Unrttd Statw
            Environmental Protection
            AoMicy
Officaof
pMicidasandToxieSubrtMKM  September 1988
           540/RS-88-121
            WMhington OC 20460
vvEPA
            PaiticidM
Guidance for the
Reregistration of
Pesticide Products
Containing TERBUFOS
as the Active Ingredient

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                             OMB Control No.  2070-0057
                             Expires 11/89
         REVISED GUIDANCE FOR THE
   REREGISTRATION OF PESTICIDE  PRODUCTS

                CONTAINING

                 TERBUFOS
         AS THE ACTIVE INGREDIENT


             CASE NUMBER 0109

      CAS Registry Number 13071-79-9
EPA Pesticide Chemical Code  (Shaughnessy)
              Number 105001
              SEPTEMBER 1988
     ENVIRONMENTAL PROTECTION AGENCY

       OFFICE OF PESTICIDE PROGRAMS

         WASHINGTON,  D.C.  20460

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                        TABLE OF CONTENTS
I.     Introduction
II.   Chemical(s) Covered by this Standard 	  3
        A.   Description of Chemical
        B.   Use Profile
III.  Agency Assessment 	  5
        A.   Summary
        B.   Preliminary Risk Assessment
        C.   Environmental Profile
        D.   Pesticide Incident Reports
        E.   Tolerance Reassessment

IV.    Regulatory Position and Rationale	20
        A.   Regulatory Positions
        B.   Criteria for Registration
        C.   Acceptable Ranges and Limits
        D.   Required Labeling

V.    Products Subject to this Standard	30

VI.    Requirement for Submittal of Generic Data	  32
        A.   What are generic data?
        B.   Who must submit generic data?
        C.   What generic data must be submitted?
        D.   How to comply with DCI requirements
        E.   Registrant Requests Regarding Data
            Requirements and Agency Responses
        F.   Test Protocols and Standards
        G.   Procedures for requesting a change in protocol
        H.   Procedures for requesting extensions of time
        I.   Data Format and Reporting Requirements
        J.   Existing stocks provisions upon suspension or
            cancellation

VII.  Requirement for Submittal of Product-Specific Data  .   .  38

VIII.  Requirement for Submittal of Revised Labeling ......  39

IX.    Instructions for Submittal	39
        A.   Manufacturing use products (sole active)
        B.   Manufacturing use products (multiple active)
        C.   End use products (sole active)
        D.   End use products (multiple active)
        E.   Intrastate products

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                            APPENDICES
I.    DATA APPENDICES	    43
      Guide to Tables	    44

      Table A	    47

      Table B	    69


II.   LABELING APPENDICES  	    74

      Summary of Label Requirements and Table   	    75

      40 CFR 162.10 Labeling Requirements  	    85

      Physical/Chemical Hazards Labeling Statements  ...    90

      Storage Instructions 	    91

      Container Disposal Instructions  	    92

      .Pesticide Disposal Instructions  	    93


III.  BIBLIOGRAPHY APPENDICES  	    94

      Guide to Bibliography	    95

      Bibliography 	    97


IV.   FORMS APPENDICES 	    Ill

EPA Form 8580-1    FIFRA §3(c)(2)(B) Summary Sheet ....    112

EPA Form 8580-6    Certification of Attempt to Enter Into
                   an Agreement with Other Registrants for
                   Development of Data	    113

EPA Form 8580-4    Product Specific Data Report  	    114

EPA Form 8570-27   Generic Data Exemption Statement  .  .  .    116

EPA Form           Certification With Respect to Citation
                   of Data	    117

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                GLOSSARY OF TERMS AND ABBREVATIONS


ADI     Acceptable Daily Intake.  Also known as the Reference
        Dose or RfD.

ai      Active Ingredient

ARC     Anticipated Residue Contribution

CAS     Chemical Abstracts Service

CFR     Code of Federal Regulations

CSF     Confidential Statement of Formula

DCI     Data Call-in Notice

EEC     Estimated Environmental Concentration.  The estimated
        pesticide concentration system in an environment, such
        as a terrestrial ecosystem.

EP      End-Use Product

EPA     U.S. Environmental Protection Agency

FIFRA   Federal Insecticide, Fungicide,, and Rodenticide Act

FFDCA   Federal Food, Drug, and Cosmetic Act

Ib ai/A Pounds of active ingredient per acre

LEL     Lowest-Effect Level

MATC    Maximum Acceptable Toxicant Concentration

MPI     Maximum Permissible Intake

MRID    Master Record Identification (Number).  EPA's system of
        recording and tracking studies submitted to the Agency.

MP      Manufacturing-Use Product

NPDES   National Pollution Discharge Elimination System

NOEL    No-Observed-Effect Level

OPP     Office of Pesticide Programs

OES     Office of Endangered Species, U.S. Fish and Wildlife
        Service
                               111

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PADI    Provisional Acceptable Daily Intake



ppm     Parts Per Million



RED     Reference Dose



TMRC    Theoretical Maximal Residue Contribution
                                IV

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I.     INTRODUCTION

       This document is a revised Registration Standard for
the subject chemical,  In its original Standard, issued in
June 1983, the Agency described the available data supporting
the registration of the chemical.   The Agency concluded that
additional data were necessary to fully evaluate the pesticide.
The Agency also set out label language which the Agency concluded
at that time were needed to ensure that products containing the
    Lciilrt remained in compliance with FIFRA.
       The Agency has since received and reviewed the additional
data and has revised its scientific and regulatory conclusions
in light of those data, other information on the chemical,.
and expanded data requirements promulgated in 1984, at 40 CFR
Part 158, for registration and reregistration of pesticides
under FIFRA.

       The revised Registration Standard, which supersedes the
earlier Standard, is the Agency's updated scientific assessment
of the pesticide, and the data needed to support its continued
(registration.  The Agency has also reassessed the tolerances
for the pesticide; that reassessment is included in this
Registration Standard.

       The Agency has also reviewed the current labeling for
products containing the pesticide, and has specified label
revisions which are necessary to remain in compliance with
FIFRA.

       The detailed scientific review, which is not contained in
i;hi. s document but is available upon request 1, focuses on the
pesticide active ingredient.   The scientific review primarily
discusses the Agency's evaluation of and conclusions from
available data in its files pertaining to the pesticide active
ingredient.  However, during the review of these data the
Agency is also looking for potential hazards that may be associated
with the EPs that contain the ai.  The Agency will apply the
provisions of this Registration Standard to EPs if necessary to
protect man and the environment.

       EPA ' s reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses.  See Section
IV - Regulatory Positions and Rationales.  Based on its regulatory
position, the Agency may prescribe a variety of steps to be
     scientific reviews and the EPA Compendium of Acceptable Uses
may be obtained from the National Technical Information Service,
5285 Port Royal Rd., Springfield,  VA. 22161.  Phone: (703) 487-4650,

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taken by registrants to maintain their registrations in compliance
with FIFRA.  These steps may include:

       1.  Submission of data in support of product registration ;

       2.  Modification of product labels;

       3.  Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;

       4.  Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;

       5.  Modification of uses or formulation types; or

       6.  Specification of packaging limitations.

       Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).

       In addition,  in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide.  If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
oC uses o£ the pesticide which have been determined to cause
unreasonable adverse effects on the environment.

       EPA has authority under the DCI provisions of FIFRA
section 3(c)(2)(B) to requice that registrants submit data to
answer our questions regarding the chemical, toxicological, and
environmental characteristics and fate of a pesticide.  This
Registration Standard lists the data EPA believes are necessary
to resolve our concerns about this pesticide.  These data are
listed in the Tables A, B, and C in Appendix I.  Failure to
comply with the DCI requirements enumerated in this Registration
Standard may result in issuance by EPA of a Notice of Intent to
Susp'end the affected product registrations.

       Registrants are reminded that FIFRA section 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they become
aware of such information.  Registrants must notify the Agency
of any information,  including interim or preliminary results of
studies, if that information suggests possible adverse effects
on man or the environment.  This requirement is independent of
the specific time requirements imposed by EPA for submission of
completed studies called in by the Agency and continues as long
as a product is registered under FIFRA.


                               -2-

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II.    CHEMICAL COVERED BY THIS STANDARD

       A.   Description of Chemical

           The following chemical is covered by this Registration
Standard:
           Common Name :   Terbufos
           Chemical Name:  S-[[(1,1-dimethylethyl)thio]methyl]0,0-
                           diethyl  phosphorodithioate
           Other Chemical Nomenclature:  S-[(tert-butylthio)methyl]
                           0,0-diethyl phosphorodithioate (IUPAC);
                           S-(t_-butylthio) methyl 0,0-diethyl-
                           phosphorodithioate  (CA, 8th Collective
                           Index) ;  S^-tert-butylmercaptomethyl
                           0,0-diethyl dithiophosphate
           Trade Names:   Contraven; Counter; AC 92,100;  CL 92,100;
                         and ST-100
           CAS Registry Number:   13071-79-9
           EPA Pesticide Chemistry Code (Shaughnessy) Number;  105001
           Empirical Formula:
           Molecular Weight:  288.4
           Chemical/Physical
             Characteristics oE a 35% Technical Grade (T) and the
             Purified Active Ingredient (PAI):
                    Color:  clear,  brownish (T)
                    Physical State:  liquid (T)
                    Odor:  mercaptan-like (T)
                    Specific gravity:  1.105 g/cm3 at 24 °C
                    Boiling point:   55 °C at 0,02 mm Hg (T)
                    Melting point:   N/A; technical grade in a
                                    liquid at room temperature (T)
                    Solubility:   > 110 g/100 mL in acetone, benzene,
                                 chloroform, 1,2-dichloroethene,  or
                                 ethaool at room temperature (T)
                    pH:   Data gap
                    Vapor pressure (PAI):  1.15 to 6.06 x 10~4 mm Hg
                                            at 25 °C,
                                           4.99 to 9.78 x 10"4 mm Hg
                                            at 35 °C,
                                           9.41 to 16.2 x 10~4 mm Hg
                                            at 45 °C.
                    Stability:  It is relatively stable in water
                                under neutral or slightly acidic
                                conditions but is subject to
                                hydrolysis under alkaline condi-
                                tions.  It decomposed on prolonged
                                heating at temperatures greater
                                than 120 °C (T).
                              -3-

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       B.  Use Profile

           Terbufos, an organophosphate insecticide/nematocide,
is principally used as an insecticide for corn rootworms on corn.
Other uses include use as a nematocide for lesion, spiral, stunt,
sting, stubby-root, and dagger nematodes on corn; and as an
insecticide for greenbugs on grain sorghum, sugar beet root maggot
on sugar beets, and seedcorn maggots, symphylans, wireworms. mai^e
billbug, southern corn billbug, and reduction of white grubs on
corn.

           Although terbufos is normally applied as a soil-
incorporated treatment using ground equipment, it may be applied
as a broadcast treatment on corn using either air or ground
equipment.   This use is limited to Nebraska,  New Mexico, and Iowa.

           There are no indoor nor domestic uses registered for
the chemical.

           There are 'two Federal registrations for products
containing terbufos:  one,  an MP containing 85.0 percent terbufos,
the other,  ^ granular EP containing 15.0 percent ai.  There are
several Special Local Need Registrations which were issued for 15
percent granular products.   There are no intrastate registrations,.
and no multiple active ingredient formulations registered,

           American Cyanamid Company, Agricultural Division, is
currently the  sole manufacturer of the technical product and
formulates oE  granular EPS in the United States.

       C.  Regulatory History

           Terbufos was first registered for use in the United
States in 1974.

           In  June 1983, the Agency issued the Terbufos Registration
Standard setting forth the  Agency's regulatory positions based
on available data and imposing additional data requirements to
support the continued registration of the chemical.

           The Terbufos Registration Standard was amended on
February 27,  1985 to require restricted use classification
labeling for the currently registered 15 percent granular product.
This restricted use classification was based on the high acute
oral and dermal toxicity to humans.

           The registrant has submitted data in response to the
Terbufos Registration Standard issued June 1983.  These data
have been evaluated by the Agency.  This revised Registration
Standard sets  forth the results of the Agency's reassessments of
the potential  hazards arising from the currently registered uses
based on these data.
                              -4-

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 III.   AGENCY FINDINGS

       A.  Summary

           The following  is a summary of  findings based on  the
 available data.  Please refer to the context of EPA's science
 findings, Sections B through E of this chapter, for  further
 details.

           1.  Technical  terbufos is highly acutely  toxic by the
 oral, dermal, and inhalation routes of exposure, placing it in
 Toxicity Category I for all three routes.

               Because mortality to the test animals would occur
 prior to the onset of any primary eye or  dermal irritation or
 dermal sensitization, these effects were  not evaluated for
 technical terbufos, and no further data are being required.

               The acute delayed neurotoxicity study in chickens
 was negative for acute neurotoxic effects.

           2.  Terbufos is a cholinesterase inhibitor, reducing
 plasma, brain, and red blood cell (RBC) cholinesterase (ChE)
 activity.  Based on the available dog feeding studies, the NOEL
 for plasma ChE inhibition and brain/RBC ChE, are 0.00125 and
 0.060 mg/kg/day, respectively.

           3.  Results of the available oncogenicity and mutagenicity
 studies are negative.  The Maximum Tolerated Dose (.MTD) was reached
 in the oncogenicity studies.

           4.  Based on the review of a three-generation rat study
 using concentrations of 0.25 and 1.0 ppm,  the reproductive NOEL
 for terbufos is considered to be 0.25 ppm.  At the 1.0 ppm dose
 level, there was an increased percentage  of litters with offspring
 deaths as compared with the controls.  Because these effects
 occurred at a dose level which is above the plasma ChE inhibition
 NOEL established for regulatory purpose,  an ample margin of safety
 exists.

           5.  Based on the review of a rat teratology study,
 the NOEL for.developmental effects has been tentatively set at
 0.1 mg/kg/day.  A teratology study in rabbits is needed to fulfill
 the Guideline requirements.   Based on the available rat study,
 the chemical does not demonstrate a teratogenic potential.

           6.  Based on results of a rat  metabolism study,  terbufos
was rapidly excreted within 168 hours of  administration.   Neither
 the parent compound nor its metabolites accumulated in tissues.

           7.  The use of terbufos poses  a potential risk to
 loaders and applicators;  and to persons reentering treated fields
 following nonsoil-incorporated broadcast  application of the
 chemical.  The major route of exposure is dermal and the  Agency
 is imposing the use of additional protective clothing, a reentry

                              -5-

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restriction, and a prohibition against non-soil-incorporated
broadcast application on corn prior to any detasseling operations.

           8.  Laboratory data show that t^cbufos is highly toxic
to avian species and to fish and aquatic invertebrates.  Results
of level 1 field studies demonstrate the potential for exposure
to nontarget organisms and that birds, mammals, reptiles, and
Cish may be killed by certain applications of terbufos.  Level 2,
or population studies, are required for the Agency to complete
its assessment of the impacts of terbuEos to nontarget terrestrial
organisms.  Aquatic organism field testing and residue monitoring
studies are required to complete its assessment of the impacts of
ter'oufos on aquatic organisms.

           9.  Due to the numerous gaps in residue chemistry
data, the Agency is unable to complete a tolerance reassessment
of terbufos.  The toxicology data requirements to support the
tolerances have been met with the exception of a teratology study
in rabbits.  The reference dose  (RfD) for humans is established  at
0.000125 mg/kg/ day and the TMRC is estimated to be 0,000052
mg/kg/day which is equivalent to 41.946 percent of the RfD.

          10.  The Agency is unable to assess the potential for
terbufos to contaminate ground water due.to the lack of  pertinent
environmental (rate data.

       B.  Preliminary Health Risk Assessment

           The  following assessment is based on EPA's  review of
the available data.

            1.   Acute  Toxicity

                Sufficient data are available to classify
technical teirbuEos as Toxicity Category  I due  to  its oral and
dermal toxicity with  an acute oral toxicity of  1.6 and 1.3  mg/kg
for male  and female rats, respectively;  and an  acute dermal
toxicity  of  0.81 and  0.93 mg/kg  for male and female rabbits,
respectively.   The available repeated  (21-day)  inhalation study
is sufficient to assess the  acute  inhalation toxicity  of terbufos.
Based on  the mortality observed  in the  female  rats  (2/10) and  the
ChE  activity depression observed in both sexes  at  inhalation
exposures which are  approximately  2000-fold less  than  the require-
ments  Cor Category  I  (£0.2  mg/L), technical terbufos  is classified
as Toxicity  Category  I  for acute inhalation toxicity.   Technical
terbufos  was highly  toxic to rabbits  in  primary eye and dermal
irritation  tests to  the extent  that all  rabbits died within 72
and  24  hours, respectively.   A  dermal sensitization study  is  not
available and none  is required  since  mortality would occur  before
sensitization.   In  an acute  delayed neurotoxicity study in  hens,
there  was no evidence of  acute  delayed  neurotoxicity at the 40
mg/kg  dosage  level  tested.


                               -6-

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           2.  Subchronic Toxicity

               In a 90-day subchronic oral study, Sprague-Dawley
rats were given terbufos in the diet at  0, 0.125  (0.00625 mg/kg),
0.250 (0.0125 mg/kg), 0.50 (0.025 mg/kg) and  1.00 ppm(0.05 mg/kg).
The systemic NOEL in this study was determined to be 0.25 ppm
based on a significant increase in the liver  weight associated
with an increase in the incidence of the liver extramedullary
hematopoiesis.  The NOEL for ChE inhibition was determined to be
0.25 ppm.  A subchronic 90-day oral study is  not required in the
dog because the available chronic dog study in conjunction with
the 4-week ChE dog study are sufficient  for establishing a ChE
NOEL for terbufos.

               In a subchronic dermal study,  rabbits were exposed
for 30 days to dosages of 0.004, 0.02, or 0.10 mg/kg of the technical
material.  At the lowest effect level of 0.10 mg/kg, edema and
erythema were reported.  The systemic NOEL was determined to be
0.020 mg/kg.  The ChE activity was not determined.

               Ninety-day dermal and inhalation studies are not
required because repeated dermal or inhalation exposure is not
expected to occur from the current registered pesticidal use of
terbufos.  Since there was no evidence of a neurotoxic effect in
the available acute neurotoxicity study,  the  subchronic neurotoxicity
study is not required.

           3.  Chronic Toxicity and Oncogenicity

               In a 2-year feeding/oncogenicity study, female
Long Evans strain rats were fed dosages of 0, 0.25 (0.0125 mg/kg),
1.0 (0.05 mg/kg) or 4.0 (0.2 mg/kg) ppm terbufos; male Long Evans
strain rats were fed dosages of 0,  0.25,  1.0, 4.0, or 8.0 (0.4
mg/kg) ppm.  Both systemic and ChE inhibition effects were observed
at the lowest dosage tested (0.25 ppm) and were dose-related.   A
NOEL could not be determined from this study.  There were no
oncogenic effects observed in this study.

               A 1-year rat study was conducted for purposes of
obtaining a NOEL and,  though no systemic effects were noted at
any dose (the highest dose tested was 1.0 ppm), the NOEL for
plasma and brain ChE was 0.5 ppm,  which was the mid-dose of the
study.  The 2-year rat study, when considered in conjunction
with the 1-year rat study,  satisfies the requirement for a chronic
toxicity study in a rodent species.

               In an 18-month oncogenicity study, in which groups
of 65 male and 65 female Charles River CD-I mice were fed technical
terbufos at dietary levels of 0, 3.0 (0.45 mg/kg), 6.0 (0.90 mg/kg),
or 12.0 ppm(1.80 mg/kg), there was no evidence that technical
terbufos had an oncogenic effect at any of the dose levels of
this study.  There was a possible slight increase in mortality as
well as a decrease in body weight gain in the high-dose group.


                              -7-

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               In a 1-year oral study, male and female dogs were
administered terbufos in capsule form at dose levels of 0, 15,
60, 90, or 120 ug/kg/day.  In this study, consistent, moderate
to large depressions in plasma ChE activity occurred in both male
and female dogs at all dose levels.  Although a NOEL could not be
determined for plasma ChE, the systemic NOEL was determined to be
120 ug/kg/day (the highest dose tested) since no systemic effects
(other than ChE)  were observed.  This study, when taken into
consideration with the 4-week dog plasma ChE study (described
below), satisfies the requirement for a chronic toxicity study in
a nonrodent species.  The NOEL for brain/RBC ChE in this study is
60 ug/kg/day.

           4.  ChE Inhibition

               A special 4-week ChE study was conducted in dogs
to define the dose-response of terbufos for plasma ChE.  In this
study, male and female dogs were administered terbufos in capsule
form at dose levels of 0, 1.25, 2.5, 5.0, or 15.0 ug/kg/day.  A
plasma ChE NOEL is sfet at 1.25 ug/kg/day.

               Dose-related plasma ChE inhibition was observed at
the two lower dosages of 5 and 1.25 ug/kg/day in both male and
female dogs.  In males, ChE activity was approximately 80 percent
of control values during all sampling periods at 5 ug/kg/day with
10 to ,15 percent (depending on which control values are used)
inhibition at 2.5 ug/kg/day.  No essential  inhibition of plasma
ChE occurred at the lowest dose of 1.25 ug/kg/day.  A similar
pattern of enzyme activity was observed in  the females, with 20
to 30 percent inhibition at the 5 ug/kg/day dose level for weeks
1, 2, and 4, and 10 to 20 percent inhibition at the 2.5 ug/kg/day
dose levels  (again depending upon whether concurrent or pretest
control values are compared).  No inhibition was observed at the
lowest dose tested of  1.25 ug/kg/day.

               Brain and RBC ChE activities were also evaluated
in this study.  Terbufos did not depress RBC ChE activity in
either male or female dogs at any dose or sampling time period
during the study.  This lack of depression  upon RBC ChE is in
agreement with the lack of effects at dosages of 15 ug/kg observed
in the 1-year dog study described above.  No compound-related
effect for brain ChE activity was observed  in either males or
females at  15 ug/kg.

            5.  Metabolism

               In male rats, terbufos was rapidly excreted as
the diethyl phosphoric acid and other polar metabolites (83%)
in urine within  168 hours of administration.  Terbufos and its
metabolites were not noted to accumulate in tissues.
                               -8-

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           6.  Mutagenicity

               The Agency has reviewed the available data and
results of these studies are summarized below.  No additional
mutagenicity data are required.

               Ames - With and without chromosomal activation,
                      the results were negative at concentrations
                      up to 1000 meg per plate.

               Acute in vivo Cytogenetic Assay - Terbufos did not
                      appear to cause any chromosomal aberrations.
                      The maximum doses tested were 1.8 mg/kg in
                      males and 1.5 mg/kg in females (higher doses
                      caused mortality).

               Dominant Lethal - In rats, the only apparent possible
                      compound-related effects on fertility were
                      in the high-dose group (0.4 mg/kg) where
                     ^the number of viable implants was slightly,
                     'but significantly, reduced at mating 9, and
                      implantation efficiency was significantly
                      lower at mating 7 as well as suggestively
                      (not significant) lower during matings 8,
                      9, and 10.

           7.  Reproduction

               The Agency evaluated a three-generation rat
reproduction study utilizing dosages of 0.25 and 1.0 ppm.  At
the 1.0 ppm dose level, there was .an increase in the percentage
of litters with offspring death in each of three generations as
compared with the controls.  A NOEL of 0.25 ppm for reproduction
effects was established for the study.   No additional reproduction
data are needed.

           8.  Developmental Toxicity

               The Agency evaluated two ca'obit teratology studies
and one rat teratology study.   The rat study in which pregnant
COBS® CD female rats were orally administered technical terbufos
during days 6 through 15 of gestation at dose levels of 0, 0.05,
0.10,  or 0.20 mg/kg/day is acceptable for assessing the potential
developmental toxicity of terbufos.   In this study,  the maternal
toxicity NOEL was established at > 0.2 mg/kg (HDT).   There was
an increase (not statistically different) in the number of early
resorptions and the number of litters with two or more resorptions
at 0.1 and 0.2 mg/kg, and increased postimplantation loss at
0.2 mg/kg.  The developmental toxicity NOEL was conservatively
established at 0.1 mg/kg and the LEL at 0.2 mg/kg.  Of the two
available rabbit studies,  one was considered invalid due to the
uncertainty as to the actual dose levels or test material admini-
stered to the rabbits during the test period.  The other study

                               -9-

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was considered unacceptable due to inadequate numbers of litters,
excessive maternal wastage, low insemination rate and/or implanta-
tion efficiency, high variation in reported doses administered,
and questions due to apparent gavage errors.  A new rabbit
teratology study is required.

           9.  Occupational Exposure Risk

               Limited field worker exposure data were gathered
in a study utilizing aerial application of 1.0 Ib ai terbufos
per acre to corn in Nebraska.  Since the dermal exposure data
collected during this study are not acceptable, primarily due
to the methodology used for assessing hand exposure, the foliar
dislodgeable residue levels (FDRs) on corn were used to calculate
the predicted levels of dermal exposure.  The FDRs were used in
combination with surrogate data to give estimated dermal exposure
levels of 118 ug/hour on 3 days after application and 73 ug/hour
on 7 days after application.  Utilizing an oral 4-week ChE inhibition
study in dogs with a ChE NOEL of 0.00125 mg/kg, and a safety factor
of 10, the calculated allowable exposure level for humans is
estimated to be 1.22 mg/hr for a 60 kg. person.  Since exposure
to fieldworkers would be primarily by the dermal route, a dermal
toxicity study  in test animals would be more appropriate for the
calculation of allowable human exposure levels and a special
21-day dermal study in rats to establish a NOEL for ChE inhibition
is being requested for this purpose.

