franz, T.T.  (1981) Evaluation of the Percutaneous Absorption of
             Alachlor Technical and Lasso* Formulations in Man Using an In Vitro
             Technique: Study No. UW-81-262. Final rept.  (unpublished study
             received Jan 5, 1982 under 524-285; prepared by Univ. of Washington,
             Dermatopharmaoology Laboratory, submitted by Monsanto Co.;
             Washington, D.C.j CDL:070592-C)

00091050   Daly, I.W.; McCandless, J.B.; Jonassen, H.; et al. (1981) A Chronic
             Feeding Study of Alachlor in Rats; Project No. 77-2065.  Final
             rept. (Unpublished study received Jan 5, 1982 under 524-285;
             prepared by Bio/dynamics, Inc., submitted by Monsanto Co.,
             Washington, D.C.; CDL:070586-A: 070587; 070588; 070589; 070590)

00100795   Monsanto Company (1982) Environmental Fate of Microencapsulated Alachlor
             Vbl. I.  (Unpublished study received May 26, 1982 under 524-344;
             prepared by Monsanto Agricultural Products Company; submitted by
             Monsanto Co.; Washington, D.C.; CDL:070839, 070840, 070842)

00101531   Monsanto Company (1982) Environmental Fate of Microencapsulated Alachlor
             Vol. II.  (Unpublished study received May 26, 1982 under 524-344;
             prepared by Monsanto Agricultural Products Company; submitted by
             Monsanto Co.; Washington, D.C.; CDL:070841)
                                        79

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GS0063-0001  Pesticides Process Encyclopedia 1977. Marshall Sit tig, Noyes Data
             Corp., Park Ridge* N.J., p.5

GS0063-0002  Monsanto Company  (1973) Section A of PP*3F1406: Lasso (unpublished
              study received 1973 under 524-???} CDL: 118284)

GS0063-0003  Monsanto Company  (1975) Appendix Ar Confidential Statement of Formula
              for EPA Reg. No. 524-315 and 524-316: Lasso (received 1975)

GS0063-0004  Monsanto Company  (1974) Correspondence to PW3F1406 (received 1974,
              CDL: 118776)

GS0063-0005  Monsanto Company  (1979) Section A of PPt9F2144 (received 1979,
              CDL: 225417)

GS0063-0006  Monsanto Company  (1967) Metabolism Section-soybeans and corn. Section
              D-II of PPt7F0622. Lasso.(Unpublished study received 1967 under
              524-???; CDL:115143)

GS0063-0007  Monsanto Company  (1969) Metabolism Section-peanuts and cotton. Section
              D-II of PP49F0776. Lasso.(Unpublished study received 1969 under
              524-???; CDL:115827)

GS0063-0008  Monsanto Ccnpany  (1984) Metabolism of Synthetic 14C- Labeled Plant
              Metabolites of Alachlor in Laying Hens, Part I: Distribution of 14C-
              Metabolites in Eggs, Tissues, and Excretia. RD. No. 532 (unpublished
              study received 1984 under 524-314; CDL: 252792)

GS0063-0009  Monsanto Company  (1984) Metabolism of Synthetic 14C- Labeled Plant
              Metabolites of Alachlor in Lac tat ing Goats, Part I: Distribution of 14C-
              Metabolites in Milk, Tissues, and Excretia. RD. No. 531 (unpublished
              study received 1984 under 524-314; CDL:252793)

GS0063-0010  Monsanto Company  (1969) Section D, Part III of PP*9F0740-Supplement
              (Received 1969.  CDL: 115685)

GS0063-0011  Monsanto Company  (1971) Section D, Part B of PP*lFl009-Supplenent
              (Received 1971.  CDL: 116791)

GS0063-0012  Monsanto Company  (1972) Chemical Residue Studies. Section D-l of
              PP*2G1176 (Received 1972. CDL:117410)

GS0063-0013  Monsanto Company  (1973) Chemical Residue Studies. Section D-l of
              PPt2G1176 (Received 1973. CDL:118284)

GS0063-0014  Monsanto Company  (1973) Section D PM3F1406 (Received 1973.
              CDL:118776)
                                         80

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GS0063-0015  Monsanto Company (1967) Section D of PPI9F0740 (Received 1967.
              CDL:115690)

GS0063-0016  Monsanto Company (1973) Section D of PPI3F1334 (Received 1973.
              CDL:118044)

GS0063-0017  Monsanto Company (1973) Section D of PPI3F1372 (received 1973,
              CDL:118178)

GS0063-0018  Monsanto Company (1981) Section D of PPI1F2447 (received 1981,
              CDL:243785)

GS0063-0019  Monsanto Ocnpany (1977) Section D of PP#7G2002 (received 1977,
              CDL:101562)

GS0063-0020  Monsanto Company (1975) Appendix A, Confidential Statement of
              Formula for EPA Reg. No. 524-315: Lasso (unpublished study
              received 1975 under 524-???; CDL: 118284)

GS0063-0021  Monsanto Ccnpany (1978) Acute Oral 11)50 - Rat. Submitted by
              Bio/Dynamics, Inc., PD-77-433 on June 28, 1978 (unpublished study
              received 1978; CDL:241273)

GS0063-0022  Monsanto Ccnpany (1979) Acute Dermal LDso - Rabbit. Submitted by
              Bio/Dynamics, Inc., PD-77-433 on April 30, 1979 (unpublished study
              received 1979; CDL:241273)

GS0063-0023  Monsanto Company (1981) Acute Inhalation 0)50 - Rat. Submitted by
              Bio/Dynamics, Inc., PD-81-183 on Dec. 3, 1981 (unpublished study
              received 1981; CDL:248053)

GS0063-0024  Monsanto Company (1981) Primary Eye Irritation - Rabbit. Submitted by
              Bio/Dynamics, Inc., PD-77-433 on May. 25, 1978 (unpublished study
              received 1978; CDL:241273)