                Environmental conditions, especially rainfall,
humidity, and dew have a strong influence on the rate of dissipation
of organophosphorous pesticides such as terbufos.  It is expected
that a broadcast application without soil incorporation of terbufos
in an arid environment such as the Southwestern States would
result in greater exposure to fieldworkers  in those States.  A
dislodgeable residue study to be conducted  in New Mexico is
therefore needed to estimate fieldworker exposure in the arid
Southwest resulting from aerial or broadcast application to corn.
At present, New Mexico is  the only Southwestern State in which
such a use of terbufos is  registered.

                The required protective  clothing for workers
reentering corn fields within 7 days of broadcast application
without  soil incorporation and the prohibition of nonsoil-
incorporated terbufos application prior to  detasseling activities
imposed  in this Registration Standard would mitigate adverse
effects  to workers reentering the treated areas pending submittal
and evaluation  of  the special dermal study  and the dislodgeable
residue  study described above.

                There  is little potential  for worker  reentry
exposure in  fields treated with a ground-incorporated application
of  terbufos.  Consequently,  no reentry  data or reentry  interval
are required to support these uses.


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       C.  Environmental Profile

           1.   Ecological Effects

               a.  Terrestrial Species

                   Based on acceptable laboratory data, technical
terbuEos is highly toxic to upland game birds on an acute oral
basis with a single-dose oral toxicity value of 28.6 mg/kg.
Based on two acceptable subacute dietary studies in birds,
technical terbufos is highly toxic to upland game birds with
subacute toxicity values of 143 and 157 ppm.

                   Two acceptable avian reproduction studies were
reviewed - one conducted with the bobwhite quail,  the other with
the mallard duck.  The quail study showed no reproductive effects
at concentrations up to 30 ppm in the diet.  In the mallard duck
study, there were no apparent effects at 1 and 5 ppm but there
was a slight reduction in embryo viability at 15 ppm.  This effect
was not considered to be statistically significant.

                   Te'rrestrial organisms may be exposed to terbufos
directly through ingestion of granules at or near the soil surface.
Based on a granular weight of 0.1 mg, it is calculated that it
would take 27 granules of a 15 percent terbufos product to reach
the acute oral toxicity of a small bird such as a Eield sparrow
with a weight of 0.0139 kg, if such a bird had the same sensitivity
to terbufos as the bobwhite quail.  However, in the available
toxicity screening studies it was found that 10 granules killed
all five redwinged blackbirds given this dose and killed two of
the five house sparrows receiving this dose.  A dose of 20 granules
killed four of the five blackbirds receiving this dose.  None of
the blackbirds receiving dosages of 1 and 5 granules were killed.
These results suggest that an approximate median lethal dose (the
dose that can be expected to cause death in 50% of the test animals)
for the redwinged blackbird is likely to be greater than 5 (0.075
mg terbufos), but less than 10 granules (0.15 mg terbufos) of the
15 percent terbufos product.  With 0.07 kg as the bodyweight oE
the blackbird, the calculated median lethal dose would be between
1.1 and 2.1 mg ai/kg bodyweight.  This would be 13 times the
median lethal dose of 28.6 mg/kg found in the previously mentioned
bobwhite quail acute oral toxicity study in which technical
terbufos was used as the test substance.  Since only granules
were tested in the screening studies, it was not clear whether
this increased toxicity was due to differences in sensitivity
between the two  test species or increased toxicity of the 15
percent granular formulation, or both.  While results of acute
oral toxicity testing using both the technical terbufos and the
15 percent granular product indicate thai; the 15 percent formulation
is less toxic than the technical, they do not address the species
sensitivity question.
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                   Based on an acceptable level 1 terrestrial
field study, a 15 percent granular formulation of terbufos caused
acute mortality of terrestrial nontarget species when applied to
corn fields.  In this study, 2 Ib ai/A applied at time of planting
as a soil-incorporated treatment resulted in mortalities to birds
and reptiles, while aerially broadcast unincorporated granules
applied to a maturing corn crop at one-half this rate resulted
in significant mammal, bird, and reptile acute mortality.  No
secondary poisonings were observed.

                   Other studies reviewed by the Agency include an
additional terrestrial field study in which a 15 percent granular
terbufos product was applied to corn fields at 1 Ib ai/A and an
outdoor pen study in which ring-necked pheasants were exposed to
soil treated with the 15 percent granular product at rates equiva-
lent to 1 and 5 Ib technical terbufos/A.  While results of the
field study implied minimal effects on wildlife, it was not
acceptable for use in a hazard assessment of terbufos.  Deficiencies
in the study include use of maximum application rates which were
lower than the currently registered maximum rate; a limited
number of searches for dead animals, and no analysis for ChE
inhibition.  While the results of the pen study also indicated
minimal hazard to the species tested, it was deficient in that
the exposure was not considered representative of the principal
route of exposure under conditions of actual use which is expected
to be dietary.  Since clean food and water were provided at all
times during the study, exposure to terbufos was principally
dermal.

                   Based on the adverse effects observed in the
acceptable level 1 study described above, the Agency is requiring
population studies or level 2 terrestrial field studies to assess
the potential effects on populations of birds, mammals, and
reptiles and to complete its evaluation of the potential hazard
to terrestrial nontarget species.

               b.  Aquatic Species

                   Based on acceptable laboratory studies,
technical terbufos is very highly toxic to freshwater fish and to
freshwater invertebrates on an acute basis.  The acute toxicity
values for freshwater fish range from 0.77 to 20.00 parts per
billion (ppb).  The acute toxicity for freshwater invertebrates
(Daphnia maqna) is 0.31 ppb.  Technical terbufos appears to be
highly toxic to marine/estuarine fish based on results of a
96-hour acute toxicity study on sheepshead minnow, and to marine/
estuarine invertebrates based on results of a 96-hour acute
toxicity study on mysid shrimp.  These studies deviated from the
recommended protocols, however, and are not adequate to completely
characterize the acute toxicity of technical terbufos to either
of these species.  There was no information available to characterize
the toxicity of technical terbufos to marine/estuarine molluscs.


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The acute toxicity studies with estuarine and marine organisms
are required because some of the crops (e.g., field corn and
sorghum) may involve use of the chemical on more than 300,000
acres in coastal counties and because use on these crops is
likely to result in runoff that may be transported to the habitats
of estuarine and marine organisms.

                   Based on results of an aquatic invertebrate life
cycle study using Daphnia magna, technical terbufos is extremely
chronically toxic to freshwater aquatic invertebrates with an
maximum acceptable toxicant concentration (MATC) in the parts per
trillion (ppt) range based on growth, survival, and reproduction.
The available information is not sufficient to completely charac-
terize the chronic toxicity of terbufos to fish in an early life
stage test.   The available test, which was conducted with rainbow
trout, is not acceptable because it failed to meet the requirement
that at least one test level must adversely affect a life stage.
This study is required because the lowest fish acute toxicity
value (0.77 ppb) is well under 1 mg ai/L; results of the initial
modeling show the EEC in water is greater than 0.01 of the acute
toxicity; the hydrolylic half-life is greater than 4 days at 5,
7, and 9; some degradates, based on their structure,  may have a
toxicity similar: to oc greater than that of the parent compound;
and due to terbufos1  broad and repeated use in corn,  the chemical
is expected to be transported to water from the intended use
site.

                   A Daphnia magna acute toxicity study and two
96-hour fish studies using the 15 percent granular formulation
were reviewed and found acceptable.  Based on the results of
these studies, the formulated product is very highly toxic to
bluegill sunfish, rainbow trout, and Daphnia magna with acute
toxicity values of 12.3,  59.7,  and 6.2 ppb,  respectively.

                   Aquatic organisms may be exposed to terbufos
through runoff of the granules or through transport of soil or
water containing residues of terbufos or its degradates.  This
potential exposure has been demonstrated by reports of a fish
kill incident.  During the conduct of the previously described
acceptable level 1 terrestrial field study,  an aerial broadcast
application to a corn field in the Chesapeake Bay region reportedly
resulted in an estuarine fish kill.  Based on the results of initial
modeling conducted by the Agency for the 1983 Terbufos Registration
Standard, aquatic EECs resulting from the soil-incorporated use
of terbufos may pose an acute hazard for freshwater and marine/
estuarine species.   Potentially greater hazards are likely for
aerial applications of terbufos granules since soil-incorporated
applications typically provide less exposure than aerial broadcast
applications.  The Agency used a computer model to simulate runoff
from granular applications of terbufos.   The EECs of terbufos in
the hypothetical ponds of the model ranged from 7.4 ppb on day
15, immediately after the second runoff event,  and declined to


                               -13-

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0.035 ppb by day 60.  Residues sorbed to benthic sediment were
3.7 ppb on day 26 and declined to 2.1 ppb by day 60.  The model
was not able to consider degradates, certain of which (based on
molecular structure) may be as toxic as terbufos itself.  On the
basis of terbufos toxicity to aquatic organisms, the EEC levels
may pose an acute hazard for freshwater and marine/estaurine
species.  Residue levels of concern were exceeded for 38 to
56 days out of a total of 56 days following initial pesticide
runoff.  The potential chronic hazard to freshwater invertebrates
may be even greater than the acute hazard based on results of the
previously described 21-day chronic (life-cycle) study which
showed Daphnia magna to be extremely sensitive to terbufos.

                   Although these theoretical calculations and
modeling indicate that the use of terbufos may result in adverse
effects to aquatic species, actual field monitoring data are not
available to support this finding.  Moreover, the environmental
fate characteristics of tecbufos are not accurately defined by
available data.  Thus the models can be used only on a limited
basis.

                   Acjuatic residue monitoring studies will be
required to determine actual residues in aquatic systems exposed
to runoff and spray drift.  Although these studies were previously
requested in the 1983 Terbufos Registration Standard,  their initi-
ation was delayed pending the Agency's recalculation of the EECs.
Prior to the completion of this task, reports of the above described
fish kill incident demonstrating the potential exposure to aquatic
organisms under actual field use conditions became available.  In
addition, several environmental fate studies previously found
acceptable do not meet current Guideline requirements and need to
be repeated.

                   .Based on new acute and chronic data as well as
the reported fish kills, aquatic field studies are required to
investigate the potential adverse effects to aquatic organism
populations of aquatic exposures to terbufos resulting from
drift and runoff of agricultural applications of the chemical.
These studies should be conducted on both freshwater and marine/
estuarine sites with corn as the crop.

               c.  Nontarget Insects

                   Since terbufos is registered only as a granular
formulation, no significant bee exposure is expected.

               d.  Endangered Species

                   There is sufficient information to indicate
that current registered uses of terbufos may adversely affect
endangered species.  Threshold levels of concern to aquatic
endangered species  (EEC >  1/20 acute toxicity value) are exceeded


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by terrestrial, soil-incorporated applications (due to runoff).
Potentially greater hazards are likely for aerial applications
of terbufos granules since soil-incorporated applications typically
provide less exposure than aerial broadcast applications.

                   Terbufos has been identified by the Office of
Endangered Species (OES), U.S. Fish and Wildlife Service (USFWS),
as being likely to jeopardize the continued existence of certain
endangered species when used on corn and sorghum.  Based on this
determination, OES specified reasonable and prudent alternatives
to avoid jeopardizing the continued existence of the identified
species.  EPA is working with USFWS and other Federal and State
agencies to implement the alternatives in a technically sound
manner.

                   Formal consultation will be initiated with
OES under Section 7 of the Endangered Species Act regarding the
potential exposure to endangered species resulting from the
registered use of terbufos on sugar beets.

           2.  Environmental Fate

               Results of an acceptable hydrolysis study indicate
that terbufos degrades with a half-life of 2.2 weeks.  Formaldehyde
was the major degradate detected in this study.  Results of an
acceptable aerobic soil metabolism study indicate that terbufos
degrades in silt loam soil with a half-life of 26.7 days.  The
major degradates detected in this study included carbon dioxide,
terbufos sulfoxide, and terbufos sulfone.

               Results of a field dissipation study, classified
as supplementary, indicate that terbufos residues have a half-
life of less than 40 days in field plots of loam soil located
near Arcola, Illinois, and sandy loam soil located near Greeley,
Colorado treated with a 15 percent granular formulation at
an application rate of 1 Ib ai/A.  The sampling protocol was
inadequate to accurately assess the dissipation.of terbufos
residues in field soil and a new study is required.

               The available data reviewed by the Agency are not
sufficient to fulfill data requirements nor to assess the environ-
mental fate of terbufos.  Four studies previously reviewed and
found acceptable under the 1983 Terbufos Registration Standard do
not meet the requirements of the Agency's current guidelines and
new studies are required.  These are:  anaerobic soil metabolism,
leaching, fish accumulation, and field dissipation.  In addition,
several new studies are now required due to the additional method
broadcast (air or ground equipment) application without soil
incorporation which was not registered at the time of the 1983
Terbufos Registration Standard.
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               Based on an inadequate data base, no definitive
conclusions can be made about the potential for terbufos to leach
to ground water.  Terbufos residues were reported to occur in
well-water sampling in Iowa and Minnesota.  These reports, however
have not been confirmed in the laboratory and a resampling of the
same Iowa wells a year later, in 1986, showed no detections for
terbufos or its degradates.  The earlier report of the Minnesota
well detection has been attributed to a point source and not to
normal agricultural application.  Because terbufos is so suscep-
tible to hydrolysis, there is some question about any laboratory's
ability to detect it or confirm a detection.  Terbufos has been
identified as an unstable analyte in the National Well Water
Survey.  Additional data are required to assess the mobility and
leaching characteristics of terbufos and its degradates.  These
data include leaching and soil dissipation studies.

               No ground water monitoring studies are required
at this time.  Pending receipt and evaluation of more complete
environmental fate information, ground water monitoring studies
may be required in the future.

       D.  Pesticide Incident Reports

           Data on occupational illness due to pesticide exposure
have been received from California,  which requires that all such
physician-treated illnesses be reported to the State.  There were
no physician-treated cases of terbufos poisoning from 1980 through
1986.  During this same period, there were no reported hospitalized
cases of occupational terbufos poisoning.  Based on a 12 percent
sample of the nation's hospitals, there were no observed cases
of hospitalization due to terbufos exposure during the time period
from 1971 through 1976.  The Terbufos Registration Standard
issued in 1983 included information obtained from the Pesticide
Incident Monitoring System (PIMS), which was utilized by the
Agency prior to 1982, and which showed 31 reports involving
terbufos.  The Agency concluded, as was stated in the 1983 Terbufos
Registration Standard, that carelessness and/or negligence appear
to have been important factors in most instances, and that strict
adherence to proper storage and application techniques as prescribed
in the label directions and precautions will minimize the risk of
potential adverse effects to humans and domestic animals.

       E.  Tolerance Reassessment

           1.  Tolerances Issued

               Tolerances have been established for combined
residues of terbufos and its ChE-inhibiting metabolites in or
on the raw agricultural commodities bananas, sugar beets, corn,
and sorghum (40 CFR 180.352).  No food additive tolerances have
been established for terbufos.  Canadian tolerances exist on a
negligible residue basis (at less than 0.1 ppm in human food)
for sugar beets and corn.  There are no Mexican tolerances and
no Codex maximum residue limits (MRLs) set for terbufos.  There-
fore, no compatibility questions exist with respect to the Codex
MRL.
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               The tolerance on bananas expires on  Apcil  27,  1990
because of the lack of a teratology study in a second species.
Should the Agency find that the new rabbit teratology study  is
acceptable, it will reassess the tolerance for bananas and,  if
appropriate, will establish a permanent tolerance for this commodity,

               The established tolerances for terbufos are
presently expressed in terms of terbufos and its ChE-inhibiting
metabolites without specifying the latter as phosphorylated
metabolites.  The Agency will propose revising 40 CFR 180.352 by
changing the wording to read:

"...terbufos... and its phosphorylated (cholinesterase-inhibiting)
metabolites:

               o  Phosphorothioic acid, j5-(_t-butyl-thio)  methyl
                  0,0-diethyl ester.

               o  Phosphorothioic acid, S-(t-butyl-sulfinyl)
                  methyl 0,0-diethyl ester.

               o  Phosphorothioic acid, ^-{_t-butyl-sulfonyl)
                  methyl 0,0-diethyl ester.

               o  Phosphorodithioic acid,. 3-(^_-butyl-sulf inyl)
                  methyl 0,0-diethyl ester.

               o  Phosphorodithioic acid, J3-(t_-butyl-sulfonyl)
                  methyl 0,0-diethyl ester."

               The Agency will also propose that the "(N)"
designation be deleted from the sugar beet roots,  corn grain,
and sweet corn entries under 40 CFR 180.352.  This designation
indicates that the preceding tolerance level was set at the
level of detection or on a negligible residue basis.  Tolerances
are no longer established on a negligible basis,  and such
designations are being systematically removed from 40 CFR 180.

               Because of the residue chemistry data gaps, the
Agency cannot conduct a tolerance reassessment until the required
data are submitted and reviewed.

           2.  Residue Data

               In the Terbufos Registration Standard dated June
1983, no outstanding data gaps were identified for residue chemistry.
However, subsequent amendments to registered uses for terbufos
and addenda to the Pesticide Assessment Guidelines (Subdivision
O) for Residue Chemistry have made it necessary to reevaluate
portions of the data base previously reviewed under the June 1983
Standard.  As a result, some of the original conclusions regarding
adequacy of the data and support  for tolerances have been modified
in this revised Registration Standard.

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                a.   Metabolism

                    Based  on  an  evaluation  of  the  available  plant
 metabolism  studies,  the Agency  concludes that  the nature  of
 residues  in  plants  is  adequately  understood,   The major portion
 (70  to  90%)  of  the  organosoluble  l^C-residues  present  in  the
 treated plant tissues  was characterized.   Of  the  phosphorylated
 metabolites, terbufoxon sulfoxide  and  terbufos sulfoxide  comprised
 <.  30 percent of the residues; and  terbufos sulfone and terbufoxon
 sulfone comprised £ 7  percent of  the residues.  The  major nonphos-
 phorylated  metabolite  which  comprised  <_ 30 percent of  the organo-
 soluble 14C-residues was  nonphosphorylated terbufoxon  sulfone  and
 the  minor ones  which comprised  £  13 percent were  nonphosphorylated
 terbofoxon  sulfoxide,  methane (t-butysulfonyl)(t-butylsulfonyl)
 and  methane  (t-butylsulfinyl) (methylsulfinyl).

                    The available poultry and  ruminant  feeding
 studies do  not  meet the current Guideline  requirements for  data
 depicting the metabolism of  terbufos in livestock.   The studies
 were not conducted  with radiolabeled material  not: were the  animals
 dosed at a  level high  enough for detection of  residues in the
 animal  tissues  and  milk.  The available rat metabolism study
 conducted with  radiolabeled  terbufos indicates  that  residues were
 rapidly excreted.   Fifty percent of the total  amount excreted
 during  the  study was excreted at the end of 15  hours.  Less than
 0.1  ppm remained in each  tissue at the termination of  the study.
 The  major metabolites  consisted of S-methylated series of metabolites
 Should  the  requested ruminant and  poultry  metabolism studies
 reveal  that  the metabolism of terbufos in  these animals differs
 from that in rats,  then a swine metabolism study would be required.

               b.   Analytical Methodology

                    An  adequate  analytical  method, published as
 method  I in  PAM, Vol.  II,  is available for the  collection of data
 pertaining  to the combined residues of terbufos and  its ChE-
 inhibiting metabolites in or on sugar beet tops and  roots;  corn
 forage  and  grain; and  sorghum.  Because the nature of  the residues
 in animals  is not adequately understood, no conclusions can be
 made regarding  the  adequacy  of  the available  methods for  detection
 of terbufos  residues of concern in animal products.  Upon receipt
 of the  required animal metabolism  studies, the  adequacy of  the
 available methods for detection of terbufos residues of concern
 in animal products  will be evaluated.  Adequate methodology and
 validation data for each of  the metabolites identified in the
 plant metabolism studies are available for only a few commodities.
Validation data pertaining to recovery of the  individual  metabolites
 listed  in the revised  tolerance expression proposed  by the  Agency,
 are  required for additional  representative plant commodities.
 Terbufos residues are  detected  by  the  Food and  Drug  Administration
 (FDA)-U.S.  Department of Agriculture (USDA) multiresidue  Protocols
 II and  III.  Additional testing is needed by  multiresidue Protocol
 IV.  In addition, each of the phosphorylated metabolites  must be
 tested by all four  FDA-USDA  multiresidue protocols.

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               c.  Residue Storage Stability

                   Available storage stability data indicate that
residues of terbuEos and its metabolites are stable in corn grain
and corn forage stored frozen for up to 5 months.  No data are
available depicting the stability of these residues in or on
other plant commodities and these data ace required.  In addition,
data are required depicting the storage stability of each separate
metabolite listed in the revised tolerance expression proposed by
the Agency.  The need for storage stability data pertaining to
terbufos residues of concern in animal tissues will be addressed
upon receipt and evaluation of the required animal metabolism
st ud i e s.

               d.  Field Residue Data

                   The available data on the magnitude and levels
of residue of terbufos in the individual raw agricultural commodities
are not adequate to determine the adequacy of the established
tolerances on sugar Beets,  corn, and sorghum and additional data
are required.

               e.  Processing Data

                   Data are available to demonstrate that terbufos
residues will not concentrate in sugar beet processed commodities.
Processing studies are lacking for corn and sorghum and are
required.

               f.  Meat, Milk, Poultry, and Eggs

                   The available poultry and ruminant feeding
studies, described in the metabolism section, show that no detectable
residues occur in eggs,  chicken tissues, milk, or cattle tissues
from animals fed exaggerated dietary levels of terbufos and its
ChE-inhibiting metabolites.  However, additional animal metabolism
data are required and a determination regarding the need for and
nature of tolerances for residues in meat,  milk, poultry, and
eggs will be made upon receipt and evaluation of these data.

               g.  FDA Monitoring and Surveillance

                   The FDA Revised Total Diet studies, as well
as the Surveillance and Compliance program for domestic and
imported commodities, employ methodology which is known to determine
terbufos.  No findings of terbufos were reported in Total Diet
study samples collected from April 1982 to April 1986.  A total
of 234 Total Diet food items were analyzed.  Information obtained
from FDA's Surveillance and Compliance program for samples
collected from the 1978 fiscal year to the 1987 fiscal year
indicate that a limited number of samples of various commodities
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were found to contain residues of terbufos.  Tolerance-exceeding
residues of terbufos were observed in field corn silage (1.16 ppm,
1.10 ppm).  Residues of terbufos were observed in the following
domestic commodities for which no tolerances exist:  meat (0.007
ppm, 0.14 ppm) and meal feed product (200 ppm); animal fat (from
a trace to 0.44 ppm) and bone meal (from a trace to 0.08 ppm);
chicken fat (0.27 ppm) and meat and bone meal (trace); and spent
malt barley (trace).  One imported commodity, chaom, was found to
contain 0.04 ppm.  A total of 100,824 samples were analyzed.

           3.   Reference Dose (RfD)

               Due to the lack of pertinent data, an RfD for
terbufos residues could not be established when the Terbufos
Registration Standard was issued in 1983.

               Data lacking for the chronic feeding, oncogenicity,
and teratology data requirements have been received and evaluated.
With the exception of the rabbit teratology study, which was found
to be supplemental as described under Section III A.I. of this
document, they are a.cceptable for use in determining an RfD.

               Based on the plasma ChE inhibition NOEL as defined
in a 4-week dog study (0.00125 mg/kg/day) and using a safety
factor of 10,  the RfD for humans is 0.000125 mg/kg/day.

               The current established tolerances for residues
of terbufos and its ChE-inhibiting metabolites result in a TMRC
of 0.000052 mg/kg/day and utilize 41.946 percent of the RfD.
This value utilizes the residue values of the published tolerances
and assumes that 100 percent of the crops were treated with
terbufos.

IV.    REGULATORY POSITIONS AND RATIONALES

       A.  Regulatory Positions

           1.   The Agency is not placing terbufos into Special
Review at this time.  Additional data are needed to complete the
Agency's risk assessment to aquatic and avian species, including
endangered species.  The Agency is conducting a comparative avian
risk assessment of various granular pesticides including terbufos.
When this assessment is completed, further regulatory action may
be taken.

           Rationale; Based on a high acute toxicity of terbufos  to
avian species and the current registered uses of terbufos, there
exists a ffigh potential for adverse effects to avian species from
exposure to terbufos granules at or near the soil surface.  This
potential for exposure to terbufos is demonstrated from results
of level 1 studies and is confirmed by bird kill incidents.  The
Agency is currently evaluating these data in the context of a
comparative risk assessment of granular pesticides which may pose
a risk to birds.  When this assessment is completed, the Agency

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will determine whether further regulatory action is necessary.

           Theoretical calculations indicate that the predicted
concentrations of terbufos in the aquatic environment resulting
from the registered uses of terbufos might expose aquatic species
to residue levels exceeding risk criteria for Special Review.
These calculations, however, are based upon models and may not
be indicative of actual residue levels in aquatic sites.  Upon
receipt and evaluation of the full-scale aquatic organism field
study and the aquatic residue monitoring data, a determination
will be made regarding further regulatory action.

           2.  A level II terrestrial field study, monitoring
studies in soil, water, sediment, and fish, and an aquatic organism
field study are required to support the continued registration of
terbufos.

           Rationale;  These studies are needed for the completion
of the Agency's assessment of the potential risk to both avian
and aquatic species resulting from registered uses of terbufos.
Refer to Section C.3.. in Chapter III of this document for a
discussion of the potential risks based on available data.

           3.  The Office of Endangered Species (OES) in the U.S.
Fish and Wildlife Service (USFWS) has determined that certain uses
of terbufos, including uses on corn and sorghum, may jeopardize
the continued existence of endangered species.  EPA is developing
a program to reduce or eliminate exposure to these species to a
point where use does not result in jeopardy, and will issue
notice of any necessary labeling revisions when the program is
developed.   No additional labeling is required at this time.
Labeling requirements issued in PR Notices 87-4 and 87-5 have
been withdrawn pending reissuance.

           In addition, the Agency is seeking OES evaluation of
the additional use of terbufos on sugar beets.

           Rationale:  Technical terbufos is potentially highly
toxic to birds, fish, aquatic invertebrates, mammals, and reptiles.

           In May 1987, EPA issued PR Notices 87-4 and 87-5 in
response to OES findings that certain pesticides, including
terbufos, jeopardized the continued existence of endangered
species.  Those PR Notices directed registrants to add labeling
to their products which referred users to additional information
that, in turn, explained limitations on use of terbufos within
the range of jeopardized endangered species.

           Subsequent to issuance of these PR Notices, EPA
identified  a number of significant technical errors and incon-
sistencies  in the information to which users would have been
referred.  Therefore, on January 26, 1988, the Agency issued


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PR Notice 88-1, which withdrew PR Notices 87-4 and 87-5 pending
development of a more focused program to protect endangered
species.  EPA is working to correct these errors prior to requiring
labeling to protect endangered species.  When that program is
fully developed, notice of any labeling necessary to protect
endangered species will be issued.

           4.  The Agency is imposing a 7-day reentry interval on
an interim basis pending submittal and evaluation of the required
reentry data and the special 21-day dermal study.  This reentry
labeling restriction is being imposed for the use of terbufos
on corn as an aerial application and as a broadcast (without soil
incorporation) application.

         •  Rationale:  Current data are not adequate to establish
a definitive reentry interval.  Establishment of an interim
reentry interval is based on the high acute toxicity properties
of technical grade terbufos and the high likelihood of exposure
to terbufos residues of workers who perform activities in the
treated site specified above.  Refer to Section B.9. in Chapter
III of this document- for a discussion of the available reentry
data and an assessment of the occupational exposure risk.

           5.  The Agency is imposing additional worker safety and
protective clothing statements for EPs containing terbufos.

           Rationale:  Though the Agency has had no recent reports
of terbufos poisoning incidents, it is concerned that exposure
could present a health risk to agricultural workers due to the
high acute toxicity of terbufos.  These additional protective
measures are being imposed to minimize this exposure.

           6.  The Agency is imposing a restriction against use of
terbufos as an aerial or broadcast application on seed corn prior
to any detasseling operations.

           Rationale:  This restriction is based on the high
acute toxicity properties of technical grade terbufos and the
high likelihood of exposure to terbufos residue of workers who
perform detasseling activities in seed corn fields treated with
an aerial or broadcast (without incorporation) application of
terbufos.

           7.  A special 21-day dermal study in rats is required to
support the continued .registration of terbufos as an aerial  or
broadcast application on corn.

           Rationale;  This study is needed for the completion of
the Agency's assessment of the potential risk to field workers
reentering fields following aerial or broadcast treatment without
soil incorporation with terbufos.  Refer to Section B.8.  in
Chapter III of this document for a discussion of the potential
risks based on available data.

                               -22-

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           8.  The Agency is deferring decisions concerning terbufos1
potential for contaminating ground water until information on the
environmental characteristics and fate have been submitted and
reviewed.

           Rationale:  The Agency is unable to complete its
assessment of the potential for terbufos to contaminate ground
water because the mobility characteristics of this chemical are
largely unknown.  Soil column leaching and field dissipation
data are incomplete and additional data are required.  The
limited data available appear to indicate that under most
environmental conditions terbufos would be unlikely to leach
to ground water in measurable quantities.  The available data
indicate that terbufos is not hydrolytically persistent with a
half-life of 2.2 weeks.

           9.  In order to meet the statutory standard for continued
registration, the Agency has determined that terbufos products
must bear revised and updated fish and wildlife toxicity warnings.
Specific wording is given in Section IV.D.
                    *
           Rationale;  Available data indicate that terbufos is
highly toxic to birds, fish, aquatic invertebrates, small mammals,
and reptiles.

          10.  The Agency is retaining the Restricted Use classification
for the currently registered 15 percent granular product.

           Rationale;  The Restricted Use classification was
imposed under the 1983 Terbufos Registration Standard, as amended
on February 27, 1985, based on the high acute oral and dermal
toxicity to humans.  There is no scientific basis for changing
the classification of terbufos.

          11.  The Agency has identified certain data that will
receive immediate review when submitted.

           Rationale;  Certain data are essential to the Agency's
assessment of this pesticide and its uses and/or may trigger the
need for further studies which should be initiated as soon as
possible.

           The following studies have been identified to receive
priority review either as soon as they are received by the Agency
or as otherwise indicated below:

          Data and When Reviewed                  Reason

          Toxicology

          Special 21-day Dermal Study in Rats     Assessment of
                                                  reentry risk


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Data and When Reviewed
83-3  Rabbit Teratology
Environmental Fate/Exposure
(Upon receipt of all five studies)
161-2  Photodegradation in Water
161-3  Photodegradation in Soil
162-2  Anaerobic Soil Metabolism
163-1  Leaching
164-1  Soil Dissipation

165-2  Volatility (lab)
Reentry Protection
132-1  Foliar Dislodgeable Residue
       Dissipation in New Mexi-co
Residue Data
171-4  Animal Metabolism in Ruminants
       and Poultry
Wildlife and Aquatic Organisms
 71-5  Field Testing - Mammals and
       Birds
 72-3  Acute Toxicity to Estuarine
       and Marine Mammals (upon
       receipt of both 72-3 and
       72-4)
 72-4  Fish Early Life Stage
                     *&'
 72-7  Field Testing-Aquatic
       Organisms
Reason
Tolerance
assessment
Assess leaching
potential
Assess leaching
potential
Assess leaching
potential
Assess leaching
potential
Assess leaching
potential
Tier study
Assessment of
reentry exposure
Tiered study
Avian risk
concern
Tier study
Tier study
Aquatic organism
risk concern
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          12.  While data gaps are being filled, currently registered
MPs and EPs containing terbufos may be sold, distributed, formulated,
and used, subject to the terms and conditions specified in this
Standard.  Registrants must provide or agree to develop additional
data, as specified in the Data Appendices, in order to maintain
existing registrations.

           Rationale:  Even when authorized under FIFRA sections
3(c)(2)(B) and 3(c)(7) the Agency may elect not to cancel or with-
hold registration though data are missing or are inadequate.
Issuance of this Standard provides a mechanism for identifying
data needs.  These data will be reviewed and evaluated, after
which the Agency will determine if additional regulatory actions
are necessary.

       B.  Criteria for Registration

       To be registered or reregistered under this Standard,
products must contain terbufos, bear required labeling, and
conform to the product composition, acute toxicity limits, and
use pattern requirements listed in
this section.

       C.  Acceptable Ranges and Limits '

           1.  Product Composition Standard

           To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain terbufos.
Each MP formulation proposed for registration must be fully
described with an appropriate certification of limits, stating
maximum and minimum amounts of the active ingredient and
inert ingredients which are present in products, as well as
impurities found at greater than 0.1%.

           2.  Acute Toxicity Limits

           The Agency will consider registration of technical grade
and manufacturing-use products containing terbufos provided that
the product labeling bears appropriate precautionary statements
for the acute toxicity category in which each product is placed.

            3.  Use Patterns

            To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
only for the commodities listed below.  The EPA Index to
Pesticide Chemicals lists all registered uses, as well as            }
approved maximum application rates and frequencies.
                               -25-

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           -Terrestrial, non-domestic, food uses on:

            corn: grain sorghum- and sugar beets.

       D.  Labeling

       In order to remain in compliance with FIFRA, products
must bear appropriate labeling as specified in 40 CFR 156.10
and this Standard, or must be revised to conform to those
specifications.  Appendix II contains information on label
requirements.

        No pesticide product containing terbufos may
be released for shipment by the registrant after November,
1989, unless the product bears an amended label which complies
with the requirements of this Standard.

     No pesticide product containing terbufos may be distributed
or sold after  November, 1990 unless the product bears an amended
label which complies with the requirements of this Standard.

     The following specific information must appear on the
labeling in order for products to remain in compliance with
FIFRA:

           1.   Ingredients Statement

           The ingredient statement for products must list the
active ingredient as:

Terbufos :  S-[[(1,1-dimethylethyl)thio]methyl]
           0,0-diethyl phosphorodithioate             	%
           2.  Use Pattern Statements

           All manufacturing-use products must state that they
are intended for formulation into end-use products for acceptable
use patterns.  Labeling must specify sites, which are listed in
Use Patterns, Section C.3.  However, no use may be included on
the label where the registrant fails to agree to comply with the
data requirements in TABLE A for that use pattern.

           Labels for MPs must bear the following identifying
phrase directly beneath the product name:

           "An insecticide and nematicide *j£or formulating
           use only."
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            In  the  directions  for  use,  the  following
 statement  regarding  acceptable  use patterns  must  appear  on
 MP  labels:

            "For  formulation into  end-use insecticide
            and nematicide products intended  only  for  (list
            acceptable  sites)."

            NOTE:   No use may  be included on  the label  where  the
            registrant  fails to  agree to comply with the  data
            requirements for that  use pattern.  Refer  to  Section
            B;  Use  Profile in  Chapter II for  the acceptable
            sites.

            3.  Precautionary  Statements

            Statements  for Manufacturing-Use  Products

            a.  The following  fish and wildlife statements are
 required to appear under the  "Environmental  Hazards" heading:

               This  pesticide is  extremely toxic  to fish and
 wildlife.   Do not  discharge effluent containing this product into
 lakes, streams,  ponds, estuaries, oceans, or public waters unless
 this product is  specifically  identified and  addressed  in a
 National Pollution Discharge  Elimination System (NPDES) permit.
 Do not discharge effluent containing this product to sewer systems
 without previously notifying  the  sewage treatment plant authority.
 For guidance, contact  your State Water Board or the Regional
 Office of EPA.
           Statements for End-Use Products

           a.  The following work safety rules and protective
clothing statments must appear on the label of end use products:

WORK SAFETY RULES

     REPEATED EXPOSURES TO CHOLINESTERASE INHIBITORS SUCH AS ARE
CONTAINED IN THIS PRODUCT MAY, WITHOUT WARNING, CAUSE PROLONGED
SENSITIVITY TO VERY SMALL DOSES OF ANY CHOLINESTERASE INHIBITOR.

     Persons working with this product should have frequent blood
tests of their cholinesterase levels.  If the cholinesterase
level falls below a critical point, no further exposure should
be allowed until it has been determined by means of blood tests
that the cholinesterase level has returned to normal.  Before
using this product, consult the National Pesticide Telecommuni-
cation Network for recommendations regarding such blood tests,
poisoning management, emergency treatment, and other information
                               -27-

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regarding the toxicity of terbufos.  The toll-free number for the
National Pesticide Telecommunication Network is 1-800-858-7378.

     If handled indoors, provide mechanical exhaust ventilation.

     Keep all unprotected persons, children, livestock, and pets
away from treated areas or where there is danger of drift.

     Do not rub eyes or mouth with hands.  If you feel sick in any
way, STOP work and get help right away.   See First Aid (Practical
Treatment) section.

     WEAR THE FOLLOWING PROTECTIVE CLOTHING DURING LOADING,
APPLICATION, EQUIPMENT REPAIR, EQUIPMENT CLEANING, AND DISPOSAL
OF THE PESTICIDE.

     Wear a protective suit of one or two pieces that covers all
parts of the body except the head, hands, and feet.  Wear chemical-
resistant gloves and chemical-resistant  shoes, shoe coverings, or
boots. > Wear goggles and a pesticide respirator approved by the
National Institute for Occupational Safety and Health (NIOSH) and
the Mine Safety and Health Administration (MSHA) at all times
except during application.

     If application is performed using an enclosed cab or cockpit,
the following protective clothing may be worn as an alternate:
long-sleeved shirt and long-legged pants; shoes and socks.
Chemical resistant gloves must be available in the cab or cockpit
and must be worn while -exiting.  All other protective clothing
required for use during application must be available in the cab
and must be worn when exiting the cab into treated areas.

     IMPORTANT!  Before removing gloves, wash them with soap and
water.  Always wash hands, face, and arms with soap and water
before smoking, drinking, or toileting.

     IMMEDIATELY AFTER COMPLETING WORK WITH THE PESTICIDE, take
off all clothing and shoes.  Shower using soap and water.  Do not
reclothe with contaminated clothing and  shoes.  Wash protective
clothing and protective equipment with soap and water after each
use.  Respirators must be cleaned and filters replaced according
to instructions included with the respirators.  Personal clothing
worn during use must be laundered separately from household
articles.  Clothing and protective equipment heavily contaminated
with terbufos must be destroyed according to State and local
regulations.  HEAVILY CONTAMINATED CLOTHING (CLOTHING ON WHICH
THE PRODUCT HAS SPILLED) CANNOT BE ADEQUATELY DECONTAMINATED.
                                                   4
     DURING AERIAL APPLICATION, HUMAN FLAGGERS ARE PROHIBITED
UNLESS IN A TOTALLY ENCLOSED VEHICLE.
                               -28-

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               b.  The following reentry statement and worker
protective clothing statements must appear on all products intended
for aerial application or broadcast application to corn:

               "Reentry into treated areas is prohibited for
7 days after the end of application unless the protective clothing
specified on this label for early reentry is worn."

               "FOR EARLY REENTRY INTO TREATED AREAS:  Use
protective suit of one or two pieces covering all parts of the
body except head, hands, and feet; chemical-resistant gloves and
chemical-resistant shoes, shoe coverings, or boots."

               c.  The following restriction must appear on products
intended for aerial or broadcast treatment for corn seed crops:

               "Do not use prior to any detasseling operations."

               d.  The following environmental hazards statements
must appear on all end-use products:

               "This pesticide is extremely toxic to fish and
wildlife.  Birds, and mammals utilizing treated fields may be
killed."

               "Do not apply directly to water or wetlands
(including swamps, marshes, bogs, and potholes).  Runoff and
drift from treated areas may be hazardous to aquatic organisms
in adjacent aquatic sites.  Do not contaminate water when disposing
of equipment washwaters.  Cover or incorporate granules that are
spilled during mixing and loading."

           6.  The following statement must appear on all end-use
products containing terbufos"

               "Not for use or storage in or around the home."
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            V.  PRODUCTS SUBJECT TO THIS STANDARD

     All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submittal or changes in composition, labeling or
packaging of the product.   The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.

    Products are subject to this Registration Standard as
follows:

A.  Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:

     1.  The restrictions (if any) upon use, composition, or
     packaging listed in Section IV, if they pertain to the
     manufacturing use product.

     2.  The data requirements listed in Tables A and B2

     3.  The labeling requirements specified for manufacturing
     use products in Section IV.

     4.  Administrative requirements (application forms, Confiden-
     tial Statement of Formula, data compensation provisions)
     associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard.  The Guide to
Tables in that Appendix explains how to read the Tables.

  Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard.  Table B lists product-specific data applicable
to manufacturing use products.  The data in Tables A and B
need not be submitted by an end use producer who is eligible
for the generic data exemption for that active ingredient.

  Table C lists product-specific data applicable to end use
products.  The Agency has decided that, in most cases, it
will not require the submittal of product-specific data for
end use products at this time.  Therefore most Registration
Standards do not contain a Table C.

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B.  Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:

    1.  The data requirements listed in Table A.

    2.  The labeling requirements specified for manufacturing
    use products in Section IV.

C.  End use products containing this pesticide as the
sole active ingredient are subject to:

     1.  The restrictions (if any) upon use, composition, or
     packaging listed in Section IV if they pertain to the
     end use product.

     2.  If eligible for the generic data exemption3, the
     data requirements listed in Table C.

     3.  If not eligible for the generic data exemption, the
     data requirements listed in Table A and the data require-
     ments listed in. Table C.

     4.  The labeling requirements specified for end use
     products in Section IV.

D.  End use products containing this pesticide as one of
multiple active ingredients are subject to:

     1.  If not eligible for the generic data exemption,
     the data requirements listed in Tables A and C.
3 if you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the generic data exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).

     Two circumstances nullify this exemption:

     1)  If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.

     2)  If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to the data
requirements in Table A.

                             -31-

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     2.  If eligible for the generic data exemption, the
     data requirements listed in Table C.

     3.  The labeling requirements specified for end use
     products in Section IV.
       VI.  REQUIREMENT FOR SUBMISSION OF GENERIC DATA

     This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec.  3(c)(2)(B).  It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4

A.  What are generic data?

     Generic data pertain to the properties or effects of a
particular active ingredient.  Such data  are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).

     Generic data may also be data on a "typical formulation"
of a product.  "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type.  These are  classed as generic
data, and are contained in Table A.

B.  Who must submit generic data?

     All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice).  EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and S 152.85) to submit
generic data in response to a DCI notice  if the registrant
who supplies the active ingredient in his product is complying
with the data request.

     If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data.  If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no  longer in compliance
with this data requirements notice, the Agency will consider
4 Registrations granted after issuance of this Standard will
be conditioned upon submittal or citation of the data listed
in this Registration Standard.

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that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe.  In
such cases, the Agency generally will not grant a time extension
for submitting the data.

     If you are not now eligible for a generic data exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm.  If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Generic Data Exemption
Statement.

     If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic data
relevant to the uses of your product if, at the time the
application is submitted, the data have been submitted to the
Agency by current registrants.  If the required data have not
yet been submitted,'any new registration will be conditioned
upon the new registrant's submittal or citation of the
required data not later than the date upon which current
registrants of similar products are required to provide such
data.  See FIFRA sec. 3(c)(7)(A).  If you thereafter fail to
comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).

C.  What generic data must be submitted?

     You may determine which generic data you must submit by
consulting Table A.  That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.

D.  How to comply with PCI requirements.

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

     1.  You will submit the data yourself.

     2.  You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself.  If you use this method, you must state who will

                             -33-

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submit the data on which you will rely.   You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be:  (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submittal.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it.  The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.

     If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number, as part of your 90-day response.  The
request must include the following information:

     a.  A list of the members of the consortium;
     b.  The name and address of the designated representative
         of the consortium, with whom EPA will correspond
         concerning the data;
     c.  Identity of the Registration Standard containing
         the data requirement;
     d.  A list of the products affected (from all members
         of the consortium); and
     e.  Identification of the specific data that the.con-
         sortium will be generating or submitting.

     The Agency will assign a number to the consortium, which
should be used on all data submittals by the consortium.

     3.  You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer.  You request that EPA not suspend your registration
for non-compliance with the PCI.  EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer.  [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]

     In order to qualify for this method, you must:

     1.   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, enclosed).
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     2.  Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt).  Your offer must,
at a minimum, contain the following language or its equivalent:

     [Your company name] offers to share in the burden of
     producing the data required pursuant to FIFRA sec.
     3(c)(2)(B) in the  [name of active ingredient] Registration
     Standard upon terms to be agreed or failing agreement
     to be bound by binding arbitration as provided by FIFRA
     section 3(c)(2)(B)(iii).

The remainder of your offer may not in any way attempt to
limit this commitment.  If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option.  In order for you to avoid
suspension under this method,  you may not later withdraw or
limit your offer to share in the burden of developing the
data.

     In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner.  If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant.will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe.  In such cases, the Agency
generally will not grant a time extension for submitting the data,

     4.  You request a waiver  of the data requirement.  If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so.  Your
statement must address the specific composition or use factors
that lead you to believe that  a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in  determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted.  A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.  The  Agency will respond in writing
to your request for a waiver.

     5.  You request that EPA  amend your registration by deleting
the uses for which the data are needed.  You are not required
to submit data for uses which  are no longer on your label.
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     6.  You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E.  Registrant Requests Regarding Data Requirements and Agency
    Responses

     All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
changes, or time extensions must be submitted in writing.
The original requirement remains in effect unless the Agency
has notified you in writing that it has agreed to a change in
the requirement.  While being considered by the Agency, such
requests for changes in the requirements do not alter the
original requirements or extend the time allowed for meeting
the requirement.


F.  Test Protocols and Standards

    All studies reqaired under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.  All testing must
be conducted in accordance with applicable Good Laboratory
Practices regulations in 40 CFR Part 160.

    The Pesticide Assessment Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA  22161 (tel: 703-487-4650).

    Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above.  When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158.  Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards.  The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
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 G.   Procedures for requesting a change in test protocol.

      If you will  generate the required data and plan to use
 test procedures which deviate from EPA's Pesticide Assessment
 Guidelines or the Reports of Expert Groups to the Chemicals
 Group,  Organization for Economic Cooperation and Development
 (OECD)  Chemicals  Testing Programme, you must submit for EPA
 approval the protocols you propose to use.

      You should submit your protocols before beginning testing,
 because the Agency will not ordinarily accept as sufficient
 studies using unapproved protocols.  A request for protocol
 approval will not extend the timeframe for submittal of the
 data, nor will extensions generally be given to conduct
 studies due to submittal of inappropriate protocols.  The
 Agency will respond in writing to your request for protocol
 approval or change.

 H.   Procedures for requesting extensions of time.

      If you think that you will need more time to generate
 the data than is  allowed by EPA's schedule, you may submit a
 request for an extension of time.

      EPA will view failure to request an extension before
 the data submittal response deadline as a waiver of any
 future claim that there was insufficient time to submit the
 data.  While EPA  considers your request, you must strive  to
 meet the -deadline for submitting the data.

      The extension request should state the reasons why you
 believe that an extension is necessary and the steps you
 have taken to meet the testing deadline.  Time extensions
 normally will not be granted due to problems with laboratory
 capacity or adequacy of funding, since the Agency believes
 that with proper  planning these can be overcome.  The Agency
 will respond in writing to any requests for extension of  time.


 I.   Data Format and Reporting Requirements

     All data submitted in response to this Notice must comply
 with EPA requirements regarding the reporting of data,
 including the manner of reporting, the completeness of results,
 and the adequacy  of any required supporting (or raw) data,
 including, but not limited to, requirements referenced or
^Included in this  Notice or contained in PR Notice 86-5 (issued
 July 29, 1986).   All studies must be submitted in the form of
 a final report; a preliminary report will not be considered
 to  fulfill the submittal requirement.
                              -37-

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J.  Existing stocks provision upon suspension or cancellation.

     The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision for the
registrant is not consistent with the Act.  Accordingly, the
Agency does not anticipate granting permission to sell or
distribute existing stocks of suspended product except in
rare circumstances.  If you believe that your product will be
suspended or cancelled and that an existing stocks provision
should be granted, you have the burden of clearly demonstrating
to EPA that granting such permission would be consistent with
the Act.  The following information must be included in any
request for an existing stocks provision:

     1.  Explanation of why an existing stocks provision is
     necessary, including a statement of the quantity of
     existing stocks and your estimate of the time required
     for their sale or distribution; and
                   •
     2.  Demonstration that such a provision would be consis-
     tent with the provisions of FIFRA.


   VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA

     Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect.  Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.

     If you have a manufacturing use product, these data are
listed in Table B.  If you have an end use product, the data
are listed in Table C.  As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time.  Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.

     In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D through J.  You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6.(cancellation of registration).

     Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.

                             -38-

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    VIII.  REQUIREMENT FOR SUBMITTAL OF REVISED LABELING

     FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses.  General labeling requirements are set out in
40 CFR 156.10 (see Appendix II - LABELING and SUMMARY).  In
addition, labeling language specific to products containing
this pesticide is specified in Section IV.D of this Registra-
tion Standard.  Responses to this Registration Standard must
include draft labeling for Agency review.

     Labeling must be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files.  Draft labeling must indicate the intended
colors of the final label, clear indication of the front
panel of the label, and the intended type sizes of the text.

     If you fail to submit revised labeling as required,
which complies with 40 CFR 156.10 and the specific instructions
in Section IV.D., EPA may seek to cancel the registration of
your product under FIFRA sec. 6.
               IX.  INSTRUCTIONS FOR SUBMITTAL

     All submittals in response to this Registration Standard
must be sent to the following address:

     Office of Pesticide Programs
     OPP Mailroom (TS-767C)
     Environmental Protection Agency
     401 M St., SW
     Washington, D.C.  20460

     Attn:  [TERBUFOS] Registration Standard

     All submittals in response to this Registration Standard
are non-fee items, including 90-day responses, protocols and
waiver requests, data, and revised labeling.  Submittals must
be clearly identified as being in response to the Registration
Standard.  Under no circumstances may Registration Standard
responses be combined with other types of filings for which
fees are required.

A.  Manufacturing Use Products (MUPs) containing the subject
    pesticide as sole active ingredient.

    1.  Within 90 days from receipt of this document, you
must submit for each product subject to this Registration
Standard:
                             -39-

-------
        a.  Generic Data Exemption Statement (EPA Form 8580-3),
    if applicable, or the "FIFRA Section 3(c)(2)(B) Summary
    Sheet" (EPA Form 8580-1), with appropriate attachments.

        b.  Confidential Statement of Formula (EPA Form 8570-4).

        c.  Evidence of compliance with data compensation
    requirements of FIFRA sec. 3(c)(l)(D).   Refer to 40 CFR
    152.80-152.99.

    2.  Within 9 months from receipt of this document you
must submit:

        a.  Application for Pesticide Registration (EPA
    Form 8570-1).

        b.  Two copies of any required product-specific data
    (See Table B).

        c.  Three copies of draft labeling, including the
    container label and any associated supplemental labeling.

        d.  Product Specific Data Report (EPA Form 8580-4).

     3.  Within the times set forth in Table Af you must
submit all generic data, unless you are eligible for the
generic data exemption.  If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.