GS0063-0025  Monsanto Company (1978) Primary Dermal Irritation - Rabbit. Submitted
              by Bio/Dynamics, Inc., PD-77-433 on March 22, 1978 (unpublished study
              received 1978; CDL:241273)

GS0063-0026  Monsanto Company (1984) Dermal Sensitization - Guinea Pig. Submitted
              on March 24, 1984 (Unpublished study received 1984; CDL:252772)

GS0063-0027  Stout, L.D. et al. (1983) A Chronic Study of Alachlor Administered
              in Feed to Long-Evans Rats. EHL 1800218, Project IML-80-186, Report
              MSL-3282/3284. Vol. I of III (Unpublished study received Feb. 28,1984
              under 524-316; prepared by Monsanto Environmental Health Laboratory
              (EHL); submitted by Monsanto Co., Washington, D.C.; CDL:252496)

-------
 GS0063-0028  Stout, L.D. et al. (1983) A Chronic Study of Alachlor Administered
               in Feed to Long-Evans Rats. EHL #800218, Project tML-80-186, Report
               MSL-3282/3284. Vol. II of III (Unpublished study received Feb.  28,1984
               under 524-316; prepared by Monsanto Environmental Health Laboratory
               (EHL); submitted by Monsanto Co., Washington,  D.C.;  CDL:252497)

 GS0063-0029  Stout, L.D. et al. (1983) A Chronic Study of Alachlor Administered
               in Feed to Long-Evans Rats. EHL 1800218, Project tML-80-186, Report
               MSL-3282/3284. Vol. Ill of III (Unpublished study received Feb. 28,
               1984  under 524-316; prepared by Monsanto Environmental  Health  Labo-
               ratory (EHL); submitted by Monsanto Co., Washington, D.C.; CDL:252498)

 GS0063-0030  Monsanto Company (1983) Rat Metabolism Study. MSL-3198,R.D. 493
               Part I and II (Unpublished study received Oct. 1983  under 524-316;
               prepared by Monsanto Agricultural Products Company;  submitted by
               Monsanto Co., Washington, D.C.;  CDL:251543 and 251544)
GS0063-0031
GS0063-0032
GS0063-0033


GS006 3-0034
GS0063-0035
GS0063-0036
GS0063-0037
Environmental Protection Agency  (1976) EPA Manual of Chemical Methods
  for Pesticides and Devices. Vol. I  ( Prepared by Chemical and Bio-
  logical  Investigations, Chemistry Laboratory; Beltsville, MD;
  received unknown date under 524-316; CDL: none)

Environmental Protection Agency  (1976) EPA Manual of Chemical Methods
  for Pesticides and Devices. Vol. II ( Prepared by Chemical and Bio-
  logical  Investigations, Chemistry Laboratory; Beltsville, MD;
  received unknown date under 524-316; CDL: none)

Monsanto  Company (1982) Alachlor Residues in Peanut Fractions.
 Amendment to PPIOF2313 (Received 1982, CDL:070864)

Monsanto  Company (1982) 21-Day Dermal Ibxicity in Rabbit. IRDC 1401-
  164 (IR-81-036) (Unpublished study received May 13, 1982 under 524-
  316. Prepared by International  Research and Development Corp.; sub-
 mitted by Monsanto Co., Washington, D.C.; CDL:247960)

Shirasu et al.  (1980) Microbial  Mutagenicity Study (Received Feb.
 1980 under 524-316.  Prepared by Institute of Environmental
 Toxicology; Kodaira, Japan; submitted by Monsanto Co., Washington,
 D.C.; CDL:248053)

Monsanto  Company (1979) Environmental Chemistry of Alachlor
  (Unpublished study received Oct. 17, 1979 under 524-285, -296, -314
 prepared by Monsanto Agricultural Products Company; submitted
 by Monsanto Co., Washington, D.C.; CDL:241135 and 241136)

Monsanto  Company (1983) Additional Corn and Soybean Metabolism Studies
 to Support the Registration of  Lasso*, EC, II, and ME. R.D. No. 489,
 Special  Report MSL-3132.  (Unpublished study received Sept. 16, 1983
 under 524-285, -296,- 314, and -344; prepared by Monsanto Agricultural
 Products Company; submitted by Monsanto Co., Washington, D.C.;
 CDL:251375)
                                          82

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 GS0063-0038
 GS0063-0039



 GS0063-0040


 GS0063-0041
GS0063-0042
GS0063-0043
Zahner, A.J.  (1984) Summary of Data Supporting Bronco* R.D. 503
  (Unpublished study received Feb. 23, 1984 under 524-285, -296,
  -314, and -344; prepared by Monsanto Agricultural Products Company:
  submitted by Monsanto Co., Washington, D.C.; CDL:252489)

Datta, P.R. (1984) Memorandum sent to David J. Severn dated March
  26, 1984.  Review of Six Documents Regarding Monitoring of Pesti-
  cides in Northwestern Ohio Rivers.

Offutt, C.K.  (1984) Memorandum sent to Diane lerley dated May 10,
  1984.  Monitoring Data for Alachlor in Chio and Iowa.

Monsanto Company (1984) A Teratology Study in Rabbits: IR-83-045
  (Unpublished study including submitter summary, received Mar.
  1, 1984 under 524-285, -296, -314, and -316; prepared by
 Monsanto Agricultural Products Company; submitted by Monsanto
 Co., Washington, D.C.; CDL:252570)

Scott, L.D. et al. (1984) A Special Chronic Feeding Study with
 Alachlor in Lonq-Evans Rats. 3HL 1800219, Proiect 4ML-RO-224,
 Report MSL-3292. (Unpublished study received April 23, 1984
 under 524-316; prepared by Monsanto Environmental Health Labo-
 ratory (EHL); submitted by Monsanto Co., Washington, D.C.;
 CDL:253306, 253307)