B.  Manufacturing Use Products containing the subject pesticide
    in combination with other active ingredients.

    1.  Within 90 days from receipt of this document, you
must submit:

        a.  Generic Data Exemption Statement (EPA Form 8580-3),
    if applicable, or the FIFRA sec. 3(c)(2)(B) Summary
    Sheet, with appropriate attachments (EPA Form 8530-1).

        b.  Confidential Statement of Formula (EPA Form 8570-4)

    2.  Within 9 months of receipt of this document, you must
submit:

        Three copies of draft labeling, including the container
    label and any associated supplemental labeling.

    3.  Within the time frames set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption.  If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
                             -40-

-------
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.


C.  End Use Products containing the subject pesticide as sole
    active ingredient.

    1.  within 90 days from receipt of this document, you
must submit:

        a.  Generic data exemption Statement (EPA Form 8580-3),
    if applicable, or_ the FIFRA Section 3(c)(2)(B) Summary
    Sheet, with appropriate attachments (EPA Form 8580-1).

        b.  Confidential Statement of Formula (EPA Form 8570-4).

    2.  Within 9 months from receipt of this document you
must submit:

        a.  Two copies of any product-specific data, if required
    by Table C.

        b.  Product Specific Data Report (EPA Form 8580-4),
    if Table C lists required product-specific data.

        c.  Three copies of draft labeling, including the
    container label and any associated supplemental labeling.

    3.  Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption.  If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.


D.  End Use Products containing the subject active ingredient
    as one of multiple active ingredients

    1.  Within 90 days from receipt of this document, you
must submit:

        a.  Generic data exemption Statement (EPA Form 8580-3),
    if applicable, or the FIFRA Section 3(c)(2)(B) Summary
    Sheet, with appropriate attachments (EPA Form 8580-1).

        b.  Confidential Statement of Formula (EPA Form 8570-4).

    2.  Within 9 months from the receipt of this document, you
must submit:

    Three copies of draft labeling,  including the container
    label and any associated supplemental labeling.
                             -41-

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    3.  Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption.  If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
E.  Intrastate Products

    Applications for full Federal registration of intrastate
products were required to be submitted no later than July 31,
1988.  Unless an application for registration was submitted
by that date, no product may be released for shipment by the
producer after July 31, 1988.
                             -42-

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I.  DATA  APPENDICES
            43

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                        GUIDE TO TABLES

      Tables  A,  B,  and C contain listings of data requirements
 for  the  pesticides covered by this Registration Standard.

      Table A contains generic data requirements that
      apply to the  pesticide in all products, including
      data requirements  for which a "typical formulation"
      is  the  test substance.
          j
          ^
      Table B contains product-specific data requirements that
      apply only to a manufacturing use product.

      Table C contains product-specific data requirements that
      apply only to an end use product.

      The data tables are generally organized according to the
 following format:

 1.    Data Requirement (Column 1).  The data requirements are
 listed in the order in  which they appear in 40 CFR Part 158.
 The  reference numbers accompanying each test refer to the
 test protocols  set out  in the Pesticide Assessment
 Guidelines,  which  are available from the National Technical
 Information  Service, 5285 Prot Royal Road, Springfield, VA
 22161.

 2.    Test Substance (Column 2).    This column lists the
 composition  of  the test substance required to be used for the
 test, as follows:

      TGAI  = Technical  grade of the active ingredient
      PAI   » Pure  active ingredient
      PAIRA * Pure  Active ingredient, radio labeled
      TEP   » Typical end use formulation
      MP    » Manufacturing use product
      EP    = End use product

Any  other test  substances, such as metabolites, will be
 specifically named in Column 2 or in footnotes to the table.

 3.   Use pattern (Column 3).  This column indicates the use
patterns to  which  the data requirement applies.  Use patterns
are  the same as those given in 40 CFR Part 158.  The
 following letter designations are used for. the given use
patterns:                                ,*

     A » Terrestrial,  food
     B » Terrestrial,  non-food
     C » Aquatic,  food
     D = Aquatic,  non-food
     E = Greenhouse, food


                                        44

-------
     F =• Greenhouse, non-food
     G = Forestry
     H = Domestic outdoor
     I = Indoor
     N/A= There are no registered use patterns for which the
data requirement applies.
            •
Any other designations will be defined in a footnote to the
table.    ,

4.   Does EPA have data? (Column 4).   This column indicates
one of three answers:
         - EPA has data in its files that completely
     satisfy this data requirement.   These data may be
     cited by other registrants in accordance with data
     compensation requirements of Part 152,  Subpart E.

     PARTIALLY - EPA has some data in its files, but
     such data do riot fully satisfy the data
     requirement.  In some cases, the Agency may possess
     data on one of two required species or may possess
     data on one test substance but not all.  The term
     may also indicate that the data available to EPA
     are incomplete.  In this case,  when the data are
     clarified, or additional details of the testing
     submitted by the original data submitter, the data
     may be determined to be acceptable.  If this is the
     case, a footnote to the table will usually say so.

     NO - EPA either possesses no data which are
     sufficient to fulfill the data requirement, or the
     data which EPA does possess are flawed
     scientifically in a manner that cannot be remedied
     by clarification or additional information.

5.   Bibliographic citation (Column 5).  If the Agency has
acceptable data in its files, this column lists the
identifying number of each study.  This normally is the
Master Record Identification  (MRID)  number, but may be a GS
number if no MRID number has been assigned.  Refer to the
Bibliography Appendices for a complete citation of the study.

6.   Must additional data be submitted?  (Column 6).  This
column indicates whether the data must be submitted to the
Agency.  If column 3 indicates that the Agency already has
data; this column will usually indicate NO.  If column e
indicates that the Agency has only partial data or no data,
this column will usually indicate YES.  In some cases, even
though the Agency does not have the data, EPA will not
require its submission because of the unique characteristics
of the chemical; because data on another chemical can be used


                               45

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to fulfill the data requirement; or because the data
requirement has been waived or reserved.  Any such unusual
situations will be explained in a footnote to the table.

7.   Timeframe for submission (Column 7).  If column t
requires that data be submitted, this column indicates when
the data are- to be submitted, based on the issuance date of
the Registration Standard.  The timeframes are those
established either as a result of a previous Data Call-in
letter, or standardized timeframes established by PR Notice
85-5 (August 22, 1985).

8.   Footnotes (at the end of each table).  Self-explanatory.
                                    46

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               Table A
Generic Data Requirements for Terbufos
Test Use
Data Requirement Substance Patterns
§158.190 Product Chemistry
Product Identity
61-2 - Description of Beginning
Materials and
Manufacturing Process
61-3 - Discussion of Formation
of Impurities
TGAI

TGAI
Analysis and Certification of Product
t
62-1 - Preliminary Analysis of
Product Samples
TGAI
All

All
Ingredients
All
Must Additional Timeframe
Does EPA Bibliographic Data Be for
Have Data?1/ Citation2/ Submitted? Submissions/
Partial 00147534 Yes_4/

No — YesV
No — Yes6/
6 Months

6 Months
12 Months
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
TGAI
TGAI
TGAI
TGAI
All
All
All
All
TGAI All
No — YesT/
No — YesJV
Ho ~ YesV
N/A No8/
Yes 00142295 No
6 Months
6 Months
6 Months


                                00147534

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                                                       Table A
                                        Generic Data Requirements for Terbufos (cont'd)
Data Requirement
                                                                                    Must Additional
                                   Test        Use      Does EPA     Bibliographic  Data Be
                                Substance    Patterns   Have Data?"1/   Citation^/   Submitted?	
                                                                                                      Timeframe
                                                                                                         for
                                                                                                      Submissions/
§158.190 Product Chemistry

Physical and Chemical Characteristics (cont'd)

                                  TGAI         All
63-7  - Density, Bulk Density,
          or Specific Gravity

63-8  - Solubility

63-9  - Vapor Pressure

63-10 - Dissociation Constant
63-12 - pH

63-13 - Stability

Other Requirements

64-1 - Submittal of Samples
                                  TGAI or PAI  All
                                  PAI

                                  PAI
63-11  - Octanol/Water Partition   PAI
          Coefficient
                                  TGAI

                                  TGAI
All

All

All


All

All
No


Yes

Yes

No

Yes


Partial

No
00142295

00142295



00142295


00142295
YesV


No

No

NoV

No


Yes7/f10/

Yes7/
                                                                                                        6 Months
6 Months

6 Months
                                       N/A
 _1/ Although product chemistry data may have been submitted in the past, the Agency has determined that these data
    must be resubmitted for each pesticide.  New requirements have been introduced and previously submitted data must
    be updated.  Therefore, bibliographic citations for the old data are not applicable.  However, data submitted for
    the technical terbufos, registered under EPA Registration No. 241-241 in response to the requests made in the
    Terbufos Registration Standard dated June 1983, have been evaluated with regard to their adequacy in meeting the
   , requirements of 40 CFR 158.120.

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                                                       Table A
                                   Generic Data Requirements for Terbufos  (cont'd)

§158.190 Product Chemistry Footnotes  (cont'd)

 2/ These data citations pertain to the technical terbufos currently registered under EPA Registration No. 241-241 and
    may not be applicable to technical material which differs from that described herein.
 _3/ Due dates refer to the number of months following the issuance of this Registration Standard, unless otherwise
    indicated.
 V Complete information must be provided regarding the nature of the process  (batch or continuous), the relative
    amounts of beginning materials and the order in which they are added, the  chemical equations for each intended
    reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration
    of each step of the process, purification procedures, and quality control  measures.  In addition, the name and
    address of the manufacturer, producer, or supplier of each beginning material must be provided, along with
    information regarding the properties of each beginning material used to manufacture each product.
 j>/ A detailed discussion must be submitted of all toxicologically significant impurities and' all other impurities
    that are or may be present at >_ 0.1% by weight, based on knowledge of the  beginning materials, chemical
    reactions (intended and side) in the manufacturing process, and any contamination during and after production.
 6/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
    which a certified limit is required.  Complete validation data (accuracy,  precision) must be submitted for each
    analytical method used.
 7/ Physicochemical characteristics (color, physical state, odor, specific gravity, pH, and stability) as required
    in 40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D must be
    submitted.
 _§/ Not applicable; technical product is a liquid at room temperature.
 9/ Not applicable to the terbufos technical product.
10/ Required if the test substance is dispersible with water.

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               Table A
Generic Data Requirements  for Terbufos
Data
§158.
171-2
171-3
171-4





171-4






171-4









Test Does EPA
Requirement Substance Have Data?
240 Residue Chemistry
- Chemical Identity^/
- Directions for Use (See Index)
- Nature of the Residue PAIRA Yes
(Metabolism)
- Plants



- Nature of the Residue PAIRA and
(Metabolism) plant
- Animals metabolites
a. Rats Yes
b. Ruminants Partially
c. Poultry No
d . Swine No
- Residue Analytical TGAI and Partially
Methods metabolites








Must Additional
Bibliographic Data Be Timeframe for
Citation Submitted? SubmissionV



00036123,00062871, No
00069512,00079429,
00087686,00087688,
00087689,00087691,
00087692,00088210,
00131237,00133299



00087695 NO
00032636,00036241 YesJV 18 Months
Yes3/ 18 Months
ReservedV
00036123,00036127, YesjS/ 15 Months
00036129,00032646,
00036241,00036242,
00036246,00042020,
00042022,00049235,
00062872,00079431 ,
00087687,00087702,
00087704,00087724,
00088211,00129173,
00133299,00158614,
                                                                                     C
                                                                                     Lf

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                                                       Table A
                                        Generic Data Requirements for Terbufos  (cont'd)
Data Requirement
  Test
Substance
Does EPA
Have Data?
Bibliographic
  Citation
Must Additional
Data Be
Submitted?
Timeframe for
Submission1  /
§158.240 Residue Chemistry

171-4 - Storage Stability Data  TEP and
                                metabolites

171-4 - Magnitude of the Residue
         Crop Field Trials

      - Root and Tuber Vegetables
          Group

           Sugar Beet Roots          TEP

      - Leaves of Root and Tuber
          Tuber Vegetables Group

        - Sugar Beet Tops            TEP

      - Cereal Grains Group

        - Corn                       TEP
        - Corn (processed)           TEP

        - Sorghum                    TEP

        - Sorghum (processed)        TEP
                  Partially   00042021
                  Partially



                  No

                  Partially

                  No
              00039018,00042017,
              00042019,00087722,
              00137582,GS0109001
              00079430
                                   Yes6/
                  Partially   00036124,00036123,   YesV
                              00036129
                  Partially   00036124
                     Yes13/

                     Yes 1V
                                         15 Months
                                                     18 Months
                     18 Months



                     18 Months



                     24 Months

                     18 Months

                     24 Months
                                                                                            LO

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                                                       Table A
                                        Generic Data Requirements for Terbufos (cont'd)
Data Requirement
  Test
Substance
Does EPA
Have Data?
Bibliographic
  Citation
Must Additional
Data Be
Submitted?
Timeframe for
Submissionl/
§158.240 Residue Chemistry

171-4 - Magnitude of the Residue
          Crop Field Trials (cont'd)

      - Forage, Fodder, and Straw
          of Cereal Grains Group

        - Corn                       TEP
        - Sorghum                    TEP

171-4 - Magnitude of Residue in
         Meat/MiIk/Poultry/Eggs
                  Partially



                  Partially

                  Partially
              00039018,00042017,
              00042019,00087722,
              00137582,GS0109001

              00079430

              00032636,00036241,
              00087702
                     YesT7/

                     Reserved18/
                                                                                                    18 Months
                   18 Months
                                                                                                                            C\J
 _1/ Due dates refer to the number of months following issuance of this Registration Standard unless otherwise
    indicated.
 2/ The same chemical identity data are required as under §158.120, with emphasis on impurities that could
    constitute residue problems.  Refer to Product Chemistry Data Requirements tables.
 _3/ Metabolism studies using ruminants and poultry must be submitted.  Animals must be dosed for at least 3 days
    with methylene-labeled [14c]terbufos at a level high enough to permit identification and quantification of
    14c-residues.   Milk and eggs must be collected twice daily during the dosing period.  Animals must be
    sacrificed within 24 hours of the final dose.  The distribution and characterization of residues must be
    determined in  milk, eggs, liver, kidney, muscle, and fat.  Samples from these studies must also be analyzed
    using enforcement methods (including all FDA Multiresidue Protocols tl-IV]) to ascertain that the methods are
    capable of adequately recovering and quantifying all residues of toxicological concern.
 _4/ Data depicting the nature of terbufos residues in swine are also required if the required metabolism studies
    with ruminants and poultry reveal that the metabolism of terbufos in these animals differs from that in rats.

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                                                       Table A
                                  Generic Data Requirements for Terbufos (cont'd)

§158.240 Residue Chemistry Footnotes (cont'd)

 5/ Residues of terbufos must be tested in representative plant commodities by multiresidue protocol IV (available
    from NTIS under Order No. PB 86203734/AS).  Also, each of the phosphorylated metabolites listed in the proposed
    tolerance definition must be tested by all four multiresidue protocols.  In addition, methodology validation data
    pertaining to recovery of these individual metabolites from additional representative plant commodities are
    required.  Additional analytical data for detection of terbufos residues of concern in animal products may be
    necessary upon receipt and evaluation of the animal metabolism data as described in footnotes three and four of
    this table.
 6/ Data depicting the stability of terbufos residues of concern in or on sugar beet roots and sugar beet tops are
    required.  Samples bearing field-weathered residues or fortified samples must be analyzed immediately after
    harvest or fortification and again after storage intervals that are equivalent to those reflected in all previously
    submitted and currently requested residue data.  Storage conditions for the samples must also reflect previously
    submitted and currently requested data.  The chosen storage intervals must allow for unforeseen delays in sample
    analysis.  Data depicting the storage stability of each separate metabolite as listed in the proposed tolerance
    definition are required.  Upon receipt of the requested animal metabolism data, the need for storage stability
    data pertaining to terbufos residue of concern in animal tissues will be addressed.
 7/ The registrant must propose an appropriate tolerance for residues of terbufos and its cholinesterase-inhibiting
    metabolites in or on sugar beet roots based on data reflecting residues of terbufos in or on sugar beet roots
    harvested at normal crop maturity following at-planting application of the 15% G formulation at 4.4 Ib ai/field
    A (2.7 oz ai/1000 ft of row, 20-inch row spacing) drilled in 2 inches to the side and 2 to 4 inches below the
    seed.  Tests must be conducted in CA(23%), MN(20%) or ND(10%), ID(15%), and NE(7%) or CO(4%) or WY(3%)
    representing ca. 80% of 1985 U.S. sugar beet production (Agricultural Statistics 1986, p. 76).  The registrant
    must propose label amendments establishing a PHI for the postemergence banded application; this PHI must be
    reflected by the residue data submitted.
 8/ The registrant must propose an appropriate tolerance for residues of terbufos and its cholinesterase-inhibiting
    metabolites in or on sugar beet tops based on data depicting residues in or on sugar beet tops harvested at
    regular intervals through normal crop maturity following at-planting application of the 15% G formulation at 4.4
    Ib ai/field A (2.7 oz ai/1000 ft of row, 20-inch row spacing) drilled in 2 inches to the side and 2 to 4 inches
    below the seed.  Tests must be conducted in CA(23%), MN(20%) or ND(10%), ID(15%), and NE(7%) or CO(4%) or WY(3%)
    representing ca. 80% of 1985 U.S. sugar beet production (Agricultural Statistics 1986, p. 76).  The registrant
    must propose label amendments establishing a PHI; this PHI must be reflected in the data requested above and in
    all other data used to support the tolerance.

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                                                       Table A
                                   Generic Data Requirements for Terbufos (cont'd)

§158.240 Residue Chemistry Footnotes  (cont'd)

 £/ Data are required depicting terbufos residues of concern in or on grain from field corn planted in 30-inch rows
    and harvested at normal crop maturity following application of the 15% G formulation in a band at-planting at
    1.2 oz ai/1000 ft of row and incorporated postemergence in a band at 2.4 -oz ai/1000 ft of row (3.9 Ib ai/field
    A seasonal use rate).  Tests must be conducted in IL(17%) or IA(19%), IN(9%) or MI(3%) or OH(6%),  MN(8%) or
    WI(4%), and NE(11%) or KS(2%) collectively representing ca. 80% of 1985 U.S. corn production (Agricultural
    Statistics, 1986, p. 32).
10/ Data are required depicting terbufos residues of concern in or on grain of field corn grown in 30-inch rows and
    harvested 45 days after the last of three applications of the 15% G formulation, including a banded application
    at-planting of 1.2 oz ai/1000 ft of row, a postemergence banded application at cultivation at 1.2  oz ai/1000 ft
    of row, and a postemergence broadcast application of 1 Ib ai/A applied by aerial or ground equipment (seasonal
    use rate of 3.6 Ib ai/field A).  Tests must be conducted in IA, NE, and NM, the States having SLN  registrations
    that allow the postemergence broadcast applications.  Alternatively,  the registrant may elect to cancel the SLN
    registrations for postemergence broadcast use on field corn.
11/ Data are required depicting terbufos residues of concern in or on K+CWHR from sweet corn planted in 30-inch rows       «^j-
    and harvested at the PHI following the last of two applications of the 15% G formulation including a banded            IT)
    application at-planting of 1.2 oz ai/1000 ft of row and a postemergence incorporated banded application of
    2.4 oz ai/1000 ft of row (3.9 Ib ai/field A seasonal use rate).  Tests must be conducted in the States of FL(7%),
    IL(6%), MN(20%) or WI(20%), and OR(10%) or WA(10%) collectively representing ca. 70% of 1985 U.S.  sweet corn
    production for fresh market and processing (Agricultural Statistics 1986, p. 156).  The registrant must propose
    label amendments establishing a PHI for sweet corn K+CWR that is reflected in the data requested above.  The data
    requested for field corn grain will be translated to support the tolerance for popcorn grain.
12/ A processing study is required depicting terbufos residues of concern in products (starch, crude oil and refined
    oil from wet milling; grits, meal, flour, crude oil and refined oil from dry milling; and grain dust) processed
    from field corn grain bearing measurable, weathered residues.  If residues concentrate in any product,
    appropriate food/feed additive tolerances must be proposed.
13/ Data are required depicting residues of terbufos and its cholinesterase-inhibiting metabolites in  or on grain
    from sorghum planted in 20-inch rows and harvested at normal crop maturity following a single application of the
    15% G formulation at 2.4 oz ai/1000 ft of row (3.9 Ib ai/field A).  The insecticide must be drilled in at bedding
    or at-planting 1 to 4 inches below and 0 to 5 inches to the side of the seed.  Tests must be conducted in
    KS(20%), MO(11%), NE(14%), and TX(22%), collectively representing ca. 70% of 1985 U.S. grain sorghum production
    (Agricultural Statistics 1986, p. 52).
14/ A processing study is required depicting terbufos residues of concern in flour, starch, and grain  dust processed
    from sorghum grain bearing measurable weathered residues.  If residues concentrate in any product, appropriate
    food/feed additive tolerances must be proposed.

-------
                                                       Table A
                                   Generic Data Requirements for Terbufos  (cont'd)

§158.240 Residue Chemistry Footnotes  (cont'd)

j_5/ Data are required depicting terbufos residues of concern in or on forage and fodder of field corn grown in 30-inch
    rows and harvested 30 days after application of the 15% G formulation banded at-planting at 1.2 oz ai/1000 ft of
    row and incorporated postemergence in a band at 2.4 oz ai/1000 ft of row (seasonal use rate of 3.9 Ib ai/field
    A).  Tests must be conducted in IL(17%) or IA(19%), IN(9%) or MI(3%) or OH(6%), MN(8%) or WI(4%), and NE(11%) or
    KS(2%) collectively representing ca. 80% of 1985 U.S. corn production  (Agricultural Statistics 1986, p. 32).
16/ Data are required depicting terbufos residues of concern in or on forage and fodder of field corn grown in 30-
    inch rows and harvested 45 days after the last of three applications of the 15% G formulation, including a banded
    application at-planting of 1.2 oz ai/1000 ft of row, a postemergence banded application at cultivation of 1.2 oz
    ai/1000 ft of row, and a postemergence broadcast application of 1 Ib ai/A applied by aerial or ground equipment
    (seasonal use rate of 3.6 Ib ai/field A).  Tests must be conducted in IA, NE, and NM, the States having SLN
    registrations that allow the postemergence broadcast applications.  Alternatively, the registrant may elect to
    cancel the SLN registrations for postemergence broadcast use on field corn.
17/ Data are required depicting residues of terbufos and its cholinesterase-inhibiting metabolites in or on forage
    and fodder of sorghum grown in 20-inch rows and harvested at the PHI/PGI following a single application of the          K2
    15% G formulation at 2.4 oz ai/1000 ft of row (3.9 Ib ai/field A).  The insecticide must be drilled in at bedding
    or at-planting 1 to 4 inches below and 0 to 5 inches to the side of the seed.  The registrant must propose label
    amendments establishing a PGI/PHI that is reflected in the data requested above.  Tests must be conducted in
    KS(20%), MO(11%), NE(14%), and TX(22%), collectively representing ca. 70% of 1985 U.S. grain sorghum production
    (Agricultural Statistics 1986, p. 52).                                                                                  '
18/ Upon receipt of the required animal metabolism data, the need for and nature of tolerances for residues of
    terbufos and its cholinesterase-inhibiting metabolites in meat, milk, poultry, and eggs will be reevaluated.

-------
                                             Table A
                              Generic Data Requirements for Terbufos
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional
Data Be Submitted?
Timeframe for
Submissionl/
§158.290 Environmental Fate
Degradation Studies - Lab
161-1 - Hydrolysis
Photodegradation
161-2 - In Water
161-3 - On Soil
161-4 - In Air
Metabolism Studies - Lab:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
Mobility Studies:
163-1 - Leaching and
Absorption/
Desorption
163-2 - Volatility (lab)
163-3 - Volatility
PAIRA A Yes 00087694

PAIRA A Partial 000161567
PAIRA or TGAI A No
PAIRA or TGAI A No.
PAIRA A Yes 00156853
PAIRA or TGAI A No
PAIRA or TGAI — No
PAIRA or TGAI — No
PAIRA A NO
TEP A No
TEP A No
No

Yes2/
YesjJ/
Yes_3/
No
YesV
NoV
No6/
YesV
Yes£/
Reserved 9/


9 Months
9 Months
9 Months

27 Months


12 Months
12 Months

                                                                                                                 LO
(field)

-------
                                                        Table  A
                                        Generic Data Requirements  for  Terbufos  (cont'd)
Test Use Does EPA Bibliographic
Data Requirement Substance Pattern Have Data? Citation
§158.290 Environmental Fate
Dissipation Studies - Field:
164-1 - Soil TEP A No
164-2 - Aquatic (Sediment) TEP — No
164-3 - Forestry TEP — No
1 64-4 - Combination and — No —
Tank Mixes
164-5 - Soil, Long-Term TEP — No
Accumulation Studies:
165-1 - Rotational Crops PAIRA A Yes 00087692
(Confined)
165-2 - Rotational Crops TEP A Partial 000161568
(Field) • 000161569
165-3 - Irrigated Crops TEP — No
165-5 - In Fish PAIRA/TGAI A No
163-5 - In Aquatic TEP — No
Must Additional Timeframe for
Data Be Submitted? Submissionl/
YesH)/ 27 Months
No6/
NoJM/
NoJ_2/

Reservedl 3/
No
Yes^j4/ 50 Months
NoJIS/
Yesj_6/ 12 Months
No5/
          Nontarget
          Organisms

Monitoring Studies;

Soil, Water, Sediment,
  and Fish
TEP
No
Yes17/
6 Months
 (acceptable
 protocol)
                                                                                                                           ID

-------
                                                       Table A
                                   Generic Data Requirements for Terbufos (cont'd)

§158.290 Environmental Fate Footnotes

 I/ Due dates refer to the number of months following issuance of this Registration Standard unless otherwise
    indicated.
 2/ Full information is needed on light source spectral characteristics, use and effect of filters, and comparison
    with natural sunlight.  Also, the T 1/2 of the dark control vis a vis the hydrolysis T 1/2 and the pH of the
    solutions is needed before the study can be accepted.
 _3/ This study is required to support the current method of nonsoil-incorporated, broadcast (ground or aerially)
    application of the granular formulation.
 j4/ The study must be repeated due to low residue recoveries (material balance); also, the study should use terbufos
    i^C-labeled in two sites to detect all degradates.  The study is needed so that all the degradates present are
    known and can be looked for in the field dissipation study.
 5/ This study is not required to support the current use pattern which does not include aquatic, forestry, or
    aquatic impact uses.
 6/ This study is not required to support the current use pattern which does not include aquatic or aquatic impact
    uses.
 7/ This study must be repeated due to low residue recovery for the aged and imaged studies (< 60% of applied).  Such
    poor recovery prevents us from knowing if significant amounts of residues leached.  An aged column leaching study
    using sand or loamy sand plus one other representative soil is required.  Samples must be analyzed for both terbufos
    and its sulfone and sulfoxide degradates.
 8/ This study is required unless the vapor pressure of the TEP (granular formulation) is less than ICT^ mmHg.
 9/ This study is reserved pending the results of the lab volatility study.
10/ This study is required because of the many deficiencies of the reviewed studies, an important one being that the
    first sampling was taken 40 days posttreatment, by which time > 85% of terbufos dissipated.  This deficiency is
    important because of the lack of information we have on leaching, and its relatively long aerobic soil half-life
    for parent/degradates.  Samples were only taken to a depth of 6 inches and residues were present at the 3 to 6
    inch depth.   Samples must be analyzed for both terbufos and its sulfone and sulfoxide degradates.
ll/ This study is not required to support the current use pattern which does not include forestry uses.
12/ There are no current registered combination or tank mixes for terbufos.
13/ The requirement for this study is reserved pending the results of the field dissipation study (§164-1).
14/ The two studies may be acceptable provided sample storage stability data are supplied.
15/ This study is not required to support the current use pattern which does not include aquatic uses.
16/ This study must be repeated because the treated soil was aged 30 days before adding water and fish, the test
    material exceeded 1/10 LC50, and a flow-through system was not used to maintain a level concentration of
    terbufos.  The study is required to determine if accumulation in fish occurs since terbufos is very toxic to fish
    and the corn/sorghum use has the potential to reach fish in ponds.