Mirsalis, J.C. et al. (1984) An Evaluation of the Potential of
 Alachlor to Induce Unscheduled DN& Synthesis in the In vitro-In
 Vivo Hepatocyte-DNA Repair Assay.  Project No. SRI LSC 83-201,
 6642, Study No. SR-83-293.  (Unpublished study received April
 1984, under 524-316:  prepared by SRI International, Menlo Park,
 CA ;  submitted by Monsanto Co., Washington, D.C.; GDL:253308)

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OMB
                                                                                      . 2GGO-GS.63 .'
                 FIFHA SECTION 3(C)(2J(B) SUMMARY SHEET
                                                                               EPA Af QiSTMAi ION NQ.
  PftOOUCTNAME
  APPLICANT'S NAME
       OATl GUIDANCE DOCUMENT ISSUES
   Whn nagact a till nqunraant to aiboit "gviiHe* dra import by at FIFRA acdoa 3(0(2(8) nctia caaaiatd in tiu rtfruind
   Cutdana Ooeunvit. I aa rvpendmg IB ttf follwioj ai
      Q L I win Mitmh tea in • *ntJy muuur a Mtirfy tti feflowinj nqnnmin& M tti mt praadura I win in dtvitu frem (em net
                    tfti Rtginntian Gutdilina or^u Preracsta camiMd in flu Ripara af EzptR Srevpi a tw Chonicalf Graup, OEC9
           Otamieali Tcoing Prsanfflflt, I andea ttt arsaesU Ait I wffl i
          I havt annnd ion in tqrmmmn win em ar men atiur rostrum lindir FIFRA ausan 3(C](2](B)(Ii} a aniify tha foOewing di
          fawinman& Th« wa, and tny nquind pmsesii, win bi ubmhad a E?A by:
   NAMC Of OTHCA AEfilSTRANT
     Ol. I andov i esmplmd *C«rtiflatiea ef Aanpt a Eitar Ints in *gntm«nt win OnirRtgannafar OwtJapmint ef Oia" with
            B«et a mi fallowing dra nqulnmaos
     G 4. I fi^uan 0i«t you imind my rtsaurrJoa by tftlning tfit faltewiflg aau (tf>a apden • net mibbli a i^pCcanu far ntw preducsi:
    O L  I novan wiunary onoflitien af thi rcpnrrtiofl af nit praduai (Tbi> apden a net tviaabii a csficann for IMW praducaJ
AEClSTTtAATTS AtrTMCHJZSC
                        OATI

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                                                             QMS
                                                                                                             1S-31-SS
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FTo oaWTrY. eawrfVALL *ur rramri 'OR DEVELOPMENT OF DATA
* * Mn duly autfwnxad to noraum SM following finndl who in uejac: to wa recuira*
am ef a Nctica linear FIFRA Section 3(&)O3(B) eonainto in • Guidana Doeunant

1NAMI 0* PIMM




auiOAMC^ aeeuMiMT SAT*
ACTIVC IMeASOllMT
MA C3MPAMY NMACR



1
(This firm or qrouo of fimu ii irfitrid to btlew M "mv firm".) •
    My firm a willing to dtvtlep and jutomh lh« dra « nquirtd by that Netia. if menury. Hewtvtr, my firm would prefer to enter
   tme an aytamant with en* or mera ether itfcauarm to dtvtiop jointly, or to rfiara in th« can of dtvcloptng. tha following nquirtd
   tern* or dan:
3. My firm hu offind la wriring ts mar inta weh u atmmint Ccpto ef *• offin in itachtd. That offer w« imveaali ind Indadii an effar a ba
   ftaund fry an trtrtntjon daiaian undtr FIFXA Smea SldffltBJRii) if final a^iaraam an all arm eauld aet ba mdiad atfiirwia. Tha effir WB nuii
   a flu faOawing fimtal an Di faflewing tfinb):
                                   NAMC Of PIMM
                                                                            -OAT* of
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                     firni
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                                                     Appendix III-l
EPA Registration No._
 PRODUCT SPECIFIC DATA REPORT



	Guidance Docunent for_



                           Date
Registration
Guideline No.
5158.20
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
,- - 	 _-_g{ fr| M.
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density* or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/Water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)


















I am complying with
data requirements by
Citing MRIDt


















Submit-
ting
Data
(At-
tached)


















(For EPA Use Only)
Accession Numbers
Assigned


















                                     86

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               Appendix III-l  (continued)
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
S 158. 135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flarmability
Explodability
Storage stability
Viscosity
Miscibillty
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 an complying with
data requirements by
Citing HRIDt
















Submit-
ting
Data
(At-
tached)
















(For EPA Use Only)
Accession Numbers
Assigned
















87

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I M1.1t

•••*. and  **f*ly  of Iho formwUUd
     ** praihicl. M*y n*| con*ld*r »ny
      »• *nppatllng Ib*
•*Mp| lit* fallawlni dtl*:
  III Tli* 
Dane  la ••ceiUln Ih* omoiinl »n4
Icrme of cainp*ne*l|an lo bo p*ldj *n4
  III Th* *|tpllr.*nr* n*m*. *ddt*M,
 ftnJ Iclcplian* rnimli*r.
  III If |h* •pplleenl** product con.
 Ulne »ny *c!U* litMcdlMt olh*r lh*n
 |h*i* lh*l «i* iireeenl *a|*ly heceue*
 of Hi* |iiroi|toi*llaii Inlo Ih* proilnct,
 ili|iht| fariniilkllnn. pi Mip Of
 oilier  r*|lel*i*«l  |K*Hr.liU
            fiani  •nnlh*r  |irmhic*».
      ii.. ......It*.M! •(••li •!•• rM«<»lti
  Illl*
wllb | III • I •• I* eueh edlte bigr**-
•nl. end Hie application *h*l| ooi|Ubj
en, ecknawlademaitl lh*t for purpaetf
of flPIIA eectlan llpN|NDI lite epp||.
C*tlon relle* en lend eny |*eul|lni tee.
(•Italian ehanld be regarded  ee || ||
weie beeed an.llie Admhtbttalor* can-
•ldce*llan oil Hi* follawhif iUrV.
  III All dela eubmlllad or epeclll
tiled  by the *ppllc*n| In Btippa|| of
  111 r*ch pih*r (Urn of *?•!• h Ih*
       '
  III Oaneerne the ptonetlle* or *(f*c||
ol *ny *ne|i *ct|r* |pe,r*itl*nl; eml .
  Illl le on* of Ih* lype* of del* |he|
fir A would raqiilt* lo bo BiibmllUd for  .
•cfontlfl* review by KPA If Hi* appli-
cant eoueht  Ih* |nl|lel  fMlelrotbn
under rim A. flecllon lUNII el ft
pioducl wllli oampaelllan end Inland-
Od naa* M«|tllca| |o HIM* propoeed for
HI*  applicant**,  product,  under Ib*
dale reqiihemenl* In oiled on Ib*
dele TM'A*  epp'iovc* Hi*  ei
                    Cbtjfmb  •/ fM
I Mill

 «•»  i         ....     .-.- .  „
|al«L limy  peelklde prodiulf *h*l|
l»er • Ulicl  oofcilalnlno;  Ih* Inform**
Han •pecllled by, lite Ael and Ih* r*|t|*
(•Hen* In Ihb t*iL Tli*  eonlepb) e| *
|*b*l  htuil eliow obeilf *n4  Ploml-
panlly HI* following!
 Ill Hi* nemej brand, or |r*demeik
under which th*,prodMd  b enld •• pr**
•eillMd In paragraph |b| of Ihb *re>
lion;
  Illl  Th* name end  *ddr***  of Ih*
producer. rigbtVenl,  or pereon  for
whom piedMotil ke  pNacitbod, 1*111*1"*
•Mplifolellhbkecllon;
  Illll Tli* net clmlenU  e*  pre*crlbt4
In perMi*ph Id! of  Ihb ••alien;
  l!r)   The   |«mhi*t   |*|le|r*ll*ll
number ee preeeilbed In peieitaph f*l.
of Ilile ••clloit;
  1*1  Hi*  produclnf  «*J»blbhiMii|
number •• prcM|lb*4 In  p«l*f teph III
•f Ihb Mclleiii              '
  (•II An Inircdlenl •Ul*m*nl *• ple>
•cilbeil |q f*l*ir*ptt.  Ill *| Hilt
lion:
                                                                                                                    APPENDIX  IV-1
                                            CKopf*! |—f *jv(i*nMenlol holei||en A|*ncy

                                            •  1*111 Wirnlni or proeoHlloMry *UI*>
                                            pienl* *• pr*ec||b*d |t| p»i*|t*pli Itil
                                            p| ihb *ecl|on:                      i
                                              |*llll The  dlrecllon* for nee *• pr*-
                                            •cilbe4 In p»iB|tBp|| III of ||ib eec|lon;
                                              Hit The Me* c|*Mllle*ll*ni*l •• pr
                                            *e|lb*d |n per«ii*pli III el IliU Mclla
                                              III ffoni|n«nc« and fcolklllly. ||| A
                                                                               *
                                                                             an.1
                                                                             A||
                                            •ante. •Ulcmcnl*.
                                            (lent. ilceUne pr oilier |nfaim*|laii re-
                                            atilrcd on Ilia (•belln* )>y !!•• Act  or;
                                            |h* leiiiUllon*  |n Ilili p*i| miul  b*
                                            clceilv |e*lbl* la * petMMi w|||i norm*!
                                            llilan, f>nil ntuel lie  placed  will) *itc|t
                                            cane|i|c|iouencM (••  competed with
                                            •||i«r worde, *U|*mert|e. dcelBn*.  or
                                            •leplil* mailer  on  Ui« bbelhtit en4
                                            ••piMeed In eiich Ictroi M la lander ||
                                            |lh*|y lo b* lead end iiiideielaoil  by
                                            lit* pn|ln*ry |nillv|i|tul under ciulam*
                                            •ry COIM||||OIM ol pwrchee* »n4 IIB*.
                                              (Ill All reqiilf *4 |eb«l (••! mm|: 1
                                              IAI II* «el |n I point or '
                                                           id |eb«l Uei miu|:
                                                           I point or |M*er Irpel
                                               III) Appear en f clear conlroelliif
                                             bacVfiaiin4;»n4
                                               IOI Hot b* obeaiir*4 Pr crowded.
                                               Ill (L*N0M*0« fa ft* uteit Al| teqiilred
                                             lebct or labeling \»n\ e|itl| e|ipeer In
                                             Hie  rcmlUli laniueie.  However. Ih*
                                             Aeenef may rcqulr* or Hi* applicant
                                             inay propoeo edilll|one| !••! In olhar

                                             pro|
                                             Ing.
                                               (II ffoeemeMf  «/ Looc|-l|l OeneroL
                                             Hi* lebel ehall appear on or bo *eeut*«
                                             If •llachce] lo Hi* Immcilbl* aoiilaln*
                                             tr of Ih* peellcld*  pia«liict.  Pof piif.
                                             PMC* o| Ihb  dccllen.  »n4 Iho mil-
                                             t>inndii| piovlilane of |ho Act. "•*•
                                               Gtcly •lUcheit" ehall mcen  that  •
                                               »e| crfn reeeonably bo oipecled I*
                                             |enieln *|||ied itmlng Hi* foroeceable
                                             Comlllleni *nd pailqd of lie*. If the ihv
                                             picdlel* con|elner |l cncloecd wllhln  q
                                             Wiapifer or oulelde  cenlelner Hiroilgh
                                            • wdlch Hie label cennol he elearly read.
                                             Hi* labc| tniiil aleo be eecnrely •!-
                                             Uchcd |o euc.li ouUld* wrapper  or win-
                                             lalner; If It |i * p.it pf ||M p«eheie M
                                             Miileieailly illi|||biiUa pr • -14 '
                                               HI) flint MM onil pf/icr bulk  con.
                                                   I-IAI Tr*mporfolloii. Wlille  «
                                                 lleMf pindiicl b |n lr»n*lt. (lie *u-
                            I lit !•