-------
                                                       Table A
                                   Generic Data Requirements for Terbufos (cont'd)

§158.290 Environmental Fate Footnotes (cont'd)

17/ The objective of this monitoring requirement is to measure actual residues of terbufos and metabolites in treated
    fields and in ponds adjacent to fields where terbufos is used.
    The majority of terbufos marketed is used for corn rootworm control and it seems likely that environmental concerns
    will arise in the corn growing areas of the U.S.  The application sites chosen should possess a known application
    history and be adjacent to ponds.  Geographic areas for sampling should include:  corn belt States, plain States,
    and lake States.
    Soil in treated fields should be monitored before and after application of terbufos.  Pond water, sediment, and
    fish should be monitored before and after fields are treated with terbufos.  The scheme of monitoring (where,
    when, how) should reflect the attempt to measure maximum residues.  Fish samples should be analyzed for choline-
    sterase inhibition, as well as terbufos residues.  Baseline cholinesterase levels in fish brains should be
    established both in the ponds at the treatment sites and in an area without any history of anticholinesterase
    pesticide use (e.g., ponds near pastureland, but not where hay is harvested).  The pH-stat technique as described
    by Coppage (1971) should be used.  Metabolites as well as parent levels should be monitored (Cook, et al., 1976).
    Additional information on this type of field study can be found in Tagatz, et al.,  (1974) and Coppage and Braidech
    (1976).  Treatment rates should be at highest label rate for that site and crop.  Normal agricultural practices
    should be followed, including repeated applications, if appropriate.  If possible, some sites with a history of
    terbufos treatment should also be chosen.
    The monitoring protocol (including analytical methodology) must be submitted to the Agency, prior to initiating
    the study.

-------
               Table A
Generic Data Requirements for Terbufos
Data
§158.
Acute
81-1
81-2
81-3
81-7

Test
Requirement Substance
340 Toxicology
Testing:
- Acute Oral - Rat TGAI
- Acute Dermal - Rabbit TGAI
- Acute Inhalation - Rat TGAI
- Acute Delayed Neuro- TGAI
toxicity - Hen
Use Does EPA Bibliographic Must Additional Timeframe for
Pattern Have Data? Citation Data Be Submitted? Submission V
\
A Yes 00037467*, 00037471* No
000351 21**, 00029863**,
A Yes 00144805 No
A Yes 00144806 No£/
A Yes 00037472,00045379 No

Subchronic Testing:
82-1


82-2
82-3
82-4
82-5
- 90-Day Feeding
- Rodent TGAI
- Nonrodent TGAI
- 21 -Day Dermal TGAI
- 90 -Day Dermal TGAI
- 90-Day Inhalation TGAI
- 90-Day Neurotoxicity TGAI

A Yes 00109446,00037469 No
A No No3/
A Partial 00085169 YesjV 12 Months
A No NoV
A No No6/
A No NoV
                                                                                 o
                                                                                 VO

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                                                       Table A
                                        Generic Data Requirements  for  Terbufos  (cont'd)
Data Requirement
   Test        Use    Does EPA    Bibliographic
Substance    Pattern  Have Data?    Citation
Must Additional     Timeframe for
Data Be Submitted?  Submission"!/
§158.340 Toxicology

Chronic Testing:

83-1 - Chronic Toxicity


83-2


83-3


83-4
- Rodent
- Nonrodent
- Oncogenicity Study
- Rat
- Mouse
- Teratogenicity
- Rat
- Rabbit
- Reproduction
3-Generation
TGAI
TGAI

TGAI
TGAI

TGAI
TGAI
TGAI
A
A

A
A

A
A '
A
Yes
Yes

Yes
Yes

Yes
No
Yes
00045378,00049236
40089602
40374701,00161572

00045378,00049236
40089603

00147533

00085172,00037473
No8/
Nq9/

No
No

No
Yes
No
Mutagenicity Testing:
84-2
84-2
84-2
- Gene Mutation
- Chromosomal Aberration
- Other Mechanisms of
TGAI
TGAI
TGAI
A
A
A
Yes
Yes
Yes
00063209
00161570
00161571
No
No
No
                                                                                                   15 Months
         Mutagenicity

-------
                                                       Table A
                                        Generic Data Requirements for Terbufos  (cont'd)
                             Test        Use    Does EPA    Bibliographic     Must Additional      Timeframe for
Data Requirement	Substance    Pattern  Have Data?	Citation	Data Be Submitted?   Submissionl/

§158.340 Toxicology

Special Testing;

85-1 - General Metabolism   PAI or PAIRA  A       Yes       00087695                 No

85-2 - Domestic Animal         Choice     A       No           —                    No10/
         Safety

                                                                                                                           CNJ
 jy Due dates refer to the number of months following issuance of this Registration Standard unless otherwise              \O
    indicated.
 2/ A 21-day repeated inhalation study fulfills the acute requirements.
 3/ This study is not required because a long-term study is available.
 4/ The available 21-day dermal study in rabbits is acceptable.  However, an additional 21-day dermal study to be
    conducted with rats is required to support the registered use of terbufos as a nonsoil-incorporated application
    (using aerial or ground equipment) to corn.  Red blood cell and serum cholinesterase levels should be measured
    after the first dose and at study termination (21 days after the start of the study) in order to establish a
    cholinesterase NOEL.  In addition, brain cholinesterase levels should be measured at the time of terminal
    sacrifice (21 days).  Selection of dose levels is at the discretion of the registrant.
 5/ This study is not required to assess the dermal exposure associated with the current pesticidal use of terbufos.
 6/ This study is not required.  It is unlikely that the current pesticidal use of terbufos will involve repeated
    inhalation,  i.e., as granular formulations.
 ]_/ This test is not required because the results of the acute delayed neurotoxicity test were negative.
 8/ The 1-year rat study (40089602) combined with the 2-year rat study (00045378 and 00049236) satisfy this 83-1
    data requirement for the rodent.
 9/ A 4-week dog study submitted to establish a NOEL for plasma cholinesterase inhibition (40374701) combined
    with the 1-year dog study (0016175) satisfies this 83-1 data requirement for the nonrodent.
W/ Testing is not required based on current registered uses.  However, depending on the extent of future use in feed
    items and whether or not tolerances would be requested in meat and milk, a combined study can be performed for
    both residues and' domestic animal safety determinations.
  * Data citations 00037467 and 00037471, combined,  satisfy this data requirement for the technical material registered
    under EPA Registration No. 241-241.
 ** Data citations 00035121  and 00029863 satisfy this data requirement for the technical material currently pending
    under EPA File Symbol 2749-UEL.

-------
                                                       Table A
                                        Generic Data Requirements for Terbufos
Test Use Does EPA Bibliographic
Data Requirement Substance Pattern Have Data? Citation
Must Additional Timeframe for
Data Be Submitted? Submission1/
§158.390 Reentry Protection
132-1
132-2
133-3
133-4
- Foliar Dissipation TEP A Partial 00137760
- Soil Dissipation TEP A No
- Dermal Exposure TEP A Partial 00137760
- Inhalation Exposure TEP A Partial 00137760
Yes2/ 27 Months
NoV
NoV
NO4/
§158.440 Spray Drift

201-1  - Droplet Size Spectrum   TEP       A

202-1  - Drift Field Evaluation  TEP       A
                                                   No

                                                   No
                                                                                  No
                                                                                    V
                                                                                                                           \0
1/ Due dates refer to the number of months following issuance of this Registration Standard, unless otherwise
   indicated.
2/ The submitted study is acceptable for use in the estimation of field worker exposure to terbufos residues
~~  from application of the pesticide when applied in parts of the U.S. other than in California and the arid
   southwest.  A dislodgeable residue dissipation study  to be conducted in New Mexico is required to support
   continued use as an aerial or broadcast treatment in  the southwestern States, i.e., where rainfall is less
   than 25 inches/year.
3/ Soil dissipation data are not required for the current registered use of terbufos which does not include
   uses on crops such as potatoes or peanuts where hand  harvesting will be performed.
4/ Human-exposure monitoring data may be submitted at  the registrant's option.   If dermal exposure data are
   submitted, inhalation exposure data must also be submitted.
5/ These studies are not required to support the current application of turbufos as a granular formulation.

-------
                                                       Table A
                                        Generic Data Requirements  for  Terbufos
Data Requirement
   Test
Substance
  Use    Does EPA
Pattern  Have Data?
Bibliographic     Must Additional     Timeframe for
  Citation        Data Be Submitted?  Submission1/
§158.490 Wildlife and Aquatic Organisms

Avian and Mammalian Testing;

71-1 - Acute Avian Oral        TGAI
         Toxicity

71-2 - Avian Subacute Dietary

       - Upland Game Bird

       - Waterfowl

71-3 - Wild Mammal Toxicity

71-4 - Avian Reproduction
         Upland Game Bird
         and Waterfowl

71-5 - Simulated Field Testing
         and Actual Field
         Testing

       - Mammals and'Birds     TEP
72-1 - Freshwater Fish Toxicity

       - Coldwater Fish        TGAI
           Species             TEP
                A
                A
                        Yes
TGAI
TGAI
TGAI
TGAI
A
A
N/A
A
Yes
Yes
—
Yes
                        Partial
           Yes
           Yes
                     00106551
                                  00161573,00161574
                     00085178,00087726,
                     00085180,00145854,
                     00085179,00085183,
                     00131477
00087718,00037483
GS0109003
                                                           No
                                  00087717,00160387        No

                                  00035120                 No
                                              No
                         Yes2/
No
No
            December 31, 1989
              (1st Annual
              Report)3/

-------
                                                       Table A
                                        Generic Data Requirements for Terbufos (cont'd)
Test Use Does EPA Bibliographic Must Additional Timeframe for
Data Requirement Substance Pattern Have Data? Citation Data Be Submitted? Submissionl/
§158.490 Wildlife and Aquatic
72-1 -

Aquatic
72-2 -
72-3 -

72-4 -

72-5 -
72-6 -
Organisms

Freshwater Fish Toxicity (cont'd)
- Warmwater Fish
Species
Organism Testing:
Acute Toxicity to
Freshwater
Invertebrates
Acute Toxicity to
Estuarine and Marine
Organisms
Fish Early Life Stage
- Aquatic Invertebrate
Life Cycle
Fish - Life Cycle
TGAI A Yes 00087718,00037483,
00085176
TEP A Yes GS01 09002

TGAI A Yes 00101495,00085176
TEP A Yes GS01 09004
TGAI A No

TGAI A No
TGAI A • Yes 00162525
TGAI A No
Aquatic Organisms TGAI, PAI, or A No
No
No

No
No
Yes4/ 12 Months

Yes 15 Months
No
ReservedV
Yes 1 2 Months
         Accumulation     Degradation
                            Product

72-7 - Simulated Field
         Testing and Actual
         Field Testing
       - Aquatic Organisms
TEP
                   No
Yes6/
6 Months
  (Protocol)
                                                                                                                          in

-------
                                                        Table A
                                         Generic Data Requirements  for Terbufos  (cont'd)

 §158.490 Wildlife  and  Aquatic  Organisms  Footnotes  »

_!_/ Due dates  refer to  the number  of months  following issuance* of  this Registration Standard, unless otherwise
   indicated.
 2/ These data are  sufficient to satisfy  the Level  I  field  study requirement.  A Level II field study  is required to
   qualify the potential effects  on populations of birds,  mammals,  and reptiles, based on the adverse effects detected
   in the Level I  study.  The  Level II study must  be conducted on  corn to support the current registered uses on
   corn.  Field studies for other use patterns  are reserved,  pending  an evaluation of the results of  the corn study and
   an analysis of  applicability to support  other crop uses.   In the event the corn use is dropped, the study must be
   conducted on sorghum.
 3/ The submittal due dates were set in the  Agency  letter of  June 3, 1987 to American Cyanamid Co. and were subsequently
   extended in the  Agency's letter of May 9, 1988  to the company.
        1st Annual  Report   	  December 31,  1989
        2nd Annual  Report*	December 31,  1990                                                   ^Q
        3rd Annual  Report*	December 31,  1991                                                    \O
        Final Report**	December 31,  1992
    *A determination may be made  at this time to conclude  the study,  in which case a final report will be due
     3 months after notification.
   **This due date  applies if  the study has  not been determined to  be  concluded by earlier reviews.
4/ Though terbufos  appears to be  at least very  highly  toxic  to both sheepshead minnow and mysid shrimp in the available
   studies,  they are not acceptable because  of  deviation from recommended protocols and must be repeated.
5/ The need for this study is reserved pending  receipt of  lower tier  tests and environmental fate studies.
6/ Aquatic field studies are required to support the  corn  use.  Field  studies for other use patterns  are reserved,
   pending an evaluation of the results for corn and an analysis of applicability to support other crop uses.  For
   either mesocosm or full field studies, the study design must include  appropriate techniques to determine acute
   mortality and effects on productivity and diversity of  fish  and aquatic invertebrates.  A protocol for a mesocosm
   or full field study must be submitted to the Agency for review.  A  Guidance Document is available  from the Agency,
   which outlines  an acceptable approach to mesocosm studies.   This document also provides relevant,  although
   general,  guidance for full field studies, which,  if selected in place of mesocosm studies, must include multiple
   treated ponds and control ponds.  The Agency encourages registrants  to consult with Ecological Effects Branch
   staff for guidance as needed.

-------
                                                       Table A
                                        Generic Data Requirements for Terbufos
                             Test        Use    Does EPA    Bibliographic     Must Additional     Timeframe for
Data Requirement _ Substance    Pattern  Have Data? _ Citation _ Data Be Submitted?  Submissioni/

§158.590 Nontarget Insect

Nontarget Insect Testing - Pollinators :

141-1 - Honey Bee Acute       TGAI         A      Yes       00066220                 No
          Contact
141-2 - Honey Bee - Toxicity  TEP          A      No                                 Nq2/
          of Residues of
          Foliage

141-4 - Honey Bee Subacute    Reserved^/
          Feeding Study

141-5 - Field Testing for     TEP           A     No                                 No2/
          Pollinators

Nontarget Insect Testing - Aquatic Insects;

142-1 - Acute Toxicity to     Reserved^/
          Aquatic Insects

142-2 - Aquatic Insect Life   Reserved^/
          Cycle Study

142-3 - Simulated or Actual   Reserved^/
          Field Testing for
          Aquatic Insects

143-1 - NONTARGET INSECT      Reserved^/
thru    TESTING - PREDATORS
143-3   AND PARASITES

-------
                                                       Table A
                                        Generic Data Requirements for Terbufos  (cont'd)
§158.590 Product Chemistry Footnotes
_!/ Due dates refer to the number of months following issuance of this Registration Standard, unless otherwise
   indicated.
2/ Since the current registered uses of terbufos will not result in bee exposure, honey bee testing beyond the first
   level (acute contact LD50) is not required.
3/ Reserved pending development of test methodology.  Also refer to footnote^/.
4/ Reserved pending decision as to whether the data requirement should be established.
                                                                                                                          CO

-------
                                       Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Terbufos
Test
Data Requirement Substance
§158.190 Product Chemistry
Product Identity
61-1 - Product Identity and MP
Disclosure of Ingredients
61-2 - Description of Beginning MP
Materials and Manufacturing
Process
61-3 - Discussion of Formation MP
of Impurities
Use
Patterns
All
All
All
Does EPA Bibliographic Must Additional
Have Data?1/ Citation2/ Data Be Submitted?
No Yes4/
Partial 00147534 Yes5/
No YesjS/
Timef rame
for
Submissions/
6 Months
6 Months
6 Months
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to
Verify Certified Limits MP
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
63-4 - Odor MP
All
All
All
All
All
All
No Yes_7/
No YesjJ/
No Yes9/
No — YeslO/
No — YeslO/
No — Yes 1 0/
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
                                                                                                          ON

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                                           Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Terbufos (cont'd)
Test
Data Requirement ' Substance
Use
Patterns
Time frame
Does EPA Bibliographic Must Additional for
Have Data?1/ Citation2/ Data Be Submitted? Submissions/
§158.190 Product Chemistry
Physical and Chemical Characteristics (cont
63-7
63-8
63-9
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Other
64-1 -
- Density, Bulk Density,
or Specific Gravity
- Solubility
- Vapor Pressure
- PH
- Oxidizing or Reducing
Action
- Flammability
- Explodability
- Storage Stability
- Viscosity
- Miscibility
- Corrosion Characteristics
Requirements
Submittal of Samples
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
N/A
'd)
All
All
All
All
All
All
All
All
All
All
All

No
I/
V
No
No
No
No
No
No
No
No

YesJ_0/ 6 Months
J/ Yes 6 Months
J_/ Yes 6 Months
YesUy/H/ 6 Month
YesJK)/,J_2/ 6 Month
YesJ_0/,j_3/ 6 Months
Yes10/,14/ 6 Months
YesJHD/ 15 Months
Yes 1 0/ , 1 5/ 6 Months
YesJJV 6 Months
YesjH)/ 15 Months


-------
                                                       Table B
                               Product-Specific Data Requirements for Manufacturing-Use (cont'd)

§158.190 Product Chemistry Footnotes

 \J Although product chemistry data may have been submitted in the past, the Agency has determined that these data
    must be resubmitted for each pesticide.  New requirements have been introduced and previously submitted data must
    be updated.  Therefore, bibliographic citations for the old data are not applicable.
 2/ These data citations pertain to the terbufos manufacturing-use product currently registered under EPA Registration
    No. 241-241 and may not be applicable to manufacturing-use products which differ from that described herein.
 _3/ Due dates refer to the number of months following the issuance of this Registration Standard, unless otherwise
    indicated.
 _4/ The chemical name and nominal concentration of each impurity for which a certified limit is required must be
    submitted.  In addition, the chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number,
    and purpose of the active ingredient and each intentionally added inert must be provided.  For the active
    ingredient, the following must also be provided:  the product name, trade name, and common name; the                  -—
    molecular, structural, and empirical formulas; the molecular weight or weight range; and any experimental             f—
    or internally assigned company code numbers.
 S/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative
    amounts of beginning materials and the order in which they are added, the chemical equations for each intended
    reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration
    of each step of the process, purification procedures, and quality control measures.  In addition, the name and
    address of the manufacturer, producer, or supplier of each beginning material must be providedj>.,jalong with
    information regarding the properties of each beginning material used to manufacture each product.
 6/ A detailed discussion of all toxicologically significant impurities and all impurities that are or may be present
    at 2. 0.1%, based on knowledge of the beginning materials, chemical reactions (intended and side) in the manufac-
    turing process, and any contamination during and after production must be submitted.
 TJ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
    which a certified limit is required.  Complete validation data (accuracy, precision) must be submitted for each
    analytical method used.
 8/ Upper and lower limits for the active ingredient and each intentionally added inert, and upper limits for each
    impurity present at _>. 0.1% (w/w) and each "toxicologically significant" impurity present at < 0.1% (w/w) must
    be provided, certified, and validated by sample analysis using analytical procedures for which accuracy and
    precision data have been provided.  Limits for impurities not associated with the active ingredient need be
    provided only if they are considered to be of toxicological significance, regardless of the concentration at
    which they are present.  Certifications must be submitted on EPA Form 8570,  Rev. 2-85.
 9/ Analytical methods must be provided to determine the active ingredient, and each toxicologically significant
    impurity and intentionally added inert for which certified limits are required.  Each method must be
    accompanied by validation studies indicating its accuracy and precision.  These methods must be suitable
    for enforcement of certified limits.

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                                                       Table B
                             Product-Specific Data Requirements for Manufacturing-Use (cont'd)


§158.190 Product Chemistry Footnotes (cont'd)

10/ Physicochemical characteristics (color, physical state, odor, specific gravity,  pH,  oxidizing or reducing
    action, flammability, explodability, storage stability, viscosity, miscibilty,  and corrosion characteristics)
    as required in 40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D
    must be submitted.
11/ Required if the test substance is dispersible with water.
12/ Required if the product contains an oxidizing or reducing agent.
13/ Required if the product contains combustible liquids.
14/ Required if the product is potentially explosive.
IS/ Required if the product is a liquid.
                                                                                                                          OsJ

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Data Requirement
                                           Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Terbufos

                                                                                        Timeframe
                       Test         Does EPA     Bibliographic       Must Additional        for
        	Substance	Have Data?	Citation2/	 Data Be Submitted?   Submission 1/
§158.340 Toxicology

Acute Testing;

81-1 - Acute Oral - Rat
                        MP
Yes
00037467,00037471
                                                                                          No
                                                                                                                          K)
81-2
81-3
81-4
81-5
81-6
- Acute Dermal
- Acute Inhalation -
Rat
- Primary Eye Irritation -
Rabbit
- Primary Dermal Irritation
- Dermal Sensitization
MP
MP
MP
MP
MP
Yes 00144805
Yes 0001448063/
No
No
No
No
No
No4/
Nq4/
No4/
„*
•N-



_!/ Due dates refer to the number of months  following  issuance  of  this  Registration Standard,  unless  otherwise
   indicated.
2/ These data citations pertain to the manufacturing-use  (MP)  currently registered under  EPA  Registration
   No. 241-241, and may not be applicable to  MPs which  differ  from that described herein.
3/ A 21-day repeated inhalation study fulfills  the  acute  requirements.
4/ ThesB data are not required because mortality would  occur before sensitization or  irritation.

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II.  LABELING APPENDICES
                 74

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                          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 the table at the end of this Appendix.

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

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

      Item 3.   NET CONTENTS - A net contents statement  is required
 on  all  labels  or on  the  container  of  the  pesticide.    The
 preferred  location  is the bottom of  the front panel  immediately
 above the  company name and  address,  or  at the  end  of the label
 test.  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.  [40 CFR 162.lO(d)]

      Item  4.   EPA REGISTRATION NUMBER - The registration number
 assigned  to  the pesticide  product  must appear  on  the label,
 preceded by the  phrase  "EPA Registration No.," or "EPA Reg. No."
 The  registration  number  must be set  in  type of a size and style
 similar  to other print  on  that  part of  the label  on  which it
 appears and must run parallel to  it.  The  registration number and
 the  required  identifying phrase must not appear in  such  a manner
 as  to  suggest or  imply  recommendation  or endorsement  of the
 product by the Agency.   [40  CFR 162.10(e)]

      Item  5.   EPA  ESTABLISHMENT  NUMBER  - The EPA  establishment
 number, preceded by the  phrase "EPA Est." is the final estab-
 ment  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.
 [40 CFR 162.10(f)]                                         >
                                                          *•,

      Item  6A.   INGREDIENTS  STATEMENT -  An  ingredients  statement
 is required on the front panel.   The ingredients statement must
 contain  the   name  and  percentage   by   weight  of   each  active
 ingredient  and  the  total  percentage   by weight   of  all  inert
 ingredients.   The  preferred  location  is  immediately below the
product name.  The  ingredients statement must run parallel  with,
                                       75

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and be  clearly distinguished  from,  other text on the panel.   It
must not be placed in the body of other text.   [40  CFR 162.10(g)]

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

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

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

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

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

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

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

     Item  8.    SIDE/BACK  PANEL  PRECAUTIONARY  LABELING  -  The
precautionary statements listed below  must  appear  together on the
                                       76

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 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.   [40 CFR 162.10(h)(2)]

      Item  8A.   HAZARD TO HUMANS AND DOMESTIC  ANIMALS  - Where  a
 hazard  exists  to  humans   or   domestic  animals,  precautionary
 statements  are required  indicating  the particular  hazard,  the
 route(s)  of exposure  and the precautions to be taken to avoid
 accident,  injury or damage.   [40 CFR 162.10(h)(2)(i)]

      Item  8B.   ENVIRONMENTAL  HAZARD  - Where a hazard  exists to '
 non-target  organisms  excluding humans  and   domestic  animals,
 precautionary  statements  are required stating  the nature  of the
 hazard  and the   appropriate  precautions  to  avoid  potential
 accident,  injury, or damage.   [40 CFR 162.10(h)(2)(ii)]

      Item   8C.    PHYSICAL   OR   CHEMICAL HAZARD  -  FLAMMABILITY
 Precautionary  statements  relating  to flammability of  a product
 are  required to appear on the label  if  it meets the criteria in
 the  PHYS/CHEM Labeling Appendix.  The requirement is based on the
 results  of  the  flashpoint determinations  and  flame  extension
 tests required  to   be   submitted  for  all   products.    These
 statements  are  to be located in  the side/back panel precautionary
 statements  section,  preceded  by the  heading  "Physical/Chemical
 Hazards."   Note that  no  signal  word  is  used in conjunction with
 the  flammability statements.

      Item  9A.   RESTRICTED  USE CLASSIFICATION  -  FIFRA sec. 3 (d)
 requires  that  all pesticide formulations/uses  be classified for
 either  general  or  restricted  use.     Products classified  for
 restricted  use  may be limited to use by certified applicators or
 persons  under   their  direct  supervision  (or  may be  subject to
 other restrictions that may  be imposed by  regulation).

      In the Registration  Standard, the  Agency  has (1)  indicated
 certain  formulations/uses   are  to  be  restricted   (Section  IV
 indicates  why   the  product  has been classified  for  restricted
 use) ;  or  (2)   reserved   any   classification  decision  until
 appropriate data are submitted.

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

      If you do not believe that  your product  should be  classified
for   restricted  use,  you   must   submit  any  information  and
rationale with  your  application for  reregistration.    During the
                                       77

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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.

Classification Labeling Requirements

     If your product  has been  classified  for restricted use,  the
following label requirements apply:

     1.   All uses restricted.

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

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

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

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

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

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

     Item 9B.   MISUSE  STATEMENT  -  All  products  must bear the
                                        78

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misuse  statement,  "It is a violation of Federal  law  to use this
product  in  a  manner  inconsistent  with  its  labeling."    This
statement  appears at  the beginning of  the directions  for use,
directly beneath the heading of that section.


     Item  10A.   REENTRY STATEMENT -  If a  reentry  interval has
been established by the  Agency, it must be included on the label.
Additional  worker  protection  statements  may  be  required  in
accordance with PR Notice 83-2, March 29, 1983.

     Item  10B.    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  II,  STOR,
PEST/DIS,  and  CONT/DIS to  determine the  storage and disposal
instructions appropriate for your products.

     Item IOC.   DIRECTIONS FOR USE -  Directions  for use must be
stated  in  terms which  can  be easily read  and understood by the
average  person  likely to  sue  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.   [40 CFR 162.10]


                       COLLATERAL LABELING

     Bulletins,   leaflets,  circulars,  brochures,  data  sheets,
flyers,  or other  written  or graphic printed  matter  which is
referred to on the label or which is to accompany the product are
termed collateral labeling.  Such labeling may not bear claims or
representations that  differ in substance  from those accepted in
connection with  registration of the product.   It should be  made
part of the response to  this notice and submitted for  review.
                                          79

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ffVCAtmONAAV (TATtMCMTt

 HAIAMMTOMUMANt

 KOOMtmANMAUt
      fALHAUMM
 STORAGE AND
  DISPOSAL
RESTRICTED USE
   PESTICIDE
                        (reason for claanlfylnpj
                        * » MB m OMJT n ctmno JM
                        iNtn 0
      i OMJT n ctmno IMUCMOM
                        PRODUCT
                           NAME
                     ACtMl
                     TOTAU
                                      10000%
                     IMtPMOOUCtOONTAM* IM Vf rtM
                    KEEP OUT OF REACH OF CHILDREN
                       DANGER —POISON
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-------
                  SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Keg. No.
EPA Est. Nq.
Ingredients
statement
Pounds/ga 1 Ion
statement
Front panel
precautionary
statements
Keep Out of Reach
ot Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center tront
panel
Bottom front
panel or end
of label text
Bottom tront
panel or end
of label text
Front panel
Front panel,
immediately
bet ore or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
" i
Above signal
word
Immediately
below child
hazard
warning
COMMENTS

It registrant is not the producer, must
be qualified by "Packed tor • . . ,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units £
Must be in similar type size and run
parallel to other type.
May appear on the oxitainei instead ot
the label.
Text must run parallel with other text
on the panel.

All front panel precautionary statements
must be grouped together, preterably
blocked.
Note type size requirements.
Note type size requirements.

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SUMMARY-7
ITEM
7C
7D
7E
1 8
8A
UB
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement ot
Practical
Treatment or
First Aid
Referral
statement
i
Side/back panel
precaut ionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF RETIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxic ity
All products
in Categories
1, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, 11, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.

Top or side
of back panel '
preceding
directions
for use
Same as above
Same as above
COMMENTS
I
r*-
oc

Must be grouped under the headings in
BA, 8B, and 8C; preferably blocked.
Must be preceded by apptopriate signal
word.
Environmental hazards include hue
caution where applicable.

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SUMMAKY-8
ITEM
8C

9B
1QA
1UB
, 1UC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150»F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT UN LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading ot
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked

Immediately
after misuse
statement
Immediately
before
specific
directions
tor use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix 11 guide
PHYS/CHEM
Includes a statement ot the terms ot
restriction. The words '"RESTRICTED USE
PESTICIDE* must be same type size as
signal word.
Required statement is:
"It is a violation ot Federal law
to use this product in a mannei
inconsistent with its labeling."

Must be set apart and clearly distin-
guishable trom Irom other directions
tor use.
Refer to Appendix 11 guides STOR,
CONT/D1S, and PEST/DIS tor tutther
information and required statements.
May be in metric as well as U.S. units

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                                         40 CFR Ch. I (7-1-87 Edition)
Environmental Protection Agency
                            §162.10
00
cn
                                § 162.10  Labeling requirement*.
                                  (a)  General—(1)  Contents  of the
                                label. Every pesticide products  shall
                                bear a  label containing the Informa-
                                tion specified by the Act and the  regu-
                                lations In this Part. The contents of a
                                label  must  show  clearly and  promi-
                                nently the following:
                                  (I) The name, brand,  or  trademark
                                under which the product is sold as pre-
scribed  in  paragraph (b) of this  sec-
lion:
  (ID  The  name and address  of  the
producer,  registrant, or person  for
whom produced as prescribed in para-
graph (c) of this section:
  (iii) The net contents  as  prescribed
m paragraph (d) of this section;
  (iv)   The   product   registration
number as prescribed in paragraph (e)
of this section:
  
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00
o\
S 162.10

purposes other than as a pesticide or
drxicr.
  in i A false or misleading comparison
xuih oiher pesticides or devices:
   Any statement directly or indi-
rrrtly implying that the  pesticide or
device is recommended or endorsed by
any agency of the  Federal Govern-
ment:
  (4>.
  (c) Name and address of producer.
registrant,  or person  for whom  pro-
duced.  An  unqualified name  and ad-
dress given on the label shall  be  con-
sidered as the name and  address of the
producer. If the registrant's name ap-
pears on the label and the registrant Is
not the producer, or If the name of the
person  for whom the  pesticide  was
produced appears on the label, it must
be  qualified  by appropriate  wording
such as "Packed for •  •  V "Distribut-
ed by * * V or "Sold by	to show
that the name is not  that of  the pro-
ducer.
  (d) Net weight or measure  of  con-
tents. (1) The net weight or  measure
of content  shall be exclusive of wrap-
pers or other materials  and  shall be
the average  content unless explicitly
slated as a minimum quantity.
  (2) If  the  pesticide is  a  liquid. Ihe
net  content  statement  shall  be  in
terms of liquid measure at 68' F (20'C)
and shall be expressed In conventional
American unlls of fluid  ounces, pints.
quarts, and gallons.
  (3) If the pesticide  is  solid  or semi-
solid, viscous or pressurized,  or  is a
mixture  of liquid and solid,  the net
content statement shall  be In  terms of
weight   expressed   as   avoirdupois
pounds and ounces.
  (4) In all cases, net  content shall be
stated  in terms of the largest suitable
units, i.e.. "1  pound 10 ounces" rather
than "26 ounces."
  (5) In addition to the  required units
specified, net  content   may  be ex-
pressed in metric units.
  (6) Variation  above minimum  con-
lent or around an average Is permissi-
ble only to the extent  that It repre-
sents deviation  unavoidable  in good
manufacturing  practice.  Variation
below a stated minimum Is not permit-
ted. In no case shall the average con-
tent of the packages In a shipment fall
below the stated average content.
  (e)   Product  registration  number.
The registration number assigned  to
the pesticide product at the  time  of
 Environmental Protection Agency

 registration shall appear on the label.
 preceded  by the phrase "EPA Regis-
 tration No.." or the phrase "EPA Reg.
 No." The registration number shall be
 sel In type of a size and style similar lo
 other  print on lhat part of the label
 on which it appears and shall run par-
 allel lo il.  The registration  number
 and Ihe  required identifying  phrase
 shall nol  appear In such a manner as
 lo  suggesl or  Imply  recommendation
 or endorsement of the product by the
 Agency.
  (f) Producing establishments regis-
 tration number. The  producing estab-
 lishment  registration number preced-
 ed  by  the rjhrase "EPA Est.", of  the
 final establishment at which the prod-
 uct was produced may appear in any
 suitable location on the label or Imme-
 diate container. It must appear on the
 wrapper or outside  container  of  Ihe
 package If Ihe EPA establishment reg-
 istration  number  on  the  Immediate
 container  cannot  be  clearly read
 through such wrapper or container.
  (g) Ingredient statement—(I) Gener-
 al. The label of each pesticide  product
 must bear a statemenl which contains
 the name and percentage by weight of
 each active  Ingredient, Ihe total per-
 centage by welghl of all Inert  Ingredi-
 ents; and  If the pesticide contains ar-
 senic In any form, a statemenl of Ihe
 perccnlages of  total and water-soluble
 arsenic calculated  as elemental  ar-
 senic. The active ingredients  must be
 designated by the term "active  ingredi-
 ents" and the  Inert ingredients by Ihe
 lerm "Inert Ingredients," or the singu-
 lar forms  of these terms when appro-
 priate.   Both terms  shall be  in the
same lype size, be aligned lo Ihe same
 margin and be equally prominent. The
statement "Inert Ingredients, none" is
 nol required for pesticides which con-
 lain 100  percent  aciive Ingredients.
 Unless  Ihe Ingredient stalement  Is a
complete analysis of Ihe pesticide. Ihe
 term "analysis" shall not be used as a
 heading for the Ingredient statement.
  (2) Position of ingredient statement.
(I) The Ingredient stalement  is nor-
mally required on the front panel of
the label. If there Is  an outside con-
tainer  or  wrapper  through which the
Ingredient statement cannot be clearly
read, the  Ingredient statement  must
also appear on  such oulsidc conlainer
                            §162.10

 or wrapper. If Ihe size or form of the
 package  makes  it  impracticable  to
 place the Ingredient slatement on the
 front  panel  of the label, permission
 may  be  granted  for  the  Ingredient
 statemenl lo appear elsewhere.
   (II) The lexl of the Ingredient state-
 menl  musl  run parallel wilh  other
 text on the panel on which it appears.
 and must be  clearly  distinguishable
 from and musl nol be placed  in  the
 body of olher text.
   (3) Names  to be  used in ingredient
 statement. The name used for each in-
 gredient  shall   be   the  accepted
 common  name, if  there  is one,  fol-
 lowed by  the  chemical  name.  The
 common name may be used alone only
 if it is well known. If no common name
 has been  established.  Ihe chemical
 name alone shall be used. In  no case
 will Ihe use of a Irademark or proprie-
 tary name be permitted  unless such
 name has been accepted as a common
 name by the Administralor  under Ihe
 authority of seclion 25(c)(6).
   (4)  Statements of percentages.  The
 percenlages  of ingredients shall be
 stated in lerms  of  weight-to-weight.
 The sum  of percentages of the active
 and the inert  ingredients shall be 100.
 Percentages shall not be expressed by
 a  range of values such as "22-25%." If
 Ihe uses of Ihe pesliclde  producl  are
 expressed as  weight of active ingredi-
 ent per unit  area, a stalemenl  of the
 weight of active ingredienl per  unit
 volume of Ihe peslicide  formulation
 shall  also  appear in Ihe ingredient
 stalemenl.
  (5) Accuracy o/ stated percentages.
 The percenlages given shall be as pre-
 cise as possible reflecting  good  manu-
 facturing practice. If Ihere may be un-
 avoidable  variation belween  manufac-
 turing batches,  the value staled for
 each  active Ingredienl shall be  the
 lowest  percenlage  which  may  be
 presenl.
  (6) Deterioration. Pesllcides  which
change  In chemical  composilion  sig-
nlflcanlly  musl meel Ihe following la-
beling requirements:
  (I) In cases  where II is  determined
that a pesticide formulation changes
chemical  composition   significantly.
Ihe product must  bear Ihe  following
stalement in a prominent  position on

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          (he  label: "Not  for  sale or  use after
          (dale)."
            di) The product must meet all label
          claims up to the expiration time indi-
          cated on the label.
            (7) Inert  ingredients. The Adminis-
          trator may require the name of any
          inert ingredient(s) to be listed in the
          ingredient statement if he  determines
          that  such mgredienUs)  may  pose  a
          hazard to man or the environment.
            (h)  Warnings  and  precautionary
          statements.   Required  warnings  and
          precautionary  statements  concerning
          the  general  areas  of  lexicological
          hazard  including  hazard to  children,
          environmental hazard, and  physical or
 chemical hazard fall into two groups:
 those required on  the front panel of
 the  labeling  and  those  which  may
 appear  elsewhere.  Specific require-
 ments concerning content, placement,
 type  size,  and prominence  are  given
 below.
   (1) Required front panel statements.
 With  the   exception  of  the  child
 hazard warning statement, the text re-
 quired on the front panel of the label
 is determined by the Toxicity Catego-
 ry of the pesticide.  The category is as-
 signed on  the  basis  of  the  highest
 hazard shown by any of the indicators
 in the table below:
Hatard indicators
Oral ID-

inhalation LC_

Dermal L0_

Eye elf eels



b».ll ullucl>

Tokioty categories
1
Up 10 and including SO

Up 10 and including 2
trig/Met
Up 10 and including 200
mg/kg
Corrosive, cornea!
opacity nol reversible
within 7 days

Corrosive

II
From SO thru SOO mg/kg

From 2 thru 2 mg/kler

From 200 thru 2000

Corneal opacity
reversible wilhm 7
days, irritation
persisting lor 1 days
Severe irritation ai 72
hours
III
From SOO thru 5000 mg/
k«
Fiom 2 thru 20 mg/kter

From J 000 Inru 20.000

No corneal opacity.
ifntation reversible
wiirwi 7 days

Mouoialu irritation at 12
hours
IV
Greater than SOOO mg/
k8
Greater man 20 mg/htef

Creator than 20 000

No rnlalion



Mild or slight irnldlion al
72 hours
           (i) Human  hazard signal word—(A)
          Toncity Category I. All pesticide prod-
          ucts meeting the criteria  of  Toxicity
          Category  I shall  bear on the  front
          panel the signal word "Danger." In ad-
<-D       ditlon if the  product was  assigned  to
-•vj       Toxicity Category I on the basis of its
          oral, inhalation or dermal  toxlcity (as
          distinct  from  skin  and  eye local ef-
          fects) the  word "Poison" shall appear
          in red on  a background of distinctly
          contrasting color and the skull and
          crossbones shall appear In Immediate
          proximity to the word "poison."
           (B) Toxicity Category II. All  pesti-
          cide products meeting the criteria of
          Toxicity Category II shall  bear on the
          front panel  the signal word "Warn-
          ing."
           (C) Toxicity Category III. All pesti-
         cide products meeting the criteria of
         Toxicity Category III shall bear on
         the front panel the signal  word "Cau-
         tion."
           (D) Toxicity Category IV. All pesti-
         cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
  (E) Use of signal  words. Use of any
signal word(s) associated with a higher
Toxicity  Category  is  not  permitted
except  when the Agency determines
that such labeling Is necessary to pre-
vent  unreasonable adverse effects  on
man  or  the environment. In  no case
shall  more than  one  human  hazard
signal word appear on the front panel
of a label.
  (II)  Child hazard warning. Every pes-
ticide product label shall  bear on the
front panel the statement  "keep out of
reach  of  children."  Only  In  cases
where the likelihood of contact  with
children during distribution,  market-
ing, storage or use Is demonstrated  by
the applicant to be extremely  remote,
or if the nature of the pesticide Is such
that It is approved for use on Infants
or small children, may the Administra-
tor waive this requirement.
  (iii) Statement  of practical  treat-
ment—{At   Toxicity  Category  I.  A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
Ing  into  Toxicity  Category  I  on the
basis of oral, inhalation or dermal tox-
icily.  The  Agency  may,   however,
permit reasonable variations  In the
placement of the statement of practi-
cal treatment  is some reference such
as "See statement of  practical treat-
ment  on  back panel" appears  on the
front  panel near  the  word  "Poison"
and  the skull and crossbones.
  (B)  Other toxicity categories.  The
statement of practical treatment Is nol
required on the  front panel excepl as
described In paragraph (hXlHlllHA) of
this section. The applicant may, how-
ever, include such a front panel state-
ment  al   tils  option.  Statements of
practical  trealmenl are, however, re-
quired elsewhere   on  Ihe  label in
accord with paragraph (h)(2)  of Ihis
seclion if  ihey do nol appear  on the
front panel.
  (iv)  Placement and prominence. All
the require front panel warning state-
menu shall be  grouped  logether on
the label, and  shall appear with suffi-
cient  prominence  relative  lo  other
front panel  lexl and graphic material
lo make  them  unlikely  lo  be  over-
looked under customary conditions of
purchase  and use. The following table
shows the minimum type size require-
ments  for  the  front  panel warning
statements on  various sizes of labels:

Sue oc label ironi panel n square
metes
S and under
Above 5 lo 10
Above 10 to IS
Above IS 10 30
Over 30
Points
Required
signal
wort, all
capitals
6
10
12
14
ia
Keep oul
of reach ol
Children'
6
6
e
10
12
  (2) Other required warnings arid pre-
cautionary statements. The warnings
and precautionary  statements  as re-
quired below shall appear together on
the label under the general heading
"Precautionary   Statements"    and
under   appropriate  subheadings   of
"Hazard to Humans and Domestic Ani-
mals,"  "Environmental Hazard" and
"Physical or Chemical Hazard."
  (I) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals,  precau-
tionary statements are required indi-
cating   the  particular  hazard,  the
route(s) of exposure and  the  precau-
tions  to be  taken to  avoid accident.
Injury  or damage. The precautionary
paragraph shall be immediately pre-
ceded b'y the appropriate hazard signal
word.
  (B) The following table depicts typi-
cal precautionary statements.  These
statements  must  be modified or  ex-
panded to reflect specific hazards.
  ToiiCily
  category
                              Precautionary tuiementt by loudly category
                Oral, inhalation. Of dermal louctly


          Faui (poisonous) << swallowed Inhaled a absorbed
           through Hun] Do not wealne vapor Idutl or spray
           (null Oo not gel "* •>•* on skin, of on dolhng
           IFfonl panel statement ol piKUcal treatment re-
           quired I
          May be latai J swallowed (whaled  or absorbed
           through ine skin) Oo not breathe vapors (dust of
         I  spray mil) Oo nol gel •< eyes, on skm. of on
           doming (Appropriate toil ad »lelemenls required I
          HarmM i swallowed Inhaled of absorbed through ine
           skin) Avod breamng vapors Idusl of spfay nnsl)
           Avoid contact «nlh skin (eyes Of clollwigl (Appro-
           priate Itfsl aid statement recjuved I
          (No precaubona/y statements recjuMed I
             Skm and eye local eilecis


    Cofioswe. causes eye and  skin damagti  lor ik.n
     tfniaiion} Oo not gel m  eyes, on skm. or on
     clothing Wear goggles or  lace shield and rubber
     gloves when handling Hannlul or laul ii swallowed
     (Appfopnaie lifsl aid statement requtfed 1
    Causes eye land slun) irritation Oo nol get in eyes
     on skin. Of on clolhmg Hafmlul il swallowed [Ap
     prooriaie lifsl aid statement required 1

    AVON] contact with skm. eyes Of clothing In case ol
     contact vnmedialely llush eyes or skm with plenty ol
     watef  Gel medial attention il Mutation persists

    [No precautionary statements required ]
  (II) Environmental hazards. Where a
•hazard exists to non target organisms
excluding  humans and domestic ani-
mals, precautionary statements arc  re-
quired  slating  the  nature  of  the
hazard  and  the appropriate precau-
tions   to   avoid  potential  accident.
injury or  damage. Examples  of the