                    of •• era r«|u
|1*-llt.conc*inlnv Hi* |IOHHMH|*||MN
p| hauidau* m-.lciUI*. ond •pccll!* •!
ly l|io** piovlilon* cancel mini ||t« U
belln«. m»illni •ml iiUc*idln« al |i»t
•itfatl* |n*l*il*l* Mini Hi* •iilililii c«i
Ifliifl Iliein. ilclln* Ilia likt
fequlicinciil*. In ••MMIon. «|i«n
|C|ltl*f«d  |ic*l|cld* |i|04luc|
pot|c4 In  •  l*nk MI. l»nk liurk  or
*lti*r piobll* 01 poiltlil* bulk itiultin
•I. • copy  ol Ilia •cci|i|til Ubol mini
b* olUclwd  la ||»«  •Mi>|iln«  |«*|ici*.
»nd lc|l wllli Hi* cwiuUnc* •! l|i« Mm*
p| <|e|l**f y.
  ID) SfufatM,  Xyrtcn pcalldd*  |no.|
Mel* oro slated In  bulk c*nUln«i«.
«r|i*ll»r malill*  or •Ull*n*iy. *likh
Iftnaln In  III*  *M*lailr ol Hi* n»r. •
Copy ol Ilio UUI ol Ulxllm. |nrlii.llnf
fII *pprapiUlo i|lf«c|lun* far »••. •hall
b* *CMlicly •lUclictl la III*  caiiUlnci
In |li* ImmcilUU tlclnlly al l|i* 
-------
 I rill A IHM iU;amaol IBM* In Math a
 •y •• U |h>a • fab* M BablMdlng IBB*
 iB*tl*n U llw puicbatar*
 IVlllt l-abal dltclalmaia tfllfcll MMt*
 r 4*li*cl lr*m labeling alalaaaauU ia-
 nil ad undar Ih* Act and HIM* |cgula«
(out;
 III I ClaraM M  U  III*  aafaty •! In*
 ttllclda or lla Inaraillanla. Including
UUincnlt Mich aa "MIX," "nonpaban-
 \u."  •*ita|ihi|iiilaiM.w •'haiintoaa'*  *r
JMMlUfel* U hMMtana and pala* »IIH
 r without Midi * qualifying p|i|aaa M
*>haii utad at directed"; *ne)
 IB) If on numerical and/ar comnata-
!«• tltlamenla MI  Ilik  aaftly •( ||i«
 loducl. Including but no| llmllad la:
 U|  MltewUI|i«  all natural  fngi*df>
  IMt «4-ri*ia4ii

b* •juatlfbd by! *ppr*ptbl* vordfaM
•uoh •* Tackcdtfay • t •." Ttblilhul.
•d by t • •.- of -flald by • • f to t|ia»
that Ilia narn* if not Hit! of |h* p.*.
ducar.          i
  Idl  Jfef ftMlaU or *u*ivr« */ «•«.
fall ||| Tha nit welihl or puttura
of coqUnl aliall ba ••duel** of vmp.
   Cm or oilier mMailab and elialj b*
   i avaraga canlenl milaea ••p||c|||*
flalad at • mlnliMim quant II y.
  fl|  |f Hi* pcatlcIJa b a flquld. |b*
Ml  content eUlament  ahaD  b* b|
   bat of Ihuihl lAeaeut* al If IT WC|'
    •hall ba ••pikeaed In con»enlbiu|
Ameileam nolle of flub) ounce*. HitU.
         .• A.liAA^.             *
 till "Among III* |BM» i*Hl* ftham|*
 la lm«*uM
 «•! final piloted labels* in B«MPI
 i  |iio*|dad  In patagrapH laMMIII *J
 lilt  ttcllaii.  rinal  pilnlad,  (abating
 n»| b* ettbmlllad •ltd acccplAd pilof
 a  lealtliallan. HoMBVar. final pilnUd
labeling naad nal ba aiihmlllad tmlfl
ill * II lelial !••!• liat* baan piovblon-
»lly accepted by Mi* Agenay.
 fill Clceily legible repiodnettoM Ot
plinU •ciliMllMtt whl b* *c««pl*d far
|llllltllBl  lebcb  Midi BB Ill0e*.tflk>
•fliecned jUicflly ••»•• •'••• •» metal
r>nlai.'»ci« w/laiga bag 01 ilium UUla.
Illicit IBIIIOhllcllOlM IMial b* «f !»!«••
Illin ititiadiwll0il outllly.
                   «r Iffl4«m«rl. Ill
                                      •naila. and ••llatia.
                                      1 III if |li* pMlUMa b Mil.) 6f
                                      114. flacoiia ar pifMUika4. «f U
                                      lura  af llquM and Mild. Hi* ti.l can-
                                      Ian!  aU|amaiit aliall ba  |M |ai*M *f
                                      Valaht   aipf*M*«|   •*  •vafabipaU
                                       ounila and •uncaa.
                                       Ill In *N caaca, nat canlant •hall b*
                                       UU4 In |«rm« a| Ih* |at|cal aiilUtlt
                                      linfl*. | •.. "I pauiid U Min*a«* |«|b«r
                                       han"Minc«a.>>'
 .III In addition In Ib* raqulrad imlU **
•paalflad.  «•!  conlcnt anay  ba •!•
Maaacd In ma|i|a unlla.
  Ill  failallan *bav* tabilmtun *an-
 anl M aiMind an *»at aia la paiyalu|-
                                      la
                                      M
          «L  t»*   «
          . lM*nil. M l»ilMMik
          - pcillabU  |iiMlucl to
•lull •|>|i»»r •» Hi* Irml p»n*l •! UIA
      '
  111 ||a nftM*. brtnd. «r
  ay »|ip*«r •« ill* l»l>«l vltlctll
  III ft MM u mUl(B »IM| •d«••« BII llw Ulwl •in! Ui« itiUlunl It
 lial III* piai|iw«r. *l If Ik* IUIIM •( Hi*
 |Ki«an fnr •tr>~ "'• RMlhiM*  »•••
 |n«i|iic«4 *|M'M      !•• Ulicl, U Mini
  la only to Id* aalenl lha| It fepia-
•enl* dtfletloti unawaldabl* In gaad
  Cinulaclililng  piaallc*.   Vailellen
  I4w o al*|ad minimum M nal permit-
led] In no MM •hall th* ft**i*g* «*•>
lcn( of Hi* packaita |« ft alilpmenl fall
bale}*; Ilia alalad Malaga content.
  I*) fradHcf  uelilralldH  ntmlttv
Tli* reiUliallan number aeilintd I*
||ia B>cillc|da  pioducl  at  Ilia  lima af
laabliallan tli*l| appear on Iha I
piacaded by Hi* phieca MKI*A I
Italian II*..- or Iha pliiata "tirA lle|.
Mo." Tli* r*|bliallan ntimbar tlull ba
eel In lypa of • tlte and elyle tlmllti I*
•l|iar pilnl on that pail of Ih* |tbtl
pn which II appaMB and ehall pin ptr-
•Hal la |L Th* railillallan  number
ftnd HI*  faqiilrad -Idenllfylng  pluMt
•hall nal appear In •ueti  • manner al
|o  auiiatt  or  Imply |*conimandilletj
•r anilmtement ol lit* piottxcl Jiy l|if
Agency.         "
  III frtwIiKliig ••f.gMltnmtNfl !•»(»'
                                                         .
                                       fralla* numltr. Hi* ptadiwlni nUV
                                       lilimonl  |*|ltliallan numUr prc
                                       ••I iir.ibi piiuM -r-r* **", «r
                                                                         R-t
                                                                                                                         (oontlnueil)
  Ctfltfl-

  f|na| aUtWUbmtnl M «.|ibh III* piad-
  pel vaa praditced may appear In any
  •iillabb locallan MI III* |abel or ftmm*.
  4U|a canlelntr. |t muel appear an Ih*
  wrapper or ouleld*  container of Hi*
  neckei* |f Iha KPA Beleblbhmanl lag-
 •liUtllnn  number  PH Ilia ImmcdleU
  raplalncr  cannot  Ua  clcaily  read
  |hioii|l| •uch viappar or coiilalnar.
   Ill iNBMilltMf tlalfM«Hl~||| n«N«r-
  •t T|M |eual of *acli pcellclda  product
  mutt beef » alalamant which canlelna
  ||ia nema and peiecnlaga by welihl af
  Itch acllra Innadlaiit. Iha  |A|a| par-
' ccnlBi* by w«l||i) of el) Ineil  faiBredl-
  inlt; tnd II |h* petllclile canlalna ar-
  Itnla In apy faim. o alalameiit of Hi*
  pticenleict of |ola| and walei-aehibl*
  »l**nb caUnltlad  aa elemental ar-
  atfile. Tlia acllo* Iniiaitlenle mutt b*
  4(tlimUd by Ih* (era "eet|»e  Innedl-
  tnle" and Ilia hi«i| Ingradlenla by Ilia]
  leim "(nail Innedlenle." qr Ih* •|niu'
  |*r fauna of (haea |»rma whan appia-'
  pilel*. nalh laim*  ahal| ba  In |h*
i- tame lyp* tlu. ba allpned |o Iha earn*
  kiaiejit and ba aojually pram|n*nl. Tlia
  •Ulcmant -fncil Inueillcnla. nanaL b
  nal rtqiilitil lor ncellelde* w||lch can.
  Itln |0tt  paiceiil  «cl|v* |nBiMl|eiil*.
  llnltet Hi*. Innadlenl •lalameut b •
  •am*ltla analyela of Ilia pcellclda. |h*
  Itim -analytic* ahill not be need •• *
  bcedlnf far Ilia lnBtedlcn| eUlcmenl.
  .•' . 'Bl!1'11" 0/lnpiBdleof tlal*M«ni
  III Ilia, liifiadlent eleleinent  |e nor-
  pielly Mjiuliad on Ih* fianl penal of
  Ib* libel. || Ihet* b an ouleld* cAn-
  Jtlntr  or wieiipar |hroiiBh which Iha
  Iniiedltnl elkUmcnl cannot ba claaily
  Ift4. Iha Intfadlenl elalement miw|
  tue appa^r «.| knr.U oiitalda tonlelner
  •r wiBniier. || 1Kb eU* *r loim of |h*
                                                                                  ' lh- lll«l1"en»
                                                                                                            on Hi*
                                                                                            *'
                                                                                               >ai*H*l «ati  olbar
                                                                                               »n which U appaai*.
                                                                                 4  km.!  «« i»..jly .lltllnmU.1,1*
                                                                                        .   '.  ».6t U |»Ue*d bi Ilia
                                                                                        '" "  •»•  •
                                                              „
                                                           iiwro ktftii., f«|
                                                                                                                                                 I H1.lt
                                                                                                                             nun* may b* naad .IM. only
                                                                                                                     If II to vail tnown. If no
                                                                                                                                     .
                                                                                                                     I'M  bam aalablbtiad.  Ih. <|..mlc.|