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CO
CD
           hazard  statements  and  the  circum-
           stances under which they are required
           follow:
            (A)  If a  pesticide intended for out-
           door use contains an active ingredient
           with a mammalian acute oral LDM of
           100 or less, the statement "This Pesti-
           cide is Toxic to Wildlife" is required.
            (B)  If a  pesticide intended for out-
           door use contains an active ingredient
           with a fish acute LC>. of 1 ppm or less.
           the statement "This Pesticide is Toxic
           to Fish" Is required.
            (C)  If a pesticide Intended for out-
           door use contains an active ingredient
           with an avian acute  oral LD»  of  100
           me/kg or less, or a subacute dietary
           LC,. of 500 ppm or less, the statement
           "This Pesticide is Toxic to Wildlife" Is
           required.
            (D) If either accident history or field
           studies  demonstrate  that  use of  the
                                         pesticide  may result in  fatality  to
                                         birds, fish or mammals, the statement
                                         "This pesticide is extremely toxic to
                                         wildlife (fish)" is required.
                                          (£) For uses involving foliar applica-
                                         tion  to  agricultural crops,  forests, or
                                         shade trees, or  for  mosquito  abate-
                                         ment  treatments, pesticides  toxic to
                                         pollinating insects must bear appropri-
                                         ate label cautions.
                                          (F) For  all outdoor uses other than
                                         aquatic  applications  the  label  must
                                         bear  the caution "Keep out of lakes,
                                         ponds or streams. Do not contaminate
                                         water by cleaning of equipment or  dis-
                                         posal of wastes."
                                          (lit) Physical or  chemical hazards.
                                         Warning statements on the flammabil-
                                         ity or explosive characteristics  of  the
                                         pesticide are required as follows:
                        Flash point
                                                               Reouued le»
                                        (A) PRCSSURUEO CONTAINERS
          Rain poml at or below 20* F
            any valve opening
                              il there is a flashback at
          * tavti point abo>e 20 f ano noi ovtn bO* F or it the
            llama ualwnnon is  moie man tb m long at a distance
            ol 6 in liom the llame
          Ail olnur uressuniod  conlameis
                                    Extremely flammable  Conlanls under pressure Keep away from
                                      lira sparks and heated surfaces Do not puncture or incinerate
                                      container  Exposure to temperatures above 130* F may cause
                                      txjr sling
                                    FiamrnaDbe  Contents under  pressure Keep away  Irom  heal.
                                      spa'ks anj open llame Do not puncture or incinerate container
                                      Exposure  to temperatures above  130* F  may cause bursting
                                    Contents under pressure Oo not use or store near heal or open
                                      llame Do not puncture or incinerate container  Exposure to
                                      temperatures above  130* F may cause bursting
                                       (B) NONpRESSuRizeo CONTAINERS
At 01 below 20' F
          Above 20' F and not over BO* F
          Above 80' F and not over ISO1 f
                                    Extremely flammable  Keep away I'ont lire sparks and healed
                                      surlaces
                                    Flammable Keep away Irom heal and open Dame
                                    Oo not use Of store near heal or open llame
            (i)  Directions  for Use—(I) General
          requirements—(I) Adequacy  and clar-
          ity of directions.  Directions for  use
          must be stated in terms which can be
          easily read and understood  by the av-
          erage person likely  to use or to super-
          vise the use of the pesticide. When fol-
          lowed, directions must be adequate to
          protect  the public  from  fraud  and
          from personal injury and to prevent
          unreasonable adverse  effects  on  the
          environment.
            (II) Placement  of  directions for use.
          Directions may appear on any portion
          of  the  label  provided  that they  are
          conspicuous enough to  be easily read
          by  the  user of  the pesticide product.
                                        Directions  for  use  may  appear  on
                                        printed or  graphic matter  which  ac-
                                        companies the pesticide provided that:
                                          (A) If required by the Agency, such
                                        printed or graphic matter is securely
                                        attached to each package  of the pesti-
                                        cide,  or  placed within  the  outside
                                        wrapper or bag;
                                          (B) The label bears a reference to
                                        the directions for use In accompanying
                                        leaflets or circulars,  such as "See  di-
                                        rections In the enclosed circular:" and
                                          (C) The  Administrator  determines
                                        that it is not necessary for such direc-
                                        tions to appear on the label.
                                          (Ill) Exceptions to  requirement for
                                        direction  for  use—(A) Detailed  direc-
 tions for use may be omitted from la-
 beling of pesticides which are intended
 for use only by manufacturers of prod-
 ucts other than pesticide products in
 their regular manufacturing processes.
 provided that:
  U> The label clearly shows that the
 product  is Intended  for use only in
 manufacturing processes and specifies
 the typeis) of products involved.
  12) Adequate Information such  as
 technical  data sheets or bulletins, is
 available to  the  trade  specifying  the
 type  of  product  Involved  and   its
 proper  use In manufacturing process-
 es;
  (J)  The-product will  not come Into
 the hands of the general public except
 after Incorporation Into finished prod-
 ucts: and
  (4)  The  Administrator determines
 that such directions are not necessary
 to  prevent  unreasonable  adverse ef-
 fects on man or the environment.
  (B) Detailed  directions for use may
 be omitted from the labeling of  pesti-
 cide products for which sale Is limited
 to  physicians, veterinarians,  or  drug-
 gists, provided that:
  (J) The label clearly states that  the
 product Is for use only by  physicians
 or veterinarians;
  ( The label  clearly stales  that the
 product Is  intended for  use only  In
 manufacturing, formulating, mixing.
 or repacking for use as a pesticide and
specifies the lype(s) of pesticide prod-
 ucts Involved;
  (J) The product as finally manufac-
 tured,  formulated, mixed, or  repack
 aged is registered; and
  (4)  The  Administrator  determine*
 that such directions are not necessary
 to  prevent  unreasonable  adverse  ef
 feels on man or the environment.
  (2) Contents  of Directions for  Use
 The directions for  use shall  includi
 the following, under the headings • Di
 rectlons for Use":
  (I) The slatement of use  classifica
 tion as prescribed  In 162.10(j) immedi
 ately  under the  heading  "Direction.1
 for Use."
  (II)  Immediately  below   the state
 ment of use classification, the state
 ment "It Is a violation  of Federal law
 to use this product In a manner incon
 slstent with Its labeling."
  (Ill) The slte(s) of application, as foi
 example the crops, animals, areas, 01
 objects to be treated.
  (Iv) The  target  pest(s)  associates
 with each site.
  (v) The dosage  rate associated wit)
 each site and pest.
  (vl) The method of application,  in
 eluding instructions for dilution, if rr
 quired, and type(s) of application ap
 paratus or equipment required.
  (vii) The frequency and timing of ap
 plications necessary to obtain effectivi
 results without causing unreasonable
 adverse effects on the environment.
  (viii)  Specific  limitations on recntr
 to areas where the pesticide has beei
 applied,  meeting  the  requirement
 concerning reentry  provided  by  
-------
   (C) Warnings as required against use
  on certain  crops, animals, objects, or
  in or adjacent to certain areas.
   (D) [Reserved]
   (E) For restricted use pesticides,  a
  statement that the pesticide may  be
  applied under the direct supervision of
  a certified applicator who is not phys-
  ically present at the site of application
  but   nonetheless  available  to   the
  person  applying the pesticide,  unless
  the  Agency has determined that  the
  pesticide  may  only  be applied  under
  the direct supervision of a certified ap-
  plicator who is  physically present.
   (P)  Other   pertinent  information
  which  the  Administrator determines
  to be necessary for  the protection  of
 man and the environment.
   (j) Statement of Use Classification.
 By October 22,  1976, all pesticide prod-
 ucts must bear on their labels a state-
 ment of use classification as described
 in paragraphs  (j) (1)  and (2) of this
 section.  Any   pesticide  product  for
 which some uses are classified for gen-
 eral  use and others  for restricted use
 shall be  separately,  labeled according
 to the  labeling standards set forth  in
 this subsection, and shall be marketed
 as separate products  with  different
 registration  numbers,  one bearing di-
 rections only for general use(s)  and
 the other  bearing  directions for  re-
 stricted use(s) except that, if a product
 has  both restricted use(s) and general
 use(s), both  of  these uses may appear
 on a product labeled  for restricted use.
 Such products shall  be subject to the
 provisions of § 162.10(j>(2).
  (1) General Use Classification.  Pesti-
 cide  products  bearing  directions for
 use(s) classified general  shall  be  la-
 beled with the  exact words "General
 Classification" Immediately below the
 heading "Directions for Use." And ref-
 erence  to  the   general  classification
 that suggests or implies that the gen-
 eral utility  of  the pesticide extends
 beyond those purposes and uses con-
 tained In the Directions for Use will be
 considered a false or misleading  state-
 ment under  the statutory definitions
 of misbranding.
  (2)  Restricted  Use  Classification.
Pesticide  products bearing direction
for use classified restricted  shall
bear statements of restricted use clas-
 sification  on the  front  panel as de-
 scribed below:
  (i) Front panel statement of restrict-
 ed use classification. (A) At the top of
 the front panel of the label, set in type
 of the same minimum sizes as required
 for human hazard signal  words (see
 table in § 162.10(h)UXiv)). and appear-
 ing with sufficient prominence relative
 to other text and graphic material on
 the front panel to make  it unlikely to
 be overlooked under customary condi-
 tions of purchase  and use.  the state-
 ment "Restricted  Use Pesticide" shall
 appear.
  (B) Directly below this statement on
 the front panel, a summary  statement
 of the terms of restriction imposed as
 a  precondition to  registration 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 per-
 sons under their direct supervision and
 only for those uses covered by the Cer-
 tified  Applicator's  certification." If,
 however, other regulatory restrictions
 are imposed,  the  Administrator will
 define the appropriate wording for the
 terms of restriction by regulation.
  (k) Advertising. [Reserved]

 [40 PR 28268. July  3. 1975: 40 PR 32329,
Aug. I. 1975: 40 PR 36571. Aug.  21.  1975, as
amended at 43 PR 5786. Feb. 9, 1978]
                                                    89

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                    PHYSICAL-CHEMICAL HAZARDS
Criteria

I.   Pressurized Containers
     A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
     B.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
         ALL OTHER PRESSURIZED
         CONTAINERS
II.  Non-Pressurized Containers

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

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

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

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

Contents under pressure.
Do not use or store near
heat or open flame.  Do
not puncture or incine-
rate 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.
                                       90

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               STORAGE INSTRUCTIONS FOR PESTICIDES

Heading;

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."

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.

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

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

6.   General  storage  instructions for household products should
     emphasize storage   in  original   container  and  placement in
     locked storage areas.
                                            91

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

     1.     Domestic  use products  must bear  one of  the  following
container disposal statements:
Container Type
                              Statement
(Non-aerosol products |Do not reuse container (bottle,  can,  jar).
I(bottles, cans. Jars)I Rinse thoroughly before discarding in trash.
|Non-aerosol products
I fbacrs)	
           Do not reuse bag.   Discard bag in trash.
[Aerosol products
          |Replace cap and discard containers in
          I trash.  Do not incinerate or puncture.
     2.
All  other  products   must  bear   container   disposal
instructions, based on container type,  listed below:
Container Type
                              Statement
 Metal
 containers
 (non-aerosol)
          |Triple rinse (or equivalent).   Then offer   |
         .Ifor recycling or reconditioning, or puncture)
          jand dispose of in a sanitary landfill, or by|
          j other procedures approved by state and local\
          I authorities.
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
1 cylinders
V Manufacturer may
(Triple rinse (or equivalent). Then offer |
(for recycling or reconditioning, or puncture)
. jand dispose of in a sanitary landfill, or .
(incineration, or, if allowed by state and
| local authorities, by burning. If burned,
(s^ay out of smoke «_
(Triple rinse (or equivalent). Then dispose
| of in a sanitary landfill or by other
(jrpproved state and^ local procedures.
| Completely empty liner by shaking and
(tapping sides and bottom to loosen clinging
(particles. Empty residue into application
(equipment. Then dispose of liner in a
(sanitary landfill or by incineration if
(allowed by state and local authorities.
(If drum is contaminated and cannot be
1 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
lout of smoke.
(Return empty cylinder for reuse (or
(similar wordina) .
replace this phrase with one indicating whether
   and how fiber drum may be reused.
                                            92

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                 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 that are
Acute Hazardous Wastes or are assigned to Toxicity Category I on
the basis  of oral or dermal toxicity,  or Toxicity Category I or
II  on  the  basis  of  acute inhalation toxicity  must  bear  the
following pesticide disposal statement:

     "Pesticide wastes are  acutely  hazardous.   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."

3.   The  labels  of  all  products,   except  those intended  for
domestic  use,  containing  active or  inert  ingredients  that are
Toxic Hazardous Wastes or meet any of the criteria  in 40 CFR 261,
Subpart C for a hazardous waste  must bear the  following pesticide
disposal statement:

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

4.   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."

5.   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."
                                           93

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III.   BIBLIOGRAPHY APPENDICES
                      94

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                  Guide to Use of This Bibliography

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

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

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

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

       a.   Author.     Whenever  the  Agency  could  confidently
            identify   one,  the   Agency  has   chosen  to   show   a
            personal author.   When no individual was
            identified, the Agency has 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
                                          95

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     date is followed  by  a question mark, the
     bibliographer deduced the date from evidence in
     the document.  When  the date appears as (19??),
     the Agency was unable to determine or estimate the
     date of the document.

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

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

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

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

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

     (4)  Volume Identification  (Accession Numbers).
          The final element  in the trailing  parentheses
          identifies the  EPA accession number of  the
          volume in which the original submission of
          the study appears.  The six-digit  accession
          number follows  the symbol  "CDL," standing for
          "Company Data Library."  This  accession
          number is in turn  followed by  an alphabetic
          suffix which shows the relative  position of
          the study within the volume.   For  example,
          within accession number 123456,  the  first
          study would  be  123456-A; the second,  123456-
          B; the 26th, 123456-Z; and the 27th,  123456-
          AA.
                                    96

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                      OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base  Supporting
             Registration Under the Revised Terbufos Standard
00029863      Consultox Laboratories  (1975) Acute Oral and  Percutaneous
                 Toxicity Evaluations.   (Unpublished study  received  Feb  3,
                 1976 under 2749-425; submitted by Aceto Chemical Co.,
                 Inc., Flushing, N. Y. ; CDL: 241 780-A)

00032636      Fischer, J.E. (1979) Toxicity Data Report: Report  No.  A79-109.
                 (Unpublished study received Jun 11, 1980 under  241-260;
                 submitted by American Cyanamid Co., Princeton,  N. J. ;
                 CDL:099451-B)

00032646      Palochak, M.E. ,• Shapiro, R. L. (1971) Microbiology  Laboratory
                 Report:  Report No. 710903M1.   (Unpublished study received
                 Jan 19,  1971 under 52-127; prepared in cooperation  with
                 Hudson Laboratories, Inc., submitted by West Chemical
                 Products, Inc., Lynbrook, N. Y. ; CDL: 000053-A)

00035120      Krize, J.W.-; Terrel Y.  (1978) Report: Avian Dietary LC50
                 (5-Day Dietary Exposure) of Enlist Technical  (Terbufos
                 Technical) EPA File  Symbol 2749-UEL to Mallard  Duck;
                 Laboratory No.  8E-3451.   (Unpublished study received
                 Mar 27,  1979 under 2749-425;  prepared by Cannon Labora-
                 tories,  Inc., submitted by Aceto Chemical  Co.,  Inc.,
                 Flushing, N.Y.; CDL:241730-A)

00035121      Parke, G. S. E. ; Terrell, Y. (1976) Acute Oral  Toxicity  in
                 Rats: Compound: Enlist  Technical Insecticide  (Terbufos)
                 EPA File Symbol 2749-UEL:  Laboratory No. 6E-3164.
                 (Unpublished study received Nov 29, 1976 under  2749-425;
                 prepared by Cannon Laboratories, Inc., submitted by
                 Aceto Chemical Co.,  Inc., Flushing, N.Y.;  CDL:241733-A)

00036123      Caballa,  S.H.; Ku, C.; Miller,  P.; et al. (1975) Summary—
                 Metabolism of Counter (CL 92,100) in Sugar Beets.   (Unpub-
                 lished study including project no. 2-404 and report
                 nos. C-698 and M-606, received Jun 10, 1975 under 5F1640;
                 submitted by America Cyanamid Co., Princeton, N.J.;
                 CDL:094445-G)

00036124      Higham, J.W.; Alvarez, C.G. ; Burhardt, C.C.;  et al. (1975)
                 General Summary:  Counter™(R)  15G Soil Insecticide Residues
                 in Sugar Beet Tops and  Roots.  (Unpublished study received
                 Jun 10,  1975 under 5F1640; submitted by American Cyanamid
                 Co., Princeton, N. J. ; CDL:094445-H)
                                                 97

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                       OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base Supporting
             Registration Under the Revised Terbufos Standard
00036127      Higham, J.W. ; Peterson, R. P. (1974) CL 92,100 and 92,100
                 Related Compounds:  Gas Chromatographic Procedure for the
                 Determination of CL 92,100 in Sugar Beet Tops (Greens)
                 and Roots.   Includes method M-395 dated Mar 1, 1973.
                 (Unpublished study including report no. C-532, received
                 Jun 10, 1975 under 5F1640; submitted by American Cyanamid
                 Co., Princeton, N.J.; CDL:094445-K)

00036129      Peterson,  R. P. ; McGinnis, R. A.  (1975) Counter (CL 92,100):
                 Total Counter-Related Residues in Sugar Beet Dried  Pulp
                 and Juice (Thick and Thin):   Report No. C-679.  Includes
                 method no. M-501 dated May 1, 1975.  (Unpublished study
                 received Jun 10, 1975 under 5F1640; prepared in cooperation
                 with Spreckels Sugar co., submitted by American Cyanamid
                 Co., Princeton, N.J.; CDL:094445-M.

00036241      Manuel, A. J. (1972) Total CL 92,100 and Its Metabolites in
                 Milk:  Report No. C-336.  Includes method M-353 dated Jul 31,
                 1972.   (Unpublished study received Apr 9, 1973 under 3G1340;
                 submitted by American Cyanamid Co., Princeton, N. J;
                 CDL: 093581-J)

00036242      Manuel, A.J. ; Peterson, R.P.; Potts, C.R.; et al. (1972)
                 CL 92,100 and Its Metabolites in Cattle Fat, Muscle,
                 Liver and Kidney: Report No. C-337.  Includes method
                 M-372 dated Nov 9,  1972.  (Unpublished study received
                 Apr 9,  1973 under 3G1340; submitted by American Cyanamid
                 Co., Princeton, N. J.; CDL:093581-K)

00036246      American Cyanamid Company (1972) CL-92100: Determination  of
                 Total CL-92100-Related Residues in Corn Forage and  Grain.
                 Method M336 dated Jun 21, 1972.  (Unpublished study received
                 Apr 9,  1973 under 3G1340; CDL: 093582-C)

00037467      American Cyanamid Company (1972) Toxicity Data: O, O-Diethyl-S
                 (tert-butylthiomethyl) phosphorodithioate Technical, 85.8%
                 AC  2162-42:  Report A-72-95.  (Unpublished study received
                 Apr 9,  1973 under 3G1340; CDL: 093584-B)

00037469      Sabol, R. J. ; Smith, J.M. ; Wilson,  N. H. ; et al. (1972)  A 3
                 and 24 Month Oral Toxicity and Carcinogenicity Study of
                 AC  92, 100 in Rats: Three Month Report: Project No.
                 71R-725.  (Unpublished study received Apr 9, 1973 under
                 3G1340; prepared by Bio/dynamics,  Inc., submitted by
                 American Cyanamid Co., Princeton,  N. J. ; CDL: 093584-D)
                                                   93

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                       OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base Supporting
             Registration Under the Revised Terbufos Standard
00037471      Kretchmar, B. (1972) Report to American Cyanamid: Acute
                 Oral Toxicity Studies with Two Samples in Female Albino
                 Rats: IBT No. A1373.  (Unpublished study received Apr
                 9, 11973 under 3G1340; prepared by Industrial Bio-Test
                 Laboratories, Inc., submitted by American Cyanamid
                 Co., Princeton,  N. J. ; CDL:093584-G)

00037472      Smith, J.H. ; Rosselet, C.; Cannelongo, B.; et al. (1972) A
                 Neurotoxicity Study of AC 92,100, an Organic Phosphate
                 Cholinesterase Inhibitor, in Hens: Project No. 72S-788.
                 (Unpublished study received Apr 9, 1973 under 3G1340;
                 prepared by Bio/dynamics, Inc.  submitted by American
                 Cyanamid Co., Princeton, N. J. ; CDL: 093584-H)

00037473      Smith, J.M.; Kasner, J.  (1972) Status Report for American
                 Cyanamid Company, November 28, 1972:  A Three Generation
                 Reproduction Study of AC 92,100 in Rats: Project No.
                 71R-727.  (Unpublished study received Apr 9, 1973 under
                 3G1340; prepared by Bio/dynamics,  Inc., submitted by
                 American Cyanamid Co., Princeton,  N. J.; CDL: 093584-1)

00037483      Sleight, B.H.,  III  (1972) The Acute Toxicity of Cycocel™(R) .
                 and Experimental Insecticide AC 92,100 to Bluegill
                 (Lepomis maclished study received  Apr 9, 1973 under
                 3G1340; prepared by Bionomics, Inc.,  submitted by
                 American Cyanamid Co., Princeton,  N. J. ; CDL: 093584-U)

00039018      American Cyanamid Company (1974)  General Summary:  Counter
                 Related Residues in Immature Corn Commodities from In-
                 Furrow Application of Counter™(R) 15G Soil Insecticide
                 at Planting.   Summary of studies 094895-D through
                 094895-G.   (Unpublished study received 1976 under 6F1657;
                 CDL:094895-C)
                                                99

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                       OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base Supporting
             Registration Under the Revised Terbufos Standard
00042017      American Cyanamid Company (1973) Summary—Counter-Related
                 Residues in Corn.  (Unpublished study received May  1,
                 1974 under 4F1496; CDL:091452-A)

00042019      Higham, J.W. ,- Manuel, A. J.;  Peterson, R. P. ; et al.  (1974)
                 Efficacy of Counter and Other Herbicides on Corn:
                 Report No. C-415.  Includes method M-336 dated Jun
                 21, 1972.  (Unpublished study including report nos.
                 C-416 and C-425,  received May 1, 1974 under 4F1496;
                 prepared in cooperation with Quality Control Laboratories
                 and others, submitted by American Cyanamid Co.,  Princeton,
                 N. J. ; CDL: 091452-C)

00042020      Higham, J.W. ; Manuel, A.J.;  Congleton, W.F. ; et al.  (1974)
                 Counter™(R) 15G:  Total Counter  (CL 92,100)-Related
                 Residues in Soybean Commodities: Immature Plant,
                 Harvest "Plant and Harvest Beans (Kansas and Iowa):
                 Report No. C-429.  Includes method M-480 dated Jan  9,
                 1974.  (Unpublished study received May 1, dustries  and
                 Iowa State Univ., Dept.  of Zoology & Entomology, submitted
                 by American Cyanamid Co., Princeton, N. J.; CDL:  091452-D)

00042021      Manuel, A. J. ; Elenewski, C. A. (1974) Counter (CL 92,100)
                 Stability of Residues in Counter-Treated Corn Grain
                 and Forage Samples When Stored in the Frozen State:
                 Report No. C-430.  Includes method M-336 dated Jun  21,
                 1972.  (Unpublished study received May 1, 1974 under
                 4F1496;  submitted by American Cyanamid Co., Princeton,
                 N. J. ; CDL: 091452-F)

00042022  .     Manuel, A.J. (1973) Counter (CL 92,100): Confirmatory Gas-
                  Liquid Chromatography Test for Counter Residues in
                  Corn Grain and Forage,  and in Animal Tissues: Report
                  No. C-379.  Includes method M-460 dated Sep 27, 1973.
                  (Unpublished study received May 1,  1974 under 4F1490;
                  submitted by American Cyanamid Co., Princeton,  N. J. ;
                  CDL:091452-G)
                                               too

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                      OFFICE OF PESTISCIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base  Supporting
             Registration Under the Revised Terbufos Standard
00045378     Smith, J.M.; Kasner, J.A.  (1973) Status Report for American
                Cyanamid—March 9, 1973; A Three and Twenty-Four Month
                Oral Toxicity and Carcinogenicity Study of AC  92,100 in
                Rats—11 Month Status of Eye Observations: Project  No.
                71R-725.  (Unpublished  study received Apr 9, 1973 under
                3G1340; prepared by Bio/dynamics, Inc., submitted by
                American Cyanamid Co.,  Princeton, N. J.; CDL: 093580-A)

00045379     Smith, J.M. ; Willigan, D. A. (1973) A Neurotoxicity Study of
                AC 92,100, an Organic Phosphate Cholinesterase Inhibitor
                in Hens: Project No.  72S-788.  (Addendum  I; unpublished
                study received Apr 9, 1973 under 3G1340; prepared by
                Bio/dynamics, Inc., submitted by American Cyanamid  Co.,
                Princeton, N. J. ; CDL: 093580-B)

00049235    Snyder, E. H. '(1975) Counterm(R) (CL 92,100): The Gas Chromato-
               graphic Determination of CL 92, 100  (0,0-Diethyl) SButyl-
               thiomethyl-phosphorodithioate)-Related Residue  in Fortified
               Barley, Green Beans, Red Beets and Wheat: Report No. C-730.
               (Unpublished study received Oct 9, 1975 under 241-238; sub-
               mitted by American Cyanamid Co., Princeton, N. J.;
               CDL: 224099-C)

00049236    Rapp, W.R.; Wilson, N. H. ; Mannion, M.; et al. (1974) A  Three
               and Twenty-Four Month Oral Toxicity and Carcinogenicity
               Study of AC 92,100 in Rats:  Project No. 71R-725.  (Unpub-
               lished study received May 29,  1975 under 241-238; prepared
               by Bi©dynamics, Inc., submitted by American Cyanamid Co.,
               Princeton,  N. J. ;  CDL:  224096-A)

00062871    Peterson, R. P. (1976) Counter™^) Insecticide 15-G and  Liquid
               (CL 92,100):  Metabolism of "14C-Labeled CL 92,100 ... in
               Cabbage Plants: PD-M 13-1:1-19.  (Unpublished study  received
               Nov 3, 1980 under 241-238; submitted by American Cyanamid
               Co., Princeton, N.J. ; CDL:099682-A)
                                              101

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                       OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base Supporting
             Registration Under the Revised Terbufos Standard
00062872    American Cyanamid Company (1976) Residue Studies in Cabbage,
               Broccoli and Cauliflower.  (Compilation;  unpublished
               study received Nov 3,  1980 under 241-238;  CDL:099682-B)

00063209    Allen, J.S.; Johnson, E.; Wainwright, C. (1977) Mutagenicity
               Testing of Technical Counter™(R) Soil Insecticide (Terbufos)
               in the Ames Test: AIR 5:419-431.  Final rept.  (Unpublished
               study received Apr 17, 1978 under 241-241; submitted by
               American Cyanamid Co., Princeton, N.J.; CDL:234103-B)

00066220    Atkins, E.L., Jr.; Anderson, L.D.;  Kellum, D.;  et al. (1976)
               Protecting Honey Bees from Pesticides.   ?:  Univ. of Cali-
               fornia, Div. of Agricultural Sciences.  (Leaflet 2883;
               also In unpublished submission received Mar 20, 1980
               under 432-502; submitted by Penick Corp.,  Lyndhurst,
               N.J.; CDL:243536-B)

00069512    North, H.H.; Barringer, D.F.; Gatterdam, P.E.;  et al. (1972)
               CL 92,100 Insecticide: Fate of C™14-Labeled CL 92,100 in
               Sweet Corn Plants: PDM 9:249-301.  (Unpublished study
               received on unknown date under 241-EX-59;  submitted by
               American Cyanamid Co., Princeton, N.J.; CDL:223458-X)

00079429    Chiu, T.Y.; Lucas, L.M.  (1981) Counter™^)  Terbufos
               (CL 92,100): 18-16:1-43.  (Unpublished study received Jul
               13, 1981 under 241-238; submitted by American Cyanamid
               Co., Princeton, N.J.;  CDL:070186-A)

00079430    American Cyanamid Company (1980) Residue Studies with Counter(R)
               15-G Soil Insecticide-Nematicide in Sorghum.  (Compilation;
               unpublished study received Jul 13, 1981 under 241-238;
               CDL:070186-B)

00079431     Peterson, R.P.; Good, T. (1979) Counter™(R)  Terbufos
                 (CL 92,100): Validation of GC Method M-0995 for the
                Determination of Total CL 92,100-Related Residues in
                Sorghum Tissues  (Silage, Fodder and Grain): Report No.
                C-1592.  Includes method M-995 dated Jul 11, 1979.
                 (Unpublished study received Jul 13, 1981  under 241238;
                submitted by American Cyanamid Co., Princeton, N.J.;
                CDL:  070186-C)
                                                     102

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                       OFFICE OF  PESTICIDE  PROGRAMS
                    REGISTRATION  STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base  Supporting
             Registration Under the Revised Terbufos Standard
00085169     Kruger, R. ,- Feinman, H. ;  (1973) 30-day Subacute  Dermal
                Toxicity in Rabbits of AC-92100: Laboratory No.  1611.
                (Unpublished study received May  1, 1974 under 4F1496;
                prepared by Food and Drug Research Laboratories,  Inc.,
                submitted by American Cyanamid Co., Princeton,  N. J. ;
                CDL:090808-J)

00085172     Smith, J.M.; Kasner, J.A. ; Wilson,  N.H. ; et al.  (1972) A
                Three Generation Reproduction Study of Pesticide
                AC 92,100 in Rats: Project No. 71R-727.  (Unpublished
                study received May 1, 1974 under 4F1496; prepared by
                Bio/dynamics, Inc., submitted by American Cyanamid Co.,
                Princeton,  N. J. ; CDL: 090808-M)

00085176     Bentley, R.E.  (1973) Acute Toxicity of Counter™(TM)  to Blue-
                gill (Lepomis macrochirus), Channel Catfish (Ictalurus
                punctatusO  and Crayfish (Procambarus clarkii).   (Unpub-
                lished study received May 1,  1974 under 4F1496; prepared
                by Bionomics, Inc., submitted by American Cyanamid Co.,
                Princeton,  N. J. ; CDL:090808-Q)