                                                                                                                     SSTit*1^  ^ U lttil1  '•» "° «•-
                                                                                                                     fill Ilia IIM  of • ||*4c
                                                                                       IIM of • ||*4cNiaik 01 piopil
                                                                               •Ury iiam* ba paimllltd IM.UM. .,«•,
                                                                               nam* IM btan accapUd aa * comman
                                                                               naiiia by Ih* 4dmliil.|,.iar uwlci Iha
                                                                               aulhof lly of Utcllon llUMti
                                                                                    Sl«l«n|an|| ay iMrcanfaact Tlia
                                                                                    nlMe* of Iniudlcula tli.ll  ba
                                                                               •lalad In laima ol «alt|,| |o «(|a|,|.
                                                                               Ilia aum al |iaicanla|M af Iha acllva
                                                                               fiid Iha |nai| InHadlaMa tliall ba IB*.
                                                                               TaicanlBiaa aliall na| ha a«|ii*M«l by
                                                                               ft lania of vahin aucli aa "M U%.- ||
                                                                               |h* |itca of |ha patllelda luoducl aia
                                                                               •Bpiaaiad a* «tUhl ol acllva liiBit.ll
                                                                               •ill par  unl| ataa, o alalantanl al Iha
                                                                               »*l|h| *f «cl|v* Ingiadlcnl  iict  unit
                                                                               lAliim* af |ha |i*elUhla  fiNOiiilalloi*
                                                                               •hall  aUo  appfar  In  Ilia |nBiedlenl
                                                                               •leUmcnl.

                                                                               Th* ttatoanlagc* given ehall bo aa'p/a-
                                                                               *l*a at poatlbla |alballnB  Bo«.l menu.
                                                                               faalnibi* piacllca. If |b«ie mey ba tin-
                                                                               ftyoldabla vaibllon between meiiula*.
                                                                               luting balcliaa.  ||i* «elu* alelcd lur
                                                                               •acli  aatlva faigtadlanl ah*l| ba Ilia
                                                                               |awM| pei*anlaBa which May h* piee-

                                                                              •   III .l>«f«rforaf|*aj.  Pcellcbtct which
                                                                               •hang* In chemical compotlllon'el|.
                                                                               nlflcahUy |niul meet Iha fallowhig U-
                                                                               baling rc^nlicinenle:-
                                                                                 III In caeca whcia It b daicimlnad
                                                                               Ibet » paaltolda formulallaii change*
                                                                               chemlcel  compoellun atBnl|lcan!ly.
                                                                               Iha pioiluat mutt  tiaar Iha fallowing
                                                                               •lalaman! In o prominent path Inn on
                                                                               Iha labaU ''Not  |or t.le or lit*  aller
                                                                               |da|al.M
                                                                                 Illl Th* Mo4ua| mm! meet all |eU|
                                                                               fUlma up |a Iha *ipli*||on lime hull-
                                                                               •alad on III* |ebt|.
                                                                                 Ill f«*i| (ndicatlenli. The  admlnlt-
                                                                               Iralor may ramilr* Ida iiama of any
                                                                               (nail Ingiadleiillal |o b* Idled In Ida
                                                                               Intredlent Blelamanl II ha iU|«imlnet
                                                                               Ibet aiien hitiadlanlUI m»» pne* ft
                                                                               httard I* men «r Iha anHianiNrnt.

                                                                               (laltMinlt.  lUatilud  weinhut<>Vii4
                                                                               lifccaiitlonary  ualen»eii|* cnncainlni
                                                                               Ib*  panml  *raaa  ul lokbulAdcal
                                                                              . liiitnl litcliiillng liBtaid |o  chf
                                                                               •iivlionmcntkt litfiki.l  • •.•' Uvt|
                                                                               flit n|ci>| |i Mid (alt d i.	

-------
  1 Id*
       * iMiilr
       Uticlliii
  HIM* i*qu|f«4 MI Ih* frml p»n*l of
              •n4 I|IOM »|ikh  •*•»
                •• »An**lfI*  r coiilf o*
i  M«uU CMiMinln*; *OM*MI. pU*4
                                           M-MMMMHIf
 i i '%• «  |i» ^% i

 ! .    l|| ffHMon .	. -.,	
 ' .' Ta*f«f|M r«f«»0fv f7An'pullcl4* pio4-
 1 1 ncU MMlIm Hi* «ill*iU of
i!
 • <  panel Hi* tliiul «»*id "n«nt«f." In *4-
  *  dllliin If Hi* piodiicl w*« *ulfn«4 lo
    -   - -   - -     - «„ ||l( {,••!• of II*
                    Uimtl loilclly I**
                     *n4  *v* loctl  *f-
    feclil ||i* wonl ••Ptthan" •lt*ll *P»«»r
    In t«4 mi • Iwcfciiaund of dltllnclly
    fmilMillng calar *n4 (It* «fcwll *n4
    CI*«I|IMIM *h»ll *pp**r  hi *
    piOMliMlly lo Hi* void Hp*ba
     11)1 TfciUlftf C*ltt*n If.  -. -  .
    cld« proilucla MMlIni Ih* cilUrl* of
    T*«lc|ly O.l««aiy II *l»ll h**r on  l|t*
 |i  fionl |Miul III* •lin*l
  \
      li:i Toilally C*f If. -r .   .
! 5 • eld. pl..lud. MMM lh.V«»V!» •!
                                     ••hpt vliMi Ih* J|*Mf 4al*mtM|
                                     Ih4l *uc|t UUIIng If MCMM» U pi*>
                                     V*A| |HIIM**mbl* *4«MB* *fl*tU *f)
                                     |H*n M |ll* •IHllMIMMll. In »• MM
                                     •hall  m*r* l|i*n '•«• liimian |i*Mi4
                                     •lin«J void *PP**I on Ih* Itenl D*IK|
                                     •UUUI.       •,            q
                                       Illl CMI4 h*Hr4*.*i«niliiA Bvny PM-
                                     IUI4* pimliicl Ulicl *lwll b**» Ml Hi* •
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-------
                                                                                                APPENDIX IV-2
                             LABELING REQUIREMENTS OP THE FIFRA,  AS AMENDED
  LABEL ELEMENT
Product name

company name
and address

Net contents
EPA ESt. NO.

EPA Rag. No.
ing    enta
statement

Pounds ga  on
statement
Front pane
precautionary
statements
Keep Out or Re
of Children
(Child hazard
warn!  )
Signal word
APPLICABILITY
OF REQUIREMENT
All products

Al  products
Ai  products
Al  p

Al  p
3tS


CtS
          ts
L quid products
where dosage
given as Ibs.
ai unit area
Ail products
Al  products
All products
PLACEMENT
REQUIRED
Front panel
None
None
None
None
Front pane
Front panel
Front panel
Front panel
Front panel
ON LABEL
PKEb'UKKEU
Center tront
anel
Bottom rent
panel or end
of label text
Bottom tront
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediate y
following
roduct name
Directly be •M
the main
ingredients
statement
Above signa
word
Immediately
below child
hazard
war nil
COMMENTS

I registrant s not the producer, must
be qualified by "Packed for . . .,'
"Distributed . . .," etc.
May be m metric units in addition to
U.S. units
Must be in sun lar type size and run
arallel to other type.
May appear on the container instead of
the label.
Text must run para* 9 wfth" other text
on the panel.

Ail tront panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
                                                   93

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                                    APPENDIX IV-2 (continued)
1
ITEM
7C
70
7B.
a
8A
88
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
f
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to.
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products •
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category Is
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.
QJi

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                                 APPENDIX W-2 (continued)
ITEM
BC
9A
0C
10A
IOC
100
LABEL ELEMENT
Physical 'or
chemical
hazards
Restricted
block
Misuse
statement
Re-entry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
All pressurized
products, others
with flash
points under
150°P
All restricted
products
All products
All
cholinesterase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
statement of
classifica-
tion or
ahead of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Sane 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 USB
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
95

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                                                   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.

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

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

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

    D.  Flashpoint above
        150°F.
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 oc incinerate
container.  Exposure to
temperatures above 130°F
may cause bursting.

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

Flammable.  Keep away from
heat and open flame.

Do not use or store near
heat and open flame.

None required.

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                                               Appendix TV-4

       STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES

All products are required to bear specific label .instructions
about storage and disposal.  Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL.  Products
intended solely for domestic use need not include the 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.
                               97

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                                                 Appendix IV-4
                                                 (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,

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

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

B.   Pesticide Disposal Instructions!

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

1.  The labels of all products, except domestic use, must
    contain the statement, "Do not contaminate water, food,
    or feed by storage or disposal."

2.  Except those products intended solely for domestic use,
    the labels of all products that contain active ingredients
    appearing on the "Acutely Hazardous" Commercial Pesticide
    Products List (RCRA "E" List) at the end of this appendix
    or are assigned to Toxicity Category I on the basis of
    oral or dermal toxicity, skin or eye irritation potential,
    or Toxicity Category I or II on the basis of acute inhala-
    tion toxicity must bear the following pesticide disposal
    statements

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

    The labels of  all products, except those intended for
    domestic use,  containing active or inert ingredients
    that  appear on the "Toxic" Commercial Pesticide Products
    List  (RCRA "F" List)  at the end of this appendix or
    presently meet any of the criteria in Subpart C, 40 CFR
    261 for a hazardous waste must bear the following pesticide
    disposal  statement:
                               98

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                                                  ppen ix iv-«
                                                 (continued)

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

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

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

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

C.  Container Disposal Instructions

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

    1.  All products intended for domestic use must bear one
        of the following container disposal statements:
Container Type Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
                               99

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                                                Appendix IV-4
                                                (continued)
   2.  The labels for all other products must bear container disposal
       instructions, based on container type* listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
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.
Container Type
Statement
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^-, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording).
    1-Manufacturer may replace this phrase with one indicating whether
    and how fiber drum may be reused.


  2. The labels for all other products must bear container
     disposal instructions, based on container type, listed
     on the first page of this Appendix.
                              100

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                                                 Appendix IV-4
                                                 {continued)


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

      •Acutely Hazardous* Commercial Pesticides (RCRA "E" List)
                   Active Ingredients, (no inerts):

Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-l2-ethylthio)ethyl] phosphorodithioate
      (disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Diraethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Pamphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomy1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
                               101

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                                                 Appendix IV-4
                                                 (continued)


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

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

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                                                 Appendix IV-4
                                                  (continued)


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

 Acetone
 Acrylonitrile
 Amitrole
 Benzene
 Bis(2-ethylhexyl)pthalate
 Cacodylic acid
 Carbon tetrachloride
 Chloral  (hydrate)
 Chlordane (technical)
 Chlorobenzene _
 4-Chloro-m-cresol
 Chloroform
 o-Chlorophenol
 4-Chloro-o-toluidine hydrochloride
 Creosote
 Cresylic acid
 Cyclohexane
 Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c,d)-pentalen-2-one
     (kepone, chlordecone)
 l,2-Dibromo-3-chloropropane  (DBCP)
 Dibutyl  phthalate
 S-3f3-(Dichloroallyl diisopropylthiocarbamate  (diallate, Avadex)
 o-Dichlorobenzene
 p-Dichlorobenzene
 Dichlorodifluoromethane (Freon 12*)
 3,5-Dichloro-N-(1,1-dimethy1-2-propynyl) benzamide  (pronamide,Kerb)
 Dichloro diphenyl dichloroethane  (ODD)
 Dichloro diphenyl trichloroethane (DDT)
 Dichlorethyl ether
 2,4-Dichlorophenoxyacetic, esters and salts  (2,4-D)
 1,2-Dichloropropane
 1,3-Dichloropropane (Telone)
 Dimethyl phthalate
 Ethyl acetate
 Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
 Ethylene dibromide (EDB)
 Ethylene dichloride
 Ethylene oxide
 Formaldehyde
 Furfural
 Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
                                103

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                                                 Appendix IV-4
                                                 (continued)

         •Toxic* Commercial Pesticide Products  (RCRA "F"  List)
                         Active Ingredients!

Isobutyl alcohol
Lead acetate
Lindane
Naleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis  (3,4,6-trichlorophenol)   (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone  (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene  (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Sa£role
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane  (Freon 11*)
2,4,5-Tr i chlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid  (2,4,5-T)
Xylene
                                104

-------