00085178   .   Labisky,  R.F.; Anderson, W.L. (1973) Effects of  Field Appli-
                 cations of Counter™(R) Soil Insecticide on Wildlife.
                 (Unpublished study received May 1, 1974 under 4F1496;
                 prepared by Illinois Natural History Survey,  submitted
                 by American Cyanamid Co., Princeton,  N. J. ; CDL:090808-T)
                                                   103

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                       OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base Supporting
             Registration Under the Revised Terbufos Standard
00085179      Labisky, R.F. (1974) Responses of Confined Hen Pheasants
                 to Simulated Field Applications of Counter™(R) Soil
                 Insecticide.  (Unpublished study received May 1,  1974
                 under 4F1496; prepared by Illinois Natural History
                 Survey, submitted by American Cyanamid Co., Princeton,
                 N. J. ; CDL-.090808-U)

00085180      Manuel,  A.J. (1973) Counter"(TM) 15G Soil Insecticide;
                 CL 92,100 and Its Metabolites in Wildlife Tissues and
                 Eggs: Report No. C377.  (Unpublished study received
                 May 1, 1974 under 4F1496; submitted by American Cyanamid
                 Co.,  Princeton,  N. J. ; CDL:  090808-V)

00085183      Manuel,  A.J. (1973) Counter™(TM) (CL 92,100) Related Residues
                 in Pheasant Muscle, Liver,  Skin, Kidney and Fat: Report
                 No. C378.  (Unpublished study received May 1,  1974
                 under 4FM496; submitted by American Cyanamid Co., Princeton,
                 N. J. ; CDL: 09 08 08-Y)

00087686      Higham,  J.W.; North, H.H. (1974) Counter™(R) 15G: CL 99875
                 (Metabolite 13)  Residue in Corn Silage and Fodder:
                 Report No. C-437.   (Unpublished study received May 1,
                 1974 under 4F1496; submitted by American Cyanamid Co.,
                 Princeton, N. J. ; CDL: 091 409-C )

00087687      Higham,  J.W. (1974) CL 99, 875:  The Determination of CL 99,875
                 in Corn Silage and  Fodder.   Method M-489 dated Feb 19,
                 1974.  (Unpublished study received May 1, 1974 under
                 4F1496; submitted by American Cyanamid Co., Princeton,
                 N. J. ; CDL:091409-D)

00087688      North, H.H.; Jenney, K. (1974) Counter"(R) Soil Insecticide:
                 Residue Levels and Metabolism in Sweet Corn Foliage
                 and Grain: Report No. 442.   (Unpublished study received
                 May 1, 1974 under 4F1496; submitted by American Cyanamid
                 Co.,  Princeton,  N. J. ; CDL: 091 409-E)

00087689      Barringer, D.F. ; Gatterdam,  P.; Steller, W.A. (1973)
                 CL 92,100 Counter™(R) Insecticide: The Identification
                 of the Major Metabolites  Found in Mature Sweet Corn
                 Plants and in Soil: PD-M 10: 423-454.  Progress rept.,
                 Jun 27, 1972 through Mar 30, 1973.   (Unpublished study
                 received May 1,  1974 under 4F1496; submitted by American
                 Cyanamid Co., Princeton,  N. J. ; CDL: 091409-F)
                                                     104

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                        OFFICE OF PESTICIDE PROGRAMS
                     REGISTRATION STANDARD BIBLIOGRAPHY
       Citations  Considered to be Part of the Data Base Supporting
              Registration  Under the Revised Terbufos Standard
 00087691       Caballa,  S. ;  Ku,  C. ;  Miller,  P.  (1973) Counter"^) Insecti-
                 cide  (15-G): Metabolism of W14C-Labeled CL 92,100 in
                 Sugar  Beets: Report No. C-405.   (Unpublished study
                 received May  1,  1974 under 4F1496;  submitted by American
                 Cyanamid Co.,  Princeton, N. J. ;  CDL: 091 409-H)

 00087692       Gatterdam, P.; Jenney,  K.  (1974) Counterm(R) Soil Insecticide:
                 Residue Levels in  Soybeans Grown as a Follow Crop on Soil
                 Previously Treated with W1 4C-CL 92,100:  Report No.  C-422.
                 (Unpublished study received  May 1,  1974 under 4F1496;
                 submitted  by American Cyanamid  Co.,  Princeton,  N.J.;
                 CDL;091409-1)

 00087694       Metabolic Studies of  ™14C-labeled  CL 92,100 in Hydrolytic
                 and Photolytic Environments: PD-M 10:959-1007.   Progress
                 rept., Apr 5,  1973 through Oct  15,  1973.   (Unpublished
                 study received May 1, 1974 under 4F1496;  submitted  by
                 American Cyanamid  Co.,  Princeton, N.J. ;  CDL:091409-K)

 00087695       North, H.H. (1973) Counter™(R)  Insecticide:  Rat Metabolism
                 of CL  92,  100  PD-M 10:1008-1080.   Progress rept., Mar
                 1, 1973 -through Sep  28,  1973.   (Unpublished study recieved
                 May 1, 1974 under  4F1496;  submitted by.American Cyanamid
                 Co., Princeton, N. J. ; CDL: 091409-L)

 00087702       Manuel, A.J.  (1973) CL  92,100 and  Its  Metabolites  in Chicken
                 Fat, Muscle, Liver,  Kidney, Skin, and Eggs:  Report  No.
                 C-372.  (Unpublished  study received  May  1,  1974 under
                 4F1496; submitted  by  American Cyanamid Co.,  Princeton,
                 N. J. ; CDL:  091 837-B)

 00087704       American Cyanamid Company  (1973) CL  92,100:  Determination
                 of Total CL 92,100 and  Oxidative  Metabolites  in Chicken
                 Fat, Muscle, Skin, Liver, and Kidney by  Gas  Liquid
                 Chromatography.  Method M-401 dated  Mar  15,  1973.
                 (Unpublished study received May  1,  1974  under 4F1496;
                 CDL: 091837-D)

00087717      Roberts, S. ; Wineholt, R. L. (1976) 81-day Dietary  LC50 Study
                 of Terbufos in Bobwhite  Quail and Mallard  Duck:  Laboratory
                 No. 6E3165.  (Unpublished  study received  Nov  24,  1976
                 under 2749-427; prepared by Cannon Laboratories,  Inc.,
                 submitted by Aceto Chemical Co.,  Inc., Flushing,  N.Y.;
                 CDL:226950-A)

00087718      Roberts, S.;  Wineholt, R.L. (1976) Static 96-hour  Toxicity
                 Study of  Terbufos in Bluegill Sunfish and  Brown  Trout:
                 Laboratory No.  6E-3166.   (Unpublished study received
                 Nov 24,  1976 under 2749-427; prepared by Cannon  Labora-
                 tories, Inc.,  submitted by Aceto  Chemical  Co.,  Inc.,
                 Flushing,  N. Y.  ; CDL: 226951 -A)
                                                   105

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                       OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base Supporting
             Registration Under the Revised Terbufos Standard
00087722      American Cyanamid Company (1972)  Residue of AC 92,100 in
                 Corn.  Includes method M-336 dated Jun 21, 1972.  (Com-
                 pilation;  unpublished study, including report nos.
                 C-335, 72-43, 82-47, received on unknown date under
                 241-EX-3;  CDL:123080-E)

00087724      American Cyanamid Company (1975)  [Residues of Counter(R)
                 15G in Corn and Popcorn],  Includes method M-336 dated
                 Jun 21, 1972.  (Compilation; unpublished study, including
                 report Nos. C-644, C-635, C-639 ..., received Apr 1,
                 1975 under 241-238; CDL:110506-B)

00087726      Wang, G.T. (1973) Letter sent to Harold H. Nau dated Jun
                 21, 1973:  Post-mortem examination—wildlife.  (Unpublished
                 study received on unknown date under unknown admin.
                 no.; submitted by American Cyanamid Co., Princeton,
                 N.J.; CDt:223457-A)

00088210      Chiu, T.; Lucas, L.; Goldenbaum,  L. (1981) Counter"1^)
                 Terbufos (CL 92,100): Metabolism of Carbon-14 Labeled
                 CL 92,100 in Soybean: Report No. PD-M 18-19:1-65.
                 (Unpublished study received Dec 1, 1981 under 241-238;
                 submitted by American Cyanamid Co., Princeton, N.J.;
                 CDL:070496-A)

00088211      American Cyanamic Company (1981)  General Summary: Counter
                 15-G.  (Compilation; unpublished study received Dec  1,
                 1981 under 241238; CDL:070496-B)

00101495      Boudreau, P.; Forbis, A.D.;  Franklin, L.; et al. (1982)
                 Acute Toxicity of Counter® Terbufos to Daphnia magna;
                 Static Acute Bioassay Report 28686.   (Unpublished
                 study received Apr 20, 1982 under 241-238; submitted
                 by American Cyanamid Co., Princeton, N.J., CDL:247247-C)

00106551      Fink, R.; Beavers, J.B.; Joiner, G.; et al.  (1982) Final
                 Report: Acute Oral LD50 — Bobwhite Quail: Counter®
                 Terbufos Technical: Project No. 130-133.   (Unpublished
                 study received Apr  20, 1982 under  241-238; submitted by
                 American Cyanamid Co., Princeton, N.J.; CDL:247247-B)

00109446      Daley,  I.; Rinehart, W.; Martin, A.  (1979) A Three Month
                 Feeding Study of Counter® Terbufos  Insecticide  in Rats:
                 Project No.  78-2343  (Unpublished  study received   ?     ,
                 1982 submitted by American  Cyanamid Co.,  Princeton,  N.J.;
                 CDL:  247985-A)
                                                 106

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                       OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base Supporting
             Registration Under the Revised Terbufos Standard
0129173
0131237
0131477
0133299
0137582
0137760
0142295
0144805
0144806
0147533
American Cyanamid Company (1980) Metabolism and Residues:
   Counter Soil Insecticide-nematicide:  Rape and Mustard.
   (Compilation; unpublished study received Jul 14, 1983
   under 241-272; CDL:071747-C)

Mangels, G.; Goldenbaum, L. (1983) Counter Terbufos (CL 92,100)
   Metabolism of Carbon-14 Labeled CL 92,100 in Wheat Grain:
   Project No. 0427.  (Unpublished study received Oct 3,
   1983 under 241-238; submitted by American Cyanamid Co.,
   Princeton, NJ; CDL:251414-C)

Labisky, R.  (1975) Responses of pheasants to simulated
   field applications of counter, an organophosphate
   insecticide.  Journal of Wildlife Management 39(1):
   174-178.  (Also in unpublished submission received Oct 6,
   1983 under 241-238; submitted by American Cyanamid Co.,
   Princeton", NJ; CDL:251469-B)

American Cyanamid Co. (1983) Metabolism and Residues:  Counter
   Insecticide.  (Compilation; unpublished study received
   Nov 22, 1983 under 241-238; CDL:072150-A)

American Cyanamid Co. (1984) Metabolism and Residues:  Counter
   Soil Insecticide-nematicide in Corn Plants, Fodder and
   Grain.  (Compilation; unpublished study received Feb 9,
   1984 under 241-238; CDL:252421-A)

Peterson, R.; Picard, G.; Higham, J.; et al. (1984) Farm
   Worker Exposure Study with Aerial Application of Counter
   15-G:  Report No. C-2370.  (Unpublished study received
   Mar 21, 1984 under 241-238; submitted by American Cyanamid
   Co., Princeton, NJ; CDL:252762-A)
American Cyanamid Co.
   Unpublished study.
(1984)  [Product Chemistry for Counter],
 84 p.
Fischer, J. (1985) Rabbit Dermal LD5Q (Intact Skin):  Report
   No. A85-54.  Unpublished study prepared by American Cyanamid
   Co.  3 p.

Rusch, G. (1980) A Two Week Inhalation Toxicity Study of
   Technical Counter Terbufos in the Rat:  Project No. 78-
   7168.  Unpublished study prepared by Bio/Dynamics, Inc.
   346 p.

Rodwell, D. (1985) A Teratology Study with AC 92, 100 in Rats:
   Project No. WIL-35014:  Final Report.  Unpublished study
   prepared by WIL Research Laboratories, Inc.  212 p.
                                                     107

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                       OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base Supporting
             Registration Under the Revised Terbufos Standard
0147534       American Cyanamid Co.  (1983)  Sample Identification,  Purity
                 and Minor Component Profile [Counter Terbufos].  Unpublished
                 study.  28 p.

00156853      Peterson, R. (1983)  Counter Terbufos (CL 92,100):   Aerobic
                 and Anaerobic  Metabolism of CL 92,100 in a Silt Loam Soil:
                 Project No. 0402:  Report No.  PD-M Volume 20-4.  Unpublished
                 study prepared by American Cyanamid Co.  52 p.

0158614       Elenewski, C. (1983) Counter Terbufos (CL 92,100):  Validation
                 of GC Method M-1340 for the Determination of Total CL 92,100-
                 related Residues  in Whole Bananas:  Report No.  C-2260.
                 Unpublished study prepared by American Cyanamid Co.  13 p.

0160387       Beavers, J. (1984) A Dietary LC50 Study in the Bobwhite with
                 AC 92,100:  Final Report:   Project No. 130-134.  Unpublished
                 study prepared by Wildlife International Ltd.  18 p.

0161567       Mangels, G. (1986) Counter Insecticide, Terbufos (CL 92,100):
                 Water Photolysis:  Report No.  PD-M 23-19:  Project No. 0112.
                 Unpublished study prepared by American Cyanamid Co.  29 p.

00161568      Lee, T.; Belcher, D. (1986) Counter Terbufos (CL 92,100):
                 Residues of CL 92,100-related Compounds in Soil and Rotational
                 Crops  (Cabbage, Red Beets, and Wheat) from a Treated Corn
                 Field  (Waunakee,  WI, 1984) (C-1689, C-0532, C-0880, C-2642):
                 Report No. C-2658:   Project No. 0402.  Unpublished study
                 prepared by American Cyanamid Co.  28 p.

00161569      Lee, T.; Belcher, D. (1986) Counter Terbufos (CL 92,100):
                 Residues of CL 92,100-related Compounds in Soil and Rotational
                 Crops  (Cabbage, Sugar Beets, and Wheat) from a Treated Corn
                 Field  (York, NE,  1984)  (C-1689, C-0532, C-0880, C-2642):
                 Report No. C-2721:   Project No. 0403.  Unpublished study
                 prepared by American Cyanamid Co.  53 p.

00161570      Putman, D.  (1986) The Acute in vivo Cytogenetics Assay in Rats:
                 AC 92,100:  Final Report:  MA Study No. T4277.105002.
                 Unpublished study prepared by Microbiological Associates,
                 Inc.   44 p.

00161571      Mackenzie, K.  (1986) Dominant Lethal Study with AC 92,100 in
                 Rats:  Final Report:  Study No. 6123-137.  Unpublished
                 American Cyanamid Study No. 980-85-193 prepared by Hazleton
                 Laboratories America, Inc.  147 p.
                                                   108

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                       OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base Supporting
             Registration Under the Revised Terbufos Standard
00161572      Shellenberger, T. (1986) One-year Oral Toxicity Study in Purebred
                 Beagle Dogs with AC 92,100:  Final Report:  Report No. 8414.
                 Unpublished America Cyanamid Co.  Report No. 981-84-118
                 prepared by Tegeris Laboratories, Inc.  836 p.

00161573      Beavers, J. (1986) Counter Technical:  A One-generation
                 Reproduction Study with the Bobwhite (Colinus Virginianus
                 Final Report:  Project No. 130-137.  Unpublished study
                 prepared by Wildlife International Ltd.  129 p.

00161574      Beavers, J. (1986) Counter Technical:  A One-generation
                 Reproduction Study with the Mallard (Anas platyrhynchos):
                 Final Report:  Project No. 130-138.  Unpublished study
                 prepared by Wildlife International Ltd.  129 p.

00162525      Forbis, A.; Land, C.; Bunch, B. (1986) Chronic Toxicity of CL
                 92,100 to'Daphnia magna Under Flow-Through Test Conditions:
                 ABC Final Rept. #32891.  Unpublished study prepared by
                 Analytical Bio-Chemistry Laboratories, Inc.  164 p.

40089602      Daly, I. (1987) A One-year Dietary Toxicity Study with AC 92,100
                 in Rats:  Chronic Toxicity in Rats:-  Project No. 85-2964.
                 Unpublished study prepared by Bio/dynamics, Inc.  1604 p.

40089603      Shellenberger, T. (1986) Chronic Dietary Toxicity and
                 Oncogenicity Study with AC 92,100 in Mice:  Chronic Toxicity
                 and Oncogenicity—Mouse:  Laboratory Project ID. 8422.
                 Unpublished study prepared by Tegeris Laboratories, Inc.
                 1566 p.

4034701       American Cyanamid Company (1987) 28-Day Oral Toxicity Study in
                 the Dog with AC 92,100:  Unpublished study received Oct 14,
                 1987 under 241-241.

GS0109001     American Cyanamid Company.  Residue Studies for the Use
                 of Counter® 15G As a Cultivation Time Application for
                 Control of Corn Rootworms.  (Unpublished study re-
                 ceived Nov 10, 1977 under 241-238; CDL:232258)

GS0109002     U.S. Environmental Protection Agency (1975).  Report on
                 the Toxicity of Counter® 15G to Bluegill Sunfish.
                 Static Jar, Test No. 894, Nov 7, 1975; (unpublished
                 study prepared by U.S. EPA Chemical and Biological
                 Investigations Branch, Beltsville, MD)

GS0109003     U.S. Environmental Protection Agency (1975).  Report on
                 the Toxicity of Counter® 15G to Rainbow Trout.  Static
                 Jar, Test No. 909, Dec 12, 1975; (unpublished study
                 prepared by U.S. EPA Chemical and Biological
                                                     109

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                       OFFICE OF PESTICIDE PROGRAMS
                    REGISTRATION STANDARD BIBLIOGRAPHY
       Citations Considered to be Part of the Data Base Supporting
             Registration Under the Revised Terbufos  Standard
GS0109004     U.S.  Environmental Protection Agency (1976).   Report on
                 the Toxicity of Counter® 1 5G to Daphnia magna.  Static
                 Jar, Test No. 922,  Feb 2,  1976; (unpublished study pre-
                 pared by U.S. EPA Chemical and Biological  Investigations
                 Branch, Beltsville, MD)
                                                  110

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IV.   FORMS APPENDICES
                 1  1

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                                                                               OMB  Approval  No.   2070-0057
                                                                               Expires   11/30/89
                  FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
                                                                                        EPA REGISTRATION NO.
  PRODUCT NAME
  APPLICANTS NAME
                                                                                        DATE GUIDANCE DOCUMENT ISSUED
   Wrrtf respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
   Guidance Document. I am responding in the following manner:
      O I. I will submit data in * timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or re not
           specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group. OECO
           Chemicals Testing Programme, I enclose the protocols that I will oe:
      D 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(8)(ii) to satisfy the following data
           requirements. The tests, and any required protocols, will be submitted to EPA by:
   NAME OF OTHER REGISTRANT
     O 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
           respect to the following data requirements:
     D 4.  I request that you amend my ngistration by deleting the following uses (this option is not available to applicants for new products):
     O 5. I request voluntary cancedatioa of the registration of this product (This option is not available ID applicants for new products.)
REGISTRANTS AUTHORIZED REPRESENTATIVE
EPA Form 8680-1
                                                      SIGNATURE
                                                                                                          DATE
                                                                                   112

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                                                                             OMB  A-pproval  No.
                                                                             Expires  11/30/89
                        2070-0057
 (To qutlify, certify ALL fouritamtl
                                         CERTIFICATION OF ATTEMPT TO ENTER
                                    INTO AN AGREEMENT WITH OTHER REGISTRANTS
                                              FOR DEVELOPMENT OF DATA
 1. I am duly authorized to represent the following firm(s) who are subject to the require-
   ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
   to submit data concerning the active ingredient:
                                                                                   GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
                                     NAME OF FIRM
                                                                                           EPA COMPANY NUMBER
 (This firm or group of firms is referred to below as "my firm".)
 2. My firm if willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
   into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
   items or data:
 3. My firm has offered in writing to enter into such an agreement. Copies of the offers are atuched. That offer w*s irrevocable and included an offer to be
   bound by an arbitration decision under FIFRA Section 3(c)(2MB)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
   to the following firm(s) on the following date(s):
                                    NAME OF FIRM
                                                                                              DATE OF OFFER
 However, none of those firm(s) accepted my offer.
 4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
   have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
   me  whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(8). (This statement
   does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
 TYPED NAME
EPA Form 8S80-6
                                                   SIGNATURE
                                                                             1  13

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                          PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
Date
Guidance Document for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test

Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor 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 MRID
Number or
EPA Accession
Number


















Submit-
ting
Data
(At-
tached)


















(For EPA Use Only)
Accession Numbers
Assigned






-

•









                                                   114

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Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1.
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
-
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
















I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
















Submit-
ting
Data
(At-
tached)
















(For EPA Use Only)
Accession Numbers
Assigned











*




115

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                                              OMB Approval No. 2070-0057
                                              Expiration Date 11/30/89

                          GENERIC DATA EXEMPTION STATEMENT
                                          •
 EPA Product Registration Number: 	

 Registrant's Name and Address:   	                            |
                                                                                             i
                                                                                             i
                                  	                            I

     As an authorized representative of the registrant of the product  identified             '
 above, I certify that:

     (1)  I have read and am familiar with the terms of the Notice from EPA dated
               concerning a requirement for submission of "generic" data on the
 active ingredient	named under FIFRA Section 3(c)(2)(B).

     (2)   My firm requests that EPA not suspend the registration of  our product,
 despite our lack of intent to submit the generic data in question,  on the grounds
 that the product contains the active ingredient solely as  the result of the
 incorporation into  the product of another product which contains that active
 ingredient, which is registered under FIFPA Section 3, and which is purchased by
 us from  another producer.

     (3)   An accurate Confidental Statement of Formula(CSF)  for the  above-identified
 product  is  attached to this statement.  That formula statement indicates, by
 company  name,  registration number, and product name, the source of  the subject
 active ingredient in my firm's product, or

 The CSF  dated	on file with EPA is complete, current and  accurate and
 contains the information requested on the current CSF Form No.  8570-4.  The
 registered  source(s)  of the above named active ingredient  in my product(s) is/are
	and their registration number (s)  is/are	.      .

     My  firm will apply for an amendment to the registration prior  to changing
 the source  of  the active ingredient in our product.

     (4)   I  understand,  and agree on behalf of my firm, that if at any time any
 portion  of  this Statement  is no longer true,  or if my firm  fails to comply with
 the undertakings made in this Statement, my firm's product's registration may be
 suspended under FIFRA Section 3(c)(2)(B).

     (5)   I  further understand that if my firm is granted a  generic data exemption
 for the  product,  my firm relies on the efforts of other persons to provide the
 Agency with the rectuired generic data.   If the registrant(s) who have committed
 to  generate and submit  the required data fail to take appropriate steps to meet
 reouirements or are no longer in compliance with this Notice's  data requirements,
the Agency  will consider that both they and my firm  are not in  compliance and
will normally initiate  proceedings to suspend the registrations of my firm's
product(s)  and  their  product(s),  unless my firm commits to  submit and submits
the recruired data in  the specified time frame.   I understand that, in such cases,
the Agency generally will  not grant a time extension for submitting the data.
Registrant's authorized representative:
                                              (Signature)

Dated:
                                                (Typed)
EPA Form 8570-27
                                                     116

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      2070-0060

                      CERTIFICATION WITH RESPECT TO CITATION OF DATA

         EPA  File Symbol/Reg.  No. 	-__  Date of application

         Name of  Product
        Applicant's Name and Address
           1.  This--application  is supported by all data submitted or cited in the
        application,   in addition, if cite-all options are indicated, this application
        is supported by all data in the Agency's files that concern the properties
        or effects of  this product or of any other product that is identical or
        substantially  similar, and that is one of the types of data that would be
        required to be submitted if this application sought the initial registration
        of a product of identical or similar composition and intended uses under
        the data requirements in effect on the date of approval of this application.

           2.  I certify that, for each s'tudy cited in support of this application
        for registration that is an exclusive use study, I have obtained the
        written permission of the original data submitter to cite that study.

           3.  I certify that, for each study cited in support of this application
        for registration that is not an exclusive use study:

            I have obtained the  written permission.of the original data suhroitter
            to cite that study?  or

            I have notified in writing the companies who have submitted data I have
            cited to support this application and have offered to:  (a) Pay compensation
            for those  data in accordance with section 3(c)(l)(D) and 3(c)(2)(D) of
            the Federal Insecticide, Fungicide and Rodenticide Act; and (b) Commence-
            negotiations to determine which data are subject to the compensation
            requirement of FIFRA and the arcount and terms of compensation due, if
            any-  The  companies  I have notified are:    (Check one)

               [ ]  All companies listed on the Pesticide Data Submitters List for
               all active ingredients contained in my product (Cite-all method or
               cite-all option under Selective Method). (Also sign the General
               Offer to Pay Statement below.)

               { ]  Those companies who have submitted the studies which I have
               cited (Selective  method)


            Date 	       Signature 	

                                         Title	
            General Offer to Pay;  I hereby offer and agree to pay compensation to
            other persons, with regard to the approval of this application, to the
            extent required by FIFRA sec. 3(c)(l)(D) and 3(c)(2)(D).
             Date 	          Signature

                                          Title
             EPA Form           (April 1985)
*U. S.COWERNItNT PRINTING Off ICE : 1998-516-002 |80043
                                                               1 17

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